By Thomas Allen, M.D.
[Winter 2002; Vol. 28, No. 2; Pg 9-10]
In May 2001 the MedChi House of Delegates adopted a resolution that called for the society President, Dr. Blumberg, to appoint a Task Force on Medical Discipline and Quality Assurance. It was prompted in part by the fact that this year the Maryland legislature is required to conduct a decennial sunset review of the legislation originally creating the Board of Physician Quality Assurance (BPQA). I was asked to chair the task force. Dr. Michael Spodak, chair of the MPS Peer Review Committee, was an important member of that task force. The task force met twice and reviewed a large amount of literature and relevant information and drafted a twelve-page document that is available from MedChi for anyone interested. The conclusions of the report are in many ways a revolutionary new way of looking at medical errors and discipline using the most advanced concepts and data that we have available. It comes at a time when the BPQA, MedChi, and MPS role in this process is being questioned by the local newspaper and the legislature in a culture of blame and finger-pointing.
To paraphrase Albert Einstein, explanations should be as simple as possible, but not simpler. However, he did not understand media requirements. For example, the papers have had a field day with Sidney Wolfe’s criticism that based on state licensing Boards’ actions, Maryland ranks 40th in 1999 performance. But there is no mention that Massachusetts ranks 39th, Minnesota 48th and DC 41st, while Alaska is 1st, N. Dakota 2nd and Wyoming 3rd. Where would Wolfe or others rather get their care? Pages 7- 8 in the report deal quite directly with the flaws in the numbers that Wolfe and others use. If, for example, one calculates actions based on breaches of the standard of care and use figures for practicing physicians only, Maryland is 3rd, behind Colorado and Florida.
There is no doubt that medical errors happen and that it is important to prevent them. The Institute of Medicine reported that medical errors in American hospitals kill between 44,000 and 98,000 persons a year. The New York Times further dramatized the number by comparing it to the crash of three fully loaded jumbo jets every other day. The task force recognized that the Institute of Medicine figures can be disputed. They have been criticized both by Dr. Gershen in Maryland Medicine (Summer, 2000) and more recently by Drs. Hayward and Hofer in the Journal of the American Medical Association (July 25, 2001). Although the magnitude of the Institute of Medicine figures may be in dispute, there is no dispute that errors happen. It is in the interest of the public and physicians to provide a way of determining the true magnitude of this problem, and to develop means to reduce those events. There are now models in other industries for doing this, e.g. the airline industry. Moreover, the analysis of such disasters as Three Mile Island, Chernobyl, and the Challenger show, as Studdert and Brennan (JAMA, v.286, 2001) have said, ‘latent’ errors in the design of complex systems are an important predictor of accidents. ‘Active’ errors made by frontline operators often play a role, but these are typically of secondary importance in the chain of causation.” One of the problems in getting this information is, as the Institute of Medicine report suggests, the “culture of blame” in the form of malpractice suits and medical discipline. It puts those “frontline operators” in a defensive position with their personal attorney the only “safe” person to talk to about it because he or she will divulge nothing contrary to the interest of the doctor or institution.
A study by Localio, et. al. in the New England Journal of Medicine, (1991) did a retrospective chart review of a random sample of 31,429 patients hospitalized in New York State in 1984. They revealed, using two physicians and their criteria, that about 1% of hospital discharges showed adverse events caused by negligence. Of this number only 1-2% lead to malpractice claims. They draw two important conclusions: 1) “Our data reflect a tenuous relation between proscribed activity and penalty and thus are consistent with the view that malpractice claims provide only a crude means of identifying and remedying specific problems in the provision of health care” and, 2) “Unless there is strong association between the frequency of claims and that of negligence, the rate of claims alone will be a poor indicator of quality.” This study suggests that most errors do not result in suits, even for negligence, and probably go unrecorded anywhere, and, quite possibly, unaddressed. And that does not even account for the errors or adverse events where negligence is not even a consideration.
Brennan, et. al. in the NEJM (December 26, 1996) looked at 51 litigated malpractice claims over a ten-year period independently reviewed. They found that “10 of 24 that we originally identified as involving no adverse event were settled for the plaintiffs...as were 6 of 13 cases classified as involving adverse events but no negligence...and 5 of 9 cases in which adverse events due to negligence were found in our assessment...In a multivariate analysis disability (permanent vs. temporary or none) was the only significant predictor of payment.” In other words whether an adverse event occurred or not, and whether it was caused by negligence or not, had no statistical bearing on the outcome. It basically calls into question the whole process of finding fault and the culture of blame, and certainly raises significant concerns about whether our current system that is complaint-driven gives any real protection, or safety, to the public that relies on it. We are proposing a different one and a system we believe will better serve the profession and the public.
The recommendations of the task force are summarized below:
1. MedChi should pursue legislative and other action to lead Maryland into the forefront of the patient safety movement by advocating the creation of a new system of regulation and discipline for physicians that embraces the tenets of the Institute of Medicine reports, ‘To Err is Human’ and ‘Crossing the Quality Chasm’. The goal of the system should be to achieve meaningful improvements in the quality of health care delivered in the state, year after year, and its prevailing philosophy should be non-punitive in nature. The new system should contain at least the four essential elements described in this report, summarized as follows:
(a) Implementing comprehensive physician reporting of standard of care related adverse events, in a framework of incentives and protections as described, and using national protocols now in development as guidelines for the nomenclature and taxonomy of such reporting;
(b) Creating a process for receiving adverse events data systematically and analyzing them to identify problem situations, to assess problem situations for root cause, to formulate interventions for corrective action, and to implement and monitor interventions;
(c) Establishing that physician cooperation and communication with a reporting process including intervention into a physician’s practice, would not be discipline, and would be confidential and non-discoverable, such that sanctions for standard-of-care-related issues would result only if there is a failure of a physician to communicate with and cooperate with the process;
(d) Establishing specifically that an individual adverse event could not become the basis for a sanction if it is reported voluntarily pursuant to the reporting regime.
MedChi should work with appropriate State agencies, including the BPQA, Department of Health and Mental Hygiene, and Maryland Health Care Commission, to elaborate further the structure, functions and financing for a system, and to implement the approach outlined herein, using MHCC’s existing statutory schedule which calls for an interim report to the General Assembly in January 2002 and a final report with recommendations for implementation in January 2003 and at no additional cost to physicians.
MedChi should vigorously defend, and oppose changes to the current BPQA structure for physician discipline in Maryland, and specifically MedChi’s peer review role in it, pending legislative adoption and implementation of a plan that is consistent with the task force's recommendations, and subject to recommendation #4 below.
MedChi should advocate eliminating the current MedChi role in the balloting process by which a list of names is submitted to the Governor for selection of physician members of the BPQA.
References available upon request.
Dr. Allen is chair of the MedChi Task Force on Medical Discipline and Quality Assurance.