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


SUBJECT: Florence Park Care Center,

Petitioner,

DATE: July 13, 2004

             - v -

 

Centers for Medicare & Medicaid Services

 

Docket No. A-04-26
Civil Remedies C-02-646
Decision No. 1931
DECISION
...TO TOP

FINAL DECISION ON REVIEW OF
ADMINISTRATIVE LAW JUDGE D
ECISION

Both Florence Park Care Center (Florence) and the Centers for Medicare & Medicaid Services (CMS) appealed a September 30, 2003 decision by Administrative Law Judge (ALJ) Steven T. Kessel. Florence Park Care Center, DAB CR1091 (2003) (ALJ Decision).

The ALJ determined that Florence was not in substantial compliance with 42 C.F.R. § 483.25(h)(2), which requires a facility to provide residents with adequate supervision and assistance devices to prevent accidents, and that this noncompliance placed residents in immediate jeopardy from April 8 through April 14, 2003. For this period of immediate jeopardy, CMS had imposed a civil money penalty (CMP) of $10,000 per day. The ALJ reduced this CMP to $3,050 per day and sustained the other remedies imposed by CMS.

In its request for review, Florence contended that the ALJ's findings were based on unreliable hearsay evidence, and that CMS failed to offer evidence sufficient to establish that the facility was not in substantial compliance with section 483.25(h)(2). In addition, Florence contended that CMS's immediate jeopardy finding was erroneous, that the immediate jeopardy (if it existed at all) was abated prior to April 8, 2002, and that the ALJ erred in failing to impose a per instance CMP and in failing to remand the case to CMS to reconsider its decision to impose a denial of payment for new admissions. In its appeal, CMS challenged the ALJ's decision to reduce the CMP for the period of immediate jeopardy from $10,000 per day to $3,050 per day.

For the reasons below, we reject Florence's contentions concerning the adequacy of CMS's evidence and affirm the ALJ's conclusion that Florence was not in substantial compliance with all Medicare participation requirements during the period in question (from April 8 through May 19, 2002). We also affirm the ALJ's conclusion that CMS's immediate jeopardy finding was not clearly erroneous, and conclude the ALJ committed no error in refusing to impose a per instance CMP or to remand the case to CMS. In addition, we affirm the ALJ's conclusion that the $10,000 per day CMP for the period of immediate jeopardy was not reasonable. However, we conclude that the magnitude of the reduction in the CMP for the period of immediate jeopardy -- from $10,000 per day to $3,050 per day -- was not justified by an analysis of the regulatory factors that the ALJ was obligated to consider.

Because neither party suggested that further proceedings before the ALJ would be necessary in the event that we set aside his ruling concerning the reasonableness of the CMP for the period of immediate jeopardy, we have decided not to remand the case. Instead, we modify the ALJ Decision to incorporate our own conclusion on that issue. We conclude, based on the relevant regulatory factors, that $4,000 per day is a reasonable CMP for the period of immediate jeopardy. Finally, we sustain the other remedies imposed in this case: a $100 per day CMP from April 15, 2002 through May 19, 2002, and a denial of payment of new admissions from April 27 through May 19, 2002.

REGULATORY BACKGROUND

Florence is a skilled nursing facility (SNF) that participates in the Medicare program. Medicare's participation requirements for SNFs and other long-term care facilities are set forth in 42 C.F.R. Part 483.

Compliance with Medicare participation requirements is verified through surveys performed by state agencies under agreement with CMS. The survey agency reports any "deficiencies" on a standard form called a "Statement of Deficiencies" (SOD). See 42 C.F.R. § 488.325(a); CMS State Operations Manual (SOM), Appendix (App.) P, sec. IV. A "deficiency" is a failure to meet a participation requirement in 42 C.F.R. Part 483. 42 C.F.R. § 488.301. Deficiency findings are organized in the SOD under alpha-numeric "tags," with each tag corresponding to a regulatory requirement in Part 483. See SOM, App. P, sec. IV.

A survey agency's findings include a determination about the "seriousness" of each deficiency. See 42 C.F.R. § 488.404. The seriousness of a deficiency includes its "scope" and "severity." See SOM, App. P, sec. V. "Severity" refers to whether a deficiency has created the "potential for harm," resulted in "actual harm," or placed residents in "immediate jeopardy"; "scope" refers to whether the deficiency is "isolated," constitutes a "pattern," or is "widespread." Id.; see also 42 C.F.R. § 488.404(b)(1). A deficiency's seriousness is designated in the SOD by a letter (A-L) that corresponds to a matrix reflecting different combinations of scope and severity. See SOM § 7400(E). The most serious deficiencies are those that place residents in "immediate jeopardy." "Immediate jeopardy" is defined in the regulations as a situation in which a deficiency "has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident." 42 C.F.R. § 488.301.

A facility becomes subject to remedial action when it is not in "substantial compliance" with one or more participation requirements. See 42 C.F.R. § 488.400. A facility is not in substantial compliance when there is a deficiency that has resulted in at least the "potential for more than minimal harm." See 42 C.F.R. §§ 488.301 (definition of substantial compliance).

The regulations authorize CMS to impose various remedies, including civil money penalties (CMPs), to encourage facilities to correct deficiencies promptly. CMS selects a remedy based on the survey agency's determination of the seriousness of the noncompliance and other relevant factors. See 42 C.F.R. §§ 488.404, 488.406 and 488.408. (The term "noncompliance" is defined in section 488.301 of the regulations to mean "any deficiency that causes a facility to not be in substantial compliance.")

A CMP in the "lower range" range of $50-$3,000 per day may be imposed for noncompliance that does not place residents in "immediate jeopardy" but that either causes actual harm or creates the potential for more than minimal harm. 42 C.F.R. § 488.438(a)(ii). For noncompliance that places residents in immediate jeopardy, a CMP in the "upper range" of $3,050 to $10,000 per day may be imposed. 42 C.F.R. § 488.438(a)(i). A per day CMP may accrue until the facility achieves substantial compliance or its provider agreement is terminated. 42 C.F.R. § 488.454(a). CMS may also impose a CMP in the range of $1,000 to $10,000 for "each instance that a facility is not in substantial compliance." 42 C.F.R. §§ 488.430, 488.438(a)(2).

A facility may not appeal CMS's decision to impose a particular remedy. See 42 C.F.R. § 488.403(g)(2). A facility may, however, appeal the findings of noncompliance that led to the imposition of a remedy. 42 C.F.R. §§ 488.408(g)(1), 498.3(b)(13). The scope of review includes whether the amount of the CMP is reasonable. See 42 C.F.R. § 488.438(e)(3); Capitol Hill Community Rehabilitation and Specialty Care Center, DAB No. 1629 (1997). In evaluating whether the amount of the CMP is reasonable, an ALJ may consider only the factors specified in 42 C.F.R. § 488.438(f). 42 C.F.R. § 488.438(e)(3). A finding by CMS that a facility's noncompliance has placed residents in immediate jeopardy "must be upheld unless it is clearly erroneous." 42 C.F.R. § 498.60(c)(2); Woodstock Care Center, DAB No. 1726, at 9, 38 (2000), aff'd, Woodstock Care Center v. Thompson, 363 F.3d 583 (6th Cir. 2003).

CASE BACKGROUND

On April 8, 2002, the Kentucky Cabinet for Health Services (KCHS) completed a survey of Florence. See CMS Ex. 3. The Statement of Deficiencies (SOD) for this survey cited Florence for noncompliance under tags F221, F225, F323, and F324. Id. Under tag F324, KCHS asserted that three of Florence's residents -- Residents 2, 1, and 3 (whom we discuss in that order throughout this decision) -- had not received adequate supervision and assistance devices to prevent accidents, as required by 42 C.F.R. § 483.25(h)(2). Id. at 11-18. KCHS determined that Florence's noncompliance with section 483.25(h)(2) was at level J on the seriousness scale, meaning that it was "isolated" and had placed residents in immediate jeopardy. CMS Ex. 3, at 11; CMS Ex. 4, at 1. CMS accepted the immediate jeopardy finding and notified Florence that it was imposing a $10,000 per day CMP effective April 8, 2002 (and continuing until the jeopardy was removed or the facility's participation was terminated). CMS Ex. 4, at 2. CMS also advised Florence that a denial of payment for new admissions (DPNA) would take effect on April 27, 2002 if substantial compliance with all Medicare participation requirements was not achieved by that date. Id.

On April 16, 2002, Florence submitted a plan of correction (POC) alleging, inter alia, that the immediate jeopardy (relating to tag F324) had been abated as of April 15, 2002. CMS Ex. 2; Florence Ex. 37. KCHS responded that the POC was unacceptable because it omitted certain elements concerning the deficiencies cited under tags F225 and F323. Florence Ex. 32. On May 3, 2002, Florence submitted an amended POC, asserting that substantial compliance with all requirements would be achieved by May 20, 2002. See CMS Ex. 3.

At some point, KCHS and CMS accepted Florence's assertion that residents were no longer in immediate jeopardy as of April 15, 2002. Accordingly, on May 10, 2002, CMS issued a second notice concerning remedies. CMS Ex. 4, at 5. The May 10 notice stated that the following remedies were being imposed: a CMP of $10,000 per day from April 8, 2002 through April 14, 2002; a CMP of $100 per day from April 15, 2002 until the facility achieved substantial compliance; and a DPNA to take effect on April 27, 2002 and continue until the facility achieved substantial compliance. Id. at 6.

On May 21, 2002, KCHS conducted a revisit survey. See CMS Ex. 11, at 1-2. The revisit survey established that Florence had achieved substantial compliance with all Medicare participation requirements as of May 19, 2002. CMS Ex. 4, at 8.

