Department of Health and Human Services DEPARTMENTAL APPEALS BOARD Appellate Division |
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IN THE CASE OF | |
Koester Pavilion, |
DATE: October 18, 2000 |
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Health Care Financing Administration.
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Civil Remedies CR650 |
DECISION | |
FINAL DECISION ON REVIEW OF The Health Care Financing Administration (HCFA) appealed the February 29, 2000 decision of Administrative Law Judge (ALJ) Jill S. Clifton concluding that Petitioner, Koester Pavilion (Koester), was in substantial compliance with Medicare participation requirements. Koester Pavilion, DAB CR650 (2000) (ALJ Decision). HCFA had determined that Koester was not in substantial compliance during 50 days from July 9, 1997 through August 28, 1997, and that during the first day of the period the cited conditions posed an immediate jeopardy. Based on these findings, HCFA imposed a civil money penalty (CMP) of $3,050 for the first day and $50 per day thereafter, for a total CMP of $5,550. The ALJ found that Koester was in substantial compliance with each of the regulations for which HCFA cited it during the period at issue, and therefore concluded that HCFA was not authorized to impose any CMP on Koester. For the reasons explained below, we affirm the ALJ Decision in part and reverse it in part. We conclude that HCFA is not authorized to impose the CMP of $3,050 because Koester was in substantial compliance with the participation requirement on which the immediate jeopardy determination was based. We also conclude, however, that HCFA is authorized to impose the $50-per-day CMP for the fifty-day period cited by HCFA because Koester was not in substantial compliance with two remaining participation requirements. Background Koester is a 150-bed skilled nursing facility (SNF) located in Troy, Ohio, and participates in the Medicare program under a provider agreement with the United States Department of Health and Human Services (HHS). Koester is subject to periodic surveys to determine its compliance with the statutory and regulatory requirements of participation imposed on all SNFs. See generally Section 1819 of the Social Security Act; 42 C.F.R. Parts 483, 488, and 489. A survey of Koester was conducted by the Ohio Department of Health (a State survey agency with which HCFA contracted for this purpose) from July 7 - 10, 1997. The surveyors cited three participation requirements with
which Koester was not in substantial compliance. P. Ex. 30.(1)
The most serious finding was under F Tag 323, alleging that Koester violated
a quality of care requirement to provide a "resident environment . . . as
free of accident hazards as possible" and that the violation presented
an immediate jeopardy to resident health and safety. 42 C.F.R. � 483.25(h)(1);
P. Ex. 30, at 31-39. The F Tag 323 citation was based on the surveyors'
observation on July 9th of one male resident we refer to as
Resident (R.) 113. The surveyors questioned whether bed rails were used
properly in conjunction with R. 113's Posey waist restraint. The surveyors also cited Koester under F Tag 324 for failing
to provide adequate supervision or assistive devices to prevent accidents
to which they assigned a level of G (isolated actual harm that is not
immediate jeopardy). 42 C.F.R. � 483.25(h)(2); P. Ex. 30, at 40-41. The
surveyor findings in relation to this tag related to two residents (R.
24 and R. 134) who sustained falls. Finally, Koester was cited under F Tag 314 for failing
to prevent new pressure sores unless clinically unavoidable or to provide
necessary treatment to those who arrived with pressure sores. 42 C.F.R.
� 483.25(c); P. Ex. 30, at 28-31. The surveyors also assigned a level
of G to this tag in relation to their findings about four residents who
suffered from pressure sores (R. 24, R. 44, R. 30, and R. 8). Applicable Legal Provisions For purposes of surveys of facilities like Koester, the regulations define "substantial compliance" as "a level of compliance with the requirements of participation such that any identified deficiencies pose no greater risk to resident health or safety than the potential for causing minimal harm." 42 C.F.R. � 488.301. "Immediate jeopardy" is defined as "a situation in which the provider's noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident." Id. The three participation requirements (two relating to
accidents and one to pressure sores) under which Koester was cited all
fall under the rubric of "quality of care" requirements and share the
same regulatory objective that "[e]ach resident must receive and the facility
must provide the necessary care and services to attain or maintain the
highest practicable physical, mental, and psychosocial well-being, in
accordance with the comprehensive assessment and plan of care." 42 C.F.R.
� 483.25. The specific provisions at issue were the following:
42 C.F.R. �� 483.25(h).
42 C.F.R. � 483.25(c). Before the ALJ, a facility must prove substantial compliance
by the preponderance of the evidence, once HCFA has established a prima
facie case that the facility was not in substantial compliance with one
or more participation requirements. Hillman Rehabilitation Center,
DAB No. 1611 (1997), aff'd sub nom Hillman Rehabilitation
Center v. U.S. Dept. of Health and Human Services, No. 98-3789(GEV),
slip. op. at 25 (D.N.J., May 13, 1999). However, HCFA's determination
that a deficiency constituted immediate jeopardy must be upheld unless
the facility proves that the determination was clearly erroneous. 42 C.F.R.
� 498.60(c)(2); see also Woodstock Care Center, DAB
No. 1726, at 9 (2000). HCFA excepted to the following Findings of Fact and Conclusions
of Law (FFCLs):
ALJ Decision at 4 (citations omitted).(2)
HCFA raised no exception to the first four FFCLs in the ALJ Decision,
and we affirm them without further discussion. ALJ Decision at 3-4. HCFA argued that the ALJ applied the wrong standard in
evaluating the immediate jeopardy deficiency finding. HCFA argued that
the ALJ should have applied the clearly erroneous standard, for the meaning
of which it cited two Supreme Court cases, in evaluating this finding.
HCFA Br. at 3-4. Under that standard properly applied, HCFA argued its
finding of noncompliance at the immediate jeopardy level must be upheld.
Id. at 3-16. HCFA also argued that the ALJ erred as a matter of
law in not giving weight to the expert testimony of the surveyors and
in holding immediate jeopardy exists only where actual harm occurs. Id.
at 11, 13-16. Further, HCFA argued that immediate jeopardy exists when
"a situation is life-threatening . . . a situation that is 'likely' to
cause harm." HCFA Br. at 15. HCFA contended that the facts in this case
met that standard in light of guidance in the manufacturer's instructions
and in FDA alerts about the seriousness of the threat where restraints
are used with side rails. See, e.g., P. Ex. 30, at 80-82. As to the alleged failure to provide adequate supervision or devices to prevent accidents, HCFA argued that the ALJ erred in finding that Koester took all reasonable measures to prevent falls. HCFA Br. at 20. As to the pressure sore deficiency, HCFA argued that the ALJ erred in concluding that the regulation was not violated where the facility promptly treated a newly-developed pressure sore and where the identified problems were isolated rather than constituting a pattern. HCFA Br. at 16. Below, we first discuss the contentions about the immediate
jeopardy deficiency. We then address the parties' arguments concerning
whether Koester failed to take requisite measures to prevent falls by
two residents. Finally, we discuss the deficiency findings regarding pressure
sores. Standard of Review Our standard of review on disputed issues of fact is whether
the ALJ Decision is supported by substantial evidence on the record as
a whole. See, e.g., Lake Cook Terrace Nursing Center, DAB
No. 1745 (2000). Our standard of review as to disputed issues of law is
whether the ALJ Decision is erroneous. Id. Analysis 1. The ALJ did not err in finding that Koester
was in substantial compliance with 42 C.F.R. � 483.25(h)(1). In considering the findings relating to this deficiency,
we first address whether the ALJ employed the correct burden of proof
to reach her determination that Koester was in substantial compliance
with the applicable participation requirement. We then consider whether
the ALJ erred by requiring HCFA to prove that actual harm occurred in
order to substantiate immediate jeopardy. Next, we consider HCFA's challenges
to the ALJ's factual findings on this issue. Finally, we turn to HCFA's
argument that the ALJ erred in failing to credit and give appropriate
weight to the testimony of its expert witnesses.
HCFA treated the regulatory requirement that HCFA's determination
that the level of noncompliance constituted immediate jeopardy must be
upheld unless clearly erroneous, as requiring the ALJ to evaluate all
of HCFA's evidence on this deficiency by that standard. For the reasons
given below, we conclude that the higher "clearly erroneous" standard
must be met to overturn HCFA's evaluation of the scope and severity of
a deficiency as presenting immediate jeopardy, but that a provider may
prevail on a claim that there was no such deficiency present by showing
substantial compliance by the preponderance of the evidence. In reviewing the F Tag 323 deficiency, the ALJ had to
answer two questions. See ALJ Decision at 4. The first question
was whether Koester was in substantial compliance with the provision.
