Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

In the Case of: )
)
Lake City Extended Care Center, ) Date: September 23, 1997

)
Petitioner, )
)

-Vv.- ) Docket No. C-96-206

) Decision No. CR494
Health Care Financing )
Administration. )
)

DECISION

I decide that the Health Care Financing Administration (HCFA) is not authorized
to impose a civil money penalty of $7,500 per day against Petitioner, Lake City
Extended Care Center, for the period from November 21, 1995 until December
19, 1995. I decide also that I have no authority to order that a civil money
penalty be imposed against Petitioner of less than the $7,500 per day that HCFA
determined to impose.

I. Procedural history, governing law, and background facts

The procedural history, governing law, and background facts which I recite in
this portion of my decision are not disputed by the parties.

A. Procedural history

Petitioner is a 60-bed skilled nursing facility located in Lake City, Florida.
Petitioner participates in the Medicare program.
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Petitioner’s hearing request in this case is from a notice which HCFA sent to
Petitioner on February 22, 1996. HCFA Ex. 11. In that notice, HCFA advised
Petitioner that the State of Florida Agency for Health Care Administration
(Florida State survey agency) had conducted a survey of Petitioner which ended
on November 21, 1995. HCFA told Petitioner that the Florida State survey
agency had ascertained that Petitioner was not in substantial compliance with
federal Medicare and Medicaid participation requirements. HCFA asserted
additionally that the Florida State survey agency had concluded that the level of
Petitioner’s noncompliance was so serious as to constitute immediate jeopardy to
the health or safety of the residents of Petitioner.

HCFA informed Petitioner that, based on the findings of the Florida State survey
agency, HCFA had determined to impose against Petitioner a civil money penalty
of $7,500 per day. The penalty was to begin to accrue on November 21, 1995,
and continue until December 19, 1995, the date that HCFA determined that
Petitioner had attained substantial compliance with participation requirements.
HCFA stated that, in making its determination to impose a penalty of $7,500 per
day it had considered factors which included: the scope and severity of the
asserted deficiencies; Petitioner’s history of noncompliance with program
participation requirements; its financial condition; and Petitioner’s culpability for
the asserted deficiencies.

Petitioner requested a hearing from HCFA’s determination. The case was
assigned to me for a hearing and a decision. On March 25 and 26, 1997, I held
an in-person hearing in Atlanta, Georgia. At the hearing, I received the
testimony of witnesses for HCFA and Petitioner. Both HCFA and Petitioner
offered written exhibits in addition to the testimony of their witnesses. I received
into evidence HCFA Ex. | - 18 and P. Ex. 1 - 15. At the close of the in-person
hearing I established a schedule for the parties to submit posthearing briefs and
reply briefs. The parties have complied with this briefing schedule.

Petitioner submitted an additional exhibit, P. Ex. 16, with its posthearing brief.
Petitioner submitted yet an additional exhibit, which it designated as “Exhibit B”,
with its posthearing reply brief (Petitioner also submitted an “Exhibit A” with its
reply brief which constitutes an appendix to the reply brief. Petitioner is not
offering “Exhibit A” as evidence). For purposes of maintaining a consistent
record I have redesignated Petitioner’s Exhibit B as P. Ex. 17.
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HCFA objects to my receiving into evidence P. Ex. 16 and P. Ex. 17. HCFA
filed a motion with its reply brief in which it requested that I exclude P. Ex. 16
from evidence. The Respondent’s Motion to Strike the Petitioner’s Proposed
Exhibit. HCFA asserts that Petitioner submitted P. Ex. 16 untimely and that the
exhibit is of questionable probative value. Id, HCFA did not file a motion to
exclude P. Ex. 17 from evidence. However, in its reply brief, HCFA asserted
that Petitioner offered P. Ex. 17 untimely and that the exhibit is of questionable
probative value.

I am receiving P. Ex. 16 into evidence. The exhibit is an excerpt from a
medical treatise and is offered by Petitioner to rebut an assertion of fact that one
of HCFA’s witnesses, Charles Fuller, R.N., testified to at the March 25 - 26,
1997 hearing, concerning the span of body temperatures that an individual might
exhibit depending on the method used to take that individual’s temperature. This
assertion was not communicated by HCFA to Petitioner in any of the notices that
HCFA or the Florida State survey agency gave to Petitioner or in any of the
exhibits that were exchanged prior to the hearing.

There is nothing in the record to suggest that Petitioner knew of the assertion
prior to the hearing. Receipt of P. Ex. 16 is consistent with the instructions I
gave to the parties concerning the impact that the appellate panel’s decision in
Hillman Rehabilitation Center at DAB 1611 (1997) might have on my conduct of
this case. Tr. at 6-10. I discuss the implications of the Hillman decision
below, at Part B. of this section. I discuss Mr. Fuller’s assertion, and
Petitioner’s rebuttal evidence below, at Finding 3.

I have decided not to admit P. Ex. 17 into evidence. In contrast to their purpose
for offering P. Ex. 16, Petitioner offers P. Ex. 17 to rebut arguments that HCFA
made in its posthearing brief. I find that these arguments are addressed
adequately by the record that was created at the hearing, along with P. Ex. 16.

B. Governing law

Under both the Social Security Act (Act) and applicable regulations, Petitioner is
classified as a long-term care facility. In order to participate in Medicare, a
long-term care facility must comply with federal participation requirements. The
statutory requirements for participation by a long-term care facility are contained
in the Act, at sections 1819 and 1919. Regulations which govern the
participation of a long-term care facility are published at 42 C.F.R. Part 483. A
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principal aspect of this case is Petitioner’s alleged noncompliance with the
requirements of one of the regulations in Part 483, 42 C.F.R. § 483.25.

Sections 1819 and 1919 of the Act give the Secretary of the United States
Department of Health and Human Services (Secretary) authority to impose
against a long-term care facility a civil money penalty for failure by the facility
to comply substantially with participation requirements. The Secretary has
delegated to HCFA and the States the authority to impose remedies against a
long-term care facility that is not complying substantially with federal
participation requirements. 42 C.F.R. Part 488.

The Part 488 regulations provide that facilities which participate in Medicare may
be surveyed on behalf of HCFA by State survey agencies in order to ascertain
whether the facilities are complying with participation requirements. 42 C.F.R.
§§ 488.10 - 488.28. The regulations contain special survey provisions for long-
term care facilities. 42 C.F.R. §§ 488.300 - 488.325. Under the Part 488
regulations, a State or HCFA may impose a civil money penalty against a long-
term care facility where a State survey agency ascertains that the facility is not
complying substantially with participation requirements. 42 C.F.R. §§ 488.406,
488.408, 488.430. The penalty may be imposed for each day that the facility is
out of compliance. Id.

The regulations specify that a civil money penalty that is imposed against a
facility will fall into one of two broad ranges of penalties. 42 C.F.R. §§
488.408, 488.438. The upper range of civil money penalties, of from $3,050
per day to $10,000 per day, is reserved for deficiencies that constitute immediate
jeopardy to a facility’s residents, and, in some circumstances, for repeated
deficiencies. 42 C.F.R. §§ 488.438(a)(1), (d)(2). The lower range of civil
money penalties, of from $50 per day to $3,000 per day, is reserved for
deficiencies that do not constitute immediate jeopardy, but either cause actual
harm to residents, or cause no actual harm, but have the potential for causing
more than minimal harm to residents. 42 C.F.R. § 488.438(a)(2).

The terms “substantial compliance” and “immediate jeopardy” are defined terms
in the regulations which govern participation of long-term care facilities in
Medicare. “Substantial compliance” is defined to mean:

a level of compliance with the requirements of participation such
that any identified deficiencies pose no greater risk to resident
health or safety than the potential for causing minimal harm.
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42 C.F.R. § 488.301. “Immediate jeopardy” is defined to mean:

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

Id.

There are additional factors which the State and HCFA consider in determining
where within a range of penalties, a penalty should be determined once the range
is established. These include the facility’s: (1) history of noncompliance,
including repeated deficiencies; (2) financial condition; and, (3) culpability for
the deficiencies. 42 C.F.R. § 488.438(f). Additionally, the State and HCFA
may consider factors specified in 42 C.F.R. § 488.404. These include the
relationship that a deficiency may have to other deficiencies, and a facility’s prior
history of deficiencies.

A civil money penalty which falls within the lower range of penalties may not be
increased to the upper range based on the presence or absence of factors
described in 42 C.F.R. §§ 488.404 and 488.438(f), unless the deficiency at issue
is a repeated deficiency. And, a civil money penalty which falls within the upper
range of penalties may not be decreased to the lower range based on the presence
or absence of factors described in 42 C.F.R. §§ 488.404 and 488.438(f).

A long-term care facility against whom HCFA has determined to impose a civil
money penalty is entitled to a hearing before an administrative law judge at
which the facility may contest HCFA’s determination. 42 C.F.R. §§ 488.408(g);
498.3(b)(12),(13): see 42 C.F.R. § 488.438(e). The right to a hearing, and the
authority of an administrative law judge to conduct a hearing, is only from a
determination by HCFA to impose a remedy. 42 C.F.R. §§ 488.408(g),
498.3(b). Where HCFA has not determined to impose a remedy against a
facility, that facility has no right to a hearing, and the administrative law judge is
not authorized to conduct a hearing. Rafael Convalescent Hospital, DAB CR444
(1996), aff'd at DAB 1616 (1997).

There are potentially two issues to be heard and decided in a case where a long-
term care facility requests a hearing before an administrative law judge from a
determination by HCFA to impose a civil money penalty against the facility.

The first issue is whether the facility was not complying substantially with federal
participation requirements on the date or dates for which HCFA determined to
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impose a civil money penalty. The second issue is, assuming that noncompliance
is established, whether the amount of the penalty imposed by HCFA is
reasonable. 42 C.F.R. §§ 488.408(g); 498.3(b)(12), (13); see 42 C.F.R. §
488.438(e). The issue of reasonableness of the penalty is not reached unless
there is a finding of substantial noncompliance on which a penalty may be
predicated. Id.

In Hillman, an appellate panel of the Departmental Appeals Board held that, in a
case involving a determination by HCFA based on the results of a survey of a
provider, HCFA bears the burden of coming forward with evidence sufficient to
establish a prima facie case that the provider is not complying with an applicable
participation requirement or requirements. Once a prima facie case is
established, the provider bears the burden of proving, by a preponderance of the
evidence, that it was complying substantially with the participation requirement
or requirements. Id.

This case was assigned to me before the appellate panel issued its decision in
Hillman. Originally, I assigned to HCFA the burden of proving by a
preponderance of the evidence that Petitioner was not complying substantially
with the participation requirement which was the basis for HCFA’s determination
to impose a civil money penalty against Petitioner. At the beginning of the
hearing of this case, I discussed with the parties the potential implications of
Hillman. Tr. at 6 - 10. I advised Petitioner that I would consider permitting it
to supplement its evidence, in light of the appellate panel’s decision to impose on
a facility the burden of proving by the preponderance in evidence that it complied
with relevant participation requirements. Id.

A long-term care facility potentially bears an additional burden of proof in a case
involving a determination by HCFA to impose a civil money penalty against the
facility. The facility must prove that HCFA’s determination of the level of
noncompliance is clearly erroneous if the record of the case establishes that the
facility is not complying substantially with a participation requirement that is the
basis for HCFA’s civil money penalty determination. 42 C.F.R. § 498.60(c)(2)
(this regulation was formerly published as 42 C.F.R. § 498.61(b)). The facility
would not have to meet this additional burden in a case where it was able to
prove by a preponderance of the evidence that it was complying substantially
with the participation requirement or requirements on which HCFA premised its
civil money penalty determination.
C. Background facts
1. The September and November 1995 surveys of Petitioner

The Florida State survey agency surveyed Petitioner in September 1995. The
surveyors found Petitioner to be deficient in complying with various participation
requirements. HCFA Ex. 1. Petitioner does not contest the findings that were
made by the Florida State survey agency in September 1995. Petitioner does not
contest any determination to impose a remedy against it that may have been
based solely on those findings or on events that predated the September 1995
survey. Tr. at 20 - 21.

