Loaddig

SUBJECT:

Rolling Hills Health Care Center,
Petitioner,

Centers for Medicare & Medicaid

DECISION

Rolling Hills Health Center (Petitioner) is a long term care facility certified to participate in the Medicare and Medicaid programs as a provider of services. Petitioner challenges the March 27, 2001 determination of the Centers for Medicare & Medicaid Services (CMS) that it was not in substantial compliance with Medicare and Medicaid participation requirements and that its noncompliance posed immediate jeopardy to resident health and safety. Petitioner also challenges CMS's imposition of a per instance civil money penalty (CMP) of $7,000.

For the reasons set forth below, I conclude that Petitioner was not in substantial compliance with program participation requirements, that its noncompliance constituted immediate jeopardy, and the $7,000 per instance CMP was reasonable.

I. Background

On February 13, 2001, the Kansas Department of Health and Environment (the State agency) completed a complaint survey and determined that Petitioner was not in substantial compliance with the requirement set forth in 42 C.F.R. § 483.25 (Quality of Care). The State agency concluded that Resident 1 (R1) had not received care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being because Petitioner failed to update R1's physician about the decline in his condition over the morning and early afternoon of February 4, 2001. CMS Ex. 4, at 18. CMS agreed, and, by letter dated March 27, 2001, informed Petitioner that CMS also considered this deficiency to constitute immediate jeopardy to resident health and safety. CMS Ex. 1. The letter reminded Petitioner of remedies set forth in the State agency's letter of February 14, 2001: denial of payment for new admissions effective March 4, 2001 and termination, effective August 13, 2001, if substantial compliance had not been achieved by that date. In addition, the letter notified Petitioner of additional remedies: the imposition of a per instance CMP of $7,000 for noncompliance at the immediate jeopardy level.

On April 3, 2001, the State agency revisited the facility and found Petitioner to be in substantial compliance. In a letter dated April 20, 2001, CMS advised Petitioner that CMS would remove the denial of payment for new admissions as of April 3, 2001. CMS Ex. 2.

Petitioner timely requested a hearing. CMS Ex. 3.

On November 12, 2003, I conducted a hearing on the merits of this appeal in Kansas City, Missouri. At the hearing, CMS submitted 21 proposed exhibits, CMS Exs. 1 - 21. Petitioner submitted three proposed exhibits, P. Exs. 1 - 3. These exhibits were admitted into evidence. Tr. at 18. Subsequent to the hearing and at my request, Petitioner submitted a copy of a document referred to at the hearing as a 'vital signs flow sheet.' Tr. at 86, 121. This document is admitted as P. Ex. 4.

II. Statutory and Regulatory Background

The Social Security Act (Act) sets forth requirements for nursing facility participation in the Medicare and Medicaid programs and authorizes the Secretary of Health and Human Services to promulgate regulations implementing the statutory provisions. Act, sections 1819 and 1919. The Secretary's regulations governing nursing facility participation in these programs are found at 42 C.F.R. Part 483.

To participate in Medicare and Medicaid, a nursing facility must maintain substantial compliance with participation requirements. To be in substantial compliance, a facility's deficiencies may pose no greater risk to resident health or safety than 'the potential for causing minimal harm.' 42 C.F.R. § 488.301. A facility's noncompliance constitutes immediate jeopardy if it 'has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident.' Id.

Under the Social Security Act and the 'quality of care' regulation, each resident must receive, and the facility must provide, the necessary care and services to allow a resident to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the resident's comprehensive assessment and plan of care. Act, section 1819(b); 42 C.F.R. § 483.25.

If a facility is not in substantial compliance with participation requirements, CMS has the authority to impose one or more of the enforcement remedies listed in 42 C.F.R. § 488.406, which include imposing a CMP. See Act, section 1819(h). CMS may impose a CMP for the number of days that the facility is not in substantial compliance with one or more participation requirements or for each instance that a facility is not in substantial compliance. 42 C.F.R. § 488.430(a). 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).

