SUBJECT:

Wesley Nursing & Rehab. Center,

Petitioner,

Centers for Medicare & Medicaid Services.

DECISION

This case came before me pursuant to a request for hearing filed by Petitioner, Wesley Nursing and Rehabilitation Center on August 9, 2004, in accordance with sections 1819, 1919, 1128A(c)(2) of the Social Security Act (Act) and 42 C.F.R. �� 488.408(g) and 498.40.

Petitioner is a skilled nursing facility (SNF) participating in the Medicare/Medicaid programs. The North Carolina State Survey Agency (State Agency) completed a survey on May 6, 2004 concluding that Petitioner was not in substantial compliance with federal Medicare/Medicaid requirements for nursing home participants. As a result, the Centers for Medicare and Medicaid Services (CMS) imposed the following remedies.

� Civil Monetary Penalty (CMP) of $ 3,050 per day effective April 14, 2004 through May 5, 2004, when immediate jeopardy was determined to exist.

� CMP of $ 200 per day effective May 6, 2004, when the immediate jeopardy was abated, and continuing until the facility achieved substantial compliance or terminated.

� Denial of Payment for New Admissions (DPNA) effective August 6, 2004.

� Mandatory termination effective November 6, 2004.

At the hearing, CMS stated that the only remedy it is pursuing here is the immediate jeopardy CMP of $3,050 from April 14, 2004 until May 5, 2004. Transcript (Tr.) 8-9.

I held a hearing in Charlotte, North Carolina on September 13 and 14, 2005. CMS offered 7 proposed exhibits identified as CMS Exhibits (CMS Exs.) 1 and 3-8. CMS's proposed exhibits were admitted without objection. Petitioner offered 47 proposed exhibits. These were admitted into the record as Petitioner's Exhibits (P. Exs.) 1-47, without objection. Petitioner submitted a post hearing brief (P. Br.) and reply brief, and CMS submitted a post hearing brief (CMS Br.) and reply brief.

Based on the testimony offered at the hearing, the documentary evidence, the arguments of the parties, and the applicable law and regulations, I find that from April 14, 2004 through April 29, 2004, Petitioner was in substantial compliance with Medicare participation requirements. I further find that Petitioner was not in substantial compliance at the immediate jeopardy level from April 30, 2004, until May 5, 2004. Consequently, CMS is authorized to impose against Petitioner, a CMP at the rate of $3,050 per day for that period of non-compliance.

I. Applicable Law and Regulations

Petitioner is a long-term care facility under the Act and regulations promulgated by the Secretary of Health and Human Services (Secretary). The statutory requirements for participation by a long-term care facility are found at sections 1819 and 1919 of the Act and at 42 C.F.R. Part 483.

Sections 1819 and 1919 of the Act invest the Secretary with authority to impose remedies against a long-term care facility for failure to comply substantially with participation requirements.

Pursuant to the Act, the Secretary has delegated to CMS and the States the authority to impose remedies against a long-term care facility that is not complying substantially with federal participation requirements. The applicable regulations at 42 C.F.R. Part 488 provides that facilities which participate in Medicare may be surveyed on behalf of CMS by State survey agencies in order to ascertain whether the facilities are complying with participation requirements. 42 C.F.R. �� 488.10-488.28.

The regulations contain special survey conditions for long-term care facilities. 42 C.F.R. �� 488.300-488.335. Under Part 488, a state or CMS may impose remedies against a long-term care facility where a state survey agency ascertains that the facility is not complying substantially with participation requirements. 42 C.F.R. �� 488.406, 488.408 and 488.430. The penalty may start accruing as early as the date that the facility was first out of compliance until the date substantial compliance is achieved or the provider agreement is terminated. 42 C.F.R. 488.440.

The regulations define the term "substantial compliance" to mean:

. . . a level of compliance with the requirements of participation such that any identified deficiencies pose no greater risk to resident health or safety than the potential for causing minimal harm.

42 C.F.R.� 488.301.

Immediate jeopardy" is defined to mean:

A situation in which the provider's noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident.

Id.

