CASE | DECISION | ANALYSIS | JUDGE | FOOTNOTES

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


SUBJECT: The Windsor House,

Petitioner,

DATE: August 31, 2004

             - v -
 

Centers for Medicare & Medicaid Services

 

Docket No. A-03-88
Civil Remedies CR1039
Decision No. 1942
DECISION
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FINAL DECISION ON REVIEW OF
ADMINISTRATIVE LAW JUDGE D
ECISION

The Windsor House (Windsor or Petitioner) appealed a May 12, 2003 decision by Administrative Law Judge (ALJ) Alfonso J. Montano affirming the determination by the Centers for Medicare & Medicaid Services (CMS) to impose civil money penalties (CMPs) against Windsor for failure to comply substantially with Medicare participation requirements. Windsor House, DAB CR1039 (2003)(ALJ Decision). The ALJ upheld a CMP of $5,000 per day for six days of immediate jeopardy to resident health and safety, from November 18 through November 23, 1998. The ALJ also affirmed CMPs of $1,000 per day for 17 days of non-immediate jeopardy, from November 24 through December 10, 1998, and $250 per day for six days of non-immediate jeopardy, from December 11 through December 16, 1998. ALJ Decision at 1; CMS Ex. 61, at 1. (1)

We conclude that except for minor modifications and our reversal of the FFCL 1 deficiency involving Resident 5, the ALJ's findings are supported by substantial evidence in the record as a whole and without legal error. We affirm the ALJ Decision and sustain the CMP imposed.

Background

Legal Background

Windsor is a skilled nursing facility (SNF) in Tennessee that participates in the Medicare program. To participate in Medicare, a SNF must meet the requirements set forth in 42 C.F.R. Part 483. A facility's compliance with these participation requirements is verified through the survey, certification, and enforcement processes described in 42 C.F.R. Part 488, Subparts E and F.

Surveys are usually conducted by a state agency under an agreement with CMS. A survey's findings are presented in a Statement of Deficiencies (CMS 2567), which identifies each instance of noncompliance with a participation requirement. See CMS State Operations Manual (SOM) Appendix (App.) P, Chap. IV. Each deficiency, or failure to meet a participation requirement, is identified by an alpha-numeric "tag" corresponding to the section of the regulation in 42 C.F.R. Part 483 which contains that requirement. Id.

The survey agency and CMS rate the seriousness (or level of noncompliance) of each reported deficiency by determining its scope and severity. (2) See 42 C.F.R. § 488.404. Scope refers to whether the deficiency is widespread, isolated, or constitutes a pattern. See 42 C.F.R. § 488.404(b)(2); SOM App. P, § V.C. Severity refers to the magnitude of the harm or potential harm to resident health and safety. See 42 C.F.R. § 488.404(b)(1); SOM App. P, § V.B. For example, a deficiency may cause immediate jeopardy to resident health or safety, actual harm that is not immediate jeopardy, no actual harm but a potential for more than minimal harm, or no actual harm with a potential for minimal harm. Id.

A facility becomes subject to remedial actions by CMS when it is not in substantial compliance with participation requirements. 42 C.F.R. § 488.400. Substantial compliance means "a level of compliance . . . 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.

If a survey reveals that a facility is not in substantial compliance, CMS may either terminate the facility's provider agreement or, if the facility submits an acceptable plan of correction (POC), allow it to continue its participation for no longer than six months. 42 C.F.R. §§ 488.402(d), 488.408(f), 488.412. Even if a POC is approved, the facility may not be regarded as in substantial compliance until the survey agency determines, following an onsite revisit or other verification procedure, that the deficiencies no longer exist. 42 C.F.R. §§ 488.440(g)-(h), 488.454(a); SOM § 7316.

To encourage facilities to implement a POC, CMS may impose intermediate sanctions, in the form of CMPs, for the days in which the facility remains in a state of noncompliance. Noncompliance under the regulations means "any deficiency that causes a facility to not be in substantial compliance." 42 C.F.R. § 488.301. To impose a CMP, CMS must send the facility a written notice of penalty that describes the nature of the noncompliance, the statutory basis for the CMP, the facility's right to a hearing, and other information. 42 C.F.R. § 488.434.

A CMP may be imposed for two categories of noncompliance. See 42 C.F.R. §§ 488.408(d)-(e), 488.438. For deficiencies that constitute immediate jeopardy and for some repeated deficiencies, the regulations permit a per day CMP of $3,050 to $10,000. 42 C.F.R. § 488.438(a)(1). For deficiencies that do not constitute immediate jeopardy but that cause actual harm or the potential for more than minimal harm, the regulations allow a per day CMP of between $50 and $3,000. 42 C.F.R. § 488.438(a)(ii). A 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).

CMS's choice of remedy and the factors that it considers in selecting the CMP as a remedy are not subject to appeal. 42 C.F.R. §§ 488.438(e), 488.408(g)(2). The facility may, however, appeal the noncompliance findings leading to the imposition of a remedy. 42 C.F.R. §§ 488.438(e)(1), 488.408(g)(1). The facility may also challenge whether the amount of the CMP is "reasonable," which 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).

The Surveys

The Tennessee Department of Health (TDH) conducted a survey at Windsor from November 16-18, 1998. P. Ex. 2, at 1. As a result, TDH cited Windsor for ten deficiencies, including multiple examples, as reflected on the CMS 2567. P. Ex. 1. The most serious of those deficiencies was F-Tag 325 (acceptable parameters of nutritional status), cited at Level K as constituting a pattern of deficiencies that caused immediate jeopardy to resident health or safety. Id. at 7. TDH also cited Windsor for three deficiencies at Level D, five at Level E, and one at Level F. Id.

Windsor submitted a POC, alleging that it would achieve substantial compliance by November 24, 1998. P. Ex. 1; see also SOM § 7317.A (POC as allegation of compliance). By letter dated November 25, TDH advised Windsor that it would recommend certain remedies for the noncompliance, including a CMP of $5,000 per day (effective November 18). P. Ex. 2, at 1.

On December 9-10, 1998, TDH conducted a revisit survey at Windsor and determined that Windsor had yet to achieve substantial compliance with program requirements. P. Ex. 4, at 1. During the revisit, TDH cited Windsor for four deficiencies, the most serious being F-Tag 309 (quality of care), cited at Level G as constituting an isolated incident of actual harm that was not immediate jeopardy. P. Ex. 3, at 3. TDH also cited Windsor for one deficiency at Level D and two deficiencies at Level E. See P. Ex. 3. (3) During the revisit, TDH advised CMS that immediate jeopardy had been removed as of November 24, 1998. CMS Ex. 25, at 1.

Windsor again submitted a POC, alleging that it would achieve substantial compliance by December 11, 1998. P. Ex. 3. By letter dated December 15, TDH advised Windsor that it would recommend a decreased CMP of $1,000 per day (effective November 24, 1998) for noncompliance cited during the revisit. P. Ex. 4, at 1.

TDH conducted a followup survey on January 13, 1999, and determined that Windsor had achieved substantial compliance with program requirements as of December 17, 1998. CMS Ex. 26, at 2; CMS Ex. 61, at 1. CMS imposed a decreased CMP of $250 per day for noncompliance between December 11-16. CMS Ex. 61, at 1. The CMPs imposed are thus as follows:

$5000/day, November 18 through November 23 (6 days)
$1000/day, November 24 through December 10 (17 days)
$ 250/day, December 11 through December 16 (6 days)

The aggregate CMP totals $48,500. Cf. Tr. at 6.

The ALJ Decision

On January 19, 1999, Windsor requested an ALJ hearing, disputing TDH's determination that Windsor had not been in substantial compliance with program requirements and the imposition of a CMP. CMS Ex. 26. An evidentiary hearing before ALJ Montano was held on July 25-27, 2000. ALJ Decision at 2.

The ALJ Decision contains 14 numbered Findings of Fact and Conclusions of Law (FFCL) in Section III.B. Id. at 5-26. (4) The factual and legal bases for the deficiencies in the November survey are in FFCLs 1-9 (id. at 6-21) and for the December revisit survey in FFCLs 10-13 (id. at 21-25). The ALJ upheld the total CMP as reasonable in FFCL 14. Id. at 26.

Issues

In a Memorandum of Law supporting its Request for Review (collectively herein, Request for Review or RR), (5) Windsor argued that FFCLs 1, 2, 5, 6, 7, 9, 10, 11, 12, 13, and 14 were not supported by substantial evidence on the record as a whole. RR at 26-27. (6) Windsor also contended that the ALJ committed six procedural errors. Briefly, the alleged errors related to the ALJ's application of a "clearly erroneous" standard of review, discussion of residents not specifically cited in the CMS 2567, admission of supplemental exhibits and hearsay evidence, evaluation of culpability, findings of repeated deficiencies, and allocation of burden of proof on CMP reasonableness. Id. at 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)(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, an ALJ need not "cite to everything in the record which supports" the findings, but 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 ALJ committed procedural errors as argued by Windsor. We then discuss whether substantial evidence and applicable law supports the FFCLs appealed. We conclude by discussing whether the CMP amounts are reasonable.

The facts included in our discussion provide a framework for understanding the ALJ Decision and are not a substitute for his findings. In reviewing this case, although we do not discuss in detail every argument presented, we have nonetheless reviewed and considered each and every point in the parties' pleadings. (7)

1. The ALJ committed no procedural error with respect to burden of proof, uncited residents, or the admission of supplemental exhibits and hearsay evidence. (8)

A. The ALJ committed no error with respect to the burden of proof or the admission of hearsay evidence.

Windsor first alleged that the ALJ applied a clearly erroneous standard in reviewing the evidence submitted. RR at 2, 27. Windsor also argued that the ALJ relied "solely upon the Statement of Deficiencies as evidence to support CMS's findings" while "ignoring the documentary evidence that contradicted the conclusions and opinions of the surveyor." RR at 75-76; Reply at 1-2. As support, it cited ALJ Leahy's decision in Gold Country Health Center, CR533 (1998) as having "materially altered post-Hillman" the evidence required "to support a decision." RR at 76; Reply at 1. Windsor cited no particular deficiency in connection with this argument. RR at 76-78.

We note, however, that the ALJ correctly stated the applicable burden of proof set out in Hillman Rehabilitation Center, DAB No. 1611 (1997)(Hillman), aff'd Hillman Rehabilitation Center v. United States, No. 98-3789 (GEB) (D.N.J. May 13, 1999), (9) and adopted for CMP cases in Cross Creek Health Care Center, DAB No. 1665 (1998) and Batavia Nursing and Convalescent Center, DAB No. 1904 (2004)(Batavia I). (10) Contrary to Windsor's contentions, Hillman remains unaltered by the ALJ's decision in Gold Country. Gold Country at 17 (setting out Hillman conclusions). ALJ Leahy interpreted those standards to conclude that "[t]he evidence submitted by CMS to establish its prima facie case needs to be material to the correct interpretation of the pertinent legal authorities." Id. She pointed out that the "body of evidence" submitted by CMS should not be internally inconsistent, should not give rise to "material questions of fact," should be credible on its face, and should lead reasonably and persuasively to the factual basis of the citations. Id. at 40. This interpretation is consistent with Hillman's explanation that CMS must establish a prima facie case (through undisputed facts and evidence on disputed facts) that is "legally sufficient under the statute and regulations." Id., citing Hillman at 11. CMS must "establish that the factual allegations raised [in the CMS 2567] are legally sufficient and are not simply asserted without some evidentiary basis." Meadow Wood Nursing Home, DAB No. 1841, at 7 (2002), aff'd, Meadow Wood Nursing Home v. HHS, 364 F.3d 786 (6th Cir. 2004).

The ALJ also correctly stated that the clearly erroneous standard applies in CMP cases to "CMS's determination as to the level of noncompliance . . . ." ALJ Decision at 2; 42 C.F.R. § 498.60(c). Our review of the ALJ Decision and the record as a whole thus supports the conclusion that the ALJ correctly articulated and applied the burdens of proof and the regulations concerning challenges to the level of noncompliance in a CMP case. We reject Windsor's arguments to the contrary.

We also reject Windsor's arguments that the ALJ improperly relied upon hearsay evidence in the CMS 2567 and certain CMS exhibits. RR at 76-77. Windsor pointed to no purported hearsay statement, in the CMS 2567 or CMS exhibits, to which it objected. The ALJ correctly explained that hearsay evidence is admissible and accorded weight to the extent reliable. ALJ Decision at 3; Omni Manor Nursing Home, DAB No. 1920, at 16-18 (2004) (citations omitted)(hearsay evidence admissible and weighed consistent with indicia of reliability).

We address Windsor's arguments about the ALJ's purported reliance upon the CMS 2567 as evidence in our discussion of "Other Residents" under FFCL 1.

B. The ALJ committed no error with respect to "uncited residents."

Windsor contended that the ALJ admitted and relied upon "evidence concerning residents who were never cited" in the CMS 2567. According to Windsor, the use of this evidence "referring to" the uncited residents "cannot be anything other than a due process violation." RR at 78. Windsor maintained, generally, that this practice failed to provide it with adequate notice of the contested issues.

The ALJ noted that Windsor objected to exhibits "for residents that were not cited in the relevant surveys in this case . . . ." He conducted a pre-hearing conference on Thursday, July 20, 2000, and ordered CMS to file a document correlating each such resident to the relevant deficiency in the CMS 2567, which CMS did that day. ALJ Decision at 4. The hearing began on Tuesday, July 25, 2000. Id. at 2.

The document that CMS filed on July 20 lists nine exhibits. (11) CMS explained that three (CMS Exs. 44, 47, and 59) were not submitted to support a deficiency, but to show a lack of CMS bias. The remaining six (CMS Exs. 38, 39, 41, 53, 56, and 57) relate six residents (Residents 3, 4, 6, 18, 21, and 22) to F-Tags 164 (privacy curtains), 325 (parameters of nutritional status), 353 (sufficient nursing staff), and 441 (infection control).

Windsor indicated that the ALJ relied upon or discussed two challenged exhibits in reaching his findings. Reply at 11, n.9, citing ALJ Decision at 15-16 and CMS Exs. 38, 47. CMS Exhibit 38 concerns Resident 3 and discusses inadequate privacy curtains (F-Tag 164). ALJ Decision at 15. For F-Tag 164, the CMS 2567 identifies deficient practices by resident room number, including Room 34. P. Ex. 1, at 2. Resident 3 resided in Room 34 during the survey. CMS Ex. 30, at 15. As Windsor's POC reflects that it ordered a new privacy curtain for Room 34 (P. Ex. 1, at 1), we find Windsor's objection to the ALJ's admission of and citation to CMS Exhibit 38 (in relation to privacy curtains and Resident 3) lacking in merit.

CMS Exhibit 47 pertains to unclean nasal cannula in Room 56. Reply at 11, n.9; P. Ex. 1, at 4. The POC states that "[t]he nasal cannula in room 56 has been replaced." P. Ex. 1, at 4. This deficiency was cited under F-Tag 252 and was discussed by the ALJ in FFCL 3. ALJ Decision at 16. As Windsor elected not to appeal FFCL 3 (see RR at 26), we thus find this contention irrelevant. Even if it were relevant (and it is not), Windsor clearly demonstrated in its POC that it was able to determine the nature of the alleged violation with the room number. (12)

Windsor also alleged that Resident 2 was "never cited" in the CMS 2567 and argued that Windsor was not provided notice of the relevant issues before hearing testimony, thus denying it due process of law. RR at 13 n.8, 19, 49-53. The ALJ addressed this argument, noting that Windsor first raised it in a footnote in its post-hearing brief. ALJ Decision at 3-4. The ALJ explained that Windsor exchanged initial and supplemental exhibits on Resident 2 with CMS, conducted cross-examination, and offered a "reasoned and informed" argument in its post-hearing filings. Id. at 4. We agree with the ALJ that Windsor was "fully informed of the issues and regulatory violation . . . prior to the hearing." Id. We find no procedural or due process error regarding Resident 2.

C. The ALJ did not err in admitting CMS's supplemental exhibits.

Windsor maintained (without any accompanying explanation) that the ALJ's admission and reliance upon 33 "supplemental exhibits" submitted by CMS six weeks before the hearing, after the initial deadline for exhibits, constituted error "extremely prejudicial to The Windsor House . . . ." RR at 2, 75. Windsor did not contest that the ALJ held a prehearing conference on this issue, admitted the exhibits, and continued the hearing date by approximately six weeks to cure any prejudice to Windsor. See RR at 2, 12; ALJ Decision at 3 (hearing "rescheduled to allow Petitioner time to review and analyze the additional exhibits."); see also "Ruling on [CMS'] Motion to Supplement Proposed Exhibit List and Exhibits," dated May 26, 2000 (Pre-Hearing Ruling)(June 13, 2000 hearing continued to July 25, 2000).

