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– MASSACHUSETTS –
Public and Private Policy
Medical Errors and Patient Safety

Definitions

There are two major categories of reportable health care events in Massachusetts. The Department of Public Health (MDPH) mandates reporting by medical facilities of “serious incidents”. The Board of Registration in Medicine mandates reporting by physicians of “major incidents”. There are a total of 33 distinct reportable events mandated by these two reporting entities, many of which are listed as interpretive guidelines provided in DHCQ circular letters to healthcare facilities.

  • •  Massachusetts DPH Division of Health Care Quality Regulations

    105 CMR § 130.331 – Serious Incident and Accident Reports

    • (A) Each hospital shall immediately report by telephone to the Department any of the following which occurs on premises covered by its license:
      • (1) Fire;
      • (2) Suicide;
      • (3) Serious criminal acts;
      • (4) Pending or actual strike action by its employees, and contingency plans for operation of the hospital;
      • (5) Serious physical injury to a patient resulting from an accident or unknown cause.

    The de facto interpretive guidelines for these definitions are provided in DHCQ 12-98-385 of December 7, 1998 and in DHCQ 04-03-439 of March 3, 2004.

    For Maternal-Newborn Services, 105 CMR §628 requires reporting of a maternal death within 90 days of delivery or termination of pregnancy, and for Satelling-Emergency Facilities, 105 CMR §836 requires a quarterly report of all deaths, volume, hospital transfers, and known hospital admissions within 72-hours of a SEF visit.

  • •  Board of Registration in Medicine Regulations

    243 CMR, § 3.08(2) – Major Incidents

    • (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 above) 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.*
    • * "major incidents" include adverse events that are not medical errors
  • •  Board of Registration in Medicine Regulations - Physician's Office Setting

    243 CMR, § 3.11(1) – Qualified Care Assessment Safety Program - Licensee's Office Setting

    • (1) In the case of a licensee's office setting outside of the purview of a health care facility's Qualified Patient Care Assessment Program, the licensee must file an Incident Report, in the manner prescribed by 243 CMR §3.08 ("Incident Reporting to the Board of Registration in Medicine"), with the Board, in the following circumstances:
      • (a) Category I incidents: Unplanned transfer to a hospital precipitated by an invasive procedure performed in the office.
      • (b) Category II incidents: major or permanent impairments of bodily functions or death that are not ordinarily expected as foreseeable results of the patient's condition or of appropriately selected and administered treatment.

    The Board of Registration in Medicine's PCA Program is unique in that it requires health care facilities to report on their ongoing quality improvement activities, as well as any quality improvements made following the investigation of a Major Incident. Participation in PCA programs is a condition of both hospital and physician licensure. The web-based “Major Incident Reporting Form”, the 2002 Report – Enforcement and Public Information [PDF] , and the 2003 Report – PCA Committee activity [PDF] are available for perusal.

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