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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
Generation Fertility (KW) Inc. 536B7293 2024-12-03 Regular Inspection Compliant

Summary of observations

Observation number Regulation Summary of observation
134- Directed Donation Process
  • The establishment did not always perform all required testing on the donor.
236- Directed Donation Process
  • The summary document confirming the directed donation did not always include all required information.
  • The primary establishment did not always ensure that the medical director created or signed a summary document for directed donations.
338- 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.
444- Quality Management System
  • Some standard operating procedures were not kept up to date.
  • Some processes were not described in standard operating procedures.
532- 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.
633- Directed Donation Process
  • The physical exam was not always conducted by the Medical Director, or a physician or nurse practitioner designated by the Medical Director.
740- Directed Donation Process
  • The communication of risk, in the context of a directed donation, was not always sufficient.
843- Quality Management System
  • Some standard operating procedures were not always followed.
945- Quality Management System
  • The establishment’s internal audit system did not meet some of the requirements.
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 stored under proper environmental conditions.
  • The expiry dates of critical supplies were not always observed.
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

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