To answer that question, the ALJ stated, and prior cases establish, that
HCFA must present a prima facie case with evidence that, if credible and
unrebutted, would constitute proof that Koester was not in substantial
compliance with the cited regulatory provisions. See ALJ Decision
at 2. Koester then had the ultimate burden of showing by the preponderance
of the evidence that it was in substantial compliance with each provision.
ALJ Decision at 2. Had Koester been found to be out of substantial compliance
with 42 C.F.R. � 483.25(h)(1), which was cited at the immediate jeopardy
level, then the second question presented would have been whether the
level of non-compliance found presented an immediate jeopardy to resident
health and safety. To answer that question, the regulations provide, and
the ALJ correctly observed, that HCFA's determination as to the level
of non-compliance must be upheld unless it is clearly erroneous. 42 C.F.R.
� 498.60(c)(2); ALJ Decision at 2. Further, the level of noncompliance
is subject to review only if a "successful challenge . . . would affect
the range of [CMP] amounts that HCFA could impose." 42 C.F.R. � 498.3(b)(13). This second question therefore arises only where the noncompliance was cited at a level of immediate jeopardy. As the Board has previously explained, no appeal may be had of HCFA's determination of the level of noncompliance, unless a change in that level would affect the available range of CMP, which would occur only when a facility challenges a finding by HCFA that the level of noncompliance was above the immediate jeopardy threshold so as to trigger a CMP range of $3050 or greater. 42 C.F.R. � 498.3(b)(13); Careplex of Silver Spring, DAB No. 1683, at 15 (1999). HCFA's regulations thus clearly provide for review of
the factual basis for a deficiency finding on which a proposed sanction
is based, but preclude review of the determination of the level of noncompliance
in a non-immediate jeopardy case. The preclusion of review of the second
question does not imply preclusion of the first, since the factual basis
of a noncompliance finding is expressly made appealable, so long as it
results in proposed imposition of one of the specified remedies. 42 C.F.R.
� 498.3(b)(12). Accordingly, it follows that the imposition of a higher
standard of review of determinations that a deficiency posed an immediate
jeopardy does not imply application of that higher standard to the review
of the factual basis of the underlying deficiency finding. See generally
Cross Creek Health Care Center, DAB No. 1665, at 18-20 (1998). On appeal, HCFA quoted the preamble to the regulations,
and cited several court cases, for the proposition that "the clearly erroneous
standard is a high burden for a facility to meet." HCFA Br. at 3-4. The
statement is correct but inapposite. Contrary to HCFA's argument, the
ALJ did not incorrectly apply the clearly erroneous standard in deciding
whether a deficiency existed as a matter of fact; rather, the ALJ correctly
applied the preponderance of the evidence standard to that question. The preamble language relied on by HCFA makes clear that
the reasoning behind raising the facility's burden of proof applies only
to the classification of the level of noncompliance represented by the
particular circumstances surrounding a deficiency finding. Thus, the high
burden is said to be appropriate in the case of "upsetting survey findings
relating to the level of noncompliance," because the factors of
"frequency and seriousness" by which the level is measured are not "mathematical
judgments for which there are clear or objectively measured boundaries."
59 Fed. Reg. 56,179 (emphasis added). The preamble goes on to state that
"[t]hus, in [CMP] cases, whether deficiencies pose immediate jeopardy,
or are widespread and cause actual harm that is not immediate jeopardy,
or are widespread and have a potential for more than minimal harm that
is not immediate jeopardy does not reflect that a precise point of noncompliance
has occurred but rather that a range of noncompliance has occurred which
may vary from facility to facility." Id. This discussion of the
difficulty and subjectivity of measuring a particular level of noncompliance
presupposes the existence of one or more deficiencies and assumes that
the question remaining is how frequent and serious the resulting noncompliance
is in its impact on residents. Because these "less than perfectly precise
concepts" are very difficult to quantify or second-guess, the preamble
makes clear that an ALJ is required to "uphold State or HCFA findings
on the seriousness of facility deficiencies in [CMP] cases unless
clearly erroneous." Id. (emphasis added). In the present case, the ALJ concluded that no deficiency
under 42 C.F.R. � 483.25(h)(1) existed. This conclusion was based on her
findings that Koester had proven that it was in substantial compliance
with those requirements. ALJ Decision at 12. As a result of that conclusion,
the ALJ found that no immediate jeopardy existed. Id. The ALJ went
on to also find that the immediate jeopardy determination was clearly
erroneous. Id. Where no deficiency exists, it necessarily follows that
no issue arises about the correct level of the deficiency. The Board previously
articulated this rule in Lake Cook Terrace Nursing Center, DAB
No. 1745, at 6 (2000), as follows -
While the further finding that the level was clearly erroneous
may hence not have been strictly necessary, we find no error in the ALJ's
conclusion. We therefore turn next to HCFA's challenges to the ALJ's conclusion
that Koester had proven that it was in substantial compliance with the
cited provision. For that purpose, the applicable standard is whether
there is substantial evidence in the record as a whole that supports the
ALJ's determination that Koester proved substantial compliance by the
preponderance of the evidence.
We find that HCFA misread the ALJ Decision as holding
that a resident must actually slip off the bed before a likelihood of
harm from improper use of side rails could be found. HCFA Br. at 5.
HCFA quoted an excerpt from the ALJ Decision which read:
ALJ Decision at 11, quoted in HCFA Br. at 14. From
this language, HCFA concluded that the ALJ interpreted the regulation
to require the resident to actually become "caught in the side rails,
or suspended from the restraint belt . . . before
harm is likely." HCFA Br. at 14. We disagree with HCFA's reading of the
ALJ's language. The Board has previously held that no showing of actual
harm is required to support a finding of immediate jeopardy if the risk
of harm is imminent and serious enough.
DAB No. 1726, at 38. While the phrasing may have been
less than completely clear, a close reading of the ALJ Decision as a whole
shows no inconsistency with our prior holdings. HCFA omitted the language
from the ALJ Decision which immediately follows its quotation, in which
the ALJ goes on to state -
ALJ Decision at 11. The ALJ then listed the specific facts and circumstances
that convinced her that, while a misuse of restraints and rails could
be indeed very dangerous, the manner in which they were used here did
not present an accident hazard. Id. The ALJ's observation that,
in the present case, no actual harm to the resident occurred does not
imply that immediate jeopardy could not result from noncompliance absent
actual harm in an appropriate case. The ALJ specifically stated that,
"[i]n another case," she might well find that a failure to use full-length
rails did present an accident hazard, "but not here." ALJ Decision at
11. The ALJ thus correctly considered both actual harm and the degree
of potential harm. After thus concluding that Koester was in substantial
compliance with this participation requirement, given the totality of
the surrounding facts, the ALJ then considered whether the immediate jeopardy
determination had been clearly erroneous. The ALJ noted that no actual
harm took place, but that, had there been noncompliance, the potential
for harm could have been very serious, even life-threatening. However,
that serious potential for harm was not presented here at all, given all
the facts credited by the ALJ in relation to the use of the restraint,
because proper procedures were followed in applying the restraint and
rails, and additional care was taken to minimize any residual risk. Therefore,
the ALJ concluded that the immediate jeopardy determination was also clearly
erroneous. We find no legal error in this conclusion. We therefore turn
to the specific circumstances which convinced the ALJ that the use of
the waist restraint and side rails here was not a hazard to determine
if the ALJ's findings were supported by the record.
The single episode which led to the deficiency finding
was the result of two surveyors' observations of R. 113 in bed one morning
with a waist restraint on and side rails raised on the upper part of the
bed but no side rails covering the lower part of the bed. The physician
and facility had concluded that R. 113 required a waist restraint in bed
because of his medical condition and his history. P. Ex. 75, at 27, 50.
The surveyors did not question the necessity for the waist restraint but
concluded that the use of side rails that did not extend the full length
of the bed violated guidance from both the FDA and the restraint manufacturer.
P. Ex. 30, at 39. They feared that R. 113 could potentially move off the
bed and become entangled or strangled by the restraint belt. Id.
They cited this condition as violating the requirement that residents
should be provided an environment as free from accident hazards as possible.
