BETH ISRAEL HOSP. ASS’N v. BD. OF REGIST. IN MEDICINE, 401 Mass. 172 (1987)

515 N.E.2d 574

Supreme Judicial Court of Massachusetts. Suffolk.September 14, 1987.
November 23, 1987.

Present: HENNESSEY, C.J., WILKINS, LIACOS, ABRAMS, LYNCH, JJ.

Department of Public Health. Board of Registration in Medicine. Hospital, Peer review. Health Care Facility. Privileged Communication. Medical Malpractice, Hospital. Administrative Law, Regulations, Agency.

Statement of principles establishing the standard of judicial review applicable to regulations adopted by an administrative agency. [176-177] In an action under G.L.c. 30A, § 7, and c. 231A, by hospitals challenging the authority of the Board of Registration in Medicine to issue certain regulations and the consistency of those regulations with St. 1986, c. 351, and other statutes, there was no merit to the plaintiffs’ contention that 243 Code Mass. Regs. § 3.07 (3) (a) (1987), which places an “affirmative duty” on each health care provider to report “injuries and incidents” to the patient care assessment coordinator of the health care facility concerned, was invalid in that its requirements went beyond those of G.L.c. 111, § 203(a), or in that it created new duties and might affect employment relationships. [177-178] Regulations of the Board of Registration in Medicine, 243 Code Mass. Regs. § 3.08 and § 3.07 (3) (1) (1987), requiring, respectively, that hospitals report specified “Major Incidents” to the board and establish a system to provide “a reasonable and comprehensive evaluation of a licensee’s clinical skills, competence and judgment, upon request of and for filing with the [b]oard,” did not exceed the board’s authority consistent with its duty under St. 1986, c. 351, to provide hospitals with risk management programs, nor conflict with statutory provisions requiring health care facilities to furnish other reports to the board, nor undermine the confidentiality provided by G.L.c. 111, § 204 (a) — (d), to hospital peer review committees. [178-179] A regulation of the Board of Registration in Medicine, 243 Code Mass. Regs. § 3.07 (k) (1987), conflicted with the statutory privilege accorded

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the activities of hospital peer review committees by G.L.c. 111, § 204 (a) — (d), and thus was invalid to the extent it authorized the board access to the “proceedings, reports and records” of such committees [179-181]; however, in all other respects the regulation was consistent with the legislative scheme of St. 1986, c. 351, to provide hospitals with risk management programs [179-184].

An action by hospitals challenging certain regulations of the Board of Registration in Medicine presented no issue as to the validity of 243 Code Mass. Regs. § 3.04 (1987), providing for designating as confidential certain items “related to” the activities of hospital peer review committees. [184]

CIVIL ACTION commenced in the Supreme Judicial Court for the county of Suffolk on April 8, 1987.

The case was reported by Abrams, J.

Gerald Gillerman (Gordon P. Katz William M. Mandell with him) for the plaintiffs.

James M. Shannon, Attorney General (Carolyn V. Wood,
Assistant Attorney General, with him) for the defendant.

The following submitted briefs for amici curiae:

Harold J. Bressler of Illinois Richard A. Johnston, for Joint Commission on Accreditation of Hospitals.

Patrick R. Carroll, William T. McGrail Dorothy Grandolfi Wagg, for Massachusetts Hospital Association, Inc.

Alfred Miller, Peter N. Greenwald Joan S. Wise of New York, for American Association of Retired Persons.

Sander A. Rikleen, Walter L. Landergan, Jr., Kathleen R. Curtis Michael J. Kelly, for The Massachusetts Medical Society.

HENNESSEY, C.J.

The plaintiffs (hospitals) seek a declaration under G.L.c. 30A, § 7, and c. 231A that five regulations of the Board of Registration in Medicine (board) adopted following the enactment of St. 1986, c. 351 — “An Act relative to medical malpractice” — are invalid because they conflict with statutes and are beyond the board’s authority. A single justice of this court reported the case on the parties’ cross motions for summary judgment.

