Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

In the Case of: )
)
Transitional Health Services ) Date: August 25, 2008

of Fremont (CCN: 23-5176), )
)
Petitioner, )
)

-Vv.- ) Docket No. C-07-730

) Decision No. CR1833
Centers for Medicare & Medicaid )
Services. )
)

DECISION

Petitioner, Transitional Health Services of Fremont (Petitioner or facility), is a long term
care facility located in Fremont, Michigan, that is certified to participate in the Medicare
program as a provider of services. Here, Petitioner appeals CMS’s determinations that,
from July 20 through November 15, 2007, it was not in substantial compliance with
Medicare requirements, and that on July 20, 2007, its deficiencies posed immediate
jeopardy to resident health and safety. For this alleged noncompliance, CMS has
imposed civil money penalties (CMPs) of $5500 per day for the one day of immediate
jeopardy, plus $250 per day for 55 days (July 21 through September 13, 2007), and $400
per day for 63 days (September 14 through November 15, 2007) of substantial
noncompliance that was not immediate jeopardy (total CMP: $44,450).

For the reasons set forth below, I find that from July 20 through November 15, 2007, the
facility was not in substantial compliance with Medicare requirements, and that on July
20, 2007, its deficiencies posed immediate jeopardy to resident health and safety. I find
the CMPs reasonable.

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
(Secretary) to promulgate regulations implementing the statutory provisions. Act, § 1819.
The Secretary’s regulations are found at 42 C.F.R. Part 483. To participate in the
2

Medicare program, a nursing facility must maintain substantial compliance with program
requirements. To be in substantial compliance, a facility’s deficiencies may pose no
greater risk to resident health and safety than “the potential for causing minimal harm.”
42 C.F.R. § 488.301. 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 ofa facility’s noncompliance —
which includes its immediate jeopardy finding — must be upheld unless it is “clearly
erroneous.” 42 C.F.R. § 498.60(c).

The Secretary contracts with state survey agencies to conduct periodic surveys to
determine whether skilled nursing facilities are in substantial compliance with program
participation requirements. Act, § 1864(a); 42 C.F.R. § 488.20. The regulations require
that each facility be surveyed once every 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, the facility seems to have a troubled compliance history. On June 1, 2007,
surveyors from the Michigan Department of Community Health (State Agency) went to
the facility to investigate a complaint and found, among other problems, a pattern of
sexual and physical abuse which the facility had neither investigated nor reported. CMS
Ex. 1.

Thereafter, a July 19, 2007 Life Safety Code (LSC) Survey found substantial
noncompliance with LSC requirements.

From July 17 — 20, 2007, surveyors returned to conduct the facility’s annual
recertification and licensure survey. The State Agency again concluded that the facility
was not in substantial compliance with federal requirements for nursing homes
participating in the Medicare program. Specifically, it did not meet the following federal
requirements:

. 42 C.F.R. § 483.15(h)(2) (Tag F253 — housekeeping/maintenance) at
an “E” level of scope and severity (pattern of noncompliance that
causes no actual harm with the potential for more than minimal
harm);

. 42 C.F.R. § 483.25 (Tag F309 — quality of care) at a “J” level of scope and
severity (isolated instance of noncompliance that poses immediate jeopardy
to resident health and safety);

. 42 C.F.R. § 483.25(c) (Tag F314 — pressure sores) at a “G” level of scope
and severity (isolated instance of noncompliance that causes actual harm
that is not immediate jeopardy);
3

. 42 C.F.R. § 483.25(h)(2) (Tag F324 — accidents) at an “E” level of
scope and severity;

. 42 C.F.R. § 483.25(i)(1) (Tag F325 — nutrition) at a “D” level of
scope and severity (isolated instance of noncompliance that causes
no actual harm with the potential for more than minimal harm);

. 42 C.F.R. § 483.25(1) (Tag F329 — unnecessary drugs) at an “E”
level of scope and severity;

. 42 C.F.R. § 483.60(a) and (b) (Tag F425 — pharmacy services) at a
“D” level of scope and severity; and

. 42 C.F.R. § 483.60(b), (d), and (e) (Tag F431 — pharmacy services)
at a “D” level of scope and severity.

CMS Ex. 3.

On September 14, 2007, the surveyors revisited the facility, and determined that its
substantial noncompliance continued, citing G level deficiencies under 42 C.F.R.
§ 483.25 (quality of care — accidents and pressure sores). CMS Ex. 4.

CMS agrees with the State Agency conclusions and, among other remedies, has imposed
CMPs of $5500 for one day of immediate jeopardy (July 20, 2007) and $250 per day for
the 55 days (July 21 through September 13), and $400 per day for the 63 days (September
14 through November 15, 2007) of substantial noncompliance that is not immediate
jeopardy. ($5550 + $13,750 + $25,200 = $44,450 total CMP). CMS Exs. 8, 11.

CMS later determined that the facility had achieved substantial compliance as of
November 16, 2007. CMS Ex. 11.

Petitioner here appeals the July 20 and September 14 survey findings. See Hearing
Request; Order, at 1 (March 25, 2008). It does not contest the June 1 complaint
investigation findings nor the July 19 LSC findings, so the CMS determinations with
respect to those surveys are final and binding. 42 C.F.R. § 498.20(b).'

' Although the record is a bit murky, it appears that, following an August 23, 2007
LSC re-visit survey, the State Agency determined that the facility had corrected its LSC
deficiencies as of August 15. CMS Exs. 2, 9; CMS Op. Br. at 3. CMS accurately points
out that, based on this undisputed noncompliance, it was therefore authorized to impose
penalties until August 15, without regard to the subsequent, disputed survey findings.
4

Responding to my order of October 5, 2007, the parties filed their opening briefs (CMS
Op. Br. and P. Op. Br.) and submissions. CMS offered 83 exhibits, but, during a March
20, 2008 prehearing conference, withdrew CMS Exhibits (Exs.) 12 and 13. In the
absence of any objection, I have admitted into the record CMS Exs. 1-11 and 14-83.
Petitioner offered 18 exhibits into evidence. CMS objected to portions of P. Exs. 1, 11,
and 18, which include unsworn statements from various individuals. While the
documents in question may be entitled to little weight, I found that they were neither
irrelevant nor immaterial, and admitted them. Order, at 2 (March 25, 2008); 42 C.F.R.
§ 498.60(b)(1).

Among its submissions, Petitioner included a list of proposed witnesses, but it failed to
submit any written declarations, as explicitly required by my initial prehearing order.
Acknowledgment and Initial Prehearing Order § 4 (“A party must exchange as a proposed
exhibit the complete written direct testimony of any proposed witness.” Emphasis
added). I therefore ruled that I would not allow Petitioner’s witnesses to testify at the in-
person hearing. Order, at 2 (March 25, 2008); see Acknowledgment and Initial
Prehearing Order 11 (“I may impose sanctions pursuant to section 1128A(c)(4) of the ..
. Act for a party’s failure to comply with any order including this order.”) (October 5,
2007); see Kenton Healthcare, LLC, DAB No. 2186, at 29 (2008) (Where witness failed
to appear for cross-examination, it was reasonable and within the ALJ’s discretion to
strike the witness’s written direct testimony rather than re-convening the hearing at a later
date); Lutheran Home at Trinity Oaks, DAB No. 2111, at 25, n.15 (2007) (ALJ may strike
testimony based on party’s failure to comply with prehearing order). I subsequently
denied both Petitioner’s motion to file its declarations as late-filed exhibits and its request
for reconsideration, finding that Petitioner had not shown good cause for late filing.
Order, at 2 (March 25, 2008); Ruling (April 3, 2008).

By letter dated April 29, 2008, Petitioner declined to cross-examine any of CMS’s
witnesses, so the scheduled hearing was cancelled. See, Order Cancelling Hearing and
Setting Briefing Schedule (April 30, 2008). The parties then filed closing briefs (CMS
Cl. Br. and P. Cl. Br.).

> A purpose of the pre-hearing order is to obtain early and full disclosure by both
parties, leading to the expeditious (and correct) resolution of the case. Here, not only did
Petitioner fail to submit any written declarations as ordered, its initial brief cites to no
evidence in support of its arguments. Only in its closing brief does Petitioner actually cite
to any evidence in the record. The prehearing order also explicitly states that “a
prehearing brief must contain any argument that a party intends to make.... I may
exclude an argument and evidence that relates to such argument if the party fails to
address it in its prehearing brief.” Acknowledgment and Prehearing Order § 7 (October 5,
2007). CMS might legitimately have moved for the exclusion of arguments and citations
to evidence that were mentioned for the first time in Petitioner’s closing brief. Compare,
e.g., P. Op. Br. at 4-5 with P. Cl. Br. at 5-10.
II. Issues

. Whether, from July 20 through November 15, 2007, the facility was in substantial
compliance with Medicare requirements;

. If the facility was not in substantial compliance on July 20, 2007, did its
deficiencies then pose immediate jeopardy to resident health and safety; and

. Except to argue that it was in compliance so no penalties should have been
imposed, Petitioner has not raised any arguments concerning the reasonableness of
the CMPs. I nevertheless conclude that the CMPs are reasonable.

III. Discussion

A, From July 20, 2007, through November 15, 2007, the
facility was not in substantial compliance with the program
participation requirement set forth at 42 C.F.R. § 483.25.

1. The facility abdicated its responsibility to
monitor the safety and effectiveness of its
residents’ anti-coagulant medications.

