SUBJECT:

Osceola Nursing & Rehabilitation Care Center,

Petitioner,

Health Care Financing Administration

DECISION

Osceola Nursing and Rehabilitation Center (Petitioner) requested a hearing to challenge a civil money penalty (CMP) of $40,000 imposed on it by the Health Care Financing Administration (HCFA).

For the reasons set out in detail below in my findings and conclusions, I decide that HCFA had the authority to impose the CMP because Osceola was not in substantial compliance with the cited participation requirements for nursing facilities during the period from March 6, 1998 through and including March 9, 1998. I also conclude that the non-compliance created a situation of immediate jeopardy and that the CMP of $10,000 per day was reasonable.

The following summarizes my decision. A resident suffering from Alzheimer's disease eloped from Osceola on a wintry day and died of exposure. Subsequent investigation indicated that although she was wearing a functional alarm bracelet on her ankle, she was able to exit a front door with a sensor mat because the alarm system could be defeated by several methods. The resident had been in the facility for just over one month and had attempted to elope numerous times and frequently expressed an intention to leave the facility. She was also confused about her placement at the facility. She had been assessed as needing monitoring and the facility had a policy for responsible staff to be aware of residents' whereabouts at all times. Nevertheless, the nursing notes for the four days before her death showed no evidence documenting monitoring efforts and no staff members directly responsible for her care testified as to how they implemented any monitoring regime. On the day of her death, no staff person recalled having seen her after lunch (with the exception of one aide who noticed the resident standing in her bathroom) until she was found unconscious in the snow at 5:15 p.m. In light of the egregious nature of Petitioner's failure to implement any systematic plan to supervise the resident and monitor her whereabouts in the face of plain danger to her, and in light of the ultimately fatal results, the CMP is warranted.

Procedural history

Petitioner originally filed its hearing request by letter dated March 31, 1998. The case was then assigned to Administrative Law Judge (ALJ) Mimi Hwang Leahy. On May 25, 1999, ALJ Leahy dismissed the case for abandonment. Osceola Nursing and Rehabilitation Center, DAB CR595 (1999). The dismissal was overturned, and the case remanded for hearing and reassigned to me. Osceola Nursing and Rehabilitation Center, DAB No. 1708 (1999).

The hearing was held on February 29 and March 1, 2000. HCFA presented as witnesses the following individuals: Paul Glen Berry (who visited Osceola as an Iowa Department of Inspections and Appeals (IDIA) surveyor); Cheryl Kluza (who accompanied him); and Rose Dittmer (program coordinator at IDIA). Osceola presented as witnesses the following individuals: Troy Anderson (facility administrator); James Mitchell III (safety director for Osceola's parent company); Albert Jones, Jr. (director of environment services for the same company); and Peggy Munson (nurse consultant for the same company).

HCFA submitted eight exhibits (HCFA Ex.) which I admitted without objection as HCFA Exs. 1- 8. Transcript of Hearing (Tr.) at 11-12. Osceola submitted eight exhibits (P. Ex.), but counsel for Osceola noted that some were duplicative of HCFA's exhibits and sought admission only for three of them. Without objection, I admitted those as exhibits P. Exs. 2, 5, and 6.

Applicable legal provisions

The Social Security Act (Act) provides authority for HCFA to impose CMPs of up to $10,000 per day on facilities that are not in substantial compliance with Medicare and Medicaid participation requirements. Sections 1819, 1919, and 1866(b)(2) of the Act.

"Substantial compliance" is defined to mean -

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. Regulations limit the amount of CMPs imposed to amounts set at $50 increments within two ranges. 42 C.F.R. § 488.438(a). The upper range, applicable to deficiencies determined to have presented an immediate jeopardy to residents' health and safety, is between $3,050 and $10,000 per day. 42 C.F.R. § 488.438(a)(i).

The deficiencies for which Osceola was cited fell under two regulatory requirements. The first falls under the rubric of quality of care which requires generally 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 requirement with respect to which Osceola was alleged to be deficient reads as follows:

(h) Accidents. The facility must ensure that -

* * *

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

42 C.F.R. § 483.25(h)(2)

The second deficiency alleged was failure to comply with the requirement that a facility "must be administered in a manner that enables it to use its resources effectively and efficiently to attain or maintain the highest practicable physical, mental, and psychosocial well-being of each resident." 42 C.F.R. § 483.75.

The same set of facts were cited in support of finding deficiencies in both requirements at the immediate jeopardy level. In essence, HCFA determined that Osceola failed to adequately supervise a resident resulting in her accidental death and that this failure demonstrated that the facility was not administered effectively to provide the requisite quality of care to prevent such accidents.

Standard of review

HCFA bears the burden of producing a prima facie case that it had a basis to impose the CMP on Petitioner. In order to prevail, Petitioner must then prove by a preponderance of the evidence on the record as a whole that it was in substantial compliance with the requirements at issue. See Hillman Rehabilitation Center, DAB 1611 (1997), aff'd, Hillman Rehabilitation Center v. U.S., No. 98-3789 (GEB) (D.N.J. May 13, 1999).

In cases involving immediate jeopardy, the regulations provide that (assuming the provider fails to show that it was in substantial compliance with the cited requirement), the level of noncompliance determined by HCFA must be upheld unless the facility shows that the immediate jeopardy determination was clearly erroneous. 42 C.F.R. § 498.60(c).

Background

The following summary sets out the undisputed factual background in this case. I make findings about specific contested details and explain the inferences I draw from the facts in later sections. Osceola is a dually-participating skilled nursing facility (SNF) located in Osceola, Iowa. On March 9, 1998, one resident (to whom I shall refer as R. 10) exited the facility and was found unconscious, lying in the snow about 448 feet from the facility. She could not be resuscitated and was declared dead at the hospital. The medical examiner determined the cause of death to be hypothermia due to exposure.

