Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

In the Case of: )
)
Martha & Mary Lutheran Services, ) Date: May 10, 2007

(CCN: 50-5474), )
)
Petitioner, )

) Docket No. C-06-575

-v.- ) Decision No. CR1595
)
Centers for Medicare & Medicaid )
Services. )
)

DECISION

I sustain the determination of the Centers for Medicare & Medicaid Services (CMS) that
Petitioner failed to comply with a Medicare participation requirement provided care that
was at a substandard level. As a consequence Petitioner loses its authority to conduct a
nurse aide competency and evaluation program (NATCEP) for a period of two years.

I. Background

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

Petitioner was surveyed for compliance with Medicare participation requirements twice in
May 2006. The first survey was an unannounced survey conducted by employees of the
Washington State Department of Social and Health Services (DSHS) on May 2 and 4,
2006. At that survey the surveyors found that Petitioner provided care of a substandard
quality. They then conducted a partial extended survey of Petitioner on May 15, 2006.
Ultimately, the surveyors concluded that Petitioner failed to comply with two
2

participation requirements at a level of noncompliance that was substandard. CMS
concurred with the surveyors’ findings. The consequence of CMS’s determination was
that Petitioner lost its authority to conduct NATCEP for two years. CMS imposed no
additional remedies.

Petitioner requested a hearing and the case was assigned to me for a hearing and a
decision. The parties completed a pre-hearing exchange which included an exchange of
proposed exhibits. I scheduled an in-person hearing in the case. However, the parties
then agreed that the case could be heard and decided after a hearing by telephone. I
conducted a hearing by telephone on March 8, 2007. I received into evidence exhibits
from CMS which are identified as CMS Ex. 1-CMS Ex. 72, and exhibits from Petitioner
which are identified as P. Ex. 1-P. Ex. 51.

IL. Issue, findings of fact and conclusions of law
A. Issue

The issue in this case is whether, as of May 2006, Petitioner manifested one or more
deficiencies at a level of care that was substandard.

B. Findings of fact and conclusions of law

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

At the outset I note that CMS alleges that, as of May 2006, Petitioner failed to comply
substantially with two Medicare participation requirements at a substandard level of care.
The deficiencies alleged by CMS are two distinct failures by Petitioner to comply with the
requirements of 42 C.F.R. § 483.13(c). The regulation requires a facility to develop and
implement policies and procedures that prohibit mistreatment, neglect, and abuse of
residents and misappropriation of residents’ property. First, CMS alleges that Petitioner
failed to protect vulnerable residents residing in a secured dementia unit from aggressive
physical, verbal, and mental abuse by a resident who Petitioner’s staff knew or should
have known was capable of aggressive and dangerous behavior. Second, CMS alleges
that Petitioner failed to comply with its regulatory obligation to investigate incidents of
abusive resident-on-resident behavior and to report them to the appropriate State
authorities.
3

In this decision I address only the first of these two allegations of noncompliance. I find
it unnecessary to address the second allegation because Petitioner clearly failed to protect
its residents against abuse or neglect and because Petitioner did not disprove CMS’s
determination that the level of protection that Petitioner gave to its residents was
substandard. That is sufficient for me to sustain Petitioner’s loss of NATCEP because, as
a matter of law, a facility that is found to provide a substandard quality of care is
prohibited from conducting NATCEP. Act, section 1819(f)(2)(B)(iii) (citing section
1819(g)(2)(B)(i).

1. Petitioner failed to comply with the requirements of 42 C.F.R.
§ 483.13(c) because it failed to protect its residents adequately against a
verbally and physically aggressive resident.

The purpose of 42 C.F.R. § 483.13(c) is to assure that a skilled nursing facility protect its
residents against mistreatment, abuse, and neglect. “Abuse” is defined at 42 C.F.R.

§ 488.301 to mean: “the willful infliction of injury, unreasonable confinement,
intimidation, or punishment with resulting physical harm, pain or mental anguish.”
“Neglect” is defined by the same regulation to mean: “failure to provide goods and
services necessary to avoid physical harm, mental anguish, or mental illness.” The
definitions of these terms make it evident that the regulation is not only intended to
protect residents against the willful infliction of harm but also against harm that is the
consequence of indifference and or negligence. Harm resulting from poor planning to
deal with exigent circumstances and from failure to supervise residents appropriately falls
within the meaning of neglect.

In this respect the reach of 42 C.F.R. § 483.13(c) is very similar to that of another
regulation, 42 C.F.R. § 483.25(h)(2). The latter regulation requires a facility to provide
each of its residents with adequate supervision and assistance devices to prevent
accidents. The regulation has been interpreted to require a facility to implement all
reasonable efforts to protect residents against adverse events that are reasonably
foreseeable. A practically identical duty is prescribed by 42 C.F.R. § 483.13(c). Failure
by a facility to protect a resident against a known or foreseeable hazard — including the
possibility that a resident might be physically abused or assaulted by another resident
whose aggressive behavior has become known to a facility’s staff — is a failure by a
facility to provide services that are necessary to prevent physical harm or mental anguish
and is, thus, neglect.
4

Here, CMS presented evidence that Petitioner failed to fulfill its obligation to protect
several demented residents against the abusive and assaultive acts committed by a
resident who is identified by CMS as Resident # 1. The evidence is strong prima facie
proof, which I find that Petitioner did not rebut, that Petitioner neglected the needs of its
residents in contravention of 42 C.F.R. § 483.13(c).

The evidence offered by CMS shows that, over a period of about six weeks, Resident # 1
engaged in a series of abuses and physical assaults directed against residents in
Petitioner’s secured dementia unit. Although Petitioner’s staff was aware of the
resident’s propensities, their efforts to protect residents against Resident # 1’s behavior
were ineffective. His abusive and assaultive behavior continued, essentially unchecked,
culminating with an incident in which he pushed another resident, causing her to fall and
to break her wrist.

Resident # 1’s abusive and assaultive behavior played out with a series of incidents, all of
which were known to Petitioner’s staff. On March 9, 2006, Resident # 1 put his hand
around the head of a resident who is identified as Resident # 2, and covered her mouth,
causing the victim of this behavior to scream for help. CMS Ex. 25, at 1. On March 15,
2006, Resident # 1 again assaulted Resident # 2, slapping her. CMS Ex. 27. On March
24, 2006, Resident # 1 blocked the path of Resident # 3, yelled at her, and waved a
newspaper at her. CMS Ex. 29, at 1. Later on that same day, in separate incidents,
Resident # 1 kicked Resident # 4 and pulled on the wheelchair of Resident # 5. CMS Ex.
31, at 1; CMS Ex. 33, at 1.

Resident # 1’s behavior became progressively more violent. On April 2, 2006, he struck
Resident # 6 after she resisted his attempts to “get fresh,” causing the resident to sustain a
bruise to her forehead. CMS Ex. 37, at 1. On April 12, 2006, he slapped Resident # 7.
CMS Ex. 39, at 1. On April 13, 2006, Resident # 1 seized Resident # 8 by the wrists.
CMS Ex. 70, at 1. And, on April 22 he pushed Resident # 9, causing her to break her
wrist. CMS Ex. 37, at 1-5.

The evidence offered by CMS describes a pattern of mounting abuse and violence by
Resident # 1 directed at other residents. I agree with CMS that Petitioner’s staff was put
on notice by these behaviors that Resident # 1 was dangerously out of control and that
other residents needed to be protected from him by all reasonable means. | infer from the
unchecked violence that Resident # 1 directed at other residents over a period of more
than a month that Petitioner’s staff failed to do what was reasonable and necessary.
5

Petitioner’s response to CMS’s allegations is to argue that it not only recognized Resident
# 1’s propensities, but that it took numerous actions that were designed to address them.
Petitioner argues that it properly identified the risks posed by Resident # 1, developed
implementation strategies to address those risks, monitored the resident, and reassessed
interventions when those that were implemented proved to be unsuccessful. At bottom,
Petitioner’s argument is that its efforts should not be judged by the behaviors manifested
by Resident # 1, but by the staff’s recognition of those behaviors and its attempts to
address them. It contends that it should not be held accountable for its failure to protect
other residents from Resident # 1 because it took all steps that it reasonably could have
taken to protect them.

I find Petitioner’s arguments to be unpersuasive. I have no doubt from the evidence that
Petitioner introduced that its staff recognized Resident # 1 to be a threat to other
residents. It is apparent, also, from that evidence, that Petitioner’s staff made efforts to
address the resident’s behavior and to protect other residents from him. But, these efforts
were inadequate. Resident # 1’s unchecked abusive and violent behavior, particularly
after April 1, 2006, put the staff on notice that all of the preventive measures that they
had implemented to protect residents from Resident # 1 were failing. Given that,
Petitioner’s staff owed the other residents a duty of taking additional necessary measures
— including segregating Resident # 1 from the remainder of the resident population, or
discharging the resident — in order to protect them.' The actions taken by the staff were
simply inadequate given the dangers to other residents posed by Resident # 1.

The actions taken in March and April 2006 by Petitioner’s staff included:

+ informing the resident’s physician on numerous occasions of the resident’s
behavioral problems and care. P. Ex. 21, at 2, 4, 5, 6, 7, 8, 11, 13, 15, 16;

+ referring the resident to a mental health provider and implementing that
provider’s recommendations. P. Ex. 21, at 7; P. Ex. 28, at 1; P. Ex. 10, at 16;

' Petitioner discharged Resident # 1 on April 23, 2006, after the resident had
committed the assaults that I describe in this decision.
6

+ referring the resident to a local hospital more than once for consultation,
consulting with a nurse practitioner, and implementing recommendations for
adjustment of the resident’s medications. P. Ex. 27, at 1; P. Ex. 31, at 1; P. Ex. 32,
at 1; P. Ex. 25, at 1; P. Ex. 21, at 9; P. Ex. 10, at 1, 7 - 8; and

* implementing increased monitoring of the resident.

