SUBJECT: Harmony Court,

Petitioner,

Centers for Medicare & Medicaid Services

FINAL DECISION ON REVIEW OF
ADMINISTRATIVE LAW JUDGE DECISION

Harmony Court appealed the April 15, 2004 decision by Administrative Law Judge (ALJ) Anne E. Blair sustaining the determination of the Centers for Medicare & Medicaid Services (CMS) to impose civil money penalties (CMPs) totalling $77,100 for Harmony Court's failure to comply substantially with Medicare participation requirements. Harmony Court, DAB CR1164 (2004) (ALJ Decision).

As discussed below, we conclude that none of Harmony Court's arguments on appeal provides a basis for overturning the ALJ Decision. Accordingly, we sustain the CMPs imposed in this case.

Background

Harmony Court is a skilled nursing facility (SNF). SNFs participating in the Medicare program are subject to survey and enforcement procedures set out in 42 C.F.R. Part 488, Subpart E, to determine if they are in substantial compliance with applicable program requirements which appear at 42 C.F.R. Part 483, Subpart B. "Substantial compliance" means a level of compliance such that "any identified deficiencies pose no greater risk to resident health or safety than the potential for causing minimal harm." 42 C.F.R. § 488.301. "Noncompliance," in turn, is defined as "any deficiency that causes a facility to not be in substantial compliance." 42 C.F.R. § 488.301.

The Ohio Department of Health (State survey agency) conducted three surveys of Harmony Court - a complaint survey on November 5, 1999, a standard survey on January 19, 2000, and a revisit survey on March 10, 2000. The State survey agency found that the deficiencies identified in the first survey were corrected on December 10, 1999 and that the deficiencies identified in the second and third surveys were corrected on March 26, 2000. The results of each survey were reported in a Statement of Deficiencies (SOD). The deficiencies considered by the ALJ (as well as the remaining deficiencies based on which CMS imposed the CMPs) were assessed by the surveyors as Level D, E, F, or G deficiencies. See CMS Exs. 3, 12, and 31. ⁽¹⁾ Level D, E, and F deficiencies involve no actual harm with a potential for more than minimal harm that is not immediate jeopardy, and differ only with respect to their scope (isolated, pattern and widespread, respectively). Level G deficiencies are isolated in scope and involve actual harm that is not immediate jeopardy. CMS State Operations Manual (SOM), Appendix (App.) P, sec. V.

CMS notified Harmony Court that, based on the State survey agency's findings, it was imposing a CMP of $1,150 per day from November 5 - December 9, 1999 and a CMP of $550 per day from January 19 - March 25, 2000. Following a hearing, the ALJ concluded that Harmony Court had failed to substantially comply with 12 requirements of participation cited by the surveyors and that CMS did not prove that Harmony Court failed to comply with four participation requirements. ⁽²⁾ In addition, the ALJ found that "[t]he remedies imposed by CMS on Petitioner for its noncompliance found during the [three surveys] were reasonable." ALJ Decision at 44. The ALJ did not address in her decision all of the deficiency findings on which CMS relied since she found that the selected deficiency findings that she addressed and upheld "provide a sufficient basis to affirm the imposition of the remedies and the amounts of the CMPs." ALJ Decision at 6. ⁽³⁾

On appeal, Harmony Court takes exception to the ALJ's 12 findings of fact and conclusions of law (FFCLs) regarding its noncompliance with participation requirements (FFCLs A.1., A.2., A.3., A.4., A.6, B.1, B.3, B.4, B.5, B.6, B.7, and C.1) as well as with FFCL IV, regarding the reasonableness of the CMP amounts.

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.

We first address two legal issues raised by Harmony Court with respect to several of the ALJ's findings of noncompliance. We then proceed to discuss individually the FFCLs to which Harmony Court takes exception. ⁽⁴⁾

The ALJ did not apply the wrong burden of proof.

Harmony Court takes the position that the ALJ erroneously shifted the burden of proof to the provider in this case. Harmony Court argues that "requiring that a provider prove compliance by the preponderance of the evidence conflicts with the" Administrative Procedure Act (APA) and also that the "burden of proof standard" applied here "is a substantive rule" that was not promulgated pursuant to the notice and comment rulemaking procedures required by the APA. Request for Review at 4.

We reject Harmony Court's contention that placing the ultimate burden of persuasion on the facility to show substantial compliance violates the APA. As the Board has previously stated, the burden of proof that the Board applies is not a rule under the APA but instead is in the nature of an order setting forth a rationale that establishes precedent for ALJ hearings in these cases. See, e.g., Batavia Nursing and Convalescent Center, DAB No. 1904 (2004). Furthermore, while this rationale was originally set forth in Hillman Rehabilitation Center, DAB No. 1611 (1997), aff'd, Hillman Rehabilitation Center v. United States, No. 98-3789(GEB) (D.N.J. May 13, 1999), it has not been treated as a binding rule but has been reexamined as appropriate to different types of cases. In any event, as the ALJ correctly stated, "the burden of persuasion . . . applies only where the evidence proffered by both sides is 'in equipoise.'" ALJ Decision at 4, n.1. To the extent that the evidence in this case is not in equipoise, it is immaterial where the burden of persuasion lies.

Neither the absence of actual harm nor a dispute as to CMS's finding of actual harm is a basis for reversing a deficiency finding.

With respect to residents cited in several deficiency findings, Harmony Court argues that the deficiency finding should be reversed in the absence of any finding that the deficiency caused actual harm. ⁽⁵⁾ In addition, Harmony Court disputes the finding of actual harm that was made in certain other cases. ⁽⁶⁾ These arguments are unavailing. As indicated above, a facility is not in "substantial compliance" with a participation requirement if it is found to have a deficiency that results in actual harm to a resident or poses a risk of more than minimal harm to resident health and safety. 42 C.F.R. § 488.301. Thus, the absence of actual harm is not a basis for reversing a finding that a facility failed to substantially comply with a participation requirement. Contrary to what Harmony Court suggests, moreover, this conclusion is consistent with the outcome-oriented approach described in the preamble to the applicable regulations, which emphasizes resident care outcomes, rather than procedural and structural requirements. See, e.g., 54 Fed. Reg. 5316, 5332 (Feb. 2, 1989). As the Board has previously stated, "the outcome being looked at is the quality of care being provided, not just the health outcome for the individual resident." Spring Meadows Health Care Center, DAB No. 1966, at 19 (2005).

In addition, in this case, CMS's determination of actual harm is relevant only to the issue of the level of noncompliance (i.e., the scope and severity of the noncompliance) and review of that issue is limited. A facility is entitled to review of the level of noncompliance only when a successful challenge would affect either the range of CMP amounts that CMS could impose or a finding of approval of a nurse aide training program. 42 C.F.R. § 498.3(b)(14); see also 42 C.F.R. § 498.3(d)(10)(ii). Neither of those situations is present here.

FFCL A.1. Petitioner failed to comply with the requirement set forth at 42 C.F.R. § 483.25. ⁽⁷⁾

Section 483.25, captioned "Quality of care," states:

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

The ALJ found, with respect to the three residents cited by the SOD for the November 1999 survey, that Harmony Court "failed to provide necessary services to ensure the residents' highest practicable physical well-being." ALJ Decision at 7.

Resident 13: According to the SOD, Resident 13 had physician orders for use of a pelvic restraint at all times when in her geri-chair. ^{(8) (9)} The ALJ found that Harmony Court did not intervene to prevent Resident 13 from being injured by the pelvic restraint, which tightened whenever she scooted forward in her geri-chair and, according to nursing notes prepared a month before the survey, left red welts on the resident's buttocks. The ALJ stated that Harmony Court should have replaced the pommel cushion on the chair, which was so worn that it was ineffective, ⁽¹⁰⁾ "or tried some other intervention to relieve Resident 13's painfully tight restraint." ALJ Decision at 7-8.

On appeal, Harmony Court asserts that the ALJ "overlooks that Resident #13 was small of stature, very demented, very agitated and could not sit still" and that "she would constantly squirm out of whatever position she was in." Harmony Court further asserts that it tried "multiple interventions . . . including a geri-chair, wheelchair, beanbag, helmet, roll belt, pelvic restraint and alarms." Harmony Court argues that it should not be faulted simply because the interventions it had tried did not work to alleviate the problem with the restraint. Request for Review at 7-8, citing Tr. at 199-200 (emphasis in original).

Nothing Harmony Court raises in its request for review undercuts the substantial evidence in the record as a whole supporting the ALJ's conclusion that Harmony Court was not meeting the requirements of section 483.25. This evidence includes the evidence of actual injuries to the resident, the worn pommel cushion, and documentation that facility staff were aware that the resident was continuing to slip in her chair. Contrary to what Harmony Court argues, it is clear from the ALJ Decision that the ALJ considered the resident's agitation, viewing it as a basis for requiring an effective intervention by Harmony Court, not a basis for excusing the lack of an effective intervention. Moreover, it is simply irrelevant that Harmony Court had tried other interventions to help the resident with positioning or to prevent her from falling prior to using the pelvic restraint since the basis for the deficiency finding is not that the facility failed to take any steps to address such problems but rather that this particular intervention was itself problematic.

