Infection Prevention & Control (IPAC) Investigations

1. Inadequate storage of single-use devices (SUD)
2. Inadequate reprocessing of reusable equipment and reprocessing of SUD files.

3. Reprocessing area had no one-way flow to prevent cross contamination. Unrelated items were stored in the re-processing area.
4. No Process Challenge Device (PCD) used to test sterilizer.
5. Incomplete quality assurance and documentation for ultrasonic cleaning device.
6. No plumbed eyewash station on site.

• Owner to remove re-usable endodontic files, replace with SUDs where possible and following MIFUs.
• Ensure one-work flow in reprocessing area
• PCD in use
• Instruments are disassembled prior to reprocessing

• Clinic complied with HPPA Sec 13 verbal Order on date of Order
• As of July 11, 2025 Clinic using a SUDs endodontic instruments

1. Observed adequate storage of single-use devices (SUD).
2. Re-usable endodontic files were observed replaced with single use.
3. Designated reprocessing area has one-way flow to prevent cross contamination, and all unrelated items were properly stored.
4. Process Challenge Device (PDC) observed to be in use to test sterilizer and Biological Indicators (BI) properly documented and maintained.
5. Quality assurance and documentation for ultrasonic cleaning device are completed and maintained.
6. Plumbed eyewash station observed on-site.

• Reusable nail equipment not clean and disinfected or sterilized between each use.
• Fail to ensure reprocessing sink not located in room with toilet.
• Fail to ensure sink sufficiently separate from where personal services provided.
• Fail to ensure every product used is stored and dispensed in a manner which prevents contamination.
• Fail to ensure disinfectants used are accompanied by a health Canada drug identification number or natural product number.
• Fail to ensure disinfectants used for reprocessing are not expired.
• Fail to ensure personal service setting free from condition that may adversely affect sanitary operation.
• Fail to maintain client records.

• Stop providing NAILS service immediately until Toronto Public Health has authorized you to resume providing service.
• Ensure reprocessing sink is installed in the premises, not in room with toilet, and allows for dirty to clean workflow.
• Ensure all cleaning and disinfectant products are not expired and are Health Canada approved.
• Reprocess multi-use nail tools by cleaning with soap (detergent) and water and then disinfecting with the appropriate disinfectant. Store items in a sanitary manner.
• Finish construction of back half of premises, ensure floors, walls and ceilings are in good repair and sanitary manner before opening.

• Complaint from a member of the public received on August 8, 2025.
• On-site re-inspection to be conducted.

• Inadequate reprocessing
• No reprocessing quality assurance records on site.

• Re-processing steps and use of disinfectants reviewed and corrected on October 11, 2024.
• Owner replacing re-usable instruments with single-use devices (SUDs) where possible.

October 11, 2024, MIFU for disinfectants reviewed with Dr. Park.

• Individual patient notification recommended for patients who received the following procedures at the clinic between October 10, 2020, and October 10, 2024

• 1. Endocervical polyp excision
  2. Endometrial biopsy
  3. Intrauterine Device (IUD) insertion/removal

• Toronto Public Health’s assessment is based on observations and information provided during the investigation.
• Individuals who did not receive a letter but may have had the above-noted procedure(s) before October 2020 or had a different procedure (includes pap testing) during the time of interest (October 2020-October 2024) may also consider testing in discussion with their health care provider.

The investigation results were posted on TPH’s IPAC disclosure webpage, as per the OPHS and TPH procedure. Patients who had undergone higher-risk procedures (based on the IPAC lapse and risk of infectious disease transmission, i.e., intrauterine contraceptive device (IUD) insertion / removal, endocervical polyp excision, or endometrial biopsy) between October 10, 2020, to October 10, 2024, were sent letters via direct mail to consult with their health care provider about testing for bloodborne infections. Other patients, who underwent lower-risk procedures based on risk of infectious disease transmission between October 2020 to October 2024, and patients who underwent procedures (high and/or low risk) outside of the notification window of October 10, 2020, to October 10, 2024, requested advice from TPH about testing. These patients were advised that they may wish to consider testing for bloodborne infections in discussion with their health care provider.

In total, as of August 31, 2025, approximately 2,600 letters were sent via direct mail to patients of the clinic who had undergone high risk procedures during the notification window. TPH received test results for 622 patients. No cases of bloodborne diseases were confirmed to have been the result of exposure at the clinic. No cases with HIV or active hepatitis C infections were detected in the results reported. Nine patients were identified with hepatitis B infection; however, following public health investigation, all were classified as previously known cases with acquisition sources not related to the clinic.

