December, 2011

Basic Control And Prevention Plan for Outpatient Oncology Settings

National Center for Emerging and Zoonotic Infectious Diseases

Division of Healthcare Quality Promotion December, 2011 Preamble Background An estimated 1.5 million new cases of were offices, -based outpatient , diagnosed in the United States in 2010[1]. With im- and nonhospital-based cancer centers. Currently, provements in survivorship and the growth and ag- more than one million cancer patients receive outpa- ing of the U.S. population, the total number of per- tient or each year[6]. sons living with cancer will continue to increase [2]. Acute care continue to specialize in the Despite advances in oncology care, remain treatment of many patients with cancer who are at a major cause of morbidity and mortality among increased risk for infection (e.g., hematopoietic stem cancer patients[3-5]. Increased risks for infection are transplant recipients, patients with febrile neu- attributed, in part, to caused by tropenia), with programs and policies that promote the underlying and chemotherapy. In ad- adherence to infection control standards. In contrast, dition patients with cancer come into frequent con- outpatient oncology facilities vary greatly in their at- tact with healthcare settings and can be exposed to tention to and oversight of infection control and pre- other patients in these settings with transmissible in- vention. This is reflected in a number of outbreaks of fections. Likewise, patients with cancer often require viral hepatitis and bacterial bloodstream infections the placement of indwelling intravascular access de- that resulted from breaches in basic infection preven- vices or undergo surgical procedures that increase tion practices (e.g., syringe reuse, mishandling of in- their risk for infectious complications. Given their travenous administration sets)[7-10]. In some of these vulnerable condition, great attention to infection incidents, the implicated facility did not have written prevention is warranted in the care of these patients. infection control policies and procedures for patient In recent decades, the vast majority of oncology protection or regular access to infection prevention services have shifted to outpatient settings, such as expertise.

Scope A. Intent and Implementation and interact regularly with staff. Facilities may wish to This document has been developed for outpatient on- consult with an individual with training and expertise in cology facilities to serve as a model for a basic infec- infection prevention early on to assist with their infec- tion control and prevention plan. It contains policies tion control plan development and implementation and and procedures tailored to these settings to meet min- to ensure that facility design and work flow is conducive imal expectations of patient protections as described to optimal infection prevention practices. in the CDC Guide to Infection Prevention in Outpatient Settings (available: http://www.cdc.gov/HAI/settings/ B. Aspects of Care That Are Beyond the Scope of outpatient/outpatient-care-guidelines.html). The ele- This Plan ments in this document are based on CDC’s evidence- This model plan focuses on the core measures to pre- based guidelines and guidelines from professional so- vent the spread of infectious diseases in outpatient on- cieties (e.g., Oncology Society). cology settings. It is not intended to address facility- This plan is intended to be used by all outpatient specific issues or other aspects of patient care such as: oncology facilities. Those facilities that do not have an • Infection prevention issues that are unique to blood existing plan should use this plan as a starting point to and marrow transplant centers (a.k.a. bone marrow develop a facility-specific plan that will be updated and transplant or stem cell transplant centers) further supplemented as needed based on the types of • Occupational health requirements, including recom- services provided. Facilities that have a plan should en- mended personal protective equipment for handling sure that their current infection prevention policies and antineoplastic and hazardous drugs as outlined by procedures include the elements outlined in this docu- the Occupational Safety and Health Administration ment. While this plan may essentially be used exactly and the National Institute for Occupational Safety “as is,” facilities are encouraged to personalize the plan • Appropriate preparation and handling (e.g., recon- to make it more relevant to their setting (e.g., adding stituting, mixing, diluting, compounding) of sterile facility name and names of specific rooms/locations; medications, including antineoplastic agents inserting titles/positions of designated personnel; and • Clinical recommendations and guidance on appro- providing detailed instructions where applicable). priate antimicrobial prescribing practices and the This plan does not replace the need for an outpatient assessment of risk in patients undergo- oncology facility to have regular access to an individual ing chemotherapy with training in infection prevention and for that individ- For more information on these topics, refer to the ual to perform on-site evaluation and to directly observe list of resources provided in Appendix D of the plan. December, 2011

References Infection Prevention Plan 1 . Can- cer Facts & Figures 2010 Tables & Figures. http://www.cancer.org/Re- search/CancerFactsFigures/Cancer- FactsFigures/most-requested-tables- Table of Contents figures-2010. 2 Warren JL, Mariotto AB, Meekins List of Abbreviations ...... 2 A, Topor M, Brown ML. Current and future utilization of services from medical oncologists. J Clin Oncol I . Fundamental Principles of 2008;26:3242−7. Infection Prevention ...... 2 3 Kamboj M, Sepkowitz KA. Nosocomi- A. Standard Precautions ...... 2 al infections in patients with cancer. Lancet Oncol 2009;10:589−97. B. Transmission-Based Precautions ...... 2 4 Maschmeyer G, Haas A. The epide- miology and treatment of infections II . Education and Training ...... 2 in cancer patients. Int J Antimicrob Agents 2008;31:193−7. III . Surveillance and Reporting ...... 3 5 Guinan JL, McGuckin M, Nowell PC. Management of health-care−as- sociated infections in the oncology IV . Standard Precautions ...... 3 patient. 2003;17:415−20. Oncology A. Hand Hygiene 3 6 Halpern MT, Yabroff KR. Prevalence B. Personal Protective Equipment 4 of outpatient cancer treatment in the United States: estimates from C. Respiratory Hygiene and Cough Etiquette ...... 5 the Medical Panel Expenditures D. Injection Safety ...... 6 Survey (MEPS). Cancer Invest 2008;26:647−51. E. Medication Storage and Handling ...... 7

7 Macedo de Oliveria A, White KL, F. Cleaning and Disinfection of Devices Leschinsky DP, Beecham BD, Vogt and Environmental Surfaces 8 TM, Moolenaar RL et al. An out- break of hepatitis C virus infections among outpatients at a hematol- V . Transmission-Based Precautions . . . . . 11 ogy/oncology . Ann Intern Med A. Identifying Potentially Infectious Patients ...... 11 2005;142:898−902. B. Contact Precautions ...... 11 8 Watson JT, Jones RC, Siston AM, C. Droplet Precautions ...... 11 Fernandez JR, Martin K, Beck E, et al. Outbreak of catheter-associated D. Airborne Precautions 12 Klebsiella oxytoca and Enterobacter cloacae bloodstream infections in an oncology chemotherapy center. Arch VI . Central Venous Catheters ...... 12 Intern Med 2005;165:2639−43. A. General Maintenance and Access Procedures 12 9 Greeley RD, Semple S, Thompson ND, B. Peripherally Inserted Central Catheters (PICCs) ...... 13 High P, Rudowski E, Handschur E et al. Hepatitis B outbreak associated C. Tunneled Catheters 14 with a -oncology office D. Implanted Ports ...... 14 practice in New Jersey, 2009. Am J Infect Control 2011 Jun 8. Epub ahead of print. Appendices ...... 15 A. Example List of Contact Persons 10 Herndon E. Rose Cancer Center shut and Roles/Responsibilities 15 down; patients advised to get screen- ing. Enterprise-Journal. July 31, 2011. B. Reportable Diseases/Conditions ...... 16 Available at: http://www.enterprise- C. CDC Infection Prevention Checklist for journal.com/news/article_58190090- Outpatient Settings 17 bbb5-11e0-b99d-001cc4c03286.html Accessed September 9, 2011. D. Additional Resources 28 December, 2011

List of Abbreviations HIV Human immunodeficiency virus ANC Absolute neutrophil count IDSA Infectious Diseases Society of America APIC Association for Professionals in Infection INS Infusion Nursing Society Control and Epidemiology, Inc . ONS Oncology Nursing Society CDC Centers for Disease Control and OSHA Occupational Safety and Health Prevention Administration DEA Drug Enforcement Administration NIOSH National Institute for Occupational Safety EPA Environmental Protection Agency PPE Personal protective equipment FDA Food and Drug Administration SHEA Society for Healthcare Epidemiology of HAI Healthcare-associated infection America HBV Hepatitis B virus USP United States Pharmacopeia HCV Hepatitis C virus WHO World Health Organization

I . Fundamental Principles of Infection Prevention

Standard Precautions Precautions, 2) Droplet Precautions, and 3) Airborne Standard Precautions represent the minimum infec- Precautions. For diseases that have multiple routes of tion prevention measures that apply to all patient care, transmission, a combination of Transmission-Based regardless of suspected or confirmed infection status Precautions may be used. Whether used singly or in of the patient, in any setting where healthcare is de- combination, they are always used in addition to Stan- livered. These evidence-based practices are designed dard Precautions. to both protect healthcare personnel and prevent the The risk of infection transmission and the ability to im- spread of infections among patients. Standard Precau- plement elements of Transmission-Based Precautions tions replaces earlier guidance relating to Universal may differ between outpatient and inpatient settings Precautions and Body Substance Isolation. Standard (e.g., facility design characteristics). However, because Precautions include: 1) hand hygiene, 2) use of personal patients with infections are routinely encountered in protective equipment (e.g., gloves, gowns, facemasks), outpatient settings, facilities need to depending on the anticipated exposure, 3) respiratory develop specific strategies to control the spread of hygiene and cough etiquette, 4) safe injection prac- transmissible diseases pertinent to their setting. This in- tices, and 5) safe handling of potentially contaminated cludes developing and implementing systems for early equipment or surfaces in the patient environment. detection and management of potentially infectious patients at initial points of entry to the facility. Transmission-Based Precautions For detailed information on Standard and Transmis- Transmission-Based Precautions are intended to sion-Based Precautions, and summary guidance for supplement Standard Precautions in patients with outpatient settings, refer to the following documents: known or suspected colonization or infection of highly CDC Guide to Infection Prevention in Outpatient Settings transmissible or epidemiologically important patho- (available at: http://www.cdc.gov/HAI/settings/outpatient/ gens. These additional precautions are used when the outpatient-care-guidelines.html) route of transmission is not completely interrupted using Standard Precautions. The three categories of CDC 2007 Guideline for Isolation Precautions (available at: Transmission-Based Precautions include: 1) Contact http://www.cdc.gov/hicpac/pdf/isolation/Isolation2007.pdf)