Resident 22: Resident 22 was taking a diuretic, Lasix, which can cause dehydration, which in turn can cause constipation or fecal impaction. The ALJ found that Harmony Court regularly gave Resident 22 a stool softener but failed to chart the resident's bowel movements for many shifts over a two-month period. The resident then experienced a fecal impaction. The ALJ stated that, without regular checking and charting, the facility's staff could not determine that further services were necessary to prevent a fecal impaction. ALJ Decision at 10.

On appeal, Harmony Court argues that the ALJ should not have faulted the facility "for failing to prevent a [single] instance of fecal impaction" for this resident since "routine monitoring of her bowels and bowel movements and a routine stool softener . . . were utilized by the facility." Request for Review at 8. Harmony Court did not, however, dispute the substantial evidence in the record relied on by the ALJ in finding that Harmony Court's assertion of routine monitoring was not supported by facility records (which showed that monitoring was not charted for many shifts). ALJ Decision at 10, citing CMS Ex. 10, at 14-16.

Harmony Court also appears to argue that it was not required to monitor the resident's bowel movements because "the resident's care plan was silent on interventions for constipation." Request for Review at 8. The Board has previously said, however, that the general requirement in section 483.25 that care provided to residents accord with their assessments and care plans does not limit a facility's duty to provide quality care to addressing needs spelled out in a resident's formal comprehensive assessment where other needs become evident after that assessment. See, e.g., Spring Meadows Health Care Center, DAB No. 1966, at 17 (2005); Alden-Princeton Rehabilitation & Health Care Center, DAB No. 1873, at 7 (2003). Here, the resident's Minimum Data Set Basic Assessment Tracking Form dated September 12, 1999 shows an order for Pericolace, a laxative, once a day. P. Ex. 8, at 12. Harmony Court's former MDS restorative nurse testified that Pericolace is not always effective. Tr. at 233. Since Harmony Court had a form for monitoring the resident's bowel movements, the ALJ could reasonably conclude that Harmony Court was aware that there was a need to monitor the resident's bowel movements to see if the Pericolace was effective. Thus, the mere fact that Harmony Court did not specify in the resident's plan of care that the monitoring would be done is not sufficient to show that failure to do the monitoring regularly did not constitute a failure to meet the requirement in section 483.25.

Resident 12: Resident 12 had a long history of scratching herself, causing injuries. Several days prior to the survey, her physician ordered Atarax for itching and a spray to be applied to her buttocks as needed after incontinence care, but the scratching continued. During the survey, the resident was observed in bed without pants or an incontinence brief for over an hour and was also observed scratching herself on her buttocks with "long jagged fingernails." Noting that a nurse testified for the facility that staff did not put a diaper on Resident 12 while she was in bed in order to keep her skin dry and help stop the itching, the ALJ stated that "[w]hile dryness may help heal an area already injured, it is counterintuitive to think that leaving Resident 12 without undergarments for an hour would help her skin, given her inclination to scratch." The ALJ also noted that following the survey, "an order was issued including directions to leave diapers on Resident 12 when she was in bed." The ALJ concluded that Harmony Court "had the responsibility to keep the areas [the resident] scratched covered and her nails trimmed so she would not endanger her skin." ALJ Decision at 10-11.

On appeal, Harmony Court takes exception to the ALJ's characterizing as "counterintuitive" its belief that leaving the resident without undergarments would help her skin. Harmony Court states that "no evidence was cited that what the facility was trying to accomplish was wrong or that its means were proscribed at the time the surveyor made her observations." Request for Review at 9.

The ALJ's conclusion that the care provided to Resident 12 did not meet the requirements of section 483.25 is supported by substantial evidence in the record as a whole, including evidence that leaving the resident without undergarments was not pursuant to a physician's order (and indeed was contrary to the physician's later order) and that the resident had an identified issue with scratching herself. ⁽¹¹⁾ Moreover, even if in some circumstances such care might be appropriate, the undisputed evidence that Harmony Court failed to trim the resident's fingernails is substantial evidence supporting the deficiency finding. ⁽¹²⁾

Accordingly, we uphold the ALJ's FFCL A.1.

FFCL A.2. Petitioner failed to comply with the requirement set forth at 42 C.F.R. § 483.25(c).

Section 483.25(c) falls under the general "quality of care" requirement at section 483.25 (quoted above), and provides:

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.

The ALJ found, with respect to the two residents cited in the SOD for the November 1999 survey, that Harmony Court "failed to show either that new pressure sores were unavoidable or that [Harmony Court] provided necessary services to promote healing and to prevent infection of the pressure sores." ALJ Decision at 11.

Resident 16: Resident 16's care plan required repositioning and incontinence care every two hours and pressure-relieving devices for her bed and chair. The resident was documented as having a Stage II pressure sore on her coccyx in October 1999 which had increased to a stage IV pressure sore by the time of the survey. ⁽¹³⁾ The resident was observed sitting in a geri-chair for three hours during which she was not repositioned or checked for incontinence. In addition, the surveyor observed that Resident 16 did not have a pressure relief device on her chair. The surveyor then requested facility staff to provide incontinence care and noted that the resident had a urine-saturated incontinence brief and that there was a large open pressure sore on the resident's coccyx. The ALJ concluded that "by not providing pressure relieving devices on Resident 16's chair, or by leaving her sitting too long in one position, Petitioner clearly was not providing services to promote healing of Resident 16's pressure sore." The ALJ also rejected Harmony Court's assertion that the resident's pressure sore was unavoidable because of her condition, noting that Harmony Court provided evidence to this effect only from an LPN, not an R.N. or a physician. ALJ Decision at 13.

On appeal, Harmony Court argues that the ALJ should have credited the opinion of the LPN that Resident 16's pressure sore was unavoidable since, based on her work experience, the LPN was more qualified to give an opinion on this matter than Surveyor Truett, who observed the resident. Harmony Court also disputes the finding in the SOD that the resident sat in a chair for three hours without her incontinence brief being checked, asserting that it was not possible that Surveyor Truett observed the resident "constantly" for three hours and that Surveyor Truett had not personally checked the resident's incontinence brief to ascertain that it was wet. Request for Review at 12, citing Tr. at 245.

We conclude that the ALJ did not err in not crediting the testimony of the LPN. In general, as an appellate body, the Board does 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. See, e.g., Koester Pavilion, DAB No. 1750 (2000). Harmony Court did not identify any such compelling reason here. Moreover, the LPN's testimony to the effect that Resident 16 was at high risk for pressure sores does not undermine the ALJ's conclusion that Harmony Court did not establish that the resident's new pressure sore was clinically unavoidable. As the Board has previously held, "[a] facility cannot meet its burden of proof on the issue of whether a pressure sore is unavoidable merely by establishing that the resident's clinical condition heightens the risk that pressure sores will develop." Ivy Woods Health Care and Rehabilitation Center, DAB No. 1933, at 9 (2004). Moreover, the term "clinically unavoidable" means 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 SOM, App. PP).

We further conclude that the ALJ's finding that Resident 16 sat in a chair for three hours without her incontinence brief being changed is supported by substantial evidence, cited in the ALJ Decision. ALJ Decision at 12, citing Tr. at 30-32, 34-39; see also CMS Ex. 3, at 10. ⁽¹⁴⁾

Resident 21: Resident 21's care plan called for repositioning every two hours, pressure-relieving devices on the resident's bed and chair, and incontinence care every two hours. The ALJ Decision recites the findings in the SOD that the resident's geri-chair had no pressure-relieving device and that his bed had no pressure-relieving mattress. The ALJ Decision also notes that, according to the SOD, Resident 21 was observed on November 4 sitting in his geri-chair from 10:50 to 11:30 a.m. and from 12:50 to 1:13 p.m., at which time he was transferred to his bed, his brief was changed, and he was left lying in his bed from approximately 1:13 p.m. until 4:10 p.m. without a position change, and further, that the next day, he was observed in his geri-chair from 8:30 to 11:30 a.m. The ALJ found that, "by not providing pressure-relieving devices on his bed or chair or frequent position changes and incontinence care as indicated in his care plan, Petitioner was not ensuring that Resident 21 was receiving necessary care and treatment and services to promote healing, prevent infection, and prevent new sores from developing." ALJ Decision at 13-14. ⁽¹⁵⁾

On appeal, Harmony Court challenges the factual basis for the deficiency finding with respect to this resident, asserting that Surveyor Truett acknowledged that the times stated in the SOD were incorrect and that she was gone for part of the time that Resident 21 was seated in the geri-chair. Request for Review at 11-12, citing Tr. at 41-43. We conclude, however, that there is substantial evidence in the record to support the ALJ's finding that Harmony Court did not provide Resident 21 with frequent position changes and incontinence care as indicated in his care plan. ALJ Decision at 14, citing Tr. at 45 and CMS Ex. 3, at 12. In any event, Harmony Court does not dispute on appeal the ALJ's findings that neither the resident's geri-chair nor his bed had a pressure-relieving device, contrary to his plan of care.

