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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 Inn,

Petitioner,

DATE: March 1, 2004

             - v -

 

Centers for Medicare & Medicaid Services

 

Docket No. A-03-76
Civil Remedies CR1027
Decision No. 1911
DECISION
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FINAL DECISION ON REVIEW OF
ADMINISTRATIVE LAW JUDGE D
ECISION

Batavia Nursing and Convalescent Inn (Batavia or Petitioner) appealed an April 18, 2003 decision by Administrative Law Judge Jose A. Anglada (ALJ) affirming the determination by the Centers for Medicare & Medicaid Services (CMS) (1) to impose a civil money penalty (CMP) against Batavia for failure to comply substantially with certain Medicare participation requirements. Batavia Nursing and Convalescent Center, DAB CR1027 (2003)(ALJ Decision). The ALJ upheld a reduced CMP in the amount of $600 per day for the period "from October 20, 2000 through December 13, 2000." (2) ALJ Decision at 1.

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

Background

This is a companion case to the Board's decision in Batavia Nursing and Convalescent Center, DAB No. 1904 (January 14, 2004)(Batavia I), which involved the same facility, but a different time period. In both cases, the facility has been represented by the same counsel, who filed requests for review and supporting briefs (individually, a Request for Review or RR) for both cases on the same date. The Requests for Review raise identical legal challenges concerning the burden of proof and other general issues and fact-specific challenges to the ALJ's FFCLs. The analysis of the legal challenges here is virtually identical to that in Batavia I, reflecting the identical issues in the Requests for Review. See Batavia I at 6-27.

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), (3) which identifies and discusses each alleged failure by the facility to meet a participation requirement. See CMS State Operations Manual (SOM) Appendix P, § IV. (4) 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) (5) 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 § 7203.D. "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 with those requirements. (6) 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). (7) 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. 2, at 1. In determining the choice of a remedy within a remedy category, CMS may consider factors that include, without limitation, "[t]he relationship of the one deficiency to other deficiencies resulting in noncompliance" and "[t]he 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 repeated 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). (8) 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) completed a standard survey at Batavia on October 20, 2000 (standard survey). CMS Ex. 1, at 1. As a result, ODH cited Batavia for multiple deficiencies, the most serious being two isolated deficiencies at Level G, which caused actual harm that was not immediate jeopardy: F-314 (pressure sores) and F-324 (accident prevention). Id. at 36, 45. ODH also cited Batavia for three deficiencies at Level B, one at Level C, eleven at Level D, thirteen at Level E, and one at Level F. See CMS Ex. 1.

On October 30, 2000, ODH advised Batavia that it would recommend certain remedies for the deficiencies, including a CMP of $700 per day (effective October 20, 2000). CMS Ex. 2, at 2. Batavia submitted a POC on November 10, 2000, which stated that Batavia would achieve substantial compliance with the deficiencies as of December 8, 2000. CMS Ex. 9; see also SOM § 7317A (POC as allegation of compliance).

ODH conducted a "follow-up survey on December 13, 2000" (revisit survey) and verified Batavia's allegations of substantial compliance, effective December 13, 2000. CMS Ex. 6. On January 9, 2001, CMS imposed a CMP of $37,800 ($700 daily, from October 20, 2000 through December 12, 2000). CMS Ex. 8, at 2. (9)

The ALJ Decision

On January 11, 2001, Batavia requested an ALJ hearing, disputing ODH's determination that Batavia had not been in substantial compliance with program requirements and challenging the imposition of a CMP. CMS Ex. 10, at 2. Batavia then challenged the factual bases for all deficiencies cited and argued that it did not have the financial resources to "support a monetary penalty." Id. at 2. An evidentiary hearing before ALJ Anglada was held April 16-17, 2002. Hearing Transcript (Tr.) at 297, 490.

The ALJ Decision contains 21 numbered FFCLs under Section IV.A. (10) ALJ Decision at 5-45. In virtually all instances, the FFCLs address deficiencies covered by CMS in its post-hearing brief. See ALJ Decision at 2, n.4, and 9, and Centers for Medicare and Medicaid Services Post-Hearing Brief, Docket No. C-01-317, dated June 17, 2002. Section IV.B. of the ALJ Decision addresses the reasonableness of the amount of the CMP. ALJ Decision at 45-46. In Section IV.A., the ALJ upheld CMS's findings of noncompliance for nineteen deficiencies (FFCLs 1, 3-16, 18-21), (11) reversed CMS's findings of noncompliance for two deficiencies (FFCLs 2, 17), (12) and did not address ten deficiencies. (13) Even where he upheld CMS's findings, the ALJ did not analyze all examples cited in the CMS 2567. See CMS Ex. 1. The ALJ reduced the CMP from $700 to $600 per day, as he found that CMS failed to establish all deficiencies cited. ALJ Decision at 46.

Issues

Batavia's Request for Review (14) 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)(hereinafter, "Hillman"), aff'd, Hillman Rehabilitation Center v. U.S., No. 98-3789 (GEB)(D.N.J. May 13, 1999), 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 (Act) also required publication of a rule on burden of proof. RR at 5-6. In addition, Batavia maintained that it had prevailed on all deficiencies and other findings not addressed in the ALJ Decision. RR at 6. Finally, Batavia challenged all FFCLs made by the ALJ, except those in which the ALJ found in Batavia's favor. RR at 7-27.

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, at 2 (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 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 deficiencies and other findings not addressed in the ALJ Decision. We continue by discussing whether substantial evidence and applicable law supports the ALJ's determinations in FFCLs 1, 3-16, and 18-21. We conclude by discussing 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). (15)

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 a 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). (16) 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); NLRB V. Bell Aerospace, 416 U.S. 267, 293 (1974).

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 (42 U.S.C. § 1395cc(h)(1)). 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. U.S., 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 at 13, n.10.

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. Dept. of Health and Human Svcs., 300 F.3d 835, 840, n.4 (7th Cir. 2002), on appeal from Fairfax Nursing Home, Inc., DAB No. 1794 (2001)(hereinafter, "Fairfax"), cert. denied 537 U.S. 1111 (2003). (17)

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 at 8 ("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. (18)

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. (19)

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]." 42 U.S.C. § 1395ii.

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(h)). Batavia did not point to any decisions applying section 205(a) to provider participation requirements, rather than to Medicare beneficiaries' rights, however. (20)

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. RR at 3, citing 5 U.S.C. § 556(d). (21)

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 at 12-17. 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 at 17.

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). (22) 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. (23) 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. (24) 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. (25) 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 (2nd 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. (26) 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 at 12-17. 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). (27) 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 at 18 ("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 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 at 18 (citations omitted). (28) When enacting the Nursing Home Reform Act, Congress did not revise this standard, and "congressional failure to revise or repeal the agency's interpretation 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),(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 5-7. (29) However, 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. 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 at 13, n.10.

Further, 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 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 of the findings of deficiencies made by CMS, including all F-tags and all residents cited." RR at 6. Batavia maintained that since the ALJ failed to find that CMS had made a prima facie case with respect to unaddressed deficiencies and certain findings regarding residents under other tags, then Batavia "prevails on those findings," even under the disputed Hillman standard. Id. at 7. Batavia argued that a determination must be made regarding the "residual life" of those deficiencies. Reply Br. at 8.

CMS's determination to impose a CMP of $700 per day was based upon the findings of the state survey agency, which concluded that Batavia had failed to comply substantially with 31 requirements for participation. The ALJ found that Batavia failed to comply substantially with 19 requirements, resulting in two Level G deficiencies, seven Level D deficiencies, and ten Level E deficiencies. (30) The ALJ determined that a reasonable amount for the CMP was $600 per day, as "CMS did not establish all of the deficiencies charged . . . ." ALJ Decision at 46.

The regulations mandate that CMS select a Category 2 remedy for Level G deficiencies, which may include a CMP in the range of $50 - $3000. (31) 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 $700 per day (subsequently reduced by the ALJ to $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 and other findings by CMS is not tantamount to findings in favor of Batavia on those points. 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? (32) (3) Was the amount of the CMP reasonable? (33)

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 in this case. 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). We conclude below that the ALJ properly found that Batavia was not in substantial compliance with the deficiencies upon which he made express findings and that were appealed by the parties. CMS was thus 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. The aggregate amount of the CMP is consistent with the duration of Batavia's lack of substantial compliance. In its November 14, 2000 "Notice of Imposition of Remedies," CMS informed Batavia that it would impose a $700 per day CMP (effective October 20, 2000) until either Batavia achieved substantial compliance with program requirements or its provider agreement was terminated. CMS Ex. 5, at 1-2. The revisit survey on December 13, 2000, revealed that Batavia had attained substantial compliance with program requirements as of December 13, 2000, and ODH notified Batavia that it would advise CMS to impose a $700 per day CMP effective October 20, 2000. CMS Ex. 6. CMS ultimately imposed a CMP in the aggregate amount of $37,800, constituting a $700 per day CMP for the period October 20 through December 12, 2000. CMS Ex. 8, at 2. 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. Batavia first asserted that the CMP was "not appropriate" since "CMS failed to prove that Batavia was not in substantial compliance. . . ." RR at 27. Batavia subsequently maintained that "the ALJ erred in finding . . . that the $600 per day CMP was reasonable." Reply Br. at 20. As discussed below, we affirm the ALJ's conclusion "that the imposition of a CMP of $600.00 per day is reasonable," even without considering the additional deficiencies alleged by CMS. (34) ALJ Decision at 46.

In summary, we find that CMS had a basis for imposing a CMP based on the deficiencies cited in the standard survey. 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 related to the 19 deficiencies upheld in the ALJ Decision. We additionally find that the amount of the CMP is reasonable under the relevant regulatory criteria, even without considering the additional deficiencies and other CMS findings. Accordingly, the ALJ was not required to address in his decision all deficiencies, and all examples in support of deficiencies, cited by ODH during the standard survey when he affirmed the imposition of a 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. at 8. 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.

As stated above, we uphold an ALJ decision when it is supported by substantial evidence and free of legal error. See supra p. 7. Substantial evidence is "relevant evidence" which a reasonable person "might" accept to reach the conclusion drawn. Id. 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. (35)

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. (36) 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 8. 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 8. 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.

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 14 (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: Cathy Henson (personnel director, former housekeeping supervisor)(Tr. at 371-72), Mary Palmer (former administrator)(Tr. at 380-82), Amy Boehm (social worker)(Tr. at 387-89), Rebecca Vincent (licensed practical nurse)(Tr. at 402-03), Tamela Lewis (registered nurse)(Tr. at 419-20), Carol Watson (licensed practical nurse)(Tr. at 429-30), and Kimberly Parks (regional director for health care consulting firm)(Tr. at 436-37). The ALJ also heard testimony on the qualifications of the state surveyors, CMS witnesses Debbie Truett (Tr. at 24-28), Vince Borrell (Tr. at 200-02), Fran Tucker (Tr. at 247-49), and Sami Guttery (Tr. at 328-30).

Absent clear error, we defer to the findings of the ALJ on weight and credibility of testimony. Koester Pavilion at 15. 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.

FFCL 1. Notification of Rights and Services (Tag F157). The facility failed to notify the physician immediately after a significant change in the condition of Resident #122 (R122).

A facility's obligations regarding notification of changes in a resident's condition are set forth in 42 C.F.R. § 483.10(b)(11), which provides, in relevant part, as follows:

A facility must immediately . . . consult with the resident's physician . . . when there is . . . (B) A significant change in the resident's physical, mental, or psychosocial status (i.e., a deterioration in health, mental, or psychosocial 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) . . . .

The ALJ Decision addresses Resident 122.

Resident 122

The ALJ discussed the resident's hallucinations that bugs were crawling on and under her skin and the facility's purported failure to immediately consult the physician. ALJ Decision at 5-6. The ALJ noted that the symptoms began on September 20, 2000, and were ongoing through September 27. According to the ALJ, on September 27, the physician was notified of the "hallucinatory experiences" and ordered interventions consisting of hand mitts and a new medication. Id. at 6. The ALJ framed the central issue as whether the September 20, 2000, hallucinatory symptoms qualified as "a significant departure from those previously experienced, regardless of whether the symptoms arise from a new condition or a previously existing one." Id. at 7.

Batavia argued on appeal that CMS erroneously assumed that the hallucinations were "associated with" the administration of an anti-psychotic drug. Batavia asserted instead that the resident's longstanding delusional disorder, diagnosed in October 1995, caused the hallucinations. Batavia also maintained that the facility had developed a POC in response and that the physician had seen the resident on September 20. RR at 8-9.

We agree with the ALJ that the onset of hallucinations for the resident on September 20, 2000, was, standing alone, a significant change in condition warranting immediate physician consultation. The physician's response of changing the medication regimen supports the CMS view as to the cause of the hallucinations. In any event, the central issue is the onset of the hallucinations and the facility's response. The record is devoid of any documentation of hallucinatory experiences before September 20.