Petitioner asserts that the monitoring that it implemented during March and April 2006
was “near[ly] constant.” P. Ex. 49, at 2. It contends that the monitoring was generally
one-on-one or line-of-sight. P. Ex. 48, at 2; P. Ex. 49, at 3.

But, obviously, the psychiatric interventions, the medication adjustments, and the
enhanced monitoring were inadequate to protect other residents from Resident # 1’s
violent outbursts. Petitioner’s staff should have recognized that their efforts simply were
inadequate to protect other residents and, well before the incident of April 22, 2006, the
staff should have done whatever was necessary to keep Resident # 1 apart from those
vulnerable residents. The undisputed evidence in this case is that, after April 1, 2006,
Resident # 1 assaulted other residents physically four times within a three-week period.
That level of violence is simply intolerable in a facility, such as Petitioner’s facility, that
houses elderly, frail, demented, and essentially helpless individuals living together in
close proximity with each other.

2. Petitioner did not disprove CMS’s determination that the care that
Petitioner gave to its residents was of a substandard quality.

A substandard quality of care deficiency will consist of a failure by a facility to comply
with the requirements of 42 C.F.R. § 483.13 at a level of noncompliance that either poses
immediate jeopardy for a facility’s residents or which constitutes a pattern of actual harm
to residents. Here, CMS determined that the compliance that I discuss at Finding 1
constituted a pattern of actual harm but not immediate jeopardy. CMS Ex. 8, at 1. I must
sustain that finding unless Petitioner proves that it is incorrect.

Petitioner failed to do so. It argued that its care of its residents did not consist of failure
to implement its anti-abuse and neglect policies. I found that argument to be
unpersuasive at Finding 1. But, it did not argue, nor did it offer evidence to support a
contention that, if it was deficient, its noncompliance was at a scope and severity that is
less than that which CMS determined to exist. Consequently, I must sustain CMS’s
determination of scope and severity.
7

Although CMS has no additional burden to prove scope and severity beyond establishing
the presence of a deficiency, I conclude that the evidence offered by CMS in this case
strongly supports a finding of a pattern of actual harm. Resident # 1 repeatedly assaulted
other residents and some of those assaults caused injuries. The evidence offered by CMS
made it plain that the efforts of Petitioner’s staff to protect other residents from Resident
# 1 were ineffective and that the resident was a menace to other residents so long as he
resided in Petitioner’s facility and was not physically separated from the resident
population.

/s/

Steven T. Kessel
Administrative Law Judge


Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

In the Case of: )
)
Lakeside Hospital of Bastrop, ) Date: May 10, 2007

(CCN 67-0011) )
)
Petitioner, )
)

-v.- ) Docket No. C-06-677

) Decision No. CR1594
Centers for Medicare & Medicaid )
Services. )
)

DECISION

I sustain the determination of the Centers for Medicare & Medicaid Services (CMS) to
certify Petitioner, Lakeside Hospital of Bastrop, as a participating provider in the
Medicare program, effective March 29, 2006.

I. Background

Petitioner is a hospital located in Bastrop, Texas. CMS certified Petitioner to participate
in the Medicare program effective March 29, 2006. Petitioner filed a request for a
hearing, asserting that the effective certification date is incorrect and that CMS should
have certified it to participate effective February 17, 2006.' The case was assigned to me
for a hearing and a decision. The parties then agreed that the case could be heard based
on their written submissions. CMS submitted a brief along with 10 proposed exhibits
(Exs.) consisting of CMS Exs. | - CMS Exs. 10, and a reply brief. Petitioner submitted a

'Tn its request for hearing Petitioner stated that it requested that its certification be
made “effective as of February 20, 2006.” However, in its other submissions including
its brief Petitioner asserted that the certification date should be February 17, 2006. I
accept February 17, 2006 as the date that Petitioner contends should have been its
certification date.
2

brief along with three proposed exhibits consisting of P. Exs. 1 - P. Exs. 3, and a reply
brief. Petitioner also submitted an excerpt from the Federal Register as an attachment to
its brief. I receive into evidence CMS Exs. 1 - CMS Exs. 10 and P. Exs. | - P. Exs. 3.

IL. Issues, findings of fact and conclusions of law
A. Issue

The issue in this case is whether Petitioner is entitled to a Medicare certification date that
is earlier than March 29, 2006, the date when CMS determined to certify it as a
participating Medicare provider.

B. Findings of fact and conclusions of law

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

1. Petitioner did not prove that it qualified to participate in Medicare on a
date that is earlier than March 29, 2006.

The effective date of participation by a provider in the Medicare program is governed by
federal regulations at 42 C.F.R. § 489.13. Generally, a provider applying to participate in
Medicare will be certified as of the date of a survey in which the provider is found to
satisfy all applicable federal requirements. 42 C.F.R. § 489.13(b). Alternatively, a
provider that is accredited by a national accrediting organization whose program had
CMS approval at the time of the decision to accredit it may be deemed by CMS to satisfy
participation requirements based on that accreditation. 42 C.F.R. § 489.13(d)(1). In that
instance, and assuming that the provider is not subject to additional participation
requirements, the provider will be certified to participate on the date of that provider’s
initial request for participation. 42 C.F.R. § 489.13(d)(1)Gi).

In practice the regulation imposes three duties on a provider seeking to be certified based
on an accreditation by an approved organization. First, the provider must establish that it
is accredited. Second, the provider must prove that it either meets or is not subject to
other certification requirements. Third, the provider must submit an acceptable
application for participation.
3

Petitioner sought certification based on its accreditation as a hospital by the Joint
Commission on Accreditation of Healthcare Organizations (JCAHO). I find that it
attained the necessary accreditation effective February 17, 2006. There was some
confusion about this date because JCAHO issued two letters concerning Petitioner’s
accreditation, each establishing a different accreditation date. On March 29, 2006,
JCAHO sent a letter to Petitioner telling it that it was accredited as of that date. CMS Ex.
1, at 1. However, on June 23, 2006, JCAHO sent a second letter to Petitioner telling it
that its effective accreditation date was February 17, 2006. CMS Ex. 9, at |. It appears
from the correspondence that the actual date of the JCAHO accreditation was February
17, 2006 because that was the date of the JCAHO survey at which Petitioner was found to
satisfy accreditation requirements.

However, and as I discuss above, accreditation is not the only criterion for certification.
Certification depends on three criteria, including a successful survey outcome or
accreditation, satisfying CMS that other requirements are satisfied to the extent that they
apply, and filing an acceptable application for certification. Here, Petitioner satisfied the
first criterion — accreditation — effective February 17, 2006. CMS does not contend that
there were additional requirements that Petitioner, a general hospital, needed to satisfy.”
That leaves only the question as to when Petitioner filed an acceptable application for
certification.

I conclude that Petitioner filed its application in April 2006, after the date that CMS
determined to certify it. Petitioner argues that, in fact, it filed its application “a week or
so after the . . . [JCAHO] survey.” Petitioner’s brief at 2. According to Petitioner, it had
the application hand-delivered to a fiscal intermediary that was charged with processing
and approving provider enrollment applications for hospitals in Texas. “Unfortunately,”
contends Petitioner, “the application did not reach the proper department at . . . [the fiscal
intermediary] and was never logged in as received.” Petitioner contends that it filed a
second application in April only after it learned that the first one had been lost. Jd.

However, Petitioner produced no persuasive evidence to support its contention that it
filed an application in February. It did not produce, for example, a copy of the alleged
February application nor did it produce any document verifying that the fiscal
intermediary received it. Absent such proof I am unpersuaded that Petitioner filed an
application in or about February 2006 as it contends.

? There are, for example, distinct certification requirements for a psychiatric
hospital as opposed to a general hospital.
4

Furthermore, the contents of the allegedly lost application are unknown inasmuch as
Petitioner did not produce a copy of it. Consequently, it is impossible to say whether the
application was complete and contained the information CMS needed in order to process
Petitioner’s application.’

Thus, Petitioner did not satisfy a// of the regulatory criteria for certification at any time
prior to April 2006 when it filed its second application. CMS’s determination to certify
Petitioner effective March 29, 2006, gave Petitioner the earliest certification date that it
was entitled to consistent with the requirements of 42 C.F.R. § 489.13.

2. Ido not have the authority to order CMS to certify Petitioner
retroactively to participate in Medicare as of February 17, 2006.

There are circumstances where CMS may certify a provider retroactively to participate in
Medicare. Pursuant to 42 C.F.R. § 489.13(d)(2):

Ifa provider . . . meets . . . [all regulatory requirements for certification] the
effective date may be retroactive for up to one year to encompass dates on
which the provider . . . furnished, to a Medicare beneficiary, covered
services for which it has not been paid.

The regulation confers discretion on CMS. CMS “may,” not “must,” certify a provider
retroactively under defined circumstances. No provider is entitled to retroactive
certification. And, I am without authority to order CMS to take an action that is entirely
within its discretion to take or not to take.