Accordingly, we uphold the ALJ's FFCL A.2.

FFCL A.3. Petitioner failed to comply with the requirement set forth at 42 C.F.R. § 483.25(d)(2).

Section 483.25(d)(2) falls under the general "quality of care" requirement at section 483.25 (quoted above), and provides:

(d) Urinary Incontinence. Based on the resident's comprehensive assessment, the facility must ensure that-

* * * * * *

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

The ALJ found that Harmony Court was not in substantial compliance with this provision based on its care of one of four residents cited in the SOD for the November 1999 survey, Resident 13. ⁽¹⁶⁾ Resident 13's care plan indicated she was to be toileted in advance of need. The ALJ found that Harmony Court did not ensure that Resident 13 received appropriate treatment to restore as much normal bladder function as possible because it failed to offer toileting to her when she was still dry. The ALJ noted the testimony of Surveyor Truett that "if a resident is on a toileting program and toileting is not offered, residents can become less able to control urination, can have skin breakdown, and urinary tract infections." ALJ Decision at 15.

On appeal, Harmony Court argues that because Resident 13 was "very demented" and "very agitated" and had to be restrained in a geri-chair, she was "not likely to benefit" from a toileting program, and further, that toileting her would put her "in a position that would create risk of injury." Request for Review at 13.

Harmony Court does not dispute, however, the ALJ's finding that the care plan for Resident 13 called for toileting the resident in advance of need. Thus, contrary to what Harmony Court argues, the facility's own judgment at the time in question was that a toileting program was appropriate for this resident. Moreover, the introductory language in section 483.25 specifically requires the care and services provided by a facility to be in accordance with the resident's plan of care.

Accordingly, we uphold the ALJ's FFCL A.3.

FFCL A.4. Petitioner failed to comply with the requirement set forth at 42 C.F.R. § 483.25(e)(1).

Section 483.25(e)(1) falls under the general "quality of care" requirement at section 483.25 (quoted above), and provides:

Range of motion. Based on the comprehensive assessment of a resident, the facility must ensure that-
(1) A resident who enters the facility without a limited range of motion does not experience reduction in range of motion unless the resident's clinical condition demonstrates that a reduction in range of motion is unavoidable;. . .

The ALJ found that the two residents cited in the SOD for the November 1999 survey experienced reductions in range of motion that Harmony Court did not prove were unavoidable.

Resident 18: Upon admission to Harmony Court in July 1999, Resident 18 had no range of motion limitations. However, he subsequently experienced a decline in his abilities to ambulate which put him at risk for the development of range of motion limitations. In October 1999, the resident was assessed as having a limited range of motion of both legs and feet with lower extremity contractures, and his physician issued orders for him to use bilateral knee splints (on four hours and then off four hours) to improve his range of motion. Resident 18 was subsequently observed for more than a four-hour period without any bilateral knee splints. The resident's clinical record did not include any plan for the application of the splints or for any range of motion services to prevent a further decline in the resident's range of motion. ALJ Decision at 18.

The ALJ found that Harmony Court had not provided any evidence that Resident 18's decreased range of motion between August and October 1999 was unavoidable. The ALJ further found that since the resident's physician had verified the resident's need for knee splints, "the facility was obligated to apply them or, at least, to document why it had not done so." ALJ Decision at 18-19.

On appeal, Harmony Court asserts that Resident 18 would not have benefitted from the application of knee splints since he was "confined to his bed" and "was not going anywhere." Harmony Court also argues that "the failure to apply knee splints after some unquantified measure of time beyond the four-hour period claimed by Ms. Truett" did not establish that the resident was harmed. Request for Review at 14.

We conclude that the ALJ's findings are supported by substantial evidence in the record as a whole. Harmony Court does not point to any evidence in the record supporting its assertion that Resident 18 would not have benefitted from the knee splints because he was bedridden, or indeed, that the resident was bedridden when the knee splints were ordered. In addition, the physician's order to use knee splints reflects a judgment that they would be beneficial. Furthermore, Surveyor Truett testified that if the knee splints and range of motion services had been provided earlier, they could have prevented further decline in the resident's range of motion. Tr. at 54. With respect to Harmony Court's assertion to the effect that there was no actual harm, it is important to note that the ALJ found actual harm not in the single incident observed by the surveyor in which the facility failed to use knee splints, but in the facility's failure to take steps to prevent further reduction of the resident's range of motion.

Resident 21: Shortly after his admission to Harmony Court in July 1999, Resident 21 was assessed with no range of motion limitations. In September 1999, the facility's occupational therapist indicated the need to initiate a maintenance program for the resident's upper extremity range of motion. Upon his discharge from occupational therapy on October 6, 1999, the resident was documented as having limited range of motion of the right upper extremity and requiring a restorative range of motion program. The documentation indicated that the resident had limited range of motion of the right upper extremity and that he was to be placed on a restorative range of motion program. ⁽¹⁷⁾ No restorative program was initiated and the resident's clinical record was silent for any planned range of motion interventions. The ALJ found that "Petitioner's evidence is insufficient to counter CMS's evidence that Resident 21's range of motion declined after admittance to the facility. Moreover, Petitioner provided no evidence that Resident 21's condition made his range of motion limitations unavoidable." ALJ Decision at 19.

On appeal, Harmony Court argues that the deficiency finding is unwarranted since the resident's range of motion did not decline after his October 6 discharge from occupational therapy. Request for Review at 14.

This argument is unavailing. A deficiency exists regardless of whether Resident 21 experienced a decline in his range of motion after October 6. Section 483.25(e)(1) provides that a resident who enters the facility without a limited range of motion must not experience reduction in range of motion unless the resident's clinical condition demonstrates that such a reduction was unavoidable. It is undisputed that there was a reduction in the resident's range of motion following his admission to the facility and that the reduction was not unavoidable.

Accordingly, we uphold the ALJ's FFCL A.4.

FFCL A.6. Petitioner failed to comply with the requirement set forth at 42 C.F.R. § 483.25(h)(2).

Section 483.25(h)(2) falls under the general "quality of care" requirement at section 483.25 (quoted above), and provides:

Accidents. The facility must ensure that-

* * * * * * *

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

The ALJ found, with respect to the two residents cited in the SOD for the November 1999 survey, that Harmony Court did not provide adequate supervision and assistance devices to prevent accidents.

Resident 21: Resident 21 was assessed as at risk for falls, with care plan interventions that included keeping mats on the floor beside his bed and the use of two full side rails on the bed. On September 18, 1999, Resident 21 had been in bed but was subsequently found on the floor with a large laceration on his forehead requiring stitches. The resident's physician ordered the use of one full side rail instead of two on October 5, 1999. Surveyor Truett testified that Resident 21 had a history of falls from the bed with the use of two side rails and that having two side rails up may be more dangerous if a resident is able to crawl over the side rail because the resident is at greater risk of injury if he/she falls crawling over a side rail than if he/she falls during a normal exit from the bed. On November 4, 1999, the resident was observed in bed with both side rails raised and no mats placed beside the bed. The ALJ found that Harmony Court's failure to install bedside mats and its use of two side rails rather than one constituted a failure to provide the necessary "assistive devices" to prevent accidents and injuries for Resident 21. ALJ Decision at 21-22.

On appeal, Harmony Court asserts that Resident 21 had never fallen over the side rails at the facility, only in the hospital. Request for Review at 15, citing Tr. at 202 (testimony of Harmony Court's former nurse, in response to inquiry whether Resident 21 had fallen prior to the November survey, that the resident "went over the side rails in the hospital"). Regardless of whether the resident actually fell from bed on September 18, or whether any such fall occurred with the side rails up, there is substantial evidence in the record, including the testimony of Surveyor Truett, that the resident's physician ordered the use of only one side rail up on October 5 because he determined that having two side rails up posed a risk of falls. Thus, Harmony Court's assertion does not point to any error in the ALJ's conclusion that Harmony Court violated section 483.25(h)(2) when it kept the resident in bed with two side rails up on November 4 in contravention of the physician's order.

Harmony Court also asserts that it presented evidence that bedside mats were used, contrary to what the ALJ found. Request for Review at 15. Harmony Court may be referring to the testimony of its former nurse that the facility used bedside mats for this resident in the month prior to the survey (Tr. at 202). The nurse did not specifically state that mats were there on the date of the survey, however, and we decline to substitute our judgment on the facts for a reasonable judgment by the ALJ.

