SUBJECT:

Scallop Shell Nursing Home,

Petitioner,

Centers for Medicare & Medicaid Services

DECISION

Petitioner, Scallop Shell Nursing Home, is certified to participate in the Medicare and Medicaid programs as a provider of services. Petitioner challenges the Centers for Medicare & Medicaid Services' (CMS) determination that it was not in substantial compliance with program participation requirements and CMS's imposition of a per-instance $1,000 civil money penalty (CMP). ⁽¹⁾ For the reasons discussed below, I find that at all relevant times Petitioner was in substantial compliance with participation requirements and that CMS's determination to impose the $1,000 per-instance CMP is unsupported by the record considered as a whole.

I. Background

The Rhode Island Department of Health (State survey agency) conducted a complaint survey at Petitioner's facility on January 5, 2001. The State survey agency determined that Petitioner was out of compliance with federal requirements for nursing facilities participating in the Medicare and Medicaid programs. They found the most serious deficiency to be an isolated deficiency that constituted actual harm not amounting to immediate jeopardy (Level G) pursuant to F Tag 157 (notification of rights and services). ⁽²⁾ On February 2, 2001, the State survey agency made a revisit and determined Petitioner to be back in substantial compliance. On June 4, 2001, CMS sent Petitioner a letter notifying it that, as a result of the survey findings, CMS was imposing a per-instance CMP of $1,000.

By letter dated August 1, 2001, Petitioner requested a hearing. The case was assigned to me for hearing and decision. I held a hearing in the case on April 7, 2003. At the hearing, I admitted into evidence CMS exhibits (CMS Exs.) 1 - 8 (Tr. at 12) and Petitioner's exhibits (P. Exs.) 1 - 5 (Tr. at 12 - 13). ⁽³⁾ CMS submitted a brief (CMS Br.) to which Petitioner responded (P. Br.). CMS did not submit a reply.

Three witnesses testified at the hearing. Adele F. Renzulli, R.N., testified on behalf of CMS. Ms. Renzulli is the State survey agency surveyor who conducted the survey of Petitioner on January 5, 2001. Testifying for Petitioner were Evelyn McCall, R.N., Petitioner's Director of Nursing Services, and Gail A. King, R.N., a licensed nursing home administrator and registered nurse who is a consultant for long-term care facilities.

II. Issues

1. Whether Petitioner was out of substantial compliance with participation requirements;

2. Whether the $1,000 CMP imposed by CMS against Petitioner is reasonable.

III. Statutory and Regulatory Background

The Social Security Act (Act) sets forth requirements for nursing facilities participating 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 facilities participating in the Medicare program are found at 42 C.F.R. Parts 483, 488, and 489.

To participate in the Medicare program, a nursing facility must maintain substantial compliance with program requirements. 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.

If a facility is not in substantial compliance with program 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 program requirements, or for each instance that a facility is not in substantial compliance. 42 C.F.R. §§ 488.430(a); 488.440. If CMS imposes a per-instance CMP, the CMP will be in the range of $1,000 - $10,000. 42 C.F.R. § 488.438(a)(2).

IV. Burden of Proof

As an evidentiary matter, CMS must set forth a prima facie case that Petitioner was not in substantial compliance. Petitioner then has the burden of coming forward with evidence sufficient to establish the elements of any affirmative argument or defense, and bears the ultimate burden of persuasion. To prevail, Petitioner must prove, by a preponderance of the evidence, that it was in substantial compliance with relevant statutory and regulatory provisions. Batavia Nursing and Convalescent Center, DAB No. 1904 (2004); Batavia Nursing and Convalescent Inn, DAB No. 1911 (2004); Hillman Rehabilitation Center, DAB No. 1611 (1997), aff'd Hillman Rehabilitation Center v. U.S., No. 98-3789 (GEB), (D.N.J. May 13, 1999).

V. Findings of Fact, Conclusions of Law, and Discussion

I make findings of fact and conclusions of law to support my decision in this case. I set forth my findings below, in italics, as separate headings.

1. Petitioner was in substantial compliance with the participation requirement at 42 C.F.R. § 483.10(b)(11) (F Tag 157 on the statement of deficiencies (CMS 2567 or 2567) dated January 5, 2001) at all relevant times.

42 C.F.R. § 483.10(b)(11)(i)(B) is entitled "notification of changes" and provides, among other things, that a facility must immediately inform a resident's physician when there is 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).