42 C.F.R. � 483.25(h)(2). In concluding that no accident hazard was present, the
ALJ stated that she considered the circumstances as a whole, and focused
on the following six specific factors as most important:
ALJ Decision at 11-12. We discuss HCFA's arguments as
to each in turn and explain why the record evidence as a whole is sufficient
to support the ALJ's findings. HCFA acknowledged that factors one and two were not themselves
in dispute, but argued that the ALJ erred by omitting from them the further
information offered in the surveyors' testimony that their real concern
was the "lack of continuous bed rails" and that "a properly applied waist
restraint allows for side to side movement, thereby necessitating bed
rails that do not have gaps." HCFA Br. at 11-12. The surveyors themselves,
as well as Koester staff, testified to the accuracy of the facts underlying
these two factors.(3) Tr. at 32 (Davis),
37 (Davis), 113 (Cobb), 301 (Gray), 332 (Wiley). The surveyors did not
have a concern about the selection of the particular restraint, the manner
in which it was applied to the patient or affixed to the bed, the positioning
of the patient in the bed, or the efficacy of using a waist restraint
with the resident while in bed. Tr. at 32, 88, 126-27. Their concern rather
was with the restraint system as a whole, i.e., the combination of the
type of side rail used with the waist restraint. Tr. at 33. HCFA's argument
about the potential for movement is more relevant to the third factor
and its assertion of a requirement for "continuous bed rails" is more
relevant to the sixth factor. We find no real dispute in the record concerning
the accuracy of the first two factors, and we discuss HCFA's proposed
additional information below in relation to the relevant factors. Regarding the third factor, the record contains considerable discussion about the kind of movement permitted by a properly-applied waist restraint. Ms. Davis, a nurse who was one of the surveyors, stated that "waist restraints allow the resident to roll from side to side and the waist is the only area that is secure so the bottom half of the body can move from side to side as well as the top half of the body." Tr. at 37. However, Ms. Cobb, another surveyor, testified that in her training and experience, how much side-to-side movement would be possible "differs with individuals, depending on their size and the size of the restraint . . . ." Tr. at 134. Koester's charge nurses testified that R. 113, in this restraint, which was properly applied, could only turn from left to right on his axis but could not move laterally in either direction. Tr. at 277-78 (Stine), 294 (Gray). The ALJ credited the latter assessment.(4) ALJ Decision at 11. The charge nurses testified as to the actual mobility of this patient in this restraint, and spoke from longer experience with his circumstances than the surveyors who testified that they observed him only briefly twice within fifteen minutes on one morning. As far as the fourth factor, the surveyors agreed with
Koester staff that R. 113 was small in stature, and uncontradicted testimony
established that he was between four feet and ten or eleven inches and
weighed about 130 pounds. Tr. at 127 (Cobb), 275 (Stine), 295 (Gray),
332 (Wiley); ALJ Decision at 7; see also P. Ex. 75, at 14. The
parties did dispute, both before the ALJ and on appeal, whether R. 113's
size made it impossible for him to slide off the sides of the bed or slip
"over, under, around, through, or between side rails." See ALJ
Decision at 11. The bed rails used were 37 inches long; the hospital bed
was stipulated to be 84 inches long; full length side rails are, according
to provider testimony that was not contradicted, about 57 inches long.(5)
One surveyor, Ms. Cobb, testified at one point that the
railing began about two inches from the top of the bed, making it unlikely
that a resident could fit over the rails, and ended "not much past [R.
113's] midsection," while, at another point, she described the side rail
as extending "from the midthigh up to the top of the bed" leaving R. 113's
"knees . . . free to move about." Tr. at 113-114, 131-34. Koester's witnesses
agreed that it was possible to swing one's legs to the side while in a
waist restraint, but testified that, in the case of this individual, his
legs could not "hang over the side of the bed" because his feet barely
reached the edge. Tr. at 291 (Gray), Tr. at 282 (Stine). Thus, asked how
R. 113's small stature related to his safety in this bed system, she explained:
"[H]is legs aren't long enough to go over the rail. . . . He is just not
able to do that. . . . Because of his size." Id. at 295-96;
see also Tr. at 299-02. HCFA's witnesses appeared to treat any possibility of
an extension of any portion of R. 113's body beyond the edge of the mattress
as presenting the danger of suffocation or chest compression. See,
e.g., Tr. at 134-36 (Cobb).(6) However,
none of HCFA's witnesses described any specific scenario whereby such
entrapment could occur without any portion of the body extending past
the edge and around or through the rails enough to dangle. See
P. Br. at 7-8 (and record cites therein). HCFA's argument on this point
seemed rather to be derivative from the FDA Alert and manufacturer's instructions,
which, as discussed in relation to the sixth factor, HCFA read as warning
of a danger of entrapment in any case where a waist restraint is used
in bed without full, continuous, covered side rails. See generally
HCFA Br. at 12; Tr. at 36-37 (Davis), 134-136 (Cobb). The ALJ, on the other hand, focused on whether, as a question
of fact, R. 113's legs could actually "reach over" the edge of the bed,
so that he could potentially move around or through the railings, rather
than, for example, simply touch the edge with his feet. See ALJ
Decision at 11. In this regard, she credited testimony that R. 113's
small stature and the constraints on his movement were such as to preclude
him from sliding past the edge of the bed so as to become entrapped and
incur the risk of suffocation or chest compression. To the extent that
HCFA's witnesses actually disagreed with Koester's staff about how far
R. 113's legs could reach around the end of the side rail and extend beyond
the edge of the bed, we defer to the ALJ's evaluation of the credibility
of the witnesses on this question of fact. We address in regard to the
sixth factor HCFA's position that entrapment is per se a risk because
the restraint system did not comply with manufacturer's instructions. The fifth factor involved the close monitoring provided
to R. 113. As the ALJ noted, the doctor ordered that the patient be monitored
every 30 minutes and released and repositioned for ten minutes every two
hours around the clock. ALJ Decision at 6; P. Ex. 75, at 24; Tr. at 296.
In addition to finding that the staff complied with that order, the ALJ
credited testimony of Koester staff that R. 113's room was located near
the nurses' station to allow monitoring and had video and audio equipment
which could be viewed at the nurses' station (in the nature of a baby
monitor set-up). ALJ Decision at 6; Tr. at 290-91 (Gray), 332-33 (Wiley).
Furthermore, the ALJ credited testimony that these measures were supplemented
at times by stationing a staff person to sit at the door and at times
by continuous one-on-one monitoring. ALJ Decision at 7; Tr. at 290 (Gray).
Ms. Davis testified, in response to Ms. Gray's assertion on the last point,
that she never saw anyone outside R. 113's door or in his room when she
made her observation of him during the survey. Tr. at 347. However, this
rebuttal does not prove that Ms. Gray was incorrect in her statements.
Ms. Gray's description was that, among the measures adopted to deal with
R. 113's propensity to fall (including use of a Posey alarm and a wheelchair
"lap buddy," as well as monitoring measures, and ultimately the waist
restraint), the provider "did one-on-one with him" in which a staff assistant
"stayed with the resident at all times." Tr. at 201. This assertion does
not imply that one-on-one was in place continuously 24 hours every day,
as HCFA inferred. Further, Ms. Gray was asked if Koester would ever "station
staff in or near his room," and responded that: "Resident 113 was right
at the nurses' station, his room was at the nurses' station. And, we would
have staff to sit outside the door so that they could - you know, if he
was to rustle around or move, they could be there to check." Tr. at 291.
Again, this testimony does not assert that someone was stationed by the
door at every minute. According to Ms. Cobb, Ms. Davis observed R. 113
for less than ten minutes on the morning of July 9, 1997 between 7:45
and 8 A.M. at which point the surveyors had completed their observations
and turned to writing their findings. Tr. at 163-65. Therefore, the ALJ's
finding that such monitoring was provided at times, supplementing the
round-the-clock monitoring at 30 minute intervals, is not undermined by
testimony that it was not observed during one period within a 15-minute
interval. The sixth factor is the most contentious. Neither side
contested the ALJ's conclusion that a failure to abide by manufacturer's
instructions is important but does not per se demonstrate an accident
hazard; rather, "all the specific circumstances must be evaluated." ALJ
Decision at 4, FFCL No. 2. HCFA strongly disputed, however, the ALJ's
conclusion that Koester did abide by the manufacturer's instructions
in the way it used the restraint here. HCFA argued that Koester's use
of partial rather than full side rails violated the manufacturer's instructions.
