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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
McGill University Health Centre 4C531E94 2023-12-04 Regular Inspection Compliant

Summary of observations

Observation number Regulation Summary of observation
12- General Requirements
  • The primary establishment did not ensure that establishments conducting processing activities on their behalf were doing so in accordance with the Regulations.
231- Directed Donation Process
  • The donor suitability assessment was not always complete or accurate for directed donors.
332- Directed Donation Process
  • The establishment’s structured donor screening questionnaire for directed donors did not include some criteria outlined in the directive.
434- Directed Donation Process
  • The establishment did not perform some required testing for directed donors.
543- Quality Management System
  • The establishment’s document control or records management system was not sufficient.
644- Quality Management System
  • The standard operating procedures did not meet some of the requirements.
  • The standard operating procedures were not kept up-to-date.
753- 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.
833- Directed Donation Process
  • The establishment did not always perform a physical exam on the directed donors in accordance with the Directive.
945- Quality Management System
  • The establishment did not establish and maintain an internal audit system.
1058- Personnel, Facilities, Equipment and Supplies
  • Critical supplies were not stored under proper environmental conditions.
1157- Personnel, Facilities, Equipment and Supplies
  • The establishment’s system for the cleaning and maintenance of its critical equipment did not always meet the requirements.
1284- 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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