As part of ALN Consulting’s commitment to our legal partners, we introduce the second installment of our CMS Interpretive Guidelines series by diving into the revisions on the use of restraints. The guidelines include an explanation of the intent of the law, definitions of terms, and instruction on determining compliance with the law. The most important update to the Interpretive Guidelines regarding restraints prohibits their use in fall prevention. This update significantly impacts the defense of long term care facilities. These revisions must be studied thoroughly in order to build a firm case for the use or non-use of restraints. Continue reading for a thorough explanation of these revisions in the Interpretive Guidelines.

42 C.F.R. §483.13(a).

The CFR Regulation states, “The resident has the right to be free from any physical or chemical restraints imposed for purposes of discipline or convenience, and not required to treat the resident’s medical symptoms.” Relevant definitions in the Interpretive Guideline include:

Chemical Restraint: any drug that is used for discipline or convenience and not required to treat medical symptoms.

Convenience: any action taken by the facility to control a resident’s behavior or manage a resident’s behavior with a lesser amount of effort by the facility and not in the resident’s best interest.

Discipline: any action taken by the facility for the purpose of punishing or penalizing residents.

Freedom of movement: any change in place or position for the body or any part of the body that the person is physically able to control.

Medical Symptom: an indication or characteristic of a physical or psychological condition.

Physical Restraints: any manual method or physical or mechanical device, material, or equipment attached or adjacent to the resident’s body that the individual cannot remove easily which restricts freedom of movement or normal access to one’s body.

Removes easily: means that the manual method, device, material, or equipment can be removed intentionally by the resident in the same manner as it was applied by the staff (e.g., side rails are put down, not climbed over) considering the resident’s physical condition and ability to accomplish objective (e.g., transfer to a chair, get to the bathroom in time).

Regulation Tag F222 Guidance on Restraints

The main principal in the Interpretive Guideline is that restraints may not be used for staff convenience, and the only acceptable use of a restraint is to treat a medical symptom, with a physician order. The order itself is not justification to use a restraint, but must be “viewed in the context of the resident’s condition, circumstances, and environment.”  In addition, as a measure of last resort restraints can be used to protect the safety of the resident or others for a brief period of time. The facility may not use restraints in violation of the regulation solely based on a legal surrogate or representative’s request or approval.

When a restraint has been used, the surveyor must determine if the facility followed a systematic process of evaluation and care planning prior to using restraints, and if the plan of care was consistently implemented.

Surveyor “Probes” in facility use of Restraints

The defense team can use the “probes” or questions posed by the Interpretive Guidelines for surveyors in cases which involve restraints:

• What are the medical symptoms that led to the consideration of the use of restraints?
• Are these symptoms caused by failure to:
  • Meet individual needs in accordance with the resident assessments
  • Use rehabilitative/restorative care?
  • Provide meaningful activities?
  • Manipulate the resident’s environment, including seating?
• Can the causes of medical symptoms be eliminated or reduced?
• If the causes cannot be eliminated or reduced, then has the facility attempted to use any alternatives in order to avoid a decline in physical functioning associated with the restraint use?
• If alternatives have been tried and deemed unsuccessful, does the facility use the least restrictive restraint for the least amount of time? Does the facility monitor and adjust care to reduce the potential for negative outcomes while continually trying to find and use less restrictive alternatives?
• Did the resident or legal surrogate make an informed choice about the use of restraints? Were the risks, benefits, and alternatives explained?
• Does the facility use the CAA’s to evaluate the appropriateness of restraint use?
• Has the facility reevaluated the need for the restraint, made efforts to eliminate its use and maintained residents’ strength and mobility?

Updates to the Interpretive Guidelines

The most recent update to the Interpretive Guidelines for restraints was published in November 2014. The examples of facility practices that met the definition of restraint was noted to be “not limited to” the list. Also, in discussion of side rails, the addition of “assist with physical functioning” was added as an acceptable use.