II . Education and Training

Ongoing education and training of facility staff 1. Education and Training are required to maintain competency and ensure • All facility staff, including contract personnel (e.g., that infection prevention policies and procedures environmental services workers from an outside are understood and followed. A list of names of agency) are educated and trained by designated designated personnel and their specific roles and personnel regarding: tasks and contact information is provided in Ap- • Proper selection and use of PPE pendix A. • Job- or task-specific infection prevention practices 2 December, 2011

• Personnel providing training have demonstrated 2. Competency Evaluations and maintained competency related to the spe- • Competency of facility staff is documented initially and cific jobs or tasks for which they are providing in- repeatedly, as appropriate for the specific job or task struction • Regular audits of facility staff adherence to infec- • Training is provided at orientation, repeated at least tion prevention practices (e.g., hand hygiene, envi- annually and anytime polices or procedures are up- ronmental cleaning) are performed by designated dated, and is documented as per facility policy personnel

III . Surveillance and Reporting

Routine performance of surveillance activities is im- • Designated personnel collect, manage, and analyze portant to case-finding, outbreak detection, and- im relevant data provement of healthcare practices. This includes the • Surveillance reports are prepared and distributed surveillance of infections associated with the care pro- periodically to appropriate personnel for any neces- vided by the facility (defined as healthcare-associated sary follow-up actions (e.g., high incidence of certain infections) and process measures related to infection HAIs may prompt auditing of specific procedures or prevention practices (e.g., hand hygiene). a thorough infection control assessment)

1. HAI Surveillance 2. Disease Reporting • Standard definitions are developed for specific • Facility staff adhere to local, state and federal re- HAIs under surveillance (e.g., central-line associated quirements for reportable diseases and outbreak re- bloodstream infections) porting [see Appendix B].

IV . Standard Precautions

A. Hand Hygiene

Hand hygiene procedures include the use of alco- • Rinse hands with water and dry thoroughly with hol-based hand rubs (containing 60-95% ) paper towel and handwashing with soap and water. Alcohol- • Use paper towel to turn off water faucet based hand rub is the preferred method for decon- taminating hands, except when hands are visibly 2. Indications for Hand Hygiene soiled (e.g., dirt, blood, body fluids), or after car- Always perform hand hygiene in the following situations: ing for patients with known or suspected infectious • Before touching a patient, even if gloves will be diarrhea (e.g., Clostridium difficile, norovirus), in worn which case soap and water should be used. Hand • Before exiting the patient’s care area after touch- hygiene stations should be strategically placed to ing the patient or the patient’s immediate envi- ensure easy access. ronment • After contact with blood, body fluids or excretions, 1. Sample Procedures for Performing Hand Hygiene or wound dressings • Prior to performing an aseptic task (e.g., accessing a Using Alcohol-based Hand Rub , preparing an injection) (follow manufacturer’s directions): • If hands will be moving from a contaminated-body • Dispense the recommended volume of product site to a clean-body site during patient care • Apply product to the palm of one hand • After glove removal • Rub hands together, covering all surfaces of hands and fingers until they are dry (no rinsing is required) CDC Guideline for Hand Hygiene in Health-Care Settings (available at: http://wwwdev.cdc.gov/mmwr/PDF/rr/ Handwashing with Soap and Water: rr5116.pdf) • Wet hands first with water (avoid using hot water) • Apply soap to hands WHO Guidelines on Hand Hygiene in Healthcare • Rub hands vigorously for at least 15 seconds, cov- 2009 (available at: http://whqlibdoc.who.int/publica- ering all surfaces of hands and fingers tions/2009/9789241597906_eng.pdf) 3 December, 2011 B. Personal Protective Equipment

Personal Protective Equipment (PPE) use involves sidered adequate eye protection specialized clothing or equipment worn by facility • May use goggles with facemasks, or face shield staff for protection against infectious materials. The alone, to protect the mouth, nose and eyes selection of PPE is based on the nature of the patient interaction and potential for exposure to blood, body Respirators fluids or infectious agents. A review of available PPE If available, wear N95-or higher respirators for poten- should be performed periodically (e.g., annually) due tial exposure to infectious agents transmitted via the to new product developments and improvements. airborne route (e.g., tuberculosis). Please note that this section does not address issues • All healthcare personnel that use N95-or higher res- related to PPE for the preparation and handling of an- pirator are fit tested at least annually and according tineoplastic and hazardous drugs. The recommended to OSHA requirements PPE for those procedures should be determined in ac- cordance with OSHA and NIOSH. 2. Recommendations for Donning PPE • Always perform hand hygiene before donning PPE 1. Use of PPE • If wearing a gown, don the gown first and fasten in back accordingly Gloves • If wearing a facemask or respirator: Wear gloves when there is potential contact with • Secure ties or elastic band at the back of the head blood (e.g., during phlebotomy), body fluids, mucous and/or neck membranes, nonintact skin or contaminated equip- • Fit flexible band to nose bridge ment. • Fit snug to face and below chin • Wear gloves that fit appropriately (select gloves ac- • If wearing goggles or face shield, put it on face and cording to hand size) adjust to fit • Do not wear the same pair of gloves for the care of • If wearing gloves in combination with other PPE, more than one patient don gloves last • Do not wash gloves for the purpose of reuse • Perform hand hygiene before and immediately after 3. Recommendations for Removing PPE removing gloves • Remove PPE before leaving the exam room or pa- tient environment (except respirators which should Gowns be removed after exiting the room) Wear a gown to protect skin and clothing during • Removal of gloves: procedures or activities where contact with blood or • Grasp outside of glove with opposite gloved hand; body fluids is anticipated. peel off • Do not wear the same gown for the care of more • Hold removed glove in glove hand than one patient • Slide ungloved fingers under the remaining glove • Remove gown and perform hand hygiene before at the wrist; peel off and discard leaving the patient’s environment (e.g., exam room) • Removal of gowns: • Remove in such a way to prevent contamination of Facemasks (Procedure or Surgical Masks) clothing or skin Wear a facemask: • Turn contaminated outside surface toward the in- • When there is potential contact with respiratory se- side cretions and sprays of blood or body fluids (as de- • Roll or fold into a bundle and discard fined in Standard Precautions and/or Droplet- Pre • Removal of facemask or respirator cautions) • Avoid touching the front of the mask or respirator • May be used in combination with goggles or face • Grasp the bottom and the ties/elastic to remove shield to protect the mouth, nose and eyes and discard • When placing a catheter or injecting material into • Removal of goggles or face shield the spinal canal or subdural space (to protect pa- • Avoid touching the front of the goggles or face shield tients from exposure to infectious agents carried in • Remove by handling the head band or ear pieces the mouth or nose of healthcare personnel) and discard • Wear a facemask to perform intrathecal chemo- • Always perform hand hygiene immediately after re- therapy moving PPE

CDC 2007 Guideline for Isolation Precautions (available at: Goggles, Face Shields http://www.cdc.gov/hicpac/pdf/isolation/Isolation2007.pdf) Wear eye protection for potential splash or spray of blood, respiratory secretions, or other body fluids. CDC’s tools for personal protective equipment (available: • Personal eyeglasses and contact lenses are not con- http://www.cdc.gov/HAI/prevent/ppe.html) 4 December, 2011 C. Respiratory Hygiene and Cough Etiquette

To prevent the transmission of respiratory infec- If identified after arrival: tions in the facility, the following infection preven- • Provide facemasks to all persons (including per- tion measures are implemented for all potentially sons accompanying patients) who are coughing infected persons at the point of entry and continuing and have symptoms of a respiratory infection throughout the duration of the visit. This applies to • Place the coughing patient in an exam room with any person (e.g., patients and accompanying family a closed door as soon as possible (if suspicious members, caregivers, and visitors) with signs and for airborne transmission, refer to Airborne Pre- symptoms of respiratory illness, including cough, cautions in Section V.D.); if an exam room is not congestion, rhinorrhea, or increased production of available, the patient should sit as far from other respiratory secretions. Additional precautions (e.g., patients as possible in the waiting room Transmission-Based Precautions) can be found in • Accompanying persons who have symptoms of a Section V. respiratory infection should not enter patient-care areas and are encouraged to wait outside the facility 1. Identifying Persons with Potential Respiratory Infection 5. Healthcare Personnel Responsibilities • Facility staff remain alert for any persons arriving • Healthcare personnel observe Droplet Precautions with symptoms of a respiratory infection (refer to Section V.C.), in addition to Standard Pre- • Signs are posted at the reception area instructing cautions, when examining and caring for patients patients and accompanying persons to: with signs and symptoms of a respiratory infection • Self-report symptoms of a respiratory infection (if suspicious for an infectious agent spread by air- during registration borne route, refer to Airborne Precautions in Sec- • Practice respiratory hygiene and cough etiquette tion V.D.) (technique described below) and wear facemask • These precautions are maintained until it is deter- as needed mined that the cause of the symptoms is not an infectious agent that requires Droplet or Airborne 2. Availability of Supplies Precautions The following supplies are provided in the reception • All healthcare personnel are aware of facility sick area and other common waiting areas: leave policies, including staff who are not directly • Facemasks, tissues, and no-touch waste receptacles employed by the facility but provide essential daily for disposing of used tissues services • Dispensers of alcohol-based hand rub • Healthcare personnel with a respiratory infection avoid direct patient contact; if this is not possible, 3. Respiratory Hygiene and Cough Etiquette then a facemask should be worn while providing All persons with signs and symptoms of a respiratory patient care and frequent hand hygiene should be infection (including facility staff) are instructed to: reinforced • Cover the mouth and nose with a tissue when • Healthcare personnel are up-to-date with all recom- coughing or sneezing; mended vaccinations, including annual influenza • Dispose of the used tissue in the nearest waste re- vaccine ceptacle • Perform hand hygiene after contact with respiratory 6. Staff Communication secretions and contaminated objects/materials • Designated personnel regularly review information on local respiratory virus activity provided by the 4. Masking and Separation of Persons with health department and CDC to determine if the fa- Respiratory Symptoms cility will need to implement enhanced for If patient calls ahead: respiratory symptoms as outlined in step 7 • Have patients with symptoms of a respiratory infec- tion come at a time when the facility is less crowd- 7. During Periods of Increased Community ed or through a separate entrance, if available Respiratory Virus Activity (e.g., Influenza Season) • If the purpose of the visit is non-urgent, patients In addition to the aforementioned infection prevention are encouraged to reschedule the appointment measures, the following enhanced screening measures until symptoms have resolved are implemented: • Upon entry to the facility, patients are to be in- • When scheduling and/or confirming appointments: structed to don a facemask (e.g., procedure or sur- • Pre-screen all patients and schedule those with gical mask) respiratory symptoms to come when the facility • Alert registration staff ahead of time to place the might be less crowded, if possible patient in an exam room with a closed door upon • Instruct patients with respiratory symptoms to arrival don a facemask upon entry to the facility 5 December, 2011

