Department of Health and Human Services DEPARTMENTAL APPEALS BOARD Civil Remedies Division | |
IN THE CASE OF | |
Beechwood Sanitarium, |
DATE: October 3, 2001 |
- v - |
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Centers for Medicare &
Medicaid Services.
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Docket
No.C-99-582 Decision No. CR821 |
DECISION | |
DECISION I sustain the determinations of the Center for Medicare & Medicaid Services (CMS, formerly known as the Health Care Financing Administration, or HCFA) to impose remedies against Petitioner, Beechwood Sanitarium, consisting of the following:
I. Background Petitioner is a long term care facility located in
Rochester, New York. Petitioner participated in Medicare and in the New
York State Medicaid program. Its participation in these programs was
governed by relevant sections of the Social Security Act (Act) and by
participation requirements that are stated at 42 C.F.R. Part
483. Petitioner was surveyed on several occasions in 1999 by
surveyors employed by the New York State Department of Health, Division of
Health Care Standards and Surveillance (New York State survey agency) in
order to determine Petitioner's compliance with federal participation
requirements. The 1999 surveys included surveys that were completed on the
following dates: April 22, 1999 (April 1999 survey); May 12, 1999 (May
1999 survey); and, June 14, 1999 (June 1999 survey). At each of these
surveys, the surveyors concluded that Petitioner was not complying
substantially with federal participation requirements. CMS concurred with
these determinations and imposed remedies against Petitioner consisting of
denial of payment for new Medicare admissions and termination of
Petitioner's participation in the Medicare program. Petitioner requested a hearing and the case was assigned
to me for a hearing and a decision. I held a hearing which included
receiving testimony by telephone on April 3, 2001 and in person in
Rochester, New York on April 17, 2001. At these sessions, I heard the
testimony of several witnesses either by telephone or in person. I also
received exhibits from the parties. I received into evidence exhibits from
CMS which are identified as HCFA Ex. 1 - HCFA Ex. 9 and HCFA Ex. 12 - HCFA
Ex. 47. I received into evidence exhibits from Petitioner which are
identified as P. Ex. 1 - P. Ex. 33 and P. Ex. 35 - 51. Many of the exhibits that each party offered consist of
transcript excerpts from a New York State hearing (State licensing
hearing) concerning Petitioner's license to operate a long term care
facility in that State. The State licensing hearing involved extensive
testimony by numerous witnesses. The parties to this case advised me that
the transcript of that hearing is approximately 3000 pages in length.
Initially, they requested that I receive the entire State licensing
hearing transcript into evidence. I denied that request on the ground that
it would be too cumbersome to do so. As an alternative to the parties'
request, I allowed them to offer excerpts from the State licensing hearing
transcript into evidence. I directed that each party identify any excerpt
that it wished to offer as an exhibit. The transcript excerpts that the
parties offered are in evidence as part of the "HCFA" exhibits and as part
of the "P." exhibits. Additionally, I received into evidence exhibits from
Petitioner which are identified by the letter "M." These exhibits were
previously identified and offered as evidence at the State licensing
hearing involving Petitioner's license as a nursing facility in the State
of New York. Each "M" exhibit also has a unique identifying number as in,
for example, M1818. As a courtesy to Petitioner, I permitted it to offer
"M" exhibits into evidence without re-identifying them. The "M" exhibits
that I admitted into evidence are recited in an exhibit list submitted by
Petitioner on July 16, 2001. Petitioner's (Beechwood) Exhibit List,
Revised 7/16/01. II. Issues, findings of fact and conclusions of law
The issue in this case is whether CMS is authorized to impose remedies against Petitioner including termination of Petitioner's participation in the Medicare program and denial of payment for new Medicare admissions.
I make findings of fact and conclusions of law (Findings)
to support my decision in this case. I set forth each Finding below as a
separately numbered heading. I discuss each Finding in detail. CMS must establish a prima facie case that Petitioner failed to comply substantially with one or more participation requirements in order to establish a basis to impose a remedy. If CMS does so, then the burden falls on Petitioner to rebut that prima facie case by the preponderance of the evidence. Hillman Rehabilitation Center, DAB No. 1611 (1997), aff'd, Hillman rehabilitation Center v. HHS, No. 98-3789 (GEV), slip op. at 25 (D.N.J. May 13, 1999). I have applied the Hillman standard to both the issue of whether CMS was authorized to terminate Petitioner's participation effective June 17, 1999 and whether CMS was authorized to deny Petitioner payment for new Medicare admissions in May 1999.
Prior to the hearing of this case, CMS moved for partial summary disposition as to certain issues of law. On September 5, 2000, I issued rulings which partially granted CMS's motion. Rulings on Motion by Health Care Financing Administration for Partial Summary Disposition, September 5, 2000 (Rulings). It is unnecessary for me to revisit those rulings here in detail. Rather, I am incorporating them into my decision. Briefly summarized, the rulings that granted CMS's motion in part are as follows:
I dismiss Petitioner's hearing request insofar as it
challenges findings of noncompliance that were made at the April 1999
survey. Dismissal of a hearing request is appropriate where a party has no
right to a hearing. 42 C.F.R. � 498.70(b). Petitioner has no right to a
hearing concerning the April 1999 survey findings because they are not the
basis for any remedy determination made by CMS. 42 C.F.R. �� 498.3,
498.5. As I discuss above at Part I of this decision, the New
York State survey agency conducted several surveys of Petitioner in 1999 -
including surveys that were conducted in April, May, and June of that year
- and found Petitioner not to be complying with participation requirements
at each of these surveys. Both CMS and Petitioner offered evidence and
arguments concerning the deficiency findings that were made at the April,
May, and June 1999 surveys. I received evidence which related to all of
these surveys although I observed that I might find ultimately that
evidence pertaining to the April 1999 survey was irrelevant to this case.
Tr. at 4 - 8. I now conclude that evidence relating to the April 1999
survey is irrelevant. Petitioner's compliance status as of the April 1999
survey is irrelevant to the question of whether CMS is authorized to
impose the remedies that it determined to impose. It is irrelevant to the
issue of whether CMS could impose the remedy of denial of payments for new
Medicare admissions in May 1999 because CMS is justified in imposing that
remedy based solely on the compliance findings that were made at the May
1999 survey. It is irrelevant to the issue of whether CMS could impose the
remedy of termination of participation in Medicare in June 1999 because
CMS is justified in imposing that remedy based solely on the compliance
findings that were made at the June 1999 survey. Indeed, the compliance
findings that were made at the May 1999 survey are also irrelevant to the
issue of whether CMS had authority to terminate Petitioner's participation
after the June 1999 survey. As I explained to the parties during the hearing, CMS's
authority to impose a remedy against a long term care facility - other
than a civil money penalty - arises from that facility's compliance status
as of the date that the remedy determination is made. Tr. at 4 - 8. If
Petitioner was not complying with one or more participation requirements
as of the June 1999 survey then CMS was authorized to terminate
Petitioner's participation in Medicare irrespective of Petitioner's
previous compliance status. See 42 C.F.R. � 488.456(b)(1).
Conversely, if Petitioner was complying with all participation
requirements as of the June 1999 survey then CMS would not be authorized
to terminate Petitioner's participation in Medicare regardless of
Petitioner's previous compliance status. The same analysis applies to
deciding the question of CMS's authority to impose a denial of payments
for new admissions against Petitioner after the May 1999 survey.
