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

Current through Register 1525, July 5, 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.