SUBJECT:

Pataskala Oaks Care Center,

Petitioner,

Centers for Medicare & Medicaid Services.

DECISION

Petitioner, Pataskala Oaks Care Center (Petitioner or facility), is a long term care facility certified to participate in the Medicare and Medicaid programs as a provider of services. Petitioner challenges the Centers for Medicare & Medicaid Services' (CMS's) determination that, from May 18, 2001 through May 31, 2001, it was not in substantial compliance with program participation requirements. Petitioner does not otherwise challenge the penalties CMS has imposed. Request for Hearing, CMS Exhibit (Ex.) 18. For the reasons set forth below, I find that this case presents no genuine issue of material fact requiring an in-person hearing, and that the facility was not in substantial compliance with program participation requirements during the period in question.

I. Background

Responding to an anonymous complaint, surveyors from the Ohio Department of Health (State Agency) completed a complaint investigation (abbreviated survey) on May 18, 2001. CMS Exs. 1; 21, at 1 � 3. Based on their findings, the State Agency concluded that the facility was not in substantial compliance with federal requirements for nursing homes participating in the Medicare and Medicaid programs. Specifically, it found that the facility did not meet federal requirements under 42 C.F.R. � 483.25(h)(2) (Tag F-324 - Quality of Care) at a "G" level of scope and severity (isolated instance of actual harm).

CMS agreed with the State Agency, and so advised the facility in a letter dated June 15, 2001. CMS Ex. 11. CMS imposed a CMP of $500 per day, effective May 18, 2001, along with other remedies: denial of payment for new Medicare and Medicaid admissions; eventual termination of Petitioner's participation agreement; and the loss of Petitioner's nurse aide training and/or competency evaluation program (NATCEP). Thereafter, the State Agency completed a follow-up survey on July 19, 2001, and determined that Petitioner was back in compliance as of June 1, 2001. By letter dated September 21, 2001, CMS advised the facility that the $500 per day CMP was discontinued effective May 31, 2001, resulting in a $7,000 CMP ($500 per day for 14 days, from May 18 through 31, 2001), and that it was rescinding the other remedies proposed. CMS Ex. 14.

Petitioner timely appealed, and the case was assigned to me. The parties submitted pre-hearing briefs and proposed exhibits (CMS Exs. 1-36 and Petitioner's exhibits (P. Exs.) 1-22). CMS's Pre-Hearing Brief (CMS Brief); Petitioner, Pataskala Oaks Care Center's Pre-Hearing Brief (P. Brief). CMS subsequently moved for summary judgment. CMS's Motion for Summary Judgment and Memorandum of Law in Support (CMS MSJ Brief). Petitioner responded with its brief in opposition to the motion. Petitioner's Memorandum Contra Respondent's Motion for Summary Judgment (P. MSJ Response). CMS asked that I consider all the exhibits offered in deciding its motion for summary judgment, both its own and Petitioner's proposed exhibits, and Petitioner did not object to the admission of the exhibits offered. In the absence of any objections, and, for purposes of this summary judgment ruling, I admit CMS Exs. 1-36 and P. Exs. 1-22.

While this matter was pending, the Sixth Circuit Court of Appeals issued its decision in Crestview Parke Care Center v. Thompson, 373 F.3d 743 (6^th Cir. 2004), and I invited the parties to comment on that decision's impact, if any, on the issues in this case. Each party then filed a supplemental brief. Respondent's Supplemental Memorandum of Law in Support of its Motion for Summary Judgment (CMS Supp. Brief); Petitioner, Pataskala Oaks Care Center's Brief in Response to the Crestview Parke Decision (P. Supp. Response). I have considered the arguments presented in those submissions. ⁽¹⁾

II. Issues

I consider first whether summary judgment is appropriate.

On the merits, I must determine whether, from May 18 through May 31, 2001, the facility was in substantial compliance with program participation requirements.

III. Statutory and Regulatory Background

The Social Security Act sets forth requirements for nursing facility participation in the Medicare and Medicaid programs, and authorizes the Secretary of Health and Human Services (Secretary) to promulgate regulations implementing the statutory provisions. Act, sections 1819 and 1919. The Secretary's regulations governing nursing facility participation in the Medicare program are found at 42 C.F.R. Part 483.

