SUBJECT:

Emerald Oaks,

Petitioner,

Centers for Medicare & Medicaid Services

DECISION

Emerald Oaks, Petitioner, requested a hearing to challenge the determination by the Centers for Medicare & Medicaid Services (CMS) to impose a per-instance civil money penalty (CMP) of $10,000 based on a deficiency cited at a survey in May 2000. Petitioner is also challenging its termination from the Medicare program on the basis of allegedly six months of regulatory noncompliance. The above two remedies were imposed by CMS.

For the reasons set forth below in my findings and conclusions, I decide that CMS had the authority to impose the per-instance CMP because Petitioner was not in substantial compliance with the cited participation requirements for nursing facilities. I also conclude that the noncompliance created a situation of immediate jeopardy and that the per-instance CMP of $10,000 is reasonable. Accordingly, CMS was authorized to terminate Petitioner's Medicare participation agreement.

I. Background

The provider is a 120-bed nursing facility located in Sarasota, Florida. CMS found that the provider was not in substantial compliance with Medicare participation requirements based on the May 3, 2000 survey by the Florida Agency for Health Care Administration (State survey agency).⁽¹⁾ The State survey agency conducted four surveys at Petitioner's nursing facility, which concluded on the following dates: May 3 (May survey), June 15 (June survey), August 31 (August survey), and October 26, 2000 (October survey). Petitioner filed a timely hearing request to appeal the imposition of certain remedies imposed by CMS based on deficiencies cited by the State survey agency. The contested remedies include a $10,000 per-instance CMP, based on a jeopardy-level deficiency identified during the survey of May 3, 2000; denial of payment for new admissions effective August 29, 2000; and a proposal to terminate Petitioner's participation in Medicare and Medicaid if Petitioner did not resume substantial compliance with applicable regulatory requirements by October 30, 2000. The appeal was docketed by this office on October 23, 2000. On October 26, 2000, the State survey agency conducted a revisit survey in which it found two deficiencies. Based on these two deficiencies, CMS determined that Petitioner did not resume substantial compliance by October 30, 2000.

On November 6, 2000, CMS notified Petitioner that the proposed termination became effective on October 30, 2000. On November 10, 2000, Petitioner filed a motion to amend its hearing request to add the October 26, 2000 findings to the pending appeal. Petitioner also requested an expedited hearing, limited to addressing the two deficiencies found pursuant to the October 26, 2000 survey. Petitioner reasoned that if those deficiencies are set aside, CMS's termination action would be rescinded.

On November 20, 2000, CMS filed a response in which it did not oppose Petitioner's motion to amend its hearing request and it did not oppose Petitioner's request for an expedited hearing. CMS did oppose Petitioner's motion to address only the deficiencies found at the October 26, 2000 survey at the expedited hearing.

Judge Kessel was initially assigned this case and he convened a prehearing conference on November 21, 2000. During the conference, the parties agreed to consolidate into this case issues that pertain to the October 26, 2000 survey and to go forward with an expedited in-person hearing. They agreed that the scope of the hearing would be whether CMS had a basis for imposing the $10,000 per-instance CMP and whether a basis exists to terminate Petitioner's participation in Medicare.

On December 19, 2000, due to exigent weather conditions, Judge Kessel was unable to travel to the hearing location. Since I attended the hearing, the parties agreed that I should hear and decide the case. An expedited in-person hearing was conducted in Tampa, Florida, on December 19 to 20, 2000. During the hearing, each party called witnesses to testify. The transcript of the hearing is referred to as (Tr.). The provider offered Petitioner's exhibits (P. Exs.) 1 - 90, which were admitted into evidence. CMS offered exhibits (CMS Exs.) 1 - 27, which were admitted into evidence. The parties submitted simultaneous posthearing briefs (P. Br. and CMS Br.) and reply briefs (P. R. Br. and CMS R. Br.).

II. Applicable law

Long-term care providers, such as the provider herein, participate in the Medicare program by entering into provider agreements with the United States Department of Health and Human Services. Requirements of participation are imposed by statute and regulation. Social Security Act (Act), section 1819 [42 U.S.C. § 1395i-3]; 42 C.F.R. Parts 483, 488, and 489.

The regulations define "substantial compliance" as follows: "Substantial compliance means a level of compliance with the requirements of participation such that any identified deficiencies pose no greater risk to resident health or safety than the potential for causing minimal harm." 42 C.F.R. § 488.301. The regulations define "immediate jeopardy" as follows: "Immediate jeopardy means 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.

The regulations specify that a CMP that is imposed against a provider will fall into one of two broad ranges of penalties. 42 C.F.R. §§ 488.408, 488.438. The lower range of CMPs, from $50 per day to $3,000 per day, is reserved for deficiencies that do not constitute immediate jeopardy, but either cause actual harm to residents, or cause no actual harm, but have the potential for causing more than minimal harm. 42 C.F.R. § 488.438(a)(2). The upper range of CMPs, from $3,050 per day to $10,000 per day, is reserved for deficiencies that constitute immediate jeopardy to a provider's residents, and, in some circumstances, for repeated deficiencies. 42 C.F.R. §§ 488.438(a)(1), (d)(2). When penalties are imposed for an instance of noncompliance, the penalties will be in the range of $1,000 to $10,000 per instance. 42 C.F.R. § 488.438(a)(2).

The preponderance of the evidence standard is applied to resolve disputed issues of fact, except as provided by 42 C.F.R. § 498.60(c)(2), which states that in CMP cases, CMS's determination as to the level of noncompliance of a provider must be upheld unless it is clearly erroneous. CMS bears the burden of coming forward with evidence sufficient to establish a prima facie case that the provider was not in substantial compliance with the participation requirements at issue. Once CMS has established a prima facie case, the provider has the ultimate burden of persuasion: to prevail, the provider must prove by a preponderance of the evidence that it was in substantial compliance with each participation requirement at issue. See Hillman Rehabilitation Center, DAB No. 1611 (1997), aff'd, Hillman Rehabilitation Center v. U. S. Dep't of Health and Human Services, No. 98-3789, at 21 - 38 (D.N.J. May 13, 1999).

III. Stipulations

During the hearing, the parties stipulated as follows:

(1) Petitioner challenges the CMP by only contesting the finding of noncompliance cited at F Tag 224 during the survey conducted on May 3, 2000; and,

(2) Petitioner challenges its termination from the Medicare program by contesting only the survey tags cited as deficiencies during the survey conducted on October 25 - 26, 2000.

Tr. 23; CMS Br. at 1, 4; CMS Exs. 9, 21; P. Br. 1.

