SUBJECT:

Greenwood Rehabilitation Center,

Petitioner,

Centers for Medicare & Medicaid Services.

DECISION

I find that, contrary to the allegations of the Centers for Medicare & Medicaid Services (CMS) ⁽¹⁾, Petitioner Greenwood Rehabilitation Center, was in substantial compliance with federal participation requirements relative to 42 C.F.R. � 483.25(h)(2), (Tag F-324), for which it was cited during the September 8, 2000 survey.

I. BACKGROUND

The facts that I recite in this section are not disputed. Petitioner is a long-term care facility located in West Palm Beach, Florida. Many of its residents are individuals who are developmentally disabled and who suffer from mental impairments. On September 8, 2000, surveyors from the Florida Agency for Health Care Administration (AHCA) conducted a follow-up survey to determine if previous citations for non-compliance with Medicare participation requirements had been corrected. The surveyors who conducted that survey found that Petitioner, in several respects, was not complying substantially with federal participation requirements. Most significantly, they found that Petitioner was not complying with some requirements to the extent that residents of Petitioner were placed in immediate jeopardy. During the follow-up survey Petitioner was cited for four non- immediate jeopardy level deficiencies and one deficiency, F-324, which was cited at the immediate jeopardy level.

Petitioner was cited for failing to comply substantially with the following requirements:

1. (F-253) 483.15(h)(2) which alleged that the facility did not provide a safe, clean, comfortable environment.

2. (F-257) 483.15(h)(6) which alleged that the facility did not maintain temperatures that were safe and comfortable in 10 residents' rooms.

3. (F-323) 483.25(h)(1) which alleged that the facility did not maintain an environment free of accident hazards in two of the residents' rooms in the facility.

4. (F-324) 483.25(h)(2) which alleged that the facility did not provide adequate supervision for two residents to prevent potential occurrences of accidents.

5. (F-371) 483.35(h)(2) which alleged that the facility did not ensure the safe, sanitary storage of food and beverages.

In a letter dated September 20, 2000 CMS notified Petitioner that, based on the September 8 survey findings of non-compliance with federal Medicare requirements, it would be imposing a civil money penalty (CMP) in the amount of $4,050 per day effective September 12, 2000, and continuing until the jeopardy was removed. The State survey agency completed a revisit survey on September 29, 2000 and determined that the immediate jeopardy had been removed as of September 24, 2000. By letter dated November 2, 2000, in accordance with section 1128A(c)(2) of the Social Security Act (Act) and 42 C.F.R. �� 488.408(g), 498.40, Petitioner requested a hearing to appeal CMS's finding of non-compliance as outlined in its September 20, 2000 notice letter. Subsequently, the case was assigned to me for hearing and a decision.

I held a hearing on January 15, 2002 in West Palm Beach, Florida. Immediately prior to the hearing, Petitioner conceded to four of the five deficiencies at issue. Accordingly, the only issue before me on appeal, and the only issue litigated by the parties, is (Tag F-324) - 483.25(h)(2), which requires the facility to ensure that each resident receives adequate supervision and assistance devices to prevent accidents.

At the hearing, CMS submitted Exhibits 1, 2, 8, 16, 17, 19, 28, 30, 31, 33, 36, 38, and 43. All of CMS's Exhibits (CMS Ex.), with the exception of CMS Ex. 2, were admitted into evidence. Petitioner submitted Exhibits 1 - 11. Petitioners's Exhibits (P. Ex) 1 - 11 were received and admitted into evidence without objection. After the hearing, the parties submitted their post-hearing briefs. I base my decision on the testimony taken and the evidence presented at hearing, the hearing transcripts, and the parties' post-hearing briefs.

II. ISSUES

The issues in this case are:

1. Whether there is a basis for the imposition of an enforcement remedy; and,

2. If a basis is established, whether the remedy imposed is reasonable.

III. APPLICABLE LAW

The statutory and regulatory requirements for Medicare and Medicaid participation by a long-term care facility are found at sections 1819 and 1919 of the Social Security Act (Act) and at 42 C.F.R. Part 483. Sections 1819 and 1919 of the Act vest the Secretary of Health and Human Services (Secretary) with authority to impose CMPs against a long-term care facility for failure to comply substantially with federal participation requirements.

