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CASE | DECISION | ANALYSIS | JUDGE | FOOTNOTES

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


SUBJECT: Josephine Sunset Home,

Petitioner,

DATE: February 9, 2004

             - v -

 

Centers for Medicare & Medicaid Services

 

Docket No. A-03-85
Civil Remedies CR103
Decision No. 1908
DECISION
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FINAL DECISION ON REVIEW OF
ADMINISTRATIVE LAW JUDGE D
ECISION

On July 11, 2003, Josephine Sunset Home (Sunset) appealed the May 12, 2003 decision of Administrative Law Judge (ALJ) Steven T. Kessel sustaining the determination of the Centers for Medicare & Medicaid Services (CMS) to impose on Sunset a denial of payment for new admissions (DPNA) from June 15, 2002 through July 5, 2002, as well as the loss of approval for a nurse aide training program for two years. Josephine Sunset Home, DAB CR1038 (2003) (ALJ Decision). These remedies were imposed based on a survey which found that Sunset was not in substantial compliance with applicable requirements for participation in the Medicare program. The ALJ decided the case based on the written record after cross-motions for summary disposition, and concluded that CMS was authorized to impose the remedies. We conclude, for the reasons explained below, that the ALJ's findings are supported by substantial evidence in the record as a whole and that no prejudicial error existed. Therefore, we affirm the ALJ Decision, as modified below.

Background

The facts included in this discussion are not disputed. Sunset is a skilled nursing facility (SNF) in Washington State. Medicare's participation requirements for SNFs and other long-term care facilities are set forth in 42 C.F.R. Part 483. Compliance with Medicare participation requirements is verified through surveys performed by state agencies under contract with CMS. Survey results are reported in a "Statement of Deficiencies" (SOD). 42 C.F.R. 488.325(a). A "deficiency" is a failure to a meet a participation requirement in 42 C.F.R. Part 483. 42 C.F.R. 488.301.

A compliance survey was completed by the State survey agency in May 2002. The SOD from the May 2002 survey reported a number of deficiencies and concluded that Sunset was not complying substantially with Medicare participation requirements. "Substantial compliance" means a "level of compliance with the requirements of participation such that any identified deficiencies pose no greater risk to resident health and safety than the potential for causing more than minimal harm." 42 C.F.R. 488.301. "Noncompliance" in turn means "any deficiency that causes a facility not to be in substantial compliance." Id.

CMS found that Sunset had achieved substantial compliance on July 5, 2002 and imposed a denial of payment for new admissions (DPNA) from June 15, 2002 to July 5, 2002. CMS also notified Sunset that it had lost the approval to operate a Nurse Aide Training and Competency Evaluation Program (NATCEP). Both the statute and the regulations prohibit any facility that has been subject to a DPNA from operating a NATCEP. Section 1395-i(f)(B)(iii)(I)(c) of the Social Security Act; 42 C.F.R. 483.151(b)(3)(ii).

The parties agreed that, although other deficiencies were cited on the SOD, only those involving two participation requirements, relating to pressure sores and accident hazards, formed the basis for the imposition of the remedies and remain at issue before us.

ALJ Decision

The ALJ decided this case on the written record without a hearing, after both parties moved for summary disposition. Counsel for Sunset filed a letter expressly stating that an in-person hearing was not needed and resting on the written submissions. Both parties submitted exhibits.

The ALJ made the following four numbered Findings of Fact and Conclusions of Law (FFCLs):

1. Petitioner failed to comply substantially with Medicare participation requirements.

a. Petitioner failed to comply substantially with the requirements of 42 C.F.R. 483.25(c).

b. Petitioner failed to comply substantially with the requirements of 42 C.F.R. 483.25(h).

2. Petitioner did not prove that it attained substantial compliance with participation requirements before July 5, 2002.

3. A basis exists to sustain CMS's remedy determination.

4. Petitioner's noncompliance with participation requirements is sufficient to justify its loss of nurse aide training authorization.

ALJ Decision at 3, 8, 11 and 12.

