SUBJECT:

Liberty Commons Nursing and Rehab - Alamance,

Petitioner,

Centers for Medicare & Medicaid Services.

DECISION

I sustain the determination of the Centers for Medicare & Medicaid Services (CMS) to impose civil money penalties against Petitioner, Liberty Commons Nursing and Rehabilitation - Alamance, as follows: $3,050 for each day of a period that began on September 19, 2004 and which ran through November 17, 2004; and $50 for November 18, 2004.

I. Background

Petitioner is a skilled nursing facility in North Carolina. Petitioner participates in the Medicare program. Its participation in Medicare is governed by sections 1819 and 1866 of the Social Security Act and by implementing regulations at 42 C.F.R. Parts 483 and 488.

A Medicare compliance survey of Petitioner was completed on November 18, 2004 (November survey). The surveyors found that Petitioner failed to comply with a Medicare participation requirement and determined that Petitioner's noncompliance was so egregious as to comprise immediate jeopardy for one of Petitioner's residents. CMS concurred with the survey findings and determined to impose remedies against Petitioner. Petitioner requested a hearing and the case was assigned to me for a hearing and a decision.

I held a hearing in Greensboro, North Carolina, on December 15, 2005. At the hearing, I received exhibits from CMS consisting of CMS Exs. 1-14. Transcript (Tr.) at 7. I received exhibits from Petitioner consisting of P. Exs. 1-11 and 13-50 (Petitioner did not offer P. Ex. 12). Tr. at 8-9. Additionally, I heard the cross examination of two witnesses whose written direct testimony was admitted as exhibits.

II. Issues, findings of fact, and conclusions of law

A. Issues

This case centers around the care that Petitioner gave to one of its residents, who is identified as Resident # 2 in the report of the November survey. CMS Ex. 1. Allegedly, Petitioner failed to provide this resident with adequate supervision and assistance devices to prevent accidents. CMS contends that failure by Petitioner to supervise and assist Resident # 2 contravened the requirements of 42 C.F.R. � 483.25(h)(2), which requires that a facility ensure that each of its residents receives adequate supervision and assistance devices to prevent accidents. CMS argues that Petitioner's noncompliance with this regulation extended from September 19 through November 18, 2004, and that the noncompliance from September 19 through November 17, 2004 put Resident # 2 at immediate jeopardy. According to CMS, Petitioner's noncompliance justifies the imposition of civil money penalties of $3,050 per day against Petitioner during the September 19 - November 17, 2004 period and $50 for November 18, 2004.

In deciding this case I address the following issues:

1. Did Petitioner fail to comply substantially with the requirements of 42 C.F.R. � 483.25(h)(2) during the September 19 - November 18, 2004 period?

2. If Petitioner was not in compliance with 42 C.F.R. � 483.25(h)(2), was CMS's determination clearly erroneous that, during the period that ran from September 19 - November 17, 2004, Petitioner's noncompliance comprised immediate jeopardy?

3. What civil money penalty amounts are reasonable?

B. Findings of fact and conclusions of law

I make findings of fact and conclusions of law (Findings) to support my decision in this case. I set forth each Finding below as a separate heading. I discuss each Finding in detail.

1. Petitioner failed to comply substantially with the requirements of 42 C.F.R. � 483.25(h)(2) during the period that ran from September 19 - November 18, 2004.

During the period between September and November 2004, Resident # 2 was an 87-year old individual who suffered from impairments which included, principally, Alzheimer's disease and osteoporosis. The resident was assessed as being alert but confused. P. Ex. 11, at 1. She ambulated with little or no assistance but needed the support of a walker. Id., at 1 - 2.

Resident # 2 was an elopement risk. As Petitioner acknowledged in its hearing request, the resident posed a "high risk for elopement as the result of her numerous medical and psychological ailments." Hearing request at 2. Petitioner's staff observed on many occasions that the resident was an elopement risk. CMS Ex. 2, at 6 - 7, 14, 17, 19, 27, 33, 35, 39, 42, 47.

Up until May 2003, Petitioner maintained a locked Alzheimer's unit in its facility for demented individuals and Resident # 2 resided there. Resident # 2 was transferred into the general resident population when Petitioner closed the unit. Resident # 2 began making elopement attempts almost immediately thereafter. Petitioner's pre-hearing brief at 6 - 7. Petitioner advised the resident's family members that they should consider moving the resident to another, more secure, facility. CMS Ex. 2, at 52. The family refused.

