SUBJECT:

Bethel Center,

Petitioner,

Centers for Medicare & Medicaid Services.

DECISION

I sustain the determination of the Centers for Medicare & Medicaid Services (CMS) to impose remedies against Petitioner, Bethel Center, consisting of civil money penalties of: $6,000 per day for each day of a four-day period that began on March 11, 2005 and which ran through March 14, 2005; and $100 per day for each day of a period that began on March 15, 2005 and which ran through April 18, 2005.

I. Background

Petitioner is a skilled nursing facility in Arpin, Wisconsin. It participates in the Medicare program. Its participation in Medicare is governed by sections 1819 and 1866 of the Social Security Act (Act) and by federal regulations at 42 C.F.R. Parts 483 and 488.

Petitioner was surveyed for compliance with Medicare participation requirements in a survey that extended from March 8 through March 16, 2005 (March survey). The surveyors, who were employed by the Wisconsin Department of Health & Family Services, found that Petitioner failed in several respects to comply with Medicare participation requirements. The deficiencies found by the surveyors included two that the surveyors determined to be so egregious as to place residents of Petitioner's facility in a state of immediate jeopardy. The surveyors subsequently concluded that Petitioner abated its immediate jeopardy noncompliance on March 14, 2005 and that Petitioner re-attained substantial compliance with all Medicare participation requirements on April 18, 2005.

CMS concurred with the surveyors' findings and determined to impose the civil money penalties that I cite in the opening paragraph of this decision. Petitioner requested a hearing and the case was assigned to me for a hearing and a decision. I directed the parties to file opening briefs and to exchange proposed exhibits. In its opening brief Petitioner made it clear that it was challenging only the two findings of immediate jeopardy level deficiencies that were made at the March survey and CMS's determinations as to penalty amounts. It did not challenge the findings that non-immediate jeopardy level deficiencies were present as of the March survey nor did it challenge CMS's determination as to duration of noncompliance of non-immediate jeopardy level deficiencies.

I scheduled an in-person hearing. Prior to the hearing the parties informed me that they had agreed that the case could be tried based on their written exchanges. Consequently, I canceled the in-person hearing and allowed the parties to submit additional briefs. Each party submitted an additional brief and a reply brief.

CMS offered proposed exhibits consisting of CMS Exhibit (Ex). 1- CMS Ex. 56. As part of its initial exchange Petitioner offered proposed exhibits consisting of Petitioner (P.) Ex. 1 - P. Ex. 30. Petitioner then offered additional exhibits consisting of P. Ex. 31 - P. Ex. 41, which it submitted on July 21, 2006, with its supplemental brief. Petitioner does not oppose my receiving CMS's proposed exhibits into evidence. CMS does not object to my receiving P. Ex. 1 - P. Ex. 30 into evidence but it opposes my receiving P. Ex. 31 - P. Ex. 41 into evidence on the ground that Petitioner submitted these proposed exhibits untimely.

I receive into evidence CMS Ex. 1 - CMS Ex. 56 and also P. Ex. 1 - P. Ex. 41. I do not find that CMS is prejudiced by my receiving P. Ex. 31 - P. Ex. 41 into evidence. CMS had one full month to reply to these exhibits with supplemental exhibits of its own, if it wished to do so.

II. Issues, findings of fact and conclusions of law

A. Issues

As I discuss above Petitioner has not challenged the findings of non-immediate jeopardy level deficiencies that were made at the March survey nor has it disputed CMS's determination that non-immediate jeopardy level deficiencies persisted at Petitioner's facility through April 18, 2005. It has challenged the presence of immediate jeopardy level deficiencies during the March 11-14 period and it has disputed the penalty amounts of $6,000 per day and $100 per day that CMS determined to impose. Therefore, the issues in this case are whether:

1. Petitioner manifested one or more immediate jeopardy level deficiencies during the March 11-14, 2005 period; and

2. The civil money penalties that CMS determined to impose are reasonable.

B. Findings of fact and conclusions of law

I make findings of fact and conclusions of law (Findings) to support my decision. I set forth each Finding below as a separate heading and I discuss each Finding in detail.

The weight of the evidence in this case establishes that Petitioner was deficient in providing care to its residents. The evidence addresses the care Petitioner provided to residents of its facility who were at risk for sustaining falls. As I discuss in detail below several of Petitioner's residents were at great risk for sustaining falls. These individuals were generally elderly, frail, and in some cases demented residents who were incapable of protecting themselves from falling. The residents' histories, both prior to and while at Petitioner's facility, contained overwhelming evidence that these residents needed urgent and special protection against falling. Yet, Petitioner failed to plan aggressively to protect these residents against falls. It failed to assess residents for fall risks. It failed to modify residents' standardized care plans to incorporate changes in residents' treatment prompted by their falls. It failed to develop or implement measures that might have provided better protection for its residents despite the fact that several of them fell repeatedly. Some of the measures that it relied on - particularly bed and seat alarms - were palpably ineffective. Yet, Petitioner persisted in relying on these aids without developing more effective protection for its residents and despite being confronted with repeated instances in which the alarms failed to provide staff with sufficient warning of an imminent fall or even to work at all.

Petitioner's essential deficiency was its failure to provide these residents with the close supervision that they needed. The evidence strongly supports my conclusion that the residents whose care is at issue needed to be supervised closely by Petitioner's staff. However, the staff failed to provide these residents with close supervision. Instead, it relied on devices such as alarms to "protect" the residents in circumstances where only close supervision would suffice. Residents fell, and fell repeatedly, and notwithstanding, Petitioner continued to rely on interventions other than close supervision, such as chair and bed alarms, that were demonstrably not protecting the residents.

The evidence also provides overwhelming support for a finding that Petitioner's noncompliance was at the immediate jeopardy level. There is compelling proof in this case that Petitioner's deficiencies seriously harmed, or were likely to cause serious injury, harm, or death to one or more of Petitioner's residents. Finally, the weight of the evidence strongly supports my conclusion that the civil money penalty penalties that CMS determined to impose were reasonable both in amounts and duration.

