SUBJECT: Windsor Health Care Center,

Petitioner,

Centers for Medicare & Medicaid Services

FINAL DECISION ON REVIEW OF
ADMINISTRATIVE LAW JUDGE DECISION

On September 15, 2003, Windsor Health Care Center (Windsor) appealed a July 10, 2003 decision by Administrative Law Judge (ALJ) Carolyn Cozad Hughes. Windsor Health Care Center, DAB CR1066 (2003) (ALJ Decision). The ALJ Decision upheld a civil money penalty (CMP) imposed on Windsor by the Centers for Medicare & Medicaid Services (CMS) for noncompliance with the Medicare participation requirement in 42 C.F.R. § 483.25(h)(2). As explained below, we agree with the ALJ that CMS presented a prima facie case that Windsor was not in substantial compliance with section 483.25(h)(2) from November 30, 2000 to December 21, 2000, and that Windsor failed to raise a genuine issue of material fact concerning that prima facie case. We also find no basis to disturb the ALJ's finding that the amount of the CMP was reasonable. We therefore affirm the ALJ Decision in its entirety and sustain the CMP of $11,500.

Regulatory Background

Windsor is a skilled nursing facility (SNF) that participates in the Medicare program. Medicare's participation requirements for SNF 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." 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 CMP may be imposed against a facility that is not in "substantial compliance" with one or more participation requirements. 42 C.F.R. § 488.408(d). A facility is not in "substantial compliance" with a participation requirement if it is found to have a deficiency that results in actual harm to a resident or poses a risk of more than minimal harm to resident health and safety. 42 C.F.R. § 488.301. 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).

Case Background

The following background information is drawn from the ALJ Decision and the record before the ALJ.

The Ohio Department of Health (ODH) conducted a standard survey of Windsor in November 2000. During that survey, ODH determined that Windsor had failed to provide adequate supervision to Resident 49 on July 24, 2000 and was therefore not in substantial compliance with 42 C.F.R. § 483.25(h)(2), which requires a facility to ensure that each resident "receives adequate supervision and assistance devices to prevent accidents." ⁽¹⁾ See CMS Ex. 3, at 10-11. ODH also found that Windsor had failed to provide adequate supervision to Resident 57 on November 28, 2000. Id. at 11.

On January 23, 2001, CMS issued a Notice of Imposition of Remedies. CMS Ex. 1. The notice advised Windsor that it was not in substantial compliance with Medicare and Medicaid participation requirements, and that some of the cited deficiencies had resulted in actual harm to residents. CMS also advised Windsor of its decision to impose a $550 per day CMP effective November 30, 2000.

A revisit survey was performed on December 21, 2000. Based on the findings of that survey, CMS determined that Windsor had achieved substantial compliance as of December 21, 2000. See CMS Ex. 2. Accordingly, CMS informed Windsor that the total CMP imposed was $11,500 (equal to $550 per day for the 21 days from November 30 to December 21). Id.

Windsor appealed CMS's determination to the ALJ. Following an exchange of documents, CMS filed a motion for summary judgment, asking the ALJ to affirm the $11,500 CMP based on Windsor's alleged failure to provide adequate supervision to Residents 49 and 57. In support of its motion, CMS submitted facility records and the declarations of two ODH surveyors who participated in the November survey as well as the declaration of a CMS employee responsible for addressing issues relating to the Resident Assessment Instrument/Minimum Data Set (RAI/MDS), a tool used by facilities to collect and standardize information about a resident's clinical problems and functional status. Motion for Summary Judgment (MSJ) Exs. A, B, and C.

ALJ Decision

The ALJ determined that CMS had made a prima facie showing that Windsor had failed to provide Residents 49 and 57 with adequate supervision to prevent accidents, and that Windsor had "proffer[ed] no set of facts which, if accepted, would establish that it was in substantial compliance with 42 C.F.R. § 483.25(h)(2)[.]" ALJ Decision at 4-11. The ALJ also found that summary judgment was appropriate because Windsor had failed to "tender evidence of specific facts to support its contention" that there were genuine disputes of material fact. Id. at 6. Finally, the ALJ found that the amount of the CMP imposed for Windsor's noncompliance was reasonable. Id. at 11-12.

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. Whether summary judgment is appropriate is a legal issue that we address de novo, viewing the proffered evidence in the light most favorable to the non-moving party. See Carrier Mills Nursing Home, DAB No. 1883 (2003).

