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Department of Health and Human Services DEPARTMENTAL APPEALS BOARD Civil Remedies Division |
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Brier Oak Terrace Care Center, |
DATE: April 26, 2001 |
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Health Care Financing Administration
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Docket No.C-99-362
Decision No. CR766 |
| DECISION | |
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DECISION I decide that the Health Care Financing Administration
(HCFA) was authorized to impose sanctions on Brier Oak Terrace Care Center
(Petitioner, Brier Oak) including a civil money penalty for the period
November 19, 1998 to January 22, 1999, and denial of payment for new admissions
for the period December 25, 1998 through January 22, 1999, based on Petitioner's
failure to substantially comply with the requirements for Medicare participation
at 42 C.F.R. § 483.25(c). I. Background Petitioner is a skilled nursing facility located in Los
Angeles, California. The Los Angeles County Department of Health Services
(State survey agency) conducted a complaint survey of Petitioner on November
19, 1998. The survey found that Petitioner was not in substantial compliance
with the requirements for Medicare participation. The Statement of Deficiencies
identified a deficiency, F-Tag 314, under 42 C.F.R. § 483.25(c) ("Pressure
sores"). According to the Statement of Deficiencies, a review of
the records for "Resident 2" showed that, on October 14, 1998, he was
"assessed with a blister on both heels" and that there was no indication
that Petitioner had previously taken measures "to relieve pressure on
the resident's heels." HCFA Ex. 1, at 2, 4. The State survey agency and
HCFA determined that this was a deficiency that constituted no actual
harm with a potential for more than minimal harm but not immediate jeopardy.
HCFA Ex. 5, at 2; Tr. at 31-32, 362. By letters dated December 10, 1998, HCFA informed Petitioner
that it concurred with all of the State survey agency findings. HCFA's
letter also informed Petitioner that, based on Petitioner's noncompliance,
it was imposing the following remedies:
HCFA stated that these sanctions would continue in effect
until HCFA either determined that Petitioner is in substantial compliance
with the applicable participation requirements or terminated Petitioner's
provider agreement. HCFA Exs. 2 and 3. By letter dated February 18, 1999, HCFA notified Petitioner
that the follow-up survey completed on January 22, 1999 found that Petitioner
was in substantial compliance effective January 22. HCFA stated that,
accordingly, Petitioner's Medicare provider agreement would not be terminated,
the denial of payment for new admissions which went into effect on December
25, 1998 was prospectively rescinded effective January 22, and the civil
money penalty of $500 per day which began accruing on November 19, 1998
stopped accruing on January 22. HCFA Ex. 4. Petitioner requested a hearing by letter dated February
9, 1999. This case was assigned to other Administrativ Law Judges (ALJs)
before being reassigned to me. On March 22, 2000, Petitioner filed a motion
for summary judgment, which HCFA opposed. I denied Petitioner's motion
in a ruling dated May 22, 2000, on the ground that there were material
facts in dispute, and I held a hearing in this case on June 6 - 8, 2000.
At the hearing, I admitted into evidence Petitioner's Exhibits 1, 3-4,
8 and part of Petitioner's Exhibit 11;(1)
HCFA's Exhibits 1-8, 10-13, and 15; and ALJ Exhibits 1 and 2. HCFA presented
the following witnesses: John Motter, R.N., a HCFA employee who reviewed
the state survey findings in this case and qualified as an expert in nursing
and in HCFA's procedures for reviewing state agency survey findings; Nancy
Stotts, R.N., Ph.D., an expert in nursing and in wound care; Erno S. Daniel,
Ph.D., M.D., a medical expert in geriatric medicine and in wound care;
and Paula J. Perse, R.N., a HCFA employee who reviewed the State survey
findings in this case. Petitioner presented the following witnesses: Wendy
Chen, Ph.D., who provided services as a dietician at Brier Oak in October
1998; Robert D. Cortez, R.N., director of nursing at Brier Oak in 1998;
Lawrence R. Brooks, M.D., Resident 2's physician at Brier Oak and currently
medical director at Brier Oak; Crisanto Sullano, B.S., who provided physical
therapy services to Resident 2; Bonny Flemister, R.N., M.S., an expert
in the prevention, assessment, and treatment of pressure ulcers in adults
and the elderly; and Victor Gura, M.D., an expert in the assessment, prevention,
and treatment of pressure ulcers. After the hearing, the parties both
filed post-hearing briefs and replies. My decision in this case is based
on the parties' briefs and exhibits and the transcript of the hearing. II. Applicable law Petitioner is subject to periodic surveys to determine its compliance with the statutory and regulatory requirements of participation imposed on all skilled nursing facilities. See generally section 1819 of the Social Security Act; 42 C.F.R. Parts 483, 488, and 489. The participation requirement at issue here is one of several "quality of care" requirements at 42 C.F.R. § 483.25 which share the 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." Subsection (c) provides as follows:
