GAP IDENTIFICATION TOOL

Adapted from NAPRA Model Standards for Pharmacy Compounding of Hazardous Sterile Preparations

2017

GAP Identification Tool Instructions

Please refer to and read the Model Standards for Pharmacy Compounding of Hazardous Sterile Preparations prior to completing this gap identification tool. The questions asked in the document are based on “shall or must” statements in the Model Standards and does not include every shall or must but includes the major elements to complete an assessment of how compliant the compounding program is.

Model Standards can be found at WWW.NAPRA.ca

Each question has a drop-down list; you must choose one of the available selections.

Please answer all questions in the identification tool.

Note: You may need to consult with your engineering and maintenance department to be able to answer some of the questions related to the facility portion.

ID	Gap Identification Question(s)	Choose One Response that Accurately Represents Your Facility
1	Do all compounding personnel pass an initial gloved finger-tip sample before working in the compounding area?
2	Do all compounding personnel pass an initial media fill test before working in the compounding area for hazardous sterile products?
3	All personnel (pharmacists, pharmacy technicians and pharmacy assistants) assigned to the compounding of hazardous sterile preparations are assessed at least once a year for low or medium risk level; and at least twice a year for high risk level preparations?
4	The air supplied to areas used for compounding hazardous sterile preparations pass-through a terminally fitted high-efficiency particulate air (HEPA) filter to ensure a very high level of cleanliness?
5	Particle counts (non-viable) are performed by trained, qualified personnel at least every 6 months as part of an internal quality control program for facilities? (see Appendices 5 and 6)
6	Particle counts are performed by trained, qualified personnel at least every 6 months as part of an internal quality control program for the primary engineering control (PEC)? (see Appendices 5 and 6 in NAPRA)
7	Water sources, sinks and drains are not located in the clean room?
8	The initial training and assessment program for compounding personnel includes reading and understanding P&Ps (see appendix 1), theoretical training with assessment (see appendix 3), assessment of aseptic techniques?
9	PPE is worn for the compounding of hazardous sterile preparations includes the following: Double Shoe covers, hair cover, beard cover (if applicable), N95 or N100 mask, sterile non-powdered gloves, non-shedding gown (enclosed at neck and sleeves that fit snuggly at the wrist, and moisture resistant)?
10	Beyond-use dates are assigned according to stability and the risk level associated with microbial contamination? (Low, Medium and High risk level BUDS)
11	Before entering the anteroom, personnel always remove personal outer garments (e.g., coat, hat, jacket scarf, sweater, vest, boots and outdoor shoes)?
12	Before entering the anteroom, personnel always remove jewelry, studs and other accessories from fingers, wrists, forearms, face, tongue, ears and neck (this includes personal electronic devices or accessories, such as cell phone, iPod and earbuds, which are not permitted in the anteroom or clean room)?
13	Before entering the anteroom, personnel always remove all cosmetics, including makeup, false eyelashes, perfume, hair products such as hairspray, henna tattoos and paper tattoos?
14	Before entering the anteroom, personnel always remove nail polish and other nail applications?
15	Where packaging allows, compounding equipment and products are disinfected with sterile 70% isopropyl alcohol just before being introduced into the clean room?
16	Your pharmacy has implemented an environmental sampling plan that measures viable air and surface particles?
17	For each employee, a glove finger-tip sample is performed after the media fill test is completed annually for low-risk and medium-risk sterile compounding and every 6 months for high-risk sterile compounding?
18	The cleanroom meets ISO 14644-1 for cleanroom particulate airborne cleanliness at the ISO 7 level and there is documentation to support this?
19	Daily cleaning, decontamination and disinfecting occurs in the C-PEC, counters, carts, floors and frequently touches surfaces in the anteroom and the cleanroom where hazardous drugs are compounded? Note: review definitions of cleaning, decontamination and disinfection in NAPRA prior to answering this question.
20	Does your pharmacy prepare high-risk compounds? Note: High-risk is when non-sterile ingredients or supplies are used to create a sterile compound).
21	Cardboard does not enter the anteroom or cleanroom?
22	Alcohol based hand rub (AHBR) with persistent activity is used to perform hand antisepsis?
23	Bins used to introduce supplies or products into the cleanroom are always disinfected prior to use?
24	The cleanroom is verified to have a minimum of 30 air changes per hour (ACPH) with the air being completely exhausted to the exterior?
25	The cleanroom is verified to be kept under negative pressure relative to the anteroom. (-2.5 Pa)?
26	The anteroom is verified to have a minimum of 30 air changes per hour (ACPH)?
27	The pharmacy of the health care facility has established a committee comprised of representatives of the employer, representatives of compounding, administration personnel, and representatives of cleaning and disinfecting personnel for the compounding areas and within this team is a pharmacist or pharmacy technician to support hazardous product management?
28	Cleaning and disinfecting personnel are provided theoretical training and assessment covering the issues and particularities of cleaning and disinfecting the premises and equipment used for compounding hazardous sterile preparations as outlined in appendix 3?
29	The pharmacy has a developed list of hazardous drugs that require special handling precautions. This list is available at the pharmacy and is reviewed at least every 12 months.
