Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

In the Case of: )
)
Universal Healthcare/King, ) Date: May 6, 2008

(CCN: 34-5449), )
)
Petitioner, )
)

-Vv.- ) Docket No. C-06-227

) Decision No. CR1784
Centers for Medicare & Medicaid )
Services. )
)

DECISION

I sustain the imposition by the Centers for Medicare & Medicaid Services (CMS) of
remedies against Petitioner, Universal Healthcare/King (Petitioner or facility) consisting
of the following civil money penalties (CMPs):

+ $4,000 per day for the period of immediate jeopardy, which ran from November
3, 2005 through December 9, 2005; and

+ $300 per day for the period of noncompliance that was not immediate jeopardy,
which ran from December 10, 2005 through January 26, 2006.

I. Background

Petitioner is a skilled nursing facility in King, North Carolina. It participates in the
Medicare program. Its participation in that program is governed by sections 1866 and
1819 of the Social Security Act (Act). It is also governed by regulations at 42 C.F.R.
Parts 483 and 488.
2

Petitioner was surveyed by the North Carolina State Survey Agency (State survey
agency) for compliance with Medicare participation requirements in a complaint survey
that ended on November 22, 2005 (November survey). The surveyors found that
Petitioner had failed to comply substantially with two participation requirements, 42
C.F.R. § 483.25 (Tag F309) and 42 C.F.R. § 483.60(a) (Tag F426), with respect to one of
the residents, “Resident 1.” The surveyors cited both violations at the “G” level of scope
and severity, which indicated an isolated occurrence involving actual harm that does not
amount to immediate jeopardy.

On December 16, 2005, CMS sent a notice letter to Petitioner advising that, as a result of
the deficiencies found at the November survey, CMS was imposing a CMP in the amount
of $250 per day effective November 22, 2005, as well as other remedies that are not at
issue in this appeal. P. Ex. 3; see P. Br. at 2.

The surveyors conducted another survey of Petitioner that ended on December 10, 2005
(December survey). They found that Petitioner was not in substantial compliance with
three participation requirements, 42 C.F.R. § 483.10(b)(11) (Tag F157), 42 C.F.R.

§ 483.13(c) (Tag F224), and 42 C.F.R. § 483.25 (Tag F309), with respect to another
resident who was also identified as “Resident 1.” I note that this resident is not the same
“Resident 1” who was at issue in the November survey. The surveyors cited these three
violations at the “J” level of scope and severity, which indicated an isolated occurrence
that constituted immediate jeopardy to resident health or safety.

Following the December survey, CMS sent Petitioner a notice letter dated December 29,
2005. In this notice, CMS advised Petitioner that it was imposing a CMP in the amount
of $4000 per day effective November 3, 2005 through December 9, 2005, and a CMP in
the amount of $300 per day effective December 10, 2005. CMS advised Petitioner that it
would be disqualified from operating a nurse aide training and competency evaluation
program (NATCEP) for two years as a result of CMS’s finding that Petitioner’s
noncompliance constituted substandard quality of care. CMS’s notice imposed other
additional remedies, which are not at issue here. P. Ex. 4; see P. Br. at 3.

On January 26, 2006, the State survey agency conducted a recertification and revisit
survey of Petitioner. CMS sent Petitioner a notice letter dated February 10, 2006, which
advised Petitioner that it was in substantial compliance with participation requirements,
effective January 26, 2006. P. Ex. 5. However, CMS then sent Petitioner a notice letter
dated February 13, 2006, which was meant to be an “amended letter” to the February 10,
3

2006 notice. P. Ex. 6. In this notice, CMS stated that the January 26, 2006 revisit survey
revealed that Petitioner continued to be out of substantial compliance, and was reducing
the CMP to $50 per day effective January 26, 2006. P. Ex. 6.'

Petitioner requested a hearing, and the case was assigned to me for a hearing and a
decision. I held a hearing on April 24-25, 2007, in Greensboro, North Carolina. At the
hearing, I received exhibits into evidence consisting of CMS Exhibits (CMS Exs.) 1-12,
and 14-16, and Petitioner’s Exhibits (P. Exs.) 1-46. Sharon Myers and Manay Gunter
testified on behalf of CMS. Elizabeth Lancaster, Dr. Richard Aronson, Dr. Sam
Newsome, Annette O’Brien, and Dr. Stephen South testified on behalf of Petitioner.
CMS and Petitioner submitted posthearing briefs (CMS Brief and P. Brief, respectively)
and reply briefs (CMS Reply and P. Reply, respectively).

II. Issues
The issues in this case are:

. Whether there is a basis for the imposition of an
enforcement remedy;

. whether CMS’s finding of immediate jeopardy is
clearly erroneous, and;

' In its posthearing brief, Petitioner stated “[s]ince Petitioner has not appealed the
deficiencies cited following the January 26, 2006 annual survey, or the relatively small
CMP imposed as a result, the inconsistency in CMS’ Notices does not seem to be material
to this appeal.” P. Br. at 3-4 n.3. Consequently, there is no dispute that the end date of
the CMP at issue in this case is January 26, 2006.

On March 14, 2006, the State survey agency conducted a second revisit survey of
Petitioner. On March 21, 2006, CMS sent Petitioner another notice letter, which provided
that, as a result of the March 14, 2006 survey, it was increasing the CMP to $100 per day
effective March 14, 2006. P. Ex. 7. This survey is not at issue, and I do not discuss it in
this decision.

> CMS withdrew its proposed Ex. 13. Transcript (Tr.) 2.
4

. whether the remedies imposed, a CMP of $4,000 per day for
the period of immediate jeopardy, November 3, 2005 through
December 9, 2005, and a CMP of $300 per day for December
10, 2005 through January 26, 2006, are reasonable.

Ill. Applicable Law

Petitioner is a long-term care facility participating in the federal Medicare program as a
skilled nursing facility and in the state Medicaid program as a nursing facility. The
statutory and regulatory 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 of Health and Human Services (Secretary) with
authority to impose CMPs against a long-term care facility for failure to comply
substantially with federal participation requirements.

Pursuant to the Act, the Secretary has delegated to CMS and the states the authority to
impose remedies against a long-term care facility that is not complying substantially with
federal participation requirements. Facilities that participate in Medicare may be
surveyed, on behalf of CMS, by state survey agencies in order to determine whether the
facilities are complying with federal participation requirements. 42 C.F.R. §§ 488.10-
488.28, 488.300-488.335. Pursuant to 42 C.F.R. Part 488, CMS may impose a per
instance or per day CMP against a long-term care facility when a state survey agency
concludes that the facility is not complying substantially with federal participation
requirements. 42 C.F.R. §§ 488.406; 488.408; 488.430.

The regulations at 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. Jd. Pursuant to
42 C.F.R. § 488.301, “(i)mmediate jeopardy means 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.” (Emphasis in original).
Further, “(s)ubstantial compliance means 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.” /d. (emphasis in original).

The regulations specify that a CMP, which is imposed against a facility on a per day
basis, will fall into one of two ranges of penalties. 42 C.F.R. §§ 488.408, 488.438. The
upper range of CMP, from $3,050 per day to $10,000 per day, is reserved for deficiencies
that constitute immediate jeopardy to a facility’s residents, and in some circumstances, for

5

repeated deficiencies. 42 C.F.R. §§ 488.438(a)(1)(i), (d)(2). The lower range of CMP,
from $50 per day to $3,000 per day, is reserved for deficiencies that do not constitute
immediate jeopardy, but either cause actual harm to residents, or cause no actual harm,
but have the potential for causing more than minimal harm. 42 C.F.R.

§ 488.438 (a)(1)(ii).

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 F.2d 678 (8" 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), 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 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), (d)(10)(i).

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. Thompson, 363 F.3d 583 (6" Cir. 2003). The Departmental Appeals
Board (the Board) 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).

The Act prohibits approval of a NATCEP at any facility participating in the Medicare
program “which, within the previous 2 years — . .. has been subject to an extended (or
partial extended) survey,” which would be triggered by any finding of substandard quality
of care. Section 1819(f)(2)(B)(iii)(1) of the Act; see also section 1919(f)(2)(B)(iii)(1) (the
same provision for facilities participating in the Medicaid program).