The Departmental Appeals Board addressed the meaning of
this requirement in Koester Pavilion, DAB No. 1750 (2000) as follows:
DAB No. 1750, at 32. In order to prevail, Petitioner must meet the burden of
proof described in Hillman Rehabilitation Center, DAB No. 1611
(1997), aff'd, Hillman Rehabilitation Center v. U.S. Dep't
of Health and Human Services, No. 98- 3789, at 21 - 38 (D.N.J. May
13, 1999). Thus, HCFA must present a prima facie case with evidence that,
if credible and unrebutted, would constitute proof that Petitioner was
not in substantial compliance with 42 C.F.R. § 483.25(c). Petitioner then
has the ultimate burden of showing by the preponderance of the evidence
that it was in substantial compliance with this requirement. Specifically,
HCFA must show that Resident 2 did not have pressure sores upon entering
Brier Oak, but subsequently developed such sores. If HCFA makes this showing,
then Petitioner must show that the development of these sores was unavoidable
in order to establish its case. See DAB No. 1750, at 35. If I determine that Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(c), and that HCFA thus established the basis for the imposition of a civil money penalty, I must resolve the question of whether the civil money penalty of $500 per day imposed by HCFA was reasonable. The regulations authorize the imposition of penalties "in the range of $50-$3,000 per day" for "deficiencies that do not constitute immediate jeopardy, but either caused actual harm, or caused no actual harm, but have the potential for more than minimal harm." 42 C.F.R. § 488.438(a)(2) (now redesignated as § 488.438(a)(ii)). HCFA's determination as to the facility's level of noncompliance is not subject to my review. 42 C.F.R. § 498.3(d)(10)(ii). Under 42 C.F.R. § 488.438(e), I may not:
I am not obligated to presume that HCFA correctly assessed
the evidence and factors in setting the amount of the civil money penalty,
but I am bound to make an independent determination of whether the amount
set by HCFA is reasonable based on the evidence as fully developed in
the hearing. CarePlex of Silver Spring, DAB No. 1683, at 18 (1999),
citing DAB CR536, at 14. III. Issues, Findings of Fact, and Conclusions of Law
The issues in this case are: (1) whether Resident 2 developed
pressure sores on his heels; (2) if so, whether these pressure sores were
avoidable; and (3) if Resident 2 developed pressure sores which were avoidable,
whether the amount of the civil money penalty that HCFA determined to
impose for this deficiency was reasonable. B. Findings of Fact and Conclusions
of Law (FFCLs) I make the following findings of fact and conclusions of law to support my decision that HCFA was authorized to impose a civil money penalty of $500 per day for the period November 19, 1998 to January 22, 1999, and a denial of payment for new admissions for the period December 25, 1998 through January 22, 1999.
C. Discussion The blisters on Resident 2's heels were pressure
sores. The initial question presented by this case is whether
the blisters on Resident 2's heels were pressure sores, since the regulation
which Petitioner was alleged to have violated relates only to pressure
sores, not other skin lesions. This question arises because, in the contemporaneous
clinical record for Resident 2 maintained by Petitioner, the blisters
are never identified as pressure sores, or pressure ulcers or decubitus
ulcers--other terms which are understood to refer to pressure sores, but
simply as "blisters." I conclude that the preponderance of the evidence
establishes that the blisters were pressure sores.(2)
Resident 2 had numerous risk factors for pressure sores when he was admitted
to Brier Oak. He was in bed for hours at a time each day during the two
weeks before the blisters were noted, and experienced sufficient unrelieved
pressure on his heels to cause pressure sores. Three days before the blisters
were noted, Resident 2 developed pressure sores on his left buttock, making
it likely that other pressure sores would develop. As described in the
clinical record for Resident 2, the blisters at issue here were located
on Resident 2's heels, where pressure sores commonly occur, and had the
appearance of Stage II pressure sores. Petitioner's actions after the
blisters were noted show that Petitioner recognized that they were pressure
sores. Resident 2's physician ordered treatment for the blisters that
was consistent with a diagnosis of pressure sores and ordered that heel
protectors be used. In addition, Petitioner's plan of care for Resident
2 included the blisters as a problem and identified a goal of preventing
skin breakdown by employing heel protectors. Finally, there was no credible
evidence to support Petitioner's position that the probable cause of the
blisters was friction from rubbing shoes rather than unrelieved pressure.