Petitioner's compliance status prior to the May 1999 survey has no bearing
on the question of CMS's authority to impose the remedy of denial of
payment for new admissions as of the May 1999 survey. Petitioner and CMS offered evidence and argument
concerning Petitioner's compliance status as of the April 1999 survey
because, according to them, it is relevant to establish Petitioner's past
history of compliance with participation requirements or CMS's motivation
for imposing remedies against Petitioner. But, neither Petitioner's
compliance history, nor CMS's motivation for imposing remedies are at
issue in this case. In this case, my authority is limited to hearing and
deciding the question of whether a basis exists to impose remedies against
Petitioner. 42 C.F.R. � 488.408(g). Whether such a basis exists depends on
Petitioner's compliance status as of the dates when CMS determined to
impose the two remedies that are at issue. It does not depend on
Petitioner's compliance history. Nor does it depend on CMS's motivation
for imposing remedies. Throughout this case Petitioner has argued that the
remedies that CMS determined to impose are the product of animus directed
against it by the New York State survey agency and by CMS. Petitioner
argues that events relating to the April 1999 survey evidence a pattern of
animus against it. But, the presence or absence of possible animus is
irrelevant to the issue of whether a basis exists to impose remedies. If
evidence establishes that Petitioner was not complying with participation
requirements as of the dates when remedies were imposed, then the
motivation of the agency or agencies involved in imposing those remedies
does not matter. Petitioner argues that, in fact, remedies were imposed
against it based on the findings of noncompliance that were made at the
April 1999 survey. However, the two remedies that Petitioner identifies as
being imposed as a consequence of the April 1999 survey - a State-directed
plan of correction and State-imposed civil money penalties - are remedies
that the New York State survey agency determined to impose and are not
remedies that CMS determined to impose. CMS imposed no remedies against
Petitioner based on the findings of noncompliance that were made at the
April 1999 survey. There is neither a basis in the Act or in regulations for me to provide Petitioner with a hearing so that it may challenge State-imposed remedies. The Act is the statutory source of authority for the Secretary of the Department of Health and Human Services (Secretary) to impose remedies against long term care facilities. The Act confers hearing rights on providers who challenge determinations made by the Secretary or CMS acting as the Secretary's delegate. Act, sections 1819(h), 1866(h)(2). The Act does not provide for hearings to challenge State survey agency determinations. Id.; Rulings at 2 - 3. The Secretary has implemented the Act with regulations at 42 C.F.R. Parts 483, 488 and 498. These regulations confer hearing rights on long term care facilities to challenge certain determinations that are made by CMS. 42 C.F.R. �� 498.3, 498.5. They do not confer hearing rights to challenge determinations that have been made by State survey agencies.
I must decide whether or not Petitioner failed to comply
substantially with any one of the 10 participation requirements that
Petitioner is alleged not to have complied substantially with in the
report of the June 1999 survey in order to decide whether CMS was
authorized to terminate Petitioner's participation in Medicare. HCFA Ex. 9
at 1 - 9, 11 - 14. Failure by Petitioner to comply substantially with even
one of those requirements provides CMS with authority to terminate
Petitioner's participation. Act, section 1866(b)(2); 42 C.F.R. �
488.456(b)(1)(i); Beverly Health and Rehabilitation - Spring Hill,
DAB No. 1696 (1999). The evidence in this case establishes that, as of the June
1999 survey, Petitioner manifested failures to comply substantially with
at least one participation requirement. Consequently, CMS was authorized
to terminate Petitioner's participation in the Medicare
program. Below I analyze Petitioner's failure to comply substantially with three of the participation requirements for which Petitioner was cited at the June 1999 survey. I find that Petitioner failed to comply substantially with each of these requirements. It is unnecessary for me to analyze Petitioner's compliance with the other seven participation requirements that are cited in the report of the June 1999 survey inasmuch as a finding of even one failure by Petitioner to comply substantially with a participation requirement justifies imposition of the remedy of termination of participation. Therefore, I make no findings - either favorable to Petitioner or to CMS - concerning the other seven participation requirements.
At Tag 309 of the report of the June 1999 survey, the New
York State survey agency surveyors alleged that Petitioner failed to
comply substantially with the requirements of 42 C.F.R. � 483.25. HCFA Ex.
9 at 2 - 3. This regulation requires a facility to provide to each of its
residents care and services that are necessary for that resident to attain
or maintain the highest practicable level of physical, mental, and
psychosocial well-being, in accordance with that resident's comprehensive
assessment and plan of care. The surveyors alleged that Petitioner failed
in two respects to comply with the requirements of the regulation. First,
Petitioner is alleged to have failed to provide ongoing assessments of the
pain being experienced by a resident who is identified in the survey
report as Resident No. 3. Second, Petitioner is alleged to have breached
aseptic technique in changing the dressing of a resident who is identified
in the survey report as Resident No. 7. CMS offered prima facie proof of Petitioner's failure to
provide care to Residents Nos. 3 and 7 in accordance with the standards
set forth in the regulation. Petitioner did not rebut this proof by a
preponderance of the evidence. I conclude that Petitioner's failure to
provide acceptable care to the two residents is sufficient evidence to
support the broader conclusion that, as of the June 1999 survey,
Petitioner was not complying substantially with the requirements of 42
C.F.R. � 483.25.
CMS offered evidence that Petitioner's staff failed to
assess Resident No. 3's ongoing complaints of pain, to bring these
complaints to the attention of the resident's physician, or to suggest
treatment alternatives to the resident's physician that might have given
the resident better relief than the care that had been prescribed for her.
The resident had been experiencing chronic low back pain for which she was
receiving medication and treatments with ice packs. HCFA Ex. 9 at 2. The
resident continued to complain of severe pain and, on two occasions
(including once, on June 10, 1999, when a surveyor observed the resident),
the resident was observed to be writhing in pain. Id. Both of these
episodes occurred in early June 1999. However, Petitioner's staff failed
to make any reassessments of the resident's complaints of pain after April
30, 1999 and failed to suggest to the resident's physician any possible
changes in the resident's treatment that might alleviate the resident's
pain. Id. The evidence which CMS offered of Petitioner's
noncompliance in the care it provided to Resident No. 3 is prima facie
proof that Petitioner failed to provide the resident with the care that
was needed to attain the highest possible level of physical and mental
functioning by the resident. More aggressive management by Petitioner's
staff of the pain that Resident No. 3 experienced would not necessarily
have given the resident greater relief from pain than the resident
experienced. But, Petitioner was obligated to at least attempt to obtain
the best possible pain management for the resident. The evidence offered
by CMS suggests that Petitioner's staff merely followed the resident's
physician's orders without assessing whether those orders provided
effective care for the resident. The potential for harm to the resident is
obvious. The resident might have experienced less pain had Petitioner's
staff assessed the efficacy of the treatment ordered by the resident's
physician and had it communicated its findings to the resident's
physician. Petitioner did not overcome this evidence of
noncompliance. Petitioner argues, primarily, that it was following the
orders given by Resident No. 3's treating physician and that it cannot be
faulted for complying with those orders. But, the issue here is not
whether Petitioner or its staff followed the physician's orders. What is
at issue here is whether Petitioner assessed the efficacy of the
medications and treatments that had been prescribed by the resident's
physician and communicated its findings to the physician. The staff's
professional obligations to the resident included performing ongoing
assessments of the resident's complaints of pain and communicating its
findings to the physician, along with suggestions for possible changes in
the resident's treatment, in order to maximize the resident's pain relief.