ALJ PROCEEDINGS

Florence appealed the remedies imposed by CMS by requesting an ALJ hearing. Pursuant to a pre-hearing order, CMS submitted proposed exhibits to support the survey agency's determination that Florence had failed to provide Residents 2, 1, and 3 with adequate supervision or assistance devices to prevent accidents. These exhibits included the SOD, the survey team's worksheets, resident medical records, and the records of meetings held by the committee that oversaw efforts to prevent residents from falling. See CMS Exs. 3, 5, 7-10. The survey team's worksheets contained handwritten notes by Donna Demaree, R.N., a KCHS surveyor whose inspection and interviews were the basis for the findings in the SOD under tag F324. See Tr. at 14; CMS Ex. 5, 8, 9. In addition, CMS presented the written direct testimony of Tamar L. Greenly, R.N., a KCHS regional program manager with prior experience as director of nursing in a nursing facility. (1) CMS Ex. 11. Nurse Greenly did not participate in the April 2002 survey of Florence.

Shortly after CMS's submission of proposed exhibits, Florence submitted its proposed exhibits and a pre-hearing memorandum. Florence's proposed exhibits included the written direct testimony of three witnesses (Steve Boymel, Jim Lark, and Kurt Haas) and various documents. These witnesses testified that the facility had come under new ownership on April 1, 2002, approximately one week before the initial survey, and that the new owner had taken aggressive action to correct quality of care problems at the facility. See Florence Exs. 35, 36, 38. Florence's witnesses did not dispute the survey findings or offer opinions about the care furnished to Residents 2, 1, and 3. Nor did these witnesses rebut any of the statements made by Tamar Greenly (CMS's witness). And, except to suggest that Resident 2's death had been caused by the emergency medical technicians who transported him to the hospital on March 12, 2002, Florence did not, during or prior to the hearing, dispute any of the statements of fact in the SOD. See Petitioner's Prehearing Brief (dated December 8, 2002); Petitioner's Proposed Supplemental Prehearing Brief (dated May 19, 2003). Instead, Florence focused on whether the CMP was reasonable and whether CMS had an adequate basis to impose a DPNA.

At the beginning of the hearing, Florence objected to the admission of the surveyor's notes and worksheets (contained in CMS Exhibits 5, 8, and 9) on the ground that their author, Donna Demaree, was not present to authenticate them. Tr. at 10-11. CMS did not include Demaree on the list of proposed witnesses submitted prior to the hearing, and Florence did not ask the ALJ to subpoena her. In addition, Florence did not, before or during the hearing, object to the admission of the SOD or contend that it was unreliable or inaccurate in any general or particular respect.

In its post-hearing brief, Florence contended, inter alia, that CMS had failed to make a prima facie showing of noncompliance because its evidence consisted entirely of unreliable hearsay statements from the SOD, unauthenticated surveyor notes and other statements of questionable reliability, and testimony by a nurse (Tamar Greenly) who did not participate in the survey and who was unfamiliar with relevant documentation. Florence PHB at 1-4.

THE ALJ DECISION

Based largely on the facts alleged or statements made in the SOD concerning Residents 2, 1, and 3 (see ALJ Decision at 3-6), the ALJ determined that CMS had made a prima facie showing of noncompliance with section 483.25(h)(2), stating:

There is a common thread that runs through the facts of this case and which is demonstrated by CMS's prima facie evidence. Residents #s 1, 2, and 3 all had disabilities or afflictions that made them prone to falling and vulnerable to injuries from falls. Petitioner was aware of each resident's problems. Its staff planned interventions were designed to address these problems. However, the interventions were not carried out, thereby putting the resident at risk. Moreover, Petitioner's staff failed to execute on plans which were intended to protect the entire resident population and not just Residents 1, 2, and 3. The Petitioner's staff understood the need to check the batteries of safety alarms but failed to implement a plan to do so. It is this failure to execute interventions which were specifically designed to benefit individuals or to benefit the resident population in general which, in my judgment, occurred with sufficient frequency to establish a prima facie case that Petitioner had systemic difficulties complying with the requirements.

ALJ Decision at 10. The ALJ rejected Florence's assertion that the "instances of noncompliance" involving Residents 2, 1, and 3 stemmed from "isolated errors" or "understandable oversights" rather than from a systemic failure to provide adequate supervision and assistance devices to its residents. Id. "The inference that I draw from the events described in the survey report," said the ALJ, "is that Petitioner was lax overall in assuring that common sense safety related plans were executed consistently by its staff." Id.

The ALJ also rejected Florence's contention that CMS's evidence consisted largely of unreliable hearsay and was, therefore, insufficient to constitute a prima facie showing of noncompliance with section 483.25(h)(2). ALJ Decision at 7-9. In addition, the ALJ found that CMS's immediate jeopardy determination was not clearly erroneous, and that the immediate jeopardy resulting from Florence's noncompliance continued from April 8 through April 14, 2002. Id. at 11-12.

The ALJ then considered whether the $10,000 per day CMP for the period of immediate jeopardy (April 8 to April 14, 2002) was reasonable based on the regulatory factors in 42 C.F.R. § 488.438(a)(1)(i). In explaining his inquiry, the ALJ stated that his task was "not to decide whether a reason exists to 'warrant changing' CMS's penalty amount determination" but to "evaluate de novo any evidence" relating to the regulatory factors and determine whether they supported the CMP imposed. ALJ Decision at 12-13. The ALJ determined that the evidence did not support a $10,000 per day CMP, the maximum permitted by the regulations. In support of that determination, the ALJ discussed the decision he had issued in Wellington Specialty Care, DAB CR548 (1998), which involved a resident who died after her head became wedged between the siderails of the bed. The ALJ stated that he upheld the $10,000 per day CMP imposed in Wellington because there was evidence that the facility received but failed to act on specific warnings that unpadded siderails posed a danger to residents. Id. at 13. In contrast, said the ALJ, there was no evidence that Florence was "indifferent" to its residents' needs:

The failure to provide necessary supervision or assistance to Petitioner's residents in this case is a case of failure by staff to execute instructions that were delivered to them with good intentions by Petitioner's management or its supervisory staff. It is a failure to provide planned for care rather than disregard of the residents' basic requirements. Obviously, the consequences in this case were as serious as they were in Wellington. Petitioner's culpability for its deficiencies is not nearly so high as was the case in Wellington.

Id.

Based on these findings, the ALJ reduced the CMP for the period of immediate jeopardy from $10,000 per day to $3,050 per day. ALJ Decision at 13. The ALJ stated that his decision to set the CMP at $3,050 per day was not based on Florence's financial condition, and that the penalty was "high enough so as to impel Petitioner to assure that, in the future, it is sufficiently attentive to its residents' needs so as to avoid recurrences of the types of errors that occurred here." Id. at 13-14.

In addition to reducing the CMP for the period of immediate jeopardy (April 8 to April 14, 2002), the ALJ sustained CMS's decision to continue the CMP, at $100 per day, from April 15 through May 19, 2002. Id. at 14. Finally, the ALJ found that CMS was authorized to impose a DPNA from April 27, 2002 through May 19, 2002. Id. at 15.

STANDARD OF REVIEW

The standard for our review of an ALJ decision on a disputed issue of law is whether the ALJ decision is erroneous. Our standard of review on a disputed issue of fact is whether the ALJ decision as to that fact is supported by substantial evidence on the record as a whole. Guidelines - Appellate Review of Decisions of Administrative Law Judges Affecting a Provider's Participation in the Medicare and Medicaid Programs (www.hhs.gov/dab/guidelines/); South Valley Health Care Center, DAB No. 1691 (1999), aff'd, South Valley Health Care Center v. HCFA, 223 F.3d 1221 (10th Cir. 2000).

DISCUSSION

As indicated, both CMS and Florence appealed the ALJ Decision. We address Florence's appeal first.

1. Florence's appeal

Florence made six broad contentions in its request for review. First, Florence contended that the ALJ's finding that it was not in substantial compliance with section 483.25(h)(2) is not supported by substantial evidence. According to Florence, the evidence supporting the ALJ's findings consists entirely of unreliable hearsay statements and does not establish that the facility failed to provide Residents 2, 1, and 3 with adequate supervision or assistance devices. Florence Request for Review (RR) at 1-14. Second, Florence contended that the ALJ's reliance on hearsay evidence impermissibly lifted CMS's burden to establish a prima facie case of noncompliance. Id. at 13. Third, Florence contended that the ALJ erred in upholding CMS's finding of immediate jeopardy. Id. at 14. Fourth, Florence contended that the immediate jeopardy, if it existed at all, disappeared on the day that Resident 2 died and did not, as the ALJ found, persist until April 14, 2002. Id. at 16. Fifth, Florence contended that CMS should have imposed a per instance rather than a per day CMP for the period of immediate jeopardy. Id. at 19. Finally, Florence contended that the ALJ erred in refusing to remand the case to CMS to reconsider its decision to impose a DPNA. Id. at 21.

We consider each of these contentions in turn. Although we do not discuss in detail every argument presented, we considered each and every point in the parties' pleadings.

a. The ALJ's finding that Florence was not in substantial compliance with section 483.25(h)(2) is supported by substantial evidence.

(i) The ALJ's reliance on hearsay statements in the SOD was not improper.

