SUBJECT:

Fayetteville Health & Rehabilitation Center,

Petitioner,

Centers for Medicare & Medicaid

I decide that Petitioner, Fayetteville Health & Rehabilitation Center, did not comply substantially with Medicare participation requirements during a period that began on November 16, 2000 and which ran through January 11, 2001. I decide that Petitioner did not prove to be clearly erroneous the determination by the Centers for Medicare & Medicaid Services (CMS) that the level of Petitioner's noncompliance on November 16, 2000 was such as to place residents of Petitioner's facility at immediate jeopardy. I find that a $7,500 civil money penalty is a reasonable penalty for Petitioner's noncompliance on that date. I find to be reasonable the $200 per day civil money penalties that CMS determined to impose against Petitioner for Petitioner's noncompliance during the period which ran from November 17, 2000 through January 11, 2001. Finally, I find that CMS was authorized to impose other remedies against Petitioner, including denial of payment for new Medicare admissions for the period which ran from December 21, 2000 through January 11, 2001.

I. Background

Petitioner is a skilled nursing facility that is located in Fayetteville, Arkansas. It participates in the Medicare program and its participation in that program is governed by federal statutes and regulations which include regulations at 42 C.F.R. Parts 483 and 488.

On November 14 - 16, 2000, Petitioner was surveyed for compliance with Medicare participation requirements by a surveyor employed by the Arkansas Department of Human Services (Arkansas State survey agency). The surveyor, and subsequently, the Arkansas State survey agency, found that Petitioner was not complying substantially with seven distinct Medicare participation requirements. The surveyor and the Arkansas State survey agency determined that the level of Petitioner's noncompliance with these requirements was so egregious as to constitute immediate jeopardy for residents of Petitioner's facility.

During the afternoon of November 16, 2000, Petitioner's staff submitted a plan of correction to the surveyor. That plan was accepted by the Arkansas State survey agency and it determined that Petitioner had abated the immediate jeopardy level noncompliance as of that day. The Arkansas State survey agency concluded, however, that Petitioner remained substantially noncompliant with Medicare participation requirements until January 11, 2001 when it attained full compliance with participation requirements.

CMS concurred with the Arkansas State survey agency's findings. It determined to impose remedies against Petitioner which consisted of the following:

� A civil money penalty of $7,500 to address the alleged immediate jeopardy level deficiencies of November 16, 2000;

� Civil money penalties of $200 per day for each day of a period beginning on November 17, 2000 and running through January 11, 2001 to address the non-immediate jeopardy level deficiencies that Petitioner allegedly manifested during this period; and

� Denial of payments for new Medicare admissions for each day of a period beginning on December 21, 2000 and running through January 11, 2001.

Petitioner requested a hearing to contest the imposition of these remedies. I scheduled an in-person hearing in Little Rock, Arkansas, on December 10, 2002. I appeared on that date and was ready to proceed as were the parties. Unfortunately, due to an administrative error by United States Department of Health and Human Services personnel, no court reporter appeared and I had no choice but to cancel the hearing. The parties agreed that the hearing could be rescheduled as a telephone hearing and I scheduled that to take place on February 27, 2002. Prior to the rescheduled hearing, the parties agreed that they would make their evidentiary presentations in writing. The parties offered into evidence exhibits which include the written direct testimony of witnesses. The parties also submitted pre- and post-hearing briefs and reply briefs.

I received into evidence exhibits from CMS consisting of CMS Exs. 1 - 3, 5 - 11, and 15 - 21. CMS Ex. 20 is the affidavit of Regina Henry. CMS Ex. 21 is the affidavit of Daniel McElroy. I received into evidence exhibits from Petitioner consisting of P. Ex. 2, and P. Exs. 10 - 39. P. Ex. 33 is the affidavit of Dr. Joe Rouse. P. Ex. 34 is the affidavit of Jamie Lovett. P. Ex. 35 is the affidavit of Terry Hurley Cook. P. Ex. 36 is the affidavit of Greg Wooten. P. Ex. 37 is the affidavit of Dawna Wilder. P. Ex. 38 is the affidavit of Kirsty Unkel. P. Ex. 39 is the affidavit of Elaine Townsley.

II. Issues, findings of fact and conclusions of law

A. Issues

The issues in this case are whether:

1. As of November 16, 2000 Petitioner failed to comply substantially with one or more Medicare participation requirements;

2. CMS's determination that Petitioner's noncompliance with Medicare participation requirements as of November 16, 2000 placed residents at immediate jeopardy is clearly erroneous;

3. From November 17, 2000 through January 11, 2001 Petitioner continued to fail to comply substantially with Medicare participation requirements, albeit at a level of noncompliance that is less than the immediate jeopardy level;

4. The remedies that CMS determined to impose against Petitioner are authorized and, in the case of civil money penalties, reasonable.

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 failed to comply substantially with Medicare participation requirements as of November 16, 2000.

The Arkansas State survey agency and CMS found that, as of November 16, 2000, Petitioner was not complying substantially with seven distinct participation requirements. CMS Ex. 1, at 1 - 26. Below, at subparts 1.a. - 1.g. of this Finding, I sustain CMS's determinations as to five of these seven allegations of noncompliance.

All of the allegations of noncompliance center around the care that Petitioner gave to two of its residents. These residents are identified in the survey report as Resident # 1 and Resident # 5.

Many of the facts which are cited as a basis for the noncompliance allegations are not disputed. These undisputed facts are as follows:

� Resident # 1 was diagnosed to be suffering from ailments which included a head injury resulting from a motor vehicle accident, a seizure disorder, and arteriosclerotic heart disease. CMS Ex. 1, at 4. The resident was totally dependent on Petitioner's staff for most activities of daily living. The resident had no history of having suffered from diabetes, hypoglycemia, or hyperglycemia. Id.

