SUBJECT:

Life Care Center of Gwinnett,

Petitioner,

Centers for Medicare & Medicaid Services

DECISION

I sustain the determination of the Centers for Medicare & Medicaid Services (CMS) to impose civil money penalties of $400 per day against Petitioner, Life Care Center of Gwinnett, for each day of a period that began on April 28, 2004 and which ran through May 9, 2004.

I. Background

Petitioner is a skilled nursing facility in Lawrenceville, Georgia, in the Atlanta, Georgia metropolitan area. It participates in the Medicare program. Its participation in Medicare is subject to the requirements of sections 1819 and 1866 of the Social Security Act and to implementing regulations at 42 C.F.R. Parts 483 and 488.

On April 28, 2004, Petitioner was surveyed to determine whether it was complying with Medicare participation requirements (April survey). The surveyors concluded that Petitioner was deficient in several respects. Most notably, the surveyors concluded that Petitioner was not complying with participation requirements stated at 42 C.F.R. �� 483.13(c)(1)(i); 483.20(k)(3)(i); and 483.25(h)(2). CMS ultimately accepted these findings and determined to impose civil money penalties against Petitioner of $400 per day for a period which ran from April 28 through May 9, 2004. ⁽¹⁾

Petitioner requested a hearing and the case was assigned to me for a hearing and a decision. I held a hearing in Atlanta, Georgia on September 1, 2005 at which the parties offered exhibits and testimony. I received into evidence from CMS the following exhibits: CMS Ex. 1 - CMS Ex. 32. I received into evidence from Petitioner the following exhibits: P. Ex. 1 - P. Ex. 21 and P. Ex. 23 - P. Ex. 24.

II. Issues, findings of fact and conclusions of law

A. Issues

The issues in this case are whether:

1. Petitioner received adequate notice of CMS's allegations of noncompliance;

2. Petitioner failed to comply substantially with one or more Medicare participation requirements during the April 28 - May 9, 2004 period; and

3. Civil money penalties of $400 per day or some other amount are reasonable remedies for any noncompliance by Petitioner during the April 28 - May 9, 2004 period.

B. Findings of fact and conclusions of law

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

1. Petitioner received adequate notice of CMS's allegations of noncompliance.

Petitioner argues that CMS's current noncompliance allegations are expanded significantly from that which was alleged in the report of the April survey. See CMS Ex. 1. Petitioner contends that it would be denied due process if it is now held accountable for allegations that were not contained in the survey report.

I find this argument to be unpersuasive. Although Petitioner is correct in asserting that CMS now states its noncompliance allegations more expansively than that which surveyors alleged in the April survey report, Petitioner received these expanded allegations months in advance of the September 1, 2005 hearing and had ample opportunity to reply to them.

The noncompliance allegations of the April survey report focus closely on an event that occurred on March 4, 2004. On that date, a resident who is identified in the survey report as Resident # 1 fell in a bathroom in Petitioner's facility. The resident sustained serious injuries from her fall. The survey report asserts primarily, but not exclusively, that Petitioner's noncompliance lay in the way that nursing staff responded to the resident's cries of distress on March 4, 2004, moments before she fell.

CMS filed a pre-hearing brief and all of its proposed evidence, including its proposed exhibits and written direct witness testimony on November 26, 2004, pursuant to a pre-hearing order that I issued in this case. In its brief, CMS expanded its allegations of noncompliance concerning the care that Petitioner gave to Resident # 1.

Specifically, CMS alleged that:

� Petitioner failed to develop an appropriate and accurate care plan for Resident # 1 that addressed her risk of falling. CMS pre-hearing brief at 1 - 3.

� Petitioner made incomplete and inaccurate fall risk assessments of Resident # 1. Id. at 2.

� Petitioner inappropriately discontinued the use of a tab alarm for Resident # 1 even though the resident remained at significant risk for falls. Id. at 4.

� Petitioner failed to replace the discontinued tab alarm with some other device or service that was designed to protect the resident against falling. Id.

� The toileting plan that Petitioner developed for Resident # 1 was inadequate because it did not envision sufficiently frequent trips to the bathroom. Id. at 4 - 5.

� Petitioner failed to toilet Resident # 1 on a regular basis. Id. at 5.

