C ^^C {,'X:VX] nnftv?. Commonwealth ofMassachusetts Board ofRegistration in Medicine 10 West Street MA Ronton, 02111 31SDbb D270 144C GOVERNMENT DOCUME COLLECTION OCT 2 9 1999 University of Massachuset Depository C ,dy THE PATIENT CARE ASSESSMENT FUNCTION and the PROGRAM TO REPORT MAJOR INCIDENTS The Patient Care Assessment Committee Arnold S. Relman, M.D., Chairman The Patient Care Assessment Division Elizabeth O'Brien, MSPH, J.D., Director March, 1999 Argeo Paul Cellucci Governor Jane Swift Lieutenant Governor Daniel A. Grabauskas Director ofConsumerAffairs AndBusiness Regulation Massachusetts Board ofRegistration in Medicine Mary Anna Sullivan, M.D., Chair Alexander F. Fleming, Executive Director Penelope Wells, General Counsel Members ofthe Patient Care Assessment Committee Arnold S. Relman, M.D., Chairman Mary Anna Sullivan, M.D. Rafik Attia, M.D. Hart Achenbach, M.D., Volunteer Consultant Members ofthe Patient Care Assessment Division Staff Elizabeth O'Brien, MSPH, J.D., Director Maureen T. Keenan, R.N., J.D., Associate Director Robin McGinness Spencer, R.N., J.D., PCA Attorney 4 TABLE OF CONTENTS Background_ I. 1 PCA Programs - An Overview_ II. 3 PCA III. Board's Oversight of Programs _ 4 IV. Major Incident Reporting 5 _ V. Peer Review Privilege_ 8 PCA VI. "Updates" and PCA "Guidelines" 9 VII. Practical Suggestions and Advice for Reporting Major Incidents_ _ 10 General Advice 10 _ Deciding Whether an Incident Should be Reported (Type 12 4)_ Appendix Revised Major Incident Reporting Regulation_ 1 CMR 243 3.08 Digitized by the Internet Archive in 2012 with funding from Boston Library Consortium Member Libraries http://archive.org/details/patientcareassesOOmass Background I. The Patient Care Assessment (PCA) func- tion at the Board ofMedicine is responsible for the oversight ofinstitutional systems ofquality assur- ance, risk management, peer review, utilization re- view and credentialing, known collectively as a "PCA Program." The systems comprising a health PCA care facility's program must be overseen by both physician and corporate leadership and must actively involve all health care providers and most employees at the institution. The Board's PCA function was mandated by the Medical Malpractice Reform Act of 1986. This legislation was drafted in response to the ris- ing number ofpatient injuries and associated medi- cal malpractice claims, which, in turn, was causing an increase in the cost ofinsurance premiums. The legislation was also seen as a way to respond to criticism that health care facilities often ignored substandard physician performance. The key pro- visions ofthe Massachusetts General Laws dealing with the Board's oversight of institutional quality assurance are M.G.L. c. 1 1 1, § 203(d) and M.G.L. c. 1 12, § 5. These statutes include the require- PCA ments that participation in programs is a con- dition ofboth hospital and physician licensure. Following the enactment ofthese statutes, the Board promulgated regulations to carry out its legal mandate ofoverseeing institutional quality assurance. These regulations, known as the PCA CMR Regulations and found at 243 3.00, specify in detail the requirements broadly set out in the 1986 legislation. The regulations apply to all health care facilities, ranging from hospitals to HMOs to physicians' office settings, and include the requirement that physicians licensed in Massa- chusetts may not provide patient care at facilities PCA PCA without programs. In addition, the Committee (a subcommittee ofthe Board) and the PCA Division (a discrete unit ofthe Board's staff PCA that works with the Committee) were estab- PCA lished to implement the regulations and to carry out the new mandate. The PCA function is unique among the na- tion's state licensing boards. At first glance, it might seem unusual for the legislature to place oversight ofinstitutional quality assurance in a state agency that licenses physicians, but not health care facilities. On further reflection, how- ever, the rationale is clear and compelling: institu- tional quality assurance will not succeed without physician leadership and participation. The Board's PCA activities differ from its other, more traditional functions. The PCA Com- mittee is not punitive or adversarial in nature; it does not discipline physicians or regulate their li- censure. While its ultimate responsibility is pro- tection ofthe public, the Board's PCA Committee tries to be collaborative and educational when working with health care facilities. The PCA Com- mittee's purpose is to ensure that each health care facility does its job to assure quality; to accom- plish that end, it attempts to work collegially with facilities. The PCA Committee and Division are also unique in the confidential nature oftheir activities. Soon after the inception ofthe PCA function at the Board, the legislature passed a statute that afforded PCA information a high level oflegal protection from disclosure (M.G.L. c. 1 1 1, § 205). The stat- PCA ute provides that information is confidential and not