Policy Approval Workflow

*Clinical Workgroup broadly includes any medical staff committee, nursing committee such as Patient Care Leadership Team, administrative committee, and/or other ad hoc workgroups. Alameda Health System CPC Executive Summary to Medical Executive Committee Policies and Procedures September 2020 Chair: Dr. Felicia Tornabene and Janet McInnes

TOPIC or Last Next review Document Purpose Summary of Changes History of Review TITLE OF POLICY Approved date after Owners Committee Date BOT approval

AHS System Wide Policies & Procedures 340B Health Emergency New Policy 08/2023 Vivian Nguyen, The purpose of this policy is to  Establish guidelines and  Departmental: Policy Manager, establish guidelines and best best practices to effectively 05/2020 Engineering practices to effectively monitor and monitor and ensure HRSA  CPC: 07/2020 Services ensure HRSA 340B regulatory 340B regulatory compliance  MEC: 07/2020 compliance during a Public Health  Admission of audible Emergency, as declared by the records due to health Public Health Officer or the emergency Secretary under section 319 of the  Lists how to maintain Public Health Service (PHS) Act. audible records  Application to all locations using 340B Adult Immunization 05/2019 08/2023 Steve Kilgore, To reduce morbidity and mortality  Expand existing policy for all  Departmental: Standardized Procedure Ambulatory, from vaccine preventable disease by adult vaccines; add revision 05/2020 Director of vaccinating adults who meet the date and reference  CPC: 05/2020 Nursing criteria established by the Centers  Include patient  MEC: 07/2020 for Disease Control and Prevention’s choice/consent Advisory Committee on authorization protocol Immunization Practices.  Reference compliance with California vaccine recording AHS Crisis Standard of New Policy 08/2023 Dr. David The purpose of this document is to  Principles and guidelines for  Departmental: Care – Resource English, Chief provide guidance on a triage epidemic/pandemic 04/2020 Allocation in Conditions of Med Informatics allocation system during a public  AHS System critical care  CPC: 05/2020 Absolute Scarcity Officer health emergency in the event that resources, triage, decisions  MEC: 05/2020 the demand for critical care resources (beds, ventilators, etc.) overwhelms the supply available within our region. AHS Pain Assessment 10/2019 11/2023 Jackie Ho, To safely address, monitor, adjust  Minor changes to comply  Departmental: and Management Pharm.D. communicate and develop pain with Joint Commission 07/2020 management plan to tailor pain relief elements of performance  Pharmacy and to patients individual needs.  Added tools in pain Therapeutics: management and created 08/2020 an addendum  CPC: 08/2020  Amend wording with  MEC: 08/2020 Ambulatory Care

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1/288 Alameda Health System CPC Executive Summary to Medical Executive Committee Policies and Procedures September 2020 Chair: Dr. Felicia Tornabene and Janet McInnes

TOPIC or Last Next review Document Purpose Summary of Changes History of Review TITLE OF POLICY Approved date after Owners Committee Date BOT approval

AHS Restraint and 05/2019 08/2023 Nilda Perez,  To provide guidance for  Approved with changes in  Departmental: Seclusion in Acute Care Director, staff use of restraints June CPC; attachment 05/2020 Policy and Procedure Regulatory and/or seclusion while errors discovered before  CPC: 08/2020 Affairs maintaining patient submission to MEC  MEC: 08/2020 safety and dignity.  Update to AHS policy  To provide guidance for staff  Updates to timing and so that patients are free from synced policy updates to restraints and/or seclusion, of attachments any form, imposed by staff as  Post Acute has separate a means of coercion, policy (being provided by discipline, convenience, or Gerrie) retaliation. Breach Notification Policy 09/2018 11/2023 Rick Kibler, Vice The purpose of this Breach  Updated to re-include  Departmental: President, Notification Policy is to provide language for people 07/2020 Compliance and guidance to Alameda Health System involved in breach  CPC: 08/2020 Audit (AHS) workforce members for notification  MEC: 08/2020 breach notification when an  Breach only reportable impermissible or unauthorized when compliance access, acquisition, use and/or determines a breach disclosure of patient protected health information (PHI) occurs. Breach notification will be carried out in compliance with the American Recovery and Reinvestment Act (ARRA)/Health Information Technology for Economic and Clinical Health Act (HITECH) as well as any other federal or state notification law. Charge Capture and New Policy 11/2023 Betsy The purpose of this policy is to  Provide a standard and  Departmental: Reconciliation Policy and Grossman, provide a standard and consistent consistent system-wide 08/2020 Procedure Director of system-wide guideline to validate guideline to validate that all  CPC: 08/2020 Revenue that all charges for procedures, charges for procedures,  MEC: 08/2020 Integrity drugs and/or supplies administered, drugs and/or supplies and physician services have been administered, and physician appropriately posted to the correct services have been patient account in the Epic system in appropriately posted to the a timely manner. This policy outlines correct patient account in expectations for charge capture and the EPIC in a timely manner charge reconciliation by clinical  Added appendices departments utilizing the tools and reports available.

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2/288 Alameda Health System CPC Executive Summary to Medical Executive Committee Policies and Procedures September 2020 Chair: Dr. Felicia Tornabene and Janet McInnes

TOPIC or Last Next review Document Purpose Summary of Changes History of Review TITLE OF POLICY Approved date after Owners Committee Date BOT approval

Charity Care Policy 07/2016 08/2023 April Bass, The purpose of this policy is to  Informational only  Departmental: Director, define the eligibility criteria for 03/2020 Admissions and Charity Care services and to  CPC: 04/2020 Registration provide administrative and  MEC: 04/2020 accounting guidelines to assist with the identification, classification, and reporting of patient accounts as charity care. Clinical and Educational New Policy 08/2023 Ashley Bitar, Providing residents with a sound  Amended to system policy  Departmental: Work Hours Director, academic and clinical education  Update policy statement 05/2020 Graduate must be carefully planned and  CPC: 06/2020 Medical balanced with concerns for patient  MEC: 07/2020 Education safety and resident well-being. Each training program must have a program-specific policy addressing clinical and educational work hours and a work hour tracking system that are in compliance with both ACGME requirements and Alameda Health System GME policies. It is the responsibility of the house staff to ensure that they are in compliance with their program’s policy and will be disciplined if they fail to do so. Accurate reporting is considered part of the ACGME “professionalism” competency. Disaster Preparedness 12/2017 08/2023 Sandra The Alameda Health System (AHS)  Minor updates to current  Departmental: Communication Williams, utilizes many different forms of system policy 05/2020 Director, communication devices during  CPC: 06/2020 Environmental normal business operations and  MEC: 07/2020 Health and mass casualty situations. AHS will Safety use redundant communication during a disaster to ensure a disaster to ensure appropriate stakeholders are kept informed. These forms of communication provide redundancy. We have categorized AHS communications in three groups: primary, secondary, and third level communications.

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3/288 Alameda Health System CPC Executive Summary to Medical Executive Committee Policies and Procedures September 2020 Chair: Dr. Felicia Tornabene and Janet McInnes

TOPIC or Last Next review Document Purpose Summary of Changes History of Review TITLE OF POLICY Approved date after Owners Committee Date BOT approval

Do Not Use List of 01/2020 11/2023 Priya Patel, To promote patient safety by  Triennial review  Departmental: Abbreviations Pharm.D. decreasing the potential for errors  No changes 07/2020 associated with the use of  Pharmacy and abbreviations. Therapeutics: 08/2020  CPC: 08/2020  MEC: 08/2020 Donations Policy 05/2003 11/2023 Ann Metzger, To assure donations are accounted  No revisions – triennial  Departmental: Vice President, for properly. review 04/2020 Finance;  CPC: 08/2020 Corporate  MEC: 08/2020 Controller Emergency Operations 06/2017 08/2023 Sandra The purpose of the Emergency  Describes interoperability  Departmental: Management Plan Williams, Operations Management Plan with county and first 05/2020 Director, (EOP) is to describe the coordinate responders  CPC: 06/2020 Environmental response and recovery to the wide  Describes high-level  MEC: 06/2020 Health and range of natural and man-made overview of indicators Safety events that may disrupt normal  Includes standard operating operations and require a pre- procedures planned response to internal and  Other policy is null and void external emergencies and disasters.  Integrated comments from The EOP highlights the basic eVote strategies and mechanisms Alameda Health System (AHS) will use to mobilize resources and conduct activities to support emergencies and disasters. External Notification Policy New Policy 08/2023 Rick Kibler, Vice Alameda Health System (AHS) may  Updates to communication  Departmental: President, disclose certain portions of a of patient requests for 04/2020 Compliance and patient’s Protected Health notification  CPC: 05/2020 Internal Audit Information (PHI) to persons  MEC: 05/2020 involved in the patient’s care, and/or use or disclose the patient’s PHI in order to notify (or assist in notifying) such persons of the patient’s admission to the hospital, location, general condition or death. Prior to using or disclosing such PHI except in limited circumstances described below, AHS must provide the patient an opportunity to object or agree to the use or disclosure.

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4/288 Alameda Health System CPC Executive Summary to Medical Executive Committee Policies and Procedures September 2020 Chair: Dr. Felicia Tornabene and Janet McInnes

TOPIC or Last Next review Document Purpose Summary of Changes History of Review TITLE OF POLICY Approved date after Owners Committee Date BOT approval

Guidelines for House Staff 03/2017 08/2023 Ashley Bitar, To ensure adequate and  Amended to system policy  Departmental: Corrective Action Director, professional quality of trainees in  Clarified acronyms 05/2020 Graduate Post-Graduate academic programs.  Clarified House Officer  CPC: 06/2020 Medical evaluations on probation  MEC: 07/2020 Education To provide a system to address House Staff Performance.

To provide a system to review disciplinary actions against House Staff members and ensure the principles of due process have been met. Hazard Vulnerability 09/2010 08/2023 Sandra Locate the four (4) Hazard  Minor updates to current  Departmental: Analysis – Directions for Williams, Vulnerability assessment tools that system policy 05/2020 Use Director, are labeled: Hazardous Materials,  CPC: 06/2020 Environmental Human Related, Naturally Occurring  MEC: 07/2020 Health and and Technological Events. Safety Hazard Vulnerability 10/2011 08/2023 Sandra Alameda Health System (AHS) must  Minor updates to current  Departmental: Analysis Williams, be prepared for a variety of disasters system policy 05/2020 Director, or emergency situations both natural  CPC: 06/2020 Environmental and man-made. In order to react to  MEC: 07/2020 Health and these disasters or emergencies, Safety AHS shall prepare and plan for the responses and reactions required in these situations. Health Care Decisions for 01/2013 08/2023 Dr. David This policy is designed to provide  Reviewed all processes  Departmental: Unrepresented Patients English, Chief uniformity and consistency across around approach to 05/2020 Medical AHS acute and post- acute system admitting patients  CPC: 06/2020 Informatics on the process for making ethically  Policy & procedure integral  MEC: 07/2020 Officer sound medical decisions for to medical staff utilization incapacitated unrepresented review committee patients.  Rick Kibler to work with Sheila on policy statement and other edits HR Section 1.00 -- Policy 04/2017 08/2023 Robyn Hodge, To state fundamental policies  Minor updates and removed  Departmental: 1.12 Employment Process Manager, Talent governing the employment process. reference to another policy 04/2020 Acquisition (Section 9)  CPC: 05/2020  Approved with changes to  MEC: 05/2020 Header (for AHS System) and Step 3 regarding resume submission

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5/288 Alameda Health System CPC Executive Summary to Medical Executive Committee Policies and Procedures September 2020 Chair: Dr. Felicia Tornabene and Janet McInnes

TOPIC or Last Next review Document Purpose Summary of Changes History of Review TITLE OF POLICY Approved date after Owners Committee Date BOT approval

Kaiser Oakland Highland New Policy 08/2023 Kevin Scott To define the parameters of the  Establish policy for program  Departmental: OBGYN Residency AHS Smith, Chair, professional graduate education  Residency expansion into 04/2020 Community Hospitals Maternal Child program provided through the Kaiser AHD  CPC: 05/2020 Health Oakland sponsored Highland Site  Presenting to CPC as  MEC: 05/2020 OB/GYN residency program, and instructed for approval the accompanying patient care process; need MEC activities that occur during the approval rotations at Highland Hospital, San Leandro Hospital and Alameda Hospital. Maintain, Expand, 04/2014 08/2023 Sandra This policy is intended to support  Minor updates to current  Departmental: Decrease, or Close Williams, business continuity and the system policy 05/2020 Services Director, Emergency Operations Plan by  CPC: 06/2020 Environmental assessing the impact on essential  MEC: 07/2020 Health and services before, during and after a Safety disaster. Medical Record Forms 10/2019 11/2023 Bernice Zander, To establish To establish and  Outlines AHS system  Departmental: Policy Director, Health implement procedures for the process for forms approval 07/2020 Information drafting, approval, issuance,  Forms included in Forms on  CPC: 08/2020 Management revision, amendment, and control of Demand, and forms include  MEC: 08/2020 all clinical forms to prevent barcode for inclusion in duplication of existing forms, EPIC promote cost containment and standardization, and advise form development as needed. Medication Administration: 2010 08/2023 Natalie Fan, In the event that an extravasation of  Minor revisions based on  Departmental: System Chemotherapy Pharm.D. a cytotoxic agent occurs, timely and Joint Commission 05/2020 Antidote for Extravasation appropriate management should be recommendations  Pharmacy and Management Policy acted upon in order to minimize  Comments from eVote: Therapeutics: tissue damage at the extravasation  Need Dates at top. Policy 05/2020 site. statement appears to be  CPC: 06/2020 Purpose. Is policy really to  MEC: 06/2020 minimize tissue damage at an extravasation site….?  Procedure 1g missing. Medication Borrowing and 10/2019 11/2023 Wei Vivian Lin, To describe the policies and  Address 340B issues  Departmental: Lending Policy Pharm.D. procedures for borrowing and  Rick sending policy 07/2020 loaning medication between the statement  CPC: 08/2020 following AHS Inpatient Hospital  MEC: 08/2020 Pharmacies

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6/288 Alameda Health System CPC Executive Summary to Medical Executive Committee Policies and Procedures September 2020 Chair: Dr. Felicia Tornabene and Janet McInnes

TOPIC or Last Next review Document Purpose Summary of Changes History of Review TITLE OF POLICY Approved date after Owners Committee Date BOT approval

Medications: Storage 08/2017 11/2023 Priya Patel, All AHS pharmacies and medication  Revised language for  Departmental: Pharm.D. rooms will maintain proper storage ambient room storage and 07/2020 requirements of pharmaceuticals, who monitors  Pharmacy and biologics and chemicals.  Added tables addressing Therapeutics: ranges and actions 08/2020  CPC: 08/2020  MEC: 08/2020 Nurse Telephone Advice 06/2017 08/2023 Steve Kilgore, To provide patient’s with evidence-  Expand approval protocols,  Departmental: Director of based, safe instruction regarding integrated health records, 04/2020 Nursing, appropriate level of care and health and references for nurse  CPC: 05/2020 Ambulatory care advice. telephone advice  MEC: 05/2020  Add Procedure header and move items #2, #3, and #4 from policies to procedures Pharmacy Disaster 09/2014 08/2023 Priya Patel, The Pharmacy Department will have  Sent for eVote in May  Departmental: Planning Policy Pharm.D. in place an emergency management  Minor revisions based on 05/2020 plan that will describe how to Joint Commission  Pharmacy and maintain and ensure effective recommendations Therapeutics: response to disaster and emergency  Comments from eVote: 05/2020 care.  Need Dates at top. Policy  CPC: 06/2020 statement appears to be  MEC: 06/2020 Purpose. Is policy really to minimize tissue damage at an extravasation site….?  Procedure 1g missing.

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TOPIC or Last Next review Document Purpose Summary of Changes History of Review TITLE OF POLICY Approved date after Owners Committee Date BOT approval

Probate Conservatorship New Policy 11/2023 Mavis Major, The purpose of this policy is to  To outline the process of  Departmental: Policy Manager, Care outline the steps necessary in the assessing patients who may 07/2020 Management process of seeking to obtain probate need protection due to their  CPC: 08/2020 conservatorship on behalf of an AHS inability to provide for their  MEC: 08/2020 patient for has been admitted to the own needs hospital for medical care but the capacity of the patient is in question. Care Management staff are at times faced with balancing the eligible adult’s right to self-determination and the responsibility to protect the adult who may not have the capacity to meet his/her basic needs. In some cases when all other options have been exhausted, it may be necessary to involve the court system when the adult lacks capacity to act in his/her own self- interest. Depending on the eligible adult’s circumstances, petitioning for guardianship and/or conservatorship may be the only option. The purpose of this policy is to provide guidance to Care management staff in initiating the probate conservatorship process. Resident Trust Fund 06/2020 08/2023 Melissa Wong The purpose of this policy is to  Controls in place to  Departmental: Accounts Policy and document the guidelines and delineate responsibility for 05/2020 Procedures procedures to administer the patient funds for resident  CPC: 06/2020 (resident) trust fund accounts in the  Insure enough controls in  MEC: 06/2020 Alameda Health System (AHS) place and clearly outlined facility locations.  Policy statement after purpose  Add information on departmental approvals

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8/288 Alameda Health System CPC Executive Summary to Medical Executive Committee Policies and Procedures September 2020 Chair: Dr. Felicia Tornabene and Janet McInnes

TOPIC or Last Next review Document Purpose Summary of Changes History of Review TITLE OF POLICY Approved date after Owners Committee Date BOT approval

Security Management 05/2020 08/2023 John Vallee, The Board of Trustees oversees and  Updated to AHS system  Departmental: Plan Director of reviews the development and policy 05/2020 Security implementation of the Environment  CPC: 06/2020 of Care Security Management  MEC: 07/2020 Program, in conjunction with the Vice President of Support Services and AHS Director of Security. Alameda County Sheriff’s Office (police services) and Allied Universal Security (AUS) provide security services to Alameda Health System-Highland Campus. AUS also provides security services in the following locations with the assistance of local law enforcement as needed. System Infusion Pump New Policy 11/2023 Priya Patel,  To safely address pain relief in a  Updated per July CPC  Departmental: Policy Pharm.D. timely manner. questions and feedback 06/2020  To monitor and evaluate the  Approved by VPs  Pharmacy and patient’s response to analgesia. Therapeutics:  To make adjustments as 07/2020 required for patient comfort.  CPC: 08/2020  To communicate and educate  MEC: 08/2020 patients and family in current pain management techniques.  To develop a patient care plan tailored to the patient’s individual needs. Highland Hospital Policies & Procedures Anesthesia Response to New Policy 11/2023 Heather Tilton, The purpose of this policy is to  Change in practice  Departmental: Level 1 Trauma Trauma outline the attendance expectations 07/2020 Activations Program for anesthesia providers for level 1  CPC: 08/2020 Manager trauma resuscitations. Anesthesia  MEC: 08/2020 providers provide a resource for emergency/challenging airways for critically injured patients. Additionally, by responding to trauma activations they can obtain advanced warning on emergency operative cases.

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9/288 Alameda Health System CPC Executive Summary to Medical Executive Committee Policies and Procedures September 2020 Chair: Dr. Felicia Tornabene and Janet McInnes

TOPIC or Last Next review Document Purpose Summary of Changes History of Review TITLE OF POLICY Approved date after Owners Committee Date BOT approval

Family Birthing Center 03/2104 08/2023 Karen Meyer, To promote the safe and  Periodic review revisions  Departmental: (FBC) Cervical Cerclage Clinical Nurse standardized placement of and updates 04/2020 Policy Specialist transvaginal cervical cerclage at the  CPC: 05/2020 Family Birthing Center (FBC) in  MEC: 05/2020 patients who are appropriate candidates. Family Birthing Center New Policy 11/2023 Christine To promote safe and effective use of  New practice for NICU  Departmental: (FBC) Intensive Care Delgado, continuous distending positive 07/2020 Nursery Continuous Clinical Nurse airway pressure (CPAP) via the  CPC: 08/2020 Positive Airway Pressure V, Labor and Fisher & Paykel Bubble system to  MEC: 08/2020 Delivery; the spontaneously breathing infant Karen Meyer, requiring respiratory support. Clinical Nurse Specialist Highland Outpatient 03/2020 11/2023 Nataliya Miller, Decrease calls to the emergency  Minor changes to comply  Departmental: Pharmacy Discharge Pharm.D. department and discharging with Joint Commission 07/2020 Orders and ED Discharge providers for routinely prescribed elements of performance  Pharmacy and Auto-Substitution Policy medications that are not covered by  Added tools in pain Therapeutics: insurance and therapeutic management and created 08/2020 alternatives are available within the an addendum  CPC: 08/2020 same medication class. This will in  Amend wording with  MEC: 08/2020 turn improve reimbursement of Ambulatory Care medications, improve patient adherence, and prevent gaps in treatment. Trauma Assessment and 01/2019 11/2023 Mavis Major, The purpose of this policy is to  Updates to provide a trauma  Departmental: Screening Policy Major, Care provide a trauma informed informed mechanism 07/2020 Management mechanism effectively and effectively and  CPC: 08/2020 compassionately address AHS compassionately address  MEC: 08/2020 patients who experience trauma. AHS patients who Furthermore, the goal of this policy experience trauma is to promote the understanding of trauma and its impact, and to provide trauma informed treatment and services in a systematic way throughout the AHS facilities.

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10/288 Alameda Health System CPC Executive Summary to Medical Executive Committee Policies and Procedures September 2020 Chair: Dr. Felicia Tornabene and Janet McInnes

TOPIC or Last Next review Document Purpose Summary of Changes History of Review TITLE OF POLICY Approved date after Owners Committee Date BOT approval

San Leandro Hospital Policies & Procedures Intravenous Admixture 06/2015 11/2023 Yi-Chih Peng, To ensure the quality, safety, and  Add statement on didactic  Departmental: Service (SLH) Pharm.D. regulatory compliance of all pharmaceutical calculations 07/2020 intravenous solutions administered requirement as  Pharmacy and to patients at the facility. recommended by State Therapeutics: Board of Pharmacy 08/2020  CPC: 08/2020  MEC: 08/2020 Medication Compounding 11/2015 11/2023 Yi-Chih Peng, To provide standardized guidelines  Add QuVA 503  Departmental: 1735 Compliance (SLH) Pharm.D. for complying with section 1735 and Compounding service into 07/2020 1751. the policy as recommended  Pharmacy and by State Board of Pharmacy Therapeutics: 08/2020  CPC: 08/2020  MEC: 08/2020 John George Psychiatric Hospital Policies & Procedures None N/A N/A N/A N/A  N/A  N/A Alameda Hospital Policies & Procedures Primary Stoke Center New Policy 08/2023 Ronica Shelton, The Primary Stroke Center  Outlines build items in  Departmental: Performance Improvement VP, Patient Performance Improvement Plan EPIC; reports/vitals, 04/2020 Plan Services; provides a framework to the stroke education, care  CPC: 05/2020 Michaele systematic approach of improving plan, best practice, stroke  MEC: 05/2020 Baxter, AHD care for stroke patients at Alameda certification Stroke Hospital Coordinator

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USE OF 340B DRUGS AND MAINTENANCE OF AUDITABLE RECORDS DURING HEALTH EMERGENCY

Department Pharmacy Effective Date 05/2020 Campus AHS System Date Revised 05/2020 Category Clinical Next Scheduled 08/2023 Review Document System 340B Manager Executive Chief Administrative Owner Responsible Officer/Chief Nurse Executive Printed copies are for reference only. Please refer to electronic copy for the latest version.

PURPOSE The purpose of this policy is to establish guidelines and best practices to effectively monitor and ensure HRSA 340B regulatory compliance during a Public Health Emergency, as declared by the Public Health Officer or the Secretary under section 319 of the Public Health Service (PHS) Act.

BACKGROUND HRSA recognizes and understands that circumstances surrounding a public health emergency may warrant additional flexibilities in 340B operations and documentation of compliance with 340B rules, particularly for 340B hospitals directly impacted by the emergency. If a 340B covered entity has a specific circumstance(s) where they believe their response to a Public Health Emergency may affect their compliance or eligibility in the 340B program, the covered entity is advised to contact the 340B Prime Vendor at 1-888-340-2787 or [email protected]. Below are general flexibilities, as recommended by HRSA, that covered entities should adhere to during a public health emergency.

POLICY It is the policy of Alameda Health System’s 340B Program to adhere to the provisions set forth in this policy—or the latest HRSA standards/guidance—during Public Health Emergency.

SCOPE 1. This policy applies to the AHS 340B Program Covered Entities/Child Sites identified below, and to all employees, medical staff members, volunteers, contractors, and residents (collectively hereinafter referred to as “AHS 340B Program” or “Covered Entity”). a. DSH050320: Alameda Heath System – Highland General Hospital b. DSH050320A: Alameda Health System – JGP Emergency (PES) c. DSH050211: Alameda Hospital d. DSH050211A: Alameda Hospital – Wound Care Clinic – AHD Wound Care Clinic e. CH09087B: Eastmont Wellness Center

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13/288 f. CH09087C: Newark Health Center g. CH09087W: Hayward Wellness Center

PROCEDURE If operational adjustments, including utilization of general flexibilities (e.g., GPO Purchases, Patient Eligibility, etc.), are warranted by a public health emergency, AHS’s 340B Program will adhere to the following: 1. HRSA Standards / Guidance a. The 340B Program Manager will (a) review the latest HRSA Standards / Guidance pertinent to the Public Health Emergency, and (b) consult with the Compliance Department and the Office of the General Counsel.

2. 340B Prime Vendor a. If there is/are specific circumstance(s) where the AHS 340B Program Manager believes that the AHS 340B Program’s response to a Public Health Emergency may affect their compliance or eligibility in the 340B program, the 340B Program Manager (or designee) will contact the 340B Prime Vendor at 1-888-340-2787 or [email protected].

3. Inventory Management a. Unless otherwise prohibited by the latest HRSA guidelines or standards, if a covered outpatient drug is not available at the 340B price during a public health emergency the AHS covered entity shall do the following: i. Purchase at WAC: All AHS covered entities will attempt to purchase the drug at wholesale acquisition cost (WAC) as the first alternative. ii. Purchase on GPO: If the drug is not available at WAC, AHS may use a GPO or GPO private label products as the last resort. b. All AHS covered entities should maintain appropriate documentation to demonstrate the inability to purchase a drug at 340B and WAC prices. Additionally, AHS covered entities will maintain records demonstrating that covered outpatient drugs purchased through the GPO at that sites are not utilized or otherwise transferred to the parent hospital or any outpatient facilities registered on the OPA 340B database.

4. 340B Patient Eligibility a. If a technology platform such as telehealth/telemedicine is used to deliver care to a new or existing patient during a public health emergency or if care is being provided in a new offsite location that is not registered in the Office of Pharmacy Affairs Information System (OPAIS), AHS covered entities need to keep auditable record and will describe how patient definition requirements are met, including: i. That the care is being provided by a health care professional employed by the hospital or under a contractual or other relationship or arrangement with the hospital (e.g., referral for consultation) such that responsibility for care remains with AHS covered entities; and ii. That AHS covered entities either owns the medical record or has joint access to the medical record with the professional providing the care.

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14/288 b. If an abbreviated health record such as a single form, telephone note or note page is maintained during a public health emergency, the record, at a minimum, identifies the patient, records the medical evaluation, including any testing, diagnosis, or clinical impressions, and the treatment provided or prescribed.

5. 340B Registration of Offsite Locations that Are Reimbursable on the Hospital Cost Report a. Circumstances surrounding a public health emergency may require that the hospital, in responding to community needs, furnish care to patients at new offsite locations that are reimbursable on the hospital cost report. Because of the demands on resources imposed by the public health emergency, the hospital may encounter difficulties in completing the registration of such facilities in the 340B Office of Pharmacy Affairs Information System (OPAIS) during the two-week registration period permitted per quarter.

b. For new offsite outpatient locations that AHS intends to register in OPAIS but is unable to timely register as a result of the public health emergency, AHS will reach out to HRSA to request immediate enrollment for the 340B program. HRSA will review and post a supplemental MEDICAID EXCLUSION FILE every Friday beginning April 10, 2020 to include a list of entities that have been approved for immediate enrollment. i. NOTE: 340B medication should not be used on non-340B AHS sites before the approval is received from HRSA.

6. Maintenance of Auditable Records a. General Rule: AHS will maintain auditable records for each eligible patient that receives a 340B drug during a public health emergency. b. Patient Eligibility: AHS will maintain auditable records in the Electronic Health Record system following every telemedicine or physical visit. All visits must be documented properly and maintained during a public health emergency even when a typical office visit is not feasible. Please refer to Section 4(b) on this policy for information to be included in audible records to satisfy patient eligibility requirements. c. Volunteers: When volunteer health professionals are providing health care, emergency documentation is generated to clearly demonstrate the relationship between the professional and AHS and that the AHS covered entity is responsible for the care provided. The documentation should be kept on file by the hospital and include: i. A description of the emergency nature of the situation. ii. The name and address of the volunteer; and iii. The volunteer’s relationship to each covered entity (hospital)/child site.

REFERENCES HRSA (Office of Pharmacy Affairs 340B OPAIS) Website – Coronavirus (COVID-19) Information page. Link: https://www.hrsa.gov/coronavirus

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15/288 APPROVALS

System Alameda AHS/Highland/John George/San Leandro Department Date: N/A 05/2020 05/2020 Pharmacy and Date: 06/2020 N/A N/A Therapeutics (P&T) Clinical Practice Date: 06/2020 N/A N/A Council (CPC) Medical Executive Date: 06/2020 07/2020 07/2020 Committee (MEC) Board of Trustees Date: N/A N/A

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IMMUNIZATION STANDARDIZED PROCEDURE IN ADULT CLINICS

Department Ambulatory Effective Date 02/2016 Campus AHS System Date Revised 05/2020 Category Clinical Next Scheduled Review 08/2023 Document Owner Ambulatory Director of Executive Responsible Chief Administrative Nursing Officer, Ambulatory Printed copies are for reference only. Please refer to electronic copy for the latest version.

PURPOSE To reduce morbidity and mortality from vaccine preventable disease by vaccinating adults who meet the criteria established by the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.

POLICY Under this Standardized Procedure RNs and LVNs in adult clinics at Alameda Health System may identify the need for and with patient consent, vaccinate adults following the criteria established by the current Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (for the immunizations listed below).

Immunizations may only be administered when a licensed independent provider (LIP) is on site and emergency response supplies are available to initiate treatment for anaphylaxis The nurse may confer with an LIP when there is a question regarding identifying the appropriate immunization, immunization timing, contraindication/precautions or concerns raised from patient screening. All immunizations given are linked through the Electronic Health Record to the California Immunization Registry.

IMMUNIZATIONS INCLUDED IN THIS PROCEDURE, DOSE AND ROUTE

Abbreviation Name Dose/Route IIV Influenza Inactivated 0.5ml/IM LAIV Live attenuated influenza vaccine 0.1ml in each nostril Td/Tdap Tetanus-diphtheria toxoids & acellular pertussis 0.5ml/IM vaccine MMR Measles, Mumps and Rubella vaccine 0.5ml/SQ or IM VAR Varicella vaccine 0.5ml/SQ RZV Zoster recombinant 0.5ml/IM ZVL Zoster 0.65ml/SQ HPV Human Papilloma Virus vaccine 0.5ml/IM PCV13 Pneumococcal conjugate 0.5ml/IM

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17/288 Abbreviation Name Dose/Route PPSV23 Pneumococcal polysaccharide 0.5ml/IM HepA Hepatitis A Vaccine 0.5ml/IM HepB Hepatitis B Vaccine 0.5ml/IM MenACWY Meningococcal A, C, W, Y 0.5ml/IM MenB Meningococcal B 0.5ml/IM HepA/HepB Hepatitis A and Hepatitis B combination (Twinrix) 1.0m/IM combo

PROCEDURE 1. Identify adults due for vaccine. Refer to current CDC immunization schedule and vaccines based on medical condition guidelines. Recommended Adult Immunization Schedule 19 years and older . Includes tables by age and medical condition. (https://www.cdc.gov/vaccines/schedules/downloads/adult/adult-combined-schedule.pdf )

2. The influenza vaccines (IIV and LAIV) may be administered to 18 years olds per this protocol in adult clinics according to CDC guidelines (all other vaccines in this protocol start at 19).

3. Screen for contraindications and precautions. a. Do not give immunization to an adult who has experienced a serious reaction (e.g., anaphylaxis) to a prior dose of the vaccine or to any of its components. See: CDC Guide to Immunization Ingredients. (https://www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/B/excipient- table-2.pdf) b. Pregnancy is contraindication for: MMR, VAR, LAIV, ZVL and delay until after pregnancy for HPV, RZV and MenB. c. Immunodeficiency is contraindication for: MMR, VAR, LAIV, ZVL. d. Precaution: Moderate or severe acute illness with or without fever e. Precaution: History of Guillain-Barré syndrome. f. Complete list can be found at: Guide to contraindications and precautions for commonly used vaccines. (http://www.immunize.org/catg.d/p3072a.pdf) g. Current Immunize.org screening questionnaire may be used. Immunize.org vaccine contrainidication questionnaire (http://www.immunize.org/catg.d/p4065.pdf) or Screening Checklist for Contradindications for Inactivated Influenza Vaccine (http://www.immunize.org/catg.d/p4066.pdf)

4. Provide Vaccine Information Statement. Provide all patients with a copy of the most current federal Vaccine Information Statement (VIS). You must document in the patient’s medical record the publication date of the VIS and the date it was given to the patient. Provide non- English speaking patients with a copy of the VIS in their native language, if available and preferred; these can be found at http://www.immunize.org/vis/.

5. Chose appropriate needle gauge and length and administer immunization.

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18/288 6. Document in medical record include site, route, dose, brand, lot# and expiration date.

7. Be prepared for management of a medical emergency related to the administration of vaccine. To prevent syncope, vaccinate patients while they are seated or lying down.

8. Report all adverse events following the administration of a vaccine by completing an occurrence report and to the federal Vaccine Adverse Event Reporting System (VAERS). To submit a VAERS report online (preferred) or to download a writable PDF form, go to https://vaers.hhs.gov/reportevent.html. Further assistance is available at (800) 822-7967.

9. RNs and LVNs must demonstrate competence in identification of vaccines due and screening for contraindications and precautions before they can independently identify the need to administer vaccines under this protocol.

REQUIREMENTS FOR THE RN/LVN 1. Current RN or LVN license to practice in the State of California

2. Three months experience in an ambulatory care setting

3. Completion of initial training specific to the identification and contraindications/precautions regarding the adult immunizations listed in this standardized procedure as designated by the AHS Ambulatory Director of Nursing. This requirement may be met by completion of an on- line or in-person training.

4. Initial training will include proctoring by a clinician (LIP or RN) experienced with adult immunization administration. The RN/LVN must present 6 cases for review prior to administration to the proctor to ensure correct choice of immunization with no contraindications.

5. Annual: Nurse supervisor or designee will evaluate the RN/LVNs competence through an annual performance appraisal along with feedback from colleagues and clinicians.

6. Follow-up (to initial or annual review): Areas requiring increased proficiency will be retrained and monitored by the nurse supervisor or designee at appropriate intervals until acceptable skill level is achieved.

7. The nursing supervisor shall maintain a list of staff demonstrating current competence.

METHOD OF PROCEDURE DEVELOPMENT/APPROVAL/REVIEW/REVISIONS 1. Standardized procedures are developed collaboratively by nurses, nurse managers, physicians and administrators.

2. This procedure is approved by Ambulatory Operations Council and Medical Executive Committee.

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3. This procedure is reviewed every three years or sooner if there is a significant change in practice by the AHS Medical Director and Director of Nursing.

4. All changes or additions are approved by the Ambulatory Operations Council.

REFERENCES 1. California Business and Professions Code, Division 2 Chapter 6.5. Vocational Nursing 2860.7

2. Standardized Procedure Guidelines, California Title 16 CCR Section 1474.

3. All CDC hyperlinks/references obtained July 2, 2019.

4. All Immunize.org references obtained July 2, 2019.

APPROVALS

System Alameda AHS/Highland/John George/San Leandro Department Date: N/A 05/2020 05/2020 Pharmacy and Date: N/A N/A N/A Therapeutics (P&T) Clinical Practice Date: 05/2020 N/A N/A Council (CPC) Medical Executive Date: N/A 07/2020 07/2020 Committee Board of Trustees Date: N/A N/A

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AHS CRISIS STANDARD OF CARE RESOURCE ALLOCATION IN CONDITIONS OF ABSOLUTE SCARCITY

Department All Effective Date 04/2020 Campus AHS System Date Revised 04/2020 Category Clinical Next Scheduled Review 08/2023 Document Associate Chief Medical Executive Responsible Chief Medical Officer Owner Officer Printed copies are for reference only. Please refer to electronic copy for the latest version.

Crisis Standard of Care Resource Allocation in Conditions of Absolute Scarcity Principles and Guidelines COVID-19 Outbreak Alameda Health System

Executive Summary

Introduction: The purpose of this document is to provide guidance on a triage allocation system during a public health emergency in the event that the demand for critical care resources (beds, ventilators, etc.) overwhelms the supply available within our region. These triage recommendations will be enacted only if: 1) critical care resources are to the point of becoming overwhelmed regionally despite taking all appropriate steps, including transferring to other facilities, to increase surge capacity to care for critically ill patients; and 2) the Public Health Officer or other regional authority has declared a public health emergency. This allocation framework is grounded in ethical obligations that include the duty to care, duty to steward scarce resources to optimize population health, distributive and procedural justice and transparency. It is consistent with existing national recommendations for how to allocate scarce resources in a crisis standard of care. Until any additional national, state, or county guidance is provided, this policy will serve as a guide for Alameda Health System during a crisis standard of care.

This document describes 1) the creation of triage teams to ensure consistent and unbiased decision making; 2) allocation criteria for initial allocation decisions and 3) reassessment criteria to determine whether ongoing provision of scarce critical care resources are justified for individual patients.

Section 1. Creation of triage teams: An impartial, objective and multidisciplinary team appears to be a universally accepted and encouraged form of making decisions regarding allocation of resources nationwide in settings of a public health emergency. Alameda Health System

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21/288 supports such a team to remove the burden of rationing decisions from the bedside care team. The following document will outline the roles and responsibilities of the triage teams.

Section 2. Allocation criteria for utilization of scarce resources: Consistent with current and accepted standards during public health emergencies, the primary goals of this allocation framework are to save lives and save life-years, enacted within the context of ensuring meaningful access for all patients, ensuring individualized patient assessments, and diminishing the negative effect of social inequalities that lessen some patients’ long-term life expectancy. All patients who meet usual medical indications for critical care services will be assigned a priority score using a 1-8 scale (lower scores indicate higher likelihood of benefit from critical care resources and will be given priority). The scoring system is derived from 1) patient’s likelihood of surviving to hospital discharge, assessed with an objective and validated measure of acute physiology (e.g., the SOFA score); and 2) presence of a severely limited life expectancy even if the patient survived the acute critical illness. Once priority scores have been calculated patients will be assigned to color-coded priority groups. All patients will be eligible to receive critical care services in accordance with their stated goals and wishes, regardless of their priority scores. Available critical care resources will be allocated according to priority groups with the availability of resources determining how many priority groups will receive critical care. Patients who are triaged to not receive ICU beds or services will be offered medical care including intensive symptom management and psychosocial support.

Section 3. Reassessment for ongoing provision of critical care resources: The triage team will conduct periodic reassessments of all patients receiving critical care services during times of crisis (i.e., not merely those initially triaged under the crisis standards). The timing of reassessments should be based on evolving understanding of typical disease trajectories and of the severity of the crisis. A multidimensional, individualized assessment should be used to quantify changes in patients’ conditions, such as recalculation of severity of illness scores, appraisal of new complications, and treating clinicians’ input. Patients showing improvement will continue to receive critical care services until the next assessment. Patients showing substantial clinical deterioration that portends a very low chance for survival will have critical care discontinued. These patients will receive medical care including intensive symptom management and psychosocial support. Where available, specialist palliative care teams will provide additional support and consultation.

Introduction and Ethical Considerations Introduction: Alameda Health System anticipates a surge in seriously and critically ill patients related to the Novel Coronavirus Disease-2019 (Covid19). This increase in demand of ICU-level care and services may result in shortages of these highly utilized resources, including materials, staffing and space. In response to this demand, Alameda Health System leadership, in conjunction with the Ethics Committee, has outlined a triage system to ensure equitable and just allocation of resources. The healthcare system has already begun to ensure identification of scarce resources, acquisition of additional supplies and personnel, and conservation of the materials identified with controlled distribution and re-allocation of resources when necessary.

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22/288 The healthcare system is also actively working on alternatives and work arounds for scarce resources.

When critical resources become substantially reduced or depleted, the adoption of crisis standard of care must follow. In this scenario, it is imperative that ethical standards remain at the cornerstone of decisions surrounding criteria for access to (and discharge from) ICU level of care. These criteria will not only be decided upon based on clinical appropriateness, but also by principles and concepts outlined below. These principles are a culmination of articles and statement pieces from various medical societies and healthcare systems and adopted here for use at Alameda Health System. It is our hope that these guidelines and policies are utilized at the county and regional level in order to assure just allocation of resources throughout our community. It is also important that all patients be treated equally, regardless of race, ethnicity, gender, disability, perceptions of quality of life, insurance or socioeconomic status, perceptions of social worth, immigration status, etc. AHS affirms its duty and moral obligation to care for our marginalized population.

If crucial resources become so scarce that they need to be allocated on a case-by-case basis, such decisions will be made by the System Triage Team. This Triage Team will consist of physicians, nurses and members of the Ethics Committee none of whom are intimately involved in the care of the patient. Roles and responsibilities, along with steps to activate said team are discussed in more detail below.

Ethical principles of the allocation framework: Consistent with accepted standards during public health emergencies, a goal of the allocation framework is to achieve benefit for populations of patients, often expressed as doing the greatest good for the greatest number. It should be noted that this goal is different from the traditional focus of medical ethics, which is centered on promoting the wellbeing of individual patients. In addition, the framework is designed to achieve the following: 1. To create meaningful access for all patients. All patients who are eligible for ICU services during ordinary circumstances remain eligible, and there are no exclusion criteria based on age, disabilities, or other factors. 2. To ensure that all patients receive individualized assessments by clinicians, based on the best available objective medical evidence. 3. To ensure that no one is denied care based on stereotypes, assessments of quality of life, or judgments about a person’s “worth” based on the presence or absence of disabilities or other factors. 4. To diminish the impact of social inequalities that negatively impact patients’ long-term life expectancy.

The four main guiding ethical principles in resource allocation during a public health emergency, which are universally accepted and will be the driving concepts embedded within this statement piece center around our duty to care, duty to steward resources, distributive and procedural justice and transparency.

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23/288 Ethical Principle Ethical Obligation

Duty to Care Fundamental obligation shared by providers to care for all patients. Duty to Steward Resources Providers duty to responsibly manage resources during periods of true scarcity Distributive Justice Requires that an allocation system be applied broadly and consistently to be fair to all Transparency Ensures that the process is open to feedback and revision, and promotes public trust

The allocation framework is guided by a multi-principle approach, based primarily on two considerations: 1) saving lives; and 2) saving life-years, both within the context of ensuring meaningful access for all patients and individualized patient assessments based on objective medical knowledge. Patients who are more likely to survive with intensive care are prioritized over patients who are less likely to survive with intensive care. Patients who do not have a severely limited near-term prognosis are given priority over those who are likely to die in the near-term from conditions in advanced stages, even if they survive the acute critical illness.

The allocation framework does not incorporate long-term life expectancy into priority scores. The reason is that doing so would unfairly disadvantage patients with a decreased long-term life expectancy from disabilities or from diseases exacerbated by social inequalities. Instead, the framework incorporates prognosis for near-term survival. An implication of this design choice is that the framework treats as equal all patients who are not in the late stages of a severe condition. For example, a patient expected to live 5 more years would receive equal priority for ICU treatment as a patient expected to live 65 more years. This step was taken to affirmatively diminish the impact of disabilities and social inequalities that negatively impact patients’ life expectancy.

No use of categorical exclusion criteria: The allocation framework does not categorically exclude any patients who, in usual circumstances, would be eligible for critical care resources. Instead, all patients are treated as eligible to receive critical care resources and are prioritized based on potential to benefit from those resources; the availability of critical care resources determines how many priority groups can receive critical care. There are compelling reasons to not use exclusion criteria. Alameda Health System wants to make clear that all individuals are “worth saving” and we have a duty and obligation to provide the best possible care in all instances. Moreover, categorical exclusions are too rigid to be used in a dynamic crisis, when ventilator shortages will likely surge and decline episodically during the pandemic. In addition, such exclusions violate a fundamental principle of public health ethics: use the means that are least restrictive to individual liberty to accomplish the public health goal. Categorical exclusions are not necessary because less restrictive approaches are feasible, such as allowing all patients to be eligible and giving priority to those most likely to benefit.

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24/288 In times of public health emergencies, Alameda Health System is committed to ensuring that the triage system does not disproportionately impact marginalized and vulnerable groups. Furthermore, this triage system will be utilized at the system level and affect all patients, not just those suffering from COVID-19.

Code Status for Critically Ill Patients: It is recognized that there is a highly controversial and charged debate regarding the effectiveness and utility of CPR in critically ill patients, specifically those suffering from acute respiratory failure associated with COVID-19. Alameda Health System does not endorse a blanket DNR policy for COVID-19 patients.

The ethical framework that helps guide shared-decision making during normal situations should still hold true in a public health emergency. However, there are ethical obligations that go beyond the individual in such extraordinary circumstances. Factors that take into account the safety and well-being of healthcare workers performing CPR along with the effectiveness of the treatment modality should be analyzed on a case-by-case basis. In situations in which the treating physician, in consultation with other physicians and specialists, agree that the potential risks to staff along with the potential burden to the patient outweigh the potential benefits to such an intervention, then this treatment modality should not be offered. In this situation, informed assent, in which the treating physician asks the patient/surrogate/family to allow them to make the code decision based on an individualized assessment of the persons’ disease process, comorbidities and anticipated clinical course may be more helpful and therapeutic than the traditional informed consent.

For patients with known or suspected COVID-19 infection, the benefits and burdens are even more nuanced. All patients who are Full Code deserve high quality CPR and post-ROSC care in order to make the intervention as effective as possible. Similarly, all responders who are performing duties surrounding BLS/ACLS protocols must be given access to and should wear all appropriate PPE (in accordance with hospital policy) in order to protect themselves and others from becoming ill. If one or both of these two priorities cannot be met, then CPR should not be undertaken.

Even if it may not be possible to provide critical care services to all patients who might be in need, our goal is to align with patients and families and to demonstrate our commitment to their care and well-being by emphasizing empathetic, direct, and transparent communication, proactively engaging in goals of care conversations, and actively utilizing the services of the palliative and spiritual care teams.

Section 1: Triage Team Composition, Activation, Process, Communication of Decision Making, and Appeals Process The Alameda Health System Triage Team will have responsibility to implement the allocation framework outlined in this policy. It is important to emphasize that patients’ treating physicians should not make triage decisions. The separation of the triage role from the clinical role is intended to enhance objectivity, avoid conflicts of commitments, and minimize moral distress.

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Triage Team Composition The triage team will be composed of:  One attending physician with general knowledge of critical care  One nurse leader  One member of the Ethics Committee

Within this group, a Triage Officer(s) could be elected and would take call to help make decisions that are more time sensitive than would be allowable for an entire assembly of the Triage Team. Any decisions made by the Triage Officer, without the entire Team, will be reviewed as soon as a meeting with the entire Triage Team is able to be coordinated.

Alameda Health System will maintain a collective group of physicians, nurses and Ethics Committee members with familiarity with the ethical implications associated with these delicate triage decisions.

The triage team members should function in shifts lasting no longer than 13 hours (to enable 30 minutes of overlap and handoffs on each end). Therefore, there should be two shifts per day to fully staff the triage function. Team decisions and supporting documentation should be reported daily to appropriate hospital leadership and incident command. Triage team members will be oriented to the Crisis Standard of Care Policy and its ethical framework, applying the allocation framework, communicating with clinicians and families about triage decisions, avoiding implicit bias, respecting disability rights, and diminishing the impact of social inequalities on health outcomes.

Alameda Health System recognizes that Triage Team members may be personally affected by the crisis, or suffering moral distress due to the demands of their role. If at any point in time a Triage Team member feels they are unable to fulfill their role, they can request to be excused from the Triage Team.

Activation of the Triage Team

Step 1: Public Health Officer or Incident Command Center activates “Crisis Standard of Care” Defined by lack of critical care beds, ventilators or other scarce resource throughout the region and to begin allocation of said resources on a triage basis

Step 2: The ICU attending(s), with the help of the ICU charge nurse, will assign all critical care patients a raw priority score and give them the appropriate Color Code

Step 3: Incident Command Center activates the Triage Team

Triage Team Process • Triage Team convenes to discuss triage options and make triage decisions

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26/288 • The Triage Team will be given information about availability of resources, priority scores, and priority groupings. • The Triage Team will be given a list of each patient’s Priority Group (color code) and note of significant clinical change (for reassessment). Names, MRNs, and comorbidities will not be communicated to the triage team. • Patients’ ages, whether or not they are healthcare workers, and raw SOFA scores will be available to the Triage Team in the event that a tie-breaker is necessary (see below). • The Triage Team will meet (remotely if needed) to discuss the above patients and triage them with a multi-principle approach. • The team will make decisions about withholding, withdrawing, initiating, and continuing ICU level of care for each patient • Once a decision has been made, a member of the Triage Team will notify the team, patient, and patient’s family in consultation with Palliative Care if available and Spiritual Care will be notified • Documentation will be done by the Triage Team

Communication of triage decisions to patients and families Although the authority for triage decisions rests with the triage team, there are several potential strategies to disclose triage decisions to patients and families. Communicating triage decisions to patients and/or their next of kin is a required component of a fair allocation process that provides respect for persons. The triage team should first inform the affected patient’s attending physician about the triage decision. The triage team and attending physician should collaboratively determine the best approach to inform the individual patient and family. Options for who should communicate the decision include: 1) solely the attending physician; 2) solely the triage team; or 3) a collaborative effort between the attending physician and triage team.

The best approach will depend on a variety of case-specific factors, including the dynamics of the individual doctor-patient-family relationship and the preferences of the attending physician. If the attending physician is comfortable with undertaking the disclosure, this approach is useful because the communication regarding triage will bridge naturally to a conveyance of prognosis, which is a responsibility of bedside physicians, and because it may limit the number of clinicians exposed to a circulating pathogen. The third (collaborative) approach is useful because it may lessen moral distress for individual clinicians and may augment trust in the process, but these benefits must be balanced against the risk of greater clinician exposure. Under this approach, the attending physician would first explain the severity of the patient’s condition in an emotionally supportive way, and then a triage team member would explain the implications of those facts in terms of the triage decision. A triage team member would also emphasize that the triage decision was not made by the attending physician but is instead one that arose from the extraordinary emergency circumstances, and reflects a public health decision. Regardless of who communicates the decision, it may useful to explain the medical factors that informed the decision, as well as the factors that were not

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27/288 relevant (e.g., race, ethnicity, gender, disability, perceptions of quality of life, insurance or socioeconomic status, perceptions of social worth, immigration status, among others). If resources permit, palliative care, spiritual care, and social work may also be helpful to provide ongoing emotional support to the patient and family.

Appeals process for individual triage decisions It is possible that patients, families, or clinicians will challenge individual triage decisions. Procedural fairness requires the availability of an appeals mechanism to resolve such disputes. On practical grounds, different appeals mechanisms are needed for the initial decision to allocate a scarce resource among individuals, none of whom are currently using the resource, and the decision whether to withdraw a scarce resource from a patient who is not clearly benefiting from that resource. This is because initial triage decisions for patients awaiting the critical care resource will likely be made in highly time-pressured circumstances. Therefore, an appeal will need to be adjudicated in real time to be operationally feasible. For the initial triage decision, the only permissible appeals are those based on a claim that an error was made by the triage team in the calculation of the priority score or use/non-use of a tiebreaker (as detailed in Section 2). The process of evaluating the appeal should include the triage team verifying the accuracy of the priority score calculation by recalculating it. The treating clinician or triage team should be prepared to explain the calculation to the patient or family on request.

Decisions to withdraw a scarce resource such as mechanical ventilation from a patient who is already receiving it may cause heightened moral concern. Furthermore, such decisions depend on more clinical judgment than initial allocation decisions. Therefore, there should be a more robust process for appealing decisions to withdraw or reallocate critical care beds or services. Elements of this appeals process should include:  The individuals appealing the triage decision should explain to the triage team the grounds for their appeal. Appeals based in an objection to the overall allocation framework should not be granted.  The triage team should explain the grounds for the triage decision that was made.  Appeals based in considerations other than disagreement with the allocation framework should immediately be brought to the Incident Command Center. The ICC is independent of the triage team and of the patient’s care team.  The appeals process must occur quickly enough that the appeals process does not harm patients who are in the queue for scarce critical care resources currently being used by the patient who is the subject of the appeal.  The decision of the Incident Command Center in consultation with the CMO/ACMO or their physician designee experienced with inpatient care will be final.  Decisions made in cases of appeal by the ICC will be communicated to the attending physician for the patients involved.  Periodically, the Ethics Committee should retrospectively evaluate whether the review process is consistent with effective, fair, and timely application of the allocation framework.

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28/288 Section 2: Allocation Process under Crisis Standard of Care The purpose of this section is to describe the allocation framework that should be used to make initial triage decisions for patients who present with illnesses that typically require critical care resources (i.e., illnesses that cannot be managed on a hospital ward in that hospital). The scoring system applies to all patients presenting with critical illness, not merely those with the disease or disorders that have caused the public health emergency. For example, in the setting of a severe pandemic, those patients with respiratory failure from illnesses not caused by the pandemic illness will also be subject to the allocation framework. This process involves two steps, detailed below: 1. Calculating each patient’s priority score based on the multi-principle allocation framework; 2. Determining each day how many priority groups will receive access to critical care interventions.

First responders and bedside clinicians should perform the immediate stabilization of any patient in need of critical care, as they would under normal circumstances. Along with stabilization, temporary ventilatory support may be offered to allow the triage team to assess the patient for critical resource allocation.

Step 1: Calculation of each patient's priority score using the multi-principle allocation framework As outlined in Table 1 below, points are assigned according to the patient’s Sequential Organ Failure Assessment (SOFA) score (see SOFA clinical parameters in Table 2 below), plus the determination that a patient has a severely limited life expectancy even if they survive to hospital discharge. These are then added together to produce a total priority score, which ranges from 1 to 8. Lower scores indicate higher likelihood of benefiting from critical care, and priority will be given to those with lower scores.

SOFA scores may occasionally need to be modified to reflect the acute condition being assessed and not disabled patients’ functional baselines. This is intended to ensure, for example, that a chronically ventilated patient who is stable (i.e. on home settings) or a baseline non-verbal patient not be disadvantaged by the SOFA scoring system.