When a penalty is proposed and appealed, CMS must make a prima facie case that the
facility has failed to comply substantially with federal participation requirements. “Prima
facie” means that the evidence is “[s]ufficient to establish a fact or raise a presumption
unless disproved or rebutted.” Black’s Law Dictionary 1228 (8" ed. 2004); see also,
6

Hillman Rehabilitation Center, DAB No. 1611, at 8 (1997), aff'd, Hillman Rehabilitation
Center v. U.S. Dept. of Health and Human Services, No. 98-3789 (G.E.B.), slip op. at 25
(D.N.J. May 13, 1999). To prevail, a long-term care facility must overcome CMS’s
showing by a preponderance of the evidence. Batavia Nursing and Convalescent Center,
DAB No. 1904 (2004); Batavia Nursing and Convalescent Inn, DAB No. 1911 (2004);
Emerald Oaks, DAB No. 1800 (2001); Cross Creek Health Care Center, DAB No. 1665
(1998) Hillman Rehabilitation Center, DAB No. 1611 (1997).

IV. Findings and Discussion

The findings of fact and conclusions of law noted below in italics are followed by a
discussion of each finding.

A, Petitioner was not in substantial compliance with federal requirements
applicable to nursing homes participating in the Medicare and Medicaid
programs.

1. The facility failed to provide prescribed, scheduled pain management
medication for Resident 1A (R1A) on November 19, 2005, at 5:00 a.m.
(Tags F309 and F426).

The applicable regulation at 42 C.F.R. § 483.25, entitled Quality of Care, provides that
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 comprehensive assessment and plan of care.

42 C.F.R. § 483.60(a) (Pharmacy Services) requires that a facility provide pharmaceutical
services (including procedures that assure the accurate acquiring, receiving, dispensing,
and administering of all drugs and biologicals) to meet the needs of each resident.

This case concerns deficiencies cited by CMS at two different surveys. At the November
22, 2005 survey, the surveyors cited deficiencies under Tags F309 and F426 with respect
to Resident 1.’ At the December 10, 2005 survey, the surveyors cited deficiencies under

Tags F157, F224, and F309 relating to the care and treatment of a different Resident 14

* | will refer to this resident as RIA.

* | will refer to this resident as R1B.
RIA

A summary of the surveyor findings as reflected in the Statement of Deficiencies (SOD)
from the November survey reveals that:

RIA was admitted to the facility on August 18, 1998, with multiple diagnoses of
hyper carbonic respiratory failure, obstructive sleep apnea, cervical stenosis, and
diabetes. Record review of the facility’s Medication Administration Record
(MAR) for R1A, dated November 1, 2005 through November 21, 2005, showed
that on October 22, 1999, a physician had ordered Cafergot pain tablets to be
administered to the resident every day at 5:00 a.m. P. Ex. 1, at 3,5.

The SOD alleges that in an interview on November 21, 2005, R1A stated that he
did not receive Cafergot on November 19, 2005 at 5:00 a.m. RIA related that the
nurse did not have any Cafergot in her medication cart for his headache.
According to R1A, he received Cafergot at 5:00 a.m. each morning after his
continuous positive airway pressure (CPAP) mask was removed. RIA said he had
a headache, and the nurse offered him another type of pain reliever. He told the
nurse that nothing else worked for his headache after the mask was removed. The
resident also stated that he finally accepted another type of pain reliever, and did
not understand why he did not get his regularly scheduled Cafergot until 4:30 p.m.
on November 19, 2005. P. Ex. 1, at 5-6.

According to the SOD, R1A’s MAR contained an order dated November 19, 2005,
to “hold Cafergot for the 5:00 A.M. dose on 11/19/05.” The SOD states that the
nurse’s medication notes on the backside of the MAR indicated that, on November
19, 2005, at 5:00 a.m., “DCN [Darvocet]” was given for “pain,” and it was
described as “effective” and initialed by a nurse. There was nothing written as to
the strength of Darvocet or number of tablets given, or what time it was effective.
The MAR showed further that, on November 19, 2005, at 10:40 a.m., RIA was
given two tablets of Ultram, a pain reliever, for his complaint of headache. The
Ultram was documented as decreasing R1A’s headache at 12 noon on November
19, 2005. P. Ex. 1, at 5.
8

The SOD relates that the surveyors interviewed Nurse #1, who was responsible for
R1A’s care on November 18, 2005, from 7:00 p.m. to 7:00 a.m. According to the
SOD, on November 19, 2005, at 5:00 a.m., Nurse #1 found that Cafergot was not
in the medication cart. She looked in the backup medication room and no Cafergot
was available. Nurse #1 stated that she obtained an order to hold Cafergot until
5:00 p.m. on November 19, 2005. She told Nurse #2 at 7:00 a.m. that more
Cafergot needed to be obtained for RIA. P. Ex. 1, at 6. The SOD also states that
Nurse #1 expected Nurse #2 to obtain more Cafergot and administer the missed
5:00 a.m. dose by mid-morning when the local and facility pharmacies were open.

The SOD recites further that RIA rated his headache on November 19, 2005, as a
“5” on a scale of “1 to 5” (“1” being minimal pain and “5” being most severe
pain), and that he told the nurse that he had to have Cafergot and that nothing else
would work. RIA stated that the alternative pain reliever he took did not help his
headache. He stated that he was “miserable all day” and “finally got relief 2 hours
after receiving the Cafergot at 4:30 PM on 11/19/05.” P. Ex. 1, at 7.

In response to these allegations in the SOD, Petitioner contends in its brief that its staff
responded appropriately to “an ordinary non-emergency operational issue” (P. Br. at 6)
and that its staff “had no regulatory obligation to administer the Resident’s preferred
medication, as opposed to a substitute actually ordered by his physician.” P. Reply at 7.
Petitioner claims that its nurse discovered that Cafergot was not in the medication cart
during the early morning hours of November 19; she “immediately contacted” R1A’s
attending physician (P. Br. at 6); the physician “ordered that the morning dose of Cafergot
be held, and a substitute pain medication be administered while the pharmacy refilled the
order; and the nurse followed the physician’s order.” P. Reply at 7-8; see also P. Br. at 6.

As I discuss below, Petitioner misrepresents the evidence of record in describing the
sequence of events. I find that CMS has made a prima facie showing that Petitioner was
in violation of 42 C.F.R. § 483.25 as a result of Petitioner’s failure to provide Cafergot as
prescribed to RIA. Petitioner has not rebutted CMS’s prima facie case with credible
evidence.

Petitioner would have me believe that its nurse called R1A’s physician prior to 5 a.m. on
November 19, and received a telephone order to hold Cafergot since Petitioner was out of
it, and administered Darvocet instead at the 5 a.m. dosage time.’ See Tr. 89, 93. In

* [harbor serious doubt that a nurse would call the treating physician at such an
early hour of the morning to inform him that staff failed to timely re-order R1A’s pain
medication.
9

support of these assertions, Petitioner points to a document titled, “Nurse’s Medication
Notes” (P. Ex. 20, page 2), and to a copy ofa telephone order dated November 19, 2005
(P. Ex. 21). I note that the pertinent line on the “Nurse’s Medication Notes” (P. Ex. 20, at
2) relating to RIA’s receipt of Darvocet is basically illegible.’ However, based on
Surveyor Myers’ testimony and what is set forth in the SOD, these notes apparently
indicate that Darvocet (“DCN”) was administered at 5:00 a.m. on November 19, 2005, for
“pain,” and was noted as effective. See P. Ex. 1, at 5.

From my review of these medication notes, I myself cannot with any certainty state
whether Darvocet was given on November 19, 2005, and, if so, at what time it was given,
other than that it appears that something was given for “pain” on November 19. P. Ex.
20, at 2. Nevertheless, there is apparently no dispute that RIA was given Darvocet as an
alternative pain reliever. With respect to the November 19, 2005 telephone order, P. Ex.
21, this order has a handwritten note stating “Hold Cafergot for 5 am dose on 11/19.” No
time is stated on this order.

