Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

In the Case of: )
)
Golden Living Center — Frankfurt ) Date: July 29, 2009

(CCN: 18-5159), )
)
Petitioner, )
)

-V.- ) Docket No. C-08-363

) Decision No. CR1981
Centers for Medicare & Medicaid )
Services. )
)

DECISION

Petitioner, Golden Living Center — Frankfurt (Petitioner or facility), is a long-term care
facility located in Frankfurt, Kentucky, that participates in the Medicare program. Based
primarily on the facility’s treatment of one of its residents — who was admitted to the
hospital “very clearly dehydrated” and suffering from acute renal failure — the Centers for
Medicare and Medicaid Services (CMS) determined that the facility was not in
substantial compliance with Medicare requirements, and that its deficiencies posed
immediate jeopardy to resident health and safety. Petitioner here challenges those
determinations.

I conclude that, from December 15, 2007, through March 2, 2008, the facility was not in
substantial compliance with Medicare requirements, and that, from December 15, 2007,
through January 28, 2008, its deficiencies posed immediate jeopardy to resident health
and safety.

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 those statutory provisions. Act § 1819. The
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 CFR. § 488.301.

The Secretary contracts with state survey agencies to conduct periodic surveys to
determine whether skilled nursing facilities are in substantial compliance. Act § 1864(a);
42 C.F.R. § 488.20. The regulations require that each facility be surveyed once every 12
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.

Here, following surveys completed January 4 and January 30, 2008, CMS determined
that the facility was not in substantial compliance with the following Medicare
participation requirements:

42 C.F.R. § 483.25 (quality of care)

e 42 C.F.R. § 483.25(j) (quality of care — hydration)

e 42C.F.R. § 483.75(j) (administration — laboratory services)

e 42C.F.R. § 483.75(0) (administration — quality assessment and assurance)
© 42 C.F.R. § 483.20(k)(3) (comprehensive care plans)

CMS also determined that the facility’s deficiencies posed immediate jeopardy to
resident health and safety. CMS subsequently determined that the immediate jeopardy
abated effective January 29, 2008, and that the facility returned to substantial compliance
on March 3, 2008. CMS Ex. 1; CMS Ex. 3, at 30-33; P. Exs. 1, 2, 37.

CMS has imposed against the facility a civil money penalty (CMP) of $3750 per day for

the period of immediate jeopardy (45 days x $3750 = $168,750) and $100 per day for the
period of substantial noncompliance that was not immediate jeopardy (34 days x $100 =

$3400) (Total CMP: $172,150).

held a hearing in Louisville, Kentucky, on February 18, 2009. Mr. Joseph L. Bianculli
appeared on behalf of Petitioner, and Mr. Howard Lewis appeared on behalf of CMS. I
have admitted into evidence CMS Exs. 1-19, and P. Exs. 1-43 (including P. Exs. 10A and
27A). Order (October 10, 2008); Tr. 3. The parties have filed initial briefs (CMS Br.; P.
Br.), closing briefs (CMS Cl. Br.; P. Cl. Br.), and reply briefs (CMS Reply; P. Reply).
II. Issues
The issues before me are:

e Whether, from December 15, 2007, through March 2, 2008, the facility was in
substantial compliance with Medicare participation requirements, specifically 42
C.F.R. §§ 483.25, 483.25(j), 483.75(j), 483.75(0) and 483.20(k)(3);

e Ifthe facility was not in substantial compliance from December 15, 2007, through
January 28, 2008, did its deficiencies then pose immediate jeopardy to resident
health and safety?

Even though Petitioner’s hearing request mentions, without further comment, that it
“specifically challenges the amount and duration of the CMP,” the reasonableness of the
CMP is not before me. My pre-hearing order said that the party’s pre-hearing brief “must
contain any argument that a party intends to make” and warned that “I may exclude an
argument and evidence that relates to such argument if a party fails to address it in its
pre-hearing brief.” Acknowledgment and Initial Pre-hearing Order, at 4 (April 4, 2008).
Accordingly, CMS argued in its pre-hearing brief that the amount of the CMP was
reasonable; however, Petitioner’s subsequently-filed pre-hearing brief includes no
argument as to the reasonableness of the CMP. During the October 9, 2008 pre-hearing
conference (see 42 C.F.R. 498.47(a)), I pointed out that Petitioner had not challenged the
amount of the penalty; my subsequent order listed the issues before me, and explicitly
held that “except to argue its substantial compliance, Petitioner’s pre-hearing brief does
not challenge the reasonableness of the civil money penalty.” Order (October 10, 2008).
Petitioner did not subsequently object to that articulation of the issues, and the ruling is
final. 42 C.F.R. § 498.50(b) (parties have 10 days to file objections to the pre-hearing
order; after 10 days have elapsed, the ALJ settles the order). Therefore, the
reasonableness of the CMP is not before me.’

' Petitioner may have confused the issue of the CMP’s duration with the issue of
the CMP’s reasonableness, claiming that “[t]he Court suggested at the hearing that
Petitioner had waived any challenge to the duration of the CMP.” P. Cl. Br. at 43, note
10. In fact, at the hearing I repeated what I had said during the pre-hearing conference
and in my October 10, 2008 order: “[E]xcept to argue its substantial compliance,
Petitioner’s pre-hearing brief does not challenge the reasonableness of the civil money
penalty.” Tr. 2. Since the duration of the penalties is coterminous with the periods of
substantial noncompliance and immediate jeopardy, the issues of duration are necessarily
before me, as reflected in the above statement of the issues. (““Whether, from December
15, 2007, through March 2, 2008, the facility was in substantial compliance.”; “If the
facility was not in substantial compliance from December 15, 2007, through January 28,
2008, did its deficiencies then pose immediate jeopardy .. . .”). However the
reasonableness of the amount is a separate issue, which Petitioner has waived.

II. Discussion

The deficiencies cited in this case center around care provided to Resident 1 (R1). Rl
was a 66-year-old woman admitted to the facility on December 7, 2007, following a
week-long stay at an acute care hospital. Among her many health issues, she had
histories of coronary artery disease, congestive heart failure, massive cerebrovascular
accident (stroke), seizure disorder and chronic kidney disease. She suffered from
hypotension and gout. CMS Ex. 4, at 2-5, 11-12, 375; CMS Ex. 10, at 13-15; CMS Ex.
17, at 2 (Fink Decl. § 7); P. Ex. 4; Tr. 10. Nevertheless, when admitted to the facility, her
condition was stable. Tr. 23, 28-29. She had some modest impairment of her kidney
function, but, as explained by CMS’s expert witness, Dr. Jeffrey C. Fink,’ lab results
showed “acceptable renal function at the time and only mild renal impairment related to
chronic kidney disease.” CMS Ex. 17, at 3, 4, 6 (Fink Decl. § 10, 11, 16); CMS Ex. 4,
at 66; Tr. 8; P. Ex. 32, at 2 (Payton Decl.) (lab tests generally normal with slightly
elevated BUN, which appeared to have been her baseline). R1 had a history of fluid
imbalances and was assessed as at risk for dehydration; however, no evidence suggests
that she was dehydrated or experiencing any other nutritional problems at the time of her
admission. CMS Ex. 17, at 4 (Fink Decl. § 12); CMS Ex. 10, at 23-29. Petitioner’s
expert witness, Dr. Michael Yao, Division Medical Director for Petitioner’s parent
company, agreed that “overall . .. she may have been in pretty good balance as far as her
record of balance has been at that moment....” Tr. 151. She was capable of feeding
herself, and had no difficulty chewing or swallowing food or drink. CMS Ex. 9, at 36;
CMS Ex. 10, at 25.

Thereafter, however, R1’s condition deteriorated until — just 18 days after her admission
— she was hospitalized with severe dehydration and dangerously high potassium levels.
In CMS’s view, facility staff contributed to her decline because (among other
deficiencies) they: 1) failed to provide her with sufficient fluid intake to maintain proper
hydration and health; 2) did not timely obtain necessary laboratory tests; 3) did not
develop an individualized care plan, nor provide, pursuant to such plan, services meeting
professional standards of quality; and 4) did not provide her the care and services she
needed to attain or maintain her highest practicable physical well-being.*

> Dr. Fink is an associate professor of Medicine and Epidemiology in the Division
of Nephrology at the University of Maryland School of Medicine. CMS Ex. 15; CMS
Ex. 17, at 1.

* I decline to rule on every deficiency cited, but discuss deficiencies that were
persuasively established and are sufficient to support the remedies imposed. Beechwood
Sanitarium, DAB No. 1824, at 19 (2002). No inference should be drawn as to the merits
of the cited deficiency on which I have declined to comment.
A, Because its staff did not provide R1 with fluid intake adequate to
maintain proper hydration and health, the facility was not in substantial
compliance with 42 C.F.R. § 483.25@).'

As part of the “quality of care” regulation (discussed below), the facility must “provide
each resident with sufficient fluid intake to maintain proper hydration and health.” 42
C.F.R. § 483.25(j). Where, as here, a resident is assessed as at risk for dehydration, I
consider first what the facility did to mitigate that risk. Whether the facility provided the
volume of fluids recommended by a resident’s dietician may be a critical part of that
consideration. Woodland Village, DAB No. 2053, at 10 (2006).

R1’s care plan, dated December 7, 2007, indicates that she was at risk for dehydration.
CMS Ex. 11, at 2; see P. Reply at 20 (“But no reasonable person could find on the current
record that Petitioner’s staff was unaware that the [r]esident was at risk for
dehydration.”). Although not mentioned in the plan or in her attending physician’s
assessment, she was apparently at risk for both dehydration and fluid overload, and, thus,
her fluids should have been very closely monitored. Tr. 111.°

On December 11, 2007, the facility’s registered dietician assessed R1 as requiring 2170
milliliters (mls) of fluid per day, and no one disputes that the dietician’s assessment
represents the most precise estimate of the resident’s fluid needs. CMS Ex. 9, at 38.
Nurse Practitioner Payton, who provided direct care to R1, testified that she would defer
to the opinion of the dietician as to the amount of fluid a resident required. Tr. 136-37.

