PDFWAC 246-874-050

Accountability requirements for an ADDD.

(1) The facility shall have a mechanism for securing and accounting for wasted, discarded, expired, or unused medication removal from the ADDD according to policies and procedures and existing state and federal laws and regulations.
(2) The responsible manager shall implement procedures and maintain adequate records regarding use and accountability of legend drugs, including controlled substances, in compliance with state and federal laws and regulations including, but not limited to:
(a) A system to verify the accuracy of controlled substance counts shall include:
(i) Controlled substances must be perpetually inventoried with a blind count each time they are accessed in an ADDD; except for controlled substances dispensed in dose specific amounts by an ADDD to a Washington state credentialed health care professional acting within their scope of practice without access to the remaining controlled substance inventory; or
(ii) All controlled substances that are accessed for replenishment in an ADDD shall have an inventory count performed at that time. When replenishment or removal has not occurred, an inventory count shall occur at a minimum, once every seven days by two authorized persons licensed to handle drugs.
(b) Controlled substances must be stored in individually secured pockets or compartments within the ADDD. Storage in "matrix" drawers or open pocket drawers is prohibited.
(c) Facilities using a closed canister system must have a system to verify the accuracy of controlled substance counts by perpetual inventory that is regularly reviewed and reconciled by pharmacy staff.
(d) Controlled substance discrepancy monitoring and resolution, which includes:
(i) The responsible manager shall work with the facility or nursing administration to maintain an ongoing medication discrepancy resolution and medication monitoring process; and
(ii) A discrepancy report must be generated for each transaction where the count of a drug on hand in the device, does not reflect actual inventory. All resolved and open discrepancies must be reviewed by the responsible manager or designee within seven calendar days; and
(iii) Comply with all state and federal Drug Enforcement Administration reporting requirements.
(3) Wasted controlled substances. All controlled substances wasted shall have a witness, who is a Washington state credentialed health care professional, acting within their scope of practice; the record of waste shall be authenticated by both persons. A waste record must be readily retrievable in the ADDD, electronic health record, or as a hard copy report in accordance with the facility's policies and procedures. The report of waste shall include patient name, drug name, drug strength, date and time of waste, the amount wasted, and the identity of the person wasting and the witness. Waste records must be maintained for a minimum of two years.
[Statutory Authority: RCW 18.64.005 and chapter 18.64 RCW. WSR 17-07-027, § 246-874-050, filed 3/7/17, effective 4/7/17.]