At 5:00 p.m. on the evening of October 30, 2000, Petitioner's nursing staff observed that the resident was exhibiting signs that were unusual for her. These signs were first noticed as the resident was being taken out of her room by her husband. CMS Ex. 1, at 4; CMS Ex. 11, at 14. The resident was noted to be extremely red-faced with her skin wet and cool to the touch. The resident did not respond to verbal stimuli. Id. A finger stick blood sugar test showed the resident's blood sugar level to be at 29, as compared to normal readings of between 70 and 110. CMS Ex. 1, at 4. Petitioner's staff administered Glucagon to the resident in an attempt to increase her blood sugar levels. Id.

At 5:30 p.m. the staff performed a repeat finger stick blood test on Resident # 1. Her blood sugar was documented at this time to be 83. The resident remained extremely lethargic and responded sluggishly to verbal stimuli. CMS Ex. 1, at 4. A repeat finger stick test at 7:20 p.m. showed that the resident's blood sugar level had dropped to 61. CMS Ex. 11, at 14. It was difficult to obtain a verbal response from the resident. The resident was given orange juice. At about 7:30 p.m. Petitioner's staff notified Resident # 1's physician about the resident's condition.

CMS Ex. 1, at 4; CMS Ex. 11, at 14. The resident's clinical record does not document earlier attempts to notify the physician. See CMS Ex. 11, at 14 - 15. At 9:45 p.m., the doctor ordered the resident to be transported to a local emergency room. CMS Ex. 11, at 15.

� Resident # 5 had several cardiac or cardiac-related conditions. His diagnoses included atrioventricular block, hypertension, and congestive heart failure. CMS Ex. 1, at 2. The resident wore a pacemaker. The resident had a physician's order for oxygen as needed for shortness of breath. Id. Petitioner's staff prepared a plan of care for the resident dated October 20, 2000. It documented a problem under the heading of "alteration in cardiovascular functions" and it indicated that appropriate interventions would be to report any abnormal vital signs to a physician for evaluation and to monitor the resident closely for any signs or symptoms of cardiac complications. Id.; CMS Ex. 15, at 7.

The resident was observed by Petitioner's staff on November 4, 2000, at 2:00 a.m., to be lying in bed with his head elevated. His color was pale and he appeared to be short of breath. CMS Ex. 1, at 3; CMS Ex. 15, at 5. His blood oxygen saturation level was reported at that time to be 82 percent. Resident # 5's customary average blood oxygen saturation was in the low nineties. P. Ex. 38, at 5. His pulse was recorded to be 42 beats per minute. CMS Ex. 1, at 3; CMS Ex. 15, at 5. According to his plan of care, the acceptable range for his pulse was 60 to 90 beats per minute. P. Ex. 11, at 6. The resident refused to have his blood pressure taken. He was observed to have bounding pulses. The staff administered oxygen to the resident and noted that they would monitor his condition. CMS Ex. 1, at 3; CMS Ex. 15, at 5.

At 2:30 a.m., the resident's blood oxygen saturation level was down to 75 percent. CMS Ex. 1, at 3; CMS Ex. 15, at 5. Resident # 5's pulse had increased to 130, he displayed mild cyanosis in his lips, and he complained of pressure in his chest. He again refused to allow his blood pressure to be taken. Id. Petitioner's staff administered sublingual nitroglycerin to the resident and called the resident's physician. Id. At 2:45 a.m., the physician returned the call. He ordered that the resident should be transported to the emergency room if his condition did not improve. Id. Resident # 5 was transported to the hospital at 3:30 a.m. P. Ex. 15, at 5.

a. Petitioner failed to comply substantially with the requirements of 42 C.F.R. � 483.10(b)(11).

CMS alleges that Petitioner failed to comply substantially with the requirements of 42 C.F.R. � 483.10(b)(11). CMS Ex. 1, at 1 - 5 (Tag 157). This regulation provides in relevant part that a facility must,

immediately inform the resident; consult with the resident's physician; and if known, notify the resident's legal representative or an interested family member when there is -

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(B) A significant change in the resident's physical, mental, or psychosocial status (i.e., a deterioration in health, mental, or psychosocial status in either life-threatening conditions or clinical complications);

(C) A need to alter treatment significantly (i.e., a need to discontinue an existing form of treatment due to adverse consequences, or to commence a new form of treatment) . . . .

42 C.F.R. � 483.10(b)(11)(i)(B) and (C).

CMS alleges that Petitioner failed to comply substantially with the quoted language in that it failed to consult with the physicians of Residents #s 1 and 5 about significant changes in the residents' conditions and about the need to commence new forms of treatments for the residents. Specifically, CMS asserts that Petitioner's duty to consult required Petitioner's staff to have notified the physician of Resident # 1 at 5:00 p.m. on October 30, 2000 when the resident first began showing signs of an insulin overdose rather than waiting until 7:30 that evening to make the notification. It asserts that the staff should have notified Resident # 5's physician at 2:00 a.m. on November 4, 2000 of the resident's respiratory distress and reduced blood oxygen saturation level rather than waiting until 2:30 a.m. to notify the physician. CMS also asserts that Petitioner's staff erred by altering the residents' treatment by administering medications to Residents #s 1 and 5 that had not been previously prescribed - consisting of Glucagon in the case of Resident # 1 and nitroglycerin in the case of Resident # 5 - without first consulting with the residents' treating physicians.

The undisputed facts concerning the care that Petitioner gave to the two residents is prima facie evidence of Petitioner's noncompliance with the requirements of the regulation. The regulation imposes two duties on Petitioner which these facts show Petitioner to have not performed. First, Petitioner was obligated to notify the treating physicians of Residents #s 1 and 5 immediately of significant changes in the residents' conditions. 42 C.F.R. � 483.10(b)(11)(i)(B). Here, both residents were showing signs of significant deterioration and, based on the above-stated facts, Petitioner's staff failed to make the required immediate notifications. In the case of Resident # 1, the resident, who had no known history of diabetes, hypo- or hyperglycemia, went into a state that Petitioner's staff recognized to be a severe blood sugar-related event. Her blood sugar level, at 5:00 on the evening of October 30, 2000, was far below what is recognized to be normal. She had become non-responsive. The resident's condition was so severe that the staff administered Glucagon, and then, orange juice to her, in an attempt to restore normal function. Yet, for a period of two and one-half hours, while this crisis was ongoing, staff failed to notify the resident's physician.

