SUBJECT:

Beechwood Sanitarium,

Petitioner,

Centers for Medicare & Medicaid Services.

DECISION

I sustain the determinations of the Center for Medicare & Medicaid Services (CMS, formerly known as the Health Care Financing Administration, or HCFA) to impose remedies against Petitioner, Beechwood Sanitarium, consisting of the following:

• Termination of Petitioner's participation in the Medicare program effective June 17, 1999; and

• Denial of payment for new Medicare admissions, effective with Petitioner's receipt of a notice from CMS dated May 21, 1999, in which CMS informed Petitioner of its determination to impose this remedy.

I. Background

Petitioner is a long term care facility located in Rochester, New York. Petitioner participated in Medicare and in the New York State Medicaid program. Its participation in these programs was governed by relevant sections of the Social Security Act (Act) and by participation requirements that are stated at 42 C.F.R. Part 483.

Petitioner was surveyed on several occasions in 1999 by surveyors employed by the New York State Department of Health, Division of Health Care Standards and Surveillance (New York State survey agency) in order to determine Petitioner's compliance with federal participation requirements. The 1999 surveys included surveys that were completed on the following dates: April 22, 1999 (April 1999 survey); May 12, 1999 (May 1999 survey); and, June 14, 1999 (June 1999 survey). At each of these surveys, the surveyors concluded that Petitioner was not complying substantially with federal participation requirements. CMS concurred with these determinations and imposed remedies against Petitioner consisting of denial of payment for new Medicare admissions and termination of Petitioner's participation in the Medicare program.

Petitioner requested a hearing and the case was assigned to me for a hearing and a decision. I held a hearing which included receiving testimony by telephone on April 3, 2001 and in person in Rochester, New York on April 17, 2001. At these sessions, I heard the testimony of several witnesses either by telephone or in person. I also received exhibits from the parties. I received into evidence exhibits from CMS which are identified as HCFA Ex. 1 - HCFA Ex. 9 and HCFA Ex. 12 - HCFA Ex. 47. I received into evidence exhibits from Petitioner which are identified as P. Ex. 1 - P. Ex. 33 and P. Ex. 35 - 51.

Many of the exhibits that each party offered consist of transcript excerpts from a New York State hearing (State licensing hearing) concerning Petitioner's license to operate a long term care facility in that State. The State licensing hearing involved extensive testimony by numerous witnesses. The parties to this case advised me that the transcript of that hearing is approximately 3000 pages in length. Initially, they requested that I receive the entire State licensing hearing transcript into evidence. I denied that request on the ground that it would be too cumbersome to do so. As an alternative to the parties' request, I allowed them to offer excerpts from the State licensing hearing transcript into evidence. I directed that each party identify any excerpt that it wished to offer as an exhibit. The transcript excerpts that the parties offered are in evidence as part of the "HCFA" exhibits and as part of the "P." exhibits.

Additionally, I received into evidence exhibits from Petitioner which are identified by the letter "M." These exhibits were previously identified and offered as evidence at the State licensing hearing involving Petitioner's license as a nursing facility in the State of New York. Each "M" exhibit also has a unique identifying number as in, for example, M1818. As a courtesy to Petitioner, I permitted it to offer "M" exhibits into evidence without re-identifying them. The "M" exhibits that I admitted into evidence are recited in an exhibit list submitted by Petitioner on July 16, 2001. Petitioner's (Beechwood) Exhibit List, Revised 7/16/01.

II. Issues, findings of fact and conclusions of law

A. Issue

The issue in this case is whether CMS is authorized to impose remedies against Petitioner including termination of Petitioner's participation in the Medicare program and denial of payment for new Medicare admissions.

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 separately numbered heading. I discuss each Finding in detail.

CMS must establish a prima facie case that Petitioner failed to comply substantially with one or more participation requirements in order to establish a basis to impose a remedy. If CMS does so, then the burden falls on Petitioner to rebut that prima facie case by the preponderance of the evidence. Hillman Rehabilitation Center, DAB No. 1611 (1997), aff'd, Hillman rehabilitation Center v. HHS, No. 98-3789 (GEV), slip op. at 25 (D.N.J. May 13, 1999). I have applied the Hillman standard to both the issue of whether CMS was authorized to terminate Petitioner's participation effective June 17, 1999 and whether CMS was authorized to deny Petitioner payment for new Medicare admissions in May 1999.

1. I incorporate into this decision rulings dated September 5, 2000 that address legal issues.

Prior to the hearing of this case, CMS moved for partial summary disposition as to certain issues of law. On September 5, 2000, I issued rulings which partially granted CMS's motion. Rulings on Motion by Health Care Financing Administration for Partial Summary Disposition, September 5, 2000 (Rulings). It is unnecessary for me to revisit those rulings here in detail. Rather, I am incorporating them into my decision. Briefly summarized, the rulings that granted CMS's motion in part are as follows:

• I do not have authority to hear and decide Petitioner's challenges of actions taken against it by the New York State survey agency. Rulings at 2 - 3.

• I do not have the authority to hear and decide challenges from Petitioner of the constitutionality of actions taken by the State of New York or by CMS. Rulings at 3.

• CMS is not required by law to use "reasonable time frames" to evaluate a facility's performance before terminating that facility's participation in Medicare based on the facility's noncompliance with federal participation requirements. Rulings at 4.

• CMS's determinations in this case are not invalidated by any irregularities that may exist in notices that CMS issued to Petitioner or to the public. Rulings at 4 - 7.

2. I dismiss Petitioner's hearing request insofar as it addresses findings that were made at the April 1999 survey because there is no issue arising from that survey that I have the authority to hear and decide.

I dismiss Petitioner's hearing request insofar as it challenges findings of noncompliance that were made at the April 1999 survey. Dismissal of a hearing request is appropriate where a party has no right to a hearing. 42 C.F.R. § 498.70(b). Petitioner has no right to a hearing concerning the April 1999 survey findings because they are not the basis for any remedy determination made by CMS. 42 C.F.R. §§ 498.3, 498.5.

As I discuss above at Part I of this decision, the New York State survey agency conducted several surveys of Petitioner in 1999 - including surveys that were conducted in April, May, and June of that year - and found Petitioner not to be complying with participation requirements at each of these surveys. Both CMS and Petitioner offered evidence and arguments concerning the deficiency findings that were made at the April, May, and June 1999 surveys. I received evidence which related to all of these surveys although I observed that I might find ultimately that evidence pertaining to the April 1999 survey was irrelevant to this case. Tr. at 4 - 8.

I now conclude that evidence relating to the April 1999 survey is irrelevant. Petitioner's compliance status as of the April 1999 survey is irrelevant to the question of whether CMS is authorized to impose the remedies that it determined to impose. It is irrelevant to the issue of whether CMS could impose the remedy of denial of payments for new Medicare admissions in May 1999 because CMS is justified in imposing that remedy based solely on the compliance findings that were made at the May 1999 survey. It is irrelevant to the issue of whether CMS could impose the remedy of termination of participation in Medicare in June 1999 because CMS is justified in imposing that remedy based solely on the compliance findings that were made at the June 1999 survey. Indeed, the compliance findings that were made at the May 1999 survey are also irrelevant to the issue of whether CMS had authority to terminate Petitioner's participation after the June 1999 survey.