On March 10, 1998, Osceola reported this incident to IDIA which initiated an investigation that afternoon. IDIA completed its investigation on March 13, 1998 and reported on its statement of deficiencies (also referred to as HCFA Form 2567L) that immediate jeopardy to resident health and safety existed at Osceola for a period of four days. At the time, 80 other residents were housed at the facility, of whom nine were identified as having a propensity to wander. IDIA recommended a CMP of $10,000 per day. HCFA adopted this recommendation and Osceola's request for review followed.

Issues

The issues presented in this appeal are:

1. Whether Osceola was not in substantial compliance with one or both of the cited requirements;

2. If so, whether HCFA's determination that the non-compliance created immediate jeopardy was clearly erroneous;

3. If not, whether the immediate jeopardy was present on each of the four days alleged by HCFA; and

4. Whether the CMP imposed was reasonable in amount.

Findings of fact, conclusions of law, and analysis

Below, in bold face, I set out findings of fact and conclusions of law (FFCLs) supporting my decision in this case. More detailed analysis of my reasons follows each FFCL or set of related FFCLs.

1. Osceola was not in substantial compliance in that it failed to provide adequate supervision to prevent R. 10 from eloping.

A. The degree of supervision called for in the case of R. 10 depended on Osceola's notice of the very high risk of elopement and of the seriousness of the consequences of an elopement under the circumstances present.

Osceola argued that HCFA improperly cited it for failure to comply with the requirement to provide adequate supervision to prevent accidents because HCFA merely presumed lack of supervision from the bare fact that R. 10 died after eloping. Petitioner's Brief (P. Br.) at 18. Citing Iowa tort law, Osceola argued that the facility had no notice that the alarm mat was defective and therefore could not be held strictly liable for an accident resulting from a defect not known or discoverable through the exercise of reasonable care. Id. at 15-18 and cases cited therein. HCFA denied that it was applying a strict liability for accidents in holding Osceola deficient in its care of R. 10.

The tort law principles discussed by Osceola are irrelevant here for two reasons. First, the applicable standards here are not State tort doctrines, but, rather, federal participation requirements, and the two are not necessarily the same. Second, the cited principles and cases are inapposite in any case. Despite the attention Osceola focused on it at the hearing, the deficiency finding here does not depend on the unforeseen failure of the alarm system. It was not disputed that Osceola conducted regular tests of its alarm system and that the staff were unaware of the flaw in the mat system that was discovered during the investigation of R. 10's elopement. Had the facility been required merely to provide an assistive device to prevent accidental elopement, the unforeseeable failure of an otherwise appropriate device might not establish a deficiency.

Osceola similarly errs in its argument that "[t]he threshold issue is whether the use of the alarm system was a reasonable assistance device for the facility to use . . . ." P. Br. at 11. HCFA did not argue and I do not find that the alarm system used was inappropriate or that Osceola should not have employed it in an effort to prevent elopements generally. Nor is there any contention that the alarm system was improper in R. 10's particular case. Again, were the only requirement to use a reasonable assistive device, the case might stand differently.

The regulation requires more, however. The facility is required to provide both "assistive devices" and "adequate supervision" to prevent accidents. What supervision is adequate depends on what kind of measures would be calculated to prevent potential accidents from occurring given the known risks.

The Board has held that "while the regulations do not make facilities unconditional guarantors of favorable outcomes, the quality of care provisions do impose an affirmative duty to provide services (in this case, supervision and devices to prevent accidents) designed to achieve those outcomes to the highest practicable degree." Woodstock Care Center, DAB No. 1726, at 25 (2000). This approach is consistent with the goals of federal law and regulation in moving from a compliance focus on the capacities available in facilities to an emphasis on actual facility performance in meeting the needs of residents for safe and high quality care, while leaving the facilities considerable flexibility in selecting appropriate and effective means of achieving those outcomes. See Omnibus Budget Reconciliation Act of 1987, Pub. L. 100-203; 54 Fed. Reg. 5,316 (1989). In addressing the scope of the duty imposed, the Board considered whether the facility had notice of or should reasonably have anticipated the risk of the kind of events that occurred and whether any reasonable means were available to prevent them without violating the residents' rights. DAB No. 1726, at 26-27. I therefore discuss next what Osceola knew about the risk that R. 10 might elope and suffer injury, and what it might practicably have done to prevent it.

B. The facility was aware that R. 10 was at very high risk for elopement and that an elopement could present serious danger for her.

In order to understand the information known or available to Osceola in assessing R. 10's supervisory needs, I review here the history of her stay at the facility. Most of the facts in this regard are undisputed or derived from the facility's own records. Where I cite to the transcript at the hearing, I have concluded that testimony of the witness cited was the most credible and persuasive information on that point.

R. 10 was admitted on February 5, 1998. HCFA Ex. 4, at 17. She was 81 years old and suffered from dementia and Alzheimer's disease. Id. at 17 and 33. Her vision was impaired by macular degeneration. Id. She was assessed as moderately independent with some difficulty in new situations. Id. at 31. The first day she was tearful, but, nevertheless, seemed to be adjusting well, and the nurse's notes reflect a plan to continue to monitor her progress. Id. at 17.