In reaching FFCL 4, the ALJ reasoned that Sunset lost its NATCEP authorization "as a consequence of CMS's acceptance of the scope and severity determinations made by the Washington State survey agency for the two deficiencies that are at issue in this case." ALJ Decision at 12. He went on to state that a facility will lose NATCEP approval if it manifests deficiencies establishing substandard quality of care as defined in the regulations at 42 C.F.R. 488.301. Id. He noted that, while a facility generally may not challenge the determination of scope and severity of a deficiency finding, "an exception to that rule is where a determination of substandard care is made which results in loss of nurse aide training authorization," citing 42 C.F.R.  498.3(b)(14)(ii). Id. Finally, he concluded that Sunset failed to rebut evidence supporting "CMS's determination that Petitioner's deficiencies showed a substandard quality of care" or to show that the deficiencies were "of a lesser scope and severity than that which was determined to be the case by CMS." Id.

Sunset's arguments on appeal

Sunset asked that the ALJ Decision be reversed on the grounds that it was contrary to law, contained an erroneous legal conclusion, and rested on findings of material fact that were not supported by substantial evidence. Sunset did not specifically identify the numbered FFCLs to which it excepted, but it is clear from the context of its argument that it excepted to all four FFCLs. Specifically, Sunset argued that, contrary to statements in the ALJ Decision, its loss of its NATCEP program was not based on a finding of "substandard quality of care," but rather was imposed by operation of law once the DPNA took effect. Sunset contended that none of the deficiencies was cited at the level required to find substandard quality of care and that no such finding was in fact made against it by the surveyors or by CMS. Sunset argued that one effect of the distinction was that it had not had any opportunity to challenge the scope and severity level of the two deficiencies at issue, being limited by regulation to challenging only the findings of noncompliance under 42 C.F.R.  498.3(b)(13). Hence, Sunset argued that it was also error for the ALJ to find that Sunset failed to prove that the deficiencies, if present, were of a lesser scope and severity than determined by CMS.

Sunset also challenged the ALJ's conclusion that it was not in substantial compliance.

Standard of Review

Our standard of review on a disputed conclusion of law is whether the ALJ Decision is erroneous. Our standard of review on a disputed finding of fact is whether the ALJ's finding is supported by substantial evidence on the record as a whole. See Guidelines for Appellate Review of Decisions of Administrative Law Judges Affecting a Provider's Participation in the Medicare and Medicaid Programs, http://www.hhs.gov/dab/guidelines/ prov.html.

ANALYSIS
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1. The ALJ's reference to substandard quality of care in the text of the ALJ Decision was harmless error.

In response to the appeal, CMS agreed with Sunset's points that "[s]ubstandard quality of care is not an issue here" and that the loss of the NATCEP was triggered by the DPNA going into effect. CMS Br. at 1, and n.1. In light of CMS's position, it is undisputed that the validity of the loss of Sunset's NATCEP depends entirely on whether the DPNA was authorized. It is also undisputed that CMS did not cite either deficiency at a level of scope and severity that constituted substandard quality of care.

To that extent, the ALJ's comment that the loss of Sunset's NATCEP was a "consequence" of CMS's accepting the scope and severity level of the deficiency findings, in conjunction with his discussion of substandard quality of care, was misleading. Sunset's NATCEP loss was the consequence of CMS accepting the findings that Sunset was not in substantial compliance, of CMS selecting a DPNA as the remedy to impose, and of Sunset failing to correct its deficiencies in time to avoid the DPNA going into effect.

Further, the regulations generally do not allow appeal of the level of scope and severity of the deficiency findings with limited exceptions. 42 C.F.R. 498.3(b)(13). As the ALJ noted, one exception is where a determination of substandard quality of care results in loss of NATCEP approval. ALJ Decision at 12; 42 C.F.R.  498.3(b)(14)(ii). That exception is inapplicable here because the loss of NATCEP approval did not result from any determination of substandard quality of care. The other exception is also inapplicable here. Hence, Sunset did not offer evidence to prove that any deficiencies present at the time of the survey "were of a lesser scope and severity than that which was determined to be the case by CMS," as the ALJ appeared to be requiring of Sunset, but such evidence would have been outside the scope of the ALJ's review in any case. See ALJ Decision at 12.