The transcript also indicates that counsel for Windsor conceded this issue at the hearing. "On the 33 supplemental exhibits, I think that your ruling gave the opportunity to cure obviously, because it gave us notice of the exhibits and an opportunity to rebut." Tr. at 10. As we have held, an issue that is either conceded or uncontested at the hearing may not be raised on appeal. Clermont Nursing and Convalescent Center, DAB No. 1923, at 26-27 (2004), citing Omni at 45; Ross Healthcare Center, DAB No. 1896, at 11 (2003). Even if this were an appealable issue (and it is not), we find that in this instance, the ALJ's admission of the supplemental exhibits in conjunction with his curative ruling raises no due process concerns.

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

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

A. The November 18, 1998 Survey.

FFCL 1. Petitioner was not in substantial compliance with the regulation concerning nutrition, at an immediate jeopardy level, during the November 18, 1998 survey. 42 C.F.R. § 483.25(i)(1).

A facility's obligations regarding quality of care and acceptable parameters of nutritional status are set forth in 42 C.F.R. § 483.25(i)(1), which states:

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.

* * * * *

(i) Nutrition. 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 . . . .

Id. TDH cited this deficiency under F-Tag 325, at Level K. P. Ex. 1, at 7. The CMS 2567 states that "the facility failed to ensure that the nutritional status of residents was not severely compromised as evidenced by an overall systems failure that ensures [sic] residents who require assistance with feeding are fed and that residents who require nutritional supplements receive those supplements" for 13 of 31 sampled residents. Id.

The ALJ first found that testimony provided by TDH witness and surveyor Alice Ray was credible and deserving of greater weight than the testimony of Windsor witnesses Pamela Franks, Sherry Pippin, and Glenda Duke. He made this finding based on Ms. Ray's extensive "training and experience" as a dietitian and state surveyor. ALJ Decision at 6. The ALJ then stated that CMS could establish its prima facie case by showing multiple factors, including an "unplanned severe" weight loss. He rejected Windsor's argument that CMS had to show symptoms of malnutrition or that the resident's clinical condition made compliance possible. Instead, he noted that Windsor bore the burden of proving that the resident's clinical condition made compliance impossible. The ALJ concluded that CMS had shown Windsor's "generalized failure" to comply with the regulatory requirement, based on the presence of multiple factors. ALJ Decision at 6-8.

On appeal, Windsor argued that the ALJ erred in finding the testimony of Ms. Ray more credible than that of the Windsor witnesses, as she had no experience in "nursing/medicine or the long-term care area . . . ." Windsor also argued that the ALJ improperly applied a strict liability standard. Windsor further argued that the residents' clinical conditions made compliance with the nutrition regulation impossible. Windsor finally argued that the surveyors made no finding of malnutrition, findings required by the SOM. RR at 13-14, 20-21, 21 n.14, 29-31.

Windsor offered no compelling reason to overturn the ALJ's credibility and weight determinations for testimony by TDH surveyor Alice Ray.

We generally defer to an ALJ's determinations of weight and credibility of testimony, absent a compelling reason to the contrary. Batavia I at 27, citing Koester Pavilion, DAB No. 1750, at [14] (2000). We have concluded that such deference is warranted because -

[a] reviewing panel does not have the opportunity to evaluate the credibility of a witness by listening in person to the witness's testimony or observing the witness's demeanor. The evaluation of the credibility of a witness is properly left to the hearing officer . . . . Thus, we defer to the ALJ's evaluations of the credibility of the witnesses who appeared before him in this matter.

Georgian Court Nursing Center, DAB No. 1866, at 17 (2003), citing South Valley at 22.

We have noted that the testimony of facility staff may sometimes merit greater weight than the "observations, record review, and testimony provided by qualified state surveyors. . . ." Batavia I at 27.

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

Id. at 26.

After reviewing the transcript of the hearing, we find no reason to question the ALJ's judgment. Ms. Ray's education, training, and extensive experience as a dietitian and surveyor were detailed before the ALJ and subject to voir dire examination by Windsor counsel. Tr. at 82-100. Among other credentials, Ms. Ray was a registered dietitian in the American Dietetic Association (ADA), of which she had been a member for 26 years. Tr. at 82-83. As a registered dietitian in the ADA, she meets the regulatory definition of a "qualified dietitian." 42 C.F.R. § 483.35(a)(2). (13) Long-term care facilities must employ a qualified dietitian on a full-time, part-time, or consulting basis. 42 C.F.R. § 483.35(a). This designation establishes that the ALJ properly accorded great weight to Ms. Ray's testimony regarding Windsor's alleged violations of the participation requirements relating to nutrition. We therefore reject Windsor's challenges based upon Ms. Ray's purported lack of experience in the long-term care industry. We also find that Ms. Ray's experience since 1984 as a surveyor for TDH reflects sufficient exposure to the long-term care industry to support the ALJ's determinations. Tr. at 88-91.

In reaching this conclusion, we have also considered and reject Windsor's multiple assertions that Ms. Ray's testimony contains purported inconsistencies with record evidence or with her notes taken during the survey. See, e.g., RR at 55-56. We find in our review of the record as a whole no compelling reason to overturn the ALJ's weight and credibility determinations.

Windsor bears the burden of proving that residents' clinical conditions made the maintenance of adequate nutritional status impossible.

The ALJ stated that "unplanned severe weight loss" is one factor in considering whether CMS has established a prima facie case. ALJ Decision at 6. He noted that the parties did not dispute that severe weight loss could be established by a loss of "more than 5% of body weight in one month," 7.5% in three months, and 10% in six months. Id. at 6-7. (14) He then listed other factors which, when considered with such weight loss, support an inference of noncompliance with the regulatory requirement:

whether a resident has fallen below his ideal body weight while under Petitioner's care; whether Petitioner has failed to assist residents who required assistance while eating; whether physician's orders for nutritional supplements were disregarded; whether residents had low protein levels as indicated by a low albumin level; whether Petitioner was slow to react to significant weight loss; whether Petitioner failed to follow its own policies of weekly weighing a resident who has had a significant weight loss; whether Petitioner failed to follow the recommendations of its own dietician concerning a resident who has had a significant weight loss; whether Petitioner stopped trying new interventions for a resident who was experiencing severe weight loss; whether Petitioner discontinued nutritional supplements without providing a substitute for the discontinued supplements for a resident who has had a significant weight loss, and not taking a resident's food preferences into account for a resident who has had a significant weight loss.

ALJ Decision at 7. (15)

Windsor argued that the "presence of clinical conditions is sufficient to establish that it was not possible to maintain acceptable nutritional status" and that the ALJ erred by "dismiss[ing] the clinical conditions . . . ." RR at 21. Windsor then argued that the ALJ's recognition that the regulation uses the word "ensure" means that the ALJ "intended to impose a strict liability standard . . . ." Id. at n.14.

The nutrition regulation states: "Based on a resident's comprehensive assessment, the facility must ensure" maintenance of "acceptable parameters of nutritional status . . . unless the resident's clinical condition demonstrates that this is not possible." 42 C.F.R. § 483.25(i)(1)(emphasis supplied). The Board has addressed this regulation in Carehouse Convalescent Hospital, DAB No. 1799 (2001) where we held:

The regulation does not require that a facility maintain a resident's weight at a fixed level, or hold a facility strictly liable for a resident's weight loss in all cases except where maintenance of the resident's weight is clinically impossible. By its language the regulation requires maintenance of weight only to the extent that weight is a parameter of nutritional status. Where a resident receives adequate nutrition and weight loss is due to non-nutritive factors, then weight may not be a parameter of nutritional status, and weight loss by itself does not provide a basis for a deficiency finding.

Id. at 21.

Weight loss, however, "may raise an inference of inadequate nutrition and support a prima facie case of a deficiency." Carehouse at 22. A facility can rebut a prima facie case based upon weight loss "by a preponderance of the evidence, [showing] that it provided the resident with adequate nutrition." Id. This allocation of the burden of proof is supported by the commentary to the final rule. "[T]he facility [may] direct surveyor attention to any evidence (the resident or the resident's clinical record)" to show that negative care outcomes, such as unplanned weight loss, are unavoidable. 54 Fed. Reg. 5316, 5332 (February 2, 1989).

In reaching these conclusions, the Board reviewed the evolution of the regulation. CMS "initially 'proposed that a facility must ensure that a resident does not lose weight'" without justifiable cause and had to receive "a special therapeutic diet when there is a nutritional problem." Carehouse at 21, citing 54 Fed. Reg. 5316, 5335 (1989). In response to comments, CMS modified the language to shift the focus from weight loss to the facility's obligation to ensure "acceptable parameters of nutritional status." Id., citing 54 Fed. Reg. 5316, 5335-36. In light of this history, we then concluded that "weight loss should not be the basis of a deficiency finding where it is not attributable to the failure to provide sufficient nutrition." Id.

As Carehouse explains, the resident's clinical condition can make it impossible for a facility to provide nutrition adequate to the resident's needs.

[T]he regulation provides that the only circumstance under which a facility is not responsible for ensuring that a resident maintain adequate parameters of nutritional status is where the resident's clinical condition demonstrates that this goal is impossible. However, if a facility can demonstrate that it provided adequate nutrition such that a resident's weight loss is not a parameter of nutrition, then it has demonstrated substantial compliance with the regulation and is not required to show that this narrow exception applies. . . . It is only where a facility cannot establish that it provided adequate nutrition that it must demonstrate that the resident's clinical condition made such a goal impossible (for example, where the resident was suffering from throat cancer, and his family refused to consent to the use of a feeding tube).

Id. at 22 (citations omitted).

Thus, we made it clear that a facility retains the ability to rebut a deficiency finding based on a resident's weight loss by a preponderance of the evidence demonstrating that it provided adequate nutrition or that the weight loss was attributable to non-nutritive factors. As noted in Carehouse, the regulation does not impose strict liability for weight loss or require maintenance of any given weight level. While the ALJ correctly noted here that the regulation uses the word "ensure," there is no indication that he ignored the standard of reasonableness inherent in the phrase "acceptable" parameters of nutritional status. (16)

Instead, the facility is responsible for taking all reasonable steps to ensure that the resident receives nutrition adequate to his or her needs. If CMS relies on weight loss as evidence of a deficiency, the facility may present rebuttal evidence that the resident did receive adequate nutrition or that the weight loss is due to non-nutritive factors, such as a clinical condition.

Carehouse and the commentary to the regulation make clear that the clinical condition exception is a narrow one (17) and applies only when the facility can demonstrate that it cannot provide nutrition adequate for the resident's overall needs, so the weight loss is unavoidable. As the ALJ recognized, "the mere presence of a significant clinical condition, without additional evidence, does not prove that maintaining acceptable nutritional status is not possible." ALJ Decision at 9-10. The ALJ's review of the evidence and argument submitted by Windsor for each resident concerning weight loss and clinical conditions makes clear that he neither imposed nor applied a strict liability standard, but was relying on Windsor's own assessment of the resident's nutritional needs and whether it met its own plan for how to meet those needs. (18)

Windsor also argued that the regulation requires only that it ensure the provision of "basic treatment and services and not toward ensuring residents did not experience unplanned weight loss." RR at 32, citing 56 Fed. Reg. 48,826, 48,850. As we have explained, the quality of care regulation imposes an "overarching duty" on facilities to provide "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." Windsor Health Care Center, DAB No. 1902, at 16 (2003), citing 42 C.F.R. § 483.25. The regulation focuses not on the type of care or services to be provided, but "imposes on facilities an affirmative duty designed to achieve favorable outcomes to the highest practicable degree." Id. at 16-17, citing Woodstock Care Center, DAB No. 1726 (2000), aff'd Woodstock Care Center v. Thompson, No. 01-3889 (6th Cir. 2003); 42 C.F.R. §§ 488.26(c)(2)(resident outcome as determinant of compliance), 488.110 (survey process emphasizes resident outcomes). The regulatory intent is "to focus on evaluating actual facility performance in meeting the purposes of the program and to move away from simply imposing checklists of capacities and services that must be available." Koester at 25-26, citing Woodstock at 28-29. The quality of care standard does not impose strict liability or make the facility a guarantor of favorable outcomes, (19) but requires instead that the facility take "reasonable steps" and "practicable measures to achieve that regulatory end." Clermont at 21, citing Josephine Sunset Home, DAB No. 1908, at 14 (2004).

These conclusions are consistent with the portion of the commentary provision that Windsor did not cite: "We believe that the current wording of this section acknowledges the limitations imposed by . . . recognized pathology and the normal aging process by enabling the facility to demonstrate that based on available clinical evidence, a negative resident care outcome was unavoidable." 56 Fed. Reg. 48,826, 48,850 (Sept. 26, 1991) (emphasis supplied). We thus reject Windsor's assertion that the provision of "basic treatment and services," without regard to outcome, is sufficient.

Having addressed Windsor's general objections, we now turn to its specific challenges. We affirm the ALJ's findings as to Residents 1, 14, 15, 2, 7, 16, 17, and 26-31, and reverse his findings as to Resident 5.

Resident 1

The ALJ described how this then 66 year old resident weighed 121 pounds upon admission and 78 pounds by the time of the survey, 23 months later. This reflects a loss of 43 pounds, or 35.5% of body weight. Facility records indicated an ideal body weight of 96-125 pounds. During this period, the resident sustained multiple instances of "severe" weight loss, but also periods of weight gain. According to the ALJ, the facility failed to offer snacks as ordered by the physician and discontinued nutritional supplements during a period of weight loss. The ALJ also noted evidence that the facility failed to consider the resident's former lifestyle and eating history in formulating a plan to permit the resident to eat later in the day. He concluded that the record indicated that while maintaining Resident 1's weight may have been difficult, it was not impossible. ALJ Decision at 8-10.

On appeal, Windsor argued that the resident's clinical conditions of chronic refusal to eat and pressure sores made compliance impossible, despite interventions including mid-morning snacks and nutritional supplements. Windsor also argued that the ALJ erred by finding the testimony of Surveyor Ray more credible than that of Windsor staff. Windsor finally suggested that the ALJ erred by considering weight loss beyond a six-month period. RR at 33-37; Reply at 17.

i. CMS is not limited to considering weight loss within six months prior to the survey.

We first reject Windsor's argument that the ALJ may consider nutritional parameters only within the six-month period "immediately prior to the survey." RR at 36-37; Reply at 22, n.18. Windsor contended that the SOM makes clear "that a six (6) month period is the appropriate time frame to consider when evaluating weight loss." RR at 53-54; Id. at 21, n.14.

The ALJ cited Surveyor Ray's testimony that the agency must evaluate facility compliance "from the last survey to the current survey." ALJ Decision at 9, citing Tr. at 128. This testimony is consistent with regulations that define a "standard survey" as a periodic inspection conducted to determine compliance. 42 C.F.R. § 488.301. The survey agency must conduct a standard survey "not later than 15 months" since the previous standard survey, and the statewide average between standard surveys cannot exceed one year. 42 C.F.R. § 488.308(a),(b)(1). (20) CMS may impose a CMP for noncompliance "going as far back as the date of the last survey." Mountain View Manor, DAB No. 1913, at 12 (2004), citing North Ridge Care Center, DAB No. 1857 (2002).

CMS may also assess a CMP for "past noncompliance," which the SOM defines as noncompliance that the facility corrects prior to the next survey. North Ridge at 11, n.8, citing SOM § 7510; see also 42 C.F.R. § 488.430(b)(CMP for past noncompliance since last standard survey). Windsor did not dispute that the significant and severe weight losses experienced by Resident 1 between February and March, 1998 (9 pounds) qualify as noncompliance. Even if this deficient practice had been corrected by the time of the survey (and we make no such finding), we find no error in the consideration of noncompliance beyond the six-month period prior to the November survey.