The assessment of a patient’s limited life expectancy should be based on the most objective medical evidence and individualized clinical judgment, not simply the patient’s age or comorbid diagnoses. Assumptions about post-hospitalization quality of life should not be included in the individualized assessment of patients’ prognoses.

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29/288 Table 1. Multi-principle Strategy to Allocate Critical Care/Ventilators During a Public Health Emergency

Principle Specification Point System*

1 2 3 4 Save lives Prognosis for SOFA score < 6 SOFA score 6- SOFA score 9- SOFA score hospital survival 8 11 ≥12 (SOFA score#) Save life- Prognosis for … Death … Death years near-term survival expected expected (medical within 5 years within 1 year assessment of despite despite near term successful successful prognosis) treatment of treatment of acute illness acute illness

Table 2. Sequential Organ Failure Assessment (SOFA) Scoring System

SOFA Score Variable 0 1 2 3 4 PaO2/FiO2 mm Hg >400 301-400 201-300 101-200 <100 Platelets, x103/µL >150 101-150 51-100 21-50 ≤20 Bilirubin, mg/dL <1.2 1.2-1.9 2.0-5.9 6.0-11.9 >12 (µmol/L) (<20) (20-32) (33-100) (101-203) (>203) Dop 6-15 or Dop >15 or MABP Epi ≤0.1 or Hypotension None Dop <5 Epi > 0.1 or <70mmHg Norepi < Norepi > 0.1 0.1 Glasgow Coma 15 13-14 10-12 6-9 <6 Score Creatinine, mg/dL <1.2 1.2-1.9 2.0-3.4 3.5-4.9 >5 (µmol/L) (<106) (106-168) (169-300) (301-433) (>434 or anuric)

*FIO2=fraction of inspired oxygen; MAP mean arterial pressure; PaO2 partial pressure of oxygen **Hypotension: - MABP=mean arterial blood pressure in mm Hg [diastolic + 1/3(systolic-diastolic)] - Dop=dopamine in micrograms/kg/min - Epi=epinephrine in micrograms/kg/min - Norepi=norepinephrine in micrograms/kg/min

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30/288 Step 2: Assign patients to color-coded priority groups Once a patient’s priority score is calculated using the multi-principle scoring system described in Table 1, each patient should be assigned to a color-coded triage priority group (Table 3). This color-coded assignment of priority groups is designed to allow the Triage Team to create operationally clear priority groups to receive critical care resources, according to their score on the multi-principle allocation framework. For example, individuals in the red group have the best chance to benefit from critical care interventions and should therefore receive priority over all other groups in the face of scarcity. The orange group has intermediate priority and should receive critical care resources if there are available resources after all patients in the red group have been allocated critical care resources. The yellow group has lowest priority and should receive critical care resources if there are available resources after all patients in the red and orange groups have been allocated critical care resources.

Table 3. Assigning Patients to Color-coded Priority Groups

Use Raw Score from Multi-principle Scoring System to Assign Priority Category

Level of Priority and Code Color Priority score from Multi-principle Scoring System

RED Priority score 1-3 Highest priority

ORANGE Priority score 4-5 Intermediate priority (reassess as needed)

YELLOW Priority score 6-8 Lowest priority (reassess as needed)

Step 3: Make daily determination of how many priority groups can receive the scarce resource The triage team will make determinations daily, or more frequently if needed, about which priority groups will have access to critical care services based on the availability of those resources. These determinations should be based on real-time knowledge of the degree of scarcity of the critical care resources, as well as information about the predicted volume of new cases that will be presenting for care over the near-term (several days). For example, if there is clear evidence that there is imminent shortage of critical care resources (i.e., few ventilators available and large numbers of new patients daily), only patients in the highest priority group (Red group) should receive the scarce critical care resource. As scarcity subsides, more priority

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31/288 groups (e.g., first Orange group, then Yellow group) should have access to critical care interventions.

Resolving “ties” in priority scores/categories between patients. In the event that there are ‘ties’ in priority categories between patients and not enough critical care resources for all patients with the lowest scores, the following considerations should be used as tie-breakers: 1. Life-cycle considerations should be used as the first tiebreaker, with priority going to younger patients.

We recommend the following categories: age 12-40, age 41-60; age 61-75; older than age 75. The ethical justification for incorporating the life-cycle principle is that it is a valuable goal to give individuals equal opportunity to pass through the stages of life— childhood, young adulthood, middle age, and old age. The justification for this principle does not rely on considerations of one’s intrinsic worth or social utility. Rather, younger individuals receive priority because they have had the least opportunity to live through life’s stages.

2. Heightened priority should be given to those who are central to the public health response as the second tie-breaker

Individuals who perform tasks that are vital to the public health response, including those whose work directly supports the provision of acute care to others, should be given heightened priority. This category should be broadly construed to include those individuals who play a critical role in the chain of treating patients. However, it would not be appropriate to prioritize front-line physicians and not prioritize other front-line clinicians (e.g., nurses and respiratory therapists) and other key personnel (e.g., maintenance staff that disinfects hospital rooms).

3. Raw Priority Score If there are still ties after applying priority based on consideration of healthcare workers and life-cycle considerations, the raw priority score should be used as a third tiebreaker, with priority going to the patient with the lower score.

4. Random lottery If there are still ties after these three tiebreakers are applied, a lottery (i.e., random allocation) should be used to break the tie.

It is important to reiterate that all patients will be eligible to receive critical care beds and services regardless of their priority score. The availability of critical care resources will determine how many eligible patients will receive critical care.

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32/288 Appropriate clinical care of patients who cannot receive critical care. Patients who are not triaged to receive critical care/ventilation will receive medical care that includes intensive symptom management and psychosocial support. They should be reassessed daily to determine if changes in resource availability or their clinical status warrant provision of critical care services. Where available, specialist palliative care teams will be available for consultation. Where palliative care specialists are not available, the treating clinical teams should provide primary palliative care.

Section 3: Reassessment for ongoing provision of critical care/ventilator support The purpose of this section is to describe the process the Triage Team should use to conduct reassessments on patients who are receiving critical care services, in order to determine whether s/he continues with the treatment.

Ethical goal of reassessments of patients who are receiving critical care services. The ethical justification for such reassessment is that, in a public health emergency when there are not enough critical care resources for all, the goal of maximizing population outcomes would be jeopardized if patients who were determined to be unlikely to survive were allowed indefinite use of scarce critical care services. In addition, periodic reassessments lessen the chance that arbitrary considerations, such as when an individual develops critical illness, unduly affect patients’ access to treatment.

Approach to reassessment All patients who are allocated critical care services (other than those who receive critical care briefly to allow for initial triage by the Triage Team and are subsequently determined to be unable to receive critical care based on priority assignment) will be allowed a therapeutic trial of a duration to be determined by the clinical characteristics of the patient’s disease and the expected trajectory of recovery. To the extent that the public health emergency involves a novel disease, the decision about trial duration for patients with that novel disease will ideally be made as early in the public health emergency as possible, when data become available about the natural history of the disease. The trial duration for such patients should be modified as appropriate if subsequent data emerge which suggest the trial duration should be longer or shorter. Trial duration will also need to be tailored for other non-pandemic diseases and patient contexts, given the concern that patients with certain disabilities may need longer trials to determine benefit. Patients who present for acute care and are already using a ventilator chronically for pre-existing respiratory conditions (e.g., home ventilation or ventilation at a skilled nursing facility) should NOT be separated from their chronic ventilator to reallocate it to other patients.

The triage team will conduct periodic reassessments of patients receiving critical care/ventilation based on information provided by the clinical team. A multidimensional assessment should be used to quantify changes in patients’ conditions, such as recalculation of severity of illness scores, appraisal of new complications, and treating clinicians’ input. Patients showing improvement will continue with critical care/ventilation until the next assessment. If

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33/288 there are patients in the queue for critical care services, then patients who upon reassessment show substantial clinical deterioration as evidenced by worsening SOFA scores or overall clinical judgment should have critical care withdrawn, including discontinuation of mechanical ventilation, after this decision is disclosed to the patient and/or family. Although patients should generally be given the full duration of a trial, if patients experience a precipitous decline (e.g., refractory shock and DIC) or a highly morbid complication (e.g., massive stroke) which portends a very poor prognosis, the triage team may make a decision before the completion of the specified trial length that the patient is no longer eligible for critical care treatment

Rapid reassessment of patients unable to be triaged initially Those patients who receive critical care services (e.g. mechanical ventilation) emergently in order to allow time for initial triage by the triage team, but who are subsequently determined to be unable to receive critical care based on priority assignment, will receive medical care including intensive symptom management and psychosocial support. They will not receive a full trial of critical care as described above. By way of example, this might include patients intubated in the field, patients intubated emergently in the emergency department, patients with severe trauma stabilized in the emergency department and brought to the ICU, and patients resuscitated on a medical floor in a code situation.

Appropriate clinical care of patients who cannot receive critical care. Patients who are no longer eligible for critical care treatment should receive medical care including intensive symptom management and psychosocial support. Where available, specialist palliative care teams will be available for consultation. Where palliative care specialists are not available, the treating clinical teams should provide primary palliative care.

This is a working document and one that will be continually updated as more becomes understood surrounding the public health emergency and the disease severity within our community.

Resources University of Pittsburgh, “Allocation of Scarce Critical Care Resources During a Public Health Emergency Model Policy”: https://ccm.pitt.edu/?q=content/model-hospital-policy-allocating-scarce-critical-care- resources-available-online-now

Tabery J, Mackett CW. Ethics of Triage in the Event of an Influenza Pandemic. Disaster Medicine and Public Health Preparedness. 2008 Jun; 2 (2):114-8.

Christian MD, Hawryluck L, Wax RS, Cook T, Lazar NM, Herridge MS, Muller MP, Gowans DR, Fortier W, Burkle FM. Development of a triage protocol for critical care during an influenza pandemic. Cmaj. 2006 Nov 21;175(11):1377-81.

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34/288 Contra Costa Regional Medical Center, "Crisis Standard of Care Resource Allocation in Conditions of Absolute Scarcity, Principles and Guidelines, Covid-19 Outbreak Policy" New York State Task Force on Life and the Law New York State Department of Health, Ventilator Allocation Guidelines. 2015. Available at: https://www.health.ny.gov/regulations/task_force/reports_publications/docs/ventilator_guide lines.pdf

White DB, Katz MH, Luce JM, and Lo B. Who Should Receive Life Support During a Public Health Emergency? Using ethical principles to improve allocation decisions. Ann Intern Med 2009; 150: 132–8.

University of Washington Medical Center. Material Resource Allocation: Principles and Guidelines, COVID19 Outbreak. 2020. Available at: covid-19.uwmedicine.org

University of Washington Medical Center. Triage Team: Composition and Roles, COVID19 Outbreak. Available at: covid-19.uwmedicine.org

Beauchamp, TL and Childress, JF: Principles of Biomedical Ethics, 5th edition (New York: Oxford University Press, 2001), 264-272.

Levine RJ, Kinlaw K, et al. Ethical Guidelines in Pandemic Influenza. 2006 Sept 21. Available at: http://www.cdc.gov/od/science/phec/.

White DB. Allocation of Scarce Critical Care Resources During a Public Health Emergency. 2020 March 26.

APPROVALS

System Alameda AHS/Highland/John George/San Leandro Department Date: N/A 05/2020 05/2020 Pharmacy and Date: N/A N/A N/A Therapeutics (P&T) Clinical Practice Date: 05/2020 N/A N/A Council (CPC) Medical Executive Date: N/A 05/2020 05/2020 Committee (MEC) Board of Trustees Date: N/A N/A

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TITLE: PAIN ASSESSMENT AND MANAGEMENT

Department Pharmacy Effective Date 09/2012 Campus AHS System Date Revised 06/2014, 03/2015, 06/2019, 08/2020 Category Clinical Next Scheduled 09/2023 Review Document Owner Medical Director, Pain Executive Chief Administrative Med and Functional Responsible Officer/Chief Nurse Executive Clinic Printed copies are for reference only. Please refer to electronic copy for the latest version.

PURPOSE 1. To safely address pain relief in a timely manner.

2. To monitor and evaluate the patient’s response to analgesia.

3. To make adjustments as required for patient comfort.

4. To communicate and educate patients and family in current pain management techniques.

5. To develop a patient care plan tailored to the patient’s individual needs.

POLICY Alameda Health System shall provide patient-centered care by involving the patient in the assessment and management of their pain. All patients have the right to have their pain managed. This is considered a basic right for all patients. Pain is a highly individual experience and the affected person therefore must be considered the expert judge of its intensity. Pain assessments and remedies must be tailored to the individual patient’s age, abilities, personal, cultural, spiritual, and/or ethnic beliefs as well as patient’s diagnosis and safety. This right is communicated in the information given to patients at the time of admission informing them of their rights and responsibilities.

DEFINITIONS: Pain: An unpleasant sensory and emotional experience associated with actual or potential tissue injury or described in terms of that damage as perceived by the patient.

Non-verbal and Pre-verbal: Patients unable to verbally articulate reports of pain like infants, toddlers, confused elderly and cognitively impaired adults

Acute pain: Pain directly related to tissue damage that lasts for less than 12 weeks. Pain of recent onset. Common causes include injury, surgery and infection. It lasts anywhere from a few hours up to a few weeks. Also includes recurrent pain as in migraine.

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Chronic pain: Pain that persists for more than 12 weeks. It is often associated with neurological problems and arthritis.

Cancer pain: Any pain caused by presence of cancer or malignancy. Can be acute or chronic.

Labor pain: The experience of pain during labor is highly variable among women in the sensory and affective dimensions. The severity of labor pain can be influenced by a multitude of factors.

Roles and Responsibilities 1. Leadership – Quarterly meetings of the System Pain and Addiction Committee Meeting will engage in oversight of pain management which supports safe and effective practice and sustainable improvements across the various disciplines and departments involved in pain assessment, pain management, and safe opioid prescribing.

2. The assessment of pain is an interdisciplinary process including physicians, advanced practice providers, nurses, pharmacists, physical therapists and other clinical disciplines involved with the patient’s care. A licensed nurse is responsible for an assessment of pain on admission to the hospital as an inpatient or as an outpatient. The licensed nurse will interact with the physician when it becomes evident that current pain management regimens are ineffective. The interdisciplinary team may present information during the Collaborative Care Rounds for appropriate planning and interventions to meet the patient’s needs regarding pain management. Pain management will be incorporated into the patient’s interdisciplinary plan of care if applicable. The hospital collects data on pain assessment and management including types of interventions and effectiveness.

3. Emergency Department (ED) Patient: The hospital screens patients for pain during emergency department visits and at the time of admission. To meet the needs and improve the overall care of patients recurrently seeking care in the ED for chronic pain needs. Recommendations are made as to what treatments can be provided in the ED. For example, the team may recommend that patients with chronic pain not receive narcotics for their chronic pain; rather, the patient’s primary care physician (PMD) should be involved in creating a pain plan for to safely manage the patient’s pain. The ED does not administer or prescribe additional opioids after the first Emergency Department visit for any complaint, or if you have already received opioids from another provider. Similarly, recommendations for patients with chronic pain needs often involve not using opiates or benzodiazepines except in case of new and acute issues, such as trauma. The ED physician will check a Prescription Monitoring Drug Program linked to the Department of Justice CURES program before prescribing discharge opioid medications with a duration of greater than 7 days.

Staff Responsibilities in Managing Pain 1. Assess the patient’s pain both objectively (vital signs), and subjectively (e.g., burning, shooting, stabbing) and understand that the patient’s self-report of pain is the most accurate.

2. Teach the patient/family about pain and relief, include them in pain management decisions and establish with patients their current comfort/function goals. Include attempting non- pharmacological methods.

Page 2 of 15 37/288 3. Offer pain medications or interventions frequently and/or as ordered.

4. The hospital involves patients in the pain management treatment planning process by: • Developing measurable pain goals • Discussing treatment plan • Providing patient education on pain management • Developing a pain plan of care which includes pain goal • Add pain goal to care board in patient room

5. Request further intervention orders if pain management is ineffective, check using pain scale.

6. Assure that unresolved pain present at discharge or transfer is addressed for continuity of care.

Scope of Assessment/Reassessment 1. Pain is assessed on admission and reassessed every four (4) hours as necessary or when indicated by verbal or non-verbal signs and/or symptoms of pain. Pain is also considered during the provision of interventions provided by ancillary services. All members of the multidisciplinary team have the responsibility to monitor a patient for the presence or absence of pain. When pain is identified, it will be reported to the appropriate provider for further intervention. Pain is also assessed when complete vital signs (Blood pressure, temperature, pulse, and respirations) are taken. Response to pain interventions is reassessed to monitor effectiveness and to determine whether further intervention is needed.

2. Pain will be reassessed within 30-60 minutes after each PRN pain medication and 15 to 30 minutes following PRN IV Push medication administration.

3. The patient is assessed regarding their perception of the effectiveness of, and any side effect to, his or her condition.

4. If the patient indicates verbally or nonverbally they are having pain, an assessment of pain is performed using the age/development appropriate tool. The specific tool will be selected for the patient and used during the duration of the hospitalization unless the patient’s verbal or cognitive skills are altered. Refer to table below.

Patient Type Pain Assessment Tool Adult, Cognitively Intact Modified Wong Baker Faces/0-10 Pain Intensity Scale Non-English Speaking Adult/Child Modified Wong Baker Faces/0-10 Pain Intensity Scale Nonverbal Adult Adult Nonverbal Pain Scale Adult, Advanced Dementia, Verbal Modified Wong Baker Faces/0-10 Pain Intensity Scale Adult, Advanced Dementia, Nonverbal Adult Nonverbal Pain Scale Neonates Neonatal/Infant Pain Scale (NIPS) Neonates (NICU) Neonatal Pain/Agitation/Sedation Scale (N-PASS) Pediatrics Faces, Legs, Activity, Cry, Consolability (FLACC) Pediatrics Ages 3-18 Modified Wong Baker Faces/0-10 Pain Intensity Scale Adult, on pain drip medication in critical care Critical Care Pain Observation Tool (CPOT) unit

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See attachments for details of each pain scale

Attachment A: Modified Wong Baker Faces/0-10 Pain Intensity Scale Attachment B: Adult Nonverbal Pain Scale Attachment C: Neonatal Infant Pain Scale (NIPS) Attachment D: Neonatal Pain, Agitation, & Sedation Scale (N-PASS) Attachment E: Face, Legs, Activity, Cry, Consolability Scale (FLACC) Attachment F: Critical Care Pain Observation Tool (CPOT)

 When able, these factors will be included in the pain assessment:  Intensity (Initial assessment and reassessment)  Quality (Initial assessment and reassessment)  Location(s) (Initial assessment and reassessment) (All pain locations are assessed)  Pain Type (Initial assessment and reassessment) o Nociceptive – Somatic o Nociceptive – Visceral o Neuropathic  Duration (Initial assessment)

5. A patient’s report of pain is assessed on admission to the hospital, at the initial visit, post invasive procedures, and when the patient complains of pain.

6. The frequency of pain reassessment shall be dictated by the intensity of the patient’s pain and the effectiveness of pain relief strategies. However, when pain is present, a pain reassessment is generally performed at least every 4 hours and more often as needed by a licensed healthcare provider. The physician is notified of the patient’s pain when treatment fails to reduce the pain to a level acceptable to the patient or as ordered by the physician. If no pain is present, the licensed healthcare provider will reassess for pain as warranted by patient condition, when the patient complains of pain and post invasive procedure.

7. In the ambulatory clinics, pain is assessed by members of the multidisciplinary team based on the patient’s verbal and non-verbal cues. Pain scales may be used to quantify pain as needed. Routine screening with vitals is not required but may be utilized in specific clinics.

Treatment/Management 1. Pain is managed by pharmacological treatment, non-pharmacological treatment, and interventional procedures. • Pharmacological treatment may include non-opioids, opioids, and adjuvants • In order to minimize opioid usage and enhance analgesic effectiveness, consider adding around- the-clock usage of non-opioid agents such as: o Acetaminophen o Neuropathic agents (e.g. gabapentin, venlafaxine, amitriptyline, pregabalin) o NSAIDs (e.g. ibuprofen, naproxen, ketorolac) o Topical/ local anesthetics (e.g. lidocaine patch) over the site of pain

Page 4 of 15 39/288 • Consider use of regional anesthesia when possible and if appropriate • Pain medication shall be administered utilizing the appropriate dosage as Indicated by the Provider's medication order and the pain scale

2. Non-pharmacological treatment may include physical interventions and cognitive behavioral strategies including but not limited to:  Repositioning of the patient  Breathing/relaxation techniques  Cool, quiet, dark room  Ambulation of the patient  Exercise as allowed by physician and tolerated by patient  Therapeutic massage (i.e., back rub)  Bathing or sitz bath  Diversion techniques (i.e., television or video tape viewing, reading, music therapy, meditation) IPET Relaxation channel  Therapeutic communication  Spiritual counseling  Visitation from family/significant others  Aromatherapy  Ice pack/heating pack  Acupuncture

2. Consider pain control options that are appropriate for the patient, family, diagnosis and setting and formulate a corresponding pain management plan.

3. Administer and monitor pharmacological agents as ordered in the medical plan.

4. Be aware of side effects and drug interactions of various drug therapies that may influence the effect. Institute bowel care to prevent constipation. Monitor patient for signs/symptoms of constipation and notify MD for bowel care.

5. Adjustments in dose and frequency will be based on reassessment of pain relief and the physician’s orders.

6. All patients are considered and monitored as high risk for adverse outcomes from opioids. When possible, multimodal pain management strategies are used. The goal is to reduce exposure to opioids in all patients.

Whenever possible, a. Utilize a multimodal approach with nonopioid agents b. Schedule opioids as needed instead of around the clock c. Use the lowest effective opioid dose for the shortest amount of time d. Assess opioid usage daily and actively work to wean by decreasing dose OR lengthening the time between available doses e. Remove IV opioids as soon as possible

Page 5 of 15 40/288 7. Assess for need for out patient referrals and or recommendations, i.e., acupuncture, adjustment therapy, pain clinics, etc.

Tracking and Monitoring 1. Consider inpatient Pain consult to aid with pain management. Can be requested by a physician or advanced practice provider. a. Refer patients with Opioid Use Disorder (OUD) or at high risk for OUD to Opioid Review Committee. This committee will discuss and manage shared patients in the Buprenorphine Induction Clinic and Ambulatory Pain Clinic. 2. The hospital monitors the use of opioids and reports adverse events to ensure opioids are used safely. 3. Performance improvement data is reviewed quarterly to ensure proper that pain assessment, pain management and safe opioid prescribing recommendations are followed.

Education 1. Patient education may focus on: a. Fears commonly held by patients in pain. b. Indication, potential side effects, and perception of effectiveness of pain medication c. Concepts behind multimodal pain management and non-pharmacological pain treatment modalities d. Physical dependence, drug tolerance, and addiction. e. Explanation of pain intensity scales f. Explanation of treatments g. Resources post discharge h. Safe use, storage, and disposal of opioids when prescribed

2. Staff and licensed independent practitioners are provided with educational resources to improve pain assessment, pain management, and the safe use of opioid medications based on the identified needs of its patient population. 3. Staff and licensed independent practitioners may consult and refer patients with complex pain management needs to the: a. Chronic Pain Consult Service in the inpatient setting b. Buprenorphine Induction Clinic a) Buprenorphine Induction Clinic is a primary care based clinic. They offer rapid, low threshold access to Medication-Assisted Treatment (MAT), case management, and close integration with the inpatient teams, the pain program and primary care providers. c. Bridge Clinic for substance use disorder a) The Bridge Clinic is a multidisciplinary specialty substance use disorder treatment program that integrates buprenorphine treatment with traditional behavioral health counseling. d. Substance Use Navigator (SUN) for patients with substance use disorder a) Substance Use Navigators will work to improve access to treatment for substance use disorder within the context of the California Bridge Program. SUNs are available to any provider in any setting at AHS and can be consulted by several means detailed here: https://www.highlandbridge.org/

Page 6 of 15 41/288 Documentation 1. Indicate the pain rating scale in the medical record that was utilized to determine the pain score at each interval of assessment.

2. When patient condition allows, determine and document the patients pain goal in the electronic health record

3. Document the reassessment of the pain score in the medical record.

4. Document any patient side effects, patient /family education or treatment goal(s) in the medical record as applicable.

Discharge If pain is still present at discharge; pain management will be addressed as part of the discharge instructions.

If prescribing opioids at discharge for opioid naïve patients, limit supply to 5 days when possible.

Prescribers are to check The Controlled substance Utilization Review and Evaluation System (CURES) or the Prescription Drug Monitoring Program before prescribing opioids for a duration of over 7 days.

REFERENCES 1. Cohen, L., Lemanek, K., et al. (2007) Evidence-based Assessment of Pediatric Pain. Journal of Pediatric Psychology, Vol 33 No 9, pp 939-398.

2. Herr, K., Garand, L. (2001) Assessment and Measurement of Pain in Older Adults. Clinical Geriatric Medicine, Vol 17, No 3, pp 457-vi.

3. Jarzyna, D., Pasero, C., et al. (2011) American Society for Pain Management Nursing Guidelines on Monitoring for Opioid-Induced Sedation and Respiratory Depression. Pain Management Nursing, Vol 12, No 3, pp 118-145.

4. The Joint Comission – LD.04.03.13, PC 01.02.07, PC.01.02.01, PI.01. 01.01,

5. Rahu, M., Grap, M. et al. (2015) Validity and Sensitivity of 6 Pain Scales in Critically Ill, Intubated Adults. American Journal of Critical Care, Vol 24, No 6, pp 514-523.

6. Williamson, B., Hoggart, B. (2005) Pain: A Review of Three Commonly Used Pain Rating Scales. Journal of Clinical Nursing, Vol 14, pp 798-804.

Page 7 of 15 42/288 APPROVALS

System Alameda AHS/Highland/John George/San Leandro Department Date: N/A 06/2020 06/2020 Pharmacy and Date: 07/2020 N/A N/A Therapeutics (P&T) Clinical Practice Date: 08/2020 N/A N/A Council (CPC) Medical Executive Date: N/A 08/2020 08/2020 Committee Board of Trustees Date: N/A N/A

Page 8 of 15 43/288 Attachment A

Children and adults with limited verbal skills, adult/geriatrics/adolescents with appropriate cognitive and verbal skills will utilize the Modified Wong and Baker Faces/0-10 Pain Intensity Scale a. Considerations i. Patients are assessed for pain utilizing a modified Wong-Baker Faces Pain Scale superimposed on the 0-10 Pain Intensity Scale. ii. This pain scale will be used for patients with impaired cognition and/or communication through observation of facial characteristics or asking the pediatric patient to describe which face compares with how they feel. iii. This pain scale will be used to assess a patient’s pain level if they display appropriate cognitive and verbal skills. b. Procedure for children and adults with limited verbal skills i. Explain to the patient that each face is for a person who feels happy because he has no pain (hurt) or sad because he has some or a lot of pain.  Face #1 is very happy because he doesn’t hurt at all (Pain Intensity 0)  Face #2 hurts just a little bit (Pain Intensity 2)  Face #3 hurts a little more (Pain Intensity 4)  Face #4 hurts even more (Pain Intensity 6)  Face #5 hurts a whole lot (Pain Intensity 8)  Face #6 hurts as much as you can imagine, although you don’t have to be crying to feel this bad (Pain Intensity 10)  Ask the patient to choose the face that best describes how he or she is feeling.

Key Elements Facial grimacing Writhing Withdrawal of Moaning Tearing limb c. Procedure for adult/geriatrics/adolescents with appropriate cognitive and verbal skills. i. Explain to the patient that the scale ranges from 0=no pain to 5=distressing pain to 10=unbearable pain. Ask the patient to choose the numeric value that best describes how he or she is feeling.  Scale/Tool: . 1-3 Mild Pain . 4-6 Moderate Pain . 7-10 Severe Pain

Page 9 of 15 44/288 Attachment B Adult Non-Verbal Pain Score (ANVPS)

a. Considerations i. > 16 years old ii. Unable to respond to numeric or visual scale iii. Cognitively impaired due to disease process or sedation b. Procedure i. Using the ANVPS scale evaluate the patient on each of the five key elements. c. Key elements i. Facial expressions ii. Activity movement iii. Guarding iv. Physiological/vital signs v. Respiratory d. Scale Tool 0 – 2 = No Pain 3 – 6 = Moderate Pain 7 – 10 = Severe Pain

Page 10 of 15 45/288 Attachment C Neonatal Infant Pain Scale (NIPS)

a. Considerations i. Neonates b. Procedure i. Using the NIPS pain scale, evaluate the patient on each of the six key elements. c. Key elements i. Facial expressions ii. Cry iii. Breathing pattern iv. Arms v. Legs vi. State of arousal d. Scale Tool 0 – 1 = No Pain 2 – 7 = Pain Present

Page 11 of 15 46/288 Attachment D

a. Considerations i. Neonates b. Procedure i. Using the N-PASS pain scale, evaluate the patient on each of the five key elements. c. Key elements i. Cry irritability ii. Behavior state iii. Facial expression iv. Extremities tone v. Vital signs; HR, RR, BP, O2sat d. Scale Tool 0 – 1 = No Pain 2 – 10 = Pain Present

Page 12 of 15 47/288 Attachment E

Face, Legs, Activity, Cry, Consolability Scale (FLACC)

a. Considerations i. Children up to 3 years of age b. Procedure i. Using the FLACC scale, evaluate the patient on each of the five key elements. c. Key elements i. Face ii. Legs iii. Activity iv. Cry v. Consolability d. Scale Tool 1-3 Mild Pain 4-6 Moderate Pain 7-10 Severe Pain

Page 13 of 15 48/288 Attachment F

Critical Care Pain Observation Tool (CPOT)

Indicator Score Description Facial expression 0 Relaxed, neutral no muscle tension observed 1 Tense Presence of frowning, brow lowering, orbit tightening and levator contraction or any other change (e.g. opening eyes or tearing during nociceptive procedures) 2 Grimacing All previous facial movements plus eyelid tightly closed (the patient may present with mouth open or biting the endotracheal tube) Body movements 0 Absence of movements or normal position Does not move at all (doesn’t necessarily mean absence of pain) or normal position (movements not aimed toward the pain site or not made for the purpose of protection) 1 Protection Slow, cautious movements, touching or rubbing the pain site, seeking attention through movements 2 Restlessness/Agitation Pulling tube, attempting to sit up, moving limbs/thrashing, not following commands, striking at staff, trying to climb out of bed Compliance with the 0 Tolerating ventilator or movement ventilator Alarms not activated, easy ventilation (intubated patients) 1 Coughing but tolerating Coughing, alarms may be activated but stop spontaneously 2 Fighting ventilator Asynchrony: blocking ventilation, alarms frequently activated Vocalization (extubated 0 Talking in normal tone or no sound patients) 1 Sighing, moaning 2 Crying out, sobbing Muscle tension 0 Relaxed No resistance to passive movements Evaluation by passive flexion 1 Tense, rigid and extension of upper limbs Resistance to passive movements when patient is at rest or 2 Very tense or rigid evaluation when patient is Strong resistance to passive movements or incapacity to being turned complete them

Page 14 of 15 49/288 a. Considerations i. Adult, on pain drip medication in critical care unit b. Procedure i. Using the CPOT scale evaluate the patient on each of the four key elements. c. Key elements ii. Facial expressions iii. Body movements iv. Muscle tension v. Compliance with ventilator (intubated patient) or Vocalization (extubated patient) d. Scale Tool 0 – 2 = No Pain 3 – 6 = Moderate Pain 7 – 8 = Severe Pain

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AHS RESTRAINTS AND SECLUSION IN ACUTE CARE POLICY AND PROCEDURE

Department Nursing, Behavioral Effective Date 09/2016 Health Campus AHS System Date Revised 05/2016, 05/2019, 04/2020 Category Clinical Next Scheduled 09/2023 Review Document Owner System Director, Executive Chief Administrative Regulatory Affairs Responsible Officer/Chief Nurse Executive Printed copies are for reference only. Please refer to electronic copy for the latest version.

PURPOSE 1. To provide guidance for staff use of restraints and/or seclusion while maintaining patient safety and dignity.

2. To provide guidance for staff so that patients are free from restraints and/or seclusion, of any form, imposed by staff as a means of coercion, discipline, convenience, or retaliation.

PHILOSOPHY Each person’s safety is important for successful treatment. It is the goal of Alameda Health System to reduce the use of restraints and/or seclusion. If a patient’s behavior poses an immediate danger to others or self and all non-physical interventions have failed, brief episodes of restraint or seclusion may be necessary to maintain a safe environment for treatment. Trained staff will make efforts to limit episodes of restraint or seclusion to the least amount of time possible. Every effort is made to preserve the safety and dignity of all staff and patients.

POLICY It is the policy of Alameda Health System to limit the use of restraints and/or seclusion for non- behavioral/and behavioral management to situations where less restrictive interventions have been determined to be ineffective to protect the patient or others from harm. It is also our policy to limit the use of restraints and/or seclusion for behavioral management and only for management of violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others.

GENERAL GUIDELINES Patient and family will be provided restraint and seclusion education information, as applicable. The reason for restraint and/or seclusion use will be explained.

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51/288 Restraint and seclusion are each a temporary measure. The use of restraints and/or seclusion is an exception to care, and will be based on an assessment of individual need. Attempts to discontinue restraints and/or seclusion will be considered with each observation.

Restraint and/or seclusion use initiation will be communicated to the Nurse Manager/Director, House Supervisor, and/or Charge Nurse. (Note: This is not required at John George Psychiatric Hospital.)

A licensed independent practitioner (e.g., M.D., D.O., Clinical Psychologist) or qualified Registered Nurse will conduct restraint/seclusion needs assessment and reassessments to determine the justification for the restraint/seclusion and to select the appropriate restraint. Application, removal and monitoring may be delegated to other clinical staff that has had the appropriate training.

Restraint/seclusion initiation on a patient for staff convenience, to coerce or discipline a patient, or as a method of retaliation is strictly forbidden across Alameda Health System.

DEFINITIONS 1. Physical Restraint is any manual method, physical or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move his arms, legs, body, or head freely. Unless otherwise specified, all uses of the word “restraint” in this document refer to physical restraint.

2. Convenience refers to any action taken by the facility to control a resident’s behavior or manage a resident’s behavior with a lesser amount of effort by the facility and not in the resident’s best interest.

3. Discipline refers to any action taken by the facility for the purpose of punishing or penalizing residents.

4. Seclusion is the involuntary confinement of a patient alone in a room or area from which the patient is physically prevented from leaving. Seclusion may only be used for the management of violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member or others. NOTE: THE SAME POLICIES, PROCEDURES, AND GUIDELINES THAT GOVERN THE USE OF RESTRAINT BELOW ALSO GOVERN THE USE OF SECLUSION. SECLUSION AREA IS AVAILABLE AT JOHN GEORGE PSYCHIATRIC HOSPITAL ONLY.

5. Administrative Law Enforcement Restraints are restraints applied by the law enforcement agency. Administrative law enforcement restrains will be honored, unless care is compromised. Only law enforcement staff can administer or remove these types of restraints. Their use is governed by Federal and State law and regulations. Typically these are handcuffs, manacles, shackles, or other restraint devices. (Note: The use of handcuffs or other restrictive devices applied by law enforcement officials is for custody, detention, and public safety, and is not involved in the provision of patient care. Therefore, the use of

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52/288 restrictive devices applied and monitored by law enforcement officials are not considered restraints for purposes of this document.)

The following devices and methods are not restraints: 1. Adaptive/Protective Devices, such as orthopedically prescribed devices, surgical dressings or bandages, protective helmets, or other methods that involve the physical holding of a patient for the purpose of conducting routine physical examination or tests, or to protect the patient from falling out of bed, or to permit the patient to participate in activities without the risk of physical harm.

2. Side Rails are not restraints when: • used to protect or prevent the patient from falling out of bed, unless all four side rails are raised with the intent to restrain the patient; • used with gurneys to prevent patient from falling off; • used with a patient who is recovering from anesthesia, sedated, experiencing involuntary movements, or on therapeutic beds/mattresses; • used for a patient who on a bed that constantly moves to improve circulation or prevent skin breakdown; or • padded and raised for seizure precautions.

3. Medically Necessary Immobilization for Procedures is the use of any usual and customary device for medical, diagnostic, or surgical procedures. These mechanisms usually include arm boards during intravenous therapy, gurney, or exam table straps or belts, use of body restraints during circumcision or the restriction of movement post-operative/post-anesthetic care patient until they are cognizant.

4. Immobilization Devices in use during post-anesthesia care are considered part of the surgical procedure and are not considered a restraint. This post-anesthesia care can occur in ICU, the PACU, or on a nursing unit.

MEDICARE STANDARDS The Medicare Conditions of Participation have delineated standards for the use of restraints. These standards are not specific to the treatment setting, but to the situation for which the restraint is being used to address. The following are definitions and examples of the two standards.

1. Indications for Restraint of the Non-Violent, Non-Self Destructive Patient Medical restraints are used to ensure the safety of the non-violent or non-self destructive patient. The decision to use a medical restraint is determined by a comprehensive individual patient assessment to identify medical problems that may be causing behavior changes in the patient. For example, fever, hypoxia, UTI, sepsis, hypoglycemia, electrolyte imbalances, drug interactions, drug side effects, and thyroid problems, may cause confusion, agitation, and combative behaviors. Addressing these medical issues may eliminate or minimize the need for the use of restraints. Patients are restrained only when essential and after less restrictive alternative interventions have been considered and deemed ineffective. Patients

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53/288 may be restrained in the following situations: a. To protect patients who attempt to remove therapeutic medical devices such as peripheral intravenous lines, central lines, endotracheal tubes, gastric tubes, catheters, drains, dressings, and other medical devices. b. Patients who, due to an acute or chronic confusional state (such as traumatic brain injury or delirium) are unable to follow and thus continue to remove therapeutic devices. c. Examples: i. A patient with Alzheimer’s disease requires IV therapy but is unable to remember why the IV is in his arm and make numerous attempts to remove it. He cannot be diverted by other means and is restrained to protect the infusion. ii. A confused patient with a fractured hip is attempting to get out of bed and compromising his hip precautions. Other efforts to remind, and distract him have been unsuccessful. He is restrained to preserve the hip precautions.

2. Indications for Restraint of the Violent or Self-Destructive Patient Restraint for a patient with violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member or other, is necessary when an unanticipated outburst of severely aggressive or destructive behavior that poses an imminent danger. For example: a. A patient with Alzheimer’s disease has a catastrophic reaction where he/she becomes so agitated and aggressive that he/she physically attacks a staff member. He cannot be calmed by other methods. He/she is restrained to manage behavior, which is dangerous to him, staff and others. b. An intoxicated patient in the emergency department becomes suddenly aggressive and violent and strikes out at staff as he/she tries to elope from the unit. He will not respond to attempts to reassure and calm him. He/she is restrained to manage behavior, which is dangerous to himself, staff or others.

Note: At John George Psychiatric Hospital, a patient is only restrained if he/she is a danger to self. Patients who are a danger to others are secluded/not restrained.

ALTERNATIVES TO RESTRAINT Alternatives and nonphysical interventions are less restrictive interventions and must be attempted and determined to be ineffective to protect the patient and/or others from harm prior to the application of restraints.

1. Psychological Alternatives a. Provide pain relief/comfort measures b. Schedule position changes c. Assess medications to determine if a medication may be contributing to or may alleviate the underlying problem d. Alter treatment regiments, e.g., saline or heparin lock vs. continuous IV when it is not necessary for hydration

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54/288 e. Promote patient’s normal patterns for eating, sleeping, toilet f. Provide sensory aids (glasses, hearing aids) to prevent misinterpretation of cues in the environment g. Ambulate h. Foods/Fluids offered

2. Environmental Alternatives a. Move the patient closer to the nurse’s station for increased supervision b. Increase lighting to compensate for vision loss, use night lights. c. Decrease extraneous noise to provide a more restful environment

3. Least Restrictive Alternatives a. Bed alarm b. Lap belt c. Abdominal Binder d. Distractions (television, music, movies, games, art work, journaling, etc. e. Companionship (staff or family stay with the patient) f. Low bed g. Toileting h. Massage/Back rub i. Comfortable positioning j. Decreased Stimuli

RESTRAINT PROCEDURE STEP 1: Conduct initial restraint assessment of the patient for whom physical or medication restraints are being considered. Document the clinical assessment, including: a. Specific behavior which is interfering with medical care or posing an imminent danger to patient or others. b. Identification of underlying causes, i.e., hydration, nutrition, bowel and bladder function, abnormal labs, medications, pain, etc., your intervention to correct and patient response to the intervention. c. Which alternatives were attempted and their effectiveness. (Note: The use of restraints for the prevention of falls should not be considered a routine part of a fall prevention program.) The assessment should be conducted by a licensed independent practitioner (e.g., M.D., D.O., Clinical Psychologist) or a qualified Registered Nurse.

STEP 2: Implement a written patient’s plan of care for the use or restraints.

STEP 3: Notify Physician, if not currently aware, and obtain order.

STEP 4: Notify Charge Nurse/Nurse Manager/Director and/or Nurse Supervisor.

STEP 5: Decide which type of restraint is least restrictive for the situation to be effective to ensure the patient’s well-being is maintained, if alternatives have been ineffective.

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55/288 STEP 6: If restraint use is for management of violent or self-destructive behavior that jeopardizes the immediate physical safety of the a patient, a staff member, or others, a face-to- face evaluation of the patient must be conducted by a physician trained in conducting face-to- face evaluation, within one (1) hour of the initiation of the restraint. Document the one (1) hour face-to-face in the medical record, which should include the following: a. The patient’s immediate situation/condition or symptoms that warranted the use of restraints. b. The patient’s reaction/response to the intervention c. Alternatives or other less restrictive interventions attempted (if applicable) d. The patient’s medical and behavioral condition e. The need to continue or terminate the restraint.

GUIDELINES 1. Use of restraint must be in accordance with the order of a licensed independent practitioner (e.g., M.D., D.O., Clinical Psychologist) who is responsible for the care of the patient and approved per hospital policy to order restraint.

2. All orders for restraints must be time-limited. Restraint orders shall never be written as standing orders or PRN (as needed) orders. The order must include the type of restraint to be used, the reason for the restraint, and the length of time the restraint is to be utilized.

3. The order for use of restraint must be for a specified period of time: • For non-violent/non-self-destructive behavior restraint use, the provider must reassess the patient and write a new order daily. • For violent/ self-destructive behavior restraint use, a physician or other authorized licensed independent practitioner primarily responsible for the patient’s ongoing care sees and evaluates the patient before writing a new order for restraint or seclusion use every 24 hours,

4. For non-violent/non-self-destructive behavior restraint use, an RN who is qualified by experience and training is authorized to initiate the use of restraint. After restraint application, the RN IMMEDATELY (within a few minutes) notifies the provider and obtains a restraint order. A physician order for restraint must be obtained and a telephone order must be countersigned by the physician within 24 hours of restraint initiation.

5. Implementation of a time-limited order for restraint does not require application of the intervention for the entire period. If the patient demonstrates reduction in the activity/behavior that led to the restraint, restraint must be discontinued at the earliest possible time, regardless of the length of time identified in the order.

6. If restraints are discontinued prior to the expiration of the original order, (see above) a new order must be obtained prior to reapplying the restraints and all the requirements met to re- start the restraint.

7. All orders must be followed by consultation with the patient’s attending physician, when possible, if the patient’s attending physician does not order the restraint.

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Restraint Orders for Management of Violent or Self-Destructive Behavior 1. In addition to the above standards, if restraint use is for management of violent or self- destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others, a face-to-face evaluation of the patient must be conducted by a licensed independent practitioner (e.g., M.D., D.O., Clinical Psychologist).

2. In an emergency where the patient can reasonably be expected to immediately bring harm upon him/herself or others, an RN who is qualified by experience and training is authorized to initiate the use of restraint. After restraint application, the RN IMMEDATELY (within a few minutes) notifies the provider and obtains a restraint order.

3. Within one (1) hour of restrain application, a face-to-face evaluation of the patient must be conducted by a licensed independent practitioner (e.g., M.D., D.O., Clinical Psychologist) and an order obtained.

Time Limitations for Restraint Orders for Management of Violent or Self-Destructive Behavior 1. The order for use of restraints for management of violent or self-destructive behavior must be limited to: a. Four (4) hours for adults b. Two (2) hours for children 9 – 17 c. One (1) hour for children under 9

2. The original order may specify that an RN may reassess the patient at indicated intervals and request that the physician continue the original order for an additional: a. Four (4) hours for adults b. Two (2) hours for children 9 – 17 c. One (1) hour for children under 9

Application of Restraints 1. To assure that patient rights, dignity, and well-being are protected, select and obtain the least restrictive restraint with the maximum freedom of movement, while ensuring the physical safety of the person and others, and using the least number of restraint points. Ensure that it is the appropriate size consistent with the patient’s stature.

2. Some of the following types of restraining devices available at Alameda Health System include: a. Mittens b. Lap/seat belts c. Full use of Bedrails d. Limb e. Trays with spring release devices (geri-chair) f. Waist Roll Belts g. Freedom Elbow Splints h. Twice as Tough restraints

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57/288 3. Position the patient to maintain correct body alignment, prevent aspiration, and promote comfort.

4. Apply the restraint correctly and allow the maximum freedom of movement possible while maintaining effectiveness. a. Limb: i. Do not impede flow of IV infusion or arterial line ii. Never use restraints proximal to an AV fistula shunt b. Belt: i. Avoid tight application that could interfere with breathing

5. Secure restraints by a quick release method that provides for easy removal in the event of a fire or other emergency.

Note: Restraints designed for bed use should be secured to a moveable portion of the bed frame (e.g., the portion which elevates the head). NEVER tie the restraint to the mattress, side rails, or fixed portion of the bed frame.

Documentation, Monitoring, and Reassessment 1. Document time, type of restraint and name of staff that applied the restraint.

2. Re-assess the patient immediately following application to ensure restraints were properly and safely applied. Assess for injury, physical and psychological status and other needs.

3. Update the patient’s Interdisciplinary Care Plan to include the use of restraints.

4. Monitor patients in restraints for violent or self-destructive behavior every fifteen (15) minutes. Staff monitoring the patient should consider or address the following items every fifteen (15) minutes based on clinical judgment and knowledge of the patient and their individual needs. a. Signs of injury associated with the application of restraint. b. Nutrition/hydration c. Circulation, range of motion in the extremities and position change d. Vital signs e. Hygiene and elimination f. Physical and psychological status and comfort g. Readiness for discontinuation of restraint

Note: Patients in restraint for violent or self destructive behavior must be continually monitored face-to-face by an assigned, trained staff member.

5. Provide the patient as soon as medically reasonable with the rational for restraint and the behavior criteria for its discontinuation. (For example: Patient able to comply with safety requests, patient oriented to environment, and/or cessation of verbal threats).

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58/288 6. Provide patient and family with restraint education information and explain the reason for restraint use and why alternatives are not effective. Reassure them that the restraint will be removed as soon as feasible. Document the patient/family education.

7. Monitor the patient in Non-Behavioral Restraints at least every two (2) hours. a. Assess for release of restraints b. Evaluate the patients physical and mental status, emotional, and physical well- being c. Assess circulation, skin condition d. Provide exercise or range of motion and allow for position changes e. Nutritional, Hydration, Hygiene, and Elimination Needs

8. Document reassessment and restraint release during care measures in the medical record and/or on the appropriate restraint documentation form.

9. Evaluate and document the use of alternatives, less restrictive methods and release of restraint with every observation. Look for changes in behavior or clinical condition which would allow the removal of restraints.

10. If the need for restraint extends beyond 8 hours, a face-to-face reassessment of the patient must occur before writing a new order. The licensed independent practitioner (e.g., M.D., D.O., Clinical Psychologist) must conduct a face-to-face reassessment at least every 8 hours (i.e. at 16 hours and 24 hours). The RN may then reassess and consult with the practitioner at 12 hours and 20 hours, and take a phone order to continue restraints if indicated.

11. Document the date, time, condition of the patient in the medical record when restraints are discontinued.

12. If restraints for violent or self-destructive behavior are discontinued prior to the expiration of the original order, a new order must be obtained as soon as possible, but within one (1) hour of reapplying the restraints, and all the requirements met to re-start the restraints.

13. Update the electronic medical record or restraint log every shift. At John George Psychiatric Hospital this is a “denial of rights log”.

MONITORING REQUIREMENTS DURING SIMULTANEOUS USE OF RESTRAINT AND SECLUSION

In the rare circumstance that simultaneous use of restraint and seclusion is deemed necessary, the patient must be continually monitored face-to-face by an assigned, trained staff member or by trained staff using both video and audio equipment that is in close proximity to the patient for the duration of the restraint and seclusion episode. The assessment, reassessment, and documentation requirements outlined above remain applicable.

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59/288 STAFF TRAINING REQUIREMENTS FOR RESTRAINTS 1. Qualified Staff a. Practitioners authorized to order restraints at a minimum, will have a working knowledge of the hospital policy regarding the use of restraint. b. Staff members applying restraints, monitoring, assessing, and providing care for a patient in restraint, shall be trained and able to demonstrate competency prior to performing these actions.

2. Training and competency evaluation for staff with direct patient contact will occur at orientation, before participating in the use of restraint and on periodic bases thereafter. Training and demonstration will focus on the following: a. Techniques to identify staff and patient behaviors, events, and environmental factors that may trigger circumstances that require restraint; b. The use of non-physical intervention skills; c. Choosing the least restrictive intervention based on an individuated assessment of the patient’s medical or behavioral status or condition. d. The safe application and use of all types of restraints used in the hospital, including training in how to recognize and respond to signs of physical and psychological distress (e.g., positional asphyxia); e. Clinical identification of specific behavioral changes that indicate that restraint is no longer necessary; f. Monitoring the physical and psychological well-being of the patient who are restrained, including but not limited to, respiratory and circulatory status, skin integrity, vital signs, and special requirements specified for 1 hour face-to-face evaluation; g. The use of first aid and current certification in the use of CPR.

Note: Physicians and RNs and those staff under their direct supervision do not require first aid certification.

3. Training will be provided by qualified individuals.

4. Documentation of training and competency will be maintained in the staff personnel record.

REPORTING REQUIREMENTS The patient care unit shall complete and submit an occurrence report to the Risk Department within two (2) hours following knowledge of each death that: 1. Occurs while a patient is in restraint at the hospital (excludes soft wrist restraints).

2. Occurs within 24 hours after the patient has been removed from restraint.

3. Known to the patient care unit, occurred within one week after the restraint where it is reasonable to assume that the use of restraint contributed directly or indirectly to a patient’s death. “Reasonable to assume” includes, but is not limited to, death related to restriction of movement for prolonged periods of time, or death related to chest compression, restriction of breathing or asphyxiation.

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PERFORMANCE IMPROVEMENT MONITORING The goal of Performance Improvement is to identify the underlying causes for restraint use and with this understanding to evaluate and reduce the use. Alameda Health System collects, analyzes, and evaluates aggregate restraint use data on all restrain episodes to define ways to establish a baseline and to reduce the risk associated with restraint use through preventive strategies, alternatives to restraint use and process/care redesign improvements.

Attachments 1. AHS Restraints Decision Tree 2. AHS Restraints Use Algorithm

REFERENCES 1. The Joint Commission: PC.03.05.01- PC .03.05.19

2. California Code of Regulations: 9 CCR § 865.4; 22, CCR §§ 70059, 70577

3. CMS Conditions of Participation: 42 CFR § 482.13 (e) - § 482.13 (g)

APPROVALS

System Alameda AHS/Highland/John George/San Leandro Department Date: N/A 04/2020 04/2020 Pharmacy and Date: N/A N/A N/A Therapeutics (P&T) Clinical Practice Date: 08/2020 N/A N/A Council (CPC) Medical Executive Date: N/A 08/2020 08/2020 Committee Board of Trustees Date: N/A N/A

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61/288 Restraint Use Algorithm A restraint is any manual method, physical or mechanical device, material or equipment that immobilized or reduces the ability of a patient to move his/her arms, legs, body or head freely. A drug is also a restraint when used solely to manage behavior or restrict the patient’s freedom of movement & is not standard treatment or dosage for the patient’s condition.

Is the patient exhibiting behavior that requires restraint?

Yes

Assess & document use of alternative or less restrictive interventions that were attempted Review Appendix C: Examples of Alternative Interventions and Less Restrictive Devices

Non-Violent, Non-Self- Destructive Restraint Use: For patients who are NOT demonstrating

violent, self-destructive behaviors and Were less restrictive alternatives Yes are demonstrating behaviors such as: Continue to Monitor confusion, impulsiveness, agitation; and/or interventions effective? pulling at lines, tubes, and dressings.

(Review AHS Restraint Policy)

Violent / Self Destructive Restraint Use: MD Order / Renewals: No

Restraint order will be obtained and 1. Notify Physician of Patient’s For patients that ARE demonstrating violent, self- renewed by the end of the next Condition destructive behaviors such as: combative, destructive; calendar day after MD assessment hitting, kicking or suicidal. Behaviors may be intensified in 2. Obtain a Restraint Order patients with certain diagnoses, such as: aggressive OR dementia, detoxification; acute delirium and head injury For emergent situations, Perform the comprehensive Face-to-Face restraint Non-Violent, Non-Self- assessment within 1 hr. of initiating restraint. Destructive Restraint Patient 1. RN may initiate restraints, MD Order / Renewals: Monitoring assesses patient’s condition. 2. After patient’s and/or staff’s The RN notifies physician of patient’s condition (SBAR) and Patient Assessment at initiation & safety is ensured, the RN obtains an initial age specific order and renewal order prior Monitoring at least q 2 hrs. and IMMEDATELY (within a few to the previous restraint order expiration, if still indicated. when discontinued: (see below) minutes after restraint is 4 hours patients > 18 years old 2 applied) notifies the hours patients 9-17 years old 1  however, vital signs & other physician/LIP of patient’s hour for children < 9 years old assessments are done per Unit condition & restraint application Standards. (SBAR documentation) ***MD must assess the patient q 24 hrs. determine 3. Obtains a restraint order from if restraints still needed. New order required every provider. 24 hours for violent/ self-destructive restraint use. Assessment and Monitoring components: at initiation of the restraint, at least q 2 hrs. or q 15 min per type of restraint and when discontinue: Violent/Self Destructive Restraint Patient Monitoring: • Level of distress and agitation, mental status, cognitive functioning

• Circulation of all restrained extremities • Visual checks of patient are ongoing • Comfort and care needs (such as) • Vital Signs & assessments per Unit Standards at 1. nutrition, initiation& ongoing, 2. hydration and • Monitoring VS q 15 minutes; VS taken when DC 3. elimination needs restraints (see below) 4. Release of restraint and Range of motion of restrained limbs (q 2 hrs. for62/288 both types of restraint) • Assessment of the readiness for discontinuing the restraint. RESTRAINTS DECISION TREE/ ALGORITHM

Restraint for Non-Violent, Non-Self- Restraint for Violent, Destructive Behavior Self-Destructive Behavior

• Used to ensure the physical safety of the non- • Used to manage violent or destructive behavior that violent, non-destructive patient who is interfering jeopardizes the immediate physical safety of the patient, with necessary medical and/or nursing care staff, or others. (pulling needed lines/tubes) or compromising o Patient presents with severely agitated or paranoid safety (high fall risk), when alternative behavior, threatening to harm self interventions are unsuccessful. o Includes physical devices, physical holds, and o Patient with memory loss/ dementia and medication. has an unsteady gait or impulsive SITUATION e.g. Soft limb holder, behavior. o Medications (Haloperidol & other antipsychotics) o Immobilization to keep confused or o sedated patient from removing Medical devices (e.g., IV, endotracheal tube, NOTE: Emergency application of restraint (i.e. when need for catheter, etc.) or climbing out of bed restraint intervention occurs so quickly that provider order cannot Mittens, elbow extenders, or soft limb be obtained prior to application), RN may initiate restraint use. holder After patient’s and/or staff’s safety is ensured, the RN o Note: indwelling catheters/tubes can IMMEDATELY (within a few minutes after restraint is applied) cause a patient to be agitated. On a daily notifies the physician/LIP and obtains a restraint order from the basis, evaluate for medical necessity and provider. remove when possible OBS FREQUENCY Patient MUST be assessed at least every 2 hours, Patient MUST be under continuous observation and or more frequently as indicated by patient condition or documenting of observation every 15 minutes

type of restraint REQUIRED Patient MUST be assessed at least every 2 hours Patient MUST be assessed every 15 minutes NURSING ASSESSMENT REQUIRED Requires face-to-face and medical assessment within Requires face-to-face and medical assessment within 1 hour of PROVIDER (LIP) 24 hours of restraint application with documentation of restraint application with ongoing documentation ongoing need ASSESSMENT

Updated 04/25/20

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BREACH NOTIFICATION POLICY

Department Internal Audit and Effective Date 05/2013 Compliance Campus AHS System Date Revised 02/2013, 09/2015, 09/2018, 07/2020 Category Administrative Next Scheduled 09/2023 Review Document Owner Privacy and Regulatory Executive Vice President, Internal Counsel Responsible Audit and Compliance Printed copies are for reference only. Please refer to electronic copy for the latest version.

