Monarch Dentistry KGR IPAC Lapse Report

Public Health Infection Prevention and Control Lapse Report

Patient Recall

Following the referral from another public health unit, the Brant County Health Unit identified an IPAC lapse at Monarch Dentistry located at 265 King George Rd, Brantford during their initial investigation on December 7, 2020.

During the initial investigation, improper sterilization requirements were not followed as per the Provincial Infectious Diseases Advisory Committee (PIDAC) best practice documents and the Canadian Standards Association (CSA). Improperly cleaned and improperly sterilized instruments can lead to the spread of bloodborne diseases such as hepatitis B, hepatitis C, and HIV. As a result of this lapse and possible exposure to blood-borne viruses, Brant County Health Unit is conducting a patient recall from October 28, 2016 to February 23 2021. The risk to an individual patient depends on the frequency and type of procedures that were performed.

Immediately following the inspection on December 7, 2020 the dental clinic voluntarily closed and the Brant County Health Unit provided the Monarch Dentistry clinic with a list of requirements for compliance as per the PIDAC documents and the CSA Standards. A follow-up inspection was conducted on February 9, 2021. After further investigation, the dental clinic provided new evidence to Brant County Health Unit on February 22, 2021 resulting in additional instruments being recalled from December 7, 2020 to February 23, 2021. The dental clinic was confirmed to be meeting the PIDAC best practice documents and the CSA standards on February 23, 2021.

The health unit has requested contact information for patients from the dental clinic about a potential risk for bloodborne diseases. There are no known associated cases of disease transmission at this time. Clients seen during this period will be sent an information package to notify and provide them with information about their next steps. Clients concerned about their health are encouraged to consult with their family physician. Clients or health care providers with questions or concerns regarding this exposure can call the Brant County Health Unit at 519-753-4937 at ext. 440.

Please refer to the following fact sheets for more information on bloodborne diseases:

Health Canada - Hepatitis B Fact Sheet
Health Canada - Hepatitis C Fact Sheet
Health Canada - HIV Fact Sheet

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.

Infectious Disease Team
519-753-4937 ext. 454
infectioncontrol@bchu.org

Reports

Public Health Infection Prevention and Control Lapse Report

Patient Recall

Initial Report

IPAC Lapse Investigation

Final Report