Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Civil Remedies Division

In the Case of: )
)
Oxford Manor, ) Date: November 09, 2007

(CCN: 34-5291) )
)
Petitioner, )
)

-Vv.- ) Docket No. C-06-665

) Decision No. CR1686
Centers for Medicare & Medicaid )
Services. )
a )

DECISION

I sustain the determination of the Centers for Medicare & Medicaid Services (CMS) to
impose remedies against Petitioner, Oxford Manor, consisting of: civil money penalties
of $3,050 per day for each day of a period that began on April 26, 2006 and which
continued through June 21, 2006; and $50 per day for each day of a period that began on
June 22, 2006 and which continued through July 22, 2006.

I. Background

Petitioner is a skilled nursing facility in North Carolina. It participates in the Medicare
program. Its participation in Medicare is governed by sections 1819 and 1866 of the
Social Security Act and by federal regulations at 42 C.F.R. Parts 483 and 488. Its right to
a hearing in this case is governed by federal regulations at 42 C.F.R. Part 498.
2

On June 21-22, 2006 Petitioner was surveyed to determine whether it was complying with
Medicare participation requirements (June survey). The surveyors determined that
Petitioner was noncompliant. The deficiencies identified by the surveyors included
failures by Petitioner to comply that were so egregious as to comprise immediate jeopardy
for Petitioner’s residents.' CMS accepted the surveyors’ findings and determined to
impose the remedies that I describe above.

Petitioner requested a hearing and the case was assigned to me for a hearing and a
decision. I held an in-person hearing in Raleigh, North Carolina, on August 14, 2007. I
received into evidence exhibits from CMS which I identified as CMS Ex. 1 - CMS Ex.
39. I received into evidence exhibits from Petitioner which I identified as P. Ex. 1 - P.
Ex. 36. Additionally, I heard the cross-examination and redirect testimony of the two
surveyors who conducted the June survey.” Each party filed a post-hearing brief. The
parties received a copy of the hearing transcript. (Tr.)

II. Issues, findings of fact and conclusions of law
A. Issues
The issues in this case are whether:

1. Petitioner failed to comply substantially with one or more Medicare
participation requirements;

2. Petitioner proved that CMS’s determination of immediate jeopardy was
clearly erroneous;

3. Petitioner proved that CMS’s determination of duration of
noncompliance was incorrect;

4. CMS’s determination to impose civil money penalties against Petitioner
in amounts of $3,050 and $50 per day was reasonable.

' The term “immediate jeopardy” is defined at 42 C.F.R. § 488.301 to mean:

a situation in which the provider’s noncompliance with one or more
requirements of participation has caused, or is likely to cause, serious
injury, harm, impairment, or death to a resident.

° The written direct testimony of the two surveyors is in evidence as CMS Ex. 38
and CMS Ex. 39.
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B. Findings of fact and conclusions of law

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 separate heading. I discuss each Finding in
detail.

1. Petitioner failed to comply substantially with Medicare participation
requirements.

The June survey report alleges that Petitioner failed to comply substantially with three
distinct Medicare participation requirements. P. Ex. 1, at 1-47. Two of the deficiencies
cited in the report were at the immediate jeopardy level. These were alleged failures by
Petitioner to comply with the requirements of 42 C.F.R. §§ 483.25(h)(1) and (h)(2). In
this decision I find that Petitioner failed to comply substantially with each of these two
regulations.

I do not address the third deficiency cited in the June survey report, an alleged non-
immediate jeopardy level failure by Petitioner to comply substantially with the
requirements of 42 C.F.R. § 483.15(g)(1), because CMS failed to provide me with any
argument about it in its brief. However, the remedies that I sustain in this decision do not
depend on the presence of this third alleged deficiency.

a. Petitioner failed to comply substantially with the requirements
of 42 C.F.R. § 483.25(h)(1).

The regulation that is at issue here requires that a facility ensure that its residents’
environment remain as free of accident hazards as is possible. It has been the subject of
much litigation. It is settled that the regulation requires that a facility take all reasonable
measures to protect its residents against accident hazards that are known or are
foreseeable.

CMS’s allegations of noncompliance with the regulation center around the care that
Petitioner gave to a resident who is identified as Resident #10 in the June survey report.
CMS alleges, specifically, that Petitioner failed to protect its residents from accident

> CMS did not introduce the actual June survey report as evidence in the case.
Instead, it offered a document which appears to be a restatement of two of the
deficiencies that were identified in the June survey report. CMS Ex. 2. Petitioner
introduced the June survey report as P. Ex. 1. The portions of the two documents that
state the allegations of deficiencies do not appear to differ materially. For purposes of
clarity I cite to P. Ex. 1 as the June survey report.
4

hazards in that it failed to remove a cigarette lighter from the resident’s possession after
the staff discovered that a wander guard that had been attached to the resident had been
burned off. P. Ex. 1, at 4.4

The facts establishing Resident #10’s physical and mental condition are not in dispute.
Petitioner’s records show that the resident was, as of his admission to Petitioner’s facility
and thereafter, an individual suffering from dementia and memory problems. The
resident was first admitted to Petitioner’s facility at the end of November 2005 and his
diagnoses upon admission included a diagnosis of Alzheimer’s Disease. P. Ex. 1, at 5. In
June 2006, only weeks prior to the June survey, Petitioner’s staff assessed the resident as
having an unsteady gait and having mental deficits which included short and long term
memory problems and poor decision making ability. Jd. The staff concluded that the
resident needed cues and supervision to compensate for his mental deficits. Id.

CMS bases its case for noncompliance on the undisputed facts that I have just described
and on the following additional facts. At the June survey a surveyor interviewed
members of Petitioner’s staff concerning the care that was given to Resident #10. Among
those interviewed was a nurse’s aide who avowed to the surveyor that, about two months
prior to the survey, he found a burned wander guard under the resident’s bed. The aide
asserted that, previously, the resident had worn the wander guard around his ankle, and he
concluded that the resident had burned the device off. P. Ex. 1, at 5.

Interviews with other members of Petitioner’s staff revealed that the resident was a heavy
smoker who was supplied cigarettes and smoking materials by members of his family.
According to the staff the resident would go into the facility’s courtyard independently
and smoke several times during each work shift at the facility. P. Ex. 1, at 6. A nurse’s
aide averred that the resident had his own cigarette lighter up until about two weeks prior
to the June survey. Jd. Another nurse’s aide told the surveyor that the resident’s room
smelled of cigarette smoke and that there were cigarette butts on the resident’s table. Jd.
Another member of Petitioner’s staff averred that the resident always kept cigarettes and
a lighter on his bedside table. /d., at 9.

During the survey a surveyor visited the resident’s room. She discovered smoking
materials on the resident’s night stand. Tr. at 14. The room smelled of smoke. Id.

+ A wander guard is a bracelet that a resident wears around his or her wrist or
ankle. It contains an electronic device that triggers an audible alarm if a resident who is
wearing the wander guard attempts to walk through a doorway containing a sensor that
responds to the device.
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Petitioner’s business manager averred in an interview that the staff had brought the
burned wander guard to him/her on the date that it had been discovered and that he/she
brought the matter to the attention of Petitioner’s director of nursing. P. Ex. 1, at 6.
Petitioner’s director of nursing, however, claimed no independent memory of having been
told about the burned wander guard. /d. at 7. Petitioner’s administrator stated in an
interview that he was unaware before June 20, 2006, that Resident #10’s wander guard
had been burned off. Jd.

Nothing in Petitioner’s records show that Petitioner’s staff documented the wander guard
incident. See P. Ex. 1, at9. Furthermore, Petitioner’s staff did not perform an assessment
between his admission to the facility on November 30, 2005 and the June survey of the
need to supervise Resident #10 while he smoked. See Jd.

Petitioner has a policy governing smoking by its residents. Among other things, this
policy states:

1. The IDT (Interdisciplinary Team) shall make a determination as to the
competency of residents who smoke, based on a written assessment, on
admission and at least quarterly thereafter.

2. A care plan that outlines appropriate interventions to ensure the safety of
residents who smoke will be completed with the assessment.

3. Residents who are determined by assessment to be incompetent smokers will
not be permitted to smoke without the direct supervision of a staff member, family,
visitor or volunteer who has been trained in their responsibilities for this task.

4. Residents who are determined by assessment to be competent will be
permitted to smoke in designated areas without direct supervision. They
may be permitted to retain cigarettes, but lighters or matches must be
secured by staff members when not in use by the resident. In no event is any
f{l]ame-producing device to be left in resident rooms or common areas,
including the designated smoking areas. ...

P. Ex. 13, at 1-2 (emphasis added). Petitioner’s smoking policy also instructs staff to
“check bedside area[s] and throughout room routinely for lighting materials.” Jd. at 2.

The evidence offered by CMS concerning Petitioner’s care of Resident #10 establishes a
strong prima facie case that Petitioner’s staff failed to protect residents from accident
hazards. Resident #10 is a demented individual suffering from memory and judgment
problems. Petitioner’s staff knew that he was a habitual smoker and knew that the
resident kept smoking materials in his room including a cigarette lighter. The resident’s
6

possession of a lighter was an obvious hazard given his dementia and, in fact, was in
violation of Petitioner’s own smoking policy. Yet, Petitioner’s staff failed to take the
lighter away from the resident even after the staff discovered that the wander guard that
the resident wore had been burned off and placed under the resident’s bed. Indeed, the
evidence supports a finding that the resident continued to smoke in his room,
unsupervised, up until the June survey. Tr. at 14.

The failure to protect Resident #10 is a basis for me to infer a lack of understanding by
Petitioner’s staff of their obligation to protect residents — not just Resident #10 — from
known hazards. The failures documented by CMS with respect to the resident are
evidence of a systemic problem. That is because the evidence shows that Petitioner’s
staff failed consistently to provide necessary protection to the resident. Based on this
evidence the staff failed to: conduct requisite assessments of the resident; prevent the
resident from keeping and using prohibited smoking materials in unsafe areas; take away
these materials after being made aware of an incident that illustrated the danger of leaving
the resident with them unsupervised; and, investigate the incident itself.

Petitioner makes several arguments in opposition to CMS’s case for noncompliance. I
find them to be unpersuasive.