Batavia next argued that "there was no need to notify the physician [because] he was present in the facility" on September 20. Batavia maintained that the physician was "notified again" of the change in condition on September 27, when the resident began to harm herself by picking at her flesh. RR at 9. In support of this argument, Batavia offered the testimony of consultant Kimberly Parks, who testified that the physician "was actually in the facility" on September 20, "so he was notified." Tr. at 438. She stated that she had "observed" in the clinical record a progress note signed by the physician on September 20. Id. (37) After referencing that document during the hearing, she then testified that the physician was "there that day and saw that [hallucinatory] behavior. . . ." Tr. at 440.

ODH surveyor Fran Tucker testified that the physician was not notified of the hallucinatory experiences until September 27, seven days after onset. Tr. at 252-53. This statement is supported by her review of a facility record, which she documented in her notes as follows: "Res [complains of] bugs crawling all over me. . . . [No] phy[sician] notification in [change] in res condition." CMS Ex. 22, at 15.

We conclude that the ALJ could reasonably have accepted Ms. Tucker's testimony, as informed by her facility record review, over the testimony of Ms. Parks. Other than Ms. Parks' testimony, there is no record evidence to support that the physician saw Resident 122 on September 20. While Ms. Parks referred to a progress note signed by the physician on September 20, the ALJ reviewed that document at the hearing and found the entry illegible. Tr. at 441. Moreover, Ms. Parks did not allege that she was in the facility or in direct contact with the physician on September 20. We are unable to conclude, based on the record as a whole, that she had first-hand knowledge of the facts underlying her testimony. We generally defer to the findings of the ALJ in questions of witness credibility, and we do so again in this instance. Meadow Wood at 8, quoting South Valley at 22 (citations omitted).

We finally note that Ms. Parks also testified that the physician was notified again on September 27 when the resident's flesh-picking behavior actually began to harm her. RR at 9; Tr. at 439-40. (38) We reject any implication that notification was not required until there was actual physical harm to the resident. The regulation requires physician notification when there is a significant change in the resident's condition. As stated, we affirm the ALJ's conclusion that the onset of the hallucinations on September 20 constituted such a significant change and triggered the notification requirement.

Batavia also presented other arguments, all of which we conclude are tangential and insubstantial. We therefore do not specifically address them in this discussion.

Accordingly, we affirm FFCL 1.

FFCL 2. Free Choice (Tag F164). CMS did not establish that the facility failed to ensure that a resident receive personal privacy.

The ALJ found that CMS failed to establish a prima facie case under this participation requirement. ALJ Decision at 10. CMS did not appeal this finding, which we leave undisturbed.

FFCL 3. Grievances (Tag F166). The facility failed to provide prompt efforts to resolve grievances the residents may have.

A facility's obligations regarding resolution of resident grievances are set forth in 42 C.F.R. § 483.10(f), which provides, in relevant part, as follows: "A resident has the right to . . . [p]rompt efforts by the facility to resolve grievances the resident may have . . . ." (39) The ALJ Decision addresses resident complaints concerning food quality, beautician services, and lack of attendance by administration at resident council meetings. ALJ Decision at 10-12; see CMS Ex. 19, at 19-20.

Batavia did not contest that the facility failed to have an administration representative attend resident council meetings, as requested by the council. ALJ Decision at 10-11; CMS Ex. 19, at 20 ("Council suggested someone from administration attend meetings but no one comes."). Nor did Batavia claim it had taken any other measures to address the grievance. We therefore summarily affirm that uncontested finding.

Batavia also did not dispute the factual findings of the ALJ with respect to food quality and beautician services, but argued instead that the ALJ erroneously interpreted those facts and made unsupported assumptions. We disagree.

Batavia did not dispute the fact of the residents' food complaints (documented by the surveyor as follows: "Food is garbage. Meats tough. Substitutes are leftovers. . . . Used to have a food committee but dietician cancelled [without] reason. Facility told about concerns but do nothing. . . ." CMS Ex. 19, at 19). Instead, Batavia argued that only a small number of residents complained. RR at 11. This argument ignores that the surveyor interviewed a sample of facility residents and does not rebut that the facility failed to respond to complaints raised. Batavia did not assert or provide any evidence that a greater number of residents would have had a different view.

We also find unpersuasive Batavia's arguments that the surveyor only once observed food left on plates after a meal and that the causative factor in that instance may have been flu vaccinations, which Batavia speculated are usually given in the fall. Id. The point is not whether the complaints were warranted, but whether Batavia promptly responded. Batavia pointed to no evidence showing any response to the complaints.

CMS also cited Batavia for failing to provide onsite beautician services from early October through November 7, 2000. ALJ Decision at 11-12; CMS Ex. 19, at 20 ("Res. very upset that beautician left a month ago and has not been replaced.") Batavia did not contest that residents were without onsite beautician services for approximately five weeks. Batavia's central argument, instead, was that the delay resulted from lack of notice of resignation by the former beauticians. Batavia also argued that it arranged for interim beautician services at a nearby affiliated facility. RR at 10, citing Tr. at 385-86; Reply Br. at 9, citing 385-86. (40)

Batavia did not demonstrate that it took reasonable and prompt measures to replace the beauticians after their departures. Batavia was not writing on a clean slate when it replaced the departing beauticians in the fall of 2000. The former administrator testified that Batavia had run a newspaper advertisement for a replacement beautician in the spring of 2000. Tr. at 384. Like the ALJ, we note the lack of any similar advertisement in the record for the fall replacement (or any testimony concerning such an advertisement). The facility beauticians left, purportedly abruptly, at the first of October. A replacement began work approximately five weeks later, on November 8, 2000 (little more than two weeks after the survey). Tr. at 385. Thus, the ALJ could reasonably find that Batavia did not take "prompt efforts" to resolve the complaint until after the deficiency was cited. See ALJ Decision at 11-12.

We have considered the rest of Batavia's arguments regarding this deficiency finding and find them insufficient to overturn the ALJ.

We thus affirm FFCL 3.

FFCL 4. Quality of Life (Tag F246). The facility failed to ensure that residents have the right to receive services in the facility with reasonable accommodations of individual needs and preferences.

A facility's obligations regarding resident quality of life (accommodation of needs) are set forth, in relevant part, at 42 C.F.R. § 483.15(e)(1), which provides:

A resident has the right to - (1) Reside and receive services in the facility with reasonable accommodation of individual needs and preferences, except when the health or safety of the individual or other residents would be endangered . . . .

The ALJ discussed how differences in dining room table and wheelchair sizes and designs prevented 45 residents from getting close enough to their plates to bring food to their mouths without spillage. ALJ Decision at 12-13.

Batavia argued on appeal that the standard or typical dimensions of a wheelchair permitted sufficient proximity to the table. Batavia further argued that CMS had never cited the facility for poorly sized tables in the past and had thus waived its ability to do so now. RR at 11; Reply Br. at 10.

Batavia's arguments lack merit. The deficiency finding was based on the surveyor's observation of 45 wheelchair bound residents spilling food on themselves while eating in the dining room. The surveyor specifically noted that their wheelchairs prevented them from getting closer to their plates. ALJ Decision at 13; Tr. at 204-05. Batavia argued that the "standard length of a wheelchair arm is thirteen inches," which, Batavia claimed, resulted in "a perfectly comfortable distance to have the plate away from the body in order to eat." RR at 11-12. However, Batavia provided no evidentiary support for its claim about the arm length or to show that, contrary to the surveyor's observation, the distance was comfortable for its residents.

We also reject Batavia's assertion that CMS "waived" the ability to cite this deficiency, since table and chair size had not changed over a period of 25 years. RR at 11; Tr. at 446-47. Batavia cited to no authority which holds that CMS is precluded from issuing a citation for a deficiency simply because CMS had not cited it previously. See Westgate Healthcare Center, DAB No. 1821, at 24 (2002). In any event, the finding was not based solely on the table height, but on there being a substantial number of residents whose access to their food was hampered because they were in their wheelchair. The surveyor observation remains undisputed that the wheelchairs and dining room tables in use at the time of the survey hampered resident access to food on the table, resulting in spillage as the residents attempted to eat. We find that this constitutes substantial evidence that the facility had not provided reasonable accommodations for the needs of these residents.

We therefore affirm FFCL 4.

FFCL 5. Social Services (Tag F250). The facility failed to provide medically-related social services to attain or maintain the highest practicable mental well-being of each resident.

A facility's obligations regarding quality of life (social services) are set forth, in relevant part, at 42 C.F.R. § 483.15(g)(1), which provides:

The facility must provide medically-related social services to attain or maintain the highest practicable physical, mental, and psychosocial well-being of each resident.

The ALJ Decision addresses Residents 96 and 182.

Resident 96

The ALJ described how the facility failed to provide medically related social services for Resident 96 to address grief over her recent change in condition to "terminal" (with a change in code to "do not resuscitate") and the loss of her daughter years before. ALJ Decision at 14-15.

On appeal, Batavia repeated arguments addressed by the ALJ, that the hospice to which the resident was referred had developed a POC that responded to the resident's needs. RR at 12, citing P. Ex. 7, at 5. As the ALJ pointed out, Batavia provided no documentary evidence of a hospice POC in effect at the time of the survey, instead citing a POC started by the facility in 2001, after the survey. ALJ Decision at 15.

Batavia also argued, as it had before the ALJ, that Petitioner's Exhibit 7 provides evidentiary support that notwithstanding the purported hospice POC, Batavia itself developed a social services POC. RR at 12. As the ALJ pointed out, the POC at Petitioner's Exhibit 7 is dated July 17, 2001, over nine months after the survey ended, and is thus irrelevant. ALJ Decision at 15; P. Ex. 7, at 5.

Batavia finally argued that its "care plan in place for cognition and depression" (41) addressed Resident 96's grief issues by "asking her to verbalize her feelings." RR at 13, citing Tr. at 449; Reply Br. at 10. In support, Batavia's counsel pointed to an entry in Surveyor Tucker's notes under the "heading . . . emotional/psycho social status." Tr. at 306. Contrary to counsel's assertion, our review indicates that the above reference is not a "heading," but the completion of an entry from the preceding line, which reads in its entirety as follows: "padded [siderails] - use of device will not result in [decrease] in physical, emotional/psychosocial status . . . ." CMS Ex. 22, at 21 (emphasis added); Tr. at 306-07. (42)

Based on the evidence of record, we find that the ALJ reasonably concluded that "the facility did nothing to assist R96 through grief from learning that she had only six months or less to live." ALJ Decision at 15.

Resident 182

The ALJ discussed significant weight loss by Resident 182 and the social worker's failure to respond to the family's request for a meeting to discuss feeding tube or hospice options. ALJ Decision at 14-15. Batavia argued on appeal that the facility had discussed these options with the family before the request for a meeting and that the family failed to respond to later follow-up contacts from Batavia and ultimately refused tube placement. RR at 13.

The documents relied upon by Batavia indicate that on October 4, 2000, a facility representative discussed with the resident's granddaughter the use of IV fluids in the short-term and tube feeding versus hospice care as long-term options if the resident's appetite did not improve. P. Ex. 6, at 7, 11. The representative then referred the granddaughter "to social worker for questions re: hospice." Id. at 7. An October 10 entry reflects that the granddaughter had spoken with the social worker and desired a meeting to discuss the resident's status and options. The entry also stated that the granddaughter would contact her mother (the resident's daughter who had power of attorney) "to schedule meeting." Id.

ODH surveyor Debbie Truett testified that the social worker indicated that she did nothing to follow up on the request for a meeting because she was not comfortable discussing feeding tubes. Tr. at 133. Ms. Truett also testified that (i) the social worker would not necessarily have had to answer questions, but that she should have coordinated and worked with family and nursing and dietary to ensure that the resident received prompt and appropriate services that best met resident needs; (ii) there were no notes showing such coordination, although it is common for social workers to get involved in such issues; and (iii) the social worker's failure had the potential to delay treatment and allow further declines in the resident's weight and hydration status. Tr. at 132-35.

Batavia offered no documentary or testimonial evidence from the social worker concerning a response to the October 10 request. Batavia cited instead testimony by consultant Kimberly Parks to support that the facility made unsuccessful attempts to contact the family. RR at 13 and Reply Br. at 11, citing Tr. at 462. The cited testimony makes no reference to any such attempts. (However, nurse notes prior to October 10 show some unsuccessful attempts at contacting the family and after October 10, that the facility notified the family of new physician orders. P. Ex. 6.) The testimony of Ms. Parks that the family ultimately refused feeding tube placement is insufficient to establish that the social worker responded in a timely manner to the family's request for a meeting to discuss options or otherwise sought to coordinate the services.

We therefore affirm FFCL 5.