Taken together, these facts clearly support an inference that the blisters
were pressure sores. Although, as discussed below, Petitioner raised some
disputes of fact, the evidence on which Petitioner relied does not support
its case. I note preliminarily that Petitioner argued that the survey
was too limited to determine that the blisters on Resident 2's heels were
pressure sores. It is irrelevant for purposes of this case whether the
surveyors obtained sufficient information to make this determination,
however. Under 42 C.F.R. Part 498, a petitioner is entitled to a de novo
hearing on the finding of noncompliance leading to a remedy. Thus, I may
properly consider evidence not considered by the surveyors or by HCFA
when it determined to impose the civil money penalty. See DAB No.
1683, at 17. The clinical record for Resident 2 shows that from October 1 - 13, 1998, Resident 2 was in bed for 16 consecutive hours each day, ostensibly subjecting his heels to unrelieved pressure for that length of time. Nevertheless, Petitioner took the position that Resident 2 would have moved his legs in bed to relieve pressure on his heels, so that the blisters could not be pressure sores. Petitioner relied on evidence that Resident 2's physical therapist had evaluated Resident 2 as having sufficient strength in both his legs to move them against the force of gravity without assistance (although not through a full range of motion) and as having reacted to a pinprick on his foot. P. Ex. 1, at 110-111; Tr. at 454-461. In further support of its position, Petitioner pointed out that, on the day of his admission, Resident 2 was noted to have moved toward the edge of his bed, leading Petitioner to use side rails on his bed (P. Ex. 1, at 116), and that Resident 2 was able, with assistance, to take "shuffling steps" for a distance of up to 45 feet (P. Ex. 1, at 114-115). I do not find this evidence persuasive. Dr. Daniel testified that "older people have altered sensorium at many levels, altered ability to respond to various things," so that Resident 2's leg strength had "zero predictive value" with respect to whether he would in fact have moved his legs in a manner sufficient to relieve pressure on his heels. Tr. at 269-270. Since Dr. Daniel is an expert in geriatric medicine, his testimony in this regard carries great weight. Moreover, the Minimum Data Set prepared by Petitioner for Resident 2 dated October 13, 1998 shows that Resident 2 required the assistance of another person to move in bed. P. Ex. 1, at 85; Tr. at 337-339. In addition, physical therapy evaluations for the period October 1 - 14, 1998 indicate that Resident 2 required assistance with bed mobility. P. Ex. 1, at 113-115. Thus, I conclude that Resident 2's limited ability to lift his heels was not sufficient to enable him to reposition himself in bed so as to relieve pressure on his heels and thus to prevent pressure sores from developing there. Petitioner argued in the alternative that, even if Resident
2 did not have the ability to move to relieve pressure on his heels, he
was not in one position long enough to develop pressure sores on his heels.
Petitioner relied on the testimony of Mr. Cortez (Tr. at 416, 418-419,
426, 440-442) that Resident 2, like all the residents at Brier Oak, was
on a two-hour "turning schedule," i.e., that Petitioner's staff turned
him so that a different part of his body was in contact with the bed every
two hours, and that Petitioner could ascertain from the direction a resident
was facing whether the resident had been turned on schedule. However,
I do not find this testimony persuasive. Mr. Cortez did not testify that
he had observed Resident 2 being turned, although he said he had observed
Resident 2 on his bed. Tr. at 318. The mere fact that Petitioner had a
policy to turn residents every two hours and that Petitioner should have
been able to ascertain by observing a resident whether the resident had
been turned on schedule does not establish that Resident 2 was in fact
regularly turned every two hours during the time period in question. In
any event, even if Petitioner had established that Resident 2 was turned
every two hours, Petitioner could not reasonably argue that this was sufficient
to prevent pressure sores since it is undisputed that Resident 2 developed
pressure sores on his left buttock. Petitioner also asserted that Resident
2 was not subject to unrelieved pressure long enough to cause pressure
sores because he was out of his bed twice daily for physical therapy sessions.