• If the purpose of the visit is non-urgent, patients i. A separate triage station is established to iden- with symptoms of respiratory infection are encour- tify pre-screened patients (from the list) and aged to schedule an appointment after symptoms to screen all other patients and accompany- have resolved ing persons immediately upon their arrival and • Encourage family members, caregivers, and visitors prior to registration with symptoms of respiratory infection to not ac- ii. Patients identified with respiratory symptoms company patients during their visits to the facility are registered in a separate area, if possible, • If possible, prepare in advance for the registra- and placed immediately in a private exam tion staff a daily list of patients with respiratory room; if an exam room is not available, patients symptoms who are scheduled for a visit are provided a facemask and placed in a sepa- • Upon entry to the facility and during visit: rate area as far as possible from other patients • At the time of patient registration, facility staff while awaiting care identify pre-screened patients (from the list) and • If possible, encourage family members, caregiv- screen all other patients and accompanying per- ers, and visitors with symptoms of respiratory sons for symptoms of respiratory infection infection to not enter the facility • Patients identified with respiratory symptoms CDC 2007 Guideline for Isolation Precautions (available at: are placed in a private exam room as soon as http://www.cdc.gov/hicpac/pdf/isolation/Isolation2007.pdf) possible; if an exam room is not available, pa- tients are provided a facemask and placed in a CDC recommendations for preventing the spread of influen- separate area as far as possible from other pa- za in healthcare settings (available at: http://www.cdc.gov/ flu/professionals/infectioncontrol/healthcaresettings.htm ) tients while awaiting care • If patient volume is anticipated to be higher than CDC’s Flu Activity & Surveillance (available at: www.cdc. usual with prolonged wait time at registration: gov/flu/weekly/fluactivitysurv.htm)

D. Injection Safety

Injection safety refers to the proper use and handling except in accordance with standards of supplies for administering injections and infusions • Avoid unwrapping syringes prior to the time of use (e.g., syringes, needles, fingerstick devices, intrave- • Never administer medications from the same syringe nous tubing, medication vials, and parenteral solu- to multiple patients, even if the needle is changed or tions). These practices are intended to prevent trans- the injection is administered through an intervening mission of infectious diseases between one patient length of intravenous tubing and another, or between a patient and healthcare per- • Do not reuse a syringe to enter a medication vial or sonnel during preparation and administration of par- solution enteral medications. • Do not administer medications from single-dose or To the extent possible, medication preparation single-use vials, ampoules, or bags or bottles of in- should take place in pharmacy settings and dedicated travenous solution to more than one patient (e.g, do medication rooms. All staff personnel who use or han- not use a bag of saline as a common source supply dle parenteral medications and related supplies should for multiple patients) be aware of labeling and storage requirements and • Cleanse the access diaphragms of medication vials pharmacy standards. Additional recommendations with 70% alcohol and allow the alcohol to dry before for safe injection practices, including the appropriate inserting a device into the vial use of single-dose (or single-use) and multi-dose vi- • Dedicate multi-dose vials to a single patient when- als and the proper technique for accessing intravascu- ever possible. If multi-dose vials must be used for lar devices, can be found in Section IV.E. (Medication more than one patient, they are restricted to a dedi- Storage and Handling), in Section VI (Central Venous cated medication preparation area and should not Catheters), respectively, as well as in Appendix D. enter the immediate patient treatment area (e.g., exam room, chemotherapy suite) 1. General Safe Injection Practices • Dispose of used syringes and needles at the point of • Use aseptic technique when preparing and admin- use in a sharps container that is closable, puncture- istering chemotherapy infusions or other parenteral resistant, and leak-proof medications (e.g., antiemetics, diphenhydramine, • Do not use fluid infusion or administration sets (e.g., dexamethasone) intravenous tubing) for more than one patient • Whenever possible, use commercially manufactured • Use single-use, disposable fingerstick devices (e.g., or pharmacy-prepared prefilled syringes (e.g., saline lancets) to obtain samples for checking a patient’s and heparin) blood glucose, PT/INR, etc. and dispose of them af- • Avoid prefilling and storing batch-prepared syringes ter each use; do not use a lancet holder or penlet 6 December, 2011

device for this purpose mon trays of supplies for phlebotomy or intravenous • Adhere to federal and state requirements for pro- device access to the patient’s immediate treatment tection of healthcare personnel from exposure to area; bring only the necessary supplies to the pa- bloodborne pathogens tient side • Hand hygiene stations (e.g., alcohol-based hand rub 2. Spinal Injection Procedures dispensers) are readily accessible to the phleboto- • Use aseptic technique and follow safe injection mist practices (e.g., dedicating single-dose vials to sin- • Use aseptic technique to perform the phlebotomy gle-patient use) procedure • At a minimum, wear a facemask (e.g., procedure or • Do not reuse vacutainer holders surgical masks) and sterile gloves when injecting • Sharps containers are strategically placed near the material or inserting a catheter into the epidural or phlebotomist to ensure easy access and safe dis- subdural space (e.g., administration of intrathecal posal of used supplies chemotherapy) • Minimize environmental contamination by perform- • For other spinal procedures (e.g., diagnostic and ing the following: therapeutic lumbar punctures) or handling of devic- • Label tubes before blood is drawn es to access the cerebrospinal fluid (e.g., Ommaya • Avoid placing tubes on patient charts or oth- reservoir): er items or surfaces that cannot be properly • At a minimum, use aseptic technique and follow cleaned safe injection practices • Do not process or store blood specimens near • Facemask can be considered as an additional medications or medication preparation area precaution CDC 2007 Guideline for Isolation Precautions (available at: http://www.cdc.gov/hicpac/pdf/isolation/Isolation2007.pdf) 3. Phlebotomy Procedures • Phlebotomy procedures are performed in a dedi- CDC Clinical Reminder: Spinal Injection Procedures Per- cated area, if possible formed without a Facemaks Pose Risk for Baterial Menin- • If the procedure has to be done elsewhere (e.g., gitis (available at: http://www.cdc.gov/injectionsafety/PDF/ exam room, chemotherapy suite), do not bring com- Clinical_Reminder_Spinal-Infection_Meningitis.pdf)

E. Medication Storage and Handling

The measures outlined in this section pertain to the Single-dose vials (or single-use vials) are intended for general storage and handling of parenteral medica- use in a single patient for a single case/procedure/in- tions outside of the pharmacy setting. The appro- jection. Single-dose or single-use vials are labeled as priate storage and handling (e.g., reconstituting, such by the manufacturer and typically lack an antimi- mixing, diluting, compounding) of antineoplastic crobial preservative. drugs and other sterile medications that typically require preparation in pharmacy settings should be Multi-dose vials contain more than one dose of medi- determined in accordance with established official cation. They are labeled as such by the manufacturer and enforceable standards for these activities (e.g., and typically contain an antimicrobial preservative to ensuring appropriate environmental and engineer- help prevent the growth of . However, this pre- ing controls such as biological safety cabinets and servative has no effect on viruses and does not fully laminar airflow hoods, and proper use of aseptic protect against contamination when safe injection technique), including those of the United States practices are not followed. Pharmacopeia and the Food and Drug Administra- tion. These functions are performed by personnel 1. Medication Storage who have the appropriate qualifications and train- • Store all medications (e.g., injectable hormonal ing as determined in accordance with the state agents) in accordance with manufacturer’s instruc- pharmacy board. Consultation with the state phar- tions (e.g., shelf-life, temperature) macy board and oncology pharmacy specialists is • Use of freezers/refrigerators recommended. • Store medications that require refrigeration in In general, parenteral medication storage, handling, a dedicated, labeled refrigerator that meets re- and administration should adhere to injection safety quirements for such storage (e.g., thermostat measures as outlined in Section IV.D. (Injection Safe- control, separate exterior door for refrigerator ty). Parenteral medications include single-dose and and freezer compartments) multi-dose vials, ampoules, bags or bottles of intrave- • Designated personnel maintain temperature log nous fluids. (monitor temperature at least twice daily for 7 December, 2011

vaccine storage) and ensure alternative storage tum (e.g., chemotherapy dispensing pins) are method is in place in the event of power or re- used in accordance with manufacturer’s in- frigerator failure structions and they do not compromise the • Multi-dose vials are stored in the Medication Room integrity of the remaining vial contents and not in the immediate patient treatment area • Minimize multiple entries into bags of fluid to add (e.g., exam room, chemotherapy suite) medications; if more than one entry is required, always use a new sterile syringe and sterile nee- 2. Medication Preparation dle and access the bag using aseptic technique • Draw up medications in the Medication Room or in a designated clean area that is free of any items 3. When to Discard Medications potentially contaminated with blood or body fluids • Medications should always be discarded accord- (e.g., used equipment such as syringes, needles, IV ing to the manufacture’s expiration date (even if not tubing, blood collection tubes, and needle holders) opened) and whenever sterility is compromised or • Note: Multi-dose vials should not be accessed in the questionable immediate patient treatment area (e.g., exam room, • For single-dose vials that have been opened or ac- chemotherapy suite); if a multi-dose vial enters the cessed (e.g., needle-puncture), the vial should be immediate patient-care area, it should be dedicated discarded according to the time the manufacturer to that patient and discarded after use specifies for the opened vial or at the end of the • Note: Bags or bottles of intravenous solution (e.g., case/procedure for which it is being used, whichever bag of saline) should not be used for more than one comes first. It shouldnot be stored for future use. patient • For multidose vials that have been opened or ac- • Use an aseptic technique to access parenteral medi- cessed (e.g., needle-punctured), the vials should cations: be dated and discarded within 28 days unless the • Perform hand hygiene before handling the manufacturer specifies a different (shorter or- lon medication ger) date for that opened vial • Disinfect the rubber septum with alcohol and allow the alcohol to dry prior to piercing CDC 2007 Guideline for Isolation Precautions (available at: • Always use a new sterile syringe and sterile http://www.cdc.gov/hicpac/pdf/isolation/Isolation2007.pdf) needle to draw up the medication; be careful CDC FAQs Regarding Safe Practices for Medical Injections to avoid contact with the non-sterile environ- (available at: http://www.cdc.gov/injectionsafety/providers/ ment during the process provider_faqs.html) • Never leave a needle inserted into the septum of a medication vial for multiple draws CDC Vaccine Storage and Handling Toolkit (available at: • Ensure that any device inserted into the sep- http://www2a.cdc.gov/vaccines/ed/shtoolkit/)