Petitioner did not prove that it did that. Petitioner also argues that the resident's treatment
record shows that its staff reacted promptly to the resident's complaints
of pain and that the resident, in fact, obtained relief from the
medication and ice packs that the staff administered to the resident. I do
not question the diligence of Petitioner's staff in providing prescribed
care to Resident No. 3. But, notwithstanding Petitioner's arguments, this
resident's record shows that the resident continued to experience episodes
of severe pain in early June 1999, some of which left her writhing in
pain, more than a month after Petitioner's staff wrote a plan of care for
the resident. The resident's pain was sufficiently severe that, at times,
it interfered with her appetite or prevented her from participating in
activities. HCFA Ex. 40 at 11 - 16. Yet, Petitioner's staff failed to
consider the possibility that better or additional treatment might be
provided to the resident. Finally, Petitioner asserts that CMS seeks to impose on it
a duty to second guess the care ordered by the resident's treating
physician. It argues that, in Beverly Health & Rehabilitation -
Spring Hill, DAB CR553 (1998), I found that a facility did not have
the duty to second guess the diagnosis made by a resident's
physician. I disagree with this analysis. In Spring Hill, CMS
(then HCFA) argued that a facility's staff should have found that a
physician's diagnosis of a resident's medical condition was incorrect and
should have challenged the care regime ordered by the physician. I found
that the facility's non-physician staff did not have the duty to make its
own diagnosis of the resident's illness in order to challenge the
physician's subjective medical judgment. This situation is clearly
distinguishable. CMS has not suggested in this case that Petitioner's
staff should have challenged the physician's diagnosis of the resident's
condition. All that Petitioner's staff was required to do here was to make
observations and assessments of the resident's condition and communicate
the findings to the physician. Serving as a physician's eyes and ears is
an essential element of Petitioner's duty to its residents under 42 C.F.R.
� 483.25.
CMS offered evidence to show that Resident No. 7 was
treated in a manner that contravened instructions given by the resident's
treating physician. The resident suffered from multiple wounds and
injuries to her lower extremities as a consequence of peripheral vascular
disease and of surgery performed to treat the resident's condition. HCFA
Ex. 9 at 2 - 3. The resident's treating physician prescribed that the
resident's wounds be treated with daily changes of sterile dressings.
Id. at 2. On June 10, 1999, a surveyor observed Petitioner's staff
attempting to change the resident's dressings. The surveyor noted that the
staff failed to position the resident properly in order to change the
dressings. Id. The surveyor then observed that the staff allowed
the resident's exposed foot to rest directly on the metal footrest of the
resident's wheelchair. Id. When the surveyor questioned this
alleged breach of aseptic technique, Petitioner's staff responded by
placing the resident's foot on a pillow taken from the resident's bed,
thereby allegedly placing the resident's foot in direct contact with the
non-sterile pillow. Id. at 2 - 3. The evidence that CMS offered concerning Resident No. 7 is
prima facie proof of a failure by Petitioner to provide care that
maximized the resident's physical well-being. The resident's physician
instructed Petitioner's staff to provide care that minimized the risk that
the resident's wounds might become infected. The evidence offered by CMS
shows that the staff did not follow these instructions. The evidence shows
a potential for more than minimal harm to the resident because the risk
that the resident might suffer infection was heightened by the staff's
failure to follow the physician's instructions. Petitioner did not overcome this prima facie case of
failure to comply substantially with a participation requirement.
Petitioner argues, first, that its staff did not breach aseptic technique
in changing the resident's dressings. It asserts that the evidence
obtained by CMS shows only that the resident's heel came into
contact with possibly septic surfaces when, in fact, the dressing changes
were being made to the resident's toes. I do not find this
argument to be persuasive. Petitioner offered evidence to prove that only
the resident's heel came into contact with the nonsterile pillow. But,
Petitioner did not rebut evidence that the resident's entire foot came
into contact with the possibly septic surface of the metal footrest of the
resident's wheelchair. Petitioner relies on the testimony of Donna Richardson,
its former Director of Nursing. Tr. at 191 - 192; 223 - 224. Ms.
Richardson testified that it would not be a breach of sterile technique to
rest the resident's heel on a pillow while changing a dressing on the
resident's toes. Id. at 223 - 224. However, Ms. Richardson was not present while the dressing
was being changed and has no first hand knowledge of what happened. And,
in fact, her testimony was predicated on only some of the surveyor's
observations. As a consequence, it does not answer completely the
observations and allegations that were made by the surveyor. The surveyor
observed Petitioner's staff placing the resident's exposed foot -
and not just the resident's heel - on the non-sterile metal surface of a
wheelchair prior to changing the resident's dressing. HCFA Ex. 9 at 2.
Thus, the surface of the resident's foot, which included areas that were
wounded, was in contact with a potentially septic surface prior to the
surveyor's intervention. It was only after the surveyor intervened that
Petitioner's staff placed a pillow under the resident's heel.
Id. Second, Petitioner argues that CMS failed to establish
even a prima facie case of a potential for more than minimal harm
resulting to Resident No. 7 from Petitioner's use of non-sterile technique
in treating the resident's wounds. It cites as authority my decision in
Mediplex of Massachusetts, d/b/a Randolph's Crossings Nursing
Center, DAB CR584 (1999), as support for its argument. It argues that
in Mediplex I found that sterile technique was not necessary to
treat a wound. I find the Mediplex decision to be distinguishable
from this case. I based my decision in Mediplex on the unique facts
of that case. Here, the facts differ and my conclusions about the
potential for harm resulting from Petitioner's conduct are also different
than my findings in Mediplex. I did not find in Mediplex that all wounds may be treated in compliance with regulatory requirements by a facility's staff using non-sterile technique. In Mediplex, the resident's wound had been closed with sutures. The preponderance of the evidence in that case was that sterile technique was not required to clean the resident's closed wound. By contrast, in the present case the resident had an open and draining wound on her foot and the physician had prescribed sterile dressings. HCFA Ex. 9 at 2.
At Tag 314 of the report of the June 1999 survey, the New
York State survey agency surveyors alleged that Petitioner did not comply
substantially with the requirements of 42 C.F.R. � 483.25(c). This
regulation requires, at 42 C.F.R. � 483.25(c)(2), that a facility provide
necessary treatment and services to a resident who has pressure sores to
promote healing, prevent infection, and prevent new pressure sores from
developing. The surveyors alleged that Petitioner failed in three respects
to provide care that satisfied the requirements of the regulation. As
evidence, they cited Petitioner's treatment of residents identified as
Resident No. 12, Resident No. 1, and Resident No. 3. I note, however, that
while CMS made posthearing arguments concerning the care that Petitioner
gave to Resident No. 12 and Resident No. 1, it did not argue that
Petitioner's care of Resident No. 3 was deficient. See CMS's Post
Hearing Brief at 51 - 54. The evidence that CMS offered concerning the care that Petitioner gave to Resident No. 12 and to Resident No. 1 is prima facie proof that Petitioner was not providing care to these two residents in substantial compliance with the requirements of the regulation. I find that Petitioner failed to meet its burden of rebutting this prima facie proof. The failure by Petitioner to provide care to two of its residents that met regulatory requirements is sufficient for me to find an overall failure by Petitioner to comply with the requirements of 42 C.F.R. � 483.25(c).
CMS offered evidence to show that Petitioner's staff
disregarded treatment directives that were intended to protect Resident
No. 12 against the development of pressure sores. Additionally, it offered
evidence to show that the staff was unaware that the resident had
developed new pressure sores. Resident No. 12 had developed pressure sores in the past
while residing at Petitioner's facility. HCFA Ex. 9 at 3. Treatments were
administered to the resident for his sores. These were discontinued on
June 2, 1999 because the sores had healed. Id. However, the
resident's treatment plan continued to call for the resident to wear
lamb's wool booties while the resident was in bed in order to protect the
resident's feet against the possible development of new sores. Id.
On June 10, 1999 a surveyor observed the resident lying on his bed,
continuously, for a two hour period while wearing shoes and socks.