Under the Act and “quality of care” regulation, each resident must receive and the facility
must provide the necessary care and services to attain or maintain the highest practicable
physical, mental, and psychosocial well-being, in accordance with the resident’s
comprehensive assessment and plan of care. Act, § 1819(b); 42 C.F.R. § 483.25. The
regulation imposes on facilities an affirmative duty designed to achieve favorable
outcomes “to the highest practicable degree.” Windsor Health Care Center, DAB No.
1902, at 16-17 (2003); Woodstock Care Center, DAB No. 1726, at 25-30.

Three facility residents, identified as R15, R18, and R19, were receiving the anti-
coagulant drug, Coumadin, at the time of the July survey. Anti-coagulant drugs help to
inhibit the formation of blood clots, and are often prescribed to individuals who have
experienced inappropriate blood clotting, such as those who have had heart attacks,
strokes, or deep vein thrombosis. Dosages are individualized based on the patient’s

> My findings of fact and conclusions of law are set forth, in italics and bold, in
the discussion captions.
6

PT/INR (prothrombin time/international normalized ration) response to the drug. CMS
Ex. 59; CMS Ex. 14, at 2 (Kralka Decl. § 9); CMS Ex. 22, at 1-2 (Miller Decl. § 7).

Coumadin blood levels must be monitored carefully to assure that they are within a safe
and therapeutic range. If the levels are too high, the resident risks bleeding
complications; if the levels are too low, stroke could result. CMS Ex. 14, at 2 (Kralka
Decl. § 11). This need for careful monitoring is even more pronounced when the resident
is prescribed additional medications since Coumadin interacts with many other drugs in
dangerous, even fatal, ways. Antibiotics are particularly problematic because they can
increase Coumadin’s anti-coagulant effect. Thus, even greater care must be taken when
antibiotics are administered to an elderly patient on Coumadin. CMS Ex. 77, at 6.

The question here is what, if any, responsibility did the facility have to ensure that its
residents’ blood levels were monitored appropriately.

CMS is highly critical of the facility’s performance in this regard. The facility apparently
had no written policy in place that addressed assessing or monitoring residents who were
taking Coumadin. In practice, it seems that the facility itself took little, if any,
responsibility for monitoring the PT/INR of its residents — even those who were at
exceptionally high risk of bleeding complications. According to CMS, the facility’s
inattention contributed to two residents’ hospitalizations for Coumadin toxicity. CMS
Op. Br. at 7.

Resident 15 (R15). In February 2007, R15 was a sixty-nine year old man with a history
of atrial fibrillation, for which he was prescribed Coumadin. P. Ex. 3, at 13. His care
plan identified him as at risk for bleeding and “abnormal labs” secondary to anticoagulant
therapy, and called for “labs as ordered” and “INR between 2.0 — 3.0 or per physician’s
parameters.” CMS Ex. 47, at 9.

A document titled “lab tracking log” indicates that, prior to February 18, R15's INR target
values were set at 1.8 — 3.0. On January 19, 2007, his INR test results were below that
target, at 1.6. CMS Ex. 47, at 14.

+ PT/INR tests evaluate the ability of blood to clot properly. The INR is the ratio
of an individual’s prothrombin time to a control (i.e., normal) sample. The higher the
INR, the greater the chance of bleeding. A very low INR suggests the risk of a blood
clot. Normal ranges for a healthy person are 0.9 — 1.3; for people on Coumadin, desirable
ranges may be 2.0 to 3.0. However, many factors — such as patient age, gender, test
method — can affect the test results, so the physician generally determines an acceptable
range for each individual patient. See CMS Ex. 14, at 2 (Kralka Decl. § 9).
7

A physician telephone order, dated January 26, 2007, mentions the 1.6 INR, which the
physician, Dr. Robert Gunnell, apparently found acceptable since he ordered no change in
the Coumadin dosage. CMS Ex. 47, at 25. Dr. Gunnell ordered the INR rechecked in
two weeks, on February 9. CMS Ex. 47, at 26.

Thereafter, however, on February 4, 2007, Dr. Gunnell ordered a two-week course of the
antibiotic, Flagyl, to treat a clostridium infection, and R15 was given his first dose at
noon that day. CMS Ex. 47, at 12, 21, 26, 38; P. Ex. 3, at 9. The following day, the
pharmacy sent a written warning that the antibiotic medication could lead to significant
drug interaction with Coumadin; specifically, it could increase INR. The pharmacist
recommended “Monitor INR Day 3 and following antibiotic course.” P. Ex. 3, at 10.
Apparently, the times of highest risk for a drug interaction are when the drug is initiated
and when it is discontinued. P. Ex. 3, at 5.

CMS asserts that the facility did not communicate the pharmacist’s warning to R15's
physician. Apparently the pharmacy forwarded a copy to him because Dr. Gunnell
appears to have signed and dated the document. Although difficult to read, Dr. Gunnell’s
signature appears to be dated “2/7/07.” The form asks the physician to respond with
instructions, but the physician did not. CMS Ex. 20, at 2 (McKay Decl. ¥ 10).

CMS is correct that facility staff had no evidence that Dr. Gunnell knew about the
pharmacy warnings. He made no changes in R15's orders. His treatment notes do not
mention any concerns about a possible drug interaction. CMS Ex. 47, at9, 12,22. For
its part, the facility made no changes to R15's care plan to reflect the heightened risk.
CMS Ex. 47, at 9, 22.

R15 underwent the previously ordered PT/INR check on February 9, but, notwithstanding
the pharmacist’s warning, his next PT/INR check was not scheduled for another four
weeks. CMS Ex. 47, at 22,26. His INR on February 9 was 2.3. CMS Ex. 47, at 14.

On the evening of February 9, a facility nurse reports “scant amount” of rectal bleeding
with his bowel movement, but it was “controlled easily” and she attributed it to
hemorrhoids. CMS Ex. 47, at 22. The physician was apparently not notified.

By 7:00 a.m. on February 10, however, R15 had had two additional bouts of rectal
bleeding, described as bright red and dark red. The facility sent him to the emergency

* The record is not altogether clear on this, but it appears that R15 had earlier been
prescribed antibiotics for a foot infection. An undated physician note speculates that his
colitis “may be due to antibiotic therapy” and that “he will remain on antibiotics for the
time being” while waiting for the results of a C-difficile culture, which presumably was
the culture that detected his clostridium infection. CMS Ex. 47, at 11. This earlier
program of antibiotic therapy is not the subject of the deficiencies cited here.
8

room where his PT/INR was too high to measure (“extremely high, above 100”). P. Ex.
3, at 16; CMS Ex. 47, at 6, 22. Ina February 10, 2007 report, the hospital physician, Dr.
Wyssem Ramdani wrote:

It is a well known fact that Flagyl interacts with Coumadin
and would increase the Coumadin level, of course, make the
Coumadin toxicity very likely. This is probably . . . the cause
of his high INR at this time, which the patient has ongoing
lower gastrointestinal bleed.

CMS Ex. 47, at 6-7; P. Ex. 3, at 16-17. R15 was diagnosed with Coumadin toxicity, was
ospitalized for three days, and required blood transfusions. CMS Ex. 47, at 10, 22,

Contrary to Petitioner’s assertion, CMS does not fault Dr. Gunnell for ordering both
Flagyl and Coumadin. P. Op. Br. at 4-5; CMS Ex. 3, at 6-16; CMS Cl. Br. at 9. Rather,
CMS faults the facility because it did not intervene when, by all appearances, Dr. Gunnel
was not aware of or had ignored the pharmacy warnings and, without explanation, failed
to order the PT/INR monitoring during and immediately following R15's antibiotic
treatment. At a minimum, the facility should have consulted Dr. Gunnell to ensure that

e had received and understood the pharmacy warning and had made an informed
decision not to monitor R15's blood levels as recommended.

n an undated, unauthenticated statement, Dr. Gunnell claims that he was, in fact,
complying with the pharmacy recommendation. He writes:

On recommendation of the consulting pharmacy service (who
had identified the risk of drug interaction) P.T. and P.T. INR

levels were obtained four days after combination therapy had
been started.

P. Ex. 3, at 1. But Dr. Gunnell’s claim is not substantiated by the documentary evidence.
R15's PT/INR was measured on the sixth day, not the recommended third day of the
course of antibiotics, and this measurement was plainly unrelated to any recommendation
from the pharmacy. Dr. Gunnell had ordered the test back in January, well before R15
began taking Flagyl. Further, the pharmacy also recommended an additional test upon
completion of the course of antibiotics, which would have been on or about February 17.
On February 9, Dr. Gunnell ordered R15's next PT/INR “in 4 weeks.” CMS Ex. 47, at
26.

® R15 received his first dose of Flagyl on February 4, which was therefore “Day
1.” He was tested on February 9 — Day 6 of the two-week course of antibiotic treatment.
9

Petitioner makes much of the fact that R15's blood was within acceptable limits on
February 9, the day before R15 presented to the emergency room, and argues, based on
the physician statement (but with no reference to any underlying medical evidence), that
R15's bleed was not due to Coumadin toxicity, but to a lesion. P. Cl. Br. at 6 et seq.

These assertions miss the point. When it started administering Flagyl to R15, the facility
knew, or should have known, that he was at increased risk, and that his existing plan for
monitoring INR levels was likely inadequate. To attain or maintain “the highest
practicable physical . . . well-being” he would require more frequent testing. When the
physician neither commented nor acted, the facility, at a minimum, was obligated to
inquire.

Finally, the medical evidence establishing a connection between R15's INR and his
hospitalization seems pretty overwhelming. But even if R15 had not suffered Coumadin
toxicity or other bleeding problems related to his medication, the facility’s inattention to
his needs certainly put him at significant risk for such problems, and therefore violated
the quality of care regulation.