Surveyors employed by the Florida State survey agency returned to Petitioner’s
facility in November 1995. It is the results of the November 1995 survey that
are at issue in this case. HCFA Ex. 5. The November 1995 survey began on
November 20, 1995 and was completed on November 21, 1995. Tr. at 52;
HCFA Ex. 5. It consisted of an on-site visit to Petitioner’s facility, and included
a review of Petitioner’s resident records and interviews with members of
Petitioner’s staff. Tr. at 52 - 53.

The report of the November 1995 survey identified four deficiencies in
Petitioner’s operation. These deficiencies are listed in the survey report under
headings that are designated as “tags.” HCFA Ex. 5, at 2, 5, 7, 12; Tr. at 53.
Each of the tags states a requirement of participation that is contained in a
regulation. Id, Under each tag are the facts, and an explanation of the facts, on
which the surveyors based their finding of a deficiency.

The deficiencies that were identified by the surveyors at the November, 1995
survey are as follows (the facts and explanations that are cited in the survey
report are omitted from this list of deficiencies):

Tag 272 — failure to comply substantially with the requirements of
42 C.F.R. § 483.20(b). HCFA Ex. 5, at 2 - 5;

Tag 279 — failure to comply substantially with the requirements of
42 C.F.R. § 483.20(d). HCFA Ex. 5, at 5 - 7;

Tag 309 — failure to comply substantially with the requirements of
42 C.F.R. § 483.25. HCFA Ex. 5, at 7 - 11; and
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Tag 385 failure to comply substantially with the requirements of 42
C.F.R § 483.40(a)(1) and (a)(2). HCFA Ex. 5, at 12 - 13.

In the left hand margin of the November 1995 survey report, under each one of
the tags, is a scope and severity assessment of the deficiency described in the tag.
The scope and severity assessment is the surveyors’ findings of the scope and
severity of each deficiency, and is intended to describe the seriousness of that
deficiency. See Tr. at 50. “Scope and severity” is noted with the acronym
“SS.” After that acronym is a letter designating the scope and severity of the
deficiency. For example, under the tag heading 272, at page 2 of HCFA Ex. 5,
is the scope and severity notation “SS=F.”

The letter designations of scope and severity in the survey report may be
interpreted by referring to a guidance which HCFA issues to State survey
agencies, known as the State Operations Manual (SOM). The SOM contains a
chart which describes the letter characterizations of scope and severity. HCFA
Ex. 15. That chart is significant also because it prescribes the category of
remedies which may be imposed under each scope and severity designation. Id.

Although the scope and severity descriptions in HCFA Ex. 15 state the type of
remedies which may be imposed for deficiencies of a given scope or severity,
they do not direct that a particular remedy be imposed in a case. The State and
HCFA have discretion to determine whether a civil money penalty, or other
remedies described under a particular category, are imposed. 42 C.F.R. §
488.408. Therefore, if the scope and severity description of a deficiency directs
that a category 2 remedy be employed, that remedy may, but not must, include a
civil money penalty in the $50 - $3000 per day range. The remedy may not
include a civil money penalty in the $3,050 - $10,000 per day range.

The surveyors concluded that Tags 272 and 279 merited a scope and severity
designation of “F”. HCFA Ex. 5, at 2,5. A scope and severity designation of
“F” is described as comprising no actual harm to a resident with potential for
more than minimal harm that is not immediate jeopardy. A scope and severity
designation of “F” requires the imposition of category 2 remedies. Category 2
remedies may include: denial of payment for new admissions; denial of payment
for individuals (to be imposed by HCFA); and a civil money penalty in the $50 -
$3,000 per day range. HCFA Ex. 15. These remedies correspond with the
category 2 remedies described at 42 C.F.R. § 488.408(d).
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The surveyors concluded that Tag 385 merited a scope and severity designation
of “I”. HCFA Ex. 5, at 12 - 13. A scope and severity designation of “I” is
described as comprising actual harm to a resident that is not immediate jeopardy.
HCFA Ex. 15. This designation also requires the imposition of category 2
remedies. HCFA Ex. 15; 42 C.F.R. § 488.408.

Finally, the surveyors concluded that Tag 309 merited a scope and severity
designation of “L”. HCFA Ex. 5, at 7. A scope and severity designation of “L”
is described as comprising immediate jeopardy to resident health and safety.
HCFA Ex. 15. A scope and severity designation of “L” requires the imposition
of category 3 remedies. HCFA Ex. 15; 42 C.F.R. § 488.408. These may
include a civil money penalty in the $3,050 - $10,000 per day range.

There was initial uncertainty among the surveyors whether the deficiencies cited
at Tag 309 merited a scope and severity of “L” and an immediate jeopardy
designation. This survey was the first time that the surveyors encountered the
possibility that an immediate jeopardy finding might be imposed. Tr. at 55. The
concept of immediate jeopardy was something that was new to the surveyors. Id.
The surveyors were unable to reach a conclusion while they were at Petitioner’s
facility whether the deficiency listed under Tag 309 comprised immediate
jeopardy. Id. On the last day of the survey, the surveyors returned to their
office and discussed their findings with their office supervisors, who in turn
discussed the findings with the Florida State survey agency central office staff.
Id, It was after these discussions that the immediate jeopardy designation was
made. Id.

HCFA now asserts that the surveyors’ finding of Level “I” scope and severity
for the deficiency which they cited under Tag 385 was erroneous. HCFA’s
posthearing brief at 37. HCFA argues that this asserted deficiency should have
been given an immediate jeopardy designation. Id. HCFA asserts that an
immediate jeopardy designation for Tag 385 is reasonable inasmuch as the
deficiency under that tag is predicated on many of the same facts as are the basis
for the findings under Tag 309. Id. HCFA asserts, however, that it is not
arguing now that the scope and severity finding under Tag 385 should be
amended to include a finding of immediate jeopardy. Id, Thus, the immediate
jeopardy finding which is at issue in this case consists only of the finding made
under Tag 309, and not of any finding which the Florida State survey agency or
HCFA might have made, but did not make, under Tag 385.
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2. The findings which the surveyors made under Tag 309 at the
November 1995 survey

As I explain below, at Finding 10, the only findings that the Florida State survey
agency and HCFA made from the November 1995 survey which I conclude
ultimately to be at issue in this case are the findings made under Tag 309, which
are findings of a deficiency posing immediate jeopardy to Petitioner’s residents.
The findings under Tag 309 involve the asserted failure of Petitioner to comply
with the requirements of 42 C.F.R. § 483.25. The regulation requires a long-
term care facility to provide to each of its residents the care and services that are
necessary for the resident to attain or maintain the highest practicable level
physical, mental, or psychosocial well-being.

The surveyors found that Petitioner did not consistently monitor residents to
identify changes in the residents’ conditions which potentially could lead to harm
or deterioration in their status. HCFA Ex. 5, at 8. Moreover, according to the
surveyors, Petitioner did not react appropriately to the residents’ conditions or
changes in the residents’ conditions which could have led to harm to the residents
or to deterioration in their conditions. Id,

The surveyors made their findings principally from their review of resident
treatment records. They reviewed ten resident records and found evidence to
support their conclusions in the records of Resident 5 (P. Ex. 7; P. Ex. 8) and in
the records of Resident 1 (P. Ex. 9; P. Ex. 12). The gravamen of the surveyors’
findings concerning the care Petitioner provided to Resident 5 and to Resident |
is that Petitioner failed to monitor fevers that these residents manifested, and
failed to report the residents’ fevers to the residents’ treating physician on
occasions when the residents’ fevers exceeded 101 degrees. HCFA Ex. 5, at 7 -
11.

The surveyors found additional support for their conclusion that Petitioner had
failed to report residents’ fevers to the residents’ treating physician in a
conversation that the surveyors had with Petitioner’s Director of Nursing and a
unit charge nurse employed by Petitioner. HCFA Ex. 5, at 11. According to
the surveyors, they were told by the Director of Nursing that a resident’s
physician would always be called when a resident’s temperature exceeded 101
degrees. Id. The surveyors reported that the explanation for not calling the
physician in the case of Resident 5, when that resident’s fever exceeded 101
degrees, was that the resident had a viral condition and always ran a fever. Id.
The surveyors stated that Petitioner was unable to explain why the physician who
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treated Resident |-was not notified when the resident ran a fever in excess of 101
degrees. Id.

The initial review of records for the part of the November 1995 survey that
involved Tag 309 comprised a review of ten resident records. HCFA Ex. 5, at
8. After the surveyors concluded that Petitioner had failed to monitor or report
the temperatures of Residents | and 5, the surveyors expanded their survey to
review the vital signs sheets that were maintained at the nursing station in
Petitioner’s facility. Tr. at 158 - 159. They did not find evidence in these
documents of failure to monitor or report temperatures. The surveyors did not
examine the treatment records of any residents other than the ten which they
reviewed initially. Id.

All of the incidents which were the basis for the surveyors’ findings under Tag
309 were reported by the surveyors as occurring between September 12, 1995
and November 14, 1995. HCFA Ex. 5, at 8-11. The surveyors did not
document any failure by Petitioner to monitor a resident’s temperature or to
report a resident’s fever that occurred after November 14, 1995.

3. Events which occurred after the November 1995 survey

On November 25, 1995, a surveyor returned to Petitioner’s facility in order to
ascertain whether any residents manifested elevated temperatures, and whether
the facility was notifying the residents’ treating physicians of residents’ elevated
temperatures. Tr. at 155 - 156. The surveyor found no evidence that a resident
had an elevated temperature. Id.

On November 30, 1995, the Florida State survey agency sent a notice to
Petitioner. HCFA Ex. 7. The notice first recited the results of the September
1995 survey of Petitioner. Petitioner was advised that one of the findings made
as a consequence of the November 20 - 21 survey was that Petitioner had not
attained substantial compliance with participation requirements. Petitioner was
advised, therefore, that a civil money penalty of up to $3,000 per day would be
imposed on Petitioner retroactive to September 14, 1995. Id. at 1. As I note
above, Petitioner is not contesting any remedy that might be imposed against it
based solely on the noncompliance found at the September 1995 survey.

The November 30, 1995 notice then advised Petitioner that, at the November
1995 survey, the conditions in Petitioner’s facility had deteriorated to the point
that immediate jeopardy to residents existed at the facility. Id. at 2. Petitioner
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was advised that, as a consequence, Petitioner would be subject to remedies that
could include a civil money penalty of $7,500 per day. Id.

HCFA wrote to Petitioner on December 5, 1995. HCFA Ex. 8. The notice
directed Petitioner to file a plan of correction to address the deficiencies that
were identified at the November 1995 survey. HCFA warned Petitioner that
HCFA would terminate Petitioner’s participation in Medicare on December 27,
1995 if the immediate jeopardy to resident health and safety was not removed by
that date. HCFA also advised Petitioner that it might impose a civil money
penalty against Petitioner in the amount of $7,500 for each day that Petitioner
was not in substantial compliance with federal participation requirements. Id, at
2. HCFA stated that the penalty might be decreased if it found that “immediate
jeopardy has been removed but the non-compliance continues.” Id.

Petitioner filed a plan of correction with the Florida State survey agency on
December 12, 1995. HCFA Ex. 5, at 1; Attachment A. In filing its plan of
correction, Petitioner averred that it was not admitting that HCFA or the Florida
State survey agency were correct in finding deficiencies in Petitioner’s
operations. HCFA Ex. 5, at3. Nonetheless, Petitioner stated that it would
remedy the deficiencies that were identified in the report of the November 1995
survey by no later than December 14, 1995. Id, at 5 - 12.

