Section 3.08 - Qualified Patient Care Assessment Program - Major Incident Reporting to the Board of Registration in Medicine(1)Introduction. The requirement that health care facilities establish reporting and screening criteria for adverse events, as well as internal procedures for the review and analysis of incidents, is intended to promote quality assurance and peer review at each facility. In addition, to allow the Board to meet its own statutory responsibility for the oversight of quality assurance programs, each health care facility must report Major Incidents as defined in 243 CMR 3.08(2)(a) through (d) to the Board.(2) The following types of Major Incidents must be reported by the health care facility to the Board: (a) Maternal deaths that are related to delivery.(b) Death in the course of, or resulting from, elective ambulatory procedures.(c) Any invasive diagnostic procedure or surgical intervention performed on the wrong organ, extremity or body part.(d) All deaths or major or permanent impairments of bodily functions other than those reported in 243 CMR 3.08(2)(a) through (c) that are not ordinarily expected as a result of the patient's condition on presentation. The first three types of major incidents are specific outcomes that should be reported without regard to the underlying circumstances. The fourth type of major incident represents severe adverse outcomes that fall outside the realm of ordinarily expectable results, taking into account the nature of the underlying disease process and the recognized risks and benefits of appropriate medical responses to it. An event may be of this last type solely by virtue of its rarity as a natural outcome of the disease or intervention. Identification of an event as any one of the four types of major incidents, rare or not, does not necessarily indicate either that the outcome was preventable or that it resulted from substandard medical practice.
(3) Health care facilities shall file major incident reports with the Board on a quarterly basis. When reporting a major incident, health care facilities shall use the Board's form prescribed for that purpose. For each major incident, the form will require the submission of certain information including but not limited to a description of the major incident, the results of the internal investigation and a description of the corrective measures taken by the health care facility. The reporting of the name(s) of the licensee(s) involved in the major incident initially will be optional. If the health care facility chooses to withhold the name(s) of the involved licensee(s), the Board may require additional information to enable it to evaluate the licensee's background, skills and involvement in prior major incidents. If at any time during the course of its investigation, the Board requires the name(s) of the involved licensee(s) in order to assess the adequacy of the response of the health care facility's PCA program to the major incident, the facility shall provide such name(s).(4) If a health care facility is identified as deficient in the reporting of major incidents, the Board may request certain additional information from that facility consistent with its authority to request data under M.G.L. c. 111, § 203 and M.G.L. c. 112, §§ 5 and 5I.(5)243 CMR 3.08 does not relieve the health care facility of any other reporting obligation required under law or regulation, including but not limited to M.G.L. c. 111, § 53B.