Code of Massachusetts Regulations
243 CMR - BOARD OF REGISTRATION IN MEDICINE
Title 243 CMR 3.00 - The Establishment Of And Participation In Qualified Patient Care Assessment Programs, Pursuant To M.G.L. c. 112, Section 5, and M.G.L. c. 111, Section 203
Section 3.07 - Qualified Patient Care Assessment Program - Internal Audits and Internal Incident Reporting
Universal Citation: 243 MA Code of Regs 243.3
Current through Register 1531, September 27, 2024
(1) Pursuant to M.G.L. c. 111, § 203(a), the bylaws of both the health care facility and the medical staff shall contain provisions for reporting conduct of a health care provider that indicates incompetency in his or her specialty or conduct which might be inconsistent with or harmful to good patient care and safety. The Patient Care Assessment Coordinator shall be responsible for assuring investigation of such reports, and he shall directly review the report, resolution and follow-up.
(2) Pursuant to M.G.L. c. 111, § 203(b), the bylaws of the medical staff shall provide that, whenever following review by a medical peer review committee, or equivalent body, at a health care facility, a determination is reached that a health care provider should be subject to a disciplinary action, such committee shall immediately forward the recommendation to the executive committee of the medical staff and the health care facility's board of trustees or governing body for action. If the health care provider subject to the disciplinary action is not a licensee, then such "action" "forwarded" shall include referral to the appropriate department. Matters relating to non-physician health care providers may be assessed by medical peer review committees consisting entirely or predominantly of non-physician members.
(3) The health care facility and medical staff bylaws shall authorize the establishment of the following elements of a Qualified Patient Care Assessment Program:
(a) The development and implementation of an
incident reporting system based upon an affirmative duty of all health care
providers to report injuries and incidents in writing to the Patient Care
Assessment Coordinator. As part of the incident reporting system, procedures
shall be detailed in writing and disseminated to all employees of the health
care facility involved in patient care. All new employees, within five days of
employment, shall receive written instructions, and within thirty days, shall
receive orientation and training, in the operation of the system and their
responsibilities within it. At least annually, all appropriate employees shall
be provided at least three hours patient care assessment and quality assurance
education and training, with emphasis upon the importance of accurate and
timely incident reporting. All new employees' education and training and all
annual training shall also include specific instruction in Patients' Rights
pursuant to M.G.L. c. 111, § 70E.
(b) No later than November 1, 1987,
generation of Required Internal Incident Reports under the Focused Occurrence
Reporting Criteria and other incident reports. The Focused Occurrence Reporting
Criteria shall define specific adverse patient occurrences that must be
reported either at the time they are observed or within no more than 24 hours
thereafter. The health care facility shall file its Focused Occurrence
Reporting Criteria with the Board when adopted or amended by the health care
facility. Upon request, the Board shall provide technical assistance in
developing Focused Occurrence Screening Criteria.
(c) No later than November 1, 1987,
generation of Required Internal Incident Reports through Occurrence Screening
wherein all or a percentage of patients' medical records are reviewed shortly
after discharge under Occurrence Screening Criteria. These criteria should be
designed to reveal, through a chart review process, adverse or potentially
adverse patient occurrences that might not otherwise be evident. The health
care facility shall file its Occurrence Screening Criteria with the Board when
adopted or amended by the health care facility. Upon request, the Board shall
provide technical assistance in developing Occurrence Screening
Criteria.
(d) The Patient Care
Assessment Coordinator shall be responsible for the investigation and analysis
of the frequency and causes of general categories and specific types of all
Required Internal Incident Reports and any other incident reports, and shall
also be responsible for:
1. Reviewing and
acting upon incident reports to assure follow-up with individuals involved in
the incident.
2. The regular and
systematic reviewing of all incident reports for the purposes of identifying
trends or patterns as to time, place, and person. Upon emergence of any trend
or pattern in incident occurrence, the Patient Care Assessment Coordinator
shall develop written recommendations for appropriate corrective actions and
patient pro- tection/risk management/quality assurance education and training;
and
3. Creation of a random chart
audit system to assure compliance with the incident reporting requirements. The
Patient Care Assessment Coordinator shall establish written step-by-step
procedures for the follow-up required by 243 CMR 3.07(3)(d)1.
(e) The development of other
appropriate measures to minimize the risk of injuries and incidents to
patients.
(f) The central
collection of, investigation of, analysis of, and timely response to patient
complaints which relate to patient care and the quality of medical
services.
(g) No later than 30 days
after the end of each six-month period (or more often, if the governing body so
requires), beginning with the period that ends on the dates set forth in 243
CMR 3.07(3)(g)1. through 3., the Patient Care Assessment Coordinator or person
serving in a similar capacity at each health care facility listed below shall
provide a summary report to the health care facility's governing body, with a
copy of the report filed simultaneously with the Board. The report shall
contain recommendations for quality assurance, risk management, patient care
assessment and education. The ending date for the first six-month period shall
be as follows:
1. December 31, 1988, for
mental health clinics licensed by the Department of Public Health and subject
to
105 CMR
140.500: Applicability of
105 CMR
140.000 Subpart E;
2. February 28, 1989, for all other licensed
clients, and for all hospitals that provide obstetrical services or are
authorized to apply to the Board for limited licenses on behalf of interns and
residents; and
3. April 30, 1989,
for all other hospitals, and all other health care facilities subject to 243
CMR 3.07. The information required to be reported to the Board pursuant to
243 CMR 3.11(4)
(the Patient Care Assessment Program Annual
Report) shall be incorporated into the first semi-annual report and each
semi-annual report filed at 12-month intervals thereafter. The information
required by
243 CMR 3.11(4)
that is contained in the first semi-annual
report shall cover the period from the filing of the previous annual report
(or, in the case of mental health clinics identified in 243 CMR 3.07(3)(g)1.,
the prior 12-month period). The effect of 243 CMR 3.07(3)(g), effective
November 25, 1988, is that the previously required quarterly report is now
semi-annual, and the previous requirement for an annual report remains
unchanged.
(h) A
requirement that all incident reports, summary reports and written
recommendations to and from the Patient Care Assessment Coordinator shall be
maintained for three years.
(i) A
requirement of documentation of any disciplinary action.
(j) All incident reports shall be in writing
on a form developed by the health care facility for such purpose and shall
contain at least the following information:
1. The patient's name, locating information,
admission date, age and sex.
2. A
clear and concise description of the incident, including time, date, exact
location.
3. A listing of all
persons known to be involved in the incident, including witnesses, along with
locating information for each.
4.
The name, signature and position of the person completing the report, and the
date and time that the report was completed.
(k) Provisions to grant the Board and the
Department of Public Health with access and audit authority over Qualified
Patient Care Assessment Program information and records during normal business
hours.
(l) Provisions to require
administration of a reasonable and comprehensive evaluation of a licensee's
clinical skills, competence and judgment, upon request of and for filing with
the Board.
(m) The governing body
shall establish a committee charged with overseeing safety and maintenance of
facilities and equipment, and the Patient Care Assessment Coordinator shall
receive periodic reports from this committee.
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