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CASE | DECISION | ANALYSIS | JUDGE | FOOTNOTES

Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Appellate Division
IN THE CASE OF  


SUBJECT: Batavia Nursing and Convalescent Center,

Petitioner,

DATE: January 14, 2004

             - v -
 

Centers for Medicare & Medicaid Services.

 

Docket No. A-03-75
Civil Remedies CR1031
Decision No. 1904
DECISION
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FINAL DECISION ON REVIEW OF
ADMINISTRATIVE LAW JUDGE D
ECISION

Batavia Nursing and Convalescent Center (Batavia or Petitioner) appealed an April 16, 2003 decision by Administrative Law Judge (ALJ) Richard J. Smith affirming the determination by the Centers for Medicare & Medicaid Services (CMS) (1) to impose a $600 per day civil money penalty (CMP) against Batavia for failure to comply substantially with certain Medicare participation requirements. Batavia Nursing and Convalescent Center, DAB CR1031 (2003)(ALJ Decision). The CMP upheld by the ALJ totalled $33,600 ($600 per day from August 6, 1999 through September 30, 1999). ALJ Decision at 2.

We find that the ALJ's findings are supported by substantial evidence in the record as a whole and that there are no errors in his conclusions of law. We thus affirm the ALJ Decision in its entirety and sustain the CMP of $33,600.

Background

Legal Background

Batavia is a skilled nursing facility that participates in the Medicare program. Medicare participation requirements are set forth in 42 C.F.R. Part 483. Compliance with these requirements is verified through a survey and certification process set forth in 42 C.F.R. Part 488, Subpart E. Compliance surveys are generally conducted by a state agency under agreement with CMS. Survey findings are presented in a Statement of Deficiencies (CMS 2567), (2) which identifies and discusses each alleged failure by the facility to meet a participation requirement. See CMS State Operations Manual (SOM) Appendix P, IV. (3) Deficiency findings are identified in the CMS 2567 using data "tags" corresponding to the requirements of participation in 42 C.F.R. Part 483. Id.; SOM Appendix PP.

If a survey reveals that a facility is not in "substantial compliance" with a participation requirement, the facility must submit a Plan of Correction (POC) (4) for the cited deficiencies for approval by the survey agency. 42 C.F.R. 488.402(d), 488.408(f). Even if the state agency approves the POC, the facility may not be regarded as in substantial compliance until the survey agency determines, following an onsite revisit or other means of verification, that the deficiency no longer exists. 42 C.F.R. 488.440(h); SOM 7316. "Substantial compliance" is defined as "a level of compliance with the requirements of participation such that any identified deficiencies pose no greater risk to resident health or safety than the potential for causing minimal harm." 42 C.F.R. 488.301.

CMS enforces participation requirements, in part, by imposing remedies for a facility's failure to maintain compliance. (5) See 42 C.F.R. Part 488, Subpart F. CMS selects the appropriate remedy, if any, based on the "seriousness of the deficiencies." 42 C.F.R. 488.404(a). (6) Deficiencies are categorized by letters A-L, which is a function of their "seriousness" (severity and scope). 42 C.F.R. 488.408; SOM 7400E.1; SOM Appendix P, V.; CMS Ex. 12 at 1. A Level G deficiency is an isolated instance of noncompliance that causes actual harm, but does not pose immediate jeopardy to the resident. SOM 7400E.1 (deficiency grid). For a Level G deficiency, CMS may impose a CMP in the range of $50-$3,000 per day. 42 C.F.R. 488.438(a)(1)(ii); SOM 7400F.2 (Category 2 remedies). In determining the choice of a remedy within a remedy category, CMS may consider factors that include, without limitation, "the relationship of the one deficiency to other deficiencies resulting in noncompliance" and "the facility's prior history of noncompliance in general and specifically with reference to the cited deficiencies." 42 C.F.R. 488.404(c).

The amount of the CMP is determined by the facility's history of noncompliance (including repeat deficiencies), its financial condition, the factors set forth in 42 C.F.R. 488.404, and the facility's degree of culpability. 42 C.F.R. 488.438(f). (7) The CMP accrues until either "(1) The facility has achieved substantial compliance, as determined by [CMS] or the State based upon a revisit or after an examination of credible written evidence that it can verify without an on-site visit" or "(2) [CMS] or the State terminates the provider agreement." 42 C.F.R. 488.454(a).

When an ALJ determines that CMS had a basis for imposing a CMP, the ALJ may not review CMS's exercise of discretion in selecting the CMP as a remedy. 42 C.F.R. 488.438(e)(2). A facility may, however, appeal the state survey agency's certification of noncompliance which leads to the selection of a CMP. 42 C.F.R. 488.408(g). These appeals are governed by regulations set forth in 42 C.F.R. Part 498. 42 C.F.R. 498.3(a)(3)(ii).

The Surveys

The following summary of background information is drawn from the ALJ Decision and the record before the ALJ. It is intended to provide a general framework for understanding the ALJ Decision and is not a substitute for the ALJ's findings.

The Ohio Department of Health (ODH) performed a standard survey at Batavia from August 2 to August 6, 1999 (standard survey). CMS Ex. 1, at 1. As a result, ODH cited Batavia for multiple deficiencies, the most serious being four F-Tags found at Level G: F-157 (physician notification of changes); F-309 (quality of care); F-314 (pressure sores); and F-324 (accident prevention). ODH also cited Batavia for nine Level D deficiencies and one Level E deficiency. CMS Ex. 4. On August 5, 1999, ODH also conducted a "life safety code standard" inspection, resulting in one F-level citation under tag K-046 (emergency lighting). CMS Ex. 5.

On August 13, 1999, ODH advised Batavia that if it had not achieved substantial compliance by September 25, 1999, ODH would recommend certain remedies, including a CMP of $600 per day (effective August 6, 1999). CMS Ex. 12. Batavia submitted a POC on August 27, 1999, which stated that Batavia would achieve substantial compliance with the requirements by September 20, 1999. CMS Ex. 4; see also SOM 7317A (POC as allegation of compliance).

On September 29, 1999, ODH conducted a revisit survey (revisit survey). CMS Ex. 15. As a result, Batavia was cited with four deficiencies, the most serious being one F-Tag found at Level G: F-324 (accident prevention). This deficiency had also been cited during the standard survey. ODH also cited Batavia for three Level D deficiencies and again recommended that CMS impose remedies that included a CMP of $600 per day (effective August 6, 1999). CMS Ex. 16. Batavia submitted a POC on October 15, 1999, alleging substantial compliance as of October 1, 1999. CMS Ex. 15.

ODH conducted a follow-up survey on October 21, 1999 and verified Batavia's allegations of substantial compliance, effective October 1, 1999. CMS Ex. 22. On November 23, 1999, CMS imposed a CMP of $33,600 ($600 daily, from August 6, 1999 through September 30, 1999). CMS Ex. 24, at 2.

The ALJ Decision

In December 1999, Batavia requested an ALJ hearing, disputing ODH's determination that Batavia had not been in substantial compliance with program requirements and the imposition of a CMP. Specifically, Batavia excepted to the factual basis of each deficiency cited in the standard and revisit surveys. An evidentiary hearing before ALJ Smith was held on January 15-17, 2002. ALJ Decision at 2.

The ALJ Decision contains six numbered Findings of Fact and Conclusions of Law (FFCL), one FFCL for each of the five Level G deficiencies cited by ODH during the standard and revisit surveys and one FFCL concerning the reasonableness of the CMP. ALJ Decision at 4, 6, 10, 12, 20, 24. The ALJ Decision states that it addresses only the Level G deficiencies, as they alone were sufficient to uphold the CMP imposed by CMS. ALJ Decision at 4.

In FFCL 1, the ALJ found that Batavia failed to notify the physicians of Residents 102 and 2 of significant changes in the residents' conditions, as required by 42 C.F.R. 483.10(b)(11) (F-Tag 157). ALJ Decision at 4-6. In FFCL 2, the ALJ found that Batavia failed to provide the care and services necessary to Residents 154, 186, and 39 in order that they could attain or maintain their highest practicable physical, mental, and psychosocial wellbeing, in accordance with a comprehensive assessment and plan of care and as required by 42 C.F.R. 483.25 (F-Tag 309). ALJ Decision at 6-10. In FFCL 3, the ALJ found that Batavia failed to ensure that Resident 169 received necessary treatment and services to promote healing and prevent infection of an existing pressure sore, as required by 42 C.F.R. 483.25(c) (F-Tag 314). ALJ Decision at 10-12. In FFCL 4, the ALJ found that Batavia failed to provide adequate supervision and assistance devices to Residents 39, 164, 7, and 41 to prevent accidents, as required by 42 C.F.R. 483.25(h)(2) (F-Tag 324). ALJ Decision at 12-20. In FFCL 5, the ALJ found that as of the revisit survey, Batavia failed to provide adequate supervision and assistance devices to Residents 61, 81, and 161 to prevent accidents, as required by 42 C.F.R. 483.25(h)(2) (F-Tag 324). ALJ Decision at 20-23. In FFCL 6, the ALJ found that the amount of the CMP imposed by CMS was reasonable. ALJ Decision at 24.

Issues

Batavia's request for review and supporting brief (Request for Review or RR) (8) raises numerous legal and factual issues. Batavia argued that allocating the burden of proof to Batavia by a preponderance of the evidence, under Hillman Rehabilitation Center, DAB No. 1611 (1997), aff'd Hillman Rehabilitation Center v. United States, No. 98-3789 (GEB)(D.N.J. May 13, 1999) (hereinafter, "Hillman"), conflicts with the Administrative Procedure Act (APA) and cited case law. RR at 3. Batavia also argued that the Hillman standard should have been promulgated pursuant to rulemaking procedures set forth in the APA and that section 205(a) of the Social Security Act also required publication of a rule on burden of proof. RR at 5. In addition, Batavia maintained that it had prevailed on all non-Level G deficiencies not addressed in the ALJ Decision. RR at 6. Finally, Batavia excepted to each of the six FFCLs made by the ALJ. RR at 7-18.

Standard of Review

The standard of review on a disputed conclusion of law is whether the decision is erroneous. The standard of review on a disputed finding of fact is whether the ALJ's finding is supported by substantial evidence in the record. Guidelines -- Appellate Review of Decisions of Administrative Law Judges Affecting a Provider's Participation in the Medicare and Medicaid Programs (Guidelines), 4(b), (at http://www.hhs.gov/ dab/guidelines/prov.html); South Valley Health Care Center, DAB No. 1691 (1999), aff'd South Valley Health Care Center v. HCFA, 223 F.3d 1221 (10th Cir. 2000).

Substantial evidence is "more than a mere scintilla. It means such relevant evidence as a reasonable mind might accept as adequate to support a conclusion." Richardson v. Perales, 402 U.S. 389, 401 (1971), quoting Consolidated Edison Co. v. NLRB, 305 U.S. 197, 229 (1938). Under the substantial evidence standard, the reviewer must examine the record as a whole and take into account whatever in the record fairly detracts from the weight of the decision below. Universal Camera Corp. v. NLRB, 340 U.S. 474, 488 (1951). The reviewer does not, however, reweigh the evidence nor substitute his or her judgment for that of the initial decision-maker. Casias v. Secretary of Health & Human Services, 933 F.2d 799, 800 (10th Cir. 1991). Thus, the reviewer must not displace a "choice between two fairly conflicting views," even though a different choice could justifiably have been made if the matter had been before the reviewer de novo. Universal Camera, 340 U.S. at 488. The reviewer must, however, set aside the initial conclusions when he or she "cannot conscientiously find that the evidence supporting that decision is substantial, when viewed in the light that the record in its entirety furnishes, including the body of evidence opposed to the [initial decision-maker's] view." Id. In addition, the Board has held that an ALJ need not "cite to everything in the record which supports" the findings, but that the "evidence that the ALJ does cite must support the findings made." Reconsideration of Wesley Hal Livingston and Shoals Medical Equipment and Supply Co., Inc., DAB No. 1406, at 3 (1993).

ANALYSIS
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Below, we first discuss whether the Board's holding in Hillman is a substantive rule requiring notice and comment rulemaking under the APA. We then discuss whether the absence of a regulation specifying the burden of proof in this administrative proceeding violates section 205(a) of the Social Security Act (Act). Next, we discuss whether allocating to Batavia the ultimate burden of persuasion on the issue of substantial compliance conflicts with the APA or cited case law. We then discuss whether Batavia prevails on non-Level G deficiencies. We continue by discussing whether substantial evidence and applicable law supports the ALJ's determinations in FFCLs 1-5 and whether the amount of the CMP is reasonable.

The Board's conclusion in Hillman regarding ultimate burden of persuasion is not a rule requiring notice and comment rulemaking pursuant to the APA.

Batavia argued that the "Hillman standard" is a rule that should have been promulgated pursuant to notice and comment rulemaking provisions under section 553 of the APA, rather than determined through "mere adjudication." RR at 5-6, citing 5 U.S.C. 553 (b),(c). (9)

Administrative agencies establish governing standards through formal notice and comment rulemaking or through adjudication, absent limited exceptions not applicable here. 5 U.S.C. 553, 554. Adjudication is the "agency process for the formulation of an order," 5 U.S.C. 551(7), and applies in cases "required by statute to be determined on the record after opportunity for an agency hearing . . . ." 5 U.S.C. 554(a). An order is "the whole or part of a final disposition, whether affirmative, negative, injunctive, or declaratory in form, of an agency in a matter other than rule making . . . ." 5 U.S.C. 551(6) (emphasis added). (10) The Supreme Court has long acknowledged that the "the choice made between proceeding by general rule or by individual, ad hoc litigation is one that lies primarily in the informed discretion of the administrative agency." SEC v. Chenery, 332 U.S. 194, 203 (1947), citing Columbia Broadcasting System v. U.S., 316 U.S. 407, 421 (1942)(parallel citations omitted); Bell Aerospace, 416 U.S. at 293.

Cases involving the termination of a provider agreement, as in Hillman, must be adjudicated in hearings on the record pursuant to section 205(b) of the Act. See section 1866(h)(1) of the Act. Since the agency process by which the Hillman decision was issued was conducted pursuant to a statutory requirement for a hearing on the record, it was an "adjudication" under the APA. The regulations that establish procedures for hearings on termination of provider agreements, and for other appealable initial determinations related to participation in Medicare, are at 42 C.F.R. Part 498. These regulations do not specify who bears the burden of proof in each of the different types of cases.

In Hillman, CMS took exception to the legal conclusion reached by the ALJ who conducted the hearing that "[CMS] has the burden of proving that Petitioner failed to comply with a condition of participation in Medicare." The Board concluded that the ALJ erred in determining that CMS had the burden of proof (in the sense of the ultimate burden of persuasion), reversed the ALJ's conclusion, and substituted the following:

FFCL 1A. [CMS] must set forth the basis for its determination terminating a provider with sufficient specificity for the provider to respond, including the basis for any finding that a condition-level deficiency exists. The provider must then identify which of the findings material to the determination the provider disputes, and must also identify any additional facts the provider is asserting.

FFCL 1B. At the hearing, [CMS] has the burden of coming forward with evidence related to disputed findings that is sufficient (together with any undisputed findings and relevant legal authority) to establish a prima facie case that CMS had a legally sufficient basis for termination.

FFCL 1C. At the hearing, the provider has the burden of coming forward with evidence sufficient to establish the elements of any affirmative argument or defense which it offers.

FFCL 1D. The provider bears the ultimate burden of persuasion. To prevail, the provider must prove by a preponderance of the evidence on the record as a whole that it is in substantial compliance with the relevant statutory and regulatory provisions.

The major reasons for these conclusions of law were as follows:

The rationale for the ALJ's conclusion regarding burden of proof failed to distinguish clearly the burden of going forward from the ultimate burden of persuasion, and misconstrued the effect of requiring CMS to make a prima facie case.

Congress authorized payments to be made to providers such as rehabilitation agencies only if they qualified--not only by filing a provider agreement, but also by meeting applicable conditions of participation, as shown by an affirmative determination of compliance, generally made by CMS on the basis of state survey agency findings. A mere determination on appeal that it is only "as likely" that the conditions were substantially met as that they were not met could result in payment contrary to statutory intent. The purpose of the conditions--to protect the health and safety of the patients who are the intended beneficiaries of the program--requires that an affirmative determination of substantial compliance be made.