Each of Petitioner's exit doors was equipped with an electronic lock. A person could leave the facility through any of these doors by entering a code number into a keypad that was located adjacent to the door. CMS Ex. 13, at 5. Each door's electronic lock could be deactivated by operating a bypass switch, resembling an electric light switch, that was located next to each door. Id. With the exception of Petitioner's front door, none of the exits in Petitioner's facility was equipped with an audible alarm. Id., at 5 - 6. ⁽¹⁾ A person thus could leave the facility by any of the exit doors except the front door without triggering an alarm that would notify the staff that the door had been opened.

Resident # 2 eloped Petitioner's facility on numerous occasions between May 2003 and November 19, 2004. Her elopements included the following:

� On May 15, 2004, Resident # 2 was allowed to walk out of the facility by a visitor. P. Ex. 19, at 1. The resident was found subsequently in the parking lot of Petitioner's facility. Id.

� On June 23, 2004, the resident opened a facility doorway and stepped outside. The resident was apprehended by certified nursing assistants (CNAs) and returned to the facility. P. Ex. 20, at 1.

� On August 14, 2004, the resident eloped the facility and was returned by another resident's family member. P. Ex. 21, at 1.

� On September 19, 2004, the resident walked out a side door of the facility. The resident was found outside of the facility by workers. P. Ex. 22, at 1.

� On November 6, 2004, a member of Petitioner's staff discovered Resident # 2 outside of the facility, knocking on an exit door. The resident was admitted back into the facility. P. Ex. 23, at 1.

� On November 7, 2004, the resident was apprehended after walking out of the front door of Petitioner's facility. P. Ex. 24, at 1. On this occasion, the resident's elopement triggered her Wanderguard alarm. Two visitors to the facility observed the resident eloping and returned her to the facility. Id.

It is not clear how the resident managed to get through the facility's exit doors on each occasion that she eloped. At least once or twice, visitors let the resident out of the facility because they either mistook the resident for a visitor to the facility or assumed that the resident had permission to leave. P. Ex. 45, at 2; CMS Ex. 13, at 20 - 21. Eventually, however, the resident apparently learned how to deactivate the facility's electronic door system by flipping the exit door's deactivation switches. See P. Ex. 24, at 1. Thus, the resident learned how to let herself out of the facility without alerting anyone. Another resident asserted to have seen Resident # 2 flip a keypad deactivation switch on September 19, 2004 and exit the facility. CMS Ex. 13, at 11, 14 - 15. After the resident eloped on November 6, 2004, Petitioner's staff discovered that a deactivation switch had been flipped on the door through which the resident exited. CMS Ex. 2, at 39; CMS Ex. 13, at 15 - 16. On November 7, 2004, Resident # 2 was observed flipping a deactivation switch and then eloping from Petitioner's facility. CMS Ex. 2, at 50; CMS Ex. 13, at 16 - 17.

Petitioner seems to argue that, although Resident # 2 attempted to elope on numerous occasions, she never actually succeeded in doing so. According to Petitioner, on occasions when the resident eloped, her absence invariably would be noticed immediately and she would be returned to the facility promptly. Petitioner contends that there was no elopement because Resident # 2 was never exposed to hazards such as fear, confusion, exposure, or getting run over by a vehicle. Petitioner's brief at 5.

I do not find this assertion to be supported by the record. It is not clear from the record how long the resident was absent from the facility on several occasions when she eloped. P. Ex. 19 - P. Ex. 24. The record is more or less silent as to the amount of time that the resident spent outdoors on the occasions when she eloped. Id. On balance, the evidence supports a conclusion that Resident # 2 was successful more than once in leaving Petitioner's premises without being detected and, on several occasions, was found at a point in time subsequent to her escape by persons other than Petitioner's staff. And, Petitioner's assertions notwithstanding, when Petitioner left the facility, she went into exterior areas that were exposed to the elements and where there was automobile traffic (as, for example, in Petitioner's parking lot). That is elopement by any definition of the term.

A facility's responsibility to provide adequate supervision and assistance to its residents in order to protect them against accidents is not one of strict liability. A facility is not liable for unforeseeable events. A facility is responsible for identifying all accidents that are foreseeable, given each resident's condition and the facility environment, and taking all reasonable steps necessary to protect that resident from sustaining an accident.