To participate in the Medicare and Medicaid programs, facilities periodically undergo surveys to determine whether they comply with applicable statutory and regulatory requirements for Medicare (SNFs) and/or Medicaid (NFs). They must maintain substantial compliance with program requirements and, 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 statute and "quality of care" regulation, each resident must receive and the facility must provide the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the resident's comprehensive assessment and plan of care. Act, section 1819(b); 42 C.F.R. � 483.25. Specifically, the facility must ensure that each resident receives adequate supervision and assistance devices to prevent accidents. 42 C.F.R. � 483.25(h)(2). An "accident" is "an unexpected, unintended event that can cause a resident bodily injury," excluding "adverse outcomes associated as a direct consequence of treatment or care (e.g., drug side effects or reactions)." State Operations Manual (SOM) Appendix PP, Guidance to Surveyors for Long Term Care Facilities, Part 2, SOP 483.25 Quality of Care (Rev. 274, June 1995) (SOM Guidance), ⁽²⁾ see Woodstock Care Center, DAB No. 1726, at 4 (2000), aff'd, Woodstock Care Center v. Thompson, No. 01-3889 (6^th Cir. Nov. 17, 2003) (unpublished).

IV. Discussion

A. Summary disposition is appropriate because this case presents no dispute over genuine issues of material fact. ⁽³⁾

An administrative law judge (ALJ) may decide a case on summary judgment, without an evidentiary hearing, if the case presents no genuine issue of material fact. Crestview Parke Care Center, 373 F.3d at 750; Livingston Care Center, No. 03-3489, 2004 WL 1922168, at 3. By interpretive rule, this tribunal has established a summary judgment procedure "akin to the summary judgment standard contained in Federal Rule of Civil Procedure 56." Crestview Parke Care Center, 373 F.3d at 750. Under that rule, the moving party may show the absence of a genuine factual dispute by presenting evidence so one-sided that it must prevail as a matter of law, or by showing that the non-moving party has presented no evidence "sufficient to establish the existence of an element essential to that party's case, and on which that party will bear the burden of proof at trial." Livingston Care Center, No. 03-3489, 2004 WL 1922168, at 4, citing Celotex Corp. v. Catrett, 477 U.S. 317, 322 (1986). The nonmoving party must then act affirmatively by tendering evidence of specific facts showing that a dispute exists. Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 586 n.11 (1986). See also Vandalia Park, DAB No. 1939 (2004); Lebanon Nursing and Rehabilitation Center, DAB No. 1918 (2004). A mere scintilla of supporting evidence is not sufficient. "If the evidence is merely colorable or is not significantly probative summary judgment may be granted." Livingston Care Center, No. 03-3489, 2004 WL 1922168, at 4, quoting Anderson v. Liberty Lobby, 477 U.S. 242, at 249-250 (1986).

To establish that summary judgment is appropriate here, CMS points to a limited set of facts, which Petitioner has not disputed: Resident 18 (R18) was admitted to the facility in March 1999. At the time of the survey, she was 85 years old, with diagnoses including Alzheimer's Disease and osteoporosis (bone thinning). P. Ex. 1, at 1, 5; CMS Ex. 23, at 10; CMS Ex. 25, at 6; CMS Ex. 28, at 1-2. By September 27, 2000, the facility had identified her as at risk for injury due to falls because of her decline in cognitive status, use of psychotropic medication, and poor safety awareness. P. Ex. 2, at 7; CMS Ex. 27, at 7. In January 2001, she was still walking on her own, but facility staff noticed that she walked with a forward-leaning gait, which significantly increased her risk for falls. P. Exs. 3, 6; CMS Ex. 23, at 5. The facility determined that she could no longer walk independently and safely, so, on January 15, 2001, her physician ordered that a tabs alarm unit be attached to her bed and to any chair she sat in. Her physician also ordered a back release seat belt applied to her wheelchair so that she could move safely about the facility via the wheelchair, without risk that she would attempt to walk unaided. P. Ex. 4, at 2, 3; P. Ex. 5; P. Ex. 6 �� 5, 6; P. Ex. 11, at 7; CMS Ex. 15, at 3; CMS Ex. 29, at 1. On about February 5, R18 demonstrated that she was able to disconnect her bed alarm, so the facility discontinued its use. CMS Ex. 15, at 2. Staff later lowered her bed. However, R18 was still able to get out of bed and walk around the halls, unaided, which she did, at least occasionally, generally late at night or early in the morning. CMS Ex. 30, at 2.

