A surveyor's perspective: commentary and guidance on the new guidelines from a former state surveyor.

Once again, the standard of care has been raised for nursing homes--this time in the area of medication management.

In its revisions to the guidance of F-Tags #329 and #425, CMS provides organized educational information for the management and monitoring of residents' medication regimens. CMS has completely rewritten the interpretive guidelines to include clearly defined goals and helpful definitions for nursing homes.

CMS defines within those tags the circumstances that warrant the evaluation of residents and their medication regimens, gives reference and resource

information, and, of course, spells out the compliance criteria surveyors should use in making deficiency determinations. With this definition, the agency also raises its expectations for perfection.

Expecting perfection

These changes have substantial implications for providers from a survey perspective. When OBRA was implemented in October 1990, there was a great deal of buzz regarding the nursing home's responsibility for "perfection"--especially in regard to the wording of so many of the regulations which include "Each resident ..." as F329 does. Assured by CMS that perfection was not a requirement, nursing homes settled down--until enforcement took effect. Once again, the issue of perfection was raised but did not go away.

Having previously been a surveyor and state survey agency manager, I wonder about this expectation of perfection from the long-term care industry. The impending quality indicator survey (QIS) process coupled with the specificity and detail of the revised guidelines will raise the bar once again for the standard of care.

For instance, in the guidance for unnecessary drugs, medication management considers six factors, which require cumbersome documentation from a variety of resources for support, and surveyors will expect to see that documentation when they inspect your facility.

Specific surveyor focuses

Although most nursing homes have systems for documenting supportive information, a significant amount of staff education and monitoring will be necessary to bring documentation skills to the level of the expectations outlined in these guidelines. As they currently read, you can he cited for the failure to document the consideration that any negative event might have a relationship to a medication.

Of additional interest is the notation in F329, unnecessary drugs, regarding the intent of the surveyor's review of medication use. As stated, the review "is not intended to constitute the practice of medicine. However, surveyors are expected to investigate the basis for decisions and interventions."

Translated, this can mean that surveyors are not required or even expected to provide proof that a medication was the cause of an adverse consequence to cite a facility. If the possibility exists that medication caused an adverse event, and the facility cannot produce information, (i.e., proof,) that staff considered this possibility, surveyors will likely cite the facility. This leaves a broad expanse of interpretation to the discretion of the individual surveyor.

Questionable reporting

CMS chose to include some interesting statistics within these documents to illustrate the significance of the revised medication and pharmacy F-Tags. In the F329 section "Monitoring for Efficacy and Adverse Consequences" CMS quoted a 2005 American Journal of Medicine study, which reported that of 815 adverse drug events in healthcare facilities, 338 were preventable--a 42% rate of preventable errors. Only two of the facilities involved in the study were nursing homes.

Another study referenced in this document and published in the American Journal of Medicine is referenced in the overview of F425, pharmacy services. This study from 2000 (it's already seven years old) looks at 18 nursing homes in one state--a tiny proportion--and maintains that 51% of their adverse drug events were preventable, including 72% of which were characterized as fatal, life-threatening, or serious, and 34% of which were characterized as significant.

The statistical significance of these studies to long-term care nationally is certainly questionable, especially in light of the fact that these numbers have been included in a significant document with the capacity to make a profound impact on those with the responsibility to review a facility's compliance in these areas. Additionally, the pharmacy services document provides national numbers on the extrapolation of these findings quoting numbers of staggering proportions if the same events occur in "all U.S. nursing homes."

It seems curious that speculation of such magnitude would be deemed appropriate in this type of document.

Documentation: A surveyor magnet

Surveyors generally prefer paper-review functions. Paper review is concrete and easy, and surveyors can make copies of anything and everything.

Documentation in healthcare has always been a problem and will likely remain a problem. But make no mistake; documentation is as much a problem for surveyors as it is for providers, and surveyors enjoy tools that make their job easier.

Under the section of the F329 guidelines that addresses monitoring, CMS has included a table that lists Conditions/Symptoms, Tools, Applications, and References. This is helpful information. But the use of these tools as a part of facility policy makes it much easier for surveyors to identify what may appear to be gaps and inconsistencies in documentation.

Use these tools on a case-by-case basis to help you, especially when the situation is complicated and your resident will benefit from it. However, be diligent and cautious in your decisions to make these tools a part of your facility's policies and procedures. It would be wiser to use them as tools to learn to document in support of critical areas relevant to your individual resident.

Overall, your outcome will be significantly improved without making the surveyor's job easier.--Ellen Mullins, RN

Med management checklist

So how should you prepare your nursing home for successful surveys pertaining to the new guidelines for unnecessary drugs and pharmacy services?

Documentation is a recurrent theme throughout the revisions. Begin educating staff on the documentation requirements now. The documentation issues are cumbersome, difficult to learn, and must become habit.

The following are some documentation requirements you are expected to achieve for compliance and mechanisms for identifying them:

* Evaluate your current systems. Check to make sure all medications have a clearly documented indication for use, dose, and duration, including therapeutic goals.

* Consider medications as a cause any time a resident experiences a decline, functional or clinical change, difficulty, or negative event. Document your rationale.

* Always consider the possibility of nonpharmacological interventions before or in addition to the initiation of new medications directed toward stabilizing or improving a resident's mental, physical, or psychosocial well-being. Document your thinking and the resident's response.

* Document the resident's response to medications in terms of therapeutic goals or adverse consequences.

* Talk to your pharmacist. What is he or she able to do to support changes that will affect compliance issues?

* Educate and inform your physicians. Their cooperation and input is essential, not to mention their documentation of medical decisions, especially regarding indications, dose, duration, gradual dose reduction, and tapering.

* The Minimum Data Set coordinator should be involved in the evaluation of current facility systems and any changes necessary to achieve compliance, including documentation and nonpharmacological interventions. Pay particular attention to documentation expectations through the resident assessment instrument, with increased emphasis on the care plan.

* Check with your software company for programs available to assist you with documentation issues. Shop around if your current software provider is unable to assist you.

--Ellen Mullins. RN

Ellen J. Mullins, RN, BSN, CRNAC, is the CEO of Integrity Health Care Solutions, LLC, in Montgomery, AL. Services for long-term care facilities include education, computer assistance, mock surveys, HIPAA compliance, regulatory compliance, project development, and the analysis and evaluation of facility systems and processes. Ms. Mullins spent more than 13 years as a state surveyor, the State RAI Coordinator, and OASIS Education Coordinator for the State of Alabama. Contact her at 334/270-1199 or [e-mail].