But the facility fell far short of providing R1 the level of fluids called for in her
assessment. Review of the intake records offered by Petitioner shows that R1 did not
consume anywhere near the amount she required, never consuming more than 960 ml,

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

* As discussed below, Dr. James Quarles, who was R1’s attending physician and
the facility’s medical director, purportedly examined and assessed R1 on December 13,
about a week following her admission. As his written report shows, he seems to have
missed completely what Dr. Yao and Dr. Fink characterize as her most critical problem —
difficulty maintaining adequate fluid balance. P. Ex. 5; see Tr. 161 (Per Dr. Yao:
“{T]here isn’t any mention of the difficulties in dealing with fluids that I would expect to
have seen.”). And, as discussed below, Advanced Registered Nurse Practitioner Susan
Payton (who treated R1) came late to recognizing the severity of R1’s fluid balance
problems. P. Ex. 38, at 3, 6 (Payton Decl.).
6

and more often consuming as few as 240 ml. P. Ex. 20. Specifically, Petitioner presents
R1’s daily fluid intake as follows:

e 12/8—240 ml.
© 12/9-960 ml.
e 12/10—720 ml.
e 12/11—360 ml.
e 12/12—-360 ml.
e 12/13 — nothing recorded.
e 12/14—480 ml.
e 12/15—240 ml.
e 12/16—240 ml.
e 12/17—240 ml.
e 12/18 —480 ml.
e 12/19-620 ml.
e 12/20-480 ml.
e 12/21—240 ml.
e 12/22-360 ml.
e 12/23-600 ml.
e 12/24—720 ml.

P. Ex. 20; see P. Ex. 41 (Stonewall Decl.).° These dramatic figures, by themselves, could
put the facility out of substantial compliance with section 483.25(j), particularly where,
as here, no evidence suggests that the facility recognized or addressed the problem. See
Claiborne-Hughes Health Center, DAB No. 2233, at 9 (2008) (“A facility’s record of
fluid intake, or lack thereof, can be relevant in determining whether a resident was
provided with sufficient fluid intake to maintain proper hydration and health.”).

° But see CMS Ex. 9, at 9, 10. The parties have offered discrepant versions of
R1’s intake. CMS offers a one-page document titled “Intake and Output Record,” which
shows that the facility staff only began recording R1’s intake on December 17, contrary
to facility protocol, under which they should have been recording intake at least as of a
December 14 order to “push fluids.” CMS Ex. 9, at 9. No one has explained the entries
on the intake record, and it is difficult to determine what they mean, but, under any
interpretation, the intake numbers recorded do not approach 2170 mls per day. CMS
maintains that the facility only began to measure intake on December 17, days after
Nurse Practitioner Payton ordered staff to “push fluids.” But the above figures suggest
that the facility measured intake from December 8 on — although not necessarily in the
manner called for by the facility’s written protocol. See CMS Ex. 12. Of course, that the
facility apparently maintained inconsistent records of the resident’s intake is itself deeply
troubling.

Thereafter, R1’s hydration needs became more acute. By December 12, Nurse
Practitioner Payton detected abnormal lung sounds and a December 13, 2007 chest x-ray
confirmed that R1 had pneumonia. CMS Ex. 7, at 15; CMS Ex. 8, at 3. In an order dated
December 14, Nurse Practitioner Payton directed staff to “push fluids.” CMS Ex. 7, at
16.

According to the facility’s protocol, when ordered to “push fluids,” staff were also
required to monitor the resident’s fluid intake and, where feasible, her output. Because
R1 could not eliminate in a measuring device, the protocol apparently excused staff from
measuring output. CMS Ex. 12. Nevertheless, the protocol dictated that staff measure
her intake, record it at the end of each shift, and record the daily total. Presumably,
nurses and/or R1’s attending physician were supposed to review the daily totals and, if
they showed that she was not ingesting sufficient fluids, they would reassess and/or
adjust her care plan. Dr. Yao explained that measuring intake is very labor intensive, but
agreed that requiring staff to do so is “a reasonable expectation.” Tr. 151, 158.

Staff's monitoring appears to have been inconsistent. More important, however, the
above numbers indicate that Nurse Practitioner Payton’s “push fluids” order had no
apparent effect on facility performance in keeping R1 hydrated. At no time before or

after issuance of the December 14 order did R1’s intake come close to her assessed need.

Petitioner does not dispute its own figures, but claims that “[t]his definitely is not a case
where indifferent or careless nurses simply failed to administer sufficient fluids to an ill
resident.” P. Br. at 33. In fact, whether due to indifference, carelessness, incompetence,
oversight, or some other reason, this is undeniably a case where staff failed to administer
sufficient fluids to an ill resident. Staff were, or should have been, aware that R1 did not
consume anywhere near the amount of fluid she required; yet, I see no evidence of any
systematic effort to increase that fluid intake.

Indeed, the evidence suggests that those responsible for her care did not even recognize a
serious problem. Licensed Practical Nurse (LPN) Evelyn Atha testified that, although
trained “to be alert to hydration issues[,]” she did not recall R1 having “any problem of
this sort. In fact, I recall that she drank a lot when I cared for her, that we always offered
her fluids, and that she drank adequate amounts of fluid.” P. Ex. 40. In contrast, a couple
of the certified nurse assistants testified that they offered fluids (water, juice, soda) to R1,
and encouraged her to drink, but she often refused. They also said that they reported her
consumption to the nurses. P. Ex. 42, at 2 (Mahan Decl.); P. Ex. 43 (Brown Decl.). It
does not appear that the facility took any particular action based on the CNAs’ reports.

In her written declaration, Nurse Practitioner Payton expresses no concern for R1’s low
fluid intake. She says that she ordered staff to “‘push fluids” because R1 had an infection,
suffered from chronic diarrhea, and frequently refused to eat or drink. But, when Nurse
Practitioner Payton first saw R1 on December 12, she did not think she was dehydrated,
and “nothing subsequent to that time indicates that the [r]esident’s hydration status
changed significantly or required any specific intervention.” P. Ex. 38, at 3, 6 (Payton
Decl.).’ I find this statement troubling because it appears to disregard multiple symptoms
exhibited by R1 that are consistent with dehydration.

On the afternoon of December 15, R1 exhibited what staff characterized as “a slight
change in mental status,” in that she was “picking at the air” and “talking to the wall.”
CMS Ex. 8, at 4. These can be symptoms of dehydration. Tr. 124. At her son’s
insistence, she was taken to the emergency room. P. Ex. 38 (Payton Decl.). While there,
lab tests showed that her potassium level was 6.0, which is considered extremely high
(normal range is between 3.5 and 5.0-5.3).° She was diagnosed with hyperkalemia, and
treated with Kayexalate, a medication commonly given to reduce potassium levels, even
though it causes diarrhea. CMS Ex. 5, at 4, 24, 28; CMS Ex. 7, at 7; CMS Ex. 17, at 5
(Fink Decl. § 14); Tr. 35. She returned to the facility and her potassium pills were
withheld on the 16" and 17", but resumed thereafter. CMS Ex. 9, at 44.

The December 15 lab tests also showed that R1’s creatinine level was significantly higher
than it had been when she was admitted to the facility, having climbed from 1.2
(adequate renal function) to 1.6 with an estimated GFR (glomerular filtration rate) of 34
ml/min. CMS Ex. 4, at 66; CMS Ex. 5, at 4. Dr. Fink explained that this change
indicates worsening kidney function because of volume depletion and dehydration. The
high level is a signal that kidney function is beginning to decline, so R1 needed to be
watched even more closely. CMS Ex. 17, at 6 (Fink Decl. § 16). Dr. Fink explained:
potassium is an electrolyte, and the kidneys excrete electrolytes out of the body. If the
kidneys are impaired, their ability to eliminate potassium and other electrolytes
deteriorates. High potassium levels can cause cardiac arrhythmias. As dehydration and
volume depletion worsen, acute renal dysfunction can become prolonged renal failure.
CMS Ex. 17, at 6-7 (Fink Decl. § 16).

7 [ reject as unsupported Petitioner’s after-the-fact, but repeated, suggestion that
the facility’s only alternative to providing R1 with a small fraction of her fluid needs
would have been to administer intravenous fluids. No contemporaneous note or
assessment mentions that Dr. Quarles or Nurse Practitioner Payton considered
administering IV fluids or instituting any less intrusive intervention to increase R1’s fluid
intake.

* Nurse Practitioner Payton claims simply that R1’s potassium levels “were a little
high” (P. Ex. 38, at 4), which suggests that she did not appreciate the seriousness of the
test result. The record does not reflect that Dr. Quarles had any opinion on the matter.
See discussion, infra. This may explain why the facility resumed her potassium pills after
only two days, and did not thereafter monitor her potassium levels.
Between December 15 and her hospital admission on December 25, R1 experienced 13
documented episodes of diarrhea. CMS Ex. 9, at 73-74. As Dr. Fink explained, diarrhea
increases water and electrolyte loss. It can cause severe dehydration, volume depletion,
shock and can even lead to death. CMS Ex. 17, at 7 (Fink Decl. § 17). I agree with Dr.
Fink that the facility should have recognized the risk. Moreover, R1’s deterioration
should have been observed during routine assessments. Signs of dehydration include
drop in blood pressure, poor skin turgor, dry mucus membranes, and change in mental
status. CMS Ex. 17, at 7 (Fink Decl.)

In addition, R1 lost a significant amount of weight. Upon admission, R1 weighed 191
pounds. Eleven days later, her weight had dropped to 183.7 pounds. CMS Ex. 9, at 37.
Dr. Fink explained that the substantial rapid weight loss was likely due to dehydration.
CMS Ex. 17, at 7-8 (Fink Decl. § 18).

Nurses notes dated December 18 and December 22, 2007 describe R1 as “groggy” and
“very drowsy.” On December 22 she refused to eat. CMS Ex. 8, at 5. Staff took no
action.

Her deterioration continued, and, by December 25, she was “slow to arouse,” her speech
difficult to understand. Staff notified Nurse Practitioner Payton who ordered her
transferred to the hospital. CMS Ex. 8, at 6. At the hospital, she was described as
“clearly very dehydrated.” CMS Ex. 6, at 1. Her potassium level was 7.4. She was
admitted to the hospital with acute renal failure, hyperkalemia, sepsis, pneumonia and
acute dehydration. CMS Ex. 6, at 1-3; CMS Ex. 17, at 8; see Tr. 111, 113, 122, 128, 142
(Per Dr. Yao: R1 “had a degree of dehydration that did require rehydration.”). Tr. 142.

Thus, facility staff did not follow dietician recommendations as to R1’s fluid needs, did
not respond to Nurse Practitioner Payton’s order to “push fluids,” and did not respond
when R1 exhibited signs and symptoms of dehydration. They did not even alter her care
after December 15 lab tests showed abnormal creatinine levels, which pointed to
worsening kidney function, likely due to volume depletion and dehydration. The facility
was not providing R1 sufficient fluid intake to maintain proper hydration and health, and
was therefore not in substantial compliance with 42 C.F.R. § 483.25(j).

B. The facility was not in substantial compliance with 42 C.F.R.
§ 483.75(j) because it did not timely obtain necessary laboratory tests.

The facility must also provide or obtain laboratory services “to meet the needs of its
residents[,]” and is responsible for the quality and timeliness of those services. Among
other requirements, it must obtain the services only when ordered by the attending
physician; it must promptly notify the attending physician of the laboratory test results;
and it must file the dated lab reports in the resident’s clinical record. 42 C.F.R.
§ 483.75(j).”