The record shows that Petitioner had "a.m." and "p.m." physical therapy
sessions (P. Ex. 1, at 115), but does not show whether they took place
at a time Resident 2 would otherwise have been in bed rather than in a
wheelchair, or the length of the sessions. Even if the sessions took place
during the 16 consecutive hours that the clinical record shows that Resident
2 was in bed, however, I conclude that Resident 2's heels were subject
to sufficient unrelieved pressure to cause pressure sores. Petitioner further argued that the blisters on Resident 2's heels were not pressure sores because their size and appearance were atypical for pressure sores. Petitioner cited Ms. Flemister's testimony that the blisters were small for pressure ulcers and that the area surrounding the blisters would be red or necrotic, rather than the pink initially noted by the nurse, if the blisters were pressure sores. Tr. at 493, 497-498.(3) However, the cited testimony does not support the argument
that the blisters were too small to be pressure sores since Ms. Flemister
admitted that a blister the size of the ones in question here could present
as a Stage II pressure sore. Tr. at 562-563. Moreover, both Professor
Stotts and Dr. Daniel testified based on their review of the clinical
record for Resident 2 that the blisters were pressure ulcers. Tr. at 154-155,
221. Further, none of the other witnesses indicated that the blisters
on Resident 2's heels could not be pressure ulcers based on the description
of the blisters in the clinical record. Indeed, Dr. Gura testified on
cross-examination that it was "difficult to tell" whether the description
of the blisters in the clinical record was consistent with a skin condition
brought about by persistent pressure. Tr. at 580. Dr. Brooks, who presumably
relied on a similar oral description in giving telephone treatment orders,
stated in a letter dated November 30, 1998 that he was "uncertain that
these blisters represented pressure related phenomena." P. Ex. 3, at 13.
Thus, not even Petitioner's other witnesses were in agreement with Ms.
Flemister's opinion that the blisters could not have been pressure ulcers
based on their appearance. Accordingly, I do not find Ms. Flemister's
testimony on this point credible. In support of its position that the blisters were not
pressure sores, Petitioner also relied on the testimony of Ms. Flemister
that, in her experience, "[e]very patient who has sensation in their heels
and gets pressure areas will complain at length about how badly it hurts"
(Tr. at 494) as well as the testimony of Dr. Gura that "if I have a .
. . pressure of that magnitude that is causing a blister, and I have my
sensory intact, that's going to hurt" (Tr. at 580). The record reflects
that Resident 2 consistently denied any pain or discomfort while at Brier
Oak. P. Ex. 1, at 159-162, 164-166. Notwithstanding this fact, Resident
2 had pressure sores on his left buttock. Petitioner did not offer any
explanation of why pressure sores on Resident 2's heels should have prompted
a complaint of pain when pressure sores elsewhere did not. Moreover, Professor
Stotts testified that not all pressure ulcers have pain with them. Tr.
at 133. Thus, I am not persuaded that the lack of pain or discomfort indicated
that the blisters were not pressure sores. Petitioner also disputed that the blisters were in a location
where pressure sores commonly occur. There is nothing in the record that
identifies the location of the blisters other than as on Resident 2's
heels. According to Petitioner, however, the blisters were not located
on the bony prominence of Petitioner's heels, where Petitioner admitted
pressure sores commonly occur, but were instead located further up, on
the Achilles' tendon. Petitioner relied on the testimony of Dr. Brooks,
Resident 2's physician, to that effect. Tr. at 384, 406. I do not find
this testimony credible, however. There is no evidence in the clinical
record for Resident 2 that indicates that Dr. Brooks ever saw the blisters.
The records reflect that the blisters were first noted by a nurse, who
advised Dr. Brooks of them and received telephone orders for their treatment.
P. Ex. 1, at 9, 166. Dr. Brooks made no record of seeing Resident 2 on
October 14 or 15, and the progress notes for his visit on October 16 do
not even mention the blisters. Id. at 48. Dr. Brooks' uncorroborated
testimony is also subject to question because he is Petitioner's medical
director (Tr. at 376) and thus has a personal and professional interest
in the outcome of this case. In addition, even assuming he saw the blisters,
the reliability of his memory of where they were located is questionable
since, when he testified, Dr. Brooks did not recall two salient facts
about Resident 2, i.e., that Resident 2 was incontinent and that Resident
2 had pressure sores on his left buttock. Tr. at 400, 404, 411. Petitioner's
position that the blisters noted to be on Resident 2's heels were located
instead on his Achilles tendons is also undermined by the testimony of
Dr. Daniel that the heel is conventionally considered to be below the
Achilles tendon, where the calcaneus bone begins. Tr. at 240-241. Dr.
