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System and Responsibility: Three Readings of the IOM Report on Medical Error

Published online by Cambridge University Press:  24 February 2021

Extract

The most publicized finding of the Institute of Medicine (IOM) report is that between 44,000 and 98,000 patients die each year as a result of “adverse events” in medical care. The core concern of the report is to argue that a "systems" approach to medical practice holds out considerable promise for the elimination of the subset of those “adverse events” which are the result of medical error. The report outlines the “systems” approach and proposes various public policies which might encourage the adoption of that approach, enhance its effectiveness and protect it from potentially undermining legal assaults.

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Articles
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Copyright © American Society of Law, Medicine and Ethics and Boston University 2020

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References

1 There is considerable dispute over the accuracy of these numbers. The former number is based on a study conducted in New York and the latter on a Colorado and Utah study. See Brennan, Troyen A., The Institute of Medicine Report on Medical Errors - Could It Do Harm?, 342 New Eng. J. Med. 1123, 1123 (2000)CrossRefGoogle Scholar (discussing the impact of the IOM report on the health care industry).

2 See Committee on Quality of Health Care in America, Institute of Medicine, To Err is Human: Building A Safer Health System (Linda T. Krohn et al. eds., 2000) [hereinafter Too Err is Human].

3 See id.

4 See id.

5 The IOM's terminology is sometimes obscure. For the sake of brevity in the main text, however, I shall for the most part raise terminological issues only in footnotes.

6 See Brennan,supra note 1, at 1123.

7 To Err is Human,supra note 2, at 28. Adverse events, however, do not split as sharply as the IOM Report's classifications of those caused by “underlying condition[s]” and those caused by “medical management.” For example, suppose that a physician negligently fails to diagnose a cancer, with the result that, undetected, it metastasizes, causing the patient to die young. The injury to the patient (early death) is clearly the result of the underlying condition (cancer), but it is also clearly the result of medical mismanagement (negligent failure to diagnose). The patient's death should surely count as an adverse event, but was it caused by medical (mis)managementrather than by cancer?

8 Id.

9 See id.

10 See id. at 55.

11 See Brennan,supra note 1, at 1125.

12 Id. at 28. The set of definitions just laid out do not fit comfortably together. Consider the example suggested by Troyen Brennan: A patient with no prior history of allergies has an allergic reaction to an antibiotic. Such a reaction could have been avoided if every patient were routinely pre-tested for allergies, but the incidence of allergic reaction is so rare, and testing sufficiently expensive, that the routine use of such testing is clearly cost-prohibitive. Brennan,supra note 1, at 1123-25. The allergic reaction is surely an “adverse event,” but was it the result of “error” because, at some cost, it might have been prevented?See id. It seems most attractive to place the allergic reaction into the category of non-negligent medical error—a theoretically preventable adverse event that resulted from physician behavior entirely within the standard of care.See id. But, we might ask, in what sense does it constitute “error in execution” to act consistently with a plan that has correctly eliminated routine allergy-screening as non-cost-effective? To what extent does making such a plan amount to an “error in planning"? If there is no error in execution and none in planning, then does the adverse event not count as medical error? And yet it was an injury caused by medical management, rather than by the underlying condition of the patient—and was preventable, too.

One problem here is with the failure to define (or confine) the concept of preventability. Every adverse event—every injury caused by medical management rather than by the patient's underlying illness—is theoretically preventable at some cost.See id. Exercise more care! Do another test! Develop a software program to keep better track of patient medications! Build individual pods for all inpatients, to eliminate any chance of their catching flu from one another! Depending upon the level of resources you imagine being invested, a very large number of medical-management injuries emerge as preventable, and therefore as the result of error.See id.

Of course, the IOM might wish to take the other tack, and declare that adverse events resulting from proper execution of plans grounded in sound cost-benefit analysis are not the result of medical error at all. But then it would have to admit that when it defines an instance of medical error as the occurrence of a “preventable adverse event,” it really means a “reasonably preventable adverse event"—an adverse event preventable at reasonable cost, with the exercise of reasonable care. This translates the question, “how many medical errors can we prevent” into the question, “what resources are we willing to expend to prevent medical errors.”

13 To Err is Human,supra note 2, at 49.

14 Id. at 52.

15 Id. at 55.

16 Id.

17 Id.

18 This is a shortened version of the example cited in To Err Is Human,supra note 2, at 50-51. The example is discussed on pp. 50-56.