Florence contended that the ALJ's finding of noncompliance must be set aside because it is based entirely or largely on unreliable hearsay statements contained in the SOD. Florence RR at 1-2, 5-6, 11. According to Florence, the SOD was "the only exhibit cited for facts that would constitute direct evidence of a deficiency," yet the SOD was not "signed or certified or prepared under oath of any kind" and should have been considered unreliable for that and other reasons. (2) Id. at 5-6. We find no merit to these contentions. (3)

Hearsay statements are admissible in a proceeding like this one even if they are inadmissible under the rules of evidence applicable to court proceedings. See 42 C.F.R. § 498.61. In addition, hearsay statements may constitute substantial evidence of noncompliance if they have sufficient indicia of reliability. See Pacific Regency Arvin, DAB No. 1823, at 14, n.6 (2002); Richardson v. Perales, 402 U.S. 389, 402 (1971). A number of factors may be considered in evaluating the reliability of a hearsay statement, including (but not limited to) whether: (1) the hearsay declarant is biased and has an interest in the result of the case; (2) the opposing party has the means to obtain the information contained in the statement and to verify its accuracy; (3) the opposing party can subpoena the declarant; (4) the statement is corroborated or contradicted by other evidence; (5) the statement is consistent with other statements made by the declarant; (6) the statement is signed or sworn to; and (7) the declarant is available to testify. See Richardson v. Perales, 402 U.S. at 402-06; Pacific Regency Arvin.

The ALJ's factual findings are, as indicated, based largely on the statements of fact in the SOD, which in turn are based on the observations, interviews, and research of Surveyor Demaree. Florence's apparent concern is with the reliability of those factual statements, not with their relevance. (4) Regarding that concern, the ALJ found:

In other cases I have found that hearsay evidence, while admissible in these proceedings, is not reliable. My rulings in these cases focused on the inherent lack of credibility of the declarants (for example, anonymous residents, or residents whose records revealed dementia) or on the inability of the party against whom the hearsay was offered to test the credibility of the declarants' statements. But, these are not problems with the statements that were contained in the report of the April 8 survey. The hearsay statements in this report are the surveyors' personal observations plus the admissions that are attributed to Petitioner's staff. I find these statements to be more credible on their face than the types of statements that I have found not to be reliable in other cases. Some of them are admissions that would be allowed into evidence under the Federal Rules of Evidence. Others are observations made by a trained surveyor. In any event, Petitioner had an opportunity to test the credibility of the declarants whose hearsay is contained in the April 8 survey report. Petitioner could have asked that I subpoena either the surveyor or the staff members whose admissions are contained in the report. It did not do so.

ALJ Decision at 7.

We find no grounds to set aside this evidentiary ruling because the ALJ identified sufficient indicia of the SOD's reliability, the most significant of which was that Florence could have asked -- but did not ask -- the ALJ to subpoena Surveyor Demaree to testify about her statements in the SOD. (5) Most of those statements contain information gathered from Florence's own records and employees. Given its access to these information sources, Florence had the opportunity -- and, presumably, the motivation -- to identify witnesses or to produce documents to test the accuracy of Surveyor Demaree's observations and reporting and to correct any misstatements of fact. However, in its pre-hearing submissions, Florence did not object to or challenge any of the specific factual allegations in the SOD or contend that they were inadequate to establish a prima facie case of noncompliance. In addition, none of Florence's witnesses testified about the factual underpinnings of CMS's deficiency findings. (6) And, except for written statements by nurses who assisted Resident 2 on March 12 -- none of which are inconsistent with the SOD -- Florence's exhibits contain no information relevant to the survey findings regarding Residents 2, 1, and 3.

Florence contended that the ALJ ignored or overlooked evidence that the statements in the SOD are inconsistent with the surveyor's handwritten notes. Florence RR at 11. However, as we discuss below, what Florence called "inconsistencies" are more accurately described as a few examples of survey findings that are not mentioned or fully reflected in the notes shown on the surveyor's worksheets. To the extent that the surveyor's notes were incomplete or had missing information, the ALJ addressed that issue by noting that Florence could have asked him to subpoena additional survey agency records but did not do so. ALJ Decision at 8. We find, in any event, that the few alleged "inconsistencies" identified by Florence are not significant and do not undermine the ALJ's reliance on the SOD because Florence did not dispute the statements of fact contained therein, and because the surveyor's notes and the SOD are consistent in virtually all material respects.

Florence also asserted that CMS failed to offer evidence of the surveyor's qualifications and suggested that the statements in the SOD should have been supported by evidence of the surveyor's "recorded observations" and the methods she used to acquire the reported information. Florence RR at 10-11, 12. These assertions reflect a misunderstanding of the parties' respective evidentiary burdens, as described in our prior decisions. See e.g., Batavia Nursing and Convalescent Center, DAB No. 1904 (2004). CMS must make a prima facie showing of noncompliance. CMS carries this burden if it explains the factual basis of its deficiency findings and presents evidence on disputed facts that, together with any undisputed facts, is sufficient to establish that the facility was not in substantial compliance with one or more participation requirements. Assuming that CMS carries its burden, the facility must establish by a preponderance of the evidence that it was, or is, in substantial compliance with the relevant participation requirements. See Beechwood Sanitarium, DAB No. 1906 (2004). Here, CMS submitted a SOD containing statements of fact that were, as discussed below, sufficient on their face to warrant a finding of noncompliance. Florence submitted no evidence to contradict those statements and otherwise failed to dispute them. Consequently, CMS was under no obligation to offer any additional corroborative evidence (such as testimony about the surveyor's qualifications). As our decisions make clear, CMS is obligated to present evidence only with respect to factual assertions that are in dispute. See Ross Healthcare Center, DAB No. 1896 (2003).

Florence suggested that it was unable to identify the source of some of the information in the SOD, noting that the deficiency findings regarding Resident 3 were based on interviews with an unidentified person named "Peggy." Florence RR at 10-11. However, Florence never alleged at the hearing that it could not determine her identity. "Peggy" Mulligan, the record shows, was the nurse responsible for fall prevention at Florence. See CMS Ex. 5, at 35; CMS Ex. 10. The ALJ correctly noted that the SOD does not identify her by name but by her job -- the "nurse responsible for the falls program" (CMS Ex. 3, at 15). We agree with the ALJ that Florence had adequate information to determine "Peggy's" identity.

Florence contended that the ALJ erred in characterizing some of the statements in the SOD as "admissions." Florence RR at 12. Even if the statements contained admissions, said Florence, they would be inadmissible under the Federal Rules of Evidence because they were presented in the form of triple hearsay and otherwise lacked "circumstantial guarantees of trustworthiness." Id. We reject this contention for the following reasons. First, the Federal Rules of Evidence do not apply in this administrative proceeding. 42 C.F.R. § 498.61. Second, even if the statements in the SOD are not admissions, (7) they were nevertheless properly considered by the ALJ because they have other, sufficient indicia of reliability (as discussed above). Third, to the extent that the SOD contains statements by facility staff that are contrary to Florence's interest, such statements are analogous to "admission[s] by a party exempt from the definition of hearsay" under Federal Rule of Evidence 801(d)(2) and thus bear sufficient indicia of reliability. See Omni Manor Nursing Home, DAB No. 1920 (2004), at 14; Hillman Rehabilitation Center, DAB No. 1663, at 18 n.12 (1998)(noting that admissions against interest are generally considered more reliable than self-serving testimony), aff'd, Hillman Rehabilitation Ctr. v. HHS, No. 98-3789 (GEB) (D. N.J. May 13, 1999).

For the reasons above, we conclude that the ALJ did not err in relying on the factual statements in the SOD. We next address the ALJ's determination that Florence was not in substantial compliance with section 483.25(h)(2) in its care of Residents 2, 1, and 3, and state why we conclude that his findings on all three residents are supported by substantial evidence in the record as a whole.

      (ii) Substantial evidence supports the ALJ's findings on Resident 2.

Section 483.25(h)(2) provides that a facility "must ensure" that "each resident receives adequate supervision and assistance devices to prevent accidents." In Woodstock Care Center, the Board analyzed the wording, context, and history of section 483.25(h)(2) and, based on that analysis, set out a framework for evaluating allegations of noncompliance with that requirement. Woodstock Care Center, DAB No. 1726, at 25-30 (2000)(citing 54 Fed. Reg. 5316, 5332 (February 2, 1989)), aff'd, Woodstock Care Ctr. v. Thompson, 363 F.3d 583 (6th Cir. 2003). The Board determined that although section 483.25(h)(2) does not hold a facility strictly liable for accidents that occur, it does require the facility to take reasonable steps to ensure that a resident receives supervision and assistance devices designed to meet his or her assessed needs and to mitigate foreseeable risks of harm from accidents. Id.; see also Odd Fellow and Rebekah Health Care Facility, DAB No. 1839 (2002). A facility is permitted the flexibility to choose the methods it uses to prevent accidents, but the chosen methods must constitute an "adequate" level of supervision and assistance devices under all the circumstances. See Woodstock Care Center at 28-35. What is "adequate" depends, of course, on the resident's ability to protect himself or herself from harm. Id.

Regarding Resident 2, the ALJ set out the following summary of the evidence, which we quote in its entirety:

• [Resident # 2] was profoundly disabled and at great risk for sustaining injuries due to falls. The resident had been hospitalized for fall-related injuries prior to his admission to Petitioner's facility. CMS Ex. 3, at 13. His disabilities, which put him at risk for additional falls, included dementia, a seizure disorder, and severe contractures of his extremities. Id., at 13.

• Resident # 2 fell while residing at Petitioner's facility. On February 13, 2002, the resident sustained a fall from a geri-chair. CMS Ex. 3, at 13. Petitioner's staff knew that Resident # 2 was unable to sit upright in a chair and had to be placed in a reclining position or he would fall forward. Id.

• Petitioner's staff had addressed the resident's risk for falling in the resident's plan of care. A care plan for the resident dated March 4, 2002 stated that the staff should: "be extra careful with all transfers and positioning relative to contractures." CMS Ex. 3, at 14.

• Normally, two persons would transfer Resident # 2 from his bed to a shower and assist with the bathing process. CMS Ex. 3, at 13. Petitioner's staff normally showered Resident # 2 in a reclining shower chair. Id. However, on March 12, 2002, the reclining shower chair was being repaired. Id. On that date, Petitioner's staff decided to shower the resident in an upright shower chair with a seatbelt for stability and support. Id. The staff seated the resident upright in the chair and secured the resident to the chair with the seatbelt.