Resident # 5's care plan required that the resident's physician be notified of any abnormal vital signs, especially signs of alteration in cardiovascular function. At 2:00 a.m. on the morning of November 4, 2000, the resident displayed vital signs that manifestly were abnormal, including a decreased and deteriorating blood oxygen saturation level of 82%. Resident # 5's customary average blood oxygen saturation was in the low nineties. P. Ex. 38, at 5. The Lippincot Manual for Standards of Nursing Practice provides that oxygen saturations of less than 92% should be reported to a patient's doctor for possible treatment. CMS Ex. 1, at 16. The nurses notes also reflect that at 2:00 a.m. Resident # 5's pulse rate was 42 beats per minute. The appropriate range for his pulse was 60 to 90 beats per minute. P. Ex. 11, at 6. The notes indicate that Resident # 5 was lethargic and that he had bounding pulses. These were signs of alteration in cardiovascular function; however, Petitioner's staff waited for one-half hours before notifying the resident's treating physician.

Second, the regulation requires immediate consultation with a resident's physician when there is a need to alter the treatment given to a resident. 42 C.F.R. � 483.10(b)(11)(i)(C). The undisputed facts are prima facie proof that Petitioner failed to perform this duty in the case of Resident # 1. Petitioner's staff determined that it was necessary to administer Glucagon to Resident # 1 at about 5:00 on the evening of October 30, 2000, based on the resident's dramatically lowered blood sugar and signs of distress. This constituted a
significant alteration in the care Petitioner's staff gave to the resident. The resident had no history of diabetes or of hypo- or hyperglycemia. Yet, the staff waited for two and one-half hours before notifying the resident's physician of the change in the resident's treatment. ⁽¹⁾

The prima facie evidence also shows that Petitioner's noncompliance with the requirements of the regulation was substantial because it posed a greater risk to resident health or safety than the potential for causing minimal harm. 42 C.F.R. � 488.301. Both Resident #s 1 and 5 showed severe deteriorations in their conditions. Each of these residents was in a potentially life-threatening state during the period of time when Petitioner's staff should have notified the resident's physician about the resident's altered condition. Failure to notify the physician could have deprived each resident of potentially life saving care.

The potential for harm to Resident # 1 lay in the fact that the resident was suffering from a potentially life-threatening condition. Petitioner's staff understood this to be the case; however, at the time that the staff administered medication to the resident and during the subsequent two and a half hours, it had no way of knowing whether the physician would have concurred with that treatment or whether the physician would have ordered different care for the resident. ⁽²⁾ The potential for harm in delaying consultation is made clear in the case of Resident # 5 by the fact that the resident's physician, upon finally being notified, ordered that the resident be sent to the hospital.

Petitioner's arguments about its discharge of its obligations under 42 C.F.R. � 483.10(b)(11)(i) do not overcome CMS's prima facie case. First, Petitioner argues that it had no duty to notify the treating physicians of Residents #s 1 and 5 immediately of significant changes in the residents' conditions or of alterations in the residents' care. Petitioner asserts that:

the Federal regulation requires immediate notification of a resident, but requires the facility to consult with the physician. The regulation does not require the consultation of the physician to take place prior to taking any action with the patient, but rather those matters are left to standards of practice, emergency patient circumstances and conditions that present requiring facility staff intervention, and physician orders.

P. Pre-hearing Br. at 2 - 3. As Petitioner reads the regulation it requires immediate notification of a resident of a significant change in the resident's condition or of alteration in treatment, but not necessarily immediate consultation with the resident's physician. The timing of physician notification, according to Petitioner, depends on "standards of practice" and other factors.

Petitioner apparently hinges this argument on language in the regulation which states that a facility must: "immediately inform the resident; consult with the resident's physician . . . ." in the case of a significant change in a resident's condition and/or alteration of care being given to a resident. Petitioner seems to place emphasis on the presence of a semi-colon between the words "resident" and "consult" and the absence of "and" to link the two phrases.

Petitioner's averred interpretation makes no sense. The facility and its staff function under the supervision and control of the physician. Ultimately, it is the physician's responsibility to decide what care is given to his or her patient. The facility cannot substitute its judgment for that of the physician. Given that, it would be illogical for the facility to have a less stringent notification duty with respect to the physician who decides on the resident's care than it has with respect to the resident.

Additionally, the comments in the preamble to the published regulation show that the intent of the regulation is that the physician be notified immediately. Those comments state:

Comment: Over 50 commenters responded to the requirement concerning notification of changes in the resident's health condition. ⁽³⁾ Several commenters suggested this requirement be rewritten. As it is currently worded, they pointed out, it means that in a medical emergency or in the case of a competent individual the facility does not have to tell the resident what is happening to him or her. Nor, in these two situations, does the facility have to contact the resident's physician and the legal representative or family to notify them of the changes.

Response: The interpretation of the commenters is not what we intended. We are clarifying the wording of this provision to indicate that in all cases, whether or not there is a medical emergency, the facility must notify the resident; his or her physician; and any legally-appointed representative or an interested family member, if known.

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Comment: Twelve commenters objected to granting the facility up to 24 hours in which to notify the resident's physician and the legal representative or family. As some noted, a resident could be dead or beyond recovery in that time and the family would be denied the opportunity of being with their loved one during the time of crisis.

Response: We agree and have amended the regulation to require that the physician and legal representative or family be notified immediately.

56 Fed. Reg. 48826, 48,832 - 48,833 (Sept. 26, 1991)(emphasis added).

Furthermore, Petitioner has not offered any credible evidence to prove that applicable standards of practice would require anything less than immediate physician notification in the circumstances that are at issue in this case. Indeed, the testimony of one of Petitioner's own witnesses, Joe Rouse, M.D., Petitioner's medical director, is evidence that Petitioner's staff should have been more prompt in notifying Resident # 1's treating physician of changes in that resident's condition. His testimony contains the following colloquy:

Q: An event is described in Petitioner's Exhibit 20 where a resident was administered Glucagon. Do you agree with the administration of Glucagon in the situation described in Petitioner's Exhibit 20?

