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Department of Health and Human Services DEPARTMENTAL APPEALS BOARD Civil Remedies Division |
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Sunbridge Care and Rehabilitation for Escondido East, |
DATE: April 17, 2002 |
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Centers for Medicare & Medicaid Services
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Docket No.C-00-632
Decision No. CR891 |
| DECISION | |
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DECISION I set aside as without basis
the determination of the Centers for Medicare & Medicaid Services
(CMS) (this agency was formerly named the Health Care Financing Administration)
to impose remedies against Petitioner, Sunbridge Care and Rehabilitation
for Escondido East (Petitioner, Sunbridge, or facility), for its alleged
failure to substantially comply with federal requirements governing participation
of long-term care facilities in Medicare and State Medicaid programs.
The remedies CMS sought to impose were: a civil money penalty (CMP) of
$50 per day, for 36 days from May 19, 2000 through June 24, 2000, followed
by termination of the provider agreement on June 24, 2000. I. Background This case came before me
pursuant to a request for hearing filed by Petitioner on June 27, 2000.
The request was filed in accordance with section 1128A(c)(2) of the Social
Security Act (Act) and 42 C.F.R. §§ 488.408(g) and 498.40. The request
stems from two revisit surveys conducted at Sunbridge by the California
State survey agency. One survey ended on May 19, 2000, and the other ended
on June 15, 2000. The facility was cited under five different f-tags
(1) for allegations that the care of six residents was found
to be deficient over the course of the two surveys. In the introduction to Petitioner's
request for a hearing, Petitioner described the background of its request
as "convoluted." I agree with that assessment, and I feel that it is useful
to clear through some of the extraneous information, and the tangle of
arguments I do not consider in this case, in order to clarify what is
at issue in the case. The remedies that are the
subject of this decision are the $50 per day CMP imposed pursuant to the
May and June 2000 surveys, and the termination (2)
of the facility's Medicare and Medicaid provider agreement on June 24,
2000, following the June survey. Several issues raised by the parties
have become moot in light of my findings and conclusions which I have
made based on the totality of the evidence in this case. Nonetheless,
the inclusion of these issues in the prehearing proceedings, at the hearing,
and in the post-hearing briefing constitutes a considerable portion of
the case. Since these issues may lend to the erroneous impression that
the CMP I should consider includes the period from February 3, 2000 to
May 19, 2000 (as argued by Petitioner), and because the volume of the
record absorbed by them may generally cause confusion, I address them
briefly now. [These extraneous issues (and my conclusions concerning them)
are: (1) the so-called "sixth month rule" issue is moot; (2) the CMP assessed
from February 3, 2000 through May 19, 2000 at $50 per day is not before
me; (3) the argument that immediate jeopardy must be present before CMS
may terminate a provider agreement is moot; and (4) Petitioner's motion
for summary disposition made at the hearing is moot.]
The facts which form the
basis of this contention are that CMS sent conflicting notices following
the February 3, 2000 survey. The first notice dated April 11, 2000, informed
the facility that it was found in substantial compliance based on the
February 3, 2000 revisit survey. Then, by notice dated May 11, 2000, CMS
informed the facility that the April 11, 2000 notice had been sent in
error, and that, in fact, further instances of deficiencies had been discovered
during the February 3, 2000 survey. From the facts surrounding these two
notices, putatively raised by Petitioner to argue the "sixth month rule,"
Petitioner appended the argument that the CMP in dispute in this case
should include, in addition to the remedies imposed pursuant to the May
and June 2000 surveys, the $50 per day CMP assessed based on the deficiencies
found at the February 3, 2000 survey. Despite Petitioner's contention,
after reviewing the record, I conclude that the CMP assessed from February
3, 2000 through May 19, 2000 at $50 per day is not before me. I come to
this conclusion because during the proceedings the issues were limited
to the deficiencies alleged stemming from the May and June 2000 surveys,
and because Petitioner did not appeal the May 11, 2000 notice which identified
the CMP and afforded Petitioner an opportunity to appeal the deficiencies
therein. First, a review of what
the parties argued concerning this disputed period of CMP is in order.
Then I explain my determination that it is not an issue before me. In the request for a hearing
(the same request where Petitioner sought to explain what it termed the
"convoluted" background of the request for a hearing), I note that, on
page 2, Petitioner discussed the April 11, 2000 notice purporting to lift
the denial of payment for new admissions and the May 11, 2000 notice indicating
the revocation of the April 11 notice. But nowhere in the request does
Petitioner specifically indicate it is challenging the CMP prior to May
19, 2000. Along with its request for
hearing, Petitioner filed Petitioner's Emergency Motion for Expedited
Hearing or in the Alternative for a Stay Pending the Hearing. This emergency
motion also touches on the two notices, and it also includes mention of
the notices to support its contention that the "sixth month rule" was
misapplied. The motion, however, does not explicitly contend there is
no basis for the imposition of a CMP prior to the May survey. Although,
implicit in Petitioner's argument that the April 11, 2000 notice cannot
be undone by the May 11, 2000 notice for the purpose of reinstating a
six- month period of noncompliance, is the assumption that the April 11,
2000 notice stands, and therefore, arguably, there is no basis for a CMP
since that notice found the facility in compliance. As explained more
fully below, I find this insufficient to preserve the CMP from the February
3, 2000 survey as an issue in this case. Petitioner participated
in limiting the issues in this case, ahead of the hearing, to those issues
arising from the May and June surveys (I might have found evidence concerning
the conflicting notices and the "sixth month rule" relevant insofar as
that evidence affected the remedies from the May and June surveys). I
held a prehearing telephone conference on October 17, 2000 , to discuss
further delineating the issues for hearing, because, not surprisingly,
there was confusion. The upshot of the prehearing conference was that
I ordered the parties to submit final statements of the issues before
the hearing. Petitioner submitted its statement in a letter dated November
6, 2000. In its letter, Petitioner framed the issues this way: "If SunBridge
demonstrates that it was in substantial compliance with applicable regulations
at the time of these surveys [May and June 2000], then any other remedies
HCFA imposed for any date on which SunBridge demonstrates that it was
in substantial compliance (denial of payment for new admissions and civil
monetary penalty) necessarily will fall as well." It seemed clear enough
that the scope of the hearing was limited to the May and June surveys,
and no other survey prior or afterwards. While our prehearing conference
call, as Petitioner's letter confirms, limited the issues in the case,
regrettably, there was an exchange at the hearing which seemingly resuscitated
the question of the February 3 - May 19, 2000 CMP because the parties
addressed whether it was in issue. Transcript of hearing (Tr.) at 601-611.
I asked the parties to brief the issue, and they agreed to handle it that
way. Tr. at 610-611. Neither party discussed in that exchange that we
had delineated the issues during the pre-hearing conference and follow-up
filings. Instead, Petitioner referred back to its original request for
a hearing. CMS argued at length in
its initial posthearing brief (the parties simultaneously filed posthearing
briefs and reply briefs) that the CMP from February 3, 2000 to May 19,
2000 is not at issue. CMS' Brief, at 60-64. However, despite the agreement
of the parties at hearing to brief the issue, it is not clear from Petitioner's
posthearing submissions whether it wished to press the issue or not. In
its initial posthearing brief, Petitioner argues that I should set aside
the termination because Petitioner was in compliance at both the May and
June surveys. Petitioner's Brief at 2. As I have indicated, Petitioner
argued that CMS cannot use the "sixth month rule" as a basis for termination.
Petitioner's Brief, at 4-11. Petitioner also argued that CMS cannot terminate
the facility's provider agreement without a finding of a deficiency at
the immediate jeopardy level. Petitioner's Brief at 42-50. Petitioner
concluded its brief "[f]or the reasons set forth above, the ALJ should
set aside HCFA's termination action." Petitioner's Brief, at 51. Petitioner
concluded its reply brief with "[f]or the reasons set forth at the hearing,
in SunBridge's Principal Brief, and above, SunBridge requests that the
ALJ set aside HCFA's termination action and find that SunBridge was in
compliance with all applicable regulatory requirements at all pertinent
times." Petitioner's Reply Brief, at 23. Those are the major arguments
that Petitioner asserts in its brief, and there are no further arguments
in Petitioner's briefs concerning the CMP imposed for February 3, 2000
through May 19, 2000. Noting this absence, CMS concludes that Petitioner
has abandoned its position on this point. CMS' Reply Brief, at 27. Somewhat mysteriously, while
absent from its briefs, in its Proposed Findings of Fact and Conclusions
of law of Petitioner Sunrise Care and Rehabilitation for Escondido East
(filed simultaneously with its initial posthearing brief), Petitioner
proposed I adopt the conclusion that "[i]n addition, HCFA's imposition
of a $50 per day civil monetary penalty for the period February 3, 2000
and following has no regulatory basis and accordingly is set aside." Petitioner's
Proposed Findings of Fact and Conclusions of Law at 32. Additionally,
Petitioner proposed that I adopt a conclusion of law that "HCFA also lacked
the authority to impose a CMP for a period for which it previously had
certified compliance." Petitioner's Proposed Findings of Fact and Conclusions
of Law at 27. Thus, while it is not really clear whether Petitioner meant
to elaborate on its basic assertion that my findings should include a
finding in its favor on the CMP assessed pursuant to the February 3, 2000
survey, Petitioner's off and on approach is enough for me to address it
as a preliminary matter. First, as noted by CMS
in its brief at page 4, fn 4, the May 11, 2000 notice purporting to withdraw
the April 11, 2000 notice apprised Petitioner of its right to appeal.
