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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
Astra Fertility Group 3B8EF7EE 2024-07-16 Re-Assessment Compliant

Summary of observations

Observation number Regulation Summary of observation
123- Donor Suitability Assessment
  • The establishment’s structured donor screening questionnaire(s) did not include some criteria outlined in the Directive.
232- Directed Donation Process
  • The establishment’s structured donor screening questionnaire for directed donors did not include some criteria outlined in the directive.
336- Directed Donation Process
  • The summary document confirming the directed donation did not always include all required information.
440- 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.
543- Quality Management System
  • Some standard operating procedures were not always followed.
  • The establishment’s document control or records management system was not sufficient.
644- Quality Management System
  • Some processes were not described in standard operating procedures.
744- Quality Management System
  • Some standard operating procedures were not kept up to date.
  • Not all standard operating procedures were in a standard format
845- Quality Management System
  • The establishment did not carry out an internal audit every two years of the activities that it conducts to ensure that the activities comply with the Regulations and with its standard operating procedures.
953- 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.
1057- Personnel, Facilities, Equipment and Supplies
  • The establishment did not ensure that some critical equipment was validated, calibrated, cleaned or maintained as required.
1158- Personnel, Facilities, Equipment and Supplies
  • The expiry dates of critical supplies were not always observed.
1259- Errors and Accidents
  • The establishment’s system for error and accidents did not meet some of the requirements.
1384- 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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