PURPOSE The purpose of this Breach Notification Policy is to provide guidance to Alameda Health System (AHS) workforce members for breach notification when an impermissible or unauthorized access, acquisition, use and/or disclosure of patient protected health information (PHI) occurs. Breach notification will be carried out in compliance with the American Recovery and Reinvestment Act (ARRA)/Health Information Technology for Economic and Clinical Health Act (HITECH) as well as any other federal or state notification law.

POLICY AHS workforce members will maintain the privacy and security of patients’ PHI consistent with AHS’s policies and applicable laws and regulations. AHS’s Compliance Department will notify the affected individual(s) and appropriate regulatory agencies when there is a breach of unsecured PHI unless AHS can demonstrate a low probability that the information has been compromised.

DEFINITION Breach means the acquisition, access, use, or disclosure of PHI in a manner not permitted under HIPAA, which compromises the security or privacy of the PHI. Breach excludes: 1. Any unintentional acquisition, access, or use of PHI by a workforce member or person acting under the authority of a covered entity or business associate if such acquisition, access, or use was made in good faith and within the scope of authority and does not result in further use or disclosure in a manner not permitted under HIPAA.

2. Any inadvertent disclosure by a person who is authorized to access PHI at a covered entity or business associate to another person authorized to access PHI at the same covered entity or business associate, or organized health care arrangement in which the covered entity participates, and the information received as a result of such disclosure is not further used or disclosed in a manner not permitted under HIPAA.

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64/288 3. A disclosure of PHI where a covered entity or business associate has a good faith belief that an unauthorized person to whom the disclosure was made would not reasonably have been able to retain such information.

4. The use or disclosure involves PHI that has been “secured” according to standards published by HHS. This applies to electronic patient information that has been properly encrypted consistent with standards published by HHS.

Discovery of Breach means that a breach shall be treated as discovered as of the first day on which such breach is known to AHS or, by exercising reasonable diligence, would have been known to AHS or any person, other than the person committing the breach, who is a workforce member of AHS.

Protected Health Information (PHI) means individually identifiable health information that is transmitted by electronic media, maintained in electronic media, or transmitted or maintained in any other form or medium.

Unsecured Protected Health Information (Unsecured PHI) is PHI that has not been rendered unusable, unreadable, or indecipherable to unauthorized persons through the use of a technology or methodology specified by the Secretary of HHS in guidance.

Workforce members include employees, contracted staff, students, volunteers, medical staff and any other individual representing or working at AHS.

PROCEDURE 1. Mitigating Potential Breaches. If a workforce member improperly accesses, acquires, uses or discloses PHI and immediate action may cure or mitigate the effects of such uses or disclosures, the workforce member should take such action. For example, if a workforce member improperly accesses or acquires PHI, they should immediately stop, close, and/or return the information. If a workforce member mistakenly discloses PHI to the wrong person, they should immediately request the return of the information and confirm that no further improper disclosures will be made. If the potential breach is significant or requires further action to mitigate its effects, the workforce member should immediately contact their supervisor and the Compliance Department for assistance and direction.

2. Reporting Potential Breaches to the Compliance Department. AHS workforce members shall immediately report any suspected breach of PHI in violation of the HIPAA Rules and AHS’s privacy policies to the Compliance Department.

3. Investigating Potential Breaches. The Compliance Department shall promptly investigate any reported privacy breach or related complaint to determine whether there has been a “breach” of PHI as defined above, and if so, how notice should be given. To determine whether a breach has occurred, the Compliance Department shall consider:

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65/288 a. Whether the alleged breach involved PHI, i.e., individually identifiable information concerning a patient’s health, health care, or payment for health care, including financial or account information. (45 CFR § 164.402) b. Whether the alleged breach violates the HIPAA privacy rule. Disclosures that are incidental to an otherwise permissible use or disclosure (e.g., a patient overhears a physician speaking with another patient, or sees information about another patient on a whiteboard or sign-in sheet) do not violate the privacy rule so long as AHS implemented reasonable safeguards to avoid improper disclosures. (45 CFR § 164.502) c. Whether there is a low probability that the PHI has been compromised considering relevant factors, including at least the following: (1) the nature and extent of the information involved; (2) the unauthorized person who used or received the information; (3) whether the information was actually acquired or viewed; and (4) the extent to which the risk to the information has been mitigated. (45 CFR § 164.402) d. Whether the alleged breach fits within one of the exceptions identified in the Breach definition above. (45 CFR § 164.402) e. The Compliance Department will document the investigation and conclusions, including facts relevant to the risk assessment. (45 CFR §§ 164.414 and 164.530)

4. Notice – In General. If the Compliance Department determines that a breach of unsecured PHI has occurred, the Compliance Department shall notify the individual(s), CDPH, HHS, and the media (if required) consistent with this Policy and the requirements of 45 CFR §§ 164.404- .408 et seq. Any notice provided pursuant to this Policy must be approved and provided by the Compliance Department.

5. Notice to Individuals. I. State: Upon determination that breach notification is required, the Compliance Department shall notify the affected individual(s) or the individual’s representative without unreasonable delay and in no case later than 15 business days after the breach is discovered based on California breach notification law (see Cal. Civ. Code § 1798.29(a)). II. Federal: Upon determination that breach notification is required, the notice shall be made to individual(s) without unreasonable delay and in no case later than 60 calendar days after the discovery of the breach. It is the responsibility of AHS to demonstrate that all notifications were made as required, including evidence demonstrating the necessity of delay. III. Contents of Notification. The notice shall be written in plain language and include to the extent possible: 1) a brief description of what happened (e.g. the date(s) of the breach and its discovery); 2) a description of the types of information affected (e.g., whether the breach involved names, social security numbers, birthdates, addresses, diagnoses, etc.); 3) steps that affected patients should take to protect themselves from potential harm resulting from the breach; 4) a brief description of what AHS is doing to investigate, mitigate, and protect against further harm or breaches; and

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66/288 5) contact procedures for affected persons to ask questions and receive information, which includes a toll-free telephone number, an e-mail address, website, or postal address. (45 CFR § 164.404)

IV. Methods of Notification. The Compliance Department shall notify the individual by first-class mail to the individual’s last known address or, if the individual agrees to electronic notice and such agreement has not been withdrawn, by electronic mail. The notification may be provided in one or more mailings as information is available. If the organization knows that the individual is deceased and has the address of the next of kin or personal representative of the individual, written notification by first-class mail to the next of kin or personal representative shall be carried out. a. Substitute Notice. In the case where there is insufficient or out-of-date contact information (including a phone number, email address, etc.) that precludes direct written or electronic notification, a substitute form of notice reasonably provided to reach the individual shall be provided. A substitute notice need not be provided in the case in which there is insufficient or out-of-date contact information that precludes written notification to the next of kin or personal representative. 1. Fewer than 10 affected individuals. In a case in which there is insufficient or out-of-date contact information for fewer than 10 individuals, then the substitute notice may be provided by an alternative form of written notice, telephone, or other means. 2. 10 or more affected individuals. In the case in which there is insufficient or out-of-date contact information for 10 or more individuals, then the substitute notice shall be in the form of either a conspicuous posting for a period of 90 days on the home page of AHS’s website, or a conspicuous notice in a major print or broadcast media in AHS’s geographic areas where the individuals affected by the breach likely reside. The notice shall include a toll-free number that remains active for at least 90 days where an individual can learn whether his or her PHI may be included in the breach. b. If AHS determines that notification requires urgency because of possible imminent misuse of unsecured PHI, notification may be provided by telephone or other means, as appropriate in addition to the methods noted above.

6. Notification to California Department of Public Health (CDPH). AHS will notify CDPH as soon as possible without unreasonable delay, but in no case later than fifteen (15) business days of the discovery of the reportable breach. The CDPH Breach Incident Report notification will be sent via email to the appropriate CDPH district representative.

7. Notification to the California Attorney General. If the breach affected more than 500 California residents, the Compliance Department shall submit a single sample copy of the notice that excludes any PHI electronically to the Attorney General. The notice shall be submitted online at https://oag.ca.gov/ecrime/databreach/report-a-breach.

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67/288 8. Notification to Department of Health & Human Services (HHS). If the Compliance Department determines that a breach of PHI has occurred, the Compliance Department will also notify HHS of the breach as described below. a. Fewer than 500 Affected Individuals. If the breach involves the PHI of fewer than 500 individuals, the Compliance Department may either 1) report the breach immediately to HHS or 2) maintain a log of the breaches and annually submit the log to HHS annually within 60 days of the end of the calendar year. (45 CFR § 164.408(c)) b. 500 or More Affected Individuals. If the breach involves 500 or more individuals, the Compliance Department will notify HHS of the breach at the same time the Compliance Department notifies the patient or next of kin. (45 CFR § 164.408(b))

9. Notification to Media. In the event the breach affects more than 500 residents of a state, prominent media outlets serving the state and regional area will be notified without unreasonable delay and in no case later than 60 calendar days after the discovery of the breach. The notice shall be provided in the form of a press release.

10. Notification to Alameda Alliance. Suspected HIPAA PHI disclosures or unauthorized use of PHI involving Alameda Alliance patients must be reported to the Alameda Alliance Health Plan within 24 hours of discovery.

11. Notification from Business Associates. If AHS’s business associate discovers a breach of PHI, the business associate shall immediately notify the Compliance Department of the breach. The business associate shall, to the extent possible, identify each individual whose information was breached and provide such other information needed by AHS to comply with this Policy and AHS’s Business Associate Agreement.

12. Delay of Notification Authorized for Law Enforcement Purposes. If a law enforcement official states to AHS that a notification, notice, or posting would impede a criminal investigation or cause damage to national security, AHS shall: a. If the statement is in writing and specifies the time for which a delay is required, delay such notification, notice, or posting of the time period specified by the official; or b. If the statement is made orally, document the statement, including the identity of the official making the statement, and delay the notification, notice, or posting temporarily and no longer than 30 days from the date of the oral statement, unless a written statement as described above is submitted during that time.

13. Workforce Training. AHS will train all workforce members on the policies and procedures with respect to PHI as necessary and appropriate for the workforce members to carry out their job responsibilities. Workforce members shall also be trained as to how to identify and report suspected privacy breaches to the Compliance Department.

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68/288 REFERENCES 1. 45 CFR PARTS 160 and 164

2. HITECH Act Section 13402

3. Cal. Civ. Code § 1798.29(a)

APPROVALS

System Alameda AHS/Highland/John George/San Leandro Department Date: N/A 07/2020 07/2020 Pharmacy and Date: N/A N/A N/A Therapeutics (P&T) Clinical Practice Date: 08/2020 N/A N/A Council (CPC) Medical Executive Date: N/A 08/2020 08/2020 Committee Board of Trustees Date: N/A N/A

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CHARGE CAPTURE AND RECONCILIATION POLICY AND PROCEDURE

Department Revenue Integrity/Charge Effective Date 08/2020 Capture Campus AHS System Date Revised 08/2020 Category Finance Next Scheduled Review 09/2023 Document Owner Associate Vice President, Executive Responsible Chief Financial Revenue Cycle Officer Printed copies are for reference only. Please refer to electronic copy for the latest version.

PURPOSE The purpose of this policy is to provide a standard and consistent system-wide guideline to validate that all charges for procedures, drugs and/or supplies administered, and physician services have been appropriately posted to the correct patient account in the Epic system in a timely manner. This policy outlines expectations for charge capture and charge reconciliation by clinical departments utilizing the tools and reports available.

POLICY Providers are responsible for completing their clinical workflow in Epic to trigger charges. Each department must have a Departmental Revenue Designee to resolve errors in Charge Review Workqueues and run revenue reconciliation reports to confirm all charges for services performed have been captured timely and accurately each day.

PROCEDURE 1. Charge Capture Process a. Charge Capture will be performed by the designated Clinicians (or Manual Charge Entry staff) in each department regardless of the method of charging. In Epic, charges are typically captured automatically based on the Clinicians orders, documentation, and completion steps, which are referred to as charge triggering. b. Charge Capture responsibilities for the department manager includes providing adequate backup coverage to maintain an accurate, consistent, timely, and compliant charge capture process. c. All chargeable services provided to the patient must be entered regardless of the patient’s ability to pay. d. The Departmental Revenue Designee will review the accuracy of the patient encounters’ charge detail information prior to entering charges and resolve any validation checks at the time of charge entry.

All charges must be entered with the appropriate unit volume, attending and rendering (or reading) physician, complete diagnosis codes and charged to the appropriate patient encounter. Charges that are known to Epic to be missing or have inaccurate information

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70/288 will not post to Accounts Receivable and be found in a Charge Review Workqueue to be resolved.

2. Timeliness of Charge Capture a. All charges must be entered within 2 business days. Charges entered later than 5 business days after the date of service will be considered lagged. b. Charge timeliness will be tracked and monitored by management for review and follow up. c. Any revenue centers with charges posted beyond 5 days will be asked to partner with the Clinical Charge Manager’s team to develop a collaborative action plan to assure charges are being posted timely (within 2 days, but no more than 5 days) d. If the issue is not resolved with the action plan developed, the Clinical Charging Manager will escalate to the Departmental Revenue Designee’s departmental leadership.

3. Charge Reconciliation a. Each Department Manager will ensure that a detailed record of patients receiving services is maintained in their department, (clinic schedule, census list, etc.) b. Departmental Revenue Designees are responsible for daily charge reconciliation. This process includes reviewing the department’s charges from the prior day for accuracy using the available reports, including but not limited to: Census/Patient Encounter reports, Revenue & Usage Reports, and other department-specific reports. Specifically, the Departmental Revenue Designee will use the reports to identify patients, accounts, and charges for their revenue center(s), review the clinical documentation and validate that correct charges have been dropped for each encounter. c. If the Departmental Revenue Designee has questions regarding the charges, they should refer to the clinician, then the Department Manager and then the Charge Capture Clinical Manager. d. If an encounter does not have any dropped charges, is missing certain charges or contains incorrect charges, then the Departmental Revenue Designee should determine the cause, resolve the issues and make all necessary corrections. They must then develop a plan of action to prevent future occurrences. e. If a particular clinician and/or charge entry staff member is consistently failing to trigger or manually enter the appropriate charges that are reflected in the clinical documentation, the Departmental Revenue Designee should work with their Departmental Leadership to address this with the clinician, charge entry staff member and create an action plan outlining the issues and steps to resolve. If the Department follows their action plan but is unable to resolve their charge capture and/or reconciliation issues, the Department Leader or Departmental Revenue Designee should reach out to the AHS Revenue Integrity team to assist with further investigation and facilitating resolution in the form of training and/or system changes as appropriate. f. Departmental leadership and the Departmental Revenue Designee within the revenue center will monitor the reconciliation review process utilizing appropriate reports to identify charge entry performance issues, including but not limited to the following Epic standard reports: i. Revenue Guardian Encounter Report – Hospital Billing ii. Revenue Usage Report – Hospital Billing

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71/288 iii. Charge Review Workqueue Monitoring Report – Hospital Billing iv. Open Encounter Dashboard – Professional Billing g. Revenue Integrity leadership will monitor reconciliation review compliance on a regular basis utilizing Epic reporting tools and will follow up with Cost Center Departmental leadership should gaps in monitoring be identified. h. The Departmental Revenue Designee is responsible, in coordination with their department leadership, for creating department/practice area-specific processes to assure that all charge capture is accurate and timely, including resolving charges in assigned Charge Review Workqueues and running revenue reconciliation reports daily.

APPENDIX 1. Policy Terminology a. Charge Capture i. Clinical Documentation - The clinical activities as captured in Epic that include the clinical documentation (Orderables and Performables) ii. Charge Trigger - The completion step of the charge capture activities that ‘sends’ the charge to the billing modules of Epic b. Charge Reconciliation i. Review of revenue reports (e.g., Revenue & Usage) to validate that all services performed for the specified DOS are reflected a Revenue ii. Where variances exist, use clinical reports/tools to identify charge capture steps that were not completed or completed with error c. Charge Review i. Reviewing and resolving charge transactions with errors that are preventing the charge from posting to AR ii. Charge Review Workqueues assigned to the Clinical Departments catch errors (exceptions) related to price/quantity/service date and should be worked down to zero daily d. Lagged Charges vs. “Late Charges” i. Lagged Charges - any charge not posted to AR on the DOS. Many Epic Charges will post to AR if they are accurate as soon as the clinician completes their clinical documentation in Epic. Delays in clinical documentation are typically the cause of charges being lagged. ii. “Late Charges” – in Epic, the system will attempt to generate a claim after “min days” which is 5 days following the discharge date. Any charge posted to the account AFTER the claim has generated is considered “late” and not billed with the original claim.

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APPROVALS

System Alameda AHS/Highland/John George/San Leandro Department Date: N/A 07/2020 07/2020 Pharmacy and Date: N/A N/A N/A Therapeutics (P&T) Clinical Practice Date: 08/2020 N/A N/A Council (CPC) Medical Executive Date: N/A 08/2020 08/2020 Committee Board of Trustees Date: N/A N/A

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CHARITY CARE POLICY

Department Patient Access Services Effective Date 03/2004 Campus AHS System Date Revised 12/2019, 03/2020 Category Finance Next Scheduled 08/2023 Review Document Director, Patient Access Executive Chief Financial Officer Owner Responsible Printed copies are for reference only. Please refer to electronic copy for the latest version.

PURPOSE The purpose of this policy is to define the eligibility criteria for Charity Care services and to provide administrative and accounting guidelines to assist with the identification, classification, and reporting of patient accounts as charity care.

POLICY Alameda Health System will operate in a manner such that no patient shall be denied service due to an individual’s inability to pay. Consistent with this commitment, it is the policy of Alameda Health System (AHS) to provide Charity Care (financial assistance) to qualified low-income uninsured or underinsured patients to whom we provide services in our community. This policy will be administered in a manner consistent with state and federal laws and regulations.

As required by law, AHS shall provide patients with information regarding charity care and other programs during the patient intake process. Patients (and/ or representatives) are expected to cooperate with AHS to determine charity care eligibility and to contribute to the cost of their care based on their ability to pay. It is imperative that the notification of availability, determination, reporting and tracking of charity care are in concert with our mission and our community obligations.

Patients who do not qualify for charity care, but are uninsured, may qualify for the Patient Discount set forth in the current hospital policy separate from this policy.

DEFINITIONS For the purpose of this policy, the terms below are defined as follows:

Patient’s Family [Health and Safety Code §127400(h)]: a) Patients 18 years of age and older – t h e family includes the patient’s spouse, registered domestic partner and dependent children under 21 years of age. b) Patients under 18 years of age – t h e family includes the patient’s parent, caretaker relatives, and other children (under 21 years of age) of the parent or caretaker relative.

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Federal Poverty Level (FPL): FPL means the poverty guidelines updated periodically in the Federal Register by the U.S. Department of Health and Human Services. [H&S §127400(b)]

Self-pay patient: A patient who does not have third-party coverage from a health insurer, health care service plan, Medicare, or Medicaid/Medi-Cal, and whose injury is not a compensable injury for Worker’s Compensation, automobile insurance, or other insurance (third party liability) as determined and documented by hospital. Self-pay patients may include charity care patients. [H&S §127400(f)]

Uninsured patient: An “uninsured patient” is a patient who has no third-party source of payment for any portion of their medical expenses, including but not limited to, commercial or other health insurer, health care service plan, Medicare, or Medicaid/Medi-Cal, or third party liability. For the purpose of this policy an “uninsured patient” may include a “self-pay” patient.

Discount payment: Describes the situation where the hospital has determined that the patient does not qualify for charity care (i.e., free or almost free care), but is eligible for a discount and is expected to pay only a part of the bill.

Patient with high medical cost: Is a person whose family income does not exceed the FPL percent if that individual does not receive a discounted rate from the hospital as a result of his or her third party coverage. [H&S §127400(g)]

Qualified Patient: Means a patient who is both (A) a patient who is a self-pay patient, or a patient with high medical cost, and (B) a patient who has a family income that does not exceed the 350 percent of the FPL. [Health & Safety Code § 127400(c)]

PROCEDURES I. Determining Eligibility A. Governmental Assistance 1. In determining whether each individual qualifies for charity care, other county or governmental assistance programs should also be considered. Many applicants are not aware that they may be eligible for assistance such as Medi-Cal, Health PAC, Victims of Crime, California Children Services or the Affordable Care Act benefit plans.

2. AHS shall assist individuals in determining if they are eligible for any governmental or other assistance.

3. Persons eligible for programs such as Medi-Cal, but whose eligibility status is not established for the period during which the medical services were rendered, may be granted charity care for those services. AHS may make the granting of charity care services contingent upon the patient applying for governmental program assistance. This may be prudent, especially if the particular patient requires ongoing services.

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B. Criteria for Charity Care Eligibility – Uninsured Patients A low-income uninsured patient is eligible for Charity Care consideration based on meeting the family income eligibility criteria as established by Alameda Health System’s application of the Federal Poverty Income Guidelines. Full charity care (no payment) applies to all patients at 200% or less of the FPL. AHS has extended the Charity Care services to patients who have family income that does not exceed the 350 FPL. Full discount (“write off”) is provided for individuals and families with annual incomes at or below 200% of the current FPL. Partial discounts are provided for individuals and families with incomes above 200% of the current FPL and at or below 350% of the current FPL. Partial discounts adjust based on gradation in income levels.1

C. Criteria for Charity Care Eligibility – Insured Patients Eligibility for Insured Patients 1. A patient who is insured but has “high medical costs” and who is at or below 350% of the federal poverty level (FPL) is eligible to apply for charity care.

2. Charity care applies to the portion of the bill that is the patient’s responsibility.

3. AHS will determine the patient’s Allowable Medical Expenses according to the limiting formula.

4. If a patient has been assigned Medi-Cal share of cost, the share of cost amount may be eligible for charity care.

5. Patients whose income exceeds 350% of the FPL may be eligible to receive discounts based on AHS’s Prompt Payment Discount policy.

6. Insured patients with high deductible plans, high medical costs or limited coverage who have exhausted their benefit coverage may qualify for charity care or discount payment according to the criteria set forth in this policy or our prompt pay discount policy.

D. Income and Monetary Assets of Patient In determining eligibility under this policy, AHS may consider income and monetary assets of the patient. For purposes of this determination, monetary assets shall not include retirement or deferred compensation plans. Furthermore, the first ten thousand ($10,000.00) of a patient’s monetary assets shall not be counted in determining eligibility, nor shall fifty percent (50%) of a patient’s monetary assets over the first ten thousand dollars ($10,000.00) be counted in determining eligibility. Assets are considered to be: cash, checking accounts, savings accounts, money market funds, certificates of deposits, real estate property, etc. [H&S §127401-5]

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E. Charity Care Application a. Application 1. A low-income uninsured hospital patient who indicates the financial inability to pay a bill for a medically necessary service shall be evaluated for charity care assistance or any other federal, state, or county program.

2. The AHS standardized application form, shown as the “Charity Budget Form” (see Attachment A), will be used to document each patient’s overall financial situation. This application should be available in the primary language(s) of service area (i.e., English and Spanish).

3. If an uninsured hospital patient does not complete the application form within 30 days of delivery, AHS will notify the patient that the application has not been received and will provide the patient an additional 120 days to complete the application. If the application form is subsequently submitted it will be accepted.

4. The patient must make every reasonable effort to furnish the hospital with documentation of income. The documentation requirements are on the charity budget form.

The patient must attest in writing that the information they are furnishing to the hospital is accurate.

b. Charity Presumptive Eligibility AHS understands that certain patients may be unable to complete a Financial Assistance application, comply with requests for documentation, or are otherwise non-responsive to the application process. As a result, there may be circumstances under which a patient’s qualification for Financial Assistance may be established without completing the formal assistance application and/or providing the necessary and required documents for approval. AHS may utilize other sources of information to make an individual assessment of financial need to determine whether the patient is eligible for financial assistance and approval. This information will enable AHS to make an informed decision on the financial need of non-responsive patients utilizing the best estimates available in the absence of information provided directly by the patient. In particular, presumptive eligibility for Financial Assistance may be determined on the basis of individual life circumstances that may include: • Homelessness or receipt of care from a homeless clinic; • Participation in Women, Infants and Children (WIC) programs; • Eligibility for food stamps; • Eligibility for school lunch programs; • Living in low-income or subsidized housing; and • Patient is deceased with no estate.

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c. Homeless Patients: Emergency room patients without a payment source may be classified as charity if they do not have a job, mailing address, residence, including temporary residence, or insurance. However, all other county, state, or government programs must be considered as part of enrollment screening. Consideration must also be given to classifying emergency-room-only patients who do not provide adequate information as to their financial status. In many instances, these patients are homeless and have few resources to cover the cost of their care.

For homeless patients seen in our inpatient or emergency services areas, AHS must ensure financial screening is provided to the patient prior to discharge. This includes but is not limited to screening for charity care. d. Special Circumstances 1. Deceased patients without an estate or third party coverage may be eligible for charity.

2. Patients who are in bankruptcy (filed but an open case) or completed bankruptcy in the past three (3) months may be eligible for charity. e. Time Requirement for Determination of Eligibility 1. While it is desirable to determine the amount of charity care for which a patient is eligible as close to the time of service as possible, in some cases, eligibility is readily apparent and a determination can be made before, on, or soon after the date of service. In other cases, it can take investigation to determine eligibility, particularly when the patient has limited ability or willingness to provide needed information. At any time, if a patient sends confirming information and the application that demonstrate qualification for charity care, then charity care will be indicated. AHS will make every effort to provide a determination of eligibility within 30 days of receiving all requested information and documentation from the patient.

2. Every effort should be made to determine a patient’s eligibility for charity care. In some cases, a patient eligible for charity care may not have been identified prior to initiating external collection action. Accordingly, any collection agency will be made aware of the policy on charity care. This will allow the agency to refer patient accounts back to AHS that may be eligible for Charity Care.

3. After 150 days of no response from a patient to formally determine eligibility the account may proceed to debt collection. If the patient was initially identified as probable charity care and the staff has no public or private record to locate the patient (e.g., homeless with no residence) the case may be classified as charity care. The Director of Patient Financial Services will use appropriate judgment to differentiate charity care based on the criteria in lieu of a bad debt determination. a. Denials and Appeals

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Application Denied No financial assistance is granted under this policy. However, if patient is self-pay, the patient may be eligible according to the prompt pay discount policy.

Appeals In the event of a dispute over the application of this policy, a patient may seek review from AHS Director of Patient Access Services or Director of Patient Financial Services. The patient may also follow the hospital’s complaint policy. The patient will be informed of any decision in writing

4. Contracting with Other Organizations to Determine Eligibility AHS may from time to time contract with other organizations that specialize in assisting patients and their families with qualifying for charity or other sources of funding or insurance enrollment. Organizations (Contractors) are required to abide by the policies set forth by AHS. Patients are given information regarding the availability of assistance from these other organizations and are encouraged to cooperate with the qualifying process. Patients are not expected to incur any costs when utilizing the services of these other organizations.

5. Eligibility Period: The eligibility period is up to six months from the date of the initial eligibility determination, unless over the course of that period the patient’s Family Income or insurance status changes to such an extent that the patient becomes ineligible. This discount may be applied retroactively for up to six months if there were unavoidable delays in determining eligibility.

II. Limiting Expected Reimbursement A. General Rule The maximum payment amount for patients who qualify for charity care or a discounted payment, who do not have insurance coverage, shall be the full in effect allowable Medicare rate fee schedule for the service (s) as calculated in accordance with Medicare payment rules. [H&S §127405(d)]

For any patient who has coverage under a third party insurance plan, that third party insurance contract shall establish the payment rate. If the insured patient qualifies for charity care then the patient’s portion of the payment (Copayment) shall be waived.

Please note that “[n]o health care service plan, insurer, or any other person shall reduce the amount it would otherwise reimburse a claim for hospital services because a hospital has waived, or will waive, collection of all or a portion of a patient’s bill for hospital services in accordance with the hospital’s charity care or discount payment policy, notwithstanding any contractual provision.” [H&S § 127444]

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B. Medi-Cal Denied Patient Days and Non-Covered Services Medi-Cal/CCS and other State of California programs patients are eligible for Charity care write-offs related to denied stays in limited circumstances (e.g., when the admission/services were medically necessary as determined by the treating physician or the patient was not safe to discharge and there is no administrative day payment). The Treatment Authorization Request (TAR) will record the reason for the denial. An example where the write-off is charity is when a Medi-Cal pending application results in a denial as not eligible as a result of not meeting program guidelines. Denials for other reasons such as a physician’s failure to write a discharge order cannot be written off as charity care. Recognizing that the hospital is compensated by Medi-Cal on a per case basis, there will be limited circumstances where a charity care write-off will apply.

III. Limited Debt Collections Activities A. Notice Prior to Commencing Collection Activities The hospital or any assignee of a hospital debt, including a collection agency must provide the patient with a clear and conspicuous notice that includes the required language from the various practice acts and a statement that nonprofit credit counseling services may be available in the area.

B. Collection Practices The hospital and the patient may negotiate the terms of the payment plan. The hospital will not charge interest on the extended payment plan debt. An extended payment plan may be re-negotiated with the patient if the patient fails to make all consecutive payments during a 90-day period. Prior to declaring an extended payment plan irremediable the patient must be:

a. Contacted or attempted to be contacted by telephone (last known number); b. Given notice in writing that the plan may be irremediable (last known address); and c. Informed that there is an opportunity to re-negotiate the payment plan.

C. Advancing Debt and Credit Reporting

Until the payment plan is declared irremediable, no report may be made to a consumer credit reporting agency and no civil action may commence. Any advancing of debt for collection or reporting requires the approval of the Director of Patient Financial Services. Advancing of debt collection and/or Credit reporting shall not occur until after 150 days from the date the payment plan is declared irremediable.

D. Collection Agency If a collection agency identifies a patient meeting AHS charity care eligibility criteria, the patient account may be considered charity care, even if they were originally classified for collection or as a bad debt. Collection agency patient accounts meeting charity care criteria should be returned to the AHS billing office and reviewed for charity care eligibility.

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IV. Charity Care Information- Notice A. Patient Intake Process Except in the case of emergency services, Alameda Health System shall provide patients with information regarding charity care, during the patient intake process, if requested. AHS shall also provide patients with contact information for an AHS employee or office from which the patient may obtain further information about charity care and discount payments. The information provided shall be in the primary language of AHS service area and in a manner consistent with all applicable federal and state laws and regulations. A language is a primary language of Alameda Health System service area if 5% or more of Alameda Health System local population speaks the language.

B. Public Notice and Posting of Charity Care Public notice of the availability of assistance through this policy should be made through each of the following means: Posting notices in a visible manner in locations where there is a high volume of inpatient or outpatient admitting/registration. Notices must be posted in at least the emergency departments, billing offices, admitting offices, and hospital outpatient service settings. Posted notices shall contain the following information: 1. A statement indicating that AHS has a financial assistance policy for low-income uninsured patients who may not be able to pay their bill and that this policy provides for full or partial charity care. 2. Identification of a hospital contact phone number that the patient can call to obtain more information about the policy and how to apply for assistance.

C. Bills and Statements AHS shall include charity care information on bills and statements sent to patients. The information shall include following: 1. If the patient meets certain income requirements the patient may be eligible for a government–sponsored program or qualify for charity care or discount payment from AHS. The income requirements shall be stated on the notice. 2. A hospital phone number that patients may call for further information.

3. Posting notice of the availability of assistance and a contact phone number on AHS web site.

4. Providing uninsured patients a document outlining the types of financial assistance available.

D. Emergency Physicians Billing Notice (applicable at Alameda Hospital and San Leandro Hospital)* AHS shall include a notice with the contact information for independent Emergency Physicians that practice at Alameda Hospital and San Leandro Hospital. These independent physician groups have their own discount policies with eligibility criteria which may differ from AHS policies. Emergency physicians are not required to offer an extended payment plan; but if they do, the plan must be interest free. AHS includes in the notice the name of the physician group, the web site, and a contact phone number the patient may call for additional information. Emergency Physicians are the

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Emergency Physician specialists staffing the emergency department of the hospital. Emergency Physicians are not other specialists who consult in the emergency department by request of the Emergency Physician. [H&S §127450-127462]

V. Reimbursing Overcharges If the hospital erroneously collected the patient portion, from a patient who qualifies for charity care, the patient will be reimbursed the principle. This clause shall not apply if the overpayment is $5 or less. In this case, the hospital shall furnish credit equal to the amount of $5 or under for a period of 60 days.

VI. Not Available for Charity Care Charity care and/or discounts provided by this policy are not available for cosmetic procedures. The application of this policy does not apply to any portion of a patient’s services because of the transfer of a patient to another facility that bill for services under a different Tax Identification Number. The hospital will make every effort to locate a charitable organization that AHS is aware of or has a relationship with to furnish elective procedures.

VII. Authority and Responsibilities A. Authority Authority for decision making with regard to this policy and the progression to formal debt collection is granted to the Director for Patient Accounting and Patient Access Services and/or an individual with such authority at a higher level or rank in the hospital including the Vice President of Revenue Cycle, the Chief Financial Officer and other personnel granted this authority for coverage when the Director or designee is not available.

B. Responsibilities Who Can Grant Charity Care Write-offs: Director of Patient Financial Services, Director of Patient Access Services or their designee

C. Roles and Responsibilities: Procedures must be adopted that clearly address the various responsibilities in the determination of charity care. This includes documentation of any contact with the patient, provision of information, and assistance to the patient making the determination of charity care eligibility, and notifying the patient.

D. Record keeping: Records relating to potential charity care patients must be readily accessible. AHS must maintain information regarding the number of uninsured patients who have received service, the number of financial assistance applications completed, the number approved, the estimated dollar value of the benefits provided, the number denied, and the reasons for denial.

In addition, notes relating to charity application and approval or denial should be entered on the patient’s account

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VIII. Submission to OSHPD Beginning January 1, 2008, and biennially thereafter (every two years) by January 1, AHS shall forward copies of this policy to the Office of Statewide Health Planning and Development (OSHPD). Submission of the policy shall be consistent with the manner prescribed by OSHPD.

Who Can Grant Charity Care Write-offs: Director of Patient Financial Services, Director of Patient Access Services or their designee

Accounting for Charity Care: To allow AHS to track and monitor the amount and type of charity care being granted, the hospital will account for the charity care write-offs and record all transactions as an “administrative write-off.”

Roles and Responsibilities: Procedures must be adopted that clearly address the various responsibilities in the determination of charity care. This includes documentation of any contact with the patient, provision of information, and assistance to the patient making the determination of charity care eligibility, and notifying the patient.

Record keeping: Records relating to potential charity care patients must be readily accessible. AHS must maintain information regarding the number of uninsured patients who have received service, the number of financial assistance applications completed, the number approved, the estimated dollar value of the benefits provided, the number denied, and the reasons for denial.

In addition, notes relating to charity application and approval or denial should be entered on the patient’s account.

Submission to OSHPD: Beginning January 1, 2008, and biennially thereafter (every two years) by January 1, AHS shall forward copies of this policy to the Office of Statewide Health Planning and Development (OSHPD). Submission of the policy shall be consistent with the manner prescribed by OSHPD.

ATTACHMENTS  Attachment A: Charity Care Application  Attachment B: Notification Status

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APPROVALS

System Alameda AHS/Highland/John George/San Leandro Department Date: N/A 03/2020 03/2020 Pharmacy and Date: N/A N/A N/A Therapeutics (P&T) Clinical Practice Date: 04/2020 N/A N/A Council (CPC) Medical Executive Date: N/A 04/2020 04/2020 Committee Board of Trustees Date: N/A N/A

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Department Graduate Medical Education Effective Date 06/2020 Campus AHS System Date Revised 06/2020 Category Clinical Next Scheduled 08/2023 Review Document Director, Graduate Medical Executive Chief Medical Officer; Associate Owner Education Responsible Chief Medical Officer Printed copies are for reference only. Please refer to electronic copy for the latest version.

PURPOSE Providing residents with a sound academic and clinical education must be carefully planned and balanced with concerns for patient safety and resident well-being. Each training program must have a program-specific policy addressing clinical and educational work hours and a work hour tracking system that are in compliance with both ACGME requirements and Alameda Health System GME policies. It is the responsibility of the house staff to ensure that they are in compliance with their program’s policy and will be disciplined if they fail to do so. Accurate reporting is considered part of the ACGME “professionalism” competency.

POLICY Clinical Experience and Educational Work Hours: All clinical and academic activities related to the residency program, i.e., patient care (both inpatient and outpatient), administrative duties related to patient care, the provision for transfer of patient care, time spent in-house during call activities and scheduled academic activities such as conferences. Work hours do not include reading and preparation time spent away from the work site.

DEFINITION 1. House Staff/Officer: An Intern or Resident in a training program.

2. Moonlighting: Voluntary, compensated and medically-related work performed inside/outside the institution where the resident is in training or at any of its related participating sites.

3. New Innovation: work hour tracking system in compliance with ACGME requirements and AHS’s policies.

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85/288 PROCEDURE 1. Clinical and educational work hours must be limited to no more than 80 hours per week, averaged over a four-week period, inclusive of all in-house clinical and educational activities, clinical work done from home and all moonlighting.

2. House staff should have eight hours off between scheduled clinical work and education periods; there may be circumstances when residents choose to stay to care for their patients or return to the hospital with fewer than eight hours free of clinical experience and education. This must occur within the context of the 80- hour and the one-day-off- in-seven requirements.

3. House staff must have at least 14 hours free of clinical and educational work after 24 hours of in-house call.

4. House staff must be scheduled for a minimum of one day in seven free of clinical work and required education (when averaged over four weeks). At-home call cannot be assigned on these free days.

5. Clinical and educational work periods for resident must not exceed 24 hours of continuous scheduled clinical assignments. Up to four hours of additional time may be used for activities related to patient safety, such as providing effective transitions of care and/or resident education.

6. In rare circumstances, after handing off all other responsibilities, a house staff may elect to remain or return to the clinical site in the following circumstances: a. To continue to provide care to a single severely ill or unstable patient b. Humanistic attention to the needs of a patient or family c. To attend unique educational events These additional hours of care or education will be counted toward the 80-hour weekly limit.

7. Night float must occur within the context of the 80-hour and one-day-off-in-seven requirements. The maximum number of consecutive weeks of night float, and the maximum number of months of night float per year may be further specified by each ACGME Review Committee.

8. House staff must be scheduled for in-house call no more frequently than every third night (when averaged over a four-week period).

9. Time spent on patient care activities by house staff on at-home call must count toward the 80-hour maximum weekly limit. The frequency of at-home call is not subject to the every-third-night limitation, but must satisfy the requirement for one-day-in-seven free of clinical work and education when averaged over four weeks. At-home call must not be as frequent or taxing as to preclude rest or reasonable personal time for each house staff.

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86/288 10. House staff are permitted to return to the hospital while on at-home call to provide direct care for new or established patients. These hours of inpatient patient care must be included in the 80-hour maximum weekly limit.

11. Moonlighting must not interfere with the ability of the house staff to achieve the goals and objectives of the educational program, and must not interfere with the resident’s fitness for work nor compromise patient safety.

12. Time spent by residents in internal and external moonlighting must be counted toward the 80-hour maximum weekly limit.

13. PGY-1 residents are not permitted to moonlight.

A Review Committee may grant rotation-specific exceptions for up to 10 percent or a maximum of 88 clinical and education work hours to individual programs based on a sound educational rationale.

REFERENCES Common Program Requirements. (2019). Retrieved from ACGME.org: https://acgme.org/What-We-Do/Accreditation/Common-Program-Requirements

APPROVALS

System Alameda AHS/Highland/John George/San Leandro Department Date: N/A 06/2020 06/2020 Pharmacy and Date: N/A N/A N/A Therapeutics (P&T) Clinical Practice Date: 06/2020 N/A N/A Council (CPC) Medical Executive Date: N/A 07/2020 07/2020 Committee (MEC) Board of Trustees Date: N/A N/A

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DISASTER PREPAREDNESS COMMUNICATION

Department Environmental Health and Effective Date 12/2007 Safety Campus AHS System Date Revised 12/2008, 12/2011, 06/2020 Category Administrative Next Scheduled 08/2023 Review Document Director, Environmental Executive Responsible Chief Quality Officer Owner Health and Safety Printed copies are for reference only. Please refer to electronic copy for the latest version.

POLICY The Alameda Health System (AHS) utilizes many different forms of communication devices during normal business operations and mass casualty situations. AHS will use redundant communication during a disaster to ensure a disaster to ensure appropriate stakeholders are kept informed. These forms of communication provide redundancy. We have categorized AHS communications in three groups: primary, secondary, and third level communications. 1. Primary Level communication devices consist of the hospital PBX (primary branch exchange), two-way radios, overhead paging and electronic paging devices. The following are considerations for each: a. PBX (private branch exchange) – Each facility is equipped with its own PBX system. They are all integrated together for enterprise calling. However, they can act independently if required. All systems are powered on the facilities emergency power system and have limited battery backup. If service provider connection is lost, these systems can still operate for internal communications. b. Two-way radios – The two –way radios are used to communicate within department and between personnel as well as to dispatch a location. This system is un-secure communication and should be used only to pass coordinating information. c. Overhead paging – The hospital has the ability to pass overhead general coordinating information to the staff. There is limited capability in providing this to other facilities, but each facility has their own access for this function. d. Electronic paging devices – These devices have the ability to pass information as a direct contact or general announcement. With alphanumeric technology, the text messages can be sent and provide key information to the staff. This system is only functional if the service provider is active.

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88/288 2. Secondary Level communication devices consist of the hospital computer systems, cellular telephones, and message boards. The following are considerations for each: a. Computer systems – These systems are a good form of notification but may have a time delay for updates. During an activation, staff may be unable to maintain a station at a computer. Information from the command center should be shared by leaders with staff. Department Status reports and Resource Requests can be provided to the command center via hard copy. b. Cellular Telephones – These devices are a good form of person to person communication with some group capabilities. This form of communication is only effective as the infrastructure and traffic in the area will allow. In addition, this system can only be used if the service provider is in an active condition. c. Message Board – Message boards (staff use only) are located throughout all facilities. This form of communication can be used for posting disaster communications. Message boards can assist in providing routine updates regarding disaster strategies, tactics and safety notices. All notices must be prominently displayed with the date and time written on the document.

3. Third Level communication include any of the above listed communication devices in its limited capacity plus messengers. a. Messengers – Messengers can be used to transfer information from one person or area to another. This method is time consuming and the information is often time late. Handheld announcing systems can be used, but can cause distractions in high tense areas and are not always clear.

APPROVALS

System Alameda AHS/Highland/John George/San Leandro Department Date: N/A 06/2020 06/2020 Pharmacy and Date: N/A N/A N/A Therapeutics (P&T) Clinical Practice Date: 06/2020 N/A N/A Council (CPC) Medical Executive Date: N/A 07/2020 07/2020 Committee (MEC) Board of Trustees Date: N/A N/A

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DO NOT USE LIST ABBREVIATIONS

Department Multidisciplinary Clinical Effective Date 11/2017 Campus AHS System Date Revised 01/2017, 08/2020 Category Pharmacy, Nursing, Next Scheduled Review 09/2023 Medical Staff Document Owner System Director, Executive Responsible Chief Administrative Pharmacy; Medical Staff; Officer/Chief Nurse Medication Safety Officer Executive; Medical Directors Printed copies are for reference only. Please refer to electronic copy for the latest version.

PURPOSE To promote patient safety by decreasing the potential for errors associated with the use of abbreviations.

POLICY Abbreviations on The Joint Commission’s minimum list of “Do Not Use” abbreviations must not be used anywhere. This applies to all orders and all medication-related documentation that is handwritten (including free text computer entry) or on pre-printed forms. Orders with unapproved abbreviations are not to be accepted, and the prescriber will be contacted to revise/correct the order.

Abbreviation/ Prone to Error Misinterpretation Recommendation Dose Expression Read as a zero (0) or a four (4), Heparin 5000 u causing a 10 fold overdose or Write out “units” U or u Insulin 10 u greater (4u seen as 40 or 4u seen Do not abbreviate “u” as 44) For International Mistaken as IV (intravenous) or IU Write “International unit” unit 10 (ten) Q.D and Q.O.D. Latin Mistaken for each other. The Write “daily” and “every other abbreviation for period after the Q can be mistaken day” once daily & for an I and the O can be an I every other day Zero after decimal Ativan 1.0mg Misread as 10 mg if the decimal Do not place a decimal followed point (1.0) point is not seen by a zero to the right of a whole number. **Exception: A “trailing zero “may be used only where required to demonstrate the level of precision of the value being reported, such as for laboratory

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90/288 Abbreviation/ Prone to Error Misinterpretation Recommendation Dose Expression results, imaging studies that report size of lesions or catheter/tube sizes. It may not be used in medication orders or other medication-related documentation. No Zero before Ativan .5mg Misread as 5mg Always place a zero followed by decimal dose a decimal to left of a fraction (.5mg) MS, MSO4 or Confused for Can mean morphine sulfate or Write “morphine”or MgSO4 one another magnesium sulfate “magnesium”

REFERENCES TJC IM 02.02.01

APPROVALS

System Alameda AHS/Highland/John George/San Leandro Department Date: N/A 07/2020 07/2020 Pharmacy and Date: 08/2020 N/A N/A Therapeutics (P&T) Clinical Practice Date: 08/2020 N/A N/A Council (CPC) Medical Executive Date: N/A 08/2020 08/2020 Committee Board of Trustees Date: N/A N/A

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DONATIONS POLICY

Department All Effective Date 10/2019 Campus AHS System Date Revised 06/2019, 04/2020 Category Administrative Next Scheduled 08/2023 Review Document Chief Administrative Executive Chief Administrative Officer/ Owner Officer/ Chief Nurse Responsible Chief Nurse Executive Executive Printed copies are for reference only. Please refer to electronic copy for the latest version.

PURPOSE To assure donations are accounted for properly.

POLICY It is the policy of the Alameda Health System (AHS) that all donations shall be accounted through the Alameda Health System Foundation (AHSF).

PROCEDURE Donated Supplies or Equipment 1. Donated items must be unopened and in original packaging. All donated items will be checked for quality control. 2. Small qualities of donated items will be accepted by Fairmont Central Supply Service from Monday-Friday between 8:00am-4:00pm. 3. Large quantities of donated items will be coordinated by AHSF or a designated representative for AHS. 4. All donors may receive a donation receipt by emailing AHSF at [email protected]. 5. Donated items will be routed to the appropriate AHS department.

CASH DONATIONS 1. Donations will be distributed to AHS’s areas of greatest need. 2. Donations may be made online directly to AHSF via their website, www.foundationahs.org. 3. Donations may be mailed to the following address: Alameda Health System Foundation, 350 Frank H. Ogawa Plaza, Suite 900, Oakland, CA 94612.

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92/288 APPROVALS

System Alameda AHS/Highland/John George/San Leandro Department Date: N/A 04/2020 04/2020 Pharmacy and Date: N/A N/A N/A Therapeutics (P&T) Clinical Practice Date: 08/2020 N/A N/A Council (CPC) Medical Executive Date: N/A 08/2020 08/2020 Committee (MEC) Board of Trustees Date: N/A N/A

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EMERGENCY OPERATIONS MANAGEMENT PLAN

Department Disaster Command Center Effective Date 08/2011 Campus AHS System Date Revised 04/2014, 06/2017, 02/2020 Category Clinical Next Scheduled 08/2023 Review Document Owner Director, Environmental Executive Chief Quality Officer Health and Safety Responsible Printed copies are for reference only. Please refer to electronic copy for the latest version.

PURPOSE 1. The purpose of the Emergency Operations Management Plan (EOP) is to describe the coordinate response and recovery to the wide range of natural and man-made events that may disrupt normal operations and require a pre-planned response to internal and external emergencies and disasters. The EOP highlights the basic strategies and mechanisms Alameda Health System (AHS) will use to mobilize resources and conduct activities to support emergencies and disasters.

2. The intention of the emergency management program is: a. To protect life, property, and the environment; b. To provide maximum safety and protection from injury for patients, visitors, and staff; c. To attend promptly and efficiently to all individuals requiring medical attention in an emergency situation; d. To provide a chain of command to enable maximum use of resources; e. To maintain and restore essential services as quickly as possible following an emergency incident or disaster; f. To satisfy all applicable regulatory and accreditation requirements.

SCOPE 1. The EOP applies to the continuation of patient care operations and support functions during a hospital or community-wide incident. The plan was developed as an “all- hazard” approach to be adaptable to respond to a variety of emergencies that might occur. This EOP consists of procedures and other reference data, as well as the Annexes, which address high risk hazards identified by the Hazard Vulnerability Analysis (HVA). The EOP is a living plan and will be revised as needed to reflect federal, state, or local changes in policies, procedures or regulatory requirements.

2. This EOP describes the process for coordinating six critical areas and also addresses volunteers involved in disasters and includes: a. CommunicationsResources and Assets b. Safety and Security

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c. Staff Roles and Responsibilities d. Utility Management e. Patient Clinical and Support Activities During Emergencies f. Volunteers: Licensed and Non-Licensed Professionals in a disaster

3. The EOP and associated policies and procedures and processes are designed to comply with The Joint Commission’s Emergency Management standard requirements, The Centers for Disease Control and Prevention, the California Code of Regulations, the National Fire Protection Association and the National Incident Management System (NIMS) requirements.

ORGANIZATIONAL DATA 1. The EOP is designed to assure appropriate staff response to a wide variety of emergency situations. The primary emphasis is on short-term management of critical patient care and business operations disruptions. This program is designed to address the emergency response needs of all patient care and business operations at Alameda Health System. The EOP applies to all personnel, contractors, and vendors.

2. Business Identification Subject Business Information Hospital Address 1411 E. 31st Street, Oakland, CA Telephone Number 510.437.4800 Website address www.AlamedaHealthSystem.org Hospital Leadership Delvecchio Finley, CEO Incident Command and CEO or designee in consultation with CNE and Authorized Personnel to execute Senior Attending in the Emergency Room EOP Operator Services Contains a list of the phone numbers of all essential personnel. Licensed Beds 236

3. Acute Facilities and Freestanding Clinics NAME ADDRESS Telephone Acute Facilities Administrative Offices Highland Campus 1411 E. 31st Street Oakland, CA 510.535.7220 Fairmont Campus 15400 Foothill Blvd San Leandro, CA 510.895.7305 John George Psychiatric 2060 Fairmont Drive San Leandro, CA 510.346.1364 Hospital Alameda Hospital 2070 Clinton Ave., Alameda, CA 510.814.4001 Creedon Advanced Wound 815 Atlantic Avenue Suite 100, 510.535.7434 Care Alameda, CA Park Bridge Rehabilitation 2401 Blanding Avenue, Alameda, CA 510-522-1084

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NAME ADDRESS Telephone South Shore Convalescent 625 Willow St., Alameda, CA, 510-523-3772 San Leandro Hospital 13855 E. 14th Street San Leandro, CA 510.667.4562

Freestanding Clinics Eastmont Wellness Center 6955 Foothill Boulevard Oakland, CA 510.567.5812 Winton Wellness Center 24100 Amador Way Hayward, CA 510.266.1744 Newark Health Center 6066 Civic Terrace Ave. Newark, CA 510.494.7232

DEFINITIONS

Terminology Definition

All Hazards The Homeland Security Presidential Directive defines “all- hazards" as preparedness for domestic terrorist attacks, major disasters, and other emergencies. Emergency A dangerous event that normally can be managed by the Medical Center. An emergency can be internal and/or external disruptions, natural or man-made disasters, events or catastrophes that significantly disrupt patient care and treatment, or that results in sudden or increased demands for AHS. Disaster A crisis response beyond the scope of local resources and usually overwhelms the community. Disasters are distinguished from emergencies by the greater level of response required. Emergency Management A government agency whose function is to assist during an Agency (EMA) Emergency - may be local, state, or federal. Health Alert Network Health Alert Network (HAN) is an internet-based system (HAN) designed to broadcast warnings of an impending or current emergency and links hospitals, paramedics, dispatch centers, law enforcement, public health officials and other healthcare system participants within local and regional communities. The California Health Alert Network (CAHAN) is an internet-based system deployed by California Department of Health Services, Emergency Preparedness Office. It is a secure information system restricted for California hospitals to state and local government disaster officials and response coordinators who are involved in contingency planning and management of disasters affecting public health. This system is capable of sending short message alerts to alphanumeric pagers, cell phones, e-mail addresses, faxes and telephones. Participants are alerted and directed to the CAHAN website for updated information about the emergency.

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Hospital Command Center The location where the Hospital Incident Command team coordinates activities during an emergency. It is managed using the Hospital Incident Command System (HICS).