The 2567 alleges that, based on a complaint investigation, a clinical record review, and staff interviews, Petitioner failed to: 1) notify Resident 14's physician of a deterioration in the resident's health; or 2) make a decision to transfer or discharge the resident from the facility. The case, however, focuses only on the first allegation: Petitioner's failure to notify Resident 14's physician of a deterioration in the resident's health over an eight-day period. ⁽⁴⁾

The 2567 asserts that

Resident ID# 14 entered the facility from the hospital on 6/15/00 with a diagnosis of dehydration, congestive heart failure and hyperkalemia. This resident was alert and oriented at the time of admission with a full code status. Nursing documentation on 6/18/00 on the 7am to 3pm shift indicated the resident to have shortness of breath, thigh to feet edema, and confusion. Nursing documentation on 6/18/00 on the 3pm to 11pm shift indicated confusion, shortness of breath while at rest in oxygen, color dusky, lips pale, weak. Additionally, on 6/21/00 nursing documentation on the 3pm to 11pm shift indicated confusion, gross edema thighs to feet, dyspnea upon exertion, and lung sounds with bilateral crackles. Interview with the Director of Nursing (DNS) confirmed that on 6/22/00, per request of resident's friend, the Medical Director was contacted and a request made for the Medical Director to assess this resident. The Medical Director asked that this resident be sent to the emergency room for an evaluation. Nursing note on 6/22/00 indicated a call from the Medical Director informing the facility the resident expired in the emergency room on 6/22/00. Interview with staff indicated there is no documented evidence to indicate that any physician had been notified of the resident's deteriorating condition. Interview with the resident's physician indicated that the physician was not notified of the resident's deteriorating condition. There is no evidence to indicate that any physician had been notified of this resident's deteriorating condition.

CMS Ex. 1, at 2.

While I find that the evidence and argument adduced by CMS establish a prima facie case of noncompliance in the absence of rebuttal, I find that Petitioner's evidence, which includes the testimony of Ms. McCall, the written opinions of the physician treating Resident 14, and the written opinion of the physician whose care Resident 14 was about to enter, and the arguments based on that evidence, have successfully rebutted CMS's case. My review of the record leads me to conclude that no single one of, or combination of, the day-to-day alterations in Resident 14's physical condition constituted the level of "significant change" contemplated by the regulations. Nor is the fact that Resident 14 died on June 22, soon after her hospital admission, suggestive of any other conclusion, since both physicians concluded that her death was unforeseeable. P. Exs. 3, at 1; 5. My examination of the evidence supports their views.

It may be helpful explicitly to state here what is implicit throughout this decision, as it was implicit throughout the hearing: this is a very close case on its facts and my ruling is the quintessential "fact-bound" decision. Both sides have contributed to a cogent and detailed body of evidence and have argued the case skillfully. Precisely because the case has been so carefully presented is it possible for me to sift the record for the telling details that compel this outcome. Nor should my ruling today be understood as holding that the facts CMS has proved here could never support a finding of deficiency: I believe that CMS has established a prima facie case, but I also believe that Petitioner has successfully refuted that prima facie case.

As noted above, the instant regulation defines a "significant change" as "a deterioration in health, mental, or psychosocial status in either life-threatening conditions or clinical complications." 42 C.F.R. § 483.10(b)(11)(i)(B). Ms. Renzulli, the surveyor who surveyed Petitioner's facility on January 5, 2001, and CMS's only witness in this case, stated a significant change "would be if there is a change in a person['s] mental, psychosocial or clinical condition that would warrant changes in treatment, such as medications, et cetera, and changes in the management of the plan of care." Tr. at 82 - 83; see also Tr. at 19 - 21. Ms. Renzulli's applied definition of significant change is closer to the regulatory definition of a significant change in the context of resident assessments where, at 42 C.F.R. § 483.20(b)(2)(ii), a significant change is defined, in pertinent part, to mean a major decline or improvement in a resident's status that will not normally resolve itself without further intervention by staff or by implementing standard disease-related clinical interventions. Ms. Renzulli's applied definition of a significant change, and the definition of a significant change in the context of resident assessments, both appear to be more stringent than the definition in the regulation at issue. However, below, I am applying this more stringent standard and evaluating Resident 14's eight days at Petitioner's facility to determine whether changes in Resident 14's physical, mental, or psychosocial status occurred in a context that would normally require clinical intervention, especially with regard to deviations from the resident's baseline condition (see below) and her physician's familiarity with her clinical history and status. If the facility meets this stricter standard then, a fortiori, it will have satisfied the regulation here. I note here Judge Kessel's perceptive and instructive discussion in the case of Beverly Health & Rehabilitation - Springhill:

There is a general requirement in the regulations that a facility immediately inform a resident's physician of any deterioration in a resident's health status and inform the physician of any need to change the manner in which care is provided to a resident . . . . How this general notification requirement is implemented is left up to the facility. No specific act (e.g., notifying a physician of the quantity of fluid intake by a resident) is required by the regulation. What constitutes adequate notification in a particular case is a matter of agreement between a resident's treating physician and a facility's staff, although that notification must satisfy the general requirements of the regulation.