IV. Ruling on Petitioner's motion for summary disposition

At the end of CMS's case in chief at the hearing, Petitioner moved for summary disposition with respect to several of the deficiencies on the grounds that CMS did not make out a prima facie case according to Departmental Appeals Board precedents. Tr. 418 - 439; P. Br. 32 - 34. Petitioner argues that since no CMS witness testified, there is no evidence in the record that supports a finding that the required regulatory elements were considered before imposing a CMP. Tr. 420. CMS reserved its response to Petitioner's motion to its posthearing brief. Tr. 439; CMS Br. 14-16. CMS argued that there were no valid factual or legal grounds for Petitioner's arguments. Tr. 14. CMS takes issue with Petitioner's suggestion that CMS acted unilaterally and improperly when revisions were made to Petitioner's survey report and CMP. Tr. 15. According to CMS, documentary evidence in this case proves that the State agency and CMS concurred and, in accordance with the regulations, sent separate notices to Petitioner, including a revised survey report, determination of immediate jeopardy and a per-instance CMP, in the amount of $10,000. Tr. 15 (citing CMS Exs. 2, 8, 9). To the extent Petitioner questions the propriety of the regulations, I lack authority to consider the merits of those arguments. Such a determination would require that I decide either the lawfulness of the regulations or procedures that CMS has adopted pursuant to those regulations. The authority to decide the lawfulness of regulations or procedures has not been delegated to me. See Life Care Center of Hendersonville, DAB CR542 at 10 (1998). I do have the authority, however, to interpret regulations and procedures and to decide whether CMS has acted properly pursuant to those regulations and procedures. Nonetheless, I am required to assume that regulations and procedures that the Secretary issues are legal. CarePlex of Silver Spring, DAB CR457 at 12 (1997), aff'd in part, rev'd in part, DAB No. 1627 (1997). I do not have the authority to declare that the procedures or regulations themselves are illegal. Further, I reject Petitioner's claims that CMS's failure to present witnesses regarding the factors it considered in determining the CMP negates presentation of a prima facie case. See detailed discussion in Finding 3, page 11, below. In sum, I deny Petitioner's motion for summary judgment and proceed to the merits of the case.

V. Issues, findings of fact and conclusions of law

A. Issues

The issues in this case are:

• whether the provider was in substantial compliance with the health and safety requirements for nursing facilities, based on the surveys of May 3 and October 26, 2000;



• whether the provider was in substantial compliance with 42 C.F.R. § 483.13(c), resident behavior and facility practices. If not, a further issue is whether the non-compliance resulted in immediate jeopardy;

• whether the $10,000 per-instance CMP imposed against the provider is reasonable under the circumstances.

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 in bold face as a separate heading. I discuss each Finding in detail.

Finding 1. Petitioner was not in substantial compliance with the participation requirement at 42 C.F.R. § 483.13(c)(1)(i) during the May 2000 survey, with respect to CMS's finding of a deficiency at Tag 224, as it relates to Resident 2 . The deficiency constituted neglect resulting in a death due to inadequate supervision, which is sufficient to establish immediate jeopardy.

Finding 2. CMS's determination of the level of non-compliance was not clearly erroneous.

This is the immediate jeopardy level deficiency that was cited in the SOD (State of Deficiencies) of the May 3, 2000 survey. The SOD alleges that Petitioner failed to comply substantially with the requirements of 42 C.F.R. § 483.13(c)(1)(i). CMS Ex. 2 at 1. The regulation states as follows:

(c) Staff treatment of residents. The facility must develop and implement written policies and procedures that prohibit mistreatment, neglect, and abuse of residents and misappropriation of resident property.

(1) The facility must -

(i) Not use verbal, mental, sexual, or physical abuse, corporal punishment, or involuntary seclusion; . . .

The SOD asserts that Petitioner failed to comply with the requirements of the regulation because Petitioner allegedly failed to ensure that a resident was not neglected. The report states that "[n]ursing staff neglected the resident resulting in intubation and death." CMS Ex. 2 at 1. The report cites examples of alleged neglect of Resident 2 by Petitioner's staff as evidence to support the conclusion that Petitioner failed to comply with the regulation. It is unclear why the survey report cites subpart (i) of the regulation. The report makes no allegations that Petitioner abused, punched, or secluded this particular resident.

Resident 2 was admitted on April 22, 2000. CMS Ex. 2 at 1. Resident 2 was an 82-year-old male and his diagnosis included diabetes mellitus, chronic airway obstruction, chronic ischemic heart disease, coronary atherosclerosis, functional digestive disorder, hypertensive heart disease, cardiac dysrhythmias, gastritis, duodenitis, and coagulation defects. Id.; P. Br. at 2.

The SOD cites the following as examples of alleged failure by Petitioner to implement its policy that prohibits neglect of residents by not providing immediate and continuous assistance to one of five residents who was in acute respiratory distress. The findings include:

•admission nurses notes on 4/22/00 at 11:15 a.m. document that Resident 2 had a loose nonproductive cough and that his "lower extremities were cyanotic tend to touch." CMS Ex. 2 at 1, 2.

• nurses notes dated 4/23/00 at 3:00 p.m. document that "the resident was lethargic. A nebulizer treatment for congestion. Oxygen was administered at 2 liters. The resident had a loose-productive cough." Id. at 2.

• nurses notes on 4/24/00 at 11:30 a.m. document that Resident 2 was "lethargic this AM, Oxygen saturation 94. Scattered bronchi." Id. The physician was contacted regarding the lethargy. The physician stated "[w]e may send patient to hospital if necessary before he visits patient here." Id.

• nurses notes dated 4/24/00 at 1:00 p.m., documents Resident 2's wife at his bedside and wanting to talk to the doctor regarding sending Resident 2 to the hospital. Id.

• nurses notes on 4/24/00 at 11:48 p.m. document that the "patient is drowsy and doesn't respond to verbal stimuli." Id. Document indicates that Resident 2 has "[s]weats. No temperature." Id.

• nurses notes on 4/25/00 at 2:00 p.m. document "[p]atient very lethargic at AM, med pass this shift. Denied any pain or discomfort. PRN (as needed) nebulizer treatment given PRN orders for slight shortness of breath. Accu check at 11:30 AM, 164. Indwelling catheter patent and draining dark amber urine. Alter with confusion." Id.

• vital sign sheets did not reveal any vitals recorded on 4/25/00. Id.

• during a telephone interview with the registered nurse on 5/3/00 at 1:30 p.m., she stated that at about 2:00 p.m., the resident's wife came to the nurses station and told the nurse that the resident "[w]as having trouble breathing." Id. at 2, 3. The nurse did not go to the resident's bedside immediately. The nurse suctioned a tracheotomy resident first for about 15-20 minutes; however, that patient's clinical record did not show that suctioning or care was provided to that patient at 2:00 p.m. The nurse indicated that she went to Resident 2's room 15 - 20 minutes later; she put her head into the door. The nurse did not go to Resident 2's bedside; she did not complete vital signs; she did not do a nursing assessment. The nurse indicated that she did not call for assistance because "[t]hey are all in the same boat. You have 25 residents to care for and so many things to do." Id. at 3.

• about 3:00 p.m. on 4/25/00, the above-mentioned nurse and the oncoming nurse entered Resident 2's room and found him with significant compromised breathing problems. Id.

• Emergency Medical Service (EMS) received a call from Petitioner on 4/25/00 at 3:24 p.m. Id.

• EMS indicated that when EMS went to Resident 2's room, no staff were with him. EMS indicated that the resident has to be intubated at Petitioner's facility, so he would survive the trip to the hospital. Resident 2 expired 15 - 20 minutes later in the hospital emergency room. Id.

There is no doubt that Resident 2 was a very sick man who was suffering from serious medical conditions. P. Exs. 84, 85; P. Br. at 29. Resident 2's breathing became compromised on April 25, 2000. Id. at 1 - 3; P. Br. at 30. Petitioner argues that the allegations of deficiency do not actually state a finding that Petitioner was not complying with 42 C.F.R. § 483.13(c)(1)(i). According to Petitioner, CMS produced no evidence that Petitioner committed any act or omission that violates any regulation or standard of care with regard to Resident 2. P. Br. at 30 - 31. Moreover, Petitioner believes that Resident 2 did not suffer any injury as a result of one of Petitioner's nurse's actions. Id. at 31. Petitioner argues that CMS's isolated examples of neglect with regard to Resident 2 do not address the issue of whether Petitioner developed and implemented policies and procedures to prevent neglect. While I agree with Petitioner's analysis of the regulation in that the regulation focuses on a facility's development and implementation of an anti-neglect policy, I conclude, however, that it is not unreasonable to infer a failure by a facility to implement its policy if sufficient examples of neglect at a facility establish a systemic failure by the facility to do so. Thus, I conclude that the allegation of noncompliance under Tag 224 is not defective on its face.