The next day, however, R. 10 first voiced a desire to leave the facility and stated that she did not understand why she was there. Id. At that point, the facility placed a Wanderguard ankle bracelet on her. Id. The ankle bracelet contained a radio transmitter which would trigger an alarm if she were to open the front door of the facility at which a sensor-equipped mat made by Accutech was located. Tr. at 39-40 (Berry). The facility had other exits but they would sound an alarm whenever opened regardless of whether a resident wore a bracelet. That evening, R. 10 asked to have the Wanderguard removed, stating that "she is leaving tomorrow." HCFA Ex. 4, at 17. On R. 10's third day in the facility, the staff called R. 10's family about her increased "confusion and agitation." Id. at 18. At bedtime, R. 10 was observed without her bracelet and did not wish to discuss where the Wanderguard bracelet was. Id. at 19. The nurse's notes state that "close monitoring will cont. [sic] until another Wanderguard can be placed on her for her own safety." Id. Other notations during these early days reflect that R. 10 was frequently friendly, cooperative in manner, and sociable with staff and other residents, even though at times she became confused and upset about why she was staying in the facility. Id. at 17-19.

I infer from these events that by R. 10's third day in the facility Osceola's staff had or should have arrived at the following observations and conclusions concerning R. 10:

• She was in an adjustment period.
• She would not be safe if she left the facility unsupervised.
• She was confused about why she was in the facility and was motivated to leave.
• She was cognitively impaired to some degree, particularly when in unfamiliar settings.
• She was an elopement risk requiring use of a special alarm system.
• She could evidently remove the alarm bracelet.
• She needed close monitoring.
  

However, the events at issue in this case took place on March 9, 1998, just over a month later, so it is important to see whether the intervening weeks could reasonably have led Osceola to believe that such close supervision was no longer needed. I summarize next the relevant events of the intervening period, as recorded in the nurse's notes.

Four days went by after R. 10 removed the alarm bracelet during which notations were made during most (but not all) shifts reflecting that R. 10 made no elopement attempts and did not verbalize any intent to leave. On February 12^th, R. 10 exited the facility without the knowledge of the staff. She was seen by a nurse walking down the driveway and redirected back inside by the nurse telling her that she needed to wear a jacket because the weather was cold. HCFA Ex. 4, at 20. Only after this episode was a new bracelet placed on R. 10. Over the next 48 hours, the nursing notes reflect four notations that R. 10 had made no further elopement attempts. HCFA Ex. 4, at 20. On February 15^th, three elopement attempts were recorded. Id.

On February 21^st, R. 10 attempted to elope through another exit, which alarmed whenever opened, and was retrieved by a nurse who found her carrying items from her room and indicating that she believed her car was in the parking lot. Id. The nurse's notes record that no elopement attempts occurred during the next three shifts. Id. However, the nurse recorded the following morning that R. 10 had laid out her clothes and said she expected to be leaving for home that day. Id.

On March 1^st, the following entry appears:

300 exit door alarm sounded. Upon inspection, CNA P. Flowers saw this Resident walking towards the road. CNA escorted this Resident back into facility safely. Resident had attempted to leave several times on 2-28-98 by walking out front lobby door. Alarm also sounded when this Resident walked by door. Will continue to monitor Resident closely.

HCFA Ex. 4, at 21. No entry was made on February 28^th concerning the "several" elopement attempts on that date. On the evening of March 2^nd, nurse's notes indicated that R. 10 had attempted to elope twice during that shift and that she remained in a state of confusion. Id. At 9:30 a.m. on March 3^rd, the nurse reported: "Elopement attempts x3 so far today. Exit door alarm alerted staff [and] returned safely." Id. The next entry at 9:50 p.m. on March 4^th records yet another elopement attempt. Id. at 22.

In addition to these recorded elopement attempts, the nursing notes and assessments of R. 10 throughout her stay reflect a frequent recurrence of confusion about what she was doing in the facility and periods of anger and distress. See id., at 47, 52-53. R. 10 had worked at the same facility during an earlier time in her life and frequently believed she was at the facility to work rather than to reside. Id. at 53.

I infer from these events and reports that Osceola's staff had or should have arrived at the following additional observations and conclusions as of March 5^th concerning R. 10:

• She had still not adjusted to her placement in the facility.
• She could not be relied on to dress appropriately or assess her surroundings safely if she left the facility unsupervised.
• She continued to be recurrently confused about why she was in the facility and to want intermittently to leave.
• She was capable of multiple elopement attempts with intervening periods without attempts and did not follow a predictable pattern.
  

Contrary to the implication in Osceola's brief, I do not find it reasonable for Osceola to conclude that the need for monitoring had receded by March 9^th even though no attempted elopements occurred on March 5^th through 8^th. Cf. P. Br. at 13. While the resident was recorded as saying that she had many friends at the facility on March 5^th, the nurse noted that they would continue to "monitor." HCFA Ex. 4, at 22.

I find additional evidence in the facility record that Osceola had indeed recognized the high risk of elopement by R. 10 and the need for carefully monitoring her whereabouts in addition to using the alarm system. I find that Osceola reassessed R. 10's social adjustment on February 18^th and recorded that she is "constantly attempting to leave facility" Id. at 53. Her resident assessment of February 20, 1998 identified the risk of elopement, which they were seeking to decrease by use of the Wanderguard, by redirection, and by planning to "monitor whereabouts." Id. at 49. The resident review of February 26^th , updated March 3, 1998, noted her confusion and anxiety, her repeated packing of her belongings and occasional elopement attempts, and repeated the plan, among other steps, to "monitor [her] whereabouts and redirect as needed." Id. at 10-13; see also id. at 56. In the last comprehensive care plan in the record for R. 10, dated February 26, 1998, Osceola set the goal for dealing with her Alzheimer's disease as follows: "Whereabouts will be known to staff time [sic] as demonstrated by no incident reports due to leaving facility." Id. at 13.⁽¹⁾

I conclude that Osceola had notice that R. 10 was at high risk for elopement which continued through March 9^th, and that Osceola also knew that R. 10 required active monitoring to ensure that she did not meet with an accident.

