*This decision was originally issued as an “unpublished decision”
filed on November 17, 2003. On March 23, 2004, the court designated
the opinion as one recommended for full-text publication.
1
RECOMMENDED FOR FULL-TEXT PUBLICATION
Pursuant to Sixth Circuit Rule 206
ELECTRONIC CITATION: 2004 FED App. 0095P (6th Cir.)
File Name: 04a0095p.06
UNITED STATES COURT OF APPEALS
FOR THE SIXTH CIRCUIT
_________________
WOODSTOCK CARE CENTER,
Plaintiff-Petitioner,
v.
TOMMY THOMPSON,
SECRETARY, and UNITED
STATES DEPARTMENT OF
HEALTH AND HUMAN
SERVICES,
Defendants-Respondents.
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No. 01-3889
On Review of the Departmental Appeals Board of the
United States Department of Health and Human Services.
No. 00-00356—Walter H. Rice, District Judge.
Argued: May 8, 2003
Decided and Filed: November 17, 2003*
2 Woodstock Care Center v. Dept.
of Health and Human Serv.
No. 01-3889
**The Honorable Louis F. Oberdorfer, Senior United States District
Judge for the District of Columbia, sitting by designation.
1During the pend ency o f this action, HCFA was renamed the “Center
for Me dicare and Me dicaid Services.” For co nsistency, it will
nevertheless b e referred to as HCFA thro ughout.
Before: BOGGS, Chief Judge; BATCHELDER, Circuit
Judge; and OBERDORFER, Senior District Judge.**
_________________
COUNSEL
ARGUED: Geoffrey E. Webster, Columbus, Ohio, for
Petitioner. Sheila Ann Hegy, OFFICE OF THE CHIEF
COUNSEL, Chicago, Illinois, for Respondent. ON BRIEF:
Geoffrey E. Webster, Eric B. Hershberger, Columbus, Ohio,
for Petitioner. Sheila Ann Hegy, OFFICE OF THE CHIEF
COUNSEL, Chicago, Illinois, for Respondent.
_________________
OPINION
_________________
BOGGS, Chief Judge. Woodstock Care Center
(“Woodstock”), in an action against United States Department
of Health and Human Services (“HHS”) and Tommy
Thompson, in his capacity as Secretary of the HHS, seeks
review of a Civil Monetary Penalty (“CMP”) imposed against
Woodstock by the Health Care Financing Administration
(“HCFA”),1 an agency within HHS. A survey of Woodstock,
a long-term care facility for mentally disturbed residents
participating in the federal Medicare and Ohio Medicaid
programs, discovered numerous incidents in which residents
had been able to escape from the facility (referred to as
“elopement” by the parties) or to assault other residents.
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2In compliance with federal privacy regulations, all residents are
referred to exclusively by a number (“Resid ent N” or “RN”) in all public
court documents.
HCFA imposed the CMP under statutory and regulatory
authority requiring that facilities prevent accidents or risk of
accidents to residents. Woodstock appealed to an
Administrative Law Judge (“ALJ”) and the Departmental
Appeals Board (“DAB”) within HHS, both of which affirmed.
We affirm as well.
I
Woodstock is a long-term care skilled nursing facility
(“SNF”) in Ohio that participates in the federal Medicare and
the Ohio Medicaid programs. It houses forty-three residents,
half of whom were diagnosed with dementia and more than
two-thirds of whom displayed behavioral symptoms of
dementia. On February 17, 1998, inspectors of the Ohio
Department of Health, under delegated authority from HHS
to supervise facilities like Woodstock, and acting upon a
complaint by a Woodstock employee, launched a survey of
the facility, which concluded on March 4. The inspectors,
registered nurses with training and extensive experience in
such surveys, conducted four more visits to Woodstock, on
March 8, 11, and 15 and April 29. During their survey, they
noted the following incidents.
Resident 112 was admitted on September 29, 1997, and
suffered from organic brain disorder, ethanol alcohol
dependency, and seizures. R11 wore an electronic tracking
device, which triggered an alarm when the device passed
through any door to the outside world. On January 3, 1998,
R11 made his first attempt at elopement. He was discovered
missing at 11:25 p.m. and was returned eighty minutes later
after being found in a roadside ditch by a cornfield, two miles
away. In response, Woodstock installed a camera trained on
4 Woodstock Care Center v. Dept.
of Health and Human Serv.
No. 01-3889
the fence surrounding a patio area over which R11 was
assumed to have fled. On January 21, R11 was noted
attempting to climb the fence at 1 a.m., but he returned when
asked. At 2 a.m., he once again attempted to scale the fence
but failed. At 2:40 a.m., R11 called 911 and asked the police
to rescue him from Woodstock. At 4:45 a.m., he finally
managed to climb the fence and escape. At 5:30 a.m., he was
discovered by a Woodstock staff member wandering the
streets without shoes or coat, despite the low temperatures in
the January night, and was convinced to return. On February
17 or 19, Woodstock installed an alarm on the fence, but due
to lack of training of Woodstock’s staff, the alarm only
became operational on March 15.