Gura's testimony on this subject is inconclusive, since he testified that
he was told that the blisters in question were "higher than" the heel
but also that he had seen a nurse refer to the area around the Achilles
tendon as the heel. Tr. at 605, 611. Only Ms. Flemister testified unequivocally
that the heel does not have to be the bony prominence. Tr. at 565-566.
I conclude that the weight of the evidence establishes that the blisters
were located on the bony prominence of the heel. In any event, both Professor
Stotts and Dr. Daniel testified without contradiction that pressure sores
can appear elsewhere than on bony prominences. Tr. at 137, 235. Their
testimony to this effect is consistent with the statement in the AHCPR
guidelines that "[p]ressure ulcers usually occur over bony prominences."
P. Ex. 4, at 12 (emphasis added). Dr. Gura also admitted that if there
was pressure on the skin involving the Achilles tendon, a pressure ulcer
could develop there. Tr. at 584. Thus, the blisters could have been pressure
sores regardless of their location. Petitioner also argued that it had shown that the probable
cause of the blisters on Resident 2's heels was rubbing from his shoes
when he walked. P. Br. dated 8/25/00, at 18-19; P. Br. dated 11/1/00,
at 11-13. Petitioner relied on the testimony of Ms. Flemister that "it's
possible" that the cause of the blisters "could be friction from shoes,
or shoe gear . . . ." Tr. at 495. She noted that this cause would be consistent
with the fact that the blisters developed when the distance Resident 2
could walk in physical therapy had increased significantly. Tr. at 495-496.
However, Ms. Flemister was clearly just speculating as to the cause of
the blisters, prefacing the remarks quoted above by saying that "[t]his
is one of those that you know what it's not, but you can't really be sure
of what it is because I wasn't there." Tr. at 495. There is nothing else
in the record that supports the theory that the blisters were caused by
rubbing shoes. Petitioner pointed to testimony that Resident 2 wore his
"street clothes," including shoes, when he was out of bed (Tr. at 314,
317); however, this testimony has no probative value absent a showing
of some connection with the blisters, e.g., that the shoes did not fit
properly and that the blisters were located where the shoes would have
rubbed. Indeed, although Dr. Brooks was kept informed of Resident 2's
progress in physical therapy (P. Ex. 1, at 47-48) and thus would presumably
have known the extent to which he was ambulatory, Dr. Brooks never suggested
rubbing shoes as the cause of the blisters. Instead, Dr. Brooks stated
in support of Petitioner's motion for summary judgment that, in his opinion,
the blisters on Resident 2's heels "were not caused by pressure but in
fact were a product of his medical condition," for example, a result of
venous insufficiency. Declaration of Lawrence Brooks dated 3/24/00, at
1-2. Similarly, at the hearing, Dr. Brooks suggested only that some aspect
of Resident's medical condition was the cause of the blisters. Tr. at
410-411. Accordingly, I conclude that there is no credible evidence that
the blisters on Resident 2's heels were caused by rubbing shoes.(4)
(Since Petitioner argued in its post-hearing briefs only that the probable
cause of the blisters was rubbing shoes, I do not consider its earlier
arguments regarding other possible causes of the blisters.) Finally, although Petitioner did not dispute that the
treatment for the blisters ordered by Dr. Brooks was consistent with a
diagnosis of pressure ulcers, Petitioner argued that "[c]ommon sense reveals
that . . . such a treatment is not limited to pressure sores." P. Br.
