SUBJECT:

JFK Hartwick at Edison Estates,

Petitioner,

Centers for Medicare & Medicaid Services

DECISION

I decide that a basis exists for imposing civil money penalties against Petitioner, JFK Hartwyck at Edison Estates. I find that Petitioner failed to comply substantially with a Medicare participation requirement during the period that began on March 27, 2000 and which ran through April 3, 2000. I find not to be clearly erroneous the determination by the Centers for Medicare & Medicaid Services (CMS, formerly known as the Health Care Financing Administration or "HCFA") that Petitioner's noncompliance posed immediate jeopardy to residents of Petitioner. However, I do not find to be reasonable CMS's determination that civil money penalties in amounts of $5,000 per day should be imposed against Petitioner for each day of the March 27 - April 3, 2000 period. I impose civil money penalties in amounts of $3,050 per day for each day of this period.

I. Background

Petitioner is a long-term care facility that is located in Edison, New Jersey. It participates in the Medicare program and is subject to the laws and regulations which govern the participation of long-term care facilities in Medicare. Petitioner was surveyed on March 23 and 27, 2000, by surveyors employed by the New Jersey State Department of Health and Senior Services (New Jersey State survey agency). These surveyors concluded that Petitioner had failed to comply substantially with two of the conditions of participation that governed its participation in Medicare. They concluded additionally that Petitioner's noncompliance with these conditions was so egregious as to constitute immediate jeopardy for Petitioner's residents. CMS accepted these conclusions and determined to impose civil money penalties against Petitioner in amounts of $5,000 per day for each day of a period that began on March 27, 2000 and which ran through April 3, 2000.

Petitioner requested a hearing and the case was assigned to me for a hearing and a decision. CMS moved for summary disposition, submitting a brief and a total of 40 exhibits (HCFA Ex. 1 - HCFA Ex. 40) in support of its motion. Petitioner cross-moved for summary disposition. It also submitted a brief and nine exhibits (P. Ex. 1 - P. Ex. 9) as well as the written declarations of two individuals, Renee Lake and Sandra Accetta. Neither CMS nor Petitioner argued that there was any need to present testimony or other evidence in person.

Neither party has objected to my receiving into evidence any of the exhibits that were submitted in support of their respective motions. Therefore, I receive into evidence HCFA Ex. 1 - HCFA Ex. 40. I also receive into evidence P. Ex. 1 - P. Ex. 9. Additionally, I identify Ms. Lake's declaration as P. Ex. 10 and Ms. Accetta's declaration as P. Ex. 11, and I receive these two documents into evidence.

II. Issues, findings of fact and conclusions of law

A. Issues

The issues are whether:

1. It is appropriate to decide this case based on the parties' written submissions;

2. Petitioner failed to comply substantially with any Medicare participation requirement during the period which began on March 27, 2000 and which ran through April 3, 2000;

3. CMS's determination that Petitioner's noncompliance was at the immediate jeopardy level is clearly erroneous; and,

4. Civil money penalties of $5,000 per day 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 separately numbered heading. I discuss each Finding in detail.

1. It is appropriate to decide this case based on the parties' written submissions.

Both CMS and Petitioner style their motions as motions for summary disposition. These are somewhat inaccurate characterizations of what the parties are asking for. Summary disposition is appropriate in a case where there are no disputed issues of material fact and where the only disputed issues involve questions of law or application of law to undisputed facts. There appear to be disputed issues of fact in this case. For example, there is a dispute as to whether a resident who is referred to by both parties as Resident # 3 was wearing a Wanderguard - a device that is designed to alert a facility when a resident makes an unauthorized attempt to leave a facility's premises - on March 20, 2000, when the resident eloped from Petitioner's premises. There is also a dispute as to when Petitioner may have corrected any errors in the way in which its staff was implementing precautions against elopement.

I find that it is appropriate to decide this case based on the parties' written submissions, not because there are no disputed issues of material fact, but based on the parties' desire that the case be decided without an in-person hearing. The presence of a disputed fact issue in a case does not necessarily mean that an in-person hearing is required in order to decide that issue. Parties are always free to ask that their cases be decided based on written submissions in lieu of in-person testimony.

2. Petitioner failed to comply substantially with the requirements of 42 C.F.R. § 483.25(h)(2) during the period which began on March 27, 2000 and which ran through April 3, 2000.

The New Jersey State survey agency surveyors found at Tag 324 of the survey report they prepared that Petitioner failed to comply substantially with the requirements of 42 C.F.R. § 483.25(h)(2). HCFA Ex. 5. This regulation requires that a facility must provide each resident with "adequate supervision and assistance devices to prevent accidents."

