SUBJECT: Tri-County Extended Care Center,

Petitioner,

Centers for Medicare & Medicaid Services

FINAL DECISION ON REVIEW OF
ADMINISTRATIVE LAW JUDGE DECISION

On January 12, 2004, Tri-County Extended Care Center (Tri-County) appealed the November 7, 2003, decision of Administrative Law Judge (ALJ) Jose A. Anglada sustaining the determination of the Centers for Medicare & Medicaid Services (CMS) that Tri-County failed to comply substantially with federal requirements for the participation of long-term care facilities in the Medicare and Medicaid programs. Tri-County Extended Care Center, DAB CR1101 (2003) (ALJ Decision). A survey of Tri-County was conducted on April 20^th and 21^st, and on May 1, 2000, by the Ohio Department of Health, the State survey agency. The surveyors found that Tri-County was not in substantial compliance with several participation requirements, including one deficiency at the immediate jeopardy level for one day based on events surrounding a death on April 15, 2000. A revisit on May 26, 2000, found that the facility had returned to substantial compliance. The remedies ultimately imposed by CMS were (1) a civil monetary penalty (CMP) of $3,050 for one day, effective April 15, 2000, and (2) a CMP of $450 per day, effective April 16, 2000, through May 15, 2000.

The ALJ concluded that CMS was justified in imposing these remedies. The ALJ's finding of immediate jeopardy related to the death of a resident found entrapped in the side rails of his bed, which the ALJ concluded was the result of Tri-County's failure to provide adequate supervision and assistance devices in violation of federal regulations. ALJ Decision at 5-11; 42 C.F.R. � 483.25(h)(2) (cited as Tag F324). The ALJ found deficiencies relating to four other requirements at a level less than immediate jeopardy and concluded that the $450 per day CMP amount was reasonable. ALJ Decision at 12-25. Tri-County appealed all the Findings of Fact and Conclusions of Law (FFCLs) in the ALJ Decision. Request for Review at 1. Tri-County argued that the ALJ erred in assigning the burden of proof and committed other legal and procedural errors, and also challenged the ALJ's factual findings as unsupported. For the reasons explained fully below, we conclude that Tri-County has shown no error of law in the ALJ Decision and that the ALJ's FFCLs A.1, A.2, A.4, A.5, B, and C are supported by substantial evidence in the record as a whole. We find that FFCL A.3 is not supported by substantial evidence in the record as a whole. Consequently, we affirm the ALJ Decision, except as to FFCL A.3 which we reverse. We further conclude that the findings of noncompliance which we have upheld justify the CMP amount imposed by the ALJ.

Applicable Legal Standards

Based on a survey's findings, surveyors prepare a Statement of Deficiencies (SOD) which identifies and describes each failure to meet a participation requirement (deficiency) under a separate "tag" number. A remedy may be imposed against a facility that is not in "substantial compliance" with one or more participation requirements. 42 C.F.R. � 488.408(d). A facility is not in "substantial compliance" with a participation requirement if it is found to have a deficiency that results in actual harm to a resident or poses a risk of more than minimal harm to resident health and safety. 42 C.F.R. � 488.301. Surveyors assign a letter rating to the deficiency findings for each tag to indicate the scope and severity of the noncompliance found. State Operations Manual � 7400E.1.

The seriousness of deficiencies is assessed on a scale that considers scope (whether the deficiency is isolated or widespread) and severity (how great a harm - or potential for harm - is presented by the deficiency). 42 C.F.R. � 488.404. The most serious level of noncompliance is "immediate jeopardy," which is defined 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.

A CMP in the range of $3,050-$10,000 per day of noncompliance may be imposed for a deficiency that poses immediate jeopardy. 42 C.F.R. � 488.438(a)(1)(i). A CMP in the range of $50-$3,000 per day may be imposed for one or more deficiencies that do not constitute immediate jeopardy but that either cause actual harm or create the potential for more than minimal harm. 42 C.F.R. � 488.438(a) (1)(ii). Under 42 C.F.R. Part 498, a facility has a right to request a hearing by an ALJ assigned to the Departmental Appeals Board and a right to request review of an ALJ decision by the Board itself.

Standard of Review

The standard of review on a disputed issue of law is whether the ALJ decision is erroneous. The standard of review on a disputed factual issue is whether the ALJ decision is supported by substantial evidence in the record as a whole. Guidelines for Appellate Review of Decisions of Administrative Law Judges Affecting a Provider's Participation in the Medicare and Medicaid Programs; see, e.g., Fairfax Nursing Home, Inc., DAB No. 1794 (2001), aff'd, Fairfax Nursing Home v. Dep't of Health & Human Srvcs., 300 F.3d 835 (7th Cir. 2002), cert. denied, 2003 WL 98478 (Jan. 13, 2003).

1. The ALJ did not err in allocating the burden of proof.

The ALJ relied on a long line of Board decisions articulating the correct allocation of the burden of proof in cases where providers seek to demonstrate their substantial compliance with participation requirements in order to preclude imposition of sanctions resulting from findings of noncompliance. ALJ Decision at 4, citing Hillman Rehabilitation Center, DAB No. 1611 (1997), aff'd, Hillman Rehabilitation Center v. U.S. Dep't of Health and Human Srvcs., No. 98-3789 (GEB), slip op. at 25 (D. N.J., May 13, 1999); see also Cross Creek Health Care Center, DAB No. 1665 (1998) (extending analysis to CMP cases). The approach was recently summarized as follows:

CMS must come forward with sufficient evidence on disputed facts that together with the undisputed facts will establish a prima facie case that the facility is not complying with one or more participation requirements. The facility may rebut a prima facie case of noncompliance by showing, by a preponderance of the evidence, that it is in substantial compliance with participation requirements. Once CMS has established a prima facie case, the provider may then offer evidence in rebuttal, both by attacking the factual underpinnings on which CMS relied and by offering evidence in support of its own affirmative arguments. An effective rebuttal of CMS's prima facie case would mean that at the close of the evidence the provider had shown that the facts on which its case depended (that is, for which it had the burden of proof) were supported by a preponderance of the evidence. See Ross Healthcare Center, DAB No. 1896 (2003); Batavia [Nursing and Convalescent Center], DAB No. 1904; cf., Hillman Rehabilitation Center, DAB Nos. 1611 (1997), and 1663 (1998); aff'd, Hillman Rehabilitation Center v. United States, No. 98-3789(GEB) (D.N.J., May 13, 1999).

Western Care Management Corporation, d/b/a Rehab Specialities Inn, DAB No. 1921 (2004).

Tri-County argued that the Supreme Court has interpreted the Administrative Procedure Act (APA) to require "the proponent of the rule or order" to bear the burden of proving its case by the preponderance of the evidence. Tri-County Br. at 3-4, citing 5 U.S.C. � 556 and Steadman v. SEC, 450 U.S. 91, 102 (1981). Furthermore, Tri-County contended that the proponent of the order here must be considered to be CMS, so that the analysis in Hillman amounted to a administrative burden-shifting rule like that struck down in Office of Worker's Comp. Programs v. Greenwich Colleries, 512 U.S. 267, 281 (1994). Tri-County Br. at 4. Tri-County gave two bases for its conclusion that CMS must be the proponent here. First, Tri-County asserted that CMS was "the proponent of the rules set forth in 42 C.F.R. subpart 483." Id. at 3. Second, Tri-County argued that the government is the "proponent" when it seeks "to impose a fine or sanction," and that the CMP here falls into the same category. Id. In addition, Tri-County contended that the allocation of the burden of proof explained in Hillman should have been promulgated through notice and comment rulemaking either because it is a "substantive rule" under the APA or because Medicare law required CMS to formally adopt all rules going to the "nature and extent of the proofs and evidence." ⁽¹⁾ Tri-County Br. at 5-6, citing, inter alia, 5 U.S.C. � 553(b) and (c) and 42 U.S.C. � 405(a).

