| 1 | 2- General Requirements | - The primary establishment did not ensure that establishments conducting processing activities on their behalf were doing so in accordance with the Regulations.
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| 2 | 18- Notification | - The establishment’s notification to Health Canada for distribution or importation of sperm or ova did not include all required information.
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| 3 | 34- Directed Donation Process | - The establishment did not perform some required testing for directed donors.
- The establishment did not always perform donor testing within the timeframe(s) set out in the Directive.
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| 4 | 36- Directed Donation Process | - The primary establishment did not always ensure that the medical director created or signed a summary document for directed donations.
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| 5 | 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.
- A health professional, in the context of a directed donation, did not create a document stating the recipient was informed of the risks that the use of the sperm or ova could pose to human health and safety.
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| 6 | 43- Quality Management System | - The establishment’s document control or records management system was not sufficient.
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| 7 | 43- Quality Management System | - The establishment did not have standard operating procedures for some of the activities that it conducts.
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| 8 | 44- Quality Management System | - The standard operating procedures did not meet some of the requirements.
- The standard operating procedures were not kept up-to-date.
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| 9 | 48- Tracing and Identifying | - The primary establishment did not assign a donation code to each donation of sperm and ova.
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| 10 | 52- Labelling and Storing | - The establishment did not always store sperm and ova at a temperature within the established acceptable storage temperature range.
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| 11 | 53- Personnel, Facilities, Equipment and Supplies | - The establishment did not have a program for the initial and ongoing training of some personnel and for evaluating their competency.
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| 12 | 58- Personnel, Facilities, Equipment and Supplies | - Critical supplies were not validated or qualified as applicable for their intended use.
- Critical supplies were not stored under proper environmental conditions.
- The expiry dates of critical supplies were not always observed.
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| 13 | 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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| 14 | 45- Quality Management System | - The establishment did not establish and maintain an internal audit system.
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| 15 | 54- Personnel, Facilities, Equipment and Supplies | - The establishment’s facilities did not have controlled access to some or all areas where activities were conducted.
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| 16 | 57- Personnel, Facilities, Equipment and Supplies | - The establishment did not ensure that all critical equipment was validated, calibrated, cleaned or maintained as required.
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| 17 | 70- Adverse Reactions | - The adverse reaction notice did not always contain the required information.
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| 18 | 84- Records | - The establishment’s records were not always accurate, complete, legible and/or indelible.
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