On December 12, 2007, when Nurse Practitioner Payton detected R1’s abnormal lung
sounds, she ordered laboratory tests as well as the chest x-ray mentioned above.
According to Nurse Practitioner Payton, the ordered tests “were very important for
multiple issues.” CMS Ex. 7, at 16; Tr. 118. But the facility did not implement that
order. Several days later, a nurse apparently noticed that the tests had not been
performed, and the facility finally did so on December 17, 2007. CMS Ex. 8, at 4, 5 (per
December 16 nurse’s note: “S. Payton ARNP wrote orders for labs to be drawn on
12/13/2007. ... Called S. Payton to inform of no lab draw. New orders rec’d to do labs
in AM.”)

Witnesses for both parties agreed that the delay in testing created serious problems. Too
much potassium in the blood can cause extremely serious medical issues, possibly even
death. CMS Ex. 17, at 5 (Fink Decl. § 14). But, because no specific symptoms signify
the condition, a lab test is the only means by which to discover high potassium levels. Tr.
47. As Dr. Fink explained, the lab tests provide crucial information and, had the labs
been obtained as ordered on the 12", the test results would have reflected an increasing
potassium level, and R1’s hyperkalemia could therefore have been treated before it
reached dangerous levels. Tr. 46-47, 135; CMS Ex. 17, at 5-6 (Fink Decl. § 15).

Petitioner mischaracterizes Dr. Fink’s testimony when it suggests that Dr. Fink
“conceded that the impact of this error — if any — was vitiated when the Resident actually
received the lab test and treatment on December 15.” P. Cl. Br. at 2. In fact, Dr. Fink
simply agreed that the treatment administered in the hospital on the 15" halted and
reversed the deterioration in R1’s condition (“sets the clock differently . . . resets it back
to zero.”). Dr. Fink immediately followed up by opining that, had the labs been obtained
as ordered on the 12", the test results would have reflected an increasing potassium
level, as well as her deteriorating renal function and “may have prevented the emergency
room visit.” CMS Ex. 17, at 5-6 (Fink Decl. § 15), Tr. 46-47.

° A physician may delegate tasks to a physician assistant, nurse practitioner, or
clinical nurse specialist if certain criteria are met. 42 C.F.R. § 483.40(e).

Petitioner claims that its “routine systems for catching errors worked as
designed and intended to catch this error.” P. Cl. Br. at 37. But no evidence suggests
that the facility had such a system. In fact, Petitioner is not even able to explain how the
error was found, much less describe any systematic approach. Rather, Petitioner
speculates that the nurse may have discovered the error in response to Nurse Practitioner
Payton’s query about the test results, or she may have discovered the error when
performing a chart audit.
Dr. Yao testified that he would have preferred “more than one lab” (Tr. 144-45) and that
“if you order a lab, you should expect it to be done.” Tr. 158, 167. He conceded that the
care provided “was clearly not perfect” and “things could have been done better,
including getting labs in a timely fashion,” but opined that, inasmuch as the problem was
detected and treated on December 15, “there wasn’t a lasting harm initiated from that.”
Tr. 168-69. That the facility, through happenstance, may have avoided inflicting
permanent harm is hardly the standard by which we judge either substantial compliance
or immediate jeopardy.

For her part, Nurse Practitioner Payton characterized the delay in testing as “the downfall
of this entire situation[,]” making it difficult for her to do her job, and I see no reason to
question that opinion. P. Ex. 32, at 2; Tr. 119-20, 134.

Because the facility did not timely obtain very important laboratory tests, it was not in
substantial compliance with 42 C.F.R. § 483.75(j).

C. The facility was not in substantial compliance with 42 C.F.R.
§ 483.20(k) because it did not develop for R1 an individualized care plan,
nor provide services meeting professional standards of quality.

42 C.F.R. § 483.20(k)(1) and (3) mandate: 1) that the facility develop for each resident a
comprehensive care plan with measurable objectives and timetables to meet the resident’s
medical, nursing, mental, and psychosocial needs as identified in the resident’s
comprehensive assessment; and 2) that the services provided or arranged by the facility
pursuant to that plan meet professional standards of quality.

First, I agree with CMS that, because it failed to obtain timely lab tests for R1, the facility
did not provide services meeting professional standards of quality. I also find that the
facility fell short of meeting professional standards of quality because it did not provide
R1 with fluids adequate to maintain proper hydration.

With respect to the requirement that the facility develop a comprehensive care plan for
R1, Petitioner argues that R1 was not in the facility long enough to trigger the
comprehensive care planning requirements. P. Reply, at 23. Petitioner is incorrect. The
regulation requires development of a care plan within seven days after completion of the
resident’s comprehensive assessment. 42 C.F.R. § 483.20(2)(i). The comprehensive
assessment is due within 14 days of admission. 42 C.F.R. § 483.20(b)(2)(i). Petitioner
has submitted a “clinical assessment” dated December 7, 2007. P. Ex. 7; CMS Ex. 10, at
23-29. If this is the facility’s comprehensive assessment, R1’s care plan should have
been completed no later than December 21, 2007. More likely, Petitioner considered this
part of R1’s comprehensive assessment and incorporated it into another document, dated
December 14, 2007, that represents the comprehensive assessment. R1’s care plan
therefore had to be developed no later than December 28, 2007, and, in fact, the facility
developed a plan of sorts on that date. CMS Ex. 10.

At the time of her admission, the facility recognized that R1 was at risk for dehydration,
and prepared a “care plan” that says simply “[no signs or symptoms of] dehydration
[without] detection [and] intervention through next review.” CMS Ex. 11, at 2; P. Ex. 8,
at 1. Although an interim plan, it should have provided sufficient instructions to enable
staff to care adequately for the resident, but it did not.

An amended plan was completed on December 28.'' While more comprehensible than
the earlier version, it offers little in the way of meaningful instructions to staff. The
amended plan identifies R1’s problem as “risk for dehydration /fluid imbalance related to
[history] of CHF and pneumonia.” But the interventions are generic: weigh monthly and
as needed; labs as ordered — report abnormals; report signs and symptoms of dehydration;
encourage fluids as tolerated; and “push fluids.” CMS Ex. 11, at 5; P. Ex. 8, at 14. The
plan does not reflect R1’s assessment in that it says nothing about the quantity of fluids
R1 required. It does not address staff’s total lack of success in providing R1 anywhere
near the volume of fluid she required.

Petitioner chides CMS for its purported failure to acknowledge that R1 had “significant
nutritional problems, including persistent refusals to eat and drink (and that those issues
further complicated management of her already complicated medical problems).” P.
Reply, at 7. However, Petitioner points to no evidence suggesting that, following an
appropriate assessment of R1’s nutritional problems, an interdisciplinary team (that
included her attending physician) developed a care plan with measurable objectives and
timetables to address those “significant nutritional problems.”

Nor does the plan address R1’s dangerously high potassium levels; indeed, I see no
evidence that the interdisciplinary team charged with planning R1’s care ever considered
the wisdom of resuming potassium pills after only two days respite, and without at least
monitoring her potassium blood levels.

Thus, while Petitioner developed care plans for R1, they were inadequate. For this
reason, and because it provided services that did not meet professional standards of
quality, the facility was not in substantial compliance with 42 C.F.R. § 483.20(k).

"' The facility prepared this care plan in anticipation of R1’s return to the facility
following her hospitalization. However, when discharged from the hospital on January 4,
2008, R1 opted not to return to the facility. Nevertheless, as of December 28, the facility
was required to develop a care plan for R1, and the fact that it was ultimately not
implemented does not change the fact that the facility failed to develop an adequate plan.
D. The facility was not in substantial compliance with 42 C.F.R.
§ 483.25 because it did not provide R1 the care and services she needed to
attain or maintain her highest practicable physical well-being.

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.

I have already discussed the facility’s failure to provide R1 with adequate fluid intake,
and its failure to obtain timely laboratory tests that the resident required. These
eficiencies, by themselves, establish that the facility was not providing necessary care.

The facility failed to provide necessary care and services in other significant respects.
Following her December 15 emergency room visit, it did not give her the care and
services she needed to prevent dangerously high potassium levels. As noted above, on
December 15, R1’s potassium was extremely high, at 6.0. As Dr. Fink noted, excessive
potassium administration can cause complications in patients with R1’s level of kidney
unction. CMS Ex. 17, at 4-5 (Fink Decl. J 13), Tr. 33. Yet, except for the two days
immediately following that emergency room visit (December 16 and 17), R1 was
administered potassium pills from the time of her admission on December 7 until her
ospital admission on December 25, 2007. CMS Ex. 9, at 44. And the record contains
no apparent justification for continuing the medication. Dr. Fink points out that
potassium is commonly prescribed with the diuretic Lasix, which R1 had been taking
immediately prior to her first hospitalization. CMS Ex. 17, at 4 (Fink Decl. § 13); CMS
Ex. 4, at 40. Lasix frequently causes potassium excretion by the kidneys. But the Lasix
was discontinued by December 2, so she was no longer receiving it at the time of her
admission to the facility. Yet, no one at the facility re-evaluated the wisdom of
continuing the potassium. Nor did the facility make any effort to monitor her potassium
blood levels. Someone — the attending physician, nurse practitioner, or consultant
pharmacist — should have reviewed the decision to continue the medication. Tr. 34. If
the medication were ultimately deemed appropriate, periodic laboratory tests would at
least have alerted R1’s treaters to any dangerous increase in her potassium level. As Dr.
Yao noted, daily labs may not be the standard of care for a skilled nursing facility, but
“there are times when a resident will go through a rough patch where you may have to
get labs for a few days.” Tr. 158.

Petitioner claims that R1’s attending physician and Nurse Practitioner Payton
“consistently walked a tightrope” to avoid the equally serious complications of
dehydration, on the one hand, and fluid overload on the other... .” P. Reply, at 19. But
the record does not support this proposition. In fact, the evidence shows exactly the
opposite. I have already discussed Nurse Practitioner Payton’s admission that she did

not, at the time she assessed R1 or any time thereafter, observe any problem with R1’s
hydration status nor see any need to intervene. P. Ex. 38, at 3, 6. And, as the discussion
above shows, R1’s treatment records support the conclusion that, except for her
generally disregarded orders for lab tests and to “push fluids,” Nurse Practitioner Payton
did not intervene in order to maintain an adequate fluid balance for R1.