The regulation does not require a facility to be free of all accidents. It does not impose strict liability on a facility for accidental injuries that a resident may sustain. Woodstock Care Center, DAB No. 1726 (2000). What it requires of a facility is that it take all reasonable measures to prevent accidents. A facility has a high obligation to ensure that its accident prevention measures are adequate. Koester Pavilion, DAB No. 1750 at 24 (2000). However:

in ensuring adequate supervision . . . a facility is not required to do the impossible or be a guarantor against unforseeable occurrences, but is required to do everything in its power to prevent accidents.

Id. The regulation imposes on a facility the obligation to develop policies that identify foreseeable risks to residents and which implement protocols and procedures that are designed to minimize those risks. It requires facilities to plan and implement care for individual residents in a way that is designed to minimize their risk of sustaining accidents. And, it requires a facility to train and supervise its staff so as to minimize the possibility of accidents resulting from staff errors.

The allegations that Petitioner did not comply substantially with the requirements of 42 C.F.R. § 483.25(h)(2) relate to the care that Petitioner gave to three of its residents, Resident # 1, Resident # 2, and Resident # 3. CMS alleges that Petitioner failed to give Residents #s 1 and 2 adequate supervision or care to prevent these residents from falling. CMS asserts that Petitioner failed to provide Resident # 3 with adequate supervision to prevent that resident from eloping Petitioner's facility.

I do not find that CMS established a prima facie case that Petitioner provided inadequate supervision to Resident #s 1 and 2. But, the evidence pertaining to the care that Petitioner gave Resident # 3 shows there were flaws in the system that Petitioner devised to protect against elopement. From this evidence, I conclude that Petitioner was not complying substantially with the requirements of 42 C.F.R. § 483.25(h)(2) during the March 27 - April 3, 2000 period.

a. Resident # 1

Resident # 1 suffers from Alzheimer's disease. She is unable to move about in bed unassisted. HCFA Ex. 5 at 4. The evidence offered by CMS establishes that Resident # 1 sustained a fall on March 18, 2000. Id. On that date, the resident was found on the floor of her room lying on the right side of her bed. Id. The resident sustained a laceration to her forehead. She was transferred to a hospital emergency room for treatment of the laceration. Id.

Petitioner investigated the incident. HCFA Ex. 20. It concluded that the nursing assistant who was responsible for providing care to Resident # 1 gave inconsistent explanations for the resident's fall. It terminated the nursing assistant's employment on March 31, 2000. Id.

The foregoing evidence does not amount to a prima facie case that Petitioner failed to provide adequate supervision of Resident # 1 in order to prevent the resident from sustaining an accident because it does not provide a basis for me to infer that Petitioner should have taken precautions that Petitioner failed to take. It establishes only that the resident sustained an accident. CMS offered no evidence to show that the resident was at risk for injury as a consequence of Petitioner's failure to provide adequate supervision of the resident.

I may infer that the nursing assistant who provided care to Resident # 1 was in some manner negligent in providing care to the resident from the fact that the nursing assistant gave inconsistent explanations of the events that led up to the resident's fall. See HCFA Ex. 20. In hindsight, it might be inferred that the nursing assistant provided inadequate care. But, there is no evidence that the assistant was inadequately trained, or supervised.

b. Resident # 2

On February 29, 2000, Resident # 2 was injured while being transferred from bed via a Hoyer lift. HCFA Ex. 5 at 4. A nursing assistant was getting the resident out of bed with the aid of the lift when the lift slipped, and the resident became frightened, slipping to the floor. HCFA Ex. 23 at 1 - 2. The resident sustained a fracture of the right leg.

A Hoyer lift is a device that is used for transferring individuals who are unable to move without assistance. One nursing assistant was operating the lift at the time of the accident. HCFA Ex. 23 at 1-2. Petitioner's internal policy was to require two nursing assistants to operate the lift. See HCFA Ex. 8 at 2. However, the manufacturer of the Hoyer lift does not suggest that more than one person is necessary to operate the lift.

I do not find that CMS established a prima facie case that Petitioner failed to comply with the requirements of 42 C.F.R. § 483.25 in providing care to Resident # 2. There is no question that the resident sustained an accident. It may also be concluded from the fact that only one nursing assistant was operating the Hoyer lift at the time that the accident occurred that the lift was being operated in violation of Petitioner's internal policy at the time of the accident. But, this evidence does not show that Petitioner provided insufficient training to the nursing assistant or supervised either the nursing assistant or the resident inadequately.