Beverly Health & Rehabilitation - Springhill, DAB CR553, at 18 (1998), aff'd DAB No. 1696 (1999).

To understand Resident 14's condition at Petitioner's facility, it is necessary to determine Resident 14's "baseline." Ms. Renzulli testified that, as a standard of practice, nurses are expected to familiarize themselves with a particular resident's baseline (as established from diagnoses and signs and symptoms present at the start of care), and to watch for changes from the baseline, or the appearance of an abnormality. Tr. at 21 - 23; CMS Br. at 3. CMS, citing Ms. Renzulli's testimony, asserts that an "abnormality" could be a blood pressure reading that is high for a particular patient, or bleeding or wound drainage that is not expected or is excessive, or a sign or infection, such as a body temperature reading that falls above the average temperature range. CMS Br. at 3, n.3, citing Tr. at 20. And, Ms. Renzulli indicated that when a physician cares for a patient, that physician understands the range of normal signs for that patient. Tr. at 22 - 23.

Assuming Ms. Renzulli's definition of a "baseline," I will evaluate Resident 14's condition over her eight days in Petitioner's facility against her specific baseline condition, as established by her medical history, diagnoses, and treatment at South County Hospital just prior to her admission to Petitioner's facility, and her assessment upon entry to Petitioner's facility. I also evaluate the record against the opinions expressed in the letters of Resident 14's treating physician throughout Resident 14's sojourn at the facility, Jeffery Bandola, M.D. ⁽⁵⁾, and John Barrett, D.O., the physician to whose service Resident 14 was being transferred when sent to the hospital on June 22. ⁽⁶⁾

Resident 14, a 79-year-old woman, was admitted to Petitioner's facility on June 15, 2000, following a five-day hospitalization at South County Hospital. CMS Exs. 3, 4. Resident 14 presented at the hospital because of difficulty with eating and increased shortness of breath. CMS Ex. 3, at 1 - 2. Her evaluation showed dehydration and hyperkalemia, accompanied by "continued" lower extremity edema. Id. Her past medical diagnosis included congestive heart failure, chronic obstructive pulmonary disease, hypertrophic cardiomyopathy, ventricular hypertrophy, pulmonary hypertension, and her diagnoses at the hospital included dehydration, dyspnea, and hyperkalemia. ⁽⁷⁾ Id. Her chronic conditions (the COPD, hypertension, and hypertrophic cardiomyopathy) were assessed as stable, and she was admitted for intravenous hydration to correct her dehydration and help with her shortness of breath. Id. Her physical examination showed:

An elderly white female who was obviously short of breath on exam . . . Lungs had dry crackles throughout both lower lobes, half of lung fields bilaterally. Cardiovascular was distant; a systolic murmur heard previously was markedly diminished . . . Electrocardiogram showed a paced rhythm with appropriate sensing . . . Abdomen was benign, bowel sounds were present. Extremities had bilateral edema that was pitting, left was greater than right - this was to the upper calf bilaterally.

Id. In South County Hospital's nursing discharge summary, the RN who completed the form wrote:

[A]dmitted 6-11-00 [with shortness of breath and] difficulty [with] eating 4 - 5 days. Evaluation showed dehydration, CHF & hyperkalemia. Hx includes hypertrophic cardiomyopathy, paroxysmal A-fib, has duel pacer, COPD, CHF & mild pulmonary hypertension. Was recently discharged from rehab to home where she lived alone and was unable to care for herself. Is SOB [with] exertion, 02 dependent, bibasalar crackles and 1 - 2+ lower extremity edema. To your facility for ADLs, med management, cardio-pul assessment OT & PT.

CMS Ex. 3, at 5. A continuing care note stated, "Pt. referred to your facility for care. Pt. is alert/oriented but forgetful. Pt. requires assist [with] ADLs & med. mgt. Pt. skilled for daily RT." Id. A continuity of care form signed by Petitioner's physician, Jeffery Bandola, M.D., noted Resident 14's principal diagnoses on this admission as dehydration, COPD (oxygen dependent), obstructive cardiomyopathy, osteoarthritis, and high blood pressure, with active diagnoses prior to admission of a permanent pacemaker and paroxysmal atrial fibrillation. Id. at 6. The physician order treatment section of the form ordered PT five times a week and oxygen. Id.