A. By administering Glucagon in this situation, the resident's life was probably saved. However, the nurse probably should be reprimanded for not notifying the doctor in a more timely fashion.

P. Ex. 33, at 2 (emphasis added).

Second, Petitioner argues that the blood-sugar related deterioration in Resident # 1's condition on the evening of October 30, 2001 did not constitute a significant change in the resident's condition. P. Post-hearing Reply Br. at 5 - 6. In support of this argument Petitioner cites to the definition of a "significant change" in 42 C.F.R. � 483.20(b)(2)(ii). The regulation defines the term in the context of a facility's duty to conduct a comprehensive assessment of a resident's condition:

For purposes of this section, a "significant change" means a major decline or improvement in the resident's status that will not normally resolve itself without further intervention by staff or by implementing standard disease-related clinical interventions, that has an impact on more than one area of the resident's health status, and requires inter-disciplinary review or revision of the care plan, or both.

Id. Using this definition Petitioner contends that Resident # 1 did not experience a significant change at the time that a nurse administered Glucagon to the resident because administration of this medication "is a recognized standard disease related clinical intervention for that presenting medical emergency." P. Post-hearing Reply Br. at 5 - 6.

I am not persuaded by this argument. The definition of "significant change" in 42 C.F.R. � 483.20(b)(2)(ii) is explicitly limited to the context of that regulation and is not applicable elsewhere in the regulations. There is a different regulatory definition of "significant change" in 42 C.F.R. � 483.10(b)(11)(i)(B):

[A] deterioration in health, mental, or psychosocial status in either life-threatening conditions or clinical complications.

Resident # 1's condition plainly met this condition on the evening of October 30, 2001. She experienced a life-threatening deterioration in her health.

Petitioner also argues that the failure to notify the physicians in the two instances that are at issue did not pose a potential for more than minimal harm to the residents. I find this argument to be without merit. The overwhelming evidence is that both residents experienced life-threatening emergencies which mandated immediate physician intervention. It is true that neither resident appears to have suffered actual harm from the events that transpired. But, the potential for serious harm or even death was high in both cases. For example, as is apparent from Dr. Rouse's testimony, Resident # 1 was involved in a life-or-death event. P. Ex. 33, at 2. The fact that the nurse who cared for the resident opted to administer care to that resident that, when viewed with hindsight, was appropriate and which would have been prescribed by a physician had the physician known about the problems that the resident was experiencing is fortuitous. But, that does not detract from the conclusion that immediate physician notification was necessary precisely because the resident was experiencing problems that fell within the unique purview of a physician to diagnose and to treat.

b. Petitioner failed to comply substantially with the requirements of 42 C.F.R. � 483.13(c).

CMS alleges that Petitioner failed to comply substantially with the requirements of 42 C.F.R. � 483.13(c). CMS Ex. 1, at 5 - 9 (Tag 225). This regulation imposes duties on a facility to, among other things: ensure that all allegations of resident abuse are reported; investigate episodes of potential abuse thoroughly; and, prevent further potential abuse from occurring while the investigation is in process. CMS's allegations of noncompliance relate to the care and attention that Petitioner's staff gave to Resident # 1 after a laboratory report received on November 7 confirmed that Resident # 1 had been given an injection of insulin on October 30, 2000.

CMS's allegations are premised on the undisputed facts that I have described above at the preamble to this Finding and on some additional facts which I describe here. The resident's husband, who was present at Petitioner's facility at 5:00 p.m. when Resident # 1 first began to display signs of blood sugar-related problems, appeared to be unconcerned about those problems and left, telling the facility staff to call him if the staff decided to send the resident to the hospital. CMS Ex. 1, at 7. Upon being notified of the resident's condition, Resident # 1's treating physician inquired of Petitioner's staff whether anyone, including the resident's husband, had administered insulin to the resident. Id. Between 8:30 and 9:00, Resident # 1's husband was contacted at home about the resident's condition. P. Ex. 37, at 5. While the nurse's notes reflect that he requested that his wife be sent to the hospital (CMS Ex. 11, at 15), the Petitioner's investigative report (P. Ex. 29, at 8) and the police report indicate that the nurses "had to convince [the husband] that [Resident # 1] needed to be transported and he finally told them that if the doctor said she needed to go, it was okay with him." P. Ex. 30, at 5.

At the hospital, Resident # 1 was found to have a bruise on her abdomen which was consistent with her having been given an injection. P. Ex. 27, at 1; P. Ex. 30, at 3. Blood tests were performed on Resident # 1 and Petitioner obtained the results on November 7, 2000. The tests showed that, on October 30, 2000, the resident had been administered synthetic insulin. CMS Ex. 1, at 7 - 8. Members of Petitioner's staff denied administering insulin to the resident. Id. Petitioner immediately conducted an investigation of this incident and, in its report to the Arkansas state survey agency on November 7, 2003, stated that, as a precaution, the resident would be checked at 15 - 30 minute intervals while the resident's husband was visiting the facility. ⁽⁴⁾ CMS Ex. 11, at 8. Upon Petitioner's report of the incident to the police on November 7, the police began on an investigation as to whether Resident # 1's husband administered insulin to the resident on the evening of October 30. P. Ex. 30. This investigation remained open several months but the police were unable to determine how Resident # 1 received the insulin. P. Ex. 34, at 2 - 3.

On November 14, 2000, the surveyor interviewed the licensed practical nurse who was responsible for Resident # 1's care. The nurse denied that she had been given any specific instructions concerning monitoring the resident's visitors or the administration of insulin to the resident. CMS Ex. 1, at 8. Also, on November 14, 2000, the surveyor asked the registered nurse who routinely worked in the hall where Resident # 1 resided whether he had been given any instructions to monitor or supervise any visitors to Resident # 1. The nurse denied having been given any instructions. Id. The surveyor also interviewed Petitioner's director of nursing and administrator on November 14, 2000 and inquired as to what steps had been taken to protect Resident # 1 from additional harm. These individuals stated that no special steps had been taken to protect the resident. Id. On November 15, 2000, the surveyor again asked the administrator if any steps had been implemented to protect Resident # 1 and the administrator stated that he was unaware that any had been implemented. CMS Ex. 1, at 9.