1. Petitioner failed to comply substantially with the requirements of 42 C.F.R. � 483.20(k)(3)(i).

The regulation that is at issue here provides that services arranged for or provided by a facility must meet professional standards of quality. It is a subpart of a regulation which mandates, generally, that a facility must conduct a comprehensive assessment of each resident's needs and write a comprehensive care plan explaining how that resident's needs will be met. 42 C.F.R. �� 483.20, 483.20(k). CMS alleges that Petitioner failed to comply with regulatory requirements because it did not follow professionally recognized standards of care relating to development and implementation of fall prevention policies and procedures and, individualized care plans directed at preventing resident falls. CMS's initial hearing brief at 27. More specifically, CMS asserts that Petitioner failed to comply with regulatory requirements because it failed to assess residents' fall risks prior to and after the residents sustained falls, failed to assess thoroughly residents after they sustained falls to determine what interventions should be implemented to protect the residents, and failed to develop care plans for its residents with individualized fall protection interventions. Id.

The evidence more than substantiates these contentions. Professionally recognized nursing standards of practice require that a facility actively identify those residents who are at risk for falls and develop and implement actions - individually tailored to the specific needs of individual residents - that are designed to protect residents against falling. It is not sufficient for a facility simply to respond to falls as they occur. CMS Ex. 48, at 2; CMS Ex. 49, at 2; CMS Ex. 50, at 2. Actions that a facility must take in order to protect its residents against falling consist not only of making comprehensive assessments of the residents' problems and needs but of creating, based on the assessments, detailed care plans containing specific measures that are designed to protect residents against falling. CMS Ex. 48, at 3-4. Moreover, when repeated falls establish that an intervention in a care plan is not working, a facility is obligated to revisit the resident's problems and, if necessary, revise the resident's care plan in order to implement new and more effective interventions.

Petitioner argues that it is bound only by professional standards of care that are described in accepted clinical literature. Petitioner's pre-hearing brief at 26. I do not find this argument to be persuasive. A standard of care need not be set forth in clinical literature if it is so widely accepted as to be commonly utilized within a health care profession. ⁽¹⁾ However, the evidence in this case establishes that there are in fact well-documented requirements that residents be assessed carefully and thoroughly for possible fall risks, and that a facility develop and aggressively implement fall prevention measures tailored to meet the needs of individual residents.

Indeed, Petitioner was aware of these requirements. An exhibit submitted by Petitioner, entitled "Premier Fall Prevention" states that:

Implementing a successful falls prevention program requires a systematic method for identifying patients or residents who are at a higher risk for falling . . .

P. Ex. 25, at 6. Material published by the American Medical Directors Association and also submitted by Petitioner as an exhibit states:

The process of addressing falls prevention is similar to that of other clinical problems, and should include the following elements: assessment; diagnosis and cause identification . . . setting the goals and objectives for care in the context of resident wishes and advanced directives; care planning; management of risks and complications (any injuries from a fall); and monitoring and periodic reevaluation of the care plan.

P. Ex. 26, at 2.

Measured against this standard Petitioner's performance in assessing and planning for fall risks was deficient. Petitioner lacked an overall policy for planning to protect residents against fall risks and it failed to plan comprehensively to address the fall risks encountered by individual residents.

Petitioner had no policy directing its staff to assess residents for fall risks and to determine what would be needed to protect residents against falling. Its policy concerning falls only instructed the staff what it should do in the event that a resident actually fell. CMS Ex. 37, at 1.

Petitioner did not perform comprehensive fall risk assessments of its residents. CMS Ex. 48, at 4. During the March survey a surveyor requested a member of Petitioner's staff to produce copies of fall risk assessments made for certain residents. The surveyor was told that Petitioner's staff had been instructed by the facility's owner not to perform fall risk assessments. Id. This admission is buttressed by Petitioner's inability to produce any fall risk assessments that were completed after November 2, 2004. See P. Ex. 2, at 2-3.

Examination of residents' records underscores my conclusion that Petitioner failed to perform comprehensive fall risk assessments. Documents that Petitioner completed for its residents addressed their risks for falling in some respects but they were not, either by themselves, or in combination, comprehensive assessments of the residents' risks for falling. Importantly, none of the documents prepared by Petitioner's staff after November 2004 contain a detailed analysis of residents' risks for falling nor do they contain comprehensive plans for dealing with whatever risks the residents manifested.

For each of its residents Petitioner completed a nursing admission/readmission assessment. P. Ex. 12, at 3-4. This document did not address comprehensively residents' fall risks because it omitted to discuss in detail issues such as residents' ability to ambulate without assistance or whether residents had problems such as gait disturbances that predisposed them to falls. P. Ex. 2, at 8-9. Other documents prepared by Petitioner's staff, such as the Minimum Data Set Assessment (MDS) and Resident Assessment Protocol (RAP), failed also to address comprehensively residents' risks for falling. Although these documents contain information that is relevant to assessing residents' fall risks neither of them contain assessments or analyses of that information that would allow staff to determine exactly what risks existed and how to address them. For example, RAPs completed for a resident who is identified as Resident # 9 contain summaries of the resident's problems. CMS Ex. 25, at 22-24. But, they do not contain analyses of the causes of these problems nor do they discuss what should be done to address them.

Petitioner's staff, for the most part, adequately documented the details of falls that residents sustained. However, the staff failed to use the information that they collected about residents' falls to plan comprehensively to prevent residents from sustaining additional falls. CMS Ex. 48, at 3. Frequently, Petitioner would continue using the same interventions it had attempted previously with a resident, in the face of evidence, consisting of a documented fall or falls, that the interventions were not working to prevent falls. Id.

Petitioner's staff often failed to modify residents' care plans to address problems that were identified as a consequence of falls. For example, a resident who is identified as Resident # 9 sustained more than 20 falls in a period of less than a year. CMS Ex. 25, at 28, 32, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 64, 68, 71, 75, 78, 82, 85, 88, 91, 97. After a fall that the resident sustained on September 30, 2004, Petitioner's interdisciplinary team directed Petitioner's staff to toilet the resident whenever he attempted to get out of his wheelchair. Id. at 47. However, the resident's care plan was not modified to reflect this change in the resident's treatment regime. The resident sustained an additional fall on January 17, 2005, which prompted his physician to order that the resident's seat belt be modified. Id. at 14, 178. The resident's care plan was not modified to reflect this change in treatment.

