| 1 | 23- Donor Suitability Assessment | - The establishment did not always perform donor screening in accordance with the requirements set out in the Directive.
- The establishment’s structured donor screening questionnaire(s) did not include some criteria outlined in the Directive.
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| 2 | 25- Donor Suitability Assessment | - The establishment did not always perform all required testing on the donor.
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| 3 | 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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| 4 | 34- Directed Donation Process | - The establishment did not always perform all required testing on the directed donors in accordance with the Directive.
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| 5 | 43- Quality Management System | - The establishment did not establish and maintain a quality management system that includes a process control program.
- The establishment did not establish and maintain a quality management system that includes a document control or records management system.
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| 6 | 53- Personnel, Facilities, Equipment and Supplies | - The establishment did not always have sufficient personnel who are qualified by their education, training or experience to perform of their respective tasks.
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| 7 | 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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| 8 | 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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| 9 | 24- Donor Suitability Assessment | - The establishment did not perform the physical examination in accordance with the requirements set out in the Directive.
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| 10 | 26- Donor Suitability Assessment | - The primary establishment did not always ensure that a repeat donor was reassessed in accordance with the Directive.
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| 11 | 27- Donor Suitability Assessment | - The summary document confirming the donor suitability did not always include some required information.
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| 12 | 33- Directed Donation Process | - The establishment did not perform a physical exam on the directed donors in accordance with the Directive.
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| 13 | 36- Directed Donation Process | - The summary document confirming the directed donation did not always include all required information.
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| 14 | 43- Quality Management System | - The establishment did not have standard operating procedures for some of the activities that it conducts.
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| 15 | 44- Quality Management System | - Some processes were not described in standard operating procedures.
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| 16 | 44- Quality Management System | - Some standard operating procedures were not kept up to date.
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| 17 | 45- Quality Management System | - The establishment’s internal audit system did not meet some of the requirements.
- 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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| 18 | 84- Records | - The establishment’s records were not always accurate, complete, legible and/or indelible.
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