Contrary to what the ALJ found, there is no distinction, relevant for who bears the burden of proof, between a provider first seeking to participate in the program and a provider whose agreement is terminated. The provider agreement is not a contract which should be presumed to continue in effect unless CMS can prove at a hearing that its terms were violated. The provider's obligation to meet the conditions of participation in order to qualify for payment does not arise from the agreement, but from the statute. While CMS must make a determination consistent with the statutory and regulatory requirements for termination of a provider agreement, that determination alone is a basis for termination, effective on the date set by CMS in the notice of its determination. In any event, a provider agreement by itself is not sufficient to show that payment under the statute is authorized. Under the regulations, a finding of noncompliance supersedes any previous certification.

The ALJ's allocation of the burden of proof was inconsistent with the relevant case precedent and relied on analogies to types of cases that are inapposite.

Nothing in the due process cases on which Hillman relied requires that CMS bear the burden of persuasion. Contrary to what Hillman implied, the courts have not found any provider expectation of continued participation that outweighs CMS's interest in protecting the patients and program. At most, they have held that a provider has a right to reasonable notice and an opportunity for a hearing, which in most cases can be satisfied by a post-termination hearing or an informal pretermination hearing followed by a post-termination evidentiary hearing.

The underlying concerns about fairness to the provider, reflected in the ALJ analysis, can be met without placing the ultimate burden of persuasion on CMS.

In deciding who has the burden of proof, it is traditional (and based on fundamental fairness) to consider who has knowledge of the facts involved. Any evidence which CMS had gathered came from a survey of the provider's own records and facilities, and the provider is the one in possession of the most complete evidence of the state of its compliance. Thus, the Board noted: "While it is fair to require CMS to come forward with the evidence of noncompliance which CMS has obtained from the provider, it is unfair under the circumstances to place the ultimate burden of persuasion on CMS."

The provider in Hillman appealed, challenging the Board's legal conclusions on burden of proof, and the court upheld the conclusions. Hillman Rehabilitation Center v. United States, No. 98-3789 (GEB) (D.N.J. May 13, 1999).

The Board and ALJs have cited the Hillman decision as precedent when discussing burden of proof, and sometimes have used terms such as "standard" or "rule" as shorthand for the legal conclusions in that decision; use of such terms does not change the nature of the conclusions, however. If the Board were persuaded that our conclusions on the burden of proof in Hillman were inapplicable to a particular type of case or were unconstitutional or otherwise in error, we would not be bound to apply those conclusions.

As shown by the decision in Cross Creek Health Care Center, DAB No. 1665 (1998), the Board has not treated the legal conclusions in Hillman as a binding rule, applicable to all Part 498 proceedings. There, the Board briefly addressed an argument (made for the first time in petitioner's reply brief) that the ALJ had erred in determining that the conclusions in Hillman on burden of proof applied to a case involving a finding that a skilled nursing facility (SNF) was not complying substantially with Medicare requirements, resulting in imposition of a CMP. The Board recognized that program requirements for SNFs under Medicare (and other long-term care facilities under Medicaid) differ somewhat from requirements for other providers (such as Hillman, which was a rehabilitation agency) and that CMPs might raise some issues different from termination as a remedy. The Board concluded, nonetheless, that the rationale for allocating the burden of proof as discussed in Hillman applied in this context as well. Cross Creek Health Care Center, DAB No. 1665, at 13, n.10 (1998).

Subsequently, an ALJ decision applying the Hillman conclusions in the context of a CMP imposed on an SNF was challenged before the Board and in court. The Board held, and the court affirmed, that allocation of burden of proof is material only where the evidence is in equipoise and that the evidence was not in equipoise in that case. Fairfax Nursing Home, Inc. v. U.S. Dep't of Health and Human Services, 300 F.3d 835, 840, n.4 (7th Cir. 2002), on appeal from Fairfax Nursing Home, Inc., DAB No. 1794 (2001), cert. denied 537 U.S. 1111 (2003). (11)

Accordingly, the legal conclusions in Hillman on the burden of proof fall within the definition of an "order," as do subsequent decisions adopting the rationale and conclusions from Hillman in other contexts. See Fairfax Nursing Home, DAB No. 1794, at 8 (2002)("The Board's decision in Hillman is thus in the nature of an order which, while establishing precedent for the ALJs hearings these cases, is not a 'rule' under the APA.") The APA definition of "order" excludes the concept of rulemaking. We therefore reject Batavia's argument that the allocation of the burden of proof in Hillman is a substantive rule that required notice and comment rulemaking. (12)

Section 205(a) of the Act provides no basis for reversal of the ALJ's allocation of burden of proof in this case.

Batavia also argued that Congress intended that the agency promulgate rules and regulations to govern "the nature and extent of the proofs" presented at the hearing. Batavia argued that section 205(a) of the Act (42 U.S.C. 405(a)) mandates that CMS undertake formal rulemaking to "adopt rules and regulations" governing the burden of proof in a case involving a CMP. RR at 5-6. (13)

Section 205(a) reads as follows:

The Commissioner of Social Security shall have full power and authority to make rules and regulations and to establish procedures, not inconsistent with the provisions of this title, which are necessary or appropriate to carry out such provisions, and shall adopt reasonable and proper rules and regulations to regulate and provide for the nature and extent of the proofs and evidence and the method of taking and furnishing the same in order to establish the right to benefits hereunder.

(Emphasis added.) Section 1872 of the Act incorporates certain provisions of section 205 into the Medicare statute, including section 205(a), "to the same extent that they are applicable with respect to title II [Social Security disability cases]."

First, we note that the rights to benefits under the Medicare program accrue to the beneficiaries of the program, not to the providers of services. One of the benefits to which a Medicare-eligible individual is entitled is "to have payment made on his behalf" for certain extended care services provided by an SNF. Sections 1812(a)(2)(A) and 1861(h) of the Act (42 U.S.C.  1395d(a)(2)(A) and 1395x). Batavia did not point to any decisions applying section 205(a) to provider participation requirements, rather than to Medicare beneficiaries' rights, however. (14)

In any event, our conclusions in Hillman and the subsequent cases were based on an examination of the applicable statute and regulations, which do establish the requirements for providers to participate in the Medicare program (a prerequisite for receiving payments on behalf of a beneficiary), the method for providing evidence of compliance - that is, the survey and certification process, and the nature of the documentation that the providers must maintain and furnish upon request, such as resident assessments, plans of care, and medical records. See generally, 42 C.F.R. parts 483, 488, and 489. Moreover, while Part 498 does not specify burden of proof, it does establish how the evidence regarding substantial compliance with program requirements will be taken and furnished during a hearing on an initial determination that a provider is not in substantial compliance. Thus, read as a whole, the regulations do provide for the "nature and extent of the proofs and evidence and the method of taking and furnishing the same" with respect to provider participation in Medicare.

Finally, even if Batavia were correct in reading section 205(a) as requiring a rule or regulation explicitly addressing burden of proof in proceedings under Part 498, Batavia did not explain how the mere absence of such a rule or regulation would provide a basis for applying a different burden of proof than that applied by the ALJ in this case.

Allocating the burden of proof to Batavia does not violate the APA since Batavia is the proponent of an order finding it in substantial compliance with Medicare participation requirements.

Batavia also argued that Hillman violates section 7(c) of the APA, which, Batavia said, requires that CMS bear the "ultimate burden of proof" as the "proponent of a rule or order" imposing the CMP. Id., citing 5 U.S.C. 556(d). (15)

Batavia's reading of the APA and cited case law is flawed. "As fully discussed in Hillman, a provider participating in the federally-funded health care programs undertakes to maintain and demonstrate compliance, at all times, with all participation requirements." Meadow Wood Nursing Home, DAB No. 1841, at 7 (2002), citing Hillman, DAB No. 1611, at 12-17 (1997). Once found out of substantial compliance, Batavia required certification of compliance to continue participating in, and receiving payment from, the Medicare program. 42 C.F.R.  488.330(b)(1). In Hillman, the Board noted that a provider found out of compliance with program requirements "is the proponent of an order certifying it as qualified to participate in the program and to receive Medicare payment for services rendered . . . ." Hillman, DAB No. 1611, at 17 (1997).

Batavia conceded that the Supreme Court has placed the burden of proof on the claimant for governmental benefits when evidence is evenly balanced. RR at 4, citing Greenwich Collieries, 512 U.S. at 281 (benefits claimant bears the burden of persuasion). (16) Even when the claim is for a non-monetary benefit or privilege, the burden remains on the claimant as the proponent of the rule or order. See, e.g., U.S. Steel Corp. v. Train, 556 F.2d 822, 834 (7th Cir. 1977)("U.S. Steel, as the applicant for a permit without which it would be forbidden by law to discharge pollutants, is the proponent."); Day v. NTSB, 414 F.2d 950, 952 (5th Cir. 1969)(Section 556(d) technically inapplicable, but burden of proof properly on pilot for certification of fitness to fly). The Medicare statute governs payment for SNF services; like for other providers, having a provider agreement is not sufficient as a basis for determining that payment to an SNF on behalf of a beneficiary is authorized. (17) While section 1819(g) of the Act permits the Secretary to make payments to some facilities not substantially complying with the requirements, there are statutory conditions for such payments, restrictions on the period of time during which such payments may be made, and, if the denial of payments remedy is invoked, also restrictions on for whom the payments may be made. (18) An SNF appealing a finding that it is not substantially complying with the requirements is seeking to have payments made without those restrictions.

In summary, Batavia seeks from the government an order certifying that it is in substantial compliance with SNF requirements, so that it may continue to participate in the Medicare program with no restrictions on payment. Thus, placing the burden of proof on Batavia to show that it is in substantial compliance is consistent with section 7(c) of the APA.

We also reject Batavia's argument that CMS should bear the burden of proof here because governmental entities bear the "burden of proof" when imposing a fine or sanction. (19) RR at 3-4. Batavia cited as support Steadman v. SEC, 450 U.S. 91 (1981), which involved disciplinary proceedings against a broker for violations of numerous federal securities laws in managing mutual funds. Id. at 93. However, as explained in Greenwich Collieries, "it was uncontested in [Steadman] that the burden of persuasion was on the Government in a securities disciplinary proceeding." Greenwich Collieries, 512 U.S. at 290 (Souter, J., dissenting). The Steadman proceedings were governed by entirely different statutory and regulatory provisions than the survey and certification structure established for providers seeking to participate in the Medicare program. Steadman is inapposite.

Similarly, Batavia's reliance on Merritt v. Federal Maritime Commission, 960 F.2d 15 (7th Cir. 1992) and Bosma v. U.S. Dept. of Agriculture, 754 F.2d 804 (9th Cir. 1984) is also misplaced. Indeed, rather than undermine the Hillman rationale, Merritt and Bosma actually support it. (20) Merritt requires only that an agency "introduce initial evidence on an issue . . . ." Merritt, 960 F.2d at 18. Bosma also states that the agency "was . . . required to produce evidence . . . ." Bosma, 754 F.2d at 810. Although they involve different statutory and regulatory structures, Merritt and Bosma support our conclusion that CMS, the agency in this case, must come forward with or produce sufficient evidence on disputed facts that, together with the undisputed facts, will establish a prima facie case. We find no basis for Batavia's contention that they require that we place the ultimate burden of persuasion upon CMS.

Even if Batavia were not the proponent of the rule or order in this case (and we find that it is), section 7(c) provides for allocating the burden of proof to the proponent "[e]xcept as otherwise provided by statute . . . ." 5 U.S.C. 556(d). Hillman provides a detailed analysis of how the statutory and regulatory structure of the Medicare program places the burden of proving substantial compliance generally on the provider of services. Hillman, DAB No. 1611, at 12-17 (1997). This analysis was affirmed by the United States District Court for the District of New Jersey, which found no inconsistency between the allocation of the burden of proof under Hillman and the provisions of the APA. Hillman, No. 98-3789, at 25-27 (GEB)(D.N.J. May 13, 1999). (21) Batavia pointed to no new authority calling for a different result, and we see nothing in the record to suggest one.

Further, as we noted in Hillman, Congress had the opportunity to reject the agency's historical allocation of the burden of proof to the provider and has not done so. Hillman, DAB No. 1611, at 17-20 (1997)("These decisions evidence a long-standing interpretation [allocating the ultimate burden of persuasion to the provider], which Congress has not acted to overturn.") The CMP remedy was added as a remedy for facility noncompliance in the Nursing Home Reform Act, a part of the Omnibus Budget Reconciliation Act of 1987. Pub. L. 100-203, 4203. The agency had historically placed the burden of proving substantial compliance on the provider in termination hearings. Hillman, DAB No. 1611, at 18 (1997)(citations omitted). (22) When enacting the Nursing Home Reform Act, Congress did not revise this standard, and "[C]ongressional failure to revise or repeal the agency's interpretations is persuasive evidence that the interpretation is the one intended by Congress." Bell Aerosopace, 416 U.S. at 275.

While Congress did provide other remedies, including CMPs, as alternatives to termination when an SNF is found not to be in substantial compliance, Batavia pointed to nothing in the history or language of these provisions that would indicate that the burden of proof on the issue of substantial compliance should vary, depending on the remedy chosen. If anything, the Nursing Home Reform Act reinforced the importance of the survey and certification process and the Secretary's responsibility to assure that the requirements for the provision of care in SNFs, and the enforcement of such requirements, are adequate to protect the health, safety, welfare, and rights of residents and to promote the effective and efficient use of federal moneys. See, e.g., sections 1819(f) and (g) of the Act. We therefore conclude that the statute places the burden of proof upon an SNF to show that it was in substantial compliance.

For the above reasons, we reject Batavia's argument that the APA requires that CMS has the burden to prove that Batavia was not in substantial compliance with program requirements.

The fact that different hearing rights apply when a CMP is the remedy selected for noncompliance does not require that a different burden of proof apply.

Batavia argued that, in placing the burden of proof on Batavia, the ALJ failed to follow the regulatory requirements for hearings imposing a CMP, citing provisions of 42 C.F.R. Part 1005. Reply Br. at 5-6. Hearings involving the imposition of a CMP by CMS under 42 C.F.R. Part 488 are found at 42 C.F.R. Part 498, not Part 1005, however. 42 C.F.R. 498.3(a)(3)(ii), citing 42 C.F.R. 488.330(e); Carrier Mills Nursing Home, DAB No. 1883, at 6, n.2 (2003). Thus, the burden of proof provision in Part 1005 does not apply in this proceeding.

Implicit in Batavia's argument, however, is the issue of whether CMPs imposed on an SNF under section 1819 of the Act should be subject to the same burden of proof as CMPs under Part 1005, since those proceedings are governed by section 1128A of the Act and since section 1819(h)(2)(B)(ii) of the Act (42 U.S.C. 1395i-3(h)(2)(B)(ii)), incorporates by reference section 1128A(c)-(n) of the Act (42 U.S.C. 1320a-7a(c)-(n)). Under these provisions, a CMP may not be collected until after a hearing is provided. Section 1128A is silent on burden of proof, however, and the nature and purpose of a CMP imposed under 1128A(a) or (b) on an individual who has engaged in fraudulent or abusive activities is different from the nature and purpose of a CMP in the context of provider participation.

Moreover, while Congress provided for a pre-remedy hearing in the case of CMPs and accorded certain other rights that do not apply when termination or some other remedy is imposed, nothing in the statute or legislative history suggests that Congress expected CMS to meet a higher burden on the issue of whether an SNF is in substantial compliance when a CMP is imposed than what CMS must meet to terminate an SNF from the program altogether. Indeed, as the Board noted in Cross Creek, CMS may impose more than one remedy on an SNF, and, therefore, "treating a civil money penalty remedy differently from a termination or denial of payment remedy would lead to the anomalous result of having different burdens of proof being applied to the same facts in the same hearing." Cross Creek Health Care Center, DAB No. 1665, at 13, n.10 (1998).

