What organization mandates QA programs

The original legislative charge for the studies of the quality of B&C facilities and home care services called for an examination of whether existing quality, health, and safety requirements and their enforcement are (1) appropriate, (2) effective, and (3) adequate. Put another way, in terms of assuring and improving quality, the questions could be posed as follows: (1) Are the right things being done (appropriateness)? (2) Are those things being done well (effectiveness)? and (3) Are enough of those things being done (adequacy)?

This committee could not and did not seek to answer those questions definitively. Rather, it has identified several problem areas in regard to the overall appropriateness, effectiveness, and adequacy of existing quality assurance and improvement strategies as they might be directed at services rendered in home and community-based settings. In identifying these issues, the committee noted, with concern, how little information is presently available that would permit a quantitative examination of these topics.

To answer the question of whether the “right” strategies for measuring and managing the quality of resident or patient services are in place, one ought first to have a clear view of what quality is. In the broad area of home and community-based care, this is often a more difficult issue to come to terms with than it might be in the general area of inpatient and outpatient medical care rendered in traditional settings. For one thing, in this broader arena, the services stretch beyond well-known medical, nursing, or rehabilitation care to a variety of other personal assistance and social services that have not traditionally been the focus of organized quality assurance programs. Thus, what exactly constitutes a set of appropriate quality assurance or improvement procedures for this growing area of care cannot be answered definitively by this committee.

Moreover, as is true in health care as a whole, consumers, caregivers, providers, and purchasers all have differing views of what constitutes quality. One consumer may consider a service to be of high quality; another may regard it as poor. Differences between consumers or residents (on the one hand) and providers or purchasers (on the other) may be even greater, because of differences in preferences, in the kind of information brought to bear on the question, or in the criteria used to evaluate quality. Some programs have begun to develop frameworks and practical tools to help reconcile these differences, but much work remains to be done in this arena (New England SERVE, 1989).

Apart from how judgments about quality may differ depending on who is doing the evaluation, there is the issue of differences between intended and achieved effects. Some strategies to ensure quality may have the opposite effect in practice. For example, Florida requires that any resident of an adult congregate living facility who remains bedfast for longer than 14 days has to move to a facility that can provide a higher—and presumably more appropriate—level of care. For many residents who are then forced out their “homes,” however, this represents a significant decrease in quality. An approach that allowed more flexibility so that consumers could remain in the least restrictive setting could, in fact, prevent some individuals from receiving care in an institution.

Some strategies to protect the health and safety of residents may, even with all good intent, go too far and deny some individuals certain rights established under the Americans with Disabilities Act and other laws. As a case in point, a recent study sponsored by the American Association of Retired Persons found that some residents of group residences for frail and disabled older persons have had their “housing choices and personal autonomy limited by overt acts of discrimination or by rules and regulations regarding health, safety, and land use” (Edelstein, 1995, p. iv). Thus, what on paper may appear appropriate as a quality assurance mechanism may, in the event of its implementation or enforcement, have entirely unintended consequences.

How actually to implement quality assurance and improvement strategies can be a complicated proposition, particularly given the remarkable diversity of the population receiving home and community-based care. Substantive evaluation never relies on only one type of measure or approach. A variety of flexible strategies needs to be developed to deal with a variety of situations; one predetermined strategy may well not be appropriate for all circumstances. For instance, an approach that relies heavily on consumer input and feedback to monitor the quality of care may not be suitable when consumers are cognitively impaired, even if surrogates or proxies for those individuals are available. Similarly, functional assessment is different for children, adults, and the elderly (NRC/IOM, 1994), and this variation must be considered when developing appropriate outcomes measures to be used in quality improvement programs.

Finally, assessing and improving care involve costs. Decisions and trade-offs have and will continue to be made about how much we as a society are willing to invest to achieve and sustain high-quality services, especially in these newer settings for services. We will need to look particularly at the trade-off between the quantity of service that an individual may receive and the formal credentials demanded of those who provide the care. For example, to the extent that licensed nursing personnel are used to provide care (often considered a structural characteristic of high-quality care), the services will almost certainly be more expensive and the individual will have less flexible coverage at irregular hours (as is feasible with some unlicensed workers, including the self-employed). Another trade-off concerns the cost of quality assurance versus the cost of care itself. A perennial debate, worth revisiting particularly in the home care context, is how best to invest resources in quality assurance activities in an arena widely believed to have limited resources for actual service provision. 1

The legislation authorizing these studies directed the IOM to determine whether existing quality assurance and improvement strategies are effective in promoting good personal care. Again, a distinction between external (or regulatory) and internal quality management programs is relevant, and the committee found both encouraging and discouraging indications about this matter.

For example, a recent study of B&C facilities by the Research Triangle Institute found that in states rated as having extensive regulation, several quality indicators were higher than in states rated as being less regulated (Hawes et al., 1995). These indicators include lower use of psychotropic drugs, lower use of medications contraindicated for the elderly, more provider training, and greater availability of social aids and supportive devices thought to improve overall quality. Recent studies about the effects of nursing home regulations enacted in OBRA 87 (based in part on the recommendations of the IOM study [1986] on reforming nursing home care) also suggest that these steps have improved the situation for residents of nursing facilities in terms of lower use of physical or chemical restraints, for example, and better attention to residents' rights (Phillips et al., 1993).