A good deal of hearing time was spent examining how the alarm mat system was malfunctioning or whether the mat was properly sized or placed. See, e.g., Tr. at 39-45, 57-80. Ultimately, however, these questions were peripheral to the issue of Osceola's notice of and responsibility to address R. 10's risk of elopement. The surveyors discovered during their investigation that it was possible to defeat the system by standing on the mat for 30 seconds before opening the door or by approaching the mat at a particular angle. Tr. at 64-80 (Berry). It was never determined how R. 10 was actually able to exit the front door wearing a bracelet that later proved functional without setting off an alarm. See Tr. at 46 (Berry). That she did so was evident, because footsteps led from the front entry to the location where she lay in the snow, and staff interviews confirmed that no alarm was heard. Tr. at 49-50 (Berry).

It was uncontradicted that the facility had performed weekly tests of the mat and bracelets, according to manufacturer's instructions, and HCFA conceded that those tests would not necessarily disclose the problems discovered. See Tr. at 94, 217, 235; P. Ex. 1, at 1-8; HCFA Ex. 1, at 5. HCFA did present evidence, however, that another resident wearing a Wanderguard bracelet had exited through the front door on another occasion without setting off an alarm. Tr. at 52-53 (Berry). The facility administrator told a surveyor that the bracelet involved was determined to be defective and that no further incidents occurred involving that resident once the bracelet was replaced. Id.; HCFA Ex. 4, at 84; P. Ex. 5, at 3-4. Nevertheless, the episode establishes that Osceola's administration knew that alarm bracelets could fail unexpectedly despite routine testing.

I infer that Osceola thus knew or should have known that the alarm system alone could not be trusted to prevent elopements by residents at risk. Osceola argued that this history was irrelevant since R. 10's bracelet was still on her body and still functional after she was found. P. Br. at 6. Osceola has missed the point. Just as the fact of elopement alone does not prove inadequate supervision, the fact that elopement occurred by an unforeseen means does not justify failing to provide supervision adequate to prevent its occurrence by a foreseeable means. It was foreseeable based on Osceola's knowledge that the alarm system would not suffice to prevent elopement.

How R. 10 bypassed the alarm system makes no difference. What matters is that practicable measures were available to reduce the risk of her elopement through close supervision in light of her known proclivity to elope and potential to do so despite the alarm system. Had her whereabouts been checked frequently, it is reasonable to presume that the chances would have been much greater either that staff might have observed her attempting to leave or, at the least, her absence would have been noted and a search initiated more promptly. Hence, regardless of how the accident took place, both the two previous episodes involving bypassing of the alarm system (by R. 10 and another resident) strongly reinforced the importance of having a plan to supervise her movements.

I conclude that Osceola had ample notice that R. 10 required close monitoring of her whereabouts for her safety and that Osceola's reliance on the alarm system alone to give warning of any actual elopement was inadequate in the situation.

C. The surrounding environment clearly raised serious and foreseeable dangers should an elopement occur.

R. 10's death was caused by hypothermia due to exposure. HCFA Ex. 4, at 7-8. The weather was recorded in the surveyor notes, after the surveyor's consultation with a State climatologist. The temperature during the period R. 10 was outside was 16 degrees with wind gusts varying from 21 - 26 miles per hour and wind chill temperatures at -17 to -20 degrees. Id. at 70. The ground was snow-covered after several recent snowstorms. Tr. at 38 (Berry); HCFA Ex. 4, at 70.

I have already found that R. 10's mental condition was impaired by Alzheimer's disease and other dementia processes and that her vision was compromised by macular degeneration. These clinical conditions plainly increased the danger that she would be unable to identify, assess, and respond to dangerous conditions rationally. In addition, the earlier incident in which R. 10 was observed outside the building in mid-winter without a jacket confirms her inability to make appropriate judgments. The record also contains uncontradicted evidence that a person of her age ran an increased risk of hypothermia due to decreased circulation and diminished capacity to sense cold. Tr. at 54 (Berry).

I also note that Mr. Berry reported that the facility was located at the edge of town on a road with a 50 mile per hour speed limit. Tr. at 38. This presented additional potential hazards to R. 10, given her combination of mobility and cognitive and visual impairments.

I conclude that the danger presented by a failure to use adequate means to forestall a successful elopement by R. 10 was predictably severe, even lethal.

D. Osceola failed to take reasonable steps to ensure that R. 10 was adequately supervised on the day she eloped and died.

HCFA presented the nurse's notes from March 9^th and information from the surveyors' interviews with Osceola staff present on that date to support the deficiency finding of inadequate supervision. No interaction at all with R. 10 was recorded in the day's nurse's notes. A physician progress note indicates that she was seen at some time that day (the box to record time was left blank) and that she was "confused" but voiced "no complaints." HCFA Ex. 4, at 51.

Despite interviewing the staff members on duty that day, the surveyors could not identify any staff member who knew R. 10's whereabouts from approximately 3 p.m. until 5:15 p.m. on May 9^th. An aide, in the course of her routine duties, recalled observing R. 10 several times during the morning and seeing R. 10 in passing standing in her bathroom at about 2:30 or 3 p.m. that day. HCFA Ex. 6, at 12. A licensed practical nurse, Mr. Scott Burkeybile, reported in an interview with the surveyors that he noted at about 3:45 p.m. that R. 10 was not in her room. Id. at 11. He had not observed R. 10 since he came on duty at 3 p.m., but her roommate told him that R. 10 was "out running around as usual." Id. He reported taking no other steps to locate her until 5 p.m. when he became "anxious that he had not seen her at all." Id. He then approached the registered nurse, Sheryl Robins, who had been on duty since noon and who reported in her interview that she had not seen R. 10 all day. At that point, a search was begun.

