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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
KARMA IVF 536B7293 2021-06-07 Remote Inspection Compliant

Summary of observations

Observation number Regulation Summary of observation
132- Directed Donation Process
  • The establishment’s structured donor screening questionnaire for directed donors did not include some criteria outlined in the directive.
243- Quality Management System
  • The establishment’s document control or records management system was not sufficient.
344- Quality Management System
  • The standard operating procedures did not meet some of the requirements.
  • The standard operating procedures were not kept up-to-date.
443- Quality Management System
  • The establishment did not have standard operating procedures for some of the activities that it conducts.
519- Notification
  • The establishment did not notify Health Canada within 30 days of a change to the information provided in its notification.
643- Quality Management System
  • Some standard operating procedures were not always followed.
744- Quality Management System
  • Not all standard operating procedures were approved by the individual responsible for the quality management system.
853- 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.
959- Errors and Accidents
  • The establishment’s system for error and accidents did not meet some of the requirements.
1069- Adverse Reactions
  • The establishment’s system for adverse reactions did not meet some requirements.
1184- Records
  • The establishment’s records were not always accurate, complete, legible and/or indelible.

Inspection outcome

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.

The inspection resulted in a compliant rating. The establishment was compliant with the Safety of Sperm and Ova Regulations.

Measures taken by Health Canada

  • We requested corrective actions.
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