Nevertheless, while we agree with Sunset that portions of the ALJ's discussion in support of FFCL 4 were misleading, the actual FFCL language simply states that Sunset's noncompliance was sufficient to justify loss of its NATCEP. Assuming that the ALJ's conclusions that Sunset was not in substantial compliance and that CMS was authorized to impose a DPNA are supported by substantial evidence (which we discuss on the merits below), then it follows that the noncompliance was sufficient to lead to the loss of Sunset's NATCEP program. This is so because once a DPNA has been properly imposed, then by operation of law the facility loses its approval to operate a NATCEP. Section 1395-i(f)(B)(iii)(I)(c) of the Social Security Act; 42 C.F.R.  483.151(b)(3)(ii). In that sense, the noncompliance was indeed sufficient to justify the resulting NATCEP loss.

We therefore conclude that the ALJ's comments about substandard quality of care were indeed mistaken, but constituted harmless error. We affirm FFCL 4, as written, based on the analysis set forth above.

2. The ALJ's findings concerning pressure sores were supported by substantial evidence in the record as a whole.

Sunset's responsibility for the prevention and treatment of its residents' pressure sores derives from the following regulation:

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).

In reaching FFCL 1.a, the ALJ found that Sunset allowed two residents to develop pressure sores that were not clinically unavoidable and failed to provide necessary services to promote healing, prevent infection and prevent new sores, contrary to the provisions of 42 C.F.R. 483.25(c). ALJ Decision at 3. The ALJ held that the development of new pressure sores was prima facie evidence of a violation absent proof that the sores were unavoidable, citing Koester Pavilion, DAB No. 1750 (2000). ALJ Decision at 5-6. The ALJ also held that the surveyors' observations of the residents demonstrated that devices intended to promote healing (heel protectors for one resident and a gel cushion for the other) were essential but were not being used consistently. Id. at 6-7. In addition, the ALJ found that Sunset did not track the progress of the sores on Resident 2 and did not adjust the medication for Resident 3 despite the worsening condition of that resident's sores. Id. at 7.

Sunset presented a statement from Rebecca J. O'Brien, R.N., its director of quality assurance, who questioned "the etiology" of Resident 2's blisters and suggested that Resident 3 actually had a mechanical injury wound rather than a pressure sore. ALJ Decision at 6. The ALJ rejected these contentions because they did not amount to a clear assertion that the sores were unavoidable and because they were inconsistent with the facility's own contemporaneous assessments of the sores. Id. at 6-7. Sunset also offered evidence of many interventions made to attempt to treat the sores. Id. at 7. The ALJ concluded, however, that such efforts did not alter the failure to provide needed care consistently. Id.

Sunset's arguments on appeal focused on two contentions. First, Sunset argued that the sores, if they were indeed pressure sores, developed by the two residents were clinically unavoidable. Second, Sunset argued that the residents were provided with appropriate and necessary care. These contentions overlapped because additional sores developed while treatment was already underway for others.

Prior Board decisions have interpreted "clinically unavoidable" to mean not just unsurprising given the clinical condition of the resident, but incapable of prevention despite appropriate measures taken in light of the clinical risks. See, e.g., Livingston Care Center, DAB No. 1871 (2003) ("a pressure sore can be considered unavoidable only if routine preventive care is provided," citing State Operations Manual (SOM), Appendix PP). The language of the regulation, quoted above, clearly calls for facilities to take necessary actions in the face of high-risk conditions in order to prevent new sores. The Board has articulated the resulting obligation as follows:

Thus, in the area of pressure sores, the facility bears a duty to "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." Koester Pavilion, DAB No. 1750, at 32.

Meadow Wood Nursing Home, DAB No. 1841 (2002).