On the night of April 9, 2001, staff observed R18 out of her room, out of her wheelchair, walking down the hall by herself. P. Ex. 11, at 12; CMS Ex. 23, at 5. She ended up on the floor. An x-ray taken the following day showed that she had a hip fracture. P. Exs. 14, 15; CMS Ex. 34. See also P. Brief at 3-5; CMS MSJ Brief at 2-7.

CMS also points to facts that Petitioner has not disputed regarding care provided to Resident 61 (R61): R61 was 81 years old at the time of the survey, with diagnoses of congestive heart failure, arthritis, osteoporosis, depression, dementia, and Parkinson's disease. CMS Ex. 24, at 4; P. Ex. 22. The facility assessed her as at high risk for falls, and, to prevent them, her care plan required (and her physician ordered) that she have a front release seat belt on her wheelchair and chair alarms in place whenever she was in her wheelchair or recliner. See P. Brief at 5; CMS Ex. 21, at 3 � 9. Nevertheless, on three or four occasions, the surveyors observed R61 sitting in her wheelchair or recliner without the alarm in place. CMS Ex. 19, at 7-8; CMS Ex. 21, at 3-4; CMS Ex. 23, at 8; CMS Ex. 24, at 4-6.

In examining the evidence for purposes of determining the appropriateness of summary judgment, I must draw all reasonable inferences in the light most favorable to the non-moving party. Livingston Care Center, No. 03-3489, 2004 WL 1922168; Guardian Health Care Center, DAB No. 1943, at 8 (2004). Some confusion seems to have arisen about the differences between drawing factual inferences in the light most favorable to the nonmoving party, on the one hand, and reaching legal conclusions based on the undisputed facts (which facts incorporate the inferences drawn in favor of the nonmoving party), on the other. Drawing factual inferences in the light most favorable to the nonmoving party does not require that I accept the nonmoving party's legal conclusions. Cf. Guardian Health Care Center, DAB No. 1942, at 11 ("A dispute over the conclusion to be drawn from applying relevant legal criteria to undisputed facts does not preclude summary judgment if the record is sufficiently developed and there is only one reasonable conclusion that can be drawn from those facts.")

In this case, the parties agree that R18 was walking down the hallway by herself, and she ended up lying on the floor. Although CMS has argued that the more reasonable inference is that R1 fell, the agency concedes that, in deciding this motion, I must draw a factual inference in the light most favorable to the facility, and conclude that R18 sat and then lay down on the floor. Moreover, the facility provides evidence that staff observed R18 sit and then lie down in the middle of the hall. P. Ex. 11, at 12. CMS, however, points to facility records that characterize the incident as a "fall." CMS Ex. 26, at 6; CMS Ex. 35, at 3; CMS Ex. 29, at 15. Whether I consider this a dispute of fact or disagreement as to the inference drawn from undisputed facts, I resolve the disagreement in the facility's favor, and conclude that R18 was walking unassisted when she sat, and then lay down, in the hallway.

The parties also agree that the following day R18 was diagnosed with a broken hip. CMS attributes the injury to her fall. CMS Pre-Hearing Brief at 3, 7. The facility disagrees, attributing the injury to some other cause, such as her significant osteoporosis. Again, I draw an inference in the light most favorable to the nonmoving party, and decline to attribute R18's broken hip to her sitting down on the hallway floor the day before.

The parties also agree that R61 had a physician's order for a chair alarm, and that the alarm was not in place on several occasions during the course of the survey. P. MSJ Response at 3, 11. Petitioner justifies this by claiming that, on some of these occasions, she was otherwise under staff supervision, and, when not supervised, she had a lap belt in place. For purposes of this motion, I accept as true Petitioner's factual claims.

