SUBJECT:

Britthaven of Raleigh,

Petitioner,

Centers for Medicare & Medicaid Services

DECISION

I decide that Petitioner, Britthaven of Raleigh, did not prove by a preponderance of the evidence that, on October 30, 2001 and thereafter, it was complying substantially with federal requirements governing its participation in the Medicare program. Consequently, I sustain the determination of the Centers for Medicare & Medicaid Services (CMS) to terminate Petitioner's participation in Medicare effective November 1, 2001.

I. Background

Petitioner is a long-term care facility that is located in Raleigh, North Carolina. Prior to November 1, 2001, it participated in the Medicare program. Its participation in Medicare was governed by federal regulations at 42 C.F.R. Part 483, which apply to the participation of skilled nursing facilities and nursing facilities in Medicare and State Medicaid programs.

On October 30, 2001, Petitioner was surveyed by representatives of the North Carolina Department of Health and Human Services Division of Facility Services (North Carolina State survey agency). A purpose of the survey was to determine whether Petitioner was complying substantially with federal participation requirements. The surveyors concluded that Petitioner was not complying substantially with the requirement that is stated at 42 C.F.R. � 483.25(a)(3), which provides that:

A resident who is unable to carry out activities of daily living receives the necessary services to maintain good nutrition, grooming, and personal and oral hygiene.

CMS accepted the North Carolina State survey agency's finding of noncompliance and determined to terminate Petitioner's participation in Medicare effective November 1, 2001. Petitioner requested a hearing and the case was assigned to me for a hearing and a decision.

I decided to expedite the hearing in this case in light of CMS's determination to terminate Petitioner's participation in Medicare. I held a hearing in Raleigh, North Carolina on January 24, 2002. I heard the testimony of witnesses called by the parties. I received into evidence exhibits offered by CMS consisting of CMS Exhibits (CMS Exs.) 1-3; CMS Exs. 29-41; CMS Exs. 43-50; CMS Ex. 53; CMS Ex. 63; and CMS Exs. 65-68. I received into evidence exhibits offered by Petitioner consisting of Petitioner Exhibits (P. Exs.) 1-32.

II. Issue, findings of fact and conclusions of law

A. Issue

The issue in this case is whether, on October 30, 2001 and thereafter, Petitioner failed to comply substantially with a federal participation requirement, thereby giving CMS authority to terminate Petitioner's participation in Medicare. More specifically, the issue in this case is whether, on October 30, 2001 and thereafter, Petitioner was complying substantially with the participation requirement that is stated at 42 C.F.R. � 483.25(a)(3). The surveyors who conducted the October 30, 2001 survey concluded, and CMS now alleges, that Petitioner was not complying with this requirement in that Petitioner allegedly did not provide timely incontinence care for five of 11 sampled residents who were assessed as being dependent on facility staff for incontinence care. CMS Ex. 29, at 1-11.

CMS argues that 42 C.F.R. � 483.25(a)(3) incorporates a standard of care governing the frequency with which a facility's staff should check and, if necessary, provide incontinence care for incontinent residents. It avers that the standard requires incontinent residents be given the necessary care frequently or about every two hours. It alleges that Petitioner did not comply with this standard because its staff allowed each of the residents whose care is at issue to be unattended for periods of between three and five hours between incontinence checks. CMS Ex. 29, at 1-11. CMS contends that these residents suffered at least the potential for more than minimal harm.

Petitioner denies these allegations. First, it contends that the surveyor's observations, which are the basis for the allegations, are not credible and are without merit. Second, it asserts affirmatively that it gave its residents care that met any reasonable standard of incontinence care, including the standard asserted by CMS.

B. Findings of fact and conclusions of law

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

1. The applicable standard of care for a long term care facility is to check and, if necessary, change its incontinent residents frequently, or about once every two hours. This standard of care is subsumed within the requirements of 42 C.F.R. � 483.25(a)(3).

