Or. Admin. Code § 855-041-6540

Current through Register Vol. 63, No. 12, December 1, 2024

Section 855-041-6540 - Automated Distribution Cabinets

(1) Each ADC must be under the control of the pharmacy. The PIC must establish policies and procedures to meet the requirements of all applicable state and federal laws and regulations.

(2) Policies and procedures addressing the operation of the ADC must be maintained in the pharmacy. They must include:

(a) Training of personnel granted access to the ADC;

(b) System operation, safety, security, access, accuracy and patient confidentiality;

(c) Cabinet replenishment procedures;

(d) Downtime procedures;

(e) A procedure for securing and accounting for any wasted, discarded or unused drug in accordance with existing state and federal laws and regulations.

(3) All events involving the contents of the ADC must be recorded and must include:

(a) Identity of ADC accessed;

(b) Identification of the individual accessing the ADC;

(c) Type of transaction;

(d) Date and time of transaction;

(e) Name, strength, dosage form and quantity of the drug accessed;

(f) Name of the patient or patient identifier for whom the drug was ordered;

(g) Such additional information as the PIC may deem necessary.

(4) Only a pharmacist, pharmacy technician, certified pharmacy technician, intern or other person designated by the PIC may have access to the ADC.

(5) Stocking drugs in an ADC:

(a) Only a pharmacy technician, certified pharmacy technician, intern, pharmacist or other licensed healthcare personnel designated by the PIC may stock drugs in the ADC;

(b) A pharmacist must visually or electronically verify the name, strength and accuracy of the drug to be released from the central pharmacy for restocking;

(c) When a barcode or other electronic system is used to confirm the accuracy of the replenishment of the stock in an ADC, the system must receive an initial quality assurance validation;

(d) When all drug doses for an individual storage unit or bin have been packaged in one container, a single barcode verification may be used;

(e) The PIC must monitor the accuracy of the replenishment of drugs with a quality assurance process that includes:

(A) Reconciling the ADC fill list with established unit specific drugs using the drug profile, ADC discrepancy and inventory reports; and

(B) Monitoring the accuracy of the restocking and withdrawal procedures used by all hospital staff approved for drug administration.

(f) The PIC may permit medical supplies and devices to be included in the ADC.

(6) All drugs stored in the ADC must be packaged and labeled in accordance with state and federal laws and regulations.

(7) A drug that has been removed from the ADC for any purpose may not be returned to the system unless:

(a) A pharmacist has examined the drug, the packaging, and the labeling and determined that reuse of the drug is appropriate; or

(b) It is a drug, such as a multi-dose vial, which has been exempted by the appropriate hospital committee.

(8) At the time of loading, unloading, inventorying, removing or accessing any controlled substance from the ADC, a blind count or confirmation of the correct count must be conducted. Any discrepancy must be reported immediately to the PIC or pharmacist on duty who is responsible for reconciliation of the unresolved discrepancy or proper reporting of the loss.

Or. Admin. Code § 855-041-6540

BP 3-2010, f. 4-29-10, cert. ef. 4-30-10

Stat. Auth.: ORS 689.205

Stats. Implemented: ORS 689.155