Thus, there was notice and opportunity for Petitioner to preserve the
question of the CMP stemming from the February survey, despite the controversy
of whether CMS can send a notice certifying compliance and then follow
it with another notice reversing the previous notice's determination due
to what CMS deems a "mistake." Second, to the extent Petitioner
might argue that by raising the controversy over the effect of the April
11, 2000 notice and the May 11, 2000 notice to support its "sixth month
rule" argument, the question of the CMP was preserved, I find that it
was waived by the limiting of the issues, with Petitioner's participation,
to those arising from the May and June surveys. My impression is strengthened
by Petitioner's silence on the question in the body of its posthearing
brief and reply brief. Accordingly, I will not consider the appropriateness
of any CMP imposed prior to the May and June 2000 surveys.
Therefore, the remedies I address in this decision are limited to a CMP of $50 per day for 36 days, from May 19, 2000 through June 24, 2000, followed by termination of the provider agreement on June 24, 2000.
I presided at a hearing
of this case in San Diego, California from November 14 through November
17, 2000. CMS was represented by Robert A. Jackson, Esq. and Anne Hall,
Esq., and Petitioner was represented by Joseph L. Bianculli, Esq. At the hearing, CMS offered
27 exhibits (3) which I admitted into evidence
as HCFA Exhibits 1-27 (HCFA Ex. 1-27). Petitioner offered 125 exhibits
which I admitted into evidence as Petitioner's Exhibits 1-125 (P. Exs.
1-125). II. Applicable Law
and Regulations Petitioner is considered
a long-term care facility under the Act and the regulations promulgated
by the United States Secretary of Health and Human Services (Secretary).
The statutory requirements for participation by a long-term care facility
are found at sections 1819 and 1919 of the Act, and at Title 42 C.F.R.
Parts 483, 488, and 498. Sections 1819 and 1919 of
the Act invest the Secretary with authority to impose CMPs against a long-term
care facility for failure to substantially comply with participation requirements. Pursuant to the Act, the
Secretary has delegated to CMS and the States the authority to impose
remedies against a long-term care facility that is not substantially complying
with federal participation requirements. 42 C.F.R. Part 483 provides that
facilities which participate in Medicare may be surveyed on behalf of
CMS by State survey agencies in order to ascertain whether the facilities
are complying with participation requirements. 42 C.F.R. §§ 488.10-488.28.
The regulations contain special survey conditions for long-term care facilities.
42 C.F.R. §§ 488.300-488.335. Under Part 488, CMS may impose a CMP against
a long-term care facility where a State survey agency ascertains that
the facility is not complying substantially with participation requirements.
42 C.F.R. §§ 488.406, 488.408, 488.430. The penalty may start accruing
as early as the date that the facility was first out of compliance and
remain in effect until the date substantial compliance is achieved or
the provider agreement is terminated. 42 C.F.R. § 488.440. The regulations specify
that a CMP that is imposed against a facility will fall into one of two
ranges of penalties. 42 C.F.R. §§ 488.408, 488.438. The upper range of
CMPs, of from $3,050 per day to $10,000 per day, is reserved for deficiencies
that constitute immediate jeopardy to a facility's residents, and, in
some circumstances, for repeated deficiencies. 42 C.F.R. §§ 488.438(a)(1),
(d)(2). The lower range of CMPs, of from $50 per day to $3,000 per day,
is reserved for deficiencies that do not constitute immediate jeopardy,
but either cause actual harm to residents or cause no actual harm but
have the potential for causing more than minimal harm. 42 C.F.R. § 488.438(a)(2). "Substantial compliance" is defined as:
In a CMP case, CMS must
make a prima facie case that the facility has failed to comply substantially
with participation requirements. To prevail, a long-term care facility
must overcome CMS' showing by a preponderance of the evidence. Hillman
Rehabilitation Center, DAB No. 1611 (1997); aff'd,
Hillman Rehabilitation Center
v. DHHS, No. 98-3789(GEB), slip op. (D.N.J. May 13, 1999). The Act and regulations
make a hearing available to a long-term care facility against whom CMS
has determined to impose a CMP. Hearings are before an Administrative
Law Judge (ALJ) of the Departmental Appeals Board (DAB). Act, section
1128A(c)(2); 42 C.F.R. §§ 488.408(g), 498.3(b)(13). A hearing before an
ALJ is a de novo proceeding.
Anesthesiologists Affiliated
et al, DAB CR65 (1990), aff'd,
941 F.2d 678 (8th Cir. 1991).
III. Issues The issue is whether the facility was complying substantially with the following federal requirements during the May and June, 2000 surveys as cited by the California State survey agency:
IV.
Findings and Discussion My conclusions of law and findings of fact, which are cited below in italics, are followed by my analysis and discussion.
At tag F280-D, the May survey report (Form 2567) alleges that Petitioner did not comply substantially with the requirements of 42 C.F.R. § 483.20, that, for each resident, a comprehensive care plan must be--
HCFA Ex. 1,
at 1-7; 42 C.F.R. § 483.20(k)(2). (4) The alleged
deficiency was based on the development of a black blister on the left
heel of Resident 34 (R34) on or around May 12, 2000. The facility had
observed the resident's heels to be reddened and "mushy" in January and
February, and CMS argued that Petitioner failed to monitor the resident's
heels, failed to develop a care plan to assess the heels, and used inappropriate
treatment to treat her heels prior to the development of the black blister
in May. Tr. at 51, 58-59, 62-72. The allegation was not based on failure
to treat the blister on the resident's heel, and CMS' expert witness testified
that the facility appropriately monitored the blister once it developed.
Tr. at 154. A CMS determination
that a petitioner is not in substantial compliance with the applicable
standards of participation is based on the deficiencies alleged in the
Form 2567 that CMS issues to the provider pursuant to the notice requirements
of 42 CFR § 498.20. See,
e.g., Cross
Creek Health Care Center, DAB No. 1665 (1998). I thus look to the
Form 2567 in determining whether CMS has made its prima facie case of
noncompliance, and, if so, whether Petitioner has shown by a preponderance
of the evidence that it was in substantial compliance with the relevant
conditions of participation. The Form 2567
summarizes the findings under this f-tag as follows:
HCFA Ex. 1,
at 2, 6-7. The Form 2567
also noted the following in support of the alleged deficiency:
HCFA Ex. 1,
at 3-6. At the time
of her admission in August 1999, the resident was a 91-year-old woman
with multiple diagnoses including chronic obstructive pulmonary disease
(COPD), congestive heart failure, diabetes mellitus, and Alzheimer's disease.
Her feet were noted to be cool with absent pulses and venous stasis changes.
She was determined to be at moderate risk for the development of pressure
sores. The facility described the resident's heels as reddened and "mushy"
on a change of condition form completed on January 12, 2000 and on a nurse's
note from the following day. HCFA Ex. 1, at 3-4. At that time, the resident's
attending physician prescribed treatment of the heels with "skin prep."
P. Ex. 18, at 4. A nurse's note two days later described the heels as
reddened, with no open areas. HCFA Ex. 1, at 4. The Form 2567 states that
there was no further documentation regarding the resident's heels for
approximately six weeks, when a weekly summary dated February 24 stated
that both heels continued to be mushy. An undated change of condition
form that was found in the resident's record on a weekly summary dated
May 12, 2000, reported the presence of a small black blister that was
3 x 4 cm in size with an open area that was 0.5 x 0.1 cm. HCFA Ex. 5,
at 105. The State surveyor testified that on May 18, she measured the
blister to be 2.7 x 3.2 cm, with the open area 1.0 x 1.4 cm. It was not
disputed that the blister healed with treatment. The essence
of this deficiency finding was that Petitioner failed to develop a care
plan for the resident's heels, once they were noted to reddened and mushy.
Tr. at 66-67, 174. With respect to the care plan requirement in section
483.20(k)(2), CMS may have established a prima facie case of a deficiency
based on the condition of the resident's heels noted in February, the
apparent absence of a care plan for the treatment of the resident's heels,
and the subsequent development of the black blister on the resident's
heel in May. However, Petitioner, by a preponderance of the evidence,
established that it had in place a care plan which encompassed the resident's
mushy, reddened heels, and thus, was in compliance with this requirement
of participation. CMS' determination
that Petitioner did not have a care plan in place for treatment of the
resident's heels was based on the report of a State surveyor who conducted
the May survey that such a care plan was not among the medical records
for the resident that she examined, and that Petitioner's staff did not
produce a care plan in response to her request for all relevant care plans
relating to the resident's heels. Tr. at 109-110. However, I find that
the facility did have a care plan in place, identified as "non-pressure
ulcer impaired skin integrity," which encompassed the resident's heels.
P. Ex. 17, at 1-4. Although this care plan was apparently not provided
to the State surveyor during the survey, it was among the materials that
the facility presented to the State survey agency for the purposes of
the Informal Dispute Resolution (IDR) that was convened shortly after
the May survey. The care plan, which has entries ranging from November
1999 through June 2000, indicates that the resident's heels were observed
on January 12, 2000, that it was recommended that her heels be kept elevated
off the mattress when she was in bed, and that her heels be treated with
"skin prep" as ordered by the resident's attending physician. Id. CMS objected
to the admission of the care plan on the grounds that it may have been
altered or fabricated after the date of the survey, and questioned its
relevance for demonstrating compliance under the Departmental Appeals
Board's holding in Hillman Rehabilitation
Center, supra.
