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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
Oasis Fertility Centre FEA0D41D 2022-03-07 Remote Inspection Compliant

Summary of observations

Observation number Regulation Summary of observation
132- Directed Donation Process
  • The establishment did not 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.
234- Directed Donation Process
  • The establishment did not always perform all required testing on the directed donors in accordance with the Directive.
336- Directed Donation Process
  • The primary establishment did not ensure that the medical director created or signed a summary document for directed donations.
444- Quality Management System
  • Not all standard operating procedures were in a standard format
544- Quality Management System
  • Some standard operating procedures were not kept up to date.
644- Quality Management System
  • Some processes were not described in standard operating procedures.
753- Personnel, Facilities, Equipment and Supplies
  • The establishment’s program for the initial and ongoing training of some personnel and for evaluating their competency was not sufficient.
857- Personnel, Facilities, Equipment and Supplies
  • The establishment did not ensure that some critical equipment was validated, calibrated, cleaned or maintained as required.
967- 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.

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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