SUBJECT:

Homestead of Denison,

Petitioner,

Centers for Medicare & Medicaid Services

DECISION

This case came before me pursuant to a request for hearing filed by Homestead of Denison (Petitioner), on November 16, 1999, in accordance with section 1128A(c)(2) of the Social Security Act (Act) and 42 C.F.R. §§ 488.408(g) and 498.40. A revised request for hearing was filed on December 2, 1999.

Petitioner is a skilled nursing facility (SNF) participating in the Medicare/Medicaid programs. The Texas Department of Human Services (TDHS) concluded a survey on September 23, 1999, finding that Petitioner was not in substantial compliance with federal Medicare requirements for nursing home participants. As a result, the Centers for Medicare and Medicaid Services (CMS) imposed the remedy of denial of payment for new admissions (DPNA) from October 2, 1999 through October 11, 1999.

I held a hearing in Fort Worth, Texas, on April 10, 2001. CMS offered 10 proposed exhibits identified as CMS Exhibits (CMS Exs.) 7, 9, 17-21, 24, 28, and 29. CMS's proposed exhibits were admitted without objection. Petitioner offered four proposed exhibits. These were admitted into the record as Petitioner's Exhibits (P. Exs.) 6, 8, 9, and 10, without objection. Neither party introduced the nursing summaries pertaining to Resident Number One, that covered the period from January to September 1999. Thus, I obtained these summaries from Petitioner and admitted them into the record as ALJ Exhibit (ALJ Ex.) 1.

Based on the testimony offered at the hearing, the documentary evidence, the arguments of the parties, and the applicable law and regulations, I find that from October 2, 1999 through October 11, 1999, Petitioner was in substantial compliance with Medicare participation requirements. I further find that CMS is not authorized to impose the DPNA remedy against Petitioner.

Petitioner is considered a long-term care facility under the Act and regulations promulgated by the Secretary of the Department of Health and Human Services (Secretary). The statutory requirements for participation by a long-term care facility are found at sections 1819 and 1919 of the Act and at 42 C.F.R. Part 483.

Sections 1819 and 1919 of the Act invest the Secretary with authority to impose remedies against a long-term care facility for failure to comply substantially with participation requirements.

Pursuant to the Act, the Secretary has delegated to CMS and the States the authority to impose remedies against a long-term care facility that is not complying substantially with federal participation requirements. 42 C.F.R. Part 483 provides that facilities which participate in Medicare may be surveyed on behalf of CMS by State survey agencies in order to ascertain whether the facilities are complying with participation requirements. 42 C.F.R. §§ 488.10-488.28. The regulations contain special survey conditions for long-term care facilities. 42 C.F.R. §§ 488.300-488.335. Under Part 488, a State or CMS may impose remedies against a long-term care facility where a State survey agency ascertains that the facility is not complying substantially with participation requirements. 42 C.F.R. §§ 488.406, 488.408 and 488.430. Specifically, 42 C.F.R. § 488.417(b), 42 C.F.R. § 488.414, and §§ 1819(h)(2)(D), (E) and 1919(h)(2)(C), (D) of the Act authorize CMS to deny payment for all new admissions in any case where the facility is not in substantial compliance by the third month after the last day of the survey identifying the deficiency, or when a provider has been found to have furnished substandard care on the last three consecutive standard surveys. The penalty may start accruing as early as the date that the facility was first out of compliance until the date substantial compliance is achieved or the provider agreement is terminated.

The regulations define the term "substantial compliance" to mean:

. . . 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.

Remedies by CMS are appropriate only after CMS makes a prima facie showing that the facility has failed to comply substantially with participation requirements. To prevail, a long-term care facility must overcome CMS' showing by a preponderance of the evidence. Hillman Rehabilitation Center, DAB No. 1611 (1997), aff'd sub nom, Hillman Rehabilitation Center v. United States, Department of Health and Human Services, Health Care Financing Administration, No. 98-3789 (GEB), slip op. at 25 (D.N.J. May 13, 1999).