• After showering the resident on March 12, 2002, in the upright chair, a nursing assistant rolled the resident to the entrance of the facility's shower stall and dried the resident off. CMS Ex. 3, at 13. The assistant unfastened the resident's seatbelt in preparation for transferring the resident to a geri-chair. The assistant then noted that the padding on the geri-chair, which was three to five feet away from the resident, was unfolded. Id. The assistant turned her back on the resident to arrange the pad. Id. As the assistant did so, Resident # 2 coughed and fell to the floor. Id.

After the fall the resident was transported to a hospital where he died. CMS Ex. 3, at 12. After an autopsy a physician concluded that Resident # 2 died: "Due to neurogenic shock, due to fracture of odontoid process [a fractured neck], due to fall." CMS Ex. 7, at 2-3.

ALJ Decision at 3-4. The facts contained in this summary are undisputed (8) and based largely on the uncontested statements in the SOD (CMS Ex. 3, at 12-14). They indicate that Resident 2 had conditions -- dementia, a seizure disorder, and severe contractures -- that put him at great or high risk for falling. He could not sit upright in a chair and had to be placed in a reclining position so that he would not fall forward. He had fallen from a geri-chair in the recent past. Given these circumstances, Resident 2 needed close and careful supervision when seated upright and unrestrained in a chair. Resident 2 did not, the record shows, receive this minimum level of supervision on March 12, 2002. Despite an instruction in the plan of care to be "extra careful" with his positioning (see CMS Ex. 5, at 22), and despite his vulnerability to falls and inability to sit upright, the nurse aide turned her back on Resident 2 while he was seated upright and unrestrained in a shower chair. Nurse Greenly testified that this action was "inexcusable," and that preventing residents like Resident 2 from falling requires "scrupulous supervision and use of assistance devices." CMS Ex. 11, ¶¶ 17, 13. Florence submitted no evidence to rebut that opinion and offered no reason why we should disregard it. The nurse aide clearly failed to take a reasonable and elementary precaution -- keeping her attention focused on a seated resident who was known to be unstable in that position. We conclude that there is substantial evidence in the record to support the conclusion (implicit in the ALJ Decision) that Florence failed to take reasonably practicable steps to mitigate the foreseeable risk that Resident 2 might fall from his seated (and unrestrained) position.

According to Florence, "institutional failures" were the basis of CMS's deficiency finding regarding Resident 2, yet CMS failed to uncover or present evidence of such failures. Florence RR at 4. For example, said Florence, although the nurse aide who supervised Resident 2 on March 12 was interviewed about his accident (see CMS Ex. 5, at 14), the surveyor's notes reflect no questioning about how she was trained, whether she was aware of the need to use extra caution with the resident, or whether her actions were consistent with the facility's instructions. Id. at 3-4. "Despite CMS's efforts to paint the picture of an institutional failure," Florence said, "the best case [CMS] showed with respect to this resident was an accident that resulted from a nurse's momentary lapse of attention, which was contrary to her explicit instructions to use extra care, and resulted in injury only because of the resident's unforeseen cough." Id. at 4.

The gist of Florence's argument is that CMS was required to show, as an element of its prima facie case, that the inadequate supervision of Resident 2 resulted from systemic or institution-wide failings in the delivery of health care. We find this proposition to be inconsistent with the survey findings and the regulations. Regarding the survey findings, the SOD does not state or suggest that the incident involving Resident 2 stemmed from "institutional" failures; the SOD alleged merely that Resident 2 received inadequate supervision on March 12. See CMS Ex. 3, at 12-14. Tamar Greenly, CMS's witness, characterized Florence's noncompliance as a "systemic, institutional failure with regard to accident prevention" (CMS Ex. 11, ¶ 24), but this characterization did not refer only to the survey findings regarding Resident 2. Moreover, nothing in her testimony implies that an "institutional failure with regard to accident prevention" was a factor that CMS considered necessary to show that Florence was not in substantial compliance.

In any event, section 483.25(h)(2) does not require CMS to provide evidence of an institutional failure. All that regulation requires is evidence that Florence failed to ensure that each resident received adequate supervision and assistance devices.

Requiring CMS to offer proof of the possible systemic or underlying cause of Florence's noncompliance is inconsistent not only with section 483.25(h)(2), but with the enforcement scheme set out in 42 C.F.R. part 488, subpart F. In Lake City Extended Care Center, DAB No. 1658 (1998), the Board reviewed ALJ findings that mirror the points raised by Florence. The ALJ in that case made a finding that the facility was in a state of noncompliance only on the day on which the facility failed to report a high temperature to the resident's physician. In support of that finding, the ALJ stated that the facility's failure to report the high temperature was "'only an isolated episode of [the facility] not complying with professionally recognized standards of care in providing care' to the resident, and there was not even 'a prima facie case of a generalized failure by [the facility] to comply with standards of care'[.]" Lake City, at 13-14 (citing the ALJ's decision)(footnote omitted). Concluding that the ALJ was required to find the facility noncompliant from the completion of the survey until the date of the resurvey in which substantial compliance was established, the Board noted that the ALJ's approach was "contrary to the regulatory scheme, which assumes that any deficiency that has a potential for more than minimal harm is necessarily indicative of problems in the facility which need to be corrected." Id.

Florence's suggestion that the deficiency involving Resident 2 stemmed entirely from a single nurse aide's lapse in judgment seems to be based partly on the notion that a facility should not be held accountable for the acts of its employees. We have rejected this proposition. See Cherrywood Nursing and Living Center, DAB No. 1845 (2002); Georgian Court Nursing Center, DAB No. 1866 (2002). Moreover, section 483.25(h)(2) requires the facility to "ensure" that its residents receive adequate supervision. Responding in the regulation's preamble to comments about requirements that hold the facility responsible for "ensuring" that residents receive proper care and treatment, CMS stated:

We recognize that a facility cannot ensure that the treatment and services will result in a positive outcome since outcomes can depend on many factors, including a resident's cooperation (i.e., the right to refuse treatment), and disease processes. However, we believe that it is reasonable to require the facility to ensure that 'treatment and services' are provided, since the basic purpose for residents being in the facility is for the 'treatment and services' and that is why the Medicare or Medicaid program makes payment on the residents' behalf. We also think it is reasonable to require the facility to ensure that the resident does not deteriorate within the confines of a resident's right to refuse treatment and within the confines of recognized pathology and the normal aging process.

54 Fed. Reg. at 5,316, 5,332 (Feb. 2, 1989)(emphasis added). Citing this statement, the Board in Woodstock concluded that --

while the regulations do not make facilities unconditional guarantors of favorable outcomes, the quality of care provisions do impose an affirmative duty to provide services (in this case, supervision and devices to prevent accidents) designed to achieve those outcomes to the highest practicable degree.

DAB No. 1726, at 28.

Here, a nurse aide diverted her attention from Resident 2 under circumstances that she knew or should have known called for close and careful supervision. She therefore did not ensure that Resident 2 received adequate supervision. Because Florence is responsible for the acts or omissions of its employees, it may not disavow responsibility for the noncompliance by arguing that the nurse aide failed to carry out instructions or act in conformity with her training.

Florence's last contention was that Resident 2's accident did not involve a violation of section 483.25(h)(2) because it was unforeseeable that Resident 2's cough would cause him to lose balance in the shower chair and fall. Florence RR at 4-5. This contention is totally without merit. The regulation required Florence to take reasonable steps to mitigate foreseeable risks of harm to Resident 2. In view of his overall condition, what Florence was obligated to mitigate was not the risk that a particular movement or physical reaction (such as a cough) would cause him to become unstable and fall, but the risk that he would -- for any reason -- fall suddenly from an upright seated position unless proper precautions were taken. Florence was indisputably aware of that risk.

In sum, we find substantial evidence in the record to support the finding that Resident 2 did not receive adequate supervision and assistance devices to prevent accidents.

(iii) Substantial evidence supports the ALJ's findings on Resident 1.

We quote the ALJ's summary of the evidence regarding Resident 1, which, like the summary regarding Resident 2, is based largely on the uncontested statements in the SOD:

• Resident # 1 . . . was . . . profoundly disabled and at a great risk for sustaining injuries due to falls. The resident suffered from Alzheimer's dementia and organic brain syndrome. CMS Ex. 3, at 14. On January 23, 2002, the resident fell while residing at Petitioner's facility, sustaining a broken hip. Id.; CMS Ex. 10, at 8. The resident also fell in November 2001, February 2002, and March 2002 while residing at Petitioner's facility. CMS Ex. 10, at 2, 4, 6, 8, 10.

• Some of the falls sustained by Resident # 1 occurred while the resident was unattended in her room. CMS Ex. 8, at 20, 55, 58-59, 61.

• Petitioner's staff attempted to place an alarm in Resident # 1's bed to alert the staff about attempts by the resident to leave her bed. However, the staff discontinued this effort in February 2002 when the resident was found with the alarm cord wrapped around her neck. CMS Ex. 3, at 15; CMS Ex. 10, at 5.

• On February 20, 2002, Petitioner's staff decided to obtain a different bed sensor alarm for the resident which would not expose the resident to hazards associated with the first alarm's cord. CMS Ex. 10, at 5. It was decided that, pending arrival of the new alarm, the wheels would be taken off of Resident # 1's bed and pads would be placed on the floor adjacent to the bed. Id.

• On April 6, 2002, the resident was observed at 10:00 and 11:25 a.m. to be lying in bed on her back. CMS Ex. 3, at 16. One side rail was observed to be up and the other was observed to be down. Id. Pads were stored in the resident's room but were not on the floor next to the side of the bed on which the bed rail was down. Id.

