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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
Grace Fertility and Reproductive Medicine Inc (GFRM) (a.k.a. "Grace Fertility Centre") 231909A9 2024-09-17 Regular Inspection Non-Compliant

Summary of observations

Observation number Regulation Summary of observation
15- Registration
  • The primary establishment did not list the name and address for some establishments conducting processing activities on their behalf.
223- Donor Suitability Assessment
  • The establishment did not always perform donor screening in accordance with the requirements set out in the Directive.
  • The establishment’s structured donor screening questionnaire(s) did not include some criteria outlined in the Directive.
332- Directed Donation Process
  • The establishment did not always perform donor screening for directed donors in accordance with the requirements set out in the Directive.
  • The establishment’s structured donor screening questionnaire for directed donors did not include some criteria outlined in the directive.
436- Directed Donation Process
  • The summary document confirming the directed donation did not always include all required information.
540- Directed Donation Process
  • A health professional, in the context of a directed donation, did not always 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.
  • A health professional, in the context of a directed donation, did not always 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.
644- Quality Management System
  • Some standard operating procedures were not kept up to date.
757- Personnel, Facilities, Equipment and Supplies
  • The establishment did not ensure that some critical equipment was validated, calibrated, cleaned or maintained as required.
859- Errors and Accidents
  • The establishment’s system to identify, investigate and/or report errors and accidents was not sufficient.
938- Directed Donation Process
  • In the context of a directed donation, the establishment did not ensure that the medical director of the primary establishment reviewed the donor suitability assessment and if applicable, donor reassessment, prior to release.
1043- Quality Management System
  • The establishment’s document control or records management system was not sufficient.
1143- Quality Management System
  • Some standard operating procedures were not always followed.
1244- Quality Management System
  • Some processes were not described in standard operating procedures.
1345- Quality Management System
  • The establishment’s internal audit system did not meet some of the requirements.
1453- 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.
1584- Records
  • The establishment’s records were not always accurate, complete, legible and/or indelible.

Inspection outcome

The inspection resulted in a non-compliant rating. The establishment was not 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 not conducting the regulated activities in compliance with the Safety of Sperm and Ova Regulations.

Measures taken by Health Canada

  • We requested corrective actions and may conduct a re-inspection.
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