On appeal, Sunset acknowledged that both residents developed new sores while in the facility, but argued that their multiple medical risk factors made pressure sores clinically unavoidable. Sunset Br. at 6-7. Nevertheless, according to Sunset, it undertook numerous measures to prevent sores. Id. at 7, 9-10. When Resident 2 did develop blisters on her left hip and on each of her heels, the facility alleged it implemented heel boots. Sunset cited the declaration of its expert witness, Dr. Thomas, who stated that no other treatment is effective for healing pressure sores on the heels. Id., citing P. Ex. 8 (Declaration of David R. Thomas, MD). Sunset argued that the treatment must have been effective since the sores did resolve. Id. at 8. According to Dr. Thomas, a study of the natural history of pressure ulcers in nursing home residents demonstrates that the time taken was not out of line with "epidemiological healing rates." Id. As to Resident 3, Sunset contended that the sore in the area between his anus and coccyx, which was present for more than four weeks around January 2002 and then reappeared in February 2002 and was still present at the May 2002 survey, showed "no overt worsening." Id. at 11. Sunset argued that it provided appropriate treatment, including nutritional and wound care consultations and several topical agents. Id. at 10-11. Sunset acknowledged that use of a gel cushion was ordered for Resident 3, but stated that the resident would not "remember to use his gel cushion, pillow, or Roho cushion provided by staff and could often remove any pressure relieving device when placed on his seat." Id. at 12.

Sunset listed a litany of approaches it identified for each resident to preventing skin breakdown and treating the sores which did develop. Sunset Br. at 6-7, 9. The lists largely overlapped and included special mattresses, incontinent briefs and care, moisturizer on dry skin, and assistance with eating. Id. Sunset asserted that Resident 2 also received a special diet, an exercise program for leg strength, repositioning every two hours, and use of a pad to reduce friction in turning and that Resident 3 received a soft diet. Id. at 6-7, 9. Sunset also noted that emphysema treatment required Resident 3 to sit up (rather than lying down which would have created less pressure). Id. at 9. Sunset cited, as its evidence that these services were provided, to resident care guides produced for each resident and to standard care protocols used for all residents. CMS Ex. 21, at 26-35, 45-47; P. Ex. 10, at 1-3, 5-7.

Sunset's arguments on appeal do not address the point emphasized by the ALJ, that is, that Sunset did not prove it took the steps that its own witnesses and records identified as necessary to the effective treatment of the residents' pressure sores. Thus, Sunset did not point to records or other evidence showing which services were actually provided to each of the residents or with what frequency and consistency they were actually provided. In particular, Sunset did not identify documentation that Resident 2 was repositioned frequently as planned, that Resident 2 wore heel boots at all times as planned, or that Resident 3 consistently had a gel cushion in place when seated.

The record contained resident care guides for Residents 2 and 3. CMS Ex. 21, at 26-35; CMS Ex. 28, at 33-39; P. Ex. 19, 1-4. The resident care guides are instructions (couched in the first person) to caregivers about the needs and preferences of a particular resident. They include some of the interventions listed by Sunset (although not all of them). Id. For example, the care guides for Resident 2 mention wearing heel boots "daily" to protect sensitive skin but do not make clear that they are to be on "at all times" as was recommended. Compare CMS Ex. 21, at 26-35, with CMS Ex. 28, at 5. The physical therapist recommended on May 20, 2002, that Resident 3 use a gel cushion which was provided for him "in w/c [wheelchair] & easy chair when possible" and that it might be necessary to also provide additional skin protection with another cushion. CMS Ex. 20, at 24. Yet, the resident care guides for Resident 3 did not instruct the aides about the use of a gel cushion. P. Ex. 19, at 1-4. A reasonable inference is that some of the interventions were not implemented consistently since the aides were not provided instructions to implement them as planned.

The pressure ulcer prevention policy (dated June 2002) was also cited by Sunset as evidence of its interventions and includes protocols for basic, low risk, moderate and strict pressure ulcer precautions to be applied to residents identified by means of a Braden Risk Assessment Scale. P. Ex. 10, at 1-3, 5-7. The existence of a policy in itself, however, does not suffice to establish which interventions were undertaken for each resident or whether the direct caregivers knew about and performed those interventions as planned for each resident.

