Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

)
In the Case of: )
) Date: October 19, 2007

Ottumwa Good Samaritan Center )
(CCN: 16-5211), )
)

Petitioner, ) Docket No. C-04-363

) Decision No. CR1677
v. )
)
Centers for Medicare & Medicaid )
Services. )

DECISION

Petitioner, Ottumwa Good Samaritan Center, violated 42 C.F.R. § 483.25(i)(1) in the case
of five residents by failure to ensure adequate nutrition as alleged by the Centers for
Medicare & Medicaid Services (CMS) based on the survey completed January 16, 2004.
The violations constituted substandard quality of care. Pursuant to the Social Security
Act (Act) sections 1819(f)(2)(B) and 1919(f)(2)(B) and 42 C.F.R. §§ 483.151(b)(2) and
(e)(1), and 42 C.F.R. § 483.151(b)(2)(ii1), the state was required to withdraw approval of
Petitioner’s nurse aide training and competency evaluation (NATCEP) program for a
period of two years from the date of the survey.

I. Background

Petitioner is located in Ottumwa, Iowa. Petitioner is certified to participate in the
Medicare program as a skilled nursing facility (SNF) and the lowa Medicaid program as a
nursing facility (NF). The Iowa Department of Inspections and Appeals (the state
agency) conducted an annual survey of Petitioner on January 12 through 16, and 26
through 28, 2004. The state agency issued a Statement of Deficiencies (SOD) dated
February 18, 2004, in which it alleged, based on the annual survey findings, that
Petitioner was not in substantial compliance with Medicare and Medicaid participation

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requirements. One deficiency cited a violation of 42 C.F.R. § 483.25(i)(1)' (Tag F325)
at a scope and severity level of H, which amounts to a finding of substandard quality of
care. Based upon the finding of substandard quality of care, an extended survey was
conducted pursuant to sections 1819(g)(2)(B) and 1919(g)(2)(B) of the Act. Pursuant to
42 C.F.R. § 483.151(b)(2)(ii1), Petitioner is prohibited from operating a NATCEP for two
years due to the extended survey. Joint Stipulation (Jt. Stip.).?

Pursuant to 42 C.F.R. § 498.3(b)(16), Petitioner may request a hearing before an
administrative law judge (ALJ) to challenge the finding that it delivered a substandard
quality of care and the resulting loss of authority to conduct a NATCEP. Petitioner was
notified by the state agency, not CMS, that its NATCEP would have to be terminated due
to the findings of the January 2004 survey.’ Jt. Stip.; Tr. 38-39; P. Ex. 11. However,
Petitioner requested a hearing before an ALJ by letter dated May 28, 2004. The case was
assigned to me for hearing and decision on June 24, 2004. A hearing was conducted in
Des Moines, Iowa on November 4, 2004. CMS offered exhibits (CMS Exs.) | through 4

' All references are to the revision of the Code of Federal Regulations (C.F.R.) in
effect at the time of the surveys, unless otherwise indicated.

? This is a “Tag” designation as used in the State Operations Manual (SOM),
Appendix PP — Guidance to Surveyors for Long Term Care Facilities. The “Tag” refers
to the specific regulatory provision allegedly violated and CMS’s guidance to surveyors.
Although the SOM does not have the force and effect of law, the provisions of the Act
and regulations interpreted clearly do have such force and effect. State of Indiana by the
Indiana Department of Public Welfare v. Sullivan, 934 F.2d 853 (7" Cir. 1991);
Northwest Tissue Center v. Shalala, | F.3d 522 (7" Cir. 1993). Thus, while the Secretary
of Health and Human Services (Secretary) may not seek to enforce the provisions of the
SOM, he may seek to enforce the provisions of the Act or regulations as interpreted by
the SOM.

> Based on the survey findings, CMS had notified Petitioner that if it was not in
substantial compliance on revisit survey, a denial of payment for new admissions (DPNA)
would be imposed. The state agency conducted a revisit survey on March 11, 2004, and
it was determined that Petitioner was again in substantial compliance and the DPNA was
never effectuated.

* The parties agreed at hearing that withdrawal of the approval to conduct a
NATCEP was stayed pending the outcome of this appeal. Tr. 227-28; P. Ex. 11.
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and Petitioner offered exhibits (P. Exs.) 1 through 11, all exhibits were admitted.*” CMS
called one witness, surveyor Denise Gaffney. Petitioner called four witnesses, Karen
Kaiser, R.N., Lisa Matthiesen, R.D., Ayesha Ahmad, M.D., and Peter J. Reiter, M.D.,
F.A.C.P.

Petitioner submitted a post hearing brief (P. Brief) and a post hearing reply brief (P.
Reply). CMS filed a post hearing brief (CMS Brief) but elected not to file a reply brief.

II. Discussion
A. Findings of Fact

The following findings of fact are based upon the exhibits admitted. Citations to exhibit
numbers related to each finding of fact may be found in the analysis section of this
decision if not indicated here.

1. Petitioner is a long-term care facility located in Ottumwa, Iowa that was
authorized to participate in the Medicare and Medicaid programs.

2. The state agency conducted an annual survey of Petitioner’s facility from January
12 through 28, 2004.

3. The state agency determined that Petitioner was not in substantial compliance with
federal program participation requirements, including 42 C.F.R. § 483.25(i)(1)
(Tag F325), and that the violation of 42 C.F.R. § 483.25(i)(1) amounted to
substandard quality of care that triggered an extended survey.

4. The violation of 42 C.F.R. § 483.25(i)(1) involved 5 residents and these 5 residents
were found in a sample of 28 drawn from a total resident population of 138.

> Petitioner objected to the CMS exhibits on the basis that they included
cumulative and irrelevant material. CMS explained that it had merely submitted all
documents produced to it by the state survey agency. Rather than attempt to segregate all
cumulative and irrelevant documents during the hearing, I admitted the entire mass of
CMS documents and have carefully avoided consideration of any irrelevant material in
reaching this decision. Tr. at 21-24.
4

The state agency notified Petitioner that the extended survey required that
Petitioner’s authority to conduct a NATCEP be withdrawn for a period of two
years, but the state also advised Petitioner that it would not withdraw the authority
pending conclusion of any appeal.

On May 28, 2004, Petitioner requested a hearing before an ALJ.

Resident 3 experienced an unplanned weight loss of 11 pounds between November
2003 and January 2004.

Resident 3’s unplanned weight loss was due to intake of inadequate nutrition.
Resident 3’s unplanned weight loss was not unavoidable.

Resident 5 experienced an unplanned weight loss of 14.6 pounds between July
2003 and January 2004.

Resident 5’s unplanned weight loss was due to intake of inadequate nutrition.
Resident 5’s unplanned weight loss was not unavoidable.

Resident 6 experienced an unplanned weight loss of 39.3 pounds between October
2003 and January 2004.

Resident 6’s unplanned weight loss was due to intake of inadequate nutrition.

Resident 6’s unplanned weight loss was not unavoidable.

Resident 12 experienced an unplanned weight loss of 16.6 pounds between July
2003 and January 2004.

Resident 12’s unplanned weight loss was due to intake of inadequate nutrition.
Resident 12’s unplanned weight loss was not unavoidable.

Resident 14 experienced an unplanned weight loss of 20 pounds between
December 2003 and January 2004.

20.

21.

5
Resident 14’s unplanned weight loss was due to intake of inadequate nutrition.
Resident 14’s unplanned weight loss was not unavoidable.
B. Conclusions of Law
Petitioner’s request for hearing was timely and I| have jurisdiction.

CMS made a prima facie showing of a violation of 42 C.F.R. § 483.25(i)(1) (Tag
F325).

Petitioner failed to rebut CMS’s prima facie showing of a violation of 42 C.F.R.
§ 483.25(i)(1) (Tag F325) either by showing by a preponderance of the evidence
that the facility was in substantial compliance or with an affirmative defense.

Petitioner violated 42 C.F.R. § 483.25(i)(1) (Tag F325) by failing to ensure that
Resident 3 maintained acceptable parameters of nutritional status.

Petitioner violated 42 C.F.R. § 483.25(i)(1) (Tag F325) by failing to ensure that
Resident 5 maintained acceptable parameters of nutritional status.

Petitioner violated 42 C.F.R. § 483.25(i)(1) (Tag F325) by failing to ensure that
Resident 6 maintained acceptable parameters of nutritional status.

Petitioner violated 42 C.F.R. § 483.25(i)(1) (Tag F325) by failing to ensure that
Resident 12 maintained acceptable parameters of nutritional status.

Petitioner violated 42 C.F.R. § 483.25(i)(1) (Tag F325) by failing to ensure that
Resident 14 maintained acceptable parameters of nutritional status.

Petitioner’s violations of 42 C.F.R. § 483.25(i)(1) in the case of the five residents
cited as examples by the SOD, presented a pattern of actual harm that amounted to
substandard quality of care that required an extended survey.

Withdrawal of Petitioner's authority to conduct a NATCEP was required by 42
C.F.R. § 483.151(b)(2) and (e)(1).
C. Issues
The issues in this case are:

Whether Petitioner was in substantial compliance with the requirement of
participation set forth in 42 C.F.R. § 483.25(i)(1), Tag F325; and,

Whether, if there was a deficiency, it constituted substandard quality of care as that
phrase is defined in 42 C.F.R. § 488.301.

D. Applicable Law

The Act sets forth requirements for long-term care facility (SNF and NF) participation in
the Medicare and Medicaid programs and authorizes the Secretary to promulgate
regulations implementing the statutory provisions. Act §§ 1819 and 1919. The
Secretary’s regulations governing nursing facility participation in the Medicare program
are found at 42 C.F.R. Part 483. Regulations governing survey, certification, and
enforcement procedures, and regulations governing provider agreements, are found at
Parts 488 and 489, respectively. Regulations governing appeals procedures are found at
Part 498.

To participate in the Medicare and Medicaid programs, facilities periodically undergo
surveys to determine whether they comply with applicable statutory and regulatory
requirements for Medicare (SNFs) and/or Medicaid (NFs). They must maintain
substantial compliance with program requirements, and, 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. Ifa facility is not in
substantial compliance with program requirements, CMS has the authority to impose, in
addition to termination, one or more of the enforcement remedies listed in 42 C.F.R.

§ 488.406, including a denial of payment for new admissions, directed in-service training,
and imposition of a civil money penalty. See Act, section 1819(h).

Scope and severity levels are used by CMS and a state when selecting remedies. The
scope and severity level is designated by an alpha character, A through L, selected by
CMS or the state agency from the scope and severity matrix published in the SOM,
section 7400E. A scope and severity level of A, B, or C indicates a deficiency that
presents no actual harm but has the potential for minimal harm. Facilities with
deficiencies of a level no greater than C remain in substantial compliance. 42 C.F.R.

