SUBJECT:

Woodward Hills Nursing Center,

Petitioner,

Centers for Medicare & Medicaid Services

DECISION

BACKGROUND

On July 22, 2000, Resident #1, who was restrained in a wheelchair, propelled herself out the lobby doors of the facility and sustained a fall. A visitor to the facility discovered Resident #1 lying on the pavement, still restrained in the wheelchair. The resident was bleeding from her nose and had suffered lacerations to the left eye and left arm and an abrasion of the left palm. Following the incident, Resident #1 was transported to the hospital, where she was admitted. Responding to the facility's report of this incident, the Michigan Department of Consumer and Industry Services (hereafter "State Agency") conducted a complaint investigation survey on August 8, 2000. Following the survey, the State Agency found the facility out of compliance with the requirement for Quality of Care, 42 C.F.R. � 483.25(h)(2) (Tag F-324). The State Agency notified Petitioner and CMS of its findings in a Statement of Deficiencies (SOD) forwarded to Petitioner by letter dated August 31, 2000. CMS Ex. 1.

By letter dated September 5, 2000, CMS advised Petitioner that CMS was imposing a PICMP of $1,500 based on the noncompliance found at the August 8, 2000 survey. CMS also stated it would impose a denial of payment for new admissions, effective November 8, 2000, if the facility failed to achieve substantial compliance with program requirements by that date. CMS Ex. 2. The facility responded with a plan of correction dated September 12, 2000. In response, the State Agency conducted a revisit survey on October 3, 2000. By letter dated November 8, 2000, CMS confirmed that the facility had been found in substantial compliance as of September 26, 2000. CMS Ex. 3.

Petitioner timely requested a hearing to challenge CMS's determination of noncompliance, and the case was assigned to me for a hearing and decision. The parties filed pre-hearing briefs, with proposed exhibits and lists of proposed witnesses. I directed CMS to file a reply brief. Upon the completion of the briefing, the parties waived an in-person hearing. Accordingly, I have decided this case based on the parties' submissions. ⁽²⁾

ISSUES

1. Whether the facility was out of substantial compliance with program participation requirements, specifically 42 C.F.R. � 483.25(h)(2) (Quality of Care).

2. If the facility was not in substantial compliance, whether the $1,500 PICMP imposed is reasonable.

STATUTORY AND REGULATORY BACKGROUND

To participate in the Medicare program, a nursing facility must maintain substantial compliance with program requirements. To be in substantial compliance, a facility's deficiencies may pose no greater risk to resident health and safety than "the potential for causing minimal harm." 42 C.F.R. � 488.301.

Under the "quality of care" requirement, each resident must receive and a 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 resident's comprehensive assessment and plan of care. 42 C.F.R. � 483.25. Specifically, a facility must ensure that: 1) the resident environment remains as free of accident hazards as possible; and 2) each resident receives adequate supervision and assistance devices to prevent accidents. 42 C.F.R. � 483.25(h).

If a facility is not in substantial compliance with program requirements, CMS has the authority to impose one or more of the enforcement remedies listed in 42 C.F.R. � 488.406, which include imposing a civil money penalty (CMP). See Act, section 1819(h). CMS may impose a CMP for each instance that the facility is not in substantial compliance with program requirements (PICMP). 42 C.F.R. � 488.430(a). When CMS imposes a PICMP for an instance of noncompliance, the penalties range from $1,000 to $10,000 per instance. 42 C.F.R. � 488.438(a)(2).

In setting the amount of the CMP, CMS considers: 1) the facility's history of noncompliance; 2) the facility's financial condition; 3) the factors specified in 42 C.F.R. � 488.404; and 4) the facility's degree of culpability, which includes neglect, indifference, or disregard for resident care, comfort, or safety. The absence of culpability is not a mitigating factor. 42 C.F.R. � 488.438(f). The factors found at 42 C.F.R. � 488.404 include: 1) the scope and severity of the deficiency; 2) the relationship of the deficiency to other deficiencies resulting in noncompliance; and 3) the facility's prior history of noncompliance in general, specifically with reference to the cited deficiencies.

DISCUSSION

In reviewing CMS's determinations here, I must answer two questions:

1) Was the facility in substantial compliance with the cited regulatory provision? CMS must present a prima facie case with evidence that, if credible and unrebutted, would constitute proof that the facility was not in substantial compliance. The facility then has the ultimate burden of showing, by a preponderance of the evidence, its substantial compliance with the cited provision. Emerald Oaks, DAB No. 1800, at 4 (2001); Cross Creek Health Care Center, DAB No. 1665 (1998), applying Hillman Rehabilitation Center, DAB No. 1611 (1997), aff'd, Hillman Rehabilitation Center v. HHS, No. 98-3789 (GEB), slip op. at 25 (D.N.J. May 13, 1999); Koester Pavilion, DAB No. 1750, at 7-8 (2000).