Terminology Definition

Hospital Incident Command The management system used to manage and coordinate System (HICS) activities during an emergency. Incident Commander The person responsible for all aspects of an emergency response; including developing incident objectives, managing all incident operations, application of resources as well as responsibility for all persons involved. Job Action Sheet A document that includes an identification title, purpose, to who they report to, and critical action tasks. Job Action Sheets include action steps listed by time periods and the format allows for personnel to document each action undertaken and record decision timeframes. Local Emergency The Local Emergency Planning Committee (LEPC) is a forum Planning Committee for citizens, businesses, and government to share information (LEPC) and collaborate on disaster plans to improve the County’s preparedness for all hazards. AHS & Research Center Oakland participates in the following community emergency management planning activities: • City of Oakland—Emergency Management Disaster Preparedness Committee • Alameda County Emergency Management Association • Alameda County Vision Leadership • Alameda County Emergency Medical Services— Hospital Preparedness Program • California Hospital Association: East Bay Council of Emergency Managers and Safety Officers

Common Acronyms Definitions

EMA Emergency Management Agency EOC Emergency Operations Center HAN Health Alert Network Note: CAHAN is California Health Alert Network HCC Hospital Command Center HICS Hospital Incident Command System IC Incident Commander ICS Incident Command System JAS Job Action Sheet JIC Joint Information Center

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JIS Joint Information System LEPC Local Emergency Planning Committee LIP Licensed Independent Practitioner

Common Acronyms Definitions

NIMS National Incident Management System MOU/MAA Memorandum of Understanding/Mutual Aid Agreement PIO Public Information Officer

HAZARD VULNERABILITY ANALYSIS (HVA) 1. The Emergency Management Committee conducts a Hazard Vulnerability Analysis (HVA) of the medical center and outlying buildings to identify human, technological and natural vulnerability risks. Facility-specific risks, hazards and vulnerabilities are identified based on the probability of the occurrence. Probability is determined by the historical frequency of events in the community (e.g. fires, severe weather) as well as the consideration of the geographic location of the site to earthquake fault zones, flood plains, major transportation routes and neighboring sites. The level of preparedness, which is defined by what resources are available, offsets severity of the impact to the organization. A percentage is assigned to the hazard to make risk-based choices to address vulnerabilities, mitigate events, prepare for, respond to and recover from emergencies/disaster events. A summary of the results provide a way of prioritizing which hazards are in need of focus first and this drives the hazard specific planning. The Emergency Management Committee and Environment of Care/Safety Committee analyze the risk assessments, evaluate the reports and approve actions to address identified issues to implement procedures and to focus resources and planning efforts in the appropriate area(s).

2. Policy See the full content of the HVA Policy on AHS Policy Tech.

3. Results The HVA results are shared with the following community agencies: a. Fire and Police Departments b. Office of Emergency Services (OES), c. Emergency Medical System (EMS) Services, d. Alameda County and Contra Costa County Hospital Disaster Coordinators, e. Alameda County Emergency Medical Services (EMS) f. City of Oakland, And g. Oakland Office of Emergency Services (OES).

The needed resources and vulnerabilities are communicated to the community response agencies so the capabilities of the community are identified and are in line with the community priorities. Roles and responsibilities are discussed;

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funds for lacking resources are solicited (e.g. grants); and joint training and exercises are conducted to work on a coordinated and effective response. AHS has developed annexes and procedures for each high-risk hazard. The procedures include specific measures to mitigate, prepare, respond and recover each priority emergency. Responsibilities are also outlined.

96 HOUR CAPABILITIES AND SUSTAINABILITY AHS has conducted a 96 hour capabilities and sustainability assessment. This process is used to determine how long the medical center can sustain operations when the community cannot support the hospital. In this event, the Federal systems and the community are unable to support the medical center for at least 96 hours, the command team would assess critical supplies, medical care needs, staff resources and, in partnership with the local Emergency Management Agency, consider whether to close or evacuate portions or all of the facility, or continue under altered resources (e.g., water). The command team will make every effort to extend the use of the resources (e.g. conservation of resources, service reduction, partial staged evacuation and full evacuation, if necessary).

See the attached charts for AHS’S 96 Hour Assessment (Assumption that no external support would be available within 96 hours).

NATIONAL INCIDENT MANAGEMENT SYSTEM (NIMS) To align with Federal, State and local entities, AHS has integrated the NIMS elements into the organization’s plan to provide an effective and efficient structure for preparedness, incident and corresponding policies, procedures and annexes developed to address the emergency management phases: 1. The Mitigation Phase of emergency management involving proactive efforts to minimize the severity and impact of a potential disaster and reduce the potential for an event to occur. AHS’S activities are designed to reduce the risk and potential damage and include a. Structural construction projects to mitigate the facilities by reinforcing, bracing, anchoring, bolting, strengthening or replacement of the building. b. Non-structural hazard mitigation efforts include segregated storage of hazardous materials in secondary containment areas; conformance to building and fire codes as well as inspection, testing and maintenance of emergency systems (e.g. uninterruptable power supply (UPS) and back up of information systems data).

2. The Preparedness Phase involves the planning and training exercises, equipment acquisition and other management activities that build AHS’S capacity to manage the effects of emergencies as well as mobilize essential resources.

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3. The Response Phase involves putting preparedness plans into action. AHS mobilizes its resources and focuses on tactical activities to address a disaster event. The following response components include: a. Assume command and activate the Hospital Command Center (HCC). b. Recall staff through the overhead pageing system, pager, etc. c. Utilize the Hospital Incident Command System (HICS) to ensure there is a clear chain of command for effective management. Assign staff to hospital incident command staff positions and provide an initial briefing. d. Responders view incident action plan and obtain briefing(s). Work to meet incident objectives using procedures, annexes, checklists and forms. Initiate interim contingency plans to deal with system failures. e. Allocate scarce resources and coordinate with local response agencies. Request additional assistance from mutual aid partners, as well as the State. f. Request additional assistance from mutual aid partners as well as the State. In the event that response efforts in the local community cannot support the hospital, the hospital will continue to sustain services for up to 96 hours. The Medical Center Command Team will assess the situation throughout that time and determine whether evacuation or closure are feasible and reasonable based on the following criteria: i. Patient and Staff Safety, ii. Staffing Ratios iii. Resources and Supply Availability, and iv. Local Authority Mandates (e.g. Uniform Command).

g. Recovery Phase involves those efforts to resume critical support functions, continue the provision of care, and secure reimbursement funds if appropriate. The facility’s procedures, job action sheets and forms include demobilization/recovery actions to restore the services to normal conditions based on the manageable patient census using normal staffing patterns and resources and/or when other community responders begin their demobilization. Once the systems are restored for resuming normal treatment, the incident is evaluated to identify opportunities for improvement and develop initiatives to mitigate the effects of future incidents.

STAFF REPORTING STRUCTURE AHS’S Emergency Operation Plan is based on these key organizational systems: 1. The Hospital Incident Command System (HICS) is utilized as an effort to coordinate with the community responders. The Incident Command System is adaptable to meet the size and complexity of an incident by using recognized lines of authority and the model is in direct correlation with the County Emergency Operation Center, City, Fire Department, Police Department as well as neighboring hospital ICS structures. Staff report to the Incident Commander who is defined as being in charge of the response.

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2. The Multi-Agency Coordination System provides interactive management components and the organization structure of supporting agencies at the Federal, State, local and regional levels through mutual-aid agreements and other assistance arrangements.

3. The Public Information System is used for communicating timely and accurate information to the public during emergency situations.

4. Unified Command is in place when more than one agency or organization has command responsibilities such as during a hazardous material release when the fire department, Environmental Protection Agency (EPA), water authority and the hospital work together to analyze the information, and develop a common set of objectives.

ALL HAZARDS COMMAND STRUCTURE The Hospital Incident Command System (HICS) is an organizational and management framework used to execute a response to an incident/event and it is consistent with the emergency management system used in the community. The specific organizational structure established for any given incident will be based upon the needs of that incident and the Incident Action Plans will be developed as appropriate to the scope and duration of the incident. The ICS organizational structure described below is consistent with NIMS requirements and identifies key positions and lines of authority in response to an internal or external disaster situation. An ICS organization is composed of the Incident Command (IC), Command Staff, and the general staff with functions as shown below. The HICS Form 207 Organizational Chart is utilized during incidents to document assigned HICS positions.

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RESPONSIBILITIES AND AUTHORITY 1. The EOC/Emergency Management Coordinator is responsible for the overall management of the emergency management program including: program development; implementation and assessment; identification and control of risks; staff educational needs; and consultation, monitoring and assistance. The EOC/Emergency Management Coordinator serves as the Chairperson of the Emergency Management Committee.

2. The EOC/Emergency Management Coordinator represents AHS at city, county, regional, state and national planning meetings and coordinates overall preparedness efforts at AHS.

3. The Emergency Management Committee is a multidisciplinary improvement team, which includes administration, leaders, medical staff, clinical and support staff who are responsible for implementing and maintaining the Emergency Operation Plan (EOP) Standardized Operating Procedures and associated annexes, the annual evaluation, the Hazard Vulnerability Analysis (HVA), Exercise documentation, After Action Reports and performance improvement activities. The Emergency Management Committee reports to the Safety/Environment of Care Committee. 4. AHS Medical Staff and Administration ensure there is involvement with the organization’s leaders to plan and respond to emergencies.

5. Department Managers are responsible for orienting staff to the department and facility-wide emergency management procedures. Managers are also responsible for the development and management of specific department disaster policies and procedures (as applicable), ensuring that they are evaluated and revised (as appropriate), verifying all staff are trained on their individual roles and responsibilities consistent with the EOP; and staff participate in the implementation of the plan.

6. Employees are responsible for participating in training and demonstrating core competencies in the emergency management program. Employees receive emergency response training upon hire and annually thereafter. Employees must ensure their behaviors, work practices and operations are safe, and in accordance with departmental procedures, the provisions of the disaster plan, and clinical judgment.

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COMMUNICATION PLAN 1. Modes of Communication Available

The details of the communication program are outlined in the Communication Plan and Telephone Failure Plan

Type Meaning Annex / Policy Alphanumeric Can be used to communicate with a large number Pagers of staff provided with these devices. Hospital operators keep an active list of pager numbers and assignments. Amateur In times of crisis and natural disasters, Amateur Radio radio is often used as a means of emergency communication when wire line, cell phones and other conventional means of communications fail.

Unlike commercial systems, Amateur radio is not as dependent on terrestrial facilities that can fail. It is dispersed throughout a community without "choke points" such as cellular telephone sites that can be overloaded. Cell Phones Personal cell phones are an additional modality of communication. Some employees are provided with company cell phones. Email Electronic mail sent and received from internal/external sources. Facsimile Strategic departments have dedicated fax lines. The current list is maintained by telecommunications. GETS Card Government Emergency Telephone System (GETS) provides priority handling of phone calls placed over the public phone system via a universal access phone number and a PIN which identifies the caller. GETS is simply a calling card and is used like commercial calling cards. Instant May be used for continued one-to-one Messaging communication with one or more persons or facilities. Landline Landlines may be used for person to person Telephones communication or facsimile transmission.

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Type Meaning Annex / Policy Power Fail Power fail phones are associated with the Telephones internal PBX system and dedicated communication lines. This system will bypass trunks when the power fails. Repeater Utilized for very short-range two-way radio Radio service for business activities REDDINET ReddiNet is a flexible emergency medical communications network linking hospitals, regional EMS directors, paramedics, dispatch centers, law enforcement, public health officials and other healthcare system participants within local and regional communities. Runner Utilizing staff to provide foot traffic between two System or more points. For example, sending a runner from the Emergency Department to the Hospital Command Center (HCC).

2. Notification When Emergency Response Measures Are Initiated a. The Activation and termination of this plan is under the authority and direction of the Incident Commander. b. The Incident Commander will gather the following incident information: i. Whether a chemical or radiological substance was released. ii. The time of the incident. iii. The location of the incident. iv. The number of causalities and types of injuries. v. The number of trauma victims and ones that are ambulatory. vi. Whether decontamination is needed or being conducted on site. vii. The types of treatment given. c. The Hospital Command Center (HCC) has a primary and secondary location that is delineated in the SOP located in the Emergency Management Manual. d. The HCC contains preprinted HICS forms, Job Action Sheets, procedures and annexes; telephones and fax machines; computers with internet access; general office supplies; and a photocopier. e. The Labor Pool sites are activated on each campus and the location is announced at the time the decision to mobilize them are made. f. Employees are notified when the plan is activated by: i. Alphanumeric pagers ii. Telephones: landline and cellular iii. Overhead paging system iv. Email v. Word of Mouth g. Alert/Emergency management incident codes are:

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Alert / Emergency Meaning Management Incidents Code Red Fire or Smoke Emergency

Code Blue Adult Medical Emergency

Code White Pediatric Medical Emergency

Code Pink Infant Abduction Code Purple Child Abduction Code Yellow Bomb Threat/Suspicious Package

Code Gray Combative Person

Code Orange Hazardous Material Spill/Release

Code Silver Person with a weapon

Code Tan Scene Safety Initiated (Person presenting with penetration wound) Code Triage Internal Internal Disaster

Code Triage External External Disaster

Code “C” Emergency Cesarean Section

Heart Alert Patient presenting with Heart Attach (STEMI)

Alert / Emergency Meaning Management Incidents Airway Assist Cardiac Cath Lab requesting airway assistance

3. Ongoing Communication of Information and Instructions to Staff a. Once the emergency response measures are initiated, additional staff may be called in by: i. Utilizing the staff recall rosters. ii. The hospital public-address system: “Code Triage”. Details are outlined in the Code Triage Activation Policy. iii. Pagers, and

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iv. Telephone b. Information for staff and licensed practitioners can be distributed by: i. Alphanumeric pagers, ii. Telephones: landline and cellular, iii. Overhead paging system, iv. Email, and v. Intranet c. During an area-wide disaster (e.g., earthquake), the phones may be overloaded with calls or it may be impractical to call each staff member individually, therefore, alternative communication methods include: i. A recorded Disaster Information message on the AHS individual department lines. ii. KCBS radio public service announcements iii. Announcements placed on the AHS website. d. Internal communication is accomplished by obtaining information from different departments by: i. Telephones, ii. Cell phones, iii. Two-way radios iv. Pagers/text pagers v. Email vi. Overhead paging vii. Runners, or viii. Fax machines.

HICS Form 205 – Incident Communications Plan - will document what communication equipment is used and HICS Form 213 - Incident Message Form -provides a standardized approach for recording messages received. a. Additional communication available for communicating externally includes: i. Cell phones ii. Landlines iii. Amateur Radio Operators (HAM) iv. GETS v. Reddinet vi. CAHAN vii. Runners b. During an emergency or incident, standard terminology and plain language will be used for all communications. c. The Incident Commander will assign responsibilities. HICS 203 Form Organization Assignment List and HICS 204 Branch Assignment List will be utilized when assignments are made. d. Staff utilizes and completes the HICS forms to provide regular situation updates (e.g. HICS 201 Incident Briefing Form, 202 Incident Objective Form, HICS 251 Facility Systems Status Report).

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4. Notifying External Authorities of Emergencies The Hospital Incident Commander will assign a Liaison Officer to ensure external authorities are notified and necessary communication is maintained. The local Office of Emergency Services and other appropriate external agencies (e.g. EMS, police, fire) will be notified of any incident that overwhelms or has potential to deplete local resources. The District Licensing Office will be notified of the intent of discontinuance or disruption of services as outlined in Sections 70737 and 70746 of Title 22 of the California Code of Regulations (CCR).

5. Communicating with External Authorities once Response is Initiated To ensure connectivity between medical center and regional area once response measures are initiated. The Liaison Officer will provide regular communication updates to the Alameda County Emergency Operations Center (EOC) providing situation status and objectives, priorities and resource needs as well as resource availability (personnel and equipment). In addition, teleconferencing is utilized for communication updates.

6. Communication with Patients Including Relocation to Alternative Sites a. Patient communication is coordinated through the Hospital Command Center. b. Outpatients receive information through Ambulatory Care Sites which may include: i. Messengers ii. Telephone calls, or iii. Press releases through the Public Information Officer (PIO). c. Inpatients depending on the acuity of the patient will receive briefings of pertinent information by: i. Flyer delivered by designated staff or ii. Overhead page announcements. d. If patients are relocated to an alternative site, patients and their families will receive regular briefing consistent with regulations regarding patient confidentiality information including: i. The general condition of the patient ii. The alternate care site name and address iii. The anticipated timeframe from relocation to the alternate care site. iv. The hospital will establish Family and Patient location and tracking system.

7. Communication with the News Media – Circumstances and Plans Details of the program are outlined in the Communicating with Media, Patients and Community Policy. a. AHS maintains a cooperative relationship with the news media, which balances the public need for information with the responsibility to safeguard the patient’s right for privacy. b. Communication is coordinated through the assigned PIO. The PIO is responsible for developing informational summaries for reporters so that timely and accurate information is provided to the public during

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emergency situations. In addition, the PIO is the spokesperson for AHS and is responsible for media and public inquiries, rumor response, and media monitoring. c. The media will be informed of the number of victims and types of emergencies. No names will be released without the approval of the Incident Commander. d. Media personnel will use their own communication systems and will be directed as to staging, interviewing, and new conference locations. e. Handling questions from the media is addressed according to the Administrative Policy and the Media Policy. f. If the Joint Information Center (JIC) is established, the PIO will participate to address communication and public education efforts. g. A media center will be the responsibility of the PIO. Security/designee will ensure that all members of the media have credentials, are approved to be on the AHS property and confined to the designated area as per the Hospital Commander. h. Media camera trucks will not be permitted on any AHS property. No media vehicles will be allowed in any other area of the hospital campus.

8. Communication with Purveyors of Essential Supplies The Logistics Section Chief and Operations Section Chief will contact vendors that provide essential resources and supplies. The memorandums of understanding (MOU) include the vendor contact information. The list of vendors is located in the Hospital Resource Directory (HICS Form 258) and the departments that are identified as providing essential services in the Standard Operating Procedures.

9. Communicating with Healthcare Organizations in the Geographic Area and Essential Elements in Command Structure AHS meets regularly with the Alameda County Hospital Disaster Coordinators to ensure cooperative planning among healthcare organizations that provide services to a contiguous geographic area thus facilitating the timely sharing of information about: a. Essential elements of their command structures and control centers for emergency response. b. Names, roles, and telephone numbers of individuals in their command structures. c. Resources and assets that could potentially be shared or pooled in an emergency response. d. Names of patients and deceased individuals brought to their organizations to facilitate identification and location of victims of the emergency. e. Usage of common communication equipment and data sources to allow for communications when the infrastructure (e.g., phone

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lines, computer lines) has been impacted. The Hospital Resource Director (HICS Form 258) is utilized. f. The above information is kept in the Hospital Command Center. To ensure that the command structure information is current, the EOC/Emergency Management Coordinator is responsible for managing this task.

10. Patients and Deceased Individuals a. The Alameda County Hospital Disaster Coordinators Disaster Team planning includes the sharing of names of patients and deceased individuals brought to the organizations to facilitate identification and location of victims of the emergency. b. At AHS, patients and deceased individuals are identified and communicated to the Patient Affairs and the American Red Cross if on site. Specific policies (e.g. Forensic Plan) outline third party communication protocols including the FBI, Alameda County Sheriff’s Department, Oakland Police and the Public Health Department. After approval by the Incident Commander, the Public Information Officer provides updates and briefings to staff, visitors, families and the news media. c. The Mass Fatalities Procedures as well as the policies governed by the Morgue, provides guidelines for dealing with mass fatalities in Unified Command with Alameda County and to properly process human remains in a safe, secure and respectful manner and assist the decedents’ family members.

11. Family Assistance Center a. The Community Emergency Operations Center (EOC) and the American Red Cross will coordinate, manage and staff the Family Assistance Center (FAC). Local agencies, the Salvation Army, faith- based organizations, churches and other applicable organizations work collaboratively to provide emotional support services and interpreter services (based on impacted population). b. AHS may provide information and resources to the local Family Assistance Center (FAC) to support the family/friends and to provide answers to questions, concerns and assist with family reunification services. In the event the Family Assistance Center has to be located at AHS, this area will be in a private location away from the media.

12. Communication with Alternate Care Sites The Local Public Health Department is the responsible agency to establish the Alternate Care Sites for the general public. AHS has the authority to establish an Alternate Care site within its properties.

The Hospital Command Center will provide the alternate care site with briefings as to the status of the operational capability, and the anticipated need for

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assistance to receive or transfer patient should it become necessary.

13. Back Up Communication In the event that the community infrastructure is damaged and/or AHS experiences a communication failure, redundant and alternative communication systems are in place and they include: a. Voice systems: landlines telephones, power fail (by-pass) telephones, cellular, and amateur and handheld commercial two-way radio and GETS cards (a service that allows authorized federal, state and local government, and industry personnel to complete phone calls when normal or alternate telecommunication methods are unsuccessful) will be used. b. Runners c. Data systems include computers with modems on analog lines, computers on wi-fi to access and utilize email, Reddinet. d. Equipment for receiving public broadcasts includes multiple televisions and AM/FM radios. e. The Hospital Command Center houses preprinted HICS forms, job action sheets, procedures and annexes; general office supplies, fax machine and photocopier.

AHS meets regularly with the East Bay Council of Hospital Emergency Managers and Safety Officers to ensure there is a coordination of common equipment and data sources in the event infrastructures (e.g., phone lines, computer lines) are negatively impacted. Common resources have been established with the local hospitals to be used during incident responses.

RESOURCES AND ASSETS Obtaining Required Supplies at Onset of Response 1. Key aspects of a disaster response are pre-designated in advance through the Emergency Management Committee. During an emergency response, the Hospital Command Center will coordinate the allocation of resources, based on need and priority. The management of Logistics is managed through the Logistics section within the Hospital Incident Command System. Memorandums of Understanding for additional supplies, equipment and food have been established. These include, but are not limited to: a. Generators b. Medications c. Water d. Fuel e. Medical supplies f. Food g. Batteries h. Linen i. Cots

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j. Refrigeration Truck(s) and k. Waste containers

2. The existing inventory will be utilized first upon activation of the HCC.

3. If additional resources are needed, supplies for disaster response (triage, decon, etc.) are stored in caches on-site.

4. Disaster credentialing policies for medical staff and other volunteers will be utilized to augment staff if needed through the Labor Pool and Credentialing Unit.

5. When the existing inventory of critical supplies are at minimal PAR levels, outside vendors will be contacted. The Alameda County EOC can be contacted to facilitate requests, access and distribution of additional supplies.

6. An updated Vendor Emergency Contact List is available in all essential service departments.

Replenishing Pharmaceutical Supplies Chempacks, the national cache of chemical antidotes, and other drugs and medical supplies deployed after a biological, radiological, or chemical attack are housed in the facility and are available and managed by the Pharmacy, if needed. See the Bioterrorism and Chempack policies for details.

Replenishing Non-Medical Supplies 1. Food: A 96 hour food plan has been created by the Food and Nutrition Department. Additional food supplies have been ordered for the Ambulatory Care Services sites.

2. Linen: A five day PAR level is maintained on site. In addition, an MOU is in place with the vendor.

3. Bottled drinking water in boxes in the Food and Nutrition Department. If additional drinking water is needed until normal services can be restored, arrangements have been made with such vendors. In the event 96 hours of water is not available at the time of true need and the facility is unable to obtain additional supplies, a decision will be made 24 hour prior to exhaustion of water resources by the Command Team to stage an evacuation.

4. Plans for use of water for utilities have been developed by the Engineering department and identified in the Utilities Management Plan.

5. Generators: The generators are located and housed on AHS properties. The fuel tanks for the diesel system and support equipment are buried and have double- walls as well as a system to monitor for fuel leaks. The facility has 72 hours of diesel fuel and a conservation plan to extend to 96 hours. In the event additional

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fuel is needed, the Engineering Department will communicate this to the Hospital Command Center.

6. Transportation resources onsite include passenger vans.

7. Available personal protective equipment resources are housed in Materials Management and storage facilities within the properties.

Managing Volunteers and Staff 1. Disaster credentialing policies for medical staff and other volunteers will be utilized to augment staff if needed through the Labor Pool and Credentialing Unit. The Medical Staff Office and the Human Resources departments are responsible for reviewing and recommending the policies for acceptance by the Emergency Management Committee.

2. HICS Form 252 – Section Personnel Time Sheet is augmented by existing systems to record each Section’s personnel time and activity. Each department is required to have staff sign- in upon activation of the emergency plan.

3. The Incident Commander is empowered to authorize volunteer caregivers to assist hospital staff in the event that the organization is unable to meet immediate patient needs without volunteers.

4. The Medical Staff has policies in place and is responsible for granting privileges to the Volunteer Licensed Independent Practitioners (LIP). Refer to the Medical staff offices.

5. Before a volunteer practitioner (those licensed and those who are not licensed independent practitioners) is considered eligible to function as a volunteer, the hospital obtains the volunteer’s identification as outlined in the disaster credentialing policy. This policy also outlines processes for supervision, communication and management. The Graduate Training Program maintains policies for House Staff expectations, roles and responsibilities during a disaster.

6. HICS Form 253 – Volunteer Staff Registration is used for Volunteers to sign-in for an operational period in accordance with the Hospital Command Center’s delegated authority and job action sheets.

Managing Staff Support Activities The Support Branch Director under the Logistics section manages staff support activities. Additional resources are requested through the County EOC. Current available resources include: 1. Housing for staff will be provided where possible on the property and through use of existing contracts with local hotels.

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2. Transportation resources on site include passenger vans and a fleet of vehicles. BART mass transit is located outside the facility.

3. Incident stress debriefing and counseling is coordinated through the Employee Assistance Program (EAP) as per AHS’S Human Resources policy. The Hospital Chaplain’s Office will be the primary communications center for all chaplain coverage and support needs. The chaplains will help be available to assist staff when requested.

Managing Staff and Family Support Needs Staff Family Support activities are under the jurisdiction of the Logistics section. AHS strives to prepare staff personal readiness by encouraging staff to prepare for emergencies at home. One example is encouraging staff to have a readiness bag and plans for dependent care is provided during orientation and drills. 1. Employees will be able to call family to ensure their safety.

2. Staff is encouraged to be good pet care providers by making provisions prior to an emergency at kennels.

3. Childcare will be provided and coordinated through the Hospital Command Center should the need arise.

Potential Sharing of Resources and Assets with our other Hospitals 1. AHS and the community participate in statewide exercises and community-based planning. To promote inter-operability, AHS representatives meet regularly with the Alameda County Hospital Disaster Coordinators to prioritize plans to support the community. This includes identifying the resources and supplies that will be available for an emergency response and comparing it with what they may need in an emergency. Gaps between on- hand resources and needed resources are supplemented by Mutual Aid agreements with local hospitals. AHS is part of Coastal Region II, one of the six regions responsible for the coordination of disaster mutual aid designated by the California State Governor’s Office of Emergency Services. During a declared local emergency, an Operational Area Emergency Operations Center (EOC) is activated to provide resources from the non-impacted areas. AHS has agreements with other hospitals in Alameda County to share facilities, supplies, equipment, and personnel resources in the event of a defined disaster in order to provide essential services to the community.

2. Biomedical Engineering will inventory all critical equipment not in use. In additional clinical equipment is needed contracts with vendors and suppliers for critical equipment and supplies are available. The establishment of contracts prior to a disaster is overseen by the Materials Management Department.

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3. In the event, resources/assets needed to be shared with other hospitals, the Command Team at AHS is responsible for making decisions on whether resources can be shared and what quantities, after reviewing what resources are needed to maintain services at AHS.

4. The Procurement Leader utilizes the HICS Form 256 Procurement Summary Report to track procurements. This document includes purchase order information, dollar amount and vendor. Requested equipment is recorded on HICS Form 257 Resource Accounting Record to document what was received, the condition of the resource and when it was returned.

5. Requesting 1135 Waiver - under section 1135 of the Social Security Act, the Secretary may temporarily waive or modify certain Medicare, Medicaid, and Children’s Health Insurance Program (CHIP) requirements to ensure that sufficient health care items and services are available to meet the needs of individuals.

Review of 1135 Waiver requests - EH&S will provide initial consultation and completion of waiver for AHS. CMS will review and validate the 1135 waiver requests utilizing a cross- regional Waiver Validation Team. The cross-regional Waiver Validation Team will review waiver requests to ensure they are justified and supportable.

Implementation of 1135 Waiver Authority

Providers must resume compliance with normal rules and regulations as soon as they are able to do so, and in any event the waivers or modifications a provider was operating under are no longer available after the termination of the emergency period.

Potential Sharing of Resources Outside of the Community Coordination of healthcare resources and assets outside of the operational area during an event is a State of California Regional EOC function and responsibility. The County Emergency Operations Center (EOC) ensures that those who are located at the scene have the resources (i.e. personnel, tools, and equipment) they need for the response and also acts as a liaison between local responders and the Stated.

The Chempack is one of the mutual aid resources that may be deployed to other nearby sites.

Transporting Patients, Medication and Equipment to Alternative Site 1. In the event of a surge, all inpatient cases will be assessed for the ability to discharge early to increase the bed capacity. In addition, an initiation of auxiliary treatment as outlined. See the Surge Plan for details.

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2. Evacuation procedures for complete and partial evacuation of the hospital are current and are reviewed regularly (See Evacuation Plan). In the event of a fire or other internal emergency, patients will be relocated to another safe part of the hospital.

3. In the event the hospital is deemed unsuitable for continued occupancy or cannot support adequate patient care, the Incident Commander will authorize evacuation. The Operations Section Job Action Sheet and the Evacuation Plan provides guidance for preparing patient records, medications, biomedical equipment and valuables for transfers as well as confirm the transfer and timeline with accepting hospitals.Evacuation equipment includes: evacuation chairs, litters, and sheets.

4. Agreements are also in place with AMR ambulance services and neighboring facilities to transfer patients as necessary and this is coordinated though the County EOC.

5. HICS Form 255: Master Patient Evacuation Tracking Form is utilized by the Patient Tracking Manager to record information concerning all patients disposition during an evacuation. The Medical Care Branch Director utilizes the HICS Form 260 Patient Evacuation Tracking Form to document details and account for each patient transfer to another facility.

Transporting Clinical Information to Alternate Care 1. AHS has entered into a Mutual Aid Agreement with other facilities within the area, which could accept patients in the event of an evacuation.

2. The Operations Section is responsible for providing patient information as appropriate and ensuring the family is notified of the patient transfer. The Planning section tracks patients and personnel to the alternate care site. The HICS-254 Disaster Victim/Patient Tracking Form is used. Qualified hospital staff will accompany the patients. Periodic information sharing will occur between the hospital receiving victims through telephone or other communication methods (e.g. internet). AHS staff will take appropriate steps to ensure patient information remains confidential even during emergency conditions.

Safety and Security Internal Security and Safety Operations 1. Safety is a priority at AHS. The assigned Safety Officer will document actions taken to mitigate hazards on HICS Form 261 Incident Action Safety Analysis.

2. Security access, crowd control and traffic functions are managed through the Security Branch Director Position of HICS. Depending on the type of incident, increased vigilance/patrolling; increased monitoring of ID badges and the securing of non- critical doors will be implemented. Ongoing security measures are in place for identifying staff, visitors and patients:

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a. Patient wrist bands, b. Staff identification badges, c. HICS vests, d. Visitor badges, and e. Contractor badges

3. Employees are required to wear their ID badges when working in the facility. I.D. Badges can be obtained from the Security Department.

4. Security personnel may be augmented as required through the pre-arranged contract service, Securitas, and/or labor pool. Prior to working in the security role capacity, labor pool staff will receive appropriate training including protocols, handling abusive behavior, etc. 5. All employees must immediately report any suspicious person(s) or activities to Security.

6. AHS has a process for lock-down and shelter in place. See Lock-Down and Shelter In Place Policies.

7. Patient Belongings during a surge incident will be stored in labeled patient belonging bags in a locked room. Security and Transportation storage room is designated for storage.

8. In incidents of special circumstances (e.g. bomb, bioterrorism), chain-of-custody procedures will be followed. Evidence obtained from the Emergency Department (ED) is placed in the locked cage adjacent to the ED.

Identifies Roles of Community Security Agencies and Coordination 1. AHS contracts with the Alameda County Sheriff’s Department for law enforcement services that are provided on a 24/7 basis on the Highland Campus. In addition, AHS contracts with Healthcare Security Services for security services on all campuses.

2. The Security department works collaboratively with the Alameda County Sheriff’s Department (ACSD). The ACSD provides AHS with prompt response when needed and also shares local crime statistics and informational warnings to ensure AHS has current local information.

3. The Security Branch Director will identify material resources for rent or purchase (e.g. barriers, fencing, storage). The Hospital Command Center Liaison will notify the local EOC of the current situation.

4. Requests for law enforcement mutual aid functions will be placed through County EOC. HSS has the ability to expand its staff through their chain of command.

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5. The Unified Command system will be established between AHS and the responding agencies to ensure a safe, effective response.

Process for Managing Hazardous Materials – Radioactive, Biological and Chemical 1. AHS is equipped to manage decontamination with specified chemical agents, provided the agent and concentration are known. Internal spill and know agent response plans: The Hospital has the capability for incident decontamination, using the decontamination showers and equipment. Selected staff are trained to provide decontamination. When agent is known, decontamination will be under the jurisdiction of the local emergency response agencies.

2. Radiological exposures are managed in partnership with the Radiation Safety Officer. See Radiation Response PlanBiological exposures will be handled in the same manner as chemically contaminated patients once the agent is known. Infection Control will be notified and provide consultation in the capacity of a Medical/Technical Specialist. Initial patients may enter the ED without knowledge of the contamination. Typically biological agents have a latent period and therefore patients presenting to the ED will no longer be contaminated and will need to be treated according to the agent involved. If the agent is communicable, the patient will be placed into an isolation room or cohorted with patients that have like symptoms/diagnosis. See Bioterrorism/Biological Agent Guidelines from the State of California.

3. Contaminated patient belongings will be labeled and stored in the appropriate bags to avoid cross-contamination.

4. Hazardous waste procedures for labeling, storage, and disposal are outlined in the Hazardous Waste Management Program.

Control Movement of Individuals within Health Care Facility The lock down plan can be implemented to control admission to the entrance and other doors. Depending on the incident type, the Hospital Command Center will determine what controls (e.g. decontamination, isolation) will be put into place prior to patients entering the facility in regards to keeping the facility secure and safe. The Hospital has triage tags for use in emergency situations to identify, process, and triage patients and provide a means to identify clothing and other personal property. Incoming patient information will be transmitted from triage to the Hospital Command Center. Patient care updates will be transmitted to the HCC using logging system implemented at each treatment unit. The Patient Affairs Officer, working with Family Center staff will coordinate notification of the patient’s family and release of patient information to family with the American Red Cross.

Control Traffic Access Health Care Facility 1. ACSD and Security will be responsible for external vehicular flow of traffic, which would prioritize emergency vehicles, and all other necessary traffic flow to the area.

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2. If more help is needed than can be provided by local law enforcement agencies, who will be contacted for assistance. Additional officers are made available through normal procedures used by the ACSD, if needs arise with the County EOC.

3. In the event of closure or rerouting of the streets, staff, patients, and visitors will be notified by signs and through the public media and detour signs will be obtained and placed around the perimeter.\Staff Roles and Responsibilities

Staff Roles are Defined in the EOP Roles and responsibilities of staff are outlined in the Emergency Management Manual. The Hospital Incident Command System is used to ensure there is a clear chain of command for effective management. Positions are filled based on the size of the incident and Job Action Sheets are used for defining and performing a specific emergency response functional role. Incident Response Plans are also used during an incident, which lists decision considerations specific to managing that situation by timeframe and complement the facility procedures.

Staff Are Trained for Assigned Roles The Emergency Management Committee designs drills and exercises with scenarios and objectives based upon findings from the hazard vulnerability analysis as well as from critiques from past exercises and/or actual events. These events provide staff with the opportunity to practice and train for their roles during an emergency. Personnel are assigned to the various command positions, and receive a briefing and Job Action Sheet that outlines the responsibilities and actions for that specific assigned job function. 1. Mangers are responsible the development and management of specific department disaster policies and procedures. Managers are also accountable for ensuring that the plans are evaluated and revised and verifying staff are trained on their individual roles and responsibilities during a disaster/emergency event. Managers train staff on the emergency codes and explain the roles and duties associated with activating codes.

2. MIMS training is provided to hospital personnel that would have a role in emergency preparedness, incident management, and/or emergency response during an incident as a means of preparing personnel to competently assume one or more roles based on situational need and resources available.

3. HICS is utilized, so when personnel are assigned to the various command positions they receive a briefing and a Job Action Sheet that outlines the responsibilities a Job Action Sheet that outlines the responsibilities and actions for that specific assigned job function.

Organization Communicates to Licensed Independent Practitioners 1. The Chief Medical Officer and/or the President of the Medical Staff represents the physicians in the Incident Command Structure.

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2. The Emergency Department Staff has received documented training on HICS/NIMS and the EOP. All of the medical staff members have received information on AHS’S EOP and applicable emergency procedures.

3. Licensed Independent Practitioners (LIPs) have roles and responsibilities defined on job action sheets (e.g. Operations Branch pertaining to patient care).Process for Identifying Care Providers During Emergency

4. Employees are required to display their employee identification badges. If an employee does not have his/her badge or it cannot be located, temporary badges can be obtained through the Security Department, upon verification that they are employees.

5. Personnel are assigned through the Hospital Command Center to cover positions and functions in the Hospital Command Center to cover positions and functions in the Hospital Incident Command Center. Employees are provided with vests that clearly indentify the HICS position title.

The Incident Commander is empowered to authorize volunteer caregivers to assist hospital staff in the event that the organization is unable to fully meet immediate patient needs without volunteers. Occupations that fall under Licensed Independent Practitioner (LIP) and Allied Health Professional (AHP) are covered under the Medical Staff Bylaws and Policies covering disaster privileges. The credentials of volunteer providers will be verified through the Medical Staff Office.

MANAGING UTILITIES DURING EMERGENCIES Alternative Means of Providing for Utilities

In the event that the utility is compromised or disrupted, procedures and contingency plans are detailed in the Emergency Management manual for each specific utility. These plans are coordinated in advance to ensure the extent practicable, there is uninterrupted service. External options and contracts for essential services are coordinated through Hospital Command Center (Logistics section). The acquisition of equipment parts or outside contractors will be coordinated with the Support Branch.

1. Electricity (Emergency Power): is provided by onsite generators. Contracts are in place for backup generators.

2. Water for consumption, equipment and sanitary purposes: Food and Nutrition Services manages and stores water for patients and staff. Engineering developed plans for water use and disruption.

3. Fuel (#2 Diesel fuel) for building operations is stored onsite and contracts are managed by Engineering Services for replacement fuel.

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4. Sanitary Sewer System: is maintained by Engineering Services and procedures are in place for responding to leaks or disruptions.

5. Fire Alarm or Automatic Sprinkler System is out of service: See Interim Life Safety Measure Program.

6. Medical Gas/Vacuum: Engineering Services manages the fixed medical gas and vacuum system. Procedures are in place for malfunctions and disruptions. Materials Management manages the contracts for the tanks and they oversee the storage process.Heating and Air Conditioning (HVAC): Engineering manages the heating and air system and has response procedures for disruptions and equipment failure.

MANAGING PATIENT CLINICAL AND SUPPORT ACTIVITIES The Clinical Activities: Patient Scheduling, Triage, Assessment, Through Discharge 1. Scheduling, modifying or discontinuing services is done under the coordination of the Operations section. Patient care schedules are reviewed to determine if early discharges, elective surgeries can be postponed or alternative care would beneficial to the patient(s).

2. Peri-operative Services will inform the HCC of the cases currently in surgery and expected closure times. Surgery in progress will be completed as soon as safely possible. No new cases will be started until authorized by the IC.

3. The Labor Pool may be activated by the Incident Commander to collect and inventory staff and volunteers at a central location. The Labor Pool and Credentialing Unit will receive requests and assign available staff as needed, and maintain adequate numbers of personnel to ensure patient care is appropriate.

4. The triage process generally occurs outside the Emergency Department to determine who needs further evaluation/medical care. The patient’s treatment area and the severity of the injuries are documented on a triage tag. Simple Triage and Rapid Treatment (START) is used to separate the patients into four groups: a. Immediate Care: Patients need advanced medical care at once and are in critical condition and would die without immediate assistance. b. Delayed Care: Patients are in stable condition but require medical assistance. c. Minor: Patients need first aid and not in need of advanced medical care. d. Deceased: Patient not breathing and an effort to reposition the airway have been unsuccessful.

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5. Staff that received training and have practiced decontamination procedures may receive patients contaminated with hazardous materials. Patients will be decontaminated prior to leaving care unless lifesaving interventions are necessary first.

Clinical Services for Vulnerable Populations Patients that have clinical needs (e.g. chronic conditions) that fall outside of the scope of services or ability of the organization to care for them will be transferred to another healthcare facility with capable resources to provide appropriate care. In the event transferring a patient is not immediately possible, Planning and Operations will work together to obtain the appropriate resources (e.g. staff, medications for anxiety etc.) to maintain appropriate delivery of care. The activation of the HICS Mental Health Unit Leader will be implemented in the event patients with mental health needs are present.

Personal Hygiene and Sanitation Needs The Operations Section Chief and Infrastructure Branch Director are responsible for hygiene and sanitation needs are met. Infection Control will be included in decision- making processes. 1. Procedures for bring in additional portable toilets and hand-washing facilities if the emergency toilets stored in the disaster supply cache are not sufficient.

2. Using antimicrobial soap and water, alcohol-based products located in Environmental Services (EVS). In addition, portable water trucks will be hooked up to the facility and water bladders utilized. Waterless bath packets stored on the units can be utilized when water service is lost.

3. Existing Infection Control policies will be used to support operations.

Mortuary Services The current morgue capacity is 12 patients, and if needed to be augmented in disaster, AHS utilizes the Mass Fatalities Procedure and the Alameda County Coroner’s Plan that details handling mass casualty incidents which, ensures the safe handling and storage of decedents until the Coroner can respond.

Documenting and Tracking Patient Clinical Information 1. The Casualty Care Unit Leader will coordinate triage and treatment activities. Once the patients are triaged, they are tagged with a triage tag, admitted and the clinical information is documented on the tag. Each patient is assigned and identified by a unique control number. This number is printed on the triage tag; medical forms/requisitions; patient valuables envelope; and patient wristband. HICS Form 259-Hospital Casualty/Fatality Report is used by the Patient Tracking Officer to document the number of injuries and fatalities.

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2. Information Systems downtime policies and procedures for managing clinical information will be utilized to document and track patient clinical information during the event of an unplanned information technology system outage.

Victims that are Disabled and/or at Risk 1. Victims with disabilities and people who are vulnerable or at risk and cannot comfortably or safely use some of the standard resources offered in a disaster situation. All attempts will be made not to separate these victims from their families and to meet their needs. A point person(s) will be assigned to assist these victims and if possible a hospital a staff person will be assigned to assist one or two victims. Information on all victims with special needs will be reported to the HCC. All efforts to contact organizations that represent the interests and rights of individuals with disabilities to request assistance in treatment and placement. All patients with special needs who are admitted will be referred to a social worker/case manager. All patients transferred to another facility will have a list of their special needs to accompany them and if necessary a volunteer to assist with the transfer. All patients discharged from the hospital will be evaluated for any special needs required for home care, relocation for sheltering or temporary residence.

Curtailing Services When services need to be curtailed due to jeopardy to patient or staff safety, the Incident Commander will develop a detailed plan and communicate the objectives of the plan both internally and externally to the appropriate parties and authorities. This plan will include: reasons for curtailment, movement of patients, staging patients, tracking patients, transporting patients, and the communication process closing the hospital to new patients.

TESTS ITS EOP 1. The Organization Tests its EOP Twice a Year Drills and exercises are conducted at least two times each year, either in response to an actual emergency or in a planned exercise. Documentation is located in the Scalable Event and Disaster Drill Binder.

2. Conduct At Least One Exercise A Year That Includes Patient Influx To ensure staff gain the opportunity of preparation for an emergency, at least one drill scenario includes an influx of patients. This process allows staff to practice using the disaster plan as well as teach them how to handle multiple patients when they are working in unusual conditions.

In addition, at least one planned exercise involves an internal disaster that may include a scenario where the hospital cannot be supported by the local community or evacuation. In addition, tabletop drills involving the community and hospital are conducted to evaluate the community’s emergency response plan.

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3. Exercise Scenarios Are Realistic and Related to HVA Priorities The Emergency Management Committee designs drills and exercises with scenarios and objectives based upon findings from the hazard vulnerability analysis as well as from critiques from past exercises and/or actual events. In addition, AHS participates in exercises designed by the State or local community that have scenarios based on risk in the geographical location.During Planned Exercises, An Individual Monitors Performance

During planned exercises, the hospital designates an evaluator to observe at least the following core performance: a. Communication: the effectiveness of communication internally, as well as external communication with emergency response agencies, public health and other healthcare organizations within the community. b. Resource mobilization and availability including assets, personal protective equipment and supplies. c. Safety and security. d. Event notification: including activation of the Hospital Incident Command System (HICS); notification of staff and external authorities and staff roles and responsibilities. e. Patient management: including triage activities, patient identification and tracking and support, staff roles and responsibilities. f. Utility systems. g. Patient, clinical and support care activities.

4. Exercises/Real Events are Critiqued to Identify Deficiencies and Improvement Once the exercise is concluded or real events occur, they are critiqued through a multi- disciplinary process that includes administration, clinical staff, medical staff and support staff. Deficiencies or improvements are identified and documented in an After Action and Corrective Action Report. The findings from the critiques including strengths and weaknesses are communicated to the Environment of Care/Safety Committee and forward through for review by other committees.

REFERENCES Applicable and Regulatory Standards: 1. California Code of Regulations, Title 22

2. Centers for Medicare and Medicaid (CMS)

3. The Joint Commission Comprehensive Accreditation Manual for Hospitals EM.01.01.01, EM.02.01.01, EM.02.02.01, EM.02.02.03, EM.02.02.05, EM.02.02.07, EM.02.02.09, EM.02.02.11, EM.02.02.13, EM.02.02.15, EM.03.01.03

4. National Incident Management System

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5. NFPA 1600

APPROVALS

System Alameda AHS/Highland/John George/San Leandro Department Date: N/A 02/2020 02/2020 Pharmacy and Date: N/A N/A N/A Therapeutics (P&T) Clinical Practice Date: 06/2020 N/A N/A Council (CPC) Medical Executive Date: N/A 07/2020 07/2020 Committee Board of Trustees Date: N/A N/A

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EXTERNAL NOTIFICATION

Department Environmental Health and Effective Date 01/2009 Safety Campus AHS System Date Revised 11/2008, 11/2011, 04/2020 Category Administrative Next Scheduled Review 08/2023 Document Director, Environmental Executive Responsible Chief Quality Officer Owner Health and Safety Printed copies are for reference only. Please refer to electronic copy for the latest version.

PURPOSE To communicate to external agencies regarding Alameda Health System’s (AHS) emergency response activations (e.g. fire, mass casualty incidents, evacuations, hazardous materials releases, active shooter events, outbreaks, etc.)

POLICY AHS will notify and alert external Emergency Operation Centers of AHS’ activation and situation status.

PROCEDURE AHS to External Partners: 1. When AHS activates a Code Triage, the Liaison Officer will notify within the hour, the Alameda Public Health, and EMS Departments about its activation, current bed census and any resource request needs.

2. External agencies may contact AHS via the System-wide Hospital Command Center’s main phone number during activations.

3. Ongoing communication will occur until deactivation is complete.

External Partners to AHS: 1. During normal operations (non disaster periods) external agencies will be directed to notify the Director of Environmental Health and Safety or contact the main number of the hospital and request the House Supervisor.

RESOURCE The Joint Commission Comprehensive Accreditation Manual for Hospitals – EM.02.01.01

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125/288 APPROVALS

System Alameda AHS/Highland/John George/San Leandro Department Date: N/A 04/2020 04/2020 Pharmacy and Date: N/A N/A N/A Therapeutics (P&T) Clinical Practice Date: 06/2020 N/A N/A Council (CPC) Medical Executive Date: N/A 07/2020 07/2020 Committee (MEC) Board of Trustees Date: N/A N/A

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126/288

GUIDELINES FOR HOUSE STAFF CORRECTIVE ACTION

Department Graduate Medical Effective Date 10/2019 Education Campus AHS System Date Revised 06/2019, 06/2020 Category Clinical Next Scheduled 08/2023 Review Document Owner Director, Graduate Executive Chief Medical Officer; Medical Education Responsible Associate Chief Medical Officer Printed copies are for reference only. Please refer to electronic copy for the latest version.

PURPOSE 1. To ensure adequate and professional quality of trainees in Post-Graduate academic programs.

2. To provide a system to address House Staff Performance.

3. To provide a system to review disciplinary actions against House Staff members and ensure the principles of due process have been met.

POLICY Definitions 1. House Staff/Officer: An Intern or Resident in a training program.

2. Preceptor: An assigned faculty member mentor for a House Officer

3. Training Program Director: Director of Surgery, Internal Medicine, Emergency Medicine, or Oral Surgery residency training programs.

4. Designated Institutional Officer (DIO): the physician director of Graduate Medical Education

5. Clinical Competency Committee (CCC): A group of faculty members who regularly assess house staff progress in a training program.

6. House Staff Record: The permanent file kept by the Program Director for each House Officer containing evaluations, applications, reference letters, etc.

7. Chief Medical Officer (CMO): The Chief Medical Officer of the Alameda Health System.Letter of Concern: A written communication from the Program Director to the House Officer, which is in addition to routine evaluations and states deficiencies under review.

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8. Coaching Plan: A tool to assist house staff after a Letter of Concern has been communicated to support professional development in one or more ACGME Core Competencies.

9. Structured Learning Plan: often concurrent with the Letter of Concern, the Structured Learning Plan is a formal series of obligations and expectations on the part of both the program and the house staff designed to remediate the issues that prompted the issuance of a Letter of Concern and a Coaching Plan.

10. Probation: A formal disciplinary modification of a house staff’s participation in or responsibilities within the training program; these modifications are designed to facilitate the house staff’s accomplishment of program requirements. If there are still areas of unsatisfactory performance, the house staff will not be permitted to continue in the program.

11. Graduate Medical Education Committee: a committee composed of training program leadership and select core faculty, members of the AHS administration (CMO, Quality director, e.g.) house-staff representatives; chaired by the DIO and administered by the GME director. This committee meets on average every month. ACGME requires at minimum one per quarter.

General Principles 1. Ultimate decisions regarding a House Officer’s continuation in a program lie with the CMO upon recommendation of the Program Director through the Graduate Medical Education Committee

2. As a general rule, House Officers accepted into multi-year programs will continue in those programs from year to year unless their performance has been unsatisfactory. House Officers enrolling in a multi-year program are expected to stay in that program until completion. The training program has no obligation to continue an unsatisfactory House Officer from year to year.

3. Program Directors who offer one-year programs have no obligation to offer training beyond this period to House Officers enrolled in such one-year programs.

4. Failure to continue House Officers from year to year after expiration of his/her contract will be in compliance with section F.

PROCEDURE

A. Ongoing Review 1. Each House Officer’s performance will be evaluated periodically (no less than semi- annually) by a faculty advisor or CCC. Records are kept of this evaluation and are submitted to GMEC by the PD.

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128/288 2. A verbal or written report should be given to the House Officer in the conclusion of each rotation regarding his performance.

3. Written evaluations are available for review by the House Officer.

4. Periodically, but no less than twice a year, the Program Director or designee will meet with each House Officer to discuss progress, deficiencies, and status in the program.

5. The Departmental CCC will regularly review the performance of each trainee in the program (no less than yearly). Records are kept of each review and are available for review by the House Officer.

B. Corrective Action 1. If deficiencies within the program are identified, the Program Director or designee will meet with the House Officer, discuss deficiencies, and formulate a plan for correction. A timetable of evaluation and reassessment will be formulated. The Departmental CCC will review the Resident’s progress in-depth at its next scheduled meeting.

If the performance deficiencies are refractory to initial corrective action, either a Letter of Concern and a Coaching Plan may be issued. This is presented to the House Officer at a meeting with the Program Director or designee where other members of the CCC and/or employee’s representative may be present. The House Officer may respond in writing to the concerns raised and this response will be placed in his/her record with a copy of the Letter of Concern/Coaching Plan. If deficiencies are remedied, the Letter of Concern/Coaching Plan are purged from the house officer’s record.

At the discretion of the PD or designee, a Structured Learning Plan may also be issued at the time of the Letter of Concern/Coaching Plan. Alternatively, a Structured Learning Plan may result if prior measures fail to resolve identified deficiencies upon re-review. In contrast to the Letter of Concern or Coaching Plan, a Structured Learning Plan is permanently retained in the House Officer’s record and reportable should an outside agency specifically inquire.

2. If the deficiencies are of a sufficient serious nature, or remain present after issuance of a Letter of Concern, a Coaching Plan and a Structured Learning Plan, further corrective actions may result; this may include, but are not limited to, restriction of activities, suspension, or termination from the program. A period of probation may be imposed by the Program Director with the concurrence of the Departmental CCC. Probation is permanently retained in the house officer’s file and reportable should an outside agency specifically inquire.

C. Probation 1. Probation may be Academic or Disciplinary: a. Academic probation may be imposed for substandard performance, as defined by the ACGME competencies b. Disciplinary probation may be imposed for inappropriate professional behavior or conduct, substance abuse or other failures to meet established professional standards of behavior.

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2. The House Officer shall be asked to meet with the Program Director or CCC members at the time probation is recommended. If Disciplinary Probation is recommended, a Union Representative and/or legal counsel may assist the House Officer. If Academic Probation is recommended, assistance by a Union Representative only is permitted. The House Officer will be given the reasons for this action, the conditions required, and an opportunity to respond to the concerns of the Department. a. The terms of Probation may include: i. The House Officer receives no “unsatisfactory” overall evaluations for rotations while on probation. ii. The trainee completes in a satisfactory manner, a remedial program formulated jointly by the Program Director, the House Officer, and the CCC designed to remedy identified deficiencies. iii. The House Officer on probation meets monthly with the Program Director or designee. iv. Psychological counseling may be required. v. Imposition of probation is not subject to appeal and shall be reported to the Graduate Medical Education Committee. Other forms of corrective action as described in Section B2 are subject to the hearing process in section D. vi. Duration of probation is contingent upon the House Officer’s success and progress in correcting identified deficiencies. At any time, the house officer may apply to the Department CCC for termination of probation. vii. Record of House Officer’s probation will become a permanent part of the House Staff Record. viii. The House Officer’s current preceptor shall be notified immediately by the Training Program Director of the imposition of probation. 3. The House Office shall be notified in writing by the Training Program Director upon successful completion of probation. If a House Officer on probation continues to receive unsatisfactory evaluations, fails to comply with the terms of probation or displays serious deficiencies that could endanger patients, the Training Program Director, with the concurrence of the CCC, may recommend further disciplinary action, up to and including dismissal of the House Officer from the training program, by the mechanism below: a. The Program Director convenes the CCC and presents the data justifying disciplinary action against the House Officer. b. The CCC by majority vote, based upon data presented, recommends disciplinary action to the program director. c. The Program Director informs the House Officer of the disciplinary recommendation, the reasons for such action, and the right to a hearing. The details of the hearing are to be discussed by the DIO. The House Officer may choose to waive the Hearing procedures by stating such action in writing to the DIO within 10 days of being informed of the recommendation. Such a waiver will state that the House Officer is willing to accept the proposed discipline that the acceptance is voluntary, and shall certify that the Program will be held blameless.