Chapter 351 was enacted in response to a perceived medical malpractice crisis. Chapter 351, to the extent pertinent here,

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amended sections of G.L.c. 111, which concern the Department of Public Health (DPH), and sections of G.L.c. 112, concerning the board.[2] The DPH is concerned with the “life, health, comfort and convenience” of Massachusetts citizens, and, more particularly, with hospital licensure. G.L.c. 111, §§ 5, 51 (1986 ed.). The board is responsible for regulating the practice of medicine, and, more particularly, for physician licensure. G.L.c. 112, §§ 2, 5 (1986 ed.).

Chapter 351, inter alia, requires reports to the board by a number of persons and organizations in circumstances of possible physician incompetence.[3] The statute also states that the board will provide “risk management programs” to hospitals,[4]
and makes participation in such programs a condition of hospital[5] and physician licensure.[6] Chapter 351 also amended G.L.c. 111 to provide that medical peer review committee (PRC) “proceedings, reports and records” shall be confidential and immune from subpoena or discovery and that those attending a PRC meeting shall not be required or allowed to testify about the PRC proceedings.[7] These protections of PRC activities do not apply to board proceedings.

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Following the enactment of c. 351 the board adopted regulations establishing the outlines of a Qualified Patient Care Assessment Program (QPCAP) which is the “risk management program” the board is charged with providing hospitals. See 243 Code Mass. Regs. § 3.02 (1987). The QPCAP seeks patient care improvement through, inter alia, strengthened requirements for establishing and verifying physicians’ professional credentials (“credentialing”), 243 Code Mass. Regs. § 3.05 (1987), and increased incident reporting both within hospitals and to the board, 243 Code Mass. Regs. §§ 3.07-3.08 (1987). Structurally, the QPCAP requires, at minimum, the establishment of a hospital governing board level PRC known as a Patient Care Assessment Committee and the appointment of a Patient Care Assessment Coordinator who is responsible for the QPCAP’s over-all operation. See 243 Code Mass. Regs. §§ 3.02, 3.06 (1987).[8] Medical staff level PRC’s are also contemplated by the regulations. 243 Code Mass. Regs. § 3.06 (1) (b).

The hospitals challenge the board’s authority to issue five of the regulations and the consistency of those regulations with c. 351 and other statutes. The challenged regulations are: 243 Code Mass. Regs. § 3.07 (3) (a), which requires all “health care providers” to report “injuries and incidents” to their Patient

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Care Assessment Coordinators; 243 Code Mass. Regs. § 3.08, which requires hospitals to report “major incidents” to the board; 243 Code Mass. Regs. § 3.07 (3) (1), which requires hospitals to provide evaluations of staff physicians on the board’s request; 243 Code Mass. Regs. § 3.07 (3) (k), which requires hospitals to allow the board and DPH to “access and audit” QPCAP information and records; and 243 Code Mass. Regs. § 3.04, which states that items the board receives “relate[d] to” PRC activities shall remain confidential. We conclude that 243 Code Mass. Regs. §§ 3.07 (3) (a), 3.08, and 3.07 (3) (1), are valid regulations. To the extent, and only to the extent, that 243 Code Mass. Regs. § 3.07 (3) (k) purports to grant the board and DPH access to PRC “proceedings, reports and records,” it conflicts with the protections granted by G.L.c. 111, § 204 (a) — (d), and is invalid. Our view of 243 Code Mass. Regs. § 3.07 (3) (k) makes it unnecessary to resolve the alleged controversy over 243 Code Mass. Regs. § 3.04. Standard of Review.

