Mich. Admin. Code R. 338.588b

Current through Vol. 24-22, December 15, 2024

Section R. 338.588b - Automated devices in medical institutions

Rule 88b.

(1) An automated device used by staff to store medications intended for patient administration in any hospital, county medical care facility, nursing home, hospice, or another skilled nursing facility, as that term is defined in section 20109 of the code, MCL 333.20109, must comply with all of the following:

(a) The automated device must be stocked, maintained, and controlled by a pharmacy that is licensed in this state.

(b) If the stocking of the automated device is performed by non-pharmacist personnel, then technologies must be in place and utilized to ensure that the correct drugs are stocked in their appropriate assignment utilizing bar-coding or another board-approved error-prevention technology that complies with R 338.3154.

(c) A pharmacy operating an automated device is responsible for all medications that are stocked and stored in that device, as well as removed from that device.

(d) If any medication or device is dispensed from an automated device, then documentation as to the type of equipment, serial numbers, content, policies, procedures, and location within the facility must be maintained by the pharmacy for review by an agent of the board. The documentation must include all of the following information:

(i) Name and address of the pharmacy responsible for the operation of the automated device.

(ii) Name and address of the facility where the automated device is located.

(iii) Manufacturer name and model number.

(iv) Quality assurance policy and procedure to determine continued appropriate use and performance of the automated device.

(v) Policy and procedures for system operation that address, at a minimum, all of the following:

(A) Accuracy.

(B) Patient confidentiality.

(C) Access.

(D) Data retention or archival records.

(E) Downtime procedures.

(F) Emergency procedures.

(G) Medication security.

(H) Quality assurance.

(I) Ability to provide on demand to an agent of the board a list of medications qualifying for emergency dose removal without pharmacist prior review of the prescription or medication order.

(2) An automated device that is operated at a location affiliated with a hospital, but not at the same physical address as the pharmacy, which is owned and operated by the hospital, must comply with section 17760 of the code, MCL 333.17760.

Mich. Admin. Code R. 338.588b

2024 MR 5, Eff. 2/29/2024