Resident 14 was admitted to Petitioner's facility at 11:15 AM on June 15, 2000. CMS Ex. 4, at 1. Her initial nursing assessment at Petitioner's facility noted that she was oxygen dependent and that she had diagnoses of, among other things, CHF, dehydration, hyperkalemia, COPD, hypertrophic cardiomyopathy, and a pacemaker. Id. She was assessed to be alert and oriented, to use a walker and a wheelchair, to have upper torso weakness and an unsteady gate. Although her lungs were clear to auscultation, her breath sounds were diminished. Her shortness of breath was not acute. Her oxygen saturation was 92%. She had a Foley catheter draining clear yellow urine. Id. at 2. Her skin assessment noted dry skin and multiple scratches from her cats. Pitting edema was noted on both her lower legs, 2+ on the right and 3+ on the left. Id. at 3. She also had pressure sores. Id. Among her medications listed in the physician's orders was a prescription for Darvocet as needed for pain. Id. at 4.

The initial nurse's note, written at 12:10 PM on June 15, 2000, stated that

This is [Resident 14's] second admission to this facility. Diagnoses CHF Dehydration, Hyperkalemia, COPD, [oxygen] dependent, Hypertrophic Cardiom[yopathy], pacemaker, osteoarthritis, PAF, HTN . . . All orders copied from signed physicians interagency. Telephone call to SCH to inquire if dose of Lasix given this a.m. Nancy will return phone call to let us know if Lasix given and if K-tab given. Blue Chip skilled level of care to monitor cardiopulmonary status, therapy, ADLs, I&O, med management, ?dc planning. All departments notified of admission via voice mail. Note sent to administrative office. Insurer exemption received. Telephone call from . . . @SCH . . . . [p]t did not receive Lasix or K-tab. Initial nursing assessment and care plans started. VS 96.3 - 76 - 32 100/68. Placed on I&O [due to] dehydration. Has in-dwelling foley catheter . . . 75 cc clear yellow urine noted in . . . bag on admission. Last B.M. noted @ 06/12/00 on nurses interagency from SCH. Also, foley catheter changed 06/14/00 @ SCH. Pt. receiving p.o. antibi[otic] Cipro ? Diagnosis. Pt. did have [elevated] serum and urine wbcs @ SCH noted in admission packet. Pt. also had DPM consult by Dr. . . . [due to complaints of] pain in toes & feet. Per consult note Pt has venous stasis dermatitis. Diagnosis added to physician's order form. Pt also has small scabbed areas all over body. Pt. reports "They're from my cats. They use me as a scratch post." Skin dry. Fax sent to Dr. Bandola to address (1) ?Dermagan tx to open area (Stage 1.5 cm slit) @coccyx and red buttocks (2) Skin dry and itchy. Has scabbed areas all over body. ? Medicated cream (3) ? 1/3 side rails up both sides of bed to facilitate independent bed mobility . . . weakness & SOB [due to] deconditioning/hospitalization, CHF. (4) ? O.T. eval . . . (5) Need diet order. Dietary to serve NAS until clarified. Pt. was receiving NAS in hospital (6) ? lab orders (7) c/o "I feel constipated." ? Citrucel (per request) (8) remove foley. Pt. placed in bed from stretcher (ambulance) HOB [up arrow], O2 @2l/min by nasal cannula continuously. SpO2 on 02 2l/min 91 - 92%. Lungs clear to auscultation. Breath sounds diminished. Has bilateral lower leg and pedal pitting endema L > R. She denies acute respiratory distress.

CMS Ex. 5, at 2. Resident 14's baseline shows an individual with numerous medical problems. The question before me is whether, during the course of her stay at Petitioner's facility, Petitioner failed to notify her physician of specific significant changes from this baseline condition.

CMS asserts, expanding on the clinical issues cited in the 2567, that

Resident No. 14 had a myriad of signs and symptoms that were departures from her baseline, as established at the time she was admitted to Petitioner's facility. She varied from having clear lung sounds at the time of her admission, to having wheezing and the presence of crackles sounds at the lung bases. The quality of her breathing initially was diminished, but no acutely so, and later progressed to a point where she had rapid, shallow respirations, even while at rest, during one shift affecting ability to speak more than two words at a time, and during another shift, affecting her ability to tolerate solids. The pitting edema in her lower limbs fluctuated, both as to the assessed severity level (from relatively moderate at 2+ - 3+, to later, variously described as "nodule-like" and "gross" and "severe," and still later, reaching the top of the severity scale, at 4+, and as to affected body area (migrating from the feet area, to the thigh area down, and, ultimately, to the hip area down). Her skin color varied from not remarkable for overall color at the time of admission, to appearing at times "dusky," and "pale." Her urine underwent changes from clear and yellow at the time of admission, later becoming 'amber/cranberry colored," "tea-colored" and foul-smelling. She had onset of pain and discomfort complaints, having none at the time of admission, but later voicing complaints that her legs felt "like they weighed a ton," that her leg and back discomfort, required administration of an analgesic, and that she was tired and without strength. Her functional capacity for full eating independence shifted to the point where she was unable to self-feed, and could no longer take solids, even with assistance. She also had cognition and mood changes, moving from having been alert and fully oriented, with no confusion, and no signs of mood problems, to being disoriented and confused, with complaints of depression and inability to sleep.

