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FINAL 10072010; 03012011

AOPO STANDARDS AND INTERPRETIVE GUIDELINES MARCH 2011

STANDARD INTERPRETIVE GUIDELINES

ADMINISTRATION STANDARD

AS 1 GOVERNING OR ADVISORY BODY

An organized governing and advisory The surveying team should determine that the OPO has a governing board must be established. and advisory board.

AS 1.1 The OPO will adopt written bylaws, Review the bylaws, operating rules or administrative policies and operating rules or administrative procedures. If separate bylaws, operating rules or administrative policies and procedures for the policies and procedures are not in place, the single bylaws should governing board and advisory board. define the roles of each Board to include at a minimum their responsibility, oversight, and compensation. Assure there are procedures to address potential conflicts of interest. Note the CMS Regulation (Standard 486.324; IG Z234) which states “Members of the advisory board are prohibited from serving on any other OPO board.” AS 1.2 The bylaws and operating rules (or Find the requirements for the standard in the bylaws or operating rules administrative policies and procedures of the OPO. for a HOPO) specify at least the following: AS The role and purpose of the 1.2.1 organization or mission statement. AS The duties and responsibilities of the The Governing Board must have full legal authority and responsibility 1.2.2 governing or advisory body. for the management and provision of all OPO services and develop and oversee implementation of policies and procedures including: fiscal operation, the OPOs quality assessment and performance improvement program (QAPI) and services furnished under contract or arrangement, including agreements for these services. The Governing

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STANDARD INTERPRETIVE GUIDELINES

Board appoints an individual to be responsible for the day to day operation of the OPO.

The Advisory Board has the authority to recommend policies for the following: procurement of organs, effective agreements to identify potential organ donors with a substantial majority of hospitals in its service area that have facilities for organ donation, systematic efforts including professional education, to acquire all usable organs from potential donors, arrangements for the acquisition and preservation of donated organs and provision of quality standards for the acquisition of organs that are consistent with the standards of the OPTN, appropriate tissue typing of organs, a system for the allocation of that is consistent with the rules and requirements of the OPTN, transportation of organs, coordination of activities with transplant hospitals, participation in the OPTN, arrangements to cooperate with tissue banks, annual evaluation of the effectiveness of the OPO and assistance to hospitals in establishing and implementing protocols for making routine inquiries about organ donations from potential donors. The Advisory Board has no authority over any other activity of the OPO. AS The mechanism for selecting and Review the Bylaws to determine the mechanism for selecting and 1.2.3 removing members, including the removing members, and that length of terms, attendance, frequency of length of terms. meetings are defined. There should be no overlapping of representation between Boards. Assure that all mandated categories are represented on the Advisory Board. Mandated representation includes: hospital administrators, either intensive care or emergency room personnel, tissue banks, member of a voluntary health association, a member of the public, a

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STANDARD INTERPRETIVE GUIDELINES

physician or someone with a doctorate degree in histocompatibility, a neurosurgeon or other physician with knowledge or skills in the neurosciences, a transplant surgeon representing each transplant hospital and an organ donor family member. AS The composition and responsibilities of Assess the committee structure, including the Finance or Audit 1.2.4 committees of the Governing and Committee, and determine responsibilities. Advisory Boards. AS The mechanism for review and revision Review bylaws to ensure the mechanism is defined. 1.2.5 of the bylaws or operating rules. AS 1.3 A record of current and ongoing Review the meeting minutes of the Governing and Advisory Board and proceedings of the governing and all Board committees. Both boards must meet at least annually unless advisory board and functioning otherwise specified by state law or the OPO bylaws. committees is maintained. AS 1.4 The governing or advisory body Find information in the meeting minutes of the governing board or approves by documentation an annual advisory body. operating budget (see AS.5 – Financial Policies and Procedures) AS 2 ORGANIZATION The organ An overall review of management practices will be necessary. procurement organization will be administered effectively and efficiently.

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AS 2.1 There shall be a chief executive officer Review the job description of the CEO/COO or equivalent responsible or equivalent responsible to a Board of to the Board of Directors or hospital administrator. Directors or appropriate hospital administrator for the day-to-day Job description should outline the authority that is granted to this operation of the OPO. individual regarding the daily operation of the OPO; implementation of policies established by the OPO Governing or Advisory body; a The CEO/COO implements the policies mechanism to ensure compliance with documentation regarding the established or recommended by the guidelines, laws and regulations set forth locally, statewide and governing body (or advisory body or federally. Review job description to determine responsibility for supervisory administrator for HOPO). development and implementation of personnel policies and financial management of the organization. HOPOs need to provide personnel The CEO/COO ensures and and financial management policies of hospital corporations. documents that the organization is in compliance with applicable local, state and federal guidelines, laws and regulations.

Position descriptions indicate the CEO/COO is responsible for the development and implementation of personnel policies and the financial management of the organization. The CEO/COO of a HOPO is responsible for adherence to the parent hospital personnel and financial management policies.

AS 2.2 A physician or medical director shall be a part of the organizational structure, and the following criteria shall be met: AS There is a formal job description that

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2.2.1 documents the relationship between the OPO and the physician/medical director. AS A written policy exists that addresses 2.2.2 potential conflicts of interest for the Medical Director. AS The Medical Director is a physician 2.2.3 licensed in at least one of the States or Territories within the OPO’s DSA. AS The Medical Director is responsible for 2.2.4 implementation of the OPO’s protocols for donor evaluation and management and organ recovery and placement. AS The Medical Director is responsible for 2.2.5 the oversight of the clinical management of potential donors, including providing assistance in managing a donor case when the surgeon on call is unavailable. AS 2.3 There shall be administrative staff or Assure that the administrative staff (clerical, data, business) are arrangements to ensure compliance employed by the OPO to ensure compliance with sound business with sound business practices and practices and procedures. Job descriptions should be reviewed. If procedures. there are associations with OPO management groups, the surveyor should review all contractual agreements. AS 2.4 The OPO shall have an organizational The surveyor should review the organizational chart and structure of structure that provides for proper the OPO/HOPO. operation of the OPO. AS 3.0 PERSONNEL POLICIES AND The surveyor should review personnel policies and procedures that are PROCEDURES in place within the OPO. Specifically, these policies and procedures The OPO shall have personnel policies should be reviewed to ensure that the OPO has adequate personnel in

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and procedures in place that provide place to support the mission and objective of the OPO. Additionally, guidance to the OPO employees and the OPO should have a policy and procedure manual. satisfy legal requirements. AS 3.1 Personnel policies and procedures The surveyor should review personnel policies and procedures that are should be in a collective format, i.e., in place within the OPO. These may be incorporated into the personnel policies and procedures Employee Handbook. manual. AS 3.2 Personnel policies and procedures will The surveyor shall determine how accessible the manuals are to all be documented, available and employees. accessible to all personnel. AS 3.3 Personnel Policies and Procedures will Ascertain the process that addresses changes in policies and provide for how changes and additional procedures and how they are communicated to OPO personnel. are communicated to all personnel. Survey staff as to how process works. AS 3.4 Personnel Policies shall contain the following information: AS A statement and/or policy and The policy and procedure manual should be verified to show 3.4.1 procedure defining the compliance with compliance with local, state and federal regulations regarding EEOC, local, state and federal regulations for ADA, nondiscriminatory employment practices, minimum wage employees. Examples may include information, COBRA information and universal precautions. (depending on the number of employees and other factors): Civil Rights Act, Fair Labor Standards Act, Americans with Disabilities Act, COBRA. AS Hiring and Termination 3.4.2 AS The hiring process shall be defined Hiring and termination procedures must be defined. Specifically, 3.4.2.1 and may include definitions of processes which may include probationary or training periods. probation/training periods. AS The termination process shall be Determine process through interview if no specific policy.

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3.4.2.2 defined. AS Wage, Salary and Benefits Program to Personnel Policy Manual and/or Employee Handbook or other 3.4.3 include: appropriate OPO policy must contain information regarding wages, salary and benefit programs. AS Definition of employees as exempt or 3.4.3.1 non-exempt AS Non-exempt wage and benefits 3.4.3.2 program AS Exempt salary and benefits program 3.4.3.3 AS Corporation’s paid holidays and Corporation’s paid holidays and additional benefits, (i.e., personal time, 3.4.3.4 additional benefits, e.g., personal time, paid leave) should be documented. paid leave. AS Additional items such as automobiles, Review for policy for each item, as applicable. 3.4.3.5 automobile allowances, mileage expenses, cellular telephones, etc. AS Definition of reimbursable travel and Review definition of reimbursable travel and education expenses 3.4.3.6 education expenses. AS Definition and process for Review definition and process for reimbursement of business expense. 3.4.3.7 reimbursement of business expense. AS Definition and process for pay Review description of the process involved for overtime, compensatory 3.4.3.8 practices such as overtime and time and on-call time. compensatory time. AS Definition of other forms of Review definition of other forms of compensation, if appropriate, (i.e., 3.4.3.9 compensation, if appropriate, e.g., on- on-call pay and bonus programs) and documentation of payment. call pay and bonus programs. AS 3.5 Job Expectations, Performance The surveyor should review job descriptions for each position within Review and Development the OPO, paying attention to overall job summary, reporting structure and minimum job requirements. Additionally, the surveyor should assure that a job description is reviewed and documented with each

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employee prior to, or at the time of employment. The OPO should have an established Code of Conduct describing what professional behavior is. An example is the AOPO Code of Conduct, developed by the Medical Directors’ Council. AS A formal job description is documented Review all job descriptions to ensure that every job position has a job 3.5.1 and available for each job category description. Match job descriptions to organizational chart. and shall include: AS Overall job summary Synopsis of job should be included. 3.5.1.1 AS Reporting structure Reporting structure should be defined. 3.5.1.2 AS Minimum (and essential, if applicable) Minimum (and essential, if applicable) job requirements, such as 3.5.1.3 job requirements, such as education, education, training, certification, experience and responsibilities will be training, certification, experience and defined. responsibilities. AS At the time of employment, the At the time of employment, the employee’s job description will be 3.5.2 employee’s job description will be reviewed and documented with the employee. reviewed and documented with the employee. AS A formal performance review process The surveyor should review the performance review document for 3.5.3 is documented and defined. several levels of employees. The performance review should be conducted annually.