R. 10 was found by Rene Meister, another licensed practical nurse on duty that day who had not previously seen R. 10 at all that day. Id. at 9. She described R. 10 as lying on her side in the snow "almost like she laid herself down," her eyes open and her body "cold and stiff" with no discernable pulse. Id. The consensus of the interviews was that no alarm sounded and that no one else remembered seeing R. 10 that day before she was found. Id. at 6-18. HCFA also established that R. 10 was unattended in the snow long enough to have arrived at a church located several hundred feet from the door through which she exited and to have suffered terminal exposure.

Absent effective rebuttal, I can reasonably infer from the absence of documentation of R. 10's activities or whereabouts on the afternoon of March 9, 1998, from the reports of the staff on duty that day in their interviews, and from the fact of her elopement and exposure for a time sufficient to cause her death, that R. 10 was inadequately supervised that day. Therefore, I turn to any evidence offered by Osceola that might tend to rebut this inference. I find none.

The most striking aspect of Osceola's presentation at the hearing was its choice not to call a single witness responsible for or involved in the direct care of R. 10, or other at risk residents, during the days at issue. Not one of the persons whose interviews were reported by the surveyors and discussed above appeared at the hearing on behalf of Osceola. Only one witness presented by Osceola, Mr. Anderson, was an employee there. Two, Mr. Mitchell and Mr. Jones, were employees of Care Initiatives (Osceola's parent) who had responsibility for safety and environmental issues respectively in its 43 different facilities and who testified almost entirely about the alarm system at Osceola. Tr. at 262-86. Ms. Munson, the remaining Osceola witness, was a nurse-consultant employed by Care Initiatives, who testified concerning her after-the-fact investigation of R. 10's elopement and death and about her understanding of resident monitoring and documentation practices generally. Tr. at 287-317.

Yet, Mr. Burkeybile, Ms. Robins, and Ms. Weaver (all staff members who had roles in caring for R. 10 and two of whom were on duty on March 9, 1998) were on Osceola's witness list. Osceola identified two as current employees and sought a subpoena for the third. In weighing the information from the surveyors' interview notes about the supervision which R. 10 received on March 9, 1998, I take Osceola's failure to present these witnesses (as well as its failure to list or present Ms. Meister, the only staff member reporting any interaction with R. 10 that day) for cross-examination into account. These interviewees had reason to take seriously the information they were providing, since they were aware that the surveyors were investigating a resident's death while in their care. If anything, they had incentive to maximize rather than diminish their reports of supervision and interaction with the resident. In addition, the interviews took place within hours, if not a matter of a day or two, of the incident while the events were still fresh in their minds.

I therefore find reliable the hearsay statements of staff members who reported not seeing R. 10 that day and accept the statements as credible, at least insofar as they contained admissions against the interests of their employer. I conclude that it is most likely that only Ms. Meister recalled encountering R. 10 at all, and she did so, at most, in the course of routine care and lunch service, and that the latest she saw R. 10 was incidentally in passing R. 10's room around 2:30 or 3:00 p.m. at the latest. I find that neither Mr. Burkeybile nor Ms. Robins interacted with R. 10 on March 9^th and that neither of them made any effort to locate R. 10 that afternoon, other than Mr. Burkeybile's 3:45 p.m. inquiry to her roommate.

The facility administrator, Mr. Anderson, was not on site at the time of the elopement. Tr. at 236. He reported that none of the staff whom he questioned knew how R. 10 had gotten out, but that he thereafter initiated 15-minute checks of at-risk residents and staff observation of exit doors. Tr. at 237, 239. He did not offer any additional information about interactions or supervision or monitoring efforts by staff on March 9^th, which further confirms my conclusion that the interviews represented the nature of the supervision that, at most, R. 10 received that day. As regards R. 10, Mr. Anderson testified that the resident was "very sociable" and spent most of her time visiting others rather than in her room, so that her absence from her room would not be alarming in itself. Tr. at 249. The Director of Nursing, Linda Weaver, when asked in her interview why the staff had not looked for R. 10 earlier, offered the explanation that R. 10 had once worked at the facility (which sometimes made her anxious and confused about her status as resident) and that she was indeed often "out and about" socializing or "looking for her purse." HCFA Ex. 6, at 6.

While Osceola appeared to conclude that this information demonstrated that Mr. Burkeybile was reasonable in not instituting a search when he first noted R. 10's absence from her room, I find that the evidence supports another inference. If the whereabouts of this resident were to be monitored due to assessed high risk for elopement and she was known to spend most of her time visiting around the facility, I infer that checking her room once in an afternoon without taking other steps was not a reasonable method of monitoring her whereabouts. No individual was identified by Osceola as having the assigned responsibility to keep track of R. 10's wanderings that day. The fact that R. 10's socializing was interspersed with anxiety, confusion, and, apparently, an intermittent belief that she was at work and needed to find her purse and go home, suggests to me that some more active and regular check on her whereabouts and state of mind was essential.