These facts establish a prima facie case of noncompliance by Petitioner with the requirements of 42 C.F.R. 42 C.F.R. � 483.13(c). The regulation imposes a duty on a facility to protect a resident from possible additional abuse while a previous episode of potential abuse is being investigated. Here, the facts show that Resident # 1 potentially was "abused." The resident was not diabetic and insulin had not been prescribed for her. Some unknown person administered insulin to the resident under circumstances that suggested the intent to harm her or worse. ⁽⁵⁾ The resident was potentially at risk for additional abuse while Petitioner and the police investigated the source of the possible attack. During the period that the episode was being investigated, it was absolutely critical that Petitioner ensure that no additional attacks were perpetrated. It is reasonable to infer from the facts adduced by CMS that Petitioner, despite its promise to provide protection, did not provide any to the resident during the post-episode period.

CMS established a strong prima facie case that Petitioner's failure to provide the required protection put Resident # 1 at a high potential risk for injury or death. The potential for harm arising from this omission is obvious. The unauthorized administration of insulin to Resident # 1 potentially could have caused the resident to die. P. Ex. 33, at 2. The resident was potentially at risk for further assault so long as the source of the insulin was unknown. Moreover, the resident was helpless to protect herself given her underlying condition.

I do not find that Petitioner offered either arguments or evidence that overcome CMS's prima facie case. Petitioner offered nothing that would refute admissions by Petitioner's staff that they had not been given instructions to provide special protection or monitoring of Resident # 1 and that they had not provided special protection to the resident between November 7, 2000 and the date of the survey. See P. Exs. 34 - 39. Petitioner asserts that the affidavits of Kristy Unkel and Dawna Wilder specifically refute the surveyor's attributions of statements made by Petitioner's nursing staff. P. Pre-hearing Br. at 5; P. Exs. 37; 38. Petitioner has not pointed to any specific statements in these affidavits which allegedly refute the surveyor's attributions. Neither of the affidavits directly addresses any of the statements that were attributed by the surveyor to members of Petitioner's staff. Dawna Wilder does aver that the facility's investigative report (P. Ex. 29) established supervision guidelines for visits by Resident # 1's husband. P. Ex. 37, at 7. However, she does not aver that these guidelines were actually communicated to staff or implemented at any time after November 7.

Petitioner argues that the episode of October 30, 2000 was "fully investigated and reported by the Facility . . . ." P. Pre-hearing Br. at 5. That may be so. But, the focus of CMS's non-compliance allegations is not whether Petitioner investigated the episode but whether it protected the resident in light of the highly suspicious nature of that episode. Petitioner's assertion that it investigated the episode simply doesn't answer the question raised by CMS's findings.

Petitioner also argues that the true issue concerning the care provided by Petitioner to Resident # 1 is "the proper medical response by the Facility nursing staff in a medical emergency and the compliance with nursing standard of practice and ethics." P. Pre-hearing Br. at 5. I agree that the quality of medical care that Petitioner provided to the resident is an issue in this case. But, that issue is addressed under other allegations made by CMS concerning quality of care. See Finding 1.a. Petitioner's argument that it gave appropriate medical care to Resident # 1 on the evening of October 30, 2000 simply begs the question of whether Petitioner protected Resident # 1 after November 7 when the lab report confirmed Resident 1 had been given an injection of insulin.

c. CMS did not establish a prima facie case that Petitioner failed to comply substantially with the requirements of 42 C.F.R. � 483.20(b).

CMS alleges that Petitioner failed to comply substantially with the requirements of 42 C.F.R. � 483.20(b). CMS Ex. 1, at 10 - 13 (Tag 272). At 42 C.F.R. � 483.20(b)(1), the regulation requires that a facility must make a comprehensive assessment of a resident's needs, using a form (RAI) specified by the State. CMS premises its allegations on the undisputed facts that I recite in the preamble to this Finding. It alleges that Petitioner contravened subpart (b)(1) of the regulation because it did not make a comprehensive assessment of whether Resident # 5 would benefit from the administration of nitroglycerin prior to its staff administering nitroglycerin to the resident on November 4, 2000.

I find that CMS did not establish a prima facie case that Petitioner failed to comply with the requirements of the regulation. The regulation is not intended to establish documentation and assessment requirements that a facility must comply with prior to administering emergency care to a resident. The regulation is intended to assure that residents of a facility are assessed comprehensively and periodically as part of an orderly care planning process. The regulation establishes specific time frames for preparing written assessments. For example, 42 C.F.R. � 483.20(b)(2)(ii) requires that a facility prepare a comprehensive assessment of each resident within 14 calendar days after the facility determines, or should have determined, that there has been a significant change in the resident's physical or mental condition.

What the regulation does not require is on-the-spot revisions of comprehensive assessments to address significant changes of a sudden or emergency nature as they occur. Yet, it is sudden or emergency changes in a resident's condition that are at issue here. On November 4, 2000, Resident # 5 developed a sudden and potentially serious change in his condition. The change certainly was significant. Indeed, it was potentially life-threatening. But, although that change may have triggered the 14-day revision requirement of 42 C.F.R. � 483.20(b)(2)(ii), there is nothing in the regulation that suggests that Petitioner's staff should have revised its written comprehensive assessment of the resident on the evening of November 4 before administering emergency treatment to the resident.

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

CMS alleges that Petitioner failed to comply substantially with the requirements of 42 C.F.R. � 483.20(k)(3)(i). CMS Ex. 1, at 13 - 14 (Tag 281). This regulation states that care given by a facility to a resident must comport with professional standards of quality. Relying on the undisputed facts that I discuss in the preamble to this Finding, CMS alleges that Petitioner contravened the regulation by:

� failing to notify treating physicians immediately of significant changes in the medical conditions of Resident #s 1 and 5;

� administering medications to these residents - Glucagon in the case of Resident # 1, and nitroglycerin in the case of Resident # 5 - which had not been prescribed by the residents' physicians prior to administration; and

� providing emergency care to Resident # 5 without first performing a comprehensive assessment of that resident.

