SUBJECT:

Britthaven of Goldsboro,

Petitioner,

Centers for Medicare & Medicaid Services.

I sustain the determination of the Centers for Medicare & Medicaid Services (CMS) to impose a civil money penalty of $3050 against Petitioner, Britthaven of Goldsboro.

I. Background

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

Petitioner was surveyed for compliance with Medicare participation requirements in September and October 2004. On the basis of these surveys CMS determined that Petitioner failed to comply substantially with the participation requirement that is stated at 42 C.F.R. � 483.25(h)(1). This regulation mandates that a facility must ensure that the resident environment remains as free of accident hazards as is possible. CMS found that Petitioner failed to comply with the requirement on a single day, October 1, 2004. On that date a resident eloped from Petitioner's facility through an unguarded door. CMS determined that Petitioner's noncompliance was so egregious as to constitute immediate jeopardy for Petitioner's residents. It determined to impose a civil money penalty of $3050 for the alleged noncompliance.

Petitioner requested a hearing and the case was assigned to me for a hearing and a decision. The parties then agreed that the case could be tried based on their written submissions. Each party submitted proposed exhibits, briefs, and reply briefs. CMS's proposed exhibits are CMS Ex. 1 - CMS Ex. 19. Petitioner's proposed exhibits are P. Ex. 1 - P. Ex. 8. I receive all of the parties' proposed exhibits into evidence.

II. Issues, findings of fact and conclusions of law

A. Issues

The issues in this case are whether:

1. On October 1, 2004, Petitioner failed to comply substantially with the requirements of 42 C.F.R. � 483.25(h)(1);

2. If Petitioner failed to comply substantially with the requirements of 42 C.F.R. � 483.25(h)(1), its noncompliance was so egregious as to place residents of Petitioner's facility at immediate jeopardy; and

3. A civil money penalty of $3050 is reasonable as a matter of law.

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. On October 1, 2004, Petitioner failed to comply substantially with the requirements of 42 C.F.R. � 483.25(h)(1).

There is little, if any, dispute about the facts of this case. Construction workers were performing renovations to Petitioner's facility on October 1, 2004. These workers were employed by a contractor who had been retained by Petitioner to perform renovations. Petitioner's management and staff instructed the contractor and its employees not to use a particular door, located on Petitioner's "300 hall" for entrance and exit from the facility. Notwithstanding, the contractor's employees propped the door open for easier access to the work site. During the day a resident, identified as Resident # 1, eloped through the open door. She was found subsequently, sitting in a car that was in Petitioner's parking lot.

The resident had numerous impairments including dementia, paranoid delusions, and osteoporosis. P. Ex. 8. The resident was observed by Petitioner's staff to have an unsteady gait and to require assistance when ambulating. CMS Ex. 10, at 36, 37, 43, 48. In the months prior to October 2004 the resident was often wheelchair bound. CMS Ex. 11, at 10. She was an obvious fall risk and had fallen on more than one occasion while residing at Petitioner's facility. CMS Ex. 11, at 19, 20. Petitioner's staff assessed her as having severely impaired cognitive skills. CMS Ex. 10, at 7, 42, 47. The resident had both short- and long-term memory impairment and was frequently confused as to time and place. Id. at 35, 42, 47; CMS Ex. 11, at 3, 7, 9, 13. The resident had a history of wandering within Petitioner's facility and had expressed a desire to leave the facility. Resident # 1 was assessed as presenting a high risk for wandering. CMS Ex. 10, at 22, 24, 26, 36, 43, 48. At times the resident was observed to be agitated in conjunction with her wandering behavior. CMS Ex. 11, at 21.

Resident # 1 was one of 87 demented residents in Petitioner's facility. CMS Ex. 8, at 1. Thirteen additional residents had diagnosed psychiatric impairments other than dementia and depression. Id.

These essentially undisputed facts establish a strong prima facie case that Petitioner failed to comply with the requirements of 42 C.F.R. � 483.25(h)(1). The regulation imposes on a facility a duty to eliminate all accident hazards that are reasonably foreseeable. Petitioner was under an obligation to make sure that access to the exterior was not unrestricted and unsupervised because unrestricted access to the exterior of Petitioner's facility was an obvious accident hazard for a large percentage of Petitioner's residents. The presence of so many demented, psychiatrically, and/or physically impaired residents in Petitioner's facility made it foreseeable that unrestricted access to the exterior of the facility would place them at risk. The environment beyond Petitioner's doors poses an obvious hazard to these individuals. At a minimum, the possibility that any of these residents might leave the premises unsupervised and undetected would put them at risk for injury from motor vehicle traffic and exposure to the elements.