Petitioner argues that, in fact, it did assess its residents for fall risks and plan effectively to address those risks. It contends that as of the March survey the fall prevention services that it provided to its residents went above and beyond the call of duty. Petitioner's pre-hearing brief at 27. Notwithstanding this contention Petitioner did not rebut the evidence that I discuss above showing that it did not assess comprehensively all of its fall-prone residents for their fall risks or plan effectively in all instances to address problems as they were observed.

For example, Petitioner's current administrator averred that a resident assessment examination form is completed for each of Petitioner's residents at least quarterly, after a routine physician visit is completed. P. Ex. 12, at 7. According to the administrator:

The front page is completed by the nurse before the physician's visit, and includes Fall Risk, number of falls in past two months, any restraint use, bed/chair alarm use, and any enabler use.

Id. Petitioner cited to no examples of this form. However, assuming that the administrator's allegations are accurate, the form as described by her is not the comprehensive fall assessment that professionally recognized standards of practice require that a facility complete for each of its residents. Rather, as described by Petitioner, the form is a summary of the resident's history. Such a summary may be a necessary element of a fall assessment but it does not provide the analysis and planning that is mandated by professionally recognized standards of nursing care.

Petitioner also argues that assessment of fall risks was an "ongoing process" at its facility. Petitioner's pre-hearing brief at 27. In support of this contention, Petitioner's administrator asserted that, when a resident fell, the staff completed documents, including an "Event Report Sheet" that contain an assessment of the resident's needs. P. Ex. 12, at 8. Petitioner offered no specific examples of this document nor did it describe exactly what is assessed in Event Report Sheet.

Although Petitioner did not provide a detailed discussion of the contents of its Event Report Sheets, there are examples of the document in evidence and so it is possible to discern exactly what the document describes. E.g., CMS. Ex. 25, at 36. It is evident from examination of the document that it does not comprise an assessment that comports with professionally recognized standards of care. The Event Report Sheet contains a printed section entitled "Initial Assessment," which contains information including a resident's mental status following a fall, environmental factors such as whether the resident needs to be assisted to the toilet, and the resident's vital signs. Id. But, what it does not contain is any analysis of why the resident fell or an analysis of what might be done to prevent future falls. In other words, the "assessment" is not really an assessment so much as it is a summary of information that one might use to assess a resident who fell.

Petitioner contends, in addition, that it used individualized approaches for fall prevention in order to meet its residents' needs. Petitioner's pre-hearing brief at 28. It may be that in some cases Petitioner's staff did come up with specific solutions to residents' problems. But that does not address CMS's argument - supported by the evidence - that there were instances in which Petitioner failed to do so.

2. Petitioner failed to comply substantially with the requirements of 42 C.F.R. � 483.25(h)(2).

The relevant regulation requires a facility to provide its residents with adequate supervision and assistance devices to prevent accidents. The regulation does not make a facility strictly liable for every accident that occurs on its premises but it requires a facility to do everything within its power to protect residents against accidents that are foreseeable.

Petitioner asserts that its duty to provide adequate supervision and assistance to residents was limited only to providing supervision that was "barely sufficient" or "reasonably sufficient." Petitioner's supplemental brief at 5. I am not certain what Petitioner means by this argument but I am unpersuaded that Petitioner was obligated to provide its residents with anything less than that which I have stated to be its duty. A central reason for housing a resident in a skilled nursing facility is to provide that resident with care, including supervision, that the resident is unable to provide for himself or herself or that the resident's family is unable to provide at home. Under the applicable regulation that duty includes doing whatever is within the facility's capability to provide the resident with supervision and assistance.

Compliance with 42 C.F.R. � 483.25(h)(2) requires a facility to assess its residents' status continuously so as to be able to confront problems as they develop and to evaluate the efficacy of measures instituted to deal with residents' needs and problems. It is not sufficient for a facility to rely on protective measures for its residents if events show that these measures are ineffective. If protection is ineffective a facility is obliged to attempt new measures until it either develops an approach that works or exhausts all possible avenues of protection.

CMS alleges that Petitioner failed to comply with regulatory requirements in providing care to four residents, identified as Residents #s 22, 3, 9, and 17. All four of these residents were frail individuals with physical problems and dementia or other mental problems that put them at risk for sustaining falls. Resident # 22 suffered from impairments that included Parkinson's disease, grand mal epilepsy, blindness, dementia, and disorientation. CMS Ex. 35, at 1, 10, 16. Resident # 3 had Alzheimer's disease, Parkinson's disease, and osteoarthritis, among other problems. CMS Ex. 19, at 1. Resident # 9 suffered from Alzheimer's disease. CMS Ex. 25, at 10. Resident # 17 had Alzheimer's disease along with other problems including pneumonia and a fractured femur. CMS Ex. 30, at 1. During the months that preceded the March survey all of these residents sustained falls. Resident # 3 fell 18 times in the 12 months preceding the survey. Resident # 9 fell 23 times during roughly the same time period.

The crux of CMS's case is that Petitioner failed to provide adequate assistance and supervision to these four residents to prevent them from falling. The evidence offered by CMS to support this contention is persuasive and not rebutted by Petitioner. The evidence establishes that there were two dimensions to Petitioner's deficiency. First, Petitioner failed adequately to assess residents after they sustained falls and failed to implement new and effective interventions to prevent residents from sustaining additional falls. Second, Petitioner relied on bed and chair alarms for its fall-prone residents in lieu of intensive personal supervision of these residents. But, these alarms manifestly failed to protect residents from falling. On some occasions staff responded to alarms too late to provide meaningful protection to falling residents. On other occasions alarms simply failed to work. The evidence establishes that Petitioner persisted in utilizing these alarms in lieu of personal supervision even after it became obvious that the alarms were not providing residents with adequate protection against falls.

a. Petitioner failed to provide adequate post-fall assessments of its residents and to plan aggressively new interventions to prevent residents from sustaining additional falls.

I have discussed Petitioner's general failure to assess its residents appropriately for fall risks above, at Finding 1. In this subpart, I focus more closely on Petitioner's response to specific instances of resident falls. The professionally recognized standard of care governing residents who sustain falls requires a careful reassessment of a resident's condition after each fall. CMS Ex. 48, at 3-4. When a resident falls a facility's staff must reassess the resident to determine the cause of the fall and to determine if new interventions need to be implemented to prevent the resident from falling again. Id. In performing this assessment the staff should look at specific aspects of the resident's condition and his or her activities in order to understand what caused the fall, but also to decide what should be done to protect the resident against recurrences. Id.

