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Institute of Medicine (US) Committee to Design a Strategy for Quality Review and Assurance in Medicare; Lohr KN, editor. Medicare: A Strategy for Quality Assurance: Volume 1. Washington (DC): National Academies Press (US); 1990.
Institute of Medicine (US) Committee to Design a Strategy for Quality Review and Assurance in Medicare; Lohr KN, editor.
Since the passage of Medicare legislation in 1965, Section 1861 of the Social Security Act has stated that hospitals participating in the Medicare program must meet certain requirements specified in the act and that the Secretary of the Department of Health and Human Services (DHHS) may impose additional requirements found necessary to ensure the health and safety of Medicare beneficiaries receiving services in hospitals. On this basis, the Conditions of Participation, a set of regulations setting minimum health and safety standards for hospitals participating in Medicare, were promulgated in 1966 and substantially revised in 1986. This chapter, in response to the congressional request, discusses the adequacy of the federal Conditions of Participation for hospitals in assuring quality of care. Limitations of the accreditation and certification methods are reviewed and recommendations are set forth for strengthening the Conditions of Participation program.
Since 1965, under authority of Section 1865 of the Social Security Act, hospitals accredited by the Joint Commission on the Accreditation of Healthcare Organizations (Joint Commission) or the American Osteopathic Association (AOA) have been automatically “deemed” to meet all the health and safety requirements for participation except the utilization review requirement, the psychiatric hospital special conditions, and the special requirements for hospital providers of long term care. As a result of this deemed status provision, most hospitals participating in Medicare do so by meeting the standards of a private body governed by representatives of the health providers themselves (i.e., the Joint Commission or the AOA). Both the federal conditions and the Joint Commission standards also require hospitals to be licensed by their states. (A more detailed discussion of the Conditions of Participation and deemed status is provided in Volume II, Chapter 7, from which much of the information in this chapter was taken. Options covering the Conditions of Participation program, and their respective implications, considered by the committee in developing its conclusions on the certification and accreditation of hospitals are delineated in the Volume II chapter.)
The Joint Commission is a private nonprofit organization governed by a board with 21 representatives of hospital and medical associations and 3 public representatives. The American Medical Association (AMA) and the American Hospital Association (AHA) each appoint 7 members.
About 5,400 hospitals are accredited by the Joint Commission, about two-thirds of which are in metropolitan areas. Of the 5,388 currently accredited, 36 percent are facilities of fewer than 100 beds, 55 percent 100 to 499 beds, and 9 percent 500 or more beds (Joint Commission, personal communication, 1989). Another 1,600 hospitals are certified by state inspectors to meet the federal Conditions of Participation. Most certified hospitals are small and located in nonmetropolitan areas; they usually do not wish to pay the expense of accreditation and often do not feel the need for the stamp of approval that accreditation implies because they are the only hospitals in their areas.
Although one is governmental and the other private, both the Health Care Financing Administration (HCFA) (as the administrative branch within DHHS responsible for the Medicare program) and the Joint Commission are regulatory in their approach. Each attempts to assure quality of care by influencing individual and institutional behavior. As in any regulatory system, quality assurance in health delivery organizations has three components (IOM, 1986). First, standards have to be set that relate to quality of care. Second, the extent of compliance of hospitals with the standards must be monitored. Third, procedures for enforcing compliance are necessary.
The current federal standards for hospitals participating in Medicare are presented in the Code of Federal Regulations as 24 “Conditions of Participation,” containing 75 specific standards (Table 5.1). Another regulation automatically permits hospitals that meet the Medicare Conditions of Participation to participate in Medicaid. The Health Standards and Quality Bureau (HSQB) of HCFA is responsible for administering and enforcing the Conditions of Participation. In addition to overseeing the Medicare accredited and certified hospitals, HSQB enforces separate sets of Conditions of Participation for over 25,000 other Medicare providers. The actual compliance of hospitals with the Conditions of Participation is monitored for the federal government by each state through periodic on-site surveys by personnel of the state agency that licenses hospitals and other health facilities (or, in a few cases, by an equivalent agency).
Responsibility for revising the Conditions of Participation lies with HCFA”s Bureau of Policy Development, a unit separate from the HSQB. The conditions were first drafted in 1966, by the Bureau of Health Insurance of the Social Security Administration”s Medicare Bureau with technical assistance from the Public Health Service, to ensure that hospitals have a minimum capacity to deliver quality care. The conditions were criticized from the beginning for only looking at the capacity of a hospital to provide adequate quality of care rather than monitoring the hospital”s actual performance or effect on patient well-being. After several unsuccessful efforts to update the conditions and associated standards in the late 1970s and early 1980s, a new set of regulations was promulgated in 1986, which includes a new quality assurance condition that mandates an extensive program for evaluating patient care services.