Petitioner plainly was aware of the risk. That is made evident by the fact that it instructed the renovation contractor and its employers not to use the "300 hall" entrance to the facility. But, Petitioner's duty to its residents did not end with simply telling the contractor not to use a particular door. Beyond that, Petitioner had an obligation to ensure that the contractor and its employees carried out Petitioner's instructions.

The prima facie evidence establishes that Petitioner plainly did not fulfill that obligation. Obviously, Petitioner failed to make sure that the contractor and its employees did not use the "300 hall" door. That is made evident by the fact that, on October 1, 2004, the door was propped open by the contractor and left open long enough for Resident # 1 to elope the premises undetected. That failure by Petitioner is, on its face, a failure to comply with the requirements of 42 C.F.R. � 483.25(h)(1).

Petitioner makes three arguments to support its assertion that it should not be held accountable for its failure to ensure that the "300 hall" door remained shut. First, it contends that it implemented an appropriate safety plan to protect its residents from elopements. Second, it contends that Resident # 1 - whatever her proclivities when she first came to Petitioner's facility - was not actively manifesting any interest in wandering on October 1, 2004. Petitioner argues that it should not be held accountable for what it contends is the unforeseen possibility that the resident would wander out of the facility on that date. Finally, Petitioner asserts that, as a matter of law, it should not be held accountable for the contractor's failure to follow its instructions. According to Petitioner, the contractor was an independent entity whose actions were beyond Petitioner's ability to control.

I find these arguments not to be persuasive. I do not take issue with Petitioner's assertion that it implemented a safety plan consisting of restricting the contractor's employees access to its facility to one set of entry doors and instructing these employees to only use those doors and no others for purposes of entrance and exit from the facility. Petitioner's reply brief at 3. But, that plan was inadequate. Most obviously, it failed to ensure that the contractor's employees acted according to Petitioner's instructions. Petitioner has not offered persuasive evidence showing that it monitored the contractor closely after it issued additional instructions about the use of exit doors. Indeed, the weight of the evidence supports a contrary inference. The fact that a door had been propped open for ease of entrance and exit by the contractor's employees should have been evident to Petitioner's staff. The fact that they failed to notice the open door is grounds for me to infer that Petitioner's staff was not closely monitoring the contractor's activities.

As for Resident # 1, Petitioner contends that, by July 2004, the resident's wandering behavior had decreased to minimal wandering. Petitioner's reply brief at 8. Petitioner argues that it was not under a duty to provide the resident with extra surveillance or supervision given the recent diminishing of her urge to wander. I disagree with this argument. Minimal wandering does not equate to no risk of wandering. Petitioner knew that the resident had a history of wandering and that her dementia made her confused. That should have put Petitioner on notice that the resident required careful supervision even if her wandering activity had decreased recently.

Moreover, the risk posed by the open exit door was a general risk to the residents in Petitioner's facility, and in particular to those who suffered from dementia or from other psychiatric impairments. The opened exit door on the "300 hall" on October 1, 2004, was a hazard to all of Petitioner's residents and not just to Resident # 1. The evidence in this case establishes that Petitioner failed its residents generally. The fact that Resident # 1 was the resident who eloped does not mean that other residents were better protected by Petitioner.

Finally, Petitioner argues that, because of its legal relationship with its contractor, it cannot be held strictly or vicariously liable for the contractor's acts. Petitioner's reply brief at 9. This argument fails because under Medicare regulations it is Petitioner who assumes ultimate responsibility for the care and safety of its residents. Petitioner may not delegate that obligation nor may it shirk it by assigning blame to a third party. The fact that a contractor was at work on Petitioner's premises on October 1, 2004, meant that Petitioner had to do everything that was within its power to ensure that the contractor did not breach Petitioner's security system. That included providing whatever supervision of the contractor and its employees may have been necessary to ensure they did not leave open doors that were supposed to be kept shut. If necessary, Petitioner's staff should have patrolled its exits while the contractor was on premises and taken the responsibility to shut any doors that the contractor's employees left open. The unrebutted evidence in this case establishes that Petitioner failed to discharge that duty to its residents.

I do not conclude that a facility is strictly liable for the mal- or misfeasance of its contractor. It is conceivable that a contractor, or one of its employees, might do something that is unforeseeable and, so, beyond the ability of a facility to anticipate or control. But, that is certainly not the case here. Keeping the "300 hall" exit door closed was an act that Petitioner foresaw as being necessary to protect its residents and it was something that Petitioner could control, either directly, or through careful supervision of its contractor.

