9.2 Continuous Quality Improvement & Quality Related Events
Key Takeaways
Continuous quality improvement is governed by 247 CMR 15.00 — not by 247 CMR 9.00 — and every pharmacy must establish a CQI programme to detect, document, assess and prevent quality related events.
A CQI programme must designate a responsible individual, identify and document QREs, minimise their impact on patients, analyse the data for causes and contributing factors, use the findings to change systems and workflow, and provide CQI education to pharmacy personnel at least annually.
All pharmacy personnel must bring a QRE to the pharmacist on duty or the Manager of Record immediately, and the pharmacist must immediately notify the patient, notify the prescriber where professional judgement indicates, give directions for correcting the error and minimise the negative impact.
A QRE must be initially documented by the discovering pharmacist within 24 hours of discovery or notification.
QRE records are retained for a minimum of two years from the date of the QRE report, filed in an orderly manner by date, and may be stored off site.
Continuous Quality Improvement & Quality Related Events
Important
Cite 247 CMR 15.00. Continuous quality improvement has its own chapter. It is not part of 247 CMR 9.00, and the reporting duties that attach to serious outcomes are in a third chapter again, 247 CMR 20.00. Three chapters, three different jobs.
The Programme — 247 CMR 15.02
Each pharmacy shall establish a Continuous Quality Improvement (CQI) Program for the purpose of detecting, documenting, assessing and preventing Quality Related Events (QREs). At a minimum, a CQI programme shall include provisions to:
- designate an individual or individuals responsible for monitoring compliance with 247 CMR 15.00;
- identify and document QREs;
- minimise the impact of QREs on patients;
- analyse the data collected in response to QREs to assess causes and any contributing factors;
- use the findings of the analysis to formulate an appropriate response and develop pharmacy systems and workflow processes designed to prevent QREs; and
- provide ongoing education at least annually in the area of CQI to pharmacy personnel.
The six elements are a checklist, and "at least annually" is the only frequency the regulation specifies.
Discovery and Immediate Response — 247 CMR 15.03(1)
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:
- notification to the patient or the patient's representative, to the prescriber (if indicated in the professional judgement of the pharmacist), and to other members of the health care team;
- directions for correcting the error; and
- instructions for minimising the negative impact on the patient.
Warning
Patient notification is unqualified; prescriber notification is not. The regulation requires notification to the patient or the patient's representative. Notification of the prescriber is expressly conditioned on the pharmacist's professional judgement. Reversing these two is a classic distractor.
Documentation — 247 CMR 15.03(2)
A QRE shall be initially documented by the pharmacist who discovered or was informed of it within 24 hours after the QRE is discovered by or described to the pharmacist.
The documentation must be sufficient to permit categorisation and analysis, and must include:
- the date the pharmacist discovered or received notification of the QRE, and the name of the person who notified the pharmacy;
- the names and titles of the persons recording the QRE information and performing the analysis;
- a description of the QRE reviewed; and
- documentation of the contact with the patient or the patient's representative, with the prescribing practitioner where professional judgement indicated, and with other members of the health care team.
Analysis and Response — 247 CMR 15.03(3)
The investigative and other pertinent data collected in response to QREs shall be analysed individually and collectively to assess the cause and any contributing factors such as system or process failures. The analysis and assessment shall include:
- consideration of the effects on quality assurance related to workflow processes, technological support, personnel training and staffing levels;
- any recommended remedial changes to pharmacy policies, procedures, systems or processes; and
- the development of indicators that identify means against which the pharmacy's programme intends to measure its standards over a designated period.
Each pharmacy shall then inform pharmacy personnel of the changes to policies, procedures, systems or processes that result from the CQI programme's recommendations.
Important
Staffing levels are named in the regulation. 247 CMR 15.03(3)(a)(1) expressly directs the analysis to consider staffing levels. Read with the Manager of Record's duty to plan and maintain adequate staffing that promotes patient safety, this is the Board telling pharmacies that error analysis cannot stop at "the pharmacist was careless."
Records — 247 CMR 15.04
- Each pharmacy shall maintain a written copy of its CQI Program description on the pharmacy premises, readily available to all pharmacy personnel.
- Each pharmacy shall maintain a record of all QREs for a minimum of two years from the date of the QRE report.
- QRE records shall be maintained in an orderly manner and filed by date.
- QRE records may be stored at a site other than the pharmacy where the QRE occurred.
CQI Does Not Discharge the Duty to Report
247 CMR 20.02(3) states plainly that the duty to report improper dispensing resulting in serious injury or death, and the duty to report a serious adverse drug event, are in addition to the CQI requirements of 247 CMR 15.00.
| Event | Where it goes | Deadline |
|---|---|---|
| Any QRE, including a near miss | Internal CQI documentation | 24 hours to initially document |
| Improper dispensing causing serious injury or death | The Board, under 247 CMR 20.02(1) | 7 business days from discovery |
| Serious adverse drug event from a drug made or compounded at the pharmacy | The Board, FDA MedWatch, and the Betsy Lehman Center | 7 business days from knowledge by any employee |
Records relating to the two reportable events must be kept five years from the date the report is filed (247 CMR 20.02(4)) — not the two years that applies to ordinary QRE records.
Caution
Do not claim a discovery privilege for CQI records. Some states protect pharmacy quality-assurance records from civil discovery by statute. 247 CMR 15.00 contains no such provision, and QRE records must be produced to the Board. Do not counsel colleagues that internal CQI documentation is shielded from disclosure.
Worked Traps
- A wrong-strength dispensing is caught by the patient at home and returned unused; the pharmacy does not log it. Violation — the QRE definition reaches events regardless of whether the patient took the medication, and the discovering pharmacist must document within 24 hours.
- A pharmacist documents a QRE five days later during a quiet shift. Late — the deadline is 24 hours.
- A dispensing error causes hospitalisation and the pharmacy files it only in the CQI log. Violation — 247 CMR 20.02(1) requires a Board report within seven business days.
- A root cause analysis concludes "technician error; retrained." Insufficient — 247 CMR 15.03(3) requires consideration of workflow, technological support, training and staffing levels, and the development of measurable indicators.
Which 247 CMR chapter contains the Massachusetts continuous quality improvement requirements, and how quickly must a quality related event be initially documented?
247 CMR 9.00; within seven business days
247 CMR 15.00; within 24 hours of discovery by or notification to the pharmacist
247 CMR 20.00; within 14 calendar days
247 CMR 10.00; before the end of the calendar quarter
A pharmacist discovers a dispensing error. Under 247 CMR 15.03(1), what must the pharmacist immediately provide?
Notification to the Board of Registration in Pharmacy and to the prescriber
Notification to the patient or the patient’s representative, notification to the prescriber if indicated in the pharmacist’s professional judgement, directions for correcting the error, and instructions for minimising the negative impact
A completed root cause analysis and corrective action plan
Written notice to the patient only, with no prescriber contact permitted before the analysis is complete
For how long must a Massachusetts pharmacy retain records of quality related events, and where may they be kept?
Two years from the date of the QRE report; they may be stored at a site other than the pharmacy where the event occurred
Five years from the date of the QRE report; they must be kept on the pharmacy premises at all times
Two years from the end of the calendar year; off-site storage is prohibited
Indefinitely, because QRE records are protected from discovery
Sections you finish are checked off in the contents.