Moreover, the regulations implementing the Nursing Reform Act continued to treat a certification of noncompliance as superseding any previous certification of compliance, leaving the facility as the proponent of an order certifying it as in substantial compliance if it wishes to avoid imposition of any remedy. 42 C.F.R. 488.330(b)(2).

Accordingly, we conclude that the fact that different statutory hearing rights apply to CMPs imposed on SNFs than apply to provider terminations generally is not a basis for applying a different burden of proof on the issue of substantial compliance.

The ALJ is not required to make findings of fact and conclusions of law on deficiencies that are not necessary to support the CMP imposed.

Batavia argued that the ALJ erred by failing to make findings of fact and conclusions of law on all deficiencies cited by ODH, not simply the Level G deficiencies analyzed in the ALJ Decision. Batavia maintained that since the ALJ failed to find that CMS had made a prima facie case with respect to the unaddressed deficiencies, then Batavia "must prevail on those findings," even under the disputed Hillman standard. RR at 7. Batavia argued that a determination must be made regarding the "residual life" of those deficiencies. P. Reply Br. at 9. (23)

CMS's determination to impose a CMP of $600 per day was based upon the findings of the state survey agency, which concluded that Batavia had failed to comply substantially with multiple requirements for participation. The ALJ Decision notes five Level G deficiencies, twelve Level D deficiencies, and one Level E deficiency cited during the standard and revisit surveys, in addition to one Life Code Survey deficiency. The ALJ stated that he addressed the Level G deficiencies in his decision, as they alone provided a sufficient basis for upholding the CMP imposed. ALJ Decision at 4.

CMS's determination to impose the CMP was based on the findings of the state survey agency, which concluded that Batavia failed to comply substantially with participation requirements categorized by CMS at Levels D, E, and G. ALJ Decision at 2. The regulations provide that CMS will select a Category 2 remedy for Level G deficiencies, which can include a CMP in the range of $50 - $3000. (24) 42 C.F.R. 488.408(d)(2); SOM 7400E.1. In this case, CMS selected a Category 2 remedy, a CMP in the amount of $600 per day, for Batavia's failure to maintain substantial compliance with participation requirements.

First, contrary to Batavia's arguments, we note that an ALJ's failure to address certain deficiencies found by CMS is not tantamount to findings in favor of Batavia on those deficiencies. If we disagreed with the ALJ that the deficiencies he did not address were not material to his decisionmaking, the appropriate result would be for us to remand the case to the ALJ to make additional findings (or, if appropriate, to make additional findings ourselves).

In examining whether the unaddressed deficiencies were material, we must look at the issues to be decided by the ALJ. In cases involving a CMP imposed on a per day basis, there are three potential issues: (1) Was there a basis for imposing any CMP (that is, did the provider in fact fail to comply substantially with program requirements)? (2) What was the duration of the period of noncompliance? (25) (3) Was the amount of the CMP reasonable? (26)

We conclude that it was unnecessary for the ALJ to address all of the deficiencies in order to conclude that CMS had a basis for imposing a CMP. As we have previously held, "even one isolated instance of non-compliance having a potential for more than minimal harm may be the basis for a finding" that the facility has failed to comply substantially with a participation requirement and, consequently, may lead to the imposition of a CMP. Ridge Terrace, DAB No. 1834, at 6 (2002), citing Lake City Extended Care Center, DAB No. 1658 (1998). Since we conclude below that the ALJ properly found that Batavia was not in substantial compliance with each of the requirements cited as the basis for a Level G deficiency, CMS was authorized to impose a CMP and could do so irrespective of whether Batavia was in substantial compliance with other participation requirements.

The second prong of the analysis concerns the duration of the CMP imposed. We note first that Batavia does not challenge the duration of the CMP, only its basis and reasonableness. Nonetheless, the aggregate amount of the CMP is consistent with the duration of Batavia's lack of substantial compliance. In its August 13, 1999 notice, ODH informed Batavia that it would advise CMS to impose a $600 per day CMP (effective August 6, 1999) if Batavia were not to achieve substantial compliance by September 25, 1999. CMS Ex. 12. The revisit survey on September 29, 1999, revealed that Batavia remained out of substantial compliance with program requirements (CMS Ex. 15) and ODH again notified Batavia that it would advise CMS to impose a $600 per day CMP (effective August 6, 1999) until Batavia returned to substantial compliance. A follow-up survey by ODH on October 21, 1999, verified Batavia's allegations of substantial compliance effective October 1, 1999. CMS ultimately imposed a CMP in the aggregate amount of $33,600, constituting a $600 per day CMP for the period August 6, 1999 through September 30, 1999. We find that the duration of the CMP is consistent with the period of Batavia's lack of substantial compliance with program requirements, based on the deficiencies addressed in the ALJ Decision.

The third prong of the analysis requires an assessment of the reasonableness of the CMP. As discussed in relation to FFCL 6, infra pp. 59-64, we affirm the ALJ's conclusion that the amount of the CMP imposed was "reasonable" within the regulatory criteria, even without considering the additional deficiencies alleged by CMS.

In summary, we find that CMS had a basis for imposing a CMP based on the Level G deficiencies cited in the standard and revisit surveys. We also find that the duration of the CMP is consistent with the period during which Batavia remained out of substantial compliance with the program requirements addressed in the ALJ Decision. We additionally find, as discussed below, that the amount of the CMP is reasonable under the relevant regulatory criteria, even without considering the additional deficiencies. Accordingly, the ALJ was not required to address in his decision all deficiencies cited during the standard and revisit surveys in affirming CMS's imposition of the CMP in this case.

Batavia's general objections do not provide a basis for reversing the ALJ Decision.

In challenging all FFCLs, Batavia raised several general objections as threshold issues. Batavia argued first that the ALJ failed to consider adequately Batavia's documentary and testimonial evidence. RR at 7. Batavia contended, instead, that the ALJ relied upon "selective portions of the facility's records . . . ." Id. Batavia also contended that the ALJ held facility staff to a higher standard of care than required by the Act. Id. Batavia next objected that the ALJ failed to consider residents who did not want or were unable to refuse care, their adverse reactions, or their changed conditions. Id. Batavia concluded by asserting that its witnesses were licensed professionals with greater knowledge of residents than state surveyors. Id. at 7-8.

As stated above, we uphold an ALJ decision when it is supported by substantial evidence and free of legal error. See supra pp. 6-7. Substantial evidence is "relevant evidence" which a reasonable person "might" accept to reach the conclusion drawn. See supra p. 7. The ALJ is not required to cite all evidence in the record supporting his or her findings, so long as substantial evidence in the record as a whole supports these findings. Id. In any event, contrary to Batavia's contention, we find that in general the ALJ Decision adequately cites to and considers Batavia's documentary and testimonial evidence. (27)

We also reject Batavia's contention that the ALJ appeared to require that facility staff "must at all times deliver the highest possible standard" of care, in violation of 42 U.S.C.  1395i-3(b)(4)(A) (Section 1819(b)(4)(A) of the Act). That section of the Act requires, in relevant part, that a facility provide nursing, rehabilitative, and medically-related social services to attain the highest practicable physical, mental, and psychosocial well-being of the resident to the extent needed to fulfill all plans of care. (28) We find no indication that the ALJ employed a form of "strict liability," as Batavia implied. Section 1819(b)(2) and 42 C.F.R. 483.25 make clear that the care and services must be provided in accordance with the plan of care, which must be based on a resident assessment. The facility must also comply with the remaining participation requirements established in the regulations. As discussed below, substantial evidence in the record as a whole supports the ALJ's findings that Batavia failed to comply with these requirements.

Further, we cannot agree with Batavia that the ALJ erred by failing to analyze the provision of care that would meet these standards to "an individual who is without the desire or ability to reject that care . . . ." RR at 7. This argument lacks coherence. The role of the ALJ is to review the deficiency findings to determine whether the facility was complying substantially with the participation requirements, not to speculate about the effect of providing required care to a resident who does not wish to or cannot turn it away. Batavia pointed to no legal authority or record evidence to support this curious proposition. We find the argument as unavailing as it is puzzling.

We also reject Batavia's general contention that the ALJ did not adequately consider resident adverse reactions or changed conditions. Id. As discussed below, Batavia was cited on more than one occasion for failing to provide care ordered by the physician and also for failing to notify the physician of significant changes in a resident's condition. The ALJ reviewed resident adverse reactions and changing conditions when affirming these deficiency citations. We thus find no basis for this general contention.

Finally, Batavia argued that all of its witnesses are licensed professionals with extensive training, background, and experience in the nursing profession. RR at 7. Batavia contended that these witnesses also possess a "deep, long term knowledge of each resident based upon routine and/or daily contact" that the state surveyors lacked. Id. at 7-8.

In some circumstances, if a qualified individual who cared for a specific resident over a long period of time testified about the resident and that testimony was consistent with documentary support that was complete, familiarity with a resident might be a reason to give more weight to the caretaker's testimony. Koester Pavilion, DAB No. 1750, at 15 (2000). Merely because some staff might generally be more familiar with residents, however, is not a reason to adopt a general rule requiring ALJs to give more weight to all testimony by staff members. Further, in evaluating testimony, an ALJ may reasonably take into account factors such as witness qualifications and experience, as well as self-interest.

The ALJ heard testimony on the qualifications and experience of Batavia witnesses who were current or former staff or consultants to the facility: Tamela Lewis (registered nurse), Amy Christina Boehm (licensed social worker), Mary L. Palmer (former administrator), Rebecca Vincent (licensed practical nurse), Carol Ann Watson (licensed practical nurse), and Kimberley Parks (former Batavia assistant director of nursing, current regional director for corporate owner). Tr. 213-226 (Lewis); Tr. 228-236 (Boehm); Tr. 238-255 (Palmer); Tr. 259-282 (Vincent); Tr. 290-298 (Watson), and Tr. 298-326 (Parks). The ALJ also heard testimony on the qualifications of the state surveyors, CMS witnesses Debbie Truett, Sharon Dunn, Sylvia Grimes, and Jacqueline Kardasz, all of whom participated in the standard survey and some of whom participated in the revisit survey. Tr. at 24-28 (Truett); 119-120 (Dunn); 151-152 (Grimes); and 162-163 (Kardasz).

Absent clear error, we defer to the findings of the ALJ on weight and credibility of testimony. Koester Pavilion, DAB No. 1750, at 15 (2000). Here, as in Koester Pavilion, "[w]e find no compelling reason to reject the ALJ's determination about the relative credibility and persuasiveness of the testimony of these witnesses." Id. at 22. We conclude that the ALJ did not err in giving more weight to observations, record review, and testimony provided by qualified state surveyors than to those made by the current or former facility staff who testified here.

The ALJ's FFCLs are supported by substantial evidence in the record as a whole and are legally correct.

Having rejected Batavia's general objections, we now turn to its specific challenges. In reviewing the FFCLs, our discussion first sets forth the applicable requirement. We next summarize the ALJ's findings, followed by Batavia's contentions. We then analyze whether the ALJ's findings are supported by substantial evidence in the record as a whole and reflect the correct interpretation of the participation requirement.

FFCL 1. As of the survey ending on August 6, 1999, Petitioner was out of compliance with the participation requirement at 42 C.F.R.  483.10(b)(11)(F Tag 157 on the statement of deficiencies (CMS 2567 or 2567) dated August 6, 1999).

A nursing facility's obligations regarding notification of changes in a resident's condition are set forth in 42 C.F.R.  483.10(b)(11). That section provides, in relevant part: "A facility must immediately . . . consult with the resident's physician . . . when there is . . . (B) A significant change in the resident's physical . . . status (i.e., a deterioration in health . . . status in either life-threatening conditions or clinical complications); (C) A need to alter treatment significantly (i.e., a need to discontinue an existing form of treatment due to adverse consequences, or to commence a new form of treatment) . . . ." Id. The CMS 2567 states that with respect to Residents 102 and 2, "based on surveyor observation, staff interview and record review it was determined the facility failed to promptly notify the physician of a change in the resident's health status." CMS Ex. 4, at 2-3.

Resident 102

The ALJ described the readmission of this resident to Batavia on July 22, 1999, following hospitalization that included surgery for small bowel obstruction. ALJ Decision at 4, citing P. Ex. 12, at 36. The clinical record for that date shows that the resident's small bowel obstruction surgical site was "dry and intact" upon readmission. P. Ex. 12, at 36. The ALJ also cited to an entry for July 22nd (actually written on July 26th) on a "Skin Condition Progress Report" suggesting "redness" and a small amount of yellow drainage at the wound site. On July 24th, a 2:15 PM nursing entry for the first time reflects a "large amount of foul, green drainage." The nursing supervisor was called. This discharge continued throughout the next day, July 25th, and into the night. In mid-afternoon on July 26th, nursing notes indicate that the facility called the physician about the drainage and received orders for a site culture, wound cleaning, and antibiotic treatment. Three hours later, the resident's skin is documented as mottled and cyanotic, and she required emergency transport to an acute care hospital. (29) ALJ Decision at 4-5, citing P. Exs. 12 and 12A.

The ALJ upheld the deficiency citation, finding that Batavia did not address the two-day delay in notifying the physician after discovering the foul, green drainage on July 24th. ALJ Decision at 5. Batavia argued that the ALJ's findings should be overturned because (1) the resident was already on an antibiotic when readmitted; (2) the resident's physician was the physician at the hospital and "knew the situation" because "drainage" was noted upon readmission; (3) the drainage was not necessarily an infection, but "likely could have been bile and stool;" (4) the physician was notified when odor began; and (5) the resident initially refused to go to the hospital. RR at 8-9.

We first address Batavia's submission of new evidence on appeal. In support of its argument that the drainage was not necessarily an infection, Batavia submitted a one-page progress note on Mercy Health Partners letterhead, dated July 27, 1999, and requested that the Board consider the new record. RR at 8, n.1. Under the regulations, the Board has authority to admit additional evidence on appeal "if the Board considers that the additional evidence is relevant and material to an issue before it." 42 C.F.R.  498.86(a). However, this regulation is permissive and does not require the Board to admit additional evidence, even if it is material and relevant. Our Guidelines provide that we will admit new evidence into the record upon appeal only when "the proponent demonstrates good cause for not producing the evidence during proceedings before the ALJ." Guidelines, 3(f). Batavia offered no argument as to why this document could not have been presented before or during the ALJ hearing. We therefore find that good cause has not been demonstrated and decline to admit the progress note as new evidence. (30)

Batavia cited no evidence to support its contention that the resident was already on an antibiotic at the time of readmission to the facility on July 22, and the medication orders in the record do not indicate any new medication orders between the surgery and the readmission date. See P. Ex. 12, at 3-6. Moreover, while the Skin Condition Report completed July 26 "for" July 22 indicates a "small amount of yellow" drainage on a dressing which appears to be related to the abdominal site at issue (although this is not entirely clear) (P. Ex. 12A, at 7), the contemporaneously made hospital note the date before reported the site to be dry and intact and the July 22 nurse's note on readmission also reported the dressing to the abdomen to be dry and intact. P. Ex. 12, at 90, 36. Thus, the only evidence from which one might infer that the attending physician knew the site was infected before he was informed on July 26 is the nursing note made on July 26 for July 22. Since that note was ambiguous and was not actually recorded until July 26, and since Batavia presented no testimony from the physician or the nurse who made the later note, we decline to draw such an inference.

In any event, Batavia presented no evidence to show that the first-time onset of foul, green drainage from the abdominal wound site on July 24, 1999, was not a significant change in Resident 102's physical condition that would require immediate consultation with the physician. Even assuming some yellow discharge on July 22, substantial evidence establishes that two days later, on July 24, this same incision not only emitted a discharge, but one that was described as both "green" and "foul." When it was brought to the attending physician's attention on July 26, he ordered an antibiotic that same day for the purposes of controlling infection. ALJ Decision at 4, citing P. Ex. 12A, at 6; CMS Ex. 4, at 3; CMS Ex. 30, at 12. The ALJ could reasonably conclude that the change in the status of the incision was the sort of significant change in the resident's physical status that required immediate consultation with the physician.