As I explained to the parties during the hearing, CMS's authority to impose a remedy against a long term care facility - other than a civil money penalty - arises from that facility's compliance status as of the date that the remedy determination is made. Tr. at 4 - 8. If Petitioner was not complying with one or more participation requirements as of the June 1999 survey then CMS was authorized to terminate Petitioner's participation in Medicare irrespective of Petitioner's previous compliance status. See 42 C.F.R. § 488.456(b)(1). Conversely, if Petitioner was complying with all participation requirements as of the June 1999 survey then CMS would not be authorized to terminate Petitioner's participation in Medicare regardless of Petitioner's previous compliance status. The same analysis applies to deciding the question of CMS's authority to impose a denial of payments for new admissions against Petitioner after the May 1999 survey. Petitioner's compliance status prior to the May 1999 survey has no bearing on the question of CMS's authority to impose the remedy of denial of payment for new admissions as of the May 1999 survey.

Petitioner and CMS offered evidence and argument concerning Petitioner's compliance status as of the April 1999 survey because, according to them, it is relevant to establish Petitioner's past history of compliance with participation requirements or CMS's motivation for imposing remedies against Petitioner. But, neither Petitioner's compliance history, nor CMS's motivation for imposing remedies are at issue in this case. In this case, my authority is limited to hearing and deciding the question of whether a basis exists to impose remedies against Petitioner. 42 C.F.R. § 488.408(g). Whether such a basis exists depends on Petitioner's compliance status as of the dates when CMS determined to impose the two remedies that are at issue. It does not depend on Petitioner's compliance history. Nor does it depend on CMS's motivation for imposing remedies.

Throughout this case Petitioner has argued that the remedies that CMS determined to impose are the product of animus directed against it by the New York State survey agency and by CMS. Petitioner argues that events relating to the April 1999 survey evidence a pattern of animus against it. But, the presence or absence of possible animus is irrelevant to the issue of whether a basis exists to impose remedies. If evidence establishes that Petitioner was not complying with participation requirements as of the dates when remedies were imposed, then the motivation of the agency or agencies involved in imposing those remedies does not matter.

Petitioner argues that, in fact, remedies were imposed against it based on the findings of noncompliance that were made at the April 1999 survey. However, the two remedies that Petitioner identifies as being imposed as a consequence of the April 1999 survey - a State-directed plan of correction and State-imposed civil money penalties - are remedies that the New York State survey agency determined to impose and are not remedies that CMS determined to impose. CMS imposed no remedies against Petitioner based on the findings of noncompliance that were made at the April 1999 survey.

There is neither a basis in the Act or in regulations for me to provide Petitioner with a hearing so that it may challenge State-imposed remedies. The Act is the statutory source of authority for the Secretary of the Department of Health and Human Services (Secretary) to impose remedies against long term care facilities. The Act confers hearing rights on providers who challenge determinations made by the Secretary or CMS acting as the Secretary's delegate. Act, sections 1819(h), 1866(h)(2). The Act does not provide for hearings to challenge State survey agency determinations. Id.; Rulings at 2 - 3. The Secretary has implemented the Act with regulations at 42 C.F.R. Parts 483, 488 and 498. These regulations confer hearing rights on long term care facilities to challenge certain determinations that are made by CMS. 42 C.F.R. §§ 498.3, 498.5. They do not confer hearing rights to challenge determinations that have been made by State survey agencies.

3. CMS was authorized to terminate Petitioner's participation in Medicare effective June 17, 1999 because Petitioner failed to prove that it was complying substantially with all federal participation requirements as of the June 1999 survey.

I must decide whether or not Petitioner failed to comply substantially with any one of the 10 participation requirements that Petitioner is alleged not to have complied substantially with in the report of the June 1999 survey in order to decide whether CMS was authorized to terminate Petitioner's participation in Medicare. HCFA Ex. 9 at 1 - 9, 11 - 14. Failure by Petitioner to comply substantially with even one of those requirements provides CMS with authority to terminate Petitioner's participation. Act, section 1866(b)(2); 42 C.F.R. § 488.456(b)(1)(i); Beverly Health and Rehabilitation - Spring Hill, DAB No. 1696 (1999).

The evidence in this case establishes that, as of the June 1999 survey, Petitioner manifested failures to comply substantially with at least one participation requirement. Consequently, CMS was authorized to terminate Petitioner's participation in the Medicare program.

Below I analyze Petitioner's failure to comply substantially with three of the participation requirements for which Petitioner was cited at the June 1999 survey. I find that Petitioner failed to comply substantially with each of these requirements. It is unnecessary for me to analyze Petitioner's compliance with the other seven participation requirements that are cited in the report of the June 1999 survey inasmuch as a finding of even one failure by Petitioner to comply substantially with a participation requirement justifies imposition of the remedy of termination of participation. Therefore, I make no findings - either favorable to Petitioner or to CMS - concerning the other seven participation requirements.

a. Petitioner did not prove that it complied substantially with the requirements of 42 C.F.R. § 483.25.

At Tag 309 of the report of the June 1999 survey, the New York State survey agency surveyors alleged that Petitioner failed to comply substantially with the requirements of 42 C.F.R. § 483.25. HCFA Ex. 9 at 2 - 3. This regulation requires a facility to provide to each of its residents care and services that are necessary for that resident to attain or maintain the highest practicable level of physical, mental, and psychosocial well-being, in accordance with that resident's comprehensive assessment and plan of care. The surveyors alleged that Petitioner failed in two respects to comply with the requirements of the regulation. First, Petitioner is alleged to have failed to provide ongoing assessments of the pain being experienced by a resident who is identified in the survey report as Resident No. 3. Second, Petitioner is alleged to have breached aseptic technique in changing the dressing of a resident who is identified in the survey report as Resident No. 7.

CMS offered prima facie proof of Petitioner's failure to provide care to Residents Nos. 3 and 7 in accordance with the standards set forth in the regulation. Petitioner did not rebut this proof by a preponderance of the evidence. I conclude that Petitioner's failure to provide acceptable care to the two residents is sufficient evidence to support the broader conclusion that, as of the June 1999 survey, Petitioner was not complying substantially with the requirements of 42 C.F.R. § 483.25.

i. Resident No. 3

CMS offered evidence that Petitioner's staff failed to assess Resident No. 3's ongoing complaints of pain, to bring these complaints to the attention of the resident's physician, or to suggest treatment alternatives to the resident's physician that might have given the resident better relief than the care that had been prescribed for her. The resident had been experiencing chronic low back pain for which she was receiving medication and treatments with ice packs. HCFA Ex. 9 at 2. The resident continued to complain of severe pain and, on two occasions (including once, on June 10, 1999, when a surveyor observed the resident), the resident was observed to be writhing in pain. Id. Both of these episodes occurred in early June 1999. However, Petitioner's staff failed to make any reassessments of the resident's complaints of pain after April 30, 1999 and failed to suggest to the resident's physician any possible changes in the resident's treatment that might alleviate the resident's pain. Id.

The evidence which CMS offered of Petitioner's noncompliance in the care it provided to Resident No. 3 is prima facie proof that Petitioner failed to provide the resident with the care that was needed to attain the highest possible level of physical and mental functioning by the resident. More aggressive management by Petitioner's staff of the pain that Resident No. 3 experienced would not necessarily have given the resident greater relief from pain than the resident experienced. But, Petitioner was obligated to at least attempt to obtain the best possible pain management for the resident. The evidence offered by CMS suggests that Petitioner's staff merely followed the resident's physician's orders without assessing whether those orders provided effective care for the resident. The potential for harm to the resident is obvious. The resident might have experienced less pain had Petitioner's staff assessed the efficacy of the treatment ordered by the resident's physician and had it communicated its findings to the resident's physician.