AS 4 COMPENSATION The OPO shall There must be a methodology within the personnel policy manual, have a defined plan for the employee handbook, and/or other appropriate OPO policy describing administration of employee the procedure for salary changes. compensation. Surveyor should review the OPO’s process for establishing salary levels for staff, management and physician administrators. The review should assess the methodology for salary structure (salary survey,

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hiring philosophy related to placement within salary range). The surveyor should assure that the salary ranges are based upon good judgment and sound business practice. AS 4.1 The OPO must provide evidence that Determine that a compensation philosophy and methodology exists to salary ranges have been established recruit/retain and provide internal/external equity for staff for its staff level employees that reflect compensation. Assess that salary grades and ranges have been the position’s requirements for level of established for staff level employees that reflect the requirements for experience and training and the scope level of experience, training and the scope of job responsibilities. of job responsibilities. AS 4.2 The OPO must provide evidence that Determine that a compensation philosophy and methodology exists to salary ranges have been established recruit/retain and provide internal/external equity for senior for the senior administrative staff that administrative staff compensation. Assess that salary grades and are based upon the individual’s level of ranges have been established for senior administrative staff that reflect training and experience and the scope the requirements for level of experience, training and the scope of job of the responsibilities of the position. responsibilities. AS 4.3 Full or part-time physician Full and part-time physician administrators’ compensation shall reflect administrators’ compensation. training, experience and organizational responsibilities. AS 5 FINANCIAL POLICIES AND PROCEDURES The OPO has policies and procedures  The purpose of the review of this section is to ensure that the in place that describe and document OPO has effective financial oversight in place and complies with the processes in place to ensure the existing laws and guidelines; ensuring that its fiscal and effective financial management and accounting procedures are consistent with this standard. financial oversight of the organization.  The surveyor should assure that the OPO has written financial These documented processes also policies and procedures in place in a manual or other organized ensure the OPO complies with current format available for review. and existing Federal laws and  HOPOs are required to follow accounting procedures guidelines, as well as the appropriate established by their parent corporation. The parent utilization of financial resources. corporation’s accounting procedures should be reviewed. (HOPOs may be obligated to follow the fiscal and accounting procedures

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established by the hospital’s governing directors and may, therefore, be exempt from specific procedures defined in this standard). AS 5.1 The OPO, or its parent organization, Surveyor should verify: will be a nonprofit entity under section 501(c)(3) of the IRS Code of 1986.  Existence of “IRS 501(c)(3) Letter”- classifies the OPO or its parent organization as a nonprofit entity under IRS section 501(c)(3)  The letter is current (i.e., the determination remains the same)  Letters are in existence for all related entities including foundations and other supporting organizations  All entities have Tax ID #’s assigned  Federal Form 990 has been filed timely for most recent fiscal year and is available for review AS 5.2 The OPO will maintain certification The surveyor should verify the following: from the Federal government to be  The OPO is currently CMS certified by reviewing current CMS reimbursed under CMS for the costs OPO designation letter attributable to procurement of covered  Obtain documentation of the OPO’s Medicare provider number organs (42 CFR Part 485). A to assure compliance policy/procedure should be in place to  Review policy and procedure documentation and processes in ensure proper allocation of recovery place to ensure: costs for organs and/or tissues. o appropriate method of standard acquisition charge development o appropriate methods of cost allocation to renal and non- renal cost centers o Proper board or finance committee approval and/or involvement. (Also can review meeting minutes to verify statements in policies). AS 5.3 The OPO must provide evidence that a Review/verify the following:

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Cost Report is completed at least  The past three years cost reports have been filed. annually in compliance with approved  Obtain the most recently settled cost report- formats provided by the Medicare fiscal o Verify this through the existence of intermediary intermediary. documentation (usually a final adjustment report). o Examine the correspondence for any concerns noted by the intermediary, and determine if all questions were adequately answered or appropriately handled. o Review the adjustment report for any material adjustments or issues and follow up on how the OPO responded.  Review documentation on status of any re-opened cost reports or cost reports under appeal AS 5.4 The OPO shall have established A review of financial policy and procedure should be undertaken to procedures for obtaining payment for verify- procurement services; and effective  OPO has policies and procedures in place for billing and cash management should be in obtaining timely payment for kidneys and non-renal organs evidence to ensure the OPO’s fiscal provided to transplant centers stability.  An accounts receivable aging report should be available verifying outstanding A/R over 90 days is reasonable. Less than 10% (or less than 25% over 60 days) is a general guideline. Any issues should be investigated by reviewer.  The working capital ratio (current assets divided by current liabilities) should be determined for reasonableness. It is a measure of an organization’s cash flow and ability to satisfy its short-term obligations. A guideline of 2 to 1 (current assets twice current liabilities) is generally appropriate.  Appropriate accruals for any Medicare receivables or payables should be reflected within the financial statements  OPO has an investment policy in place and the investments held by the OPO comply with this policy

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AS 5.5 There shall be an annual budget Review the financial policies prior to the site visit to ensure the approved by the governing or advisory following processes are addressed and are in place: body. The OPO must maintain a  Budget development process, timelines, and finance committee documented set of financial policies and board approval process. Verify processes are followed and procedures, and must maintain a through meeting minutes. system for reporting of financial  Interim financial reporting- operating results to the governing body o Processes are addressed and followed as documented in at least annually. policy. Ask for and review most recently presented interim financial statements (verify through board/finance meeting minutes) o Determine frequency of reporting o Examine the timeliness of financial reports (generally most OPOs have their reports available within 4-6 weeks after the close of the accounting period.) o Review board/finance meeting minutes for acknowledgment and/or approval of financial results/spending plans  OPO follows GAAP and accrual accounting (review method of general ledger posting process)  Processing of accounts receivable o Issuance of invoices and billings o Handling of checks and bank deposits  Approval and processing of accounts payable o Expenditure approval o Check signing authority  Payroll procedures  Bank account reconciliation process  Fixed asset or property and equipment accounting and control AS 6 FINANCIAL AUDIT Unless otherwise provided by law, Surveyor should verify:

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there will be an annual financial audit conducted by an independent public  Completion of current annual independent audit performed by accountant. In the case of HOPOs, the Certified Public Accountants. hospital must undergo an annual financial review related to OPO costs. 1. Required Communications Any issues identified by the financial 2. Report of Independent Auditors (“Opinion Letter”) audit or its resulting audit report will be 3. Audited Financial Statements (including “Notes to effectively addressed by the OPO. Financial Statements”) 4. Report on Internal Control (“Management Letter”)

 Required Communications: Statement of Auditing Standards No. 61 requires the auditor to ensure that the Board of Directors (or indirectly through the audit or finance committee) receives additional information regarding the scope and results of the audit that may assist the Board in overseeing management’s financial reporting and disclosure process. The surveyor should review the Required Communications Letter and determine if there are any: o Significant accounting policy changes o Significant audit differences or adjustments o Disagreements with management o Major issues discussed with management prior to retention o Consultation with other accountants o Serious difficulties encountered in performing the audit o Material errors, irregularities and illegal acts o Significant disclosures not made o Material weaknesses in internal controls o Independence issues Review the letter to determine if any of these areas presented

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by the auditors reflect negatively on management. If so, discuss with management and/or seek assistance and guidance from an appropriate financial resource.

 Independent Auditor’s Report (“Opinion Letter”): o Is on the letterhead of the audit firm and should indicate that the auditors are Certified Public Accountants.

o Includes the wording: “In our opinion, the financial statements referred to above present fairly, in all material respects, the financial position of in conformity with U.S. generally accepted accounting principles”. If this wording includes the phrase “except for,” then seek assistance and guidance in interpreting the statement from an appropriate financial resource. Is signed and dated by the audit firm.

 Management Letter: o A separate letter from the audit firm, usually addressed to the board of directors. o Includes observations regarding the auditor’s findings and recommendations for process and procedural improvements. It might indicate deficiencies, note concerns, make recommendations for compliance and/or change in practice, or give a “heads up” to the board on topics of operational or legal concern. o Examine the letter any noted deficiencies. Ask for management’s response to the letter, and determine whether the recommendations were implemented or the deficiencies corrected. If not, determine management’s

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reasoning.

 Change in Auditors: o Determine if there has been a change in audit firms either two years previously or since the current audit report. o If there has been a change, inquire as to management’s reasoning. Ask specifically if a difference of opinion caused the change; and if so, what the difference of opinion was. AS 7 DOCUMENTATION OF COSTS AND THE ESTABLISHMENT OF ACQUISITION CHARGES The OPO shall have policies and The surveyor should request a copy of the OPO’s most recent cost procedures established for the report for review of this section. HOPOs must adhere to the documentation of all direct and indirect appropriate hospital authority’s policies, established accounting costs. These costs shall be used as policies and procedures for this particular section. General guidance the basis for the establishment of for AS 7.1 – AS 7.5: In review of the section, the surveyor should organ and/or tissue acquisition specifically be looking for expense allocations as provided in charges. accordance with Medicare guidelines for and by the appropriate hospital authority. This should include a review of agreements with other agencies, companies, providers or vendors. The OPO’s records shall include documentation of allocations made to specific organ/tissue cost centers for direct expenses incurred by the organization for organ recovery. A review of a minimum of five donor hospital bills should be undertaken. Additionally, the accounting records must permit the expensing of indirect costs in compliance with Medicare rules and guidelines. The OPO’s statement as to the development of standard acquisition charges and the review of those charges shall be available. Review documentation that reflects at

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minimum annual review of SAC fees. In the case of HOPOs, the review of a SAC must be in accordance with a hospital governing policy. This policy must be reviewed. AS 7.1 The OPO shall establish accounting The surveyor should examine policy and procedures manual and policies and procedures to permit assure that practice and policy are consistent. allocation of all its direct and indirect costs to the organ and/or tissue cost Surveyor should review Worksheet A – Trial Balance of Expenses from centers maintained by the the most currently filed cost report to verify that direct and indirect organization. The policies and expenses are being broken down by organ for each line item. procedures shall be in compliance with Surveyor should review Worksheet A-4 – Reclassifications and the current approved Medicare cost Worksheet A-5 – Adjustments to Expenses and review supplemental report and all policies set forth by the schedules that tie into worksheet A-4 and A-5. current Medicare intermediary. HOPOs shall adhere to an appropriate hospital authority for established accounting policies and procedures. AS 7.2 The OPO’s accounting records shall be The surveyor should review the most recently closed cost report for maintained to permit allocation of costs any adjustments made by the intermediary. This would verify that in accordance with the appropriate changes have been implemented in subsequent cost reports or verify guidance provided by the Medicare that the OPO is currently undergoing an appeals process for the program (or by the appropriate hospital recommended intermediary adjustments. Surveyor should also review authority for HOPOs) and by the NPR and management letter, if any, from the intermediary for the established agreements with other most recently closed cost report year agencies, companies, providers or vendors. AS 7.3 The accounting records of the Records documenting the payment of a donor hospital bill shall identify organization shall include the organs procured and shall document the allocation of the costs to documentation of allocations made to each organ type. Review a minimum of five donor hospital bills and organ and/or tissue cost centers, as the accompanying donor charts to verify that expenses from the applicable. hospital bill are being allocated to that direct organ expense. Expenses directly related to a specific organ should be allocated only

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to that organ direct expense. For example, a cardiac catheterization would be expensed to heart direct expense, bilirubin would be expensed to liver direct expense, etc. Alternatively, an acceptable methodology is if the OPO divides total hospital bill by number of organs/tissues and makes the allocation. AS 7.4 The accounting records of the Assure indirect costs are allocated to specific organs and tissues as organization shall document the Medicare requires. expensing of indirect costs (e.g., office rent, utilities, administrative salaries Surveyor should review Worksheet A-1 – Administrative and General and salary related costs) so that they Expenses. may be allocated in compliance with Medicare rules and guidelines, to specific organ types, or to tissue recoveries. AS 7.5 The acquisition charges are to be To assure SACs are established by Board policy, look for such things established in accordance with the as: governing body/policy (or advisory board/policy for HOPOs), and in  Financial policy and procedures with Board approval compliance with prevailing Medicare  Board minutes program rules and regulations. The  Approval of the budget that includes the SAC OPO shall maintain the ability to  Finance committee minutes with SAC discussion noted develop and utilize average  Randomly select and review two donor cases and tie out procurement costs as a partial basis the revenue to those two donor cases for establishment of its organ acquisition charges. AS 8.0 DATA AND INFORMATION MANAGEMENT AS 8.1 The OPO will have a data Determine that the OPO has a data management system whether management system for donor electronic or paper-based that is in accordance with current regulatory information management and support standards. For example: can the OPO provide information to UNOS which provides information and as required? Does the OPO have a data management system for

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analytical capability for donor record each area mentioned in the standard? keeping, hospital development, finance, personnel, and other business areas affected by or important to donor information management, while maintaining security and confidentiality of data, and opportunity for transfer of data to other organizations or a successor. AS 8.2 The OPO shall have a data collection Ask to see samples of routine reports (whether computer generated or and documentation system(s) that hand produced) used by the manager of procurement, hospital provides management and users with development, personnel, and finance. timely, accurate information in an Interview management staff on their methods of data gathering, input, easily accessible and readable format. report generation, and analysis. Interview staff on their process to ensure the quality of data in the system? Ask staff to produce a sample report of data specified by the site surveyor; e.g., ask for a report of all donor referrals for the last month, or a list of all routine death notifications from XYZ hospital, or a sick- time utilization report, or an accounts receivable listing, etc. AS 8.3 Data storage, retrieval, and processing Interview data management staff and ask for a demonstration of how systems must be in a format that this standard might be accomplished. allows for transfer of information to other organizations, and which could be transported in their entirety to a successor OPO, if needed. AS 8.4 Donor Management Software Is there a maintenance agreement with the vendor that indicates how Maintenance and Support Agreements problems can be reported and fixed? for OPOs that have purchased a third Is there documentation that allows the OPO to upgrade to party Donor Management Solution versions/releases? Is there contract documentation that ensures that the OPO can retain

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ownership of the application and source code in the event that the vendor goes out of business? AS 8.5 Security: The OPO shall use reasonable efforts to ensure the security and confidentiality of its network. AS User Security Ask to see New User Setup Procedures and User Termination 8.5.1 Procedures User Audit: Is the list of users who have access to the network and key systems reviewed on a regular basis to make sure the list is accurate? Is an external/internal security audit performed at least every 18-24 months. What was the result of the audit; what did the OPO do with the information?