Resident 18: Resident 18 had a history of falls from bed and was to use a physical restraint at all times. CMS Ex. 3, at 23. In August 1999, Harmony Court was given orders for the resident to be up in a wheelchair with a lap tray (tray restraint) and for the use of two side rails on his bed. CMS Ex. 7, at 15, 17, 21. On August 24, the facility noted that it had discontinued using two side rails and turned the bed to the wall on one side in order to reduce restraints. CMS Ex. 7, at 21; P. Ex. 5, at 57. On September 13, 1999, the resident was holding onto the sink while being changed for incontinence care, attempted to sit in a chair, and instead fell to the floor. On September 16, 1999, the resident fell between the wall and his bed after pushing against the wall hard enough to move the bed away from the wall. CMS Ex. 7, at 16-17, 19; P. Ex. 5, at 56. A new order for two side rails was later given, and the facility noted that maintenance was to be notified to check the brakes on the bed. CMS Ex. 7, at 17, 19. On October 9, 1999, Resident 18 fell from his wheelchair. There was no tray on the wheelchair at the time and Harmony Court did not provide any information about why this was so in response to the surveyor's request. Harmony Court's nurse testified that the resident removed the tray from the wheelchair himself. However, the ALJ found that "the greater weight of the evidence is that Petitioner failed to provide the supervision or side rails or a tray restraint necessary to prevent Resident 18 from falling." ALJ Decision at 23.

On appeal, Harmony Court describes the resident's September 16 fall as "a first time fall from his bed" and notes that it prevented further falls from bed by reinstating two side rails. Harmony Court also argues that it could "hardly be faulted for the resident's unforeseen conduct in removing his tray from his chair when he had never done this before." Request for Review at 15.

These arguments do not provide a basis for reversing the deficiency finding as to this resident. The Board has previously held that pursuant to section 483.25(h)(2), a facility must provide supervision and assistance devices that reduce known or foreseeable accident risks to the highest practicable degree, consistent with accepted standards of nursing practice. See, e.g., Woodstock Care Center, DAB No. 1726, at 21, 25, 40 (2000), aff'd, Woodstock Care Ctr. v. Thompson, 363 F.3d 583 (6th Cir. 2003); Florence Park Care Center, DAB No. 1931 (2004). The ALJ could reasonably have concluded that such an accident was foreseeable even though Resident 18 had not previously fallen from his bed in the exact way that he did when the side rail next to the wall was down. ⁽¹⁸⁾

Moreover, there is substantial evidence in the record to support the ALJ's conclusion that Harmony Court failed to provide the necessary supervision and assistance devices to reduce the risk of the resident's falling out of his wheelchair. As the ALJ noted, Harmony Court did not provide any explanation for the missing tray at the time of the survey. Moreover, the Post Fall Assessment Update dated October 16, 1999 does not contain any indication that the resident had removed the tray from his wheelchair. P. Ex. 5, at 52-54. Thus, there is no reason to disturb the ALJ's determination not to credit Harmony Court's nurse's testimony that the resident himself had removed the tray from the wheelchair.

Accordingly, we uphold the ALJ's FFCL A.6.

FFCL B.1. Petitioner failed to substantially comply with 42 C.F.R. § 483.15(g).

Section 483.15(g) falls under the general rubric of "Quality of life" in section 483.15 ⁽¹⁹⁾ and provides in pertinent part:

Social Services. (1) The facility must provide medically-related social services to attain or maintain the highest practicable physical, mental, and psychosocial well-being of each resident.

The ALJ found that Harmony Court failed to provide medically-related social services as required by this provision with respect to one of three residents cited in the SOD for the January 2000 survey, Resident 105. The resident had diagnoses of schizophrenia, cirrhosis with hepatic encephalopathy, diabetes, asthma, and a history of alcoholism. In the months following his admission in April 1999, the resident was frequently given weekend passes to leave the facility; however, a September 20, 1999 nurse's note indicates that passes would no longer be given as the resident was non-compliant with his medications and because of his alcohol abuse. P. Ex. 12, at 3, 5; CMS Ex. 26, at 10-15. The resident continued to leave the facility on weekends against medical advice. CMS Ex. 26, at 15-17, 19, 22. An October 26, 1999 physician's progress note indicated that Resident 105 was leaving the facility over the weekend, getting drunk and fighting, and stated that Resident 105 should not be permitted to leave against medical advice and should either be on a secured unit or live in the community and be more responsible for his actions. On November 10, 1999, the resident and Harmony Court's social services designee signed an agreement that required that the resident sign himself out before leaving the facility against medical advice, prohibited him from returning to the facility if he was intoxicated, and provided that the facility would proceed with a discharge if his whereabouts were unknown for 24 hours. The nurse's notes show that the resident's blood alcohol level was drawn when he returned to the facility on November 17, 1999 after a one-night absence, but do not state the results of this test. The surveyors noted that "Social services was silent to these issues, silent to the physician's recommendations, silent to conversations in the past three months with the resident concerning these behaviors, and silent to the safety of the resident when out on pass." CMS Ex. 12, at 10-11. The ALJ noted that Harmony Court's social services designee testified that she put the facility's phone number and address and her name on the resident's identification and that she was trying to find a less restrictive setting for the resident and had had interviews with another facility. ⁽²⁰⁾ The ALJ concluded, however, that-

Resident 105 put himself in harm's way by leaving the facility, and drinking and fighting. Putting an address and phone number on his person were insufficient to protect him. Social services should have been more actively involved in keeping the resident from leaving the facility or in finding him alternative living arrangements, as suggested by his physician. Residents who are unable to care for themselves should not be signed out of the facility without adequate oversight.

ALJ Decision at 27-28.

On appeal, Harmony Court argues that "[t]he measures that the ALJ wishes to impose on Harmony Court under the auspices of the provision of medically-related social services fall well outside the scope of the regulation . . . ." According to Harmony Court, "[t]he actions of the facility are congruent with the resident's rights and the direction of the ombudsman and the resident's attorney that Res. 105 had the right to come and go as he chose." Request for Review at 16.

The ALJ specifically found that Harmony Court was not in substantial compliance with section 483.15(g) because it failed to provide medically-related social services as required by the regulation. ⁽²¹⁾ ALJ Decision at 25. There is substantial evidence in the record to support this finding. Other than the November 10 agreement itself, there is no documentation of any social services contact with Resident 105 in the three months between an August 26, 1999 entry in the Social Progress Notes and an entry dated November 29, 1999 (CMS Exhibit 26, at 47). ⁽²²⁾ Harmony Court's interdisciplinary plan of care for the resident dated April 28, 1999 (CMS Exhibits 26, at 34) provided for a one-to-one social services visit one to four times monthly. Thus, the social services contacts in August and November were clearly inadequate to address the resident's failure to take his medications and his drinking during his frequent absences from the facility. Even if the social services designee's attempts to find another placement for the resident were made during this period, they did not fulfill Harmony Court's obligation to provide medically-related social services to "attain or maintain" the resident's "highest practicable physical, mental, and psychosocial well-being" while he was still residing at the facility.

Accordingly, we uphold the ALJ's FFCL B.1.

FFCL B.3. Petitioner failed to comply with the requirement set forth at 42 C.F.R. § 483.15(h)(2).

Section 483.15(h)(2) provides:

Environment. The facility must provide-

* * * * * *

(2) Housekeeping and maintenance services necessary to maintain a sanitary, orderly, and comfortable interior;. . .

The surveyors determined that there was a deficiency under this section based on over 60 separate observations regarding maintenance or housekeeping services. The ALJ noted the testimony of Harmony Court's administrator that the facility had a new owner who was renovating the facility. The ALJ acknowledged that "facilities in the midst of renovation should be given some leeway for painting or carpeting in progress," but continued:

The picture of Petitioner's facility painted by the surveyors and unrebutted by Petitioner, however, suggests a facility that has failed to maintain its building and equipment for a long period of time. Occupied facilities should not have deteriorated to the point of doors and windows not closing, crumbling walls, sections of tile missing in rooms, and damaged furniture. These are maintenance problems that should be addressed on an ongoing basis.

The ALJ further stated that "housekeeping must be done in a facility regardless of ongoing renovations" and noted that, although Harmony Court submitted its job description for housekeeping and its room cleaning procedures, "[n]o one for Petitioner rebutted . . . the alleged housekeeping omissions."

ALJ Decision at 30-32.

On appeal, Harmony Court claims that the maintenance and housekeeping problems were attributable to the facility's prior owner. Harmony Court also notes that the prior survey had not found it out of compliance with this participation requirement, suggesting that this calls into question whether the problems cited in the SOD in fact existed. Harmony Court asserts that--

the ALJ should have required CMS to present photographic evidence and perhaps even some test results to directly prove the existence of problems claimed by CMS and obtain an idea as to how (if at all) they affected the operation of the facility or presented risk to its residents. As it is, there was no testimony presented that any of the rooms were occupied at the time the observations were made or that any harm befell the residents by way of illness or the like.

Request for Review at 17-18.