Id. The booties were on the resident's bed near the resident during
this time period. The surveyor asked that the resident's shoes and socks
be removed so that the resident's feet could be observed. Observation
revealed reddened areas to both heels. Id. Later, on June 10, 1999,
the surveyor observed that the resident had developed Stage II pressure
sores on both of his buttocks. Id. On the following day, the
surveyor observed the resident again being placed in bed on his back and
buttocks for a period of about one hour. Id. Petitioner's staff
again failed to place protective booties on the resident's feet. The
facility's charge nurse indicated that she had been unaware that the
resident had developed new pressure sores. Id. The foregoing evidence establishes a prima facie case of
Petitioner's failure to comply with 42 C.F.R. � 483.25(c)(2). It shows
that Petitioner failed to carry out routine precautions to protect the
resident's feet against the development of pressure sores. It shows also
that Petitioner's staff was not attentive to the resident's condition and
allowed him to remain in the same position for relatively lengthy periods
of time. And, it shows that the staff was unaware that the resident had
developed new sores. The potential for harm resulting from these failures
to provide routine care is clear. Resident No. 12 was highly susceptible
to developing pressure sores. Yet, the prima facie evidence offered by CMS
shows that Petitioner's staff failed to provide care which was necessary
to prevent new sores from developing. Petitioner did not rebut this evidence. Petitioner
discusses at considerable length all of the efforts that its staff engaged
in to protect the resident against developing pressure sores. Petitioner's
Post-Hearing Brief at 12 - 14. But, it fails to explain why, on the
occasions observed by the surveyors, its staff had failed to implement
some of these measures. Petitioner offers no explanation for the resident
being allowed to lie in bed with his shoes on and without the protection
of lamb's wool booties. Nor does Petitioner explain why the resident was
allowed to lie or sit in one position for relatively lengthy periods of
time. Petitioner argues also that the resident's treating
physician was satisfied with the level of care that was being provided to
Resident No. 12. But, as satisfied as the physician may have been with the
general level of care that Petitioner's staff gave to the resident, she
did not rebut the specific allegations that, on June 10 and 11, 1999,
staff was deficient in providing prescribed care to the
resident. Finally, Petitioner argues that any pressure sores that the resident developed were an unavoidable consequence of the resident's condition. However, CMS has not alleged that the resident developed avoidable pressure sores. See 42 C.F.R. � 483.25(c)(1). The allegations here are that Petitioner's staff failed to carry out prescribed preventive measures and thus failed to comply with the care requirements of 42 C.F.R. � 483.25(c)(2).
The evidence offered by CMS is that Resident No. 1 had
persistent pressure sores on the coccyx and the left foot. HCFA Ex. 9 at 3
- 4. The resident complained of discomfort resulting from the treatment
that Petitioner's staff administered for the sore on the resident's
coccyx. However, Petitioner's staff made no revisions to the resident's
care plan to address the continuing pressure sore in the coccyx area and
did not assess the resident's left foot to determine the efficacy of
treatment. Id. at 4. This evidence establishes a prima facie case that
Petitioner did not provide necessary treatment and services for Resident
No. 1's pressure sores. Given that the sores were not improving,
Petitioner was under an obligation to explore treatment alternatives that
might promote healing. The prima facie evidence is that Petitioner failed
to do so, resulting in a potential for more than minimal harm to the
resident. Petitioner argues that Resident No. 1 was at high risk for
developing pressure sores, thereby suggesting that any sores that the
resident may have developed were unavoidable. However, as is true with
Resident No. 12, CMS is not alleging that the resident developed avoidable
sores. The allegation is that Petitioner did not do all that it should
have done to manage the sores that the resident had developed. Petitioner argues also that the resident's condition had
not changed substantially, thereby suggesting that it was unnecessary for
Petitioner's staff to consider new treatment approaches for dealing with
the resident's pressure sores. Petitioner's Post-Hearing Brief at 14 - 15.
The fact that the resident's condition may not have changed over time does
not justify Petitioner's failure to consider modifications to the
resident's care plan. A facility must do more than just maintain the
status quo for a resident who suffers from pressure sores. A facility is
obligated to promote healing. What Petitioner does not address is the failure of Petitioner's staff to assess Resident No. 1's skin condition after May 18, 1999 in spite of lack of improvement in the resident's condition. However, this is the essence of CMS's allegation of noncompliance by Petitioner with the requirements of 42 C.F.R. � 483.25(c)(2) in providing care to the resident.
At Tag 324 of the report of the June 1999 survey, the New
York State survey agency surveyors allege that Petitioner failed to comply
substantially with the requirements of 42 C.F.R. � 483.25(h)(2). This
regulation requires that a facility ensure that each of its residents
receives adequate supervision and assistance devices to prevent accidents.
The surveyors alleged that Petitioner failed to comply with the
requirements of the regulation in providing care to residents who are
identified as Residents Nos. 8, 9,15, 16, and 17. HCFA Ex. 9 at 5 -
7. As I discuss below, CMS established a prima facie case of
substantial noncompliance by Petitioner with the regulation's requirements
in the care that Petitioner gave to Residents Nos. 9, 15, 16, and 17.
Petitioner did not establish by a preponderance of the evidence that CMS's
allegations with respect to these four residents are incorrect. CMS did
not establish a prima facie case of noncompliance with the regulation's
requirements in the care that Petitioner gave to Resident No. 8. However,
I conclude that the failure by Petitioner to provide adequate care to
Residents Nos. 9, 15, 16, and 17 is sufficient to establish an overall
failure by Petitioner to comply with the requirements of 42 C.F.R. �
483.25(h)(2). The regulation does not impose a strict liability standard
on a facility. Accidents happen at facilities despite the best and most
prudent measures that may be taken to avoid them. The mere occurrence of
an accident, therefore, is not necessarily a basis for finding a failure
to comply with the requirements of 42 C.F.R. � 483.25(h)(2). However, the
evidence in this case establishes that, for each of the residents that I
discuss, Petitioner should have taken steps that were reasonably necessary
to forestall the occurrence of forseeable accidents but failed to do so. I
find it to be irrelevant that in most of these instances accidents did not
occur. What matters here is the potential for harm. Petitioner's failure
to take reasonable precautions to protect some of its residents placed
them at risk of injury.
I do not find that CMS established a prima facie case that
the care that Petitioner gave to Resident No. 8 did not comply
substantially with the requirements of 42 C.F.R. � 483.25(h)(2). The
regulation requires that a facility give its residents supervision and
assistance devices that are sufficient to prevent accidents. But, the
report of the June 1999 survey does not allege that Petitioner failed to
provide such care for Resident No. 8. Rather, the report alleges that
Petitioner failed adequately to document whatever care it
provided to the resident. HCFA Ex. 9 at 6. Inadequacy of documentation of
care - as opposed to inadequacy of care - is not necessarily a basis for a
failure to comply with the requirements of 42 C.F.R. �
483.25(h)(2).
The evidence offered by CMS is that Resident No. 9 was at
a very high risk for choking and aspiration of food. HCFA Ex. 9 at 6 - 7.
The resident suffered from dysphasia, but also was wearing a rigid
cervical collar as a consequence of a suffering a cervical spine fracture.
Id. The resident's physician ordered that the resident be fed on a
one on one basis. Id. On June 10, 1999, a surveyor discovered the
resident alone in her room while attempting to drink a cup of coffee.
Id. at 7. The foregoing evidence is prima facie proof of a failure
by Petitioner to provide adequate supervision of Resident No. 9.
Petitioner had a duty to supervise the resident while she attempted to eat
and drink. Evidence introduced by CMS shows that, notwithstanding this
duty, Petitioner left the resident unsupervised. The risk of harm to the
resident is evident. The resident might choke if allowed to eat or drink
unsupervised. Petitioner asserts that Resident No. 9's eating and
drinking was under the care of a speech pathologist. Petitioner argues
that the speech pathologist concluded that the resident could consume
thickened liquids without supervision and that the coffee that the
resident was attempting to drink on June 10, 1999 was thickened.