These arguments have been raised and rejected repeatedly in prior Board cases. We adopt by reference the thorough analysis set out in those decisions explaining why the burden of proof is properly assigned in CMP cases as it was by the ALJ here. See Omni Manor Nursing Home, DAB No. 1920 (2004); Batavia Nursing and Convalescent Center, DAB No. 1904, at 8-21, 24-27 (2004) (Batavia I); Batavia Nursing and Convalescent Inn, DAB No. 1911, at 8-22, 24-27 (2004)(Batavia II), and other cases cited therein.

In any case, we find that the allocation of the burden of proof is immaterial to the outcome of the present case. The applicable preponderance of the evidence standard prescribes the outcome when the evidence in the record on a particular issue is in equipoise. Meadow Wood Nursing Home, DAB No. 1841, at 6-7 (2002), aff'd, Meadow Wood Nursing Home v. Dept. of Health and Human Services, No. 02-4115 (6th Cir., Mar. 2, 2004); Fairfax, supra. Where either party presented evidence making it more likely than not that a contention is true, that party prevails on that issue. When neither has succeeded in establishing its contention as the more likely, then the party with burden of proof loses.

As is evident in our discussion below of the evidence as to the specific allegations, the evidence supporting the ALJ's conclusion that Tri-County was not in substantial compliance was more than sufficient to establish that contention by the preponderance of the evidence. Hence, regardless of which party bore the burden of proof, CMS would prevail here.

2. The ALJ did not adopt a strict liability standard.

Tri-County argued that the ALJ appeared to take "the position that a provider's staff must at all times deliver the highest possible standard of medical care and services to an individual who is without the desire or ability to reject that care or react adversely or even have changes in their physiological condition." Tri-County Br. at 7. This position was erroneous, according to Tri-County, because the regulations require only that a facility "be in substantial compliance with a requirement that the highest practicable care and services be delivered." Id. at 7 (emphasis in original; citation omitted). In particular, Tri-County argued that this standard incorporates a resident's right to refuse care. Id. at 7-8.

The position set out by Tri-County is cryptic, and tracks almost verbatim an argument counsel put forward in prior cases in which the Board noted that it was puzzling and lacked coherence. Batavia II at 4. None of the residents here were alleged to have sought to refuse proffered care or to have been unable to benefit from care to the extent that this argument somehow suggests that any relevant issue was raised to that effect. In any case, our overview of the ALJ Decision provides no support to any theory that the ALJ imposed an expectation of continuous perfection inconsistent with the regulatory standards. None of the allegations addressed in Tri-County's brief involved a question of whether a resident refused care or whether the facility should have overridden such a refusal. The allegations involved whether the facility failed to assess the need for and to take measures to avoid a foreseeable risk of harm from a gap between residents' mattresses and side rails, whether the facility failed to investigate the cause of an unexplained fracture, whether the facility failed to implement steps included in the care plan and physician orders to prevent the development of an avoidable pressure sore or to treat existing sores, and whether the facility failed to provide appropriate toileting services to an incontinent resident. It is evident on the face of the allegations (leaving aside what the evidence established about the underlying facts) that the standards against which the facility was measured are couched in terms of providing necessary and appropriate services to prevent avoidable harm and forestall foreseeable risks, not in terms of punishing a facility for any deterioration in a resident's status or medical condition however impossible to prevent.

The deficiency finding in regard to which Tri-County appeared to elaborate on this general claim of improperly high standards was the first tag, relating to accident prevention, the factual disputes relating to which are discussed later in this decision. Tri-County asserted that the ALJ could have upheld this deficiency only if he applied a "strict liability" rule. Tri-County Br. at 13. This argument is another one that has been repeatedly rejected by both the Board and by the courts. Woodstock Care Center, DAB No. 1726, at 25 (2000), aff'd, Woodstock Care Ctr. v. Thompson, No. 01-3889 (6th Cir. 2003); see also Josephine Sunset Home, DAB No. 1908 (2004); Cherrywood Nursing and Living Center, DAB No. 1845 (2002); Asbury Care Center at Johnson City, DAB No. 1815 (2002); Koester Pavilion, DAB No. 1750, at 25-26 (2000). The consistent conclusion of all these cases is that the statute and regulations hold facilities to meeting their commitments to provide care and services in accordance with the high standards to which they agreed but do not impose strict liability, i.e., they do not punish facilities for unavoidable negative outcomes or untoward events that could not reasonably have been foreseen and forestalled.

Tri-County ignored all this jurisprudence and instead cited only to two ALJ decisions which it described as "illogical," as follows:

This requirement [of adequate supervision and assistance devices to prevent accidents] does not amount to strict liability or require absolute success in an obviously difficult task. Using an outcome-oriented approach, facilities have flexibility to use a variety of methods and approaches, but they are responsible for achieving the required results.

The DAB may state all it wishes that this is not a standard of strict liability, but the clear reading of the words establishes that it is. The fact that an "outcome-oriented" approach is to be used means that if an accident happens, the facility has not "achieved the required result" the rule stipulates of preventing the unpreventable accident.

Tri-County Br. at 13, quoting Autumn Care of Norfolk, DAB CR1107 (2003) (insertion in brief) and citing Wellington Specialty Care, DAB CR548 (1998).

The concept of focusing on ends rather than means, that is, the outcome-oriented approach, did not arise from Board decisions but from congressional and regulatory approaches. As the Board explained in Koester Pavilion, "the law and regulations are designed 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. DAB No. 1750, at 25-26, citing Woodstock, DAB No. 1726, at 28-29 (which provides a full discussion of the relevant legislative and regulatory history). In this context, the reference to "outcome-oriented" does not imply that a bad outcome inevitably compels a deficiency finding, but rather that a facility that achieves the regulatory standards by means of novel approaches is not penalized. Furthermore, the outcome stipulated by the rule does not include "preventing the unpreventable accident," but rather taking practicable measures to prevent accidents that are reasonably foreseeable and preventable.

CMS explained in the preamble to the participation requirement regulations that its concept of "substantial compliance" was intended to meet statutory requirements for the protection of residents' needs for quality care, as follows:

We have defined "substantial compliance" as a degree of compliance such that any existing deficiencies have not caused actual harm and do not create the potential for more than minimal harm to a resident. This definition is consistent with the statutory focus on resident outcomes as opposed to procedural requirements that do not always accurately measure whether quality care is being furnished. Although an SNF or NF that falls short of total compliance may escape imposition of a remedy, it still has a duty to provide, to each resident, care that enhances the chances of positive outcomes and avoids negative outcomes. If a single resident experiences any harm, the facility has not satisfied its statutory obligations. Given the statute's focus on each resident's right to receive quality care, and the facility's obligation to provide it, we could not adopt a less rigorous standard of compliance.

62 Fed. Reg. 43,931, at 43,932 (Aug. 18, 1997)

Tri-County spent much energy in its discussion attacking the Board's supposed sub silencio adoption of strict liability and contrasting it with the claim that "tort principles of foreseeability and causation" must apply. Tri-County Reply Br. at 5. Tri-County's mischaracterization of Board decisions makes the first prong of this comparison misleading, as discussed above. The second prong is equally ill-conceived. Tri-County suggested that it would somehow be "inappropriate to conclude that the regulations impose a higher standard than that imposed by common law," and relied for this proposition on Ohio jury instructions which read as follows: "A person may be required by law to do something or not to do something. Failure to do what is required by law is negligence, as is doing something the law prohibits." Id. at 5, citing attached Ohio Jury Instructions 7.10.