2) If I conclude that the facility was not in substantial compliance, I next consider whether the $1,500 PICMP imposed is reasonable, taking into consideration the factors enumerated in 42 C.F.R. � 488.438(f). If I conclude that the facility was not in substantial compliance, I may not review CMS's exercise of discretion in deciding to impose a PICMP; nor may I reduce the PICMP to zero. 42 C.F.R. � 488.438(e).

I make findings of fact and conclusions of law ("Findings") to support my decision in this case. I set forth each Finding, below, in italics, and as a separately numbered heading. I discuss each Finding in detail.

1. Petitioner was not in substantial compliance with the program participation requirement found at 42 C.F.R. � 483.25(h)(2) (Quality of Care).

In order to meet the overall quality of care requirement that it provide what is necessary for each resident to attain or maintain the highest practicable physical, mental, and psychosocial well-being, the facility must ensure that its supervision is adequate to prevent accidents. This requirement does not amount to strict liability or require absolute success in an obviously difficult task. Using an outcome-oriented approach, facilities have the flexibility to use a variety of methods, but they are responsible for achieving the required results. In ensuring adequate supervision, the facility is not required to do the impossible or be a guarantor against unforeseeable occurrence, but it "is required to do everything in its power to prevent accidents." (emphasis added) 42 C.F.R. � 483.25(h); Asbury Center at Johnson City, DAB No. 1815, at 12 (2002); Koester, DAB No. 1750, at 25-26; Woodstock Care Center, DAB No. 1726, at 25 (2000).

Resident #1 was an 88-year-old woman who had severely impaired cognitive skills. CMS Ex. 5, at 3. She required supervision with locomotion "off the unit." According to the facility's interdisciplinary care plan for her, Resident #1 manifested decreased safety awareness secondary to dementia. CMS Ex. 6, at 1. Her care plan described a history of falls and stated that Resident #1 manifested impulsive behavior and wandered. Id. She was unable to ambulate independently, and used a wheelchair for mobility. Id., at 3. Using her wheelchair, she was "able to move thru unit propelling herself." Id., at 1. Another care plan document, dated April 15, 2000, recorded that Resident #1 "wanders in hallways and other residents' rooms (w/c [wheelchair] propelling/wandering)." P. Ex. 8.

Notwithstanding the care plan, Petitioner suggests that Resident #1 did not really venture far, but remained in the hallway outside her own room. Petitioner's Brief (P. Brief) at 3. This seems based entirely on statements from an unidentified staff member who told the surveyor that "the resident was not known to wander around the facility." CMS Ex. 5, at 4. But remaining in the hallway near her own room is not the type of behavior that would merit a care plan. CMS Ex. 6. To the extent that the unattributed statement is inconsistent, I consider the care plan the more reliable evidence. I also conclude that, through the care plan, CMS has met its initial burden of establishing a prima facie case as to Resident #1's history of wandering and need for facility intervention to prevent injury. The facility has failed to overcome that presumption by presenting any reliable documentary evidence or declaration of staff. Indeed, the record as to what was going on with Resident #1 is notably thin. Petitioner submits only one page of progress notes, which are from March 2000, two months before the wandering behavior was identified in the care plan and four months before the accident. The record is therefore silent as to what incidents led to staff identifying the wandering behavior as a problem and addressing it in the care plan. I can, however, reasonably infer that some incident compelled the facility action.

The facility addressed Resident #1's identified problems in her plan of care. To help prevent falls, she was given a low bed, and a bed alarm. CMS Ex. 6, at 2. Petitioner's staff was to use a chair alarm and a soft waist belt when she was out of bed in her wheelchair. Id., at 1-2. Petitioner also planned a number of approaches to address Resident #1's wandering behavior, with the goal of preventing her from injuring herself or others. P. Ex. 8. These included adding Resident #1 to the behavior monitoring list; redirecting her when staff observed her wandering; and "staff/companion walking." P. Ex. 8. ⁽³⁾

