SUBJECT:

IHS of Kansas Ciry at Alpine North,

Petitioner,

Centers for Medicare & Medicaid Services.

DECISION

IHS of Kansas City at Alpine North (Petitioner) violated 42 C.F.R. � 483.25 ⁽¹⁾ (Tag F 309) with regard to one resident as determined by a survey of the facility completed on April 18, 2002. There is a basis for the imposition of a per instance civil money penalty (CMP) of $10,000, and that CMP is not unreasonable.

I. Background

Petitioner is a long-term care facility participating in the federal Medicare program as a skilled nursing facility (SNF) and in the Missouri Medicaid program as a nursing facility (NF). Petitioner is located in Kansas City, Missouri. The Missouri Department of Health and Senior Services (the state agency) conducted an abbreviated survey that was completed on April 18, 2002 at Petitioner's facility and prepared a statement of deficiencies (SOD). The survey team determined that Petitioner was not in substantial compliance with 42 C.F.R. � 483.25 (Tag F 309) at the immediate jeopardy level. ⁽²⁾

Petitioner was notified by letter from CMS dated June 17, 2002 that, based on the survey which ended on April 18, 2002, CMS was imposing a denial of payment for new Medicare and Medicaid admissions (DPNA) effective July 2, 2002 and a per instance CMP of $10,000. By letter dated July 17, 2002, CMS advised Petitioner that a revisit survey, conducted on June 21, 2002, established that Petitioner was in substantial compliance and, accordingly, the DPNA would not be imposed.

Petitioner requested a hearing on August 16, 2002. The case was assigned to me for hearing and decision on September 5, 2002. I conducted a hearing in this case on April 22 and 23, 2003, in Kansas City, Missouri. A 337-page transcript (Tr.) was prepared and reviewed by the parties. During the hearing, CMS offered and I admitted into evidence CMS Exhibits (Exs.) 1 ⁽³⁾ through 10. Tr. 40-50, 53, 56, 58, 62-64, 66, 70, 328. Petitioner offered and I admitted into evidence Petitioner's Exhibits (P. Exs.) 1 through 18. Tr. 87-90, 276. CMS did not call any witnesses, choosing to rely upon the documentary evidence. Tr. 101. Petitioner called three witnesses: Shelia Harris Williams, a Registered Nurse and Petitioner's Director of Nursing; Charlotte Bruyn, a social worker employed as Director of Social Services at the facility; and Lisa Myers, a registered nurse and Senior Corporate Clinical Services Director for Petitioner's parent company. Petitioner also called Lisa McGhee, who was the state agency surveyor who conducted the survey of the facility, for cross-examination. ⁽⁴⁾ The parties were directed to file post hearing briefs and reply briefs. All post hearing briefs were timely filed.

II. Findings of Fact and Conclusions of Law

A. Findings of Fact

1. Petitioner's facility, IHS of Kansas City at Alpine North, is a 186-bed skilled nursing facility located in Kansas City, Missouri that is certified to participate in the federal Medicare program and the Missouri Medicaid program.

2. The state agency conducted an abbreviated survey of Petitioner's facility that was completed on April 18, 2002.

3. At the conclusion of the survey, the state agency prepared a SOD. CMS Ex. 4.

4. The state agency alleged that Petitioner violated 42 C.F.R. � 483.25 (Tag F 309) with respect to Resident 25 and that the violation was at the immediate jeopardy level, as defined at 42 C.F.R. � 488.301.

5. On June 21, 2002, the state agency conducted a revisit survey and determined that corrections had been made and that Petitioner was in substantial compliance.

6. On June 17, 2002, CMS notified Petitioner of the alleged violation and that CMS intended to impose a per instance CMP of $10,000.

7. Resident 25 was a 98-year-old female who was admitted to Petitioner's facility on April 28, 2001, following hospitalization at the University of Kansas Hospital for an acute cerebro-vascular accident (CVA) or stroke. CMS Ex. 6, at 3, 11.

8. On Petitioner's Diet/Nourishment Consumption Record (consumption record) for the month of January 2002 for Resident 25, there are 10 days for which staff left blank the space for at least one meal or snack. There are no days on which staff recorded that Resident 25 refused a meal or snack. CMS Ex. 6, at 6.

9. On February 5, 2002, the consumption records indicate that Resident 25 refused breakfast, lunch, and PM snack, but consumed 80% of her dinner. CMS Ex. 6, at 7.

10. On February 6, 2002, the consumption records indicate that Resident 25 refused lunch and PM snack. The spaces for breakfast and dinner are left blank. CMS Ex. 6, at 7.

11. On February 7, 2002, the consumption records indicate that Resident 25 refused breakfast and consumed 25% of her lunch. The space for dinner is left blank. CMS Ex. 6, at 7.

12. On February 8, 2002, the facility's records indicate that Resident 25 consumed "0" for breakfast and AM snack, and 20% of her lunch. The space for dinner is left blank. CMS Ex. 6, at 7.

13. Resident 25's consumption records for February 5 through 8, 2002, document a change in her eating patterns from the previous month.