Therefore, according to Petitioner, it did not breach its duty to
supervise Resident No. 9. Petitioner's Post-Hearing Brief at
23. I do not find this argument to be persuasive. Petitioner
has not denied that there was a physician's order that the resident be fed
one on one. Petitioner has offered no evidence to show that the physician
modified this order or that the physician deferred to a speech pathologist
in determining how the resident was to be fed. Moreover, the speech pathologist did not tell Petitioner's
staff that it was permissible to allow the resident to consume thickened
liquids without supervision. The speech pathologist said only that members
of the resident's family might feed the resident with thickened liquids.
But the speech pathologist never suggested that Petitioner's staff could
absent themselves from the resident's presence while this
occurred. The speech pathologist's report was written to address a
specific problem. M2087. Members of the resident's family were feeding the
resident free-flowing liquids despite the fact that the resident's
physician had ordered the resident to be fed with honey thickened liquids
and also despite the fact that the family had been requested not to feed
the resident. The pathologist concluded that it would be acceptable if the
resident's son fed the resident honey thickened liquid but cautioned that
only Petitioner's staff should feed the resident free-flowing liquids.
Id. Specifically, the speech pathologist says:
M2087. I read the speech pathologist's report as addressing only what family members might be allowed to do for the resident. The report neither states nor suggests that Petitioner's staff could absent itself from the room while a family member attempted to feed the resident. Indeed, the thrust of the report is to express concern that family members might inadvertently cause the resident to suffer harm if they attempted to feed her without supervision.
The evidence offered by CMS shows that Resident No. 15 had
difficulty walking secondary to severe cellulitis in her right leg. This
put her at risk for falls. Petitioner's staff acknowledged the resident's
gait problems and the attendant risk for falls. The resident's
susceptibility for falling is recorded in the resident's care plan. HCFA
Ex. 9 at 5. The resident's care plan stated that the resident should walk
with assistance by one of Petitioner's staff while using a walker.
Id. During the May 1999 survey Resident No. 15 complained to a
surveyor in the presence of a member of Petitioner's nursing staff that,
during the previous night, she had almost killed herself while attempting
to go to the bathroom by herself. HCFA Ex. 9 at 5. During that discussion
the nurse observed that the resident should not attempt to ambulate on her
own. However, on June 5, 1999 the resident sustained a fall while alone in
her room at night. The evidence presented by CMS concerning Resident No. 15
is prima facie proof that Petitioner did not provide the resident with
adequate supervision or assistance devices to prevent the resident from
sustaining falls. It shows that Petitioner's staff knew that the resident
had severe gait problems and yet permitted the resident to ambulate
unassisted at night. The evidence shows that the consequence of the
staff's lax supervision of the resident was that the resident sustained a
fall and was injured. HCFA Ex. 9 at 5. Petitioner offers several arguments in response to this
evidence. I find that they do not rebut the prima facie case of failure to
comply with the requirements of 42 C.F.R. � 483.25(h)(2). First,
Petitioner asserts that it properly investigated and reported the events
related to the resident's June 5, 1999 fall. But these assertions do not
address the question of Petitioner's failure to provide adequate
supervision of or assistance devices to the resident. Second, Petitioner asserts that the resident was, in fact,
given supervision consistent with her care plan. I do not find this
contention to be persuasive. The issue here is not whether Petitioner
complied with the resident's care plan. The issue is whether Resident No.
15 was supervised adequately or provided with necessary assistance
devices. The resident was vulnerable to falls when she attempted to
ambulate without supervision. She should not have been permitted to
ambulate alone at night regardless what her care plan said. I note,
however, that the resident's care plan does not suggest that the resident
should be allowed to ambulate while unsupervised. Third, Petitioner argues that the resident in fact had
acquired a relatively competent gait. It notes that, by June 5, 1999, the
resident had progressed to the point where she could ambulate up to 80
feet with the aid of a walker while under supervision. Petitioner
apparently suggests by this that the resident no longer needed close
supervision as of June 5, 1999 and that the accident she sustained on that
date was not forseeable. I am not persuaded by this argument. The fact is
that even on June 5, 1999, the resident still was being provided
supervision while she attempted to walk. There is nothing in the
resident's record that Petitioner has pointed to which shows that the
resident had progressed to the point where she could ambulate
unsupervised. Indeed, the excerpt from the resident's record relied on by
Petitioner proves the contrary to be true. M2080. Finally, Petitioner argues that the resident wanted to be
independent. Petitioner asserts that providing the resident with a bed
alarm which would have alerted Petitioner's staff when the resident got
out of bed at night or a bedside commode which would have minimized the
resident's need to ambulate at night would not have been productive in
light of the resident's desire. But, this argument is belied by the fact
that, barely two weeks prior to sustaining her fall on June 5, 1999, the
resident had complained that she was not getting assistance at night when
she needed to use the bathroom. HCFA Ex. 5 at 9. Moreover, there is
nothing in the resident's record to suggest that the resident had
progressed to the point that she should attempt to ambulate without
supervision and assistance. Indeed, on May 20, 1999 a member of
Petitioner's staff commented that the resident should not attempt to
ambulate alone. Id.
CMS presented evidence to show that both Residents Nos. 16
and 17 were left alone by Petitioner's staff while they were being bathed
in a device that is known as a Century tub. HCFA Ex. 9 at 5 - 6. A Century
tub is a specialty tub that is designed to bathe disabled individuals.
HCFA Ex. 12 at 1245 - 1246. It is approximately 2'7" deep, 28 inches wide,
and 58 inches in length. Id. at 1246. Individuals who are bathed in
the tub are put in a special seat and lifted hydraulically into the tub.
Id. Individuals who are bathed in the tub wear a seat belt in order
to reduce the dangers from sliding while in the tub. Id. at 1248.
There is a risk of danger to individuals who are placed in a Century tub
and left unsupervised. Id. Potential risks to unsupervised
individuals include drowning. Id. The evidence offered by CMS is prima facie proof that
Petitioner failed to provide adequate supervision of Residents Nos. 16 and
17 to prevent these residents from sustaining accidents while they were in
the Century tub. Both of these residents were frail, infirm individuals
who were left alone by Petitioner's staff while partially submerged in the
Century tub. From this evidence I infer that both of the residents were at
risk for drowning while they were left in the tub
unsupervised. Petitioner offers several arguments in response to CMS's
prima facie evidence. First, it argues that the design and standard use of
a Century tub is such that it does not present any appreciable risk of
accidents to individuals while they are in the tub. Petitioner's
Post-Hearing Brief at 19. This argument is unsupported and is in fact
belied by the manufacturer's manual for the Century tub which lists
numerous risks to individuals while they are in the tub. M1921 at 1 - 14.
Moreover, it is irrelevant. Leaving residents unsupervised while in the
tub is not "standard use" of the tub. Second, Petitioner asserts that the manufacturer's manual
for the Century tub does not suggest that a hazard exists when a resident
is left alone in the tub. Petitioner's Post-Hearing Brief at 19;
see M1921 at 1 - 14. That may be true, but it also is irrelevant. A
careful reading of the manufacturer's manual shows that it does not
envision a circumstance where an individual would be left alone while in
the tub. It is clear from the manual that the tub presents a host of risks
to an unsupervised individual. Third, Petitioner attacks the credibility of the surveyor
who observed Resident No. 17 being left alone in the Century Tub.
Petitioner's Post-Hearing Brief at 21. It points to a number of apparent
discrepancies in that surveyor's accounts of what she observed as proof
that the surveyor's overall testimony was not credible. However,
Petitioner does not deny that Resident No. 17 was left alone for
some period of time. Whether that was for five minutes as was
attested to by the surveyor, or for some other amount of time, the fact is
that Petitioner's staff left Resident No. 17, a 97 year old demented
individual with impaired vision, alone in a tub that left him at least
partially submerged. The risks resulting from that exposure are obvious
and Petitioner has not shown how the actions of its staff did not consist
of inadequate supervision of the resident. Finally, Petitioner argues that there was no hazard in
leaving Resident No. 16 alone in the Century tub because the resident was
sufficiently capable that he could be left "safely alone" for a brief
period. Petitioner's Post-Hearing Brief at 21 - 22. I do not find this
argument to be persuasive. As I discuss above, the manufacturer's manual
for the Century tub makes it plain that this is an extremely hazardous
piece of equipment unless operated precisely according to the
manufacturer's instructions. Leaving a resident alone for even a short
period while partially submerged in water is not "safe".
