SUBJECT:

Royal Manor

Petitioner,

Centers for Medicare & Medicaid Services.

DECISION

I sustain the imposition of civil money penalties of $7,500 per day against Petitioner, Royal Manor, for a period consisting of May 14 - 16, 2002. The total amount of civil money penalties that I sustain is $22,500.

I. Background

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

A survey was conducted of Petitioner's facility on May 13 - 14, 2002 (survey) by the Kentucky Cabinet for Health Services - Division of Long Term Care (survey agency) in response to a complaint that Petitioner was not providing care required by law. The survey agency made noncompliance findings. These noncompliance findings included a finding that Petitioner was derelict in providing care to its residents as is required by 42 C.F.R. � 483.25 to the extent that residents were placed in a state of immediate jeopardy. The Centers for Medicare & Medicaid Services (CMS) accepted this finding and CMS determined to impose against Petitioner the civil money penalties that are at issue here. ⁽¹⁾

Petitioner challenged CMS's determination and requested a hearing before an administrative law judge. I was assigned to hear and decide the case. I held an in-person hearing in Lexington, Kentucky, on January 13, 2004. At the hearing I received into evidence from CMS exhibits consisting of CMS Ex. 1 - CMS Ex. 28. I received into evidence from Petitioner exhibits consisting of P. Ex. 1 - P. Ex. 17. I declined to receive into evidence an exhibit which I identified as P. Ex. 18. I afforded the parties the opportunity to submit, and the parties submitted, post-hearing briefs and reply briefs.

II. Issues, findings of fact and conclusions of law

A. Issues

The issues in this case are whether:

1. Petitioner manifested an immediate jeopardy level failure to comply with the requirements of 42 C.F.R. � 483.25 during the period that ran from May 14 - May 16, 2002.

2. Civil money penalties of $10,000 per day for each day of the May 14 - 16, 2002 period are a reasonable remedy.

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 separately numbered heading. I discuss each Finding in detail.

1. Petitioner manifested an immediate jeopardy level failure to comply with the requirements of 42 C.F.R. � 483.25 during the period that ran from May 14 - May 16, 2002.

42 C.F.R. � 483.25 requires a skilled nursing facility to provide each of its residents with the necessary care and services to attain or maintain the highest practicable level of physical, mental, and psychosocial well-being, in accordance with each resident's comprehensive assessment and plan of care. CMS alleges that Petitioner was not complying with the requirements of this regulation to the extent that residents were placed in immediate jeopardy. According to CMS, the way in which Petitioner's staff dealt with one resident's episode of respiratory distress demonstrates that Petitioner and its staff were incapable of responding competently to an emergency of that nature. CMS bases its assertion of immediate jeopardy level noncompliance on the following specific allegations:

� Petitioner's staff wasted time before providing emergency resuscitation to a resident who was in respiratory distress, thereby endangering the life of the resident.

� Petitioner's staff displayed a lack of knowledge of the requisite techniques for performing cardiopulmonary resuscitation (CPR) and failed to perform CPR appropriately in an emergency situation where correct use of CPR might have saved a resident's life.

� Petitioner failed to maintain in proper working order suctioning equipment, necessary for clearing a resident's occluded airway, and failed to suction the airway of a resident who was aspirating, thereby endangering the resident's life.

� Petitioner's staff failed to provide necessary information to emergency medical services (EMS) who responded to a summons for emergency care at Petitioner's facility, thereby potentially endangering a resident's life.

These allegations all relate to the care that Petitioner's staff gave on May 6, 2002 to a resident who is identified as Resident # 1 in the survey report. CMS Ex. 2. On that date Resident # 1 expired while at Petitioner's facility. The cause of death was complications from aspiration. The resident choked to death from fluids that she vomited and then inhaled.

The prima facie evidence offered by CMS concerning the circumstances surrounding the death of Resident # 1 includes: signed statements of Petitioner's employees that were obtained by survey agency surveyors on May 13, 2002; the sworn declaration of an EMS technician; and additional supporting exhibits. The evidence describes Resident # 1's distress, the efforts made on her behalf by Petitioner's staff, and her death. The facts which emerge from this evidence are as follows:

� Resident # 1's care plan noted the resident to be at risk for aspiration, including labored breathing, coughing, or choking. CMS Ex. 3 at 6 - 7, 9 - 10.

� On the evening of May 6, 2002, at about 9:20 p.m., Roy Burnett, a certified nursing assistant who was employed by Petitioner, responded to a call light that signaled a need for assistance in Resident # 1's room. CMS Ex. 3 at 13; CMS Ex. 6 at 3. The request for assistance was made by the roommate of Resident # 1.

� Upon entering Resident # 1's room, Mr. Burnett observed that Resident # 1 was lying in her bed with the head of the bed elevated. The resident had vomited dark brown or black material on herself and on her bed. CMS Ex. 6 at 3. Mr. Burnett immediately left to seek help. Id. He returned to the room after about 30 seconds and noticed that the resident was making a gurgling sound. Id. The resident's color had changed - she was paler - and her level of awareness had decreased. Id.

� Certified nursing assistant Vivian Thomas was attending to another resident in a room across the hall from Resident # 1's room at the time that Mr. Burnett initially responded to the call light in Resident # 1's room. CMS Ex. 6 at 21. She went to Resident # 1's room to assist Mr. Burnett.

� Licensed practical nurse Donna Edwards entered Resident # 1's room after about a minute had elapsed from the time that Mr. Burnett returned to the resident's room after seeking assistance. CMS Ex. 6 at 3. Ms. Edwards was assigned to provide care to Resident # 1 on the evening of May 6, 2002. Id. at 17. Ms. Edwards, upon observing the resident, stated that the resident had aspirated and that it was necessary to implement a "code" for Resident # 1. Id. at 3.

� A "code" is an emergency. When a code is announced for a resident it means that staff attending to the resident will perform life-saving or resuscitative measures, including CPR, for the resident. CMS Ex. 22 at 2.

� Ms. Edwards used Petitioner's intercom system to announce a code for Resident # 1. CMS Ex. 6 at 3. In response, licensed practical nurse Jean Couch entered the resident's room. CMS Ex. 6 at 3. Ms. Couch inquired whether the resident had a "do not resuscitate" (DNR) order in her chart or whether the resident was a "full code" (use all possible means to resuscitate) status resident. Id.

� Another licensed practical nurse, Denise Vangberge, went to Petitioner's nurses' station in order to retrieve Resident # 1's chart. CMS Ex. 6 at 3. After Ms. Vanberge returned with the chart, the nurses discussed whether or not Resident # 1 had a DNR order or whether she had full code status. Id. at 3.

� About two or three minutes elapsed from the time that Ms. Vanberge went to the nurses' station to retrieve Resident # 1's chart to the completion of the discussion as to the resident's status. CMS Ex. 6 at 3. The nurses determined that the resident had a full code status. Id.

� The nurses spent several minutes after they had determined that Resident # 1 had a full code status discussing what measures should be taken to assist the resident. Ms. Vanberge went to retrieve a crash cart. CMS Ex. 6 at 3, 10. Ms.Vanberge also made a call to 911 for EMS assistance at 9:27 p.m. Id. at 10; CMS Ex. 25 at 5.

� A "crash cart" is a cart which contains equipment that is used to perform resuscitation on an individual who is in distress, including respiratory distress. CMS Ex. 22 at 2. The equipment typically put on a crash cart includes: a suction machine used to clear a resident's airway when it is obstructed; an Ambu-Bag and a mask used to administer artificial respiration to a resident who is in respiratory distress; and a CPR board used to provide a flat and hard surface beneath a resident who requires chest compressions to pump blood through his or her circulatory system. Id.

� After retrieving the crash cart Ms. Vanberge attempted to assemble the suction machine. CMS Ex. 6 at 3, 10. However, a hose seemed to be missing from the machine. Ids. Consequently, the resident was not suctioned. Ids.; CMS Ex. 6 at 17.

� Ms. Couch hooked up the Ambu-Bag and asked Mr. Burnett to operate it. CMS Ex. 6 at 3. He did so at Ms. Couch's direction. Id.

� Ms. Couch then started to perform CPR on Resident # 1. CMS Ex. 6 at 3. The head of the bed, which was at a 45 degree angle to the bed, was not lowered. Id. at 3, 10. The CPR board was not placed under the resident. Id. at 10.

� During the CPR attempt Resident # 1 vomited extremely dark black or brown material from her nose and mouth. CMS Ex. 6 at 3, 10.

� After making a very brief effort at CPR, Ms. Couch announced that further efforts would be of no use and attempts at performing CPR were abandoned. CMS Ex. 6 at 3, 10, 17. ⁽²⁾

� A short time later Mr. Burnett and Ms. Thomas turned Resident # 1 on her side. A large quantity of fluid which resembled coffee grounds poured from the resident's mouth. CMS Ex. 6 at 6.

� EMS personnel arrived at 9:31 p.m. CMS Ex. 25 at 5. Resident # 1 was observed to be lying in bed. The resident had no pulse, was not breathing, and was ashen colored. CMS Ex. 25 at 2.

� Two of Petitioner's staff members were in the room with Resident # 1 at the time that the EMS personnel arrived. CMS Ex. 25 at 2. The staff was not administering CPR or any other life saving measures to the Resident at the time of the EMS personnel's arrival. Id. The staff members told the EMS personnel that they had found Resident # 1 to be dead in her room, that the resident had been dead for an unknown length of time, and that they had not initiated CPR on Resident # 1. Id. at 2, 6.

� The EMS personnel elected not to initiate life saving measures for Resident # 1. That determination was based, in part, on the staff's telling the EMS personnel that the resident was found dead and that CPR had not been initiated. CMS Ex. 25 at 2. Had the EMS personnel known that Petitioner's staff had attempted to perform CPR, then the EMS personnel would have specifically asked about Resident # 1's response to CPR and the time when CPR was stopped. The staff's answers to those questions might have affected the EMS personnel's judgment as to whether life saving measures should have been initiated. Id. at 2 - 3.

This prima facie evidence describes a gross failure by Petitioner to provide necessary emergency resuscitation services to Resident # 1. First, it shows that Petitioner's staff wasted precious time deciding what to do for Resident # 1. Minutes were lost while the staff attempted to determine whether the resident was a DNR resident or was a full code resident. The staff wasted more time after the resident's resuscitation status was established while employees debated what to do for Resident # 1.

Second, the prima facie evidence establishes that the staff made a haphazard and incompetent attempt to resuscitate Resident # 1. Professionally recognized standards of nursing care require staff to clear a patient's airway before attempting to perform CPR and to keep the airway clear while CPR is underway. CMS Ex. 22 at 16, 18; CMS Ex. 23 at 3, 12, 13 - 14. There was an obvious obstruction in Resident # 1's airway: fluid poured from her nose and mouth when the staff attempted to perform chest compressions and when the resident was turned on her side. But, the prima facie evidence is that staff did not suction the resident or otherwise clear her airway.

Professionally recognized standards of nursing also require that, in order to be effective, CPR must be performed with the patient prone and with a hard surface under the patient's back. CMS Ex. 22 at 17 - 18; CMS Ex. 23 at 13; CMS Ex. 26 at 6. If the patient is not prone there is a likelihood that aspirated substances will be re-ingested into the patient's lungs while chest compressions are performed. If a hard surface is not placed under the patient's back there is a likelihood that chest compressions will not be effective. In this case the prima facie evidence shows that Petitioner failed to heed these requirements. CPR was attempted on Resident # 1 while her upper body was elevated at a 45 degree angle. A CPR board was not placed under the resident.

Professionally recognized standards of nursing care require additionally that, once initiated, CPR should not be abandoned until the care giver receives instructions by a physician to discontinue CPR. CMS Ex. 22 at 19. In this case, CPR was abandoned after only brief efforts, at the insistence of Ms. Couch, who is not a physician.

Third, the prima facie evidence shows that Petitioner failed to maintain in working order equipment that is essential to providing emergency care to a resident with an obstructed airway. Alternatively, the evidence shows that Petitioner's staff was not versed in that equipment's use. The suctioning equipment either was missing a vital part or Petitioner's staff did not know how to assemble the equipment. In either event, the prima facie evidence establishes that Petitioner's staff was unable to utilize equipment that was absolutely necessary to saving Resident # 1's life.

Finally, the evidence that was introduced by CMS shows that Petitioner's staff gave false information to the EMS personnel who arrived to provide care to Resident # 1. The EMS personnel elected not to provide resuscitation to Resident # 1 based on Petitioner's staff's telling them that the resident had been found dead in her room and that CPR had not been attempted. This information clearly was incorrect.

The term "immediate jeopardy" is defined at 42 C.F.R. � 488.301 to be:

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.

The prima facie evidence strongly supports a finding of an immediate jeopardy level deficiency. It is not certain that Resident # 1 would have been helped by competent attempts at resuscitation. Indeed, the evidence does not clearly establish at what point Resident # 1 expired. But, that is beside the point. The prima facie evidence offered by CMS establishes a manifest failure by the staff to comprehend its duties to a resident in distress and to perform resuscitation competently.

The possibility that Resident # 1 might have survived had she received appropriate care was extinguished by the staff's incompetence. It is also proof that all of Petitioner's residents were in jeopardy. The potential for extremely harmful or lethal consequences for Petitioner's residents existed so long as Petitioner's staff was not trained to provide effective resuscitation to the frail and sick population that was under the staff's care and so long as Petitioner failed to maintain emergency equipment in proper working order.

Petitioner's principal argument in response to CMS's prima facie case is that Resident # 1 expired before nursing staff could attend to her. According to Petitioner resuscitation was unnecessary and, indeed, not attempted. I find Petitioner's contentions largely to be irrelevant. In significant respects they are not supported by the credible evidence. Moreover, Petitioner has not rebutted the most damaging facts of CMS's case.

The evidence in this case does not establish the precise moment of Resident # 1's death. But, the precise moment of her death is unimportant to my decision. What is clear from the evidence is that Petitioner's staff treated the resident's case as being that of a resident in distress and the staff's initial assessment prompted an effort at resuscitation. The incompetence of that effort is the basis for my finding of an immediate jeopardy level deficiency.

Furthermore, I do not find to be credible Petitioner's contention that its staff never attempted to resuscitate Resident # 1. To support this contention Petitioner relies on a nursing note that Ms. Couch wrote and signed on the evening of May 6, 2002. ⁽³⁾ Petitioner's post-hearing brief at 2; P. Ex. 1 at 1. In her note, Ms. Couch avers that when she entered Resident # 1's room, the resident was pulseless without any sign of life. P. Ex. 1 at 1. The note states additionally that the resident's eyes were rolled back in her head and that a three lead electrocardiogram (EKG) showed a "straight line" (meaning no heartbeat). Id. The note makes no mention of Mr. Burnett's observations of the resident or of the observations made by other nurses before Ms. Couch entered the resident's room. It omits mentioning the staff's discussion about whether the resident was a DNR resident or a full code resident. There is no discussion in the note of efforts to obtain a crash cart or to assemble suction equipment. Nor does it refer to any efforts to resuscitate Resident # 1.

Reading the note in a vacuum one certainly would never know that attempts at resuscitation were made. Notwithstanding, the weight of the evidence - including Petitioner's own evidence - establishes that Petitioner's staff attempted to resuscitate Resident # 1. The failure of the note to mention resuscitation is contradicted, not only by the statements that the surveyors obtained, and which I discuss in detail above, but by statements given by Ms. Couch to Petitioner's management within a day or two of the events of May 6, 2002.

Ms. Couch issued two statements to Jason P. Faith, R.N., Petitioner's Regional Clinical Director, which include information that is not contained in her nursing note. In these statements she describes efforts that she and other staff members made to resuscitate Resident # 1. P. Ex. 16 at 12 - 13, 20 - 21. In a telephone interview conducted on May 8, 2002, Ms. Couch acknowledges that a crash cart was brought into the resident's room. P. Ex. 16 at 13. She acknowledges also that she began chest compressions on Resident # 1 while Mr. Burnett employed an Ambu-Bag on the resident. Id.

When questioned as to why she did not suction the resident's airway Ms. Couch asserted that she did not have suction equipment available to her. Id. In an undated handwritten statement made to Mr. Faith, Ms. Couch asserted that there was an "unsuccessful attempt for CPR & was stopped 911 arrived." P. Ex. 16 at 20.

The evidence that Petitioner offered does not contradict any of the prima facie evidence introduced by CMS that shows that Petitioner's staff's efforts at resuscitation were performed incompetently. It is this unrefuted prima facie evidence which forms the critical mass of CMS's case. Specifically, Petitioner did not offer any evidence which challenges the following elements of CMS's prima facie case:

� Petitioner's staff delayed attempting to resuscitate Resident # 1 for several minutes while it attempted to ascertain the contents of the resident's resuscitation order and then debated what actions to take on the resident's behalf.

� The suctioning equipment either lacked a necessary part or Petitioner's staff was unable to assemble it.

� The resident's airway was blocked but Petitioner's staff failed to suction her.

� CPR was attempted with the resident's upper body elevated at a 45 degree angle to her bed and without a CPR board being placed under the resident's body.

� Efforts at CPR were abandoned after a brief period.

� The staff failed to give EMS personnel an accurate accounting of what they had observed or what they had attempted to do.

CMS determined the duration of Petitioner's noncompliance to have been from May 14, 2002, the date of completion of the survey, until May 16, 2002 when Petitioner submitted a plan of correction. Petitioner has not offered evidence to show that it completely corrected its deficiency at a date that is earlier than May 16, 2002. Consequently, I sustain CMS's determination as to duration.

2. Civil money penalties of $10,000 per day for each day of the May 14 - 16, 2002 period are not reasonable. Civil money penalties of $7,500 per day for each day of the period are reasonable.

Civil money penalties in a range of between $3,050 and $10,000 may be imposed against a facility for each day that the facility manifests an immediate jeopardy level deficiency. 42 C.F.R. � 488.438(a)(i). In this case CMS determined to impose against Petitioner the maximum penalties of $10,000 for each day of the May 14 - May 16, 2002 period. The question is whether such penalties are reasonable given the circumstances of this case.

"Reasonableness" is measured by factors that are stated at 42 C.F.R. �� 488.438(f) and 488.404 (incorporated by reference into 42 C.F.R. � 488.438(f)(3)). These factors include: the seriousness of a facility's deficiency or deficiencies; the deficiencies' interrelationship; a facility's compliance history; its culpability; and its financial condition.

A hearing before an administrative law judge is a de novo hearing. I am not bound by CMS's determination. Nor is my job to review only the factors that were considered by CMS in determining the amount of penalties and to decide whether CMS acted reasonably. Rather, I must look at the evidence that relates to any regulatory factors which may be addressed by the evidence independently from CMS and decide what that evidence says, objectively, about the facility's compliance and the need for a remedy.

In doing that I do not employ a mechanical approach. The number of factors that are present in a case may not necessarily point to a particular penalty amount. If the evidence that relates to even one regulatory factor is sufficiently strong to support a remedy that may be all that is necessary to decide what is reasonable. That is particularly the case if the facility's noncompliance is extremely serious.

Furthermore, what is an appropriate remedy in a particular case should not be decided based on what may or may have not been done in another case. Remedy decisions in other cases are not precedent although a consistent approach to deciding what is remedial is appropriate.

CMS asserts that penalties of $10,000 per day are justified based on the seriousness of the deficiency in this case and on Petitioner's culpability for that deficiency. The deficiency in this case certainly was extremely serious. The sole purpose of Petitioner's existence is to provide care and support to those individuals who are so sick or so frail as to be incapable of caring for themselves.

The people who reside in Petitioner's facility - indeed, in any skilled nursing facility - are by definition so sick as to be helpless when it comes to providing for their own medical care. Petitioner knew that its residents were utterly dependent on it for their care and well-being. Yet, Petitioner failed to provide its residents with necessary emergency equipment or with staff that was competently trained in a basic life-saving procedure.

Moreover, the evidence supports the conclusion that these shortcomings were a consequence of Petitioner's indifference to basic life-saving measures. A competently operated facility would have made sure that the equipment on its crash carts was well maintained and that staff new how to use that equipment. And, a competently operated facility would have made certain that its staff was so well versed in basic life-saving techniques that it could provide them even under the pressure of an emergency. Petitioner did not do that in this case. It neglected the needs of Resident # 1. But, more importantly, in neglecting the needs of Resident # 1 it demonstrated that there were woeful inadequacies present in its overall approach to residents' welfare.

Petitioner argues that the surveyors attached only the lowest level of scope and severity within the immediate jeopardy range to the deficiency that is at issue here. But, assuming that to be true, it is obvious that CMS implicitly overruled this finding - as it was authorized to do - by determining to impose the maximum allowable immediate jeopardy level penalty amount.

If the evidence relied on by CMS were the only evidence relating to remedy I would sustain civil money penalties at or approaching the maximum amount. The seriousness of Petitioner's deficiencies as of May 6, 2002 is so egregious as to warrant them. However, the evidence offered by Petitioner shows that it had already begun to implement corrective actions by May 14, 2002, the first day of the remedy period. These actions mitigate Petitioner's culpability for its noncompliance during this period and I am modifying the civil money penalties to take into consideration Petitioner's reduced culpability during the May 14 - 16, 2002 period.

Although I do not find that Petitioner had eliminated its immediate jeopardy level deficiency by May 14, 2002, I do find that it had begun to take steps as of that date to eliminate it.

As a consequence, Petitioner's culpability was significantly reduced as of May 14, 2002. As Petitioner notes, it began to implement remedial action immediately after the events of May 6, 2002. By May 8, 2002 it conducted an in-house investigation of the events of May 6. P. Ex 13. Petitioner's internal documents show that, prior to May 14, 2002, its management recognized the existence of a serious problem. P. Ex. 13.

On May 7, 2002, Petitioner conducted in-service training which included a basic review of CPR techniques and safety issues. P. Ex. 14. On May 8 and 9, 2002, Petitioner took disciplinary action against the nursing staff who were involved in the episode of May 6.

The $7,500 per day civil money penalties that I sustain in this case thus reflect the seriousness of Petitioner's deficiencies.

But, they also reflect that Petitioner had demonstrated awareness of its deficiencies by May 14, 2002 and had begun, if not completed, efforts to rectify them by that date. ⁽⁴⁾

Steven T. Kessel

Administrative Law Judge

1. The survey agency originally made two findings of noncompliance. After an independent dispute resolution (IDR) proceeding the survey agency deleted its second finding of noncompliance and reduced the scope and severity of the finding of noncompliance with 42 C.F.R. � 483.25 to less than immediate jeopardy. CMS accepted in part and rejected in part the IDR outcome. It accepted the deletion of the additional finding of noncompliance. CMS overruled the finding concerning the scope and severity of Petitioner's failure to comply with the requirements of 42 C.F.R. � 483.25 and, in so doing, reinstated the immediate jeopardy level deficiency finding.

2. The evidence does not clearly state how many chest compressions were made or for how long the staff attempted to perform CPR before efforts were abandoned. For example, Mr. Burnett estimates that Ms. Couch performed 15 compressions and that CPR lasted, in total, about 45 seconds. CMS Ex. 6 at 3. Ms. Edwards avers that Ms. Couch performed "a few" chest compressions. Id. at 17. However, the witnesses are consistent in stating that whatever efforts were made at CPR they were brief and ineffectual and did not involve lowering the head of Resident # 1's bed or placing a CPR board under the resident. Id. at 17.

3. The note is recorded at 9:25 p.m. on the evening of May 6, 2002. That time clearly is not correct. The body of the note refers to "911 paged & here @ 9:26 p." P. Ex. 1 at 1. In other words, the alleged time that the note was written is earlier than time-sensitive information that is recorded in the note.

4. It is puzzling why CMS opted to find that the immediate jeopardy level deficiency began on May 14, 2002 and not on May 6, 2002. The evidence certainly supports a conclusion that the deficiency was present on May 6, given that this was the date of Resident # 1's respiratory distress and death. Moreover, Petitioner's culpability was much higher as of May 6, and extending through at least May 8, than it was on May 14, 2002. I almost certainly would have sustained civil money penalties at a higher amount than $7,500 per day for the period that began on May 6, 2002 and which ran through May 8, 2002 had CMS determined to impose them for that period. But, CMS did not determine to do so and I do not consider it appropriate in this case to address that issue on my own motion.