14. It is unrebutted that a certified nursing assistant (CNA) who cared for Resident 25 during the period February 2 through 4, 2002, when interviewed by the surveyor in April 2002, recalled that the resident ate poorly, that her perineal area was red, and that her urine was very concentrated and odorous. The CNA believed these to be signs of possible urinary tract infection (UTI), knew she was to report such signs, but could not recall to whom she reported. CMS Ex. 5, at 16.

15. Another CNA who cared for Resident 25 on February 5 and 6, 2002, when interviewed by the surveyor in April 2002, recalled that the resident's perineal area was red and that her urine was stronger than usual. She could not recall to whom she reported these signs. CMS Ex. 5, at 19.

16. On the facility form entitled "C.N.A. DAILY SKIN INSPECTION" for the month of January 2002, the CNAs caring for Resident 25 checked the blocks indicating that the resident's skin was clear for every day of the month. CMS Ex. 6, at 94.

17. On the facility form entitled "C.N.A. DAILY SKIN INSPECTION" for the month of February 2002, the CNAs caring for Resident 25 checked blocks indicating skin redness for February 1 through 4 and 7 and 8. The diagram on the form indicates that the redness was in the area of the resident's perineum and buttocks. There are no entries on the form for February 5 or 6. CMS Ex. 6, at 4.

18. The Daily Skin Inspection Form for February 2002 is consistent with the statements of the CNAs to the surveyor that they had observed Resident 25 to have reddened skin in the perineal area.

19. Other than the Daily Skin Inspection Form, which instructs the CNA to report any change in skin condition to the nurse immediately, there is no documentation in the record that the observations of the CNAs, that Resident 25's perineal area was red and that her urine was concentrated and/or foul smelling, were communicated to Petitioner's nursing staff.

20. On February 2, 2002, Resident 25 was noted to have a temperature of 97.7. CMS Ex. 6, at 17.

21. On February 6, 2002, Resident 25 was noted to have a temperature of 101. Petitioner's staff gave the Resident Tylenol; thereafter (still on February 6) the Resident's temperature was recorded at 99.4 and then 99.0. CMS Ex. 6, at 17, 19.

22. The nurse caring for Resident 25 on February 6, 2002, noted wheezing, but no cough, congestion, or nasal drainage. CMS Ex. 6, at 17.

23. The nurse documented that she notified the resident's physician on February 6, 2002, and she was instructed to monitor Resident 25's condition. CMS Ex. 6, at 17.

24. On February 7, 2002, the Resident's temperature was noted to be "98.9 AX [axillary]." CMS Ex. 6, at 19.

25. On February 8, 2002, Resident 25 had a seizure-like episode and thereafter was unresponsive. She was transferred by ambulance to North Kansas City Hospital. CMS Ex. 6, at 19, 62.

26. Records from North Kansas City Hospital show that Resident 25 was admitted on February 8, 2002, with a temperature of 99.3 and she was unresponsive except that she opened her eyes to touch, and the initial assessments were mental status changes and seizures of unclear etiology but possible CVA or metabolic component; controlled hypertension; acute renal failure; UTI; questionable aspiration pneumonia; hypernatremia and hyperphosphatemia. P. Ex. 9, at 6-8.

27. Consultative examinations on February 9, 2002, resulted in assessments of renal insufficiency, mental status changes, hypertension, and UTI (P. Ex. 9, at 1-3) and generalized seizure disorder possibly due to multiple metabolic abnormalities or left occipital CVA, renal insufficiency, UTI, and possible myocardial infarction (P. Ex. 9, at 4-5).

28. Resident 25 died at North Kansas City Hospital on February 16, 2002. CMS Ex. 7, at 62.

29. The hospital death summary reflects that Resident 25 was admitted to the hospital with: change in mental status and seizures of unknown etiology; hypertension; acute renal failure; urinary tract infection; questionable aspiration pneumonia; and hypernatremia. Upon her death, her diagnoses were: renal failure; urosepsis; probable myocardial infarction; seizure disorder probably secondary to metabolic disturbances; dementia with a history of CVA; and hypertension. CMS Ex. 7, at 62.

B. Conclusions of Law

1. Petitioner timely requested a hearing and I have jurisdiction.

2. Pursuant to 42 C.F.R. � 483.25, each resident of a facility, such as Petitioner's, must receive and the facility must provide the necessary care and services 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.

3. CMS made a prima facie showing that Petitioner failed to provide the necessary health care and services to Resident 25 based upon Petitioner's failure to investigate adequately the cause of Resident 25's change in eating patterns and elevated temperature on or after February 5, 2002, and to take action to provide necessary care and services.

4. The CMS determination that there was immediate jeopardy with respect to the violation of 42 C.F.R. � 483.25 (Tag F 309) was not clearly erroneous but such determination does not affect the amount of the CMP imposable in this case except to the extent that such determination reflects that violation was considered serious by CMS.

5. A per instance CMP in the amount of $10,000 is not unreasonable.

III. Discussion

A. Issues

The issues in this case are:

Whether Petitioner was in substantial compliance with the requirements of participation set forth in 42 C.F.R. � 483.25, Tag F 309; and

Whether the CMP imposed by CMS was reasonable.