In setting the amount of the CMP, CMS considers: (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, which includes neglect, indifference, or disregard for resident care, comfort, or safety. The absence of culpability is not a mitigating factor. 42 C.F.R. § 488.438(f). The section 488.404 factors include: (1) the scope and severity of the deficiency; (2) the relationship of the deficiency to other deficiencies resulting in noncompliance; and (3) the facility's prior history of noncompliance in general and specifically with reference to the cited deficiencies.

CMS bears the initial burden of producing evidence sufficient to establish a prima facie case for each alleged violation of the regulations. CMS must set forth the basis for its determination with sufficient specificity for a petitioner to respond and come forward with evidence related to the disputed findings. The evidence set forth by CMS must be sufficient to establish a prima facie case that CMS had a legally sufficient basis to impose a remedy. In order for a petitioner to prevail, the petitioner must then prove by a preponderance of the evidence on the record as a whole that it was in substantial compliance with the relevant statutory and regulatory provisions or that it had an affirmative defense. Hillman Rehabilitation Center, DAB No. 1611 (1997), aff'dHillman Rehabilitation Center v. U.S. Dept. of Health and Human Services, No. 98-3789 (D.N.J. May 13, 1999); Cross Creek Health Care Center, DAB No. 1665 (1998); Emerald Oaks, DAB No. 1800 (2001).

III. Issues, findings of fact and conclusions of law

A. Issues

The first issue presented by this case is whether Petitioner was in substantial compliance with the program participation requirement set forth at 42 C.F.R. § 483.25. Specifically, did Petitioner's failure to update R1's physician on his condition between approximately 9:30 a.m. and 2:00 p.m., when he died, constitute a failure to provide the necessary care and services to allow R1 to attain or maintain the highest practicable physical, mental, and psychosocial well-being and did this failure pose no greater risk to R1's health or safety than the potential for causing minimal harm? ⁽¹⁾

If I determine that Petitioner was not in substantial compliance, I must also determine whether Petitioner's lack of substantial compliance constituted immediate jeopardy and whether the $7,000 CMP was reasonable.

B. Findings of fact and conclusions of law

I make findings of fact and conclusions of law (Findings) to support my decision in this case. I set forth each Finding below as a separate italicized bolded heading. I discuss each Finding in detail.

IV. Undisputed facts

The following facts are not in dispute.

R1 was admitted to Petitioner's facility on January 2, 2001. CMS. Ex. 4, at 2. At that time, R1 was 83 years old and suffered from 'refractory congestive heart failure due to cardiomyopathy with associated aortic regurgitation, arterioscleortic heart disease and hypertensive heart disease.' CMS Ex. 17, at 2. R1 also suffered from renal insufficiency and had a history of falling. Id. The minimum data set assessment, dated January 6, 2001, indicated that R1 had modified independence with cognitive skills for daily decision making, required supervision with set up help only for dressing, and required limited assistance of one person for ambulation and transfers. CMS. Ex. 4, at 11.

In late January 2001, R1 was enrolled in Heart of America Hospice, a hospice provider with which Petitioner had a contract for services. CMS Ex. 14, at 1. Patients are enrolled in hospice care when they are not expected to live longer than six months. Tr. 150. The hospice plan of care, completed for R1 on January 30, 2001, indicated that R1 was continent of bladder and bowel (P. Ex. 2, at 2, 4, and 5), and described R1 as being 'alert and answer[ing] all questions appropriately' (Id. at 1, 4, 5), as having 'minimum limited mobility' (Id. at 4), and as being 'ambulatory for short distances' (Id. at 5). The plan also reflected that R1 was 'very understanding of progression of disease' (Id. at 1) and stated that 'I've been ready to go for long time' (Id. at 5).

'[D]uring the 8:00 am hr.' (CMS Ex. 6, at 1) of Sunday, February 4, 2001, R1 was accidently given medications prescribed for R2. R1 was given the wrong medications when he asked for his medications in the hallway from a staff licensed practical nurse (LPN). She asked him if he was R2 and he replied yes. R1 and R2 had similarly sounding names and R1 was hard of hearing. Tr. 70 - 74. Subsequently, the LPN answered R1's call light in his room. Since his room was on the side of the hall for which she did not distribute medication, she realized R1 was not R2 and that she had made a medication error. CMS. Ex. 6, at 1; CMS Ex. 4, at 16 - 17.