Petitioner asserts that “neither the Statement of Deficiencies [the June survey report] nor
CMS’s arguments and its witnesses’ testimony make clear exactly what the purported
noncompliance was in this case.” Petitioner’s post-hearing brief at 2. I do not understand
this argument. As I discuss above, CMS’s allegation of noncompliance with the
accidents hazard prevention regulation is precise. The June survey report states explicitly
that Petitioner failed to remove a cigarette lighter from Resident #10 after the staff
discovered that a wander guard worn by the resident had been burned off.

Perhaps related to this assertion is Petitioner’s contention that:

the regulatory bar now is so low that the [Departmental Appeals] Board will
sustain virtually any CMS allegation of wrongdoing, whether the evidence
actually supports a surveyor’s allegations or not....

Petitioner’s post-hearing brief at 4. That complaint is, of course, meaningless when
uttered in the context of a specific case unless it relates to the evidence and arguments
that are made in that case. The evidence that I describe above “actually supports” the
allegations of noncompliance made by CMS. It is incumbent on Petitioner, if it wishes to
prevail, to do more than to carp about the Departmental Appeals Board’s standards of
review. Petitioner must rebut CMS’s evidence with credible evidence of its own. As I
discuss below, Petitioner failed to meet that obligation.
7

Petitioner asserts that there is no evidence that Resident #10 habitually and consistently
smoked without adequate staff supervision over a period of months. Petitioner’s post-
hearing brief at 2. Indeed, according to Petitioner, its witnesses denied that assertion.
But, Petitioner’s assertions to the contrary, there is very strong evidence to support a
finding that the resident smoked consistently without staff supervision. That evidence
includes interviews with facility staff who averred that they found cigarette butts in the
resident’s room and that the resident’s room smelled of smoke. P. Ex. 1, at 6.
Additionally, the resident’s wife, who was also the resident’s roommate, told a surveyor
that Resident #10 frequently smoked in the bathroom of his room. Jd. at 8-9. And, the
surveyor found evidence that the resident was still smoking in his room consisting of
cigarette butts and the odor of cigarette smoke.

Petitioner’s assertions aside, it presented no testimony to show that Resident #10 was
supervised adequately by Petitioner’s staff. Petitioner presented no testimony to show
that the staff acted to remove prohibited items from the resident in the face of knowledge
that he possessed them.

Petitioner supported its case with the written direct testimony of four witnesses. P. Ex. 33
- P. Ex. 36. These individuals include Petitioner’s director of nursing, Petitioner’s
administrator, a licensed practical nurse, and a nursing assistant. Jd. Only one of these
witnesses makes any reference to Resident #10’s smoking behavior. That witness is
Rhonda Foster, R.N., Petitioner’s director of nursing. P. Ex. 33. In her testimony she
avers that she was “unaware that the Resident ever smoked in a way that was dangerous
to himself or others.” Jd. at 4. But, this conclusion aside, Ms. Foster does not deny the
reported statements of various staff and the resident’s wife that Resident #10: kept a
cigarette lighter in his possession in express violation of Petitioner’s smoking policy; and
smoked in his room also in violation of that policy. Nor does Ms. Foster explain why the
resident was allowed to retain possession of the lighter after his wander guard had been
discovered by staff to have been burned off. Her only testimony about that is that her
“understanding is that the Resident was counseled about the matter, and he never
attempted to do so again.” Jd.

Ms. Foster’s testimony fails to address the very specific allegations made by other staff
members and the resident’s wife concerning Petitioner’s failure to supervise the resident.
She does not testify that she personally supervised Resident #10 and she does not detail
the supervision that allegedly was provided to the resident. Moreover, she does not
explicitly deny the surveyor’s reported conversation with her in which she stated that she
did not remember being told about the burned wander guard. P. Ex. 1, at 7. And, the
alleged supervision that Ms. Foster testifies to is inadequate on its face given the obvious
hazard that the staff was aware of concerning Resident #10’s smoking. She provides no
explanation for the staff’s failure — in contravention of facility policy — to assess the
resident’s ability to smoke after his initial admission to the facility despite the staffs
knowing that the resident was demented and had significant memory and judgment
problems.’ She does not explain why the resident continued to be allowed to smoke in his
room after the staff became aware that he was doing so. She offers no explanation for the
staffs failure to take away the resident’s cigarette lighter after the staff discovered that he
possessed one. And, she offers no explanation for the staff’s failure to take more
aggressive action to protect the resident after the staff discovered that the resident’s
wander guard had been burned off.

Petitioner suggests, without offering any evidence to support its speculation, that there is
no basis to conclude that the resident burned off his wander guard. The reasonable
inference, of course, is that he did burn off his wander guard given that it was found
under his bed and given further his dementia and his unsupervised use of a cigarette
lighter. But, it really is not important to my conclusion that Petitioner was non-compliant
to establish that Resident #10, as opposed to someone else, burned off the wander guard.
The fact that the wander guard was burned off, whether by the resident or by some
unknown individual, was a graphic reminder to Petitioner’s staff that the resident
possessed a cigarette lighter. That event, in addition to the staff's knowledge of the
resident’s dementia and Petitioner’s own policy which expressly prohibited even
competent residents from possessing lighters, should have galvanized the staff into taking
action to protect the resident.°

Petitioner also seems to suggest that the cigarette butts that were present in the resident’s
room are unreliable evidence that he smoked in his room. Petitioner speculates, again
without offering any supporting evidence, that the resident may have collected the butts
elsewhere and brought them back to his room. This unsupported suggestion
notwithstanding, the reasonable inference that I draw from the presence of those butts in

> Petitioner attempts to make a silk purse out of a sow’s ear by asserting that,
although its staff failed to make requisite quarterly assessments of the resident’s ability to
smoke, it is possible to “infer that the resident’s cognitive status was stable.” Petitioner’s
post-hearing brief at 8. But “stable” does not mean “safe.” Resident #10 had obvious
judgment problems, recognized by Petitioner’s staff, which made assessing his ability to
smoke safely mandatory. The discovery of the burned wander guard only served to
underscore the extent of those problems.

® The possibility — raised by Petitioner — that someone other than Resident #10
may have burned off the wander guard is highly disturbing. Petitioner, in effect, argues
that some individual besides the resident, clearly capable of taking actions that might
have caused great harm to residents, was acting undetected in the facility. Yet, despite
that possibility, Petitioner’s staff did nothing to investigate the circumstances surrounding
the burned wander guard. Indeed, Petitioner’s administrator was unaware of the incident
until shortly prior to being interviewed by a surveyor.
9

the resident’s room is that he smoked in his room. That inference is supported by the
unrebutted statement of the resident’s wife who averred to a surveyor that the resident
smoked in his bathroom. And, it is also supported by staff and surveyor assertions that
the resident’s room smelled of smoke.

Moreover, whether the resident actually smoked in his room is, in fact, a secondary issue.
Petitioner’s staff knew that the resident — a demented individual — possessed a cigarette
lighter in his room. The staff also knew that the resident’s wander guard had been burned
off and they had strong evidence that this incident had occurred in the resident’s room
given that the wander guard was found under the resident’s bed. And, yet, the staff did
nothing to investigate the incident or even to remove the lighter from the resident’s
possession after the burnt wander guard was discovered.

Petitioner argues also that the resident’s smoking at Petitioner’s facility should be

considered in context. It asserts that the resident was experiencing adjustment problems
while at Petitioner’s facility and that smoking was a central part of his life. Petitioner’s
post-hearing brief at 10-12. Consequently, according to Petitioner:

Resident #10 was not some academic or hypothetical case study; he was a
gentleman whose agitation and adjustment problems were so severe that it
would have been cruel for Petitioner’s staff to treat him like a child or
punish him each time that he smoked indoors during the first few weeks of
his stay simply because they feared that a surveyor might second-guess
their clinical decisions a few months later.

Id. at 11-12. This argument is a straw man. The evidence offered by CMS and not
rebutted by Petitioner establishes that Petitioner’s staff allowed the resident to possess
prohibited smoking material and to smoke, essentially unsupervised, not weeks, but
months after his admission to Petitioner’s facility. Furthermore, the choice that Petitioner
claims was presented to the staff — to allow a demented resident to possess prohibited
materials and to smoke largely unsupervised or to “treat him like a child or punish him
indoors during the first few weeks of his stay”— is a false choice. Petitioner’s staff never
faced the option of treating Resident #10 as a child or punishing him for smoking.
Petitioner’s own smoking policy established clear guidelines which enabled residents to
smoke under adequate supervision given their mental and psychological states. Petitioner
could have protected the resident adequately, consistent with respecting the resident’s
dignity, had it simply followed its own policy.
10

The concern that Petitioner now expresses for the resident’s fragile psychological state is
ironic given that Petitioner’s staff did not manifest sufficient concern for the resident after
his admission to perform the assessments of his psychological and mental capacity to
smoke that Petitioner’s policy required. It is ironic also given that Petitioner’s staff failed
to express much concern for the resident’s physical safety.

b. Petitioner failed to comply substantially with the requirements
of 42 C.F.R. § 483.25(h)(2).

The regulation that I address here is closely related to the regulation that I discuss in the
previous subsection. It mandates a facility to provide each of its residents with adequate
supervision and assistance devices to prevent accidents. The standards for complying
with this regulation are well-established and closely track the compliance requirements of
42 C.F.R. § 483.25(h)(1). A facility must provide all reasonable supervision and
assistance to a resident in order to protect that resident from any foreseeable accident.

CMS premises its contention that Petitioner failed to comply substantially with the
requirements of 42 C.F.R. § 483.25(h)(2) on three allegations that Petitioner inadequately
supervised or assisted residents. These are that Petitioner’s staff failed to:

* supervise Resident #10’s possession of a lighter after the resident’s wander guard
had been discovered burned off;

* monitor Resident #10’s wandering sufficient to prevent him from eloping
Petitioner’s premises; and

* monitor another resident, identified in the June survey report as Resident #5,
sufficiently to protect her from eloping Petitioner’s premises.

P. Ex. 1, at 14.

I have discussed in detail at subpart a. of this Finding the failure of Petitioner’s staff to
protect Resident #10 against the hazards caused by his possessing prohibited smoking
materials. I do not need to discuss this failure again in detail here to conclude that the
staff failed to supervise Resident #10 as is required by 42 C.F.R. § 483.25(h)(2).
Petitioner’s staff knew that the resident was demented. The staff knew also that the
resident had a propensity to smoke constantly, they knew that he possessed a lighter
contrary to facility policy, and they had reason to conclude that he was smoking,
unsupervised in locations where smoking was prohibited, including his room. Tr. at 14.
But, in the face of that knowledge, the staff did essentially nothing to protect the resident.
The staff failed to conduct smoking safety assessments required by Petitioner’s own
policy. They failed to remove a lighter from the resident’s possession after they learned
11

that he had it and after they had every reason to believe that he’d used it to burn off a
wander guard. And, they continued to allow the resident to smoke unsupervised in
locations that included his room. Jd.

