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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 2022-06-20 Regular Inspection Compliant

Summary of observations

Observation number Regulation Summary of observation
12- General Requirements
  • The primary establishment did not ensure that establishments conducting processing activities on their behalf were doing so in accordance with the Regulations.
223- Donor Suitability Assessment
  • The establishment’s structured donor screening questionnaire(s) did not include some criteria outlined in the Directive.
331- Directed Donation Process
  • The establishment did not always perform donor screening for directed donors in accordance with the requirements set out in the Directive.
434- Directed Donation Process
  • The establishment did not always perform all required testing on the directed donors in accordance with the Directive.
543- Quality Management System
  • The establishment’s quality management system did not meet some of the requirements of the Regulations.
  • 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.
861- Errors and Accidents
  • The establishment or health professional did not initiate an investigation into the suspected error or accident when they had reasonable grounds to believe that an error or accident had occurred during an activity they conducted.
95- Registration
  • The primary establishment did not list the name and address for some establishments conducting processing activities on their behalf.
1024- Donor Suitability Assessment
  • The establishment did not always perform the physical examination within the required timeline(s).
1133- Directed Donation Process
  • The establishment did not always perform a physical exam on the directed donors in accordance with the Directive.
1253- 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.
1357- Personnel, Facilities, Equipment and Supplies
  • The establishment did not ensure that some critical equipment was validated, calibrated, cleaned or maintained as required.
1458- Personnel, Facilities, Equipment and Supplies
  • The expiry dates of critical supplies were not always observed.
1559- Errors and Accidents
  • The establishment’s system for error and accidents did not meet some of the requirements.
1669- Adverse Reactions
  • The establishment’s system for adverse reactions did not meet some requirements.
1784- Records
  • Records were not always complete.
  • The information contained in the records was not always accurate, legible and 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 and may conduct a re-assessment.
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