According to the evidence of record, Sarah Parker, a nurse, was providing care to Resident 2 on April 25, 2000. Tr. 48, 86. Resident 2's wife approached Nurse Parker at the nurses station about 2 p.m. requesting help because the resident was having trouble breathing. Tr. 48. After 15 to 20 minutes had passed, Nurse Parker "peeked" at Resident 2 from the doorway of his room; Nurse Parker did not go to the resident's bedside, perform a nursing assessment, or evaluate or record any of his vital signs. Tr. 49, 54.

Nurse Parker's rationale for her behavior was that she "was busy with other things to do" and she stated that she did not seek help from her coworkers because "they were all in the same boat," with many things to do for the 25 residents in their care. Tr. 54. Between 2:30 p.m. and 3:24 p.m., Nurse Parker and Nurse Donna Trask entered Resident 2's room and determined that he was having serious breathing problems. Tr. 81, 82; CMS Ex. 4 at 8, 9. Petitioner's staff called the Sarasota County Fire Department (SCFD) at 3:24 p.m., seeking assistance for Resident 2. Tr. 277. At 3:29 p.m., a SCFD emergency crew arrived at Resident 2's room. Tr. 277.

Mary Boutiellier, the SCFD crew's paramedic, was a most credible witness. Tr. 274 - 289. She has over 10 years of experience as a SCFD paramedic. Id. Ms. Boutiellier arrived at Resident 2's room and observed him to be in critical respiratory distress. Tr. 277. Ms. Boutiellier also observed that none of Petitioner's staff was present in Resident 2's room; Resident 2's wife was there crying, "nearly hysterical" and frantically seeking help for her husband. Tr. 277. The wife told Ms. Boutiellier that she had tried for hours to get Petitioner's staff to treat Resident 2's breathing problems. Tr. 277.

In treating the resident, Ms. Boutiellier noted that the resident was critical; he was unresponsive; his temperature was 105 degrees Fahrenheit; he was breathing at a rate that was too fast to count (he was breathing at a rate of at least 50 breaths per minute); Tr. 285; he had no detectable blood pressure; and he was suffering from a serious lack of oxygen; Ms. Boutiellier administered high-flow oxygen . Tr. 278, 279, 281, 283.

Moreover, Ms. Boutiellier had to send a member of her SCFD crew to find a member of Petitioner's staff, to find out specifically why Petitioner called SCFD for assistance and for the staff to tell SCFD about Resident 2's condition. Tr. at 280. A CNA (certified nursing assistant) came into the resident's room, but said she knew nothing about his condition. Tr. 10 - 16. Ms. Boutiellier yelled at the CNA and told her to find someone else to provide information about the resident. Another nurse appeared and provided "very inadequate" information. Tr. 280, 281. Resident 2's wife begged Ms. Boutiellier to "do whatever she could" to help the resident, so Ms. Boutiellier intubated the resident. Tr. 284, 285, 288. A tube was inserted down the resident's throat so he could breathe sufficiently to be transported to an emergency room. Tr. 284, 285, 288. Ms. Boutiellier's crew transported Resident 2 with their emergency lights and sirens blaring. Tr. 284. Resident 2 died within 15 - 20 minutes of arriving at the emergency room. Tr. 285.

Petitioner was cited for a jeopardy-level deficiency at Tag 224 based on its failure to provide prompt and continuous care for Resident 2's acute respiratory distress. CMS Ex. 2 at 1- 3; CMS Br. at 8, 9; P. Br. at 29 - 33. Immediate jeopardy means 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. A resident need not actually be harmed or die in order for there to be immediate jeopardy. Any situation which poses a likelihood for causing serious injury, harm, impairment, or death to a resident is sufficient to constitute immediate jeopardy even if actual harm has not yet occurred. 42 C.F.R. § 488.30l.

The regulations require that deference be paid to CMS in determining when a particular deficiency has resulted in immediate jeopardy. If a facility fails to comply substantially with a participation requirement, and CMS determines that the level of noncompliance is immediate jeopardy, then CMS's determination as to the level of noncompliance must be sustained unless it is established to be clearly erroneous. 42 C.F.R. § 498.60(c)(2). I find that the same conditions already discussed, which should have alerted Petitioner to the need for monitoring Resident 2's acute respiratory distress, are sufficient to establish that this absence of adequate supervision presented an immediate jeopardy to Resident 2's breathing and resulted in his death.

Petitioner contends that "[CMS] produced no evidence whatsoever either that Emerald Oaks committed any act or omission that violates any regulation or standard of care with respect to the incident [Resident 2's acute respiratory distress], or that the Resident suffered any injury as the result of Nurse Parker's [she peeked into room] actions." P. Br. 30, 31. I was struck by the strength of the convictions that Ms. Boutiellier, the SCFD crew member, expressed at the hearing when she recounted the inadequate medical treatment that Resident 2 was receiving for his acute respiratory distress. Tr. 277 - 289. The resident was critical. Tr. 285. Ms. Boutiellier was not only outraged that none of Petitioner's staff was in with the Resident after placing a call to 911, but that the treatment that was provided was inadequate. Id. According to Ms. Boutiellier, the resident was suffering from a serious lack of oxygen. Tr. 278, 281. The oxygen in Resident 2's blood was only 84 percent, which was far below a healthy level. Tr. 279. Ms. Boutiellier found that Petitioner's staff was administering oxygen to Resident 2 at only five liters per minute, which was not nearly enough to treat the resident's problem. She administered high-flow oxygen. Tr. 278, 279, 283.

Even when Petitioner's staff showed up, Ms. Boutiellier found that the staff did not have adequate information about the resident's condition - for example, Petitioner's staff did not give the resident Tylenol for his fever because the staff did not know that his fever was 105 degrees Fahrenheit. Tr. 280, 281. Ms. Boutiellier was left with no choice but to intubate the resident, inserting a tube down his throat so he could breathe sufficiently to be transported to an emergency room. Tr. 284, 285, 288. Ms. Boutiellier testified that she believed that Resident 2's fever, dark urine, fluid-filled lungs and other obvious signs of illness had been present for at least an hour before her arrival. Tr. 279, 281. Ms. Boutiellier also believed that Resident 2 was dying by the time she arrived to treat him. Tr. 286. I do not agree with Petitioner when it states that "the SOD plainly and simply imputes to Emerald Oaks regulatory responsibility for nurse Parker's personal failure to respond to what turned out to be an emergency." P. Br. at 31. Petitioner simply does not accept responsibility for the fact that, as a facility, it failed to provide prompt and continuous care for Resident 2's acute respiratory distress. CMS Ex. 2 at 1 - 3.

The proof of immediate jeopardy lies not in the simple fact that Resident 2 died, but in the fact the Petitioner's failure to supervise him adequately to avert acute respiratory distress placed Resident 2 in a position that was extremely dangerous. In other words, even if he had been fortunate enough to have received some assistance without suffering serious injury, he would still have been placed in immediate jeopardy of serious harm to his health and safety. I find that the provider was not in compliance with Medicare participation requirements; as a result, I find that there was immediate jeopardy. I therefore conclude that CMS was not clearly erroneous in determining that immediate jeopardy was present. 42 C.F.R. § 498.60(c)(2).