Petitioner argues that its staff supervised the resident effectively. According to Petitioner
its staff intervened immediately and effectively after the staff discovered the burned
wander guard in that a nursing assistant counseled the resident. Petitioner’s post-hearing
brief at 13.

This intervention was palpably inadequate. Resident #10 is an individual who was
assessed by Petitioner’s staff as suffering from memory and judgment problems.
Petitioner’s staff concluded that the resident needed cuing and supervision to compensate
for his mental defects. In light of that, to suggest that mere “counseling” would be
sufficient to protect this resident defies common sense.

Moreover, the staff did not remove prohibited smoking materials from the resident after
they had discovered the burned wander guard. The resident continued, in violation of
Petitioner’s own policy, to possess a lighter and to smoke in his room after the point in
time when the staff allegedly counseled him. Given the staff’s failure to remove
dangerous items from the resident even the most determined counseling would be an
exercise in futility.

Petitioner’s failure adequately to supervise Resident #10’s smoking activities is, in and of
itself, sufficient to establish a failure by Petitioner to comply substantially with the
requirements of 42 C.F.R. § 483.25(h)(2). I need not consider other evidence in order to
sustain CMS’s determination of noncompliance. However, I address also CMS’s
allegations of Petitioner’s failure adequately to supervise another resident, Resident #5,
because, and as I discuss below, Petitioner’s failure to supervise this resident is as
egregious as is its failure adequately to supervise Resident #10’s smoking activities.
Moreover, CMS’s determination that Petitioner’s noncompliance began on April 26,
2006, is tied to the care that Petitioner gave to Resident #5.”

CMS’s allegations of noncompliance concerning the care that Petitioner gave to Resident
#5 center around her elopement from Petitioner’s facility on April 26, 2006, and the
aftermath of that incident. The resident was a long-term resident of Petitioner’s facility,
having resided there for about 13 years. It is undisputed that the resident suffered from

7 | find it unnecessary to address CMS’s allegations that Petitioner failed
adequately to supervise Resident #10 in order to prevent his eloping the premises of
Petitioner’s facility.
12

mental impairments and associated memory problems. P. Ex. 1, at 15.° It is also
undisputed that the resident spent much of her waking hours in a wheelchair but that she
could ambulate unassisted if necessary. Petitioner’s staff was aware that the resident was
able to walk without assistance. According to one staff member: “[Resident #5] can
walk and when she is agitated or upset she will get up and take off.” P. Ex. 1, at 20.

Petitioner’s staff identified the resident as being prone to wandering. A care plan for the
resident dated April 26, 2006 noted that the resident exhibited:

wandering with no rational purpose and is at risk for elopement due to
increased confusion.

P. Ex. 1, at 16.

Prior to April 26, 2006, the staff determined that the resident should wear a wander guard
so as to alert the staff to any attempt by the resident to leave Petitioner’s premises without
authorization. However, the resident resisted wearing a wander guard and, so, the staff’s
solution to her resistance was to attach the wander guard to the resident’s wheelchair.

The staff’s evident intent was that they would be alerted to unauthorized efforts by the
resident to leave the facility while she was in her wheelchair.

The resident was observed in her bed at about 8:00 p.m. on the 26". P. Ex. 1, at 16 - 17.
But, at about 9:00 p.m. on that evening, a dietary aide found the resident walking with the
assistance of a cane about 1/10 ofa mile up the street from Petitioner’s facility. Jd. at 18.
The staff retrieved the resident and returned her to the facility. The resident was able to
elope because she parked her wheelchair within the facility and simply walked out the
door unobserved. /d. at 17, 20. The wander guard alarm was not triggered because the
wander guard never crossed the threshold of Petitioner’s facility.

After the resident returned, the staff attempted to attach a wander guard to her person.
The resident resisted that effort strongly by attempting to strike a staff member with her
cane, and so, Petitioner’s staff abandoned the effort. See CMS Ex. 1, at 17.

CMS asserts that there is no evidence to show that Petitioner’s staff took meaningful
precautions after April 26, 2006, to ensure that the resident would not, at a future date,
elope using the same technique that she had used on the 26". Petitioner’s staff continued
to attach the wander guard to the resident’s wheelchair but not to her person. P. Ex. 1, at
19. There is no evidence that Petitioner’s staff comprehensively reviewed the events that

® Petitioner’s director of nursing characterized the resident’s mental problems as
consisting of mental retardation. P. Ex. 33, at 1.
13

occurred on the 26" for the purpose of determining whether leaving the wander guard
attached to the resident’s wheelchair provided adequate protection against her eloping
again in circumstances similar to those of the night of the 26".° Indeed, Petitioner’s
administrator was unaware of the episode prior to the June survey. Jd. Moreover, up
until the date of the survey Petitioner’s staff continued to allow the resident to sit
outdoors in front of Petitioner’s facility unsupervised except for periodic checks. Id.

The staff’s practice when the resident desired to go out was to turn off the resident’s
wander guard so that the facility’s door alarm would not be triggered when she exited the
premises.

The foregoing evidence, if unrebutted, is ample prima facie support for CMS’s assertion
that Petitioner failed to comply with the supervision requirements as concerned Resident
#5 beginning on April 26, 2006. The evidence establishes that Petitioner’s staff knew that
the resident was demented and knew that she was prone to wander when left unattended.
On April 26 the staff discovered, moreover, that their attempts to assure that the resident
did not elope were unavailing and ineffective because on that date the resident simply
walked out of Petitioner’s facility. The April 26 event put the staff on notice that more
needed to be done to protect the resident than simply to attach a wander guard to her
wheel chair. But, once the resident was returned to the facility on the 26", Petitioner’s
staff failed to augment meaningfully the surveillance and supervision that it had provided
the resident previously. The result was that the resident remained a risk for continued
elopement.

I do not find to be persuasive the several arguments that Petitioner makes in opposition to
that which was offered by CMS.

First — and as it did with respect to CMS’s allegations concerning Resident #10 —
Petitioner asserts that CMS’s allegations of noncompliance concerning the care Petitioner
gave to Resident #5 are “incomplete”, “misleading” and “unclear.” Petitioner’s post-
hearing brief at 17. These assertions notwithstanding, there is nothing that is incomplete,
misleading, or unclear about CMS’s noncompliance allegations. As I discuss above,
CMS charged explicitly that Petitioner failed adequately to monitor Resident #5 so as to
prevent her from eloping Petitioner’s facility. And, as I discuss above, CMS backed up
this explicit allegation of noncompliance with a persuasive prima facie case.

° On April 26, 2006, either shortly prior to or immediately after the elopement
incident, Petitioner’s staff amended the resident’s care plan to add several additional
interventions for Resident #5. P. Ex. 21, at 2. I discuss these in more detail, below.
Nothing in the care plan shows that the staff intensively investigated the elopement
incident or considered whether leaving the wander guard attached to the resident’s
wheelchair constituted a flaw in their surveillance of the resident.
14

The thrust of Petitioner’s defense is that during the 13-year period that Resident #5 lived
at Petitioner’s facility prior to April 26, 2006, she had never attempted to elope.
Petitioner asserts that the elopement of April 26 was, therefore, an unexpected and
unforeseeable event and Petitioner should not be held accountable for it. Petitioner’s
post-hearing brief at 18-19.

The elopement of the 26" was an unprecedented event in the narrow sense that the
resident had not attempted to elope previously. But it also was foreseeable. Indeed,
Petitioner’s staff had assessed the resident to be an elopement risk and, for that reason,
had affixed a wander guard alarm to the resident’s wheelchair.

Even if Petitioner’s staff were justifiably lulled by the resident’s long history of not
attempting to elope into believing the resident not to be a serious risk for elopement, all of
that changed on the night of the 26". Beginning with the moment that the staff
discovered the resident to be absent the staff not only was made acutely aware that the
resident was an actual elopement risk but they knew also that a// of their precautions
against elopement — especially including relying on a wander guard attached only to the
resident’s wheelchair — were unavailing. That discovery imposed on Petitioner the
obligation to reassess closely all of their previously held assumptions about Resident #5
and to determine what new or additional surveillance and supervision was necessary to
protect the resident against future elopement attempts.

Petitioner contends that it protected the resident adequately after her elopement by
promptly updating her care plan to address her wandering behaviors, with more than a
dozen interventions noted in the plan. Petitioner’s post-hearing brief at 20; P. Ex. 21, at
2. But, that care plan contains a glaring defect which should have been apparent to
anyone on Petitioner’s staff who knew the circumstances of the resident’s elopement.
The care plan does not address the flaw in Petitioner’s surveillance of Resident #5 that
enabled the resident to elope. There is literally nothing in the care plan that discusses the
possibility that the resident might defeat the wander guard attached to her wheelchair
simply by walking out of the facility.

The care plan does mention the resident’s use of a wander guard and contains precautions
for the staff to follow to assure that the wander guard functioned properly. It states that
staff would “Apply wander guard and check for placement . . . [each] shift.” P. Ex. 21, at
2. And, it states that the staff would “Check for proper functioning of wander guard each
shift.” Jd. But, placement of the wander guard on the resident’s wheelchair was known
to the staff to be an inadequate protection against elopement. Nor was a wander guard
malfunction a contributor to the resident’s April 26" elopement. That elopement would
have occurred regardless whether the wander guard functioned perfectly or was non-
functional.
15

So, although Petitioner’s staff made some efforts at better protecting Resident #5 after her
April 26, 2006 elopement, they failed to address the principal problem that enabled the
resident to elope. The resident remained vulnerable so long as that problem remained
unaddressed."

Petitioner also has not offered a satisfactory explanation for its decision to allow the
resident to continue to sit outdoors after April 26, 2006, unsupervised except for periodic
checks. Petitioner’s director of nursing testified that she did not believe that allowing the
resident to continue to sit outdoors was inappropriate, even after the resident had eloped.
P. Ex. 33, at 5. According to Petitioner: “Reasonable minds may differ regarding the
appropriateness of this professional judgment, or its efficacy, but it does not seem to be
objectively unreasonable ....” Petitioner’s post-hearing brief at 21.