CMS Br. at 21 - 22. CMS asserts that "these signs and symptoms represent departures from Resident No. 14's clinical baseline, as established at the start of care, and that they constitute significant changes related to her psycho-social, physical and health areas . . . and, further, that they thus give rise to a duty to consult with Resident No. 14's physician. With the exception of a telephone consultation on June 17, 2000, about Resident No. 14's shortness of breath and difficulty voiding complaints, Petitioner failed to timely consult with Resident No. 14's physician about these signs and symptoms." Id. at 22 - 23. ⁽⁸⁾

It is at this point that CMS's case falters when confronted with Petitioner's evidence. What CMS's case asks me to do is to lump all of Resident 14's symptoms together and infer either that somewhere in the Resident's fluctuating condition a "significant change" occurred, or to agree that all of these conditions taken and evaluated together constituted the "significant change." What CMS's case has failed to show me is any discrete tipping point at which a daily or hourly fluctuation in condition became "a significant change" requiring immediate notification of the resident's physician. The closest CMS's case can come to pointing out when such a moment occurred is when it uses terms such as "at the time of events" (CMS Br. at 19), on "multiple occasions" (Id. at 21), "over the course of these eight days" (Id.) or "during the eight days." Id. at 24. I contrast this with my finding in the case of Batavia Nursing and Convalescent Center, where I found specific instances of noncompliance, in that the petitioner had failed to apprise a physician of foul green drainage in a surgical wound or notify a physician of an incomplete x-ray over a period of days. Batavia Nursing and Convalescent Center, DAB CR1031, at 4 - 6 (2003), aff'd DAB No. 1904 (2004). Once Petitioner's evidence is considered, it is impossible to hold Petitioner responsible for alleged inaction over an eight-day period that, even now, and even with the benefit of hindsight, stubbornly resists yielding up a specific moment of "significant change."

When I evaluate Resident 14's baseline condition against the eight days she spent at Petitioner's facility to determine whether a significant change in her condition occurred, I see an elderly and chronically ill individual whose condition certainly fluctuated over time but did not significantly change from her baseline condition. I note that in this case the individuals who were most directly familiar with her clinical history and care while in Petitioner's facility, Dr. Bandola and Ms. McCall, have each expressed their opinions on the "significance" of the changes experienced by Resident 14. Dr. Bandola has stated that

I was [Resident 14's] treating physician at the time [of the survey]. Consequently, I am familiar with [Resident 14's] clinical condition, both before and during her stays at the facility. I have reviewed the facility's medical records regarding [Resident 14], and was in contact with their staff throughout [Resident 14's] stay at the facility. Based on my 21 years of experience as a primary care physician concentrating on treatment of the frail elderly and, in particular, nursing home residents, I feel that the facility's treatment of [Resident 14] was excellent, and certainly well within the standard of care for a nursing facility. It is my opinion that [Resident 14's] condition did not change in any significant way between the time she was admitted to the facility and when she was discharged to the hospital. Her symptomology during her stay at the facility was consistent with that which she had experienced prior to her admission. I received sufficient information from the staff of the facility during [Resident 14's] stay for me to make a judgment about [Resident 14's] care. I would not have needed any additional information from the facility to have made the medical decisions I did; and there would have been no other information in the possession of the facility which would have influenced me to order an alternative therapy or different course of care for [Resident 14]. In brief, [Resident 14's] condition was basically static during her time at the facility, the facility kept me sufficiently informed of [Resident 14's] condition, and the facility's staff could not have predicted the unfortunate death of [Resident 14] at the hospital.