Here, the risks to Resident # 2 were obvious and well known to Petitioner's staff. The resident was a frail, demented, and confused individual who was prone to eloping Petitioner's premises. Elopement exposed the resident to grave risks, including the terrain surrounding Petitioner's facility, the elements, the hazards of walking unsupervised, and exposure to motor vehicles. CMS Ex. 13, at 13 - 14. In light of that, the question becomes whether Petitioner undertook all reasonable measures to protect Resident # 2 from these known risks and hazards.

I find that it did not. There is no question that Petitioner made efforts generally to protect its residents from elopement-associated risks and hazards. And, it also took several steps that were specifically designed to protect Resident # 2 from such risks and hazards. However, the measures that Petitioner took were inadequate. More needed to be done by Petitioner to protect the resident; more could have been done, but Petitioner failed promptly to do what was necessary

As I discuss above, it is not entirely clear how, on various occasions prior to September 19, 2004, Resident # 2 managed to elope Petitioner's premises. But, on September 19, the resident was observed by another resident to flip the deactivation switch next to an exit door and simply walk out the door. CMS Ex. 13, at 11. That event put Petitioner's staff on notice that there was a flaw in its security system. Beginning on September 19, Petitioner's staff knew that Resident # 2 was capable of defeating the keypad locking mechanism on each of Petitioner's exit doors. P. Ex. 22, at 3. That knowledge imposed on Petitioner a burden to take reasonable and effective measures to prevent a recurrence.

However, Petitioner failed to do so. Petitioner did not change its door security system immediately despite knowing that Resident # 2 was capable of defeating it. Nor did it give heightened supervision to the resident that was sufficient to assure that she would not elope while unobserved. CMS Ex. 13, at 15. On November 6, 2004, Resident # 2 again walked out through an exit door. Staff determined that the deactivation switch next to the door was flipped. P. Ex. 23, at 2. On November 7, 2004 the resident again flipped a deactivation switch and walked out of the facility. P. Ex. 24, at 1. It was not until November 8, 2004 that Petitioner decided to order a supplemental alarm system that would be triggered by someone who attempted to flip a deactivation switch. That was not installed until November 16, 2004. CMS Ex. 13, at 17 - 19. ⁽²⁾

In its defense, Petitioner asserts that it engaged in numerous interventions that were designed to protect residents in general against the risk of elopement and to protect Resident # 2 in particular. Petitioner asserts that it had an anti-elopement policy that protected all of its residents against the risk of elopement. It contends that, as part of this policy, its staff conducted periodic elopement drills. Petitioner's brief at 9; P. Ex. 26; P. Ex. 41. The specific actions that the staff took to protect Resident # 2, according to Petitioner, included: having the resident wear a Wanderguard alarm; monitoring the resident's location at intervals as frequent as once every 15 minutes; discussing the resident's proclivities at staff meetings; redirecting the resident; offering her diversional activities; and providing medication adjustments to address the resident's agitation. Petitioner's brief at 8; P. Ex. 13; P. Ex. 38; P. Ex. 43, at 3 - 4; P. Ex. 44, at 3 - 4; P. Ex. 45, at 3; P. Ex. 46, at 1 - 2. ⁽³⁾

All of these actions were appropriate. But, they clearly were inadequate, individually and in sum, to protect the resident from a known risk. Petitioner's staff knew, by September 19, 2004, that Resident # 2 could elope the premises without detection by flipping the deactivation switch that was located next to each exit door. Yet, Petitioner did not address that problem with a more secure system until November 16, 2004.

Petitioner asserts that Resident # 2's apparent understanding that she could elope the premises of the facility by flipping a deactivation switch was not a foreseeable development. Petitioner argues that the resident's dementia made it highly improbable that she would have the capacity to learn how to use the deactivation switch and that, consequently, Petitioner should not be held accountable for such an unusual development. Petitioner's brief at 12.

The seeming ability of the resident to learn how to use the deactivation switch may be an unusual development given her dementia. But, unusual or not, it became evident to Petitioner's staff by September 19, 2004 that the Resident apparently had learned how to use the deactivation switch. ⁽⁴⁾ Even if Petitioner's staff could not have foreseen prior to September 19 that the resident might flip the deactivation switch, it knew from that date and thereafter that the resident had the capacity to do so. Consequently, Petitioner had forewarning of the resident's proclivities on and after September 19 and that knowledge imposed on Petitioner the duty to do something about the problem.