CMS's November 26, 2004 filing gave Petitioner notice not only of CMS's expanded arguments, but of all of its evidence as well. Petitioner had ample time to prepare defenses to these arguments and evidence. I gave Petitioner a full month to obtain evidence and to make arguments in response to CMS's allegations and evidence. Petitioner did not argue that I gave it insufficient time in which to frame its defenses.

Petitioner argues that, as a matter of law, CMS's remedy determination must be based exclusively on the specific findings that are made at a survey. Petitioner's post-hearing brief at 3; see 42 C.F.R. � 488.402(b). Petitioner's argument, essentially, is that a survey report must be treated as a non-amendable administrative pleading.

This argument is not supported by applicable regulations or by practice in cases before the Departmental Appeals Board. The regulation cited by Petitioner does not rigidly limit CMS's allegations to the literal wording of a survey report. Rather, the regulation requires that a remedy determination be based on survey findings. The regulation does not state that the findings must be encompassed entirely within a survey report, nor does it limit CMS to imposing remedies based exclusively on the contents of a survey report. There is nothing in the regulation which precludes CMS from basing its remedy determination on surveyors' findings in circumstances where the survey report does not state the findings completely. Indeed, regulations governing hearings in cases involving CMS expressly contemplate that issues may arise in a case that are not stated explicitly in an initial determination or, by extension, a survey report. 42 C.F.R. � 498.56.

Of course, there are due process implications when survey findings are not fully disclosed in a survey report. A facility should not be required to defend against allegations of which it has no advance notice. But, CMS is not limited by the narrow words of a survey report so long as it gives a facility adequate and timely notice of what it is alleging. Here, CMS gave Petitioner notice of its expanded allegations in November 2004, more than nine months before the date of the hearing and Petitioner had ample time to respond to them. In doing so, CMS complied with my pre-hearing order in this case which contemplates the possibility that either party - CMS or Petitioner - might expand its allegations after developing its case. The order gives each party the opportunity to, in effect, amend its initial allegations so long as it gives reasonable notice to its adversary.

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

The regulation at issue obligates a nursing facility to ensure that each of its residents receives adequate supervision and assistance devices to prevent accidents. The regulation has been the subject of much litigation in cases before the Departmental Appeals Board. While it does not impose strict liability standards on a facility it does require that a facility do all that is within reason to protect its residents against sustaining accidents. A facility is, therefore, not liable per se for every accident that a resident might sustain. But, it is obligated to identify all possible hazards that a resident might encounter and to take all reasonable measures that are within its power to implement in order to protect a resident or residents against sustaining accidents.

Here, CMS alleges that Petitioner failed to meet its obligations to protect Resident # 1 against sustaining accidents. More specifically, CMS alleges that Petitioner knew that Resident # 1 was at known risk for falling due to her various medical conditions and their consequences for the resident. Yet, according to CMS, Petitioner failed to do all that it reasonably should have done to supervise the resident or otherwise protect her.

Many of the facts that address the resident's condition and the care that she received are not disputed. Resident # 1 was 85 years old as of her fall. CMS Ex. 4, at 1. The resident suffered from a number of physical and mental impairments. These included severe osteoporosis, diabetes, glaucoma, and dementia. CMS Ex. 5, at 1 - 11. The resident's impairments limited her in many ways. She had severely limited mobility. Resident # 1 was confined to a wheelchair much of the time. She required extensive assistance from Petitioner's staff with bed mobility, transfers, dressing, toileting, hygiene, and bathing. P. Ex. 10, at 20; CMS Ex. 4, at 2 - 3.

The resident was at risk for spontaneous fractures as a consequence of her osteoporosis. CMS Ex. 5, at 3. She was at a risk for injury as a result of her vision problems. Id., at 8. She was at risk for increased confusion secondary to her dementia. Id., at 6. The resident was assessed as having a short-term memory problem. CMS Ex. 4, at 2. Resident # 1 experienced occasional problems with bowel and bladder incontinence. CMS Ex. 5, at 10.

