SUBJECT:

Southridge Nursing and Rehabilitation Center,

Petitioner,

Health Care Financing Administration

FINAL DECISION ON REVIEW OF

ADMINISTRATIVE LAW JUDGE DECISION

Southridge Nursing and Rehabilitation Center (Petitioner) appealed a February 23, 2001 decision by Administrative Law Judge (ALJ) Jill S. Clifton sustaining the determination by the Health Care Financing Administration (HCFA) to impose a civil money penalty (CMP) of $6,100 on Petitioner.⁽¹⁾ See Southridge Nursing and Rehabilitation Center, DAB CR744 (2001) (ALJ Decision). HCFA had imposed the CMP based on a survey of Petitioner by the Iowa Department of Inspections and Appeals, which found Petitioner deficient in two participation requirements, constituting immediate jeopardy to one resident's health and safety. The ALJ found that Petitioner was not in substantial compliance with a Medicare participation requirement, set forth at 42 C.F.R � 483.25(h)(2). Further, although the ALJ agreed with Petitioner that it was not likely that the resident was in immediate jeopardy, she held that HCFA's determination that Petitioner's non-compliance was at an immediate jeopardy level was not clearly erroneous.⁽²⁾ In reaching her decision, the ALJ made four numbered findings of fact and conclusions of law (FFCLs) and other unnumbered findings.

For the reasons discussed below, we uphold the ALJ's finding that Petitioner was not in substantial compliance with a participation requirement. We further find that the facts of this case clearly warranted a finding that the resident was in immediate jeopardy because of failings and inaction by Petitioner's staff. Accordingly, we sustain the ALJ's imposition of a CMP of $6,100 on Petitioner.

The record here includes the record before the ALJ, the ALJ Decision, the parties' submissions on appeal, and the transcript of an oral argument held at request of Petitioner. Our standard of review on a disputed conclusion of law is whether the ALJ Decision is erroneous. See, e.g., Lake Cook Terrace Nursing Center, DAB No. 1745 (2000). Our standard of review on a disputed finding of fact is whether the ALJ Decision is supported by substantial evidence on the record as a whole. Id.

Applicable Regulations

HCFA determined that Petitioner was not in substantial compliance with Medicare participation requirements, finding that conditions at Petitioner's facility on October 4 - 5, 1997, constituted immediate jeopardy to the residents' health and safety.

For purposes of surveys of skilled nursing facilities like Petitioner, the regulations define "substantial compliance" as "a level of compliance with the requirements of participation such that any identified deficiencies pose no greater risk to resident health or safety than the potential for causing minimal harm." 42 C.F.R. � 488.301. "Immediate jeopardy" is defined as "a situation in which the provider's noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident." Id.

The participation requirement at issue here falls under the rubric of "quality of care" requirements, which share the same regulatory objective that "[e]ach resident must receive and the facility must provide the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the comprehensive assessment and plan of care." 42 C.F.R. � 483.25. The specific provision at issue was the following:

Accidents. The facility must ensure that -

(1) The resident environment remains as free of accident hazards as is possible; and

(2) Each resident receives adequate supervision and assistance devices to prevent accidents.

42 C.F.R. � 483.25(h).

For deficiencies constituting immediate jeopardy, the regulations provide that a CMP in the range of $3,050 to $10,000 per day may be assessed. 42 C.F.R. � 488.438(a)(1).

Before the ALJ, a facility must prove substantial compliance by the preponderance of the evidence, once HCFA has established a prima facie case that the facility was not in substantial compliance with one or more participation requirements. Hillman Rehabilitation Center, DAB No. 1611 (1997), aff'd Hillman Rehabilitation Center v. HHS, No. 98-3789(GEV), slip op. at 25 (D.N.J., May 13, 1999). However, HCFA's determination as to the level of noncompliance must be upheld unless the determination is clearly erroneous. 42 C.F.R. � 498.60(c)(2); see also Woodstock Care Center, DAB No. 1726, at 9 (2000).