Osceola relied heavily on general testimony that resident care includes such daily services and oversight as meals and snacks, administration of medications, dressing and toileting, nursing rounds, and various resident activities. P. Br. at 12. It was not contested that such care involves contact with and, in some sense, supervision of the residents. Tr. at 211-12 (Dittmer). What I find disturbing, however, is that no staff person recalled a single such interaction with R. 10 that afternoon. No nurse or aide had brought her a snack, seen her during rounds, toileted her, invited or taken her to or from an activity, given her medication or provided any other form of routine care after 1 p.m. that day. I am not concerned merely that routine interactions or other monitoring practices were not charted or documented that day, but that I have absolutely no direct evidence before me that they occurred at all during approximately a four-hour span for a resident assessed as at risk of elopement and in need of monitoring.

2. The failure to provide adequate supervision reflected a failure to administer the facility effectively to ensure such supervision.

I find that Osceola failed to implement policies and practices that would have ensured compliance with the requirement to provide adequate supervision to prevent accidents through elopements. Osceola had a policy in place addressing missing residents which stated: "Personnel who have residents under their care are responsible for knowing the location of those residents at all times." HCFA Ex. 5, at 4 (emphasis added).

Despite this written policy, none of the staff members responsible for R. 10's care could account for her whereabouts from at least 2:30 or 3:00 p.m. until she was found at 5:15 p.m. The explanation offered by the facility was that the resident was sociable and often visiting elsewhere in the facility so that staff members were not concerned about her absence from her room or able to track her location. HCFA Ex. 1, at 4. This explanation suggests that a resident is expected to remain sedentary in order to facilitate tracking her location, which hardly promotes involvement in socializing and other activities. Under its own policy, Osceola's administration undertook to know the whereabouts of its residents within the facility to forestall situations where residents go missing. Thus, its own policies contemplate that staff members should do more than just shrug their shoulders when a resident is not in her room.

After the unfortunate incident in question, the facility instituted a new policy requiring documented checks every 15 minutes on all residents wearing Wanderguard alarms. HCFA Ex. 1, at 4; HCFA Ex. 5, at 9.⁽²⁾ The facility also began placing staff to observe the front entry door visually. HCFA Ex. 4, at 75. IDIA determined that the immediate jeopardy was corrected prior to the completion of its survey on March 13^th. HCFA Ex. 8, at 4.

3. The conditions under which inadequate supervision permitted the elopement to occur presented risk of death and bodily harm sufficient to establish immediate jeopardy.

4. HCFA's determination of the level of non-compliance was not clearly erroneous.

An immediate jeopardy level deficiency 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.

42 C.F.R. § 488.301. A resident need not actually be harmed or die in order for there to be immediate jeopardy. Any situation which poses a likelihood for causing serious injury, harm, impairment, or death to a resident is sufficient to constitute immediate jeopardy even if actual harm has not yet occurred. Id.

The regulations require that deference be paid to HCFA in determining when a particular deficiency has resulted in immediate jeopardy. If a facility fails to comply substantially with a participation requirement, and HCFA determines that the level of noncompliance is immediate jeopardy, then HCFA's determination as to the level of noncompliance must be sustained unless it is established to be clearly erroneous. 42 C.F.R. § 498.60(c)(2). I find that the same conditions already discussed, which should have alerted Osceola to the need for close monitoring of a new resident with a strong proclivity to elope and mental confusion making unsupervised departure risky, are also sufficient to establish that this absence of adequate supervision presented an immediate jeopardy of elopement and resultant accidents. In addition, the weather conditions and R. 10's known inability to dress appropriately for those conditions, along with the available information about the local situation also discussed above, heightened the predictable severity of the consequences.

The proof of immediate jeopardy lies not in the simple fact that R. 10 died, but in the fact that Osceola's failure to supervise her adequately to avert the risk of elopement under all the known circumstances placed R. 10 in a position that was extremely dangerous. In other words, even had she been fortunate enough to have been found without suffering serious injury, she would still have been placed in immediate jeopardy of serious harm to her health and safety. I therefore conclude that HCFA was not clearly erroneous in determining that immediate jeopardy was present.

5. Osceola failed to prove that it was providing adequate supervision on the three days preceding the elopement.

6. HCFA had a basis to impose a CMP for all four days on which Osceola failed to show that it was in substantial compliance with participation requirements.

Osceola argued that, in extending the period of non-compliance to include the three days preceding the elopement, HCFA was faulting it not for inadequate supervision but for inadequate documentation of supervision. Osceola contended that no specific documentation requirement existed, that adequate supervision should be inferred from the absence of entries to the contrary in the nurse's notes, that supervision occurred as part of daily routine activities that would not have been recorded because the facility's practice was to chart only exceptions to the routine, and that HCFA had not proved that no supervision was provided during the days in question.

I conclude that HCFA has set out a prima facie case that R. 10 was not adequately supervised during the last four days of her life. The only entry in the nurse's notes for R. 10 during the period from March 6^th through March 9^th was made at 6 a.m. on March 6^th and reads as follows: "Has remained in room all shift." HCFA Ex. 4, at 22. The preceding day, the morning nurse stated that R. 10 had not made any elopement attempts since the evening before and that R. 10 had not talked about going home and had talked about her many friends at the facility. Id. It concluded: "Will monitor." At 9 p.m., the nurse reported no elopement attempts during the past eight-hour shift. Id. The record is then completely silent about R. 10's adjustment and activities or any monitoring of her with the one exception quoted. I do not conclude from this that Osceola's staff had no contact at all with R. 10 during those days. I do conclude that, on the face of her nursing records, no special monitoring was provided in spite of the recent history of roughly 15 elopement attempts in 27 days and of the notation on March 5^th that she would be monitored.

I turn next to whether Osceola presented evidence sufficient to rebut this prima facie case and to demonstrate by the preponderance of the evidence that it was in compliance during one or more of these days with the requirement to provide R. 10 with supervision adequate to prevent accidents. I conclude that Osceola failed to present such evidence.