The hospitals concede that a “substantial burden [is] placed upon them in establishing the invalidity of the challenged regulations.” This court’s opinions establish that all presumptions are in favor of the validity of agency action, that a regulation may be authorized though not traceable to specific statutory language, that powers granted include those reasonably implied, that agencies have leeway in interpreting statutes they enforce, and that specific statutory authority does not bar consistent action under general authority. See, e.g., Grocery Mfrs. of Am., Inc. v. Department of Pub. Health, 379 Mass. 70, 74-76 (1979) (collecting cases); Levy v. Board of Registration Discipline in Medicine, 378 Mass. 519, 524-525 (1979) (dealing with 1975 medical malpractice statute). The hospitals urge that closer scrutiny should be given to the agency action in this case than in the usual case because c. 351’s division of responsibilities between the DPH and the board shows that the “Legislature has [not] granted broad agency authority [to the board] to deal with an entire area of activity.” Grocery Mfrs. of Am., supra at 75. Applying such closer scrutiny here,

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however, if that indeed is required, would not affect our analysis of the regulation’s validity. See id. at 75-76 (court upholds action by agency not granted broad authority to deal with entire area of activity).

The Challenged Regulations.[9]

1. 243 Code Mass. Regs. § 3.07 (3) (a).

This regulation places an “affirmative duty” on each health care provider to report “injuries and incidents” to the facility’s Patient Care Assessment Coordinator. It also places related employee training responsibilities on the hospitals.

The hospitals’ primary objection to § 3.07 (3) (a) is that it goes beyond the requirement of G.L.c. 111, § 203 (a), that hospital by-laws establish procedures for internal reporting of health care provider conduct that indicates incompetency or is inconsistent with good patient care. The hospitals also claim that by placing an “affirmative duty” on health care providers to report “injuries and incidents” to their Patient Care Assessment Coordinator, § 3.07 (3) (a) creates standards of care the breach of which could result in tort liability for health care providers or the hospitals. Similarly, the hospitals contend that the employee training aspects of § 3.07 (3) (a) will interfere with employment relations.

Given the deference paid to an agency’s interpretation of its statutory powers, the hospitals’ arguments are meritless. Even if it is assumed that § 3.07 (3) (a) requires more than G.L.c. 111, § 203 (a), the regulation is consistent with the statute. Se Grocery Mfrs. of Am., supra at 76. More importantly, the board’s determination that the internal reporting required by the regulation is a necessary component of the QPCAP, the risk management program the board must provide the hospitals, is reasonable. See Levy, supra at 525. That the regulation creates duties and possibly affects employment relationships,

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as many regulations do, is irrelevant to the board’s authority to promulgate the regulation.

2. 243 Code Mass. Regs. § 3.08.

This regulation requires that hospitals report specified “Major Incidents” to the board. 243 Code Mass. Regs. § 3.08 (1) — (3).

The hospitals state a number of objections to § 3.08. First, they claim the board lacks authority to promulgate it. Second, they argue that § 3.08 conflicts with the requirements of G.L.c. 111, § 53B (requiring hospitals to report curtailment of physician privileges to the board), and G.L.c. 112, § 5F
(requiring each health care provider to report to the board any person it reasonably believes has violated G.L.c. 112, § 5, or board regulations). Finally, the hospitals contend that requiring the major incident reports will undermine the protections provided to PRC activities by G.L.c. 111, § 204 (a) — (d).

The hospitals’ objections to 243 Code Mass. Regs. § 3.08, like the objections to § 3.07 (3) (a), are unpersuasive. First, the board’s power to issue § 3.08 is implicit in its power to provide hospitals with risk management programs. It is doubtful that the Legislature would charge the board with establishing such programs without also intending that the board be able to promulgate the necessary regulations. See Grocery Mfrs. of Am., supra at 75.

Second, § 3.08 is consistent with, not contrary to, G.L.c. 111, § 53B, and c. 112, § 5F. These statutes do not state, as the hospitals argue, exclusive circumstances in which board reports are required. As with § 3.07 (3) (a), the board’s determination that § 3.08’s requirement of major incident reports is necessary to the QPCAP is not unreasonable and therefore must be upheld. See Levy, supra at 525.