F. Cleaning and Disinfection of Devices and Environmental Surfaces

The procedures outlined in this section pertain to the cific responsibilities for cleaning and disinfection cleaning and disinfection of noncritical patient-care during clinic hours devices (e.g., blood pressure cuff) and environmental • All assigned personnel are trained in the appropri- surfaces in patient-care areas (e.g., exam rooms) and ate cleaning/disinfection procedures and the proper certain common-use areas (e.g., bathrooms). use of PPE and cleaning products Standard procedures and recommended practices for cleaning and disinfecting compounding areas (e.g., 2. Supplies and Cleaning Products pharmacy settings) and the handling, transporting, and • Designated personnel regularly restock necessary disposing of antineoplastic agents should be determined supplies (e.g., gloves, gowns, facemasks) and re- in accordance with local, state, and federal authorities, plenish dispensers of alcohol-based hand rub and including state board of pharmacy, USP, FDA, and DEA. soap throughout the facility • Follow manufacturer’s instructions for cleaning sur- 1. Designated Personnel faces and noncritical devices; ensure that the clean- • Responsibilities for cleaning and disinfection of en- ing product used is compatible with the surface/ vironmental surfaces and medical equipment are device being cleaned assigned to specific personnel (as indicated in Ap- • Use EPA-registered disinfectant with appropriate pendix B) germicidal claim for the infective agent of concern • If Environmental Services are only available after- (may vary depending on situation) and follow the hours (e.g., contractors from outside agency), manufacturer’s safety precautions and instructions then designated facility staff are assigned spe- (e.g., amount, dilution, safe use, storage and dispos- 8 December, 2011

al) for cleaning/disinfection • Follow manufacturer’s instructions for cleaning and • Products and supplies are reviewed periodically maintaining noncritical medical device/equipment (e.g., annually) due to product developments and • Clean walls, blinds, and window curtains when they improvements and to ensure that the materials used are visibly dusty or soiled are consistent with existing guidelines and meet the needs of the staff Cleaning and disinfection measures for specific pa- • If reusable mops and cleaning cloths are used, these tient-care areas: are cleaned after use and allowed to dry before reuse Exam Rooms 3. Frequency of Cleaning • Change the paper covering the exam table and pil- Patient-care areas, medication preparation areas (out- lows between patient use side pharmacy/compounding areas), and bathrooms • Place any used linens (e.g., exam gowns, sheets) in a are cleaned at least daily, with the following exceptions: designated container located in each exam room af- • Promptly clean and decontaminate any location ter each patient use; refer to step 8 below for laun- with spills of blood and other potentially infectious dering soiled linens materials (refer to step 7 below) • Clean any medication preparation area after each • Clean medication preparation areas when visibly patient encounter and ensure contaminated items soiled; if medication preparation takes place in the (as described above) are not placed in or near the patient treatment area (outside a designated medi- area cation room), clean this area after each patient en- • Focus cleaning on high-touch surfaces (at least counter: daily), e.g., exam bed, bedrails, blood pressure cuff, • Ensure the medication preparation area is free stethoscope, wall-mounted ophthalmoscope and of any items contaminated with blood or body otoscope (per manufacturer’s instructions), chair fluids (e.g., used equipment such as syringes, and bedside stool, and door knob needles, IV tubing, blood collection tubes, and • Decontaminate high-touch surfaces using an EPA- needle holders) registered disinfectant with specific claim labels for • Disinfect bathrooms after use by a patient with the infective agent known or suspected infectious diarrhea and before • If patient has suspected infectious diarrhea and use by another person (refer to step 5 below) the infective agent is unknown, clean high-touch • Disinfect environmental surfaces and noncritical pa- surfaces using a sodium hypochlorite (bleach)- tient-care devices when visibly soiled based product (e.g., 1:10 dilution prepared fresh) • Disinfect environmental surfaces and noncritical pa- tient-care devices in between patient use if: Chemotherapy Suites • There was direct contact to non-intact skin or • Clean patient chair, IV poles/pumps, and side table mucous membrane or potential contamination between each patient use with body fluids (e.g., blood, secretions) • Clean any medication preparation area after each pa- • The patient-care device involves a blood glucose tient encounter and ensure contaminated items (as meter or other point of care testing device (e.g., described above) are not placed in or near the area PT/INR readers) that utilizes blood samples; to prevent bloodborne pathogen transmission, Triage Stations and/or Locations for Performing these devices must be cleaned and disinfected Vital Signs (if not done in exam rooms) after each use in accordance with manufactur- • Focus cleaning on high-touch surfaces (at least dai- er’s instructions ly): patient chair, blood pressure cuff, pulse oximetry sensors (follow manufacturer’s instructions), ther- 4. Cleaning Patient-Care Areas mometers (if disposable oral temperature probes General cleaning and disinfection measures that apply are used, they should be discarded after each use) to any patient-care area: • Wear appropriate PPE Phlebotomy Stations • In general, cleaning should be performed before dis- • Focus cleaning on high-touch surfaces (at least dai- infection unless a one-step detergent disinfectant is ly): patient chair and arm rest, procedure table used • Promptly clean and disinfect surfaces contaminated • Wet-dust horizontal surfaces by moistening a cloth by blood using an EPA-registered disinfectant with with a small amount of an EPA-registered disinfectant specific label claims for bloodborne pathogens (e.g, • Avoid dusting methods that disperse dust (e.g., HIV, HBV, HCV); refer to step 7 for cleaning spills of feather-dusting) blood • Concentrate on cleaning high-touch surfaces (areas frequently touched by patients and facility staff) 5. Cleaning Bathrooms and those in close proximity to the patient, as out- • Wear appropriate PPE lined below for specific rooms/areas • Clean the toilet, the area around the toilet, the sink, 9 December, 2011

and faucet handles at least daily, and the walls if vis- chute; do not place loose items in the laundry chute ibly soiled • In the laundry area, appropriate PPE (e.g., gloves) • If used by a patient with known or suspected infec- are worn by laundry personnel while sorting soiled tious diarrhea, clean the bathroom before it is used linen, and hand hygiene supplies are available for again, focusing on the toilet and the area around the their use toilet: • If laundry equipment is available on premise, use • Use an EPA-registered disinfectant with specific and maintain the equipment according to manufac- claim labels for the infective agent turer’s instructions • If infective agent is unknown, use a bleach-based • In general, If hot-water laundry cycles are used, disinfectant (e.g., 1:10 dilution prepared fresh) wash with detergent in water ≥160°F (≥71°C) for ≥25 minutes 6. Cleaning Medication Rooms (excluding pharmacy • If low-temperature (<160°F [<70°C]) laundry cy- settings or locations where sterile compounding is cles are used, wash with proper concentrations performed; for these locations, refer to the state of laundry chemicals that are suitable for low- pharmacy board and USP recommendations) temperature washing • Wear appropriate PPE • If commercial laundry facilities are used, ensure that • Clean the countertops and surfaces where medica- their laundering process is in accordance with cur- tion preparation occurs at least daily and when vis- rent recommendations ibly soiled • Ensure contaminated items (as described above) 9. Waste Disposal are not placed in or near the medication prepara- • Puncture-resistant, leak-proof sharps containers are tion area located in every patient-care area (e.g., exam room, • Refrigerators for storing medications are cleaned chemotherapy suite, phlebotomy station) at defined intervals and when soiled, in accordance • Specifically for phlebotomy stations, a sharps with manufacturer’s instructions container is located within a short distance of each phlebotomist’s work space 7. Cleaning Spills of Blood and Body Substances • All sharps are disposed of in the designated • Wear protective gloves and use appropriate PPE sharps container; do not bend, recap, or break (e.g., use forceps to pick up any sharps and discard used syringe needles before discarding them in sharps container) into the container • If the spill contains large amounts of blood or body • Filled sharps containers are disposed of in accor- fluids (e.g., >10 mL), clean the visible matter with dance with state regulated medical waste rules disposable absorbent material and discard in appro- • Regular trash and regulated medical waste (e.g., priate containers for biohazardous waste biohazardous material and chemical hazardous • Decontaminate the area using an EPA-registered waste, including antineoplastic drugs) are disposed disinfectant with specific label claims for blood- of in their designated containers borne pathogens (e.g., HIV, HBV, HCV) or a freshly • All trash and waste containers are emptied at least diluted bleach-based product (preferably EPA-reg- daily by designated personnel istered), in accordance with manufacturer’s instruc- • Wear appropriate PPE tions, and allow the surface to dry • Handle, transport, and dispose regulated waste, • If a bleach-based product is used: including antineoplastic and hazardous drugs, in • Use a 1:100 dilution to decontaminate nonporous accordance with state and local regulations surfaces • If the spill involves large amounts of blood or CDC Guidelines for Environmental Infection Control in body fluids, use a 1:10 dilution for first application Health-Care Facilities (available at: http://www.cdc.gov/ hicpac/pdf/guidelines/eic_in_HCF_03.pdf ) of germicide before cleaning, then followed by cleaning and subsequent decontamination with CDC Guideline for Disinfection and Sterilization in Health- 1:100 dilution application care Facilities, 2008 (available at: http://www.cdc.gov/ hicpac/pdf/guidelines/Disinfection_Nov_2008.pdf) 8. Handling and Laundering Soiled Linens • Handle all contaminated linens with minimum agi- CDC Guideline for the Prevention and Control of Norovirus tation to avoid contamination of air, surfaces, and Gastroenteritis Outberaks in Healthcare Settings (available persons at: http://www.cdc.gov/hicpac/pdf/norovirus/Norovirus- • Do not sort or rinse soiled linens in patient-care areas Guideline-2011.pdf) • Use leak-resistant containment for linens contami- CDC Infection Prevention during Blood Glucose Monitoring nated with blood or body substances; ensure that and Insulin Administration (available at: http://www.cdc.gov/ there is not leakage during transport injectionsafety/blood-glucose-monitoring.html) • If laundry chutes are used, ensure that laundry bags are closed before tossing the filled bag into the APIC Infection Prevention Manual for Ambulatory Care, 2009 10 December, 2011 V . Transmission-Based Precautions In addition to consistent use of Standard Precautions, additional precautions may be warranted in certain situations as described below.