P. Ex. 5. I rely on Dr. Bandola's opinion and Ms. McCall's testimony, read against the clinical record, in evaluating the variations noted in Resident 14's condition with regard to her symptoms and condition, which principally include: 1) shortness of breath and oxygen saturation; 2) edema; 3) pain and discomfort; 4) lung sounds; 5) mental and cognitive state; 6) vital signs; and 7) urinary tract issues. ⁽⁹⁾

Shortness of breath and oxygen saturation

Resident 14 experienced fluctuating shortness of breath while at South County Hospital. Her chief complaint upon entering the Hospital was "increasing shortness of breath" and she was found to be "obviously short of breath." CMS Ex. 3, at 1. On June 13, 2004, Resident 14's discharge summary noted her to be short of breath with exertion and oxygen dependent. Id. at 5. Resident 14 continued to experience fluctuating shortness of breath at Petitioner's facility. However, nursing notes reflecting her shortness of breath and oxygen saturation appear fairly constant and do not show that a significant change as defined above occurred. ⁽¹⁰⁾ Resident 14's oxygen saturation was to be maintained at 91 - 92%. My review shows that her oxygen saturation moved within a range of only a very few points of her initial assessment values and that the range downward is smaller than that upward. Moreover, when Resident 14 complained of shortness of breath, Dr. Bandola was contacted and prescribed medication for it.

CMS Ex. 5.

Edema

Upon her admission to South County Hospital on June 11, 2000, Resident 14 was found to have bilateral edema that was pitting, left leg greater than right leg, bilaterally to the upper calves. CMS Ex. 3, at 2. Her nursing discharge summary indicated that she had 1 - 2+ pitting edema. Id. at 5. Ms. Renzulli has testified that edema is a build-up of fluid in skin tissue where, if a thumb or a finger is pressed against the area it leaves a "dent" or a "pit" when removed. The depth of this pitting is scaled from 1 to 4 with a "+" mark after it; 1+ is a lesser amount and 4+ a greater amount of edema. The determination of the scale of edema is a subjective determination because it is dependent on the individual evaluating it. Tr. at 40 - 41. Ms. McCall testified that a resident's edema may change over the course of a day due to position. If the individual is sitting in a chair or walking around, as opposed to lying in bed, the individual's edema may get worse because gravity pulls the fluid into the tissues. Tr. at 105 - 106.

While Resident 14 was in South County Hospital, Dr. Bandola noted her edema to have increased. CMS. Ex. 3, at 3. The podiatrist treating Resident 14 recommended that she elevate her feet to help the edema and that she continue taking Lasix, a diuretic used to treat excess fluid retention. Id. at 4. Nurse's notes document the fluctuations in Resident 14's edema over the course of her stay in Petitioner's facility.

CMS Ex. 5. Although the extent of Resident 14's edema fluctuated during the time she was in the facility, she came to the facility with bilateral pitting edema, left leg greater than right, and she was sent to the hospital on June 22 with the same assessed condition. I note that the descriptions of Resident 14's leg and thigh edema in Petitioner's nurse's notes nowhere describe it as worsening, progressing, or spreading from the 3+ left, 2+ right documented on her admission. Nurse L. Howe, who saw Resident 14 very soon after her admission on June 15, made note of her edema then (CMS Ex. 5, at 2), also described the edema on the 3:00 to 11:00 shift on June 18, and described Resident 14's edema as "unchanged" during the 3:00 to 11:00 shift on June 20. This is a matter of significance: Nurse Howe's notes provide descriptions of the edema both made by the same trained, professional observer and co-extensive over time with most of the resident's eight-day stay in the facility. When Nurse Howe wrote "unchanged" on June 20, I understand her to mean that the edema was unchanged from her observations of it on June 15 and June 18. Id. at 6, 7. And, while CMS refers to Resident 14 having 4+ pitting edema (CMS Br. at 22), the only scaling to that degree took place in the hospital on June 22, not at Petitioner's facility. CMS Ex. 7, at 3.

Pain and Discomfort

CMS states that Resident 14 had onset of pain and discomfort complaints, none at the time of admission, and later complained that her legs felt like they weighed a ton and that her back and legs hurt requiring an analgesic, and that she was tired and without strength. CMS Br. at 22. I find that the only change noted here from her baseline was Resident 14's complaint that her legs "weigh a ton." Further, in the context of her care, this was not a significant change. It was a change that related to her edema, and it was evidently addressed with Lasix successfully, as it is not recorded that Resident 14 made the complaint again. See Tr. at 137; CMS Ex. 5, at 4. Moreover, Resident 14 had a history of periodic pain (apparently in her back) and she was prescribed Extra Strength Tylenol, and Darvocet, as needed, for pain, both at the hospital and with regard to the Darvocet at Petitioner's facility. P. Ex. 3, at 2, 35, 36; CMS Ex. 3, at 1, 6.

My review of the nurse's notes with regard to pain and discomfort shows that Resident 14's baseline was not significantly different from her condition during her stay at Petitioner's facility. ⁽¹¹⁾

CMS Ex. 5.