Resident 19 (R19). R19 was an 80-year-old woman taking Coumadin because of atrial
fibrillation. She also suffered from renal failure and was on dialysis. CMS Ex. 37, at 1-2,
16; CMS Ex. 14, at 2 (Kralka Decl. § 8). Her care plan identified as a problem the risk
for bleeding and “abnormal labs” secondary to anticoagulant use. It listed an INR range
of 2.0 — 3.0, and, among other interventions, called for monitoring and reporting
abnormal bleeding and increased platelet count, and “labs as ordered per Davita.” CMS
Ex. 37, at 5.’

In fact, the facility seems to have assumed virtually no responsibility for monitoring R19's
blood levels. Instead, it relied completely on the dialysis center to perform the
monitoring. Although the facility has not provided any evidence that it had any written
procedures, the system was apparently supposed to work as follows: R19's blood would
be drawn at the dialysis center on Mondays and Wednesdays and the samples sent to an
out-of-state laboratory for testing. Two days after the blood draw, the lab sent the test
results back to the dialysis center. The dialysis center then called the test results into the
facility, which recorded them on to the resident’s lab tracking log. It did not send copies
of the lab reports, however. CMS Ex. 14, at 2 (Kralka Decl. § 12);* CMS Ex. 37, at 6.

7 “Tavita” apparently refers to R19's dialysis center, although it is also the name
of the laboratory that tested her blood. See CMS Ex. 38; P. Cl. Br. at 8.

* The facility obtained copies of the lab reports, CMS Ex. 38, during the survey.
CMS Ex. 14, at 2 (Kralka Decl. § 12).
10

Larry Miller, RPh, CMS’s pharmacist/surveyor, testified that same-day reporting of
PT/INR test results is the standard, acceptable practice, and that a two-day delay is not
acceptable. CMS Ex. 22, at 2 (Miller Decl. 7); accord, CMS Ex. 14, at 2 (Kralka Decl.
q 12).

On April 18, 2007, R19's physician prescribed for her a week-long course of the
antibiotic Keflex to treat a carbuncle on her neck. CMS Ex. 37, at 8,9, 11. Like Flagyl,
Keflex is a medication known to increase Coumadin’s anti-coagulant effect. CMS Ex.
77, at 2, 6; CMS Ex. 68, at 3. No evidence suggests that anyone at the facility even noted
that the antibiotic put her at increased risk.

At 6:00 p.m. on April 24, the nurse reported that R19 had been having large, loose stools
with “[large amount] of blood present [with] mucous.” CMS Ex. 37, at 14. At 10:30 the
following morning, a nurse called R19's physician’s office reporting the blood, and
requesting an order for hemoccult and C-difficile testing. At 12:30 p.m. she called again
to report a large bright red stool with dime-sized clots, and received an order to perform
an INR test immediately. Blood was drawn and sent to the lab, which, at 2:30 p.m.
reported an INR of 6.46. CMS Ex. 37, at 14, 20.” She was taken to the emergency room,
and diagnosed with a gastrointestinal bleed and coagulopathy secondary to Coumadin.
She was hospitalized, administered Vitamin K and two units of blood plasma. CMS Ex.
37, at 16-19.

Petitioner nevertheless argues no deficient practice. “These matters were within the
control of the resident’s physician and the dialysis center, not [the facility].” P. Op. Br. at
5. Without any doubt, the resident’s physician and dialysis center are responsible for
monitoring their patients, but that does not eliminate the facility’s independent
responsibility under the regulation to monitor R19's blood levels so that she could
maintain “the highest practicable physical . . . well-being.”

The facility is, of course, free to contract with an outside entity to perform this function,
so long as it makes certain that those services are adequate. 42 C.F.R. § 483.75(h)(2).
Here, the facility’s awkward and problematic “system” did not ensure accurate and timely
monitoring of R19's blood levels. As the following chart shows, comparing the actual test
reports to the facility’s lab tracking log belies any claim that the facility received and
maintained a complete and accurate accounting of R19's INR test results. Some data is
missing; in some cases the lab reports do not coincide with the tracking log. Indeed, for
more than three weeks prior to her gastrointestinal bleed, the facility had not been
tracking her INR values at all, apparently because the nurse responsible for
documentation was on vacation. CMS Ex. 3, at 21.

° Petitioner alludes to its small-town location to justify the delays in obtaining INR
test results. P. Cl. Br. at 8. In fact, the test is relatively simple and inexpensive, and the
facility was obviously capable of performing it and obtaining timely results.
11

Date Blood Drawn INR per lab report INR per Lab Tracking Log"”
2/14/07 2.4 (CMS Ex. 38, at 1) not recorde

2/21/07 1.7 (CMS Ex. 38, at 4) 1.7

3/07/07 2.3 (CMS Ex. 38, at 6) not recorde

3/14/07 1.5 (CMS Ex. 38, at 7) 1.5 (dated 3/16/07)"
3/21/07 2.8 (CMS Ex. 38, at 9) not recorde

3/28/07 >10 (CMS Ex. 38, at 11)'? 2.98 (dated 3/30/07)
4/04/07 4.2 (CMS Ex. 38, at 12) 4.72 (dated 4/2/07)
4/11/07 2.3 (CMS Ex. 38, at 36) not recorde:

4/18/07 3.2 (CMS Ex. 38, at 13) not recorde:

4/25/07 7.7 (CMS Ex. 38, at 15) 6.46"

5/09/07 1.9 (CMS Ex. 38, at 17) not recorde:

5/16/07 1.8 (CMS Ex. 38, at 18) not recorde:

5/23/07 1.7 (CMS Ex. 38, at 20) not recorde:

5/30/07 1.5 (CMS Ex. 38, at 22) not recorde:

6/06/07 1.6 (CMS Ex. 38, at 24) 1.6 (dated 6/8/07)
6/13/07 2.4 (CMS Ex. 38, at 25) not recorde:

6/27/07 3.4 (CMS Ex. 38, at 28) 3.4 (dated 6/29/07)
7/02/07 3.9 (CMS Ex. 38, at29) 3.9 (dated 7/4/07)
7/11/07 1.7 (CMS Ex. 38, at30) 1.7 (dated 7/13/07)

' CMS Ex. 37, at 6.

'' Blood was drawn on Monday and Wednesday and the results received on
Wednesday and Friday. It seems that the facility usually recorded the date it received the
test results, not the date the blood was drawn. But compare CMS Ex. 38, at 4 with CMS
Ex. 37, at 6 (2/21/07 log entry reflects date of blood draw). So the tracking log does not
even reliably reflect the dates on which the resident’s blood registered the listed INR
levels.

No explanation has been offered for the discrepancy between this lab report and
the tracking log entry. The lab report notes that the accuracy of its results had been
confirmed, and directed the clinician to correlate the results with the patient’s clinical
condition. However, the record suggests that the facility was not even aware of this
extreme result, since it was not recorded in the tracking log, and no nurses notes or other
indication of the facility’s response is in the record.

'S This reflects the test taken at the facility following R19's symptoms of a
gastrointestinal bleed. The record contains no evidence that the facility received from the
dialysis center a report of R19's April 25 test result of 7.7. Based on the facility’s
procedures, it likely would not have learned about this dangerously high INR until April
27.
12

Resident 18 (R18). R18 was a 54-year-old woman, admitted to the facility on June 14,
2007, who suffered from end stage renal disease and deep vein thrombosis for which she
was prescribed Coumadin. CMS Ex. 44, at 1. Her transfer order from Mercy General
Hospital calls for checking her PT/INR “stat [immediately] 6/25 then [every] week.”
CMS Ex. 44, at 6.

R18's care plan identified her as at risk for bleeding and abnormal labs secondary to
Coumadin use. Among the interventions listed are “labs as ordered” but no INR range is
listed. CMS Ex. 44, at 26. Her medication orders, dated June 14, 2007, say “Davita to
check PT/INR weekly.” CMS Ex. 44, at 7. A physician order dated July 3, 2007 calls
for daily Coumadin, and says, “Davita to do labs [and] dosing.” P. Ex. 2, at 5. I assume
y “dosing” he meant that Davita would determine the dosages to be administered;
facility staff actually administered the daily Coumadin to R18.

As discussed above, the facility had no reliable system in place for monitoring R18's test
results. It assumed that dialysis center staff would take care of it, and made virtually no
efforts to monitor the dialysis center’s performance in that regard. Test reports were not
forwarded to the facility; as with R19, the facility only obtained them from the dialysis
center at the time of the survey. CMS Ex. 16, at 2 (Lindsay Decl. § 10). And it appears
that, contrary to the orders in place, R18's PT/INR was measured only twice — on July 2,
and July 13. CMS Ex. 44, at 11, 12.

Petitioner maintains that the dialysis center “obtained all necessary tests and the resident
had normal PT/INR results.” P. Op. Br. at 5. In fact, the evidence presented
demonstrates that the dialysis center did not obtain all the necessary tests. According to
the orders, R18 was supposed to have been tested on June 25, and weekly thereafter.
Missing are tests from June 25, July 9, and/or July 20. A separate physician order, dated
July 19, calls fora PT/INR. P. Ex. 2, at 6. But there is no evidence of a blood draw in
response to this order until July 27. P. Ex. 2, at 1.

I reject Petitioner’s suggestion that the July 3 physician order (P. Ex. 2, at 5) eliminated
the order for weekly testing. The July 3 order changed the Coumadin dosage from 3 mg
per day (CMS Ex. 44, at 8) to “alternating 3 mg [and] 6 mg” dosages. The order for
weekly testing remained unchanged, as shown by the physician’s order sheet for the
period from July 1 through 31, 2007, which the surveyors photocopied at the time of the
survey. Had the physician’s order changed the frequency of testing, the order sheet
would have reflected the change. CMS Ex. 44, at 7. See, e.g., P. Ex. 1, at 5, 6; P. Ex. 3,
at 147-150 (reflecting handwritten changes on the printed order sheets).