On the issue of whether a remedy is authorized, CMS is entitled to summary judgment if it has (1) made a prima facie showing that the petitioner was not in substantial compliance with one or more Medicare participation requirements, and (2) demonstrated that there is no dispute about any material fact supporting its prima facie case and that it is otherwise entitled to judgment as a matter of law. ⁽²⁾ Carrier Mills. CMS is not entitled to summary judgment if the petitioner has proffered evidence that would permit an ALJ to conclude that it was in substantial compliance with the participation requirements during the relevant period. Id.

Discussion

In its request for review, Windsor stated that it was appealing each and every finding in the ALJ Decision. Request for Review (RR) at 1. In particular, Windsor asserted that factual disputes, discrepancies, and uncertainties precluded summary judgment on the issue of whether Residents 49 and 57 received inadequate supervision in violation of section 483.25(h)(2). Windsor also contended that the CMP imposed by CMS was unreasonable in any event. We address each of these issues in turn below.

1. Whether CMS is entitled to summary judgment concerning the deficiencies involving Residents 49 and 57.

Section 483.25(h)(2) provides that a facility "must ensure" that "each resident receives adequate supervision and assistance devices to prevent accidents." In Woodstock Care Center, we analyzed the wording, context, and history of section 483.25(h)(2) and, based on that analysis, set out a framework for evaluating allegations of noncompliance with that requirement. Woodstock Care Center, DAB No. 1726, at 25-30 (2000)(citing 54 Fed. Reg. 5316, 5332 (February 2, 1989)), aff'd Woodstock Care Ctr. v. Thompson, No. 01-3889 (6^th Cir. 2003). We determined that although section 483.25(h)(2) does not hold a facility strictly liable for accidents that occur, it does require the facility to take reasonable steps to ensure that a resident receives supervision and assistance devices designed to meet his or her assessed needs and to mitigate foreseeable risks of harm from accidents. Id.; see also Odd Fellow and Rebekah Health Care Facility, DAB No. 1839 (2002). A facility is permitted the flexibility to choose the methods it uses to prevent accidents, but the chosen methods must constitute an "adequate" level of supervision under all the circumstances. See Woodstock Care Center. What is "adequate" supervision depends, of course, on the resident's ability to protect himself or herself from harm. Id. ⁽³⁾

a. Resident 49

The Statement of Deficiencies (SOD) for the November survey states that on July 24, 2000, during the 3:00 p.m.-to-11:00 p.m. shift, a nurse aide, Gail Gordon, wheeled Resident 49 into her room "in a hurried manner, bumping [her right] leg on the footboard of the bed." CMS Ex. 3, at 11. The SOD also states that Resident 49 sustained a fractured tibia that "was discovered on July 26, 2000, after the resident complained of pain in that leg and an x-ray study was completed." ⁽⁴⁾ Id.

Facility records show that on July 27, 2000, Windsor initiated an investigation to determine the cause of Resident 49's injury. See CMS Ex. 20, at 3. The findings of that investigation are contained in a July 31, 2000 report that Windsor submitted to ODH. Windsor Ex. 7, at 8.

As the ALJ found, the record contains differing or conflicting accounts of the July 24 incident. See ALJ Decision at 1. The first of these accounts is the one set forth in the SOD. That account is based largely on statements made by Resident 49 to a Windsor social worker on July 27, 2000. See CMS Ex. 20, at 1; Windsor Ex. 7, at 4-5. The social worker provided the following written account of these statements:

Social Services asked [Resident 49] what happened to her leg. At first she said that she rolled her wheelchair against her foot board. Social Services asked [her] how is that possible when you don't wheel your own wheelchair.

[Resident 49] then began to tell me what happened. She said on Monday between 7:00 p.m./8:00 p.m. Gail [Gordon] rolled her from the smoking room. She was going fast, rolled her into the room and ran into the foot board on the bed. [Resident No. 49] says they both heard a bone crack. Gail told [Resident No. 49] that she didn't mean to do it. [Resident No. 49] told her she was alright.

According to [Resident No. 49], Gail then put her into bed. [Resident No. 49] says Gail was rough with her. [Resident No. 49] then said that she was in pain. She says that Gail started to yell at her. Gail said it doesn't hurt as bad as you pretend. [Resident No. 49] says she yelled so loud people outside heard. She knows this because [Resident No. 54] came in to check on her. He heard the yelling. Her window was cracked.

[Resident No. 49] says that Gail is telling people [Resident No. 54] was pushing her and did this.

CMS Ex. 20, at 1.