On December 18 - 19, 1995, the Florida State survey agency conducted an
additional survey of Petitioner. HCFA Ex. 10. The surveyors concluded that, as
of those dates, Petitioner was complying substantially with all federal
participation requirements. Id. Based on this survey, HCFA determined that
Petitioner attained substantial compliance with federal participation requirements
on December 19, 1995.

On February 22, 1996, HCFA sent Petitioner the notice letter which is the basis
for Petitioner’s hearing request. HCFA Ex. 11. The notice letter refers to
HCFA’s December 5, 1995 letter to Petitioner. It gives Petitioner official notice
that HCFA had determined to impose a civil money penalty of $7,500 per day
against Petitioner, commencing on November 21, 1995 and continuing until
December 19, 1995.

Petitioner requested that the civil money penalty determination be reviewed under
an informal dispute resolution procedure. Informal dispute resolution procedures
in cases of remedies imposed against long-term care facilities are provided for by
42 C.F.R. § 488.331. On May 22, 1996, the Florida State survey agency
13

advised Petitioner that, as the result of the informal dispute resolution, it was
sustaining the findings made by the surveyors. HCFA Ex. 12. On August 23,
1996, the Florida State survey agency advised Petitioner that it was affirming the
results of the informal dispute resolution process. HCFA Ex. 17.

Il. Issues, findings of fact and conclusions of law
A. Issues
This case involves the following issues:

1. During the period from November 21, 1995 until December 19, 1995,
did Petitioner comply substantially with the federal participation
requirements stated in 42 C.F.R. § 483.25?

2. Is there a basis to impose a civil money penalty against Petitioner,
either in the upper or lower range of penalties, for Petitioner’s alleged
failure to comply substantially with the requirements of 42 C.F.R. §
483.25?

3. Am I authorized to order that a civil money penalty be imposed against
Petitioner for findings of deficiency in the November 1995 survey from
which HCFA did not make a determination to impose a civil money

penalty?

I make findings of fact and conclusions of law (Findings) which address these
issues. I set forth each Finding below as a separate italicized heading. I discuss
each Finding in detail.

B. Summary of my Findings

At the center of this case is the treatment that Petitioner gave to two of its
residents, Residents | and 5. Both of these residents are individuals who
suffered from debilitating chronic illnesses.

HCFA alleges that Petitioner failed to monitor the fevers experienced by
Residents | and 5 and failed to report these fevers to the residents’ treating
physician. In part, HCFA premises this allegation on assertions that Petitioner
was obligated to monitor fevers experienced by its residents at regular intervals
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and that Petitioner was obligated to report to the residents’ treating physician any
fever in excess of 101 degrees Fahrenheit.

HCFA argues that Petitioner consistently failed to monitor and report the fevers
experienced by Residents | and 5. HCFA asserts that this allegedly consistent
failure to monitor and report residents’ fevers evidenced a pervasive failure by
Petitioner to follow professionally accepted standards of care in reporting and
monitoring fevers. HCFA argues that these alleged systemic failures by
Petitioner posed a threat, not only to the welfare of Residents 1 and 5, but to the
welfare of all of Petitioners’ residents.

HCFA asserts that there is no persuasive evidence that Petitioner changed its
practices prior to December 19, 1995, when surveyors from the Florida State
survey agency concluded that Petitioner was in substantial compliance with all
participation requirements. From these assertions, HCFA argues that: (1)
Petitioner failed to comply substantially with the participation requirement stated
in 42 C.F.R. § 483.25; (2) Petitioner’s failure to comply with that requirement
posed immediate jeopardy to its residents; and (3) this alleged condition of
immediate jeopardy persisted until December 19, 1995.

HCFA argues from the foregoing assertions that there exists a basis to impose a
civil money penalty against Petitioner that falls within the upper range of civil
money penalties, of from $3,050 - $10,000 per day for the period from
November 20, 1995 until December 19, 1995. HCFA asserts that a civil money
penalty of $7,500 for each day during this period is justified, when Petitioner’s
alleged noncompliance with the requirements of 42 C.F.R. § 483.25 is
considered in light of the other findings of deficiencies made by the surveyors at
the November 1995 survey of Petitioner, under tags 272, 279, and 385.

I do not find HCFA’s determination to impose the penalty to be justified, for the
following reasons. First, HCFA has misstated the professionally accepted
standards of care which apply to a long-term care facility’s care of residents who
experience fevers. There is no standard of care that a long-term care facility
monitor a resident’s fever at preset intervals. Rather, the standard of care is that
a long-term care facility monitor a resident’s fever as often as may be medically
necessary to ensure that the fever is being assessed and treated. Nor do I agree
with HCFA’s allegation that professionally recognized standards of care require
that a long-term care facility report to a resident’s treating physician every
temperature that a resident manifests in excess of 101 degrees. The standard of
15

care is that a long-term care facility should report a fever when the fever
indicates a significant deterioration in the resident’s condition.

Second, Petitioner’s overall care of Residents 1 and 5 was not deficient when
measured against the applicable standards of care. I conclude that, by and large,
the professional staff of Petitioner was diligent in monitoring, treating, and
reporting the fevers of these two residents. The staff’s decisions to monitor and
report the residents’ fevers were motivated appropriately by the residents’
medical conditions, and the instructions for care that were given for these
residents.

That is not to say that Petitioner provided perfect care to its residents. I find
that, in the case of Resident 5, Petitioner’s staff erred in not reporting an episode
of fever to the resident’s treating physician. Although failure to inform the
physician potentially harmed the welfare of the resident, I am not persuaded that
the resident was harmed by this omission by Petitioner’s staff.

Third, there is no evidence in this case of a pervasive failure by Petitioner to
provide care to residents. There is no evidence that Petitioner was in any respect
deficient in its compliance with 42 C.F.R. § 483.25 during the period from
November 21, 1995 until December 19, 1995. Based on these conclusions, I
find no basis to impose a civil money penalty against Petitioner, either in the
amount of $7,500 per day, or for a lower amount, predicated on Petitioner’s
alleged failure to comply with the requirements of 42 C.F.R. § 483.25.

I make no findings concerning whether Petitioner complied substantially with
other participation requirements besides 42 C.F.R. § 483.25 during the period
from November 21, 1995 until December 21, 1995. HCFA did not determine to
impose any civil money penalty against Petitioner, based on the findings of
deficiency made by the surveyors who conducted the November 1995 survey,
under Tags 272, 279, and 385. I am without authority to decide whether a
remedy is authorized or reasonable where HCFA has not determined to impose a
remedy. Nor do I make any findings whether HCFA now could revisit the issue
of whether to impose a civil money penalty against Petitioner based on the
deficiencies identified under Tags 272, 279, and 385.

In their posthearing briefs and reply briefs, HCFA and Petitioner made numerous
arguments as to the significance of individual elements of the record of this case.
I have addressed the major arguments made by the parties in my Findings. The

fact that I have not addressed in the body of this decision each argument made by
16

the parties concerning the significance of an item of evidence should not be taken
to mean that I have ignored that argument. I have considered every argument
that the parties made. However, I have elected not to discuss in detail each
argument that the parties made on minor points, for purposes of efficiency.

C. Findings

1. It is reasonable to interpret 42 C.F.R. § 483.25 to require a
long-term care facility to monitor adequately the temperatures of
those residents who suffer from fevers and to report the elevated
temperatures of residents to the residents’ physicians when it is
medically appropriate to do so.

The regulation on which HCFA predicates its determination that Petitioner failed
to comply with a federal participation requirement to the extent that Petitioner’s
noncompliance posed immediate jeopardy to its residents is 42 C.F.R. § 483.25.
The regulation states in its preamble that:

Each resident [of a long-term care facility] must receive and the
facility must provide the necessary care and services to attain or
maintain the highest practicable physical, mental, and psychosocial
well-being, in accordance with the [resident’s] comprehensive
assessment and plan of care.

The regulation contains subsections (a) through (m) which describe specific types
of care that a long-term facility must provide and which describe the manner in
which the facility must provide such types of care.

The broad requirements of 42 C.F.R. § 483.25 implicitly include a requirement
that a facility adhere to professionally recognized standards of care in providing
care and treatment to its residents. As I discuss at Finding 2, the professionally
recognized standards of care which apply to a long-term care facility include
standards which govern the medically appropriate monitoring and reporting of
residents’ fevers.

The regulation does not specifically address, either in its preamble or in
subsections (a) through (m), the circumstances under which a facility must
monitor a resident’s temperature or the circumstances under which a facility must
report a resident’s elevated temperature to the resident’s treating physician.
However, I find it to be evident that a resident’s fever, if not treated adequately
17

by a facility, may prevent the resident from attaining his or her highest
practicable level of physical or mental well-being.

2. The implied requirement in 42 C.F.R. § 483.25 that a facility
monitor and, when medically indicated, report a resident’s fever to
the resident’s treating physician, does not generally require a
facility to monitor every resident’s fever at preset intervals, nor
does it require a facility to report a resident’s fever to the
resident’s physician whenever the fever exceeds 101 degrees
Fahrenheit.

a, The temperature monitoring requirement that is
incorporated in 42 C.F.R. § 483.25 is the
professionally recognized standard of care that a
nursing home’s professional staff monitor a
resident’s fever as often as the resident’s medical
condition warrants monitoring.

b. The temperature reporting requirement that is
incorporated in 42 C.F.R. § 483.25 is the
professionally recognized standard of care that a
nursing home’s professional staff report to a
resident’s treating physician any change in the
resident’s temperature that indicates a medically
significant deterioration in the resident’s condition.

HCFA’s case for asserting that Petitioner failed adequately to monitor and report
the fevers manifested by its residents rests on two premises. First, HCFA argues
that, when a resident of a long-term facility manifests a fever, it is the duty of
the facility to monitor that fever by taking the resident’s temperature at preset
intervals. Second, HCFA asserts that a facility should report to a resident’s
treating physician every elevated temperature manifested by a resident which
exceeds 101 degrees Fahrenheit.

a. The circumstances under which Petitioner has
a duty to monitor a resident’s fever

The report of the November 1995 survey did not state that the State survey
agency surveyors expected Petitioner to monitor a resident’s fever at preset
intervals when a resident manifests a fever. The first notice that Petitioner
18

received that this asserted requirement was a predicate for the surveyors’ findings
came in a notice dated May 22, 1996 that Petitioner received from the Florida
State survey agency. HCFA Ex. 12. That notice reported to Petitioner the
results of informal dispute resolution concerning the scope and severity findings
of the surveyors, made at the November 1995 survey, on which HCFA based its
determination to impose a $7,500 per day civil money penalty against Petitioner.
The notice recited, as part of the rationale for sustaining the findings of the
surveyors, that:

According to our surveyors, the standard of [practice] is to monitor
elevated temperatures every four hours. The record for Resident #5
indicates that there were greater than 12 hours between temperature
checks during some of the occasions when this resident’s
temperature was high and therefore aggressive treatments were
delayed.

Id. at 1.

It is reasonable to infer from this notice that one element of the Florida State
survey agency’s findings of deficiency under Tag 309 was that Petitioner was not
complying with an asserted standard of practice that it monitor its residents’
fevers at four-hour intervals. Petitioner devoted considerable effort at the
hearing to rebut this assertion.

HCFA now argues, in its reply brief, that it is not asserting that there is a
standard of care applicable to long-term care facilities which requires that a
facility monitor a resident’s fever at four-hour intervals. HCFA’s reply brief at
10. I am puzzled by this argument, inasmuch as HCFA made no effort to
correct the Florida State survey agency’s assertion that such a standard existed
and that Petitioner failed to comply with it. See P. Ex. 12. Petitioner presented
substantial evidence at the March 25 - 26, 1997 hearing to refute the existence of
an asserted once per four hours monitoring standard. At no time during the
hearing did HCFA suggest that this evidence was not relevant or that is was
unnecessary.