19 See id. at 4.

20 See id. at 56 (discussing how all of these factors may be considered “latent failures”).

21 See id. at 55.

22 Id.

23 Frederick Winslow Taylor, The Principles of Scientific Management 7 (1911).

24 I shall, however, be referring to “managed care” in the sense of the “managed care health insurance industry” below. I generally share the view of Hacker & Marmor that the term “managed care” is so vague and politics-laden as to be of little use in discriminating among contemporary health-insurance plans.See generally Hacker, Jacob & Marmor, Theodore R., The Misleading Language of Managed Care, 24 J. Health Pol., Pol'Y & L. 1033 (1999)CrossRefGoogle Scholar (arguing that the term “managed care” is highly confusing and suffers from severe incoherence). By “managed care” and “the managed care industry” below I shall mean nothing less general than “any institutional arrangement for the delivery of healthcare that involves active and sustained attempts by payors to influence and control the cost and quality of the healthcare for which they pay.” Even Hacker & Marmor seem to recognize the utility of the term in signaling the broad historical change away from the uncontrolled and unmonitored fee-for-service healthcare delivery systems that prevailed in mid-twentieth century America.See id. at 1036.

25 See generally Taylor,supra note 23 (arguing the need for greater national efficiency achieved by implementing a single standard of management rather than allowing each employee to use his best judgment).

26 For discussions of Taylor's scientific management approach, see Reinhard Bendix, Work and Authority in Industry: Ideologies of Management in The Course of Industrialization 274-81 (1956); Charles Perrow, Complex Organizations: A Critical Essay 56-58 (3rd ed. 1986); w. Richard Scott, Organizations: Rational, Natural and Open Systems 36-37 (2nd ed. 1987) [hereinafter Organizations]. For a readable contemporary account of Taylor's life, and of his vast influence on the American economy and psyche, see Robert Kanigel, The One Best Way: Frederick Winslow Taylor and The Enigma of Efficiency (1997).

27 See Kanigel,supra note 26, at 489; Frank B. Gilbreth,Hospital Efficiency From the Standpoint of the Efficiency Expert, in Efficiency, Scientific Management, and Hospital Standardization: An Anthology of Sources 134 (Edward T. Morman ed., 1989); Charles D.. Wrege,Medical Men and Scientific Management: A Forgotten Chapter in Management History, Rev. of Bus. & Econ. Res., Spring 1983, at 38, 38-39; Wrege, Charles W., The Efficient Management of Hospitals: Pioneer Work of Ernest Codman, Robert Dickenson, and Frank Gilbreth, 1910-1918, in Academy of Management Proceedings 114-18 (1980)CrossRefGoogle Scholar.

28 See Taylor,supra note 23, at 11-12.

29 Id. at 12.

30 See id. at 13.

31 See id. at 14-15.

32 See id. at 15-16.

33 Id. at 36-37.

34 Bendix,supra note 26, at 276 (quoting testimony of Frederick W. Taylor before theSpecial House Committee to Investigate the Taylor and Other Systems of Shop Management).

35 See Taylor,supra note 23, at 26.

36 See id.

37 See id. at 104. “Now, among the various methods and implements used in each element of each trade there is always one method and one implement which is quicker and better than any of the rest. And this one best method and best implement can only be discovered or developed through a scientific study and analysis of all of the methods and implements in use, together with accurate, minute, motion and time study. This involves the gradual substitution of science for rule of thumb throughout the mechanic arts…. [I]n most cases [it is] impossible for the men working under [current] systems to do their work in accordance with the rules and laws of a science or art, even where one exists…. [I]n almost all of the mechanic arts… the workman who is best suited to actually doing the work is incapable of fully understanding this science….”Id. at 25-26.

38 See Kanigel,supra note 26, at 514-18.

39 Frederick Winslow Taylor, Scientific Management 211, 189 (1947),quoted in Scott,supra note 26 at 36.

40 Neil Postman, Technopoly: The Surrender of Culture to Technology 52 (1992).

41 See James C. Robinson, The Corporate Practice of Medicine: Competition and Innovation in Health Care 106 (1999) (discussing utilization review mechanisms whereby nurses employ clinical protocols to the exclusion of all other methods in order to find a solution for the patient).

42 Protocols specify the care to be provided to a patient undergoing a particular treatment; protocols “are strict management directives and are more binding than clinical guidelines.” Plocher et al.,Care Management and Clinical Integration Components, in Essentials of Managed Healthcare, 179 app. at 194 (Peter R. Kongstvedt ed., 4th ed. 2001) [hereinafter Essentials]. Guidelines are “systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical conditions.”Id. at 195. Pathways are “optimal sequencing and timing of interventions by physicians, nurses, and other staff for a particular diagnosis or procedure [and are] designed to minimize delays, resource utilization, and unit costs and to maximize the quality of care.”Id. at 195.

