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Department of Health and Human Services DEPARTMENTAL APPEALS BOARD Civil Remedies Division |
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DATE: January 28, 2002 |
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Centers for Medicare & Medicaid
Services
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Docket No.C-99-271
Decision No. CR862 |
| DECISION | |
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DECISION I sustain 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,
Meadow Wood Nursing Home ("Petitioner," or "Meadow Wood," or "facility"),
for its failure to comply substantially with federal requirements governing
participation of long-term care facilities in Medicare and State Medicaid
programs. These remedies included: a civil money penalty (CMP) at the
immediate jeopardy level of $3,050 per day for 10 days from July 23, 1998
through August 1, 1998; and a CMP of $50 per day, for 132 days from July
23, 1998 through December 1, 1998. I. Background This case came before me pursuant to a request for hearing
filed by Petitioner on November 5, 1998, in accordance with section 1128A(c)(2)
of the Social Security Act ("Act") and 42 C.F.R. §§ 488.408(g), 498.40. The request for hearing stems from a standard survey conducted by the Ohio Department of Health (ODH) on August 11, 1998. During the survey, ODH surveyors identified deficiencies including a pattern of deficiencies that the surveyors alleged constituted immediate jeopardy. ODH recommended several remedies which CMS concurred with. On September 9, 1998, CMS imposed the following remedies:
At a follow-up survey, conducted October 8, 1998, ODH
determined that two deficiencies persisted at the "D" scope and severity
level. After Petitioner filed its request for a hearing on November 5,
1998, another follow-up survey was conducted on November 10, 1998. During
that survey, ODH discovered one deficiency at the "D" level. Substantial
compliance was verified during a third follow-up survey conducted on December
11, 1998. In my Ruling dated June 18, 2000, I granted CMS' Motion
for Partial Summary Affirmance and affirmed the DPNA from September 29,
1998 through December 1, 1998. I also affirmed the $50 per day CMP for
the entire period from July 23, 1998 through December 1, 1998. Additionally,
I ruled that Petitioner had adequately preserved only its challenge to
deficiencies cited in the August 1998 survey. I further ruled that Petitioner's
challenge to 13 "F-tags"(1) cited during
the follow-up surveys of October and November 1998 were not preserved.
I ruled that Petitioner preserved challenges to the deficiencies cited
by CMS as F-323(K), F-312(G), F-314(G), F-316(G), F-324(G), F-498 (D),
F-371(F), and F-318(D). I indicated in my ruling that if Petitioner established
substantial compliance with those F-tags at hearing, with the exception
of F-323 which was cited at the immediate jeopardy level, the $50 per
day CMP and the DPNA would not be affected, other than possibly the CMP
being increased if I decided the evidence at hearing warranted an increase.
Nonetheless, despite the absence of the opportunity for Petitioner to
advantageously affect the CMP, the issues were adequately preserved. Therefore,
I ruled that Petitioner was entitled to a hearing on them in accordance
with 42 C.F.R. § 498.40(b). I presided at a hearing of this case in Cincinnati, Ohio,
from June 26 through June 28, 2000. CMS was represented by Ms. Shirley
Moscow Michaelson and Petitioner was represented by Mr. Geoffrey E. Webster. At hearing, Petitioner offered five exhibits which were
admitted into evidence without objection from CMS as Petitioner's Exhibits
1-5 (P. Exs. 1-5 ). CMS offered 41 exhibits into evidence and Petitioner
objected to several of them. In addition, CMS withdrew three exhibits,
and I reserved ruling on the admission of two other exhibits until after
the hearing. Accordingly, the following CMS Exhibits(2)
are admitted, including all of the exhibits Petitioner objected to which
I admit over its objection: HCFA Exhibits 1-27, (HCFA Exs. 1-27) (HCFA
Exhibits 28-30 were withdrawn) HCFA Exhibits 31-32, (HCFA Exs. 31-32)
(the two exhibits I reserved ruling on the admissibility of until after
the hearing) which were admitted by ruling dated August 24, 2000, and
HCFA Exhibits 33-41 (HCFA Exs. 33-41). Finally, at the close of the hearing
I admitted into evidence a Polaroid photograph, offered by Petitioner,
which I designated ALJ Exhibit 1 (ALJ Ex. 1). II. Applicable Law and Regulations Petitioner is considered a long-term care facility under
the Act and the regulations promulgated by the U.S. 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. 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, 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, 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). The terms "substantial compliance" and "immediate jeopardy" are defined terms in the regulations. "Substantial compliance" is defined as:
"Immediate jeopardy" is defined as:
In determining the amount of the CMP, the following factors specified at 42 C.F.R. § 488.438(f) must be considered:
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's showing by a preponderance of the evidence. Hillman Rehabilitation
Center, DAB No. 1611 (1997). 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. 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 issues in this case are whether:
IV. Findings and Discussion My conclusions of law and findings of fact (cited in italics), below, are followed by my analysis and discussion.
CMS cited the facility at the immediate jeopardy level
for allowing several unsafe bed rails to be used on some of the residents'
beds. CMS alleged that the condition of some of the rails, observed by
the surveyors to be loose, wobbly, and in some instances having gaps between
the mattresses and rails, constituted accident hazards. CMS focused its
allegations on two residents, R2 and R3, who were injured in incidents
involving their bed rails. But CMS also alleged that the hazardous conditions
were widespread in the facility, citing as examples 12 other beds the
surveyors inspected and found unsafe. As I discuss in detail below, I find that the facility
allowed accident hazards which could have been easily remedied to persist
at great risk to the residents. In fact one resident, R2, suffered actual
harm, which easily could have been much worse, as a direct result of the
facility's failure to ensure his bed rails were working properly. The
additional instances of unsafe bed rails cited by CMS, including those
on R3's bed and on 12 other beds, also show the facility failed to ensure
that the bed rails were safe. Therefore, based on the facts, most of which do not seem
to be disputed, I find that CMS carried its burden to present a prima
facie case. Petitioner failed to effectively rebut CMS's case with its
own showing that it substantially complied with the regulation. Underlying
this conclusion is my consideration of the evidence, arguments of the
parties, and my findings of fact, construed in light of the regulation. The relevant regulation is 42 C.F.R. § 483.25(h)(1), which provides in pertinent part:
I find the following facts concerning R2 and R3's bed
rails, and the condition of several of the other bed rails in the facility.
First, the relevant facts concerning R2 are that he was 100 years old,
partially paralyzed, and dependant on staff. He was assessed by the facility
as requiring assistance with toileting, including putting a urinal he
used in bed in position for use. Tr. at 111-114, 118-119, 375-76; HCFA
Ex. 21 at 3, 10, 12-13. R2 had balance problems, and he used the bed rails
to turn and reposition himself. Tr. at 375-76; HCFA Ex. 21 at 2. At 7:00
p.m. on July 22, 1998 it was discovered that R2's side rail had fallen
and a nurse aide noted that the rail fell easily. A chair was used to
prop it up and maintenance was notified. HCFA Ex. 21 at 13. R2 was given
a sleeping pill that night. Then, at approximately 1:40 a.m on July 23,
1998, R2 called for help. HCFA Ex. 21 at 14. R2 had leaned on his bed
rail and it had collapsed. HCFA Ex. 21 at 15. R2 fell to the floor and
was injured. He suffered skin tears, scrapes, and bruises. Tr. at 70;
HCFA Ex. 21 at 14. R2 was put back in the same bed while a temporary fix
was attempted with the side rail. Tr. at 841; HCFA Ex. 21 at 15. On July
29, 1998, R2 complained that his bed rails would fall down. HCFA Ex. 19
at 5. His rails were observed to have loose nuts and bolts and the rails
rocked back and forth. HCFA Ex. 19 at 5. While these observations were
occurring, R2's rail fell; it was the same rail that fell on July 23,
resulting in his injuries. Tr. at 66, 68, 376; HCFA Ex. 21 at 9. There
was no chair or other temporary fix in place at the time R2's rail fell.
Tr. at 66, 377. Next, I find the relevant facts concerning R3. R3 was
a newly admitted resident from another facility. He had dementia, delusions,
depression, and Alzheimer's. In addition, R3 was combative and resistant
to care. Tr. at 692, 733. R3's physician had ordered side rails for R3's
safety. Tr. at 691. R3 was a physically strong man, and he would shake
his bed rails violently. Tr. at 733-735; 820. At approximately 4:00 p.m.
on July 28, 1998 R3's rails were observed with loose screws and a loose
bracket. Tr. at 50-52; HCFA Ex. 22 at 7. At 10:30 p.m. that night R3 was
shaking the side rail and it fell down causing R3 to fall out of bed.
He suffered minor injuries to his right knee and left toe in the fall.
HCFA Ex. 22 at 11. Then, at 11:15 p.m., R3 shook his side-rail again.
This time the metal bracket where the bed-rail connected to the bed frame
snapped, and R3 again fell to the floor. Tr. at 54-55, 842; HCFA Ex. 22
at 4. In this second fall R3 suffered bruises, abrasions and hematomas
to his body, face and head. Tr. at 53; HCFA Ex. 22 at 5. On July 29, 1998,
R3 was observed in a different bed. The new bed had 3/4 length side rails.