The medications given in error were Clexa 40 mg tab, Oruvail 200 mg one tab, Aspirin 325 mg one tab, Captopril 12.5 mg one tab; Furosemide 80 mg one tab; Quinidine Gl. 324 mg one tab; Dipyridamole 50 mg one tab; Spironolactone 25 mg one tab; and Metaprolol 50 mg one tab. CMS Ex. 20. Of these medications, only Furosemide was prescribed for R1. Additionally, that day, Petitioner also received medicines that had been prescribed for him by his physician. These medicines were Amiodarone 200 mg one tab; Furosemide 20 mg three tabs; Senekot one tab; and Potassium Chloride 10 milliequivalents. Id. Metaprolol, Quinidine, Furosemide, Captopril, Spironolactone, and Dipyridamole all had the potential to reduce R1's blood pressure. Tr. at 117 - 118.

A nursing notes entry at 8:30 a.m. on February 4, 2001, stated as follows. The nurse found R1 lying in bed on his right side with his feet pulled up, resting quietly. R1 told the nurse that he had fallen out of bed in the night and hit his head. The nurse found no sign of injury. R1 had some shortness of breath on exertion but was able to bear his weight with one standby assist during a transfer. At this time he was incontinent of bladder. CMS Ex. 14, at 2.

A nursing notes entry at 10:15 stated as follows. R1 was sitting in his wheelchair continuing to complain of not feeling well. Again he reported falling out bed and hitting his head but not asking for help. He said it took him half an hour to get off the floor. The nurse did a full body assessment but found no injuries. R1 was able to transfer with difficulty and bear weight on his legs. He seemed confused. His blood pressure was 88/46, his pulse was 64, his respiration 26, his temperature 96.9 orally, his saturated oxygen 95%. CMS Ex. 14, at 3.

A nursing notes entry subsequent to the 10:15 entry described the medication mistake and how it happened. The notes state that Dr. Patel had been notified, and, that at 9:30 a.m., he ordered a complete blood count and Comprehensive Panel, blood pressure hourly, and monitoring for dehydration. The doctor asked that his office be called in the morning and said that he may have R1 see a physician. CMS Ex. 14, at 3.

A nursing notes entry at 12:00 p.m. stated as follows. R1 was 'rolling back and forth in bed with head of bed up.' CMS. Ex. 14, at 3. R1 said, 'I can't get my air, can't breathe, please help me.' Id. At that time, R1 was receiving oxygen at 2L/NC. His skin color was 'pale to a grey,' his skin was warm dry, he was trying to cough up phlegm and having nausea without emesis (vomiting). The nurse sat R1 up but this did not help R1 feel that he could breathe any better. His oxygen saturation was 96% and his blood pressure was 86/42. He was incontinent of bowel and bladder. The nurse called the hospice nurse and was instructed to make R1 comfortable and continue giving oxygen at 2L/NC.

The nursing note entry at 12:15 p.m. stated that hospice was called and updated 'on the situation' and informed 'how res was this early AM, and how is he is at this time.' CMS Ex. 14, at 3. The note stated that the hospice nurse instructed the nurses to continue at the same rate of oxygen and not to send R1 to the hospital. The hospice nurse said that she would try to see R1 that afternoon.

Between the 12:15 p.m. entry and the following entry at 1:00 p.m., there is an entry that the family had been called and a message left on an answering machine 'of incident and all the care being done for resident.' CMS Ex. 14, at 4. ⁽²⁾

The nursing notes entry at 1:00 p.m. reported R1 was unable to bear weight on his legs while getting off the toilet or while being transferred to bed. He was unable to verbalize. His blood pressure was 80/40, his pulse was 40, his respiration was 32, and his oxygen saturation was 93. His skin was cool to touch and his color was white. CMS. Ex. 14, at 4. At this time, the nurses again called R1's family and left messages. A daughter from Kansas City called back and said she was on the way. Id.