The legal question presented is whether, based on these undisputed facts and the inferences I have drawn from them, the facility was in substantial compliance with the quality of care regulation, 42 C.F.R. � 483.25(h)(2). I next address that question.

B. From May 18 through May 31, 2001, the facility was not in substantial compliance with the program participation requirement set forth at 42 C.F.R. � 483.25(h)(2).

The quality of care regulation, 42 C.F.R. � 483.25, imposes on facilities an affirmative duty designed to achieve favorable outcomes "to the highest practicable degree." Windsor Health Care Center, DAB No. 1902, at 16-17 (2003); Woodstock Care Center, DAB No. 1726, at 25-30. In ensuring adequate supervision, the facility is not required to do the impossible or be a guarantor against an unforeseeable occurrence, but it is required 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." 42 C.F.R. � 483.25(h)(2); Windsor Health Care Center, DAB No. 1902, at 5; Asbury Center at Johnson City, DAB No. 1815, at 12 (2002); Woodstock Care Center, DAB No. 1726, at 25. The regulation requires the facility to anticipate what accidents might befall a resident and to take steps - increased supervision or the use of assistance devices - to prevent them. Guardian Health Care Center, DAB No. 1943, at 18.

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.

Windsor Health Care Center, DAB No. 1902, at 5. Measures taken by the facility to prevent accidents must be considered in deciding whether the facility satisfies the regulatory requirement that each resident receive adequate supervision and assistance devices. Guardian Health Care Center, DAB No. 1943, at 12.

In determining whether measures are "adequate" for a particular resident, I consider the resident's functional capacity, behavioral patterns or tendencies, and other relevant factors. Rosewood Care Center of Edwardsville, DAB No. 1898, at 8 (2003). Where, as here, the parties do not dispute its contents, review of a resident's comprehensive assessment is a good starting place for determining that "functional capacity, behavioral patterns or tendencies, and other relevant factors." Id. at 8-9.

R18: That the facility had long identified R18 as at risk for injury due to falls is well-documented in her care plan. See, e.g., CMS Ex. 27, at 7; P. Ex. 2, at 7. Nevertheless, up until about December 2000/January 2001, she appears to have been able to walk independently. P. Ex. 6, at 1 � 4 (Isbister Decl.). By January, however, facility staff recognized that she was no longer able to walk independently in a safe manner, and it began to take steps to minimize her risk of injury. P. Ex. 11, at 6 (R18 has "become unsteady" and "slumps over herself and appears to trip on carpet."). Among other interventions, she was referred to physical therapy for evaluation of her unsteady gait and general weakness. P. Ex. 11, at 7. The facility experimented with seatbelt restraints, finally settling on a more restrictive back release seatbelt, after other interventions proved ineffective. P. Ex. 3; P. Ex. 6, at 1 �� 5-7; CMS Ex. 31, at 1-3. According to the facility administrator, Kathy Isbister, after the facility provided the wheelchair with back release belt, R18 often safely propelled herself around the facility. Administrator Isbister cites eight specific instances in which R18 did so, all occurring in the afternoon or early evening hours, none later than 6:00 p.m. P. Ex. 6. Administrator Isbister opines that "with the implementation of the use of the wheelchair . . . the proper and least restrictive devices were being used for the resident." Id. at 2 � 12. I do not disagree. By all accounts, R18 was able to move safely about the facility so long as she was restrained in a wheelchair. During the day, staff restrained her in her wheelchair. However, the facility was not implementing this intervention on the night of April 9, nor on other nights, and the steps the facility took to prevent her late night wandering fell short of adequate to prevent an accident.