Remedies by CMS are appropriate only after CMS makes a prima facie showing that the facility has failed to comply substantially with participation requirements. To prevail, a long-term care facility must overcome CMS's showing by a preponderance of the evidence. Hillman Rehabilitation Center, DAB No. 1611 (1997), aff'd, Hillman Rehabilitation Center v. HHS, No. 98-3789 (D.N.J. May 13, 1999).

The Act and regulations make a hearing before an administrative law judge (ALJ) available to a long-term facility against whom CMS has determined to impose a remedy. Act, � 1128A(c)(2); 42 C.F.R. �� 488.408(g) and 498.3(b)(12), (13). The hearing before an ALJ is a de novo proceeding. Anesthesiologists Affiliated, DAB CR65 (1990), aff'd, 941 F.2d 678 (8th Cir. 1991).

II. Issues

1. Whether the facility was complying substantially with federal participation requirements on the dates CMS determined to impose remedies.

2. Whether CMS's determination of immediate jeopardy was clearly erroneous.

3. Whether there is a basis for the imposition of remedies against Petitioner.

III. Findings and Discussion

The findings of fact and conclusions of law noted below in italics are followed by a discussion of each finding.

1. The facility failed to provide adequate supervision of resident number 2 (R2), and failed to do what was reasonably expected in order to prevent accidents as required by 42 C.F.R. � 483.25(h)(2).

2. The facility failed to implement policies and procedures that prohibit neglect and abuse of residents.

3. The facility was in substantial compliance from April 13, 2004 through April 29, 2004.

4. Petitioner was not in substantial compliance with federal participation requirements from April 30, 2004 until May 5, 2004.

CMS determined that Petitioner was in violation of 42 C.F.R. � 483.25(h) (2) and 42 C.F.R. � 483.13(c) (i).

42 C.F.R. � 483.25(h)(2) requires that a facility must ensure that each resident receives adequate supervision and assistance devices to prevent accidents.

42 C.F.R. � 483.13(c)(i) requires that a facility must develop and implement written policies and procedures that prohibit mistreatment, neglect, and abuse of residents and misappropriation of resident property.

State surveyor's findings for 42 C.F.R. � 483.25(h)(2) as reflected at Tags F224, 226, and 324 in the Statement of Deficiencies (CMS Ex. 1).

R2 was admitted to the facility on November 24, 2003 with diagnoses of cellulitis of the left shoulder, a history of seizures, anemia, cerebrovascular accidents, alcoholism, and depression. P. Ex. 7, at 4. New diagnoses added after admission included mental changes, and dementia. P. Ex. 11, at 1.

On January 14, 2004, at 10:30 p.m., R2 was observed in the hallway with a belt, stating that he was going to hit the person who was tearing up the kitchen. P. Ex. 1, at 3. After a three month hiatus, he was again seen wandering the hallways on April 14, 2004, in a combative mood, refusing medications, entering other residents' rooms, and slamming doors. Id.

On April 15, 2004, at 1:00 a.m., R2 was walking around with a belt and threatening to kill people. Id. At 12:30 a.m. on April 16, 2004, the resident was in and out of other residents' rooms, swinging a belt at staff and holding a razor with which he threatened to cut people. Id. That same day at 9:00 p.m. he was up and down the hallways, cursing and threatening staff, and swinging a hammer. Id. On these occasions security was called and a physician ordered Ativan (intramuscular). P. Ex. 1, at 4. The outbursts continued until April 17 at 12:40 a.m., when Ativan 1mg. was administered and the resident was put to bed. Id.

No combative behavior was noted until April 30, 2004, at 10:00 p.m. when R2 was observed to be upset and swinging a belt. P. Ex. 1, at 4. R2's family was contacted and he calmed down until May 2, 2004, when he became very upset and verbalized doing harm to staff and other residents. Id. The resident's family was called again, and he calmed down and went to bed after security sat with him awhile. P. Ex. 1, at 5.

On May 4, 2004, at 11:00 p.m., R2 entered other residents' rooms, trying to push and hit residents. P. Ex. 1, at 5. A security guard watched the resident until the physician was notified and orders given. Id. On May 5, 2004, R2 was very agitated, made verbal threats to kill, and refused to leave other residents' rooms. Id. He had a belt that he swung at staff and female residents. Id. Around 6:30 p.m., three staff members had to hold him down while intramuscular medication was administered, and in the process he kicked two CNAs. Id. Subsequently, an ambulance was called and he was transferred to the emergency room and eventually discharged from the facility P. Ex. 42, at 1.