3 CMS argues that it is not obligated to certify a provider for participation until the
date when it completes its review of a provider’s application. In other words, a provider
is not entitled to participate, assuming it meets regulatory criteria for participation, as of
the date that it files its application but only as of the date that CMS finishes its processing
of the application. It is unnecessary that I decide this argument because ultimately CMS
determined to certify Petitioner on a date that was prior to the date that it filed its
completed application. As I discuss below, at Finding 2, CMS has discretion, in certain
circumstances, to certify a provider retroactively to a date that is earlier than the date
when the provider files its application for participation.
5

Petitioner contends that CMS should have certified it retroactively to February 17, 2006,

the date when it was accredited by JCAHO. Essentially, its premise is that it satisfied all

certification criteria as of that date. Therefore, according to Petitioner, it would be unfair
not to certify it retroactively. I am without authority to order CMS to do what Petitioner

demands because certifying Petitioner retroactively is an act of discretion that is entirely

within CMS’s province.

Moreover, as I discuss above, at Finding 1 Petitioner did not in fact satisfy all
certification criteria as of February 17, because it did not prove that it submitted an
acceptable application on that date. CMS was under no legal obligation to certify
Petitioner prior to April 2006 when Petitioner submitted an acceptable application. The
fact that CMS exercised its discretion to certify Petitioner effective March 29, 2006,
confers no additional rights on Petitioner.

/s/

Steven T. Kessel
Administrative Law Judge


Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

In the Case of: )
)
Kimberly Mazzeo, ) Date: April 27, 2007

)
Petitioner, )
)

-Ve- ») Docket No. C-06-631

) Decision No. CR1591
The Inspector General. )
)

DECISION

This matter is before me on the Inspector General’s (I.G.’s) Motion for Summary
Affirmance of the I.G.’s determination to exclude the Petitioner pro se herein, Kimberly
Mazzeo, from participation in Medicare, Medicaid, and all other federal health care
programs for a period of five years. The I.G.’s Motion and determination to exclude
Petitioner are based on the terms of section 1128(a)(4) of the Social Security Act (Act),
42 U.S.C. § 1320a-7(a)(4). The record before me reveals a proper basis for exclusion and
for the imposition of the minimum five-year period of exclusion. Accordingly, | GRANT
the I.G.’s Motion.

I. Procedural Background

In 2000, Kimberly Mazzeo, Petitioner pro se, was a registered nurse licensed to practice
in the State of Florida. In September 2000, she twice violated FLA. STAT.

§ 893.13(7)(a)(9) by assuming a false name in a scheme to obtain the controlled
substances hydrocodone and oxycodone. Felony charges were filed against her in two
separate criminal proceedings in the Circuit Court for Osceola County, Florida.
Appearing with counsel, she pleaded guilty to the first felony charge and was sentenced
on November 2, 2000. Again appearing with counsel, she pleaded guilty to the second
charge and was sentenced on January 5, 2001.
2

In the fullness of time, the I.G. began the process of excluding Petitioner from
participation in Medicare, Medicaid, and all other federal health care programs. Section
1128(a)(4) of the Act dictates the mandatory exclusion, for a period of not less than five
years, of “[a]ny individual or entity that has been convicted . . . under Federal or State
law, of a criminal offense consisting of a felony relating to the unlawful manufacture,
distribution, prescription, or dispensing of a controlled substance.” Act, section
1128(c)(3)(B); 42 U.S.C. § 1320a-7(c)(3)(B). On June 30, 2006, fully five-and-one-half
years after Petitioner’s second conviction, the I.G. notified Petitioner that she was to be
excluded for the mandatory minimum period of five years.

Acting pro se, Petitioner timely sought review of the I.G.’s action in her letter of August
6, 2006. I held a prehearing conference by telephone on October 18, 2006, in order to
discuss the issues in the case and procedures for addressing those issues. The parties
agreed that the case could be decided on written submissions, and I established a schedule
for filing documents and briefs. The results of that conference appear in the Order of
October 20, 2006.

The I. G. timely filed a Motion for Summary A ffirmance and a Brief in Support of the
Motion on November 21, 2006. After being granted two extensions of time to do so,
Petitioner pro se has filed no Answer Brief. Her only submission has been a group of
four exhibits filed February 12, 2007.

The I.G. has neither filed a Reply Brief nor given notice that one would not be filed.

For purposes of 42 C.F.R. § 1005.20(c), the record in this case closed on March 6, 2007,
the date by which Petitioner was required to file her Response Brief, or to give notice that
she did not intend to do so, under the terms of the second extension of time granted her on
January 12, 2007.

The L.G. proffered I.G. Exhibits 1-10 (1.G. Exs. 1-10), and, in the absence of objection,
they are admitted. Petitioner’s four exhibits are incorrectly marked, but because they
constitute her only answer to the I.G.’s Brief, I have simply remarked Petitioner’s four
proffered exhibits as Petitioner’s Exhibits 1-4 (P. Exs. 1-4), and have admitted them as so
designated.
II. Issues

The legal issues before me are strictly limited to those noted at 42 C.F.R.
§ 1001.2007(a)(1). In the context of this record they are:

1. Whether the I.G. has a basis for excluding Petitioner from participating
in Medicare, Medicaid, and all other federal health care programs pursuant
to section 1128(a)(4) of the Act; and

2. Whether the five-year period of the exclusion is unreasonable.

I must resolve both issues in favor of the I.G.’s position. The I.G. has a basis for
Petitioner’s exclusion pursuant to section 1128(a)(4) of the Act. The five-year period of
exclusion is the minimum established by section 1128(c)(3)(B) of the Act, 42 U.S.C.

§ 1320a-7(c)(3)(B), and is therefore reasonable as a matter of law.

III. Controlling Statutes and Regulations

Section 1128(a)(4) of the Act, 42 U.S.C. § 1320a-7(a)(4), requires the mandatory
exclusion from participation in Medicare, Medicaid, and all other federal health care
programs of “[a]ny individual or entity that has been convicted for an offense which
occurred... [after August 21, 1996] . . . under Federal or State law, of a criminal offense
consisting of a felony relating to the unlawful manufacture, distribution, prescription, or
dispensing of a controlled substance.” The terms of section 1128(a)(4) are restated
somewhat more broadly in regulatory language at 42 C.F.R. § 1001.101(d).

The Act defines “convicted” as including those circumstances: ‘“(1) when a judgment of
conviction has been entered against the individual ... bya... State... court;” or “(2)
when there has been a finding of guilt against the individual... bya... State... court;”
or “(3) when a plea of guilty or nolo contendere by the individual . . . has been accepted
bya... State...court....”; Act, section 1128(i)(1)-(3), 42 U.S.C. §§ 1320a-7(i)(1)-(3).
These definitions are repeated at 42 C.F.R. § 1001.2.
4

An exclusion based on section 1128(a)(4) is mandatory and the I.G. must impose it for a
minimum period of five years. Act, section 1128(c)(3)(B), 42 U.S.C. § 1320a-7(c)(3)(B).

IV. Findings and Conclusions
I find and conclude as follows:

1. Petitioner pleaded guilty to one felony charge of obtaining or attempting to obtain a
controlled substance by fraud, in violation of FLA. STAT. § 893.13(7)(a)(9), in Cause No.
CRO00-2250, Circuit Court for Osceola County, Florida on November 2, 2000. She was
adjudged guilty on that plea and sentenced the same day. I.G. Exs. 7, 8, 9.

2. Petitioner pleaded guilty to one felony charge of obtaining or attempting to obtain a
controlled substance by fraud, in violation of FLA. STAT. §.893.13(7)(a)(9), in Cause No.
CRO00-2567, Circuit Court for Osceola County, Florida on January 5, 2001. She was
adjudged guilty on that plea and sentenced the same day. I.G. Exs. 3, 4, 5.

3. The pleas, judgments, and sentences described above in Findings 1 and 2 each
constitute a felony “conviction” within the meanings of sections 1128(a)(4) and
1128(i)(1), (2), and (3) of the Act, and 42 C.F.R. § 1001.2.

4. By reason of the convictions described above in Findings 1, 2, and 3, Petitioner was
subject to, and the I.G. was required to impose, a period of exclusion from participation in
Medicare, Medicaid, and all other federal health care programs. Act, section 1128(a)(4).

5, The L.G. properly and reasonably set the period of Petitioner’s exclusion at five years,
the mandatory minimum period provided by law. Act, section 1128(c)(3)(B); 42 C.F.R.
§§ 1001.102(b), 1001.2007(a)(2).

6. On May 31, 2006, the I.G. notified Petitioner that she was to be excluded from
participation in Medicare, Medicaid, and all other federal health care programs for a
period of five years, based on the authority set out in section 1128(a)(4) of the Act. I. G.
Ex. 10.

7. On August 6, 2006, Petitioner perfected her appeal from the I.G.’s action by filing a
timely hearing request.

8. There are no disputed issues of material fact and summary affirmance is appropriate in
this matter. Thelma Walley, DAB No. 1367 (1992); 42 C.F.R. § 1005.4(b)(12).
V. Discussion

The essential elements necessary to support an exclusion based on section 1128(a)(4) of
the Act are: (1) the individual to be excluded must have been convicted of a criminal
offense; (2) the criminal offense must have been a felony; (3) the felony conviction must
have been for conduct relating to the unlawful manufacture, distribution, prescription, or
dispensing of a controlled substance; and (4) the felonious conduct must have occurred
after August 21, 1996. Thomas Edward Musial, DAB No. 1991 (2005); Russell A.
Johnson, DAB CR1378 (2005); Gerald A. Levitt, D.D.S., DAB CR1272 (2005); Robert
C. Richards, DAB CR1235 (2004).