Further, HCFA argued that this misuse presented precisely the dangers
reflected in an FDA Alert relied on by the surveyors in assessing immediate
jeopardy. HCFA Br. at 8-9. Koester responded in its Plan of Correction that it was
complying with the manufacturer's instructions applicable at the time
by meeting the following requirements:
P. Ex. 30, at 32-33, 77; P. Br. at 5-6. The ALJ considered both the question of which instructions
were applicable and the question of how the applicable instructions should
be interpreted. She concluded that Koester's use of these side rails in
the up position, even without padding or full-length railing, was within
the ambit of the applicable manufacturer's instructions. ALJ Decision
at 8-11. It is uncontested that the side rails on R. 113 were in
the up position and were, as noted, � to 3/4 length. ALJ Decision at 4,
unchallenged FFCL No. 4. The surveyors agreed at the hearing, despite
some confusion, that the side rails used with R. 113 were not of the kind
generally known as a split rail system, which involves four smaller rails,
two on each side along the head and foot of the bed and a large gap between
them. Tr. at 87, 90; but see Tr. at 99-100; see also HCFA Ex. 10,
at 2 (photo of split rail).(7) HCFA argued
before us, however, that the ALJ was mistaken that it mattered whether
the rails were split rails or partial length side rails, because that
was "not the focus of the surveyors' concern," but rather they were worried
about Koester's failure to use rails that extended the full length of
the bed. HCFA Br. at 6-7. We disagree. The core of the dispute here was
over whether these side rails (not split rails) were adequate to comply
with the requirement for continuous rails in the up position. Although HCFA saw no relevant difference among them, it is clear that several versions of the manufacturer's printed instructions for proper use of restraints were in the record.(8) Compare HCFA Ex. 10, at 1; with P. Exs. 6, at 1; 7, at 3; 30, at 77; and 76, at 1; see also ALJ Decision at 8. The ALJ determined that the applicable version was that issued closest to the time of the survey, i.e., in 1993 rather than 1992, while the surveyors apparently had relied on the older version judging by the language used in the original 2567 form. ALJ Decision at 9-10; HCFA Ex. 3, at 5; P. Ex. 30, at 32. HCFA offered no persuasive reason why an older version of these safety instructions should be relied on rather than the most current version, and we therefore accept the ALJ's conclusion as to the applicable version. The later version, entitled "Safety Instructions for the
Use of Posey Restrictive Products," provided the following guidance:
P. Ex. 7, at 1. The ALJ noted that the language above
did not contain any caution to use only full length side rails
as opposed to the partial length side rails used with R. 113. ALJ Decision
at 11.(9) The injunction not to use side
rails of a kind that allow entrapment does not necessarily imply that
all side rails except full and continuous ones always present entrapment
risks regardless of the particular patient. It can be read, as Koester
suggests, to require an exercise of professional judgment to assess what
side rail system might allow such events in particular circumstances. In considering whether this reading is reasonable, it
is helpful to consider what changes were made from the older instructions
on which the surveyors relied. The corresponding section previously read
as follows:
HCFA Ex. 10, at 1. Given that the revision removed express language about avoiding partial length side rails and replaced it with language calling for an exercise of judgment about what side rail system fits the patient, the reasonable inference is that the manufacturer consciously concluded that partial length side rails were not a per se danger. We conclude that the ALJ's findings about the circumstances
surrounding the choice and use of this restraint system for R. 113 are
supported by substantial evidence. We further conclude that the ALJ reasonably
interpreted the applicable instructions as permitting the exercise of
professional judgment in light of the particular circumstances. We discuss
in the next section why we do not accept HCFA's arguments that the ALJ
improperly ignored the testimony of its expert witnesses across the board
regarding the risks and proper use of the R. 113's waist restraint and
side rails.
HCFA argued that the ALJ accepted two surveyors (Ms. Davis and Ms. Cobb) as expert witnesses and made no express findings that "their statements or opinions were not credible or merited little weight," and yet did not refer to or consider their testimony at all. HCFA Br. at 4. HCFA's argument both misstates the ALJ's Decision and misunderstands the role of expert witnesses. In general, as an appellate body, we do not disturb an
ALJ's assessment about the relative credibility of testimony by witnesses
who appear in person at the hearing absent a compelling reason to do so.
Thus, the Board has held that --
South Valley Health Care Center, DAB No. 1691,
at 22 (1999). Here, the ALJ did, in fact, reference the surveyors' testimony
repeatedly; however, she determined that some of their statements or factual
descriptions were simply "incorrect," misjudgments, or "mistaken." ALJ
Decision at 6, 7, 11. While she did not make a general finding that they
were not believable witnesses, or provide as explicit an explanation as
might have been desirable of her evaluation of each witness, she addressed
conflicts in the testimony and indicated which account she accepted and
what facts Koester had proven. See ALJ Decision at 6-11 passim. Accepting these witnesses as experts did not guarantee
that the ALJ would then accord greater weight to their testimony. The
ALJ expressly noted at the hearing that she would not necessarily do so.
Tr. at 35 (Davis), 119 (Cobb). The testimony reflected that each witness
had some relevant training and background (to differing degrees) that
the ALJ, as finder of fact, did not personally possess. Tr. at 35-37,
108-19. On that basis, the ALJ permitted them to offer opinion testimony
on narrow questions where that might assist her in understanding particular
issues, and thus to go beyond the opinions or inferences generally permitted
to lay witnesses. See generally Fed. Rules of Evid., Rules 701,
702. Further, much of the testimony which HCFA argued should have been
accorded more weight went not to expert opinions but to observations of
facts. On such matters, the question of expertise is not necessarily relevant.
In addition, much of the testimony involved was based on premises underlying
HCFA positions (such as the assumption that anything less than full side
rails were per se violations of the instructions and necessarily presented
the entrapment risks set out in the FDA Alert), which the ALJ rejected
as a result of her independent review of the applicable documents which
she was able to read and interpret herself. An expert's opinion lacks
relevance when based on factual foundations that are not proven. Furthermore, the purposes for which these witnesses were
accepted as experts were narrow and their qualifications were limited
in scope as well. HCFA did not seek to qualify them as experts overall.
Rather, the ALJ permitted them to answer specific questions when challenged
on the basis that they did not have sufficient qualifications to express
opinions on those matters. For example, the ALJ stated she would treat
Ms. Cobb as an expert witness (over objection) because Ms. Cobb might
assist the ALJ in evaluating the issue of what type of rail system the
surveyors were looking for to prevent falls.(10)
Tr. at 118-19. Ms. Cobb had testified that her professional training was
as a dietician, but also that she had had training and experience in how
to evaluate the proper use of restraints as a surveyor. Tr. at 109-11.
Ms. Cobb testified that she was not trained as a nurse and had never applied
a restraint or participated in a restraint assessment, although she had
previously observed residents in bed restraints as a surveyor. Tr. at
117, 138. The ALJ allowed her to testify as an expert witness, but noted
that other witnesses might be given greater weight. Tr. at 119. Ms. Davis, the other surveyor who observed R. 113, was
a registered nurse in addition to her training as a surveyor. Tr. at 28-29.
Again over objection, the ALJ agreed to hear her opinion to assist in
understanding a hypothetical (concerning whether the surveyors would have
reacted differently had a different waist restraint been used). Tr. at
34-39. Again, the ALJ noted that the witness's opinion would not necessarily
"carry the most weight." Tr. at 35. In addition, we note that the witnesses presented by Koester whose testimony the ALJ largely credited concerning this deficiency also had professional backgrounds and experience described in the record which were relevant to the weight properly given to their opinions, as well as greater opportunities to observe the facts and circumstances surrounding the resident and episode at issue. Ms. Stine was a licensed practical nurse for more than 14 years and was serving as charge nurse at Koester. Tr. at 248-49. Ms. Gray was also a charge nurse, had been at Koester for more than seven years, and was familiar with this resident. Tr. at 289-90. Ms. Wiley was a registered nurse, had worked at two other facilities, and had been at Koester for two years. Tr. at 323. Her work included observing and evaluating residents, developing care plans, and coordinating care with unit charge nurses. Tr. at 324. HCFA did not object to the presentation of their opinion testimony. See, e.g., Tr. at 332 (Wiley). In a case where an ALJ found the testimony of expert witnesses for one party "more convincing" than that of the other party, the Board held that it "is within the ALJ's authority to weigh the evidence and judge the credibility of each witness." Bernard J. Burke, M.D., DAB No. 1576, at 14 (1996). In considering the ALJ's assessment of witnesses' credibility, "we must abide by that determination absent a compelling reason not to." Id.; see also DAB No. 1726, at 8-9 (2000), Oak Lawn Pavilion, Inc., DAB No. 1638 (1997). We find no compelling reason to reject the ALJ's determination
about the relative credibility and persuasiveness of the testimony of
these witnesses. We conclude that the record as a whole, in light of the
testimony credited by the ALJ, contains substantial evidence in support
of the ALJ's conclusion that no accident hazard was present under all
the circumstances.