The Act and regulations make a hearing available before an administrative law judge (ALJ) to a long-term facility against whom CMS has determined to impose a remedy. Act, section 1128A(c)(2); 42 C.F.R. §§ 488.408(g) and 498.3(b)(12), (13). The hearing before an ALJ is a de novo proceeding. Anesthesiologists Affiliated, DAB CR65 (1990), aff'd, 941 F.2d 678 (8^th Cir. 1991).

II. Issues

1. Whether the facility was complying substantially with federal participation requirements on the dates CMS determined to impose a DPNA; and

2. Whether there is a basis for the imposition of remedies against Petitioner.

III. Findings and Discussion

The findings of fact and conclusions of law noted below in italics are followed by a discussion of each finding.

1. The facility was in substantial compliance with federal participation requirements from October 2, 1999 through October 11, 1999.

The applicable regulation at 42 C.F.R. § 483.25, entitled "Quality of care," provides:

[e]ach 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 comprehensive assessment and plan of care.

A. Resident Number One (R1)

The facility adequately assessed and treated R1's lower extremity edema.

CMS Ex. 20, at 3-5.

Based on observations, interviews and record reviews during the course of a survey conducted on September 22, 1999, a surveyor noted at 9:50 a.m. that R1 had significant bilateral pedal edema. The Assistant Director of Nursing (ADON) stated that this was not a new condition. A review of the resident's clinical record revealed swelling and inflammation of her right leg on May 7, 1999, that her physician attributed to arthritis. On May 10, 1999, according to the surveyor, a nurse noted that R1 had 2+ edema, and was given Tylenol to relieve it. It was pointed out by the surveyor that Tylenol was not the appropriate remedy since it lacked anti-inflammatory properties. The clinical record also indicated that the treating physician was not notified.

From May 10, 1999 until June 17, 1999, when R1 was visited by her physician, no notes were made regarding R1's lower extremities. At that time, the resident was prescribed Maxzide, which was to be given daily and then every other day once the edema subsided.

For the month of September 1999, no assessment was found by the surveyor regarding the resident's increased lower extremity edema, and there was no evidence that the physician had been notified of the significant edema observed on September 22, 1999.

The surveyor concluded that the ADON's assessment, that the edema was not a new problem and the facility's failure to assess R1's condition and notify the physician of changes in her condition, placed R1 at risk for discomfort and/or clinical complications.

Mr. John Allen, the State surveyor, testified that on September 22 and 23, 1999, he conducted a follow-up survey of Petitioner's facility. Allegedly, he found Petitioner to be out of compliance with the requirement to provide R1 the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being. This conclusion was premised on the ADON's statement that "the edema was not a new problem" and the facility's failure to assess R1's condition and notify the physician of changes in her condition. CMS Ex. 20, at 4, 5.

On direct examination, Mr. Allen reiterated what he had previously reported in the Statement of Deficiencies (Form 2567). See Transcript (Tr.) at 36-47. However, he admitted making several erroneous findings. Initially, he recognized the inaccuracy of his claim that Tylenol was improperly administered as an anti-inflammatory agent for pedal edema. CMS Ex. 20, at 4; Tr. at 44, 66. He attempted to explain his misstatement by saying that he meant to indicate that Tylenol was Petitioner's only intervention for the edema. Mr. Allen had also concluded that, from May 10, 1999 until R1 was visited by her treating physician on June 17, 1999, no notes were made regarding her lower extremities. This, he admitted, was another mistake on his part, inasmuch as there were several assessments recorded in the record between May 10 and June 17, 1999. Tr. at 71. Mr. Allen noted in the Form 2567 that one of the reasons for finding Petitioner non-compliant, with respect to the care given to R1, was the ADON's statement that lower extremity edema was not a new issue with that resident. CMS Ex. 20, at 4. He acknowledged, however, that R1 had been treated with Maxzide for water retention since 1997. Tr. at 69. In that context, the ADON's statement that the resident's lower extremity edema was not a new condition could in no way constitute a basis for a deficiency finding.

The surveyor determined that the significant edema he observed on September 22, 1999, was a change in the resident's condition that should have been reported to her physician. The surveyor concluded that the facility's failure to do so put the resident at risk for discomfort and/or clinical complications. Tr. at 62; CMS Ex. 28 at 48.