§ 488.301. A scope and severity level of D, E, or F indicates a deficiency that presents no
actual harm but has the potential for more than minimal harm that does not amount to
immediate jeopardy. A scope and severity level of G, H, or I indicates a deficiency that

7

involves actual harm that does not amount to immediate jeopardy. Scope and severity
levels J, K, and L are deficiencies that constitute immediate jeopardy to resident health or
safety. The matrix, which is based on 42 C.F.R. § 488.408, specifies which remedies are
required and optional at each level based upon the frequency of the deficiency. See SOM,
section 7400E.

A facility has a right to appeal a “certification of noncompliance leading to an
enforcement remedy.” 42 C.F.R. § 488.408(g)(1); see also 42 C.F.R. §§ 488.330(e) and
498.3. However, a facility may not appeal the choice of remedies by CMS or the factors
CMS considered when choosing a remedy. 42 C.F.R. § 488.408(g)(2). In this case, CMS
imposed no remedies. Rather, the survey findings amounted to a finding of substandard
quality of care which triggered the withdrawal of Petitioner’s authority to conduct a
NATCEP.

Pursuant to sections 1819(b)(5) and 1919(b)(5) of the Act, skilled nursing facilities and
nursing facilities may only use nurse aides who have the required training and
competency evaluation. Sections 1819(e) and 1919(e) of the Act impose upon the states
the requirements to specify what nurse aide training and competency evaluation programs
they will approve that meet the requirements established by the Secretary and a process
for reviewing and approving those programs using criteria set by the Secretary. Pursuant
to sections 1819(f)(2) and 1919(f)(2), the Secretary was tasked to develop requirements
for approval of nurse aide training and competency evaluation programs and the process
for review of those programs. The Secretary promulgated regulations at 42 C.F.R. Part
483, subpart D. Pursuant to 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)(i) or
1919(h)(2)(A)(i1) of the Act unless the survey shows the facility was in compliance with
participation requirements; (2) has been assessed a CMP of not less than $5000; or (3)
that has been subject to termination of its participation agreement, denial of payment, or
the appointment of temporary management.

“Substandard quality of care” is identified by the situation where surveyors identify one
or more deficiencies related to participation requirements established by 42 C.F.R.

§ 483.13 (Resident Behavior and Facility Practices), § 483.15 (Quality of Life), or

§ 483.25 (Quality of Care) that are found to constitute either immediate jeopardy, a
pattern of or widespread actual harm that does not amount to immediate jeopardy, ora
widespread potential for more than minimal harm that does not amount to immediate
jeopardy and there is no actual harm. 42 C.F.R. § 488.301. Extended and partial
extended surveys are triggered by a finding of “substandard quality of care” during a
standard or abbreviated standard survey and involve evaluating additional participation
8

requirements. Jd. In this case, the allegation of substandard quality of care is premised
upon the alleged violation of 42 C.F.R. § 483.25 at the H level, i.e., a pattern of actual
harm.

As already noted, a facility is not normally entitled to ALJ review of a CMS or state
agency level of noncompliance determination (also known as the “scope and severity”
determination). The only two exceptions are where the amount of the CMP might be
affected and where there was a finding of “substandard quality of care” that led to loss of
approval of the facilities NATCEP. 42 C.F.R. § 498.3(b)14. In this case, the state agency
made a finding of “substandard quality of care” that led to a partial extended survey and
Petitioner’s loss of approval to conduct its NATCEP.

When a remedy is imposed or there is loss of approval to conduct a NATCEP as in this
case, and there is an appeal, CMS must make a prima facie showing that the facility has
failed to comply substantially with federal participation requirements. 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), aff'd Hillman Rehabilitation Center v. U.S. Dep’t. of Health & Human
Servs., No. 98-3789 (D.N.J. May 13, 1999). A preponderance of evidence is “superior
evidentiary weight that, though not sufficient to free the mind wholly from all reasonable
doubt, is still sufficient to incline a fair and impartial mind to one side of the issue rather
than the other.” Black’s Law Dictionary (7th ed. 1999) (cited by the Departmental
Appeals Board (Board) in Beechwood Sanitarium, DAB No. 1906, at 38 (2004)).

E. Analysis

1. Petitioner received sufficient notice that its authority to conduct a
NATCEP was being withdrawn for two years.

Petitioner argues in its prehearing brief that CMS and the state agency never provided
“appropriate or adequate notice of its intent to prohibit continuation of Petitioner’s
NATCEP program (sic).” Petitioner asserts that the notices provided Petitioner no
“details associated with appeal rights relating to the loss of the NATCEP program (sic).”
Petitioner argues that because it did not receive sufficient notice, approval of its NATCEP
cannot be withdrawn or withheld. Petitioner’s Prehearing Brief at 10-11. In the Joint
Stipulation, paragraph 11, the parties stipulated that “Petitioner has never received a letter
from Centers for Medicare and Medicaid Services (CMS) notifying the facility that the
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findings contained in the statement of deficiencies relating to the January 2004 survey
have resulted in the loss of its NATCEP program (sic).” Petitioner renewed its objection
and argument at hearing. Tr. at 38-39, 41-46. The notice Petitioner did receive was
admitted as P. Ex. 11. Petitioner’s argument is not persuasive.

The Secretary’s regulations, consistent with the Act, put administration of the program for
certification of nurse aides in the hands of the state subject to the regulations the
Secretary promulgates establishing the details for the program. See Act, §§
1819(b)(5)(A)@ A); 1819(b)(5)(C); 1819(£); 1919(b)(S (ADMD; 1919(b)(5)(C); 191 9(f);
42 C.F.R. §§ 483.151; 483.152; 483.154; 483.156. The regulations clearly impose the
duty to provide notice of withdrawal or withholding of approval to conduct a NATCEP
upon the state not CMS. 42 C.F.R. § 483.151(e)(4)(i). Further, the regulation specifies
that the notice from the state must indicate the “reason(s) for withdrawal of approval of
the program.” Jd. The regulation does not specify that the state must notify a provider
that it has a right to appeal the loss of approval or challenge the basis for the action.
Petitioner indicates in its prehearing brief that the state provided it some notice but asserts
the notice is inadequate because it provides no “details associated with appeal rights.”
However, Petitioner does not provide me the notices it did receive so that I might
consider whether or not the notices contained sufficient detail. The stipulation of fact that
Petitioner never received a notice from CMS does not support Petitioner’s position as the
duty to provide notice is upon the state and not CMS. Further, while Petitioner alleges
that the notice from the state was deficient, it is clear that Petitioner was on notice that
approval to continue its NATCEP was withdrawn, the alleged basis for the withdrawal,
and that it could appeal as Petitioner did so.

2. Petitioner violated 42 C.F.R. § 483.25(i)(1) (Tag F325).

Petitioner argues that CMS failed to make a prima facie showing of a violation of 42
C.F.R. § 483.25(i)(1) as to any of the five residents cited as examples in the SOD. In the
alternative, Petitioner argues that the state agency determination of scope and severity
was erroneous and that the alleged violation did not amount to substandard quality of
care.

The regulation requires:

Sec. 483.25 Quality of care. 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.
10

HR KR

(i) Nutrition. Based on a resident’s comprehensive
assessment, the facility must ensure that a resident -- (1)
Maintains acceptable parameters of nutritional status, such as
body weight and protein levels, unless the resident’s clinical
condition demonstrates that this is not possible;

42 C.E.R. § 483.25(i)(1).

The Guidance to Surveyors from the SOM provides that “(p)arameters of nutritional
status which are unacceptable include unplanned weight loss as well as other indices such
as peripheral edema, cachexia and laboratory tests indicating malnourishment (e.g., serum
albumin levels).” SOM, app. P, at PP-106 (June 1995). The SOM also includes an
investigative protocol for unintended weight loss which has two objectives, to determine
if identified weight loss is avoidable or unavoidable and to determine the adequacy of the
facility’s response to the weight loss. The protocol requires surveyors to determine
whether the facility properly assessed a resident for risks for unintended weight loss;
whether the facility assessed the resident’s nutritive and fluid requirements, need for
dining assistance including need for assistive devices, food preferences, allergies, and
frequency of meals; whether there is information or documentation of identified causes
for the weight loss; whether a care plan was developed based on clinical conditions and
risk factors identified by the assessment for the unintended weight loss and whether
interventions were developed; and whether the care plan was evaluated and revised based
on the response, outcomes, and needs of the resident. For a resident in end of life stage,
surveyors are instructed to ensure that palliative interventions in the care plan are
implemented and revised as necessary to meet the needs and choices of the resident and to
maintain the resident’s comfort and quality of life needs. The surveyors are instructed for
all cases of unintended weight loss to make observations to determine whether
interventions have actually been implemented. The protocol states that unintended
weight loss may be found unavoidable if the facility properly assessed, care planned and
implemented the care plan, evaluated outcomes, and revised the care plan as necessary.

If the facility failed to do any of the steps, then the weight loss should be considered
avoidable and the facility cited for violation of Tag F325. SOM, app. P, at P-45 to 46.1
(rev. 10).

The Board discussed deficiency citations under Tag F325 in The Windsor House, DAB
No. 1942 (2004) and Carehouse Convalescent Hospital, DAB No. 1799 (2001). In
Carehouse the Board interpreted the regulation not to require that a facility maintain a
resident’s weight at a fixed level. The Board also determined that a facility is not strictly
liable for a resident’s weight loss. The Board said that the regulation requires
11

maintenance of weight only to the extent that weight is a “parameter of nutritional status,”
1e., if a resident receives adequate nutrition and weight loss is due to non-nutritive
factors, then the weight loss is not a “parameter of nutritional status and the weight loss
alone is not a basis for a deficiency finding.” Carehouse at 21. Nevertheless, the Board
concluded that weight loss raises an inference of inadequate nutrition sufficient to be a
CMS prima facie showing ofa deficiency. Jd. at 22. A prima facie case based upon the
inference arising from weight loss is rebutted if the facility shows by a preponderance of
the evidence that it “provided the resident with adequate nutrition” or weight loss was due
to non-nutritive factors. Jd. In Windsor the Board used the formulation that a “facility is
responsible for taking all reasonable steps to ensure that the resident receives nutrition
adequate to his or her needs.” Windsor at 15. The Board explained that if CMS makes a
prima facie showing based on weight loss, the facility may rebut that showing with
evidence that the resident did receive adequate nutrition or that weight loss was due to
non-nutritive factors, such as the resident’s clinical condition. Jd. The Board commented
that the “clinical condition exception” is a narrow one that applies only when the facility
demonstrates that it cannot provide nutrition adequate for the resident’s overall needs so
that weight loss is unavoidable. Jd. The Board affirmed the ALJ’s findings and
conclusions in Windsor indicating that the ALJ correctly concluded that the presence of a
significant clinical condition alone does not prove that maintaining acceptable nutrition is
unavoidable rather, the ALJ correctly focused upon Windsor’s own assessment of the
residents’ nutritional needs and whether Windsor met its own plan for how to meet those
needs. /d. at 17.

