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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
Omega Fertility Center 1579AD44 2024-04-23 Regular Inspection Compliant

Summary of observations

Observation number Regulation Summary of observation
143- Quality Management System
  • The establishment did not have standard operating procedures for some of the activities that it conducts.
  • Some standard operating procedures were not always followed.
244- Quality Management System
  • Some standard operating procedures were not kept up to date.
  • Not all standard operating procedures were in a standard format
345- Quality Management System
  • The establishment did not carry out an internal audit every two years of the activities that it conducts to ensure that the activities comply with the Regulations and with its standard operating procedures.
453- 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.
557- Personnel, Facilities, Equipment and Supplies
  • The establishment did not ensure that some critical equipment was validated, calibrated, cleaned or maintained as required.
658- Personnel, Facilities, Equipment and Supplies
  • The expiry dates of critical supplies were not always observed.
767- 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.
884- 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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