The evidence strongly supports the conclusion that Petitioner failed to satisfy this standard in providing care to Residents #s 22, 3, 9, and 17. I do not find that Petitioner ignored these residents or that it failed to provide them with new interventions on occasion. But, it failed systematically to assess them for fall risks after they fell consistent with that which is required by the professionally recognized standard of care and consequently it failed to develop coherent or effective measures to prevent future falls. Petitioner's failure to provide these residents with systematic assessments of their fall risks and with comprehensive planning against the risk of future falls greatly increased the likelihood that these residents would sustain additional falls.

i. Resident # 22.

Petitioner's staff knew that Resident # 22 was at a high risk for sustaining falls. CMS Ex. 35, at 7. In fact, the resident fell on three occasions during the year prior to the March survey, on April 28, 2004, May 9, 2004, and February 9, 2005. Id. at 9, 12, 16. The resident sustained a fractured hip as a consequence of the last of these falls. Each of the falls sustained by Resident # 22 occurred under essentially identical circumstances. In each instance the resident attempted to get out of his bed while unattended early in the morning. CMS Ex. 35, at 10, 14, 17. After the resident sustained each of his falls, Petitioner's staff completed an event report sheet that described the circumstances of the fall. Id. at 9, 13, 16. The staff also filled out a customer fall investigation form after each fall that contained additional information about the circumstances of the fall. Id. at 10, 14, 17. And, after each fall, Petitioner's staff completed an interdisciplinary team fall review. Id. at 11, 15, 18. This review summarized the resident's condition and described the interventions used previously for the resident as well as contemplated interventions.

There is no question that the documents that Petitioner's staff prepared after each of the resident's falls contain information that is pertinent to the event and even necessary to help the staff plan against future similar incidents. But, what none of these documents contains is an analysis of the reasons for the resident falling or a focused plan that addresses, in a logical manner, the new interventions that, hopefully, would prevent the resident from falling again. Most evident is that the interventions listed by Petitioner's staff do not appear to reflect a close analysis of what was working and what was not nor do they appear to be intended to address aggressively risks that might have been identified after each fall. Indeed, the various documents don't really explain what the resident's risks for falling were, how interventions might help the resident, or why previously instituted interventions failed.

After the resident's April 28, 2004 fall, the interdisciplinary fall team review listed the interventions that had been in place prior to the fall ("alarms, keeping environment clutter free, frequent monitoring, therapies, restraints in the past in his . . . [wheelchair]"). CMS Ex. 35, at 11. But, it contains no discussion of why these interventions failed to prevent the April 28, 2004 fall, nor does it contain any analysis of what else might be provided to the resident in lieu of or in addition to the interventions that were in place previously. Id. Under the heading "Interventions/plans" the review states that the staff would "continue current plan of care." Id. The staff gave no explanation for this decision other than to state - with apparent hopelessness - that the resident continued to have occasional falls. Id.

The interdisciplinary team fall review that Petitioner's staff prepared after the resident's May 9, 2004 fall is similar. Again, it lists the interventions that were being attempted for the resident prior to the fall, but without any explanation as to why the resident fell despite these interventions. CMS Ex. 35, at 15. The review lists no new interventions other than to check the resident's alarm and to continue an ambulation program and positioning of the resident. Id. It states, laconically, that "falls will continue to be a problem" without explaining why that was so and without any analysis of what Petitioner's staff might do to reduce the resident's risk of falling. Id.

The review conducted after the resident's February 9, 2005 fall is similarly devoid of analysis or planning. CMS Ex. 35, at 18. It lists as new interventions that the resident would receive a bed alarm and a taco mattress. ⁽²⁾ Id. But, it contains absolutely no analysis of why the resident sustained this last fall - in the face of interventions previously implemented by Petitioner - nor does it contain any analysis of why the new interventions listed in the review might help him. Id. The review does not, for example, explain why the staff thought that a taco mattress would prevent the resident from getting out of bed while unattended.

I do not find Petitioner's response to this evidence to be persuasive. Petitioner emphasizes that, in the case of Resident # 22, it completed the documents that I have discussed. It asserts that it conducted an interdisciplinary review of every fall sustained by the resident. These assertions do not confront the central issue raised by the evidence. There is no question that Petitioner's staff documented Resident # 22's falls and that it met to discuss them. But, what it failed to do - and what it was required to do by 42 C.F.R. � 483.25(h)(2) - was meaningful analysis and planning with the aim of better protecting the resident. The exhibits in this case simply do not show that Petitioner did that.

Petitioner also argues with respect to all four of the residents whose care is at issue, including Resident # 22, that it was not required to implement new interventions after each fall sustained by a resident. Petitioner's supplemental brief at 6. According to Petitioner:

It is sufficient if . . . [it] shows it assessed the resident and determined if additional interventions to prevent falls were appropriate.

Id. I agree with Petitioner that its duty to each resident is to make an assessment after each fall and to determine what, if any, changes to that resident's care are warranted. And, it is within the realm of possibility that there might be instances where a facility decides reasonably that it had done all that it was able to do and the resident fell notwithstanding. But, that is not to say that a facility's obligation to a resident when the resident falls consists solely of going through the formality of a post-fall investigation and assessment process. What the facility does after a resident falls must be meaningful. The post-fall investigation must be a thorough analysis of what caused the fall and what may be done to prevent future falls. The evidence in this case shows that, with respect to Resident # 22 and the other three residents as well, Petitioner completed the formality of post-fall inquiries but without meeting its substantive obligations.

Petitioner also argues that, in the case of Resident # 22 and the other three residents whose care is at issue, it is being judged unfairly. Petitioner contends that CMS presumes it to be deficient based essentially on the fact that the residents sustained falls. Petitioner's supplemental brief at 6-7. According to Petitioner it is being held to an unfairly strict standard which fails to take into account all of the positive actions it took on its residents' behalf.