We also reject Batavia's argument that since the "foul green drainage" was not "described as being pus or mucous like," it could have actually been bile or stool. Batavia cited to nothing in the record to support this speculation, other than to new evidence submitted with the Request for Review. As previously explained, we decline to admit the proffered evidence into the record and, in any event, disagree that it supports that the drainage was bile or stool. See supra p. 29, n.30.

We also reject the argument that Batavia's notification of the physician on July 26 was sufficient to meet the regulatory standard. As explained above, the onset of the foul, green drainage on July 24 was the significant change in status that then triggered the requirement to notify the physician immediately.

We therefore find that the ALJ Decision, with respect to this deficiency and Resident 102, is supported by substantial evidence on the record as a whole.

Resident 2

The ALJ discussed a fall to the floor and subsequent x-ray involving Resident 2. On July 24, 1999, Resident 2 fell onto the floor. The patient subsequently complained of pain, and the physician ordered a lumbar spine x-ray on July 25th. On July 26th, the resident fell again. The report from the radiologist described the x-ray as "incomplete," since the lumbar area could not be visualized from a lateral view, and a "non-portable film" was recommended as preferable. After July 26th, the record reflects that the resident continued to complain of severe back pain and received pain medication. The record does not show, however, that the facility notified the resident's physician about the incomplete x-ray until ten days later, three days into the standard survey. ALJ Decision at 5-6, citing P. Ex. 1. (31)

The ALJ upheld the deficiency, finding that Batavia failed to address why the physician was not immediately consulted regarding the incomplete x-ray. ALJ Decision at 6. Batavia argued that the ALJ's findings should be overturned, because (1) the surveyors incorrectly related the July 25th x-ray request to the July 26th fall and the resident's expressions of back pain; (2) the x-ray was ordered not in relation to a fall, but in evaluation of the resident's degenerative conditions; (3) a calcium deficiency caused the x-ray to be inconclusive; (4) the physician was notified of the July 26th fall; (5) the resident was on pain medication and her complaints of pain could have been a manifestation of her mental health condition; and (6) she later received an x-ray, which showed no injury from the fall. (32) RR at 9-10.

The record shows that the physician ordered an x-ray of the lumbar spine on July 25, after the fall on July 24, at the same time that he ordered Vicodin for the pain related to the fall. P. Ex. 1, at 60. There is no indication that the purpose of the x-ray was to evaluate degenerative conditions. Rather, nurses' notes show that on July 24, the resident had already complained of pain related to the "fall on previous shift." Id. at 87. The nurses' notes also show that the x-ray was obtained at 10:00 AM on July 26, after the second fall was documented as occurring at 4:00 AM that day and more complaints of back pain were recorded. Id. at 86.

There is no support in the record for Batavia's assertion that Batavia delayed contacting the physician since it was evaluating whether the resident's complaints of back pain were real. To the contrary, the notes show that Batavia was administering pain medication in response to the resident's complaints. Also, notes on July 28 related the complaints of back pain to "fall on 7/25/99." Id. at 85. Nor did Batavia point to any evidence that the resident complained of back pain prior to the falls. Contrary to Batavia's assertion, subsequent records show that the resident suffered a compression fracture of the lumbar vertebrae. Id. at 50.

The above regulatory standard required Batavia to immediately consult with the physician upon a significant change in the resident's physical condition and when there is a need to alter treatment significantly. Implicit in that standard is that a facility must immediately inform a physician when it is unable to provide requested clinical information that would determine whether current treatment should be altered. We find persuasive the surveyor's testimony that the resident continued to experience pain without further diagnostic testing, due to the lack of physician notification. Tr. at 122. We thus find that reporting an inconclusive x-ray falls within the regulatory ambit and that substantial evidence in the record as a whole shows that Batavia failed to do so.

We therefore find that the ALJ Decision, with respect to this deficiency and Resident 2, is supported by substantial evidence on the record as a whole.

FFCL 2. As of the survey ending on August 6, 1999, Petitioner was out of compliance with the participation requirement at 42 C.F.R.
483.25 (F Tag 309 on the CMS 2567 dated August 6, 1999).

A nursing home's obligations regarding quality of care are set forth in 42 C.F.R. 483.25, which reads, in relevant part, as follows: "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." The CMS 2567 states that with respect to Residents 154, 186, and 39, Batavia "failed to ensure that necessary care and services were provided to residents in accordance with their comprehensive assessments." CMS Ex. 4, at 12.

Resident 154

The ALJ discussed skin breakdown and foot injuries in relation to Resident 154. ALJ Decision at 7-9. He first noted that Batavia did not "really contest the facts as set forth in the [CMS] 2567." ALJ Decision at 7. According to the ALJ, the CMS 2567 indicated that Batavia did not implement interventions necessary to prevent a decline in or protect the condition of the resident's feet. Id. (33)

Specifically, the ALJ noted the progression of a small "purple area noted on inner aspect" of the resident's left heel on July 11, 1999, to observation of "a 4x4.2 centimeter" sore that emitted "bloody brown drainage" during treatment on August 5, 1999. P. Ex. 17, at 70, 50; CMS Ex. 30, at 70. The ALJ also discussed surveyor observations that the resident's feet were exposed to injury when dragged beneath the wheelchair and also when wearing certain shoes. CMS Ex. 4, at 13; P. Ex. 17, at 49. The ALJ then considered testimony from Surveyor Truett and from Batavia witness Tamela Lewis.

The ALJ upheld the surveyor's finding of a deficiency, finding that Batavia failed to dispute that the resident, assessed as being at risk for skin breakdown, actually suffered skin breakdown (as evidenced by the left heel sore). The ALJ further found that Batavia failed to implement an adequate care plan to protect the resident's feet from injury during wheelchair transport and while wearing certain shoes.

Batavia argued that the ALJ's finding should be overturned, because (1) the tops of the resident's feet were not injured and, in any event, were not an area of concern; (2) the resident's physical diagnoses affected the ability of "any wound" to heal; and (3) the facility had multiple interventions in place for the resident's feet, including a physician's order for treatment of the left heel, a skin maintenance program, a turning program, heel protectors, and a special bed mattress (a pressure relieving bed). RR at 10-11.

We first note Batavia's new assertion that the resident's wheelchair was equipped with a drop seat cushion so that the resident could propel the wheelchair with her feet. P. Reply Br. at 9. Batavia cited nothing in the record in support of this contention. (34) However, even if this were true, we cannot agree that it provides a basis for finding that there was no deficiency as to Resident 154. When a facility uses interventions (including a drop seat cushion) to allow a resident to propel his or her wheelchair by foot, the facility must also take care that the resident's feet are not injured as a result. The CMS 2567 documents multiple observations that the resident's feet were dragged under the wheelchair when pushed by facility staff. CMS Ex. 4, at 13. A resident in a drop seat wheelchair would sit closer to the floor. Where it could reasonably foresee that foot dragging could cause skin breakdown, the facility would need to ensure that the resident's feet would not "bend forward" under the wheelchair when pushed by someone else. CMS Ex. 4, at 13.

With respect to the remaining arguments, Batavia offered no new argument and no new interpretation of record evidence to support overturning the ALJ. Specifically, Batavia did not contest that the facility's assessment noted the resident at risk for skin breakdown in the feet. Further, Batavia did not argue that the wound to the left heel did not over time enlarge and burst with bloody discharge, as reflected in the CMS 2567. Batavia also did not challenge the surveyor's observation that the resident's feet dragged beneath the wheelchair on three separate occasions. Batavia also offered no evidence to rebut the surveyor's observation of a new injury to the right foot, that the "bruise on top big toe new - saw dragging last night & today nurse states bruise & open sore from dragging." CMS Ex. 34, at 127.

We therefore find that the ALJ Decision, with respect to this deficiency and Resident 154, is supported by substantial evidence on the record as a whole.

Resident 186

The ALJ discussed anti-embolism hose in relation to Resident 186. ALJ Decision at 9. Anti-embolism hose are used for residents at risk for deep vein thrombosis or blood clots in the lower extremities. Tr. at 46.

The ALJ Decision states that the physician order called for the resident to wear anti-embolism hose "at all times." The surveyor observed that the resident was not wearing the hose on August 2, 1999 (12:20 PM to 2:00 PM), August 3, 1999 (7:20 AM to 10:45 AM and at 12:15 PM), August 4, 1999 (7:45 AM), and August 6, 1999 (7:42 AM). The ALJ upheld the deficiency finding that Batavia failed to show that it adhered to the physician's order.

Batavia argued that the ALJ's findings should be overturned because (1) the resident was not at "high risk;" (2) the stockings had to be removed for hygiene and other reasons; (3) the surveyors did not consult facility protocol regarding anti-embolism stockings; and (4) the resident received aspirin "as it is more effective" for noncompliant residents. RR at 11. Batavia also argued that the facility could not force the resident to wear hose and had to honor the resident's decision to refuse care. P. Reply Br. at 11.

We first address Batavia's mischaracterization of testimony. Batavia stated that Ms. Truett testified that anti-embolism hose are intended for residents "at high risk" for thrombus and that the resident was not at high risk. RR at 11, citing Tr. at 44-46. Ms. Truett's testimony actually states that "[a]nti-embolism hose are usually implemented for residents at risk for deep vein thrombosis or blood clots [in] lower extremities." Tr. at 46. We thus reject Batavia's overstatement as inconsistent with the record. However, even if Batavia's characterization were accurate (and it is not), the degree of a patient's risk for thrombosis is not relevant to Batavia's responsibility to provide care ordered by the physician.

The physician's order for the anti-embolism hose, documented as reviewed by staff on July 26, 1999, states: "appliance orders: bilateral knee high antiembolism stockings may remove daily for hygiene then reapply." P. Ex. 23, at 15. The surveyor observed that on more than one occasion, the resident was observed not wearing the hose. Surveyor Truett testified that the resident was not receiving hygiene when observed without the hose. Tr. at 115. These observations and testimony remain unrebutted by Batavia. The record instead supports the ALJ's reasonable conclusion that the resident was not wearing the ordered hose because the facility did not put them on.

The ALJ also was correct to reject Batavia's argument that the surveyor should have consulted facility protocols and practices regarding anti-embolism hose. First, these materials are not in the record. Second, even if they were relevant (which Batavia did not establish), such materials would not excuse Batavia's failure to follow the physician's order on multiple occasions. If facility staff questioned whether the hose were necessary, they should have discussed their concerns with the resident's physician, rather than ignoring his order.

Finally, Batavia argued that this resident received aspirin because aspirin is more effective for noncompliant residents. Batavia cited to nothing in the record to support, first, that aspirin was given; second, that the resident was noncompliant with or refused care; or third, that aspirin is actually effective in the prevention of a deep vein thrombus or blood clots. The record reflects only that the resident had orders for the non-aspirin pain reliever Tylenol during this period, which makes it unlikely that the resident was also receiving aspirin. P. Ex. 23, at 5. We therefore dismiss this assertion as both unsupported and irrelevant.

We therefore find that the ALJ Decision, with respect to this deficiency and Resident 186, is supported by substantial evidence on the record as a whole.

Resident 39

The ALJ also discussed anti-embolism hose ordered for Resident 39. ALJ Decision at 9-10. Batavia presented the same arguments for Resident 39 as for Resident 186, having combined the arguments for appeal.

As with Resident 186, we affirm the ALJ's findings with respect to Resident 39 as supported by substantial evidence on the record as a whole. The record reflects physician's orders for "bilat thigh hi ted hose on at all times - may remove daily for hytiene [sic] then reapply." P. Ex. 4, at 47, 48. The CMS 2567 reflects the surveyor's observations on three successive days, for periods up to three hours, that the resident was not wearing the hose ordered. CMS Ex. 4, at 15. Batavia did not dispute these facts. We find Batavia's arguments on appeal unpersuasive for reasons similar to those set forth in our prior discussion for Resident 186.

We therefore find that the ALJ Decision, with respect to this deficiency and Resident 39, is supported by substantial evidence on the record as a whole.

FFCL 3. As of the survey ending on August 6, 1999, Petitioner was out of compliance with the participation requirement at 42 C.F.R.  483.25(c) (F Tag 314 on the CMS 2567 dated August 6, 1999).

Resident 169

A nursing home's obligations regarding quality of care with respect to the prevention and treatment of pressure sores are set forth in 42 C.F.R. 483.25(c), which states:

Based on the comprehensive assessment of a resident, the facility must ensure that - (1) 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; and (2) A resident having pressure sores receives necessary treatment and services to promote healing, prevent infection and prevent new sores from developing.

The CMS 2567 states that Batavia "failed to ensure that [Resident 169] received the necessary treatment and services to promote healing" of pressure sores. CMS Ex. 4, at 17.

The ALJ discussed the development and progression of a wound on the resident's right heel. (35) ALJ Decision at 10-12. The CMS 2567 and the resident's medical records indicate the presence of a ruptured blister on the resident's right heel from May 2, 1999 through May 10, 1999, measured as 1 1/4 cm long and 1 cm wide. CMS Ex. 4, at 17; P. Ex. 20, at 66, 82. (36) An "Active Skin Problem POC" and a "Skin Condition Progress Report" document the presence of a blister at the same location two months later, on July 13, 1999. P. Ex. 20, at 79, 80. Nursing notes document the sore at "nickel to quarter size area of thick, white skin" with a half centimeter open area in the center and a slightly reddened surrounding area. Id. at 43.

The CMS 2567 states that "care planned interventions included heel pads on when in bed and a foot cushion on the wheelchair foot rests" and that the resident would not wear new shoes brought by the resident's family "until the sore healed." CMS Ex. 4, at 18. The CMS 2567 also reflects that on August 2, 1999, the surveyor observed the resident in bed without the heel pads. CMS Ex. 34, at 136. On August 3rd, the resident was observed sitting in her wheel chair wearing tennis shoes and socks. Id. at 134. On August 4th, the surveyor observed a nurse treat the resident's "lg open sore-encompassing entire RT outer part of heel." Id. at 30. The wound dimensions then measured 2.3x3 cm, with white, yellow, and red surrounding tissue. Id. The CMS 2567 also states: "On 8/4/99 nursing documented the sore had brown drainage with a black area noted at the sore site." CMS Ex. 4, at 18. On August 6th, the surveyor observed the resident lying in bed without wearing the heel protectors, although a nurse's aide had just exited the room. CMS Ex. 34, at 35.

The ALJ upheld the deficiency finding, concluding that even if he accepted all of Batavia's arguments as true, Batavia failed to maintain compliance with the requirement. ALJ Decision at 12. He also found "actual harm" to the resident, based on steady deterioration of the sore. Id. He further found that Batavia had not contested that its care plan included heel protectors and a foot cushion, or Surveyor Truett's observations that Batavia had not consistently implemented those interventions. Id.

Batavia argued that the ALJ's findings should be overturned, because (1) Surveyor Truett's testimony was not credible, as she provided inconsistent testimony on whether and when the resident was wearing socks; (2) the wound had become smaller, actually being correctly classified as a Stage II instead of a Stage IV pressure sore based on the wound debridement that occurred August 6, 1999; (3) there was "some question as to whether or not this was a pressure area versus a diabetic foot ulcer;" (4) the resident's physical condition contributed to the skin breakdown, and Batavia applied appropriate interventions; (5) the resident was noncompliant with care. RR at 11-12.

We first address Batavia's challenge to Surveyor Truett's credibility. Batavia asserted that Surveyor Truett cannot be deemed credible as she testified during her direct examination that she did not see Resident 169 wearing socks, but upon cross-examination, conceded that she had. RR at 11-12. Batavia provided no citation to her direct testimony. This purported contradiction can be found in its entirety during Ms. Truett's cross-examination. Tr. at 86; CMS Response (37) at 32-33 (discussion of conflicting testimony). During a brief colloquy with Batavia counsel, Ms. Truett referred to two separate pages in her notes. Tr. at 86, citing CMS Ex. 34, at 134, 34.

Batavia clearly failed to review these records. They indicate that Ms. Truett observed the resident wearing socks on August 4, 1999. CMS Ex. 34, at 34. Her notes from August 3, 1999, at 8:20 AM (when she said she observed the resident not wearing socks), are ambiguous, but can be read as indicating no socks. CMS Ex. 34, at 134. Since her testimony related to observations occurring on different days, we find Ms. Truett's testimony consistent and entirely credible. In any event, we generally defer to an ALJ's findings on witness credibility.