I do not find this decision to be reasonable because it is not supported by the record or by
Petitioner’s logic. Petitioner asserts that the elopement of Resident #5 came as a
complete surprise to it and that its staff would have had no reason to assume the resident
to be an elopement risk given her 13-year history at the facility. But, if the April 26, 2006
elopement was a surprise and unpredictable, then how could the staff assume reasonably
that the resident would not act unpredictably at future times? By allowing the resident to
continue to sit outdoors unsupervised the staff was literally gambling that the April 26"
incident was a one-time aberration. There is nothing in the record to show that this
gamble was well-founded. For example, Petitioner’s staff could not have reasonably
decided that the resident should remain free to sit outdoors unattended based on a
professional evaluation of the resident’s mental status because the resident was not seen
by a mental health professional until June 20, 2006. P. Ex. 29.

2. Petitioner did not prove to be clearly erroneous CMS’s determination
that its noncompliance with 42 C.F.R. §§ 483.25(h)(1) and (h)(2) was at
the immediate jeopardy level.

It is Petitioner’s burden to prove clearly erroneous a determination by CMS that a
deficiency puts residents at immediate jeopardy. 42 C.F.R. § 498.60(c)(2). Petitioner
failed to meet that burden.

' Petitioner offers no explanation for its staff’s failure to consider alternatives to
leaving the wander guard attached to the resident’s wheelchair. For example, the staff
apparently gave no consideration to substituting a pressure alarm on the wheelchair seat
for the wander guard and Petitioner has not explained why such an intervention would not
have better protected Resident #5.
16

There is strong evidence in this case to support the conclusion that Petitioner’s
noncompliance with 42 C.F.R. §§ 483.25(h)(1) and (h)(2) was at the immediate jeopardy
level. The evidence showing that Petitioner’s staff failed to protect Resident #10 against
accident hazards and failed to supervise Resident #5 adequately also supports a finding
that there was considerable likelihood that residents of Petitioner’s facility were at risk of
serious injury, harm, impairment, or death. The evidence demonstrates that Petitioner’s
staff failed to comprehend their basic obligation to protect residents against known or
foreseeable adverse consequences and also failed to comprehend the probable tragic
outcomes of their failure to discharge that obligation.

In the case of Resident #10, allowing him to possess a cigarette lighter was a recipe for
catastrophe. This resident was a demented individual with memory deficits and poor
judgment. The staff had overwhelming evidence, in the form of the resident’s burned
wander guard, that this resident was a risk for starting a fire within the facility that could
have injured or killed many individuals. And yet, they allowed the resident to continue to
possess the lighter well after the burned wander guard was discovered and in violation of
Petitioner’s own smoking policy.

In the case of Resident #5, Petitioner’s staff knew that the resident was mentally limited
and had a propensity to wander. Given the resident’s mental and physical condition an
elopement by her posed grave risks for her safety. But, the staff failed to address the
obvious flaw in their surveillance system for the resident for many weeks after the
resident had made that flaw evident by eloping Petitioner’s facility.

Petitioner offered no evidence to show that the probable consequences for its residents,
resulting from its staff’s inattentiveness to their obligation to protect and supervise them,
were any less than I have stated. Petitioner asserts that there is nothing in the record to
show a causal connection between any deficiency in providing care and adverse
consequences that residents would likely sustain. I disagree. The evidence strongly
points to a likelihood of serious injury, harm, impairment or death emanating from failure
by Petitioner’s staff to discharge its obligations.

What Petitioner seems to be saying is that it is unreasonable to find immediate jeopardy
here because neither Resident #10 nor Resident #5 experienced actual harm as a result of
the staff’s deficient care. In other words, Petitioner seems to be advocating a kind of “no
harm no foul” rule in which jeopardy cannot exist unless there are actual adverse
consequences. But, the regulation defining immediate jeopardy doesn’t require there to
be an adverse consequence of deficient care in order for jeopardy to exist. The regulation
is predicated on the /ikelihood of an adverse consequence. In this case, the likelihood that
residents eventually would experience serious injury, harm, impairment or death from
Petitioner’s failure to protect and supervise them was very high.
17

3. Petitioner did not prove that it eliminated immediate jeopardy, or
attained compliance with participation requirements, at dates earlier than
those that were determined by CMS.

CMS determined that immediate jeopardy persisted at Petitioner’s facility from April 26
through June 21, 2006, and it determined that noncompliance at the non-immediate
jeopardy level persisted from June 22 through July 22, 2006. Where noncompliance is
established, as in this case, it is presumed to continue until CMS certifies that it has been
remedied. A facility has the right to challenge CMS’s determination of the date when
compliance is achieved but the burden falls on the facility to prove, by the preponderance
of the evidence, that it has attained compliance at an earlier date than that which has been
determined by CMS.

Petitioner offered no evidence that it corrected its noncompliance at any date earlier than
that which was determined by CMS. Indeed, Petitioner does not argue in its post-hearing
brief that, if it was noncompliant, its noncompliance had a shorter duration than that

which was determined by CMS. Consequently, I sustain CMS’s duration determinations.

4. The civil money penalties that CMS determined to impose are
reasonable as a matter of law.

Daily penalties for immediate jeopardy level deficiencies may range from $3,050 to
$10,000 per day. 42 C.F.R. § 488.438(a)(1)(i). Daily penalties for non-immediate
jeopardy level deficiencies may range from $50 to $3,000 per day. 42 C.F.R.

§ 488.438(a)(1)(ii). The penalties that CMS determined to impose in this case were at the
minimum amounts for immediate jeopardy and non-immediate jeopardy level
deficiencies. Therefore, they are reasonable as a matter of law.

/s/
Steven T. Kessel
Administrative Law Judge


Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Civil Remedies Division

In the Case of:
Cece J. Monemou, Date: November 8, 2007

Petitioner,

Docket No. C-07-613
Decision No. CR1685

The Inspector General.

DECISION

I sustain the determination of the Inspector General (I.G.) to exclude Petitioner, Cece
Monemou, from participating in Medicare, State Medicaid programs, or other federally
funded health care programs for a period of at least five years.

I. Background

On May 31, 2007 the I.G. notified Petitioner of his exclusion. The basis that the I.G.
stated for the exclusion was that Petitioner had been convicted of a criminal offense as is
described at section 1128(a)(2) of the Social Security Act (Act).

Petitioner requested a hearing and the case was assigned to me for a hearing and a
decision. I held a pre-hearing conference and, at that conference, assigned deadlines to
the parties for submissions of briefs and proposed exhibits. I informed the parties that I
would schedule an in-person hearing if either of them requested one, and satisfied me that
he had testimony to present at a hearing that was relevant and not cumulative.

Each party filed a proposed brief. Neither party requested that I convene an in-person
hearing. I offered the I.G. the opportunity to file a reply brief but the I.G. informed me
that he saw no need to do so.
2

The L.G. filed four proposed exhibits with his brief which he designated as I.G. Exhibit
(Ex.) 1 - LG. Ex. 4. Petitioner filed one proposed exhibit to which he did not designate
with an exhibit number. The exhibit is Petitioner’s sworn statement, dated October 19,
2007. For purposes of the record I identify it as Petitioner (P.) Ex. 1. Petitioner objected
to my receiving I.G. Ex. | - 1.G. Ex. 3 into evidence. I overrule the objections and I
receive into evidence I.G. Ex. 1 - .G. Ex. 4. I explain my rationale for overruling the
objections below, at Finding | of this decision. Additionally, I receive into evidence P.
Ex. 1.

II. Issues, findings of fact and conclusions of law
A. Issues
The issues in this case are whether:

1. Petitioner was convicted of a crime that requires his exclusion pursuant
to section 1128(a)(2) of the Act; and

2. Assuming the I.G. was required to exclude Petitioner, his five-year
exclusion is mandatory.

B. Findings of fact and conclusions of law

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 separate heading.

1. The I.G. must exclude Petitioner because he was convicted of a crime
that requires his exclusion pursuant to section 1128(a)(2) of the Act.

On December 21, 2006 in a Rhode Island State court Petitioner entered a plea of nolo
contendere to a charge of simple assault. I.G. Ex. 4, at 1. Petitioner entered his plea in
order to avoid prosecution for, and possible conviction of, a more serious crime. That
alleged crime was set forth in a criminal information that had been issued against
Petitioner charging that he had abused a resident of a group home by committing an
assault and battery against that resident. I.G. Ex. 1, at 1.

The criminal information was supported by a police narrative and a witness statement that
set forth the allegations against Petitioner. 1.G. Ex. 2; 1.G. Ex. 3. Petitioner had been
employed as a caregiver at a group home. On December 27, 2005, according to a
witness, Petitioner grabbed a group home resident by his ears, pulled him from his seat,
and walked him out of the room that the resident had been seated in by pulling on the
resident’s left ear. I.G. Ex. 2, at 1.
3

Section 1128(a)(2) of the Act mandates exclusion of any individual who was convicted of
a criminal offense relating to patient abuse in connection with the delivery ofa health
care item or service. All of the requisite elements of an 1128(a)(2) offense are established
in this case by the exhibits pertaining to the charges that were filed originally against
Petitioner and his subsequent plea of nolo contendere to a charge of simple assault." On
the strength of these exhibits, Petitioner was: engaged in delivering health care items or
services as an employee of a group home; he committed an abusive act against a patient
(a resident of the group home); and he was convicted of an offense that is based on the
original charges. On the face of these exhibits, therefore, the I.G. has proven a basis for
exclusion pursuant to section 1128(a)(2).

Petitioner argues, however, that the exhibits relating to the original charges filed against
him, I.G. Ex. 1 - 1.G. Ex. 3, are irrelevant to the issue of whether he was convicted of an
128(a)(2) offense. According to Petitioner, the authority to exclude — if there is such
authority — would derive solely from his conviction. And, here, he asserts, 1.G. Ex. 4
proves only that his conviction was of a simple assault against an unnamed person under
unknown circumstances. Petitioner asserts that one may not look behind that conviction
for simple assault to decide the underlying circumstances on which the conviction is
sed for the reason that the plea that he entered is silent as to those circumstances.

disagree with Petitioner’s analysis. His argument avoids the obvious connection
etween the crime of which he was charged and the reduced crime to which he pled. The
crime of simple assault to which he pled was not conjured from thin air. Rather, it was
based on the facts that underlay the charges filed against him originally. The crime to
which Petitioner pled nolo contendere may have been a reduced offense but it was
supported by the identical facts which supported the original charges that had been filed
against him. It is well-established that, in determining the elements of a crime for
purposes of deciding whether authority exists to exclude, one may look at the facts that
form the basis for the charges that are filed against the excluded party. The often opaque
language of a plea agreement or a judgment of conviction will be no impediment to
finding authority to exclude where the agreement or judgment is clearly supported by
other official records that lay out the elements of the crime.