It is not unreasonable to infer that Petitioner wanted two staff members to operate the Hoyer lift because it was concerned for the safety of its residents. Given that, a failure by Petitioner to train its staff, disseminate its policy, or correct a known noncompliance of its policy would be a basis for me to conclude that Petitioner was not providing adequate supervision. But, there is no basis to find Petitioner liable if the evidence only establishes an isolated error by a member of Petitioner's staff which occurred despite - and not because of - the way that Petitioner instructed and supervised its staff.

In other cases I have found that a facility is liable under 42 C.F.R. § 483.25(h)(2) for failing to address accident hazards of which it was aware. For example, in Woodstock, I found that the facility did not provide adequate supervision to its residents based on evidence which showed that the facility failed to take remedial measures despite repeated episodes of elopements and resident-against-resident assaults. The facility knew that there were problems with assaults and elopements but did not address those problems. In another case, Sonogee Rehabilitation and Living Center, DAB No. 754 (2001), I held that a facility failed to provide supervision to its residents in order to prevent accidents where the facility knew that a resident was prone to elope the facility through a window but where it failed to secure the window in order to prevent further elopements. Again, the facility knew that a problem existed but did not address that problem.

By contrast, the evidence presented by CMS in this case does not show that Petitioner knew or should have known that its staff was not complying with its directive concerning use of the Hoyer lift. CMS did not produce anything to show that the episode involving Resident # 2 was more than an isolated failure by one employee on Petitioner's staff to comply with facility policy.

Furthermore, there is no evidence that the staff's failure to follow the policy concerning use of the Hoyer lift was the proximate cause or even an indirect cause of the accidental injury to Resident # 2. CMS has not made any showing that the resident fell from the Hoyer lift as a consequence of only one staff person operating the lift.

c. Resident # 3

Resident # 3 suffers from Alzheimer's disease and has a tendency to wander. Petitioner's staff knew that the resident was an elopement risk. HCFA Ex. 27. Prior to March 20, 2000, the resident had made several attempts to elope the facility. Id. at 2-4. On December 2, 1999, the resident managed to get outside of Petitioner's facility. Id. at 6. On that date, Petitioner's staff assessed the resident as wandering on a daily basis. HCFA Ex. 29 at 3.

Petitioner's staff concluded after the December 2, 1999 elopement attempt that Resident # 3 presented such an obvious elopement risk that she should be transferred to a locked unit for demented residents that is located within Petitioner's facility. Additionally, the resident was made to wear a Wanderguard bracelet.

However, on March 20, 2000, Resident # 3 again briefly eloped Petitioner's facility. On this occasion, the resident managed to elope at the end of a lunch period when she was taking lunch with other residents in the facility's dining room which is located outside of Petitioner's locked unit. Apparently, the resident managed to evade the attention of Petitioner's staff for enough time so that she could elope the premises. There is a dispute as to whether the resident was wearing a Wanderguard at the time of her elopement. CMS contends that she was wearing the device and Petitioner asserts that it had been removed due to the fact that the resident had been trustworthy in the days preceding March 20, 2000.

I find that the evidence offered by CMS is prima facie evidence that Petitioner's staff failed adequately to supervise Resident # 3 in order to prevent the resident from eloping Petitioner's premises. The staff was aware of the elopement risks presented by the resident. The evidence offered by CMS shows that the staff failed to watch the resident closely in circumstances where the resident had the opportunity to elope. The evidence offered by CMS also is prima facie proof that Petitioner did not comply with the requirements of 42 C.F.R. § 483.25(h)(2) in providing care to Resident # 3. It shows that Petitioner knew that Resident # 3 was at risk for accidental injury if she eloped from Petitioner's premises yet failed to take adequate measures to protect the resident.

Petitioner argues that it took all measures that were reasonable to prevent Resident # 3 from eloping. According to Petitioner, the resident eloped despite the implementation of these measures and not because of any failure of Petitioner or its staff to provide adequate supervision to the resident. Additionally, it contends that it had legitimate reason to believe that, as of March 20, 2000, Resident # 3 no longer presented an elopement threat. Petitioner argues that the resident had adjusted well to Petitioner's facility and that her behavior was so appropriate that the staff social worker suggested that the resident no longer needed to wear a Wanderguard.

I do not find these arguments to be persuasive. Resident # 3 had a relatively lengthy history of elopement attempts. Petitioner was sufficiently concerned about the elopement risk posed by the resident that it had her reside in a special locked unit of Petitioner's facility. Given that, Petitioner's staff should have been vigilant for the possibility that the resident might attempt to elope any time the resident was outside of the locked unit. The staff plainly failed to satisfy that responsibility on March 20, 2000, when the resident eloped at the end of the lunch period.