Neither argument justifies disregarding the care plan in this case. Petitioner's
witness, Ms. Laird, a registered nurse and Petitioner's clinical services
coordinator for the San Diego region, testified that she recalled seeing
the care plan referenced among a list of materials that she helped the
facility prepare for IDR within days after the May survey, and that she
had no knowledge it had been created after-the-fact for the purpose of
responding to the survey. Tr. at 865-66. Based on her demeanor, I found
Ms. Laird to be a credible witness, and I deem Petitioner's exhibit 17
to be a reliable component of the record. (5)
While the State surveyor was also a credible witness, her testimony that
a nurse whose name appears on the care plan in January did not recall
having prepared it when interviewed during the survey in May is not inconsistent
with this finding. That interview was conducted some four months after
that nurse's entry in the care plan, and the nurse was apparently agitated
during the interview by discussions concerning whether she had deviated
from the care plan and physician's order regarding the feeding of another
resident, which discussions apparently caused her to "break into tears."
Tr. at 335, 711-12. CMS has not demonstrated that the care plan was fabricated
or otherwise created after the date of the survey. CMS cited the
DAB decision in Hillman
for the proposition that documentary evidence such as the care plan may
only be considered if Petitioner can meet what CMS characterized as a
"very heavy burden" of showing that it was readily available at the time
of the survey but was not produced due to the inadequacy of the surveyor's
request. CMS' Reply Brief, at 9. However, Hillman
addressed very different circumstances and does not require rejection
of the care plan here. For one, the
decision in Hillman to
exclude the proffered exhibits was made in the face of what the DAB characterized
as intrinsic evidence of the unreliability of those exhibits for the purposes
for which they were offered. Hillman,
at 25. For example, the physician's signatures on the disputed records
in Hillman included dates
that were well after the date of the survey and the dates on which the
physician's services were said to have been provided. Id.
at 40-41. There are no such inconsistencies apparent on the face of the
care plan here. In Hillman
the DAB also noted that the ALJ, in assigning relevance to the disputed
records, did not make assessments of the credibility of relevant witnesses
based on their demeanor, but rather on factual findings and inferences
which were not supported by substantial evidence in the record, and ignored
other relevant facts. Id.
at 45. Here, by contrast, I have considered the demeanor of Ms. Laird,
Petitioner's witness, who testified regarding the disputed care plan,
and I find her testimony to be credible. CMS offered no evidence to support
its claim that the care plan may have been fabricated beyond the testimony
of the State surveyor, which I found to be fully reconcilable with my
finding that the facility did indeed develop a care plan which encompassed
the resident's heels. In Hillman
the DAB found that CMS' attack on the credibility of the disputed records
was supported by the facility's failure to produce them some six weeks
after the survey when it submitted its plan of correction, and the facility's
ongoing failure to maintain current clinical records in a central office
despite its assurances to the surveyors that they would do so. Id.
at 32-33; Hillman Rehabilitation
Center, DAB No. 1663 (1998) (decision following remand). Here,
the evidence indicates that Petitioner made the care plan available shortly
after the survey, when it submitted materials to the State survey agency
as part of the IDR process. The essence
of the holding in Hillman
is that a petitioner may not rely on evidence that: 1) it generated after
the survey was completed; or, 2) was not available at the time of the
survey to demonstrate compliance. Neither of these circumstances pertain
to Petitioner's plan of care for R34's heels. The DAB has held that the
dispositive date for assessing whether a facility is out of compliance
is the date of the survey from which its termination resulted. Carmel
Convalescent Hospital, DAB No. 1584, at 12 (1996). Petitioner here
provided reliable, credible evidence that a care plan which encompassed
the resident's heels existed prior to the date of the survey, and the
care plan thus has bearing on whether Petitioner was in compliance as
of that time. CMS also argued
that the care plan, which was produced after the survey and apparently
not considered by CMS in making its determination to cite Petitioner for
this deficiency, was insufficient to demonstrate compliance with the care
plan requirement of section 483.20(k)(2). I disagree. The evidence provided
at the hearing establishes that the measures described in the care plan
-- elevation of the resident's heels and regular application of a substance
identified as "skin prep"-- were appropriate. My finding here is supported
by the testimony of the resident's attending physician and Petitioner's
medical director, Dr. Lee, that the black blister on the resident's heel
was not a pressure sore, but instead, a vascular or stasis ulcer that
might have been unavoidable due to her underlying medical conditions.
A vascular ulcer is caused by insufficient blood flow and can arise in
the absence of pressure or trauma. Tr. at 415. This assessment was confirmed
by Ms. Laird, Petitioner's clinical services coordinator, who was qualified
as an expert in nursing. Tr. at 850-54. Dr. Lee testified to his belief
that the breakdown of the resident's skin as manifested by the ulcer on
her heel was probably unavoidable in light of her overall medical condition,
including arterial and venous disease, diabetes, COPD, and in light of
her age. Tr. at 418-19. He also indicated that the blister had healed
and noted that there had been no further blisters on her feet as of the
time of the hearing in November 2000. Tr. at 419-420. While the resident's
condition subsequent to the survey is not dispositive for showing compliance
as of the time of the survey, it supports a finding that the blister on
her heel was an isolated occurrence likely not brought about by the deficiency
alleged in the survey report. At most, CMS
witnesses suggested that the care plan should have provided for two other
treatment measures that the care plan did not discuss prior to the development
of the black blister: "booties" for the resident's feet, and the use of
a special pressure-reducing mattress. These suggestions, however, become
less relevant given the testimony indicating that the blister was a vascular
ulcer not caused by pressure and was potentially unavoidable in light
of the resident's underlying medical conditions. While CMS' expert suggested
that a pressure-relieving mattress could have been provided, CMS did not
establish that the use of such a mattress would have prevented the blister
on the resident's heel or that the appropriate standard of care for the
resident's reddened, mushy heels necessitated the use of such a mattress.
Tr. at 170. CMS' opinion that the facility could conceivably have created
"a better care plan" does not establish any deficiency here (Tr. at 150),
where CMS has not shown that the additional measures that Petitioner might
have considered would have prevented the black blister from developing. The Form 2567
also cited Petitioner's alleged failure to conduct an "ongoing and continuing
assessment" of the resident's care needs. However, the statement did not
cite the specific regulatory subsection that requires the conduct of comprehensive
assessments, 42 C.F.R. § 483.20(b)(2), and CMS did not cite this regulation
in presenting this case. Instead, this alleged deficiency was based on
42 C.F.R. § 483.20(k)(2), which requires the development of a comprehensive
care plan. This regulation does not contain a requirement for continuous
or ongoing assessment, and instead requires only that the care plan be
based on "the comprehensive assessment." The Form 2567, which recites
information regarding the resident's physical condition that was gleaned
from the resident's medical record, such as her various ailments, including
her risk for skin breakdown and the condition of her heels, establishes
that Petitioner conducted a comprehensive assessment of the resident as
required by 42 C.F.R. § 483.20(k)(2). Indeed, in attempting to show that
Petitioner failed to develop a care plan for the resident's heels, CMS
cited Petitioner's assessment of the resident as of the time that her
reddened and mushy heels were first noted. To the extent that this alleged
deficiency was based on the failure to conduct the comprehensive assessment
referred to at 42 CFR § 483.20(k), which is then used to develop a care
plan, CMS thus failed to establish a prima facie case of noncompliance. In this regard,
CMS did not establish that the difference between Petitioner's initial
assessment of the resident as being at moderate risk for skin breakdown
in January 2000, and its subsequent correction of that assessment during
a survey interview to show that the resident had in fact been at "high
risk for pressure sores" amounted to a violation of the applicable requirement
of participation, adversely affected the resident in any way, or would
have made a difference in her treatment. HCFA Ex. 1, at
4, 6. Petitioner's records demonstrate that it was plainly aware that
the resident's various ailments predisposed her to skin breakdown. To the extent
CMS' deficiency finding alleged a failure to conduct ongoing assessments
of the resident's heels, I find that Petitioner demonstrated that it was
in compliance with that requirement of participation. CMS' findings regarding
assessments were based partly on the apparent absence in the nursing notes
of specific references to the resident's heels for two periods of six
and eleven weeks, respectively, between January and May 2000. However,
CMS did not deny Petitioner's assertion that its staff was treating the
resident's heels as per the order of her physician that the heels be treated
with "skin prep." I concur with Petitioner's administrator and its clinical
services coordinator that its staff would necessarily have observed the
resident's heels in the process of administering the prescribed treatment.
Tr. at 730-31, 1040-43. I infer from the absence of specific notes regarding
the resident's heels that the condition of R34's heels remained relatively
unchanged from the written assessment noted in January and February, prior
to the development of the black blister in May. That no written notes
reflect the condition of the heels beyond those made in January, February
and May thus does not establish a violation of the regulation on which
this deficiency finding was based. The regulation does not set out or
prescribe the format or manner in which assessments must be recorded.