As noted, Windsor also complained that the ALJ wrongly relied upon weight loss in 1997, thus violating procedural due process. RR at 33, n.21. Information regarding the weight loss was taken from records placed into evidence by Windsor. P. Ex. 6, at 61. Leaving aside 1997 weight loss, the record reflects a loss of greater than 15% of total body weight (from 91 pounds to 77) during the six-month period from January through June, 1998. This qualifies as a severe weight loss under the SOM. SOM, App. PP, at PP-106. The final weight of 77 pounds is almost 20 pounds below the minimum ideal body weight of 96 pounds established by Windsor's own consultant. See P. Ex. 6, at 61. The 1998 weight loss alone establishes unplanned and severe weight loss. Given the substantial evidence of noncompliance within 1998, we thus find Windsor's due process contention irrelevant.

ii. Windsor has not established that the resident's clinical conditions made compliance impossible.

The ALJ referred to records which reflected two separate periods of weight gain during 1998. According to the ALJ, one of these gains occurred while the resident's pressure sores worsened and while she refused to eat. These gains also occurred despite the resident's diagnosis of "failure to thrive," a condition which the ALJ defined as chronic refusal to eat. Thus, the ALJ rejected Windsor's argument that it was impossible for Resident 1 to maintain acceptable parameters of nutritional status due to her clinical conditions. ALJ Decision at 8. Windsor countered that while a weight gain was documented on January 30, 1998, the resident's pressure sores had developed only on January 28 and thus had not had time to adversely affect the resident's weight. RR at 37, citing P. Ex. 6.

The record does not support that January 28 was the first time the resident was afflicted with a pressure sore. A Stage II pressure sore is documented as present on the resident's left buttocks from December 31, 1997, through March 10, 1998. P. Ex. 6, at 63-64. A Stage I pressure sore is also documented on the resident's left trochanter from December 1997 through May 5, 1998. P. Ex. 6, at 65-66. The ALJ could reasonably conclude that the weight gain, in spite of these long-standing pressure sores beginning prior to January 28, "demonstrated that she was not so clinically compromised that she could not gain weight." ALJ Decision at 8; see P. Ex. 6, at 1, 48, and 49 (nurse entries regarding pressure sores). The ALJ could also reasonably conclude that the resident's weight gain reflected that a diagnosis of failure to thrive did not make compliance impossible.

It is undisputed that the resident lost 43 pounds in less than two years, over a third of her body weight. The ALJ found that the facility failed to adequately adapt meal schedules, nutritional supplements, snacks, and other interventions to provide the nutrition needed. This finding of facility deficiencies is consistent with observations made by the resident's physician, who attributed a five-pound gain in October to greater staff attention. P. Ex. 6, at 35.

Moreover, Windsor offered no rebuttal to Surveyor Ray's testimony that an individual deprived of nutrition, or suffering severe weight loss, is more prone to skin breakdown and pressure sores. Tr. at 106-07. This suggests that pressure sores in and of themselves do not always lead to weight loss, as Windsor contended on multiple occasions, but can actually be caused by that weight loss. We are thus unable to accept as a general matter Windsor's repeated argument that pressure sores have created the nutritional inadequacies at issue, when there is unrebutted evidence to suggest the reverse.

In sum, the burden is on Windsor to demonstrate that it provided adequate nutrition to the resident before the clinical condition exception can apply. We agree with the ALJ that "[t]he mere presence of a significant clinical condition, without additional evidence, does not prove that maintaining acceptable nutritional status is not possible." ALJ Decision at 9-10.

Resident 14

The ALJ described how this then 79 year old resident weighed 95 pounds on her September 22, 1998, admission, which constituted 81% of her ideal body weight. She then lost 11 pounds in her first month at Windsor. The ALJ determined that Windsor failed to properly assess the resident, since her history of alcoholism and anorexia was not reflected in the Minimum Data Set (MDS) used to create the resident's care plan. He also concluded that "[f]ailure to mention such critical information resulted in Petitioner not taking more aggressive measures in R14's case, which might have avoided such a drastic weight loss in R14's first month." The resident's chronic joint pain also created an inability to feed herself and was not mentioned in the facility's nutritional assessment. The ALJ concluded that Windsor was slow to react to the resident's continued weight loss by failing to conduct a nutritional evaluation or offer supplements in a timely manner. He further determined that her multiple clinical conditions did not make maintenance of acceptable nutritional parameters impossible and that facility interventions, including feeding assistance, were intermittent and ineffective. ALJ Decision at 10-11.

Windsor argued that failing to include the resident's alcoholism and anorexia on the MDS does not violate the requirement in the regulation to maintain acceptable nutritional parameters in accordance with a comprehensive assessment, since the care plan regulation does not mention the MDS or require it for creating a care plan. Windsor again challenged Surveyor Ray's lack of experience in long-term care as making her less credible than Windsor witnesses. Windsor also contended that the resident's history of alcoholism had been referenced throughout her medical record and that the facility responded to the resident's nutritional challenges by assessment and interventions at admission. RR at 37-44.

The Social Security Act (Act) requires that long-term care facilities conduct a "comprehensive, accurate, standardized, reproducible assessment of each resident's functional capacity . . . based on a uniform minimum data set" on a designated form. Section 1819(b)(3)(A) of the Act; (21) SOM § 4145.1. The Resident Assessment Instrument (RAI) (22) and Resident Assessment Protocols (RAPs) (23) reflect the minimum data set. SOM, App. R, Introduction (Intro.). Both the MDS and RAPs are components of the resident's comprehensive assessment. Northern Montana Care Center, DAB No. 1930, at 15-16 (2004). Assessment results are "used in developing, reviewing, and revising the resident's plan of care" mandated by the Act. Section 1819(b)(3)(D) of the Act.

We thus reject Windsor's argument that the MDS information was not material to the comprehensive assessment called for by the Act. (24) We affirm the ALJ's reasonable determination that this failure contributed to the resident's drastic weight loss.

Windsor also argued that Resident 14's multiple clinical conditions made compliance impossible. RR at 39, 42-43. Windsor pointed out that the resident was admitted with cachexia (which it defined as a chronic condition indicating malnutrition), a history of substance abuse and alcoholism, anorexia, blood poisoning, fractured shoulder, calcium and electrolytic deficiencies, depression, urinary tract infection, a gastrointestinal tract infection accompanied by vomiting, and was subsequently diagnosed with gastroesophageal reflux disease and intestinal disorder. RR at 39, citing P. Ex. 10, at 2; Id. at 42-43. As the ALJ said, and we have affirmed above, "the mere existence of clinical conditions that make it difficult to maintain acceptable nutritional status, by itself, is not enough to meet Petitioner's burden of proof." ALJ Decision at 11. We note that, multiple conditions aside, Windsor did not challenge the surveyor's observations that the resident was not assisted with eating. The facility must first more clearly establish that it provided adequate nutrition in a manner reasonably calculated to make the resident likely to ingest or absorb it before the clinical condition exception can apply.

Windsor also argued that it was not slow to react to the resident's weight loss, as the facility dietitian conducted an assessment upon admission and implemented multiple interventions. RR at 40. The resident was admitted on September 22, 1998. P. Ex. 10, at 2. The ALJ noted that the failure to react occurred after the eleven pound weight loss in October, at least a month after the initial assessment occurred. ALJ Decision at 11. The record reflects a series of contacts with the physician during October, but facility records indicate that the resident was not reassessed until November 23. P. Ex. 10, at 4. The ALJ could reasonably conclude that this time span indicated a slow response to the severe weight loss by this resident, who was already well under her ideal body weight upon admission.

Windsor further argued that the ALJ erred by concluding that the facility failed to offer meals or substitutes to the resident on certain days in November. RR at 42-43. The ALJ cited "the facility's own documentation" in support of this finding. ALJ Decision at 11, citing P. Ex. 10, at 6. The majority of days in November show that the resident consumed no more than 50% of meals, which is the lowest point between "fair" and "poor" on the facility's flow chart. P. Ex. 10, at 6. The records also reflect twenty meals in November where no intake is documented at all and multiple instances when meal substitutes should have been offered, but were not. Id.

We cannot agree with Windsor that the ALJ should speculate that meals may have been offered on the days for which there is no documentation of meal consumption. These records provide no evidence from which the ALJ could draw that conclusion. Even if these meals had been offered, there is no indication of the amount consumed and, thus, no indication whether a substitute should have been offered. In short, there is inadequate evidence in the record that this resident received adequate nutrition on the days specified.

The ALJ correctly notes that the resident lost an additional seven pounds between November and December 14, following an 11 pound loss in October. ALJ Decision at 11; P. Ex. 10, at 4 (12/14/98 entry). He could reasonably conclude that notwithstanding the interventions employed, in light of other deficient practices, the facility failed to ensure that the resident maintained adequate parameters of nutrition.

Resident 5

The ALJ described how this then 87 year old resident was admitted on October 2, 1998, with multiple diagnoses and weighing 198 pounds. Windsor's nutritional consultant opined that the resident's pre-admission tube feeding regimen provided inadequate calories and protein. Due to hand tremors and contractures, the resident was also unable to feed herself her own meals. The surveyor observed the resident on three occasions with meals uneaten and not being assisted with feeding. The ALJ found that the resident's "tube feeding regimen did not provide enough calories nor enough protein and was less than what was recommended by Petitioner's dietician." The ALJ further found that the resident's meals taken orally were insufficient to compensate for the nutritional shortfall. He concluded that the facility failed to ensure that the resident received adequate nutrition by tube or mouth and failed to show that the resident's cellulitis and pressure sores made compliance impossible. ALJ Decision at 11-12.

On appeal, Windsor argued that Resident 5 received adequate nutrition through "a combination of tube feedings, pleasure meals and house supplements." RR at 45. Windsor also argued that the resident's pressure sores and cellulitis constituted clinical conditions that made compliance not possible. RR at 45-46.

Contrary to the other residents under FFCL 1, we reverse the ALJ as to Resident 5, as the tube feeding and nutritional supplement records document the maintenance of adequate nutritional status. Resident 5 was admitted on October 2, 1998, weighing 198.5 pounds. P. Ex. 8, at 2. On November 23, she weighed 167 pounds, for a weight loss of approximately 32 pounds (16% of body weight) in approximately a month and a half. Id. at 1. In the initial nutritional assessment for tube feeding, Windsor's consultant dietitian established Resident 5's target weight range as 118-150 pounds. P. Ex. 8, at 2. The dietitian estimated that the resident needed 1800-2250 calories and 108-135 grams of protein daily. Id. at 2, 4. She recommended a tube feeding regimen that would supply 1716 calories and 78 grams of protein. Id. at 2.

The facility began Resident 5's tube feeding with Ultracal at a rate of 45 ccs, changed on October 14 to Isosource HN at an increased rate of 65 ccs. P. Ex. 8, at 7, 9. On October 25, Windsor changed the tube feeding regimen again to Isosource HN 300 cc bolus, (25) at meals and bedtime. Id. at 7, 8. From November 1 through November 21, the resident is documented as having consumed the nutritional supplement NutraShake approximately three times daily. Id. at 8. Windsor witness Pam Franks presented unrebutted testimony that the NutraShakes provided 900 calories and 24 grams of protein daily. Tr. at 418.

A November 2 nutrition services progress note states that the resident then weighed 172 pounds (a 27 pound drop in one month). P. Ex. 8, at 4. The note also stated that the resident received 1440 calories and 64 grams of protein through the Isosource HN bolus, in addition to food taken orally through a soft diet and house supplements three times daily. Id. The dietitian noted that the resident was at 115% of her target weight range, and that the tube feeding, diet, and supplements "should provide adequate [calories] to keep [weight] stable. Continue current plan for now." Id. The resident subsequently lost five pounds over the next three weeks.

Based on the above evidence, we conclude that the ALJ's finding of noncompliance as to Resident 5 is not supported by substantial evidence in the record as a whole. Carehouse requires that the facility demonstrate that it provided the resident with nutrition adequate for the resident's needs. It is uncontroverted that throughout November, one month after admission, the resident received 1440 calories daily from tube feeding and 900 calories daily from house supplements, for a total of 2340 calories. The resident also received a total of 88 grams of protein daily, comprised of 64 grams through tube feeding and 24 grams through house supplements. The caloric intake exceeds the recommendation of Windsor's dietitian, while the protein intake is a little less than recommended. There is uncontroverted testimony that the resident also received additional caloric intake through her partial consumption of the soft diet three times daily. Tr. at 418. (There was no indication of the amount of protein received through meals taken orally). The resident lost 2.9% of her total body weight from November 2-23, which does not meet the criteria for a significant or severe weight loss under the SOM Guidelines. At all times prior to the survey, the resident remained above her target weight range.

We thus reverse the ALJ's finding that Windsor failed to maintain substantial compliance as to Resident 5.

Resident 15

The ALJ described how this then 93 year old resident's weight dropped from 107 pounds on January 13, 1998, to 86 pounds on October 25, 1998, for a 21 pound weight loss over nine months (approximately 20% of total body weight). P. Ex. 11, at 1. The ALJ concluded that despite several periods of severe weight loss in this time (including a 10.4% weight loss in the three months from March through May), the facility failed to "implement measures" in response until September 9, when it began monitoring the resident's weight on a weekly basis. The resident consumed virtually all nutritional supplements offered in November 1998. The ALJ rejected Windsor's arguments that it timely intervened and that clinical conditions of refusal to eat and pressure sores made compliance impossible. ALJ Decision at 12-13.

On appeal, Windsor asserted that part of the resident's weight loss was caused by her refusal to eat. Windsor further maintained that it first responded to the weight loss in May, by modifying the plan of care to include snacks three times daily, and then again in September, by requiring weekly weights and adding super cereal for breakfast. Windsor finally argued that it intervened yet again in November, by ordering supplements three times daily, in response to a seven pound weight loss in October caused by a pressure sore. RR at 48-49; Reply at 16-17.

The annual nutritional assessment, dated August 17, 1998, states an ideal weight range of 92-119 pounds. P. Ex. 11, at 11. The resident's care plan, with print date of September 18, 1997, contains handwritten entries of "no weight loss" dated December 11, 1997, and March 5, 1998. P. Ex. 11, at 9. A handwritten entry two months later, on May 28, 1998, lists a seven pound weight loss "in [the] past quarter" and accompanies a handwritten entry for snacks three times daily. Id. at 8. Contrary to the ALJ, we conclude that the steps in May were interventions for the severe weight loss from January through April.

However, the only evidence of daily snacks used as an intervention is the handwritten entry on the plan of care. Windsor offered no facility records indicating that snacks were actually offered or consumed. A plan of care, dated August 20, 1998, reflects an 8% weight loss in the preceding three months. P. Ex. 11, at 6. The resident's weight on August 27 (90 pounds) marked the first time the resident fell below the range of ideal body weight. On September 9, the physician ordered weekly weight monitoring and super cereal for breakfast. P. Ex. 11, at 3, 13. Windsor submitted no records to support that Resident 15 consumed the super cereal or that weekly weights were obtained.

The record also raises substantial questions about the effectiveness of self-feeding. The physician noted in August 1997 and February 1998 that the resident was alone and feeding herself. P. Ex. 11, at 2. In April 1998, the physician also noted that the resident "doesn't eat well [and] is loosing [sic] weight." Id. The August care plan states that the resident is at risk because of her "poor appetite" and the fact that she is a "picky eater." Id. at 6. The care plan further notes that she "feeds self with tray set-up" and that she "leaves 25% or more food uneaten at meals." Id. The goal is that she "will continue to be independent in self-feeding . . . ." Id. (The care plan also calls for the staff to encourage the resident to consume 50-75% of one meal a day "and assist with feeding.") Id.

The dietary notes, however, conflict with the nursing notes. The August 17, 1998 annual nutritional assessment assesses the resident's feeding ability as "fed per staff." P. Ex. 11, at 11. Similarly, the November 2, entry on the quarterly nutritional assessment indicates that she is "fed per staff." Id. at 10. (26) Handwritten entries dated October 18 and November 12, 1998, on the care plan indicate that the resident refused assistance with meals or to go to the dining room. Id. at 6.

We infer from this ambiguous evidence that the resident fed herself by hand, albeit poorly, during the eleven month period prior to the order for nutritional supplements. (27) The resident lost 21 pounds during this period, relying upon food taken orally. We agree with the ALJ that had Windsor offered the house supplements prior to November, "such a severe weight loss could have been avoided." ALJ Decision at 13.

We also reject Windsor's argument that the weight loss was attributable to a clinical condition. Reply at 27, citing CMS Ex. 11, at 13. First, Windsor cited the record concerning Resident 5, not Resident 15. (28) Second, the August 17, 1998, annual nutritional assessment for Resident 15 contains no check mark in the box for pressure sores, but does contain one for "reddened areas" of the skin. P. Ex. 11, at 11. A September 7 physician order refers to a rash on the back and buttocks, with treatment to include Lotrimin. Id. at 3. A November 2 entry on a quarterly nutritional assessment references a "Stage II sacrum rash on buttocks." P. Ex. 11, at 10. Windsor pointed to no other evidence concerning a pressure sore or related conditions.