A. Identifying Potentially Infectious Patients

• Facility staff remain alert for any patient arriving • Alert registration staff ahead of time to place with symptoms of an active infection (e.g., diarrhea, the patient in a private exam room upon arriv- rash, respiratory symptoms, draining wounds or skin al if available and follow the procedures perti- lesions) nent to the route of transmission as specified • If patient calls ahead: below • Have patients with symptoms of active infection • If the purpose of the visit is non-urgent, patients come at a time when the facility is less crowded, are encouraged to reschedule the appointment if possible until symptoms have resolved

B. Contact Precautions

• Apply to patients with any of the following condi- patient’s immediate environment or belongings tions and/or disease: • Wear a gown if substantial contact with the pa- • Presence of stool incontinence (may include pa- tient or their environment is anticipated tients with norovirus, rotavirus, or Clostridium • Perform hand hygiene after removal of PPE; note: difficile), draining wounds, uncontrolled secre- use soap and water when hands are visibly soiled tions, pressure ulcers, or presence of ostomy (e.g., blood, body fluids), or after caring for patients tubes and/or bags draining body fluids with known or suspected infectious diarrhea (e.g., • Presence of generalized rash or exanthems Clostridium difficile, norovirus) • Prioritize placement of patients in an exam room if they • Clean/disinfect the exam room accordingly (refer to have stool incontinence, draining wounds and/or skin le- Section IV.F.4.) sions that cannot be covered, or uncontrolled secretions • Instruct patients with known or suspected infec- • Perform hand hygiene before touching patient and tious diarrhea to use a separate bathroom, if avail- prior to wearing gloves able; clean/disinfect the bathroom before it can be • PPE use: used again (refer to Section IV.F.5. for bathroom • Wear gloves when touching the patient and the cleaning/disinfection)

C. Droplet Precautions

• Apply to patients known or suspected to be in- cal mask, for close contact with the patient; the fected with a pathogen that can be transmitted by facemask should be donned upon entering the droplet route; these include, but are not limited to: exam room • Respiratory viruses (e.g., influenza, parainfluenza • If substantial spraying of respiratory fluids is an- virus, adenovirus, respiratory syncytial virus, hu- ticipated, gloves and gown as well as goggles (or man metapneumovirus) face shield in place of goggles) should be worn • Bordetella pertusis • Perform hand hygiene before and after touching the • For first 24 hours of therapy: Neisseria meningiti- patient and after contact with respiratory secretions des, group A streptococcus and contaminated objects/materials; note: use soap • Place the patient in an exam room with a closed and water when hands are visibly soiled (e.g., blood, door as soon as possible (prioritize patients who body fluids) have excessive cough and sputum production); if an • Instruct patient to wear a facemask when exiting the exam room is not available, the patient is provided a exam room, avoid coming into close contact with facemask and placed in a separate area as far from other patients, and practice respiratory hygiene and other patients as possible while awaiting care. cough etiquette • PPE use: • Clean and disinfect the exam room accordingly (re- • Wear a facemask, such as a procedure or surgi- fer to Section IV.F.4.)

11 December, 2011 D. Airborne Precautions

• Apply to patients known or suspected to be in- • If substantial spraying of respiratory fluids is an- fected with a pathogen that can be transmitted by ticipated, gloves and gown as well as goggles or airborne route; these include, but are not limited to: face shield should be worn • Tuberculosis • Perform hand hygiene before and after touching the • Measles patient and after contact with respiratory secretions • Chickenpox (until lesions are crusted over) and/or body fluids and contaminated objects/mate- • Localized (in immunocompromised patient) or rials; note: use soap and water when hands are vis- disseminated herpes zoster (until lesions are ibly soiled (e.g., blood, body fluids) crusted over) • Instruct patient to wear a facemask when exiting • Have patient enter through a separate entrance to the exam room, avoid coming into close contact the facility (e.g., dedicated isolation entrance), if with other patients , and practice respiratory hy- available, to avoid the reception and registration area giene and cough etiquette • Place the patient immediately in an airborne infec- • Once the patient leaves, the exam room should re- tion isolation room (AIIR) main vacant for generally one hour before anyone • If an AIIR is not available: enters; however, adequate wait time may vary de- • Provide a facemask (e.g., procedure or surgical pending on the ventilation rate of the room and mask) to the patient and place the patient im- should be determined accordingly* mediately in an exam room with a closed door • If staff must enter the room during the wait time, • Instruct the patient to keep the facemask on they are required to use respiratory protection while in the exam room, if possible, and to change *Francis J. Curry National Tuberculosis Center, FAQ: “How the mask if it becomes wet long does it take to clear the air in an isolation or high-risk • Initiate protocol to transfer patient to a health- procedure room?” (Available at: http://www.flpic.com/TB_ care facility that has the recommended infection- air_exchange.pdf) control capacity to properly manage the patient • PPE use: CDC 2007 Guideline for Isolation Precautions (available at: • Wear a fit-tested N-95 or higher level dispos- http://www.cdc.gov/hicpac/pdf/isolation/Isolation2007.pdf) able respirator, if available, when caring for the CDC Guidelines for Preventing the Transmission of Myco- patient; the respirator should be donned prior to bacterium tuberculosis in Health-Care Settings, 2005 (Avail- room entry and removed after exiting room able at: http://www.cdc.gov/mmwr/pdf/rr/rr5417.pdf)

VI . Central Venous Catheters

The procedures outlined below pertain to the access Access Devices Guidelines and the Infusion Nursing and maintenance of long-term central venous cath- Society Standards of Practice. There is not a consen- eters (e.g., vascular access devices). These include pe- sus over the use of clean versus sterile gloves when ripherally inserted central catheters (PICCs), tunneled accessing certain vascular access devices, such as catheters (e.g., Broviac®, Hickman®, and Groshong® implanted ports; where indicated, recommendations catheters), including tunneled apheresis catheters, by specific professional societies are provided. While and implanted ports. For other types of access de- the recommendations below apply generally, health- vices, such as intraperitoneal ports, refer to guidelines care personnel are to follow manufacturers’ instruc- from relevant professional societies (e.g., Oncology tions and labeled use for specific care and mainte- Nursing Society). nance. Only healthcare personnel who have attained Several recommendations in this section have been and maintained competency should perform these adapted directly from the Oncology Nursing Society procedures.

A. General Maintenance and Access Procedures

1. Accessing Central Venous Catheters • Perform hand hygiene and assemble the necessary This procedure applies only to PICCs and tunneled equipment catheters, including apheresis catheters. Refer to Part • Wear clean gloves D.1. below for accessing implanted ports. In general, • Scrub the injection cap (e.g., needleless connector) closed catheter access systems should be used pref- with an appropriate antiseptic (e.g., chlorhexidine, povi- erentially over open systems. done iodine, or 70% alcohol), and allow to dry (if povi- • Maintain aseptic technique done iodine is used, it should dry for at least 2 minutes) 12 December, 2011

• Access the injection cap with the syringe or IV tub- catheters, including apheresis catheters. ing (opening the clamp, if necessary) • Supplies for site cleansing and dressing changes • Perform hand hygiene when done should be single-use; refer to manufacturer’s rec- ommendations to ensure compatibility with the 2. Blood Draws from Central Venous Catheters catheter material • Access the catheter as outlined above, maintaining • Maintain aseptic technique aseptic technique • Perform hand hygiene • Remove the first 3-5 mL of blood and discard • Wear clean or sterile gloves (additional precaution • Obtain specimen per Infusion Nursing Society includes use of face- • Flush with 10-20 mL of normal saline (clamping the masks and sterile gloves) catheter as flushing is completed, if necessary) and • Remove existing dressing and inspect the site visually promptly dispose of used syringe(s) • Apply antiseptic to the site using >0.5% chlorhexi- • Perform hand hygiene when done dine preparation with alcohol; if there is contrain- dication to chlorhexidine, use tincture of iodine, an 3. Flushing Technique iodophor, or 70% alcohol as alternative Refer to the manufacturer’s instructions of the cath- • Do not apply topical antibiotic ointment or creams eter and the needleless connector for the appropriate to catheter site technique to use; unless otherwise specified, perform • Cover with either sterile gauze or sterile, transparent, the following: semipermeable dressing (refer to catheter-specific • Single-use flushing systems (e.g., single-dose vials, recommendations for frequency of dressing changes) prefilled syringes) should be used • Perform hand hygiene when done • Access the catheter as outlined above, maintaining aseptic technique 5. Changing the Injection Cap (e.g., Needleless • In general, avoid using a syringe less than 3 mL in Connector) size to flush, preferably use 10 mL This procedure applies only to PICCs and tunneled • Flush the catheter vigorously using pulsating tech- catheters, including apheresis catheters. Refer to man- nique and maintain pressure at the end of the flush ufacturer’s instructions for how frequently to change to prevent reflux the injection cap; if information is not available, in gen- • Positive pressure technique (may not apply to eral, change every week or when there are signs of neutral-displacement or positive-displacement blood, precipitate, cracks, leaks, or other defects, or needleless connectors): when the septum is no longer intact. i. Flush the catheter, continue to hold the plung- • Maintain aseptic technique er of the syringe while closing the clamp on • Perform hand hygiene and assemble the necessary the catheter and then disconnect the syringe equipment ii. For catheters without a clamp, withdraw the • Wear clean gloves syringe as the last 0.5-1 mL of fluid is flushed • Scrub the injection cap and catheter hub with ap- • Promptly dispose of used syringe(s) propriate antiseptic agent; clamp the catheter if • Perform hand hygiene when done necessary as cap is removed • Attach new cap to catheter hub using aseptic 4. Changing Catheter Site Dressing technique This procedure applies only to PICCs and tunneled • Perform hand hygiene when done

B. Peripherally Inserted Central Catheters (PICCs)

Refer to steps 1-5 in Section VI.A. above for PICC • Gauze dressing: change every 2 days or as need- access and common maintenance procedures. Ad- ed if wet, soiled, or nonocclusive ditional recommendations for routine maintenance • Flushing: use of heparin flushes and the recom- and care: mended concentration and frequency of flushing • Frequency of dressing change: are determined in accordance with manufacturer’s • Change 24 hours after insertion instructions and per the treating clinician’s orders (in • Transparent dressing: change every 5-7 days un- general, for valve catheters or closed tip catheters, less soiled or loose flush with normal saline unless otherwise specified)