The requirement of 42 C.F.R. � 483.25(a)(3) that a facility must provide "necessary services" to residents to maintain personal hygiene subsumes professionally-recognized standards of care for such services. These standards are not enumerated specifically in the regulation. However, 42 C.F.R. � 483.25(a)(3) would be meaningless if it were left entirely to the discretion of a facility to decide how it would provide services to its residents. Thus, a facility must adhere to professionally-recognized standards of care in providing care to its residents.

An "incontinent" resident is an individual who has no control over his or her bowel or bladder functions and who is incapable of being trained to use bathroom facilities. The professionally-recognized standard of care for attending to an incontinent resident is that the resident should be checked for incontinence frequently, or at about two hour intervals. If a resident is found to be incontinent, that resident should be given the necessary incontinence care and his or her garments or bed linens should be changed. This is not a rigid standard that a facility must follow with mechanical precision. But, it is a reasonable yardstick by which a facility's performance in providing incontinence care may be measured. Failure by a facility to adhere reasonably to the standard is grounds for concluding that the facility is not providing its residents with adequate incontinence care.

I base my conclusion in part on the persuasive testimony of Joseph Ouslander, M.D., an expert physician called to testify by CMS. Transcript (Tr.), at 54-97. Dr. Ouslander is expert in providing guidance to long term care facilities about incontinence care. Dr. Ouslander has extensive experience dealing with long term care facilities and their staffs. Tr., at 64.

Dr. Ouslander averred that residents who are incapable of remaining continent should be checked and, if necessary, cared for about every two hours. Tr. at 62. This standard is stated in numerous textbooks and articles, including Dr. Ouslander's own textbook, and is, therefore, a recognized and widely accepted standard of care. Id. at 82. Failure to adhere to the standard could have serious adverse effects for incontinent individuals. Potential adverse consequences of failing to provide adequate incontinence care include: physical discomfort; agitation and behavioral disturbance; skin breakdown and pressure ulcers; urinary tract infection; and, falls related to efforts to use the bathroom. Id. at 63 - 67.

Another way of expressing the standard is to say that incontinent residents must be checked and, if necessary, provided incontinence care frequently. Dr. Ouslander did not contend that a two-hour check standard for incontinence care was one that had to be adhered to rigidly by a facility. Tr. at 94-95. Indeed, the standard was deliberately not stated as an explicit guideline for long term care facilities because the drafters of such guidelines did not want surveyors to apply the standard rigidly. Id. Whether the standard is expressed in terms of a quantitative measurement of frequency of care or not, the point is that incontinent residents of a long term care facility must be checked and given care often enough so as to avoid the adverse consequences that result from sitting or lying in urine or feces.

In its post-hearing brief, Petitioner argued that Dr. Ouslander conceded that neither the Agency for Health Care Policy Research guidelines on urinary incontinence in adults nor the National Practice Guideline for nursing home care state specific time check requirements for incontinence care. Although that is true, it does not detract from my conclusion that there is a flexible requirement that incontinent residents be checked and changed frequently or about every two hours. As Dr. Ouslander averred, the standard is a flexible standard and not a rigid one, and putting it into guidelines as a requirement that must be met mechanically by a facility might have inappropriate consequences. Tr. at 94.

Petitioner has not offered expert testimony or other evidence to establish that Dr. Ouslander's opinion is incorrect, or that it is contrary to the weight of professional opinion. Nor did Petitioner aver that some standard other than that which Dr. Ouslander asserted is the governing standard for incontinence care. Indeed, Petitioner's own policy was to adhere to a standard of care that is essentially the same as that which Dr. Ouslander stated to be the recognized standard of care. Petitioner's policy provides that:

Individuals should be checked frequently, (i.e., q 2 hours, or before meals, mid-morning, mid-afternoon, and before bed), cleaned thoroughly with a pH balanced cleanser, and have an appropriate barrier and brief applied.

CMS Ex. 39, at 7.

2. CMS established a prima facie case that Petitioner failed to provide incontinence care to its residents in a manner that is consistent with the professionally-recognized standard.