As I discuss above, at Finding 2, CMS may impose the
remedy of denial of payment for new Medicare admissions against a long
term care facility after a survey in which the facility is found not to be
complying substantially with only one federal participation requirement.
The report of the May 1999 survey cites Petitioner for not complying
substantially with 10 separate participation requirements. HCFA Ex. 8. I
conclude that Petitioner failed to comply substantially with requirements
that are cited in the survey report. Below I discuss Petitioner's failure to comply substantially with two of the requirements that are cited in the May 1999 survey report. I do not make findings that are either favorable or unfavorable to CMS or Petitioner concerning the remaining eight alleged deficiencies. I do not address Petitioner's compliance or noncompliance with the other eight requirements that are cited in the report because it is unnecessary that I do so.
At Tag 157 of the report of the May 1999 survey, the New York State survey agency surveyors allege that Petitioner did not comply substantially with the requirements of 42 C.F.R. � 483.10(b)(11). This regulation requires that a long term care facility immediately inform a resident; consult with that resident's physician; and, if known, notify the resident's legal representative or an interested family member when there is:
A "transfer" of a resident is defined at 42 C.F.R. �
483.12(a)(1) to mean movement of a resident to a bed outside of a facility
whether the bed is in the same physical plant or not. CMS offered evidence to establish that a resident who is
identified in the May 1999 survey report as Resident No. 3 sustained a
fall on May 5, 1999 during which the resident hit her head. HCFA Ex. 8 at
2. A physician's assistant was notified of the event and the staff was
directed to monitor her. At 3:00 a.m. on May 6, 1999, the resident was
administered Tylenol in response to her complaint of a headache.
Id. Later on the morning of May 6, 1999, the resident was sent to a
hospital by the physician's assistant for evaluation of an elevated
temperature and complaints of abdominal pain. Id. On May 8, 1999, a
surveyor observed a family member arrive at Petitioner's facility to visit
the resident. The family member was observed to verbalize that he was
unaware of the resident's transfer to a hospital and to express concern at
not being notified. The surveyors concluded that there was no evidence in
the resident's record that the family member had been notified, either of
the resident's fall, or of the change in the resident's condition which
required that the resident be transferred to a hospital.
Id. The above-described evidence, if unrebutted, is prima
facie evidence of a failure by Petitioner to comply with the requirements
of 42 C.F.R. � 483.10(b)(11)(A) and (D). The regulation imposes a duty on
a long-term care facility to notify a resident's family when there is an
accident involving a resident that is sufficiently serious as potentially
to require physician intervention or when the facility transfers the
resident outside of its premises. Here, the prima facie evidence is that
Resident No. 3 sustained an accident of sufficient severity so as to
require family notification. The evidence also establishes that
Petitioner, on its own volition, transferred the resident. In neither case
did the resident's family receive the required notification. Petitioner offers three arguments in response to this
evidence. I do not find them to be persuasive. First, Petitioner asserts that the individual who made the
findings was not a certified surveyor. Therefore, according to Petitioner
the allegations of noncompliance contained in the May 1999 survey report
should be precluded from consideration. Petitioner's Post-Hearing Brief at
37. I do not find this argument to be persuasive because the issue is not
whether the surveyor was qualified but the accuracy of the findings that
are stated in the May 1999 survey report. If the findings in the report
are accurate then they are prima facie evidence of noncompliance by
Petitioner with participation requirements. Second, Petitioner asserts that the regulation establishes a high threshold for required notification and that, therefore, the word "injury" in 42 C.F.R. � 483.10(b)(11)(A) should be interpreted narrowly. Petitioner asserts that Resident No. 3 was not, in fact, "injured" when she fell and hit her head. Therefore, according to Petitioner, it had no duty to inform the resident's family of the accident. Petitioner bases its argument as to how the word "injury" should be interpreted on the language contained in 42 C.F.R. � 483(10)(b)(11)(B). This subsection requires that notification be made where there is:
Petitioner reasons that an "injury" under subsection A
must be as severe as a "significant change" in a resident's condition to
warrant notification of the resident's family. I disagree with this analysis. The two subsections were
written to address different circumstances and were not intended to be
read as requiring the same levels of harm to the resident as a threshold
for notification. "Accidents" are events which may be due to negligence or
misfeasance on the part of a facility. It is reasonable to require family
notification of even a slight injury resulting from an accident because
the facility should be apprised of any event where the facility may be at
fault in causing potential harm. Thus, the regulation makes it plain that
a resident sustains an injury that requires notification any time that the
injury is sufficiently severe as potentially to require physician
notification. The standard for notification under 42 C.F.R. �
483.10(b)(11)(B) are more stringent than under 42 C.F.R. �
483.10(b)(11)(A) because subsection (B) addresses an entirely different
circumstance than an accidental injury. It would be unreasonable to
require a facility to notify a resident's family of minor changes in a
resident's medical condition because that would impose an unduly onerous
requirement on the facility. A resident's medical condition may be
expected to fluctuate from day to day even where the facility is providing
the best possible care to the resident. The injury sustained by Resident No. 3 was sufficient
injury to trigger the notification requirement. The undisputed evidence is
that the resident struck her head during a fall and experienced at least
some pain (a headache). As a consequence of that injury Petitioner's staff
notified a physician's assistant. Finally, Petitioner argues that the failure to notify the resident's family of the transfer of the resident was an isolated incident that did not rise to the level of a failure to comply substantially with participation requirements. I do not disagree with Petitioner that the evidence pertaining to Tag 157 shows an isolated failure by Petitioner to comply with participation requirements. But, the failure in this instance was not a simple error by Petitioner's staff that caused no potential for harm. The resident was absent from the facility for more than two days before a relative discovered the absence. It is reasonable to infer that the failure to notify would have continued had the family member not complained. It is also reasonable to infer that during this period the resident was in the hospital isolated from her family. There was a substantial potential for the resident to suffer emotional harm during the hospitalization.
At Tag 281 of the report of the May 1999 survey, the New
York State survey agency surveyors allege that Petitioner failed to comply
substantially with the requirements of 42 C.F.R. � 483.20(k)(3)(i). HCFA
Ex. 8 at 2 - 10. This regulation requires that services provided or
arranged by a long term care facility must meet professional standards of
quality. The surveyors found that Petitioner failed to satisfy the
requirements of the regulation in providing care to nine residents. These
residents are identified in the survey report as Residents Nos. 5, 8, 9,
12, 16, 22, 23, 24, and 28. However, CMS offered evidence and argument as
to only six of these residents. These are Residents Nos. 23, 5, 28, 9, 8,
and 22. CMS's Post Hearing Brief at 26 - 34. The survey report mis-cites the section of the regulation
which is at issue as 42 C.F.R. � 483.20(d)(3)(i). Petitioner
argues that the allegations of noncompliance are deficient on their face
inasmuch as the specific fact allegations made at Tag 281 have nothing to
do with that section of the regulation. It argues, furthermore, that to
allow CMS to argue now that the surveyors and it meant to cite to 42
C.F.R. � 483.20(k)(3)(i) would be an amendment to the allegations of
noncompliance that is prejudicial to Petitioner. I have often ruled that CMS will not be permitted to
change its allegations of noncompliance without giving a facility adequate
notice of its intent to do so. Here, however, the notice that was given to
Petitioner was certainly adequate to inform it that what is at issue under
Tag 281 was Petitioner's compliance with the requirements of 42 C.F.R. �
483.20(k)(3)(i). Although the survey report cites to the wrong section of
the regulation it quotes verbatim from 42 C.F.R. � 483.20(k)(3)(i) as the
operative regulatory language that Petitioner allegedly contravened. HCFA
Ex. 8 at 2 - 3. Petitioner would know explicitly what CMS was contending
it failed to comply with by reading the text of the survey report. I note
also that, in the codified regulation, there are no subparts to 42 C.F.R.