(a) A pattern, sufficient to support a finding of substandard
quality of care, exists where violations are shown in the case of 5
residents from a sample of 28 residents.

CMS alleges, based upon the survey completed on January 16, 2004, that Petitioner failed
to assess and provide and/or implement sufficient interventions for five residents
(Residents 14, 12, 3, 6, and 5), who experienced significant weight loss. CMS Ex. 1, at
39; Tr. at 23. According to the SOD, the surveyors reviewed records for a sample of 28
residents out of a total resident population at the time of the survey of 138. The surveyors
identified 16 residents who had recently experienced significant weight loss and five of
the 16 cases allegedly amounted to violations of 42 C.F.R. § 483.25(i)(1). CMS Ex. 1, at
39. Petitioner argues that even if there are five violations, that number does not constitute
a pattern, and therefore there was no basis for the state agency or CMS to conclude that
there was substandard quality of care. Petitioner’s analysis is that five examples out of
138 does not constitute a pattern because the SOM defines a pattern as more than a few.
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However, Petitioner ignores that the five alleged violations were not found based upon
review of the records of the entire population, but rather a sample of only 28 patients. I
have no difficulty concluding that five of 28 is more than a few residents and a pattern
within the meaning of the SOM.

(b) Petitioner has not proven by a preponderance of the evidence
that it ensured adequate nutrition was received by five residents.

Petitioner does not dispute that for each of the five residents that there was weight loss as
alleged by CMS. Tr. at 33; P. Brief at 11; P. Reply at 1. Based upon the language of 42
C.F.R. § 483.25(i)(1) and the Board’s analysis in Carehouse and Windsor, | conclude that
the admitted weight loss, supported by the clinical records admitted as evidence, are
sufficient to establish a prima facie case of a violation. Contrary to Petitioner’s
assertions, it is not incumbent upon CMS to show Petitioner failed to provide the five
residents adequate nutrition. P. Br. at 8. Rather, the burden of persuasion by a
preponderance of the evidence is upon Petitioner to show it took all reasonable steps to
ensure that the residents received adequate nutrition but that weight loss nevertheless
occurred or that weight loss was unavoidable. To establish that it took all reasonable
steps, Petitioner must show that it complied with regulatory requirements to assess the
residents’ nutritional needs (42 C.F.R. § 483.20(b)), that it care planned to meet the
residents’ nutritional needs and followed the care plan including implementation of
planned interventions (42 C.F.R. § 483.20(k)), and that it reviewed the efficacy of care
planned interventions and revised as necessary (42 C.F.R. § 483.20(k)(2)(iii)). If
Petitioner fails at any step in the process, it cannot show that the weight loss was
unavoidable. Petitioner presented testimony from some of the residents’ physicians who
opined that weight loss was clinically unavoidable based on the residents’ diagnosis and
medical condition. However, as discussed in more detail hereafter, their opinions are
conclusory and, as the Board has previously stated, the presence of a significant diagnosis
alone is not sufficient to establish that weight loss was unavoidable. The physicians’
testimony is also insufficient evidence that Petitioner took all reasonable steps or that
weight loss was unavoidable after Petitioner took those steps, because the physicians
were not regularly present to witness the delivery of care and have insufficient
information regarding whether or not Petitioner implemented all care planned
interventions.

The following brief summary of the evidence related to each resident reveals Petitioner’s
failures with regard to each and shows that Petitioner has not met its burden to establish
that it took all reasonable steps to maintain adequate nutrition.
13

(1) Resident 14.

Petitioner called the resident’s treating physician, Peter J. Reiter, M.D., to testify. Dr.
Reiter testified that he was Resident 14’s treating physician. He testified that Resident 14
suffered from progressive dementia, arteritis, recurring infections, osteoporosis,
diverticulitis, which previously required surgery, and she had been in general decline for
a number of years. She also suffered marked dependent edema which is a swelling of the
lower extremities due to accumulation or retention of fluid. He opined that the edema
was due to her obesity, chronic venous insufficiency, and chronic use of the cortico-
steriod Prednisone to treat her temporal arteritis. He testified that he administered
diuretics and had her elevate her legs to try to minimize the edema. She was hospitalized
from August 3 to 14, 2003 due to a blood borne infection, chronic lung disease and fluid
retention. She had impairment of cognitive function and there was some evidence of
aspiration of food or other materials. Her decline following hospitalization was more
severe and rapid, which he attributed to dementia possibly secondary to Alzheimer’s
disease. He visited the resident on November 24, 2003 and observed a marked
improvement in the edema in her legs from his last prior visit on September 29, 2003. He
opined that the most important factor in her 20 pound weight loss between early October
and early November 2003 was her reduced fluid retention. He based his opinion on the
fact that during this period she was in bed more, off her legs and with them more
elevated, and he was attempting to reduce the amount of Prednisone she was taking. He
explained that elevating the legs more minimizes the impact of gravity, allowing
circulation of the fluid and excretion by the kidneys. He also explained that Prednisone
causes fluid retention and reducing the dose reduces the amount of fluid retained. He
agreed with Petitioner’s counsel that a significant amount of weight loss was due to
mobilization of the resident’s fluid. He opined that it was also clinically unavoidable for
her to have some weight loss based on reduced oral intake due to end-stage dementia. He
explained that dementia caused her to refuse to eat and to choke when she did eat. The
resident’s family had refused any mechanical means for feeding. Thus, he anticipated
that there would be weight loss. He opined that supplements would not be effective to
change her weight loss due to her dementia and the fluid loss. He opined that her weight
loss had no connection to her development of pneumonia and readmission to the hospital
in January 2004. Upon her release in January 2004, she was placed in a hospice program
in which no nutrition was offered other than what she requested. He opined that the
facility offered appropriate nutrition and she took whatever she chose, that her weight loss
was unavoidable, and not a parameter of nutrition. Tr. at 135-45. His testimony is
consistent with his letter dated March 3, 2004, which indicates that when albumin was
measured it was low, consistent with malnutrition. He states that dietary supplements
were not helpful. He attributes her weight loss to mobilization of fluids and poor oral
intake despite interventions. P. Ex. 2, at 1-2.
14

Under most circumstances, I would accept a treating physicians opinion without much
hesitation. However, in this case I find that Dr. Reiter’s opinions are not appropriately
supported. He indicated that he did not see the resident often in the facility. He testified
to seeing her in the facility once in September 2003 and again in November 2003,
although he apparently saw her also in the hospital in between those visits. There is no
indication that he actually observed feeding of the resident at Petitioner’s facility or that
he reviewed Petitioner’s efforts to ensure she received adequate nutrition. He did not
testify that he reviewed her nutrition records or met with the dietician to develop
interventions to address her resistance to feeding and other problems that interfered with
her taking adequate nutrition. Rather, Dr. Reiter opined that the significant 25-pound
weight loss in October and November was attributable to reduced fluid retention. He
attributes the 20-pound weight loss in December 2003 and January 2004 to the fact that
she was terminal. A 25-pound weight loss due to loss of fluids strains credibility, but
CMS did not rebut that testimony and I do not reject it. However, the opinion that the 20-
pound weight loss in December 2003 and January 2004 was acceptable because she was
terminal anyway, is rejected. The fact that the resident was terminal does not relieve
Petitioner of the continuing responsibility to ensure the resident received adequate
nutrition. The focus is not upon whether Dr. Reiter believed that it was unnecessary to
take further steps to ensure adequate nutrition because she was terminal. The focus is
upon whether Petitioner has shown it took reasonable steps to ensure adequate nutrition
was received by the resident, i.e., whether there was assessment, care planning,
implementation of interventions, and evaluation and reassessment of the Resident’s
needs.

A review of Resident 14’s records reveal the following weight loss during a six month
period:

August 2003 192.2 lbs.
September 2003 193 Ibs.
October 2003 195.8 lbs.
November 2003 170.4 Ibs.
December 2003 174.6 lbs.
January 2004 154.2 lbs.
P. Ex. 1, at 19.

Resident 14’s comprehensive care plan dated October 2, 2003, recognized that she had a
problem with nutrition with a goal that she would accept 75 to 100 percent of three meals
daily. The plan specified that meal acceptance and meal intake were to be recorded every
meal. An undated, hand-written note indicates the resident was to receive Ensure, a
liquid supplement, three times per day with meals. P. Ex. 1, at 22.
15

A registered dietician’s note dated December 23, 2003, shows the resident’s weight as
174.6 pounds with 11 percent weight loss in the last 180 days. The dietician noted the
resident was only consuming 42 percent of meals which provided 870 calories and 35
grams of protein. The dietician recommended that the resident have her albumin checked
due to potential for malnutrition. The dietician noted that at her weight, the resident
required 1700 calories and 79 grams of protein. The dietician planned to continue
monitoring to determine whether the resident needed supplements. P. Ex. 1, at 17-18.

A note dated January 5, 2004, reflects that the dietary consultant requested that albumin
level be checked because she was concerned about possible malnutrition. P. Ex. 1, at 23.

Surveyor Gaffney testified that the deficiency was cited in part because Petitioner had
undertaken as part of Resident 14’s care plan to record the resident’s meal intake.
Petitioner failed to consistently record Resident 14’s meal acceptance on the forms at
CMS Ex. 3, at 842-46, which made it difficult to determine the resident’s actual meal
intake. Surveyor Gaffney testified that knowing how much is eaten is important because,
if a resident is not eating sufficiently, the resident is not getting enough nutrition and
changes need to be made to increase caloric intake and avoid malnutrition. Tr. at 60-61.
My review of Petitioner’s records at CMS Ex. 3, at 842-46 reveals that between
September 1, 2003 and January 9, 2004, Petitioner’s staff failed to make any entry to
reflect whether or not the resident had intake for 145 meals.