See CMS Pre-hearing Br. at 16.

The allegations that CMS makes concerning the allegedly deficient care that Petitioner gave to Residents #s 1 and 5 depend on establishing the standards of quality that Petitioner allegedly contravened. CMS has the burden of proving, prima facie, precisely what those standards are.

I am not satisfied that CMS proved that professional standards of quality prohibited the administration of Glucagon or nitroglycerin without the prior authorization of a physician where, in the nurse's professional judgment, the patient's safety would be compromised by the delay entailed in obtaining the authorization. I am not making an affirmative finding that accepted standards of nursing would have permitted Petitioner's staff to administer these medications without physician approval. But, CMS has a burden, as part of making its prima facie case, to show what it is that Petitioner did that contravened accepted standards. In order to meet that burden here, CMS is obligated to come up with some evidence or authority that demonstrates that a facility's staff must have a physician's authorization before it administers either of the two medications at issue. That evidence might have consisted of expert testimony, language in the regulations or in State law, or an excerpt from a learned treatise. CMS has offered nothing of that nature. Rather, it has operated on the assumption that administration of these medications without prior approval by a physician always violates accepted standards. I find that to be inadequate.

However, I find that CMS established a prima facie case that Petitioner failed to comply with accepted standards of quality when its staff did not perform a necessary assessment of Resident # 5 prior to administering nitroglycerin to the resident. Although Petitioner was not obligated to revise its written comprehensive assessment of the resident prior to rendering emergency care to that resident (see Finding 1.c.), it was obligated to assess the resident to determine whether administration of nitroglycerin was appropriate. In particular, Petitioner needed to know what the resident's blood pressure was because one of the adverse side effects of nitroglycerin is excessive lowering of blood pressure. CMS Ex. 1, at 18. The prima facie evidence offered by CMS establishes that Petitioner failed to monitor Resident # 5's blood pressure. Indeed, the undisputed facts are that the resident refused to allow Petitioner's staff to take his blood pressure. Given that, Petitioner's staff should have refrained from administering the medication to the resident until it assessed the resident's suitability for receiving the medication.

I also find that CMS proved a prima facie case that Petitioner failed to comply with accepted standards of quality by not notifying immediately the treating physicians of Residents #s 1 and 5 of significant changes in these residents' conditions. The requirement of immediate notification in 42 C.F.R. � 483.10(b)(11) is a standard of quality which I find that Petitioner contravened at Finding 1.a. of this decision. That deficiency is also a deficiency under 42 C.F.R. � 483.20(k)(3)(i).

I do not find that Petitioner rebutted CMS's prima facie case. Petitioner asserts that its staff's actions comport with accepted standards of practice. However, Petitioner has not offered proof to show that administering nitroglycerin to Resident # 5 without first assessing that resident for the possible effects of the medication complies with accepted standards. Nor has Petitioner shown that failing to notify the treating physicians of Residents #s 1 and 5 immediately of significant changes in these residents' conditions complies with accepted standards of practice. See Finding 1.a.

e. Petitioner failed to comply substantially with the general requirement of 42 C.F.R. � 483.25.

CMS alleges that Petitioner failed to comply substantially with the general requirement of 42 C.F.R. � 483.25. CMS Ex. 1, at 14 - 20 (Tag 309). The introductory portion of this regulation requires that each resident of a facility must receive, and the facility must provide, the necessary care and services to attain or maintain the resident's highest practicable physical, mental, and psychosocial well-being, in accordance with his or her comprehensive plan of care.

In many respects this regulation duplicates the requirements of 42 C.F.R. � 483.20(k)(3)(i), which I discuss at Finding 1.d. CMS asserts that Petitioner failed to comply with the regulation, citing the same evidence and making essentially the same arguments that it made with respect to Petitioner's asserted noncompliance with 42 C.F.R. � 483.20(k)(3)(i). Petitioner asserts the same arguments in opposition to CMS's allegations as it asserts concerning the allegations made under 42 C.F.R. � 483.20(k)(3)(i). I find that Petitioner failed to comply substantially with this regulation for the same reasons that I find that Petitioner failed to comply substantially with the requirements of 42 C.F.R. � 483.20(k)(3)(i).

f. Petitioner failed to comply substantially with the general requirement of 42 C.F.R. � 483.75.

CMS alleges that Petitioner failed to comply substantially with the general requirement of 42 C.F.R. � 483.75. CMS Ex. 1, at 20 - 23 (Tag 490). The introductory portion of this regulation provides that a facility must be administered in a manner that enables it to use its resources effectively and efficiently to attain or maintain the highest practicable physical, mental, and psychosocial well-being of each of its residents. CMS alleges that Petitioner's failure to comply substantially with other regulations is prima facie evidence that Petitioner was not administered effectively. See discussion at Findings 1.a. - 1.e.

I agree that, in this case, the facts establish a prima facie case of ineffective administration by Petitioner. That is particularly evident in the failure of the facility's staff to provide protection to Resident # 1 after the episode of October 30, 2000. The prima facie evidence is that Petitioner's management - which bore the ultimate responsibility for protecting Resident # 1 - failed to implement a plan which was designed to protect her. CMS Ex. 1, at 8.

The prima facie evidence of Petitioner's management failures is also prima facie evidence of a potential for serious harm to its residents. Resident # 1 was essentially helpless and was totally dependent on Petitioner to protect her from possible additional assaults. Absent such protection the resident's life potentially was at risk. But, Petitioner's management failed to assure the implementation of a plan to protect the resident.

Petitioner did not rebut the prima facie evidence of its noncompliance. Petitioner does not dispute that the allegations of noncompliance with 42 C.F.R. � 483.75 derive from allegations of noncompliance with other regulations. Petitioner essentially relies on the arguments it makes to challenge the other findings of noncompliance that are at issue in this case. These arguments fail here for the same reasons that I find them not to be persuasive elsewhere in this decision.

g. CMS did not establish a prima facie case that Petitioner failed to comply substantially with the requirements of 42 C.F.R. � 483.75(o)(2).