Factual Background

The ALJ Decision contains a full discussion of the background, which we summarize here. ALJ Decision at 4 - 8; see also HCFA Ex. 1, at 1 - 4. Petitioner is a 82-bed skilled nursing facility located in Marshalltown, Iowa. HCFA imposed the CMP because of an incident that occurred in October 1997 involving one of Petitioner's residents. This resident, a male who was 41 years-old at the time, was diagnosed with multiple sclerosis. While functioning at a high cognitive level, the resident was physically unable to use his legs and was confined to a wheelchair which the resident used for self-mobility. In addition to his electric wheelchair, the resident had a lighter wheelchair which he used when family or friends took him on trips away from the facility. The resident was accustomed to using the electric wheelchair to exit Petitioner's building several times a day to smoke cigarettes at a picnic table area on Petitioner's grounds.

On the evening of October 4, 1997, members of Petitioner's staff noticed the resident at approximately 7:20 p.m. near the picnic table with his father, who was visiting. After his father left, the resident remained outside and left the picnic table area to get a better look at new construction underway on the northeast side of the facility. The resident guided his wheelchair outside the chain-link fence surrounding the perimeter of the northeast side of the facility. In maneuvering his chair around the fence, the resident got too close to a downward slope of approximately 30 degrees, and he was unable to prevent himself from rolling down the hill for about 23 feet to a flat weedy field. The resident employed a seatbelt in the wheelchair and the chair remained upright at all times. This occurred at approximately 8:00 p.m. The resident was unable to maneuver the wheelchair through the tall weeds and back up the hill.

After unsuccessfully calling for help (the resident suffered from a pre-existing condition of laryngeal spasticity), the resident lowered himself out of the wheelchair to the ground and into the weeds and went to sleep. The resident estimated that it was about 9:00 p.m. when he lowered himself out of the wheelchair.

Petitioner's staff first noticed the resident's absence at approximately 9:30 p.m. when he was not found in his room for his usual medications. At 9:30 the facility's Charge Nurse conducted a search of the facility and the outside picnic area for the resident. Calls were made to the home of the resident's mother and sister, listed as contact persons on the resident's clinical record, to inquire if the resident was with family or friends, but no one answered the calls. Further calls were made throughout the night, all unsuccessful at reaching anyone. The search of the facility and picnic area was repeated at 12:30 a.m. on October 5. No one noticed the presence of the resident's portable wheelchair in the facility. At that time the facility's Resident sign-out book was checked for the first time for the resident's name to see if he had signed out as he had in the past when relatives or friends took him outside the facility. Although Petitioner had a "Missing Resident" procedure in place, the Charge Nurse did not follow the procedure, believing that the resident was with family members or friends.⁽³⁾ The Charge Nurse called the Marshalltown police at 4:45 a.m. A police officer arrived at 5:00 a.m. and took a missing person report, followed by a 45-minute flashlight search around the facility with the Charge Nurse. The police officer further searched on his own until 6:30 a.m. with no success.

At approximately 5:30 a.m. a nurse's aide at the facility, in the first instance of adherence to the "Missing Resident" protocol, telephoned the Director of Nursing, who immediately called the facility administrator at home. The administrator then went to the home of the resident's father and determined that the resident was not there. When the administrator arrived back at the facility, he began another search of the area outside of the chain-link fence and found the resident asleep in the weeds at 6:30 a.m.

A medical examination revealed that the resident suffered no ill effects from spending the night outdoors, and the resident dismissed the seriousness of the situation, likening his experience to a "camping trip." The temperature the night of October 4, 1997 reached a low of 57 degrees. In the previous year the low temperature for that date was 39 degrees.

Discussion

In reaching her decision, the ALJ made four numbered findings of fact and conclusions of law (FFCLs). Two of the FFCLs are contested on appeal:⁽⁴⁾

1. Finding. Petitioner did not provide adequate supervision to prevent accidents between 9:30 p.m. on October 4, 1997 and 6:30 a.m. on October 5, 1997 [Tag F-324]. Consequently, Petitioner was not in substantial compliance with 42 C.F.R. � 483.25(h)(2).

