Simple Fixes for the OBRA Regulatory Process

by Steven Levenson, MD, CMD

Part Four of a Series on the Survey Process

Previous columns in this series have demonstrated how and why the OBRA regulations and survey process have not succeeded as well as expected in improving nursing facility care and practices. This month's column provides suggestions for ameliorating the situation.

Time for a Different Tone

Nursing home care and health care in general are not unique human enterprises. They depend on human performance and therefore can be improved by respecting relevant principles.

Yes, we should have regulations--but, as noted previously (see "Why OBRA Regulations & Surveys Can't Fix LTC," in the October 2001 Caring, p. 26), we must bear in mind that regulations were not developed as a primary reference for providing effective geriatric care, and should not be used for this purpose. Yet, the regulatory process provides major consequences--i.e., sanctions--for poor performance; therefore, it should incorporate basic principles of performance improvement, such as reinforcing--not inhibiting--appropriate care processes and inhibiting--not approving or overlooking--improper practices. The fact that the current system does not do this adequately contributes substantially to inconsistent results.

Certainly, we have seen examples of inadequate care and inappropriate performance in nursing facilities. But there are many different causes for those performance problems--just as different individuals have many possible reasons for symptoms such as anxiety, abdominal pain, or agitated behavior.

The current OBRA regulatory and survey system is based on a false assumption that providers, practitioners, the public, and state agencies share a common understanding of accepted processes for providing quality care, and that these do not need to be discussed, studied, taught, or detailed. But this is not the case. Much of the long-term care work force and many practitioners lack the skills and judgment of trained geriatricians. And good geriatric practice cannot be learned from a book or a set of regulations (State Operations Manual).

Correct Imbalances between Results & Processes

The "outcome-oriented" OBRA system was a reaction to the "paper-compliance" system that preceded it. In response to the old system--in which surveys could be performed merely by looking at records--the government adopted a system that focuses primarily on detecting, classifying, and responding to "negative outcomes." Unfortunately, this approach is great at chasing symptoms but poor at identifying or preventing causes.

As discussed throughout this series, outcomes are important, but they cannot be judged appropriately without understanding related processes. The OBRA regulations and survey system must concentrate more on processes and reduce excessive reliance on outcomes measures. This may contradict current conventional wisdom, but the simple fact is that we have gone to the opposite extreme in trying to correct the problems of earlier survey approaches. We must not erroneously equate care process with "paper compliance."

Nursing home practices and performance (clinical and nonclinical) ultimately must reflect the care process (problem recognition, cause identification, etc.)--not regulatory Tag numbers. Individual care elements such as behavior management and medication utilization are components of this larger picture. In most instances, care problems are symptoms of bigger issues, with causes that go beyond the apparent problems--that is, problems with weight loss are not just about nutritional practices, problems with resident rights are not just about lack of respect for rights, and so on.

For example, physician and nursing assessment and communication skills influence medication utilization, which affects the occurrence of adverse drug reactions, which in turn may affect weight loss and dehydration, behavior, unplanned hospitalizations, skin breakdown, and falls.

Therefore, regulations should concentrate more on assessing and reinforcing good care and management processes and less on judging practices (how practitioners managed a situation or addressed a risk). Whereas specific interventions (or lack thereof) may be optional and arguable, the care process should be universal. Correct practices are important--but outcomes improvement requires systematic processes that reflect sound principles.

Streamline, Clarify, & Consolidate Surveyor Guidance

Despite numerous instructions and related guidelines and procedures, facilities, practitioners, and state agencies still vary widely in interpreting expectations under the OBRA regulations, and--even in similar situations--surveyors do not consistently interpret compliance.

According to the recent Institute of Medicine report, Improving the Quality of Long-Term Care (search.nap.edu/books/0309064988/html/), "States vary substantially in their survey and enforcement findings, and no evidence suggests that this variation is a function of corresponding variation in the quality of care provided in the states" (p. 151). One of the report's major recommendations is to improve the survey process "by ensuring greater uniformity in state surveyor interpretation and application of survey regulations" (p. 162).