Petitioner did not overcome this evidence of noncompliance. Petitioner argues, primarily, that it was following the orders given by Resident No. 3's treating physician and that it cannot be faulted for complying with those orders. But, the issue here is not whether Petitioner or its staff followed the physician's orders. What is at issue here is whether Petitioner assessed the efficacy of the medications and treatments that had been prescribed by the resident's physician and communicated its findings to the physician. The staff's professional obligations to the resident included performing ongoing assessments of the resident's complaints of pain and communicating its findings to the physician, along with suggestions for possible changes in the resident's treatment, in order to maximize the resident's pain relief. Petitioner did not prove that it did that.

Petitioner also argues that the resident's treatment record shows that its staff reacted promptly to the resident's complaints of pain and that the resident, in fact, obtained relief from the medication and ice packs that the staff administered to the resident. I do not question the diligence of Petitioner's staff in providing prescribed care to Resident No. 3. But, notwithstanding Petitioner's arguments, this resident's record shows that the resident continued to experience episodes of severe pain in early June 1999, some of which left her writhing in pain, more than a month after Petitioner's staff wrote a plan of care for the resident. The resident's pain was sufficiently severe that, at times, it interfered with her appetite or prevented her from participating in activities. HCFA Ex. 40 at 11 - 16. Yet, Petitioner's staff failed to consider the possibility that better or additional treatment might be provided to the resident.

Finally, Petitioner asserts that CMS seeks to impose on it a duty to second guess the care ordered by the resident's treating physician. It argues that, in Beverly Health & Rehabilitation - Spring Hill, DAB CR553 (1998), I found that a facility did not have the duty to second guess the diagnosis made by a resident's physician.

I disagree with this analysis. In Spring Hill, CMS (then HCFA) argued that a facility's staff should have found that a physician's diagnosis of a resident's medical condition was incorrect and should have challenged the care regime ordered by the physician. I found that the facility's non-physician staff did not have the duty to make its own diagnosis of the resident's illness in order to challenge the physician's subjective medical judgment. This situation is clearly distinguishable. CMS has not suggested in this case that Petitioner's staff should have challenged the physician's diagnosis of the resident's condition. All that Petitioner's staff was required to do here was to make observations and assessments of the resident's condition and communicate the findings to the physician. Serving as a physician's eyes and ears is an essential element of Petitioner's duty to its residents under 42 C.F.R. § 483.25.

ii. Resident No. 7

CMS offered evidence to show that Resident No. 7 was treated in a manner that contravened instructions given by the resident's treating physician. The resident suffered from multiple wounds and injuries to her lower extremities as a consequence of peripheral vascular disease and of surgery performed to treat the resident's condition. HCFA Ex. 9 at 2 - 3. The resident's treating physician prescribed that the resident's wounds be treated with daily changes of sterile dressings. Id. at 2. On June 10, 1999, a surveyor observed Petitioner's staff attempting to change the resident's dressings. The surveyor noted that the staff failed to position the resident properly in order to change the dressings. Id. The surveyor then observed that the staff allowed the resident's exposed foot to rest directly on the metal footrest of the resident's wheelchair. Id. When the surveyor questioned this alleged breach of aseptic technique, Petitioner's staff responded by placing the resident's foot on a pillow taken from the resident's bed, thereby allegedly placing the resident's foot in direct contact with the non-sterile pillow. Id. at 2 - 3.

The evidence that CMS offered concerning Resident No. 7 is prima facie proof of a failure by Petitioner to provide care that maximized the resident's physical well-being. The resident's physician instructed Petitioner's staff to provide care that minimized the risk that the resident's wounds might become infected. The evidence offered by CMS shows that the staff did not follow these instructions. The evidence shows a potential for more than minimal harm to the resident because the risk that the resident might suffer infection was heightened by the staff's failure to follow the physician's instructions.

Petitioner did not overcome this prima facie case of failure to comply substantially with a participation requirement. Petitioner argues, first, that its staff did not breach aseptic technique in changing the resident's dressings. It asserts that the evidence obtained by CMS shows only that the resident's heel came into contact with possibly septic surfaces when, in fact, the dressing changes were being made to the resident's toes. I do not find this argument to be persuasive. Petitioner offered evidence to prove that only the resident's heel came into contact with the nonsterile pillow. But, Petitioner did not rebut evidence that the resident's entire foot came into contact with the possibly septic surface of the metal footrest of the resident's wheelchair.

Petitioner relies on the testimony of Donna Richardson, its former Director of Nursing. Tr. at 191 - 192; 223 - 224. Ms. Richardson testified that it would not be a breach of sterile technique to rest the resident's heel on a pillow while changing a dressing on the resident's toes. Id. at 223 - 224.

However, Ms. Richardson was not present while the dressing was being changed and has no first hand knowledge of what happened. And, in fact, her testimony was predicated on only some of the surveyor's observations. As a consequence, it does not answer completely the observations and allegations that were made by the surveyor. The surveyor observed Petitioner's staff placing the resident's exposed foot - and not just the resident's heel - on the non-sterile metal surface of a wheelchair prior to changing the resident's dressing. HCFA Ex. 9 at 2. Thus, the surface of the resident's foot, which included areas that were wounded, was in contact with a potentially septic surface prior to the surveyor's intervention. It was only after the surveyor intervened that Petitioner's staff placed a pillow under the resident's heel. Id.

Second, Petitioner argues that CMS failed to establish even a prima facie case of a potential for more than minimal harm resulting to Resident No. 7 from Petitioner's use of non-sterile technique in treating the resident's wounds. It cites as authority my decision in Mediplex of Massachusetts, d/b/a Randolph's Crossings Nursing Center, DAB CR584 (1999), as support for its argument. It argues that in Mediplex I found that sterile technique was not necessary to treat a wound. I find the Mediplex decision to be distinguishable from this case. I based my decision in Mediplex on the unique facts of that case. Here, the facts differ and my conclusions about the potential for harm resulting from Petitioner's conduct are also different than my findings in Mediplex.

I did not find in Mediplex that all wounds may be treated in compliance with regulatory requirements by a facility's staff using non-sterile technique. In Mediplex, the resident's wound had been closed with sutures. The preponderance of the evidence in that case was that sterile technique was not required to clean the resident's closed wound. By contrast, in the present case the resident had an open and draining wound on her foot and the physician had prescribed sterile dressings. HCFA Ex. 9 at 2.

b. Petitioner did not prove that it complied substantially with the requirements of 42 C.F.R. § 483.25(c).

At Tag 314 of the report of the June 1999 survey, the New York State survey agency surveyors alleged that Petitioner did not comply substantially with the requirements of 42 C.F.R. § 483.25(c). This regulation requires, at 42 C.F.R. § 483.25(c)(2), that a facility provide necessary treatment and services to a resident who has pressure sores to promote healing, prevent infection, and prevent new pressure sores from developing. The surveyors alleged that Petitioner failed in three respects to provide care that satisfied the requirements of the regulation. As evidence, they cited Petitioner's treatment of residents identified as Resident No. 12, Resident No. 1, and Resident No. 3. I note, however, that while CMS made posthearing arguments concerning the care that Petitioner gave to Resident No. 12 and Resident No. 1, it did not argue that Petitioner's care of Resident No. 3 was deficient. See CMS's Post Hearing Brief at 51 - 54.