3. Finding. HCFA's determination that Petitioner's noncompliance was at the level of immediate jeopardy was not clearly erroneous. 42 C.F.R. �� 488.301, 498.60(c)(2).

In discussing these findings, the ALJ found that the resident's rolling down the hill was not the result of inadequate supervision by Petitioner, and that Petitioner was not at fault for failing to block off the area from where the resident rolled and for failing to warn its residents about any potential danger related to the embankment. ALJ Decision at 9 - 10. The ALJ further found that the failure to follow the "Missing Resident" policy earlier than 9:30 p.m. on October 4, 1997, did not indicate a lack of adequate supervision by Petitioner. Id. at 10. Rather, the ALJ held that Petitioner's only deficiency under 42 C.F.R. � 483.25(h)(2) was its "inability to account for [the resident's] whereabouts, together with Petitioner's failure to attend properly to the task of locating and retrieving him." Id. at 19. Specifically, the ALJ found that the totality of events that transpired after 9:30 p.m. on October 4, 1997, amounted to a lack of adequate supervision by Petitioner. The ALJ's finding was based on the following:

• the failure to consider the "Missing Resident" policy at 9:30 p.m.;
• the failure to follow the "Missing Resident" policy;
• the failure to check the sign-out sheet until 12:30 a.m. on October 5, 1997;
• the failure to call the Director of Nursing until 5:30 a.m. on October 5, 1997;
• the failure to do more earlier to make contact with the last person known to have been with the resident;
• the failure to recognize the significance of whether the resident's manual wheelchair or his electric wheelchair was still in the facility.
  

ALJ Decision at 14.

The ALJ, however, found that the resident did not suffer any serious injury, harm or impairment from his experience and that the issue was, under the regulatory definition of "immediate jeopardy," whether it was likely that the resident would suffer injury, harm, impairment, or death as a result of Petitioner's failure to ensure that the resident received adequate supervision to prevent accidents. The ALJ cited with approval the following factors advanced by Petitioner to show that it was not likely, and that there was not a high probability, that the resident would suffer serious injury, harm, impairment, or death as a result of being outside the facility overnight:

• the resident suffered no harm or threat of harm from the outdoor exposure due to cold;
• the resident suffered no harm or threat of harm from missing his regular prescribed medications;
• the resident suffered no harm or threat of harm from the risk of acquiring bronchitis;
• the resident suffered no harm or threat of harm from leg spasms due to exposure;
• the resident suffered no harm or threat of harm from emotional trauma due to the exposure.
  

ALJ Decision at 19.

The ALJ stated, in what was essentially an unnumbered finding, that if Petitioner were required to prove by a mere preponderance of the evidence that the resident was unlikely, by spending the night outside the facility, to suffer serious injury, harm, impairment, or death, she would find that no immediate jeopardy existed. Id. The ALJ further found, however, that she could not substitute her own conclusion for that of HCFA and that she was constrained by 42 C.F.R. � 498.60(c)(2) to uphold HCFA's determination unless it was "clearly erroneous." Id. at 20. The ALJ stated that HCFA could reasonably find that there was immediate jeopardy when Petitioner was unable to account for the resident's whereabouts and failed to attend properly to the task of locating and retrieving him. Id.

