Department of Health and Human Services DEPARTMENTAL APPEALS BOARD Civil Remedies Division |
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IN THE CASE OF | |
Osceola Nursing & Rehabilitation Care Center, |
DATE: May 21, 2001 |
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Health Care Financing Administration
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Docket No.C-00-069
Decision No. CR775 |
DECISION | |
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 -
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 --
42 C.F.R. � 483.25. The specific requirement with respect to which Osceola was alleged to be deficient reads as follows:
* * *
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:
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.
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.
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:
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 12th, 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 15th, three
elopement attempts were recorded. Id. On February 21st, 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 1st, the following entry appears:
HCFA Ex. 4, at 21. No entry was made on February 28th
concerning the "several" elopement attempts on that date. On the evening
of March 2nd, 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 3rd, 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 4th
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 5th concerning R. 10:
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 9th even though no attempted elopements
occurred on March 5th through 8th. Cf. P.
Br. at 13. While the resident was recorded as saying that she had many
friends at the facility on March 5th, 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 18th 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
26th , 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 9th, 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.
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.
HCFA presented the nurse's notes from March 9th
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 9th. 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 9th 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
9th, 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. I find that Osceola has not shown by the preponderance of the evidence that it provided supervision to R. 10 on March 9, 1998 adequate to prevent accidents.
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 13th. HCFA Ex. 8, at 4. I conclude that these policies were reasonable means calculated to ensure the prevention of accidents attendant on elopements by cognitively impaired residents inclined to exit the facility unattended. The fact that these measures could be adopted promptly demonstrates that they were not impracticable. Indeed, they were consistent with the written policy of monitoring the whereabouts of residents with a proclivity to wander or go missing and had they been implemented prior to March 9th they might have prevented R. 10's death.Peggy Munson, a nurse consultant for the parent corporation, testified that the written care plan for monitoring R. 10 should not be interpreted to mean that staff must know her whereabouts at every moment. Tr. at 307-08. As I have noted, Ms. Munson was not employed at Osceola and reported no contact with R. 10, so her testimony was as to generalized expectations about what supervision might be provided to a resident rather than personal knowledge as to what supervision was provided to R. 10. In any case, I need not decide whether the care plan or the written policy means that at-risk residents generally, or R. 10 in particular, should have been observed continuously, checked at 15-minute intervals, or checked at some other frequency. What I find is that the policy and care plan intended affirmative and systematic ascertainment of the location of each at-risk resident by a responsible staff person on some regular and frequent basis. That is to say, some engagement beyond the routine care interactions provided to residents generally, such as were described by Ms. Munson as "supervision," was implied by the plan to monitor R. 10's whereabouts. Tr. at 295-307. No such engagement is documented, but, beyond that, no evidence (such as testimony by caregivers) was proffered that such efforts, whether or not individually recorded in notes, ever actually took place. Osceola presented no evidence whatsoever of any responsible staff person having undertaken any conscious plan of regularly checking her whereabouts on any schedule. Yet, R. 10's situation, as explained above, evidenced the need for such monitoring in her case, even were there not such a generally applicable written policy. I conclude that the failure to fully implement the existing policies and to adopt more specific monitoring practices establish that Osceola was indeed deficient in administration in carrying out the requirement for adequate supervision which requires using reasonable and practicable means for preventing foreseeable accidents.
An immediate jeopardy level deficiency is defined as a --
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.
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
6th through March 9th was made at 6 a.m. on March
6th 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
5th 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 1st makes passing mention that R. 10 had attempted
elopement by leaving through the front door several times on February
28th as well, yet no notation of any of these attempts was
made on February 28th. 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.
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 9th,
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. |
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JUDGE | |
Alfonso J. Montano Administrative Law Judge
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FOOTNOTES | |
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. | |