The most important update to the Interpretive Guideline stated, “Falls do not constitute self-injurious behavior or a medical symptom that warrants the use of a physical restraint. Although restraints have been traditionally used as a falls prevention approach, they have major, serious drawbacks and can contribute to serious injuries. There is no evidence that the use of physical restraints, including but not limited to side rails, will prevent or reduce falls. Additionally, falls that occur while a person is physically restrained often result in more severe injuries (e.g., strangulation, entrapment).”

This update has implications in the defense both of the use or non-use of restraints, as well as in matters involving falls. When understood and implemented, these interpretive guidelines can be crucial in the defense of long term care facilities.

In conclusion, the successful defense of long term care facilities relies on a thorough understanding of the CMS Interpretive Guidelines. With our expertise, ALN Consulting can advise your legal team on how to best navigate the complicated CMS Interpretive Guidelines to support your legal team’s defense. Let us help you decipher the latest revisions of the Interpretive Guidelines and strengthen your long term care case.

References

1. Harris, Rick E. (2015). How to Use the CMS Surveyor Guidance to Craft a Winning Defense [Presentation at the DRI LTC/SNF Seminar].
2. Centers for Medicare & Medicaid Services. (2015). State Operations Manual – Appendix PP – Guidance to Surveyors for Long Term Care Facilities. Retrieved 01/04/16.

When defending cases against long-term care facilities, the Interpretive Guidelines become the canon by which the operations of a facility are judged. Like most law, long-term care regulations must be scrutinized through interpretation. Understanding the background and application of the Interpretive Guidelines can help build solid claims for litigation. As part of ALN Consulting’s commitment to our legal partners, we explain the Interpretive Guidelines and outline the importance of their application to strengthen your legal team’s expertise.

How are Nursing Homes regulated?

The Omnibus Budget Reconciliation Act of 1987 (OBRA ’87) and the Balanced Budget Act of 1997 (BBA ’97) require the Federal Centers for Medicare and Medicaid Services (CMS) to create regulations that govern practices in long-term care and skilled nursing facilities. The regulations resulting from OBRA and BBA are divided into two parts.

First, the regulations are stated in the U.S. Code of Federal Regulations (CFR) and referred to as “F-tags.” The second part of the regulation requires the agency responsible for enforcing the regulation to derive the Interpretive Guidelines. The Interpretive Guidelines should include an explanation of the intent of the law, definition of terms, and instructions on determining compliance with the law.

Who are the surveyors and how are the Interpretive Guidelines used?

Long-term care facilities receiving Medicare or Medicaid funds must be surveyed approximately once a year, and no less than 15 months. In almost all cases, these surveys are performed by state employees who use federal regulations to inspect facilities. Since the surveys are performed by state employees, the Interpretive Guidelines can be found in the State Operations Manual (SOM). The SOM provides guidance to each state on all aspects of state health care operations. Appendix PP to the SOM applies to long-term care and skilled nursing facility surveys.

Since Interpretive Guidelines are not included in the CFR, they do not have the force of law. However, they are still considered definitive by the CMS regarding what each regulation means. While not as authoritative as “standard of care,” the Interpretive Guidelines have a tremendous bearing on a long-term care liability case.  The Interpretive Guidelines are designed to assist surveyors in understanding the CFR requirements, applying those requirements consistently, and suggesting pathways for inquiry. The CMS continually produces revisions of the Interpretive Guidelines for surveyors’ use in nursing homes. State and federal surveys use the newest improvements that are backed by evidence.

Examples of Interpretive Guidelines

Appendix PP of the SOM covers long-term care operations and lists each CFR “F-tag,” followed by the Interpretive Guidelines, which include definitions of terms and questions for the surveyors to consider during the survey. For example, let’s examine a short Interpretive Guideline for dietary personnel staffing:

F362

483.35 (b) Standard Sufficient Staff

• The facility must employ sufficient support personnel competent to carry out the functions of the dietary service

Interpretive Guidelines: §483.35(b)

“Sufficient support personnel” is defined as enough staff to prepare and serve palatable, attractive, nutritionally adequate meals at proper temperatures and appropriate times and support proper sanitary techniques being utilized.

