| 1 | 23- Donor Suitability Assessment | - The establishment’s structured donor screening questionnaire(s) did not include some criteria outlined in the Directive.
- The establishment did not always perform donor screening in accordance with the requirements set out in the Directive.
|
| 2 | 25- Donor Suitability Assessment | - The establishment did not always perform donor testing in accordance with the requirements set out in the Directive.
|
| 3 | 27- Donor Suitability Assessment | - The medical director did not always create and sign a summary document to confirm the donor suitability.
- The summary document confirming the donor suitability did not always include some required information.
|
| 4 | 32- Directed Donation Process | - The establishment’s structured donor screening questionnaire for directed donors did not include some criteria outlined in the directive.
|
| 5 | 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.
|
| 6 | 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 always perform some donor testing within the timeframe(s) set out in the Directive.
|
| 7 | 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.
|
| 8 | 43- Quality Management System | - The establishment’s quality management system did not meet the requirements of the Regulations.
- The establishment’s document control or records management system was not sufficient.
|
| 9 | 44- Quality Management System | - Some processes were not described in standard operating procedures.
|
| 10 | 44- Quality Management System | - The establishment did not review its standard operating procedures following an amendment to the Regulations and every two years after that event.
|
| 11 | 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.
|
| 12 | 5- Registration | - The primary establishment did not list the name and address for some establishments conducting processing activities on their behalf.
|
| 13 | 18- Notification | - The establishment did not notify Health Canada before distributing or importing sperm or ova.
|
| 14 | 33- Directed Donation Process | - The establishment did not always perform the physical examination in accordance with the requirements set out in the Directive.
|
| 15 | 44- Quality Management System | - Some standard operating procedures were not kept up to date.
|
| 16 | 45- Quality Management System | - The establishment’s internal audit system did not meet some of the requirements.
|
| 17 | 50- Labelling and Storing | - The primary establishment did not always ensure that the immediate container of sperm or ova was labelled in accordance with the requirements of the Regulations before distributing or making use of the sperm or ova.
|
| 18 | 57- Personnel, Facilities, Equipment and Supplies | - The establishment did not ensure that some critical equipment was validated, calibrated, cleaned or maintained as required.
|
| 19 | 58- Personnel, Facilities, Equipment and Supplies | - The expiry dates of critical supplies were not always observed.
- Critical supplies were not always stored under proper environmental conditions.
|
| 20 | 59- Errors and Accidents | - The establishment’s system for error and accidents did not meet some of the requirements.
|
| 21 | 84- Records | - The establishment’s records were not always accurate, complete, legible and/or indelible.
|