It might be different had Petitioner been convicted of a crime that was, on its face, totally
unrelated to the allegations made in the original criminal information. In that
circumstance it would not be possible to find a nexus between what was charged and the
crime to which Petitioner pled. But here, the nexus is patent.

“ Section 1128(i)(3) of the Act defines a conviction to include a plea of nolo
contendere that is accepted by a court. Petitioner’s plea of nolo contendere therefore has
the same consequences under section 1128 as would a conviction after a trial.
4

Petitioner offered P. Ex. 1, which consists of his sworn statement in which he essentially
denies that he assaulted the resident, as apparent proof that he was not actually guilty of
an assault. He contends, evidently, that he should be allowed to offer this evidence to
rebut I.G. Ex. 1 - I.G. Ex. 3, on the theory that if I am inclined to “look behind” his
conviction for simple assault then, I should also accept his denial that he perpetrated an
assault.

The authority to exclude in this case derives from Petitioner’s conviction. The conviction
—and those official records relating to it — define the basis for the exclusion. It is not
permissible in a case such as this one to relitigate the facts underlying the conviction in
order to decide whether the excluded individual, in fact, committed the offense for which
he or she was convicted.

My reliance on the official records pertaining to the information filed against Petitioner
and his subsequent nolo contendere plea to a reduced but related offense is in no sense a
relitigation of the facts of his case. The I.G.’s exhibits consist solely of the official record
of Petitioner’s criminal case and I have accepted them only to decide what Petitioner was
charged with, what he ultimately pled to, and the facts that underlay his conviction. By
contrast, P. Ex. 1 is a document that is outside of the official record of Petitioner’s
conviction and is, therefore, not relevant to the issue of what he was charged with and
pled to. Consequently, the assertions now made by Petitioner in P. Ex. 1 are no basis for
me to find the I.G. to be without authority to exclude him.

2. Petitioner’s five-year exclusion is mandatory.

An exclusion of at least five years is mandatory for an individual who has been convicted
of an offense that is described at section 1128(a)(2) of the Act. Act, § 1128(c)(3)(B).
Petitioner’s exclusion is reasonable as a matter of law inasmuch as he was excluded for
the minimum mandatory period.

/s/
Steven T. Kessel
Administrative Law Judge


Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Civil Remedies Division

In the Case of: )
)
Sunset Villa Care Center, ) Date: November 2, 2007

(CCN: 32-5117), )
)
Petitioner, )
)

-V.- ) Docket No. C-07-435

) Decision No. CR1683
Centers for Medicare & Medicaid )
Services. )
a )

DECISION

dismiss the hearing request of Petitioner, Sunset Villa Care Center, because it has no
right to a hearing.

I. Background

Petitioner is a skilled nursing facility located in Roswell, New Mexico. It participates in
the Medicare program. Its participation in Medicare is governed by sections 1866 and
819 of the Social Security Act and by implementing regulations at 42 C.F.R. Parts 483
and 488. Also, its right to a hearing in this case is governed by regulations at 42 C.F.R.
Part 498.

On March 28, 2007 (March survey), Petitioner was surveyed for compliance with
Medicare participation requirements. Based on the results of that survey the Centers for
Medicare & Medicaid Services (CMS) determined that Petitioner no longer met
participation requirements. It determined to impose remedies against Petitioner
consisting of the termination of Petitioner’s provider agreement, and a denial of payment
for new admissions. CMS Exhibit (Ex.) 1.
2

Petitioner requested a hearing to challenge the deficiency findings that were made at the
March survey and CMS’s remedy determinations, and the case was assigned to me for a
hearing and a decision.

However, in subsequent correspondence dated September 28, 2007, CMS notified
Petitioner that it was rescinding the termination of Petitioner’s provider agreement and
the denial of payment for new admissions that it had determined to impose to remedy
deficiencies identified at the March survey. CMS Ex. 2. As a consequence, CMS is no
longer demanding that any remedies be imposed against Petitioner.

On October 3, 2007, CMS moved to dismiss Petitioner’s hearing request. CMS submitted
two (2) exhibits with its motion. Petitioner did not object to the exhibits nor did
Petitioner object to the motion to dismiss.

In the absence of objection, I admit CMS Exs. 1-2 into the record.
II. Discussion

The hearing rights of a long-term care facility are established by federal regulations at 42
C.F.R. Part 498. A provider dissatisfied with CMS’s initial determination is entitled to
further review, but administrative actions that are not initial determinations are not
subject to appeal. 42 C.F.R. § 498.3(d). The regulations specify which actions are
“initial determinations” and set forth examples of actions that are not. A finding of
noncompliance that results in the imposition of a remedy specified in 42 C.F.R. § 488.406
is an initial determination for which a facility may request a hearing before an
administrative law judge. 42 C.F.R. § 498.3(b)(13). Unless the finding of
noncompliance results in the imposition of a specified remedy, the finding is not an initial
determination. 42 C.F.R. § 498.3(d)(10)(ii).

In the matter before me, CMS has rescinded it remedy determination, therefore, Petitioner
no longer has a right to hearing because the determination that is subject to a hearing no
longer exists. Schowalter Villa, DAB No. 1688 (1999); Arcadia Acres, DAB No. 1607
(1997); Rafael Convalescent Hospital, DAB No. 1616 (1997).
Ill. Conclusion

I must dismiss a hearing request where the requesting party has no legal right to a
hearing. 42 C.F.R. § 498.70(b). Petitioner no longer has a right to a hearing in this case
because the unchallenged facts are that CMS rescinded its remedy determination.
Consequently, I dismiss Petitioner’s hearing request.

/s/
Alfonso J. Montafio
Administrative Law Judge


Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

In the Case of: )
)
The Laurels at Forest Glenn, ) Date: October 30, 2007

)
Petitioner, )
)

-Vv.- ) Docket No. C-06-666

) Decision No. CR1681
Centers for Medicare & Medicaid )
Services. )
)

DECISION

The Laurels at Forest Glenn (Petitioner or facility) is a skilled nursing facility, located in
Garner, North Carolina, that participates in the Medicare program. On June 27 and 28,
2006, the North Carolina Department of Health and Human Services (State Agency)
investigated a complaint about the facility’s response to a diabetic resident’s extreme
hypoglycemic episode. Based on the results of that investigation, the Centers for
Medicare and Medicaid Services (CMS) determined that, from June 22 through August 8,
2006, the facility was not in substantial compliance with two Medicare requirements, 42
C.F.R. § 483.10(b)(11) (notification of change) and 42 C.F.R. § 483.25 (quality of care).
CMS also determined that, from June 22 through 27, 2006, the facility’s deficiencies
posed immediate jeopardy to resident health and safety. CMS imposes a civil money
penalty (CMP) of $3050 per day for each day of immediate jeopardy, and $50 per day for
each day of substantial noncompliance that was not immediate jeopardy. Petitioner
appeals.

For the reasons set forth below, I sustain CMS’s determinations.
I. Background
The Social Security Act (Act) sets forth requirements for nursing facility participation in

the Medicare program, and authorizes the Secretary of Health and Human Services to
promulgate regulations implementing the statutory provisions. Act, § 1819. The
2

Secretary’s regulations are found at 42 C.F.R. Part 483. To participate in the Medicare
program, a nursing facility must maintain substantial compliance with program
requirements. To be in substantial compliance, a facility’s deficiencies may pose no
greater risk to resident health and safety than “the potential for causing minimal harm.”
42 C.F.R. § 488.301.

The Secretary contracts with state survey agencies to conduct periodic surveys to
determine whether skilled nursing facilities are in substantial compliance with program
participation requirements. Act, § 1864(a); 42 C.F.R. § 488.20. The regulations require
that each facility be surveyed once every twelve months, and more often, if necessary, to
ensure that identified deficiencies are corrected. Act § 1819(g)(2)(A); 42 C.F.R.

§§ 488.20(a); 488.308.

In this case, following the June 27-28 complaint investigation/survey, the State Agency’s
surveyors concluded that the facility was not in substantial compliance with federal
requirements for nursing homes participating in the Medicare and Medicaid programs,
and that its deficiencies posed immediate jeopardy to resident health and safety.
Specifically, they found that the facility did not meet federal requirements under: 42
C.F.R. § 483.10(b)(11) (Tag F-157 - Notification of Changes) and 42 C.F.R. § 483.25
(Tag F-309 - Quality of Care). Petitioner’s Exhibit (P. Ex.) 1; CMS Exhibits (CMS Exs.)
2,10, 18.'

CMS has agreed with the State Agency’s recommendations and imposes a CMP of $3050
per day for each day of immediate jeopardy, June 22-27, 2006 ($3050 x 6 days =
$18,300), plus $50 per day for the period of noncompliance that did not pose immediate
jeopardy, June 28—August 8, 2006 ($50 x 42 days = $2100) (total CMP = $20,400). CMS
Ex. 5, at 2; CMS Ex. 8, at 2; Transcript (Tr.) at 8.

' The State Agency subsequently affirmed these findings following an informal
dispute resolution proceeding. CMS Ex. 4.

> From the documents submitted, I could not initially determine which dates of
alleged noncompliance were in controversy. At the opening of the hearing, I asked the
parties to identify the period in dispute, which, remarkably, neither counsel seemed
prepared to do. (“That’s a good question, Judge. I haven’t actually focused on that.”’)
After some discussion, and input from an employee of the State Agency, the parties
agreed that June 22 through August 8 were the relevant dates. Tr. at 1-8. Based on an
August 9 survey, additional penalties were apparently imposed for the period August 9
through September 22, 2006 (CMS Ex. 5), but Petitioner has not appealed that survey:

(continued...)
3

Petitioner timely requested a hearing, and the case was assigned to me. The hearing
convened on June 6, 2007, in Raleigh, North Carolina. Mr. Joseph L. Bianculli appeared
on behalf of Petitioner, and Ms. Sonia G. Burnett appeared on behalf of CMS. I have
admitted into evidence CMS Exs. 1-18 and P. Exs. 1-41.

