This policy applies to all Pharmacy or non-pharmacy personnel accessing controlled work areas located within Lower Mainland Pharmacy Services.

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1 Page 1 of 13 BACKGROUND Proper hand hygiene and garbing are an essential part of the sterile compounding process to prevent patient harm from contaminated compounded sterile preparations and protect staff from drug and chemical exposure. PURPOSE To establish standard processes and outline requirements for hand hygiene and garbing for personnel working in or entering controlled work areas, in accordance with provincial legislation and standards. FOCUS This policy applies to all Pharmacy or non-pharmacy personnel accessing controlled work areas located within Lower Mainland. DEFINITIONS 2,3,4 Anteroom: An area ISO Class 7 or 8 area where personnel hand hygiene and garbing procedures, staging of components, order entry, compounded sterile product labeling, and other high-particulate-generating activities are performed. It is also a transition area that (1) provides assurance that pressure relationships are constantly maintained so that air flows from clean to dirty areas and (2) reduces the need for the heating, ventilating, and air-conditioning (HVAC) control system to respond to large disturbances. Cleanroom: An enclosed, ISO Class 7 area where the primary clean air device (e.g. cabinet, isolator, workbench, hood) is physically located. Compounded sterile preparation (CSP): A preparation intended to be sterile that is created by combining, diluting, pooling, or otherwise altering a drug product or bulk drug substance. Controlled work areas: includes anteroom, cleanroom, and segregated compounding area ISO Class: An air quality classification from the International Organization for Standardization.

2 Page 2 of 13 Line of demarcation: A line, real or virtual, that separates the anteroom or segregated compounding area into two spaces. The dirty side of the line of demarcation is located at the entrance to the anteroom, in the section adjacent to the pharmacy. The clean side of the line is adjacent to the dirty area on one side and the cleanroom on the other. It is important to take these clean and dirty areas into account when traversing the anteroom and when donning and removing personal protective equipment. Personal Protective Equipment (PPE): Equipment or clothing worn to minimize exposure to chemical hazards in the workplace, enable compliance with the expected specifications of a controlled environment and minimize potential contamination of CSPs. Primary clean air device: A device (e.g. cabinet, isolator, workbench, hood) that provides an ISO Class 5 environment for exposure of critical sites during the compounding of aseptic preparations. Segregated compounding area: A designated, unclassified space, area, or room that contains a primary clean air device for preparation of CSPs and is void of activities and materials that are extraneous to sterile compounding. POLICY General 1.1 Only authorized personnel shall enter controlled work areas 1.2 Personnel requiring access to controlled work areas shall report to the supervisor any illnesses or conditions that may adversely affect the safety or integrity of compounded sterile preparations (CSPs) as a result of excessive skin shedding or infectiousness Such illnesses or conditions include but are not limited to the following: Fever Moderate to severe sunburn with skin sloughing Visible or exposed eczema or other severe skin rash Cough, runny nose or active respiratory infection Conjunctivitis Open wounds or weeping sores, including recent tattoos Other active communicable diseases

3 Page 3 of The supervisor shall exclude affected personnel from accessing the controlled work area until the illness or condition is remedied or the potential impact on CSP safety and integrity has abated 1.3 Personnel accessing controlled work areas shall pay particular attention to personal hygiene which can affect CSP quality and the health and safety of patients Nails shall be clean and trimmed 1.4 While working in or accessing controlled work areas, personnel shall comply with hand hygiene and garb requirements as outlined in the procedures Applicable hand hygiene and garbing shall be performed each time personnel enter and leave the anteroom, cleanroom or segregated compounding area. 1.5 No food or drink, including chewing gum, candy or lozenges, shall be brought into, stored or consumed in controlled work areas Orientation 1.6 All personnel who enter controlled work areas shall receive orientation and successfully complete a hand hygiene and garbing competency assessment, prior to entering the controlled work area (See Appendix A) The hand hygiene and garbing competency assessment shall be completed annually 1.7 Personnel who have not received orientation or have not completed the competency assessment may access controlled work areas, only under the following circumstances: Must be accompanied by an oriented and qualified staff member, and Must be assisted through the complete hand hygiene and garbing process by an oriented and qualified staff member Personal Apparel 1.8 While working in or accessing controlled work areas, personnel shall not be permitted to wear the following: personal outer garments (e.g., bandanas, coats, hats, jackets, scarves, sweaters, vests)