For his part, Dr. Quarles, R1’s nominal attending physician and the facility’s medical
director, overlooked entirely any potential complications. His assessment

listed a history of medical problems, but his “review of systems” was essentially
negative, and, his physical examination describes R1 as “in general a well-appearing
[white female] in no apparent distress;” her coronary artery disease is stable; her gout is
stable; her hypertension controlled. He concludes the assessment with “once she is
strong enough to go back home, she may be discharged.” P. Ex. 5. Petitioner’s own
expert was critical of Dr. Quarles’ assessment. Dr. Yao pointed out that the resident’s
attending physician is ultimately responsible for the resident’s care, and noted that the
assessment included no “mention of the difficulties in dealing with fluids that I would
expect to have seen on this, and that I did see in the [hospital] discharge summary.”
Tr. 161.

Dr. Yao also rejected the suggestion that the facility is not accountable for the
inadequacies of care attributable to an attending physician. He testified, accurately, that,
as both R1’s attending physician and the facility’s medical director, Dr. Quarles’
obligations under the regulations were two-fold:

[I]f somebody is deemed not to be getting the kind of care that they should
be getting from their attending physician, the medical director’s
responsibilities are two-fold. The medical director may have to intervene in
terms of additional care, okaying a transfer, calling in orders... . But also a
medical director does have to look at the system and say, gee, should this
attending physician be on staff and . . . are there things that we can do in
our facility that can decrease the risk of this happening again?

Tr. 165; see also Tr. 160, 164-65."

Finally, Petitioner makes much of R1’s fragility and complicated health issues. But, for
this very reason, she required especially careful assessment and monitoring, and the
facility had a heightened duty to provide her the care she needed. Tr. 163-164. Drs. Fink
and Yao agreed that the facility needed to be extra diligent when monitoring R1’s

» Although he did not cite to the specific regulations, Dr. Yao was referring to 42
C.F.R. § 483.75(i), which makes the medical director responsible for implementing
resident care policies and coordinating medical care within the facility, and § 483.40,
which governs physician services within the facility.
hydration. Tr. 149. Because identifying when such a patient is fluid overloaded or
depleted or insufficient in her volume status can be confusing, such individuals “require
day-to-day observation and assessment to properly manage them... .” Tr. 22.

Moreover, the problem here was not that the facility fell short of providing a complicated
level of care; rather, the facility failed to provide even an ordinary level of care. Staff did
not give this woman (who was fully capable of eating and drinking on her own)
anywhere near the level of fluid she required; they delayed obtaining a necessary lab test;
they did not develop an individualized care plan; no one considered why they should
continue to administer potassium to someone who no longer took a potassium-depleting
medication, and who had experienced dangerously high potassium levels; and, her
attending physician did not even appear to recognize her most serious problems. R1’s
care may have been “challenging,” but the facility did not even provide a level of care
sufficient to address the problems of a resident without any significant complications.

For all of these reasons, I find that the facility was not providing R1 the care and services
she needed to attain or maintain her highest practicable physical well-being and was
therefore not in substantial compliance with 42 C.F.R. § 483.25.

E. CMS’s finding of immediate jeopardy is 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 would include an
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
‘[o]ne 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)); Daughters of Miriam,
DAB No. 2067, at 7, 9 (2007).

I reject Petitioner’s suggestion that R1’s difficulties were simply the result of her
underlying ailments, and not attributable to the care she received. Under any standard,
the facility’s deficiencies posed immediate jeopardy, because they caused or were likely
to cause serious harm. Specifically:

e A seriously ill resident, identified as at risk for dehydration, received only a small
fraction of the fluids she required. Not surprisingly, she ended up in the hospital
with severe dehydration. I consider severe dehydration to be serious harm, and I
find that the facility’s failure to keep her adequately hydrated likely caused that
harm. In any event, not meeting the identified hydration needs of someone at risk
for dehydration is likely to cause serious harm;

e The facility’s failure to obtain timely the ordered lab tests for this resident meant
that her rising potassium levels and deteriorating renal function went undetected
for at least two days — and could have gone undetected for up to four days, but for
her family’s insistence that she be sent to the emergency room;

e Even after R1 had been diagnosed with dangerously high potassium levels, neither
her attending physician, nurse practitioner, nor the facility’s consulting pharmacist
reviewed the decision to continue her potassium medication;

e Even after R1 had been diagnosed with dangerously high potassium levels, the
facility did not monitor her potassium levels, and she ended up hospitalized with
an even higher potassium level of 7.4, which subjected her to additional
complications.

Based on these instances of actual and potential harm, I find that CMS’s immediate
jeopardy determination is not clearly erroneous.

F. CMS’s determinations as to the duration of the noncompliance and
immediate jeopardy are consistent with statutory and regulatory
requirements.

Substantial compliance means not only that the specific cited instances of substandard
care were corrected, and that no other instances have occurred, but also that the facility
has implemented a plan of correction designed to assure that no such incidents occur in
the future. The burden is on the facility to prove that it has resumed complying with
program requirements, not on CMS to prove that deficiencies continued to exist after they
were discovered. Asbury Center at Johnson City, DAB No. 1815, at 19-20 (2002). A
facility’s return to substantial compliance usually must be established through a resurvey.
Cross Creek Care Center, DAB No. 1665 (1998); Hermina Traeye Memorial Nursing
Home, DAB No. 1810, at 12 (citing 42 C.F.R. § 488.454(a) and (e)).

Petitioner complains about the duration of the period of noncompliance and the period of
immediate jeopardy, claiming that all of its purported noncompliance occurred on or
before December 15, and that any risk of harm to R1 ended on that day. P. Cl. Br. at 43-
44. I find this assertion wholly unsupported and perplexing.

Even though CMS imposes its CMP as of December 15, the care provided R1 was
deficient from the date of her admission. And, as the above discussion shows, her care
did not improve following her December 15 emergency room visit. She continued to
receive only a fraction of the fluids she needed. P. Ex. 20. Knowing about her
significant problems with potassium, the facility continued, without further assessment,
to administer potassium to her. Prior to December 15, the facility had in place a deficient
care plan, and the plan it drafted on December 28 was also deficient.

Moreover, although the cited deficiencies affected R1 most dramatically, they
represented systemic problems relating to assessment, care planning, hydration, and
obtaining sufficient, timely lab tests. For example, facility staff did not recognize
symptoms of dehydration; they were not insuring that each resident receive the volume of
fluid recommended in his/her dietary assessment. To correct, facility nurses assessed
each resident for symptoms of dehydration. They initiated intake and output monitoring
for the facility’s at-risk residents to determine whether their fluid recommendations were
being met. They advised the attending physicians of those instances in which a resident
displayed symptoms of dehydration and/or was not receiving adequate fluids. Staff were
trained to recognize symptoms of dehydration. Similar actions were taken to address the
other deficiencies.

The facility told CMS the dates it completed these corrections. For the most part, it
finished identifying the at-risk residents and completed the staff’s in-service training by
the end of January 2008. The facility set March 3 as the date it completed all of its
corrections, and CMS apparently accepted the facility’s dates. CMS Ex. 1.

Because Petitioner has not established that an effective plan of correction was
implemented any earlier than that determined by CMS, I sustain CMS’s determinations
as to the duration of the periods of substantial noncompliance and immediate jeopardy.

IV. Conclusion

For the reasons discussed above, | find that, from December 15, 2007, through March 2,
2008, the facility was not in substantial compliance with Medicare requirements,
specifically, 42 C.F.R. §§ 483.25, 483.25(j), 483.75(j), and 483.20(k)(3). From
December 15, 2007, through January 28, 2008, its deficiencies posed immediate jeopardy
to resident health and safety.

/s/
Carolyn Cozad Hughes
Administrative Law Judge


Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

In the Case of: )
)
Embassy Health Care Center, ) Date: July 24, 2009

(CCN: 14-5316) )
)
Petitioner, )
)

-V.- ) Docket No. C-08-505

) Decision No. CR1980
Centers for Medicare & Medicaid )
Services. )
)

DECISION

I sustain the determination of the Centers for Medicare & Medicaid Services (CMS) to
impose remedies against Petitioner or facility, Embassy Health Care Center. The
remedies that I sustain include civil money penalties in daily amounts of $200 for each
day of a period that began on March 17, 2008 and ran through June 8, 2008, (84 days) for
a total civil money penalty of $16,800.

I. Background

Petitioner, located in Wilmington, Illinois, is authorized to participate in Medicare as a
skilled nursing facility (SNF) and in the Medicaid program as a nursing facility (NF).
Petitioner was subject to surveys by the Illinois Department of Public Health and Human
Services (state agency). On March 17, 2008, a complaint investigation was completed at
Petitioner’s facility by the state agency to determine if the facility was in compliance with
Federal requirements for nursing homes participating in the Medicare and Medicaid
programs. The survey found that the facility was not in substantial compliance at a
severity level that involved actual harm, but did not amount to immediate jeopardy. The
deficiency was cited as: F314 — scope and severity: G — 483.25(c) — pressure ulcers. On
April 1, 2008, the state agency conducted another complaint investigation at Petitioner’s
facility, which found that Petitioner was still not in substantial compliance with
participation requirements. The deficiency was cited as: F323 — scope and severity: G —
2

483.25(h) — accidents and supervision. CMS conducted additional surveys on May 16
and May 28, 2008, respectively in which additional deficiency findings were made at
F253 and F406.'

As a result of the survey findings, CMS determined to impose remedies including
directed in-service training effective May 1, 2008, a mandatory three-month denial of
payment for new admissions effective June 17, 2008, and a civil money penalty of $200
per day beginning March 17, 2008.

Petitioner timely requested a hearing before an administrative law judge (ALJ), and the
case was assigned to me for hearing and decision.

By agreement dated October 23, 2008, the parties stipulated that the scope of the hearing
would be limited to evidence related to the F314 and F323 tags, and that all other
deficiency findings would be considered uncontested.

I conducted an in-person hearing in Chicago, Illinois, on December 8 and 9, 2008. CMS
offered exhibits (CMS Exs.) 1 through 11, which were admitted. Petitioner offered
exhibits (P. Exs.) 8 through 31, which I admitted into evidence. Petitioner withdrew P.
Exs. | through 7. CMS elicited testimony from Arletha Henson-Walker, state agency
surveyor; and Mary Durand, state agency surveyor. Petitioner elicited testimony from
Frank Brazier, a maintenance supervisor employed by Petitioner; Kelly Bates, director of
social services, Deerbrook Care Centre, Joliet, Illinois; Sue Bessette, administrator
employed by Petitioner; Joshua Ryan Schott, certified nurse’s assistant employed by
Petitioner at the time of the March survey. On December 16, 2008, Petitioner arranged
for the deposition of Daniel M. Jurak, M.D., a physician at Petitioner’s facility, and was
subject to examination by Petitioner and CMS. A transcript of Dr. Jurak’s testimony was
prepared and received into evidence as P. Ex. 34.

Each party submitted a post hearing brief (CMS Brief and P. Brief, respectively) and a
reply brief (CMS Reply and P. Reply, respectively) and each party received a copy of the
hearing transcript (Tr.)