Administrator Isbister asserts, generally, that it "appeared that [R18's] nighttime wandering was significantly reduced," (P. Ex. 6, at 2 � 8) ⁽⁴⁾ but she does not claim that the nighttime wandering stopped. ⁽⁵⁾ Indeed, on February 5, 2001, R18 was again found out of bed and wandering the halls. The facility surmised that she had learned to deactivate her bed alarm, and responded by discontinuing it. CMS Ex. 15, at 2; CMS Ex. 19, at 4 � 10. On February 27, the facility lowered her bed and put pads on the sides in an effort to discourage the nighttime wandering, but that intervention did not stop her from getting out of her bed and walking, and, at 5:40 a.m. on February 28, 2001, she was again "ambulating in the hallway." P. Ex. 11, at 9; P. Ex. 7 � 3 (Idress Decl.); P. Ex. 8 � 7 (Abbott Decl.); CMS Ex. 29, at 3.; CMS Ex. 32, at 1. On March 14, 2001, she "ambulated into hallway from [room], awake, restless, wouldn't go back to bed." CMS Ex. 30, at 2. ⁽⁶⁾

On April 9, 2001, R18 was again walking alone down the hall. She apparently sat herself down on the floor, without assistance, and then lay down. P. Ex. 11, at 12; CMS Ex. 33, at 1, 3. I consider this dangerous behavior. Immediately thereafter, she denied problems or pain, and staff returned her to bed. P. Ex. 11, at 13. The following day, staff noted that she was not weight bearing on her right side, and did not transfer in her usual manner. She did not complain of pain until that afternoon. A right hip x-ray showed a fracture of the right femoral head. Id.; CMS Ex. 33, at 1-3.

I need not find that R18 fell nor that she suffered actual harm as a result of this incident. The potential for more than minimal harm is sufficient to establish substantial noncompliance. 42 C.F.R. � 488.301. I agree with CMS that a resident, like R18, with osteoporosis, unsteady gait, poor safety awareness, psychotropic drug usage, Alzheimer's, and impaired vision could not safely walk through the halls unassisted and could not safely seat herself on the floor. That she was able to do so without facility intervention created the potential for more than minimal harm, without considering whether it directly resulted in her fractured hip.

Petitioner argues that the April 9 event was unforeseeable because, even if that event were considered a fall, R18 had not fallen before. Had the facility no reason to suspect R18's vulnerability, its position might have merit. A facility is not accountable for "untoward events that could not reasonably have been foreseen and forestalled." Guardian Health Care Center, DAB No. 1943, at 18, quoting Tri-County Extended Care Center, DAB No. 1936 (2002). However, I do not agree that a history of falls is a necessary prerequisite to the facility's "taking reasonable steps" to prevent falls, where the facility has itself recognized the risk. The facility is simply not entitled to one "free fall" before it takes appropriate actions to prevent accidents. See Ridge Terrace, DAB No. 1834, at 6 (2002). ("[E]ven one isolated instance of noncompliance having a potential for more than minimal harm may be the basis for a finding that the petitioner is not substantially complying with the applicable participation requirement.") Here, the facility obviously recognized the risk, and took some reasonable steps that likely decreased R18's risk, at least during the day and early evening hours. However, during the night and early morning hours, R18 engaged in a behavior that the facility knew was unsafe, and, for this nighttime wandering, Petitioner did not follow a process comparable to the one it followed in addressing R18's daytime wandering. When the bed alarms were discontinued, and the lowered mattress proved ineffective, the facility had a duty to try other interventions, which it failed to do here. ⁽⁷⁾

Petitioner also suggests that it did not take additional actions to prevent the risks posed by R18's nighttime wandering because of its concern for her rights to be free of restraints and to move freely about the facility. While allowing residents as much freedom as possible is a commendable goal (and required by the regulations), that does not relieve the facility of its duty to protect its residents. Asbury Center at Johnson City, DAB CR807, at 11, aff'd DAB No. 1815, and aff'd Asbury Center at Johnson City v. Dep't. of Health & Human Services, No. 02-3438, 2003 WL 22290204 (6th Cir. October 2, 2003) (unpublished). Even though R18 would not cooperate with the use of the bed alarm, when the lowered mattress proved ineffective, the facility was not free to end its efforts to protect her from her recognized dangerous behavior.