In 1966, at the time the Conditions of Participation were first drafted, Donabedian (1966) identified three aspects of patient care that could be measured in assessing the quality of care: structure, process, and outcome. Theoretically, structure, process, and outcome are related, and, ideally, a good structure for patient care (e.g., safe and sanitary building, necessary equipment, qualified personnel, and properly organized staff) increases the likelihood of a good process of patient care (e.g., the right diagnosis and best treatment available), and a good process increases the likelihood of a good outcome (e.g., the highest health status possible) (Donabedian, 1988).1
Generally, the conditions in effect from 1966 until 1986 emphasized structural (rather than process or outcome) measures of organizational and clinical capacity, such as staff qualifications, written policies and procedures, and committee structure. These were usually specified at the standard level. The process aspects of quality-of-care standards were usually suggested as explanatory factors that could be used to evaluate compliance with the standard.2
The revised conditions were put into final form in 1986 (51 CFR 22010); they were based in part on conditions proposed in 1983 (48 CFR 299) and 1980 and reflected input from the public through an extensive rulemaking process. In line with the Reagan administration”s emphasis on deregulation, the resulting regulations carried further the process of eliminating prescriptive requirements specifying credentials or committees, departments, and other organizational arrangements; to increase administrative flexibility, the 1986 revisions reflected more general statements of desired performance or outcome. In contrast, some activities were elevated to the condition level to give them more emphasis in the certification process; these included infection control and surgical and anesthesia services. In addition, quality assurance was made a separate condition.
The new Conditions of Participation took effect September 15, 1986. They were accompanied by interpretive guidelines and detailed survey procedures developed by HCFA to increase consistency of interpretation and application by the state agency surveyors (HCFA, 1986).
Joint Commission standards are contained in its Accreditation Manual for Hospitals, parts of which are revised each year through an elaborate process of professional consensus. With the advent of the Conditions of Participation in 1966, which were based on Joint Commission standards of the time, the Joint Commission decided to develop “optimum” standards. An explicit quality-of-care standard first adopted in 1979 has undergone continuous evolution.
Shift from Capacity Standards to Performance Standards
In recent years, HCFA and the Joint Commission have tried to revise their standards in ways that would impel hospitals to examine and to improve the quality of their organizational and clinical performance. For example, both organizations have adopted quality assurance standards that call for hospitals to set up structures and processes for monitoring patient care, identifying and resolving problems, and evaluating the impact of quality assurance activities (GAO, 1988). By and large, these capacity-oriented standards are based on professional consensus, although some are based on research. Under these standards, the medical staff is required to develop or adopt indicators of quality of care, gather information on the indicators, select criteria for deciding when an indicator is signaling a possible problem, and act on those signals. The Joint Commission calls these quality assurance activities “outcome-oriented,” although the main emphasis of the new standards is to make hospitals adopt processes for monitoring indicators of the quality of their performance.
In early 1988, the Joint Commission again eased implementation of the quality assurance standards. It no longer gave contingencies if hospitals were using only “generic” rather than department-specific indicators in monitoring and evaluating the quality and appropriateness of care in the various departments and services. The Joint Commission takes the position that health care organizations do not have available a full set of validated indicators for each area of clinical practice because such do not exist in the clinical literature (Joint Commission, 1988a).
The problems that many hospitals experienced in complying with the Joint Commission standards for outcome-oriented monitoring and evaluating quality of care have been part of the impetus for the Joint Commission”s current and ongoing effort, called the Agenda for Change, to develop indicators of organizational and clinical performance for the hospitals to use (Joint Commission, 1988b, 1988c, 1988d).
Development of the Quality Assurance Condition of Participation
The quality assurance condition implemented in late 1986 is similar in approach although less elaborate than the Joint Commission”s quality assurance standards. The task force of HCFA officials that developed the revised conditions in 1981 and 1982 intentionally sought consistency with the Joint Commission standards (HCFA Task Force, 1982).