The evidence that CMS offered concerning the care that Petitioner gave to Resident No. 12 and to Resident No. 1 is prima facie proof that Petitioner was not providing care to these two residents in substantial compliance with the requirements of the regulation. I find that Petitioner failed to meet its burden of rebutting this prima facie proof. The failure by Petitioner to provide care to two of its residents that met regulatory requirements is sufficient for me to find an overall failure by Petitioner to comply with the requirements of 42 C.F.R. § 483.25(c).

i. Resident No. 12

CMS offered evidence to show that Petitioner's staff disregarded treatment directives that were intended to protect Resident No. 12 against the development of pressure sores. Additionally, it offered evidence to show that the staff was unaware that the resident had developed new pressure sores.

Resident No. 12 had developed pressure sores in the past while residing at Petitioner's facility. HCFA Ex. 9 at 3. Treatments were administered to the resident for his sores. These were discontinued on June 2, 1999 because the sores had healed. Id. However, the resident's treatment plan continued to call for the resident to wear lamb's wool booties while the resident was in bed in order to protect the resident's feet against the possible development of new sores. Id. On June 10, 1999 a surveyor observed the resident lying on his bed, continuously, for a two hour period while wearing shoes and socks. Id. The booties were on the resident's bed near the resident during this time period. The surveyor asked that the resident's shoes and socks be removed so that the resident's feet could be observed. Observation revealed reddened areas to both heels. Id. Later, on June 10, 1999, the surveyor observed that the resident had developed Stage II pressure sores on both of his buttocks. Id. On the following day, the surveyor observed the resident again being placed in bed on his back and buttocks for a period of about one hour. Id. Petitioner's staff again failed to place protective booties on the resident's feet. The facility's charge nurse indicated that she had been unaware that the resident had developed new pressure sores. Id.

The foregoing evidence establishes a prima facie case of Petitioner's failure to comply with 42 C.F.R. § 483.25(c)(2). It shows that Petitioner failed to carry out routine precautions to protect the resident's feet against the development of pressure sores. It shows also that Petitioner's staff was not attentive to the resident's condition and allowed him to remain in the same position for relatively lengthy periods of time. And, it shows that the staff was unaware that the resident had developed new sores. The potential for harm resulting from these failures to provide routine care is clear. Resident No. 12 was highly susceptible to developing pressure sores. Yet, the prima facie evidence offered by CMS shows that Petitioner's staff failed to provide care which was necessary to prevent new sores from developing.

Petitioner did not rebut this evidence. Petitioner discusses at considerable length all of the efforts that its staff engaged in to protect the resident against developing pressure sores. Petitioner's Post-Hearing Brief at 12 - 14. But, it fails to explain why, on the occasions observed by the surveyors, its staff had failed to implement some of these measures. Petitioner offers no explanation for the resident being allowed to lie in bed with his shoes on and without the protection of lamb's wool booties. Nor does Petitioner explain why the resident was allowed to lie or sit in one position for relatively lengthy periods of time.

Petitioner argues also that the resident's treating physician was satisfied with the level of care that was being provided to Resident No. 12. But, as satisfied as the physician may have been with the general level of care that Petitioner's staff gave to the resident, she did not rebut the specific allegations that, on June 10 and 11, 1999, staff was deficient in providing prescribed care to the resident.

Finally, Petitioner argues that any pressure sores that the resident developed were an unavoidable consequence of the resident's condition. However, CMS has not alleged that the resident developed avoidable pressure sores. See 42 C.F.R. § 483.25(c)(1). The allegations here are that Petitioner's staff failed to carry out prescribed preventive measures and thus failed to comply with the care requirements of 42 C.F.R. § 483.25(c)(2).

ii. Resident No. 1

The evidence offered by CMS is that Resident No. 1 had persistent pressure sores on the coccyx and the left foot. HCFA Ex. 9 at 3 - 4. The resident complained of discomfort resulting from the treatment that Petitioner's staff administered for the sore on the resident's coccyx. However, Petitioner's staff made no revisions to the resident's care plan to address the continuing pressure sore in the coccyx area and did not assess the resident's left foot to determine the efficacy of treatment. Id. at 4.

This evidence establishes a prima facie case that Petitioner did not provide necessary treatment and services for Resident No. 1's pressure sores. Given that the sores were not improving, Petitioner was under an obligation to explore treatment alternatives that might promote healing. The prima facie evidence is that Petitioner failed to do so, resulting in a potential for more than minimal harm to the resident.

Petitioner argues that Resident No. 1 was at high risk for developing pressure sores, thereby suggesting that any sores that the resident may have developed were unavoidable. However, as is true with Resident No. 12, CMS is not alleging that the resident developed avoidable sores. The allegation is that Petitioner did not do all that it should have done to manage the sores that the resident had developed.

Petitioner argues also that the resident's condition had not changed substantially, thereby suggesting that it was unnecessary for Petitioner's staff to consider new treatment approaches for dealing with the resident's pressure sores. Petitioner's Post-Hearing Brief at 14 - 15. The fact that the resident's condition may not have changed over time does not justify Petitioner's failure to consider modifications to the resident's care plan. A facility must do more than just maintain the status quo for a resident who suffers from pressure sores. A facility is obligated to promote healing.

What Petitioner does not address is the failure of Petitioner's staff to assess Resident No. 1's skin condition after May 18, 1999 in spite of lack of improvement in the resident's condition. However, this is the essence of CMS's allegation of noncompliance by Petitioner with the requirements of 42 C.F.R. § 483.25(c)(2) in providing care to the resident.

c. Petitioner did not prove that it complied substantially with the requirements of 42 C.F.R. § 483.25(h)(2).

At Tag 324 of the report of the June 1999 survey, the New York State survey agency surveyors allege that Petitioner failed to comply substantially with the requirements of 42 C.F.R. § 483.25(h)(2). This regulation requires that a facility ensure that each of its residents receives adequate supervision and assistance devices to prevent accidents. The surveyors alleged that Petitioner failed to comply with the requirements of the regulation in providing care to residents who are identified as Residents Nos. 8, 9,15, 16, and 17. HCFA Ex. 9 at 5 - 7.

As I discuss below, CMS established a prima facie case of substantial noncompliance by Petitioner with the regulation's requirements in the care that Petitioner gave to Residents Nos. 9, 15, 16, and 17. Petitioner did not establish by a preponderance of the evidence that CMS's allegations with respect to these four residents are incorrect. CMS did not establish a prima facie case of noncompliance with the regulation's requirements in the care that Petitioner gave to Resident No. 8. However, I conclude that the failure by Petitioner to provide adequate care to Residents Nos. 9, 15, 16, and 17 is sufficient to establish an overall failure by Petitioner to comply with the requirements of 42 C.F.R. § 483.25(h)(2).