While the surveyor did testify as to her opinion that the black blister
would not have developed "from one shift to the next" (Tr. at 135), CMS
did not show that the applicable Medicare requirement of participation
required Petitioner to record observations of the resident's heels on
each shift. Petitioner's failure to record the observations probably does
not represent the best practices that could be employed by a skilled nursing
facility, but does not establish a deficiency under the f-tag that CMS
cited. CMS made much
of the facility's use of "skin prep" to treat the resident's reddened,
mushy heels. The State surveyor testified that "skin prep" is an alcohol-based
cleanser used to cleanse skin prior to the application of a bandage or
tape, and that she didn't understand how it would benefit the resident.
Tr. at 69-70. CMS suggested that it was an inappropriate treatment with
the potential to dry out skin, increasing the likelihood of skin breakdown.
Dr. Lee, the treating physician who prescribed "skin prep," seemed unsure
of its contents. Tr. at 443. However, the certified nursing assistant
(CNA) who participated in treating the resident's heels testified that
the "skin prep" that was applied to her heels is a liquid that forms a
transparent layer over the skin and which was commonly used in the facility
to treat intact skin at risk for breakdown. Tr. at 802-03. Ms. Laird also
described this product as a typical treatment for intact, reddened skin.
Tr. at 855-56. Once the product was identified at the hearing, CMS suggested
that it may have still been inappropriate because it contained alcohol.
Tr. at 809-10. However, Dr. Lee testified with certainty that the use
of an alcohol-based product would not have increased the potential for
a pressure ulcer. Tr. at 466-67. Moreover, the efficacy of using the "skin
prep" substance described by the CNA to treat the resident's heels was
affirmed by CMS' expert witness, Professor Deitrich, who, while not knowing
what specific substance was applied to the resident's heels, testified
that the use of a "skin barrier" product would have been an appropriate
intervention. Tr. at 169-70. I thus find that in using "skin prep," Petitioner
appropriately treated the resident's heels.
The record
thus shows that Petitioner properly assessed the resident as being at
risk for skin breakdown, took measures to prevent the progression of skin
breakdown on her heels, and followed treatment for her heels as prescribed
by the resident's physician. Petitioner cited several different types
of records containing assessments or observations of the resident's skin,
including the disputed care plan, quarterly skin breakdown assessments,
quarterly nursing reviews, nursing notes, and notes provided by Petitioner's
dietary staff (the dietary notes were relevant in that a resident's skin
condition can affect the resident's dietary needs). P. Exs. 14, 15, 17,
19, 25. I disagree
with CMS' argument that it makes no difference to this alleged deficiency
that the blister noted on the resident's heel was not a pressure sore.
The surveyor referred to the blister as a pressure ulcer (Tr. at 85),
and the survey report alleged a deficiency partly on the ground that the
gaps in time between the notation of reddened heels and the black blister
demonstrated that Petitioner did not conduct "ongoing and continuing assessment
to prevent further development of pressure sores." HCFA Ex. 1, at 5. This
finding is unsupported as the resident did not develop a pressure sore
due to the alleged failure to assess her heels. Similarly, because the
blister was not a pressure sore, the testimony of CMS' expert on measures
available to monitor pressure sores, including pressure sore documents
that have pictures and permit grading of sores, does not establish any
deficiency in Petitioner's treatment of the resident's heels. Tr. at 154.
This testimony was also not germane because it addressed the monitoring
of sores, and there was no evidence that the resident had a sore on her
heel prior to the black blister, and CMS' expert confirmed that Petitioner
appropriately monitored the blister. (6)
Id. Based on my
finding that Petitioner observed, monitored and treated the resident's
heels appropriately, I find Petitioner demonstrated that it was in substantial
compliance with the requirements of participation on which this deficiency
was cited, as set forth in 42 C.F.R. §
483.20(k)(2). In its brief,
CMS referred to other clinical entries in the resident's medical records,
including a pressure sore on her buttocks on January 7 that was described
in the Form 2567 and a pressure sore under her breast that was not. However,
my review of the Form 2567 establishes that these observations were not
the basis of this f-tag, which was instead based on the blister noted
on the resident's heel in May 2000. The two pressure sores both healed
uneventfully, and CMS did not cite Petitioner for violating that requirement
of participation regarding the prevention of pressure sores. Similarly,
other findings in the Form 2567 under this f-tag provide no basis for
sustaining a deficiency finding against Petitioner. One of these findings
alleged that the minimum data set (MDS) failed to document peripheral
vascular disease or describe preventative or protective foot care. The
MDS is the federally mandated standardized instrument on which each participating
facility is to record an overview of the resident's status and function
level in the various designated categories. Lakeland
Continuing Care Center, DAB CR683, at 24, n.11 (2000). CMS did
not cite the regulation setting forth the requirements for the MDS, 42
C.F.R. § 483.20(b)(4)(iv)-(v), and it is not the basis for the deficiency
finding under this f-tag. Finally, in light of my determination that Petitioner
properly assessed, planned for and treated the resident's heels, the fact
that a single progress note reflecting a physician's visit on May 5, 2000,
did not document an assessment of any venous stasis changes in the resident's
lower legs does not establish a deficiency. HCFA Ex. 1, at 5-6.
At f-tag F324-G,
the Form 2567 from the May survey alleges that Petitioner's care of Resident
33 (R33) did not comply substantially with the quality of care regulation
at 42 C.F.R. § 483.25(h)(2), which requires that "[e]ach resident receives
adequate supervision and assistance devices to prevent accidents." R33 was 97 years old at the time of the May 2000 survey, and had been admitted to the facility during May 1997 with diagnoses including post-cerebral vascular accident with organic brain damage. She was severely impaired as to decision making, had long and short term memory deficits, and as often as four to six days a week, exhibited symptoms of 'noneasily altered behavior' such as verbal and physical abusiveness, resisting care, and wandering. She was a native German speaker who rarely or never understood what others were saying to her. HCFA Ex. 1, at 7-12; P. Exs. 32, 34; Tr. at 180, 423-24. I have not
repeated verbatim the survey findings from the Form 2567, as I did in
my discussion of the previous deficiency, because of their length and
because they may be easily summarized: it is undisputed that R33 suffered
numerous minor injuries, such as skin tears and bruises to her forearms
and face, and that these injuries were primarily a result of the resident's
well-known combativeness and resistance to care, which were secondary
to her severe vascular dementia. The Form 2567
records five separate instances of injury from March 23 through May 1,
2000. HCFA Ex. 1, at 7-12. These consisted of two scratches on her right
cheek noted on March 23, 2000; a 2.5 x 3.2 cm bruise on her right forearm
noted on April 10, 2000; a 1.0 x 3.0 cm bruise on her nose on April 16;
a 10 x 2.0 cm skin tear noted on her left forearm on April 18; and a 1.5
x 1.0 cm skin tear to her left lower leg on May 1, 2000. The facility
determined that the injuries to her cheek and nose were self-inflicted
and sustained while staff was attempting to remove her glasses for cleaning,
and the scratch to her leg was attributed to her resistance to care. HCFA
Ex. 3. The Form 2567 did not note specific causes of the other two injuries,
but neither party disputed that this resident's injuries were likely the
result of her combativeness and might possibly have resulted from her
lashing out, sometimes while receiving care, and sometimes when no one
else was present. Tr. at 666-67. In addition
to the five specific injuries described in the Form 2567, the record reveals
that this resident suffered many other, similar injuries. Petitioner provided
a summary of the resident's records indicating that R34 sustained a total
of 17 separate injuries from March 1999 through May 18, 2000 (including
those noted on the Form 2567). P. Ex. 30. Most of these were skin tears
or scratches to the resident's forearms, as well as two leg injuries and
two that were said to have resulted from dry skin. Id. CMS argued
that Petitioner failed to respond properly to the incidents of injury
by developing and implementing adequate approaches to address the resident's
risk of injury from her combative and resistive behaviors. In response
to Petitioner's claim that it made a total of 21 care plan revisions and
carried out 45 interventions to address the resident's agitation and combativeness,
CMS argued that many of the claimed interventions were simply the same
unsuccessful interventions attempted over and over and that many of the
care plan revisions were actually progress notes, summaries, or lesson
plans. The relevant
regulation does not require that a facility be an absolute guarantor that
a resident will not suffer injuries as a result of the resident's own
behaviors. The DAB has held that the regulation "does not amount to strict
liability or require absolute success in an obviously difficult task."
Woodstock Care Center,
DAB No. 1726, at 27 (2000). 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. Koester
Pavilion, DAB No. 1750 (2000). In the absence
of any requirement that a facility be a guarantor against accidental injuries,
the mere occurrence of injuries by itself is not sufficient to establish
a prima facie case of a violation. Here, aside from recounting the number
and frequency of the resident's injuries, CMS argued that the measures
Petitioner took to address her combativeness were incomplete, and speculated
about what the facility might have done differently, or earlier. However,
I find that all of the evidence establishes that Petitioner did, in fact,
take appropriate measures to address the resident's history of injuring
herself due to her combativeness and was in compliance with that regulation.
Because I find that the evidence as a whole demonstrates compliance, I
do not address separately the question of whether the evidence submitted
by CMS alone would have established a prima facie case of noncompliance. I first note
that the evidence uniformly established that R33 was, as a result of severe
vascular dementia, a highly combative individual who was often extremely
difficult and agitated. The evidence was consistent in recounting non-easily
altered behaviors that included physical abusiveness, resistance to care,
and wandering, which were displayed four to six days a week. HCFA Ex.
