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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
Anova Fertility & Reproductive Health Inc. 42113696 2022-03-21 Remote Inspection Compliant

Summary of observations

Observation number Regulation Summary of observation
123- Donor Suitability Assessment
  • The establishment’s structured donor screening questionnaire(s) did not include some criteria outlined in the Directive.
227- Donor Suitability Assessment
  • The determination of donor suitability was not always completed by the Medical Director.
336- Directed Donation Process
  • There was no documented evidence that the medical director always reviewed the information obtained from the donor suitability assessment for directed donation.
443- Quality Management System
  • The establishment’s quality management system did not meet some of the requirements of the Regulations.
  • The establishment’s document control or records management system was not sufficient.
544- Quality Management System
  • Some standard operating procedures were not kept up to date.
648- Tracing and Identifying
  • The primary establishment did not always assign a donation code to each donation of sperm and ova.
743- Quality Management System
  • Some standard operating procedures were not always followed.
844- Quality Management System
  • Some processes were not described in standard operating procedures.
953- 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.
1059- Errors and Accidents
  • The establishment’s system for error and accidents did not meet some of the requirements.
1169- Adverse Reactions
  • The establishment’s system for adverse reactions did not meet some requirements.
1284- Records
  • Records were not always complete.
  • The information contained in the records was not always accurate, legible and 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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