Guideline text:
(Rev. 37, Issued:  10-17-08; Effective/Implementation Date:  10-17-08)

§482.25(a)(3) - Current and accurate records must be kept of the receipt and disposition of all scheduled drugs.

## Interpretive Guidelines §482.25(a)(3)

Components of a record system to maintain current and accurate records of the receipt and disposition of scheduled drugs would include:

- Accountability procedures to ensure control of the distribution, use, and disposition of all scheduled drugs.
- Records of the receipt and disposition of all scheduled drugs must be current and must be accurate.
- Records trace the movement of scheduled drugs throughout the service.
- The pharmacist is responsible for determining that all drug records are in order and that an account of all scheduled drugs is maintained and reconciled.
- The record system, delineated in policies and procedures,  tracks movement of all
- scheduled drugs from the point of entry into the hospital to the point of departure either through administration to the patient, destruction or return to the manufacture. This system provides documentation on scheduled drugs in a readily retrievable manner to facilitate reconciliation of the receipt and disposition of all scheduled drugs.
- All drug records are in order and  an account of all scheduled drugs is maintained and any discrepancies in count are reconciled promptly.
- The hospital system is capable of readily identifying loss or diversion of all controlled substances in such a manner as to minimize the time frame between the actual loss or diversion to the time of detection and determination of the extent of loss or diversion?
- Facility policies and procedures should minimize scheduled drug diversion.

## Survey Procedures §482.25(a)(3)

- Determine if there is a record system in place that provides information on controlled substances in a readily retrievable manner.
- Review the records to determine that they trace the movement of scheduled drugs throughout the service.
- Determine if there is a system, delineated in policies and procedures, that tracks movement of all scheduled drugs from the point of entry into the hospital to the point of departure either through administration to the patient, destruction or return to the manufacture.  Determine if this system provides documentation on scheduled drugs in a readily retrievable manner to facilitate reconciliation of the receipt and disposition of all scheduled drugs.
- Determine if the pharmacist is responsible for determining that all drug records are in order and that an account of all scheduled drugs is maintained and periodically reconciled.
- Is the hospital system capable of readily identifying loss or diversion of all controlled substances in such a manner as to minimize the time frame between the actual losses or diversion to the time of detection and determination of the extent of loss or diversion?
- Determine if facility policy and procedures minimize scheduled drug diversion.

Structured rule (JSON):
{"intent_tags": ["safety", "quality", "compliance", "integrity"], "logic_config": {"required_artifact": "current, accurate, and reconciled records for receipt and disposition of all scheduled drugs"}, "rule_type": "existence", "scope_tags": ["clinical", "facility", "legal"]}