Drawing Conclusions About Compliance

Part Six of a Series on the Survey Process

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

After gathering and analyzing information, surveyors and state agencies are charged with identifying deficiencies and using survey findings to draw conclusions about a facility's compliance with regulatory requirements. But there are problems with the process for determining and characterizing deficiencies. These problems must be addressed so that the survey process can help correct the real issues of nursing home care.

Meaning of Compliance

Care should be given to benefit patients, not for regulatory compliance. Any worthwhile compliance system--regulatory or otherwise--should serve that objective. Survey compliance determinations should accurately reflect facility performance.

As discussed previously in this series, an effective OBRA survey process would identify and help correct seriously problematic care; it would not mistakenly label appropriate care as problematic. Although it has had some positive impact, the current survey process is not truly effective: it finds only some problematic processes and practices, only occasionally leads to the detection and correction of root causes, and not infrequently finds regulatory compliance in facilities that provide some inappropriate care.

In earlier columns, we suggested ways of changing the survey process and surveyor instructions in order to improve the quality and relevance of information collected to determine compliance. This month's column considers how to improve the analysis of this information to draw more meaningful conclusions about compliance. Proposed improvements include changing the criteria for compliance, rethinking the concept of a "deficiency," and revamping the approach to defining the seriousness and scope of problems.

Improving Validity of Deficiency Determinations

Implementing the following suggestions would go a long way toward improving the survey process.

Make deficiency determinations and penalties consistent with performance-improvement principles (see box at right)
Although deficiency determination can never be an exact science, it can certainly be improved. Moreover, if it is to help advance nursing facility care, the survey process should not focus facility staff on avoiding deficiencies, but rather on doing the right thing even when they are not being watched or surveyed. Otherwise, we perpetuate the present situation, in which the staff of many facilities focus primarily on trying to avoid deficiencies instead of on the best possible practices.

Clarify criteria in advance
To understand when we are doing something properly, we must match our performance against explicit criteria. In order to consistently provide proper care, facility staff must know in advance what they are supposed to do, so that the presence of a surveyor isn't necessary to assure appropriate practices. Survey procedures should include organized, explicit methods and criteria for evaluating performance and practice, which aid both facility staff and surveyors. The existing procedures are neither consistent nor explicit.

Make expectations technically correct and achievable
Every element of the OBRA regulations should be reviewed and updated, and all care-related requirements should be reconciled with proper clinical and management principles, and with a proper care-delivery process. All clinical and nonclinical expectations should be covered by clear, orderly process indicators. Surveyor guidance should relate clearly to specific procedural expectations--for instance, what constitutes a timely intervention or an accurate assessment?

Target deficiency determination
Encouraging surveyors to find more and more deficiencies will not result in better nursing facility care, just as care quality won't necessarily improve by giving patients more tests and treatments. Better to influence a few areas that make a substantial difference rather than trying to affect many things that make little or no difference.

Deficiencies can point out correctable or uncorrectable situations. As with patient care, we could identify many uncorrectable situations, but what's the point? And, as with managing patients, even correctable situations may have little impact on the ultimate results. Therefore, deficiency determination should be targeted towards correctable situations that evidence suggests have an appreciable impact.

In fact, relatively few interventions account for a majority of benefits to chronically ill, frail individuals. For example, medications are known to cause many serious problems such as anorexia and delirium that affect function and quality of life. Thus, appropriate medication review is a potentially fertile area for positively affecting resident outcomes.

But guidance for identifying important adverse drug reactions is inadequate and surveyors and state agencies often avoid important medication-related issues. Staff in many facilities tend not to address these issues unless surveyors note them because they pass the survey without having such problems identified.

The truth is, staff in many nursing homes believe that if surveyors don't say they are doing something wrong, then what they are doing must be right. This is how facilities achieve regulatory compliance, despite the fact that staff are giving at least some inappropriate or ineffective care.

Change the focus of deficiency determination
In the current system, a deficiency can be given for any form of noncompliance with regulatory requirements, no matter how minor. But this leads to too much focus on isolated details and not enough on the "big picture"--that is, the significance of an identified error or omission in a broader context.

Labeling a problem as a deficiency, instead of focusing on it as a problematic practice needing improvement, leads to some inaccurate and debatable compliance determinations. This approach also perpetuates the misconception that each situation, condition, or area of care can be managed independently of the others.

But individual parts of care systems, like body organ systems, are interdependent and problems often have multiple causes. The SOM should encourage appropriate analysis of root causes and care processes, relating them to deficiency determinations and enforcement actions.

Take a realistic approach
The survey process cannot realistically expect universally error-free processes or practices, but it is reasonable to expect consistently correct processes most of the time. Current surveyor guidance notes that an error or omission is not automatically a deficiency--for example, it allows a 5% medication pass error rate.

Thus, the SOM should require surveyors to review an entire process or situation before deciding that a deficiency occurred; it should not encourage them to jump to premature conclusions based on isolated findings. The SOM should also clearly identify the few situations in which isolated findings are so serious or inherently dangerous that they represent deficiencies--for example, failing to provide ordered hydration for a day to a potentially viable individual who is moderately or severely volume depleted.

In fact, all areas of the survey process should incorporate thresholds for acceptable performance--for example, a facility is compliant with a provision if it can show that it has performed at least 90% of the pre-established steps associated with managing a care process such as falls or addressing quality-of-life issues. This would give facility staff some incentive to improve their processes, which is their most likely route to improving patient outcomes.

Until the current situation changes, facility staff have too much incentive to address minutiae in order to avoid deficiencies, instead of correcting the root causes of care- and systems-process problems.

Make deficiency statements more explicit
Current deficiency statements often resemble facility medical records, because they contain lots of descriptive details but little useful analysis of that information. The statements may give facts--dates, times, descriptions of alleged noncompliance, who did or did not do what, etc.--and provide quotes of the parts of the regulation that the facility allegedly failed to meet.

But the statements may not appropriately explain the technical reasoning behind the conclusion (e.g., why was this wrong, inadequate, etc.) or indicate what should have been done differently or why doing it differently would likely have led to a different result. Without such details, or with incorrect information or conclusions, facility staff may not be able to fix the situation.

Regrettably, progress in this area is inhibited by legal maneuvering. Government lawyers tell survey agencies not to give detailed instructions about correcting problems. Why? Because if facility staff follow the advice incorrectly or don't correct the problem for other reasons, facility lawyers will blame the advice or argue that the facility should be considered compliant because the staff did what the state agency advised.

The result: the survey process again misses opportunities for promoting performance improvement.

Simplifying the Deficiency-Determination Process

As discussed previously in this series, the OBRA survey process has developed a complex series of steps to determine compliance (see Current Approach to Compliance Determination in the box below). The SOM instructions tell the surveyors to follow certain steps and use certain criteria to identify compliance. It is time for a different approach (see Proposed Modifications).

Currently, the SOM instructs surveyors to first determine whether a deficiency exists before considering whether the problem is worth citing. It permits surveyors to draw conclusions about deficiencies at any point in time, regardless of whether they have collected or considered all relevant evidence.

Moreover, the SOM permits surveyors to sidestep rules of evidence when there is a negative outcome--to look for isolated process problems to prove that the process caused the result. Surveys focus too much on defining deficiencies related to F-Tags and not enough on investigating real problems. This should change. We need a system in which surveyors consider all relevant criteria--including how individual findings relate to a facility's overall performance and to resident outcomes--before concluding that deficiencies exist.

Next month's column will review additional ways to improve compliance determination and thereby provide a better basis for enforcement and plans of correction.

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.

back to top