It is not true that providing relevant details ties surveyors' hands or interferes with their judgment. In fact, it is a basic management principle that vague instructions yield inconsistent results. Current surveyor guidance contains too much irrelevant detail about practices to be useful. More relevant details can help produce more appropriate conclusions arising from evidence-based judgments, thereby reducing conflicts and confusion among facility staff and surveyors.

Surveyors need guidance in clear, consistent, valid methods in order to collect and analyze information. But crucial guidance in these areas (contained in the surveyor "probes" and "Investigative Protocols") is often vague, contradictory, and disorganized, leading to widely divergent approaches. The guidance should be revised and made more consistent.

Surveyors and facility staff need general care-process expectations for all conditions and situations (including quality of life and quality of care), and more rigorous guidance about how facility staff may justify their practices. Organized process indicators based on care-process steps tell practitioners what steps to follow and surveyors how to identify whether those steps were followed.

Nursing facility staffs are responsible for following the steps and showing surveyors--through care results, documentation, etc.---that the steps were followed. Surveyors are responsible for reviewing the evidence they receive in a fair, objective manner, using standardized methods.

Change Approach to Evaluating Facility Practices

Much of the survey process revolves around determining whether a facility has a "faulty" or "deficient" practice. According to the SOM, a faulty practice is one that does not meet regulatory requirements. However, the SOM also states that a "faulty/deficient practice" does not necessarily constitute a "deficiency" (i.e., a failure by the facility to comply with a condition of participation). Not surprisingly, that kind of circular guidance is confusing and often simply means, "you decide." But that approach does not work. There should be no secret criteria for facilities, surveyors, or practitioners. Everyone needs clearer methods and criteria for identifying a "faulty/deficient practice."

Obviously, 100% procedural compliance is not achievable, and most processes can be adequate (that is, the end result of the process is satisfactory) despite some imperfections. But processes that are generally consistent despite occasional imperfections are very different from haphazard ones. Facilities with occasional process problems, but with staff who usually act appropriately--for example, draw proper conclusions, institute pertinent treatments, and follow most steps consistently--are very different from facilities in which staff and management do not act appropriately, do not know why their actions are inappropriate, and do not seek, find, or address their process problems.

Thus, the fact that a minor procedural error (which should not be penalized) is made on the one hand, and a negative outcome is seen on the other, does not automatically mean that the two are related. Yet, much of the surveyor guidance allows or even encourages surveyors to make such associations, especially when serious negative outcomes occur.

A key criterion for regulatory compliance should be whether facility staff can offer plausible explanations for what they do and why they do it, instead of just demonstrating that they do things. If a generally accepted process exists, then conclusions that a process or practice is incorrect or the cause of an undesired result should be based on some evidence, and address these key questions:

• What did the facility do that it should not have done?
• What steps or tasks did the facility fail to do that it should have done?
• What did the facility do incorrectly, inconsistently, incompletely, or not soon enough?

The preceding is especially relevant when surveyors challenge care practices. Not surprisingly, facility staff often react seriously to surveyor advice about their practices--for example, the facility should use a different tube-feeding schedule or formula, offer laxatives if there is no bowel movement within three days, use specific forms to document care--even when that advice is incorrect or merely opinion.

Every section of the OBRA regulations should include generally accepted process indicators for both clinical (falls, incontinence, behavior management, etc.) and non-clinical (resident rights, quality of life) topics (see box below). These indicators should identify important steps sequentially and anything that must or should be done at each step. The steps should reflect evidence and reliable consensus (for example, in established clinical practice guidelines) to support the expectations. In that way, both surveyors and facility staff will know the expectations for procedural compliance, and interpretation should be more consistent. In addition, facility staff and practitioners should be allowed to justify legitimate variations.

Next month's column will continue to focus on specific changes that can improve the OBRA regulatory process, including the use of more consistent survey methods, strategies for identifying negative outcomes, and appropriate ways of determining "avoidable" results.

Steven Levenson, MD, CMD, is a Multi-Facility Medical Director in Baltimore, MD, and Chair of Caring's Editorial Board.

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