| 1 | 2- General Requirements | - The primary establishment did not ensure that sperm or ova were processed in accordance with the Regulations prior to distributing or making use of them.
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| 2 | 5- Registration | - The establishment’s application for registration did not include some required information.
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| 3 | 18- Notification | - The establishment did not notify Health Canada before distributing or importing sperm or ova.
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| 4 | 33- Directed Donation Process | - The establishment did not always perform a physical exam on the directed donors in accordance with the Directive.
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| 5 | 34- Directed Donation Process | - The establishment did not use appropriate and effective tests for infectious disease testing set out in the Directive.
- The establishment did not always perform all required testing on the directed donors in accordance with the Directive.
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| 6 | 36- Directed Donation Process | - The primary establishment did not ensure that the medical director created or signed a summary document for directed donations.
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| 7 | 40- Directed Donation Process | - A health professional, in the context of a directed donation, did not create a document stating that, in their medical opinion, the use of sperm or ova would not pose a serious risk to human health and safety.
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| 8 | 43- Quality Management System | - The establishment’s document control or records management system was not sufficient.
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| 9 | 44- Quality Management System | - Some processes were not described in standard operating procedures.
- The individual responsible for the quality management system did not approve the standard operating procedures.
- Some standard operating procedures were not kept up to date.
- Not all standard operating procedures were reviewed every two years.
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| 10 | 45- Quality Management System | - The establishment did not carry out an internal audit every two years of the activities that it conducts to ensure that the activities comply with the Regulations and with its standard operating procedures.
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| 11 | 46- Tracing and Identifying | - The establishment’s system for tracing sperm and ova was not sufficient.
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| 12 | 51- Labelling and Storing | - The establishment did not establish and maintain shipping standards.
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| 13 | 53- 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.
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| 14 | 57- Personnel, Facilities, Equipment and Supplies | - The establishment did not ensure that some critical equipment was validated, calibrated, cleaned or maintained as required.
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| 15 | 58- Personnel, Facilities, Equipment and Supplies | - The expiry dates of critical supplies were not always observed.
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| 16 | 67- Errors and Accidents | - The establishment or health professional did not send to Health Canada a preliminary report within 72 hours after the start of investigations.
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| 17 | 78- Records | - The establishment did not always keep all records containing records of the qualifications, training and competency of its employees for 10 years.
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| 18 | 84- Records | - Records were not always complete.
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| 19 | 85- Records | - The records were stored in a location that was not secure against the entry of unauthorized persons.
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