43 See Robinson,supra note 41, at 106 (“These utilization review mechanisms, typically involving nurses armed with clinical protocols, can deny authorization for a procedure…. Practicing physicians loathe what they consider a top-down system of controlling care that is not sensitive to their patients' particular conditions.”).

44 See, generally, Peter R. Kongstvedt, et al.,Using Data and Provider Profiling in Medical Management, in Essentials,supra note 42, at 379-18.

45 See, e.g., Barbara Martinez,Aetna Tries to Improve Bedside Manner in Bid to Help Bottom Line, Wall St. J., Feb. 23, 2001, at Al (“Many doctors disparage … Aetna's much-derided rule requiring doctors to call Aetna for permission to perform elective surgery and many other medical procedures... as “Mother, may I” medicine.”).

46 See id.

47 See John E. Wennberg, The Dartmouth Atlas of Health Care in The United States 2 (1996) (“The existence of variation raises a number of important issues. Foremost is the question “Which rate is right?"… Learning which rate is right requires learning what informed patients want.”)

48 Against this claim we may find a medical literature asserting the counter-claims that medical treatment must of necessity respond to individual cases uniquely, and not be governed by the blanket generalizations of disease-theory; that medicine is as much a humanist as a scientific pursuit; and therefore that no amount of scientific knowledge in the hands of management can substitute for the good judgment of an experienced and humane physician in a particular case.See generally Eric J. Cassell, The Nature of Suffering and The Goals of Medicine (1991). This position leaves open the question whether scientific knowledge in the hands of management can substitute for the mediocre judgment of an experienced but not very talented physician, or for the untutored judgment of a humane and talented but inexperienced physician—and the crucial question of how many physicians are of which type.

49 See Taylor,supra note 23, at 36-37.

50 See Robinson,supra note 41 at 83-84 (“PPO insurers and network HMOs now divide the private health insurance market between them, having squeezed out most traditional indemnity insurers and staff-model plans, and are making significant inroads into the public Medicare and Medicaid programs.”).

51 Id. at 83.

52 Id.

53 See id.

54 Russell Korobkin,The Efficiency of Managed Care “Patient Protection” Laws: Incomplete Contracts, Bounded Rationality and Market Failure, (IGPA Working Paper No. 68, 1998)at http://www.igpa.uillinois.edu/publications/pdf/patientProtection.pdf (visited Mar. 25, 2001). “Consequently, HMOs tend to rely relatively less on direct utilization review and the threat of deselection than do Preferred Provider Organizations (PPO's), which tend to have broader, more loosely controlled networks of physicians.Id. at n. 69.

55 See Robinson,supra note 41, at 112-13 (discussing how responsibility for non-specialized tasks in some group practices has shifted from physicians to non-physician staff members).

56 See Taylor,supra note 23, at 39 (“[W]henever the workman succeeds in doing his task right, and within the time limit specified, he receives an addition of from 30 per cent, to 100 per cent, to his ordinary wage.”).

57 For a basic overview of current bonus schemes,see Stephen R. Latham,Regulation of Managed Care Incentive Payments to Physicians, 22 Am. J. L. & Med. 399, 400-07 (1996). For an up-to-date account of complex hybrid fee-for-service and capitation payment schemes,see Robinson, supra note 41, at 139-44.

58 See Lathan,supra note 57, at 408.

59 See Taylor,supra note 23, at 37.

60 On the structure of management in contemporary managed care organizations,see Kongstvedt et al.,supra note 44, at 63-70.

61 “Almost by definition, managed care plans will have a medical director…. The medical director usually has responsibility for provider relations, provider recruiting, Q[uality] Management], untilization management, and medical policy.”Id. at 66.

62 This single sentence is a hopelessly swift summary of “Organizations as rational systems,” chapter 2 of Scott,supra note 26, at 31-50, which is itself a swift summary of the theories it treats. The division here of organizational theories into the categories “rational,” “natural” and “open,” and the placement of individual theorists within those categories, follows Scott.

63 Id. at 31.

64 See id. at 51-75 (chapter 3, “Organizations as natural systems”).

65 The word “cybernetic” is more off-putting than it need be. A household heating system that includes a thermostat is a cybernetic system; it can detect and respond to its own outputs in light of previously specified standards.

66 See Scott,supra note 26, at 93.

67 See id. at 96.

68 See id.

69 See id. at 97. Thompson's view is that “organization will attempt to seal off their technical level, protecting it from the external uncertainties to the extent possible. The institutional level … must be open to the environment. It is at this level, where the environment must be enacted or adapted to, that the open system perspective is most relevant.”Id.