Petitioner compares its own situation to that of the facility in Koester Pavilion, DAB CR650 (2000), where ALJ Clifton found a facility in substantial compliance with the quality of care regulation. However, Petitioner does not recognize that, on appeal, Koester Pavilion was reversed in part. Koester Pavilion, DAB No. 1750, at 30-31 (2000). The Departmental Appeals Board affirmed ALJ Clifton's conclusion that one resident's being lowered to the floor by an aide during a short walk to the bathroom did not establish substantial noncompliance, because substantial evidence established that the resident did not require a two-person assist for short walks within her room. "Nothing in the record establishe[d] that [the facility] had assessed the resident as needing to move to a two-person assist in ambulating to the bathroom." Koester Pavilion, DAB No. 1750, at 26. On the other hand, the Board reversed Judge Clifton's conclusion that the facility adequately supervised and assisted a second resident, considered an "attention seeker" who would sit on the floor to attract attention. There, as here, no one disputed that the resident could not safely ambulate without assistance. There, as here, a bed alarm had been discontinued with no effective alternative provided. The Board concluded that the regulatory standard was not met.

Where an individual refuses a particular protective device (here, the body alarm), the facility is still responsible under 42 C.F.R. � 483.25(h)(2) for protecting the safety of that person. If the device is to be removed, the facility is obliged to provide another means of supervision or assistance to prevent falls. See generally DAB No. 1726, at 34 (2000).

Certainly, if the facility was sufficiently aware of the resident's proclivity for falling to have installed an alarm to begin with, then appropriate alternative measures should have been put in place if the body alarm was discontinued.

Koester Pavilion, DAB No. 1750, at 27-28.

While I agree with Petitioner that the Koester Pavilion findings regarding the second resident are comparable to those presented here, in light of the Board's final decision reversing the ALJ opinion, I conclude that the facility here was not in substantial compliance with the quality of care regulation, 42 C.F.R. � 483.25(h)(2), because it failed to take reasonable steps to ensure that R18 received supervision and assistance devices to mitigate the risk of harm posed by her late night/early morning wandering, a risk the facility plainly foresaw.

R61: The facility also identified R61 as at high risk for falls. Her care plan and physician orders called for a front release seatbelt on her wheelchair and chair alarms in place whenever she was in her wheelchair or recliner. CMS Ex. 15, at 19; CMS Ex. 21, at 3 � 9.

Surveyor Christine Delph observed R61 sitting unsupervised in her room in her wheelchair at 3:40 p.m. on May 17, 2001. The alarm, however, was on the recliner chair, not the wheelchair. Surveyor Delph called into the room her colleague, surveyor and registered nurse, Judith Young. CMS Ex. 21, at 3 �� 11, 12; CMS Ex. 24, at 4-5. Surveyor Young confirms that at 4:05 p.m. on May 17, 2001, she observed R61 sitting unsupervised in her wheelchair in her room. The chair tender alarm was on the recliner chair, not on her wheelchair. CMS Ex. 19, at 7-8 � 29; CMS Ex. 23, at 8. At 8:50 a.m., on May 18, 2001, Surveyor Delph observed R61 in her wheelchair in the main dining room, with no alarm placed in the wheelchair. She later saw the alarm on the resident's bed. At 9:15 a.m., staff returned R61 to her room, placed her in the recliner chair, but did not apply the alarm. CMS Ex. 21, at 4 � 13; CMS Ex. 24, at 6. At 9:45 a.m., Surveyor Young also observed R61 alone in her room in her recliner, with no evidence of the ordered alarm attached to the recliner. CMS Ex. 19, at 8 � 30. At 12:50 p.m., Surveyor Delph again observed R61 in her wheelchair in the dining room with no alarm in place. CMS Ex. 21, at 4 � 14; CMS Ex. 24, at 6.

The facility does not exactly dispute these specific observations, but counters that, on some of these occasions, R61 was otherwise supervised, pointing to a declaration from Director of Nursing (DON) Lynda Davis. DON Davis was apparently not present on any of these occasions, and has no first-hand knowledge of the findings. Nevertheless, she declares

Affiant [Davis] spoke with staff at Pataskala Oaks who could confirm that R61 was under the supervision of facility staff when she was eating in the dining room. Further, Carol Smith[,] a registered nurse of Pataskala Oaks, has advised Affiant that she was in the room when state surveyor Delph was in the room of R61 and R61 was in her recliner. ⁽⁸⁾ On the above occasions Affiant can attest that R61 was under the supervision of facility staff, therefore providing the necessary care and fall prevention. Affiant will further state that on each occasion the lap belt was in place on the wheelchair preventing R61 from falling or ambulating on her own.

