| 1 | 32- Directed Donation Process | - The establishment did not always perform donor screening for directed donors in accordance with the requirements set out in the Directive.
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| 2 | 34- Directed Donation Process | - The establishment did not always perform infectious disease testing in accordance with the requirements set out in the Directive.
- The establishment did not perform some required testing for directed donors.
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| 3 | 43- 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 did not meet the requirements.
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| 4 | 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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| 5 | 58- Personnel, Facilities, Equipment and Supplies | - The expiry dates of critical supplies were not always observed.
- Critical supplies were not always validated or qualified as applicable for their intended use.
- Critical supplies were not stored under proper environmental conditions.
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| 6 | 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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| 7 | 32- Directed Donation Process | - The establishment’s structured donor screening questionnaire for directed donors did not include some criteria outlined in the directive.
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| 8 | 35- Directed Donation Process | - The primary establishment did not ensure that a repeat directed donor was reassessed in accordance with the Directive.
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| 9 | 36- Directed Donation Process | - The summary document confirming the directed donation did not always include all required information.
- The primary establishment did not always ensure that the medical director created or signed a summary document for directed donations.
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| 10 | 40- Directed Donation Process | - A health professional, in the context of a directed donation, did not always 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 always 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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| 11 | 44- Quality Management System | - Some processes were not described in standard operating procedures.
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| 12 | 44- Quality Management System | - Some standard operating procedures were not kept up to date.
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| 13 | 45- Quality Management System | - The establishment’s internal audit system did not meet some of the requirements.
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| 14 | 48- Tracing and Identifying | - The primary establishment did not always assign a donation code to each donation of sperm and ova.
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| 15 | 53- 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.
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| 16 | 59- Errors and Accidents | - The establishment’s system for error and accidents did not meet some of the requirements.
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| 17 | 84- Records | - The establishment’s records were not always accurate, complete, legible and/or indelible.
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