Staff observed R3 hanging off the lower portion of the bed beyond the
length of the side rails. Tr. at 59; HCFA Ex. 22 at 4. The new bed was
also observed to have a 3-4 inch gap between the rail and mattress. Tr.
at 59-62; HCFA Ex. 22 at 5. Finally, concerning the other instances of unsafe rails
alleged by CMS, I find the relevant facts are that on July 30 and 31,
1998, 12 other beds were observed to have loose or wobbly rails, and some
of them had gaps between the rails and mattresses. Tr. at 77-78, 374-75;
HCFA Ex. 19 at 5. On August 1, 1998, the facility's maintenance man provided
the surveyors with a list of bed-rails that had been checked, and the
list noted whether any maintenance was performed. Tr. at 94-95, 108; HCFA
Ex. 19. The surveyors determined that immediate jeopardy was abated after
reviewing the list. Tr. at 94-95, 108. Considering the instance of R2's rails first, I conclude
that Petitioner did not substantially comply with its duty to protect
this resident from accident hazards to the extent possible. Petitioner
made no convincing challenge to CMS's prima facie case that R2 faced an
accident hazard the facility knew about and could easily have fixed. The
evidence shows me that R2 was a 100-year-old man, who had documented problems
with his balance. Furthermore, the facility knew he leaned on his bed
rail to reposition himself and to use his urinal, but staff gave him a
sleeping pill and knowingly left him in a bed with a perilously loose
bed rail. To make matters worse, the facility failed to take steps to
fix the problem. R2 remained in the same bed with the loose rail even
after he fell, and despite numerous incidents of the rail falling spontaneously
and easily. This was an avoidable accident hazard. Moreover, I find the
testimony of Mr. Crout, to the effect that the rail was not broken, but
that in their haste the staff was not pulling the rail into its locked
position, an affirmation of noncompliance with the regulation. Tr. at
839-40. Petitioner has offered no evidence or argument that refutes the
facts supporting my conclusion regarding R2's bed rails. The facts applied to the instance of R3's bed rails leads
me to conclude that R3 was faced with an avoidable accident hazard, albeit
not for the reason that CMS made the main thrust of its argument. CMS
introduced evidence that R3 shook his rail until it collapsed in one instance,
and shook his rail until he broke the rail off in another, both incidents
resulted in R3's falling and injuring himself. CMS also introduced evidence
that the bed R3 fell from had loose screws and a loose bracket. And CMS
introduced evidence that the bed R3 was ultimately
moved to had 3/4 length side rails instead of full length side rails,
and a 3-4 inch gap which CMS concluded created a risk of entrapment. CMS's
brief at 12. CMS's emphasis seems to be that play in the rail - the
fact that it moved back and forth, led to the rail snapping when R3 shook
it. And CMS suggests that the loose screws and bracket allowed the play
in the rail, which, in turn, allowed the rail to snap. I agree with Petitioner
to the extent that it argued the shearing of the metal holding the rail
in place does not show there was an accident hazard. Petitioner's brief
at 17. I note that, when R3 fell the first time there is evidence that
he shook the rail violently until it collapsed. It seems dubious to fault
the condition of the bed rail without evidence showing a correlation,
although it might suggest there was a failing under a different F-tag
not at issue. Nonetheless, without more specific evidence, I do not conclude
that R3 faced an accident hazard the facility was responsible for by virtue
of his shaking the rail until it gave way. Nor do I find it convincing
that a surveyor observed R3's new bed had side rails that were too short.
Three quarter length rails are not a hazard in and of themselves. That
is a determination that must be resident or patient specific. And while
the evidence here is suggestive that full length rails might have been
better suited to R3, CMS has left the evidence on this point undeveloped,
and, therefore, insufficient to support a deficiency. The gap between
the mattress and rails, however, concerns me. CMS argues that the 3-4 inch gap in R3's new bed created
a risk of entrapment in the side rail. CMS's brief at 22-28. The hazards
associated with bed rail entrapment, coupled with the documented mental
impairments of R3, constitute a prima facie showing that the gap did present
an accident hazard to the resident. This contention is not refuted by
Petitioner. Accordingly, I find that the record establishes that R3 was
not safeguarded from accident hazards to the extent possible, as required
by the regulation. Finally, the facts applied to the other 12 beds lead me
to conclude that there were many other instances of residents being exposed
to preventable accident hazards because of the condition of the facility's
bed-rails. CMS found 12 instances of loose or wobbly rails or gaps between
the rails and mattresses. CMS's brief at 16; Tr. 77-78, 374-375; HCFA
Ex. 19 at 5. And there is substantial evidence in the record that there
were indeed bolts that needed to be tightened, and rails that needed to
be repaired or replaced. HCFA Ex. 19. Yet a review of Petitioner's brief
shows that this evidence is uncontroverted. Petitioner's brief at 16-19.
Petitioner does argue that "after all, the side-rails necessarily had
some "play" in them because they were not actually a part of the bedframe
itself but attached to it." Petitioner's reply brief at 3. However, "some
play" is different from "loose" which is the fact I have found based on
the observations of the surveyor and the evidence showing that repairs
were necessary on many of the bed rails, and the lack of evidence to the
contrary, i.e. that the "play" was normal in the instances cited by the
surveyors. Furthermore, Petitioner does not address the gaps between the
rails and mattresses on the 12 other beds. Thus, there is a prima facie
showing that there were many instances of bed-rails in hazardous condition
and no evidence in rebuttal. I conclude that Petitioner was not substantially complying with 42 C.F.R § 483.25(h)(1) from the time that R2 fell out of his bed on July 23, 1998, until the surveyors were presented with a list of beds that had been checked, and, where necessary, fixed, on August 1, 1998.
I find that Petitioner failed to provide adequate grooming
and hygiene to residents 3, 15, and 9 (R3, R15, and R9) as required by
the regulation. This failure resulted in actual harm to R3, and put R15
and R9 at risk for more than minimal harm. The allegations regarding these
three residents are essentially that the facility failed to properly clean
the residents as part of their incontinence care, failed to bathe the
residents as part of their regularly scheduled grooming and hygienic care,
and, in the case of R9, failed to clean debris that accumulated around
the resident's feeding tube. 42 C.F.R. § 483.25(a)(3) requires that the facility, based
on the comprehensive assessment of the residents, ensure that "a resident
who is unable to carry out activities of daily living receives the necessary
services to maintain good nutrition, grooming, and personal and oral hygiene." I find the following facts concerning this F-tag and R3. In addition to the requirement that residents receive necessary nutrition, grooming, and hygiene, the interdisciplinary plan of care for skin integrity developed for R3 required that he receive prompt pericare after each incontinent episode. Tr. at 156; HCFA Ex. 22 at 16.
On July 28, 1998 from 12:20 p.m. until 4:00 p.m., R3 was
observed in a chair in his room and no incontinence care was provided
during that period. R3 stank of urine, was dressed in only a hospital
gown, and had a heavy growth of beard. The staff told the surveyor, Ms.
Truett, that R3 was scheduled for a shower on July 28. And the staff explained
that R3 had not been dressed because he was due for that shower. Tr. at
151-152. R3 was in discomfort because no pericare had been provided. He
was observed "scooting his buttocks on the chair, trying to raise up out
of the chair." Tr. at 152. At about 4:00 p.m., the staff provided incontinence
care to R3. By that time R3's coccyx and buttocks were red and "excoriated."
R3 was not bathed as scheduled on July 28 and 29. He was finally bathed
on July 30, 1998. I conclude from these facts that CMS's evidence is sufficient
to establish a prima facie case that the facility did not provide the
services required by 42 C.F.R. § 483.25(a)(3). Petitioner denies that R3 was not bathed as scheduled
and makes two arguments to support the denial, neither of which I find
persuasive. Petitioner's arguments are essentially that, first, R3 was
bathed (Petitioner's reply brief at 10), by which I assume it means bathed
as scheduled or bathed on July 28 and 29, 1998. Second, Petitioner alleges
that the surveyor, Ms. Truett, could not have observed the alleged lack
of prompt pericare because there is no contemporaneous notation in the
surveyor notes of the sore Ms. Truett claims to have observed on R3's
coccyx. Petitioner's reply brief at 10-11. To support the assertion that R3 was bathed Petitioner
points to several cites in the record. Petitioner's reply brief at 10-11.
I have examined the references, and determined that they do not support
the propositions for which Petitioner cites them. For instance, Petitioner
relies on the testimony of Ms. Ninichuck, an employee working in social
services who had formerly worked in the rehabilitation area of the facility.
In an exchange apparently intended to show that R3 was receiving range
of motion exercises Ms. Ninichuck stated: "[h]e was getting range of motion
with bath everyday. A formal program had not been written up. We had not
met with the interdisciplinary team at this time to write a formal program."