R11 was also violent towards other inmates. Despite
having a known history of assault, he was assigned to share
a room with a 73-year old resident with organic brain
disorder. R11 assaulted his roommate on three occasions in
December 1997. The first assault resulted in a scalp
laceration that required stapling. A later assault included R11
pulling these staples. R11 also assaulted two other residents
while at Woodstock. In response, R11 received counseling
and had his medication altered, but without effect. R11
received his first psychological evaluation on March 2, 1998.
On March 7, he assaulted another resident.
Resident 3, a 81-year old woman suffering Alzheimer’s
disease and advancing dementia, was admitted on January 4,
1998. Prior to her admission, she had been a frequent visitor
to her husband, also a resident at Woodstock. On the day of
her admission, another visitor who remembered R3 as a
visitor held open the door for her, allowing her to escape.
While she was only able to walk with the aid of a walker, she
made it past a large, unfenced pond and rubble from a burned
building to a nearby busy street corner. She was found there
forty-five minutes later by Woodstock staff, who convinced
her to return.
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Resident 5, a 74-year old man suffering from Alzheimer’s
disease and dementia, was admitted on January 2, 1998. At
admission, he was heavily medicated and barely aware, or
“snowed.” Over the following months, Woodstock staff
experimented with altered dosage levels in order to allow him
to return to a more active mental state. However, whenever
dosage levels sank too low, R5 became highly agitated and
demanded to leave. On one occasion, on February 20, he
became “unsnowed” unexpectedly and managed to escape
through a long, unlocked window, opening to an unfenced
area, of the room in which Woodstock had placed him. He
was returned to Woodstock, displaying scratches, thirty
minutes later.
Resident 17, a 70-year old man diagnosed with
schizophrenia, dementia, and Parkinson’s disease, was
admitted on December 2, 1997. R17, who had a history of
verbal and physical aggression, delusions, combative
behavior, and refusal of care and medications, was on
medication for seizures, Parkinson’s disease, and
anxiety/agitation. While on medication, R17 suffered violent
mood swings between gentle states and extreme aggression.
While at Woodstock, he committed more than half a dozen
assaults against other residents. He attacked one resident four
times, causing hematoma on multiple occasions. The
assaulted resident also needed 35 sutures to close a head
wound caused by R17 breaking a chair on his head. R17 also
attacked several other residents. A total of 130 episodes of
R17's verbal and physical aggressiveness and combativeness
were recorded. Nevertheless, R17 received no psychological
or psychiatric care. On February 19, 1998, he committed
another assault and was found wearing a belt around his neck.
Woodstock discharged him to the Veterans Administration
the same day.
Based on these reports and memoranda submitted by the
inspectors and on their recommendation, HCFA concluded
that Woodstock had allowed conditions to persist that placed
6 Woodstock Care Center v. Dept.
of Health and Human Serv.
No. 01-3889
patients at risk and was therefore out of compliance with a
total of eighteen administrative requirements. While the
underlying incidents had largely occurred before the
beginning of the survey, HCFA found that the conditions that
allowed them to occur had existed at least from March 4,
when the survey concluded, through March 16, when
Woodstock took sufficient corrective measures. With respect
to the most serious administrative violation, deemed to be at
the level creating immediate jeopardy to the residents, HCFA
concluded that a sufficient remedy was in place on March 15.
HCFA assessed a CMP against Woodstock of $33,650:
$3,050 for each of the eleven days there was immediate
jeopardy to residents and $50 for each of the two remaining
days. HCFA also ordered additional monitoring of
Woodstock. However, HHS eventually rejected the
inspectors’ recommendations to terminate Woodstock’s
provider agreement.
On March 30, 1998, HCFA issued to Woodstock a Notice
of Imposition of Remedies. Woodstock requested a hearing,
under 42 C.F.R. § 498.40, in front of an HHS ALJ. At the
hearing, the three inspectors who had participated in the
survey and three of Woodstock’s employees testified. The
ALJ issued a decision in favor of HHS on all issues.
Woodstock appealed to the DAB, which affirmed the ALJ’s
decision in its entirety. Woodstock then filed a complaint
against HHS in the United States District Court for the
Southern District of Ohio. In it, Woodstock alleged that the
DAB’s decision was not supported by reliable, probative, and
substantial evidence, that the rationale supporting the decision
was arbitrary and capricious, that the decision was contrary to
42 C.F.R. § 482.25(h)(2), and that it violated Woodstock’s
“federal Constitutional due process rights.” The district court
concluded that the circuit courts of appeal have exclusive
jurisdiction over challenges to CMPs and therefore transferred
the case to us.