For the reasons explained above, we find no error in the ALJ's legal analysis of this deficiency finding, and we conclude that her factual findings are supported by substantial evidence in the record as a whole. Therefore, we sustain the ALJ's FFCLs numbered 5 through 8. 2. The ALJ's conclusion that Koester was in substantial
compliance with 42 C.F.R. � 483.25(h)(2) is not supported by substantial
evidence in the record. Falls by two different residents, R. 24 and R. 134,(11) under very different circumstances, are at issue here. R. 24 slipped to the bathroom floor while being assisted by a single aide. The aide was able to ease her to the floor without her fully falling but in the process R. 24 sustained a skin tear. R. 134 had a history of serious falls when he was found on the floor by his bed three times in just over 24 hours. In both situations, the surveyors determined that the
facility had failed to ensure that the resident received "adequate supervision
and assistance devices to prevent accidents." 42 C.F.R. � 483.25(h)(2).
The surveyors explained their assessment of the severity of this deficiency
in the Form 2567 as follows:
P. Ex. 30, at 26. In each case, the ALJ found that the
facility did "everything within reason" to provide adequate supervision
and assistance devices for the two residents who had suffered falls. ALJ
Decision at 13, 15. HCFA argued that, on the contrary, the staff failed
to provide either resident with even what the facility's own assessment
showed that they needed. HCFA Br. at 21. We first discuss the applicable standard imposed by the
regulations. Next, after careful examination of the record and for the
reasons explained below, we hold that substantial evidence supports the
ALJ's conclusion that Koester provided adequate supervision to R. 24 to
prevent accidents. See ALJ Decision at 13-14. For the reasons we
explain thereafter, however, we reverse the ALJ's finding concerning R.
134 because it is not supported by substantial evidence in the record,
which instead establishes that Koester did not take appropriate measures
to forestall his repeated falling.
The ALJ considered Koester's compliance with 42 C.F.R.
� 483.25(h)(2) in terms of whether the facility did "everything within
reason" in supervising these residents. ALJ Decision at 13-15. The
ALJ did not elaborate on the meaning of this phrase, and it is not clear
whether by it she meant to employ the standard required by the regulation.
See HCFA Br. at 21. We therefore address first the correct standard. In meeting this particular requirement, the facility must
ensure that its supervision is adequate to prevent accidents, in
order to meet the overall quality of care requirement to provide what
is necessary for each resident to "attain or maintain the highest practicable
. . . well-being." 42 C.F.R. � 483.25. The high obligation to ensure the
adequacy of the measures which it takes to effectuate this requirement
does place a high expectation on the facility to achieve results, but
it does not "amount to strict liability or require absolute success in
an obviously difficult task." DAB No. 1726, at 27 (2000). As the Board
explained in Woodstock, the law and regulations are designed to
focus on evaluating actual facility performance in meeting the purposes
of the program and to move away from simply imposing checklists of capacities
and services that must be available. Id. at 28-29. Under this "outcome-oriented"
approach, facilities have the flexibility to use a variety of methods
and approaches but they are responsible for achieving the required results.
Id. In ensuring adequate supervision, thus, a facility is not required
to do the impossible or be a guarantor against unforeseeable occurrence,
but is required to do everything in its power to prevent accidents.
With respect to R. 24, the surveyors noted that her medical
records indicated she had slipped to the floor on the morning of July
9, 1997 while being assisted to the bathroom. P. Ex. 30, at 40. A
minimum data set (M.D.S.) form for R. 24, completed on February 11, 1997,
and a second M.D.S. form completed on April 12, 1997 both reported R.
24 needing the physical assistance of two or more persons to move between
locations in her room and the adjacent corridor. P. Ex. 71, at 100, 113.
However, at the time of the incident, the nurse's notes report that a
single nurse aide was helping R. 24 ambulate the short distance from her
bed to the bathroom. R. 24 was also using a walker, but she nevertheless
lost her balance and "was assisted to sit down [on] the floor." P. Ex.
71, at 29-30. While R. 24 was helped to lower herself, rather than
fully falling, she sustained skin tears to her arm and shin in the process.
Id. at 30. HCFA contended that Koester itself had determined that
extensive assistance from two staff members was required for R. 24, and
that the facility's argument that the resident in fact at that point required
less assistance while ambulating in her room to the toilet is belied by
the very fact that she fell under those circumstances. HCFA Br. at 20. The ALJ, however, credited testimony of three Koester
staff members, Ms. Wiley, Ms. O'Brien and Ms. Stine, who agreed that the
assistance being provided was appropriate and adequate for R. 24
under all the circumstances of the incident. They stated that R. 24 could
and did safely manage for short distances, e.g., to the bathroom or from
chair to bed, with a walker and a single assist. ALJ Decision at 13; Tr.
at 253-54 (Stine); 309-10 (O'Brien), 334 (Wiley). Two staff members were
indeed needed to assist her with ambulating longer distances, e.g., to
the lounge or for meals. ALJ Decision at 13; Tr. at 334. The staff testified
that R. 24's mental condition varied significantly, so that she required
more supervision at some times than at others. ALJ Decision at 13; Tr.
at 309 (O'Brien); Tr. at 253 (Stine). As for the two-person assist noted in the M.D.S., Koester's
staff testified that that represented a report of the highest level of
support provided during the preceding seven days, but not necessarily
an assessment of the minimum level of support required from that point
on. Tr. at 333-34 (Wiley). The instructions for coding on the forms themselves
support that testimony. P. Ex. 71, at 100, 111. Neither party identified
any care plan or resident assessment that concluded that the level of
support needed perhaps only once during particular weeks in February and
April represented the baseline support that R. 24 needed in all circumstances.
The M.D.S. form does not disclose whether that assistance was needed only
when she ambulated outside her room and for longer distances, which the
facility clearly felt called for two-person assists. By contrast, after
the July 9th fall, R. 24 was reassessed and her care plan
changed to require assistance by two persons whenever she was being ambulated,
as reported in Koester's Plan of Correction. P. Ex. 71, at 11; P. Ex.
30, at 40. We defer to the ALJ's assessment of the credibility of
the witnesses' accounts of R. 24 varying care needs. Substantial evidence
supports the ALJ's determination that the record does not establish that
R. 24 had required and been documented as needing two persons to assist
with ambulation in her own room. ALJ Decision at 13. The nursing record for this resident did contain reports
of two earlier falls in June 1997. P. Ex. 71, at 21. One of those incidents
did resemble the circumstances that occurred on July 7, 1997. In the earlier
episode, a nurse aide was ambulating her to the bathroom when she fell
and the aide was not able to catch her, resulting in some injuries. Id.
at 22. However, no use of the walker is recorded in the earlier episode.
Nothing in the record establishes that Koester had assessed the resident
as needing to move to a two-person assist in ambulating to the bathroom.
The facility could reasonably have determined that the addition of a walker
would provide sufficient additional stability and that they could thereby
preserve as much independence and self-sufficiency as possible for the
resident. HCFA did not point to anything in the record to establish that
this would not be an appropriate measure to ensure the resident's safety.
Rather, HCFA argued that anything but the use of two-person assists was
inconsistent with Koester's own assessment of R. 24's needs. We do not
find that argument supported by the factual findings or by the evidence
in the record as a whole. The ALJ's conclusion that Koester complied with 42 C.F.R.
� 483.25(h)(2) in its treatment of R. 24 is affirmed.
