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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
TRIO Fertility CF6BD816 2023-06-19 Re-Assessment Compliant

Summary of observations

Observation number Regulation Summary of observation
144- Quality Management System
  • The standard operating procedures did not meet some of the requirements.
  • Not all standard operating procedures were in a standard format
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.
444- Quality Management System
  • Some standard operating procedures were not kept up to date.
  • Some processes were not described in standard operating procedures.
553- 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.
657- Personnel, Facilities, Equipment and Supplies
  • The establishment did not ensure that some critical equipment was validated, calibrated, cleaned or maintained as required.
767- Errors and Accidents
  • The establishment or health professional did not always send to Health Canada an interim report within 15 days after the start of investigations and every 15 days thereafter until the final report was made.
884- 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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