Discussion

CMS contends that R2 displayed unruly conduct that progressively escalated, commencing April 13, 2004 and ending May 5, 2004, when he was finally discharged from the facility. Respondent breaks down that span of time into four distinct periods. According to CMS, during the first two of those four periods (from April 13 to April 19, 2004), the resident engaged in nightly or near nightly aggressive conduct. During the third period (from April 19, to April 29, 2004), R2's conduct appeared to be quiet at a time "when he continued to receive medications as he had historically". CMS Br., at 19. The fourth period (from April 30 to May 5, 2004), is a time when "the resident was quiet but his medications had been discontinued." ⁽¹⁾

CMS maintains that on April 13, 2004, the resident entered other residents' rooms, slammed doors, and refused medications. The following night he carried a belt and threatened to kill people, nevertheless neither the treating physician nor family were notified, and close monitoring was not ordered. CMS Br., at 2. CMS also asserts that no assessment was conducted to determine the root cause of R2's conduct or its effect on other residents. CMS further alleges that on the third night (April 15), the resident was carrying a belt buckle and a razor and making a fist in a threatening way. P. Ex. 1, at 3. Security was called to prevent the resident from injuring others. Again, states CMS, no call was made to the resident's physician, family, Director of Nursing (DON), administrator, social worker, pharmacy consultant, or psychological consultant. CMS Br., at 20.

Additionally, CMS argues that no order was given for close monitoring or for determining ways to protect other residents. Further, CMS adds that on the fourth night of the first period, the resident's behavior escalated and included threats with a paint scraper and a hammer, and entering a female resident's room, who became fearful of his threats. CMS posits that the sequence of events recited above demonstrates the failure on the part of the facility management to know what was happening inside its building, and a systemic and negligent failure on the part of the direct care and supervisory staff to review the day-to-day records and communicate incidents such as those referenced here, to those in charge of the facility. CMS adds that the facility's response of medicating the resident and providing assurances to the fearful female resident was insufficient to protect other residents. CMS Br., at 21-22.

Petitioner disagrees with CMS's assessment of the facility's response to R2's combative behavior. It is Petitioner's contention that its staff managed the resident appropriately, and in a manner that provided protection for him as well as for other residents. P. Br., at 3. Petitioner adds that an in depth analysis of the root causes of the resident's outbursts would not have been useful in preventing further misbehavior.

Linda Teri, a clinical psychologist and expert in behavior management of residents in nursing homes testified on behalf of CMS. She opined that prevention is always better, especially in cases of agitation. Tr. 160. According to her, preventative strategies would have allowed staff to observe the patient, to see what kinds of things might be triggering the combative episodes. Ms. Teri also took issue with the administration of medication after the resident displayed agitation. She suggested that it would be preferable for the staff to be possessed with ability to distract or redirect the resident rather than rely on medication or security. Tr. 159.

The evidence of record reveals that the root cause of R2's agitated behavior was his dementia. To determine what factors may have triggered the manifestation of such behavior is a slippery slope indeed. As stated above, Ms. Teri testified that preventative strategies would have allowed staff to observe the patient, to see what kinds of things might be triggering the combative episodes. Trying to pin down those triggering factors may be more elusive than apparently suggested by Ms. Teri. In this regard, it was noted by Ms. Deborah Barnhardt, the Nurse Practitioner, that it is sometimes very difficult to determine why a resident has become agitated. She outlined several causes that might lead a resident with dementia to act out in a disruptive fashion. Some of the factors she mentioned included the following:

� Infectious process.

� Physical ailments such as constipation or burning on urination.

� Effects of medication.

� Desire to be left alone.

� Desire to leave the facility and go home.

� Wanting their mothers.

� Unfamiliarity with the surroundings.

� Tendency to become territorial.

Tr. 239-241.

Thus, when a demented resident, such as R2, manifests a sudden change in behavior, it is not something that can be anticipated, nor is there an easy formula to establish a reason for the change. Without clear and convincing evidence that through noncompliance with participation requirements, the facility somehow provoked the change, the facility may not be held liable for the resident's deterioration in behavior.