A second account is based on Nurse Aide Gordon's written statement. See CMS Ex. 20, at 2; Windsor Ex. 7, at 10. Nurse Aide Gordon said in this statement:

[Resident No. 49] was in South Feeding Lounges smoking. About 6:50 p.m., she was ready to go to bed. [Resident No. 54 ⁽⁵⁾] started pushing her, I told him to stop because he was running her into the wall.

I took her to her room, and I pushed her in the room. I pushed [Resident No. 49]'s bed over by the window, so I could get around to put her in bed.

She said the wheel bump (sic) the bed, I did not see that. She said her leg was hurting. I reported it to the nurse so that she could come and look at it.

Windsor Ex. 7, at 10.

A third account appears in an investigator's report of an interview with Nurse Aide Gordon (conducted before she prepared her written statement). See CMS Ex. 21, at 5. During that interview, Gordon stated that Resident 54 pushed Resident 49's wheelchair into the room and wedged it between two beds. When she (Gordon) tried to unwedge Resident 49, the wheelchair hit the footboard of the bed. Gordon stated that she immediately reported the incident to the duty nurse, Pearl Strong.

An incident report prepared by Nurse Strong on July 24, 2000 states that Resident 49's condition before the incident was "normal," that the incident occurred in her room, and that the incident involved a wheelchair. Windsor Ex. 7, at 3. Nurse Strong stated that "[a]n aide came to me and said while she was putting resident to bed the wheelchair hit the side of bed." Id. Nurse Strong also stated that she assessed Resident 49's leg but found no bruising, redness, or swelling. Id. In addition, she stated that she gave Resident 49 pain medication. Id.; see also CMS Ex. 21, at 5.

Nursing notes for July 24 and July 25 do not mention Resident 49 being injured or in pain. See CMS Ex. 21, at 7 and Ex. 20, at 4. However, notes for July 26 indicate that she complained of right lower leg pain and told the staff that she had bumped her leg "the other day." CMS Ex. 20, at 4.

Windsor's July 31, 2000 investigative report concluded that abuse, neglect, or misappropriation was "suspected" but could not be verified, and the "wrongdoer could not be determined." Windsor Ex. 7, at 9. Other facility records show that on July 31, 2000, Windsor issued Nurse Aide Gordon a verbal warning for yelling at residents, noting that there had been complaints by residents and staff that she was "abrupt" and "rough." CMS Ex. 21, at 1. Windsor also issued Gordon a written warning for transporting an unnamed resident in a careless manner. Id.

In response to CMS's summary judgment motion, Windsor contended that the surveyor declarations submitted by CMS constituted inadmissible hearsay, were based on facility records that CMS did not produce, and thus were not adequate to support a summary judgment motion. Response to MSJ, at 2-4. Windsor also contended that CMS failed to demonstrate any noncompliance in part because none of its declarants asserted that the facility departed from "professionally accepted standards of care." Id. at 9-10. In addition, Windsor asserted that there was "substantial evidence" negating CMS's assertions of noncompliance. Id. at 9. However, it did not discuss or further identify this evidence, except to say that it was contained in or attached to a statement that it submitted in connection with informal dispute resolution (IDR) proceedings. ⁽⁶⁾ Id. at 9.

The ALJ concluded:

The evidence thus sets forth several possible scenarios resulting in Resident No. 49's broken leg. Although the details and emphasis vary, the scenarios are generally consistent. In none of her statements did NA Gordon deny that, while under her care, Resident No. 49's leg bumped the footboard, which most likely caused the fracture. Either she herself carelessly pushed the resident's wheelchair, or she allowed Resident No. 54 to push the wheelchair in a reckless fashion, or both. I agree with CMS that no matter which of these incidents resulted in the resident's leg fracture, the facility was not exercising an adequate degree of supervision. Under none of the proffered scenarios did the facility do everything in its power to prevent the accident.

ALJ Decision at 10 (footnotes omitted).

We fully agree with the ALJ's analysis and conclusion. CMS proffered evidence showing that one of the following occurred: Nurse Aide Gordon propelled Resident 49's wheelchair in a careless manner and in so doing bumped the wheelchair against her bed; while Resident 49 was sitting in her wheelchair, Nurse Aide Gordon caused the bed to bump her wheelchair; or Nurse Aide Gordon permitted Resident 54 to carelessly push Resident 49's wheelchair. It is undisputed that in each of these scenarios, Gordon was exercising direct and immediate control over Resident 49 while she was in the wheelchair. Because Resident 49 was under her control, it is reasonable to infer that Gordon could have refrained from propelling Resident 49's wheelchair in a careless or negligent manner, could have moved the bed without causing a collision with the wheelchair, or could have prevented Resident 54 from carelessly moving the wheelchair. In each set of circumstances, Nurse Aide Gordon did not do all that she could have done to adequately supervise Resident 49.