AS Password Security Does the OPO have a password policy: for example, strong 8.5.2 passwords should be encouraged (such as minimum length 7 characters using 3 of the 4 following criteria: uppercase letters, lowercase letters, numbers and/or symbols. Passwords should be changed every 90-120 days with limited reuse of passwords).

AS Virus & Spyware Protection Virus Protection: Are all servers, computers, e-mails scanned for 8.5.3 viruses? Are the virus definitions up-to-date? Spyware: Does the OPO have a procedure for handling spyware? Are efforts made to curtail SPAM in emails? AS Internet and Intranet Security Internet Use: Does the OPO have a policy regarding appropriate 8.5.4 internet use? Firewall: Is a firewall installed? Are security tools used on internal web servers: for example IIS, Eeye Shield, or Apache? Does the OPO have a policy regarding remote access/outside network connectivity? AS Physical Security Servers and Telephone Switches: Are servers in a locked area. 8.5.5 Old Computers: What has been done to prevent release of

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confidential information (i.e., destroyed, reformatted, etc.) AS Disaster Recovery: The OPO shall routinely backup its data and create a disaster recovery plan for computers 8.6.0 and telephones. AS Disaster Recovery Plan Does the OPO have a disaster recovery plan in place for computers 8.6.1 and telephones? AS Off-Site Relocation Does it include a plan for off-site relocation? Is the off-site relocation 8.6.2 determined relative to the intent of the disaster recovery plan? AS Data Backup Policy Does the OPO have a data backup policy? Is it being followed? Ask 8.6.3 the OPO to retrieve information from backup tapes; ask for date of last backup test and how test worked out. AS 8.7 Maintenance of Infrastructure: a plan and process to ensure that all mission critical software and hardware is supportable throughout the expected life of the product(s). AS IT Staff Support Is there a process or vendor/agency to fallback on in the event that the 8.7.1 current IT staff was unavailable? Who does staff (users) call/contact when vendor or designated IT staff is unavailable? Is critical information maintained and stored in a secure area? For example: Demonstrate the maintenance and storage of critical information such as server passwords that are locked in a secure area and available to senior management AS Hardware & Software Support Is there an inventory of PCs and their support plan and when they are 8.7.2 scheduled to be upgraded or replaced with new PCs? Are there server support agreements/warranties and plan/process to replace those servers? Is software kept up to date? AS 8.8 Infrastructure Documentation Is there documentation available that details the network infrastructure, i.e., domains, server names, policies & procedures for key activities. AS 8.9 User Support: The OPO shall provide Is there a designated person whether internal or external to provide user support to all staff. user support for critical operations? Does the OPO staff know how to obtain user support at any time (24/7)? AS Software Development: For those For OPOs who engage in internal software development. Does the 8.10 OPOs that engage in software OPO have a process in place that meets all the regulatory guidelines

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development, the OPO shall establish that apply to the use of the developed software. Does the OPO have a a process for determining software documented succession plan should critical personnel leave the needs, validation/ verification and organization (i.e. developers). succession plan. AS 9 OPO INSURANCE The independent OPO will maintain Review evidence that the OPO has insurance policies for professional current insurance policies for and business liability that takes into account such things as OPO size, professional liability and business service area and level of risk. Generally, a minimum level of $1 million practices (such as directors and is recommended. officers and employment related practices). The HOPO will maintain current insurance policies or documentation of appropriate coverage by the parent company for professional liability and business practices. AS 10 COOPERATION WITH TISSUE AND EYE BANKS The OPO shall have policies and The surveyor should review the documents to show the relationship practices in place for eye and tissue the OPO has with tissue and eye banks. Specifically, these referrals, as required by Medicare documents should include the mechanism in place to ensure that all Conditions of Participation. usable tissues are obtained from potential donors. The OPO shall have policies and practices in place for eye and tissue referrals, as The OPO must have arrangements to required by Medicare Conditions of Participation. cooperate with tissue banks that have agreements with hospitals and critical The surveyors should review policy documents to ensure that a access hospitals with which the OPO mechanism is defined for referring eye and tissue referral calls to the has agreements. The OPO must appropriate eye or tissue bank, including any written arrangements cooperate in the following activities, as with an answering service, if necessary. The surveyor should also may be appropriate, to ensure that all interview appropriate OPO employees (or answering service usable tissues are obtained from employees, if necessary), and examine referral call worksheets and potential donors: practices to ensure that information is appropriately and timely

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screening and referral of potential transferred to an eye bank or tissue bank. donors, obtaining authorization from families of potential tissue donors, retrieval, processing, preservation, storage and distribution of tissues, and providing designated requestor training.

AS 11 CORPORATE COMPLIANCE The OPO will have a program or Identify either administrative policy or components in existing policies process which affirms its commitment that identify OPO procedures to: train staff and board, report non- to uphold the internal and external laws compliance, record actions taken when non-compliance is identified, by which it is governed. document corrective action. Examples of such policies may include physician credentialing, quality review policy, policy for reporting adverse outcomes. In general, the OPO should have identified a chain of authority for reporting non-compliance.

A corporate compliance program should be designed to promote integrity and ethical behavior in the OPO. The program should involve a documented commitment from the highest level of the organization, the OPO governing Board of Directors (or the hospital administration, in the case of a hospital based OPO), down through all staff members.

A plan can be tailored to meet the size and needs of the OPO, but there should be evidence of the following components: - Defined standards of conduct in an OPO governing Board-approved document (or hospital administration, in the case of HOPOs). - Oversight responsibilities (i.e., high level personnel designated as the corporate compliance officer) - Criminal/OIG sanctions checks on all employees with a high degree of discretionary authority

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- Implementation of effective on-going training programs for the Board (if not a HOPO) and staff - Monitoring and auditing processes (i.e., system in place, such as a hotline, to receive complaints of on-compliance. Defined auditing process to monitor compliance in identified areas) - Enforcement and discipline (i.e., consistent enforcement of corporate compliance standards/policies; range of disciplinary actions should be identified) - Investigation and prevention of recurrence of non-compliance (i.e., process to investigate the report of non-compliance and ways that recurrence will be avoided in the future)

Further guidance can be obtained by reviewing the following websites: The original guidance document was published 2-23-1998 can be found at: http://www.oig.hhs.gov/authorities/docs/cpghosp.pdf

Supplemental guidance was published 1-27-05 and can be found at: http://www.oig.hhs.gov/fraud/docs/complianceguidance/012705HospS upplementalGuidance.pdf

Sanctions: www.oig.hhs.gov/fraud/exclusions.html

AS The OPO must have a plan of conduct There should be evidence of a formal document, adopted by the OPO 11.1 for its employees and board members. governing Board of Directors (or hospital administration, in the case of This plan is designed to prevent a hospital based OPO), which outlines standards specific to particular accidental and intentional non- activities. The document should describe the conduct that is either compliance with applicable laws; to required or prohibited in relation to that activity. Policies and detect such non-compliance if it procedures must be present that define how suspected incidents of occurs, to discipline those involved in non-compliance can be reported, and that reports can be made without

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non-compliance behavior, to prevent fear of retribution. Statements should be present that define the range future non-compliance, and establish of discipline that may occur with non-compliance. Mechanisms, such and implement a corrective action plan. as how investigations are conducted and what is done with the information in the investigation, should be in place to prevent future non-compliance. All of the parts of the standard must be present in order to meet the standard. AS The OPO shall define the monitoring 11.2 and auditing systems as well as other evaluation techniques which fulfill the plan’s requirements. AS Reporting There should be a system in place for the reporting of reasonably 11.2.1 suspected incidents of non-compliance. Evidence of a mechanism for Board (if not HOPO), staff or agents to report non-compliance should be available, and staff should be familiar with the process for reporting. AS Tracking There should be a tracking system defined for reports of non- 11.2.2 compliance. A statement that the organization does not tolerate any form of retaliation against those who report non-compliance needs to be documented in personnel or corporate compliance policies. There should be baseline and periodic audits that determine areas of risk for non-compliance. We recommend that the OPO look at all recorded incidences. AS Auditing A baseline audit should be present that identifies areas of risk for non- 11.2.3 compliance. This can be done in a variety of ways, depending on the size of the OPO (i.e., by department, overall organization, training effectiveness). The size of the audit and what is identified will vary between OPOs, but there should be common elements for all OPOs (i.e., federal, state and local laws/regulations, industry specific standard, billing policies/procedures/training, background checks, contract/agreement language, etc.). AS The OPO shall have a written protocol The protocol should identify what steps the OPO will take to respond to 11.3 for investigation of suspected non- reported noncompliance, including who will conduct the investigation

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compliance with its plan. The plan and where the information will be reported. Since non-compliance must include procedures for the OPO incidents may range from general to criminal, many plans may include to take prompt action in response to when to consult with legal counsel, and the appropriate oversight any violation once they are detected body/agency will be contacted as necessary. There should be and steps to prevent future non- language that calls for a corrective action plan for all reasonably compliance. suspected reports on non-compliance and that steps will be taken to prevent similar situations in the future. There should be evidence that the investigative process will be kept, to the extent possible, confidential. SAFETY STANDARDS Interpretive Guidelines Objective Evidence Related to the Standard SS 1.0 Exposure Control Plan The employer is to develop a written exposure control plan. SS 1.1 Identify tasks and procedures where exposure may occur SS 1.2 Identify the job classifications whose duties include those tasks SS 1.3 Procedure for evaluating the circumstances surrounding exposure incidents SS 1.4 Documented consideration and implementation of appropriate commercially available and effective internal controls. SS 1.5 Documentation that direct patient care employees input was sought in evaluation and implementation of internal controls and standards of

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practice (safety committee, surveys informal groups, audits, pilot testing etc.) SS 1.6 Exposure control plan clearly identifiable and available to employees. SS 1.7 Documentation that the plan is reviewed and updated annually (review includes documentation of incorporation of new standards, new or modified tasks, new job classifications, newly available medical devices for prevention)

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SS 1.8 Schedule for implementing sections of the standard covering the methods of compliance, hepatitis B vaccination, post-exposure follow- up, communication of hazards to employees, and record keeping SS 2 Universal Precautions Universal Precautions must be observed. Employer and employees are to assume that all human blood and specified body fluids are infectious for HIV, HBV, and other bloodborne pathogens. SS 2.1 Policy written requiring use of PPE in all cases.

SS 2.2 Is policy followed? (review needle stick logs, injury logs when employee information has been redacted) SS 3 Personal & Protective Equipment PPE must be used if occupational exposure remains after instituting work practice controls, or if those controls are not feasible. SS PPE are provided free to OPO staff. PPE exist in appropriate sizes 3.1 and are accessible to staff. Hypo-allergenic product must be available for those with latex allergies/sensitivities. Gloves must be FDA approved. Baggie gloves may not be used. PPE must be laundered/cleaned by employer

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SS 3.2 Ask employee to demonstrate appropriate use of PPE. Ask employees going to hospitals about PPE. Do employees use hospital PPE at hospitals in ICU and OR? Ask employee to demonstrate appropriate removal and decontamination of PPE Employer investigates and documents every instance where appropriate PPE was not used. (Review Occurrence Reports) Policy exists and outlines the following precautions for safely handling and using PPE:  Removing PPE before leaving the work area and after a garment becomes contaminated  Placing used PPE in appropriately designated areas or containers when being stored, washed, decontaminated, or discarded  Wearing appropriate gloves when it can be reasonably anticipated that the employee may have contact with blood or other potentially infectious materials  Replacing gloves when torn, punctured, contaminated or when their integrity is compromised  Prohibiting washing or decontamination of disposable gloves for reuse  Wearing appropriate face and eye protection such as mask with glasses with solid side shields or a chin-length face shield when splashes, sprays, spatters, or droplets of blood or other potentially infectious materials pose a hazard to the eye, nose, or mouth  Wearing of gowns, aprons, caps, and boots when occupational exposure is anticipated.  Scrubs and lab coats are not meant to be PPE.

