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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
Aurora Fertility Centre Inc. 61E2B24B 2022-10-03 Regular Inspection Compliant

Summary of observations

Observation number Regulation Summary of observation
134- Directed Donation Process
  • The establishment did not always perform donor testing within the timeframe(s) set out in the Directive.
  • The establishment did not always use appropriate and effective tests for infectious disease testing set out in the Guidance Document.
211- 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.
318- Notification
  • The establishment did not notify Health Canada before distributing or importing sperm or ova.
432- Directed Donation Process
  • The establishment’s structured donor screening questionnaire for directed donors did not include some criteria outlined in the directive.
535- Directed Donation Process
  • The primary establishment did not always ensure that a repeat directed donor was reassessed in accordance with the Directive.
636- Directed Donation Process
  • The primary establishment did not always ensure that the medical director created or signed a summary document for directed donations.
743- Quality Management System
  • Some standard operating procedures were not always followed.
  • The establishment did not have standard operating procedures for some of the activities that it conducts.
844- Quality Management System
  • Some standard operating procedures were not kept up to date.
  • The standard operating procedures were not in a standardized format.
953- 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.
1067- Errors and Accidents
  • The establishment or health professional did not send to Health Canada a preliminary report within 72 hours after the start of investigations.
1184- 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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