With regard to R. 134, the surveyors found that, according
to his medical records, this resident had broken his hip as a result of
a prior fall while at the facility. P. Ex. 30, at 40-41. On July 2, 1997,
at 3:45 A.M., his records showed that he was found on the floor by his
bed, which resulted in some pain and bruising on his hip and thigh. Id.
at 41. The next morning at 4:15 A.M., he was again found on the floor
beside his bed resulting in a fracture of his left femur. Id. There
was no dispute that this resident needed extensive assistance for ambulation.
ALJ Decision at 17; P. Ex. 73. The surveyors noted that a bed alarm had
been discontinued in February and that � side rails were used, but found
that "the record was silent to any preventive measures in place to address
this resident's high risk for falls." P. Ex. 30, at 41. The ALJ accepted the explanation of Koester staff that
they had done all they could to avoid dangerous falls by R. 134, but were
stymied in their efforts because R. 134 was resistant, uncooperative,
and engaged in attention-getting, but self-destructive behaviors beyond
their control. ALJ Decision at 14-15. This finding was based on testimony
from a charge nurse that this resident was a noncompliant "attention seeker"
who would deliberately sit down on the floor, threaten to fall to get
staff into trouble, or actually fall deliberately. See Tr. at 297-98
(Gray). Koester did not point to any documentation in his assessments
or care plan of this behavior. There was testimony, however, that medication
he was on might have affected his ability to maintain balance, so that
his propensity to fall may also have reflected medical causes. Tr. at
82. In either case, it is clear that the facility was aware
that he was a falling risk and that he had seriously injured himself in
frequent falls in the past; in response, Koester had implemented a number
of measures at various times. These measures included the use of a Posey
body alarm. However, before the fall in question, the alarm was discontinued
at the resident's own request. The facility contends that "[c]ontinuation
of that device would have been improper absent resident's consent." P. Br.
at 18. We conclude that the standard imposed by the regulation
- that each resident must receive adequate supervision and assistance
devices to prevent accidents - was not met by the facility. The facility
did monitor this resident frequently, and was aware of his troublesome
behavior with regard to falls; nevertheless, the facility did not point
to anything in the record to demonstrate that it supplemented or replaced
the use of the warning alarm with effective measures to prevent further
falls. It is simply unacceptable to abdicate the duty to supervise or
use assistive devices to prevent falls even when the resident, for whatever
reason, is resistant, noncompliant, or difficult to deal with. We hold,
instead, that compliance with the standard involves consideration of a
variety of measures designed to prevent a resident from falling. When
an individual like R. 134, whose diagnosis includes cognitive impairment,
who frequently falls or threatens to fall, and who has a history of injuries
from falls is in the care of the facility, the facility must take appropriate
steps to prevent falling accidents from occurring whether or not the individual's
actions can be termed "deliberate" given his mental status. Where an individual
refuses a particular protective device (here, the body alarm), the facility
is still responsible under 42 C.F.R. � 483.25(h)(2) for protecting the
safety of that person. If the device is to be removed, the facility is
obliged to provide another means of supervision or assistance to prevent
falls. See generally DAB No. 1726, at 34 (2000). In short, while there is no dispute that the resident
had a right to refuse treatment, the facility had a countervailing duty
to protect the dependent individual under its care against accidents.
Certainly, if the facility was sufficiently aware of the resident's proclivity
for falling to have installed an alarm to begin with, then appropriate
alternative measures should have been put in place if the body alarm was
discontinued. The ALJ's conclusion that Koester complied with 42 C.F.R.
� 483.25(h)(2) in its treatment of R. 134 is reversed.
We conclude, as to the accident prevention deficiencies,
substantial evidence in the record supported the ALJ's findings that Koester
complied with the regulations as to one resident. However, we conclude
that her finding to the same effect as to a second resident is not supported
by substantial evidence. Rather, as to the second resident, the record
shows that Koester did not take appropriate measures to prevent falls.
Therefore, we vacate the ALJ's FFCL No. 9 and replace it with the following
substitute FFCL No. 9:
3. The ALJ's conclusion that Koester was in substantial
compliance with 42 C.F.R. 483.25(c) is not supported by substantial evidence
in the record. The pressure sore regulation has two prongs, both of which
are relevant to the deficiency findings here. First, section 483.25(c)(1)
provides that each facility must ensure that any resident who does not
have pressure sores on entering the facility does not develop any while
there "unless the individual's clinical condition demonstrates that they
were unavoidable." Second, section 483.25(c)(2) provides that the facility
must ensure that any resident who does have pressure sores "receives necessary
treatment and services to promote healing, prevent infection and prevent
new sores from developing." In assessing the level of noncompliance relating to pressure
sores, the surveyors explained in the Form 2567 as follows:
P. Ex. 30, at 26. The surveyors found that two residents
(known as R. 24 and R. 44) who entered the facility without pressure sores
had developed them while at the facility. P. Ex. 30, at 29. They determined
that the causes were avoidable, specifically that they were caused by
wearing inappropriate shoes. Id. A third patient (R. 30) suffered
from diabetes and vascular disease and had one leg amputated. Id.
at 30. The surveyors found that he had developed a pressure sore on the
heel of his remaining foot. The surveyors observed that he had been wearing
a new "pressure boot" and that dried substances were noted on the padding
when the boot was removed. Id. Finally, a fourth patient (R. 8)
had a pressure sore on her buttocks and a surveyor observed this resident
left with fecal matter in the area after toileting. Id. at 31. We address first what standard applies to the evaluation
of facility compliance with the participation requirements relating to
pressure sores. We then discuss the specific findings about the four individual
residents. In three instances, we conclude that the ALJ's factual findings
regarding the provider's treatment of the residents' pressure sores do
not support her legal determination that the provider was in compliance
with this quality of care standard. In relation to R. 30, however, we
conclude that substantial evidence supports the ALJ's finding that the
pressure sore at issue was unavoidable.
The standard on which the ALJ appeared to rely in finding
that Koester was in substantial compliance with this provision, as with
the preceding one, seemed to turn on whether the facility had done what
the ALJ considered to be "everything within reason." See, e.g.,
ALJ Decision at 18, 22. Again, this phrasing does not make clear whether
the ALJ considered the evidence in light of the correct regulatory standards.
See HCFA Br. at 19, 22. In meeting this particular requirement, the facility must
ensure no resident develops pressure sores unless clinically unavoidable
and that any resident with pressure sores receives necessary treatment
and services for healing, preventing infection and preventing future sores,
in order for the facility to meet the overall quality of care requirement
to provide what is necessary for each resident to "attain or maintain
the highest practicable . . . well-being." 42 C.F.R. � 483.25. In the preamble to the final regulations, HCFA noted that
some commenters sought to have the term "ensure" replaced with less demanding
language such as "provide" or "enable." They argued "that a facility cannot
reasonably be expected to 'ensure' that a desired outcome will occur,
especially with respect to all of the factors that may affect frail, aged
nursing home residents." 56 Fed. Reg. 48826, at 48850 (Sept. 26, 1991).
HCFA responded that -
Id. The preamble further stated that the expectation
in the regulations was that a "facility should always furnish the necessary
treatment and services to prevent the development of pressure sores or,
at the least, to promote the healing of sores that have developed." Id.
at 48851. We therefore review the conclusions relating to pressure
sores in light of the regulatory standard that a facility should go beyond
merely what seems reasonable to, instead, always furnish what is necessary
to prevent new sores unless clinically unavoidable, and to treat existing
ones as needed.
The ALJ found that R. 44 had no pressure sores on admission to the facility and then developed pressure sores as a result of wearing shoes provided by her family. ALJ Decision at 18-22. HCFA contended, through its surveyors and in its brief, that the facility was obligated to intervene whenever a situation is likely to cause the development of pressure sores. Tr. at 176, 195-6; HCFA Br. at 17. One of the surveyors, Ms. Tobias, stated that since pressure sores can be caused by unrelieved pressure on a resident's skin, new shoes should be avoided, especially for high risk residents who are dependent on the staff for daily needs. Tr. at 176, 195-96. As the ALJ found, Resident 44 suffered from ALS (amyotrophic
lateral sclerosis), had had a prior stroke, had aphasia, was limited in
mobility and was totally dependent on the staff for all her care. All
of these conditions placed her at high risk for pressure sores. ALJ Decision
at 19. The resident's daughter preferred for the resident to
wear a certain pair of shoes that had been brought in by the family because
they were the "style of shoe she had always worn." Tr. at 257 (Stine),
326 (Wiley). According to Ms. Stine (a licensed practical nurse at Koester),
the family was informed that "they no longer fit her feet right because
her feet were showing some contracturing from her disease process." Tr.
at 257. Ms. Wiley called the daughter and said that the shoes had caused
a red area and asked that she bring in a larger size. The facility waited
several days and then put properly-fitting tennis shoes on the resident.