To the extent that Harmony Court intends to argue that it did not bear any responsibility for the prior owner's failure to properly maintain the facility, however, that argument has no merit. The Board has previously stated that the applicable regulation "plainly holds new owners to compliance with all participation requirements from the time of the assignment of the [provider] agreement and therefore supports the conclusion that all providers are subject to the normal enforcement authorities, regardless of how long they have owned or operated their facilities." CarePlex of Silver Spring, DAB No. 1627 at 10 (1997), citing 42 C.F.R. § 489.18(d). ⁽²³⁾ In any event, as the ALJ noted, the housekeeping problems were clearly not attributable to the prior owner since housekeeping must be done on an ongoing basis.

Moreover, contrary to what Harmony Court suggests, CMS met its initial burden of establishing the facts underlying the finding of noncompliance by offering the SOD into evidence. See Guardian Health Care Center, DAB No. 1943, at 14 (2004)("The SOD is a contemporaneous record of the survey agency's observations and investigative findings, and . . . CMS may make a prima facie showing of noncompliance based on that document if the factual findings and allegations it contains are specific, undisputed, and not inherently unreliable"). The burden then shifted to Harmony Court to produce rebuttal evidence. The ALJ stated that Harmony Court "did not deny that the facility had the interior problems noted by the surveyors." ALJ Decision at 31. Furthermore, that the prior survey did not find noncompliance under section 483.15(h)(2) does not call the January survey findings into question. As the ALJ noted, "the January survey was an annual recertification survey [as opposed to the prior survey, which was a complaint survey] and it is likely the surveyors were concentrating on different issues . . . ." ALJ Decision at 30. ⁽²⁴⁾ In any event, it is questionable whether a facility can ever rely on a surveyor's failure to cite a deficiency as a basis for thinking it is in substantial compliance with a participation requirement. Finally, as noted earlier, a deficiency can exist in the absence of actual harm if there is a potential for more than minimal harm. We reject any suggestion by Harmony Court that there was no potential for more than minimal harm because the rooms identified in the SOD were not occupied when the observations were made. Harmony Court alleges only that the rooms were unoccupied at the time of the survey, not that they were never occupied, and does not point to any evidence that the rooms were unoccupied at any point.

Accordingly, we uphold the ALJ's FFCL B.3.

FFCL B.4. Petitioner failed to comply with the requirements of 42 C.F.R. § 483.25(c).

Section 483.25(c), relating to pressure sores, is quoted in the discussion of FFCL A.2 above. The ALJ found, with respect to the three residents cited in the SOD for the January 2000 survey, that Harmony Court "did not do all it could have done for these three residents to prevent new avoidable pressure sores from developing or to promote healing and prevent infection." ALJ Decision at 35.

Resident 13: Resident 13 was readmitted to the facility on December 27, 1999 after a hip fracture but was not assessed as at high risk for pressure sores. CMS Ex. 12, at 33. The resident subsequently developed a Stage II pressure sore on her mid-back and a large open bruise on her left buttock, both of which were identified by the facility on January 4, 2000. The bruise was identified by the surveyor a week later as a Stage IV pressure sore. On January 5, the facility obtained a physician's order that the resident was to be up in her chair only one hour for meals. However, during the survey, Resident 13 was observed in her chair for longer periods for two meals. The surveyor also observed a nurse aide providing incontinence care to Resident 13 wiping stool toward the pressure sore dressing, which lifted off the edges of the dressing and visibly soiled the gauze.

The ALJ noted that, while Harmony Court's nurse testified that the bruise on Resident 13's buttock was not a pressure sore because of its shape, ⁽²⁵⁾ the nurse had nevertheless described the bruise as a "Stage II area" in the resident's skin report on January 4. The ALJ concluded that the surveyor "credibly described" the bruise as a pressure sore and that "the resident should not have been seated for as long as she was." The ALJ further found that "the resident's incontinence care was provided in such a way that Petitioner clearly was not doing all it could do to promote healing of Resident 13's pressure sores." ALJ Decision at 32-33.

On appeal, Harmony Court argues that the ALJ erred in finding that the resident had a pressure sore on her buttock. Harmony Court takes the position that the nurse who testified for it was a more credible witness since she is "much more familiar with this resident's condition and the current state of nursing standards for the identification of pressure sores than someone like Surveyor Truett, who has not worked clinically as a nurse in a decade and was charged with making multiple observations on all the supposed citations." Harmony Court also asserts that even if this was a pressure sore, it was unavoidable because the resident was at high risk for development of pressure sores due to immobility as a result of her hip fracture. According to Harmony Court, moreover, "the care provided to this resident for her skin was consistent with [the nurse's] professional education, skill and training." Request for Review at 18-19.

We find no compelling reason for disturbing the ALJ's decision to credit the testimony of the surveyor, rather than that of Harmony Court's nurse, concerning whether the resident had a pressure sore. Indeed, as the ALJ noted, Harmony Court's nurse's testimony was contradicted by her own entry in the resident's skin report. ⁽²⁶⁾

Harmony Court's other arguments are also unavailing. As discussed earlier, the fact that a resident's clinical condition may heighten the resident's risk of developing pressure sores does not establish that a pressure sore is unavoidable. Moreover, Harmony Court's general allegation that the nurse provided appropriate care is not sufficient to rebut the surveyor's specific testimony that the nurse aide providing incontinence care allowed the dressing on one of the resident's pressure sores to become contaminated with bacteria from her stool (and that if this type of bacteria gets in a wound, it will cause an infection). See Tr. at 114-115. Nor does it rebut the evidence that the resident was up in her chair for periods longer than an hour, contrary to her physician's order.

Resident 39: Resident 39 had a Stage IV pressure sore on her coccyx. She had physician orders to be out of bed for tube feeding only, which normally takes 20-30 minutes each time. According to the SOD, Resident 39 was observed sitting in a geri-chair for an hour, starting two hours before her scheduled tube feeding. The SOD also states that the surveyor observed a nurse aide who was providing incontinence care for the resident wipe a stool-stained cloth over the dressing on the resident's pressure sore, lifting the sealed dressing barrier and visibly soiling the gauze.

The ALJ noted the testimony of Harmony Court's nurse that the resident was in her chair early because her feeding tube had opened and soiled the linen on her bed. The ALJ stated, however, that this "does not address why it took at least an hour for the staff to clean the linen on Resident 39's bed" and that "staff should have been aware that this resident was seated an inappropriately long time . . . ." In addition, the ALJ noted the nurse's testimony that only the top of the dressing, not the wound itself, was contaminated with stool, and that the nurse changed the dressing after staff who provided the incontinence care notified her of the contamination. The ALJ stated, however, that this testimony "is not directly responsive" since "[a] cloth with stool on it should not come into contact with a dressing over a Stage IV pressure sore." The ALJ continued: "If a facility's staff does soil such a dressing, the facility is not doing all it can to promote healing of a pressure sore." ALJ Decision at 33-34.

On appeal, Harmony Court argues that it was not reasonable for the ALJ "[t]o create a bright line rule . .. . that it is a violation of the regulatory requirement . . . every time stool happens to come into contact with a dressing . . . ." According to Harmony Court, "the dressing exists precisely to act as a barrier and prevent contamination because stool cannot penetrate the dressing." Harmony Court also asserts that "[s]ince nurse aides are usually the staff who perform incontinence care . . . and since nurse aides cannot change dressings," this rule would penalize "even the slightest mis-step in the delivery of care . . . when the person creating the situation is powerless to remedy it." Request for Review at 19.

We need not address Harmony Court's argument regarding the contamination of the pressure sore. Harmony Court does not dispute that Resident 39 had an advanced-stage pressure sore on her coccyx, that she was left sitting in a chair for a period of time significantly exceeding the time contemplated by the physician's order, and that Harmony Court therefore failed to promote the healing of the pressure sore. This is a sufficient basis for upholding the deficiency finding as to this resident.

Resident 47: Resident 47 had a newly acquired pressure sore on his coccyx at the time of the survey. The resident was repeatedly observed lying on his back when he should have been lying on his left or right side, according to the turn schedule in his plan of care. There was no turn pillow in the bed to keep the resident from rolling onto his back after he was turned on one side. The day after the survey, Harmony Court bought a big body pillow to keep the resident in position.

The ALJ stated that Harmony Court was on notice from the turn schedule that the resident should be prevented from being in the same position for excessive periods of time in order to prevent pressure sores and to promote healing of the sores the resident had acquired. The ALJ also stated that "by not employing some type of device, such as a rolled blanket or body pillow" to keep the resident from rolling over onto the pressure sore, Harmony Court "was not doing all it could do to prevent sores from developing or to promote the healing of Resident 47's pressure sores." ALJ Decision at 35.

On appeal, Harmony Court argues that the deficiency finding is incorrect "because the resident caused his own compromised skin areas from his constant squirming and movements." Harmony Court also asserts that it had no notice that it should have done more than it did prior to the time the pressure sore developed. Request for Review at 20.