I disagree. I do not find Petitioner to be deficient in its care of Resident # 22, or in the care it provided to the other three residents whose care is at issue because these residents fell. The deficiency lies in what Petitioner failed to do about those falls after they occurred. The evidence in this case overwhelmingly shows that Petitioner failed to perform the assessment and planning that the regulation requires. That is the basis for Petitioner's deficiency.

ii. Resident # 3

Resident # 3 was a resident who fell often. The record documents at least 18 falls by the resident in an approximately one-year period. CMS Ex. 19. Frequently, the resident would fall while seated in his wheelchair, either by toppling out of the chair or sliding out of it. Id. at 29, 34, 37, 40, 43, 49, 59, 63, 71. The resident fell in other circumstances as well. On more than one occasion the resident fell while attempting to transfer himself from his wheelchair to his bed or from his bed to his wheelchair.

The evidence that describes the care that Petitioner gave to Resident # 3 shows a similar pattern of failures to provide meaningful assessments and to develop responsive interventions after falls as was the case with Resident # 22. Petitioner prepared the same type of documents after each of Resident # 3's falls as it prepared for Resident # 22. CMS Ex. 19, at 22-81. As is true with Resident # 22, these documents show that Petitioner's staff faithfully reported the falls that occurred. The evidence shows that there were interdisciplinary meetings after the falls at which Petitioner's staff discussed the falls. Id. But what is again lacking is evidence of meaningful analysis of the reasons why previously instituted interventions were not working to protect adequately the resident from sustaining falls. Nor did Petitioner's staff explain why new interventions - when they were attempted - were expected to ameliorate the resident's situation.

The interdisciplinary reviews that were prepared by Petitioner's staff after Resident # 3 sustained his numerous falls never came to grips with the essential problem faced by the resident. The resident was at great risk while left unattended in his wheelchair. He fell repeatedly in that circumstance. The resident clearly was in need of close supervision while in his wheelchair, but in other circumstances as well, due to his unsteadiness, his various illnesses, and his dementia. CMS Ex. 48, at 9-10. The interdisciplinary reviews prepared by Petitioner's staff acknowledge that the resident was at risk while in his wheelchair. They discuss interventions tried previously with the resident and mention, at times, new interventions. Typically, however, the interdisciplinary review that was conducted after each such fall is opaque as to what circumstances could be causing the resident to sustain these falls and it fails to discuss whether Petitioner's treatment regime for the resident was adequate. At no point do any of these reviews acknowledge that the resident was in need of far more intensive supervision than the staff had been providing to him. CMS Ex. 19, at 29, 33, 36, 39, 42, 44, 48, 52, 58, 62, 66, 70, 73, 77, 81.

Moreover, some of the interventions that Petitioner's staff developed for Resident # 3 did not seem to address the reasons for a particular fall or falls that were sustained by the resident. For example, on August 21, 2004, the resident apparently fell as he was attempting to get out of bed. CMS Ex. 19, at 31. But, the intervention that Petitioner's staff developed in response to this fall was that the resident would use a wheelchair for unsteadiness. Id. at 33. Petitioner's staff offered no explanation as to why this intervention might deal with the type of fall that the resident had sustained. Id.

Petitioner makes essentially the same arguments concerning the care it gave to Resident # 3 as it makes with respect to the care it gave Resident # 22. I find them to be unpersuasive here, as I do in the case of Resident # 22. Petitioner goes to great lengths to enumerate the forms its staff completed in the wake of the resident's falls and the interventions it attempted. But, it fails to address the central point of CMS's argument and the evidence in this case, the failure of the staff to assess the reasons for the resident's many falls and its failure to develop interventions that address the underlying reasons for the falls. Petitioner never explains why it did not consider supervising Resident # 3 more closely given the many falls that the resident sustained while unsupervised.

iii. Resident # 9

Resident # 9 suffered from dementia with long- and short-term memory deficits. CMS Ex. 25, at 21. His dementia and infirmities were such that he required assistance with daily living activities. Id. The resident's dementia and confusion caused him to not recognize his infirmities. Id. Resident # 9 fell more than 20 times in the year prior to the March survey. Generally, these falls occurred either from the resident's wheelchair or while the resident was in bed. Id. at 19-102.

The obvious problem posed by Resident # 9 was his tendency to fall when not supervised closely by Petitioner's staff. Handicapped by his dementia, the resident would forget to ask for assistance when he needed it. CMS Ex. 25, at 21. He would attempt to do something that he was incapable of doing - such as rising from his bed or his wheelchair unassisted - and would fall. The resident's treatment record contains many reports of the resident being discovered by members of Petitioner's staff, by other residents, or by visitors to the facility after the resident had fallen while unsupervised. CMS Ex. 25, at 28, 36, 39, 42, 45, 57, 61, 64, 68, 71, 75, 78, 82, 94.

As with the other residents whose care is at issue, Petitioner's staff prepared an event report sheet, a customer fall investigation form, and an interdisciplinary review after the resident's falls. CMS Ex. 25, at 19-102. These documents generally describe the circumstances of each fall, the interventions that had been in place, and the new interventions that Petitioner's staff contemplated attempting for the resident. But, as is the case with the other residents whose care is at issue the various reports and reviews prepared by Petitioner's staff fail to come to grips with or even identify the principal problem faced by Resident # 9, nor do they discuss any solution that realistically dealt with that problem.

It should have been evident to the staff that the various interventions that they attempted for Resident # 9 were inadequate. For example, at one point the staff attached a seat belt to the resident's wheelchair. But, the resident defeated that measure simply by unbuckling the seat belt. The need to watch Resident # 9 more closely - if necessary, to put him under continuous observation - was glaringly obvious from the record of his many unsupervised falls. The resident continued to fall, again and again, while unsupervised. But, notwithstanding this history, the staff evidently did not contemplate that the resident needed more intensive supervision than he was receiving.

Petitioner's response to the evidence showing its failure to address Resident # 9's principal problem - his tendency to fall while unsupervised - is to list all of the interventions that it put into place for the resident. These interventions include, among other things, placement of the resident's bed, the use of a taco mattress, bed and seat alarms, and screening of the resident for pneumonia. However, these interventions, while not necessarily inappropriate, simply do not address the problem posed by the resident. They are no substitution for the supervision that the resident palpably needed but failed to receive.

iv. Resident # 17

Resident # 17 was an individual whom Petitioner knew was prone to falling. Indeed, the resident was admitted to Petitioner's facility in October 2004 so that she could recover from a fall which fractured her hip. CMS Ex. 30, at 5. The resident was of very advanced age (94 years) and was not weight bearing as a consequence of her fall. The resident's ability to make decisions was compromised as a result of her dementia. Id. at 6.