The regulation does not impose a strict liability standard on a facility. Accidents happen at facilities despite the best and most prudent measures that may be taken to avoid them. The mere occurrence of an accident, therefore, is not necessarily a basis for finding a failure to comply with the requirements of 42 C.F.R. § 483.25(h)(2). However, the evidence in this case establishes that, for each of the residents that I discuss, Petitioner should have taken steps that were reasonably necessary to forestall the occurrence of forseeable accidents but failed to do so. I find it to be irrelevant that in most of these instances accidents did not occur. What matters here is the potential for harm. Petitioner's failure to take reasonable precautions to protect some of its residents placed them at risk of injury.

i. Resident No. 8

I do not find that CMS established a prima facie case that the care that Petitioner gave to Resident No. 8 did not comply substantially with the requirements of 42 C.F.R. § 483.25(h)(2). The regulation requires that a facility give its residents supervision and assistance devices that are sufficient to prevent accidents. But, the report of the June 1999 survey does not allege that Petitioner failed to provide such care for Resident No. 8. Rather, the report alleges that Petitioner failed adequately to document whatever care it provided to the resident. HCFA Ex. 9 at 6. Inadequacy of documentation of care - as opposed to inadequacy of care - is not necessarily a basis for a failure to comply with the requirements of 42 C.F.R. § 483.25(h)(2).

ii. Resident No. 9

The evidence offered by CMS is that Resident No. 9 was at a very high risk for choking and aspiration of food. HCFA Ex. 9 at 6 - 7. The resident suffered from dysphasia, but also was wearing a rigid cervical collar as a consequence of a suffering a cervical spine fracture. Id. The resident's physician ordered that the resident be fed on a one on one basis. Id. On June 10, 1999, a surveyor discovered the resident alone in her room while attempting to drink a cup of coffee. Id. at 7.

The foregoing evidence is prima facie proof of a failure by Petitioner to provide adequate supervision of Resident No. 9. Petitioner had a duty to supervise the resident while she attempted to eat and drink. Evidence introduced by CMS shows that, notwithstanding this duty, Petitioner left the resident unsupervised. The risk of harm to the resident is evident. The resident might choke if allowed to eat or drink unsupervised.

Petitioner asserts that Resident No. 9's eating and drinking was under the care of a speech pathologist. Petitioner argues that the speech pathologist concluded that the resident could consume thickened liquids without supervision and that the coffee that the resident was attempting to drink on June 10, 1999 was thickened. Therefore, according to Petitioner, it did not breach its duty to supervise Resident No. 9. Petitioner's Post-Hearing Brief at 23.

I do not find this argument to be persuasive. Petitioner has not denied that there was a physician's order that the resident be fed one on one. Petitioner has offered no evidence to show that the physician modified this order or that the physician deferred to a speech pathologist in determining how the resident was to be fed.

Moreover, the speech pathologist did not tell Petitioner's staff that it was permissible to allow the resident to consume thickened liquids without supervision. The speech pathologist said only that members of the resident's family might feed the resident with thickened liquids. But the speech pathologist never suggested that Petitioner's staff could absent themselves from the resident's presence while this occurred.

The speech pathologist's report was written to address a specific problem. M2087. Members of the resident's family were feeding the resident free-flowing liquids despite the fact that the resident's physician had ordered the resident to be fed with honey thickened liquids and also despite the fact that the family had been requested not to feed the resident. The pathologist concluded that it would be acceptable if the resident's son fed the resident honey thickened liquid but cautioned that only Petitioner's staff should feed the resident free-flowing liquids. Id.

Specifically, the speech pathologist says:

If . . . [Resident No. 9] remains on honey thickened liquid with no need for the modification, she will not be at risk. If she is changed back to free-flowing, it would only be safe if only staff provided the liquids and assisted her in the intake. Since family is reportedly unwilling to restrict their involvement, placing res. on free-flowing at this time would put her at ri[s]k.

M2087.

I read the speech pathologist's report as addressing only what family members might be allowed to do for the resident. The report neither states nor suggests that Petitioner's staff could absent itself from the room while a family member attempted to feed the resident. Indeed, the thrust of the report is to express concern that family members might inadvertently cause the resident to suffer harm if they attempted to feed her without supervision.

iii. Resident No. 15

The evidence offered by CMS shows that Resident No. 15 had difficulty walking secondary to severe cellulitis in her right leg. This put her at risk for falls. Petitioner's staff acknowledged the resident's gait problems and the attendant risk for falls. The resident's susceptibility for falling is recorded in the resident's care plan. HCFA Ex. 9 at 5. The resident's care plan stated that the resident should walk with assistance by one of Petitioner's staff while using a walker. Id.

During the May 1999 survey Resident No. 15 complained to a surveyor in the presence of a member of Petitioner's nursing staff that, during the previous night, she had almost killed herself while attempting to go to the bathroom by herself. HCFA Ex. 9 at 5. During that discussion the nurse observed that the resident should not attempt to ambulate on her own. However, on June 5, 1999 the resident sustained a fall while alone in her room at night.

The evidence presented by CMS concerning Resident No. 15 is prima facie proof that Petitioner did not provide the resident with adequate supervision or assistance devices to prevent the resident from sustaining falls. It shows that Petitioner's staff knew that the resident had severe gait problems and yet permitted the resident to ambulate unassisted at night. The evidence shows that the consequence of the staff's lax supervision of the resident was that the resident sustained a fall and was injured. HCFA Ex. 9 at 5.

Petitioner offers several arguments in response to this evidence. I find that they do not rebut the prima facie case of failure to comply with the requirements of 42 C.F.R. § 483.25(h)(2). First, Petitioner asserts that it properly investigated and reported the events related to the resident's June 5, 1999 fall. But these assertions do not address the question of Petitioner's failure to provide adequate supervision of or assistance devices to the resident.

Second, Petitioner asserts that the resident was, in fact, given supervision consistent with her care plan. I do not find this contention to be persuasive. The issue here is not whether Petitioner complied with the resident's care plan. The issue is whether Resident No. 15 was supervised adequately or provided with necessary assistance devices. The resident was vulnerable to falls when she attempted to ambulate without supervision. She should not have been permitted to ambulate alone at night regardless what her care plan said. I note, however, that the resident's care plan does not suggest that the resident should be allowed to ambulate while unsupervised.

Third, Petitioner argues that the resident in fact had acquired a relatively competent gait. It notes that, by June 5, 1999, the resident had progressed to the point where she could ambulate up to 80 feet with the aid of a walker while under supervision. Petitioner apparently suggests by this that the resident no longer needed close supervision as of June 5, 1999 and that the accident she sustained on that date was not forseeable. I am not persuaded by this argument. The fact is that even on June 5, 1999, the resident still was being provided supervision while she attempted to walk. There is nothing in the resident's record that Petitioner has pointed to which shows that the resident had progressed to the point where she could ambulate unsupervised. Indeed, the excerpt from the resident's record relied on by Petitioner proves the contrary to be true. M2080.

Finally, Petitioner argues that the resident wanted to be independent. Petitioner asserts that providing the resident with a bed alarm which would have alerted Petitioner's staff when the resident got out of bed at night or a bedside commode which would have minimized the resident's need to ambulate at night would not have been productive in light of the resident's desire. But, this argument is belied by the fact that, barely two weeks prior to sustaining her fall on June 5, 1999, the resident had complained that she was not getting assistance at night when she needed to use the bathroom. HCFA Ex. 5 at 9. Moreover, there is nothing in the resident's record to suggest that the resident had progressed to the point that she should attempt to ambulate without supervision and assistance. Indeed, on May 20, 1999 a member of Petitioner's staff commented that the resident should not attempt to ambulate alone. Id.

iv. Residents Nos. 16 and 17

CMS presented evidence to show that both Residents Nos. 16 and 17 were left alone by Petitioner's staff while they were being bathed in a device that is known as a Century tub. HCFA Ex. 9 at 5 - 6. A Century tub is a specialty tub that is designed to bathe disabled individuals. HCFA Ex. 12 at 1245 - 1246. It is approximately 2'7" deep, 28 inches wide, and 58 inches in length. Id. at 1246. Individuals who are bathed in the tub are put in a special seat and lifted hydraulically into the tub. Id. Individuals who are bathed in the tub wear a seat belt in order to reduce the dangers from sliding while in the tub. Id. at 1248. There is a risk of danger to individuals who are placed in a Century tub and left unsupervised. Id. Potential risks to unsupervised individuals include drowning. Id.