• On March 27, 2002, Petitioner's staff decided to put dycem on the seat of Resident # 1's wheelchair to prevent the resident from falling from the chair. CMS Ex. 3, at 16. Dycem is a material that is designed to increase friction and thereby to prevent an individual from sliding while seated.

• The resident was observed to be in her wheelchair on April 6, at 12:18 p.m., 12:55 p.m., and at 2:35 p.m., but no dycem was present in the resident's chair. CMS Ex. 3, at 16. During an interview, the nurse responsible for Petitioner's falls program admitted that she was unaware that the resident had not received dycem for her wheelchair seat. Id. She told the surveyor that she had told the unit manager to obtain the material and place it in the resident's chair but that she had not followed up to determine whether this instruction had been carried out. Id.

These findings, all of which are supported by the evidence cited by the ALJ, show that Resident 1 was at high risk for falling, that she had recently suffered a serious injury from a fall, and that she had fallen in her room. Aware of her vulnerability, the nursing staff determined that certain assistance devices -- bed sensors (9) or shock-absorbing floor pads next to her bed, and dycem on the wheelchair seat -- were needed to reduce the risk of accident and injury. However, the SOD reported that, on April 6, 2002, Resident 1 was seen lying in bed, with one of the siderails down, but with no bed alarm or bed sensor, and no floor pads on the side of the bed on which the siderail was down. The SOD also reported that Resident 1 was seen that day sitting in her wheelchair without any dycem on the seat, even though the nursing staff had determined that she needed this material to prevent her from falling out of the chair. These undisputed facts establish that Florence did not ensure that Resident 1 received necessary assistance devices to prevent accidents.

Florence made numerous arguments concerning Resident 1, none of which we find meritorious. First, Florence contended that CMS's evidence concerning this resident is insufficient to establish a violation of section 483.25(h)(2) because Nurse Greenly's declaration (CMS Ex. 11) and Surveyor Demaree's notes (CMS Ex. 8, at 1-7) do not explain whether Resident 1's risk of falling from bed related only to the side of the bed on which the bedrail was down, or to both sides of the bed (whether or not the siderail was down). Florence RR at 6-7.

We do not agree that such explanation was necessary. The nursing staff was obviously concerned about Resident 1 falling from her bed. She had done so prior to the survey. In fact, the SOD reported, and Florence did not dispute, that Resident 1 "fell out of bed [on February 17, 2002], and was found sitting on the floor next to the down side rail." CMS Ex. 3, at 15. Under the circumstances, it is reasonable to infer that the instruction to put down shock-absorbing floor pads was intended to enhance Resident 1's safety on the side of the bed on which siderail was down.

Next, Florence contended that there are "multiple reasons" why use of floor pads might have been unnecessary, even when one of the siderails was down (one side of the resident's bed might have been against the wall, for example). Florence RR at 7, n. 5. We agree with CMS that such speculation about the necessity of the floor pads is insufficient to undermine the ALJ's or the survey agency's findings. See Community Nursing Home, DAB No. 1807, at 12 n.5 (2002)(indicating that counsel's suppositions about the standards of medical care and other issues are not competent evidence). CMS offered credible (and uncontested) evidence that the floor pads were necessary. As the ALJ noted, Florence could have offered affirmative evidence to show that floor pads were, in fact, unnecessary under the circumstances, but it elected not to do so.

Florence contended that CMS failed to show any noncompliance involving a failure to put down floor pads because surveyors did not perform an independent evaluation of the factors that made it more or less likely that Resident 1 would fall from bed, such as the height of the bed, its position, how frequently she was checked, and other interventions that might have been adequate to prevent falls. Florence RR at 8. Under the circumstances here, however, CMS did not need to conduct such an evaluation. Although floor pads may not prevent a fall, their purpose is to prevent or reduce the likelihood of injury from accidental falls, and that is an outcome that the quality of care requirements in section 483.25 seek to achieve. See 42 C.F.R. § 483.25 (providing that the facility must provide the "necessary care and services" so that the resident can "attain or maintain [his] highest practicable physical, mental, and psychological well-being"). Moreover, under these regulations, Florence was obligated to provide care and services in accordance with the plan of care. Id. The undisputed facts were that Florence had planned for a bed sensor and then, when no operable bed sensor was available, ordered the floor pads as an alternative but failed to use them. These facts were sufficient to shift the burden to Florence to show substantial compliance. Florence submitted no evidence to meet that burden.

Florence made a number of contentions concerning the finding that Resident 1's wheelchair did not have dycem in the seat. It contended, for example, that the surveyor's notes fail to describe "how" the surveyor concluded that Resident 1's wheelchair seat did not have dycem on it. Florence RR at 8-9. However, the finding that there was no dycem in the wheelchair seat is based on an undisputed statement of fact in the SOD. See CMS Ex. 3, at 16. Consequently, CMS was under no obligation to submit any evidence to corroborate or verify it. We think it likely in any event that a surveyor could have reliably determined whether dycem was being used. Florence offered no credible reason why Surveyor Demaree's observations in this regard might have been inaccurate or unreliable.

Surveyor Demaree's notes indicate that Resident 1 was at or near a nurse's station when she was observed in her wheelchair at 2:35 p.m. on April 6. CMS Ex. 8, at 4. Florence contended that, because section 483.25(h)(2) requires a facility to furnish a resident with an effective combination of supervision and assistance devices, CMS was required to show that Resident 1 was not receiving adequate supervision from the nurse's station to prevent her from falling from her wheelchair. Florence RR at 9. The fact that Resident 1 happened to be near a nurse's station is not really relevant, however. The wheelchair was supposed to have dycem -- an assistance device - on the seat to reduce the risk of accidental harm, regardless of her location in the facility or proximity to the nursing staff. The undisputed fact that Resident 1 was up in the wheelchair without the dycem was sufficient to shift the burden to Florence to establish that the alleged deficiency did not create a potential for more than minimal harm because the nursing staff was actually supervising Resident 1 in a manner that compensated for the lack of dycem in her wheelchair. Florence produced no evidence that Resident 1 was supervised in such a manner.

Comparing the SOD and the surveyor's worksheets, Florence asserted that some of the SOD's findings regarding Resident 1 were "inconsistent" with the surveyor's handwritten worksheet notes. See Florence RR at 7-8. For example, the SOD states that on April 6, 2002, Resident 1 was twice seen in bed, once at 10:00 a.m., and a second time at 11:25 a.m. The SOD states that, in each instance, one bed siderail was observed to be up and the other down, and that shock-absorbing pads were not on the floor next to the side of the bed on which the siderail was down. Florence accurately asserted that the surveyor's notes regarding the 10:00 a.m. observation do not mention floor pads (see CMS Ex. 5, at 31), and that the notes regarding the 11:25 a.m. observation do not mention siderails (see CMS Ex. 8, at 4).

A second alleged discrepancy involves a statement in the SOD that Resident 1 was seen three times on April 6 -- at 12:18 p.m., 12:55 p.m., and 2:35 p.m. -- without dycem in her wheelchair. CMS Ex. 3, at 16. As Florence correctly asserted, the surveyor's notes for the 12:18 p.m. and 12:55 p.m. observations do not mention whether Resident 1's wheelchair had dycem. See CMS Ex. 8, at 4.

What the foregoing comparisons reveal is that the surveyor's notes do not contain all of the information contained in the SOD. Florence interpreted the omissions in the surveyor's notes as evidence that the surveyor did not in fact make the relevant observations (lowered siderails, missing floor pads, or a wheelchair without dycem). By themselves, however, the omissions create no conflict in the evidence; they merely show that the SOD contains more factual detail than the worksheets. The fact that the worksheets are less detailed than the SOD does not by itself render the SOD inherently suspect because the SOD is itself a contemporaneous record of the surveyor's observations and recollections. See Beechwood Sanitarium at 51 n.18 (rejecting contention that the absence of notes on the surveyor's worksheets was proof that the allegations in the SOD were not based on true contemporaneous observations by the surveyors). Of course, Florence could have used what it thought to be discrepancies in these documents to examine or cross-examine the surveyor about the accuracy or reliability of the SOD or offered evidence to contradict the SOD, but it did not do so. In sum, we find substantial evidence in the record to support the finding that Resident 1 did not receive adequate supervision and assistance devices to prevent accidents.

(iv) Substantial evidence supports the ALJ's findings on Resident 3.

The ALJ summarized the evidence regarding Resident 3 as follows (again, the summary is based largely on the uncontested statements in the SOD):

• Resident # 3 . . . was a high risk for sustaining falls. Resident # 3 fell from his wheelchair in December 2001 and from his bed on March 27, 2002. CMS Ex. 9, at 4. The resident suffered from dementia, impaired vision and hearing, and Petitioner's staff had assessed the resident as being a fall risk. CMS Ex. 3, at 16-17.

• Petitioner's staff determined that the resident should wear a body alarm while up and in bed in order to protect the resident against the risk of falling. CMS Ex. 3, at 17.

• The resident was observed by a surveyor on the afternoon of April 6, 2002. The resident was observed to be in a wheelchair in which he ambulated through Petitioner's locked Alzheimer's wing. CMS Ex. 3, at 17. The resident was not wearing a body alarm despite having been ordered to wear one. Id.

• The nurse responsible for Petitioner's falls program admitted that the resident's bed alarm had not sounded when the resident fell from his bed on March 27, 2002. CMS Ex. 3, at 17. The nurse averred that, prior to March 27, 2002, Petitioner's staff had not had a plan in place to check the batteries of alarms or to assure that the alarms actually worked. Id. As of the date of the survey the nurse was working on a system to assure that batteries were routinely checked. However, the system had not been implemented as of the date of the survey. Id., at 17-18.