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130/288 d. If the House Officer chooses not to waive the Hearing procedure, the House Officer must request to the DIO, in writing, that he/she would like a hearing. This must occur within 10 days of being informed of the recommendation. The DIO requests the Graduate Medical Education Committee to convene a Hearing Panel to review the recommendation for discipline. This Hearing is to be held within 14 calendar days after request for hearing.

D. Hearing Procedures The Recommendation of the Hearing Panel will be transmitted to the CMO for appropriate action. 1. The Hearing Panel will consist of seven persons. The Designated Institutional Officer, two appointees from the Medical Staff chosen by its President, and two house staff members chosen by the House Staff Union will be voting members. The Chief Medical Officer and the Director of Human Resources will be non-voting members. None of the panel members will have been directly involved in the event or have any conflict of interest. The House Officer has the right to challenge one appointee without cause and request an alternate. The Designated Institutional Officer, or his/her designee, will be the Chairperson of the Hearing Panel, will determine the order of the procedure during the hearing, and will have the authority and discretion to make all rulings on questions, which pertain to the Hearing. If the DIO has personal involvement in the issues, he/she shall designate an alternate.

2. Rules applying at the Hearing: a. The House Officer shall have the right to call any witness to testify. b. The House Officer’s Program Director will be called as a witness to present data supporting the House Officer’s disciplinary action. The House Officer or the Program Director may present any evidence that either party believes is relevant, and the receipt or consideration of such evidence shall not be limited to that which is admissible in a court of law. Hearsay evidence, which may include the House Officer’s evaluations and record of performance, shall be allowed to be introduced as evidence by either party. c. Either party may be represented by legal counsel. Either party may choose a member of the house officer corps or Active Medical Staff to represent, advise, and assist them in the hearing. The House Officer may have a non-physician union representative participate during the proceedings. d. The recommendation of the Hearing panel to the CMO shall: i. Be determined by a majority vote. ii. Be based only upon the evidence presented at the Hearing. iii. Be in writing. e. A record of the hearing shall be maintained, either by means of handwritten notes, a tape recorder, or certified court reporter, the choice of method to be the hospital’s option. The House Officer may, at his/her own expense, arrange for a certified court reporter to additionally record the proceedings.

3. The Hearing Panel may recommend any modification of the Program Director’s recommendation, including a recommendation that no disciplinary action be imposed. The Hearing Panel shall specify what, if any, disciplinary recommendations are being made. The

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131/288 House Officer shall be furnished a copy of the recommendation of the Hearing Panel at the same time that it is forwarded to the CMO. He/she shall be given 14 calendar days in which to submit to the CMO a written response or argument in opposition to the Hearing Panel’s recommendation. The CMO shall review this response prior to making a final decision and taking action.

4. The CMO shall receive the recommendation of the Hearing Panel and review it to ensure the proper form has been followed. If the Director finds that the Hearing did not comply with established procedures, he/she may remand the case to the Graduate Medical Education Committee with the recommendation that a new Hearing Panel be formed to hear the case again.

5. The CMO will make the final decision as to the disciplinary action, and shall so notify the House Officer, in writing, within 14 calendar days of receiving the Hearing Panel’s recommendation.

6. No record of the hearing will be entered in the House Officer’s permanent record until such a time as the complete matter has been carried through to its conclusion.

E. Summary Suspension If, at any time, a Program Director has evidence that there is immediate danger to hospital personnel, patients, or the public by the continued functioning of a House Officer, the House Officer shall be immediately removed from patient care duties until the above process is concluded. The Program Director shall ensure that other personnel complete the House Officer’s patient care duties during the suspension period.

F. Failure to Renew a Contract In the event that a Program Director of a multi-year program chooses to not recommend renewal of a House Officer’s year-to-year contract, the following procedures shall apply: 1. The House Officer must be given written notice of intent not to renew their contract at least four months in advance of the expiration date.

2. If the primary reason for such non-renewal occurs within four months prior to the expiration of such an agreement, the Program Director shall give as much notice as the circumstances reasonably allow.

3. Failure to renew a House Officer’s year-to-year contract may be appealed by the process outlined in sections C-3 and D.

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132/288 APPROVALS

System Alameda AHS/Highland/John George/San Leandro Department Date: N/A 06/2020 06/2020 Pharmacy and Date: N/A N/A N/A Therapeutics (P&T) Clinical Practice Date: 06/2020 N/A N/A Council (CPC) Medical Executive Date: N/A 07/2020 07/2020 Committee Board of Trustees Date: N/A N/A

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HAZARD VULNERABILITY ANALYSIS – DIRECTIONS FOR USE

Department Environmental Health and Effective Date 09/2010 Safety Campus AHS System Date Revised 09/2010, 01/2019, 05/2020 Category Administrative Next Scheduled Review 08/2023 Document Director, Environmental Executive Responsible Chief Quality Officer Owner Health and Safety Printed copies are for reference only. Please refer to electronic copy for the latest version.

PROCEDURE 1. Locate the four (4) Hazard Vulnerability assessment tools that are labeled: Hazardous Materials, Human Related, Naturally Occurring and Technological Events.

2. The Environmental Health and Safety Manager will share the tool with the Environment of Care/Emergency Management Committee to review each tool and assess if the events need to be updated.

3. The Environment of Care/Emergency Management Committee will initiate the assessment by reviewing, discussing and comparing the events that have occurred at Alameda Health System (AHS), in the external community, across the state, across the nation and in the world.

4. When assessing each event on the tool use the severity indicators (Probability, Human Impact, Property Impact, Business Impact, Preparedness, Internal Response, External Response and Recovery) to rate the impact of the magnitude and mitigation effort.

5. Use a simple scale of 0 to 3 to rate the magnitude of the severity and mitigation effort as indicated in each of the columns. Each event will have a total score ranging from 7 being the lowest (no contingency plan needed) to a high of 21 (indicating that a contingency plan will be needed).

6. Once the assessment of all events has been conducted, the Hazard Vulnerability Analysis tool will be reviewed at each site by the Environment of Care/Emergency Management Committee to determine if the scores are aligned with community hazards. If changes are needed the site can use a separate tool to document their community events.

Explanation of the Indicators: Probability In the probability column, rate the likelihood of each event’s occurrence. Use a simple scale of 0 to 3, with 0 as the lowest probability, and 3 as the highest.

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134/288 Assess the Potential Human Impact: Analyze the potential human impact of each event; consider the potential for death or injury. Use a simple scale of 0 to 3, with 0 as the lowest probability, and 3 as the highest.

Assess the Potential Property Impact: Consider the potential property for losses and damages. Consider:  Cost to replace  Cost to set up temporary replacements  Cost to repair Use a simple scale of 0 to 3, with 0 as the lowest probability, and 3 as the highest.

Assess the Potential Business Impact on the Ability to Provide Services: Consider the potential impact on the hospital’s ability to provide services to patients. Assess the impact of:  Employees unable to report to work  Patients unable to reach the facility  Interruption of critical supplies  Impact on utility services supplying the hospital Use a simple scale of 0 to 3, with 0 as the lowest probability, and 3 as the highest.

Assess the Preparedness (Internal and External Responses): 1. Assess the hospital’s resources and ability to respond 2. Evaluate the type of emergency from beginning to end. Look at each resource that would be needed to respond. 3. For each emergency ask these questions: a. Do we have the needed resources and capabilities to respond? b. Will external resources be able to respond to us for this event as quickly as we may need them, or will they have other priorities areas to serve? If the answers are “yes” score them a 1. If no, score up to a 3. Use a simple scale of 1 to 3, with 3 as the lowest probability, and 1 as the highest.

Total the Columns: The lower the score, the less likely the events needs additional contingency plans. The higher the score, the higher the likelihood that you should have contingency plans designed to:  Define emergency procedures  Conduct additional staff training  Acquire additional equipment  Establish mutual aid arrangements and agreements  Establish agreements with specialized contractors, and other resources.

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135/288 APPROVALS

System Alameda AHS/Highland/John George/San Leandro Department Date: N/A 05/2020 05/2020 Pharmacy and Date: N/A N/A N/A Therapeutics (P&T) Clinical Practice Date: 05/2020 N/A N/A Council (CPC) Medical Executive Date: N/A 07/2020 07/2020 Committee Board of Trustees Date: N/A N/A

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HAZARD VULNERABILITY ANALYSIS

Department Environmental Health and Effective Date 01/2008 Safety Campus AHS System Date Revised 11/2007, 10/2011, 01/2019, 05/2020 Category Administrative Next Scheduled 08/2023 Review Document Director, Environmental Executive Responsible Chief Quality Officer Owner Health and Safety Printed copies are for reference only. Please refer to electronic copy for the latest version.

PURPOSE Alameda Health System (AHS) must be prepared for a variety of disasters or emergency situations both natural and man-made. In order to react to these disasters or emergencies, AHS shall prepare and plan for the responses and reactions required in these situations.

POLICY AHS shall annually perform a hazard vulnerability analysis in order to determine and identify the specific procedures required in response to a variety of disasters or emergency situations.

PROCEDURE AHS Environment of Care/Emergency Management Committees will annually perform a hazard vulnerability analysis to determine the types of disasters or emergency situations that have a high probability of occurring within the response areas of AHS.

AHS’s Environmental Health and Safety Manager will share the completed Hazard Vulnerability Analysis with the emergency management community for review and feedback.

AHS’s Environment of Care/Emergency Management Committee can reconvene for additional hazard analysis at anytime throughout the year when new hazards or situations have been discovered.

This analysis will be documented on the Hazard Vulnerability Analysis Tool. Each of the disasters or emergency situations will be listed on the tool and a score will be assigned. These scores will determine the probability of occurrence, human, business, and property impacts, internal, external and recovery responses. The numerical score of the hazard vulnerability analysis indicates the need for contingency planning and possible drill scenarios.

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137/288 REFERENCE The Joint Commission Comprehensive Accreditation Manual for Hospitals – EM.01.01.01

APPROVALS

System Alameda AHS/Highland/John George/San Leandro Department Date: N/A 05/2020 05/2020 Pharmacy and Date: N/A N/A N/A Therapeutics (P&T) Clinical Practice Date: 05/2020 N/A N/A Council (CPC) Medical Executive Date: N/A 07/2020 07/2020 Committee Board of Trustees Date: N/A N/A

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HEALTH CARE DECISION FOR INCAPACITATED UNREPRESENTED PATIENTS

Department Social Services Effective Date 08/2010 Campus AHS System Date Revised 08/2010, 01/2013, 04/2020 Category Clinical Next Scheduled 08/2023 Review Document Chief Medical Informatics Executive Responsible Chief Medical Officer Owner Officer Printed copies are for reference only. Please refer to electronic copy for the latest version.

PURPOSE This policy is designed to provide uniformity and consistency across AHS acute and post- acute system on the process for making ethically sound medical decisions for incapacitated unrepresented patients.

POLICY AHS will use an interdisciplinary team (IDT) with diverse perspectives to make ethical and effective medical decisions for incapacitated unrepresented patients.

BACKGROUND Despite their incapacity, unrepresented patients are entitled to ethical and effective medical decisions made on their behalf and in keeping with their best interests, taking into consideration patients’ personal histories, values, and beliefs to the extent that these are known. Use of an interdisciplinary team to make medical decisions is consistent with community standards of care.

Unrepresented means that despite efforts to locate an appropriate surrogate decision maker no one has been identified who knows the patient and is willing and able to make medical treatment decisions on his or her behalf. This document does not address the criteria for determining and appointing an appropriate decision maker when one or more are available and willing to serve. And finally, this procedure is not meant to be applied in emergency medical situations including those in which an altered state will likely clear within a few hours.

Decisions made without clear knowledge of an incapacitated unrepresented patient’s specific treatment preferences must be in the patient’s best interest, Decisions about treatment should be based on sound medical advice and should be made without influence of material conflicts of interest. These decisions must be made with a focus on the patient’s interests, beliefs and values, and not the interests, beliefs or values of providers, the institutions, or other affected parties. In this regard, appropriate health care decisions include both the provision of needed medical treatment, and the withholding or withdrawing of treatment that is medically ineffective or contrary to generally-accepted health care standards.²

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139/288 This policy applies to most medical decisions for which informed consent is usually required. This procedure is meant to support and supplement AHS’s underlying consent policy. Use of this policy does not preclude any party from seeking judicial intervention. Appropriate judicial remedies may include a timely court order authorizing the provision, withdrawing, or withholding of treatment or appointment of a conservator; however, courts are not necessarily the proper forum in which to make health care decisions.³

PROCEDURE Conditions for Invoking Policy This policy may be used when all of the following conditions are met: 1. The patient has been determined by the primary physician (with assistance from appropriate consulting physicians if necessary) to lack capacity to make health care decisions. Capacity means a patient’s ability to understand the nature and consequences of proposed health care, including its significant benefits, risks and alternatives, and to make and communicate a health care decision. Conditions for which psychiatric or psychological treatment may be required do not, in and of themselves, constitute a lack of capacity to make health care decisions.

2. No agent, conservator, or guardian has been designated to act on behalf of the patient.

3. There is no individual health care directive or instruction in the patient’s medical record or other available sources that would eliminate the need for a surrogate decision maker.

4. No surrogate decision maker can be located who is reasonably available4 and who is willing and able to serve. Efforts to locate a surrogate should be diligent and may include contacting the facility from which the patient was referred, and contacting public health or social service agencies known to have provided treatment for the patient. See Attachment I for steps to pursue in conducting a due diligent search for potential surrogate decision makers.

Requirement of Notification When Invoking Policy When the above conditions are met, the incapacitated unrepresented patient must be notified that: 1. He or she has been determined incapacitated;

2. It has been determined that he or she lacks a surrogate decision maker;

3. Medical decisions will be made by the IDT in accordance with this policy; and

4. He or she has the opportunity to seek judicial review of the above determinations.

Reliance on Interdisciplinary Team to Make Decisions Under This Policy When use of this policy is appropriate (as outlined above), medical decisions will be made by an ad-hoc interdisciplinary team whose members shall include, but not be limited to, individuals directly involved with care of the patient.

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140/288 Interdisciplinary Team Composition It is recommended that the interdisciplinary team include an attending physician, nurse familiar with the patient, social worker familiar with the patient, chair and/or member(s) of the ethics committee, non-medical (community) member of the ethics committee or other appropriate committee and, if available and appropriate, consulting clinicians, resident physician(s), Advance Practice Providers, and spiritual care staff.5

Interdisciplinary Team Responsibilities In order to determine the appropriate medical treatment for the patient, the interdisciplinary team should: 1. Review and confirm that a determination of incapacity has been made.

2. Review and confirm that the searches done prior to such conclusions have been diligently performed. The expected procedures can be found in Attachment I.

3. Review the diagnosis and prognosis of the patient as well as the treatment options and their associated risks, benefits, and alternatives.

4. Determine appropriate goals of care by weighing the following considerations: a. Patient’s previously-expressed wishes, if any and to the extent known b. Relief of suffering and pain c. Preservation or improvement function d. Recovery of cognitive functions e. Quality and extent of life sustained f. Degree of intrusiveness, risk or discomfort of treatment g. Cultural or religious beliefs, to the extent known

5. Establish a care plan based upon the patient’s diagnosis and prognosis and the determination of appropriate goals of care. The care plan should determine the appropriate level of care, including categories or types of procedures and treatments and code status, when appropriate.

Scope of Interdisciplinary Team Decision Making Authority Under the terms of this policy, the interdisciplinary team may make the same treatment decisions, and will have the same limitations, as does an agent appointed pursuant to a power of attorney for health care specified under current law6 7. However, this policy shall not apply to decisions pertaining to autopsies, anatomical gifts, or disposition of remains.

The interdisciplinary team must assure itself that the medical decision is made based on sound medical advice, and is in the best interest and takes into account the patient’s values, beliefs, and preferences to the extent known. In determining the best interest of the patient, it is not required that life support be continued in all circumstances, for example when treatment is otherwise non- beneficial or is medically ineffective or contrary to generally-accepted health care standards, when the patient is terminally ill and suffering, or when there is no reasonable expectation of the recovery of cognitive functions.

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141/288 Except to the extent that such a factor is medically relevant, any medical treatment decision made pursuant to this policy shall not be biased based on the patient’s age, sex, race, color, religion, ancestry, national origin, disability, marital status, sexual orientation (or any other category prohibited by law), the ability to pay for health care services, or avoidance of burden to family/others or to society.

Status of IDT Treatment Decisions Agreement on Treatment 1. If all members of the interdisciplinary team agree to the appropriateness of providing the proposed treatment, it shall be provided.

2. If all members of the interdisciplinary team agree to the appropriateness of withholding or withdrawing treatment, it shall be withdrawn or withheld. Any implementation of a decision to withhold or withdraw life-sustaining medical treatment will be the responsibility of the primary treating physician.8

Disagreement on Treatment 1. If the members of the interdisciplinary team disagree about the care plan, the ethics resources expert(s) or other resource experts will meet with the team to explore their disagreement and facilitate resolution.

2. If an agreement is still not reached, current treatments will be continued and any other medically necessary treatments provided, until such a time that the issue is resolved through court intervention or the disagreement is otherwise resolved.9 Court-imposed legal remedies should be sought only in extreme circumstances and as a last resort.3

In all cases, appropriate pain relief and other palliative care shall be continued.

Exceptional Circumstances Legal counsel should be consulted if a decision to withhold or withdraw treatment is likely to result in the death of the patient and the situation arises in any of the following circumstances: 1. The patient’s condition is the result of an injury that appears to have been inflicted by a criminal act.

2. The patient’s condition was created or aggravated by a medical accident.

3. The patient is pregnant.

4. The patient is a patient with sole custody or responsibility for support of a minor child.

Prerequisites for Convening an IDT Meeting 1. Assessment of incapacity clearly documented by attending physician in progress notes.

2. Confirmation has been made that there is no advance health care directive, conservator, guardian or other available decision maker, and no health care instructions in the patient’s medical record or other available sources.

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3. Due diligent search has been performed and patient’s unrepresented status confirmed.

4. Patient has been notified of incapacitated and unrepresented determination and right to seek judicial review.

5. Treatment question(s) for IDT to consider and the recommendation of the treating team have been clearly identified.

6. Identification of relevant clinical specialties has been made and their input sought.

7. Invite and ensure participation of the following at a minimum in the IDT meeting: an attending physician, nurse familiar with the patient, social worker familiar with the patient, chair and/or member(s) of the ethics committee, non-medical (community) member of the ethics committee or other appropriate committee and, if available and appropriate, consulting clinicians, resident physician(s), Advance Practice Providers, and spiritual care staff.

8. Invite and encourage participation of individuals identified in the due diligent search who may know or have information about the patient that might be valuable for the IDT even if they are not comfortable or willing to serve as surrogate decisions makers.

Documentation Signed, dated and timed medical record progress notes will be written for the following: 1. The findings used to conclude that the patient lacks medical decision-making capacity.

2. The finding that there is no advance health care directive, no conservator, guardian or other available decision maker, and no health care instructions in the patient’s medical record or other available sources.

3. The attempts made to locate surrogate decision makers and/or family members as part of the due diligent search and the results of those attempts.

4. Patient notification of incapacitated and unrepresented determination and right to seek judicial review.

5. Any treatment decisions the IDT has made specifically any plans to provide or withhold/withdraw proposed treatments and decisions regarding code status.

6. The basis for the IDT’s recommendation and decision to treat the patient and/or the recommendation and decision to withhold or withdraw treatment.

7. Any information from the ethics committee or other consults, should it be convened.

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143/288 ATTACHMENT I Procedure for Conducting Due Diligent Search as part of AHS Health Decisions for Incapacitated Unrepresented Patients Policy

These cases are often complex and challenging. The ethics committee is always available to offer assistance, guidance, and advice.

The purpose of the due diligent search is to:  Search for surrogate decision maker or members of patient’s support network  Gather evidence of patient’s values, beliefs, preferences, and any other relevant data

Procedure for social workers conducting the due diligent search: 1. The social worker will conduct a chart review to look for: a. any prior statements of wishes or documentation of treatment preferences b. any prior decisions made, c. any prior surrogate decision makers d. any prior advance directives. e. any record of the patient’s PCP and other involved care providers f. any record of agencies the patient may have once been a client of, skilled nursing facility in which they lived, homeless shelter or other provider of services they may have frequented. g. In all instances the due diligent search seeks to identify potential surrogate decision makers and/or information about the patient’s values, beliefs, preferences. To that end, when talking to potential surrogate decision makers or prior providers of care it is important to seek any information that might shed light on the patient’s values, goals, beliefs, preferences, priorities, and world view that could inform our care.

2. In an effort to identify appropriate surrogate decision makers the social worker will also: a. With the assistance of a witness (document who this is) search throughout the patient’s personal effects for any identifying information. b. Review phone numbers in the patient’s cell phone and make contact c. Review the reports by Ambulance EMT, and other emergency personnel. d. Search address on the internet to locate any phone numbers connected with address of ambulance pick up location e. Post a message on the wall of the patient’s room asking visitors to talk to the social work or nursing staff

3. If still unable to identify appropriate surrogate decision maker the social workers will. a. Seek assistance from local police to place a notice at the patient’s last known residence or to visit the location where the patient was found or most recently lived b. Search internet for phone numbers connected to the patient’s name c. Contact AHS Homeless teams, Urgent Care and K6 staff d. Contact the AHS’s Private Investigator e. Contact the California Advance Health Care Directive Registry by faxing a letter of inquiry to 916-651-9805

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144/288 4. If his or her identity is established but no advance directives or evidence of treatment preferences have been identified: a. Search the current and historical electronic health record for information regarding medical preferences b. Contact PCP and/or community providers if none found within AHS.

5. Once potential decision makers are identified consider using the following script to explain why you are speaking to them and how they can help a person in need. Ask for contact information for anyone they think may know the patient. Be sure to ask them what they know about the patient- anything from which we can glean information regarding the patient’s values and beliefs can be helpful:

6. When the person who can serve as the surrogate decision maker is identified: Explain to them what a surrogate does, and does not do. For example the surrogate does not exercise their personal beliefs or that of the family. They exercise their best understanding of what the patient would have wanted for themselves. Ask if potential surrogate decision makers are willing to make health decisions on the patient’s behalf. If not, do they know of anyone one else who might be suited for this role? If not are they willing to assist as an informant?

7. Even if no one we locate qualifies as an appropriate surrogate decision maker, by talking with them and/or members of the patient’s support network we can still learn more about what is important to the patient, their values, goals, beliefs, preferences, priorities, and world view.

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REFERENCES 1 This policy is intended for use in general acute care hospitals. California Health and Safety Code Section 1418.8 set forth a statutory decision-making process for patients in a skilled nursing facility or intermediate care facility.

2 California Probate Code Section 4735 states that: “A health care provider or health care institution may decline to comply with an individual health care instruction or health care decision that requires medically ineffective health care or health care contrary to generally accepted health care standards applicable to the health care provider or institution.”

3 California Probate Code Section 4650(c) states that: “In the absence of controversy, a court is normally not the proper forum in which to make health care decisions, including decisions regarding life-sustaining treatment.”

4 California Probate Code Section 4717 states that: a. Notwithstanding any other provision of law, within 24 hours of the arrival in the emergency department of a general acute care hospital of a patient who is unconscious or otherwise incapable, of communication, the hospital shall make reasonable efforts to contact the patient’s agent, surrogate, or a family member or other person the hospital reasonably believes has the authority to make health care decision on behalf of the patient. A hospital shall be deemed to have made reasonable efforts, and to have discharged its duty under this section, if it does all of the following: i. Examines personal effects, if any, accompanying the patient and any medical records regarding the patient in its possession and reviews any verbal or written report made by emergency medical technicians or the police, to identify the name of any agent, surrogate, or a family member or other person the hospital reasonably believes has the authority to make health care decisions on behalf of the of the patient. ii. Contacts or attempts to contact any agent, surrogate, or a family member or other person the hospital reasonably believes has the authority to make health care decisions on behalf of to the patient as identified in paragraph (1). iii. Contacts the Secretary of State directly or indirectly, including by voice mail or facsimile, to inquire whether the patient has registered an advanced health care directive with the Advance Health Care Directive Registry, if the hospital finds evidence of the patient’s Advance Health Care Directive Registry identification card either from the patient or the patient’s family or authorized agent. b. The hospital shall document in the patient’s medical record all efforts made to contact any agent, surrogate, or family member or other person the hospital reasonably believes has the authority to make health care decisions on behalf of the patient. c. Application of this section shall be suspended during any period in which the hospital implements its disaster and mass casualty program, or its fire and internal disaster program.

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146/288 California Probate Code Section 4736 states that: A health care provider or health care institution that declines to comply with an individual health care instruction or health care decision shall do the following: (a) Promptly inform the patient, if possible, and any person then authorized to make health care decisions for the patient. (b) Unless the patient or person then authorized to make health care decisions for the patient refuses assistance, immediately make all reasonable efforts to assist in the transfer of the patient to another health care provider or institution that is willing to comply with the instruction or decision. (c) Provide continuing care to the patient until a transfer can be accomplished or until it appears that a transfer cannot be accomplished. In all cases, appropriate pain relief and other palliative care shall be continued.

5 Institutions should designate by policy the particular types and numbers of providers who may constitute the multi-disciplinary team, and should ensure that non-medical/community representatives are properly prepared to serve on the

6 California Probate Code Section 4617 states that: ”Health care decision” means a decision made by a patient or the patient’s agent, conservator, or surrogate, regarding the patient’s health care, including the following: (a) Selection and discharge of health care providers and institutions. (b) Approval or disapproval of diagnostic tests, surgical procedures, and programs of medication. (c) Directions to provide, withhold, or withdraw artificial nutrition and hydration and all other forms of health care, including cardiopulmonary resuscitation. California Probate Code Section 4683 states that: “Subject to any limitations in the power of attorney for health care: (a) An agent designated in the power of attorney may make health care decisions for the principal to the same extent the principal could make health care decisions if the principal had the capacity to do so.”

7 California Probate Code Section 4652 states that: “This division does not authorize consent to any of the following on behalf of a patient: (a) Commitment to or placement in a mental health treatment facility. (b) Convulsive treatment (as defined in Section 5325 of the Welfare and Institutions Code). (c) Psychosurgery (as defined in Section 5325 of the Welfare and Institutions Code). (d) Sterilization. (e) Abortion.”

8 California Probate Code Section 4734 states that: a. A health care provider may decline to comply with an individual health care instruction or health care decision for reasons of conscience. b. A health care institution may decline to comply with an individual health care instruction or health care decision if the instruction or decision is contrary to a policy of the institution that is expressly based on reasons of conscience and if the policy was timely communicated to the patient or to a person then authorized to make health care decisions for the patient.

9 California Probate Code Section 4736 states that: A health care provider or health care institution that declines to comply with an individual health care instruction or health care decision shall do all of the following: (a) Promptly so inform the patient, if possible, and any person then authorized to make health care decisions for the patient. (b) Unless the patient or person then authorized to make health care decisions for the patient

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147/288 refuses assistance, immediately make all reasonable efforts to assist in the transfer of the patient to another health care provider or institution that is willing to comply with the instruction or decision. (c) Provide continuing care to the patient until a transfer can be accomplished or until it appears that a transfer cannot be accomplished. In all cases, appropriate pain relief and other palliative care shall be continued.

APPROVALS

System Alameda AHS/Highland/John George/San Leandro Department Date: N/A 04/2020 04/2020 Pharmacy and Date: N/A N/A N/A Therapeutics (P&T) Clinical Practice Date: 07/2020 N/A N/A Council (CPC) Medical Executive Date: N/A 07/2020 07/2020 Committee (MEC) Board of Trustees Date: N/A N/A

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HR: SECTION 1.00 -POLICY 1.12 EMPLOYMENT PROCESS

Department Talent Management Effective Date 12/1996 Campus AHS System Date Revised 04/24/2020 Category Human Resources Next Scheduled 08/2023 Review Document Manager, Talent Executive Chief Human Resource Owner Acquisition Responsible Officer Printed copies are for reference only. Please refer to electronic copy for the latest version.

PURPOSE To state fundamental policies governing the employment process.

POLICY Alameda Health System (AHS) is an Equal Opportunity Employer and is committed to non-discrimination in employment. AHS reaffirms its policy and well established practice of recruitment, hiring, and promotion in all job classifications without the unlawful discrimination on the basis of race, color, national origin, ancestry, age, sex, marital status, sexual orientation, religion, disability, veteran status, family care status or medical condition as defined by law or any other criteria prohibited by applicable federal, state or local law or ordinance. Consistent with this policy and the relevant MOU, all decisions on employment and promotions are made solely on the individual’s qualifications, and bona fide occupational qualifications for the job in question. Selection procedures will be conducted in compliance with applicable federal, state and local employment laws.

PROCEDURE 1. Position Requisition. This form is to be completed electronically when the department manager intends to fill a position. In addition to the job requisition the hiring supervisor must submit job-related criteria upon which to evaluate candidates. The job-related criteria must include relevant knowledge, skills and abilities and objective characteristics potential employees should possess for consideration for hire.

2. Posting Job Openings. The job opening will be posted electronically except as otherwise indicated by MOU for a minimum of seven (7) calendar days for represented positions. The CHRO or designee can make exceptions in certain circumstances for unrepresented positions

3. Employment Applications. The employment application is designed to obtain relevant information from all applicants in a standardized format to ensure valid hiring decisions

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and comparisons among candidates. This supports our goal of selecting the best qualified candidate for each opening and is in keeping with our equal employment opportunity policy. The Human Resources Department retains all applications for employment for three years. If applications are received by the Hiring Manager outside of the Human Resources Department, such applications must be forwarded to the Human Resources Department, whether or not the applicant is selected to be interviewed or hired. The Human Resources Department will send applicants a communication acknowledging receipt of their application or resume and informing them of AHS’ hiring procedures.

4. Transfers. Regular employees who have satisfactorily completed probation in their current position may apply for a transfer to open positions. To be considered, employees must complete the Employee Transfer Request and submit it electronically to the Human Resources Department. It is the policy of AHS to advertise for, attract and consider all qualified internal candidates. The prior sentence is subject to the provisos that 1) the bidding employee must meet all reasonable qualifications of the job established by AHS; 2) the applicant employee is in good standing; and 3) where an employee is applying for a different classification, ability and performance must be approximately equal. See relevant MOUs concerning seniority preferences.

5. External Job Applicants. All applications and resumes must be submitted electronically to the Human Resources Department

6. Reference Checks. Reference checks may be completed prior to or after an offer of employment. The hiring manager or Human Resources Department will conduct an investigation to verify the information provided on the employment application. If the investigation reveals that the applicant/employee has misrepresented information with regard to his/her education, degree(s) obtained, licensure, employment history or criminal record on the employment application, the application will be rejected. If the individual has already been hired, termination of employment may occur. The investigative report will be confidential. Any disclosure of information to affected department managers will occur only in the event of a termination. Background checks of current employees may be conducted at any time for reasonable cause.

7. Selection. The department manager makes the hiring decision in conjunction with Human Resources. a) The Human Resources Department will screen all applications to refer the best qualified applicants for the position. b) The hiring manager/supervisor will conduct the interviews and will determine the applicant’s ability to perform the requirements of the job, and who best meets the needs of AHS. The hiring manager will discuss the selection and appropriate salary level with the Human Resources Department prior to the verbal offer.

8. Offers of Employment. Human Resources will extend the employment offer with an offer letter to the potential employee and a copy to the hiring manager. All employment offers are contingent upon medical clearances, licensure, credentials, background check including verification of education and degrees, criminal background checks, substance

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abuse screen and other appropriate certifications of qualifications.

9. Medical Clearance. Applicants who accept employment offers must successfully complete a pre-placement physical examination. Pre-placement physical examinations will be scheduled only by the Human Resources Department.

10. On-Boarding. Newly hired employees are required to fill out employment papers in Human Resources prior to starting work.

11. New Employee Orientation. All new employees are required to attend the general orientation program provided by AHS by arrangement with their department manager within the first thirty (30) days of hire.

APPROVALS

System Alameda AHS/Highland/John George/San Leandro Department Date: N/A 04/2020 04/2020 Pharmacy and Date: N/A N/A N/A Therapeutics (P&T) Clinical Practice Date: 05/2020 N/A N/A Council (CPC) Medical Executive Date: N/A 05/2020 05/2020 Committee (MEC) Board of Trustees Date: N/A N/A

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KAISER OAKLAND/HIGHLAND OB/GYN RESIDENCY AHS COMMUNITY HOSPITALS

Department All Effective Date 10/2019 Campus AHS System Date Revised 6/2019, 05/2020 Category Clinical Next Scheduled 08/2023 Review Document Chair, Maternal Child Executive Associate Chief Medical Owner Health Responsible Officer, Chief Medical Officer Printed copies are for reference only. Please refer to electronic copy for the latest version.

PURPOSE To define the parameters of the professional graduate education program provided through the Kaiser Oakland sponsored Highland Site OB/GYN residency program, and the accompanying patient care activities that occur during the rotations at Highland Hospital, San Leandro Hospital and Alameda Hospital.

SCOPE To describe the roles, responsibilities, and patient care activities of the participants of the graduate education program. This policy applies to all stakeholders affected by the Kaiser Oakland Highland OB/GYN residency program at Highland hospital, San Leandro Hospital and Alameda Hospital.

The Kaiser Oakland Highland OB/GYN program maintains the same governance structure, including program director, at all affiliated clinical sites within Alameda Health System. The scope of this policy does not include the governance structure, or the program rules that apply to all trainees, at all AHS clinical sites.

DEFINITIONS A. Attending: Highland OB/GYN faculty members, who are licensed independent practitioners with appropriate clinical privileges at the facility

B. Trainees: Resident physicians working under the supervision of the Attending

C. Direct Supervision: the supervising physician is physically present with the trainee and patient.

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152/288 POLICY 1. Participants of the program will adhere to all facility policies.

2. The Attending is the initial contact, and ongoing primary contact, for all patient care provided by this service.

3. Attendings are the only individuals that may supervise the trainees.

4. All patient care performed by the trainee will occur under direct supervisionof the attending. a. Within the parameters of this policy, the supervising Attending makes the decision about each Trainee’s progressive involvement in specific patient care activities.

5. Attendings and Trainees must inform each patient of their respective roles in that patient’s care, when providing direct patient care.

6. Trainees will be PGY2, PGY3 or PGY4 level.

7. Trainees will be on-site as needed only. a. The Attending will initiate contact with trainee when services are needed in the operating room or perioperatively.

8. All trainee entries into the medical record must be signed with the inclusion of the trainee’s level. ( i.e.: PGY2, PGY3 or PGY4).

9. All trainee patient care orders, or other entries in the patient’s medical record, must be co- signed by the Attending before considered actionable.

REFERENCES 1. Affiliation Agreement Between the Kaiser Oakland and Alameda County Medical Center

2. Joint Commission Standard MS.04.01.01 – GRADUATE MEDICAL EDUCATION PROGRAMS

3. ACGME Common Program Requirements

4. ACGME OB/GYN Program Requirements

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153/288 APPROVALS

System Alameda AHS/Highland/John George/San Leandro Department Date: N/A 05/2020 05/2020 Pharmacy and Date: N/A N/A N/A Therapeutics (P&T) Clinical Practice Date: 05/2020 N/A N/A Council (CPC) Medical Executive Date: N/A 05/2020 05/2020 Committee (MEC) Board of Trustees Date: N/A N/A

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MAINTAIN, EXPAND, DECREASE, OR CLOSE SERVICES

Department Environmental Health and Effective Date 09/2011 Safety Campus AHS System Date Revised 04/2011, 04/2014, 01/2019, 04/2020 Category Administrative Next Scheduled Review 08/2023 Document Director, Environmental Executive Responsible Chief Quality Officer Owner Health and Safety Printed copies are for reference only. Please refer to electronic copy for the latest version.

PURPOSE This policy is intended to support business continuity and the Emergency Operations Plan by assessing the impact on essential services before, during and after a disaster.

POLICY The policy addresses the process the organization will take when circumstances arise from an emergency that create a burden on essential services.

PROCEDURE 1. When the Incident Commander is notified of compromising circumstances where a decision has to be made to maintain, expand, decrease, or close services he/she will call for briefing a with the Medical Care Branch Director and Operations Chief to assess the circumstances.

2. Careful consideration will be given to the decision making process to determine the impact to patient, staff, and visitor safety. Assessment will be made regarding the environmental safety conditions, determination regarding the continuation of essential services, assessment of availability of community resources, and local assets.

3. The decision to maintain, expand or decrease services will be made based on the need to provide the essential care and services that are required to support the emergency.

4. The Incident Commander will make the final decision regarding maintaining, expanding, or decreasing essential services. This decision will be communicated via the Incident Action Plan to the leaders in the organization and a mass communication will be sent to all staff.

5. A record of all decisions will be documented on the proper Hospital Command Center forms.

6. This decision may affect the community’s ability to sustain medical and health operations, therefore AHS’s final decision will be communicated to local emergency operation centers by the Liaison Officer (via the appropriate Hospital Command Center documents) by email or a phone call. The regulatory agencies having license and certification authority will be notified

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155/288 immediately by a phone call, fax or email of the final decisions regarding maintaining, expanding, decreasing or closing essential services.

APPROVALS

System Alameda AHS/Highland/John George/San Leandro Department Date: N/A 04/2020 04/2020 Pharmacy and Date: N/A N/A N/A Therapeutics (P&T) Clinical Practice Date: 05/2020 N/A N/A Council (CPC) Medical Executive Date: N/A 07/2020 07/2020 Committee Board of Trustees Date: N/A N/A

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MEDICAL RECORD FORMS: REQUIREMENTS AND APPROVAL PROCESS

Department Health and Information Effective Date 07/2013 Services Campus AHS System Date Revised 05/2020 Category Administrative; Health Next Scheduled 9/2023 Information Management Review Document Owner Director, Health Executive Chief Financial Information Management Responsible Officer Printed copies are for reference only. Please refer to electronic copy for the latest version.

PURPOSE To establish and implement procedures for the drafting, approval, issuance, revision, amendment, and control of all clinical forms to prevent duplication of existing forms, promote cost containment and standardization, and advise form development as needed.

POLICY The Health Information Management Committee will use the criteria and process outlined in this policy to govern the drafting, approval, issuance, revision, amendment, and control of all clinical forms.

PROCEDURE Clinical Form Standards Whenever possible, clinical forms at AHS will contain and adhere to the following standards: a. Form title b. Standardized form number, assigned by the HIM department c. Revision date d. Approved AHS logo e. Locations for patient identification and barcode are consistent with the current AHS form template f. Clinical for contents meet applicable Federal and State regulations as well as, Joint Commission and Core Measure standards g. Abbreviations are avoided h. Signature lines - All forms containing a signature line will provide adequate space for the care provider’s signature, date, and time. i. Paper size - Standard 8 ½” x 11” paper will be used whenever possible. Forms that fold open and are greater than 8 ½” x 11” must have a page break within the fold of the document. j. Font – 12-point Arial font is recommended.

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157/288 Health Information Management Committee 1. The Health Information Management (HIM) Committee’s responsibility is to review requests for additions, deletions or changes to clinical forms. New and existing clinical forms are reviewed by the committee for standardization, improvement or elimination.

2. Form requests must be reviewed and approved by the HIM Committee. Consents and Order Sets are routed to their approving committees and then to the HIM department for barcoding and formatting.

3. The Director of Health Information Management co-chairs the (HIM) Committee.

4. The HIM Committee is an interdisciplinary committee of the Medical Staff. Membership shall include representation from the following areas; a. Nursing e. Safety and Risk Manager/Representative b. Health Information Management f. Quality Manager/Representative c. Information Technology g. Chief Medical Information Officer d. Pharmacy h. AD hoc members

5. The HIM Committee will meet at least four times per year

Form Approval/Change Process 1. The department or “form business owner” requesting the creation of a new form or changes to an existing form must submit their request, in writing, to the Director of Health Information Management.

2. Form requests must be received at least two weeks prior to the HIM committee meeting date for inclusion on the HIM Committee agenda.

3. The forms business owner is responsible for obtaining any additional required committee approvals and sign offs prior to prior to their presentation for review by the HIM Committee.

4. Order Sets and Consent forms are routed directly to their approving committees and then to the HIM department for barcoding and formatting. a. Order Sets are approved by Pharmacy & Therapeutics (P&T) Committee b. Consent forms are reviewed and approved by members of the AHS Risk and Compliance team.

5. The form business owner is required to present a draft of the proposed form or changes for committee review and approval that adheres to established AHS form standards (listed above).

6. The HIM Committee will review all presented forms and move to either approve the form as is or make recommendations for change. a. When changes are recommended by the committee, the form business owner will make the necessary revisions and resubmit the revised version electronically to the Director of Health Information Management.

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7. Once a form is approved, it will be assigned a standardized form number by the HIM department.

8. The final approved draft will be sent to the forms vendor for reproduction.

9. The forms vendor will notify the Director of Health Information Management when the final form is generated. HIM will communicate this to the form business owner.

10. The HIM department will upload approved forms to Forms on Demand (FOD) for system- wide access.

11. The HIM department is responsible for maintaining records of the following: a. Barcoded, hard copy and final electronic version of all forms b. Correspondence/special instructions from the form business owner regarding the form c. All versions of revised forms d. Legal Health Record form inventory including a spreadsheet of all barcoded forms available for ordering or electronic access in Forms on Demand

12. The form business owner reviews and updates any associated policies or procedures impacted by the implementation of the new or revised form.

13. Prior to form distribution, the form business owner is responsible for contacting the Education department and coordinating inservices for form end-users.

14. Departments will order forms as needed according to ordering procedures established with the form vendor.

APPROVALS

System Alameda AHS/Highland/John George/San Leandro Department Date: N/A 05/2020 05/2020 Pharmacy and Date: N/A N/A N/A Therapeutics (P&T) Clinical Practice Date: 08/2020 N/A N/A Council (CPC) Medical Executive Date: N/A 08/2020 08/2020 Committee Board of Trustees Date: N/A N/A

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MEDICATION ADMINISTRATION: CHEMOTHERAPY ANTIDOTES FOR EXTRAVASATION MANAGEMENT

Department Pharmacy, Medical Staff Effective Date 08/2010 Campus AHS System Date Revised 05/2019, 06/2020 Category Clinical Next Scheduled 08/2023 Review Document Owner Hematology/Oncology Executive System Director of Pharmacy; Clinical Pharmacy Responsible Chief Administrative Officer/Chief Nurse Specialist Executive; Associate Chief Medical Officer Printed copies are for reference only. Please refer to electronic copy for the latest version.

PURPOSE To provide guidance in identifying the class of intravenously administered cytotoxic agents according to their adverse event potential. In addition, this policy is to guide initiating the appropriate management in order to minimize tissue damage at the extravasation site, based on evidence and best practices.

Note: The guideline is not a substitute for clinical judgment.

POLICY In the event that an extravasation of a cytotoxic agent occurs, timely and appropriate management should be acted upon in order to minimize tissue damage at the extravasation site.

DEFINITIONS 1. Extravasation: An antineoplastic cytotoxic drug that infiltrates into the surrounding tissues during intravenous administration. Particular drugs may cause extensive necrosis and the damage can continue for several weeks or months after the infusion.

2. Intravenous chemotherapy agents are classified into 5 categories according to their damage potential for extravasation a. Vesicants: Drugs that can cause tissue necrosis and blister formation if the drug extends into the tissue surrounding the vein. i. Non-DNA binding vesicants: when extravasated, these agents are inactivated or quickly metabolized and resume the normal healing process. ii. DNA binding vesicants: remain in the tissues resulting in long-term or more severe injury. b. Exfoliants: Drugs of low vesicant potential, as much injury are

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160/288 determined to be superficial. Extravasation may present as blistering, inflammation and skin shedding without tissue death. c. Irritants: Drugs that can cause inflammation, irritation, and pain at the site of extravasation. Patients often complain of a “burning sensation” in the vein during infusion. d. Inflammitants: Drugs that can cause mild to moderate inflammation and painless erythema. e. Neutrals: Drugs that do not cause inflammation or damage upon extravasation.

Revised 5/19

161/288 COMMON REACTIONS & ASSOCIATED DRUGS1

Vesicants Exfoliants Irritants Inflammitants Neutrals (Tissue necrosis & (Blistering, (Inflammation, (Inflammation, (No inflammation/ blister formation) inflammation, & skin pain, or painless skin damage) shedding irritation) erythema, & flares)

DNA Dactinomy Cisplatin Bendamusti 5-Fluorouracil Asparaginase cin ne Daunorubic Docetaxel Bleomycin Methotrexate Bevacizumab BINDING in Doxorubici Liposomal Carboplatin Bleomycin n Daunorubicin Epirubicin Liposomal Etoposide Bortezomib

Doxorubicin Idarubicin Mitoxantrone Topotecan Cetuximab Mitomycin Oxaliplatin Cyclophosphamide BINDING NON Paclitaxel Cytarabine Vinblastine Eribulin

- DNA Vincristine Fludarabine Vinorelbine Gemcitabine

Ifosfamide Melphalan Rituximab Trastuzumab Note: These are common antineoplastic agents, NOT an all inclusive list

Revised 5/19

162/288 SIGNS AND SYMPTOMS ASSOCIATED WITH EXTRAVASATION AND VENOUS IRRITATION

Extravasati on Assessme Immediate Delayed Spasm/Irritation of nt Manifestations of Manifestations the Vein Paramet Extravasation of er Extravasati on Pain Severe pain or burning that Up to 48 hours after Aching and tightness lasts minutes or hours infusion along the vein eventually subsides; usually occurs while the drug is being given around the needle site Redness Blotchy redness May intensify over time Vein may be around the needle site; reddened or darkened it is not always present at the time of extravasation Ulceration Develops insidiously; Late occurrence Not likely usually occurs 48-96 hours later Swelling Severe swelling; Up to 48 hours after Not likely usually occurs infusion immediately Bloo Inability to obtain blood N/A Blood return usually d return present retur n Other Change in the Local tingling Possibility quality of infusion and sensory resistance felt in deficits injection 4 Modified from Avon, Somerset, and Wiltshire NHS Cancer Services Policy

Revised 5/19

163/288 PROCEDURE 1. Extravastion involving a PERIPHERAL LINE: At the first sign of infiltration: a. Stop injection/infusion immediately. b. Disconnect the IV tubing from the IV device, but leave the needle/catheter in place. c. With a 1-3 mL syringe, slowly aspirate as much of the residual drug as possibleDo not apply pressure to the area. d. Remove IV access. Do not use this site for IV access any longer e. Assess the site of the suspected extravastation. Observe region for pain, induration or necrosis, and assess symptoms reported by the patient (e.g. pain, impairment of range of motion) f. Notify the physician. g. Initiate substance-specific (antidote) measures as shown in Appendix A, if applicable, h. Document all procedures. i. Provide patient education i. Continue warm or cold therapy for 24 to 48 hours ii. Elevate area for 48 hours to minimize swelling iii. Resume activity with affected limb as tolerated j. Consider surgical evaluation and wound consult for persistent or worsening symptoms

2. Extravasation involving a CENTRAL LINE: If the patient report changes in sensation, pain, burning, or swelling at the central venous catheter (CVC) site or in the ipsilateral chest, if a change occurs, or if no blood returns: a. Stop chemotherapy and IV fluids. Do not remove the cannula. b. If the patient has an implanted port, assess the site for proper needle placement. c. If extravasation is a result of needle dislodgement in a port, leave the needle in place and attempt to aspirate the residual drug d. If possible, aspirate the residual from the area of suspected infiltrate at the port pocket or at the exit site of the tunneled or percutaneous catheter. Do not apply pressure to the area. e. If aspiration is unsuccessful, remove the needle from the port and attempt to aspirate the drug subcutaneously, from the pocket and surrounding tissue. f. Assess the site of the suspected extravastation. Observe region for pain, induration or necrosis, and assess symptoms reported by the patient (e.g. pain, impairment of range of motion) g. Notify the physician h. Initiate substance-specific (antidote) measures as shown in Appendix A, if applicable i. If the patient has an implanted port, remove the port needle after instilling the antidote. Inject the antidote into subcutaneous tissue as appropriate j. Document all procedures.

Revised 5/19

164/288 k. Provide patient education. i. Continue warm or cold therapy for 24 to 48 hours l. Collaborate with the physician regarding i. The need for a radiographic flow study to determine the cause of extravasation ii. Future plans for IV access and patient management 3. Extravasation Kit (Appendix B) a. To be available in areas where cytotoxic chemotherapy drugs are administered routine

Revised 5/19

165/288 APPENDIX A: TABLE OF APPROVED SUBSTANCE-SPECIFIC MEASURES/ANTIDOTES FOR EXTRAVASATION MANAGEMENT DRU ANTID ICE/HEAT G OTE Anthracycline Agents ICE compress for 15-  Daunorubic Dexrazoxane (Totect): 20 minutes at least four in Dose to be given for 3 consecutive days. times a day for 24 to 2 (Cerubidine Day 1: 1000mg/m IV (max dose: 2000mg) 48 hours ) (Day 1 dose should be initiated as soon as possible and  Doxorubici within 6 hours after extravasion) 2 n Day 2: 1000mg/m IV (max dose: 2 (Adriamycin 2000mg) Day 3: 500mg/m IV (max Do not ice 15 ) daily dose: 1000mg) minutes before  Epirubicin **reduce dose by 50% if Crcl <40 and after (Ellence ) ml/min Mixing & Final Dilution dexrazoxane  Idarubicin  Mix each vial with provided 50ml diluent administration. (Idamycin o final [ ] = 10mg/ml ) o use within 2 hours  Withdraw needed dose and further dilute into infusion bag containing 1000ml of NaCl (use within 4 hours) Infusion  Infuse over 1-2 hours in large vein remote from site of extravasation  Remove ice packs from extravasation site 15 minutes before dexrazoxane administration to allow adequate blood flow to site  Day 2 & 3 should start at the same hours (+3 hours) as Day 1  Do not use with DMSO

Dimethyl Sulfoxide (DMSO) (Rimso-50 )  Using a sterile gauze pad, apply 1.5mL topically to cover twice the size of infiltration.  Begin within 10 minutes of extravasation  Apply every 8 hours for 7 days  Allow to air dry. Do not cover with dressing  Do not use with Dexrazoxane *for peripheral line extravasation IF dexrazoxane unavailable OR cannot be started within 6 hours* Bendamustine Sodium Thiosulfate: ICE compress for 15- (Bendeka ,  Prepare 1/6 molar solution: Mix 1.6 mL of 20 minutes at least four Treanda ) 25% sodium thiosulfate with 8.4 mL sterile times a day for 6-12 water for injection. hours following  Inject 2 ml subcutaneously into site for sodium thiosulfate each mg of bendamustine extravasated  Use 25-gauge or smaller needle  Change needed with each injection

Revised 5/19

166/288 Daunorubicin, None recommended ICE compress for 15- Liposomal 20 minutes at least four (DaunoXome ) times a day for 24 Doxorubicin, hours Liposomal (Doxil ) Cisplatin (Platinol ) Sodium Thiosulfate: ICE compress for 15- (> 20 mL and conc.  Prepare 1/6 molar solution: Mix 1.6 mL of 20 minutes at least four 0.5 mg/mL) 25% sodium thiosulfate with 8.4 mL sterile times a day for 6-12 water for injection. hours following  Inject 2 ml into site for each 100 mg cisplatin sodium thiosulfate extravasated through an existing IV line.  Then 1 ml (as multiple 0.1 ml injections clockwise around the area of extravasation) subcutaneously into extravasation site. Use 25-gauge or smaller needle  Subcutaneous injections can be repeated several times over the next 3 to 4 hours. Etoposide None recommended WARM compresses (VePesid )(VP- 16) for 15- 20 minutes at least four times a day Mechlorethamine Sodium Thiosulfate: ICE compress for 15- (Mustargen )(Nitrogen  Prepare 1/6 molar solution: Mix 1.6 mL of 20 minutes at least four Mustard) 25% sodium thiosulfate with 8.4 mL sterile times a day for 6-12 water for injection. hours following  Inject 2 ml subcutaneously into site for sodium thiosulfate each mg of mechlorethamine extravasated  Use 25-gauge or smaller needle  Change needed with each injection Mitomycin Dimethyl Sulfoxide (DMSO) (Rimso-50 ) ICE compress for 15- C  Using a sterile gauze pad, apply 1.5mL 20 minutes at least four (Mutamycin topically to cover twice the size of infiltration. times a day for 24-48 )  Begin within 10 minutes of extravasation hours  Apply every 8 hours for 7 days  Allow to air dry. Do not cover with dressing Oxaliplatin (Eloxatin ) None recommended WARM compresses for 15- 20 minutes at May consider for extravastion > 40 mg: least four times a day Dexamethasone 8mg orally BID for up to 14 days Taxane Agents No known antidotes or treatments ICE compress for 15-  Docetaxel (Taxotere) 20 minutes at least four  Paclitaxel (Taxol) May Consider: times a day Hyaluronidase (Amphadase ):  Inject subcutaneously into the extravasation site using a 25- gauge needle or smaller.  Dosage: 150 units (1 mL) given as five 0.2 mL injections into the extravasation site at the leading edge Change the needle after each injection. Revised 5/19

167/288 Vinca Alkaloids Hyaluronidase (Amphadase ): WARM compresses  Vinblastine  Inject subcutaneously into the extravasation site for 15- 20 minutes at (Velban ) using a 25- gauge needle or smaller. least four times a day  Vincristine  Dosage: 150 units (1 mL) given as five 0.2 mL (Oncovin ) injections into the extravasation site at the leading  Vinorelbin edge e  Change the needle after each injection. (Navelbine ) All other cytotoxic None Recommended ICE compress for 15-20 drugs minutes at least four times a day for 24-48 hours

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168/288 APPENDIX B: CHEMOTHERAPY/BIOTHERAPY EXTRAVASATION KIT CONTENT LIST

Unit/Floor/Clinic

Chemotherapy/Biotherapy Extravation Kit

Quantity Medication Expiration Date 1 Sodium Thiosulfate 25% (12.5gm/50mL) 1 Hyaluronidase 150 units/1ml vial **stored in fridge** 1 Topical DMSO 50% - 50 ml vial 2 Dexrazoxane 500mg vial (Highland Campus Only) 2 Sterile water 50mL (Highland Campus Only)

EXPIRATION DATE:

CHECKED BY:

DATE:

(Pharmacist)

Revised 5/19

169/288 REFERENCES 1. Kreidieh F. Overview, prevention and management of chemotherapy extravasation. World Journal of Clinical Oncology. 2016;7(1):87. doi:10.5306/wjco.v7.i1.87.

2. Schulmeister L. Vesicant Chemotherapy Extravasation Antidotes and Treatments. Clinical Journal Of Oncology Nursing[serial online]. August 2009;13(4):395- 398. Available from: Academic Search Complete, Ipswich, MA. Accessed June 18, 2017.

3. Chemotherapy extravasation guideline. West of Scotland Cancer Advisory Network Clinical Leads Group. 2009. Available at: http://www.beatson.scot.nhs.uk/content/mediaassets/doc/Extravasation%20guidance.pdf. Accessed June 16, 2017.