Lisa Matthiesen, Petitioner’s Director of Dietary Services, testified that the intent in
recording meal intake is to have every meal recorded. However, she testified that even if
every meal is not recorded as in the case of Resident 14, trends may still be identified and
that is helpful information. Tr. at 156-57. She also testified that snacks were sent to the
wings, and if the resident was hungry, food was available. Tr. at 165. Ms. Matthieson
did not testify as to whether or not snacks were actually taken to Resident 14 or whether
there was any offer to assist Resident 14 or any attempt to encourage her to eat snacks.
She did testify that the resident was resistive to feeding. Tr. at 163-65. According to the
resident’s minimum data set (MDS) with an assessment reference date of December 17,
2003, she was totally dependent on staff for eating, transferring, and locomotion on and
off the unit. P. Ex. 1, at 20-21. Thus, there was no way that the resident could obtain a
snack on her own and the presence of snacks on the wings, absent some evidence of staff
assistance, is not evidence that she was presented with nutrition or had any intake of
snacks. The resident lost 20.4 lbs in December 2003 and January 2004. This represented
a 12 percent weight loss in one month and a 20 percent weight loss in 180 days. I was
provided no dietician assessment for the resident’s December to January weight loss nor
do I find evidence that any new dietary interventions were put in place after the October
2003 care plan and the addition of a liquid supplement at that time.
16

CMS established a prima facie case of noncompliance with the requirements of 42 C.F.R.
§ 483.25(i)(1), based on the undisputed fact that there was weight loss. Petitioner has not
met its burden to rebut the prima facie showing by a preponderance of the evidence.
Petitioner did not document meal intake consistently as required by the resident’s care
plan. Petitioner has not offered evidence that snacks were actually provided to the
resident. Petitioner has not shown that interventions were developed to address the
resident’s resistence to feeding. Petitioner has not shown that after October 2003 it took
steps to revise the resident’s care plan and implement interventions to address the
resident’s alleged lack of desire to eat food offered. Petitioner failed to take these
reasonable steps even though there is clear evidence that the dietician was concerned
about possible malnutrition.

(2) Resident 12.

Ms. Matthiesen testified that Resident 12 was assessed as at risk for weight loss and did
sustain a loss between July and August 2003. Her supplements were increased to four
times per day. Petitioner determined that the resident’s protein needs were being met
through her supplement and meals and she had a slight weight gain in the late summer of
2003. The nutrition risk committee assessed her in January 2004. Her physician was
contacted and a speech language pathology assessment was requested to determine
whether a change in texture of her food was required. She was moved to the assisted
dining room for cuing and supervision. Tr. at 167-70.

Resident 12’s MDS with an assessment reference date of November 19, 2003, shows that
she required supervision in the form of oversight, encouragement or cuing with eating at

least sometimes during the seven day MDS evaluation period. CMS Ex. 3, at 869-70; P.

Ex. 3, at 11-12.

The facility’s weight monitoring program recorded the resident’s weights for the seven
month period as:

July 2003 125.4 lbs.
August 2003 115.2 lbs.
September 2003 116.2 lbs.
October 2003 116 lbs.

November 2003 116.2 lbs.
December 2003 115.2 lbs.

January 2004 108.8 lbs.
17

CMS Ex. 3, at 535. The above weights reflected a total weight loss of 13.24 percent in
six months. Consistent with Ms. Matthiesen’s testimony, Petitioner’s records show the
resident lost 10.2 pounds between being weighed in July 2003 and August 2003.
However, she also lost another 7.4 pounds between being weighed in November 2003 and
January 2004. The correlation between changes in Resident 12’s weight and her intake of
nutrition is clear from her clinical record. Unlike the case of Resident 14, Resident 12’s
meal acceptance and intake was recorded with few gaps. CMS Ex. 3, at 864-68. These
records show a decline in consumption from 46 percent on average in July to 36 percent
in August 2003; an increase to 57 percent in September 2003; no record is present for
October 2003; 48 percent consumption was recorded in November 2003; and an average
of 42 percent consumption was recorded in December 2003. Improved intake was
recorded in September but then a decline was recorded in November 2003 with further
decline in December 2003, roughly matching her declines in weight.

Petitioner argues that the weight loss in July and August 2003 was addressed by the
nutrition risk committee and interventions implemented were increasing her supplements;
moving her to the assisted dining room; changing the texture of her food; and obtaining a
speech therapy evaluation. P. Brief at 15-16. Petitioner does not specifically list the
dates of the various interventions or correlate those interventions to the resident’s
fluctuating weights.

A quarterly nutrition note by Margaret Herman, dated September 3, 2003, shows that
Resident 12 lost 10 pounds between being weighed in July and August. She
recommended two interventions, that the resident be weighed in September and that her
four ounces of liquid supplement be increased from three times per day to four times per
day. P. Ex. 3, at 1. A nutrition note dated October 14, 2003, shows that the registered
dietician, Ms. Herman, recommended adding three scoops of protein powder daily to
increase the protein the resident was getting from her intake at meals and her supplement.

The dietician also recommended that Resident 12 be evaluated for the assisted dining
room due to poor intake by mouth. The concern was that the resident required more
protein to help heal a Stage III pressure ulcer. P. Ex. 3, at 4. The next nutrition note is
the quarterly nutrition assessment dated November 20, 2003, and it was done by Ms.
Matthiesen. Ms. Matthiesen recorded that she was unable to determine if the pressure
ulcer had healed as there was no documentation regarding treatment since September 10,
2003, but she recorded that she believed protein intake was adequate to promote healing.
Ms. Matthiesen noted Resident 12 received a regular diet with supplements, and that she
consumed approximately 41 percent of three meals in the main dining room. There is no
indication Ms. Matthiesen was aware of or followed-up on the recommendation of Ms.
Herman from October that this resident be moved to the assisted dining facility. Ms.
Matthiesen also noted that the resident’s weight of 116 pounds had been stable for 180
18

days, which was clearly incorrect, as Petitioner’s records show this resident declined from
125 pounds in July to 116 pounds in November. P. Ex. 3, at 4. Ms. Matthiesen was also
apparently unaware of a progress note dated November 15, 2003, which shows that due to
mental confusion the resident required assistance with eating. P. Ex. 3, at 13. A progress
note dated January 2, 2004, notes that Resident 12’s weight in December was 115
pounds, that her January weight was down to 108.8 pounds, and this was reported to the
resident’s physician who ordered a supplement if the resident desired. However, when
dietary was notified they reported that the resident already had an order for a supplement.
P. Ex. 3, at 14. No follow-up with the doctor is reported. A progress note dated January
3, 2004, shows that a nurse put the resident on a mechanical soft diet and moved her to
the supervised dining room as a matter of “nursing judgment” until the resident could
receive a speech therapy evaluation after noting the resident could not lift a glass and had
difficulty chewing and swallowing. That evening, after the nurse intervened, the resident
reportedly consumed 60 percent of her meal without difficulty. P. Ex. 3, at 14-15. On
January 6, 2004, a speech therapy evaluation documented dysphagia and recommended
that the resident be allowed extra time to eat her mechanical soft diet. P. Ex. 3, at 16.

My review of the resident’s clinical records reveals that the resident was given increased
supplement in September to address weight loss. A protein powder was added in October
to address a serious pressure ulcer. The registered dietician recommended moving her to
the assisted dining room in October but there is no evidence that was done until January
when a nurse took it upon herself to do so as a matter of nursing judgment. When Ms.
Matthiesen reviewed the resident in November, she was unaware of the resident’s weight
loss within 180 days, she did not determine the status of the pressure ulcer, and
apparently did not read the prior dietician note that recommended moving the resident to
the assisted dining facility. When the resident’s physician was called he was unaware the
resident was receiving supplements. Thus, while Petitioner did implement interventions,
it took months to do so.

(3) Resident 3.

Ms. Matthiesen testified that the resident was admitted in November 2003, recovering
from a fractured femur that had been surgically repaired. She testified that following a
surgery it is not unusual for one to lose some weight. The resident’s intake was very
good at 75 to 100 percent, she could make her wants and needs known, she was not
confused but alert and oriented. Petitioner’s staff had no concern for her. However, she
did agree that the resident experienced a significant weight loss that should trigger
interventions. Tr. at 170-78
19

Resident 3 was admitted to Petitioner’s facility on November 12, 2003, to recover from a
ip fracture that was surgically repaired, possibly with a prosthesis. She was reported to
ave no change in her appetite upon admission. She was noted to have edema or swelling

in her left hip and groin, the area of her surgery. P. Ex. 4, at 4-5. Her weight on

admission was 125 pounds. P. Ex. 4, at 1. An initial nutrition note was entered on

November 17, 2003 by Ms. Matthiesen. Resident 3 was approved for regular diet. She

was noted to weigh 125 pounds, with good intake, and that she was nutritionally stable.

P. Ex. 4, at 3. Nurses notes reflect good progress with recovery from surgery. A note

dated December 1, 2003 shows she had her staples removed and that some swelling

remained in the left thigh. P. Ex. 4, at 7. There is no mention of edema in the records I

ave after December 1, 2003.

Petitioner’s records show the following weights for Resident 3:

November 13, 2003 125 lbs.
November 21, 2003 120 lbs.
November 28, 2003 118 Ibs.
December 4, 2003 116 lbs.
December 11, 2003 115.2 lbs.
December 18, 2003 116.2 lbs.
January 2, 2004 114.6 lbs.
January 8, 2004 114 Ibs.

P. Ex. 4, at 23; CMS Ex. 3, at 535. Resident 3’s record of meal acceptance and intake
shows an average intake of greater than 80% in December 2003 and January 2004. I
note, however, that Petitioner’s records are suspect, in their accuracy and I conclude not
credible for this resident. The record of meal acceptance with intake percentages noted,
lists percentages of 75 percent to 85 percent for every meal on December 4 through 6,
2003. P. Ex. 4, at 16. However, nurses notes show that the resident began vomiting on
December 4 and had to be sent to the emergency room at approximately 4:00 p.m. She
returned from the emergency room about 8:00 p.m. There is no indication she had dinner
at the emergency room. The nurse notes also show that she refused lunch on December 4.
She held her morning medication on December 5, 2003 but experienced vomiting at 6:30
a.m. She had some ice cream for lunch. She refused her evening meal on December 6,
2003 but had sips of liquid. P. Ex. 4, at 8-9, 18.

The resident had an unplanned weight loss of 11 pounds between her admission on
November 12, 2003 and January 8, 2004. Petitioner argues that Resident 3 was admitted
to its facility for rehabilitation following hospitalization for a fractured femur, that weight
loss is not unusual following surgery due to build-up of fluids and subsequent reduction
of the edema. P. Br. at 19-20. Petitioner suggests that given the resident’s excellent

20

appetite and good intake, her weight loss was due to reduced edema following surgery.
Absent some expert testimony, I find Petitioner’s suggestion that the 11 pound weight
loss is attributable to resolution of post-surgical swelling is not credible. Further,
Petitioner continued to lose weight even after there were no longer entries in the clinical
record reflecting swelling. The credible answer to why this resident lost weight is likely
in her answer to a surveyor’s interview question in which she stated on January 14, 2003,
the food is good and that she cleaned her plate followed by the comment: “I need more
because look how thin I am.” P. Ex. 4, at 20. Neither the government nor Petitioner
argue that any weight loss was attributable to the resident’s bout of vomiting in early
December 2003. I find no other credible explanations in the record for this resident’s
weight loss of 11 pounds other than the resident’s credible assertion that she simply was
not being provided enough to eat.

(4) Resident 6.