Petitioner has made no effort to deny the factual basis of the I.G.’s position. Her only
claims here are those expressed explicitly in her hearing request and implicitly in her
exhibits, and none of those expressions challenges the basis for the I.G.’s determination
to exclude on the mandatory authority of section 1128(a)(4) of the Act. Thus, it is enough
to state here simply that the accepted pleas, adjudications of guilt, and judgments of
conviction supply all the essential elements in the I.G.’s case. I.G. Exs. 3, 4, 5, 7, 8, 9.

Against the fully-demonstrated presence of all four essential elements, Petitioner raises
this defense in her hearing request:

The charges I received were from the year of 2000, which is almost 7 years
ago. I have worked as a nurse since then, and I do not understand why this
is coming up at this time.

Petitioner’s Hearing Request at 1.

That may be a fair question. Part of an answer may lie in Petitioner’s alleged repeated
failures to complete rehabilitation programs and her alleged refusals to comply with her
terms of probation, which alleged failures and refusals resulted in administrative action
against her by the State of Florida’s Department of Health on September 1, 2005. I.G.
Ex. 1. But whether the I.G.’s inaction was the product of forbearance, inattention, or
stratagem is irrelevant here. For better or worse, and in spite of its potential for making
reason and conscience blush, the I.G.’s discretion as to when to impose an exclusion is
unreviewable in this forum. Thomas Edward Musial, DAB No. 1991; Samuel W. Chang,
M.D., DAB No. 1198 (1990).
6

The balance of Petitioner’s defense against the exclusion is found in the four documents
submitted as P. Exs. 1-4. I repeat my observation that Petitioner has offered no written
argument or statement in answer to the I.G.’s Brief she has placed before me only those
four documents, and I am left to infer the tenor of her defense from them without
guidance or suggestion. But their character is plain enough, each exhibit is a letter from a
health-care professional attesting to Petitioner’s good character and her successful
participation in a drug-treatment program. One writer, whose letterhead describes her as
a Licensed Mental Health Counselor and a Certified Hypnotherapist, offers it as her
professional opinion that “[n]ot allowing Ms. Mazzeo to work in the health care field,
would be like slitting her throat... it would be a crime... .” P. Ex. 2.

I have no reason to doubt Petitioner’s rehabilitation, and no wish to minimize the
testimonials of the authors of the four exhibits. But nothing in the four exhibits is
sufficient to negate the mandatory application of section 1128(a)(4). She must be
excluded from participation in Medicare, Medicaid, and all other federal health care
programs. The five-year period of exclusion proposed in this case is the irreducible
minimum required by section 1128(c)(3)(B) of the Act. Mark K. Mileski, DAB No. 1945
(2004); Salvacion Lee, M.D., DAB No. 1850 (2002). As a matter of law it is not
unreasonable. 42 C.F.R. § 1001.2007(a)(2).

Summary disposition in a case such as this is appropriate when there are no disputed
issues of material fact and when clear and undisputed facts, not subject to conflicting
interpretation, demonstrate that one party is entitled to judgment as a matter of law.
Thelma Walley, DAB No. 1367. Summary disposition is authorized by the terms of 42
C.F.R. § 1005.4(b)(12). This forum is guided by FED. R. CIV. P. 56 in applying that
regulation. Robert C. Greenwood, DAB No. 1423 (1993). The material facts in this case
are clear, undisputed, and unambiguous. They support summary disposition as a matter
of law. This Decision issues accordingly.

VI. Conclusion

For the reasons set out above, the I.G.’s Motion for Summary Affirmance must be, and is,
GRANTED. The I.G.’s exclusion of Petitioner Kimberly Mazzeo from participation in
Medicare, Medicaid, and all other federal health care programs for a period of five years,
pursuant to the terms of section 1128(a)(4) of the Act, is sustained.

/s/
Richard J. Smith
Administrative Law Judge


Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

In the Case of: )
)
Rehabilitation & Care Center of ) Date: May 1, 2007

Jackson County, )
(CON: 14-5395) )
)
Petitioner, )
)

-Vv.- ) Docket No. C-03-418

) Decision No. CR1590
Centers for Medicare & Medicaid )
Services. )
)

DECISION

I sustain the determination of the Centers for Medicare & Medicaid Services (CMS) to
impose a per-instance civil money penalty (CMP) totaling $4,050 against Petitioner,
Rehabilitation & Care Center of Jackson County. I deny Petitioner’s motion for a
directed finding in its favor.

I. Background

On February 18, 2003, the Illinois Department of Public Health (IDPH) completed a
survey of Petitioner’s facility. On the basis of this survey, CMS determined that
Petitioner failed to comply substantially with two participation requirements stated at

42 C.F.R. §§ 483.20(b) (Resident Assessment, Tag F 272) and 483.25(h)(2) (Quality of
Care, Tag F 324). Both deficiencies were cited under the past noncompliance data Tag F
698. By letter dated August 12, 2003, CMS imposed upon Petitioner a per-instance CMP
of $1,000 for the past noncompliance identified at 42 C.F.R. §§ 483.20(b) (Resident
Assessment, Tag F 272) and a per-instance CMP in the amount of $3,050 for the past
noncompliance identified at 42 C.F.R. §§ 483.25(h)(2) (Quality of Care, Tag F 324).
CMS also imposed a two-year prohibition against offering a Nurse Aide Training and/or
Competency Evaluation Program (NATCEP), effective February 18, 2003.
2

Petitioner requested a hearing on May 1, 2003, and the case was assigned to me for a
hearing and a decision. I conducted a hearing in Benton, Illinois, from September 21-22,
2004. At the hearing, CMS offered into evidence 34 exhibits (CMS Exs. 1-34) and
Petitioner offered into evidence 19 exhibits (P. Exs. 1-19). I admitted into evidence CMS
Exs. 1-34 and P. Exs. 1-19. At the hearing, Petitioner moved for a directed finding. I
deny Petitioner’s motion for a directed finding.

CMS presented two witnesses, both surveyors, Robin Martin, Registered Nurse (R.N.),
and Karen Lapington, sanitarian. Petitioner presented seven witnesses: Merle Taylor,
Administrator; Stephanie Green, Director of Nurses (DON); Laura Ticer, Licensed
Practical Nurse (LPN) Supervisor and Care Plan Coordinator; Vickie Holford, R.N., a
restorative and rehabilitation nurse; Regina Pierson, Environmental Services Director;
Robin Morse, Certified Nurse Assistant (CNA); and Dr. Dale Blaise, Medical Director
and attending physician.

CMS’s post-hearing brief (CMS Br.) was received on December 21, 2004. On January
31, 2005, Petitioner filed its post-hearing brief (P. Br. ), accompanied by one attachment.
On February 18, 2005, CMS filed it post-hearing reply brief (CMS Reply Br.).

II. Applicable law and regulations

Petitioner is considered a long-term care facility under the Social Security Act (Act) and
regulations promulgated by the Secretary of Health and Human Services (Secretary). The
statutory and regulatory requirements for participation by a long-term care facility are
found at sections 1819 and 1919 of the Act and at 42 C.F.R. Part 483.

Sections 1819 and 1919 of the Act invest the Secretary with authority to impose CMPs
against a long-term care facility for failure to comply substantially with federal
participation requirements.

Pursuant to the Act, the Secretary has delegated to CMS and the states the authority to ~
impose remedies against a long-term care facility that is not complying substantially with
federal participation requirements. 42 C.F.R. Part 488 provides that facilities
participating in Medicare may be surveyed on behalf of CMS by state survey agencies in
order to determine whether the facilities are complying with federal participation
requirements. 42 C.F.R. §§ 488.10-488.28. The regulations contain special survey
conditions for long-term care facilities. 42 C.F.R. §§ 488.300-488.335. The regulations
at 42 C.F.R. Part 488 give CMS a number of different remedies that can be imposed if the
3

facility is not in compliance with Medicare requirements. Under Part 488, a state or CMS
may impose a per-instance or per-day CMP against a long-term care facility when a state
survey agency concludes that the facility is not complying substantially with federal
participation requirements. 42 C.F.R. §§ 488.406, 488.408, 488.430.

The regulations specify that a CMP that is imposed against a facility can be either a per
day CMP for each day the facility is not in substantial compliance, or a per-instance CMP
for each instance that a facility is not in substantial compliance. 42 C.F.R. § 488.430(a).
When penalties are imposed for an instance of noncompliance, the penalties will be in the
range of $1,000-$10,000. 42 C.F.R. § 488.438(a)(2).

The regulations define the term “substantial compliance” to mean “‘a level of compliance
with the requirements of participation such that any identified deficiencies pose no greater
tisk to resident health or safety than the potential for causing minimal harm.” 42 C.F.R.

§ 488.301.

Substantial noncompliance that is immediate jeopardy is defined as “‘a situation in which
the provider’s noncompliance with one or more requirements of participation has caused,
or is likely to cause, serious injury, harm, impairment, or death to a resident.” Jd.

Substandard Quality of Care is defined as “one or more deficiencies related to
participation requirements under § 483.13, Resident behavior and facility practices,

§ 483.15, Quality of life, or § 483.25, Quality of care... , which constitute immediate
jeopardy to resident health or safety ....” A finding of substandard quality of care,
triggers an extended survey, which in turn results in the loss of approval for a facility of
its NATCEP. 42 C.F.R. § 498.3(b)(13), (14)(ii).