4. ASWCS Policy for the Treatment of Extravasation Injury. Avon Somerset & Wiltshire NHS. 2012. Available at: http://www.avon.nhs.uk/aswcs- chemo/NetworkPolicies/Extravasation%20policy_Final_19July2012.pdf. Accessed June 10, 2017.

5. Extravasation guidelines 2007: Guidelines Implementation Toolkit. EONS Clinical Guidelines. 2007. Available at: http://www.cancernurse.eu/documents/EONSClinicalGuidelinesSection6-en.pdf. Accessed June 16, 2017.

6. Guidelines on treatment of extravasation with cytotoxic drugs. European Oncology Nurses Society & Thames Valley Cancer Network. 2014. Available at: http://tvscn.nhs.uk/wp- content/uploads/2014/09/Extravastation-guidelines-3.0-December-2014-.pdf. Accessed June 16, 2017.

7. Polovich M, Olsen M, LeFebvre KB. Chemotherapy and Biotherapy Guidelines and Recommendations for Practice. 2014.

8. Perez Fidalgo J, Garcia Fabregat L, Cervantes A, Margulies A, Vidall C, Roila F. Management of chemotherapy extravasation: ESMO-EONS Clinical Practice Guidelines. Annals of Oncology. 2012;23(suppl 7):vii167-vii173. doi:10.1093/annonc/mds294.

9. Goolsby T, Lombardo F. Extravasation of Chemotherapeutic Agents: Prevention and Treatment. Seminars in Oncology. 2006;33(1):139-143. doi:10.1053/j.seminoncol.2005.11.007.

10. Mitsuma A, Sawaki M, Shibata T, et al. Extravasation of pegylated-liposomal doxorubicin: favorable outcome after immediate subcutaneous administration of corticosteroids. Nagoya J Med Sci. 2012;74(1-2):189-92.

11. Doellman D, Hadaway L, Bowe-geddes LA, et al. Infiltration and extravasation: update on prevention and management. J Infus Nurs. 2009;32(4):203-11.

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170/288 12. GUIDE TO EXTRAVASATION MANAGEMENT IN ADULT & PEDIATRIC PATIENTS. University of Kansas Hospital. 2009.

13. Gonzalez, Tulia,R.N., O.C.N. (2013). Chemotherapy extravasations: Prevention, identification, management, and documentation. Clinical Journal of Oncology Nursing, 17(1), 61-6.

14. Surrey, West Sussex and Hampshire. Guidelines for prevention and management of chemotherapy extravasation. Cancer Network. 2009 via https://bibliomed.bib.uniud.it/links/c-l-infermieristica/calcolo-applicato-alla-terapia- famacologica/swsh_network_chemotherapy_extravasation_guidelines_1.09.pdf

15. Kretzchmar, A, Pink D, Thuss-Patience P, et Al. “Extravasations of Oxaliplatin” . J Clin Oncol 2003; 21:4068

16. D. Larson "What is the Appropriate Management of Tissue Extravasation by Antitumor Agents? Plastic and Reconstructive Surgery, 75 (3); 397-405.

17. Martin SM, Cooper TY, Sterling J. Guide to extravasation management in adult patients. Hospital Pharmacy. January 2006.

18. Brown, K.A., etal (2001). Chemotherapy and biotherapy: Guidelines and recommendations for practice. Pittsburgh, PA: Oncology Nursing Society.

19. Ener, etal. Extravasation of systemic hemato-oncological therapies. Annals of Oncology 2004, 15: 858-862

APPROVALS

System Alameda AHS/Highland/John George/San Leandro Department Date: N/A 05/2020 05/2020 Pharmacy and Date: 05/2020 N/A N/A Therapeutics (P&T) Clinical Practice Date: 06/2020 N/A N/A Council (CPC) Medical Executive Date: N/A 07/2020 07/2020 Committee Board of Trustees Date: N/A N/A

Revised 5/19

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BORROWING AND LOANING MEDICATIONS BETWEEN AHS INPATIENT PHARMACIES

Department Pharmacy Effective Date 07/2020 Campus AHS System Date Revised 07/2020 Category Pharmacy Next Scheduled 09/2023 Review Document Owner System Director, Executive Chief Administrative Pharmacy Responsible Officer/Chief Nurse Executive Printed copies are for reference only. Please refer to electronic copy for the latest version.

PURPOSE To describe procedures for medication borrowing and loaning between the following AHS Inpatient Hospital Pharmacies:

340B Covered Entities • Highland Hospital Inpatient Pharmacy • Alameda Hospital Pharmacy • John George Pharmacy

Non-340B Entities:  San Leandro Hospital Pharmacy  Fairmont Pharmacy

*no medication can ever be borrowed or loaned from the Highland Hospital Outpatient Pharmacy

POLICY To ensure all medications purchased under 340B program are used on eligible patients, loaning and borrowing of medication are not allowed between a 340B covered entity and a non-340B covered entity.

For borrowing and loaning medications between non 340B entities, and 340B covered entities follow procedures below.

PROCEDURE I: 340B covered entities: For AHS inpatient hospital pharmacies that participate in the 340B program. the covered entity must be aware of all departments that receive medication and understand the purchasing source of these drugs.

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172/288 Borrowing and Loaning can only be done under the following scenarios: 1. For GPO only inventories: Medication listed on the system wide GPO exclusion list or medication purchased from a GPO only distributor. 2. Under public health emergency, if a medication is on shortage, covered entity (CE) can borrow from another CE to maintain appropriate patient care. CE is forced to “borrow/purchase” on GPO product from another entity as the last resort when no other options are available. Refer to 340B Public Health Emergency Policy for detail.

II: Non 340B Inpatient Pharmacies: 1. Any borrowing of medication must be initiated by a pharmacist or pharmacy technician. In facilities without a pharmacist on-site when a medication is needed, the on-call pharmacist must be contacted.

2. The Borrower must obtain the exact 11-digit NDC of the needed medication from the Loaner.

3. The Borrower must then confirm with their wholesaler that they can order this same 11- digit NDC medication for shipment within the next 3 days. a. If the exact NDC is not available, then the Borrower will need to call another none 340B AHS facility, other hospital in the area, or order directly thru their wholesaler. b. If the Borrow confirms the exact NDC is available, then call the Loaner and confirm that the replacement has been ordered and will be delivered within the next 3 days. i. It is the responsibility of the Borrower to deliver the replacement stock within 3 days to the Loaning pharmacy ii. If the NDC received from the wholesaler is different than ordered: 1. It is the responsibility of the borrowing facility to contact the wholesaler and request the original NDC. 2. If the wholesaler is not able to provide the original NDC, then the borrowing facility will need to compensate the loaning facility the cost of the original NDC. The NDC returned cannot be different than the NDC borrowed.

4. The Loaner will log record the transaction on a borrow/loan transaction log (Attachment #1) which includes: a. the date b. facility c. medication d. NDC and e. name of the staff requesting the medication

5. The Loaner will be responsible for confirming that the borrow/loan transaction log has no outstanding entries > 3 days.

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173/288 APPROVALS

System Alameda AHS/Highland/John George/San Leandro Department Date: N/A 07/2020 07/2020 Pharmacy and Date: 08/2020 N/A N/A Therapeutics (P&T) Clinical Practice Date: 08/2020 N/A N/A Council (CPC) Medical Executive Date: N/A 08/2020 08/2020 Committee Board of Trustees Date: N/A N/A

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MEDICATIONS: STORAGE

Department AHS COO Effective Date 03/2018 Administration Campus AHS System Date Revised 08/2017, 08/2020 Category Pharmacy Next Scheduled 09/2023 Review Document Owner Director of Pharmacy; Executive Chief Administrative Manager, Medication Responsible Officer/Chief Nurse Executive Safety Printed copies are for reference only. Please refer to electronic copy for the latest version.

POLICY All AHS pharmacies and medication rooms will maintain proper storage requirements of pharmaceuticals, biologics and chemicals.

PROCEDURE General: 1. Medications for internal use in liquid, tablet, capsule or powder form shall be stored separately from drugs for external use.

2. Test agents, germicides, disinfectants and other household substances will be stored separately from drugs.

3. Medications shall be stored and monitored at appropriate temperatures. a. Room temperature is between 20 oC (68 oF) and 25 oC (77 oF) i. Ambient Room temperature monitoring using ‘min/max’ thermometers by staff in the unit shall be documented daily during business hours ii. Action shall be taken for out of range temperatures (Table 1B) b. Refrigerated temperature is between 2.2 oC (36 oF ) to 7.7 oC (46 oF) i. Refrigerated temperature monitoring is either done by Pharmacy if the refrigerator is linked to a Pyxis Smart Remote or by the unit staff twice daily for those non-Pyxis linked refrigerators ii. For non 24/7 operating Pharmacies, nursing staff on the unit are responsible to follow “NURSING UNIT OUT OF RANGE REFRIGERATOR TEMPERATURE FOLLOW UP” and document any action been taken during out of range refrigerator temperature on the Temperature log sheet c. The medication manufacturer recommendation for storage temperature shall be adhered to when different from above.

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175/288 Pharmacy: 1. Pharmacy medication stock is stored as follows: a. Medications are alphabetized according to generic names b. Look alike/sound alike stored separately from each other c. Oral and parenteral are stored separately d. Control substances are securely stored either in an automatic dispensing machine or in a locked room to prevent diversion and according to all state and federal laws and regulations. e. All expired medications are segregated and removed from the facility by a licensed vendor. Any damaged, contaminated or partially used medications are segregated in the pharmaceutical waste bins for proper pick up and disposal. f. Medications are labeled and stored safely and securely under the proper and necessary conditions according to manufacturer’s recommendations. g. Hazardous parenteral medications will be stored separately t from non-hazardous.

2. Medications, supplies and equipment are stored separately

Nursing Units: 1. Medication rooms will be locked and secure to only authorized staff members.

2. Emergency medications that must be in public areas such as crash carts will be secured in such a way that is obvious if they have been tampered with. In addition, emergency medications will only be stored in areas where they are under continuous observation by hospital staff.

Refrigerator and Freezers 1. This excludes those refrigerators and freezers that store Vaccines for Children Program. Please refer to the Vaccines for Children Program policy for maintaining appropriate temperature monitoring for these refrigerators.

2. Refrigerators are used to maintain potency and efficacy of biologicals and heat labile substances, where refrigeration is required.

3. Stock in the refrigerators is arranged in alphabetical order in subgroups whenever possible (e.g. oral, rectal, parenteral, external, etc.).

4. Medications that must be kept frozen are placed in the freezer upon receipt.

5. All refrigerators and freezers use for medication storage shall have twice daily logs of temperature readings to ensure compliance with drug storage standards. Readings shall be available electronically through an electronic monitoring system or through manual reading documentation.

6. Nursing to follow TABLE 1A and 2A for any out of range temperatures and pharmacy to follow Table 1B, 2B, 3B for any out of range temperatures.

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176/288 7. All temperature logs will be reviewed during the medication area inspection.

REFERENCES 1. Title 22, Division 5, Chapter 1, Article 3, Section 70263. Pharmaceutical Service General Requirements

2. TJC Medication Management Standards

3. California Business and Professions Code, Division 2, Chapter 9, Article 4, Section 4076.5

APPROVALS

System Alameda AHS/Highland/John George/San Leandro Department Date: N/A 07/2020 07/2020 Pharmacy and Date: 07/2020 N/A N/A Therapeutics (P&T) Clinical Practice Date: 08/2020 N/A N/A Council (CPC) Medical Executive Date: N/A 08/2020 08/2020 Committee Board of Trustees Date: N/A N/A

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177/288 TABLE 1A NURSING UNIT OUT OF RANGE REFRIGERATOR TEMPERATURE FOLLOW UP

TEMPERATURE TEMPERATURE ACTION (oC) (oF) <0.6 oC <33 oF Nursing Action: 1. CALL Engineering 2. CALL PHARMACY to remove and transfer medication to another refrigerator. 3. Once temperature is back in range for at least 1 hour, notify pharmacy to replace medications. Pharmacy Action: Remove ALL medications immediately and transfer to another refrigerator

** for those campuses that are not 24 hours, nurse to call on-call pharmacist ** 0.6 oC to 2.1 oC 33 oF to 35 oF Nursing Action: 1. CALL Engineering. 2. If temperature not back within range within 2 hours, CALL PHARMACY to remove and transfer medication to another refrigerator. 3. Once temperature is back in range for at least 1 hour, notify pharmacy to replace medications. Pharmacy Action: 1. Remove medications if temperature not in rormal range within 2 hours.

** for those campuses that are not 24 hours, nurse to call on-call pharmacist ** 2.2 oC to 7.7 oC 36 oF to 46 oF None: record temperature 7.8 oC to 25 oC 47 oF to 77 oF Nursing Action: 1. CALL Engineering. 2. If temperature not back within range within 2 hours, CALL PHARMACY to remove and transfer medication to another refrigerator. 3. Once temperature is back in range for at least 1 hour, notify pharmacy to replace medications. Pharmacy Action:  Remove medications if temperature not in normal range within 2 hours

** for those campuses that are not 24 hours, nurse to call on-call pharmacist ** >25 oC >77 oF Nursing Action: 1. CALL Engineering 2. CALL PHARMACY to remove and transfer medication to another refrigerator. 3. Once temperature is back in range for at least 1 hour, notify pharmacy to replace medications. Pharmacy Action: 1. Remove ALL medications immediately and transfer to another refrigerator

** for those campuses that are not 24 hours, nurse to call on-call pharmacist **

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TABLE 1B NURSING UNIT OUT OF RANGE AMBIENT ROOM TEMPERATURE FOLLOW UP

TEMPERATURE TEMPERATURE ACTION (oC) (oF) <20 oC <68 oF Nursing Action: 1. CALL Engineering 2. CALL PHARMACY to assess if medications needs to be removed

** for those campuses that are not 24 hours, nurse to call on-call pharmacist ** 20 oC to 25 oC 68 oF to 77 oF None – record temperature >25 oC >77 oF Nursing Action: 1. CALL Engineering 2. CALL PHARMACY to assess if medications needs to be removed

** for those campuses that are not 24 hours, nurse to call on-call pharmacist **

TABLE 2A PHARMACY OUT OF RANGE REFRIGERATOR TEMPERATURE FOLLOW UP

TEMPERATURE TEMPERATURE ACTION (oC) (oF) <0.5 oC <33 oF Pharmacy Action:  CALL Engineering  remove and transfer medication to another refrigerator.  Once temperature is back in range for at least 1 hour, pharmacy to transfer back to original refrigerator 0.6 oC to 1.7 oC 33 oF to 35 oF Pharmacy Action:  CALL Engineering.  If temperature not back within range within 2 hours, remove and transfer medication to another refrigerator.  Once temperature is back in range for at least 1 hour, pharmacy to transfer back to original refrigerator 2.2 oC to 7.7 oC 36 oF to 46 oF None: record temperature 8.3 oC to 25 oC 47 oF to 77 oF Pharmacy Action:  CALL Engineering.  If temperature not back within range within 2 hours, remove and transfer medication to another refrigerator.  Once temperature is back in range for at least 1 hour, pharmacy to transfer back to original refrigerator >25 oC >77 oF Pharmacy Action:  CALL Engineering  remove and transfer medication to another refrigerator.  Once temperature is back in range for at least 1 hour, pharmacy to transfer back to original refrigerator

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179/288 TABLE 2B PHARMACY UNIT OUT OF RANGE AMBIENT ROOM TEMPERATURE FOLLOW UP

TEMPERATURE TEMPERATURE ACTION (oC) (oF) <19 oC <67 oF Pharmacy Action: 1. CALL Engineering 2. Assess if meds need to be relocated to another area 20 oC to 25 oC 68 oF to 77 oF None – record temperature >25 oC >78 oF Nursing Action: Pharmacy Action: 1. CALL Engineering 2. Assess if meds need to be relocated to another area

TABLE 2C PHARMACY UNIT OUT OF RANGE FREEZER TEMPERATURE FOLLOW UP

TEMPERATURE TEMPERATURE ACTION (oC) (oF) < -50 oC <-58 oF Pharmacy Action: 3. CALL Engineering 4. Assess if meds need to be relocated to another area -50 oC to -20 oC -58 oF to -4 oF None – record temperature > -20 oC > -4 oF Pharmacy Action: 3. CALL Engineering 4. Assess if meds need to be relocated to another area

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NURSE TELEPHONE ADVICE/TRIAGE

Department Ambulatory Health Care Effective Date 10/2001 Services Campus AHS System Date Revised 04/2020 Category Clinical Next Scheduled 08/2023 Review Document Director of Nursing, Executive Responsible Chief Administrative Owner Ambulatory Care Officer, Ambulatory Printed copies are for reference only. Please refer to electronic copy for the latest version.

PURPOSE To provide patient’s with evidence-based, safe instruction regarding appropriate level of care and health care advice.

POLICY Telephone call requests from patients seeking medical advice through the Ambulatory Care Department will be evaluated by a Registered Nurse (triage nurse) or a licensed independent practitioner (Physician, Physician Assistant, Certified Nurse Midwife, Nurse Practitioner).

PROCEDURE 1. The triage nurse will complete a history and focused assessment as it relates to the current complaint and document in the medical record. a recommended plan of care, the advice provided and, for non-advanced practice nurses, the protocol used.

2. Approved protocols include: a. Telephone Triage Protocols for Nurses, Julie K. Briggs b. Pediatric Telephone Protocols, Barton Schmitt c. Schmitt Thompson for Electronic Health Record integrated protocols.

3. After Hours Advice Line: Patients calling the ambulatory call center or a primary care clinic after hours seeking medical advice will be forwarded to an answering service who can connect them to an on-call physician who will provide patients with assessment and advice for their healthcare needs.

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181/288 APPROVALS

System Alameda AHS/Highland/John George/San Leandro Department Date: N/A 05/2020 05/2020 Pharmacy and Date: N/A N/A N/A Therapeutics (P&T) Clinical Practice Date: 05/2020 N/A N/A Council (CPC) Medical Executive Date: N/A 05/2020 05/2020 Committee (MEC) Board of Trustees Date: N/A N/A

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PHARMACY DISASTER PLANNING POLICY AND PROCEDURES

Department Effective Date 11/2019 Campus AHS System Date Revised 11/2019, 04/2020 Category Clinical Next Scheduled 08/2023 Review Document Pharmacy Director Executive Chief Administrative Owner Responsible Officer/ Chief Nurse Executive Printed copies are for reference only. Please refer to electronic copy for the latest version.

POLICY The Pharmacy Department will have in place an emergency management plan that will describe how to maintain and ensure effective response to disaster and emergency care.

GENERAL PROCEDURE 1. Activation and Notification  See pharmacy department phone tree

2. Emergency Codes  See AHS Emergency code card Code Description Red Fire Blue Medical emergency adult White Medical emergency pediatric Pink Infant abduction Purple Child abduction Yellow Bomb threat Gray Combative person Orange Hazardous material spill/release Silver Person with weapon/hostage Triage internal Internal disaster Triage external External disaster Stork Birth occurring outside of L&D C C-section Tan Scene safety initiated- unsafe situation involving persons with penetrating wounds Heart alert Patients presenting with STEMI Airway assist Airway assistance in interventional services suite during internal code blue Stroke Acute stroke

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3. Location of Hospital Command Center:  Located on K6, back of women’s services and across from the pediatrics clinic

Hospital Incident Command System Incident Command/Management (HICS) - Management of overall emergency coordination and policy: command, Command Center Numbers: control and communicate . Highland 510-437-4321 Operational Chief . Fairmont 510-895-4550 - Coordinates all operations in support . JGPP 510-346-1340 of the response to the emergency . Alameda 510-814-4646 Planning Chief . San Leandro 510-667-4580 - Situation analysis, collects, evaluates, documents and assess information related to the incident Logistics Chief - Proves facilities, services, personnel, equipment and materials in support of the incident Finance Chief - Provides financial and cost analysis and administrative aspects

4. Communications a) Codes: see AHS code card above b) Call Back Process: see pharmacy phone tree (Pharmacy share Bioterrorism (disaster planning) folder  phone tree folder) c) Staff Responsibilities/Expectations during an emergency: see below detailed pharmacy policies

5. Equipment: see below detailed pharmacy policies

7. Process for Staff count:  Pharmacy Director or designee to designate person to do head count  Check daily schedule and report total people present/absent

8. Shelter-In-Place Instructions: per hospital policy

9. Lockdown Instructions: pharmacy already has secure access to enter (key pad)

10. Process for Patient Discharge: see MCI procedures for detail

11. Evacuation Procedures:  Will follow hospital map for evacuation and also see Pharmacy Fire Procedures (Pharmacy share Bioterrorism (disaster planning)  Fire safety and evacuation folder)

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184/288  Closest stairwell available for everyone to use: K building by K-building elevators  Alternate stairwell if K building stairwell unavailable: K building by the back of old cath lab  No use of elevators in cases of fire emergency

12. Identification of Emergency Equipment  Fire extinguishers: o By break room door o By outpatient pharmacy Scriptpro machine  Fire alarm o By lab check-in wall

13. Downtime Procedures: see details below

14. Location of Staff Contact List (emergency call back/contact numbers): Pharmacy share Bioterrorism (disaster planning) folder  phone tree folder

Pharmacy Disaster Planning Procedures: this policy and procedures is located in Pharmacy Shares  Disaster planning folder  Pharmacy disaster planning procedure folder

General responsibilities:  Maintain your own safety  Earthquake: o Drop, cover and hold o If there is no table to hide underneath, can either drop against an internal wall and cover your head OR get to an open space and drop and cover  Once safe, resume your usual responsibilities unless you are sent to the staff pool to help outside of the pharmacy department  Phone pharmacy staff to enlist extra help if needed: location of staff contact list: Pharmacy share Bioterrorism (disaster planning)  phone tree folder  For disaster that occur at specific campuses (HGH, JGP or Fairmont), please follow the instructions from the respective command centers. For disasters that occur on a large scale, different campuses may need cooperation with each other and can communicate via the phone triage tree

PHARMACEUTICAL SUPPLY FOR EMERGENCIES 1. Pharmacy will keep the regular stock of meds on the shelf and in Pyxis machines at a minimum PAR level of 96 hour supply

2. Pharmacy has established a process with the current wholesaler for a list of emergency medications (including controlled medications) that will be automatically sent by the current wholesaler in the event of a disaster AND we lose communication abilities with the current wholesaler for ordering meds. This list contains mostly medications that are more acutely needed to match disasters or MCI event (pain, antibiotics, intubation, sedation meds, etc). See attachment 2.

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3. In the event of bioterrorism, the chempak supply is kept in enough quantities currently as established by the Environmental Health and Safety (EH&S) Manager. See Pharmacy share Bioterrorism (disaster planning) bioterrorism policy and labels folder

SPECIFIC DISASTER TYPE: Water disruption  Should receive outside water source within 12 hours  Pharmacy will keep our own backup supply of water for hand washing (6 gallons) and compounding oral medications. Located on top shelf of rack behind Buyer’s area  IF water resource is running low: minimize IV use o IF an emergent/urgent IV is required, mix in IV room or o Extra hand supplies can be ordered from central supply/EVS (see below) o Instruct nurses to clean hands thoroughly with sanitizer towels and alcohol sanitizers before compounding the IVs  Hand cleaning for toilets/commodes and hand hygiene when compounding, use stocked alcohol hand sanitizers and alcohol pads in the pharmacy  Call the following to retrieve extra supplies during a disaster o Central Supply has the following (x44241) . Alcohol pads (5 boxes requested to be available) . Bottled sterile water for irrigation (5 one liter bottles requested to be available) . Syringes (2 boxes of each size: 1mL, 3mL, 5mL, 10mL, 20mL, 50mL requested to be available) . Needles (18 gauge- 5 boxes requested to be available) o EVS (x44626) . Alcohol foams (request amount needed at the time) . Alcohol gels (request amount needed at the time) . Paper towels

Earthquake  If hospital evacuation is required o Follow hospital evacuation procedures o Last person out of the pharmacy need to ensure the doors are locked so the medications are secured inside pharmacy  If influx of patients to be seen at HGH o Notification and alert: call necessary pharmacy staff to meet needs of the disaster, see list of pharmacy staff phone numbers in Pharmacy share Bioterrorism (disaster planning)  phone tree folder o See MCI plans below  Power outage o Loss of communication with the current wholesaler: pre-arranged medication delivery from Cardinal will be activated so that emergency supply of medications will be sent to HGH . Medication list- see attachment 2

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186/288 o Utilize back-up power . Back-up power source can be accessed by using the RED power outlets located in the pharmacy . The inpatient refrigerators the CII safe and the outpatient pharmacist check stations across from the filling station are already plugged into the back-up power outlets . Move electrical machines such as the copier and computer to access these outlets for use . Unused back-up power outlets in the pharmacy Location Number of outlets available Behind Thermo Scientific Freezer 2 Behind storage for oxytocin bags 2 Behind CII safe 4 By outpatient cashier machine and 1 behind confidential trash By outpatient window #1 2 By outpatient window #3 2 Outpatient pharmacist check station 1 closest to ScriptPro Area next to Beverely’s desk 1 o If Epic/ScriptPro/WAMB is down . Manual labels-inpatient  See attached samples in binder  To access electronically, go to: o IV labels: Pharmacy share Disaster planning folder  pharmacy disaster planning folder pharmacy disaster planning- inpatient IV labels . Print on normal paper then cut and tape on IV bags OR use blank IV labels from printer to write on OR print with Avery #5164 labels if available o Unit dose labels: Pharmacy share Disaster planning folder  pharmacy disaster planning folder pharmacy disaster planning- outpatient labels . Print on normal paper then cut and tape on IV bags OR use blank IV labels from printer to write on OR print with Avery #5263 labels if available o Patient medication profile tracking . Use the blank MAR forms to keep track of patient medication profiles . See blank copies in binder also  Drug references-Drug Information Handbooks are available on pharmacy shelf . Manual labels-outpatient  See attached samples in binder

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187/288  To access electronically, go to: Pharmacy share Bioterrorism (disaster planning)  pharmacy disaster planning- outpatient labels o Use Avery #5263 size labels to print OR use blank labels to write on o Patient medication profile tracking . Use the blank MAR forms (attachment 5) to keep track of patient medication profiles . See blank copies in binder also  Drug references-Drug Information Handbooks are available on pharmacy shelf o If all power is out . Hand write labels on the unit dose and IV blank labels  Location of labels: in pharmacy storage room by Buyer’s area . Use back-up flash light to operate within the pharmacy and for medication deliveries  Location of flash lights: in bin under the prepack machine, in bin by the crash cart meds and in HCP IV room

. Patient medication profile tracking  Use the blank MAR forms (attachment 5) to keep track of patient medication profiles  See blank copies in binder also o Drug references-Drug Information Handbooks located throughout pharmacy o If IV room not functioning during power outage, can compound emergent IVs without IV hood with BUD of 1 hour after mixing

Fire: see Pharmacy share Bioterrorism (disaster planning)  Fire safety and evacuation folder for details

R.A.C.E R= Rescue those in immediate danger A= Alert by activating the alarm C= Confine by closing all doors E= Extinguish the fire if safe to do so; otherwise evacuate P.A.S.S P=Pull the pin A= Aim at base of fire S= Squeeze trigger S= Sweep side to side at base of fire

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188/288 EVACUATION SITE: K-Building Level 3 Elevator Lobby

Bioterrorism: see bioterrorism policy

Chemical emergency: see Chempak policy

FEMA: see FEMA policy

Mass Casualty Incident (MCI) Notification and alert: follow phone tree to all for help as needed (most updated version in Pharmacy share Bioterrorism (disaster planning)  phone tree folder). An updated phone tree can also be found in the pharmacy disaster binder

Staff responsibilities and rearrangements specifically for the MCI event:

Operations Flow during MCI event

1. Information for hospital a. For non-MCI questions call x44223 (inpatient) b. For MCI questions call x44223 (inpatient) and also ED pharmacist 510-294-8302

2. Inpatient pharmacists a. Continue to take care of admitted patients b. May have higher volume of things to check: narcotics, tetanus shots, RSI kits, crash cart trays for ED, OR, ICU, outdoor triage area

3. Inpatient technicians a. Continue to take care of admitted patients b. May have to check and refill pyxis more often, especially in critical areas (ED, ICU) c. Run reports for ER, OR, ICU to ensure narcotics, RSI kits and crash cart trays are adequately stocked d. Some technicians may be assigned to deliver meds to MCI patients in the ED or the triage tent outside i. May have to pull additional SAN staff or outpatient staff for help

4. Outpatient pharmacists a. Some assigned to handle discharge patients as usual b. Some assigned to handle outpatient prescriptions as usual c. Some may be pulled to help inpatient

5. Outpatient technicians a. Some assigned to handle discharge prescriptions as usual b. Some assigned to handle outpatient prescriptions as usual c. Some technicians may be assigned to deliver meds to MCI patients in the ED or the triage tent outside

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189/288 6. SAN pharmacists- to be assigned to areas of need

7. SAN technicians- to be assigned to areas of need

8. Clinical pharmacists – wherever you go, ID yourself as the pharmacist a. ED i. Deliver meds ii. Write prescriptions/enter orders as needed iii. Attend codes iv. Triage problems v. Answer drug information questions vi. Triage problems for non-MCI patients b. Other units i. Triage problems for MCI patients ii. Triage problems for non-MCI patients

9. Delivery medications to outdoor triage area (MCI area) a. Emergency response (within first 30min of event) MCI kit i. Pharmacy will keep a list of medications for the emergency MCI kit (from the Emergency Preparedness Committee) 1. IV acetaminophen 1000mg/100mL premixed bottles #10 2. IV ketoralac 30mg vials #25 (1 box) 3. IV fentanyl 50mcg/mL (2mL) vials #50 (2 boxes) ii. When the MCI is activated by the command center, pharmacy will be notified and pharmacy will sign out the required medications on the list above to bring to the surge tent area iii. Pharmacy will give priority to fill this list of medications upon MCI activation and notification from the emergency response team 1. The MCI kit meds will be signed out from the pharmacy as per below: a. For the fentanyl, sign this out from the CII safe to location “MCI kit” b. When the CII receipt prints out for the fentanyl, put the non- narcotic medications and quantities on this form as well c. Bring the CII receipt to the surge tent area and once the medications are given to the receiver at the tent, the person receiving these medication will sign the narcotic form for the fentanyl printed from the CII safe and pharmacy will keep this in the pharmacy disaster binder for record-keeping d. Bring10 copies of attachment 3, 4 and 5 with the medications to the surge tent to give to the surge tent person receiving the medications to keep dispensing record iv. Any unused medication(s) from the MCI kit after the event will be returned to the pharmacy by a member of the emergency response team to be accounted for and restocked by the pharmacy b. Medications not on the MCI kit list provided by the Emergency Preparedness Committee will be requested using the drug requisition form

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190/288 c. Drug requisition form (attachment 3), the form will contain: i. Date ii. Name of drug iii. Dose iv. Quantity d. Medications dispensed must be documented on a medication dispensing log (attachment 4- separate sheets for non-narcotics and narcotics), the form will contain: i. Date ii. Patient name iii. Drug name iv. Drug strength v. Quantity e. Medication administration for patients will be documented on the paper MAR (Attachment 5) f. The drug requisition form, medication dispensing log and paper MAR will be supplied by the pharmacy upon request g. All the medication dispensing logs should be returned to the pharmacy to keep on file in the pharmacy disaster binder for record and to be able to reconcile medications dispensed after the MCI event h. Delivery of narcotics not already part of the MCI kit in the surge tent or non-pyxis areas: i. Pharmacy will sign these out from CII safe pyxis ii. These narcotics will be sent from the CII safe pyxis to “MCI triage area” iii. The nurse requesting/picking up the narcotics must sign on “pyxis delivery receipt” that prints out from the pyxis 1. Pharmacy will keep the pyxis delivery receipt in the Pharmacy Disaster planning Binder iv. Once the narcotics arrives in the MCI area, it will be dispensed and tracked with the medication dispensing log v. Print copies of attachment 3, 4 and 5 for the person picking up the medication to keep track of dispensing and administration of meds

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APPROVALS

System Alameda AHS/Highland/John George/San Leandro Department Date: N/A 04/2020 04/2020 Pharmacy and Date: 4/2020 N/A N/A Therapeutics (P&T) Clinical Practice Date: 05/2020 N/A N/A Council (CPC) Medical Executive Date: N/A 07/2020 07/2020 Committee Board of Trustees Date: N/A N/A

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Attachment 1- see phone tree folder in the pharmacy disaster folder for the most updated version and for the actual phone tree

HIGHLAND PHARMACY DEPARTMENT’S EMERGENCY PHONE TREE

When Calling:  The person at the top will start the tree and it may be helpful to have a brief script complete with the specific action.  Ask the person to get paper and pencil to write specifics  Give facts about the event  If nobody is answering, leave a message and call the next person. The caller should continue down the phone tree until a person answers. Continue attempting contact with unavailable persons. This should ensure that everyone gets the information in a timely fashion.  Confirm they will be making the next call on the list.  Prearrange with staff at the end of the list to contact the person at the top once they receive the message. The LAST person on the phone tree should CALL THE FIRST person to ensure that the tree is completed and that the message was accurate.

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193/288 Attachment 2 Emergency medication list to be delivered automatically by the current wholesaler – Adult inpatient Drug Form Amount for AHS (amount is variable) Analgesic Acetaminophen Inj: 1g/100mL 2boxes PO: 325mg tabs 10 boxes Fentanyl IV: 50mcg/mL 200 vials

Hydorcodone/APAP PO: 5/325mg tab 10 boxes Hydromorphone PO: 4mg 3 boxes IV: 1mg/mL syr 35 boxes 2mg/mL syr 15 boxes Ibuprofen Tab: 400mg 10 boxes Ketorolac Inj: 30mg/mL 2 boxes 15mg/mL 2 boxes Morphine PO: 15mg IR tab 5 boxes 30mg ER tab 5 boxes IV: 4mg syr 20 boxes 2mg syr 25 boxes Antibiotics Acyclovir Inj: 50mg/mL 3 boxes Amikacin Inj: 250mg/mL 3 boxes Ampicillin IV: 2 g 3 boxes Azithromycin PO: 500mg tab 4 boxes Aztreonam IV 1 g vial 5 boxes IV: 2 g vial 5 boxes Cefazolin IV: 1g/50mL ISO premixed 4 boxes bag 4 boxes IV: 2g/100mL ISO premixed 4 boxes each bag IV: 1g and 0.5g vials Cefepime IV: 1g vial 4 boxes IV: 2g vial 4 boxes cefoxitin IV: 1g in 50mL D5W 5 boxes IV: 2g in 100mL D5W 5 boxes IV: 1g and 2g vials 5 boxes each ceftazidime IV: 1g in 50mL D5W 5 boxes IV: 1g vial 5 boxes IV: 2g vial 5 boxes ceftriaxone IV: 1g in 50mL ISO premixed 5 boxes bag 5 boxes IV: 2g in 50mL ISO premixed 5 boxes each bag IV: 1g and 2g vials

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194/288 Antibiotics Cephalexin PO: 500mg tab 4 boxes Clindamycin IV: 900mg vials 4 boxes Doxycycline IV 100mg vial 3 boxes PO 100mg 5 boxes Fluconazole IV: 200mg/100mL premixed 3 boxes 400mg/200mL premixed 3 boxes PO: 200mg tab 5 boxes Gentamicin Inj: 80mg/100mL bag 4 boxes Levofloxacin IV: 750mg bags 3 boxes 500mg bags 3 boxes PO: 750mg tab 2 boxes 500mg tab 2 boxes Meropenem IV: 1g vials 4 boxes Metronidazole Inj: 500mg/100mL bag 2 boxes PO: 500mg tab 4 boxes Micafungin Inj: 100mg/vial 5 vials Pen G benzathine IM: 24 million unit 2 boxes Penicilline G potassium IV: 5 million unit vials 3 boxes IV: 3 million unit/50mL bags 3 boxes Pipercillin/tazobactam IV: 2.25g/50mL ISO premixed 5 boxes bag 5 boxes 3.375g/50mL ISO 5 boxes premixed bag 10 boxes each 4.5g/100mL ISO premixed bag IV: 2.25g, 3.375g, 4.5g vials SMX/TMP PO: 800/160mg tab 4 boxes Vancomycin IV: 10 gram vials 15 vials 1000mg/200mL ISO 5 boxes premixed bag 5 boxes 500mg/100mL ISO 5 boxes premixed bag 750mg/150mL ISO premixed bag Voriconazole Inj: 200mg/vial 10 vials Anticoagulants Enoxaparin SQ: 30mg inj syr 20 boxes 40mg inj syr 205 boxes 60mg inj syr 10 boxes Heparin SQ: 5000 units/mL 12 boxes IV: 1000 unit/mL (10mL) 4 boxes 2 units /mL (500ml) 4 boxes

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Antiemetic Metoclopramide IV: 5mg/mL vials 2 boxes Ondansetron PO: 4mg tab 5 boxes PO: 4mg ODT tab 10 boxes IV: 4mg/mL 12 boxes Anxiolytic Lorazepam IV: 2mg/mL 8 boxes PO: 1mg 10 boxes 2mg 4 boxes Midazolam IV: 1mg/mL 8 boxes Crash Cart/CODE meds Adenosine PED/Adult: 6mg/2mL vials 3 boxes Alteplase Inj: 100mg vials 4 vials Amiodarone IV: 150mg/3mL amp 5 boxes 50mg/mL (18mL) 4 vials 150mg/100mL ISO 1 box premixed bag 1 box 360mg/200mL ISO 1 box premixed bag PO: 200mg tab Amlodipine PO: 5mg tab 5 boxes Atropine Neonate/PED: 0.25mg/5mL 5 packets of 10 syr 5 packets of 10 Adult: 1mg/10mL syr Dextrose INJ: 50% (25g/50mL) syr 5 packets of 10 Cisatracurium Inj: 10mg/mL (20ml) 20 vials Dobutamine IV: 1000mg/250mL premixed 6 boxes bag Dopamine Adult: 400mg/250mL bag 4 boxes Esmolol IV: 2000mg/100mL premixed 2 boxes bag Etomidate IV: 2mg/mL 10mL vial 4 boxes Epinephrine Neonate/PED: 1mg/10mL syr 5 packets of 10 1:10000 5 packets of 10 Adult: 1mg/10ml syr 1:10000 1 box 1mg/mL vial (1mL) 1 box 1mg/mL vial (30mL) Glucagon Inj: 1mg vial 1 box Hemabate Inj: 250mg ampoules 1 box Ketamine Inj: 100mg/mL (5mL) 5 boxes Lidocaine 2% IV: 100mg/5mL syr 5 packets of 10 Mannitol IV: 20% of 250mL 1 box Methergine Inj: 0.2mg/mL ampoules 1 box

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196/288 Crash Cart/CODE meds Misoprosstol PO: 100mg tab 1 box Naloxone Inj: 0.4mg/mL 4 boxes Nifedipine PO: 30mg ER tab 4 boxes Norepinephrine IV: 1mg/mL (4mL) vial 160 boxes

Phenylephrine IV: 10mg/mL (10 or 25mL) 4 boxes Propofol Inj: 20mL vials 8 boxes 100mL vials 6 boxes

Rocuronium IV: 10mg/mL vial (10mL) 4 boxes Sodium bicarb Neonate/PED: 4.2% 5 packets of 10 (5meq/10mL) syr 5 packets of 10 Adult: 8.4% (50meq/50mL) syr Succinylcholine IV: 20mg/mL vial 5 boxes Vasopressin INJ: 20unit/mL vial 2 boxes Vecuronium Inj: 20mg vials 4 boxes Electrolytes Potassium phos IV: 3mmol/ml 2 boxes Tabs: 500mg 2 bottles Calcium chloride IV: 10% vials/syringes 5 packets of 10 Calcium gluconate IV: 10% vials 4 boxes Magnesium sulfate IV: 1g/mL (2mL) vials 2 boxes 1g premixed bags 2 boxes 40g/1000mL premixed 2 boxes bags Potassium chloride Inj: 2meq/mL (20mL vials) 100 10 meq /100mL premixed 4 boxes bag 1 bag 20meq/100mL premixed 8 boxes bag 4 boxes PO: 20meq tabs 40meq/30mL liq Potassium phos IV: 3mmol/ml 2 boxes Tabs: 500mg 2 bottles Sodium phosphate PO: phos-NaK packets 2 boxes

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Heart meds Aspirin PO: 81mg chew tabs 5 boxes PR: 600mg suppository 1 box Apixaban PO: 2.5mg tab 5 boxes Atorvastatin PO: 40mg tabs 5 boxes Carvedilol PO: 6.25 and 12.5mg tabs 4 boxes each Clevidipine Inj: 0.5mg/mL (100ml) 5 boxes Clopidogrel PO: 75mg tab 5 boxes Diltiazem Inj: 5mg/mL (5mL) 2 boxes Esmolol INJ: 2000mg/100mL 1 box premixed Furosemide INJ: 10mg/mL –4mL 2 boxes -- 10mL 2 boxes PO: 40mg tabs 2 boxes Hydralazine IV: 20mg/ml vials 4 boxes PO: 25mg tabs 2 boxes Labetalol IV: 5mg/mL (20mL) 50 vials Lisinopril PO: 10 and 20mg tab 4 boxes each Metoprolol IV: 1mg/mL 2 boxes PO: 50mg regular tabs 2 boxes 25mg XL tabs 2 boxes Nitroglycerine IV: 50mg/250mL premixed 3 boxes bottle 3 boxes 100mg/250mL premixed 2 boxes bottle 1 box PO: 0.4mg SL tabs Ointment: 1g/packet Propranolol Tab: 10mg 1 box Rivaroxaban Tab: 15mg tab 4 boxes 20mg tab 4 boxes Insulins Insulin lispro INJ: 100units/mL (3mL) 10 vials Insulin glargine INJ: 100units/mL pen 10 vials Insulin regular INJ: 100units/mL 10 vials

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Misc Alteplase 2mg/vial 10 vials Benztropine Inj: 1mg/mL 1 box Bisacodyl PO: 5mg tab 4 boxes PR: 10mg suppository 3 boxes Dexamethasone Inj: 4mg/mL 6 boxes 10mg/mL (1mL) 2 boxes Dexmetdetomidine Inj: 100mcg/mL 4 boxes IV: 400mcg/100mL premixed 5 boxes bottle 5 boxes 200mcg/100mL premixed bottle Diphenhydramine IV: 50mg/mL 4 boxes Caps: 25mg 2 boxes Docusate Cap: 100mg 4 boxes Liq: 100mg/10mL 4 boxes Famotidine PO: 20mg tab 10 boxes Inj: 10mg/mL (2mL) vials 10 boxes Fosphenytoin Inj: 100mg/2mL (20mL) vials 2 boxes Glycopyrrolate Inj: 0.2mg/mL (5mL) 4 boxes Haloperidol Inj: 5mg/mL 4 boxes Hydrocortisone IV: 100mg vials 5 boxes Lactulose PO: 20g/30mL 6 boxes Levetiracetam Inj: 500mg/5mL vial 5 boxes 500mg/100mL premixed 5 boxes bag 5 boxes 1000mg/100mL premixed 4 boxes bag 4 boxes PO liq: 500mg/5mL PO tab: 500mg tab Levothyroxine Inj: 100mcg/vial 2 vials Tab: 50mcg tab 4 bottles Lidocaine 2% jelly Packet 2 box Methylprednisolone Inj: 125mg vial 4 boxes Tdap vaccine Inj: 0.5mL 5 boxes Td vaccine Inj: 0.5mL 5 boxes Tetanus immune globulin Inj: 250units/mL Maalox Soln: 30mL cups 4 boxes Methylprednisolone Inj: 1g/vial 4 vials Nimodipine Gel Cap: 30mg 1 bottle NS vials 10mL vials for reconstitution 8 boxes Octreotide Inj: 500mcg/mL 2 boxes Oxytocin Inj: 10unit/mL 4 boxes

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Misc Phenylephrine 0.25% (15mL) 15mL nasal spray 10 bottles

Prednisone Tab: 10mg 4 boxes Pantoprazole Inj: 40mg/vial 8 boxes Tab: 40mg 4 boxes2 boxes Packets: 40mg Phenobarbital IV: 130mg/mL 1 box 65mg/mL 1box Phenytoin IV: 50mg/mL (2mL) 2 boxes Cap: 100mg 2 boxes Phytonadione IV: 10mg inj 2 boxes Prochlorperazine INJ: 10mg/2mL vial 2 boxes Racemic epi Vials: 2.25%/0.5mL 1 box Sterile water 10mL vials for reconstitution 8 boxes Sevelemar Tab: 400mg 1 bottle 800mg 1bottle Powder: 800mg 1 box Thiamine Inj: 100mg/mL 2 boxes Tranexamic acid Inj: 100mg/mL 10mL SDV 5 boxes Valproic acid Inj: 500mg/5mL (5mL) 2 boxes Nebs/Inhalers Acetylcysteine INH: 200mg/mL (30mL vials) 2 boxes Advair 50/500mcg 10 inhalers Albuterol Inh: 90mcg/inh 25 inhalers Neb: 2.5mg/3mL 10 boxes INH: 5mg/mL (20mL) vials 20 vials Combivent Inh: 20/100mcg inhalers 10 inhalers Ipratropium Inh: 17mcg/actuation inhalers 10 inhalers Neb: 0.5mg/2.5mL 8 boxes Spiriva 18mcg inhalers 10 inhalers OR/Anesthesia Bacitracin/polymixin oint 14.2g tube 4 boxes Bupivacaine PF Inj: 5mL/mL (10ML) 4 boxes Dantrolene Inj: 20mg/60mL bottles 10 bottles

Intralipid 20% Inj: 20% 250mL bag 1 box Lidocaine 1% PF Inj: 5mL vials 4 boxes Lidocaine 2% PF Inj: 5mL vials 4 boxes Lidocaine with epi Inj: 1% and 1:100000 (30mL) 1 box 2% and 1:100000 (30mL) 1box PF 2% and 1:200000 1 box (20mL) Mepivacaine 1.5% Inj: 1.5% (30mL) vial 4 boxes

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200/288 OR/Anesthesia Neostigmine INJ: 1mg/mL (10mL) 1 box Ropivacaine 1% Inj: 1% (20mL) vials 4 boxes Sevoflurane 250mL 10 vials Sugammadex Inj: 100mg/mL (5mL) vials 10 vials Thrombin 20MU each box 4 kits Pharmacy Supplies Pharmacy labels IV 1 box Oral dose 1box Plastic bags 4x6 1 box 5x8 1box

Additional supplies  Central Supply can supply the following (x44241) o Alcohol pads (5 boxes requested to be available) o Bottled sterile water for irrigation (5 one liter bottles requested to be available) o Syringes (2 boxes of each size: 1mL, 3mL, 5mL, 10mL, 20mL, 50mL requested to be available) o Needles (18 gauge- 5 boxes requested to be available) o Gloves (2 box each of small, medium, large gloves) o IV fluids NS and D5W all mL sizes per IV tech on need  EVS can supply the following (x44626) o Alcohol foams (request amount needed at the time) o Alcohol gels (request amount needed at the time)

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201/288 Emergency medication list to be delivered automatically by the current wholesaler - pediatric inpatient

Drug CIN Strength # units needed Acetaminophen PO: 160mg/5mL 5 bottles Alprostadil Inj: 500mg/mL 2 Ampicillin Inj: 500mg vial 4 Beractant Inj: 200mg/8mL 2 Destin ointment Onit: 40% 28g tube 10 tubes Dopamine Inj: 400mg/10mL 2 Erythromycin opth Opth oint: 1gram 3 oint Ferrous sulfate drops Drops: 15mg/mL (50ml) 5 Gelfoam small Sponge: 12-7 10 sponges Gentamicin inj Inj: 10mg/mL (2mL) 2 Glycerin infant supp Supp 2 Heparin flush Flush: 30 units/3mL 2 Hepatitis B vac Inj: 5mcg/0.5mL 5 Ibuprofen solution Oral solution: 100mg/5mL 5 bottles (118mL) Lorazepam inj Inj: 2mg/mL 2 Morphine inj Inj: 2mg/mL 2 Morphine solution Syr: 0.4mg/mL syringe 5 Morphine liquid Solution: 10mg/5mL liquid 3 MVI drops Drops: 50ml bottle 5 bottles Naloxone inj Inj: 0.4mg/mL 2 Naloxone inj Syr: 2mg/mL 2 Nystatin susp Susp: 100KU/mL 5 Phenobarbital inj Inj: 130mg/mL 3 Phytonadione Inj: 1mg/0.5ml 3 Sodium bicarbonate Syr: 5meq/10mL 2 inj Sodium chloride inj Inj: 23.4% 5

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202/288 Attachment 3: Drug requisition form

Date Drug Name Drug Strength QTY

Requested By:______Filled by:______Checked by:______

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203/288 Attachment 4

EMERGENCY MEDICATION DISPENSING LOG

Drug/Str Date Patient Name Dispensed QTY Initial

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204/288 Attachment 4 cont

EMERGENCY NARCOTIC DISPENSING LOG

Drug/Str Date Patient Name Dispensed QTY Initial

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205/288 Attachment 5

PATIENT MEDICATION ADMINISTRATION RECORD

MEDICATION Date TIME Patient Name GIVEN Initial

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PROBATE CONSERVATORSHIP POLICY

Department Care Management Effective Date 07/2020 Campus AHS System Date Revised 08/2020 Category Clinical Next Scheduled 08/2023 Review Document Manager, Care Management Executive Vice President, Care Owner Responsible Management Printed copies are for reference only. Please refer to electronic copy for the latest version.

PURPOSE The purpose of this policy is to outline the steps necessary in the process of seeking to obtain probate conservatorship on behalf of an AHS patient for has been admitted to the hospital for medical care but the capacity of the patient is in question. Care Management staff are at times faced with balancing the eligible adult’s right to self-determination and the responsibility to protect the adult who may not have the capacity to meet his/her basic needs. In some cases when all other options have been exhausted, it may be necessary to involve the court system when the adult lacks capacity to act in his/her own self-interest. Depending on the eligible adult’s circumstances, petitioning for guardianship and/or conservatorship may be the only option. The purpose of this policy is to provide guidance to Care management staff in initiating the probate conservatorship process.

POLICY The Probate Conservatorship policy outlines the process of assessing patients who may need protection due to their inability to provide for their own needs. The goals of this policy are to ensure the patients proper care and treatment. The goal of Care Management staff is to ensure that patients who are unable to provide for their basic needs of physical health, food, clothing and shelter and who are unable to manage their own financial affair and are vulnerable to financial mismanagement have access to a representative that can advocate and protect their well-being.

PROCEDURES A. Care Management staff should first conduct, complete and document a thorough due diligence process as outline in the Incapacitated and unrepresented patient policy. This process should be initiated within the first week of the patient’s admission. (See Attachment) B. Staff shall clearly and concisely document all contacts and information collected to with a complete and accurate depiction of the eligible adult’s circumstances. C. Alternatives for maintaining or providing care shall be explored and documented by staff with the patient (if the patient is able to participate) before considering legal intervention. These alternatives, when appropriate, may include but are not limited to supported decision

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making, arranging for a caregiver, delivery of meals, someone to check on the individual daily, appointment of a power of attorney (POA), durable power of attorney (DPOA), payee,. D. If there is no family member or friend has been identified who could represent the patient and the patient has income, the probate conservatorship packet should be completed. This should be initiated by the patient’s second week of admission. E. The hard copies of the packet are sent to the conservator’s office via mail. F. Once the Alameda County conservator receives the packet, a conservator is assigned the case and the application for conservatorship is sent to County Counsel and reviewed. A court date is set. Alameda County’s Conservator’s office will provide the final determination. G. Once the court has appointed a conservator, this person must be consulted and made aware of any and all potential medical procedures, transfers to another facility or any other medical determination necessary to be made for the patient.

T. TEMPORARY CONSERVATORSHIPS (1) Petition for Appointment The petition for appointment of a temporary conservator may be filed only with or after the filing of a petition for appointment of a general conservator. The petition must state facts establishing the urgency requiring the appointment of a temporary conservator. A situation requiring immediate action to protect the health, welfare, or the estate of the proposed conservatee will be sufficient. Ordinarily, a situation requiring immediate action constitutes good cause.

REFERENCE https://www.scscourt.org/court_divisions/probate/probate_rules/probate_rule11.shtml#T

APPROVALS

System Alameda AHS/Highland/John George/San Leandro Department Date: N/A 07/2020 07/2020 Pharmacy and Date: N/A N/A N/A Therapeutics (P&T) Clinical Practice Date: 08/2020 N/A N/A Council (CPC) Medical Executive Date: N/A 08/2020 08/2020 Committee Board of Trustees Date: N/A N/A

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ATTACHMENT I Procedure for Conducting Due Diligent Search as part of AHS Health Decisions for Incapacitated Unrepresented Patients Policy

These cases are often complex and challenging. The ethics committee is always available to offer assistance, guidance, and advice.

The purpose of the due diligent search is to:  Search for surrogate decision maker or members of patient’s support network  Gather evidence of patient’s values, beliefs, preferences, and any other relevant data

Procedure for social workers conducting the due diligent search: 1. The social worker will conduct a chart review to look for: a. any prior statements of wishes or documentation of treatment preferences b. any prior decisions made, c. any prior surrogate decision makers d. any prior advance directives. e. any record of the patient’s PCP and other involved care providers f. any record of agencies the patient may have once been a client of, skilled nursing facility in which they lived, homeless shelter or other provider of services they may have frequented. g. In all instances the due diligent search seeks to identify potential surrogate decision makers and/or information about the patient’s values, beliefs, preferences. To that end, when talking to potential surrogate decision makers or prior providers of care it is important to seek any information that might shed light on the patient’s values, goals, beliefs, preferences, priorities, and world view that could inform our care.

2. In an effort to identify appropriate surrogate decision makers the social worker will also: a. With the assistance of a witness (document who this is) search throughout the patient’s personal effects for any identifying information. b. Review phone numbers in the patient’s cell phone and make contact c. Review the reports by Ambulance EMT, and other emergency personnel. d. Search address on the internet to locate any phone numbers connected with address of ambulance pick up location e. Post a message on the wall of the patient’s room asking visitors to talk to the social work or nursing staff

3. If still unable to identify appropriate surrogate decision maker the social workers will. a. Seek assistance from local police to place a notice at the patient’s last known residence or to visit the location where the patient was found or most recently lived b. Search internet for phone numbers connected to the patient’s name c. Contact AHS Homeless teams, Urgent Care and K6 staff d. Contact the AHS’s Private Investigator e. Contact the California Advance Health Care Directive Registry by faxing a letter of inquiry to 916-651-9805

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4. If his or her identity is established but no advance directives or evidence of treatment preferences have been identified: a. Search the current and historical electronic health record for information regarding medical preferences b. Contact PCP and/or community providers if none found within AHS.

