Request for information under subsection 12(2) of the General Nuclear Safety and Control Regulations

Directorate of Nuclear Substance Regulation

March 22, 2024

Martin Demers
Director, Multidisciplinary Services
Centre hospitalier de l’Université de Montréal
Montréal, QC
H2X 0A9

Subject: Request for information under subsection 12(2) of the General Nuclear Safety and Control Regulations

Dear Martin Demers:

Background

The CNSC conducted compliance inspections at CHUM between February 26 and March 1, 2024 [1,2]. These reactive inspections were carried out as a follow-up to the 2022 and 2023 inspections [3,5]. The CNSC increased the inspection frequency as part of its escalated enforcement approach since previous inspection results did not meet CNSC expectations [3-8]. Despite some improvements to the radiation protection program, the results of recent inspections show that CHUM continues to demonstrate significant non-compliance with regulatory requirements.

The CNSC requires licensees to demonstrate effective management support, including support of human and financial resources, to implement and maintain their radiation protection program. The inspection results and the program’s size and complexity caused the CNSC concern that insufficient resources have been allocated to CHUM’s radiation protection program. The CNSC voiced this concern in several previous inspection reports, as did the CHUM radiation protection committee and the radiation safety officer (RSO).

Request

Therefore, pursuant to my authority as a person designated by the Commission for the purposes of subsection 12(2) of the General Nuclear Safety and Control Regulations, I request CHUM to complete the following actions by May 17, 2024:

1. Conduct an analysis of the resources required to effectively implement the radiation protection program under the seven CNSC licences held by CHUM. This analysis will include, but not be limited to, the following components:
   1. An assessment of the time and tasks required to properly manage the radiation protection program,
   2. An analysis of the continuity of the radiation protection program in case of departure or absence of the RSO,
   3. A comparative analysis with other licensees with programs of similar scope and complexity, and
   4. An analysis of the additional resources required to implement corrective measures related to the non-compliance notices identified in inspection reports Type II Inspection Report - Cancer centre and DC-12527-LP-240229-1, and to verify the effectiveness of these measures.
2. Inform the CNSC of any actions taken or proposed in response to the results of the necessary analyses and assessments identified above.

Please note that, in accordance with subsection 12(2) of the General Nuclear Safety and Control Regulations, you are required to file a report by April 5, 2024, with the Commission including the following information:

3. Confirmation that the request will or will not be carried out or will be carried out in part;
4. Any action that CHUM has taken to carry out the request or any part of it;
5. Any reasons why the request or any part of it will not be carried out;
6. Any proposed alternative means to achieve the objectives of the request; and
7. Any proposed alternative period within which the licensee proposes to carry out the request.

Please submit your response to this request to Lindsay Pozihun, Inspector. If you have any questions, do not hesitate to contact her at 438-340-5188 or lindsay.pozihun@cnsc-ccsn.gc.ca.

Sincerely,

Claire Pike
Acting Director General

C. C. :

Frédérique Piché
John Thelen, CNSC
Nadia Petseva, CNSC
Sylvain Faille, CCSN
Lucie Simoneau, CNSC

References

1. Preliminary inspection report - Diagnostic and therapeutic nuclear medicine license, report index number DC-12527-LP-240229-1, March 1, 2024.
2. Type II Inspection Report - Cancer centre, March 1, 2024.
3. Type I Inspection Report - Cyclotron license, September 12, 2023.
4. Findings from the Type II inspection - Consolidated use license, report index number DCS-12527-DA-220901-1, September 1, 2022.
5. Type I Inspection Report - Cancer centre, April 1, 2022.
6. Findings from the Type II inspection - Diagnostic and therapeutic nuclear medicine license, report index number DC-12527-AN-220330-1, March 30, 2024.
7. Findings from the index number DC-12527-2374-181205-1 and D-12527-2374-181205-2, December 5, 2018.
8. Findings from the Type II inspection - Diagnostic and therapeutic nuclear medicine license, report index number DC-12527-1469-180404-1 and DC-12527-1469-180404-2, April 4, 2018.

June 19, 2024

The licensee has responded to the request for information to the satisfaction of CNSC staff.