Mr. Allen noted there are several conditions associated with lower extremity edema. The most significant of these, he said, is congestive heart failure. Tr. at 4. In his opinion, if the edema had been left without assessment or intervention, it could have advanced to congestive heart failure. Tr. at 62. However, he admitted that if R1 had been experiencing an acute onset of lower extremity inflammation, there might not have been a need to notify the physician immediately. According to Mr. Allen, it might have been sufficient to elevate her legs. Tr. at 60, 61. This testimony was consistent with that of Ms. Sherry Caylor, Petitioner's regional nurse consultant. She stated that most dependent edema will go away with just nursing measures alone of elevating the feet. Tr. at 169. Ms. Caylor testified that, in the case of R1, Petitioner's staff had been monitoring her for edema for a long time. Ms. Caylor further stated that with position changes, dietary precautions, and Maxzide, R1's condition was kept under control. In Ms. Caylor's opinion, R1's edema was not a condition that would be cured but, rather, could be kept under control with proper daily management. Tr. at 169, 170. In this regard, Ms. Caylor referred to the facility's medication sheet for R1 that reflected adequate control of R1's lower extremity swelling. P. Ex. 9. At 8:00 a.m. on September 22, 1999, the resident had no edema (P. Ex. 9, at 4), but developed swelling developed by mid-morning. According to Ms. Caylor, R1's swelling could be attributed to her sitting position. Ms. Caylor testified that swelling could have developed within an hour after sitting. Tr. at 207. Pertinent to that is the reference in the monthly summaries that the resident may have been sitting too much. ALJ Ex. 1, at 28, 34; P. Ex. 6, at 14. Consistent with the resident's practice of spending much time in her chair, the facility placed her near the nurse's station where she could be observed. Ms. Caylor added that, at some point, one of the staff would notice the resident's lower extremities and get her feet up. Tr. at 207. I conclude that the facility had been managing R1's edema for a long time and was aware of the condition's ups and downs. What occurred on September 22, 1999, did not call for immediate notification of her physician, nor was it a significant change in her condition.

Ms. Caylor added that it is incorrect to say that pedal edema could lead to congestive heart failure. She stated that edema of the lower extremities may be a sign and symptom of congestive heart failure, but not the cause of it. In this particular case, she noted that the resident had no respiratory distress and her vital signs were normal. Tr. at 208. I find the opinion of Ms. Caylor regarding the relationship between pedal edema and congestive heart failure more persuasive than that of Mr. Allen.

In view of the foregoing, I find that R1 was being properly managed for her pedal edema and was not exposed to risk of congestive heart failure or other discomfort due to the care she received. Neither the ADON's response that the edema "was not a new condition," nor the decision not to call R1's physician on September 22, 1999, constituted a basis for a finding of noncompliance. I find that the alleged deficiency posed no greater risk to resident health or safety than the potential for causing minimal harm.

B. Resident Number Three (R3)

CMS did not establish a prima facie case that Petitioner placed R3 at risk for complications of untreated infection by failing to follow up on ordered laboratory tests.

CMS Ex. 20, at 6, 7.

A closed record review⁽¹⁾ revealed that on September 3, 1999, R3 complained of difficult and painful urination. The treating physician ordered a urinalysis and a culture and sensitivity test. The specimen was obtained and forwarded to the laboratory (lab) for testing. The tests were completed on September 5, 1999 at 8:11 a.m., and the results were called in to the resident's physician at 11:35 a.m. The resident expired of apparent heart problems two days later. CMS Ex. 20, at 6, 7.

The surveyor concluded that the failure to follow up on the ordered lab test placed R3 at risk for complications of untreated infection.