Lung sounds

When Resident 14 was admitted to South County Hospital her "[l]ungs had dry crackles throughout both lower lobes, half of both lung fields bilaterally." CMS Ex. 3, at 1. Her nursing discharge summary from the hospital notes "bibasalar crackles." Id. at 5. Ms. McCall testified that crackles could indicate fluid in Resident 14's lungs or, because of Resident 14's COPD, it could indicate the filling or lack thereof of the sacs in her lungs. Tr. at 106 - 107. Ms. McCall also testified that lung crackles come and go and that "[y]ou don't necessarily always hear them." Tr. at 123. It is also instructive to note that on this subjective clinical subject, as on the matter of edema, we have Nurse Howe's observations during the 3 - 11 shifts on June 15, 18, and 20. Here, as there, they represent another way of establishing a "baseline" based on the same trained observer's assessment of Resident 14 at similar times of day, and over almost the entire eight-day period. Nurse Howe recorded no significant changes.

CMS has not shown that the lung sounds exhibited by Resident 14 during her stay at Petitioner's facility were a significant change from her baseline, as reflected below. Moreover, there appears to be no obvious correlation between the recording of lung crackles and low oxygen saturation (see above) which leads me to believe that Resident 14 was not impaired beyond her already advanced COPD by the crackles, which appear to be part of Resident 14's normal COPD presentation.

CMS Ex. 5.

Mental and cognitive state:

CMS has asserted that Resident 14 had cognition and mood changes, moving from being fully alert and oriented with no confusion, to signs of mood problems, to being disoriented and confused, complaining of depression and inability to sleep. CMS Br. at 22. I find that the medical records show, as Petitioner asserts, that Resident 14's mental state remained within the parameters established by her baseline and did not significantly change. At South County Hospital, Resident 14 was assessed to be alert and oriented but "forgetful." CMS Ex. 3, at 5. Her condition did not change significantly at Petitioner's facility, as noted below. In fact, on the day before she left the facility for her assessment, June 21, Resident 14 was assessed by the nurse as alert and verbal with some confusion - essentially the same assessment she received upon her discharge from the hospital. Nurse Howe's notes on June 15, 18, and 20 corroborate this view, for the reasons I have explained above with reference to edema and lung sounds.

CMS Ex. 5

Vital signs

Resident 14's vital signs fluctuated over time but always returned to the values noted upon her initial assessment. Petitioner has submitted the record of Resident 14's temperature, pulse and respirations at the facility, and her blood pressures. I set them forth, below.

P. Ex. 3, at 11. Some of these vital signs were also noted in the nurse's notes. CMS Ex. 5.

Urinary condition

While the nurses' observations of Resident 14's urinary condition fluctuated over the course of her stay, at no time did a symptom persist that would indicate a significant change.

CMS Ex. 5. Although the condition of Resident 14's urinary output did fluctuate over the course of her stay, it does not appear that any of the changes necessitated an immediate consultation with her physician. Even when her urine appeared cranberry-colored on the morning of June 18, Petitioner's staff assessed it as likely to have been caused by Resident 14's pulling on the catheter, stated it would be monitored, and, by noon, the situation appeared to be resolving itself.

Other issues regarding Resident 14's condition

I note here that the nurses' notes indicate that Resident 14's appetite was not good. CMS Ex. 5. However, her poor appetite and intake was one of the reasons she was hospitalized at South County Hospital and thus does not appear to be a significant change from her baseline. Moreover, I note that her intake was not consistently poor. On June 21, the day before her death, the nurse's notes from the 11:00 - 7:00 shift note that she took fluids well (although during the 3:00 - 11:00 shift she took only 120 cc of coffee). CMS Ex. 5, at 7.

CMS also noted that Resident 14's skin color varied from not remarkable for overall color at the time of admission to appearing "dusky" or "pale." These are terms very much dependent on subjective opinions and I have not been shown how this notation of color, in the context of the other evidence, would indicate a significant change occurring in Resident 14's condition. Ms. McCall opined that the term "dusky" is used to describe the coloration of an individual with COPD or cardiac problems. Here, however, the term was used only twice over three days, both times by the same nurse, J. Martin, who assessed Resident 14's skin color as "dusky" once on June 16 during the 3:00 - 11:00 shift and once on June 19 during the 3:00 to 11:00 shift. CMS Ex. 5, at 3, 6. Her condition otherwise was about the same on each occasion. Id. No other staff member commented that Resident 14's skin was "dusky" and I agree with Petitioner that even if Resident 14's pallor changed it was not significant.