5. Once potential decision makers are identified consider using the following script to explain why you are speaking to them and how they can help a person in need. Ask for contact information for anyone they think may know the patient. Be sure to ask them what they know about the patient- anything from which we can glean information regarding the patient’s values and beliefs can be helpful:

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RESIDENT TRUST FUND ACCOUNTS POLICY AND PROCEDURES

Department Accounting Services Effective Date 07/2020 Department Campus AHS System Date Revised 06/2020 Category Finance Next Scheduled 08/2023 Review Document Owner Director, Accounting Executive Chief Financial Officer Services Responsible Printed copies are for reference only. Please refer to electronic copy for the latest version.

PURPOSE The purpose of this policy is to document the guidelines and procedures to administer the patient (resident) trust fund accounts in the Alameda Health System (AHS) facility locations.

POLICY It is the policy of AHS to ensure there are adequate internal controls and segregation of duties to safeguard, account for and administer the resident trust fund account in each facility location.

BACKGROUND A resident trust fund is money held by a nursing facility for residents of the facility. It is financial account set up with residents’ funds to use for their personal needs and cannot be used for any other purposes. All participating residents’ funds are combined in a single bank account. However, each resident’s transactions are accounted for and individually documented. Expenditures from the patient fund account may not exceed the drawing right that the patient has in the account. Expenditures from the patient fund account shall only be for the immediate benefit of that particular patient.

The residents who receive Medicaid benefits must also be aware that if their funds go above the resource limitation threshold, they may lose their Medicaid coverage until the money is spent down. In addition, the facility is obligated to keep the trust account funds separate from the facility’s operating funds and they are required by law to regularly update residents on the activities and status of their accounts. Residents with money in the trust should have access to cash on an ongoing basis. An individual financial record (ledger sheet) is available through quarterly statements and upon request of the resident/legal representative. Proper bookkeeping (accounting principles) are used in the maintenance of the written or computerized individual ledger accounts.

FACILITY LOCATIONS The two AHS facility locations with resident trust fund accounts (as of the date of this policy)

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211/288 are as follows: Fairmont Location. Alameda Location. The facilities (Alameda sub-acute, South Shore and Park Bridge Rehabilitation) are considered one location with one combined account.

KEY ROLES This policy lists the key roles and responsibilities to ensure there are controls in each facility location where there is a resident trust fund account. Key personnel roles and responsibilities are outlined including bank account set up, deposits and disbursement requirements, monthly accounting posting and account reconciliations and account maintenance.

The followings are the key personnel involved in ensuring the resident trust fund accounts are properly recorded and safeguarded: Social Services Designated Facility Representative Resident trust Custodian Facility Authorized Designee Long Term Care (LTC) Facility Manager Senior Accounting Analyst (Accounting Services Department) Bank Account Designated Signer Bank Account Authorized Signer

DUTIES OF RESPONSIBLE PERSONNEL Social Services: 1. Sets up each resident trust fund. Social Services should provide each resident with the handout on the Patient Financial & Legal Affairs Program. With a facility witness, the resident and/or responsibility party should sign a Memorandum form stating that they would like to open a patient trust account. If the resident is unable to sign due to physical limitations, an X mark beside the printed name will suffice. If the resident is mentally incapacitated, the next of kin, conservator or Durable Power of Attorney (DPOA) should sign the Memorandum. Example:

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Designated Facility Representative: 1. Receives the resident cash or check for deposit. When the form is signed, a check/cash needs to be given to open the account.  Once the cash/check is received, this is submitted to the Facility Authorized Designee for deposit.  All deposits should be supported by cash receipts as shown below:

2. Disburses cash to residents upon request, up to the resident’s account balance. This requires the resident or responsibility party’s signature and a facility witness. The Facility Authorized Designee should have individual ledger showing the fund balance available for each resident. Most of the residents withdraw all their Social Security Income (SSI, $51 in 2020) at the beginning of each month.

 If the requested amount is less than $50, Facility Authorized Designee contacts the Resident trust Custodian at the facility to get the fund from the resident trust fund “SAME DAY”. Request form will be completed as shown below. Documentation such as original receipt/invoice will be attached to the request. If not available at the time of the request, Facility Authorized Designed will follow up as soon as received and will be given to the Resident trust Custodian.

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213/288 SAME DAY means that if the request is for less than $50, it will be honored the same day.  If the requested amount is over $50, the Designated Facility Representative fills the check request form and includes the supporting documents (e.g., voucher, purchase receipts, invoices, bills) and sends it to the Facility Authorized Designee. Funds must be made available within three business days from the date of the request.

3. The Share of Cost is paid at the beginning of each month. If the facility is a Social Security representative payee, a check request should be made to transfer funds from the patient trust fund to the operating fund to pay the monthly share of cost. Transfer will be completed via the manual check request process.

4. When a resident passes away and still has remaining money in his/her fund account, the facility must surrender those funds to the individual managing the deceased estate within 30 days. The Designated Facility Representative will prepare a check request to the Facility Authorized Designee as soon available.

Upon the resident’s discharge, the full balance of funds belonging to the resident must be returned within 30 days from discharge date. The Designated Facility Representative will notify the resident or responsible party for the final full balance amount that will be returned to the resident in coordination with the Facility Authorized Designee for the amount subject for refund.

Resident Trust Custodian: 1. Receives, safekeeps and maintains resident trust fund - Resident trust funds are set up to provide a facility with a small amount of cash that can be accessed immediately for daily needs. Resident trust funds are set up at a monthly amount per facility as determined by Vice President, Finance and Chief Administrivia Officer (CAO), Post-Acute Care.

2. Resident trust disbursement for expenses up to $50. The general procedures for cash disbursement control are as follows:  Reimbursement in cash up to $50.  All cash disbursement must be supported by voucher with 3 signatures:  Authorized parties as approver  Cash disbursing officer  Cash recipient  Expenses must be signed by the authorized parties (provided that signatory authority has been granted). Supporting documents/receipts must be attached.  A cash disbursement can be made if the following applies:  Documents have the required approvals.  Disbursement is authorized purposes/expenses. For recurring expenses, there should be adequate documentation for the disbursement such as a cell phone bill for the specific month.

3. Prepares Resident trust Replenishment Request - every second week of each month a request to replenish resident trust fund is to be submitted to the Facility Authorized Designee, along with the receipts/documents that support the disbursement. A copy will be kept for record

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214/288 and all original will be sent to the Facility Authorized Designee.

Example:

Facility Authorized Designee: 1. Implements a cash ledger system to record each transaction daily. Maintains two types of records:

Individual Ledger The records should include the resident name, facility location, amount of cash withdrawn or deposited and the purpose (such as cash, purchase of clothing, haircut, telephone bill, etc.). The signature of the resident or the resident’s authorized representative should be required for each transaction in the disbursement voucher. In a case where a resident is unable to physically sign, an “x” mark is sufficient, granted the patient has the capacity to make financial decision. In case of incapacity to make financial decisions, the responsible party should sign or should have something in writing to authorize release of funds. The ledger should show the accurate and current balance each day.

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215/288 Example:

Consolidated Summary Worksheet Ledger A list of all residents who have a trust account in the facility and their records including location, cash deposit, resident trust withdrawals, check request and other related expenses. This ledger is summarized monthly and must be in balance to the general ledger book per account. Example:

2. Maintains the bank account for the facility location.

3. Prepares bank deposits per facility location and deposit to the bank.

4. Receives all checks and cash from all facility location through the Designated Facility Representative. The process is as follows:  Separates checks and cash received by facility location.  Makes two copies of all the checks and cash for record keeping purposes and General Ledger purposes.  Completes deposit slip and makes two copies for each account for record keeping purposes and General Ledger purposes.  Ensures checks received are stamped for deposit only.  Puts cash, checks and deposit slip in bank deposit envelope for deposit.

5. Keeps the inventory of checks for the facility location.

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216/288 6. Maintains check distribution log for all checks issued. Example:

7. Processes withdrawals, replenishes resident trust and issues checks per facility location.

Resident trust Replenishment – processes resident trust replenishment request from the 16th to the 30th of the month to allow time for verification of the account balance. Steps are as follows:  Resident trust Custodian requests via e-mail, with attached copy of the Resident trust Withdrawal log. and send the original yellow receipt via QIC to the Accounting Services Department.  Receives from intra mail (QIC) the original yellow receipt from Resident trust Custodian.  When receipt copies are received, matches total receipts and amount requested to the disbursement log. After verification, amounts disbursed are recorded to individual ledger by patient and in summary worksheet.  Issues the resident trust replenishment check payable to the Facility Administrator by location.  Once checks have been signed by designated signers, mails to the receiving party via QIC to the requestor. Example:

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8. Checks requested for other purposes/expenses. All check requests per facility location will received and process every 16th of the month except for other urgent reason. The form is shown below: Sample reasons for check request are as follows:  Patient being discharged  Payment for Share of Cost  Patient needs funds for personal purchases over $50

Example:

9. Records and allocates any interest earned and bank fees based on actual amount balance/earnings.

 POOLED ACCOUNTS: If pooled accounts are used, interest must be prorated per individual based on actual earnings.  INTEREST BEARING: Means a rate of return equal to or above the passbook savings rate at local banking institutions in the area.  BANK FEES: Residents cannot use their funds to pay for bank fees.

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218/288 10. Prepares quarterly statement report of personal funds for each resident. See sample statement below:

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219/288 Facility Manager: 1. Informs the residents of Costs for Services or any changes. 2. Notifies the residents who are Medicaid recipients when the balance is less than the SSI resource limit for one person. 3. Handles the resident fund upon the death of a resident within 30 days or if he/she choose to stop using a resident trust account. 4. Generates the Share of Cost Statement and sends it out the 1st day of the month to the Accounting Services Department for payment. 5. A Patient Trust Bond (or Nursing Home Bond) is a type of surety bond that guarantees patient trust funds are properly manage by the care facility. The facility manager ensures that the facility follows the California Department of Public Health’s rules and regulations.

Senior Accounting Analyst (Accounting Services Department): 1. Sets up a Resident Trust Fund bank account for each facility location. Each bank account combines all participating residents’ funds for each facility location. 2. Ensures compliance with trust agreements, regulatory guidelines and proper recording of receipts, payments, earned interest and bank fees distribution. 3. By the second business day of the month, receives all documentation of the previous month’s activities (e.g., deposits, receipts) from the Facility Authorized Designee for posting to the accounting system (Lawson). 4. Reviews the consolidated worksheet ledger maintained by Facility Authorized Designee and ensure that balances with Lawson general ledger. May use other tools such as EPIC if applicable. 5. Reconciles Lawson balance to bank balance for each facility location by the fifth business day of the month. 6. Follows guidance from the Government Accounting Standards Board (GASB).

Bank Account Designated Signer: The Bank Account Designated Signer is limited to signing checks only. The Facility Authorized Designee submits a disbursement voucher with documentation (original receipt, invoice or other document) to support a check request. The Designated Signer will review the voucher packet before signing and issuing a check to the resident.

Bank Account Authorized Signer: The Bank Account Authorized Signer is an executive authorized to (a) establish accounts, (b) enter into any agreements with the bank, and (c) designate persons to operate or close an account.

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220/288 APPROVALS

System Alameda AHS/Highland/John George/San Leandro Department Date: N/A 06/2020 06/2020 Pharmacy and Date: N/A N/A N/A Therapeutics (P&T) Clinical Practice Date: 06/2020 N/A N/A Council (CPC) Medical Executive Date: N/A 07/2020 07/2020 Committee Board of Trustees Date: N/A N/A

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SECURITY MANAGEMENT PLAN

Department Security Effective Date 03/2020 Campus AHS System Date Revised 05/2020 Category Security Next Scheduled 08/2023 Review Document Director of Security Executive Responsible Vice President, Support Owner Services Printed copies are for reference only. Please refer to electronic copy for the latest version.

PURPOSE The Board of Trustees oversees and reviews the development and implementation of the Environment of Care Security Management Program, in conjunction with the Vice President of Support Services and AHS Director of Security. Alameda County Sheriff’s Office (police services) and Allied Universal Security (AUS) provide security services to Alameda Health System-Highland Campus. AUS also provides security services in the following locations with the assistance of local law enforcement as needed.  Alameda Hospital & South Shore Rehabilitation – Alameda, CA  Eastmont Wellness – Oakland, CA  Fairmont Rehabilitation Center – San Leandro, CA  Hayward Wellness – Hayward, CA  John George Psychiatric Hospital – San Leandro, CA  Newark Wellness – Newark, CA  San Leandro Hospital – San Leandro, CA  Park Bridge Rehabilitation – Alameda, CA

The AHS Security Director and AUS Portfolio Manager works in collaboration with the following Law Enforcement Agencies on security-related issues.  Alameda County Sheriff’s Department (Highland Hospital, John George Psychiatric Hospital, and Fairmont Rehabilitation)  Alameda Police Department (Alameda Hospital, Park Bridge Rehabilitation, South Shore Rehabilitation)  Hayward Police Department (Hayward Wellness)  Newark Police Department (Newark Wellness)  Oakland Police Department (Eastmont Wellness)  San Leandro Police Department (San Leandro Hospital)

POLICY The purpose of the Security Management Plan is to support Alameda Health System’s goal of providing a safe and secure environment for patients, visitors, employees, volunteers, medical staff, and vendors. The purpose and mission of the Security Management Plan support the

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222/288 mission, vision, and values of Alameda Health System, as well as general safety policies and all regulatory requirements.

SCOPE The Security Management Plan applies to all Alameda Health System facilities, and all patients, visitors, employees, volunteers, medical staff, and vendors. The AHS Security Director and designated AUS Account Director and Managers oversee day-to-day security operations and communicate with as many departments and levels of the organization as needed to provide a reasonably safe and secure environment. Alameda Health System personnel and AUS Security personnel promote security protocols and general awareness. Alameda Health System employees are responsible for learning security-related policies and procedures and for reporting hazards and incidents.

Hours of Operations for the following campuses:  Highland Hospital (24 hours).  John George Psychiatric Hospital (24 hours).  Fairmont Rehabilitation and Wellness Center: a. B-building (24 hours) b. C-building (Monday-Friday, 7 am to 9 pm). c. H-building (Monday-Sunday, 7 am to 9 pm).  San Leandro Hospital (24 hours).  Alameda Hospital (24 hours).  Hayward Wellness (Monday- Saturday, 7:30 am to 5 pm).  Newark Wellness (Monday-Thursday, 10:30 am to 7 pm; Friday, 9 am to 5:30 pm; Saturday, 8 am to 4:30 pm).  Eastmont Wellness (Monday-Saturday, 7:30 am to 6 pm)  Park Bridge Rehabilitation (Monday-Sunday 8PM to 07:30 AM)

FUNDAMENTALS The fundamental mission of the Security Department is to provide security services to all persons, all properties, and to protect the interests of Alameda Health System through the efficient use of personnel, technology, prevention activities, and response to service requests.

OBJECTIVES The Security Management Plan is a risk reduction program designed to identify potential risks, assess possible corrective actions, and generally reduce property losses and potential personal injuries at the facilities. Security concerns and issues are addressed by: 1. Reporting and investigating all security incidents involving patients, visitors, personnel, or property.

2. Providing appropriate identification of patients, newborn infants, and their family members, employees, volunteers, medical staff, and vendors while on the campuses.

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223/288 3. Using Information, Collection, and Evaluation System (ICES). The following is reported to the EOC Committee: a) Security Incidents b) Security Conditions c) Police and community information and statistics d) Parking violations e) Investigations f) Basic activities and services

ORGANIZATION AND RESPONSIBILITY Alameda Health System leadership: 1. Supports and authorizes additional security measures for special circumstances such as domestic violence, gang-related activities, forensic patients, response to threats, and fire life safety incidents.

2. Evaluates the needs of local law enforcement and deploys appropriate numbers of Sheriff Deputies and security staff to support the mission and purpose of the Security Management Plan.

Security-Sensitive Area and AUS Security Leadership: 1. Collaboratively develop and implement an access control plan and the appropriate critical incident response plan(s) for each Security-Sensitive Area.

2. Consult and oversee annual employee training curriculum about each access control plan and critical incident response plans(s)

3. The AHS Security Director inspects, schedules preventive maintenance, and annually evaluates the effectiveness of security equipment.

Alameda Health System, AUS Security Leadership, and Alameda County Sheriff’s Office (Highland Campus) 1. Assess the appropriateness of declaring an area security-sensitive based on the potential for violence or use of weapons; especially vulnerable populations such as the elderly, infants, and children; the availability of drugs, money, and unsecured personal property; identification and access for visitors/employees in all areas of Alameda Health System.

Declare the following as security-sensitive a) Emergency Department (Alameda Hospital, Highland Hospital, San Leandro Hospital) b) Pharmacy (Alameda Hospital, Fairmont Hospital, Highland Hospital, John George, San Leandro Hospital) c) Family Birthing Center (Highland Hospital) d) Intensive Care Unit (Alameda Hospital, Highland Hospital, San Leandro Hospital) e) John George Psychiatric Hospital (Triage, PES, Unit B, Unit C, Unit D)

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2. Complete a Risk and Vulnerability Review including: a) Physical plant size, including current and planned changes, types of clientele, the volume of business, community setting. b) Community crime patterns, neighborhood patterns of change. c) Exterior lighting, landscaping, communication systems, and parking issues. d) Security program leadership, policies, procedures, functions, activities, staffing, and deployment. e) Physical and electronic security systems. f) The Joint Commission (TJC) Security-Sensitive Area(s) review.

3. Implement Security Policies and Procedures. The Alameda Health System Facility Security Orders provide policy, procedure, direction, and control for the Security Program. Each Facility Security Order is reviewed and, if necessary, revised annually. The Vice President, Support Services, approves the Facility Orders in writing.

4. Establish Security Management Plan through Alameda Health System’s Environment of Care Committee, which includes but not limited to: a) Security specific procedures that will support Alameda Health System’s policies. b) Identify Sheriff’s Deputies and/or security personnel will be obtained through Alameda County Sheriff’s Department (Highland Campus), AUS, and Alameda Health System’s manager(s) re-assignment of available Alameda Health System staff. c) Security staff implementing the AHS Critical Incident Response Plan.

5. Provide access to urgent care areas by facilitating emergency vehicle access to urgent care areas and fire lanes at the entrances and in the parking areas.

6. Appropriately identifies patients, staff, and other people entering the facilities.

7. Identifies and implements security procedures for very important patients or the media.

8. Identifies and implements infant and pediatric abduction prevention measures.

EDUCATION AUS Security Leadership provides: 1. Orientation and education of its staff and documents all training; The following training and competencies are required for the Security Team:  California Security License requirements.  Health Insurance Portability and Accountability Act.  Bloodborne Pathogen/Infection Control.  Emergency Medical Treatment and Active Labor Act (EMTALA)  Fire Response Protocols.  PPE to include the location of and proper don/doff procedures (OSHA)  Safety procedures.

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225/288  MRI Safety (OSHA).  Suicide Prevention: environmental risk factors, finding help in emergencies, overcoming stigmas relating to mental illness and suicidality, achieving a better understanding of behavioral health in general.  De-escalation and managing aggressive behavior.  Use of Force.  Customer Service.  Security Incident Response Procedures for the facility.  Lockdown procedures.  Emergency notification procedures.  Emergency communications procedures.  Securing a crime scene.

2. Competency-based AUS staff evaluations of initial, on-going, and special performance issues.

ALAMEDA HEALTH SYSTEM PROVIDES: 1. Department leadership accountability for new Alameda Health System employee orientation and annual employee education and documentation.

2. Information to Alameda Health System employees about the following topics. a) Identification Badges b) Security services phone number c) Reportable incidents (disturbances, patient, visitor, an employee lost/stolen property, suspicious people/items, smoking on the Alameda Health System campuses) d) Weapons e) Forensic Patients f) Access control i. Keys, cards, codes ii. Regular office hours and after-hours iii. Parking iv. Visitor passes v. Assistance alarm g) Securing personal items h) Infant abduction prevention and response i) Any department-specific security information.

SECURITY EVENT DOCUMENTATION Security incidents and conditions are reported quarterly and summarized statistically, by AUS for, the Vice President of Support Services. The Director of Security reports and makes recommendations to Alameda Health System Administration, various Department Leaders, and the Environment of Care Committee for further follow-up and/or improvement.

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PERFORMANCE MEASURES The following measures help Alameda Health System and security leaders identify changes in Alameda Health System’s security procedure and develop remedies for negative changes:  Program measures address preventive and compliance activities. a. EOC/Safety Performance Measures Monitor  Event measures address security incident reports, which identify trends in overall security happenings. b. Scalable Event Reports  Activity measures address routine security services and periodic testing of the responsiveness of security staff members.

When an adverse change occurs, the leaders assess the relative severity of the change and determine an appropriate response.

APPROVALS

System Alameda AHS/Highland/John George/San Leandro Department Date: N/A 05/2020 05/2020 Pharmacy and Date: N/A N/A N/A Therapeutics (P&T) Clinical Practice Date: 06/2020 N/A N/A Council (CPC) Medical Executive Date: N/A 07/2020 07/2020 Committee Board of Trustees Date: N/A N/A

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INFUSION PUMP POLICY

Department Nursing, Pharmacy, Effective Date 06/2020 Biomedical, UHS Campus AHS System Date Revised 08/2020 Category Patient Treatment Next Scheduled 09/2023 Services Review Document Owner Medication Safety Executive System Director, Pharmacy; Officer Responsible Chief Administrative Officer/ Chief Nurse Executive Printed copies are for reference only. Please refer to electronic copy for the latest version.

POLICY All licensed personnel who utilize infusion pumps within Alameda Health System will receive theory and hands on training for infusion pumps used in their departments during orientation and on implementation of any new infusion pump devices. Infusion pumps will be used as indicated per manufacturer guidelines.

PURPOSE To outline requirements for infusion pump training and utilization.

SCOPE This policy applies to all personnel who use infusion pumps such as Licensed Vocational Nurses with IV Certification, Registered Nurses, Anesthesiologists and Certified Registered Nurse Anesthetists , etc.

DEFINITIONS Infusion Pump: Mechanical device utilized for controlled intravenous or subcutaneous delivery of fluid, blood and blood products, medication, parenteral nutrition or the enteral administration of enteral feeding products and water.

Patient Controlled Analgesia (PCA): Patient self-administration of intravenous opioids/narcotics for pain control via an infusion pump. Examples of infusion pumps used for PCA include: Alaris PCA Pump.

Smart Pump: A mechanical device with advanced safety technology, comprehensive drug library and a system of alerts and safeguards to prevent errors related to infusion. Example: Alaris Pump

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228/288 Syringe Pump: Mechanical device utilized for controlled intravenous delivery of small volumes of fluid, blood and blood products, and medication, e.g. Alaris Syringe Pump.

Master Drug Library (MDL) - contains defined drug infusion parameters such as commonly used concentrations and dosing limits, hard and soft limits.

Dose Error Reduction Software (DERS) - A customized software program in the infusion device that reduces the risk of infusion related errors by incorporating hard and soft limits, multiple drug dose modes and starting dose rates and concentrations, each customized in a master drug library.

Basic Mode The use of the pump without using a drug specific library for the infusion of a medication

Hard & Soft Limits Lower Hard Limit (LHL): the lower limit that cannot be overridden. Lower Soft Limit (LSL): the lower limit that can be overridden Upper Soft Limit (USL): the upper limit that can be overridden Upper Hard Limit (UHL): the upper limit that cannot be overridden

PROCESS Training: 1. Upon initial hire each personnel will receive theoretical and hands on return demonstration training on the infusion pumps used in their departments. 2. Every personnel will receive training updates as required for practice changes and updates with relation to infusion pump devices. 3. Copies of competency checklists or quizzes are to be kept in the employee file. 4. Training will be updated as needed to address medication safety needs

Infusion Pumps will be utilized for: 1. Intravenous delivery of fluid, blood and blood products and medication via central venous access devices, e.g. subclavian, femoral, implanted ports, PICCs. 2. Intravenous delivery of Total Nutrient Additive (TNA) and Lipid Solutions 3. Intravenous delivery of vasoactive medication 4. Any fluid, blood and blood product or medication requiring controlled infusion rates or programs

The Nurse is responsible for: 1. Selection of the appropriate infusion pump based on fluid, blood/blood product, medication, parenteral or enteral product to be administered. 2. The safe programming of the infusion pump, including utilization of drug library if applicable to the pump utilized. 3. Referring to AHS approved electronic drug information for detailed information related to administration of any medication being infused. 4. Determining fluid and medication compatibility prior to infusing concurrently

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229/288 5. Performing independent double checks of programming as per the IV Medication Policies or as required by department or institution specific policy (e.g. high risk medication, PCA, Independent Double Check Policy). 6. Monitoring and documenting the infusion and patient’s response and expected outcome before, during and after infusions. Refer to Mosby for information related to monitoring patients receiving intravenous, subcutaneous or enteral administrations. 7. Monitoring pain, sedation and respiratory the status of patient during opioid administration. 8. Recording administration of medication and assessment of patient’s response to therapy on the appropriate patient health record form. 9. Notifying the receiving unit when transferring a patient of the need for an infusion pump. 10. Reporting any fluid or medication near misses or actual errors using the Midas Safety Alert System. 11. Removing malfunctioning pumps from service and notifying Biomedical Engineering.

Infusion Pump Cleaning, Maintenance and Repair: 1. Nursing shall remove visibly soiled debris from the pump before storing in the dirty/soiled utility room. 2. Sterile Processing Department shall be responsible for ensuring regular cleaning of infusion pumps, as described in the user guides or manual. 3. Sterile Processing Department will perform routine disinfection and inspection. 4. Routine maintenance of infusion pumps shall be managed by the Biomed Department.

Adverse Events and Near Misses 1. In the case of an adverse event or near miss due to a problem with the infusion pump, the pump, tubing, IV bags and medications should be sequestered. 2. A Safety Alert will be submitted with the details of the event including serial # and any patient harm.

Smart Pump Utilization: The following applies to the utilization of the Smart Pump. 1. Prior to Utilization of the Smart Pump and at each shift handover: a. The Nurse is responsible for checking the preventative maintenance tag which will be located on the side of the pump. b. If the pump does not have the appropriate preventative maintenance tag, the Nurse is responsible for obtaining another pump with the correct tag and removing the incorrect pump from service. c. The pump removed from service will be sent to Biomed for maintenance. 2. Dose Error Reduction Software and Drug Library Compliance: a. The Smart Pumps are programmed with a Master Drug Library (MDL) and Dose Error Reduction Software (DERS) that has been vetted and reviewed by System P&T for best practice and safety to reduce the potential for medication error. b. Drug names, concentrations, upper and lower limits are all preprogrammed for safety in the MDL. c. These drugs are sorted into the various “care areas” that would commonly require them for specific patient populations, e.g. critical care, Emergency Department.

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230/288 d. It is an expectation that Nurses are compliant with usage of the DERS and MDL when using the Infusion Pump. e. Nurses should primarily access the “Care Area” appropriate to the unit that they are working on. i. If the drug does not appear in the library for the care area in which they work, they will switch care areas in order to administer. 3. Basic Mode: a. Prior to running any medication or solution in basic mode the nurse must verify that the drug is not in the MDL. b. Once the drug is confirmed that it is not available in the MDL, the Nurse must get authorization from the charge nurse to use basic mode and an independent double check must be completed for any high risk drugs prior to initiating the infusion. c. Following the initiation of administration of any drug in basic mode the form Drug Library Feedback Change Request Form (See Appendix B) must be completed by the Nurse and nurse manager for the area and forwarded to Pharmacy. d. The Medication Safety Committee will assess compliance with MDL and DERS, and the use of Basic Mode is monitored on a quarterly basis. e. Trends and recommendations from this review of DERS and MDL compliance and use of Basic Mode will inform drug library updates and will be reported by the Medication Safety Committee, System Pharmacy and Therapeutics Committee (P&T) and through to the Clinical Practice Committee. 4. Soft limits: a. May be exceeded by selecting “yes” to override the alert. b. During the infusion, the dose or rate that is outside the soft limits will be displayed in red font on the pump screen. c. If a soft limit is hit when programming a medication ordered on an approved Preprinted Order Set, the physician does not need to be notified. d. If a soft limit is hit when programming a medication ordered that is not on an order set, the ordering physician shall be notified by the assigned nurse. e. Documentation should occur of the override on the Medication Administration Record (MAR). 5. Hard limits: a. May not be exceeded unless the ordering physician is contacted to provide a rationale for exceeding the hard limit. b. Nurse must document in MAR providers name and rational for hard limit override. c. Exceeding the hard limit requires the infusion to be given in Basic Mode.

Continuous Quality Improvement (CQI) and MDL Updates 1. The Medication Error Reduction Team (MERT) is responsible for monitoring usage of the DERS, MDL update recommendations, use of Basic Mode, soft and hard limit and doses reviews in the CQI reports. 2. Any requests to change the MDL shall be submitted to pharmacy through completion of Drug Library Feedback Change Request Form and will be reviewed by the Medication Error Reduction Team (MERT).

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231/288 3. Updates to the MDL must be developed for each medication or fluid with consultation from pharmacy, nurse leader, as well as the physician chief or designate of the department who will be utilizing that medication or fluid in the MDL. 4. A communication and education plan must be developed and accompany all proposed MDL updates. 5. Once approval received the Medication Error Reduction Team (MERT) will communicate the changes to System P&T. 6. The upload of the new version of the MDL shall be done at a time agreed upon by Clinical Practice Committee 7. Activation of an updated MDL on the pump configured to the network occurs automatically. This ensures that pumps within the fleet have the most clinically current information. The wireless pump automatically searches for updates, downloads and installs the MDL when powered on before programming, after the infusion is cleared, during sleep mode when powered off and plugged in.

REFERENCES 1. Manufacture’s Reference Manual: Directions for Use: Alaris System ( with Alaris PC Unit, Model 8015)

2. ISMP Proceedings from the ISMP Summit on the Use of Smart Infusion Pumps: Guidelines for Safe Implementation and Use 2009

APPROVALS

System Alameda AHS/Highland/John George/San Leandro Department Date: N/A 07/2020 07/2020 Pharmacy and Date: 08/2020 N/A N/A Therapeutics (P&T) Clinical Practice Date: 08/2020 N/A N/A Council (CPC) Medical Executive Date: N/A 08/2020 08/2020 Committee Board of Trustees Date: N/A N/A

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232/288 Data Set Change Request and Reporting Form. This form is to be completed in detail and submitted to Pharmacy.

Request Infusion Pump:  Alaris Pump  CME  NICU

Request Type: Please check all that apply.  Request for Drug/Fluid addition  Request to delete a drug/fluid for Guardrails  Request to change Guardrails limits  Report an issue

Drug/Medication Information:

1. Medication Name (generic): ______

2. Medication Name (Brand): ______

3. Flow: Is this a continuous or intermittent IV medication?  Continuous  Intermittent

4. Concentration: List the product strength and bag volumes if known:

______

5. Route: What is the usual rout of administration?  Central  Peripheral  Both

6. Dosage: Usual doses and infusion rates at which this medication is administered.

______

7. Profile : Pump Profile Change is requested on:  Critical Care  Med Surg  Oncology  Special Care  NICU

8. Protocols: Will different dosing protocols be needed? (if Yes, specify protocols)

______

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233/288 9. Policy and Procedure: Any change or impact to Policy and Procedures?  Yes  No

10. Reason why this change is needed?

______

______Printed Name of Requestor Date

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3 Highland COMBINED

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ANESTHESIA RESPONSE TO LEVEL 1 TRAUMA ACTIVATIONS

Department Trauma, Anesthesia Effective Date 08/2020 Campus Highland Hospital Date Revised 08/2020 Category Clinical Next Scheduled Review 09/2023 Document Owner Trauma Medical Executive Responsible Chief Medical Officer Director Printed copies are for reference only. Please refer to electronic copy for the latest version.

PURPOSE The purpose of this policy is to outline the attendance expectations for anesthesia providers for level 1 trauma resuscitations. Anesthesia providers provide a resource for emergency/challenging airways for critically injured patients. Additionally, by responding to trauma activations they can obtain advanced warning on emergency operative cases.

POLICY An anesthesia provider (anesthesiologist or certified registered nurse anesthetist) will respond to the Emergency Department trauma bay for all level 1 (top tier) trauma activations within 15 minutes of the patient’s arrival.

PROCEDURE The anesthesia provider’s presence will be recorded into the trauma narrator by either a) utilizing the badge-in laptops located in ED rooms 8 and 9 (preferred) or b) having the nurse recorder arrive them into the trauma narrator.

The Trauma Program staff will audit anesthesia presence with the goal of 50% compliance.

Anesthesia will be available to act as a resource for definitive airway placement and/or place difficult airways in collaboration with the ED airway team. Anesthesia will be aware of the patient’s resuscitation status from the time of arrival in order to increase efficiency, decrease miscommunication, and improve overall care of the trauma patient.

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System Alameda AHS/Highland/John George/San Leandro Department: Date: N/A N/A 07/2020 Pharmacy and Date: N/A N/A N/A Therapeutics (P&T) Clinical Practice Date: 08/2020 N/A N/A Council (CPC) Medical Executive Date: N/A N/A 08/2020 Committee Board of Trustees Date: N/A N/A

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Department Obstetrics, Family Effective Date 10/2005 Birthing Center Campus Highland Date Revised 03/2014, 04/2020 Category Clinical Next Scheduled 07/2023 Review Document Director, Family Birthing Executive Vice President, Patient Owner Center; Chair, Maternal Responsible Care Services Child Health Printed copies are for reference only. Please refer to electronic copy for the latest version.

PURPOSE To promote the safe and standardized placement of transvaginal cervical cerclage at the Family Birthing Center (FBC) in patients who are appropriate candidates.

POLICY Transvaginal cervical cerclage is placed according to established obstetric indications to prolong pregnancy by an obstetrician-gynecologist (OBGYN) physician or Maternal Fetal Medicine (MFM) physician in the Family Birthing Center.

1. Background Cervical cerclage refers to a variety of surgical procedures in which sutures, wires, or synthetic tape are used to reinforce the cervix. By mechanically increasing the tensile strength of the cervix, the occurrence of adverse perinatal events associated with cervical insufficiency may be reduced (UpToDate, 2020). Adverse perinatal events may include fetal loss or premature birth. Cervical insufficiency is described as a uterine cervix that is unable to retain a pregnancy with the absence of uterine contractions, labor, or both. It most commonly occurs in the second trimester of pregnancy (Elsevier Skills, 2019). Cervical cerclage is generally not performed before 12 weeks gestation or after fetal viability; however, absolute lower and upper limits of gestational age are not determined, and each case must be assessed and managed on an individual basis.

The transvaginal route is the only method of cervical cerclage performed at the FBC. Cervical cerclage is performed in one of the FBC’s dedicated operative suites according to usual regulatory requirements and operative practice. Cervical cerclage may be done on an outpatient or inpatient basis, dependent on the individual clinical features of each case.

2. Indications Indications include but are not limited to: a. History of one or more second-trimester pregnancy losses related to painless cervical dilation and in the absence of labor or placental abruption

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b. Prior cerclage due to painless cervical dilation in the second trimester c. Painless cervical dilation in the second trimester d. Current singleton pregnancy, prior spontaneous preterm birth prior to 34 weeks’ gestation, and a short cervical length (less than 25 mm) before 24 weeks’ gestation

3. Contraindications Contraindications include but are not limited to: a. Chorioamnionitis or intrauterine inflammation and infection (Triple I) b. Preterm prelabor rupture of membranes (PPROM) c. Active preterm labor d. Active vaginal bleeding

4. Complications Complications include but are not limited to: a. Cervical lacerations b. Rupture of membranes c. Chorioamnionitis d. Displacement of sutures

PROCEDURE (SEE ALSO: ELSEVIER SKILLS CERVICAL CERCLAGE (MATERNAL-NEWBORN) – CE) 1. Pre-procedure evaluation Prior to proceeding with cerclage, the physician makes a preoperative assessment including, but not limited to, the following: a. Fetal evaluation i. Cardiac activity ii. Gestational age iii. Structural anomalies iv. Results of aneuploidy screening, if available b. Infectious disease screening i. Results of chlamydia and gonorrhea screening and treatment, if any ii. Amniocentesis to confirm or rule out sub-clinical intrauterine infection is controversial and is generally limited to cases in which the cervix is dilated two or more centimeters and/or intrauterine infection is suspected. c. Membrane status PPROM is ruled out according to standard methods d. Labor status Preterm labor is ruled out prior to proceeding with cerclage placement

2. Pre- and Perioperative Care a. Diet: Scheduled cerclage patients are NPO for 2 hours immediately prior to procedure and on clear liquids for the 8 hours prior to that

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b. Antibiotic prophylaxis is not recommended due to insufficient evidence of benefit, including for women colonized with group B streptococcus c. Tocolytic medications are not recommended for first trimester cerclages due to a paucity of data. Indomethacin may be used intraoperatively and for up to 48 hours post-operatively in women undergoing second trimester cerclages, at the discretion of the physician, based on clinical presentation and indication for cerclage d. Either general or neuraxial anesthesia is acceptable during cerclage placement, depending on patient factors and patient preference. Neuraxial anesthesia is recommended over general anesthesia for most patients based on overall safety profile. When neuraxial anesthesia is used, spinal or combined spinal- epidural anesthesia is recommended. e. The bladder is emptied prior to initiating the procedure f. Careful vaginal preparation with an antiseptic solution may be done, although there is no strong evidence of benefit. Considerations include whether membranes are prolapsed through the cervix. g. The choice of procedure for transvaginal cerclage and number of sutures placed is based on general surgical principles and the operator's experience and preference h. All medical care is documented in the patient’s medical record

3. Nursing Care of the Cervical Cerclage Patient Nursing assessment and preparation, education of patient and family, perioperative and postoperative care, monitoring, and documentation are outlined in detail in Elsevier Skills Cervical Cerclage (Maternal-Newborn) – CE, available on the AHS intranet. All nursing care is documented in the patient’s medical record.

4. Postoperative Care (see also: AHS policies PACU ADMISSION ASSESSMENT AND REASSESSMENT and DISCHARGE OF PATIENTS FROM PACU, and Highland policy POST ANESTHESIA AND SEDATION DISCHARGE CRITERIA) a. Monitor fetal heart rate and uterine activity according to physician orders b. Assess patient for cramping and vaginal discharge; note odor, character, and consistency of vaginal discharge if present c. Assess vital signs per physician orders and in accordance with AHS post anesthesia policies and procedures d. Report immediately to physician: i. Fetal heart rate baseline less than 110 beats per minute or greater than 160 beats per minute ii. Maternal heart rate greater than 110 beats per minute or maternal temperature greater than 37.8 Celsius (100 Fahrenheit) iii. Excessive uterine activity, cramping, vaginal bleeding, or unusual vaginal discharge e. Administer tocolytics per physician order, if indicated f. Physician documents fetal heart rate and assessment of amniotic fluid prior to patient discharge

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5. Discharge Instructions a. Pelvic rest for one week following procedure (or up to 32-34 weeks gestation, depending on clinical scenario and physician recommendation) b. Call Labor and Delivery for unusual vaginal discharge, vaginal bleeding, excessive uterine activity, cramping, fever, low backache, expulsion of suture material c. Inform medical personnel that cerclage is present whenever hospitalized. d. Cerclage will be removed at 36+0 to 37+0 weeks, or immediately upon onset of preterm labor

REFERENCES 1. Cerclage for the management of cervical insufficiency. Practice Bulletin No. 142. American College of Obstetricians and Gynecologists. Obstet Gynecol 2014 (reaffirmed 2019);123:372–9.

2. Elsevier Skills Cervical Cerclage (Maternal-Newborn) – CE, June 2019. Retrieved Mar 13, 2020 from https://point-of-care.elsevierperformancemanager.com/skills/1204/extended- text?skillId=MN_079

3. Medley N, Vogel JP, Care A, Alfirevic Z. Interventions during pregnancy to prevent preterm birth: an overview of Cochrane systematic reviews. Cochrane Database of Systematic Reviews 2018, Issue 11. Art. No.: CD012505. DOI: 10.1002/14651858.CD012505.pub2.

4. Up to Date, Transvaginal Cervical Cerclage, February 2020. Retrieved Mar 13, 2020 from https://www.uptodate.com/contents/transvaginal-cervical- cerclage?search=incompetent%20cervix&topicRef=6774&source=see_link#H19

APPROVALS

System Alameda AHS/Highland/John George/San Leandro Department Date: N/A 04/2020 04/2020 Pharmacy and Date: N/A N/A N/A Therapeutics (P&T) Clinical Practice Date: 05/2020 N/A N/A Council (CPC) Medical Executive Date: N/A N/A 05/2020 Committee Board of Trustees Date: N/A N/A

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Department Intensive Care Effective Date 07/2020 Nursery/Pediatrics Campus Highland Hospital Date Revised 07/2020 Category Next Scheduled 09/2020 Review Document Chair, Pediatrics; Executive Vice President, Patient Owner Director, Family Birthing Responsible Care Services Center Printed copies are for reference only. Please refer to electronic copy for the latest version.

PURPOSE To promote safe and effective use of continuous distending positive airway pressure (CPAP) via the Fisher & Paykel Bubble system to the spontaneously breathing infant requiring respiratory support.

POLICY The Family Birthing Center utilizes bubble continuous positive airway pressure (BCPAP) to provide primary and post-intubation respiratory support to neonates who require it. BCPAP is initiated and overseen in the Intensive Care Nursery (ICN) per order of the attending pediatrician.

BACKGROUND BCPAP is a constant-flow variable pressure system that incorporates a standard nasal prong or mask interface attached to a dual-limb heated and humidified circuit. It is the least expensive system, is commonly used in level 2 and 3 neonatal care units, and is easy to initiate in the delivery room. Inspiratory flow is provided from a blended gas source while the expiratory side of the circuit is submersed into a water column. These low flows prevent buildup of back pressure in the system making it a safe application for neonates. The desired level of CPAP in cm H20 is determined by not only the depth of the tubing within the water column but also the amount of flow powering the system. Continuous bubbling requires a base flow rate of 4 to 8 L per minute depending on the type of system used. Bubble CPAP systems' characteristics vary, so careful attention to both the depth and the flow are important factors to consider. CPAP pressure is measured with a pressure manometer to determine the actual pressure delivered. Gas flow is responsible for bubbling in the circuit and produces mini oscillations generated within the chest that can equate to nearly 5 to 20 Hz at average CPAP levels (UpToDate, 2020).

Bubble CPAP creates pressure by placing the expiratory limb of the circuit into a column of liquid. The bubbling effect creates small airway pressure oscillations that are transmitted to the

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infant's chest, maintaining better lung inflation and improved gas exchange. It is also used to maintain a stable functional residual capacity (FRC), thus improving oxygenation, preventing atelectasis, and decreasing the work of breathing (Children’s Hospital and Research Center Oakland, 2015).

Indications Indications for BCPAP include, but are not limited to: 1. Respiratory distress syndrome (RDS)

2. Pulmonary edema

3. Atelectasis

4. Weaning from mechanical ventilation

5. Upper and/or lower airway obstruction

Contraindications Contraindications to BCPAP include, but are not limited to: 1. Pneumothorax

2. Congenital diaphragmatic hernia (CDH)

3. Need for mechanical ventilation due to respiratory failure

4. Tracheo-esophageal fistula (TEF)

5. Cleft palate

6. Choanal atresia

Clinical Considerations 1. Infants receiving Bubble NCPAP have increased risk of pneumothorax, pneumo- mediastinum, and interstitial emphysema.

2. High BCPAP may cause a reduction in cardiac output. As lung compliance improves, more positive pressure is transmitted to the mediastinum.

3. BCPAP may cause air swallowing and abdominal distention. An OG catheter may need to be inserted by the RN for stomach decompression.

4. It is common for patients to be agitated when prongs are first applied. This agitation usually subsides once the patient gets used to the prongs and the gas flow in the nares.

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5. Continuous bubbling must be present; there is no alarm to notify staff when there is a loss in pressure (possible causes: leak in the system usually from the mouth open, improper placement of the nasal interface) Chin straps are necessary to minimize leak.

Reducing Complications Pneumothorax can be avoided by reducing CPAP pressures as the lung compliance improves, which may be noted as an improvement in Sp02, oxygen requirement, and work of breathing. Close vigilance is required.

PROCEDURE (see also Elsevier Skills Ventilation: CPAP, NIPPV, and HFNC (Neonatal) – CE) Equipment 1. BC 163-10 Bubble CPAP system (Bubble generator w/ pressure manifold, circuit)

2. IV pole with oxygen blender

3. Flexi Trunk Infant Interface (Nasal Tubing 70mm length)

4. Fisher & Paykel Heater and Humidifier chamber

5. Appropriately sized bonnet/headgear (available in 8 sizes)

6. Appropriately sized nasal prongs (available in 10 sizes)

7. Appropriately sized nasal mask (available in 4 sizes)

8. Foam blocks (used for proper positioning of nasal mask)

9. Chin straps (available in 4 sizes)

10. Oxygen analyzer

11. Blankets to maintain neutral head position or proper positioning of BCPAP circuit

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Initiation 1. Physician's order for BCPAP must include the prescribed positive pressure level (cmH20) and desired Sp02 range.

2. Respiratory Technician (RT) sets up equipment and obtains nasal prongs, mask, and bonnet.

3. RT, with assistance from Registered Nurse (RN), measures the infant's nares and head to obtain the appropriate prong and bonnet size

4. Position i nfant in a developmentally supportive position

Preparation Perform Leak Test prior to applying BCPAP to patient: 1. Connect test elbow to expiratory and inspiratory limbs.

2. Check all connections are tight before use.

3. Set CPAP probe to 10 cmH20 and turn the flow to 1 Llmin.

4. Observe the CPAP generator. Gentle, audible bubbling is acceptable; no bubbling means an unacceptable leak.

5. If no bubbling is observed, check the entire system.

Fitting bonnet/headgear, prong and mask 1. Measure the patient's head circumference in centimeters to obtain the appropriately sized bonnet/headgear. Choose the correct sized bonnet. The bonnet should fit snugly. Stretch the bonnet with your hands initially for ease of placement.

2. Use the sizing guide to determine the appropriate size prong and mask. Ensure the prongs fill the nares but do not stretch the skin. E n s u r e t he mask does not touch the edge of the nose, septum, or eyes.

Operation (refer also to manufacturer’s product information/user manual) 1. Fill the Bubble Generator with sterile water until water flows into the overflow container. The water will then sit at the Fill Line.

2. Set the required Fi02.

3. Turn the flow to recommended 8 L per minute. (Allowable flow range: up to 15 L/min)

4. Set the CPAP by sliding the probe in or out. The number on the CPAP probe above the lid indicates the CPAP in cmH20. (Allowable CPAP: up to 10 cmH20)

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5. Turn the Fisher & Paykel heater on and let warm up before applying the interface to baby's nares. Apply a chin strip careful not to over tighten.

MAINTENANCE 1. Blanket and neck rolls may be utilized to maintain the head in a neutral position. The baby may be in prone position as well, once assured that there are no pressure points from the nasal prongs/mask interface.

2. When using a nasal mask, add a foam block so that the tubing does not pull back on the infant's nose.

3. Change and label all equipment disposables every 7 days, including circuit, prongs, mask, and bubble generator

4. Check the patient's nares every 2 hours or more often as needed for skin integrity. Report any redness, pressure points, or breakdown to pediatrician immediately. Document findings and nursing actions in patient’s medical record.

5. Give blow by breaks every 4 hours (if patient tolerates)

REFERENCES 1. Children’s Hospital & Research Center Oakland (2015). Respiratory Care Department: Bubble CPAP Protocol.

2. Elsevier Skills (2019). Ventilation: CPAP, NIPPV, and HFNC (Neonatal) - CE. Retrieved Mar 9, 2020 from https://point-of- care.elsevierperformancemanager.com/skills/10608/extended-text?skillId=NN_023

3. UpToDate (2020). Respiratory support, oxygen delivery, and oxygen monitoring in the newborn. Retrieved Mar 9, 2020 from https://www.uptodate.com/contents/respiratory- support-oxygen-delivery-and-oxygen-monitoring-in-the- newborn?search=cpap&source=search_result&selectedTitle=6~150&usage_type=default&di splay_rank=6#H705751490

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APPROVALS

System Alameda AHS/Highland/John George/San Leandro Department Date: N/A N/A 07/2020 Pharmacy and Date: N/A N/A N/A Therapeutics (P&T) Clinical Practice Date: 08/2020 N/A N/A Council (CPC) Medical Executive Date: N/A N/A 08/2020 Committee Board of Trustees Date: N/A N/A

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HIGHLAND OUTPATIENT PHARMACY DISCHARGE ORDERS AND ED DISCHARGE AUTO-SUBSTITUTION POLICY

Department Outpatient Pharmacy, ED, Effective Date 03/2014 Hospital Discharge Units Campus Highland Hospital Date Revised 07/2020 Category Outpatient Pharmacy, ED, Next Scheduled 09/2023 Hospital Discharge Units Review Document Manager, System Executive Chief Administrative Officer/ Owner Medication Safety Responsible Chief Nurse Executive Printed copies are for reference only. Please refer to electronic copy for the latest version.

PURPOSE Decrease calls to the emergency department and discharging providers for routinely prescribed medications that are not covered by insurance and therapeutic alternatives are available within the same medication class. This will in turn improve reimbursement of medications, improve patient adherence, and prevent gaps in treatment.

POLICY The Outpatient Pharmacy at the Highland campus will follow automatic substitution policy for prescriptions from Emergency Department and discharge providers for medications that are not covered and only when appropriate alternatives exist as approved by the P&T committee.

PROCEDURE 1. Upon receiving a prescription order for a medication that is not covered by the patient’s insurance, pharmacy will auto-substitute for an equivalent drug (dose and strength) that the patient’s insurance will cover. (see Attachment A)

2. A call to emergency department and discharging providers is not required for all approved drugs on this protocol list.

3. For a drug not on the pre-approved auto-substitution list, a provider must be notified of the drug not covered by the patient’s insurance and verbal confirmation from an ED provider/attending is required.

4. The pharmacist will note the date, time and auto-substitution on the prescription +/or software system (e.x: QS1, WAMB) including drug name, strength, sig., and quantity. If ED provider approval is needed for medications not on the auto-substitute list, the provider name will be documented on the prescription.

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248/288 5. If a provider prescribes insulin (vial and or pen formulation) and does not provide a prescription for syringes and or pen needles, the pharmacist will have prescribing authority to furnish a prescription for the provider.

6. If a provider prescribes and misses any diabetic supplies (ex: glucometer, test strips, lancets) to complete the order, the pharmacist will have prescribing authority to furnish prescription(s) for the missing supplies for the provider. However, if any further clarifications are needed such as missing directions, the provider must be contacted.

7. Patient will be notified if medication changes are made based on this auto-substitution policy.

APPROVALS

System Alameda AHS/Highland/John George/San Leandro Department Date: N/A 07/2020 Pharmacy and Date: 08/2020 N/A N/A Therapeutics (P&T) Clinical Practice Date: 08/2020 N/A N/A Council (CPC) Medical Executive Date: N/A N/A 08/2020 Committee Board of Trustees Date: N/A N/A

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249/288 Attachment A – Autosubstitution List Per P&T for ED Prescriptions Pharmacy and Therapeutics Committee Department of Pharmacy Services AHS Pharmacy will substitute with formulary drug based on patient's insurance

ACE-Inhibitor and Dose (PO) benazepril fosinopril lisinopril moexipril perindopril quinapril ramipril enalapril (Lotensin) (Monopril) (Prinivil/Zestril) (Univasc) (Aceon) (Accupril) (Altace) (Vasotec) 3.75 mg 1.25 mg 5 mg daily 5 mg daily 5 mg daily 2 mg daily 5 mg daily 5 mg daily daily daily 7.5 mg 10 mg 2.5 mg 10 mg daily 10 mg daily 10 mg daily 4 mg daily 10 mg daily daily daily daily 15 mg 20 mg 5 mg 20 mg daily 20 mg daily 20 mg daily 8 mg daily 20 mg daily daily daily daily 30 mg 40 mg 10 mg 40 mg daily 40 mg daily 40 mg daily 16 mg daily 20 mg BID daily daily daily 20 mg 40 mg BID 40 mg BID daily **All ACE inhibitors (except Monopril) require a 50% reduction in initial dosing for patients with ClCr <30 ml/min.

