Beth Israel Hosp. Ass'n v. Board of Registration in Medicine

Decision Date14 September 1987
PartiesBETH ISRAEL HOSPITAL ASSOCIATION et al. 1 v. BOARD OF REGISTRATION IN MEDICINE.
CourtUnited States State Supreme Judicial Court of Massachusetts Supreme Court

Gerald Gillerman (Gordon P. Katz, Boston, and William M. Mandell, Newton Center, with him) for plaintiffs.

James M. Shannon, Atty. Gen. (Carolyn V. Wood, Asst. Atty. Gen., with him) for defendant.

Harold J. Bressler, Chicago, Ill. and Richard A. Johnston, Boston, for Joint Com'n on Accreditation of Hospitals.

Patrick R. Carroll, Burlington, William T. McGrail, Clinton, and Dorothy Grandolfi Wagg, Burlington, for Massachusetts Hosp. Ass'n, Inc.

Alfred Miller, Peter N. Greenwald, New York City, and Joan S. Wise, for American Ass'n of Retired Persons.

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

Before HENNESSEY, C.J., and WILKINS, LIACOS, ABRAMS and LYNCH, JJ.

HENNESSEY, Chief Justice.

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, 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, with 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.

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 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)(l ), 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)(l ), 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, 393 N.E.2d 881 (1979) (collecting cases); Levy v. Board of Registration & Discipline in Medicine, 378 Mass. 519, 524-525, 392 N.E.2d 1036 (1979) (dealing with 1975 medical malpractice statute). The hospitals urge that closer scrutiny should be paid 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 379 Mass. at 75, 393 N.E.2d 881. Applying such closer scrutiny here, however, if that indeed is required, would not affect our analysis of the regulation's validity. See id. at 75-76, 393 N.E.2d 881 (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. See Grocery Mfrs. of Am., supra at 76, 393 N.E.2d 881. 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 378 Mass. at 525, 392 N.E.2d 1036. That the regulation creates duties and possibly affects employment relationships, 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 379 Mass. at 75, 393 N.E.2d 881.

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 378...

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