3; Tr. at 245-46; P. Ex. 32. When staff attempted to administer care,
she frequently pulled, flailed her arms, and shouted in German, sometimes
injuring herself secondary to her resistance to care. Tr. at 421-22, 666-67,
1070. The records document that, for example, she would resist having
her glasses removed for cleaning, and that she furthermore did this even
at times when staff was not attempting to remove her glasses. HCFA Ex.
3. These behaviors also occurred when staff was not attempting to provide
care; she was observed screaming and striking the bed rails of her bed
when there was no one in the room. Tr. at 666-67. Her behaviors were noted
in the records provided as early as March 1999, and a review of the records
by CMS' expert witness disclosed some 33 episodes of combativeness, assaultiveness,
and yelling at staff. P. Ex. 34; Tr. at 171. The nature
and severity of R33's behaviors were confirmed by her granddaughter, who
supplied the facility with a statement that the resident's dementia caused
her to be combative and that it made no difference whether she was spoken
to in German or English, and that she had behaved combatively towards
the granddaughter and another relative. P. Ex. 44. The statement recalled
how, when presented with a tray containing food described as special treats,
the resident would sometimes throw the tray down. Id. While she displayed
these behaviors on an ongoing basis, there was also an element of unpredictability
to her conduct, as there were times when she could be approached by staff,
and other times when their attempts to approach her evoked agitation and
combative reactions. Tr. at 825, 1070; P. Ex. 44. While the Form 2567
mentions one occasion on which the surveyor observed the resident in a
non-agitated state, CMS did not dispute or attempt to contradict the considerable
evidence confirming her behavior problems, or their severity, frequency,
and unpredictable nature. There is no
question, then, that this resident would present great challenges to any
facility responsible for her care. Moreover, given her age and that her
severe dementia and behavior were worsening, it does not seem likely that
any substantial improvement in her behavior could be expected or achieved.
HCFA Ex. 3, at 17, 19, 33; Tr. at 420-21; P. Exs. 37, 39. Based on my
review of the evidence, I conclude that Petitioner made reasonable, ongoing
efforts to care for this resident sufficient to comply with the regulation.
As Petitioner argued, the record documents the facility's ongoing attempts
to devise and implement different strategies to deal with her combative
behaviors. These different techniques included such diverse things as
trimming her nails to reduce the possibility of the resident's scratching
herself; providing her with long sleeves and padded gloves or sleeves
to prevent bruising; equipping her bed with padded side rails; giving
the staff periodic training as well as ongoing reminders of the need to
provide gentle handling during the administration of care and to vary
the time of treatment by not approaching the resident during periods of
increased agitation; using skin lotion to treat dry and thus potentially
brittle skin. P. Exs. 30-43; Tr. at 1073-76. Petitioner's
medical director, Dr. Lee, testified that he and facility staff talked
about the resident approximately every two weeks in an effort to try to
figure out ways to deal with her combativeness. Tr. at 427. Similarly,
Petitioner's social services director described morning meetings of department
heads, at which R33's condition was discussed. Tr. at 1071-73. Sometimes
it appeared that simpler, less conventional "interventions" met with the
most success, such as providing her with bananas and the sweetened coffee
she was known to like, and calling her name in a quiet voice while approaching
her; one particular nurses's assistant apparently had some success approaching
her in this fashion. Tr. at 818-820; 1075. She was also provided with
music and given a small keyboard to play with. Id.
The facility also used medication in its attempts to control her agitation,
and Dr. Lee also testified about continuing efforts to adjust the medication
to appropriate levels. Tr. at 420; P. Ex. 44. The facility also produced
records indicating that it made a number of updates or revisions to the
resident's care plan as part of its attempts to deal with her agitation
and combative behaviors. P. Exs. 30, 36. While asserting
that Petitioner failed to take reasonable actions to prevent this resident
from injuring herself further, CMS produced only a few concrete suggestions
as to what Petitioner could have done differently, or additionally. Specifically,
CMS argued that Petitioner should have refrained from removing the resident's
glasses; ordered a psychiatric consultation; provided training to its
staff or adjusted staff interventions; provided for more supervision of
her care; and tried assistive devices. HCFA Reply Brief, at 14-15, citing
Tr. at 191, 196. This brief
list of other techniques that the facility could have attempted does not
establish a violation of the regulation. The list is speculative in that
CMS did not demonstrate that those suggestions would have made an appreciable
difference in R33's dementia-related behaviors or kept her from sustaining
minor injuries as a result of those behaviors. Moreover, some of these
suggestions were indeed implemented by the facility. A psychiatrist was
involved in the care given to R33, and staff testified that her care included
ordering a psychiatric consult, training staff or adjusting staff interventions,
providing for more supervision of her care, or trying assistive devices.
Tr. at 422, 458. The staff received training in ways to deal with the
residents to avoid injuries. P. Ex. 47; Tr. at 682-83. Dr. Lee testified
that the facility did begin to refrain from removing the resident's glasses
as this tended to agitate her. Tr. at 422-23. The fact that the facility
did not attempt this strategy until after the May survey is not, in my
view, a sufficiently serious shortcoming or failure on the facility's
part to sustain a deficiency finding. Moreover, the suggestion that the
facility not remove her glasses presents the question of how they would
be able to clean the resident, and her glasses, which is why the glasses
were being removed at all. That one particular
employee, the nurse's assistant referenced above, seemed to have more
success than others at dealing with this resident, apparently by leaning
close to her and calling her name softly, confirms the difficult and subjective
nature of caring for this resident. Petitioner's medical director, Dr.
Lee, testified that care planning for end-stage dementia patients can
be more of an art than a science. Tr. at 425-26. His testimony was consistent
with literature from the Alzheimer's Association discussing the treatment
of various dementias (including vascular dementia), which notes that while
there are basic principles for intervening with patients afflicted with
dementia, there are no techniques that work with every patient or work
each time employed, and that the treatment needs of patients will vary
from day to day. P. Ex. 45, at 2, 8; Tr. at 676. Dr. Lee testified that
some patients might be mollified or calmed by being given a doll to play
with, and gave the example of a patient who had been in the laundry business
and was calmed by being given laundry to fold. Tr. at 426. Similarly,
the literature on the treatment of Alzheimer's disease and other dementias
mentions the use of activities such as looking at photo albums and cracking
nuts as a means of relaxing patients. P. Ex. 45, at 6. Thus, I find that
the various strategies that the facility considered and attempted in order
to approach and interact with this resident with a minimum of combativeness,
such as supplying her with music and sweet coffee, could indeed qualify
as injury prevention strategies, despite CMS' suggestion to the contrary.
Tr. at 1008-09. CMS' other
criticisms of Petitioner's care of this resident do not rise to the level
of a deficiency. For example, CMS' argument that the facility failed to
conduct a thorough investigation into such things as the precipitating
factors for the resident's behavior is not well-founded where, as here,
the cause of her behaviors was well-known to the facility and to the resident's
family, and had been for some time. Suggestions that the resident may
have been in pain or needing to use the bathroom during her combative
interludes were speculative and not supported by the evidence. Finally,
CMS' criticism that Petitioner failed to evaluate why the preventive measures
used were inadequate or whether the care plan was being followed does
not demonstrate a deficiency where the deficiency finding was not based
on a failure to follow a care plan. While the DAB has held that a facility is required to do everything in its power to prevent accidents (Koester Pavilion, supra), I do not interpret this standard to compel a deficiency finding simply because CMS can point to a small number of possible interventions that the facility might have attempted or attempted earlier, where the record demonstrates that the facility was taking appropriate, reasonable measures to deal with a difficult resident who exhibits worsening and non-easily altered behaviors. I find that the facility responded reasonably to the challenges this resident posed and made great efforts to accommodate her specific and changing needs. The fact that the same interventions were tried with varying success on different occasions does not make for a failure to comply substantially with the regulation, given the nature of the resident's condition which made it difficult to predict what would work at a given time, or at all. While it may be possible to second-guess the facility and argue that there were things that Petitioner could have done differently, there is no evidence that Petitioner's failure to pursue possible or theoretical courses of action had the potential for causing more than minimal harm to this or other residents.
For the same
reasons I reversed the deficiency finding relating to R33, I also conclude
that Petitioner was not deficient in its treatment of Resident 35 (R35),
another resident who was the subject of a deficiency finding under the
requirement of 42 C.F.R. § 483.25(h)(2), that residents receive adequate
supervision and assistance devices to prevent accidents. Here again, I
find that the facility took reasonable measures to care for this resident
sufficient to constitute compliance with that regulation. As with the
prior deficiency finding, because I find that the evidence provided by
Petitioner, some of which was also introduced by CMS, demonstrates compliance
with the relevant standard, I do not address separately the question of
whether the evidence submitted by CMS alone established a prima facie
case of noncompliance. At the time
of the May survey, R35 was a 75-year-old man who needed limited assistance
with bed mobility and transfer, as well as extensive assistance going
to the bathroom. He had cognitive impairment, memory problems, and poor
decision making. HCFA Ex. 4, at 1; Tr. at 204-05. He was deemed to be
at risk for falls and injuries secondary to decreased mobility, confusion
and highly impaired vision. HCFA Ex. 4, at 21; Tr. at 207-08. Testimony
indicates that his tendency to fall stemmed from his independence and
unwillingness to seek assistance. Tr. at 690, 1078-1080. Although cognitively
impaired and confused, the resident was alert, had a strong desire to
remain independent, and was unrealistic about his own capabilities. Id.