In its request for review, Windsor did not dispute any particular factual assertion made by CMS or contend that CMS's evidence contained material inaccuracies, omissions, or misrepresentations. Instead, it contended that there can be no determination about whether Nurse Aide Gordon provided inadequate supervision until it is conclusively determined how the accident occurred. RR at 7. We do not agree because CMS established that Gordon provided inadequate supervision under any of the scenarios for which there was evidence in the record. Moreover, CMS was not required to rule out every possible or conceivable cause of Resident 49's injury because the basis for the deficiency finding is Windsor's failure to provide adequate supervision, not its failure to prevent the accident that actually occurred.

Further proceedings to determine how the accident occurred might have been necessary if Windsor had offered evidence of other factual scenarios warranting a finding of substantial compliance. Windsor offered no such evidence. Further proceedings would also have been necessary if it were reasonable to conclude that the proffered facts and evidence failed to demonstrate noncompliance. However, Windsor did not explain how Nurse Aide Gordon's supervision could be considered adequate under any of the scenarios outlined above. The decision to reprimand Nurse Aide Gordon suggests that Windsor had itself concluded that Gordon had transported Resident 49 in an unsafe manner or otherwise failed to safeguard her from injury while she was in her wheelchair. ⁽⁷⁾

Windsor asserted that Resident 49 may have "slipped in an unforeseeable manner, bumped herself against the bed in an unpredictable manner." RR at 7. It does not, however, say what evidence or facts support this conjecture. ⁽⁸⁾ There is, in fact, no evidence that the contact between bed and wheelchair was caused in any manner other than by Resident 54 or Nurse Aide Gordon pushing the wheelchair into the bed, or by Gordon pushing Resident 49's bed into the wheelchair. Windsor's mere speculation that the accident occurred under other circumstances is insufficient to create a genuine issue of material fact. See Carrier Mills.

Windsor also suggested that Resident 49's injury may have been self-inflicted, relying on a statement that she gave to the social worker on July 27, 2000. As indicated, Resident 49 initially stated to the social worker that she had propelled her wheelchair against the footboard. CMS Ex. 20, at 1. However, she ultimately asserted, with factual detail, that her contact with the footboard had been caused by Nurse Aide Gordon propelling the wheelchair in a careless or negligent manner. Windsor offered no evidence to rebut Resident 49's statement concerning Gordon's conduct. Nor did it proffer evidence that Resident 49 was, in fact, capable of propelling her own wheelchair. Given these circumstances, and given that Gordon herself did not blame Resident 49 for the accident, Resident 49's initial statement to the social worker that she (Resident 49) had caused the accident is not enough to raise a genuine issue of material fact.

Windsor suggested that CMS failed to prove noncompliance with section 483.25(h)(2) because it offered no evidence that Resident 49's accident was foreseeable. However, it is plainly foreseeable that a wheelchair-bound resident might be injured if the wheelchair is propelled by the nursing staff in a careless or negligent manner, or if another resident is allowed to do so, or if the wheelchair is negligently permitted to collide or make contact with a wall, bed, or other object. For its part, Windsor offered no evidence that the accident was unforeseeable or occurred in a manner that it was powerless to prevent.

Windsor also suggested that holding it liable for Resident 49's injury constitutes imposition of strict liability. RR at 4-5. However, the ALJ found, as do we, that Windsor was not in substantial compliance with section 483.25(h)(2) not because it failed to prevent the accident, but because the undisputed facts showed that Nurse Aide Gordon failed to provide Resident 49 with adequate supervision to mitigate a foreseeable risk of harm.

In short, CMS proffered undisputed facts and evidence demonstrating that Windsor failed to supervise Resident 49 adequately on November 24, 2000. Windsor did not allege or show that a different conclusion can reasonably be drawn from the undisputed facts. Nor did it show that there are material facts in dispute. Finally, it did not proffer any evidence that the supervision was adequate under any of the factual scenarios revealed by the evidence. We therefore find that CMS made a prima facie showing that Windsor was not in substantial compliance with section 483.25(h)(2) in its care of Resident 49, and that CMS is entitled to summary judgment regarding this part of its case.

b. Resident 57

Facility records and other documents submitted by CMS indicate that on November 28, 2000, two nurse aides helped Resident 57 transfer to a shower chair. MSJ Ex. B, ¶ 10. One aide then left the shower area, while the other remained to conduct the shower. Id. During the shower, Resident 57 began to fall forward, the aide tried to secure her, but both she and the aide fell to the floor. Id. Resident 10 sustained a laceration that required stitches. CMS Ex. 22, at 1.