Finally, the hospitals’ argument that furnishing the board major incident reports will undercut the protections provided to PRC activities by G.L.c. 111, § 204 (a) — (d) (1986 ed.), overlooks that nothing in the regulation requires any PRC role in filing the reports. Presumably, the Patient Care Assessment Coordinator is responsible for a hospital’s compliance with the regulations. That the board will be reviewing the reports during

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the same period in which a PRC may be discussing the incidents in no way opens up the PRC “proceedings, reports and records” to the board.

3. 243 Code Mass. Regs. § 3.07 (3) (l).

This regulation requires hospitals to establish a system to provide “a reasonable and comprehensive evaluation of a licensee’s clinical skills, competence and judgment, upon request of and for filing with the Board.”

As with 243 Code Mass. Regs. § 3.08, the hospitals argue that the board has no authority to issue § 3.07 (3) (1), that it conflicts with G.L.c. 112, § 5I, which allows the board to request reports of results of given surgical or other medical procedures on a physician-by-physician basis, and that compliance with it will undercut the protections provided PRC activities by G.L.c. 111, § 204 (a) — (d). The hospitals also contend that this regulation improperly requires them to be the board’s expert on demand.

For the reasons discussed above in connection with § 3.08 the hospitals’ first three objections are overcome. The board’s authority to issue § 3.07 (3) (1) flows from its duty to provide risk management programs to the hospitals. The regulation is consistent with G.L.c. 112, § 5I‘s provision for requiring reports on a physician-by-physician basis, and does not require any PRC involvement in the evaluation, thus avoiding any possible transgression of G.L.c. 111, § 204 (a) — (d).

The hospitals’ argument that § 3.07 (3) (1) requires them to be the board’s expert on demand is off point. The cases relied on involve parties seeking to compel unwilling witnesses to provide expert testimony in adversary proceedings. See, e.g. Commonwealth v. Vitello, 367 Mass. 224, 235 (1975). The context of § 3.07 (3) (1) is the board’s information gathering and assessment of the QPCAP’s efficacy.

4. 243 Code Mass. Regs. § 3.07 (3) (k).

This regulation requires the hospitals to establish procedures whereby the DPH and board can “access and audit” the “[QPCAP] information and records during normal business hours.” As the hospitals note, because the QPCAP requires hospital action and information gathering in a number of areas,

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this regulation would give the board access to a wide variety of hospital records including those relating to quality assurance, risk management, and peer review (243 Code Mass. Regs. § 3.02); physician credentialing (243 Code Mass. Regs. § 3.05); incident reporting (243 Code Mass. Regs. §§ 3.07, 3.08); and patients’ records (243 Code Mass. Regs. § 3.10 [2]).

As with the other regulations, the hospitals have a number of objections to § 3.07 (3) (k). They argue that the board is without authority to issue § 3.07 (3) (k), and that the regulation conflicts with G.L.c. 112, § 5, which gives the board subpoena power to pursue records in the context of physician investigations. These arguments are again unpersuasive. The board’s authority to issue § 3.07 (3) (k) is implicit in its duty to provide risk management programs, and the regulation, so far as it is valid, is consistent with, not contrary to, G.L.c. 112, § 5.

The hospitals’ further arguments against § 3.07 (3) (k) are more troublesome. First, they contend that § 3.07 (3) (k) conflicts with provisions of G.L.c. 111, § 204 (a) — (d), protecting PRC activities in that the regulation would make PRC items available to the board outside the context of formal board investigations and proceedings.[10] Second, the hospitals argue that § 3.07 (3) (k) violates the general legislative scheme because the DPH, not the board, is given inspection and audit powers in G.L.c. 111 and because c. 351 contemplates board access to information only after other entities have made threshold determinations of possible physician malpractice.