The same arguments were previously raised before the ALJ and the ALJ's determination that they are unavailing is supported by substantial evidence in the record as a whole. As noted above, a facility is required to take necessary action to prevent the development of a pressure sore unless the resident's clinical condition renders the development of a pressure sore unavoidable. The resident's squirming clearly did not render the pressure sore unavoidable since Harmony Court's nurse testified that the big body pillow seemed to contain the squirming. ALJ Decision at 35, citing Tr. at 253, 261. In addition, the ALJ found that the existence of a turn schedule showed that Harmony Court "was on notice that [the resident] should be turned regularly - and prevented from being in the same position for excessive periods of time due to his compromised skin condition - in order to prevent pressure sores and promote healing of the sores he had acquired." Id. at 35. Moreover, Harmony Court knew prior to its purchase of the big body pillow that its interventions were not effective since its nurse testified that the facility attempted to prop the resident up by placing a small pillow behind the resident's back, but that the resident "always" threw the pillow out of the bed. Tr. at 253, 262.

Accordingly, we uphold the ALJ's FFCL B.4.

FFCL B.5. Petitioner failed to comply with the requirement set forth at 42 C.F.R. § 483.25(d)(2).

Section 483.25(d)(2), relating to bladder function, is quoted in the discussion of FFCL A.3 above. The ALJ found that Harmony Court was not in substantial compliance with this provision based on its care of one of two residents cited in the SOD for the January 2000 survey, Resident 39. This resident was observed receiving incontinence care after having been incontinent of stool. The nurse aide providing the care failed to turn the cloth after wiping the stool from Resident 39's perirectal area before wiping the opening to the urinary tract.

The ALJ found that the care provided Resident 39 put the resident at risk for a urinary tract infection. The ALJ stated that, while Resident 39 did not get a urinary tract infection, "[t]he issue is . . . whether she was receiving appropriate treatment and services to prevent such infections." The ALJ also noted testimony by Harmony Court's clinical advisor that the care in question was not typical of the incontinence care provided at the facility, that the facility does extensive training of nurse aides, and that, as part of quality assurance monitoring, the facility observes aides providing perineal care using a checklist of steps necessary to properly provide care. However, the ALJ stated that Harmony Court failed to specify the period of time during which the training occurred and that the record did not contain any indication that the "checking procedures" were in place during the month of the survey. ALJ Decision at 36.

On appeal, Harmony Court reiterates that nurse aides received extensive training and that the incontinence care provided to Resident 39 was "not typical" of the care provided. Harmony Court also emphasizes that Resident 39 never developed a urinary tract infection and that it had very low infection rates in 1999 through 2000. Request for Review at 20.

As discussed previously, however, a deficiency can exist in the absence of actual harm if there is a potential for more than minimal harm. The ALJ found in effect that Harmony Court had not established that the incident in question posed a potential for only minimal harm because Harmony Court failed to specify when the training and the monitoring took place. Harmony Court's argument on appeal does not address this evidentiary shortcoming. Moreover, even if the improper care provided to Resident 39 by the nurse aide was not typical of the care generally provided by Harmony Court, this goes to the scope of the deficiency (which CMS found was isolated) and does not establish substantial compliance. Having one nurse aide provide improper care could still have the potential for more than minimal harm; furthermore, Harmony Court was required to ensure that "each resident receives" care meeting the standard.

Accordingly, we uphold the ALJ's FFCL B.5.

FFCL B.6. Petitioner failed to comply with the requirement set forth at 42 C.F.R. § 483.25(h)(1).

Section 483.25(h)(1) falls under the general "quality of care" requirement at section 483.25 (quoted above), and provides:

Accidents. The facility must ensure that-
(1) The resident environment remains as free of accident hazards as is possible;. . .

The ALJ found that Harmony Court "contained several rooms where dangerous substances were too accessible to Petitioner's residents and presented the potential for more than minimal harm, especially to Petitioner's residents on the behavioral unit." The ALJ concluded that Harmony Court failed to rebut CMS's prima facie case that it was not in compliance with the regulation since Harmony Court "did not address any of the observations testified to by the surveyors at the hearing," except to concede that the janitor's closet was unlocked, "or the potential for harm caused by the hazardous materials." ALJ Decision at 36-37.

On appeal, Harmony Court asserts that the ALJ neglected to mention that the janitor's closet "is in a high staff traffic area," citing the testimony of its administrator (at Tr. at 187) that "it's right in a hallway and people going by . . . normally . . . would just lock it . . . ." Request for Review at 21. The ALJ cited to the same testimony and viewed it as a concession that the janitor's closet was left unlocked. We see no reason to disturb her reasonable judgment. Moreover, Harmony Court did not dispute the numerous other observations cited by the ALJ as a basis for her finding of noncompliance.

Harmony Court also asserts that the ALJ "stretch[ed] the concept of foreseeability to its remotest penumbras," noting that no accidents in fact occurred and arguing that there was no potential for more than minimal harm since there is no basis for any assumption that residents of the behavioral unit might have ingested the hazardous substances. Request for Review at 21. However, the ALJ could reasonably infer from Surveyor Thompson's testimony that residents on the behavioral unit "did not have good decision-making ability generally" (Tr. at 123) that there was a danger of the residents ingesting the hazardous substances.

Accordingly, we uphold the ALJ's FFCL B.6.

FFCL B.7. Petitioner failed to comply with the requirements set forth at 42 C.F.R. § 483.25(h)(2).

Section 483.25(h)(2) is quoted in the discussion of FFCL A.6 above. The ALJ found that Harmony Court was not in substantial compliance with this provision based on its care of one of the four residents cited in the SOD for the January 2000 survey, Resident 77.

Resident 77 was a cognitively impaired resident who was assessed as a high elopement risk with attempts to elope from the facility as recently as December 1999. The resident had physician's orders for every 15 minute checks for risks of elopement and self-harm as well as for an every-shift check of the placement of his audible ankle bracelet (which would set off an alarm if he tried to leave the unit or building). In addition, the manufacturer's instructions for the ankle bracelet said that its placement was to be checked at every shift change and that a documented test of the transmitter's performance should be done daily.

The ALJ found that Harmony Court had no documentation to assure that the ankle bracelet's placement was checked every shift, no documentation of the required every quarter hour check of the resident, and no documentation of checks of the transmitter's performance. The ALJ noted testimony by Harmony Court's nurse "that Resident 77's ankle bracelet was constantly being checked because he would walk up to the doors and the bracelet would go off"; however, the ALJ stated that she did not find "Petitioner's rather haphazard check of Resident 77's ankle bracelet to be the type of attention to the manufacturer's instructions or the response to the physician's order for an every 15 minute check that would suffice as 'doing everything possible' to prevent accidents." The ALJ also noted the nurse's testimony that Resident 77 never actually eloped from the facility, but stated that this fact "does not confirm that Petitioner was doing everything possible within its ken to prevent elopement." ALJ Decision at 38.

On appeal, Harmony Court maintains that the physician's order for an every-shift check of the ankle bracelet was carried out "because the resident would essentially 'self-test' the alarm, allowing staff to easily tell whether it was working or not because it would go off." Request for Review at 21. The ALJ fully considered this argument, and we see no basis for revisiting her determination that the self-testing did not meet the regulatory requirement. ⁽²⁷⁾ While Harmony Court could arguably be excused from checking the placement of the ankle bracelet during a shift where the resident had already tripped the alarm, Harmony Court did not show that it had in place any system for checking the placement of the ankle bracelet each shift, as required by the physician's orders.

Harmony Court also suggests that the ALJ Decision is inconsistent with the "'outcome oriented' regulatory standard" since the resident never in fact eloped, citing Woodstock Care Center, DAB No. 1726, at 25-30. Request for Review at 22. The fact that the resident never eloped is immaterial, however, since, as discussed earlier, a facility may be found out of substantial compliance as long as the deficiency involves a potential for more than minimal harm.

Harmony Court further argues that it was error for the ALJ to "equate[] the manufacturer's instructions for an ankle bracelet alarm with the standard the facility was to employ to prevent Res. 77 from eloping." Request for Review at 21. We need not rely on Harmony Court's failure to comply with the manufacturer's instructions in order to sustain the deficiency finding, however, since the resident's physician had specifically determined that the facility should not only check the placement of the resident's ankle bracelet every shift but also check the resident every quarter hour. Harmony Court did not dispute the ALJ's finding that the resident was not checked every quarter hour.

Accordingly, we sustain the ALJ's FFCL B.7.

FFCL C.1. CMS proved that Harmony Court remained noncompliant with the requirements at 42 C.F.R. § 483.25(h)(2).