30	The compounding area consists of an anteroom and a cleanroom. These rooms are each controlled and physically separated by a walls, door and pass-throughs?
31	The compounding supervisor is evaluated at the same frequency as compounding personnel, by a third-party evaluator?
32	The anteroom is separated into two spaces by a visible demarcation line. The first space is referred to as “dirty” but chemical free. The second space is referred to as “clean but chemically contaminated”.
33	Hazardous products are stored in a properly ventilated room with all air exhausted to the exterior and negative pressure relative to the adjacent rooms with at least 12 air changes per hour?
34	Oncology adjunctive therapies can also be prepared in the BSC’s or CACIs, if they are being compounded for the same patient as the hazardous sterile preparation. These adjunctive therapies are handled and labeled to require hazardous drug precautions?
35	All gloves (sterile and non-sterile) used in the unpacking, cleaning and disinfecting of the cleanroom, disinfecting the C-PEC, compounding, managing a spill and disposing of hazardous products are verified to be compliant with standards D-6978-05 of ASTM International?
36	When compounding hazardous drugs, both pairs of gloves are discarded and replaced at the earliest of the manufacture’s limit for permeation of the gloves, every 30 minutes, or immediately if a tear, puncture or contamination has occurred or is suspected?
37	The gown is tested by the manufacturer to be resistant to permeability by hazardous drugs. It closes in the back, and has long sleeves with fitted cuffs at the wrist?
38	The gown is discarded and replaced at the earliest of the manufacturers time limit for permeation of the gown or after 2-3 hours of continuous compounding work or after each removal or after a contamination has occurred or is suspected?
39	A disposable hair cover is worn during compounding and it is discarded after each removal (not saved for re-use or worn outside of ante-room)?
40	A chemical cartridge respirator with a pre-filter is worn in the presence of vapours, gas and particles (e.g. dust) or if there has been a spill? (NAPRA page 36) *Note: In this case, an N95 or N100 NIOSH-approved mask offers no protection from vapours, and gases and splashes.
41	The mask worn during compounding is changed at the earliest of the following: after 3.5 hours of continuous compounding, after each removal or if contamination is suspected?
42	Goggles and a face shield or full face-piece respirator is worn when deactivating, decontaminating and cleaning underneath the work surface of a C-PEC, when cleaning up a spill, when there is risk of splashes to the face and eyes and when unpacking suspected damaged drugs? *Note: In this case, an N95 or N100 NIOSH-approved mask offers no protection from vapours, and gases and splashes.
43	Compounding personnel wear clean room scrubs, not street clothes?
44	Cleaning equipment for cleaning areas used for the compounding of hazardous sterile preparation is specifically designated for this area?
45	Housekeeping personnel also don two pairs of ASTM International gloves, with the outer gloves being sterile?
46	Daily cleaning, decontamination and disinfecting is occurring for the following areas: C-PEC, counters, carts, floors, and surfaces that are touched frequently such as chairs) in hazardous drug compounding areas?
47	The minimum frequency of surface decontamination, deactivation, and disinfection inside the C-PEC are occurring? (see table 8, in NAPRA)
48	The maximum syringe fill limit is 75% or ¾ of the total syringe capacity when withdrawing hazardous drugs?
49	The verification of hazardous drug compounding is through direct observation or image capture? (proxy or syringe-pull back methods are NOT used)
50	Two pairs of ASTM International approved gloves are donned when unpacking intact hazardous products that have been received from the supplier sealed in impervious plastic?
51	All PPE worn for hazardous drug handling is discarded in a hazardous waste container?
52	The level of hazardous drug contamination is measured at least every 6 months (wipe sampling program)?
53	Compounding personnel wear an N95 respirator when compounding hazardous drugs in a BSC?
54	Spill kits are available in locations where hazardous products are handled and are present on carts used for transporting hazardous products.
55	Personnel involved in the delivery of hazardous products receive training on the transport and delivery procedures, including the procedure for dealing with accidental exposure or spills.
56	Cleaning equipment for cleaning areas used for the compounding of hazardous sterile preparation is specifically designated for this area?
57	Two pairs of ASTM International approved gloves are donned when unpacking intact hazardous products that have been received from the supplier sealed in impervious plastic?
58	If a pass-through is not equipped with an interlocking system that prevents both doors from being open at the same time, a procedure has been implemented whereby only one door is open at a time?
59	Work surfaces and furniture used in the anteroom and cleanroom ARE constructed of smooth, impervious, non-friable and non-porous materials?
60	The pharmacy has procedures in place to prevent personnel with rashes, sunburn, open sores, conjunctivitis and other infections from preparing sterile compounds?
61	Single dose vials that have been punctured in the PEC ARE discarded after 6 hours? (This includes pharmacy bulk vials that do not contain preservative)
62	Finished compounded sterile preparations are inspected for container closure integrity? (leakage etc.)
63	Transportation of sterile preparations to the patient location prevents damage and maintains appropriate temperatures during transit?
64	A policy is established for the labelling of compounded sterile preparations according to provincial /federal legislation?
65	The pharmacy has policies and procedures for the compounding hazardous sterile preparations? (list of suggested P&Ps can be found in Appendix 1 of the NAPRA Model Standards for Hazardous Sterile Preparations).