The new quality assurance condition as finally promulgated calls for a formal, ongoing, hospital-wide program that evaluates all patient care services. Explicit references to nosocomial infections, medicine therapy, and tissue removal were dropped. The interpretive guidelines state that criteria generated by the medical and professional/technical staffs should guide the information gathered by the hospital to monitor and evaluate the provision of patient care and that information gathered should reflect hospital practice patterns, staff performance, and patient outcomes (Table 5.2).3
The term outcome does not appear in the language of the conditions or standards, however, because the majority of the task force did not think that outcome measures could be used in the survey process. The task force report pointed out that although outcome measures were desirable, in part because they promised maximum flexibility to hospitals, they were difficult to assess without undertaking longitudinal studies beyond the given episode of care, which would be too cumbersome for hospitals and surveyors and would be difficult to use in enforcement.
The 1986 revisions of the Conditions of Participation, including the new quality assurance condition, were largely based on work done in the late 1970s and very early 1980s. They resemble the evolution of the Joint Commission standards in the same time period, when the Joint Commission adopted a quality assurance standard and began to revise the other standards to make them more flexible and less prescriptive. However, the Joint Commission”s standards have undergone substantial evolution since the early 1980s; the latter”s quality assurance standard in particular has undergone a great deal of elaboration in the process of trying to help hospitals understand how to comply with its intent (Roberts, 1988).
The HSQB Office of Survey and Certification administers the inspection and enforcement process for hospitals that are not accredited by the Joint Commission. The process relies on inspectors from state health facility licensure agencies to determine and certify compliance with the Conditions of Participation through periodic on-site visits. In the past, certified hospitals have been surveyed about every 24 months, although HCFA is now requiring the states to shorten the cycle to about 18 months.
The federal regulations governing the survey process and HCFA”s state operations manual are very general regarding survey agency staffing levels and qualifications. As a result, the size and composition of survey teams vary considerably. The person-days spent in on-site inspections and other survey activities also vary. State inspectors undergo a week of training at HCFA and are provided with survey forms on which they mark “met” or “not met” for each condition, for second-level “standards” associated with each condition, and for third-level “elements” associated with each standard. HCFA also provides “interpretive guidelines” for assessing compliance. HCFA does not, however, furnish criteria for deciding which and how many elements have to be out of compliance for a standard to be marked not met or which combinations of unmet standards call for a determination that a hospital is out of compliance with a condition. This again probably leads to significant variations from inspector to inspector as has been found in studies of nursing home regulation (IOM, 1986; GAO, 1988).
Accredited hospitals are surveyed every three years. The Joint Commission has standardized the size and composition of its survey teams, depending on the type of hospital (e.g., general acute versus psychiatric, substance abuse, or rehabilitation). It has developed several sets of formal criteria and decision rules for rating compliance with each standard and associated “required characteristics” on a scale from 1 to 5 and for deciding whether the resulting scores justify accreditation. Use of these criteria and decision rules no doubt increases consistency and reliability, but their validity is not known (OTA, 1988).
Typically, 10 to 15 (0.6 to 0.8 percent) of the 1,800 hospitals surveyed each year by the Joint Commission either lose their accreditation or close voluntarily. The trend over the past few years shows an increase in this percentage. Hospitals that lose accreditation can and many do apply for certification from HCFA in order to stay in the Medicare program; however, the number of hospitals that lose accreditation and subsequently are certified is not currently available from HCFA”s survey and certification data system. There are also cases in which hospitals are decertified by HCFA but retain Joint Commission accreditation. Generally, 1 to 2 percent of the approximately 800 hospitals inspected for HCFA each year by the state survey agencies are decertified involuntarily <9 in fiscal year (FY) 1987, 20 in FY 1986, and 8 in FY 1985> and most are recertified within a short time. Past comparisons of state surveyor and Joint Commission surveyor findings in the same facilities, however, have found low levels of agreement on specific deficiencies (DHHS, 1988).
Most enforcement occurs during the administrative process, in which hospitals are notified of deficiencies (by HCFA) or contingencies (by the Joint Commission) and are given deadlines for correcting them. In response, the hospitals develop plans of correction that are approved by the state inspection agency or the Joint Commission; follow-up visits are made or written documentation is submitted to show compliance, and, in 98 or 99 percent of the cases, certification or accreditation continues. The Joint Commission reports that 4 to 6 percent (about 80) of the hospitals surveyed each year have problems that put them into a tentative nonaccreditation category; most of them make corrections in time to avoid losing accreditation. Similarly, most of the certified hospitals put in the 23-day, “fast-track” termination category—for problems that pose a serious threat to the health and safety of patients—avoid decertification by making immediate changes. A breakout by year (1986–1989) of the accreditation status granted by the Joint Commission to hospitals is shown in Table 5.3.
Numbers of Hospitals with Specified Accreditation Status by the Joint Commission: Four Recent Years.