Pursuant to the Act, the Secretary has delegated to CMS and the states the authority to impose remedies against a long-term care facility that is not complying substantially with federal participation requirements. Facilities that participate in Medicare may be surveyed on behalf of CMS by state survey agencies in order to determine whether the facilities are complying with federal participation requirements. 42 C.F.R. �� 488.10-488.28. The regulations contain special survey conditions for long-term care facilities. 42 C.F.R. �� 488.300-488.335.

Pursuant to 42 C.F.R. Part 488, a state or CMS may impose a per instance or per day CMP against a long-term care facility when a state survey agency concludes that the facility is not complying substantially with federal participation requirements. 42 C.F.R. �� 488.406, 488.408, 488.430. The regulations specify that a CMP that is imposed against a facility on a per day basis will fall into one of two broad ranges of penalties. The upper range of CMP, of from $3,050 per day to $10,000 per day, is reserved for deficiencies that constitute immediate jeopardy to a facility's residents, and in some circumstances, for repeated deficiencies. The lower range of CMP, from $50 per day to $3,000 per day, is reserved for deficiencies that do not constitute immediate jeopardy, but either cause actual harm to residents, or cause no actual harm, but have the potential for causing more than minimal harm. There is only a single range of $1,000 to $10,000 for a per instance CMP. 42 C.F.R. �� 488.408, 488.438.

When a penalty is imposed and appealed, CMS must make a prima facie case that the facility has failed to comply substantially with federal participation requirements. To prevail, a long-term care facility must overcome CMS's showing by a preponderance of the evidence. Batavia Nursing and Convalescent Center, DAB No. 1904 (2004); Batavia Nursing and Convalescent Inn, DAB No. 1911 (2004); Emerald Oaks, DAB No. 1800 (2001); Cross Creek Health Care Center, DAB No. 1665 (1998); Hillman Rehabilitation Center, DAB No. 1611 (1997), aff'd Hillman Rehabilitation Center v. U.S. Dept. of Health and Human Services, No. 98-3789 (D.N.J. May 13, 1999).

The Act and regulations make a hearing before an administrative law judge (ALJ) available to a long-term facility against which CMS has determined to impose a CMP. Act, section 1128A(c)(2); 42 C.F.R. �� 488.408(g), 498.3(b)(12), (13). The hearing before an ALJ is a de novo proceeding. Anesthesiologists Affiliated, et al, DAB CR65 (1990), aff'd, 941 F2d. 678 (8^th Cir. 1991). A facility has a right to appeal a "certification of noncompliance leading to an enforcement remedy." 42 C.F.R. � 488.408(g)(1); see also 42 C.F.R. �� 488.330(e) and 498.3. However, the choice of remedies by CMS or the factors CMS considered when choosing remedies are not subject to review. 42 C.F.R. � 488.408(g)(2). A facility may only challenge the scope and severity level of noncompliance found by CMS if a successful challenge would affect the amount of the CMP that could be collected by CMS or impact upon the facility's nurse aide training program. 42 C.F.R. �� 498.3(b)(14) and (d)(10)(i). CMS's determination as to the level of noncompliance "must be upheld unless it is clearly erroneous." 42 C.F.R. � 498.60(c)(2). This includes CMS's finding of immediate jeopardy. Woodstock Care Center, DAB No. 1726, at 9, 38 (2000), aff'd Woodstock Care Center v. U.S. Dept. of Health and Human Services, 2004 FED App. 0095P (6^th Cir.).

IV. ANALYSIS

CMS argued at the hearing and in its post-hearing brief that, beginning September 8, 2002, and continuing through September 24, 2002, Petitioner failed to provide adequate supervision for two of its residents, thus violating 42 C.F.R. � 483.25(h)(2) which requires the facility to ensure that each resident receives adequate supervision and assistance devices to prevent accidents. CMS argues that the failure by Petitioner to provide adequate supervision placed two residents in immediate jeopardy.

The events in question concern two residents in Petitioner's facility - Resident 4 (R4) and Resident 6 (R6). In the first instance, state surveyor James Johnson observed R4 standing in front of a window in an unoccupied room allegedly attempting to elope from the facility through the window. R4 was redirected to his room and about two hours later R4 was again observed by surveyors coming out of the same unoccupied room where he had previously been found. During that same survey another resident, R6, was observed, by surveyors James Johnson and Briana Harquist, seated in a wheelchair alone in her room with the cord from a call bell looped twice around her neck.

Based on these observations, the surveyors alleged that Petitioner failed to comply with the requirements of 42 C.F.R. � 483.25(h)(2). CMS Ex. 2, at 8 - 16. The regulation requires that a facility ensure that "(e)ach resident receives adequate supervision and assistance devices to prevent accidents." 42 C.F.R. � 483.25(h)(2). This alleged deficiency was cited at F-Tag 324 and falls within the area of quality of care.