P. Ex. 10, at 1 � 4.

I recognize that, with respect to R61, DON Davis' declaration is not terribly well supported. However, hearsay - even unattributed hearsay - may be admissible in these administrative proceedings, and, for summary judgment purposes, I accept as true her assertions of fact. Moreover, nothing in her declaration is inconsistent with the surveyor declarations. She asserts that "R61 was under the supervision of facility staff when she was eating in the dining room," which is not inconsistent with the surveyor observation that R61 was in the dining room in a wheelchair without the prescribed chair alarm. DON Davis also points to Nurse Smith's assertion that "she was in the room when state surveyor Delph was in the room of R61 and R61 was in her recliner." I'll accept that. What remains is the undisputed fact that staff were not applying the alarm as required by her care plan and ordered by her physician. Summary judgment is generally appropriate when the undisputed facts show that the facility did not follow its own plan of care in providing supervision or assistance devices to prevent accidental injury. Guardian Health Care Center, DAB No. 1943, at 24, citing Lebanon Nursing and Rehabilitation Center, DAB No. 1918, at 9 (citing Windsor Health Care Center, DAB No. 1902 (2003)). For sound reasons, planners might not consider it sufficient to rely on general staff supervision, nor on the application of a lap belt that some residents can manage to remove. Staff are simply not free to disregard the care plan and physician order, as they apparently did here, even if they think they have provided an adequate alternative.

And Petitioner's case is even weaker, since it has not challenged the 3:40 and 4:05 p.m. May 17 observations of R61 sitting unsupervised in her wheelchair in her room, nor Surveyor Young's 9:45 a.m. May 18 observation of R61 sitting unsupervised in her recliner. The uncontroverted evidence thus establishes that the chair alarm was not in place on several occasions. Accepting Petitioner's factual assertions, on some of these occasions R61 was in the presence of staff and presumably under staff supervision. But at least two to three other times, she was left alone and unsupervised, without the required alarms in place.

Because CMS has made a prima facie showing that the facility was not in substantial compliance, and Petitioner proffers no set of facts that, if accepted, would establish its substantial compliance with 42 C.F.R. � 483.25(h)(2), CMS is entitled to summary judgement. Livingston Care Center, DAB CR906, at 6, aff'd DAB No. 1871 (2003), and aff'd No. 03-3489, 2004 WL 1922168 (6^th Cir. 2004) .

C. Petitioner has not challenged the reasonableness of the $500 per day CMP.

I consider now whether Petitioner has preserved the issue of the reasonableness of the amount of the CMP.

CMS argues that the facility has waived any challenge to the amount of the CMP. CMS Brief at 24. In its hearing request, Petitioner challenges the surveyor findings and conclusions, but does not mention any specific challenge to the amount of the CMP. Request for Hearing. By order dated July 23, 2001, I directed the parties to identify the legal issues and factual disputes presented, explaining that these submissions would be used to eliminate extraneous issues, and delineate the scope of the proceedings, and to avoid undue surprise. In its report, filed November 28, 2001, Petitioner again challenges CMS's findings regarding the adequacy of its care, but does not mention the reasonableness of the CMP.

By letter dated January 24, 2002, I directed the parties to submit pre-hearing briefs. In its pre-hearing brief, CMS pointed out that Petitioner had not raised any issue as to the reasonableness of the CMP. CMS Brief at 24. Petitioner subsequently filed its own prehearing brief, which does not mention the reasonableness of the CMP. Finally, in its motion for summary judgment, CMS reiterates that "the reasonableness of the $7,000 CMP has not been appealed." CMS MSJ Brief at 19. In its reply, Petitioner does not challenge CMS's assertions.