The evidence offered by CMS is prima facie proof that Petitioner failed to provide adequate supervision of Residents Nos. 16 and 17 to prevent these residents from sustaining accidents while they were in the Century tub. Both of these residents were frail, infirm individuals who were left alone by Petitioner's staff while partially submerged in the Century tub. From this evidence I infer that both of the residents were at risk for drowning while they were left in the tub unsupervised.

Petitioner offers several arguments in response to CMS's prima facie evidence. First, it argues that the design and standard use of a Century tub is such that it does not present any appreciable risk of accidents to individuals while they are in the tub. Petitioner's Post-Hearing Brief at 19. This argument is unsupported and is in fact belied by the manufacturer's manual for the Century tub which lists numerous risks to individuals while they are in the tub. M1921 at 1 - 14. Moreover, it is irrelevant. Leaving residents unsupervised while in the tub is not "standard use" of the tub.

Second, Petitioner asserts that the manufacturer's manual for the Century tub does not suggest that a hazard exists when a resident is left alone in the tub. Petitioner's Post-Hearing Brief at 19; see M1921 at 1 - 14. That may be true, but it also is irrelevant. A careful reading of the manufacturer's manual shows that it does not envision a circumstance where an individual would be left alone while in the tub. It is clear from the manual that the tub presents a host of risks to an unsupervised individual.

Third, Petitioner attacks the credibility of the surveyor who observed Resident No. 17 being left alone in the Century Tub. Petitioner's Post-Hearing Brief at 21. It points to a number of apparent discrepancies in that surveyor's accounts of what she observed as proof that the surveyor's overall testimony was not credible. However, Petitioner does not deny that Resident No. 17 was left alone for some period of time. Whether that was for five minutes as was attested to by the surveyor, or for some other amount of time, the fact is that Petitioner's staff left Resident No. 17, a 97 year old demented individual with impaired vision, alone in a tub that left him at least partially submerged. The risks resulting from that exposure are obvious and Petitioner has not shown how the actions of its staff did not consist of inadequate supervision of the resident.

Finally, Petitioner argues that there was no hazard in leaving Resident No. 16 alone in the Century tub because the resident was sufficiently capable that he could be left "safely alone" for a brief period. Petitioner's Post-Hearing Brief at 21 - 22. I do not find this argument to be persuasive. As I discuss above, the manufacturer's manual for the Century tub makes it plain that this is an extremely hazardous piece of equipment unless operated precisely according to the manufacturer's instructions. Leaving a resident alone for even a short period while partially submerged in water is not "safe".

4. CMS is authorized to impose against Petitioner the remedy of denial of payment for new Medicare admissions effective upon Petitioner's receipt of CMS's May 21, 1999 notice to Petitioner because Petitioner failed to prove that it was complying substantially with all federal participation requirements as of the May 1999 survey.

As I discuss above, at Finding 2, CMS may impose the remedy of denial of payment for new Medicare admissions against a long term care facility after a survey in which the facility is found not to be complying substantially with only one federal participation requirement. The report of the May 1999 survey cites Petitioner for not complying substantially with 10 separate participation requirements. HCFA Ex. 8. I conclude that Petitioner failed to comply substantially with requirements that are cited in the survey report.

Below I discuss Petitioner's failure to comply substantially with two of the requirements that are cited in the May 1999 survey report. I do not make findings that are either favorable or unfavorable to CMS or Petitioner concerning the remaining eight alleged deficiencies. I do not address Petitioner's compliance or noncompliance with the other eight requirements that are cited in the report because it is unnecessary that I do so.

a. Petitioner did not prove that it complied substantially with the requirements of 42 C.F.R. § 483.10(b)(11).

At Tag 157 of the report of the May 1999 survey, the New York State survey agency surveyors allege that Petitioner did not comply substantially with the requirements of 42 C.F.R. § 483.10(b)(11). This regulation requires that a long term care facility immediately inform a resident; consult with that resident's physician; and, if known, notify the resident's legal representative or an interested family member when there is:

(A) An accident involving the resident which results in injury and has the potential for requiring physician intervention; . . .

(D) A decision to transfer or discharge the resident as is specified in [42 C.F.R.] § 483.12(a).

A "transfer" of a resident is defined at 42 C.F.R. § 483.12(a)(1) to mean movement of a resident to a bed outside of a facility whether the bed is in the same physical plant or not.

CMS offered evidence to establish that a resident who is identified in the May 1999 survey report as Resident No. 3 sustained a fall on May 5, 1999 during which the resident hit her head. HCFA Ex. 8 at 2. A physician's assistant was notified of the event and the staff was directed to monitor her. At 3:00 a.m. on May 6, 1999, the resident was administered Tylenol in response to her complaint of a headache. Id. Later on the morning of May 6, 1999, the resident was sent to a hospital by the physician's assistant for evaluation of an elevated temperature and complaints of abdominal pain. Id. On May 8, 1999, a surveyor observed a family member arrive at Petitioner's facility to visit the resident. The family member was observed to verbalize that he was unaware of the resident's transfer to a hospital and to express concern at not being notified. The surveyors concluded that there was no evidence in the resident's record that the family member had been notified, either of the resident's fall, or of the change in the resident's condition which required that the resident be transferred to a hospital. Id.

The above-described evidence, if unrebutted, is prima facie evidence of a failure by Petitioner to comply with the requirements of 42 C.F.R. § 483.10(b)(11)(A) and (D). The regulation imposes a duty on a long-term care facility to notify a resident's family when there is an accident involving a resident that is sufficiently serious as potentially to require physician intervention or when the facility transfers the resident outside of its premises. Here, the prima facie evidence is that Resident No. 3 sustained an accident of sufficient severity so as to require family notification. The evidence also establishes that Petitioner, on its own volition, transferred the resident. In neither case did the resident's family receive the required notification.

Petitioner offers three arguments in response to this evidence. I do not find them to be persuasive.

First, Petitioner asserts that the individual who made the findings was not a certified surveyor. Therefore, according to Petitioner the allegations of noncompliance contained in the May 1999 survey report should be precluded from consideration. Petitioner's Post-Hearing Brief at 37. I do not find this argument to be persuasive because the issue is not whether the surveyor was qualified but the accuracy of the findings that are stated in the May 1999 survey report. If the findings in the report are accurate then they are prima facie evidence of noncompliance by Petitioner with participation requirements.

Second, Petitioner asserts that the regulation establishes a high threshold for required notification and that, therefore, the word "injury" in 42 C.F.R. § 483.10(b)(11)(A) should be interpreted narrowly. Petitioner asserts that Resident No. 3 was not, in fact, "injured" when she fell and hit her head. Therefore, according to Petitioner, it had no duty to inform the resident's family of the accident. Petitioner bases its argument as to how the word "injury" should be interpreted on the language contained in 42 C.F.R. § 483(10)(b)(11)(B). This subsection requires that notification be made where 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); . . . .

Petitioner reasons that an "injury" under subsection A must be as severe as a "significant change" in a resident's condition to warrant notification of the resident's family.