The specific manner by which facilities are to deliver care and services is not prescribed by the regulations. Rather, a facility is permitted to determine the means to achieve the regulatory ends. In the case of 42 C.F.R. � 483.25(h)(2), the regulatory end is the prevention of accidental injury of nursing facility residents. The issue, in this instance, is whether the quality of the supervision, or lack thereof, at Petitioner's facility was such that residents were subject to the risk of injury from accidental causes in their daily activities.

A. Resident 4

The Statement of Deficiencies, HCFA-2567-L, (2567), indicated that "On 9/8/00 while touring the facility with LPN, the surveyors . . . found an unattended resident (Resident 4) opening a window while pushing his/her hand against the window screen." CMS Ex. 33, at 7. "At approximately 2:15 PM, while touring this same area with another surveyor, this same resident was observed coming out of [the same room] alone. The room was entered again and the window was open to its maximum." Id. The room was on the third floor of the facility. Transcript (Tr.) at 56. Based on these facts, the surveyors alleged that Petitioner failed to provide the supervision necessary to prevent the potential elopement of R4. At trial, CMS maintained that it was foreseeable that R4 could have fallen from the third floor window suffering death or serious injury, had he not been noticed in the unoccupied room. Tr. at 56 - 57. Surveyor Johnson testified that he believed that the space between the slats in the louvered window was wide enough so that a human being could possibly go out between them. Id. CMS did not present actual measurements of the space between the louvered slats or photographs of the window in issue to prove this assertion.

R4's assessment indicated a "potential risk of harm to self and others related to unawareness to safety due to impaired cognition and communication skills; wanders from room to room, not easily redirected." CMS Ex. 16, at 38. R4's care plan, in relevant part, prescribed that he be monitored for mental changes and such changes should be reported to his physician. The care plan also called for monitoring of wandering and that R4 was to be redirected as needed.

Petitioner argued that R4 had no prior history of elopement or incidents of harm to himself or others. Petitioner further argued that the nurses at the facility routinely monitored him in the hallways and checked him for incontinence every two hours. P. Ex. 10 at 37; Tr. at 183. Petitioner argued that, based on R4's history and lack of previous elopement attempts or incidents where he attempted to harm himself or someone else, the supervision provided by Petitioner was adequate. CMS's post-hearing Brief (CMS Br.) at 5. Petitioner provided the testimony of Ms. Irene Streever, Director of Nursing at the facility, who testified that, based on R4's prior history, there was no need to develop a care plan for dangerous behavior towards himself. Tr. at 175. Ms. Streever testified that there was no known risk for R4 to be alone in his room or alone in anyone else's room. Tr. at 178. She also testified that the fact that R4 was in an unoccupied room with a window open and his hand on the screen would not lead her to conclude that he was attempting to harm himself. Id. She also testified that, based upon her training, education, experience and review of the record of R4, that she did not believe that R4 was attempting to harm himself when he was seen leaving the unoccupied room the second time he was observed by the surveyors. Ms. Streever also testified that, during her employment at the facility, no resident had attempted to elope through any of the louvered windows. Tr. at 178. I found Ms. Streever's testimony to be responsive and credible.

Ms. Natalie Peterson, a nursing home administrator and Director of Operational Development with Evergreen Health Care, the company which managed Petitioner's facility, provided testimony relative to the design and structure of the window through which R4 was alleged to have attempted to elope.

The window screen was attached by four screen locks on the interior of the window, the entire window was incased by steel-metal and then each window pane was also incased by metal. Thus, there was no exposed glass. The window had louvers, which even in the fully open position were too small to fit through, and even the best efforts of the staff failed to break the integrity of the screens covering the window, thus thwarting any possible escape through the window.

P. Ex. 8 - 9; Tr. at 147 - 152.

Ms. Peterson also testified that she measured the space between the slats in the louvered window of the room in issue and found the lowest opening in the stats was 10 � inches and the top three slats had 14 � inch wide spaces between them. Tr. at 165; P. Ex. 11.