Batavia next argued that the wound to the right heel did not worsen during the relevant period. This position is not supported by the record. Batavia did not deny that the May 10 skin assessment identified the resident as at risk, based on a history of a pressure sore on the right heel. On June 1, 1999, the wound site was described as merely "discolored." P. Ex. 20, at 52. A July 13, 1999 nurse note describes an area on the right heel as "nickle to quarter size area of thick, white skin" with a .5 cm open area in the center and a slightly reddened surrounding area. P. Ex. 20, at 43. On August 3, 1999, Surveyor Truett observed the wound as an "area on RT heel dark in color can see dark drainage." CMS Ex. 34, at 38. (38) The next day, Ms. Truett observed treatment of this wound and documented a large open sore "encompassing entire RT outer part of heel," with a yellow center surrounded by white and red tissue. Id. at 30. The yellow tissue at the center measured 2 cm long by .6 cm wide (2x.6 cm). Id. Ms. Truett documented dimensions of the entire wound area as 2.3x3 cm "from white tissue edges." Id.

Batavia argued that these dimensions misrepresent the extent of the healing process and that wound debridement on August 6, 1999 revealed smaller dimensions. A nurse note of the same date relates the presence of granulating tissue, a physician report that "ulcer was healing," an overall wound area of 3 cm, and internal dimensions of 1x.5 cm. P. Ex. 20, at 80. Batavia also offered the testimony of Carol Watson that the wound was actually a Stage II pressure sore, rather than a Stage IV pressure sore. Tr. at 295.

While the dimensions documented on July 13, 1999 are somewhat imprecise, the record shows that the site had worsened between May and July 13. The facility's own evaluation attributed this to shoes purchased by the resident's family, but also indicated that the deterioration was not unavoidable. P. Ex. 20, at 87. We agree with the ALJ, moreover, that the record as a whole supports a conclusion that the wound grew larger from July 13, 1999 through Ms. Truett's documented observations during the standard survey. Thus, there is substantial evidence to support the ALJ's finding that the failure to take planned interventions to promote healing of the pressure sore, irrespective of the sore's progression or categorization as a Stage II or Stage IV sore, constituted actual harm to the resident. (39)

In any event, the ALJ did not have the authority to overturn the CMS finding here that there was actual harm. "Actual harm" is a level of severity used to categorize facility noncompliance. See SOM Appendix P, V.B. Under the regulations now applicable, a provider does not have the right to appeal a CMS determination of the level of noncompliance unless a successful challenge on this issue would affect either the range of CMP amounts that CMS could collect or a finding of substandard quality of care that results in loss of approval of a nurse aide training program. 42 C.F.R. 498.3(b)(14); see also 42 C.F.R. 498.3(d)(10)(ii). Batavia did not argue that either of these situations applied.

Batavia did suggest here, for the first time, that the instant wound may not have been a pressure area, but was instead a diabetic foot ulcer. In support, Batavia cited the direct testimony of Carol Watson, treatment nurse at Batavia. Ms. Watson was asked by Batavia counsel whether there was anything about the resident's diagnosis or condition that "would contribute to . . . or cause" a skin breakdown. Tr. at 295. Ms. Watson responded that the resident "had a lot of circulation problems, and she was a diabetic." Id.

We find this dialogue insufficient to raise a substantial question as to whether the instant wound was a pressure sore within the meaning of 42 C.F.R. 483.25(c). The witness's testimony, standing alone, neither establishes the patient's medical condition as the sole cause of the wound nor substantially diminishes the possibility or likelihood of other causes. The facility's own initial description of the wound as a "blister" falls within the definition of a pressure sore. Further, the record as a whole indicates that the resident had a history of a problem with the right heel and of both her attending physician and nursing staff addressing that problem with interventions, such as heel pads, that are consistent with pressure being a causative factor and that are identical to the interventions for the sore on the left heel, which was specifically identified as a pressure ulcer. P. Ex. 20, at 67. We thus find that the record does not support recharacterizing the wound at this stage of appeal.

Finally, Batavia argued that the resident was noncompliant with care. Batavia witness Carol Watson testified that Batavia "tried to keep heel pads on her [but s]he would kick them off . . . ." Tr. at 293. According to Ms. Watson, Batavia obtained a physician's order to apply gauze "so even if she kicked the heel pads off the area would still be protected." Id. Ms. Watson's testimony notwithstanding, this argument, too, is insufficient to overturn the ALJ's findings.

First, the only documentation of noncompliant behavior in wearing the heel pads is on August 13, 1999, after, not before, the survey. P. Ex. 20, at 85. Second, while the medical record does reveal orders for cleansing and treating the site (and applying gauze), given on July 13, 26, and 30, 1999, they do not specify that the gauze was a replacement for use of the heel pads and foot cushion, nor did Batavia claim that the POC was changed to eliminate these interventions. Further, Batavia offered no evidence that the resident had in fact worn heel pads that she kicked off prior to being observed by Ms. Truett. Finally, Batavia offered no rebuttal evidence to Surveyor Truett's observations that the resident was in the wheelchair without a foot cushion, in contravention of the planned interventions.

The crux of the deficiency is that Batavia failed to implement all of the planned interventions to promote healing of the pressure sore. Substantial evidence in the record supports this finding.

We therefore find that the ALJ Decision, with respect to this deficiency and Resident 169, is supported by substantial evidence on the record as a whole.

FFCL 4. As of the survey ending on August 6, 1999, Petitioner was out of compliance with the participation requirement at 42 C.F.R.  483.25(h)(2) (F Tag 324 on the CMS 2567 dated August 6, 1999).

A nursing home's obligations regarding supervision and assistance devices to prevent accidents are set forth in 42 C.F.R. 483.25(h)(2), which states that the "facility must ensure that . . . [e]ach resident receives adequate supervision and assistance devices to prevent accidents." The CMS 2567 states that "adequate supervision and assistance devices were [not] utilized correctly to prevent accidents." CMS Ex. 4, at 23.

Resident 39

The ALJ discussed a series of falls by Resident 39, in October and November 1998 and May 1999, and a history of other behaviors which either harmed or put the resident at risk of harm. The ALJ noted that Batavia did not contest the facts set forth in the CMS 2567, but argued that no deficiency should have been cited based on those facts. ALJ Decision at 13-15. (40)

According to the ALJ, Resident 39 had been assessed as at risk for falls. Nursing notes on October 1, 1998 documented that the resident was found on the floor by her bed at 12:45 AM, suffered bruises and lacerations, was hospitalized and lost some degree of ambulatory function, and was later diagnosed with a non-displaced hip fracture. Another fall was documented on November 8, 1998, with a skin tear. Six months later, nurse notes dated May 19, 23, and 27, 1999 indicate that on three separate occasions, the resident was found on the floor, with contemporaneous bruising, swelling, redness, and cuts.

The ALJ then discussed Surveyor Truett's observations from August 2-4, 1999. Surveyor Truett testified that she observed the resident reaching through unpadded side rails, placing her legs over the rail, putting her head against the rails, "thrashing about" in the bed in an agitated manner, and without the personal alarm which would alert the staff if the resident attempted to get out of bed. Ms. Truett also observed bruising and scabbing on the resident's lower extremities, which the clinical record and facility staff could not explain. The ALJ next discussed three separate incidents in May and June 1999, when the resident drank Phisohex taken from a facility treatment cart, drank from the urinal in another resident's room, and pulled a dining room stereo onto herself.

The ALJ upheld the deficiency finding, noting that the central issue was that Batavia had not properly addressed in the clinical record or care plan the need for increased supervision or interventions to prevent the resident from injuring herself. The ALJ stated that "neither Batavia nor its witnesses provided citations to documentation existing prior to the survey" to show that Batavia had created appropriate care plans or interventions. ALJ Decision at 14.

Batavia argued that the ALJ's findings should be overturned because (1) Batavia put into effect a care plan after the October and November 1998 falls which prevented another fall for six months; (2) half side rails were properly used on the resident's bed; and (3) Batavia could not care plan for events such as the resident drinking Phisohex or from another resident's urinal. Batavia also argued that one event discussed by the ALJ did not constitute a "fall." P. Reply Br. at 11.

We first address Batavia's contention that there was no finding of a "fall" when the resident was discovered on the floor on October 1, 1998. Id. Batavia did not except to the ALJ's discussion that the resident also sustained bruising and a laceration, required hospitalization, subsequently lost ambulatory function, and was diagnosed three weeks later as having a right hip fracture. Thus, whether or not this event was a "fall" (and substantial evidence supports that it was), it clearly qualifies as an "accident." The facility is to provide adequate supervision and assistive devices to prevent accidents. We find that the ALJ properly analyzed this event under this regulatory standard.

Batavia also argued that it had put care plans into effect after the resident's 1998 falls, which prevented another fall for six months. Batavia provided no citation to any document in support of this allegation, however. Contrary to what Batavia suggested, moreover, the absence of a documented fall for a six-month period does not lead a priori to the conclusion that an effective care plan must have been in place. In any event, even if such an inference were reasonable, Batavia did not document such a plan. Further, the ALJ could reasonably infer that Batavia did not continue to take adequate steps to protect this resident, given what the record shows about later incidents.

Finally, Batavia argued that it properly used the side rails on this resident's bed, which did not endanger the resident. Half rails, according to Batavia, are intended to assist the resident with bed mobility and padding them would defeat this purpose. RR at 13. Batavia further asserted that it would have been impossible for the surveyor to observe the resident's legs over the side rail, since there "was only a half rail there; there was no rail where his/her feet would be." P. Reply Br. at 11. Batavia finally argued that the resident could not become entrapped in these side rails since her head could not fit through the three inch space between the rails. RR at 14; P. Reply Br. at 11.

The ALJ noted Surveyor Truett's observation that the resident had leaned against the side rail, reaching through and over the rail with her arms to pull on the privacy curtain. ALJ Decision at 13. The ALJ Decision refers to "full unpadded side-rails raised at the head of the bed." Id. Surveyor Truett also testified that "[t]here were full length side rails on the bed, but the side rails were only raised at the head of the bed." Tr. at 50; see also CMS Ex. 34, at 137. The CMS 2567 states that "[t]he resident's legs were over the bottom of the siderails and her head was on the raised right siderail bar." CMS Ex. 4, at 25. (41) The record as a whole thus contains substantial evidence that the resident's side rail consisted of two half rails, one at the top half of the bed and the other at the lower half.

Given the above record evidence, we reject Batavia's argument that it was physically impossible for the resident to have her head resting on and her legs over the side rail. The record clearly demonstrates that the resident was small and regularly moving about in bed. It is not impossible, or even implausible, that a person of this size and level of activity could place both head and legs onto or over a half side rail raised at the head of the bed. It is also possible that the resident's legs were over the unraised lower portion of a side rail, while the head was on the "raised" upper half (as stated on the CMS 2567). It is equally possible that the resident's head was on the raised half rail on one side of the head of the bed, while her legs were over the half rail on the other side. In short, we do not agree that the surveyor's observation, as documented, was a physical impossibility that requires reversing the ALJ.

We also reject the argument that the resident could not become entrapped in the rails, since her head could not fit through bars only three inches apart. First, Batavia pointed to no evidentiary support for these dimensions. Second, other possibilities for accident by entrapment existed here, even if the resident's head could not become entrapped. A small, agitated resident is clearly at risk for injury when placing arms or legs through unpadded side rails and straining to reach a privacy curtain, as occurred here.

Finally, we reject Batavia's argument that it could not prevent or care plan for the resident drinking Phisohex (on May 25, 1999); drinking from another resident's urinal (on June 1, 1999); and pulling a stereo onto herself in the facility dining room (on June 28, 1999). The basis for this deficiency is that Batavia did not adequately address the clear need for increased supervision or interventions to ensure that this resident did not harm herself. These three events, even if unique, occurred in a one month period. Batavia pointed to nothing in the record suggesting that the facility considered these events in the context of an overall plan to supervise this resident adequately. While Batavia might not have been able to foresee the specific incidents, Batavia could reasonably foresee that this resident was at risk, if not adequately supervised.

We therefore find that the ALJ Decision, with respect to this deficiency and Resident 39, is supported by substantial evidence on the record as a whole.

Resident 164

The ALJ discussed a series of falls by Resident 164. The ALJ noted that Batavia did not dispute that the resident had been assessed as at risk for falls and that a care plan in response called for "a call light within reach, a pad on the floor beside the bed, and a personal alarm at all times." ALJ Decision at 15-16.

The ALJ then discussed a series of nurse notes, which documented four instances in which the resident was found on the floor (February 28, April 22, July 20, and July 30, 1999). During the survey, Surveyor Truett observed the resident at 8:30 AM and again at 9:00 AM "alone in his room" at the right edge of his bed, side rail down, and call button out of reach. A personal alarm was lying on the bed next to him and, according to Ms. Truett, would not have sounded had he fallen out of bed. A floor pad was partially beneath the bed, leaving portions of the bare floor exposed. At 12:50 PM, Ms. Truett also observed the resident in his wheelchair, with his call button out of reach. Ms. Truett noted that the resident's wife visited him daily until two or three o'clock. The ALJ upheld the deficiency finding as to this resident, finding that Batavia failed to consistently implement the recommended interventions.

Batavia argued that the ALJ's findings should be overturned because the resident's wife was present during the surveyor's observations, had removed the alarms, and had provided the necessary supervision absent the presence of the facility staff, and, in any event, the staff checked the resident every two hours. RR at 14-15. Batavia further argued that, except for a "scratch" in the last incident, the resident suffered no injury when found out of his bed. P. Reply Br. at 12. Batavia finally argued that there was "no indication that the resident fell out of bed," but actually was "sleeping on the matt [sic] on the floor, which is not uncommon." Id.

Batavia assessed the resident as at risk for falls at least two and a half years before the standard survey. The record contains a "Fall Prevention Protocol Policy" (Protocol) which states, in relevant part, that "[t]his policy will be followed when a resident is at high risk for falls." P. Ex. 19, at 4. Among other procedures, the Protocol calls for Batavia to "[e]nsure that call light is in reach while resident is in room." Id. It also calls for a restraint free alarm at all times, as well as a floor pad beside the bed. Id. While the Protocol contains a handwritten entry that the pad is to be used when the resident attempts to "lay on the floor," id., a July 20, 1999 nursing note describes the pad as a "safety mat." Id. at 57.

Batavia cited to no authority to support its new contention that the resident was found on the mat because he slept there. We first note Surveyor Truett's testimony that a portion, but not all, of the mat was jutting out from under the bed when she made her observation. Tr. at 57. She testified that a Batavia nurse verified that this positioning was incorrect and "fix[ed] it." Tr. at 59. Surveyor Truett also testified that the resident was documented on two separate occasions as being partially, but not wholly, on the mat. Tr. at 55. This testimony is unrebutted and is inconsistent with the idea that the resident was merely sleeping on the mat when found on the floor.

Further, the record repeatedly states that this resident fell to the floor on numerous occasions over a period of months before the survey. See P. Ex. 19, at 88, 87, 79, 57, 58 (February 27, April 22, July 20 and 30, 1999). In short, we accept the facility's own documented characterizations of the incidents as falls, and we find no basis for Batavia's argument that the resident was commonly found on the floor because he wished to sleep there.

We also note that each of these events is documented as occurring after the hours when the wife was typically present. Id.; see also CMS Ex. 4, at 26. There is thus no merit to Batavia's argument that the planned interventions did not occur solely as a result of the wife's interference. Simply put, the record supports that she was not there when these incidents occurred. Moreover, Surveyor Truett's observations were made two times when the resident was described as alone. While Batavia provided testimony that the wife usually arrived around six, Batavia presented no evidence that she had in fact arrived before the surveyor on the mornings at issue.

Batavia also maintained, for the first time, that facility staff checked the resident "every two hours as care planned regardless of whether or not the wife was present." RR at 15. It cited as support multiple pages in the resident's medical record. Id. Our review indicates that none of the cited documents support this contention. (42)

We therefore find that the ALJ Decision, with respect to this deficiency and Resident 164, is supported by substantial evidence on the record as a whole.