� 483.20(d). Petitioner would have been disabused of any confusion about
what was being alleged simply by reading the regulation as it was
codified. As I discuss below, CMS offered evidence sufficient to establish a prima facie case that Petitioner did not provide care which met professional standards of quality. Petitioner did not overcome by a preponderance of the evidence CMS's prima facie case of noncompliance with the requirements of 42 C.F.R. � 483.20(k)(3)(i). The evidence establishes that, in the cases of five of the six residents whose care is cited under Tag 281, Petitioner's staff did not provide care that met professional standards of quality. That is sufficient to establish a pattern of deficient care by Petitioner's staff and a potential for more than minimal harm to residents of Petitioner.
CMS offered evidence to show that Petitioner's staff
failed to comply with the requirements of New York State law in
documenting the disposition of a tablet of Darvocet N-100, a controlled
substance. Resident No. 22 had a prescription for the administration of
Darvocet N-100. HCFA Ex. 8 at 9. The evidence offered by CMS is that, on
May 7, 1999, a nurse made a record that one tablet of the medication was
"wasted." The evidence shows, however, that Petitioner's staff failed to
provide a second signature on the record as is required by law. Id.
CMS offered additional evidence to show that Petitioner's staff failed to
document what happened to the wasted tablet of medication. I am not persuaded that this evidence is prima facie evidence of a failure by Petitioner's staff to provide care that met professional standards of quality. CMS has not offered evidence addressing the seriousness, if any, of Petitioner's staff's alleged failure to comply with New York State law by not providing a second signature on the resident's mediation administration record. Nor has CMS provided any evidence to show that the resident actually needed the missing medication. The evidence shows that the medication was prescribed "p.r.n." (as needed). CMS did not offer evidence that the resident needed the dose of medication in question.
The evidence offered by CMS concerning Resident No. 23 is
that the resident was admitted to Petitioner's facility for restorative
therapy suffering from a number of medical problems including a pelvic
fracture, bilateral knee fractures, and dementia. HCFA Ex. 8 at 3. The
resident came to the Petitioner's facility wearing an indwelling Foley
catheter. Id. The physician's order for the resident's care, dated
May 6, 1999, stated that the catheter may be removed after three to four
days. However, the catheter remained in place as of May 12, 1999, six days
after the resident entered Petitioner's facility. In an interview with a
member of Petitioner's nursing staff on May 12, 1999, that employee stated
that she had just become aware of the physician's order concerning the
catheter. The evidence offered by CMS establishes a prima facie case
that Petitioner failed to provide care to Resident No. 23 that met
professional standards of quality. On its face, this evidence shows that
Petitioner was not attentive to a physician's orders concerning the
removal of the resident's catheter. The evidence establishes also that at
least the potential for harm existed in Petitioner's omission. Nursing
notes on May 8, 1999 stated that Resident No. 23 was pulling at the
catheter thereby suggesting that the catheter was causing the resident to
experience discomfort. HCFA Ex. 8 at 3 - 4. Petitioner asserts that the resident's physician did not
order that the catheter be removed after three to four days. Petitioner's
Post-Hearing Brief at 39 - 40. According to Petitioner, the physician only
said that the catheter may be removed after three or four days
and left it to Petitioner's staff's discretion to decide when to do so.
Petitioner supports this assertion with the testimony of Michael Foster,
M.D., who served as Petitioner's medical director. P. Ex. 3 at 2556 -
2560. Dr. Foster testified that the physician's order was written in a way
that permitted the Foley catheter to be removed in three to four days, but
which did not require that it be removed within three to four days.
Id. at 2822. He testified that removal of the catheter by
Petitioner's staff was not a decision that required his
consultation. I am not persuaded by this evidence. I do not question Dr. Foster's testimony that he gave Petitioner's staff discretion to decide on the precise timing for removal of the resident's Foley catheter. Nor do I find that removal of the catheter after the elapse of more than four days necessarily would have been inappropriate had the resident's condition warranted a delayed removal of the catheter. But, the evidence offered by CMS shows that the delayed removal of the resident's catheter was a consequence of an omission by Petitioner's staff to assess the resident's condition and to decide the most appropriate timing for removal. There was no exercise of judgment or discretion in this instance to delay removal of the catheter. Rather, the removal was delayed because the staff forgot to remove it. That is not care which meets professional standards of quality.
CMS offered evidence that shows that Resident No. 5
suffered from both diabetes and an infection. HCFA Ex. 8 at 4 - 6. It
asserted that there was a pattern of failures by Petitioner's staff to
notify the resident's treating physician of potentially significant
changes in the resident's medical condition. The resident's medical record contained a directive
requiring Petitioner's staff to notify the resident's treating physician
whenever the resident's blood glucose levels exceeded 400. But, the
resident's blood glucose levels equaled or exceeded 400 on several
instances in April 1999 and the resident's physician was not called.
Id. at 4. The resident's medical record also showed that on April
24, 1999 a physician's assistant had ordered a change in the amount of
antibiotics to be given to the resident. However, there was a delay in
receiving the antibiotic from the pharmacy resulting in a delay of about
31 hours in administering the antibiotic to the resident. The resident's
physician was not notified of this delay. Id. at 5. Finally, the
resident's medical record showed that, on May 1, 1999, the resident had
experienced an elevated temperature. An unsuccessful attempt was made to
notify the resident's physician. No follow up calls were made to the
physician until the next day although the physician failed to respond to
the initial notification that the resident had an elevated temperature.
Id. at 5 - 6. The evidence offered by CMS is prima facie evidence of a
pattern of failures by Petitioner's staff to notify Resident No. 5's
treating physician of potentially significant changes to the resident's
medical condition. This evidence shows that there were several instances
in which the resident manifested elevated blood glucose levels, but
Petitioner's staff failed to follow a directive in the resident's records
to notify the physician of that change. The evidence also shows that
Petitioner failed to notify the resident's physician of a 31- hour delay
in administering antibiotics to the resident and failed to act diligently
to assure that the physician was aware of an episode in which the resident
experienced an elevated temperature. Petitioner did not rebut the prima facie case of
noncompliance. First, Petitioner argues that there was no order signed by
a physician that the resident's physician be notified of episodes in which
Resident 5's blood glucose level exceeded a count of 400. Petitioner's
Post-Hearing Brief at 40. But, whether or not this is true is irrelevant
to deciding whether Petitioner's staff failed to comply with professional
standards of quality of care in providing care to Resident No. 5. The
resident's medical record contained a written directive that the physician
be notified if the resident's blood glucose level exceeded 400. M0927. The
reasonable inference that anyone on Petitioner's staff would have drawn
from this instruction is that the physician wanted to be notified of
elevated blood glucose levels. Given that, failure to abide by the
directive constituted a dereliction of duty to the resident. Second, Petitioner asserts that the delay in administering antibiotics to Resident No. 5 had a "negligible" effect on the resident. From this, Petitioner contends that there was no potential for more than minimal harm in failing to administer antibiotics timely to the resident. Petitioner relies on the testimony of its medical director, Dr. Michael Foster, as support for this contention. P. Ex. 3 at 2827 - 2828. This argument is not persuasive. The thrust of Dr. Foster's testimony is that a missed dose of antibiotics would not be significant in view of the fact that the course of antibiotics that was prescribed for Resident No. 5 was to be administered over a period of 14 days. Id. Arguably, that might be so for a short delay. However, he failed to explain how a delay of 31 hours in administering antibiotics to this resident would be insignificant. See Id. Moreover, CMS offered the testimony of its own expert physician, Dr. Melvin Oskvig, who presented a contrary view. HCFA Ex. 19 at 3338 - 3339. Dr. Foster's opinion does not overcome Dr. Oskvig's opinion by a preponderance of the evidence.
