Retention of Derivative records Flashcards
Inspection of incoming derivatives upon receipt
10 years
Traceability of derivatives to final disposition
10 years
Requests for derivatives
10 years
Preparation of derivatives to include: Type of derivative Lot number Quantity Expiration date and time Personnel who prepared it
10 years
Issue of derivatives, including:
The manufacturer’s package insert documents are present and are issued
Product quantity and name matches request
Final inspection
Personnel dispensing
Personnel accepting
If issued for a patient, the intended recipient’s 2 unique identifiers
Date and time
10 years
If derivative returned for reissue, confirmation that the container closure has not been disturbed and confirmation that the derivative is suitable for reissue
10 years
Patient’s medical record for receipt of derivative to include product name, lot number, quantity, date and time, individual administering derivative and any adverse events
10 years beyond the date of distribution, date of infusion, date of deposition, or date of expiration, whichever is the latest date
Identification of nonconforming derivatives
10 years
Investigation of adverse effects, disease transmission, or other suspected adverse events of derivative use and reporting of such cases to the supplier or manufacturer and outside agencies
10 years
Appropriate discard
10 years