dated 11/1/00, at 9. In light of Petitioner's failure to provide credible
evidence that the probable cause of the blisters was something other than
unrelieved pressure, however, it is irrelevant whether the treatment was
also appropriate for skin lesions other than pressure sores. Accordingly, I conclude that the blisters on Resident 2's heels were pressure sores within the meaning of 42 C.F.R. § 483.25(c). In reaching this conclusion, I am not second-guessing any contrary judgment by Resident 2's physician or by the nurses at Brier Oak who noted the blisters and treated them. As discussed above, although the blisters were not specifically identified as pressure sores, the treatment orders given by Dr. Brooks and carried out by the nurses were consistent with a diagnosis of pressure sores. Furthermore, the fact that Dr. Brooks ordered heel protectors as soon as the blisters were noted indicates that he viewed the blisters as pressure sores. Moreover, Petitioner's plan of care for Resident 2 clearly reflected a judgment that the blisters involved skin breakdown attributable to pressure. Thus, my conclusion reflects Petitioner's health care professionals' contemporaneous diagnosis of the blisters.(5) The pressure sores on Resident 2's heels were
not unavoidable. A finding that Resident 2 developed pressure sores on
his heels while at Brier Oak does not, standing alone, mean that Petitioner
was out of compliance with 42 C.F.R. § 483.25(c). Instead, under that
provision, there is no deficiency if "the individual's clinical condition
demonstrates that [the pressure sores] were unavoidable." As noted above,
Petitioner has the burden of proving that the clinical condition demonstrates
this. I conclude that Petitioner has not met its burden of proof. As discussed earlier, the applicable standard is that
a facility should "always furnish what is necessary to prevent new sores
unless clinically unavoidable. . . ." DAB No. 1750, at 32.(6)
Both Professor Stotts and Dr. Daniel testified that preventive measures
for pressure sores include use of some form of heel protection. Tr. at
153-154, 157, 178-182, 216-217, and 224. These witnesses also indicated
that it was appropriate to institute this preventive measure immediately
for any individual at high risk of developing pressure sores. In addition,
the AHCPR guidelines recommend "the use of devices that totally relieve
pressure on the heels" to prevent pressure sores in certain high-risk
individuals. P. Ex. 4, at 19. Indeed, Petitioner admitted that it used
heel protectors for immobile residents during the time in question. There
is no dispute that Petitioner did not use any form of heel protection
for Resident 2 until after pressure sores developed on his heels. Since
Petitioner did not employ an accepted preventive measure for an individual
at high risk for developing pressure sores, I conclude that Petitioner
did not do what was necessary to prevent new sores. Thus, Petitioner cannot
reasonably claim that Resident 2's clinical condition demonstrates that
the pressure sores were unavoidable. Petitioner nevertheless argued that there was no scientific
basis for finding that heel protectors were necessary to prevent pressure
sores from developing on Resident 2's heels. Petitioner appeared to use
"heel protectors" to refer to a boot-type device. Petitioner cited the
testimony of Ms. Flemister that her research had disclosed no studies
showing the effectiveness of heel protectors in preventing pressure sores
(Tr. at 560, 568). The lack of such studies is not dispositive, however.
First and foremost, the fact that Petitioner's plan of care for Resident
2 indicated that heel protectors should be used to prevent skin breakdown
and that Petitioner used heel protectors for certain other residents during
the time in question here is evidence that Petitioner believed heel protectors
to be effective. In addition, Ms. Flemister acknowledged that "in the
generally accepted authorities . . . heel protectors or pillows to suspend
heels is a recommended intervention." Tr. at 560-561 (affirmative response
to counsel's question whether this was true). Moreover, Petitioner appeared
to be arguing only that the use of heel protectors rather than another
form of heel protection was not scientifically supported. Neither Professor
Stotts nor Dr. Daniel took the position that any particular form of heel
protection was required here, however. Petitioner also argued that it followed from the fact
that the AHCPR guidelines recommend the use of devices that relieve pressure
on the heels to prevent pressure sores in "[i]ndividuals in bed who are
completely immobile" that such devices were not appropriate for Resident
2. However, I do not read the guidelines as implying that some form of
heel protection is not an appropriate preventive measure for individuals
other than those who are completely immobile. Indeed, Ms. Flemister, as
well as Professor Stotts and Dr. Daniel, testified that the guidelines
do not preclude the use of heel protection for other individuals. Tr.
at 159-160, 251, 561. Petitioner further argued that it need not have provided
some form of heel protection for Resident 2 because Resident 2 did not
have a specific risk for pressure sores on his heels. According to Petitioner,
such a risk did not exist because Resident 2 would have moved his legs
in order to relieve pressure on his heels. As discussed above, however,
Resident 2's ability to move was not sufficient to enable him to reposition
himself in bed so as to relieve pressure. Petitioner also cited the fact
that Resident 2 was in his wheelchair on a daily basis and participated
in physical therapy twice a day. As also discussed above, however, Resident
2 was still subject to sufficient unrelieved pressure on his heels to
cause pressure sores. Thus, there was no reason for Petitioner not to
take whatever measures were necessary to prevent the development of pressure
sores on Resident 2's heels, including the use of some form of heel protection. Petitioner also argued that the use of any form of heel
protection for Resident 2 "would be inappropriate for his quality of life
. . . ." P. Br. dated 11/1/00, at 31. Petitioner cited the testimony of
Ms. Flemister that heel protectors are extremely hot and are difficult
to keep in place without pulling the strap so tight that it sometimes
causes injury to the top of the foot. Tr. at 519, 521. In addition, Petitioner
cited Ms. Flemister's testimony to the effect that positioning pillows
to relieve pressure on the heels causes discomfort to an individual with
the ability to move his lower extremities in bed because the individual
needs to remain still in order to keep the pillows from becoming dislodged.