Ayesha Ahmad, M.D. testified that she had been treating physician for Resident 6 since
September 2002. She testified that the resident has a history of Alzheimer’s dementia,
renal-vascular hypertension, a history of transient ischemic attacks (TIAs), coronary
artery disease, chronic renal failure, neuropathy, and a history of aneurysm repair in 2000.
The resident had a dramatic decline due to his dementia in early 2003 with gradual
worsening since. He was placed in hospice care in October 2003 following

ospitalization for a hip fracture, sepsis, poor appetite, and general decline. Dr. Ahmad
explained that moderate to severe dementia can commonly directly affect appetite and in
Resident 6’s case this caused severe anorexia. She was aware that the resident was eating
only 25 to 50 percent of his meals, not drinking much; in November 2003 Petitioner
advised her the resident lost up to 18 pounds; and in January 2004 she was updated that

e lost an additional 7.7 pounds. She believed that hospice provided an aide that assisted
im with eating, she did not state how often, but characterized the aide’s visits as
frequent. Dr. Ahmad testified that she believed supplements were tried and that the
family specified when he was in the hospital that there was to be no tube or intravenous
feeding. She opined that the resident was declining from dementia, recent sepsis and hip
fracture, and a lot of other co-morbidities, and that there was not much else that could

ave been done for him. She also opined that the resident received adequate nutrition and
that his weight loss was not a parameter of nutrition. Tr. at 183-87. Her testimony is
consistent with her letter to the state agency dated March 22, 2004. P. Ex. 6, at 1.

Ms. Matthiesen testified that a nutritional assessment was done in September 2003 at the
ospital (P. Ex. 5, at 5) and that document and others indicated the resident had poor
intake in September 2003. When Resident 6 was transferred back to Petitioner from the
ospital for hospice care, the family wanted comfort measures only (P. Ex. 5, at 2). She
testified that in hospice care he would be offered food, but he would only eat what he

21

wanted. She believed that his weight loss was an expected outcome of his disease
process. Ms. Matthiesen testified that the resident’s records contain almost daily entries
showing the resident refused to eat, including food brought in by the family and ice
cream. Tr. at 194-208.

The following weights for Resident 6, as alleged in the SOD (CMS Ex. 1, at 45-46) or as
found in Petitioner’s records, are undisputed by Petitioner:

August 2003 181.2 Ibs.
September 2003 182.2 lbs.
September 22, 2003 165 lbs.

October 7, 2003 174.8 Ibs.
November 3, 2003 156.4 lbs.
December 1, 2003 150.6 lbs.
January 2, 2004 142.9 lbs.
January 7, 2004 142.9 lbs

P. Ex. 5, at 5, 15; CMS Ex. 3, at 536.

Dr. Ahmad’s note dated June 11, 2003, shows that Resident 6 was admitted to
Petitioner’s facility on April 11, 2003 due to worsening Alzheimer’s dementia. She could
not determine why he progressed so rapidly in the last several months but speculated that
it was possibly a small stroke rather than his depression, which was being treated. She
listed other diagnoses including hypertension, depression, hyperlipidemia, history of
lumbar stenosis with neuropathy in his legs, and degenerative joint disease. P. Ex. 5, at 1.
A nutrition assessment from Ottumwa Regional Health Center, dated September 22,
2003, three days after his admission for the hip fracture (P. Ex. 5, at 9), shows the resident
at approximately 165 pounds with good appetite, he required aspiration precautions, his
dentures presented a chewing problem. However a note indicates, inconsistently, that the
resident was not responsive and the wife reported he was not eating. Laboratory data
showed his serum albumin was low, indicating a poor protein level. The problem listed is
inadequate intake by mouth of less than 50 percent, due to lack of responsiveness. P. Ex.
5, at 5. Dr. Ahmad’s progress note dated September 27, 2003, shows Resident 6 was
admitted to Ottumwa Regional Health Center on September 18, 2003 from Petitioner due
to a fall and a hip fracture that required hip replacement. The note shows the resident was
suffering from pneumonia with spiking fevers for which he was being treated with
antibiotics. He was delirious and hardly eating. Dr. Ahmad records that she counseled
with the family and the decisions were to provide palliative care, to coax him to eat as
much as possible, and transfer him back to Petitioner to die. P. Ex. 5, at 9. Dr. Ahmad’s
note dated October 7, 2003, shows that Resident 6 had been hospitalized for two weeks
after a fall and hip fracture that was surgically repaired. During his hospital stay he
22

developed high temperatures and pneumonia, possibly due to aspiration, that was treated
with intravenous antibiotics. His family requested comfort measures only, and he was
sent back to Petitioner with an order for hospice. The doctor noted that at the facility he
had not had a fever but was hardly moving or doing anything, with good and bad days for
lucidity, and intake of 25 to 50 percent. Her diagnoses included anemia of chronic
disease, chronic renal insufficiency, severe dementia, poor overall function and on
comfort measures only. His prognosis was noted to be poor. P. Ex. 5, at 2.

Petitioner did not provide me with records reflecting meal acceptance or intake for this
resident other than progress notes for the period October 2, 2003 through January 13,
2004. P. Ex. 5, at 16-37. I do not have progress notes for everyday during the period.
Petitioner also did not provide me with any care plan for this resident. Progress notes
show Resident 6 returned to Petitioner on October 2, 2003 and was evaluated by hospice.
The notes show he refused dinner but ate ice cream, ate his medication in apple sauce,
and drank water throughout the evening. I have no progress notes from October 2
through 6, 2003. A note dated October 7, shows he refused dinner but ate ice cream and
drank a soda. On October 8, 2003, he refused food and drink. The note indicates the
speech pathologist said he could swallow with a two to three second delay but does not
say when the pathologist saw him. On October 9, hospice assisted him with breakfast and
he ate nothing. At lunch, he ate some pudding and drank some milk. He ate 20 percent
of his dinner. On October 10, he drank sips of water as offered, ate 20 percent of supper.
On October 11, he refused breakfast, ate lunch poorly but accepted 220 cc of liquids, and
for dinner ate some vegetable soup and other food, drank some water and some milk. On
October 12, he ate 55 percent of his breakfast with staff assistance, for supper he ate some
of the soup reheated from the day before, and around 8:00 p.m. he had ice cream and
drank some water. A progress note from October 13, indicates he ate well for two meals
and about one-third to one-half of his dinner drinking most of his milk and some water.
A note from October 14 shows the resident ate 100 percent of his snack but does not
specify whether the snack was ice cream. The remaining progress notes through January
13, 2004, reflect a similar pattern of poor intake by mouth. A note dated November 3,
2003, states that Resident 6 lost 18.4 pounds in one month and a fax was sent to Dr.
Ahmad. A note dated January 5, 2004, indicates that Dr. Ahmad was notified that
Resident 6 lost 7.7 pounds in December 2003. A note dated January 6, 2004, indicates
that dietary recommendations were received. On January 7, 2004, Resident 6 was taken
to the solarium for the evening meal, and he ate 50 percent followed by eating 100
percent of his snack. A note from January 8, 2004, includes the instruction to have
hospice bring liquid supplements to give with meals. P. Ex. 5, at 16-37.

Petitioner has only produced three notes from its registered dieticians. A note dated
January 7, 2004, titled “annual nutritional assessment,” indicates the resident has had a
5.5 percent weight loss during the past 30 days and he was consuming only 17 percent of
23

a blended regular diet. The dietician ordered on January 6, 2004, that four ounces of
liquid supplement be provided four times per day to aid with nutrition due to open sores
and significant weight loss. She also recommended adding shakes from hospice with
meals to increase calories. The next note dated January 17, 2004, is signed by Ms.
Matthiesen. She notes repeated open sores and poor intake. She notes it is difficult to
determine his estimated intake because he took few meals in the regular dining room,
with “most food eaten brought in by family,” and “fed by hospice.” She notes he is not
consuming enough calories to support healing. Due to difficultly assessing intake, she
ordered additional supplements. The third note dated January 20, 2004, also signed by
Ms. Matthiesen, indicates Resident 6 had significant weight loss since returning on
“October 1 (sic), 2003.” He lost 6 pounds in December 2003, and had a 5 percent weight
loss in 30 days in January 2004. She notes that the resident was addressed at the
December 2003 and January 2004 nutrition committee meetings. P. Ex. 5, at 39-40. The
nutrition risk committee meeting notes for December 2, 2003, show that the resident had
a 6 pound weight loss, loss has slowed, the goal was to maintain, and the recommendation
was to continue to offer foods liked, but there is no indication what those foods were.
CMS Ex. 2, at 37-40; P. Ex. 9, at 5. Notes from the January 2004 meeting, show he lost
another eight pounds, that hospice was in to feed him but he often refused. The plan was
to add supplement, four times a day. P. Ex. 9, at 2.

Petitioner argues, relying largely upon the testimony and statement of Dr. Ahmad, that
Resident 6 was provided with adequate nutrition, but that he suffered from co-morbidities
resulting in his hospice care and refusal to eat, and that made his weight loss clinically
unavoidable. P. Brief at 17-18. Under most circumstances, the opinions of a treating
physician would be given significant weight. However, I decline to give significant
weight to Dr. Ahmad’s opinions that weight loss for this resident was clinically
unavoidable or that Petitioner did all that was reasonable. There is little or no evidence
that Dr. Ahmad spent any time reviewing Petitioner’s care of this resident. Thus, the
evidence does not show she had an adequate basis for her opinions regarding how well
Petitioner attempted to meet the resident’s nutrition needs. The two times Dr. Ahmad
was notified that the resident had continued weight loss, there is no evidence that she took
any action. In fact, her testimony implies that she had all but given-up on this patient.

Based upon all the evidence, I conclude that Petitioner has not shown that it did what was
reasonable to meet the resident’s nutrition needs. I have not received evidence of any
nutrition care planning other than that which I have summarized. Ms. Matthiesen
admitted that she was aware of the nutrition assessment from the resident’s
hospitalization, which indicated a significant nutrition problem. Nevertheless, there is no
evidence that Petitioner’s dietician did any assessment until January 2004, over three
months after the resident’s readmission. The clinical records also reflect no attempt to
use nutritional supplements until January 2004. Petitioner has produced no records of
24

continuing monitoring or assessment during the period from October 2, 2003 through
January 13 or 14, 2004. There are only progress notes showing that meals were offered
with poor results. Contrary to Ms. Matthiesen’s testimony, the progress notes show that
food brought in by the family was rare. Nursing staff made a partial record of intake in
progress notes. I also recognize that the progress notes do show that individual staff
members and hospice staff attempted various techniques to get the resident to eat.
However, the records show a significant delay in assessing this resident’s needs and do
not reflect any care planned interventions to encourage eating other than staffs ad hoc
attempts at coaxing.

(5) Resident 5.

