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PDFWAC 246-874-040

Security and safety requirements for ADDD.

(1) The responsible manager shall ensure adequate security systems and procedures for the ADDD, addressing access, including:
(a) A system by which secure access of users is obtained by such methods as biometrics or some other secure technology; and
(b) Prevention of unauthorized access or use, including:
(i) System access for former employees, or individuals whose access or privileges have been changed or terminated, must be removed immediately or inactivated upon notification; and
(ii) Discharged patients shall have patient profiles removed from the ADDD as soon as possible but no later than twelve hours from notification of the discharge.
(2) The responsible manager or designee shall assign, discontinue, or change user access and types of drug privileges for accessing an ADDD. Access to the ADDD must be limited to those Washington state credentialed health care professionals acting within their scope of practice. Access to the ADDD by facility information technology employees or employees of similar title must be properly restricted and addressed in policies and procedures.
(a) Replenishment of medications in an ADDD is reserved to:
(i) A pharmacist, pharmacy intern, or a pharmacy technician under the supervision of a pharmacist; or
(ii) A Washington state licensed registered nurse or licensed practical nurse may replenish an ADDD using an electronic verification system, that ensures exact placement of secured compartments into the ADDD;
(b) Pharmacists must provide an independent double check of all medications to be distributed to an ADDD in the absence of an approved specialized function or electronic verification system used in stocking an ADDD. A pharmacy technician that meets the criteria for specialized functions in WAC 246-901-035(1) may also provide the independent double check in place of a pharmacist. Electronic verification system checking or other approved technology may be used in place of an independent manual double check.
(3) A pharmacist shall perform prospective drug utilization review and approve each medication order, except if:
(a) The drug is a subsequent dose from a previously reviewed drug order;
(b) The prescriber is in the immediate vicinity and controls the drug dispensing process;
(c) The system is being used to provide access to medications on override and only a quantity sufficient to meet the immediate need of the patient is removed; or
(d) When twenty-four hour pharmacy services are not available.
(4) When twenty-four hour pharmacy services are not available, a pharmacist shall perform retrospective drug utilization review within six hours of the pharmacy being open, except when a dispensed override medication is a one-time dose or order for discharged patients.
(5) The pharmacist shall reconcile and review all medication orders added to a patient's profile outside of the facility's normal admission discharge transfer process and procedures, no later than the next business day.
(6) Medications or devices may only be returned directly to the ADDD for reissue or reuse consistent with policy and procedures for safe and secure medication processes, which include, but are not limited to:
(a) Medications or devices stored in unsecured patient specific bins, matrices, or open pockets, such as home medications or multiple use patient specific bottles may be returned to an ADDD so long as adequate controls are in place to ensure proper return. Controlled substances cannot be returned to unsecured patient specific bins, matrices, or open pockets.
(b) Medications stored in patient specific containers may not be returned to general stock for reuse.
(7) The responsible manager shall ensure a method is in place to address breach of security of the ADDD including, but not limited to:
(a) Tracking of malfunction and failure of the ADDD to operate correctly; and
(b) Downtime procedures in the event of a disaster or power outage that interrupts the ability of the pharmacy to provide services.
(8) An ADDD used in an assisted living facility must be located in a secure area. The area where the ADDD is located and the ADDD shall be locked when not in use.
[Statutory Authority: RCW 18.64.005 and chapter 18.64 RCW. WSR 17-07-027, ยง 246-874-040, filed 3/7/17, effective 4/7/17.]
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