On appeal, Petitioner argued that substantial evidence on the record as a whole supported a finding that Petitioner was in substantial compliance with 42 C.F.R. � 483.25(h)(2). Petitioner noted that the ALJ sustained only several points advanced by HCFA as bases for noncompliance with 42 C.F.R. � 483.25(h)(2), while rejecting numerous other HCFA allegations and finding that the resident suffered no actual harm. Petitioner asserted that the HCFA findings sustained by the ALJ have a common relationship, in that they all relate to the failure of Petitioner's staff to follow Petitioner's "Missing Resident" policy. According to Petitioner, a requirement to follow its "Missing Resident" policy stretched its obligation beyond the law. Petitioner contended that the failure to follow a written policy developed solely by Petitioner and reflected nowhere in the regulatory standards of care is not sufficient to make a prima facie case of noncompliance under the standards set forth in Hillman. Petitioner stated that there was no evidence that the risk of harm to the resident would have been reduced if Petitioner's staff had followed the policy, and that the goal of the policy to ensure that a system was in place to make an adequate, timely search for missing residents was met. Petitioner insisted that the adequacy of its supervision of its residents must include an element of reasonableness, and the event that triggered HCFA's finding of noncompliance was a single unforeseeable event that was dealt with reasonably and did not demonstrate neglect. Petitioner argued that the occurrence involving the resident did not prove a deficiency, but merely indicated the possibility of one. Therefore, according to Petitioner, the preponderance of the evidence shows that it was in substantial compliance with its duty of care under 42 C.F.R. � 483.25(h)(2).

Petitioner thus argued that the ALJ erred in her application of the clearly erroneous standard. Petitioner maintained that the ALJ's findings of fact significantly eroded the basis upon which the HCFA determination of noncompliance with 42 C.F.R. � 483.25(h)(2) was made, rendering the HCFA determination of immediate jeopardy erroneous.

Additionally, Petitioner argued that HCFA violated the regulatory requirement set forth at 42 C.F.R. � 488.434 in failing to notify Petitioner in its written Notice of Penalty of the factors considered in its determination. Specifically, Petitioner asserted that nowhere in HCFA's notice of the CMP imposed did HCFA state that it found immediate jeopardy or explain the basis for that determination. In the oral argument, Petitioner clarified this point, arguing that HCFA switched the basis for its determination of immediate jeopardy to the resident from actual harm to the likelihood of harm.

Petitioner stated that it "does not know what more it could have reasonably done," and that it "did exactly what they ought to do with respect to [the resident], and reacted reasonably under all the circumstances." Reply Brief at 7 and 8.

We disagree. While we agree that Petitioner was not at fault for the resident rolling down the incline, we hold that Petitioner's actions from 9:30 p.m. on fell far short of what was required.

Under the standards set forth in Hillman, once HCFA established a prima facie case that Petitioner was not in substantial compliance with 483.25(h)(2), Petitioner was required to prove substantial compliance by a preponderance of the evidence.

Petitioner argued that it was under no regulatory obligation to have a "Missing Resident" protocol and that it accordingly should not be held liable for its staff not having followed the procedures set forth in the protocol. While it may be true that there is no regulatory requirement for a skilled nursing facility to have a particular policy in place to locate missing residents, Petitioner's "Missing Resident" protocol is nonetheless evidence of what steps Petitioner considered necessary to fulfill its duty of care. In any event, it was incumbent upon Petitioner's staff to locate or attempt to locate the resident in as systematic and expeditious manner as possible. As the Board declared in Woodstock, "while the regulations do not make facilities unconditional guarantors of favorable outcomes, the quality of care provisions impose an affirmative duty to provide services . . . designed to achieve those outcomes to the highest practicable degree." At 25.

Petitioner's staff failed to meet that "affirmative duty." While searches were conducted of the facility and the grounds, the area below the hill was not searched. Tr. at 207. The presence of the resident's portable wheelchair, with the implication that he had not left the facility with family or friends, was not detected. The charge nurse did not consult the Resident sign-out book for three hours. The resident was missing for over seven hours before the police were notified. It is questionable how thorough the searches made by the staff in conjunction with the police were; while it is plausible that it was difficult to find the resident laying in weeds that were one to two feet high, there is no explanation for the failure to detect the resident's wheelchair which was standing upright beside him. The facility's administrator was not notified until 5:30 a.m., eight hours after the resident was first determined to be missing and the administrator was to be notified under the protocol.

