Md. Code Regs. 10.34.26.04

Current through Register Vol. 51, No. 12, June 14, 2024

Section 10.34.26.04 - Ongoing Quality Assurance Program

A. A pharmacy permit holder shall establish and maintain an ongoing quality assurance program to:

(1) Identify, investigate, and promote the prevention of medication errors; and

(2) Establish protocols and procedures to minimize the potential for medication errors.

B. The ongoing quality assurance program shall include the records, proceedings, files, and any other documents of the ongoing quality assurance program, including for each medication error:

(1) The date of the error;

(2) A brief description of the error;

(3) The results of the evaluation by the ongoing quality assurance program's investigation; and

(4) Remedial action taken or recommendations.

C. Periodic Review.

(1) A pharmacy permit holder shall analyze the records, proceedings, files, and any other documents of the ongoing quality assurance program required under §B of this regulation, including any medication errors relating to automated medication systems or unlicensed personnel, at least every 3 months as part of the periodic review that is required to maintain an ongoing quality assurance program.

(2) Each pharmacy permit holder shall conduct an analysis of its medication delivery system at least every 6 months to determine which medications in the prescription area of the pharmacy are high-alert medications, as part of the pharmacy's ongoing quality assurance program.

D. Documentation of Periodic Review. The records, proceedings, files, and any other documents of the ongoing quality assurance program shall include for each:

(1) Periodic review required under §C(1) of this regulation:

(a) Documentation of the periodic review;

(b) A description of the system's weaknesses found during the periodic review; and

(c) A description of the actions taken to remedy any weaknesses identified in the medication system; and

(2) Analysis of a pharmacy's medication delivery system to identify high-alert medications required under §C(2) of this regulation:

(a) A list of high-alert medications present in the prescription area of the pharmacy;

(b) The date that a high-alert medication was added to or removed from the list of high-alert medications;

(c) Dates that the list was reviewed by the pharmacy permit holder; and

(d) Remedial actions taken based on the review of the list of high-alert medications and any medication errors relating to the high-alert medications.

E. Unless otherwise specified in law, the permit holder shall maintain the ongoing quality assurance program records referred to in this regulation for 2 years.

F. The proceedings, records, and files of an ongoing quality assurance program that meets the requirements of Health Occupations Article, § 1-401, Annotated Code of Maryland, and this chapter, are not discoverable and are not admissible in evidence in any civil action, as provided in Health Occupations Article, § 1-401, Annotated Code of Maryland.

Md. Code Regs. 10.34.26.04