Tr. at 561. This contrasts with Ms. Truett's testimony that she observed
R3 unbathed on July 28 and 29. Although Petitioner attempts to dismiss
CMS's evidence as "pure hearsay" (Petitioner's reply brief at 10), I am
persuaded that this contrast shows the weakness in relying on Ms. Ninichuck's
testimony to conclude that R3 was bathed on the two specific days. Ms.
Ninichuck was stating in general terms what the informal program was for
range of motion services. In the process she inadvertently included what
the facility's bathing schedule was supposed to be. This is a far cry
from an affirmative statement that R3 was in fact bathed on July 28 and
29. Petitioner also cites HCFA Ex. 18 at 10 to compare with
Ms. Ninichuck's testimony described above. Petitioner's reply brief at
10. It is not clear why Petitioner refers to this exhibit. Petitioner
does not indicate in what way HCFA Ex. 18 supports the assertion that
R3 was bathed; and it is not evident by reviewing the exhibit (a surveyor
notes worksheet) what Petitioner intended. Petitioner also cites testimony from Ms. Jefferson, who
explained the facility's bathing schedule. Petitioner's reply brief at
10. Petitioner argues that Ms. Jefferson's testimony shows that there
is implicit evidence that R3 was bathed on July 28 and 29. However, the
testimony Petitioner cited (Tr. at 702) indicates that there is not a
daily bathing record for R3, nor any notations concerning R3 in the daily
bathing records. None of the evidence in the record gives any support
to Petitioner's contention that R3 was bathed on July 28 and 29. Thus, Ms. Truett's testimony that R3 was not bathed on
July 28 or 29, despite staff assurances that he was scheduled to be bathed,
is not refuted by any evidence. I find Ms. Truett's testimony to be credible
and compelling. As I indicated above, Petitioner's final contention concerning
R3 and this F-tag is that Ms. Truett's observations are suspect partly
because, Petitioner suggests, in a recurring, but unsubstantiated and
unconvincing theory, her recounting of how she made her observations places
her in too many locations at once, and that her observations are suspect
partly because there is no contemporaneous mention of a sore on R3's coccyx.
I am not persuaded that Ms. Truett's pattern of making observations shows
the observations themselves are unreliable because they place her in too
many locations at once. I am not persuaded because there is no reason
to suspect this. Petitioner has raised the specter of fraud, or unreliable
observations and testimony, apparently based solely on the fact that Ms.
Truett made more than one observation relatively close in time as the
survey progressed. As for the second part of Petitioner's contention concerning
this surveyor's observations and R3, I note that HCFA Ex. 22 at 6, Ms.
Truett's surveyor notes worksheet for 7/28/98-8/1/98, shows a diagram
indicating red excoriation and red buttocks. I conclude that the evidence in the record does not support
Petitioner's contention that R3 was bathed as scheduled, nor that I should
find Ms Truett's testimony not credible. Petitioner has not carried its
burden to show that it is more likely than not that it substantially complied
with 42 C.F.R. § 483.25(a)(3) in its care of R3. Turning now to R15, I find the following facts. The interdisciplinary
plan developed by the facility for R15 had a skin integrity plan that
included several measures for R15's well being. Tr. at 140. The measures
included turning and repositioning, moving the resident to a chair when
possible, the provision of heal protectors at all times while in bed,
pillow or sheepskin between R15's knees and legs, prompt pericare after
each incontinent episode, and that bed linen be kept clean and wrinkle
free Tr. at 140-141; HCFA Ex. 4E at 42-43. On July 30, 1998, Ms. Truett observed R15 receiving a
bed-bath and incontinence care. The bath was given by a nurse-aide using
washcloths, but without any clean water for rinsing the wash cloths or
R15. Ms. Truett observed soap residue on R15 which was not rinsed off.
Ms. Truett concluded that this manner of giving R15 a bath, and the soap
residue, put R15 at risk for skin breakdown. Tr. at 143. After the bed-bath,
R15 urinated, and the nurse did not reclean R15 before putting on R15's
incontinent brief. Tr. at 143. The nurse aide acknowledged that R15 needed
to be cleaned again, however, no further cleaning or care was given to
R15. Tr. at 144; HCFA Ex. 18 at 10. Staff indicated that R15 was scheduled to be given a shower
on July 28, 1998. Tr. at 149. Then, on July 29, staff told Ms. Truett
that residents were not being given showers. The washcloth bath described
above was given on July 30. Tr. at 149. Ms. Truett concluded that R15
was not given appropriate hygiene care because R15 was incontinent, suffered
from skin breakdown, and was at risk for further skin breakdown and other
complications, and, therefore, required thorough cleansing. Tr. at 150;
HCFA Ex. 27 at 6. Petitioner's argument appears to be that Ms. Truett was
either distracted or unable to make the observations concerning R15's
hygienic care, including the details of the resident's wash cloth bath
and the soap residue left on R15's skin. Petitioner also seems to indicate
that Petitioner was unable to adequately present its case regarding R15
and the allegations concerning hygienic and grooming care because the
staff member or staff members who Ms. Truett observed were not identified
by name. Petitioner's reply brief at 9. While Petitioner's arguments are difficult to decipher,
and I do not wish to speculate what they mean, I will point out that insinuation
unsupported by evidence is not sufficient to rebut a prima facie case
by a preponderance of the evidence. Insofar as it addresses CMS's allegations
of noncompliance regarding the hygienic and grooming care of R15, Petitioner's
reply brief reads more like commentary than argument where Petitioner
writes:
Petitioner's reply brief at 9. This paragraph appears
to be the entirety of what Petitioner wishes me to consider regarding
the alleged deficiency of the hygienic and grooming care afforded R15.
It states the issue is whether R15 was put as risk for more than minimal
harm, but then doesn't address that point further. It suggests that Ms.
Truett made multiple observations at approximately the same time, but
didn't note the observations well. It suggests that it was unfair of CMS
not to identify by name what staff person Ms. Truett spoke with and observed
providing care to R15. It states that Ms. Truett's conclusions regarding
the wash cloth bed-bath given to R15 are fantastic. And it seems to suggest
that Ms. Truett's testimony based on hearsay should be discounted, although
Petitioner must know that hearsay is admissible in these proceedings.
I am at a loss to discern any argument in Petitioner's statement, other
than an obliquely made comment that CMS's determination is somehow unreliable
or unfair. Petitioner has introduced neither evidence to attack the reliability
of Ms. Truett's personal observations nor evidence that CMS was mistaken
in its conclusion that the hygienic and grooming care offered to R15 on
the dates in question was inadequate. Thus, even if I disregard statements
attributed to the unidentified staff member, Petitioner has not surmounted
its burden to show that it is more likely than not that Petitioner was
in substantial compliance with the regulation. The facts concerning this F-tag and R9 are as follows.
R9 was dependent on tube feeding for nutrition and hydration because he
did not eat or drink by mouth. He was dependent on the staff to clear
his mouth and secretions from his mouth. Tr. at 157. The care plan developed
for R9 required that he be given oral care every two hours and as needed.
Tr. at 157; HCFA Ex. 23 at 9. On July 28, 1998, R9 was observed from 12:40
p.m. until 4:10 p.m. Tr. at 158. Ms. Truett observed that there was a
"heavy accumulation of white, thick secretions, and mucus and crusty stuff
in and on his mouth." Tr. at 158. At 2:20 p.m., the staff was observed
providing R9 with incontinent care. However, although the accumulation
in and on his mouth was visible, the staff did not provide oral care.
Tr. at 158. When Ms. Truett concluded her observations at 4:10 p.m., no
oral care had been given to R9. Tr. at 158. Ms. Truett made notes from R9's nurse's notes. Tr. at
158-159. The clinical record indicated that at 4:30 a.m. on July 28, 1998,
the nurses had noted "restlessness, mouth full of foaming saliva and phlegm
cleaned by suctioning." Tr. at 159; HCFA Ex. 23 at 7. Ms. Truett observed
a nurse aide administering incontinence care at 2:20 p.m. on July 28.
During the care, the nurse aide dropped a wash cloth being used to clean
R9 on the floor. The washcloth was picked up and used on R9. Ms. Truett
concluded that using the dropped washcloth created the potential for contamination
and the spread of infections and bacteria from the floor to R9. Tr. at
159-160; HCFA Ex. 23 at 6. Ms. Truett also concluded, at the beginning of her observations
of R9's care, that the amount of buildup in R9's mouth was not consistent
with him having received oral care within the previous two hours. Tr.
at 338. CMS concluded that these facts show a failure to provide personal
and oral hygiene services to R9. This failure, CMS argues, created the
potential for more than minimal harm to him. CMS's brief at 44. Petitioner counters that R9 drooled constantly and implies
that, because R9 drooled constantly, he could not have accumulated the
white, crusty debris in his mouth. Petitioner also argues that it "defies
rational belief" that facility staff would continue to wash R9 with a
washcloth that had dropped to the floor in front of Ms. Truett. Petitioner's
brief at 7-8. Petitioner also raises again, as it did when discussing
R15, that it is "powerless to refute observations claimed by Truett, who
states that some risk was posed to [R9] when an (unknown) staff member
cleaned this resident with a washcloth that had been dropped on the floor."
