Improving Compliance Determination

Part Seven of a Series on the Survey Process

by Steven Levenson, MD, CMD & Charles Crecelius, MD, CMD

Last month, we discussed ways to improve the process for determining and characterizing deficiencies. This month's column offers suggestions for transforming the approach to scope and severity determination and more effectively summarizing compliance.

Transforming Scope & Severity Determinations

The underlying rationale for the current approach to scope and severity determination appears to be reasonable: consequences should be related to the seriousness of infractions and the extent of their impact on residents. However, the system doesn't work very well in practice. It focuses too much on punishing infractions and not enough on putting errors in context or identifying their root causes. Thus, it encourages evasion and denial to avoid severe penalties imposed for some inappropriately low thresholds, while failing to identify the seriousness, scope, or underlying causes of broader facility process and system failures.

The current survey approach needs an overhaul.

Clarify "Harm"
The current approach demands that the surveyor determine when the facility has caused harm, but does not present enough useful criteria or methods for doing so. The result is inconsistent and often inaccurate or irrelevant allegations. Unless they are sufficiently sensitive and specific (that is, identifying real--not unwarranted--causes), surveyor findings do not correct performance problems.

As with many terms in the State Operations Manual, "harm" is used in several incompatible ways, resulting in confusing and conflicting interpretations. Sometimes, the word "harm" means a negative patient outcome independent of any cause (e.g., a fall with injury); elsewhere, "harm" means a negative outcome that is due to a facility's faulty care or practices.

When surveyors equate a negative outcome with harm, they may assume that a negative outcome must be someone's fault, and that therefore they must find some process error--however small--to "prove" the point. But this conflicts with the notion that many negative outcomes occur without being someone's fault.

In addition, considering harm as the impetus for a fault-finding mission undercuts the more desirable search for process problems that both cause and potentiate negative outcomes. This misconception influences some of the individuals--including members of Congress--who influence or create regulations.

We can't fix something that has already happened. Therefore, our best potential for improving care is to correct underlying causes and current problems before something bad happens. Although sanctions can punish people for results, they do little to ensure that subsequent results will be better.

Overhaul Immediate Jeopardy
The whole section of the SOM on Immediate Jeopardy (IJ) needs a drastic overhaul. IJ is intended to be a special category with specific, severe implications. It was meant to identify and remedy situations posing a convincing or compelling risk of danger to residents--for example, failing to ensure that residents get the lab tests or interventions needed to maintain fluid and electrolyte balance.

But it has lost that focus, and instead appears to have become a way to punish facilities for serious outcomes regardless of the facility's contribution to those outcomes. The current definitions and guidelines are unclear as to what may constitute IJ, especially when there is only risk or likelihood of IJ. Perhaps more importantly, they do not adequately link an alleged severe outcome with severity of deficient practices.

Appendix Q's introduction notes that IJ is "a crisis situation" in which a resident's heath and safety are at risk. The need for dealing with such threats seems obvious, especially if limited to actual life-threatening situations. Indeed, "the primary goal of...these guidelines is to identify and prevent serious injury, harm, impairment and death."

But IJ is then further qualified in other, seemingly less stringent ways. Terms such as "is likely to cause," "high potential for these outcomes," "occur in the very near future," and "to prevent" become far more subjective and may not describe a crisis situation. Incorrect estimation of likelihood can easily turn a relatively minor deficiency into IJ.

Furthermore, the IJ instructions inconsistently identify deficient practice(s). IJ itself is defined as a situation in which noncompliance with requirements of participation has caused or is likely to cause serious injury, harm, impairment, or death. But it is noted that a federal regulation may not be found for each situation, and that the team must try their best to assign an F-tag. While an argument for this latitude could be made for egregious errors obviously resulting in death or injury, this same principle apparently applies to situations in which both the likelihood and nature of apparent harm may be subject to interpretation.

IJ guidelines also fail to adequately consider underlying facility process problems, deficient care practices, or root-cause analyses. They present the notion that the facility created or allowed certain situations, and then require corrective or preventive measures.

Although immediate action may be needed to address clear instances of present danger, it is hard to alleviate potential harm without identifying and fixing root causes. Correcting IJ citations to satisfy a state agency may not truly remove risk, especially if surveyors do not have the expertise to correctly identify contributing factors.