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SS 4 Internal controls and standards of practice Internal and work practice controls are the primary methods used to prevent occupational transmission of HBV and HIV. PPE are necessary when occupational exposure to bloodborne pathogens remains even after instituting these controls. SS 4.1 Documentation that sufficient internal controls and standards of practice are used. SS 4.2 Review injury reports (if employee information has been redacted). SS 4.3 Review evaluation questionnaires, pilot studies, published data used in establishing Environmental Controls and Work Practices. SS 4.4 Documentation that regular inspection occurs –inspection of face shield for cracks, are present etc. SS 5 Handwashing Facilities SS 5.1 Staff has ready access to soap and tepid water

SS 5.2 Policy requiring employees to wash hands after gloves are removed exists? SS 5.3 Policy requiring employees to wash hands after contact with blood or other potentially infectious materials exists? SS 6 Safety SS 6.1 Contaminated Sharps Policy exists and states that shearing, breaking, bending, recapping and removal is expressly prohibited and that any exception must be documented in writing along with the justification and supporting evidence that no feasible alternative existed SS 6.2 Reusable Sharps Containers exist for contaminated scalpels, saws etc. and they meet the same requirements as containers for disposable sharps, except

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they need not be closeable since they will be reused. Documentation of evaluation of these containers exists. SS 6.3 Food & Drink Policy exists and states that no food or drink is allowed in the work area. Hand washing procedures are followed.

SS 6.4 Spraying, Splashing Power tools, electro-cautery devices etc. should be evaluated for potential to contaminate employees or work surfaces. Appropriate PPE and clean up required. SS 6.5 Mouth Pipettes Policy exists prohibiting mouth pipettes. Mechanical pipettes exist for OPO Laboratory staff. SS 6.6 Labeling All specimens must be properly labeled in transit from or to OPO. A fluorescent orange or orange-red Containers must be evaluated for leakage, punctures. warning label is to be attached to containers of regulated waste, refrigerators and freezers containing blood and other potentially infectious materials, and to other containers used to store, transport, or ship blood or potentially infectious materials SS 7 Housekeeping The employer must develop and implement a cleaning schedule that includes appropriate methods of decontamination and tasks or procedures to be performed. The written schedule must be based on the location within the facility, the type of surfaces to be cleaned, the type of contamination present, the tasks or procedures to be performed, and their

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location within the facility. SS 7.1 Policy Policy exists and ensures that the following housekeeping procedures are followed:  Cleaning and decontamination of all equipment and environmental and work surfaces that have been contaminated with blood or other potentially infectious materials. (Inspect cleaning schedules in Dirty Room and Laboratory)  Work surfaces are decontaminated with appropriate disinfectant  Inspect and decontaminate on a regular basis, reusable receptacles such as pails, bins, cans, etc.  Use of mechanical device to pick up contaminated broken glassware and not hands even if gloves are worn  Storage of reusable sharps that ensures safe handling  Placement of regulated waste in closable and labeled containers that are also leakproof  Ensure that sharps containers are easily accessible to staff and located as close as is feasible to the immediate area where sharps are being used; sharps containers are kept upright throughout use, replaced routinely, closed when moved, and not allowed to overfill  Prohibits manually opening, emptying, or cleaning reusable contaminated sharps disposal containers  Contaminated laundry is handled as little as possible; PPE used when handling contaminated laundry; contaminated laundry is bagged at its location of use and placed in leak-proof containers prior to transporting

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SS 7.2 Demonstration Ask available staff to:  Demonstrate proper procedure for cleaning up contaminated broken glass.  Demonstrate proper procedure for cleaning up spill.  Demonstrate proper, safe decontamination of equipment, glassware etc. SS 8 Regulated Waste SS 8.1 Check for appropriate use of red bags, labels, documentation for disposal SS 8.2 Check for appropriate sharps containers, lids, overfilling, color- coding, labeling, height, accessibility to staff. SS 8.3 Ask available staff to:  Demonstrate proper disposal of sharps and sharps containers (close lid securely, check for leakage, dispose of in medical waste containers)  Demonstrate knowledge of double-bagging technique (assume red-bag leaked into garbage container)  Demonstrate proper disposal of PPE SS 8.4 Check that autoclave logs are properly filled out. Date, time, operator, temp.

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sensitive tape results, dates and results of calibrations, results of routine spore testing. SS 9 Hepatitis B Vaccine The employer must make the hepatitis B vaccine and vaccination series available to all employees who have occupational exposure as well as provide a post-exposure evaluation and follow-up to all employees who experience an exposure incident. SS 9.1 Verify it is made available at no cost to all (part-time and per diem) appropriate employees within 10 working days of initial assignment SS 9.2 Verify that the vaccination and follow- up fall within CDC guidelines SS 9.3 . Verify presence of signed declinations. Does declination document meet guidelines? SS 9.4 Verify that a post-exposure incident plan is in place and that it assures immediate and confidential evaluation, prophylaxis and follow-up. SS 9.5 Verify that Exposure Incident reports and P&P meet standard. SS 9.6 Verify Needlestick Injury Log

SS 9.7 Verify OSHA 300 reporting annually

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SS 9.8 Create vendor questionnaire to assure vendors are providing services per OSHA standards and that requirements are met. For exp. We assume they are providing something and they assume we are. SS 10 Recordkeeping SS 10.1 Employer must preserve and maintain Under the bloodborne pathogens for each employee an accurate record standard, medical records must include of occupational exposure according to the following information: OSHA’s rule governing access to  Employee name and social employee’s exposure and medical security number records.  Employee’s hepatitis B vaccination status including vaccination dates and any medical records related to the employee’s ability to receive vaccinations  Results of examinations, medical testing, and post- exposure evaluation and follow- up procedures  Health care professional’s written opinions  Copies of information provided to health care professionals SS 10.2 Assure that all staff medical records are in a file separate from employee files. SS 10.2 Assure that medical records are being kept confidential and are maintained for

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at least the duration of employment plus 30 years. SS 11 Archiving Serum Tissue Samples Check for policy defining the need to archive specimens and ask for The OPO shall assure that appropriate documentation. Documentation may require a visit to lab or written tissue samples (for example, if using reports from lab/agency that OPO has relationship with for archiving. sera or plasma, it should be pre- There must be a unique identifier that correlates to OPO donor transfusion or other hemopoetic tissue) identification. The surveyor will identify dates of policy and date of sera or plasma remaining from every standard and assure that since that date all specimen have been recovered donor shall be archived for a archived. If there is not sufficient quantity of sera or plasma to archive, period of at least10 years after the date this must be documented in the OPO's inventory of the archived of recovery. This serum must be specimens. available for use for retrospective testing. SS12 Refrigerator Storage The OPO shall Check for adequately maintained logs of refrigerator temperature maintain a log of temperature records monitoring. Assure that staff are trained on how to monitor and respond for supplies requiring temperature in the event that alarms or desired temperature limits are exceeded. controlled storage and show evidence of training of the appropriate personnel for this purpose.

CLINICAL STANDARDS

CL 1 RESPONSE TO REFERRALS The Organ Procurement Organization shall have policies and procedures to respond to referrals of potential donors in a prompt, professional and standardized manner. This applies to all personnel, including donor coordination staff, surgical recovery team members.

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CL 1.1 The OPO shall document availability of Presence of a methodology to assess trained personnel at all times to receive new employee’s all referrals of potential donors. readiness to assume call responsibilities on an independent basis (assessing “trained”);

Published call schedule that denotes coordinator on call. Schedule should provide adequate daily coverage for organ recovery. Assure that there are sufficient numbers of qualified organ procurement coordinators employed by the OPO.

Demonstrated competency.

CL 1.2 The OPO response to referrals will be Assess for a written policy regarding consistent with triggers established with donor referral response. Ask the donor hospitals for referral. The coordinator to verbally outline the OPO shall document prompt and OPO’s policy and how it is efficient response to the referral. This implemented in practice. Surveyor will will include establishing procedures to compare response time to clinical direct the Coordinator in handling the triggers used by OPO and donor referral of a potential donor. hospital.

CL 1.3 The OPO shall ensure that it responds to the referral in a professional manner that will facilitate the evaluation of the donor for both the OPO and the donor hospital.

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CL 1.4 The OPO shall comply with OPTN Presence of a systematic mechanism requirements for referral to assess donor referral information in documentation. compliance with OPTN requirements.

CL 2 VERIFICATION OF DEATH The OPO shall assure that death has been legally determined and documented in the donor's medical record. CL 2.1 The OPO shall adhere to all local Request documentation of state/federal and/or state statutes. laws related to organ donation; ask for evidence that information on these laws is included in coordinator training; quiz employees on above information. CL 2.2 The OPO policy shall ensure that the Assess presence/content of policy determination and documentation of regarding documentation death is verified and recorded in the of death; check a minimum of 10 charts donor's hospital medical record, in or 10% of donors if > 100 donors/year accordance with the hospital's policy for at random for proper documentation of determination of death. death in chart copy; request documentation of individual donor hospital policies on organ donation and pronouncement of death.

CL 3 AUTHORIZATION FOR DONATION OPO personnel shall ensure that Site surveyor should examine OPO authorization for donation is obtained in policy and definition on authorization, compliance with the OPO’s policies and interview staff for compliance. regarding authorization.

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CL 3.1 OPO personnel shall have documented Request documentation to demonstrate training regarding obtaining and coordinators have received training in documenting authorization for donation. family approach/obtaining authorization. CL 3.2 Authorization must be documented Quiz coordinators as to knowledge of and obtained from the next of kin or appropriate next of kin. other legal entity as designated in order of priority and availability according to If not able to verbalize – assess ability the applicable state or local statutes to obtain information from available (i.e., Uniform Anatomical Gift Act). resources.

Assess presence/content of OPO policy regarding medical examiner involvement.

CL 3.3 A copy of signed authorization form Either the original or a copy shall be must be retained in the OPO donor filed in the OPO donor file, depending record. upon local law, donor registry and OPO policy. Chart review is conducted here to determine presence of a legal document of gift or signed authorization.

CL 3.3.1 OPO shall have a defined effective Through interview and policy request process and that process is assessment, surveyor will be able to standardized. identify the OPO’s request process and assess how it is followed. CL 3.4 Authorization form for organ donation Review authorization form to lists specific organs for which determine that either: authorization for removal is being given.  Each specific organ and tissue is

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named and properly identified as to whether authorization has been given or denied to recover that specific organ or tissue; or

 An opportunity is provided for the family to either:

1. Selectively grant or deny authorization to recover any specific organ or tissue; or 2. Indicate authorization for any needed organ or tissue; or 3. A combination of 1 and 2 above  Look for policy outlining what constitutes authorization for the OPO. CL 3.5 The OPO shall ensure that Review correlation between authorization for organ and/or tissue authorization process in comparison to donation is documented on an local hospitals and/or state authorization form or legal document of requirements. gift that meets both hospital policies and the legal requirements of the local jurisdiction in which authorization is being obtained. CL 3.6 The OPO has a policy that specifies Quiz coordinators as to proper where the original signed authorization distribution of original authorization or form or hardcopy of donor designation donor designation form and is to be filed (usually either in the subsequent copies (hospital, OPO OPO’s donor record or in the donor’s chart, ME, tissue banks, etc.). Look for hospital medical record). a policy outlining the process for

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obtaining written authorization vs. utilization of a donor registry, if applicable.

