Pharmacy – Sterile Compounding Areas

Environmental Services/ Nutrition Food Services Operating Standards Manual

Number: 3.1.4.5

Date Approved June 17, 2016

Approved by: Corporate Director, Environmental Supports

Date Effective June 28, 2016

Next Review June 17, 2019

Purpose This Operating Standard provides guidance for the expectations of appropriate steps for cleaning and disinfecting pharmacy sterile compounding areas (clean room and ante area), including hazardous ‘clean’ areas.

Applicability This Operating Standard applies to all Covenant Health Environmental Services employees and all Covenant Health Pharmacy employees. Compliance with this protocol is required for any other persons acting on behalf of Covenant Health including contracted service providers as applicable.

Responsibility All Environmental Services employees, Covenant Health Pharmacy employees, and contracted service providers acting on behalf of Covenant Health Pharmacy are required to follow the steps outlined when cleaning and disinfecting pharmacy sterile compounding areas, including hazardous ‘clean’ areas.

Principles

A standard cleaning and disinfecting process for pharmacy sterile compounding areas ensures disinfection of the environment where sterile compounding occurs in the Pharmacy area as well as hazardous ‘clean’ areas.

Procedures

TOOLS NEEDED Cleaning tools; cleaning equipment is to be stored in a dedicated storage area in the pharmacy, preferably in the ante area.

a. Dedicated cleaning equipment must be assigned and labeled for each sterile compounding area, including hazardous ‘clean’ areas to prevent cross-contamination.

b. Disposable cleaning supplies are required. All cleaning equipment must be disinfected prior to being taken into the sterile compounding area. Documentation shall be completed on the daily and monthly EVS cleaning log.

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SAFETY PRACTICES 1. Place floor sign where it is readily seen at all entrances and exits of

the area and remove when floors are dried. Carry garbage bags away from body. Follow proper ergonomic practices as per training. Change Personal Protective Equipment (PPE) as necessary to prevent cross contamination. If there are any questions regarding safe practices, please consult with your immediate supervisor.

2. Correct PPE is to be donned according to pharmacy policy and procedures prior to entering the clean room, Pharmacy will supply: hair covers, facial hear covering (as required), shoe covers, surgical masks, gown, and sterile gloves.

3. Disposable cleaning supplies used in the hazardous ‘clean’ areas are to be disposed of as cytotoxic waste.

4. Pharmacy hand hygiene steps must be followed. Refer to Appendix A.

5. Staff must use only sterile gloves to clean in Sterile Compounding Areas.

6. Following cleaning in hazardous ‘clean’ areas, disposable gloves, booties, head cover and mask are to be disposed of into cytotoxic waste container.

7. Cleaning schedules/processes should be discussed and arranged with the Pharmacy supervisor in advance. No cleaning or garbage removal is to be done while pharmacy staff are working (i.e. compounding medication) in the Sterile Compounding Areas.

8. Sharps containers are puncture-resistant, not puncture-proof. This may present a risk of sharps injury.

STEPS

1. Perform hand hygiene. Collect all supplies and equipment needed to clean the area. 2. Put on (don) appropriate PPE to prepare cleaning/disinfectant products as per the

Safety Data Sheets (SDS) for product. 3. All cleaning equipment must be disinfected prior to being taken into the sterile

compounding area. 4. Remove (doff) PPE. 5. Place clean wet floor sign at all entrances/exits of sterile compounding area. 6. Perform hand hygiene as per Pharmacy Hand Hygiene procedure (Appendix A). Don

appropriate PPE as per Pharmacy requirement (Appendix B). 7. High dust all areas with a damp cloth, including ledges, ceilings, lights, vents, cubicle,

walls and miscellaneous objects. Static dusters are not permitted. 8. Spot clean walls. Complete wall washing will be done as per Cleaning Frequency

Standard. Damp wipe pass-through. 9. Damp wipe doors, door handles, frames, kick plates, and hinges. 10. Damp wipe horizontal surfaces, work stations, window ledges, and spot wash

windows. Do not touch personal or paper items. EVS staff shall not clean any of the

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inside or outside surfaces of the hoods and biological safety cabinets. These will be cleaned by Pharmacy staff.

11. Damp wipe all wall fixtures, light fixtures, light switches, dispensers. Clean internal surfaces of the dispensers.

12. Damp wipe counter tops and surfaces around and behind office equipment. Computer keyboards and monitors are cleaned by Pharmacy staff.

13. Damp wipe tables, table legs, shelves, chairs, movable carts. Ensure chair legs, castors and wheels are damp wiped.

14. Damp wipe telephones. 15. Damp wipe floor pedals and pumps. 16. Check sharps container. Change when filled to the ¾ full lines. Ensure container is

sealed shut prior to disposal. Where containers are mounted on the wall, wipe the brackets of the sharps container if not at ¾ full line.

17. Clean and disinfect hand hygiene sinks. 18. Damp wipe waste container inside and outside. Let dry thoroughly. Pharmacy staff

removes the garbage bag daily prior to cleaning by EVS staff. 19. Damp mop baseboards and floors. Damp mop floor using concept of far corner to

door. Pay particular attention to corners, edges, and baseboards. Mop heads for damp mopping must not be double-dipped in any cleaning solution. Disposable mop heads will be disposed of outside the sterile compounding area. Mop heads used to clean hazardous ‘clean’ areas are to be disposed of in cytotoxic waste containers prior to leaving the area.