In the interest of judicial economy I do not address, and therefore make no findings or
conclusions regarding, the alleged violation of F323, 42 C.F.R. § 483.25(h) from the
April 1, 2008 survey. The violation discussed hereafter provides a sufficient basis for the
enforcement remedies proposed by CMS that I approve. See Beechwood Sanitarium,

' These matters were docketed under C-08-505 and C-08-749 and consolidated
under C-08-505.
3

DAB No. 1824, at 22 (2002). I do not consider the deficiencies not specifically
addressed as any part of the basis for the imposition of an enforcement remedy.

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

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

2. Whether the remedies imposed are reasonable.
B. Applicable Law and Regulations

Petitioner is considered a long-term care facility under the Social Security Act (Act) and
regulations promulgated by the Secretary of Health and Human Services (Secretary).

The statutory requirements for participation by a long-term care facility are found at
sections 1819 and 1919 of the Act, and at 42 C.F.R. Part 483. Sections 1819 and 1919 of
the Act vest the Secretary with authority to impose civil money penalties (CMPs) and
other remedies against a long-term care facility for failure to comply substantially with
participation requirements.

Pursuant to the Act, the Secretary has delegated to CMS the authority to impose various
remedies against a long-term care facility that is not complying substantially with federal
participation requirements. Facilities which participate in Medicare may be surveyed on
behalf of CMS by State survey agencies in order to ascertain whether the facilities are
complying with participation requirements. 42 C.F.R. §§ 488.10-488.28; 42 C.F.R.

§§ 488.300-488.335. Under Part 488, CMS may impose a per instance or per day CMP
against a long-term care facility when a State survey agency ascertains that the facility is
not complying substantially with participation requirements. 42 C.F.R. §§ 488.406,
488.408, 488.430. The regulations in 42 C.F.R. Part 488 also give CMS a number of
other remedies that can be imposed if a facility is not in compliance with Medicare
requirements.

Pursuant to 42 C.F.R. Part 488, CMS may terminate a long-term care facility’s provider
agreement when a survey agency concludes that the facility is not complying
substantially with federal participation requirements. CMS may also impose a number of
alternative enforcement remedies in lieu of or in addition to termination. 42 C.F.R.
4

§§ 488.406; 488.408; 488.430. In addition to termination and the alternative remedies
CMS is authorized to impose, pursuant to section 1819(h)(2)(D) of the Act and 42 C.F.R.
§ 488.417(b), CMS must impose the “mandatory” or “statutory” DPNA. Section
1819(h)(2)(D) requires the Secretary to deny Medicare payments for all new admissions
to a SNF, beginning 3 months after the date on which such facility is determined not to be
in substantial compliance with program participation requirements. The Secretary has
codified this requirement at 42 C.F.R. § 488.417(b).

The regulations specify that a CMP imposed against a facility can be either a per day
CMP for each day the facility is not in substantial compliance or a per instance CMP for
each instance that a facility is not in substantial compliance. 42 C.F.R. § 488.430(a).

The regulations specify that a CMP that is imposed against a facility on a per day basis
will fall into one of two broad ranges of penalties. 42 C.F.R. §§ 488.408, 488.438. The
upper range of CMP, of from $3050 per day to $10,000 per day, is reserved for
deficiencies that constitute immediate jeopardy to a facility’s residents, and in some
circumstances, for repeated deficiencies. 42 C.F.R. §§ 488.438(a)(1)(i), (d)(2). The
lower range of CMP, from $50 per day to $3000 per day, is reserved for deficiencies that
do not constitute immediate jeopardy, but either cause actual harm to residents, or cause
no actual harm, but have the potential for causing more than minimal harm. 42 C.F.R.

§ 488.438(a)(1)(ii). There is only a single range of $1000 to $10,000 for a per instance
CMP, which applies whether or not immediate jeopardy is present. 42 C.F.R.

§§ 488.408(d)(1)(iv); 488.438(a)(2).

The regulations define the term “substantial compliance” to mean “a level of compliance
with the requirements of participation such that any identified deficiencies pose no
greater risk to resident health or safety than the potential for causing minimal harm.” 42
C.F.R. § 488.301. Non-compliance that is immediate jeopardy is defined as “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.”
Id. The Act and regulations make a hearing before an administrative law judge (ALJ)
available to a long-term care facility against whom CMS has determined to impose a
CMP. Act, section 1128A(c)(2); 42 C.F.R. §§ 488.408(g); 498.3(b)(13). The hearing
before an ALJ is a de novo proceeding. Anesthesiologists Affiliated, et al, DAB CR65
(1990), aff’’d, 941 F2d. 678 (8th Cir. 1991).

A facility has a right to appeal a “certification of noncompliance leading to an
enforcement remedy.” 42 C.F.R. § 488.408(g)(1); see also 42 C.F.R. §§ 488.330(e) and
498.3. However, the choice of remedies by CMS or the factors CMS considered when
choosing remedies are not subject to review. 42 C.F.R. § 488.408(g)(2). A facility may
5

only challenge the scope and severity level of noncompliance found by CMS if a
successful challenge would affect the amount of the CMP that could be collected by CMS
or impact upon the facility’s nurse aide training program. 42 C.F.R. §§ 498.3(b)(14) and
(d)(10)(1). CMS's determination as to the level of noncompliance “must be upheld unless
it is clearly erroneous.” 42 C.F.R. § 498.60(c)(2). This includes CMS’s finding of
immediate jeopardy. Woodstock Care Center, DAB No. 1726, at 9, 38 (2000), aff'd,
Woodstock Care Center v. U.S. Dept. of Health & Human Services, 363 F.3d 583 (6th
Cir. 2003). The Departmental Appeals Board (the Board or DAB) has long held that the
net effect of the regulations is that a provider has no right to challenge the scope and
severity level assigned to a noncompliance finding, except in the situation where that
finding was the basis for an immediate jeopardy determination. See, e.g., Ridge Terrace,
DAB No. 1834 (2002); Koester Pavilion, DAB No. 1750 (2000). Review of a CMP by
an ALJ is governed by 42 C.F.R. § 488.438(e).

In a CMP case, CMS must make a prima facie case that the facility has failed to comply
substantially with participation requirements. To prevail, a long-term care facility must
overcome CMS's showing by a preponderance of the evidence. Hillman Rehabilitation
Center, DAB No. 1611 (1997); aff'd, Hillman Rehabilitation Center v. U. S. Dept. of
Health & Human Services, No. 98-3789 (GEB) (D.N.J. May 13, 1999).

C. Findings of Fact, Conclusions of Law, and Discussion

I make two findings of fact and conclusions of law to support this decision. I set them
forth below as separate headings in bold type, and then discuss each in detail.

1. Petitioner failed to comply substantially with the requirement in 42
C.E.R. § 483.25(c) (F314) that it protect its residents against the
development of pressure sores.

The regulation at issue here mandates that a resident who enters a skilled nursing facility
without pressure sores will not develop a pressure sore or sores unless the resident’s
clinical condition demonstrates that the development of a pressure sore was unavoidable.
42 C.F.R. § 483.25(c)(1). Additionally, it requires a facility to provide necessary
treatment and services to any resident having pressure sores, to promote healing, prevent
infection, and prevent new sores from developing. 42 C.F.R. § 483.25(c)(2).

CMS alleges in its March 17, 2008 statement of deficiency (SOD) that Petitioner failed to
protect Resident 3 against the development of pressure sores. Specifically, CMS alleges
that Petitioner: (1) failed to accurately assess pressure sores of Resident 3 upon her re-
6

admission to the facility; (2) failed to treat pressures sores as ordered by Resident 3’s
physician; and (3) failed to take the necessary steps to prevent Resident 3 from
developing stage III and stage IV pressure sores.

At the time of the survey, Resident 3 was a 95-year old woman with multiple ailments
including a history of cerebrovascular accident, osteoporosis, anemia, renal insufficiency,
and urinary tract infection. P. Ex. 8, at 3-5; CMS Ex. 6, at 83.

Resident 3 was originally admitted to Petitioner’s facility in 2003, and upon readmittance
from a local hospital in November of 2007, she had a decubitus ulcer on her coccyx and
left heel. Resident 3 also had a cast on her right leg due to surgery as a result of
osteoporosis. P. Ex. 34, at 9. CMS points out that facility records indicate that Resident
3 had no skin breakdown, but noted areas of blistering and reddening. CMS contends
that Petitioner’s notation was inaccurate because the blistered area should have been
assessed as a stage II pressure sore, and that this inaccuracy was caused by a failure of
Petitioner to assess Resident 3 adequately for pressure sores. CMS Br. 4-5.

The record shows that Resident 3’s physician ordered treatment for these ulcers. The
orders required a daily dry dressing, a cleansing of the coccyx wound with normal saline
solution, as well as an application of DuoDerm every three days as needed until healed.
P. Ex. 16; P. Ex. 34, at 12-13; CMS Ex. 6, at 95.

However, surveyors found that Petitioner’s staff failed to administer treatment as required
and ordered. CMS Ex.1, at 4-7. Specifically, on at least three occasions in November
(15, 17, and 18) Petitioner failed to change Resident 3’s dry dressing on her heel as
required by her physician’s orders. CMS Ex. 6, at 158. Similarly, Petitioner’s staff failed
to cleanse Resident 3’s pressure sore with normal saline solution and every three days
DuoDerm as required and ordered. Instead, Petitioner’s treatment records show that
facility staff failed to follow the physician’s explicit orders, allowing four days to elapse
between November 13 and 17, and six days to elapse between November 17 and 23,
before administering treatment as directed. CMS Ex. 6, at 158. On February 25, 2008,
Resident 3 died. CMS Ex. 6, at 20-24. A preliminary coroner’s report indicated that
Resident 3 had stage III and stage IV pressure sores. CMS Ex. 6, at 22; Tr. 66-67. CMS
has established a prima facie violation of 42 C.F.R. § 483.25(c).

Petitioner does not dispute the surveyor’s findings. However, Petitioner maintains that
the development of Resident 3’s pressure sores were unavoidable; that the pressure sores’
7

worsening was due to her extremely poor health; and that Resident 3’s decline was
inevitable. P. Br. 2-3. Petitioner further explains its argument as follows:

[The] presence of pressure sores is largely explained by the fact that
[Resident 3’s] body could not metabolize the food that it was taking in.
Moreover, [Resident 3] had poor circulation because of the fact that she had
no palpable pulses in her feet. The combination of poor nutrition, lack of
mobility, and poor circulation positively made it very easy for [Resident 3]
to develop pressure sores.