FFCL 6. Environment (Tag F253). The facility failed to provide housekeeping and maintenance services necessary to maintain a sanitary, orderly, and comfortable interior.

A facility's obligations with respect to the resident's environment are set forth, in relevant part, at 42 C.F.R. § 483.15(h)(2), which reads: "The facility must provide . . . [h]ousekeeping and maintenance services necessary to maintain a sanitary, orderly, and comfortable interior . . . ." Id. The ALJ Decision addresses Resident 6. (43)

Resident 6

The ALJ found that a dusty, dirty fan had been permitted to blow air directly onto a resident with a tracheostomy. ALJ Decision at 16. Batavia argued on appeal that this finding should be reversed, since the resident wore a "trach mask . . . at all times" and fans were cleaned pursuant to a weekly schedule. RR at 13-14; Reply Br. at 11, citing Tr. at 362. We find Batavia's arguments insufficient to overturn this FFCL.

The CMS 2567 reflects that on two successive days, the surveyor observed a fan "noted to have a thick layer of gray dust" on its blades blowing directly onto Resident 6. CMS Ex. 1, at 15. Resident 6 had a compromised respiratory system and a tracheostomy. Id. ODH surveyor Sami Guttery testified that a tracheostomy is "an opening into the wind pipe that allows the resident to breathe." Tr. at 335. (44) Ms. Guttery also testified that there was no filter between the outside air and the inside of this resident's trachea. Id.

In support of its position, Batavia cited to more than ten days (and nine pages) of nursing entries to establish that the patient wore a "trach mask" which, according to Batavia, "covers the trach and provides an aerosol over the trach." RR at 13-14, citing P. Ex. 14, at 9-17. Batavia pointed to no one entry in those pages to support its contention that the mask covered the tracheostomy. The notes do refer to a physician's order for a trach aerosol mask (and the notes for October 12 refer to providing oxygen and humidification "via trach mask.") However, the notes by themselves do not clearly establish that the mask was on at all times, including at the time of the surveyor's observation, or that the mask would not have permitted the resident to breathe in the outside air.

We also find unpersuasive Batavia's reliance upon the facility's housekeeping schedule and the testimony of the former housekeeping supervisor as evidence that the fan did not contain a thick layer of gray dust on October 18 and 19, as reported by the surveyor. RR at 13-14, citing P. Ex. 28. Our review of the entire schedule reveals no reference to the regular cleaning of fans in Resident 6's room, however. While the cleaning supervisor testified that the fans were on a weekly cleaning schedule, and that housekeeping staff did "pull all the fans and re-clean them," she also said that the staff on the wings "check [the fans] and if they need cleaning, they clean them." Tr. at 373.

The ALJ could reasonably find that the schedule and testimony offered fail to rebut Ms. Guttery's direct observation of an uncleaned fan blowing directly onto the resident with a tracheostomy. As we have noted before, "having a full-time housekeeping staff as well as policies and procedures for cleaning and maintaining the facility does not satisfy the requirement that the facility actually be kept clean and orderly." Crestview Parke Care Center, DAB No. 1836, at 12 (2002)(emphasis in original).

We therefore affirm FFCL 6.

FFCL 7. Professional Standards of Quality (Tag F281). The facility failed to provide services that met professional standards of quality.

A facility's obligations with respect to comprehensive care plans are set forth, in relevant part, at 42 C.F.R. § 483.20(k)(3)(i), which reads: "The services provided or arranged by the facility must - [m]eet professional standards of quality. . . ." The ALJ Decision addresses Residents 122 and 6.

Resident 122

The ALJ discussed how the facility failed to conduct followup bloodwork ordered by the physician. The surveyor's record review indicated that initial bloodwork on May 11, 2000, revealed an elevated calcium level. The physician then discontinued the resident's calcium supplement. Follow-up bloodwork on May 26 revealed that the calcium level was still high. The physician ordered another calcium test in one month. ALJ Decision at 17-18; CMS Ex. 22, at 16. Batavia witness Rebecca Vincent testified that this follow-up bloodwork was not done. ALJ Decision at 18; Tr. at 405.

Batavia argued that the ALJ's finding should be reversed because the physician saw the resident "in June and the physician chose not to reorder the calcium level test." RR at 14. Medical records reveal no physician orders or nursing entries for May or June. P. Ex. 4. There is thus no documentary evidence to support Batavia's suggestion that the physician actually saw the resident in June or in some manner rescinded the May 26 order. Moreover, we see no reason why, as Batavia suggested, a physician would need to "re-order" an order already given to trigger a facility's obligation to act.

As we have noted (and Batavia has not contested), compliance with physician orders is a part of meeting professional standards. Emerald Oaks, DAB No. 1800, at 37 (2001). Substantial evidence supports the ALJ's finding that Batavia failed to do so here.

Resident 6

The ALJ discussed how the facility failed to provide a laxative ordered "as needed" for Resident 6, who had a history of constipation. The surveyor testified that a review of the medical records indicated that Resident 6 had two bowel movements during a two-week period (on October 8 and 9, 2000), which were preceded by a one-time administration of the prn (45) laxative Dulcolax (on October 7). The ALJ concluded that Batavia's failure to administer the prn laxative at other times ignored both the resident's need and the physician's remedy. ALJ Decision at 17-18, citing Tr. at 337-38; P. Ex. 14, at 2.

Batavia argued that the fact that the resident tolerated tube feeding well "indicat[ed] that the resident was not in fact constipated." Batavia also argued that the ALJ "failed to consider" that the resident was receiving a second laxative daily. RR at 14.

Batavia provided no support for its first assertion, that a lack of contraindication to tube feeding means that the resident could not have been constipated. By contrast, the record contains an "Acute Plan of Care" for the "problem/need constipation" put into effect on October 8, 2000. P. Ex. 14, at 2. We also find that the ALJ amply considered and addressed the fact that the resident had two medication prescription orders for constipation, both dated May 15, 2000. ALJ Decision at 18, citing P. Ex. 14, at 3. A Dulcolax suppository (also referred to as Bisacodyl) was to be provided "daily as needed for constipation," while Enulose (also referred to as Lactulose) was to be provided "per J-tube daily [for] constipation." P. Ex. 14, at 3. The ALJ noted that "[t]he record is clear that the physician prescribed both laxatives, yet there is evidence of only a one time administration [of Dulcolax] . . . . " ALJ Decision at 18. The ALJ concluded that notwithstanding the daily order for Enulose, it should have been apparent to the facility that the Dulcolax was also "sorely needed" by the resident. Id. We find that substantial evidence supports this conclusion.

We therefore affirm FFCL 7.

FFCL 8. Quality of Care (Tag F309). The facility failed to provide necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being.

A facility's obligations with respect to quality of care are set forth in 42 C.F.R. § 483.25, which provides, 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 ALJ Decision addresses Residents 159, 96, 106, and 36.

Resident 159

The ALJ described how Resident 159 was at risk for aspiration and Batavia twice failed to elevate the head of the bed to 90 degrees at meal time or to have staff assist in feeding. ALJ Decision at 19, 20. The record reflects an order which calls for "swallowing strategies: upright 90 degrees, chin tuck, small bites/sips." P. Ex. 13, at 7.

We find no merit to Batavia's argument that the ALJ wrongly concluded that Resident 159 was twice eating without staff assistance when the surveyor observed the resident in bed alone at meal time with a meal tray in front of him. RR at 15. We can think of little other inference that the ALJ should draw from those facts. In any event, Batavia pointed to no evidence to contradict the surveyor's observation, during two meals, that the resident's head was not elevated more than 40 degrees. Thus, the record as a whole supports the ALJ's conclusion that the facility failed to follow the swallowing strategies ordered, thereby putting the resident at risk for aspiration.

Resident 96

The ALJ described how Batavia provided Resident 96 with orange juice, which was at that time documented in the resident's medical chart as an allergen. ALJ Decision at 19, 20. Batavia argued that, contrary to the medical chart, Resident 96 was not actually allergic to orange juice. RR at 15, citing P. Ex. 7, at 10; Reply Br. at 12. A post-survey record, dated October 27, 2000, documents the resident's "intolerance" to oranges, while noting that the "allergy to OJ" was discontinued on October 17. P. Ex. 7, at 11; CMS Ex. 1, at 28 (October 16 observation). Batavia implied that it cannot be cited under this regulation because the factual premise (an allergy to orange juice) is inaccurate.

This argument misses the point: Batavia failed to provide services in accordance with its records and gave a documented allergen to a resident. Even if this resident's medical chart was wrong, there was a potential for more than minimal harm since Batavia might have ignored recorded contraindications for this and other residents, as well. ALJ Decision at 20.

In any event, even if the resident were not allergic to orange juice, the post-deficiency discontinuation of the resident's documented allergic condition also reflects that the resident was now considered "intolerant" to oranges. P. Ex. 7, at 11. We find that providing juice from a fruit to which the resident is documented as "intolerant" would still constitute a failure to provide care or services to attain or maintain the highest practicable physical, mental, and psychosocial well-being, consistent with a comprehensive assessment and POC.

Resident 106

The ALJ described how the surveyor observed Resident 106 not wearing prescribed anti-embolism stockings. ALJ Decision at 20. Batavia argued that the ALJ's finding should be reversed because the hose "need to be removed occasionally to be cleaned . . . ." Batavia also argued that Resident 106 "refused to wear the stockings and the order was discontinued." RR at 16.

The record reflects an order for "bilateral knee high anti embolism stockings may remove for hygiene then reapply," signed as reviewed by facility staff on September 25, 2000. P. Ex. 16, at 5. The surveyor observed the resident not wearing the hose on October 17, at 10:05 AM and 1:25 PM. CMS Ex. 1, at 28. Batavia did not dispute these observations.

There is no evidence to support that the resident was not wearing the hose for hygienic purposes at the time of the surveyor's observations. Instead, the unrebutted evidence is that the surveyor observed the resident without the stockings, first, while receiving range of motion exercises and, next, while receiving incontinence care. Tr. at 213; CMS Ex. 1, at 28. Batavia pointed to nothing which would indicate that the hose were removed for hygienic purposes or that the hose had been reapplied between the two observations. Since the resident was seen without the hose twice within approximately three hours, the ALJ drew the reasonable inference that they were, at minimum, not reapplied after the first instance, contrary to the physician's order.

The ALJ also recounted the testimony of consultant Kimberly Parks, who stated that the resident refused to wear the stockings and that they were thus discontinued by the physician. ALJ Decision at 20, citing Tr. at 458, 473-74; RR at 16. On cross-examination, Ms. Parks testified that the hose were discontinued "at the beginning of November," after the surveyor's observations. Tr. at 475. Ms. Parks further testified that "we typically wait for the resident to set up a pattern of non-compliance," presumably before seeking a physician order for discontinuance. Id.

We find, however, that Ms. Parks' testimony is inconsistent with the evidence of record and otherwise unpersuasive. The record contains an order discontinuing the hose not at the beginning of November, but on October 19, two days after the surveyor's observation. P. Ex. 16, at 5, 9. Nurse notes submitted into evidence cover the period July 29 through October 22, 2000, but contain no documented entry of the resident refusing to wear the hose. Id. at 10-36. The same notes, however, reflect multiple documented instances of the resident refusing medication, care, and meals and also reflect multiple changes in physician orders. See, e.g., id. at 17-18, 23, 25-28. Indeed, the only entry in the notes pertaining to the hose is in an undated "addendum" to an entry dated October 18, the day after the surveyor's observation, stating that the "Ted hose off r/t heel wound." Id. at 34.

Ms. Parks was the regional director of a nurse consulting firm that assisted Batavia in preparing for and responding to state surveys. Tr. at 436-47. The record does not reflect that she had first hand knowledge of or participated in the care provided to this resident. In contrast to her testimony, the record does not reflect a pattern of resident noncompliance with respect to the prescribed hose, although it amply reflects that Batavia knew how to document noncompliant behavior. Ms. Parks' testimony was inaccurate by at least two weeks on when the hose were discontinued.

In short, other than the testimony of Ms. Parks, there is nothing in the record to reflect that the resident refused to wear the prescribed hose. The record instead reflects that Batavia knew how to document resident noncompliance with treatment, as shown by the entries cited above. The only entry concerning the hose before the October 19 discontinuance reflects that they were taken off that day because of a heel wound, not noncompliance. We thus find that Ms. Parks' testimony is insufficient to overturn the ALJ.

We therefore find that substantial evidence supports that Batavia failed to comply with this participation requirement for Resident 106.

Resident 36

The ALJ described how staff failed to implement interventions when Resident 36 exhibited belligerent and inappropriate behavior toward staff during personal care. ALJ Decision at 21. Batavia's central argument is that Resident 36 "ha[d] a history of racism" and exhibited belligerent behavior when in the presence of African-Americans. Batavia contended that the resident "became verbally abusive and belligerent" during the surveyors' observations of personal care because an African-American federal surveyor "insisted on observing" care provided. Batavia maintained it did not have African-American staff provide care to this resident. RR at 16.