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II
Some issues, while prominent earlier in the litigation, need
not concern us here. There are no substantial disputes
remaining about the underlying facts. While the parties stress
different facts and slight discrepancies remain on issues such
as the exact length of certain elopements, the facts as stated
above are consistent with both accounts. Nor is there any
question regarding jurisdiction. The parties also agree on the
applicable standards of review. Woodstock has not appealed
the seventeen incidents of non-compliance at levels below
those presenting immediate jeopardy to residents, so we need
not consider the daily CMP of $50. The sole issue remaining
is whether the undisputed facts constituted, as a matter of law,
a violation of 42 C.F.R. § 483.25 that created immediate
jeopardy to the residents.
We have jurisdiction to review imposition of CMPs. “Any
person adversely affected by a determination of the Secretary
under this section may obtain a review of such determination
in the United States Court of Appeals for the circuit in which
the person resides.” 42 U.S.C. § 1320a-7a. “Upon such
filing, the court shall have jurisdiction of the proceeding and
of the question determined therein.” Ibid. Our standard of
review is highly deferential. “The findings of the Secretary
with respect to questions of fact, if supported by substantial
evidence on the record considered as a whole, shall be
conclusive.” 42 U.S.C. § 1320a-7a. “In reviewing the
Secretary [of HHS]’s interpretation of regulations, courts may
overturn the Secretary’s decision only if it is ‘arbitrary,
capricious, an abuse of discretion or otherwise not in
accordance with the law.’” St. Francis Health Care Ctr. v.
Shalala, 205 F.3d 937, 943 (6th Cir. 2000) (quoting Thomas
Jefferson Univ. v. Shalala, 512 U.S. 504, 512 (1994)).
“Further, courts are to ‘give substantial deference to an
agency’s interpretation of its own regulations.’” St. Francis,
205 F.3d at 943 (quoting Thomas Jefferson Univ., 512 U.S. at
512). “In sum, if ‘it is a reasonable regulatory interpretation
8 Woodstock Care Center v. Dept.
of Health and Human Serv.
No. 01-3889
we must defer to it.’” St. Francis, 205 F.3d at 944 (quoting
Shalala v. Guernsey Memorial Hosp., 514 U.S. 87, 94-95
(1995)) (internal alterations omitted).
Federal regulations impose significant requirements on
SNFs, such as Woodstock, that participate in the federal
Medicare and state Medicaid schemes. “Each resident must
receive and the facility must provide the necessary care and
services to attain or maintain the highest practicable physical,
mental, and psychosocial well-being, in accordance with the
comprehensive assessment and plan of care.” 42 C.F.R.
§ 483.25. “The facility must ensure that . . . [e]ach resident
receives adequate supervision and assistance devices to
prevent accidents.” 42 C.F.R. § 483.25(h)(2). “Deficiency
means a [facility’s] failure to meet a participation requirement
specified in the Act or in [42 C.F.R. §§ 483.1-80].” 42 C.F.R.
§ 488.301. “Substandard quality of care means one or more
deficiencies related to participation requirements under . . .
§ 483.25, . . . which constitute either immediate jeopardy to
resident health or safety; a pattern of or widespread actual
harm that is not immediate jeopardy; or a widespread
potential for more than minimal harm, but less than
immediate jeopardy, with no actual harm.” 42 C.F.R.
§ 488.301. “Immediate jeopardy means a situation in which
the provider’s noncompliance with one or more requirements
of participation has caused, or is likely to cause, serious
injury, harm, impairment, or death to a resident.” 42 C.F.R.
§ 488.301.
HHS is authorized to impose a CMP on a SNF that is out of
compliance with § 483.25. “The Secretary may impose a
civil money penalty in an amount not to exceed $10,000 for
each day of noncompliance.” 42 U.S.C. § 1395i-
3(h)(2)(B)(ii). “Penalties in the range of $3,050-$10,000 per
day are imposed for deficiencies constituting immediate
jeopardy.” 42 C.F.R. § 488.438(a)(1)(I). “The per day
[CMP] may start accruing as early as the date that the facility
was first out of compliance, as determined by [HHS] or the
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State.” 42 C.F.R. §488.440(a)(1). “The per day [CMP] is
computed . . . for the number of days of noncompliance until
the date the facility achieves substantial compliance, as
determined by [HHS] or the State.” 42 C.F.R. § 488.440(b).