The resident fell twice while she was at Petitioner's facility. On November 7, 2004, the resident fell from her bed, injuring her forehead. CMS Ex. 30, at 6. On December 26, 2004, the resident fell again while attempting to get out of her wheelchair. Id. at 7. After each fall Petitioner's staff completed an interdisciplinary fall team review. Id. at 6-7. The reviews that the staff performed for Resident # 17 are quite similar to those that were completed for the other three residents whose care I discuss in this subpart. They describe the circumstances of the fall (on each occasion the resident was discovered by staff after she had fallen). Id. They conclude that the resident, although alert and oriented to herself, did not fully understand the need to ask for assistance. Id. at 7. They list the interventions attempted previously with the resident. The "interventions/plans" listed after the November 7, 2004 fall consist of continuing the resident's bed alarm and continuing physical and occupational therapy. Id. at 6. After the December 26, 2004 fall the staff discussed putting the resident on levaquin, an antibiotic, and having x-rays done of the resident's right knee, hip, and her pelvis. Id. at 7.

But, what these reviews fail completely to do is assess why the resident was continuing to fall while she was at Petitioner's facility and to come up with a plan to address the falls. Petitioner's own documents describe this resident as not weight bearing but at the same time being so confused as to be unable to know when to ask for assistance. That was an obvious recipe for trouble. A reasonable assessment of the resident would have concluded that the resident was at risk for falls while unsupervised because of her physical limitations and her dementia. But, Petitioner's staff never appear to have reached that conclusion nor did they propose any interventions to deal with this obvious problem.

This resident - as is true with other residents at Petitioner's facility - had a bed alarm and a chair alarm. CMS Ex. 30, at 6, 7. Although Petitioner's reviews of the residents' falls do not say so specifically, I infer that Petitioner's staff relied on alarms to warn it of instances in which the resident attempted to engage in activity unassisted that was dangerous. I discuss in detail, at subpart b. of this Finding, why Petitioner's use of bed and seat alarms did not adequately protect residents against accident hazards. It is sufficient for me to say here that it is obvious that Resident # 17 did not benefit from the use of alarms in her case. On two occasions the resident fell despite the presence of alarms. The conclusion I reach from these facts is that, assuming the alarms were functioning, they did not provide Petitioner's staff with sufficient time to react to the resident's activity and to prevent her from falling.

An alarm is a device that, potentially, assists a facility's staff in protecting a resident from accidents. If it operates correctly the alarm may provide a useful warning to the staff that a resident is attempting something that is dangerous to himself or herself. However, the use of alarms by a facility, while arguably beneficial, does not substitute for appropriate supervision of accident-prone residents. Alarms may enhance supervision but are never substitutes for it. With respect to Resident # 17, it is clear that the alarms were not providing Petitioner's staff with sufficient lead time to enable the staff to prevent the resident from falling. Petitioner should have recognized that fact after the resident's first fall in November 2004 and should have adjusted its supervision of the resident accordingly. But, the reviews that Petitioner prepared establish that Petitioner failed to do that.

Petitioner argues that it did not aggressively intervene to protect Resident # 17 because such action would have undercut Petitioner's goal to make the resident sufficiently independent so that she could transfer out of the facility. P. Ex. 12, at 10. I find this argument to be unpersuasive. Petitioner has not explained how protecting this resident against falling would have prevented the resident from becoming sufficiently independent to be able to transfer out of the facility. Activities such as occupational and physical therapy, both of which were provided to the resident, had the potential of benefitting her. But, Petitioner has not explained why such activities would have lost their efficacy had Petitioner been provided with greater supervision.

b. Petitioner's reliance on bed and chair alarms failed adequately to protect its residents against falling.

As I discuss above, bed and chair alarms may be useful to enhance personal supervision of accident-prone residents. However, under no circumstances are such alarms a substitute for adequate personal supervision.

That becomes apparent immediately when one considers how an alarm works. I take notice that alarms are sensitive, either to release of pressure, or to the detachment of a cord that connects a resident to an alarm. When it functions correctly, an alarm will sound when a resident attempts to rise from his or her bed or his or her chair, warning a facility's staff that the resident is in the process of engaging in an activity that is dangerous to the resident. In the best of circumstances, a properly functioning alarm will give a facility's staff a few seconds warning of an inappropriate action. If the staff member is able to reach the resident within those few seconds then, hopefully, the resident may be assisted. But, the alarm is useless as an assistance device if the staff member is too far from the resident when the alarm sounds to come to the resident's assistance and prevent the resident from falling. Consequently, in every case where an alarm is used as an assistance device, facility staff must be no more than, at most, a few seconds and just paces away from the resident in order for the resident to be protected adequately.

It is also obvious that an alarm must function properly in order to be an adequate assistance device. An alarm which fails to sound when a resident attempts an inappropriate activity is worse than useless because the staff may have been lulled into a false sense of security by assuming that the alarm would work as advertised.

The evidence strongly supports the conclusion that Petitioner used alarms as a substitute for necessary supervision of fall-prone residents, with entirely predictable results. Residents fell again and again at Petitioner's facility despite the fact that they had been provided with alarms. In some instances staff did not respond quickly enough to the sounds of alarms to provide adequate protection to residents. In other instances alarms failed to operate.

Resident # 9 fell many times despite the fact that Petitioner had supplied him with both a bed and a wheelchair alarm. CMS Ex. 25, at 28-102. These falls are graphic evidence of the inefficacy of Petitioner's reliance on alarms. I infer from these repeated falls that, not only was the use of alarms in this resident's case an ineffective form of assistance, but that it did not substitute at all for what might have been effective, adequate supervision.

The resident fell frequently when Petitioner's staff was not present to help him. Id. at 28, 36, 39, 42, 45, 64, 68, 71, 75, 78, 82, 94. Just prior to some of these falls the resident triggered his alarm and the staff heard it but was unable to respond with sufficient promptness to protect the resident from falling. Id. at 36, 39, 42, 78.

Similarly, Resident # 3 fell many times despite the staff's reliance on bed and chair alarms as assistance devices. I infer in the case of Resident # 3, as I do with Resident #9, that the resident fell often despite the use of alarms because of a lack of close supervision of the resident by Petitioner's staff. On numerous occasions Petitioner's staff discovered the resident only after he had fallen. CMS Ex. 19, at 27, 30, 40, 43, 49, 53, 56, 67, 71, 74, 78. In at least four of these events the staff responded to the sound of the resident's alarm but arrived too late to assist the resident. Id. at 43, 56, 67, 71.