The jury instructions reference a well-known legal principle which holds that an action or omission that would not otherwise constitute negligence can be the basis of tort liability if done (or left undone) in violation of law. The effect of this principle is precisely the opposite of that for which Tri-County cites it. Applying it to the current situation would raise the question (not relevant or resolvable before us) of whether Tri-County's violations of federal requirements might create negligence liability under Ohio state law, but certainly does not constrain federal requirements to remain at or below the standard for Ohio negligence torts. An Ohio judge explained this as follows: "Comprehensively stated, the rule is that where a legislative enactment imposes upon any person a specific duty for the protection of others, and his failure to perform that duty proximately results in injury to another, he is liable per se or as a matter of law to such other for the injury. . . . The violation of any specific legislative enactment enacted for the protection of private persons is of itself such a breach of duty as to constitute negligence." Eisenhuth v. Moneyhon, 161 Ohio State 367, 371, 119 N.E.2d 440 (Ohio S.Ct. 1954) (citations omitted). ⁽²⁾ This is so because "when an act is forbidden by express provisions of law, an absolute standard of conduct is set up, and one who commits the prohibited act resulting in injury will be deemed to be liable regardless of whether the injury might have been foreseen by a reasonably prudent person." Id. at 372.

Elements of reasonableness and foreseeability in evaluating facilities' measures to prevent accidents that are set out in the Board and court decisions cited above do not arise from state tort law but from the terms of the federal regulations themselves. For these reasons, the state tort cases discussed at length by Tri-County are not controlling here, but strikingly much of the cited case law would not support Tri-County in any case. For example, Tri-County itself noted that Ohio state courts have held that even where an injured party's own act caused the injury, liability may result where there is a special relationship or duty owed depending on the "degree of control" that "the tortfeasor can exercise over that party." Tri-County Reply Br. at 8, citing Estates of Morgan v. Fairfield Family Counseling Ctr., 77 Ohio St. 3d 284 (1997). It is difficult to conceive of a greater degree of control than that of a nursing facility over a resident heavily dependent on the staff in most aspects of life and care.

Tri-County also relied on a Mississippi case which held that the duty of care extends to injuries that are "reasonably foreseeable" and concluded that a nursing home could not reasonably have foreseen that a resident might die in her bed by fire ant bites. Tri-County Reply Br. at 6, quoting F. Joseph Rein, St. v. Benchmark Const. Co., No. 2001-CA-01885, slip op. at 28 (Miss. Ct. App., June 12, 2003). The decision cited by Tri-County was withdrawn by the court, however, and the final decision made clear that even tort law extends responsibility well beyond requiring complete predictability of harm, holding that "[w]hen the conduct of the actor is a substantial factor in bringing about harm to another then, 'the fact that the actor neither foresaw nor should have foreseen the extent of the harm or the manner in which it occurred does not prevent him from being liable.' Restatement (Second) of Torts, � 435 (1965)." Rein v. Benchmark Const. Co., 865 So.2d 1134, at 1144 (Miss. Ct. App. 2004). The Court further held that defendants "cannot escape liability because a particular injury could not be foreseen, if some injury ought to have been reasonably anticipated." Id. at 1145 (citation omitted).

Tri-County also addressed in detail a federal case from the Southern District of Ohio involving the death of a nursing home resident whose placement was assisted by the Veteran's Administration (VA) and who fell from the fire escape outside his window. Estate of Jaycox v. Setty Family Veterans Residential Care Home, 231 F.Supp.2d 725 (S.D. Ohio, 2002). His estate sued the home and the VA for wrongful death under the Federal Torts Claim Act, which incorporates state tort standards. The court found that Ohio state law did not impose a duty on the consulting social worker, while recognizing that a group home owed each resident "a heightened duty depending upon the nature of their impairments and the foreseeable consequences of those impairments in the residential setting at issue." Id. at 729-30, 33. The resident involved was determined to have been competent to make the decision to take a second-floor room and to appreciate the hazards of access to a fire escape/balcony, and hence no liability arose from his placement. Id. at 729-33. The court specifically cited governing law that an event may be foreseeable even where the actual nature of the event or injury could not be predicted. Id. at 731, and cases cited there. In any case, while this decision may provide "the applicable standard to review foreseeability in relation to a facility resident" in a case under Ohio tort law, it provides no standard to review compliance with applicable federal participation requirements. Cf. Tri-County Reply Br. at 6. The duty arising from the relationship between a facility accepting Medicare payment for its care and services and a resident of that facility is defined by federal law and regulations, and has been elucidated in numerous prior Board cases.

Noncompliance with those requirements results in consequences designed to protect residents and to motivate a return to substantial compliance. ⁽³⁾ See, e.g., 42 C.F.R. � 488.402(a). The consequences may include producing an acceptable plan to correct the deficiencies, termination of the facility's participation in the federal programs, civil monetary penalties, and many alternative remedies, depending on various factors set out in the regulations. 42 C.F.R. �� 488.404, 488.408. Tri-County complained that the "outcome-oriented" approach of the federal standards "ignores the element of culpability." Tri-County Reply Br. at 5. Culpability of the facility is, however, one factor to be considered in setting the amount of a CMP. 42 C.F.R. � 488.438(f)(4). Moreover, the focus on imposing incentives on noncompliant facilities to seek practicable methods of achieving the required goals of resident safety and quality care is entirely appropriate to a scheme that is remedial rather than punitive.

3. The ALJ's role properly included weighing the evidence and evaluating the credibility of witnesses in the first instance.

Tri-County complained generally that the ALJ "used only selective portions" of facility records, instead of viewing them "in their totality." Tri-County Br. at 7. Also, Tri-County criticized the ALJ for not finding that the cross-examination of CMS witnesses showed that "their observations are not based on an accurate review of the residents, their records, nor reflective of overall course of care and treatment to the observed residents." Id.

As noted, our standard of review is to look at the totality of the record in ascertaining whether the ALJ's findings are supported by substantial evidence. This standard requires us to consider not only the evidence relied on by the ALJ but the evidence cited by the petitioner as conflicting with or undermining those findings. We perform this review as to the individual findings below.

In response to the general arguments of Tri-County, however, we note that the ALJ is entitled to determine how much weight to give to evidence in the record and to evaluate the testimony of witnesses in the first instance. The mere fact that the ALJ may not have accepted Tri-County's characterization of the contents of medical records or Tri-County's view of the effect of its cross-examination does not suffice to show error. We do not see any basis for Tri-County's implication that the ALJ did not consider evidence presented by Tri-County simply because the ALJ ultimately did not credit that evidence in some instances.

4. We sustain the ALJ's conclusions that Tri-County failed to meet the requirements of 42 C.F.R. � 483.25(h)(2) (Tag F324) and that the CMS immediate jeopardy determination for this deficiency was not clearly erroneous.

Among the requirements which a facility must meet to participate in the Medicare program are standards for quality of care in preventing accidents which provide as follows:

Each resident must receive and the facility must provide the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the comprehensive assessment and plan of care.

* * *

(h) Accidents. The facility must ensure that -

* * *

(2) Each resident receives adequate supervision and assistance devices to prevent accidents.

42 C.F.R. � 483.25(h)(2) (emphasis in original).

The SOD reported findings of noncompliance with this requirement relating to three residents. The ALJ concluded that the allegations of a violation that created a situation of immediate jeopardy in regard to one resident, Resident 116, were well-founded and unrebutted. ⁽⁴⁾ It is not disputed that Resident 116 was found dead at 2:10 AM on April 15, 2000, with his head between the side rail and the mattress. ALJ Decision at 6. The parties did dispute the resident's history and condition prior to the incident in terms of whether the facility should have assessed Resident 116 as in danger of entrapment with the use of unpadded side rails. A dispute also existed as to whether the resident's death was caused by entrapment or whether he may have died of other causes and then fallen over the side rails.

Before us, Tri-County contended that Resident 116 "did not present as at risk for entrapment in any manner" and that he "was not demented, enfeebled or incapable." Tri-County Br. at 9. Tri-County pointed to testimony that the resident would ask for assistance if he needed it and asserted that he was "full weight bearing." Id. at 11, citing Tr. at 224-25.