B. Applicable Law

The Social Security Act (Act) sets forth requirements for long-term care facility (SNF and NF) participation in the Medicare and Medicaid programs, and authorizes the Secretary of Health and Human Services (Secretary) to promulgate regulations implementing the statutory provisions. Act �� 1819 and 1919. The Secretary's regulations governing nursing facility participation in the Medicare program are found at 42 C.F.R. Part 483. Regulations governing survey, certification, and enforcement procedures, and regulations governing provider agreements, are found at Parts 488 and 489, respectively. Regulations governing appeals procedures are found at Part 498.

To participate in the Medicare and Medicaid programs, facilities periodically undergo surveys to determine whether they comply with applicable statutory and regulatory requirements for Medicare (SNFs) and/or Medicaid (NFs). They must maintain substantial compliance with program requirements, and, to be in substantial compliance, a facility's deficiencies may pose no greater risk to resident health and safety than "the potential for causing minimal harm." 42 C.F.R. � 488.301.

Under the statute and "quality of care" regulation, each resident must receive and the facility must provide the necessary care and services 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 � 1819(b); 42 C.F.R. � 483.25.

If a facility is not in substantial compliance with program requirements, CMS has the authority to impose, in addition to termination, one or more of the enforcement remedies listed in 42 C.F.R. � 488.406, including a DPNA, directed in-service training, and imposition of a CMP. See Act � 1819(h). CMS may impose a CMP for the number of days that the facility is not in substantial compliance with one or more program requirements or for each instance that the facility is not in substantial compliance. 42 C.F.R. � 488.430(a). In situations where the deficiencies do not constitute immediate jeopardy, but have caused actual harm or have the potential for more than minimal harm, CMS may impose a CMP in the lower range of $50 to $3,000 per day. Penalties in the range of $3,050 to $10,000 per day are imposed for deficiencies constituting immediate jeopardy. 42 C.F.R. � 488.438. The regulations also authorize CMS to impose a CMP for an instance of noncompliance with a single range of $1,000 to $10,000 per instance that is not affected by the existence of immediate jeopardy. 42 C.F.R. �� 488.408, 488.438.

In setting the amount of the CMP, CMS considers: 1) the facility's history of noncompliance; 2) the facility's financial condition; 3) 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 factors in section 488.404 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.

The Act and regulations make a hearing before an ALJ available to a long-term care facility against which CMS has determined to impose a CMP. Act, section 1128A(c)(2); 42 C.F.R. �� 488.408(g), 498.3(b)(13). The hearing before an ALJ is a de novo proceeding. Anesthesiologists Affiliated, et al, DAB CR65 (1990), aff'd, 941 F.2d 678 (8^th Cir. 1991). A facility has a right to appeal a "certification of noncompliance leading to an enforcement remedy." 42 C.F.R. � 488.408(g)(1); see also 42 C.F.R. �� 488.330(e) and 498.3. However, the choice of remedies by CMS or the factors CMS considered when choosing remedies are not subject to review. 42 C.F.R. � 488.408(g)(2). A facility may only challenge the scope and severity level of noncompliance found by CMS if a successful challenge would affect the amount of the CMP that could be collected by CMS or impact upon the facility's nurse aide training program. 42 C.F.R. �� 498.3(b)(14) and (d)(10)(I). CMS's determination as to the level of noncompliance "must be upheld unless it is clearly erroneous." 42 C.F.R. � 498.60(c)(2). This includes CMS's finding of immediate jeopardy. Woodstock Care Center, DAB No. 1726, at 9, 38 (2000), aff'd, Woodstock Care Center v. Thompson, 363 F.3d 583 (6^th Cir. 2003). The Departmental Appeals Board (the Board) has long held that the net effect of the regulations is that a provider has no right to challenge the scope and severity level assigned to a noncompliance finding, except in the situation where that finding was the basis for an immediate jeopardy determination. See, e.g., Koester Pavilion, DAB No. 1750, at 8 (2000). Review of a CMP by an ALJ is governed by 42 C.F.R. � 488.438(e).

When a remedy is imposed and appealed, CMS must make a prima facie showing that the facility has failed to comply substantially with federal participation requirements. "Prima facie" means that the evidence is "(s)ufficient to establish a fact or raise a presumption unless disproved or rebutted." Black's Law Dictionary 1228 (8^th ed. 2004). To prevail, a long-term care facility must overcome CMS's showing by a preponderance of the evidence. Batavia Nursing and Convalescent Inn, DAB No. 1911 (2004); Batavia Nursing and Convalescent Center, DAB No. 1904 (2004); Emerald Oaks, DAB No. 1800 (2001); Cross Creek Health Care Center, DAB No. 1665 (1998); Hillman Rehabilitation Center, DAB No. 1611 (1997), aff'd Hillman Rehabilitation Center v. U.S. Dept. of Health and Human Services, No. 98-3789 (D.N.J. May 13, 1999). A preponderance of evidence is "superior evidentiary weight that, though not sufficient to free the mind wholly from all reasonable doubt, is still sufficient to incline a fair and impartial mind to one side of the issue rather than the other." Black's Law Dictionary (7th ed. 1999) (cited by the Departmental Appeals Board (Board) in Beechwood Sanitarium, DAB No. 1906, at 38 (2004)).

