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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
Victory Reproductive Care 6D3BE612 2022-03-07 Remote 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.
232- Directed Donation Process
  • The establishment’s structured donor screening questionnaire for directed donors did not include some criteria outlined in the directive.
334- Directed Donation Process
  • The establishment did not always perform all required testing on the directed donors in accordance with the Directive.
436- Directed Donation Process
  • The summary document confirming the directed donation did not always include all required information.
543- Quality Management System
  • The establishment’s quality management system did not meet the requirements of the Regulations.
644- Quality Management System
  • The standard operating procedures did not meet some of the requirements.
744- Quality Management System
  • Some processes were not described in standard operating procedures.
867- Errors and Accidents
  • The establishment or health professional did not submit reports to the Minister for an investigation it conducted into a suspected error or accident that could lead to an adverse reaction.
943- Quality Management System
  • The establishment did not have standard operating procedures for some of the activities that it conducts.
1053- 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.
1157- Personnel, Facilities, Equipment and Supplies
  • The establishment did not ensure that some critical equipment was validated, calibrated, cleaned or maintained as required.
1258- Personnel, Facilities, Equipment and Supplies
  • Critical supplies were not always validated or qualified as applicable for their intended use.
1359- Errors and Accidents
  • The establishment’s system for error and accidents did not meet some of the requirements.
1469- Adverse Reactions
  • The establishment’s system for adverse reactions did not meet some requirements.

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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