SUBJECT:

Koester Pavilion,

Petitioner,

Health Care Financing Administration.

Civil Remedies CR650
App. Div. Docket No. A-2000-69
Decision No. 1750

FINAL DECISION ON REVIEW OF

ADMINISTRATIVE LAW JUDGE DECISION

The Health Care Financing Administration (HCFA) appealed the February 29, 2000 decision of Administrative Law Judge (ALJ) Jill S. Clifton concluding that Petitioner, Koester Pavilion (Koester), was in substantial compliance with Medicare participation requirements. Koester Pavilion, DAB CR650 (2000) (ALJ Decision). HCFA had determined that Koester was not in substantial compliance during 50 days from July 9, 1997 through August 28, 1997, and that during the first day of the period the cited conditions posed an immediate jeopardy. Based on these findings, HCFA imposed a civil money penalty (CMP) of $3,050 for the first day and $50 per day thereafter, for a total CMP of $5,550. The ALJ found that Koester was in substantial compliance with each of the regulations for which HCFA cited it during the period at issue, and therefore concluded that HCFA was not authorized to impose any CMP on Koester. For the reasons explained below, we affirm the ALJ Decision in part and reverse it in part. We conclude that HCFA is not authorized to impose the CMP of $3,050 because Koester was in substantial compliance with the participation requirement on which the immediate jeopardy determination was based. We also conclude, however, that HCFA is authorized to impose the $50-per-day CMP for the fifty-day period cited by HCFA because Koester was not in substantial compliance with two remaining participation requirements.

Background

Koester is a 150-bed skilled nursing facility (SNF) located in Troy, Ohio, and participates in the Medicare program under a provider agreement with the United States Department of Health and Human Services (HHS). Koester is subject to periodic surveys to determine its compliance with the statutory and regulatory requirements of participation imposed on all SNFs. See generally Section 1819 of the Social Security Act; 42 C.F.R. Parts 483, 488, and 489. A survey of Koester was conducted by the Ohio Department of Health (a State survey agency with which HCFA contracted for this purpose) from July 7 - 10, 1997.

The surveyors cited three participation requirements with which Koester was not in substantial compliance. P. Ex. 30.⁽¹⁾ The most serious finding was under F Tag 323, alleging that Koester violated a quality of care requirement to provide a "resident environment . . . as free of accident hazards as possible" and that the violation presented an immediate jeopardy to resident health and safety. 42 C.F.R. § 483.25(h)(1); P. Ex. 30, at 31-39. The F Tag 323 citation was based on the surveyors' observation on July 9^th of one male resident we refer to as Resident (R.) 113. The surveyors questioned whether bed rails were used properly in conjunction with R. 113's Posey waist restraint.

The surveyors also cited Koester under F Tag 324 for failing to provide adequate supervision or assistive devices to prevent accidents to which they assigned a level of G (isolated actual harm that is not immediate jeopardy). 42 C.F.R. § 483.25(h)(2); P. Ex. 30, at 40-41. The surveyor findings in relation to this tag related to two residents (R. 24 and R. 134) who sustained falls.

Finally, Koester was cited under F Tag 314 for failing to prevent new pressure sores unless clinically unavoidable or to provide necessary treatment to those who arrived with pressure sores. 42 C.F.R. § 483.25(c); P. Ex. 30, at 28-31. The surveyors also assigned a level of G to this tag in relation to their findings about four residents who suffered from pressure sores (R. 24, R. 44, R. 30, and R. 8).

Applicable Legal Provisions

For purposes of surveys of facilities like Koester, the regulations define "substantial compliance" as "a level of compliance with the requirements of participation such that any identified deficiencies pose no greater risk to resident health or safety than the potential for causing minimal harm." 42 C.F.R. § 488.301. "Immediate jeopardy" 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." Id.

The three participation requirements (two relating to accidents and one to pressure sores) under which Koester was cited all fall under the rubric of "quality of care" requirements and share the same regulatory objective that "[e]ach 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." 42 C.F.R. § 483.25. The specific provisions at issue were the following:

Accidents. The facility must ensure that -

(1) The resident environment remains as free of accident hazards as is possible; and

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

42 C.F.R. §§ 483.25(h).

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

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

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

42 C.F.R. § 483.25(c).

Before the ALJ, a facility must prove substantial compliance by the preponderance of the evidence, once HCFA has established a prima facie case that the facility was not in substantial compliance with one or more participation requirements. Hillman Rehabilitation Center, DAB No. 1611 (1997), aff'd sub nom Hillman Rehabilitation Center v. U.S. Dept. of Health and Human Services, No. 98-3789(GEV), slip. op. at 25 (D.N.J., May 13, 1999). However, HCFA's determination that a deficiency constituted immediate jeopardy must be upheld unless the facility proves that the determination was clearly erroneous. 42 C.F.R. § 498.60(c)(2); see also Woodstock Care Center, DAB No. 1726, at 9 (2000).

Issues

HCFA excepted to the following Findings of Fact and Conclusions of Law (FFCLs):

FFCL No. 5. The provider did abide by the Posey in-bed waist restraint cautionary instructions in the manner in which the provider used the restraint for Resident 113.

FFCL No. 6. Considering the totality of the circumstances, including for example the properly applied waist restraint which among other things kept Resident 113 in the middle of the bed, Resident 113's slight stature which kept his legs from going off the edge of his bed, and the many means used by the provider to monitor Resident 113 while he was in bed, I find that the manner in which Resident 113's in-bed waist restraint was used was not an accident hazard.

FFCL No. 7. The provider was in substantial compliance with the quality of care requirement concerning accidents that is found at 42 C.F.R. § 483.25(h)(1).

FFCL No. 8. There was no immediate jeopardy and HCFA's determination that there was immediate jeopardy was clearly erroneous.

FFCL No. 9. The provider was in substantial compliance with 42 C.F.R. § 483.25(h)(2), a quality of care requirement to ensure that each resident receives adequate supervision and assistance devices.

FFCL No. 10. The provider was in substantial compliance with 42 C.F.R. § 483.25(c) for prevention and treatment of pressure sores.

FFCL No. 11. The provider was in substantial compliance with Medicare participation requirements, and HCFA was not authorized to impose a CMP.

ALJ Decision at 4 (citations omitted).⁽²⁾ HCFA raised no exception to the first four FFCLs in the ALJ Decision, and we affirm them without further discussion. ALJ Decision at 3-4.

HCFA argued that the ALJ applied the wrong standard in evaluating the immediate jeopardy deficiency finding. HCFA argued that the ALJ should have applied the clearly erroneous standard, for the meaning of which it cited two Supreme Court cases, in evaluating this finding. HCFA Br. at 3-4. Under that standard properly applied, HCFA argued its finding of noncompliance at the immediate jeopardy level must be upheld. Id. at 3-16. HCFA also argued that the ALJ erred as a matter of law in not giving weight to the expert testimony of the surveyors and in holding immediate jeopardy exists only where actual harm occurs. Id. at 11, 13-16. Further, HCFA argued that immediate jeopardy exists when "a situation is life-threatening . . . a situation that is 'likely' to cause harm." HCFA Br. at 15. HCFA contended that the facts in this case met that standard in light of guidance in the manufacturer's instructions and in FDA alerts about the seriousness of the threat where restraints are used with side rails. See, e.g., P. Ex. 30, at 80-82.

As to the alleged failure to provide adequate supervision or devices to prevent accidents, HCFA argued that the ALJ erred in finding that Koester took all reasonable measures to prevent falls. HCFA Br. at 20. As to the pressure sore deficiency, HCFA argued that the ALJ erred in concluding that the regulation was not violated where the facility promptly treated a newly-developed pressure sore and where the identified problems were isolated rather than constituting a pattern. HCFA Br. at 16.

Below, we first discuss the contentions about the immediate jeopardy deficiency. We then address the parties' arguments concerning whether Koester failed to take requisite measures to prevent falls by two residents. Finally, we discuss the deficiency findings regarding pressure sores.

Standard of Review

Our standard of review on disputed issues of fact is whether the ALJ Decision is supported by substantial evidence on the record as a whole. See, e.g., Lake Cook Terrace Nursing Center, DAB No. 1745 (2000). Our standard of review as to disputed issues of law is whether the ALJ Decision is erroneous. Id.

Analysis

1. The ALJ did not err in finding that Koester was in substantial compliance with 42 C.F.R. § 483.25(h)(1).

In considering the findings relating to this deficiency, we first address whether the ALJ employed the correct burden of proof to reach her determination that Koester was in substantial compliance with the applicable participation requirement. We then consider whether the ALJ erred by requiring HCFA to prove that actual harm occurred in order to substantiate immediate jeopardy. Next, we consider HCFA's challenges to the ALJ's factual findings on this issue. Finally, we turn to HCFA's argument that the ALJ erred in failing to credit and give appropriate weight to the testimony of its expert witnesses.

A. The clearly erroneous standard applies only to HCFA's determination of the scope and severity of the deficiency, not the existence of the deficiency.

