Infection Prevention & Control (IPAC) Investigations

1. No quality assurance reprocessing logs for the “sterilizer”
2. No reprocessing quality assurance with Biological Indicators or a minimum of Class 4 Chemical Indicator strips
3. The “sterilizer” was not challenged using a Process Challenge Device
4. No dedicated reprocessing area; all reprocessing actions were performed in a patient exam room used for patient exams
5. The “sterilizer” is kept in a patient recovery room
6. Sterilized packages were not labelled as per best practices
7. Speculums were reprocessed unpackaged and thereafter being stored without packaging in drawers
8. No regular maintenance on the “sterilizer”; no manufacturer’s instructions for use (MIFU) noted on site
9. No training on reprocessing and IPAC recorded for staff
10. No IPAC or occupational health Policies and Procedures (P&P’s) available
11. No documentation/log of COVID-19 screening including taking and recording of body temperature
12. Multi-use ultra-sound gel tubes are being used
13. Vitamins for patients stored in open shelving in hallways
14. No emergency eye-wash station noted in the clinic (This is a Ministry of Labour requirement)
15. Un-used equipment and furniture stored in the clinic
16. Patient exam table has cracked upholstery,
17. Biohazardous waste freezer is not labelled,
18. No handwashing signs posted at sinks
19. No Safety Data Sheets available onsite for products being used at the clinic
20. Unpackaged Single-Use speculums noted in drawer
21. Bleach and water mixture of unknown strength used for presoaking used instruments.
22. Incorrect use of face mask which was not covering the nose
23. Improper storage of sterile instruments, and
24. Inadequate pre-cleaning and cleaning of multi-use instrument

1. Surfaces, furnishings, equipment, and finishes are smooth, non-porous, seamless (where possible), and cleanable (e.g., no unfinished wood or cloth furnishings). Re-upholster the patient exam table in the patient exam room where the upholstery is cracked and open,
2. Place signage on each fridge/freezer indicating the use: e. “staff fridge,” “medication fridge”, and “biohazardous waste”
3. Multi-dose ultrasound gel tubes are to be replaced with single use doses of ultrasound gel
4. Post handwashing signs at each sink,
5. Single-use items are to be stored in its original packaging or stored in a closed/covered storage space such as a closed cupboard or drawer
6. Medications/vitamins are to be stored in a closed cupboard in a space that is not easily accessible to patients and visitors
7. Develop a policy and procedure for handling of blood and body fluids. This includes blood specimens obtained through venipuncture (e.g., platelet rich plasma for bone grafts) and biopsy specimens
8. Develop written policies and procedures to prevent and manage injuries from sharp objects
9. Develop procedures for cleaning each area of the setting; if cleaning is contracted out, ensure the cleaning contractor has procedures in place for cleaning each area of the setting
10. Develop written procedure for immediate containment, cleaning, and disinfection of spills of blood and body fluids
11. Develop a policy to prevent the transmission of blood-borne pathogens (i.e., hepatitis B, hepatitis C and HIV) that includes a staff immunization policy for hepatitis B vaccination and a record of documented immunity to hepatitis B by serology
12. Develop blood-borne pathogen post-exposure management policy and procedure that incorporates staff worker education and facilitation of timely access to a medical assessment for appropriate post-exposure prophylaxis (PEP), if indicated (e.g., HIV PEP medications)
13. Develop a policy, which includes a clear expectation that staff do not come into work when ill with symptoms of infection
14. Staff members are immunized as recommended by the National Advisory Committee on Immunization (NACI). Keep a record for each staff and update annually,
15. Develop a binder/file for Safety Data Sheets (SDS) for cleaning/disinfecting products being used at the clinic and ensure that the SDS are readily available and up to date
16. Install eyewash station that meet Ministry of Labour (MOL) requirement
17. Develop a policy that specifies the requirements for, and frequency of, education and training at regular intervals (e.g., orientation and continuing education), as well as competency assessment for all personnel involved in IPAC practices
18. Develop a process for recording and reporting of attendance at staff education and training sessions
19. All employees must complete “Public Health Ontario IPAC Core Competencies” course, and renew it annually. Keep a log of the names and dates
20. As the clinic will be no longer reprocessing multiuse items, please ensure the following:
    1. Remove the “sterilizer” from this clinic once it has been challenged with BI and CI as directed by TPH and results have been reported
    2. Remove all reprocessing instruments and materials used during reprocessing i.e. sterilization pouches etc., from the clinic
    3. Remove all multi-use instruments from the clinic
    4. Develop written policy stating that clinic is to only use Single-Use Devices(SUDs), and
    5. Ensure appropriate supply of SUDs are available at the clinic

1. Stop using the sterilizer, Pelton & Crane Validator 8 model AB (“sterilizer”), onsite at 200-1371 Neilson Road, Toronto, Ontario, M1B 4Z8, and,
2. Stop using instruments that were reprocessed in this “sterilizer”, at this clinic or any other clinic

• Patient notification conducted.
• Policy and procedures to be developed.