CMS alleges that Petitioner failed to comply substantially with the requirements of 42 C.F.R. � 483.75(o)(2). CMS Ex. 1, at 24 - 26 (Tag 521). The regulation requires a facility to maintain a quality assessment and assurance committee. It also mandates that the committee meets at least quarterly to identify issues with respect to which quality assessment and assurance activities are necessary. It requires that the committee develop and implement appropriate plans of action to correct identified quality deficiencies. ⁽⁶⁾

CMS alleges that Petitioner did not comply with these requirements because Petitioner did not maintain an "effective Quality Assurance Committee." CMS Ex. 1, at 24. It asserts that the other deficiencies that are, at issue in this case are prima facie case of the committee's lack of effectiveness.

I find that these allegations fail to establish a prima facie case that Petitioner did not comply substantially with the requirements of 42 C.F.R. � 483.75(o)(2). CMS has offered no evidence to show that Petitioner failed to comply with the specific requirements of the regulation. There is no evidence in the record of this case from which I might infer that Petitioner failed to establish a quality assurance committee, that the committee did not meet, at least quarterly, or that it failed to identify issues with respect to which quality assessment and assurance activities were necessary. Nor has CMS offered any evidence to show that Petitioner's quality assurance committee failed to address the issues that were surfaced by the care that Petitioner's staff gave to Residents #s 1 and 5. Rather, CMS has simply assumed that, because the care that was given to these residents was deficient, then Petitioner's quality assurance committee must have failed to discharge its obligations. I find that assumption to be inadequately supported by the record of this case.

Moreover, it is at least arguable that 42 C.F.R. � 483.75(o)(2) does not address the effectiveness of a facility's quality assurance committee. The regulation may be read as setting forth requirements addressing the formation and structure of such a committee, along with setting forth the ministerial duties of the committee. Whether the committee does a good or a bad job in assuring quality arguably is not addressed by the regulation, although it may be addressed elsewhere in the Part 483 regulations. CMS has failed to address this issue in its arguments. Rather, it has assumed that the regulation governs the effectiveness of a quality assurance committee without explaining how that is the case.

2. Petitioner did not prove to be clearly erroneous CMS's determination that Petitioner's noncompliance with Medicare participation requirements as of November 16, 2000 placed residents at immediate jeopardy.

CMS determined with respect to each of the five allegations of noncompliance that I have sustained in this decision that the level of Petitioner's noncompliance was so egregious as to place residents of Petitioner's facility at immediate jeopardy. I sustain these determinations.

"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.

42 C.F.R. � 488.301. CMS has a burden of showing, prima facie, that its determination that a deficiency met this definition is correct. If it does so, then a facility challenging that determination must prove it to be clearly erroneous. 42 C.F.R. � 498.60(c)(2).

CMS satisfied its burden in this case. There is prima facie evidence showing that both Residents #s 1 and 5 were at risk for serious or fatal consequences during the periods of time when Petitioner's staff failed to notify these residents' physicians of significant deteriorations in the residents' conditions. P. Ex. 33, at 2. And, Resident # 1 was at risk for a second assault during the period when Petitioner was obligated, but failed, to provide protection for the resident.

I do not find that Petitioner offered proof establishing that CMS's determinations of immediate jeopardy level deficiencies were clearly erroneous. Indeed, although Petitioner has challenged the presence of deficiencies, it has not offered any evidence to disprove CMS's determinations of immediate jeopardy.

Petitioner asserts that there is no evidence in this case of an instance in which a resident "was harmed by the Facility or placed in a position due to some inappropriate action of the Facility that was likely to cause harm." P. Pre-hearing Br. at 11. It argues additionally that the actions taken by Petitioner's staff were confirmed to be appropriate by the residents' treating physicians. Id.

I disagree with these characterizations. The evidence offered by CMS clearly shows that both Residents #s 1 and 5 were at great risk for serious harm or death during the periods of time when Petitioner's staff should have notified their treating physicians, but failed to do so. Both of these residents were in great jeopardy and ultimately required hospitalization. The fact that nothing untoward happened to the residents during those periods is not a basis for concluding that nothing untoward could have happened. The fact is that either of these residents might have died and, consequently, it was of vital importance that each resident's physician be aware of, and involved in, providing care for that resident.

Moreover, I disagree with Petitioner's assertion that actions taken by Petitioner's staff were, in hindsight, found to be appropriate by a physician. While Dr. Rouse stated that administration of Glucagon was medically appropriate for Resident # 1, he also concluded that Petitioner's staff should be reprimanded for failing to notify a physician of Resident # 1's condition on October 30, 2000 "in a more timely fashion." P. Ex. 33, at 2. Also, Dr. Rouse gave no opinion as to when Resident # 5's physician should have been notified or whether it was medically appropriate for the nurse to give the resident nitroglycerin without testing his blood pressure or first calling the physician.

3. From November 17, 2000 through January 11, 2000, Petitioner continued to fail to comply substantially with Medicare participation requirements, albeit at a level of noncompliance that is less than the immediate jeopardy level.

The Arkansas State survey agency and CMS determined that Petitioner abated the immediate jeopardy level deficiencies at its facility on November 17, 2000, by submitting a plan of correction and implementing corrective actions. CMS determined that Petitioner remained out of compliance with participation requirements, at a level of noncompliance that was less than the immediate jeopardy level, between November 17, 2000 and January 11, 2001. CMS determined that Petitioner did not attain full compliance with participation requirements until January 11, 2001.

I sustain CMS's determination that Petitioner did not attain substantial compliance with participation requirements before January 11, 2001. Petitioner has not offered any evidence or argument to prove that, assuming it was not complying substantially with participation requirements as of November 16, 2000, it attained substantial compliance with participation requirements at any time before January 11, 2001.

4. A civil money penalty of $7,500 is a reasonable remedy for Petitioner's failure to comply substantially with participation requirements, at the immediate jeopardy level, on November 16, 2000.

CMS may impose civil money penalties in a range of from $3,050 to $10,000 per day for each day that a facility manifests one or more immediate jeopardy level deficiencies. Here, CMS determined to impose a penalty in the amount of $7,500 for November 16, 2000, the one day on which it determined Petitioner to manifest immediate jeopardy level deficiencies. This amount falls within the authorized penalty range given that Petitioner manifested several immediate jeopardy level deficiencies on that date.