Despite Petitioner’s assertion that the record “clearly shows” that the nurse received an
order for Darvocet from the physician before R1A’s morning medication was due (P. Br.
at 6), there is no documentation in the record to support Petitioner’s alleged version of the
facts or sequence of events. The November 19, 2005 telephone order instructs only that
the 5 a.m. dosage of Cafergot is to be held; it does not mention Darvocet at all.

Moreover, since there is no time stated on the order, it is not clear when this order was
given. Petitioner has offered no evidence to support its claim that the nurse contacted
R1A’s physician before 5 a.m., and received an order before 5 a.m. to administer
Darvocet instead of Cafergot. I note that, interestingly, there is no order for Darvocet,

® At the hearing, the following exchange took place on cross-examination:
Q (Petitioner’s counsel): Directing your attention to the entry for 5 a.m. on
November 19, and the handwriting is — the copying is light, but do you see where

it says a Darvocet was administered at 5 a.m. to Resident [1] on the 19"?

A (Surveyor Myers): Honestly, I can’t read this. But I know he was given a
Darvocet.

Tr. 89.
10

dated November 19, 2005, in the record.’ Furthermore, an order from the treating
physician directing that Cafergot be withheld is not a cure for the facility’s failure to
timely re-order the resident’s medication. It is evident that the Cafergot was not withheld
for a legitimate clinical purpose, but rather as a ploy to legitimize the facility’s failure.

At the hearing, Surveyor Myers testified that she interviewed two nurses that completed
the medication pass for RIA. Tr. 41. According to Surveyor Myers, the first nurse was
not aware of the November 19, 2005 order that Cafergot be held at 5:00 a.m., and the
nurse believed the reason for RIA not receiving Cafergot was because she was out of it.
Tr. 41-42. Surveyor Myers stated that the second nurse she interviewed also was not
aware of the order to hold Cafergot at 5:00 a.m. Tr. 42.

In addition to receiving Darvocet, the record shows that R1A received an additional pain
reliever, Ultram, around 10:40 a.m. According to the nurse’s medication notes, Ultram
was effective in reducing his headache. P. Ex. 20, at 3. I infer that had the Darvocet been
effective in relieving the resident’s headache, the 10:40 a.m. dosage of Ultram would not
have been necessary. In fact it is evident from the record that neither medication was
effective inasmuch as RIA did not experience relief until Cafergot was administered at
approximately 4:30 p.m. on November 19.

According to the SOD, Petitioner’s pharmacist stated that she received a call on
November 19, 2005*, between 10:00 a.m. and 11:00 a.m., from a nurse requesting
Cafergot for RIA.’ See P. Ex. 1, at 6. The pharmacist stated that the nurse did not tell
her that R1A’s Cafergot was needed right away, and had she stated this, she would have
ordered the Cafergot from the local pharmacy, and facility staff could have picked it up

7 Darvocet is one of the medications listed on RIA’s MAR. However, the date
next to Darvocet is “03/18/05,” and the MAR notes that Darvocet was to be given as
needed for pain in R1A’s left hand/arm. P. Ex. 20, at 1. Inasmuch as Petitioner is
claiming that R1A’s physician gave an order for Darvocet on November 19, 2005, the
fact that RIA’s MAR lists Darvocet is irrelevant.

’ November 19, 2005 was a Saturday.

° The SOD states that the pharmacist received a call from a nurse at the facility
requesting Cafergot for RIA on “11/19/95 between 10:00 AM and 11:00 AM.” The “95”
in the date appears to be a typo. P. Ex. 1, at 6.
11

within an hour. See P. Ex. 1, at 6.'° According to the pharmacist, the on-call pharmacist
for the weekend is available by telephone and comes in the late morning, and fills faxed
and telephone medication requests from Petitioner. Then, a courier would deliver the
medications to the facility in the mid to late afternoon of the same day. See P. Ex. 1, at 6-
7.

Iam not persuaded by Petitioner’s efforts to minimize the seriousness of this deficiency
by stating that “[t]he gist of the deficiency is that Petitioner somehow ran out of the
Resident’s favorite pain medication.” P. Br. at 6. Prescription pain medication for the
level of pain described by RIA (level 5 ona scale of | to 5), is not susceptible to being
described as the “resident’s favorite medication.” It is not as if the staff had failed to turn
the resident’s television to his favorite channel. Such loose description of the situation
borders on being flippant. Moreover, it is disingenuous to say that the facility
“somehow” ran out of Cafergot. It is obvious that the facility utterly failed to comply
with its own policies and procedures, which required that medications be re-ordered
“three to four days in advance of need to assure an adequate supply on hand.” CMS Ex.
6, at 7; see P. Ex. 1, at 3, 4.

t is clear that Petitioner’s staff failed to reorder Cafergot in “advance of need,” in
accordance with its policy. Moreover, after discovering that Cafergot was out of stock on
the medication cart, Petitioner’s staff failed to act with a sense of urgency to have
Cafergot replenished. According to the pharmacist, there was a method by which
Petitioner’s staff could have obtained more Cafergot by prompt dispatch. When
Petitioner’s nurse contacted the pharmacist, she could have requested that the order be
expedited, which would have caused the pharmacist to contact the local pharmacy, where
facility staff could then have picked up the Cafergot within an hour. Instead, Petitioner’s
staff waited at least five hours before calling the pharmacist, and then failed to impress
upon the pharmacist that Cafergot was needed right away for a resident.

Further, in reviewing the evidence, I find Petitioner’s alleged version of the sequence of
events unpersuasive. Petitioner has suggested that the physician’s telephone order to hold
the 5:00 a.m. dosage of Cafergot was given prior to 5:00 a.m. on November 19, 2005. I
find this claim to be specious as there is no evidence to support this. I note that staff did
inform R1A that he would not be receiving Cafergot, and, according to him, the
explanation he received was that they were out of the medication. Tr. 39-40; see P. Ex.
25. Further, the two nurses interviewed by the surveyor both stated they were unaware of
an order to hold Cafergot at 5 a.m. Had there been an actual order from R1A’s physician
to hold Cafergot, I would have expected the nurses completing R1A’s medication pass to

'° Petitioner does not have a pharmacy on site. Tr. 43.
12

have been aware of such an order. The simple, unvarnished reason R1A did not receive
Cafergot at 5:00 a.m. is because the facility staff had failed to place a timely order to
replenish the medication.

Moreover, the lack of evidence undermines Petitioner’s unfounded assertion that R1A’s
physician, prior to 5:00 a.m., gave an order to administer Darvocet to the resident. The
record contains no documentation of any physician’s order for Darvocet given on
November 19, 2005. While R1A did receive Darvocet at some point during the morning
of November 19, 2005, the details surrounding the order and when it was administered,
remain vague.

R1A had informed Petitioner’s nursing staff that Cafergot was the only pain medication
that relieved his headache after he came off the CPAP mask. See Tr. 44,97. The record
shows that RIA suffered a headache pain that he would not have experienced, had he
received Cafergot at 5:00 a.m. Petitioner points out that RIA experienced relief after he
received Ultram around 10:40 a.m. However, as stated earlier, the record indicates that
is headache pain decreased — his pain did not go away completely.

Petitioner points out that RIA was a difficult patient, noting his mental health problems,
is obsessive-compulsive disorder, and the numerous complaints he filed with the State.
P. Br. at 5-6; Tr. 96-97. That RIA may have displayed difficult and/or demanding
ehavior is irrelevant to the issues of this deficiency, and I do not address these
arguments.

Because of the facility’s failure to timely re-order Cafergot, and to obtain a refill
expeditiously for RIA after discovering they were out of the medication, RIA
experienced a lengthy period of headache pain. The facts show that his situation was far
from “border[ing] on frivolous.” P. Br. at 1.

Based on the foregoing, I conclude that Petitioner was not in substantial compliance with
42 C.F.R. § 483.25 and 42 C.F.R. § 483.60(a) inasmuch as Petitioner’s facility failed to
provide necessary care and services, as well as pharmaceutical services, to RIA as a
result of its failure to provide him with his prescribed pain reliever, Cafergot, as ordered
y his physician.