The nursing notes entry at 1:30 p.m. reported as follows. The hospice nurse had been called again to report on R1's condition. The hospice nurse said she was in Wamego and would be at the facility soon. Id.

The nursing notes stated that at 2:05 p.m. R1 was dead.

V. Discussion

A. Petitioner's failure to update R1's physician as to the decline in his condition constituted a failure to provide the necessary care and services to allow him to attain or maintain the highest practicable physical, mental, and psychosocial well-being and poseda greater risk to his health and safety than the potential for causing minimal harm. The facility was therefore not in substantial compliance with program participation requirements, specifically 42 C.F.R. § 483.25 (Quality of Care).

I must determine whether Petitioner's failure to update R1's physician as to the decline in his condition constituted a failure to provide necessary care and services to allow him to attain or maintain the highest practicable physical, mental, and psychosocial well-being and whether such failure posed no greater risk to a resident's health and safety than 'the potential for causing minimal harm.' ⁽³⁾ 42 C.F.R. § 488.301. Southridge Nursing and Rehabilitation Center, DAB No. 1778 (2001).

Petitioner does not dispute that a facility is required to update a resident's physician if a resident's condition declines. ⁽⁴⁾ However, Petitioner argues that there was no failure to provide necessary care and services because R1 did not experience any 'decline in condition' which should have been reported to the doctor. Petitioner states --

[t]he primary issue with this element is the 'decline in condition', namely what constituted a 'decline' from the time of the initial contact with the physician to the point where another call to the physician was required. This resident's condition had been in a continual decline for some time, with the resident being diagnosed as terminal and provided hospice services.

P. Posthearing Br. at 10. Thus, Petitioner concludes that 'as there was no significant change in the resident's condition from the time of the initial conversation with the physician on call until the resident was found without vital signs, there was no need for additional physician notification.' Id. at 14.

I reject this argument. While it is undisputed that R1 had been suffering a continual decline from a heart condition that was expected to lead to his death, on February 4 he suffered a precipitous decline which was a 'significant change' from any continual decline identified by Petitioner. The detailed hospice assessment of R1 conducted on January 30, 2001described R1 as continent of bladder and bowel (P. Ex. 2, at 2, 4, and 5), as 'alert and answer[ing] all questions appropriately' (Id. at 5), and as having limited mobility (Id.). There is nothing in the nursing notes to show that R1's condition fundamentally changed between January 30 and the morning of February 4. ⁽⁵⁾ However, over the course of the morning and early afternoon of February 4, 2001, R1 experienced the following significant changes.

At 8:30 that morning, R1 told a nurse he had fallen out of bed during the night and hit his head. The nurse found no sign of injury, R1 was able bear his weight with one standby assist during a transfer but was incontinent of bladder. CMS Ex. 14, at 2.

By 10:15 that morning, R1 continued not to feel well and he 'seemed confused,' he was able to transfer 'with difficulty,' his blood pressure was 88/46, his pulse was 64, his respiration 26, his temperature 96.9 orally, his saturated oxygen 95%. Id., at 3.

At 12:00 p.m., R1 was 'rolling back and forth in bed with head of bed up' saying 'I can't get my air, can't breathe, please help me.' Id., at 3. His skin color was 'pale to a grey,' his skin was warm and dry, he was trying to cough up phlegm and having nausea. Id. The nurse sat R1 up but this did not help R1 feel like he could breathe any better. His blood pressure was 86/42. He was incontinent of both bowel and bladder.

At 1:00 p.m., R1 was unable to bear weight on his legs while getting off the toilet or while being transferred to bed. He was unable to verbalize. His blood pressure was 80/40, his pulse was 40, his respiration was 32, and his oxygen saturation was 93. His skin was cool to touch and his color was white. Id., at 4. ⁽⁶⁾

By 2:05 p.m., R1 was dead.