The Joint Commission has recently developed formal decision rules for determining whether the levels and pattern of compliance with specific standards and required characteristics are adequate and merit accreditation. The rules are also used to make contingency decisions, including if and when on-site follow-up visits or written progress reports are necessary.
In HCFA”s state certification process, a hospital cannot be certified if it fails to meet any Condition of Participation, but decisions on compliance with conditions and standards are left to the judgment of the surveyors, as are decisions concerning the adequacy of plans of correction. If inspectors decide to initiate decertification procedures, hospitals may and usually do remedy the deficiencies in time to avoid actual decertification. Facilities also have extensive legal due process protections that serve as a deterrent to enforcement attempts, as do the difficulties encountered by the surveyors in documenting quality problems (Vladeck, 1988).
Strictly speaking, it is impossible to know, in the absence of research, if this practice of citing numerous deficiencies and contingencies accompanied by little formal enforcement by the Joint Commission or HCFA means that the system is working or that enforcement measures are very weak. Various features of the inspection and enforcement processes used by HCFA and the Joint Commission permit and perhaps encourage under-enforcement.4 The surveyors and their supervisors are health professionals who generally prefer to be consultants to troubled facilities rather than enforcers. The administrative process allows numerous chances for facilities, even those with serious patient-care problems, to come into compliance before they lose certification or accreditation. The Joint Commission is a private organization governed by the health professions it is regulating. HCFA and the state inspection agencies, on the other hand, are public agencies subject to due process rules and vulnerable to political pressures. The inspection agencies have only one sanction, that is, expulsion, which is too drastic to use credibly in situations short of extreme negligence or clearly wrongful death.
Federal responsibility for applying health and safety regulations in hospitals participating in Medicare is delegated, on the one hand, to the Joint Commission, and, on the other hand, to the state survey agencies. Since 1972, HCFA has been required to have the state agencies conduct validation surveys of a random sample of accredited hospitals each year to ensure that the Joint Commission”s surveying of accredited hospitals is equivalent to state agency surveying of unaccredited hospitals. As of late 1989 HCFA was considering a revision of its sampling methodology to improve the effectiveness of its validation efforts (HCFA, personal communication, 1989). HCFA is also authorized to have state inspectors investigate allegations of substantial deficiencies in accredited hospitals. HCFA concludes in its annual reports that the two systems are equivalent, because the percentage of Joint Commission-accredited hospitals found out of compliance with one or more Conditions of Participation (including about 400 a year inspected on the basis of complaints) has been roughly equal to the percentage of unaccredited hospitals found out of compliance (DHHS, 1988).
HCFA also has about 100 federal inspectors based in the DHHS regional offices to conduct validation surveys in state-inspected facilities, but they are primarily devoted to nursing homes and facilities for the mentally retarded. They do not perform enough surveys of hospitals to make any statistical inferences about a state inspection agency”s performance.
HSQB”s Office of Survey and Certification enforces separate Conditions of Participation for over 25,000 Medicare provider organizations in addition to the 1,600 certified and 5,400 accredited hospitals. These include 10,000 skilled nursing homes, 5,700 home health agencies, and 4,775 laboratories. Because hospitals are not perceived to have significant problems, compared with nursing homes and home health agencies, and because there is no deemed status for other types of health providers, this HSQB office devotes most of its resources to these other types of facilities. Also, the funding of Medicare certification activities was cut drastically in the early 1980s and the number of federal validation surveyors fell to 60; at the same time, concern about nursing homes and intermediate care facilities for the mentally retarded became acute and regulation was extended to home health agencies. Funds and staff have been increased recently.
Although the Office of Survey and Certification and the Office of Medical Review, which administers the Utilization and Quality Control Peer Review Organization (PRO) program, are both in HSQB and deal with the same Medicare hospitals, they do not interact in terms of information sharing or coordinated action. At the state level, numerous obstacles exist (e.g., legal and administrative) to deter information sharing about a facility or practitioner between a Medicare PRO and the state survey agency.
The study committee concluded that the Medicare Conditions of Participation and procedures for enforcing them should become a more significant component of and be more consistent with the overall federal quality assurance effort. This position was taken after weighing other options and their respective implications, many of which are stated in Volume II, Chapter 7.
