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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
The Montreal Fertility Centre 047F1187 2025-03-24 Re-Inspection Compliant

Summary of observations

Observation number Regulation Summary of observation
132- Directed Donation Process
  • The establishment’s structured donor screening questionnaire for directed donors did not include some criteria outlined in the directive.
238- Directed Donation Process
  • In the context of a directed donation, the establishment did not quarantine sperm or ova until the medical director of the primary establishment responsible for the quarantine determined and documented that sperm and ova can be released from quarantine.
343- Quality Management System
  • The establishment’s document control or records management system was not sufficient.
  • Some standard operating procedures were not always followed.
444- Quality Management System
  • The standard operating procedures did not meet some of the requirements.
  • Some standard operating procedures were not kept up to date.
518- Notification
  • The establishment did not notify Health Canada before distributing or importing sperm or ova.
629- Quarantine
  • There was no document indicating the health professional obtained written informed consent from the recipient.
753- Personnel, Facilities, Equipment and Supplies
  • The establishment’s program for the initial and ongoing training of some personnel and for evaluating their competency was not sufficient.
857- Personnel, Facilities, Equipment and Supplies
  • The establishment’s system for the cleaning and maintenance of its critical equipment did not always meet the requirements.
984- Records
  • The establishment’s records were not always accurate, complete, legible and/or indelible.

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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