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Donor sperm and ova inspections

Inspection report card summary

Initial inspection deficiencies report
Establishment name Reference number Inspection start date Inspection type Inspection rating
Centre de procréation assistée du CHU Sainte-Justine B86DE65B 2024-09-16 Regular Inspection Compliant

Summary of observations

Observation number Regulation Summary of observation
140- Directed Donation Process
  • A health professional, in the context of a directed donation, did not create a document stating that, in their medical opinion, the use of sperm or ova would not pose a serious risk to human health and safety.
  • A health professional, in the context of a directed donation, did not create a document stating the recipient was informed of the risks that the use of the sperm or ova could pose to human health and safety.
243- Quality Management System
  • The establishment’s quality management system did not meet some of the requirements of the Regulations.
336- Directed Donation Process
  • The summary document confirming the directed donation did not always include all required information.
445- Quality Management System
  • The establishment did not carry out an internal audit every two years of the activities that it conducts to ensure that the activities comply with the Regulations and with its standard operating procedures.
551- Labelling and Storing
  • The establishment did not always verify the integrity of the immediate containers and the shipping containers.
653- Personnel, Facilities, Equipment and Supplies
  • The establishment’s program for the initial and ongoing training of all personnel and for evaluating their competency was not sufficient.
757- Personnel, Facilities, Equipment and Supplies
  • The establishment did not ensure that some critical equipment was validated, calibrated, cleaned or maintained as required.
858- Personnel, Facilities, Equipment and Supplies
  • Critical supplies were not always validated or qualified as applicable for their intended use.
  • Critical supplies were not always stored under proper environmental conditions.
977- Records
  • The establishment or health professional did not always keep records that contained all the documents and information required under the Regulations.

Inspection outcome

The inspection resulted in a compliant rating. The establishment was compliant with the Safety of Sperm and Ova Regulations.

The rating is the result of observations made by Health Canada based on a reasonable belief at a particular point in time during the course of an inspection that the establishment was conducting the regulated activities in compliance with the Safety of Sperm and Ova Regulations.

Measures taken by Health Canada

  • We requested corrective actions.
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