I note also that accepting Petitioner’s interpretation of the July 3 order results in the
unacceptable alternative that the facility had absolutely no idea as to the ordered
frequency of the PT/INR testing for this resident.
13

Further, contrary to Petitioner’s claim, R18 never had a normal test result recorded. Her
INR range was supposedly 2.0 — 3.0, and her test results were consistently below that
range (1.32, 1.76, 1.85), except on July 27, when it was a dangerously high 5.81. P. Ex.
2,at 1.

2. The facility did not take reasonable steps to ensure
that its residents received supervision and assistance
devices to mitigate foreseeable risks of harm from
accidents.

The quality of care regulation also specifically requires the facility to “take reasonable
steps to ensure that a resident receives supervision and assistance devices designed to
meet his or her assessed needs and to mitigate foreseeable risks of harm from accidents.”
42 C.F.R. § 483.25(h)(2); Windsor Health Care Center, DAB No. 1902, at 5 (2003);
Asbury Center at Johnson City, DAB No. 1815, at 12 (2002); Koester Pavilion, DAB No.
1750, at 25- 6 (2000); Woodstock, DAB No. 1726, at 25. The regulation directs the
facility to anticipate what accidents might befall a resident and to take steps — increased
supervision or the use of assistance devices — to prevent them. Guardian Health Care
Center, DAB No. 1943, at 18 (2004).

A facility is permitted the flexibility to choose the methods it
uses to prevent accidents, but the chosen methods must
constitute an “adequate” level of supervision under all the
circumstances.

Windsor at 5.

July Survey. During the July survey, the surveyors cited multiple instances of inadequate
supervision and failures to follow care plans that resulted in accidents.

R5 was an 82-year-old man, admitted to the facility in 2001, whose diagnoses included
acute renal failure, coronary artery disease, congestive heart failure, depression, and
dementia. CMS Ex. 48, at 1. According to a February 8, 2007 risk identification form,
he was at risk for falls. CMS Ex. 48, at 22; CMS Ex. 18, at 2 (Maze Decl. 4] 7, 8).
Among other interventions, his care plan called for a two-person assist with toileting and
transfers; his bed was to be kept in the lowest position, with a mat on the floor next to it;
and he was to have pressure alarms on his bed and wheelchair. CMS Ex. 48, at 22; CMS
Ex. 18, at 2 (Maze Decl. § 8).
14

Undisputed evidence establishes that facility staff did not consistently follow the care
plan, and, between March | and June 1, 2007, R5 fell six times."

. On March 1, 2007, at 11:45 p.m., RS was found “sitting on floor on blue mat” of
his room, apparently uninjured. According to a nurses note, he had tried to get out
of bed when his “body pillow slipped out [and resident] had an easy way to
remove self.” CMS Ex. 48, at 5. The facility’s incident reports provide few
additional details, except to say that neither environment nor equipment were
factors. In future, according to the reports, bolsters would be applied to his bed to
prevent him from sliding out. CMS Ex. 48, at 24. Neither the nurses notes nor the
incident reports mention whether a bed alarm had been in place nor whether it had
sounded.

. On March 9, 2007, at 9:30 p.m., he was again found on the floor, uninjured, after
getting out of bed to get himself some water. CMS Ex. 48, at 9, 26-29. Nurses
notes indicate that his bed was in the lowest position as called for in the care plan,
but, again, neither the notes nor the incident reports mention anything about a bed
alarm.

. On March 14, 2007, at midnight, he was again found, uninjured, on the floor after
getting out of bed for a drink of water. His alarm was sounding. CMS Ex. 48, at
11, 18, 30, 31-33. A hand-written note says, “I don’t know what more to do for
this man to keep him safe, other than move him to room 301.” CMS Ex. 48, at 31.

. On March 17, at 1:30 p.m., he apparently pulled himself out of bed, and was found
sitting by the side of his bed, the alarm sounding. However, his bed was not in its
lowest position, as required by his care plan, and the required bolsters were not in
place. CMS Ex. 48, at 12, 18, 35-39. The investigation worksheet cites as error
the staff’s failures to put the bed in its lowest position and to put bolsters in place.
CMS Ex. 48, at 37. In her written statement, the nurse aide says that she had just
laid R5 down with “all alarms on him” and was still in the room. CMS Ex. 48, at
39. She does not mention whether the alarms sounded, and there seems to have
been no follow-up investigation to determine whether they had been properly
applied. If, in fact, the nurse aide was in the room when the alarm sounded, her
inability to intervene to prevent the fall is baffling and required investigation.

. On March 24, at 1:10 a.m., R5 was again found on the floor next to his bed,
uninjured except for a reddened wrist caused by his call light’s having been
wrapped around it. CMS Ex. 48, at 15, 19, 40-43. A note explains that the

' On February 26, 2007, R5 was found face down on the floor in front of his
wheel chair with his personal alarm sounding. He sustained a hematoma to the forehead.
CMS Ex. 48, at 17. CMS does not cite this incident.

15

pressure alarm had slipped, so it apparently had not sounded. CMS Ex. 48, at 18.
The investigative report indicates that RS would be moved to room 301, and
“remove strips and secure pressure alarm to bed under resident’s shoulders.” CMS
Ex. 48, at 19, 43.

. On May 31, at 4:30 p.m., R5 was found on the floor between his bed and the wall.
The bed had apparently not been locked in place because the locks were broken,
and, when it moved, he rolled out. CMS Ex. 48, at 44-47. According to one
report, his bed was in the low position with a pressure alarm in place, but the
reports do not say whether the alarm sounded. CMS Ex. 48, at 21, 45.

These incidents establish that the facility was not providing R5 the supervision and
assistance devices necessary to prevent accidents. Interventions set forth in the care plan
were not consistently followed. That staff repeatedly were unable to reach the resident in
time to prevent a fall after the alarm sounded shows inadequate supervision. As early as
March 14, staff recognized that no one responding to an alarm could reach him in time,
yet, he was not moved to a more accessible location until 10 days — and two falls — later.

am also troubled by the facility’s consistently inadequate investigative reports. The
reports say that RS “was found” on the floor, but provide no indication of how long he
ad been there nor what happened after he fell. They often fail to indicate whether an
alarm was in place and functioning at the time of the fall. See CMS Ex. 18, at 2 (Maze
Decl. {] 9, 10); Century Care of Crystal Coast, DAB No. 2076, at 21 (2007), aff'd
Century Care of Crystal Coast v. Leavitt, No. 07-1491 (4" Cir. 2008) (By not
investigating, the facility loses an opportunity to analyze and correct its problems).

Resident 17 (R17). R17 was admitted to the facility on July 13, 2007, with a diagnosis of
metastatic prostate cancer, and, at that time, the facility identified him as at risk for falls.
CMS Ex. 49, at 5, 9. Among other interventions, his care plan called for a pressure alarm
for his bed. CMS Ex. 49, at 5, 6. At 11:45 on the night of his admission, he was found
on the floor of his room, with a laceration and swelling to his left ear. CMS Ex. 49, at 10-
5. The alarm had not sounded because it was not attached to his bed (“people just didn’t
do it”); it was sitting on the dresser. CMS Ex. 49, at 3, 11; CMS Ex. 18, at 2 (Maze Decl.
q 12).

Resident 8 (R8). R8 was an 86-year-old woman, admitted to the facility in August 2006.
She suffered from renal failure, osteoporosis, glaucoma, depression, and Alzheimers
disease. CMS Ex. 35, at 1. She was at risk for falls, and, among other interventions, her
care plan required pressure alarms for her wheel chair and for her bed. CMS Ex. 35, at 5,
6. According to CMS, her medical record documented six falls between May 4 and July
7, 2007, but the facility investigated only four of these falls. CMS Ex. 35, at 4.

16

. At 8:25 p.m. on May 4, 2007, R8 fell out of bed, and suffered a knot on the back of
her head. Two nurse aides heard the alarm go off, but said that they were unable
to assist her because they were caring for another resident who required a 2-person
assist. A third nurse aide was on her break. CMS Ex. 35, at 15-19. That no one
was available to assist a resident who was in jeopardy shows inadequate
supervision.

. At 10:30 p.m. on May 18, 2007, R8 rolled out of bed and sustained a skin tear on
her left elbow. CMS Ex. 35, at 20. The investigative report offers no additional
information, so the record is silent as to whether anyone witnessed the accident or
an alarm sounded. CMS Ex. 35, at 21-23.

. At 7:30 p.m. on July 12, R8 was found on the floor of the dining room, uninjured.
CMS Ex. 35, at 24. Surveyor notes indicate that the dining room is about 25 feet
from her own room. CMS Ex. 35, at 4. The investigative report is silent as to the
circumstances surrounding her fall. According to surveyor notes, her alarm did not
sound, although I see no reference to any alarm in the facility documents. CMS
Ex. 35, at 4, 25.

. On July 17, 2007, at 8:00 p.m., R8 fell from her Broda chair,'* sustaining a bruised
left elbow. CMS Ex. 35, at 26-31. Staff had failed to unlock the chair’s brakes
after she completed an activity, which apparently caused her to fall when she
attempted to propel herself. CMS Ex. 35, at 27.