What the foregoing evidence shows is that Florence, again, failed to provide an assistance device (a body alarm) to a vulnerable resident who was supposed to have the device for safety reasons. The evidence also indicates that Florence had not implemented procedures to ensure that alarm batteries were periodically checked and that alarms were in working order, despite an incident in which Resident 3's bed alarm should have sounded but did not. Tamar Greenly testified that battery-operated alarms, like the one that had been ordered for Resident 3, "play a critical role in protecting residents from falls," and therefore it is "standard policy and procedure in nursing facilities to test and/or replace batteries on a fixed schedule." CMS Ex. 11 ¶ 23. This testimony was unrebutted.

Florence contended that Resident 3 was not in danger of falling from his wheelchair on April 6, 2002 because he was wearing a seatbelt at the time. Florence RR at 9-10. However, it offered no evidence that the seatbelt alone afforded Resident 3 the necessary degree of safety.

Florence also asserted that "nothing in the record permits a leap from a report that the facility did not have a policy on checking batteries to the assumption that the batteries in Resident 3's alarm were not checked." Florence RR at 11. We find this assertion to be unavailing. What the ALJ and the surveyors found significant was that, at the time of the survey, Florence had yet to implement a plan to periodically check the batteries of safety alarms. ALJ Decision at 10. This failure certainly posed a risk not only to Resident 3 but to other residents.

    b. The ALJ did not relieve CMS of its evidentiary burden.

Florence contended that the ALJ effectively lifted CMS's burden of presenting prima facie evidence of noncompliance by relying on the SOD and by stating that the facility could have subpoenaed the surveyor and other hearsay declarants. See Florence RR at 13. By effectively requiring it to subpoena hearsay declarants, said Florence, the ALJ ignored "the fact that it is CMS who carries the burden to establish a prima facie case consisting of credible evidence concerning disputed facts." Id.

We have already described CMS's evidentiary burden in cases involving the imposition of a CMP or other remedy for alleged noncompliance with Medicare participation requirements. To reiterate, CMS must set forth the factual basis for its determination that the facility was not in substantial compliance. CMS must also come forward with evidence related to any disputed statement of fact.

Relying on the SOD, CMS identified the facts supporting its determination that the facility was not in substantial compliance with section 483.25(h)(2). At the hearing, Florence failed to dispute any material statement of fact in the SOD. (10) Florence also failed to object to the admission of the SOD. Under these circumstances, the ALJ was entitled to treat the facts alleged in the SOD as established and supportive of CMS's prima facie case. We therefore reject Florence's contention that the ALJ improperly relieved CMS of its burden to make a prima facie showing of noncompliance.

    c. CMS's finding of immediate jeopardy is not clearly erroneous.

Florence contended that the ALJ erred in upholding CMS's finding of immediate jeopardy, asserting that the ALJ "impermissibly based his Decision on hindsight, i.e., [on] the fact that Resident #2's fall occurred and resulted in death, rather than a proper legal analysis of what was foreseeable before the accident." Florence RR at 14. We find no merit to this contention.

Immediate jeopardy is defined in section 488.301 of the regulations as a "situation in which the provider's noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident." 42 C.F.R. § 488.301 (emphasis added). CMS's immediate jeopardy finding may be set aside only if it is "clearly erroneous." 42 C.F.R. § 498.60(c)(2).

The record contains unrebutted evidence that Florence's failure to provide adequate supervision and assistance devices, in violation of section 483.25(h)(2), was a proximate or contributing cause of Resident 2's fall on March 12, 2002, and that the fall resulted in serious injury (a 5 cm laceration on the forehead). See CMS Ex. 3, at 12-14. There is also evidence that the fall was the precipitating cause of Resident 2's death. In particular, an autopsy report states that Resident 2's death was "due to neurogenic shock, due to fracture of odontoid process, due to fall." CMS Ex. 7, at 2.

In addition, CMS presented evidence that the facility was sometimes lax in ensuring that two other extremely vulnerable residents (Residents 1 and 3) received and used necessary assistance devices to prevent accidental injury. Nurse Greenly testified, without contradiction, that falls commonly result in serious injuries, that residents with histories of fall-related injuries, like Residents 1 and 2, are more likely to suffer injuries from falls, and that hip fractures are a "particularly common, and potentially fatal, result of falls among nursing home residents." (11) See Tr. at 66; CMS Ex. 11, ¶ 8. In this case, two of the residents in question had histories of falls and serious fall-related injuries. See CMS Ex. 3, at 13 (fall by Resident 2 in March 2001 resulting in subdural and intercanial hematoma); CMS Ex. 3, at 14 (fall by Resident 1 in January 2002 resulting in hip fracture). All three residents were judged to be at "high risk" for falls. CMS Ex. 9, at 4; CMS Ex. 11, ¶¶ 17, 23. One could reasonably conclude from all this evidence -- and especially from the circumstances surrounding Resident 2's death -- that Florence's noncompliance with section 483.25(h)(2) had "caused" or "was likely to cause" serious injury or death and therefore placed them and other residents in immediate jeopardy. (12)

Florence bore a heavy burden to show that CMS's immediate jeopardy finding was clearly erroneous. Koester Pavilion. It did not carry that burden. Other than unsworn written statements by facility nurses that were submitted for the purpose of showing the fall was not a contributing cause of Resident 2's death (see Florence Ex. 34 and footnote 10 above), a proposition inconsistent with the autopsy report, Florence offered no evidence that the immediate jeopardy designation was erroneous.

Pointing to Tamar Greenly's testimony on cross-examination that injuries are "not necessarily likely" when a resident falls (Tr. at 46, 51), Florence suggested that the likelihood of harm, or immediacy of the threat of harm, was not great enough to put residents in immediate jeopardy, and therefore there was nothing to distinguish this case from ordinary or "garden variety" cases involving a facility's noncompliance with section 483.25(h)(2). See Florence RR at 14-15 & n.10. For purposes of determining that immediate jeopardy exists, however, the relevant inquiry is not the likelihood of injury from "a resident's fall," but the likelihood of serious injury from the facility's noncompliance. The likelihood of injury increases if the noncompliance is evidenced by a failure to provide adequate supervision or assistance devices to highly vulnerable residents, like Residents 2, 1, and 3, or by a failure to institute necessary safety procedures that protect many residents, such as Florence's failure to institute a policy for periodically checking alarm batteries.

Florence asserted that "institutional failures" (e.g., failures to implement care plans), rather than the "isolated errors" or "understandable oversights" documented in the SOD, were the basis for CMS's immediate jeopardy finding, and that CMS offered no evidence that such failures led to Resident 2's death or increased the risk of serious injury to Residents 1 and 3. Florence RR at 15. The undisputed facts discussed above, however, undercut Florence's view that the deficiencies involving these residents were only "isolated errors" or "understandable oversights." Moreover, there is evidence that Florence's shortcomings in fall prevention were not limited to Residents 2, 1, and 3. The findings of a quality review initiated by Florence's new owner indicate that residents other than the three mentioned in the SOD did not receive adequate supervision and assistance devices, and that fall prevention policies were not being fully or consistently implemented when the survey occurred. See Florence Ex. 4, at 4-5; Ex. 5; Ex. 7, at 2; Ex. 35, ¶ 20; Ex. 36, ¶¶ 4, 5, 18. Also, as discussed above, CMS did submit some evidence that Resident 2's death was due to the fall, and the undisputed fact that Florence failed to provide Residents 1 and 3 with the assistance devices it had determined were necessary to address their fall risks was certainly sufficient to shift the burden to Florence to show these failures did not increase the risks for those residents.

Thus, we agree with the ALJ that CMS's immediate jeopardy finding was not clearly erroneous.

    d. The ALJ's finding that the immediate jeopardy continued through April 14, 2002 is not erroneous.

Florence contended in its request for review that any immediate jeopardy ceased on the day that Resident 2 died, and that "CMS [had] presented no evidence that there were other residents similarly situated, such as residents who used the reclining shower chair, . . . [and] no evidence of other problems concerning staff errors providing supervision." Florence RR at 16. Asserting that the circumstances surrounding Resident 1 and Resident 3 were "markedly different in character" from the ones involving Resident 2 and were insufficient to establish immediate jeopardy, Florence contended that the ALJ's finding that the immediate jeopardy continued from April 8 through April 14, 2002 was based on an "erroneous perception" that the allegations concerning Residents 2, 1, and 3 showed a "pattern of problems" indicative of an "enduring institutional failure." Id. at 16-17.

The gist of this argument was presented to the ALJ, who rejected it. See ALJ Decision at 12. The ALJ found that, even if the problems associated with Resident 2's death had been corrected on or shortly after March 12, Florence had failed to show that the "omissions and failures" involving Residents 1 and 3 had been corrected prior to April 14. Id.

We find no reason to disturb the ALJ's finding. If a survey finds noncompliance, CMS may impose a per day CMP that may begin to accrue "as early as the date the facility was first out of compliance" and continue in effect until the facility alleges and establishes that it has achieved substantial compliance (or removed the immediate jeopardy). 42 C.F.R. § 488.440(a)(1); see also § 488.454; Regency Gardens Nursing Center, DAB No. 1858, at 6-11 (2002). There is no requirement that the duration of a remedy coincide with particular events that may constitute evidence of the facility's noncompliance. Regency Gardens at 21. A facility's noncompliance is deemed to be corrected or removed only when the incidents of noncompliance have ceased and the facility has implemented appropriate measures to ensure that similar incidents will not recur. See Lake City Extended Care Center at 14 (noting that "substantial compliance" means not only a showing that the noncompliance has not again occurred but that the facility has implemented a plan of correction to ensure that there is no recurrence). The same principle applies to a finding of immediate jeopardy: immediate jeopardy is deemed to have been removed only when the facility has implemented necessary corrective measures. See Fairfax Nursing Home, Inc., DAB No. 1794 (2001) (finding that CMS's determination that the facility had taken inadequate steps to abate the immediate jeopardy was not clearly erroneous), aff'd, Fairfax Nursing Home v. Dep't of Health & Human Servs., 300 F.3d 835 (7th Cir. 2002), cert. denied, 537 U.S. 1111 (2003); SOM, App. Q, sec. VII(A) (noting that "only onsite confirmation of the implementation of a facility's corrective actions justifies a determination that the immediate jeopardy has been removed").