Sunset argued, however, that its care should not be found inadequate based on the mere absence of documentation, since the regulations do not "prescribe the format or manner in which assessments must be recorded" and the absence of a record of the "use of heel boots does not prove that care was not provided." Sunset Br. at 4-5. The ALJ's conclusion that Sunset was not consistently providing the treatment that these residents required did not rest on the absence of documentation alone, however. The ALJ credited surveyor reports that Resident 2 was seen in bed more than once not wearing heel protectors and that Resident 3 was observed on five different days during the survey sitting without a gel cushion. ALJ Decision at 7; CMS Ex. 1, at 13-14; CMS Ex. 26, at 33. Thus, there was affirmative evidence in the record from which he could reasonably infer that the absence of regular documentation of the use of the prescribed devices meant that the staff did not consistently employ them. (1) ALJ Decision at 4-5; CMS Ex. 1, at 14-15. Sunset's own expert testified that the "standard treatment for heel ulcers is relief of pressure." P. Ex. 8, at 3 (Thomas Declaration). Furthermore, the use of heel boots was documented for some time periods by entering initials on a form and yet left undocumented for other time periods. See, e.g., CMS Ex. 28, at 19-22. This inconsistency further undermines any inference that the facility simply did not have a practice of documenting the continuous use of such devices.

As far as the absence of documentation of regular use of the gel cushion by Resident 3, Sunset did not contend that the cushion was actually in place consistently but simply not recorded in the documentation. Rather, Sunset offered an explanation for its failure to use the gel cushion to protect Resident 3 and promote healing of the sore on his coccyx. Sunset contended that the resident forgot, did not like, or did not understand the need for its use. See, e.g., P. Ex. 7, at 3. The same evidence also establishes, however, that staff was aware that the cushion was not being used. The wound care consultant repeatedly tried to encourage the resident to use it, but reported that he "would look at me and laugh and always said, 'I don't like it, it doesn't feel good.'" Id. The ALJ accepted that this might be true. ALJ Decision at 7. What the ALJ also found, however, was that Sunset itself had identified the need for pressure relief as essential, that the sore worsened over time in the absence of pressure relief, and that Sunset nevertheless undertook no alternative planning to assure that some pressure-relieving device would be in place when Resident 3 was seated (even though it was undisputed that his chronic pulmonary disease made it necessary for him to spend great amounts of time sitting). Id. The mere provision of a gel cushion is of no benefit if the staff knew it was not being used, and Sunset did not demonstrate that no practicable alternatives were available to it. We find that substantial evidence in the record as a whole supports the ALJ's conclusion that "[o]bservations that the residents were not provided the pressure-relieving devices that had been ordered for them is proof that [Sunset] failed to provide necessary care." ALJ Decision at 5.

Nothing which Sunset presented to us suffices to refute this central conclusion. For example, Sunset also contended, as noted, that the "wounds healed within better than expected healing rates based on epidemiological studies," from which Sunset inferred that necessary care must have been provided. Sunset Br. at 4, citing P. Ex. 8, at 3-4 (Thomas Declaration). Even assuming this to be true, it would not disprove that the wounds might well have healed more quickly if Sunset had consistently provided the appropriate devices. Similarly, even assuming that the other services and treatments listed by Sunset were provided consistently, the ALJ had substantial evidence to support the conclusion that the failure to assure that pressure relief was in place meant that Sunset had not done what was necessary to avoid, or promote healing of, pressure sores. In sum, the core problem identified at Sunset on this record was not with its policies or care planning but with the lack of consistent implementation of necessary care at the hands-on level of the individual residents.