Although the public health risk of bloodborne disease transmission is very low, TPH still recommends bloodborne disease testing for individuals who underwent higher-risk procedures (as listed above) between October 10, 2020, and October 10, 2024, and who have not yet been tested and/or have not yet discussed the matter with their health care provider. All other patients who had procedures during the notification window (i.e., pap smears or vaginal examination with a speculum, pessary fitting, treatment of genital warts, word catheter insertion / removal, vulvar tag excision) or any procedure prior to October 10, 2020, may also wish to consider bloodborne disease testing in consultation with their health care provider.

• Inadequate sterilization processes, including deficiencies in quality assurance (QA): Improper cleaning and disinfection of brushes and labeling of sterilization packages.
• Lack of quality assurance for high-level disinfectants with over dilution of product.
• Failure to properly clean and disinfect transvaginal ultrasound probes.

• Stop providing healthcare services that require use of multi-use instruments and/or instruments that are/have been reprocessed using the current sterilizer at the clinic.
• Stop all procedures using the transvaginal ultrasound probes.

• Clinic replaced re-usable medical instruments with single-use devices (SUDs).
• Clinic stopped performing any procedures using the transvaginal ultrasound probes.

• Switch to single-use devices.
• No longer performing transvaginal ultrasound (TVUS) services.

• Reprocessing area did not have one-way flow.
• Process Challenge Device (PCD) was not used to test sterilizer.
• Chemical product used for additional step in cleaning was not prepared and used according to the Manufacturer’s Instructions for Use (MIFU).
• Reprocessed dental instruments not stored in a manner to prevent contamination.

• Ensure one-work flow in reprocessing area
• PCD in use
• Removed chemical disinfectant without expiry date
• Reprocessed dental instruments stored in a manner that keeps them clean, dry and prevents contamination.

• Eun Jun (Ann) Kim, RPN
  O/A Ann Kim Nursing Foot Care
  Richmond Hill, ON (Mobile Foot Care)
• Humber Meadows Long Term Care Home
  2109 Finch Ave West, North York, ON M3N 0A6
• Fountain View Care Community
  1800 O’Conner Drive, Building 2, North York, ON M4A 1W7
• Weston Terrance Community
  2005 Lawrence Ave West, York, ON M9N 3V4
• Rockcliffe Care Community
  3015 Lawrence Ave East, Scarborough, ON M1P 2V7

TPH was notified by a family member of a patient living in Humber Meadows Long Term Care Home regarding a potential foot fungus from contractor. Contractor provides services to other Longterm Care Homes.

Investigation was completed by York Region Public Health (YRPH) due to the location of the practitioner’s reprocessing:

• Inadequate cleaning practices: Devices not pre-cleaned promptly, unsuitable detergents used
• Improper device use: Single-use foot care devices were reprocessed and reused but not during the same day / visit
• Non-compliant sterilization: Unapproved equipment used; monitoring and documentation of sterilization not performed per IPAC standards

Please see YRPH IPAC lapses disclosure website for more information.

• Develop and implement policies outlining contractor expectations and auditing processes
• Ensure contracted service providers adhere to current IPAC standards and best practice
• Review and ensure appropriate cleaning and reprocessing of equipment used for services
• Increase surveillance of patients that were involved monitoring for foot infections

Intravenous medication administration error; reuse of syringe to access IV; error was noted immediately.

• The MSH IPAC team completed an investigation, reviewed the processes, completed a root cause analysis and implemented recommendations from the root cause analysis.
• MSH completed an extensive chart review to identify the potential for medication handling errors in the unit since opening in January 2023; as a precaution, MSH is conducting individual patient notification for any patients who may have been affected.
• Inspection completed; no IPAC issues were observed; compliance with best practices observed with respect to medication handling and administration.

• Inadequate reprocessing of endoscopes as per manufacturer’s instructions.
• Inadequate monitoring and record keeping for high-level disinfectant.
• Improper reprocessing of semi-critical instruments.
• Inadequate monitoring and record keeping for autoclave.
• Improper handling / use of multi-dose vials.