The end result of the failure to follow the "Missing Resident" protocol was that the search for the resident was not appropriately intensified, with the resident spending a longer time outdoors exposed to the elements than was reasonably necessary.⁽⁵⁾ Accordingly, we find that substantial evidence in the record supports the ALJ's finding that Petitioner was not in substantial compliance with the condition of participation set forth at 42 C.F.R. � 483.25(h)(2).

The ALJ stated that she personally would not find immediate jeopardy present in this case, but that she was bound by the regulations to uphold HCFA's determination that immediate jeopardy was present unless that finding was clearly erroneous. For the reasons discussed below, we find that there is more than ample evidence in the record to support a determination that Petitioner's lack of supervision was likely to cause harm to the resident, so that the ALJ did not err in finding that HCFA's determination of immediate jeopardy was not clearly erroneous.

It is undisputed that: the resident was outside of the facility and not under Petitioner's supervision for approximately 11� hours, from approximately 7:00 p.m. on October 4 to 6:30 a.m. on October 5; Petitioner's staff only became aware of the resident's absence at 9:30 p.m. on October 4; Petitioner had a "Missing Resident" protocol in place in the event of such situations, but Petitioner's staff did not follow the procedures set forth in the protocol; Petitioner's staff did not consult the Resident sign-out book until 12:30 a.m. on October 5; Petitioner's staff did not call the police until 4:45 a.m. on October 5 to help search for the resident; and Petitioner's staff did not notify the Director of Nursing of the situation until 5:30 a.m. on October 5.

The result of all these events was that the resident lay outside on the ground for approximately 9� hours, wearing only a t-shirt, sweatpants, shoes and socks. It is true that the resident suffered no actual harm from his experience, but we question how the ALJ could have found that there was no likelihood of harm for the resident. The ALJ's conclusions apparently were based on the actual outcome of events, not on what potentially could have happened to the resident, the likelihood of harm he faced. The Board has held that the regulations do "not require any finding of actual harm to justify a determination that immediate jeopardy to residents exists." Woodstock at 38 (2000). Our review of the record shows that an examination of the totality of the circumstances present in this case justified a finding of immediate jeopardy.

It cannot be overemphasized that it was a totally fortuitous situation that the resident did not suffer any actual harm as a result of his spending the night outside. It was an unusually mild night for October in Iowa, although the resident stated that he was cold during the night. Hearing Tr. at 198. Clearly, if the temperature had been only marginally lower than what the parties stipulated the temperature was, 57 degrees, or if there had been precipitation, the resident, clad only in the clothing described above, would have suffered actual harm.⁽⁶⁾

It was likewise fortuitous that the particular medications that the resident was under physician orders to take nightly could be omitted once without any significant effects on his well-being.⁽⁷⁾ If the resident had been taking other medications, a missed dose might have resulted in actual harm.

Furthermore, while Petitioner made light of HCFA's suggestion that the resident might have fallen victim to a wild animal attack during the night, questioning whether the resident's "being outside overnight certainly put him at risk of being eaten by wolves or bears" (Oral Argument Tr. at 16), the fact remains that the resident's physical condition left him in an extremely vulnerable state, unable to fend for himself. Just because the resident fortuitously did not suffer any actual harm does not eliminate the likelihood that harm could have befallen him in the course of his time outside.

Thus, notwithstanding the ALJ's personal view that it was not likely the deficiency could have resulted in actual harm, we find that the ALJ correctly concluded that HCFA's determination of immediate jeopardy was not clearly erroneous. Any suggestions to the contrary in the ALJ Decision constitute harmless error.