On the day of the incident, July 22, 2000, at approximately 9:00 a.m., Debra Neff, a registered nurse employed by Petitioner, redirected Resident #1 from the sub-acute hallway of the facility back to her room. CMS Ex. 7, at 4. The record does not reveal which of the hallways depicted in CMS Ex. 9 is designated for sub-acute care. The next interaction noted between Resident #1 and Petitioner's staff is recorded in the surveyor's notes of an interview with the nursing assistant assigned to care for Resident #1 that morning. The nursing assistant said that, at approximately 11:00 a.m., she gave Resident #1 some cookies in the dining room, and took her to the TV room. P. Ex. 2, at 1; CMS Ex. 5, at 6. Again, the record does not reveal the location of the TV room. The evidence, or absence of evidence, establishes that this assigned care giver had no further contact with Resident #1 that morning. At approximately 11:45 a.m., Nurse Neff reported that she spoke with Resident #1 at the Kingsley nursing station. CMS Ex. 7, at 4. The Kingsley nursing station is adjacent to the hallway where the resident's room was located. CMS Ex. 9.

After 11:45, apparently no one on Petitioner's staff had any idea where Resident #1 was or what she was doing until approximately 12:05 p.m., when a visitor discovered her lying on the concrete outside the facility's front door, having fallen in her wheelchair. CMS Ex. 7, at 2. No one in Petitioner's therapy department saw Resident #1 pass by. ⁽⁴⁾ P. Ex. 2, at 2. The receptionist who was stationed at the front desk had stepped away, apparently to type a patient armband. CMS Ex. 7, at 2.

During the time in question, the front doors of the facility opened automatically via a motion detector. CMS Ex. 5, at 5. While the facility was equipped with an electronic bracelet system to detect resident elopement, Resident #1 was not fitted with a bracelet. P. Brief at 8.

As a result of her fall, Resident #1 sustained a bloody nose, lacerations of the left arm and above the left eye, and an abrasion of her left palm. CMS Ex. 7, at 2, 5. After the accident, Resident #1 was taken to the hospital via ambulance, where she was admitted with a diagnosis of possible intra-cranial bleed. Id., at 2, 6.

Petitioner has chosen to focus on the fact that Resident #1's fall occurred outside the facility in order to characterize the risk to the resident as having been posed by her elopement. The SOD, on the other hand, concludes broadly that Petitioner failed adequately to supervise Resident #1 to prevent her accident. In my view, the question is not so much whether the accident to Resident #1 occurred inside or outside the facility, but whether the supervision provided by Petitioner to Resident #1 was adequate. ⁽⁵⁾ I find that it was not.

When interviewed by one of the State agency surveyors, a member of Petitioner's nursing staff reported that Resident #1 had previously wandered off the unit as far as the therapy room, but had never before wandered as far as the dining room. P. Ex. 2, at 1. In light of Resident #1's unexplained presence in the dining room at 11:00 a.m. that morning, I find it difficult to assess the accuracy or significance of this statement. Perhaps she had not gone that far prior to July 22, but staff certainly knew she was there that morning, well before the time of the incident. The same staff member stated that Resident #1 was unable to open the glass door that led to the courtyard and was generally unable to open doors and pass through. ⁽⁶⁾ Id. Another staff member told the surveyor that the resident had never tried to go out the front door, nor wheeled herself as far as the lobby. Id., at 2.

Petitioner knew that Resident #1 wandered and had developed a plan of care ostensibly aimed at addressing the wandering behavior. It knew that she was at risk for falls; it knew that she was cognitively impaired. If Petitioner had provided adequate supervision to address the risks of which it was aware, then Resident #1 would never have been able to wander out the front door. Petitioner attempts to distinguish between wandering and elopement by pointing out that wandering is movement without apparent rational purpose, while elopement is a willful act involving premeditation. P. Brief at 8 n.2. In either event, however, a facility is required to employ sufficient supervision to prevent residents from exiting the facility, whether they wander away or leave the facility intentionally.

The record before me, while incomplete, suggests that, on the morning of the incident, Resident #1 engaged in wandering behavior on multiple occasions. At 9:00 a.m., one of Petitioner's nurses encountered Resident #1 wandering in a hallway where she apparently did not reside. The nurse redirected Resident #1 to her own room. At 11:00 a.m., Resident #1 was in the dining room where a nursing assistant gave her some cookies and then took her to the TV room. This suggests that Resident #1 had wandered away from her room. By 11:45 a.m., Resident #1 had apparently wandered away from the TV room and back to the Kingsley nurses' station. The nurse recalled that Resident #1 said she was hungry, and that the nurse told her that lunch would be served in half an hour. In contrast to her actions earlier in the morning, the nurse apparently did not redirect Resident #1 to her room or to some other specific location or activity. Instead, it appears Resident #1 wandered off again, perhaps in the direction of the dining room. No member of Petitioner's staff could recall seeing Resident #1 again until she was discovered by a visitor outside the facility at 12:05 p.m.