What makes HCFA’s statement that it is not relying on an asserted once per four
hours monitoring requirement even more puzzling is that HCFA has not made an
affirmative assertion, other than the abandoned once per four hour assertion, as

to what a facility’s monitoring requirement is. Therefore, HCFA is arguing that
Petitioner failed adequately to monitor its residents’ fevers, but it is not asserting
19

affirmatively, the ‘standard of care that Petitioner was obligated to comply with in
monitoring its residents’ fevers.

I find that the professionally recognized standard of care for monitoring of a
resident’s fever in a long-term care facility is that the resident’s temperature
should be monitored as often as is warranted by that resident’s condition. There
is no professionally recognized standard of care which requires a long-term care
facility to monitor a resident’s temperature at standardized minimum time
intervals except in the case of a resident who is receiving antibiotic therapy. In
such a case, the standard is to monitor the resident’s temperature once per eight
hour nursing shift. These standards are incorporated impliedly into 42 C.F.R. §
483.25 as standards that should be followed by a long-term care facility in order
to ensure that a resident achieve the highest practicable physical and mental well-
being.

HCFA did not offer evidence at the hearing of this case that would support any
monitoring standard. Petitioner offered evidence which proved that, in a long-
term care facility, the general standard of care is to check the temperature of a
resident once every eight-hour shift, where the resident is on antibiotics. Tr. at
264. This comports with the standard of care for nurses in acute care hospitals.
There, the general standard of care for monitoring fevers is to check a patient’s
fever once every eight-hour shift when the patient is receiving antibiotics. Id.
Only in a hospital intensive care unit is a once every four hours standard
maintained for monitoring a patient’s fever. Id, at 265. This evidence was
supplied credibly, by Susan Watts, R.N., whose professional experience includes
service as a director of nursing at an 180-bed long term care facility, and as a
nurse in hospital intensive care units. Tr. at 242. It was not rebutted by HCFA.

Ms. Watts’ testimony was corroborated by the testimony of Ralph Page, M.D.
Tr. at 349. Dr. Page was retained by Petitioner as an expert physician. Dr.
Page is board certified in internal medicine, with additional credentials in internal
medicine. Tr. at 313. A major portion of Dr. Page’s practice includes caring
for elderly patients. Id, at 315. Dr. Page is the medical director of two nursing
homes and the assistant medical director of a third nursing home. Id. at 315 -
316. I find that his expert opinion on this issue and on other issues, as well, to
be credible and essentially unrebutted by HCFA.
20

It is the thrust of the testimony offered by Ms. Watts and Dr. Page that what is
done for a resident in a long-term care facility ought to depend on the individual
needs of that resident, and not on any predetermined or rigid criteria. See Tr. at
331 - 332; 337 - 340. This flexible standard of care incorporates a requirement
that a long-term care facility should monitor a resident’s temperature once per
nursing shift, when the resident is on antibiotics. Tr. at 249; 264 - 266.

The treating physician for Resident 5 throughout her two stays at Petitioner’s
facility was Ernest deLeon, M.D. P. Ex. 10. Dr. deLeon is the medical
director of Petitioner’s facility. Id. at 1.

HCFA argues that an order given by Dr. deLeon for the administration of
Tylenol to Resident 5 in order to control the resident’s fever implicitly
acknowledged a need to monitor the resident’s fever at four-hour intervals.
HCFA’s posthearing brief at 28 - 29; see P. Ex. 8, at 13. I am not persuaded
that the order at issue directed Petitioner’s staff to monitor the resident’s
temperature at four-hour intervals. The order empowers the staff to administer
Tylenol as needed by the resident at intervals as brief as once every four hours.
P. Ex. 8, at 13; Tr. at 138. It is an order which gives the nursing staff an option
to administer medication, not a directive. Id, It neither states nor suggests that
monitoring at four-hour intervals was contemplated by Dr. deLeon.

b. The circumstances under which Petitioner has
a duty to report a resident’s fever to a resident’s
treating physician

The report of the November 1995 survey plainly suggests that the surveyors
considered it to be mandatory that a resident temperature in excess of 101
degrees Fahrenheit be reported to a resident’s treating physician. At several
places in their description of Petitioner’s alleged failure to comply with the
requirements of 42 C.F.R. § 483.25, the surveyors assert that a resident
manifested a temperature in excess of 101 degrees, but that Petitioner’s
professional staff failed to report the resident’s temperature to the resident’s
treating physician. HCFA Ex. 5, at 8, 9, 10.

I do not find that professionally recognized standards of care, as they are
incorporated into 42 C.F.R. § 483.25, require a long-term care facility to report
every temperature of a resident in excess of 101 degrees. There is no specific
temperature which triggers a reporting requirement. I find that the professionally
recognized standard of care which is incorporated into 42 C.F.R. § 483.25 is that
21

a long-term facility report a resident’s temperature when that temperature
indicates a medically significant deterioration in the resident’s condition. What is
significant depends on the unique circumstances which pertain to each individual
resident.

HCFA’s principal witness concerning the professionally recognized standards of
care which govern long-term care facilities was Mr. Charles Fuller, R.N. Mr.
Fuller was one of the surveyors who participated in the November 1995 survey
of Petitioner. He has a nursing background, which includes working as a head
nurse at a skilled nursing facility for a large hospital. Tr. at 47. Mr. Fuller
testified that, in his experience as a nurse in long-term care facilities, such
facilities had protocols which required that physicians be contacted routinely
where residents’ temperatures exceeded 101 degrees. Tr. at 69.

Petitioner rebutted Mr. Fuller’s testimony by offering the professional opinion of
Dr. Page. The credible testimony of Dr. Page is that the professionally
recognized standard of care for physician notification by a long-term care facility
of a resident’s elevated temperature does not encompass a rigid requirement that
a physician should be notified when a resident’s temperature exceeds 101
degrees. Tr. at 330. Notification should be made where an elevated temperature
is a sign of a significant decline in a resident’s status. Tr. at 329 - 330. What is
significant varies from resident to resident. In the case of a resident who has
been experiencing normal temperatures, a spike in that resident’s temperature
might be a significant change in the resident’s status which necessitates contacting
the resident’s physician. Tr. at 329. By contrast, frequent notification of a
physician of temperature increases might not be appropriate where a resident
chronically runs a fever. Tr. at 330.

I find the most persuasive evidence as to the standard of care which governs
when a nursing facility should contact a resident’s treating physician in the event
of an elevated temperature in a resident to be the testimony given by Dr. Page. I
find Dr. Page’s explanation of the standard of care to be more persuasive than
that given by Mr. Fuller, for two reasons. First, Dr. Page’s qualifications as an
expert are stronger than those of Mr. Fuller. Dr. Page is a physician who
specializes in geriatric care and the medical director of two nursing homes.
Second, and more important, Dr. Page gave a coherent explanation of the
circumstances under which a nursing home should report a resident’s elevated
temperature. By contrast, Mr. Fuller merely recited the asserted requirement
that every temperature in excess of 101 degrees must always be reported, without
22

explaining why, as a matter of practice, a temperature in excess of 101 degrees
should always be reported.

HCFA seeks to buttress its assertion that Petitioner was obligated under
applicable standards of care to report every resident temperature in excess of 101
degrees with evidence that Petitioner maintained a protocol that required its staff
to report temperatures in excess of 101 degrees. HCFA Ex. 5, at 11. Petitioner
does not deny that, as of the November 1995 survey, it had a protocol which
required its nurses to contact a resident’s treating physician when the resident’s
temperature exceeded 101 degrees. Tr. at 293 - 294. Petitioner does not deny
that its staff failed to follow this protocol. Nor does Petitioner dispute the
possibility that Mr. Fuller’s professional experience may have involved working
at long-term care facilities which had similar protocols. However, Petitioner
asserts that the protocol does not embody professionally recognized standards of
care. Indeed, Petitioner discontinued the protocol after the November 1995
survey. Tr. at 297 - 299.

I do not find that Petitioner’s failure to follow its protocol concerning physician
notification in the event of an elevated temperature in a resident to be persuasive
evidence that Petitioner did not follow a professionally recognized standard of
care in its treatment of Residents 1 and 5. The protocol, which required
Petitioner’s staff to report a resident’s temperature of more than 101 degrees,
does not comport with a professionally recognized standard of care for reporting
fevers.

As HCFA concedes, failure by a facility to comply with a protocol is not a
failure to comply with a participation requirement where the protocol does not
comport with a professionally recognized standard of care and where the
participation requirement does not direct a facility to follow each of its internal
protocols. HCFA’s reply brief at 12 - 13. Failure by Petitioner to follow the
protocol would be significant here only if the protocol contained a professionally
recognized standard of care or if the protocol stated a federal participation
requirement for a long-term care facility.

HCFA’s assertion that there exists a professionally recognized standard of care
which requires a facility to report to a resident’s treating physician every
temperature of that resident that exceeds 101 degrees is undercut by the fact that
Petitioner’s plan of correction, which it submitted in response to the November
1995 survey, did not represent that Petitioner would adhere to this asserted
requirement. See HCFA Ex. 5. Petitioner proposed to implement an acute care
23

charting system which gave explicit instructions to nurses concerning the care to
be provided to residents who suffered from acute illnesses. See Id, at 8.
Petitioner pledged to intensively monitor residents with acute illnesses. See Id.
What Petitioner proposed to do, and HCFA accepted, is consistent with the kind
of monitoring and reporting that Dr. Page testified would be appropriate. The
fact that HCFA accepted a plan of correction which did not bind Petitioner to
report every resident temperature in excess of 101 degrees at least suggests that
HCFA did not consider the asserted reporting standard to be a mandatory
requirement that long-term care facilities follow.

3. The method by which Petitioner measured residents’
temperatures is not relevant to my decision.

In some respects, the surveyors premised their allegations concerning Petitioner’s
alleged failure to report residents’ fevers to the residents’ treating physician on an
assertion that the fevers that Petitioner’s staff recorded are actually lower than the
true temperatures that the residents were running at the time. This assertion is in
turn predicated on the allegedly different temperature readings that result from
different methods of taking temperatures. Petitioner does not dispute that
different methods of taking temperature may produce different readings at the
same time in the same individual. However, Petitioner disagrees with the State
survey agency and HCFA as to the span of temperatures that may be expected
from different temperature recording methods.

There is no dispute that there are three generally accepted ways to take an
individual’s temperature. These are: orally; rectally; and axillary (recorded by
placing a thermometer under the individual’s arm). Tr. at 58 - 59. HCFA’s
witness, Mr. Fuller, testified that an oral temperature reading is usually one
degree higher than is an axillary temperature reading taken at the same time, and
a rectal temperature reading is usually one degree higher than is an oral
temperature reading taken at the same time. Id, Thus, according to Mr. Fuller,
one might expect a two-degree difference between an axillary and a rectal
temperature.

Petitioner offered P. Ex. 16 to rebut this testimony. It is an excerpt from a
medical treatise which states that an oral temperature is usually about one-half
degree higher than is an axillary temperature that is taken at the same time, and
that a rectal temperature is usually about one-half to one degree higher than is an
oral temperature that is taken at the same time. P. Ex. 16, at 3. Therefore,
according to Petitioner’ treatise excerpt, an individual’s temperature span will
24

vary between one-and one and one-half degrees, depending on the method of
taking the temperature, and not two degrees, as is averred by HCFA. Id.

I find this dispute largely to be irrelevant to my decision. The most accurate
temperature of a resident might be important if I were to find that a facility was
obligated to report automatically a resident’s true temperature in excess of 101
degrees to the resident’s treating physician. If that were the standard, then the
method by which the resident’s temperature is recorded might be significant in
telling the facility whether the resident’s actual body temperature is above 101
degrees. Based on HCFA’s evidence, an axillary temperature of 99.5 degrees
would translate to a rectal temperature of 101.5 degrees. Based on Petitioner’s
evidence, an axillary temperature of 99.5 degrees would translate to a rectal
temperature of either 100.5 degrees or 101 degrees.