Thus, between 9:30 that morning and 1:00 that afternoon, R1 became confused, became so unable to breathe that he thrashed about and begged the nurses for help, became incontinent of bowel, became nauseated, became unable to bear weight on his legs, became unable to verbalize, lost color in his skin and became cool to touch, and experienced a drop in his blood pressure from 88/46 to 80/40 and his pulse from 60 to 40. None of this was reported to his doctor. Additionally, by 8:30 a.m., R1 had become incontinent of bladder and had reported he had fallen in the previous night and hit his head, but neither of these facts was reported to the doctor in the 9:30 a.m. call or subsequently.

Did this decline in this condition constitute a change that warranted further notification of R1's physician after the nurse's first conversation with the doctor at 9:30 a.m.? Based on the following evidence, I conclude that it did. Three surveyors testified that the doctor should have been recontacted. Tr. at 40 - 41, 55 - 57, 80 - 82, 95, 101 - 102, 111, 134 - 135, and 141. Two of the surveyors were registered nurses and the third was a physician licensed in India. Additionally, on February 8, 2001, one surveyor talked with Dr. Patel, the physician on call for R1 on February 4. She testified that Dr. Patel told her that he would have wanted the nurses to tell him that R1's condition was deteriorating. Tr. at 34. Further, the surveyor's summary of her notes from that interview stated that, from his 9:30 a.m. conversation with the nurse, Dr. Patel said that he understood R1's condition to be stable. He said that had he known R1 was deteriorating, he would have 'contacted the family and given fluids or some type of intervention. He stated that they should have communicated that he was declining . . . . He stated a change in condition should be communicated to the physician.' CMS Ex. 5, at 8. ⁽⁷⁾ The surveyor's testimony corroborated her notes. Tr. at 27 - 29, 34.

At the hearing, Petitioner called three doctors to testify on its behalf. For the following reasons, this testimony does not cause me to alter my conclusion that Petitioner should have recontacted Dr. Patel about R1's decline.

Dr. James Rider testified as follows:

Q. Okay. From the assessments that were performed and what was noted in the record, could you see any need to notify the physician again?

A. No. I think the physician really wasn't too interested in being notified again and just gave order for them to watch him and - only if there was a major change, which other than his death there really wasn't.

Q. Uh - huh.

A. There wasn't a big need to call him again. They did talk to the Hospice nurse twice.

Tr. at 149.

On cross examination, Dr. Rider testified as follows:

Q. You mentioned during your testimony that you commended the medical staff at Rolling Hills because nothing was left out that would have helped. Yet I'm at a loss to justify that statement in recognition that the physician in this case, Dr. Patel, didn't seem to be fully notified. Can you help me out here, please?

A. Well, I though he was notified and called and told the vital signs and his response was to do some more vital signs. So that means that he didn't think there was much else to be done for the patient.

Q. Is it your assessment that he merely wanted to - thought the patient was going to die and just wanted to have the person monitored and kept comfortable?

A. I think he was probably aware of the Hospice situation and that the patient comfort measures was the main goal, and that's why he gave the orders he gave.

Tr. at 155.

I do not find Dr. Rider's testimony persuasive because his conclusion is based on an assumption that is not supported by the evidence. Dr. Rider assumed that Dr. Patel knew R1 was in the process of dying on February 4 and, therefore, did not need to be called again. Nothing in the nurse's description of her call to Dr. Patel indicated that she told the doctor that R1 was experiencing a change in condition that would cause the doctor to believe he was dying that day. CMS Ex. 6. Further, Dr. Patel told the surveyor that he understood from the nurse that R1 was stable, that he did not know R1 was deteriorating, and that, had he understood R1 was deteriorating, he would have contacted R1's family about intervention. CMS. Ex. 5, at 8. Since Dr. Rider incorrectly assumed that as of 9:30 a.m. Dr. Patel understood R1 to be dying, Dr. Rider's opinion that Petitioner's staff should not have called Dr. Patel after 9:30 is not persuasive.

Dr. Bradley Marples testified as follows:

Q. Okay. There was a concern cited in the deficiency that the physician should have been notified again upon the resident's decline. Do you recall that?