We look to the Legislature’s intent as expressed in the plain language of the statute to determine whether § 3.07 (3) (k) conflicts with G.L.c. 111, § 204 (a) — (d). Section 204 (a) provides that PRC “proceedings, reports and records” are confidential and “shall not be subject to subpoena or discovery, or introduced into evidence, in any judicial or administrative proceeding, except proceedings held by the board of registration

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in medicine, and no person who was in attendance at a meeting of a medical peer review committee shall be permitted or required to testify in any such judicial or administrative proceeding, except proceedings held by the board of registration in medicine, as to the proceedings of such committee or as to any findings, recommendations, evaluations, opinions, deliberations or other actions of such committee or any members thereof.” Section 204 (b) and (c) provide that information available from other sources is not privileged simply because also submitted to a PRC. Finally, the last sentence of § 204 (b) states that the “provisions of this section [do not] apply to any investigation or administrative proceeding conducted by the board of registration in medicine.”

The hospitals argue that § 204 creates a strong PRC privilege which allows access to PRC items only when the board is conducting a formal investigation or disciplinary proceeding with regard to a physician pursuant to G.L.c. 30A.[11] The hospitals note that the statutory and regulatory references to board investigations all involve investigations of particular physicians pursuant to filed complaints. See, e.g., G.L.c. 112, § 5, first, second, seventh, and ninth pars. (1986 ed.); 243 Code Mass. Regs. § 1.03 (1) — (3) (1987). The hospitals’ basic point is that the plain meaning of the term proceedings as used throughout § 204 “is formal, adversarial proceedings against a particular party, . . . a Chapter 30A disciplinary proceeding against a specific licensee.”

The board contends that § 204 creates only a qualified privilege which should be narrowly construed. The board’s basic argument is that, in view of the more active role c. 351 assigns the board, the terms investigation and administrative proceeding as used in § 204 (a) and § 204 (b) create a broad

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exception to the PRC privilege, and the board’s determination that it needs open access to all QPCAP records, including PRC items, is reasonable. The board also argues that the past failure of PRC activities to reduce malpractice indicates that the Legislature could not have intended only narrow board access to PRC items.

A number of factors show that the board’s construction of the PRC privilege’s scope is unreasonable. The board’s approach reads the “investigation or [board] administrative proceeding[s]” language of the last sentence of § 204 (b) into § 204 (a), which refers only to board “proceedings,” supra, note 11, and concludes PRC items are available to the board in all its activities. The board makes no effort to justify this interpretational addition of words to § 204 (a).

On a more basic level, open-ended board access to PRC items is antithetical to the newly created PRC privilege. It does not seem reasonable that the Legislature would create a PRC privilege and through an exception undercut the confidentiality that that privilege allows. If the privilege was designed to do anything, it was designed to foster aggressive critiquing of medical care by the provider’s peers. An exception as broad as the board envisages frustrates this goal.

Other considerations show that the board’s construction of § 204 is unreasonable. First, § 204 (a)’s approach of establishing a broad privilege with only one exception indicates an element of exclusivity. When the board attempts to add to that exception through § 3.07 (3) (k), the regulation conflicts with rather than conforms to the statute. Compare, supra, discussion of other challenged regulations’ conformity with statutes. Second, when the board argues that PRC activities have failed to reduce malpractice in the past, it overlooks the fact that such activities were never before privileged. See Cronin v Strayer, 392 Mass. 525, 532 (1984). Further, reading the exception to the privilege narrowly is consistent with our cases where we have refused to add to the listed exceptions to a given statutory privilege. Petition of Catholic Charitable Bureau of the Archdiocese of Boston, Inc., to Dispense with Consent to Adoption, 392 Mass. 738, 742 (1984).

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That § 3.07 (3) (k) is invalid to the extent it authorizes board access to PRC “proceedings, reports and records” does not entirely invalidate the regulation. Board access to all other information generated by the QPCAP system in no way would violate the PRC privilege and is within the board’s authority implied from its statutory responsibility to provide the QPCAP. Thus, the hospitals should make available to the board all incident reports, patient complaints, employee training materials, credentialing items, Patient Care Assessment Coordinator reports, and other items they are charged with generating. Reviewing these items will assist the board in overseeing and improving the risk management program it provides the hospitals. It is only where the board seeks PRC “proceedings, reports and records” that § 204’s PRC privilege stands in the way.[12] Section 204 promotes the uninhibited expression of professional opinions before a PRC and protects the PRC’s work product. Section 204 does not protect information generated by other components of the QPCAP system or the “raw materials” relied on by a PRC if obtained from other sources. See G.L.c. 111, § 204 (b), (c) (1986 ed.).