13 December, 2011 C. Tunneled Catheters

Tunneled catheters include Broviac®, Hickman®, and as needed if wet, soiled, or nonocclusive Groshong® catheters, as well as apheresis catheters. • Once healed, tunneled catheters may go without Refer to steps 1-5 in Section VI.A. above for catheter a dressing unless the patient is immunocompro- access and common maintenance procedures. Addi- mised tional recommendations for routine maintenance and • Flushing: use of heparin flushes and the recom- care: mended concentration and frequency of flushing • Frequency of dressing change: are determined in accordance with manufacturer’s • Change 24 hours after insertion instructions and per the treating clinician’s orders • Transparent dressing: change not more than (in general, for Groshong® catheters, valve cathe- once a week unless soiled or loose ters, or closed tip catheters, flush with normal saline • Gauze and tape dressing: change every 2 days or unless otherwise specified)

D. Implanted Ports

1. Port Access Procedure with the other hand; maintain positive pressure • Perform hand hygiene first; prior to each access, ex- while deaccessing by flushing the catheter while amine the site for complications, including exami- withdrawing the needle from the septum nation of the veins of the chest and neck to look • Promptly dispose of needle and syringe for any swelling, erythema, drainage or leakage, or • Apply bandage or dressing presence of pain, discomfort, or tenderness • Perform hand hygiene when done • Palpate the outline of the portal body • Perform hand hygiene again; wear clean or sterile 3. Maintenance and Care gloves (additional precaution per INS includes use • For short-term use in outpatient settings, a light of sterile gloves and facemasks) dressing may be used in place of an occlusive dress- • Cleanse port site with appropriate antiseptic agent ing during the infusion; ensure the needle is secure • Administer topical anesthetic, if ordered in the portal septum as described above • Stabilize portal body with one hand, and insert non- • Use of heparin flushes and the recommended con- coring needle (e.g., Huber needle) with the other centration and frequency of flushing are to be de- hand until portal backing is felt termined in accordance with manufacturer’s instruc- • Ensure patency by blood return and dispose of used tions and per the treating clinician’s order (in general, syringe(s) when not in use, implanted ports should be accessed • Stabilize needle/port with tape, securement device, and flushed every 4-8 weeks to maintain patency) or stabilization device; apply gauze and tape for • For blood specimens: discard 5-10 mL of blood, ob- short-term use (such as for outpatient treatment) tain specimen, flush with 10-20 mL of normal saline, • Perform hand hygiene when done and promptly discard used syringe(s)

2. Port De-access Procedure Adapted with permission from Access Device Guidelines: • Perform hand hygiene; wear clean or sterile gloves Recommendations for Nursing Practice and Education (3rd , by D. Camp-Sorrell (Ed.), 2011, Pittsburgh, PA: Oncol- • Remove dressing and inspect site Ed.) ogy Nursing Society. Copyright 2011 by ONS. • Remove gloves, perform hand hygiene again, and wear new gloves INS 2011 Infusion Nursing Standards of Practice • Flush device with 20 mL normal saline followed by heparin flush, unless otherwise specified by manu- CDC Guidelines for the Prevention of Intravascular Catheter- facturer and/or treating clinician Related Infections, 2011 (available at: http://www.cdc.gov/ • Stabilize port with one hand, and remove needle hicpac/pdf/guidelines/bsi-guidelines-2011.pdf)

14 December, 2011 Appendix A. Example List of Contact Persons and Roles/Responsibilities

Contact Person(s)a Contact Information Roles/Responsibilities (Names/Titles)

Phone: • Infection prevention personnel/consultant Pager: • Assists with infection control plan development, update/revision, and implementation Email: • Including a protocol for transferring patients who require Airborne Precautions (if applicable)

Phone: • Educate and train facility staff (including Environmental Services/housekeeping) Pager: • Assess for competency of jobs/tasks (examples provided): Email: • Hand hygiene performance/compliance • Proper use of PPE • Environmental cleaning/disinfection • Triage/screening, taking vital signs • Phlebotomy service • Determine when to implement enhanced respiratory screening measures • Ensure facility sick leave policies are in place and followed

Phone: • Collect, manage, and analyze HAI data for surveillance purposes Pager: • Prepare and distribute surveillance reports • Notifies state and local health departments of reportable Email: diseases/conditions and outbreaks

Phone: • Provides fit-testing for N-95 respirators (if used in facility) and Pager: appropriate respiratory protection training to facility staff Email:

Phone: • Assess patients presenting with symptoms of active infection (may be notified by registration staff upon patient arrival) Pager: • Determine patient placement as needed Email:

Phone: Environmental Services (ES) /housekeeping staff Pager: • Responsible for (specify tasks, examples provided): • Ensure supplies are restocked Email: • Daily cleaning of patient-care areas • Disinfect bathrooms as needed • Cleaning large spills of blood or other potentially infectious materialsb • Empty regular trash and dispose regulated waste accordingly

Phone: • Clean/disinfect areas and/or surfaces that require more frequent Pager: cleaning or are not routinely cleaned by ES/housekeeping staff (specify areas/surfaces and specific situations, examples Email: provided): • Medication preparation area after each patient encounter • Patient-care devices after each use • Exam rooms and/or chemotherapy suite after each patient encounter (e.g., change paper covering exam table, clean chemotherapy chair) • Patient-care areas after contamination with body fluidsc

Phone: • Monitor medication/vaccine refrigerator temperature log Pager: • Ensure alternative storage method is in place in the event of power failure (specify method) Email:

a Several roles/tasks may be performed by the same person, e.g., Infection Prevention personnel, or by more than one person. b Cleaning/disinfection of spills of blood or other potentially infectious materials should be assigned to personnel trained to handle such situations; this may include facility staff other than ES/housekeeping staff. c Ensure this task is assigned to personnel who are available to respond in a timely manner; in some facilities, ES/housekeeping staff may be better equipped to handle this type of cleaning/disinfection.

15 December, 2011 Appendix B. Reportable Diseases/Conditions

[Insert a list of reportable disease/conditions specific website and/or at the following weblink: to your state and the appropriate contact information for your local and state health authorities. This informa- tion may be found at your state department of health

16 December, 2011 Appendix C. CDC Infection Prevention Checklist for Outpatient Settings

Minimum Expectations for Safe Care Certain sections may not apply (e.g., some settings The following checklist is a companion to the Guide may not perform sterilization or high-level disinfec- to Infection Prevention for Outpatient Settings: Mini- tion). If the answer to any of the listed questions is No, mum Expectations for Safe Care. The checklist should efforts should be made to correct the practice, appro- be used: priately educate healthcare personnel (if applicable), 1. To ensure that the facility has appropriate infection and determine why the correct practice was not be- prevention policies and procedures in place and ing performed. Consideration should also be made for supplies to allow healthcare personnel to provide determining the risk posed to patients by the deficient safe care. practice. Certain infection control lapses (e.g., re-use 2. To systematically assess personnel adherence to of syringes on more than one patient or to access a correct infection prevention practices. (Assessment medication container that is used for subsequent of adherence should be conducted by direct obser- patients; re-use of lancets) can result in bloodborne vation of healthcare personnel during the perfor- pathogen transmission and should be halted immedi- mance of their duties.) ately. Identification of such lapses warrants immediate Facilities using this checklist should identify all pro- consultation with the state or local health department cedures performed in their ambulatory setting and re- and appropriate notification and testing of potentially fer to appropriate sections to conduct their evaluation. affected patients.

Section I: Administrative Policies and Facility Practices

If answer is no, document Facility Policies Practice Performed plan for remediation

A . Written infection prevention policies and procedures are available, current, and based on evidence-based guidelines (e.g., CDC/HICPAC), regulations, or standards Yes No Note: Policies and procedures should be appropriate for the services provided by the facility and should extend beyond OSHA bloodborne pathogen training

B . Infection prevention policies and procedures are re-assessed at least annually or according to state or Yes No federal requirements

C . At least one individual trained in infection prevention Yes No is employed by or regularly available to the facility

D . Supplies necessary for adherence to Standard Precautions are readily available Yes No Note: This includes hand hygiene products, personal protective equipment, and injection equipment

General Infection Prevention Education and Training

A. Healthcare Personnel (HCP) receive job-specific training on infection prevention policies and procedures upon hire and at least annually or Yes No according to state or federal requirements Note: This includes those employed by outside agencies and available by contract or on a volunteer basis to the facility

B. Competency and compliance with job-specific infection prevention policies and procedures are Yes No documented both upon hire and through annual evaluations/assessments

17 December, 2011

Occupational Health

For additional guidance on occupational health recommendations consult the following resource(s):

Guideline for Infection Control in Healthcare Personnel available at: http://www.cdc.gov/hicpac/pdf/InfectControl98.pdf

Immunization of HealthCare Personnel, guidance available at: http://www.cdc.gov/vaccines/spec-grps/hcw.htm

RESOURCES  Occupational Safety & Health Administration (OSHA) Bloodborne Pathogens and Needlestick Prevention Standards available at: http://www.osha.gov/SLTC/bloodbornepathogens/index.html

A . HCP are trained on the OSHA bloodborne pathogen standard upon hire and at least annually Yes No

B. The facility maintains a log of needlesticks, sharps injuries, and other employee exposure events Yes No

C. Following an exposure event, post-exposure evaluation and follow-up, including prophylaxis as Yes No appropriate, are available at no cost to employee and are supervised by a licensed healthcare professional

D . Hepatitis B vaccination is available at no cost to all employees who are at risk of occupational exposure Yes No

E . Post-vaccination screening for protective levels of hepatitis B surface antibody is conducted after third Yes No vaccine dose is administered

F. All HCP are offered annual influenza vaccination at Yes No no cost

G. All HCP who have potential for exposure to tuberculosis (TB) are screened for TB upon hire and Yes No annually (if negative)

H . The facility has a respiratory protection program that details required worksite-specific procedures Yes No and elements for required respirator use

I . Respiratory fit testing is provided at least annually to Yes No appropriate HCP

J. Facility has written protocols for managing/ preventing job-related and community-acquired infections or important exposures in HCP, including Yes No notification of appropriate Infection Prevention and Occupational Health personnel when applicable

Surveillance and Disease Reporting

A . An updated list of diseases reportable to the public Yes No health authority is readily available to all personnel

B. The facility can demonstrate compliance with mandatory reporting requirements for notifiable Yes No diseases, healthcare associated infections, and for potential outbreaks

18 December, 2011

Hand Hygiene

For additional guidance on hand hygiene and resources for training and measurement of adherence consult the following resource(s):

Guideline for Hand Hygiene in Healthcare Settings available at: http://www.cdc.gov/mmwr/PDF/rr/rr5116.pdf Hand Hygiene in Healthcare Settings available at: http://www.cdc.gov/handhygiene/ RESOURCES List of tools that can be used to measure adherence to hand hygiene available at: http://www.jointcommission.org/assets/1/18/hh_monograph.pdf

A . The facility provides supplies necessary for adherence to hand hygiene (e.g., soap, water, paper Yes No towels, alcohol-based hand rub) and ensures they are readily accessible to HCP in patient care areas

B . HCP are educated regarding appropriate indications for hand washing with soap and water versus hand rubbing with alcohol-based hand rub

Note: Soap and water should be used when bare hands are Yes No visibly soiled (e.g., blood, body fluids) or after caring for a patient with known or suspected infectious diarrhea (e.g., Clostridium difficile or norovirus). In all other situations, alcohol-based hand rub may be used.