The State surveyor, Ms. Sharon White, testified that the facility sent the specimen to the lab for testing on September 3, 1999, and there was no indication in the nurses' notes that the test results were pursued. Tr. at 105. According to Ms. White, that brought about a delay that allowed an infection to go untreated. Ms. White was of the opinion that untreated urinary tract infections (UTI)⁽²⁾ in elderly women could cause an electrolyte imbalance. This, Ms. White reasoned, can lead to mental changes and cardiac problems. Because of R3's history of having an enlarged heart and hypertension, Ms. White testified her heart would have to work harder. Ms. White concluded that the electrolyte imbalance, brought about by the UTI, would cause arrhythmia, making the heart beat "a strange rhythm." According to Ms. White, the heart could go faster or slower, "or skip a beat or something like that." Tr. at 109.

It is true that it is sufficient for CMS to show that the resident was put at risk of injury. Actual harm need not be established. However, that risk cannot be speculative or imagined. In the case before me, CMS has offered no persuasive explanation for the surveyor's prognostic theory on possible complications from untreated UTI, nor does that theory find support in the medical literature.

Ms. White asserted that a delay in treating R3's UTI put her at risk of developing an electrolyte imbalance that could cause the heart to go into "a strange rhythm" or go faster or slower, or "skip a beat or something like that." Tr. at 103, 104, and 109. That explanation is certainly not very scientific. Moreover, I find such an opinion to be conclusory, and contrary to medical literature that is the resulting distillate of a plural intelligence.

The most widely accepted view in the medical community does not mention mental changes or heart disease as a possible complication arising from UTI. Although chronic pyelonephritis is recognized as a possible complication, probably 10% or fewer of asymptomatic bacteriuria patients develop renal failure attributable to the UTI. Hypertension as a possible complication is even more rare. Lawrence M. Tierney, et al., Current Medical Diagnosis and Treatment, 663 (30th ed. 1991).

It is noted in other literature that:

Urethritis can lead to scarring of the urethra and formation of a urethral stricture. Cystitis, provided there is no upward spread to the kidneys, does not usually produce complications.

The American Medical Association Encyclopedia of Medicine (1989).

It is significant that the statistics alluded to above refer to asymptomatic patients. In these, the UTI tends to go unnoticed and untreated until complications appear. Even in such cases, the complications are rare. Furthermore, the same literature supports the view that "many elderly patients tolerate UTI well." Current Medical Diagnosis and Treatment, at 663. Consequently, the allusion to R3's age as an added gravamen in this case is misplaced. Tr. at 103. Additionally, Ms. White testified that the resident had complained of pain and difficulty urinating. Tr. at 98. From these symptoms, the surveyor leaped to the conclusion that because R3 had "such severe symptoms on the 3^rd, she would have expected something to have been done on the 4^th." Tr. at 102. Pain and difficulty urinating are common symptoms of UTI. William B. Abrams, M.D. & Robert Berkow, M.D., The Merck Manual of Geriatrics, 620 (1990).⁽³⁾ There is no evidence that R3 experienced additional symptoms, nor has there been a showing as to the severity of the symptoms she did have. The use of hyperbole is no substitute for the proper laying of an evidentiary foundation.

CMS attached medical literature to its posthearing brief, yet none is persuasive of its theory that UTI may lead to mental changes or cardiac problems. Excerpts submitted by CMS from the Clinical Nursing treatise do indicate that:

Although patients in critical care units are the most vulnerable to hospital acquired infections, a large subset of patients in general hospital units is also vulnerable. Patients particularly susceptible to septic shock are the elderly . . . or [patients with] urinary tract infection[s].⁽⁴⁾

June M. Thompson, R.N., M.S., et al., Clinical Nursing, 51 (1986).

CMS has failed to show, through competent testimony or other evidentiary approach, that the facility unduly exposed R3 to septic shock because of an untreated UTI. It cannot be assumed that a four day wait to obtain culture and sensitivity test results necessarily placed the resident at risk.

Ms. Sherry Caylor, Petitioner's nurse consultant, testified that R3 had been in the hospital on ampicillin, a full spectrum antibiotic. Tr. at 219. Shortly after returning to the facility, the resident developed symptoms that appeared to be consistent with UTI. Ms. Caylor reasoned that since the resident was afebrile and not showing any additional symptoms, waiting for the culture results posed no risk. Tr. at 221; see also CMS Ex. 29, at 10. Ms. Sharon White, the State surveyor, testified that the elderly have a normal temperature of 96.8ºF. She was of the opinion that R3's temperature of 98.6ºF should have been considered suspicious. Tr. at 100, 101; see CMS Ex. 29, at 10. However, it

is one thing to say that the resident had a suspiciously elevated temperature, and another that she had severe symptoms requiring urgent attention to prevent serious complications.