I disagree with this analysis. The two subsections were written to address different circumstances and were not intended to be read as requiring the same levels of harm to the resident as a threshold for notification. "Accidents" are events which may be due to negligence or misfeasance on the part of a facility. It is reasonable to require family notification of even a slight injury resulting from an accident because the facility should be apprised of any event where the facility may be at fault in causing potential harm. Thus, the regulation makes it plain that a resident sustains an injury that requires notification any time that the injury is sufficiently severe as potentially to require physician notification.

The standard for notification under 42 C.F.R. § 483.10(b)(11)(B) are more stringent than under 42 C.F.R. § 483.10(b)(11)(A) because subsection (B) addresses an entirely different circumstance than an accidental injury. It would be unreasonable to require a facility to notify a resident's family of minor changes in a resident's medical condition because that would impose an unduly onerous requirement on the facility. A resident's medical condition may be expected to fluctuate from day to day even where the facility is providing the best possible care to the resident.

The injury sustained by Resident No. 3 was sufficient injury to trigger the notification requirement. The undisputed evidence is that the resident struck her head during a fall and experienced at least some pain (a headache). As a consequence of that injury Petitioner's staff notified a physician's assistant.

Finally, Petitioner argues that the failure to notify the resident's family of the transfer of the resident was an isolated incident that did not rise to the level of a failure to comply substantially with participation requirements. I do not disagree with Petitioner that the evidence pertaining to Tag 157 shows an isolated failure by Petitioner to comply with participation requirements. But, the failure in this instance was not a simple error by Petitioner's staff that caused no potential for harm. The resident was absent from the facility for more than two days before a relative discovered the absence. It is reasonable to infer that the failure to notify would have continued had the family member not complained. It is also reasonable to infer that during this period the resident was in the hospital isolated from her family. There was a substantial potential for the resident to suffer emotional harm during the hospitalization.

b. Petitioner did not prove that it complied substantially with the requirements of 42 C.F.R. § 483.20(k)(3)(i).

At Tag 281 of the report of the May 1999 survey, the New York State survey agency surveyors allege that Petitioner failed to comply substantially with the requirements of 42 C.F.R. § 483.20(k)(3)(i). HCFA Ex. 8 at 2 - 10. This regulation requires that services provided or arranged by a long term care facility must meet professional standards of quality. The surveyors found that Petitioner failed to satisfy the requirements of the regulation in providing care to nine residents. These residents are identified in the survey report as Residents Nos. 5, 8, 9, 12, 16, 22, 23, 24, and 28. However, CMS offered evidence and argument as to only six of these residents. These are Residents Nos. 23, 5, 28, 9, 8, and 22. CMS's Post Hearing Brief at 26 - 34.

The survey report mis-cites the section of the regulation which is at issue as 42 C.F.R. § 483.20(d)(3)(i). Petitioner argues that the allegations of noncompliance are deficient on their face inasmuch as the specific fact allegations made at Tag 281 have nothing to do with that section of the regulation. It argues, furthermore, that to allow CMS to argue now that the surveyors and it meant to cite to 42 C.F.R. § 483.20(k)(3)(i) would be an amendment to the allegations of noncompliance that is prejudicial to Petitioner.

I have often ruled that CMS will not be permitted to change its allegations of noncompliance without giving a facility adequate notice of its intent to do so. Here, however, the notice that was given to Petitioner was certainly adequate to inform it that what is at issue under Tag 281 was Petitioner's compliance with the requirements of 42 C.F.R. § 483.20(k)(3)(i). Although the survey report cites to the wrong section of the regulation it quotes verbatim from 42 C.F.R. § 483.20(k)(3)(i) as the operative regulatory language that Petitioner allegedly contravened. HCFA Ex. 8 at 2 - 3. Petitioner would know explicitly what CMS was contending it failed to comply with by reading the text of the survey report. I note also that, in the codified regulation, there are no subparts to 42 C.F.R. § 483.20(d). Petitioner would have been disabused of any confusion about what was being alleged simply by reading the regulation as it was codified.

As I discuss below, CMS offered evidence sufficient to establish a prima facie case that Petitioner did not provide care which met professional standards of quality. Petitioner did not overcome by a preponderance of the evidence CMS's prima facie case of noncompliance with the requirements of 42 C.F.R. § 483.20(k)(3)(i). The evidence establishes that, in the cases of five of the six residents whose care is cited under Tag 281, Petitioner's staff did not provide care that met professional standards of quality. That is sufficient to establish a pattern of deficient care by Petitioner's staff and a potential for more than minimal harm to residents of Petitioner.

i. Resident No. 22

CMS offered evidence to show that Petitioner's staff failed to comply with the requirements of New York State law in documenting the disposition of a tablet of Darvocet N-100, a controlled substance. Resident No. 22 had a prescription for the administration of Darvocet N-100. HCFA Ex. 8 at 9. The evidence offered by CMS is that, on May 7, 1999, a nurse made a record that one tablet of the medication was "wasted." The evidence shows, however, that Petitioner's staff failed to provide a second signature on the record as is required by law. Id. CMS offered additional evidence to show that Petitioner's staff failed to document what happened to the wasted tablet of medication.

I am not persuaded that this evidence is prima facie evidence of a failure by Petitioner's staff to provide care that met professional standards of quality. CMS has not offered evidence addressing the seriousness, if any, of Petitioner's staff's alleged failure to comply with New York State law by not providing a second signature on the resident's mediation administration record. Nor has CMS provided any evidence to show that the resident actually needed the missing medication. The evidence shows that the medication was prescribed "p.r.n." (as needed). CMS did not offer evidence that the resident needed the dose of medication in question.

ii. Resident No. 23

The evidence offered by CMS concerning Resident No. 23 is that the resident was admitted to Petitioner's facility for restorative therapy suffering from a number of medical problems including a pelvic fracture, bilateral knee fractures, and dementia. HCFA Ex. 8 at 3. The resident came to the Petitioner's facility wearing an indwelling Foley catheter. Id. The physician's order for the resident's care, dated May 6, 1999, stated that the catheter may be removed after three to four days. However, the catheter remained in place as of May 12, 1999, six days after the resident entered Petitioner's facility. In an interview with a member of Petitioner's nursing staff on May 12, 1999, that employee stated that she had just become aware of the physician's order concerning the catheter.

The evidence offered by CMS establishes a prima facie case that Petitioner failed to provide care to Resident No. 23 that met professional standards of quality. On its face, this evidence shows that Petitioner was not attentive to a physician's orders concerning the removal of the resident's catheter. The evidence establishes also that at least the potential for harm existed in Petitioner's omission. Nursing notes on May 8, 1999 stated that Resident No. 23 was pulling at the catheter thereby suggesting that the catheter was causing the resident to experience discomfort. HCFA Ex. 8 at 3 - 4.

Petitioner asserts that the resident's physician did not order that the catheter be removed after three to four days. Petitioner's Post-Hearing Brief at 39 - 40. According to Petitioner, the physician only said that the catheter may be removed after three or four days and left it to Petitioner's staff's discretion to decide when to do so. Petitioner supports this assertion with the testimony of Michael Foster, M.D., who served as Petitioner's medical director. P. Ex. 3 at 2556 - 2560. Dr. Foster testified that the physician's order was written in a way that permitted the Foley catheter to be removed in three to four days, but which did not require that it be removed within three to four days. Id. at 2822. He testified that removal of the catheter by Petitioner's staff was not a decision that required his consultation.