HCFA treated the regulatory requirement that HCFA's determination that the level of noncompliance constituted immediate jeopardy must be upheld unless clearly erroneous, as requiring the ALJ to evaluate all of HCFA's evidence on this deficiency by that standard. For the reasons given below, we conclude that the higher "clearly erroneous" standard must be met to overturn HCFA's evaluation of the scope and severity of a deficiency as presenting immediate jeopardy, but that a provider may prevail on a claim that there was no such deficiency present by showing substantial compliance by the preponderance of the evidence.

In reviewing the F Tag 323 deficiency, the ALJ had to answer two questions. See ALJ Decision at 4. The first question was whether Koester was in substantial compliance with the provision. To answer that question, the ALJ stated, and prior cases establish, that HCFA must present a prima facie case with evidence that, if credible and unrebutted, would constitute proof that Koester was not in substantial compliance with the cited regulatory provisions. See ALJ Decision at 2. Koester then had the ultimate burden of showing by the preponderance of the evidence that it was in substantial compliance with each provision. ALJ Decision at 2.

Had Koester been found to be out of substantial compliance with 42 C.F.R. § 483.25(h)(1), which was cited at the immediate jeopardy level, then the second question presented would have been whether the level of non-compliance found presented an immediate jeopardy to resident health and safety. To answer that question, the regulations provide, and the ALJ correctly observed, that HCFA's determination as to the level of non-compliance must be upheld unless it is clearly erroneous. 42 C.F.R. § 498.60(c)(2); ALJ Decision at 2. Further, the level of noncompliance is subject to review only if a "successful challenge . . . would affect the range of [CMP] amounts that HCFA could impose." 42 C.F.R. § 498.3(b)(13).

This second question therefore arises only where the noncompliance was cited at a level of immediate jeopardy. As the Board has previously explained, no appeal may be had of HCFA's determination of the level of noncompliance, unless a change in that level would affect the available range of CMP, which would occur only when a facility challenges a finding by HCFA that the level of noncompliance was above the immediate jeopardy threshold so as to trigger a CMP range of $3050 or greater. 42 C.F.R. § 498.3(b)(13); Careplex of Silver Spring, DAB No. 1683, at 15 (1999).

HCFA's regulations thus clearly provide for review of the factual basis for a deficiency finding on which a proposed sanction is based, but preclude review of the determination of the level of noncompliance in a non-immediate jeopardy case. The preclusion of review of the second question does not imply preclusion of the first, since the factual basis of a noncompliance finding is expressly made appealable, so long as it results in proposed imposition of one of the specified remedies. 42 C.F.R. § 498.3(b)(12). Accordingly, it follows that the imposition of a higher standard of review of determinations that a deficiency posed an immediate jeopardy does not imply application of that higher standard to the review of the factual basis of the underlying deficiency finding. See generally Cross Creek Health Care Center, DAB No. 1665, at 18-20 (1998).

On appeal, HCFA quoted the preamble to the regulations, and cited several court cases, for the proposition that "the clearly erroneous standard is a high burden for a facility to meet." HCFA Br. at 3-4. The statement is correct but inapposite. Contrary to HCFA's argument, the ALJ did not incorrectly apply the clearly erroneous standard in deciding whether a deficiency existed as a matter of fact; rather, the ALJ correctly applied the preponderance of the evidence standard to that question.

The preamble language relied on by HCFA makes clear that the reasoning behind raising the facility's burden of proof applies only to the classification of the level of noncompliance represented by the particular circumstances surrounding a deficiency finding. Thus, the high burden is said to be appropriate in the case of "upsetting survey findings relating to the level of noncompliance," because the factors of "frequency and seriousness" by which the level is measured are not "mathematical judgments for which there are clear or objectively measured boundaries." 59 Fed. Reg. 56,179 (emphasis added). The preamble goes on to state that "[t]hus, in [CMP] cases, whether deficiencies pose immediate jeopardy, or are widespread and cause actual harm that is not immediate jeopardy, or are widespread and have a potential for more than minimal harm that is not immediate jeopardy does not reflect that a precise point of noncompliance has occurred but rather that a range of noncompliance has occurred which may vary from facility to facility." Id. This discussion of the difficulty and subjectivity of measuring a particular level of noncompliance presupposes the existence of one or more deficiencies and assumes that the question remaining is how frequent and serious the resulting noncompliance is in its impact on residents. Because these "less than perfectly precise concepts" are very difficult to quantify or second-guess, the preamble makes clear that an ALJ is required to "uphold State or HCFA findings on the seriousness of facility deficiencies in [CMP] cases unless clearly erroneous." Id. (emphasis added).

In the present case, the ALJ concluded that no deficiency under 42 C.F.R. § 483.25(h)(1) existed. This conclusion was based on her findings that Koester had proven that it was in substantial compliance with those requirements. ALJ Decision at 12. As a result of that conclusion, the ALJ found that no immediate jeopardy existed. Id. The ALJ went on to also find that the immediate jeopardy determination was clearly erroneous. Id.

Where no deficiency exists, it necessarily follows that no issue arises about the correct level of the deficiency. The Board previously articulated this rule in Lake Cook Terrace Nursing Center, DAB No. 1745, at 6 (2000), as follows -

The purpose of the clearly erroneous standard at 42 C.F.R. § 498.60(c)(2) is to accord deference to HCFA's evaluation of the seriousness and effect of any deficiency. It presupposes a finding that the deficiency exists and therefore is inapplicable once an ALJ reverses the deficiency finding.

While the further finding that the level was clearly erroneous may hence not have been strictly necessary, we find no error in the ALJ's conclusion. We therefore turn next to HCFA's challenges to the ALJ's conclusion that Koester had proven that it was in substantial compliance with the cited provision. For that purpose, the applicable standard is whether there is substantial evidence in the record as a whole that supports the ALJ's determination that Koester proved substantial compliance by the preponderance of the evidence.

B. The ALJ did not require a showing of actual harm to meet the definition of immediate jeopardy.

We find that HCFA misread the ALJ Decision as holding that a resident must actually slip off the bed before a likelihood of harm from improper use of side rails could be found. HCFA Br. at 5. HCFA quoted an excerpt from the ALJ Decision which read:

Was it possible for Resident 113 to have been injured by the in-bed waist restraint in the absence of full side rails? No actual injury or harm to Resident 113 occurred. No alarming event occurred. If Resident 113 were to have slid off the edge of his bed and to have become entrapped in his waist restraint, the harm would have been more than minimal; it would have been life threatening.

ALJ Decision at 11, quoted in HCFA Br. at 14. From this language, HCFA concluded that the ALJ interpreted the regulation to require the resident to actually become "caught in the side rails, or suspended from the restraint belt . . . before harm is likely." HCFA Br. at 14. We disagree with HCFA's reading of the ALJ's language.

The Board has previously held that no showing of actual harm is required to support a finding of immediate jeopardy if the risk of harm is imminent and serious enough.

Indisputably, the regulation does not require any finding of actual harm to justify a determination that immediate jeopardy to residents exists. "Immediate jeopardy" is defined in 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). "Jeopardy" generally means danger, hazard, or peril. . . . The focus of the determination of immediate jeopardy is on how imminent the danger appears and how serious the potential consequences would be. . . . The language of potential and risk is hence entirely appropriate in considering these questions.

DAB No. 1726, at 38. While the phrasing may have been less than completely clear, a close reading of the ALJ Decision as a whole shows no inconsistency with our prior holdings. HCFA omitted the language from the ALJ Decision which immediately follows its quotation, in which the ALJ goes on to state -

Was there a risk to resident health and safety greater than potential for causing minimal risk? . . .  The preponderance of the evidence proves no such risk.

ALJ Decision at 11.

The ALJ then listed the specific facts and circumstances that convinced her that, while a misuse of restraints and rails could be indeed very dangerous, the manner in which they were used here did not present an accident hazard. Id. The ALJ's observation that, in the present case, no actual harm to the resident occurred does not imply that immediate jeopardy could not result from noncompliance absent actual harm in an appropriate case. The ALJ specifically stated that, "[i]n another case," she might well find that a failure to use full-length rails did present an accident hazard, "but not here." ALJ Decision at 11. The ALJ thus correctly considered both actual harm and the degree of potential harm.

After thus concluding that Koester was in substantial compliance with this participation requirement, given the totality of the surrounding facts, the ALJ then considered whether the immediate jeopardy determination had been clearly erroneous. The ALJ noted that no actual harm took place, but that, had there been noncompliance, the potential for harm could have been very serious, even life-threatening. However, that serious potential for harm was not presented here at all, given all the facts credited by the ALJ in relation to the use of the restraint, because proper procedures were followed in applying the restraint and rails, and additional care was taken to minimize any residual risk. Therefore, the ALJ concluded that the immediate jeopardy determination was also clearly erroneous. We find no legal error in this conclusion. We therefore turn to the specific circumstances which convinced the ALJ that the use of the waist restraint and side rails here was not a hazard to determine if the ALJ's findings were supported by the record.

