N.J. Admin. Code § 13:39-1.9

Current through Register Vol. 56, No. 11, June 3, 2024

Section 13:39-1.9 - Continuous quality improvement program

(a) A pharmacy permit holder and registered pharmacist-in-charge shall implement a continuous quality improvement program (CQI) to detect, identify, and prevent prescription errors.

1. The primary purpose of the CQI shall be to advance error prevention by analyzing, individually and collectively, investigative and other pertinent data collected in response to a prescription error to assess the cause and any contributing factors, such as system or process failures.

(b) The continuous quality improvement program shall be set forth in the pharmacy's written policies and procedures manual and, at a minimum, include:

1. Required documentation including, but not limited to:

i. Incident reports;

ii. Resolutions;

iii. Root cause analyses;

iv. CQI program meeting minutes and attendance records; and

v. Corrective action plans;

2. An internal incident reporting system;

3. Assessment of prescription errors to determine the cause of the error;

4. The appropriate response to the error; and

5. Meetings conducted at least once every three months, to discuss the results of, and any issues identified from, the continuous quality improvement program, and any corrective action plans. Meetings shall be conducted in-person or through live, interactive webinars and must include, at a minimum, those personnel involved in an error under review and their supervisors. The pharmacy permit holder must document that pharmacy personnel who did not attend the CQI meeting have received the CQI meeting minutes and that the pharmacy permit holder has communicated any changes to policies and procedures resulting from a CQI meeting with those personnel affected by such changes.

(c) A pharmacy permit holder shall use the findings of its continuous quality improvement program to develop pharmacy systems and workflow processes designed to prevent prescription errors, as well as communicate those findings to all pharmacy personnel.

(d) For a pharmacy that submits quality-related events to a patient safety organization (PSO) for primary quality improvement, the Board shall deem the pharmacy as having a continuous quality improvement program if the PSO satisfies the minimum requirements of this section.

(e) Notwithstanding compliance with a continuous quality improvement program or participation in a patient safety organization, in accordance with N.J.A.C. 13:45C-1, each licensee, registrant, and permit holder retains a duty to cooperate with each Board inquiry, inspection, or investigation.

N.J. Admin. Code § 13:39-1.9

Adopted by 54 N.J.R. 1916(a), effective 10/3/2022