The Act and regulations make a hearing before an administrative law judge (ALJ)
available to a long-term facility against whom CMS has determined to impose a CMP.
Act, section 1128A(c)(2); 42 C.F.R. §§ 488.408(g), 498.3(b)(12), (13). The hearing
before an ALJ is a de novo proceeding. Anesthesiologists Affiliated, et al., DAB CR65
(1990), aff'd, 941 F.2d 678 (8" Cir. 1991). A facility has a right to appeal a “certification
of noncompliance leading to an enforcement remedy.” 42 C.F.R. § 488.408(g)(1); see
also 42 C.F.R. §§ 488.330(e) and 498.3. However, the choice of remedies by CMS or the
factors CMS considered when choosing remedies are not subject to review. 42 C.F.R.

§ 488.408(g)(2). A facility may only challenge the scope and severity level of
noncompliance found by CMS if a successful challenge would affect the amount of the
CMP that could be collected by CMS or impact upon the facility’s nurse aide training
program. 42 C.F.R. §§ 498.3(b)(14) and (d)(10)(i). CMS’s determination as to the level
4

of noncompliance “must be upheld unless it is clearly erroneous.” 42 C.F.R.

§ 498.60(c)(2). This includes CMS’s finding of immediate jeopardy. Woodstock Care
Center, DAB No. 1726, at 9, 38 (2000), aff'd, Woodstock Care Center v. U.S. Dept. of
Health and Human Services, 363 F.3d 583 (6th Cir. 2003).

When a penalty is imposed and appealed, CMS must make a prima facie case that the
facility has failed to comply substantially with federal participation requirements. To
prevail, a long-term care facility must overcome CMS’s showing by a preponderance of
the evidence. Batavia Nursing and Convalescent Center, DAB No. 1904 (2004); Batavia
Nursing and Convalescent Inn, DAB No. 1911 (2004); Emerald Oaks, DAB No. 1800
(2001); Cross Creek Health Care Center, DAB No. 1665 (1998); Hillman Rehabilitation
Center, DAB No. 1611 (1997), aff'd, Hillman Rehabilitation Center v. U.S. Dept. of
Health and Human Services, No. 98-3789 (D.N.J. May 13, 1999).

III. Issues
The issues in this case are:

(1) whether CMS has shown a basis upon which to assess penalties against
Petitioner for substantial noncompliance with the requirements for participation in
Medicare and Medicaid; and, if so,

(2) whether the amount of the assessed penalties is reasonable.
IV. Findings of fact and conclusions of law

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

Prior to discussing the individual deficiencies, it is necessary to address the issue of the
credibility of the surveyors. Petitioner attacks the credibility of the surveyors based on
Surveyor Martin’s lack of recent nursing experience (Surveyor Martin has not worked in
a nursing facility since 1995) and Surveyor Lapington’s lack of a medical background
(Surveyor Lapington is a sanitarian and has never worked in a long-term care facility).
Petitioner claims that the surveyors are not qualified to give expert opinions on the
foreseeability of the January 19, 2003 entrapment incident at issue before me. This is an
administrative proceeding to which the formal rules of evidence do not strictly apply.
However, if I apply Fed. R. Evid. 702 and the decision in Daubert v. Merrell Dow
Pharmaceuticals, Inc., 509 U.S. 579 (1993), I find that the two surveyors have scientific,
technical, or other special knowledge as a surveyor or nurse surveyor that can help me
5

make a decision on the facts in issue. Thus, it was appropriate to allow them to testify to
their opinions based upon the evidence, giving such weight as is appropriate in light of
the factors listed in Fed. R. Evid. 702 — sufficiency of facts or data, reliability of
principles or methods, and reliability of the application of principles or methods to the
facts. Further, 42 C.F.R. § 488.26(c)(3) establishes a presumption of professional
competence for surveyors. Petitioner bears the burden to rebut this presumption. In this
case, the fact that Surveyor Martin has been out of actual nursing practice for a period of
years! does not detract from her credibility or from the probative value of her testimony
absent some evidence from a more credible source indicating that her testimony is in error
rather than just disputed. Also, the fact that Surveyor Lapington is a sanitarian and has no
medical training does not detract from the credibility due her as a result of her training as
a surveyor’ and her experience as a surveyor of long term care facilities for 12 years.’
Petitioner also misses the primary point of the surveyors’ testimony, which is to allow
them to elaborate upon the reasons why they alleged deficiencies and to give Petitioner an
opportunity to cross-examine them.

I found the testimony of Surveyors Martin and Lapington to be more credible, unbiased,
objective, and consistent than that of the other witnesses who testified. I found their
testimony to be supported by the documentary evidence and more persuasive than that of
the other witnesses who testified. I, therefore, gave the testimony of the two surveyors
greater weight in my deliberations.

A, Petitioner’s motion for a directed finding is denied.

At the close of CMS’s case-in-chief, Petitioner made an oral motion for a directed
finding. A motion for directed finding or verdict is granted when all the evidence, viewed
in the light most favorable to the opponent, favors the movant so that no contrary verdict
could stand. In other words, a directed verdict should be granted if the opponent, CMS,
has not established a prima facie case. I deny Petitioner’s oral motion for a directed
finding. CMS has clearly established a prima facie case, as | discuss further below.

' Surveyor Martin has been a surveyor for eight years, had 22 years of nursing
experience, and has had experience providing direct care to residents in nursing homes. Tr. 37,
CMS Ex. 31.

? Surveyor Lapington testified the she received training on the proper use of side rails,
including the difference between using side rails as restraints or as enablers and how to assess the
need and purpose of side rails. Tr. 68.

3 Surveyor Lapington has been involved with other surveys where a resident has become
entrapped between side rails and a mattress, although none of those residents died as a result of
the entrapment. Tr. 90.
6

B. Petitioner failed to comply substantially with the requirements of
42 C.F.R. § 483.20(b).

The February 18, 2003 survey found that Petitioner was not in substantial compliance
with the regulation at 42 C.F.R. § 483.20(b) which provides:

(b) Comprehensive Assessments.

(1) Resident assessment instrument. A facility must make a comprehensive
assessment of a resident’s needs, using the resident assessment instrument
(RAJ) specified by the State. The assessment must include at least the
following:

(xv) Special treatments and procedures.

The Resident Assessment Instrument (RAI) consists of three basic components: the
Minimum Data Set (MDS), the Resident Assessment Protocols (RAPs), and the RAI
Manual (RAI Manual).* CMS contends that Petitioner failed to comprehensively assess
whether Resident 1 needed to continue using half side rails. CMS argues that the use of
quarter, half, and full side rails have risks associated with them and, therefore, a facility
has the duty, under section 42 C.F.R. § 483.20(b)(1)(xv), to assess and address those
risks. CMS Br. at 10. This deficiency, as well as the deficiency discussed in Part IV.C.
of this Decision, involve the same resident, Resident 1.

Resident 1 was an 88 year old female whose diagnoses included generalized weakness,
Alzheimer’s disease, dementia, and organic brain syndrome. Tr. 39, 71, 366; CMS Ex. 8,
at 1. Resident 1 was fed through a gastric tube. Jd. Resident 1’s most recent MDS was
dated November 25, 2002. The November 25, 2002 MDS documented that Resident 1
had short and long-term memory problems, moderately impaired cognitive skills, was
unable to understand others or make herself understood, resisted care, was non-
ambulatory, and was totally dependent on staff for bed mobility, transfers, toileting, and
other activities of daily living. Tr. 39-40, 73; P. Ex. 18, at 2-3.

Resident 1 had half side rails on her bed. She was unable to use her half side rails to
reposition herself. Tr. 234, 247, 284, 295. However, Resident 1 could hold onto the half
side rails if a staff member placed her hand on the half side rail. Tr. 174, 284, 295.
Resident 1 was assessed at risk of falls related to her attempts to self transfer off of her

* The MDS, RAPs, and Manual are found at http://www.cms.hhs.gov/quality/mds20/.
7

bed and Petitioner had documented falls on January 12, 2000, November 1, 2001,
December 15, 2001, March 2, 2002, and March 12, 2002. Tr. 45, 78. The falls on
November 1, 2001, December 15, 2001, March 2, 2002, and March 12, 2002, were all
falls from Resident 1’s bed while her half side rail was in use. CMS Exs. 9, 10, 14, at 1-
2.

On March 12, 2002, at 12:20 a.m., Resident 1 was found on the floor with her back
against the bed, holding onto one of the half side rails with both hands, with her neck
wedged between the half side rail and the mattress. CMS Exs. 10, 16. Resident 1 was not
able to remove herself from between the mattress and the half side rail, but was uninjured
as a result of this fall. Tr. 45; CMS Ex. 10.

At the time of the March 12, 2002 fall, Resident 1’s care plan already documented her
risk for falls as a result of her attempts to self transfer. CMS Ex. 16, at 1, 6, 13, 18, 23,
27, 31, 34, 38, 42. The approaches of the facility to address Resident 1’s risk for falls
included: 30 minute monitoring; ensuring she had a hazard free environment; using right
and left half side rails to assist in bed mobility; and scheduled toileting. Jd. After the
March 12, 2002 fall, where Resident 1’s neck was found wedged between the half side
rail and the mattress, no changes were made to her care plan. Jd. There was no
documentation to show that Petitioner’s staff ever considered discontinuing the use of
half side rails after the March 12, 2002 fall, even though she had been found with her
neck wedged between the half side rail and the mattress. Tr. 333-34.