The surveyors who conducted the October 30, 2001 survey of Petitioner found that Petitioner failed to provide incontinence care to residents identified in the survey report as Resident Nos. 5, 6, 7, 8, and 9 for periods ranging from about three hours to about five hours. CMS Ex. 29, at 1-11. Each of these residents is an individual who is described in treatment records maintained by Petitioner as being totally dependent on Petitioner's staff for incontinence care. Id. at 1, 4, 5-6, 7, 9.

The surveyor who is the primary source for these allegations is Joyce Berlin, R.N. Tr., at 97-162. The allegations in the survey report are based primarily on Ms. Berlin's recorded observations. CMS Exs. 34-37; CMS Ex. 39. CMS supported these observations with Ms. Berlin's testimony at the hearing.

If Ms. Berlin's observations and testimony are credible, they are a basis for finding that Petitioner failed to provide continence care to each of the five residents that she observed for periods ranging from about three hours to about five hours. If credible, Ms. Berlin's testimony and recorded observations are prima facie evidence that Petitioner failed to comply with the professionally-recognized standards - and Petitioner's own internal policy - for providing care to incontinent residents.

I find Ms. Berlin's testimony and observations to be credible. For that reason, I conclude that CMS established a prima facie case that Petitioner failed to provide incontinence care to its residents in a manner that was consistent with the professionally-recognized standard.

On October 30, 2001, Ms. Berlin arrived at Petitioner's facility before 6:00 a.m. Tr. at 99, 100. She was assigned the responsibility of observing the incontinence care that Petitioner's staff gave to the five residents whose care is at issue here. Id. at 101-102. As of the date of the survey these residents lived in rooms situated along a hallway of Petitioner's facility known as the "Blue Hall." CMS Ex. 66. The Blue Hall is an "L" shaped corridor. Id. Two of the residents that Ms. Berlin observed, Residents Nos. 7 and 9, resided in Room 105. Tr. at 114-115. Two other residents, Residents Nos. 5 and 8, lived in Room 107, which adjoins room 105. Id. at 107, 116; CMS Ex. 66. The fifth resident, Resident No. 6, resided in Room 111. Tr. at 116-117. Rooms 105 and 107 are located along the long axis of the "L" that comprises the Blue Hall. CMS Ex. 66. Room 111 is located along the short axis of the "L". Id. Rooms 105, 107, and 111 all face into the Blue Hall from the same side of the corridor; that side being the side on which odd-numbered rooms are located. Id. All three rooms are situated close to the junction of the two axes of the Blue Hall. Id.

Ms. Berlin positioned herself near the junction of the two axes of the Blue Hall in order to be able to observe simultaneously the entrance and departure of Petitioner's staff from Rooms 105, 107, and 111. Tr. at 103. She spent the majority of her time during the survey at that location. Id. at 104. She testified that, from that vantage point, she had a clear view of the three rooms that she observed. Id.

Ms. Berlin's specific observations are stated in the survey report and in the notes she made during the survey. CMS Ex. 29; CMS Exs. 34-37; CMS Ex. 39. Ms. Berlin averred that she observed the comings and goings from Resident No. 5's room on October 30, 2001 from 6:00 a.m. until after 11:00 a.m. During this time, she saw no incontinence care being given to the resident. At 11:00 a.m., she asked the staff to check the resident for incontinence. The resident's incontinence brief was found to be saturated with urine. CMS Ex. 29, at 1-3. Ms. Berlin reported that she observed the care being given to Resident No. 8 starting at 6:05 a.m. on October 30, 2001. She made continuous observations of the resident beginning at 6:30 a.m. on that date. She observed no interventions between Petitioner's staff and the resident from about 7:20 a.m. until after 11:40 a.m. At that time, Ms. Berlin detected an odor of urine upon approaching the resident's bed. Petitioner's staff removed the resident's incontinence brief and it was found to be saturated with urine. Id., at 4-5.