Section 483.25(h)(2) is quoted in the discussion of FFCL A.6. above. The ALJ found that Harmony Court was not in substantial compliance with this provision based on its care of the one resident cited in the SOD for the March 2000 survey, Resident 12. Resident 12's comprehensive assessment dated March 2, 2000, covering her status in the last seven days, stated that she was dependent on two staff members for bed mobility, toileting, transfers and bathing. ⁽²⁸⁾ Nurse's notes indicated that on February 25, 2000, the resident slid from a geri-chair and fell to the floor, sustaining injuries to her forehead and nose. At the time, the resident was in the bathroom with only one nurse aide. The aide told the surveyor that when she put a gait belt around Resident 12 and attempted to transfer her to a standing position, the resident slid forward and down in her geri-chair.

The ALJ noted that the report of an occupational therapy screening done two weeks after this incident stated that at times Resident 12 is very fatigued and requires maximum assist for all transfers, but that at other times of increased alertness, she is appropriate for a one-person transfer. The ALJ found that, contrary to what Harmony Court argued, this report did not show that the resident did not need a two-person assist during the incident in question since Harmony Court submitted no evidence about what "state" Resident 12 was in at the time of her fall, the occupational therapy evaluation indicated that at times the resident needed a maximum assist, and it was undisputed that Harmony Court's director of nursing told the surveyor that Resident 12 needed a two-person assist for transfers and toileting. The ALJ also noted the testimony of Harmony Court's nurse that Resident 12 was not being transferred but rather slid off the end of her chair. The ALJ stated that Resident 12's sliding off her chair while a nurse aide was trying to get her into a standing position "is the essence of a transfer" and that another staff member could have intervened and prevented the resident from sliding off the chair. ALJ Decision at 39-41.

On appeal, Harmony Court again disputes whether the incident in question involved a transfer. In addition, Harmony Court argues that the ALJ improperly relied on the occupational therapy report because it was prepared almost two weeks after the incident in question, and that, in any event, the ALJ erred in imposing the burden on it to show what state Resident 12 was in at the time of her fall. Harmony Court also asserts that it could be implied from the fact that only one staff member was with the resident that the staff member had assessed the resident's state of mind and thought she was safe with a one person assist. Request for Review at 22-23.

Harmony Court's arguments are unavailing. Harmony Court did not point to any error in the ALJ's conclusion that the nurse aide's attempt to transfer the resident from her geri-chair to a standing position was "the essence of a transfer." ⁽²⁹⁾ Furthermore, Harmony Court cannot reasonably object to the ALJ's considering whether a one-person assist could be justified on the basis of the occupational therapy report when Harmony Court's own assessment clearly indicated that, at the time of the incident, the resident needed a two-person assist for transfers, and this assessment was confirmed by the director of nursing's statement to the surveyors. In addition, as discussed earlier, the ultimate burden of showing compliance rests with the facility. Thus, the ALJ correctly concluded that a one-person assist was not justified based on that report on the ground that Harmony Court "submitted no evidence about what state Resident 12 was in at the time of her fall." ALJ Decision at 40. The mere fact that the aide attempted a one-person assist cannot logically be viewed as evidence that the aide assessed the resident as being so alert that a one-person assist was appropriate.

Accordingly, we sustain the ALJ's FFCL C.1.

FFCL IV. The remedies imposed by CMS on Petitioner for its noncompliance found during the November survey, and the January and March surveys, were reasonable.

In addition to challenging CMS's finding of noncompliance, a facility may also contend on appeal that the amount of a CMP imposed is unreasonable. A CMP in the range of $50-$3,000 per day may be imposed for one or more deficiencies that do not constitute "immediate jeopardy" but that either cause actual harm or create the potential for more than minimal harm. 42 C.F.R. § 488.438(a). Within the applicable range, the regulations provide a number of factors to be considered by CMS in determining an appropriate CMP amount. These factors are the facility's history of noncompliance, its financial condition, its culpability for the cited deficiencies, the scope and severity of those deficiencies, and the relationship between or among the deficiencies. 42 C.F.R. § 488.438(f)(3), incorporating by reference 42 C.F.R. § 488.404. "Culpability" is defined as including "neglect, indifference, or disregard for resident care, comfort or safety." 42 C.F.R. § 488.438(f)(4).

Two CMPs are at issue here: a CMP of $1,150 per day for the period November 5 through December 9, 1999, and a CMP of $550 per day for the period January 19 through March 25, 2000.

The ALJ noted at the outset of her discussion that, although Harmony Court raised the issue of the reasonableness of the CMP amounts, the facility "provided no evidence or argument regarding its compliance history, financial condition, or degree of culpability . . .." The ALJ then stated that several of the deficiencies that CMS substantiated during the survey that was the basis for the $1,150 per day CMP ⁽³⁰⁾ resulted in actual harm to the residents and that some of these deficiencies show a disregard for the residents' comfort. Based on these factors, the ALJ found that the $1,150 per day CMP, which she noted "is mid-way between the allowed CMPs for the scope and severity of the deficiencies," was reasonable. The ALJ further stated that the deficiencies found in the January survey included a "repeat deficiency" under section 483.25(c) (pressure sores) that resulted in actual harm and that the March survey also found a deficiency that resulted in actual harm. Based on these factors, the ALJ determined that the $550 per day CMP was reasonable. ALJ Decision at 44-45.

On appeal, Harmony Court argues that the ALJ should not have considered evidence of repeated deficiencies in CMS's Exhibit 40, an Online Survey and Certification (OSCAR) report, which the ALJ admitted over Harmony Court's objection. Harmony Court argues that, without evidence of a repeated deficiency, a CMP above the $50 per day minimum was not warranted. Request for Review at 24. (This argument pertains only to the $550 per day CMP, which the ALJ found was reasonable based on factors including a repeat deficiency.)

We are not persuaded that the ALJ erred in admitting the OSCAR report. Harmony Court objected to the admission of this report, of which it received a copy only four days before the hearing, on the ground that the report was unauthenticated and that Harmony Court had not had an opportunity to determine if the report accurately reflected the results of the prior surveys. Tr. at 8. However, Harmony Court has now had such an opportunity and does not contend that the OSCAR report incorrectly shows that there were repeated deficiencies. Since Harmony Court has not established that it was prejudiced by its lack of timely notice of the exhibit, we conclude that the ALJ properly considered the existence of a repeated deficiency in determining the reasonableness of the CMP amount. (Contrary to what the ALJ Decision indicates, the OSCAR report does not show that the pressure sore deficiency found in the January 2000 survey was a repeated deficiency. However, the OSCAR report shows that several other deficiencies identified in the January 2000 survey (and upheld by the ALJ) were identified in the October 2, 1998 survey and subsequently corrected, meeting the definition of repeated deficiencies. ⁽³¹⁾ CMS Ex. 40, at 2.)

Harmony Court also argues that the ALJ must consider all of the factors in section 488.438(f) in a de novo review of the CMP, and that the ALJ thus erred in not considering the facility's financial condition. Request for Review at 25. This argument reflects a misunderstanding of what it means for the ALJ to conduct a de novo review of the reasonableness of the CMP amount. In Coquina Center, DAB No. 1860 (2002), we stated that--

there is a presumption that CMS has considered the regulatory factors [in section 488.438(f)] in setting the amount of the CMP and that those factors support the CMP amount imposed by CMS. Unless a facility contends that a particular regulatory factor does not support that CMP amount, the ALJ must sustain it. . . . If a facility does make such a contention, however, CMS then has a responsibility to produce evidence as to that factor. The ALJ must then "make an independent determination of whether the amount set by [CMS] is reasonable based on the evidence as fully developed in the hearing." Emerald Oaks at 13, quoting CarePlex at 17-18.

Coquina Center at 32. Harmony Court does not dispute the ALJ's statement (at ALJ Decision at 45) that it "has not contended that its financial condition will be affected substantially by the payment of the assessed CMPs or that it cannot pay the CMPs." Thus, CMS was under no obligation to introduce any evidence regarding Harmony Court's financial condition, and the ALJ did not err in not considering this factor in assessing the reasonableness of the CMP amounts.

Harmony Court also asserts that the ALJ "took into consideration only her subjective and unarticulated view of the 'culpability' for violations that was no different in analysis than the supposed findings she made sustaining the citations in the first place." In support of this assertion, Harmony Court cites Lebanon Health Center, DAB No. 1918 (2004) for the proposition that "CMP evidence to show culpability should be distinguishable from the alleged facts relied on to establish a deficiency." Request for Review at 26 (italics in original). (This argument pertains only to the $1,150 per day CMP, which the ALJ found was reasonable based on factors including the facility's culpability.) Nothing in Lebanon stands for the proposition for which Harmony Court cites it, however. ⁽³²⁾ Moreover, we see no reason why evidence that supports a finding of noncompliance cannot also be considered in determining whether culpability exists. Furthermore, the ALJ's finding that "the development of pressure sores and lack of appropriate incontinence care shows a disregard for the residents' comfort" (ALJ Decision at 45) is based on a common-sense inference, and is not purely subjective, as Harmony Court claims.

Accordingly, we sustain the ALJ's FFCL IV.