C. Substantial evidence in the record as a whole supported the ALJ's finding that, under all the circumstances, the manner in which Resident 113's in-bed waist restraint was used was not an accident hazard.

The single episode which led to the deficiency finding was the result of two surveyors' observations of R. 113 in bed one morning with a waist restraint on and side rails raised on the upper part of the bed but no side rails covering the lower part of the bed. The physician and facility had concluded that R. 113 required a waist restraint in bed because of his medical condition and his history. P. Ex. 75, at 27, 50. The surveyors did not question the necessity for the waist restraint but concluded that the use of side rails that did not extend the full length of the bed violated guidance from both the FDA and the restraint manufacturer. P. Ex. 30, at 39. They feared that R. 113 could potentially move off the bed and become entangled or strangled by the restraint belt. Id. They cited this condition as violating the requirement that residents should be provided an environment as free from accident hazards as possible. 42 C.F.R. § 483.25(h)(2).

In concluding that no accident hazard was present, the ALJ stated that she considered the circumstances as a whole, and focused on the following six specific factors as most important:

(1) the correctly applied waist restraint;

(2) the resident's position in the middle of the bed;

(3) the resident's inability to shift his body laterally toward the edge of the bed [he could only rotate on his axis];

(4) the resident's slight stature and legs which were too short to reach over the side of the bed;

(5) the many ways the provider monitored the resident; and

(6) the provider's compliance with the manufacturer's instructions by having side rails up that would not allow Resident 113's body or limbs to fit over, under, around, through, or between side rails.

ALJ Decision at 11-12. We discuss HCFA's arguments as to each in turn and explain why the record evidence as a whole is sufficient to support the ALJ's findings.

HCFA acknowledged that factors one and two were not themselves in dispute, but argued that the ALJ erred by omitting from them the further information offered in the surveyors' testimony that their real concern was the "lack of continuous bed rails" and that "a properly applied waist restraint allows for side to side movement, thereby necessitating bed rails that do not have gaps." HCFA Br. at 11-12. The surveyors themselves, as well as Koester staff, testified to the accuracy of the facts underlying these two factors.⁽³⁾ Tr. at 32 (Davis), 37 (Davis), 113 (Cobb), 301 (Gray), 332 (Wiley). The surveyors did not have a concern about the selection of the particular restraint, the manner in which it was applied to the patient or affixed to the bed, the positioning of the patient in the bed, or the efficacy of using a waist restraint with the resident while in bed. Tr. at 32, 88, 126-27. Their concern rather was with the restraint system as a whole, i.e., the combination of the type of side rail used with the waist restraint. Tr. at 33. HCFA's argument about the potential for movement is more relevant to the third factor and its assertion of a requirement for "continuous bed rails" is more relevant to the sixth factor. We find no real dispute in the record concerning the accuracy of the first two factors, and we discuss HCFA's proposed additional information below in relation to the relevant factors.

Regarding the third factor, the record contains considerable discussion about the kind of movement permitted by a properly-applied waist restraint. Ms. Davis, a nurse who was one of the surveyors, stated that "waist restraints allow the resident to roll from side to side and the waist is the only area that is secure so the bottom half of the body can move from side to side as well as the top half of the body." Tr. at 37. However, Ms. Cobb, another surveyor, testified that in her training and experience, how much side-to-side movement would be possible "differs with individuals, depending on their size and the size of the restraint . . . ." Tr. at 134. Koester's charge nurses testified that R. 113, in this restraint, which was properly applied, could only turn from left to right on his axis but could not move laterally in either direction. Tr. at 277-78 (Stine), 294 (Gray). The ALJ credited the latter assessment.⁽⁴⁾ ALJ Decision at 11. The charge nurses testified as to the actual mobility of this patient in this restraint, and spoke from longer experience with his circumstances than the surveyors who testified that they observed him only briefly twice within fifteen minutes on one morning.

As far as the fourth factor, the surveyors agreed with Koester staff that R. 113 was small in stature, and uncontradicted testimony established that he was between four feet and ten or eleven inches and weighed about 130 pounds. Tr. at 127 (Cobb), 275 (Stine), 295 (Gray), 332 (Wiley); ALJ Decision at 7; see also P. Ex. 75, at 14. The parties did dispute, both before the ALJ and on appeal, whether R. 113's size made it impossible for him to slide off the sides of the bed or slip "over, under, around, through, or between side rails." See ALJ Decision at 11. The bed rails used were 37 inches long; the hospital bed was stipulated to be 84 inches long; full length side rails are, according to provider testimony that was not contradicted, about 57 inches long.⁽⁵⁾

One surveyor, Ms. Cobb, testified at one point that the railing began about two inches from the top of the bed, making it unlikely that a resident could fit over the rails, and ended "not much past [R. 113's] midsection," while, at another point, she described the side rail as extending "from the midthigh up to the top of the bed" leaving R. 113's "knees . . . free to move about." Tr. at 113-114, 131-34. Koester's witnesses agreed that it was possible to swing one's legs to the side while in a waist restraint, but testified that, in the case of this individual, his legs could not "hang over the side of the bed" because his feet barely reached the edge. Tr. at 291 (Gray), Tr. at 282 (Stine). Thus, asked how R. 113's small stature related to his safety in this bed system, she explained: "[H]is legs aren't long enough to go over the rail. . . . He is just not able to do that. . . . Because of his size." Id. at 295-96; see also Tr. at 299-02.

HCFA's witnesses appeared to treat any possibility of an extension of any portion of R. 113's body beyond the edge of the mattress as presenting the danger of suffocation or chest compression. See, e.g., Tr. at 134-36 (Cobb).⁽⁶⁾ However, none of HCFA's witnesses described any specific scenario whereby such entrapment could occur without any portion of the body extending past the edge and around or through the rails enough to dangle. See P. Br. at 7-8 (and record cites therein). HCFA's argument on this point seemed rather to be derivative from the FDA Alert and manufacturer's instructions, which, as discussed in relation to the sixth factor, HCFA read as warning of a danger of entrapment in any case where a waist restraint is used in bed without full, continuous, covered side rails. See generally HCFA Br. at 12; Tr. at 36-37 (Davis), 134-136 (Cobb).

The ALJ, on the other hand, focused on whether, as a question of fact, R. 113's legs could actually "reach over" the edge of the bed, so that he could potentially move around or through the railings, rather than, for example, simply touch the edge with his feet. See ALJ Decision at 11. In this regard, she credited testimony that R. 113's small stature and the constraints on his movement were such as to preclude him from sliding past the edge of the bed so as to become entrapped and incur the risk of suffocation or chest compression. To the extent that HCFA's witnesses actually disagreed with Koester's staff about how far R. 113's legs could reach around the end of the side rail and extend beyond the edge of the bed, we defer to the ALJ's evaluation of the credibility of the witnesses on this question of fact. We address in regard to the sixth factor HCFA's position that entrapment is per se a risk because the restraint system did not comply with manufacturer's instructions.

The fifth factor involved the close monitoring provided to R. 113. As the ALJ noted, the doctor ordered that the patient be monitored every 30 minutes and released and repositioned for ten minutes every two hours around the clock. ALJ Decision at 6; P. Ex. 75, at 24; Tr. at 296. In addition to finding that the staff complied with that order, the ALJ credited testimony of Koester staff that R. 113's room was located near the nurses' station to allow monitoring and had video and audio equipment which could be viewed at the nurses' station (in the nature of a baby monitor set-up). ALJ Decision at 6; Tr. at 290-91 (Gray), 332-33 (Wiley). Furthermore, the ALJ credited testimony that these measures were supplemented at times by stationing a staff person to sit at the door and at times by continuous one-on-one monitoring. ALJ Decision at 7; Tr. at 290 (Gray). Ms. Davis testified, in response to Ms. Gray's assertion on the last point, that she never saw anyone outside R. 113's door or in his room when she made her observation of him during the survey. Tr. at 347. However, this rebuttal does not prove that Ms. Gray was incorrect in her statements. Ms. Gray's description was that, among the measures adopted to deal with R. 113's propensity to fall (including use of a Posey alarm and a wheelchair "lap buddy," as well as monitoring measures, and ultimately the waist restraint), the provider "did one-on-one with him" in which a staff assistant "stayed with the resident at all times." Tr. at 201. This assertion does not imply that one-on-one was in place continuously 24 hours every day, as HCFA inferred. Further, Ms. Gray was asked if Koester would ever "station staff in or near his room," and responded that: "Resident 113 was right at the nurses' station, his room was at the nurses' station. And, we would have staff to sit outside the door so that they could - you know, if he was to rustle around or move, they could be there to check." Tr. at 291. Again, this testimony does not assert that someone was stationed by the door at every minute. According to Ms. Cobb, Ms. Davis observed R. 113 for less than ten minutes on the morning of July 9, 1997 between 7:45 and 8 A.M. at which point the surveyors had completed their observations and turned to writing their findings. Tr. at 163-65. Therefore, the ALJ's finding that such monitoring was provided at times, supplementing the round-the-clock monitoring at 30 minute intervals, is not undermined by testimony that it was not observed during one period within a 15-minute interval.