Ms. Berlin asserted that she saw Resident No. 7 receive incontinence care at 6:15 a.m. on October 30, 2001. She then observed the resident continuously beginning at 6:30 a.m. on that date. She saw no incontinence care being provided to the resident until 9:55 a.m. At that time a person on Petitioner's staff removed the resident's brief and it was found to be saturated with urine. CMS Ex. 29, at 5-6. Ms. Berlin averred that she saw Resident No. 9 receive incontinence care at 6:18 a.m. on October 30, 2001. She observed no incontinence care being given to the resident between 6:18 a.m. and 9:15 a.m. At that time, she observed a nursing aide remove the resident's incontinence brief. The brief was saturated with urine. Id. at 7-8.

Ms. Berlin averred that she observed the care being given to Resident No. 6 continuously from 6:25 a.m. until 10:44 a.m. on October 30, 2001. She saw the resident being given incontinence care at about 7:25 a.m. although, according to Ms. Berlin, the resident's buttocks and perineal area were not dried after being washed and the nurse's aide failed to apply a barrier cream at that time. CMS Ex. 29, at 10-11. According to Ms. Berlin, at about 8:00 a.m. an odor of feces was noted to be present in the resident's room. Ms. Berlin asserted that shortly thereafter, a member of the resident's staff picked up a meal tray from the resident's room but made no other interventions at that time. No further incontinence care was given to the resident until 10:44 a.m. At that time, the resident was found to be soiled with both urine and feces.

Petitioner asserts that Ms. Berlin's testimony is not credible because Ms. Berlin could not possibly have observed simultaneously the care that Petitioner's staff gave to all five of the residents whose care is at issue here. Petitioner argues that Ms. Berlin could not have observed all five of the residents simultaneously due to their residence in different rooms, and due also to the location of their rooms on different axes of the Blue Hall. And, it contends that Ms. Berlin would not have been in any position to know what care Petitioner's staff was giving residents other than the resident whose care Ms. Berlin was observing directly at any given moment. Thus, for example, it is conceivable that Petitioner's staff might have provided incontinence care to Resident No. 6 while Ms. Berlin was observing the care that the staff gave to Resident No. 5.

Petitioner is correct in asserting that there would have been moments when Ms. Berlin would have not been able to see who was entering or leaving a particular room. If Ms. Berlin turned her head to the left, as she was standing at the junction of the two axes of the Blue Hall, she would not have had a clear view of what was going on to her right.

And, she would not have been able to observe activity to her left when she turned her head to her right. Furthermore, Petitioner certainly is correct in contending that Ms. Berlin could not have seen activity occurring in a resident's room other than a room that she was in while she was observing the care that was being provided in that particular room.

But, these undeniably true contentions do not detract significantly from the overall credibility of Ms. Berlin's testimony and recorded observations. The fact that Ms. Berlin's view of one or two residents' rooms might have been obscured for a few seconds as she turned her head from side to side to watch other rooms does not detract at all from her testimony and observations. Conceivably, an aide could have dashed into a room and left while Ms. Berlin's head was turned for a few seconds or even a minute or two. But, incontinence care was not performed by aides who dashed into and out of rooms. The care that was performed on each of the residents in question - when it was performed - consisted of removing and discarding the soiled incontinence brief and, perhaps bed linens as well, cleaning the resident, drying the resident, applying barrier cream to the resident's buttocks and perineal area, and re-dressing the resident with a fresh incontinence brief. Such actions did not transpire in an instant. Even a simple check of a resident which ascertained that the resident was dry would have had to involve positioning the resident, removing the resident's brief, and then, replacing the brief on the resident's body. Ms. Berlin would not have failed to observe the comings and goings of nursing aides which accompanied such care because her attention may have been diverted momentarily as she turned her head to view a particular axis of the Blue Hall.

Moreover, two of the three rooms that Ms. Berlin observed were adjacent to each other on one axis of the Blue Hall and the third room was only a few feet down the other axis. CMS Ex. 66. Ms. Berlin was in close proximity to all three rooms as she stood at the junction of the axes of the Blue Hall and I am unconvinced that she would have missed any significant activity when she turned her head from side to side to look at particular rooms. See Id.