Petitioner's reply brief at 9-10. While this contention by Petitioner
regarding R15 and R9 does not amount to an argument of its case, Petitioner
raises it several times. Petitioner apparently considers itself blind-sided
because, presumably, it was somehow prevented from developing evidence
because specific staff were not identified. I am compelled to note that
these statements Ms. Truett testified to, which Petitioner suggests are
unfair, were made by Meadow Wood's own employees. And the incidents as
alleged are sufficiently and clearly documented in the record. Therefore,
it does not seem insurmountable for Petitioner, which had advance notice
of what the allegations in this case are, to have found out which employees
were responsible for providing care to the residents at the dates and
times in question, and to have interviewed them to discover whether there
was evidence useful to Petitioner's case. Petitioner has not indicated
in its comments why it was unable to do that. Nor has Petitioner's cross
examination of Ms. Truett diminished the credibility of her observations.
Petitioner's argument against the substance of CMS's allegation
is that, because R9 drooled constantly, it was not possible for the white
crusty substance to build up in his mouth. Petitioner's brief at 7. To
make this point Petitioner relies on the testimony of Mr. Kraut, the director
of the facility, who testified "that man drooled constantly, and there
was no way for him to have a buildup in his mouth . . . [n]ow, potentially,
if you woke him up and he may not have drooled real--a whole lot, he may
have a little white on his lips . . . [b]ut it would never last." Tr.
at 746. And Petitioner cited the testimony of Ms. Jefferson who, when
asked, "[d]oes he have a good deal of spital? [sic]" responded, "He is
constantly slobbering." Tr. at 689. Finally, Petitioner also cites HCFA
Exhibit 23 at 7, the surveyor notes worksheet of Ms. Truett, which appears
to indicate that on July 28, she observed R9 with a mouth full of foaming
saliva. Presumably, although it is not entirely clear from the record,
Petitioner is suggesting that a mouth full of foaming saliva is inconsistent
with the white debris. Nonetheless, the notation on Ms. Truett's surveyor
notes worksheet seems consistent with her testimony. And I conclude that
Petitioner has not introduced evidence to meet its burden: substantial
compliance by a preponderance of the evidence. I conclude that, while a drooling individual might be
less prone to have certain kinds of buildup in is mouth because of the
flow of fluid, uncontrolled "drooling," "spittle," and "slobbering" may
in fact be conducive to the buildup of debris, because, when the individual
is unable to clean him or herself, the drool, spittle, and or slobber
may accumulate and cake, or form a crust. Common experience indicates
that a person with normal control of their bodily fluids, like saliva,
would be able to detect and preempt buildup. It seems likely that a person
who slobbers, and is not cleaned, would tend to be more prone to buildup
in and on his or her mouth than a person who does not drool. If anything,
the testimony of Mr. Kraut and Ms. Jefferson strengthens CMS's contention
that R9 had a build-up of white, crusty debris in and on his mouth. In
fact, neither Mr. Kraut nor Ms. Jefferson testified that they saw R9 during
the time in question and observed that there was no build up of debris.
Their testimony on the subject is limited to their opinions that R9 drooled
or slobbered too much for debris to build up. But Mr. Kraut conceded,
as noted above, that R9 might develop "white on his lips." Tr. at 746.
Petitioner introduced no other evidence that it complied with the requirement
to groom R9 and maintain his oral hygiene. The care plan called for oral care for R9 every two hours. And, in fact, Ms. Truett testified that the nursing notes she reviewed indicated that the facility was cleaning R9's mouth as provided for in the care plan, albeit not as frequently as required. Ms. Truett testified that the notes reflected oral care was provided early on the morning of July 28. This bolsters the allegation, and undermines Petitioner's assertion that R9 drooled too much to accumulate debris, because it indicates that R9's, drool, spittle, and slobber notwithstanding, accumulated something which required cleaning. Therefore, the nursing notes are consistent with the care plan requiring oral care every two hours. Petitioner has introduced nothing that would suggest that, when Ms. Truett made her observations, R9 had been given oral care as prescribed by the care plan. Consequently, I conclude that R9 was not provided the necessary services to maintain good grooming and oral hygiene, as required by 42 C.F.R. § 483.25(a)(3).
The parties agree that R15 was at high risk to develop
pressure sores because of several predisposing medical conditions. In
fact, R15 arrived at the facility with 13 or 14 pressure sores. Apparently,
those pressure sores were effectively treated at the facility. So the
issue is whether, after the dissipation of those pressure sores R15 had
upon admission, the facility failed to ensure that R15 didn't develop
any new sores, unless the new sores were clinically unavoidable. There is no dispute that R15 developed a new pressure
sore; therefore, the question is whether the development of the sore was
clinically unavoidable. I find that CMS has established a prima facie
case because it is undisputed that R15 developed a pressure sore while
under the facility's care; and I conclude that CMS's prima facie case
includes evidence that the pressure sore was not unavoidable. I also conclude
that Petitioner has not borne its burden of establishing that it was in
substantial compliance with the regulation. Petitioner needed, but was
unable, to prove that the pressure sore that developed was clinically
unavoidable. 42 C.F.R. § 483.25(c) requires that the facility ensure
that a resident who is admitted without pressure sores does not develop
them, unless the individual's clinical condition demonstrates that they
were unavoidable; and a resident having pressure sores receives necessary
treatment and services to promote healing, prevent infection and prevent
new sores from developing. The requirement to keep residents free from pressure sores
unless unavoidable is stringent. To establish its prima facie case that
a facility was deficient under this tag, CMS must merely show that a resident
developed a pressure sore after admission. The burden is on the facility
to show that the pressure sore was clinically unavoidable. Koester
Pavillion, DAB No. 1750, at 34 (2000). I find the following relevant facts. R15 arrived at the
facility frail and suffering from 13 or 14 pressure sores. Tr. at 646-48,
681-86. The sores were successfully treated and they healed. Tr. at 647.
After the sores healed, R15 was at risk to develop new pressure sores
because she had predisposing conditions including diabetes, poor circulation,
incontinence, Alzheimer's, and a predilection for infection. Tr. at 139-40,
649-52; HCFA Ex. 27 at 1, 3. R15 also suffered from contractures which
caused her legs to be permanently folded underneath her and to one side.
This resulted in her ankle, which developed the pressure sore, resting
sore-side down when she was in a seated position. Tr. at 138-39, 145.
To address R15's problem with pressure sores the facility developed an
interdisciplinary care plan. The plan called for utilizing an egg-crate
pad and water mattress on R15's bed, turning and repositioning her every
two hours, seating R15 in a chair daily to the extent she could tolerate
sitting up, providing R15 with heal protectors and sheepskin or a pillow
between her legs when she was in bed, providing R15 with prompt pericare
after each incontinent episode, and keeping her bed linen wrinkle free
and her skin clean and dry. Tr. at 140-41; HCFA Ex. 4E at 42. I find the following facts concerning the history of the
pressure sore for which the facility was found out of compliance with
the regulation. A stage one pressure ulcer was discovered on R15's foot
on April 2, 1998. By April 9, 1998, it had become worse. The pressure
ulcer was noted again on R15's right foot on June 17, 1998. By June 23,
1998, R15's physician had noted that the sore on her right foot was almost
healed. However, on June 27, 1998, R15's urine tested positive for the
bacteria provedentia stuarti. Then, on June 30, 1998, the same bacteria
was found in R15's sore. Tr. at 147, 328; HCFA Ex. 27 at 7. R15 was prescribed
Cipro twice a day, the wound was to be cleaned with soap and water, and
Gentamicin with a Tefla BID was to be applied. Tr. at 270. The Cipro was
prescribed for 21 days and discontinued on July 27, 1998. A new prescription
for Cipro was written on July 27 and discontinued on August 17, 1998.
Tr. at 269-70; HCFA Ex. 4E at 44-45. Despite the treatment, by July 21, 1998 the sore had worsened. The sore was identified as a stage IV pressure sore through the July 1998 survey. HCFA Ex. 27 at 7. During the survey, R15 was observed in bed linen that was wet with urine. Tr. at 141-42; HCFA Ex. 18 at 10; HCFA Ex. 27 at 6. On July 29, 1998, R15 was observed during incontinence care. Urine and feces were on her person, including her right foot which had the sore. Tr. at 141-42; HCFA Ex. 18 at 10; HCFA Ex. 27 at 6. The dressing on the sore was observed to be loose, and contaminated with urine and feces. Tr. at 142; HCFA Ex. 27 at 6. On July 23, 1998, a nurse was observed providing treatment to R15's sore. After removing the bandage, the nurse laid R15's foot with the sore on the dirty bed linens. Tr. at 142; HCFA Ex. 27 at 4. On July 30, 1998, R15 was observed seated in a chair in her room in accordance with her care plan; however, the foot with the sore was resting sore-side down on a foot rest with no pressure relief device. HCFA Ex. 27 at 8. CMS argues that despite the successful treatment of the
"13 or 14" pressure sores that R15 had upon arrival at the facility, the
facility allowed an avoidable pressure sore to develop. CMS alleges that
the sore was attributable to the facility's failure to observe the preventative
steps provided in the care plan the facility developed for R15. I conclude
that CMS established a prima facie case because it showed that a new pressure
sore developed while R15 was under the facility's care. I also conclude,
although I do not believe it was CMS's burden to do so, that CMS has offered
evidence which supports a finding that the pressure sore was not unavoidable.