Petitioner has thus had multiple opportunities to articulate any challenge to the amount of the CMP, and has not done so. That issue is therefore not before me. See Guardian Health Care Center, DAB No. 1943, at 27; Ross Healthcare Center, DAB No. 1896 (2003).

V. Conclusion

For all of the reasons discussed above, I uphold CMS's determination that from May 18, 2001 through May 31, 2001, the facility was not in substantial compliance with program participation requirements, specifically 42 C.F.R. � 483.25 (Quality of Care).

Carolyn Cozad Hughes

Administrative Law Judge

1. The Sixth Circuit subsequently issued its decision in Livingston Care Center v. Dep't. of Health & Human Services, No. 03-3489, 2004 WL 1922168 (6^th Cir. Aug. 24, 2004). Inasmuch as Livingston Care Center is consistent with Crestview Parke Care Center, I did not consider any further briefing necessary.

2. The SOM was revised on May 21, 2004. However, the definition of an "accident" is unchanged.

3. I make Findings of Fact and Conclusions of Law (Findings) to support my decision in this case. I set forth each Finding, in italics and bold, as a separate heading.

4. An opinion unsupported by a rationale or reference to specific facts is insufficient to create a triable issue. Guardian Health Care Center, DAB No. 1943, at 13, citing Shaw by Strain v. Strackhouse, 920 F.2d 1135, 1144 (3d Cir. 1990) (expert affidavits that are conclusory and lacking in specific facts are insufficient to create a genuine factual dispute), and United States v. Various Slot Machines on Guam, 658 F.2d 697, 699-701 (9 ^th Cir. 1981). Here, Administrator Isbister opines that the nighttime wandering was "significantly reduced," but offers no specific facts to support that opinion.

5. Nor does she claim that R18 could walk the halls safely at that time. Based solely on her review of the nurses' notes, she observes that when R18 was admitted to the facility she was able to walk safely even though she took psychotropic medications, a statement that is supported by R18's treatment record. However, Administrator Isbister does not dispute that by January 2001, R18 was no longer able to walk safely. Hence she opines that "with implementation of the use of the wheelchair . . . proper and least restrictive devices were in place." (Emphasis added). P. Ex. 6, at 2 � 12. No one disputes that R18 was able to move safely about so long as she was restrained in her wheelchair.

6. A gap appears in the nursing notes. No entries are provided from January 27, 2001, until February 15, 2001. P. Ex. 11, at 7-8; CMS Ex. 29, at 1-2. Nor do the nursing notes record every instance in which R18 was wandering the halls. Compare P. Ex. 11, at 19, where nursing notes for March 14, 2001, make no mention of the behavior, with CMS Ex. 30, at 2, in which a "Behavior Monitoring Intervention Flow Record" indicates that she "ambulated into hallway from [room], awake, restless, wouldn't go back to bed."

7. Other possible measures include a pressure alarm, a motion sensing alarm, more frequent checks, and addressing the psychological causes of the resident's desire to wander. See, e.g., CMS Ex. 19, at 7 � 25. Petitioner mentions in its brief that R18 was moved to a room closer to the nurses' station, but provides no support for this claim. P. MSJ Response at 7. A March 15, 2001 entry in the Social Service Progress Notes indicates that "[R18] will be receiving a new roommate this day." P. Ex. 9, at 1. This does not establish that her room was changed. Neither the nurses' notes nor declarations of witnesses mention any such room change. See P. Exs. 6, 7, 8, 10, 11, 12, 16. Most dispositive, her records prior to March 15 consistently place her in room 11B. P. Ex. 1, at 1, 5 et seq.; P. Exs. 3, 4, 5. Records dated on or after March 15 place her in room 11B. P. Ex. 4, at 10, 11. Counsel's unsupported assertions are not competent evidence and are properly disregarded. Community Nursing Home, DAB No. 1807, at 12 n.5 (2002); accord Lebanon Nursing and Rehabilitation Center, DAB No. 1918, at 2 ("[Arguably] no genuine dispute on the issue of noncompliance would be raised if the facts alleged in the declarations were clearly inconsistent with the resident's treatment records.")

8. Petitioner offers no declaration from Nurse Smith.