Around the time of the survey and on other occasions, he had pneumonia,
which further weakened him and made him more likely to fall when he attempted
to assert his independence. Tr. at 200-01, 205, 1078; P. Ex. 63, at 1-2;
P Ex. 64, at 5-6. Like R33, R35
became the subject of a deficiency finding as the result of a number of
accidents, in his case falls. The Form 2567 on which this alleged deficiency
is based recounts three falls, which occurred on December 18, 1999, April
19, and May 1, 2000. The December 18, 1999 fall occurred after the resident
disconnected a clip alarm that connected the resident's clothing to his
bed or wheelchair and which would be activated if he attempted to leave
the bed or wheelchair. HCFA Ex. 1, at 12-13. In the April 19, 2000 fall,
the resident was found on the floor and explained that he had attempted
to go to the bathroom; the facility determined that the fall resulted
from his unstable condition secondary to pneumonia. Finally, on May 1,
2000, the resident fell out of bed while reaching for his shoes; it was
determined that he had disconnected the clip alarm. HCFA Ex. 1, at 12-13.
(7) Based on my
review of the record, I conclude that the facility was indeed providing
assistance devices and supervision sufficient to demonstrate compliance
with the regulation. That Petitioner's efforts were not always successful
does not establish a violation of the standard of care, as I find that
the evidence and the testimony of Petitioner's witnesses established that
R35 was provided adequate care and supervision. I conclude that Petitioner
responded appropriately to the challenges presented by this difficult
and independently-minded resident. The record disclosed that the facility
employed the following assistance devices in its attempts to address the
resident's falls:
In addition
to these assistance devices, the facility's records disclose numerous
instances where the facility attempted to address the resident's problems
with falling. While many of these interventions occurred in 1999, when
the facility was developing and implementing a series of care plans for
risk of falls, they demonstrate nonetheless that the facility was making
assiduous efforts to address the resident's history of falls. These interventions
attempted included: assisting the resident to the bathroom after meals,
placing the call light in reach, monitoring for signs and symptoms of
unknown injury, continuing to remind the resident of the risk of not calling
for assistance when needed, and, in June 2000, moving the resident to
a room directly across from the nurses' station. P. Ex. 54, at 6; P Ex.
59, at 1-2; Tr. at 199-200, 925-38. The facility prepared assessment protocol
reports for visual function, functional rehabilitation potential to determine
if the resident might have the potential to improve in his ability to
perform activities of daily living, and for falls specifically which addressed
the history of factors contributing to his falls. Tr. at 922-25; P. Ex.
51. R35 also underwent physical therapy, occupational therapy, transfer
training, and had restorative nurse aides working with him. HCFA Ex. 1,
at 12-14; P. Exs. 53, 57; Tr. at 1079. The facility also conducted fall
risk assessments on a quarterly basis. P. Ex. 52; Tr. at 924-25. Although
the alleged deficiency at issue here was not based on a failure to properly
assess or care plan for the resident, I have mentioned these measures
because they are consistent with and lend credibility to Petitioner's
arguments that it was complying with the regulatory requirement that it
provide assistance devices. According to
the Form 2567, Petitioner's care of this resident was deemed deficient
because: Petitioner's interdisciplinary team, in reviewing the May 1,
2000 fall, failed to discuss the fact that the resident had disconnected
the clip alarm prior to his fall; Petitioner failed to extend the use
of the pad alarm to the resident's bed at the time that it used a pad
alarm to replace the clip alarm in the wheelchair following the resident's
fall from his bed on December 18, 1999; and, during the May survey, the
"grabber" was provided to the resident on only one occasion. In light of
evidence showing that Petitioner was in compliance with the regulation,
these criticisms do not rise to the level of a deficiency. I note that
the surveyor did not dispute that the facility actually care planned for
R35's falls and tried various interventions. Tr. at 367. Instead, from
the Form 2567 and from CMS' briefs, it appears that the alleged deficiency
was based primarily on the fact that the resident continued to experience
falls. As I have noted above, the mere occurrence of falls does not by
itself demonstrate a deficiency, as the regulation does not require the
facility to be an absolute guarantor against accidents. What is determinative
is the fashion in which the facility provided care for the resident and
the measures it took to address his propensity to fall while still respecting
his desire for independence. Because the regulation is general and does
not provide specific standards or lists or interventions that must be
attempted, a determination of whether a facility is in compliance entails
a degree of subjectivity. I conclude that the facility's efforts to deal
with this resident, which I summarized above, demonstrate that it took
reasonable measures to address the resident's tendency to fall sufficient
to comply with the regulation. I find that
CMS' suggestions as to what the facility could have done differently do
not demonstrate a deficiency. CMS argued that Petitioner could have tried
interventions such as lowering R35's bed, increasing the supervision and
assuring he was engaged in daily activities. In particular, CMS argued
that Petitioner should have moved R35 to a room across from the nurses'
station sooner than early June 2000. This criticism is speculative and
does not support a deficiency finding. While Petitioner deemed this intervention
successful as of June 21, because R35 was no longer making attempts to
transfer himself, CMS' argument raises the question of how CMS would have
regarded this intervention had it been tried earlier and the resident
had continued to experience falls. I note, for example, that R35 went
three months without a fall from January to April 2000, yet CMS still
cited the subsequent fall as evidence of the deficient care of this resident.
As I noted in the case of R33, that Petitioner might have attempted a
particular intervention earlier is not a sufficient basis to find a deficiency,
where the record demonstrates that the facility was taking appropriate,
reasonable measures to deal with the risk of falls for this resident.
CMS did not suggest that the facility could have or should have placed
the resident within the view of its staff around the clock, and at the
hearing seemed to recognize the inherent difficulty in administering uninterrupted
supervision. Tr. at 765-66. The facility faced a great challenge in dealing
with a resident who was determined to refuse assistance and performed
acceptably under the circumstances. It is hard
to envision a situation where, with the benefit of hindsight, one would
not be able to suggest some alternative interventions that a facility
could conceivably have attempted; the ability to do so does not demonstrate
noncompliance where the evidence demonstrates, as it does here, that a
facility was ensuring that the resident was receiving adequate supervision
and assistance devices to prevent accidents. While it may be possible
to second-guess the facility and argue that there were things that Petitioner
could have done differently, there is no evidence that Petitioner's failure
to pursue other possible courses of action had the potential for causing
more than minimal harm to R35 or other residents. Characteristic
of a speculative finding was CMS' argument that interventions such as
the grabber, the transfer pole and physical therapy were ineffective because
they failed to address R35's failure to request assistance. CMS Brief
at 32. I find instead that testimony indicated that interventions such
as these were provided specifically because of R35's unwillingness
to request assistance. Tr. at 690-95, 1077-1080. The facility recognized
that this was an independent-minded individual who believed he could do
more than he was capable of, and who was unwilling to seek assistance
in ambulating or transferring himself from his bed to a wheel chair, or
in attempting to pick up objects. Devices such as the grabber and the
transfer pole placed near his bed, as well as the physical therapy, were
provided in recognition of the resident's unwillingness to seek assistance,
and in hopes of providing him some means to increase the likelihood that
he could accomplish these tasks on his own, given that he was likely to
repeat his pattern of refusing to request, and declining to accept, assistance.
(8) I find also
that CMS focused undue attention on the issue of the grabber and the extent
to which it was available to the resident. Petitioner's administrator
and its lead certified nursing assistant (CNA) both testified credibly
regarding their efforts to get this resident to use the grabber to pick
up objects, despite his belief that it was "dumb" or inconvenient. Tr.
at 690-91, 800-01. I found credible the statements of Petitioner staff
who had contact with the resident on an ongoing basis that the grabber
was made available for the resident's use and that he was counseled on
its use; I find their testimony on this subject more convincing than that
of the surveyor who testified that when she observed the resident with
the grabber he did not seem to know what it was. Tr. at 205. In light
of the testimony of Petitioner's staff I find the fact that the surveyor
observed the grabber with the resident on only one of the five times that
she saw the resident during the day of the survey visit does not establish
that he was not provided with the grabber as part of a good-faith overall
effort to reduce his risk of falls. CMS also argued that only one of 17 interventions listed in the care plans developed for R35 was "individualized," and cited the surveyor's "expert testimony that the facility failed to assess the effectiveness of its use of the tab alarm and revise the care plans accordingly." CMS' Brief, at 30; Tr. at 267, 369. These arguments do not alter my conclusion. CMS' argument and the surveyor's opinion might have been germane had a deficiency been alleged under the care plan requirement at 42 C.F.R. § 483.20(k)(2), but is not dispositive on the question of whether the facility provide supervision and assistance devices to prevent accidents. At the hearing I sustained Petitioner's objection to the surveyor's testimony to the effect that the facility should have conducted a more thorough assessment of the situation, on the grounds that this was not a basis for the alleged deficiency listed in the Form 2567. Tr. at 311-13. Regarding the issue at hand, I found credible the opinion of Petitioner's clinical services coordinator, who was qualified as an expert at supervising, implementing, and evaluating the care provided by Petitioner, that the facility's interventions were very appropriate and above the standard of practice for nursing in Petitioner's community. Tr. at 842-44, 937-38. That this witness was in the employ of Petitioner does not diminish her credibility because I find that her opinion was consistent with the evidence presented, which demonstrated to my satisfaction that Petitioner reasonably provided this resident with assistance devices and supervision as required by the regulation.