C . The facility periodically monitors and records adherence to hand hygiene and provides feedback to personnel regarding their performance Yes No Examples of tools used to record adherence to hand hygiene: http://www.jointcommission.org/assets/1/18/ hh_monograph.pdf

Personal Protective Equipment (PPE)

For additional guidance on personal protective equipment consult the following resource(s): 2007 Guidelines for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings available at: http://www.cdc.gov/hicpac/pdf/isolation/Isolation2007.pdf RESOURCES A . The facility has sufficient and appropriate PPE Yes No available and readily accessible to HCP

B . HCP receive training on proper selection and use of PPE Yes No

Injection Safety

For additional guidance on injection safety consult the following resource(s): 2007 Guidelines for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings available at: http://www.cdc.gov/hicpac/pdf/isolation/Isolation2007.pdf CDC Injection Safety Web Materials available at: http://www.cdc.gov/injectionsafety/ Frequently Asked Questions (FAQs) regarding Safe Practices for Medical Injections available at: RESOURCES http://www.cdc.gov/injectionsafety/providers/provider_faqs.html CDC training video and related Safe Injection Practices Campaign materials available at: http://www.oneandonlycampaign.org/

19 December, 2011

Injection Safety

A. Medication purchasing decisions at the facility reflect selection of vial sizes that most appropriately Yes No fit the procedure needs of the facility and limit need for sharing of multi-dose vials

B. Injections are required to be prepared using aseptic technique in a clean area free from contamination Yes No or contact with blood, body fluids or contaminated equipment

C. Facility has policies and procedures to track HCP access to controlled substances to prevent narcotics Yes No theft/diversion

Respiratory Hygiene/Cough Etiquette

For additional guidance on respiratory hygiene/cough etiquette consult the following resource(s): 2007 Guidelines for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings available at: http://www.cdc.gov/hicpac/pdf/isolation/Isolation2007.pdf

RESOURCES Recommendations for preventing the spread of influenza available at: http://www.cdc.gov/flu/professionals/infectioncontrol/

A . The facility has policies and procedures to contain Yes No respiratory secretions in persons who have signs and symptoms of a respiratory infection, beginning at point of entry to the facility and continuing through the duration of the visit. Measures include: i.  Posting signs at entrances (with instructions to Yes No patients with symptoms of respiratory infection to cover their mouths/ noses when coughing or sneezing, use and dispose of tissues, and perform hand hygiene after hands have been in contact with respiratory secretions) ii . Providing tissues and no-touch receptacles for Yes No disposal of tissues iii . Providing resources for performing hand Yes No hygiene in or near waiting areas iv. Offering facemasks to coughing patients and Yes No other symptomatic persons upon entry to the facility

v. Providing space and encouraging persons with Yes No symptoms of respiratory infections to sit as far away from others as possible. If available, facilities may wish to place these patients in a separate area while waiting for care

B . The facility educates HCP on the importance of infection prevention measures to contain respiratory secretions to prevent the spread of respiratory Yes No pathogens when examining and caring for patients with signs and symptoms of a respiratory infection

20 December, 2011

Environmental Cleaning

For additional guidance on environmental cleaning consult the following resource(s): Guidelines for Environmental Infection Control in Healthcare Facilities available at: http://www.cdc.gov/hicpac/pdf/guidelines/eic_in_HCF_03.pdf RESOURCES A. Facility has written policies and procedures for routine cleaning and disinfection of environmental services, including identification of responsible Yes No personnel

B. Environmental services staff receive job-specific training and competency validation at hire and when Yes No procedures/policies change

C . Training and equipment are available to ensure that HCP wear appropriate PPE to preclude exposure Yes No to infectious agents or chemicals (PPE can include gloves, gowns, masks, and eye protection)

D . Cleaning procedures are periodically monitored and assessed to ensure that they are consistently and Yes No correctly performed

E. The facility has a policy/procedure for decontamination of spills of blood or other body Yes No fluids

Reprocessing of Reusable Medical Devices

The following basic information allows for a general assessment of policies and procedures related to reprocessing of reusable medical devices . Ambulatory facilities that are providing on-site sterilization or high-level disinfection of reusable medical equipment should refer to the more detailed checklists related to sterilization and high-level disinfection in separate sections of this document devoted to those issues .

Critical items (e.g., surgical instruments) are objects that enter sterile tissue or the vascular system and must be sterile prior to use (see Sterilization Section) .

Semi-critical items (e.g. , endoscopes for upper and , vaginal probes) are objects that contact mucous membranes or non-intact skin and require, at a minimum, high-level disinfection prior to reuse (see High-level Disinfection Section) .

Non-critical items (e.g., blood pressure cuffs) are objects that may come in contact with intact skin but not mucous membranes and should undergo cleaning and low- or intermediate-level disinfection depending on the nature and degree of contamination .

Single-use devices (SUDs) are labeled by the manufacturer for a single use and do not have reprocessing

RESOURCES instructions. They may not be reprocessed for reuse except by entities which have complied with FDA regulatory requirements and have received FDA clearance to reprocess specific SUDs .

Note: Pre-cleaning must always be performed prior to sterilization and/or disinfection For additional guidance on reprocessing of medical devices consult the manufacturer instructions for the device and the following resource(s): Guideline for Disinfection and Sterilization in Healthcare Facilities available at: http://www.cdc.gov/hicpac/pdf/guidelines/Disinfection_Nov_2008.pdf FDA regulations on reprocessing of single-use medical devices available at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm071434

21 December, 2011

Reprocessing of Reusable Medical Devices

A . Facility has policies and procedures to ensure that reusable medical devices are cleaned and reprocessed appropriately prior to use on another patient Yes No Note: This includes clear delineation of responsibility among HCP

B . Policies, procedures, and manufacturer reprocessing instructions for reusable medical devices used in the Yes No facility are available in the reprocessing area(s)

C . HCP responsible for reprocessing reusable medical devices are appropriately trained and competencies Yes No are regularly documented (at least annually and when new equipment is introduced)

D . Training and equipment are available to ensure that HCP wear appropriate PPE to prevent exposure to infectious agents or chemicals (PPE can include gloves, gowns, masks, and eye protection) Yes No

Note: The exact type of PPE depends on infectious or chemical agent and anticipated type of exposure

Sterilization of Reusable Instruments and Devices

For additional guidance on sterilization of medical devices consult the manufacturer instructions for the device and the following resource(s): Guideline for Disinfection and Sterilization in Healthcare Facilities available at: http://www.cdc.gov/hicpac/pdf/guidelines/Disinfection_Nov_2008.pdf RESOURCES A . All reusable critical instruments and devices are Yes No sterilized prior to reuse

B . Routine maintenance for sterilization equipment is performed according to manufacturer instructions Yes No (confirm maintenance records are available)

C . Policies and procedures are in place outlining facility response (i.e., recall of device and risk assessment) Yes No in the event of a reprocessing error/failure

High-Level Disinfection of Reusable Instruments and Devices

For additional guidance on reprocessing of high-level disinfection devices consult the manufacturer instructions for the device and the following resource(s): Guideline for Disinfection and Sterilization in Healthcare Facilities available at: http://www.cdc.gov/hicpac/pdf/guidelines/Disinfection_Nov_2008.pdf RESOURCES A . All reusable semi-critical items receive at least high- Yes No level disinfection prior to reuse

B. The facility has a system in place to identify which instrument (e.g., endoscope) was used on a patient Yes No via a log for each procedure

C . Routine maintenance for high-level disinfection equipment is performed according to manufacturer Yes No instructions; confirm maintenance records are available

22 December, 2011

Section II: Personnel and Patient-care Observations

If answer is no, document Hand hygiene performed correctly Practice Performed plan for remediation

A. Before contact with the patient or their immediate Yes No care environment (even if gloves are worn)

B. Before exiting the patient’s care area after touching the patient or the patient’s immediate environment Yes No (even if gloves are worn)

C. Before performing an aseptic task (e.g., insertion of IV Yes No or preparing an injection) (even if gloves are worn)

D. After contact with blood, body fluids or Yes No contaminated surfaces (even if gloves are worn)

E . When hands move from a contaminated-body site to a clean-body site during patient care (even if gloves Yes No are worn)

Personal Protective Equipment (PPE) is correctly used

A . PPE is removed and discarded prior to leaving the Yes No patient’s room or care area

B . Hand hygiene is performed immediately after Yes No removal of PPE

C . Gloves: i. HCP wear gloves for potential contact with Yes No blood, body fluids, mucous membranes, non- intact skin, or contaminated equipment ii . HCP do not wear the same pair of gloves for the Yes No care of more than one patient

iii . HCP do not wash gloves for the purpose of reuse Yes No

D. Gowns: i. HCP wear gowns to protect skin and clothing Yes No during procedures or activities where contact with blood or body fluids is anticipated ii . HCP do not wear the same gown for the care of Yes No more than one patient

E . Facial protection: i. HCP wear mouth, nose, and eye protection Yes No during procedures that are likely to generate splashes or sprays of blood or other body fluids ii. HCP wear a facemask (e.g., surgical mask) Yes No when placing a catheter or injecting material into the epidural or subdural space (e g. ., during myelogram, epidural or spinal )

