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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
Anova Fertility & Reproductive Health Inc. 42113696 2024-09-24 Regular Inspection Compliant

Summary of observations

Observation number Regulation Summary of observation
138- Directed Donation Process
  • In the context of a directed donation, the establishment did not quarantine sperm or ova until the medical director of the primary establishment responsible for the quarantine determined and documented that sperm and ova can be released from quarantine.
244- Quality Management System
  • Some processes were not described in standard operating procedures.
  • Some standard operating procedures were not kept up to date.
  • The standard operating procedures were not in a standardized format.
311- 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.
432- Directed Donation Process
  • The establishment’s structured donor screening questionnaire for directed donors did not include some criteria outlined in the directive.
540- Directed Donation Process
  • 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.
  • 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.
643- Quality Management System
  • The establishment did not have standard operating procedures for some of the activities that it conducts.
  • The establishment’s document control or records management system was not sufficient.
744- Quality Management System
  • Not all standard operating procedures were reviewed every two years.
853- 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.
957- Personnel, Facilities, Equipment and Supplies
  • The establishment did not ensure that some critical equipment was validated, calibrated, cleaned or maintained as required.
1058- Personnel, Facilities, Equipment and Supplies
  • The expiry dates of critical supplies were not always observed.
  • Critical supplies were not always stored under proper environmental conditions.
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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