As to Petitioner's argument that it was deprived of adequate notice and explanation of the basis for HCFA's determination that this was a case of immediate jeopardy, a review of the record shows that Petitioner first made this argument in its reply brief on appeal and never raised this issue in its request for review of the ALJ Decision or even before the ALJ. The Board's Guidelines for Review of Decisions of Administrative Law Judges Affecting a Provider's Participation in the Medicare and Medicaid Programs specifically provide that the "Board will not consider issues not raised in the request for review, nor issues which could have been presented to the ALJ but were not." � 4(c). We note, moreover, that HCFA's October 23, 1997 Notice of Penalty did reference the survey report, HCFA Form 2657 (HCFA Ex. 1), in which the areas of noncompliance were detailed with regulatory citations, and further stated that the conditions at the facility "constituted jeopardy to residents' health and safety." Thus, Petitioner had at a minimum general notice of the bases for HCFA's action and that "jeopardy" was involved. Moreover, in the parties' Joint Report of Readiness to Present Evidence for Adjudication of the Case, with cover letter dated October 4, 1999, the identification of legal issues included whether a determination of "immediate jeopardy" was warranted. As noted above, the regulatory definition of "immediate jeopardy" includes both actual or likely harm. Thus, Petitioner had ample notice and opportunity to contest the factors that were the basis for the HCFA determinations of noncompliance and a situation of immediate jeopardy at the hearing and in briefing before the ALJ. We therefore conclude that Petitioner was in no way prejudiced by any alleged failure by HCFA to explain more fully the basis for the CMP in the Notice of Penalty.

Conclusion

For the reasons discussed above, we sustain the imposition of a CMP of $6,100 on Petitioner. In doing so, we affirm those FFCLs to which no exceptions were made, and we sustain FFCL 1 and 2.

Judith A. Ballard

Donald F. Garrett

Marc R. Hillson
Presiding Board Member

1. Although HCFA has recently been renamed the Centers for Medicare & Medicaid Services, we use "HCFA" below since that acronym was used to refer to the agency at the time the actions at issue here were taken.2. The ALJ found that HCFA failed to establish a prima facie case that Petitioner was not in substantial compliance with the other deficiency cited in the survey, which involved the administration requirements set forth at 42 C.F.R. � 483.75. That finding of the ALJ was not contested on appeal.

3. Petitioner's "Missing Resident" protocol consisted of 11 steps, the first of which was notifying the facility's administrator, followed by a thorough search of the building and surrounding grounds, then if the search was unsuccessful notification of the next of kin and the local law enforcement agency. HCFA Ex. 2, at 131.

4. In its Notice of Appeal, Petitioner listed six specific exceptions to findings of fact by the ALJ, but all six exceptions were related to FFCLs 1 and 3. Specifically, Petitioner claimed
that -

1. The ALJ erred in finding that the failure to follow the directives of the facility's missing resident policy contributed to a lack of care under 42 C.F.R. �483.25(h)(2).
2. The ALJ erred in finding that the failure to do more to contact the last person known to have been with [the resident] contributed to a lack of care under 42 C.F.R. �483.25(h)(2).
3. The ALJ erred in finding that the failure to determine whether [the resident] was in his manual or electric wheelchair contributed to a lack of care under 42 C.F.R. �483.25(h)(2).
4. The ALJ erred in finding that Petitioner was not in substantial compliance with the 42 C.F.R. �483.25(h)(2) duty of care.
5. The ALJ erred in finding that HCFA's determination of immediate jeopardy was not clearly erroneous.
6. The ALJ erred in applying a clearly erroneous review where the basis of the deficiency found by HCFA was not supported in material aspects by her findings of fact as to the alleged deficiencies.

Notice of Appeal at 4 - 5.

5. HCFA referred to Petitioner's immediate firing of the Charge Nurse as recognition of the seriousness of the failure to follow the "Missing Resident" protocol. Petitioner objected to the use of any alleged remedial measures as evidence of a violation of standard of care. This event played no factor in our consideration of this appeal.

6. During the oral argument, Petitioner offered that the mildness of the night might have been a factor in Petitioner's staff not having conducted a more urgent search for the resident. Oral Argument Tr. at 20. Needless to say, we find troubling any suggestion that the diligence of a search for a missing resident would be dependent on the vagaries of the weather conditions.

7. The resident received nightly doses of trazadone, used for treatment of depression or insomnia, and metamucil, used for constipation. Hearing Tr. at 50 - 52.