The parties filed initial (opening) briefs and submissions. Following the hearing, they
filed closing briefs (CMS Cl. Br and P. Cl. Br.). Petitioner filed a reply brief.

*(...continued)
MS. BURNETT: [T]hat [August 9] revisit is not at issue in this case.

JUDGE HUGHES: Because it was not appealed or because —
MS. BURNETT: __ It was not appealed.

JUDGE HUGHES: It was not appealed. So, then, I’m only concerned
about the period from June 22" through August 8"?

MR. BIANCULLI: That is correct.

Tr. at 7-8. Yet, in their briefs, the parties seem to have forgotten this explicit
representation and agreement; each refers, without explanation, to penalties imposed
through September 22, 2006. P. Cl. Br. at 6; CMS Cl. Br. at 3. Inasmuch as I have
before me no hearing request for the August 9, 2006 revisit survey, I consider only the
facility’s compliance through August 8.

> Petitioner objected to admission of CMS Ex. 17, which is a policy issuance from
the American Medical Directors Association (AMDA). CMS objected to P. Ex. 28,
which is the same policy issuance from the AMDA. CMS also objected to the admission
of P. Ex. 30, which are guidelines from the American Diabetes Association, even though
CMS included these same guidelines in its own exhibits, CMS Ex. 13, at 13, 14. The
parties were not able to explain why they objected to the admission of documents that
they had included among their own exhibits. Inasmuch as neither party had a legitimate
objection, I admitted all of the documents. Order and Setting of Hearing Date (April 18,
2007).

II. Issues
The issues before me are:

. Whether, from June 22 through August 8, 2006, the facility was in substantial
compliance with 42 C.F.R. §§ 483.10(b)(11) (notification of changes); and 483.25
(quality of care);

. If the facility was not in substantial compliance from June 22 through 27, 2006,
did its deficiencies then pose immediate jeopardy to resident health and safety?

Tr. at 8. I do not consider whether the amount of the CMP is reasonable. CMS has
imposed the statutory and regulatory minimum per day amounts so the penalty is
reasonable as a matter of law. See, e.g., Hermina Traeye Memorial Nursing Home, DAB
No. 1810, at 16 (2002).

III. Discussion

A, From June 22 through August 8, 2006, the facility was not
in substantial compliance with 42 C.F.R. § 483.10(b)(11)
nor with 42 C.F.R. § 483.25.

Under the statute and the “quality of care” regulation, each resident must receive, and the
facility must provide, the necessary care and services to allow a resident to attain or
maintain the highest practicable physical, mental, and psychosocial well-being, in
accordance with the resident’s comprehensive assessment and plan of care. Act,

§ 1819(b); 42 C.F.R. § 483.25.

The regulations also require that the facility consult the attending physician immediately
whenever there is a significant change in a resident’s status or whenever there is a need to
alter treatment significantly, i.e., “a need to discontinue an existing form of treatment due
to adverse consequences, or to commence a new form of treatment.” 42 C.F.R.

§ 483.10(b)(11); Georgian Court Nursing Center, DAB No. 1866, at 18-19 (2003).

4 My findings of fact and conclusions of law are set forth, in italics and bold, in
the discussion captions of this decision.
5

This case centers around the facility’s treatment of one of its residents. Resident 1 (R1)
was a 73-year-old man who fell at his home, fracturing his cervical spine and his right
arm. He also had diagnoses of Type 2 (non-insulin dependent) diabetes, chronic renal
insufficiency, hypertension, and coronary artery disease. Among his medications, R1
took the oral medications, Avandia and Amaryl, for his diabetes. P. Exs. 7, 11, 21.

R1 was hospitalized following his accident, and, during his hospitalization, he
experienced episodes of hypoglycemia (abnormally low blood sugar). At the time of his
discharge from the hospital, his hospital physician characterized his condition as “good,”
ut, because of his recurring hypoglycemia, recommended that his blood sugar be
monitored. P. Exs. 4, 7; Tr. at 18-19. The facility’s Director of Nursing (DON), Linda
Wood, acknowledges the hospital’s advice “that the nursing facility should monitor him
to be aware of ‘serious’ hypoglycemia.” P. Ex. 39, at 2 (Wood Decl.).

mmediately following his hospitalization, R1 was admitted to the facility on June 19,
2006. Assessments made at the time of his admission describe R1 as alert but confused.
His speech was clear and his memory intact, although he was depressed and angry. P. Ex.
4, at 1. He wore a cervical collar. P. Ex. 40, at 2; Tr. at 33. According to the facility’s
progress notes, on the night of his admission, R1 was alert, verbal, and able to answer
questions appropriately, although he became increasingly agitated when not allowed to
get out of bed. Staff gave him Percocet.’ P. Ex. 21, at 1.

According to one of the facility’s assessments, which has a reference date of June 21,
2006, R1’s memory was “ok.” He could recall the location of his room, and the names
and faces of staff. He knew that he was in a nursing home. He had no problems with
altered perception or awareness, and no episodes of disorganized speech. He had periods
of restlessness, and his mental functions varied over the course of the day. He could
make himself understood, and was usually able to understand others. In contrast to his
earlier assessment, this one says that he displayed few indicators of depression, anxiety or
sadness — the only block marked indicates that, within the preceding five days, he had
exhibited “sad, pained, worried facial expressions.” Further, these indicators
(sad/pained/worried expressions) were easily altered, according to the assessment. P. Ex.
26, at 2. He exhibited no behavioral symptoms. He experienced pain, sometimes
excruciating pain, daily. P. Ex. 26, at 3-4.

> R1 was prescribed Percocet for pain. P. Ex. 24, at 4; see also P. Ex. 34. As the
state surveyor Patrick Campbell pointed out, the note suggests no complaints of pain, but
he got two Percocet anyway. Tr. at 40; P. Ex. 21, at 1. Percocet is not an appropriate
treatment for agitation. Tr. at 41; P. Ex. 34; see also P. Ex. 21, at 3 (Resident very
agitated. PRN Percocet given).
6

Consistent with the June 21 assessment, the facility’s rehabilitation manager told
Surveyor Campbell that, when R1 participated in physical therapy on June 20 and 21, his
speech was clear and he was responsive; he even joked around with her. Tr. at 61.

1. Facility staff inadequately monitored R1’s
blood sugar levels.°

The facility and Petitioner’s physician, Dr. Bernard Bennett (who was also the facility’s
medical director), seem to have given short shrift to consideration of R1’s diabetes. His
admission care plan includes no instructions for managing diabetes, even though the
plan’s format contains a discrete section titled “Diabetes.” The form contains a specific
place to fill in how often blood sugar should be checked, but that line (and indeed the
entire section) is left blank. P. Ex. 17, at 2. Similarly, Dr. Bennett provided no specific
guidance for monitoring R1’s blood sugar level or for responding if those levels were
abnormal. Indeed, although Dr. Bennett examined R1 on June 21, 2006, his report does
not mention diabetes. He simply describes R1 as sitting in a chair in no apparent distress,
and characterizes the resident as “stable” with no neurologic deficit. P. Ex. 22.’

otwithstanding the absence of a written diabetes assessment or physician order for
monitoring his blood sugar, R1’s medication administration record (MAR) indicates that
blood sugar checks should be performed a minimum of four times per day: at 7:30 a.m;
11:30 a.m; 4:30 p.m.; and 9:00 p.m. But no finger stick tests were recorded for the day of
R1’s admission, June 19. Nor were levels recorded at 7:30 a.m. on June 20. The first
blood level recorded following R1’s admission was taken at 11:30 a.m. on June 20. P.
Ex. 24, at 3; P. Ex. 1, at 16; CMS Ex. 2, at 16; Tr. at 72. So, even though R1’s hospital
physician had pointed out the need for careful monitoring, and the facility knew that he
had “serious hypoglycemia,” it did not even begin to test blood levels until late morning

° T address below Petitioner’s argument that the facility may not here be held
accountable for this and other deficiencies.

7 Dr. Bennett apparently refused to testify in this matter. I am frankly skeptical (as
was Petitioner) of Dr. Bennet’s claim that state law precluded him from discussing the
matter with the nursing facility of which he was the medical director. Petitioner asked
that I issue a deposition subpoena so that counsel could depose Dr. Bennett in advance of
the hearing and submit his deposition testimony, but the regulations do not grant me the
authority to issue such a subpoena. Although Petitioner suggested that Dr. Bennett might
be subpoened to testify at the hearing, it neither asked me to issue a subpoena for the
hearing, nor otherwise satisfied the regulatory requirements for its issuance. 42 C.F.R.

§ 498.58.
7

on his second day there.* Nor did the facility test R1’s blood sugar level at 11:30 a.m. on
June 22, 2006. Had staff done so, they would have found that it was dangerously low.
See discussion infra.

2. Facility staff did not follow the facility’s protocol for
notifying the physician of R1’s low blood sugar levels.

The parties dispute whether the facility provided its staff guidance for notifying an
attending physician of a resident’s abnormal blood sugar levels. CMS points out that
R1’s medical record includes no instructions for calling his physician in the event of an
abnormal blood sugar reading. Another facility document, titled “Observations to Report
to the Physician” does not mention blood sugar levels, although it instructs staff to “report
changes . .. to the physician as soon as possible, but no later than one hour after the
observation of a significant or life threatening change in condition, and four hours for an
observed change in condition.” CMS Ex. 17, at 10.

Petitioner claims that specific instructions for monitoring or responding were unnecessary
since Dr. Bennett had in place for all of his diabetic residents a standing order for the
administration of insulin should blood sugar levels exceed certain parameters. P. Ex. 38;
P. Ex. 41, at 2 (Bishop Decl.). A copy of this order was placed in R1’s chart. But this
order does not resolve CMS’s objections because it addresses episodes of hyperglycemia
only; it says nothing about hypoglycemia, and, in any event, says absolutely nothing
about notifying the physician of any abnormalities. P. Ex. 38; see CMS Ex. 18, at 1
(Campbell Decl. § 4); Tr. at 42, 47-48.