Surveyor notes refer to two additional incidents, for which the facility had no incident
reports. On May 7, 2007, at 8:25 p.m., R8 fell out of bed and hit the back of her head.
The alarm sounded. On June 12, 1007, at “9:30,” the alarm sounded and R8 was found
beside her bed. CMS Ex. 35, at 4. Although the record contains no facility
documentation as to the purported incident of May 7, the facility’s “risk identification
review” confirms that on June 12, the resident sustained a fall (although it places the time
at 7:15 p.m.). Petitioner does not explain what, if anything, happened at that time, except
to say generally that “incident reports were done for each fall.” P. Op. Br. at 7. Inasmuch
as Petitioner has not produced an incident report for the June fall, I can reasonably infer
that, contrary to state law, acceptable standards of practice, and its own policies, the
facility did not prepare and/or maintain an incident/accident report of the fall. CMS Ex.
69. Failure to investigate an accident can itself be evidence of inadequate supervision.
Lake Park Nursing and Rehabilitation Center, DAB No. 2035, at 11 (2006); see also
Century Care of Crystal Coast, DAB No. 2076, at 21 (2007), aff'd Century Care of
Crystal Coast v. Leavitt, No. 07-1491 (4" Cir. 2008).

'S A Broda chair is an adjustable chair that sits on casters, which makes it easier to
propel.
17

Resident 9 (R9). R9 was admitted to the facility in March 2007, and was 85 years old at
the time of the survey. She suffered from arteriosclerotic heart disease, dementia, and
memory loss. She had a history of elopement. CMS Ex. 36, at 1,3. She was at risk for
falls, and her care plan called for a pressure alarm in her wheel chair and on her bed.
CMS Ex. 36, at 5, 7. She also wore a wanderguard ankle bracelet. CMS Ex. 36, at 7.

. On May 15, 2007, at 7:10 a.m., an agency nurse found R9 on the floor at the
bathroom door of her room, having apparently hit her head. No alarm had
sounded. CMS Ex. 36, at 9, 15. The alarm had not been “hooked.” CMS Ex. 36,
at 16.

. On May 17, at 1:45 p.m., a nurses note indicates that the nurse heard the alarm
sounding, and found the resident sitting on the floor near her bed. She was not
injured. CMS Ex. 36, at 10.

. On June 9, R9 attempted unsuccessfully to elope. Then, on June 11, 2007, she
successfully exited the facility. Fortunately, a nurse on break happened to be
sitting outside when R9 “came flying out the door, heading down [the] path.”
CMS Ex. 36, at 11. But the nurses note does not mention whether an alarm went
off and I see no evidence of an investigative report. Indeed, the facility provides
no evidence that it investigated the incident at all, nor that it took steps to ensure
that R9 not elope. Petitioner argues that R9 did not elope because she was so
quickly returned to the facility. P. Op. Br. at 7. That an employee happened to be
in the area when she exited the facility was fortuitous, but her ability to exit,
apparently undetected by the staff who were supposed to be responsible, further
suggests that she was not properly supervised.

. At 5:30 a.m. on June 14, the bed alarm sounded, and staff found R9 sitting on the
floor, “trying to scoot self over to [the bathroom].” CMS Ex. 36, at 12.

. On June 24, at 4:00 a.m., the alarm sounded and staff found R9 sitting on the floor
next to her bed. CMS Ex. 36, at 13.

Thus, the evidence again shows multiple instances in which staff were unable to reach a
resident they knew to be in potential jeopardy; staff failed to follow a vulnerable
resident’s care plan; and staff inadequately investigated incidents.

September survey. When the surveyors returned to the facility in September 2007, they
concluded that staff were still not providing adequate supervision and assistance devices
to prevent accidents, citing incidents involving R39.

R39 was a 54-year-old man who was admitted to the facility on August 1, 2007, suffering
from Charcot-Marie-Tooth disease. CMS Ex. 57, at 1, 9. Charcot-Marie-Tooth disease is
18

a neurological disorder that affects the peripheral nerves. Weakness in the foot and lower
leg muscles causes “foot drop” and a high-stepped gait, which can result in frequent
tripping and falls. CMS Ex. 58. R39 wore leg braces, and was assessed as a fall risk.
CMS Ex. 57, at 15, 17, 18. His care plan required a two-person assist for transfers. CMS
Ex. 57, at 17, 18.

. According to a nurses note, on August 11, 2007, R39 was “being assisted” in the
bathroom when his brace “gave way,” causing his knee to buckle and scrape
against the wall. He suffered a scratch. CMS Ex. 57, at 11. The facility offers no
evidence that it investigated this incident. The note does not mention whether he
was assisted by two staff members, as required by his care plan.

. According to an August 29 nurses note, the nurse was called to the resident’s room
by a nurse aide, and found R39 sitting on the bathroom floor. He had fallen and
suffered abrasions to his left knee and right toe. CMS Ex. 57, at 12. An incident
report indicates that he was transferring to the toilet; he was barefoot, when he
should have been wearing non-skid footwear; he was assisted by only one CNA,
instead of the two called for by his care plan; and the CNA did not use a gait belt,
as required by the standard of care and the facility policies. CMS Ex. 57, at 19-24;
CMS Ex. 79 (“It is standard care to use a gait belt on all residents while
transferring .... It is also standard of care to make sure every resident has non-
skid footwear of some sort during transfers.”)

Thus, the evidence establishes that, at the time of the September survey, staff still were
not providing adequate supervision and assistance devices to prevent accidents. They
were not consistently following the resident care plans; they were not adequately
investigating and reporting incidents. Substantial evidence thus establishes that the
facility’s noncompliance with the quality of care regulation, 42 C.F.R. § 483.25(h),
continued.

I recognize that CMS has cited numerous other deficiencies, including failure to ensure
that residents receive nutrition adequate to his/her needs (42 C.F.R. § 483.25(i)(1));
failure to ensure that residents’ drug regimes are free from unnecessary drugs (42 C.F.R.
§ 483.25(1)(1)); failure to provide adequate pharmaceutical services (42 C.F.R.

§ 483.60); failure to maintain a sanitary, orderly, and comfortable environment (42 C.F.R.
§ 483.15(h)(2)); and failure to prevent/promote healing of pressure sores (42 C.F.R.

§ 483.25(c)). In the interests of administrative economy, I decline to address these
additional deficiencies since, as discussed below, I conclude that the quality-of-care
deficiencies that I have addressed more than justify the relatively low penalties imposed.
See Grace Healthcare of Benton, DAB No. 2189, at 5 (2008).
19

B. Petitioner’s inadequate system for monitoring the PT/INR levels of
its high risk residents posed immediate jeopardy to their health and
safety.

I next consider whether CMS’s immediate jeopardy finding was “clearly erroneous.” 42
C.F.R. § 498.60(c)(2). Immediate jeopardy exists if the facility’s noncompliance has
caused or is likely to cause “serious injury, harm, impairment or death to a resident.” 42
C.F.R. § 488.301. CMS’s determination as to the level ofa facility’s noncompliance —
which includes its immediate jeopardy finding — must be upheld unless it is “clearly
erroneous.” 42 C.F.R. § 498.60(c). The Departmental Appeals 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);
Florence Park Care Center, DAB No. 1931, at 27-28 (2004) citing Koester Pavilion,
DAB No. 1750 (2000).

Here, strong evidence links R15's and R19's gastrointestinal bleeds to the facility’s
inadequate monitoring of their PT/INR levels. But I need not make that connection in
order to sustain CMS’s immediate jeopardy finding. So long as the facility’s
noncompliance “is likely to cause serious injury, harm [or] impairment,” its deficiencies
pose immediate jeopardy. Here, facility residents were at high risk for complications
related to their medications. Their health and safety required careful PT/INR monitoring.
Yet the facility had no reliable systems in place to ensure that monitoring. Indeed, the
facility did not even recognize that it had any responsibilities in this regard. Where the
facility assumed virtually no responsibility for assuring the accurate and timely
monitoring of its vulnerable residents’ blood levels, CMS’s determination that such
practices pose immediate jeopardy to resident safety was not clearly erroneous.

C. The penalties imposed are reasonable.”

Because the facility was not in substantial compliance with program requirements, CMS
has the authority to impose a remedy, and I have no authority to review CMS’s choice of
remedies, in this case, per day CMPs. 42 C.F.R. § 488.438(e)(2); 42 C.F.R.

§ 498.3(b)(13); see also 42 C.F.R. § 488.408(g)(2).

For the one day of immediate jeopardy, CMS has imposed a penalty of $5500, which is in
the low to mid range for situations that pose immediate jeopardy ($3050 to $10,000). 42

‘6 Although at the conclusion of its closing brief Petitioner insisted that it has
preserved as an issue the reasonableness of the penalties imposed, it has presented no
actual arguments on the matter, except to say that the deficiency findings were
unfounded. P. Cl. Br. at 15, n.3. I nevertheless address the issue here.
20

C.F.R. § 488.438(a)(1). For the 55 days of substantial noncompliance immediately
following the July survey, its penalty, $250 per day, is in the low end of the penalty range
for situations of substantial noncompliance that does not pose immediate jeopardy ($50-
$3000). When, at the time of the September survey, the facility had not brought itself
into substantial compliance, CMS increased the penalty to $400 per day, but that amount
is still at the low end of the range.

To determine the reasonableness of the penalty, I apply the factors listed in 42 C.F.R.

§ 488.438(f): 1) the facility’s history of noncompliance; 2) the facility’s financial
condition; 3) factors specified in 42 C.F.R. § 488.404; and 4) the facility’s degree of
culpability, which includes neglect, indifference, or disregard for resident care, comfort,
or safety. The absence of culpability is not a mitigating factor. 42 C.F.R. § 488.438(f).
The factors in section 488.404 include: 1) the scope and severity of the deficiency; 2) the
relationship of the deficiency to other deficiencies resulting in noncompliance; and 3) the
facility’s prior history of noncompliance in general and specifically with reference to the
cited deficiencies.