Ayesha Ahmad, M.D. testified that she had been treating physician for Resident 5 since
June 2002. Resident 5 suffered from Alzheimer’s dementia, hypertension, a history of
recurrent urinary tract infections, depression, and she had a history of a hip fracture, a
seizure disorder, and a history of an upper GI bleed in June 2003. Dr. Ahmad opined that
the resident’s dementia and depression caused her anorexia and that her appetite was also
likely affected by the upper GI bleed, which she attributed to a peptic ulcer. She was
advised on July 11, 2003, that the resident had lost 20.2 pounds following a complicated
hospitalization, and the resident was changed to a pureed diet due to difficulty
swallowing. She approved starting the resident on liquid supplement on November 13,
2003. She testified that she could not recall discussing tube feeding with the resident’s
son, but she recalled that she spoke with him during the resident’s June 2002
hospitalization, and she believed that the family wanted only conservative measures. She
agreed with Petitioner’s counsel that the decision to insert a feeding tube was to be made
by the doctor and family, and the decision was not Petitioner’s responsibility. She opined
that other than coaxing the resident to eat there probably was not much that could be
done. She opined that the resident’s weight loss was related to her clinical condition and
that it was unavoidable. She opined that the resident’s weight loss was very likely
unavoidable without extraordinary measures. She testified that the facility provided
adequate nutrition and that the resident’s weight loss was not a parameter of nutrition.

Tr. at 187-191. Dr. Ahmad’s testimony is not inconsistent with her letter dated March 23,
2004. P. Ex. 8, at 1.

Ms. Matthiesen testified that this resident was on a calorie-controlled diet due to her
diabetes and difficulty maintaining acceptable blood-sugar levels. Upon admission her
blood-sugar levels looked good. However, after her admission to the facility, her family
started bringing in packs of snack size candy bars and that is all she would eat. She had
weight gain and her blood-sugar levels were out-of-control. Around June 2003, the
resident’s physician put her on a tighter diabetic regimen. Family was still permitted to
bring in candy, but had to leave it with the nurse who controlled distribution. Ms.
25

Matthiesen opined that a 30 pound weight loss between May and August 2003 was due to
controlling her candy bar intake. Around July 2003, she was moved to the assisted dining
room for cuing and supervision because she would refuse to feed herself. Petitioner also
started providing a high calorie supplement to try to stabilize the resident’s weight. The
texture of her food was changed due to a jaw fracture. She was also provided a fortified
cereal. Tr. at 208-15.

Records reveal the following weight loss for Resident 5:

July 2003 23.4 lbs.
August 2003 17.0 lbs.
September 2003 16.2 lbs.
October 2003 15.4 lbs.
November 2003 13.8 lbs.
December 2003 11.8 lbs.
January 2004 08.8 lbs.

CMS Ex. 3, at 538. These recorded weights reflect a loss of 14.6 pounds in seven months
from July 2003 to January 2004. However, a registered dietician note signed by Margaret
Herman on August 6, 2003, acknowledges that Resident 5 had a 30-pound weight loss
from June to August 2003. P. Ex. 7, at 3.

Dr. Ahmad’s progress note dated June 11, 2003, reflects that Resident 5 was recovering
from a left hip fracture that had been surgically repaired, a GI bleed from a duodenal
ulcer that had been cauterized, and seizure activity attributed to her Alzheimer’s dementia
that was controlled with Dilantin. The doctor noted a decline in the resident’s activity
level, her ability to perform activities of daily living, and that she was not eating well.
She was also noted to have a history of recurrent falls. P. Ex. 7, at2. She was admitted
to Ottumwa Regional Health Center from July 25 through 29, 2003, for treatment of a
urinary tract infection with intravenous antibiotics. Her admission note indicated a
history of a mandibular fracture due to a fall. P. Ex. 8, at 14-17. A nutrition assessment
from Ottumwa Regional Health Center dated July 28, 2003, indicates that Resident 5’s
appetite was poor, she had inadequate caloric intake due to increased dementia as
evidenced by a loss of 23.6 pounds in one month. Laboratory values showed a low serum
albumin indicating a poor protein level. P. Ex. 7, at 6. Petitioner’s registered dietician’s
note dated August 6, 2003, shows that the resident was started on a medication for her
diabetes on May 30, 2003, that she had a poor appetite, and that she complained that

26

chewing hurt her mouth.° The dietician, Ms. Herman, recommended a change to a
liquified diet and increasing her liquid supplement to four times per day to help prevent
further weight loss. She noted the last laboratory report indicated low serum albumin,
which indicates a poor protein level. P. Ex. 7, at 3. A dietician note by Ms. Herman
dated September 9, 2003, shows the resident’s weight was 116.2 pounds but states she
was stable over the last month. The resident continued a blended diet with supplement
twice per day with a multivitamin. P. Ex. 7, at 4. There is no indication that Ms. Herman
reviewed her prior recommendation for a liquified diet or to increase the supplement, and
there is no indication she requested an assessment to determine the cause for the
resident’s complaint of pain when chewing. Resident 6 was admitted to Ottumwa
Regional Health Center on November 10, 2003, for administration of intravenous
antibiotics to treat a urinary tract infection, and she was discharged back to Petitioner on
November 16, 2003. P. Ex. 8, at 9. A history of mandibular fracture was noted on
admission. P. Ex. 8, at 10. A nutrition assessment on an Ottumwa Regional Health
Center form completed by Margaret Herman on November 11, 2003, records a weight of
122 pounds (clearly at odds with other clinical records of this resident), a low serum
albumin, and notes that Resident 5 has an inadequate feeding route due to a mandibular
fracture as evidenced by past weight loss. P. Ex. 7, at 8. A quarterly nutrition assessment
was completed by Ms. Matthiesen on November 26, 2003. Resident 5’s weight is listed
as 113 pounds. Ms. Matthiesen notes the resident refused to eat in July 2003 due to the
fact she could not chew, and she was changed to a blended texture diet. She notes that
weight loss is expected because of intake of only 35 percent. She indicated that weight
loss had stabilized, that the resident was under good diabetic control, and that the present
plan for nutrition would continue. P. Ex. 7, at 5. A nutrition data sheet dated November,
26, 2003, shows that Ms. Matthiesen directed the addition of fortified cereal to the
resident’s diet. P. Ex. 7, at 10. A note from Dr. Ahmad’s record’s dated January 21,
2004, indicated that Resident 6 was on a pureed diet due to her jaw fracture several
months ago. P. Ex. 8, at 5.

Only two pages from Resident 5’s MDS with an assessment reference date of November
24, 2003, were provided. The partial MDS shows that she had moderately impaired
decision-making skills, required supervision for eating, and had a chewing problem. The
assessment reflected the resident was 60 inches tall, weighed 113 pounds, and had a
significant weight loss. P. Ex. 7 at 12-13.

° The date on which Resident 5 suffered the jaw fractured is not indicated in the
records submitted for my review. I also find no assessment contemporaneous with the
dietician’s note that indicates whether or not the pain complained of was due to the jaw
fracture.
27

Petitioner argues that Resident 5 was on a planned weight change program and that the
resident was always in the range of her ideal body weights. P. Br. at 9, 20. Petitioner
also argues that the facility implemented interventions to address the resident’s weight
loss including, moving the resident to the assisted dining room for closer staff supervision
and cuing, use of liquid supplements, and change of texture. P. Br. at 20; P. Reply at 8.
Petitioner’s third-line of defense is that the resident’s physician testified that the
resident’s weight loss was clinically unavoidable due to her dementia and multiple co-
morbidities. P. Br. at 20; P. Reply at 8.

According to Ms. Matthiesen, upon admission to Petitioner’s facility, Resident 5’s blood
sugar levels were good. However, the resident’s family started bringing in bags of small
candy bars, and the resident would eat the entire bag. Ms. Matthiesen did not indicate in
her testimony that the resident was prevented by physical or other reasons from eating
whatever she liked, including bags of candy. Because her diet was not controlled and she
was able to eat an entire bag of candy bars, her blood sugar levels were uncontrolled.
According to Ms. Matthiesen, this provoked the weight control program to which Ms.
Matthiesen attributed the 30 pound weight-loss the resident experienced between May
and August 2003. Tr. at 208-09. This testimony is inconsistent with her November 26,
2003, nutrition note which indicated that in July 2003 the resident refused to eat because
she could not chew. P. Ex. 7, at 5. Further, the only specific element of the weight-
control plan that I have discerned from the evidence is that a nurse kept the candy bars
and limited their distribution to the resident, and this is based only upon Ms. Matthiesen’s
testimony. A loss of 30 pounds in four months precipitated by reducing the number of
candy bars eaten by the resident, suggests that she was eating a lot of candy bars before
the intervention.

Petitioner’s evidence does not clearly indicate whether or not the weight control program
Ms. Matthiesen testified to, continued after August 2003. Because Resident 5 was
diabetic and her blood sugar needed to be in a stable range, I will assume that candy bar
control continued as part of good medical management of her diabetes. However, the
evidence does not show that the resident’s continuing weight loss from 117 pounds in
August 2003 to 108.8 pounds in January 2004, is attributable in whole or part to any
planned weight control program. In fact, the summary of dietician and other clinical
notes I have set out clearly show that the dieticians, Ms. Herman and Ms. Matthiesen,
were not satisfied that the resident was experiencing a planned weight loss. Rather,
Petitioner admits interventions were undertaken in an effort to stabilize the resident’s
weight. In fact, as early as August 2003, Ms. Herman recommended changing food
texture and doubling the resident’s liquid supplement to stop weight loss.
28

Petitioner elicited Dr. Ahmad’s opinion that weight loss for this resident was unavoidable.
Dr. Ahmad qualified her opinion by stating that short of coaxing the resident, or insertion
of a feeding tube, or other extraordinary measures, weight loss was unavoidable. Dr.
Ahmad also implied that Petitioner had done all it could do to ensure the resident received
good nutrition. I have already noted that my inclination is to give heavy weight to a
treating sources’ opinion but only if that opinion has a sound basis. There is no evidence
that Dr. Ahmad spent any time observing the delivery of nutrition to Resident 5 by
Petitioner’s staff. The frequency of Dr. Ahmad’s visits to the facility so that she might
have occasion to observe and what she observed during visits is not established. The
evidence also does not show to what extent Dr. Ahmad participated in care planning for
the resident with Petitioner’s staff or that she otherwise communicated, except through
orders, with either nutritionist, Ms. Herman or Ms. Matthiesen. Thus, I cannot conclude
that Dr. Ahmad had an adequate basis for her opinion regarding the quality of the delivery
of nutrition to Resident 5. While I do not question Dr. Ahmad’s opinion that the
resident’s dementia and “co-morbidities” contributed to decreased appetite and weight
loss, I do not find credible her opinion that the weight loss was clinically unavoidable
given her lack of information about what efforts to nourish the resident were undertaken
'y Petitioner’s staff, including information that showed the quality and consistency of
those efforts.

find no fault with the nutritionist’s decision to use supplemental nutrition such as liquid
supplements and fortified cereal. However, the evidence shows that the nutritionists were
not diligent about ensuring such interventions were implemented. Ms. Herman
recommended in August 2003, that the resident be placed on a liquified diet and that her
iquid supplement be increased to four times per day to prevent further weight loss.