The hospitals also argue that § 3.07 (3) (k) is invalid because it conflicts with c. 351’s over-all scheme. If true this would prevent access to the QPCAP generated information which is not covered, as noted above, by § 204’s protection of PRC “proceedings, reports and records.” The argument is, however, easily addressed. That the Legislature has given hospital inspection powers to DPH — G.L.c. 111, §§ 53, 54 — does not prevent the board from reasonably determining that “access and audit” of QPCAP items is necessary to fulfilling its mandate of providing risk management programs to hospitals. The regulation does not empower general inspection of hospital facilities as a condition of licensure; that is the DPH’s province.

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The regulation only allows DPH and board review of QPCAP generated files.

Similarly, that statutes require reports to the board after a number of entities make preliminary determinations of possible malpractice in no way prevents the board from seeking information concerning the QPCAP. The statutorily required information implicates the board’s disciplinary powers, whereas the information reviewed under § 3.07 (3) (k) allows the board to assess the QPCAP on a continuing basis.

5. 243 Code Mass. Regs. § 3.04.

This regulation seeks to maintain the confidential status of PRC and PRC-related items which the board expects to receive under the QPCAP regulations. To the extent that the board cannot obtain PRC “proceedings, reports and records” under the above analysis of § 3.07 (3) (k), the contest over § 3.04 is moot. Section 3.04 does, however, speak of designating as confidential items related to PRC activities. The validity of such action is not clear, given the statutory definition of public records contained in G.L.c. 4, § 7, cl. 26. Items related to PRC records, unlike PRC “proceedings, reports and records” themselves, would not seem to fit exemption (a) of G.L.c. 4, § 7, cl. 26 (items exempted from disclosure by statute). Where, however, no particular designation of “related to” items as confidential is currently at issue between the parties, we need not reach the alleged controversy over § 3.04. See Grocery Mfrs. of Am., supra at 77.

Conclusion.

In sum, a judgment is to enter declaring that 243 Code Mass. Regs. §§ 3.07 (3) (a), 3.08, and 3.07 (3) (1) are validly promulgated pursuant to the board’s power to provide risk management programs to hospitals, are consistent with, not contrary to, existing statutes, and do not impinge on G.L.c. 111, § 204‘s PRC privilege. The judgment shall also declare that § 3.07 (3) (k), in contrast, does conflict with the PRC privilege to the extent it seeks access to PRC “proceedings, reports and records.” This analysis of § 3.07 (3) (k) eliminates the alleged controversy over § 3.04.

So ordered.

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243 Code Mass. Regs.

3.04: Confidentiality of Records and Information

(1) To promote free and full compliance with the reporting
requirements set forth below, which will enhance the protection
of the public, information and records both generated pursuant to
these regulations and which relate to the functions of a “Medical
Peer Review Committee” (as defined by M.G.L.c. 111, s. 1), are
hereby deemed confidential and, to the extent allowable under
M.G.L.c. 111, s. 204, not subject to subpoena, discovery or
introduction into evidence.

(2) To protect the confidentiality of information and records
both generated pursuant to these regulations and which also
relate to the functions of a “Medical Peer Review Committee” (as
defined by M.G.L.c. 111, s. 1) and to assure that this
information and these records are not subject to subpoena,
discovery or introduction into evidence, the Patient Care
Assessment Coordinator may designate such information and records
as “proceedings, reports and records of a medical peer review
committee,” within the meaning of M.G.L.c. 111, s. 204(a).