P. Br. 2.

Petitioner insists that it implemented a rigorous plan of care accompanied with
interventions in order to promote Resident 3’s healing, prevent infection, and prevent
new sores from occurring. These interventions included: (1) providing Resident 3 with a
pressure-relieving mattress; (2) placing a cushion in Resident 3’s wheelchair; (3) assuring
that Resident 3’s skin was clean and dry at all times; (4) encouraging Resident 3 to eat all
her food, consume fluids, and take vitamin supplements; (5) performing daily skin care
checks; and (6) applying topical antibiotic ointments. CMS Ex. 6, at 158; P. Ex. 34, at
18-19; Tr. 138-139.

Petitioner’s arguments are unavailing and I find that Petitioner failed to carry out
physician orders for the treatment of existing pressure sores which the physician deemed
important to promote healing and fight infection as required pursuant to 42 C.F.R.

§ 483.25(c)(2). I find that Petitioner suffered actual harm.

The record shows that Petitioner simply failed to adhere to Resident 3’s doctor’s orders.
Petitioner did not change the dry dressing every day on Resident 3’s right heel as
required by her doctor’s orders, and Petitioner did not cleanse Resident 3’s coccyx with
normal saline and DuoDerm every three days as her doctor’s orders had required. I note
that Petitioner on at least one occasion in its medical records and brief referred to the sore
on Resident 3’s heel upon admittance in November 2007 as a “‘scab” or “blister.” P. Br.
3. CMS has maintained from the beginning that Petitioner’s characterization of the sore
was inaccurate and that it should have been coded as a stage II pressure sore or ulcer.
CMS Br. 4. Despite Petitioner’s description of Resident 3’s sore, Petitioner does not
dispute and the record is clear that Resident 3 arrived at Petitioner’s facility in November
of 2007 with sores on her heel and coccyx. P. Ex. 34, at 9-10; P. Br. 2. Thus, since
Resident 3 arrived at Petitioner’s facility with pressure sores, the regulations at 42 C.F.R.
§ 483.25(c)(2) require Petitioner to provide the necessary treatment and services to
promote healing, prevent infection, and prevent new sores from developing.
8

The application of this regulation is well-established by decisions of various appellate
panels of the Board. Koester Pavilion, DAB No. 1750 (2000); Cross Creek Health Care
Center, DAB No. 1665 (1998). With respect to prevention and treatment of pressure
sores, the Board has concluded that a facility bears a duty to “go beyond merely what
seems reasonable to, instead, always furnish what is necessary to prevent new sores
unless clinically unavoidable, and to treat existing ones as needed.” Koester Pavilion,
DAB No. 1750, at 32.

Petitioner admits that on at least three days in November 2007 it failed to change
Resident 3’s dry dressing on her heel and on at least two occasions allowed four or more
days to elapse before cleansing Resident 3’s coccyx with normal saline and DuoDerm. P.
Reply 2-5. However, Petitioner argues essentially that it substantially complied with
Resident 3’s doctors orders and that, “CMS has attempted to label [Petitioner] has (sic) a
violator due to its failure to document and follow every physician order to a “T”.” P.
Reply 4. Petitioner further argues that its case is similar to Koester Pavilion, and that the
facts here are much more favorable to its legal position. In Koester Pavilion, the facility
properly prescribed footwear that was specifically designed to prevent pressure sores in
high risk situations. The Health Care Financing Administration (HCFA) — now CMS —
argued that the design of the boot caused the development of the pressure sore and
therefore the facility did not properly care for the patient’s pressure sores. The ALJ
disagreed with HCFA, finding that despite the use of the boot, the sore was clinically
unavoidable as a result of the disease process.

I agree with Petitioner that the regulations do not require a facility to be perfect in its
execution when providing care to its residents. However, a facility is obligated to
provide the necessary quality and quantity of care and services in order to meet a
resident’s needs. Kelsey Memorial Hospital, DAB CR583 (1999). Ina sickly, immobile,
95 year-old woman such as Resident 3, pressure sores may develop very quickly. A
pressure sore may greatly diminish a resident’s quality of life and may even be lethal.
Petitioner’s failure to follow her doctor’s explicit orders to provide the necessary dressing
changes and cleansing of Resident 3’s pressure sores on several occasions, as scheduled
and required by those orders, falls below the quality of care that the regulations require.

Moreover, Petitioner’s reliance on Koester Pavilion to support its position is misguided.
In Koester Pavilion the ALJ did in fact rule in favor of the facility, finding that the
resident’s sores were clinically unavoidable. However, in Koester Pavilion, the ALJ
specifically found that the facility took all appropriate measures to treat the resident’s
pressure sores, and despite these efforts pressure sores developed. Such was not the case
here, where Petitioner did not administer treatment as required and ordered, and thus
failed to deliver necessary treatment and services to promote healing, prevent infection,
and prevent new sores from developing. 42 C.F.R. § 483.25(c)(2).

9

Petitioner points out that Resident 3’s treating physician, Dr. Daniel Jurak agreed with
Petitioner’s assessment that because of her poor health, Resident 3’s pressure sores
worsened and that her decline was inevitable. Eventually, because of Petitioner’s
deteriorating physical condition, Dr. Jurak concluded that:

[Resident 3] did not improve and there did become a point where the
treatments seemed to be causing her more discomfort with trying to turn her
and give her dressing changes and those kinds of things, to the point where,
you know, I think the guardian eventually said that she just wanted her to
be continued on the comfort measures, and then we discussed about hospice
coming in to see her....

P. Ex. 34, at 20.

Petitioner’s argument is unpersuasive and Dr. Jurak’s testimony does not change my
conclusion. The regulations impose an identical duty of care on a facility with respect to
every resident regardless of physical condition. See Clermont Nursing and Convalescent
Center, DAB No. 1923 (2004). They require a facility to assume that no pressure sore is
inevitable or unavoidable. A facility must do its best to assure that a resident does not
develop a pressure sore or that an existing pressure sore does not worsen. Inevitability is
not a defense as Petitioner urges here, where a facility has failed to

discharge its regulatory obligations by failing to follow a doctor’s orders concerning the
treatment of that doctor’s patient. Inevitability may be a defense where a facility takes all
reasonable measures to protect a resident, and the resident’s sores develop or worsen
despite those measures. I have no reason to doubt Dr. Juraks’s sincerity when he testified
that he believed that Resident 3 was not likely to be helped much by the measures he
ordered, and that she was physically very compromised, but the fact is that the treatment
orders he gave were not followed, and neither he nor anyone else available to give
credible testimony in this case can say what might have happened, or not happened, if
those orders had been followed. Furthermore, as Resident 3’s treating physician, if Dr.
Jurak believed that the dress changes and cleansing of Resident 3’s pressure sores were
causing her more harm and pain than benefit, he could have simply changed his orders.
He did not, and the facility did not enjoy the option simply to ignore a physician’s
treatment order.

Remaining Tags

The parties stipulated that the scope of the hearing would be limited to evidence related
to the F314 and F323 tags, and that all other deficiency findings would be considered
uncontested. Because I have sustained CMS’s deficiency finding F314, 42 C.F.R.
10

§ 483.25(c), I will not discuss the remaining F323 deficiency tag. It is not necessary that
I make a finding concerning this additional alleged deficiency inasmuch as its presence or
absence will add nothing to my decision in this case. The applicable regulations
authorize imposition of a CMP if a provider is found to be out of substantial compliance
with even a single program requirement. 42 C.F.R. §§ 488.406, 488.408, 488.430.

Additionally, I have the discretion to exercise judicial economy and not discuss every
alleged deficiency. Beechwood Sanitarium, DAB No. 1824, at 22 (2002); Western Care
Management, DAB CR1020 (2003).

2. The amount of the CMP imposed by CMS is reasonable.

In determining the amount of the CMP, the following factors specified at 42 C.F.R.

§ 488.438(f) must be considered: (1) the facility’s history of non-compliance, including
repeated deficiencies; (2) the facility’s financial condition; (3) the seriousness of the
deficiencies as set forth at 42 C.F.R. § 488.404; and (4) the facility’s degree of
culpability.

The lower range of CMP, from $50 per day to $3000 per day, is reserved for deficiencies
that do not constitute immediate jeopardy, but either cause actual harm to residents, or
cause no actual harm, but have the potential for causing more than minimal harm. 42
CFR. § 488.438(a)(1)(ii).

CMS seeks to impose a CMP of $200 a day from March 17, 2008 through June 8, 2008,
for a total civil money penalty of $16,800.

Petitioner denied the existence of deficiencies at F314 and F323, but did not argue that
substantial compliance was achieved at any earlier date than alleged by CMS. However,
Petitioner argues with respect to the deficiency at F314, that its failure to follow Resident
3’s physician orders was an isolated incident; that its failure did not amount to actual
harm; and that the $200 per day CMP was excessive. P. Reply 9-10.

I disagree. The deficiency determination at F314 easily supports a $200 per day CMP
imposition. The record shows that Petitioner failed to follow treatment orders as required
and that Resident 3 developed stage III and stage IV pressure sores while at Petitioner’s
facility, thus a determination that she suffered actual harm is warranted. There was no

compelling evidence presented that persuaded me that Petitioner was not culpable, nor
were there facts that indicated that its culpability is in any way diminished which would
warrant the reduction of the CMP amount in this case. The $200 per day CMP is
reasonable since it is in the lower range of penalties for deficiencies that do not constitute
ll

immediate jeopardy but involved actual harm or caused no harm but have the potential
for more than minimal harm.

Neither party has contended that the penalty amount should be affected by Petitioner’s
compliance history or financial condition. There is no evidence showing that Petitioner
has a history of noncompliance other than during this survey cycle. Petitioner has not
provided any evidence to show that its financial condition precludes it from paying the
proposed CMP totaling $16,800.

Ii. Conclusion

For the foregoing reasons, I conclude that there is a basis for the imposition of a CMP. I
further find that a CMP of $200 per day for 84 days from March 17, 2008 through June 8,
2008, for a total CMP of $16,800, is reasonable.

/s/
Richard J. Smith
Administrative Law Judge


Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

In the Case of: )
)
Charles J. Anselmo, ) Date: July 22, 2009

)
Petitioner, )
)

-V.- ) Docket No. C-09-311

) Decision No. CR1979
The Inspector General. )
)

DECISION

Petitioner, Charles J. Anselmo, asks review of the Inspector General’s (I.G.’s)
determination to exclude him for ten years from participation in Medicare, Medicaid, and
all federal health care programs under section 1128(a)(3) of the Social Security Act. The
1G. has moved for dismissal, arguing that the appeal is untimely.’ I agree and dismiss
Petitioner’s appeal.

Petitioner’s hearing request must be dismissed pursuant to
42 C.F.R. § 1005.2(e)(1) because it was not timely filed.”

Petitioner was a pharmacist licensed in the State of Texas. On August 14, 2001, he was
convicted of a felony, aiding and abetting health care fraud, in violation of 18 U.S.C.
sections 1347 and 2. CMS Ex. 3.