Resident 7

The ALJ discussed the use of a soft waist restraint for Resident 7. (43) Ms. Dunn testified that the restraint was first ordered on December 21, 1998. (44) The restraint was to be used at all times, both when the resident was in bed and when she was up in her wheelchair. The purpose of the restraint was to remind the resident to request assistance with certain transfers, as a result of her diagnosis of dementia with agitation and her history of falls. ALJ Decision at 16-18; see P. Ex. 2, at 323.

The resident was documented on July 5, 1999, as having turned over in her wheelchair, waist restraint still in place. She was subsequently taken to the hospital for suturing of a wound. Notwithstanding that the restraint held the resident in place when her wheelchair turned over, the resident nonetheless resisted wearing it. On July 16th, she attempted to cut the restraint off with a butter knife. P. Ex. 2, at 265. On July 17th and July 20th, the resident became agitated and attempted to slap facility staff or flailed her arms when they reapplied the waist restraint. Id. at 264-65. On August 4, 1999, the resident asked Surveyor Dunn to remove the restraint. Tr. at 127. Ms. Dunn testified that manufacturer instructions stated that the restraint was contraindicated for patients who resisted wearing it. Tr. at 127-28. Ms. Dunn also testified that this resident was assessed as at risk for climbing out of bed with half rails up. Tr. at 127.

The ALJ upheld the deficiency finding, stating that Batavia had not adequately addressed CMS's concerns regarding using the restraint in contravention of the manufacturer's instructions "and the possibility that, unsupervised, and unwilling to wear the waist restraints, Resident 7 was at risk for accidents." Id. at 18. Batavia argued that it attempted (1) multiple interventions in response to the resident's falls; and (2) to maintain the resident's "highest level of functional ability" by balancing safety with the resident's psychosocial, emotional, and physical concerns, medical status and changes. RR at 15. Batavia also argued that the manufacturer's recommendations do not state that the restraint should not be used on patients who resist wearing it. P. Reply Br. at 12.

We first address the issue of two sets of manufacturer's instructions. CMS submitted into evidence instructions for a "Skil-Care Cushion Belt." CMS Ex. 58. Batavia submitted into evidence a different set of instructions for a "Skil-Care Cushion Belt" (although bearing the same re-order number) and also included instructions for a Posey Restraint Product. P. Ex. 26. Batavia cited Ms. Vincent's testimony concerning manufacturer's instructions for a waist restraint for Resident 41, not Resident 7. (45) See P. Reply Br. at 12, citing Tr. 269-70.

The documentary record is unclear that the instructions submitted by Batavia for the waist restraint worn by Resident 7 would be the same instructions for the waist restraint worn by Resident 41. (46) We are disinclined to make this assumption, since (as the ALJ stated in his findings for Resident 41) "Petitioner has provided no explanation for why it offered a different set of manufacturer's recommendations than those contained in Resident 41's clinical record." ALJ Decision at 19; compare CMS Ex. 58 with P. Ex. 26.

In any event, even if Residents 7 and 41 wore the same restraint and those restraints had the same manufacturer's instructions, the record reflects conflicting testimony as to which of the two sets admitted by the ALJ into evidence were relevant. Surveyor Dunn testified that the manufacturer's instructions for Resident 7 state that the restraint was contraindicated for a resident who attempted to remove it. Tr. at 128. Batavia witness Rebecca Vincent testified they do not contain any such statement. Tr. at 270. (47) After hearing this testimony, the ALJ found that Batavia had not sufficiently addressed CMS's concerns that it used the restraint in contravention of the manufacturer instructions. ALJ Decision at 18. The ALJ thus accepted Ms. Dunn's testimony over that of Ms. Vincent. As we have long held, in questions of witness credibility, we generally defer to the findings of the ALJ, and we do so again in this instance. Meadow Wood Nursing Home v. CMS, DAB No. 1841, at 8 (2002), quoting South Valley Health Care Center, DAB No. 1691, at 22 (1999), aff'd South Valley Health Care Center v. HCFA, 223 F. 3d 1221 (10th Cir. 2000)(citations omitted).

The central issue is that a restraint insufficiently protects against the risk of accident when the resident regularly attempts to remove it. ALJ Decision at 18. The record amply demonstrates that the resident resisted wearing this device. We find no fault with the ALJ's conclusion that "Resident 7 was at risk for accidents." Id.

Batavia also argued that it assessed and made changes to the resident's care plan on ten occasions from July to November 1999, in response to multiple falls. RR at 15. Batavia listed several of those interventions, with citations to the resident's medical record. Id., citing P. Ex. 2, at 325-330. The ALJ also analyzed this argument and found that most of the cited material was created after the survey and as a response to surveyor concerns. ALJ Decision at 18, n.6. The ALJ noted that the only relevant document, dated July 12, 1999, ordered that the soft waist restraint not be applied during meal times and, then, only when the resident was supervised. Id. After reviewing the record, we affirm this analysis.

Batavia also maintained that the balance between resident safety and helping the resident achieve her highest functional level requires a complex analysis of multiple factors, including psychosocial, emotional, physical, and family components. RR at 15. However difficult this task may be, we note that it is a task performed by facilities nationwide each day, and we find that this argument is insufficient to excuse a facility that ignored safety warnings in the instructions for an assistive device. Batavia is obligated, as a requirement of participating in the Medicare program, to provide adequate supervision and assistance devices to its residents in order to prevent accidents. The record supports that it failed to comply substantially with this requirement.

We therefore find that the ALJ Decision, with respect to this deficiency and Resident 7, is supported by substantial evidence on the record as a whole.

Resident 41

The ALJ discussed the use of a soft waist restraint for Resident 41. A May 7, 1999 "Plan of Care for Physical Restraint/Enabler" in the medical record calls for "soft waist restraint at all times," with both side rails up when in bed. P. Ex. 6, at 29. A July 15, 1999, handwritten entry on a physician's order sheet again called for a soft waist restraint at all times. P. Ex. 6, at 2. (48) A Posey soft belt was to be used when he was up in his chair, a "skill core roll belt" to be used in the bed. Id.; ALJ Decision at 18-20. (49)

On May 21, 1999, records indicate that the resident was found on the floor in front of his wheelchair, "restraint untied." P. Ex. 6, at 56. On August 2, 1999, the surveyor observed the resident wearing the restraint in bed, with the bottom portion of the left side rail not raised completely or locked into position. On August 5, 1999, the surveyor observed the resident alone in his room, with the restraint untied as he sat in his wheelchair. ALJ Decision at 19.

The ALJ admitted into evidence manufacturer instructions offered by CMS. Tr. at 278-80; CMS Ex. 58. The instructions are for a "Skil-Care" belt and state that the belt is intended as a "gentle reminder" for patients not to leave the wheelchair or bed and that it is not intended for those patients who, among other things, "actively attempt to remove safety devices." Id. The instructions further state that when the belt is worn in bed, the caregiver should "[a]lways make certain that the bed rails are in the raised position before leaving patient." Id.

As previously discussed with respect to Resident 7, the record also contains manufacturer instructions offered into evidence by Batavia for a "Skil-Care" cushion belt and for a "Posey" soft belt, and safety instructions for use of "Posey Restrictive Products." P. Ex. 26. None of these instructions contain the statement that the restraint is contraindicated for patients who "actively attempt to remove" devices. Id.; see also Tr. at 270 (testimony of Batavia witness Rebecca Vincent) and supra p. 50, n.47.

The ALJ upheld the deficiency finding, stating that Batavia had not rebutted the surveyor's observation that side rails were not in place and that the restraint was untied. ALJ Decision at 19. The ALJ further found Batavia's arguments concerning the manufacturer's instructions and family satisfaction unavailing. Id. Batavia argued that (1) the half side rail was down for meal service; (2) the restraint could be untied by the resident as it was meant as a reminder not to ambulate without assistance; (3) the resident sustained no injuries from the documented fall; (4) the restraint was the least restrictive intervention; and (5) the family was satisfied with the restraint and voiced no complaint about Batavia's care. RR at 16-17. Batavia further argued that the manufacturer's recommendations do not state that the restraint is contraindicated for residents who attempt to untie it. P. Reply Br. at 12.

We affirm the ALJ's finding that Batavia failed to rebut CMS's allegations that the siderails to the resident's bed were not in place, as ordered by the physician and called for by the manufacturer. The physician's order dated April 29, 1999, states: "side rails up x 2 at all times d/t forgets unable to ambulate without assist d/t alzheimers w/ cognitive impariment [sic], R&R Q 2hrs check 2 30 mins." P. Ex. 6, at 7. (50) Surveyor Dunn noted at 9:15 AM and again at 4:44 PM on August 2, 1999, that the bottom rail on the left side of the resident's bed was not secured in place. Batavia did not deny these observations, but explained that the surveyor's observations occurred during "meal time." However, Batavia cited to no evidence that the resident was or had recently finished eating at the time of the surveyor observation or even that the resident took his meal in his room, rather than the facility dining room. Batavia's unsupported assertion regarding "meal time" is insufficient to overturn the ALJ's findings.

We also affirm the ALJ's finding that Batavia failed to rebut CMS's allegations that the restraint was untied on August 5, 1999. Batavia argued that the cushion was not intended as a restraint, but as a gentle reminder to the resident to ask for assistance. This assertion cannot reasonably be seen as consistent with the April 29, 1999 physician's order, which refers to the order as a restraint order. P. Ex. 6, at 7. The resident had a diagnosis of Alzheimer's disease and would forget that he was unable to walk without assistance. As a result, the physician ordered not only the waist restraint, but that side rails of the resident's bed be raised at all times to prevent the resident from leaving the bed. We cannot agree that the resident, an Alzheimer's patient who could not remember that he could not walk alone with a history of hip fracture, should be permitted to untie a restraint to free himself from a chair.

We also affirm the ALJ's finding that Batavia offered no explanation as to why it offered a different set of instructions than CMS. ALJ Decision at 19. We find that the ALJ could reasonably have accepted CMS's explanation that its set of manufacturer's instructions came from Resident 41's medical record. See CMS's Reply to Petitioner's Post-Hearing Brief at 6, n.3. We also find that Batavia used the waist restraint in contravention of those instructions, which stated that the assistive device should not be used for patients who "actively attempt[ed] to remove" it. CMS Ex. 58.

We further reject Batavia's arguments that the resident suffered no injury and that the family had no complaints concerning care. First, the regulatory standard does not require that an injury occur before a facility has failed to comply substantially with its requirements. The standard requires that the facility provide supervision and assistance devices for accident prevention in accordance with the plan of care. The absence of documented bodily harm does not exculpate the facility from failing to do so. Second, we agree with the ALJ that the fact that a family may actively monitor a resident's care and not register a specific complaint does not obviate the federal standard.

We therefore find that the ALJ Decision, with respect to this deficiency and Resident 41, is supported by substantial evidence on the record as a whole.

FFCL 5. As of the revisit survey ending on September 29, 1999, Petitioner remained out of compliance with the participation requirement at 42 C.F.R. 483.25(h)(2) (F Tag 324 on the CMS 2567 dated September 29, 1999).

A nursing home's obligations regarding supervision and assistance devices to prevent accidents are set forth in our previous discussion for FFCL 4. See 42 C.F.R. 483.25(h)(2).

The revisit survey indicated that Batavia remained out of substantial compliance with certification requirements. CMS Ex. 16, at 1. The CMS 2567 reflects F-Tag 324 deficiencies for Residents 61, 81, and 161. CMS Ex. 15, at 7-11. Batavia did not challenge the facts on which CMS relied for its prima facie cases in the CMS 2567. We provide a brief summary of the deficiencies and ALJ findings as background.

Resident 61 had difficulty ambulating and was documented on more than one occasion as found on the floor. A restraint free alarm did not alert staff. Id. at 8-9. The ALJ found that Batavia failed to address why it did not implement a different intervention or device in response. ALJ Decision at 20-21.

Resident 81 was also documented on multiple occasions as found on the floor. The CMS 2567 also reflects that planned interventions for a call light within reach and a raised right side rail were not consistently implemented. CMS Ex. 15, at 9-10. The ALJ found that Batavia had failed to identify and implement effective interventions to prevent falls. ALJ Decision at 21-22.

Resident 161 was documented as either having been lowered to or found on the floor. The resident expressed reluctance to walk, as a result of her falls. Her medical records did not indicate either a comprehensive or immediate needs care plan in response to the resident's falls. CMS Ex. 15, at 10-11. The ALJ found that Batavia did not implement a care plan which would respond to the three falls that had occurred over a four-day period. ALJ Decision at 23.

CMS determined that the F-Tag 324 deficiency during the revisit survey constituted a repeat of the same deficiency from the standard survey. CMS Ex. 15, at 11. CMS further determined that Batavia failed to implement the POC that it had prepared in response to the standard survey. Id.

The ALJ upheld the deficiency finding, stating that Batavia had not rebutted CMS's prima facie cases. ALJ Decision at 21, 23. Batavia argued that the ALJ committed clear error because "he analyzed the wrong resident records and related evidence." RR at 17. According to Batavia, Residents 61, 81, and 161 in the revisit survey were not the same Residents 61, 81, and 161 in the standard survey. Thus, argued Batavia, the ALJ analyzed records and evidence for the wrong residents and "[a]ccordingly, the facility should prevail." RR at 17. Batavia also argued that the CMS 2567 includes examples of deficient practices that occurred prior to Batavia's allegation of substantial compliance as of September 20, 1999. P. Reply Br. at 12-13. Thus, Batavia "should not be cited for events that occurred during that period of time." Id. at 13. As discussed below, both of these arguments fail.

The ALJ properly identified Residents 61, 81, and 161 in the revisit survey.

We first address the "wrong resident" argument. Batavia maintained that the ALJ erroneously relied upon evidence concerning Residents 61, 81, and 161 from the standard survey to make his findings for the revisit survey. RR at 17. It provided as an example the ALJ citation to testimony by Rebecca Vincent who, Batavia maintained, "did not testify about the follow-up survey, only the initial survey." Id. In fact, Ms. Vincent did testify about the revisit survey, challenging CMS's description of Resident 61 as bored and opining that CMS's deficiency finding was inconsistent with Resident 61's behavior. Tr. at 276; CMS Ex. 15, at 9.

Other than its unfounded argument about Ms. Vincent's testimony, Batavia provided no other basis for its position that "the facility should prevail" as a result of the purported misidentification. The record, however, contains ample evidence that there was no misidentification. The CMS State Operations Manual provides that before beginning an initial survey, state surveyors pre-select a sample of residents upon which to focus. See generally SOM Appendix P, Task 4; see also Tr. at 31 (testimony of Surveyor Truett regarding sample selection). This "Phase 1" sample is finalized after the surveyors' initial tour of the facility, when the facility then provides resident identification information either on a Roster/Sample Matrix (Form HCFA-802) or "some other format (e.g., computer-generated list)." SOM Appendix P at P-18. Due to privacy and confidentiality concerns, "resident identifiers" are used on the CMS 2567. Id. at P-76. These identifiers can be "a code number the survey team has assigned to each resident in the sample." Id. at P-76 through 77.

As with the initial survey, surveyors must also select a resident sample for a revisit survey. Id. at P-73, citing SOM Table 1 (Resident Sample Selection). CMS advises that the revisit sample focus on residents "who are most likely to have those conditions/needs/problems cited in the original survey." Id. Notably, the SOM does not suggest that the residents in the revisit sample consist of the same residents in the initial sample. In short, revisits can focus on different individuals.

With this background, it is apparent that ODH did not (and was not required to) identify residents in the resurvey using identifiers from the standard survey. The list generated for the revisit identifies Residents 61, 81, and 161 by their first names and the initial of their last names. See CMS Ex. 43. (51) Resident Review Worksheets (RRWs) also identify the residents this way. CMS Ex. 41, at 30, 15, 62. The findings documented by Ms. Truett on the respective RRWs are consistent with those documented in the revisit CMS 2567. The findings documented in the revisit CMS 2567 are consistent with those in the ALJ Decision. We therefore find that the CMS 2567 and the ALJ Decision correctly identify the residents in the revisit survey. We further find that the ALJ relied upon the correct records in reaching his conclusions on these residents.