Finding 3. A per-instance CMP of $10,000 was reasonable in light of all the circumstances.

Section 1819(h)(2)(B) of the Act provides statutory authority for imposing CMPs against long-term care facilities that do not comply substantially with Medicare participation requirements. This section provides that CMPs shall be applied against noncompliant facilities in the same manner as CMPs are applied under the Civil Money Penalties and Assessments Act, section 1128A of the Act. Both sections 1819 and 1128A are remedial statutes. Their purpose is not to punish wrongdoers but to induce compliance with the requirements of law. Any CMP that is imposed against a long-term care facility must be consistent with this remedial purpose.

Petitioner's noncompliance established a basis for CMS to impose a per-instance CMP in the amount of $1,000 - $10,000 and it was reasonable to impose a per-instance CMP of $10,000 against Petitioner. 42 C.F.R. §§ 488.402(b), 488.438(a)(2). Factors that may be considered which may affect the amount of the CMP include: (1) the facility's history of noncompliance; (2) the facility's financial condition; (3) the factors specified in 42 C.F.R. § 488.404; and (4) the facility's degree of culpability. 42 C.F.R. § 488.438(f).

Petitioner cites Kelsey Memorial Hospital, DAB CR583 (1999) in support of its claim that I cannot uphold the CMP without proof that CMS considered all the regulatory factors at 42 C.F.R. § 444.438(f). In that case, although Judge Leahy found neither the state agency nor CMS properly considered the factors, she nevertheless proceeded to conduct a de novo analysis of the factors and ultimately upheld the CMP in its entirety. Id. at 92 - 97. Similarly, I am not obligated to presume that CMS correctly assessed the evidence and factors in setting the amount of the CMP, but I am bound to make an independent determination of whether the amount set by CMS is reasonable based on the evidence as fully developed in the hearing. CarePlex of Silver Spring, DAB No. 1683 at 18 (1999), citing CarePlex of Silver Spring, DAB CR536 at 14 (1998).

I have considered all these regulatory factors in this case. Several had no bearing here. At no time during the hearing, did Petitioner argue that its financial condition was precarious and that it could not afford to pay the $10,000 per-instance CMP. Petitioner is owned and operated by Beverly Corporation and Petitioner has neither suggested nor shown that it would be put out of business by paying a $10,000 CMP. See Kelsey Memorial Hospital, DAB CR583 at 95 (1999). Factors specified in 42 C.F.R. § 488.404 and the degree of Petitioner's culpability establish the reasonableness of its CMP.

Petitioner argues that 42 C.F.R. §§ 488.404 and 488.438(f) set forth a series of factors that CMS "must . . . take into account" in "determining the amount of the penalty." P. Br. at 33. Petitioner contends that CMS offered no witness to address these factors and that there is no documentary exhibit in the record that purports to address them. Id. Petitioner believes that CMS should be held accountable for why it "rejected the recommendation of the SSA [state survey agency] and increased the severity of the deficiency and penalty. Id. at 33, citing CMS Ex. 9 at 2. Petitioner contends that SSA cited the deficiency relating to Resident 2 at scope and severity level "G" and recommended to CMS that it should impose a "per diem" CMP. P. Br. at 33, citing P. Ex. 82; Tr. 379. Moreover, Petitioner contends that since no CMS witness addressed the issue, Petitioner had no opportunity to inquire about the basis for the CMP. Id.

I do not agree with Petitioner's contentions. Whether or not CMS has failed to fully review Petitioner's financial condition prior to making a determination to impose CMPs in this case is not a relevant consideration for me in deciding the amounts of the CMPS to be imposed if I give Petitioner the opportunity to present such evidence as part of its case before me. See Hermina Traeye Memorial Nursing Home, DAB CR756 at 45 (2001).

In any case involving imposition of CMPs, my authority to determine the reasonable amounts of penalties derives both from the Act and from implementing regulations. That authority constitutes de novo review authority in which I must decide in those cases where a basis exists for imposing CMPs, what penalty amounts are reasonable. I decide this independent from any determination made by CMS or any recommendation that is made by a State survey agency. In reaching a decision as to the reasonable amounts of CMPs, I am authorized expressly to hear and rule on evidence that relates to all of the factors that CMS may consider in making its initial determination. 42 C.F.R. § 488.438(e)(3). Those factors are specified at 42 C.F.R. § 488.438(f) and at 42 C.F.R. § 488.404, which is incorporated into 42 C.F.R. § 488.438(f) at 42 C.F.R. § 488.438(f)(3).

Petitioner's degree of culpability demands a severe penalty. The regulatory concept of culpability is defined as: "[it] includes, but is not limited to, neglect, indifference, or disregard for resident care, comfort or safety." 42 C.F.R. § 488.438(f)(4).

In a CMP case, a long-term care facility potentially bears an additional burden of proof where it challenges the level of the deficiency determined by CMS. The facility must prove that CMS's determination of the level of noncompliance is clearly erroneous if the record of the case establishes that the facility is not complying substantially with a participation requirement that is the basis for CMS's CMP determination. 42 C.F.R. § 498.60(c)(2). The facility would not have to meet this additional burden in a case where it was able to prove by a preponderance of the evidence that it was complying substantially with the participation requirement or requirements on which CMS premised its CMP determination. See Cross Creek Health Care Center, DAB CR504 (1997).

I conclude that a per-instance CMP of $10,000 is reasonable in this case.

Finding 4. Petitioner was not in substantial compliance with the participation requirement at 42 C.F.R. § 483.13(c)(1)(i) during the October 2000 survey with respect to CMS's finding of a deficiency at Tag 224, as it relates to Resident 10.

The SOD alleges that Petitioner failed to comply substantially with the requirements of 42 C.F.R. § 483.13(c)(1)(i). P. Ex. 1 at 1 - 5. Petitioner admitted Resident 10 on September 30, 2000 with several diagnoses including new onset convulsions, cerebral vascular disease, urinary tract infection, cardiac arrhythmia, anemia, constipation, pain, edema, senile dementia, and insomnia. P. Ex. 1 at 1, 2. The admission record for Resident 10 indicates also that he had myelomonocytic leukemia. CMS Ex. 15 at 5; P. Ex. 1 at 2. The SOD contained some of the following findings:

•nursing note on October 18, 2000 indicated that the resident was getting confused while playing cards, which was out of character for him. Id. Vital signs of the resident were assessed; however, the resident's physician was not notified of the change in his condition. Id.

•note dated October 18, 2000, indicated "RES found oob (out of bed) amb (ambulating) in room-increased confusion. Id.

•two nurses' notes on October 19, 2000 indicated that the resident's confusion continued and that he had complained of a headache. The resident's physician ordered a urine analysis, which was negative for infection. Id.

•note dated October 20, 2000 at 5:45 a.m. indicates "pt. (patient) found lying across bed, respirations 40, and deep, BP 200/100, skin cool and calmly [sic]. HR (heart rate) 133." P. Ex. 2 at 2 - 3. Resident did not register to name being called and the episode lasted 20 seconds. There is no documentation that the doctor was called. Id. at 2, 3.

•nurse note at 9 am on October 20^th indicated that resident was lying across bed on his back having a generalized seizure, which subsided after approximately one minute. After being notified by a nurse, the physician sent the resident to the hospital for evaluation. Id. at 3.