As we have held, "if a facility can demonstrate that it provided adequate nutrition such that a resident's weight loss is not a parameter of nutrition, then it has demonstrated substantial compliance with the regulation and is not required to show that this narrow [clinical condition] exception applies." Carehouse at 22. If a facility fails to demonstrate that it provided adequate nutrition, then it is the facility's burden to "demonstrate that the resident's clinical condition made such a goal impossible . . . ." Id. We conclude that Windsor, first, did not demonstrate that it supplied the resident with adequate nutrition and, second, did not demonstrate that the resident's pressure sores made maintenance of adequate nutrition impossible.

Resident 2

The ALJ described how this then 83 year old resident's weight dropped from 135 pounds on February 4, 1998, to 109 pounds on November 28, 1998, for a 26 pound weight loss over nine months (approximately 20% of total body weight). The facility failed to increase tube feeding, despite the dietitian's recommendations. The ALJ concluded that physician concerns about regurgitation and aspiration risks of increased tube feeding were not significant, noting that prior nurse notes had not mentioned problems with tube feeding. ALJ Decision at 13.

On appeal, Windsor again asserted the physician's concerns regarding regurgitation and aspiration. Windsor further argued that the severe weight loss in October resulted from a pressure sore, which made compliance impossible. RR at 49-53; Reply at 17-18.

On October 26, the quarterly nutritional assessment reflects that the resident received Isosource 1.5 tube feeding at 40 cc/hour. CMS Ex. 37, at 9. On November 2, the facility's dietary staff recommended increasing the tube feeding rate to 50 cc/hour. Id. at 10. On November 11, the physician signed progress notes continuing Isosource HN at 40 cc/hour. Id. at 4. On November 18, when the surveyor asked why the tube feeding had not been increased, the physician explained that he was reluctant to do so because of the resident's regurgitation problem. CMS Ex. 30, at 7. He indicated that he would do so, however, "on a trial basis." Id. There is no evidence to indicate that the rate was subsequently increased. There is, however, a November 23 entry by the dietary staff noting a steady weight decline since January and again recommending increased tube feeding to Isosource 1.5 at 50 cc/hour. P. Ex. 7, at 13.

The record suggests no problem with tube feeding at a rate of 45 cc but a possible problem at the rate of 60 cc. July 22 nurse notes indicate "continuous tube feeding" with "Osmolite HN . . . @ 45 cc/hr." P. Ex. 7, at 8. On August 5, the physician ordered an increase in tube feeding to 60 cc/hour. Id. at 23. An August 11 assessment shows tube feeding of Osmolite HN at 60 cc/hour. Id. at 11. The entry for "Tolerance of Tube Feeding Regimen (Note nausea, vomiting, high residuals, diarrhea, etc.)" is blank. Id.

An August 19 care plan entry states that the resident is "at risk for aspiration and fluid imbalance r/t use of peg tube" and reflects an undated handwritten entry to change tube feeding from Osmolite HN at 60 cc/hour to Isosource at 40 cc/hour. P. Ex. 7, at 9. A September 9 dietary note shows a change to Isosource HN at 40cc/hour and recommends another change to Isosource 1.5 (with a higher caloric and protein intake) at 40 cc/hour. Id. at 14. A November 2 dietary note recommends an increase of tube feeding rate to 50 cc/hour. Id. A November 23 entry on the nutritional assessment also recommends an increase to 50 cc/hour. Id. at 13.

The record does not reflect that the resident actually experienced regurgitation or aspiration problems during this period. Nursing entries from late July reflect no problems at 45 cc/hour. P. Ex. 7, at 8. The record contains no nurse notes for August or September, but the August 11 tube feeding assessment indicates no problems with tolerating tube feeding. Id. at 11. Nurse notes from October 1-21 also reflect no problems. Id. at 6-7. A July 22 physician's progress note expresses concerns for aspiration not in relation to tube feeding, but food consumption. Id. at 2.

There is no indication that the nursing staff or dietary staff addressed or attempted to reconcile any physician concerns about regurgitation or aspiration with the resident's need for increased caloric and protein intake, as recommended by the dietary staff. There is also no evidence to indicate that the physician had actually been made aware of or considered the recommendations of the dietary staff prior to the surveyor's interview. The documentary record does not reflect problems with tube feeding rates of 45 or 60 cc/hour.

Windsor witness Sherry Pippin, however, testified generally:

[A]t times it would be . . . like she would be over full and she would maybe regurgitate a little bit. . . . I know her tube feeding was adjusted a couple of times due to the fact that she would, you know, get some lung congestion. And to avoid her from aspirating, we would reduce her tube feeding for awhile.

Tr. at 449. However, there is nothing in this testimony that links any specific decrease in tube feeding rates in the record to aspiration concerns. Windsor pointed to no documentary evidence that the resident actually experienced regurgitation or aspiration at any rate. There is no evidence to support that the reduction from 60 to 40 cc/hour, for example, was in response to resident intolerance, rather than a desire to change tube feeding products for unrelated reasons (such as a different mix or concentration of caloric, protein, and fluid ingredients). The ALJ reasonably noted that the physician's agreement to try a 50cc/hour rate reflects that his concerns did not rule out the dietitian's recommendations.

We also reject Windsor's contention that increased tube feeding "resulted in nausea, vomiting, and diarrhea." RR at 52, citing P. Ex. 7, at 6-7; Tr. at 257. First, these conditions are distinct from the regurgitation and aspiration concerns which form the basis of Windsor's challenge. Second, this assertion arises from a cross-examination question, indicating that the documentation of no nausea, vomiting, or diarrhea could "be construed to indicate that there was a problem with nausea, vomiting, and diarrhea" in the past. Tr. at 257-58. Windsor's counsel explained that since "nurses generally document by exception," the fact that the absence of these conditions was noted indicated that the resident had once suffered them. Id.

This argument is baseless. Windsor submitted no documents which suggest that the resident at any time, and at any tube feeding rate, suffered nausea, vomiting, or diarrhea, although Windsor would be in the best position to have obtained such documentation from its records. (At another point, Windsor argued the contrary position, that the same notes showed that these conditions did not exist. RR at 51). The facility's nutritional assessment provides a blank where providers are to document resident "nausea, vomiting, high residuals, or diarrhea, etc." to show tube feeding tolerance. P. Ex. 7, at 11. Surveyor Younger testified that documenting the absence of these conditions in nurse notes reflects that these conditions have not happened, "not that it could happen or that it has happened." Tr. at 258. We agree.

The record also raises questions about how much nutrition the resident actually received. Surveyor Younger observed the resident's tube feeding disconnected at 10:15 AM on November 18, when the resident was up in her wheelchair, with wet towels on the floor beneath the wheelchair. Three hours later, the tube feeding was reconnected, although the spilled tube feeding remained on the floor. CMS Ex. 37, at 3. Surveyor Dunn also recorded a similar observation at 10:03 AM, that the tube had become disconnected and was reconnected by the nurse staff member (CNT). CMS Ex. 30, at 36. Thirty minutes later, Surveyor Dunn wrote that the "tube had come lose [sic] again and was spilling out on to Resident's shirt." Id.

Windsor also argued that the resident's "development of a pressure sore in September and October 1998" may have made compliance impossible. RR at 52. The dietitian recommended on November 2 to increase tube feeding to "meet est. needs for wound healing." P. Ex. 7, at 14. The failure to increase the nutritional intake per this recommendation is puzzling, given the documentation of a Stage III skin breakdown one week before. Id. at 12. The record is also silent on any actual increase in the rate of tube feeding following the physician's November 18 agreement to do so on a trial basis. Instead, on November 23, the dietitian yet again recommended an increase to 50 cc/hour. We thus conclude that Windsor did not use this reasonable intervention of increased rate to maintain acceptable parameters of nutrition.

Finally, we note Windsor's reference to a July 22 nurse note indicating that the sacral stage III sore had healed. RR at 52, citing P. Ex. 7, at 8. Windsor then related the resident's August weight gain to the healing of that sore, arguing that the fact that the resident gained weight after the sore healed showed that existence of the sore caused the weight loss. Id. As Windsor pointed out, the nine pound weight gain to 124 pounds is dated August 18. Id. at 52, n.44; P. Ex. 7, at 1. On August 26, however, the resident's weight is recorded as 119.5 (a four and a half pound drop in one week). Id. A September 9 dietitian note reflects the presence of a Stage III decubitus ulcer. Id. at 14. On September 30, the resident's weight is recorded as 118, a one and a half pound loss in a month. Id. at 1. We are thus unable to conclude that this record demonstrates a causal relationship between the resident's pressure sores and weight loss, as Windsor argued.

We therefore affirm the ALJ's determination as supported by substantial evidence. ALJ Decision at 13. Accordingly, we need not consider Windsor's argument that the clinical condition exception applies. Even if such a narrow exception applied here (and it does not), we are unable to agree that the record demonstrates that the resident's clinical conditions made compliance impossible.

Other Residents

The ALJ also discussed weight loss associated with Residents 7, 16, 17, 26, 27, 28, 29, 30, and 31. ALJ Decision at 13-14. These residents are cited in the November CMS 2567. P. Ex. 1, at 9-11. The ALJ cited documentary evidence as to each of these residents, as follows.

Resident 7 CMS Ex. 27, at 7 (CMS 2567)

Resident 16 CMS Ex. 27, at 8 (CMS 2567)

CMS Ex. 51, at 7, 11 (RRW)

Resident 17 CMS Ex. 27, at 8, 52 (CMS 2567)

P. Ex. 13, at 3 (facility records)

Resident 26 CMS Ex. 27, at 9 (CMS 2567)

Resident 27 CMS Ex. 27, at 9 (CMS 2567)

Resident 28 CMS Ex. 27, at 9 (CMS 2567)

Resident 29 CMS Ex. 27, at 9 (CMS 2567)

Resident 30 CMS Ex. 27, at 9 (CMS 2567)

Resident 31 CMS Ex. 27, at 9 (CMS 2567)

ALJ Decision at 13-14. The ALJ did not cite to any testimonial evidence concerning these residents.

The ALJ appears to have addressed the evidentiary basis for this deficiency in his background discussion. There, he noted:

Petitioner argues that there was no testimony at hearing [sic] to corroborate portions of CMS's Statement of Deficiencies (2567) and some of CMS's other exhibits. Petitioner argues that the exhibits in question constituted impermissible hearsay and that I should not admit them into evidence. Petitioner's position is that as to those residents and deficiencies for which no testimony was provided at hearing [sic], CMS has failed to present enough evidence to establish a prima facie case and that under Hillman, it is entitled to a decision in its favor concerning those residents and deficiencies. . . .

ALJ Decision at 3.

Windsor argued on appeal that it had not had been provided the opportunity to brief the deficiencies for these residents, that "[n]o evidence was presented on these 'other residents' by CMS at the hearing," and that the evidence relied upon by the ALJ did not support the deficiency finding. RR at 53, 77; Reply at 1-3. Windsor also argued that evidence concerning Residents 16 and 17 did not support the deficiency finding. Id.

i. The CMS findings for Residents 7, 26, 27, 28, 29, 30, and 31 are supported by substantial evidence in the record as a whole.

First, we find no unfair surprise to Windsor in the ALJ's reliance upon these residents to support this deficiency. Contrary to Windsor's assertion, the parties briefed in extensive post-hearing filings whether CMS brought forward sufficient evidence. CMS Post-Hearing Brief (PHB) at 26-27; Windsor PHB at 5-12, 39-41; CMS's Post-Hearing Reply Brief (PHRB) at 4-13; Windsor PHRB at 8-12, 25-26.

Second, we reject Windsor's argument that CMS submitted "no evidence" to support the findings in the CMS 2567 for the cited residents. It is undisputed that CMS presented no testimonial evidence on these residents. However, the CMS 2567 reflects that this deficiency affected 15 of 120 residents. P. Ex. 1, at 7. The citations for these residents state that the deficiency was based upon "record review." Id. at 11. CMS submitted into evidence Surveyor Ray's notes reflecting weight loss associated with 15 named residents. CMS Ex. 30, at 12. (29) Those weight losses correlate with the weight losses attributed to the residents cited in this deficiency. (30)

The ALJ correctly noted that CMS may make its case through documentary, rather than testimonial, evidence. The CMS 2567 clearly put Windsor on notice as to the identities of these residents. CMS submitted documentary evidence supporting the weight losses reflected in the CMS 2567, and Windsor posed no objection to that exhibit. Windsor itself submitted medical records for each of these residents as exhibits. See P. Exs. 9 and 14-19 for Residents 7 and 26-31, respectively. The findings of the CMS 2567, as reflected in Ms. Ray's notes, are consistent with weight losses reflected in records submitted by Windsor. It is thus clear that these citations were not assertions without evidentiary basis. Meadow Wood at 7.

We therefore affirm the ALJ's findings concerning Residents 7 and 26-31 as supported by substantial evidence on the record as a whole. Given this conclusion, we need not address the parties' arguments concerning hearsay and the CMS 2567 as evidentiary support establishing noncompliance.

ii. The CMS findings for Residents 16 and 17 are supported by substantial evidence.

The ALJ determined that Resident 16 lost 7.8% of her body weight during 1998, and that she failed to receive assistance with feeding as required by her care plan. ALJ Decision at 13-14, citing CMS Ex. 27, at 8; CMS Ex. 51, at 7, 11. He also determined that Resident 17 lost 20.5% of her weight during 1998 and that Windsor failed to provide timely intervention and to comply with a physician's order for supplements. Id. at 14, citing CMS Ex. 27, at 8; CMS Ex. 52; P. Ex. 13, at 3.

We first reject Windsor's argument that the ALJ erred by determining that CMS established a prima facie case as to Residents 16 and 17. In addition to the weight loss asserted in the CMS 2567, CMS submitted both surveyor notes and additional documentary evidence in support. Failing to provide testimonial evidence in addition to that documentary evidence does not warrant reversal. CMS has offered evidence sufficient to establish some evidentiary basis for these deficiencies, i.e., that they are not simply unsupported assertions.

Resident 16

Windsor argued that this then 95 year old resident sustained only a 7.8% weight loss from January through November, which did not meet CMS's guidelines for significant or severe weight loss over six months. Windsor also argued that the ALJ erred by concluding that Windsor failed to provide feeding assistance consistent with the care plan, as the resident's care plan only required verbal cuing for meals. Windsor finally argued that its due process rights were violated, as the surveyor making the observation was not present at the hearing and subject to cross-examination. RR at 53-54; Reply at 28-29.

First, the monthly weight record reflects a nine pound weight loss (from 102 pounds to 93 pounds) over eight months, for approximately 9% of the resident's total body weight. P. Ex. 12, at 1. The resident's nutritional assessment reflects an ideal body weight of 114-146 pounds and current weight of 95 pounds in 1998. Id. at 2. The resident's weight at the beginning of 1998 was over ten pounds below the lowest end of the range for her ideal body weight. We conclude that the consistent weight loss over the next eight months was both unplanned and undesired and reflected a failure to provide adequate nutrition. (31)

We also disagree that the ALJ's conclusion that Windsor failed to provide feeding assistance is not supported by substantial evidence. The facility completed a "Nutritional Status" Resident Assessment Protocol (RAP) on June 29, 1998. CMS Ex. 51, at 8-9. The RAP states that the resident's dementia placed her at risk for malnutrition, that the resident was not able to understand the importance of eating, and that these cognitive factors affected the resident's nutritional status. Id. at 8. The RAP points out that the resident had a reduced ability to feed herself, required assistance with feeding, and left 25% or more of her meals uneaten. Id. at 9. The RAP reflects that her decision making ability affected her ability to communicate and placed her at risk for malnutrition. Id. The RAP calls for care planning, due to the resident's dementia, need for assistance with activities of daily living (ADLs), and "impaired decision making abilities." Id.

The care plan cited by Windsor, dated June 30, 1998, states that the resident "requires verbal cues while eating." CMS Ex. 51, at 6, 7. However, the care plan also states that the resident is "able to feed self with spoon & guidance to hand to mouth." Id. (emphasis supplied). The care plan further provides that nursing staff would "assist with putting food on spoon and directing toward mouth and enc[ourage] resident to feed self." Id. at 7. We thus conclude that the care plan called for staff assistance with meals beyond verbal cues.