This regulation
requires that, for each resident, the services provided or arranged by
the facility must be provided by qualified persons in accordance with
each resident's written plan of care. (9)
It comprises two parts: a requirement that only qualified persons be involved
in providing services and, second, that the services be provided in accordance
with the resident's written plan of care. Rose
Care Center-Trumann, DAB CR664, at 5 (2000). Here, CMS alleged
that services were provided by unqualified persons. The alleged
deficiency primarily concerns the delivery and presentation of meals (tray
set-up) to resident 100 (R100). As described in the Form 2567, the survey
findings include:
HCFA Ex. 7,
at 3-4. None of these
observations support the alleged deficiency. A facility fails to comply
substantially with a participation requirement at the D level or higher
where it is deficient in meeting that requirement and the deficiency poses
a potential for causing more than minimal harm to the health and safety
of the facility's residents. See,
42 C.F.R. § 488.301; Community
Nursing & Rehabilitation Center, DAB CR770, at 12 (2001). In
this case, I find that CMS failed to make a prima facie showing of noncompliance
because CMS did not establish that the observations noted in the Form
2567 had the potential to cause more than minimal harm to the resident's
health and safety. In making this
determination I was particularly influenced by the testimony of CMS' expert
witness, who was qualified as an expert gerontological nurse/practitioner.
This witness did not support CMS' allegation that the deficiencies described
in the Form 2567 posed the threat of more than minimal harm. Instead,
she was only willing to state that Petitioner's failure to follow the
care plan for this resident (which in the context of the Form 2567 I interpret
as referring to the tray set-up defects noted by the surveyor) resulted
in "potential harm." Tr. at 515. She did not state that there was any
potential for more than minimal harm to the resident as required to establish
a deficiency. Moreover, the
expert witness declined to support CMS' suggestion that the tray-set up
defects were responsible for or contributed to an acute illness that the
resident experienced around the time of the survey. CMS' Brief, at 44.
(The resident was being treated for symptoms of a urinary tract infection,
although the diagnosis could not be confirmed because of the resident's
resistance to providing diagnostic specimens, and was experiencing nausea
and vomiting. Tr. at 328-31, 429-32, 504-05; HCFA Ex. 10, at 49-63. On
or around June 15, she was briefly transferred to a hospital for treatment
of dehydration. Id.) On
the contrary, CMS' expert stated that to her knowledge there was no causal
connection between anything the facility did or did not do and the fact
that the resident became ill. Tr. at 514. Similarly, when she was asked
if other methods available to increase the resident's calorie and fluid
intake would have prevented her illness, CMS' expert agreed only that
the worsening of the conditions was potentially avoidable but did not
link the illness and the resident's tray set-up. Tr. at 502-03. CMS' expert
also declined to state whether or not the failure of Petitioner's staff
to provide assistance as designed in the care plan was acceptable nursing
practice for a facility in her community for R100. It is only required,
she replied, that the facility "provide assistance as needed by the resident."
Tr. at 508-09. There is no evidence that Petitioner failed to provide
needed assistance to this resident. Under this
f-tag the Form 2567 also lists information regarding the percentage of
her meals that the resident ate from June 9 through June 14, 2000, and
the amount of fluid she consumed in a 24-hour period from June 14 to 15.
(10) HCFA Ex. 7, at 4-5. This information does not provide a
basis for a deficiency finding. CMS' witnesses did not refer to this information
or explain how it would support a deficiency finding, and CMS did not
cite this information in its briefs before me. When asked if she knew
what the resident ate each day as a percentage of her meals, the surveyor
responded only that the resident had no documented weight loss. Tr. at
272-73. Finally, CMS
did not establish why the fact that one CNA on one occasion did not, when
asked to describe her instructions regarding the resident's care, provide
information about the resident's nutritional or hydrational needs, would
establish a violation of the regulation cited as the basis for this alleged
deficiency. CMS did not provide evidence to establish generally that this
response demonstrated that care was not provided by "qualified persons"
as required by the regulation, and did not demonstrate why the response
supplied by this CNA (who, in any event, was not the CNA responsible for
the delivery of R100's meals (Tr. at 1052)) could have had the potential
to cause more than minimal harm to the resident. While I conclude
that CMS did not establish a prima facie case, I also note that this was
not a technical failing on CMS' part, as Petitioner's evidence established
legitimate reasons for the tray set-up circumstances that the surveyor
described. The evidence established that, like R33, this resident was
very difficult and prone to outbursts. She had specific, unusual food
preferences, and would get very upset if those preferences were not fulfilled.
For instance, she insisted on lunches and dinners consisting primarily
of four cheese sandwiches, two slices of cheese on a side plate and red
jell-O, but only in a specific shade of red. Tr. at 697-98, 1064. The
resident did not want her tray set up or touched beyond receiving assistance
with opening up the milk container. Tr. at 710. When her demands were
not met, she would engage in "wild" behavior such as yelling, and not
allowing anybody, even her husband when he visited, to care for or console
her. Tr. at 427-28. She threw jell-O at Petitioner's dietary manager,
and a wastebasket at a member of the kitchen staff. Tr. at 1064-65. As noted above,
the evidence also established that the resident was undergoing an acute
illness around the time of the survey, and was being treated with antibiotics
and experiencing nausea, all of which likely exacerbated her unwillingness
to eat. Thus, the fact that the tray was not completely set up when observed
by the surveyor was likely a reasonable response to the resident's overall
condition and demands. Petitioner's Director of Nursing testified credibly
that during the survey visit, the CNA reported to her that she said she
brought the tray into R100's room and attempted to set up the tray, but
that the resident would not allow the CNA to place the tray over the resident's
bed or set it up beyond opening the milk, which the CNA was able to accomplish
after coaxing the resident. Tr. at 1049-51. Some of Petitioner's evidence that I have discussed here (like her specific food preferences and the fact that she would become very angry if these preferences were not met) was included in CMS' case and thus support my determination that CMS failed to establish a prima facie case of a deficiency. Tr. at 270-72; HCFA Ex. 10, at 28, 30.
This alleged
deficiency, involving Resident 103 (R103), a 79-year-old resident with
diagnoses including COPD, bronchitis and glaucoma, and who had short term
memory problems, was based on apparent discrepancies regarding R103's
advanced directive, instructions reflecting the resident's decision on
whether to attempt resuscitation or CPR (cardiopulmonary resuscitation)
in the event of a medical emergency. While the MDS contained a faxed physician's
order dated June 8, 2000, changing her advanced directive from "no code"
(do not resuscitate) to "full code" (resuscitate) status and a June 8
advanced directive form signed by the resident confirming the change,
she was seen on June 14 wearing a green wrist bracelet indicating a "no
code" advanced directive, and the charge nurse, in response to the surveyor's
question, stated at that time that the resident was a "no code." HCFA
Ex. 7, at 5-7; Tr. at 525-32. I find that
CMS established a prima facie violation of 42 C.F.R. § 483.25, which requires
that a resident 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. The wrist bracelet did not reflect the resident's
actual advanced directive, and there is little question that an erroneous
instruction to forgo CPR or other resuscitation in the event of a medical
emergency would have the potential for causing much more than minimal
harm, notwithstanding Petitioner's arguments that these procedures are
of limited value to elderly nursing home residents beset with multiple
and potentially terminal ailments. Although the regulation supporting
this deficiency contains no specific instructions or standards regarding
advanced directives, I find as a matter of law that adherence to a resident's
wishes regarding resuscitation falls within the ambit of the necessary
care and services to maintain well-being described in the regulation. However, I
find that by a preponderance of the evidence Petitioner rebutted CMS'
prima facie case of noncompliance and established that it was complying
with the regulation. Specifically, Petitioner, through the testimony of
its witnesses, established to my satisfaction that, in the event of a
medical emergency, it would determine advanced directive or code status
from a resident's medical record, rather than the resident's wrist bracelet.
Tr. at 664, 715-26, 769-70, 772-81, 1031-35. I found credible the testimony
of Ms. Laird, Petitioner's clinical services coordinator and an expert
in nursing, that the facility's staff would not rely on the wrist bracelet,
or other code indicia outside of the medical record, in determining to
withhold resuscitation. Tr. at 1031-35. Her testimony was consistent with
that of the surveyor, who reported that the charge nurse and the case
manager
both told him that the resuscitation decision would be made based on the
record, and not on the wrist band. Tr. at 528-29, 540. Petitioner's
witnesses were also consistent in their description of how the facility
would respond to a medical emergency that could potentially require resuscitation;
this process would involve about four staff members, at least one of whom
would be looking through the resident's medical record to ascertain the
advanced directive status. Tr. at 721-22, 953-57. CMS and the surveyor
agreed that the resident's correct code status was documented at several
points in the medical record, and the surveyor reported that the facility
staff correctly determined R103's code status by reviewing her record.
CMS' Brief, at 45-46; Tr. at 533, 539. While the surveyor reported that
it took "quite a while" for staff to locate definitive code information
in the resident's record (Tr. at 528), he did not state exactly how long
it took, and moreover I am satisfied that this situation - responding
to a surveyor's inquiry - was not representative of a genuine emergency
or the manner in which Petitioner's staff would perform in such circumstances. The fact that one nurse, who was otherwise deemed by the surveyor to be a very good charge nurse who always seemed to know about the residents (Tr. at 526), on this one occasion answered incorrectly when asked about the resident's code status, does not establish a prima facie case of a violation. No evidence was introduced before me to suggest that nurses are expected to memorize the advanced directive decisions of their residents, or that the decision whether or not to resuscitate a resident would be made based on a nurse's recollection. Tr. at 956-57. As I noted above, the regulation supporting this deficiency contains no specific instructions or standards regarding advanced directives or their implementation. In the absence of such specific standards, I conclude that Petitioner established that it was in substantial compliance with the regulation.