•October 23, 2000 at 11:30 am the resident was returned to the facility. Id.

•nursing note at 1:30 p.m. on October 23^rd revealed that the resident was "found on floor . . . hematoma on l (left) forehead, open area under eye-numerous skin tears on arms." The resident was transferred to the hospital and readmitted on October 23^rd at 9:30 p.m. Id.

•note of October 24, 2000 at 3:30 a.m. indicates that the resident was found on the floor by the side of the bed. "Tabs unit intact on head of bed, gown off, pt alert, verbalizes approximately. ROM (range of motion) within normal limits, pupils equal, reactive and respond to light." No documentation that the physician was notified. Id.

•note on October 24^th at 5:30 a.m. indicates that the resident remains on one hour check and was found on the floor by the door. Skin tears were noted on the right upper arm. No documentation that the physician was notified. Id.

•documentation indicates that the physician was notified of incidents regarding this resident via answering service at 8:00 a.m. (4 ½ hours after the first fall). The notation at 9 a.m. indicated the physician's office was called and the facility was told that the physician was on vacation. At 9:15 a.m. call was placed to the on-call physician. Id. at 4.

•October 25, 2000 at 12:10 p.m., observation revealed that the resident's room was located half-way down the hallway from the nursing station and the resident's room was located inside a pod with three other rooms. The resident was sitting in a straight back chair in the room, chomping his jaws. Upon standing, the resident fell backwards into the chair with the back of his head hitting the wall. The surveyor yelled for help, and the resident became unbalanced and fell into the chair, hitting his head against the wall again. A nurse arrived and she pulled a 50-cent size of torn plastic from the resident's mouth. Id.

•administrator indicated that the facility planned on moving the resident to another room closer to the nursing station. Id.

•observation of the resident on October 25^th at 1:20 p.m. revealed that he was not in his room. Interview with the staff nurse indicated that the resident had a seizure (approximately one hour after the resident fell into the chair and hit his head); the medical director, who was in the facility, was notified and evaluated the resident and had the resident sent to the hospital for further evaluation. Id. at 5.

Petitioner believes that CMS's recitation of the circumstances relating to Resident 10's decline are "breathtakingly incomplete and misleading." P. Br. at 6. For some reason, Petitioner believes that Deborah Haywood, the surveyor who cited the deficiency, was unaware that the resident was terminally ill with end-stage leukemia and "that she could not possibly have put her observations into appropriate context." P. Br. at 6; Tr. 141, 142. With regard to this resident's injuries, Petitioner would have me believe that the "risk plainly was caused by his [Resident 10's] deteriorating medical condition, not any act or omission by Emerald Oaks." P. Br. at 6. Moreover, Petitioner states that on October 23, with checks on this resident at least every hour, the resident again was found on the floor twice during the night. P. Br. at 8; P. Ex. 19 at 4, 5. Ms. Repchick, the Administrator at Petitioner's facility, testified that she was made aware of the overnight falls and that she and her staff immediately began planning and implementing interventions to address the resident's deteriorating condition. Tr. 470 - 472; P. Br. at 8; P. Ex. 20.

Petitioner was cited for a deficiency because of its failure to provide Resident 10 with the degree of supervision to prevent foreseeable, potential physical harm. Tr. 100 - 114, 118, 165; CMS Ex. 11 at 1 - 5. Based on surveyor Haywood's observations, Petitioner's nursing staff should have contacted Resident 10's physician immediately at 4:45 a.m. on October 20^th, when the resident first evidenced seizure-like activity. Tr. 103, 104, 144, 145. Based on surveyor Haywood's 28 years of nursing, she believed that resident 10's symptoms could have been associated with seizures and that his blood pressure of 200/100 could have indicated that he was having a stroke. Tr. 104, 145. Since this resident's admitting diagnoses include CVA (stroke), it would have been reasonable for surveyor Haywood to believe this resident had a stroke. Moreover, Petitioner's staff waited more than four hours before calling Resident 10's physician - the call was made in response to the resident's second episode of seizure-like activity. The resident's physician immediately transferred him to the hospital, and it may reasonably be assumed that the resident would have been hospitalized 10 hours earlier if Petitioner had promptly reported the resident's first seizure-like episode.

I conclude that Petitioner's actions exposed Resident 10 to much more than minimal harm because Resident 10 could have suffered very rapidly from the untreated effects of a seizure or stroke. Petitioner's failure to act on information available at the time is not excused because Resident 10 appeared not to suffer severe, irreparable harm. Both surveyor Haywood and CMS's expert witness, Dr. Susan Acker, indicated that Resident 10 was exposed to a risk of serious harm by Petitioner's failures to provide the resident with an acceptable level of supervision and monitoring. Tr. 110 - 114; 165, 369 - 371. During the time that surveyor Haywood observed Resident 10, he struck his head twice; surveyor Haywood testified that this trauma could have triggered more seizures. Tr. 107, 108. Regarding the 50-cent sized piece of plastic Resident 10 was chewing on, surveyor Haywood concluded that he faced a "very high" risk of choking on the plastic lid and dying of respiratory arrest. Tr. 102, 112, 113. Petitioner did not take steps to appropriately monitor Resident 10 and he was exposed to a high risk of significant harm for which Petitioner was properly cited at Tag 224.

Finding 5. Petitioner was in substantial compliance with the participation requirement at 42 C.F.R. § 483.13(c)(1)(i) during the October 2000 survey with respect to CMS's finding of a deficiency at Tag 224, as it relates to Resident 5.

Resident 5 was admitted to Petitioner's facility on September 29, 2000 with Alzheimer's (Stage 3) and history of gastrointestinal bleeding and was discharged three days later. P. Ex. 5 at 5. The SOD alleges that Petitioner failed to comply substantially with the requirements of 42 C.F.R. § 483.13(c)(1)(i). CMS Ex. 2 at 1.

According to the SOD, an interview with the resident's daughter on October 24, 2000 revealed that on September 30, 2000 at 10:45 a.m., she called the resident and the resident indicated that she was lying in her own feces. CMS Ex. 5 at 5. The resident indicated that she had tried to get four nurses to assist her and was ignored. The daughter called the nurses' station and she was told someone would clean up Resident 5. At 11:50 a.m. that day, the resident's son visited and he stated that his mother was still lying in her feces. Id. When the son asked the nurse giving his mom medication to find a CNA, he was told that there were none and the one working was at lunch and the nurse was there just to give medicine. The son then went to the nursing station to get someone to clean his mother. Id. Resident 5's son filed a grievance regarding these events, which was corroborated by Petitioner. P. Ex. 43 at 1.

On October 1, 2000, Resident 5 called her daughter and stated "I have blood all over and shit all over." P. Ex. 5 at 5. The resident had a nose bleed. The facility discussed the resident's condition with her family and the family transferred the resident to another facility that day. Id.

CMS argued that the "harm associated with Petitioner's leaving Resident 5 unattended in fecal waste is more than minimal." CMS Br. at 27. Moreover, CMS claimed that "Resident 5 suffered the indignity of begging for help unsuccessfully for more than an hour while lying in her own feces; this exposed to her to mental anguish fitting the regulatory definition of neglect." Id. Petitioner would have me believe regarding this resident that "[o]n its face, this citation is trivial. While the Resident's repeated episodes of incontinence and a nosebleed no doubt were unpleasant, there is no evidence that the Facility failed to respond to them appropriately." P. Br. at 11. Petitioner does, however, have a legitimate argument when it states that Resident 5's family's complaint is based on their accounts of the events, "without any corroboration whatsoever." P. R. Br. at 5.