2. The facility failed to notify the physician and responsible party of
R1B’s change in condition (Tag F157).

A facility must immediately inform the resident; consult with the resident’s physician;
and if known, notify the resident’s legal representative or an interested family member
when changes occur, including, but not limited to:
13

a. A significant change in the resident’s physical, mental, or psychosocial
status (i.e., a deterioration in health, mental, or psychosocial status in either
life-threatening conditions or clinical complications); 42 C.F.R.

§ 483.10(b)(11)()(B);

b. A need to alter treatment significantly (i.e., a need to discontinue an
existing form of treatment due to adverse consequences, or to commence a
new form of treatment) 42 C.F.R. § 483.10(b)(11)(i)(C).

1B
The deficiencies under Tags F157, F224, and F309 in the SOD from the December 10,
2005 survey all stem from the same facts relating to the care of RIB.

CMS asserts that, based on record review, interviews with Petitioner’s staff, RIB’s
physician, Emergency Medical Service staff, and R1B’s family, Petitioner failed to notify
the physician and responsible party that R1B experienced a significant change in
condition. CMS alleges that Petitioner’s failure constituted a deficiency at the level of
immediate jeopardy, which began on November 3, 2005, and continued through
December 9, 2005. P. Ex. 2, at 4-5.

According to the SOD, R1B was admitted to Petitioner’s facility on July 6, 2004. His
diagnoses included right subdural hematoma, craniotomy, schizophrenia, seizure disorder,
ypertension, and cerebral vascular accident. The Minimum Data Set (MDS) dated
September 16, 2005, revealed that R1B had no short term memory impairment, but had
long term memory impairment. The MDS indicated that RIB was able to make
independent decisions for tasks of daily living, and was independent with activities of
daily living and continent of urine and stool. P. Ex. 2, at 6; see CMS Ex. 7, at 47-51; P.
Ex. 31.

A summary of the surveyor findings as reflected in the SOD reveals that:

In an interview with the surveyor, Nursing Assistant # 4 stated that, on November
3, 2005, between 7:00 a.m. and 8:00 a.m., she found R1B confused and incontinent
of urine. She stated that R1B was pushing a chair and walking around his room
randomly. The nursing assistant said she had never seen him do that before. She
said that he told her that he “did not feel good and was hungry.” The nursing
assistant went to the dining room to get R1B’s breakfast tray and stated

that she
14

found him lying in his bed on his back and his whole body was shaking.
According to the nursing assistant, the resident was talking, but she could not
understand him because he was shaking so much. The nursing assistant took
R1B’s vital signs, and his blood pressure was 190/120. P. Ex. 2, at 6.

In an interview with the surveyor, Nurse # 1, who was responsible for the care of
R1B on the 7:00 a.m. to 7:00 p.m. shift on November 3, 2005, stated that his blood
pressure was “up a little bit.” She said she called the physician (Dr. Newsome),
and told him that the resident was “acting strange, shaking, blood pressure was
elevated and complaining (R1B) that his roommate was tearing his nerves up.”
Nurse # | stated that Dr. Newsome ordered Valium for RIB, and she administered
it at 10:15 a.m. on November 3, 2005. P. Ex. 2, at 8-9.

In another interview, Nurse # | noted that R1B’s blood pressure was 190/120
before he took the Valium at 10:15 a.m. She said that she and the nursing
assistants tried to sit him up in the bed, and he “flopped” back down. P. Ex. 2, at
9.

In an interview with the surveyor, Nursing Assistant # 2 stated that shortly after
3:00 p.m. on November 3, 2005, Nursing Assistant # 1 called her to R1B’s room to
help her move him. Nursing Assistant # 2 found R1B lying horizontally across the
end of his bed with his feet on the floor. She said that he was ‘“unresponsive””’
and his shorts and underwear were down around his feet. Nursing Assistant # 2
said that R1B’s underwear was completely soaked and smelled of urine. She said
that he had never been incontinent of stool or urine in the past.'' She and Nursing
Assistant # | tried to sit the resident up in his bed, but he fell back down. P. Ex. 2,
at 7-8.

Describing the same incident above, Nursing Assistant # | related that she and
Nursing Assistant # 2 were making rounds after coming on shift at 3:00 p.m., and
found R1B lying down horizontally at the foot of his bed with his feet on the floor.
She stated that R1B’s eyes were closed and she could not get him to talk to her.

"' T note that whereas MDS assessments performed in January and April 2005
reflect that RIB was occasionally incontinent (P. Exs. 28, 29), assessments performed in
June and September 2005 show that he was continent of bowel and bladder. P. Exs. 30,
31. It may be that the Nursing Assistant who made the comment was new to the facility,
but nonetheless, the notations in the more recent MDS assessments evince that the
episodes of incontinence experienced by the resident on November 3, 2005, constituted a
change in condition that warranted consideration along with other changes exhibited.
15

Nursing Assistant # 1 said that RIB was “pretty wet.” She noted that his lunch
tray was untouched. The nursing assistant said she told Nurse # | that R1B had
een incontinent of urine and was not responding to her verbally. P. Ex. 2, at 8.

nan interview with the surveyor, Nurse # 2, who was responsible for R1B’s care
on November 3, 2005, from 7:00 p.m. to 7:00 a.m., said Nurse # | told her that
R1B’s blood pressure had been elevated when he was taken to the shower room
that morning. Nurse # 2 said that Nurse #1 told her that the Valium “knocked
R1B] out” and that he had been sleeping all day. She stated that Nursing
Assistant # 5 came to her after taking R1B’s vital signs and reported that he had a

igh temperature. Nurse #2 said she obtained an acetaminophen suppository for
R1B’s elevated temperature. When she prepared to administer the suppository,
she noticed that R1B had been incontinent of stool. P. Ex. 2, at 9-10.

n an interview with the surveyor, Nursing Assistant # 5 stated that she observed
R1B shortly after shift change at 7:00 p.m. on November 3, 2005. According to
er, R1B’s head of the bed was at a 90 degree angle, and he was “slumped down in
the bed,” his eyes were closed, and his face was “red.” P. Ex. 2, at 10.

A family member of R1B was interviewed by a surveyor and stated that the family
was not contacted about R1B’s change in condition during the day on November 3,
2005. The family member stated that they were contacted when R1B was
transported from Petitioner’s facility to the hospital. P. Ex. 2, at 10.

In an interview with the surveyor, R1B’s physician, Dr. Newsome, stated that he
had seen RIB on November 2, 2005, and he seemed fine. Dr. Newsome said he
vaguely remembered a nurse calling on the morning of November 3, 2005,
regarding the resident. He could not recall the conversation with the nurse, but
knew that R1B was agitated with his new roommate. According to Dr. Newsome,
another nurse called him on the evening of November 3, 2005. He remembered it
sounded like R1B was having an ‘““acute episode”’ such as a ‘““stroke.”’ P. Ex. 2,
at 10.

The surveyors found no documentation about R1B in the nurses’ notes for the 7:00
a.m. to 7:00 p.m. shift on November 3, 2005. P. Ex. 2, at 10.

Nursing notes dated November 3, 2005, at 8:45 p.m., stated “Res found
unresponsive! temp 102.4 BP 150/88, 78 [pulse], 18 [respirations]102.4. [Left] side
flaccid. Then notified MD & EMS. Rectal suppository given acetaminophen 650
mg at 2030.” P. Ex. 2, at 8; see CMS Ex. 7, at 107.
16

In an interview with the surveyor, an EMS staff member who transported R1B to
the hospital on November 3, 2005, stated that he observed R1B being
“unresponsive, taking very shallow breaths, and 02 running via nasal cannula.” He
stated that R1B’s “right pupil was 3 millimeters and the left pupil was 10
millimeters and blown (dilated).” P. Ex. 2, at 11.

In another interview with the surveyor, R1B’s physician, Dr. Newsome, said that
he expected nursing staff to check the resident’s vital signs at least every hour for
an acute change. He stated that he would have expected a head to toe and
neurological assessment, and a blood glucose check with results provided to him
within two hours. P. Ex. 2, at 11.