The burden was on Petitioner to rebut CMS's evidence, or present an affirmative
case that the pressure sore was unavoidable. In an effort to meet its burden Petitioner appeared to
argue that the sore was unavoidable since some preventative care was given
to R15. While it is not disputed that some appropriate care was provided,
Petitioner attempts to characterize the care as good enough for me to
conclude the pressure sore was unavoidable. I disagree. Petitioner argues that the facility was treating the sore
"reasonably and effectively, and notwithstanding the presence of risk
factors that resulted in the manifestation of a clinically unavoidable
condition." Petitioner's brief at 9. In its brief Petitioner catalogued
the steps taken by the facility to treat R15's sore: R15 was prescribed
Cipro twice a day, the wound was washed with soap and water, and Gentamicin
with a Tefla BID was applied, Cipro was prescribed for 21 days, discontinued
on July 27, 1998, and, finally, a new prescription for Cipro was written
on July 27 and discontinued on August 17, 1998. Petitioner's brief at
9. Petitioner's approach seems to be that because the sore was being treated,
and the sore occurred anyway, the sore was clinically unavoidable. Petitioner's
characterization continues where it argues "[t]he treatment provided was
never proven to have resulted in infection or to have caused new sores
to develop." Petitioner's brief at 9. This points to an apparent misunderstanding
by Petitioner of its burden in this case. As I indicated above, CMS has
the initial burden merely to show that a sore developed while the resident
was under the facility's care. Under the undisputed facts in this case,
the burden then shifts to Petitioner to show that the sore was clinically
unavoidable. For Petitioner to argue that there was no proof that the
treatment resulted in infection or caused the new sore betrays its fundamental
misunderstanding. Moreover, as argued by CMS, a clinically unavoidable
sore is one that occurs when all that reasonably can be done to prevent
the sore is done. CMS's brief at 43. I agree, and I conclude that "all
that reasonably can be done" should include, at a minimum, a facility
adhering to its own care plan for a resident. As CMS pointed out "the facility did not provide the routine
preventive care it had itself determined was necessary." CMS's brief at
42. As I discussed above, the facility allowed R15 to languish in bed
linen that was wet with urine, allowed urine and feces on her skin, including
her right foot which had the sore, allowed the dressing on her sore to
become loose and contaminated with urine and feces, allowed R15's foot
with the sore to contact dirty bed linens, and allowed her foot with the
sore to rest sore-side down with no pressure relief device. All of this
was contrary to her care plan. I conclude that Petitioner failed to prevent a preventable pressure sore as required by 42 C.F.R. § 483.25(c).
Under this tag, CMS alleged that three residents, R3,
R13(3), and R15, were not provided adequate
care for their varying degrees of bladder incontinence. CMS offered evidence
that R3, who was continent with toileting, was allowed to wait too long
without toileting which provoked unnecessary episodes of incontinence.
And that R13 and R15, who were incontinent, were allowed to wait too long
before receiving incontinence care, and when they were given the care
it was done incorrectly so as to increase the risk of urinary tract infections
(UTIs). CMS also offered evidence that R13 and R15 suffered from UTIs
frequently. Petitioner made several alternative arguments, which are
distillable to their essence that CMS's witness (the surveyor) made up
her observations, the residents were not left too long without toileting
and/or incontinence care, and the residents suffered no harm. I disagree
with all three of Petitioner's arguments. I find that CMS established
a prima facie case because the evidence shows that the residents were
left in incontinence briefs for long periods of time, and that R13 and
R15 were given incontinence care using a technique likely to exacerbate
the risk of UTIs. And I find that Petitioner failed in its rebuttal to
prove that it substantially complied with the incontinence care requirements
of the three residents. 42 C.F.R. § 483.25(d)(2) requires that a resident who
is incontinent of bladder receives appropriate treatment and services
to prevent urinary infections and to restore as much normal bladder function
as possible. I find the following relevant facts. R3 was continent
when toileted, but, when left for long periods without toileting services,
experienced bladder incontinence. Tr. at 162-64; HCFA Ex. 16 at 1; HCFA
Ex. 18 at 6. R13 was incontinent. Tr. at 382-84; HCFA Ex. 4E at 23. And
R15 was also incontinent. Tr. at 190. According to the care plan devised
for R13, she was supposed to receive pericare promptly after incontinence.
And her skin was supposed to be kept clean and dry. Tr. at 382-84; HCFA
Ex. 4E at 23. R13 had UTIs on June 26, 1997 and April 27, 1998. The infections
were caused by bacteria found in the lower intestine. Tr. at 382, 386-87.
HCFA Ex. 25 at 6. R15, like R13, was supposed to receive prompt pericare
after incontinence. R15 was also susceptible to UTIs. She had a UTI documented
on March 27, 1998 and one on June 27, 1998. Tr. at 192; HCFA Ex. 27 at
10. I find the following facts relating to the residents'
bladder incontinence care. On July 28, 1998, R3 was observed in a chair
in his room for 3 ½ hours, from 12:30 p.m. to 4:00 p.m., without being
toileted or offered incontinence care. He was observed struggling to get
out of the chair and was wearing a soiled incontinence brief. Tr. 165.
The incontinence brief R3 was wearing had "6:25 a.m." written on it. HCFA
Ex. 18 at 19. The writing on the incontinence brief indicated when it
had last been changed or checked. Tr. at 155-56. On July 28, 1998 R3 wore
the same incontinence brief from 6:25 a.m. until 4:00 p.m., without toileting.
Tr. at 340-41. On July 29, 1998, R3 was observed in bed from 9:20 a.m.
to 11:05 a.m. wearing a soiled incontinence brief. Tr. at 166-67. The
brief had "5:50 a.m." written on it. Tr. at 167; HCFA Ex. 18 at 10. No
incontinence service or toileting assistance was provided to R3 between
9:25a.m. and 11:05 a.m. Tr. at 166-67. On July 30, 1998, R3 was observed
from 7:00 a.m.-10:12 a.m. He was not offered toileting or incontinence
care. Tr. at 168-69; HCFA Ex. 18 at 12. On July 30, 1998 R13 was observed sitting in her room
from 7:00 a.m.-1:30 p.m. No incontinence care was provided. Tr. at 171-72,
195, 386; HCFA Ex 18 at 13. At 1:30 p.m. R13 was given incontinence care.
The nurse aide providing the care was observed using an improper technique
to clean R13's perineum. The nurse aide cleaned R13 by wiping forward
from the rectal area towards the urinary tract and perineal area. Tr.
at 385-86; HCFA Ex. 25 at 5. On July 29, 1998, a nurse aide was observed using the same improper cleaning technique on R15, wiping feces forward from the rectal area towards the perineal and urinary tract area. A nurse aide was observed repeating the improper technique two additional times on July 30, 1998. Tr. at 188-90; HCFA Ex. 27 at 6, 8; HCFA Ex. 18 at 12. On July 30, 1998, immediately after R15 was administered incontinence care, it was observed that R15 had urinated and required additional incontinence care. The facility was aware that R15 needed additional cleaning. R15 was not cleaned, and was allowed to remain seated in an unwashed state from 10:25 a.m.-2:00p.m. Tr. at 143-44, 191; HCFA Ex. 27 at 8. From these facts CMS concluded that the failure of the
facility to provide routine toileting caused R3 unnecessary episodes of
incontinence. CMS argues that the long periods of time R3 was allowed
to remain in soiled incontinence briefs, constitute a failure to give
the appropriate services to prevent UTIs and restore as much bladder function
as possible. And this failure had the effect of causing a decline in R3's
ability to remain continent. CMS's brief at 49. Regarding R13 and R15,
CMS concluded that the failure to provide timely care, and the failure
to utilize the proper technique in providing incontinence care to these
residents, placed R13 and R15 at risk for UTIs. CMS's brief at 51-52. Petitioner's response to CMS's contentions is that the
surveyor, Ms. Truett, fabricated the pericare observations because the
residents objected to her viewing them during the care. Petitioner also
argued that one cannot tell how long it has been since an incontinence
brief was changed by how strong the odor is (it was part of Ms. Truett's
observations that one resident had an incontinence brief with a strong
foul odor). Petitioner also seems to argue that the residents' UTIs were
not frequent. Finally, regarding the improper technique that CMS observed
some nurse aides using, Petitioner argued that this presented no risk
of harm absent feces actually entering a resident's urinary tract. See
Petitioner's brief at 10-11; Petitioner's reply brief at 11-12. Taking these arguments in turn, Petitioner argued that
"there is every reason to believe that Ms. Truett fabricated her peri-care
observations." Petitioner's brief at 10. But Petitioner does not elaborate
other than to assert that some residents objected to the surveyor observing
them. In fact, the cite that Petitioner gives to support this contention
in its brief is to "Tr. at 691." That page in the transcript is testimony,
by Petitioner's witness Ms. Jefferson, which supports the conclusion that
the surveyor observed pericare despite the objections of the
residents. I conclude that rather than there being every reason to believe
Ms. Truett fabricated her observations, there are in fact no reasons to
believe she fabricated her observations. Petitioner's contention that one cannot measure how long
an incontinence brief has been worn by a resident judging from the strength
of its odor may be correct. However, although the surveyor included the
strength of the odor in her observations, one can tell with greater certainty
the length of time a resident has been wearing an incontinence brief by
reading the time written on it, then looking at a clock, observing the
resident's care, and questioning the staff. This is the more complete
picture of what happened in this case, notwithstanding the facts Petitioner
emphasizes. As for the assertion that resident's are only placed at
risk when feces actually enters a urinary tract, rather than when a technique
is used which draws the feces from the rectum into the vicinity of the
urinary tract, I am convinced that it is the use of the incorrect technique
itself that causes the risk because the risk is that feces will enter
the urinary tract. I am also convinced that use of the wrong technique
is particularly risky in residents who have recently recovered from UTIs.