Here, Florence submitted a plan of correction (POC) describing the steps it would take to remove the immediate jeopardy. Florence Ex. 37, at 11. In recognition of the circumstances that led to Resident 2's accident, the POC states that its corrective measures included "in-servicing of nursing staff . . . to ensure resident safety and staff understanding of resident positioning, assistance devices, physical restraints, and supervision of environment to prevent accidents/incidents." Id. The POC also indicates that the in-servicing was not completed until April 15, 2002. Id. (13)

Florence contended that the ALJ overlooked evidence that its new owner had spearheaded numerous improvements in the facility's management and quality of care. Florence RR at 17. Suggesting that these improvements had been aimed in part at correcting deficiencies cited in the SOD, Florence asserted that the "remedy for any systemic problems at FPCC relating to accident prevention was in place on the day surveyors arrived on April 6." Id. at 18. However, Florence did not point to any evidence supporting that assertion. Moreover, the assertion that all necessary corrective action had been taken by April 6 is at odds with the representations in Florence's POC.

Elsewhere, Florence suggested that it had removed the immediate jeopardy by April 12 (not April 14, as CMS found). Florence RR at 18. In a letter to the survey agency, Florence reported that it had implemented a number of measures as of April 12, including hazard removal, quality control procedures, and identification of residents at risk for accidents. CMS Ex. 2, at 1-2. However, the letter does not assert or demonstrate that Florence had completed the in-servicing of its nursing staff, a measure called for in the POC, prior to April 14. Id. at 1. In addition, the letter asks CMS to consider April 15, 2002 as the date on which Florence had taken "sufficient measures to eliminate the immediate jeopardy." Id. at 2. Florence did not address these circumstances in its request for review or argue that it was unnecessary to complete the in-servicing of the nursing staff in order to remove the immediate jeopardy.

Accordingly, we affirm the ALJ's finding that the period of immediate jeopardy did not end on the date of Resident 2's death and that it continued from April 8 through April 14, 2002.

e. The ALJ did not err in refusing to impose a per instance CMP.

In response to a request by Florence that he impose a per instance CMP in lieu of the per day CMPs imposed by CMS, the ALJ found that a per instance CMP was "inappropriate" because Florence's noncompliance was not an "instance" of noncompliance but instead "extended over a period of days." ALJ Decision at 14. The ALJ also found that "CMS's decision to impose per day penalties, rather than a per instance penalty is an act of discretion by CMS that I have no authority to overrule." Id.

In its request for review, Florence contended that CMS's regulations should be interpreted as permitting an ALJ to change the type of CMP imposed. Florence RR at 19. The choice between a per day or per instance CMP, Florence said, is "nothing more than a decision about the amount of the penalty," which the ALJ has the authority to review under section 488.438(a). Id. at 20. Florence asserted that, because the regulations do not characterize per day and per instance CMPs as different types or categories of "remedy," there is no basis for finding that CMS exercised any meaningful discretion in choosing between these two options, making review by the ALJ appropriate. Id. at 20-21. In addition, Florence asserted that a $1,000 per instance CMP was appropriate, suggesting that its noncompliance was a "one-time occurrence" and that the change of ownership on April 1, 2002 "moots the need for a painful penalty." See id. at 20 & n.11. Finally, Florence suggested that the ALJ abused his discretion in not imposing the per instance CMP because he "assume[d] a connection between the death of Resident #2 and the other examples that did not exist[.]" Id. at 19.

Relying on 42 C.F.R. § 498.3(d)(11), CMS responded that its selection of a per day CMP rather than a per instance CMP is a discretionary decision that the ALJ has no authority to review. CMS Response at 12-13.

We note that 42 C.F.R. § 498.3(d) identifies administrative actions that are not initial determinations and therefore not subject to appeal under Part 498. Scope of review in a CMP case is addressed at 42 C.F.R. § 488.438.

We need not address the legal issue raised by CMS concerning the scope of the ALJ's authority because the key factual premises of Florence's argument are unsupported or contradicted by the record. There is, for example, evidence that Florence's noncompliance stemmed not from "one-time" or isolated incidents, but from ongoing practices or lapses that continued to endanger resident health and safety until they were corrected or stopped. The facility's failure to have procedures to check alarm batteries is the most conspicuous example. The fact that Florence's noncompliance involved three residents, coupled with the findings of the quality review performed by James Lark (see Florence Ex. 4, at 4-5 and Ex. 5, at 1), is also some indication of systemic problems with respect to fall prevention.

In addition, Florence did not point to any evidence that CMS's decision to impose a per day CMP instead of a per instance CMP was motivated by a desire to set the amount of the CMP at a particular level. The relevant regulatory preamble makes it clear, moreover, that per instance CMPs were authorized not for the purpose of giving CMS an alternative method for calculating or setting the total penalty, but to give CMS added flexibility in choosing an effective remedy, particularly with respect to facilities with a pattern of correcting a cited deficiency before a CMP goes into effect then lapsing into noncompliance afterward. 64 Fed. Reg. 13,354, 13,355-13,356, 13,359 (March 18, 1999).

In light of these circumstances, we conclude that, even if the ALJ had the legal authority to impose a per instance CMP in lieu of the per day CMPs, Florence failed to show that his refusal to do so was arbitrary or an abuse of discretion. Thus, we find no error in the ALJ's determination not to substitute a per instance CMP for the per day CMPs.

    f. The ALJ did not err in failing to remand the case to CMS.

The regulations provide that CMS may impose a denial of payment for new admissions (DPNA) for the days on which a facility is not in substantial compliance. 42 C.F.R. §§ 488.417(a)(1) and 488.408(d)(3)(i). In this case, CMS imposed a DPNA that became effective on April 27, 2002. The ALJ ruled that imposition of the DPNA was "authorized here in light of Petitioner's continuing noncompliance through May 19, 2002," and that he had "no authority to direct CMS not to impose a remedy where CMS is authorized to impose one." ALJ Decision at 15.

In its request for review, Florence contended that the ALJ's refusal to remand the case to CMS to reconsider its decision to impose the DPNA was erroneous because the evidence showed that the facility was, for all practical purposes, in substantial compliance on April 27, the day the DPNA went into effect. See Florence RR at 21.

We find no merit to this contention. On April 29, 2002, the survey agency informed Florence that its plan of correction (POC) for the deficiencies under tags F225 and F323 did not identify certain required corrective measures. Florence Ex. 32. Florence suggested that, but for its failure to submit an approved POC addressing these "lower-level" (level D) deficiencies, CMS would have found it to be in substantial compliance on April 27. However, submission of an acceptable POC does not conclusively establish that a facility has achieved substantial compliance. Instead, "the regulations provide that substantial compliance must be established by a resurvey or after an examination of credible written evidence produced by the facility (which could be verified without an onsite visit)." Batavia Nursing and Convalescent Center, DAB No. 1904, at 58 (citing 42 C.F.R. § 488.454(a)(1)). In this case, the resurvey found that Florence did not achieve substantial compliance until May 19, 2002. Florence failed to submit or identify any credible evidence that substantial compliance was achieved earlier, such as proof of when it implemented the measures specified in its approved POC.

Florence contended that remanding to CMS to reconsider its decision to impose the DPNA is appropriate because the facts as found by the ALJ "were not nearly as extreme as CMS's original treatment -- imposing $10,000 per day penalties -- would suggest." Florence RR at 22. Florence asserted that CMS was "motivated to punish [it] to an unwarranted degree, and that its decision to deny payment for new admissions could well have been affected by a too-extreme view of the facts." Id. We reject this argument in part because the facts found by the ALJ were virtually identical to those found by CMS and the survey agency. Indeed, most of the ALJ's findings are based on the undisputed facts set forth in the SOD. In addition, CMS was clearly authorized to impose the DPNA because Florence remained in a state of noncompliance as of April 27, 2002. Under these circumstances, remanding the case to CMS would be an implicit recognition that Florence had a right to appeal CMS's decision to impose the DPNA, a right that the regulations expressly preclude. See 42 C.F.R. § 488.408(g).

For all the above reasons, we conclude that the ALJ did not err in refusing to remand this case to CMS to reconsider its decision to impose a DPNA.

2. CMS's Appeal

CMS contended that the ALJ's determination to reduce the CMP imposed for the period of immediate jeopardy from $10,000 per day (the highest permitted for an immediate jeopardy level deficiency) to $3,050 per day is not supported by substantial evidence. CMS RR at 8-11. In particular, CMS contended that the ALJ reduced the CMP based on a finding that Florence was not culpable for the deficiencies involving Residents 2, 1, and 3, even though 42 C.F.R. § 488.438(f)(4) expressly precludes an ALJ from reducing a CMP based on the "absence of culpability." Id. at 10. CMS also asserted that the ALJ failed to consider the fact that Florence's noncompliance had resulted in a resident's death. Id. at 9. According to CMS, the ALJ's finding that Florence was lax in implementing "common sense" approaches to protect "extraordinarily vulnerable" residents from "known and obvious risks" implicitly acknowledges that the facility was "indifferent" to resident health and safety and thus culpable for its noncompliance. Id. at 11.