Conversely, little evidence exists to show that using the common structural measures of professional credentials and minimum training has an impact on quality outcome measures in home and community-based care (Perrin et al., 1993). 2 Part of the problem here is methodologic: Structural measures are proxies for actual assessments of process and outcome, and they are notoriously difficult to link directly to process and outcome variables with reliable, valid empirical data. It is clear, however, that requiring these standards to be met does raise costs and reduce the availability of services (Kane, 1995). Additionally, several studies have shown that consumers place greater value on the characteristics, rather than credentials, of their care providers; that is, they want people who are honest, reliable, and caring and who do a good job, not simply those who have a professional degree or have completed a training course (Eustis et al., 1993; Kane et al., 1994).

In general, however, the traditional focus of much externally imposed regulation has been primarily on identifying and dealing with “outliers,” the small percentage of providers who give extremely bad service. Experts can argue about the extent to which such programs are effective in removing such practitioners or providers from practice. For example, considerable experience with the Medicare program (through both the Professional Standards Review Organization program and the Peer Review Organization [PRO] program) suggests an uneven pattern of success with respect to hospital care (IOM, 1990). There is little if any empirical evidence on the question for outpatient medical care or (especially) for home and community-based care.

Problems have also been noted in the effectiveness of existing complaint resolution mechanisms. A recent study by the IOM (1994) noted barriers to the effectiveness of LTC ombudsmen working in B&C facilities, including limited access: It found that in most states ombudsmen are not a major presence in such facilities. 3 As noted earlier, ombudsan involvement with home care consumers is extremely rare; given the likelihood of federal cuts to the ombudsman program, it is not expected to expand significantly. Sabatino (1992) found a low utilization of Medicare complaint hotlines and questioned their effectiveness as a complaint resolution strategy.

The effectiveness of provider registries has also been questioned (IOM, in press). Although required by law, many are not updated regularly, include information only on cases that are resolved, and may not be utilized by employers who fear litigation from former employees. Most importantly, these registries cannot prevent abuse from happening in the first place.

A more significant issue, however, is that typical external quality assurance efforts are not established or conducted with the aim of steadily improving the average performance of providers over time—that is, of “shifting the curve upward.” In this regard, traditional approaches may or may not be effective in weeding out poor performance and ensuring that practitioners or others meet some minimal standards, but they are rarely effective in promoting sustained efforts at continual improvement within organizations or agencies. Most programs are “not in a position to identify exemplary providers or to offer assistance in reaching higher levels of quality of care” (IOM, 1990, p. 48). This is one reason that, in recent years, quality-of-care experts, organizations such as the JCAHO, and government agencies such as HCFA have all advocated and facilitated the adoption and implementation of rigorous quality improvement programs by provider organizations and facilities.

Such programs cannot be regarded a priori as the answer to effective quality management, however. Apart from the usual barriers to effective quality improvement, internal programs may be of limited effectiveness because “conflict over authority, lack of commitment or expertise, concern about financial repercussions for individuals or of financial stress in the organization may result in inaction despite well-known and well-documented problems” (IOM, 1990, p. 48). However, health care providers in recent years have begun to develop far more sophisticated quality improvement and quality management programs than were known even a decade ago, and some are beginning to demonstrate real improvements in quality of care (Lohr, 1995). For example, nursing staff interventions in a continuous quality improvement context at an Intermountain Health Care hospital dramatically lowered the rate of decubitus ulcers among inpatients (Susan Horn, Ph.D., Senior Scientist, Institute for Clinical Outcomes Research, personal communication, July 10, 1995).

Consumer satisfaction surveys are a well-known adjunct to quality improvement efforts by provider organizations, but their record with respect to effectiveness is not conclusive. In particular, the validity and utility of these surveys have been questioned for use with such a vulnerable and service-dependent population as consumers of LTC, who may be hesitant to provide potentially negative feedback about services on which they depend (Davies and Ware, 1988). Promising strategies to deal with this and other problems include assuring anonymity, rewording questions, and using in-person and telephone interviews rather than written surveys (Capitman et al., 1994a). Nonetheless, although consumer input is critically necessary, it is probably insufficient to judge the technical aspects of care.

As noted earlier, whether quality assurance and improvement programs are adequate should be judged in terms of whether enough of them are being conducted, recognizing that prior questions of appropriateness and effectiveness also need to be answered. Moreover, the issue of adequacy has to be evaluated in terms of the levels of quality problems (i.e., frequency, severity) that must be tackled. Thus, this question will be difficult to answer, because knowledge of the extent or seriousness of quality problems is extremely limited.

A fundamental problem is that many home and community-based services are provided in isolated settings such as individuals' homes and apartments. Public and peer oversight is extremely limited or nonexistent for these environments and services, and virtually no systematic data have been collected about quality of care apart from those amassed through research projects. Even federal regulatory efforts that have had formal legislative mandates to collect and use quality-related information in the home health care arena, such as the PRO program for Medicare, have not developed as clear a picture of the types, frequency, and seriousness of quality problems in these settings as would be either desirable or necessary to comment on the adequacy of quality assurance efforts. As a general proposition, the adequacy of quality-of-care programs in this area can probably be called into serious question.

What seems clear to this committee is that achieving good quality of home and community-based services will require a variety of both external and internal programs. For example, given the infrequency of licensure and accreditation surveys, these programs on their own have little capacity to oversee how well care fits the needs of consumers who age in place or who have a change of status. Conversely, reliance solely on putative quality improvement efforts undertaken by provider groups or agencies with little formal training in quality measurement or little history of successful implementation of such programs would be foolhardy. Taken together, however, well-founded regulatory requirements, sensible outside monitoring of performance, and solid internal programs that capitalize on such steps as periodic reassessment of the consumer's individualized care plans and appropriate use of data can increase the likelyhood that consumers and residents receive the highest quality services possible. The challenge will be to develop means by which the appropriateness, effectiveness, and adequacy of these efforts can be defined and evaluated.