But, as I find above, at Finding 2, there is no standard of care that requires a
facility automatically to report a temperature of more than 101 degrees toa
resident’s treating physician. Therefore, the fact that a resident’s temperature
might be above 101 degrees, depending on the method by which that temperature
is taken, is not significant to my decision.

What is significant is whether a resident manifests a temperature change that
establishes a significant deterioration in the resident’s condition. No party
disputes that such a change may be recorded by any of the accepted ways of
taking an individual’s temperature.

4. Petitioner followed professionally recognized standards of care
in providing care to Resident 5.

The surveyors who conducted the November 1995 survey of Petitioner reviewed
the records of two stays at Petitioner’s facility by Resident 5. The first stay was
from September 6, 1995 until September 27, 1995. P. Ex. 7, at 1 - 99. The
second stay was from November 3, 1995 until November 14, 1995. P. Ex. 8, at
1 - 48.

Resident 5 began her first stay at Petitioner’s facility with a discharge to the
facility from a local hospital, Lake City Medical Center. P. Ex. 7, at 6. At the
time of her first admission to Petitioner’s facility, the resident was diagnosed to
be suffering from a low grade fever. Id, The resident’s other diagnoses
included: urinary tract infection, viral syndrome, obs (which I infer to be
25

organic brain syndrome) status post CVA, decubitus ulcers, mild congestive heart
failure, and diabetes mellitus. Id.

On September 27, 1995, Resident 5 was transferred from Petitioner’s facility to
Lake City Medical Center. Her diagnoses at the time of her transfer included
left lower lobe pneumonitis. P. Ex. 8, at 7. On October 11, 1995, Resident 5
was transferred from Lake City Medical Center to Vencor Hospital. Id, The
resident remained at Vencor Hospital until November 3, 1995, when she was
transferred back to Petitioner’s facility. The resident’s diagnoses at the time of
her transfer back to Petitioner’s facility included: left lower lobe pneumonitis,
resolved; urinary tract infection, yeast, resolved; decubitus ulcers, stage III - IV
right hip, ongoing treatment; hypertension; adult onset diabetes mellitus;
arteriosclerotic heart disease with congestive heart failure; anemia of chronic
disease; dementia, status post cerebrovascular accident, remote; staph sepsis,
resolved. Id.

The overall allegation of deficiency which the surveyors made and HCFA
adopted concerning the care which Petitioner provided to Resident 5 during her
two stays at Petitioner’s facility is that Petitioner did not consistently monitor the
resident’s status to identify changes in her condition which could have resulted in
harm to the resident or deterioration in the resident’s condition. HCFA Ex. 5, at
8. The surveyors and HCFA allege that Petitioner did not react in response to
the resident’s identified conditions or to changes in the resident’s conditions. Id.
They assert that these alleged failures by Petitioner to react could have led to
harm to the resident or deterioration in the resident’s condition. Id,

HCFA implicitly adopted the surveyors’ general and specific allegations in
determining to impose a civil money penalty against Petitioner. In their report of
the November 1995 survey, the surveyors amplify on these assertions by averring
that on many occasions the resident was noted to have a fever in excess of 101
degrees and on one occasion was noted to be in respiratory distress. Id. The
surveyors assert that Petitioner failed to notify the resident’s treating physician of
these allegedly potentially harmful changes in the resident’s condition. Id. The
surveyors’ general statement of alleged failures by Petitioner to provide proper
treatment to Resident 5 is followed by four specific examples, listed as examples
a) through d).

The evidence which the parties offered concerning these allegations of
noncompliance includes the report of the November 1995 survey, the testimony
of Mr. Fuller, the surveyor who performed the review which led to the
26

allegations about Resident 5, the resident’s treatment records, the affidavit
testimony of Dr. deLeon, and the opinions of Ms. Watts and Dr. Page. I
conclude from all of this evidence that the preponderance of the evidence is that
Petitioner complied with professionally recognized standards of care in providing
care to Resident 5. Specifically, I conclude that Petitioner monitored adequately
the fevers that the resident manifested on various occasions, and, with an
exception that I shall discuss, reported significant changes in the resident’s
condition to Dr. deLeon. It is apparent also from the evidence that Petitioner’s
professional staff, under the direction of Dr deLeon, gave treatments to the
resident that were appropriate, within the limitations of the treatment regime
ordered for that resident.

As is apparent from the discussion which follows, I have relied heavily on the
testimony of Dr. Page, not only for his description of the standards of care which
apply to monitoring and reporting of a resident’s temperature, but for his analysis
of whether the care rendered by Petitioner’s staff was within applicable
standards. Dr. Page is the only expert physician who testified in person at the
hearing which I conducted. HCFA did not rebut directly any of the testimony
that Dr. Page offered.

At the in-person hearing, HCFA suggested that Dr. Page’s testimony might be
discounted by virtue of the fact that Dr. Page is a paid expert. I am not satisfied
that the fact that Dr. Page was compensated for his testimony is a basis to
discount that testimony. HCFA did nothing to impeach Dr. Page’s credibility,
aside from suggesting that his testimony was motivated by the compensation he
received for it.

a. Example a)

The surveyors stated example a) of alleged failure by Petitioner to provide proper
monitoring and reporting of the fevers manifested by Resident 5 as follows:

The resident was documented at 2:20 PM on 12-Sep-95 to have a
fever of 99.5 axillary and at 12:10 AM on 13-Sep-95 was noted
clammy, dusky with discoloration of the lower extremities and 3 +
edema. The physician was notified eleven (11) hours later at 11:15
Am on 13-Sep-95 of the changes in the resident’s condition.

HCFA Ex. 5, at 8 - 9.
27

Nowhere in the survey report do the surveyors explain what was inappropriate
about the care in example a) that Petitioner provided to the resident. However, I
am inferring from the example that the surveyors found that the fever of 99.5
axillary on September 12 should have been reported to Dr. deLeon. I am
inferring also that the surveyors concluded that the medical signs of clamminess,
duskiness, discoloration, and edema that the professional staff observed early on
the morning of September 13, were signs of respiratory distress of which Dr.
deLeon should have been notified immediately.

I conclude that the care that Petitioner provided to Resident 5 between September
12 and 14, 1995, comports with professionally recognized standards of care for
monitoring and treating fevers and reporting to the resident’s treating physician
changes in a resident’s condition. Example a) does not demonstrate a failure by
Petitioner to provide care to Resident 5 which comports with professionally
recognized standards of care.

The monitoring of the resident’s fever that Petitioner’s professional staff did is
within the standard of care for monitoring of fevers. Resident 5 was suffering
from an ongoing viral condition for which she was receiving antibiotics. P. Ex.
7, at 7; Tr. at 249. During the period beginning on September 12, and ending in
the early morning hours of September 14, the resident ran a fever. P. Ex. 7, at
15 - 17. Petitioner’s staff recorded the resident’s temperature at least once per
nursing shift. Id. This is consistent with that which would be done in an acute
care facility for a patient who is suffering from a fever and who is receiving
antibiotics. Tr. at 264.

Petitioner’s staff recognized and treated appropriately the elevated temperatures
manifested by Resident 5. In an effort to reduce the resident’s fever, the staff
administered Tylenol elixir to the resident at regular intervals. P. Ex. 7, at 15 -
16. HCFA has offered no evidence that the treatment provided for the resident’s
fever was inappropriate, nor has HCFA averred that there were other treatments
that Petitioner ought to have administered, but which Petitioner did not
administer. Mr. Fuller, who is HCFA’s witness, agreed that administration of
Tylenol is an appropriate way to reduce a fever. Tr. at 113. Dr. Page
concluded that the treatment which Petitioner gave to the resident for her fever
was appropriate. Tr. at 325 - 332.

Petitioner’s staff treated the resident’s respiratory distress diligently,
appropriately, and successfully. There is no evidence that Petitioner was in any
respect derelict in the care it gave for the respiratory distress of Resident 5.
28

HCFA has not offered evidence to show that Petitioner’s treatment of the
resident’s respiratory distress was inappropriate. By contrast, Petitioner offered
unrebutted, persuasive evidence that Petitioner treated the resident’s respiratory
distress appropriately and effectively. That evidence consists of the results that
Petitioner’s staff obtained in treating Resident 5 along with the testimony of Ms.
Watts and Dr. Page. P. Ex. 7, at 16; Tr. at 252; 325 - 332.

The resident manifested signs of respiratory distress at 12:10 am on September
13. These signs included the clamminess, duskiness, and edema that were
reported by the surveyors. P. Ex. 7, at 16. They also included observations that
rales could be heard at the bases of the resident’s lungs. Id. The nursing staff
suctioned the resident at 3:15 am on September 13. After suctioning, the
resident’s respiration was noted to be improved, without signs of further labored
breathing. Id. A chest x-ray was taken of the resident as part of the care
provided for the resident’s respiratory distress. The results of the x-ray were
received at 1:00 pm on September 13, 1995, and showed the patient to be
without pneumonia and with reduced pleural effusion. Id.

Professionally recognized standards of care did not require that Petitioner notify
Dr. deLeon of the resident’s condition before 11:15 am on September 13, 1995.
At no point during the episode which began on September 12, 1995, did the
resident’s status deteriorate to the extent that notification was mandated. The
notification that was given to Dr. deLeon on September 13 was, in fact, a routine
status update, and not a notification of a marked change in the resident’s
condition. Tr. at 254.

As I hold above, there is no professionally recognized standard of care that
would require Petitioner to notify a physician of a resident’s fever once that fever
exceeded 101 degrees. The standard of care, either in the case of a fever or in
the case of other problems, such as respiratory distress, is to notify a resident’s
physician of any change in the resident’s condition which shows a significant
deterioration in that resident’s condition. Here, the evidence shows that the fever
and the respiratory problems that the resident displayed between September 12
and September 13 were part of an ongoing, previously diagnosed condition for
which Dr. deLeon had prescribed treatment. There were no changes in the
resident’s condition which mandated that Dr. deLeon be notified.

I draw this conclusion essentially from the unrebutted testimony of Dr. deLeon
and Dr. Page. In his affidavit, Dr. deLeon avers that he would not have changed
the treatment orders that he gave for Resident 5 had he been notified sooner by
29

Petitioner’s staff of elevations in the resident’s temperature. P. Ex. 10, at 2.
His testimony does not specifically address HCFA’s example a), but I infer that
it includes this example along with the other examples cited by HCFA.

Dr. Page reviewed the care that Petitioner provided to Resident 5 on the 12th and
13th of September 1995, and concluded that the care was appropriate, given the
nature of the resident’s condition. Tr. at 325 - 332. Dr. Page’s opinion of the
care provided by the facility was that the facility was doing all that could
reasonably be expected for the resident, given the resident’s state of health. Id.
He concluded, additionally, that there was no particular reason why the facility
would have been obligated to notify Dr. deLeon immediately of the increase in
the resident’s temperature, given the resident’s condition. Tr. at 331 - 332.

HCFA asserts that Dr. deLeon has an interest in the outcome of this case which
affects the credibility of his testimony. To be sure, Dr. deLeon, as the resident’s
treating physician, has an interest in defending the care that he provided to the
resident. But Dr deLeon’s self-interest does not disqualify his testimony. A
witness may have an interest in the outcome of a proceeding and yet, deliver
credible testimony. Here, there is nothing to show that Dr. deLeon’s testimony
is medically unsupported. Dr. deLeon’s testimony is unrebutted. Moreover, it is
supported by the testimony given by Dr. Page.

b. Example b)

The surveyors stated example b) as follows (for the sake of clarity, I am omitting
a list of temperature readings and treatments that are part of the example):

The resident had multiple (10) temperature[s] checked between 8:30
PM on 23-Sep-95 (103 degrees rectal) and 1:30 AM on 25-Sep-95
(101 degrees) which were documented greater than 101 degrees. . .
. The resident maintained a fever greater than 101 degrees for 42
hours during which there is no documentation that the resident’s
physician was notified of the resident’s decline in physical well-
being until 3:00 PM on 25-Sep-95. The resident’s physical well-
being continued to decline and the resident was transferred to the
hospital at 2:15 PM on 27-Sep-95 with oxygen saturation level of
77% and fever of 105.9 R.