The evidence offered by CMS which relates to Resident No.
28 establishes that this resident sustained an injury to her ankle as a
consequence of a fall that occurred on May 2, 1999. HCFA Ex. 8 at 6. The
resident's physician ordered that the resident's ankle be x-rayed, that
ice be administered to the resident's ankle for a period of 24 hours, and
that the resident not bear weight on the ankle for 24 hours. Id. An
x-ray was taken which did not establish a fracture. On May 12, 1999, the
resident was observed to be ambulating and complaining of pain. Id.
at 7. The resident's records did not reveal that there had been a
follow-up evaluation of the resident's injury, nor did they show that the
resident's physician had been notified of the resident's continuing
complaints of pain. This evidence establishes a prima facie case of a failure
by Petitioner's staff to provide care that met professional standards of
quality. The resident had injured her ankle and was continuing to complain
of pain 10 days later. Yet Petitioner's staff had not evaluated the
resident's continuing complaints, nor had they discussed them with the
resident's treating physician. I do not find that Petitioner rebutted this prima facie
evidence of noncompliance. Petitioner argues, essentially, that the
resident's course of recuperation from her ankle injury was normal and
expected for an injury of that type. Petitioner's Post-Hearing Brief at
43. It asserts that pain and swelling in the resident's ankle were not
unexpected consequences of the injury. Consequently,
according to Petitioner, it was not necessary or required that the
resident be seen by her treating physician. Id. However, this argument begs the question of what Petitioner's staff was obligated to do for the resident. The dereliction in duty to Resident No. 28 does not involve the care provided by the physician, but the care that was provided by Petitioner's staff. It may very well have been true that the resident's treating physician would have declined to modify or alter the resident's prescribed care had he been notified of the resident's continuing complaints of pain. But, the important point here is that, by failing to evaluate or assess the resident's complaints, Petitioner's staff deprived the physician of information that he should have received.
CMS offered evidence to establish that Petitioner's staff
inserted a rectal tube into Resident No. 9 without a physician's order in
an effort to relieve the resident's signs of abdominal distension and
complaints of dyspepsia. HCFA Ex. 8 at 7 - 8. And, it offered evidence to
show that inserting a rectal tube without a physician's order exceeds the
permissible scope of nursing practice. HCFA Ex. 12 at 91; HCFA Ex. 13 at
341; HCFA Ex. 19 at 3413. This evidence establishes a prima facie case of
Petitioner's failure to provide care that met professional standards of
quality. If not rebutted, the evidence offered by CMS establishes that
Petitioner's staff contravened widely accepted standards of nursing
practice when it inserted a rectal tube without a physician's order to do
so. Petitioner's attempted rebuttal is not persuasive. First,
Petitioner argues that the rectal tube was a reasonable treatment for the
resident's complaints and signs. Petitioner's Post-Hearing Brief at 44.
However, whether or not a physician might ultimately have ordered the
insertion of a rectal tube for Resident No. 9 is not being questioned
here. The question is whether Petitioner's staff exceeded the bounds of
that which nursing standards permitted it to do. That question is not
answered by evidence showing that, in retrospect, what the staff did would
have been authorized had a physician known about it. Second, Petitioner contends that its staff had been advised by the New York State Department of Education that a physician's order for insertion of a rectal tube is not required if a facility has a policy allowing nurses to insert a rectal tube without a prior order by a physician. Petitioner's Post-Hearing Brief at 44; P. Ex. 2 at 2642 - 2643. I find this contention not to be persuasive. It rests entirely on the hearsay testimony of a member of Petitioner's staff. Petitioner offered no corroboration that the New York State Department of Education actually has a policy permitting nurses to insert rectal tubes without a physician's prior order, nor did Petitioner offer corroboration that such information actually was communicated to Petitioner's staff. Moreover, Dr. Milene A. Sower, Executive Secretary for the Board for Nursing and Respiratory Therapy, New York State Department of Education, testified that a "standing order" by a facility allowing its staff to insert a rectal tube without a prior physician's order is not permitted by New York State policy. HCFA Ex. 13 at 348.
CMS offered evidence to establish that, on May 8, May 9,
and May 10, 1999, Resident No. 8 was observed to be receiving oxygen. HCFA
Ex. 8 at 8. It offered evidence to show that there was no statement in the
resident's record which explained why the resident was receiving oxygen.
Moreover, although Petitioner's policy required notification of a
physician or a physician's assistant within 24 hours of administration of
oxygen to a resident, there was no evidence in the resident's record that
such notification had been provided. Id. CMS offered evidence to
establish that no order was written by a physician's assistant directing
that the resident receive oxygen until May 10, 1999. Id. CMS also
offered evidence to show that professionally accepted standards of care
permit a facility's staff to begin administering oxygen in an emergency
without prior approval by a physician, but that the staff must then
consult with a physician for further direction. HCFA Ex. 13 at 343 - 344.
Petitioner's own internal policy is consistent with this standard of care.
HCFA Ex. 8 at 8 - 9. The aforesaid evidence, if unrebutted, establishes a prima
facie case that Petitioner failed to provide care to Resident No. 8 that
met professional standards of quality. The evidence shows that
Petitioner's staff administered oxygen to Resident No. 8 for a period of
three days without receiving prior authorization from a physician or
physician's assistant and without notifying the physician or physician's
assistant of the action. The prima facie evidence is that such action by
Petitioner's staff contravenes professionally accepted standards of
quality and Petitioner's own internal policies. Petitioner's principal defense to these allegations is to
argue that the resident had a medical condition which required
administration of oxygen, that the resident had been administered oxygen
previous to her admission to Petitioner's facility, while hospitalized,
and that it was a "clerical oversight" that the hospital's records failed
to contain an order for continued administration of oxygen to the
resident. Petitioner's Post-Hearing Brief at 45. From this, Petitioner
contends that administration of oxygen to Resident No. 8 was part of the
normal therapy for the resident and that its staff committed no error in
failing to receive authorization from a physician or physician's assistant
before implementing oxygen therapy. This argument does not address CMS's central contention concerning the care that Petitioner's staff gave to Resident No. 8. The issue here is not whether administration of oxygen to Resident No. 8 was appropriate, but whether Petitioner's staff failed to engage in requisite consultations with a physician or a physician's assistant after it began to administer oxygen. Petitioner failed to prove that it's staff was not required to engage in consultations. And, Petitioner did not prove that the mandatory consultations were made. The fact that an order to administer oxygen might have
been omitted from Resident No. 8's record of a prior hospitalization was
not a license to Petitioner's staff to administer oxygen without
consulting a physician. To the contrary, if staff was aware that the
resident had been administered oxygen while in the hospital, but failed to
receive an order to continue to administer oxygen, staff should have
consulted with the resident's physician or a physician's assistant. But,
staff did not do so. The potential for harm in Petitioner's staff's failure to consult with a physician or a physician's assistant about the administration of oxygen to Resident No. 8 is evident, not only from Petitioner's failure to comply with the professionally accepted standards of quality for administration of oxygen, but by its failure to comply with its own internal policy. Good nursing practice required consultation after administration of oxygen and Petitioner's staff failed to consult.
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JUDGE | |
Steven T. Kessel Administrative Law Judge | |