Resident 1’s medical chart included her most recent side rail assessment, which was dated
prior to the March 12, 2002 fall. CMS Ex. 17. The side rail assessment showed that the
purpose of the use of side rails was to assist in bed mobility, transfers, and safety
concerns. Tr. 163; CMS Ex. 17. The side rail assessment did not indicate that the
benefits of using side rails outweighed the risk of using side rails. CMS Ex. 17. The side
rail assessment was not updated at any time after the March 12, 2002 fall. There is no
documentation to show that, after the March 12, 2002 incident, Petitioner’s staff ever
reconsidered or reweighed the benefits and risks of using side rails. Resident 1 did not
fall again until January 19, 2003.

On January 19, 2003, at 4:05 a.m., CNA Morse found Resident 1 on the floor next to her
bed with her head wedged between the half side rail and the mattress. Tr. 392, 412; CMS
Ex. 22, at 1. CNA Morse determined that Resident 1 had no pulse or heartbeat. LPN
Kupczak confirmed that Resident 1 had no pulse, respiration, and blood pressure. Jd.
The DON, Dr. Blaise (Resident 1’s attending physician and Petitioner’s Medical
8

Director), the sheriff's department, and the deputy coroner were all notified. The police
report indicted that Resident 1’s death was accidental strangulation. CMS Ex. 12. The
death certificate listed the cause of death as asphyxiation-positional, extrinsic
compression of the neck, and neck trapped under the bed rail. CMS Ex. 13.

After Resident 1’s death, Petitioner reassessed all the residents that used side rails. This
reassessment resulted in three changes. CMS Ex. 1, at 3-4. Petitioner also checked all
side rails to determine if the side rails were functioning properly and trained its staff
regarding alarms and the use of side rails. CMS Ex. 23.

Entrapment of a resident between a mattress and side rails is a known risk in the nursing
home industry. For example, in Maine Veterans’ Home-Scarborough, DAB No. 1975, at
8 (2005), an appellate panel of the Departmental Appeals Board (Board) cited to a 2001
Veterans’ Administration Patient Safety Alert concerning dangers posed by bed rail
entrapment which directed VA facilities to measure gaps between bed rails and
mattresses, and a 1995 Food and Drug Administration (FDA) Safety Alert to long-term
care facilities on dangers posed by gaps associated with bed rails, particularly to frail and
confused residents. In Wellington Specialty Care & Rehabilitation Center, DAB CR548
(1998), the ALJ discussed the FDA Alert, stating:

[Slide rails can be dangerous to residents of long-term care facilities. There exists
a risk that some residents under certain circumstances may suffer injuries from
side rails . . . on occasion, individuals have become wedged in the gaps between
side rails, resulting in injuries or death to those individuals . . .. The dangers posed
by side rails impose on long-term care facilities a duty to assess and address the
risk of using side rails... .On August 21, 1995, the Food and Drug
Administration (FDA) sent an “Alert” to hospitals and long term care facilities
which warned them of the dangers that side rails posed . . . . This Alert stated that
since January 1990 [a period of a little over five and one half years], the FDA had
received 102 reports of incidents involving entrapment of individuals in hospital
bed side rails . . .. The FDA noted that it had received reports of 68 deaths, 22
injuries, and 12 entrapments without injuries occurring in hospitals, long-term care
facilities, and private homes.

Id. at 11-12. The FDA Alert shows that gaps between side rails and mattresses pose a
real risk of harm, injury, or even death to residents in nursing homes and is a risk
generally known in the nursing home industry.
9

CMS, in its brief, also referred to the FDA Alert mentioned in Wellington. Petitioner
argues that these FDA warnings were “‘an impermissible attempt by CMS to introduce
materials from the Food and Drug Administration . .. when CMS failed to offer any such
evidence in this case.” P. Br. at 23. I find that I can consider the FDA Alert for the
purpose of showing that entrapment is a risk known to the nursing home industry and not
for the purpose of showing that Petitioner, in particular, received such written warnings
from the FDA.

In addition to the known risk of entrapment from the use of side rails, in the case before
me, Resident 1 was particularly at risk from entrapment because she was weak and
confused. Petitioner’s care plan documented that Resident 1 was at risk for falls relating
to her attempts the self transfer. CMS Ex. 16, at 1, 6, 13, 18, 23, 27, 31, 34, 38, 42.
Resident 1 was diagnosed with Alzheimer’s Disease, dementia, and generalized
weakness. Tr. 39, 71, 366; CMS Ex. 8, at 1. Resident 1 was weak, confused, and would
be less able to extricate herself should she, in fact, become entrapped. Surveyor Martin
testified that residents who are diagnosed with weakness, confusion, Alzheimer’s Disease
and dementia, like Resident 1, are at increased risk of becoming entrapped between their
side rails and mattresses. Tr. 42. Most telling, however, was that Resident 1 had already
had a prior experience of being entrapped on March 12, 2002. Resident 1 was discovered
prior to suffering any injuries, but was unable to extricate herself during the March 12,
2002 incident. Fortunately, on that occasion, Resident 1 was uninjured. As a long-term
care SNF, however, Petitioner knew or should have known of the risks of entrapment
from the use of side rails. Indeed, Petitioner had actual notice, that Resident 1 was at
particular risk of entrapment because of the incident on March 12, 2002.

Section 483.20(b) requires facilities to engage in a comprehensive assessment of a
resident's needs. Evaluating the benefits and risks of a particular service initiated by a
facility, such as the use of side rails, must be part of a comprehensive assessment.
Resident safety is a basic facility responsibility. 42 C.F.R. § 483.25(h). Survey
instruments, such as the RAI, cannot incorporate every possible factor a facility should
consider in a resident assessment. Maine Veterans’ Home-Scarborough, DAB No. 1975,
at 17. The Board in Maine Veterans’ Home-Scarborough, citing to the RAI Manual,
stated that “completion of the MDS/RAPs does not necessarily fulfill a facility's
obligation to perform a comprehensive assessment. Facilities are responsible for
assessing areas that are relevant to individual residents regardless of whether or not the
appropriate areas are included in the RAI.” Jd. The scope of the RAI does not limit the
facility's responsibility to assess and address all care needed by the resident. Jd. at 17-18.

The Board in Maine Veterans’ Home-Scarborough, further explained that this
interpretation is reasonable because:
10

(1) the wording of section 483.20(b)(1) is that an assessment “must include at
least” certain specified elements, and more generally refers to a “comprehensive ”
assessment of a resident's needs; (2) designing and using an instrument that
describes every conceivable permutation of care needed by the nursing home
population is impracticable if not impossible, and (3) limiting comprehensive
assessments to a specific instrument would subject residents to the risk of having
care needs not assessed because they were not on the instrument.

Td. at 18.

Resident 1’s side rail assessment, dated February 16, 2002, was not comprehensive
because there was no reassessment done following her March 12, 2002 fall. No
documentation exists in Resident 1’s medical record to show that the use of side rails was
ever reevaluated as to whether its benefits outweighed its risks and no documentation
exists that alternatives to the use of side rails to prevent falls were considered. Tr. 46, 47.
Resident 1 had two falls following the February 16, 2002 side rail assessment and prior to
the entrapment incident that resulted in her death. One fall occurred on March 2, 2002,
and the other one occurred on March 12, 2002. According to Surveyor Lapington, both
falls related to Resident 1’s bed and should have resulted in a new side rail assessment.
Tr. 79, 85. In referring to the March 12, 2002 fall where Resident 1’s neck became
entrapped between her side rail and mattress, Dr. Blaise, Petitioner’s Medical Director
and Resident 1’s treating physician, testified that Resident 1 could have bruised herself,
suffered musculoskeletal injuries, or her airway could have become obstructed. Tr. 392,
394. Thus, Petitioner had notice that Resident 1 could become entrapped. Petitioner
should have known that such entrapment could harm Resident 1. Thus, Petitioner, was
obligated to at least reassess the risks of using side rails following the March 12, 2002
fall.

I note CMS’s argument that even prior to the March 12, 2002 fall, the February 16, 2002
side rail assessment was not comprehensive because it did not show that there was an
initial assessment to indicate that the benefits of using the side rails outweighed the risks
of using the side rails. Tr. 44; CMS Ex. 17, at 1. No documents exist to show that the
interdisciplinary team that made the recommendation for the use of side rails ever initially
considered the risks of side rails or possible alternative interventions to the use of side
rails. The assessment form merely indicated that the side rails were being used for safety
concerns and to assist with bed transfers and bed mobility and that the side rails were not
considered restraints. CMS Ex. 17. CMS also argues that the side rail assessment was
not comprehensive because it failed to accurately reflect Resident 1’s need for the side
rails. The side rail assessment indicated that the rails were to be used at all times when
Resident 1 was in bed. Jd. However, Resident 1’s care plan indicated that the side rails
11

were to be used on an as needed basis for transfers and bed mobility. CMS Ex. 16, at 1. I
find that I need not address these arguments because it is clear that Petitioner had a duty
to reassess Resident 1’s use of side rails following the March 12, 2002 fall that resulted in
her entrapment, and it did not do so.

Petitioner counters by claiming that the half side rails were needed all the time because
Resident 1 was fed through a gastric tube which required that the head of the bed be
elevated. A review of the evidence before me shows that neither the February 16, 2002
side rail assessment nor Resident 1’s care plan corroborates this claim. CMS Exs. 16, 17.