For instance, on April 14, 2004, when R2 became combative for the first time, the facility could not have anticipated that the resident would deviate from his normal behavior. Consequently, what needs to be considered is what the facility did once the resident exhibited combative outbursts. In this regard, Ms. Linda Teri testified that rather than just calling security, the staff should distract agitated residents as a means to calm them down. She also suggested that they should look for ways to identify the source of increasing combative behavior. She noted the importance of protecting the affected resident as well as other residents from combative behavior. Tr. 159-161.

The evidence of record reflects that R2 had shown signs of confusion several months prior to April 2004. P. Ex. 26, at 11. However, at that time he did not exhibit bouts of repeated unruly conduct. Because of his confusion, he did not know how to return to his room and staff redirected him. P. Ex. 26, at 3, 4. Resident progress notes also show that prior to April 2004, R2 was being monitored. P. Ex. 26, at 7, 8.

In a statement dated May 5, 2004, by B. Whittle, a registered nurse, it is revealed that during the time when R2 began to display combative conduct, he was redirected and monitored so as to never allow any resident near him during moments of outbursts. CMS Ex. 7, at 53. It was also noted that all staff members were familiar with the resident and were aware of his whereabouts at all times. This monitoring of the resident is consistent with the opinion voiced by Ms. Teri.

Additionally, Ms. Amy Fann (a Registered Nurse, qualified as a expert witness in long-term care nursing) testified that staff was alert to situations that may trigger agitation in the resident. She referenced an occasion when R2 could not find his chewing tobacco, and the treatment administration record was annotated to make the staff aware of his need to find his chewing tobacco when he looked for it. Tr. 421. She also mentioned that on the evening of April 16, 2004, when the resident was observed with a hammer in his hand, he had taken it from a drawer at the nurses' station where he was rummaging, looking for his knife. Id. The inference that I draw from Ms. Fann's testimony is that the resident became combative because he could not find his knife, and not that he was looking for his knife because he was combative.

Of course, whether he in fact misplaced a knife may have been something that existed only in his mind, as there is no evidence that he did possess such object. Tr. 421-422. Consequently, I am persuaded to find that the use of pharmacology and a security guard to help calm the resident and protect other residents were not the only interventions employed by the facility.

Ms. Teri's suggestion that the use of security was not desirable (Tr. 159) is refuted by the testimony of Ms. Amy Fann, who testified that the use of a security guard was a proper intervention because it provided protection for other residents and reassured them that through his presence they were safe. Regarding R2, she stated that inasmuch as individuals with dementia respond to what is familiar, the uniform and badge triggered a sense of respect. She added that R2 calmed down when he saw the security guards. Tr. 426.

One of the residents who had exhibited fear of R2's unruly conduct (identified as Resident 31) was visited by the social services director on April 17, 2004 and again on April 20, 2004. He explained to her the circumstances surrounding the acute episodes of outbursts by R2 and was reassured that nursing would monitor R2 and that security would be available every night to check on him. She was also offered a change of room, but she refused. ⁽²⁾ CMS Ex. 7, at 36, 61. On the other hand, R2 was isolated in a room by himself, and as stated, was monitored by staff and security. CMS Ex. 7, at 36; Tr. 277.

On April 19, 2004, the Nurse Practitioner met with R2's sister who was also his legal guardian. P. Ex. 9. Upon the sister's request, some of the resident's medications were discontinued. Tr. 243. The sister who represented having a health care background and a good knowledge of the resident, opined that he was moving about like a zombie due to his medication regimen. Tr. 242.

Furthermore, it was her belief that the recent behavioral changes were directly attributable to the psychiatric medication. Tr. 242-243. Ms. Barnhardt felt that there may be a foundation for linking the resident's change in behavior especially in the case of Risperdal, a medication whose side effect may cause restlessness. Additionally, Ativan, which had been administered intramuscularly, had not been effective in providing lasting relief. See CMS Ex. 1 at 55. In view of the sister's promise that a family member would come to the facility when called in case there was a re-emergence of the resident's combative behavior, Ms. Barnhardt agreed to a trial of cessation of the medication. She also felt that a familiar face would have a comforting effect on R2 if a family member went to the facility if there was a change in behavior. Tr. 243-244, 260.