Nor am I persuaded that Ms. Berlin would have omitted to observe at least part of an episode of incontinence care that was transpiring in a room other than a room that she was observing directly. None of the observations that Ms. Berlin made of the care that was provided to the residents in question required her to be in any resident's room for more than a few minutes. Obviously, Ms. Berlin might have missed some aspects of care given to a resident in another room - assuming that such care was provided - while she was observing the care that was being given in a particular room. But, it is highly unlikely, in my judgment, that she would have missed seeing all of that care. Thus, Ms. Berlin could have missed the beginning or end of incontinence care that Petitioner's staff gave to a resident while she was observing care being given to another resident. I find it unlikely, however, that her involvement with one resident would have precluded her entirely from seeing or being aware of any aspect of the care being provided to another resident, assuming that the care actually was provided.

Petitioner asserts that Ms. Berlin's recorded observations contain discrepancies and inaccuracies that undermine her testimony and render her findings not credible. I have looked at Ms. Berlin's observations and I find that any inaccuracies or discrepancies alleged by Petitioner are trivial and do not detract from the overall credibility of Ms. Berlin's findings.

There is much dispute between the parties as to the significance of Ms. Berlin's observations that all five of the residents in question were found to have been incontinent when incontinence care finally was provided to them. CMS asserts that these episodes of incontinence provide evidence - in addition to Ms. Berlin's direct observations of the lengths of time that the residents were allowed to go without receiving incontinence care - that Petitioner failed to provide incontinence care timely to its residents. Petitioner argues that the fact that all five of the residents had been incontinent is essentially meaningless because there is no evidence to establish when the incontinence episodes occurred.

I do not find evidence, that all of the five residents in question had been incontinent, to be significant proof that Petitioner failed to provide them with timely incontinence care. Rather, I base my finding that CMS established a prima facie case that Petitioner did not comply with professionally-recognized standards of incontinence care on Ms. Berlin's observations of the length of time that transpired between incontinence checks and care for each of the five residents. By definition, an incontinent resident will be incontinent, probably several times a day. For that reason, the fact that a resident was incontinent at some point between incontinence checks is not meaningful. On the other hand, the whole point of requiring frequent incontinence checks of incontinent residents is to minimize the amount of time that these residents are exposed to their urine and feces. So, what is meaningful here is that there is prima facie evidence that residents were allowed to wait for long periods of time between incontinence checks and not necessarily that they were found to have been incontinent when they were finally checked.

CMS also attempted to argue at the hearing that Petitioner had been cited on previous occasions for failure to provide timely incontinence care to its residents. From this, CMS wanted me to infer that Ms. Berlin's observations on October 30, 2001 were added proof of a long-standing failure by Petitioner and its staff to provide timely incontinence care to its residents.

I am not basing my finding that CMS established a prima facie case against Petitioner of noncompliance with applicable standards of incontinence care on Petitioner's past compliance history. The issue before me in this case relates solely to Petitioner's compliance status as of October 30, 2001. Petitioner's past compliance history would be no basis for finding Petitioner to be noncompliant as of October 30, 2001 had Petitioner been following professionally-recognized standards of care on that date. And, if Petitioner was not following professionally-recognized standards of care on October 30, 2001 - as is indicated by CMS's prima facie evidence of Petitioner's noncompliance - then Petitioner was noncompliant with those standards regardless of its previous compliance history.

3. CMS established a prima facie case that Petitioner failed to comply substantially with the requirements of 42 C.F.R. � 483.25(a)(3).

As I discuss at Finding 2, CMS offered prima facie proof that Petitioner failed to comply with a professionally-recognized standard of care that is implicit in 42 C.F.R. � 483.25(a)(3). That evidence, coupled with evidence that Petitioner's compliance failure posed a potential for more than minimal harm to residents of Petitioner, is sufficient to establish a prima facie case that Petitioner failed to comply substantially with the requirements of the regulation.

The evidence of a potential for more than minimal harm was supplied by Dr. Ouslander. As I discuss at Finding 1, the failure by a facility to provide timely incontinence care to its residents poses a potential of both psychological and physical harm to residents. Such potential harm includes agitation and discomfort, skin breakdown and pressure ulcers, infections, and falls.