Tr. at 523.(7) Ms. Flemister admitted that
her observations were based solely on her own experience. Tr. at 518.
Even if her experience were typical, however, the fact remains that some
form of heel protection is an accepted preventive measure for individuals
at high risk of developing pressure sores. Accordingly, in requiring that
a facility do what is necessary to ensure that pressure sores do not develop,
the regulations did not give Petitioner leeway to determine that any drawbacks
of heel protection devices outweighed the risk that Resident 2 would develop
pressure sores. A civil money penalty of $500 per day was reasonable. HCFA imposed a civil money penalty of $500 per day for the period November 19, 1998 to January 22, 1999. Pursuant to 42 C.F.R. § 488.438(a)(2), HCFA was authorized to impose a penalty in the range of $50 - $3000 per day for the deficiency in question here, which HCFA determined caused no actual harm but had the potential for more than minimal harm but not immediate jeopardy.(8) Petitioner took the position that the amount of the civil
money penalty, which it noted was 10 times the minimum allowable amount,
was unreasonable for a case involving a single deficiency. In response,
HCFA argued that the amount imposed was not excessive since Brier Oak
had "an unbroken history of noncompliance with the very requirement at
issue herein." HCFA Br. dated 11/1/00, at 36. Petitioner was found in
violation of 42 C.F.R. § 483.25(c) in the annual surveys on May 1997 and
May 1998 in addition to the November 1998 complaint survey at issue here.
Pursuant to 42 C.F.R. § 488.438(f)(1), Brier Oak's "history of non-compliance,
including repeated deficiencies," is a factor be considered in setting
the amount of the penalty. Petitioner stated, however, that HCFA did not show that
the prior deficiencies involved the same factual circumstances as the
current deficiency, i.e., that they related to the prevention rather than
the treatment of pressure sores. To the extent that this constitutes an
argument that the current deficiency was not a repeated deficiency within
the meaning of § 488.438(f)(1), this argument has no merit. Section 488.438(d)(3)
as in effect during the time in question defined the term "repeated deficiencies"as
"deficiencies in the same regulatory grouping of requirements found at
the last survey, subsequently corrected, and found again at the next survey."
Although § 483.25(c) has separate provisions addressing the prevention
and treatment of pressure sores, these provisions are obviously "in the
same regulatory grouping of requirements." In any event, under § 488.438(f)(1),
a history of non-compliance is a factor to be considered in setting the
amount of the penalty even if it does not involve repeated deficiencies. HCFA also took the position that a $500 per day civil
money penalty was justified in part due to Petitioner's culpability with
respect to Resident 2. Section 488.438(f)(4) defines "culpability" as
including "neglect, indifference, or disregard for resident care, comfort
or safety." HCFA asserted that "Petitioner's failure to perform an adequate
risk assessment when this very ill resident was first admitted and the
subsequent indifference to his vulnerability to pressure ulcers constitute
clear evidence of culpability." HCFA Br. dated 11/1/00, at 37. Petitioner
denied that it was culpable, asserting that it assessed Resident 2 appropriately
and did everything that was reasonably necessary to prevent the development
of pressure sores. Petitioner acknowledged that the initial assessment it
performed when Resident 2 was admitted to Brier Oak did not reflect his
high risk of developing pressure sores, but argued that it properly relied
on the hospital Transfer Summary when it performed the initial assessment,
and also that its subsequent assessments correctly reflected Resident
2's condition. P. Br. dated 8/25/00, at 20-23; P. Br. dated 11/1/00, at
25-27. I need not consider the initial assessment in determining the degree
of Petitioner's culpability since Petitioner was highly culpable based
solely on Petitioner's failure to provide some form of heel protection
for Resident 2. Petitioner's failure to take this accepted preventive
measure for a resident at high risk for pressure sores demonstrates a
serious disregard for Resident 2's care, comfort, and safety. Petitioner did not address any of the other regulatory
factors for determining the amount of a civil money penalty to support
its position that the amount of the penalty was unreasonable. Accordingly, I conclude that a civil money penalty of $500 per day is reasonable. While this amount is greater than the minimum penalty amount which may be imposed under § 488.438(a)(2), it is still on the low end of the range of penalty amounts. In light of Petitioner's history of repeated deficiencies, its culpability with respect to Resident 2, and the fact that Petitioner did not provide any evidence of an inability to pay the penalty, which totals $32,000, a penalty in this amount is warranted to motivate Petitioner to maintain substantial compliance with the requirements pertaining to the prevention and treatment of pressure sores. |