I find that the foregoing facts establish that R1B’s condition deteriorated during the day
on November 3, 2005. His decline was significant enough to require immediate
notification and consultation of his physician, Dr. Newsome, and notification of a family
representative. Although Dr. Newsome was notified on the morning of November 3,
2005, that R1B had undergone a change in condition, he was not subsequently notified of
a deterioration in his condition until 8:45 p.m.'? That notification occurred many hours
after the resident had shown signs of significant decline. The family, on the other hand,
was not notified at all except when the resident was finally sent to the hospital for
evaluation.'* The significance of the failure to notify the family immediately when a
change in the resident’s status occurred cannot be overlooked. Oftentimes it is the
family’s intervention that prompts the facility to provide residents with the necessary
care. In this particular case, I infer that had the family been notified of R1B’s change in
condition on the morning of November 3rd, it is unlikely that he would have been treated
with almost total abandon, as is disclosed by the record before me. Moreover, the staff
would not have been allowed to dismiss the resident’s weakened and unresponsive state
as merely “playing possum.” P. Ex. 2, at 18-19, 20-21.

® Dr. Newsome’s recollection of having been called by the facility staff is vague,
and there is no contemporaneous documentation of any notification of him on the
morning of November 3, 2005, regarding RIB. However, even accepting that there was
notification of the resident’s physician on the morning of November 3rd, (albeit based on
very weak evidence), the evidence that there was more than sufficient reason to contact
him again concerning the resident’s deteriorated condition is robust.

'S RIB later died at the hospital. The hospital death summary indicates more than
one cause of death, with hyperosmolar coma and new onset diabetes type 3 listed as #1,
and #2 on the list, respectively. P. Ex. 38, CMS Ex. 7, at 117.
17

Petitioner argues that its staff assessed R1B often throughout the day. Allegedly, after
Nurse Coburn’s (Nurse #1 in the SOD) morning telephone call to R1B’s physician, and
prior to 8:45 p.m., there were no changes in the resident’s condition during the rest of the
day that would have necessitated further notification of R1B’s physician.

Further, Petitioner relies on the testimony of its expert witnesses, who opined that RIB
did not exhibit any signs and symptoms during the morning and afternoon of November
3, 2005, that could have been viewed as a significant change in condition. Petitioner
asserts that its experts testified that the first significant change in condition experienced
by R1B did not occur until around 8:45 p.m. I disagree. The resident’s state of almost
complete stupor, incontinence, absence of appetite (when he was known to be a goo
eater), and debilitated state did constitute a significant deterioration in the resident’s
condition to warrant notification of his physician.'* Moreover, the facility staff finally
decided to call the treating physician in the evening only after R1B was noted to be
running a high temperature at 8:45 p.m. They also noted him to be unresponsive an
flaccid, but that is the way he had been for several hours prior to 8:45 p.m. on November
3, 2005. Had the staff assessed the resident’s vitals on an hourly basis as expected by Dr.
Newsome, the increased temperature may have been discovered sooner. In fact, it was
the nurse that entered on duty at the 7:00 p.m. shift on November 3rd who realized that
“something was not right” (Nurse #2). P. Ex. 2, at 9. After she was given an oral
briefing regarding R1B’s condition and events of the day, and a nursing assistant reported
to her that the resident had an elevated temperature, Nurse # 2 decided to administer an
acetaminophen suppository. It was at that time, when in the process of administering that
treatment, that she noted R1B to be incontinent, and concluded that something was
wrong. See P. Ex. 2, at 10. The opportunity to assess the resident and realize that the
unresponsiveness he had displayed all day was not a ploy to gain attention was available
to the staff responsible for his care prior to the 7:00 p.m. shift, but they did not avail
themselves of such an opportunity.

Nurse Coburn was R1B’s attending nurse on November 3, 2005, during the 7:00 a.m. to
7:00 p.m. shift. Petitioner asserts that “according to her report, Nurse Coburn personally
assessed [R1B] at least eight times in about twelve hours.” P. Br. at 13. As support for
this claim, Petitioner relies on her written statement dated December 13, 2005 (P. Ex. 42,
at 1-3). I note that this statement is Nurse Coburn’s after-the-fact reconstruction of the
events that took place on November 3, 2005, and thus is deserving of less weight than had
she written it contemporaneously during her shift on November 3. Additionally, a
reconstruction of the events after the facility was cited for noncompliance with

‘4 Tt has been established that notification was not given to the family until the
resident was taken to the hospital. This evidence has not been refuted by Petitioner.
18

participation requirements is no substitute for the contemporaneous notes that should
have been entered in the resident’s chart. In fact, the inference that I draw is that on
November 3, 2005, R1B was not clinically assessed until 8:45 p.m. when he was found to
be running a temperature as was documented in the nurse’s notes.

According to Nurse Coburn’s December 13, 2005 written statement, around 8 a.m. on
November 3, 2005, she went into R1B’s room to give him his medication and he was
dressed and sitting in his chair. P. Ex. 42, at 1. Nurse Coburn stated that the certified
nursing assistant (CNA) who took R1B to the shower room noticed that “he was unsteady
on his feet and shaking.” P. Ex. 42, at 1. A CNA went to get a wheelchair, and another
nurse took R1B’s blood pressure, which was 190/120.'° When asked if he was hurting,
R1B said no. They decided that the resident should go back to his room. Jd.

Nurse Coburn’s statement relates that she contacted Dr. Newsome and told him that
R1B’s blood pressure was elevated, and he was unsteady and shaking.'* Dr. Newsome
told her he had seen R1B the previous night and that he had been very upset over his new
roommate. Pursuant to Dr. Newsome’s instructions, Nurse Coburn administered Valium
to R1B at 10:15 a.m. According to her statement, around 11:30 a.m., Nurse Coburn
passed by R1B’s room, and went in. She woke him up to take his blood pressure, which
was 170/90, and noted that he was sleepy and not shaking. P. Ex. 42, at 1. Nurse Coburn
described R1B as being “very sleepy acting” around 2:00 p.m. when she woke him up to
take his medicine. P. Ex. 42, at 2. According to her statement, around 4:30 p.m., when
she passed by R1B’s room, she saw that he was sitting at the end of his bed with his pants

'S No entry for blood pressure can be found at 8:00 a.m. in the nurse’s notes for
the day in question.

‘6 The SOD notes that the Assistant Director of Nursing (ADON) stated in an
interview with the surveyor that, in the morning hours between 9:00 a.m. and 10:00 a.m.
on November 3, 2005, the nursing assistants were taking R1B to the shower room and he
began “shaking, not acting right and was flushed.” P. Ex. 2, at 34-35. She said that she
asked him if he was hurting, and he said he wasn’t. The ADON said R1B stated he did
not feel well, but had no complaints of pain. The ADON said she told Nurse Coburn to
call RIB’s physician. P. Ex. 2, at 35. She stated that she told the nursing assistants to
take R1B back to his room and lay him down in his bed. The ADON stated that she did
not check back with Nurse Coburn or check on R1B during the rest of the day. P. Ex. 2,
at 35-36.
19

down by his feet. R1B told her he needed to go to the bathroom. Nurse Coburn told him
not to get up because he was too sleepy, and she called the CNA to help clean him up.
R1B lay back down in the bed. Nurse Coburn stated she helped the CNAs get him back
up to a sitting position, and then she left the room to continue doing her medication pass.

According to Nurse Coburn’s statement, at dinner time, the CNAs told her that RIB was
not eating his dinner and that he continued to be very sleepy. Nurse Coburn went into
R1B’s room, and noted that he was very sleepy. She stated he was not shaking. Nurse
Coburn asked him if he wished to eat, and R1B said no. She stated that he drank two
cups of orange soda, and then he fell back asleep. According to Nurse Coburn, “[h]e was
not shaking, resp. were even and not labored his skin was warm and dry to the touch. At
this point I felt he was sleeping soundly from not having much sleep for a couple of days
efore and being so upset over his roommate and having taken the Valium.” P. Ex. 42, at
2.

t is apparent from Nurse Coburn’s after-the-fact statement that her involvement in R1B’s
care consisted mainly of observations of R1B. Her own interview statements also
confirm that she failed to perform assessments of RIB. According to the SOD, Nurse
Coburn stated that she did not do an assessment of RIB. P. Ex. 2, at 43; see P. Ex. 2, at
9. She stated that she “popped her head” in R1B’s room two other times during the
afternoon, but could not remember the time, and that RIB was “breathing and his color
was okay.” P. Ex. 2, at 41. The SOD further notes that when the resident was lying
horizontally at the foot of the bed, and attempts to sit him up were unsuccessful because
he flopped back down, Nurse Coburn stated she left the room and did not take his blood
pressure or do an assessment. P. Ex. 2, at 43.