According to the SOD, Resident 116 was initially admitted to Tri-County on February 25, 2000, with diagnoses including syncope, dehydration, and anemia. See ALJ Decision at 6, and record citations therein for more detail. He had a physician's order for use of side rails for bed mobility and transfer. He was assessed as being incontinent, needing physical assistance with all care, and being at risk for falls but not shown as at risk for entrapment. The resident was hospitalized for pneumonia and other acute diagnoses on March 19, 2000 and readmitted on March 27, 2000. On April 8, 2000, the resident was found on the floor near his bed and sent to the hospital where a hip fracture was surgically repaired. He returned on April 12, 2000. No new assessments or interventions were noted regarding the risk of entrapment with the continued use of the side rails. The resident died on April 15, 2000, about 40 minutes after the last nursing notes recorded observing him in bed and confused despite unsuccessful attempts to reorient him.

The ALJ rejected Tri-County's claims that the resident had improved greatly after his return from the hospital and that no changes to his care were determined to be necessary because he was alert, oriented, able to follow directions, and fully weight-bearing. ALJ Decision at 8. The ALJ noted that Tri-County failed to identify hospital records that purportedly showed that "this 93-year-old resident was full weight bearing two or three days after undergoing hip replacement," but emphasized that, even were that claim true, the change in status from the fall and from the surgery should have called for a reassessment of the risk for entrapment in using unpadded side rails. ALJ Decision at 8-9. The ALJ found the testimony of Tri-County's current Director of Nursing (DON), Patricia Berling, that Resident 116 had improved ambulation skills to be unsupported by the records cited (it was not based on firsthand knowledge since she was not at the facility at the time of his death). ALJ Decision at 8-9. The ALJ credited the surveyor's report that the staff who cared for the resident told her that he was not able to get up independently before or after the hip fracture and that he was confused and required total care when he returned from the hospital the second time. Id. The ALJ accepted the surveyor's report that the nursing supervisor told her during the survey that the resident was "debilitated" and showed "significant decline in his abilities" and more dependence and confusion. Tr. at 30. Such credibility determinations are appropriately vested in the decision-maker who observed these witnesses firsthand, and Tri-County has shown no reason for us to overturn them.

As the ALJ noted, the testimony he credited is more consistent with the facility's own records on the resident's history of multiple diagnoses and dependence on the staff. ALJ Decision at 9-10 and record citations therein. The resident's care plan at admission called for a staff person to assist with mobility, transfers, and self-care due to generalized weakness and identified the resident's potential for falls. P. Ex. 4, at 3. The fall on April 8, 2000, was apparently the result of the resident trying to get out of bed independently to go to the bathroom, which undercuts the assertion that he could be relied on to ask for assistance when needed. See P. Ex. 4, at 18; ALJ Decision at 10. At the time of his last admission, Resident 116 weighed only 109.9 lbs. P. Ex. 4, at 42. The nursing notes before his fall do often describe the resident as alert and cooperative, but the notes after his return refer to confusion. See id. passim.

Tri-County also argued on appeal that the cause of Resident 116's death was unknown. Tri-County described the resident as having "expired slumped over his bed rail with his feet on the floor and his head and shoulders hanging down over the interior side of the bed rail in such a manner that his head rested between the mattress and the rails." Tri-County Br. at 9. Tri-County argued that the resident could not have become wedged in the gap and somehow flipped his body over the side without a struggle that would draw the attention of nearby staff. Id. at 11-12. Instead, Tri-County suggested that the resident more likely was standing and suffered a syncope or cardiac event and fell into the position in which he was found. Id. at 14-16. Tri-County cited no evidence or testimony whatsoever in support of its speculation about an alternative cause of death. Tri-County emphasized, however, that the coroner's finding that the resident died of suffocation and asphyxiation was merely "preliminary," because no proper autopsy could ultimately be conducted because the body had been sent to the funeral home and embalmed prior to the coroner having access to it. Id. at 12. CMS responded that Tri-County presented no evidence that the coroner was not able to do a proper examination to support his conclusions because of the embalming. ⁽⁵⁾ CMS Br. at 30. We need not resolve this dispute. The fact that the resident's head was trapped between the mattress and the side rail demonstrates that a gap was permitted to exist that was large enough for the resident to be wedged into, regardless of whether the death was caused by the entrapment or occurred before the resident fell into the position. Given the ALJ's findings as to the vulnerability of this resident, a gap of this magnitude clearly presented a foreseeable risk for entrapment.

We conclude that substantial evidence in the record viewed as a whole supports the ALJ's finding that the facility should have recognized that this resident was at risk for entrapment when using side rails and should therefore have taken appropriate steps to protect him. Prior Board decisions have discussed in detail the dangers that entrapment resulting from gaps between side rails and mattresses presents for infirm, frail, confused individuals in nursing facilities. See, e.g., Meadow Wood Nursing Home, supra.; Good Samaritan Center, DAB No. 1844 (2002). While there was conflicting evidence here on the resident's condition and risk status, the ALJ properly considered and weighed the evidence before him. Tri-County has presented no persuasive reason to disturb the ALJ's conclusion that "[g]iven the fact that the resident was physically and mentally so compromised that he would be unable to extricate himself from a life threatening situation, the facility was derelict in not taking measures that were adequate to prevent an accident." ALJ Decision at 10.

Tri-County further contended, however, that CMS had failed to demonstrate that practicable means existed to address any entrapment risk that may have existed. Tri-County first pointed out that the surveyor agreed that the use of side rails for bed mobility was appropriate for this resident's use. Tri-County Reply Br. at 2, citing Tr. at 45. The surveyor's actual testimony makes plain a distinction between the appropriateness of using the side rails and the importance of addressing the concurrent hazards raised by their use. Thus, asked about the use of the side rails, she explained:

Well, they were used for bed mobility. But they were increasing his risk for side-rail entrapment because they were creating two different things. Yes, they were used for bed mobility and not inappropriate. But because of the gap between the side-rail and the mattress, then you have a safety hazard of risk that's inherent with the use of those that you need to eliminate if you're going to continue to use those side-rails.

Tr. at 45. The two alternatives discussed during the proceedings below were the use of side-rail padding or the insertion of some material (such as foam swimming noodles or pillows) to fill the gap. Tri-County argued that padding would make the side rails unusable for their purpose of promoting independent mobility in bed and that the swimming noodles might not meet fire safety standards for use in nursing facilities. Tri-County Br. at 12; Tr. at 223. The ALJ found this concern to be unfounded and merely an "after-the-fact attempt [by the DON] to legitimize" the facility's failure to provide appropriate assistance devices. ALJ Decision at 10, n.4. The ALJ gave more credence to the testimony of the surveyor that the padding is made to go through the bars of the side rail such that it can still be used for mobility. Id., citing Tr. at 45. As far as the use of swimming noodles, the ALJ pointed out that there was again no documentation that the facility actually considered and rejected this option based on fire safety, and that in any case the surveyor merely listed this as one possible material to fill in the gap. ALJ Decision at 10-11, n.5, and 14. The responsibility rested on the facility to select appropriate devices. Id., at 10-11, n.5, citing Tr. at 181.

Tri-County alleged, finally, that the surveyors told Tri-County that they "had to write an immediate jeopardy citation" because "a resident died due to an accident." Tri-County Br. at 12. The brief does not elaborate on this assertion except to cite to testimony from Tri-County's administrator, Richard Barasch, who reported the following exchange with the surveyor:

I did speak with Ms. Truett a number of times. It was a very disturbing situation for all of us. We met at one point in our conference room and I was going over what I had learned. In the course of that, she did look at me and say -- I said, you know, there are lots of possible explanations as to what could have happened there. I wasn't there. You weren't there. We don't know exactly what happened.

And she said: Well, Rich, the man died. So, I have to do something.

Q. What did you understand that something to be?

A. That she had to -- she felt obligated to cite us because the individual did die.

Q. The immediate jeopardy citation?

A. Yes.

Tr. at 251. While Mr. Barasch may have interpreted the surveyor's statement to mean that a citation at the immediate jeopardy level would be written whether justified or not, the surveyor's remarks, even as he reported them, do not compel any such conclusion. The surveyor was asked on cross-examination whether she told Mr. Barasch that she "had to issue a jeopardy citation" because there had been a death. Tr. at 160. She indicated that she did tell him that an immediate jeopardy situation was identified but did not agree that she used words to the effect that a citation had to issue because of the death alone. Id. The discussion at issue took place during the exit conference, after the surveyor had already gathered the facts relating to the resident's death, so that she was as likely to be referring to the need to take action under all the circumstances as she saw them.