The ALJ concluded "that the resident's outburst was [not] provoked by federal surveyors." ALJ Decision at 21. In doing so, he credited the testimony of Surveyor Guttery that African-American federal surveyors sat behind a privacy curtain and outside the view of the resident during care. Ms. Guttery also testified that Batavia staff who provided care were African-American. The ALJ noted that Ms. Guttery's testimony was based on personal observation, while conflicting testimony from Batavia social worker Amy Boehm was not. Id. We see no basis for disturbing this credibility assessment. Meadow Wood at 8 (Board deference to ALJ credibility assessments).

We have also considered the remainder of Batavia's contentions and find them adequately covered in the ALJ Decision or otherwise insufficient to warrant reversal.

Accordingly, we affirm FFCL 8.

FFCL 9. Quality of Care (Tag F311). The facility failed to ensure that its residents' abilities in activities of daily living do not diminish unless circumstances of the individual's clinical condition demonstrate that diminution was unavoidable.

A facility's obligations with respect to a resident's activities of daily living are set forth, in relevant part, at 42 C.F.R. § 483.25(a)(1), which provides as follows:

Based on the comprehensive assessment of a resident, the facility must ensure that- (1) A resident's abilities in activities of daily living do not diminish unless circumstances of the individual's clinical condition demonstrate that diminution was unavoidable. This includes the resident's ability to - (i) Bathe, dress, and groom; (ii) Transfer and ambulate; (iii) Toilet; (iv) Eat; and (v) Use speech, language, or other functional communication systems.

The ALJ Decision addresses Residents 177 and 36.

Resident 177

The ALJ described how Resident 177 had declined in the activities of daily living (ADLs), including transfer, ambulation, and personal hygiene. According to the ALJ, the resident had been independently ambulatory earlier in the year. At the time of the survey, the resident had a restorative care plan which included a goal of ambulating 100 feet with assistance. Although restorative staff documented the resident ambulating 8-10 feet in August, the surveyor did not witness the resident being ambulated by restorative staff during the October survey. The ALJ also discussed how the resident's care plan called for ambulation to the bathroom with staff assistance, yet the resident was unable to do so safely. The ALJ further noted a decline in the resident's ability to participate in personal care, dressing, and transfers. ALJ Decision at 22-24.

On appeal, Batavia repeated arguments made to and considered by the ALJ. Batavia maintained that the resident was on a restorative program and was ambulated three to five times a week, including during the survey. Batavia also maintained that the resident was noncooperative. RR at 17.

Batavia did not challenge the ALJ's finding that the resident was independently ambulatory earlier in the year. Batavia also did not contest the ALJ's finding that it failed to put into effect planned interventions to maintain or improve the resident's skills for dressing, transferring, or conducting personal hygiene. Batavia also did not dispute the ALJ's conclusion that this failure contributed to further decline in the resident's ability to participate in ADLs. ALJ Decision at 24. This undisputed finding and conclusion alone are sufficient to uphold the deficiency cited. (46)

Moreover, Batavia's assertion that restorative staff ambulated the resident consistent with the POC is unsupported. (47) According to Batavia, its witness testified that "the restorative aide initialed off on the clinical restorative records for each of those days." RR at 17, citing Tr. at 428 (testimony of Tamela Lewis, RN). Batavia mischaracterized Ms. Lewis's cited testimony, which actually states:

Q: Ma'am, did Resident 177's clinical record reflect that the restorative aides provided ambulation?

A: Yes.

MR. WEBSTER: That's all I have.

Tr. at 428.

Ms. Lewis did not testify to the time frame of the purported record entries or how staff documented restorative ambulation. Instead, she also testified that she had not provided any ambulatory services to Resident 177 and had not observed staff members doing so during the survey. Id. Given Ms. Lewis's lack of first-hand knowledge, the general nature of her testimony, and Batavia's failure to produce the most probative evidence - the initialed records - the ALJ reasonably concluded that Batavia had failed to comply with the participation requirement.

Resident 36

The ALJ described how the care plan for this resident called for staff to encourage the resident "to participate as able each day" in assisting with ADLs. The ALJ concluded that Batavia provided no evidence that its staff encouraged such assistance or that the staff provided services to maintain or improve the resident's abilities with ADLs. The ALJ rejected Batavia's general argument that the resident was "often noncompliant." ALJ Decision at 24, citing P. Br. at 24; P. Ex. 17.

Batavia argued on appeal that Resident 36 "was extremely agitated" due to the presence of an African-American federal surveyor. Batavia further argued that staff failed to encourage the resident to participate in the care provided, since doing so was futile in his then agitated state. RR at 18.

As discussed with respect to FFCL 8, we affirm the ALJ's finding that the presence of an African-American federal surveyor did not trigger the resident's agitated state. See supra p. 43. Substantial evidence supports the ALJ's finding in FFCL 8 that the federal surveyor sat behind a privacy curtain outside the view of Resident 36 and that facility staff who provided care were African-American. Id.

In addition, we reject Batavia's argument that resident agitation excused Batavia's failure to meet its obligation to encourage the resident to assist with care. As the ALJ noted, the resident's care plan called for "strict limits on the resident's inappropriate behavior by diverting his attention to something else or providing time out." ALJ Decision at 21. Batavia pointed to no evidence that it attempted care planned interventions to calm the resident. Batavia's failure to implement one care plan intervention (redirection or time out as anxiety-reducing strategy) cannot be used to excuse its failure to implement another (encouragement to participate in care). At bottom, Batavia's argument here is that the resident was noncompliant with care planned interventions. The ALJ considered and reasonably rejected this argument. ALJ Decision at 24, 21.

We therefore affirm FFCL 9.

FFCL 10. Quality of Care (Tag F312). The facility failed to provide proper care and services to residents unable to perform activities of daily living.

A facility's obligations with respect to quality of care (activities of daily living) are set forth, in relevant part, at 42 C.F.R. § 483.25(a)(3), which provides as follows:

Based on the comprehensive assessment of a resident, the facility must ensure that . . . [a] resident who is unable to carry out activities of daily living receives the necessary services to maintain good nutrition, grooming, and personal and oral hygiene.

The ALJ Decision addresses Residents 168, 155, 36, and 8.

Resident 168

The ALJ discussed how Resident 168 had a history of right and left hip fractures. ALJ Decision at 24; P. Ex. 26, at 1. The ALJ then noted surveyor observations that Resident 168 cried out in pain after a nurse's aide pushed and turned her onto her right hip during incontinence care. ALJ Decision at 25. The ALJ further recounted how the staff member used a soiled washcloth during perineal care. Id. The ALJ concluded that Batavia did not dispute this deficiency. Id. at 26.

Batavia argued on appeal that the resident's right hip fracture occurred long ago and had fully healed by the time of the survey. RR at 18. Batavia further argued that CMS conceded that the aide used "a number of clean washcloths" during incontinence care. Batavia finally asserted "that the resident was a hospice patient." Id. at 19.

We find Batavia's arguments baseless. With respect to the resident's expressions of pain, Batavia did not dispute that the resident cried out during the care provided, but argued only that the resident's right hip fracture was not the cause. However, a physician's order reviewed by a facility nurse on September 28, 2000 (less than one month before the survey), diagnoses the resident with a right hip fracture and calls for physician followup. P. Ex. 26, at 4. In any event, Batavia did not dispute that the care provided resulted in the resident's expressions of pain.

With respect to the washcloths used doing incontinence care, Batavia did not dispute the testimony of Surveyor Truett that the nurse aide kept "supposedly clean washcloths" in the same water into which he dropped washcloths soiled with feces. Tr. at 127-28. The ALJ could reasonably conclude that this process, on its face, constituted improper incontinence care.

We also reject Batavia's implied argument, made more than once in this case, that otherwise deficient care is permissible when provided to an individual who has elected hospice services. RR at 19, citing Tr. at 128, 183 ("CMS found . . . that the resident was a hospice patient.")

First, the fact that a resident in a nursing home might elect hospice services does not relieve the facility from compliance with federal participation requirements. (48) The hospice and the SNF must prepare a coordinated POC which "must identify the care and services which the [SNF] and hospice will provide . . . ." SOM, Ch. 2, § 2082.A; see also SOM, Ch. 10, Appendix P-53. Both the hospice and the SNF must keep "[e]vidence of this coordinated plan of care . . . in [their] clinical records . . . ." SOM, Ch. 2, § 2082.A. "Even though the [SNF] is the hospice patient's residence for purposes of the hospice benefit, the [SNF] must still comply with all [SNF] Requirements for participation in Medicare or Medicaid." Id. (emphasis supplied). To the extent that Batavia argued that ODH should not have surveyed a hospice patient in a survey of SNF residents (which is entirely unclear from Batavia's Request for Review), this argument is based on an error of law.

Second, the resident's prognosis is irrelevant in assessing whether the quality of services provided meets federal participation requirements. As we have observed, resident neglect (49) is not excused by the fact that a resident is terminally ill.

Were it otherwise, facilities could with impunity neglect or mistreat the terminally ill in a manner that could hasten their deaths or increase their suffering beyond the unavoidable, and then argue that the residents were sure to die regardless so that any harm that might or did transpire could not be proven to derive from the neglect as opposed to the course of illness.

Emerald Oaks at 29 (upholding deficiencies concerning a terminally ill resident).

Finally, Batavia points to no evidence that this resident was, in fact, receiving hospice services at the time of the survey. The testimony to which Batavia cites concerns Resident 182, not Resident 168. RR at 18-19, citing Tr. 128, 183; see Tr. at 182-83 (discussion of Resident 182 and fact that she was not on hospice services at the time of the survey).

Resident 155

The ALJ found that Batavia did not provide incontinence care every two hours as called for by the POC. ALJ Decision at 25; see Tr. at 112, CMS Ex. 21, at 16. Batavia did not dispute this finding. Batavia also did not dispute the finding that the facility provided incontinence care, first, at 7:00 AM and, next, at 10:10 AM, a span of three hours and ten minutes. Batavia's assertions that the resident ate breakfast at 8:00 AM and that CMS did not prove that the resident sat in a soiled diaper for any period of time are irrelevant. Batavia failed to assess the resident for incontinence within two hours from its prior check, as called for by the POC.

Resident 36

The ALJ found that facility staff did not properly cleanse the resident's foreskin area, dry the perineal area and buttocks, or offer to change the resident's wet pants during incontinence care. ALJ Decision at 25. On appeal, Batavia cross-referenced arguments "set forth elsewhere in this brief." RR at 19.

Batavia did present various arguments regarding Resident 36 in relation to FFCLs 8 and 9. See discussion supra pp. 43-44, 46-47. Assuming that Batavia intended to cross-reference FFCLs 8 and 9, we reject what seems to be the facility's continued reliance on this resident's purported belligerence as a basis for reversing the ALJ's findings. As the ALJ noted, there is no evidence that the resident's hostility "had anything to do with the facility's failure to provide proper hygiene . . . ." ALJ Decision at 26.

We also reject Batavia's argument by unexplained cross-reference for reasons that we explain in our discussion of FFCLs 13, 15, and 19. See infra pp. 56-58, 63-64, 68-69.

Resident 8

The ALJ found that this blind resident spilled food on himself during self-feeding on two separate days. The ALJ further found that staff failed to clean the resident upon entering the room. The ALJ did not give any weight to the testimony of consultant Kimberly Parks that the resident would receive a scheduled bath later that day. The ALJ noted that there was no evidence as to when or whether the resident was bathed on these days. The ALJ further noted that Ms. Parks "failed to explain why staff entering the resident's room made no effort to clean him up during or after he had eaten breakfast." ALJ Decision at 25-26.

Batavia argued on appeal that the resident's spillage resulted from "his vision problem." Batavia then reiterated Ms. Parks' position, that a subsequent bath insured that "he did not remain with food on his clothing." RR at 19; Reply Br. at 15. We find these and other arguments by Batavia are neither new (having been adequately considered by the ALJ) nor consequential. RR at 19; Reply Br. at 15.

We therefore affirm FFCL 10.

FFCL 11. Pressure Sores (Tag F314). R169 was admitted to Petitioner's facility without pressure sores and was not provided with pressure relief devices or other appropriate care to prevent skin breakdowns.

A facility's obligations with respect to quality of care (pressure sores) are set forth in 42 C.F.R. § 483.25(c), which provides as follows:

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 pressures sores receives necessary treatment and services to promote healing, prevent infection and prevent new sores from developing.

The ALJ Decision addresses Resident 169.