Resident 57's plan of care indicates that she had Alzheimer's disease, glaucoma, cataracts, scoliosis (curvature of the spine), and a left knee contracture. CMS Ex. 24, at 11. She also had a "severe" cognitive impairment, was at risk for falls, was unaware of safety issues, could not make her needs known, could not understand others, and could be "resistive to care." Id. at 10-11.

Resident 57's November 6, 2000 comprehensive assessment indicates that she could not demonstrate standing or sitting balance without physical assistance from others. Windsor Ex. 8, at 7. The comprehensive assessment also indicates that she received the assistance of two or more persons for transfers, bed mobility, dressing, and bathing. Id. Resident 57's plan of care states that she was dependent on staff for all activities of daily living and required two or more persons to help her with transfers. CMS Ex. 24, at 10-11. In addition, the plan of care indicates that the staff was to provide her with "total care" for dressing, toilet use, personal hygiene, and bathing. Id. at 10. The plan does not define "total care" or indicate how many persons were supposed to help her bathe or shower. CMS Ex. 24, at 10.

Surveyor Darlene Eddinger, R.N. stated in a declaration that she reviewed the facility's records regarding the incident, including nursing notes, the plan of care, and the comprehensive assessment (which she referred to as the MDS). MSJ Ex. B, ¶¶ 5-6. She noted that the comprehensive assessment described Resident 57 as totally dependent on staff for conducting her bath or shower and as needing the help of two or more persons for that activity. Id. ¶ 9. Nurse Eddinger also noted that Resident 57 "did not have much control over moving her body," as evidenced by her inability to reposition herself in bed without the help of two or more persons. Id. ¶ 13. In Nurse Eddinger's estimation, Resident 57 could not sit safely upright in a shower chair given her mobility deficit, knee contracture, and scoliosis, and her "lack of awareness for her own safety also contributed to the precariousness of her sitting in a shower chair." Id. ¶ 14. Based on Resident 57's debilitated clinical condition and the findings in the comprehensive assessment, Nurse Eddinger concluded that two or more persons were necessary to safely conduct her shower or bath. Id. ¶ 16.

Pauline Swalina, R.N., a CMS Health Quality Review Specialist who serves as a regional coordinator for the Resident Assessment Instrument/Minimum Data Set (RAI/MDS) program, echoed Nurse Eddinger's statements concerning the contents of the comprehensive assessment. MSJ Ex. C, ¶ 5. Nurse Swalina stated in her declaration that two or persons were needed to help Resident 57 with the shower because of (1) her inability to control body movements, (2) her inability to be tested for sitting or standing balance without physical help, (3) her lack of safety awareness, and (4) her other conditions, including scoliosis and knee contracture. Id. ¶¶ 7-11. These factors, said Nurse Swalina, indicate that "her sitting in a shower chair was a precarious situation placing her at risk for falls." Id. ¶ 11. Nurse Swalina also asserted that use of the term "total care" in the plan of care meant that Resident 57 was to have "the physical assistance of two or more persons during her shower time[.]" Id. ¶ 7. Commenting on the plan of care's failure to define precisely what was meant by "total care," Nurse Swalina stated that "I would have expected that [Resident 57's] ADL care plan [would have] specifically instruct[ed] staff that two or more persons were necessary to perform this resident's shower." Id. ¶ 13.

Windsor's exhibits include an unsigned and undated handwritten note stating that Resident 57 "was a two person assist for transfers only -- not for hands on care[,]" and that a "two-person assist was provided for the transfer but not the actual shower which is the realm of her care plan." Windsor Ex. 8, at 1 (emphasis in original). In its written response to the summary judgment motion, Windsor did not discuss the handwritten note or address whether the alleged circumstances surrounding Resident 57's fall constituted a failure to comply with section 483.25(h)(2). Instead, it asserted that the "positions and documents outlined" in its IDR statement demonstrated that "material issues of fact remain." Response to MSJ, at 9. Windsor also suggested that CMS had failed to make a prima facie showing of noncompliance because it had made certain unspecified "erroneous assumptions," because it failed to "prove that the scope and severity assigned" to the alleged deficiency was appropriate, and because none of the surveyors "attest[ed] to a departure from professionally accepted standards of care." Id. at 4, 9-10. Finally, Windsor suggested that the surveyor's notes and declarations, to the extent that they constituted hearsay, were unreliable and inadmissible and thus could not be used to support a motion for summary judgment. Id. at 8-9.