Petitioner also produces a document that was not in R1’s chart, but which Petitioner
characterizes as its protocol for treating hypoglycemia. The document includes
parameters for consulting a physician about abnormally low blood sugar levels. P. Ex.
29. The document includes a description of the “usual symptoms” of mild, moderate, and
severe hypoglycemia, and the accompanying blood sugar levels. It instructs specific
treatments for each level. For mild hypoglycemia (blood sugar levels of 50-70 mg/dl),
staff should give the resident 10-15 grams of a simple carbohydrate (e.g., 4 ounces of

® Petitioner argues, without much support, that R1 had a “pattern” of low blood
sugar in the morning. P. Cl. Br. at 10. If this were so, and staff knew it, its failure to
measure his 7:30 a.m. blood level would have been all the more indefensible.
8

orange or apple juice). For moderate hypoglycemia (blood sugar levels of less than 50
mg/dl), staff are instructed to administer 20 grams of a simple carbohydrate (e.g., 6
ounces of orange or apple juice). For severe hypoglycemia (usually 20 mg/dl or less),
staff are to administer Glucagon’ intramuscularly or subcutaneously. P. Ex. 29.

Fifteen minutes after administering the treatment, staff are instructed to re-test for blood
sugar levels. If the resident’s blood sugar level has not risen above 70 mg/dl, staff are to
re-administer the prescribed treatment, and to re-test after an additional fifteen minutes.
“If glucose has not risen to 70 mg/dl, call the physician immediately.” (Emphasis in
original) P. Ex. 29.

According to Surveyor Campbell, he specifically asked but found no staff member who
even knew where to find this protocol. Tr. at 50. This seems likely inasmuch as the
protocol was not followed. See discussion infra. Moreover, according to Lori Bishop,
R.N., who was the Unit Manager for R1’s unit, staff were only required to contact the
physician “immediately” in a life-threatening situation, a position that seems at odds with
this protocol (unless the facility considers life-threatening prolonged episodes of
hypoglycemia) and the position articulated by DON Wood. Tr. at 143.

DON Wood stated in her written declaration that

Our policies and procedures . . . provide typical protocols .. . for
responding to low blood sugar, including providing sugary foods,
remeasuring blood sugar, and, where the blood sugar level does not rise
within a certain time, to call the physician.

P. Ex. 39, at 3 (Wood Decl.) When questioned about the policy for notifying the doctor,
DON Wood replied that staff would normally notify the doctor if blood levels were “out
of the limit.” She defined “out of the limit” as “typically ... somewhere around 70 or
below.” Tr. at 97-98.

° Glucagon is a medication that increases blood glucose.
9

But staff did not call the physician, even when blood sugar levels fell — and remained —
well below 70.'° At 7:30 a.m. on June 21, R1’s blood sugar was 48. The facility had no
orange juice, but gave him a can of Ensure. When re-tested half an hour later, his blood
sugar was still 48.'' Nobody called the physician. P. Ex. 32;’? P. Ex. 1, at 17; Tr. at 98-
00.

Not one shred of evidence suggests that any staff ever notified the physician of these
lood sugar levels. Nevertheless, Petitioner characterizes the documentation as simply
“not clear,” and says that Dr. Bennett probably knew about the blood levels when he
visited later in the day, but he considered the matter too insignificant to warrant any
mention. P. Cl. Br. at 13-14. I note first that the facility’s protocol, by itself, establishes
that the facility had determined that a blood sugar reading below 70 — that stays below 70
alf an hour after treatment — is very significant and requires immediate physician
involvement. Moreover, no facility witness has claimed that the physician was ever
notified; no document suggests that the physician was notified; and Dr. Bennett’s June
21, 2006 note does not even mention R1’s diabetes, much less his episodes of
ypoglycemia.

n any event, even if staff had advised Dr. Bennett some time later, the protocol directed
them to notify him “immediately” when the 8:00 a.m. blood level came in so low, but
they failed to follow that protocol.

© According to R1’s MAR, his 4:30 p.m. readings on June 20 and 21 showed mild
hypoglycemia (63 and 62 respectively). According to both the written protocol and DON
Wood’s testimony, the physician should have been consulted. I find no evidence in the
nurses notes or elsewhere that staff offered the protocol-prescribed treatment, retested, or
contacted the physician. See P. Ex. 21, at 2, 3 (no mention of blood levels in nurses
notes).

'' DON Wood incorrectly states that R1’s blood sugar “came right up” after he ate
breakfast and a carbohydrate-rich supplement. P. Ex. 39, at 4. Petitioner’s records
establish that it remained at the same low level, even after he took the supplement.

Petitioner presents a typed statement, signed by Wanda Seymour, describing
these events. Although it says on its face that it was written on June 28, 2006, Ms.
Seymour’s signature is dated July 27, 2006. P. Ex. 32. An undated, hand-written version
of this statement can be found at CMS Ex. 13, at 86.
10

Because staff did not consult the attending physician when, according to the facility’s
own protocol, such consultation was necessary, the facility was not in substantial
compliance with 42 C.F.R. § 483.10(b)(11), and it was not providing R1 necessary care
and services, in violation of 42 C.F.R. § 483.25.

3. Facility staff delayed for hours notifying the attending
physician of a significant change in R1’s condition.

On the morning of June 22, 2006, R1’s condition changed. According to his MAR, his
7:30 a.m. blood sugar level was 93, which is within normal range. However, by 8:00
a.m., according to a nurses note, his speech was slurred and the nurse had “difficulty
understanding some of his conversation.” His pupils were 3 cm and sluggishly reactive to
light; on the other hand, he displayed no seizure activity, and denied pain or discomfort.
P. Ex. 21, at 4. At 8:30, according to the note, he complained of thirst. He took water,
with coughing. Staff attempted to feed him breakfast, but he coughed as he took sips of
fluid and small bites of food. He was unable to eat, drink, or take his medication, and was
hyper-extending his neck. P. Ex. 21, at 4; Tr. at 86.

Staff did not contact his physician nor re-test his blood sugar.

When his wife came to the facility at about 11:00 a.m., she was extremely upset by his
appearance. He was gurgling; his head was back; his eyes were glassy; “he looked like
he’d had a stroke.” P. Ex. 21, at 4; P. Ex. 41, at 2-3 (Bishop Decl.). She insisted that the
facility call 911.

[H]is wife was next to him extremely distraught, crying, very,
very excited, saying that there was something wrong with her
husband. He appeared to be shaking. He was having trouble
getting speech out.

Tr. at 132-133.

Shortly before noon, Unit Manager Bishop decided to call for an ambulance.
Fortuitously, a team of paramedics arrived at the facility at about the same time.
According to their report, they were there to pick up another resident, but that individual
had already been taken to the hospital. A staff member (presumably Unit Manager
Bishop) said to them “but we have another one you may as well take since you are here.”
CMS Ex. 13, at 69; P. Ex. 41, at 2-3.
11

At 11:56 a.m., the paramedics found R1 in a wheelchair with “snoring respiration,” and
“unresponsive to physical stimuli.” CMS Ex. 13, at 46, 66, 69; Tr. at 67-68. They
immediately assessed him and noted “hypoglycemia” on their event chronology report.
Though dry, his skin was “pale/ashen.” They took his blood glucose level at 12:01 p.m.
and it registered 20 mg/dl. Within minutes, the paramedics began administering
intravenous dextrose. R1 then became responsive and “‘back to baseline’ per staff.”
CMS. Ex. 13, at 46, 66. However, he became sleepy again, so they administered more
dextrose. The paramedics took him to the emergency room, and he was subsequently
admitted to the hospital. CMS. Ex. 13, at 46-50; P. Ex. 21, at 4. His hospital physicians
took him off his oral hypoglycemic medications. CMS Ex. 13, at 51.

In response to this compelling evidence, Petitioner argues that it was not required to
consult with R1’s physician because R1’s condition did not change significantly on the
morning of June 22. Moreover, according to Petitioner, even if R1’s condition changed
significantly, staff had no reason to suspect low blood sugar; they reasonably attributed
R1’s changed demeanor to pain medication and/or another cause, and, before consulting
the physician, they decided to monitor his changes.

I reject Petitioner’s argument that R1 did not undergo a significant change within the
meaning of 42 C.F.R. § 483.10(b)(11). Nor am I persuaded that the facility was not
required to consult the physician because staff did not suspect hypoglycemia, but
attributed R1’s changed demeanor to some other cause, such as his pain medication
and/or restless night. The regulation requires that the facility consult the physician when
there is a significant change, regardless of its cause.'*

Unit Manager Bishop claims that it was not necessary to contact R1’s physician because
nothing life-threatening was going on. Tr. at 143. But this is not the regulatory standard.
“Significant” does not mean “life-threatening.” Nor does the regulation require a medical
emergency. The regulation mandates consultation with the resident’s physician when
there is —

(B) A significant change in the resident’s physical, mental, or
psychosocial status (i.e., a deterioration in health, mental, or
psychosocial status in either life-threatening conditions or
clinical complications); [or]

'S Where a medication causes these types of adverse consequences — inability to
eat, drink, or swallow, altered mentation, unintelligible speech — the physician must be
consulted so that he/she can consider treatment changes.
12

(C) A need to alter treatment significantly (i.e., a need to
discontinue an existing form of treatment due to adverse
consequences, or to commence a new form of treatment).

42 C.F.R. § 483.10(b)(11). Drafters of the regulation emphasized that “in all cases,
whether or not there is a medical emergency,” the facility must immediately consult the
attending physician. 56 Fed. Reg. 48826, 48833 (September 26, 1991). As the drafters
explained, a “significant change” could be life-threatening, but it could also involve
clinical complications, such as the development of a stage II pressure sore or onset of
delirium.

The changes to R1 fall well within the regulatory definition. In fact, as all parties now
agree, the change in Petitioner’s condition was potentially life-threatening, and it resulted
in his hospital physicians significantly altering his treatment; not only did he require
multiple ampules of dextrose, he was also permanently taken off his oral hypoglycemic
medications. CMS Ex. 13, at 55.

Moreover, even assuming that facility staff could not reasonably have suspected that R1
was suffering from hypoglycemia (which I find highly questionable), they should have
recognized the need to consult his physician. Petitioner acknowledges that, on the
morning of June 22, R1 did not “look good” and that his speech was difficult to
understand, but claims that these were not significant departures from his usual
appearance. According to Petitioner, R1 had not looked good from the time of his
admission, because his face was bruised, and his speech was always difficult to
understand, because of his cervical collar.