The sixth factor is the most contentious. Neither side contested the ALJ's conclusion that a failure to abide by manufacturer's instructions is important but does not per se demonstrate an accident hazard; rather, "all the specific circumstances must be evaluated." ALJ Decision at 4, FFCL No. 2. HCFA strongly disputed, however, the ALJ's conclusion that Koester did abide by the manufacturer's instructions in the way it used the restraint here. HCFA argued that Koester's use of partial rather than full side rails violated the manufacturer's instructions. Further, HCFA argued that this misuse presented precisely the dangers reflected in an FDA Alert relied on by the surveyors in assessing immediate jeopardy. HCFA Br. at 8-9.

Koester responded in its Plan of Correction that it was complying with the manufacturer's instructions applicable at the time by meeting the following requirements:

(1) a physician's order;
(2) an assessment by the interdisciplinary team;
(3) continuous monitoring of placement of the restraint and of the resident;
(4) siderails must be in the "up" position when using restraints; and
(5) if necessary, use a siderail cover, especially with split siderails, to prevent the patient's body from going under, around, through or between the siderails.

* * *

These instructions [referencing an attached version] . . . do not mandate the use of full siderails with a cover, but provide an allowance for the facility to make a determination in their professional and medical judgment, the type of siderail to be used with or without a siderail cover. This determination is to be made through frequent monitoring and review/evaluation of the resident's status by the facility and the attending physician, which has been done.

P. Ex. 30, at 32-33, 77; P. Br. at 5-6.

The ALJ considered both the question of which instructions were applicable and the question of how the applicable instructions should be interpreted. She concluded that Koester's use of these side rails in the up position, even without padding or full-length railing, was within the ambit of the applicable manufacturer's instructions. ALJ Decision at 8-11.

It is uncontested that the side rails on R. 113 were in the up position and were, as noted, ½ to 3/4 length. ALJ Decision at 4, unchallenged FFCL No. 4. The surveyors agreed at the hearing, despite some confusion, that the side rails used with R. 113 were not of the kind generally known as a split rail system, which involves four smaller rails, two on each side along the head and foot of the bed and a large gap between them. Tr. at 87, 90; but see Tr. at 99-100; see also HCFA Ex. 10, at 2 (photo of split rail).⁽⁷⁾ HCFA argued before us, however, that the ALJ was mistaken that it mattered whether the rails were split rails or partial length side rails, because that was "not the focus of the surveyors' concern," but rather they were worried about Koester's failure to use rails that extended the full length of the bed. HCFA Br. at 6-7. We disagree. The core of the dispute here was over whether these side rails (not split rails) were adequate to comply with the requirement for continuous rails in the up position.

Although HCFA saw no relevant difference among them, it is clear that several versions of the manufacturer's printed instructions for proper use of restraints were in the record.⁽⁸⁾ Compare HCFA Ex. 10, at 1; with P. Exs. 6, at 1; 7, at 3; 30, at 77; and 76, at 1; see also ALJ Decision at 8. The ALJ determined that the applicable version was that issued closest to the time of the survey, i.e., in 1993 rather than 1992, while the surveyors apparently had relied on the older version judging by the language used in the original 2567 form. ALJ Decision at 9-10; HCFA Ex. 3, at 5; P. Ex. 30, at 32. HCFA offered no persuasive reason why an older version of these safety instructions should be relied on rather than the most current version, and we therefore accept the ALJ's conclusion as to the applicable version.

The later version, entitled "Safety Instructions for the Use of Posey Restrictive Products," provided the following guidance:

Siderails must be in the UP position when using restraints in bed. Do not use any siderail that will allow the patient's body or limbs to fit over, under, around, through, or between siderails and become suspended in the restraint, resulting in chest compression and suffocation. Use siderail covers (seizure pads) if necessary.

P. Ex. 7, at 1. The ALJ noted that the language above did not contain any caution to use only full length side rails as opposed to the partial length side rails used with R. 113. ALJ Decision at 11.⁽⁹⁾ The injunction not to use side rails of a kind that allow entrapment does not necessarily imply that all side rails except full and continuous ones always present entrapment risks regardless of the particular patient. It can be read, as Koester suggests, to require an exercise of professional judgment to assess what side rail system might allow such events in particular circumstances.

In considering whether this reading is reasonable, it is helpful to consider what changes were made from the older instructions on which the surveyors relied. The corresponding section previously read as follows:

Full and continuous covered bed side rails should be in the UP position when any restrictive product is used in bed. The patient's buttocks should be positioned in the middle of the bed, and side rail covers should be used if openings in the side rails would allow the patient to become entangled. Do not use ½ or 3/4 side rails - they could allow the patient to fall off the mattress and become entangled in the restrictive product.

HCFA Ex. 10, at 1. Given that the revision removed express language about avoiding partial length side rails and replaced it with language calling for an exercise of judgment about what side rail system fits the patient, the reasonable inference is that the manufacturer consciously concluded that partial length side rails were not a per se danger.

We conclude that the ALJ's findings about the circumstances surrounding the choice and use of this restraint system for R. 113 are supported by substantial evidence. We further conclude that the ALJ reasonably interpreted the applicable instructions as permitting the exercise of professional judgment in light of the particular circumstances. We discuss in the next section why we do not accept HCFA's arguments that the ALJ improperly ignored the testimony of its expert witnesses across the board regarding the risks and proper use of the R. 113's waist restraint and side rails.

D. We defer to the ALJ's assessment of the credibility of the witnesses, including HCFA's expert witnesses.

HCFA argued that the ALJ accepted two surveyors (Ms. Davis and Ms. Cobb) as expert witnesses and made no express findings that "their statements or opinions were not credible or merited little weight," and yet did not refer to or consider their testimony at all. HCFA Br. at 4. HCFA's argument both misstates the ALJ's Decision and misunderstands the role of expert witnesses.

In general, as an appellate body, we do not disturb an ALJ's assessment about the relative credibility of testimony by witnesses who appear in person at the hearing absent a compelling reason to do so. Thus, the Board has held that --

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

South Valley Health Care Center, DAB No. 1691, at 22 (1999).

Here, the ALJ did, in fact, reference the surveyors' testimony repeatedly; however, she determined that some of their statements or factual descriptions were simply "incorrect," misjudgments, or "mistaken." ALJ Decision at 6, 7, 11. While she did not make a general finding that they were not believable witnesses, or provide as explicit an explanation as might have been desirable of her evaluation of each witness, she addressed conflicts in the testimony and indicated which account she accepted and what facts Koester had proven. See ALJ Decision at 6-11 passim.

Accepting these witnesses as experts did not guarantee that the ALJ would then accord greater weight to their testimony. The ALJ expressly noted at the hearing that she would not necessarily do so. Tr. at 35 (Davis), 119 (Cobb). The testimony reflected that each witness had some relevant training and background (to differing degrees) that the ALJ, as finder of fact, did not personally possess. Tr. at 35-37, 108-19. On that basis, the ALJ permitted them to offer opinion testimony on narrow questions where that might assist her in understanding particular issues, and thus to go beyond the opinions or inferences generally permitted to lay witnesses. See generally Fed. Rules of Evid., Rules 701, 702. Further, much of the testimony which HCFA argued should have been accorded more weight went not to expert opinions but to observations of facts. On such matters, the question of expertise is not necessarily relevant. In addition, much of the testimony involved was based on premises underlying HCFA positions (such as the assumption that anything less than full side rails were per se violations of the instructions and necessarily presented the entrapment risks set out in the FDA Alert), which the ALJ rejected as a result of her independent review of the applicable documents which she was able to read and interpret herself. An expert's opinion lacks relevance when based on factual foundations that are not proven.

Furthermore, the purposes for which these witnesses were accepted as experts were narrow and their qualifications were limited in scope as well. HCFA did not seek to qualify them as experts overall. Rather, the ALJ permitted them to answer specific questions when challenged on the basis that they did not have sufficient qualifications to express opinions on those matters. For example, the ALJ stated she would treat Ms. Cobb as an expert witness (over objection) because Ms. Cobb might assist the ALJ in evaluating the issue of what type of rail system the surveyors were looking for to prevent falls.⁽¹⁰⁾ Tr. at 118-19. Ms. Cobb had testified that her professional training was as a dietician, but also that she had had training and experience in how to evaluate the proper use of restraints as a surveyor. Tr. at 109-11. Ms. Cobb testified that she was not trained as a nurse and had never applied a restraint or participated in a restraint assessment, although she had previously observed residents in bed restraints as a surveyor. Tr. at 117, 138. The ALJ allowed her to testify as an expert witness, but noted that other witnesses might be given greater weight. Tr. at 119.

Ms. Davis, the other surveyor who observed R. 113, was a registered nurse in addition to her training as a surveyor. Tr. at 28-29. Again over objection, the ALJ agreed to hear her opinion to assist in understanding a hypothetical (concerning whether the surveyors would have reacted differently had a different waist restraint been used). Tr. at 34-39. Again, the ALJ noted that the witness's opinion would not necessarily "carry the most weight." Tr. at 35.