Tr. at 326. When the daughter next visited, she took home the tennis shoes,
because she felt her mother would never have worn them, and replaced them
with the ill-fitting shoes, which were the type her mother had "always
worn" as a dancer "in her younger days." Tr. at 327-28. Clearly, thus,
Koester's own witnesses establish that the facility staff knew that these
shoes were medically inappropriate for the resident's condition and had
already shown that they presented a danger to her skin integrity. Tr.
at 326-28, 339-40 (Wiley). If shoes provided by family members were "too
small" and required a "breaking in" period, as the nurses testified that
these would, then it seems unlikely that such shoes could be suitable
for an individual with a medically-caused proclivity towards pressure
sores. See Tr. at 339-40. The staff asked the
daughter twice over ten days to bring in different shoes, but she did
not. See Tr. at 200 (Tobias). At this juncture, the staff complied with the daughter's
wishes and regularly put the shoes the daughter had provided on the dependent
resident, even though they had already observed that the shoes caused
a persistent area of skin redness (the essential definition of a Stage
1 pressure sore for the minimum data set assessment). See, e.g.,
P. Ex. 74 at 19. An open blister followed soon after. P. Ex. 74, at 35.
The facility considered having a podiatrist determine the footwear needs
of R. 44, but no such evaluation occurred until after the development
of the blister in question. P. Ex. 74, at 35. The ALJ concluded that the provider was in substantial compliance with the standard. ALJ Decision at 21-22. We disagree. The facility is not simply absolved of responsibility for providing the care needed to prevent pressure sores by the family's wish to see their relative dressed as she had always been. That would be inconsistent with the regulatory purpose discussed above. The ALJ erred in considering treatment or action taken by a facility after a pressure sore has been allowed to develop as an adequate substitute for the prevention of sores from the start. The regulation requires that the facility ensure that pressure sores do not develop, unless clinically unavoidable. The facility did not contend that this pressure sore was clinically unavoidable. The Board has previously held that a facility must provide all necessary care and services to prevent the development of pressure sores, rather than just provide prompt treatment after they develop, particularly where the residents involved were known to have a high risk of developing sores. See DAB No. 1665. While it is understandable that a facility would wish
to accommodate the preferences of a resident or his/her family members,
the facility has an obligation under the regulations to take any necessary
precautions to prevent pressure sores. Certainly, the facility cannot
shift the blame for its inaction to the daughter not providing different
shoes at their request. The facility should accommodate the family's preferences
as much as possible, but must still take necessary measures to prevent
the predictable consequence of pressure sores. Such measures might have,
for example, included a prompt medical evaluation, consultation with a
podiatrist about shoe types that might minimize risk while preserving
some of the appearance important to the family, allowing the resident
to use slippers or other informal footwear whenever possible, or investigating
methods of stretching or padding the shoes to avoid injury. With respect
to R. 44, there is no evidence that any precautions to prevent
pressure sores were taken, once the daughter removed the tennis shoes. Clearly, the facility itself did not believe that its
overriding legal duty was to please the family members. After the first
red area developed, the facility had put on the tennis shoes even though
the daughter had expressed her strong preference for the new shoes. After
the blister finally developed, the facility stated that "preventive interventions
were undertaken including providing slippers . . . and moon boots to prevent
progression of the sore." P. Br. at 15. If such interventions were appropriate
after the blister, appropriate measures should have been instituted from
the point where the facility had assessed the risk to skin integrity presented
by the new shoes. We conclude that HCFA established its prima facie case
by showing that R. 44 did not have pressure sores upon entering the facility,
but subsequently developed such sores. Koester, therefore, had to show
that the development of these sores was clinically unavoidable in order
to sustain its burden of proof, not merely that the sores were later treated.
No such showing was made by the facility. We therefore reverse the ALJ's
conclusion that Koester was in substantial compliance with the regulations
in its care of R. 44, both because her finding that Koester had done everything
reasonable was not supported by evidence in the record as a whole and
because, under the correct regulatory standard, the facts established
show that the pressure sore was not unavoidable given proper care.
One surveyor (Ms. Grimes) recorded the following episode
in R. 8's care observed during the survey:
P. Ex. 30, at 31. It is undisputed that this resident
had a pressure sore in the area where the fecal matter was present, and
that she was not properly cleaned until the attending nurse dressed the
sore. ALJ Decision at 23. HCFA argued that this resident was thus improperly cleaned
after toileting, so that fecal matter was present at the site of a pressure
sore. Given R. 8's serious illnesses (including cancer and peripheral
vascular disease), this treatment both increased her risk of a new pressure
sore and exposed the existing one to possible infection. HCFA Br. at 18.
Koester argued that this resident was too large and unstable in balance,
to be safely cleaned on the toilet, so that aides would finish cleaning
her in bed. P. Br. at 16. Koester contended that it would have made little
difference to have completed the cleaning because the nurses arrived at
that point to change the dressing in that area, which was water-tight,
and therefore protected the pressure sore from contact with the fecal
matter. Id. The ALJ found the following facts, based on the testimony
received at the hearing: �Witnesses for both parties agreed that the nurse aides were able to clean the skin area around the sores, although they were not permitted to change the dressing. �They further agreed that there was no reason for the
aides not to clean the area and that "good nursing practice" included
such cleaning, even if the imminent arrival of a nurse to change the dressing
is anticipated. �Koester's practice was "for nurse aides to clean a resident
who has soiled herself and tell the charge nurse that the dressing is
soiled and needs changing." �The surveyor was present for the arrival of the nurse
and was informed by the aides that they had completed R. 8's incontinent
care and returned her to bed. �When the nurse arrived, the aides turned the resident
over for the nurse to change R. 8's dressing. �It was "poor nursing practice" to leave R. 8 in this
"degrading and unsanitary condition." ALJ Decision at 23-24 Nevertheless, the ALJ concluded
that this incident did not actually harm R. 8, because the existing pressure
sore was protected by the dressing and the fecal matter was not in contact
with skin areas long enough to contribute to any new pressure sores. Id.
at 23. Further, the ALJ held that this was an isolated omission which
was quickly attended to by the nurse. The ALJ held that, under these circumstances,
she did not find any deficiency, especially since HCFA failed to show
that it was a regular practice of the facility "to leave residents with
fecal matter clinging to their skin." ALJ Decision at 24. The ALJ found substantial compliance largely because the
incident was isolated, and the resident was not actually harmed. She nevertheless
suggested that she would have found that leaving residents in this condition
without promptly cleaning them would "clearly . . . constitute
a deficiency," without indicating that such a finding would require proof
of actual harm occurring to the residents. Cf. ALJ Decision at
24. Indeed, it is clear that the potential for causing more
than minimal harm is sufficient to demonstrate a failure of substantial
compliance under HCFA's regulations, without a finding of actual harm.
42 C.F.R. � 488.404(b)(2) (emphasis added). Further, an isolated
incident, if serious enough, may indicate problems in the facility since
a survey can only be a sample of facility conditions, especially given
that this deficiency would not necessarily have been detectable in a record
review. Lake City Extended Care Center, DAB No. 1658, at 14-15
(1998) ("[T]he regulatory scheme . . . assumes that any deficiency that
has a potential for more than minimal harm is necessarily indicative of
problems in the facility which need to be corrected."). It is also clear
that noncompliance exists even in the case of an isolated problem, where
the findings involve more than a potential for minimal harm, though a
pattern of such practices indeed may justify finding a higher level of
noncompliance. 42 C.F.R. � 488.404(b)(2); 42 C.F.R. � 488.301 (substantial
compliance means no deficiencies posing risk greater than the potential
for minimal harm). Substantial evidence supports the ALJ's finding that no
harm actually occurred here because the dressing did not leak and the
delay in cleaning was brief. However, the ALJ did not make any finding
that the potential for more than minimal harm was absent too, nor did
she explain why she ignored ample testimony in the record that the presence
of fecal matter near a pressure sore in a patient already at high risk
for sores increased the risk of developing infection or new sores
in the area. See, e.g., Tr. at 233, 238 (Grimes). We thus conclude that the facts found by the ALJ do not
support her conclusion that no deficiency was present. Under the legal
standard for assessing compliance with requirements for preventing and
treating pressure sores, the factual findings, and the record evidence
as a whole, established that Koester was not in substantial compliance
with this provision.