C. Analysis

1. CMS made a prima facie showing that Petitioner was out of compliance with 42 C.F.R. � 483.25 (Tag F 309).

Petitioner argues that CMS failed to make a prima facie case that the facility was out of compliance with 42 C.F.R. � 483.25 (Tag F 309). CMS bears the initial burden of producing evidence sufficient to establish a prima facie case for each alleged violation of the regulations. The DAB defined the requirements for a prima facie case in the Hillman decision:

HCFA ⁽⁵⁾ must identify the legal criteria to which it seeks to hold a provider. Moreover, to the extent that a provider challenges HCFA's findings, HCFA must come forward with evidence of the basis for its determination, including the factual findings on which HCFA is relying and, if HCFA has determined that a condition of participation was not met, HCFA's evaluation that the deficiencies found meet the regulatory standard for a condition-level deficiency.

DAB No. 1611, at 11. If a provider appeals an enforcement decision, CMS has the initial burden of showing that its decision to terminate is legally sufficient under the statute and regulations. To make a prima facie case that its decision was legally sufficient in this case, CMS must: (1) identify the statute, regulation or other legal criteria to which it seeks to hold the provider; (2) come forward with evidence upon which it relies for its factual conclusions that are disputed by the Petitioner; and (3) show how the deficiencies it found amount to noncompliance that warrants an enforcement remedy.

Petitioner recognizes that CMS meets its initial burden if it offers evidence that, if credible and unrebutted, would constitute proof that the facility was not in substantial compliance. Petitioner's Post-Hearing Brief (P. Br.) at 4. It is not incumbent upon CMS when presenting its prima facie case to eliminate every possible alternative inference that might be drawn from the evidence. Instead, it is sufficient if CMS can point to evidence from which one of the inferences that might reasonably be drawn is that Petitioner failed to comply with a regulatory requirement. CMS's burden is not high and, in some instances, CMS may meet this burden by offering in evidence the SOD alone. In the present case, CMS has offered additional evidence beyond the SOD, including Petitioner's own records and those of treating physicians, and the evidence taken as a whole must be considered when determining whether CMS has made a prima facie showing of a regulatory violation.

In addition to the SOD, CMS relies on the statement of Lisa McGhee, R.N., a surveyor employed by the state agency, to establish its prima facie case. ⁽⁶⁾ Ms. McGhee conducted the investigation and formulated the findings in the SOD. CMS Ex. 1, at 106. The SOD identifies the regulation with which Petitioner allegedly failed to comply - 42 C.F.R. � 483.25 (Tag F 309). The SOD and Ms. McGhee's statement both identify facts which CMS contends support its conclusion that Petitioner was noncompliant. These facts include:

�Resident 25's eating patterns changed in early February;

�Two CNA's who cared for Resident 25 reported that, in early February, she had reddened skin in the perineal area and foul-smelling urine;

�Resident 25 had an elevated temperature beginning on February 6, 2002;

�On February 6, 2002, Petitioner gave Resident 25 Tylenol for the elevated temperature and notified her physician who instructed that she be monitored; and

�Petitioner's records do not document any further investigation of the cause of Resident 25's signs and symptoms prior to her hospitalization on February 8, 2002.

It is CMS's position that Petitioner failed to address adequately the signs and symptoms exhibited by Resident 25. In CMS's view, the resident's symptoms were sufficient to put Petitioner on notice that she might have a urinary tract infection or other threatening condition. CMS concludes that Petitioner's failure to investigate further the cause of Resident 25's symptoms constituted substantial noncompliance to provide Resident 25 necessary care and services. The CMS findings and conclusions are supported by credible evidence listed in my findings of fact. No more is required of CMS to present a prima facie case, and the evidence presented by CMS is sufficient. The issue then is whether Petitioner successfully has rebutted the CMS case or established an affirmative defense.

Petitioner takes issue with many of the facts on which CMS bases its conclusion that the facility was out of substantial compliance. In Petitioner's view, the evidence on which CMS relied when it concluded that Resident 25 demonstrated a change in eating habits prior to her hospitalization on February 8, is subject to other interpretations. P. Br. at 8. Similarly, Petitioner argues that the evidence that Resident 25 had reddened skin in the perineal area and/or foul-smelling urine is unreliable. Id. at 5-7. These are arguments that I must weigh in determining whether the preponderance of the evidence supports CMS's interpretation of the facts or that of Petitioner. These arguments do not detract from my conclusion that CMS has made a prima facie case.

2. Petitioner failed to prove by a preponderance of the evidence that it was in substantial compliance with 42 C.F.R. � 483.25 (Tag F-309).

Once I have concluded that CMS has made a prima facie case that Petitioner violated 42 C.F.R. � 483.25, the burden is upon the facility to prove that it was in compliance with program participation requirements. In order for Petitioner to prevail, it must 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. Emerald Oaks, DAB No. 1800; Cross Creek Health Care Center, DAB No. 1665 (1998); Hillman, DAB No. 1611.