The ALJ found that the handwritten note submitted by Windsor "falls short of the type of declaration generally required to establish a genuine dispute of fact for summary judgment purposes." ALJ Decision at 10. Then, referring to a statement in Windsor's plan of correction that Resident 57's comprehensive assessment was a "recapitulation of the highest form of assistance required in the past seven days, not necessarily required at all times" (see CMS Ex. 3, at 11 (emphasis in original)), the ALJ stated that she would "resolve any apparent conflict between the MDS [the comprehensive assessment] and [Windsor's] other statements in [Windsor's] favor, and find that Resident 57's care plan requires a two-person assist for transfers only, and not for the resident's actual shower." Id. The ALJ then found:

the record before me shows a seriously compromised individual, who was at high risk for falls, and suffered a serious fall while in the shower. The question then is: what was the facility doing to prevent accidents to this vulnerable individual, particularly while she was bathing. For its part, Petitioner presents neither declarations nor documentary evidence to counter CMS's case. Petitioner does not even specify which of the specific facts set forth in CMS's materials it challenges (if any). Petitioner has not proffered evidence that would permit me to conclude that it provided Resident No. 57 with adequate supervision and assistance devices to prevent accidents.

ALJ Decision at 11. Based on these findings, the ALJ concluded that CMS had made a prima facie showing that Windsor was not in substantial compliance with 42 C.F.R. § 483.25(h)(2) when it attempted to shower Resident 57 on November 28, 2000, and that CMS was entitled to summary judgment on that element of the case.

We fully agree with the ALJ that summary judgment was appropriate. Section 483.25(h)(2) required Windsor to provide an "adequate" level of staff supervision -- that is, a level of supervision reasonably designed to meet the resident's needs and functional capacity (as reflected in the comprehensive assessment and plan of care), and that, together with the use of assistance devices, addressed the foreseeable risk of injury or harm from accidents. In this case, it is undisputed that Resident 57 was severely debilitated, that she received or needed the help of two or more persons to perform certain activities of daily living, that she was sometimes resistive to care, and that she could not maintain standing or sitting balance by herself during testing. It is also undisputed that only one nurse aide was helping Resident 57 shower on November 28, 2000, even though her comprehensive assessment indicated that two or more persons had helped her with that activity in the recent past.

In its request for review, Windsor failed to identify a genuine issue of material fact. It suggested only, through various statements, that CMS had failed to prove a violation of section 483.25(h)(2) as a matter of law. For example, it asserted that "the amount of care [rendered] under the circumstances (i.e., one person) was proper assuming that the person was properly supervising [Resident 57] and/or that assistive devices were in use." RR at 8 (emphasis added). However, Windsor did not offer or identify any evidence that the aide had "properly" supervised Resident 57 or used assistance devices. In particular, it proffered no evidence about the aide involved, how the shower was actually conducted, or the techniques or devices used by the aide to maintain Resident 57's stability in the shower. In addition, Windsor did not allege that the fall occurred under abnormal or unforeseeable circumstances. Windsor also failed to proffer any evidence about what the plan of care meant by "total care" (if different from a two-person assist) or whether the aide was providing "total care" at the time of the fall.

Windsor asserted that "it is apparent that the supervision provided to [Resident 57] was adequate to the point that even staff who tried to secure [Resident 57] from falling actually fell with her." RR at 8. We are not certain what this statement means. If it is a contention that the supervision could be deemed adequate merely because the aide fell to the floor with Resident 57, Windsor did not explain how this fact shows that the aide was providing adequate supervision. As indicated, Windsor proffered no facts or evidence about how the aide conducted Resident 57's shower.

Windsor vaguely suggested that the accident was unforeseeable, noting that section 483.25(h)(2) "does not mandate that staff prevent the resident from hitting the floor under all circumstances." RR at 8. However, the risk of Resident 57 falling from a seated position in the shower was clearly foreseeable given her documented balance deficits and other impairments. Windsor offered no evidence that Resident 57 fell under unusual or unforeseeable circumstances.