The federal-state and Joint Commission efforts to develop and apply quality assurance standards are hampered in several ways. First, because outcome measures such as functional level are affected by many factors beyond what happens in hospitals, adverse or even improved outcomes are frequently only indicators of possible quality problems or opportunities; as indicators, they can only trigger further investigation to determine if some aspect of hospital care was involved (Roberts, 1988).5 Medicare and the Joint Commission staff responsible for setting the standards have tried, therefore, to mandate quality assurance processes in which hospitals use indicators of quality—outcome-oriented if possible, but usually process and even structural in nature—to examine quality of care. However, few clinical indicators have been adequately validated through research. Even fewer indicators of the quality of organizational performance exist (Kaluzny and Barnsley, 1988; Donabedian, 1989). Nevertheless, to the extent knowledge exists about how to improve quality or make quality assurance more effective, it should be reflected in the Medicare and the Joint Commission standards and survey processes.
The second barrier to quality assurance through certification and accreditation is the limited surveillance capacity inherent in any system of periodic inspections. A two-day visit every year or two limits the ability of even the best surveyors to see if the process of care conforms to standards of best practice in an adequate sample of cases, let alone see what the outcomes were. This distance problem is another reason why those who set the standards have tried externally to impose quality assurance standards that make the hospital itself conduct such surveillance continuously after the inspectors leave (Vladeck, 1988). The Office of Survey and Certification focuses on the facility and not the individual physician. The quality-of-care screens used by the PROs provide limited information on the actual role of a hospital (rather than a physician) in producing adverse indicators. Sharing of information between the two would facilitate focused review by each; this enhanced information flow could alleviate some of the problems occurring from periodic and thus limited surveillance.
A third impediment to the use of regulatory, or self-regulatory, standards to assure quality is the ambivalent attitude of Medicare officials, the state agencies that actually survey the facilities, and the Joint Commission leaders toward the use of sanctions. The reason for the Joint Commission is professional self-improvement. Federal and state officials are primarily motivated by the desire to make Medicare benefits widely available, and they are also subject to political pressure to keep facilities open, if at all possible. The only formal sanction is loss of formal certification or accreditation, a drastic step that officials are reluctant to take except in extreme cases; some states use less extreme enforcement measures that vary in impact. The due process protections of the legal system also discourage enforcement attempts, as do the difficulties of documenting quality problems more subtle than gross negligence or death. Thus, for a variety of reasons, officials are very reluctant to take formal enforcement actions, especially to the extent of terminating a facility, preferring to work with substandard or marginal facilities over time and bring them into compliance. This approach works well if the hospitals involved have the will and capacity to improve if shown how to do it, but it is ill-equipped to deal with places that cannot or will not improve.
Fourth, whereas the federal government has delegated much of the standard-setting and enforcement to private accreditation bodies on the one hand, it has given away much discretion to the states on the other. The states have always varied greatly in their interpretation of federal standards, and little has been done to increase consistency. HCFA requirements for state survey programs are very loose. It was recognized from the beginning that who does the surveying is critical, “since this greatly influences what the emphasis will be, regardless of what the standard setters think the emphasis should be” (Cashman and Myers, 1967, p. 1112), but little has been done to standardize state survey capacity or process. The development of interpretive guidelines and survey procedures for the new Conditions of Participation was a step in the right direction.
A number of steps should be taken by HCFA to strengthen the Conditions of Participation process, working with both the Joint Commission on deemed status and the state survey and certification agencies for those hospitals not accredited. This initiative should include updating the conditions and their related standards and elements within the next two years and continually thereafter (no more infrequently than every three years). The Department should continue to support the concept of deemed status for hospitals. In addition, the Department should encourage the Joint Commission in its efforts to develop a state-of-the-art quality assurance program and in its program to disclose information to the Department or its agency about conditionally accredited and nonaccredited hospitals in a timely fashion. A reasonable amount of contact with Joint Commission activities will be necessary on behalf of the Department to ensure that the Joint Commission”s accreditation program remains consistent with the intentions of the Medicare Program to Assure Quality (MPAQ) as recommended by the IOM study committee in Chapter 12. The Secretary should improve the coordination of federal quality assurance efforts by developing criteria and procedures for referring cases involving serious quality problems from the PROs (or their restructured entities described in Chapter 12 under the proposed MPAQ) to the Office of Survey and Certification (and vice versa).
In addition, the committee identified the following steps to be taken by HCFA to strengthen the state survey and certification system: (1) specify the size and composition of state survey teams; (2) use survey procedures and instruments that focus more on patient care and outcomes and less on medical records; (3) develop explicit (national) decision rules for determining compliance and taking enforcement actions; (4) adopt intermediate sanctions (e.g., fines, suspensions from Medicare admissions, and focused restrictions) that better reflect the problem being addressed; and (5) use more federal inspectors to evaluate state agency performance (through validation surveys) and to inspect state hospital facilities.