Nurse Coburn’s observations cannot take the place of performing actual, meaningful
assessments. Had she performed actual assessments of R1B in the true sense of that
word, I would have expected to see documentation in the form of contemporaneous

nursing notes written by her.'”

'T At the hearing, Petitioner’s counsel himself made the comments that “the
documentation in this case is not terrific” and “the nursing notes are not particularly
great.” Tr. 265-66. Petitioner’s witness, Annette O’Brien, agreed with Petitioner’s
counsel’s assessment (“the documentation is just not good”) and commented that the
notes were not contemporaneous. Tr. 265, 268, 271. In his report dated January 13,
2006, Dr. Aronson, one of Petitioner’s expert witnesses, stated that “nursing notes are not
documented early in the day” on November 3, 2005, and that “nursing documentation on
11/3/05 is not satisfactory.” P. Ex. 41. In the absence of nursing notes, Dr. Aronson
indicates that he reviewed other documents. Jd.
20

Petitioner concedes that Nurse Coburn “did not contemporaneously document most of her
observations through the afternoon,” but notes that she did not see anything that she
considered noteworthy. Petitioner states, “one would not expect unremarkable
observations to be documented in such circumstances.” P. Br. at 14 (emphasis included).
A resident that is being closely monitored should be assessed periodically, and the
findings need to be documented, regardless of how remarkable the findings may be.
Merely “eyeballing” a resident is no substitute for a clinical nursing assessment.
Moreover, properly documented unremarkable findings may be as important as positive
findings when the overall clinical picture is being scrutinized for arriving at a diagnosis
and treatment approach. Petitioner’s unsupported assertions ignore accepted standards of
proper nursing practice. Moreover, the nursing staff would not know if the resident’s
condition was remarkable or unremarkable unless they performed proper nursing
assessments, which they did not do. Thus, there is no basis for concluding that R1B’s
condition was unremarkable.

I note that, as recited in the SOD, Petitioner’s Director of Nursing stated in an interview
with the surveyor that she expected the nurses to do an assessment of R1B, continue
monitoring, and document findings in the nurses’ notes. The Director of Nursing stated
that an assessment would include taking R1B’s vital signs, and doing a visual and
cognitive check. She stated that she would have expected a nurse to check R1B’s vital
signs at least two times between 1:00 p.m. and 7:00 p.m. for a change in condition. P. Ex.
2, at 48.

Other than taking R1B’s blood pressure around 11:30 a.m., Nurse Coburn did not take
R1B’s vital signs hourly or at any other time during her shift (according to her own after-
the-fact statement), nor did she instruct the nursing assistants to do so.'* P. Ex. 42.
R1B’s “T.P.R. Chart,” which was used to record his temperature, pulse, respirations,
blood pressure, and weight, does not contain an entry dated “November 3, 2005,” nor any
notations of vital signs for this date. P. Ex. 36; see Tr. 62-63.

Further, Nurse Coburn failed to create any nursing notes with respect to R1B during her
7:00 a.m. to 7:00 p.m. shift. From the interviews the surveyors held with the nursing
assistants, it appears that Nurse Coburn did not even take R1B’s condition seriously.
When the nursing assistants were unable to sit RIB up because he kept falling backward,
and was verbally nonresponsive with eyes closed, Nurse Coburn accused R1B of

'S When interviewed by a surveyor, an EMS staff member who arrived at the
facility on November 3, 2005, at 9:01 p.m. to transport R1B to the hospital stated that it
was his understanding from one of Petitioner’s nurses that R1B had not been checked on
since 11:00 a.m. that day. P. Ex. 2, at 47.
21

“playing possum” and trying to get attention. When the nursing assistants questioned
R1B’s behavior, Nurse Coburn continued to say that he was “faking it.” P. Ex. 2, at 18-
19, 20-21. One can hardly say that Nurse Coburn was closely monitoring and checking
on R1B’s status during her shift. Petitioner’s claim that Nurse Coburn assessed R1B “at
least eight times in about twelve hours” has absolutely no basis in the record.'® Ms.
Coburn’s after-the-fact explanation that she thought R1B was sleeping soundly from not
aving had much sleep for a couple of days, and being so upset over his roommate, and
aving taken the Valium, is unconvincing in view of her comments that the resident was
‘playing possum” and “faking it.” P. Ex. 42, at 2.

n its posthearing brief, Petitioner argues:

[R1B] was not reported to be gasping for breath, bleeding, vomiting,
complaining of pain, suffering the symptoms of some new infection, or the
like. Instead, he was sleepy and lethargic. Significantly, even lay common
knowledge indicates that sleepiness and lethargy can have many causes,
including many that are benign. In this case, the evidence is unrebutted that
the Valium administered to [R1B] commonly causes this effect, and that
this was the intended and expected effect of administering the medication to
[R1B] to address his sleepiness” and agitation.

P. Br. at 30-31.

'° T note that the only place where Petitioner’s staff contemporaneously recorded
some information about RIB on November 3, 2005, is in a document titled “Nurses
Report Sheet,” also known as a “24-hour report.” CMS Ex. 7, at 60; see Tr. 122.
According to Surveyor Myers, this is a communication tool used by the nurses to
communicate with the next shift nurse and is not part of a resident’s record or part of the
nursing notes. Tr. 122-23, 124, 127. Surveyor Myers testified that she looked at this
document, and it showed some blood pressure notations for R1B, without any
corresponding times. Tr. 125; see CMS Ex. 7, at 60. Surveyor Myers stated that this
document was the only place where she was able to obtain any information about R1B.
Tr. 126; see CMS Ex. 7, at 60.

> Tam puzzled by Petitioner’s suggestion that R1B was prescribed Valium to
address his sleepiness.
22

Petitioner makes much of the fact that each of its expert witnesses testified that the
intended and expected effect of taking Valium, a long-acting drug, would be sedation and
sleepiness. P. Br. at 10. In Petitioner’s view, CMS has chosen to disregard the obvious —
that the drowsiness and lethargy exhibited by R1B were simply induced by the Valium he
was given.

Petitioner’s argument here lacks merit. When facility staff reported to Dr. Newsome on
the morning of November 3, 2005, that R1B was shaking and had elevated blood
pressure, he instructed them to administer the Valium he had prescribed the prior evening
because the resident had been upset about his roommate. For some unknown reason, Dr.
Newsome associated the shakiness and increased blood pressure with R1B’s unhappiness
with his roommate. As has been pointed out, Dr. Newsome prescribed the lowest dosage
available in the hope that the resident would calm down. Thus, 2mg. of Valium for a 210
lb., ambulatory 69-year-old resident (see Tr. 254, P. Ex 31) who required minimal
assistance with activities of daily living, was not intended as a chemical restraint. The
anticipated result was not that R1B would be totally unresponsive and “knocked out.”
Moreover, Petitioner’s experts’ testimony that the staff could have reasonably concluded
that sedation and sleepiness was caused by the Valium administered to the resident is not
persuasive. It was not appropriate for the nurse to surmise that Valium, either singly or in
combination with other medications or because he was sleep deprived, would cause him
to lose appetite, become incontinent, and unresponsive. The nursing staff had a duty to
periodically assess the resident and notify the treating physician of the resident’s
significant change. Only by conducting proper assessments and notifying the physician
could a determination be made as to the underlying cause of R1B’s altered state. That
determination could not have been made by merely “eyeballing” the resident or
construing him to be a “fake.” The clinical conclusions arrived at by a medical expert
testifying at the hearing are not available to the nursing staff caring for a resident who
presents himself with a sudden change in condition in real time. Additionally, any
rationale that the nursing staff may have for following a particular course of action must
be documented in the nursing notes. Such explanations in the aftermath, are of little
probative value.