What is particularly striking about the falls experienced by these residents is that Petitioner's staff knew or should have known after the first few falls that the residents sustained that alarms provided the residents with ineffective protection. The falls that these residents sustained were not isolated episodes. They were entirely predictable in that they followed a pattern that was well known to Petitioner's staff. That pattern included numerous falls by these residents when they were out of the staff's eyesight. Despite that, the staff acted as if supplying these residents with bed and chair alarms relieved it of its responsibility to supervise these residents closely in order to assure that they did not fall. As CMS notes, Petitioner's staff failed even to implement obvious protective measures such as moving the residents to rooms that were directly adjacent to Petitioner's nurses' station.

Petitioner argues that one may not infer that it supervised its residents laxly from evidence addressing specific falls because its overall rate of falls sustained by its residents was better than average fall rates sustained in skilled nursing facilities. I find this argument to be without merit. Statistics comparing Petitioner's total number of falls against those generated by other facilities cannot mask the reality - as is shown by the evidence pertaining to specific residents - of Petitioner's misplaced reliance on alarms in lieu of necessary supervision of fall-prone residents. Moreover, it is false logic to assume that Petitioner acted appropriately simply because other facilities may have had fall rates that were higher than that of Petitioner's facility. That is because there is no evidence in the record showing how other facilities protected or failed to protect their residents against falls.

The evidence also shows that Petitioner's alarms - inadequate substitutes for supervision as they were - either did not always function correctly or were not operating at all when residents fell. That made the safety of Petitioner's residents even more precarious. Three of the falls sustained by Resident # 9 occurred without triggering alarms that were in place at the time. CMS Ex. 25, at 32, 51; CMS Ex. 50, at 9. ⁽³⁾ On another occasion the resident fell while an alarm was in place, but the alarm did not sound because it had not been turned on. CMS Ex. 25, at 65. Resident # 3 sustained a fall in which his alarm failed to function correctly. CMS Ex. 19, at 58. Resident # 22 sustained three falls in which the resident's alarm failed to function. CMS Ex. 35, at 9, 12, 16. The resident sustained a fractured hip as a consequence of the third fall. Id. at 16, 30, 33, 79. Resident # 17 also sustained a hip fracture as a result of a fall in which her alarm did not function. CMS Ex. 30, at 7, 18, 20, 25.

Petitioner argues that it followed the appropriate standard of care for checking residents' alarms, checking them at least once per shift. Petitioner's pre-hearing brief at 33. In effect, Petitioner argues that it did all that it reasonably could be expected to do to assure that its residents' alarms were in working condition. I do not find this argument to be persuasive.

The issue, as I see it, is not whether Petitioner's staff performed adequate checks and maintenance of alarms. Alarms, as Petitioner concedes, are inherently unreliable equipment even when perfectly maintained. Petitioner's pre-hearing brief at 33. Petitioner relied on these devices in lieu of supervising residents closely when its staff knew or should have known that residents could not be protected adequately by alarms even if they functioned perfectly every time. The fact that they malfunctioned often simply made it more obvious that alarms were no substitute for close supervision of fall-prone residents.

3. Petitioner did not prove to be clearly erroneous CMS's determination that Petitioner's deficiencies were at the immediate jeopardy level of noncompliance.

An "immediate jeopardy" level deficiency is one which results in, or is likely to cause, serious injury, harm, or death to a resident. 42 C.F.R. � 488.301. The burden is on the facility to prove that CMS's determination of immediate jeopardy is clearly erroneous if a deficiency is shown to be present and CMS has determined that immediate jeopardy exists. 42 C.F.R. � 498.60(c)(2).

There is ample evidence in this case to support CMS's determination that Petitioner's failures to comply with the requirements of 42 C.F.R. �� 483.20(k)(3)(i) and 483.25(h)(2) were immediate jeopardy level deficiencies. Residents of Petitioner's facility sustained serious injuries from falls, including fractured hips on more than one occasion, that might have been prevented had Petitioner's staff assessed these residents thoroughly for their fall risks, planned their care accordingly, and implemented individualized care plans for the residents that gave them the close supervision that they needed. The evidence makes it evident, also, that residents of Petitioner's facility were likely to continue to sustain serious injuries, harm, or even death as a consequence of Petitioner's failure to assess residents for falls, to plan their care, and to supervise residents adequately. Residents at Petitioner's facility fell over and over again without Petitioner meaningfully increasing the supervision that these residents received. It was only a matter of time before residents would be seriously injured or worse as a consequence of Petitioner's lax supervision. The likelihood of injury existed for every resident who was poorly supervised as is shown by the injuries actually sustained by some of Petitioner's residents.

Petitioner has not offered credible evidence to show CMS's determination of immediate jeopardy to be clearly erroneous. Petitioner argues, essentially, that there is no evidence in this case supporting a conclusion that a likelihood existed that residents would be seriously injured, harmed, or die as a consequence of Petitioner's noncompliance. Petitioner's supplemental brief at 8. I disagree with that assertion. As I discuss above, there is evidence that residents of Petitioner's facility actually were injured seriously by Petitioner's noncompliance. That, alone, is sufficient to support CMS's determination. But, beyond that, one would have every reason to conclude, given the persistent failures by Petitioner's staff to assess comprehensively residents for fall risks and to supervise adequately fall-prone residents, that other serious injuries or worse consequences resulting from falls were only a matter of time at Petitioner's facility so long as its noncompliance persisted.

CMS determined that Petitioner's noncompliance persisted from March 11 through March 14, 2005, at the immediate jeopardy level and continued thereafter, albeit at a level that is less than immediate jeopardy, through April 18, 2005. Petitioner has not argued that, if it was deficient at the immediate jeopardy level, it eliminated immediate jeopardy prior to March 14, 2005. Furthermore, Petitioner has not disputed that it was deficient, at the non-immediate jeopardy level of noncompliance, through April 18, 2005. ⁽⁴⁾ Therefore, I sustain CMS's findings as to duration of immediate jeopardy and non-immediate jeopardy level deficiencies.