4 Page 4 of 13 all leave-in hair products (e.g. hairspray, mousse, gel) and facial cosmetics as they shed flakes and particles (exception: non-tinted skin and lip moisturizers) all hand, wrist, neck and head jewelry nail polish and artificial nails or nail tips eyelash enhancements 1.9 While working in or accessing controlled work areas, personnel are permitted to wear the following: Eyeglasses Hearing aids Medical information, secured under the neckline of garb ID badges, secured under garb (lanyards are not permitted) Short sleeved undershirt, worn under garb 1.10 Personal electronic devices, including cell phones, music players and ear buds shall not be permitted inside controlled work areas, even when contained within a pocket Garb 1.11 While accessing controlled work areas, all personnel shall wear: Clean, low-shedding apparel Clean footwear in good condition, completely enclosing the foot from heel to toe, including covering the top side of the foot Socks or stockings covering the ankles, so that skin below the hem of the garb (scrubs) is completely covered 1.12 All personnel accessing controlled work areas beyond the line of demarcation (i.e. clean side of anteroom or segregated compounding area, cleanroom) shall wear fresh, dedicated, low-shedding apparel (i.e. scrubs) for each shift A fastened lab coat or gown shall be worn over the apparel upon exiting the controlled work area if personnel intend to reenter the controlled work area wearing the same apparel Gowns worn outside controlled work areas may not be reused upon reentering controlled work areas.

5 Page 5 of All personnel shall wear disposable or re-usable gowns in cleanrooms For hazardous drug compounding, only LMPS-approved disposable gowns resistant to fluid permeation shall be worn 1.14 Scrubs and re-usable gowns shall be Supplied by the hospital, Stored on site, and Laundered by the hospital laundry service 1.15 Eye-shields, in the form of goggles, are required for personnel performing an activity that has a high likelihood of splashing harmful substances such as cleaning products or hazardous materials Such activities include preparation of cleaning solutions, cleaning of controlled work area ceilings and walls, cleaning or decontamination of the Biological Safety Cabinet (BSC) with the viewing window raised, or cleaning up a hazardous drug spill outside the BSC 1.16 A NIOSH-certified elastomeric or N95 respirator, fit-tested annually, shall be worn when cleaning or decontaminating the BSC with the viewing window raised, or when cleaning hazardous spills outside the BSC Gloves 1.17 All personnel preparing CSPs shall wear sterile gloves personnel preparing drugs in the hazardous drug Biological Safety Cabinet shall wear two sets of sterile LMPS-approved chemotherapy gloves, with the inner pair worn under the gown cuff and the outer pair worn over the gown cuff Sterile gloves shall be worn over the isolator gloves inside the main chamber of an isolator 1.18 Personnel entering the cleanroom to perform tasks other than compounding, including observation, final verification of CSPs, cleaning areas other than the interior of the primary clean air device, and maintenance of equipment, may wear single-use nonsterile gloves donned after aseptic hand washing

6 Page 6 of The non-sterile gloves must be disinfected with sterile 70% isopropyl alcohol (sipa) after donning Non-sterile gloves worn in the hazardous drug cleanroom must be chemotherapy-approved PROCEDURE Personnel must don garb and perform hand hygiene in an order that proceeds from the dirtiest to cleanest body parts, top to bottom (head and face, feet), and takes into account the location of the line of demarcation in the facility. Each site will establish a specific order and location for hand hygiene and garbing activities. Prior to Entering the Anteroom or Segregated Compounding Area 2.1 Remove outer garments, jewelry, cosmetics 2.2 Don clean, low-shedding clothing (e.g. scrubs) 2.3 Perform routine hand hygiene (i.e. non surgical) using soap and water or alcohol based hand rub 2.4 If worn, clean eyeglasses with a low-shedding single-use cloth and eyeglass cleaning solution, sterile 70% isopropyl alcohol (sipa), soap and water or other disinfectant compatible with eyeglass materials In Anteroom or Upon Entry to Segregated Compounding Area Don Garb 2.5 Don head cover and beard cover, if required, ensuring all hair and ears are covered 2.6 Don surgical or respirator mask, ensuring coverage from the bridge of the nose to the area under the chin 2.7 Don shoe covers one at a time, or don clean shoes dedicated to the clean side of the ante-area and cleanroom only while stepping over the line of demarcation