As an overall matter, Sunset also strongly attacked the ALJ's reliance on expert testimony presented by CMS in the declaration of Courtney H. Lyder (CMS Amended Exhibit 32) and contended that the ALJ should have given greater weight to the declarations of two Sunset witnesses, Ms. O'Brien and Ms. Aundrea Pippel, who was a wound care consultant to Sunset (P. Exs. 6 and 7). Sunset Br. at 5. First, Sunset commented that Dr. Lyder "is not a physician as indicated by the ALJ." Id. It is clear that the ALJ was well aware that Dr. Lyder was not a physician but rather held a doctorate in nursing, both by the ALJ's reference to Dr. Lyder's professional degrees after her name and by the complete curriculum vitae in the record before the ALJ. ALJ Decision at 4; CMS Amended Ex. 32, at 29-46. In any case, neither of the witnesses Sunset relied on to contest Dr. Lyder's testimony were physicians themselves, and Sunset did not demonstrate that wound care expertise can be found only in physicians. (2)

Second, Sunset described Dr. Lyder's credentials as limited to being a registered nurse (R.N.) with certifications as a wound specialist dating to 1999 and as a gerontological nurse practitioner dating to 1991, and refers to her as "Mr. Lyder." Sunset Br. at 5. Sunset contrasted this background with Ms. O'Brien's "17 years of experience assessing and providing care for abnormal skin conditions and wounds" and Ms. Pippel's "21 years experience as a wound care specialist." Id. at 6. A fairer, and more complete, description of Dr. Lyder's background would include not only her R.N. licenses starting in 1989, and master's and doctoral level degrees in nursing, but also her tenured professorship at the University of Virginia Medical Center, among other academic appointments. CMS Amended Ex. 32, at 29-46. The curriculum vitae also reflects Dr. Lyder's clinical background and experience as a principal investigator on multiple research projects, and a lengthy list of publications relating to pressure sores in the elderly. Id. Sunset did not provide any basis to question Dr. Lyder's credentials.

Third, Sunset contended that its two nurse witnesses must be given great weight because, unlike Dr. Lyder, they had personally examined the residents. Sunset Br. at 6. The Board has held that, in some circumstances, if a qualified individual who cared for a specific resident over a long period of time testified in a manner consistent with documentary support that was complete, familiarity with a resident might be a reason to give more weight to the caretaker's testimony. Koester Pavilion, DAB No. 1750, at 15 (2000). The Board has also pointed out that "merely because some staff might generally be more familiar with residents, however, is not a reason to adopt a general rule requiring ALJs to give more weight to all testimony by staff members" and that, "in evaluating testimony, an ALJ may reasonably take into account factors such as witness qualifications and experience, as well as self-interest." Batavia Nursing and Convalescent Center, DAB No. 1904, at 26 (2004).

Sunset's fourth ground of attack on the ALJ's reliance on Dr. Lyder was that her credibility was "highly questionable" because she did not review the residents' clinical records in forming her opinions and had not personally examined either resident. Sunset ignored Dr. Lyder's supplemental declaration which asserted that she had reviewed Sunset's declarations and exhibits on pressure ulcer policy, resident progress notes, and resident care guides. CMS Ex. 35. Her supplemental declaration did not show any change in the opinions initially expressed, except to add direct responses to some of the arguments offered in Sunset's declarations. Since Dr. Lyder was explicit about the documents she reviewed in reaching her opinions as set out in each declaration, we see no basis for impugning her credibility. The ALJ was entitled to consider the fact that she did not personally observe the residents in determining what weight to give to her testimony, but was not thereby required to disregard her expert opinions as to the appropriate standards of care, as Sunset appeared to believe he should have done. It lay with the ALJ to determine what weight to give to the evidence before him. Sunset has not shown a reason for us to disturb the ALJ's assessment of the evidence.

Overall, we conclude that the record provides adequate support for the ALJ to credit the testimony of Dr. Lyder that the efforts undertaken by Sunset to prevent and treat pressure sores in Residents 2 and 3 were "substandard." ALJ Decision at 4. We also conclude FFCL 1.a was supported by substantial evidence on the record as a whole. We therefore sustain it.