5. CMS's determination of civil money penalties amounts is reasonable.

CMS determined to impose civil money penalties consisting of: $6,000 per day for each day of the period beginning on March 11 and running through March 14, 2005, the period when Petitioner was deficient at the immediate jeopardy level; and $100 per day for each day of the period beginning on March 15 and running through April 18, 2005, after which Petitioner was in compliance with participation requirements. I find these civil money penalties to be reasonable.

What may be reasonable as a civil money penalty is governed by regulations. The regulations provide that penalties of from $3,050 - $10,000 per day may be imposed for immediate jeopardy level deficiencies. 42 C.F.R. � 488.438(a)(1)(i). Penalties ranging from $50 - $3,000 per day may be imposed for non-immediate jeopardy level deficiencies. 42 C.F.R. � 488.438(a)(1)(ii). What may be reasonable within a given penalty range depends on the evidence as it relates to factors for determining penalty amounts set out at 42 C.F.R. �� 488.438(f)(1) - (4), and 488.404 (incorporated by reference into 42 C.F.R. � 488.438(f)(3)). These factors include: the seriousness of a facility's deficiencies; the relationship between deficiencies; a facility's compliance history; its culpability for any deficiency; and its financial condition. Id. I apply these factors to the evidence in this case to decide whether CMS's penalty determinations are reasonable.

a. CMS's determination to impose penalties of $6,000 per day for each day of the March 11-14, 2005 period is reasonable.

The seriousness of Petitioner's two immediate jeopardy level deficiencies as well as its culpability for those deficiencies provides strong support for the $6,000 per day penalties that CMS determined to impose for each day of the March 11-14, 2005 period. First, the deficiencies were very serious. The failures of Petitioner adequately to assess its residents for fall risks, to plan its residents' care, and to supervise residents who were at extreme risk for injuries from falls, led at least indirectly to several residents falling and being injured. In some cases these injuries were severe.

Second, Petitioner's culpability for its deficiencies was high. Petitioner's staff had to know that the interventions that it developed for its residents were not working. It also had to know that these interventions failed precisely because they were no substitute for the close supervision that Petitioner's fall-prone residents needed. But, despite that certain knowledge, Petitioner's staff failed to take the necessary step of providing these residents with close supervision.

Petitioner's improper care of these residents extended over a lengthy period of time - months at least - and betrayed a systemic inability on Petitioner's part to cope with the residents' needs. Some of Petitioner's residents fell over and over again and yet, Petitioner's staff failed even to consider that these residents were falling due to lax supervision. In lieu of providing the residents with needed supervision the staff continued to rely on alarms that were palpably inadequate to protect the residents. In light of this, civil money penalties of $6,000 per day - which after all, fall only in the mid-range of what might be imposed for an immediate jeopardy level deficiency - are quite reasonable.

CMS urges also that I consider Petitioner's compliance history (Petitioner was found deficient at the non-immediate jeopardy level in surveys that took place in 2004 and 2003) as a reason for sustaining the $6,000 per day penalties. ⁽⁵⁾ However, I do not find Petitioner's compliance history to be a necessary factor in sustaining the penalties that CMS decided to impose. The seriousness of Petitioner's deficiencies, coupled with its culpability for them, is sufficient to justify penalties of $6,000 per day.

Petitioner has not offered evidence that supports reducing the penalty amount. Throughout this case Petitioner has argued that it was, in reality, extremely pro-active in addressing the needs of its fall-prone residents. For example, Petitioner contends that it investigated every fall sustained by each of its residents, prepared reports concerning those falls, and convened interdisciplinary meetings to discuss them. I have discussed why I believe that these efforts did not show Petitioner to be compliant with participation requirements and I do not need to revisit that issue here. However, in deciding the seriousness of Petitioner's noncompliance and its culpability I have taken into consideration those measures that Petitioner took on its residents' behalf. I conclude that the various measures it took, including the interventions that it made on behalf of some of its residents, do not counterbalance Petitioner's systemic failures to assess its residents for fall risks or to provide its residents with necessary supervision. Nor do they excuse Petitioner's consistent failure to consider providing residents with close supervision in the face of overwhelming evidence that increased supervision was necessary.

b. CMS's determination to impose civil penalties of $100 per day for each day of the March 15 - April 18, 2005 period is reasonable.

The $100 per day civil money penalties that CMS determined to impose against Petitioner for each day of the March 15 - April 18, 2005 period of noncompliance are close to the minimum civil money penalty amount. Petitioner has offered no evidence to show that penalties of this amount are unreasonable and I sustain them.

Steven T. Kessel

Administrative Law Judge

1. Petitioner contends also that CMS did not offer qualified expert testimony to establish the relevant standard of care or to show that Petitioner's care was deficient. Petitioner's reply brief at 1. That assertion is incorrect. CMS offered testimony of surveyors who are well-qualified to establish the applicable standard of care. CMS Ex. 48; CMS Ex. 49; CMS Ex. 50. For example, CMS relied on the testimony of Ms. Lori Thyssen to establish the applicable standard of care. CMS Ex. 48, at 2. Ms. Thyssen, aside from being a registered nurse and a former charge nurse, has served as a safety manager at a long-term care facility. Id. at 1; CMS Ex. 45. I find Ms. Thyssen to be well-qualified and her opinion to be persuasive.

2. I take notice that a taco mattress is a mattress with edges that are higher than the center. It is designed to prevent the individual who uses it from rolling out of bed while unattended.

3. One of these falls was observed by a surveyor. On March 10, 2005, a surveyor observed Resident # 9 fall from his wheelchair. CMS Ex. 50, at 9. At the time, the resident's chair was equipped with a pad alarm (pressure sensitive alarm). The surveyor observed the resident slumped over in his chair with his head on his knees. The resident slid forward, falling out of the chair. The alarm did not sound until the resident hit the floor. In the opinion of the surveyor, the staff would have been given some extra time to assist the resident had the resident been wearing a clip alarm (an alarm that is attached to the resident's body with a cord and which sounds when the resident's posture changes sufficiently to detach the cord). Id.

4. Petitioner's noncompliance after March 14 included those non-immediate jeopardy level deficiencies that were substantial, but which Petitioner did not challenge.

5. Neither CMS nor Petitioner contend that Petitioner's financial condition should have a bearing on the penalty amounts.