                        NOT RECOMMENDED FOR PUBLICATION
                               File Name: 05a0662n.06
                                Filed: August 4, 2005

                                         No. 04-3949

                          UNITED STATES COURT OF APPEALS
                               FOR THE SIXTH CIRCUIT

CLERMONT NURSING AND                        )
CONVALESCENT CENTER,                        )
                                            )
       Petitioner,                          )
                                            )     ON PETITION FOR REVIEW OF THE
v.                                          )     FINAL DECISION OF THE SECRETARY
                                            )     OF HEALTH AND HUMAN SERVICES
MICHAEL O. LEAVITT et al.,                  )
                                            )     OPINION
                                            )
       Respondents.                         )
                                            )



Before: CLAY, GILMAN, and COOK, Circuit Judges.

       RONALD LEE GILMAN, Circuit Judge. Clermont Nursing and Convalescent Center

appeals from the imposition by the Secretary of Health and Human Services, operating through the

Centers for Medicare & Medicaid Services, of a civil monetary penalty imposed upon Clermont for

noncompliance with federal regulations. For the reasons set forth below, we DENY review of the

decision by the Health & Human Services’s Departmental Appeals Board (DAB).


                                     I. BACKGROUND

A.     Factual background

       Clermont is a nursing home located in Milford, Ohio. As a participant in the federal

government’s Medicare & Medicaid programs, Clermont is required by law to comply with all

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federal regulations for nursing homes participating in these programs. On September 3, 1999, the

Ohio Department of Health, acting by agreement with the United States Secretary of Health and

Human Services (the Secretary), conducted a survey of the facility. This survey found that Clermont

was not in compliance with 23 federal regulations for nursing homes participating in the Medicare

and Medicaid programs. Of these 23 alleged instances of noncompliance, 2 are at issue in this

appeal.

          The first point of contention involves the surveyors’ finding that Clermont was not in

compliance with 42 C.F.R. § 483.25(c), which mandates that a facility ensure that a “resident who

enters the facility without pressure sores does not develop pressure sores unless the individual’s

clinical condition demonstrates that they were unavoidable.” The regulation further requires that

a facility ensure that “[a] resident having pressure sores receives necessary treatment and services

to promote healing, prevent infection and prevent new sores from developing.” Id. A pressure sore

is defined as “[d]amage to the skin or underlying structure as a result of tissue compression and

inadequate perfusion.” Taber’s Cyclopedic Medical Dictionary 1675 (19th ed. 2001). They

“typically occur in patients who are bed or chair bound.” Id.

          Clermont was fined on the basis of pressure sores that were found on five residents, referred

to as Residents 43, 50, 72, 168, and 171. (Residents are assigned numbers by the Department of

Health and Human Services to protect their identities.) The factual circumstances regarding these

five residents are thoroughly discussed in the DAB’s opinion. A detailed explanation by us of each

resident’s condition would therefore be repetitive.




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       The second point of contention involves the surveyors’ finding that Clermont was not in

compliance with 42 C.F.R. § 483.25(h)(2), which requires that a facility ensure that “[e]ach resident

receives adequate supervision and assistance devices to prevent accidents.” Clermont was fined in

this regard for the treatment of Residents 6, 14, 72, 147, and 163. Again, because the DAB has

exhaustively described the circumstances in which each resident was observed, a factual exposition

by us would be unduly repetitive.

B.     Procedural background

       Based upon the deficiencies found by the Ohio Department of Health, the Centers for

Medicare & Medicaid Services fined Clermont $651 per day for 51 days, beginning on September

3, 1999 and lasting through October 23, 1999. The total fine imposed on Clermont was $33,150.

       Clermont responded by requesting a hearing before an administrative law judge (ALJ)

pursuant to 42 C.F.R. § 488.408(g)(1). The ALJ concluded that two of the cited deficiencies—the

noncompliance     with   pressure-sore    treatment    and   the   noncompliance     with   accident

prevention—provided a sufficient basis for the fine imposed by the Centers for Medicare &

Medicaid Services. He therefore declined to address the remaining 21 deficiencies.

       Clermont subsequently appealed the decision by the ALJ to the DAB pursuant to 42 C.F.R.

§ 498.80. A three-member panel of the DAB affirmed the decision by the ALJ. Clermont filed a

timely petition for review.


                                         II. ANALYSIS

A.     Standard of review



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       The Secretary’s decision to impose a fine on a nursing home, “if supported by

substantial evidence on the record considered as a whole, shall be conclusive.” 42 U.S.C. § 1320a-

7a(e); see also Woodstock Care Ctr. v. Thompson, 363 F.3d 583, 588 (6th Cir. 2003) (noting that,

when reviewing such fines, “[o]ur standard of review is highly deferential”). “Substantial evidence

is defined as such relevant evidence as a reasonable mind might accept as adequate to support a

conclusion. In our review, we do not consider the case de novo, nor resolve conflicts in the

evidence, nor decide questions of credibility.” Myers v. Sec’y of Health & Human Servs., 893 F.2d

840, 842 (6th Cir. 1990) (citations and quotation marks omitted). In addition, the question of

whether the defendant in question took all reasonable precautions to prevent accidents 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

[Department of Health and Human Services].” Woodstock Care Ctr., 363 F.3d at 589.