There is a question of whether Petitioner's lack of supervision of Resident # 3 merely shows an isolated failure by staff to supervise a resident or shows some broader problem. That an isolated mistake in providing care may have occurred may not be sufficient basis to conclude there was an overall failure by Petitioner to comply with the requirements of 42 C.F.R. § 483.25(h)(2). Here, I infer that the error in not supervising Resident # 3 did show a failure by Petitioner's staff to understand the need to supervise closely those residents who were prone to wander or elope. The evidence is that Petitioner's staff misjudged the elopement risk posed by the resident and so let down their guard sufficiently that the resident was able to elope. From that I infer an overall lack of understanding by Petitioner's staff of the degree of supervision that might be necessary to protect residents against eloping.

My conclusion that Petitioner failed to comply with the requirements of 42 C.F.R. § 483.25(h)(2) as of March 20, 2000, does not resolve the issue of whether a basis exists to find Petitioner deficient under that regulation as of March 27, 2000, the beginning date of the period for which CMS determined to impose civil money penalties. Petitioner argues that it corrected before March 27, 2000, any deficiencies that it may have manifested in supervising residents who are elopement risks.

No basis would exist to take remedial action against Petitioner during the period that ran from March 27, 2000 through April 3, 2000, if Petitioner was no longer out of compliance with the regulation on those dates. However, it is reasonable to presume that if a facility is out of compliance with a participation requirement on a particular date, it remains out of compliance until it offers credible evidence that it has attained compliance or until CMS certifies that it has attained compliance. The burden falls on Petitioner to prove that it attained compliance with 42 C.F.R. § 483.25(h)(2) prior to April 3, 2000.

I do not find that Petitioner established that it attained compliance prior to April 3, 2000. Petitioner avers, through the declaration of Sandra Accetta, that it "promptly" implemented remedial measures after Resident # 3's elopement. P. Ex. 11. Ms. Accetta recites a series of remedial measures that Petitioner took. Id. I have no reason not to believe Petitioner's assertion that it implemented these remedial measures. However, Petitioner has not established precisely when it implemented them. Saying that it implemented them "promptly" is insufficient to show that they were implemented prior to April 3, 2000.

3. CMS did not prove a prima facie case that Petitioner failed to comply substantially with the requirements of 42 C.F.R. § 483.70(c)(2).

The New Jersey State survey agency surveyors found at Tag 456 of their survey report that Petitioner failed to comply substantially with the requirements of 42 C.F.R. § 483.70(c)(2). This regulation requires a facility to:

[m]aintain all essential mechanical, electrical, and patient care equipment in safe operating condition.

The gravamen of the allegation concerning Petitioner's alleged failure to comply with the regulation is that Petitioner did not maintain its residents' Wanderguard bracelets adequately. Specifically, the surveyors alleged that Petitioner did not check Resident # 3's Wanderguard for effective functioning within 90 days of its activation as is required by the manufacturer's guidelines for the device. HCFA Ex. 5 at 6.

Petitioner has not denied the assertions of fact which are the basis for the deficiency allegations at Tag 456. But, it argues that it may not be found to have failed to comply with the regulation because a Wanderguard bracelet is not an essential item of equipment within the meaning of 42 C.F.R. § 483.70(c)(2) and, therefore, failure to maintain a Wanderguard bracelet does not comprise a failure to maintain an essential piece of equipment.

I find Petitioner's argument to be persuasive. The regulation does not define what is meant by an essential item of equipment. The common and ordinary definition of the word "essential" is something that is "indispensable or basic." Webster's II New College Dictionary 384 (2d Ed. 1999). I find this definition to be a reasonable definition of the word "essential" in 42 C.F.R. § 483.70(c)(2) in the absence of any evidence that the Secretary of the Department of Health & Human Services intended that the word had some special meaning. CMS did not make a prima facie showing that a Wanderguard bracelet is indispensable or basic equipment.

From the facts that are before me, it is apparent that a Wanderguard is a device which assists a facility's staff in assuring that a resident who wears the device does not leave a defined area in the facility. It is clearly helpful in keeping track of a resident's whereabouts. It may enable a facility to get by with using less staff than would be necessary to observe and keep track of residents if the device were not in use. But, there is no evidence that a Wanderguard is indispensable or basic equipment. A facility may keep track of an elopement-prone resident without placing a Wanderguard on that resident. Close observation of the resident would fulfill the same function as is performed by the Wanderguard.