Occasionally, Resident # 1 would attempt to toilet herself. However, Petitioner's staff assessed the resident as needing extensive assistance by staff in performing this task. CMS Ex. 4, at 2 - 3. The staff recognized that, in attempting to toilet herself, Resident # 1 was at risk for falling as a consequence of her impairments and the associated limitations. The resident fell at least twice prior to the March 4, 2004 incident, on November 22, 2002 and again, on December 11, 2002. Both episodes occurred when the resident attempted to toilet herself. CMS Ex. 5, at 9. Resident # 1 sustained injuries as a consequence of the November 2002 fall including compression fractures of her vertebrae. CMS Ex. 5, at 3.

The resident's care plan listed interventions by Petitioner's staff that were intended to protect the resident from falling. CMS Ex. 5, at 9. These included:

� Enrolling the resident in Petitioner's falling stars program, which consisted of putting a star on the resident's room door to remind staff of the resident's fall risk;

� Assisting the resident back into her wheelchair when she was observed attempting to stand;

� Assisting the resident back into bed if she was observed attempting to climb out of bed;

� Observing the resident and assisting the resident when she engaged in risky behavior until the fall risk was no longer present;

� Reporting incidents of the resident being at risk to the facility's charge nurse;

� Frequently reminding the resident to use her call light to request assistance for transfers;

� Beginning on December 12, 2003, using a tab alarm while the resident was in a wheelchair; and

� Having the resident wear fall guards at all times.

Id.

On April 17, 2003 Petitioner discontinued applying fall guards to Resident # 1. Id. Petitioner asserts - and CMS does not dispute it - that the fall guards were discontinued at the resident's request or the request of the resident's family. Petitioner also discontinued using the tab alarm on January 10, 2004. Id. The resident's treatment records in evidence provide no explanation for the decision to discontinue using the tab alarm. ⁽²⁾

A tab alarm includes a cord that is attached to a resident's clothing at one end and at the other end to a box that is affixed to the resident's wheelchair. If a resident who wears a tab alarm attempts to rise from the chair the cord will be disconnected from its socket and will trigger a loud alarm. The purpose of a tab alarm is to alert a facility's staff to potentially hazardous activity by a resident. In this case, obviously, the purpose of the alarm was to alert Petitioner's staff to any attempt to rise from her wheelchair without assistance. I find that the staff considered the need for an alarm to be important when it first began using the device in the case of Resident # 1. The resident had fallen the day before the alarm was implemented after getting out of her wheelchair and attempting to toilet herself. It is fair to infer that the decision to use the alarm was in direct response to that incident and the similar fall that the resident had sustained the previous month.

Although there is little or no dispute about the above stated facts, there is considerable dispute about what happened on March 4, 2004, when Resident # 1 sustained her final fall. CMS contends that Petitioner's staff was remiss in the manner in which it responded to the resident's cries. Petitioner contends that the resident's fall occurred despite the best efforts of the staff to protect the resident.

I am satisfied from the weight of the evidence that the immediate response by Petitioner's staff to Resident # 1's predicament on March 4, 2004 was appropriate. The facts establish that the staff responded swiftly to the resident's cries of distress, that they attempted appropriately to prevent the resident from falling, and that the resident fell despite the staff's best efforts at the moment. However, and as I explain below, those efforts do not excuse Petitioner from other lapses in care that put the resident at risk for falling. It is these other lapses that are the basis for my findings of noncompliance with the requirements of 42 C.F.R. � 483.25(h)(2).

The evidence establishes that, on the afternoon of March 4, 2004, staff members heard cries emanating from Resident # 1's room. Three members of Petitioner's staff responded by rushing to the room. There, they observed Resident # 1 standing in her bathroom, holding onto a safety bar that was on the wall adjacent to the toilet. The resident, her clothing, and the floor of the bathroom were covered with feces. It is reasonable to infer that the resident had experienced an episode of incontinence and had attempted to toilet herself. The resident was able to get out of the wheelchair and ambulate sufficiently to get into her bathroom. Once there, she was unable to lower herself to the toilet and found herself in the precarious position of standing while holding on to the safety bar.

The resident fell within seconds of being observed. CMS contends that the staff failed to protect the resident because, allegedly, no member of the staff entered the bathroom immediately in order to stabilize and assist the resident. Instead, according to CMS, each of the three staff members delayed assisting the resident while they put on protective gloves.