Petitioner made no argument which would convince me otherwise, by, for
instance, advancing an argument and or evidence suggesting the technique
used by the nursing aides was proper. Petitioner only presents the unsubstantiated
contention that if feces doesn't enter the urinary tract there is no potential
for any harm. I conclude that the facility failed to ensure that each resident receive appropriate treatment and services to prevent urinary tract infections and to restore as much normal bladder function as possible, as required by 42 C.F.R. § 483.25(d)(2).
Under this F-tag, CMS alleged that R9 suffered actual
harm, and both R9 and R14 were placed at risk for more than minimal harm,
because of the facility's failure to ensure that these residents received
adequate supervision and assistance devices to prevent accidents. The
allegations concerning R9 are that the facility failed to ensure that
he had padded side-rails on his bed. The allegations concerning R14 are
that the facility misused a bed-rail, body-restraint combination of devices
in at least one instance, and, in another instance, misused a pelvic restraint,
thereby placing R14 at risk for serious injury. As discussed below, I
find Petitioner's response, to the effect that R9 was responsible for
placing himself at risk, and that R14 was not at risk, unpersuasive. Accordingly,
I find that the facility was not compliant with its participation requirements
as cited under this F-tag. 42 C.F.R. § 483.25(h) requires that the facility ensure
that each resident receives adequate supervision and assistance devices
to prevent accidents. I make the following findings of fact. R9 took anticoagulant
medication which thinned his blood and increased his blood clotting time.
A physician's order required that R9's side bed rails be padded. Tr. at
125, 670; HCFA Ex. 23 at 2. In addition, R9's care plan required that
two full, padded side rails be provided. HCFA Ex. 23 at 10. On July 28,
1998, R9 was observed both resting his leg and banging his leg on an unpadded
side-rail. HCFA Ex. 18 at 8. Again, on July 29 and 30, 1998, R9 was observed
with his leg resting on an unpadded side-rail. HCFA Ex. 18 at 10, 12.
R9 had a purple indentation, red areas and bruising where his leg rested
on the unpadded rail. Tr. at 125-26, 133; HCFA Ex. 18 at 12. R14 had dementia, delusional disorder, and osteoporosis.
She also had a history of falls resulting in fractures. To protect her,
the facility utilized a pelvic restraint when R14 was sitting upright
in a chair, and a body restraint device, which permitted limited movement,
in combination with side-rails when R14 was lying in bed. Tr. at 129,
131; HCFA Ex. 4E at 85-87. Despite the body restraint, R14 was documented
trying to climb over her bed-rails. Tr. at 130-31; HCFA Ex. 26 at 1-5.
Because R14's bed had a water mattress, and an egg crate pad on top of
a standard mattress, the side-rails were only approximately two inches
above the surface of the bed. Tr. at 87; HCFA Ex. 18 at 20. On July 31, 1998, R14 was observed wearing the pelvic
restraint while seated in a chair. The restraint was incorrectly affixed
to the arms of the chair, instead of the bottom of the chair. Tr. at 406,
408-09. R14 was able to move her arms under the restraint's straps which
caused pressure on her lower thoracic area. Meadow Wood staff correctly
applied the restraint after being notified by the surveyors. Tr. at 381;
HCFA Ex. 18 at 15. From these facts CMS concluded that the
anticoagulant medication increased R9's risk of injuries associated with
his circulation, and increased the possibility of excessive bleeding.
Tr. at 127; HCFA Ex. 23 at 2. CMS claims that R9 suffered actual harm
in the form of the skin indentations and bruising that were observed,
and that the risk of harm due to his thinner blood and slower blood clotting
time attributable to the medication was more than minimal. Petitioner
does not argue that R9 was not on the medication, or that the medication
did not have the thinning and clotting effect on his blood, or even that
he didn't bang his legs or receive bruising and indentations from the
unpadded side-rails. Petitioner argues that R9 removed the physician prescribed
pads to look through the rails, and that he had a perfect right to do
so. Petitioner's brief at 21. CMS counters that, R9's preference notwithstanding, a
facility still has an obligation to protect the resident. Petitioner responds
that R9's physician knew about R9 removing the pad. Petitioner's brief
at 21. While it is true that a facility must respect a resident's
right in some situations to override a physician's order, it is not a
reasonable or responsible position for a facility to do nothing in the
face of self destructive or harmful behavior of a resident. First, I find
the claim that the physician had been properly made aware of R9 removing
the pad dubious. Ms. Jefferson testified that R9's physician had been
apprized of R9's preference against the pad on one side of his bed because
he apparently enjoyed looking through the rail, but there was no documentation
of the physician having been informed about his order not being followed.
So, there is no indication that the facility tried to safeguard this patient
by, at least, documenting the problem with R9's physician. Second, I agree
with CMS that the facility still has a duty to care for the resident despite
the resident's resistance. In this case, one might get the impression
from Petitioner's argument that the facility supplied the rail pads and
the resident promptly removed them. Yet I note that the record does not
indicate that there was a pad present in proximity to the bed which might
suggest it had just been removed. A facility has an obligation to at least
try their best to comply with a physician's order for a resident, but
the lack of a pad nearby suggests that this facility had given up trying
to provide the resident with a pad. Regarding the circumstances of R14 and her body restraint
and bed-rail combination, CMS concluded she was at risk for chest compression,
suffocation and death by sliding over the low bed-rails and getting hung-up
in her body restraint. CMS's brief at 37. Petitioner argued that the restraint
wouldn't allow her to move more than a few toes over the edge while she
was "pinned to the center of her bed." Petitioner's brief at 21. I do
not find this assurance credible. The facility itself documented that
R14 could move significantly more than a few toes over the side-rail,
and she frequently attempted to do so. HCFA Ex. 26 at 5. Therefore, I
agree with CMS that R14 was at risk for more than minimal harm due to
the combination of bed padding, body restraint and side bed-rails. Concerning R14 and the pelvic restraint, CMS concluded
that R14 was at risk for more than minimal harm from the incorrect application
of the pelvic restraint. Specifically, chest compression and broken ribs
in light of her osteoporosis and prior fractures. CMS's brief at 38. Petitioner seems to suggest that, because the resident
was not shown to have respiratory distress, there was no harm or, presumably,
any risk of harm. Petitioner argues that R14 would only have been at risk
for a "wedgie," and that she could not have been asphyxiated or have broken
a rib. And Petitioner appears to suggest that a resident with a pelvic
restraint could not be at risk for both fractures and asphyxia, but rather
one or the other. Petitioner's brief at 20. I find that Petitioner's interpretation
that a "wedgie" was the only possible negative outcome unpersuasive. Petitioner's
view is inconsistent with the undisputed facts that an elderly woman with
dementia, delusions and osteoporosis, was wearing a restraint that was
not applied correctly. Petitioner itself points out that R14 was an "active
lady" (Petitioner's brief at 20) presumably to indicate that she was not
likely to slump into a position were she would asphyxiate herself. However,
I find this "active" characteristic supports a contrary view that an active
person with dementia, delusions and osteoporosis, like R14, is at greater
risk of entangling herself in an improperly applied restraint for the
very reason that she is active and moving around. I conclude that the facility failed to provide R9 and R14 with adequate supervision and assistance devices to prevent accidents, as required under 42 C.F.R. § 483.25(h).
Under this F-tag, CMS alleged that R3, R15, and R10 were
transferred several different times by nurse aides who lifted the residents
while holding them under the arm pits without any support to their lower
bodies. CMS believes that these were improper transfers, which calls into
question whether the facility ensured that the nurse aides demonstrated
competence in this technique, which technique is necessary to properly
care for the residents. Petitioner does not offer evidence to dispute that the
improper transfers of the residents were performed by the nurse aides,
but Petitioner asserts that the regulation only requires that the facility
ensure that nurse aides can demonstrate the proper technique, not that
the facility ensure nurse aides perform the technique correctly in the
course of delivering care to the residents. I disagree with Petitioner
because I interpret the regulation to require the ability to demonstrate
competence in the care of the residents, not just at some initial point.