Windsor also asserted that Resident 57 fell despite "one-on-one" supervision and "could have fallen even if two persons (or three, or more) were there, even if (hypothetically) the resident was surrounded (in the shower) with padded mats and a bevy of nurse aides." RR at 9. These assertions are immaterial because the basis for the finding of noncompliance is not the occurrence of the accident per se but Windsor's failure to provide adequate supervision to prevent accidents.

Windsor suggested, again without argument, that a deficiency finding stemming from this incident is the product of an "outcome oriented approach" not permitted by the regulations. RR at 9. However, in Woodstock Care Center, we indicated that inferring a lack of adequate supervision from certain outcomes is, under appropriate circumstances, consistent with legislative intent and with the facility's overarching duty, under section 483.25, to provide a resident with 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" (emphasis added). ⁽⁹⁾ Consistent with that overarching duty, we said that section 483.25(h)(2) imposes on facilities an affirmative duty designed to achieve favorable outcomes to the highest practicable degree. Woodstock Care Center.

Finally, Windsor asserted that the "only material" in the record concerning the accident was Nurse Eddinger's "hearsay declaration." RR at 8. Windsor suggested that this declaration, which was based in part on the contents of the facility's own investigative report, is unreliable, and that the investigative report should have been submitted by CMS as the "best evidence" of what actually happened. Id. We find no merit to this objection because the investigative report is in Windsor's possession and could have been produced to show any discrepancies.

Because CMS made a prima facie showing that Windsor was not in substantial compliance with section 483.25(h)(2) in its care of Resident 57, and because Windsor failed to raise any genuine dispute of material fact concerning that prima facie case or proffer evidence affirmatively showing that Resident 57 received adequate supervision, we affirm the ALJ's finding that CMS was entitled to summary judgment regarding this deficiency finding.

2. Whether the ALJ erred in finding that the amount of the CMP was reasonable.

We held in CarePlex of Silver Spring, DAB No. 1683 (1999) that an ALJ's assessment of whether the amount of the CMP is reasonable must be guided by the factors specified in (or cross-referenced by) 42 C.F.R. § 488.438(f). 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. CarePlex. The ALJ's evaluation of the CMP must be an independent determination about "whether the evidence presented on the record concerning the relevant regulatory factors supports a finding that the amount of the CMP is at a level reasonably related to an effort to produce corrective action by a provider with the kind of deficiencies found and in light of the other factors involved (financial condition, facility history, and culpability)." Id. at 8.

The ALJ's analysis fully complies with the standards established by Careplex. The ALJ determined that the $550 per day CMP, which she noted was at the "lower end" of the mandatory penalty range for non-immediate jeopardy deficiencies, was reasonable in part because the deficiencies were "serious" and because the facility was "culpable." ALJ Decision at 12. In addition, the ALJ took note of evidence that Windsor had been cited previously (in 1999) for noncompliance with section 483.25(h)(2) and that this prior deficiency had resulted in actual harm to a resident. Id. The ALJ also noted that CMS had submitted evidence of Windsor's solvency, including an income statement showing a net operating profit of $37,924 for calendar year 1999. Id. Finally, the ALJ remarked that in considering all the relevant factors, "I would not find unreasonable CMS's determination to impose a CMP that is significantly higher than the mandatory minimum." Id.

Windsor asserted that the ALJ departed from her "neutral fact-finding role" by finding that the deficiencies were more serious than CMS alleged them to be. RR at 10. Windsor also stated that the ALJ "seemingly fault[ed] CMS for failing to impose a higher CMP than the $11,500 CMP sought by CMS for two non-immediate jeopardy' citations." RR at 9. These contentions provide no basis to disturb the ALJ's conclusion. The ALJ did not find that the deficiencies were more serious than CMS found them to be, only that a CMP "significantly higher than the mandatory minimum" was reasonable based on all the relevant factors. This statement is an implicit finding that the CMP actually imposed by CMS was reasonable. In any event, Windsor did not assert that the CMP imposed was unreasonable based on the factors considered by the ALJ. Nor did it challenge any of her factual findings concerning the relevant regulatory factors.

Windsor also suggested that it lacked the financial resources to pay the CMP, contending that the $11,500 CMP was "more than a third of the facility's operating profit for an entire year." However, the fact that the CMP was a significant percentage of annual operating profit does not establish that Windsor lacked the ability to pay it. The key factor in assessing financial condition is whether the facility has adequate assets to pay the CMP without having to go out of business or compromise resident health and safety. See Wisteria Care Center, DAB No. 1892, at 12-13, n.6 and 7 (2003). Windsor presented no evidence about its assets or about any other factor relevant to its financial condition. We therefore find no basis to conclude that the ALJ failed to give adequate consideration to Windsor's financial condition in determining whether the amount of the CMP was reasonable.