B.     The appropriate legal standard

       Clermont’s primary argument is that both the ALJ and the DAB applied the incorrect legal

standard when assessing whether Clermont was in compliance with 42 C.F.R. §§ 483.25(c) and

483.25(h)(2). It contends that it was held to a strict-liability standard by the Department of Health

and Human Services, and that this standard was an erroneous interpretation of the reasonableness

standard required by the regulations.

       With regard to 42 C.F.R. § 483.25(c)—the regulation governing pressure-sore

development—Clermont contends that it was held to a strict-liability standard by the ALJ when he

commented that

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        a participating facility is required to go beyond merely doing what seems reasonable
        to prevent and treat pressure sores and, instead, must always furnish what is
        necessary to prevent new pressure sores from developing or existing pressure sores
        from becoming worse, unless the development of new sores or aggravation of
        existing sores is clinically unavoidable.

Clermont contends that the ALJ’s conclusion that a facility “is required to go beyond merely doing

what seems reasonable to prevent and treat pressure sores” exceeds Clermont’s obligations under

the federal regulations.

        As the DAB observed, however, 42 C.F.R. § 483.25(c)(2) requires a facility to “ensure that

[a] resident having pressure sores receives necessary treatment and services to promote healing,

prevent infection and prevent new sores from developing.” Id. (emphasis added). The ALJ’s

observation that a facility must furnish what is necessary to prevent and treat existing pressure sores,

and the DAB’s concurrence, therefore appears to us to be consistent with the requirements of 42

C.F.R. § 483.25(c).

        In addition, we find nothing in the record to suggest that Clermont was held to a strict-

liability standard by the DAB. The instances cited by the surveyors were ones in which the

appropriate treatment was not being provided to residents suffering from pressure sores. For

example, officials observed that Resident 50, who was suffering from several existing pressure

sores, was restrained in his wheelchair for extended periods of time without any protective padding.

They also observed Resident 50 lying in his bed wearing urine-soaked briefs for approximately two

hours. When Clermont’s staff came to provide incontinent care, the surveyors noted that urine was

contaminating the pressure sore. These and other observations support the finding that Clermont




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had failed to “ensure that [a] resident having pressure sores receives necessary treatment to promote

healing, prevent infection and prevent new sores from developing.” 42 C.F.R. § 483.25(c)(2).

        Clermont further maintains that the ALJ and the DAB misconstrued the correct legal

standard with regard to 42 C.F.R. § 483.25(h)(2), the regulation calling for the prevention of

foreseeable accidents. Specifically, Clermont claims that it was held to a strict-liability standard

because the ALJ failed to draw any causal links between the accidents that occurred and Clermont’s

alleged noncompliance.

        Clermont’s argument, however, is belied by the detailed opinion of the DAB. In that

opinion, the DAB correctly notes that the key requirement is that “the facility must eliminate or

reduce the risk of accident to the greatest degree practicable.” (Emphasis in original.) It further

observed that, “[a]s a risk-oriented analysis, this does not require that either an accident or resident

injury actually occur for a violation to exist.” The DAB concluded that this eliminates the need “to

establish accident causation in determining whether there was a lack of substantial compliance with

this requirement.” Its analysis in this case is also consistent with its prior opinions. See Omni

Manor Nursing Home, D.A.B. No. 1920, at 38-39 (2004); Woodstock Care Ctr., D.A.B. No. 1726,

at 17 (2000).

        In addition, the DAB specifically looked at whether each resident had received adequate

supervision or assistance. Nothing in the record suggests that the ALJ or the DAB took a

“hindsight” approach. For example, the surveyors saw Resident 72 lying in a bed with a waist

restraint. The waist restraint was improperly affixed because it was attached to a nonmovable part

of the bed frame and because it was wrapped around her chest. This could have led the resident to

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seriously injure herself. Such observations support the DAB’s finding that Cermont was in violation

of 42 C.F.R. § 483.25(h)(2), which requires that a facility ensure that “[e]ach resident receives

adequate supervision and assistance devices to prevent accidents.”

C.     Substantial evidence

       Clermont’s remaining argument is that the decision by the DAB is not supported by

substantial evidence. It proceeds on a resident-by-resident basis to contend that the DAB

misconstrued or overlooked key facts in examining the record.

       We believe that revisiting the factual circumstances and medical histories of each resident

would be unduly duplicative. The record contains numerous facts with regard to each resident that

buttress the DAB’s decision, and Clermont’s arguments to the contrary are unpersuasive. We

therefore conclude that the decision by the DAB is supported by substantial evidence.


                                      III. CONCLUSION

       For all of the reasons set forth above, we DENY review of the decision by the DAB.




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