In response to these contentions, Florence contended that the ALJ focused on the degree of its culpability and did not find the facility to be wholly without culpability. Florence Response at 3-4 & n. 2. Florence also asserted that the maximum CMP in the upper range ($10,000 per day) should be reserved for only the most egregious violations, and that its alleged noncompliance with section 483.25(h)(2) did not warrant such a penalty given the "flimsiness of the evidence" concerning culpability and the absence of other aggravating factors. Id. at 5-6. In addition, there was, Florence asserted, no evidence of any "pervasive institutional failure" that resulted in the deficiencies. Id.; Florence RR at 2-12. Finally, Florence asserted that a reduction in the penalty was appropriate because the recent change in ownership made future compliance likely, as evidenced by the prompt and substantial efforts of the new owners to improve the quality of care. Florence Response at 7-11.

An ALJ's assessment of whether the amount of the CMP is reasonable must be guided by the factors specified in (or cross-referenced by) 42 C.F.R. § 488.438(f). CarePlex of Silver Spring, DAB No. 1683 (1999). These factors are the facility's history of noncompliance, its financial condition, its culpability for the cited deficiencies, the seriousness of the noncompliance, and the relationship between or among the deficiencies. See 42 C.F.R. §§ 488.438(f) and 438.404. The ALJ must make an independent determination about "whether the evidence presented on the record concerning the[se] . . . regulatory factors supports a finding that the amount of the CMP is at a level reasonably related to an effort to produce corrective action by a provider with the kind of deficiencies found and in light of the other factors involved[.]" CarePlex at 8.

We find that the ALJ articulated an adequate reason for concluding that $10,000 per day for the period of immediate jeopardy is an unreasonable amount under the circumstances here. The ALJ found that Florence's culpability was "not nearly so high as was the case in Wellington," a case in which he imposed a $10,000 per day CMP. ALJ Decision at 13 (emphasis added). In making this finding, the ALJ drew a distinction between a facility (like the one in Wellington) that disregards a known risk of harm by failing to order necessary precautions, and a facility (like Florence) that is negligent or not diligent in ensuring that planned interventions are implemented. This analysis persuades us that the ALJ reduced the CMP not because he found that Florence wholly lacked culpability, but because he concluded that Florence did not exhibit the degree of culpability necessary to warrant the maximum CMP allowed under the regulations. The ALJ's conclusion was a valid basis for finding the $10,000 per day CMP unreasonable, and his decision to set that penalty aside was consistent with section 488.438(f) and our holding in Franklin Park Care Center, DAB No. 1900 (2003), both of which say that an ALJ may not reduce a CMP based on the "absence" of culpability. An ALJ is not precluded from reducing a CMP based on a finding that the facility was less culpable than CMS or the survey agency had supposed. Moreover, in determining what weight to give particular factors, other similar cases are relevant, and considering them leads to more consistent and fair enforcement.

We further conclude, however, that the ALJ did not adequately justify his determination that $3,050 per day was a reasonable amount for the CMP. That amount is the minimum that may be imposed for noncompliance resulting in immediate jeopardy. 42 C.F.R. § 488.438(a)(i). Absent aggravating factors (such as culpability or a history of noncompliance), this minimum penalty would ordinarily be appropriate for an immediate jeopardy level deficiency whose scope is only "isolated" and not a pattern or widespread. Florence's noncompliance with section 483.25(h)(2) was, in fact, determined by the survey agency to be isolated. CMS Ex. 3, at 11 (indicating that noncompliance was at level J). As Florence conceded, however, the ALJ found it to be culpable in some degree. The ALJ did not explain why the facility's lesser degree of culpability did not warrant a CMP somewhat higher than the regulatory minimum. As discussed below, the circumstances here support a conclusion that the degree of culpability warrants a CMP higher than the minimum.

The ALJ Decision also gives no indication that the ALJ considered the seriousness of the three other deficiencies found to exist during the period of immediate jeopardy (under tags F221, F225, F323), and for which he upheld a $100 per day CMP for the period of after April 14 (a penalty that Florence did not contest). Although Florence's noncompliance with section 483.25(h)(2) was the basis for CMS's decision to select a CMP within the upper range, the CMP actually imposed was based on all of the deficiencies found by the surveyors. See CMS Ex. 4, at 2 (indicating that the upper range CMP was based on the findings of the April 2002 survey). The ALJ should therefore have considered these three other deficiencies in deciding what was a reasonable amount.

Because we conclude that the ALJ did not consider all of the relevant regulatory factors, we set aside his finding that $3,050 per day is a reasonable amount for the period of immediate jeopardy. We find that a CMP somewhat higher that the $3,050 per day minimum is appropriate because, as discussed, Florence had three other, non-immediate jeopardy level deficiencies (all at level D) during that period. Moreover, we agree with the ALJ that Florence was culpable in some degree for its failure to comply with section 483.25(h)(2). This factor should be given substantial weight. The uncontested facts reveal that the nursing staff failed, without explanation, to implement accident precautions that had been prescribed for extremely vulnerable residents, and that the nurse in charge of fall prevention was unaware that precautions had not been implemented as ordered. See CMS Ex. 3, at 16 (fall prevention nurse not aware that floor pads were not being used in Resident 1's room and that dycem had not been placed in his wheelchair). Also, there was evidence that it is standard nursing practice to have a system for checking alarm batteries, yet 10 days after Resident 3's bed alarm failed to sound, the facility still had not implemented procedures for checking batteries in safety alarms. In light of the regulatory factors as a whole, (14) we conclude that a $4,000 per day CMP is reasonable for the period of immediate jeopardy.

The evidence that Florence's new owners took quick action to improve the quality of care at the facility was not a factor in our determination to set the CMP at $4,000 per day because Florence failed to allege or show that those efforts implicate one of the regulatory factors. In CarePlex, we held that the ALJ properly considered evidence of a new owner's expeditious efforts to correct deficient practices at the facility because that evidence served to rebut CMS's evidence of the facility's history of noncompliance. DAB No. 1683, at 11-13. Here, however, CMS offered no evidence of a history of noncompliance.

CONCLUSION

For the reasons above, we affirm all of the findings of fact and conclusions of law in the ALJ Decision except for the finding that a $3,050 per day CMP is reasonable for the period of immediate jeopardy (April 8 to April 14, 2002), which we set aside. Accordingly, we modify finding number 4, found on page 12 of the ALJ Decision, to state: "A civil money penalty of $4,000 per day is a reasonable remedy for the period of immediate jeopardy (April 8 through April 14, 2002)."

 

JUDGE
...TO TOP

Cecilia Sparks Ford

Donald F. Garrett

Judith A. Ballard
Presiding Board Member

FOOTNOTES
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1. Both parties submitted their witnesses' direct testimony in writing. The witnesses were cross-examined at the hearing.

2. At the hearing, Florence objected to the admission of the surveyor's notes and worksheets because they were not sworn and because the surveyor was not present to testify. Tr. at 10-11. Florence did not renew that objection before us.

3. CMS asserted that these contentions are not properly before the Board because Florence did not raise them before or during the hearing. CMS Response at 5. Our decisions indicate that an issue is properly before us as long as it was presented to the ALJ at some point before the decision is issued. See, e.g., Ross Healthcare Center, DAB No. 1896 (2003). The issues concerning the reliability of CMS's evidence were presented to the ALJ in Florence's post-hearing brief and were considered by the ALJ. They are therefore properly before us.

4. For purposes of this discussion, we assume that the statements in the SOD constitute hearsay in the legal sense.

5. We do not decide what is the appropriate standard for our review of an ALJ's evidentiary ruling because we would uphold the ruling under any standard.

6. Even in this appeal, Florence does not allege that there were any significant factual errors in the SOD. See, e.g., Florence RR at 2 (noting that the facts alleged with respect to Resident 2 are undisputed).

7. Florence did not specify the statements it believed might be covered by this part of its argument.

8. See Florence RR at 2 (noting that the facts alleged with respect to Resident 2 are undisputed).

9. Bed sensors and other alarms serve to alert the nursing staff of movements that may precede falls and also serve to remind cognitively impaired residents not to attempt to transfer without assistance. CMS Ex. 11, ¶ 23.

10. Florence contended in its pre-hearing brief that CMS had assumed, without sufficient evidence, that Resident 2's fall had caused the cervical fracture discovered on March 12, 2002. Relying on unsworn statements by facility nurses who described how emergency medical technicians prepared Resident 2 for transport to the hospital (Florence Ex. 34) and on other evidence, Florence suggested that the fracture "could have occurred incident to his transport" or might have been the result of a fall that occurred prior to March 12. See Petitioner's Prehearing Brief at 4-5. Contrary to what Florence argued, however, CMS did not merely "assume" that the fall caused Resident 2's cervical fracture but relied on an autopsy report (see below).

11. Nurse Greenly also testified that falls are among the most serious problems that nursing home residents can face; that elderly persons who require skilled nursing care are more likely to suffer falls than elderly persons who live independently; that the injuries that commonly result from falls include hip fractures, head traumas, lacerations, and concussions; and that falls often exact a heavy toll in terms of loss of independence and resulting isolation and depression. CMS Ex. 11, ¶¶ 8-10. She testified that prevention of falls and resulting injuries is among the most important responsibilities of a skilled nursing facility. Id. ¶ 10.

12. Florence suggested that Resident 2's death was irrelevant to the determination of immediate jeopardy. The regulations at 42 C.F.R. § 488.301, however, define immediate jeopardy to include a situation in which there is an actual causal relationship between the facility's noncompliance and a resident's death (as there was here). A finding that a facility's noncompliance caused the death of a resident is, of course, unnecessary if another part of the definition is met, but the death is relevant if caused by the noncompliance.

13. Florence contended that its circumstances were analogous to those faced by the facility in Price Hill Nursing Home, DAB CR745 (2001). Florence RR at 17. We disagree, but, in any event, the Board is not bound to follow an ALJ decision.

14. CMS did not offer evidence of any history of noncompliance, and Florence did not assert in the request for review that the ALJ acted improperly in refusing to find that its financial condition warranted a reduction in the CMP.

CASE | DECISION | JUDGE | FOOTNOTES