4. Petitioner did not prove by a preponderance of the evidence that it complied substantially with the requirements of 42 C.F.R. � 483.25(a)(3).

Petitioner relies on two lines of proof to contend that the preponderance of the evidence shows that it complied substantially with the requirements of 42 C.F.R. � 483.25(a)(3). First, Petitioner offers the statements of several nursing assistants for the purpose of proving that the five residents whose care is at issue received timely incontinence care on October 30, 2001. Second, Petitioner offers proof to show that these residents did not suffer from pressure sores or other skin problems. It asks that I infer from the absence of pressure sores or skin problems involving the residents that these residents received timely incontinence care.

I find that Petitioner did not prove, by a preponderance of the evidence, that Petitioner was complying with the regulation. At best, the evidence that Petitioner relies on establishes a case for compliance that is equally as strong as CMS's prima facie case for noncompliance. Even giving the maximum weight to Petitioner's evidence, it does not establish by a preponderance of the evidence that Petitioner was providing incontinence care to its residents that comported with professionally-recognized standards. But in addition, there are some problems with Petitioner's evidence which renders it less than compelling and less persuasive overall than the evidence that was offered by CMS.

a. The unsworn statements of Petitioner's former employees.

I received into evidence from Petitioner signed and witnessed, but unsworn, statements from five of its former employees. P. Exs. 26-30. These statements contradict in some respects Ms. Berlin's testimony and recorded observations. In her statement, Ms. Lorraine Boyd avers that she provided incontinence care to Resident No. 6 between 8:30 a.m. and 8:35 a.m. on October 30, 2001, contradicting Ms. Berlin's assertion that the resident did not receive such care on that date between about 7:25 a.m. and 10:44 a.m. P. Ex. 26; see CMS Ex. 29, at 10-11. Ms. Dana Edgerton avers in her statement that, at some points in time after 7:20 a.m. on October 30, 2001, she provided incontinence care to the residents in Room 105 of Petitioner's facility (Residents Nos. 7 and 9) and to the residents in Room 107 (Residents Nos. 5 and 8). P. Ex. 27. Arguably, her contentions contradict Ms. Berlin's testimony and observations that, on October 30, 2001: Resident No. 5 did not receive any incontinence care between 6:00 a.m. and 11:00 a.m.; Resident No. 8 did not receive any incontinence care between 7:20 a.m. and 11:40 a.m.; Resident No. 7 did not receive any incontinence care between 6:30 a.m. and 9:55 a.m.; and, Resident No. 9 did not receive any incontinence care between 6:15 a.m. and 9:15 a.m. See CMS Ex. 29, at 1-3, 4-5, 5-6, 7-8.

In his statement, Mr. Nurdean James avers that, on October 30, 2001, he provided incontinence care to Residents Nos. 5 and 8 at about 9:15 a.m. P. Ex. 30. This statement contradicts Ms. Berlin's observation that these two residents did not receive such care before 11:00 a.m. and 11:40 a.m., respectively.

In one of two statements submitted by her, Ms. Michelle Dismuke avers that she saw Ms. Berlin enter Room 110 of Petitioner's facility at about 7:25 a.m. on October 30, 2001 in order to observe the care that a resident was receiving at that time. Ms. Dismuke avers that she did not see Ms. Berlin "back onto the unit for approximately 10 minutes", thereby suggesting that there was a 10 minute interruption in Ms. Berlin's observations of the residents' rooms beginning at about 7:25 a.m. on October 30, 2001. P. Ex. 29. This statement might contradict Ms. Berlin's assertion that she observed the residents' rooms for incontinence care continuously beginning about 6:30 a.m. on October 30, 2001.

Even if I were to accept these statements as fully credible, they would not overcome the prima facie evidence presented through Ms. Berlin's testimony and recorded observations. Petitioner has the burden of proof here. There is nothing about these statements that would give them greater probative value than the evidence elicited from Ms. Berlin.

These statements also have some significant credibility problems. None of them were made under oath. They consist of unsworn hearsay. Inherently, they have less probative value than Ms. Berlin's sworn testimony.

