247 CMR, § 15.03 - Quality Related Event Discovery, Notification and Documentation

(1) QRE Discovery and Notification. All pharmacy personnel shall be trained to bring any QRE to the attention of the pharmacist on duty or the pharmacist Manager of Record immediately upon discovery. The pharmacist who has discovered or been informed of a QRE shall immediately provide:

(a) notification to the patient or patient's representative, the prescriber (if indicated in the professional judgment of the pharmacist) and other members of the healthcare team;

(b) directions for correcting the error; and

(c) instructions for minimizing the negative impact on the patient.

(2) QRE Documentation.

(a) A QRE shall be initially documented by the pharmacist who has discovered or been informed of the QRE within 24 hours after the QRE is discovered by or described to the pharmacist.

(b) QRE documentation shall include a description of the event that is sufficient to permit categorization and analysis of the event. QRE documentation shall include:

1. the date when the pharmacist discovered or received notification of the QRE and the name of the person who notified the pharmacy;

2. the names and titles of the persons recording the QRE information and performing the QRE analysis;

3. a description of the QRE reviewed; and

4. documentation of the contact with the patient, or patient's representative, and prescribing practitioner (if indicated in the professional judgment of the pharmacist), and other members of the healthcare team.

(3) QRE Analysis and Response.

(a) QRE Analysis. The investigative and other pertinent data collected in response to QREs shall be analyzed, individually and collectively, to assess the cause and any contributing factors such as system or process failures. The QRE analysis and assessment shall include:

1. a consideration of the effects on quality assurance related to workflow processes, technological support, personnel training and staffing levels;

2. any recommended remedial changes to pharmacy policies, procedures, systems, or processes; and

3. the development of indicators that identify means against which a pharmacy's program intends to measure its standards over a designated period of time.

(b) Response. Each pharmacy shall inform pharmacy personnel of changes to pharmacy policies, procedures, systems, or processes resulting from recommendations generated by the CQI Program.

Notes

247 CMR, § 15.03

Amended by Mass Register Issue 1536, eff. 12/6/2024.