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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
Heartland Fertility Clinic A4533748 2024-11-19 Regular Inspection Compliant

Summary of observations

Observation number Regulation Summary of observation
143- 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 did not meet the requirements.
244- Quality Management System
  • Some standard operating procedures were not kept up to date.
  • Some processes were not described in standard operating procedures.
329- Quarantine
  • There was no documentation to indicate that the health professional noted their assessment of risk of using the sperm or ova, and that there were no serious risks to human health and safety in using.
  • There was no document indicating the health professional obtained written informed consent from the recipient.
432- Directed Donation Process
  • The establishment’s structured donor screening questionnaire for directed donors did not include some criteria outlined in the directive.
543- Quality Management System
  • Some standard operating procedures were not always followed.
645- Quality Management System
  • The establishment’s internal audit system did not meet some of the requirements.
753- 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.
857- Personnel, Facilities, Equipment and Supplies
  • The establishment did not ensure that some critical equipment was validated, calibrated, cleaned or maintained as required.
958- Personnel, Facilities, Equipment and Supplies
  • The expiry dates of critical supplies were not always observed.
  • Critical supplies were not always stored under proper environmental conditions.
1084- 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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