3. The ALJ's findings concerning accident hazards were supported by substantial evidence in the record as a whole.

In reaching FFCL 1.b, the ALJ held that Sunset failed to comply substantially with the requirements in 42 C.F.R. 483.25(h) that the facility ensure that the residents' environment was as free of accident hazards as possible and that each resident received "adequate supervision and assistance devices to prevent accidents." Two incidents were cited under this tag, each of which involved a resident at high risk of falls whose bed lacked brakes on the wheels at the head of the bed. ALJ Decision at 8-11. The ALJ found that Resident 7 had a history of repeated falls from her bed before an incident on April 14, 2002 in which she fell into the space created when her bed rolled more than two feet from the wall against which it was placed. Id. at 8. The ALJ found that Resident 5 also had numerous falls prior to May 8, 2002, when a surveyor saw her on the floor. The resident was attempting to pull herself up holding a bar attached to her bed, which rolled toward her as she tried to rise. Id. at 9. The ALJ found in each case that the unlocked wheels on the bed presented a foreseeable hazard which the facility could have prevented by stabilizing the bed through brakes. Id. at 9, 11.

Sunset stated on appeal that its "entire argument, that it was in compliance with 42 C.F.R. 483.25(h), rests on its clearly stated position that a fall from the side of the bed that was against the wall was completely without foresight for either Resident # 5 or # 7 and that the bed did not cause the fall to occur for Resident # 5." Sunset Br. at 13. Sunset rested this argument on a line of Board decisions focusing on whether an accident was foreseeable and could have been prevented by reasonable measures. Id.; Asbury Care Center at Johnson City, DAB No. 1815 (2002); see also Koester Pavilion, DAB No. 1750, at 25-26 (2000); Woodstock Care Center, DAB No. 1726, at 25 (2000), aff'd, Woodstock Care Ctr. v. Thompson, No. 01-3889 (6th Cir. 2003).

These decisions held that 483.25(h)(2) does not impose strict liability. While section 483.25(h) "does place a high expectation on the facility to achieve results, . . . it does not "amount to strict liability or require absolute success in an obviously difficult task." Woodstock at 27. This means that the mere fact that an accident occurred does not, in itself, prove that the supervision or devices provided must have been inadequate to prevent it. In Woodstock, the leading decision on this topic, since upheld in court, the Board analyzed in considerable detail the relation between the requirement to ensure a safe environment and adequate supervision and assistance device to prevent accidents and the recognition that facilities can only be expected to do what is practicable. That analysis focused on the statutory objectives and the regulatory history of the requirements at issue, and we adopt it by reference here.

Sunset appears to have understood the Board's rejection of strict liability to mean that an accident must have previously occurred to the same person in the precise manner in order to attribute foreseeability to its repetition. A professional care facility can reasonably be expected to exercise more foresight than this. The Woodstock decision expressly rejected that facility's position that "it must somehow be provided advance warning of each adverse event in order to be responsible for taking reasonable measures to prevent injurious occurrences which it knows to be likely to take place at some point, if not at a particular time or place." Woodstock at 27 (relating to inadequate supervision); see also Odd Fellow and Rebekah Health Care Facility, DAB No. 1839 (2002) (relating to accident hazards, holding that a large hole in a floor caused by construction in a facility housing mobile judgment-impaired residents constituted a foreseeable accident hazard) and Batavia, DAB No. 1904, at 45 ("While Batavia might not have been able to foresee the specific incidents, Batavia could reasonably foresee that this resident was at risk, if not adequately supervised.").

Sunset also asserted, without citing any authority, that the "behaviors that contribute to or cause an accident to occur must be of a similar nature as those that have preexisted in order to avoid applying a strict liability standard." Sunset Br. at 13. Yet, there are many behaviors that are common and to be expected of residents with the kinds of impairments and risks shown by the two residents here, even if each individual resident had not previously engaged in each behavior. Interpreting the regulation to require a facility to take such behavioral repertoires into account in selecting appropriate equipment for the use of mentally-impaired residents at high risk of falls does not impose strict liability. Resident 7 was confused post-stroke and had fallen while trying to get out of bed multiple times over the preceding months. It did not amount to strict liability for the ALJ to conclude that the use of a bed with wheels that did not lock for such a resident presented a foreseeable hazard. Further, it was clearly possible to remove this hazard from the environment of this resident, either by using a bed that did not roll or using locks to prevent this bed from rolling. For a risk to be foreseeable, it need not have been made obvious by having already materialized. The regulation speaks in terms of ensuring that what is "practicable" and "possible" to do is done. What is thus required of facilities is not prescience but reason and professional judgment in assessing what can be done to make residents (given their special needs) safe, through removing accident hazards, providing appropriate devices, and ensuring adequate supervision.