From April 19, 2004 until April 30, 2004, there were no reports of combativeness on the part of R2. The resident did well after discontinuation of psychotropic medication, and the family members were responsive to facility calls to go to the facility and sit with him. Tr. 244. Contrary to CMS's assertion, the absence of a detailed written record of monitoring by facility staff during the period from April 19, 2004 through April 29, 2004, is not evidence of resident exposure to accidents or abuse.

The thrust of CMS's argument is that the facility did not conduct an assessment in order to determine why the resident was getting upset and what could be done to prevent him from becoming agitated. CMS Br., at 2. This contention is highlighted by a question posed to Ms. Barnhardt by Counsel for CMS when she stated that it was her understanding that the facility had security come up to sit with the resident in addition to calling the family and the family providing those services as well.

The question is as follows:

Q. Just to make sure I understand you, when you say they had security come up to sit with the resident, is it your understanding that this would be before or after the onset of an episode of agitation?

A. I do not know.

Tr. 290.

That's the same as asking whether the firefighters were called before or after the fire started. It was incumbent upon the facility to have measures in place to protect R2 and other residents from harm in case he became agitated, but it was not expected that the facility should call the family members or security in anticipation of an episode of agitation. Thus, at least during the first three periods here under consideration, CMS has unfairly imposed remedies on Petitioner because it "failed" to prevent R2 from experiencing combative outbursts. This is not a case where the facility has simply crossed its arms without taking any action to protect its residents from accidents and abuse. In fact, the facility was aggressively dealing with a difficult situation. Moreover, on April 16, 2004, the staff was in-serviced on resident to resident abuse. Tr. 403.

I, therefore, find that the facility brought to bear adequate resources and diligence in mid April 2004 to deal with a sudden and difficult change in R2's behavior. To Petitioner's credit, it made earnest attempts to deal with the resident's unruly behavior, rather than simply discharging him from the facility at the first sign of behavioral change.

The fourth period concerns the time from April 30, 2004 until May 5, 2004. On April 30, 2004, at 10:00 p.m., R2 was observed to be upset and swinging a belt. P. Ex. 1, at 4. The resident's family was contacted and he calmed down. However, the facility did nothing to prevent R2 from continuing to have access to items with which he could cause harm to others. He had been observed threatening others with a belt on April 15 and 16, 2004, yet on April 30 he still had access to that item. CMS Ex. 1, at 56. On May 2, at 12:00 a.m., R2 again became very upset and verbalized doing harm to staff and other residents. An order was obtained for Ativan 1 mg. P. Ex. 1, at 4. When Ativan was administered in mid April it proved not to have a lasting effect. Thus, it is not surprising that when given again in early May, that medication was inadequate to calm him down. Additionally, family members refused to go to the facility to help control his behavior. Tr. 29; CMS Ex. 7, at 24A. The facility's handling of R2's behavior in mid April 2004 had a rational basis, but the methods employed and found acceptable then, were no longer adequate in early May 2004.

From May 2-5, R2 continued to have bouts of agitation and threatening behavior. He entered other residents' rooms with a belt wrapped around his hand and threatened to kill them as he swung the belt buckle at staff and female residents. CMS Ex. 1, at 57. During this time, the facility had no plan to deal with the situation and relied heavily on the security guard. The resident was sent to the emergency room after being physically subdued by three staff members and given intramuscular medication. CMS Ex. 1, at 5. In the struggle, the resident struck two CNAs. The resident was afterwards discharged and he did not return to the facility.

In view of the foregoing, I find that from April 30 until May 5, 2004, the facility failed to implement policies and procedures that prohibit neglect and abuse of residents as required by 42 C.F.R. � 483.13(c)(1)(i). Specifically, the facility failed to protect its residents from being placed in a state of fear by the threats of R2 and also placed them in danger of suffering serious injury, harm, impairment, or death.

I conclude, therefore, that Petitioner has overcome CMS's prima facie showing that the facility was not in substantial compliance from April 13, 2004 through April 29, 2004. It is also my conclusion that the facility was not in substantial compliance from April 30, 2004 until May 5, 2004, at the immediate jeopardy level.