Petitioner also argues that the deactivation switches were mandated by the Life Safety Code. Petitioner's brief at 11. From this, it seems to assert that it should not be held accountable if a resident utilized a deactivation switch that was installed pursuant to a legal requirement to elope Petitioner's premises. But, obviously, the Life Safety Code did not prevent Petitioner from alarming the deactivation switches, which is the remedy that Petitioner finally opted to use in order to prevent additional elopements by Resident # 2.

Petitioner asserts additionally that, in seeking to protect Resident # 2 from her elopement proclivity, it had to balance the need for enhanced security with the needs of other residents for autonomy. According to Petitioner:

[A] nursing facility always must balance safety and security against limitations on resident autonomy, and this case posed the extreme complicating factor that Resident # 2's family insisted that she had to stay.

Petitioner's brief at 18. However, balancing the need for providing safety and security against the needs of other residents for autonomy cannot mean that a facility must ignore a hazard that obviously places a resident at risk. Here, Petitioner's staff knew that there was a patent flaw in its security system. Fixing that flaw was of paramount importance. Moreover, as was demonstrated by the solution opted for by Petitioner - alarming deactivation switches - Petitioner was ultimately able to protect Resident # 2 without unduly compromising the autonomy of other residents. ⁽⁵⁾

Petitioner also argues that its efforts to protect Resident # 2 were stymied consistently by the resident's family. Petitioner's brief at 29. What Petitioner means by this argument is that it recommended on several occasions after it closed its locked dementia unit that the resident be moved to a more secure facility, one which would have been better equipped than Petitioner was, to deal with the resident's elopement proclivity, and the family rejected these recommendations. I find that the failure of the resident's family to accept Petitioner's recommendations does not relieve Petitioner from responsibility for protecting Resident # 2. It may be true that other facilities were better equipped to protect the resident than was Petitioner. It may also be true that the family's refusal to accept Petitioner's recommendations put extreme pressure on Petitioner to come up with a solution to the resident's elopement attempts. But, that did not relieve Petitioner from the responsibility for protecting the resident so long as she resided on Petitioner's premises. Nothing in the record of this case shows that providing the resident with adequate protection was impossible. Indeed, the facility's ultimately successful solution to the problem of the resident's frequent elopements, alarming the deactivation switches, proves the contrary to be true.

CMS determined that Petitioner's noncompliance began on September 19, 2004, after Resident # 2 eloped for the first time by flipping a deactivation switch, and continued through November 18, 2004 (until November 17, 2004 the concompliance was at the immediate jeopardy level). I find this determination to be supported by the evidence.

It is entirely appropriate in this case to begin the period of noncompliance with September 19, 2004. That is the date when Petitioner first learned that Resident # 2 was capable of eloping its premises by flipping a deactivation switch. I agree with CMS that, once armed with that knowledge, Petitioner was under an obligation to do something immediately to rectify the problem.

What had to be done was to address the flaw in the security system. Petitioner failed to accomplish that until November 18, 2004. It ordered alarm-connected covers for the deactivation switches on November 8. These were not installed until November 16, and Petitioner's staff was not trained in their use until the 17^th. It was not until after November 18, 2004 that Petitioner came into substantial compliance. CMS's determination that the immediate jeopardy was not abated until November 17, 2004 is logical and is based on the fact that Petitioner did not completely address the flaw in its security system until that date.

2. CMS's determination that Petitioner's noncompliance was at the immediate jeopardy level from September 19 through November 17, 2004 was not clearly erroneous.

The term "immediate jeopardy" is defined at 42 C.F.R. � 488.301 to mean noncompliance which causes or is likely to cause serious injury, harm, or death to a resident or residents. CMS contends that Petitioner placed Resident # 2 in a state of immediate jeopardy from September 19, 2004, when Petitioner first learned that the resident could defeat its door security system, until November 17, 2004, when Petitioner installed alarmed covers on its keypad deactivation switches and trained its staff. I find this determination not to be clearly erroneous.