70 See id.

71 See id.

72 See To Err is Human,supra note 2, at 18-20.

73 See id. at 4-5.

74 See id. at 86-108.

75 See id. at 78.

76 See id. at 69.

77 See Aristotle, Politics § I, ch. VI, 12 (James Edward Cowell Welldon trans., The Macmillan Company 2d ed. 1888) (1883).

78 See To Err is Human,supra note 2, at 49 (explaining that blame should be placed on the system, not people).

79 See id.

80 Id.

81 Samuel Butler, Erewhon or Over The Range 114 (Hans-Peter Breuer & Daniel F. Howard eds., Assoc. Univ. Presses, Inc. 1981) (1872).

82 See Immanuel Kant, The Conflict of The Faculties 31-33 (Mary J. Gregor trans., Abaris Books, Inc. 1979) (1798).

83 See James C. Mohr, Doctors and The Law: Medical Jurisprudence in Nineteenth-Century America 109-21(1993).

84 See generally Barry R. Furrow Et Al., Health Law: Cases, Materials, and Problems 264-78 (2nd ed. 1997).

85 See to Err is Human,supra note 2, at 1 (“More people die in a given year as a result of medical errors than from motor vehicle accidents (43,458), breast cancer (42,297), or AIDS (16,516).”).

86 See id.

87 See id.

88 See id.

89 See id. at 109-31.

90 Id. at 109-31 (appearing in chapter 6, “Protecting Voluntary Reporting Systems from Legal Discovery”). Note that the IOM Report seeks to shelter only voluntary reporting schemes from discovery. The report recommends voluntary reporting schemes for adverse events that result in “near misses” or very minor injuries. The report does not seek to shield mandatory error reporting— reporting involving adverse events that caused serious injuries or death—from discovery, though it does seek to delay its release until medical investigation is complete and facts are accurate. This set of recommendations seems to represent a political compromise between committee members who favored protecting data about serious injury and death in order to facilitate reporting, and members who felt that where serious injury or death was concerned, public accountability demanded access to data.Id. at 110.

91 See generally To Err is Human,supra note 2, at 109-31 (discussing the protection of voluntary reporting systems from legal discovery).

92 See generally Butler,supra note 81 and accompanying text.

93 Alan M. Dershowitz, The Abuse Excuse (l 994).

94 Of course, not all theories of positive law seek their justification in morality.

95 See Kant,supra note 82, at 31-33.

96 For one account of this transformation,see Alan Brudner, The Unity of The Common Law 153-71 (1995).

97 See To Err is Human,supra note 2, at 169.

98 Id. at 169.

99 id.

100 See id.

101 See id.

102 Ralph Waldo Emerson,Ode, in Selections From Ralph Waldo Emerson 439-42 (Stephen Whichered., 1960).

103 To Err is Human,supra note 2, at 144-45 (noting that anesthesiology has seen a reduction in mortalities as a result of technological changes, information-based strategies, human-factors considerations, the networking of physician nurses and manufacturers, and effective leadership).

104 See id. at 71-73 (demonstrating how system safety has evolved within the aviation field, from the incorporation of safety during planning in World War II, through the development of human factors engineering during the 1950s and 1960s).

105 See id. at 159-60 (discussing how DuPont and Alcoa, Inc. maintain low rates of injury: DuPont implements a non-punitive system to encourage employees to report near-miss incidents and Alcoa systematically tracks, records, and even publishes date concerning accidents and the company's performance).

106 See id. at 160-62 (The four Navy strategies are: “the prioritization of safety as a goal, high levels of redundancy, the development of a safety culture that involves continuous operational training, and a high-level organizational learning”).

107 This is the sense of Kant's statement that “from a practical point of view every agent must presuppose his will to be free.” Immanuel Kant, Groundwork of The Metaphysic of Morals 42 (H.J. Paton trans., 1964).

108 See Emerson,supra note 102, at 441.

109 See Winslade, William J., Confronting Traumatic Brain Injury 154-56, 182-200 (1998)Google Scholar (characterizing brain injury as among the most serious public health problems facing the developed world, and recommending systemic safety enhancements including changes in the legal driving age, alteration to building codes regarding handrail design, redesign of highways, taxation of unsafe cars, public service campaigns addressing alcohol consumption by seniors, reduction of social dependence upon automobiles, segregation of surfing from swimming on public beaches, and complete banning of lawn darts, boxing and gun ownership).