HCFA Ex. 5, at 8 - 10.
30

It is clear that the- surveyors intended the example to show that Petitioner failed
to report to Dr. deLeon a potentially dangerous change in the condition of
Resident 5. It is not clear whether HCFA relies on the example also as evidence
that Petitioner failed to monitor the resident’s fever, or as an evidence that
Petitioner failed adequately to treat the resident’s fever. I have considered the
evidence which is relevant to this example in terms of what it shows about how
Petitioner monitored, treated, and reported the resident’s fever to Dr. deLeon.

The surveyors’ allegations in example b) contain errors of fact and a description
of events which inflate the allegations by the surveyors that Petitioner was
derelict in providing care to Resident 5. First, the surveyors assert, incorrectly,
that Petitioner’s temperature exceeded 101 degrees during a 42 hour period prior
to 3:00 pm on September 25, 1995, during which Dr. deLeon allegedly was not
notified of the resident’s condition. HCFA Ex. 5, at 9. In fact, the period
during which the resident’s temperature exceeded 101 degrees, and during which
there was no documented communication with Dr. deLeon, began at 2:45 pm on
September 24 and ended at 7:25 am on September 25. P. Ex. 7, at 20 - 21.

Second, in asserting that the resident was transferred to the hospital on
September 27, with an oxygen saturation level of 77% and a temperature of
105.9, measured rectally, the surveyors seem to link the patient’s transfer, in
part, to the resident’s high fever. See HCFA Ex. 5, at9- 10. Although I am
certain that the resident’s continued fever contributed to Dr. deLeon’s decision to
order that the resident be transferred, the resident’s fever was not the principal
motivating reason for the transfer order. In the hours prior to Dr. deLeon’s
decision to transfer the resident, the resident’s fever had, in fact, been reduced
substantially. P. Ex. 7, at 22. The decision to transfer the resident was based
on the decline in the resident’s oxygen saturation level, coupled with evidence of
blood clots in the resident’s catheter. Id. The resident’s fever rose to a high
level after the decision had been made to transfer the resident. Id,

Indeed, the evidence shows that Petitioner’s staff reacted swiftly to a final spike
in the resident’s temperature on September 27 which occurred after Dr. deLeon
issued an order to transfer the resident. P. Ex. 7, at 23. In order to save time,
Petitioner’s staff contacted 911 and arranged for an expedited transfer of the
resident. Id,
31

My conclusions about example b) are that facts related to this example establish
that, in general, Petitioner complied with professionally recognized standards of
care in the monitoring and treatment that it provided for the fever and related
problems manifested by Resident 5. Petitioner’s staff adequately monitored and
aggressively treated the resident’s fever. I find that Dr. deLeon was in frequent
contact with Petitioner’s staff during the episode in question, and was well aware
of the resident’s general condition, including her persistently elevated fever.

Although I find a general compliance by Petitioner with standards of care, I find
that Petitioner’s staff must be faulted for-not reporting to Dr. deLeon a serious
elevation of the resident’s temperature, which occurred on September 24, 1995.
However, that is the only judgment error that I find concerning the course of
treatment that Petitioner provided to the resident between the 23rd and 25th of
September 1995. I do not find that this error in judgment resulted in harm to the
resident. It is an isolated event, and does not typify the care that Petitioner
provided to Resident 5.

The evidence does not show Petitioner’s staff to have been derelict in
communicating with Dr. deLeon concerning the condition of Resident 5. To the
contrary, the record establishes frequent communications between Petitioner’s
staff and Dr. deLeon concerning the resident’s condition. The communications
concerning the resident’s persistent fever began on September 18, 1995. P. Ex.
7, at 18. On that date, Petitioner’s nursing staff notified Dr. deLeon of the
resident’s “repeatedly elevated temperature.” Id. Dr. deLeon responded to this
notification by ordering that blood cultures be taken of the resident. Id. The
reason that Dr. deLeon ordered blood cultures of Resident 5 was to diagnose the
cause of the resident’s fever and to give Dr. deLeon evidence on which he could
base a treatment plan. See Tr. at 115. Laboratory results were received on
September 20, and Dr. deLeon was notified of these results. P. Ex. 7, at 19.

There was an additional communication between Petitioner’s staff and Dr.
deLeon concerning laboratory results on September 21, 1995. P. Ex. 7, at 19.
On September 22, 1995, Petitioner’s staff spoke again with Dr. deLeon
concerning the resident’s condition (the specific subject of this discussion was the
resident’s decubitus ulcers). Id. at 20.

Dr. deLeon visited the resident on September 23, 1995, and issued new treatment
orders on that date. Id, Additional communications with Dr. deLeon were
recorded on September 25, 1995, concerning the results of laboratory tests. Id,
at 21. The nursing notes record another communication with Dr. deLeon, by
32

telephone, on September 26, 1995, to report the results of blood cultures. Id.
On September 27, additional laboratory results were received. On that date, the
nursing staff informed Dr. deLeon of a decline in the resident’s condition. Id, at
22. Dr. deLeon ordered the resident be transferred to the hospital on that date,
for evaluation. Id,

It is true that, during the days between September 18, and September 27, not
every temperature reading of Resident 5 in excess of 101 degrees was
communicated to Dr. deLeon. But, as I find above, there is no professionally
recognized standard of care that would have required Petitioner to notify Dr.
deLeon of every temperature manifested by the resident that exceeded 101
degrees. Rather, Petitioner’s obligation was to make sure that Dr. deLeon was
kept apprised of the resident’s overall condition and of any changes in that
condition that showed significant deterioration in the resident’s status.

In general, this requirement was met by Petitioner’s staff. There was no failure
by Petitioner to keep Dr. deLeon apprised of the resident’s ongoing and
persistent fever, nor was there any failure by the facility to be diligent in
communicating with Dr. deLeon concerning the treatment of the fever. Dr.
deLeon was well aware of the resident’s fever. P. Ex. 10, at 2. He addressed
her fever by ordering blood cultures, prescribing antibiotic therapy, and issuing
orders for the care of the resident.

There is evidence that, on one occasion, on September 24, 1995, the resident's
fever was markedly elevated and Dr. deLeon was not notified of that event. On
the evening of September 24, the resident’s temperature rose to 105.1 degrees,
measured rectally. P. Ex. 7, at 20. The nursing staff diligently treated the
fever, with Tylenol and ice packs. Dr. deLeon was not notified of this specific
event.

I conclude that the rise in the resident’s temperature on September 24, 1995, was
an event of which Dr. deLeon ought to have been notified by Petitioner’s staff.
Although the resident had run persistent fevers prior to that date, the temperature
of 105.1 was markedly higher than any previously recorded temperature.
Petitioner’s own witness, Ms. Watts, agreed that Dr. deLeon should have been
notified of this increase in temperature, because a temperature of that degree of
elevation posed a risk for harm to the resident. Tr. at 258.
33

Although failure to inform the physician potentially harmed the welfare of the
resident, I do not find that the resident was harmed by this single failure of
Petitioner’s staff to notify Dr. deLeon of the resident’s temperature. In its reply
brief, HCFA asserts that the clinical signs manifested by the resident at midnight
on September 24, 1995, were consistent with neurological damage produced by
fever. HCFA’s reply brief at 5. However, HCFA has offered no credible
opinion evidence, nor has HCFA cited to findings in the resident’s record, which
show that the resident actually suffered harm from the episode of high fever that
the resident sustained on September 24, 1995. The treatment that Petitioner gave
for the elevated temperature, Tylenol and ice packs, was the medically indicated
treatment. Tr. at 258; see Tr. at 113. The resident’s fever was reduced. P. Ex.
7, at20 - 21. HCFA has not asserted that there were other treatments that
Petitioner might have given to the resident, which it failed to give to the resident.

I find to be appropriate the care that Petitioner gave to the resident through
September 27, 1995. Petitioner’s staff monitored the resident’s temperature
frequently. P. Ex. 7, at 20 - 23. When the resident’s temperature was elevated,
Petitioner’s staff treated the fever aggressively. Treatments included frequent
administration of Tylenol elixir and ice packs. Id. This was the medically
appropriate course of care to address the resident’s fever. Tr. at 258; see Tr. at
113. Dr. deLeon testified without rebuttal that he would not have changed the
monitoring or the treatment provided to Resident 5 by Petitioner’s nursing staff.
P. Ex. 10, at 2. HCFA has not asserted that the resident should have been given
treatments other than those which Petitioner’s staff administered to the resident.

I find strong support in the testimony of Dr. Page for my conclusion that
Petitioner’s staff and Dr. deLeon cared for Resident 5 through September 27,
1995 consistent with that which was required by professionally recognized
standards of care. Dr. Page concluded that the monitoring provided to the
resident by Petitioner’s nursing staff equaled or exceeded that which was required
by applicable standards of care. Tr. at 338 - 339. Dr. Page noted that the
purpose of antibiotics is to treat a possible source of the resident’s fever.
However, antibiotic therapy does not produce immediate results. Tr. at 333 -
336. It would not have been realistic to expect an immediate reduction in the
resident’s fever after antibiotics were administered. Id. And, in light of the fact
that Dr. deLeon was aware of the resident’s persistent fever, notification of Dr.
deLeon of every increase in the resident’s temperature was unnecessary. Tr. at
337 - 338.
34

c. Example c)
The surveyors stated example c) as follows:

The resident was documented as having fever greater than 101
degrees on 05-Nov-95 (102.2 Ax and 101.9), 08-Nov-95 (101.5
Ax) and 09-Nov-95 (101.5 Ax). The resident was given Tylenol
which was ordered PRN for fever. There is no documentation of
physician notification for any of the four (4) documented
temperature elevations which potentially could lead to resident harm
and/or deterioration.

HCFA Ex. 5, at 10.

As with the other allegations, this allegation rests on the premise that Petitioner
was obligated, under professionally recognized standards of care, to notify Dr.
deLeon of every instance when a resident’s temperature exceeded 101 degrees. I
have discussed this premise under Finding 2. It is not necessary for me to repeat
my discussion here, except to say that I do not find that the preponderance of the
evidence substantiates the premise. The standard of care for reporting
temperatures does not require a facility automatically to report to a resident’s
physician every temperature of the resident in excess of 101 degrees. Rather, the
standard is that a temperature change should be reported when it evidences a
significant deterioration in the resident’s condition.

Petitioner complied with the applicable standard of care in the treatment that it
provided to Resident 5 between November 5 and November 9, 1995. There was
no need for the staff to have notified Dr. deLeon of fluctuations in the resident’s
temperature, inasmuch as the fluctuations were evidence of an underlying
condition of which Dr. deLeon and Petitioner’s staff were aware. P. Ex. 10, at
2. None of the temperatures recorded during the period from November 5
through November 9 suggested a significant deterioration in the resident’s
condition. See P. Ex. 10, at 2.

Although the surveyors did not allege specifically that Petitioner’s staff failed to
monitor or to treat adequately the resident’s fever, I have examined the record of
care provided to the resident in order to decide whether the staff complied with
applicable standards of care which govern monitoring and treatment. Petitioner’s
staff monitored the resident’s fever, and treated it appropriately. The care that
was provided to the resident at this time is consistent with the resident’s family’s
35

request that the resident be given comfort measures only. P. Ex. 8, at 8; Tr. at
347 - 349. It is the treatment that Dr. deLeon ordered be given to Resident 5.
See P. Ex. 10, at 2.