7 Page 7 of A second pair of shoe covers should be donned if entering the hazardous cleanroom to minimize hazardous drug contamination of controlled work areas. The second pair can be donned while crossing the line of demarcation or on the clean side of the anteroom. The second pair should be removed immediately before or after exiting the hazardous drug cleanroom. Exception: A single pair of shoe covers is sufficient if the location of the line of demarcation results in both pairs of shoe covers being removed in the same location Shoe covers are single use and are not to be worn beyond the line of demarcation If used, dedicated shoes must be cleaned and disinfected weekly Perform Hand Hygiene 2.8 Wash hands and forearms up to the elbow for 30 to 60 seconds with neutral soap and water, ensuring lather is produced Measure minimum of 30 seconds by referring to the second hand of a clock or other objective means Clean nails with a disposable nail pick once each shift, during the first time that hand hygiene is performed Note: Use of nail and hand brushes is not recommended as they have been shown to cause micro-abrasions of the skin 2.9 Rinse thoroughly under running water 2.10 Dry hands and forearms thoroughly by patting with a low-shedding, single-use cloth 2.11 Turn off the water taps with the cloth and discard cloth, unless using a hands-free sink Notify supervisor if suffering from allergies or sensitivities to standard hand hygiene agents Consultation with Workplace Health and Infection Control will help determine an acceptable alternative solution

8 Page 8 of 13 Gown 2.13 Don a disposable or reusable gown that closes at the neck and has elastic cuffs. Push sleeves of gown up to prepare for application of alcohol-based hand rub For hazardous drugs, don an approved disposable gown that resists permeability On Clean Side of Anteroom or Upon Entry to the Cleanroom Gloving 2.14 Open the outer wrapper of the sterile glove package onto a clean surface, exposing the inner glove package (may occur prior to hand hygiene) 2.15 Apply alcohol-based hand rub (ABHR) with persistent activity to fingertips and all surfaces of forearms, lower gown sleeves, then apply ABHR to hands and fingers as per manufacturer s recommendations Alternatively, apply ABHR with persistent activity to fingertips and all surfaces of forearms, then don gown and reapply ABHR to hands and fingers as per ABHR manufacturer s recommendations 2.16 Allow hands to dry completely 2.17 Don sterile gloves Don the first glove with an ungloved hand by grabbing an inner surface of the glove, and sliding the hand into it and pulling it on Don the second glove by slipping the sterile gloved hand into the cuff of the second and placing the ungloved hand into the free glove Inspect both gloves for damage and replace if any defects (tears, holes and rips) are noted Ensure gloves cover cuffs of gown Gloves should be the last item donned before compounding begins When using an isolator to compound, don the sterile gloves over the isolator gloves rather than donning the sterile gloves in the anteroom area Don two pairs of sterile chemotherapy gloves for hazardous drug compounding. The cuff of the first pair goes under the gown cuff, and the cuff of the second pair goes over the gown cuff.

9 Page 9 of Sanitize all surfaces of gloved hands with sterile 70% isopropyl alcohol (sipa) Apply sipa to gloved hands and rub hands together to completely coat surfaces of gloves Allow sipa to dry completely Change Gloves 2.19 Change gloves: Every hour when preparing non-hazardous drugs Every 30 minutes when preparing hazardous drugs (both pairs) If tearing or a puncture, or contamination with hazardous drug occurs Repeat Hand Hygiene 2.20 Repeat full hand hygiene between glove changes Exception: Hands that are not visibly soiled may be cleansed with alcohol-based hand rub with persistent activity as per manufacturer s recommendations when performing non-hazardous sterile compounding Always perform full hand hygiene procedures when changing gloves due to tearing or a puncture Disinfecting Gloves 2.21 Disinfect gloved hands with sipa (wipe or pour onto gloves) at the following times: Prior to entering the primary clean air device (e.g. when placing items into the hood) Prior to commencing each new batch Any time the gloved hands re-enter the primary clean air device after making contact with non-sterile surfaces Periodically, during prolonged periods of compounding within the primary clean air device Upon Exiting the Clean Room or Segregated Compounding Area 2.22 All PPE used for hazardous compounding must be disposed of into hazardous waste receptacles

10 Page 10 of Remove gloves and discard For hazardous drug compounding, remove outer gloves inside the primary clean air device. Alternatively, outer gloves may be cleaned with a saturated wipe inside the primary clean air device and removed before exiting the cleanroom. Gloves and any wipes used shall be discarded in the hazardous waste receptacle For hazardous drug compounding, remove and dispose of inner gloves after removal of other garb in the anteroom For hazardous drug compounding, remove the outer second set of shoe covers immediately before or after exiting the hazardous drug cleanroom 2.25 Remove gown, prior to stepping over the line of demarcation into the dirty section of the anteroom Gown may be saved for subsequent use throughout the shift provided it is not visibly soiled. If retained, hang on a hook in the cleanroom or on the clean side of the anteroom. Gowns may not be shared between staff members Chemotherapy gowns must be changed every 3 hours of compounding, at minimum Chemotherapy gowns worn in the hazardous compounding cleanroom must be removed immediately before or after exiting the cleanroom to prevent the spread of hazardous drug contamination from one area to another At the end of the session or shift, discard disposable gown into appropriate waste container or place reusable gown in laundry 2.26 Remove remaining shoe covers, upon stepping over the line of demarcation into the dirty section of the anteroom, and discard 2.27 Remove and discard face mask, facial hair cover, and head cover on the dirty side of the anteroom or beyond the line of demarcation 2.28 Wash hands with soap and water