However, Ms. Herman’s September 2003 note shows that the resident continued on a
lended diet with liquid supplement only twice per day. There is evidence that Ms.
Matthiesen added fortified cereal on November 26, 2003, but the evidence does not show
that Ms. Herman’s recommendation to double the resident’s supplements was ever acted
upon.

find no fault with the decision to move the resident to the assisted dining room for cuing
and supervision around July 2003. However, Petitioner has not shown that this
intervention had any effect because there is no evidence that cuing, supervision, or
feeding were provided by staff to this or any resident. In fact, a note from Petitioner’s
record with the title “Nutrition Risk Committee Meeting” December 2, 2003, shows that
Ms. Matthiesen, Petitioner’s registered dietician, expressed concern that the speech
language pathologist had identified that Petitioner’s aides were not using proper
technique to feed residents. Ms. Matthiesen called for an assessment of what feeding
training was being provided, what training needed to be provided, and what was
29

necessary to hold aides accountable to use proper feeding techniques. CMS Ex. 2, at 37.
Thus, the fact that the resident was moved to the assisted dining room does not alone
establish that she was receiving cuing, supervision, or actual assistance with eating. Dr.
Ahmad opined that coaxing the resident might have been effective, but Petitioner has
presented no evidence that its aides used coaxing when assisting residents in the assisted
dining room. Simply placing nourishment before a resident is not sufficient to ensure a
resident receives adequate nutrition. Rather, Petitioner needs to establish that it took all
reasonable steps to ensure adequate nourishment was actually ingested. Any
interpretation of the regulatory requirement that imposes a lesser requirement upon a
long-term care facility, would render meaningless the requirement of the regulation.

The evidence shows that in June 2002, Dr. Ahmad considered placement of a feeding
tube to ensure the resident received the appropriate level of nutrition, but that intervention
was rejected by the resident’s family. There is no question that the decision to place a
feeding tube is made by a physician in consultation with the family. However, in this
case, the consultation and refusal by the family was nearly a year before evidence of
malnutrition, as evidenced by weight loss, developed. Although Petitioner could not have
had a feeding tube placed without consent of the family and direction of the doctor,
Petitioner should have ensured that the option was again discussed with the family when
evidence of malnutrition developed.

The examples of the five residents show that CMS established a prima facie case of
noncompliance with the requirements of 42 C.F.R. § 483.25(i)(1). The discussion for
each resident also demonstrates that Petitioner has failed to show by a preponderance of
the evidence that it was in substantial compliance or that it had an affirmative defense.
The examples show that in one or more cases, Petitioner failed to assess unplanned
weight-loss promptly, failed to care plan, failed to develop interventions, failed to
implement proposed interventions, failed to assess the effectiveness of interventions and
to modify interventions as necessary. Petitioner’s failures resulted in continuing weight
loss over periods of months, and I have no difficulty concluding that this amounted to
actual harm.

30

II. Conclusion

For the foregoing reasons, Petitioner violated 42 C.F.R. § 483.25(i)(1) in the case of five
residents as alleged by CMS. The state was required to withdraw approval of Petitioner’s
NATCEP for a period of two years from the date of the survey because the violations
amounted to substandard quality of care that required an extended or partial-extended
survey.

/s/
Keith W. Sickendick
Administrative Law Judge


Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

In the Case of: )
)
Grace Healthcare of Benton, ) Date: October 20, 2007

)
Petitioner, )
)

-V.- ) Docket No. C-06-610

) Decision No. CR1676
Centers for Medicare & Medicaid )
Services. )
_ )

DECISION

I sustain CMS’s determination to impose civil money penalties of $3,500 per day against
Petitioner, Grace Healthcare of Benton. I also find that Petitioner is disqualified from
participating in a Nurse Aide Competency and Evaluation Program (NATCEP).

I. Background

Petitioner is a skilled nursing facility doing business in the State of Arkansas. It
participates in the Medicare program. Its participation in Medicare is governed by
sections 1819 and 1866 of the Social Security Act and by implementing regulations at 42
C.F.R. Parts 483 and 488. Additionally, its right to a hearing and the administrative
proceedings in this case are governed by regulations at 42 C.F.R. Part 498.

On June 14, 2006 CMS advised Petitioner that it had determined to impose remedies
against it based on findings that Petitioner had failed to comply substantially with
Medicare participation requirements. CMS based its determinations on the findings made
at a compliance survey of Petitioner’s facility completed on May 25, 2006 (May survey).
The remedies included civil money penalties of $3,500 per day for a period that included
May 17 and 18, 2006, and additional civil money penalties of $350 per day for
noncompliance after May 18. The May 17 and 18 civil money penalties were based on
CMS’s determination that, on those dates, Petitioner’s noncompliance with participation
2

requirements was so egregious as to comprise immediate jeopardy for Petitioner’s
residents.’ CMS also told Petitioner that, as a consequence of its noncompliance,
Petitioner would lose authority to conduct NATCEP.”

Petitioner requested a hearing and the case was assigned to me for hearing and decision. I
issued a pre-hearing order which instructed the parties to file written pre-hearing
exchanges consisting of their proposed exhibits, including the written direct testimony of
each proposed witness, and briefs addressing all of the issues in the case. After receiving
the parties’ exchanges I scheduled an in-person hearing. Then, I conducted a pre-hearing
conference with the parties. The upshot of that conference was that the parties agreed to
waive an in-person hearing and to have the case heard and decided based on their
exchanges. I set a deadline for the parties to submit final briefs.

The parties complied with that deadline. On September 27, 2007 I conducted a second
pre-hearing conference with the parties because it seemed that Petitioner, in its final brief,
appeared to be expressing second thoughts about its decision to waive an in-person
hearing. I offered to schedule an in-person hearing if the parties wanted one. Petitioner
then assured me that it did not want an in-person hearing.

At the September 27 pre-hearing conference I also ruled on a motion filed by CMS
objecting to the admission into evidence of two written statements submitted by
Petitioner. I overruled these objections.

CMS submitted 37 proposed exhibits with its pre-hearing exchange which it identified as
CMS Ex. 1 - CMS Ex. 37. Petitioner submitted 38 proposed exhibits which it identified
as P. Ex. 1 - P. Ex. 38. I am receiving all of these proposed exhibits into evidence.

Petitioner resubmitted 17 of its proposed exhibits as an attachment to its final brief in this
case and it renumbered them. I do not receive any of these into evidence because they are
cumulative and it would confuse the record if I were to receive from a party more than
one version of the same exhibit, especially inasmuch as Petitioner gave the exhibits in its
second submission different identifying numbers than it gave corresponding exhibits in its
first submission. I note, however, that all of the 17 exhibits in Petitioner’s second

' The term “immediate jeopardy” is defined at 42 C.F.R. § 488.301 to mean
noncompliance by a facility that has caused, or is likely to cause, serious injury, harm,
impairment, or death to a resident.

> CMS mentioned other remedies in its June 14 notice letter but it did not impose
any of them.
3

submission are duplicates of other exhibits contained in its original submission of 38
proposed exhibits, and I have received Petitioner’s entire original submission into
evidence.

II. Issues, findings of fact and conclusions of law
A. Issues

Petitioner waived its right to challenge CMS’s determination to impose civil money
penalties of $350 per day for dates beginning with May 19, 2006. Consequently, these
remedies, and the deficiencies on which they are based, are not at issue.

What remains at issue is the $3,500 per day civil money penalties that CMS determined to
impose for May 17 and May 18, 2006.’ CMS premised its determination to impose these
penalties on the alleged presence of six immediate jeopardy level deficiencies. I find it
to be unnecessary that I address all of these alleged deficiencies in order to issue a
decision that sustains CMS’s remedy determination. As I discuss below, the $3,500 per
day civil money penalty that CMS determined to impose is amply justified by the
presence of a single immediate jeopardy level deficiency, the failure by Petitioner or its
staff to investigate the causes of numerous apparent bruises sustained by one of

* Counsel for CMS created considerable confusion as to the duration and basis of
these remedies. The June 14, 2006 notice letter from CMS to Petitioner recited a
determination by CMS to impose daily civil money penalties of $3,500 for the dates of
May 17 and 18, 2007. In her initial brief CMS counsel asserts that this was the remedy
that CMS had determined to impose. However, at times, and in particular, in its final
brief, CMS counsel talks about “a” $3,500 civil money penalty, suggesting that CMS is
seeking that amount to remedy only a single day of noncompliance. I may have been
misled by counsel to the extent that, in my July 18, 2007 Order Scheduling Final Briefs, I
may have incorrectly assumed, based on counsel’s statements, that it intended to impose
only “a” civil money penalty of $3,500. CMS’s counsel added to the confusion in its
final brief by referring to the $3,500 civil money penalty as a per instance civil money
penalty. I do not resolve this confusion here. Rather, I rely on CMS’s notice letter to find
that Petitioner’s noncompliance at the immediate jeopardy level was for a two day period
consisting of May 17-18, 2006 and I sustain the imposition of daily civil money penalties
for both of those days. If CMS has, in fact, determined to modify its remedy to a one-day
civil money penalty or even to a per-instance penalty then, of course, it may impose such
a remedy on the strength of my decision. If, on the other hand, Petitioner believes that
CMS has waived imposing a remedy for one of the two days, it may move to clarify my
decision. In that event I will, of course, accept argument from CMS as well.

4

Petitioner’s residents. For that reason, I decline to decide whether Petitioner was
deficient in other respects.

The issues that I decide, therefore, are whether:

1. Petitioner failed to comply substantially with a Medicare participation
requirement;

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

3. Daily civil money penalties of $3,500 are reasonable; and
4. Petitioner must lose its authority to conduct NATCEP.
B. Findings of fact and conclusions of law

I make findings of fact and conclusions of law (Findings) to support my decision in this
case. I set forth each Finding below as a separate heading. I discuss each Finding in
detail.

1. Petitioner failed to comply substantially with the requirements of 42
C.F.R. § 483.13(c)(2) - (4).

In pertinent part the regulation that is at issue here requires a participating facility’s staff
to:

+ Immediately report to the facility’s administrator all alleged violations involving
mistreatment, neglect or abuse of a resident, including injuries of unknown origin;

* Thoroughly investigate all such allegations;

+ Report all investigation results to the administration or his designated
representative and to appropriate official in accordance with State law within five
working days of the incident and to take appropriate corrective action as may be
required.