2. CMS's determination that Petitioner's noncompliance was at the immediate jeopardy level is not clearly erroneous.

An immediate jeopardy level deficiency is one that causes, or is likely to cause, serious injury, harm, impairment, or death to a resident. 42 C.F.R. � 488.301. In any case where immediate jeopardy is at issue, CMS has the burden of coming forward with sufficient prima facie evidence to show that immediate jeopardy was present. The burden on a facility to disprove a determination of immediate jeopardy that is supported by prima facie evidence is very heavy. A facility may overcome a prima facie case of immediate jeopardy only by proving that CMS's determination was clearly erroneous. 42 C.F.R. � 498.60(c)(2).

The evidence offered by CMS establishes a prima facie case that Petitioner's noncompliance on October 1, 2004, was at the immediate jeopardy level. The evidence shows a likelihood of serious injury, harm, impairment, or death to one or more of Petitioner's residents as a consequence of an opened exit door and the resulting probability that a resident or residents would wander into unsafe areas.

To establish immediate jeopardy it is not necessary to show that a resident or residents sustained serious injury, harm, impairment, or died as a result of a deficiency. Immediate jeopardy exists also where there is no proof that a deficiency has actually harmed a resident but where the deficiency is likely to cause serious injury, harm, impairment, or death to a resident. 42 C.F.R. � 498.60(c)(2); Innsbruck HealthCare Center, DAB No. 1948 (2004). Likelihood is a measure of probability. A consequence is likely where it is more probable than not that it will occur.

Here, the prima facie evidence establishes a likelihood that serious injury, harm, impairment, or death to a resident would result from Petitioner's noncompliance. That evidence shows that, on October 1, 2004, Petitioner's security was breached by an opened exit door. That gave residents opportunity to exit the premises unsupervised. For residents who were demented, psychiatrically impaired, and/or frail, the opportunity to leave undetected made it likely that one or more of them might be injured, harmed, impaired, or die. Residents had access to areas that were exposed to the elements and to motor vehicles. These were individuals who were extraordinarily vulnerable to the consequences of such exposure. Resident # 1, for example, was physically frail and was so demented that she was unaware of her location or the time of day.

Petitioner did not establish CMS's determination to be clearly erroneous. Petitioner argues that Resident # 1 was outside of its premises for only a short period of time before her absence was discovered, she was found, and was returned to the facility unharmed. That may be so. But, given her frail state and dementia, and the condition of the many other demented and frail residents in Petitioner's facility, even exposure to the dangers of the outside world for a short period of time made adverse consequences, including serious injury, harm, impairment, or death likely, even if they did not eventuate. Petitioner and its residents were lucky that no one was seriously injured, harmed, impaired, or died. But, beating the odds is not a measure of the severity of noncompliance in this case.

Petitioner argues also that there are no specific facts of record that establish a likelihood that Resident # 1 would suffer a serious injury upon exiting Petitioner's facility. Petitioner's reply brief at 11. I disagree. Resident # 1's dementia and frailty made her a likely - not a speculative - candidate for serious injury, harm, impairment, or death in the event of her eloping from Petitioner's facility. The evidence establishes that Resident # 1 was exceedingly confused and frail. She was disoriented as to place, meaning that she did not know where she was. She was noted by Petitioner's staff to be very unsteady on her feet and had fallen at least twice in the months prior to October 2004.

Petitioner also characterizes CMS's contention that residents' unsupervised exposure to the premises outside of the facility created a likelihood of serious injury, harm, impairment, or death to these residents as being a per se rule that "any elopement outside the facility constitutes immediate jeopardy simply because of the inherent dangers which might befall a resident if he or she is able to elope." Petitioner's reply brief at 11. This, according to Petitioner, is mere speculation as to what might happen in the event of an elopement rather than an analysis of what is likely to happen.

I do not find this argument to be persuasive. CMS's analysis is grounded on substantial evidence, Petitioner's contentions notwithstanding. The evidence establishes that Petitioner had many residents who were extremely vulnerable to the risks posed by unsupervised exposure to the outside world. Moreover, those risks were more than hypothetical. Petitioner's facility opened on to a parking area where there was vehicular traffic and that traffic, in turn, exited on to a street. It is not speculative to conclude, given the facts of this case, that mentally impaired and frail residents - such as Resident # 1 - who eloped from Petitioner's premises were likely to be seriously injured, harmed, impaired, or to die as a consequence. Resident # 1, for example, had fallen previously while presumably under the close supervision of Petitioner's staff. On October 1, 2004, she was allowed to enter a world in which she had no supervision, but where the risks of falling were immeasurably magnified. The probable outcome of her elopement or of similar events involving other residents is evident.

3. A civil money penalty of $3050 is reasonable as a matter of law.

The minimum daily civil money penalty amount that may be imposed for a deficiency that is at the immediate jeopardy level is $3050. 42 C.F.R. � 488.438(a)(1)(i). In this case CMS determined to impose the minimum allowable penalty. That is reasonable as a matter of law.

Steven T. Kessel

Administrative Law Judge