• HPPA Section 13 Order provided to stop use of the autoclave onsite, until further notice by TPH.
• Clinic to reprocess all semi-critical instruments prior to re-use as per manufacturer’s instructions.
• Clinic to maintain adequate record keeping and monitoring logs for high-level disinfectant.
• Clinic to dispose of all open and unlabelled multi-dose vials.
• Clinic to designate staff member for reprocessing and to provide adequate training.
• Clinic to clear reprocessing room of unused appliances and increase counterspace to facilitate one-way flow from dirty to clean.

• Semi-critical instruments were sterilized without packaging and not maintained sterile until point of use.
• No biological indicators for sterilizer prior to April 2025.

• Instruments reprocessed in the sterilizer are to be packaged as per best practice guidelines and sterility of instruments to be maintained until point of use.
• Alternatively, clinic may use single use disposable equipment.

• Clinic complied with order and is currently using a combination of disposable equipment as well as reprocessing equipment in the sterilizer using best practice.

• Clinic has implemented the recommendations provided by TPH.
• Clinic continues to follow best practices for sterilization of equipment, including proper packaging, maintaining sterility until point of use, performing biological indicator (BI) checks and completing required documentation.

• Fail to ensure biological testing of sterilizer is conducted at least once every two weeks to ensure adequate sterilization to destroy microorganisms.
• Fail to ensure all sterile pouches used for the items sterilized at the premises are equipped with minimum type 4 internal chemical indicators.
• Fail to ensure documenting load numbers and content information in the mechanical/physical records of the sterilized items at the premises.
• Fail to ensure reprocessing jewellery before reinsertion and sterilize clamps in open positions.
• Fail to ensure the sterilizer used for sterilizing piercing items and jewelry is inspected by a Public Health Inspector prior to start using the sterilizer.
• Fail to document the lot number and expiry dates of commercially purchased pre-packaged and sterile single-use items.

• Stop using the G42000 Statim sterilizer immediately until the sterilizer passes 3 consecutive spore tests conducted by an accredited laboratory, and Toronto Public Health has authorized to resume the use of the sterilizer.
• Immediately open all packages of instruments, items, and jewelry that were sterilized at the premises.
• Use only commercially purchased pre-packaged and sterile single-use items until Toronto Public Health has authorized you to resume the use of the sterilizer.
• Ensure at minimum type 4 internal chemical indicators are used in the sterile pouches used for all the items sterilized at the premises.
• Ensure documenting load numbers and content information in the mechanical/physical records of the sterilized items at the premises and document as per the sample sterilization log form provided.
• Ensure to reprocess jewelery before reinsertion and sterilize clamps in open positions.
• Ensure to document the lot number and expiry dates of commercially purchased pre-packaged and sterile single-use items.

• Re-inspections were conducted on November 20 and 21, 2025.
• Infection prevention and control best practices education, and resources were provided.
• November 21, 2025, sterilizer biological spore tests passed results.

December 9, 2025

April 8, 2025 TPH visited the clinic to find/be informed of:

1. Informed of use of expired biological (BI) and chemical indicators (CI) for sterilizer quality assurance (QA).
2. Informed of wet reprocessed packages were removed from sterilizer.
3. Observed incomplete QA logs for sterilizer and ultrasonic device, and no maintenance logs.
4. Observed dental instruments incorrectly reprocessed in assembled and/or closed position
5. Sterilizer model not currently approved by Health Canada on review in April 2025.

1. Ensure QA indicators (biological and/or chemical indicators) are within expiry dates.
2. Ensure QA log for sterilization is maintained and includes the following: process date, load control label, physical parameters, load contents, person responsible for load, CI results, and BI results.
3. Ensure Manufacturer’s Instructions for Use (MIFU) for sterilizer are followed.
4. Ensure to remove reprocessed (sterilized) packages from sterilizer after cycle is complete.
5. Ensure reprocessed packages are dry and stored to protect from contamination.
6. Maintain and document a maintenance schedule and for the sterilizer and ultrasonic device.
7. Ensure to reprocess dental instruments as per MIFU in their open and disassembled position.
8. Obtain a Health Canada approved sterilizer that meets Provincial Best Practice Document and CSA requirements.

1. Corrected: Biological (BI) and chemical indicators (CI) within expiry date for sterilizer quality assurance (QA).
2. Corrected: Sterilizer model is currently approved by Health Canada.

1. Reprocess all dental instruments in open position or disassembled as per Public Health Ontario.
2. Complete QA logs for sterilizer and ultrasonic device, and provide maintenance logs.