Resident 169

The ALJ found that Resident 169 had developed avoidable pressures sores while at Batavia, that Batavia had failed to provide care necessary to prevent new pressure sores, and that Batavia did not provide "appropriate treatment and services to promote healing of the facility acquired pressure sores." ALJ Decision at 28. In reaching these findings, the ALJ noted the "precise description by [Surveyor] Truett of the pressures sores acquired" and the "following undisputed evidence of record:"

1. Ms. Truett observed that Resident 169 was not provided incontinence care every two hours, as required by the POC. When care was provided after almost three and a half hours, the resident had a "urine and feces soiled incontinent brief."

2. Ms. Truett observed that Resident 169 was not repositioned every two hours, as required by the POC.

3. Ms. Truett observed that the resident was seated on a canvas pad (50) in a "Geri-chair," without any pressure relieving device under the pad.

4. Ms. Truett observed incontinence care that worsened the pressure sores, when she saw a nurse aide wiping fecal matter from the resident's buttocks across open sores.

5. Batavia failed to follow the physician's order requiring a dressing over one wound site.

6. Batavia failed to provide frequent incontinence checks, despite the resident's condition of neurogenic bladder. (51)

7. Batavia's argument that the wounds at issue were self-inflicted scratches ignored that the resident suffered post-stroke left hemiparesis and had limited range of motion, thus making it "unlikely" that she could have scratched her own backside.

8. Batavia presented no evidence of facility efforts to prevent or promote the healing of pressure sores.

ALJ Decision at 28-29. The ALJ dismissed as insufficient Batavia's "[m]ere general denial of the existence of pressure sores and other inconsequential arguments. . . ." Id. at 29.

Batavia's central argument on appeal is that the "spots in question were not pressure sores," but either self-inflicted scratches or generalized redness of the skin. RR at 20. (52) We find that the ALJ amply considered this argument when weighing the testimony of Batavia witness Carol Watson and Surveyor Truett. ALJ Decision at 27-28. (53) As noted previously, absent a compelling reason, we defer to credibility assessments made by an ALJ, and we do so again in this instance. Meadow Wood at 8. However, we make several additional observations based on our review of the entire record.

Batavia contended, as it did before the ALJ, that what Ms. Truett described as a pressure sore on the coccyx was "an abrasion caused by scratching." RR at 20. The record contains a Skin Condition Progress Report which reflects an entry by Ms. Watson that the facility's wound care specialist viewed areas "on [the resident's] buttocks & on [right upper] thigh." P. Ex. 27, at 25. (54) Ms. Watson then wrote "that resident is scratching leg." Id. Ms. Watson did not document similar scratching by the resident to her buttocks or coccyx. This omission undermines Ms. Watson's testimony that the wound area involving the buttocks was caused by the resident's self-inflicted scratching. Tr. at 433.

Batavia also asserted that the wound specialist concluded that scratching caused the problem areas. However, the documentary evidence that Batavia cited are records involving the right thigh and chest, not the buttocks. RR at 20, citing P. Ex. 27, at 25-30. Further, a single entry on a "Skin Condition Progress Report," dated what appears to be October 20 and signed by Ms. Watson, mentions briefly that a wound specialist "look[ed] at areas on buttocks." P. Ex. 27, at 25. The record does not reflect, however, that the buttocks area wounds were caused by scratching or that the wound specialist so concluded.

Batavia also argued that the ALJ erred by stating that the facility permitted Resident 169 "to remain for prolonged periods with urine and feces soiled incontinent brief." RR at 20, citing ALJ Decision at 28. Batavia did not contest that the resident was not provided with incontinence care or otherwise approached by staff for over three hours, as observed by Surveyor Truett. However, Batavia maintained that "there is no evidence that he sat in a soiled brief for that period of time. In fact, it is likely that he could have just soiled them." Id. This argument misses the point.

Batavia initiated interventions for "skin injury" related to this resident's decreased mobility on October 9, 2000. P. Ex. 27, at 2. Those interventions included the use of chair pads; incontinence care "per house policy;" turning every two hours and prn; and repositioning in the chair every 1 hour and prn. Id. Batavia submitted no evidence concerning the content of its house incontinence policy and did not contest the surveyor's testimony that Batavia was required to provide incontinence care every two hours per the POC. Batavia also did not dispute that the resident wore a urine and feces soiled brief after almost three and a half hours of sitting up without staff checks.

In short, the duration of time during which the resident may have sat in a soiled brief is not relevant. Batavia conceded that it failed to provide incontinence services called for by the POC. We affirm the ALJ's finding that this failure promoted worsening of the pressure sores.

We therefore affirm FFCL 11.

FFCL 12. Quality of Care (Tag F315). CMS established that Petitioner was not in compliance with the quality of care requirements at Tag F315.

A facility's obligations with respect to quality of care (urinary incontinence) are set forth, in relevant part, at 42 C.F.R. § 483.25(d)(1), which provides as follows:

Based on the resident's comprehensive assessment, the facility must ensure that - (1) A resident who enters the facility without an indwelling catheter is not catheterized unless the resident's clinical condition demonstrates that catheterization was necessary . . . .

The ALJ Decision addresses Residents 106 and 96.

Resident 106

The ALJ concluded that Batavia successfully rebutted CMS's prima facie case with respect to Resident 106. ALJ Decision at 31. Batavia curiously appealed this conclusion in its favor and argued that the catheterization of Resident 106 was appropriate, given the resident's recent hip surgery and pressure sore on the heel. RR at 21-22; Reply Br. at 16. As the ALJ made a finding on precisely this point, and in Batavia's favor, we conclude that Batavia's appeal is a result of an incomplete reading of the ALJ Decision. CMS did not appeal the ALJ's conclusion, which we therefore leave undisturbed.

Resident 96

The ALJ discussed this resident's readmission to the facility on July 18, 2000, following a hospitalization for pneumonia. The resident had a catheter in place when readmitted. Surveyor Fran Tucker testified that catheterization increases the risk for a urinary tract infection (UTI) and that the resident had two UTIs before the catheter was removed in October. Ms. Tucker also testified that when questioned about the necessity of the catheter, facility representatives "said that there was no supporting diagnosis [and] removed the catheter." According to Ms. Tucker, once contacted by the facility, the attending physician agreed that the resident did not need the catheter. Ms. Tucker also testified that the resident had pulled "at the catheter and wanted to know why it was there, and she was upset that no one had told her that she had a urinary catheter in place." ALJ Decision at 29-30, citing Tr. at 259-262.

Batavia argued on appeal that the catheter was in place per a physician's order and that the resident's status as a hospice patient warranted its continued use for comfort purposes. RR at 21; citing P. Ex. 7.

We agree with the following ALJ observation:

The resident's reaction to the catheter and the recurrent urinary tract infections should have prompted the facility to consult her physician regarding its need much sooner. In fact, in the absence of a diagnosis justifying the need for the urinary catheter, Petitioner should have contacted the treating physician immediately upon the resident's return to the facility.

ALJ Decision at 30. We further agree with the ALJ that the provision of hospice services is insufficient, standing alone, to satisfy the regulatory proscription against unnecessary catheterization. Id.

We therefore affirm FFCL 12.

FFCL 13. Quality of Care (Tag F316). CMS established that Petitioner was not in compliance with the quality of care requirements at Tag 316.

A facility's obligations with respect to quality of care (urinary incontinence) are set forth, in relevant part, at 42 C.F.R. § 483.25(d)(2), which provides as follows:

Based on the resident's comprehensive assessment, the facility must ensure that - . . . (2) A resident who is incontinent of bladder receives appropriate treatment and services to prevent urinary tract infections and to restore as much normal bladder function as possible."

The ALJ Decision addresses Residents 177, 38, and 106.

Residents 177, 38, and 106

The ALJ found that Residents 177, 38, and 106 received incontinence cleansing that was inadequate and failed "to prevent the potential for urinary tract infections." ALJ Decision at 31, 32. Care plan requirements called for incontinence care for Residents 177 and 38 every two hours. According to the ALJ, the state surveyor observed no such care over a three-hour period. When a nurse aide then removed urine and feces soiled incontinence briefs, the aide "did not provide cleansing of the perineal area before applying a clean incontinent brief." Id. at 31. The ALJ also noted that after an episode of stool incontinence for Resident 106, the nurse used a heavily soiled washcloth to wipe stool from the anal area forward to the perineal area, where the resident had an opening for a urinary catheter. The ALJ concluded as to all three residents that "except for inconsequential argument," Batavia did not challenge the substance of the deficiency and failed to rebut CMS's prima facie cases. Id. at 32.

Batavia argued on appeal that this deficiency is related to other findings involving Residents 177 and 106, and stated that it "reiterates its responses made elsewhere in this brief and incorporates them in [sic] by reference." RR at 22. As to Resident 38, Batavia took issue with whether the resident sat in a soaked incontinence brief during the entire period of observation. Id.

We find that Batavia's arguments are inadequate to overturn the ALJ's findings. As a threshold matter, our Guidelines require that Batavia provide the Board with legal and factual bases for challenging each deficiency cited. Guidelines, ¶ 2(c). (55) Our Guidelines also make clear the following:

The Board 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. The Board will not consider issues not raised in the request for review, nor issues which could have been presented to the ALJ but were not.

Id. at ¶ 4(c). The Board may decline to consider an issue that is "unaccompanied by argument, record citations, or statements that articulate the factual or legal basis for the party's objection to the ALJ's findings." Wisteria Care Center, DAB No. 1892, at 10 (2003), citing Guidelines. We "may summarily affirm a factual or legal finding if a party's presentation of an issue regarding that finding is such that the Board cannot discern the legal or factual basis for the party's disagreement with it." Id. We find that in this instance, Batavia's incorporation of other portions of its brief, without citation by page or section number and without any indication how those arguments would apply in the instant analysis, is an insufficient means of raising an issue for review and an inadequate basis upon which to adjudicate the appeal. (56)

In any event, we agree with the ALJ that Batavia did not dispute the factual underpinnings of the deficiency. Our review of the record as a whole supports that Batavia staff failed to check for episodes of incontinence, as required by resident care plans for Residents 177 and 38. We further find that substantial evidence supports the finding that Batavia staff failed to properly cleanse Resident 106's genital/perineal area of urine and fecal matter during incontinence care.

We therefore affirm FFCL 13.

FFCL 14. Quality of Care (Tag F324). CMS established that Petitioner was not in compliance with the quality of care requirements at Tag F324 because it failed to provide supervision and assistive devices to prevent accidents.

A facility's obligations with respect to quality of care (accidents) are set forth at 42 C.F.R. § 483.25(h)(2), which provides as follows: "The facility must ensure that . . .(2) Each resident receives adequate supervision and assistance devices to prevent accidents." The ALJ Decision addresses Residents 177, 159, and 32. (57)

Resident 177

The ALJ described a series of falls and related inadequate documentation. (58) On July 3, 2000, the resident's treating physician was notified of two falls in one 24-hour period from July 2 to July 3, although the resident's record documented only the first. (59) The facility then implemented a lap cushion restraint. On August 4, Resident 177 was found on the floor. Surveyor Truett testified that her record review indicated that nursing staff documented no injuries noted as of 4:37 AM. Tr. at 87-88; CMS Ex. 21, at 19. A 2:30 PM nursing entry the same day, however, reflected that the resident "complained of lumbar pain as a result of the fall." Tr. at 93; CMS Ex. 21, at 19. The surveyor's review also reflected bruising to the resident's left shoulder and reddened areas on the buttocks and scratching. Tr. at 94; CMS Ex. 21, at 19. The resident was also documented later that day as having been found on her knees by her bed and later on the floor by the bathroom door. The resident's care plan called for a bed pad alarm, but the ALJ found "no evidence, however, that this intervention was in place at the time of the falls." ALJ Decision at 32-33.

The resident also slid out of her wheelchair, and her physician then ordered a reclining chair with a meal tray during meals in response. The resident's care plan also called for a call light within reach at all times, but the surveyor observed the resident numerous times in her bed or chair without the call light in reach. The ALJ also noted how the resident was left unattended on her toilet on October 17. Id. at 34; CMS Ex. 1, at 47, 48.

Batavia argued on appeal that the ALJ erred in finding that the August 4 fall caused the resident actual harm. Batavia also argued that adequate interventions were put into effect following the July 3 fall, including an assessment, physical therapy evaluation, and a check for a UTI as a condition that could affect her gait. Batavia further argued that leaving the resident unattended on the toilet provided the resident with privacy and that a call light was within reach from the toilet. RR at 22-23.

We note first that Batavia's assertion that the ALJ erred by finding "actual harm" in relation to the August 4 fall raises an issue outside the scope of our review. RR at 22, citing Tr. at 87; see ALJ Decision at 35. Deficiencies are categorized according to their "seriousness" (or "level of noncompliance"). Wisteria at 2. "Seriousness" is a function of the scope and severity of the deficiency, as determined by the survey agency and CMS. Id., citing 42 C.F.R. § 488.404, SOM Ch. 10, App. P, § V.