R1’s face was bruised, but his assessments establish that, until the morning of June 22nd,
his speech was clear and understandable, and his memory was intact. P. Ex. 14; P. Ex.
21, at 1; P. Ex. 26. He was able to eat, drink, swallow, and take his medications without
difficulty. P. Ex. 33. The facility’s rehabilitation manager, who had worked with R1 on
the 20th and 21st, described him as a joker. When she heard the administrator refer to
him as non-verbal, she said that “you got to be looking at the wrong guy[;] he’s fine... .”
Tr. at 61.
13

On June 22, staff recognized that R1 had undergone a significant change. They told the
paramedics, that R1 was found “with altered mentation this a.m.[;] originally responding
to voice with garbled, unintelligible responses, now unresponsive to voice.” CMS Ex. 13,
at 69.'4

Petitioner acknowledges, as it must, that R1’s wife noticed immediately that something
was terribly wrong with her husband, but suggests that only someone close to him would
ave seen the changes. I disagree. These were not subtle changes, detectable only to one
who was intimately familiar with R1. The changes she saw in her husband were so
dramatic and disturbing, that, as Unit Manager Bishop testified, she panicked when she
saw him. Tr. at 132-133.

Petitioner’s witness, Karen Becton, R.N., testified that when she saw R1, shortly after
7:00 a.m. on June 22, he appeared “more restless and uncomfortable” than he had two
days earlier (when she had last seen him). P. Ex. 40, at 2. He was agitated; he was
yper-extending his neck; and his speech was slurred, “obvious” symptoms of stroke,
according to Nurse Becton. P. Ex. 40, at 3. Moreover, he had previously been able to eat
and drink without any apparent difficulty, but, on the morning of the 22nd, he could not
even swallow. See P. Ex. 33 (on the mornings of June 21 and 22, R1 ate breakfast and
drank); Tr. at 85 (“he would go coughing and gagging as though he was having difficulty.
That was a change... .”).

Nurse Becton first testified that she did not consider these significant changes because
R1’s vital signs were normal, “and he was alert.” Tr. at 85-86. But then she said that
slurred speech, gagging, and inability to consume water or take medication were
significant changes. Tr. at 85-87. Then, on re-direct, she said that “when I think of the
whole picture, he remained alert, the vitals did not show a change,” so she decided not to
consult the physician, but to continue monitoring him. Tr. at 87-88. (Unfortunately, her
“monitoring” did not include checking his blood sugar levels.)

Thus, Nurse Becton appears to agree that R1’s condition changed, but claims that the
changes were not significant because he was “alert.” Sometime after 8:30 a.m., however,
he was no longer alert. But Nurse Becton still did not consult his physician, because she
thought he might have been sedated by the Percocet. Tr. at 87, 89.

‘* According to the paramedics’ prehospital report, R1’s history of non-insulin
dependent diabetes was “not disclosed by staff.” CMS Ex. 13, at 69.
14

Nurse Becton claims that she was not concerned about R1’s blood sugar because his 7:30
a.m. reading was 93, “higher than the previous two mornings.” P. Ex. 40, at 3 (Becton
Decl.). DON Wood makes a similar claim: that his “normal pattern was to have low

lood sugar in the early morning,” and that “this same pattern repeated during the early
morning hours of both June 20 and June 21.” P. Ex. 39, at 3 (Becton Decl.). But, as
discussed above, there were no early morning blood levels recorded on June 20. No level
was taken until 11:30 a.m. P. Ex. 24, at 3; P. Ex. 1, at 16. So staff could not reasonably
ave relied on any such June 20 reading.

And Petitioner is incorrect in asserting that R1 displayed no symptoms of hypoglycemia.
He did not display all of the symptoms listed in the facility’s protocol, but he displayed
many of them: shakiness, anxiety and irritability (symptoms of mild hypoglycemia);
sleepiness, lack of coordination, altered behavior (symptoms of moderate hypoglycemia);
and inability to take by mouth (symptom of severe hypoglycemia). P. Ex. 29; Tr. at 64-
67. Moreover, staff should also have recognized that some people have no symptoms of
ypoglycemia, and may lose consciousness without ever knowing that their blood sugar
levels are dropping. P. Ex. 30, at 1. I note also that when the paramedics observed R1,
they immediately suspected hypoglycemia, and, within minutes, were testing his blood
sugar. CMS Ex. 13, at 70 (“11:56 paramedic assessment... hypoglycemia... 12:01
Blood Glucose . . . mg/dl 20.”).

n this case, the facility twice failed to consult R1’s attending physician about a
significant change in his condition, and it was therefore not in compliance with 42 C.F.R.
§ 483.10(b)(11). Because the facility’s inaction also meant that it was not providing R1
necessary care and services, its failure to notify puts it out of compliance with the quality
of care regulation, 42 C.F.R. § 483.25, as well. The facility also failed to provide R1
“necessary care and services” for treatment of his diabetes “in accordance with [his]
comprehensive assessment and plan of care.” As the evidence shows, the facility did not
assess his diabetes. Though aware if his “serious hypoglycemia,” the facility skipped all
of his blood sugar tests for the day of his admission and the first test of the following day.
It did not test his blood sugar as called for in his MAR even when he was displaying
significant symptoms of hypoglycemia. Independent of the facility’s failure to consult the
attending physician, these failures establish the facility’s noncompliance with quality of
care requirements."

'S Petitioner dismisses the “quality of care” regulation as “catchall,” suggesting
that the only important finding here was failure to notify. P. Cl. Br. at 7, 25. I disagree.
While a facility that fails to comply with the quality of care requirements often has
deficiencies under other regulations, that hardly negates the significance of quality of care

(continued...)
15

B. In determining whether the facility was in substantial
compliance with the quality of care and notification of
changes regulations, I may consider all relevant evidence,
including evidence of R1’s treatment prior to the morning of
June 22, 2006.

Petitioner offers a perplexing argument about the nature of de novo review, culminating
in the assertion that

CMS plainly based its action on the conclusion that
Petitioner’s staff did not appropriately identify and respond to
[R1’s] developing (Aypoglycemic) illness during the morning
in question — not that the Resident’s attending physician’s
“standing orders” for sliding scale insulin (for hyperglycemia)
were not sufficiently individualized; or that a nurse failed to
do a blood sugar check a day or two before the Resident
became ill; or that Petitioner’s staff failed to contact the
Resident’s physician the preceding morning when his blood
sugar was measured as low. These matters did not support the
sanction CMS imposed, which focused on Petitioner’s staff’s
acts and omissions after the Resident’s blood sugar was
determined to be normal on the morning of June 22, 2006.

P.Cl. Br. at 3.
Petitioner received ample notice from both the State Agency and CMS that the penalties

imposed were based on the findings enumerated in the Statement of Deficiencies (CMS
Form 2567). P. Ex. 2; CMS Exs. 8, 10.

'S(._ continued)
findings. Indeed, while compliance with all Medicare long term care requirements is
important, the quality of care regulation is particularly important because it encompasses
the purpose of skilled nursing care. Medicare pays for placement in skilled nursing
facilities in order for residents to receive the quality of care described in the regulation.
16

This is not even a situation in which CMS has asked me to look beyond the four corners
of the Statement of Deficiencies, which I am empowered to do. Pacific Regency Arvin,
DAB No. 1823, at 9 (2002); Regency Gardens Nursing Center, DAB No. 1858, at 15-16
(2002). Rather, Petitioner’s argument simply disregards the contents of that document.
CMS Ex. 2; P. Ex. 1. All of the issues Petitioner characterizes as “not supporting the
sanction,” are specifically listed there in support of the sanction.

The Statement of Deficiencies cites the regulatory requirements that were not met, and
then explains why those requirements were not met. In its explanations, it includes
(among other deficiencies) all of the matters that Petitioner now argues are not before me.
The Statement of Deficiencies talks about the problems with the physician’s “standing
orders” for sliding scale insulin (P. Ex. 1, at 2, 11, 14); it talks about staff’s failure to test
blood sugar on the days prior to the significant change in R1’s condition (P. Ex. 1, at 3,
16); it talks about the staff’s failure to contact the attending physician on the morning
prior to the significant change in R1’s condition (P. Ex. 1, at 4-5, 17). See also CMS Ex.
11 (Summary of Survey Findings); CMS Ex. 12 (Review of Survey Material, July 6,
2006).

Cc. CMS ’s determination that the facility’s deficiencies posed
immediate jeopardy to its residents was not clearly
erroneous.

I next consider whether CMS’s immediate jeopardy finding was “clearly erroneous.”
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. CMS’s
determination as to the level of a facility’s noncompliance — which includes its immediate
jeopardy finding — must be upheld unless it is “clearly erroneous.” 42 C.F.R. § 498.60(c).

The Board has observed repeatedly that the “clearly erroneous” standard imposes on
facilities a “heavy burden” to show no immediate jeopardy, and has sustained
determinations of immediate jeopardy where CMS presented evidence “from which
“‘[oJne could reasonably conclude’ that immediate jeopardy exists.” Barbourville Nursing
Home, DAB No. 1962, at 11 (2005) (citing Florence Park Care Center, DAB No. 1931,
at 27-28 (2004) (citing Koester Pavilion, DAB No. 1750 (2000)). Here, the facility has
not satisfied its burden.

Petitioner concedes that R1’s diabetic crisis “could have caused harm” but argues no
connection between the facility’s actions (or inactions) in this regard and potential harm
to aresident. P. Cl. Br. at 35. In fact, R1’s trip to the emergency room and subsequent
hospitalization were directly related to the facility’s general inattention to his diabetes and
its deficient response to his changed condition on the morning of June 22. Moreover,
17

Petitioner’s multiple shortcomings in assessing, planning, and managing R1’s diabetes, as
well as its overall failure to give its staff clear direction for consulting the physician about
a resident’s abnormal blood sugar levels, placed the facility’s diabetic residents at
immediate risk for serious injury, harm, or even death.

am therefore not able to find clearly erroneous CMS’s determination that the facility’s
deficiencies posed immediate jeopardy to resident health and safety.

IV. Conclusion

For all of the reasons discussed above, I find that, from June 22 through August 8, 2006,
the facility was not in compliance with program requirements, specifically, 42 C.F.R.

§§ 483.25 (quality of care) and 483.10(b)(11) (notification of changes). From June 22
through 27, 2006, its deficiencies posed immediate jeopardy to resident health and safety.
Because CMS has imposed the statutory and regulatory minimum per day penalty
amounts, I also sustain the $3050 per day CMP for the period of immediate jeopardy, and
the $50 per day CMP for the period of noncompliance that did not pose immediate

jeopardy.

/s/
Carolyn Cozad Hughes
Administrative Law Judge