Certainly, what is evident on review of these revelations by the resident's children of alleged noncompliance by Petitioner is that most of the allegations are hearsay. However, the hearsay that CMS relies on to support the findings made under Tag 224 regarding Resident 5 is reliable and has some probative value. First, CMS identified the resident through the SOD, so Petitioner was in a position to not only identify the resident before the hearing, but Petitioner was also in a position at the hearing to test the accuracy of the statements that the survey report attributes to the family members of this resident and to test the credibility of those statements.

On the other hand, it is true that the surveyors who conducted the October 2000 survey could have made efforts to verify the allegations that were attributed to residents and family members. For example, they could have tested the assertion that this resident was not being assisted in using the bathroom by inspecting the resident and the bed linens. However, CMS offered no evidence to show that they surveyors made such an inspection or that they found any examples of residents lying in soiled linens. The surveyors could have looked for other physical evidence that supported the allegations that were attributed to residents or family members, such as accumulations of urine or feces at the facility. In sum, CMS offered no evidence to show that the surveyors searched for such evidence or that they found it.

Furthermore, CMS offered no evidence to demonstrate the presence of any of the consequences that one might expect if, in fact, the staff had neglected to attend to the resident's bowel and bladder needs. It offered no evidence to show, for example, that the resident suffered pressure sores as a consequence of neglect of the resident's bowel and bladder needs by staff, or that there was an elevated rate of urinary tract infections at Petitioner's facility. Some of the allegations that are made under Tag 224 are based on family interviews, observations, and review of Petitioner's records by surveyors. These consist of the observations that were made concerning Resident 5's demands to be assisted to the bathroom or to be cleaned up after being incontinent. However, while these observations may have been accurate, CMS failed to produce evidence that the potential for even minimal harm existed in the manner in which Petitioner's staff dealt with Resident 5.

Finding 6. Petitioner was not in substantial compliance with the participation requirement at 42 C.F.R. § 483.13(c)(1)(i) during the October 2000 survey with respect to CMS's finding of a deficiency at Tag 224, as it relates to Resident 12.

The resident was admitted to the facility on June 29, 2000 with spinal stenosis, fusion of C3 - C6 (cervical) and neurogenic bladder. P. Ex. 1 at 5. An interview with three family members revealed that since Resident 12's admission, they had come in to visit daily and noticed that she was not being showered for over seven days. Id. at 6. Two weeks prior to their complaint of October 26, 2000, they found the resident sitting in a dry brief but the pad under her was soaked in urine and dripping onto the floor. They stated, "[w]e have found her lying in urine multiple times when we came in, even her pillows will be soaked." Id. The family indicated that a sister-in-law, who is a registered nurse, has had to come in and shower the resident. Her son related that he pulled a call bell and waited and the CNA answered the light and said, "I'll be back" and never came. He stated, "I had to change my mother myself." Id.

Interview of this resident on October 26, 2000 revealed that, "I turn on light. The CNA's turns off my light and says she'll come back. Then I wet myself. I feel bad. I have to sit in wet clothes and pads for hours." Id.

Record review of the care plan revealed: toilet before and after meals, activities, bed times, and upon rising as needed. Id.

One of Resident 12's daughters told surveyors about several problems regarding the resident's care. Tr. 173 - 176; CMS Ex. 11 at 6. She recounted having found her mother sitting in urine. Tr. 176, 177. This same daughter stated that her mom told her that she used her call light to seek assistance, but no one responded. Tr. 177. Her daughter stated that her mother does not urinate on herself while visiting her in her home because she takes her mother to the bathroom whenever she requests it. Tr. 178.

There is harm attributed with leaving a resident, such as Resident 12, sitting or lying unattended in her own urine which is more than minimal. Resident 12's care plan stated that she was at risk for impaired skin integrity because of incontinence. CMS Ex. 16 at 17. Moreover, Resident 12 was exposed to the indignity of sitting in urine-soaked clothes because Petitioner did not respond to her requests for assistance with toileting; she was not showered for as many as seven days at a time, resulting in her being dirty and rank just before her birthday party on October 24^th. Tr. 173 - 175; CMS Ex. 11 at 6. These events exposed Resident 12 to mental anguish, constituting neglect and noncompliance at Tag 224. 42 C.F.R. § 488.301.

An interview of Resident 12 on October 26, 2000 also revealed that at 11:00 a.m., the resident was being showered by a CNA and the resident's foot slipped, because the CNA was unable to hold her up and she fell to the floor, cutting her head open. P. Ex. 1 at 6. The CNA reported the incident as the resident was being left sitting on the toilet with the shower running and when the CNA left the bathroom to get clothes, she heard a thump and returned to find the resident on the floor. Id. A later interview with the CNA by the Administrator revealed that the resident was in the shower and fell. The surveyor did go to the resident's room at 3:10 p.m. and there was still blood in the shower room. Id. EMS (Emergency Medical Service) was called but the resident was not transferred by EMS. Id. at 6, 7. Interview of the resident at 3:20 p.m. revealed that she did not refuse to go to the hospital. Record review of nursing note revealed that at 1:45 p.m, "[n]euro check WNL (within normal limits). Legs weak." Id. at 7. At 3:15 p.m., the surveyor observed the resident with no dressing on head wound, crusted blood throughout her hair, and continued oozing of laceration of resident's head. Id. As a result of surveyor intervention, the resident was sent to the Emergency Room where her head was sutured closed. Id.

Both of Resident's 12's daughters indicated that Resident 12 required a shower chair for bathing because of her weak legs. Tr. 174, 195. Both of these witnesses stated that a CNA told them that she tried to shower Resident 12 without a shower chair. Tr. 179, 180, 181, 183, 184, 199 - 201. According to Resident 12's daughters, the CNA told them that because she could not locate a shower chair, she assumed Resident 12 could be showered while standing with a walker and holding onto a grab bar. Tr. 184, 200, 201.

On October 26^th, Resident 12 suffered a head injury, which once again illustrates Petitioner's failure to render necessary services to its residents. CMS Ex. 16 at 9. According to this resident's children who testified, the CNA said that she could not locate a shower chair and that she assumed Resident 12 could be showered while standing with a walker and holding onto a grab bar. Tr. 184, 200, 201. Resident 12 slipped and feel when the shower water was turned on, and she suffered a head laceration that required sutures. Tr. 180, 183, 195, 200; CMS Ex. 16 at 9; P. Ex. 65 at 2, 3.

A review of the Care Plan for Resident 12 reveals that the resident is at risk for falls with the goal of: "[w]ill have no fall related injuries as evidenced by ns. (Nursing) notes. Monitor for safety and steadiness. Encourage use of assistive device when ambulating." Id. There was no shower chair in the room or provided by the CNA to assist this resident in preventing a fall during her shower. Id. A random interview of three CNAs (Certified Nursing Assistants) on October 26, 2000 at 9:50 a.m. revealed that "[w]e do not have enough shower chairs to bathe residents." Id.

Petitioner was on notice that Resident 12 was to be monitored for falls, as is evidenced by her care plan. P. Ex. 1 at 6, 7. Thus, Petitioner had an objective to make sure that Resident 12 did not sustain any "fall-related injuries." Id. Petitioner should have known that putting Resident 12 in any situation where she had to rely on strength in her legs could possible cause her harm and lead to a major or minor injury because of this resident's weak legs. If the facility's goal was to "[e]ncourage use of assistive device when ambulating [Resident 12]" then Petitioner should have known that showering Resident 12 without a shower chair could lead to an unwelcome, even dangerous outcome. Petitioner's attempt to shower Resident 12 without use of a shower chair is more than minimal harm. Petitioner's treatment of Resident 12 constituted neglect and noncompliance at Tag 224. 42 C.F.R. § 488.301.