CL 3.7 The OPO shall have a policy and Assess local guidelines for what is procedure for medical reportable to ME/coroner; check to see examiner/coroner contact. if there is a log.

CL 4A Guidelines for Evaluation and Request written documentation on Management of Potential Deceased policy making. The OPO's organ donor Organ Donors evaluation and management policies Evaluation and management of donors and procedures must be reviewed at shall meet the OPTN standards and set intervals and exhibit written requirements in effect at the time of the approval by the OPO Medical Director donor recovery. and/or the OPO Medical Advisory Committee (or its equivalent). Current standards did not require written approval of the OPO's policies & procedures for donor evaluation and management. Look for minutes of committee meetings, or written policy documents evidencing approval. CL 4A.1 The OPO's organ donor evaluation and management policies and procedures must exhibit written approval by the OPO Medical Director or the OPO Medical Advisory Committee (or its equivalent). CL 4A.2 These procedures are to be undertaken with medical supervision and support as necessary.

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CL 4A.3 OPO personnel will have documented training regarding donor evaluation and management that includes training to obtain a medical and social history. CL 4A.4 Once the patient has been declared dead, or death is imminent, and authorization for donation has been obtained, the OPO should implement the guidelines for the evaluation and management of the potential organ donor. CL 4B The evaluation of the donor shall Request documentation on written include: policies regarding the acquisition of outlined information;

All charts contain a medical and social history form that satisfies the USDHHS/CDC Guidelines;

An inquiry designed to gain insight into the donor’s medical behavioral and sexual history shall be conducted with the potential donor’s next of kin, significant life partner and/or other appropriate individuals utilizing a standardized history questionnaire. Questions shall be designed using the USPHS “Guidelines for Preventing Transmission of HIV Through Transplantation of Human Tissues and Organs” (MMWR: Vol 43, No. RR-8,

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May 20, 1994);

Review of a current chest x-ray for the purpose of ruling out metastatic pulmonary lesions. Provides additional requirement to ensure clinical safety of the potential transplant.

CL 4B.1 An inquiry designed to gain insight into the donor's medical, behavioral, and sexual history shall be conducted with the potential donor's next of kin, significant life partner and/or other appropriate individuals utilizing a standardized history questionnaire. Questions shall be designed using the USPHS "Guidelines for Preventing Transmission of HIV Through Transplantation of Human Tissues and Organs," (MMWR: Vol.43, No. RR_8, May 20, 1994). CL 4B.2 Documented physical examination CL 4B.3 Documentation of ABO group (and subgroup, if applicable), weight and height. CL 4B.4 Review of current inpatient medical record CL 4B.5 Documentation of significant events in the clinical course. The current hospital history shall include: CL 4B.5.1 Description of injuries and treatments

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(i.e., surgeries) CL 4B.5.2 Account of significant febrile episodes, duration, treatment, and response. CL 4B.5.3 Account of any cardiac or respiratory arrests, type, duration, and treatment required to restore function CL 4B.5.4 Record of administration of blood products, type and amount. CL 4B.6 Review of a current chest x-ray for the purpose of ruling out metastatic pulmonary lesions. CL 4C The OPO shall ensure that optimal respiratory, hemodynamic and electrolyte management of the donor is provided. The donor file shall include the donor's hemodynamic status. CL 4C.1 Documentation of blood pressures shall include: CL 4C.1.1 Average pressure CL 4C.1.2 any hypotensive periods noting lowest pressure and duration CL 4C.1.3 use of vasopressors, type, amount, duration, and response CL 4C.1.4 any periods of prolonged hypertension, highest pressure and duration, and treatment instituted. CL 4C.2 Documentation of abnormal heart rhythms and treatments. CL 4C.3 When available, pulmonary and central venous pressure readings shall be

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documented and correlated with blood pressure. CL 4C.4 Electrolytes CL 4D The OPO shall ensure that proper Request documentation on agreements antibiotic coverage, infectious disease with tissue typing testing, and tissue typing is conducted. laboratories:

Assess responsibilities of each party (OPO and tissue typing lab) as outlined by agreement

Assess approval status of HLA lab(s) by UNOS

Quiz coordinator staff on practices involved in the supply of tissue to lab. CL 4D.1 The OPO shall ensure that the donor receives appropriate antibiotic coverage, if a need is indicated. CL 4D.2 The OPO shall evaluate the infectious Review state laws for the OPO disease status of the potential donor. regarding the reporting of serologic Serological testing should be noted to tests. Current standards do not provide be either pre or post transfusion. OPO a strongly worded requirement for Medical Director and/or the OPO notification of any positive infectious Medical Advisory Committee (or its disease testing on the donor. This equivalent) establish policies in standard will cause the OPO to develop conformance with Federal and State a specific policy and procedure for law regarding notification of positive handling positive test results. (confirmed) donor test results. Communication regarding test results shall be documented in the donor

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medical record. Evaluation shall include, but not necessarily be limited to: CL 4D.2.1 Serological testing according to current UNOS/OPTN policies and/or procedures CL 4D.2.2 Urine cultures CL 4D.2.3 Blood cultures CL 4D.2.4 Cultures of preservation solutions that are in contact with the kidney(s) at the end of the surgical recovery should only be done if there is a question of a break in sterile technique during the procedure. CL 4D.2.5 CBC CL 4D.3 For those organ systems for which the OPO assumes responsibility for tissue typing, the OPO must have arrangements for tissue typing and must ensure that tissue typing is performed, by an affiliated, OPTN approved histocompatibility laboratory and tissue typing material is provided to said laboratory for testing. (Ref. UNOS Bylaws, Attachment 2-4, Appendix B.)

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CL 4D.4 Documentation of communication in a timely fashion with the transplant center(s) of positive cultures and biopsy results. Unless otherwise directed by state or local regulations, the donor's next of kin or a physician who will counsel the next of kin shall be notified of any confirmed positive serological test results that may be medically relevant as determined by the OPO Medical Director. All other transplant and/or research organizations involved with the donor shall be notified of any positive confirmed test results in a timely manner. CL 4E The OPO shall ensure the evaluation of all medically suitable transplantable organ systems. Such evaluation shall include (if obtainable), but not be limited to: CL 4E.1 Kidney evaluation: CL 4E.1.1 Urinalysis CL 4E.1.2 Creatinine CL 4E.1.3 B.U.N. CL 4E.2 Heart Evaluation: CL 4E.2.1 12 Lead EKG CL 4E.2.2 Chest X-ray CL 4E.2.3 Arterial Blood Gases

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CL 4E.2.4 Echocardiogram CL 4E.2.5 Cardiology Consult CL 4E.3 Liver Evaluation: CL 4E.3.1 Liver Enzymes CL 4E.3.2 PT CL 4E.3.3 Total and Direct Bilirubin CL 4E.3.4 Blood group subtyping of ABO=A donors (ref UNOS Policy 2.2.7.3) CL 4E.4 Pancreas Evaluation CL 4E.4.1 Glucose CL 4E.4.2 Serum amylase and Lipase (Ref. UNOS Policy 2.2.7.5) CL 4E.5 Lung Evaluation CL 4E.5.1 Arterial Blood Gases CL 4E.5.2 Chest X-ray with interpretation and measurements CL 4E.5.3 Sputum Gram Stain/culture or mycology smear CL 5 ALLOCATION OF DONATED ORGANS Organs shall be allocated according to the standards of the Organ Procurement and Transplantation Network (OPTN) and in keeping with approved local variances. CL 5.1 The OPO shall have written Request documentation of any UNOS approved variances for documentation of an OPTN organ allocation (each organ). approved allocation system for each donated organ for transplant

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(if a local variance is in effect). CL 5.2 The OPO shall document that the Assess that the match run in UNet was utilized for allocation of organs; OPTN computer was accessed for this is done by accessing the printout in the OPO donor chart, or a donor/recipient match run on asking the OPO staff to access UNet for verification. every donor organ procured by the OPO. CL 5.3 Organs shall be allocated by the Verify compliance by requesting UNOS compliance letters; ask OPO to OPO utilizing the sequence of demonstrate, using 2 – 3 charts, that they utilize the PTR in UNet. patients as determined by OPTN computer or by approved variance. CL 5.4 Any variation from the OPTN Determine if any organ allocation practices occur outside guidelines donor/recipient match run shall be approved by UNOS. If so, assess that these occurrences are fully documented and become a documented in donor chart. Look for a policy describing the handling of permanent part of the donor or discrepancies and interview staff on that process. quality assurance record.

CL 5.5 Documentation of actual allocation Assess UNOS donor registration forms are correctly completed and of each organ procured shall be filed in a timely manner. Ask for UNET compliance report. filed in accordance with OPTN guidelines. CL 6 OPERATING ROOM PROCEDURES The OPO shall have standards to facilitate and coordinate the recovery of donated organs. CL 6.1 The OPO shall ensure that any The OPO should have an established Code of Conduct describing surgeons working as consultants to what professional behavior is. An example is the AOPO Code of the OPO for the recovery of Conduct, developed by the Medical Directors’ Council. Assess OPO’s donated organs (i.e., surgeons methodology for ensuring that all surgeons meet qualification criteria. whose fees are paid by the OPO) meet qualifications and standards

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as set by the OPO Medical Director and/or its Medical Advisory Committee or its equivalent. CL 6.2 The OPO must have protocols in Assess the OPO’s methodology for maintaining the credentialing, place for quick verification of the and/or qualifications and training documentation. The OPO may use credentialing and/or qualifications AOPO’s ACIN database, or some other method, for surgeons outside and training of recovery personnel the OPO’s service area. prior to any recovery. Documentation of the verification must remain on file and confirm that verification was done before recovery. CL 6.3 The OPO shall have a mechanism Assess mechanism by which Medical Director reviews standards and to review and document the technical quality of recovery surgeons. surgical recovery of organs, addressing adherence to standards Issues such as surgical errors and inappropriate conduct are and technical performance of the addressed, documented and reported by the Medical Director of their surgeons providing consulting designee to the OPO. services to the OPO. CL 6.4 The OPO is responsible for Do OPO personnel provide anesthesia with information on the coordinating anesthesia support for following guidelines: the organ recovery process. The OPO shall document the provision of information/guidelines to anesthesia for the intra-operative procedure. The goal of this intra- operative support includes:

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CL 6.4.1 Maintaining an adequate blood Acceptable parameters for BP, CVP, organ profusion and function. pressure, fluid volume, organ perfusion and function. CL 6.4.2 Oxygenation of the organs being Acceptable oxygenation parameters recovered is documented. CL 6.4.3 Replacement of excessive volume Acceptable parameters for fluid replacement loss. CL 6.4.4 Administration of required and/or Acceptable parameters for pharmacological desirable medications to facilitate Intervention organ recovery and function. CL 6.5 The OPO is responsible for Assess written policy for compliance with UNOS standard. packaging and labeling organs, Interview members of coordinator staff regarding packaging tissue typing material and blood, procedures. according to OPTN standards and OSHA regulations. CL 6.6 The OPO is responsible for Assess written policy to determine compliance with information distributing the following sharing/documentation requirements. Policy should require OPO to documentation to each transplant provide the following to each transplant team: team at the time of recovery of an organ from an individual donor: CL 6.6.1 Verification of donor ABO type CL 6.6.2 Copy of death determination from the donor’s medical record. CL 6.6.3 Copy of authorization for organ recovery from the donor’s medical record or document of gift. CL 6.6.4 Copy of the OPO donor information as described in CL.13. CL 6.7 The OPO assures that an operative Check for copy of operative procedure note. Assess written policy procedure note is provided by the and procedure for compliance with this standard.