2. As I have found Petitioner in substantial compliance with participation requirements at all relevant times, CMS was not authorized to impose a CMP.

VI. Conclusion

For the reasons stated above, I find that, at all relevant times, Petitioner was in substantial compliance with participation requirements and that CMS's determination to impose the $1,000 per-instance CMP is unsupported by the evidence before me. No single one of, nor any combination of, the day-to-day alterations in Resident 14's physical and mental condition constituted the level of significant change contemplated by the regulations.

Richard J. Smith

Administrative Law Judge

1. Although the State survey agency found actual harm in connection with this deficiency, the scope and severity of the alleged noncompliance is not at issue. Transcript (Tr.) at 216 - 218; CMS's Post-hearing Brief at 2, n.2.

2. Although three other deficiencies were identified during the survey, none are disputed here. One was deleted during Informal Dispute Resolution and the other two were not considered as grounds for the CMP imposed. CMS's Post-hearing Brief at 1, n.1.

3. Petitioner and CMS have submitted copies of some of the same documents as exhibits. Where an exhibit is duplicated I refer to CMS's exhibits.

4. Moreover, even if the parties had discussed the second prong of the deficiency, I would not have found for CMS. The transfer was ordered by a physician, John W. Barrett, D.O., in order for the hospital to assess her clinical status after Resident 14 was transferred to Dr. Barrett's service, and the transfer was due to Dr. Barrett's inability to evaluate Resident 14 at Petitioner's facility. P. Ex. 3, at 1.

5. Petitioner communicated by FAX with Dr. Bandola during the week and by telephone when the doctor's office was closed and unable to receive a FAX. See Tr. at 121, 140.

6. Petitioner submitted Dr. Bandola's letter as P. Ex. 5 and Dr. Barrett's letter as P. Ex. 3, at 1. CMS did not object to my admitting either of these letters into evidence nor did it seek to cross-examine either Dr. Bandola or Dr. Barrett at the in-person hearing I held. I find the opinions of both physicians to be credible and persuasive when evaluated against the entire record.

7. The parties have provided definitions of some of these medical conditions, which I am summarizing in brief here. Chronic obstructive pulmonary disease (COPD) refers to a prolonged or persistent condition of respiratory dysfunction resulting in oxygenation or carbon dioxide elimination at a rate not sufficient to meet the demands of the body; congestive heart failure (CHF) is the inability of the heart to provide adequate pumping action of the blood through the heart chambers causing blood to back up into other areas of the body, including the extremities and/or the lungs, which can be caused by hypertension or cardiomyopathy (stiffening of the heart muscle); hypertrophic cardiomyopathy is a form of heart disease involving the enlargement of the heart muscle; ventricular hypertrophy is the thickening of the ventricular septum; hypertension refers to a persistent elevation of systolic and/or diastolic arterial pressure; and hyperkalemia refers to a condition caused by higher than normal levels of potassium in the blood. CMS Br. at 5 - 6, n. 4; P. Ex. 1, at 8 - 9.

8. CMS has also asserted that Petitioner was remiss by not contacting Dr. Bandola about a FAX that was apparently sent to Dr. Bandola on either June 18 (its date) or June 19 to which Dr. Bandola did not reply. CMS opines that it is possible that the FAX was not sent and also that, when the FAX was sent on June 21, the note from the nurse evidences the facility's failure to comply with the regulation. CMS Br. at 13. I disagree. The nurse's notes show that the document was FAX'd to Dr. Bandola on June 19 and that it was sent again on June 21 due to a friend of Resident 14's concerns that the doctor had not seen Resident 14. Although it requests in the addendum dated 6/21 that Resident 14 be seen "ASAP," it does not reflect what I consider a significant change in the conditions that Resident 14 was experiencing. CMS Ex. 4, at 6. And, the next day, Resident 14 was sent to the hospital for assessment by a new physician.

9. I also rely on the opinion of Dr. Barrett, who asserts, after reviewing the nurse's notes, that "Nursing notes clearly reflect the patients' poor baseline clinical status, but also document her apparent stability without evidence for significant deterioration, i.e. no complaints, denies discomfort, resting comfortably, and adequate oxygen saturations. CMS Ex. 3, at 1.

10. Petitioner has defined oxygen saturation to indicate the percentage of hemoglobin saturated with oxygen. When levels drop below 70%, tissues do not receive sufficient oxygen to function. P. Br. at 27, n. 15. CMS has not contested this definition.

11. I am not addressing Resident 14's assessment of itchy skin or scabbed areas from cat scratches. The facility was treating these conditions with a medicated cream. See CMS Ex. 5, at 1.