Petitioner's version of what happened immediately after the staff observed the resident is quite different. Petitioner contends that one of the staff - Kim Merritt, a nurse - entered the bathroom without hesitating upon observing the resident and attempted to support her. However, the resident lost her grip despite Ms. Merritt's best efforts, and in doing so, twisted away from Ms. Merritt and fell. In Petitioner's account of events the resident fell almost instantly after Ms. Merritt placed her hand on the resident's shoulder.

In her testimony, Ms. Merritt averred that she did not pause to put on gloves before attempting to assist the resident. Tr. at 173 - 174. There is a discrepancy between this testimony and one of the two statements that Ms. Merritt signed shortly after the events of March 4, 2004. P. Ex. 15, at 1. In her previous statement, Ms. Merritt averred that she and her colleagues put on gloves before attempting to assist the resident. Id. However, I am persuaded by Ms. Merritt's testimony at the hearing that she went to Resident # 1's aid without hesitation and without first putting on gloves. I am also persuaded that the resident fell despite Ms. Merritt's best efforts to stabilize her. In light of that, I find that there was nothing more within reason that the staff could have done to protect the resident after they responded to her cries for help.

However, the staff's immediate response to the resident's predicament on March 4, 2004 does not excuse or condone the way Petitioner dealt with the resident's problems in the months preceding that date. I conclude that Petitioner failed to protect the resident from getting into the predicament that she was in on March 4, 2004.

The actions of Petitioner's staff on March 4, 2004 are not essential to my finding that Petitioner failed to comply substantially with the requirements of 42 C.F.R. � 483.25(h)(2). That the staff acted appropriately when it found the resident in distress on March 4 excuses Petitioner from liability for the staff's conduct on that date. But, that does not excuse Petitioner from liability for the omissions of care that were the cause of the March 4 incident. Indeed, I would conclude that Petitioner failed to comply with the requirements of the regulation even if the March 4 incident had never occurred. Petitioner's deficiency lies in its failure to protect the resident from the possibility of harm resulting from a fall. The incident that occurred on March 4, 2004 is a predictable consequence of that deficiency, but is not necessary to conclude that Petitioner did not protect the resident adequately.

Petitioner knew that the resident was at risk for falling. The resident was wheelchair bound due to her infirmities and impairments. But, she was also capable of rising to her feet. She was at great risk for falling and injury whenever she attempted to do so away from the presence and assistance of Petitioner's staff. The resident suffered from dementia from which I infer that she was not necessarily aware of the risks posed to her safety that resulted from her attempts to stand unassisted. The resident had vision problems which made it more difficult for her to see and to anticipate hazards.

Petitioner's staff knew, or should have known, that when the resident attempted to toilet herself, her unsteadiness, along with her vision impairment and her dementia, put her at great risk for injury. The resident was known to attempt to toilet herself despite her impairments and infirmities. Twice, prior to March 4, 2004, the resident had fallen while attempting to do so. On one of those occasions she had sustained serious injuries.

Leaving the resident in circumstances where she might attempt to stand unassisted was unacceptable given what Petitioner's staff knew or should have known about the resident's infirmities and proclivities. A prudent staff would have undertaken every reasonable effort to make as certain as possible that the resident did not attempt to stand unassisted, particularly when attempting to use the toilet.

The efforts that Petitioner undertook to protect the resident fell short of exhausting that which was reasonable. In particular, Petitioner left the resident vulnerable by removing the tab alarm from the resident's wheelchair and by not substituting some other equally effective method of surveillance for the alarm.

Petitioner's decision on January 10, 2004 to remove the resident's tab alarm is inexplicable in light of the known risks posed by the resident's attempts to toilet herself. As I discuss above, there is no assessment in the resident's record that supports removal of the alarm. Petitioner now asserts that the resident's condition had improved so that the alarm could be removed. But, I find nothing in the resident's clinical record that supports this contention. The medical conditions which put the resident at risk and in need of supervision and assistance when attempting to stand or to use the toilet had not improved. Petitioner's staff did not assess the resident in January 2004 as being less at risk for falls than previously.

The fact that no falls were documented between December 2002 and March 2004 was no reason for Petitioner to eliminate the precautions that it put in place after the December 2002 fall. The lapse in time between serious falls was not a basis for Petitioner to discontinue the safety precautions that it had put into place. The resident's physical condition had not improved an iota during the period and there was no assessment made of the resident that concluded that the resident was no longer interested in, or capable of, toileting herself.