In a letter dated May 30, 2003, the LG. advised Petitioner that, based on his felony
conviction, he was excluded from participation in Medicare, Medicaid, and all federal
health care programs for a period of 10 years. CMS Ex. 1, at 37. With the notice letter,

' The L.G. has filed its motion to dismiss, accompanied by five exhibits (1.G. Exs.
1-5) and two attachments. Petitioner filed a response to the I.G.’s motion, and the 1.G.
filed a reply.

> I make this one finding of fact/conclusion of law.
the I.G. sent Petitioner an explanation of his appeal rights: he was entitled to a hearing
before an administrative law judge if he filed a written request for review within sixty
days after receipt of the notice. CMS Ex. 1, at 39. Petitioner filed a hearing request on
March 11, 2009, almost six years after the notice was sent.

Petitioner does not dispute his timely receipt of the notice, but claims that he did not
appeal timely because he misunderstood the terms of his criminal plea agreement,
mistakenly thinking that it precluded him from appealing the I.G.’s exclusion. (In reality,
it precluded him only from appealing his criminal conviction). Petitioner also asserts
that, at the time he received the notice, he reasonably anticipated that he could find
employment as a pharmacist, notwithstanding the exclusion. But, because Medicare
changed its reimbursement practices, pharmacies that might then have employed him
would no longer do so. Finally, Petitioner complains about the I.G.’s delay in imposing
his exclusion.

The regulations governing these proceedings grant me virtually no discretion. An
aggrieved party must request a hearing within sixty days after receiving notice of the
exclusion. 42 C.F.R. § 1001.2007(b). The date of receipt is presumed to be five days
after the date of the notice unless there is a reasonable showing to the contrary. 42 C.F.R.
§ 1005.2(c). The regulations include no good-cause exceptions for untimely filing,
providing that the ALJ wil/ dismiss a hearing request that is not filed in a timely manner.
42 C.F.R. § 1005.2(e)(1); John Maiorano, R. Ph. v. Thompson, No. 04-2279, slip op. at 6,
2008 WL 304899, at *3 (D.N.J. Feb. 1, 2008).

I therefore dismiss Petitioner’s request for a hearing pursuant to 42 C.F.R. § 1005.2(e)(1).

/s/
Carolyn Cozad Hughes
Administrative Law Judge


Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

In the Case of:

Lompoc Healthcare District
Convalescent Care Center,
(CCN: 05-5256),

Date: July 22, 2009

Petitioner,

Docket No. C-08-568
Decision No. CR1978

-V.-

Centers for Medicare & Medicaid
Services.

Seesaw ES ES SS SES SD

DECISION

I sustain the determination of the Centers for Medicare & Medicaid Services
(CMS) to impose a per-instance civil money penalty of $3,000 against Petitioner,
Lompoc Healthcare District Convalescent Care Center. I also sustain CMS’s
determination to impose a denial of payment for new Medicare admissions against
Petitioner for a period that began on May 22, 2008 and which ran through June 3,
2008.

I. Background

Petitioner is a skilled nursing facility doing business in the State of California. It
participates in Medicare. Its participation in that program is governed by sections
1819 and 1866 of the Social Security Act and by implementing regulations at 42
C.F.R. Parts 483 and 488.

CMS determined to impose against Petitioner the remedies that I describe in the
opening paragraph of this decision. CMS based its determination on
noncompliance findings made at a survey of Petitioner’s facility that was
completed on April 11, 2008 (April survey). Petitioner requested a hearing and
the case was assigned to me for a hearing and a decision. I scheduled an in-person
hearing. However, the parties agreed that the case could be heard and decided
based on their written submissions.

CMS filed 40 proposed exhibits which it identified as CMS Ex. 1 —- CMS Ex. 40.
Petitioner filed 24 proposed exhibits which it identified as P. Ex. 1 — P. Ex. 24.
CMS moved that I exclude portions of some of Petitioner’s exhibits. I denied that
motion. I receive into evidence CMS Ex. 1 — CMS Ex. 40 and P. Ex. 1 — P. Ex.
24,

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

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

2. CMS’s remedy determinations are reasonable.

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.

The noncompliance findings of the April survey include allegations that Petitioner
failed to comply substantially with several Medicare participation requirements.
In this decision I address one of those findings, Petitioner’s alleged failure to
comply with the requirements of 42 C.F.R. § 483.25(h). As I discuss below the
weight of the evidence strongly supports the noncompliance finding. Petitioner’s
noncompliance with this regulatory requirement is sufficient to sustain CMS’s
remedy determinations. Therefore, it is unnecessary that I address the other
noncompliance findings.

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

A skilled nursing facility must ensure that each of its residents receives adequate
supervision and assistance devices to prevent accidents. 42 C.F.R. § 483.25(h)(2).
This requirement imposes several duties on a facility. First, the facility must
assess each of its residents in order to identify every known or knowable risk of
accidents that the resident is at risk of encountering. Second, the facility must plan
the resident’s care in accordance with its assessment in order to assure that every
reasonable measure is taken to protect the resident. Finally, the facility must
implement its care plan so as to provide actual protection to the resident.

The process of caring for a resident is dynamic as are the duties owed by a facility
to its residents. A resident’s condition is rarely static and the facility’s knowledge
of the resident’s condition and the hazards that he or she may encounter evolves
with the passage of time. A facility must continuously readjust its assessment of
each resident’s risks and problems as the staff learns more about the resident’s
condition or the resident’s condition evolves. New or amended assessments must
be translated into revised care plans and these must be implemented.

CMS’s allegations of noncompliance focus on the care that Petitioner gave to two
residents who are identified in the April survey report as Residents #s 14 and 7.
The facts pertaining to these two residents differ but CMS’s core allegations
concerning each of them are essentially identical. CMS contends that Petitioner
was remiss in assessing, planning care for, and implementing needed supervision
and assistance for each of these residents. It asserts that each of these residents is
an individual who is at high risk for sustaining falls. CMS argues that various
incidents established clearly that the assessments and interventions that Petitioner
had developed were not working adequately to protect each of these residents.
According to CMS, Petitioner’s staff failed to take new information into account
to adjust the assessments they had made of each resident’s condition and to
develop and implement new interventions to replace interventions that were not
protecting each resident adequately.

The weight of the evidence strongly supports CMS’s noncompliance allegations.
The evidence establishes a persistent failure by Petitioner’s staff to make
meaningful assessments of residents’ accident risks or to implement effective
interventions to protect the residents even in the face of facts that should have
caused the staff to act urgently.

Resident # 14 was aged 91 as of the April survey. She had been assessed by
Petitioner’s staff as being at high risk for sustaining falls. CMS Ex. 16, at 16. She
had suffered a stroke and her physical problems included an impaired gait. Jd., at
99.

The resident also suffered from cognitive and memory problems consistent with
Alzheimer’s disease. CMS Ex. 16, at 98. The staff assessed her as having both
short and long-term memory problems and concluded that the resident’s cognitive
skills were moderately impaired for daily decision making. /d., at 180, 184, 189.
She had episodes of disorganized speech and was only sometimes capable of
understanding others. /d., at 177-193. In May 2007, Petitioner’s staff concluded
that the resident’s cognitive loss was so severe that she didn’t recognize the staff
nor could she identify the location of her room. /d., at 52. The resident’s son told
the staff that the resident displayed confusion, anxiety, nocturnal agitation,
memory lapses, and episodes of paranoia. P. Ex. 7, at 17.

Resident # 14 sustained multiple falls while residing at Petitioner’s facility. These
falls had common features. Nearly all of these falls occurred while the resident
was in the vicinity of her bathroom or attempting to use it, and all of them

occurred after 6:00 p.m. and before 8:00 a.m. They included falls sustained on
October 22, 2007, November 26, 2007, January 9, 2008, January 15, 2008, and
March 29, 2008. CMS Ex. 16, at 11-15. This series of falls culminated with a fall
that the resident sustained on March 30, 2008. On that occasion, the resident fell
again while attempting to use her bathroom and she fractured her hip. /d., at 10.

There was a pattern to the falls that put Petitioner’s staff on notice that Resident

# 14 was at very high risk for falling when she attempted to use her bathroom
during the night and early in the morning. The resident’s falls history and the
common circumstances of these falls mandated that Petitioner address the issue by
assessing the resident to determine exactly what problems she faced when she
attempted to use the bathroom at night and in the early morning hours and to
develop interventions to attack the problems that the staff identified.

On November 21, 2007, Petitioner’s staff revised Resident # 14’s care plan in
apparent response to the Resident’s October 22, 2007 fall. CMS Ex. 16, at 44.
The intervention that was directed as of that date was to remind the resident to use
her call light, especially at night, and to assure the resident that she would not
bother anyone if she used the light. /d. After the resident’s November 26, 2007
fall, her care plan was revised to tell Petitioner’s staff to remind Resident # 14 that
she should use a walker when she ambulated. Jd. The plan was again revised on
February 15, 2008. On that date staff was instructed to use “facility toileting
protocol” to ask the resident if she needed to use the bathroom, and to move the
resident’s personal alarm to her upper back where it would be out of sight, in an
apparent effort to minimize the chances that the resident would deactivate the
alarm on her own. Id.

These minimal interventions were obviously unsuccessful. Staff should have
known that they would be inadequate. It should have been evident to Petitioner’s
staff that it would likely have been futile to instruct the resident to use her call
light when she needed to go to the bathroom or to use her walker when she
ambulated. Not only did these measures not work — as is demonstrated by the
resident’s repeated falls — but there was scant likelihood that they would work
given the resident’s obvious dementia. It is simply not reasonable to conclude that

a resident who was so mentally compromised could be protected adequately by
verbal reminders.

Moreover, if the staff thought that the resident might be protected adequately with
verbal reinforcement, they had at least the duty to make a thorough assessment of
the resident in order to determine whether such reinforcement actually would
work. There is nothing in the resident’s treatment record to suggest that the staff
did that.

What is also evident from the resident’s record is that Petitioner’s staff neither
considered nor attempted other measures that might have protected Resident # 14
better. For example, the staff never attempted to put the resident on a regular
schedule of nighttime bathroom visits. Nor did it implement enhanced observation
or surveillance of the resident. See CMS Ex. 37, at 26-27

The facility toileting protocol that is referred to in the February 15, 2008 revision
to the resident’s care plan would have had had the staff ask the resident at intervals
whether she needed to use the bathroom. Petitioner’s director of nursing told one
of the surveyors who participated in the April survey that this intervention was not
implemented because the staff concluded that the resident would be
uncooperative. CMS Ex. 16, at 5. But, there is no documentation in the resident’s
record showing that the staff attempted this intervention and were rebuffed by the
resident. And, if the intervention was attempted and failed, the record is devoid of
any assessment to determine what other possible interventions might have
succeeded in lieu of implementing the facility’s toileting protocol.