While CMS argued that the supervision of R4 was inadequate, CMS offered no evidence as to the lack of supervision or evidence to demonstrate what type of supervision and documentation would have been appropriate in R4's case. Furthermore, CMS did not present any evidence to demonstrate what type of documentation or monitoring was appropriate to establish the monitoring of R4 under his care plan. In addition, CMS's contention that R4 attempting to push out the screen of the window in the unoccupied room, squeeze through the louvered window slats, and elope is nothing more than speculation. CMS's evidence seems inconsistent. CMS first states that R4 was sitting alone in an empty room the first time he was found in the unoccupied room by surveyor Johnson. The very next sentence indicates that R4 was standing against the window, which was open, and he was pushing on the screen covering the louvered window. CMS Br. at 10. Thus, it is unclear what R4 was actually doing in the room when he was first observed by surveyor Johnson.

CMS argued that R4 could very well have exited the facility via the third floor window, unnoticed by facility staff. Id. However, there is no evidence that R4 attempted to remove the screen from the window or attempted to exit through the slats on the louvered window on September 8, 2000 or at any other time during his stay at Petitioner's facility. I find most interesting the fact that "all the windows in the facility had the same physical characteristics, thus the resident would be exposed to the identical 'danger' alone in his own room or any other room in the facility." Petitioner's post-hearing Brief (P. Br.) at 5. The second time R4 was found in the room the surveyors saw him leaving the unoccupied room. Tr. at 61 - 62. CMS presented no evidence to establish that the fact that R4 may have been alone in the unoccupied room placed R4 at risk for potential harm, injury, or death.

I found the testimony of Petitioner's witnesses relative to the care of R4 to be credible and convincing. I am persuaded that the history of R4's lack of elopement attempts or incidences of attempted harm to himself or others, bolsters Petitioner's argument that the supervision provided to R4 was adequate. Even if I found that R4 was not adequately supervised on September 8, the evidence does not establish that it was foreseeable that R4 was trying to elope through the third floor window. Furthermore, the testimony and measurements obtained by Petitioner relative to the structure and dimensions of the window and screen establish by a preponderance of the evidence that it would be physically impossible for R4 to remove the screen from the window, squeeze through the louvered slats, and elope. Thus, I do not sustain the surveyors' conclusion that this situation presented immediate jeopardy to R4. Accordingly, I conclude that Petitioner has established that it provided adequate supervision of R4 as required by the resident's care plan. I further find that the evidence does not establish that R4 was trying to elope through the third floor window and that Petitioner's alleged actions or inaction in this case did not have the potential to have caused serious injury, harm, impairment, or death to the resident.

B. Resident 6

"While touring the facility on 9/8/00, at 1:00 PM, resident #6 was found in room 208 sitting in a wheelchair next to the bed with a call bell wrapped two (2) times around the residents neck." CMS Ex. 33, at 6. "When the resident was asked by the surveyor why the cord was around her neck, the resident did not respond." Id.

R6's care plan indicated that she wandered and prescribed that she be redirected and receive assistance as needed, when she is found wandering. Her care plan also indicated that she needed supervision to prevent falls. CMS Ex. 33. CMS argued that "clearly resident 6 was not being adequately supervised, as she was sitting alone in her room with a call bell cord precariously wrapped around her neck, for an uncertain period of time." CMS Br. at 6. However, R6's care plan does not indicate that R6 required supervision while she was in her room, seated in a wheelchair.

Ms. Streever testified that R6 had not attempted to harm herself in the past during her time at Petitioner's facility. Therefore, Ms. Streever confirmed, there was no reason to develop a care plan to address the risk that R6 would engage in dangerous behavior. Tr. at 168.

It is unclear from witness' testimony how tight the cord was around the resident's neck. Petitioner argued that no matter how the cord was affixed, there is virtually no possibility that the resident could have been successful in choking herself with it. P. Br. at 6. Ms. Natalie Peterson testified for Petitioner relative to this issue as well. She testified that she and other operations staff from the facility tested this specific call bell and that it pulled away from the wall as it was designed to do. Tr. at 143. State surveyor Johnson also testified that the cord would pull away from the wall as it was designed to do. However, he speculated that it could get caught in the wheelchair, the night stand, or the bed if R6 were to fall over. He did not testify that such an event ever happened or was likely to happen, but it could be a possibility.

I believe that the surveyor's speculation is outweighed by the fact that the cord was tested several times by several individuals and each time the cord was tested it pulled away from the wall as it was designed to do. Mr. Johnson's own testimony confirms that fact as well. Furthermore, while CMS argues that R6 was not adequately supervised, there was no requirement in R6's care plan that R6 had to be supervised while she was in her room or in a wheelchair. Moreover, R6's prior history at the facility would not place Petitioner on notice that R6 would wrap a call bell cord around her neck. CMS did not allege that Petitioner did not comply with R6's care plan nor was there evidence or testimony by CMS establishing what type of supervision would have been appropriate in R6's case to prevent her from wrapping the call bell cord around her neck.