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| JUDGE | |
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Marion T. Silva Chief Administrative Law Judge
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| FOOTNOTES | |
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1. HCFA objected to the admission of parts of Petitioner's Exhibit 11, the Declaration of Robert Cortez. Petitioner agreed to withdraw paragraphs 13, 15, 16, and 17 as well as lines 8 through 10 on page 3 of the declaration (page 4 of Exhibit 11), but maintained that lines 2 through 7 should be admitted on the ground that Mr. Cortez's opinion regarding the records taken by the surveyor was relevant to Petitioner's contention that the investigation leading to the deficiency finding was incomplete. HCFA took the position that Mr. Cortez was not competent to render such an opinion. Tr. at 612-615. I admit the lines in question since they relate to an issue raised by Petitioner. However, as discussed later, this issue has no bearing on the result in this case. 2. I find that HCFA made a prima facie case that the blisters on Petitioner's heels were pressure ulcers. As noted above, in order to do so, HCFA needed only to provide evidence that, if unrebutted, would support such a conclusion. Here, I find that such a conclusion is supported by a preponderance of the evidence. 3. Petitioner argued that Ms. Flemister's testimony about the color of the skin surrounding a pressure sore that presents as a blister is corroborated by the testimony of Professor Stotts and Dr. Daniel that pressure sores that develop into blisters usually start out with redness (Tr. at 137-138, 198-199). However, their testimony indicates that the area of redness develops into a blister, not that the skin around the blister is red. (Furthermore, the Statement of Deficiencies states that the September 22, 1998 Nurses Weekly Skin and Wound Progress Record for Resident 2 indicated that "the resident was assessed as having a stage (1) red, right heel pressure area, which measured 8 x 7 cm. with a pink surrounding area." HCFA Ex. 1, at 7 (emphasis added). However, the September 22, 1998 document is not in the record before me.) 4. Although HCFA elsewhere indicated that an ulcer caused by friction can be considered a pressure ulcer (HCFA Ex. 7, at 1 ("Guidance to Surveyors")), and Professor Stotts testified to this effect (Tr. at 188), HCFA did not argue here that the blisters on Resident 2's heels were pressure ulcers even if they were caused by friction from rubbing shoes. Accordingly, for purposes of this case, I use the more limited definition of a pressure ulcer in FFCL 2. 5. Petitioner argued that the fact that Petitioner's nursing staff did not assign Resident 2's blisters a stage indicated that they did not believe the blisters to be pressure ulcers. However, there were several instances where Petitioner failed to adequately document Resident 2's condition or the care provided him. See, e.g., Tr. at 218 (failure to document daily skin checks), 394-396 (Resident 2's condition not reflected on history and physical). Under these circumstances, the absence of staging is not a clear indication of how Petitioner's nursing staff viewed the blisters. 6. Petitioner took the position that "a facility must establish that it provided the care that was reasonably necessary to prevent the formation of pressure sores." P. Br. dated 8/25/00, at 19 (emphasis in original). To the extent that this differs from the standard articulated above, I conclude that Petitioner applied the incorrect standard. 7. Petitioner also stated that Dr. Gura had testified that placing pillows under the calves can "lead to thrombosis and other problems in the legs." P. Br. dated 8/25/00, at 32, citing Tr. at 588-589. However, Dr. Gura testified only that circulation problems could result in the case of an individual who was immobile and whose position was not changed from time to time. 8. Petitioner correctly observed that the regulations authorize but do not require HCFA to impose any civil money penalty here given the level and scope of Petitioner's non-compliance. See 42 C.F.R. § 488.408(d)(3). However, this has no bearing on the reasonableness of the amount of a penalty which HCFA has exercised its discretion to impose. Petitioner also noted that HCFA has authority to impose a "per instance" civil money penalty not exceeding $10,000. However, the regulatory provision that authorizes this--42 C.F.R. § 488.438(a)(2)--was not issued until after HCFA imposed the per diem civil money penalty at issue here. See 64 Fed. Reg. 13354 (March 18, 1999). Moreover, the preamble to the final regulations indicates that the per instance penalty was intended to give HCFA another enforcement option, not that it was intended as a substitute for the per diem penalty in particular types of cases. Id. at 13356. | |