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recovery surgeon for the donor's hospital medical record and OPO record. CL 6.8 The donor file shall document the events surrounding the surgical removal of all organs, including the following intraoperative information: CL 6.8.1 Blood products administered, type, amount CL 6.8.2 Type and amount of flush solutions and flush characteristics CL 6.8.3 Warm ischemia time CL 6.8.4 Type of storage solution CL 6.8.5 Type of recovery procedure; i.e., kidneys – en bloc, in situ flush CL 6.8.6 Aortic cross-clamp time and date CL 6.8.7 Description of typing material available CL 6.8.8 Anatomical description CL 6.8.8.1 Kidneys – (unless en bloc) include number of vessels and approximate length and diameter of each CL 6.8.8.2 Extra-renals – include a description of any injuries or abnormalities CL 6.8.9 Organs retrieved and disposition

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CL 7 USE OF PORTABLE Essential for OPO’s using hand-held analyzers: LABORATORY TESTING DEVICES The policies and procedures must be available to the person OPO’s that utilize bedside performing the test when that person is performing the test. laboratory testing must define the appropriate use of such testing, Reference to the manufacturer’s manual is acceptable if appropriate and establish appropriate policies modifications have been made to tailor it to the OPO’s need. and procedures for its use. CMS had determined that OPOs that are managing potential organ donors do not have to comply with CLIA-88. The Clinical Laboratory Improvement Amendments of 1988 establish specific requirements of individuals and laboratories which perform analysis of bodily fluids that could impact any decision for patient care. These requirements include academic training of the person performing the test, competency training and orientation and adequate control testing. It is important for AOPO to establish minimal guidelines to assure competency of those using the bedside laboratory equipment and to assure that those using the equipment do not violate the specific guidelines of CLIA-88.

Ask for evidence of a current CLIA license or certificate and that there are job descriptions for the Lab Director and Technical Director. Ask to see contracts/letters of agreement for their services, if applicable. CL 7.1 The OPO has defined in writing which laboratory bedside test will be performed on potential organ donors. CL 7.2 Laboratory bedside testing methods classified as acceptable for the management of an organ donor under federal law and

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regulations meet the following requirements: The extent for which test results are used in the management of an organ donor (definitive or as a screen) are defined by the OPO and approved by the OPO's medical director. Specifically, the OPO has determined the extent to which bedside laboratory testing will be used for diagnosis, treatment, or screening with or without follow-up using confirmation testing. CL 7.3 OPO staff responsible for bedside laboratory testing performance and those responsible for direction/supervision of the testing activity is defined. CL 7.4 OPO policies and procedures must exclude any bedside laboratory testing on any individual other than a declared dead potential organ donor. CL 7.5 OPO staff performing laboratory OPO staff performing laboratory test must have adequate, specific test must have adequate, specific training and orientation to perform each individual beside tests and training and orientation to perform demonstrate satisfactory levels of competence. Look for each individual beside test and training/proficiency testing in accordance to CLIA standards. demonstrate satisfactory levels of competence. CL 7.6 The OPO must have current written policies and procedures that are

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readily available and address the following: specimen collection, specimen preservation, instrument calibration, quality control and remedial action, equipment performance evaluation, test performance CL 7.7 Quality control checks are conducted on each procedure in a time frame defined by the organization. At a minimum, the manufacturer’s instructions are followed. CL 7.8 Appropriate quality control and test records are maintained for a defined period of time. CL 8 COMMUNICATION OF PAST MEDICAL HISTORY AND RISK FACTORS Look for documentation in the donor files that the donor’s past medical The OPO documents that the history and any knew risk factors have been timely communicated to recipient center(s) are informed in a all recipient centers. Look for policy statements requiring this action. timely basis of the donor's past medical history and any known risk factors, including high risk factors as defined by the CDC, which are present in the donor or donor organ(s). CL 9.0 DONOR FILE The OPO shall maintain a separate Look for a policy statement that meets the requirement. Determine if file for each donor. any state law adds further retention requirements. Ask to see or visit

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area where records are kept to ascertain that the minimum retention requirement is being met. The OPO shall compile the CL 9.1 following information on each donor: CL 9.1.1 Name CL 9.1.2 Age, sex, race, ABO and HLA if kidneys are recovered CL 9.1.3 Cause of death CL 9.1.4 Time and date of hospital admission CL 9.1.5 Time and date of pronouncement of death CL 9.1.6 OPTN ID number CL 9.1.7 OPO ID number, if the OPO uses a separate identification system. CL 9.1.8 Copy of declaration of death note CL 9.2 The OPO shall document the following information for purposes of follow-up: CL 9.2.1 Name and address of the legal next-of-kin and relationship (or person with legal authority to give authorization) CL 9.2.2 Name of attending and consulting physicians CL 9.2.3 Name of medical examiner or coroner as applicable CL 9.2.4 Names of hospital personnel involved in the donor process.

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CL 9.3 The donor file that documents donor suitability, organ recovery, preservation, quality assurance, and distribution shall be retained a minimum of 10 years and/or in compliance with state laws beyond the date of organ recovery. Records shall be maintained in an appropriate manner in such a way as to preserve their contents. CL 10 DOCUMENTATION OF DONOR HISTORY The OPO shall include in the record the donor's current hospital history, past medical and behavioral history. CL 10.1 The documented past medical history shall, when available, include significant episodes of the following: CL 10.1.1 any previous hospitalization CL 10.1.2 any prior surgery CL 10.1.3 history of a chronic illness, e.g., diabetes, hypertension, cardiovascular disease, etc. CL 10.1.4 History of communicable disease, e.g., hepatitis CL 10.1.5 History of disease specific to transplantable organs and treatments for it.

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CL 11.0 DOCUMENTATION OF VOLUME STATUS The donor file shall document information on volume intake and output. CL 11.1 The OPO shall document volume intake - type (Crystalloid, colloid, blood and blood products) and amount - for a minimum of 8 hours prior to recovery, if possible, and for the duration of the recovery period. CL 11.2 The use of any blood or blood products shall be noted. CL 11.3 The OPO shall document urine output for a minimum of 8 hours prior, if possible, to recovery and for the duration of the operative period. CL 11.4 Any periods of oliguria, anuria, or the occurrence of diabetes insipidus (and its treatment) shall be documented. CL 12 DOCUMENTATION OF RECIPIENT INFORMATION The donor file shall document recipient information prescribed by OPTN guidelines, in effect at the time of the donation. CL.12.1 The following information shall be documented on each recipient:

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CL 12.1.1 Name CL 12.1.2 Recipient Center CL 12.1.3 Age, sex, race, ABO CL 12.1.4 Organ type and function at time of transplant CL 13 DOCUMENTATION The OPO shall utilize a standard format to document all required donor METHODOLOGY information. This format may be paper or electronic and in either form The OPO shall utilize an internal shall meet all of the requirements set forth in the standard. standard format or form (OPO Donor Information Form) to document all clinical donor records, shall submit all required OPTN documents according to prescribed time frames, and shall maintain adequate security for all medical records. CL 13.1 All corrections or additions to the donor record must be made with a single line through the altered text, initialed and dated by the individual making the correction. CL 13.2 All donor records shall be During medical record review, check for entries in ink only and assure completed using ink. All donor that whiteout or complete scratch outs are not present. Check to see chart items must be completed (a that all corrections are dated and initialed. Check to ensure that no strike-through line of "N/A" is an items are left blank. acceptable entry). CL 13.3 All currently existing OPTN forms shall be completed by the OPO and submitted to the OPTN contractor within the prescribed time limits.

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CL 13.4 The OPO shall have a system to The OPO must have a policy on who can access the medical records, ensure the security of its medical and how the records are secured after normal business hours. The records. policy should outline procedures for copying records and removing records from the OPO premises. The policy should also detail precautions for utilization of facsimile transmission.

CL 13.5 Process/System Look for policy that will define responsibility and timelines for closing The OPO will have a system or donor records. Also, look for an established system to QA donor process defined by policy that records and then assess that records have gone through the QA and provides for the QA and closure of closure processes as defined by policy. all donor records. CL 14 MACHINE PULSATILE PERFUSION OPO’s that utilize machine pulsatile perfusion for recovered organs must define the appropriate use of this methodology, document its utilization, and establish appropriate policies and procedures for its use. CL 14.1 The OPO has a written policy Look for written policy in the OPO policy and procedures manual. If specifying the criteria by which this is being outsourced, ask to see copies of a contract or agreement organs should be placed on that specifies what is done, pumping records, who offers the kidney, machine pulsatile perfusion. paperwork returned, same parameters, and proof of CLIA approval. If using the service of an accredited OPO, verify current accreditation. If not accredited, audit the other organization’s ability through records in the OPO.

CL 14.2 OPO staff that monitor or Determine, through interview or document review, which employees administer to organs on machine provide machine pulsatile perfusion. Examine personnel folders or pulsatile perfusion have training records of those employees for proper documentation of

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documentation of appropriate having completed training. training for this activity. CL 14.3 Quality control checks are Ask personnel for log of quality control checks performed on each conducted on each perfusion perfusion machine utilized by the OPO. Ask for a copy of the machine in a time frame defined by manufacturer’s instructions regarding minimum requirements for the OPO, and which meet the quality control checks. Since the manufacturer’s instructions may be manufacturer's requirements or minimal, look for compliance with at least those items named in the instructions for its use, including at policy. least the following: Temperature Test; Visual Inspection CL 14.4 The OPO shall document in the Conduct chart review of those donors who meet the OPO policy donor file, and report to the definition requiring machine pulsatile perfusion. Review charts and receiving center, information score for inclusion of required information. If Donation after Cardiac regarding machine readings when Death is performed, pull specific charts to verify pulsatile perfusion, if pulsatile machine perfusion is used applicable. Confirm that pulsatile perfusion record/parameters is on the for any organ. Information AOPO form or attached to the donor record. documented and reported shall include at least the following: CL 14.4.1 Date and time when a kidney is initially placed onto machine preservation. CL 14.4.2 Initial perfusate flow and pressure and temperature CL 14.4.3 Subsequent date and time recordings of perfusate flows and pressures and temperature at regular intervals, and at least each four hours. CL 14.4.4 Date and time when a kidney is removed from machine preservation.

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CL 14.4.5 Final perfusate flow and pressure and temperature when kidney is removed from machine. CL 14.4.6 Name(s) of person(s) recording information in 4.1 through 4.5 above. CL 14.4.7 UNOS ID number on the perfusion record. CL 14.4.8 Type of perfusate used, and any additives or medications added to solution during perfusion. CL 14.4.9 Recorded lot number of cassette with expiration date. CL Recorded lot number of perfusate 14.4.10 with expiration date. CL. 15.0 OPO DCD Policy CL 15.1 OPO must have a DCD policy in Policy should include order to facilitate organ donation  provision for OR or alternate recovery site extubation after cardiac death (DCD).  certification of death using standardized, objective, and auditable criteria that follow state law  provision for patient care if the patient does not progress to asystole in acceptable time frame (i.e., families are told that donation may not be possible. If donation cannot occur, a plan is in place to return the patient to pre-determined unit or floor under the care of attending MD.)  conflict of interest provision CL 15.2 DCD policy should include Death cannot be pronounced, nor orders for sedation ordered, by a statement about pronouncement of member of the procurement or transplant team. death. Policy should include observation of asystole, apnea and

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unresponsiveness for > 2 minutes but not more than 5 minutes

CMS Resource Guidance: A. Interpretive Guidelines §486.344(f)(5)The OPO staff cannot make a death pronouncement. The person making the declaration must be a person authorized to do so by the donor hospital and applicable State laws… The OPO must have written protocols that discuss the wait time between declaration and the beginning of recovery (consistent with current expert recommendations).

B. Interpretive Guidelines §486.344(f)(2)

Once authorization [informed donation consent] is obtained, the OPO should work in collaboration with the donor hospital staff to prepare the family for withdrawal of support and honor the family’s desire to be included as much as possible consistent with hospital policies and protocols. The OPO must have written protocols for its collaboration with the donor hospital staff regarding withdrawal of life support including clear directives as to the responsibilities of the donor hospital staff and the OPO staff in the period of time between extubation and declaration of death. The protocol should state that all recovery personnel (surgeons and other recovery practitioners) are prohibited from entering the operating room until declaration of death. OPO personnel may be in the operating room prior to the actual recovery pursuant to OPTN policy 2.3 which requires that they maintain complete information on any and all organs recovered. The OPO should have written policies consistent with current standards of practice regarding the length of time that must pass from declaration of death and the beginning of recovery.

