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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
IVF Canada 1A7C0302 2024-02-27 Regular Inspection Compliant

Summary of observations

Observation number Regulation Summary of observation
127- Donor Suitability Assessment
  • The summary document confirming the donor suitability did not always include all required information.
234- Directed Donation Process
  • The establishment did not always perform some donor testing within the timeframe(s) set out in the Directive.
343- Quality Management System
  • The establishment did not have standard operating procedures for some of the activities that it conducts.
453- 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.
527- Donor Suitability Assessment
  • The determination of donor suitability was not completed by the Medical Director.
636- Directed Donation Process
  • The primary establishment did not ensure that the medical director created or signed a summary document for directed donations.
  • The summary document confirming the directed donation did not always include all required information.
744- Quality Management System
  • Some standard operating procedures were not kept up to date.
  • Not all standard operating procedures were in a standard format
857- Personnel, Facilities, Equipment and Supplies
  • The establishment did not ensure that some critical equipment was validated, calibrated, cleaned or maintained as required.
958- Personnel, Facilities, Equipment and Supplies
  • The expiry dates of critical supplies were not always observed.
1084- 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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