When R1B spoke to the Social Services Director, Ms. Lancaster, around 7:15 a.m. that
morning regarding his roommate problem, he was “calm, alert... answered questions
appropriately . .. seemed normal as usual with no apparent confusion.” P. Ex. 42, at 4;
see Tr. 165-68. However, when he was being taken to the shower room around 9:30 a.m.,
R1B exhibited unsteadiness on his feet, shakiness, and high blood pressure. Thus, it is
evident that RIB was already manifesting signs of debilitation. These symptoms,

which led to Nurse Coburn’s notification of Dr. Newsome on the morning of November
3, 2005, obviously cannot be attributed to Valium, which R1B did not receive until
23

around 10:15 a.m?’ The Valium that was afterwards administered may have compounded
the underlying problem, and even clouded, the clinical picture, but was not the cause of
the signs and symptoms that prompted notification of the treating physician.

Dr. Newsome, R1B’s physician, stated in an interview with the surveyor that 2 mg. of
Valium was not likely to make R1B unresponsive. P. Ex. 2, at 50. Consistent with that
opinion, at the hearing, he testified that the two milligrams of Valium he prescribed was a
“small dose” Tr. 214. Dr. South, Petitioner’s expert witness, expressed the opinion that
two milligrams is a “modest dose.” However, he added that one milligram is a “low”
dose and five milligrams is a “modest” dose. Tr. 304. Based on that scale, two
milligrams would fall in the low end of what constitutes a small dose, which is in keeping
with Dr. Newsome’s opinion.”

Notwithstanding his opinion that two milligrams was a small dose, Dr. South felt that two
mg. of Valium would have justified the kind of lethargy and sleepiness exhibited by
RIB.” As stated earlier, Dr. Newsome, the treating physician, held a differing view
inasmuch as he told the surveyor that 2 milligrams of Valium was not likely to make RIB
unresponsive. According to Nurse O’Brien, “the peak of [the Valium] would probably be
three hours, and the maximum benefit of the Valium then would decline if it’s an every
six-hour medication.” Tr. 264.

Petitioner asserts, moreover, that R1B’s baseline condition did not change until around
8:45 p.m. on the day in question, when Petitioner’s staff found him unresponsive, flaccid
on his left side, and with a temperature of 102 degrees, and called his physician and 911.
As for R1B’s condition during the day, Petitioner argues that R1B experienced only
“subtle — i.e., insignificant — signs and symptoms that were consistent with his complex
baseline and the expected effects of the Valium.” P .Br. at 31. (Emphasis in original).

*! Dr. Newsome had seen R1B on the night of November 2, 2005, and had written
an order that R1B receive two milligrams of Valium by mouth every six hours as needed
for anxiety. CMS Ex. 7, at 106. R1B’s MAR shows that he did not receive any Valium
on the night of November 2, 2005. CMS Ex. 7, at 110.

» Although Dr. South indicated that he considered one milligram of Valium to be
a low dose, the medical literature reflects that Valium is administered in three dosages:
two mg., five mg., and 10 mg. Physicians’ Desk Reference 1829 (44" ed. 1990).

3 T note that RIB was a 69-year-old male who weighed 210 lbs. Tr. at 254; see P.
Ex. 31.
24

It is true that Resident 1B’s baseline shows an individual with numerous medical
problems. However, based on the record, which includes surveyors’ interviews with
staff, it is evident that R1B exhibited changes in his appearance and behavior during the
day of November 3, 2005, that could be characterized as more than “subtle.” These
changes clearly signaled a deterioration in R1B’s status which triggered Petitioner’s duty
under the regulation to immediately notify and consult R1B’s physician, Dr. Newsome.

One nursing assistant stated in an interview that when she went to R1B’s room shortly
after 3:00 p.m. to help another nursing assistant move R1B, he was lying horizontally
across the end of his bed with his feet on the floor and he was “unresponsive.” P. Ex. 2,
at 7; see CMS Ex. 1, at 2; CMS Ex. 7, at 4. R1B’s shorts and underwear were down
around his feet, and his underwear was urine-soaked. The nursing assistants tried to sit
him up in his bed, but he fell back down, still unresponsive. P. Ex. 2, at 7-8; see CMS
Ex. 1, at 2; CMS Ex. 7, at 4. According to the interview, one of the nursing assistants
told Nurse Coburn about R1B’s condition, and Nurse Coburn chastised R1B for “playing
possum.” Nurse Coburn allegedly told the nursing assistants that R1B’s
nonresponsiveness was a ploy for attention because he did not like his roommate. See
CMS Ex. 1, at 2; CMS Ex. 7, at 4. The nursing assistants noted that Nurse Coburn
walked out of the room and said that R1B was “faking it.” See CMS Ex. 1, at 2.

In another interview, a nursing assistant stated that, around 7:00 p.m., she noticed that
R1B’s head of the bed was at a 90 degree angle and he was “slumped down in the bed,”
his eyes closed and his face was “red.” P. Ex. 2, at 10. These accounts of R1B’s
condition, as related to the surveyors, clearly indicate that he was undergoing a decline in
his condition, and hence, a departure from his baseline status that was sufficiently
anomalous as to necessitate physician notification.

Even Dr. Newsome stated in an interview with the surveyor that he would have expected
nursing staff to have checked R1B’s vital signs at least every hour for an acute change,
and that he would also have expected a neurological evaluation and a blood glucose check
with results provided to him within two hours. P. Ex. 2, at 11. At the hearing, Dr.
Newsome acknowledged having made such statements. Tr. 220-21. However, he then
suggests that his comments to the surveyor were not meant as criticism of the actions the
nursing staff actually did take:

I don’t think that a prudent nurse without the knowledge needed to do anymore
than was done. Looking back, could other things have been done? Sure. But

could/would a prudent nurse have done those beforehand? I don’t think so.

Tr. 221.
25

Dr. Newsome is apparently of the view that there is a justifiable distinction between what
ought to have been done hypothetically by Petitioner’s staff in terms of R1B’s care and
treatment, and what, in fact, occurred with RIB. See P. Reply at 5. However, rather than
acting as a defense of the staff’s actions, his testimony instead puts their actions under a
harsher light. Is Dr. Newsome suggesting by his testimony that RIB was deserving of
less care and less monitoring than what should generally have been given? Frankly, | am
not impressed by Dr. Newsome’s attempt to suggest that he had only been speaking in
hypothetical terms to the surveyor.

The lack of monitoring R1B received was also commented on by Petitioner’s own expert
witnesses. Both Dr. South and Dr. Aronson testified that they would have performed
some testing of RIB during the day. Dr. South stated that he probably would have
ordered “some more lab work” during the morning of November 3, 2005, at the time Dr.
Newsome was called by staff. Tr. 309. In the report he prepared for Petitioner, Dr. South
noted that R1B had had a blood sugar level of 377 on October 11, 2005, and expressed
his opinion that there probably should have been orders to follow up on this with further
testing. P. Ex. 40. Similarly, Dr. Aronson, in his report for Petitioner, stated, “The only
diagnostic intervention that would have potentially changed this course and allowed an
earlier intervention would have been a glucose level and there was no indication for this
in the facility.” P. Ex. 41, at 1. At the hearing, Dr. Aronson testified that he “would have
been a little more concerned about diabetes. I would have initiated some laboratory
monitoring more aggressively from a physician’s standpoint.” Tr. 199.

lam also not persuaded by Petitioner’s argument that, according to its expert witnesses,
no one could have had any inkling that RIB was exhibiting signs of a hyperosmolar
coma. This argument is not relevant to the issue before me. Implicit in the suggestion
that R1B’s condition displayed no red flags at all that would have warranted physician
notification is the assumption that staff was looking out for red flags in the first place, via
monitoring of R1B’s vital signs and other assessments. As the record indicates, there was
no such careful monitoring or assessments of R1B carried out by staff. Given those
circumstances, to say that no red flags were recognized in R1B’s case is both specious
and meaningless.

Along the same lines, Petitioner notes also that Dr. South opined that R1B’s ailment was
irreversible, and that nothing could have been done during the six or seven hours at issue.
Tr. 312; see P. Br. at 20. The assessment of R1B’s survival chances is wholly irrelevant
to the issue of whether Petitioner complied with the physician notification requirement of
42 C.F.R. § 483.10(b)(11). It may be that R1B would have expired no matter what
efforts Petitioner’s staff made on his behalf. But, the fact that he was likely to die
anyway is not a justification for the failure of Petitioner’s staff to discharge its duty to
him. The staff had no way of knowing with any certainty what was likely to happen to
26

R1B on November 3, 2005. It was obligated to monitor him for any significant clinical
changes, and notify his physician immediately about those changes so that a medical
evaluation could be made.