Petitioner argues that it cannot be expected to provide one-on-one supervision to its residents at all times. P. Brief at 6. It argues that it is not unreasonable for a resident to go unsupervised for a period of 15 to 20 minutes. Id. I agree that a facility is not required to provide constant individual supervision to all its residents. In some cases, a resident might reasonably remain unsupervised for 15 to 20 minutes, or even longer. However, allowing a cognitively impaired resident, who has been identified as at risk for falls, to wander about a facility for 20 minutes without any staff member knowing her activities or whereabouts is neither reasonable nor consistent with the requirement to provide adequate supervision to prevent accidents. Resident #1 might have sustained a fall in any part of the facility while traveling from the nurses' station to the front door; by mischance, she was able to exit the facility and fell outside on the pavement. In Asbury, the Departmental Appeals Board (Board) rejected a facility's similar claim that its primary concern had been "to prevent [its resident] from standing unassisted rather than to prevent her from eloping, which she had never tried to do." In that case, the facility conceded that, at the time of her accident, the resident had been left to wander unsupervised for at least 20 minutes. Based on her identified behaviors, the Board agreed that the facility was not required to provide her with constant supervision, but, based on her plan of care was required to provide supervision while she was wandering. Asbury, DAB No. 1815, at 10.

Nor can the facility even legitimately claim to have checked on Resident #1 every 20 minutes. That a visitor happened upon her was fortuitous, but no evidence shows that the facility had noticed her missing.

Nor has Petitioner demonstrated how it was following Resident #1's care plan. According to the care plan, she was on the "behavior monitoring list." The record does not explain what it means to be on the behavior monitoring list, but presumably this entails some level of supervision and monitoring. That no one was aware of Resident #1's activities for twenty minutes and that her assigned care giver had not seen her for more than an hour does not suggest any meaningful monitoring. According to Petitioner, it followed the care plan because staff "redirected" Resident #1 to other "activities" by putting her in the TV room and by giving her cookies. Whether or not putting someone in a TV room constitutes an activity is subject to debate; however, giving someone a cookie does not constitute providing her an "activity" in any sense of the word. That morning, the few times staff saw Resident #1 where she was not supposed to be, they moved her to another location, but they have not demonstrated that they effectively redirected her.

During a 20-minute interval on the morning and early afternoon of July 22, 2000, no one was monitoring Resident #1; no one was monitoring the corridors; and no one was monitoring the front door. Based on all of this, I conclude that the facility did not do "everything in its power to prevent accidents." It did not ensure that the resident environment was as free of accident hazards as possible, nor that each resident received adequate supervision and assistance devices to prevent accidents, as required by 42 C.F.R. � 483.25(h)(2).

2. The amount of the PICMP imposed against Petitioner, $1,500 for the instance of noncompliance on July 22, 2000, is reasonable.

Having found a basis for imposing a PICMP, I now consider whether the amount imposed is reasonable, applying the four factors listed in 42 C.F.R. � 488.438(f). CarePlex of Silver Spring, DAB No. 1683, at 8 (1999); Capitol Hill Community Rehabilitation and Specialty Care Center, DAB No. 1629 (1997). My "inquiry should be 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." CarePlex, DAB No. 1683, at 8.

CMS imposed a penalty of $1,500, which is just above the $1,000 mandatory minimum and well below the $10,000 maximum for PICMPs. With respect to the factors listed at 42 C.F.R. � 488.438(f), the record is silent as to the facility's financial condition. However, the deficiency was serious: Resident #1 suffered actual harm which resulted in her being admitted to the hospital. Moreover, the facility bears some culpability for Resident #1's accident, due to its lack of supervision over her on July 22, 2000. I conclude that these factors, without more, justify the imposition of a penalty above the minimum, and I find CMS's determination to be reasonable.

The parties disagree as to the impact of the facility's compliance history on the imposition of the PICMP in this case. Petitioner makes much of CMS's apparent reliance on its compliance history, challenging deficiencies cited during an earlier survey, completed March 16, 2000. No remedies were imposed as a result of that March survey, so Petitioner had no opportunity to contest its findings. See P. Brief at 12-18. Petitioner argues that CMS relied on the presence of the deficiencies in March 2000 in making its decision to impose the PICMP at issue here, suggesting that, absent the March 2000 deficiency findings, CMS would not have imposed any remedy at all. Therefore, according to Petitioner, it should now have the opportunity to contest the findings of the earlier survey.

