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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
Clinique Conceptia Inc. 4B73853A 2024-06-11 Regular Inspection Compliant

Summary of observations

Observation number Regulation Summary of observation
131- Directed Donation Process
  • The donor suitability assessment was not complete or accurate for directed donors.
244- Quality Management System
  • The standard operating procedures did not meet some of the requirements.
358- 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.
418- Notification
  • The information in the establishment’s notification for distribution or importation was not accurate.
529- Quarantine
  • There was no document indicating the health professional obtained written informed consent from the recipient.
632- Directed Donation Process
  • The establishment’s structured donor screening questionnaire for directed donors did not include some criteria outlined in the directive.
736- Directed Donation Process
  • The summary document confirming the directed donation did not always include all required information.
843- Quality Management System
  • The establishment’s document control or records management system did not meet the requirements.
945- Quality Management System
  • The establishment’s internal audit system did not meet some of the requirements.
1051- Labelling and Storing
  • The establishment did not always verify the integrity of the immediate containers or the shipping containers before shipping.
1157- Personnel, Facilities, Equipment and Supplies
  • The establishment did not ensure that some critical equipment was validated, calibrated, cleaned or maintained as required.
1259- Errors and Accidents
  • The establishment’s system for error and accidents did not always meet all of the requirements.

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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