Monarch Dentistry KGR IPAC Lapse Report

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Initial Report

Establishment under investigation (name and address)	Monarch Dentistry 265 King George Rd. Brantford, Ontario N3R 6Y1
Establishment type	Dental clinic
Date health unit became aware of potential IPAC lapse	December 1, 2020
Date of initial report posting	March 1, 2021
Date of initial report update(s) (if applicable)
How was the IPAC lapse identified?	Referral from another health unit as part of a multi-jurisdictional investigation
Date of on-site investigation	December 7, 2020

IPAC Lapse Investigation

Did the IPAC lapse involve a member of a regulatory college?	Yes; Royal College of Dental Surgeons of Ontario
If yes, was the issue referred to the regulatory college?	Yes
Were corrective actions recommended and/or implemented?	Yes
Date of any order(s) or directive(s) issued to the owner/operator (if applicable)	December 7, 2020
Summary description of the IPAC lapse	During the inspection, it was observed that the cleaning, disinfection and sterilization of reusable instruments on site did not follow Provincial Infectious Disease Advisory Committee (PIDAC) Best Practices for Cleaning, Disinfection and Sterilization of Medical Equipment/Devices (May, 2013). The reprocessing work area is physically separated from other work areas, however, the design does not allow for a one-way flow of instruments from dirty to clean to prevent cross-contamination. At time of the investigation, instrument/equipment manufacturer’s instructions for use (MIFU’s) were not available for review. Incorrect packaging of instruments prior to sterilization (e.g., instruments observed to be in a closed position; instruments were not properly packaged to allow steam to move around and through the item(s) and contact all surfaces). Insufficient quality assurance monitoring for sterilization (e.g., load contents not documented, sterilization parameters not verified as per MIFU, initials of processor observed missing). 6. Sterilized packages were observed to be wet at time of the investigation and placed in a drawer to dry.
Additional comments and/or updates to initial report	Staff members responsible for any or all steps in reprocessing are recommended to complete the Medical Device Reprocessing Techniques Online Course through the Medical Device Reprocessing Association of Ontario. Office closed voluntarily by owner.

Final Report

Brief description of corrective measures taken	Manufacturer’s instructions are currently being used for all instruments. Instruments where manufacturer’s instructions were not found have been removed from the dental clinic. Reusable equipment were reprocessed as per manufacturer’s instructions. Instruments were repackaged appropriately to allow steam to penetrate through the item(s) and contact all surfaces. Clinic implemented sufficient quality assurance for the monitoring of sterilization (e.g., labels on sterilized packs had all the required information). Sterilization pouches containing instruments were observed to be dry following sterilization.
Date all corrective measures were confirmed to have been completed	February 23, 2021
Date of final report posting and/or any date of any updates to final posting	March 1, 2021
Date of follow-up to confirm corrective actions taken and completed	February 9, 2021
Additional comments	Staff members responsible for any or all steps in reprocessing are recommended to complete the Medical Device Reprocessing Techniques Online Course through the Medical Device Reprocessing Association of Ontario.