Finding 7. Petitioner was not in substantial compliance with the participation requirement at 42 C.F.R. § 483.20(k)(3)(i) during the October 2000 survey with respect to CMS's finding of a deficiency at Tag 281, as it relates to Resident 5.

Pursuant to Medicare requirements found at 42 C.F.R. § 483.20(k)(3)(i) (survey tag prefix F281), the services provided by nursing facilities, such as Petitioner's, must meet "professional standards of quality."

Resident 5 suffered from gastrointestinal bleeding and was hospitalized for that condition immediately before her admission to Petitioner's facility on September 29, 2000. CMS Ex. 13 at 31- 33. Dr. Harris signed various orders written by Resident 5's hospital physician (Dr. Tamra), directing Petitioner's staff to do the following for Resident 5: (1) Hemoccult all stools, notify doctor if gross bleeding or persistent positive stools; (2) administer the medication Aricept in a 10 mg dosage, once per day; and (3) administer Calcium in a 500 mg dosage, twice per day. CMS Ex. 13 at 6; P. Ex. 31 at 1. The treatment order to Hemoccult all stools was not followed, and no Hemoccult test results were entered in Resident 5's chart. Tr. 294; see also CMS Ex. 13 at 23 - 25. The Aricept and Calcium orders were erroneously entered in Resident 5's chart, resulting in the resident getting an overdose of Aricept and an underdose of Calcium. CMS Ex. 13 at 6, 8, 9, 13, 20, 21. Surveyor Penczykowski testified that Resident 5 and other residents were exposed to serious harm by Petitioner's continuing systemic failure to properly transcribe medication orders and correctly deliver medications to residents. Tr. 300, 302. Depending on the type of medication misdelivered, Petitioner's systemic failures could have resulted in a resident's death. Tr. 302.

Resident 5's orders for Aricept and Calcium were transcribed improperly. For the period September 29 - 30, 2000, Resident 5's computerized printout of physician orders incorrectly specifies that the resident should be given two doses of Aricept per day and one dose of Calcium per day. CMS Ex. 13 at 8, 9. On October 2, 2000, a nurse signed the computerized printout verifying the accuracy of the Orders. Id. at 11. For the period October 1 - 31, 2000, Resident 5's computerized printout of physician orders specifies that the resident should be given the erroneous two doses of Aricept and one dose of calcium. Id. at 13. Three of Petitioner's staff members signed the printout verifying the accuracy of the orders. Id. at 16.

Petitioner labels this cited deficiency as "peculiar." P. Br. at 22. Petitioner contends that:

[t]here appears to be no question that either the Resident's handwritten medication order was transcribed incorrectly onto the computer, or the computer made an error when rolling over the September orders to October, and that as a result on October 1, the Resident received one calcium table rather than two, and two Aricept tablets rather than one. P. Ex. 33, 34, 37. However, there also appears to be no dispute that neither error caused the resident any harm, or even the potential for any harm.

Id. Surveyor Penczykowski compared the Aricept and Calcium errors to Petitioner's purported Quality Assurance system, which was supposed to ensure the proper transcription and execution for medication orders. Tr. 297 - 299. Surveyor Penczykowski talked with one of Petitioner's nurses, who stated that she and others verified the accuracy of all physician orders entered in residents' charts since September 5^th. Tr. 300, 301, 324 - 329. The nurse claimed that orders had been verified every day, including weekends. Tr. 329⁽²⁾.

Nonetheless, Resident 5's orders for Aricept and Calcium were transcribed improperly. Surveyor Penczykowski testified that Resident 5 and other residents at Petitioner's facility were exposed to serious harm by Petitioner's continued systemic failure to properly transcribe medication orders and correctly deliver medications to residents. Tr. 300, 302. Depending on the type of medication misdelivered, Petitioner's systemic failures could have resulted in a resident's death. Tr. 302.

The survey of October 26^th was a revisit survey and Petitioner's burden was to prove that its allegation of compliance at Tag 281 could be substantiated. See Kelsey Memorial Hospital, DAB CR583 at 55 - 56 (1999); Mediplex of Massachusetts, Inc., DAB CR584 at 7 (1999). Moreover, on October 1^st, one day after Petitioner allegedly achieved compliance with Tag 281effective September 30^th, Resident 5 received incorrect doses of Aricept and Calcium, even though several of Petitioner's staff members signed documents verifying the accuracy of transcribing and carrying out physician orders for the Aricept and Calcium. CMS Ex. 13 at 8, 9, 11, 13, 16; CMS Ex. 10 at 5. Thus, the potential for serious harm was evidenced by Petitioner's continued pattern of errors in administering medications. The fact that Resident 5 was not physically harmed by misadministration of Aricept and Calcium is not dispositive. See Mediplex, CR584 at 9. The potential harm laid in Petitioner's propensity to misadminister medications to residents. See id. (upholding jeopardy-level deficiency despite resident's not being physically harmed by misadministered medications).

Surveyor Penczykowski testified regarding Petitioner's noncompliance, which represented a violation of a basic professional standard of nursing - nurses must follow physician orders. Tr. 293, 297. The surveyor also testified about the result of harm associated with Petitioners's failure to perform Resident 5's Hemoccult tests. The Hemoccult test is used to detect blood in a patient's stools that cannot be detected by visual inspection and it is a relatively simple test requiring a few moments to take stool samples and apply chemical agents to them. Tr. 293. The Hemoccult test was ordered for Resident 5 based on her history of serious gastrointestinal bleeding, to identify bleeding in her intestinal tract before she experienced the serious effects of blood loss and anemia. Tr. 294, 296.

Resident 5's medical chart indicated that she passed at least seven stools while in Petitioner's care, but only three stool samples were obtained on October 2.⁽³⁾ CMS Ex. 13 at 25, 29 - 30. Petitioner had no evidence indicating that these or any other stool samples were subjected to a Hemoccult test or that any sample had been sent to an outside laboratory for such testing. Tr. 295, 308, 309. No Hemoccult test results were found in Resident 5's chart. Id. Petitioner's failure to ensure that Hemoccults were completed exposed Resident 5 to much more than minimal harm; the resident could have suffered bleeding in her intestinal tract, for which she recently had been hospitalized, and such bleeding could have remained undetected and untreated. Tr. 295, 296.

Finding 8. Petitioner was not in substantial compliance with the participation requirement at 42 C.F.R. § 483.20(k)(3)(i) during the October 2000 survey with respect to CMS's finding of a deficiency at Tag 281, as it relates to Resident 8.