Resident # 7, like Resident # 14, was an individual who had cognitive and memory
loss and who was at risk for falling. She was admitted to Petitioner’s facility on
August 14, 2007. CMS Ex. 9, at 1. On admission the staff noted that the resident
had a history of falls and that she wore a waist restraint. Jd., at 7-8. The staff
assessed the resident as having very poor safety awareness and judgment due to
her dementia. P. Ex. 4, at 20.

The resident wore the waist restraint throughout the period beginning with her
admission and continuing up through the April survey.' The waist restraint

consisted of a belt that was attached to the resident’s wheelchair and which, in
theory, the resident could not release on her own initiative. CMS Ex. 9, at 11.

' The waist restraint was changed on April 23, 2008 to a belt that tied behind the
resident’s wheelchair. P. Ex. 4, at 43. This intervention occurred after the April
survey.
However, the waist restraint clearly failed to protect Resident # 7 against
sustaining falls. On November 27, 2007, the resident fell and was found lying on
the floor of her room. CMS Ex. 9, at 4. Petitioner’s staff concluded that the
resident had “released her waistbelt.” Jd. The resident’s care plan was amended
on December 5, 2007 to show that a “blue mat” had been placed on the floor next
to the resident’s bed, evidently as an intervention designed to cushion the resident
from a potential fall from the bed to the floor. /d., at 16. Additionally, a personal
alarm was added to the resident’s wheelchair effective February 29, 2008. Id.
But, there is nothing in the care plan addressing the potential problems arising
from the resident’s apparent ability to release her waist belt. There is no record
that the staff conducted a thorough investigation into how the resident could have
released her waist belt or the exact circumstances of the resident’s fall. Nor is
there any evidence showing that the staff engaged in intensive planning to prevent
a future fall from occurring under similar circumstances.

It is not surprising that the resident fell again on April 4, 2008 given the staff’s
failure to thoroughly assess the reasons for the resident’s first fall and to plan her
care accordingly. CMS Ex. 9, at 13; P. Ex. 4, at 39. On this occasion Petitioner’s
staff found Resident # 7 sitting on the floor in her room. The staff concluded that
the resident had removed her waist belt and had attempted to transfer herself into
her bed. Jd. As was the case with the November 2007 fall, the resident’s care
record is devoid of evidence to show that Petitioner’s staff made a comprehensive
investigation of the fall’s causes. The staff finally decided, on April 23, 2008, to
change the type of waist belt that the resident wore to a design that fastened
behind her and which she could not self-release. P. Ex. 4, at 43. However, that
decision was made about three weeks after the resident sustained her fall and after
completion of the April survey.

I have considered Petitioner’s allegations and arguments concerning the care that
it gave Residents #s 14 and 7 and I find them to be unpersuasive.

Petitioner’s principal argument concerning the care that it provided to Resident

# 14 is that the care was consistent with the resident’s expressed wishes. That,
according to Petitioner, excused it from responsibility for the many falls that the
resident sustained while under Petitioner’s care. The premise for this argument is
that Resident # 14 was far from being significantly demented. Petitioner contends
that CMS demeans the resident by referring to her as being confused and
demented. Petitioner characterizes this resident as only “slightly confused, but
capable of independent decision-making, observation and socializing with her
friends.” Petitioner’s closing brief at 19. It asserts that the resident’s alleged
resistance to supervision and assistance was a “conscious decision” that should not
“have been overridden by restraining her against her will, or against the wishes of
her family.” Jd.
Petitioner’s contentions fail in two respects. First, Petitioner mischaracterizes the
true state of the resident’s mental condition. Petitioner’s records do not show the
resident to have been only slightly cognitively impaired. To the contrary,
Petitioner’s records show that the resident suffered from fairly profound dementia
typical of Alzheimer’s disease. CMS Ex. 16, at 98. It is not CMS that first
identified Resident # 14 as being confused and demented. Petitioner’s staff
assessed the resident as being so confused that she could not identify her own
room or members of Petitioner’s staff. CMS Ex. 16, at 52. And, it was
Petitioner’s staff who concluded that Resident # 14 had both short and long-term
memory problems and who concluded that the resident’s cognitive skills were
moderately impaired for daily decision making. Jd., at 180, 184, 189.

Thus, Petitioner’s own records refute Petitioner’s argument that Resident # 14 was
sufficiently lucid that she could intelligently refuse the care options that Petitioner
offered to her. Moreover, the record is devoid of evidence that Petitioner actually
assessed the resident to determine whether she was capable of refusing care or
profiting from the interventions that Petitioner’s staff offered. For example,
reminding the resident to use her call light when she needed assistance was a
principal intervention that Petitioner’s staff developed and, apparently, relied on.
In spite of that Petitioner has not pointed to a single assessment of the resident that
shows that she was capable of remembering to use her call light. Nor does the
record contain documents proving that the staff developed appropriate
interventions (such as a nighttime toileting plan or closer surveillance during the
night), offered them to the resident, and were rebuffed by her.

Second, Petitioner posits the care options that were available for Resident # 14 as
being a choice between not providing greater assistance and supervision to the
resident and restraining her against her will. To this end, Petitioner offers the
testimony of its director of nursing who asserts that she decided to discontinue the
resident’s waist restraint after discussing the matter with the resident and her
family. P. Ex. 14, at 7.7

> The director of nursing also asserts that she had many conversations with
Resident # 14 in which she warned her about the risks that came with attempts by
the resident to transfer herself or to walk without assistance. Jd. Petitioner
evidently offers this testimony to show that its staff diligently attempted to use
verbal advice in order to protect the resident. However, even the best advice loses
its value if the resident is unable to remember or understand it.
This argument presents a false choice. CMS has not argued that Petitioner needed
to restrain Resident # 14 against her will in order to protect her. There were
options falling far short of restraints — for example, checking on the resident
periodically and simply having her use the bathroom at regular intervals — that
Petitioner could have tried but never attempted.

Petitioner contends that the two falls sustained by Resident # 7 “resulted from her
(or her son’s) releasing the resident’s waist restraint. .. .” Petitioner’s closing
brief at 17. From this assertion it seems to suggest that its staff should be absolved
from responsibility for protecting the resident due to the resident’s son’s alleged
acts. It also contends that its staff adequately addressed the resident’s falls
through discussions with the resident’s family and by planning the resident’s care.
Petitioner’s closing brief at 17. Additionally, Petitioner asserts that it addressed
the resident’s second fall in April 2008 by giving the resident a waist restraint with
loops which she could not untie and a wheelchair with anti-tip bars and footrests.
Id.

Petitioner identified nothing in the resident’s treatment record which supports its
theory of how Resident # 7 sustained her falls. The assertion that the resident’s
son released her waist belt is belied by Petitioner’s staff’s contemporaneous notes
which do not mention a cause for the resident’s falls other than the resident
releasing the waist belt on her own volition. CMS Ex. 9, at 4, 13. The evening
shift coordinator at Petitioner’s facility, who testified on behalf of Petitioner,
averred that on the occasion of the April 2008 fall the resident released herself
from her waist belt. P. Ex. 19, at 3.

Petitioner’s present speculation about how Resident # 7 fell simply underscores
the reality that its staff never conducted an investigation of either fall that
pinpointed its precise cause. The record is singularly devoid of evidence that the
staff comprehensively addressed either of Resident # 7’s falls. As I discuss above,
the care planning that Petitioner did for Resident # 7 in the wake of each of the
resident’s falls is woefully lacking in any comprehensive analysis of the cause of
the resident’s falls and how to prevent future falls.

Furthermore, Petitioner was not relieved from its obligation to protect Resident #7
by the possibility that the resident’s son may have released her belt on occasion. If
Petitioner’s staff knew that to be true, that knowledge imposed on them the
obligation to plan the resident’s care accordingly. But, there is nothing in the
resident’s care plans which shows that the staff addressed this issue aside from a
single entry on June 26, 2007:
Son has been informed not to remove waist belt, he may forget.

CMS Ex. 9, at 12. That notation was made more than three months prior to the
resident’s first fall in November 2007. The plan was not updated after either that
fall or the subsequent fall in April 2008 to show additional communications with
the resident’s son. Nor does the plan contain any analysis of how to assure that
the son did not release his mother’s waist restraint.

Petitioner avers that it addressed Resident # 7’s falls through care planning with
the resident’s family. It contends that it “actively designed care plans to prevent
Resident 7 from falling” in accordance with its own internal guidelines and
applicable regulations. Petitioner’s closing brief at 17. I find this assertion to be
unpersuasive. To be sure, Petitioner developed care plans for Resident #7. But,
these plans could not have systematically addressed the risks faced by the resident
because Petitioner’s staff never really pinpointed those risks.

2. CMS’s remedy determinations are reasonable.

CMS determined to impose two remedies to address Petitioner’s noncompliance
consisting of a $3,000 per-instance civil money penalty and a denial of payment
for new admissions for each day of a period that began on May 22, 2008 and
which ran through June 3, 2008. I find these remedies to be reasonable.

Per-instance civil money penalties may be imposed by CMS for each instance of
noncompliance with regulatory requirements and may fall within a range of
between $1,000 and $10,000 per day. 42 C.F.R. § 488.438(a)(2). The exact
amount of a penalty within this range depends on evidence relating to regulatory
factors that are set forth at 42 C.F.R. §§ 488.438(f)(1) — (4) and 488.404
(incorporated by reference into 42 C.F.R. § 488.438(f)(3)). These factors include
the seriousness of a facility’s noncompliance, its compliance history, its
culpability, and its financial condition.

The civil money penalty that CMS determined to impose against Petitioner is
modest when considered in the context of the permissible range of such penalties
and minute when measured against the duration of Petitioner’s noncompliance.
CMS could have opted to impose civil money penalties of up to $3,000 per day
against Petitioner for its noncompliance. 42 C.F.R. § 488.438(a)(1)(ii). Such
noncompliance clearly extended over a period of at least several weeks if not
longer.
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I find the penalty amount to be well-justified by the seriousness of Petitioner’s
noncompliance. Petitioner’s staff failed adequately to assess and document the
risks encountered by two of its residents. It failed to plan their care in a careful
and meaningful way. And, it failed to implement interventions that might have
protected the residents. That was a very serious breach of Petitioner’s duty and it
left these residents vulnerable to harm.

Petitioner has provided no argument or evidence that would justify reduction of
the penalty amount. Indeed, Petitioner failed to address the issue of penalty
amount in either its opening or closing brief.

CMS may impose denial of payment for new admissions, as a matter of discretion,
whenever a facility is not in compliance with Medicare participation requirements.
42 C.F.R. § 488.415(a). Petitioner has not made any arguments challenging
CMS’s authority to impose the remedy in this case. Therefore, I sustain it.

/s/
Steven T. Kessel
Administrative Law Judge