With respect to R. 30, the ALJ concluded that the provider
properly cared for this resident's pressure sores. ALJ Decision at 23.
R. 30 had diabetes and vascular disease. Id. at 22; Tr. at 269;
P. Ex. 72, at 68. Because his disease process had caused and was likely
to cause pressure sores and damage to his feet, he was fitted with a special
pressure boot by a physical therapist. Tr. at 224, 363;
P. Ex. 72, at 33. When the surveyors observed this resident, they felt
that an unusual bend in the boot had caused development of a pressure
sore in its vicinity. Tr. at 223 and 362-63 (Grimes).
They also observed that a substance of some kind was present
in the lining of the boot, which caused them concern. Tr.
at 220 (Grimes). Koester offered testimony, which the ALJ found credible,
that -- �the substance discovered by the surveyors in his boot
was actually an ointment designed to prevent pressure sores, �the boot was designed by occupational therapists as part
of R. 30's ongoing care by a podiatrist, Dr. Bailey, �the sore that did develop was not related to his new
boot, and �instead, the sore was clinically unavoidable as a result
of the disease process that had already cost R. 30 his other leg. Tr. at 269-74 (Stine); P. Ex. 72, at 33. Unlike the situation
discussed above, where inappropriate new shoes were provided by family
members, the footwear here was prescribed precisely in an effort to prevent
pressure sores in a high risk situation. Id. We defer to the ALJ's
assessment that the witnesses on this question presented by Koester were
more credible. Hence, we agree that in this instance the facility took
all appropriate precautions, and that the pressure sore in question was
not preventable. The ALJ's findings are thus supported by substantial evidence
and her conclusions of law are appropriate.
With respect to R. 24, the ALJ's conclusion that the facility
was in substantial compliance with the pressure sore regulation is supported
by substantial evidence. While R. 24, like R. 44 (see discussion in Part
B, above) did not develop pressure sores until after her arrival at the
facility, the ALJ found, and the record establishes, that R. 24's sores
were in fact unavoidable, and that the facility used all proper means
to prevent the sores, as well as to treat them after they developed. R. 24 was known to have very fragile skin and to be at
risk for skin tears. As with R. 44, R. 24 was provided shoes by her family
which resulted in the development of blisters. Here, however, the residents'
situations diverge. The facility had used slippers for this resident.
These shoes were provided at the request of the resident's podiatrist,
and were specifically intended to allow relief from the pedal edema that
resulted from R. 24's circulatory ailments. Tr. at 254-55 (Seine), 324-25
(Wiley). Further, the shoes were adjustable, were not observed to be ill-fitting,
were monitored by the facility when a blister or red area developed, and
were thereupon promptly removed. Tr. at 325-26, 338 (Wiley). Given that the facility relied on the expertise of the
patient's treating physician (the podiatrist in this instance), carried
out his directives, and took other steps to monitor and treat the resident's
condition, the ALJ's determination that the facility was in compliance
is supported by substantial evidence. See DAB No. 1745, at 11;
Beverly Health and Rehabilitation-Spring Hill, DAB No. 1646, at
44 (1999). In contrast with its actions concerning R. 44, where the facility
allowed the resident to wear footwear which it knew was not proper for
her skin sensitivity, the actions of the facility were proper with regard
to R. 24.
We conclude, as to the pressure sore deficiencies, two
out of four instances cited by the surveyors demonstrate a failure by
the facility to ensure that pressure sores do not develop or to properly
treat existing pressure sores. Therefore, we vacate the ALJ's FFCL No.
10 and replace it with the following substitute FFCL No. 10:
4. The proposed penalty of $50 per day for 50
days of violation is appropriate. While we have affirmed the ALJ in overturning the finding
on which immediate jeopardy was based, as well as her findings that the
facility was not in violation of the cited regulations with respect to
R. 30 and R. 24, we have found that Koester nevertheless was not in substantial
compliance during the 50 days. Since the amount of the penalty proposed
for that period was the minimum amount provided in the regulations, there
is no reason to remand this case to the ALJ. Under HCFA's regulations,
the ALJ and this Board, having found that a basis for imposing a CMP exists,
have no authority to "[s]et a penalty of zero or reduce a penalty to zero."
42 C.F.R. � 488.1348(e). We therefore reinstate the proposed penalty without
remand. We vacate the ALJ's FFCL No. 11, and substitute the following
FFCL:
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JUDGE | |
Donald F. Garrett M. Terry Johnson Marc R. Hillson |
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FOOTNOTES | |
1. The surveyors reported their findings in a Statement of Deficiencies on HCFA Form 2567L and cited each deficiency in compliance with a participation requirement by an "F Tag" number corresponding to a particular regulatory provision. See P. Ex. 30; see also HCFA Ex. 3. The 2567L was revised, and unless otherwise specified, our discussion refers to the later version which is in the record as Petitioner Exhibit 30 (which also contains Koester's Plan of Correction responding to the deficiency findings). Each deficiency was evaluated on a scale that reflected the scope and severity of the problem, from those that presented no risk beyond the potential for causing minimal harm to those that presented immediate jeopardy to resident health or safety. 2. HCFA misnumbered FFCLs Nos. 9 and 10, but quoted the language so it is clear that these are the FFCLs to which HCFA excepted. Cf. HCFA Br. at 16, 20. HCFA did not name an exception to FFCL No. 11 but its arguments necessarily imply an exception to the ultimate conclusion. 3. As mentioned above, we discuss why we defer to the ALJ's determinations on witness credibility issues in detail in the next section. For purposes of this discussion, we address whether substantial evidence exists in the record as a whole to support the findings, given the testimony credited by the ALJ. 4. In any case, it is not obvious that the two descriptions are necessarily inconsistent. It is entirely possible to visualize a patient whose waist is immobilized except for pivoting from side to side on an linear axis but who can nevertheless (given sufficient physical strength) bend at the waist to swing arms or legs in either direction. 5. It appears that the reference to the side rails as � to 3/4 length was based on these dimensions, being roughly 3/4 the length of full side rails and � the length of the bed. ALJ Decision at 7. 6. HCFA bolstered the surveyors' testimony about the high risks of using anything less than full-length bed rails by pointing out that Ms. Davis had once witnessed an entrapment involving less than full-length bed rails. HCFA Br. at 8, n .2. However, Ms. Davis testified that the resident in the situation she witnessed was caught in the space between the top half of a side rail and the headboard of a bed. Tr. at 38. Here, however, there was no suggestion that R. 113 could possibly have moved from his position about 21 inches below the headboard in the center of his bed and then have squeezed through the two inches between this side rail and the headboard. 7. In the Statement of Deficiencies, the surveyors had observed that R. 113's bed "had the top rails of a split rail system up" and "the bottom split rails were not on the bed." P. Ex. 30, at 32. However, at the hearing, as noted above, the surveyors agreed with Koester staff that the side rail system used for R. 113 resembled one shown in photographs of the partial length rather than the two-piece split rail variety. See Tr. at 121-22; P. Ex. 76, at 2, 7. 8. We note that it was undisputed that the relevant manufacturer was Posey Company, which produced the waist restraint. The manufacturer of the side rails submitted a statement that it did not publish guidelines on the use of its side rails with restraints, deferring rather to the restraint manufacturer, but also asserted that it had received no "complaints regarding the use of siderails with properly applied restraints." P. Ex. 30, at 32 and 79; ALJ Decision at 8, n.5. 9. Koester submitted with its Plan of Correction a version which warned that - All siderails MUST be in the up position when using restraints. If necessary, use a siderail cover, especially with split siderails, to prevent the patient's body from going under, around, through, or between the siderails. P. Ex. 30, at 77. As the ALJ noted, this version also contains no requirement to use full side rails or rail covers in all cases. ALJ Decision at 10-11. 10. This question never received a response, however. See Tr. at 117-21; P. Br. at 9-10. 11. This resident is also referred to in places in the record as R. 43 and R. 131, but the parties do not dispute the resident's identity. ALJ Decision at 12, n.8. |
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