Conclusion

For the reasons stated above, we affirm all of the ALJ's numbered findings of fact and conclusions of law. Accordingly, we sustain the CMPs imposed in this case.

Daniel Aibel

Judith A. Ballard

Donald F. Garrett
Presiding Board Member

1. All of the deficiencies cited in the November survey were assessed as Level G deficiencies. The deficiencies cited in the January survey that are at issue here were assessed as follows: Tag 250 (section 483.15(g)) - Level E; Tag 253 (section 483.15(h)(2)) - Level F; Tag 314 (section 483.25(c)) - Level G; Tag 316 (section 483.25(d)(2)) - Level D; Tag 323 (section 483.25(h)(1)) - Level E; and Tag 324 (section 483.25(h)(2)) - Level E. The deficiency cited in the March survey was assessed as Level G. As indicated below, CMS adopted the State survey agency findings.

2. The ALJ stated that CMS "waived" eight deficiencies cited by the surveyors and presented no evidence or argument with respect to another deficiency. ALJ Decision at 5-6. There were several additional deficiencies found in the surveys but not addressed by the ALJ.

3. We note that there are some circumstances in which the ALJ's failure to address all of the deficiency findings could affect the remedy imposed by CMS and be prejudicial to the facility, such as where CMS relied on the additional deficiency findings in setting the amount of a CMP above the minimum amount required by regulation, or in determining that the facility had not achieved substantial compliance before a certain date. Those circumstances are not present here, nor does Harmony Court argue that the ALJ should have considered additional deficiency findings.

4. The background information provided for each FFCL is drawn from the undisputed facts in the ALJ Decision and the record before her. It is not intended as a substitute for the ALJ's findings.

5. Harmony Court raises this issue in its exceptions to FFCLs B.3, B.5 (Resident 39), and B.6 (both residents). In conjunction with this, Harmony Court also appears to dispute whether there was a potential for more than minimal harm. We address the latter argument further in the context of the individual FFCLs.

6. Harmony Court raises this issue in its exceptions to FFCLs A.2 (both residents), A.3 (Resident 13), A.4 (Resident 21), and A.6 (Resident 21). In view of our discussion here, we do not address this issue further in our discussion of the individual FFCLs.

7. Many of the numbered FFCLs refer only to a failure to comply with the participation requirement at issue. However, it is clear that the ALJ found that Harmony Court failed to substantially comply with each requirement since the ALJ Decision refers to the lack of substantial compliance in the text that follows the FFCL or there are other indicia in the text that the ALJ found a lack of substantial compliance.

8. This resident was incorrectly identified in the SOD as Resident 19. ALJ Decision at 7, n.4.

9. A pelvic restraint is a cloth that goes between the legs and then is tied around the back. Tr. at 20.

10. A pommel cushion is a saddle-like cushion with a raised front that is used to prevent individuals from sliding forward in chairs. Tr. at 16. Witnesses for both parties testified that the front of the cushion in Resident 13's chair was "mashed" or "smashed" down, although Harmony Court's witness disputed that it was "worn." Id. at 17, 215.

11. The ALJ reasonably accorded little weight to the nurse's testimony that the care was appropriate since that testimony appears to be inconsistent with medical records (at Petitioner's Exhibit 2, at 3) stating that the scratching was due to "dermatitis." The nurse provided a different reason for the scratching, stating that if the resident "was incontinent on the brief, the cotton would soak up the moisture which would create heat . . . and give her the sensation to itch and scratch herself." Tr. at 234. (The nurse also testified, without any support in the record, that she "believe[d]" that the resident's care plan provided that the resident was not supposed to have a brief on while she was in bed. Id.)

12. Harmony Court's failure to trim the resident's fingernails could also have been cited under section 483.25(a)(3), which states that "[a] resident who is unable to carry out activities of daily living receives the necessary services to maintain good nutrition, grooming, and personal and oral hygiene."

13. There are four stages of pressure sores, with Stage I being the least serious and Stage IV being the most serious. SOM App. PP, at 147 (Rev. 4 2004).

14. Even if it was clinically unavoidable that the resident would develop pressure sores, the findings that Harmony Court failed to follow the resident's plan of care for repositioning her and for providing a pressure-relieving device in her chair support the ALJ's conclusion that the facility was not providing the services it had determined were necessary to promote healing.

15. The ALJ did not find it necessary to determine whether a new pressure sore had in fact developed in order to conclude that Harmony Court failed to substantially comply with section 483.25(c). ALJ Decision at 14.

16. The ALJ found that CMS did not make a prima facie case as to Residents 18 and 19. ALJ Decision at 16-17. The ALJ did not mention the fourth resident cited in the SOD, Resident 22. This omission does not affect the ALJ's conclusion that Harmony Court failed to substantially comply with section 483.25(d)(2), since the ALJ stated that, while the noncompliance with respect to Resident 13 was isolated, it "did present the potential for more than minimal harm to Resident 13." Id. at 17.

17. Harmony Court's former MDS restorative nurse testified that "[o]ccupational therapy has to have the resident continuing making progress" and that "[o]nce the resident stops making progress," a restorative program is "used to maintain their abilities." Tr. at 233.

18. It is unclear from the record whether the change from two side rails to one was pursuant to a physician's order. Even if Harmony Court made this change pursuant to a physician's order, however, the facility still bore the responsibility for not checking the brakes on the resident's bed.

19. The introductory language in section 483.15 states: "A facility must care for its residents in a manner and in an environment that promotes maintenance or enhancement of each resident's quality of life."

20. The individual who identified herself at the hearing as the facility's social services designee (SSD) was not the same person who signed an August 26, 1999 entry in the Social Progress Notes (at P. Ex. 12, at 5) as the facility's SSD and the November 10, 1999 agreement referred to above.

21. Notwithstanding the language in the ALJ Decision indicating that it was unwise for Harmony Court to permit Resident 105 to leave the facility, the ALJ did not find that Harmony Court violated section 483.15(g) on that basis.

22. The ALJ Decision states that Resident 105 was counseled about the risks of consuming alcohol when out of the facility. ALJ Decision at 27, citing CMS Ex. 26, at 5-6. This is reflected only in entries in the Social Progress Notes dated June 1 and 3, 1999, however.

23. Section 489.18(c) provides that when there is a change of ownership, "the existing provider agreement will automatically be assigned to the new owner." Section 489.18(d) provides that "[a]n assigned agreement is subject to all applicable statutes and regulations,. . ." (Section 3210 of the SOM indicates that the new owner has the option of applying for a new provider agreement. However, Harmony Court does not allege that it did so here.)

24. The prior survey occurred in November rather than December as Harmony Court and the ALJ indicated in discussing this deficiency citation.

25. The nurse based her opinion on her observation that the pressure sore was crescent-shaped and purple in color, and as well as on her personal knowledge that the resident "would bump up against things." Tr. at 250. However, on cross-examination she stated that she did not know if a pressure sore could present in a crescent shape and admitted that a pressure sore can present as purplish in color. Id. at 260-261.

26. Thus, this is not a case in which a caretaker's familiarity with the resident is a reason to give more weight to the caretaker's testimony.

27. The ALJ's statement that the applicable standard is whether the facility was doing "everything possible" to prevent accidents does not track the wording of the regulation. The regulation requires the facility to take reasonable steps to ensure that a resident receives supervision and assistance devices designed to meet his or her assessed needs and to mitigate foreseeable risks of harm from accidents. See Woodstock Care Center, DAB No. 1726. However, we find that the ALJ in fact applied the correct standard here.

28. The ALJ Decision cites Petitioner's Exhibit 31, at 9-10; however, the assessment of the resident's physical functioning appears at pages 7-8 of that exhibit.

29. Moreover, since the incident occurred in the bathroom, it is reasonable to infer that the aide was attempting to toilet the resident, which was an activity for which the assessment also indicated that the resident needed a two-person assist.

30. The ALJ actually referred to this survey as the January survey; however, it is clear in context that she intended to refer to the November survey, which was the basis for the $1,150 per day CMP for the period November 5 through December 9, 1999.

31. Section 488.438(d) provides that [r]epeated deficiencies are deficiencies in the same regulatory grouping of requirements found at the last survey, subsequently corrected, and found again at the next survey." (This definition was originally published in 1994, inadvertently omitted when the regulations were republished in 1999, and later restored. See 68 Fed. Reg. 46,036, 46,067 (August 4, 2003).) Section 7516C.3 of the SOM limits repeated deficiencies to those found in standard or abbreviated standard surveys. Under this provision, the pressure sore deficiency findings in November 1999 and January 2000 did not result in a repeated deficiency since the November 1999 survey was a complaint survey.

32. Harmony Court may have misconstrued the statement in Lebanon that "even if the disputed facts were not material on the issue of substantial compliance, a finding in Lebanon's favor on the disputed facts would affect evaluation of the degree of culpability . . . ." At 14. This simply indicates that there may be some evidence going to the issue of culpability that is not material to the issue of substantial compliance.