• No reprocessing logs on site for the sterilizer or the ultrasonic cleaner
• No Biological Indicator (BI) or Chemical indicator (CI) or Process Challenge Device (PCD) used in the sterilizer
• No dedicated reprocessing area
• Sterilized packages were not labelled appropriately
• Re-use and reprocessing of single-use devices (SUDs) such as skin biopsy/punch instruments
• No IPAC/occupational health policies and procedures on site
• No training on reprocessing/IPAC provided to staff
• No COVID-19 screening
• Opened multi-dose vials not labelled properly
• Expired medication and products on site
• Inappropriate storage of sterile medical supplies
• No eye-wash station
• Cloth chairs in the examination room and the clinic waiting area

1. Complete three consecutive Biological Indicator (BI) tests on the sterilizer on site.
2. Monitor sterilizer appropriately and maintain logs. If sterilizer no longer used, to remove off site.
3. Obtain manufacturing instructions for sterilizer and ultrasonic cleaner on site.
4. Only reprocess multi-use instruments.
5. Discard single-use items immediately after use.
6. Where possible only use single-use vials and discard all opened vials.
7. If using multi-dose vials, label appropriately when opened.
8. Ensure there is a policy/procedure for the following:

• • General IPAC and Routine Practices (including use of Personal Protective Equipment, “PPE”);
  • General Occupational Health and Safety (including management of body fluid spills, staff immunizations, and staff exposure to chemicals/sharps );
  • Sharps Management (including use of Safety Engineered Needles);
  • Reprocessing (including quality assurance for reprocessing, packaging for sterilizing, and/or use of Single Use Devices);
  • Environmental Cleaning (including supplies storage, and management of chemicals); and
  • Initial and ongoing IPAC training for staff.

9. Consult with Ministry of Labour regarding eyewash station.
10. Ensure all staff members are trained in infection prevention and control (IPAC) as well as reprocessing procedures.
11. Discard all expired medications, items, and products (lotions) from the clinic.
12. Ensure all medications, instruments, and supplies items are stored in a manner to prevent contamination.
13. Ensure paper towels are mounted at each sink.
14. Ensure a sharps container is mounted at each point of use.

1. Stop using the sterilizer for reprocessing instruments located at 600 Sherbourne Street East, Unit 411, Toronto, Ontario M4X 1W4; and
2. Do not use the reprocessed instruments.

• Sterilizer onsite was used without Biological Indicators (BI) or Chemical Indicators (CI).
• No sterilizer logs maintained.
• No ultrasonic machine for cleaning instruments prior to sterilization.
• Two patient exam tables had upholstery held together with tape.
• All garbage cans onsite were open, without a lid.
• Non safety-engineered needles in a box on top of the counter at the vaccine fridge.
• Self-contained single use bags were not observed in the soap containers. All liquid hand soap containers are topped up.
• No Occupational Health and Safety information/binders.
• No written policy or procedures about IPAC and health and safety.
• No eye wash station

• Complete three separate Biological Indicator (BI) tests in the sterilizer onsite.
• Remove the sterilizer from the clinic site.
• Remove all re-usable instruments from the clinic site.
• Only Single Use Disposable (SUD) Medical equipment/devices are to be used at this clinic.
• Surfaces, furnishings, equipment and finishes are smooth, non-porous, seamless (where possible), and cleanable.  Patient exam tables that have taped upholstery are to be re-upholstered.
• Liquid hand soap containers are labelled and not refilled or topped up.
• Needles are safety engineered medical sharps (SEMS).
• Safety Data Sheets (SDS) for cleaning/disinfecting products are readily available and up to date for staff reference.
• All garbage cans are to have covered lids.
• An eyewash station is to be within a  10 second walk from where chemical substances will be used/managed
• All staff are to complete IPAC core competencies course annually

1. Stop using the sterilizer for reprocessing instruments located at 48 Sheppard Ave West office.
2. Open any reprocessed instruments.
3. Do not use the reprocessed instruments.

Stopped use of the sterilizer, and sterilizer has been removed from the clinic site.

All re-usable instruments have been opened and removed from the clinic site.

Only Single Use Disposable (SUD) Medical equipment/devices are being used.

Patient exam tables have been re-upholstered.

One time use, labelled, disposable liquid hand soap containers are being used.

Needles are safety engineered medical sharps (SEMS).