The nursing records for R. 10 for the three days before the day of her death are undeniably virtually blank. Osceola argued that the absence of notations actually reflected their policy of "charting by exception," which was explained at the hearing as essentially recording only the activities of or incidents in the care of a resident that vary from established routine. Tr. at 115 (Berry). Osceola argued that HCFA was improperly attacking it for employing an appropriate and widespread approach to documentation in the absence of any federal requirement to document supervision. P. Br. at 11-13. On the contrary, according to Osceola, the absence of notation for these days should essentially be treated as evidence that all routines were followed adequately and without incident. Id.

The testimony of HCFA's witnesses narrowed the dispute by making clear that HCFA did not in fact condemn the practice of charting by exception in general and did not assert that R. 10 received no supervision at all during the daily routines of the critical days. See, e.g., Tr. at 115-26 (Berry), 139-40 (Kluza). I agree with HCFA's witnesses that the daily routine interactions of staff with a resident in bathing, dressing, feeding and so on are supervisory in at least some sense. I further find that the record does not show that R. 10 was left utterly to her own devices for the entire four day period without such routine care. The question before me, however, is not whether she received any supervision, but whether she received adequate supervision calculated to meet her needs. It is clear to me that, on the record as a whole, in no sense did R. 10 receive such supervision, certainly not during the days at issue.

I find that the facility's records do not support its claim that the absence of notations during the four days at issue amounted to uncontroverted evidence of daily oversight and care of R. 10, on the theory that if anything were amiss it would have been recorded. Cf. P. Br. at 12; P. Reply Br. at 6-7. I reach this conclusion not because such an inference could never be established in an appropriate case, but because I find Osceola failed to establish a sufficient predicate to make such a presumption here.

First, at best, the absence of notations in a charting-by-exception system would denote the continuation of established routines and protocols without deviations or incidents. I do not find any demonstration by Osceola that an adequate plan of supervision of R. 10 via monitoring of her whereabouts sufficiently to prevent accidents through elopement was ever established or made routine in practice. Therefore, I have no factual basis to infer from the silence that a particular supervisory regime was followed on those days.

Second, the presumption Osceola seeks would be proper only if the facility had established the premise that deviations from the norm or significant incidents were reliably and promptly noted. Osceola's nurse's notes on their face do not inspire such confidence. One telling example may be found by observing that the entry noted in R. 10's record for March 1^st makes passing mention that R. 10 had attempted elopement by leaving through the front door several times on February 28^th as well, yet no notation of any of these attempts was made on February 28^th. Furthermore, the incident reported to the surveyors, in which R. 1 eloped while wearing a defective bracelet, was evidently not recorded in that resident's nurse's notes either. See Tr. at 52-53; HCFA Ex. 6, at 15, 17; P. Ex. 5. Osceola argued that HCFA's witnesses had conceded the accuracy of its nurse's notes, but it relied only on the testimony of Ms. Dittmer. P. Br. at 13. She stated that she had "no indication" that Osceola's documentation was "accurate or not accurate" and agreed that the accuracy and extent of record-keeping was not identified as a problem in the list of factors considered by IDIA in recommending sanctions. Tr. at 204; HCFA Ex. 3, at 3-4. This testimony does not establish the accuracy or reliability of Osceola's nurse's notes. I am able to review the face of the records myself and draw inferences from the inconsistencies I find there. Also, I do not find Ms. Dittmer's testimony to constitute a blanket endorsement of the reliability of the notes. A review of the factor form shows an entry after the item for accuracy and extent of records reading: "Nursing notes. Product information." Ms. Dittmer indicated that this entry did not reflect any problems with the accuracy of the facility's documentation, but did not indicate whether any problems were noted in the extent or completeness of the records. This item, in any case, specifically relates to a State requirement and not a federal one, and I have no information as to what the State standard being applied there may have required as to record-keeping. HCFA Ex. 3, at 4. Furthermore, Ms. Dittmer indicated that, as a program coordinator, she directed the assignment of surveyors and reviewed the determinations, but did not visit Osceola. Tr. at 176-84. She would not have reviewed other facility documentation beyond that on which the surveyors based a deficiency determination. Tr. at 214. I am not persuaded that Osceola's nurse's notes for R. 10 were consistently complete and reliable enough to support a presumption that the absence of any entry should be presumed to reflect the presence of any particular degree of supervision. That is, I do not conclude that silence on a particular day meant no supervision or interaction at all, but I do conclude that silence does not support a finding of adequate supervision.

Third, uncontradicted testimony by one of the nurse surveyors demonstrated that charting by exception requires a period of acclimation for a new resident and the establishment of a base line expectation as to the resident's daily routines, activities and needs. Tr. at 139-40 (Kluza). The repeated occurrence of elopement attempts, as well as the frequent notations of verbalizations by R. 10 of confusion about her placement in the facility and of her desire and intention to leave, raise substantial doubt that the resident had yet adjusted. See Tr. at 168 (Kluza). In fact, Ms. Weaver (the DON) told the surveyors that

R. 10 was in "an adjustment period" and that she was receiving medication to help with her "anxiety during transition period." HCFA Ex. 6, at 6.