Petitioner's argument fails for a number of reasons. First, I have no authority to review CMS's choice of remedy. 42 C.F.R. � 488.438(e). A facility may not appeal the choice of remedy, including the factors considered by CMS in selecting the remedy. 42 C.F.R. � 488.408(g)(2). So, that CMS decided to impose a CMP is not reviewable, and whether, in deciding to impose a CMP, CMS considered the results of the March survey is not reviewable.

Second, even if I could review the choice of remedy, Petitioner's argument presumes that, but for the March findings, it would have been entitled to an opportunity to correct before any penalty was imposed. Although under certain circumstances CMS might opt to allow a facility an opportunity to correct prior to imposing a remedy, no provision in the statute or regulations entitles a facility to such opportunity. See 59 Fed. Reg. 56,171 (Nov. 10, 1994) (provider is not entitled to an opportunity to correct).

Finally, this is a de novo review. By a long line of cases, the Board has specifically rejected the notion that the ALJ should review CMS' internal process in setting a CMP amount. Emerald Oaks, DAB No. 1800; Community Nursing Home, DAB No. 1807 (2002); CarePlex, DAB No. 1683; see also Barn Hill Care Center, DAB No. 1848 (2002); Capitol Hill Community Rehabilitation and Specialty Care Center, DAB No. 1629; South Valley Health Care Center, DAB No. 1691 (1999). As the Board explained in Emerald Oaks:

[T]he purpose of the hearing here was not to determine whether CMS followed the correct procedure in determining to impose a CMP or setting the amount of the CMP. The hearing at the ALJ level in such cases is intended to determine two fundamental questions: (1) whether a basis existed to support the imposition of the CMP under governing statutory and regulatory authorities, and (2) whether the amount of the CMP fell within a reasonable range based on the applicable law. The ALJ resolves these issues de novo in the sense that the determination is based on the evidence as it is developed before the ALJ and not on how CMS evaluated the evidence as it stood at whatever point CMS made its assessment.

DAB No. 1800, at 13.

So, in reaching a decision on the reasonableness of the CMP, I may not look into CMS's internal decision-making processes. Instead, I consider 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). I am neither bound to defer to CMS's factual assertions, nor free to make a wholly independent choice of remedies without regard for CMS's discretion. Community Nursing Home, DAB No. 1807, at 22, et seq.; CarePlex, DAB No. 1683, at 8.

I have considered the regulatory factors without regard to how CMS may have weighed them. As I have stated above, I conclude that the $1,500 PICMP is minimal and fully justified without regard to Petitioner's history of noncompliance. Accordingly, I find that any evidence concerning Petitioner's compliance or noncompliance at the March 2000 survey is irrelevant to my decision here.

CONCLUSION

For all of the reasons discussed above, I uphold CMS's determination that, on July 22, 2000, the facility was out of compliance with the program participation requirement for Quality of Care. The amount of the PICMP imposed, $1,500 for the single instance of noncompliance, is reasonable.

Carolyn Cozad Hughes

Administrative Law Judge

1. The Health Care Financing Administration has been renamed the Centers for Medicare & Medicaid Services (CMS).

2. Petitioner submitted 20 proposed exhibits (P. Ex. 1 - P. Ex. 20). CMS submitted 9 proposed exhibits (CMS Ex. 1 - CMS Ex. 9). Neither party objected to the exhibits proposed by the opposing party. Therefore, in the absence of objection, I admit into evidence P. Ex. 1 - P. Ex. 20 and CMS Ex. 1 - CMS Ex. 9.

3. Petitioner also moved Resident #1 from room 116 to room 112 due to concerns for the resident's safety. P. Ex. 7. Room 112 is closer to the nurses' station than is room 116. See CMS Ex. 9; see also P. Brief at 9. The record is silent as to the precise safety concern that led to this intervention. However, it appears likely that it was primarily intended to address Resident #1's risk of falls, since she was moved on April 3, 2000, which was before her wandering behavior was noted in the care plan.

4. An examination of CMS Ex. 9 (a floorplan of the facility) shows that someone traveling from the Kingsley nurses' station to the front door could either cross the courtyard or go along a residential corridor (rooms 100 to 111), then down the corridor past the therapy and crafts rooms, through the dining room, and into the lobby.

5. I recognize that the risk of injury is likely greater outside the facility. Whether or not she should have been considered an elopement risk, Resident #1 suffered from dementia and she was a wanderer, and when anyone can exit the facility with relative ease (as she obviously did), this presents an increased danger to unsupervised wanderers which is foreseeable.

6. Since Resident #1 was apparently unable to open the glass doors to the courtyard, and since she was known to have wandered as far as the therapy room on previous occasions, it appears likely that Resident #1 arrived at the front door having traveled through the corridors and not across the courtyard.