Petitioner argues, alternatively, that the alarm might have been removed at the resident's request. Petitioner notes that the alarm created a shrill, highly annoying noise when it was triggered and that might have prompted the resident to demand its removal. Again, this argument is not supported by the resident's clinical record. But, assuming it to be true, it does not justify Petitioner removing the alarm but failing to implement some other, equally effective, system of surveillance.

Petitioner asserts that it would have violated the resident's dignity to continue using the alarm once the resident complained about the noise it created. Obviously, a facility should attempt to accommodate a resident's desires and to respect that resident's dignity. But a facility cannot justify exposing a resident to the risk of injury or worse by asserting that it was attempting to protect the resident's dignity. If the resident was offended by the alarm and Petitioner's staff found it appropriate to remove it, that action imposed on Petitioner the duty to come up with some alternative, equally effective way of protecting the resident.

At the hearing Ms. Merritt testified that the staff discontinued the tab alarm:

because . . . [Resident # 1] hadn't had a fall in over a year, and she didn't like it, so they weighed the consequences, and we felt like she could benefit from not having it. It made her agitated. She didn't want to wear it. She hadn't had a fall. We felt she was safe enough to where we could take the alarm off.

Tr. at 155.

This assertion that Petitioner's staff weighed the benefits and liabilities of removing the tab alarm is a self-serving rationalization, made after the fact. The record is devoid of evidence to show that the staff did the "weighing" that Ms. Merritt asserts was done. The resident's care plan merely states, without explanation, that the tab alarm was discontinued. CMS Ex. 5, at 9.

But, the staff's logic was patently flawed if, in fact, it actually weighed the pros and cons of removing the tab alarm and decided to do so without providing some other equally protective measure in its place. Petitioner's arguments to the contrary, the clinical record supports the conclusion that the resident was at as great a risk for falling after the tab alarm was removed as she was previously, when she wore the alarm. The staff was faced with an obvious problem: this resident had a known proclivity for attempting to toilet herself outside the presence of facility staff despite physical and mental problems that made such an act dangerous to the resident. How was the staff going to take all reasonable measures to assure that the resident would not engage in such attempts?

Given that, the staff should have developed alternative and equally effective mechanisms for protecting the resident after they removed the alarm. In the absence of an alarm, the staff should have, at the least, kept the resident under closer observation. ⁽³⁾ Additionally, the staff might have implemented rigorously a toileting schedule for the resident that eliminated the possibility that the resident would attempt to toilet herself while unsupervised. ⁽⁴⁾ But, the staff failed to implement - and judging from the resident's records, failed to consider implementing - such measures. In effect, removing the alarm put the resident at the same risk for injury as was present prior to her first documented fall while toileting herself in November 2002. Simply putting the resident back in those circumstances was unacceptable.

3. It is unnecessary that I address CMS's additional allegations of noncompliance.

CMS alleges that, in addition to not complying with the requirements of 42 C.F.R. � 483.25(h)(2), Petitioner failed also to comply substantially with the requirements of 42 C.F.R. � 483.13(c)(1)(i) and 42 C.F.R. � 483.20(k)(3)(i). The first of these two regulations mandates a facility to develop and implement written policies and procedures that prohibit mistreatment, neglect, and abuse of residents and misappropriation of residents' property. The second requires that a facility provide services to its residents that meet professional standards of quality.

CMS's assertions that Petitioner failed to comply with these two additional regulations rest essentially on the identical facts that are the basis for its contention, and my finding, that Petitioner failed to comply with the requirements of 42 C.F.R. � 483.25(h)(2). Essentially, CMS contends that Petitioner neglected Resident # 1's needs by not protecting her adequately against the possibility that she might fall. And, it contends that Petitioner failed to provide care that met professional standards of quality in that it failed to assess Resident # 1's needs adequately, to plan for those needs, and to implement its plans effectively, in order to protect the resident against falling.

Below, at Finding 4, I find that Petitioner's noncompliance with 42 C.F.R. � 483.25(h)(2) is, in and of itself, sufficient cause to justify the $400 per day civil money penalties that CMS determined to impose. Making findings about additional regulatory violations - based on the identical facts that justify the penalties - is unnecessary because it adds nothing to my decision as to the seriousness of Petitioner's noncompliance or as to the reasonableness of the remedy.