In addition, we note that the witnesses presented by Koester whose testimony the ALJ largely credited concerning this deficiency also had professional backgrounds and experience described in the record which were relevant to the weight properly given to their opinions, as well as greater opportunities to observe the facts and circumstances surrounding the resident and episode at issue. Ms. Stine was a licensed practical nurse for more than 14 years and was serving as charge nurse at Koester. Tr. at 248-49. Ms. Gray was also a charge nurse, had been at Koester for more than seven years, and was familiar with this resident. Tr. at 289-90. Ms. Wiley was a registered nurse, had worked at two other facilities, and had been at Koester for two years. Tr. at 323. Her work included observing and evaluating residents, developing care plans, and coordinating care with unit charge nurses. Tr. at 324. HCFA did not object to the presentation of their opinion testimony. See, e.g., Tr. at 332 (Wiley). In a case where an ALJ found the testimony of expert witnesses for one party "more convincing" than that of the other party, the Board held that it "is within the ALJ's authority to weigh the evidence and judge the credibility of each witness." Bernard J. Burke, M.D., DAB No. 1576, at 14 (1996). In considering the ALJ's assessment of witnesses' credibility, "we must abide by that determination absent a compelling reason not to." Id.; see also DAB No. 1726, at 8-9 (2000), Oak Lawn Pavilion, Inc., DAB No. 1638 (1997).

We find no compelling reason to reject the ALJ's determination about the relative credibility and persuasiveness of the testimony of these witnesses. We conclude that the record as a whole, in light of the testimony credited by the ALJ, contains substantial evidence in support of the ALJ's conclusion that no accident hazard was present under all the circumstances.

E. We sustain the ALJ's findings and conclusion that Koester was in substantial compliance with 42 C.F.R. § 483.25(h)(1).

For the reasons explained above, we find no error in the ALJ's legal analysis of this deficiency finding, and we conclude that her factual findings are supported by substantial evidence in the record as a whole. Therefore, we sustain the ALJ's FFCLs numbered 5 through 8.

2. The ALJ's conclusion that Koester was in substantial compliance with 42 C.F.R. § 483.25(h)(2) is not supported by substantial evidence in the record.

Falls by two different residents, R. 24 and R. 134,⁽¹¹⁾ under very different circumstances, are at issue here. R. 24 slipped to the bathroom floor while being assisted by a single aide. The aide was able to ease her to the floor without her fully falling but in the process R. 24 sustained a skin tear. R. 134 had a history of serious falls when he was found on the floor by his bed three times in just over 24 hours.

In both situations, the surveyors determined that the facility had failed to ensure that the resident received "adequate supervision and assistance devices to prevent accidents." 42 C.F.R. § 483.25(h)(2). The surveyors explained their assessment of the severity of this deficiency in the Form 2567 as follows:

Failure to provide two residents with adequate supervision resulted in injury from falls. Two residents suffered actual harm in the form of skin tears and a fractured hip. This is actual harm that was not immediate jeopardy.

P. Ex. 30, at 26. In each case, the ALJ found that the facility did "everything within reason" to provide adequate supervision and assistance devices for the two residents who had suffered falls. ALJ Decision at 13, 15. HCFA argued that, on the contrary, the staff failed to provide either resident with even what the facility's own assessment showed that they needed. HCFA Br. at 21.

We first discuss the applicable standard imposed by the regulations. Next, after careful examination of the record and for the reasons explained below, we hold that substantial evidence supports the ALJ's conclusion that Koester provided adequate supervision to R. 24 to prevent accidents. See ALJ Decision at 13-14. For the reasons we explain thereafter, however, we reverse the ALJ's finding concerning R. 134 because it is not supported by substantial evidence in the record, which instead establishes that Koester did not take appropriate measures to forestall his repeated falling.

A. The applicable regulatory standard requires the facility to "ensure" for every resident "adequate supervision . . . to prevent accidents."

The ALJ considered Koester's compliance with 42 C.F.R. § 483.25(h)(2) in terms of whether the facility did "everything within reason" in supervising these residents. ALJ Decision at 13-15. The ALJ did not elaborate on the meaning of this phrase, and it is not clear whether by it she meant to employ the standard required by the regulation. See HCFA Br. at 21. We therefore address first the correct standard.

In meeting this particular requirement, the facility must ensure that its supervision is adequate to prevent accidents, in order to meet the overall quality of care requirement to provide what is necessary for each resident to "attain or maintain the highest practicable . . . well-being." 42 C.F.R. § 483.25. The high obligation to ensure the adequacy of the measures which it takes to effectuate this requirement does place a high expectation on the facility to achieve results, but it does not "amount to strict liability or require absolute success in an obviously difficult task." DAB No. 1726, at 27 (2000). As the Board explained in Woodstock, 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. Id. at 28-29. Under this "outcome-oriented" approach, facilities have the flexibility to use a variety of methods and approaches but they are responsible for achieving the required results. Id. In ensuring adequate supervision, thus, a facility is not required to do the impossible or be a guarantor against unforeseeable occurrence, but is required to do everything in its power to prevent accidents.

B. The ALJ's findings regarding R. 24's fall are supported by substantial evidence.

With respect to R. 24, the surveyors noted that her medical records indicated she had slipped to the floor on the morning of July 9, 1997 while being assisted to the bathroom. P. Ex. 30, at 40. A minimum data set (M.D.S.) form for R. 24, completed on February 11, 1997, and a second M.D.S. form completed on April 12, 1997 both reported R. 24 needing the physical assistance of two or more persons to move between locations in her room and the adjacent corridor. P. Ex. 71, at 100, 113. However, at the time of the incident, the nurse's notes report that a single nurse aide was helping R. 24 ambulate the short distance from her bed to the bathroom. R. 24 was also using a walker, but she nevertheless lost her balance and "was assisted to sit down [on] the floor." P. Ex. 71, at 29-30. While R. 24 was helped to lower herself, rather than fully falling, she sustained skin tears to her arm and shin in the process. Id. at 30.

HCFA contended that Koester itself had determined that extensive assistance from two staff members was required for R. 24, and that the facility's argument that the resident in fact at that point required less assistance while ambulating in her room to the toilet is belied by the very fact that she fell under those circumstances. HCFA Br. at 20.

The ALJ, however, credited testimony of three Koester staff members, Ms. Wiley, Ms. O'Brien and Ms. Stine, who agreed that the assistance being provided was appropriate and adequate for R. 24 under all the circumstances of the incident. They stated that R. 24 could and did safely manage for short distances, e.g., to the bathroom or from chair to bed, with a walker and a single assist. ALJ Decision at 13; Tr. at 253-54 (Stine); 309-10 (O'Brien), 334 (Wiley). Two staff members were indeed needed to assist her with ambulating longer distances, e.g., to the lounge or for meals. ALJ Decision at 13; Tr. at 334. The staff testified that R. 24's mental condition varied significantly, so that she required more supervision at some times than at others. ALJ Decision at 13; Tr. at 309 (O'Brien); Tr. at 253 (Stine).

As for the two-person assist noted in the M.D.S., Koester's staff testified that that represented a report of the highest level of support provided during the preceding seven days, but not necessarily an assessment of the minimum level of support required from that point on. Tr. at 333-34 (Wiley). The instructions for coding on the forms themselves support that testimony. P. Ex. 71, at 100, 111. Neither party identified any care plan or resident assessment that concluded that the level of support needed perhaps only once during particular weeks in February and April represented the baseline support that R. 24 needed in all circumstances. The M.D.S. form does not disclose whether that assistance was needed only when she ambulated outside her room and for longer distances, which the facility clearly felt called for two-person assists. By contrast, after the July 9^th fall, R. 24 was reassessed and her care plan changed to require assistance by two persons whenever she was being ambulated, as reported in Koester's Plan of Correction. P. Ex. 71, at 11; P. Ex. 30, at 40.

We defer to the ALJ's assessment of the credibility of the witnesses' accounts of R. 24 varying care needs. Substantial evidence supports the ALJ's determination that the record does not establish that R. 24 had required and been documented as needing two persons to assist with ambulation in her own room. ALJ Decision at 13.

The nursing record for this resident did contain reports of two earlier falls in June 1997. P. Ex. 71, at 21. One of those incidents did resemble the circumstances that occurred on July 7, 1997. In the earlier episode, a nurse aide was ambulating her to the bathroom when she fell and the aide was not able to catch her, resulting in some injuries. Id. at 22. However, no use of the walker is recorded in the earlier episode. Nothing in the record establishes that Koester had assessed the resident as needing to move to a two-person assist in ambulating to the bathroom. The facility could reasonably have determined that the addition of a walker would provide sufficient additional stability and that they could thereby preserve as much independence and self-sufficiency as possible for the resident. HCFA did not point to anything in the record to establish that this would not be an appropriate measure to ensure the resident's safety. Rather, HCFA argued that anything but the use of two-person assists was inconsistent with Koester's own assessment of R. 24's needs. We do not find that argument supported by the factual findings or by the evidence in the record as a whole.