I also find that the evidence in this case supports a finding that the
nurse aides were not competent in the relevant technique, and I deduce
that the facility did not ensure that the nurse aides demonstrated the
required techniques. Therefore, I concur with CMS that by utilizing improper
transfer techniques, Petitioner put the residents at risk of injury and
did not substantially comply with the regulation. 42.C.F.R. § 483.75(f), requires that the facility ensure
the nurse aides are able to demonstrate competency in skills and techniques
necessary to care for resident's needs, as identified through resident
assessments and described in the plan of care. I find the following facts, which, as I noted above, Petitioner
has not offered evidence to dispute. On July 28, 1998, a nurse aide was
observed transferring R10 during a shower. The nurse aide lifted R10 by
the armpits so that the resident's lower body was not supported. Tr. at
177-78; HCFA Ex. 24 at 7. On July 30, 1998, at different times, nurse
aides were observed using the same axilla lifting techniques on R3 and
R15 (twice). Tr. at 173-76, 195-96; HCFA Ex. 18 at 12; HCFA Ex. 27 at
8. Nurse aides revealed that they were having difficulty transferring
R3 from the chair to the toilet. Tr. at 173-74, 195-96; HCFA Ex. 18 at
2. And both R3 and R10 had been assessed as requiring two staff members
to transfer them supporting both the upper and lower body. Tr. at 175;
HCFA Ex. 24 at 3; HCFA Ex. 40 at 4. CMS argues that the axial transferring technique is improper
because lifting a resident under the axilla can cause bone, soft tissue,
and nerve injuries to the part of the upper body that is grasped by the
nurse aide. And without control of the lower body, a resident's dangling
limbs may swing around causing impact injuries. CMS's brief at 52-54.
CMS concluded from its observations that Meadow Wood failed to ensure
that its nurse aides demonstrated competence in the technique required
to transfer the residents. Petitioner does not dispute that the axial transfers took place, or that axial transfers are an improper technique. But Petitioner argues that the regulation CMS cites does not require proper transfer techniques in practice, only that the nurse aides be able to demonstrate the proper technique. The language in the regulation requires that:
Petitioner argues that the plain meaning of the word "demonstrate"
means show competence at some initial point, not necessarily exhibit competence
in the day-to-day provision of care. Therefore, Petitioner wishes me to
conclude that CMS has not introduced evidence that there was no point
at which the facility ensured nurse aides could demonstrate the proper
transfer technique. I disagree with this narrow interpretation of the
regulation. The cannons of construction require me to give effect
to all the language in the regulation, not an isolated phrase or word
disembodied from the whole section. The regulation also says that the
demonstration of techniques which facilities are supposed to ensure are
the ones "identified through resident assessments, and described in the
plan of care." This language must be given effect. I conclude that it
means that the facility must ensure that the nurse aides can do the things
identified and described in the assessments and plans of care for the
individual residents. This language suggests that the Secretary envisioned
the ability to demonstrate the skills and techniques coming after the
identification and description of the required skills and techniques.
Not at some initial point, perhaps the beginning of a nurse aides' employment,
with no requirement that there be any subsequent ability to demonstrate,
but during the care of the individual residents. Looking at the regulation this way, I agree with CMS's
interpretation of the regulation that a nurse aide exhibits the ability
to demonstrate the techniques and skills "not by passing a test, but by
actually using the requisite skills in actual patient care." CMS's brief
at 55, f.n. 54. Accordingly, in this case, the facility was required to
ensure that the nurse aides could demonstrate the proper technique for
the transfer of R3, R10, and R15, as required by the facility's assessment
of those residents. Even if I ascribed to Petitioner's interpretation
of the regulation, the numerous incorrect transfers observed in a short
period of time constitute a prima facie case that the facility never ensured
the nurse aides could demonstrate the technique - even at some initial
point before actual care of the residents began. This prima facie case
is not rebutted. The essence of this regulation is that a facility ensure
that the nurse aides show that they know how to take care of the residents
they are actually caring for. The record in this case indicates that the
facility did not ensure that the nurses aides demonstrated competence
in the proper skills and techniques needed by R3, R10, and R15. This is
evident because the nurse aides were observed consistently using improper
skills and techniques on the residents. Contrary to Petitioner's assertion,
this interpretation does not constitute a requirement that nurse aides
can never use an improper technique, because the facts in this case, cumulatively,
tend to indicate that the nurse aides did not know how to do the technique
at all. Petitioner has introduced no evidence from which I can infer that
the improper techniques were aberrations performed by nurse aides who
were otherwise competent in the appropriate transfer techniques. Accordingly, I conclude that the facility failed to ensure the nurse aides were able to demonstrate competency in skills and techniques necessary to care for resident's needs, as identified through resident assessments and described in the plan of care, as required by 42 C.F.R. § 483.75(f).
Under this F-tag, CMS alleged that the facility failed
to store, prepare, distribute, and serve food under sanitary conditions,
as required by 42 C.F.R. § 483.35(h)(2). CMS maintains that an inspection
of the facility's kitchen turned up numerous sanitation problems related
to food storage and kitchen equipment. I find that CMS did uncover substantial
sanitation problems, but, as discussed below, I discount several of the
examples cited as unsubstantiated. The relevant facts I find are that on July 29, 1998 the
facility's kitchen was surveyed. Tr. at 357; HCFA Ex. 20. There was undated,
unlabeled, and unwrapped meat in one freezer. The dietary manager did
not know what kind of meat some of the packages contained. Some pork and
beef stored in plastic bags had ice build-up on it. Some frozen vegetables
in the freezer were not dated. A container of frozen orange sections was
dated July 17. Tr. at 359-61, 364-65, 393-94. The facility ordered food
for the kitchen every 7-12 days. Tr. at 694-95, 792-93. Next to an open
door there was an open box of parboiled rice on a pallet, a box of crackers,
a box of cracker crumbs, and open bins of potatoes and onions. Tr. at
366-67, 395-96. The door was propped open to dry because it had been recently
painted. Tr. at 394. The kitchen sink was observed to have only cold running
water. Tr. at 368. The counter-mounted can opener had
rust and built-up black debris on the blade. Tr. at 358-59. Coffee cups
removed from a dishwasher at 10:05 were still wet on the inside at 11:30.
Tr. at 370-71. CMS says that the surveyor, Ms. Tucker, relied on State
and federal guidelines to ascertain what food service practices are sanitary.(4)
CMS's brief at 57. CMS cited HCFA Exs. 33, 34, and 39 at 14-17. My review
of Ms. Tucker's testimony indicates that Ms. Tucker testified "[t]here
is [sic] food service laws that all facilities that serve food must also
abide by - that are produced by the state department of health." Tr. at
355. The state "food service laws" were provided by CMS in HCFA Ex. 33.
HCFA Ex. 34 is a "critical control point inspection" document, and it
is a document from the Ohio State Department of Health. Tr. at 356. Ms. Tucker relied on the food service laws to conclude
that debris she found on the can-opener created a risk of food contamination.
Tr. at 358-59. Ms. Tucker also relied on the food service laws to conclude
that meat she observed in packages that were not labeled or dated was
not appropriate. Ms. Tucker concluded that the meat, which she found to
have a build-up of ice on it, would have the flavor, texture, and nutritive
value affected. Tr. at 360. Ms. Tucker also was concerned that frozen
orange segments labeled July 17 (the inspection was taking place on July
29) could have flavor, texture, and nutritive degradation similar to the
meat. Tr. at 365. Ms. Tucker's concern regarding the onions, potatoes,
and other foods stored on a pallet near the open door was that "[t]he
potential for rodents or insects to enter through that open doorway to
the outside and outside that door is like an open field type of area,
so you are introducing that possibility." Tr. at 367. The food service
laws also address the lack of hot or warm water in the hand washing sink.