Procedures: §483.35(b)

For residents who have been triggered for a dining review, do they report that meals are palatable, attractive, served at the proper temperatures and at appropriate times?

Probes: §483.35(b)

• Sufficient staff preparation: Is food prepared in scheduled timeframes in accordance with established professional practices?
• Observe food service: Does food leave kitchen in scheduled timeframes? Is food served to residents in scheduled timeframes?

Standing alone, the CFR statement could be interpreted differently by individual surveyors of different states and personal experiences. However, the Interpretive Guideline provides concrete questions for the surveyor to determine if the federal regulation has been met.

Types of Surveys – Implementation of Interpretive Guidelines

In addition to annual surveys, nursing homes receiving Medicare or Medicaid funds are also subject to complaint surveys at any time the state survey agency or the CMS chooses. An annual or complaint survey can result in federal citations against the facility, which require the nursing home to create a plan of correction and submit it to the survey agency. The survey agency then verifies the correction, usually by revisiting the nursing home. These follow up visits can also result in additional citations.

Each problem, or deficiency, found is given a rating for “severity” and “scope,” or an “s/s” score on a scale of A to L, the latter of which is the most severe. For instance, a facility has a complaint survey based on a resident’s fall-induced fracture. The surveyor finds failure to ensure adequate supervision in order to prevent accidents, and rates the “s/s” as “G,” (defined as fairly severe) since the resident sustained a fractured hip. The facility submits a plan to correct the deficiency and the facility is re-surveyed a month later. The follow-up survey justifies removal of the immediate jeopardy, but the facility is not in full compliance due to a failure to complete the quality assurance related to staff monitoring, analysis of monitoring results, and a development and implementation of their plan. The facility is re-surveyed two weeks later and found to be in complete compliance.

Sanctions can be imposed on nursing homes that fail to meet requirements. State imposed sanctions can include citations and fines, bans on admission, and appointment of temporary managers. The facility’s license can also be suspended or revoked. If a nursing home is certified under CMS, federal sanctions can include directed plans of correction, directed in-service trainings, state monitoring, and/or denial of payment for new admissions, civil fines, and termination of Medicare or Medicaid payments. All nursing homes federally regulated under the CMS are listed under datasets created by the CMS called the “Five Star Nursing Home Quality Rating System.”

How to use Interpretive Guidelines in Nursing Home Litigation

Litigators defending long-term care and skilled nursing facilities can use CMS’s guidance to surveyors to help strengthen their arguments against liability. Consulting the Interpretive Guidelines could demonstrate that a facility intervened with numerous, appropriate interventions, in accordance with the guideline(s), but still received a poor outcome. Using a facility’s compliance with the Interpretive Guidelines could strengthen the claim that the outcome was likely unavoidable. In many cases, plaintiffs attempt to use the regulations and survey results to make “standard of care” arguments and sweeping claims against the care rendered by nursing home staff in a particular case, making it imperative to understand the basis of their argument.

Applying the Interpretive Guidelines in order to strengthen a claim requires expert knowledge and time-consuming research. With more than 127 collective years of legal experience and familiarity with the CMS Interpretive Guidelines, ALN’s nurse consultants serve as a unique partner for legal teams in nursing home litigation. Utilizing legal nurse consultants familiar with the CMS Interpretive Guidelines and skilled in survey analysis will help bolster the defense team’s understanding of these issues in the case and improve the defensibility of the claim.

References

1. Harris, Rick E. (2015). How to Use the CMS Surveyor Guidance to Craft a Winning Defense [Presentation at the DRI LTC/SNF Seminar].
2. Thomas, David R. (2006). The New F-tag 314: Prevention and Management of Pressure Ulcers. In Clinical Practice in Long Term Care (pp523-524). St. Louis, MO: AMDA.
3. Centers for Medicare & Medicaid Services. (2015). State Operations Manual – Appendix PP – Guidance to Surveyors for Long Term Care Facilities. Retrieved 11/20/15