Thus, a Wanderguard bracelet, if maintained correctly, gave Petitioner's staff a useful tool for keeping track of Resident # 3's whereabouts. But it was not an essential device for doing so. Consequently, failure to maintain the device adequately cannot be grounds for finding that Petitioner failed to comply substantially with the requirements of 42 C.F.R. § 483.70(c)(2).

4. Petitioner did not prove to be clearly erroneous CMS's determination that Petitioner's failure to comply with the requirements of 42 C.F.R. § 483.25(h)(2) constituted immediate jeopardy for Petitioner's residents.

Noncompliance with a participation requirement that constitutes "immediate jeopardy" is a situation in which the noncompliance:

has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident.

42 C.F.R. § 488.301. A finding of an immediate jeopardy level deficiency need not be predicated on a finding of actual harm. Immediate jeopardy may be present where there is a likelihood that a facility's noncompliance may cause serious injury, harm, impairment, or death to a resident. Id. A facility that challenges a CMS determination of immediate jeopardy level noncompliance has the burden of proving that the determination is clearly erroneous. 42 C.F.R. § 498.60(c)(2).

Petitioner did not prove to be clearly erroneous CMS's determination that Petitioner's failure to comply with the requirements of 42 C.F.R. § 483.25(h)(2) constituted an immediate jeopardy level deficiency. The evidence shows a likelihood that residents who eloped from Petitioner's facility could suffer serious injury, harm, impairment, or death. Resident # 3 and other residents who might elope are individuals who are at risk for serious injury if alone in the community unsupervised. Resident # 3, for example, suffers from Alzheimer's dementia. It is not difficult to envision how such an individual might suffer injury or death if allowed to wander unsupervised along a public right of way. Resident # 3 was found lying in a ditch with an abrasion on her head. HCFA Ex. 34 at 2, 5. Petitioner argues that the resident did not suffer serious harm from this episode. That may be true. But, as I have explained, actual harm is not a necessary element of a finding of an immediate jeopardy level deficiency.

5. Civil money penalties of $5,000 per day are not reasonable. Civil money penalties of $3,050 per day are reasonable.

The range of civil money penalties that CMS may impose for an immediate jeopardy level deficiency is from $3,050 to $10,000 per day for each day that the deficiency persists. 42 C.F.R. § 488.438(a)(i). Where penalties fall within this range depends on factors which may include: a facility's history of noncompliance; its financial condition; its culpability; the seriousness of a deficiency or deficiencies; and, the relationship of one deficiency to another. 42 C.F.R. § 488.438(f); 42 C.F.R. § 488.404(b), (c) (incorporated by reference into 42 C.F.R. § 488.438(f)(3).

CMS asserts that penalties of $5,000 per day are reasonable. It bases this argument on the alleged seriousness of Petitioner's failure to comply with participation requirements and on Petitioner's past compliance history. According to CMS, the elopement of Resident # 3 was a consequence of a systematic failure by Petitioner to assure the effectiveness of its residents' Wanderguard bracelets. CMS asserts also that, in 1998, Petitioner was cited for deficiencies that were not at the immediate jeopardy level but which caused residents to experience harm.

I am not persuaded that civil money penalties of more than $3,050 per day are reasonable. First, although I am not minimizing the seriousness of Petitioner's failure to provide adequate supervision of its residents to prevent elopements from occurring, it is evident that Petitioner's deficiency is nonetheless less serious than CMS depicts. CMS averred that there were multiple failures by Petitioner to comply with participation requirements. In fact, and as I discussed above, at Findings 2 and 3, Petitioner's deficiency pertained only to its staff's failure to provide adequate supervision in order to prevent elopements by its residents. Furthermore, I am not persuaded that Resident # 3's elopement is a consequence of Petitioner's failure to maintain Wanderguard bracelets. The evidence is equivocal at best as to whether the resident even was wearing a Wanderguard on March 20, 2000. The elopement of the resident appears to have been the consequence of a lapse of supervision of the resident by Petitioner's staff.

Second, CMS has offered no evidence which explains how the deficiencies that Petitioner previously may have manifested relate to the deficiency that is at issue here. There is no suggestion in this case that the inadequate supervision that Petitioner may have shown in March 2000 was a continuation of some pattern of inadequate supervision that was evident previously.

Thus, the evidence in this case establishes that there was a single event of deficient care at Petitioner's facility which does not appear to be related to any historical pattern of failures of care by Petitioner. Given that, it is not reasonable to impose civil money penalties which exceed the minimum amount that is required for immediate jeopardy level deficiencies.

Steven T. Kessel

Administrative Law Judge