A. Yes.

Q. Okay. Did you see anything within the record that would in your experience make you feel a physician needed to be notified again?

A. It certainly wasn't something that I felt was lacking that the doctor could have been called again or anything different would have been told to the doctor than what was told.

Tr. at 178.

I reject this testimony as neither fully informed nor credible. The record before me indicates that Dr. Patel was told of the medication error and R1's blood pressure. He believed R1 was stable and instructed the nurses to continue to monitor him. CMS Ex. 5, at 8. Perhaps Dr. Marples was not informed of this evidence. Thus, the 'anything different' that 'would have been told to the doctor' should include the many symptoms that indicated that R1 was not stable, i.e., the facts that R1 became incontinent of bladder, became confused, became so short of breath that he begged the nurses for help, became incontinent of bowel, became nauseated, became unable to bear weight on his legs, became unable to verbalize, lost color in his skin and became cool to touch, and had his blood pressure drop from 88/46 to 80/40 and his pulse from 60 to 40.

Dr. Vijay Mhatre, Petitioner's medical director and R1's treating physician, testified on behalf of Petitioner. On direct, counsel for Petitioner asked him about R1's not being assessed by a registered nurse (Tr. at 202 - 203) and the quality of the assessments that were done for R1 on February 4 (Tr. at 203 - 204). Counsel did not ask on direct whether Dr. Patel, who works in Dr. Mhatre's office (Tr. at 205), should have been contacted after the first call and prior to R1's death. On cross examination, counsel for CMS did not ask Dr. Mhatre about Petitioner's failure to recontact Dr. Patel. Therefore, Dr. Mhatre offered no expert opinion on this question.

In addition to concluding that 42 C.F.R. § 483.25 requires Petitioner to have called R1's doctor after the first call and before his death, I conclude that Petitioner's failure to do so posed a greater risk to R1's health and safety than 'the potential for causing minimal harm' (42 C.F.R. § 488.301) and therefore constituted substantial noncompliance. Petitioner's failure to call Dr. Patel meant that there was no opportunity for a medical assessment by a doctor, in conjunction with the family, of whether something could or should have been done to prevent R1 from dying and no opportunity for a medical assessment of whether there was palliative care that could have made R1's death less difficult for him. Lack of such assessments obviously posed a risk of causing more than minimal harm to R1 and other similarly situated patients.

The parties devoted considerable attention to R1's blood pressure (CMS contending that R1's low blood pressure on the morning of February 4 could have resulted from the medication error) and to whether R1's death was related to the medication error. However, it is not necessary for CMS to establish that Petitioner's medication error or failure to call Dr. Patel actually harmed R1. See Lake City Extended Care Center, DAB No. 1658 (1998). A facility is subject to enforcement action when there is evidence that it was not in 'substantial compliance' with participation requirements. 42 C.F.R. § 488.330(b), 488.430. A facility is not in substantial compliance if its acts or omissions either cause actual harm or create the potential for causing more than minimal harm. 42 C.F.R. § 488.301, 488.408. Therefore, as to the deficiency at issue, it is irrelevant whether R1 was dying from his heart condition, from a head injury suffered in the fall the nurses never reported to the doctor, from a stroke (as suggested by Dr. Mhatre at Tr. at 211), from the medication error, or from some combination of these factors. It is also irrelevant whether Dr. Patel, after consultation with the family, would have ordered medical intervention. The point is that Petitioner's failure to update the doctor prevented the doctor from making a medical assessment as to what could or should have been done for R1, created the potential for causing more than minimal harm, and constituted a failure to provide the necessary care and services to allow R1 to attain or maintain the highest practicable physical, mental, and psychosocial well-being.

B. Petitioner did not prove to be clearly erroneous CMS's determination that Petitioner's noncompliance with 42 C.F.R. § 483.25, on February 4, 2001, posed immediate jeopardy to the health and safety of its residents.