Records from North Kansas City Hospital show that Resident 25 was admitted on transfer from Petitioner's facility on February 8, 2002, with a temperature of 99.3 and she was unresponsive except that she opened her eyes to touch, and the initial assessments were mental status changes and seizures of unclear etiology but possible CVA or metabolic component; controlled hypertension; acute renal failure; UTI; questionable aspiration pneumonia; hypernatremia and hyperphosphatemia. P. Ex. 9, at 6-8. Consultative renal and neurological examinations of Resident 25 on February 9, 2002, resulted in assessments of renal insufficiency, mental status changes, hypertension, and UTI (P. Ex. 9, at 1-3) and generalized seizure disorder possibly due to multiple metabolic abnormalities or left occipital CVA, renal insufficiency, UTI, and possible myocardial infarction (P. Ex. 9, at 4-5). CMS points to this evidence to support its position that Resident 25, in the days leading to her hospitalization, manifested signs and symptoms that Petitioner should have recognized as indicative of a potentially severe and life threatening illness in the frail resident. CMS does not need such evidence to make a prima facie showing that Petitioner failed to provide necessary care and services in violation of 42 C.F.R. � 483.25. However, the evidence from treating physicians that indicate the presence of a UTI, dehydration, metabolic imbalance and other significant conditions lends great credibility to the CMS position that the Resident displayed signs of illness while in Petitioner's custody and care, signs that Petitioner failed to recognize and treat.

Petitioner is correct that the issue here is not whether Resident 25 had certain diagnoses upon her admission to North Kansas City Hospital, but rather the question is whether Petitioner failed to recognize and address signs and symptoms of Resident 25. P. Br. at 16. However, Resident 25's diagnoses by treating physicians within hours of her admission on transfer from Petitioner's facility are material, particularly to the extent they reflect the severity of the Resident's condition upon her transfer. The significance of that evidence is reflected by Petitioner's unsuccessful efforts to discredit the diagnoses reflected in the hospital records from the early hours of Resident 25's admission. If the North Kansas City hospital records did not reflect diagnoses including UTI and dehydration, Petitioner would have strongly argued that the signs CMS points to including the fever, loss of appetite, red perineal area, and foul smelling urine were unrelated signs without any specific diagnosis. In this case, however, the diagnoses upon Resident 25's admission to the hospital give meaning to the signs and symptoms.

There is some dispute about whether or not Petitioner should have been alert to the fact that Resident 25 was subject to UTIs based upon a prior history of such infections. CMS Br. at 5; P. Br. at 9-10. Petitioner's records reflect that Resident 25 had at least one diagnosed UTI in late May or early June 2002. CMS Ex. 6, at 14. Of course, whether Resident 25 had a history of urinary tract infections and whether the facility knew of her history, if it existed, are not controlling. Even if Resident 25 had never previously suffered a urinary tract infection, that fact would not absolve the facility of the duty to recognize symptoms that might indicate that the resident had developed such an infection. ⁽⁷⁾ The record in this case clearly shows that Resident 25 was suffering from symptoms consistent with a UTI in the days leading to her admission to the hospital. This is not a case where Petitioner recognized Resident 25 was suffering symptoms and failed to adequately treat. Rather, in this case, while a few of Petitioner's CNAs recognized and documented signs and symptoms, Petitioner completely failed to provide necessary care and services to treat Resident 25's signs and symptoms.

In early February 2002, Resident 25 began to exhibit a constellation of changes in her condition from what was observed and documented in January 2002. First, while Resident 25 was documented to have clear skin throughout January, she was documented to have reddened skin in the perineal area beginning on February 1. Next, two CNAs who cared for her in early February recalled that, in addition to reddened skin, the Resident manifested concentrated and/or foul-smelling urine. Further, comparison of Resident 25's consumption records for early February to those of January satisfies me that the records do demonstrate a change in the resident's eating pattern. Finally, on February 6, 2002, Resident 25 ran a fever of 101, which never fully resolved prior to her hospitalization, although it did decrease after the facility gave the resident Tylenol. In the opinion of Ms. McGhee, the state surveyor and a registered nurse, these symptoms should have alerted Petitioner's staff to the possibility that Resident 25 was ill, possibly suffering from a UTI. CMS Ex. 1, at 152.