Petitioner had a right to challenge the reasonableness of the amount of the immediate jeopardy level civil money penalty. However, Petitioner offered no argument, either in its pre-hearing or post-hearing briefs, that the penalty amount is unreasonable assuming the presence of an immediate jeopardy level deficiency or deficiencies on November 16, 2000. I sustain the $7,500 civil money penalty in light of that.

Moreover, I find the penalty amount of $7,500 to be reasonable based on evidence which relates to factors that are relevant to deciding the penalty amount.. These factors are set forth in 42 C.F.R. �� 488.438 and 488.404 (incorporated by reference into 42 C.F.R. � 488.438(f)(3)). The factors include a facility's noncompliance history, its financial condition, its culpability, the seriousness of its deficiencies, and the relationship of one deficiency to another.

In this case neither party offered evidence as to Petitioner's compliance history or its financial condition. I make no findings concerning these factors. However, the seriousness of Petitioner's deficiencies on November 16, 2000 is apparent from the evidence pertaining to them. I conclude that the seriousness of the deficiencies was sufficient to justify a civil money penalty of $7,500. The evidence in this case shows that Residents #s 1 and 5 each were placed in life threatening circumstances that were made more dangerous by the errors or omissions of Petitioner's staff. In light of that, a $7,500 civil money penalty clearly is reasonable.

Both Resident # 1 and Resident # 5 experienced medical complications that could easily have led to their deaths. Each of these residents was experiencing a medical emergency. It was critically important that physicians be involved in making the types of care decisions that only physicians would have been qualified to make for these residents. Either resident might have died absent physician involvement in his or her case. Given that, the failure by Petitioner's staff immediately to notify the residents' treating physicians was an egregious error. Moreover, there was a period of time after October 30, 2000 when Resident # 1 potentially was in danger of being attacked by an unknown individual. It is possible that she survived an attempt to injure her or even to kill her on the evening of October 30, 2000. Someone unknown had administered insulin to the resident with apparently malign intent. Petitioner's staff recognized the need to provide the resident with special security but failed to implement the plan that they developed.

5. Civil money penalties of $200 per day are reasonable as remedies for each day of Petitioner's continued noncompliance with participation requirements from November 17, 2000 through January 11, 2001.

Civil money penalties in amounts of from $50 to $3000 per day are authorized as remedies for deficiencies that are substantial but which do not reach the immediate jeopardy level of noncompliance. CMS determined to impose civil money penalties of $200 per day for each day of Petitioner's continued noncompliance with participation requirements during the period which ran from November 17, 2000 through January 11, 2001. These penalty amounts are within the amounts that are authorized for non-immediate jeopardy level deficiencies.

I find these amounts to be reasonable. Petitioner offered neither argument nor evidence to challenge their reasonableness. They are at the lower end of the range of penalties that may be imposed for non-immediate jeopardy level civil money penalties.

6. CMS is authorized to deny Petitioner payment for new Medicare admissions for each day of a period that ran from December 21, 2000 through January 11, 2001.

The remedies that CMS may impose for noncompliance with Medicare participation requirements include denial of payment for new Medicare admissions. 42 C.F.R. �488.406(a)(2). A facility may not challenge CMS's choice of remedies, except that it may challenge the amounts of civil money penalties that CMS determines to impose. Here, I have found that Petitioner was not complying substantially with Medicare participation requirements from November 16, 2000 through January 11, 2001. Given that, CMS was authorized to impose denial of payment for new Medicare admissions for the December 21, 2000 - January 11, 2001 period.

Steven T. Kessel

Administrative Law Judge

1. The staff's administration of nitroglycerin to Resident # 5 also was an alteration in the resident's treatment which triggered an immediate physician consultation requirement. However, it appears that the staff administered this medication to Resident # 5 at about the same time as it notified the physician of the resident's condition and their action.

2. CMS argues that the administration of Glucagon or nitroglycerin without a prior physician's order is a violation of 42 C.F.R. � 483.10(b)(11)(i). I do not agree with this argument. The regulation addresses the obligation of a facility's staff to immediately consult with a physician of changes in a resident's condition or treatment regime. This regulation does not require pre-authorization of changes in treatment where the nurse concludes that a resident's condition requires immediate intervention. I am not suggesting by this conclusion that administering such medications without appropriate physicians' orders would not contravene standards of nursing practice.

3. The previous notification regulations provided:

(10) Notification of changes. (i) Except in a medical emergency or when a resident is incompetent, a facility must consult with the resident immediately and notify the resident's physician, and if known, the resident's legal representative or interested family member within 24 hours when there is-(A) An accident involving the resident which results in injury;(B) A significant change in the resident's physical, mental, or psychosocial status;(C) A need to alter treatment significantly; or(D) A decision to transfer or discharge the resident from the facility as specified in � 483.12(a).

54 Fed. Reg. 5,316, 5,360 (Feb. 2, 1989).

4. Petitioner's investigative report of this incident also reflects that the husband - has previously been suspected of spousal abuse of [Resident # 1] while she was an inpatient at Generations at Washington Regional Medical Center. Connie Vogel, APN, reported that these accusations were reported to the Department of Human Service and that they were unfounded prior to her admission to Kellmark Nursing Center in Rogers, Ar. CMS Ex. 11, at 8.

5. The only reasonable alternative explanation for Resident # 1's condition would be that Petitioner's staff had accidently or maliciously administered insulin to the resident. Since Petitioner concluded, through its own investigation, that its staff did not administer the insulin, then, by process of elimination, it would have had to consider the husband a possible threat to Resident # 1's safety and report the incident to the police. P. Ex. 29, at 9.

6. In the same tag, CMS also found that Petitioner failed to comply with 42 C.F.R. � 483.75(o)(3) which addresses restrictions on the disclosure of the records of a quality assessment and assurance committee. CMS did not cite any facts or offer any arguments which would tend to show that Petitioner violated this subsection, so I regard this citation as an oversight.