CMS determined that Petitioner's noncompliance with 42 C.F.R. § 483.25 placed residents of Petitioner's facility at immediate jeopardy. I sustain this determination.

'Immediate jeopardy' is defined to mean:

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

42 C.F.R. § 488.301.

CMS has a burden of showing, prima facie, that its determination that the deficiency met this definition is correct. See Hillman Rehabilitation Center, DAB No. 1611 (1997). If it does so, then Petitioner must prove CMS's determination to be clearly erroneous. 42 C.F.R. § 498.60(c)(2). CMS is not required to show that the noncompliance actually caused serious injury, harm, impairment, or death, but only that the noncompliance was 'likely to cause' such consequences. Hermina Traeye Memorial Nursing Home, DAB No. 1810 (2002); Southridge Nursing and Rehabilitation Center, DAB No. 1778 (2001).

CMS satisfied its burden in this case. There is prima facie evidence showing that Petitioner's failure to contact R1's doctor about R1's decline meant that there was no medical assessment by a doctor of whether something could or should have been done to prevent R1 from dying on February 4, 2001 and no medical assessment of whether there was palliative care that could have made R1's death that day less difficult for him. Dr. Patel indicated that had he known of R1's decline, he would have discussed medical alternatives with the family. CMS Ex. 5, at 8. Even Dr. Marples, who testified for Petitioner, said that he would have 'talked about some kind of morphine or something like that to relieve air hunger, make him more comfortable.' Tr. at 181. Plainly, failure to notify a doctor while a resident suffers the decline R1 suffered on February 4 is likely to result in failure to provide appropriate treatment or care to prevent harm or death. This constitutes immediate jeopardy.

The fact that R1 was expected to die within the next six months of his heart disease and had been enrolled in hospice care does not change my assessment. As both parties' witnesses agreed, the fact that a patient or resident is under hospice care does not mean that the patient or resident need not receive appropriate medical care or that the resident or patient's doctor need not be consulted about what that care should be. See Tr. at 137, 150 - 151, 171 - 172, 179 - 180.

Aside from arguing that there was no deficiency under § 483.25, Petitioner offered no arguments as to the relationship between the evidence in the record and the standards for determining immediate jeopardy. I conclude that Petitioner did not offer any proof establishing that CMS's determination of immediate jeopardy was clearly erroneous.

C. The amount of the CMP imposed against Petitioner, $7,000, is reasonable.

Having found a basis for imposing a CMP, I now consider whether that amount is reasonable, applying the factors listed in 42 C.F.R. §§ 488.438(f) and 488.404. Emerald Oaks, DAB No. 1800, at 10 (2001); CarePlex of Silver Spring, DAB No. 1683, at 16 - 17 (1999); Capitol Hill Community Rehabilitation and Specialty Care Center, DAB No. 1629 (1997). CMS is not required to offer evidence as to the § 488.438(f) factors as part of its prima facie case. The facility must timely raise its claim that a particular factor makes a CMP unreasonable before any question arises as to CMS's responsibility for producing evidence as to that factor. Community Nursing Home, DAB No. 1807, at 22 (2002). When penalties are imposed for an instance of noncompliance, the penalties may range between $1,000 to $10,000 per instance. 42 C.F.R. § 488.438.

Petitioner stated in its Report of Petitioner's Readiness to Present Evidence for Adjudication of the Case dated March 15, 2002, that the question of whether a per instance CMP of $7,000 was reasonable was at issue. However, Petitioner indicated in posthearing briefing that it had 'waived the issue of whether the imposition of the civil money penalty was reasonable' (Reply to Post-Hearing Br. at 3) and produced no evidence at the hearing or arguments in its briefings concerning the factors listed at § 488.438(f) of 42 C.F.R. or the reasonableness of the CMP.

Moreover, I find the penalty amount of $7,000 to be reasonable based on evidence which relates to factors that are relevant to deciding the penalty amount. Those factors include the seriousness of the deficiencies.

Petitioner's staff's action deprived a very sick elderly man of the potential benefit of medical intervention to prevent his death or of medical intervention to comfort and ease that death. Because this deficiency was very serious and the penalty is not far above the midpoint of the per instance penalty range, I am unable to find the imposition of a $7,000 unreasonable.