4. Civil money penalties of $400 per day are reasonable.

Regulations establish criteria that govern civil money penalty amounts in cases involving CMS and nursing facilities. The relevant factors may include the seriousness of any deficiency; a facility's compliance history; its culpability; the relationship of deficiencies to each other; and the facility's financial condition. 42 C.F.R. �� 488.438(f)(1) - (4); 488.404 (incorporated by reference into 42 C.F.R. � 488.438(f)(3)). Civil money penalties that are imposed to remedy a deficiency that is not at the immediate jeopardy level of scope and severity, as is the case here, must fall within a range of from $50 to $3,000 per day. 42 C.F.R. � 488.438(a)(1)(ii).

I find that civil money penalties of $400 per day are reasonable because they reflect the seriousness of Petitioner's noncompliance and the Petitioner's culpability. Neither party offered evidence relating to other applicable factors. For example, Petitioner did not contend that it lacks the wherewithal to pay the civil money penalties that CMS determined to impose. Nor has CMS argued that Petitioner's compliance history justifies the penalties.

These penalties - which are only 15 percent of the maximum permissible penalties for non-immediate jeopardy level deficiencies - are actually quite modest in view of the harm caused to Resident # 1. Petitioner's failure to provide adequate supervision and assistance for Resident # 1 clearly harmed her. The fact that the staff may have done all that they reasonably could do on March 4, 2004 to assist the resident when they found her in distress does not negate the fact that the resident would not have been in the predicament she found herself in had the staff adequately protected her. Had the tab alarm been in place, the staff would have had more time to respond when the resident got out of her wheelchair.

Petitioner is culpable for the harm caused to Resident # 1. It was within Petitioner's power to protect her from the possibility of falling. Petitioner's staff knew, or should have known, that the resident was uniquely vulnerable. The actions taken on the resident's behalf were manifestly inadequate and that should have been apparent to Petitioner's staff.

Petitioner argues that civil money penalties in this case would not have any remedial purpose. According to Petitioner: "As a practical matter, it is hard to see how imposition of . . . [civil money penalties] in the circumstance of this case would - or even - could motivate any nursing facility to prevent the sort of accident that occurred here." Petitioner's post-hearing brief at 29. I disagree with this analysis. The penalties in this case have an obvious remedial purpose of reminding facilities, especially Petitioner, that they need to devote careful attention to the needs of their residents and to provide these vulnerable individuals with the supervision and assistance they need to prevent accidents.

5. The duration of the penalties is not at issue.

CMS determined that Petitioner's noncompliance lasted through May 9, 2004. Petitioner has not asserted that it corrected its noncompliance prior to that date. Consequently, I find that CMS is authorized to impose civil money penalties of $400 per day against Petitioner for each day of the April 28 - May 9, 2004 period.

Steven T. Kessel

Administrative Law Judge

1. CMS determined to impose additional civil money penalties for a period that began to run on May 10, 2004, based on findings made at a survey that was completed on May 19, 2004. Petitioner did not challenge these additional penalties or the noncompliance findings that were the basis for them.

2. Below, I discuss Petitioner's contention that the staff found the alarm no longer to be necessary due to improvement in the resident's condition.

3. I hold only here that the level of supervision that the facility provided Resident

# 1 after it discontinued the alarm was inadequate. I make no findings as to how closely the facility should have supervised the resident after it discontinued the resident's alarm. For example, I do not find that the facility should have kept the resident under continuous observation. How much additional supervision would have been necessary depended on the resident's condition and an assessment that the facility did not make.

4. The resident's care plan did include a direction that the resident be toileted "before and after meals, at hs, upon rising in am and when awaken at night." P. Ex. 11, at 10. The note in the care plan does not explain the acronym "hs". I infer that it means "her suggestion." However, there is nothing in the record to show whether the staff evaluated the resident after discontinuing the tab alarm to determine whether this schedule was adequate or whether additional trips to the toilet might be necessary in light of the alarm's discontinuance. And, while there is some reference in nursing notes to staff's efforts to toilet the resident, there is nothing in the record of this case to show that Petitioner rigorously followed the schedule set out in the care plan. See CMS Ex. 10, at 1.