Resident 8 was admitted to the facility on December 12, 1999 with a diagnosis including: gastritis, seizure disorder, ischemic cerebrovascular disease, and gastrostomy tube placement. The resident was receiving Enteral nutrition of Jevity with fiber, 250 calorie per 8 fluid ounces, 80 cc per hour, on a continuous basis. The Jevity is supplied in individual 8 fluid ounce cans and administered through a refillable bag system. During the resident's room review on October 25, 2000, at approximately noon, the surveyor noted that the tube feeding was infusing per pump. Observation of the tube-feeding bag revealed that date the administration bag was opened was October 23, 2000. Interview with the charge the nurse revealed that all tube-feeding bags are changed every 24 hours on the night shift. P. Ex. 1 at 12; Tr. 220, 221, 302 - 306; CMS Ex. 14 at 5, 6. The surveyor concluded that the feeding bag had not been replaced for more than 48 hours because it was dated October 23, 2000 by the night shift nurse who opened it. Tr. 303. Generally the night shift runs from 11:00 p.m. to 7 a.m.;⁽⁴⁾ nursing practice would require changing and dating the feeding bag sometime after midnight; i.e., a bag dated October 23 would have been opened sometime between 12:00 a.m. and 7:00 a.m. on October 23. Tr. 306 - 308.

With 22 years of nursing experience, Surveyor Penczykowski testified that Petitioner violated a professional standard of practice requiring that disposable feeding bags should be replaced every 24 hours. Tr. 292, 304. Surveyors Penczykowski and Sullivan testified that the Lippincott Manual of Nursing is a widely regarded authoritative source of information about nursing practice. Tr. 45, 304, 305. The Lippincott Manual directs nurses to change tube feeding bags every 24 hours, in order to limit bacterial contamination. CMS Ex. 23. Petitioner's written policy required the same rate of change. Surveyor Penczykowski's unrebutted testimony established the risk of more than minimal harm associated with Petitioner's failure to change Resident 8's feeding bag; refilled feedings bags must be changed to prevent bacteria from growing in them. Tr. 305. Bacteria growing in feeding bags can infect nutrition solutions poured into the bags, creating a risk of food-borne illness for tube-fed individuals. Tr. 305, 306. Surveyor Penczykowski testified that Petitioner's actions created a risk of food-borne illness for Resident 8, which could have caused the resident to experience stomach cramps, diarrhea, or vomiting. Id. Vomiting was particularly dangerous for Resident 8 as he had difficulty swallowing and he could have aspirated his vomit into his lungs and developed pneumonia. Tr. 305, 306. Petitioner's failure to change Resident 8's feeding bag for more than 48 hours constituted noncompliance with F Tag 281.

Finding 9. Petitioner was not in substantial compliance with the participation requirement at 42 C.F.R. § 483.20(k)(3)(i) during the October 2000 survey with respect to CMS's finding of a deficiency at Tag 281, as it relates to Resident 10.

Resident 10 was admitted to the facility on September 30, 2000 with the diagnosis of new convulsions , stroke, and urinary tract infection. The resident was readmitted to the facility on October 25, 2000 at 6:09 p.m. Review of the clinical record the next morning at 9:15 a.m. indicated that an emergency room physician progress note documented the following: "seizure breakthrough, fever 101.8 no source, urinary retention-800 cc's grossly bloody urine." The physician ordered: "hospice consult, add phenobarbital 60 mg HS." P. Ex. 1 at 8.

The nursing notes revealed no assessment of the resident's urinary status, although he had urinary retention (unable to urinate) in the emergency room. Id. The last note was dated October 26, 2000 at 12:14 a.m., documented by the 3-11 p.m. shift nurse. Interview with the Director of Nursing at 9:30 a.m. confirmed the same.

Review of the Medication Administration Record revealed the phenobarbital was scheduled for 9 a.m. although the emergency room physician ordered the phenobarbital to be given at "hour of sleep" for the breakthrough seizures. Id. at 8, 9. Another seizure medication was being given in the morning. Id. at 9. During the interview with the 7 a.m. to 3 p.m. nurse, the nurse confirmed that she would likely give the phenobarbital during her medication pass at 9:00 a.m. because that was the scheduled time on the MAR [Medication Administration Record]. The surveyor intervened and the medication was not given.

Interview with the nurse who noted and transcribed the order to the MAR stated that she took the order off the discharge instructions from the emergency room which indicated: "phenobarbital 60mg one tab daily. The procedure at the facility is to schedule daily medications to be given at 9 a.m." P. Ex. 1 at 8, 9. When questioned regarding why she took the order from the discharge instruction sheet versus the physician progress note or why she did not call the physician for clarification, she had no response.

During a telephone conversation with the Medical Director on October 27, 2000 at 6:00 p.m., the physician confirmed the issue regarding the nurse not clarifying the resident's medication was a "serious issue" and he would have wanted to have been notified. Id.

Surveyor Haywood testified that Petitioner's staff violated a fundamental nursing standard of practice - nurses are obligated to clarify ambiguous information regarding patient care, so they can ensure that physician orders are implemented properly. Tr. 125.

Petitioner received, reviewed, and added to Resident 10's chart two documents specifying that Resident 10 should be given phenobarbital; it disregarded information on one of the forms, specifying that the phenobarbital should be given at night.⁽⁵⁾

The potential harm in Petitioner's treatment of Resident 10's emergency room documents was much more than minimal. Resident was diagnosed with "breakthrough seizures," indicating his seizures were not being controlled by his current medication, Dilantin, which was being given in the morning. CMS Ex. 15 at 27; Tr. 120. Petitioner received a written indication that Phenobarbital should be given to Resident 10 at night and Petitioner's nursing staff decided not to follow this indication and not to discuss it with a physician before Surveyor Haywood intervened. P. Ex. 1. The potential harm to Resident 10 was that he may not have gotten the Phenobarbital's full therapeutic benefit if it was given in the morning and his seizures might have continued unabated. Tr. 125, 126. Dr. Harris did not deny this possibility; he admitted that he did not know whether it made any difference for Resident 10's phenobarbital to be given at a different time of day. Tr. 231. Dr. Harris did defer to the emergency room's instructions to give the phenobarbital at night. CMS Ex. 15 at 22, 27.

Petitioner's decision to ignore important clinical information regarding Resident 10's phenobarbital order, as well as its failure to discuss this information with a physician before administering the drug, makes me conclude that Petitioner was properly cited for noncompliance at Tag 281for actions regarding Resident 10's medication.

VI. Conclusion

In summary, Petitioner failed to prove by the preponderance of the evidence that it was in compliance with the cited requirements in the May 2000 survey and further failed to show any clear error in CMS's assessment that the situation constituted immediate jeopardy to resident health and safety. CMS has a basis to impose a per-instance CMP of $10,000, which is reasonable under all the relevant circumstances, as is the termination of Petitioner from the Medicare program.

Marion T. Silva

Chief Administrative Law Judge

1. CMS contracts with state health agencies to conduct surveys of nursing homes' compliance with Medicare participation requirements. Sections 1864 and 1819(a) of the Social Security Act; 42 U.S.C. § 1395aa; 42 U.S.C. §1395i-3(g); 42 C.F.R. § 488.20.

2. Nurse Shirley Hunziker testifying for Petitioner confirmed that all resident charts had been reviewed either by her or other nurses on a daily basis since September 5, including weekends. Tr. 558, 559, 562, 563.

3. Resident's 5's Activities of Daily Living Flow sheet indicates four bowel movements on October 1, 2000 (CMS Ex. 13 at 29) and nurses notes indicate three bowel movements on October 2, 2000 (CMS Ex. 13 at 25).

4. This customary timing was confirmed during Petitioner's cross-examination of Surveyor Sullivan. Tr. 63.

5. Petitioner's nurse, Cheryl Dodd, confirmed this when she testified that Petitioner reviewed both forms, implemented the phenobarbital order in accordance with the Discharge Instructions and ignored the phenobarbital timing on the Emergency Department Progress Note because the document was unfamiliar. Tr. 607, 608, 613, 614.