(3) Information and records so designated by the Patient Care
Assessment Coordinator pursuant to the paragraph above may be
maintained or utilized by the Board of Registration in Medicine,
including but not limited to its Data Repository and its
Disciplinary Unit, in its investigations or its other
proceedings. Such information and records maintained or utilized
by the Board shall remain confidential and not subject to
subpoena, discovery or introduction into evidence, consistent
with M.G.L.c. 111, s. 204. However, such information and records
may not remain confidential if disclosed in an adjudicatory
proceeding, but the information and records shall be otherwise
subject to any protections provided by M.G.L.c. 111, s. 204.

(4) The provisions in this section shall not apply to
“proceedings, reports and records of a medical peer review
committee,” within the meaning of M.G.L.c. 111, s. 204(a), if
such proceedings, reports or records are obtained from a source
independent of a Medical Peer Review Committee.

3.07: Qualified Patient Care Assessment Program — Internal
Audits and Internal Incident Reporting

. . . .

(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

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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, s. 70E.

. . . .

(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.

3.08: Qualified Patient Care Assessment Program — Major
Incident Reporting to Board of Registration in Medicine.

(1) Introduction. The establishment by health care facilities
of focused occurrence and occurrence screening criteria is
designed to facilitate the generation of internal institutional
incident reports and to assist in the analysis of specific
incidents and patterns at the health care facility. In addition,
to permit the Board to conduct its own timely assessment of those
major incidents that may represent the most severe adverse
patient outcomes, there is a necessity for reporting such major
incidents directly to the Board by each health care facility.
These reportable major incidents will consist, initially, of two
types of events. First, there will be reporting of a small number
of specified outcomes without regard to the underlying
circumstances (Category I “Major Incidents”). The second, broader
category of incidents reportable to the Board consists of severe
adverse outcomes when analysis indicates that the outcome fell
outside the realm of generally accepted and expectable results,
taking into account the nature of the underlying disease process
and the recognized risks and benefits of the appropriate medical
response to it (Category II “Major Incidents”). An event may fall
into this second category solely by virtue of its rarity as a
natural outcome of the disease or intervention and inclusion in
this category explicitly does not presuppose either that the
outcome was preventable or that it resulted from substandard
medical practice. The Board plans to assess the yield of these
two separate types of reportable major incidents to determine
whether one or the other approach is more useful in identifying
potentially preventable adverse outcomes and will, on the basis
of such assessment, work with

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health care facilities and licensees to expand or refine the
contents of the two categories of reportable major incidents.

(2) The following “reportable major incidents” must be reported
by the health care facility to the Board:

(a) Category I incidents:

1. Maternal deaths which are related to delivery.

2. Fetal deaths. A “fetal death,” as defined by
M.G.L.c. 111, s. 202, means death prior to the
complete expulsion or extraction from its mother of a
fetus, irrespective of the duration of pregnancy, as
indicated by the fact that after such expulsion or
extraction the fetus does not breathe or show any
other evidence of life such as beating of the heart,
pulsation of the umbilical cord, or definite movement
of voluntary muscles. “Fetal death” does not include
an abortion as defined in M.G.L.c. 112, s. 12K.

3. Chronic vegetative state resulting from medical
intervention.

4. Death in the course of or resulting from
ambulatory surgical care.

(b) Category II incidents: major or permanent impairments of
bodily functions or deaths that are not ordinarily expected as
foreseeable results of the patient’s condition or of
appropriately selected and administered treatment.

(3) Health care facilities shall file major incident reports
with the Board on a quarterly basis. The major incident report
shall contain, for each major incident, the name of the licensee,
the license number, a brief description of the major incident,
and, if any, results of an internal investigation and corrective
measures. In the case of reporting fetal deaths, the health care
facility may discharge its reporting obligations under this
section by filing with the Board the form prescribed by the
Department of Public Health pursuant to M.G.L.c. 111, s. 202,
with the names of the parents excluded. In lieu of providing the
names of the licensees and the license numbers, the health care
facilities may provide unique coded identifiers, pursuant to a
Statewide Coded Identifier System, provided that such a Statewide
Coded Identifier System is approved by majority vote of the
Board.

(4) This section 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, s. 53B, and
regulations related thereto.

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