Surveyor Leonard Robinson completed the Resident Review Worksheet (RRW) for Resident 16. He documented his observation that during breakfast on November 17, the resident fed herself with "little effect." A CNT began to feed her, then she refused to eat further. The surveyor noted that Resident 16 had to be fed by the CNT. The nurse aide verbally cued the resident to eat, and her tray was removed when she did not. CMS Ex. 51, at 1, 11.

The surveyor's notes constitute admissible hearsay evidence, to be accorded such weight as consistent with other indicia of reliability. The fact that the surveyor was not present for cross-examination does not, standing alone, constitute reversible error, particularly since Windsor had the opportunity to subpoena the surveyor and did not. See Perales and Richardson. We conclude, based upon the documentary evidence (RAP and care plan) that, contrary to Windsor's argument, the facility was required to provide this cognitively impaired resident with more than "verbal cuing." As Windsor offered no rebuttal evidence to outweigh the surveyor's notes, we conclude that Windsor's due process argument fails. We affirm the ALJ's conclusions as supported by substantial evidence.

Resident 17

Windsor argued that this then 90 year old resident's weight loss from February through April 1998 was attributable to pressure sores that "developed during this same period of time" and that the resident's weight was stable for the next six months. RR at 54-55, citing CMS Ex. 12, at 4; CMS Ex. 52, at 3, 7. Windsor also argued that it responded immediately to the April weight loss by offering nutritional supplements and snacks three times daily in May. Id. at 55, citing P. Ex. 13, at 6.

The facility's weight record reflects a 20 pound weight loss (from 107 to 87 pounds) between January and April, 1998, with a 12 pound drop in the month from March to April. (32) P. Ex. 13, at 3. The total loss reflects an 18.7% loss of total body weight in three months. The facility's nutritional assessment reflects an ideal body weight of between 118-150 pounds (id. at 5). Thus, in April, the resident was 31 pounds below her minimum acceptable weight.

An initial assessment dated January 8, 1998, reflects that the resident required "max verbal cueing [with] eating." CMS Ex. 52, at 14. This assessment also reflects Stage II pressure sores on the right foot, and Stage I pressure sores on the left foot with "signs of healing noted." Id. The initial nutritional assessment, which is undated, denotes the resident's swallowing ability, ability to communicate verbally, and comprehension all as "impaired," and summarized the "feeding ability assessment" as "fed by staff." P. Ex. 13, at 5.

The January 8, 1998, care plan contains handwritten entries showing a Stage III sore on the right foot and ankle healed as of February 11, while a Stage II sore on the right trochanter was healed as of March 26. CMS Ex. 52, at 7. A February 17 nurse note states that right foot wounds were healed as of February 7. P. Ex. 13, at 15. On February 20, the weekly skin assessment reflected "no open or redden [sic] areas noted . . . ." Id. at 16. A February 27 skin assessment also showed "no reddened or open areas noted." Id. at 17.

This care plan also contains undated handwritten entries that reflect various interventions: feeding by staff, meal substitutes, high protein shakes three times daily, super cereal at breakfast, and the offer of house supplements twice daily. Id. Physician's orders dated September 9 call for weekly weights and super cereal; orders dated October 14 call for house supplements and feeding the resident. Id. at 4. A medication flow sheet reflects that house supplements ordered on October 14 were provided through October 17, then discontinued. Id. at 5. There is no physician's order in the record discontinuing the supplements.

A resident care flow record, with a "date beginning" that is partly obliterated, reflects that between the 22nd and 31st of the illegible month (the resident was admitted on December 22, 1997), the resident consumed 10% of her breakfast and noon meals most of the time, with some instances of 25% and 50% consumption, and very few instances of 90% and 100% consumption of the evening meal. Substitutes were all marked "refused." P. Ex. 13, at 9. Nurse notes between January 30 and February 12 sometimes document meal consumption and reflect 25-75% consumption of dinner and a one time consumption of an Ensure supplement. P. Ex. 13, at 14. A February 1 entry reflects that the resident required maximum assistance with supper secondary to confusion and poor vision. Id. A February 11 entry reflects that the resident consumed 10% of her dinner meal, while on February 12, the resident could feed herself "some" with encouragement. Id. at 15. On February 13, the resident's appetite is described as "poor." Id. Remaining entries for February often do not mention meal consumption or, when they do, reflect poor intake. The notes also continue to reflect the resident's difficulty swallowing. Id. at 16 (February 19, 1998 entry).

While notes by both the nutrition and nurse staffs indicate that Ensure nutritional supplements were given (P. Ex. 13, at 6, 14), Windsor pointed to no evidence to demonstrate on a consistent basis when these supplements were offered or the amount consumed. Contrary to Windsor's argument, the record does not reflect that snacks were offered or consumed. RR at 55; P. Ex. 13, at 6.

Based on the record as a whole, we affirm the ALJ's findings with respect to this resident. First, the care plan and nurse notes reflect that two Stage III pressure sores were healed by February 11. The severe weight loss is documented as occurring between March 11 - April 12. While the record reflects that a Stage II sore on the trochanter did not heal until March 26, the ALJ reasonably attributed the severe weight loss to the lack of interventions, rather than to that pressure sore.

We also affirm the ALJ's finding that Windsor failed to intervene before September. While Windsor argued that it responded to the April weight loss by offering Ensure supplements and snacks three times a day in May, nurse notes indicate that the resident occasionally consumed Ensure as early as February 4. P. Ex. 13, at 14. Windsor pointed to no evidence that Resident 17 was offered or consumed snacks. The records that Windsor did submit into evidence are replete with intermittent documentation of the resident's poor meal consumption between December 1997 through February 1998. They also reflect that, at times, the resident fed herself, despite swallowing difficulties and cognitive impairment. In conjunction with the lack of consistent documentation of supplements or snacks, the ALJ reasonably concluded that Windsor did not provide adequate nutrition to Resident 17 during this period.

We also reject Windsor's argument concerning a six-month look back limitation period, for reasons previously explained. However, even at a stabilized weight of approximately 87 pounds, this resident was still at least 31 pounds below the minimum ideal body weight established by Windsor's own nutritional consultant. We cannot agree that allowing a resident to drop to and rest at a weight so severely beneath an acceptable range, as defined by the facility's own documents, is consistent with the regulatory requirement to maintain an adequate nutritional state.

Accordingly, we affirm FFCL 1.

FFCL 2. Petitioner was not in substantial compliance with the regulation concerning personal privacy during the November 18, 1998 survey. 42 C.F.R. § 483.10(e).

A facility's obligations regarding the resident's right to privacy are set forth in 42 C.F.R. § 483.10(e), which states:

The resident has a right to a dignified existence, self-determination, and communications with and access to persons and services inside and outside the facility. A facility must protect and promote the rights of each resident, including each of the following rights:

* * * * *

(e) Privacy and confidentiality. The resident has the right to personal privacy and confidentiality of his or her personal and clinical records. (1) Personal privacy includes accommodations, medical treatment, [and] personal care . . . but this does not require the facility to provide a private room for each resident. . . .

Id. TDH cited this deficiency under F-Tag 164, at Level E. P. Ex. 1, at 1.

The ALJ found that the facility failed to draw the privacy curtain to shield an unidentified semi-nude resident from view during a bath in a communal bathroom. The ALJ also found that Resident 13 (a different individual) was exposed to public view during personal care when the privacy curtain was not drawn. The ALJ concluded that 18 rooms contained privacy curtains that were too short to surround the resident's beds or were missing, torn, or otherwise inadequate. ALJ Decision at 15.

Windsor contended that the resident in the communal bathroom received adequate privacy as only one staff member was in the room bathing her. Windsor also maintained that there was no privacy curtain in the communal bathroom to pull and that the bathroom was set up so that only staff could enter. RR at 56-57.

We reject these arguments in light of Surveyor Malone's unrebutted testimony that she first knocked on the door and entered after receiving no response, thereafter seeing the resident nude from the waist up. Tr. at 294. A resident's privacy is violated when individuals not necessary to the provision of resident care (including facility staff) are permitted to be present without the resident's consent. SOM, App. PP, at PP-24. Whether or not the communal bathroom had a privacy curtain is irrelevant to the fact that the staff inside the bathroom did not question Ms. Malone's entry after knocking.

We also affirm the ALJ's findings with respect to Resident 13. Windsor argued that the Resident Room Review (RRW) completed by Surveyor Younger shows conflicting information concerning privacy curtains. On the first page, the RRW asks, among other things, whether "adequate accommodations are made for resident privacy, including bed curtains." CMS Ex. 48, at 1. The surveyor initialed the line beside the statement "[t]here are no identified concerns for these requirements." Id. Below that line, surveyors are advised to "[d]ocument concerns and follow-up on Surveyor Notes sheet page 4." Id. (emphasis supplied). On page four, the surveyor documents that at 11:10 AM on November 16, she observed "care being done by tech. Buttocks exposed. Privacy curtain was not pulled & won't pull far enough to cover foot of bed." Id. at 4. A surveyor could reasonably document on page one of the RRW that the room had bed curtains, while later noting a problem with the quality or functionality of those curtains. Those follow-up concerns would have been documented on page four (as occurred here), per the instructions on page one.

We also affirm the ALJ's findings with respect to some, but not all, of the 18 examples for inadequate privacy curtains. CMS presented evidence documenting surveyor observations of inadequate curtains in 12 rooms: 7, 8, 10, 11, 13, 14, 16, 17, 19, 20, 41, and 54. CMS Ex. 30, at 18 (Room 41), 22 (Room 54), and 35 (Rooms 7, 8, 10, 11, 13, 14, 16, 17, 19, 20). CMS pointed to no testimonial or documentary evidence to support the examples cited for Rooms 23, 29, 32, 34, 39, and 43. As the surveyor's observations of deficient accommodations concerning 12 rooms are unrebutted, we affirm the ALJ's conclusions regarding these examples of the deficiency. Ivy Woods Health Care and Rehabilitation Center, DAB No. 1933, at 8 (2004)(undisputed findings sufficient to sustain deficiency). We thus need not reach the question of whether the CMS 2567 constitutes substantial evidence to support the deficiency as to the remaining six rooms.

Finally, Windsor claimed that although this deficiency "was based on only three (3) findings, [CMS] assigned a pattern of scope [sic] to the deficiency. Such a determination is clearly erroneous." RR at 56, n.45. This contention is singularly without merit. Windsor's argument ignored that the evidence supports that at least a dozen rooms contained inadequate privacy curtains, in addition to the exposed residents discussed above.

Further, "pattern" is a level of scope used to categorize facility noncompliance. See SOM App. P, § V.C. (33) A provider may not appeal a CMS determination on the level of noncompliance (scope and severity) unless a successful challenge on this issue would affect either the range of CMP amounts that CMS could collect or a finding of approval of a nurse aide training program. 42 C.F.R. § 498.3(b)(14); see also 42 C.F.R. § 498.3(d)(10)(ii). Windsor did not argue that either of these situations applied here. Nor did Windsor argue that the factual bases for the deficiency were materially different than those found by CMS. Lake City Extended Care Center, DAB No. 1658, at 13-14, n.16 (1998)("We see nothing in the regulations that precludes the ALJ from making a new finding as to the scope of a deficiency where the ALJ findings are different from the survey findings.")

Accordingly, we affirm FFCL 2.

FFCL 3. Petitioner was not in substantial compliance with the regulation concerning housekeeping during the November 18, 1998 survey. 42 C.F.R. § 483.15(h)(1).

Windsor did not appeal the deficiency cited under FFCL 3 (F-Tag 252, Level E), which we therefore leave undisturbed. P. Ex. 1, at 3; ALJ Decision at 16.

FFCL 4. Petitioner was not in substantial compliance with the regulation concerning accident hazards during the November 18, 1998 survey. 42 C.F.R. § 483.25(h)(1).

Windsor did not appeal the deficiency cited under FFCL 4 (F-Tag 323, Level D), which we therefore leave undisturbed. P. Ex. 1, at 6; ALJ Decision at 16-17.

FFCL 5. Petitioner was not in substantial compliance with the regulation concerning sufficient staffing during the November 18, 1998 survey. 42 C.F.R. § 483.30.

A facility's obligations regarding nursing services (sufficient staff) are set forth in 42 C.F.R. § 483.30, which states, in relevant part:

The facility must have sufficient nursing staff to provide nursing and related services to attain or maintain the highest practicable physical, mental, and psychosocial well-being of each resident, as determined by resident assessment and individual plans of care. (a) Sufficient Staffing. (1) The facility must provide services by sufficient numbers of each of the following types of personnel on a 24-hour basis to provide nursing care to all residents in accordance with resident care plans: (i) [L]icensed nurses; and (ii) Other nursing personnel. (2) [T]he facility must designate a licensed nurse to serve as a charge nurse on each tour of duty.

Id. TDH cited this deficiency under F-Tag 353, at Level F. P. Ex. 1, at 13. The CMS 2567 states that the facility failed to provide sufficient staff to meet resident needs. Id.

The ALJ found that the evidence clearly demonstrated that Windsor was inadequately staffed to provide required care. ALJ Decision at 17. The ALJ described how inadequate staffing affected resident care, including two instances where 15-20 and 10 residents, respectively, were assisted with feeding by only one nurse aide. He also discussed how Residents 5, 14, 1, and 15 required feeding assistance, but were observed without assistance during meals. Statements from family members and facility staff also supported a finding of inadequate staffing. Windsor's staff assignment book "revealed evidence of insufficient staffing" on at least 10 occasions during the month before the survey. ALJ Decision at 17-18.

On appeal, Windsor argued that Resident 5 relied on tube feeding "for a majority of his feeding" and that the records for Residents 14, 1, and 15 document that they "fed self with assistance." Windsor also argued, without citation, that the failure to identify the multiple residents being assisted by one aide precluded Windsor from demonstrating that "the assistance required was nothing more than encouragement or cueing." Windsor further contended that the family member who testified about inadequate staffing was not competent to testify about nurse staffing issues and had not expressed her concerns to facility administration or corporate owners. Windsor also maintained that the staff member who had advised the surveyors about staffing inadequacies meant occasional problems from sick leave. Windsor continued by arguing that the testimony of the surveyor who reviewed the facility assignment book was confused and inconsistent with her notes. Windsor finally asserted that its compliance with state staffing requirements rebutted the deficiency. RR at 60-61.

First, Windsor's argument that the failure to identify the residents being assisted by one aide "precludes the Facility from having the opportunity to provide any rebuttal" is unpersuasive. RR at 59. The ALJ cited the testimony of Surveyor Ray concerning an observation of one aide feeding between 15-20 residents. ALJ Decision at 17, citing Tr. at 124. Surveyor Ray concluded that "it isn't logical to think that one person could feed 15 to 20 people within a reasonable period of time." Tr. at 124. Windsor's cross-examination reveals no challenge to these statements or request for resident identities. Tr. at 167-98. We thus conclude that the statement is unrebutted and, therefore, affirmed.

Windsor's argument also fails, since the ALJ cited to Surveyor Dunn's observation of one aide feeding ten residents (including Resident 17) on November 17 at 7:38 PM. ALJ Decision at 17, citing CMS Ex. 52, at 21. This provides ample information from which Windsor could determine (from its own records) which residents were fed with Resident 17 at that specific time on that specific date and by whom. Windsor instead provided the unsupported assertion of counsel that "one aide would be more than sufficient for 10 residents." RR at 59. We find this insufficient to reverse the ALJ's findings of inadequate staffing.

Windsor also did not deny that Residents 5, 14, 1, and 15 received no feeding assistance during meals and that records called for at least some staff assistance. RR at 58. For example, a November 2 nursing entry for Resident 5 indicates that the resident ate a soft diet taken orally "with assistance" (which was underscored). CMS Ex. 40, at 4. The ALJ cited to multiple observations where the resident had not eaten any of the meals placed in front of her. Surveyors also wrote that "[r]es. does not appear to be able to eat [without] help. Has bil. hand tremors/contracture [left] hand & arm [with] non-functional use." Id. at 6. We thus find Windsor's argument concerning Resident 5's tube feeding irrelevant, since the lack of staff to assist with oral feeding provided the basis for the inadequate staffing deficiency. We also reviewed evidence cited for Residents 14, 1, and 15, and find that it also supports the ALJ's conclusions.