We further find that Batavia either knew or had reason to know who these residents actually were and has shown no prejudice in its ability to have presented rebuttal evidence before the ALJ. First, Batavia itself submitted a POC that responded to the cited deficiencies. In the POC, Batavia asserted that "Residents #61, 81, and 161 had their Plan of Care reviewed and revised for appropriate interventions on October 1, 1999." CMS Ex. 15, at 8. The POC continues in greater detail, showing that Batavia unquestionably knew the identity of these residents. (52) Given the facility's own POC, we find Batavia's "wrong resident" argument wholly insufficient to overturn the ALJ's findings.

Accordingly, we affirm the ALJ's findings concerning Residents 61, 81, and 161 in the resurvey.

Batavia was not in substantial compliance with program requirements after alleging compliance as of September 20, 1999.

Batavia also argued that the ALJ Decision should be overturned because the ALJ includes in his findings examples of noncompliance occurring before the date Batavia alleged was the date on which it achieved substantial compliance - September 20, 1999. P. Reply Br. at 12-13.

The CMS 2567 shows that Batavia submitted a POC with a September 20, 1999 "target date" for implementation. CMS Ex. 4 passim. Evidence regarding Batavia's allegation of substantial compliance, however, would not be sufficient to establish that Batavia in fact achieved substantial compliance as alleged. Regulations provide that providers must submit POCs in response to survey findings of noncompliance for approval by the state survey agency. 42 C.F.R. 488.402(d), 488.408(f). However, nothing in the regulations suggests that completion of the POC establishes conclusively that the facility has achieved substantial compliance. Instead, the regulations provide that substantial compliance must be established by a resurvey or after an examination of credible written evidence produced by the facility (which could be verified without an onsite visit). 42 C.F.R. 488.454(a)(1). Moreover, as we have previously noted, the preamble to the regulations adopting the present enforcement scheme clearly indicates that compliance with a POC is not conclusive evidence of substantial compliance with program requirements. Warren N. Barr Pavilion of Illinois Masonic Medical Center, DAB No. 1705, at 9 (1999), citing 59 Fed. Reg. 56,203 (Nov. 10, 1994). However, the CMS State Operations Manual points out that "[s]urveyors should focus on what has occurred since correction dates [contained in the POC]; a determination of noncompliance is not based on problems which took place during the correction period." SOM 7317A.1.

ODH verified Batavia's allegations of substantial compliance, effective October 1, 1999, during a follow-up survey on October 21, 1999. However, the record reflects that Batavia was not in substantial compliance during the September 29, 1999 revisit survey, shown by incidents occurring after Batavia alleged compliance on September 20th. With respect to Resident 61, the ALJ detailed incidents occurring on September 27th and 29th. ALJ Decision at 20-21. As to Resident 81, the ALJ discussed incidents occurring on September 24th, 28th, and 29th. ALJ Decision at 21-22. Regarding Resident 161, the ALJ recounted incidents occurring on September 22nd, 24th, and 25th. ALJ Decision at 23. As previously mentioned, Batavia presented no rebuttal evidence.

We thus conclude that these incidents alone support the ALJ's conclusion, since "even one isolated instance of non-compliance having a potential for more than minimal harm may be the basis for a finding that the petitioner is not substantially complying with the applicable participation requirement." Ridge Terrace, DAB No. 1834, at 6 (2002), citing Lake City Extended Care Center, DAB No. 1658 (1998). Moreover, the ALJ committed no error by noting incidents occurring prior to September 20, 1999, in reaching his findings of fact and conclusions of law. The incidents occurring prior to September 20 were relevant in determining what the facility knew about the residents' risk of falls, even if the determination of noncompliance must rest on Batavia's continuing failure after that date to meet the regulatory requirements.

FFCL 6. The amount of the CMP imposed against Petitioner by CMS, $33,600, is reasonable.

The ALJ concluded that the $600 per day CMP imposed by CMS was reasonable in amount. In reaching this conclusion, he cited to 42 C.F.R. 488.438(f) and to the Board's decision in CarePlex of Silver Spring, DAB No. 1683, at 8 (1999) as the standards guiding his analysis. ALJ Decision at 24. He noted that the amount of the CMP imposed was at the lower end of the range for deficiencies of this type ($50 - $3,000), that there were repeat deficiencies, and that the deficiencies were serious, causing actual harm to the residents. Id. He further stated that Batavia provided no evidence on its financial condition, "other than a brief reference to information provided to CMS witness Tim Weidler reflecting a net operating loss and negative shareholder's equity." Id., citing Batavia Nursing and Convalescent Center's Posthearing Brief (posthearing brief or P. Br.) at 9.

Batavia argued that CMS "failed to prove" that a basis existed for imposing the CMP and that the survey history of the facility and its financial condition rendered the amount of the CMP unreasonable. RR at 17. Batavia also raised the same general points made to the ALJ, which were addressed. See P. Br. at 9; RR at 18; P. Reply Br. at 13.

In CarePlex, we stated that "an ALJ's assessment of a CMP's reasonableness must be guided in part by the factors specified in 42 C.F.R. 488.438(f)." Livingston Care Center, DAB No. 1871, at 23 (2003), citing CarePlex of Silver Spring, DAB No. 1683 (1999). Those factors consist of "a facility's history of noncompliance (including repeated deficiencies)," its financial condition, factors set forth in 42 C.F.R. 488.404, (53) and the culpability. 42 C.F.R. 488.438(f). Culpability includes, without limitation, "neglect, indifference, or disregard for resident care, comfort or safety." 42 C.F.R. 488.438(f)(4). Neglect, in turn, "means failure to provide goods and services necessary to avoid physical harm, mental anguish, or mental illness." 42 C.F.R. 488.301. The absence of culpability is not a mitigating factor used to reduce the CMP.

We first reject Batavia's argument that the ALJ has no basis for imposing a CMP. As we stated in Livingston Care Center, the facility "simply asserts that what we and the ALJ have found not to be true, namely, that it" was in substantial compliance with program requirements. DAB No. 1871, at 25 (2003). We have affirmed the ALJ's findings that Batavia was not in substantial compliance with program requirements from the standard survey through September 30, 1999. As a result, we find that the ALJ had a sufficient basis for upholding the imposition of a CMP.

Batavia next argued that the facility had a "reasonably good history" of compliance with program requirements. RR at 18; P. Reply Br. at 13. In support, it cited the direct testimony of CMS official Timothy Weidler, who reviewed the facility's prior survey results before imposing the $600 per day CMP. Tr. at 180. Mr. Weidler testified as follows:

Q: What did the Oscar report indicate to you about the facility's compliance?

A: We did review the Oscar reports detailing previous survey results for the facility.

Q: What did those survey results indicate?

A: They noted that Batavia had a reasonably good history.

Q: Of compliance?

A: Of compliance.

Tr. at 180. (54) Mr. Weidler testified that "the key factors" in CMS's decision to affirm the recommended CMP "were that there were four G level deficiencies with multiple residents suffering actual harm with some of that harm being of a serious nature and that we felt the facility was culpable in that these deficiencies should have been prevented." Tr. at 182.

In reviewing the facility's compliance history, the ALJ noted that "[i]n this case there is a repeat deficiency." ALJ Decision at 24. "[R]epeated deficiencies" are identified in the regulation as an example of what should be considered in assessing a facility's history of noncompliance. 42 C.F.R. 488.438(f)(1). Regulations in effect at the time of the survey provide that "repeated deficiencies are deficiencies in the same regulatory grouping of requirements found at the last survey, subsequently corrected, and found again at the next survey." 42 C.F.R.  488.438(d)(3)(1998). (55)

Our review indicates a lack of substantial evidence to support that Batavia had a repeated deficiency. Mr. Weidler's testimony concerning the OSCAR reports does not indicate that Batavia had past Level G deficiencies that it had corrected before again falling out of substantial compliance with that regulatory grouping during the standard and revisit surveys. The Level G deficiency found in the revisit survey cannot be properly classified as a "repeated deficiency," as Batavia had not corrected the Level G deficiencies from the standard survey before the revisit survey.

We find, however, that the absence of substantial evidence to support the existence of a repeated deficiency is not material to the outcome of the ALJ's analysis. Mr. Weidler's uncontroverted testimony is that CMS considered Batavia's history of noncompliance by reviewing OSCAR reports in affirming the recommended CMP. We find no fault with CMS's consideration of a "reasonably good history of compliance" as one factor in assessing a CMP at the lower end of the required range. Batavia presented no evidence to indicate that its survey history, as one such analytical factor, did not warrant the imposition of any CMP. Instead, it relied solely upon Mr. Weidler's testimony to rebut CMS's prima facie case. We find this testimony insufficient as a basis for reversing the ALJ.

We thus find that the ALJ could have reasonably determined that Batavia had a history of noncompliance that was sufficient as one factor in the analysis to sustain the CMP imposed.

Batavia then argued that its financial information demonstrates a net operating loss and negative shareholder's equity from January 1999 to August 1999. RR at 18; P. Reply Br. at 13. The ALJ noted, however, that Batavia cited to no evidence regarding its financial condition, other than "brief reference to information" concerning a net operating loss and negative shareholders' equity. ALJ Decision at 24.

As in its subsequent filings, Batavia asserted in its posthearing brief that "information provided to Mr. Weidler reflected a net operating loss in excess of $330,000 for the period from January 1 through August of 1999. That information also reflected negative shareholder's equity in excess of $329,000." P. Br. at 9, citing Tr. at 185-6. The hearing transcript reveals that this financial information was supplied by Batavia's counsel during cross-examination. Tr. at 185. Mr. Weidler responded to leading questions that he "believed" counsel's characterizations to be accurate. The transcript does not reflect that Batavia offered any documents into evidence, and it offered none on appeal.

As we have held, the ALJ need consider "only those factors for which the parties submitted evidence." Livingston Care Center, DAB No. 1871 at 25 (2003), citing Emerald Oaks, DAB No. 1800 (2001) (finding that CMS need not offer evidence concerning the regulatory factors as part of its prima facie case). The record reflects that Mr. Weidler considered an "income statement report prepared by the Ohio medicaid agency" when assessing Batavia's financial condition and imposing the $600 per day CMP. Tr. at 181. According to Mr. Weidler, that income statement indicates that Batavia was profitable as of the end of 1998. Id.; see CMS Ex. 11, at 1 (1998 cost report shows $734,903 profit). Medicaid cost report information also shows a profit of $289,302 for 1999. CMS Ex. 11, at 2.

In Wisteria Care Center, the facility claimed an inability to pay the $1,000 per day CMP imposed and provided testimonial evidence from the owner and documentary evidence in the form of Medicaid cost reports in support. The ALJ found that the evidence submitted did not demonstrate the facility's inability to pay the CMP, nor had the owner testified that "a CMP of $1,000 per day would put the facility out of business." The record did not reflect that the facility submitted into evidence any "written information . . . concerning its assets or overall financial condition. . . ." We found that the ALJ "expressly considered the evidence submitted . . . but found it unilluminating and not credible." Wisteria Care Center, DAB No. 1892, at 12 (2003).

We conclude similarly here. Except for leading questions posed upon cross-examination (with equivocal responses from the witness), Batavia submitted no documentary or testimonial evidence supporting its contention that Batavia sustained a net operating loss and negative shareholder's equity during 1999. Batavia also provided no evidence concerning the nature of its assets or liabilities, which could illuminate the negative results cited by counsel. Further, Batavia did not argue that it is financially unable to pay the $600 per day CMP. In contrast, the record contains information based upon Medicaid cost reports that reflect unadjusted net operating profits of $734,903 and $289,302, respectively, for Batavia during 1998 and 1999. This evidence eviscerates Batavia's unsupported contentions. In short, the ALJ concluded that Batavia had not proffered evidence sufficient to modify the CMP based on financial condition. We affirm this conclusion.

Batavia also argued that the ALJ made no finding regarding facility culpability. However, Batavia did not challenge the ALJ's findings that the facility in some instances ignored physician orders or its own care plans. Further, CMS concluded that the deficiencies cited caused actual harm to the residents, "a result that, in our view, reflects some degree of culpability." Livingston Care Center, DAB No. 1871 at 25 (2003), citing 42 C.F.R. 488.438(f)(4) (providing a non-exclusive definition of culpability that includes disregard for resident care or safety).

Accordingly, we affirm FFCL 6.

Conclusion

For the above reasons, we affirm the ALJ Decision in its entirety and sustain the CMP (totaling $33,600) imposed in this case. In doing so, we affirm and adopt all of the FFCLs made by the ALJ.


JUDGE
...TO TOP

Cecilia Sparks Ford

Donald F. Garrett

Judith A. Ballard
Presiding Board Member

FOOTNOTES
...TO TOP

1. CMS was previously named the Health Care Financing Administration (HCFA). 66 Fed. Reg. 35,437 (July 5, 2001).

2. A "deficiency" is defined as a skilled nursing facility's "failure to meet a participation requirement" set forth in the Social Security Act or in 42 C.F.R. Part 483. 42 C.F.R. 488.301.

3. Surveyors gather information during compliance surveys through personal observation, interviews, and medical record review. SOM Appendix P, Task 5, at P-24 through 27. CMS advises surveyors to document information on forms that include "Surveyor Notes Worksheet" (HCFA 807) and "Resident Review Worksheet" (HCFA 805). Id. at P-14, 30. CMS advises surveyors that "[t]his documentation will be used both to make deficiency determinations and to categorize deficiencies for severity and scope." Id. at P-25.

4. This decision may refer to both a facility's Plan of Correction and a resident's Plan of Care as "POC," as context requires.

5. "The purpose of the remedies is to ensure prompt compliance with program requirements." 42 C.F.R. 488.402(a).

6. "Seriousness" is assessed by determining "(1) Whether a facility's deficiencies constitute - (i) No actual harm with a potential for minimal harm; (ii) No actual harm with a potential for more than minimal harm, but not immediate jeopardy; (iii) Actual harm that is not immediate jeopardy; or (iv) Immediate jeopardy to resident health or safety. (2) Whether the deficiencies - (i) Are isolated; (ii) Constitute a pattern; or (iii) Are widespread." 42 C.F.R. 488.404(b).

7. The absence of culpability is not a mitigating circumstance in reducing the amount of the CMP. 42 C.F.R. 488.438(f)(4).

8. See "Request for Review and Brief in Support of Petitioner Batavia Nursing and Convalescent Center of Decision CR-1031, Rendered by Administrative Law Judge Richard J. Smith on April 16, 2003," for Docket No. C-00-196, Decision No. CR-1036, and dated June 19, 2003.

9. We note that Batavia has not been prejudiced by any lack of notice concerning the burden of proof as applied in the ALJ hearing. To the contrary, Batavia had notice that it bore the burden of proof, by a preponderance of the evidence, since the ALJ stated this in the order and notice setting the hearing. "Order and Notice of Hearing," dated August 7, 2000, ALJ Hearing Record, Part I.

10. A "rule" is defined, in relevant part, as "the whole or part of an agency statement of general or particular applicability and future effect designed to implement, interpret, or prescribe law or policy or describing the organization, procedure, or practice requirements of an agency . . . ." 5 U.S.C. 551(4).

11. The Seventh Circuit declined to address Hillman challenges concerning rulemaking, the APA, and applicability to CMP cases because the evidence was not in equipoise and because the Board therefore had not provided a comprehensive analysis of the issues. Id. As later discussed, the evidence is clearly not in equipoise in this case on the issue of whether Batavia was in substantial compliance. However, Petitioner's Request for Review raises yet again the issues for which the Seventh Circuit requested the Board's analysis, as well as related issues, and the parties have sufficiently addressed those issues in their pleadings. We thus resolve those issues here. Cf. Georgian Court Nursing Center, DAB No. 1866, at 11-12, n.10 (2003); Milpitas Care Center, DAB No. 1864, at 19-20 (2003).