Ms. Tucker relied on this to support her conclusion that the lack of hot
or warm water in the sink was a sanitary problem because warm water "breaks
down contaminates." Tr. at 368-69. As for the final instance of purported
unsanitary conditions, the coffee cups that had water droplets in them,
Ms. Tucker failed to tie this observation to any of the exhibits. Tr.
at 370-71. Although, HCFA Ex. 33 at 5, appears to address the air-drying
of equipment and utensils. I accept the requirements in the State food service laws
as persuasive of what constitutes sanitary food storage, preparation,
distribution, and service. Taking the allegations in turn, CMS concluded, based on
Ms. Tucker's observations that, some frozen meat was losing nutritional
value. CMS's brief at 56-57. Petitioner counters that the facility ordered
food every 7-12 days and ordered just enough to be consumed before the
next order. Petitioner's brief at 13-14. Petitioner's contention may be
beside the point, because it is not clear to me from the record that this
is an instance of a sanitation matter. While the point is well taken that
the degradation of texture, taste, and nutritional value have ramifications
in a nursing environment (See Tr. at 366), it appears to me that sanitation
has to do more with the rotting, or contamination of food. CMS has introduced
no evidence regarding the frozen meat, or the frozen orange sections,
from which I can infer there was a cleanliness, rotting, or contamination
problem. At least regarding those instances, I do not find CMS has presented
a prima facie case under this F-tag. Similarly I do not find that the food stored by the door
which had been temporarily propped open to allow paint to dry, is indicative
of any risk to the residents. Ms. Tucker indicated in her testimony that
there was the "possibility" of contamination of the food. The facts show
me that this "possibility" seems very remote indeed. There is no indication
in the record how long the door was open, or whether there were insects,
or rodents poised just outside waiting to get in. Under the circumstances,
a finding that this showed an unsanitary condition would be tantamount
to requiring that food not be stored on pallets (CMS does not argue for
this interpretation), or that a door to the outside not be allowed to
be opened when food is present in the kitchen. I am not prepared to entertain
so stringent a view, and therefore I find that CMS has not made out its
prima facie case regarding this instance either. The same holds for the coffee cups. I note that the food
service rules require that "[g]lasses and cups shall be stored inverted
on a clean, nonabsorbent surface." HCFA Ex. 33 at 5. And the record indicates
that this is precisely how the coffee cups in question were stored. CMS
does not indicate any other source for the contention that the facility
did something improper by storing the coffee cups with some moisture still
in them. I conclude, based on the evidence in the record, that CMS has
not presented a prima facie case that the storage of the coffee cups exemplifies
noncompliance. In the instances of the debris on the can-opener and the
lack of warm or hot water in the hand washing sink, CMS has presented
a better case for noncompliance. It was not disputed that there was black
build-up on the can-opener. This is more clearly a matter of sanitation,
and CMS is the more persuasive because the State food service laws directly
address build-up on the non-food contact surfaces of equipment. HCFA Ex.
33 at 5. Similarly, CMS presented evidence that there was no hot or warm
water in the hand washing sink, and there is a State law buttressing that
the lack of hot water contributes to unsanitary conditions. I find that CMS made a prima facie case that there was
a problem with the can opener and the hand washing sink. I find Petitioner
introduced no evidence to counter CMS's case, relying instead on the statement
that "there is nothing improper with a hand washing sink having only cold-running
water at all." Petitioner's brief at 14. And at the same time arguing
that there was a hot water line in the kitchen serving all outlets (Petitioner's
reply brief at 15), despite the plan of correction indicating that the
hand-washing sink had to be repaired so that it had hot running water.
HCFA Ex. 4E at 93. Accordingly, I conclude that the facility failed to store, prepare, distribute, and serve food under sanitary conditions, as required by 42 C.F.R. § 483.35(h)(2).
This F-tag concerns whether R3, who had contractures and
was assessed as needing range of motion therapy, was given the range of
motion services he was assessed as needing. The issue is not, as Petitioner
seems to indicate in its brief (Petitioner's brief at 11-12), whether
there was adequate range of motion staffing at the facility, or whether
R3 developed new contractures while under the facility's care. The issue
is whether R3 was given the appropriate range of motion services. As discussed
below, I find that he was not. The relevant language in 42 C.F.R. § 483.25(e)(2) is :
The relevant facts concerning this F-tag are that R3 had
a contracted leg. Tr. at 202. It was determined by the facility that he
needed restorative nursing staff services for passive range of motion
to his extremities. The facility determined that R3 would receive passive
range of motion exercises 3-5 times per week to increase his range of
motion. Tr. at 198-99, 561; CMS Ex. 22 at 15. During the survey the facility
provided the surveyors a list of residents who were receiving restorative
services. R3 was not on the list. Tr. at 200-01, 317, 561; HCFA Ex. 18
at 17. Staff indicated to the surveyors that they did not know R3 was
supposed to be on a planned restorative program. Tr. at 201; HCFA Ex.
22 at 1. R3 was not being provided range of motion services for his contracted
leg in accordance with a restorative nursing plan. Tr. at 577. CMS argued that the facility's failure to provide R3 range
of motion services posed the risk of more than minimal harm to him. CMS's
brief at 55. Petitioner claims that CMS is mistaken that the facility
failed to provide the care, because R3 actually received range of motion
care with his regularly scheduled bath. Petitioner's brief at 12. CMS
counters that the claim R3 was given range of motion services with his
regularly scheduled bath is dubious, and even if some range of motion
was provided with R3's baths, that care would fall short of the care offered
in a restorative nursing program which his assessment required he have. The reason the claim that R3 was receiving sufficient
range of motion services with his bath is doubtful is that, as discussed
in the previous section concerning hygienic care, R3 was observed not
being bathed as scheduled. On at least three days R3 received no range
of motion services because on two days, July 28 and 29, he was not bathed.
And on July 30, when the surveyor observed his bath, no range of motion
services were observed. This makes it seem unlikely that R3 was receiving
any range of motion care, and certainly not the specialized range of motion
care he was assessed as needing and which was supposed to be provided
by the restorative nursing program. I conclude that CMS presented a prima facie case that
R3 was not being given the specialized range of motion services he required,
or, for that matter, any range of motion services, as Petitioner asserted
he was. Petitioner has not convinced me that the facility substantially
complied with the requirement that this resident be given range of motion
services or that he was not at risk for more that minimal harm. Accordingly, I conclude that the facility failed to provide R3, who based on the comprehensive assessment, required range of motion services, with appropriate treatment and services to increase range of motion and/or to prevent further decrease in range of motion as required by 42 C.F.R. § 483.25(e)(2).
I next consider whether CMS's immediate jeopardy finding
is "clearly erroneous." 42 C.F.R. § 498.60(c)(2). Immediate jeopardy exists
if the facility's noncompliance has caused or is likely to cause "serious
injury, harm, impairment, or death to a resident." 42 C.F.R. § 488.301. As discussed in section IV. A. 1., I concluded that Petitioner
was not substantially complying with 42 C.F.R. § 483.25(h)(1) from the
time that R2 fell out of his bed on July 23, 1998, until the surveyors
were presented with a list of beds that had been checked, and, where necessary,
fixed, on August 1, 1998. My conclusion that the facility was not in substantial
compliance was based on my findings that residents in the facility were
exposed to accident hazards created by bed rails. The rails were found
to be wobbly and loose, some had loose screws and bolts, and at least
one was prone to collapse. The rail that was prone to collapse caused
actual harm to R2, a 100-year-old man, who fell and sustained injuries.
Additionally, some beds were found to have gaps between the rails and
mattresses which created a risk of death, or of lesser injury by entrapment.(5)
For these reasons, I conclude that the facility's level of noncompliance
posed immediate jeopardy to resident health and safety. I conclude that CMS's determination of immediate jeopardy is not clearly erroneous. Beginning July 23, 1998 and continuing through August 1, 1998, Petitioner failed to comply with the requirements of 42 C.F.R. § 483.25(h)(1) at the immediate jeopardy level.
As discussed above, I uphold CMS's determination that Petitioner was deficient at the immediate jeopardy level for 10 days from July 23, 1998 through August 1, 1998. Therefore, the CMP of $3050 per day is per se reasonable as a matter of law because it is the lowest amount possible under the regulations. 42 C.F.R. § 488.438 (a)(1). In my ruling dated June 18, 2000, I granted CMS's motion for partial summary affirmance, and summarily affirmed the DPNA from September 29, 1998 through December 1, 1998. I also summarily affirmed the $50 per day CMP for the period from July 23, 1998 through December 1, 1998. I instructed Petitioner that while the amount of the CMP for the seven nonimmediate jeopardy tags could not be reduced or eliminated, there was the possibility I would decide to increase the CMP amount if the evidence at hearing warranted. I am not convinced that an increase is warranted in the nonimmediate jeopardy CMP. |
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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. 1 CMS identifies deficiencies in compliance with specific requirements set forth in 42 C.F.R. Part 483, Subpart B, by number, and refers to them as "F-tags." 2. 2 Because the exhibits were admitted as "HCFA exhibits," to stay consistent, I refer to them as "HCFA Exhibits," not "CMS exhibits." 3. 3 In Petitioner's brief it refers to R1 when it appears to mean R13. 4. 4 I take notice that the American Heritage Dictionary defines "sanitary" as it relates specifically to food as "[f]ree from elements, such as filth or pathogens, that endanger health; hygienic." The American Heritage Dictionary of the English Language, Fourth Edition, Houghton Mifflin Company (2000). 5. 5 In Wellington Specialty
Care Rehabilitation Center, DAB CR548 (1998), for instance, the ALJ
found that: . . . side-rails can be dangerous to residents
of long-term care facilities. There exists a risk that some residents
under certain circumstance may suffer injuries from side-rails . . . on
occasion, individuals have become wedged in the gaps between side-rails,
resulting in injuries or death to those individuals . . . . In that same decision, the judge went on to say that: On August 21, 1995 the Food and Drug Administration (FDA) sent an "alert" to hospitals and long-term care facilities which warned them of the dangers that bed side-rails posed . . . This alert stated that since January, 1990, the FDA had received 102 reports of incidents involving entrapment of individuals in hospital bed side-rails . . The FDA noted that it had received reports of 68 deaths, 22 injuries, and 12 entrapments withoutinjuries occurring in hospitals, long-term care facilities, and private homes . . . | |