The ALJ's conclusion that Koester complied with 42 C.F.R. § 483.25(h)(2) in its treatment of R. 24 is affirmed.

C. The ALJ's findings regarding R. 134's falls are not supported by substantial evidence.

With regard to R. 134, the surveyors found that, according to his medical records, this resident had broken his hip as a result of a prior fall while at the facility. P. Ex. 30, at 40-41. On July 2, 1997, at 3:45 A.M., his records showed that he was found on the floor by his bed, which resulted in some pain and bruising on his hip and thigh. Id. at 41. The next morning at 4:15 A.M., he was again found on the floor beside his bed resulting in a fracture of his left femur. Id. There was no dispute that this resident needed extensive assistance for ambulation. ALJ Decision at 17; P. Ex. 73. The surveyors noted that a bed alarm had been discontinued in February and that ½ side rails were used, but found that "the record was silent to any preventive measures in place to address this resident's high risk for falls." P. Ex. 30, at 41.

The ALJ accepted the explanation of Koester staff that they had done all they could to avoid dangerous falls by R. 134, but were stymied in their efforts because R. 134 was resistant, uncooperative, and engaged in attention-getting, but self-destructive behaviors beyond their control. ALJ Decision at 14-15. This finding was based on testimony from a charge nurse that this resident was a noncompliant "attention seeker" who would deliberately sit down on the floor, threaten to fall to get staff into trouble, or actually fall deliberately. See Tr. at 297-98 (Gray). Koester did not point to any documentation in his assessments or care plan of this behavior. There was testimony, however, that medication he was on might have affected his ability to maintain balance, so that his propensity to fall may also have reflected medical causes. Tr. at 82.

In either case, it is clear that the facility was aware that he was a falling risk and that he had seriously injured himself in frequent falls in the past; in response, Koester had implemented a number of measures at various times. These measures included the use of a Posey body alarm. However, before the fall in question, the alarm was discontinued at the resident's own request. The facility contends that "[c]ontinuation of that device would have been improper absent resident's consent." P. Br. at 18.

We conclude that the standard imposed by the regulation - that each resident must receive adequate supervision and assistance devices to prevent accidents - was not met by the facility. The facility did monitor this resident frequently, and was aware of his troublesome behavior with regard to falls; nevertheless, the facility did not point to anything in the record to demonstrate that it supplemented or replaced the use of the warning alarm with effective measures to prevent further falls. It is simply unacceptable to abdicate the duty to supervise or use assistive devices to prevent falls even when the resident, for whatever reason, is resistant, noncompliant, or difficult to deal with. We hold, instead, that compliance with the standard involves consideration of a variety of measures designed to prevent a resident from falling. When an individual like R. 134, whose diagnosis includes cognitive impairment, who frequently falls or threatens to fall, and who has a history of injuries from falls is in the care of the facility, the facility must take appropriate steps to prevent falling accidents from occurring whether or not the individual's actions can be termed "deliberate" given his mental status. Where an individual refuses a particular protective device (here, the body alarm), the facility is still responsible under 42 C.F.R. § 483.25(h)(2) for protecting the safety of that person. If the device is to be removed, the facility is obliged to provide another means of supervision or assistance to prevent falls. See generally DAB No. 1726, at 34 (2000).

In short, while there is no dispute that the resident had a right to refuse treatment, the facility had a countervailing duty to protect the dependent individual under its care against accidents. Certainly, if the facility was sufficiently aware of the resident's proclivity for falling to have installed an alarm to begin with, then appropriate alternative measures should have been put in place if the body alarm was discontinued.

The ALJ's conclusion that Koester complied with 42 C.F.R. § 483.25(h)(2) in its treatment of R. 134 is reversed.

D. We conclude that Koester was not in substantial compliance with 42 C.F.R. § 483.25(h).

We conclude, as to the accident prevention deficiencies, substantial evidence in the record supported the ALJ's findings that Koester complied with the regulations as to one resident. However, we conclude that her finding to the same effect as to a second resident is not supported by substantial evidence. Rather, as to the second resident, the record shows that Koester did not take appropriate measures to prevent falls. Therefore, we vacate the ALJ's FFCL No. 9 and replace it with the following substitute FFCL No. 9:

The provider was not in substantial compliance with 42 C.F.R. § 483.25(h)(2), a quality of care requirement to ensure that each resident receives adequate supervision and assistance devices to prevent accidents.

3. The ALJ's conclusion that Koester was in substantial compliance with 42 C.F.R. 483.25(c) is not supported by substantial evidence in the record.

The pressure sore regulation has two prongs, both of which are relevant to the deficiency findings here. First, section 483.25(c)(1) provides that each facility must ensure that any resident who does not have pressure sores on entering the facility does not develop any while there "unless the individual's clinical condition demonstrates that they were unavoidable." Second, section 483.25(c)(2) provides that the facility must ensure that any resident who does have pressure sores "receives necessary treatment and services to promote healing, prevent infection and prevent new sores from developing."

In assessing the level of noncompliance relating to pressure sores, the surveyors explained in the Form 2567 as follows:

Failure to provide adequate skin care resulted in pressure sores for 4 residents. Inadequate skin care results in pain and discomfort to the resident and possible infection. This was isolated to one unit with harm that was not jeopardy.

P. Ex. 30, at 26. The surveyors found that two residents (known as R. 24 and R. 44) who entered the facility without pressure sores had developed them while at the facility. P. Ex. 30, at 29. They determined that the causes were avoidable, specifically that they were caused by wearing inappropriate shoes. Id. A third patient (R. 30) suffered from diabetes and vascular disease and had one leg amputated. Id. at 30. The surveyors found that he had developed a pressure sore on the heel of his remaining foot. The surveyors observed that he had been wearing a new "pressure boot" and that dried substances were noted on the padding when the boot was removed. Id. Finally, a fourth patient (R. 8) had a pressure sore on her buttocks and a surveyor observed this resident left with fecal matter in the area after toileting. Id. at 31.

We address first what standard applies to the evaluation of facility compliance with the participation requirements relating to pressure sores. We then discuss the specific findings about the four individual residents. In three instances, we conclude that the ALJ's factual findings regarding the provider's treatment of the residents' pressure sores do not support her legal determination that the provider was in compliance with this quality of care standard. In relation to R. 30, however, we conclude that substantial evidence supports the ALJ's finding that the pressure sore at issue was unavoidable.

A. The regulations require that a facility ensure that requisite services are received.

The standard on which the ALJ appeared to rely in finding that Koester was in substantial compliance with this provision, as with the preceding one, seemed to turn on whether the facility had done what the ALJ considered to be "everything within reason." See, e.g., ALJ Decision at 18, 22. Again, this phrasing does not make clear whether the ALJ considered the evidence in light of the correct regulatory standards. See HCFA Br. at 19, 22.

In meeting this particular requirement, the facility must ensure no resident develops pressure sores unless clinically unavoidable and that any resident with pressure sores receives necessary treatment and services for healing, preventing infection and preventing future sores, in order for the facility to meet the overall quality of care requirement to provide what is necessary for each resident to "attain or maintain the highest practicable . . . well-being." 42 C.F.R. § 483.25.

In the preamble to the final regulations, HCFA noted that some commenters sought to have the term "ensure" replaced with less demanding language such as "provide" or "enable." They argued "that a facility cannot reasonably be expected to 'ensure' that a desired outcome will occur, especially with respect to all of the factors that may affect frail, aged nursing home residents." 56 Fed. Reg. 48826, at 48850 (Sept. 26, 1991). HCFA responded that -

As we noted in our discussion of this issue in the preamble to the February 2, 1989 final rule (see 54 FR 5332), resident care outcomes can sometimes be affected by factors other than the treatment and services furnished, such as the degree of a resident's cooperation (i.e., the right to refuse treatment) and disease processes. However, we do not believe it is unreasonable to make the facility responsible for ensuring that basic treatment and services are provided since this is the reason for the resident's stay in the facility, as well as for program payment. We believe that the current wording of this section acknowledges the limitations imposed by the resident's right to refuse treatment, as well as by recognized pathology and the normal aging process, by enabling the facility to demonstrate that based on available clinical evidence, a negative resident care outcome was unavoidable.

Id. The preamble further stated that the expectation in the regulations was that a "facility should always furnish the necessary treatment and services to prevent the development of pressure sores or, at the least, to promote the healing of sores that have developed." Id. at 48851.

We therefore review the conclusions relating to pressure sores in light of the regulatory standard that a facility should go beyond merely what seems reasonable to, instead, always furnish what is necessary to prevent new sores unless clinically unavoidable, and to treat existing ones as needed.

B. The ALJ's finding regarding the pressure sores developed by R. 44 is not supported by substantial evidence and is based on an erroneous interpretation of the regulatory requirements.

