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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
Dr. Clifford Librach Medicine Professional Corporation 0CACDE4A 2023-02-06 Regular Inspection Compliant

Summary of observations

Observation number Regulation Summary of observation
12- General Requirements
  • The primary establishment did not ensure that establishments conducting processing activities on their behalf were doing so in accordance with the Regulations.
243- Quality Management System
  • The establishment’s document control or records management system was not sufficient.
344- Quality Management System
  • The individual responsible for the quality management system did not approve all changes to the standard operating procedures before they were implemented.
458- Personnel, Facilities, Equipment and Supplies
  • The expiry dates of critical supplies were not always observed.
559- Errors and Accidents
  • The establishment did not establish and maintain a system that allows for the identification, investigation and reporting of all error and accidents.
623- Donor Suitability Assessment
  • The establishment’s structured donor screening questionnaire(s) did not include some criteria outlined in the Directive.
733- Directed Donation Process
  • The establishment did not always perform the physical examination within the required timeline(s).
834- Directed Donation Process
  • The establishment did not always perform some donor testing within the timeframe(s) set out in the Directive.
936- Directed Donation Process
  • The summary document confirming the directed donation did not always include all required information.
1043- Quality Management System
  • Some standard operating procedures were not always followed.
1144- Quality Management System
  • The standard operating procedures did not meet some of the requirements.
1251- Labelling and Storing
  • The establishment did not always ensure that the documentation that accompanied the immediate containers included all the required information in English or French.
1353- 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.
1455- 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.
1557- Personnel, Facilities, Equipment and Supplies
  • The establishment’s system for the cleaning and maintenance of its critical equipment did not always meet the requirements.
1667- 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.
1784- 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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