The facts concerning the care that Petitioner and its staff gave to Resident #1 are not
disputed. The resident was an elderly individual with numerous medical problems,
including congestive heart failure, chronic obstructive pulmonary disease, hypertension,
coronary artery disease, and Alzheimer’s disease. CMS Ex. 6, at 1,55. Her medications
5

included anti-coagulant drugs (Plavix and aspirin) and a diuretic (Lasix). Jd., at 208. The
resident clearly was an extremely frail and dependent individual. She had been assessed
by Petitioner’s staff to have moderately impaired cognitive skills and to require assistance
in daily activites including eating and use of the toilet. Jd., at 66 - 75.

The resident’s treatment record establishes that her physical condition deteriorated over a
period beginning on May 4, 2006. On that date she was discovered by Petitioner’s staff
to have a fecal impaction which necessitated manual removal. Bruises were noted on her
arms on that date. CMS Ex. 4, at 3-5; CMS Ex. 32, at 2-4. On May S, the staff noted an
egg-size bruise on the resident’s right hip. Jd. On May 6, the staff observed blood on the
resident’s cheek and multiple bruises on her coccyx, the right side of her chest, her legs,
and on the left side of her upper arm. CMS Ex. 4, at 5-6; CMS Ex. 32, at 2-4. On May 7,
the staff identified blood in the resident’s mouth and bruises on her arms. CMS Ex. 21, at
7. One of the certified nursing assistants who provided care to the resident stated that, as
of May 7 the resident had:

bruises on her legs and bottom. The biggest were about the size of eggs.
She had different colored bruises on her legs. The darkest was really dark
purple on the inside part of her left leg. She had a bruise on the coccyx, one
bruise on the right side of her chest, one on the left side of her upper arm.
The arm kind of looked like the skin had been roughed. I showed... [a
licensed practical nurse] the bruise on her left arm, it looked fresh. It was
bright purple and had some redness around it. I found the other bruises
when we rolled . . . [the resident] and uncovered her . .. There were more
bruises than I’ve ever seen on a person and I had not been told she had a fall
or anything.

CMS Ex. 4, at 18.

Resident #1 was sent to the hospital on May 7, 2006 as a consequence of her deteriorated
condition. The emergency room physician noted that the resident manifested multiple
bruises in a purplish state, as well as dried blood in the resident’s mouth. CMS Ex. 4, at
27. A physician at the hospital commented to members of Petitioner’s staff about the
state of the resident noting that the resident had not been bruised prior to her admission to
Petitioner’s facility. CMS Ex. 4, at 15-16.

CMS contends that there is nothing documented in Resident #1’s treatment record
showing that Petitioner or its staff investigated the cause of the resident’s apparent
bruises. There are no incident reports, no investigative summaries, no statements taken
from staff, and no documentation of injuries of an unknown source and a followup
investigation being reported to Petitioner’s administrator. Nor, according to CMS, did
6

Petitioner’s staff conduct a comprehensive assessment of the resident during the May 4-7,
2006 period in order to determine whether the resident’s medical condition was the cause
of her injuries or whether some other cause, including abuse, might explain the injuries.

The evidence offered by CMS strongly supports a finding that Petitioner failed to
discharge its regulatory responsibility to investigate the injuries manifested by

Resident #1 as possible signs of abuse, neglect, or mistreatment. A facility has an
absolute duty to treat every resident injury from an unknown source as evidence of
possible abuse, neglect, or mistreatment, until it establishes the injury’s cause. Here, the
evidence offered by CMS shows that Resident #1 manifested obvious — and extreme —
external injuries over a three day period that Petitioner’s staff did not investigate.

Petitioner’s defenses to CMS’s prima facie case are that:

+ Resident #1 did not suffer from bruising but, rather, “a lot of ecchymosis”,
probably as a consequence of the anti-coagulant medication that she was taking.
P. Ex. 17, at 1 (cited in Petitioner’s final brief as “P. Ex. 1.”).

+ Petitioner and its staff did not view the resident’s ecchymosis as an injury of
unknown origin or as an allegation of potential abuse, because the resident was
receiving anticoagulant medication. Petitioner’s staff conferred with the resident’s
attending physician regarding its determination that the resident’s ecchymosis was
medically related. Petitioner’s final brief at 28.

+ Resident #1 was in very poor health during the period from May 4-7, 2006 and
was terminally ill. Her treatment by Petitioner was appropriate and there is no
evidence that the resident was in any way abused or neglected. P. Ex. 17 (cited in
Petitioner’s final brief as “P. Ex. 1”); P. Ex. 24 (cited in Petitioner’s final brief as
“P. Ex. 2”).

I do not find these defenses to be persuasive. Nothing offered by Petitioner overcomes
the prima facie case of noncompliance established by CMS.

Petitioner identified no evidence to show that its staff assessed the nature of the resident’s
injuries during the May 4-7 period. It is clear from the evidence offered by CMS, which
includes statements taken from several of Petitioner’s certified nursing assistants, that the
staff observed what they thought to be bruises on the resident’s body during that period.
The staff did not investigate the sources of these injuries during the period. Petitioner has
offered no records that document such an assessment having been made.
7

I have no reason to dispute the conclusion of Petitioner’s experts — made from the vantage
point of hindsight — that the resident’s injuries were ecchymosis caused by a reaction to
medication and not bruises caused by trauma. Nor do I find to be unpersuasive
Petitioner’s contention that the resident suffered from terminal illness. But, there is
nothing of record to show that these assessments was made, or even sought by
Petitioner’s staff, while the resident was manifesting her injuries. Petitioner has cited
absolutely nothing to support its contention that the staff determined while the resident
was at the facility that the resident’s injuries were, in fact, ecchymosis.

Petitioner included as an exhibit a very lengthy portion of Resident #1's treatment record
at Petitioner’s facility. P. Ex. 5, at 1-358. Petitioner did not identify any document in that
record which consisted of an assessment made during the May 4-7 period ruling out
trauma as a cause of the resident’s injuries. Nurses notes made during that period do not
identify or describe the full extent of the resident’s injuries much less do they assess their
cause. Id., at 209-213.

The burden falls squarely on Petitioner to identify an assessment of the resident’s injuries
made during the May 4-7 period if, in fact, it existed. I infer from Petitioner’s failure to
do so that no assessment was made. The precise cause of the injuries sustained by
Resident #1 during the May 4-7, 2006 period was, in fact, not established by Petitioner’s
staff prior to the resident being sent to the hospital on May 7.

Nor is there any evidence to support a finding that Petitioner’s staff consulted with the
resident’s attending physician prior to the resident being sent to the hospital and that,
prior to the hospitalization, the physician ruled out bruising caused by trauma as a cause
of the resident’s injuries. The resident’s records are devoid of evidence that a
consultation took place. The two statements that Petitioner offered from the physician do
not support a finding that a consultation occurred. P. Ex. 24; P. Ex. 25. The physician
avers that:

Prior to this [May 7, 2006 hospital] admission, the Resident developed ecchymosis
which was caused by the administration of Plavix and aspirin . .. The ecchymosis
was not caused by injury or accident.

P. Ex. 24, at 3. But, he does not aver that he made this assessment prior to the May 7
hospital admission.
8

2. Petitioner did not prove to be clearly erroneous CMS’s determination
that Petitioner’s noncompliance put residents at immediate jeopardy.

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

Moreover, there is an obvious likelihood of serious injury, harm, or death to facility
residents resulting from a failure by a facility to investigate injuries of unknown origin
such as those displayed by Resident #1. Because Petitioner failed to investigate and
assess the nature of the resident’s injuries it had no way of knowing whether the injuries
were caused by a medical condition or by trauma. The resident was extraordinarily
vulnerable to possible abuse given her frailty and dependence on Petitioner’ staff. Under
those circumstances any physical abuse might have been lethal and yet, the facility did
nothing to rule out the possibility of abuse.

3. Civil money penalties of $3,500 per day are reasonable.

Regulations establish that daily civil money penalties to remedy an immediate jeopardy
level deficiency or deficiencies must fall into a range of from $3,050 to $10,000 per day.
42 C.F.R. § 488.438(a)(1)(i). What is a reasonable penalty amount within that range
depends on regulatory factors governing penalty amounts set forth at 42 C.F.R.

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

§ 488.438(f)(3)). These factors include: the seriousness of a deficiency or deficiency; the
relationship between deficiencies; a facility’s financial condition; and, a facility’s
culpability for its noncompliance.

The civil money penalty amount determined by CMS in this case — $3,500 per day — is
close to the bottom of the permissible range for immediate jeopardy level penalty
amounts. I decide that it is reasonable because it takes into account the seriousness of
Petitioner’s noncompliance. The risk that a resident suffering from injuries of an
unknown source may be a victim of abuse, neglect, or mistreatment, is evident. Residents
of nursing facilities include some of the frailest, most vulnerable members of our society.
Such individuals are totally dependent on a facility’s staff to protect them from possible
maltreatment. Here, Petitioner failed to discharge its basic and fundamental obligation to
Resident #1 to investigate the source of her then-unknown injuries. That failure
9

potentially put Resident #1 at risk of great harm. But, it also demonstrated a failure on
the part of Petitioner’s staff to recognize their duty to serve as residents’ guardians and
protectors. That failure put all of Petitioner’s residents at risk.*

As I discuss above, CMS alleged five additional immediate jeopardy level deficiencies at
Petitioner’s facility which I do not address in this decision. While the presence of one or
more additional deficiencies at the immediate jeopardy level certainly would be an added
basis of support for the penalty amount the presence of any of them is not necessary to
establish a basis here for the penalty amount that I sustain. The seriousness of
Petitioner’s failure to investigate the cause of Resident #1’s injuries is, in and of itself,
sufficient to justify the low-end penalties of $3,500 per day.

4. Petitioner loses the authority to conduct NATCEP because it
manifested an immediate jeopardy level deficiency.

The presence of immediate jeopardy noncompliance by a facility with the requirements of
42 C.F.R. § 488.413 is defined by regulation to constitute a substandard quality of care
mandating that CMS or its representative conduct a partial extended survey of that facility
in order to assure compliance with Medicare participation requirements. 42 C.F.R.

§§ 488.301; 488.310. A facility’s authority to conduct NATCEP must be revoked where
a facility is subject to a partial extended survey. 42 C.F.R. § 483.151(b)(2)(iii). Thus,
Petitioner’s immediate jeopardy level noncompliance with the requirements of 42 C.F.R.
§ 483.13 is a basis for a finding of substandard quality of care, a mandated partial
extended survey, and loss of authority to conduct NATCEP.

/s/
Steven T. Kessel
Administrative Law Judge

* Petitioner offered no evidence to show that its financial condition precludes it
from paying the civil money penalties that CMS determined to impose.