In citing a violation of Tag F-324, the surveyors alleged that Petitioner failed to comply with the requirements of 42 C.F.R. � 483.25(h)(2). CMS Ex. 2, at 8 - 16. The regulation requires a facility to ensure that each of its residents receives adequate supervision and assistance devices to prevent accidents. Allegedly, Petitioner failed to provide necessary supervision to two of its residents to prevent incidents and accidents from occurring in Petitioner's facility. Id. at 8. The surveyors - and ultimately, CMS - found that this failure to provide supervision placed the residents in immediate jeopardy because it created a likelihood that the residents would suffer harm, serious injury, or death.

In order to evaluate a facility's compliance with 42 C.F.R. � 483.25(h), it is necessary to examine whether the facility did all it could to "prevent foreseeable accidents" or whether the facility did "everything in its power to prevent accidents." Odd Fellow and Rebekah Health Care Facility, DAB No. 1839, at 6 - 7 (2002), quoting Asbury Care Center at Johnson City, DAB No. 1815, at 12 (2002) and Koester Pavilion, DAB No. 1750, at 25 -26 (2000). Section 483.25(h)(2) requires that a facility provide both "assistive devices" and "adequate supervision" to prevent accidents. What supervision or assistive devices are adequate depends on what kind of measures would be calculated to prevent potential accidents from occurring, given the known or reasonably foreseeable risks. In Woodstock Care Center, the Board considered whether the facility had notice of or should reasonably have anticipated the risk of the kind of events that occurred and whether any reasonable means were available to prevent them without violating the residents' rights. DAB No. 1726, at 26-27.

Implicit in 42 C.F.R. � 483.25(h)(2) is a rule of reason. The regulation obligates a facility to take necessary measures to deal with hazards that are reasonably foreseeable. A facility is not liable per se for every accident that occurs on its premises nor is it charged with liability for hazards that a reasonable person would not foresee. What was reasonably foreseeable here? I do not believe that Petitioner could have foreseen that R6 would wrap a bell cord around her neck. Petitioner convincingly argued that this was an isolated incident and nothing in R6's past history at the facility would place Petitioner on notice that such conduct was likely to occur.

As previously noted, Irene Streever convincingly testified that, given the history of R4 and R6, and their respective care plans, the two were adequately supervised. Petitioner argued generally that CMS has not made a prima facie showing with respect to this deficiency. Petitioner argued that it did everything it reasonably should to supervise bot R4 and R6. I agree. Thus, based on my review of all of the testimony, evidence, and arguments submitted by the parties, I find that Petitioner was in substantial compliance with federal participation requirements relative to 42 C.F.R. � 483.25(h)(2), Tag F-324, during the September 8, 2000 survey. Therefore, CMS's finding of immediate jeopardy cannot be sustained.

Because the finding of immediate jeopardy is not sustained, a CMP in the upper range is per se unreasonable. The parties did not offer evidence as to what would be a reasonable CMP (if any) for the tags to which Petitioner conceded in the event I were to conclude that there was no immediate jeopardy. Therefore, I have no basis on which to issue any finding as to a new CMP amount. In the event CMS determines on the basis of the deficiencies which Petitioner has conceded that a CMP is still justified, albeit in the lower range of CMPs, CMS should issue a new notice of imposition of remedies stating a new CMP amount. Petitioner will then have the option to pay the new amount or request review of that determination. In the event Petitioner were to request review, the only issue would be whether the new CMP amount is reasonable

V. CONCLUSION

Based on the testimony offered at the hearing, the documentary evidence, the arguments of the parties, and the applicable law and regulations, I find that from September 8, 2000 through September 24, 2000, Petitioner was in substantial compliance with Medicare participation requirements relative to 42 C.F.R. � 483.25(h)(2), Tag F-324, for which it was cited at the immediate jeopardy level during the September 8, 2000, survey. Therefore there is no basis for the imposition of an enforcement remedy relative to the immediate jeopardy citation.

Alfonso J. Montano

Administrative Law Judge

1. The Health Care Financing Administration (HCFA) has been renamed the Centers for Medicare and Medicaid Services. Reference to either name shall apply to the same entity, CMS.