Petitioner argues generally that the evidence upon which CMS based its conclusion that Resident 25 manifested these symptoms is unreliable, or, in some cases, that CMS misinterpreted the relevant records. For example, Petitioner takes issue with CMS's reliance on the statements of two CNAs employed by Petitioner, who recalled that Resident 25's urine was more concentrated and/or foul-smelling than usual when they cared for her in early February 2002. According to Petitioner, these statements are unreliable because they were obtained by the surveyor in April 2002, approximately two months after the incidents in question. P. Br. at 6. Additionally, Petitioner notes that other care givers and the resident's daughter did not notice anything out of the ordinary with the resident's urine. P. Br. at 7. I find that the reported observation of concentrated and/or foul-smelling urine by the CNAs is entitled to some weight. First of all, both the CNAs who reported that the resident's urine was concentrated and/or foul-smelling also reported that the resident had reddened skin in the perineal area. See CMS Ex. 5, at 16, 19. Their observations of reddened skin are corroborated by the C.N.A. DAILY SKIN INSPECTION form, which appears to have been completed at or close to the time they were caring for Resident 25. ⁽⁸⁾ See CMS Ex. 6, at 4. This suggests to me that the recollections of the CNAs had not become unreliable since the time of the events in question. Second, the fact that other care givers did not recall anything out of the ordinary with regard to Resident 25's urine does not lead to the conclusion that the CNAs who observed symptoms were mistaken. Petitioner has produced no evidence to contradict the CNAs that reported that Resident 25's urine smelled foul or that her skin was red, but only questions their recall some months later. Even if there were real discrepancies in the reports of different CNAs who observed Resident 25, it was Petitioner's obligation to capture the observations, to assess or evaluate those observations, to ensure that Resident 25's treating doctor was fully informed, and to ensure that nursing and CNA staff delivered necessary care and services. In this case, there is a dearth of documentation that the observations of any of the CNAs were either recorded or reported, verified, assessed and/or evaluated, and further investigated.

Petitioner argues that I should not rely on the dietary consumption records to demonstrate a change in Resident 25's eating patterns because the records do not necessarily reflect all the food or fluid Resident 25 consumed. P. Br. at 8. Petitioner points out that, if the resident ate her meal on the hall instead of in the dining room, her consumption would not be recorded on the consumption record. Id. I have taken this argument into account. In analyzing the dietary consumption records, I have not considered the days or meals for which the corresponding space was left blank on the form. Nevertheless, relying only on the days for which Petitioner's staff recorded that Resident 25 refused a meal, it is apparent that the resident refused meals more frequently in early February than she had in January.

Petitioner argues that it was a pattern of behavior for Resident 25 to refuse breakfast because she did not like to get up in the morning. See, e.g., Tr. 134-35. Therefore, according to Petitioner, no inference of a change in behavior should be drawn from the resident's refusal of breakfast during early February 2002. ⁽⁹⁾ Facility records do indicate that, during October 2001 and earlier, there were occasions when Resident 25 refused to get out of bed for breakfast. See, e.g., CMS Ex. 6, at 84. However, the resident's daughter was apparently adamant that her mother should not be allowed to miss meals. See CMS Ex. 6, at 87. The inference that I draw from reviewing these records is that the facility, consistent with the daughter's wishes, was successful in modifying Resident 25's behavior so that she was consistently getting up and eating breakfast during January 2002, as documented in the consumption record. See CMS Ex. 6, at 6. Given the pattern in January, I find that the evidence preponderates in favor of the conclusion that there was a significant change in the resident's eating pattern in early February 2002. In my view, it is more reasonable to measure a change in behavior from the behavior the resident exhibited most recently, rather than to assume that the resident had reverted to a behavior pattern from several months before. ⁽¹⁰⁾

Finally, Petitioner contends that I should view Resident 25's temperature of 101 on February 6, 2002 as, essentially, an isolated spike not indicative of an ongoing illness. See P. Br. at 12-14. Petitioner takes issue with CMS's assertion that the resident had a baseline temperature of 97.8. Id. at 13. According to Petitioner, CMS did not state a basis for its conclusion that 97.8 constituted a baseline for this resident. Id. A facility document entitled "VITAL SIGNS AND WEIGHT RECORD" notes temperatures for Resident 25 beginning on May 4, 2001, skipping to July 1, 2001, and thereafter once monthly until January 9, 2002. CMS Ex. 6, at 5. I note, based on my review of the evidence, that when the recorded temperatures are averaged, the result is 97.8 and the median temperature recorded for the resident is 97.9. There is no evidence in the record as to whether a resident's average or median temperature over a period of eight months is a reliable baseline. Nevertheless, I believe it is reasonable to conclude from these figures that, on average, the resident's temperature tended to be below 98. Based on the recorded temperatures for Resident 25, I conclude that the temperature of 101 recorded on February 6 was significantly elevated for this resident. In addition, Resident 25 continued to have a temperature of 99 or above through February 7, even after the facility staff administered Tylenol. ⁽¹¹⁾ I conclude that these recorded temperatures are consistent with the resident continuing to run a fever during this time. My conclusion is supported by the testimony of Ms. McGhee that a temperature that might be normal for a healthy young adult or child might be a significant elevation for an elderly person. CMS Ex. 1, at 153.

Petitioner points out that it treated the resident by giving her Tylenol and that staff notified the resident's physician. P. Br. at 9. The nursing notes show that Resident 25 had a temperature of 101 on February 6, 2002, that she was given Tylenol, that staff observed the resident to have wheezes in the right lung base, but no cough, congestion, or nasal drainage, and that this information was reported to Resident 25's treating physician who gave instructions to monitor. CMS Ex. 6, at 17. Petitioner's records do not reflect, however, that Resident 25's physician was also told about any of the other signs and symptoms, including the decrease in intake, red perineal area, the foul smelling urine, and the repeated elevation of temperature during the period from February 6 to 8, 2002.