"Scope" refers to whether the cited deficiency is isolated, constitutes a "pattern," or is widespread. Id., citing 42 C.F.R. § 488.404(b)(2); see also SOM Ch. 7, § 7400E.1. "Severity" refers to the degree of harm or potential harm to the resident as a result of the deficiency. Id., citing 42 C.F.R. § 488.404(b)(1); SOM Ch. 7, § 7400E.1. The "severity" of a deficiency falls into one of four categories: no actual harm with potential for more than minimal harm; no actual harm with potential for more than minimal harm that is not immediate jeopardy; actual harm that is not immediate jeopardy; and immediate jeopardy to resident health or safety. 42 C.F.R. § 488.404(b)(1).

As we have previously concluded, a provider does not have the right to appeal a CMS determination of the "level of noncompliance [seriousness] unless 'a successful challenge on this issue would affect the range of civil money penalty amounts that CMS could collect.'" Meadow Wood at 7, citing 42 C.F.R. § 498.3(b)(14); (60) see also 42 C.F.R. § 498.3(d)(10)(ii). (61) We have interpreted these regulations to mean that a provider has no appeal rights on scope and severity "except in the situation where that finding was the basis for an immediate jeopardy determination." Meadow Wood at 7 (citations omitted). In sum, the severity of injuries associated with a fall is generally not a matter within the scope of our review, unless immediate jeopardy is an issue (and it is not in this case). (62)

The remainder of Batavia's arguments also fail. Contrary to Batavia's assertion, the ALJ did not find that Batavia failed to document and put into place interventions following the July 3, 2000, fall. RR at 22. Instead, the ALJ considered the interventions that Batavia identified at the hearing: a post-fall assessment, physical therapy evaluation, and examination for urinary tract infection, as well as medication review and assistive devices. ALJ Decision at 34. The ALJ found, however, that Batavia failed to document falls and also failed to "monitor the interventions implemented," which resulted in the August 4 fall. Id. at 35. Substantial evidence supports this finding.

We also reject Batavia's implied argument that leaving this resident unattended on a toilet struck a proper balance with the resident's right to privacy versus the facility's obligation to prevent accidents. RR at 23. As the ALJ noted, Batavia witness Rebecca Vincent testified that the resident had lost her ability to sit upright. ALJ Decision at 34, citing Tr. at 407-08. Ms. Vincent also testified that the facility provided this resident with a "foam-covered vinyl pad that . . . prevents residents from falling when they lean forward." ALJ Decision at 34. Substantial evidence thus shows that the facility recognized the resident's risk of falls and put interventions into effect to minimize that risk. We therefore agree with the ALJ that subsequently leaving this resident "unattended twice while sitting alone on the toilet," at minimum, created an unacceptable risk of accidents. ALJ Decision at 35; Rosewood Care Center of Edwardsville, DAB No. 1898, at 10 (2003)(risk of fall from toilet due to inadequate supervision).

Resident 159

On August 4, 2000, this resident was assessed as at risk for falls, and the facility put several interventions into the POC, including a restraint-free alarm "on at all times" (63) and a bedside commode. P. Ex. 13, at 5. While the POC indicates that the alarm was discontinued on September 13, the ALJ noted the facility's argument that this was an erroneous entry. By contrast, the ALJ also noted that facility witness Rebecca Vincent testified that the alarm had in fact been discontinued at the request of the resident and his wife. ALJ Decision at 35-36; Tr. at 409-10.

Facility records indicated that on September 20, the resident was "found lying on floor beside bed - stated attempting to go to [bathroom]." CMS Ex. 21, at 43; Tr. at 410. (64) The ALJ then discussed how the resident was found on the floor twice on October 8, with profuse bleeding from his right elbow and two fractured left ribs. The alarm either did not sound or had been removed by the resident. The ALJ agreed with the opinion of Surveyor Truett, who testified that "if the [alarm] was not appropriate," several alternative devices should have been considered. The ALJ concluded that Batavia failed "to provide supervision and assistive devices" for fall prevention and failed to rebut CMS's prima facie case. ALJ Decision at 36-37.

Batavia argued that the ALJ erred by applying the burden of proof standard established in Hillman. See discussion supra pp. 8-22. Batavia then, essentially, listed interventions reflected on a "Plan of Care For Falls" dated August 4, 2000, before the September 20 and October 8 falls. Batavia also argued that the resident shared a room with his wife and that their desire for privacy and independence impeded Batavia's interventions. RR at 23-24, citing P. Ex. 13, at 5, 11.

At bottom, Batavia submitted no new material argument on appeal. We reject Batavia's Hillman challenge, as discussed previously in this decision. See discussion supra pp. 8-22. We find the remaining arguments to be duplicative of those made before the ALJ, which are adequately addressed in the ALJ Decision at pages 36-37 or are otherwise insufficient to overturn the ALJ.

We therefore affirm FFCL 14.

FFCL 15. Quality of Care (Tag F325). CMS established that Petitioner was not in compliance with quality of care requirements at Tag 325 because it failed to maintain acceptable parameters of nutritional status regarding R182.

A facility's obligations with respect to quality of care (nutrition) are set forth at 42 C.F.R. § 483.25(i)(1), which provides as follows:

Based on a resident's comprehensive assessment, the facility must ensure that a resident - (1) Maintains acceptable parameters of nutritional status, such as body weight and protein levels, unless the resident's clinical condition demonstrates that this is not possible . . . .

The ALJ Decision addresses Resident 182.

Resident 182

The ALJ discussed a 12.5% weight loss for this resident from July 5 through October 12, 2000. On October 3, facility staff documented that tube feeding may have been the only option available for maintaining the resident's weight. P. Ex. 6, at 6. On October 5, the physician ordered a daily calorie count for three days, from October 6-8. Id. at 12. The facility failed to document the calorie count for breakfast and lunch on both October 7 and 8. Id. at 5. (65) The ALJ also noted that after October 10, the record reflects no further documentation regarding the resident's condition. The ALJ found that the facility "failed to ensure that the resident maintained acceptable parameters of nutritional status." ALJ Decision at 37-38; see also discussion supra pp. 35-36.

Batavia appealed this deficiency as follows: "See Batavia's response to FFCL 5 with respect to Resident 182." RR at 24. FFCL 5 concerned the facility social worker's failure to respond to the family's request for a conference to discuss nutritional and hospice options for this resident. The deficiency at issue here, by contrast, addresses the facility's failure to comply with a physician's order to document caloric intake over a three-day period and to otherwise document its interventions pertaining to this resident's declining nutritional intake. Batavia's argument by cross-reference provided no indication of the legal or factual grounds upon which it sought to overturn the latter finding.

Even if we were to conclude that Batavia's cross-reference to FFCL 5 satisfied its obligations to plead its case for FFCL 15 (and we do not), we find, based on our review of the entire record for both deficiencies, that the ALJ's conclusions with respect to each are supported by substantial evidence.

We therefore affirm FFCL 15.

FFCL 16. Quality of Care (Tag F329). CMS established that Petitioner was not in compliance with quality of care requirements at Tag 329 because it failed to ensure that each resident was free from unnecessary drugs.

A facility's obligations with respect to quality of care (unnecessary drugs) are set forth, in relevant part, at 42 C.F.R. § 483.25(l)(1), which provides as follows:

Each resident's drug regimen must be free from unnecessary drugs. An unnecessary drug is any drug when used: (i) In excessive dose (including duplicate drug therapy); or (ii) For excessive duration; or (iii) Without adequate monitoring; or (iv) Without adequate indications for its use; or (v) In the presence of adverse consequences which indicate the dose should be reduced or discontinued; or (vi) Any combinations of the reasons above.

The ALJ Decision addresses Resident 96.

Resident 96

The ALJ discussed how this resident had a prn order for the anti-anxiety prescription medication Xanax. The facility's pharmacy consultant noted that in seven out of eight instances, the resident's record lacked any documentation of the resident's behavior or any non-pharmaceutical interventions attempted before the Xanax was provided. CMS Ex. 22, at 19; Tr. at 308-09. (66) The record also made no note of the effectiveness of the Xanax or any adverse reactions. CMS Ex. 22, at 19. The ALJ concluded that the facility's failure to document the circumstances under which the Xanax was administered provided no communication to the "resident's treating professionals as to the effectiveness, adverse reactions, or need to adjust the medication." ALJ Decision at 39-40.

Batavia argued on appeal that the drug was administered for the resident's "chronic" shortness of breath pursuant to a physician's order and "care plan for anxiety." Batavia also argued that the resident's hospice status called only for comfort care and providing the prn anti-anxiety medicine fell within that ambit. RR at 25-26, citing P. Ex. 7, at 4; Reply Br. at 18.

Batavia's arguments lack merit. The pharmaceutical consultant indicated that Xanax was administered on August 19 at 8:30 PM, August 22 at 9:30 PM, August 28 at 6:00 PM, September 5 and 8 at 4:00 PM and 8:00 PM, and September 11 at 8:00 PM. CMS Ex. 22, at 19. The facility documented on August 28 that the resident was "tearful/crying periodically about children etc. Redirection unsuccessful med [with] Xanax." Id. Batavia provided no evidence to document the need on the other dates, nor any notes to show whether the drug worked or had any adverse effects, as explained by the pharmacist. The care plan may indicate the general reason for the prn order, but does not constitute documentation that the drug was needed at any particular time to address the resident's anxiety, nor does it address whether the drug was effective or had adverse consequences.

We also note that the only time that Batavia documented the drug's indication shows the request triggered by familial concerns, not shortness of breath. Further, the care plan for anxiety cited by Batavia appears to be dated July 17, 2001, nine months after the survey. See P. Ex. 7, at 4. It is thus irrelevant. We also find unwarranted Batavia's continued reliance upon a hospice designation as a basis for overturning deficiency citations. (67) In FFCL 12, Batavia argued that this resident was not unnecessarily catheterized, in relevant part, due to her hospice status. See discussion supra pp. 55-56. Here, Batavia argued that the hospice status of this resident with a do not resuscitate order meant that she was "receiving comfort care" and "was not going to be rehabilitated." RR at 24-25. Thus, Batavia implies that a hospice status renders moot the facility's obligation to comply with the regulatory standard. As discussed in relation to FFCL 10, a hospice election does not excuse a SNF from compliance with Medicare participation requirements. See discussion supra p. 48.

We therefore affirm FFCL 16.

FFCL 17. Quality of Care (Tag F330). CMS did not establish that Petitioner failed to comply with the quality of care requirements at Tag 330 by failing to ensure residents who had not used antipsychotic drugs were not given those drugs unless antipsychotic drug therapy was necessary to treat a specific condition as diagnosed and documented in the clinical record.

The ALJ found that CMS failed to establish a prima facie case under this participation requirement. ALJ Decision at 41. CMS did not appeal this finding, which we therefore leave undisturbed.

FFCL 18. Dietary Services (Tag F369). CMS established that Petitioner did not provide special eating equipment and utensils for residents who needed them.

A facility's obligations with respect to dietary services (assistive devices), are set forth, in relevant part, at 42 C.F.R. § 483.35(g), which provides as follows: "The facility must provide special eating equipment and utensils for residents who need them." The ALJ Decision addresses Resident 8.

Resident 8

The ALJ describes how the surveyor observed Resident 8, who was legally blind, feeding himself with a "plate guard" (68) improperly positioned on the back of the plate, not the front. The resident scooped food to the front of the plate and then spilled a significant amount as he brought the food to his mouth. The ALJ considered and rejected Batavia's arguments that the spillage was irrelevant, since the resident received nutritional supplements and double portions of food and, in any event, was overweight. The ALJ concluded that the facility's failure to ensure proper placement of the plate guard and the accompanying spillage compromised the resident's dignity and "is tantamount to not providing effective equipment to assist the resident in his ability to eat." ALJ Decision at 42-43.

Batavia did not challenge the ALJ's factual findings. Instead, it argued that allowing the blind resident to feed himself enhanced his independence and dignity, notwithstanding the spillage of food. RR at 25, citing Tr. at 463; Reply Br. at 18-19. (69) Batavia further argued that the resident "frequently moved the plate so he could have direct access to the food on the plate from which he was trying to eat," and that it was not the staff's intent to "insult the resident by baby sitting him while he ate," nor should he "loose [sic] his dignity by having someone feed him or stand over him while he eats." RR at 25; Reply Br. at 19.

Substantial compliance with this regulation would not require the outcome Batavia suggested, i.e., a wholesale diminution of resident dignity or independence as a result of Batavia feeding the resident, standing over him to assist with self-feeding, or guiding the spoon to his mouth. Instead, the uncontroverted evidence suggests a simpler approach: affix the plate guard to the front of the plate. Otherwise, it will not function as "special eating equipment," as intended. As the ALJ noted, "it is ironic that the facility would rather quarrel than simply place the plate [guard] in its proper position." ALJ Decision at 42.