23 December, 2011

Injection safety

A . Needles and syringes are used for only one patient (this includes manufactured prefilled syringes and Yes No cartridge devices such as insulin pens)

B . The rubber septum on a medication vial is Yes No disinfected with alcohol prior to piercing

C. Medication vials are entered with a new needle and a new syringe, even when obtaining additional doses Yes No for the same patient

D . Single dose (single-use) medication vials, ampules, and bags or bottles of intravenous solution are used Yes No for only one patient

E. Medication administration tubing and connectors are Yes No used for only one patient

F. Multi-dose vials are dated by HCP when they are first opened and discarded within 28 days unless the manufacturer specifies a different (shorter or longer) date for that opened vial Yes No

Note: This is different from the expiration date printed on the vial

G. Multi-dose vials are dedicated to individual patients Yes No whenever possible

H. Multi-dose vials to be used for more than one patient are kept in a centralized medication area and do not enter the immediate patient treatment area (e.g,. operating room, patient room/cubicle) Yes No Note: If multi-dose vials enter the immediate patient treatment area they should be dedicated for single-patient use and discarded immediately after use

I . All sharps are disposed of in a puncture-resistant Yes No sharps container

J . Filled sharps containers are disposed of in Yes No accordance with state regulated medical waste rules

K . All controlled substances (e g. ,. Schedule II, III, IV, V drugs) are kept locked within a secure area Yes No

Point-of-Care Testing (e.g., blood glucose meters, INR monitor)

For additional guidance on infection prevention during point-of-care testing consult the following resource(s): Infection Prevention during Blood Glucose Monitoring and Insulin Administration available at: http://www.cdc.gov/injectionsafety/blood-glucose-monitoring.html  Frequently Asked Questions (FAQs) regarding Assisted Blood Glucose Monitoring and Insulin

RESOURCES Administration available at: http://www.cdc.gov/injectionsafety/providers/blood-glucose-monitoring_faqs.html

24 December, 2011

Point-of-Care Testing (e.g., blood glucose meters, INR monitor)

A. New single-use, auto-disabling lancing device is used for each patient Yes No Note: Lancet holder devices are not suitable for multi- patient use

B . If used for more than one patient, the point-of-care testing meter is cleaned and disinfected after every use according to manufacturer instructions Yes No Note: If the manufacturer does not provide instructions for cleaning and disinfection, then the testing meter should not be used for >1 patient

Environmental Cleaning

A. Environmental surfaces, with an emphasis on surfaces in proximity to the patient and those Yes No that are frequently touched, are cleaned and then disinfected with an EPA-registered disinfectant

B . Cleaners and disinfectants are used in accordance with manufacturer instructions (e.g., dilution, Yes No storage, shelf-life, contact time)

Reprocessing of Reusable Instruments and Devices

A . Reusable medical devices are cleaned, reprocessed (disinfection or sterilization) and maintained according to the manufacturer instructions . Yes No Note: If the manufacturer does not provide such instructions, the device may not be suitable for multi- patient use

B . Single-use devices are discarded after use and not used for more than one patient .

Note: If the facility elects to reuse single-use devices, these devices must be reprocessed prior to reuse by a third-party reprocessor that it is registered with the FDA as a third- Yes No party reprocessor and cleared by the FDA to reprocess the specific device in question. The facility should have documentation from the third party reprocessor confirming this is the case.

C. Reprocessing area has a workflow pattern such that devices clearly flow from high contamination areas Yes No to clean/sterile areas (i.e., there is clear separation between soiled and clean workspaces)

D. Medical devices are stored in a manner to protect Yes No from damage and contamination

25 December, 2011

Sterilization of Reusable Instruments and Devices

A . Items are thoroughly pre-cleaned according to manufacturer instructions and visually inspected for residual soil prior to sterilization Yes No Note: For lumened instruments, device channels and lumens must be cleaned using appropriately sized cleaning brushes

B . Enzymatic cleaner or detergent is used for pre- cleaning and discarded according to manufacturer Yes No instructions (typically after each use)

C . Cleaning brushes are disposable or cleaned and high-level disinfected or sterilized (per manufacturer Yes No instructions) after each use

D . After pre-cleaning, instruments are appropriately wrapped/packaged for sterilization (e.g., package system selected is compatible with the sterilization Yes No process being performed, hinged instruments are open, instruments are disassembled if indicated by the manufacturer)

E . A chemical indicator (process indicator) is placed Yes No correctly in the instrument packs in every load

F. A biological indicator is used at least weekly for each sterilizer and with every load containing Yes No implantable items

G. For dynamic air removal-type sterilizers, a Bowie- Dick test is performed each day the sterilizer is used Yes No to verify efficacy of air removal

H. Sterile packs are labeled with the sterilizer used, the Yes No cycle or load number, and the date of sterilization

I . Logs for each sterilizer cycle are current and include Yes No results from each load

J . After sterilization, medical devices and instruments Yes No are stored so that sterility is not compromised

K. Sterile packages are inspected for integrity and Yes No compromised packages are reprocessed prior to use

L. Immediate-use steam sterilization (flash sterilization), if performed, is only done in Yes No circumstances in which routine sterilization procedures cannot be performed

M. Instruments that are flash-sterilized are used Yes No immediately and not stored

26 December, 2011

High-Level Disinfection of Reusable Instruments and Devices

A. Flexible endoscopes are inspected for damage and Yes No leak tested as part of each reprocessing cycle

B . Items are thoroughly pre-cleaned according to manufacturer instructions and visually inspected for residual soil prior to high-level disinfection Yes No Note: For lumened instruments, device channels and lumens must be cleaned using appropriately sized cleaning brushes

C .Enzymatic cleaner or detergent is used and discarded according to manufacturer instructions Yes No (typically after each use)

D . Cleaning brushes are disposable or cleaned and high-level disinfected or sterilized (per manufacturer Yes No instructions) after each use

E . For chemicals used in high-level disinfection, manufacturer instructions are followed for: i . preparation Yes No ii . testing for appropriate concentration iii. replacement (i.e., prior to expiration or loss of efficacy)

F . If automated reprocessing equipment is used, proper connectors are used to assure that channels Yes No and lumens are appropriately disinfected

G .Devices are disinfected for the appropriate length of Yes No time as specified by manufacturer instructions

H . Devices are disinfected at the appropriate temperature as specified by manufacturer Yes No instructions

I. After high-level disinfection, devices are rinsed with sterile water, filtered water, or tap water followed by Yes No a rinse with 70% - 90% ethyl or isopropyl alcohol

J . Devices are dried thoroughly prior to reuse

Note: Lumened instruments (e.g., endoscopes) require Yes No flushing channels with alcohol and forcing air through channels

K . After high-level disinfection, devices are stored in a manner to protect from damage or contamination Yes No Note: Endoscopes should be hung in a vertical position

27 December, 2011 Appendix D. Additional Resources

Infection prevention issues unique to blood and marrow transplant centers (a.k.a. bone marrow transplant or stem cell transplant centers)

Guidelines for Preventing Opportunistic Infections Among Hematopoietic Stem Cell Transplant Recipients available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/rr4910a1.htm Guidelines for Preventing Infectious Complications among Hematopoietic Cell Transplantation Recipients: A Global Perspective available at: http://www.idsociety.org/uploadedFiles/IDSA/Guidelines-Patient_

RESOURCES Care/PDF_Library/OI.pdf)

Occupational health requirements, including bloodborne pathogen training, healthcare personnel immunizations, and recommended personal protective equipment for handling antineoplastic agents and other hazardous drugs

Guideline for infection control in healthcare personnel available at: http://www.cdc.gov/hicpac/pdf/ InfectControl98.pdf) Immunization of Health-Care Workers: Recommendations of the Advisory Committee on Immunization available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/00050577.htm OSHA Bloodborne Pathogens and Needlestick Prevention available at: http://www.osha.gov/SLTC/ bloodbornepathogens/index.html OSHA Controlling Occupational Exposure to Hazardous Drugs available at: http://www.osha.gov/dts/osta/ otm/otm_vi/otm_vi_2.html NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings 2010 available at: http:// RESOURCES www.cdc.gov/niosh/docs/2010-167/pdfs/2010-167.pdf NIOSH Personal Protective Equipment for Workers Who Work with Hazardous Drugs available at: http://www.cdc.gov/niosh/docs/wp-solutions/2009-106/pdfs/2009-106.pdf NIOSH Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health Care Settings available at: http://www.cdc.gov/niosh/docs/2004-165/pdfs/2004-165.pdf

Appropriate preparation and handling (e.g., reconstituting, mixing, diluting, compounding) of sterile medications, including antineoplastic agents

United States Pharmacopeia Chapter <797> Guidebook to Pharmaceutical Compounding—Sterile Preparations International Society of Oncology Pharmacy Practitioners Standards of Practice available at: http://opp. sagepub.com/content/13/3_suppl) American Society of Health-System Guidelines for Handling Hazardous Drugs available at:

RESOURCES http://www.ashp.org/DocLibrary/BestPractices/PrepGdlHazDrugs.aspx

Clinical recommendations and guidance for treatment of patients with cancer, including appropriate antimicrobial prescribing practices and prechemotherapy assessment of neutropenia risk

 National Comprehensive Cancer Network Guidelines and Clinical Resources available at: http://www.nccn. org/professionals/physician_gls/f_guidelines.asp American Society of Clinical Oncology Guidelines available at: http://www.asco.org/ASCOv2/ Practice+%26+Guidelines/Guidelines Clinical Practice Guideline for the Use of Antimicrobial Agents in Neutropenic Patients with Cancer: 2010 Update by the Infectious Diseases Society of America available: http://www.idsociety.org/uploadedFiles/

RESOURCES IDSA/Guidelines-Patient_Care/PDF_Library/FN.pdf Practice Guidelines for Outpatient Parenteral Antimicrobial Therapy available at: http://www.idsociety.org/ uploadedFiles/IDSA/Guidelines-Patient_Care/PDF_Library/OPAT.pdf

Additional Resources and Evidence-based Guidelines available at: 28 http://www.cdc.gov/HAI/prevent/prevent_pubs.html December, 2011 Notes

29 December, 2011

To learn more about CDC’s resources, please visit cdc.gov/cancer/preventinfections