In the current case, HHS concluded that Woodstock had
failed to “ensure that . . . [e]ach resident receives adequate
supervision and assistance devices to prevent accidents.” 42
C.F.R. § 483.25(h)(2). In particular, HHS found that
Woodstock had not taken the relevant security precautions,
such as closer supervision of residents known to be violent or
flight risks, including physical restraint where necessary,
better psychological and psychiatric counseling and
medication of such residents, and more effective perimeter
security. This failure resulted in immediate jeopardy to
residents. In particular, eloping residents suffered minor
injuries during their escapes and suffered the risk of more
serious injuries. Aggressive residents inflicted serious
injuries on other residents. Next, HHS concluded that the
conditions that allowed such incidents to occur existed from
at least March 4 through March 14. For each of these eleven
days that the conditions were known to exist, HHS imposed
the minimum daily CMP for conditions creating immediate
jeopardy to residents, $3,050. The ALJ and the DAB
affirmed this judgment.
Woodstock contends that § 483.25(h)(2) is not applicable
to the incidents listed because none of them were “accidents.”
Rather, Woodstock argues, the elopements and assaults were
intentional acts by the residents and intentional acts cannot be
characterized as accidents. The ALJ rejected this argument
by pointing out that the assaults were not intentional on part
of the victims and therefore may be regarded as accidents.
However, we need not rule on the validity of this contention,
which could render practically every assault or murder an
accident, because, as the DAB recognized, the legal issue here
is whether Woodstock “ensure[d] that . . . [e]ach resident
receive[d] adequate supervision and assistance devices to
10 Woodstock Care Center v. Dept.
of Health and Human Serv.
No. 01-3889
prevent accidents.” 42 C.F.R. § 483.25(h)(2). The cited
incidents, regardless of whether they were accidents or not,
constitute valid probative evidence as to whether Woodstock
adequately supervised the residents. A resident so ill-
supervised that he has the opportunity to assault other
residents repeatedly and severely may well also be
inadequately supervised to prevent accidents. More
significantly, a resident who has eloped and wanders an
environment dangerous to him or her is completely without
any supervision. Again, this is so regardless of whether the
elopement itself can legally be characterized as an accident.
Woodstock also contends that HHS, in imposing a CMP,
held it to a strict liability standard and, under any standard of
reasonable care, it had not acted wrongly. Woodstock
contends that the attacks and elopements were unprovoked
and unpredictable and could not have been prevented.
However, the ALJ and the DAB explicitly held that the
standard Woodstock faced was not a strict liability standard.
Rather, they found that Woodstock had failed to take all
reasonable precautions against residents’ accidents. The
question whether Woodstock took all reasonable precautions
is highly fact-bound and can only be answered on the basis of
expertise in nursing home management. As such, it is a
question the resolution of which we defer to the expert
administrative agency, the HHS. But even from our inexpert
perspective, numerous actions undertaken by Woodstock
would appear to be negligent. For example, allowing R11 to
continue to share a room with a helpless resident whom he
had already several times severely assaulted seems to border
on recklessness. So does failing to restrain R11 after several
escape attempts in one night until he finally succeeded, as
well as keeping R5 in a room with a large, unlocked window,
despite the fact that he was known to be an escape risk. On
this basis, we uphold HHS’s finding that Woodstock failed to
meet the requisite standard of care.
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Woodstock argues that at common law there was no
presumption of negligence against nursing homes whose
residents escape and nursing homes were not the insurers of
the safety of their patients but needed only exercise
reasonable care. This is only marginally relevant. In the
current case, Woodstock was not sued in tort by an injured
resident. Instead, Woodstock suffered an administrative
penalty under regulations to which it consented when it was
permitted to participate in the Medicare and Medicaid
programs. These regulations can and do set a higher standard
than the common law.
Finally, Woodstock argues that the eloping residents were
not in immediate jeopardy and that the elopements therefore
were not a valid basis for imposition of CMPs at the increased
level. “Immediate jeopardy means a situation in which the
provider’s noncompliance with one or more requirements of
participation has caused, or is likely to cause, serious injury,
harm, impairment, or death to a resident.” 42 C.F.R.
§ 488.301 (emphasis added). The only actual injuries in the
record caused by the elopements were the scratches suffered
by R5 and the possible aggravation of pneumonia suffered by
R11 during the hours he spent outside during a January night
without shoes or coat. The former was not a serious injury
and the latter, speculation. Nevertheless, we uphold the HHS
finding of immediate jeopardy. Given the number of
elopements at Woodstock over the course of a few months,
the vulnerable state of the residents, and the dangers of the
outside world to residents in such a state, the conclusion that,
earlier or later, the elopements would likely cause serious
injury was supported by substantial evidence. Even in the
absence of “actual harm,” a “widespread potential for more
than minimal harm” is sufficient to sustain the CMP.
42 C.F.R. § 488.301.
12 Woodstock Care Center v. Dept.
of Health and Human Serv.
No. 01-3889
III
For these reasons, we AFFIRM the Department of Health
and Human Service’s imposition of civil monetary penalties.
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