The ALJ found that R. 44 had no pressure sores on admission to the facility and then developed pressure sores as a result of wearing shoes provided by her family. ALJ Decision at 18-22. HCFA contended, through its surveyors and in its brief, that the facility was obligated to intervene whenever a situation is likely to cause the development of pressure sores. Tr. at 176, 195-6; HCFA Br. at 17. One of the surveyors, Ms. Tobias, stated that since pressure sores can be caused by unrelieved pressure on a resident's skin, new shoes should be avoided, especially for high risk residents who are dependent on the staff for daily needs. Tr. at 176, 195-96.

As the ALJ found, Resident 44 suffered from ALS (amyotrophic lateral sclerosis), had had a prior stroke, had aphasia, was limited in mobility and was totally dependent on the staff for all her care. All of these conditions placed her at high risk for pressure sores. ALJ Decision at 19.

The resident's daughter preferred for the resident to wear a certain pair of shoes that had been brought in by the family because they were the "style of shoe she had always worn." Tr. at 257 (Stine), 326 (Wiley). According to Ms. Stine (a licensed practical nurse at Koester), the family was informed that "they no longer fit her feet right because her feet were showing some contracturing from her disease process." Tr. at 257. Ms. Wiley called the daughter and said that the shoes had caused a red area and asked that she bring in a larger size. The facility waited several days and then put properly-fitting tennis shoes on the resident. Tr. at 326. When the daughter next visited, she took home the tennis shoes, because she felt her mother would never have worn them, and replaced them with the ill-fitting shoes, which were the type her mother had "always worn" as a dancer "in her younger days." Tr. at 327-28. Clearly, thus, Koester's own witnesses establish that the facility staff knew that these shoes were medically inappropriate for the resident's condition and had already shown that they presented a danger to her skin integrity. Tr. at 326-28, 339-40 (Wiley). If shoes provided by family members were "too small" and required a "breaking in" period, as the nurses testified that these would, then it seems unlikely that such shoes could be suitable for an individual with a medically-caused proclivity towards pressure sores. See Tr. at 339-40. The staff asked the daughter twice over ten days to bring in different shoes, but she did not. See Tr. at 200 (Tobias).

At this juncture, the staff complied with the daughter's wishes and regularly put the shoes the daughter had provided on the dependent resident, even though they had already observed that the shoes caused a persistent area of skin redness (the essential definition of a Stage 1 pressure sore for the minimum data set assessment). See, e.g., P. Ex. 74 at 19. An open blister followed soon after. P. Ex. 74, at 35. The facility considered having a podiatrist determine the footwear needs of R. 44, but no such evaluation occurred until after the development of the blister in question. P. Ex. 74, at 35.

The ALJ concluded that the provider was in substantial compliance with the standard. ALJ Decision at 21-22. We disagree. The facility is not simply absolved of responsibility for providing the care needed to prevent pressure sores by the family's wish to see their relative dressed as she had always been. That would be inconsistent with the regulatory purpose discussed above. The ALJ erred in considering treatment or action taken by a facility after a pressure sore has been allowed to develop as an adequate substitute for the prevention of sores from the start. The regulation requires that the facility ensure that pressure sores do not develop, unless clinically unavoidable. The facility did not contend that this pressure sore was clinically unavoidable. The Board has previously held that a facility must provide all necessary care and services to prevent the development of pressure sores, rather than just provide prompt treatment after they develop, particularly where the residents involved were known to have a high risk of developing sores. See DAB No. 1665.

While it is understandable that a facility would wish to accommodate the preferences of a resident or his/her family members, the facility has an obligation under the regulations to take any necessary precautions to prevent pressure sores. Certainly, the facility cannot shift the blame for its inaction to the daughter not providing different shoes at their request. The facility should accommodate the family's preferences as much as possible, but must still take necessary measures to prevent the predictable consequence of pressure sores. Such measures might have, for example, included a prompt medical evaluation, consultation with a podiatrist about shoe types that might minimize risk while preserving some of the appearance important to the family, allowing the resident to use slippers or other informal footwear whenever possible, or investigating methods of stretching or padding the shoes to avoid injury. With respect to R. 44, there is no evidence that any precautions to prevent pressure sores were taken, once the daughter removed the tennis shoes.

Clearly, the facility itself did not believe that its overriding legal duty was to please the family members. After the first red area developed, the facility had put on the tennis shoes even though the daughter had expressed her strong preference for the new shoes. After the blister finally developed, the facility stated that "preventive interventions were undertaken including providing slippers . . . and moon boots to prevent progression of the sore." P. Br. at 15. If such interventions were appropriate after the blister, appropriate measures should have been instituted from the point where the facility had assessed the risk to skin integrity presented by the new shoes.

We conclude that HCFA established its prima facie case by showing that R. 44 did not have pressure sores upon entering the facility, but subsequently developed such sores. Koester, therefore, had to show that the development of these sores was clinically unavoidable in order to sustain its burden of proof, not merely that the sores were later treated. No such showing was made by the facility. We therefore reverse the ALJ's conclusion that Koester was in substantial compliance with the regulations in its care of R. 44, both because her finding that Koester had done everything reasonable was not supported by evidence in the record as a whole and because, under the correct regulatory standard, the facts established show that the pressure sore was not unavoidable given proper care.

C. The ALJ's legal conclusion regarding the treatment of R. 8 is erroneous.

One surveyor (Ms. Grimes) recorded the following episode in R. 8's care observed during the survey:

[The surveyor and nurse entered the room for a dressing change. Two aides were leaving the room, at which time, it was stated that the resident had used the bathroom; they had completed her incontinent care; and the resident was resting in bed. When the resident was turned on her side to remove the old dressing, the resident's buttocks and lower back were soiled with stool. After washing the buttocks and lower back the nurse removed the soiled dressing.

P. Ex. 30, at 31. It is undisputed that this resident had a pressure sore in the area where the fecal matter was present, and that she was not properly cleaned until the attending nurse dressed the sore. ALJ Decision at 23.

HCFA argued that this resident was thus improperly cleaned after toileting, so that fecal matter was present at the site of a pressure sore. Given R. 8's serious illnesses (including cancer and peripheral vascular disease), this treatment both increased her risk of a new pressure sore and exposed the existing one to possible infection. HCFA Br. at 18. Koester argued that this resident was too large and unstable in balance, to be safely cleaned on the toilet, so that aides would finish cleaning her in bed. P. Br. at 16. Koester contended that it would have made little difference to have completed the cleaning because the nurses arrived at that point to change the dressing in that area, which was water-tight, and therefore protected the pressure sore from contact with the fecal matter. Id.

The ALJ found the following facts, based on the testimony received at the hearing:

•Witnesses for both parties agreed that the nurse aides were able to clean the skin area around the sores, although they were not permitted to change the dressing.

•They further agreed that there was no reason for the aides not to clean the area and that "good nursing practice" included such cleaning, even if the imminent arrival of a nurse to change the dressing is anticipated.

•Koester's practice was "for nurse aides to clean a resident who has soiled herself and tell the charge nurse that the dressing is soiled and needs changing."

•The surveyor was present for the arrival of the nurse and was informed by the aides that they had completed R. 8's incontinent care and returned her to bed.

•When the nurse arrived, the aides turned the resident over for the nurse to change R. 8's dressing.

•It was "poor nursing practice" to leave R. 8 in this "degrading and unsanitary condition."

ALJ Decision at 23-24 Nevertheless, the ALJ concluded that this incident did not actually harm R. 8, because the existing pressure sore was protected by the dressing and the fecal matter was not in contact with skin areas long enough to contribute to any new pressure sores. Id. at 23. Further, the ALJ held that this was an isolated omission which was quickly attended to by the nurse. The ALJ held that, under these circumstances, she did not find any deficiency, especially since HCFA failed to show that it was a regular practice of the facility "to leave residents with fecal matter clinging to their skin." ALJ Decision at 24.

The ALJ found substantial compliance largely because the incident was isolated, and the resident was not actually harmed. She nevertheless suggested that she would have found that leaving residents in this condition without promptly cleaning them would "clearly . . . constitute a deficiency," without indicating that such a finding would require proof of actual harm occurring to the residents. Cf. ALJ Decision at 24. Indeed, it is clear that the potential for causing more than minimal harm is sufficient to demonstrate a failure of substantial compliance under HCFA's regulations, without a finding of actual harm. 42 C.F.R. § 488.404(b)(2) (emphasis added). Further, an isolated incident, if serious enough, may indicate problems in the facility since a survey can only be a sample of facility conditions, especially given that this deficiency would not necessarily have been detectable in a record review. Lake City Extended Care Center, DAB No. 1658, at 14-15 (1998) ("[T]he regulatory scheme . . . 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."). It is also clear that noncompliance exists even in the case of an isolated problem, where the findings involve more than a potential for minimal harm, though a pattern of such practices indeed may justify finding a higher level of noncompliance. 42 C.F.R. § 488.404(b)(2); 42 C.F.R. § 488.301 (substantial compliance means no deficiencies posing risk greater than the potential for minimal harm).