Contrary to what Batavia suggested, the testimony it provided did not support a conclusion that the resident moved the plate, rather than the facility failed to position it correctly. See Tr. at 463. While Ms. Parks testified that she thought the issue was getting the food to the resident's mouth, rather than getting the food on the spoon, she also testified that the plate guard had been ordered to promote the resident's independence. Id. She did not deny that it was not being affixed correctly nor deny that improper use could be a cause of the spillage.

Substantial evidence supports that the facility did not provide special eating equipment to meet the resident's need.

We therefore affirm FFCL 18.

FFCL 19. Infection Control Practices Tag F441. CMS established that Petitioner did not follow the proper procedures to prevent cross-contamination infections.

A facility's obligations with respect to infection control (infection control program) are set forth, in relevant part, at 42 C.F.R. § 483.65(a), which provides as follows:

The facility must establish an infection control program under which it - (1) Investigates, controls, and prevents infections in the facility; (2) Decides what procedures, such as isolation, should be applied to an individual resident; and (3) Maintains a record of incidents and corrective actions related to infections.

The ALJ Decision addresses Residents 78, 38, and 106.

Residents 78, 38, and 106

The ALJ described how the facility failed to follow "appropriate infection control practices." The ALJ stated that the surveyors observed nurses' aides wearing stool soiled gloves and then handling or touching incontinence care materials and a resident's nightstand and bathroom door. The ALJ rejected Batavia's argument that the surveyors could not find a deficiency without knowing the rate of infections caused by facility practices (nosocomial rate), (70) because "where the facility is charged with a pattern of deficiencies with [no actual harm with] the potential for more than minimal harm, it is not relevant whether an actual spreading of infections occurred." The ALJ concluded that Batavia failed to rebut CMS's case that these practices, while not causing actual harm, "had the potential to cause more than minimal harm." ALJ Decision at 43.

Batavia presented the same argument on appeal that it presented before the ALJ, i.e., that there was no evidence that an infection occurred as a result of the deficient practices. RR at 26; Reply Br. at 19. We find that the ALJ amply considered this contention and that his conclusions are supported by substantial evidence and free of legal error. For a deficiency involving the potential for more than minimal harm that is not jeopardy, CMS is not required to put forth a prima facie case on actual harm.

Batavia also referred us to "other responses regarding Residents 78, 38, and 106, supra." RR at 26. Although it is wholly unclear from Batavia's pleading, we assume that these "other responses" are at FFCL 13. See supra pp. 56-58. In FFCL 13, Batavia cross-referenced arguments for Resident 106 "elsewhere in this brief" (thereby creating an endless loop of cross-reference between FFCLs 13 and 19); provided irrelevant argument for Resident 38; and made no argument whatever for Resident 78. RR at 22.

We therefore affirm FFCL 19.

FFCL 20. Infection Control Practices Tag F442. CMS established that Petitioner failed to ensure that isolation precautions were followed.

A facility's obligations with respect to infection control (preventing spread of infection) are set forth, in relevant part, at 42 C.F.R. § 483.65(b)(1), which provides as follows: "When the infection control program determines that a resident needs isolation to prevent the spread of infection, the facility must isolate the resident." The ALJ Decision addresses Resident 15.

Resident 15

The ALJ described how Resident 15 was readmitted to the facility on August 8, 2000, with "a respiratory infection which was resistant to antibiotics." ALJ Decision at 44. The ALJ noted that "[t]he facility's policy on prevention and control of these types of infections required that a mask be worn when working within three feet of the infected resident." CMS Ex. 46, at 2. On October 17, "the surveyor observed the nurse administer medications to R15 without wearing any type of mask." ALJ Decision at 44.

The ALJ rejected Batavia's argument that MRSA (71) precautions had been discontinued at the time of the deficiency, as the discontinuation order occurred the day after the deficiency was cited. Id., citing CMS Ex. 1, at 70; P. Ex. 10, at 6. The ALJ also found that the facility nurse showed lack of knowledge of the infection control policy, saying "you don't have to wear a mask if you don't want to." Id., citing Tr. at 346. The ALJ concluded that "this deficiency created the potential for more than minimal harm because the [staff member] could be exposed to the antibiotic-resistant bacteria and transmit it to other residents." Id.

Batavia argued on appeal that the resident was not in isolation for the antibiotic-resistant respiratory infection, but for a UTI. Batavia further argued that "[a]dministering medication would not cause the spread of the disease." Batavia finally argued that the ALJ's finding should be reversed, since "the reason for the [MRSA] order" no longer existed at the time the deficiency was cited. RR at 26, Reply Br. at 19.

The record contains Batavia's "Policy for Detection, Prevention, and Control of MRSA" (Policy), which sets forth standard precautions for the "Prevention and Control of Nosocomial Transmission of MRSA." CMS Ex. 46, at 1. Under the precaution for "masking," the Policy reads in its entirety as follows:

Masking - a mask and eye protection will be worn to protect mucous membranes of eyes, nose, and mouth during procedures and direct care activities that are likely to generate splashes and sprays of blood, body fluids, secretions, and excretions (i.e. suctioning). When caring for residents infected with Respiratory MRSA a mask will be worn when working within three feet of the resident. NOTE: AIRBORNE TRANSMISSION OF MRSA IS NOT CONSIDERED TO BE A SIGNIFICANT MODE OF TRANSMISSION, THEREFORE RESPIRATORY ISOLATION IS NOT NECESSARY OR APPROPRIATE.

CMS Ex. 46, at 1-2 (bold and capitals in original).

The surveyor testified that the risk of harm came from the possibility of the resident coughing "in close proximity to the nurse" who might then spread the germ to other residents. Tr. at 347. Batavia did not deny that the order discontinuing the MRSA precautions was not entered until October 18, but asserted instead that "the reason for the order had ceased prior to that time." Reply Br. at 19. Batavia did not dispute the findings that the nurse stood within three feet of this resident when "administer[ing] medications," but did not wear a mask, and that the staff showed a lack of knowledge of the infection control policy. ALJ Decision at 44; Tr. at 346. (While the Policy indicates that airborne transmission is not considered to be a significant mode of transmission, it is not consistent with Batavia's suggestion that MRSA is transmitted only by contact. Tr. at 464.) Instead, it offered the testimony of consultant Kimberly Parks who testified that the resident "was treated [with antibiotics] and treatments stopped and he was asymptomatic." Tr. at 464. However, she cited to nothing in the record which would support that the basis for the MRSA precautions no longer existed at the time the deficiency was cited. P. Ex. 10.

We therefore conclude that the ALJ's FFCL 20 is supported by substantial evidence on the record as a whole.

FFCL 21. Administration Tag F514. CMS established that Petitioner failed to maintain clinical records which were complete.

A facility's obligations with respect to administration (clinical records) are set forth, in relevant part, at 42 C.F.R. § 483.75(l)(1), which provides as follows:

The facility must maintain clinical records on each resident in accordance with accepted professional standards and practices that are - (i) Complete; (ii) Accurately documented; (iii) Readily accessible; and (iv) Systematically organized.

The ALJ Decision addresses Residents 182, 106, 155, and 177.

Residents 182, 106, 155, and 177

The ALJ found as follows for all residents under this deficiency:

I find that CMS has established a prima facie case under Tag 514. Petitioner has not disputed those deficiencies. Thus, I conclude that Petitioner's failure to maintain complete clinical records created a potential for more than minimal harm by not documenting information that would be useful in preventing risk of injuries to residents.

ALJ Decision at 45. The CMS 2567 generally alleges as follows:

Resident 182: The resident had significant weight loss and the facility failed to properly document a calorie count ordered by the physician and amount of meal intake. CMS Ex. 1, at 73-74.

Resident 155: The facility failed to document the origin of a skin tear documented on October 8, 2000. Id. at 74.

Resident 177: The resident "had a long and frequent history" of falls, physical restraints, and alarms. The facility failed to document the resident's falls and accidents in a comprehensive manner that would permit proper evaluation. Record entries on July 2 and August 4, 2000, reflect an incomplete recording of falls and associated prevention measures. Id. at 74-75.

Resident 106: The facility failed to adequately document the resident's fall on July 14, 2000, with subsequent broken hip. Id. at 75.

Batavia argued on appeal that the ALJ erred in concluding that it "failed to dispute this claim." Batavia contended that it raised and disputed the deficiency "as an appeal issue," citing its Request for Hearing and Report on Readiness prepared for the ALJ. Batavia further argued that it submitted both documentary and testimonial evidence concerning these residents. RR at 26-27.

We affirm the ALJ's findings of a deficiency under this tag. First, the issue before us is not whether Batavia appealed this deficiency to the ALJ, but whether Batavia rebutted the prima facie case established by CMS through its CMS 2567 and related evidence at the hearing. We affirm the ALJ's conclusion on the latter issue, based upon our review of the record as a whole.

Batavia then argued that it put forward evidence before the ALJ on these residents. RR at 27. Our review of the testimony actually cited by Batavia finds no instance in which the cited testimony addresses gaps in clinical record documentation. Further, we are unable to discern what rebuttal evidence Batavia wishes us to consider for this deficiency in facility records that it cited concerning Residents 182, 106, and 155, who were also subjects of citations in FFCLs 5 and 15; 8, 12, 13, and 19; and 10, respectively. Batavia cited no facility record for Resident 177.

We therefore affirm FFCL 21.

Amount of Civil Money Penalty

The ALJ affirmed CMS's finding that Batavia was not in substantial compliance with program requirements for isolated deficiencies which caused actual harm that was not immediate jeopardy. ALJ Decision at 1; CMS Ex. 5, at 1. The ALJ further concluded that CMS had established a "pattern of deficiencies that were not actual harm, but created the potential for more than minimal harm." ALJ Decision at 45. CMS imposed a CMP of $700 per day after providing notice to Batavia that it had considered the facility's history of noncompliance and financial condition, as well as factors set forth in 42 C.F.R. § 488.404. ALJ Decision at 45, citing CMS Ex. 5. (72)

With respect to the facility's history of noncompliance, the ALJ noted that the CMS OSCAR (Online Survey, Certification, and Reporting) Report reflected that "many" of the same deficiencies in the 2000 survey had been cited in the survey conducted in 1999. ALJ Decision at 45-46, citing CMS Ex. 16. (73) With respect to the facility's financial condition, he noted net income of $965,684, based on information from Batavia's Medicare cost report from June 1 through December 31, 2000. ALJ Decision at 46, citing CMS Ex. 15, at 1, 4. Concerning scope, severity, and culpability, the ALJ noted that CMS had failed to establish all deficiencies that CMS originally cited, which "impacts on CMS's perceived degree of culpability." Id. The ALJ therefore reduced the amount of the CMP from $700 to $600 per day. He concluded that CMS established that Batavia was not in substantial compliance with program requirements from "October 20, 2000 through December 13 [sic], 2000" at less than immediate jeopardy level and the $600 CMP was reasonable. ALJ Decision at 46.

Batavia argued on appeal that the $600 per day CMP is not "appropriate" as "CMS failed to prove that Batavia was not in substantial compliance" with program requirements, RR at 27, and that "the ALJ erred in finding that . . . the $600 per day CMP was reasonable." Reply Br. at 20. (74) As discussed above, the ALJ's determination that Batavia failed to substantially comply with participation requirements is supported by substantial evidence. We also find that the ALJ adequately considered the reasonableness of the CMP in relation to the regulatory criteria at 42 C.F.R. § 488.438(f). We thus affirm the ALJ's determination to impose a $600 per day CMP.

Conclusion

For the above reasons, we affirm the ALJ Decision in its entirety and sustain the CMP (totaling $32,400) 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. The correct end date of the period of noncompliance is December 12, 2000. CMS Ex. 8, at 2.

3. 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.

4. Surveyors gather information during compliance surveys through personal observation, interviews, and medical record review. SOM Appendix P, Task 5, at P-23 through 26. CMS advises surveyors to document information on forms that include "Surveyor Notes Worksheet" (HCFA 807) and "Resident Review Worksheet" (HCFA 805). Id. at P-13, 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-24.

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

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

7. "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).

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

9. The ALJ Decision provides an end date of December 13, 2000, for the period of noncompliance. ALJ Decision at 1, 46. CMS's January 9, 2001 letter imposing the CMP states the end date as December 12, which we use in this decision. CMS Ex. 8, at 2.

10. References to FFCLs herein shall be by their number under Section IV.A.

11. These consisted of seven deficiencies at Level D (Tags 157, 311, 315, 325, 329, 369, 442); ten at Level E (Tags 166, 246, 250, 253, 281, 309, 312, 316, 441, 514); and two at Level G (Tags 314 and 324).

12. These consisted of two deficiencies at Level D (Tags 164 and 330). CMS did not appeal these reversals.

13. These consisted of three deficiencies at Level B (Tags 174, 368, 518); one at Level C (Tag 466); two at Level D (Tags 242, 274); three at Level E (Tags 258, 332, 444); and one at Level F (Tag 371).

14. See "Request for Review and Brief in Support of Petitioner Batavia Nursing and Convalescent Inn of Decision CR-1027, Rendered by Administrative Law Judge Jose A. Anglada on April 18, 2003," for Docket No. C-01-317, Decision No. CR-1027, and dated June 19, 2003.

15. We note that Batavia has not argued that it lacked timely notice that it had the ultimate burden of persuasion in this proceeding. Cf. Batavia I at 8, n.9.

16. A "rule" is defined, in relevant part, as "the whole or a 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).

17. 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).

18. 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.

19. 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. 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.

20. 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.

21. 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.

22. 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).

23. Section 1866(a) of the Act 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.

24. Specifically, section 1819(h)(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.)

25. 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).

26. 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.

27. 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.

28. 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. Bell Aerospace, 416 U.S. at 289. The analytical approach taken in Hillman reflects these standards.

29. See "Reply Brief of Petitioner Batavia Nursing and Convalescent Inn," dated August 7, 2003.

30. See supra p. 6, n.11.

31. 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.

32. Mimiya Hospital, DAB No. 1833, at 8 (2002), aff'd, Mimiya Hospital v. Dept. of Health and Human Services, No. 02-1952 (1st Cir. June 9, 2003).

33. CarePlex of Silver Spring, DAB No. 1683, at 17 (1999)(hereinafter, "CarePlex").

34. CMS did not challenge the reduction of the CMP from $700 to $600, so we do not address here whether the reduction was warranted.

35. 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.

36. Batavia's argument is silent on the rest of the provision that requires a facility to 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-vii) (Section 1819(b)(4)(A)(iii-vii) of the Act).

37. After initially stating his intent to rely on the testimony of Ms. Parks to establish the physician's presence in the facility on September 20, Batavia's counsel offered to mark and move the document into evidence. CMS objected due to Batavia's lack of notice and untimely proffer. The ALJ noted CMS's objection and commented that the document's illegibility made it of no value. Batavia then queried Ms. Parks on its purported content. Tr. at 442-43.

38. The surveyor's record review listed nurse notes from September 20 through September 27, including notes indicating the resident was picking at moles and skin as early as September 23 and indicating skin damage due to this behavior on September 25. CMS Ex. 22, at 15. Nurse notes which Batavia submitted into evidence begin on September 26, the day before the physician was notified that the resident had begun tearing at her flesh. P. Ex. 4, at 8-17.

39. The Secretary has explained that a resident does not have a right to have grievances resolved to his or her satisfaction, only that a facility make "prompt efforts" at grievance resolution. 56 Fed. Reg. 48,826, 48,835 (Sept. 26, 1991).

40. The cited testimony makes no mention of interim beautician services at a nearby facility, and Batavia pointed to no other evidence to bolster this unsupported assertion of counsel.

41. Although unclear, Batavia appears to reference two distinct care plans for this resident: the "care plan in place for cognition and depression" cited here as well as the social services POC cited by Batavia at P. Ex. 7.

42. Under cross-examination, Ms. Tucker testified that verbalization of feelings was a goal pertaining to the resident's physical pain, not mental or emotional pain related to grief. Tr. at 307. This testimony is consistent with the relevant portion of Ms. Tucker's notes, which state:

"- padded SR - use of device will not result in [decrease] in physical, emotional/psychosocial status
- will be free of pain maintain comfort [with] assist as needed
- will be free of adverse effect [related to] use of [anticoagulant]
- will be free of pain [with] interaction as needed [as evidenced by] verbalizes relief."

CMS Ex. 22, at 21 (emphasis added); Tr. at 306-07.

43. The ALJ found that CMS failed to establish prima facie cases for examples under this deficiency involving broken ash tray covers and peeling paint. ALJ Decision at 16-17. CMS did not challenge these findings on appeal.

44. Ms. Guttery's testimony is consistent with the definition provided by Dorland's Illustrated Medical Dictionary, which defines a tracheostomy as "the surgical creation of an opening into the trachea through the neck, with the tracheal mucosa being brought into continuity with the skin; also, the opening so created." Id. at 1739 (27th ed. 1988).

45. The abbreviation "p.r.n." is derived from the Latin term "pro re nata," which means "according as circumstances may require." Dorland's Illustrated Medical Dictionary at 1355 (27th ed. 1988).

46. We have also considered Batavia's arguments that nursing staff attempted to ambulate the resident in relation to toileting and find them insufficient to overturn the ALJ's finding.

47. Batavia did not submit Resident 177's medical records into evidence as an exhibit. CMS submitted two pages of Resident 177's medical records into evidence. CMS Ex. 38.

48. In order to be eligible for Medicare hospice services, an individual must be eligible for Medicare Part A and certified as "terminally ill." 42 C.F.R. §§ 418.20. "Terminally ill means that the individual has a medical prognosis that his or her life expectancy is 6 months or less if the illness runs its normal course." 42 C.F.R. § 418.3. Regulations allow three limited periods of hospice election, then an indefinite duration. 42 C.F.R. § 418.21.

49. "Neglect" is defined as the "failure to provide goods and services necessary to avoid physical harm, mental anguish, or mental illness." 42 C.F.R. § 488.301.

50. Ms. Truett testified that "the resident was seated on a mechanical lift pad, which is a canvas pad that they use to lift the resident from the bed to the chair." Tr. at 33. The reference to a "mechanical lift" appears to refer to the use of a Hoyer lift for transfers. CMS Ex. 37, at 1.

51. Batavia witness Carol Watson, LPN, stated that with neurogenic bladder, an individual would not "have control over the bladder. They have spasms." According to Ms. Watson, "[e]ven if you changed her and turned her she would urinate again. She was wet frequently." Tr. at 432.

52. Presumably, the "spots in question" were the wounds noted on the resident's buttocks and coccyx. See infra p. 53.

53. Ms. Truett testified that in addition to the pressure sore identified by the facility on the resident's coccyx, she observed Stage I and Stage II pressure sores on the resident's right and left buttocks that had not been documented. Tr. at 35-36, 38. Ms. Truett described a Stage I "pressure sore as a persistent area of redness." A Stage II pressure sore involves "a superficial loss of tissue" and is "open, but not deep." A Stage III pressure sore is "deeper than a stage two, and involves at least a partial thickness of the underlying tissue." A Stage IV pressure sore "is a full loss of tissue that can involve the muscle and reach the underlying bone." ALJ Decision at 28, n.8; Tr. at 36.

54. While the dates of Ms. Watson's entries are cut off, it appears that two were made on "20" and another on "27." Id. While unclear, it seems that these entries may have been made on the last day of the survey, October 20, with a followup entry for resolution of the right thigh wound on October 27. This conclusion is consistent with an "Active Skin Problem POC" pertaining to a dry scab on the right thigh, dated on October 20, with target resolution date of October 27. P. Ex. 27, at 26.

55. "Your request for review must include a written brief specifying findings of fact and conclusions of law with which you disagree, and your basis for contending that each such finding or conclusion is unsupported or incorrect. . . ." Guidelines, ¶ 2(c)(emphasis added); see also 42 C.F.R. § 498.82(b).

56. Resident 106 was also the subject of deficiencies in the ALJ Decision under F-Tags 309, 315, 441, and 514 (FFCLs 8, 12, 19, and 21) concerning anti-embolism hose, catheterization, cross-contamination infections, and clinical recordkeeping. Resident 177 was the subject of deficiencies under F-Tags 311, 324, and 514 (FFCLs 9, 14 and 21) concerning a decline in ambulatory function, falls, and clinical recordkeeping. Batavia cross-referenced arguments for these citations that are irrelevant to the incontinence care at issue here.

57. The ALJ found that CMS failed to establish a prima facie case under this deficiency for Resident 32. ALJ Decision at 37. CMS did not challenge this finding on appeal, which we therefore leave undisturbed.

58. As previously noted, Batavia submitted no clinical records into evidence for Resident 177, and CMS submitted two pages from the resident's records. See supra p. 45, n.47, citing CMS Ex. 38. CMS's submission does not provide clinical documentation for the factual bases of this deficiency.

59. The ALJ noted that prior to July 2, the resident had been ambulating without difficulty, and, therefore, he rejected the CMS finding that the facility should have had a fall prevention plan before that date. ALJ Decision at 34.

60. The regulations have since been amended to permit challenge to the level of noncompliance where it would affect "a finding of substandard quality of care that results in the loss of approval for . . . a nurse aide training program." 42 C.F.R. § 498.3(b)(14)(ii).

61. CMS may select a CMP from two ranges: a Category 2 CMP falls within a range from $50 to $3,000 per day, while a Category 3 CMP falls within a range from $3,050 to $10,000 per day. A Category 3 CMP is imposed for deficiencies that constitute immediate jeopardy to resident health or safety. 42 C.F.R. § 488.438(a)(i); see also SOM, Ch. 7, § 7400E.1.

62. We do not read the ALJ's reference to the resident's bruising and pain on August 4 as actual harm to be a finding by the ALJ on the severity of the deficiency as much as a review of the factual underpinnings of CMS's prima facie case. ALJ Decision at 35.

63. The ALJ Decision refers to a restraint-free alarm as "tether alarm." The surveyor described it as a "3" by 4" device (box) that is attached to a solid surface by way of a velcro, clip or hook. The string connected to the box is attached to the resident's clothing so that when the resident rises or moves enough to stretch the string taut, it snaps out of the box and [the] alarm sounds." ALJ Decision at 35-36, n.9; Tr. at 49.

64. The medical records submitted into evidence by Batavia do not contain a September 20 entry on this incident. P. Ex. 13, at 26. The records do note a new order from the physician the following day, that the top half side rails of the resident's bed were to be raised to remind the resident to request assistance with ambulation, due to "forgets unable to amb. unassisted [due to] dementia." Id.

65. The records reflect three late entries, all dated October 30.

66. Surveyor Fran Tucker explained that "[e]ach resident has a pharmacy review where the pharmacist reviews the medication the resident is currently on and makes recommendations either to the physician or to the facility. In this particular [incident] this was the documentation from the paper that the pharmacist reviewed the record for appropriateness of the medication." Tr. at 309.

67. We note that while the record is unclear, this resident appears to have been referred to hospice care on July 22, 2000, following hospitalization for pneumonia. CMS Ex. 22, at 19; Tr. at 264, 459. An interdisciplinary care plan submitted into evidence by Batavia reveals that the resident was on hospice care a year later, on July 17, 2001. P. Ex. 7, at 2. Nothing in these documents establish that this resident was a hospice patient at the time of the October 2000 survey, however. Indeed, the July 2001 care plan, which indicates that the resident was then receiving hospice services, requires that the effectiveness of prn medications be noted. Id.

68. Surveyor Guttery testified that a plate guard is "typically a metal half-circle shape that clips on the sides of the plate and it acts as a backstop for food." Tr. at 343. Ms. Guttery testified that if the plate guard had been positioned on the front of the plate, "as he scooped his food [the plate guard] would have caught the food and assisted it onto the spoon [and it] would have been more effective." Id.; ALJ Decision at 42.

69. Batavia also argued that the ALJ erred by applying the Hillman burden of proof analysis in this case. As previously discussed, we find no error in this application.

70. The term "nosocomial" is defined as "pertaining to or originating in the hospital; said of an infection not present or incubating prior to admittance to the hospital, but generally occurring 72 hours after admittance. . . ." Dorland's Illustrated Medical Dictionary at 1151 (27th ed. 1988).

71. MRSA is an acronym for "methicillin-resistant staphylococcus aureus." "Caused by Gram-Positive Cocci," The Merck Manual of Diagnosis and Therapy, Sec. 13, Ch. 157 (Mark H. Beers, M.D. & Robert Berkow, M.D., eds., 17th ed. 1999).

72. To evaluate the reasonableness of the amount of a CMP, the ALJ considers factors set forth in 42 C.F.R. § 488.438(f). Livingston Care Center, DAB No. 1871, at 23-24 (2003), citing CarePlex. 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, and the facility's "culpability." 42 C.F.R. § 488.438(f).

73. Of the 19 deficiencies upheld by the ALJ, nine were repeated deficiencies, including the two Level G deficiencies.

74. We note that Batavia's pleadings, while less than clear, meet the regulatory requirements of 42 C.F.R. § 498.40(b). We have previously permitted a challenge to CMP amount when petitioner pled that imposition was "inappropriate and unfair" due to lack of culpability and, in a subsequent filing, then claimed that the CMP was "unreasonable." See CarePlex of Silver Spring, DAB No. 1627, at 23-24 (1997).

CASE | DECISION | ANALYSIS | JUDGE | FOOTNOTES