CL 15.3 OPO must show evidence of a plan Plans should include: to facilitate DCD in their DSA.  assessment of DCD potential  introduction of DCD in selected hospitals

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 education plans for OPO staff and hospital staff re: DCD. DO 1 DONOR FAMILY SERVICES Related to measuring the effectiveness of donor family care programs, STANDARD look for documentation that an assessment of donor family follow-up The OPO shall offer to all organ care is conducted. This may be in the form of a donor family survey donor families a comprehensive, that is distributed on a regular basis to all or a representative sample of time sequenced program of the OPO’s donor families. information and follow-up or organ donation. Survey questions should address the families’ experience with bereavement and follow-up care.

Other means of acceptable assessment may include but are not limited to donor family advisory councils, periodic telephone contact or any means by which donor family feedback is provided.

Related to measuring the effectiveness of donor family care programs, look for evidence of initiatives or revisions to the OPO’s donor family follow-up program which were undertaken as a result of donor family feedback. DO 1.1 Unless the family has asked to Look for a written policy which fulfills the requirement. This policy receive no further information should detail how to document if the family is following donation or is lost to unwilling to participate, has changed their mind about participating in follow-up, the OPO shall have a follow-up, or if the family is lost to follow-up. policy outlining a structured program of donor family follow-up, and which includes a specific number of contacts made by the OPO with the donor family within the first twelve months following donation. DO 1.2 Unless the family has asked to Within the sample of donor charts reviewed, look for documentation in receive no further information the OPO records of a copy of the letter sent, including to whom the

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following donation or is lost to letter was sent, and the date when it was sent. There may also be follow-up, the OPO shall provide a documentation of letters sent to and from the donor family and the written thank you letter to each recipients. These letters may be contained in the donor file itself, or donor family within the first six may be filed in a separate location. If the OPO does not maintain weeks following donation. The copies of each letter, look for evidence of a system used that can letter shall include information substantiate this activity. These could include a template used, desk about which organs were procedures outlining this requirement, or staff interviews which can recovered, and general substantiate this activity. Ascertain that the six week time frame is demographic information about met. each of the recipients made available to the OPO by transplant hospitals. DO 1.3 Unless the family has asked to Look for evidence that donor families are offered follow-up receive no further information bereavement information or contacts. The exact form and frequency following donation, or is lost to of this follow-up information is at the discretion of each OPO. Some follow-up, the OPO shall offer post variability is expected. donation follow-up support to all organ donor families consisting of written materials and/or regularly scheduled activities such as: bereavement support group contact information, bereavement literature, donor family recognition ceremony, etc.

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HOSPITAL DEVELOPMENT STANDARD

HD 1 Potential Donor Assessment OPO has documentation of its ability to assess donor potential, for The OPO shall have example, DRR, cross-referencing. For OPOs which do not do Medical documentation of its ability to Record Reviews, the methodology used to assess donor potential assess donor potential compliance must include all components of HD 1.2. with CMS rule regarding the performance of medical record reviews (MRR). HD 1.1 A written methodology exists to identify the number of potential organ donors and compare the potential with the number of referred and realized donors. HD 1.2 The written methodology in 1.1 above shall include use of a standardized review mechanism which includes documentation of: (1) hospital unit (2) date and time of referral (3) patient demographics (4) cause of death (5) outcome (e.g., medical rule-out, family refusal, donor, etc.) HD 2 HOSPITAL DEMOGRAPHICS All elements of the standard must be included. The OPO shall document and maintain pertinent information on If an OPO is unable to obtain hospital information or if a hospital has each hospital in its service area. no organ potential, documentation must be made available. The Each profile includes the following additional profile needs to reflect current practices and compliance with information: the CMS regulations. Include DCD assessment and brain dead

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potential.

HD2.1 -demographic (type of facility, i.e. teaching, trauma, etc.)

HD 2.2 -number of hospital beds, ICU's, and ICU bed

HD 2.3 -deaths per year

HD 2.4 -referrals, potentials, timely referrals, and donors by year

HD 2.5 -available services (ventilators, acute care, neuro staff)

HD 2.6 -policies and procedures (organ donation, routine notification, brain death, organ donation after cardiac death (DCD), John Doe, coroner and M.E.)

HD 2.7 -referral/donor patterns

HD 2.8 -key contacts

HD 2.9 -hospital agreements/contracts

HD 2.10 -information on donation team/council if applicable

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HD 3 REFERRAL TRACKING The OPO shall maintain a referral tracking mechanism to include:

HD 3.1 -hospital

HD 3.2 -unit

HD 3.3 -name of referring party

HD 3.4 -name of attending physician and/or service

HD 3.5 -outcome referral

HE 3.6 -date and time of referral

HD 3.7 -timely referral

HD 4 HOSPITAL DEVELOPMENT This plan must be evaluated annually at a minimum. Templates may PLANS be used, but for hospitals representing 80% of donor potential, The OPO shall document a plan of customized plans must be made. service in hospitals with any potential for organ donation. This Refer to submitted advance documentation for list of hospitals plan must be evaluated annually at representing 80% of donor potential. a minimum. HD 4.1 Documentation of evaluation of OPO should demonstrate it worked collaboratively with the hospital to hospital needs assessment (via determine needs assessment. As evidence that the plan was done survey, focus group, one-on-one collaboratively, the surveyor may look for evaluation of OPO hospital meetings) must be included. presence, IHC; analyzing and applying current hospital specific data;

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identification of physician and clinician champions; conducting timely death record reviews; establishment of clinical triggers; use of an effective request process; donation team huddles and after-action reviews or follow-up.

Documentation of individualized plan to reach a conversion rate mutually agreed upon between the hospital and OPO to include the following data: authorization rate, conversion rate, timely notification rate, and appropriate requestor rate, obtained by timely medical record reviews. Other data collected should include ME denials, follow-up or after-action review data, and a summary of contact with key hospital leaders and hospital staff members. HD 4.2 Documentation of individualized All hospitals with potential need to have a plan. For those hospitals plan to reach selected hospital's with 20% or less donor potential, a template can be used. The unrealized potential. surveyor should ask for hospital strengths, weaknesses.

HD 4.3 Documentation that the hospital Key personnel must be those with the ability to effect change including development plan has been those identified in the needs assessment. Documentation may be a developed collaboratively with key signature, documentation of meetings or donation council meeting to hospital personnel, and shared with discuss plan for improvement, or any other communication with the identified hospital leadership. hospital that confirms their involvement.

HD 5 DOCUMENTATION OF The OPO will address where this documentation will be kept. As an HOSPITAL DEVELOPMENT example, the documentation may be kept in a computer log. ACTIVITIES The OPO maintains documentation of activities by hospital to include, for example, the following: meetings with key contacts; post donor follow-up and assessment; referral follow-up meetings;

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professional education; hospital rounds; program documentation HD 6 HOSPITAL DEVELOPMENT Training records include documentation of training and competency in STAFF TRAINING areas such as the following: introduction to the HD process (timely The OPO maintains donor potential assessment and data collection procedures, diagnosis documentation of hospital and analysis, planning, implementation and evaluation processes, and development staff orientation, on- the model for improvement); interviewing, selling, marketing skills; going training and evaluation. preceptorship; orientation checklist. Examples of training includes industry best practices such as those identified by HRSA, IHI and the Lewin Group, i.e., first things first and high leverage changes); annual continuing education/training in HD skills. HD 7 STATEMENTS OF AFFILIATION Written statements of affiliation Assess for documentation of written statements of affiliation between shall document the relationship the OPO and at least 90% of the hospitals and other health care between the OPO and at least 90% entities in its service area which have facilities for organ donation. of the hospitals and other healthcare entities in its service area which have facilities for organ donation.

EDUCATION STANDARD ED 1 PUBLIC EDUCATION The OPO shall have an organized approach and/or cooperate with other agencies and organizations to enhance donor awareness. ED 1.1 The OPO shall insure that public The surveyor shall look for evidence that educational programs education programs are directed at the public are conducted. Examples of such programs implemented. could include media programs, classroom education programs, motor vehicle registration programs, civic group programs as well as

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activities centered around National Organ and Tissue Donor Awareness Week.

ED 1.2 The OPO shall have available literature and media vehicles that enable and assist education. ED 1.2.1 The OPO shall be responsible for Surveyor shall look for printed literature and publications which are the dissemination of these directed to the public. Evidence of media vehicles should be materials. documented by written lists of appropriate media contacts as well as media stories carried out during the previous year.

ED 1.3 The OPO shall maintain Evidence of literature dissemination shall be determined by seeking documentation of programs reports of literature distributed during the previous year that shall provided and materials distributed. identify the type of literature as well as the audience. Documentation should be available outlining the public education programs offered during the previous year, attendance and type of audience. ETHICS STANDARD ES 1 CONFLICT OF INTEREST All OPOs shall have policies to properly manage conflicts of interest. ES 1.1 Any OPO employee or board Any OPO employee or board member having a financial interest in the member having a financial interest OPO's transactions must disclose his/her interests and abstain from in the OPO's transactions must voting in matters which directly impact his/her financial situation. disclose, on an annual basis, Assess OPO policy manual for a clear statement on conflict of interest his/her interests and abstain from for both Board members and employees. voting in matters which directly or indirectly impact his/her financial Documentation that service contracts are awarded on the basis of fair situation. bidding. Assess for policy regarding awarding of contracts or ask for examples of how decisions are made.

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Assess relationship of all Board members to OPO, looking specifically for areas in which a Board member may benefit financially from the relationship with the OPO.

Assess written policy that addresses potential conflicts of interest for the OPO’s Executive Director/CEO and COO. ES 1.2 The OPO shall have a policy that The OPO shall have a policy that addresses the direct supervision of addresses the direct supervision of relatives. Determine whether any of the OPO’s management staff or relatives. Board of Directors are related. If employed relative exists, determine existing lines of supervisions. Also assess relative’s qualifications for filling the position in question, and assure no special considerations are given.

ES 2 DONOR REFERRAL FEES There shall be no finder's fees, bounties or commissions paid for the referral of a potential donor. ES 2.1 An organ procurement organization The OPO’s policy for reimbursement will make no reference to referral shall not pay any monies or other fees. Assess a listing of accounts payable for one to two months to form of direct compensation to any determine presence of payment to donor hospital staff members, donor hospital staff member or medical examiner, coroner, etc. If questionable entries are noted, medical examiner/coroner for the request an explanation of services rendered. referral of a potential donor. ES 2.2 In the event specific hospital duty There shall be no finder's fees, bounties or commissions paid for the staff are designated to approach referral of a potential donor, potential donor families, the OPO may and obtain authorization from make arrangements to pay a proportionate share of the designated potential donor families, the OPO individual salary. Assess current compensation methodology for organ may make arrangements to pay a recovery staff and other personnel for the specific function or job duty proportionate share of the performed. designated individual salary. ES 2.2.1 Such payments shall be made

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directly to the hospital and not to the individual. ES 2.3 Fees for services rendered may be transacted between organizations that procure organs, tissues and eyes. ES 3 CONFIDENTIALITY The OPO shall maintain a policy regarding the confidentiality of donor and recipient information. ES 3.1 The OPO shall have a policy for the The OPO shall maintain a policy regarding the confidentiality of donor exchange of information with and recipient information Assess ten donor charts at random to involved parties such as OPOs, determine that recipient confidentiality is maintained in any transplant centers, the OPTN, correspondence to donor family, hospital, etc. AOPO, and CMS, regarding donors and recipients as required for data collection and follow-up. ES 3.2 The OPO shall permit information Assess the OPO’s policy regarding the exchange of information exchange between donor family between donor family members and recipients. Determine method by members and recipients, if mutual which mutual consent for the exchange of information is obtained. consent is obtained. ES 3.3 The OPO shall have a policy Request a policy on dealing with the media. Determine whether or not related to the release of donor, there is a media release form to be signed by the family, donor recipient and/or recovery hospital, transplant hospital, or OPO. organization information to the media. ES 3.4 In compliance with state laws, the OPO shall have a policy and procedure for the documented disclosure of positive laboratory test results, and social and past

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medical history risk factors that present in a donor which might be a public health risk. ES 4 MONETARY COMPENSATION OF DONORS Except as authorized by statute, Except as authorized by statute, monetary compensation or goods or monetary compensation or goods services of value shall not be offered to a donor, a deceased donor's or services of value shall not be next of kin, the donor's estate, or any other third party as an incentive offered to a donor, a deceased to donation. donor's next of kin, the donor's estate, or any other third party as an incentive to donation. ES 4.1 An OPO shall not pay any monies or other form of direct compensation or goods of value to a donor, a deceased donor's next of kin, or any third party to influence the decision to donate. ES 4.2 Direct costs associated with an acceptable donation may be reimbursed to the party providing required service. ES 4.3 Donors or their families should not be responsible for any expense directly related to the recovery of organs. MULTICULTURAL NEEDS STANDARDS MC 1.1 The OPO shall review the linguistic, Look for evidence of percentage/numbers of population by major racial racial, and cultural composition of and language groups, with the UNOS defined races, White, Hispanic, its service area. Asian, African-American as the minimum subsets of racial populations.