The deficiency
alleged for this resident was similar to the deficiency alleged in the
May survey for R35, in that this resident fell while attempting to go
to the bathroom and transfer herself unassisted. R101, who was
91-years-old at the time of the survey, had been admitted to the facility
in September 1999, with diagnoses including hypothyroidism, pressure sores,
dementia and depression. P. Ex. 99; HCFA Ex. 7, at 9-12; HCFA Ex. 9, at
4. She had long and short-term memory problems, and was impaired with
decision making, for which she needed supervision and cuing. She also
needed limited assistance generally and extensive assistance with transferring
herself. Id.; Tr. at 219-20. The Form 2567
reports the following findings from the June survey:
HCFA Ex. 7,
at 9-12. CMS argued
that Petitioner failed to comply with the regulation because assistance
devices such as the toilet seat alarm are of no value in preventing accidents
if disconnected or if facility staff fails to respond to the alarm in
a timely fashion. The use of
assistance devices in a manner that defeats their utility, when accompanied
by the occurrence of falls, may establish a prima facie case that a facility
has failed to provide adequate supervision and assistance devices to prevent
accidents, as required by the regulation. Moreover, such failures clearly
have the potential for more than minimal harm for a resident who experiences
falls. However, I find that the evidence establishes that Petitioner was
providing assistance devices and supervision sufficient to demonstrate
compliance with the regulation. In making this finding, I was particularly
influenced by testimony describing how the resident was able to realize
her desire for independence and privacy through the overall improvement
in her ability to ambulate that occurred subsequent to her admission to
the facility. Petitioner's
rehabilitation director described how R101, who was unable to ambulate
upon admission, very much wanted to walk again and did accomplish that
goal to some degree. While in the facility, she apparently regained the
ability to walk, was fitted with a foot or leg brace to assist her in
walking, and transfer poles were installed in her room and bathroom to
enable her to leave her bed and use the toilet unassisted. Tr. at 224,
699, 786-89. The improvement in the resident's condition was also noted
by CMS' expert gerontological nurse/practitioner, who stated, based on
her review of Petitioner's records, that R101's abilities increased during
her stay at the facility. She noted that the facility was able to greatly
increase the resident's ability to perform activities of daily living,
and that she had been improving throughout the spring and increasing the
distance she could ambulate, to the point that as of a June 5, 2000 monthly
summary she was ambulating 800 to 900 feet with minimal assistance. Tr.
at 507. Aside from
her desire to ambulate, this resident was also concerned about her privacy.
Tr. at 700. She very much wanted to be able to get in and out of bed by
herself and not have to wait for assistance to be able to use the bathroom.
Tr. 788. She often expressed concern about privacy while using the bathroom,
and found it embarrassing when she was asked to demonstrate transferring
to the toilet for surveyors and staff. Tr. at 803-04, 812-13. Her increased
abilities apparently enabled her to achieve these goals, and in June 2000,
around the time of the survey, she succeeded in transferring herself from
bed to wheelchair and back, and the same with the toilet. Tr. at 790. In dealing
with this resident, then, the facility had to walk a delicate line between
protecting her against falls, while respecting her desire for privacy
and independence, and improving her ability to ambulate, which in turn
increased the risk that she might fall. In light of these concerns, I
conclude that a failure to provide assistance devices and supervision
was not established by the surveyor's observation that the staff did not
rush to the resident's aid when an alarm indicated that she was attempting
to get off the toilet by herself, or by the fact that while transferring
herself in the bathroom she forgot to set both brakes of her wheelchair
before rising. Regarding the wheelchair, I note that the resident indeed
transferred herself successfully to the toilet on that occasion. No failure
of supervision was demonstrated by the apparent failure of Petitioner's
staff to intervene to set the other brake, or to prevent her from attempting
to transfer herself until the other brake was set, because the purpose
of the demonstration was for the surveyors to determine whether she could,
in fact, transfer herself by herself (she could). Her ability to ambulate
and transfer herself to the toilet also informs my determination that
a violation of the regulation was not established by the staff's failure
to rush to her aid when the toilet alarm sounded. That the alarm was seen
turned off on one occasion does not alter my determination that the facility
was substantially in compliance with the regulation. Similarly, given
the resident's changing ambulatory abilities, the observation that a nurse's
aide incorrectly reported the resident's risk for falls and transferred
herself to her toilet "all the time," which the surveyor said contradicted
the facility's assessment of the resident, does not indicate that she
was not appropriately supervised or did not have assistance devices. HCFA
Ex. 7, at 11; Tr. at 224. Finally, I note that there appeared to be no
causal connection between the alleged deficiencies noted in the Form 2567
and the two falls noted therein. As I noted
in my analysis of the alleged deficiencies regarding R33, the absence
of regulatory standards or mandated interventions that must be attempted
means that a determination of whether a facility is in compliance entails
a degree of subjectivity. Here, I find substantial compliance because
the record demonstrates that the facility was taking appropriate, reasonable
measures to deal with a resident's particular needs, desires and abilities.
Based on my review of the record, I conclude that the facility was indeed
providing assistance devices and supervision to R101. V.
Conclusion. I find no basis for the imposition of a CMP from May 19, 2000 through June 24, 2000, and I further find no basis for the termination of the facility on June 24, 2000. |
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| JUDGE | |
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Alfonso J. Montano Administrative Law Judge |
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| FOOTNOTES | |
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1. "F-tag" is the term CMS and the State agencies that perform the surveys use to describe deficiencies in specific requirements set forth in 42 C.F.R. Part 483, Subpart B. 2. The facility was reinstated subsequent to the hearing held November 14-17, 2000. 3. Because the exhibits were admitted as "HCFA exhibits," to stay consistent, I refer to them as "HCFA Exhibits," not "CMS Exhibits." 4. The Form 2567 and the parties' submissions cited identified 42 C.F.R. § 483.20(d)(2) as the source of this requirement. However, section 483.20(d) was redesignated as section 483.20(k) in December 1997. 62 Fed. Reg. 67,174, 67,211 (1997). 5. CMS attempted to discredit this witness by questioning her during voir dire about a 1993 disciplinary action that resulted in her ceasing the practice of nursing for one month and a three-year period of probation. Tr. at 836-43. However, I found that the witness was forthright in discussing that matter and that it had no relevance to her testimony, which I found to be fully credible. 6. Because the facility responded appropriately when the black blister was noted on the resident's heel, the ALJ decision that CMS cited regarding the duty to revise care plans does not apply. Haverhill Care Center, DAB CR522, at 21-22 (1998). In that case, the ALJ cited the facility's failure to revise the care plan after an event, i.e., a fall. Here, however, CMS in alleging the deficiency addresses the facility's actions before the precipitating event of the black blister. CMS did not argue that the facility failed to adjust its care of the resident's heel to account for the black blister. Tr. at 154. 7. It is not disputed that the resident experienced other falls. During the hearing the State surveyor testified that R35 fell six times during an approximately five-month period from November 1999 through May 2000. Tr. at 204, 369. Facility records, including interdisciplinary progress notes introduced by Petitioner, disclose three other falls during the five month period to which the surveyor referred at the hearing (beyond the falls noted in the Form 2567). These occurred on November 22, 1999, when the resident fell from his wheelchair after disconnecting the clip alarm (P. Ex. 59, at 6); on January 13, 2000, apparently secondary to his refusal to accept assistance (P. Ex. 59, at 3); and on December 27, 1999, after the resident's hands slipped on a transfer pole that had been installed near his bed for his use in transferring from his bed to his wheelchair ( Id.). Records provided by Petitioner also reflect that he fell on or around June 6, 2000 (after he attempted to get out of bed to sit in his wheelchair), after which he was moved to a room directly across from the nurse's station, which Petitioner deemed successful as of June 21, because he was no longer making attempts to transfer himself. P. Ex. 59, at 1-2. The Form 2567 from the June 2000 revisit survey contained no reports of further falls. In its brief CMS referred to 15 falls since R35's admission in July 1998. Only the circumstances of the alleged deficiency finding of which Petitioner was given notice via the Form 2567 are germane to my review. Moreover, for the reasons in my discussion of R35, evidence of falls beyond those addressed in the Form 2567 would not change my determination. 8. While a CMS witness discussed restraints and the legal standards applicable to their use, at no time did CMS argue that the facility should have restrained this resident against his will in order to keep him from continuing to attempt to transfer himself and pick up objects without requesting assistance. Tr. at 371. 9. As I noted in the discussion of the May survey, section 483.20(d), cited in the Form 2567 and the parties' submissions as the basis for this deficiency finding, was redesignated as section 483.20(k) in December 1997. 62 Fed. Reg. 67,174, 67,211 (1997). 10. While the Form 2567 states that this information relates to R101, it appears that this was an error and that R100 was the intended resident, because the information reported in the Form 2567 corresponds to records relating to R100, and the summary for this f-tag identifies R100 as the only resident for whom this alleged deficiency was identified. HCFA Ex. 7, at 1; HCFA Ex. 10, at 24, 26. | |