12. We note that, even if either the APA or section 205(a) of the Act required that the burden of proof be set by rule using notice and comment procedures (and we find that they do not), the issue before the ALJs and the Board in an individual case is how to allocate the burden in the absence of a rule so promulgated. Hillman and its progeny reflect an examination of the relevant Medicare statute and regulations, during adjudication, to reach a result consistent with their language and purpose.

13. Batavia also argued, more narrowly, that the statute concerning termination of provider agreements implicates the hearing provisions of section 205(b) of the Act (42 U.S.C. 405(b)). RR at 5, citing 42 U.S.C. 1395cc(h)(1) (section 1866(h)(1) of the Act). This is true, but irrelevant here. Congress elected to address hearings on CMPs not through section 1866(h)(1) of the Act, but through section 1819(h)(2)(B)(ii) (42 U.S.C. 1395i-3(h)(2)(B)(ii)). That section cross-references certain subsections of section 1128A of the Act (42 U.S.C.  1320a-7a), which apply to CMPs "in the same manner as such provisions apply to a penalty or proceeding under section 1320a-7a(a) . . . ." 42 U.S.C. 1395i-3(h)(2)(B)(ii). Those subsections in turn set forth procedures for a hearing when a CMP is the chosen remedy, including the right of the affected party "to be represented by counsel, to present witnesses, and to cross-examine witnesses against the person." 42 U.S.C. 1320a-7a(c)(2). Neither section 1819 nor section 1128A references section 205 or specifically addresses burden of proof.

14. Batavia cited Pulido v. Heckler, 568 F. Supp. 627 (D. Colo. 1983) and Salling v. Bowen , 641 F. Supp. 1046 (W.D. Va. 1986) as examples of cases requiring an agency to promulgate regulations pursuant to section 205(a) of the Act. RR at 6. The Pulido court required the Secretary to promulgate regulations governing payment of certain travel expenses of benefit claimants. The Salling court struck down a Social Security pilot program creating agency advocates for disability hearings, as it had not been promulgated by regulation after the pilot period ended. Both cases are fact intensive, involve different regulatory structures, and involve Social Security disability benefits to individuals, not issues about provider participation in Medicare. They are inapposite to the instant case.

15. Batavia uses the terms "burden of proof" and "burden of persuasion" interchangeably throughout its Request for Review. As discussed in Hillman, the term "burden of proof" can mean either burden of production (going forward) or ultimate burden of persuasion. The term "burden of proof" in the APA refers to the burden of persuasion. Director, OWCP v. Greenwich Collieries, 512 U.S. 267, 276 (1994). We use the term burden of proof here to mean burden of persuasion.

16. This allocation is consistent with the Court's recognition that in Social Security disability cases, the claimant carries the "continuing burden of showing" satisfaction of statutory requirements. Mathews v. Eldrige, 424 U.S. 319, 336 (1976).

17. Section 1866(a) sets out requirements for provider agreements. Having a provider agreement is not enough to qualify for program participation, however. The lead-in language to section 1866(a)(1) states: "Any provider of services . . . shall be qualified to participate . . . and shall be eligible for payments . . . if it files with the Secretary an agreement . . . ." (Emphasis added.) The definition of "provider of services" for purposes of Medicare includes a "skilled nursing facility." Section 1861(u) of the Act. Section 1861(j) of the Act defines a "skilled nursing facility" by cross-reference to the term in section 1819(a) of the Act. The definition in that section in turn provides that, among other things, to qualify as a skilled nursing facility, an institution (or distinct part of an institution) must meet the requirements of section 1819, relating to provision of services, residents' rights, administration, and other matters. The survey and certification process is the means for determining whether these requirements are met. Because some nursing facilities participate in both Medicare and the Medicaid program (providing for grants to States to provide medical assistance to needy individuals), section 1819(g)(1) of the Act now sets out the relative federal and state responsibilities in the survey and certification process, pursuant to an agreement under section 1864 of the Act. Under section 1819(g)(2), each skilled nursing facility shall be subject to a "standard" survey, to be conducted without any prior notice to the facility, initially and not later than 15 months after the date of the previous standard survey. A facility may also be subject to "extended" or "partial extended surveys" or to complaint investigations.

18. Specifically, section 1819(g)(2) of the Act provides:

(C) CONTINUATION OF PAYMENTS PENDING REMEDIATION.-- The Secretary may continue payments, over a period of not longer than 6 months after the effective date of the findings, under this title with respect to a skilled nursing facility not in compliance with a requirement of subsection (b), (c), or (d), if-
(i) the State survey agency finds that it is more appropriate to take alternative action to assure compliance of the facility with the requirements than to terminate the certification of the facility,
(ii) the State has submitted a plan and timetable for corrective action to the Secretary for approval and the Secretary approves the plan of corrective action, and
(iii) the facility agrees to repay to the Federal Government payments received under this subparagraph if the corrective action is not taken in accordance with the approved plan and timetable. . . .

(Emphasis added.)

19. A CMP is one of several alternative remedies available to CMS for a facility's noncompliance with program requirements. A CMP does not possess the punitive characteristics akin to a "fine or sanction" by other statutes or regulations. As we have noted, the purpose of a CMP "is not to punish individual violations but to pursue attainment and maintenance of a state of substantial compliance with federal requirements." Regency Gardens Nursing Center, DAB No. 1858, at 11 (2002).

20. Both Merritt and Bosma predate the Supreme Court decision in Greenwich Collieries and do not clearly reflect the Court's distinctions between burdens of production, persuasion, and proof.

21. Indeed, the Hillman court noted that the APA arguably did not apply at all, given the allocation of the burden of proof implicit in the Medicare statutes. Id. at 27, n.9.

22. The Supreme Court has endorsed a review of an agency's "early decisions, the purpose and legislative history of [the governing statute], the Board's subsequent and consistent construction of the Act . . . , and the decisions of the courts of appeals" in affirming an agency's interpretation of its governing statute. NLRB v. Bell Aerospace, 416 U.S. 267, 289 (1974). The analytical approach taken in Hillman reflects these standards.

23. See "The Reply Brief of Petitioner Batavia Nursing and Convalescent Center," dated August 7, 2003.

24. CMS may, but is not required to, select a Category 2 remedy for deficiencies at Levels D and E. 42 C.F.R.  488.408(d)(3); SOM 7400E.1.

25. Mimiya Hospital, DAB No. 1833, at 8 (2002), aff'd, Mimiya Hospital v. Dep't of Health and Human Servs., No. 02-1952 (1st Cir. June 9, 2003).

26. CarePlex of Silver Spring, DAB No. 1683, at 17 (1999).

27. While there are a few instances where the ALJ does not fully discuss all of the evidence relied on by Batavia or miscited record pages, his ultimate findings and conclusions are supported by substantial evidence in the record as a whole, as discussed below.

28. Batavia's argument is silent on the remainder of the statutory provision requiring that a facility provide or arrange for the provision of pharmaceutical services, dietary services, an on-going activities program, certain dental services, and treatment for the mentally ill and mentally retarded (to the extent not provided by the State). 42 U.S.C.  1395i-3(b)(4)(A)(iii-iv).

29. After initially declining, the resident agreed to emergency transport to the hospital 30 minutes later.

30. Even if good cause had been shown (and it has not), the proffered document is not material. Batavia stated that the progress note calls into "question[] the cause of the sepsis because the resident had an infiltrate noted on chest x-ray and a urinary tract infection." RR at 8. First, this record does not explain why the facility failed to notify the physician of the foul, green drainage for two days after its onset. Second, the progress notes are largely illegible, but even if they can be read as calling into question the cause of the sepsis, they do not call into question the existence of the sepsis.

31. The correct record citation on the resident's fall is P. Ex. 1, at 87.

32. Batavia cited to Petitioner's Exhibit 1, at 6 in support of its assertion that "the non-portable x-ray found that there was no injury from the fall." P. Reply Br. at 9. The cited document is a May 21, 1999 Interdisciplinary Plan of Care which, logically, does not report the results of the August x-ray. We note that Batavia's incorrect citations are not infrequent and reflect an indifference to accuracy.

33. The ALJ Decision does not cite to the medical record for Resident 154, which is found at P. Ex. 17.

34. Our Guidelines provide that we "will review only those parts of the record before the ALJ which are cited by the parties or which the Board considers necessary to decide the appeal." Guidelines, 4(c).

35. In addition to the right heel wound, the record demonstrates that this resident was susceptible to and suffered from pressure sores in multiple areas, both before and after the survey. For example, facility forms titled "Pressure Ulcer Progress Reports" document sores on the left heel (P. Ex. 20, at 67), right toe (id. at 69), coccyx (id. at 70), and left ear (id. at 73). The only area at issue in this deficiency is the right heel. CMS Ex. 4, at 17-18.

36. The ALJ pointed out that the SOM defines a "pressure sore," in part, as an "ischemic ulceration and/or necrosis of tissues overlying a bony prominence subjected to pressure, friction or shear." ALJ Decision at 10-11, n.4, citing SOM Appendix PP, at PP-93; see also Tr. at 33-34 (testimony of Surveyor Truett). (The term "ischemic" means related to or affected by "deficiency of blood in a part, due to functional constriction or actual obstruction of a blood vessel." Dorland's Illustrated Medical Dictionary 857 (27th ed. 1988).). Pressure sores are categorized in one of four stages. SOM Appendix PP, at PP-93. A Stage II pressure sore is described as a partial loss of skin thickness "that presents clinically as an abrasion, blister, or shallow crater." ALJ Decision at 49, n.4. Batavia did not object to this description. Batavia's form "Pressure Ulcer Progress Report" also includes blistering as an indication of a Stage II pressure ulcer. See, e.g., P. Ex. 20, at 67. We thus accept the surveyor's assessment of the right heel ulceration as a pressure sore, notwithstanding the description as a "blister" in facility documents.

37. See "The Centers for Medicare & Medicaid Services's Response to Batavia Nursing and Convalescent Center's Request for Review and Brief in Support Thereof," dated July 18, 2003.

38. Our review of the record did not reveal any August 4, 1999 nurse documentation of a "brown drainage with a black area noted at the sore site," as described in the CMS 2567. Batavia did not directly rebut the statement, however. Moreover, the surveyor's notes indicate that the nurse treating the area was writing on a paper towel, so the reference was not necessarily to nurse documentation in the official record.

39. Even if the physician's observations related to the debridement indicate that some healing had occurred due to the measures implemented in July (and we make no such finding), this does not rebut the evidence that the facility failed to provide all the interventions it planned to promote healing.

40. The ALJ Decision does not cite to the medical record for Resident 39, which is found at P. Ex. 4.

41. Batavia described the resident as "very tiny

. . . frequently agitated, physically aggressive, and [she] would flail her arms and legs." P. Reply Br. at 11. The resident was 5'3" and weighed 90 pounds during the surveyor's observation. P. Ex. 4, at 2.

42. A document titled "Status of Core Care Plan Goals" indicates that the wife visited daily. P. Ex. 19, at 6. A document titled "Interdisciplinary Team Conference Report," for assessment period May 21-26, 1999, sets forth planned interventions. Id. at 7. Two documents titled "Additional Comments/Recommendations/ Summary," one dated after the survey, again document that the wife visited daily. Id. at 8, 10. A September 2, 1998 entry on a document titled "Status of Core Care Plan Goals" documents that the wife visited daily. Id. at 13. Nurse notes dated August 13-25, 1999, say nothing about the staff involvement that Batavia argued and, occurring after the standard survey, are irrelevant in any event. Id. at 56. A document titled "Comprehensive Nurses Summary," dated "4/99," says nothing about either the wife or the staff. Id. at 62. None of these documents mention staff checks every two hours. In short, Batavia's citations to the record leave its argument utterly unsupported.

43. A description of a soft waist device is contained in the ALJ Decision at 16, n.5.

44. The ALJ Decision states that Ms. Dunn's record review showed the restraint order on December 21, 1999. Id. 17. Ms. Dunn's testimony actually indicates that the restraint was ordered in December 21, 1998. Tr. at 124; see also P. Ex. 2, at 341 (same date physician order for waist restraint). The record reflects that these orders were discontinued on the last day of the standard survey. P. Ex. 2, at 296.

45. Batavia provided no citation to a document that would be instructions for the waist restraint worn by Resident 7.

46. See discussion concerning Resident 41, infra pp. 51-54.

47. Neither set of instructions submitted by Batavia (for the Skil-Care and Posey restraints) specifically states that the restraint is contraindicated for a resident who attempts to remove it. P. Ex. 26. However, the instructions for the Posey belt list the following contraindications: "Aggressive, combative, restless, or suicidal patients who do not receive constant monitoring." P. Ex. 26, at 3. These instructions continue: "The patient may become restless or agitated if the device is uncomfortable or severely limits movement. Request assistance from a qualified medical authority for an alternative product or intervention." Id. The instructions for the "Skil-Care" belt provide an alternative application method for a resident who "easily unties it." Id. at 1. Batavia did not assert that such an alternative method was used for Resident 7.

48. We note that this order sheet was dated as reviewed by Lisa Hall, RN, on July 28, 1999 (before the survey), although not dated as signed by the physician until August 18, 1999 (after the survey).

49. Petitioner's Exhibit 6 indicates that the plan for the type of device was "Rewritten 9-24-99," after the survey. P. Ex. 6, at 29. Thus, it is unclear whether the plan specified more than a "soft-waist restraint" prior to that date. Physician's orders indicate that the physician ordered a "PT screen for appropriate restraint device" on August 5, 1999 (after the surveyor's observations) and, on August 12, 1999, specified a Posey soft belt for wheelchair usage and a "Skillcare rollbelt" while in bed. Id. at 10. The earlier order was just for a "soft waist restraint at all times" with side rails to be "upx2". Id. at 29.

50. Manufacturer instructions for the Skil-Care belt placed into evidence by CMS state that the caregiver must "[a]lways make certain that the bed rails are in the raised position before leaving patient." CMS Ex. 58 ("Bed Application," #5). Manufacturer instructions for the Skil-Care belt placed into evidence by Batavia omit this statement. P. Ex. 26, at 1 (see "Bed Application"). Safety warnings for the Posey belt placed into evidence by Batavia state: "all side rails MUST be in the up position when using restraints. If necessary, use a side rail cover, or gap ptotector [sic], especially with split side rails, to prevent the patient's body from going under, around, through or between the siderails." P. Ex. 26, at 2 (capitals in original).

51. Residents 61, 81, and 161 on the resident identifier list for the revisit survey have different names than the identically numbered residents on the list for the standard survey. Compare CMS Exs. 43 and 35.

52. An "Addendum to the Plan of Correction" states:

Resident #61 had a post fall assessment completed and a pressure sensitive pad for her bed and chair at all times was initiated on September 30, 1999. Resident #81 was assessed through the post fall assessment and she now utilized a restraint free alarm at all times. She was placed in a restorative amubulation [sic] program. We have also added a bath mat in front of her toilet for more grip while standing. Resident #161 had her slippers replaced allowing more traction. Staff spoke with her regarding the use of the call light when she feels she needs assistance.

CMS Ex. 15, at 12.

53. This regulation requires an analysis of the "seriousness" of the deficiency. Livingston Care Center, DAB No. 1871, at 24 (2003). "Seriousness" is measured by the scope and severity of the cited deficiencies. Id. The ALJ found the deficiencies here to be at a severity level of actual harm, but did not clearly reference their scope. In making its determination, CMS referred to the most serious deficiencies as being actual harm, but "isolated" (the most limited scope). CMS Ex. 24, at 1. We therefore conclude that the ALJ's omission is not material and would not affect the amount of the CMP.

54. The SOM provides that CMS may consider, as one factor in assessing the amount of a CMP, "[f]acility specific reports maintained in the Online Survey, Certification and Reporting System [OSCAR] from the current survey and the past three surveys." SOM 7516B.1.b.

55. CMS recently issued a final rule which, as a technical correction, restored the definition of "repeated deficiencies" to subsection (d) of 42 C.F.R. 488.438. 68 Fed. Reg. 46,036, 46,067 (August 4, 2003). The definition was originally published on November 10, 1994, and inadvertently omitted during and subsequent to republication in the Federal Register on March 18, 1999. Id.

CASE | DECISION | ANALYSIS | JUDGE | FOOTNOTES