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MC 1.2 The OPO shall identify the unique Look for studies of donation/conversion/authorization rates by defined needs for donation in distinct populations populations. MC 1.3 The OPO shall assess the Interview staff and identify staffing or contracted or routinely available availability of staff, services, and services to provide professional-level, primary language volunteers and seek to ensure communications with potential donor families as needed to meet effective primary language defined populations and actual language needs of approached communication and educational potential donor families. Seek evidence of educational activities to support to substantially sized and assist staff in ensuring sensitivity to racial and cultural needs of defined distinct linguistic, racial, and populations and including training in means to overcome common cultural communities, as racially based barriers to donation. determined by the OPO.

MC 1.4 The OPO shall identify and Assess public education material to ensure that it addresses the encourage the distribution of distinct needs of defined populations in order to overcome racially communication tools to expand the based barriers to donation. awareness of donation and the benefit of transplantation among targeted linguistic, racial, and cultural groups throughout the OPO donor service area. MC 1.5 The OPO shall monitor the authorization and conversion rates of distinct linguistic, racial, and cultural groups it has previously identified and sought to serve through specific programming

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CONTINUOUS QUALITY IMPROVEMENT STANDARD QI 1 PLAN

QI 1.1 The OPO must have a planned, - The surveying team shall determine that the Plan: systematic, and organization-wide  is documented (policy or separate document) approach to process design,  defines roles and responsibilities to accomplish the objective performance measurement,  assesses quality assessment and improvement.  focuses on goals to improve outcomes or reduce/prevent errors.  defines the elements outlined in the My OPO Plan*

* Contained in the document, Quality Council Model QI Plan Template.doc. This document is published on the AOPO Quality Council Portal. QI 1.2 Planned - The OPO’s leadership ensures that the quality program reflects the The Continuous Quality OPO’s stated mission and associated services through: Improvement Plan is evaluated and  meeting minutes documented by the leadership of  Board review the OPO at least biennially.  Leadership review  Plan approval and sign-off

- The surveyor should ensure that leadership’s involvement in reviewing the OPO’s Plan is documented. This documentation should contain:  a list of outcome measures  a list of improvement priorities  detail of the quality program’s assessments  the frequency of leadership’s assessment

AOPO encourages an annual review of the Plan. QI 1.3 Systematic - The Plan is based on specific quality indicators that are linked to the

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organization’s goals. Consider observing these goals in the published organization goals, Quality Policy Statements, Improvement Projects, and the Quality Plan.

- The methodology for implementing the Plan is defined (Policy & Procedures, PDSA, Project Management) QI 1.4 Organization-wide - All OPO departments are explicitly referenced in the Quality Plan.

- All OPO departments are involved in the development of the Quality Plan. QI 2 DATA COLLECTION AND ANALYSIS QI 2.1 Data are systematically collected. - The surveyor shall have access to the standard data reports utilized by the OPO. The OPO collects data for both improvement priorities and ongoing - The source of the data is documented. Examples of sources measurement. This data should are AOPO, SRTR, UNOS, and other internal sources. focus on:  Operational volumes - The data describing operational volumes may address  Operational outcomes measurements related to recovered and/or transplanted organs  Areas of risk or potential risk by organ type, frequency of surgical problems/errors encountered, conversion ratios pertaining to potential donors, etc. and/or other indicators that focus on the desired performance and/or problem prone areas for that OPO.

- Consider improvement project reports, data reports, and the Quality Plan to observe organizational choices on the type of data to be collected and the scope of data collection.

- There is a documented method for prioritizing the data. QI 2.2 Data Time Frames - The frequency and detail of the analysis should

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be demonstrated and explained using the A period of time for collection of following components at a minimum: specific data is defined prior to . Statistical methodology review and analysis. . Internal comparison . External comparison . Intensive assessment when there is undesirable variation. QI 2.3 Review - Baseline performance is determined for each quality indicator.

The OPO makes internal - Statistical tools are used to review data. Some examples are run comparisons of its performance of charts, histograms, pareto charts, scatter plots, and control charts. process and outcomes over time. - Any example of a statistical method being utilized should be verified The OPO compares performance with documentation of the methodology’s type and the rationale for its data about its processes and use in each instance. outcomes to external sources.

QI 2.4 Analysis - There is a method used to analyze data.

A systematic process is used to - Special and common causes of variation and trends are identified assess and analyze collected data. in the OPO’s data analysis.

The assessment process uses - The surveyor assesses (review documentation, interview appropriate statistical control personnel) whether the OPO has the ability to: techniques.  analyze its own data  identify opportunities for improvement The OPO initiates intensive  determine corrective action needed assessment when statistical analysis detects undesirable - The organization learns from the analysis by developing an action variation in performance. plan based on the root causes identified.

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QI 3 IMPLEMENTATION QI 3.1 The OPO supports quality program - Specific action plans are documented and used to accomplish the activities that are based on the improvement. Quality Plan, collected data, and  Responsibilities are assigned for improvement activities/tasks. the OPO’s analysis.  Dates (start & finish) are set for these activities/tasks.  Activities/tasks are implemented.  Activities/tasks are reviewed.  Quality targets are set.  Quality targets are reviewed.  Quality targets are achieved. QI 3.2 Leadership - The OPO’s Leadership participates in the planning of the QI processes and the activities/tasks involved.

- The OPO’s Leadership enables action plans to occur.  Provisions are made to have appropriate resources available. QI 3.3 Commitment - Organization-wide commitment is shown through active improvement projects and indicators tracked in each department.  The practice within the OPO matches the established Quality Plan.  Planned QI activities/tasks and associated meeting commitments are kept.  Commitment tasks, dates and quality target are followed.  The OPO has active QI teams.  Interviews with employees demonstrate knowledge of the OPO’s improvement plans and model used. QI 3.4 Training - A training program is used to educate staff on the Quality Plan.  The OPO has documented training records.  Ongoing continuing education on quality is offered to personnel.  Quality learning tools are used.

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QI 4 EVALUATION / CONTINUOUS IMPROVEMENT QI 4.1 The OPO systematically improves - A review of the quality program’s documentation and interviews of its performance. designated quality improvement staff shall demonstrate evidence of how the decisions to select improvement projects are conducted.  Improvement activities are decided by involving all staff, using management exclusively, or using the governing board.  The methodology is documented and supported by Leadership. - The surveyor shall find evidence of performance improvement activities that:  Tracks historic outcomes  Analyzes the opportunity for improvement of these outcomes  Implements changes by developing an action plan  Documentation that the changes are studied, tested, and monitored so feedback is obtained and education regarding the change for improvement is communicated throughout the OPO. QI 4.2 Improvement opportunities are - QI projects use the following methods: prioritized and acted upon  GAP analysis, needs assessments, and audits are used to accordingly. identify if outcomes are reaching desired goals.  Deviations from Standard Operating Procedures and non- conformities are reviewed to identify needed areas of improvement. - The method of prioritizing improvement opportunities is documented. QI 4.3 Effects of improvement actions are - Improvement action plans are reviewed and assessed for positive measured and assessed. improvement. QI 4.4 Effective improvement actions are - The improvement is documented. implemented. - OPO communicates work processes that have been improved in an effort to reapply lessons learned.

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- The OPO has established or modified a policy or procedure based on the outcome of an improvement project. (e.g. PDSA) QI 4.5 When improvement plans are - Unsuccessful QI action plans have been evaluated, revised, or tested and discontinued. found ineffective, they are modified.  An example would be successive cycles of PDSA that indicate an ineffective test or theory that should be revised or discontinued.

TRAINING STANDARD TR 1 ORIENTATION TR 1.1 The OPO must have a formal Look for items such as checklist, preceptor-type programs, and training training program for all employees. seminars. TR1.2 All employees must receive orientation to company and job specific policies and procedures. TR 1.3 There must be documentation of The OPO has documented training records. Ongoing continuing training for all employees. education is offered to personnel TR 1.4 Staff, as well as board members, There should be evidence of corporate compliance training for all new must be trained on corporate employees and Board members within the course of their orientation. compliance and quality upon Additionally, there should be documentation of training for all staff, entering the organization Board and contract employees. Documentation of training can be found in such things as staff meeting minutes, logs, email receipts (acknowledgements), etc. OPOs are encouraged to include corporate compliance language in their hospital agreements. [formerly in AS 11] TR 1.5 Staff must be trained on Blood Borne pathogen exposure within ten days of hire or prior to being placed in an environment of being

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exposed.

TR 1.6 The OPO shall provide training Look to see if users are trained on good security practices, opportunities on OPO software and confidentiality of data, and secure data transmission. Are training technology opportunities provided to staff on software that relate to OPO operations? Ask to see training records and materials. TR 2.0 CORE COMPETENCIES The OPO has structured an ongoing training process centered on core competencies and/or job responsibilities for the job position. TR 2.1 Methodology must be established to determine readiness for responsibilities. TR 2.2 The OPO must assess the training Assess through core competencies for job assignments and critical job needs of each employee. skills. CMS 486.326c TR 2.3 The OPO must show evidence that This may include, but is not limited to, performance expectations as personnel are trained to outlined in CMS 486.326c. receive/respond to referrals and perform clinical responsibilities. TR 2.4 If the OPO recovery personnel Look for items such as checklist, preceptor-type programs, and training utilize portable laboratory devices, seminars. evaluative procedures or preservation machines, evidence of training must exist. TR 2.5 OPO personnel performing hospital Look for items such as use of preceptors, and orientation checklists. development activities must receive training in at least the following areas: HD Process

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Data Collection Planning and Implementation Interviewing Marketing TR 2.6 The OPO provides training Look for training records. instruction regarding handling of blood and/or other bodily fluids/tissues following OSHA standards. TR 3.0 ANNUAL/ONGOING There must be evidence of: TR 3.1 ongoing training for clinical and Request training documentation for approaching families and obtaining staff obtaining authorization. authorization . Review training in medical/social questionnaire. Look for lists of on-going training or evidence of certificates. TR 3.2 Training offered at least annually (CMS 486.322b) Look for lists of on-going training or evidence of for all designated requestors. certificates. TR 3.3 Continuing education in HD skills. Look for lists of on-going training or evidence of certificates.

TR 3.4 Ongoing training opportunities in Look for lists of on-going training or evidence of certificates. quality. TR 3.5 Ongoing training for all staff based Look for lists of on-going training or evidence of certificates. on identified needs or updates for area of work.

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