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Donor sperm and ova inspections

Inspection report card summary

Establishment name Reference number Inspection start date Inspection type Inspection rating
Mount Sinai Fertility F32FF5DF 2023-02-06 Regular Inspection Compliant

Summary of observations

Observation number Regulation Summary of observation
132- Directed Donation Process
  • The establishment’s structured donor screening questionnaire for directed donors did not include some criteria outlined in the directive.
243- Quality Management System
  • Some standard operating procedures were not always followed.
  • The establishment’s document control or records management system was not sufficient.
344- Quality Management System
  • The standard operating procedures were not in a standardized format.
  • Some processes were not described in standard operating procedures.
444- Quality Management System
  • Some standard operating procedures were not kept up to date.
553- 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.
657- Personnel, Facilities, Equipment and Supplies
  • The establishment did not ensure that some critical equipment was validated, calibrated, cleaned or maintained as required.
758- Personnel, Facilities, Equipment and Supplies
  • The expiry dates of critical supplies were not always observed.
859- Errors and Accidents
  • The establishment’s system for error and accidents did not meet some of the requirements.
969- Adverse Reactions
  • The establishment’s system for adverse reactions did not meet some requirements.
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

  • We requested corrective actions.