We also reject Windsor's challenge to the testimony by family member Janet Watts. Ms. Watts testified that both her aunt and mother-in-law had been residents at Windsor. Tr. at 30-31. She provided a letter to surveyors detailing her observations of inadequate care, which she attributed in part to insufficient staff. CMS Ex. 35. The ALJ recounted Ms. Watts' testimony "that she frequently found her mother-in-law covered with old, dried feces because of the inadequate staffing." ALJ Decision at 18, citing Tr. at 46-48, CMS Ex. 35, at 4. Her testimony and letter recount multiple instances of deficient care which a lay observer could reasonably attribute to inadequate staffing. The ALJ acted within his discretion in receiving and weighing testimony from a non-professional with first-hand knowledge of care at Windsor.

The ALJ also cited to Surveyor Malone's testimony that facility nurse Sherry Pippin expressed staffing concerns. ALJ Decision at 18, citing Tr. at 300-302, 455-456; CMS Ex. 30, at 25. This testimony was consistent with Ms. Malone's notes, which also reflect the following interview with a technician:

Reports not enough staff - A lot of times - only 1 tech on 11-7 shift. States they need at least 3 on front & 3 on back hall - They put people on schedule who don't work here - ie "McLemore" - hasn't been here in over a week.

CMS Ex. 30, at 25. Windsor argued that Ms. Pippin "rebutted the allegation" by testifying that staff shortages were occasional and that there had been no "pattern" of insufficient staff. RR at 60, citing Tr. at 455-56, 471-72. However, the ALJ could reasonably deem more credible the surveyor's testimony and supporting documentation than Ms. Pippin's contrary testimony elicited during redirect examination.

We also affirm the ALJ's determination that the facility assignment book evidenced inadequate staffing. ALJ Decision at 18. Windsor did not contest the statement attributed to the Director of Nursing that the day shift should be staffed with 14 nurses' aides. ALJ Decision at 18, citing Tr. at 303-04. Surveyor Malone's notes indicate that the number of CNTs present during the day was less than 14 on every day listed. CMS Ex. 30, at 26. She testified that some days, "there were 10, 11, and 12," and "some days . . . there were 4 and 5." Tr. at 303-04.

Windsor maintained that Surveyor Malone's testimony did not reflect whether she recorded staffing numbers by building or hallway. In fact, Ms. Malone testified that her notes reflect both. Tr. at 332. Even assuming that some numbers reflect staffing by hall rather than building, her notes are not reasonably read as reflecting sufficient staff to meet the building-wide standard on all days listed. In addition to 14 CNTs required for the day shift, Ms. Malone's notes indicate that 9 CNTs are required for the 3-11 shift. The numbers of three and four CNTs documented for the 3-11 shift on November 9-16, even if reflecting the number on the front or back hall, constitute substantial evidence that this standard was not met for the entire building. Similarly, Ms. Malone's notes indicate that five CNTs are required on the 11-7 shift for the whole building; the numbers of one and two during the 7-11 shift on October 9 and 13 constitute substantial evidence of staff shortages on those dates.

We also reject Windsor's argument that the lack of a citation for a care planning deficiency constitutes evidence of the lack of a staffing deficiency. RR at 61. Windsor maintained that the language of the staffing regulation requires staff sufficient to provide services "in accordance with resident care plans." 42 C.F.R. § 483.30(a). Windsor cited to no authority which holds that the citation of the staffing deficiency also requires the citation of a care planning deficiency. CMS may exercise its discretion to determine which participation requirement best accords with factual circumstances. Omni at 31 (failure to cite one deficiency not evidence of compliance with another).

Finally, the ALJ correctly rejected Windsor's argument that compliance with state staffing requirements satisfies the federal staffing regulation. ALJ Decision at 18; RR at 61, citing Tr. at 332-33. The federal staffing regulation contains no safe harbor for compliance with state standards. Moreover, the SOM makes clear that the federal and state standards function independently: "NOTE: Meeting the State mandated staffing ratio, if any, does not preclude a deficiency of insufficient staff if the facility is not providing needed care and services to residents." SOM, App. P, at P-51 (bold in original). The federal focus is on care outcome, not satisfaction of a numerical threshold. We thus affirm the ALJ's determination that compliance, if any, with state staffing requirements does not preclude citation for noncompliance with the federal standard. Westgate Healthcare Center, DAB No. 1821, at 2 (2002) ("[C]ompliance with a minimum resident to staff ratio in state law is irrelevant" to federal compliance).

Accordingly, we affirm FFCL 5.

FFCL 6. Petitioner was not in substantial compliance with the regulation concerning palatable food served at proper temperatures during the November 18, 1998 survey. 42 C.F.R. § 483.35(d).

A facility's obligations regarding dietary services (food) are set forth in 42 C.F.R. § 483.35(d), which states, in relevant part:

The facility must provide each resident with a nourishing, palatable, well-balanced diet that meets the daily nutritional and special dietary needs of each resident.

* * * * *

(d) Food. Each resident receives and the facility provides - (1) Food prepared by methods that conserve nutritive value, flavor, and appearance; (2) Food that is palatable, attractive, and at the proper temperature . . .

Id. TDH cited this deficiency under F-Tag 364, at Level E. P. Ex. 1, at 15. The CMS 2567 states that the facility failed to serve all food at proper temperatures, evidenced by resident complaints and observations of a dysfunctional tray delivery system. Id.

The ALJ found that Windsor residents consistently complained about cold food during survey interviews. Surveyors observed meals left on unheated serving carts for extended periods of time, and food was delivered to the wrong places. Surveyors observed meals served over an hour after the tray left the kitchen, and one resident refused to eat lunch because it was too cold. ALJ Decision at 19.

Windsor argued that the ALJ relied solely upon the CMS 2567 and that residents were not identified in interviews with surveyors. Windsor further argued that Surveyor Ray conceded that food was at the appropriate temperature when tested and that there were "no documents to support . . . that food was served cold." RR at 62; Reply at 37.

These contentions lack merit. The ALJ cited documents that identify the resident by name or number. ALJ Decision at 19; CMS Ex. 30, at 10 (resident name)("cold food comp. cold all the time"); CMS Exs. 31, at 6, 5 (Resident 8)("Food always cold"); Id. at 10, 9 (Resident 9)("Food is cold at all meals, especially breakfast and dinner. Food is allways [sic] late."); Id. at 14, 13 (Resident 10)("Food cold all the time. . . . Food allways [sic] late."); Id. at 23, 21 (Group interview with residents named on first page)(Food always cold, always late, staff "don't do a thing" about resident concerns, "meals never on time"). Similarly, the ALJ cited to Surveyor Ray's documented observation of the November 17 lunch meal and the complaints of two named residents that their food was cold. Id., citing CMS Ex. 30, at 5. Thus, Windsor's argument about unidentified residents, as used here, reflects not ALJ error, but Windsor's failure to review the cited record.

We also reject Windsor's challenge to Surveyor Ray's testimony on grounds that on cross-examination, she "recanted" that food temperature was inadequate and also acknowledged that misplaced trays were "corrected immediately." RR at 62. Ms. Ray testified that "the food temperatures from dietary" that she checked fell within acceptable ranges, but she also testified that surveyors received numerous complaints from residents and family of cold food. Tr. at 122. She clarified how those comments could be reconciled by explaining that trays sat on unheated carts for "an hour or an hour and half [sic] before being served, [so] it has to be cold . . . ." Id. Windsor pointed to nothing which would indicate that Ms. Ray had found that food temperature was within an acceptable range at the time that the resident actually received the food. There is ample evidence that by the time the food got to more than a few residents, it was not warm enough to be palatable. Given this conclusion, we need not consider Windsor's remaining arguments on this point.

Accordingly, we affirm FFCL 6.

FFCL 7. Petitioner was not in substantial compliance with the regulation concerning meal times during the November 18, 1998 survey. 42 C.F.R. § 483.35(f)(1)-(3).

A facility's obligations regarding dietary services (frequency of meals) are set forth in 42 C.F.R. § 483.35(f), which states, in relevant part:

The facility must provide each resident with a nourishing, palatable, well-balanced diet that meets the daily nutritional and special dietary needs of each resident.

* * * * *

(f) Frequency of meals. (1) Each resident receives and the facility provides at least three meals daily, at regular times comparable to normal mealtimes in the community. (2) There must be no more than 14 hours between a substantial evening meal and breakfast the following day . . . . (3) The facility must offer snacks at bedtime daily.

Id. TDH cited this deficiency under F-Tag 368, at Level E. P. Ex. 1, at 16. The CMS 2567 states that meals were not served at times comparable to resident meal times before being admitted to Windsor. Id. at 17.

The ALJ discussed how Windsor failed to dispute resident complaints that meals were served later than residents were used to before admission to Windsor. As examples, he noted breakfast served at 9:40 AM, dinner served at 7:40 PM for two residents (after service began at 6:05 PM) because trays were sent to the dining room instead of the resident rooms, and family complaints of dinner as late as 7:30 PM. Some residents would not eat supplemental feedings at 9:00 PM due to late dinners. ALJ Decision at 20.

Windsor argued that its regular meal service occurred at 8:00 AM, noon, and 6:00 PM. Earlier meal times were, according to Windsor, put back into effect in response to resident complaints. Windsor further argued that the ALJ did not identify residents who "allegedly received late trays," thereby depriving it of the opportunity to rebut the findings. RR at 62-63; Reply at 38.

Windsor's argument ignores that the regulation requires that residents receive daily meals at normal times comparable to the community. The facility's scheduled hours are irrelevant if meals prepared at those times are not received by the residents within a reasonable period thereafter. The ALJ noted the surveyor's observation that some residents were not served within an hour and a half of the purportedly scheduled times due to systemic failures. CMS Ex. 60, at 1; CMS Ex. 30, at 4. Surveyor Ray testified that surveyors saw some residents eating breakfast near 10:00, lunch at 1:30, and dinner "near 8:00 pm." Tr. at 117. These observations are unrebutted. We therefore uphold the ALJ's determinations.

We again reject Windsor's challenge about unidentified residents. The ALJ Decision cites to Surveyor Dunn's notes, where the name of the resident who received a tray at 9:40 AM is (properly) redacted. ALJ Decision at 20, citing CMS Ex. 60, at 1. The ALJ Decision also cites to Surveyor Ray's notes, which do not name two residents identified as receiving dinner trays as late as 7:40 PM. Id., citing CMS Ex. 30, at 4. The ALJ Decision refers to a complaint by a family member of an unidentified resident concerning meals at 7:30 PM. Id., citing CMS Ex. 28, at 1.

The record is replete with pre-hearing disputes concerning the admissibility of CMS's exhibits, which the ALJ discusses in his decision. ALJ Decision at 3-4. CMS Exhibits 60 and 30 were a part of the supplemental exhibits submitted by CMS, the admissibility of which the ALJ addressed in his Pre-Hearing Ruling. Among other grounds, Windsor entered general objections to testimony concerning unidentified residents (Tr. at 104) and hearsay objections "to the introduction of exhibits which purport to document interviews with staff or residents but [do] not identify with any particularity the staff or residents." Petitioner's Objection to Exhibits Proposed By the Health Care Financing Administration, dated June 30, 2000. Windsor did not, however, specifically dispute this deficiency on grounds that the residents were not identified.

In any event, the examples cited by the ALJ are also cited in the CMS 2567. P. Ex. 1, at 18. The CMS 2567 identifies Resident 7 as the resident who did not receive her tray until 9:40 AM. Id.; CMS Ex. 60, at 1 (Dunn notes). The CMS 2567 also references two residents receiving dinner trays at 7:40 PM (CMS Ex. 30, at 4), but Windsor's cross-examination of Surveyor Ray did not request the identities of these two residents. Tr. at 167-98, 212-214. Finally, the complaint by the family member concerning late dinner identifies the name and room number of the resident. CMS Ex. 28, at 1.

We conclude that Windsor had ample notice in the CMS 2567, or in CMS Exhibit 28, of either the identity or identifying circumstances of residents referenced in the ALJ Decision. Windsor had opportunity before and during the hearing to request the identities of the two unidentified residents and did not. Windsor's assertions as to the two unidentified residents are actually a challenge to the credibility of Surveyor Ray's documented observations. We have previously affirmed the ALJ's credibility determination as to Surveyor Ray, and Windsor has fallen short of offering a compelling reason to discount it here.

Accordingly, we affirm FFCL 7.

FFCL 8. Petitioner was not in substantial compliance with the regulation concerning pharmacy services during the November 18, 1998 survey. 42 C.F.R. § 483.60(e).

Windsor did not appeal the deficiency cited under FFCL 8 (F-Tag 432, Level D), which we therefore leave undisturbed. P. Ex. 1, at 19; ALJ Decision at 20-21.

FFCL 9. Petitioner was not in substantial compliance with the regulation concerning the physical environment during the November 18, 1998 survey. 42 C.F.R. § 483.70(f).

A facility's obligations regarding physical environment (resident call system) are set forth in 42 C.F.R. § 483.70(f), which states, in relevant part:

The facility must be designed, constructed, equipped, and maintained to protect the health and safety of residents, personnel and the public.

* * * * *

(f) Resident call system. The nurse's station must be equipped to receive resident calls through a communication system from - (1) Resident rooms; and (2) Toilet and bathing facilities.

Id. TDH cited this deficiency under F-Tag 463, at Level D. P. Ex. 1, at 21. The CMS 2567 states that the facility failed to provide call light systems in all toilets accessible to residents. Id.

The ALJ described how Windsor did not have a call system in a lobby restroom available to residents. The ALJ noted that Windsor presented no evidence in rebuttal. ALJ Decision at 21.

In the summary overview to its Request for Review, Windsor argued that FFCL 9 was not supported by substantial evidence. RR at 26. We are unable to find any other argument in its pleadings to explicate or support this contention. Our Guidelines require that Windsor provide the Board with the legal and factual bases for challenging a deficiency. Batavia II at 57, citing Guidelines. (34) "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.'" Id., citing Wisteria Care Center, DAB No. 1892, at 10 (2003) and Guidelines. The Board "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, Windsor's unsupported contention is insufficient to raise an issue for appellate review. Id.

Accordingly, we affirm FFCL 9.

B. The December 10, 1998 Revisit Survey.

FFCL 10. Petitioner was not in substantial compliance with the regulation concerning housekeeping during the December 9, 1998 revisit survey. 42 C.F.R. § 483.15(h)(1).

In its summary overview, Windsor argued that FFCL 10 (F-Tag 252, Level E) was not supported by substantial evidence. RR at 26; P. Ex. 3, at 1. As with FFCL 9, Windsor failed to present further argument concerning this deficiency. For the reasons set forth in FFCL 9, we affirm FFCL 10.

FFCL 11. Petitioner was not in substantial compliance with the regulation concerning quality of care (compliance with physician's order) during the December 9, 1998 revisit survey. 42 C.F.R. § 483.25.

A facility's obligations regarding quality of care are set forth in 42 C.F.R. § 483.25, which states, in relevant part:

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.

Id. TDH cited this deficiency under F-Tag 309, at Level G. P. Ex. 3, at 3.

The ALJ described how upon admission on December 8, this resident had a physician's order for a time-released Duragesic pain medication patch, but facility staff was unaware of the order until the surveyor inquired on December 9. The facility had previously told the resident (erroneously) that he could have only Tylenol for pain relief. After the surveyor pointed out the physician's order, the facility ordered the Duragesic patch, which was received and applied the next day (December 10). The ALJ considered and rejected Windsor's argument that since it had given the resident other pain medication pending receipt of the patch, the resident's needs were met. The ALJ concluded that the resident received the medicated patch two days late, which caused unnecessary suffering during the delay. ALJ Decision at 22-23.

On appeal, Windsor did not deny that it failed to obtain the Duragesic medication patch as ordered on December 8. Windsor further did not deny that the resident experienced some degree of pain after re-admission to the facility. Instead, it argued that ALJ erred by finding that "the resident unnecessarily suffered pain," which resulted in actual harm. RR at 64. Windsor also maintained that Surveyor Copeland's testimony concerning the resident's expressions of pain was not credible, since her observations were not documented in her notes and nurse notes on December 8 and 9 do not mention resident pain. Id. Windsor further argued that the Duragesic patch "was not an effective form of pain relief," requiring additional pain medication. RR at 65. Windsor finally argued that in order to find a deficiency, the ALJ should have concluded that the care plans or comprehensive assessments must have also been deficient. RR at 66. As to the undisputed fact of the failure to follow the physician's order, Windsor argued that "no one is perfect." Reply at 39.