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250/288 Angiotensin Receptor Blocker (ARB) and Dose (PO) candesartan irbesartan olmesartan losartan telmisartan eprosartan valsartan (Diovan) (Atacand) (Avapro) (Benicar) (Cozaar) (Micardis) (Teveten) 40 mg daily 25 mg 400 mg 4 mg daily 75 mg daily 10 mg daily 40 mg daily (hypertension) or 20mg daily daily BID (hypertension) 80 mg daily 50 mg 600 mg 8 mg daily 150 mg daily 20 mg daily 40 mg daily (hypertension) or 40mg daily daily BID (heart failure) 1600 mg daily 100 mg 800 mg 16 mg daily 300 mg daily 40 mg daily 80 mg daily (hypertension) or 80mg daily daily BID (heart failure) 320 mg daily 800 mg 32 mg daily 300 mg daily 40 mg daily NA 80 mg daily (hypertension) or 160 daily mg BID (heart failure)

Alpha-1 Adrenergic Blocker and

Dose (PO) terazosin (Hytrin) doxazosin (Cardura) 1 mg QHS 1 mg QHS 2 mg QHS 2 mg QHS 5 mg QHS 4 mg QHS 10 mg QHS 8 mg QHS 20 mg QHS 8 mg QHS

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251/288 Antihistamine (Non-sedating) and Dose (PO) fexofenadine (Allergra) Cetirizine (Zyrtec) loratadine (Claritin) 30 mg Q12 5mg PO daily 5 mg daily 60mg PO q12h or 180mg PO daily 10mg PO daily 10mg PO daily

Antacid and Dose

(PO) Mylanta Maalox ES (Antacid Double Strength) 30 ml 15 ml

Antiplatelet Clopidogrel Prasugrel 75mg qday 10mg qday

Anticholinergic inhaler Atrovent inhaler Incruse Ellipta (umeclidinium) Spiriva inhaler All SIG *max dose 12 inh per day 1 puff (62.5 mcg) once daily 18mcg inh qday All SIG *max dose 12 inh per day

Calcium Channel Blocker and Dose (PO)

nifedipine felodipine (Plendil) amlodipine (Norvasc) (Adalat CC) 2.5 mg daily 30 mg daily 2.5 mg daily 5 mg daily 60 mg daily 5 mg daily 10 mg daily 90 mg daily 10 mg daily

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Carbonic Anhydrase Inhibitor and

Dose dorzolamide (Trusopt) brinzolamide (Azopt) 1 drop in affected eye(s) TID 1 drop in affected eye(s) TID

Calcium supplement and dose (PO) Calcium Gluconate 500 mg Calcium Gluconate 650 mg Calcium Carbonate 500 mg Calcium Carbonate 650 mg

H-2 Blocker and Dose nizatidine cimetidine (Tagamet) ranitidine (Zantac) (Axid) 300 mg PO q6h 400 mg PO 150 mg PO BID 150 mg PO BID q12h 300 mg PO daily 800 mg PO daily 300 mg PO daily 300 mg IV q6h 50 mg IV q8h **Famotidine dosing in renal dysfunction: Decrease dose to 20 mg daily for ClCr < 50 ml/min

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HMG-CoA Reductase Inhibitor

and Dose (PO) fluvastatin atorvastatin lovastatin rosuvastatin pravastatin simvastatin (Zocor) (Lescol) (Lipitor) (Mevacor) (Crestor) (Pravachol) 20 mg QHS 10 mg QHS 10 mg QHS 5 mg QHS

40 mg QHS 20 mg QHS 20 mg QHS 10 mg QHS

80 mg QHS 10 mg QHS 40 mg QHS 5 mg QHS 40 mg QHS 20 mg QHS

20 mg QHS 80 mg QHS 10 mg QHS 80 mg QHS 40 mg QHS

40 mg QHS 20 mg QHS 80 mg QHS

80 mg QHS 40 mg QHS

**Pravastatin is allowed when concurrently used with HIV or transplant medications or if a patient cannot tolerate simvastatin **Simvastatin 80 mg is limited to patients that have been taking this dose for >12 consecutive months and without evidence of myopathy **Common simvastatin DDI: CI with itraconazole, ketoconazole, posaconazole, erythromycin, clarithromycin, gemfibrozil, cyclosporine, HIV protease inhibitors. Not to exceed 10mg/d with amiodarone, verapamil, diltiazem. Not to exceed 20mg/d with amlodipine, ranolazine

Hydrocodone/acetaminophen and oxycodone/acetaminophen

For combination products hydrocodone/acetaminophen or oxycodone/acetaminophen; auto-substitution will only be made based on the APAP component to APAP 325mg (e.g. Oxycodone/APAP 7.5/500mg will be changed to Oxycodone/APAP 7.5/325mg)

Hydroxyzine 1:1 conversion Pamoate formulation hydrochloride form

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Insulin, short acting and Dose lispro (Humalog) aspart (Novolog) glulisine (Apidra) 10 units 10 units 10 units **this applies only for conversion from vials to vials and pens to pen BUT not vials to pens or vice versa

Regular insulin

OK to autobsub between brands or generic regular insulin

Long action insulin 1:1 conversion Insulin glargine (ok to autosub between Lantus and Basaglar as 1:1) Insulin Detemir

**if switching from vial to pens, can automatically dispense pen needles. When switching from pen to vials, can automatically dispense insulin syringes

Lispro insulin Admelog insulin 1 unit 1 unit **if switching from vial to pens, can automatically dispense pen needles. When switching from pen to vials, can automatically dispense insulin syringes

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Nasal Corticosteroids Beclomethasone (Beconase/Vancenase) 1 spray in each nostril BID-QID Beclomethasone AQ (Beconase AQ) 1-2 sprays in each nostril BID Flunisolide (Nasarel) 2 sprays in each nostril BID Triamcinolone (Nasacort, Nasacort AQ) 2 sprays in each nostril daily Fluticasone (Flonase) 2 sprays Budesonide (Rhinocort) 2 sprays in each nostril BID daily Budesonide AQ (Rhinocort AQ) 2 sprays in each nostril BID Ciclesonide (Zetonna) 1 spray in each nostril once daily Ciclesonide (Omnaris) 2 sprays in each nostril once daily Fluticasone Furoate (Veramyst) 2 sprays in each nostril once daily Mometasone (Nasonex) 2 sprays in each nostril once daily Beclomethasone (Qnasl) 2 sprays in each nostril once daily

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Inhaled Corticosteroid Budesonide Ciclesonide Fluticasone Fluticasone Fluticasone Fluticasone Mometasone Beclomethasone Mometasone DPI HFA HFA propionate propionate furoate HFA (QVAR) (Asmanex (Pulmicort (Alvesco) (Flovent DPI DPI DPI (Asmanex Twisthaler) Flexhaler) HFA) (Flovent (ArmonAir (Arnuity HFA) Diskus) RespiClick) Ellipta) 90 mcg 1-3 80 mcg 1 44 mcg 1-3 50 mcg 1-3 55 mcg 1 100 mcg 1 100 mcg 1 40mcg 1 inh 110 mcg 1 inhalations puff BID puffs BID inhalations inhalation inhalation inhalation BID inh QD BID OR BID BID QD BID 80mcg 1 inh OR OR 110 mcg 1 OR BID 220 mcg 1 180 mcg 1 puff BID 100 mcg 1 120mcg 1 inh inh QD inhalation inhalation BID BID BID

180 mcg 2- 160 mcg 1 110 mcg 2 100 mcg 2 113 mcg 1 N/A 200 mcg 1 160mcg 1 inh 220 mcg 1 3 puff BID puffs BID inhalations inhalation inhalation BID inh BID inhalations OR BID BID BID 240mcg 1 inh BID 220 mcg 1 OR BID puff BID 250 mcg 1 inhalation BID 180 mcg 4 160 mcg 2 220 mcg 2- 250 mcg 2- 200 mcg 1 200 mcg 2 320mcg 1 inh 220 mcg 2 inhalations puffs BID 4 4 inhalation inhalations BID inh BID BID puffs BID inhalations QD BID (total BID 232 mcg 1 440mcg per inhalation dose) BID

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Inhaled corticosteroid/ LABA Advair Advair HFS Airduo Fluticasone Symbicort Dulera Breo Ellipta Diskus Respiclick (aerosol powder)/salmeterol (Serevant Diskus) 100/50- 1 puff 45/21mcg – 55/14mcg- 1 100/50mcg-1 puff 80mcg/4.5mcg- 2 100/5mcg-2 100/25mcg- 1 BID 2 puffs BID puff BID bid puffs BID puffs BID puff qday 250/50- 1 puff 115/21– 2 113/14mcg- 1 250/50mcg-1 puff 80mcg/4.5mcg- 2 100/5mcg-2 100/25mcg- 1 BID puffs BID puff BID bid puffs BID puffs BID puff qday 500/50- 1 puff 230/21– 2 232/14mcg- 1 250- 2 puffs bid/50- 160mcg/4.5mcg- 2 200/5mcg-2 200/25mcg- 1 BID puffs BID puff BID 1 puff bid puffs BID puffs BID puff qday

**if pt's insurance does not cover any of the combo inhaler products, please call the physician. Can recommend to physician what patient's insurance will cover and take it as a verbal order if physician agrees to change the order

ondansetron ondansetron tab ODT tab OK to autobsub between regular and ODT tabs based on pt insurance coverage

Prostaglandin Agonist and Dose lantanoprost (Xalatan) 1 drop in affected eye(s) QHS bimatoprost (Lumigan) 1 drop in affected eye(s) QHS travoprost (Travatan) 1 drop in affected eye(s) QHS

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Proton Pump

Inhibitor and Dose pantoprazole lansoprazole omeprazole rabeprazole esomeprazole (Nexium) (Protonix) (Prevacid) (Prilosec) (Aciphex) 20 mg daily 15 mg daily 20 mg daily 20 mg daily 20 mg daily 40 mg daily 30 mg daily 40 mg daily 40 mg daily 20 mg BID 40 mg daily 40 mg BID 30 mg BID 40 mg BID

Miscellaneous Therapeutic Drug Conversions Timolol ophthalmic 0.5%- 1 drop BID Metipranolol 1 drop BID Ortho-dienestrol vaginal cream Premarin vaginal cream Cardizem CD Dilacor XR (same dose) Colestipol 5 gm Cholestyramine 4 gm Ciprofloxacin eye drop Ofloxacin eye drop Tobramycin eye oint Gentamicin eye oint Flurbiprofen eye drop Ketorolac eye drop Miconazole vag. Cream Clotrimazole vag. Cream Neosporin topical oint Polysporin topical oint (Double antibiotic oint)

SABA inhalers 1:1 conversion Albuterol HFA Levalbuterol HFA

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Serotonin 5-HT3 Receptor Antagonist dolasetron (Anzemet) ondasetron (Zofran) 12.5 mg IV/PO q6h 4 mg IV/PO q6h

Steroid Nasal Inhaler and Dose (per

Nostril) Beconase/Vancenase 1 spray BID-QID Beconase AQ 1-2 sprays BID Nasarel 2 sprays BID Flonase 2 sprays daily (non-Medical pts) Nasacort 2 sprays daily OR Veramyst 2 sprays daily (medical pts) Nasacort AQ 2 sprays daily Nasonex 2 sprays daily Triamcinolone [Nasacort AQ] 2 sprays Rhinocort 2 sprays BID daily (for Medical pts) Rhinocort AQ 1 spray daily Vancenase AQ 1-2 sprays daily

Sulfonylureas* Glyburide Glipizide 1.25 mg/day 2.5 mg/day 2.5 mg/day 5 mg/day 5 mg/day 10 mg/day

10 mg/day 20 mg/day (divided in 2 doses)

20 mg/day 40 mg/day (divided in 2 doses) *autosub glyburide to glipizide only

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260/288 Tetracycline Doxycycline Doxycycline

hyclate monohydrate 100mg BID 100mg BID

Thiazolidinedione and Dose (PO) rosiglitazone (Avandia) pioglitazone (Actos) 4 mg daily 15 mg daily 8 mg daily 30 mg daily (2x15 mg)

Combination antibiotics/steroid ear drops Ofloxacin 0.3% ear drops: 10 drops to affected ear(s) daily for 7 days AND Dexamethasone 0.1% EYE drops: 3 drops to the EAR(s) BID for 7 days

OR Ciprodex ear drop Ofloxacin 0.3% ear drops: 10 drops to affected ear(s) daily for 7 days AND Prednisolone 1% EYE drops: 2 gtts to affected EAR(s) BID for 7 days

Ofloxacin 0.3% ear drops: 10 drops to affected ear(s) daily for 7 days AND Dexamethasone 0.1% EYE drops: 3 drops to the EAR(s) BID for 7 days

OR Cipro HC ear drop

Ofloxacin 0.3% ear drops: 10 drops to affected ear(s) daily for 7 days AND Prednisolone 1% EYE drops: 2 gtts to affected EAR(s) BID for 7 days

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Docusate conversion between different salt forms

Docusate Ca 240mg Docusate Na 250mg

Tiotropium inhaler form interchanges Spiriva HandiHaler vs. Spiriva Respimat

Spiriva HandiHaler 1 capsule (18mcg) inhaled once daily Spiriva Respimat 2 inhalations (5mcg) once daily

Sevelamer conversion between different salt forms

Sevelamer carbonate 800mg Sevelamer HCL 800mg

Advair HFS (2 puffs BID) Advair Diskus (1 puff BID) 45/21 100/50 115/21 250/50 230/21 500/50

Sevelamer conversion between different salt forms

Sevelamer carbonate 800mg Sevelamer HCL 800mg

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TRAUMA ASSESSMENT AND SCREENING POLICY

Department Care Management, Effective Date 01/2019 Trauma Campus Highland Hospital Date Revised 08/2020 Category Clinical Next Scheduled 09/2023 Review Document Owner Director, Care Executive Vice President, Care Management Responsible Management Printed copies are for reference only. Please refer to electronic copy for the latest version.

PURPOSE The purpose of this policy is to provide a trauma informed mechanism effectively and compassionately address AHS patients who experience trauma. Furthermore, the goal of this policy is to promote the understanding of trauma and its impact, and to provide trauma informed treatment and services in a systematic way throughout the AHS facilities.

REGULATORY REQUIREMENT  American College of Surgeons (ACS) requires Level I and II Trauma Centers to conduct Trauma Prevention/Intervention Assessments, Screenings and Referrals.  AHS Highland Hospital will adhere to the ACS mandatory requirements such as Alcohol Screening, Brief Intervention, Referral and Treatment Program; Post Traumatic Stress Disorder & Trauma Violence Intervention

POLICY The AHS Care Management Department will identify patients who have experienced a traumatic injury and provide the required screening, interventions, and community referrals as outlined by the American College of Surgeons (ACS). It is the policy of AHS Care Management to provide such services through the development of a trauma informed system of assessment and referral of all trauma activated patients entering AHS facilities. A trauma informed response will include:  Screening for patients who have experienced traumatic injury  The use of trauma specific assessment tools for screening  The use of trauma specific services for referrals for intervention and treatment as needed  The adoption of a trauma informed culture that recognizes the importance of responding to trauma and the prevention on re-traumatization

PROCEDURE 1. Trauma Screening/Confidential Patient Process: In compliance with the AHS Level 1 trauma certification, Social Workers are the designated staff to complete the trauma screening for all patients designated with a trauma status. (see Trauma Screening, Referral and Documentation guidelines)

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263/288 a. Screening and documentation process begin when a trauma patient enters the emergency department – if patient is unable to engage in screening, so state in the documentation b. All Inpatient Social Workers are to review and complete trauma screenings for all new patients admitted to an inpatient unit if found to be incomplete or requires updating. This must occur within 24 hours of inpatient admission.  Any intervention including brief intervention (crisis or supportive counseling), referral to in-house or community organizations upon patient consent must be documented in Progress Notes  Any declination of services offered must be documented in the Progress Notes c. All SWs are responsible to initiate and manage the Opt Out Visitors process with the patient and designated family members as indicated; process often starts in the ED. Confirm patient is listed and designated as a Confidential Patient.

The screening tools to be completed include a. Alcohol abuse using the Screening, Brief Intervention, and Referral to Treatment (SBIRT) tool. b. Post-Traumatic Stress Disorder (PTSD), c. Violence Intervention.

REFERENCES 1. SBIRT (2019) https://www.integration.samhsa.gov/clinical-practice/sbirt

2. PTSD (2015) https://www.ptsd.va.gov/professional/assessment/documents/pc-ptsd5- screen.pdf

APPROVALS

System Alameda AHS/Highland/John George/San Leandro Department Date: N/A 08/2020 08/2020 Pharmacy and Date: N/A N/A N/A Therapeutics (P&T) Clinical Practice Date: 08/2020 N/A N/A Council (CPC) Medical Executive Date: N/A N/A 08/2020 Committee Board of Trustees Date: N/A N/A

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4 San Leandro COMBINED

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INTRAVENOUS ADMIXTURE SERVICE (SLH)

Department Pharmacy Effective Date 06/2013 Campus San Leandro Hospital Date Revised 6/2013, 2/2016, 10/2017, 07/2018, 09/2018, 04/2019; 07/2020 Category Pharmacy Next Scheduled 09/2023 Review Document Owner Director of Pharmacy; Executive Responsible Chief Administrative Manager, Medication Officer/Chief Nurse Safety Executive Printed copies are for reference only. Please refer to electronic copy for the latest version.

PURPOSE To ensure the quality, safety, and regulatory compliance of all intravenous solutions administered to patients at the facility.

POLICY The pharmacy department will follow the guidelines, standards, and requirements for compounded sterile products (CSPs) established by the United States Pharmacopeia (USP) – Chapter 797 and the American Society of Health-System Pharmacists (ASHP) in accordance with Federal and State pharmacy laws and regulations.

PROCEDURE 1. Ordering a. The Pharmacy will prepare any intravenous fluids with additives not available in pre- mixed form and will supply additives for piggyback medications upon receipt of an authorized order from the physician. The pharmacist will interpret the order and check for incompatibility, instability, contraindications and patient allergies. If clarification of the order is needed, the pharmacist will call the ordering physician, notify nursing of clarifications or changes and ensure that the clarification or change is in the patient’s chart. b. Exceptions: i. ICU, Surgery, and Emergency Department nurses may prepare cardiac medications (such as Lidocaine, Dopamine, Nitroglycerin, Nitroprusside, etc.) as needed and if not available as a premix. ii. Nursing Supervisors may prepare initial doses of IV solutions, as needed, when stock is available and the pharmacy is closed. (After hours procedures for nurses outlined below.)

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266/288 2. Compounding a. Keep traffic around the hood to a minimum. Organize work before starting to fill IV orders: i. Place the product label(s) for only one type of product in a basket with the ingredients needed to compound it. ii. Organize several baskets of labels and ingredients on the counter in IV room. iii. Bring the contents of only one basket into the compounding aseptic isolator (CAI) at a time. Only one type of drug product may be prepared in the CAI at a time. b. Jewelry is removed and the hands and forearms washed. See policy SLH Hand Hygiene. If employee leaves the CAI to perform another task, rewash hands before resuming work in the CAI. c. Before beginning work in the CAI, put on sterile, powder-free gloves. Sanitize the gloves by applying 70% “persistent activity” isopropyl alcohol and allowing it to dry. If leaving the IV room, discard gloves and put on new gloves before resuming work in the CAI. d. For procedure for using the CAI, see policy Use of the Germfree Compounding Aseptic Isolator (CAI or Glovebox.) e. All compounding of IV admixtures will be done using aseptic technique. Sterile compounding is done in CAI except in certain circumstances (i.e. after hours preparation). The hood provides a clean environment in which to work, filtering particles as small as 0.3 microns with 99.7% efficiency. The counter top, sides of the hood and human hands are not sterile. Care must be exercised at all times to avoid touching sterile IV needles, bottles, etc. to contaminated areas. If there is any doubt about the sterility of any item, it must be discarded. f. Items used in the hood are kept in direct airflow to minimize the chance of airborne contamination. Do not touch any area on the IV container, syringe or needle that is considered to be and/or must be maintained as, sterile or comes in contact with solutions. Touch contamination is the most common break in aseptic technique. g. Keep unnecessary items out of the hood. Keep the area free of spilled medications. h. Bags and bottles will be inspected prior to use for particulate matter, cracks, broken seals or other obvious damage. Defective material associated with improper manufacture will be held for the manufacturer’s representative. Completed admixtures will be checked for particulate matter, precipitation, or unexpected color changes by a pharmacist. i. If a person scheduled for IV preparation has an open cut or sore, upper respiratory tract infection, or other obvious potential for contaminating IVs they will be relieved of IV duty until the problem is resolved or the source of contamination is isolated (i.e. gloves, mask, etc). j. Label product immediately after removal from the CAI.

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267/288 3. Garbing, gloving, and hand hygiene techniques The proper garbing, gloving and hand hygiene procedures and steps as below (References: Article 4.5 of Division 17 of Title 16 of the California Code of Regulations, 1751.5. Sterile Injectable Compounding Attire & 1751.4(b). Facility and Equipment Standards for Sterile Injectable Compounding 1) Don shoe cover 2) Head and facial hair cover 3) Face mask 4) Hand washing and drying a. Remove debris from underneath fingernails, if present, using a nail cleaner under warm running water b. Wash hands and forearms up to the elbows with unscented soap and water for at least 30 seconds c. Dry hands and forearms to the elbows completely with low lint disposable towels or wipes d. Allow hands to dry thoroughly 5) Donning a non-shedding gown 6) Hand cleansing with a sterile 70 percent isopropyl alcohol offers “persistent activity”. (On 9/21/2018 Infection Disease Committee approved Purell 70% IPA Surgical Scrub formula is compliant with USP 797 and offers “persistent activity” to kill germs on hand hygience prior to donning gloves) 7) Donning a pair of sterile gloves 8) Gloves are to be routinely disinfected with sterile 70 percent “persistent activity”. isopropyl alcohol before entering or re-entering the PEC and after contact with non- sterile objects. Gloves shall also be routinely inspected for holes, punctures, or tears and replaced immediately if such are detected. 9) Individuals experiencing exposed rashes, sunburn, weeping sores, conjunctivitis, active respiratory infections or other communicable disease, or those wearing cosmetics, nail polish, or artificial nails shall be excluded from the ISO Class 5 and segregated compounding areas until their conditions are remedied.

4. Compounding Techniques a. Measuring Drugs with a Syringe: i. To attach the needle to the syringe:  Remove the syringe from its packaging.  If no needle is attached, do not lay the syringe down and do not touch the tip.  Remove the needle from its packaging.  Insert the tip of the syringe into the needle hub and turn the needle until tight.  Do not touch the hub of the needle.  Leave the needle guard in place until ready to use, to remove the guard, push the needle on and pull the guard straight off.  To remove the needle from the syringe, insert the needle into the guard and twist.

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268/288  When pulling back the plunger of the syringe, the fingers should not come into contact with any part of the plunger except the flat knob at the end.  The barrel of the syringe should be held in one hand and the flat knob of the plunger should be held with the index finger and thumb of the other hand.  Contamination of the medication can occur in some procedures if the plunger is touched with the fingers. ii. To remove air bubbles from the syringe:  Hold the syringe in a vertical position so that the needle is pointing upward.  Pull the plunger back a short distance so that some air enters the syringe.  Gently tap the barrel of the syringe with the fingers so that any air bubbles clinging to the sides are freed and float to the top of the solution.  Expel all of the air in the syringe by slowly pushing the plunger in until the solution is at the tip of the barrel.  Read the volume of the solution by aligning the rubber end of the plunger with the graduation marks on the barrel of the syringe. b. Using Ampules of Drugs: i. A colored stripe around the neck of an ampule indicates that the neck has been weakened to facilitate opening. ii. Hold the ampoule upright and tap the top to remove any solution there. iii. Swab the neck of the ampoule with an alcohol pad to reduce contamination. Leave the alcohol pad around the neck of the ampule to protect your fingers and grasp the ampoule on each side of the neck with the thumb and index finger of each hand. iv. Quickly snap the ampule. If it does not snap easily, rotate it slightly so that the pressure is exerted at a weaker point. v. Inspect for any particles that may have fallen into the solution. vi. To withdraw the drug and transfer to an I.V. solution:  Tilt the ampoule to a 20-degree angle.  Insert the needle into the ampoule taking care not to let the needlepoint touch the ampoule around the neck where it was broken.  Position the needle so that its opening is downward and the point is toward the bottom of the ampoule and withdraw the fluid. Do not put the needle to the bottom of the ampoule initially but follow the solution down as the level decreases.  Remove the needle from the syringe and discard.  Attach a 5-micron filter needle or filter and the needle to the syringe aseptically, then add the drug to the I.V.  If using several ampules for one preparation, draw all up and then attach the filter.

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269/288 c. Transfer of Drugs From Vials: i. Reconstitution:  Diluents such as sterile water for injection, bacteriostatic water for injection and 0.9% sodium chloride injection usually are used.  Volume of a suitable diluent is specified in the package insert and frequently on a vial itself.  Final volume of a reconstituted drug probably will be greater than the volume of diluent added because the drug itself occupies space in the solution (e.g., 1gm cefazolin reconstituted with 4mL diluent yields a final volume of 4.4mL. increased volume must be taken into account if the order is indicated for a fraction of a vial or an incorrect amount of drug will be used). ii. Transfer:  Remove the protective cap and swab the top surface of the rubber closure with an alcohol pad.  Determine the correct volume of suitable diluent, draw up the required amount into the syringe and expel all air bubbles  Inject the diluent into the medication vial.  Hold the inverted vial and barrel of the syringe in one hand and shake the vial without removing the needle until the drug is dissolved.  Withdraw the drug into the syringe.  If the entire contents are not to be withdrawn, remove air bubbles and measure the exact dose. iii. Piercing the rubber stopper:  Some are thin, soft, and pliable while others are thick, hard, and brittle. Cores from the latter are more prevalent.  When inserting the needle, lay the needle on the surface of the rubber closure so that the bevel of the needle is facing upward.  Push the needle downward while rotating it at the point to an angle of 45 degrees until the rubber closure is penetrated. iv. Withdrawing a solution from a vial:  Swab the rubber closure of the vial.  Inject the same volume of air as the volume of solution to be withdrawn.  Removal of solution from a closed vial may be difficult unless air is injected prior to removal of solution to avoid creating a vacuum within the vial.  Open vials with or without preservative must be dated and initialed and stored in the refrigerator. Those without a preservative must be used within 24 hours. v. Needle disposal:  Sharps (including needles and syringes) will be disposed of in impervious labeled containers.

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270/288 5. Beyond Use (Expiration) Dating a. Beyond use dates will be based on USP 797 guidelines or chemical and physical stability, whichever is shorter. The dates will be supported by manufacturer’s recommendations, references such as Micromedex or UpToDate, or published studies. b. USP 797 beyond use date guidelines: Risk Level Characteristics Beyond use date Immediate use  Made using no more than  Unless immediately three sterile products and administered, must be no more than two entries labeled with BUD of 1 into a sterile bag or vial. hour from the time  Aseptic technique must preparation began. be used.  If administration is not  The compounding started within one hour, the process cannot be longer product must be discarded. than one hour and there can be no delays or disruptions. Low risk  Prepared in compounding No more than: aseptic isolator.  48 hours at controlled  Made using no more than room temperature three sterile products and  14 days refrigerated no more than two entries  45 days frozen into a sterile bag or vial Examples: Single dose vials of antibiotics; small volume parenterals Medium risk  Involves multiple sterile No more than: products, complex  30 hours at controlled aseptic manipulations, or room temperature a long duration to  9 days refrigerated prepare.  45 days frozen Examples: TPNs; batch preparations

6. Checking: a. For doses using partial vials of drugs, after the drugs are drawn into syringes in the hood, the Technician will call for an “IV Check”, and a pharmacist will verify drug type and quantity to be used prior to actual mixing taking place. b. If the total volume of a drug vial is used for a dose, the Technician will place the finished admixed product and the empty vials used in a basket for the pharmacist to check. c. A pharmacist, noting the fluid, additive(s), volume and expiration date, will then check all IV admixtures prepared by the technician and record approval in the compounding log.

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271/288 7. Cleaning Procedures a. FOR EVERYONE entering segregated compounding area (IV room) i. Garbing gown and shoe cover must be donned upon entry to the room ii. Additional covers must be worn to enter “critical care area” (beyond demarcation line): head/facial hair cover and face mask (along with garbing gown and shoe cover) iii. Remove outer jackets and jewelry prior to entering IV room iv. Use proper hand hygiene by thoroughly washing hands, nails, and arms up to elbow with antiseptic agent and wash with water for 30 seconds and dry with non-shedding cloth. Allow hands to fully dry and put on sterile gloves and spray 70% “persistent activity”. IPA b. FOR EVS STAFF cleaning segregated compounding area (IV room) i. Initially remove loose materials and residues with either sterile water or wipes, followed by disinfecting agent with 70% “persistent activity” IPA and let it sit for at least 30 seconds ii. Clean from farthest corner back towards front door, from cleanest to dirtiest areas, and should clean walls from top to bottom iii. Use overlapping, unidirectional strokes with non-shedding material iv. For Oxivir solutions, let dwell for AT LEAST FIVE minutes before cleaning and for isopropyl alcohol let it sit for AT LEAST 30 sec v. Clean DAILY for: 1. Sinks- Emeral Cream cleaner 2. Counter tops- Oxivir 1 wipe(germicidal) 3. Floor- Oxivir Five 16 (germicidal) 4. Any work surface area (OUTSIDE of hood)- Oxivir 1 wipe 5. Waste removal 6. Backroom area- Oxivir 1 wipe and Oxivir Five 16 for floor vi. Clean WEEKLY for: 1. Ceilings (including grates/ vents/ light fixture)- Oxivir Five 16 2. Walls and fixtures (including shelving/ carts)- Oxivir Five 16 3. Additional surface (top of hoods/ cabinets/ furnitures)- Oxivir 1 wipes 4. Cleaning of waste bin INSIDE and OUTSIDE- Oxivir 1 wipes 5. Floor- PeridoxRTU (sporicidal) vii. Log all the cleaning activities inside IV room binder under EVS tab c. FOR PHARMACY STAFF in IV room i. Frequent cleaning for Aseptic Isolator Hoods (CAIs) 1. Use primary engineering controls in cleaning/ disinfecting surfaces for aseptic isolator hood (CAIs) with sterile 70% “persistent activity” Isopropyl alcohol (IPA) and dwell for at least 30 seconds  Beginning of each work shift  Before each batch preparation start  Every 30 min during continuous compounding periods of individual CSPs (does not have to be documented as long

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272/288 as frequent disinfection is noted in protocol and during competency)  When there are spills  Surface contamination is known or suspected from breaches ii. Daily and weekly activities for pharmacy staff for hoods 1. Moisten non-shedding wipe with sterile water to remove residue or spills prior to cleaning 2. DAILY, use Sani-cloth AF3 wipe (germicidal agent) and let dwell for 5 min then clean with IPA and let dwell for 30 sec before using the hood 3. WEEKLY (hood terminal cleaning*), clean with PeridoxRTU (sporicidal agent) and let dwell for 3 min then clean sterile water, then with IPA and let dwell for 30 sec before using the hood iii. Log all the cleaning activities inside IV room binder

8. Parenteral Nutrition Solutions: See policy Parenteral Nutrition, Interdisciplinary Monitoring and Administration of Patients On.

9. After Hours Preparation/Nursing Role in Admixture Preparation: a. When the pharmacy is closed the following procedure will be followed: i. The Nursing Supervisor will obtain and sign out the necessary IV medication(s) and special IV fluids from the Night Locker. Large volume IVs are obtained from floor stock. ii. Parenteral nutrition and other complex IV admixtures will not be prepared by the supervisor when the pharmacy is closed. The supervisor will call the on-call pharmacist to prepare them, if deemed an emergency. iii. The supervisor will prepare the admixture using the appropriate aseptic technique. The product must be double checked by a second nurse. iv. All IVs prepared at the nursing station should be prepared immediately before administration to reduce possibility of microbial contamination. b. Nursing personnel will follow policy for compounding I.V. admixtures and aseptic technique. The following precautions should be taken to enhance sterility of the admixed products. v. Work should be performed in a CLEAN area out of traffic flow. vi. All materials should be placed on a 4x4 sterile gauze pad. vii. All containers should be wiped with an alcohol prep pad. viii. Do not allow the needle or syringe plunger to contact ANY non-sterile areas. ix. Admixed products will be labeled per labeling policy. x. If any questions arise as to reconstitution, stability, or infusion rate, the pharmacist on call should be contacted.

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273/288 10. Pharmacy Personnel Training and Evaluation in Aseptic Manipulation Skills a. All personnel who prepare CSPs will complete appropriate training initially and annually. b. For new hires, 3 fingertip tests must be completed/passed prior to compounding any products for patient use. The process as follow: immediately following the initial hand hygiene and garbing procedure, the new hire who may be required to do so in practice must successfully complete a gloved fingertip (all fingers on both hands) sampling procedure (zero colony forming units for both hands) at least three times before initially being allowed to compound sterile drug preparations. c. Before assignment to compounding activities and at least annually, personnel who prepare CSPs will demonstrate competency by completing: i. Didactic coursework, AHS pharmaceutical calculations and competency examination. The examination questions will be updated annually. Employee must score 100% to pass. ii. Media fill testing for aseptic manipulation skills  The employee prepares a sample product using PATT2 Personal Aseptic Technique Test.  The sample product is incubated for 14 days at 20-25º C.  After 14 days, the sample product is examined for turbidity. If turbidity is observed, growth from microorganisms is indicated and the test is positive. If the sample product is clear, the test is negative and the employee has passed. iii. Observation: During the media fill test, the employee’s sterile technique is validated by observation by another staff member training in compounding sterile products. iv. Fingertip glove testing  After preparing the PATT2 sample product in part ii, the employee samples the glove fingertips using EnviroTest Media Paddle.  The media paddle is incubated at 30-35º C for 72 hours.  After 72 hours, the paddle is examined under good lighting. To pass, the paddle must have no colony forming units. d. Any employee who fails the competency will be unable to work in the IV compounding room until competence is certified and will be placed on a performance improvement plan. The employee will be retrained and re-evaluated to assure correction of all aseptic technique deficiencies. The employee will repeat the competency testing in 6 months. e. Records will be kept in the pharmacy for 3 years beyond the period of employment.

11. Annual Review of Sterile Compounding Policies by Pharmacist-in-Charge a. The policies and procedures manual shall be reviewed and such review shall be documented on an annual basis by the pharmacist-in-charge. Documentation will include the date of review and the signature of the pharmacist-in-charge. b. 2.The policies and procedures shall be updated whenever changes in policies and procedures processes are implemented.

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274/288 12. Nursing Personnel Orientation and Education: a. Pharmacy will provide all nursing supervisors with orientation to the IV admixture service. b. Pharmacy will conduct annual competency evaluations of all nursing supervisors to evaluate skills on preparing and dispensing intravenous medications. c. In-service training will be presented to the nursing supervisors regarding IV admixture problems encountered from medication errors or other quality improvement activities. d. Records of orientation, training, education, and competency evaluations shall be maintained in the pharmacy.

13. Quality Assurance: See policy Compounding 1735 and 1751 Compliance.

14. Reconciliation of IV Admixtures: a. A 24-hour supply of IV admixtures will be prepared (if feasible) for each patient. Each working day, Pharmacy will reconcile solutions needed, locations of patient, discontinued orders, schedules of administration, new rates, order changes, etc in order to increase efficiency and decrease wastage.

REFERENCES 1. Division 17 of Title 16 CCR §1735 - January 2017

2. Division 17 of Title 16 CCR §1751- January 2017

3. Business and Professions Code: Sections 4005, 4036, 4037, 4051, 4052, and 4127

4. United States Pharmacopeia (USP) – Chapter 797- 2008

APPROVALS

System Alameda AHS/Highland/John George/San Leandro Department Date: N/A 07/2020 07/2020 Pharmacy and Date: 07/2020 N/A N/A Therapeutics (P&T) Clinical Practice Date: 08/2020 N/A N/A Council (CPC) Medical Executive Date: N/A N/A 08/2020 Committee Board of Trustees Date: N/A N/A

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275/288 Separator Page

Medication Compounding 1735 Compliance SLH

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MEDICATION COMPOUNDING (SLH)

Department Pharmacy Effective Date 09/2012 Campus San Leandro Hospital Date Revised 11/2012, 2/2016, 10/2017, 07/2018, 09/2018, 04/2019, 07/2020 Category Clinical Next Scheduled Review 09/2023 Document Owner Director of Pharmacy; Executive Responsible Chief Administrative Manager, Medication Officer/Chief Nurse Executive Safety Printed copies are for reference only. Please refer to electronic copy for the latest version.

PURPOSE To provide standardized guidelines for complying with section 1735 and 1751.

POLICY SLH Pharmacy will be in compliance with the requirements established by the Board of Pharmacy.

DEFINITIONS 1. Section 1735 and Section 1751 defines compounding, scope, and specific requirements applicable to the compounding process, effective 7/6/10 and revision take effect January 1, 2017.

2. Additional parameters and requirements are applicable solely to sterile injectable compounding included with Board of Pharmacy (BOP) California Code of regulations (CCR) Division 17, Title 16, Article 7 - Section 1751.

3. “Integrity” means retention of potency until the expiration date noted on the label.

4. “Potency” means active ingredient strength within +/- 10% of the labeled amount.

5. “Quality” means the absence of harmful levels of contaminants, including filth, putrid, or decomposed substances, and absence of active ingredients other than those noted on the label.

6. “Strength” means amount of active ingredient per unit of a compounded drug product.

7. “Compounding” means any of the following activities occurring in a licensed pharmacy, by or under the supervision of a licensed pharmacist, pursuant to a prescription or chart order: a. Altering the dosage form or delivery system of a drug

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277/288 b. Altering the strength of a drug c. Combining components or active ingredients d. Preparing a drug product from chemicals or bulk drug substances

8. Compounding does not include reconstitution of a drug pursuant to a manufacturer’s direction(s) for oral, rectal, topical, or injectable administration, nor does it include tablet splitting or the addition of flavoring agent(s) to enhance palatability. It also does not include IV premixes, Mini Bag Plus, or Add Vials.

PROCEDURE General Guidelines 1. The Pharmacist in Charge or designee shall identify those products they prepare that meet the definition of compounding.

2. Examples of products that meet the definition of compounding are included but not limited to: Total parenteral nutrition, additional electrolytes added to intravenous fluids, antibiotics without the use of Mini Bag Plus, preparation of stock solutions, etc.

3. The pharmacist performing or supervising compounding has responsibility for the integrity, potency, quality and strength of the compounded product until it is dispensed.

4. The Pharmacist shall have a valid prescription or chart order prior to compounding a patient specific product, unless to ensure continuity of care for the patient a product is compounded in reasonable anticipation of receiving a prescription or chart order for the compounded product. Products made in anticipation of a prescription or chart order shall be documented on a “Batch Log” or similar document which shall delineate those specific elements of the products within the Inpatient Pharmacy.

5. The pharmacist performing or supervising compounding is responsible for the proper preparation, labeling, storage, and delivery of the compounded drug product.

6. Any changes in the process of compounding or any adjustments to policy and procedure will be communicated to the pharmacy staff via staff meetings, email, or training.

7. Beyond use dating of sterile compounded products: See policy Intravenous Admixture Service.

8. For out-sourced compounded products, the pharmacist shall only order from the approved vendors. a. Only the compounding pharmacy vendors on the approved list are authorized to conduct business with San Leandro Hospital (current approved vendor: CAPS pharmacy and QuVa) b. Any outsourced compounding products shall be documented.

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278/288 Master Formula Record 1. A drug product shall not be compounded until the pharmacy has first prepared a written master formula record that includes at least the following elements: a. Active ingredients to be used. b. Inactive ingredients to be used. c. Equipment to be used. d. Specific and essential compounding steps used to prepare the drug. e. Quality reviews required at each step in preparation of the drug. f. Post-compounding process or procedures required, if any. g. The maximum allowable beyond use date for the preparation, and the rationale or reference source justifying its determination h. Instructions for storage and handling of the compounded drug preparation.

2. Master Formula Record Sheets are kept in the Pharmacy. a. For compounding products not on formulary, the pharmacist shall contact the prescriber to recommend an alternative from the Compounding Formulary Alternative List, if one is available. b. The standardized Master Formula Production Record and Worksheet shall be used to record the preparation of sterile compounded products not included in the Compounding Formulary database.

Records of Compounded Drug Products 1. For each compounded drug product, the pharmacy records shall be documented in Pharmacy computer system and a written Compounding Log will be completed, including the following elements: a. A reference to the master formula record (linked by drug name or ingredient names, etc) b. The date the drug product was compounded c. The identity of the pharmacy personnel who compounded the drug product d. The identity of the pharmacist reviewing the final drug product e. The quantity of each component used in compounding the drug product f. The manufacturer and lot number of each component. If the manufacturer name is demonstrably unavailable, the name of the supplier may be substituted. g. A pharmacy assigned reference number such as a system generated prescription or order number. For batch prepared products, the lot number shall also be documented. h. The expiration beyond use date or beyond use date and time of the final compounded drug product preparation, expressed in the compounding document in a standard date and time format. i. The final quantity or amount of drug product compounded j. Documentation of quality reviews and required post-compounding process and procedures.

2. Storage of the compounded drug records will be kept on-site in a readily retrievable form for at least three years from the date the record was created.

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279/288 Labeling of Compounded Drug Products 1. In addition to the labeling information required under Business and Professions Code section 4076, the label of a compounded drug product shall contain the brand or generic name(s) of the principal active ingredient(s).

Compounding Facilities and Equipment 1. Compounded sterile products are prepared in a compounding aseptic isolator. See policies Intravenous Admixture Service and Use of the Germfree Compounding Aseptic Isolator (CAI or Glovebox).

2. The compounding aseptic isolator shall be certified every 6 months by a qualified certification company, Technical Safety Services, 510-845-5591. Certification records must be retained for at least 3 years.

3. Viable air and surface sampling a. Viable surface and air sampling shall be done at least every six months for all sterile to sterile compounding, by a qualified certification company. Currently at San Leandro, we are using Technical Safety Services, 510-845-5591. b. Viable air sampling shall be done by volumetric air sampling procedures which test a sufficient volume of air (400 to 1,000 liters) at SLH IV sterile compounding room and shall be done at least once every six months. c. Viable air and surface sampling are to be performed under dynamic conditions that simulate actual production. d. Viable air and surface sampling result CFUs can not exceed USP thresholds of following per USP<797>

e. When the environmental monitoring action shows growth: i. CFUs will be identified to at least the genus level ii. The glovebox and compounding aseptic isolator will be cleaned immediately, before patient care activities resume iii. The pharmacist-in-charge or a designated pharmacist will investigate and assess if additional action is needed. iv. The actions taken will be documented with the documentation of the results of the test. 4. Non Viable particle counts sampling a. ISO-5 CAI: perform every six months as part of hood re-certification for low and medium risks Particle counts sampled approximately 6-12 inches upstream of the critical exposure site shall maintain ISO Class 5 levels during compounding operations. Not more than 3520 particles (0.5 um and larger) per cubic meter shall be counted during material transfer, with the particle counter probe located as near to the transfer door as possible without obstructing transfer.

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280/288 b. Segregated compounding room: perform every six months c. ISO Class 5: Not more than 3520 particles 0.5 µm and larger size per cubic meter of air for any PEC (LAFW, BSC, CAI, and CACI) d. ISO Class 7 (segregated compounding room: Not more than 352,000 particles of 0.5 µm and larger per cubic meter of air for any buffer area

5. The pharmacy shall be arranged in accordance with Section 490A.3 of Title 24, Part 2, and Chapter 4A of the California Code of Regulations. Items related to the compounding of sterile injectable products within the compounding area shall be stored in such a way as to maintain the integrity of an aseptic environment.

6. Refrigerators: See policy Medication Refrigerator/Warmer Monitoring.

7. Freezers a. The Pharmacy freezer temperature shall be maintained between -20 degrees C and -50 degrees C; the temperature log shall be completed each day, changed monthly, and retained.

8. Balances and Weights a. Balances and weights shall be handled according to good pharmaceutical technique and kept clean at all times. b. Alameda County Bureau of Weights and Measures shall certify balance and weight every two years, or may be called in the interim period.

9. Glassware a. Glassware required by the California State Board of Pharmacy must be maintained at all times (California State Board of Pharmacy, Section 1711). b. All glassware must be cleaned with appropriate solvent immediately after use.

Training of Compounding Staff 1. The pharmacy shall develop and maintain initial and annual competency training and evaluation process for pharmacy personnel involved in compounding, and shall maintain documentation of any and all training related to compounding undertaken by pharmacy personnel which demonstrates that pharmacy personnel have the knowledge, skills and training required to properly and accurately perform their assigned responsibilities relating to compounding. Refer to policy Intravenous Admixture Service.

Quality Assurance 1. Quality Assurance shall include documentation of the methodology used to test integrity, potency, quality, and labeled strength of compounded drug products.

2. The Pharmacist in Charge or designee will conduct a documented, ongoing quality assurance program that monitors personnel performance, equipment and facilities. Quality Assurance shall include at least the following: a. Each individual involved in the preparation of sterile injectable products must successfully complete a validation process on technique before being allowed to prepare

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281/288 sterile injectable products. See policy Intravenous Admixture Service. b. Cleaning and sanitization of the parenteral medication preparation area shall be documented. c. Ensure proper storage of compounded sterile injectable products in the pharmacy and documentation of refrigerator temperatures. d. Steps to be taken in the event of a drug recall. Based upon California Business and Professional Code Section No. 4127.9(a): A pharmacy licensed pursuant to Section 4127.1 or 4127.2 that issues a recall notice regarding a sterile compounded drug shall, in addition to any other duties, contact the recipient pharmacy, prescriber, or patient of the recalled drug and the board as soon as possible within 12 hours of the recall notice if both of the following apply: (1) Use of or exposure to the recalled drug may cause serious adverse health consequences or death. (2) The recalled drug was dispensed, or is intended for use, in this state For more detail San Leandro Hospital Recall policy, please refer to Medication – Drug Recalls. e. Written justification of the chosen expiration dates for compounded sterile injectable products. Refer to policy Intravenous Admixture Service. f. End product testing shall include:  Action in the event any compounded drug preparation outside minimum standards for integrity, potency, quality or labeled strength o •The pharmacy staff involved in the preparation of the product is immediately removed from compounding any further products until they complete another media fill test demonstrating no CFUs documented. o •The hospital Infection Control specialist is notified to ascertain any concerns/actions recommended

End product testing 1. Sterility a. CSPs will be tested for sterility at least quarterly by Dynalab. b. Samples will be taken from CSPs which were prepared for patients but not administered, if available. Medium risk products, as defined by USP 797, will be sampled if available. Otherwise, samples will be chosen randomly with regard to the staff member who prepared them. c. Test results i. Test results will be reviewed by the pharmacist-in-charge or a designated pharmacist. The review will be documented with the test result documentation. ii. If the compounded sterile product is found to have growth: 1. The staff member who prepared the product will be retrained on aseptic technique and repeat the competency test. 2. The staff member who prepared the product will not prepare sterile admixtures until passing the competency. 3. The outcome of the investigation and action taken will be documented with the test result.

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282/288 1. Potency a. CSPs will be tested for potency, Endotoxin and sterility testing at least quarterly by Dynalabs, 888-396-2522. b. Samples will be prepared on randomly chosen days by a staff member who is assigned to sterile compounding at that time. Medium risk CSP samples will send for potency and endotoxin testing at least quarterly (SLH pharmacy do not perform High Risk CSP) c. Test results i. Test results will be reviewed by the pharmacist-in-charge or a designated pharmacist. The review will be documented with the test result documentation. ii. If the compounded sterile product is found to be outside of the range of ±10% of the labeled strength: 1. The pharmacist-in-charge or designated pharmacist will investigate. 2. If appropriate, the staff member who prepared the tested product will be retrained. 3. The pharmacist-in-charge or designated pharmacist will determine if additional action is needed. 4. The outcome of the investigation and action taken will be documented with the test result.

REFERENCES 1. Division 17 of Title 16 CCR §1735 –January 2017

2. Division 17 of Title 16 CCR §1751 – January 2017

3. Business and Professions Code: Sections 4005, 4036, 4037, 4051, 4052, and 4127

APPROVALS

System Alameda AHS/Highland/John George/San Leandro Department Date: N/A 07/2020 07/2020 Pharmacy and Date: 07/2020 N/A N/A Therapeutics (P&T) Clinical Practice Date: 08/2020 N/A N/A Council (CPC) Medical Executive Date: N/A N/A 08/2020 Committee Board of Trustees Date: N/A N/A

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5 Alameda COMBINED

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Primary Stroke Center Performance Improvement Plan CY 2020

The Primary Stroke Center Performance Improvement Plan provides framework to the systematic approach of improving care for stroke patients at Alameda Hospital. The Stroke Program has an organized comprehensive approach to measure stroke patient care clinical indicators, analyze its performance and identify opportunities for performance improvement. The Primary Stroke Center Program delivers care to acute stroke patients based on the Brain Attack Coalition’s recommendations, clinical practice guidelines published by the American Heart Association and American Stroke Association (AHA/ASA) and other current evidence-based practice guidelines. The program participates in the AHA/ASA Get With The Guidelines (GWTG) for Stroke registry to collect and analyze data. Program performance improvement and measurement is focused on the TJC Stroke Performance Measures, the facilitation of clinical care, and patient satisfaction.

Measurement Strategy Quality improvement activities emerge from a systematic and organized framework for improvement. This framework, adopted by the hospital leadership, is understood, accepted and utilized throughout the organization, as a result of continuous education and involvement of staff at all levels in performance improvement. Quality improvement involves two primary activities:  Measuring and assessing the performance of the Stroke Program through collection and analysis of data. Strategies used to accomplish improved quality of the Stroke Program are real time monitoring, concurrent chart review and retrospective chart audit.  Conducting quality improvement initiatives and acting where indicated through the design of new processes or improvement of existing processes and services. The formal adopted approach to performance improvement is Plan-Do- Study-Act (PDSA).

Stroke Program Committee

The following are members of the Stroke Steering Committee: Neurologist MD, Stroke Director; MD Medical Director of Emergency Care Center; RN, VP of Patient Services; RN, Stroke Coordinator; RN, Director of Emergency Care Center; RN, Nurse Manager of Inpatient Services; RN, Clinical Education Specialist; Director of Laboratory; Director of Radiology; Director of Rehabilitation; and Director of Respiratory Care Services.

The Stroke Program Committee is a multidisciplinary committee led by the Stroke Program Coordinator and Stroke Program Medical Director. Membership consists of representatives from Emergency Department, Hospitalist, Nursing, Radiology, Laboratory, Rehabilitation Services, Respiratory Care, Pharmacy, Clinical Education, and Quality.

The Stroke Program Committee closely monitors performance on identified metrics and actively address areas needing improvement with operational leaders. The Stroke Program Coordinator shares data and identified trends during Committee meetings for analysis and

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Primary Stroke Center Performance Improvement Plan CY 2020 discussion of interventions.

The Stroke Program reports on a regular basis to the Quality and Safety Committee (QSC) which has oversight of quality and performance improvement activities for the hospital. The QSC Chair reports information to the Medical Executive Committee (MEC) which then is reported to the Board of Trustees by the Chief of Staff.

Performance Metrics

The performance metrics for the Stroke Program include the following TJC Standardized Performance Measures for Primary Stroke Centers and CMS Outpatient Stroke Measure:

CSTK-1: The National Institute of Health Stroke Scale (NIHSS) will be performed with in 12 hours of arrival.

STK-1: Eligible stroke patients will receive venous thromboembolism prophylaxis (VTE) or have documentation why no VTE was given on the day of or the day after hospital admission.

STK-2: Eligible ischemic stroke patients will be prescribed Antithrombotic therapy at discharge.

STK-3: Eligible ischemic stroke patients with atrial fibrillation or atrial flutter will be prescribed anticoagulant therapy at discharge.

STK-4: Improve initiation times for intravenous recombinant tissue plasminogen activator (Alteplase) administration for eligible patients who arrive within two hours of symptom onset and are treated within three hours.

STK-5: Eligible ischemic stroke patients will be administered antithrombotic therapy by end of day two.

STK-6: Eligible stroke patients will be prescribed a statin at discharge or for those who were on lipid lowering medicine prior to hospital arrival.

STK-8: Eligible stroke patients will have documentation that they or their caregivers were given educational material addressing all the following:  Definition of stroke  Activation of the emergency medical system  Follow-up after discharge  Medications prescribed at discharge  Individualized risk factors for stroke  Warning signs and symptoms of stroke

STK-10: Eligible stroke patients will be assessed for or receive rehabilitation services.

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Primary Stroke Center Performance Improvement Plan CY 2020 STK-OP 1: Door to Transfer to another hospital:

 Hemorrhagic Stroke  Ischemic Stroke; Drip and ship  Ischemic Stroke; No IV Alteplase prior to transfer, large vessel occlusion (LVO) and mechanical endovascular retrieval (MER) eligible  Ischemic Stroke no IV Alteplase prior to transfer, LVO and not MER eligible  Ischemic Stroke no IV Alteplase prior to transfer, no LVO

OP-23: Stroke patients will have their head CT or MRI interpretation within 45 minutes of arrival.

Program specific internal benchmarks include:

1. Door to Head CT and CT Angiogram interpretation times will be monitored with a goal of 35 minutes or less.

2. Lab turnaround times goal is 35 minutes or less from patient time for the initial stroke panel.

3. CT completion time is 20 minutes or less for code stroke patients upon arrival to the Emergency Care Center by monitoring arrival time to head CT completion time for Code Stroke patients.

4. Improve door to drug time with the goal of 45 minutes or less for ischemic stroke patients who are eligible for Alteplase.

5. Monitor the patient/participant satisfaction and perception of quality of care by telephone and or mail survey.

6. Newly hired RNs are qualified and competent.

Monitoring and Analysis

Performance on various metrics are monitored and evaluated to determine whether there is an undesirable degree of variation or a failure to perform at the expected level. Problem areas area analyzed and opportunities for improvement are identified. An assessment of contributing factors and other variables are addressed using the PDSA methodology. Interventions may include an assessment of the current process and whether a process change needs to be introduced as well as individual staff follow up.

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Primary Stroke Center Performance Improvement Plan CY 2020 APPROVALS

System Alameda AHS/Highland/John George/San Leandro Department Date: N/A 03/2020 03/2020 Pharmacy and Date: N/A N/A N/A Therapeutics (P&T) Clinical Practice Date: N/A 05/2020 N/A Council (CPC) Medical Executive Date: N/A 05/2020 N/A Committee (MEC) Board of Trustees Date: N/A N/A

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September 24, 2020

TO: Quality Professional Services Committee

FROM: Brandon Boesch, D.O., Alameda Health System Chief of Staff Committee

SUBJECT: Agenda Item: B3

Meeting Date: September 24, 2020

Item Description: Medical Staff Physician Office Policy and Procedure

COMMITTEE ACTION: Approval of Medical Staff Physician Office Policy

Background: The Medical Staff Physician Practice Office policy provides the process and requirements for Office Based Medical Staff to maintain current office addresses as part of the requirements for membership and privileges as part of the Alameda Health System Medical Staff.

Analysis: This new policy includes a process for the Department Chair to review and confirm that the home office provided meets the standards to protect patient care and safety.

Prior Board Action: n/a

Board Action Requested:  Approval of the new Physician Practice Office Policy

Fiscal Impact: n/a

Budgeted/Authorized: n/a

Estimated Cost Savings: n/a

Strategic Plan Pillar: n/a Page 1 of 2

Alameda Health System

MEDICAL STAFF PHYSICIAN PRACTICE OFFICE POLICY

Department Medical Staff Effective Date 8/2020 Campus AHS Date Revised Unit All Next Scheduled Review 8/2023 Manual Medical Staff Author Director, Medical Staff Services Replaces the following Policies: Responsible Person Chief of Staff Printed copies are for reference only. Please refer to electronic copy for the latest version.

Purpose

To establish mechanism and define the process for maintaining current office address with the Medical Staff Office as part of the requirements for membership and privileges as a member of the Alameda Health System (AHS) Medical Staff.

Policy

It is the policy of the AHS Medical Staff to require current office addresses bey on file with the Medical Staff Office. To protect patient care and safety, Practitioners (as defined below) physicians must have an office address where they can see patients to provide services as routinely provided for patients post-discharge and or post-referral from ambulatory care.

Procedure

1. Medical Staff members with clinical privileges, not including members with “assist only” privileges or only telemedicine privileges. Physicians (as used herein, “Practitioners”) must timely notify the Medical Staff office of their office address where they see patients and can receive notices from the Medical .Staff. If a Practitioner physician fails to provide within ten (10) days after notice from the Medical Staff an office address that includes facilities, equipment and patient services of a medical office where the Practitioner physician has made arrangements to see his/her patients who are discharged from the hospital or referred from the hospital’s ambulatory care, the Practitioner’s physician privileges will be automatically suspended pursuant to Medical Staff Bylaws Section 7.3-8 pending receipt of such information, with an automatic resignation pursuant to Section 7.3-13 if the automatic suspension remains in effect for sixty (60) days.

2. If the Practitioner physician has a home office that includes facilities, equipment and staff to provide the same facilities, equipment, staff and patient services as customarily provided in an office, the Practitioner physician may provide information and documentation that confirms this for the Practitioner’s Department Chair to review and confirm the home office meets the standards described in this paragraph to protect patient care and safety. .

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3. Upon receipt of the update address, Medical Staff Services will update the office address which interfaces into the health systems electronic health record to provide continuity of patient care.

4. Members with “assist only” privileges or only telemedicine privileges must provide an address where they can receive notices from the Medical Staff within the time frames and be subject to the same automatic administrative actions for not timely responding as described in Section 1 above. However, members with “assist only” privileges are not required to have an office as described in Sections 2 or 3 above.

3.5. Members with clinical privileges will notify the Medical Staff Office of a change in office address within thirty (30) days following such change in address.

Approvals

Departmental Date: Medical Executive Committee Date: Board of Trustees Date: