SUBJECT:

Britthaven of Goldsboro,

Petitioner,

Centers for Medicare & Medicaid Services.

DECISION

I sustain the revised determination of the Centers for Medicare & Medicaid Services (CMS) to impose civil money penalties against Petitioner, Britthaven of Goldsboro, in amounts of $5,000 per day for each day of a period that began on July 21, 2002, and which ran until August 13, 2002.

I. Background and Procedural History

Petitioner is a skilled nursing facility that is located in Goldsboro, North Carolina. It participates in the Medicare program. Its participation in that program is governed by sections 1819 and 1866 of the Social Security Act (Act) and by federal regulations at 42 C.F.R. Parts 483 and 488. The regulations which govern the hearing in this case are set forth at 42 C.F.R. Part 498.

Petitioner was surveyed for compliance with federal participation requirements on August 14, 2002 (August 2002 survey) by surveyors employed by the North Carolina Department of Health and Human Services. The surveyors concluded that, effective July 21, 2002, Petitioner was not complying substantially with two participation requirements and that the level of Petitioner's noncompliance with these two requirements was such that residents of Petitioner's facility were in a state of immediate jeopardy. CMS concurred with these findings. Initially, CMS determined that the appropriate remedy for Petitioner's two alleged deficiencies was to impose two per instance civil money penalties of $5,000 against Petitioner, for a total of $10,000 in penalties.

Petitioner requested a hearing and the case was assigned to me for a hearing and a decision. On December 9, 2002, I issued an initial prehearing order in this case. The order instructed the parties to make prehearing exchanges of proposed exhibits including proposed written direct testimony and to file prehearing briefs which addressed every issue of fact and law. The parties complied with this order and I scheduled a hearing to take place on November 12, 2003.

On August 8, 2003, CMS issued a notice of a revised determination to Petitioner. The revised determination made no changes in the allegations of noncompliance as of July 21, 2002. However, CMS asserted that Petitioner's alleged noncompliance continued until August 13, 2002. CMS determined that, instead of imposing the two per instance $5,000 civil money penalties against Petitioner, it would impose civil money penalties of $5,000 per day against Petitioner for each day of a period that ran from July 21, 2002 until August 13, 2002. In doing so, CMS raised two new issues that had not been included in its original determination. These were: the duration of Petitioner's alleged noncompliance; and the reasonableness of the $5,000 per day proposed civil money penalties.

I held a prehearing conference on August 29, 2003. I granted Petitioner leave to file an amended hearing request, prehearing brief, and additional exhibits and testimony to address the two new issues raised by CMS in its redetermination. I also granted CMS leave to file an amended prehearing exchange to address any new issues that Petitioner might raise by its amended hearing request or supplemental submission. Finally, I advised the parties that the hearing would be held on November 12, 2003 as originally scheduled.

Petitioner then moved, on September 23, 2003, to strike CMS's revised determination. During the pendency of this motion, Petitioner filed an amended hearing request, an amended prehearing brief, and additional proposed evidence (October 1, 2003). CMS responded to Petitioner's motion to strike on September 30, 2003. Additionally, it moved to supplement its prehearing exchange. Petitioner filed a reply to CMS's response to the motion to strike (October 14, 2003). Petitioner then filed an opposition to CMS's motion for leave to file an amended prehearing exchange on October 16, 2003. I granted a request by CMS for leave to file an additional argument relating to the motion to strike, which was submitted on October 22, 2003.

I issued a ruling on October 28, 2003 denying Petitioner's motion to strike CMS's revised determination. In that ruling, I held that CMS was authorized to issue a redetermination pursuant to the provisions of 42 C.F.R. § 498.32. ⁽¹⁾ I also granted CMS leave to file its proposed amended prehearing exchange, which was filed on October 1, 2003 and included additional exhibits designated by CMS as CMS Exhibits (CMS Exs.) 16, 17, and 18.

Petitioner then moved that I continue the November 12, 2003 hearing. It argued that the new issues raised by CMS in its revised determination greatly expanded the scope of the case, and that Petitioner's counsel and its proposed witnesses would need additional time to review the record and to prepare for the hearing. CMS objected to Petitioner's motion for continuance on October 30, 2003. I denied this motion on October 31, 2003. On that same day, Petitioner filed a waiver of its request for an in-person hearing. I issued a schedule for the parties to file briefs addressing the issues in the case. Additionally, I directed that Petitioner shall be provided the opportunity to file objections to CMS's exhibits, especially those which CMS submitted as part of its supplemental exchange.

The parties then filed briefs. CMS filed a brief which it entitled Centers for Medicare & Medicaid Services' Brief in Support of Affirmance of Revised Determination (CMS's brief). Petitioner filed documents which it entitled Petitioner's Opening Brief (Petitioner's brief) and Petitioner's Motion Objecting to Respondent's Exhibits (Petitioner's motion). Petitioner attached an additional proposed exhibit (Petitioner's Exhibit 30) to its brief. In its motion, Petitioner filed specific objections to two of the supplemental exhibits submitted by CMS. CMS then filed responses to Petitioner's brief and to Petitioner's objections. Additionally, CMS objected to my receiving into evidence Petitioner's Exhibit (P. Ex.) 30. Petitioner then filed a motion for leave to file a reply to CMS's response brief and to reply to CMS's objections to P. Ex. 30. CMS opposed this motion. I granted Petitioner's request and its reply brief was submitted on October 14, 2003.

II. Rulings as to Admission of Exhibits

CMS submitted a total of 18 proposed exhibits (CMS Ex. 1 - CMS Ex. 18). It submitted CMS Ex. 16, CMS Ex. 17, and CMS Ex. 18 as supplemental exhibits. Petitioner objects to my receiving portions of CMS Ex. 14 and CMS Ex. 15 into evidence. Petitioner also objects to my receiving CMS Ex. 17 and CMS Ex. 18 into evidence. Petitioner submitted 29 proposed exhibits with its initial and amended prehearing exchanges (P. Ex. 1 - P. Ex. 29). Petitioner submitted an additional exhibit (P. Ex. 30) as an attachment to Petitioner's brief and CMS objects to my receiving this exhibit into evidence.

I overrule Petitioner's objections. I receive into evidence CMS Ex. 1 - CMS Ex. 18. I receive into evidence P. Ex. 1 - P. Ex. 29. I am exercising my discretion to receive P. Ex. 30 into evidence despite the fact that CMS's objections to my receiving the exhibit are well-founded. My rationale for these rulings is as follows:

A. CMS Ex. 1 - CMS Ex. 13, CMS Ex. 16, and P. Ex. 1 - P. Ex. 29

I receive CMS Ex. 1 - CMS Ex. 13, CMS Ex. 16, and P. Ex. 1 - P. Ex. 29 into evidence inasmuch as neither party objected to my receiving these exhibits.

B. CMS Ex. 14 and CMS Ex. 15

Petitioner objects to my receiving portions of CMS Ex. 14 and CMS Ex. 15 into evidence on the ground that they contain irrelevant, extraneous, and/or prejudicial information. I overrule these objections. CMS Ex. 14 is the declaration of a registered nurse who is employed by the North Carolina Department of Health and Human Services. Much of the exhibit, including the challenged portions, consists of either her opinions of the quality of care provided by Petitioner in this case or of the obligations and duties of Petitioner's staff. The witness is qualified to offer her opinions and they appear to be relevant to the issues in this case. CMS Ex. 15 is a declaration by the youngest daughter of the resident whose care is at issue in this case. The declarant also is a registered nurse. The challenged portions of the exhibit include a mixture of statements of fact and opinion by the declarant. Aspects of these statements and opinions are relevant. For example, paragraph four of the declaration contains a statement averring that, in the opinion of the declarant, the care offered by Petitioner to her father failed to satisfy the applicable standard of care in several respects. CMS Ex. 15, at 2. Other aspects of the declaration - as in paragraph five, for example - appear to be of tangential relevance at best. But, none of these statements is so prejudicial to Petitioner as to justify exclusion.

As I have often observed, an administrative hearing is not a jury trial and there is consequently no possibility that a jury of lay persons will be influenced by an irrelevant or prejudicial document. Consequently, objections on the grounds of relevance or prejudice carry much less weight in these proceedings than they might in a federal jury trial conducted pursuant to the Federal Rules of Evidence. I reserve the right to not rely on or cite any part of an exhibit that I find to be irrelevant or prejudicial.

C. CMS Ex. 17 and CMS Ex. 18

Petitioner objects to my receiving into evidence CMS Ex. 17 and CMS Ex. 18. It asserts that these exhibits should be excluded because, at the prehearing conference of August 29, 2003, counsel for CMS allegedly averred that she had no additional substantive evidence to offer relative to CMS's allegations of noncompliance. Additionally, Petitioner contends that the two exhibits lack credibility and are unduly prejudicial.

The two exhibits are the curriculum vitae of Peter K. Vaitkevicius, M.D. (CMS Ex.17) and his written declaration (CMS Ex. 18). I overrule Petitioner's objections to the admission of these two exhibits. I agree with Petitioner that these two exhibits - and in particular, CMS Ex. 18 - contain substantive evidence in the form of opinions relevant to the issues of whether Petitioner complied with participation requirements and to the level of its noncompliance which was not offered by CMS as part of its initial prehearing exchange. However, and as I discuss in some detail below, Dr. Vaitkevicius' testimony is credible, particularly as to the issue of whether Petitioner's deficiencies put residents of Petitioner at immediate jeopardy. Petitioner is not prejudiced by my receiving these exhibits into evidence. CMS submitted them on October 10, 2003, more than a month prior to the scheduled hearing date. Petitioner, thus, had ample time to prepare a cross-examination of Dr. Vaitkevicius - which it ultimately opted not to do - or to supplement its prehearing exchange to respond to Dr. Vaitkevicius' testimony.

D. P. Ex. 30

Petitioner submitted P. Ex. 30 as an attachment to its brief filed on December 1, 2003. The exhibit consists of the written declaration of Bonnie Ard, R.N., who has been a facility nurse consultant for Petitioner or its parent corporation since 2002. In her declaration, Ms. Ard addresses the issue of the duration of Petitioner's noncompliance (if noncompliance existed) and asserts, in effect, that Petitioner was compliant between July 21 and August 14, 2002. See P. Ex. 30.

The exhibit addresses one of the two new issues in this case raised by CMS's August 8, 2003 revised determination. At the prehearing conference of August 29, 2003, I gave Petitioner until October 1, 2003 to amend its hearing request and to supplement its prehearing exchange. The purpose of that extension was to give Petitioner the opportunity to submit relevant evidence addressing the new issues.

Petitioner's submission of P. Ex. 30 clearly is untimely. Petitioner submitted it more than two months after the deadline I set for submission of additional evidence by Petitioner. Petitioner has not offered any explanation for its untimely submission of the exhibit. However, I am electing to receive the exhibit into evidence in order to assure that Petitioner's arguments and contentions are articulated completely.

III. Issues, Findings of Fact and Conclusions of Law

A. Issues

The issues in this case are:

1. Did Petitioner fail to comply substantially with Medicare participation requirements effective July 21, 2002;

2. Assuming Petitioner's noncompliance as of July 21, 2002, was CMS's determination that the noncompliance was at the immediate jeopardy level clearly erroneous;

3. Did Petitioner remain noncompliant at the immediate jeopardy level until August 13, 2002; and

4. Is it reasonable to impose civil money penalties of $5,000 per day for each day of Petitioner's noncompliance?

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 as a separate heading.

1. Effective July 21, 2002, Petitioner failed to comply substantially with Medicare participation requirements.

The surveyors who conducted the August 2002 survey concluded that Petitioner was not complying substantially with two participation requirements. These requirements are specified at 42 C.F.R. §§ 483.10(b)(11) and 483.25. I find that CMS established a prima facie case of noncompliance by Petitioner with each of these two regulations which Petitioner did not overcome by the preponderance of the evidence.

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

The Medicare participation requirement at 42 C.F.R. § 483.10(b)(11) instructs a skilled nursing facility as to whom it must notify, and when, if there are significant changes in a resident's clinical condition. Among other things, it requires that a facility immediately notify a resident's physician if there is: a significant change in the resident's physical, mental, or psychosocial status (defined as a deterioration in the resident's health, mental, or psychosocial status in either life-threatening conditions or clinical complications).

CMS bases its allegation, that Petitioner failed to comply with the physician notification requirement of the regulation, on the care that Petitioner gave to a resident who is identified in the August 2002 survey report as Resident # 1. CMS Ex. 3, at 1 - 6. CMS asserts that, on July 21, 2002, this resident sustained acute and significant cardiopulmonary changes. Yet, according to CMS, Petitioner's staff delayed notifying the resident's physician of these changes for more than an hour. The facts which are the basis for the allegations of noncompliance are as follows:

• Resident # 1 was admitted to Petitioner's facility on July 18, 2002 for a short-term rehabilitation stay. CMS Ex. 3, at 1 - 2. The resident was diagnosed to be suffering from illnesses which included, among other things: pneumonia, chest pain secondary to coronary artery disease, and congestive heart failure. Id.

• On admission to Petitioner's facility, Resident # 1 was receiving continuous nasal oxygen at the rate of three liters per minute. CMS Ex. 4, at 25. The resident's physician ordered that Resident # 1 be given oxygen sufficient to maintain a blood oxygen saturation level above 92 percent. Id. at 13. The physician instructed Petitioner's staff to notify him if the resident required more than six liters of oxygen per minute to maintain an acceptable blood oxygen saturation level. Id.

• Between July 18 and July 20, 2002, Resident # 1 received nasal oxygen and his blood oxygen saturation levels remained consistently between 92 and 98 percent. CMS Ex. 4, at 25 - 26. During this period, the resident's vital signs remained normal. Id. The resident was observed to be alert and not to show signs of distress. Id.

• On July 20, 2002, the resident's physician discontinued continuous administration of oxygen to the resident. CMS Ex. 4, at 7. The physician prescribed administration of oxygen at the rate of one and one-half liters per minute to the resident if his blood oxygen saturation level fell below 92 percent. Id. From the point of discontinuation of continuous oxygen on July 20, 2002 until early in the morning of July 21, 2002, the resident's blood oxygen saturation level remained above 90 percent. Id. at 26 - 27.

• At about 7:15 on the morning of July 21, 2002, a certified nursing assistant observed the resident and noticed that the resident appeared to be blue. CMS Ex. 5, at 1. The nursing assistant also noticed that the resident's extremities were cold to the touch. Id. The nursing assistant reported her findings to a licensed practical nurse. Id.

• The licensed practical nurse observed Resident # 1 and determined that the resident was displaying signs of respiratory distress. CMS Ex. 4, at 27. The resident's fingers, nail beds, and the area around the resident's mouth appeared to be mottled. Id. The resident's blood oxygen saturation level was 78 percent. Id.

• The nurse initiated nasal oxygen in order to improve the resident's blood oxygen saturation level up to 92 - 93 percent. CMS Ex. 4, at 27. At first the nurse administered oxygen at a rate of one and one-half liters per minute. She then increased the rate of flow, first to five liters per minute and then to six liters per minute. Id.

• At 7:35 a.m. on July 21, 2002, Resident # 1's blood oxygen saturation level was observed to be at 88 and "up to" 92 percent. CMS Ex. 4, at 27. At 8:15 a.m. the resident denied being in pain and asked to sit in a chair. Id. The resident continued to be very pale in color. His respiration was recorded to be 32 inhalations per minute and his pulse was recorded at 52 beats per minute. Id.

• Petitioner's staff made no effort to contact Petitioner's physician between 7:15 and 8:15 a.m. on July 21, 2002. See CMS Ex. 4. Petitioner's physician was making rounds at Petitioner's facility on the morning of July 21, 2002 and, at about 8:15 on that morning or shortly thereafter, Petitioner's staff asked the physician to check on Resident # 1. CMS Ex. 4, at 27; CMS Ex. 5, at 10.

• The physician observed Petitioner's staff attempting to feed Resident # 1. The resident was sitting in a chair and was confused. His blood oxygen saturation level was decreased. CMS Ex. 5, at 10. The physician ordered that Resident # 1 be transported to a hospital emergency room for evaluation. Id. The physician wanted the resident to be transported quickly. Id.

The foregoing facts are drawn directly from evidence consisting of Petitioner's own records and the surveyors' interview with Resident # 1's physician. CMS Ex. 4; CMS Ex. 5. On its face, this evidence supports a finding of noncompliance by Petitioner with the requirements of 42 C.F.R. § 483.10(b)(11). It establishes that Resident # 1 experienced a significant, indeed life-threatening, change in his condition on the morning of July 21, 2002. But, in the face of that change, Petitioner's staff failed to immediately notify the resident's physician. Resident # 1, whose condition had been stable during the three days prior to July 21^st, clearly went into acute respiratory distress at about 7:15 on the morning of the 21^st. Not only did his blood oxygen saturation level drop precipitously, but the resident manifested changes in his appearance and behavior that were consistent with severe cardiopulmonary distress. However, Petitioner's staff delayed, for at least an hour, notifying the resident's physician of this change.

The significance of the change in the resident's condition on the morning of the 21^st of July is established by Petitioner's staff's response to the resident's appearance and blood oxygen saturation level. A nursing assistant recognized that the resident was in distress and contacted a nurse. A nurse saw that the resident was suffering from severe oxygen deprivation and initiated oxygen on an emergency basis. Moreover, it eventually dawned on the nurse that the changes were so significant as to necessitate physician notification because, after an hour, she brought these changes to the attention of the resident's treating physician. The physician recognized immediately that these changes were significant. Upon seeing the resident, he ordered that the resident be transferred quickly to a hospital emergency room.

The direct evidence of Petitioner's noncompliance is reinforced by the opinion of Dr. Vaitkevicius. CMS Ex. 17; CMS Ex. 18. Dr. Vaitkevicius is a board-certified internist and cardiologist and his opinion is persuasive. Ids. Dr. Vaitkevicius opined, based on the clinical evidence of the resident's appearance on the morning of July 21, 2002, and on the record of his blood oxygen saturation level, that Resident # 1 "underwent a profound deterioration" on that date. CMS Ex. 18, at 4. The clinical evidence established that the resident was undergoing a "profound and adverse cardiac event - the acute development of congestive heart failure." Id. at 5. Professionally recognized standards of care required that Petitioner's staff should have contacted the resident's physician immediately upon first observing the resident's condition on the 21^st of July because "the likelihood that an individual will survive a severe cardiac event of this degree decreases dramatically the longer that the individual's condition remains untreated." Id. Moreover, Petitioner's staff was not qualified to provide the resident with the kind of care that the resident needed and, thus, care by the staff would not be an adequate substitute for a physician's care in a hospital. Id.

Dr. Vaitkevicius' testimony is not a necessary element of CMS's case as to Petitioner's staff's failure timely to notify Resident # 1's physician, although it strongly and persuasively supports that case. CMS established a prima facie case of Petitioner's failure to make timely physician notification without Dr. Vaitkevicius' testimony. Evidence drawn from Petitioner's own records, and from the interview of Resident # 1's physician, is sufficient for me to conclude that there was a significant change in the resident's condition and a failure by Petitioner's staff to notify the resident's physician timely of that change. CMS Ex. 4; CMS Ex.5.

Petitioner makes four arguments in response to CMS's prima facie case. First, it asserts that the changes that its staff observed in Resident # 1's condition on the morning of July 21, 2002 were not really significant within the meaning of 42 C.F.R. § 483.10(b)(11). Second, Petitioner contends that it monitored and treated appropriately Resident # 1's condition on the morning of July 21, 2002, thereby making immediate physician notification unnecessary. Third, Petitioner asserts that the timing of its notification of Resident # 1's physician on the morning of the 21^st of July was reasonable because the physician could not have seen the resident any sooner had the nurse called the physician rather than awaiting his arrival. Finally, Petitioner argues that its staff acted reasonably by not notifying Resident # 1's physician immediately of the changes that were observed at 7:15 on the morning of July 21, 2002 because the resident appeared to be improving after Petitioner's staff administered oxygen to the resident. I do not find these arguments to be persuasive.

Petitioner premises its argument that there was not a significant change in the resident's condition, on the assertion that there was no significant alteration required to the care ordered for Resident # 1 in order to respond to the clinical changes that the staff observed on the morning of the 21^st. According to Petitioner, the physician's orders provided for administration of oxygen in the event of respiratory distress. Petitioner's staff simply carried out orders, according to Petitioner, and hence nothing "significant" occurred.

First, Petitioner's assertion is wrong as a matter of fact. The resident's physician's order did not suggest that Petitioner's staff could administer oxygen to the resident routinely. Administration of oxygen was ordered only in the event of a drop in the resident's blood oxygen saturation level, a significant decline in the resident's status. More important, Petitioner's analysis of the facts and law would render 42 C.F.R. § 483.10(b)(11) meaningless. The regulation clearly is intended to assure that a physician is notified of any change in a resident's condition that jeopardizes the resident's safety or life. Here, Resident # 1 was literally turning blue when he was first observed by the certified nursing assistant and by the licensed practical nurse. His blood oxygen saturation level had dropped to a point that would be lethal if unaddressed. That change is significant by any measure and it triggered the notification requirement of the regulation.

Petitioner's argument that it supplied appropriate care to the resident, by monitoring him and by giving him oxygen, simply begs the question of whether the staff fulfilled its obligation to notify the resident's physician of a significant change in Resident # 1's condition. See Petitioner's brief at 10. The appropriateness of the care that Petitioner's staff gave to Resident # 1 on the morning of July 21, 2002 - other than Petitioner's staff's failure to notify the resident's physician of the change in the resident's condition - is not at issue when considering whether Petitioner complied with the physician notification requirement of 42 C.F.R. § 483.10(b)(11). ⁽²⁾

Petitioner offered the testimony of David L. Jackson, M.D., Ph.D., to support its assertion that the care given to Resident # 1 was appropriate. P. Ex. 29. According to Dr. Jackson:

It is not at all unreasonable for staff to assess a resident and then to implement the intervention(s) already ordered by the attending physician in case the resident developed signs of respiratory distress/hypoxemia.

Id. at 2. However, this testimony does not address the central issue raised by CMS in alleging that Petitioner failed to comply with the requirements of 42 C.F.R. § 483.10(b)(11). Nowhere does Dr. Jackson opine that the changes that occurred in Resident # 1's condition on the morning of July 21, 2002 were not significant. Nor does Dr. Jackson assert that Petitioner's staff acted reasonably in failing to notify the resident's physician of these changes for an hour or more after the staff first observed them. ⁽³⁾

Petitioner offers no evidence to support its contention that Resident # 1's physician could not have come to Petitioner's facility earlier than 8:15 on the morning of July 21, 2002. Furthermore this argument, like Petitioner's previous argument, begs the question of what is at issue in terms of Petitioner's compliance with the requirements of 42 C.F.R. § 483.10(b)(11). The premise of this regulation is that there must be immediate communication with a physician in the event of a significant change in a resident's condition. Such communication can occur whether or not a physician is physically present at a facility. If Petitioner's staff had telephoned the resident's physician upon first observing the changes in Resident # 1's condition and related their findings to the physician, the physician might have been able to issue orders - including directing that the resident be sent immediately to a hospital - at least one hour sooner than he did.

Finally, I am unpersuaded by Petitioner's argument that its staff did not need to notify the resident's physician because the resident's condition improved after first being observed at 7:15 on the morning of July 21, 2002. It is not necessarily true that Resident # 1's condition improved after 7:15 on the morning of the 21^st. The resident died within hours of his transfer to a hospital. But, the staff's duty to notify the resident's physician immediately was not negated even by an appearance of improvement in the resident's condition in the hour or so following the first observation of the resident at 7:15 on the morning of the 21^st. The premise of 42 C.F.R. § 483.10(b)(11) is that a significant change in a resident's condition may trigger the need for a physician to make findings and to issue orders that only a physician is qualified to make. That is why immediate notification of the physician of a significant change is made mandatory by the regulation. The regulation makes no exception for a case where a resident appears to improve after undergoing a significant change in his or her condition.

b. Petitioner failed to comply substantially with the requirements of 42 C.F.R. § 483.25.

The Medicare participation requirement at 42 C.F.R. § 483.25 mandates that a facility provide each resident with the necessary care and services to maintain the highest practicable physical, mental and psychosocial well-being in accordance with that resident's comprehensive assessment and plan of care. The regulation does not define the term "necessary care and services." In the absence of a specific definition of the term, it is reasonable to read the regulation as embodying a requirement that, in providing services to its residents, a facility must comply with professionally recognized standards of care. Heritage Manor of Columbia, DAB CR995 (2003).

CMS alleges that Petitioner failed in four respects to comply with the requirements of the regulation. First, Petitioner's staff allegedly failed to measure or assess Resident # 1's vital signs after the resident was observed to be in distress on the morning of July 21, 2002. CMS's brief at 30. Second, the licensed practical nurse on Petitioner's staff who was summoned to assist Resident # 1 on the morning of July 21, 2002 allegedly failed to report her observations to her registered nurse supervisor as is required by Petitioner's policy and procedures and by professionally recognized standards of care. CMS's brief at 31 - 32. Third, CMS asserts that the staff's failure to notify Resident # 1's physician of the change in the resident's condition, for at least an hour after the change was first observed, was a violation of professionally-recognized standards of care. Fourth, Petitioner unreasonably delayed arrangements for the resident's transfer to a hospital.

CMS relies on the facts and evidence that I describe at Subpart a. of this Finding to support these contentions. It relies on additional contentions consisting of the following:

• There is nothing in Resident #1's clinical record to show that anyone on Petitioner's staff measured or assessed the resident's vital signs (temperature, heart rate, pulse, blood pressure, and respiratory rate) between 7:15 on the morning of July 21, 2002, when the resident was first observed to be in respiratory distress, and 9:30 on that morning, when an ambulance arrived to take the resident to the hospital. See CMS Ex. 4, at 27 - 28.

• Resident # 1's diagnoses included a recent diagnosis of diabetes mellitus for which the resident was receiving insulin. CMS Ex. 7, at 27. Petitioner's staff was instructed by the resident's physician to monitor the resident's blood sugar level. P. Ex. 8, at 1. An excessively high blood sugar level may cause an individual to experience shock. CMS Ex. 15, at 4, n. 1. However, no measurement was made by Petitioner's staff of the resident's blood sugar level after 7:15 on the morning of July 21, 2002. See CMS Ex. 4, at 27 - 28.

• Petitioner's written policy and procedures directed that, in the event of a significant change in the medical condition of a resident, a licensed practical nurse must notify his or her registered nurse supervisor or a designated registered nurse of the change. The policy and procedures provided additionally that the registered nurse would complete an assessment of the resident and assure that appropriate interventions occurred as were indicated by the resident's condition and needs. CMS Ex. 9, at 1.

• The licensed practical nurse who attended Resident # 1 on the morning of July 21, 2002 did not notify any other staff member of Petitioner's facility prior to 8:30 on that morning of the change in the resident's condition. See CMS Ex. 4, at 27.

• Although Resident # 1's physician ordered that the resident be transferred to a hospital at 8:30 on the morning of July 21, 2002, Petitioner's staff did not call for an ambulance until 9:20 on that morning. CMS Ex. 6, at 2.

• The ambulance arrived at Petitioner's facility at 9:30 on the morning of July 21, 2002. CMS Ex. 6, at 2. At that time, Resident # 1's pulse was recorded at 52 beats per minute, his blood pressure at 98/60, and his respiration at 24 per minute. On arrival at the hospital at 9:43 on the morning of the 21^st of July, the resident's temperature was recorded at 88 degrees Fahrenheit, his pulse at 27 - 29 beats per minute, his respiration at 44 per minute, and his blood pressure at 80/50. CMS Ex. 7, at 5. The resident was only minimally responsive to stimuli at the time of his arrival at the hospital. Id. at 1. He died at 7:05 on the evening of July 21, 2002.

CMS made out a prima facie case that the above-described contentions establish failures by Petitioner to comply with professionally-recognized standards of nursing care by showing how the facts and evidence demonstrate failures by Petitioner to comply with these standards. First, CMS offered proof to show that a basic principle of nursing requires that a facility's nursing staff obtain a complete record of a resident's vital signs where there is a significant change in that resident's condition. CMS Ex. 14, at 10. Indeed, this standard is consistent with Petitioner's own internal policy. CMS Ex. 9, at 1. In this case, the need to record the resident's vital signs included measuring the resident's blood sugar given the resident's recent diagnosis of diabetes. The prima facie evidence offered by CMS shows that Petitioner's staff failed to discharge these obligations to the resident in the initial hour after the resident's change in condition was first observed.

Second, CMS offered proof to establish that there is a professionally-recognized standard of care which requires that a licensed practical nurse obtain the supervision of a registered nurse before deciding what care to give to a resident that has experienced a significant change in his or her condition. Petitioner's internal policy embodies this standard and it is consistent with the requirements of North Carolina law. N.C. Gen. Stat. Ann. §§ 90-171.20(7)(a) and 90-171.20(8)(a); N.C. Admin. Code tit. 21, r. 36.0224(b); N.C. Admin. Code tit. 21, r. 36.0225(b). Under North Carolina law, a licensed practical nurse's role in interpreting physical data about a patient during an assessment of that patient is limited to assisting and participating in the analysis performed by a registered nurse. Consequently, a licensed practical nurse is obligated to inform and obtain the supervision of a registered nurse before assessing a patient and implementing care. An exception exists where there is an emergency requiring an immediate intervention. But, that does not release the licensed practical nurse from the duty of having to notify a registered nurse of an event and from ultimately being supervised by a registered nurse.

Here, the prima facie evidence is that Petitioner's staff did not comply with Petitioner's policy or with applicable law on the morning of July 21, 2002. The licensed practical nurse may have been authorized to provide oxygen to the resident immediately upon observing his condition at 7:15 on that morning. However, the nurse remained under a continuing obligation to notify her registered nurse supervisor about what was happening and to seek guidance from the supervisor. That, she failed to do.

Third, CMS showed that, as a matter of law, the professionally-recognized standard of nursing care for Medicare-participating facilities requires immediate notification of a resident's physician by a facility's staff of a significant change in the resident's condition. 42 C.F.R. § 483.10(b)(11). As I discuss in Subpart a. of this Finding, Petitioner's staff failed to comply with the standard.

Fourth, CMS offered proof to show that professionally-recognized standards of nursing care require that facility staff exercise reasonable judgment in deciding how to transport an acutely ill resident to a hospital after being ordered to do so. See CMS Ex. 14, at 13 - 14. The prima facie evidence offered by CMS is that, as a matter of common sense and based on the observed changes in Resident # 1's condition on the morning of July 21, 2002, Petitioner's staff should have interpreted the physician's order that Resident # 1 be transferred to a hospital as an order that the transfer be done immediately. Id. Yet, the prima facie evidence is that Petitioner failed to comply with this standard. It was about an hour from the time that the physician first saw Resident # 1 until Petitioner's staff telephoned for an ambulance.

The evidence and arguments that Petitioner offered to rebut CMS's prima facie case are not persuasive. First, Petitioner asserts that the licensed practical nurse who attended to Resident # 1 "immediately took the resident's vital signs . . ." after first observing the resident at 7:15 on the morning of July 21, 2002. Petitioner's brief at 9. As support for this contention, Petitioner relies on the declaration of the licensed practical nurse, who attended Resident # 1. She avers that, shortly after 8:15 on the morning of July 21, 2002 she discussed Resident # 1's medical condition with the resident's physician and, at that time, gave the physician the resident's vital signs "that consisted of blood pressure (90/70) respiration (32) and apical pulse (52)." P. Ex. 15, at 2. This declaration responds in part - but only in part - to CMS's contention that Petitioner's staff failed to measure the resident's vital signs after 7:15 on the morning of the 21^st of July. Neither Petitioner nor the nurse avers that the resident's blood sugar was checked. As I discuss above, checking the resident's blood sugar was a necessary element of measuring the resident's vital signs given the resident's recent diagnosis of diabetes mellitus and, hence, the possibility that the resident might be in diabetic shock. Petitioner has not overcome CMS's prima facie evidence that its staff failed to discharge this responsibility to the resident.

Petitioner characterizes the unrebutted allegations that its staff failed to check Resident # 1's blood sugar as a "red herring intended to divert this tribunal's attention away from the pertinent issues." Petitioner's response brief at 10. I do not agree with Petitioner that the failure by Petitioner's staff to check the resident's blood sugar is a "red herring." This resident had recently been diagnosed with diabetes. It was incumbent on Petitioner's staff, once they discovered Resident # 1 in obvious respiratory distress on the morning of July 21, 2002, to thoroughly and completely assess the resident. Such an assessment included checking the resident's blood sugar in order to determine whether his blood sugar level might be causing the change in the resident's condition. By failing to do that, the staff was unable to give the resident's physician a complete picture of the resident's condition.

Second, Petitioner responds to CMS's contention that its staff failed to notify the registered nurse supervisor about the changes in Resident # 1's condition by arguing that the licensed practical nurse who attended to Resident # 1 was constantly monitoring and checking on the resident's condition. Moreover, according to Petitioner, this nurse has nearly 50 years' experience as a licensed practical nurse, and nearly 20 years' experience with Petitioner. Petitioner asserts that, while technically the nurse should have notified her supervisor about the change in Resident # 1's condition (assuming that a significant change occurred), no potential for even minimal harm existed in this case due to the licensed practical nurse's experience, and because of the timely and thorough assessment of the resident's physician.

I do not find this argument to be persuasive. The premise which underlies the standard of care, and in North Carolina the legal requirement, requiring a licensed practical nurse to notify a supervising registered nurse of a change in a resident's condition and to work thereafter under the supervision of the registered nurse, is that a licensed practical nurse does not have the training necessary to make the kinds of decisions that are made by a registered nurse. This premise is reflected in Petitioner's own policies. Besides, one can hardly say that there was no harm here. As I discuss below, at Finding 2, the failure by the licensed practical nurse to timely notify Resident # 1's physician of the change in the resident's condition potentially jeopardized the resident's life. It is reasonable to infer that, had the licensed practical nurse notified her supervisor timely, the supervisor might have comprehended the need to notify the physician immediately.

Third, Petitioner re-avers the arguments concerning its staff's failure to timely notify Resident # 1's physician about the change in the resident's condition that was made at Subpart a. of this Finding. I find these arguments not to be persuasive here for the same reasons that I find them not to be persuasive at Subpart a.

Finally, Petitioner asserts that its staff did not delay in calling for an ambulance to transport Resident # 1 to a hospital. Petitioner asserts that it took no longer than 30 minutes to effectuate the transfer of the resident. See Petitioner's brief at 9, n.9. In fact, the evidence supports the conclusion that the minimum delay between the time of the physician's order for transport and the call by Petitioner's staff to the ambulance service was 30 minutes. That is the timeline based on Petitioner's reconstruction of the events of the morning of July 21, 2002. See Id. Other evidence, as cited by CMS, suggests a longer delay between the moment the physician issued the order to transport the resident and the moment when Petitioner's staff called the ambulance service. If the physician saw the resident at about 8:30 a.m. on the 21^st, as is suggested by nursing notes, and the call to the ambulance company was made at about 9:20 on the morning of that date, as is suggested by the surveyors' interview with the ambulance service, the delay in calling the service would be more like 50 minutes rather than the 30 minutes that Petitioner avers. See CMS Ex. 4, at 27 - 28; CMS Ex. 5, at 6.

However, even a 30-minute delay was unreasonable. By approximately 9:20, when Petitioner's staff made its call to the service, more than two hours had elapsed from the time that the resident was first observed to be in respiratory distress. It should have been clear to Petitioner's staff that a delay in transporting the resident was potentially dangerous to the resident's health. Indeed, Petitioner has offered no explanation whatsoever for its staff's failure to respond immediately to the physician's order to transport the resident to the hospital.

Petitioner now appears to argue that, if the resident was in cardiogenic shock while at Petitioner's facility on the morning of July 21, 2002, no benefit would have accrued to the resident from an immediate transfer to a hospital. See Petitioner's response brief at 11. "If such was the case, which cannot be determined, his condition could neither be maintained nor improved." Id. From this, Petitioner seems to suggest that any delay in transporting the resident to a hospital is irrelevant because the delay did not decrease the resident's already very poor chances of survival.

It may be that the resident would have expired no matter what efforts Petitioner's staff made on his behalf. But, the fact that the resident likely would have died anyway is not a justification for the failure of Petitioner's staff to discharge its duty to the resident. The staff had no way of knowing for sure what was likely to happen to the resident on the morning of July 21, 2002. Its obligation was not to act based on its assessment of the resident's survival chances, but to promptly and faithfully execute the orders of the resident's physician. In this respect the staff was derelict.

Finally, Petitioner asserts that it is unfair to put it in the position of having to defend against the allegation that it delayed unreasonably in calling for an ambulance to transport Resident # 1 to a hospital inasmuch as this allegation was not made specifically in the report of the August 2002 survey. See CMS Ex. 3. However, CMS did make the allegation well in advance of the scheduled hearing in this case, thereby giving Petitioner ample notice and opportunity to respond. For example, CMS explicitly raised the allegation in its amended prehearing brief which it filed on October 10, 2003. CMS's amended prehearing brief at 20. For that reason I find no denial of due process to Petitioner.

2. Petitioner did not prove that CMS's determination that Petitioner's noncompliance was at the immediate jeopardy level to be clearly erroneous .

An immediate jeopardy level deficiency 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 cause, serious injury, harm, impairment, or death to a resident.

A finding by CMS of the presence of immediate jeopardy must be affirmed, unless it is clearly erroneous, if the underlying deficiency on which the immediate jeopardy finding is based is substantiated. 42 C.F.R. § 498.60(c)(2). This standard of proof places a heavy burden on a provider who challenges a finding of immediate jeopardy:

[U]nder the clearly erroneous standard, we cannot meddle with a prior decision . . . simply because we have doubts about its wisdom or think we would have reached a different result. To be clearly erroneous, a decision must strike us as more than just maybe or probably wrong; it must . . . strike us as wrong with the force of a five-week-old unrefrigerated dead fish.

Parts and Elec. Motors, Inc. v. Sterling Elec., Inc., 866 F.2d 228, 233 (7^th Cir. 1988). A determination must be found not to be clearly erroneous where there is substantial evidence to support that determination. Snow v. Standard Ins. Co., 87 F.3d 327, 331 - 332 (9^th Cir. 1996).

CMS's determination that Petitioner's deficiencies posed immediate jeopardy for residents - particularly that the failure to notify Resident # 1's treating physician timely posed immediate jeopardy - is supported by more than substantial evidence. CMS offered credible evidence to establish that Petitioner's failure to execute its obligations to Resident # 1 created a likelihood that the resident would sustain serious harm or death.

The evidence offered by CMS shows that Petitioner jeopardized the resident's health and life by failing to react immediately to what its staff observed on the morning of July 21, 2002. There was a palpable lack of urgency displayed by Petitioner's staff. The staff was lackadaisical in evaluating and assessing the resident, in notifying the resident's physician about the resident's condition, and in executing the physician's order that the resident be transferred. The consequence was Petitioner delayed transferring Resident # 1 to a hospital - the only act that might have saved the resident's life - inexcusably. Finding 1; CMS Ex. 18, at 5, 12.

Petitioner's failure to notify Resident # 1's physician immediately upon its staff's observing the change in the resident's condition and to arrange transport of Resident # 1 to a hospital immediately upon being ordered to do so by the resident's physician, placed the resident at grave risk for permanent impairment or death. Resident # 1 almost certainly was experiencing cardiogenic shock by the time the ambulance personnel arrived at Petitioner's facility. CMS Ex. 18, at 12. Cardiogenic shock has a dismal survival rate even in the best of circumstances. Id. However, had Petitioner's staff reacted immediately to the changes observed in Resident # 1 on the morning of July 21, 2002, the resident's chances for survival would have improved significantly.

The evidence that I have just discussed is persuasive proof of immediate jeopardy level deficiencies. Evidence and arguments offered in response by Petitioner did not overcome CMS's case, much less did it show CMS's determination of immediate jeopardy level deficiencies to be clearly erroneous.

Petitioner contends that its staff followed proper nursing practice by trying to stabilize Resident # 1's condition prior to contacting the resident's treating physician. P. Ex. 29. I have addressed this argument previously at Finding 1 and I find it to be without merit here. Neither applicable law nor nursing standards of care justified even a minute's delay in contacting the resident's treating physician after the resident's respiratory distress was first observed on the morning of July 21, 2002. The resident clearly was in a dire, life-threatening state. Petitioner's staff should have known that it was absolutely necessary to obtain a physician's assessment and orders. Anything less than that was a dereliction of its duty to the resident.

Petitioner also asserts that Resident # 1 did not enter into a state of cardiogenic shock until well after he arrived at the hospital. For support, Petitioner relies on the resident's death certificate which, according to Petitioner, fixes the onset of cardiogenic shock as one hour prior to the resident's death at 7:05 p.m. on July 21, 2002. I find this document to be an unpersuasive description of what happened to Resident # 1. The credible evidence, which I have discussed, was that the resident was in an advanced state of cardiac and respiratory distress even before he was transported to the hospital. But, in fact, the precise moment that the resident entered into cardiogenic shock is irrelevant. Much more significant is the fact that the resident clearly was deteriorating, dramatically and suddenly, while at Petitioner's facility and Petitioner's staff delayed taking actions that were necessary to protect the resident.

Finally, Petitioner contends that the resident actually improved during the period between the time when his condition was first observed on the morning of July 21, 2002, and the time when he was transported to the hospital. Petitioner argues that it can hardly be held to have jeopardized the resident's health or life if, in fact, the resident improved while he was under its care. I am not persuaded by this argument. The resident's "improvement" was only symptomatic and not real. Petitioner's staff should have realized that the appearance of improvement was not a basis to delay contacting the resident's physician, or for failing to take other actions that were mandated by the resident's condition.

The credible testimony of Dr. Vaitkevicius is that signs of improvement in the resident's blood oxygen saturation level, or in his skin color, did not mean that the resident's underlying condition - sudden congestive heart failure - was improving. CMS Ex. 18, at 9. Moreover, there were other signs or symptoms displayed by the resident, including nausea and vomiting, that would have led a trained physician to realize that a serious cardiac event was ongoing. Id. Indeed, when the resident's physician finally saw Resident # 1, he recognized immediately that the resident was not improving and ordered the resident be transported to a hospital.

3. Petitioner's noncompliance continued until August 13, 2002.

A substantiated finding, that a facility is not complying with participation requirements in one or more respect, imposes on that facility the burden of showing how and when it corrected that noncompliance. It is not CMS's burden to justify its finding that a facility returned to compliance as of a particular date. Rather, the obligation lies squarely on the facility to prove that it has attained compliance with participation requirements.

Here, CMS determined that Petitioner did not attain compliance until August 13, 2002. That determination logically was based on the surveyors' findings that Petitioner did not take corrective actions to address its deficiencies - consisting of in-service training of its staff regarding emergency transfer protocol, acute episodes, and emergency care and notification - until August 13 and 14, 2002. CMS Ex. 3, at 13.

Petitioner argues that, if it was noncompliant at all on July 21, 2002, that noncompliance was an isolated event which did not continue past the 21^st of July. Essentially, Petitioner argues that the events at issue in this case are "isolated" because they comprise the only circumstance relied on by CMS to show failure by Petitioner's staff to take appropriate action to deal with acute changes in a resident's condition. Petitioner argues that its staff in fact responded properly in other analogous circumstances, thereby demonstrating that the events of the 21^st were indeed anomalous and isolated. As support for this assertion, Petitioner relies on excerpts from its treatment records of other residents and Ms. Ard's declaration. P. Exs. 21 - 26; P. Ex. 30.

I am not persuaded by these arguments, or by the supporting evidence offered by Petitioner, that the episode of July 21, 2002 was unlikely to recur. The events involving Resident # 1 may have been the only ones of their type to occur between July 21 and August 13, 2002, but these events clearly justify finding the presence of systemic problems at Petitioner's facility that were uncorrected prior to August 13^th. The compounding of judgment errors by Petitioner's staff in the case of Resident # 1 support a conclusion that the staff member or members had a fundamental misunderstanding of the obligations and responsibilities to provide care. There was an array of failures which support this conclusion: failure to understand the significance of the clinical signs and symptoms displayed by Resident # 1; failure to comprehend the urgent need to notify a physician immediately about these signs and symptoms; failure to recognize the need to make detailed findings and assessments about the resident's condition; failure to understand the duty to involve better qualified facility personnel in the care of Resident # 1; and, failure to assure that the resident was transported immediately to a facility that was better equipped than was Petitioner to deal with the resident's medical crisis.

Even if the basic misunderstanding of responsibilities and duties was confined to a single member of Petitioner's staff, the licensed practical nurse who was responsible for Resident # 1's care on July 21, 2002, this nurse remained an employee of Petitioner through August 13, 2002. During the period between July 21, 2002 and August 13, 2002, this staff member's misunderstanding of her duties was not corrected by Petitioner and, thus, other residents were potentially at risk.

Petitioner's evidence does not overcome proof that there was an ongoing and systemic problem at Petitioner's facility during the July 21 - August 13, 2002-period. Ms. Ard attests that she reviewed 13 resident transfers from Petitioner's facility to hospitals during this period and she concluded from these reviews that the staff acted appropriately in each case. P. Ex. 30. However, she provides no details as to the specific facts of these transfers and her general assertions are not persuasive. Id. Moreover, even if Petitioner's staff acted appropriately in each of these cases, that does not prove that the staff - and in particular, the licensed practical nurse who was involved with Resident # 1 - would have reacted correctly in every case. Indeed, the case of Resident # 1 is proof that Petitioner's system for dealing with cases of acute changes in residents' conditions was not "being utilized appropriately and functioning properly," Ms. Ard's assertion to the contrary notwithstanding.

The evidence offered by Petitioner is not persuasive because it does not establish any recognition by Petitioner or its staff that the failure to respond appropriately in the case of Resident # 1 constituted an egregious violation of professionally-recognized standards of care and Petitioner's own policies. The episode obviously went unnoticed and was not identified by Petitioner as constituting a warning signal of an internal problem until brought forcefully to Petitioner's attention by the surveyors who conducted the August 2002 survey. The fact that Petitioner failed to recognize so obvious a dereliction of duty is sufficient proof of an ongoing potential for serious problems which, until detected and addressed via corrective action, is not overcome by subsequent examples of correct action by Petitioner's staff.

Nor is it reasonable to assert that the deficiencies at Petitioner's facility ended with the transfer of Resident # 1 to the hospital. The deficiencies are evidenced by the care that its staff gave to Resident # 1. But, the deficiencies are not the care that was given to the resident so much as the lack of comprehension of duties manifested by one or more members of Petitioner's staff. Those deficiencies persisted until the staff was educated about its duties and responsibilities.

4. Civil money penalties of $5,000 per day are reasonable.

The range of civil money penalty amounts that may be imposed to remedy immediate jeopardy level deficiencies is from $3,050 to $10,000 per day. 42 C.F.R. § 488.438(a)(1)(i). The penalties of $5,000 per day, which CMS determined to impose against Petitioner for each day of the July 21 - August 13, 2002 period, fall within the permissible range because they address immediate jeopardy level deficiencies.

However, there remains the question of whether the penalty amounts that CMS determined to impose are reasonable penalty amounts within the permissible range. Civil money penalty amounts must be determined based on factors set forth at 42 C.F.R. §§ 488.438(f)(1) - (4) and 488.404 (incorporated by reference into 42 C.F.R. § 488.438(f)(3)). These factors include: the seriousness of deficiencies; their relationship to each other; a facility's compliance history; its culpability; and its financial condition. Ids.

CMS does not argue that Petitioner's compliance history justifies imposition of the penalties that are at issue here. Petitioner does not assert that its financial condition precludes it from paying the penalties that CMS determined to impose. That leaves open the question of whether the penalty amount of $5,000 per day is justified by the seriousness of the deficiencies and/or by Petitioner's culpability for them.

The failure of Petitioner's staff to comprehend its duties to Resident # 1 was extremely serious in light of the ailments manifested by the resident. The staff's deficient care jeopardized the resident's health and may have cost him his life. Penalties of $5,000 per day in this case are reasonable in light of the jeopardy that any misunderstanding of responsibilities, by Petitioner's staff, posed for the resident. I note that the penalty amounts that are at issue here are somewhat higher than the minimum permissible immediate jeopardy level deficiency penalty amount. But, they are however one-half of the maximum permissible daily penalty amount for immediate jeopardy level deficiencies.

Moreover, the penalty amounts appropriately affect the level of culpability manifested by Petitioner and its staff in this case. The staff was not indifferent to Resident # 1's needs. But, it was egregiously negligent and that negligence may have caused the resident his life.

Steven T. Kessel

Administrative Law Judge

1. This citation in my ruling is incomplete. I meant to refer to 42 C.F.R. §§ 498.30 and 498.32 as authorities for CMS to issue a revised determination.

2. The quality of care that Petitioner gave to Resident # 1 on the morning of July 21, 2002 is an issue under the second noncompliance allegation that CMS makes in this case. I discuss that issue below, at Subpart b. of this Finding.

3. Dr. Jackson opines also that "one could allege that there was a modest, brief delay in physician notification." P. Ex. 29, at 3. He does not contend that even a modest or brief delay was warranted in this case. At Finding 2, I explain why I find that the delay was neither modest nor brief but was, in fact, egregious.