We affirm the ALJ's finding. The crux of this deficiency is that Windsor did not provide the services and care ordered by the physician: a time-released pain medication patch ordered on December 8. Windsor did not contest that it failed to obtain the medication when and as ordered. P. Ex. 20, at 1 (December 8 physician order for "Duragesic patch 25 mg. to skin" every 72 hours). As we have held, the failure to comply with a physician's order can constitute a deficiency under F-Tag 309. See Batavia I at 35 (facility responsible for providing care ordered by physician), 36 (undisputed failure to comply with physician's order).

Windsor's argument concerning whether the resident experienced pain, or the degree of pain experienced, also misses the mark. The ALJ affirmed CMS's determination that the pain experienced by the resident caused "actual harm," which is one level of severity under CMS's categorization of deficiency seriousness. ALJ Decision at 22. In a CMP case, a facility may not appeal the seriousness of a deficiency assigned by CMS, based on the same facts, unless a successful challenge would change the range of CMPs available to CMS and, even then, the facility would have to demonstrate that the determination was "clearly erroneous." Windsor did not argue that either of those circumstances are present here. In any event, contrary to Windsor's argument, the surveyor's 5:55 PM notes are consistent with her testimony that she observed the resident in pain at that time. She wrote that the resident's "wife & daughter stated resident had been in pain since 12:30." CMS Ex. 12, at 9; Tr. at 366-67. It is reasonable to infer from this note that the resident had been and continued to be in pain at the time the surveyor spoke with the family and wrote the note.

Windsor also argued that nurse notes on December 8 and 9 do not support that the resident was in pain. Windsor stated that these notes show that resident was "admitted without complaints of pain" and that his needs were attended. RR at 64. Windsor failed to point out, however, that the December 8 nurse entry continues and states that the resident complained of pain in his extremities. P. Ex. 20, at 5. On December 9, nursing staff also documented "severe pain in upper and lower extremities." Id. Failure by nursing staff to document pain in two entries does not prove that the resident was not in pain, especially when accompanying entries on the same dates reflect pain. In any event, the extent of the resident's pain is irrelevant to Windsor's undisputed failure to comply with the physician's December 8 order for the Duragesic pain medication until the surveyor brought it to Windsor's attention.

Finally, we have held that a physician's order for evaluation of therapeutic interventions is reasonably considered "part of resident's comprehensive plan of care." Western Care Management Corp., d/b/a Rehab Specialties Inn, DAB No. 1921, at 70 (2004)(Rehab), citing 42 C.F.R. §§ 483.20(b), 483.20(k). We reached this conclusion, in part, by recognizing that "since the facility must ensure that each resident receives care and services necessary to attain and maintain the highest practicable level of well-being, the regulations cannot reasonably be read as permitting a facility to evade the obligation to provide any needed specialized services simply by failing . . . to incorporate them into the comprehensive care plan." Id. We affirmed the deficiency in Rehab, noting that there was no evidence to indicate that the physician had rescinded the order for therapy evaluation, "but there is evidence that [the facility] failed to follow through on those orders." Id. We conclude here that failure to follow physician's orders for pain management similarly involves the resident's plan of care.

Accordingly, we affirm FFCL 11.

FFCL 12. Petitioner was not in substantial compliance with the regulation concerning quality of care (nutrition) during the December 9, 1998 revisit survey. 42 C.F.R. § 483.25(i)(1).

This deficiency was also cited in the November 18 survey and is discussed in Section 2.A., supra, FFCL 1. A facility's obligations regarding quality of care and parameters of acceptable nutritional status are set forth in 42 C.F.R. § 483.25(i)(1). CMS cited this deficiency during the December 8 revisit under F-Tag 325, at Level E. P. Ex. 3, at 5. The CMS 2567 states that the facility "failed to ensure the nutritional needs" of some residents "who require assistance with feeding and/or residents at high nutritional risk." Id. at 6.

The ALJ described how seven out of nine residents had gained weight since the initial survey. However, he found that during the revisit survey, the facility had to use the administrator, the Director of Nursing, a nurse consultant, a social worker, and a restoration nurse to assist in feeding residents. Further, Windsor erroneously fed a resident prior to a medical procedure, which caused the cancellation of that procedure. ALJ Decision at 23, citing CMS Ex. 1, at 32 ("Daughter c/o that this is the 2nd x the facility goofed-up on prep for a colonosopy [sic].") Meal consumption cards were not dated, thus causing problems tracking nutritional intake. Resident likes and dislikes were not honored, and trays continued to be sent to the wrong locations. The ALJ determined that these circumstances posed the risk of more than minimal harm. ALJ Decision at 23-24.

In its summary overview, Windsor argued that FFCL 12 was not supported by substantial evidence. RR at 27. As with FFCLs 9 and 10, Windsor failed to present further argument concerning this deficiency. However, in its Reply, Windsor remarked that the evidence submitted by CMS "failed to establish that a deficiency existed" and the ALJ erred by affirming a deficiency based on the risk of harm. Reply at 40.

First, Windsor's failure to articulate the basis for its appeal does not comply with the regulatory requirement that Windsor specify in its request for review the findings of fact and conclusions of law with which it disagrees and "the basis for contending that the findings and conclusions are incorrect." 42 C.F.R. § 498.82(b)(emphasis supplied); Guidelines. Windsor simply listed FFCL 12 in its Request for Review, then offered nothing else until after CMS filed its Response (which contains no reference to this deficiency) before mentioning the issue in its Reply. We find that this scenario is inconsistent with the regulatory requirement that the basis first be raised in the Request for Review.

Even if Windsor had adequately pled its appeal for this deficiency (and it did not), Windsor did not deny the ALJ's finding that at least two of the residents failed to gain weight by the time of the revisit survey. Windsor further did not deny the deficient practices found by the ALJ. Moreover, contrary to Windsor's argument, the ALJ did not err by finding a deficiency based on risk of harm. The scope and severity grid makes clear that a deficiency exists even if it may not yet have caused harm to a resident, but instead presents the potential for more than minimal harm. See SOM § 7400.E.1, Levels A-F; 42 C.F.R. § 488.404(b)(1). The potential for harm not yet realized equates with the risk of that harm. The ALJ thus committed no error by finding that the facility failed to demonstrate substantial compliance with a condition of participation and that failure posed a risk of harm to residents.

Accordingly, we affirm FFCL 12.

FFCL 13. Petitioner was not in substantial compliance with the regulation concerning infection control during the December 9, 1998 revisit survey. 42 C.F.R. § 483.65(a)(1)-(3).

A facility's obligations regarding infection control are set forth in 42 C.F.R. § 483.65, which states, in relevant part:

The facility must establish and maintain an infection control program designed to provide a safe, sanitary, and comfortable environment and to help prevent the development and transmission of disease and infection. (a) Infection control program. 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.

Id. TDH cited this deficiency under F-Tag 441 at Level E. P. Ex. 3, at 8. The CMS 2567 states that Windsor failed to implement its infection control policy for one resident. Id. at 9.

The ALJ described how Resident 10 had wounds infected with Methicillin Resistant Staphylococcus Aureus (MRSA), a contagious infection requiring prophylactic isolation measures consistent with facility policy. ALJ Decision at 24, citing CMS Ex. 14, at 4, 16, 38. Facility contact isolation policy required that MRSA isolation policies and protocols remain in place "until a clear culture has been obtained." CMS Ex. 14, at 7. On December 10, the surveyor observed that Resident 10's room contained no signs warning of the need for MRSA precautions and that a nurse aide did not dispose of gloves consistent with facility policy and protocols after providing care. ALJ Decision at 24, citing CMS Ex. 14, at 16. The ALJ considered and rejected Windsor's argument that a laboratory had faxed preliminary test results indicating that the resident did not have MRSA. Id. at 25.

Windsor argued on appeal that it complied with the regulation by having in place an effective Infection Control program. Windsor then argued that on December 9, it had been faxed preliminary results of a wound culture indicating that the resident did not have MRSA by the time of the surveyor's observation on December 10. RR at 69; P. Ex. 22, at 2. Windsor alternately maintained that the fax was received on December 10th. Reply at 41.

We find no flaw in the ALJ's careful and reasoned consideration of the evidence and his inferences therefrom. ALJ Decision at 25. It is undisputed that on December 9, the resident's physician ordered a wound culture to determine the presence of MRSA. CMS Ex. 14, at 43; P. Ex. 21, at 15. The record contains a final laboratory report with two dates, December 9 and December 17, purporting to confirm negative MRSA culture results. ALJ Decision at 25, citing P. Ex. 21, at 1. The ALJ concluded that the December 9 date was not labeled and "could just be the date the culture was ordered or the date the culture was obtained or collected." Id. We agree that this report does not support that Windsor was faxed a preliminary negative result on December 9.

Windsor supported its position by placing into evidence a declaration in lieu of testimony from Director of Nursing JoAnn Appleton. Ms. Appleton states: "On . . . December 10, 1998, The Windsor House had been faxed the results of a wound culture taken the day before which revealed that the Resident was no longer MRSA positive." P. Ex. 22, at 2 (emphasis supplied). The ALJ accorded little weight to this statement, finding it "self-serving." ALJ Decision at 25. Our review indicates that Ms. Appleton's statement leaves unclear whether the purported negative results "had been faxed" to the facility on December 9 or on December 10. Windsor did not submit into evidence a fax which showed negative results. Windsor also submitted no nurse or physician notes indicating negative results received on either December 9 or 10. Windsor also submitted no evidence or argument that any negative results had actually been communicated to any member of the staff by the morning of December 10, including the nurse aide observed by the surveyor.

Instead, it is undisputed that at 10:45 AM on December 10, a therapist responsible for changing the wound dressings for Resident 10 told the surveyor that sterile techniques were in use and staff placed "dirty" dressings in a "red bag." CMS Ex. 14, at 16; CMS Ex. 14, at 5 (isolation precaution that "a laundry hamper and waste containers are placed in/near the isolation room and that each is lined with a red plastic liner."). Windsor also did not dispute that five minutes later, the surveyor observed a nurse aide who had provided care to the resident place her used gloves in the garbage can, which was lined with a black bag. Id. Windsor also did not dispute that ten minutes after that, the Director of Nursing failed to mention the purported faxed report when queried about isolation procedures for Resident 10. Id. Instead, the DON explained that red bags and isolation signs were not used because "it upsets the staff & they are afraid they will catch something." Id. However, the regulation as a whole makes clear that it is not enough simply to have an infection control program, but the facility must also follow the precautions established in that program. In short, the evidence of record supports that Windsor failed to maintain its isolation procedures for Resident 10 before a clear culture had been obtained.

Accordingly, we affirm FFCL 13.

FFCL 14. The amount of the CMP is reasonable.

The ALJ concluded that the three per day CMPs of $5,000 (November 18-23), $1,000 (November 24-December 10), and $250 (December 11- 16) were reasonable in amount. In reaching this conclusion, he cited to 42 C.F.R. § 488.438(f) as establishing the factors guiding his analysis. ALJ Decision at 26. He noted that each of the CMP amounts was at the lower end of the allowable ranges, the facility had a history of noncompliance, and the facility was culpable "due to the nature of the nutrition related deficiencies and the potentially severe impact on its residents." Id. He further noted that Windsor submitted no evidence on its financial condition and, thus, he inferred that Windsor could afford the CMP imposed. Id. He concluded that as a result of Windsor's compliance history, culpability, and deficiency scope and severity, the CMPs imposed were reasonable. Id.

Windsor presented four arguments on appeal. First, Windsor argued that there was "no evidence" supporting a deficiency under the nutrition regulation (42 C.F.R. § 483.25(i)(1)). RR at 70; Reply at 41-42. Windsor then argued that CMS's assessment of immediate jeopardy was clearly erroneous. Id. at 70-75. Windsor further argued that immediate jeopardy "was not based on an immediate risk of harm to the residents." RR at 73. Windsor also complained that CMS witnesses could not confirm that CMS considered the appropriate factors in setting the CMP. RR at 74-75; Reply at 41.

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

An ALJ may find that the basis for imposing a CMP exists when a facility is "not in substantial compliance with one or more participation requirements." 42 C.F.R. § 488.430(a), cross-referenced by 42 C.F.R. § 488.438(e). We have long held that "even one isolated instance of non-compliance having a potential for more than minimal harm may be the basis for a finding" that a facility is not in substantial compliance with a participation requirement and, thus, "may lead to the imposition of a CMP." Batavia I at 23, citing Ridge Terrace, DAB No. 1834, at 6 (2002) and Lake City.

i. The ALJ had a basis for imposing the CMP, as the cited deficiencies are supported by substantial evidence and without legal error.

We reject Windsor's argument that the ALJ had no basis for imposing a CMP. As we stated in Batavia I, the facility "'simply asserts that what we and the ALJ have found not to be true, namely, that it' was in substantial compliance with program requirements." Batavia I at 60, citing Livingston at 25. We have affirmed that substantial evidence supports the ALJ's findings that Windsor was not in substantial compliance with program requirements from November 18 through December 16, 1998. As a result, we find that the ALJ had a basis for upholding the imposition of a CMP.

ii. Windsor bears the burden of arguing factors in 42 C.F.R. § 488.438(f) to challenge CMP reasonableness.

A facility bears the burden of introducing evidence or argument challenging specific regulatory factors at 42 C.F.R. § 488.438(f) for determining the reasonableness of the CMP amount.

[W]hile the ALJ must consider evidence which is properly presented to him concerning any of the factors listed in 42 C.F.R. § 488.438(f) . . . in evaluating whether the CMP is within a reasonable range, CMS does not automatically have to offer such evidence as part of its prima facie case. Rather, if a facility contends that its financial condition or some other factor makes a CMP unreasonable, then the facility must raise that contention on a timely basis before any question would arise as to CMS's responsibility for producing evidence as to that factor.

Clermont at 31, citing Community Nursing Home, DAB No. 1807, at 22 (2002), Emerald Oaks, DAB No. 1800 (2001), and Batavia I at 62 ("As we have held, the ALJ need consider only those factors for which the parties submitted evidence.")

Windsor argued that the ALJ erred by placing the burden of proof on it regarding its financial condition (and, by extension, the remaining factors concerning CMP reasonableness). RR at 70. However, CMS's November 25, 1998, notice of the CMP states that CMS considered the factors at 42 C.F.R. § 488.438(f) in establishing the amount of the CMP. P. Ex. 2, at 2. As Clermont makes clear, Windsor must then identify those specific factors in 42 C.F.R. § 488.438(f) that it seeks to challenge and submit supporting argument or evidence. The ALJ correctly found that Windsor's failure to present argument or evidence on its financial condition conceded that issue. ALJ Decision at 26.

iii. CMS's finding that immediate jeopardy existed is not clearly erroneous.

"Immediate jeopardy" occurs when noncompliance "has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident." 42 C.F.R. § 488.301. (35) CMS's "Guidelines for Determining Immediate Jeopardy" explain that a facility's failure to provide adequate nutrition triggers an inquiry for immediate jeopardy. SOM, App. Q, § IV, at Q-5. Only one resident need be at risk if an immediate jeopardy determination will prevent the same risk to others. Id., § III, at Q-3. "The serious harm, injury, impairment, or death may have occurred in the past, may be occurring at present, or may be likely to occur in the very near future as a result of the jeopardy situation." Id., § IV, at Q-4. "Harm does NOT have to occur before considering Immediate Jeopardy." Id. (emphasis in original). When a survey team determines that immediate jeopardy exists, it must provide verbal notice to the facility prior to leaving in order that the facility may take steps to abate the immediate jeopardy condition. Id., § VI.C., at Q-16.

A facility may challenge CMS's determination of the level of noncompliance when the deficiency is cited at the immediate jeopardy level. Koester at 8, citing 42 C.F.R. § 498.3(b)(14) and Carehouse at 15. (36) In a CMP case, we must uphold CMS's assessment of immediate jeopardy determination unless clearly erroneous. 42 C.F.R. § 498.60(c)(2). The clearly erroneous standard imposes a "high burden" for the facility to meet. Koester at 9.

The ALJ made the following finding concerning immediate jeopardy:

I find that Petitioner's failure to comply with the regulation at 42 C.F.R. § 483.25(i)(1) put its residents in immediate jeopardy. Extreme weight loss is dangerous, particularly for frail residents of a nursing home. It affects an organ's ability to function, makes it difficult to fight infection, promotes skin breakdown and the development of pressure sores, and can ultimately make elderly people more likely to die. Tr. 106-108.