I find that R1B exhibited significant signs of decline during the day on November 3,
2005, prior to 8:45 p.m., and these signs were warnings that physician intervention was
required. Petitioner failed to fulfill its regulatory duty to immediately notify and consult
R1B’s physician and notify a family representative of R1B’s deteriorating status, in
violation of 42 C.F.R. § 483.10(b)(11).

In view of the foregoing, it is my finding that CMS has established a prima facie case that
Petitioner was in violation of 42 C.F.R. § 483.10(b)(11). Petitioner has not overcome
CMS’s showing by a preponderance of the evidence.

3. Petitioner failed to comply substantially with the requirements of 42
C.F.R. § 483.13(c) (Tag F224).

The regulation at 42 C.F.R. § 483.13(c) provides:

The facility must develop and implement written policies and procedures that
prohibit mistreatment, neglect, and abuse of residents and misappropriation of
resident property.

Under this alleged deficiency, which arises under the same facts related above under Tag
F157, CMS contends that Petitioner neglected to assess, monitor, and notify R1B’s
physician of his significant change in condition. CMS alleged that this deficiency was at
the immediate jeopardy level. P. Ex. 2, at 14-27.

CMS submitted into the record Petitioner’s Abuse and Neglect Prohibition Policy, which
states the following:

Each resident has the right to be free from mistreatment, neglect, abuse,
involuntary seclusion and misappropriation of property.

set

Neglect means failure to provide goods and services necessary to avoid physical
harm, mental anguish or mental illness.

CMS Ex. 6, at 1. (Emphasis in original).
27

I note that Petitioner’s definition of “neglect” matches the definition of “neglect”
contained in 42 C.F.R. 488.301:

failure to provide goods and services necessary to avoid physical harm, mental
anguish, or mental illness.

As [have discussed above, Petitioner’s staff failed to monitor and assess R1B during the
day on November 3, 2005, thus allowing his decline to go unchecked. Petitioner’s failure
to provide R1B with the care and services he needed in the face of his deteriorating status
constitutes neglect, in violation of 42 C.F.R. § 483.13(c). Moreover, Petitioner’s failure
to carry out its affirmative duty under the regulation to immediately notify and consult
with R1B’s physician and notify his family representative when he exhibited signs of
decline during the day, also constitutes neglect.

4. Petitioner failed to comply substantially with the requirements of 42
C.F.R. § 483.25 (Tag F309).

The regulation at 42 C.F.R. § 483.25 provides:

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 comprehensive assessment and
plan of care.

Under this alleged deficiency, which arises under the same facts related above under Tag
F157, CMS contends that Petitioner failed to provide the necessary care and services to
R1B, who had a significant change in condition, by failing to assess and monitor physical
and neurological changes. CMS alleged that this deficiency was at the immediate
jeopardy level. P. Ex. 2, at 27-53.

To attain or maintain his highest practicable physical, mental, and psychosocial well-
being, R1B required an attentive staff who recognized his signs of deterioration during
the day of November 3, 2005, and reported these changes in his condition to his
physician. Inasmuch as I have found that Petitioner violated 42 C.F.R. § 483.10(b)(11)
and 42 C.F.R. § 483.13(c), I find that Petitioner also failed to provide him the care and
services that he needed and therefore violated 42 C.F.R. § 483.25.
28

B. CMS’s finding of immediate jeopardy was not clearly erroneous.

CMS determined that the deficiencies under Tags F157, F224, and F309 presented
immediate jeopardy to RIB. 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. Thompson, 363 F.3d 583 (6" Cir. 2003).

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. 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); Florence Park Care Center, DAB No. 1931, at 27-28 (2004), citing Koester
Pavilion, DAB No. 1750 (2000).

Petitioner’s failure to monitor and assess R1B during the day on November 3, 2005, and
its failure to immediately notify and consult his physician and to notify his family
representative of the signs of his deteriorating condition jeopardized the resident’s health
and life. Moreover, Petitioner should have foreseen that a failure to appropriately
monitor and assess the resident for significant changes in his condition as well as the
failure to notify and consult with his physician and notify his family was likely to cause
serious injury, harm, impairment, or death. CMS’s immediate jeopardy determination for
each of the three deficiency tags at issue, Tags F157, F224, and F309, is therefore not
“clearly erroneous.”

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

The burden is on Petitioner to produce evidence that it corrected its deficiencies sooner
than January 26, 2006. Petitioner has produced no such evidence, and in fact, does not
dispute the period of the CMP at issue.

Having found a basis for imposing a CMP, I now consider whether the amount imposed is
reasonable, applying the factors listed in 42 C.F.R. § 488.438(f). Emerald Oaks, DAB
No. 1800, at 10 (2001); CarePlex of Silver Spring, DAB No. 1683, at 16-17 (1999);
Capitol Hill Community Rehabilitation and Specialty Care Center, DAB No. 1629
(1997).
29

CMS imposed a CMP in the amount of $4,000 per day from November 3, 2005 through
December 9, 2005 (immediate jeopardy period), and a CMP in the amount of $300 per
day from December 10, 2005 through January 26, 2006. See P. Ex. 6; P. Br. 3-4. In the
notice of remedies sent by CMS on December 29, 2005, Petitioner was advised that, in
imposing the CMP, the factors identified at 42 C.F.R. § 488.438(f) were considered.
CMS Ex. 11, at 6. Aside from its claims regarding compliance, Petitioner offers no
argument as to the reasonableness of the CMP amount, stating only that the CMP is “in
excess of $160,000, a substantial amount for any nursing facility.” P. Reply at 9. Thus,
Petitioner has not refuted the reasonableness of the CMP.

I determine whether the amount of a CMP is reasonable by applying 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 42 C.F.R. § 488.404 include: 1) the scope and severity of
the deficiency; 2) the relationship of the deficiency to other deficiencies resulting in
noncompliance; 3) the facility’s prior history of noncompliance in general and
specifically with reference to the cited deficiencies.

I have before me no evidence regarding facility history or financial condition. With
respect to the other factors, however, I find that the deficiencies were serious.
Petitioner’s staff jeopardized R1B’s health and safety by failing to monitor and assess the
resident’s condition and by failing to notify and consult with his physician and notify his
family representative of his decline in status during the day on November 3, 2005. For
this, Petitioner was culpable. I therefore find reasonable the amount of the CMP.

D. Petitioner was properly subject to the prohibition on conducting a NATCEP
for two years.

In addition to the CMP, I conclude that the State survey agency was required to prohibit
Petitioner from conducting a NATCEP for two years. Pursuant to section
1819(f)(2)(B)(ii)(1)(b) and (c) of the Act and 42 C.F.R. § 483.151(b)(2) and (e)(1), a
state may not approve and must withdraw any prior approval of a nurse aide training and
competency evaluation program offered by a skilled nursing or nursing facility that: (1)
has been subject to an extended or partial extended survey under sections
1819(g)(2)(B)() or 1919(g)(2)(B)(i) of the Act; (2) has been assessed a CMP of not less
than $5,000; or (3) that has been subject to termination of its participation agreement,
denial of payment, or the appointment of temporary management. CMS imposed a CMP,
the total amount of which satisfies the regulatory requirement, thus triggering the two-
year prohibition in this case.
30

V. Conclusion

For all of the reasons discussed above, I uphold CMS’s determination that, from
November 3 through January 26, 2006, Petitioner was not in substantial compliance with
program participation requirements. I also find that, from November 3, 2005 through
December 9, 2005, Petitioner was not in substantial compliance at the immediate
jeopardy level. I sustain, as reasonable, the $4,000 per day CMP for the period of
immediate jeopardy. I also sustain, as reasonable, the $300 per day CMP imposed from
December 10, 2005 through January 26, 2006.

/s/
Jose’ A. Anglada
Administrative Law Judge