Substantial evidence supports the ALJ's finding that no harm actually occurred here because the dressing did not leak and the delay in cleaning was brief. However, the ALJ did not make any finding that the potential for more than minimal harm was absent too, nor did she explain why she ignored ample testimony in the record that the presence of fecal matter near a pressure sore in a patient already at high risk for sores increased the risk of developing infection or new sores in the area. See, e.g., Tr. at 233, 238 (Grimes).

We thus conclude that the facts found by the ALJ do not support her conclusion that no deficiency was present. Under the legal standard for assessing compliance with requirements for preventing and treating pressure sores, the factual findings, and the record evidence as a whole, established that Koester was not in substantial compliance with this provision.

D. The ALJ's finding regarding the pressure sore developed by R. 30 is supported by substantial evidence.

With respect to R. 30, the ALJ concluded that the provider properly cared for this resident's pressure sores. ALJ Decision at 23. R. 30 had diabetes and vascular disease. Id. at 22; Tr. at 269; P. Ex. 72, at 68. Because his disease process had caused and was likely to cause pressure sores and damage to his feet, he was fitted with a special pressure boot by a physical therapist. Tr. at 224, 363; P. Ex. 72, at 33. When the surveyors observed this resident, they felt that an unusual bend in the boot had caused development of a pressure sore in its vicinity. Tr. at 223 and 362-63 (Grimes). They also observed that a substance of some kind was present in the lining of the boot, which caused them concern. Tr. at 220 (Grimes).

Koester offered testimony, which the ALJ found credible, that --

•the substance discovered by the surveyors in his boot was actually an ointment designed to prevent pressure sores,

•the boot was designed by occupational therapists as part of R. 30's ongoing care by a podiatrist, Dr. Bailey,

•the sore that did develop was not related to his new boot, and

•instead, the sore was clinically unavoidable as a result of the disease process that had already cost R. 30 his other leg.

Tr. at 269-74 (Stine); P. Ex. 72, at 33. Unlike the situation discussed above, where inappropriate new shoes were provided by family members, the footwear here was prescribed precisely in an effort to prevent pressure sores in a high risk situation. Id. We defer to the ALJ's assessment that the witnesses on this question presented by Koester were more credible. Hence, we agree that in this instance the facility took all appropriate precautions, and that the pressure sore in question was not preventable.

The ALJ's findings are thus supported by substantial evidence and her conclusions of law are appropriate.

E. The ALJ's findings regarding the pressure sore developed by R. 24 are supported by substantial evidence.

With respect to R. 24, the ALJ's conclusion that the facility was in substantial compliance with the pressure sore regulation is supported by substantial evidence. While R. 24, like R. 44 (see discussion in Part B, above) did not develop pressure sores until after her arrival at the facility, the ALJ found, and the record establishes, that R. 24's sores were in fact unavoidable, and that the facility used all proper means to prevent the sores, as well as to treat them after they developed.

R. 24 was known to have very fragile skin and to be at risk for skin tears. As with R. 44, R. 24 was provided shoes by her family which resulted in the development of blisters. Here, however, the residents' situations diverge. The facility had used slippers for this resident. These shoes were provided at the request of the resident's podiatrist, and were specifically intended to allow relief from the pedal edema that resulted from R. 24's circulatory ailments. Tr. at 254-55 (Seine), 324-25 (Wiley). Further, the shoes were adjustable, were not observed to be ill-fitting, were monitored by the facility when a blister or red area developed, and were thereupon promptly removed. Tr. at 325-26, 338 (Wiley).

Given that the facility relied on the expertise of the patient's treating physician (the podiatrist in this instance), carried out his directives, and took other steps to monitor and treat the resident's condition, the ALJ's determination that the facility was in compliance is supported by substantial evidence. See DAB No. 1745, at 11; Beverly Health and Rehabilitation-Spring Hill, DAB No. 1646, at 44 (1999). In contrast with its actions concerning R. 44, where the facility allowed the resident to wear footwear which it knew was not proper for her skin sensitivity, the actions of the facility were proper with regard to R. 24.

F. We conclude that Koester was not in substantial compliance with 42 C.F.R. § 483.25(c).

We conclude, as to the pressure sore deficiencies, two out of four instances cited by the surveyors demonstrate a failure by the facility to ensure that pressure sores do not develop or to properly treat existing pressure sores. Therefore, we vacate the ALJ's FFCL No. 10 and replace it with the following substitute FFCL No. 10:

The provider was not in substantial compliance with 42 C.F.R. § 483.25(c), a quality of care requirement for prevention and treatment of pressure sores.

4. The proposed penalty of $50 per day for 50 days of violation is appropriate.

While we have affirmed the ALJ in overturning the finding on which immediate jeopardy was based, as well as her findings that the facility was not in violation of the cited regulations with respect to R. 30 and R. 24, we have found that Koester nevertheless was not in substantial compliance during the 50 days. Since the amount of the penalty proposed for that period was the minimum amount provided in the regulations, there is no reason to remand this case to the ALJ. Under HCFA's regulations, the ALJ and this Board, having found that a basis for imposing a CMP exists, have no authority to "[s]et a penalty of zero or reduce a penalty to zero." 42 C.F.R. § 488.1348(e). We therefore reinstate the proposed penalty without remand. We vacate the ALJ's FFCL No. 11, and substitute the following FFCL:

FFCL No. 11. The provider was not in substantial compliance with Medicare participation requirements, and HCFA is authorized to impose a CMP of $2,500.

Donald F. Garrett

M. Terry Johnson

Marc R. Hillson
Presiding Board Member

1. The surveyors reported their findings in a Statement of Deficiencies on HCFA Form 2567L and cited each deficiency in compliance with a participation requirement by an "F Tag" number corresponding to a particular regulatory provision. See P. Ex. 30; see also HCFA Ex. 3. The 2567L was revised, and unless otherwise specified, our discussion refers to the later version which is in the record as Petitioner Exhibit 30 (which also contains Koester's Plan of Correction responding to the deficiency findings). Each deficiency was evaluated on a scale that reflected the scope and severity of the problem, from those that presented no risk beyond the potential for causing minimal harm to those that presented immediate jeopardy to resident health or safety.

2. HCFA misnumbered FFCLs Nos. 9 and 10, but quoted the language so it is clear that these are the FFCLs to which HCFA excepted. Cf. HCFA Br. at 16, 20. HCFA did not name an exception to FFCL No. 11 but its arguments necessarily imply an exception to the ultimate conclusion.

3. As mentioned above, we discuss why we defer to the ALJ's determinations on witness credibility issues in detail in the next section. For purposes of this discussion, we address whether substantial evidence exists in the record as a whole to support the findings, given the testimony credited by the ALJ.

4. In any case, it is not obvious that the two descriptions are necessarily inconsistent. It is entirely possible to visualize a patient whose waist is immobilized except for pivoting from side to side on an linear axis but who can nevertheless (given sufficient physical strength) bend at the waist to swing arms or legs in either direction.

5. It appears that the reference to the side rails as ½ to 3/4 length was based on these dimensions, being roughly 3/4 the length of full side rails and ½ the length of the bed. ALJ Decision at 7.

6. HCFA bolstered the surveyors' testimony about the high risks of using anything less than full-length bed rails by pointing out that Ms. Davis had once witnessed an entrapment involving less than full-length bed rails. HCFA Br. at 8, n .2. However, Ms. Davis testified that the resident in the situation she witnessed was caught in the space between the top half of a side rail and the headboard of a bed. Tr. at 38. Here, however, there was no suggestion that R. 113 could possibly have moved from his position about 21 inches below the headboard in the center of his bed and then have squeezed through the two inches between this side rail and the headboard.

7. In the Statement of Deficiencies, the surveyors had observed that R. 113's bed "had the top rails of a split rail system up" and "the bottom split rails were not on the bed." P. Ex. 30, at 32. However, at the hearing, as noted above, the surveyors agreed with Koester staff that the side rail system used for R. 113 resembled one shown in photographs of the partial length rather than the two-piece split rail variety. See Tr. at 121-22; P. Ex. 76, at 2, 7.

8. We note that it was undisputed that the relevant manufacturer was Posey Company, which produced the waist restraint. The manufacturer of the side rails submitted a statement that it did not publish guidelines on the use of its side rails with restraints, deferring rather to the restraint manufacturer, but also asserted that it had received no "complaints regarding the use of siderails with properly applied restraints." P. Ex. 30, at 32 and 79; ALJ Decision at 8, n.5.

9. Koester submitted with its Plan of Correction a version which warned that -

All siderails MUST be in the up position when using restraints. If necessary, use a siderail cover, especially with split siderails, to prevent the patient's body from going under, around, through, or between the siderails.

P. Ex. 30, at 77. As the ALJ noted, this version also contains no requirement to use full side rails or rail covers in all cases. ALJ Decision at 10-11.

10. This question never received a response, however. See Tr. at 117-21; P. Br. at 9-10.

11. This resident is also referred to in places in the record as R. 43 and R. 131, but the parties do not dispute the resident's identity. ALJ Decision at 12, n.8.