Certainly, the surveyor discussed at length in her testimony the reasons she determined that the resident should have been assessed as at risk for entrapment and should have been provided with adequate devices to prevent entrapment, so it is clear she did not believe that the fact of death per se established that the cited regulation was violated. See Tr. at 20-52. We do not accept the implication suggested by Tri-County that the surveyor's reported remarks to Mr. Barasch demonstrate some pre-existing intention to find immediate jeopardy without regard to the factual findings.

Nor are we persuaded that the ALJ "engaged in ipsedixitism" by equating an accident with proof of noncompliance. Tri-County Resp. to CMS Surreply Br. at 3. On the contrary, the ALJ set out an analysis based on the existence of foreseeable risk resulting from the resident's condition and the use of side rails and of available reasonable measures to address the risk yet left undone. The fatal accident vividly illustrates the scope of the harm that could result from the failure to take adequate measures to prevent entrapment, since it may have been the cause of the death (even if there were other possible causes), but did not in itself prove the noncompliance.

Furthermore, as the ALJ pointed out, Tri-County's assertion that the death may have followed a sycoptic episode, if anything, adds to the red flags which should have alerted the facility to protect the resident from entrapment. ALJ Decision at 23. The facility was aware that the resident suffered from congestive heart failure and from syncope which could cause unconsciousness without warning in a resident who had already fallen while trying to climb out of bed without assistance. These circumstances surely emphasized the seriousness of the risk to this resident that he might be unable to extricate himself or call for help if trapped. The ALJ correctly focused in finding immediate jeopardy not only on the finding that Resident 116 most likely died of strangulation by entrapment, but also on the finding that similar side rails were still in use after the entrapment of Resident 116. He therefore concluded that others, such as Resident 105 and Resident 108 who were also shown to be at risk of entrapment, "were likely to suffer serious injury, harm, impairment or death." ALJ Decision at 24.

We conclude that the ALJ's determination that Tri-County failed to comply substantially with the requirements cited under Tab F324 was free from legal error and supported by substantial evidence on the record as a whole. In addition, we agree with the ALJ's conclusion that CMS's immediate jeopardy determination was not clearly erroneous.

5. Substantial evidence supported the ALJ's conclusion that Tri-County failed to meet the requirements of 42 C.F.R. � 483.13(c) (Tag F225).

The allegations regarding this tag arose from a hip fracture suffered by Resident 113. On April 14, 2000, nurses documented at 11 AM and 6 PM that the resident complained of severe pain when attempts were made to straighten her left leg which was rotated outward. ALJ Decision at 12, and record citations therein. The resident had a long history of repeated falls, and stated that she had fallen out of bed the previous day. ⁽⁶⁾ She had been re-admitted to the facility on April 13, 2002, after a hospitalization for dehydration, and no range of motion problem was found on a full physical assessment at 1:05 PM that day. The ALJ therefore inferred that the fracture occurred between 1:05 PM on April 13, 2000, and 11 AM on April 14, 2000. Id. at 12, n.7; see P. Ex. 2 at 46-47.

The cited regulation addresses staff treatment of residents, requiring policies to prohibit mistreatment, neglect, and abuse; prohibiting use of abuse, punishment, or involuntary seclusion; barring employment of individuals with a record of abuse; and imposing a duty to investigate all alleged violations. 42 C.F.R. � 483.13(c). The regulation specifically requires that the facility must ensure that all "injuries of unknown origin" are reported to the administrator and state officials and thoroughly investigated.

The resident had a medical history that included osteoporosis and past compression fractures of her spine. P. Ex. 2, at 69A-69C. Tri-County argued that, given this history and the absence of visible trauma to the area, no investigation was warranted because the origin of the injury could be inferred to be a spontaneous fracture related to her diagnoses. Tri-County Br. at 17-18. ⁽⁷⁾ Thus, Tri-County concluded that it was "foolish for the ALJ to find a failure to document where no requirement to document existed" because "there was no abuse and this was not an injury of unknown origin." Id. at 18.

We disagree. The ALJ rejected this argument as speculation three years after the fact, because no evidence was presented that Tri-County even contacted a medical doctor at the time to verify the cause of the hip injury. ALJ Decision at 4. Given that the resident also had a long history of falls, including a fall three months earlier in which she fractured her left hip, the facility clearly could not necessarily assume that the hip fracture was spontaneous. The ALJ was entitled to conclude that the retrospective testimony of the DON was an insufficient basis to support that assumption.

6. The ALJ's conclusion that Tri-County failed to meet the requirements of 42 C.F.R. � 483.13(c)(F272) is not supported by substantial evidence on the record as a whole.

This deficiency relates to the regulatory requirement that facilities make comprehensive assessments of the needs of each resident. The ALJ concluded that Tri-County had failed to comply by not assessing the safety issues and risk factors related to the use of side rails by Residents 105 and 108, the other two residents who were cited (but not discussed in detail by the ALJ) in relation to Tag F324. ALJ Decision at 15.

Tri-County argued that it completed comprehensive assessments of the residents within the time limit set in the regulations. The ALJ, however, noted that CMS did not cite Tri-County for failure to perform timely comprehensive assessments, but rather for failure to identify and assess the residents' risk of side-rail entrapment. ALJ Decision at 15. Both residents had experienced apparent falls and been found next to their beds or found trying to climb out of bed on at least two occasions. Id. at 14. The ALJ found that the facility had assessed both residents as at risk for falls. Id. at 13-14. Nevertheless, the ALJ concluded that Tri-County had "not advanced any evidence that demonstrates that it made an assessment regarding these two residents' risk of side-rail entrapment." Id. at 15.

In fact, the record contains side-rail safety assessment forms for both residents. The ALJ did note a side-rail assessment form was completed for Resident 108 but stated that it did not identify entrapment as a risk. Id. at 14. The side-rail safety assessment form dated March 2, 2000 assesses side rails as indicated for this resident to "[a]llow increased bed mobility." CMS Ex. 26, at 7. The next section on the form provides a checklist of possible safety risks. Skin tears and abrasions were checked as possible risks with side-rail use for the resident, but no checks are in the boxes for going over the side rails, for bruises, or for entrapment as risks for this resident in using the side rails. Id. ⁽⁸⁾ The SOD asserted that the deficiency arose because the side-rail safety assessments for Resident 108 identified "no safety or entrapment risks," although clearly the document on its face did identify two safety risks. CMS Ex. 21, at 6. In addition, the March 2, 2000, care plan for Resident 108 notes the intervention of using side rails for mobility and plans for staff to "monitor for loose or broken side rails, need for gap fillers." CMS Ex. 26, at 12; Tr. at 57-58. This documentation suggests that the staff was aware of the need to keep a watchful eye on any gaps that might develop.

As to Resident 105, the SOD stated that this resident was not "comprehensively assessed for safety issues." Id. at 7. The resident's comprehensive assessment (dated April 14, 2000) identified risk of falls and noted that the resident was using side rails for bed mobility or transfers. P. Ex. 5, at 9. A side-rail assessment form for this resident showed checkmarks for skin tears, bruises, and abrasions. Id. at 43.

Ms. Berling, the nurse who completed both forms, testified that, when a box is not checked, it means that the risk was assessed but not found to be indicated for the resident. Tr. at 190-91. She testified that entrapment risk was uniformly assessed and that, when it was found, side rails were not used. Id. at 193. The ALJ made no finding that this testimony by Ms. Berling was not credible.