In sum, Petitioner argues that Resident 25 did not manifest symptoms that were significant enough to have raised a duty for the facility to investigate further to determine whether the resident was suffering from a urinary tract infection or other illness. If I were to examine each individual symptom alone, without relation to the other symptoms, I might well conclude that, for instance, a few refused meals, or an episode of fever should not be viewed as indicative of a potentially serious illness. However, in the present case, Resident 25 manifested a variety of symptoms within the same few days in early February. As Ms. McGhee's testimony indicates:

[T]he reddened skin at the peri area and the concentrated foul smelling urine were something that was not the resident's norm. So early on in this process back in the first couple of days in February the nurse aides should have communicated to the charge nurses . . . the reddened skin and the change in the urine concentration and then . . . the development of the fever on top of that, the resident's general weakness and refusal to eat and to drink, those are all new developments that should have sent up red flags that something was wrong with this lady.

CMS Ex. 1, at 152. Indeed, one of the most disturbing aspects of Petitioner's care of Resident 25 is that the record does not reveal any mechanism or system that drew all the resident's symptoms to the attention of the nursing staff so that a comprehensive assessment of her condition could be made. Id. ⁽¹²⁾

In what I take to be essentially the assertion of an affirmative defense, Petitioner argues that Resident 25's decline was inevitable. P. Br. at 15-17. Petitioner's contention appears to be that, even had Petitioner evaluated Resident 25's symptoms earlier, earlier evaluation and treatment would not have altered the course of the resident's illness. Petitioner asserts that, once the resident was admitted to the hospital, she was diagnosed with renal failure and possible myocardial infarction. According to Petitioner, either of these conditions could have caused her death. P. Br. at 16-17. A great deal of the testimony of Petitioner's witness, Lisa Myers, Senior Corporate Clinical Services Director for IHS, was devoted to analyzing Resident 25's hospital records for clinical signs of renal failure. ⁽¹³⁾ Petitioner contends that the resident may have been suffering from a potentially life-threatening condition more serious than a urinary tract infection, while simultaneously maintaining that no signs or symptoms should have alerted Petitioner that something was wrong with the resident. Even if I accept as true Petitioner's contention that Resident 25 suffered from renal failure and or myocardial infarction, and that these conditions may have contributed to her decline and subsequent death, this does not establish that earlier intervention by Petitioner's staff would have been futile. If the facility had recognized and evaluated Resident 25's symptoms earlier, it might have been possible to determine whether or not the resident was suffering from a UTI or other illness and to have treated that illness. If such treatment had been undertaken, the resident might have had a better chance of survival.

3. The amount of the CMP is reasonable.

My conclusion that Petitioner failed to comply substantially with 42 C.F.R. � 483.25, Tag F 309, provides a basis for the imposition of a CMP. The issue remaining is whether the amount of the CMP proposed by CMS is reasonable.

Having found a basis for imposing a CMP, I now consider whether the amount imposed is reasonable, applying the factors listed in 42 C.F.R. � 488.438(f). Emerald Oaks, DAB No. 1800, at 10; CarePlex of Silver Spring, DAB No. 1683, at 16-17 (1999); Capitol Hill Community Rehabilitation and Specialty Care Center, DAB No. 1629 (1997). In reaching a decision on the reasonableness of the CMP, I may not look into CMS's internal decision-making process. Instead, I consider whether the evidence presented on the record concerning the relevant regulatory factors supports a finding that the amount of the CMP is at a level reasonably related to an effort to produce corrective action by a provider with the kind of deficiencies found and in light of the other factors involved (financial condition, facility history, and culpability). I am neither bound to defer to CMS's factual assertions, nor free to make a wholly independent choice of remedies without regard to CMS's discretion. Community Nursing Home, DAB No. 1807, at 25; CarePlex, DAB No. 1683, at 11.

CMS maintains that measured against the applicable factors, the imposition of a per instance CMP of $10,000 is reasonable. There is no evidence in the record concerning the facility's financial condition; thus, I cannot consider that regulatory factor in analyzing the reasonableness of the CMP. Similarly, there is no evidence regarding the facility's compliance history; hence, I have not considered that factor, either. The remaining factors that I must consider are the facility's degree of culpability and the seriousness of the deficiency. CMS has argued that the facility was culpable in failing to follow its own procedures regarding care to the resident. CMS Br. at 9. I do not conclude that the facility failed to follow its own policies in caring for the resident. However, Petitioner was deficient in this case by failing to have a procedure in effect which would ensure that residents' symptoms were communicated to nursing staff in a coordinated and timely manner. The absence of such a system led to Resident 25's symptoms being overlooked or addressed inadequately. Resident 25 was frail and suffered from a number of chronic conditions that put her at risk if she were to develop an infection that remained undiagnosed and untreated. Had Petitioner been more alert to the signs that Resident 25 might be ill, signs staff detected but that were not comprehensively reviewed or evaluated, the resident's doctor could have been more fully advised, permitting more accurate and timely treatment or earlier hospitalization if necessary. Petitioner's is culpable for its failure.