VI. Conclusion

For the reasons discussed above, I uphold CMS's determination that the facility was not in substantial compliance with the quality of care requirement set forth at 42 C.F.R. § 483.25, that the noncompliance posed immediate jeopardy to resident health and safety, and that the $7,000 per instance CMP is reasonable.

Richard J. Smith

Administrative Law Judge

1. The initial Statement of Deficiencies issued after the survey conducted February 13, 2003 identified three deficiencies: 42 C.F.R. § 483.13(c)(1)(i)(staff treatment of residents); § 483.25 (quality of care); and § 483.25(m)(1)(significant medication error). As a result of an informal dispute resolution proceeding conducted by the State agency, the first and third deficiency citations were dropped. Therefore, at issue before me is Petitioner's compliance with 42 C.F.R. § 483.25.

2. The interview notes with R1's daughter state that she received a call on her message machine at 10:11 a.m. telling her about R1's fall and a message shortly thereafter telling her that R1 had been given an antihypertensive medicine in error. At 1:00 p.m. there was a message saying R1 'had taken a drastic turn for the worse.' CMS Ex. 5, at 9. Upon returning home, she called the facility at 1:30 and she stated she was told that R1 had become 'totally unresponsive.' Id.

3. The Statement of Deficiencies stated that Petitioner was not in substantial compliance with § 483.25 because of three alleged failures: (1) the failure to provide R1 'with a thorough on-going assessment when there was a change in condition,' (2) the failure 'to ensure that [R1] was assessed by a registered nurse,' and (3) the failure 'to ensure that the physician was updated on [R1's] decline in condition.' CMS Ex. 4, at 18. All of these grounds were addressed in the briefing and at the hearing. Because I find that Petitioner's failure to update the physician of R1's decline constitutes substantial noncompliance, I do not address the other two alleged failures.

4. Section § 483.10(b)(11)(i) of 42 C.F.R. provides that the facility must:

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

. . .

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

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

The state agency did not cite Petitioner under this regulation because Petitioner's nurses had initially notified the physician. Tr. at 51. Whether or not this regulation could have been applied to the circumstances here, the regulation is instructive as to when a facility should consult with the physician. Further, as explained in the decision, the decline in R1's physical and mental status constituted a 'significant change' as that term is used in this regulation.

5. The record does contain an after-the-fact statement by an employee saying that R1 needed more help than usual on Saturday, February 3, was unusually exhausted and complained of shortness of breath frequently. CMS Ex. 7. However, in her interview with the surveyors, his daughter reported that she had had lunch with him and he 'wasn't acting any differently.' CMS Ex. 5, at 9. The nursing notes on February 3 reflect that R1 didn't feel well but was continent of bowel and bladder and could still accomplish transfers with assistance. CMS Ex. 14, at 2.

6. R1's daughter told a surveyor that the message from the nurse which was left on her answering machine at 1:00 said that R1 had taken a 'drastic turn for the worse.' CMS Ex. 5, at 9. The daughter also said that when she talked with the nurse at 1:30 p.m., the nurse said R1 was 'totally unresponsive.' Id. The hospice nurse's notes indicate that in the call to her at 1:10 p.m. the nurse said R1 'was declining rapidly.' CMS Ex. 11, at 1.

7. Petitioner complains that, based on the surveyors' testimony, 'it is impossible to tell how much additional contact with the physician would have been required in order to satisfy the survey team.' P. Posthearing Br. at 13. It concludes that '[t]he standard being cited in this deficiency does not appear to come from any 'standard of practice' in the medical community, but rather from the individual beliefs or ideals of each surveyor, making compliance with this deficiency impossible.' Id. at 14. Had Petitioner actually recontacted Dr. Patel and been cited with a deficiency, I would have to address this argument. However, given that Petitioner failed completely to notify Dr. Patel about R1's decline, it is not necessary to determine what notification would have constituted substantial compliance with the regulation.