The SOD did not include any allegations regarding the existence or size of gaps between the side rails and mattresses. The surveyor testified that, at the time of the survey, she observed an unpadded gap between side rail and mattress for each of these two residents. Tr. at 60, 80. There was no testimony as to the size of the gaps involved or when they may have developed. The surveyor testified that Resident 108 was a "big guy" and Resident 105 was a "smaller-type man." Tr. at 61, 80. The surveyor opined, and the ALJ evidently agreed, that the gaps were such that the side rails without padding did not constitute adequate assistance devices for these residents. Tr. at 61-62, 80-81. This evidence, however, went to the deficiency which we have already upheld under Tag F324. It does not support CMS's allegation that the facility had made no comprehensive safety risk assessments relating to the use of side rails by these residents. ⁽⁹⁾

The issue here, as framed by CMS and the ALJ, turns on whether the facility failed to assess the risk of entrapment because the box for entrapment risk was not checked, or whether the form evidences that the facility did consider entrapment risk and affirmatively concluded that entrapment was not a risk for these residents with the use of side rails. Neither the ALJ nor CMS based this deficiency on the claim that the safety risks were considered but that this was not a comprehensive assessment since the facility concluded that entrapment risks were not present.

We therefore need not here decide whether in some circumstances an assessment that addresses all the relevant safety issues but comes to clearly erroneous or unsupportable conclusions about them may constitute a deficiency under this tag. We conclude more narrowly that a deficiency as to Residents 105 and 108 cannot be supported here on the asserted basis that no assessment occurred. First, the selective checking of risks on the forms is strong evidence that each listed risk was consciously considered. Second, the direct testimony of Ms. Berling that the risks were assessed as an intrinsic part of completing each of the forms was not rejected by the ALJ on credibility grounds or otherwise refuted.

We therefore reverse FFCL 3 of the ALJ Decision regarding Tab F272. ⁽¹⁰⁾

We further conclude that our reversal of this single tag does not require reassessment of the reasonableness of the amount of the $450 per day CMP. Tri-County's challenges to the amount of the CMP before us were premised on the claim that the facility should not have been found out of substantial compliance, as well as a reference that its survey history and financial condition made the amount unreasonable in any event. Tri-County Br. at 28. The ALJ found that Tri-County presented no evidence on its financial condition or other factors going to the amount of the CMP. ALJ Decision at 25. In upholding the amount, the ALJ emphasized the actual harm caused to one resident and the high culpability of the facility in relation to pressure sores and the "egregious" failures in regard to incontinence care. We uphold the ALJ's conclusions regarding these deficiencies in the following sections. The $450 per day amount is less than one sixth of the top amount available in situations not involving immediate jeopardy, i.e., $3,000 per day. Given the seriousness of the remaining deficiencies as highlighted by the ALJ, and the other factors discussed, the amount imposed remains reasonable.

7. Substantial evidence supported the ALJ's conclusion that Tri-County failed to meet the requirements of 42 C.F.R. � 483.25(c) (Tag F314).

The ALJ found that the facility allowed Resident 22 to develop an avoidable pressure sore and failed to ensure he received necessary care and services to promote healing of an existing pressure sore and to prevent infections and new pressure sores from developing. ALJ Decision at 15. The relevant regulatory requirement is as follows:

Based on a comprehensive assessment of a resident, the facility must ensure that -

(1) A resident who enters the facility without pressure sores does not develop pressure sores unless the individual's clinical condition demonstrates that they were unavoidable; and

(2) A resident having pressure sores receives necessary treatment and services to promote healing, prevent infection, and prevent new sores from developing.

42 C.F.R. � 483.25(c).

The surveyors found that Tri-County failed to comply with both prongs of this requirement in regard to Resident 22. CMS Ex. 21, at 7-10; ALJ Decision at 15-16. They found that Resident 22 had entered with a pressure sore area on her heel but none on her coccyx, and was assessed as at risk for skin breakdown due to incontinence, dependence on staff, and multiple medical problems. Id. A red area developed on the resident's coccyx on March 30, 2000, which progressed to an open area a week later. Id. The resident's physician ordered a therapeutic mattress and various medications. CMS Ex. 24, at 9. The facility planned interventions, including checking the resident's brief every two hours and as needed, and providing pericare whenever incontinence occurred. Id. at 25, 30. The resident's care plan also called for "meticulous skin care" and repositioning of the resident in her bed or chair at least every two hours, as well as applying medication as prescribed, providing adequate nutrition, monitoring carefully and using gentle touch to prevent skin damage. Id. at 30.

The surveyor testified that she observed Resident 22 on April 21, 2000, for more than three hours beginning at 7:10 AM during which the resident lay on her back in bed without a pressure relief mattress. Tr. at 117, 124-25, 129-31; see also CMS Ex. 21, at 9. The surveyor reported that the resident was crying out for help with incontinence care, that the resident's brief was visibly saturated with urine throughout the period, and the staff did not reposition her during this time. Tr. at 132; CMS Ex. 21, at 9. She also asserted that a nurse aide entered the room during that time and heard the pleas but left, promising to return and give care but not doing so. Further, the surveyor reported that the pressure sore was observed when the wet and soiled brief was removed and the dressing on it was not the kind ordered by the physician. CMS Ex. 21, at 10.

Tri-County argued before us that it had presented evidence that should have convinced the ALJ that it was in substantial compliance with the regulation. Tri-County Br. at 21-25. Most of the arguments were assertions of fact that the ALJ fully addressed and rejected in his decision. ALJ Decision at 16-19. Many of the factual claims themselves, even if Tri-County's version were accepted, would not alter the result. For example. Tri-County argued that Resident 22 had many diagnoses causing her to be at high risk of pressure sores, apparently suggesting this demonstrated that the development of new pressure sores was unavoidable. Tri-County Br. at 22-23. Tri-County also repeated its claim below that the coccyx sore had healed but re-opened during a hospital stay. Id. at 23-24; see also Tr. at 210, 243. Accepting that the resident was at very high risk of developing and worsening pressure sores only makes it more unacceptable that the facility ignored the primary interventions it planned to avoid and treat such sores - prompt toileting and skin care, regular repositioning to alleviate pressure, and use of a special mattress. Pressure sores cannot be said to be unavoidable simply because a resident's clinical condition creates susceptibility, if planned measures to minimize the risks are not implemented consistently. In the circumstances here, it makes little difference if the sore, which admittedly originated while the resident was in the facility, had once been healing and reopened in the hospital or whether the full course of its development occurred in the facility. It is clear regardless that measures were not implemented to prevent or treat the sore during the period while the resident was in the facility.

Many assertions by Tri-County recited things that were generally supposed to be done as if they were undertaken, without presenting any evidence that they actually occurred on the date on which the surveyor observed their absence. Tri-County Br. at 24. For example, Tri-County cited testimony of its current DON that nurses check all residents' briefs between 7 and 7:30 AM every day, and that many appropriate interventions were in place for this resident including a pressure relief mattress, repositioning every two hours, and toileting every four hours in a habit training program. Id. This DON had no personal knowledge of what occurred during the survey, and thus could not contradict the surveyor's testimony that she observed that the interventions were not in fact implemented. Furthermore, the care plan called for checking for incontinence every two hours. A training plan to take the individual to the toilet every four hours to encourage regular habits does not preclude checking more often for incontinence and providing immediate skin care. CMS Ex. 24, at 25, 30.

We conclude that the ALJ's finding on this tag was supported by substantial evidence in the record as a whole.

8. Substantial evidence supported the ALJ's conclusion that Tri-County failed to meet the requirements of 42 C.F.R. � 483.25(d)(2) (Tag F316).

The ALJ found that the facility failed to overcome CMS's evidence that two residents did not receive appropriate care to prevent urinary tract infections (UTIs) and to restore bladder function. ALJ Decision at 22. The relevant regulatory requirement on urinary incontinence is as follows:

A resident who is incontinent of bladder receives appropriate treatment and services to prevent urinary tract infections and to restore as much normal bladder function as possible.

42 C.F.R. � 483.25(d)(2).

The essential facts relating to Resident 22 were discussed in the preceding section. As to Resident 21, the surveyor reported that the resident did not receive incontinence care during the same period, even though a nurse aide transferred her to a wheelchair and fed her breakfast at 8:23 AM. CMS Ex. 21, at 11-12. The surveyor reported that the resident's brief at the time of transfer was falling off, heavily soaked with foul-smelling urine, and yet was not changed for almost two more hours. Id.

