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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
The Reproductive Care Centre A5743169 2022-11-14 Regular Inspection Compliant

Summary of observations

Observation number Regulation Summary of observation
134- Directed Donation Process
  • The establishment did not always perform all required testing on the directed donors in accordance with the Directive.
232- Directed Donation Process
  • The establishment did not always perform donor screening for directed donors in accordance with the requirements set out in the Directive.
  • The establishment’s structured donor screening questionnaire for directed donors did not include some criteria outlined in the directive.
343- Quality Management System
  • The establishment’s document control or records management system was not sufficient.
443- Quality Management System
  • Some standard operating procedures were not always followed.
544- Quality Management System
  • Some processes were not described in standard operating procedures.
644- Quality Management System
  • Some standard operating procedures were not kept up to date.
753- Personnel, Facilities, Equipment and Supplies
  • The establishment’s program for the initial and ongoing training of some personnel and for evaluating their competency was not sufficient.
855- Personnel, Facilities, Equipment and Supplies
  • The establishment did not establish and maintain a system for controlling and monitoring appropriate environmental conditions for some of the facilities and areas in which activities are conducted.
957- Personnel, Facilities, Equipment and Supplies
  • The establishment did not ensure that all critical equipment was validated, calibrated, cleaned or maintained as required.
1058- Personnel, Facilities, Equipment and Supplies
  • The expiry dates of critical supplies were not always observed.
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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