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PDFWAC 246-874-030

General requirements for an ADDD.

(1) The pharmacy and any facility using an ADDD shall have written policies and procedures in place prior to any use of an ADDD. The responsible manager shall review the written policies and procedures at least annually and make the necessary revisions. The pharmacy or facility must document the required annual review and make the annual review available upon request by the commission or its designee. Electronic documents made available on a computer at the facility or pharmacy are permissible.
(2) The pharmacy or facility must maintain a current copy of all policies and procedures related to the use of the ADDD and make them available within the pharmacy or facility where the ADDD is located and make available upon request to the commission or its designee. Electronic documents made available on a computer at the facility or pharmacy are permissible.
(3) The policies and procedures must include, but are not limited to:
(a) All sections of part 1;
(b) User privileges based upon user type;
(c) Criteria for selection of medications subject to override and an override list approved by the pharmacy or facility's pharmacy and therapeutics committee or equivalent committee;
(d) Diversion prevention procedures; and
(e) Record retention and retrieval requirements that adhere to all state and federal laws and regulations. Records must be retained for a minimum of two years.
(4) An ADDD shall collect and maintain all transaction information including, but not limited to, the identity of the individuals accessing the system and identity of all personnel loading the ADDD, to accurately track the movement of drugs into and out of the system for security, accuracy, and accountability. The pharmacy or facility must maintain all records of transactions and make available upon request to the commission or its designee. Electronic documents made available on a computer at the facility or pharmacy are permissible.
(5) Inventory control.
(a) Authorized personnel must place drugs into the ADDD in the manufacturer's original sealed unit dose or unit-of-use packaging, in repackaged unit-dose containers, or in other suitable containers to support patient care and safety, and in accordance with federal and state laws and regulations;
(b) When applicable, patient owned medications that have been properly identified and approved for use per the facility's policies, may be stored in accordance with policies for safe and secure handling of medication practices.
(6) The responsible manager may designate a Washington state credentialed health care professional acting within their scope of practices as a designee to perform tasks in part 1. The responsible manager shall retain all professional and personal responsibility for any assisted tasks performed by personnel under his or her responsibility, as shall the pharmacy employing such personnel.
[Statutory Authority: RCW 18.64.005 and chapter 18.64 RCW. WSR 17-07-027, ยง 246-874-030, filed 3/7/17, effective 4/7/17.]
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