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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
OVO Fertility Inc 3C8563B0 2021-09-13 Remote 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.
323- Donor Suitability Assessment
  • The establishment’s structured donor screening questionnaire(s) did not include some criteria outlined in the Directive.
425- Donor Suitability Assessment
  • The establishment did not perform some donor testing as required for the regular process.
529- Quarantine
  • There was no document indicating the health professional informed the recipient of the risks of the use of sperm or ova.
  • There was no document indicating the health professional obtained written informed consent from the recipient.
634- Directed Donation Process
  • The establishment did not perform some required testing for directed donors.
743- Quality Management System
  • The establishment did not have standard operating procedures for some of the activities that it conducts.
843- Quality Management System
  • The establishment’s document control or records management system was not sufficient.
98- Amendments
  • The primary establishment did not list the name and address for some establishments conducting processing activities on their behalf.
1027- Donor Suitability Assessment
  • The summary document confirming the donor suitability did not always include all required information.
1144- Quality Management System
  • The standard operating procedures did not meet some of the requirements.
  • The standard operating procedures were not kept up-to-date.
1251- Labelling and Storing
  • The establishment’s shipping standards were not sufficient.
1353- 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.
1457- Personnel, Facilities, Equipment and Supplies
  • The establishment did not ensure that some critical equipment was validated, calibrated, cleaned or maintained as required.
1558- Personnel, Facilities, Equipment and Supplies
  • Critical supplies were not always stored under proper environmental conditions.
1659- Errors and Accidents
  • The establishment’s system for error and accidents did not always meet all of the requirements.
1769- Adverse Reactions
  • The establishment’s system for adverse reactions did not meet some 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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