Tri-County presented testimony from the current DON disputing the events by asserting that an LPN who had been present at the time was "quite upset with the citation because she said that, in fact, the brief had been dry when they got her up." Tr. at 219-220. The ALJ found the hearsay testimony unreliable because the LPN would have had an interest in "salvaging her standing with her employer" and because Tri-County did not present the LPN as a witness (or explain why it could not). ALJ Decision at 22.

Tri-County also sought to undermine the credibility of the surveyor's observations by stressing her admission that she was away from the room which both residents shared for some period of time during the three-hour period in question. Tri-County Br. at 26. The surveyor testified that at some time prior to 7:22 AM she made a single walk of about 100 yards through the building. Tr. at 174. She also testified that she was never away from the residents' room "long enough for Tri-County staff members to enter without [her] noticing." Id. at 103. We see no reason to disturb the ALJ's conclusion that Ms. Truett's testimony was credible. ALJ Decision at 21.

Most of the arguments offered by Tri-County here have the same flaws as those addressed in the preceding section, such as treating the existence of an intervention in a care plan as proof that the intervention occurred, despite contrary first-hand observations. Tri-County also complained that nothing supported CMS's allegation that Resident 21 suffered from "chronic renal failure, urosepsis, and dehydration with a history of" UTIs, as the surveyor testified. Tri-County Br. at 25; Tr. at 99. This complaint ignores the ALJ's response to the same argument below by specifying where those conditions were recorded in the facility's own records. ALJ Decision at 21.

We conclude that the ALJ's finding on this tag was supported by substantial evidence in the record as a whole.

9. Tri-County's objections to the ALJ's evidentiary rulings or asserted hostility fail to establish any lack of due process or fair hearing.

Tri-County recounted twelve examples of rulings in which the surveyor, Ms. Truett, was permitted to answer questions or provide testimony despite objections from Tri-County's counsel. Tri-County Reply Br. at 11-12. Tri-County offered no argument as to why it believed the ALJ's individual rulings were in error or how an error as to any of these items of testimony prejudiced it. Generally, most of the testimony complained of consisted of the surveyor's expressing her opinion that the use of side rails without providing some measure to close the gaps showed a failure to provide adequate assistance devices and supervision to prevent accidents in the circumstances of the residents cited, that the entrapment risk should have been identified and addressed by resident assessments, and that the potential results of risking entrapment included serious harm and even death. Id., and transcript references cited therein. Tri-County counsel offered a continued objection to opinion testimony from the surveyor, to which CMS responded that the witness was qualified based on education, experience and training. Tr. at 47. The ALJ allowed a continuing objection, and made determinations in his decision as to the persuasiveness of conflicting opinions offered by the surveyor and the facility's current DON. See, e.g., ALJ Decision at 9-10. Ms. Truett's qualifications were placed in the record and subject to cross-examination. See Tr. at 14-19. It was within the ALJ's purview to determine that the subjects on which she was asked to opine were within her area of expertise and to give those opinions such weight as he found that they merited.

Tri-County's claim of hostility and bias by the ALJ arose from a procedural dispute that occurred at the hearing. Tri-County counsel reserved its cross-examination of CMS's witness, Ms. Truett, to call her as part of its presentation "as on cross-examination." Tr. at 135. After completing his cross-examination, Tri-County's counsel objected to the ALJ permitting any redirect examination by CMS explaining that the reason he reserved cross was to preclude any redirect since CMS has closed its case-in-chief. Tr. at 178-79. Counsel asserted that this strategy was successful at a hearing before another ALJ, although neither the colloquy at the hearing nor the briefing identified the case in which this maneuver was assertedly permitted. Tr. at 179. The ALJ decided to permit CMS to ask questions on redirect, noting counsel's exception. Tr. at 181. During the colloquy, counsel for Tri-County made the following remark: "Well, I try to look for consistency in appearing before the [DAB]." Tr. at 179. On appeal to us, Tri-County asserted that a response was made by the ALJ that does not appear in the record allegedly stating that "[t]here is no consistency in the conduct of these hearings." Tri-County Reply Br. at 12.

The Board has previously discussed the law governing challenges to ALJ decisions based on claims of bias and prejudice as follows:

In Edward J. Petrus, Jr., M.D., and The Eye Center of Austin, DAB No. 1264 at 23-26 (1991)[aff'd sub nom., Petrus v. I.G., 966 F.2d 675 (5^th Cir. 1992), cert. denied, 506 U.S. 1048 (1993)], the Board described the standard for disqualifying a judge on a charge of bias. The Supreme Court, the Board noted, has held that "[t]he alleged bias and prejudice, to be disqualifying, must stem from an extrajudicial source and result in an opinion on the merits on some other basis than what the judge learned from his participation in the case . . . ." United States v. Grinnell Corp., 384 U.S. 563, 583 (1966); see also Tynan v. United States, 376 F.2d 761 (D.C. Cir. 1967), cert. denied, 389 U.S. 845 (1967); Duffield v. Charleston Area Medical Center, 503 F.2d 512, 517 (4th Cir. 1974). Here, St. Anthony did not point to any extrajudicial source of bias. Rather, St. Anthony referred to the ALJ's rulings on the parties' motions, his alleged predisposition not to consider certain evidence, and allegations that the ALJ had taken positions on important issues prior to the presentation of all of the evidence. The ALJ's rulings, however, do not constitute a sufficient basis for showing bias. See Ex Parte American Steel Barrel Co. and Seaman, 230 U.S. 35 (1913); In Re International Business Machine Corp., 618 F.2d 923, 929 (2d Cir. 1980); see also Annotation, Disqualification of Federal Judge, 2 A.L.R. Fed. 917, at 927 (1969), noting: "It has been uniformly held or recognized in civil proceedings that adverse rulings made by the judge in the case or proceeding itself do not constitute a sufficient basis for his disqualification under the statute [pertaining to disqualifications of federal judges]."

St. Anthony Hospital, DAB No. 1728 (2000), aff'd, 309 F.3d 680 (10^th Cir. 2002). Here, as in St. Anthony, we find that a close examination of the entire record shows no foundation for Tri-County's accusations against the ALJ other than disappointment at the lack of success of a questionable procedural ploy and at the credence accorded unfavorable testimony. See also Meadow Wood, DAB No. 1841, at 10 (2002)("[W]eighing of testimony and evidence in the record is the essential task of an ALJ and can hardly be viewed as a demonstration of bias toward the party that does not prevail on the merits, however disappointed."), aff'd, slip op., Civ. No. 02-4115 (6^th Cir., March 2, 2004).

Particularly disturbing here is the manner in which counsel for Tri-County sought to present its accusation of an off-the-record comment by the ALJ during the hearing. The alleged comment itself would not necessarily imply any bias or hostility. The regulations provide the ALJ with authority to decide "the order in which the evidence and the arguments of the parties are presented and the conduct of the hearing." 42 C.F.R. � 498.60(b)(3). In the context of responding to a claim that another ALJ in another case permitted a procedural approach that he declined to allow in the present case, the ALJ could reasonably have remarked that the hearing procedures were not and need not always be the same in different cases. The remark that counsel now claims was made does not appear in the record, however, and counsel never asserted before the ALJ that the transcript was inaccurate or incomplete even though he was given an opportunity to note all prejudicial errors. Instead, counsel simply asserted now that he and his client heard the statement even if counsel for CMS did not. Tri-County Opposition to CMS Motion, at 2; see also Board Ruling on CMS Motion, dated March 15, 2004. This belated claim of an unrecorded statement by the ALJ detracts from, rather than adding to, the plausibility of Tri-County's assertions of ALJ bias or hostility.

We conclude based on careful review of the record that the bias arguments proffered by Tri-County are without any merit.

Conclusion

For the reasons explained fully above, we affirm the ALJ Decision except as to FFCL A.3 which we reverse.

