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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 2024-01-29 Regular Inspection Non-Compliant

Summary of observations

Observation number Regulation Summary of observation
127- Donor Suitability Assessment
  • The primary establishment determined a donor to be suitable even when the donor met criteria that would exclude them from donating.
22- General Requirements
  • The primary establishment did not ensure that establishments conducting processing activities on their behalf were doing so in accordance with the Regulations.
322- Donor Suitability Assessment
  • The donor suitability assessment was not always complete or accurate.
431- Directed Donation Process
  • The donor suitability assessment was not always complete or accurate for directed donors.
540- 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.
643- Quality Management System
  • The establishment’s document control or records management system was not sufficient.
  • Some standard operating procedures were not always followed.
744- Quality Management System
  • The standard operating procedures did not meet some of the requirements.
  • The standard operating procedures were not in a standardized format.
811- Changes or Cessation
  • The primary establishment did not notify Health Canada in writing within 30 days of a change in the information on its registration application.
927- Donor Suitability Assessment
  • The summary document confirming the donor suitability did not always include some required information.
1036- Directed Donation Process
  • The summary document confirming the directed donation did not always include all required information.
1145- Quality Management System
  • The establishment’s internal audit system did not meet some of the requirements.
1251- Labelling and Storing
  • The establishment did not always verify the integrity of the immediate containers and the shipping containers.
1353- 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.
1457- Personnel, Facilities, Equipment and Supplies
  • The establishment’s system for the cleaning and maintenance of its critical equipment did not always meet the requirements.
1558- Personnel, Facilities, Equipment and Supplies
  • Critical supplies were not always stored under proper environmental conditions.
1684- Records
  • The establishment’s records were not always accurate, complete, legible and/or indelible.

Inspection outcome

The inspection resulted in a non-compliant rating. The establishment was not 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 not 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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