In this case, CMS has proposed a per instance CMP and whether or not the deficiency posed immediate jeopardy does not directly impact the amount of the per instance CMP that can be imposed. 42 C.F.R. � 488.408(d) and (e). However, CMS argues that the seriousness of the deficiency in this case is demonstrated by the fact that it was cited at the immediate jeopardy level. This is a statement of the obvious, and is not particularly helpful in determining a reasonable CMP amount. The failure to address the resident's symptoms clearly placed her at risk for serious illness or death. The resident ultimately expired and, while I would acknowledge that, because of her age and poor health, the resident might have died in any case, I do not view this as mitigating the seriousness of the deficiency.

Considering Petitioner's culpability and the seriousness of the regulatory violation, I conclude that $10,000 is a reasonable per instance CMP.

IV. Conclusion

For the foregoing reasons, I conclude that Petitioner violated 42 C.F.R. � 483.25 (Tag F 309), which is the basis for the imposition of a remedy, and a $10,000 per instance CMP is reasonable.

Keith W. Sickendick

Administrative Law Judge

1. Citations are to the version of the regulations in effect at the time of the survey.

2. 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.

3. CMS Ex. 1 is a transcript of proceedings before the Missouri Administrative Hearing Commission conducted November 14, 15, and 19, 2002, involving the Petitioner and the state agency related to the proposed revocation of Petitioner's state license. The decision of the Hearing Commission has not been offered as evidence in the proceeding before me. CMS offered the Hearing Commission transcript as a record of prior recorded testimony in lieu of calling the witnesses who testified in that proceeding. The entire Hearing Commission transcript was marked as CMS Ex. 1 and is retained with the record of the proceedings before me. However, only the testimony of Lisa McGhee, as recorded in CMS Ex. 1, at 102-219 and 441-50, was accepted as evidence to be considered as part of the CMS case-in-chief. Tr. 24-50, 82-3. Subsequently, CMS reoffered the testimony of David Mehr, M.D., as recorded in CMS Ex. 1, at 224-327 and 458-85, as evidence in rebuttal of testimony adduced by Petitioner in its case-in-chief. I admitted the testimony of Dr. Mehr as recorded in CMS Ex. 1 for the limited purpose of rebuttal. Tr. 319-28. However, the testimony of Dr. Mehr has no impact upon my decision in this case.

4. Ms. McGhee appeared by telephone pursuant to the agreement of the parties. Tr. 106-07.

5. The Health Care Financing Administration (HCFA) is the former name of CMS.

6. CMS did not call Ms. McGhee to testify but offered the transcript of her testimony before the Missouri Administrative Hearing Commission. CMS Ex. 1. Although Petitioner cross-examined Ms. McGhee before the Hearing Commission, Petitioner was given another opportunity to cross-examine her via telephone in the proceeding before me.

7. It is axiomatic that residents of long-term care facilities are at risk for urinary tract infections. "Symptomatic UTIs are the most common infection experienced by residents of long-term care facilities." P. Ex. 13, at 1.

8. Petitioner does not dispute that the skin inspection form documents reddened skin for Resident 25 during early February 2002. P. Br. at 6. Petitioner notes only that not every day from February 1 through February 8 is documented. Id. Petitioner also points out that reddened skin is not necessarily indicative of an infection or other life-threatening condition. Id. Of course, reddened skin by itself, is not necessarily indicative of a serious illness. But it is the presence of reddened skin, together with the other symptoms, that as a whole should have raised the possibility of an infection or other serious illness.

9. I note, however, that Resident 25 refused not only breakfast, but lunch and afternoon snack as well, on February 5 and 6, 2002. CMS Ex. 6, at 7.

10. In an apparent inconsistency, Petitioner presented evidence that Resident 25 may have experienced decreased appetite due to starting on antidepressant therapy with the drug Zoloft. See Tr. 121-22, 126. Petitioner's Director of Nursing testified that loss of appetite is a common side effect of such medications. Tr. 122. I gather that Petitioner would like me to conclude that, if the resident experienced a change in eating habits, it was due to the medication rather than to any illness the resident may have been suffering. There is insufficient evidence from which I can draw such a conclusion. First of all, Zoloft was ordered for Resident 25 on January 22, 2002. CMS Ex. 6, at 61. From January 22 through January 31, Resident 25 is not documented as having refused any meals. CMS Ex. 6, at 6. And, even if the resident's refusal of meals in early February might be linked to her beginning antidepressant therapy after January 22, there is simply no evidence in the record that such an explanation for the resident's decreased appetite was ever considered or explored by Petitioner's staff during the period in question.

11. On February 7, 2002, the Resident's temperature was noted to be "98.9 AX [axillary]." CMS Ex. 6, at 19. An axillary temperature is .5 to 1 degree lower than an oral temperature. See CMS Ex. 1, at 125.

12. Petitioner's Director of Nursing testified that the facility conducts a "clinical review" each day to identify residents who need additional interventions. Tr. 117. During that review, the staff reviews a written document called a "24-hour report" on which concerns about particular residents are documented. Id. The 24-hour report is a communication tool between the nursing shifts on each wing. Id. Petitioner has pointed to no example of this 24-hour report regarding Resident 25, nor have I discovered one.

13. Ms. Myers did not treat or observe Resident 25 and her curriculum vitae is not in evidence. She testified that she is a registered nurse with experience working as a Director of Nursing in long-term care facilities. Tr. 138.