When a significant change in the condition of a resident occurs, the regulations require
that a revised MDS be completed. 42 C.F.R. § 483.20(b)(2). Petitioner argues that a
reassessment was not required because Resident 1 did not experience a significant change
in her condition after the March 12, 2002 fall. While Petitioner might be correct that
Resident 1’s condition did not change, the March 12, 2002 fall placed Petitioner on notice
that a risk, possibly a lethal risk, existed as to use of side rails with Resident 1. As
previously noted, there is no documentation to show that, after the March 12, 2002
incident where Resident 1’s head was found wedged between the half side rail and the
mattress, Petitioner’s staff ever reconsidered or reweighed the benefits and risks of using
side rails. As previously discussed, a resident who is weak, confused, and has
Alzheimer’s Disease or dementia, is at increased risk of being entrapped. Resident 1 was
such a resident even before March 12, 2002. However, after the March 12, 2002 fall,
Petitioner had actual notice that Resident 1 could be entrapped between her side rails and
her mattress and a comprehensive assessment requires that such a risk be weighed against
the benefits and alternatives.

In addition, Petitioner argues that the purpose of its side rail assessment was only to
determine whether the side rails served as restraints and, therefore, a reassessment was
not needed. This argument is unavailing. Whatever the reason for the use of side rails,
whether as a restraint, a mobility device, or a fall prevention measure, the risks of side
rails remains the same. In the matter before me, where Resident 1 had already
experienced an entrapment episode, Petitioner had a duty to assess the risks and benefits
of the continued use of side rails and consider alternatives. After the March 12, 2002 fall,
Petitioner continued to assess Resident 1 to be at risk for falls on her care plan. Petitioner
never modified its care plan after the March 12, 2002 fall to reflect any interventions that
could prevent or decrease the risk of entrapment.
12

C. Petitioner failed to comply substantially with the requirements of
42 C.F.R. § 483.25(h)(2).

The February 18, 2003 survey found that Petitioner was not in substantial compliance, at
an immediate jeopardy level (level J), with the regulation at 42 C.F.R. § 483.25(h)(2)
which provides:

Each resident must receive and the facility must provide the necessary care and
services to attain or maintain the highest practicable physical, mental, and psycho
social well-being, in accordance with the comprehensive assessment and plan of
care.

(h) Accidents. The facility must ensure that -

(2) Each resident receives adequate supervision and assistance
devices to prevent accidents.

This regulation does not require a facility to be free of all accidents; it does not impose
strict liability on a facility for accidents that a resident may sustain. See Koester Pavilion,
DAB No. 1750 (2000); Heath Nursing and Convalescent Center, DAB CR610 (1999);
Woodstock Care Center, DAB No. 1726 (2000); Carehouse Convalescent Hospital, DAB
CR729 (2001); Price Hill Nursing Home, DAB CR745 (2001); Hermina Traeye
Memorial Nursing Home, DAB CR756 (2001). In other words, simply because an
accident occurred does not necessarily mean that a facility failed to substantially comply
with regulatory requirements. In cases concerning compliance with 42 C.F.R. §
483.25(h), the focus is on the language of the regulation; i.e., the facility must ensure
each resident receives adequate supervision to prevent accidents according to a
comprehensive assessment and a plan of care (emphasis added). The facility’s duty, as
stated in the regulation, is an affirmative duty.

The Board in Koester Pavilion, DAB No. 1750, at 24 (2000) stated that “a facility is not
required to do the impossible or be a guarantor against unforeseeable occurrences, but is
required to do everything in its power to prevent accidents.” The facility’s duty, pursuant
to 42 C.F.R. §§ 483.25(h)(1) and (2), is expressed in a slightly different way in
Woodstock Care Center, DAB No. 1726 (2000). In that case, the Board found that a
facility is obligated to take measures that are designed, to the extent that is practicable, to
assure that residents do not sustain accidents that are reasonably foreseeable. The fact
that an accident actually occurred in a nursing home does tend to show that the facility’s
supervision was inadequate to prevent the occurrence; that is, the facility did not do
13

everything in its power to prevent its occurrence. This is particularly true if, as in the case
before me, the facility has had notice of a prior occurrence so that the potential for a
resident’s accident is foreseeable.

The question here is whether Petitioner took measures, to the extent practicable, to assure
that Resident 1 did not become entrapped, given that Resident 1 had a previous episode of
entrapment on March 12, 2002.

Petitioner asserts that never in the history of the facility had such an unfortunate accident
occurred, and never had a resident died in a manner like Resident 1. P. Br. at 3.
Petitioner argues, and its Administrator, Merle Taylor, so testified, that there was no
reason to believe such an incident of entrapment resulting in the death of a resident could
occur. P. Br. at 3; Tr. 152. Petitioner’s other witnesses also opined that the January 19,
2003 incident was unforeseeable.

Petitioner’s argument that the entrapment episode that resulted in R1’s death was an
unforeseeable accident must fail because, given the entrapment episode of March 12,
2002, the January 19, 2003 entrapment episode was certainly reasonably foreseeable. As
I discussed in Part IV.B. of this Decision, entrapment as a result of the use of side rails is
a known risk for residents in nursing homes. Dr. Blaise, Petitioner’s Medical Director
and Resident 1’s treating physician, testified that Resident 1 could have bruised herself,
suffered musculoskeletal injuries, or her airway could have become obstructed as a result
of the March 12, 2002 incident. Tr. 392, 394. Petitioner’s staff members Merle Taylor,
Stephanie Green, Laura Ticer, Vickie Holford, and Dr. Blaise, each testified that he or she
was aware of the previous March 12, 2002 entrapment incident. Tr. 154-55, 182, 240-41,
298, 314, 375, 391-92. Further, Merle Taylor and Dr. Blaise both testified that they were
aware of the risks side rails posed to nursing home residents. Tr. 154, 390, 392, 394.
Since entrapment had happened once before, on March 12, 2002, involving the same
resident, it is not unforeseeable that it could happen again. In fact, the position in which
Resident 1 was found after both incidents was almost exactly the same. In both instances,
Resident 1’s neck was wedged between the mattress and the side rail. I do not find that
for a risk to be foreseeable, it must have previously materialized. But where such a risk
has previously materialized, Petitioner has a particularly heavy burden to show that an
accident was unforeseeable. Petitioner has not met this burden.

Resident 1 was the type of resident who is most vulnerable to entrapment because she
may move without regard to her own safety, was more likely to become entrapped, was
weak and confused, and would be less able to extricate herself from a gap. First,
Petitioner failed to identify the hazard of further entrapment after the March 12, 2002
entrapment episode. Thereafter, Petitioner did nothing to prevent another occurrence.
Petitioner failed to change Resident 1’s care plan, or reassess the use of side rails, or
14

consider alternatives to the use of side rails, as discussed in Part IV.B. of this Decision.
Petitioner failed to provide adequate supervision or assistive devices to prevent another
entrapment. Evidence was presented that Resident 1’s room could not be seen from the
nurses station. Tr. 237. Under section 483.25(h), a facility must identify and remove
hazards, where possible, or, where the hazard is unavoidable because of other resident
needs, a facility must manage the hazard by reducing the risk of accident to the extent
possible. Ensuring that a gap between the mattress and the side rail was very small, by
the use of padded side rails or by some other means, would have reduced the risk of
entrapment.

As noted above, Petitioner’s staff members Merle Taylor, Stephanie Green, Laura Ticer,
Vickie Holford, and Dr. Blaise, each testified that he or she was aware of the March 12,
2002 entrapment incident. Tr. 154-55, 182, 240-41, 298, 314, 375, 391-92. Further,
Merle Taylor and Dr. Blaise both testified that they were aware of the risks side rails
posed to nursing home residents. Tr. 154, 390, 392, 394. There is no doubt that
Petitioner had notice of the risk of entrapment for Resident | and that Resident 1 had
been unable to free herself during the previous incident of entrapment.

Under section 483.25(h), Petitioner has a duty to take all reasonable steps that it could to
prevent an accident. Petitioner could have implemented alternative interventions to
prevent Resident 1 from becoming entrapped and still address Resident 1’s risk of falling.
Testimony was presented that possible alternative interventions included: removing the
side rails entirely and placing Resident 1 in a low bed with padding around her bed;
providing Resident 1 with a bed alarm; using a concave mattress; or padding the side rails
with a bed bolster to eliminate the space between the side rails and the mattress. Tr. 43.
Petitioner did not implement alternative interventions and presented no evidence that it
even considered alternative interventions. In fact, the evidence shows that one
intervention, the use of a sentinel alarm, was discontinued in October 2002. P. Br. at 17.
Instead, Petitioner argues that it reinforced interventions already in place. Tr. 183, 315.
However, the interventions already in place failed to prevent the March 12, 2002
entrapment incident and, therefore, were not sufficient.

Petitioner asserts that “[iJn assessing R1, Jackson County determined that this incident [of
March 12, 2002] occurred because R1 would become agitated when incontinent, and
would attempt to get out of bed in the morning hours to go to the bathroom.” P. Br. at 16.
As a result, Petitioner responded by continuing scheduled toileting in order to decrease
agitation which would lead to attempts to self-transfer. P. Exs. 1, at 4; 10, at 1-21; Tr.
315-16, 395. Monitoring every 30 minutes was also continued. P. Ex. 4. A call light and
a sentinel alarm were used to monitor Resident 1. /d. As noted above, however, the
sentinel alarm was discontinued in October of 2002. P. Ex. 5, at 1. According to
Petitioner, the sentinel alarm was discontinued because it was no longer needed. P. Br. at
15

17. I take note that Petitioner discontinued the use of the sentinel alarm, which was one
of the possible interventions that CMS’s surveyors testified was available for use with
Resident 1.