RETURN RECEIPT REQUESTED March 15, 2004

Geoffrey E. Webster
Attorney at Law
Two Miranova Place, Suite 310
Columbus, Ohio 43215

and

James L. Reed, Jr.
Assistant Regional Counsel
DHHS - Region V
233 N. Michigan Avenue, Suite 700
Chicago, Illinois 60601-5519

Re: Tri-County Extended Care Center

Board Docket No. A-04-42

RULING ON CMS MOTION

Counsel:

The Centers for Medicare & Medicaid Services (CMS) filed a motion dated February 23, 2004 requesting that the Board either disregard certain portions of the reply brief submitted by Tri-County Extended Care Center (Tri-County) or, in the alternative, permit CMS to file a surreply. CMS based its motion on the contention that three issues were raised for the first time in Tri-County's reply brief. Tri-County responded by letter dated February 25, 2004, opposing the CMS motion.

As to the first two issues, what relevance the tort concepts of strict liability and foreseeability have in this context and whether the ALJ committed prejudicial procedural errors in overruling twelve objections offered by Tri-County's counsel at the hearing, Tri-County did refer to the same issues in its request for review. I therefore decline to strike or disregard the discussions in the reply. Since Tri-County's reply brief did expand and focus the discussion of these areas considerably, however, I will permit CMS a brief period in which to submit a surreply brief responding to the expanded arguments. CMS's surreply brief is due two weeks from its receipt of this ruling. If new material in that CMS surreply requires response from Tri-County, I will permit Tri-County a final opportunity to make a submission responding to the new material only within two weeks from its receipt of CMS's surreply brief. No further submissions by either party will be permitted thereafter.

The third issue relates to Tri-County's assertion that the Administrative Law Judge (ALJ) made an "off-record" comment that there was not consistency in the conduct of hearings. Tri-County Reply Br. at 12. CMS argued that no evidence existed of such an ex parte comment, that it was irrelevant in any case, and that it was not raised in the request for review. CMS Brief in Support of Motion at 2. Tri-County denied that it was referring to any ex parte communication and asserted, rather, that the comment occurred during the hearing but that it was not reflected in the transcript. Tri-County Opposition to the Motion at 2. The context to which Tri-County pointed was a discussion of whether the ALJ should have permitted CMS to conduct re-direct examination under circumstances in which Tri-County's counsel asserted that another ALJ had denied that opportunity to CMS. Id.; Transcript of May 28, 2003 Hearing at 178-181. Tri-County counsel asserted that he heard this statement and that his client's representative did as well, even if CMS counsel did not. Id.

Tri-County was provided an opportunity before the ALJ to note any prejudicial errors in the transcript of the hearing. Transmittal of Transcript, dated June 12, 2003. Tri-County did not assert at that time that any such omission from the official record existed. While Tri-County's post-hearing brief alludes to this alleged off-record comment, it does not include any claim that this comment was made at the hearing on the record but not reflected in the transcript. It would be inappropriate to take evidence at this stage of the proceedings in an effort to prove or disprove whether such a comment was ever made. Tri-County argued before us that the transcript demonstrated that the ALJ showed bias or hostility at the hearing. That issue must be resolved on the record of the hearing as Tri-County accepted it below and cannot now be supplemented with belated claims that the record is inaccurate. Therefore, I will not permit further evidence or argument by either party relating to this third issue.

Judith A. Ballard
Presiding Board Member

Cecilia Sparks Ford

Donald F. Garrett

Judith A. Ballard
Presiding Board Member

1. The full statutory language of the provision quoted by Tri-County provides that the Secretary shall have both "full power and authority to make rules and regulations and to establish procedures, not inconsistent with the provisions of this subchapter, which are necessary or appropriate to carry out such provisions, and shall adopt reasonable and proper rules and regulations to regulate and provide for the nature and extent of the proofs and evidence and the method of taking and furnishing the same in order to establish the rights to benefits hereunder." 42 U.S.C. � 405(a) (emphasis added). This language, and the cases cited by Tri-County interpreting it, related to disability hearings for beneficiaries, and its applicability to providers seeking to participate in the Medicare program is not entirely clear. Further, the conjunctive phrasing suggests that the Secretary may establish at least some necessary and appropriate procedures without formally adopting regulations.

2. The court ultimately found that the particular Ohio traffic statute in question did not set up a specific duty but merely codified the general duty of due care. Id. at 374.

3. This measure of severity based on "risk" of harm in assessing regulatory compliance contrasts with the usual requirement of proximate causation of harm for private recovery of damages in tort cases, highlighting the very different purposes of the two strains of law beyond the federal/state sources.

4. Tri-County is incorrect in asserting that, because the ALJ found it unnecessary to reach the other two residents cited in the SOD under Tag F324, therefore Tri-County has prevailed as to those findings. Tri-County Br. at 16. The ALJ concluded that the findings related to Resident 116 were sufficiently egregious to support the immediate jeopardy citation. Since the CMP imposed for the immediate jeopardy finding was the minimum amount permitted by regulation (as Tri-County acknowledged), the ALJ would have been unable to lower the penalty amount or otherwise alter the remedy even had he found the other two instances unsupported, and hence he elected not to evaluate them in detail. He noted, however, that even though he did not fully address the allegations as to Residents 105 and 108 under this tag, he made factual findings about them under Tag F272 which also support the conclusion of a deficiency under Tag F324. ALJ Decision at 11, n.6. Furthermore, he expressly concluded that "both these residents were also at risk for side rail entrapment, yet Petitioner did not implement measures to protect them from that type of accident." Id. at 24.

5. Questions were also raised at the hearing about whether the facility failed to notify the coroner of the resident's death until the resident's son insisted that it be done. Tr. at 36. The ALJ described the facility's failure as "interesting," but noted correctly that it was not "essential for CMS to establish a causal relationship between the resident's death and the entrapment." ALJ Decision at 24.

6. Tri-County also asserted that the surveyor reported hospital notes showing that the resident told the hospital physicians that she had had a fall but that CMS failed to produce these notes and that Tri-County was never able to review them. Tri-County Br. at 17. This assertion is odd, because the hospital notes appear in the record, were produced originally by Tri-County to the surveyor, and do contain the note that the patient "states that at the nursing home, she fell out of bed yesterday." CMS Ex. 27, at 30.

7. Interestingly, Tri-County cited its source for the osteoporosis diagnosis and the pre-existing spinal fractures as 1998 x-ray reports, but the facility's own comprehensive assessment of the resident, dated March 9, 2000, did not check the boxes for either osteoporosis or pathological bone fracture among the resident's diagnoses, while reporting the prior hip fracture and a history of falls. P. Ex. 2, at 10-11. The assessments require reporting only of those diagnoses which affect current status and risks, include "medical treatments, nursing monitoring, or risk of death." Id. The point is not that omitting these diagnoses was necessarily an error, but that the facility's contemporaneous assessment casts further doubt on the claim that the staff consciously concluded that the investigation of the cause of the new fracture was unnecessary because it was known to be a spontaneous result of an ongoing underlying disease process.

8. CMS erroneously asserted that no risks were identified on this form as associated with the resident's use of side rails. CMS Br. at 38-39.

9. The surveyor was asked what she meant by saying that Tri-County did not "adequately" assess the safety risk "with the use of the side-rails with the gaps," but testified that "adequate" to her as a surveyor meant the same thing as "comprehensive" and was judged simply by "looking at the assessment to see if it is comprehensive." Tr. at 160. It thus does not appear that the surveyor was raising a separate issue as to the quality of the safety risks assessments which were done and did include entrapment as a factor to consider.

10. Our conclusion that no deficiency was made out under 42 C.F.R. � 483.20(b) does not have any impact on the our use of the factual findings in relation to Tag F324. Tri-County made no challenge before us to the facts found by the ALJ under this tag which are relevant to Tag F324. We do not conclude that any of those findings were erroneous. We conclude only that the facts as found in the context of the record as a whole do not show a failure to perform an assessment of entrapment risk.