Conclusion

For the reasons above, we affirm the ALJ's determination that summary judgment in favor of CMS was appropriate on the issue of whether there was a basis for the CMP. We also affirm the ALJ's finding that the amount of the CMP was reasonable. Accordingly, we sustain the $11,500 CMP imposed by CMS.

Cecilia Sparks Ford

Judith A. Ballard

Donald F. Garrett
Presiding Board Member

1. ODH cited Windsor for violations of other participation requirements, but these other deficiencies are not issue in this case.

2. These criteria are consistent with our holdings concerning the burden of proof in cases brought under 42 C.F.R. Part 498 to enforce compliance with participation requirements for SNFs and other long term care facilities. The applicable burden of proof requires CMS to come forward with sufficient evidence on disputed facts that together with the undisputed facts will establish a prima facie case that the facility is not complying with one or more participation requirements. The facility may rebut a prima facie case of noncompliance by showing, by a preponderance of the evidence, that it is in substantial compliance with participation requirements. Hillman Rehabilitation Center, DAB Nos. 1611 (1997), and 1663 (1998); aff'd, Hillman Rehabilitation Center v. United States, No. 98-3789(GEB) (D.N.J. May 13, 1999); Cross Creek Health Care Center, DAB No. 1665 (1998) (same framework applies in long-term care facility cases involving CMPs).

3. In addition to citing Woodstock, the ALJ here cited the statement from Asbury Center at Johnson City, DAB No. 1815, at 12 (2002) that "a facility must do everything in its power to prevent accidents." ALJ Decision at 6-7. Windsor argued that this language imposed a requirement not contained in the regulation, which requires only "adequate supervision." RR at 4. Although the statement from Asbury Center does not track the wording of the regulation, it is clear from the ALJ's analysis that she applied the applicable regulatory standard, which, as discussed in Woodstock (and in the text above), requires a facility to provide "adequate supervision" and assistance devices to mitigate foreseeable risks of harm from accidents. We in any event apply the regulatory standard in our review of the ALJ Decision.

4. According to surveyor notes, the fracture was described as an "oblique undisplaced spiral fracture of the distal shaft of the tibia." CMS Ex. 21, at 3. The tibia is the larger of two bones in the segment of the leg between the knee and ankle. MSJ Ex. A, ¶ 8.

5. See CMS Ex. 7, at 4 (Resident Roster). There is evidence, not rebutted by Windsor, that Resident 54 had a cognitive impairment, non-dementia mental illness, and associated behavioral symptoms. Id. That evidence also shows that Resident 54 took psychoactive medication, had contractures or limited range of motion, and had a communication problem. Id. Resident 54 was questioned during the facility's investigation of incident, and he denied pushing Resident 49 in her wheelchair on July 24, 2000 (or ever). CMS Ex. 21, at 4.

6. The ALJ determined that Exhibits 3 and 24 were the documents to which Windsor was referring. See ALJ Decision at 6, n.3.

7. Windsor asserted that the incident involving Resident 49 was not an "accident" within the meaning of the regulations. RR at 5. However, it failed to make any argument supporting this assertion. The term "accident" is defined in the State Operations Manual (SOM) as an "unexpected, unintended event that can cause a resident bodily injury." See CMS Ex. 31 (excerpt from App. P of the SOM)). All of the evidence and facts suggest that the incident was unexpected or unintended. In any event, we have held that the occurrence of an accident is not prerequisite to finding noncompliance under section 483.25(h)(2). Woodstock Care Center.

8. The available evidence contradicts this hypothesis. A review of Resident 49's comprehensive assessment and other records indicated that she was not ambulatory and needed the help of two persons to transfer from wheelchair to bed. See MSJ Ex. A, ¶ 7. Thus, it is unlikely that she "slipped." Furthermore, because she was not cognitively impaired and was presumably aware of her limitations, it is unlikely that she attempted to transfer herself without assistance. See id.

9. In Woodstock Care Center (at 25, n.11), we noted that "where [CMS] inferred from certain results that Woodstock was not providing adequate supervision, Woodstock had an opportunity to rebut that inference with persuasive evidence that it was providing supervision that was adequate under the circumstances , but failed to do so." In this case, Windsor similarly failed to proffer facts that show, or support an inference, that its supervision was adequate under the circumstances.