ALJ Decision at 14.

Surveyor Ray explained that an immediate jeopardy assessment is appropriate when "conditions that can be life threatening to the residents [exist] because of the quality of care that is being provided." Tr. at 102. She stated that immediate jeopardy was the correct assessment in this case "because of the high weight loss, the chaos in the [dietary] department, the decline of the residents and the psychological effect with the residents being upset . . . ." Id. at 162. She noted that "the severe weight loss was the most concern" in concluding that the deficiency constituted immediate jeopardy. Id.

We have upheld the ALJ's findings that Residents 1, 14, 15, 2, and other residents (7, 16, 17, 26, 27, 28, 29, 30, and 31) experienced unplanned and undesired weight loss. The ALJ found that Windsor failed to follow physician's orders, plan for, and exhaust treatment options for Resident 1, and failed to properly assess, treat, and react to weight loss for Residents 14, 2, and 15. ALJ Decision at 14. He further noted systemic problems with providing nutrition to residents, including failure to provide adequate feeding assistance, deliver food trays to the right location, accommodate resident food preferences, and serve food at the appropriate temperature. Id.

In affirming these deficiencies, we considered and rejected Windsor's arguments (reasserted here) that some residents had stable weights in the six months prior to the survey, that compliance with the regulation was not possible because of resident clinical conditions, and that the testimony of surveyors and witness Janet Watts lacked credibility. We find those arguments unavailing to demonstrate clear error in the assessment of immediate jeopardy as well.

Immediate jeopardy is sustainable when a facility's noncompliance has caused or is likely to cause serious injury, harm, or impairment to a resident. Windsor has failed to demonstrate that CMS was clearly wrong in determining that the deficient practices either caused or were likely to cause serious injury, harm, or impairment.

iv. The ALJ's findings concerning Windsor's history of noncompliance and culpability are supported by substantial evidence.

Windsor maintained that the ALJ erred by relying upon its history of noncompliance, (37) since CMS can increase a CMP only if a facility has been previously fined for the repeated deficiency. RR at 4, citing 42 C.F.R. § 488.438(d)(2). Section 488.438(d)(2) reads as follows:

CMS does and the State must increase the per day penalty amount for any repeated deficiencies for which a lower level penalty amount was previously imposed, regardless of whether the increased penalty amount would exceed the range otherwise reserved for nonimmediate jeopardy deficiencies.

Id.

This regulation does not address CMS's discretion to impose a CMP as a remedy for noncompliance that constitutes immediate jeopardy. Rather, section 488.438(d)(2) states that CMS may increase the amount of a CMP imposed for per day noncompliance that is a repeated deficiency. SOM, § 7516.C.3. Contrary to Windsor's argument, an ALJ is not required as a part of assessing a facility's history of noncompliance under section 488.438(f)(1) to determine whether a CMP was previously imposed for the same deficiency.

Instead, section 488.438(f)(1) requires only that the ALJ consider the facility's history of noncompliance, which can include repeated deficiencies. He or she is not required to determine whether the CMP has been increased from some previous amount assessed for a repeated deficiency. The ALJ is to consider whether the facility's history of noncompliance, taken as a whole, reasonably supports the amount of the CMP imposed. We conclude that he did so here.

Elsewhere, Windsor framed its argument as "[a] CMP which falls within the lower range of penalties may not be increased to the upper range based on the presence or absence of factors described in 42 C.F.R. § 488.404 and 488.438(f) unless the deficiency at issue is a repeated deficiency." RR at 8, citing 42 C.F.R. §§ 488.438(a)(1), 488.438(d)(2-3) (emphasis in original). Windsor's reading of the regulation is incomplete. Subsection (a)(1) provides that CMS may impose a CMP in the upper range for deficiencies constituting immediate jeopardy "and as specified in paragraph (d)(2) of this section." 42 C.F.R. § 488.438(a)(1)(i). Subsection (d)(2), in turn, simply provides that per day CMPs are to be increased for repeated deficiencies, regardless of whether such an increase might result in upper range CMPs for nonimmediate jeopardy deficiencies. To the extent that Windsor suggested that CMS may select an upper range CMP for immediate jeopardy only when the deficiency is a repeated deficiency, that assertion is erroneous.

Windsor also argued that the ALJ erred by assigning culpability for the nutrition deficiency based upon "the nature of the nutrition related deficiencies and the potentially severe impact on its residents." RR at 5. In essence, Windsor maintained that since those factors are accounted for under 42 C.F.R. § 488.438(f)(3) (which incorporates the factors in 42 C.F.R. § 488.404), the ALJ erred by including them in his analysis of section 488.438(f)(4). We disagree. We see nothing in the language of section 488.438(f) that supports this reading.

Under section 488.438(f)(4), culpability is defined as including (without limitation) "neglect, indifference, or disregard for resident care, comfort or safety." The nature of the nutrition related deficiency (as previously discussed) is the failure to ensure that residents receive adequate nutrition. The record reflects multiple instances of Windsor's failure to ensure that residents ate, to monitor weight loss, and to follow through with recommendations from its dietitian. We agree that these failures compromised the care, comfort, and safety of the residents. The harm to residents who suffered the severe weight losses is self-evident. Batavia I at 63, citing Livingston at 25 and 42 C.F.R. § 488.438(f)(4) (failure to follow physician orders and care plans, and actual harm to residents, "reflects some degree of culpability").

Accordingly, we affirm FFCL 14.

Conclusion

For the above reasons, we affirm the ALJ Decision as modified herein and sustain the CMP (totaling $48,500) imposed in this case. In doing so, we find that the reversal of the ALJ's finding concerning Resident 5 under FFCL 1 is not material to the amount of the immediate jeopardy CMP, as we affirm findings concerning 13 other residents under the same deficiency.

JUDGE
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Judith A. Ballard

Cecilia Sparks Ford

Donald F. Garrett
Presiding Board Member

FOOTNOTES
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1. CMS offered its exhibits marked as "HCFA" exhibits. As the agency changed its name from HCFA to CMS in 2001, any reference to a "CMS Exhibit" in this decision refers to an exhibit of the same number marked as a "HCFA Exhibit."

2. The seriousness of a deficiency is designated by a letter (A through L) that corresponds to the scope-severity matrix in section 7400.E of the SOM.

3. TDH cited F-Tags 252 (clean environment), 325 (acceptable parameters of nutritional status), and 441 (infection control) in both the initial and revisit surveys.

4. Section I addresses certain procedural arguments concerning hearsay evidence, uncited residents, Resident 2, and the admission of additional CMS exhibits after the initial exhibit deadline. ALJ Decision at 3-4. Section II summarizes applicable statutory and regulatory provisions.

5. See "The Windsor House's Request for Review of Decision No. CR1039" and accompanying "Memorandum of Law In Support of the Windsor House's Appeal of ALJ Decision No. CR1039," dated July 18, 2003.

6. Windsor did not appeal FFCL 3 (housekeeping), FFCL 4 (accident prevention), and FFCL 8 (pharmacy services). RR at 26. Windsor listed FFCLs 9 and 10 as a part of its appeal, but presented no supporting argument, as explained below.

7. We necessarily condense the arguments presented, as Windsor's Request for Review totaled 81 pages, CMS's Response Memorandum totaled 105 pages, and Windsor's Reply totaled 43 pages.

8. This section addresses a portion of Windsor's contentions concerning procedural error. We address Windsor's arguments concerning culpability, repeated deficiencies, and certain aspects of burden of proof in our analysis of CMP reasonableness.

9. At various points throughout its pleadings, Windsor cited to the ALJ and two appellate decisions in the Hillman case. For clarity, we state here each of those decisions and Windsor's short form citation. Hillman Rehab. Ctr. v. CMS, DAB CR419 (1996)(Hillman)(RR at 3); Hillman Rehab. Ctr. v. CMS, DAB No. 1611 (1997)(Hillman II)(RR at 2); Hillman Rehab Ctr. v. CMS, DAB No. 1663 (1998)(Hillman III)(RR at 13, n.9). In this decision, the Board uses the short form "Hillman" to refer to DAB No. 1611 (1997).

10. Several of Windsor's pinpoint citations to the various Hillman decisions are unsupported. For example, Windsor quoted Hillman II as stating, in part, that "Petitioner cannot be required to establish that determinations are clearly erroneous when [CMS's] determinations carry no presumption of correctness . . . ." RR at 77-78, citing Hillman II at 22, n.17. The quotation does not appear where cited or elsewhere in the decision. Windsor also quoted Hillman II as requiring that CMS "at least show that its material conclusions are supported by the evidence and are based on a correct interpretation of the laws and regulations." Id. at 79 (emphasis deleted), citing Hillman II at 22, n.17. This quotation is also absent from the cited footnote. Windsor's pinpoint citation to the ALJ decision also does not support its contention that "survey findings are often cursory and conclusory." Id. at 77, citing Hillman, DAB CR419, at 9 (1996). This phrase is from the first appellate decision, supporting placement of the initial burden of coming forward with evidence on CMS, rather than the provider. Hillman at 23-24.

11. See "First Amendment to the Health Care Financing Administration's Response to Petitioner's Objection to Exhibits Proposed by the Health Care Financing Administration," dated July 20, 2000. Attachment to Request for Review.

12. We reject for similar reasons Windsor's due process arguments concerning the ALJ's reference to CMS Exhibits 43 (food temperature) and 48 (privacy). See Reply at 11, n.9, citing ALJ Decision at 15, 19.

13. "A qualified dietitian is one who is qualified based upon either registration by the Commission on Dietetic Registration of the American Dietetic Association, or on the basis of education, training, or experience in identification of dietary needs, planning, and implementation of dietary programs." 42 C.F.R. § 483.35(a)(2).

14. The SOM establishes guidelines for determining the significance of weight loss that are consistent with the ALJ's statement. Under the SOM, "significant" weight loss occurs when the resident loses 5% of body weight in one month, 7.5% in three months, and 10% in six months. SOM, App. PP, at PP-106. "Severe" weight loss occurs when it exceeds those percentages within the same time period.

15. These factors mirror headings in CMS's post-hearing reply brief. Windsor frequently argued that the ALJ merely adopted CMS's arguments in reaching his findings. RR at 3, 36; Reply at 16. We find no error in his consideration of these factors, in conjunction with unplanned weight loss, in determining that Windsor was not in substantial compliance with program requirements.

16. As we have pointed out, the preamble to the regulations explains that the term "ensure" is used where a requirement relates to services a facility undertakes to provide and for which it is paid.

17. Commentary to the rule states that CMS does "not anticipate that there will be many circumstances in which the facility could allege that the maintenance of nutritional parameters was not possible." 54 Fed Reg. 5316, 5335 (February 2, 1989).

18. Windsor maintained that the regulation also requires that the resident suffer malnutrition before a deficiency may be cited. RR at 30, citing P. Ex. 5, at 5 (Petitioner's Exhibit 5 hereinafter SOM, Appendix PP); Reply at 14-15. The ALJ correctly noted that neither the regulation nor the SOM require indicia of malnutrition before a deficiency may be cited for failure to maintain adequate parameters of nutritional status. ALJ Decision at 6. Similarly, the regulation does not require surveyors to cite care planning or resident assessment deficiencies as a precondition to or in conjunction with this deficiency. Cf. RR at 30, n.17.

19. We have noted that the phrase that a facility "must do everything in its power" to achieve compliance does not track the language of the regulation. Clermont at 21, n.20 (citations omitted). We conclude here that the ALJ applied the correct standard in his analysis.

20. The agency may conduct other surveys "as frequently as necessary" to determine compliance and confirm the correction of previous deficiency citations. 42 C.F.R. § 488.308(c).

21. CMS defines "Minimum Data Set (MDS)" as being a "core set of screening and assessment elements . . . that forms the foundation of the comprehensive assessment for all residents of long term care facilities certified to participate in Medicare or Medicaid. The items in the MDS standardize communication about resident problems and conditions within facilities, between facilities, and between facilities and outside agencies." SOM, § 4145.2 (emphasis supplied).

22. An RAI is "[a]n instrument which requires for completion the performance of a standardized assessment system, comprised of the MDS and utilization guidelines (including the RAPs and triggers). This assessment system provides a comprehensive, accurate, standardized, reproducible assessment of each long term care facility resident's functional capabilities and identifies medical problems." SOM, § 4145.2 (emphasis supplied).

23. An RAP is a "structured, problem-oriented framework[] for organizing MDS information, and additional clinically relevant information about an individual that identifies medical problems and forms the basis for individualized care planning." SOM § 4145.2 (emphasis supplied).

24. We note that the MDS at CMS Exhibit 10, at 7-9 is marked "Resident 4," not Resident 14. Windsor explained that Resident 14 in the November survey is the same individual as Resident 4 in the December survey. Reply at 35; see CMS Exs. 10 (Resident 4) and 49 (Resident 14). The height, weight, and medical record numbers on the MDS for Resident 4 are identical to the same information on the Nutritional Assessment for Resident 14. Compare CMS Ex. 10, at 10 with P. Ex. 10, at 2.

25. A "bolus" is defined as "a rounded mass of food or a pharmaceutical preparation ready to swallow, or such a mass passing through the gastrointestinal tract." Dorland's Illustrated Medical Dictionary 223 (27th ed. 1988).

26. The November 2 entry indicates that the resident's weight was stable "as of 9/98," but ignores the severe weight loss that occurred during October. The entry for October weight is blank.

27. The record reflects that the resident also had a right hand contracture which was treated in November with a right hand roll. P. Ex. 11, at 4. This suggests that self-feeding may have presented significant difficulties for this resident over the months and that, in light of the continued weight loss, other interventions were needed.

28. The identifying information at the bottom of the care plan for Resident 15 is different than on the care plan for Resident 5. Compare P. Ex. 11, at 6-9 with CMS Ex. 11, at 13-15.

29. CMS advises state surveyors to document information on federal forms that include the "Surveyor Notes Worksheet" (HCFA 807) and "Resident Review Worksheet" (HCFA 805). CMS advises surveyors that this documentation will be the basis for deficiency citations. Batavia Nursing and Convalescent Inn, DAB No. 1911, at 2-3, n.4 (2004)(Batavia II).

30. The surveyor notes cite residents by name and room number, not resident number.

31. In reaching this conclusion, we need not consider the facility's assertion that the 13 pound weight loss recorded between September and October (from 93 to 80 pounds) or the recorded November 23 weight of 95 pounds were errors.

32. The facility's monthly weight record reflects the resident's weight on March 11 as 99 pounds and on April 12 as 87 pounds. P. Ex. 13, at 3. The quarterly nutritional assessment reflects a March weight of 99 pounds, an April 17 weight of 99 pounds, and an April 24 weight of 86 pounds. P. Ex. 13, at 7. Windsor offered no explanation why its nursing staff documented 87 pounds on April 12, while the dietary staff showed a 99 pound weight five days later, followed by a 13 pound drop two weeks later.

33. The SOM defines "pattern" as "when more than a very limited number of residents are affected . . . and/or the situation has occurred in several locations, and/or the same resident(s) have been affected by repeated occurrences of the same deficient practice." SOM, App. P, § V.C. A pattern also exists when a facility has "an adequate system/policy" that is "inadequately implemented in certain instances" or it has "an inadequate system with the potential to impact only a subset of the facility's population . . . ." Id. at § V.D.

34. "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 (emphasis supplied); see also 42 C.F.R. § 498.82(b).

35. Immediate jeopardy may exist regardless of the scope of a deficiency, but not regardless of its severity. Barn Hill Care Center, DAB No. 1848, at 19, n.20 (2002).

36. The seriousness of non-immediate jeopardy citations may thus not be challenged. Koester at 8. Thus, we leave undisturbed CMS's Level F assessment of the deficiency for insufficient staffing in the November 8 survey (F-Tag 353) and the Level G assessment of the quality of care deficiency in the December 10 revisit survey (F-Tag 309).

37. As a part of pre-survey preparation, CMS advises state surveyors to review a facility's OSCAR (Online Survey, Certification, and Reporting) reports "to determine if the facility has patterns of repeat deficiencies in particular tags or related tags." SOM, App. P, at P-6. The OSCAR review here indicated Windsor's history of noncompliance, with previous citations for resident injuries, pressure ulcers, incontinence, and nutrition (weight loss) at Level G. CMS Ex. 28, at 1.

CASE | DECISION | ANALYSIS | JUDGE | FOOTNOTES