It is well-settled that, in reaching a decision on the reasonableness of the CMP, I may not
consider CMS’s internal decision-making processes. Instead, I consider whether the
record evidence concerning the relevant regulatory factors supports the finding that the
amount of the CMP is at a level “reasonably related to an effort to produce corrective
action by a provider with the kind of deficiencies found and in light of the other factors
involved” (facility history, financial condition, culpability). Barn Hill Care Center, DAB
No. 1848, at 21 (2002); Community Nursing Home, DAB No. 1807, at 22 et seg. (2002);
Emerald Oaks, DAB No. 1800, at 9 (2001); CarePlex of Silver Spring, DAB No. 1683, at
8 (1999).

The facility’s dreadful compliance history suggests that it is the kind of facility for which
substantial penalties are necessary in order to induce compliance. As noted above, the
facility was not in substantial compliance with LSC requirements at the time of its July
2007 LSC survey. The June 2007 complaint investigation showed that it was not in
substantial compliance with regulations governing abuse (42 C.F.R. § 483.13(b)), staff
treatment of residents (42 C.F.R. § 483.13(c)), comprehensive care plans (42 C.F.R.

§ 483.20(k)), and, as here, quality of care (42 C.F.R. § 483.25). Except for the care
planning, all of its deficiencies were cited at scope and severity level E (pattern of
noncompliance with the potential for more than minimal harm). CMS Ex.

And, as CMS points out, the facility has not been in substantial compliance during any
annual survey since before 2003. Its deficiencies have included quality of care violations
(October 2005 and September 2006 surveys), failure to prevent accidents (October 2005
and September 2006 surveys), and failure to prevent/heal pressure sores (October 2006).
Additional complaint investigations conducted in April 2005 and November 2005 found
the complaints substantiated. CMS Ex. 80.

21

Without even considering the other factors, this history justifies raising the penalty well
above the minimal amounts.

But none of the other factors augers in favor of lowering the CMPs. Petitioner has not
alleged that its financial condition affects its ability to pay the penalty. The facility is
culpable for its almost complete abdication of any responsibility for monitoring the INR
levels of its vulnerable residents. The number and circumstances of incidents suggest that
the facility’s failure to ensure adequate supervision to prevent accidents was related to
systematic failures in planning, investigating, staffing, and training, that seriously
undermined its ability to protect its residents from harm. The facility is culpable for these
failures.

Finally, increasing the penalty following the September survey findings is reasonable.
The facility had been afforded ample opportunity to correct its deficiencies and had not
done so, which shows that the lower CMP amount was insufficient to produce corrective
action.

IV. Conclusion

Thus, because the facility did not monitor the safety and effectiveness of its vulnerable
residents’ anti-coagulant medications and because it did not adequately supervise its
residents, placing them at significant risk of suffering an accident and potentially serious
injury, it was not in substantial compliance with 42 C.F.R. §§ 483.25 and 483.25(h)(2)
from July 20 through November 15, 2007. On July 20, 2007, its deficiencies posed
immediate jeopardy to resident health and safety. I find reasonable the $5500 per day
CMP for one day of immediate jeopardy. I also find reasonable the $250 per day penalty
for the period July 21 through September 13, 2007, and the $400 per day penalty for the
period September 14 through November 15, 2007.

/s/
Carolyn Cozad Hughes
Administrative Law Judge


Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

Decision No. CR1832
Centers for Medicare & Medicaid
Services.

In the Case of: )
)

Kingsville Nursing and Rehabilitation _) Date: August 14, 2008
Center (CCN: 67-5815), )
)
Petitioner, )
)

-V.- ) Docket No. C-08-177

)
)
)
)

DECISION GRANTING SUMMARY DISPOSITION

I grant summary disposition in favor of the Centers for Medicare & Medicaid Services
(CMS) and against Petitioner, Kingsville Nursing and Rehabilitation Center, and I sustain
the imposition of two per-instance civil money penalties of $4,000 and $6,000.

I. Background

Petitioner is a skilled nursing facility doing business in Kingsville, Texas. It participates
in Medicare. Its participation in that program is governed by sections 1819 and 1866 of
the Social Security Act and by regulations at 42 C.F.R. Parts 483 and 488. Its hearing
rights in this case are governed by regulations at 42 C.F.R. Part 498.

A Medicare compliance survey was conducted at Petitioner’s premises in September 2007
(September survey). The surveyors concluded that Petitioner was not complying
substantially with participation requirements. CMS accepted the surveyors’ findings and
determined to impose the remedies that I describe in the opening paragraph of this
decision.
2

Petitioner filed a hearing request challenging CMS’s determination and the case was
assigned to me for a hearing and a decision. The parties filed pre-hearing exchanges of
proposed exhibits and pre-hearing briefs. Then, CMS moved for summary disposition
and Petitioner opposed the motion.

CMS filed a total of 36 proposed exhibits which it designated as CMS Ex. 1 - CMS Ex.
36. Petitioner filed a total of 98 proposed exhibits which it designated as P. Ex. 1 - P. Ex.
98. Lam receiving all of these proposed exhibits into the record of the case and I cite to
some of them in this decision for purposes of illustration. However, my decision is based
entirely on the undisputed material facts as alleged by the parties.

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

1. The undisputed material facts establish that 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.

1. The undisputed material facts establish that Petitioner failed to comply
substantially with Medicare participation requirements.

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

The regulation that is 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).
3

The regulation imposes several distinct duties on nursing facilities. First, a nursing
facility must assess each of its residents in order to determine which of them have
pressure sores or are at risk for developing them and also to identify precisely what are
the risk factors faced by each resident. Secondly, a facility must p/an the care of each
resident who has a pressure sore or who is at risk for developing one to ensure that it
takes all reasonable measures to prevent the development of sores and to promote the
speedy healing of those that exist. Finally, a facility must implement completely and
diligently all of the measures that it has identified as being necessary for each resident
who is identified as being at risk for or as having pressure sores.

The case for summary disposition against Petitioner rests on allegations that Petitioner
failed to discharge these obligations. First, CMS asserts that Petitioner failed to carry out
plan of care directives ordering that residents who were identified as being vulnerable to
developing pressure sores be repositioned on a regular basis in order to relieve pressure.
CMS identifies the following residents whose care plans required that they be
repositioned at two-hour intervals and who, according to CMS, were not repositioned:
Residents #s 24, 25, 26 and 11.

CMS contends that it is undisputed that each of these residents, all of whom were
essentially helpless, had been identified by Petitioner’s staff as being at risk for pressure
sores. CMS Ex. 12, at 13; CMS Ex. 13, at 11; CMS Ex. 14, at 14; CMS Ex. 8, at 18.
Each of these residents had a care plan that specifically required that the resident be
repositioned once every two hours as a pressure sore prevention intervention. Jd. CMS
asserts that a surveyor (and, in the case of Resident # 11, two surveyors) observed each of
these residents on multiple occasions over an approximately eight-hour period on
September 13, 2007. Two of these residents, Residents #s 24 and 25, were observed to be
lying only on their backs throughout the period. CMS Ex. 5, at 22. Residents #s 26 and
11 were observed to be lying only on their backs during the first six hours of the same
eight hour period. CMS’s motion for summary disposition at 2 - 10. CMS Ex. 5, at 21;
CMS Ex. 6, at 52.

According to CMS, these facts comprise irrefutable proof that Petitioner failed to comply
with the regulatory requirement that it implement every reasonable intervention to protect
the four residents from developing pressure sores. The undisputed facts, according to
CMS, establish that Petitioner failed to comply with the very care plans that it had
developed to protect these residents.

Second, CMS contends that two of Petitioner’s residents, identified in the September
survey report as Residents #s 33 and 39, developed pressure sores that Petitioner did not
show were clinically unavoidable. According to CMS, the undisputed material facts
show that both of these residents had entered Petitioner’s facility without pressure sores.
4

However, on September 20, 2007, Petitioner’s staff documented an area of redness on
Resident # 33’s buttock. CMS Ex. 16, at 15. On the following day, September 21, 2007
Petitioner’s staff identified pressure sores on Resident # 33’s right hip and buttock. /d., at
16. On that same date, the staff identified a pressure sore on Resident # 39’s right leg.
CMS Ex. 18, at 47. On the following day, September 22, 2007, the staff identified an
additional pressure sore on the resident’s right leg and two blisters on the resident’s left
ip. Id., at 48.

CMS emphasizes that these residents’ development of multiple pressure sores is made
remarkable by the fact that neither of them had been identified by Petitioner’s staff as
eing at a high risk for development of pressure sores. Indeed, on August 17, 2007 and
September 21, 2007 — the day after the staff first documented redness on Resident # 33’s
uttock and the day before the staff first identified pressure sores on that resident — the
staff assessed that resident as being at low risk for developing a pressure sore. CMS Ex.
6, at 14. On multiple occasions during her stay at Petitioner’s facility, Resident # 39 had
een assessed by the staff as being at low risk for developing pressure sores. CMS Ex.
8, at 44-45. On September 21, the date Petitioner’s staff first found pressure sores on
Resident # 39, Petitioner’s staff assessed the resident as being only at moderate risk for
developing sores. /d., at 26.

CMS argues that there is nothing in these residents’ records to show that they would have
inevitably developed pressure sores despite Petitioner’s best efforts to prevent them. In
light of that, CMS contends that the residents’ development of sores is undeniable proof
that Petitioner failed to comply with its regulatory obligations.

