| 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.
- The establishment’s structured donor screening questionnaire for directed donors did not include some criteria outlined in the directive.
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| 2 | 35- Directed Donation Process | - The primary establishment did not always ensure that a repeat donor was reassessed in accordance with the Directive.
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| 3 | 43- Quality Management System | - The establishment’s document control or records management system was not sufficient.
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| 4 | 43- Quality Management System | - Some standard operating procedures were not always followed.
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| 5 | 44- Quality Management System | - Not all standard operating procedures were in a standard format
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| 6 | 44- Quality Management System | - Some processes were not described in standard operating procedures.
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| 7 | 44- Quality Management System | - Some standard operating procedures were not kept up to date.
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| 8 | 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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| 9 | 58- Personnel, Facilities, Equipment and Supplies | - The expiry dates of critical supplies were not always observed.
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| 10 | 59- Errors and Accidents | - The establishment’s system for error and accidents did not meet some of the requirements.
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| 11 | 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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| 12 | 84- Records | - The establishment’s records were not always accurate, complete, legible and/or indelible.
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