For the same reasons, it is not persuasive to argue that Sunset could not predict that Resident 7 would try to rise from the floor by pulling on a bar attached to her bed. This resident too was confused, very unsteady, and had fallen many times, including at least two prior falls from her bed. ALJ Decision at 10. It was undisputed that the facility had installed the bed bar for the resident to use as a mobility aid in transferring from her bed and that guidance to the staff warned that the resident required reminders to lock her wheelchair brakes because of her memory deficits. Sunset Br. at 13-14; ALJ Decision at 10-11. Thus, the record provided substantial support for the ALJ's conclusion that "[l]eaving the bed on rollers and encouraging the resident to use the bed bar for support invited an accident because a potential existed for the bed to roll back against the resident any time the resident pulled on the bar." ALJ Decision at 11.

It is true, as Sunset argued, that the record does not establish whether the unlocked wheels on the bed contributed to this resident's fall, since the surveyor found her already on the floor and the fall was not observed. The relevance of the fall, however, is not that the rolling bed necessarily caused it, but that the resident's unsuccessful attempts to get up using the bed for support demonstrated that the bed had not been stabilized. This was still the case, even after the unsuitability of unlocked wheels on a bed for residents at high risk of falls and a history of trying to climb out of bed unassisted had been underlined by the accident involving Resident 7.

Finally, Sunset offered some evidence that the beds in question were heavy and that carpeting in the residents' rooms made them difficult to move. P. Ex. 6, at 6. Sunset did not argue that it assessed this risk at the time or that it had determined to use unlocked wheels in the beds of residents at high risk of falls from bed because it concluded that these beds were too difficult to move and therefore presented no risk. Rather, Sunset argued that it could not anticipate the potential that the Resident 7 would be strong enough to and would attempt to push the bed away from the wall so as to fall when the bed rolled. Sunset Br. at 13. It was within the ALJ's purview to determine whether to credit this after-the-fact explanation on behalf of Sunset for why the staff did not take notice of the possible hazards. Sunset did not provide any persuasive reason to disturb the ALJ's conclusion. In any case, the facility clearly knew after Resident 7's fall that the unlocked wheels on these beds were hazardous and could be moved by residents. Yet, as the subsequent events with Resident 5 make clear, the facility even then did not undertake any measures to re-assess the placement of high-risk residents in such beds.

We conclude FFCL 1.b was supported by substantial evidence on the record as a whole. We therefore sustain it.

Conclusion

Sunset offered no arguments that would justify reversing FFCLs 2 and 3, in light of our conclusions that FFCLs 1 and 4 are not erroneous and are supported by substantial evidence in the record as a whole. Therefore, for the reasons explained above, we affirm the ALJ Decision, with the modification discussed above, and sustain all the FFCLs.

JUDGE
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Cecilia Sparks Ford

Donald F. Garrett

Judith A. Ballard
Presiding Board Member

FOOTNOTES
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1. Sunset argued that the observations made by the surveyors occurred over too limited a time period to suffice as evidence of failure to provide necessary care. Sunset Br. at 4. As we note in the text, however, the ALJ could reasonably infer that the occasions on which these failures were observed by surveyors were unlikely to be the only occasions on which the devices were not provided to the residents as required by Sunset's own plans for their care.

2. As mentioned earlier, Sunset did proffer a declaration from Dr. Thomas as an independent expert. P. Ex. 8. Rather oddly, Sunset did not argue on appeal that the declaration of Dr. Thomas should have been given greater weight than that of Dr. Lyder. The two declarations did conflict, in particular about whether the wounds were allowed to worsen without adjusting treatment plans or whether in fact they healed as well as would be expected and alternative treatments were, in any event, unavailable. However, there was no conflict on the central point that pressure relief was the sine qua none of both prevention and healing.

CASE | DECISION | ANALYSIS | JUDGE | FOOTNOTES