I find CMS’s arguments to be persuasive if not rebutted by Petitioner. In the absence of
any dispute of the facts cited by CMS these facts make out a powerful case of
noncompliance by Petitioner with the requirements of 42 C.F.R. § 483.25(c).

The facts alleged by CMS concerning the staff’s observed failure to reposition Residents
#s 24, 25, 26, and 11, are in and of themselves sufficient to establish a failure by
Petitioner to comply with the regulation’s requirements. Petitioner’s staff developed care
plans that reflected the staffs assessments of these dependent residents’ vulnerabilities.
The interventions stated in the plans — including repositioning the residents every two
hours — had been determined by the staff to be essential to assuring that these residents
not develop pressure sores. Failure by the staff to implement the care plans constituted a
failure to take all reasonable measures to protect the residents.

Similarly, the facts relating to Residents #s 33 and 39 would be sufficient if not rebutted
to prove that Petitioner failed to satisfy regulatory requirements. Neither of these
residents was identified by Petitioner’s staff to be particularly vulnerable to developing
5

pressure sores. Yet both of them developed sores, and indeed, Resident # 33 began
showing signs of sores the day before Petitioner’s staff assessed the resident as being at
low risk for the development of pressure sores. There is a presumption built into the
regulations that pressure sores in nursing facilities are avoidable. See 56 Fed. Reg.
48826, 48851 (September 26, 1991).' It is incumbent on Petitioner to explain why these
two residents developed sores in spite of its best efforts to protect them. Petitioner must
e found to be deficient in providing care absent facts to show that the sores were
unavoidable.

conclude that Petitioner did not rebut CMS’s assertion of facts and arguments.
Petitioner contends that there are disputed material facts concerning its compliance.
However, Petitioner has not challenged any of the facts that are elements of CMS’s case.
t alleges additional facts which it contends rebut those offered by CMS. For purposes of
this decision, I have assumed that all of the facts alleged by Petitioner are true. But the
facts alleged by Petitioner do not create a genuine dispute about material facts even
assuming that they are true.

First, Petitioner asserts that the medical records for Residents #s 24, 25, 26, and 11
“clearly document that . . . [each] resident was being turned and repositioned every 2
ours on a daily basis, including on September 13, 2007.” Petitioner’s response to
CMS’s motion (response) at 4, 5. In fact, Petitioner has not offered any facts from which
might reasonably infer that the four residents whose care is at issue were repositioned
during the period when they were being observed.

' The preamble to the final regulations state—

Comment: One commenter concurred with the requirement in § 483.25(c)
which requires that a resident with pressure sores receive necessary
treatment to promote healing and prevent infection or the development of
new sores. Two others requested that § 483.25(c)(2) be revised, allowing a
facility to be exempted from this requirement by claiming that a resident's
clinical condition makes such treatment impossible.

Response: We are not making the requested revision because we believe
that the facility should always furnish the necessary treatment and services
to prevent the development of pressure sores or, at the least, to promote the
healing of sores that have developed.
6

No employee of Petitioner has averred that he or she repositioned the residents during the
time period on September 13, 2007 when the surveyors observed them to be on their
backs continuously. Petitioner has offered no witness statements to challenge any of the
surveyors’ findings about these residents. Nor has Petitioner produced any
documentation that specifically shows that residents were being repositioned during the
period when they were observed by the surveyors to be lying continuously on their backs.
For Resident # 11, Petitioner produced an hourly repositioning schedule for the period
from September 14 through 24, 2007. Those are dates that are after September 13, the
date when the surveyors made their observations of this resident. The document thus says
nothing about what happened on September 13.

The other documents that Petitioner relies on are: P. Ex. 78; P. Ex. 79; P. Ex. 82; P. Ex.
85; P. Ex. 87; and P. Ex. 90. These documents consist of activities of daily living flow
sheets that are initialed once per shift. They contain markings from which I might infer
that members of Petitioner’s staff reported having repositioned the residents whose care is
at issue during the work shifts on September 13, 2007 and on other dates. But the most I
can infer from the markings is that the residents were repositioned at some time during a
given shift. I cannot infer anything beyond that because the flow sheets contain no
charting showing when during a shift the residents were being repositioned. There is
nothing in these documents which records the times when residents were repositioned or
even how frequently they were repositioned during a shift.

Indeed, there is nothing inconsistent between the exhibits and the surveyors’ observations
because it is possible that, on September 13, the residents could have been (and in fact,
Residents 26 and 11 were) repositioned during each shift but not at two hour intervals or
during the period when the surveyors saw them lying continuously on their backs.

Petitioner argues also that two of the four residents, Residents #s 26, and 11, were placed
on mattresses known as ASAP II air mattresses. According to Petitioner, the
manufacturer’s instructions for these devices state that their use “may eliminate turning
schedules for pressure considerations.” P. Ex. 70; P. Ex. 71. But assuming that to be
true, it does not derogate from the fact that Petitioner’s staff decided that repositioning the
two residents was a necessary element of their care. The residents’ care plans could have
been amended to show that repositioning was no longer necessary due to the use of the
ASAP II mattress — if staff had concluded that was the case — but they were not. The
only reasonable inference that I can draw is that the staff never decided that the need to
reposition these two residents was eliminated by use of the ASAP II mattress.

Furthermore, there is nothing in the manufacturer’s instructions from which I may infer
reasonably that the use of ASAP II mattresses actually eliminated a need for repositioning
Residents #s 26 and 11. The instructions do not say that use of the mattress will eliminate
7

the need for repositioning. They say only that such use might eliminate such need.
Petitioner has offered absolutely no facts to show that its staff considered these
ambiguous instructions and from them addressed the possibility whether the ASAP II
mattresses given to Residents #s 26 and 11 would eliminate the need to reposition the
residents. Nor has Petitioner offered even a single fact to show that the staff made an
informed judgment that repositioning was no longer necessary with the inception of the
mattresses’ use.

As for the care it gave to Residents #s 33 and 39, Petitioner argues that CMS is now
making allegations that were not made in the report of the September survey. It contends
that the survey report asserts only that Petitioner failed to identify the sores that these
residents manifested. See P. Ex. 3, at 2. Petitioner argues that there are no findings in the
report to the effect that Petitioner failed to protect residents against developing avoidable
pressure sores.

I agree with Petitioner that the report of the September survey does not explicitly allege
that Petitioner failed to protect residents against developing avoidable sores. However,
the facts on which CMS bases this allegation and which I discuss above were stated
explicitly in the September survey report. P. Ex. 3, at 33. Petitioner was on notice of
these facts as of the date it received a copy of that report.

There is nothing in the regulations barring CMS from clarifying or even amending its
determination of noncompliance pending an appeal of its remedy determination. The
only limitations placed on CMS’s ability to clarify or amend are those which are posed by
considerations of due process. CMS is precluded from amending or making new
allegations where to do so would be fundamentally unfair to a facility. Such unfairness
might exist where a facility does not have sufficient notice of the new allegations and an
opportunity to develop its defenses to them.

Here, Petitioner received ample notice from CMS, in its motion for summary disposition,
that it was making the legal argument — based on facts previously disclosed to Petitioner —
that Petitioner had contravened the requirements of 42 C.F.R. § 483.25(c) by failing to
prevent residents from developing avoidable pressure sores. I discern no prejudice to
Petitioner. Petitioner had long been aware of the operative facts and had plenty of time
within which to develop a defense to CMS’s amended allegations of noncompliance.

Petitioner also contends that CMS’s findings of noncompliance concerning the care that
was given to these two residents were stricken at an informal dispute resolution
proceeding. But, in fact, nothing that CMS now alleges concerning the development of
pressure sores by Residents #s 33 and 39 was the subject of the informal dispute
resolution. See P. Ex. 94.
Petitioner has not provided me with anything that might be construed as a defense on the
merits against CMS’s allegations concerning the care that Petitioner’s staff gave to the
two residents. Petitioner has offered no facts to dispute the allegations on which CMS
based its motion. It does not deny that Resident # 33 and Resident # 39 developed
pressure sores while these residents were under Petitioner’s care. Nor does Petitioner
deny that its staff had assessed each of these residents as being at low, or at worst,
moderate, risk for development of pressure sores right up until the sores were first
identified.

Most important, Petitioner has offered no facts whatsoever from which | might infer
reasonably that these residents’ pressure sores were unavoidable. For example, Petitioner
has not even alleged that either of these residents suffered from medical problems that
made the development of sores an inevitable consequence despite Petitioner’s best efforts
to protect them against developing sores. And, furthermore, Petitioner has offered no
legal analysis to suggest that, given the undisputed facts, it is not liable for the
development of sores by the two residents.

b. Petitioner failed to comply substantially with the requirements
of 42 C.F.R. § 483.75.

The regulation at issue here provides in relevant part that a skilled nursing facility must
be administered effectively and efficiently in order to maximize the well-being of each of
its residents. CMS’s allegations that Petitioner failed to comply substantially with this
regulation derive from its assertions of noncompliance that I discuss at subpart a. of this
Finding. According to CMS, when viewed in their totality, the instances of Petitioner’s
noncompliance show that it was not attentive to the key needs of its residents.

I agree with CMS that the undisputed material facts establish a management failure by
Petitioner. I infer from these facts that Petitioner’s staff neither comprehended nor
carried out their responsibilities to protect residents who were at risk for developing
pressure sores. That failure reasonably may be attributed to Petitioner’s management
which had the responsibility for insuring that the staff operated effectively and efficiently
to provide care that satisfied the letter and spirit of the Act’s requirements and those of
implementing regulations.