Petitioner also claimed that the type of mattress was changed.° Tr. 345. Petitioner’s
Rehabilitation Nurse, Vickie Holford, testified that Petitioner changed the type of
mattress that Resident 1 was using after the March 12, 2002 incident. Tr. 340-46. I give
little weight to this testimony because this testimony is not supported by anything in the
record before me. Petitioner’s request for Informal Dispute Resolution (IDR) did not
mention a change of mattress after March 12, 2002. P. Ex. 2. Resident 1’s care plan does
not mention a change of mattress. CMS Ex. 16. No documentation in evidence before
me indicates a change of mattress. DON Green did testify that it was her “understanding’
that Resident 1’s mattress had been changed sometime between March 2002 and January
2003. Tr. 253. However, DON Green also admitted that there was no documentation to
show that Resident 1’s new mattress had been evaluated for appropriateness of use with
her side rails. Tr. 253-54. Not all mattresses can be safely used with all side rails. Good
Samaritan Center, DAB CR884 (2002). Therefore, even if I accept as true that Resident
1’s mattress had been changed, it would be Petitioner’s burden to show that the type of
mattress used with the type of side rails in use on Resident 1’s bed was a safe
combination. Petitioner did not sustain this burden.

”

Petitioner argues that Resident 1 did not fall from her bed for a 10 month period from
March 2002 until January 2003 and, therefore, it was providing Resident 1 with adequate
supervision and assistance devices. I find Petitioner’s reasoning to be unpersuasive. The
absence of a fall or an entrapment does not necessarily lead to the conclusion that
Resident 1 was being provided with adequate supervision and assistance devices.
Therefore, I reject Petitioner’s argument. Further, Petitioner claims that Resident 1 no
longer attempted to transfer out of her bed during this 10-month period and, therefore, the
incident of January 19, 2003 was unforeseeable. Even if I take this claim to be true,
Petitioner’s argument is unavailing. Petitioner’s argument is undercut by the fact that it
still assessed Resident | to be at risk for falls up to the time of Resident 1’s entrapment
that led to her death. CMS Ex. 16. Petitioner had still assessed Resident | to be at risk
for falls in spite of the fact that there were no falls for a 10-month period, and in spite of
its claim that Resident 1 no longer attempted to transfer from her bed.

* Petitioner asserts that an air pressure mattress on Resident 1's bed was changed to an
egg crate mattress. Tr. 345; P. Br. at 17.
16

Petitioner also argues that Dr. Blaise, Resident 1’s physician, did not order that the side
rails be discontinued, and that Resident 1’s family did not request that the side rails be
removed. This argument is also unavailing because under the regulations it is the
facility’s responsibility to ensure that the resident receives adequate supervision and
assistance devises. Therefore, Petitioner’s actions or inactions cannot be blamed on the
Resident’s physician or family.

Further, Petitioner argues that side rails were needed because the head of Resident 1’s bed
had to be elevated at least to a 35 degree angle because Resident 1 was being fed through
a gastric tube. Tr. 369. Resident 1’s care plan does not support this assertion. CMS

Ex. 16. Surveyors Martin and Lapington, as well as Petitioner’s DON, Stephanie Green,
testified that the use of half side rails is not related to the use of a gastric tube. Tr. 44,
76-78, 238. Petitioner’s Rehabilitation Nurse, Vickie Holford, testified that the use of
half side rails was not part of Petitioner’s protocol for gastric feeding, but then changed
her testimony stating that she was unsure of the policy for gastric feeding. Tr. 339.
Petitioner’s argument is not supported by the evidence before me, but even if it was,
Petitioner still had to assess the risks and benefits of using side rails for Resident 1 and
consider alternative interventions that would reduce the risk of entrapment. Where the
hazard, such as side rails, is unavoidable because of other resident needs, managing the
hazard by reducing the risk of accident to the extent possible is a facility’s responsibility.

D. CMS’s determination that Petitioner’s noncompliance with the
regulation found at 42 C.F.R. § 483.25(h)(2) was at the immediate
jeopardy level is not clearly erroneous.

In this case, CMS determined that the facility was not in substantial compliance with the
regulation found at 42 C.F:R. § 483.25(h)(2) at an immediate jeopardy level. As noted
above, CMS assessed a per-instance CMP of $3,050.

Appeal rights attach to certain initial determinations made by CMS as set forth in the
regulations. The level of noncompliance, in this case immediate jeopardy, can be
appealed but only if the range of CMP that would be collected could change or if the
facility’s nurse’s aide training program would be affected due to a finding of substandard
quality of care. 42 C.F.R. §§ 498.3(b)(14)(i), (ii) and 498.3(d)(10)(i), (ii).

A per-instance CMP can be from $1,000 to $10,000. There is no specifically defined
range of per-instance penalty for findings of immediate jeopardy. 42 C.F.R.

§ 488.438(a)(2). Thus, a finding of immediate jeopardy can have no effect on the range
of penalties. Nonetheless, CMS’s determination of immediate jeopardy in this case is an
17

appealable initial determination pursuant to section 498.3(b)(14)(ii), because the
deficiency cited resulted in a finding of substandard quality of care affecting the facility’s
NATCEP.

Immediate jeopardy is defined in the regulations as “a situation in which the provider’s
noncompliance with one or more requirements of participation has caused, or is likely to
cause, serious injury, harm, impairment, or death to a resident.” 42 C.F.R. § 488.301. In
any case where immediate jeopardy is at issue, CMS has the burden of coming forward
with sufficient prima facie evidence to show that immediate jeopardy was present. The
burden on a facility to disprove a determination of immediate jeopardy that is supported
by prima facie evidence is very heavy. A facility may overcome a prima facie case of
immediate jeopardy only by proving that CMS’s determination was clearly erroneous. 42
C.F.R. § 498.60(c)(2).

The evidence offered by CMS establishes a prima facie case that Petitioner’s
noncompliance, was at an immediate jeopardy level. Generally, to establish immediate
jeopardy it is not necessary to show that a resident or residents sustained serious injury,
harm, impairment, or died as a result of a deficiency. Immediate jeopardy exists also
where there is no proof that a deficiency has actually harmed a resident but where the
deficiency is /ikely to cause serious injury, harm, impairment, or death to a resident. 42
C.F.R. § 498.60(c)(2); Jnnsbruck HealthCare Center, DAB No. 1948 (2004). The
evidence in the case before me shows a likelihood of serious injury, harm, impairment, or
death to Resident 1 as a consequence of being entrapped. The risks of entrapment are
well known in the nursing home industry and the January 19, 2003 entrapment of
Resident 1 actually resulted in Resident 1’s death. The death certificate listed the cause
of death as asphyxiation-positional, extrinsic compression of the neck, and neck trapped
under the bed rail. CMS Ex. 13. Therefore, CMS’s determination that Petitioner’s
noncompliance was at the immediate jeopardy level is not clearly erroneous.

E. The amounts of the per-instance CMPs assessed against Petitioner
are reasonable.

CMS imposed a $1,000 per-instance CMP for the deficiency cited under 42 C.F.R. §
483.20(b) and a $3,050 per-instance CMP for the deficiency cited under 42 C.F.R. §
483.25(h)(2). I find that both of the per-instance CMPs imposed against Petitioner are
reasonable.

As noted above, a per-instance CMP can range from $1,000 to $10,000. In considering
whether the amount of the $3,050 CMP imposed by CMS is reasonable, I applied the four
factors listed in 42 C.F.R. § 488.438(f). The factors are: the facility’s history of
noncompliance; the facility’s financial condition; the factors specified in 42 C.F.R.
18

§ 488.404; and the facility’s degree of culpability which includes, but is not limited to,
neglect, indifference, or disregard for resident care, comfort, or safety. The factors to be
considered under 42 C.F.R. § 488.404 include the scope and severity of the deficiency
and the facility’s prior history of noncompliance with reference to the cited deficiency.

There is evidence that Petitioner’s financial condition is such that it could pay the total
per-instance CMP of $4,050. CMS presented evidence that Petitioner’s general balance
fund totaled $7,014,144. CMS Ex. 34, at 1. Petitioner’s Administrator Merle Taylor
testified that Petitioner was one of the largest employers in Jackson County, with an
annual budget of approximately seven million dollars. Tr. 141. Although, Mr. Taylor
stated that the facility was not profitable, Petitioner provided no evidence that paying a
total per-instance CMP of $4,050 would put it out of business. When considering the
reasonableness of a CMP, the relevant question is whether a CMP is so large that it would
put the facility out of business. Kelsey Memorial Hospital, DAB CR583 (1999).

The parties made no argument concerning Petitioner’s culpability or its prior enforcement
history. The scope and severity of the deficiency was an isolated incident, but at the
immediate jeopardy level. The facility ignored the need to apply measures.to prevent
entrapment in spite of the obvious risks posed in the case of Resident 1. Had CMS
chosen to impose a per day CMP, the minimum amount of per day CMP that could be
imposed for an immediate jeopardy deficiency is $3,050. Petitioner’s financial condition
and the scope and severity of the deficiency suggest that a per-instance CMP for the
deficiency cited under 42 C.F.R. § 483.25(h)(2) of $3,050 is reasonable. The per-instance
CMP for the deficiency cited under 42 C.F.R. § 483.20(b) is for the minimum amount of
$1,000 and is reasonable as a matter of law. I conclude that the combined per-instance
CMPs imposed against Petitioner are reasonable.

V. Conclusion

I sustain CMS’s determination to impose two per-instance CMPs totaling $4,050 against
Petitioner. I deny Petitioner’s motion for a directed finding in its favor.

/s/

Alfonso J. Montano
Administrative Law Judge