Retention of Tissue Records

Question 1

Inspection of incoming tissue upon receipt

Answer 1

10 years

Question 2

traceability of tissue and final disposition

Answer 2

10 years

Question 3

Requests for tissue

Answer 3

10 years

Question 4

Preparation of tissue including:

1. Type of tissue
2. Numeric or alphanumeric identifier
3. Quantity
4. Expiration date and time
5. Personnel who prepared

Answer 4

10 years

Question 5

Issue of tissue, including:

1. Manufacturer’s package insert documents present and issued
2. Product quantity and name matches request
3. Final inspection
4. Personnel dispensing
5. Personnel accepting
6. If issued for particular patient, the intended recipient’s two independent identifiers
7. Date and time

Answer 5

10 years

Question 6

If a tissue is returned for reissue, confirmation that the container closure has not been disturbed and confirmation that the tissue is suitable for reissue

Answer 6

10 years

Question 7

Patient’s medical record for receipt of tissue to include the type, numeric/alphanumeric identifier, quantity, expiration date, date of use, personnel using the tissue and any adverse events

Answer 7

10 years beyond the date of final disposition

Question 8

Identification of nonconcurring tissue

Answer 8

10 years

Question 9

Investigation of adverts effects, disease transmission, or other suspected adverse events of the the tissue and reporting such cases to the tissue supplier or manufacturer, and outside agencies

Answer 9

10 years

Question 10

Appropriate discard of tissue

Answer 10

10 years