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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
Atlantic Assisted Reproductive Therapies (AART) BE375F52 2024-10-08 Regular Inspection Compliant

Summary of observations

Observation number Regulation Summary of observation
134- Directed Donation Process
  • The establishment did not always use appropriate and effective tests for infectious disease testing set out in the Directive.
257- Personnel, Facilities, Equipment and Supplies
  • The establishment did not ensure that some critical equipment was validated, calibrated, cleaned or maintained as required.
358- Personnel, Facilities, Equipment and Supplies
  • The expiry dates of critical supplies were not always observed.
432- Directed Donation Process
  • The establishment did not always perform donor screening for directed donors in accordance with the requirements set out in the Directive.
527- Donor Suitability Assessment
  • A primary establishment did not ensure that its medical director’s determination of a donor’s suitability was based on a review of all of the information obtained from the donor suitability assessment.
636- Directed Donation Process
  • The summary document confirming the directed donation did not always include all required information.
743- Quality Management System
  • Some standard operating procedures were not always followed.
  • The establishment’s document control or records management system was not sufficient.
844- Quality Management System
  • Some standard operating procedures were not kept up to date.
945- Quality Management System
  • The establishment’s internal audit system did not meet some of the requirements.
1053- 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.
1184- 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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