1. Reprocessed dental instruments in open position or disassembled.
2. Completed (QA) logs for sterilizer and ultrasonic machine.

• Failure to manage sterile items in a manner to differentiate sterile from non-sterile items
• Inadequate sterilization process, including quality assurance and 1-way flow of processes
• Utilization of expired chemicals, sharps, and medication
• Failure to maintain a dedicated reprocessing room
• Failure to maintain hand hygiene items at point of use
• Reprocessing and re-use of single use devices
• Inadequate education and training of staff performing reprocessing

• Stop use of ‘the current sterilizer’ Ritter M7 Speed Clave Sterilizer for reprocessing instruments, and use of any items that have been reprocessed in this current sterilizer, until Toronto Public Health (TPH) has authorized you to resume providing service(s).
• Stop providing healthcare services that require use of multi-use instruments and/or instruments that are/have been reprocessed using the current sterilizer immediately until TPH has authorized you to resume providing service(s).
• Remove all instruments from sterilizer packaging and hold instruments to be reprocessed in a dedicated area, until TPH has authorized you to resume reprocessing and reprocess all items according to Provincial Best Practices for Sterilization.
• Affix a sign to the current sterilizer to say “not to be used”, immediately until TPH has authorized you to resume providing service(s).
• Perform 3 consecutive biological indicator tests (inside a process challenge device) on the current sterilizer and report results to TPH.
• Obtain ABHR, liquid soap, and paper towel in order to perform hand hygiene before and after providing care to a patient, and other points according to Provincial Best Practices
• Review and remove any and all expired chemicals, products, medications, cleaners, sharps, etc., that are outside of their expiry dates
• Stop re-use and/or reprocessing of any instruments that are labelled and/or intended as Single Use Devices
• Ensure that the reprocessing room is dedicated to only reprocessing, and has a 1-way flow of device management
• Stop providing any and all healthcare procedure in the reprocessing room
• Deliver service(s) using acceptable infection prevention and control practices as detailed above as corrective action required

• Fail to ensure biological testing of sterilizer is conducted at least once every two weeks to ensure adequate sterilization to destroy microorganisms.
• Fail to ensure appropriate records for the sterilizer are maintained.
• Fail to ensure sterilizer is maintained in a sanitary condition.
• Fail to ensure multi use body piercing items are reprocessed as required.
• Fail to ensure reprocessing sink and premises is maintained in a sanitary condition.
• Fail to ensure open, used needle tattoo cartridges are disposed of immediately after use in sharps container near where the personal service is provided.
• Fail to remove full sharps container from the service area.
• Fail to discard single-use equipment immediately after use.
• Fail to ensure skin antiseptic is Health Canada approved with a drug identification number or natural product number.
• Fail to maintain body piercing items in a sterile manner.
• Fail to maintain single-use sterile tattoo items in a sanitary condition and used before the expiry date.
• Fail to ensure disinfectant product is not expired.
• Fail to ensure hand soap in the dispenser is near the handwashing sink.

• Immediately stop using the sterilizer until 3 consecutive spore tests are conducted and passed and authorized by Toronto Public Health to resume the use of the sterilizer.
• Do not use any multi-use piercing related items until authorized by Toronto Public Health.
• Use only commercially purchased pre-packaged and sterile single-use items.
• Discard immediately unapproved skin antiseptic from the premises.
• Immediately remove all commercially purchased prepackaged sterile single use tattoo related items stored in an unsanitary condition and expired from the premises.
• Discard the expired disinfect.
• Clean and disinfect the reprocessing sink and surrounding area.
• Reprocess tattoo items and maintain the premises in a sanitary condition.
• Discard used and open sharps into the approved sharps container.
• Remove the full sharps container from the service area.
• Discard used single-use dispensers.
• Move the soap in the dispenser next to the handwashing sink.

• Inspection was conducted on October 15, 2025 and verbal order issued on October 15, 2025.
• Re-inspection conducted on October 17, 2025 and verbal order issued on October 17, 2025.

• Reinspection was conducted. The G42000 sterilizer along with reusable piercing tools and items have been removed from the premises.
• For piercing, the premises only uses single use commercially purchased prepackaged sterile jewellery and piercing tools and items that are in piercing cabinets and are separated from the open jewellery in the premises’ display retail cabinet.
• All previous infractions were corrected.