11 Page 11 of 13 REFERENCES 1. BCCA Pharmacy Practice Standards for Hazardous Drugs. BC Cancer Agency, Available from 2. Compounding: Guidelines for Pharmacies. Canadian Society of Hospital Pharmacists, Ottawa, Ontario, Model Standards for Pharmacy Compounding of Non-hazardous Sterile Products. National Association of Pharmacy Regulatory Authorities, United States Pharmacopeia, General Chapter <797>: Pharmaceutical compounding sterile preparations. USP 39, Rockville, MD, United States Pharmacopeia, General Chapter <800>: Hazardous Drugs handling in healthcare settings. USP 39, Rockville, MD,

12 Appendix A Page 12 of 13 Hand Hygiene and Garbing Competency Assessment Employee Name: Evaluator Name: Date of Evaluation: Position Title: Type: Initial Competency Ongoing Competency Other: Evaluator Position: Observations and evaluations must be made by qualified pharmacy staff. In the RATING column, the evaluator will note the following: S=satisfactory competency, U= unmet competency, N/A = not applicable, N/O= not observed Additional comment is required if any notations of U, N/A or N/O, with a specific plan to correct noted in the Remedial Plan section. SKILL RATING COMMENTS Presents in a clean appropriate attire. Removes extraneous personal clothing (scarves, vests, sweaters, hats, etc) and wears clothing that is consistent with established policy Wears no cosmetics or jewelry (watches, rings, earrings, piercings visible prior to garbing) upon entry into ante-area. Neither brings nor stores food, drink or personal electronic device in the controlled work areas. Nails are not excessively long, no artificial nails Wears appropriate shoes and socks covering ankles Changes into clean, low-shedding apparel i.e. scrubs Cleans eyeglasses, if worn Performs routine hand hygiene (soap + water or regular alcohol-based hand rub) prior to entering controlled work areas Demonstrates awareness of and performs garbing activities on correct side of the line of demarcation. Dons head cover, assures all hair covered using mirror to verify Dons face mask to cover bridge of nose down to base of chin Optional: Dons beard cover if necessary. Optional: Puts on safety goggles, if required. Dons shoe covers or designated clean shoes one at a time, placing the covered or designated shoe on the clean side of the line of demarcation as appropriate. Dons 2 pairs of shoe covers for hazardous drug compounding. Wets hands and forearms, washes using soap and water for at least 30 seconds during which nails are cleaned with disposable nail pick. Dries hands and forearms by patting with low-linting towel. Dons gown and ensures full closure. Gown may be reusable or disposable for non-hazardous compounding, but must be impervious and disposable for hazardous compounding.

13 Appendix A Page 13 of 13 SKILL RATING COMMENTS Disinfects hands again using a waterless alcohol-based surgical hand rub with persistent activity and allows hands to dry thoroughly before donning sterile gloves. Dons appropriate-sized sterile gloves. Dons 2 sets of gloves for hazardous compounding (under and over gown cuffs). Examines gloves ensuring that there are no defects or holes Routinely disinfects gloves with sterile 70% IPA prior to entering PCAD, routinely during compounding and after touching items or surfaces outside the PCAD Change gloves every hour during non-hazardous and every 30 minutes during hazardous drug compounding Performs hand hygiene between glove changes (ABHR or full hand hygiene for non-hazardous compounding or full hand hygiene for hazardous compounding) Removes gloves at end of compounding session. For hazardous drug compounding, removes outer gloves inside PCAD or wipes gloves in PCAD and removes outer pair in cleanroom. Removes inner pair after removing other hazardous compounding PPE Removes non-hazardous gown and discards it (if finished compounding for the day) or hangs on a hook in cleanroom or on the clean side of the ante-area (if not visibly soiled and is intact) where it may be reused during the same work day only Changes hazardous gown every 3 hours. Removes gown immediately before/after exiting hazardous drug cleanroom For hazardous compounding, removes outer pair of shoe covers immediately before/after exiting hazardous cleanroom. Removes remaining shoe covers or shoes one at a time when crossing line of demarcation, ensuring that the uncovered foot is placed on the dirty side of the line of demarcation Removes and discards mask, head cover and beard cover crossing over line of demarcation Disposes of all PPE for hazardous compounding in hazardous waste receptacles Washes hands with soap and water after removing garb Remedial Action Plan/Additional Comments Employee Signature Date Qualified Evaluator Signature Date