Resident 5 was readmitted to Petitioner’s facility from Vencor Hospital on
November 3, 1995. P. Ex. 8, at 8. The Vencor Hospital discharge summary
recited that:

The patient’s son has requested no further antibiotic therapy [for the
resident] or further intervention other than treatment for comfort
measures only. The patient remains a full no-code.

Id.

I infer from this discharge summary that Petitioner’s staff and Dr. deLeon knew
as of November 3, 1995, that the care instructions for Resident 5 included a
request that no further antibiotic therapy be given to the resident and that the
resident was to be provided with comfort measures only. The care that Petitioner
provided to the resident between November 5 and November 9, 1995 must be
evaluated, not only in light of professionally recognized standards of care, but in
light of these instructions. :

The May 22, 1996 notice of results of informal dispute resolution which the
Florida State survey agency sent to Petitioner suggests that Petitioner could have
conditioned the care it provided to Resident 5 after November 3, 1995 on the
instructions given by the resident’s son, only in the presence of a living will
signed by the resident, or a legal power of attorney. HCFA Ex. 12, at 2.

HCFA has not offered any authority for this assertion. In fact, it is not clear that
HCFA is arguing this assertion now. In any event, the preponderance of the
evidence is that it is an acceptable standard of practice for a nursing home to
predicate the care it gives to a resident on the instructions contained in a hospital
discharge summary. Tr. at 343 - 346.

The evidence establishes that Petitioner’s staff treated the resident consistent with
the instructions contained in the Vencor Hospital discharge summary. There is
no evidence that resident was either harmed or suffered the potential for harm
from this care. HCFA has not offered any evidence to show that the resident
was harmed or even potentially harmed by the care given to her. The staff
monitored the resident’s temperature frequently between November 5 and
November 9, 1995. P. Ex. 8, at 18 - 22. The resident’s temperature fluctuated
36

during this period:: During this entire period, the nursing staff was attentive to
the resident’s needs, administering Tylenol elixir and ice packs to the resident,
when necessary, to control the resident’s fever. Id. Administration of these

measures had the effect of reducing the resident’s fever. Id.; Tr. at 270 - 272.

d. Example d)
The surveyors stated example d) as follows:

The resident was documented as having a fever in excess of 101
degrees (x5) from 12-Nov-95 through 14-Nov-95 . . . . [examples
omitted]. The resident was given Tylenol which was ordered PRN
for fever. There is no documentation that the facility monitored the
resident’s potentially harmful fever between | AM on 13-Nov-95
and 3:30 AM on 14-Nov-95. The resident maintained a fever in
excess of 101 degrees for 35.5 hours and the physician was not
notified until the resident’s fever reached 104 degrees axillary at
3:30 AM on 14-Nov-95. The resident experienced harm and
deterioration of physical well-being which resulted in admission to
the hospital ordered by the physician at 3:45 AM on 14-Nov-95.

HCFA Ex. 5, at 10- 11.

This example contains several allegations. First, the surveyors allege that were
five instances between November 12 and November 14, 1995 in which Resident
5 was documented as having a fever in excess of 101 degrees. Implicit in this
allegation is the conclusion that Dr. deLeon ought to have been informed of each
of these fevers in excess of 101 degrees. Second, the surveyors allege that
Petitioner failed to monitor the resident’s fever for approximately 26 hours,
between 1:00 am on November 13 and 3:30 am on November 14. Third, the
surveyors allege a continuous period of more than 35 hours in which the resident
maintained a fever in excess of 101 degrees. Finally, the surveyors suggest that
dereliction of care by Petitioner’s staff resulted in harm to the resident.

I find these allegations to be without merit. They are inaccurate in several key
respects. As with the allegations in the examples a) through c), they depend on
an asserted standard of care that a facility must notify a resident’s physician each
time the resident’s temperature exceeds 101 degrees which I find not to be the
applicable standard of care.
37

A close examination of the record of care provided by Petitioner to Resident 5
between November 12 and 14, 1995, shows that Petitioner’s staff continued to
provide care to the resident which was consistent with applicable. standards of
care and with the care that had been ordered for the resident. I do not find that
Petitioner was derelict in the care it provided, nor do I find evidence that
Petitioner’s care caused harm to the resident.

The record establishes that, between November 12 and November 14, 1995,
Resident 5 continued to manifest a fever that Petitioner’s staff sought to control
with the administration of Tylenol, ice packs, and cool towels. P. Ex. 8, at 23;
33. The record shows that the resident’s fever was not continuous. There is no
35 hour period between November 12 and November 14 in which the resident
ran a fever in excess of 101 degrees. Id, at 23 - 24. To the contrary,
Petitioner’s staff was successful in its efforts to reduce the fever, using the
methods I have described. Id. At several points between November 12 and
November 14, the resident’s fever was reduced below 100 degrees. Id.

The surveyors also are incorrect in their assertion that the resident’s fever went
unmonitored for a period of about 26 hours between November 13 and
November 14. It is true that the nursing notes for the resident do not record
temperature readings continuously for this period. See P. Ex. 8, at 23. But,
elsewhere in the resident’s record, is a report of the administration of Tylenol to
the resident and the effect of that medication on the resident’s fever. It records
several temperature readings of the resident on November 13, and at 6:00 am on
November 14. Id. at 33. It shows also that the administration of Tylenol to the
resident, coupled with the other treatments that Petitioner’s staff administered to
the resident, were effective in controlling the resident’s fever.

The fever of 104 degrees that Resident 5 manifested on November 14, 1995, at
about 3:30 am, constitutes a departure from the pattern of temperatures which the
resident had manifested for the previous two days. The highest recorded
temperature for the previous two days was 101.8 degrees (by axillary method) on
November 13. The nursing staff's immediate response to the resident’s
temperature increase on November 14 was to call Dr. deLeon, who promptly
ordered the resident transferred to a hospital. Id. at 23. I find the nursing staff's
decision to contact Dr. deLeon when the resident’s temperature rose to 104
degrees to be consistent with what is required by the applicable standard of care.
Here, the nursing staff concluded that the resident’s condition was deteriorating,
based at least in part on the spike in the resident’s temperature, and called Dr.
deLeon.
38

By contrast, the temperature increases which occurred on November 12 and 13
were not atypical of the resident’s general condition, and were treated
successfully by Petitioner’s staff. There was nothing that the staff did that Dr.
deLeon would have ordered be changed, had the staff contacted Dr. deLeon
earlier. P. Ex. 10, at 2.

5. Petitioner followed professionally recognized standards of care
in providing care to Resident 1.

The surveyors who conducted the November 1995 survey of Petitioner reviewed
the records of a stays at Petitioner’s facility by Resident 1. The record of this
stay is documented in P. Ex. 9 and P. Ex. 12.

Resident | was admitted to Petitioner’s facility suffering from decubitus ulcers.
P. Ex. 9, at | - 3. The record of the resident’s treatment establishes that at least
one of these ulcers became infected. Dr. deLeon was notified by Petitioner’s
staff of the infection, and he directed care for the resident consisting of
laboratory tests and the administration of antibiotics to the resident. P. Ex. 9, at
7. By November 7, 1995, the resident was receiving antibiotic therapy. Id.; P.
Ex. 10, at 2 - 3. Dr. deLeon discussed this therapy with Petitioner’s staff on
that date. Id,

The surveyors stated their allegation concerning Petitioner’s treatment of Resident
1 as follows:

Resident # 1 was documented as having a fever of 103.8 axillary at
2:30 AM on 08-Nov-95. The resident was given Tylenol, which
was ordered PRN for fever, and cool wet towels were applied.
There is no documentation that the physician was notified of this
change in the resident’s condition.

HCFA Ex. 5, at 11. As I read this allegation, it consists entirely of an assertion
that Petitioner failed to discharge an asserted duty to notify Dr. deLeon of the
resident’s fever. There is no allegation that Petitioner failed to monitor the
fever, that the treatment which Petitioner provided for the resident’s fever was
inappropriate, or that the resident was harmed, actually or potentially, by the
care that Petitioner gave to the resident. The allegation thus can be characterized
as an assertion that the failure of Petitioner to notify Dr. deLeon of the resident’s
temperature is, in and of itself, and without regard to the circumstances, a failure
to comply with professionally recognized standards of care.
39

In this instance, it was not necessary for Petitioner’s staff to notify Dr. deLeon of
the resident’s temperature. As I have held above, there is no standard of care
which would require a facility automatically to notify a resident’s treating
physician of a resident’s fever. Thus, I cannot conclude that Petitioner is per se
liable for not having notified Dr. deLeon of the episode of fever involving
Resident |.

Moreover, it is evident from the context of the care that Petitioner gave to
Resident | that a fever was an expected development which did not signify a
deterioration in the resident’s condition requiring notification of Dr. deLeon.
The resident was given the treatment necessary to control both the source of the
fever and the fever.

The resident was experiencing an infection. A fever was a likely consequence of
the infection. Tr. at 350 - 351. Only hours before the resident ran a fever, Dr.
deLeon initiated antibiotic therapy for the resident. P. Ex. 9, at 7; P. Ex. 10, at
2-3. To expect immediate results from the therapy would be unrealistic. In
the words of Dr. Page, it would have been “senseless” to notify Dr. deLeon of a
fever that was expected, especially in light of the care that Dr. deLeon had
prescribed for the resident. Tr. at 350 - 351.

The fever experienced by Resident | was an isolated episode which Petitioner’s
staff controlled quickly and efficiently. The staff treated the fever with Tylenol
elixir and the application of cool wet towels to the resident. P. Ex. 9, at 8.
Within hours, the resident’s fever was reduced, and it remained that way. Id.

6. Petitioner complied substantially with the requirements of 42
C.F.R. § 483.25 between November 21, 1995 and December 19,
1995.

The preponderance of the evidence is that, between November 21, 1995 and
December 19, 1995, Petitioner complied substantially with the requirements of
42 C.F.R. § 483.25. The evidence establishes Petitioner to have been out of
compliance with the requirements of the regulation on one date, September 24,
1995. However, the evidence of noncompliance relates only to an isolated event,
and not to the care that Petitioner gave to its residents on other dates.

As I find above, at Finding 2, 42 C.F.R. § 483.25 incorporates a requirement
that a long-term care facility comply with applicable standards of care in its
treatment of residents. The standards of care require a facility to notify a
40

resident’s treating: physician of a resident’s fever that evidences a significant
deterioration in the resident’s condition. And, as I find at Finding 4, on
September 24, 1995, Resident 5 experienced an increase in her temperature
which evidenced a potential deterioration in the resident’s condition. Under the
applicable standard of care, Petitioner’s staff was required to notify Dr. deLeon
of that temperature increase.

Petitioner did not comply substantially with the requirements of 42 C.F.R. §
483.25 on September 24, 1995. The failure of Petitioner to notify Dr. deLeon of
a sharp increase in the resident’s temperature on that date contravened a standard
of care that is incorporated within the regulation. That failure posed a risk of
harm to the resident’s health or safety that was more than minimal. 42 C.F.R. §
488.301.

However, I find that Petitioner complied substantially with the requirements of
42 C.F.R. § 483.25 on all other relevant dates. As I discuss above, at Findings
4 and 5, with the exception of the episode that occurred on September 24, 1995,
Petitioner complied with applicable standards of care in the care that it provided
to Residents 5 and 1.

HCFA’s assertion that Petitioner was not complying substantially with the
requirements of 42 C.F.R. § 483.25, between November 21 1995, and December
19, 1995, rests on two premises: (1) that the evidence of Petitioner’s failure to
comply with standards of care in providing care to Residents 5 and | establishes
a generalized indifference by Petitioner and its staff to the obligation to comply
with those standards; and (2) that this generalized indifference persisted until
December 19, 1995, when Petitioner was re-surveyed and found to be in
substantial compliance with participation requirements as of that date. The
preponderance of the evidence does not substantiate either of these premises.

As to HCFA’s first premise, there is no evidence of a generalized indifference by
Petitioner to the requirements of professionally recognized standards of care.