Petitioner characterizes CMS’s noncompliance allegations as mere “conclusory
sentences.” Petitioner’s response at 7. In saying this, Petitioner seems to be arguing that,
as a matter of law, findings of noncompliance with the administration requirement may
not derive from findings of noncompliance with other regulatory requirements. If this is
Petitioner’s assertion, I disagree with it. The undisputed facts of this case are sufficient
for me to conclude that there was a wholesale failure by Petitioner’s staff to carry out its
9

responsibilities to protect residents who were vulnerable to developing pressure sores.
Indeed, it is not reasonable for me to infer otherwise from the facts relied on by CMS.
The incidences of noncompliance that I discuss at subpart a. of this Finding were not
isolated or random. The undisputed facts establish, rather, a pervasive lack of compliance
by Petitioner’s staff with regulatory requirements. It is only reasonable that I infer that
such a wholesale failure by staff to discharge their responsibilities was caused by a failure
of Petitioner’s management to assure that the staff was sufficiently trained and
appropriately managed to carry out their responsibilities.

Petitioner also makes a series of contentions about the performance of its management.
According to Petitioner:

(1) The Director of Nursing (“DON”) effectively communicated with the
nursing staff with physician order changes; (2) The DON is part of the
weekly QA skin committee and is made aware of changes to resident
wound conditions; (3) The DON implemented the turning & repositioning
schedules for the residents in the facility; (4) The DON and Medical
Director were aware of the wounds as evidenced by the clinical records; and
(5) The Q/A Assessment Committee, DON and other nurse managers
appropriately supervised the nurse staff and provided appropriate oversight
training and guidance reasonably necessary to evaluate the care and
treatment provided to the residents made the subject of the survey.

Petitioner’s response at 8. For purposes of this decision I will assume that all of these
contentions are true. But, assuming that, they beg the question raised by the facts asserted
by CMS because they exalt form over function.

The issue here is not whether there were communications between Petitioner’s nursing
director and staff, whether there were meetings of the quality assessment committee, or
whether the director of nursing issued directives to staff, and conducted oversight. The
issue is whether the management of Petitioner’s facility was effective. The facts offered
by CMS show that regardless of the directives, communications, and meetings that
occurred at Petitioner’s facility there was an obvious failure to implement residents’ care
plans and a failure by Petitioner’s staff to take appropriate measures to protect residents
from developing pressure sores. That failure is ultimately a failure of management
because it is a facility’s management’s responsibility to assure that the staff execute their
responsibilities effectively.
10

lam not suggesting that every error or mistake by a member of a facility’s staff translates
to a failure of that facility’s management to discharge its responsibilities effectively.
There are times when errors occur despite the best efforts of a facility’s management. But
here, the undisputed facts show such a pervasive noncompliance that it is simply not
reasonable to infer that the noncompliance was a random event that occurred despite
effective management.

Petitioner also cites a series of its exhibits as support for its contention that it was
effectively managed. Petitioner’s response at 8; see P. Ex. 91 - P. Ex. 98. Petitioner has
not told me what is in these exhibits that support its contentions. Nevertheless I have read
them. The exhibits comprise: records of in-service training; a note from a physician;
attendance records for Petitioner’s quality assessment committee meetings; the findings
of the Texas Health and Human Services Commission concerning Petitioner’s informal
dispute resolution hearing; affidavits from members of Petitioner’s staff and a consultant;
and Petitioner’s request for informal dispute resolution. I cannot discern anything in
these exhibits that creates a dispute as to the material facts relied on by CMS to establish
Petitioner’s failure to be managed effectively.

Some of these exhibits appear to be irrelevant on their face. For example, P. Ex. 92 is a
statement from a physician about a resident whose care is not the subject of CMS’s
motion. Petitioner has offered no explanation of why this exhibit raises material facts.
Others are merely evidence that Petitioner maintained the forms of management but raise
no facts to challenge CMS’s evidence showing that Petitioner was managed ineffectively.
For example, P. Ex. 93 consists of attendance records of Petitioner’s monthly quality
assurance meetings. The exhibit contains no information concerning what decisions were
made at these meetings.

2. CMS’s remedy determinations are reasonable.

At issue here are two per-instance civil money penalties: $4,000 that CMS determined to
impose to remedy Petitioner’s failure to comply with the requirements of 42 C.F.R.

§ 483.25(c); and $6,000 that CMS determined to impose to remedy Petitioner’s failure to
comply with the requirements of 42 C.F.R. § 483.75. I find that the undisputed material
facts establish these two remedies to be reasonable.

Per-instance civil money penalties are authorized by 42 C.F.R. § 488.438(a)(2). This

section provides that penalties which are imposed for an instance of noncompliance shall
fall within a range of from $1,000 - $10,000 per day. The criteria for determining where
within this range a per-instance civil money penalty should fall are set forth at 42 C.F.R.
11

§§ 488.438(f)(1) - (4) and 488.404 (incorporated by reference into 42 C.F.R.

§ 488.438(f)(3)). These criteria may include: the seriousness of a facility’s
noncompliance; its compliance history; its culpability for its noncompliance; and its
financial condition. Id.

CMS argues that each of the penalties that it determined to impose is relatively modest.
Respectively, they comprise 40 percent and 60 percent of the maximum allowable per-
instance amount. According to CMS, these relatively modest penalties are amply
justified by the seriousness of Petitioner’s noncompliance.’ It contends that each of the
two deficiencies related to care that Petitioner gave to residents who were either totally
dependent on Petitioner’s staff for their daily existence or who were in need of extensive
assistance. These residents’ helplessness, according to CMS, made it critical that
Petitioner’s staff be attentive to their needs. Petitioner’s failure to provide these residents
with the care they needed — literally to survive — put them at grave risk of severe harm.

l agree entirely with CMS’s characterization of the seriousness of Petitioner’s
noncompliance. The seriousness of Petitioner’s noncompliance — in and of itself — amply
justifies the remedies that CMS determined to impose. The undisputed facts show that
residents who were identified by Petitioner’s own staff as being extremely vulnerable to
the development of pressure sores, who were identified also as needing frequent
repositioning as an essential measure to protect against the development of sores, and
who were literally incapable of positioning themselves were left by the staff to lie in one
position for hours. This noncompliance comprised a blatant disregard for these
residents’ most basic needs and its egregiousness was compounded by the fact that it
involved multiple residents.

Perhaps even more appalling was that Petitioner — after having consistently identified two
of its residents as being at low risk for the development of pressure sores — failed to
protect them against developing sores. It is simply not consistent with modern nursing
practice that a facility fail to take adequate protective measures to prevent its residents
from developing avoidable pressure sores. Petitioner’s failure to take such actions in two
instances is an extremely serious episode of noncompliance.

? In the September survey report, the surveyors concluded that Petitioner’s
noncompliance with the requirements of 42 C.F.R. §§ 483.25(c) and 483.75 was so
egregious as to comprise immediate jeopardy for Petitioner’s residents. I am not required
to decide here whether that determination was clearly erroneous because a finding of
immediate jeopardy is not a necessary element in deciding whether a per-instance penalty
is reasonable. 42 C.F.R. § 488.438(a)(2).
12

The evidence also establishes an extremely serious failure of management to assure that
the staff carry out their responsibilities. As I discuss above, at Finding 1.b., the errors and
misfeasance of Petitioner’s staff were not isolated or random. To the contrary, the
undisputed material facts establish a pervasive failure by Petitioner’s staff to attend to
residents’ needs.

I do not find that Petitioner has called into dispute any of the facts relied on by CMS to
support its remedy determinations. Petitioner suggests that CMS’s arguments in support
of its remedy determinations are somehow deficient because CMS has not presented facts
or arguments addressing all of the regulatory factors described in 42 C.F.R. §§ 488.438
and 404. I do not find this argument to be persuasive because its premise is incorrect.
Where facts that relate to even one of the regulatory factors are sufficient to support a
remedy it becomes unnecessary to decide whether there are also facts that might be
relevant to another factor or factors.’

Petitioner asserts that CMS neither provided nor pointed to any evidence in its motion
that Petitioner had a pattern of or repeated compliance problems or any history of having
remedies imposed against it for noncompliance with the requirements of 42 C.F.R.

§§ 483.25(c) and 483.75. Assuming this to be true, however, does not derogate at all
from the facts that CMS offered establishing the seriousness of Petitioner’s
noncompliance, facts which I have concluded are in and of themselves sufficient to
support the remedies that CMS determined to impose.

Petitioner also asserts that its “degree of culpability in this matter is hotly contested and. .
. [Petitioner] believes it is either nonexistent or minimal at best.” Petitioner’s response at
10. However, CMS’s arguments supporting the remedies are not based on Petitioner’s
culpability but on the seriousness of its noncompliance. Furthermore, Petitioner has not
advocated any facts to support its assertion that it has “hotly contested” its culpability.
Making a naked assertion is not sufficient to call into question the undisputed material
facts on which CMS relies.

> Petitioner could have offered facts that related to any of the regulatory factors to
support an argument that there were disputed material facts as to the reasonableness of the
remedy. For example, Petitioner might have offered facts concerning its financial
condition as an effort to show that the penalty amounts were unreasonable. But it failed
to do so and I am not required to defer a decision until after a hearing on the premise that
Petitioner might present relevant evidence at a later date.
13

Finally, Petitioner asserts that CMS has failed to offer any facts that conclusively
establish the relationship between the two deficiencies that are at issue here. I disagree
that such facts are necessary to sustaining the remedies given the seriousness of the
noncompliance. However, I also find Petitioner’s argument to be perplexing inasmuch as
the undisputed facts clearly show that Petitioner’s failure to be managed effectively
relates directly to its failure to protect those of its residents who were vulnerable to
developing pressure sores.

/s/
Steven T. Kessel
Administrative Law Judge