IV. CMS's finding of immediate jeopardy was not clearly erroneous.

Immediate jeopardy exists where a provider's noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident." 42 C.F.R. � 488.301. For a finding of immediate jeopardy, it is not necessary to show that the noncompliance caused serious injury, harm, impairment, or death. It is sufficient to show that the noncompliance was likely to cause serious injury, harm, impairment, or death. Fairfax Nursing Home, Inc., DAB No. 1794, at 14 (2001).

The prima facie evidence from April 30, 2004 until May 5, 2004, strongly supports a finding of an immediate jeopardy level deficiency.

Petitioner should have foreseen that when all of the previous interventions were no longer effective, the presence of an uncontrollable and combative resident in the facility was likely to result in serious injury, harm, impairment, or death to vulnerable residents who were gripped with fear when it was evident that nothing more could be done by the facility to bring R2's outbursts under control.

Additionally, I must uphold CMS's determination as to immediate jeopardy unless it is clearly erroneous. 42 C.F.R. � 498.60(c)(2). Petitioner has not met its burden of showing that CMS's determination of immediate jeopardy is clearly erroneous.

V. The amount of the penalty imposed by CMS is reasonable.

The CMP is based on a finding of immediate jeopardy, effective April 30, 2004 until May 5, 2004, at the rate of $3,050 per day of non compliance.

I agree with CMS that Petitioner's staff exhibited neglect during the aforementioned period in failing to implement policies and procedures to protect its residents from experiencing fear of harm as well as the likelihood of suffering harm from an unruly, combative, and uncontrollable resident.

Petitioner contends that CMS failed to provide any basis for a finding of immediate jeopardy that justifies the imposition of a $3,050 penalty. I have already discussed the basis for a finding of noncompliance. Indeed, there is not only a prima facie case of noncompliance here, but the preponderance of the evidence is that Petitioner was not complying substantially with the regulatory requirements under 42 C.F.R. � 483.13(c)(1)(i).

Furthermore, Petitioner has not met its burden of showing that CMS's determination of immediate jeopardy is "clearly erroneous." Clearly erroneous is a very high standard. ⁽³⁾ Without clear and convincing evidence from Petitioner on this issue, I cannot find CMS's determination of immediate jeopardy to be clearly erroneous.

Moreover, there is no issue as to the reasonableness of the CMP imposed, inasmuch as $3,050 is the minimum under the regulations, where it is established that the participating facility has incurred a deficiency that reaches the level of immediate jeopardy. 42 C.F.R. � 488.438(a)(i).

VI. Conclusion

Based on the testimony offered at the hearing, the documentary evidence, the arguments of the parties, and the applicable law and regulations, I find that Petitioner was not in substantial compliance at the immediate jeopardy level from April 30, 2004 until May 5, 2004, and that the imposition of a $3,050 per day CMP is reasonable. Petitioner was in substantial, compliance from April 13, 2004 through April 29, 2004.

José A. Anglada

Administrative Law Judge

1. ^{CMS appears to be confused as to the events surrounding the third and fourth periods. It was during the third period that R2 was quiet at a time when his medication was discontinued. He was given medication again after April 30, when his combative outbursts re-emerged. CMS Br., at 19.}

^{2. The social services director, Mark Schindler, called Ms. Kate Clark, the DON on Saturday, April 17, 2004, to inform her of the incident involving R2. He discussed with her the advisability of moving R2 to another unit, but she decided against it because: (1) they would have the family sit with him; (2) the nursing staff would continue to monitor him; and (3) a restraint would be used if necessary. Ms. Clark also instructed Mr. Schindler to speak with the alert residents that had expressed a concern and reassure them that they were safe. CMS Ex. 7, at 32.}

^{3. A finding is clearly erroneous when "although there is evidence to support it, the reviewing court on the entire evidence is left with the definite and firm conviction that a mistake has been committed," (U.S. v. United States Gypsum Co., 333 U.S. 364, 395 (1948)) or when a finding is "unsupported by substantial evidence, contrary to the clear weight of the evidence, or induced by an erroneous view of the law." Gasifier Mfg. Co. v. General Motors Corp., 138 F. 2nd 197, 199 (8th Cir. 1943).}