Fourth, the only routine of monitoring which could, in any case, be derived from a review of the nurse's notes is a general pattern of having nurses record whether another elopement attempt was made during their respective shifts for approximately 24-48 hours after each elopement. None of these entries specify what checks or monitoring were undertaken to assure the accuracy of this, but, presumably, it was based at least on R. 10's presence at the time of the entry and the absence of any alarm during the shift. The notes themselves make abundantly clear that this pattern of attending to whether R. 10 eloped for several shifts after an attempt was not adequate, since over and over again R. 10 returned to verbalizing an intent to leave and making efforts to exit the building despite not having been reported to have done so for more than two days. Since, to the extent that any routine was established by this record for monitoring of R. 10 that might have been presumed to continue via charting only exceptions from it, Osceola manifestly knew that it was not adequate to prevent repeated elopement attempts.

I conclude that the period of substantial noncompliance was at least from March 6, 1998 through and including March 9.

7. A CMP of $10,000 a day was reasonable in light of all the circumstances.

The amount per day of the CMP imposed by HCFA is at the top of the available range. IDIA recommended this maximum daily amount to HCFA. Among the factors IDIA noted in regard to its recommendation of that amount were the facility's failure to follow its own policy to monitor whereabouts of residents at all times, the immediate jeopardy rating of the deficiencies, and the severity of the harm since a death was involved. HCFA Ex. 2, at 5; HCFA Ex. 3, at 3.

In determining what amount of CMP within that range is reasonable, I may consider only the same regulatory factors that HCFA may consider in setting a CMP amount. 42 C.F.R. §§ 488.404; 488.438(e)(3); and 488.438(f). Among these factors are: (1) the facility's history of noncompliance, including repeated deficiencies; (2) its financial condition; (3) its culpability for the deficiencies; (4) the relation a given deficiency may have to other deficiencies; and, (5) the facility's prior history of noncompliance. I have considered all these regulatory factors in this case. Several had no bearing here. Nothing in the facility's history of noncompliance raises any concerns other than those apparent from the events at issue.

In regard to the three days before March 9^th, I conclude that the same CMP amount is appropriate even though the actual harm had not yet occurred. By its failure to demonstrate any effort to monitor R. 10's whereabouts on those days, Osceola exposed her to precisely the same danger from which she died on the fourth day.

Both parties cited to another case in which the ALJ found a $10,000 per day CMP to be reasonable in support of their respective arguments about whether that amount is reasonable in the circumstances present in this case. I find that the reasoning there is analogous to mine here in concluding that a maximum CMP is warranted and supports HCFA's rather than Osceola's position. In Wellington Specialty Care & Rehabilitation Center, DAB CR548 (1998), a resident strangled in the side rails of her bed. The ALJ in that case found that the facility had specific notice of the hazards of side rails used without protective padding for patients with dementia and restlessness. Further, the facility staff had in fact assessed the resident as at risk and needing padding, but no padding was actually installed, even after an incident in which the resident became wedged in the side rails. The ALJ rejected arguments that the overall quality of care for the resident was adequate as irrelevant to the determination that the failure to pad her side rails in the face of notice of predictable and severe hazards from such neglect was egregious. I similarly find that Osceola's failure to implement any system for monitoring R. 10's whereabouts, in the face of its own staff's assessment of her needs and notice of her vulnerability, is egregious. The ALJ there focused on two factors to find the high CMP appropriate: the seriousness of the deficiency with fatal consequences for one resident and the high degree of culpability for that deficiency. I have found the same two factors to be present at a similarly egregious level here. In the present case, as in Wellington, the prior incidents, including those involving the same resident, should have alerted the facility that the measures on which it was relying were inadequate.

Osceola nevertheless argued that the facts in Wellington from the present case were as different "as night [is] from day," so that by contrast the present case does not justify so severe a penalty. P. Br. at 5. Specifically, Osceola argued that Wellington had actual knowledge that the side rails were dangerous but took no action to pad them, whereas Osceola had no notice that its alarm system was defective.

The core of the factual scenario in Wellington is as follows: The side rails used by Wellington were not shown to be defective, but reliance on their use without additional protective measures was shown to be predictably hazardous for residents of precisely the type ultimately injured; they were used in a manner inconsistent with the staff's assessments and facility policy; and the situation was not corrected despite a prior incident with that resident that should have highlighted the danger. In the instant case, the cause of the deficiency was not that the alarm system turned out to have a vulnerability, but that Osceola's reliance on the bracelet alarms alone was predictably hazardous for residents with the characteristics demonstrated by R. 10, was contrary to staff assessments and written facility policy, and continued despite the warning afforded by incidents involving R. 10 and one other resident. I find the parallels between these cases more compelling than the circumstantial differences.

I conclude that a CMP of $10,000 per day for four days is reasonable in this case.

Conclusion

In summary, Osceola failed to prove by the preponderance of the evidence that it was in compliance with either of the cited requirements from March 6, 1998 through and including March 9, 1998, and further failed to show any clear error in HCFA's assessment that the situation constituted immediate jeopardy to resident health and safety. HCFA has a basis to impose a CMP for four days and the amount of $10,000 per day is reasonable under all the relevant circumstances.

Alfonso J. Montano

Administrative Law Judge

1. Osceola argued that it is "crucial" to its case that no deficiencies were cited concerning its compliance with care plan requirements in regard to its written care plan for R. 10, which included use of the alarm bracelet and directions to monitor her whereabouts. P. Br. at 11. Osceola couches the deficiency with which it is charged as a failure to "document" supervision, where the regulations do not mandate particular documentation. As discussed in the text, the failure here is not of mere documentation, but, rather, of adequate monitoring of R. 10's whereabouts to keep her safe. There is thus no inconsistency in HCFA finding the care plan acceptable and its implementation deficient.

2. The surveyors identified eight other residents wearing alarm bracelets, as well as one resident assessed as at risk for elopement but not wearing a bracelet, out of a census of 80 residents. HCFA Ex. 4, at 83.