20. Doff gloves and perform hand hygiene (Avagard®) and don new gloves as per Pharmacy requirements.

21. Replenish dispenser supplies and reline waste container. Do not top up refillable containers.

22. Remove wet floor sign when floor is dry. 23. Doff PPE. Perform hand hygiene. For hazardous ‘clean’ areas, dispose of PPE in

cytotoxic waste container.

Footnotes: Order of Cleaning: All items/areas MUST be cleaned from the cleanest item/area to the dirtiest item/area and from high to low. Mop head and water – MUST BE CHANGED every three rooms, or before if visibly soiled. *Exception: Mop head and water MUST BE CHANGED every room for isolation cleans. Microfiber Mop heads – MUST BE CHANGED every room, or before if visibly soiled. Double dipping – Soiled cloth must not be re-dipped into /disinfecting solution(s). Soiled clothes must be discarded into soiled linen bags on carts immediately after use. Cloths and rags MUST be changed frequently within each patient environment in order to prevent cross contamination. Maintenance – report plugged or damaged toilets, urinals, sinks/fixtures, lights, walls, etc. to unit staff and to your Supervisor or submit maintenance requisition where appropriate. Cleaning/Disinfecting Products – Never mix chemicals. Review SDS sheets for product handling and precautions. Product(s) must be measured properly and changed after every case. Chemical must remain

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on surface for entire kill cycle / contact time. Refer to specific chemical directions. Ensure proper solution concentration testing Standard Operating Procedures are followed and documented. Use only hospital approved cleaning and disinfecting products. If at any time you are unsure of which tool(s) and/or product(s) to use for a task, consult your Supervisor. Personal Protective Equipment (PPE) – Clothing or equipment worn by staff for protection against hazards. To “Don” is to put on, and to “Doff” is to remove. Additional Precautions (AP) – Precautions (i.e. Contact Precautions, Droplet Precautions, Airborne Precautions) that are necessary in addition to Routine Practices for certain pathogens or clinical presentations. These precautions are based on the method of transmission (e.g. contact, droplet, airborne). Damp Cloth – Cloth must be wet to ensure that the surface stays wet for the required contact time of a disinfectant to be effective. Cleaning – The physical removal of foreign material (e.g. dust, soil) and organic material (e.g. blood, secretions, excretions, microorganisms). Cleaning physically removes rather than kills microorganisms. It is accomplished with water, detergents and mechanical action. Disinfection – The inactivation of disease-producing microorganisms. Disinfection does not destroy bacterial spores. Medical equipment/devices must be cleaned thoroughly before effective disinfection can take place. Hazard Assessment – Health and Safety Hazard Assessments mitigate the risk of incident/injury or illness from exposure to biological, chemical, or physical contaminants. To reduce the risk of incident/injury or illness appropriate controls must be put into place. Health and Safety Hazard Assessments must be completed and reviewed before an ES employee is exposed to contaminants which may pose incident/injury or illness. This is done to protect the health and safety of ES employee, other staff and patients/residents. Employee Incident/Injury Reporting – Report incidents or unsafe work to your Supervisor and/or to OHS through the incident management process as required. Risk Assessment – Assessment conducted before each interaction with a patient/resident or their environment to determine the risk of exposure to infectious agents, and the appropriate interventions (additional precautions, PPE etc.) to reduce the risk of transmission. Two-Step Clean – A two-step process is used to clean and then disinfect surfaces. First wipe surfaces thoroughly to clean the surfaces of visible organic material (dirt you can see) and then wipe again with a clean cloth saturated with disinfectant to remove invisible microorganisms (things you cannot see). Organic materials that are not properly removed during the first step may inactivate the disinfectant used in the second step, therefore both steps are essential. Cleaning Frequency – Based on the Cleaning Frequency Standard. Hazardous ‘Clean’ Areas – Dedicated areas where hazardous drugs are prepared (i.e. chemotherapy, biological agents, and radiopharmaceuticals).

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Line of Demarcation - A physical line on the floor that separates the clean area and dirty area. Clean room – A room in which the concentration of airborne particles is controlled to meet specified airborne particulate cleanliness class. Microorganisms in the environment are monitored so the microbial level for air, surface, and personal gear are not exceeded for a specific cleanliness class. Anteroom or Ante area: A room outside the clean room in which activities such as hand washing, gowning, and gloving are performed to prepare of admittance to the clean room. This room may be referred to as the ‘Scrub Room’. Sterile Compounding Areas – the area of the pharmacy or the controlled area or room defined as ‘and area or space where the only activities taking place are those related to the compounding of sterile preparations. The area includes both the cleanroom and anteroom or ante area. Hazardous Drug – A drug for which research on humans or animals has shown that any exposure to the substance has the potential to cause cancer, lead to a developmental or reproductive toxicity or damage organs. (NAPRA – Model Standard for Pharmacy Compounding of Hazardous Sterile Preparations, Draft 2A- August 2014). References 1. Alberta Health Services, Linen and Environmental Services,

Cleaning Protocol Standard # ES-PROT-CLN-056 2. National Association of Pharmacy Regulatory Authorities.

Model Standards for Pharmacy Compounding of Non-hazardous Sterile Preparations. Draft 4. November 2015

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Appendix A

Aseptic Handwash Procedure Avagard® Waterless Hand Antiseptic

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Appendix B

Donning & Doffing Personal Protective Equipment (PPE) Non-Hazardous Sterile Compounding

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Appendix C

How to Don Sterile Gloves