CMS argues that Petitioner failed to consult with R3's physician when there was a significant change in her physical condition or clinical complications. CMS Brief at 20. CMS additionally contends that R3 was in distress because she had an elevated temperature and other more severe symptoms. In this regard, CMS points to its Exhibit 29 at page 10 in support of the assertion that, on September 5, 1999, the resident's symptoms had intensified. This, CMS argues, should have prompted a call to her physician. Id. at 21. These assertions by CMS are without support in the record. On September 3, 1999, the resident was noted to be experiencing difficult and painful urination. The succeeding entries in the nurse's notes, up until R3's demise on September 7, 1999, do not refer to a significant change in symptoms associated with UTI. The nurse's notes on September 5^th indicate that, at 9:00 a.m., R3 complained of nausea. But CMS advanced no evidence to establish a nexus between that symptom and UTI. In fact, R3 had experienced similar symptoms days earlier, which were not associated with UTI. CMS Ex. 29, at 9. Moreover, R3's vital statistics reported on that date are not indicative of any distress. In fact, on the following day, the record specifically stated that she was in no distress. Id. at 10. I fail to detect a significant change in R3's condition that merited a call to her physician.

CMS also argues that the testing protocols outlined in Diagnostic Microbiology reflect that, of the nine tests available for gram negative bacteria, such as the E. coli found in R3's lab results, only one test has a grow-out rate of four to 72 hours. See Betty A. Forbes, Ph.D., et al., Diagnostic Microbiology, 183-184, 425 (10th ed. 1998). The remaining eight tests ranged from four to 18 hours and 18 to 48 hours. It is CMS's position that, even if the test took 72 hours, the facility should have contacted the lab not later than September 6, 1999, for an update on the results of the lab tests. I agree with CMS that, although the nurse's notes show an entry on September 6, 1999, the urine analysis was still pending. However, that is not sufficient evidence for the conclusion that the facility made an inquiry to the lab to determine the status of the test results. CMS Ex. 29, at 10. On the other hand, the facility's decision to wait up to four days before inquiring about the culture and sensitivity test results, in accordance with the lab's protocol, cannot be considered a dereliction of its duty. See P. Ex. 10, at 1. It is true that the facility changed labs in order to track specimens more closely. However, I do not find those new procedures to be evidence of a failure to be in substantial compliance in the case at hand. The alleged deficiency posed no greater risk to health or safety than the potential for causing minimal harm.

3. CMS has not met its burden to show a basis for the deficiency cited against Petitioner.

CMS has not satisfied the criteria for imposing remedies at the "less than immediate jeopardy" level. CMS has not established a prima facie case that, as of October 2, 1999, Petitioner was not complying substantially with participation requirements at 42 C.F.R. § 483.25. Indeed, there is not only an absence of a prima facie case of noncompliance, but the preponderance of the evidence demonstrates that Petitioner was complying substantially with 42 C.F.R. § 483.25. Consequently, CMS is not authorized to impose a DPNA from October 2, 1999 through October 11, 1999.

IV. Conclusion

I conclude that CMS incorrectly determined that beginning October 2, 1999 through October 11, 1999, Petitioner was not complying substantially with federal participation requirements in the Medicare program at the "less than immediate jeopardy" level. I find that Petitioner was, in fact, in substantial compliance with the federal requirements of 42 C.F.R. § 483.25.

José A. Anglada

Administrative Law Judge

1. When a resident is no longer in the facility, the resident's record is pulled and filed as a closed record. Inasmuch as direct observation is not possible, reliance is placed basically on the documents in the closed record. Tr. at 94.

2. UTI is a bacterial infection of the urethra, bladder, ureter or kidneys.

3. Found at Attachment 4 to CMS's posthearing brief.

4. Septic shock as a complication from UTI had not been previously argued by CMS.