The evidence establishes only an isolated episode of Petitioner not complying
with professionally recognized standards of care in providing care to Resident 5.
Evidence relating to the other episodes relied on by HCFA shows that
Petitioner’s staff was attentive to the needs of the residents and diligent in
providing care to them. The fact that Petitioner may not have complied
substantially with the requirements of 42 C.F.R. § 483.25 in its treatment of one
resident on one isolated date does not establish even a prima facie case of a
41

generalized failure by Petitioner to comply with standards of care or with the
requirements of the regulation.

Indeed, the evidence of noncompliance by Petitioner on one date is greatly
outweighed by evidence that Petitioner complied with professionally recognized
standards of care in caring for Residents 5 and | in all of the other episodes cited
by the Florida State survey agency and relied on by HCFA. And, it is
outweighed also by evidence that there were no derelictions of care in the
treatment that Petitioner gave to any of its other residents.

As to HCFA’s second premise, HCFA has offered no specific evidence that
Petitioner failed to comply with the requirements of the regulation during the
period beginning November 21, 1995 and ending on December 19, 1995. HCFA
argues that I should infer that Petitioner was not complying on those dates from
the evidence that HCFA offered concerning Petitioner’s past practices.

I find that the sparse evidence of noncompliance prior to November 21, 1995 is
insufficient for me to infer that Petitioner was not complying with the regulation
on or after November 21. HCFA has not established a prima facie case that
Petitioner was not complying with the requirements of 42 C.F.R. § 483.25 on or
after November 21, 1995. Furthermore, there is affirmative evidence that
Petitioner complied with the requirements of 42 C.F.R. § 483.25 after November
21, 1995. The Florida State survey agency surveyor who made a follow up visit
to Petitioner on November 25 found no evidence on that date that Petitioner was
failing to comply with the requirements of 42 C.F.R. § 483.25. Tr. at 155 -
156.

7. The alleged failure by the Florida State survey agency to follow
applicable survey and remedial procedures is irrelevant to my
decision.

Petitioner argues that the Florida State survey agency’s finding that Petitioner’s
alleged deficiencies constituted immediate jeopardy to Petitioner’s residents is
vitiated by the agency’s alleged failure to follow applicable survey procedures.
HCFA asserts that I should not consider this argument, because Petitioner did not
make it in its hearing request. HCFA asserts also that, under applicable
regulations governing surveys, a failure by a State survey agency to follow
applicable survey requirements is not a basis to invalidate the results of a survey.
HCFA’s reply brief at 14 - 16; see 42 C.F.R. § 488.305.
42

It is unnecessary that I resolve these arguments. I base my decision in this case
on HCFA’s failure to make a prima facie case on elements of its allegations, and
on the preponderance of the evidence, which supports Petitioner’s affirmative
contentions of fact.

8. There is no basis for me to sustain a civil money penalty
against Petitioner in the upper range of civil money penalties for
the period beginning November 21, 1995 and ending on December
19, 1995 premised on Petitioner’s alleged failure to comply
substantially with the requirements of 42 C.F.R. § 483.25.

There are four necessary elements to HCFA’s determination to impose an upper
range civil money penalty of $7,500 per day against Petitioner for the period
from November 21, 1995 until December 19, 1995. These are that: (1)
Petitioner failed to comply substantially with the requirements of 42 C.F.R. §
483.25; (2) Petitioner’s failure to comply with the regulation was of a level of
severity that posed immediate jeopardy to Petitioner’s residents; (3) Petitioner’s
failure to comply with the regulation, at an immediate jeopardy level, persisted
from November 21, 1995 until December 19, 1995; and (4) the presence of other
deficiencies, cited at tags 272, 279, and 385 in HCFA Ex. 5, coupled with
Petitioner’s history of noncompliance with participation requirements, its
culpability, and its financial status, justified a penalty of $7500 per day.

The preponderance of the evidence is that the first of these four necessary
elements is not established. Based on that, I conclude that I may not sustain an
upper range civil money penalty against Petitioner for the period that is at issue
in this case.

There is no need for me to consider whether HCFA established a prima facie
case on the other three elements of its determination to impose an upper range
penalty against Petitioner. I may not sustain a civil money penalty against
Petitioner in the upper range of penalties (which includes a penalty of $7,500 per
day) unless I find that Petitioner failed to comply substantially with the
requirements of 42 C.F.R. § 483.25 during the period from November 21, 1995
until December 19, 1995. That is because Petitioner’s alleged failure to comply
with the regulation, at the immediate jeopardy level, is an essential predicate to
HCFA’s determination to impose an upper range penalty against Petitioner.
43

A determination by HCFA to impose a civil money penalty in the upper range
against a long-term care facility may only be sustained if either: the facility is
deficient in complying with a participation requirement at the immediate jeopardy
level of noncompliance; or, if the facility is found to have engaged in repeat
deficiencies. 42 C.F.R. § 488.438(a)(1) and (d)(2). Here, HCFA predicated its
determination to impose a civil money penalty against Petitioner in the upper
range solely on the presence of an alleged failure by Petitioner to comply with
the participation requirement contained in 42 C.F.R. § 483.25 at the immediate
jeopardy level of noncompliance. HCFA did not allege that an upper range
penalty could be based on the presence of repeat deficiencies in Petitioner’s
operations.

I have found that Petitioner complied substantially with the requirements of 42
C.F.R. § 483.25 during the period from November 21, 1995 until December 19,
1995. For that reason, I conclude that there is no basis for me to sustain an
upper range civil money penalty against Petitioner, including a penalty of $7,500
per day, for the period from November 21, 1995 until December 19, 1995.

9. There is no basis for me to sustain a civil money penalty
against Petitioner in the lower range of civil money penalties for
the period beginning November 21, 1995 and ending on December
19, 1995 premised on Petitioner’s alleged failure to comply
substantially with the requirements of 42 C.F.R. § 483.25.

I may not sustain a civil money penalty against Petitioner in the lower range of
$50 - $3,000 per day for the period beginning November 21, 1995 and ending
December 19, 1995, premised on Petitioner’s alleged failure to comply
substantially with the requirements of 42 C.F.R. § 483.25. That is because I
have concluded that, during the period at issue, Petitioner complied substantially
with the requirements of the regulation.

In reaching this decision, I am mindful of the requirements of 42 C.F.R. §
488.438(e)(1). That regulation provides that, in reviewing a determination by
HCFA to impose a civil money penalty, an administrative law judge may not set
a penalty at zero or reduce a penalty to zero. I do not read this regulation as
requiring me to sustain a penalty where there is no legal basis to impose one.
Rather, the regulation instructs me not to absolve a facility from liability for a
civil money penalty where there exists a basis to impose a penalty. I would have
sustained a civil money penalty against Petitioner, albeit at a reduced amount,
had I concluded that Petitioner was not complying substantially with the
44

requirements of 42 C.F.R. § 483.25, but that the level of noncompliance
determined by HCFA (immediate jeopardy) was clearly erroneous.

10. I am without authority to impose a civil money penalty
against Petitioner based on the allegations made at tags 272, 279,
and 385 in the report of the November 1995 survey of Petitioner.

I have no authority to decide whether a civil money penalty would be reasonable
predicated on the findings of deficiencies under tags 272, 279, and 385, absent a
decision that Petitioner was deficient under tag 309. I may only hear and decide
such issues as arise from a determination by HCFA to impose a remedy. HCFA
made no determination to impose a civil money penalty against Petitioner based
on the findings of deficiencies under tags 272, 279, and 385. The findings of
deficiency under tags 272, 279, and 385 were used by HCFA only as ancillary
evidence to justify fixing at $7,500 per day the civil money penalty that HCFA
imposed against Petitioner, premised on the alleged deficiency found under tag
309.

At the November 1995 survey, the surveyors found Petitioner to be deficient
under four participation requirements. These alleged deficiencies included the
asserted failure of Petitioner to comply substantially with the requirements of 42
C.F.R. § 483.25, cited at tag 309. HCFA Ex. 5, at 7-11. The alleged
deficiency under tag 309 was the basis for HCFA’s determination to impose a
civil money penalty against Petitioner. I have discussed the evidence relating to
this alleged deficiency in detail above, at Findings 3 - 5.

The other deficiencies cited by the surveyors are contained at tags 272, 279, and
385 of the November 1995 survey report. HCFA Ex. 5, at 2 - 7; 12 - 13.
These alleged additional deficiencies were relied on by HCFA as a basis for
determining that a civil money penalty of $7,500 per day should be imposed
against Petitioner. However, the necessary predicate for HCFA’s determination
was that the alleged deficiency under tag 309 be at the immediate jeopardy level.
HCFA could not have imposed an upper range penalty against Petitioner, absent
a finding of repeat deficiencies, unless it made a determination that there was a
deficiency at the immediate jeopardy level. 42 C.F.R. § 488.438(a)(1). Once
HCFA made the immediate jeopardy determination, predicated on the alleged
deficiency cited at tag 309, then HCFA considered the other alleged deficiencies
cited at tags 272, 279, and 385 as ancillary evidence to support a penalty within
the upper range of $7,500 per day. HCFA’s posthearing brief at 41 - 42; See 42
C.F.R. §§ 488.438(f); 488.404.
45

What HCFA did not do was to make a determination whether any or all the
deficiencies cited at tags 272, 279, and 385 merited the imposition of a civil
money penalty against Petitioner, absent the deficiency cited at tag 309. The
scope and severity of the deficiencies cited at tags 272, 279, and 385 were at the
non-immediate jeopardy level (although HCFA now asserts that it erred in
determining the deficiency at tag 385 to be of less than an immediate jeopardy
level of severity). Presumably, HCFA might have determined to impose a civil
money penalty against Petitioner in the lower range of penalties from $50 -
$3,000 per day based on the alleged presence of the deficiencies cited at tags
272, 279, and 385. See 42 C.F.R. § 488.408(d). But, HCFA did not make
such a determination.

I have no authority to decide whether a civil money penalty might be merited for
Petitioner’s alleged failure to comply with the requirements cited under tags 272,
279, and 385. My authority to hear and decide a case involving HCFA derives
only from a determination by HCFA to impose a remedy. See 42 C.F.R. §
498.3. I have no authority to hear and decide an issue concerning which HCFA
has not made a determination. Rafael Convalescent Hospital. I make no finding
concerning whether HCFA established a prima facie case of deficiency under
tags 272, 279, and 385, or whether Petitioner, by a preponderance of the
evidence, overcame any prima facie case that HCFA might have made. The
parties presented evidence and argument concerning these alleged deficiencies.
However, that evidence and argument were not presented to support or rebut a
determination by HCFA to impose a remedy based on these alleged deficiencies.
Rather, they were presented in the context of HCFA’s reliance on the alleged
deficiencies cited under tags 272, 279, and 385 as ancillary evidence to support
its determination to impose a civil money penalty against Petitioner predicated on
the deficiency alleged under tag 309. The fact that the parties presented evidence
concerning the deficiencies alleged under tags 272, 279, and 385 is, therefore, no
basis for me to make findings concerning the alleged deficiencies.

It is tempting to decide whether the alleged deficiencies existed in light of the
evidence offered by the parties. However, any decision that I might issue
concerning the deficiencies found under tags 272, 279, and 385 would be dicta of
no legal effect, inasmuch is there is no determination to impose a remedy based
on these deficiencies.
46

I make no finding-whether HCFA has the authority to make a new determination
to impose a remedy against Petitioner predicated on the deficiencies that were
found under tags 272, 279, and 385, but not on the deficiency that was found
under tag 309. The issue of whether HCFA could do so would not be
appropriate for a hearing and decision until and unless HCFA makes an
additional determination. If Petitioner requested a hearing from that
determination, then, presumably, the issue of HCFA’s authority to make a new
determination could be heard and decided in the context of that hearing.

/s/

Steven T. Kessel
Administrative Law Judge