Immediate jeopardy exists when a facility's deficiencies cause serious injury, harm or death to a resident. It also exists when a resident is not harmed by a deficiency but where there is a likelihood that a resident will be harmed. A likelihood is more than a possibility that injury, harm, or death will occur to a resident. Innsbruck Health Care Center, DAB No. 1948 (2004). The potential for injury, harm, or death may justify the finding of a deficiency but not the finding of an immediate jeopardy level deficiency. Something more is needed to distinguish an immediate jeopardy level deficiency from one of lesser scope and severity. Likelihood is a measure of probability. A deficiency that potentially may cause serious injury, harm, or death rises to the immediate jeopardy level when it is more probable than not that it will cause serious injury, harm, or death.

CMS has a burden to prove, prima facie, that noncompliance is at the immediate jeopardy level. If it succeeds in meeting that burden the burden shifts to a facility to prove that a determination of immediate jeopardy is clearly erroneous. 42 C.F.R. � 498.60(c)(2).

I conclude that CMS proved in this case that there was a likelihood and not just a possibility that Resident # 2 would suffer serious injury, harm, or death, from continued elopements. Petitioner did not prove that CMS's determination was clearly erroneous.

Resident # 2 was, at the time of her elopements, elderly, frail, and seriously demented. Her elopements led her to places where the risk of injury was high. On at least one occasion, she wandered into a parking lot where there was vehicular traffic. In other instances, she was exposed to the elements. It is true that the resident was returned safely to Petitioner's premises after each elopement incident. But, I find that to have been fortuitous. There were no guarantees, nor was there a substantial probability, that the resident would be seen and safely returned once she got outside of the facility. To the contrary, the evidence satisfies me that the resident's exposure to the elements and to motor vehicles, coupled with her physical and mental state, created a strong probability that the resident would suffer extreme adverse consequences in the course of any of her several elopements on and after September 19, 2004.

Petitioner's principal argument against a finding of immediate jeopardy is that the resident suffered no actual harm because she was allegedly returned to the facility immediately after each elopement. I find this argument to be unpersuasive for two reasons. First, and as I discuss above, there is no conclusive evidence as to how long the resident was actually outside the premises during several of her elopements. It is speculative to say that she was returned immediately after each of her elopements. Second, the likelihood of harm would have been high even if the resident was outdoors only briefly on each occasion that she eloped. This individual was highly confused and frail. Walking on uneven terrain, in the vicinity of motor vehicles, put this resident at a very high probability of injury, harm, or death, even if her exposure to these hazards was brief.

3. Civil money penalties of $3,050 and $50 per day are reasonable.

Regulations prescribe the range of civil money penalties that may be imposed for deficiencies that are at or less than the immediate jeopardy level. The minimum daily civil money penalty for an immediate jeopardy level deficiency is $3,050. The minimum daily civil money penalty for a substantial, but non-immediate jeopardy level civil money penalty, is $50. 42 C.F.R. � 488.438(a)(1)(i), (ii).

Here, CMS imposed the minimum daily penalty amounts for the period when Petitioner was noncompliant. I find these penalty amounts to be reasonable as a matter of law. Consequently, penalties of $3,050 per day are reasonable for each day of the September 19 - November 17, period, when Petitioner's noncompliance was at the immediate jeopardy level. A penalty of $50 is reasonable for Petitioner's non-immediate jeopardy deficiency on November 18, 2004.

Steven T. Kessel

Administrative Law Judge

1. The parties have not made it clear whether the front door had an alarm that sounded when the door opened or whether it was wired so that it would trigger a body alarm such as a Wanderguard alarm when a resident who wore such a device attempted to exit the premises via that door. I infer that the latter may have been true, however, given that Resident # 2 wore a Wanderguard and it was triggered on one occasion when she eloped via the front door.

2. The supplemental alarm system consists of a box with a front cover that is placed over each deactivation switch. A shrill alarm is triggered if someone attempts to access the deactivation switch by opening the cover. CMS Ex. 13, at 18.

3. Evidently, the resident's Wanderguard alarm would trigger if the resident attempted to elope the facility via the front door. That occurred with the resident's November 7, 2004 elopement. However, the alarm apparently would not go off if the resident left the facility through other exits, as was the case on several occasions.

4. An alternative and equally plausible explanation for the resident's success in deactivating the keypad mechanism may be that, with each elopement beginning on September 19, 2004, the resident flipped the switch as a random act. However, if that is so, it simply underscores the vulnerability of Petitioner's security system.

5. As an alternative solution, Petitioner might have considered making the resident's Wanderguard alarm operative at all facility exits and not just the facility's front door. That would have imposed no burden on any of the other residents of the facility.