CMS argues that the statements should be afforded little or no probative value because Petitioner did not produce their authors at the hearing so that counsel for CMS could cross-examine these individuals. Although I find that the statements have less probative value than does Ms. Berlin's testimony, I emphasize that I do not find the statements' probative value to be reduced because the authors of the statements were not present at the hearing. CMS's counsel could have subpoenaed these individuals if she wanted to cross-examine them. It is the fact that the statements were not made under oath that makes them inherently less reliable than those statements that are made under oath. Had these statements been made under oath I would have afforded them the same probative value that I normally assign to direct testimony that is made under oath whether or not Petitioner produced the statements' authors at the hearing.

Moreover, the statements are not nearly so precise as is Ms. Berlin's chronology of the events of October 30, 2001. Their imprecision further reduces their credibility, especially when they are contrasted with Ms. Berlin's testimony and recorded observations. For example, in her statement, Ms. Edgerton contends that, on October 30, 2001, she gave incontinence care to four of the residents whose care is at issue (Residents Nos. 5, 7, 8, and 9) after 7:20 a.m. But, she does not identify the precise times when she allegedly gave such care. That omission renders her statement vague and diminishes its probative value. Moreover, Ms. Edgerton's failure to pinpoint the times when she provided incontinence care raises the possibility that the statement is not, in reality, inconsistent with anything that Ms. Berlin said.

Similarly, Ms. Dismuke's statement that she "did not see" Ms. Berlin return to the unit (by "unit" I presume that Ms. Dismuke means the Blue Hall) for about 10 minutes after seeing her enter Room 110 at about 7:25 a.m. on October 30, 2001 in order to observe care in that room, is ambiguous and of little probative value. See P. Ex. 27. Ms. Dismuke does not explain where she was during that 10 minute period. For that reason, it is impossible to tell from her statement whether Ms. Dismuke was in any position to know how long Ms. Berlin remained in Room 110.

b. Evidence relating to the condition of the residents' skin.

Petitioner avers that, with one exception, none of the residents whose care is at issue manifested any skin problems on October 30, 2001. There were no pressure ulcers on the residents' buttocks or perineal areas and only one case of redness or skin irritation. Petitioner avers also that none of these residents showed any history of skin irritation or sores resulting from poor incontinence care. From these assertions Petitioner argues that it must not have been providing poor incontinence care to the residents.

Although I do not take issue with Petitioner's assertions concerning the condition of the residents' skin, I do not find that the evidence offered by Petitioner proves that it was providing adequate incontinence care to its residents. The fact that the residents whose care is at issue did not, for the most part, manifest skin problems does not prove that they were receiving acceptable incontinence care. Pressure ulcers and skin irritation are possible consequences of inadequate incontinence care. However, there is no evidence to show that they are inevitable consequences of inadequate incontinence care.

Both the North Carolina State survey agency and CMS recognized this distinction in making assessments of the scope and severity of Petitioner's failure to comply with the requirements of 42 C.F.R. � 483.25(a)(3). It is not alleged in this case that Petitioner's noncompliance caused the residents to experience actual harm. The assertion is that the noncompliance created a potential for more than minimal harm to the residents. As I discuss above, at Findings 1 and 3, the prima facie evidence in this case is that Petitioner's failure to provide timely incontinence care to its residents created a potential for more than minimal harm to these individuals. Petitioner's evidence does not rebut that prima facie evidence.

5. CMS is authorized to terminate Petitioner's participation in Medicare as a consequence of Petitioner's failure to comply substantially with the requirements of 42 C.F.R. � 483.25(a)(3).

CMS is authorized to terminate the participation in Medicare of a health care provider, including a long term care facility, that fails to comply substantially with one or more federal participation requirements. Social Security Act (Act), section 1866(b)(2)(A). CMS is authorized to terminate Petitioner's participation in Medicare effective November 1, 2001 based on its failure as of October 30, 2001 to comply with the requirements of 42 C.F.R. � 498.25(a)(3).

Steven T. Kessel

Administrative Law Judge