Safety Data Sheets (SDS) for cleaning/disinfecting products are available and up to date for staff reference.

All garbage cans have covered lids.

An eyewash plumbed station is to be within a 10 second walk from where chemical substances will be used/managed has been put in place.

• inadequate reprocessing of multi-use medical instruments
• inadequate quality assurance and documentation for reprocessing
• inappropriate workflow in reprocessing area
• staff not trained for reprocessing activities
• no sharps management policy/procedure

• Immediately stop using the sterilizer and all services requiring multi-use instruments until permitted by Toronto Public Health (TPH) to resume.
• Open reprocessed items and do not reprocess until permitted by TPH.
• Record reprocessing activities in a  log book Reprocessing area to only be used for reprocessing, designated a reprocessing area and be appropriately organized, meeting the standards of a reprocessing area (e.g. clear flow from dirty to clean).
• Staff to be trained on reprocessing.
• Reprocessing policy and procedures to be readily available, and in the reprocessing area.
• Sharps management policy and procedure to be available and staff to be trained on this policy and procedure.

1. Clinic is challenging the sterilizer appropriately.
2. All multi-use items were sterilized properly.
3. There is a separate reprocessing area which has clear workflow from dirty to clean.
4. Staff was trained formally on reprocessing activities.
5. There is an appropriate sharps management policy and procedure.

• use of unsterilized instruments on eight dental patients
• inadequate quality assurance and documentation for reprocessing

• remove two unused sterilizers from premises
• open and reprocess all multi-use items
• maintain appropriate logs of the sterilizer for each cycle including physical indicators, chemical indicators and biological indicators
• maintain an appropriate log for the ultrasonic process and keep this documentation separate from the sterilization process log
• all staff trained and frequently review reprocessing policy and procedures
• all clinic staff to annually complete the online IPAC core competencies course available on the Public Health Ontario website
• all clinic staff with reprocessing duties including the dentists to complete online IPAC reprocessing course available on the Public Health Ontario website

• notification of eight exposed patients by Toronto Public Health to complete baseline testing for HBV, HCV, and HIV, and get assessed for post-exposure prophylaxis

• Directions provided during onsite inspection on November 18, 2020.
• Letter of recommendation emailed November 23, 2020.

• Two unused sterilizers removed from premises.
• New log created for the sterilizer.
• New and separate log created for the autoclave.
• Designated process challenge device (PCD) used for every load.
• Written policies and procedures that are an umbrella statement referring to Public Health Ontario (PHO) Best Practices documents.
• All staff to begin the PHO Core Competency course; to be completed and logged for six-month re-inspection review by Toronto Public Health (TPH).
• All staff completing reprocessing duties to begin PHO Reprocessing in the community course; to be completed and logged for six-month re-inspection review by TPH.

• inadequate reprocessing of semi-critical and critical instruments
• inadequate one-way flow in the reprocessing area
• inadequate re-qualification of sterilizers
• inadequate storage of clean and sterilized instruments

Items to be addressed include:

1. Ensure all semi-critical instruments are reprocessed as per manufacturer’s instructions for use (MIFUs), including quality assurance and its documentation.
2. Perform sterilizer re-qualification for each sterilizer on-site and each cycle used as per MIFU.
3. Ensure there is one-way flow from dirty to clean in the reprocessing room. This was corrected during inspection.
4. Ensure hinged instruments are reprocessed in open and unlocked positions.
5. Ensure clean and sterilized instruments are stored securely in a manner that prevents contamination. This was corrected during inspection.

Stop performing Immediate Use Steam Sterilization (also known as Flash Sterilization).

• noted that intravenous (IV) tubing for catscan (CT) contrast procedure was inappropriately set-up
• possible that a section of single-use CT contrast tubing was not discarded immediately after use and that there may have been re-use of this section of tubing

• Ensure single-use CT contrast tubing is discarded immediately after each use.

• On-site visits conducted.
• Ensure strict monitoring of trainees and new staff to ensure adherence to policies and procedures.
• Ensure clear assignment of staff, and documentation of procedures.

• inadequate reprocessing of semi-critical instruments
• inadequate management of multi-dose vials

Items to be addressed include:

1. Ensure all semi-critical instruments are reprocessed as per manufacturer’s instructions for use (MIFUs), including quality assurance and its documentation required related to high-level disinfection.
2. Ensure there is one-way flow from clean to dirty in the reprocessing room.
3. Dispose of open multi-dose vials according to MIFU.
4. Make available appropriate personal protective equipment (PPE).
5. Create Infection Prevention and Control (IPAC) policies/procedures based on current provincial best practices.
6. Educate all staff on updated IPAC policies/procedures and reprocessing.