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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
Markham Fertility Centre Inc. 5D9B9376 2022-07-11 Regular Inspection Compliant

Summary of observations

Observation number Regulation Summary of observation
124- Donor Suitability Assessment
  • The establishment did not always perform the required physical examination on the donors.
225- Donor Suitability Assessment
  • The establishment did not perform donor testing in accordance with the requirements set out in the Directive.
333- Directed Donation Process
  • The establishment did not always perform a physical exam on the directed donors in accordance with the Directive.
434- Directed Donation Process
  • The establishment did not always perform all required testing on the directed donors in accordance with the Directive.
55- Registration
  • The primary establishment did not list the name and address for some establishments conducting processing activities on their behalf.
628- Quarantine
  • The establishment did not always quarantine all sperm and ova until the medical director of the primary establishment responsible for the quarantine determined the donor was suitable.
732- Directed Donation Process
  • The establishment’s structured donor screening questionnaire for directed donors did not include some criteria outlined in the directive.
838- Directed Donation Process
  • In the context of a directed donation, the establishment did not quarantine sperm or ova until the medical director of the primary establishment responsible for the quarantine determined and documented that sperm and ova can be released from quarantine.
943- Quality Management System
  • The establishment did not have standard operating procedures for some of the activities that it conducts.
  • The establishment’s document control or records management system was not sufficient.
1044- Quality Management System
  • Not all standard operating procedures were in a standard format
1144- Quality Management System
  • Some processes were not described in standard operating procedures.
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.
1359- Errors and Accidents
  • The establishment’s system for error and accidents did not meet some of the requirements.
1467- 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.
1569- Adverse Reactions
  • The establishment’s system for adverse reactions did not meet some requirements.
1684- 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

  • We requested corrective actions.
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