Thus, the notion of IJ is relevant, but it needs to be clarified and refocused on its primary purpose: to rapidly correct problems that present a clear and present danger.

If IJ is to be used to sanction facilities for something that has happened or might happen, then we need much better criteria to identify IJ. Otherwise, distinctions between other levels of deficiency and IJ are merely capricious.

For example, IJ might apply when there is not only a process deficit, but the likelihood that a process deficit will continue or result in a negative outcome, regardless of whether or not the current situation is corrected promptly--for instance, because the facility doesn't have or can't implement an alternative way to reach or draw a proper conclusion, make a correct intervention, or fix a faulty process.

If a state survey agency alleges that a facility is in IJ for something that has not yet happened, then it should be expected to explain why the current situation or practices must be corrected immediately to avoid subsequent damage--for example, the facility reasonably could or should have known that: failing to consistently help individuals needing substantial eating assistance could lead to dehydration or weight loss; repeatedly failing to review major condition changes with physicians in a timely fashion could lead to potentially preventable complications; or not training direct care staff in abuse prevention and not investigating significant unexplained injuries could result in a continued pattern of abuse.

A pattern of such findings could lead to the conclusion that a) the facility is one in which process problems occur repeatedly; b) the facility lacks consistent processes to prevent and detect such problems; and c) as a result, the facility's processes and practices make future serious adverse events likely to occur.

Summarizing Compliance & Writing Plans of Correction

What good is the deficiency-determination process if it cannot separate poor performers from the rest and bring about definitive improvements?

The overall survey processes should be modified to reflect the principles set forth in this series. All reviews should be tied to meaningful process expectations supported by understandable criteria, and focus on trying to improve processes that affect resident quality of life and other meaningful outcomes. Simply put, regulatory compliance expectations should always relate to the purpose of such compliance.

The survey should also lead to clear conclusions that stimulate root-cause analysis to correct process problems so that subsequent care minimizes avoidable risks and focuses on major items known to improve quality of life in this population.

The idea of a graded approach to compliance makes sense. But its current rendition as an alphabet grid (Levels A through L) doesn't work well. Worse, some facilities can comply by avoiding a Level G or above while providing mediocre care, whereas other facilities can potentially qualify for severe sanctions (Level G or above) for as little as a single procedural error in a single patient on a resurvey. The goal becomes avoiding deficiencies or penalties instead of meeting the actual survey intent. This is an unrealistic and unworkable framework; thus, it's time to discard the alphabet soup, and replace it with a more pertinent and less complex, graded approach to compliance.

Under our proposed approach (see box at bottom), Level 3 and Level 4 facilities are most likely to have system-wide problems that go well beyond individual aspects of care and service. In these facilities, isolated process problems often reflect much broader underlying systems causes--for example, problems with high rates of skin breakdown or excessive unplanned hospitalizations may relate to physician accountability, nursing assessment, nursing assistant performance, and so on. It does not help just to correct the isolated or specific practices or processes. Instead, root causes--such as ineffective physician oversight or inadequate care processes--must be corrected or the facility will simply address certain Tag numbers, but subsequently be cited for different ones.

Surveyors may suspect that a problematic facility has broad, system-wide problems. Our proposed survey approach promotes a less biased and more comprehensive and accurate assessment in such circumstances.

Level 3 and 4 facilities need close attention, frequent follow up, and clear requirements for plans of correction focused on getting competent help for finding and fixing root causes. They may also require the threat or actual imposition of major sanctions for repeated failures to make effective progress. By contrast, Level 1 and 2 facilities need a very different approach, oriented more towards simple plans to improve specific elements of care and correct relatively minor systems or process problems.

The current compliance determination process is too prescriptive for those at Levels 1 and 2 and not adequately detailed for those at Levels 3 and 4. But using this revised approach would give facilities an incentive to focus on fixing serious systems and process issues in order to reduce risks and optimize outcomes. It is important to communicate that process compliance is a major consideration both for events that already happened and for events that could potentially happen.

Next month's column will consider the implications of a revised approach for plans of correction and enforcement activities.

Dr. Levenson is a Multi-Facility Medical Director in Baltimore and Chair of Caring's Editorial Board. Dr. Crecelius is President of the Missouri Association of Long-term Care Physicians and Medical Director of Demar Gardens West in St. Louis, MO.

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