subject to subpoena, discovery or introduc- PCA tion into evidence. Moreover, the Committee and Division do not share any ofthe information they receive with the Board's Enforcement Divi- sion. II. PCA Programs - An Overview A PCA health care facility's program is an integrated system ofquality assurance, peer re- view, credentialing, risk management, and utiliza- tion review that has as its goal the monitoring and improvement ofthe quality ofhealth care services. A PCA facility's program must be described in a written plan that is submitted to the Board for ap- proval. As stated above, physicians may not prac- tice at health care facilities without an approved PCA program; approval ofthe program is also a condition ofhospital licensure. The requirements ofa PCA program are PCA Two enumerated in the regulations. require- ments are general but critical to the program's suc- cess. First, within each facility, there must be a committee at the governing body level, known as PCA the facility's Committee, that has overall re- sponsibility for the PCA program. The facility's governing body and its PCA Committee must en- PCA sure that their program is an institutional pri- ority. Second, every physician must participate in PCA the program established by the health care facility at which s/he practices. In addition to these requirements, there must be internal systems for, among other things, physician credentialing; incident reporting; the processing ofpatient com- plaints; and acquiring patients' informed consent. PCA III. Board's Oversight of Programs The Board ensures that facilities have PCA programs in place by reviewing and approving their PCA plans. The PCA plan must describe in writing how the facility implements the require- ments found in the PCA regulations. To insure that the facility's PCA program is working, the Board requires three types ofreports. Two of these reports, called the PCA semi-annual and PCA annual reports, must be submitted by the fa- cility to its governing body, with copies furnished to the Board. The purpose ofthe PCA semi- annual and annual reports, which are essentially progress reports, is to apprise the health care facil- ity's governing body and the Board ofongoing PCA program activities. The third type ofreport required by the Board, perhaps the most critical of all, is the major incident report. IV. Major Incident Reporting Major incident reporting to the Board is a component ofa health care facility's overall inci- PCA dent reporting system, required as part ofits program. Reports ofmost incidents identified and tracked by the facility are internal matters and re- main within the institution. However, the details ofcertain incidents, which are designated as "major" because they result in a serious patient outcome, must be reported to the Board. These in- cidents involve deaths or serious injuries that were not ordinarily expected, based on the patient's con- dition upon presentation or admission to the facil- ity. The identification ofan event as a major inci- dent does not necessarily mean that the outcome was preventable or that it resulted from negligence or substandard care. Through its review ofmajor incident reports, the Board evaluates how a facil- PCA ity's program responds to a serious unex- pected outcome. Indeed, the reason major incident reports must be submitted to the Board on a quar- terly basis, and not immediately following an event, is to allow the facility's own PCA program to investigate what happened and to formulate an institutional response. In a major incident report, the facility must provide a medically coherent description ofthe event, a clear and thorough account ofthe results ofits investigation and a description ofall correc- tive measures taken in response to the incident. Following its review ofa major incident, the facil- ity may find that the event, while unexpected, could not have been prevented and therefore no corrective measures are in order. Alternatively, the facility may uncover problems that caused or con- tributed to the event, and decide that corrective measures are necessary. Either response is accept- able so long as the Board's PCA Committee is re- assured that the facility identified the incident, in- vestigated thoroughly and, when appropriate, has it taken the necessary steps to reduce the likelihood ofa recurrence. When a major incident occurs, neither the Board's PCA Committee nor its staffinitiates an immediate investigation ofthe event. The Board believes that such a response would undermine the PCA responsibility ofa facility's program to con- duct its own investigation. The PCA Committee is aware that unexpected, untoward outcomes occur even at the best health care facilities. Because the Committee holds health care facilities accountable for their own regulation, it expects cooperation as it assists them in monitoring and continuously im- proving the quality oftheir patient care. It is hoped that cooperation will be enhanced by the confidentiality afforded to major incident reports,