I am not persuaded by this evidence. I do not question Dr. Foster's testimony that he gave Petitioner's staff discretion to decide on the precise timing for removal of the resident's Foley catheter. Nor do I find that removal of the catheter after the elapse of more than four days necessarily would have been inappropriate had the resident's condition warranted a delayed removal of the catheter. But, the evidence offered by CMS shows that the delayed removal of the resident's catheter was a consequence of an omission by Petitioner's staff to assess the resident's condition and to decide the most appropriate timing for removal. There was no exercise of judgment or discretion in this instance to delay removal of the catheter. Rather, the removal was delayed because the staff forgot to remove it. That is not care which meets professional standards of quality.

iii. Resident No. 5

CMS offered evidence that shows that Resident No. 5 suffered from both diabetes and an infection. HCFA Ex. 8 at 4 - 6. It asserted that there was a pattern of failures by Petitioner's staff to notify the resident's treating physician of potentially significant changes in the resident's medical condition.

The resident's medical record contained a directive requiring Petitioner's staff to notify the resident's treating physician whenever the resident's blood glucose levels exceeded 400. But, the resident's blood glucose levels equaled or exceeded 400 on several instances in April 1999 and the resident's physician was not called. Id. at 4. The resident's medical record also showed that on April 24, 1999 a physician's assistant had ordered a change in the amount of antibiotics to be given to the resident. However, there was a delay in receiving the antibiotic from the pharmacy resulting in a delay of about 31 hours in administering the antibiotic to the resident. The resident's physician was not notified of this delay. Id. at 5. Finally, the resident's medical record showed that, on May 1, 1999, the resident had experienced an elevated temperature. An unsuccessful attempt was made to notify the resident's physician. No follow up calls were made to the physician until the next day although the physician failed to respond to the initial notification that the resident had an elevated temperature. Id. at 5 - 6.

The evidence offered by CMS is prima facie evidence of a pattern of failures by Petitioner's staff to notify Resident No. 5's treating physician of potentially significant changes to the resident's medical condition. This evidence shows that there were several instances in which the resident manifested elevated blood glucose levels, but Petitioner's staff failed to follow a directive in the resident's records to notify the physician of that change. The evidence also shows that Petitioner failed to notify the resident's physician of a 31- hour delay in administering antibiotics to the resident and failed to act diligently to assure that the physician was aware of an episode in which the resident experienced an elevated temperature.

Petitioner did not rebut the prima facie case of noncompliance. First, Petitioner argues that there was no order signed by a physician that the resident's physician be notified of episodes in which Resident 5's blood glucose level exceeded a count of 400. Petitioner's Post-Hearing Brief at 40. But, whether or not this is true is irrelevant to deciding whether Petitioner's staff failed to comply with professional standards of quality of care in providing care to Resident No. 5. The resident's medical record contained a written directive that the physician be notified if the resident's blood glucose level exceeded 400. M0927. The reasonable inference that anyone on Petitioner's staff would have drawn from this instruction is that the physician wanted to be notified of elevated blood glucose levels. Given that, failure to abide by the directive constituted a dereliction of duty to the resident.

Second, Petitioner asserts that the delay in administering antibiotics to Resident No. 5 had a "negligible" effect on the resident. From this, Petitioner contends that there was no potential for more than minimal harm in failing to administer antibiotics timely to the resident. Petitioner relies on the testimony of its medical director, Dr. Michael Foster, as support for this contention. P. Ex. 3 at 2827 - 2828. This argument is not persuasive. The thrust of Dr. Foster's testimony is that a missed dose of antibiotics would not be significant in view of the fact that the course of antibiotics that was prescribed for Resident No. 5 was to be administered over a period of 14 days. Id. Arguably, that might be so for a short delay. However, he failed to explain how a delay of 31 hours in administering antibiotics to this resident would be insignificant. See Id. Moreover, CMS offered the testimony of its own expert physician, Dr. Melvin Oskvig, who presented a contrary view. HCFA Ex. 19 at 3338 - 3339. Dr. Foster's opinion does not overcome Dr. Oskvig's opinion by a preponderance of the evidence.

iv. Resident No. 28

The evidence offered by CMS which relates to Resident No. 28 establishes that this resident sustained an injury to her ankle as a consequence of a fall that occurred on May 2, 1999. HCFA Ex. 8 at 6. The resident's physician ordered that the resident's ankle be x-rayed, that ice be administered to the resident's ankle for a period of 24 hours, and that the resident not bear weight on the ankle for 24 hours. Id. An x-ray was taken which did not establish a fracture. On May 12, 1999, the resident was observed to be ambulating and complaining of pain. Id. at 7. The resident's records did not reveal that there had been a follow-up evaluation of the resident's injury, nor did they show that the resident's physician had been notified of the resident's continuing complaints of pain.

This evidence establishes a prima facie case of a failure by Petitioner's staff to provide care that met professional standards of quality. The resident had injured her ankle and was continuing to complain of pain 10 days later. Yet Petitioner's staff had not evaluated the resident's continuing complaints, nor had they discussed them with the resident's treating physician.

I do not find that Petitioner rebutted this prima facie evidence of noncompliance. Petitioner argues, essentially, that the resident's course of recuperation from her ankle injury was normal and expected for an injury of that type. Petitioner's Post-Hearing Brief at 43. It asserts that pain and swelling in the resident's ankle were not unexpected consequences of the injury. Consequently, according to Petitioner, it was not necessary or required that the resident be seen by her treating physician. Id.

However, this argument begs the question of what Petitioner's staff was obligated to do for the resident. The dereliction in duty to Resident No. 28 does not involve the care provided by the physician, but the care that was provided by Petitioner's staff. It may very well have been true that the resident's treating physician would have declined to modify or alter the resident's prescribed care had he been notified of the resident's continuing complaints of pain. But, the important point here is that, by failing to evaluate or assess the resident's complaints, Petitioner's staff deprived the physician of information that he should have received.

v. Resident No. 9

CMS offered evidence to establish that Petitioner's staff inserted a rectal tube into Resident No. 9 without a physician's order in an effort to relieve the resident's signs of abdominal distension and complaints of dyspepsia. HCFA Ex. 8 at 7 - 8. And, it offered evidence to show that inserting a rectal tube without a physician's order exceeds the permissible scope of nursing practice. HCFA Ex. 12 at 91; HCFA Ex. 13 at 341; HCFA Ex. 19 at 3413.

This evidence establishes a prima facie case of Petitioner's failure to provide care that met professional standards of quality. If not rebutted, the evidence offered by CMS establishes that Petitioner's staff contravened widely accepted standards of nursing practice when it inserted a rectal tube without a physician's order to do so.

Petitioner's attempted rebuttal is not persuasive. First, Petitioner argues that the rectal tube was a reasonable treatment for the resident's complaints and signs. Petitioner's Post-Hearing Brief at 44. However, whether or not a physician might ultimately have ordered the insertion of a rectal tube for Resident No. 9 is not being questioned here. The question is whether Petitioner's staff exceeded the bounds of that which nursing standards permitted it to do. That question is not answered by evidence showing that, in retrospect, what the staff did would have been authorized had a physician known about it.

Second, Petitioner contends that its staff had been advised by the New York State Department of Education that a physician's order for insertion of a rectal tube is not required if a facility has a policy allowing nurses to insert a rectal tube without a prior order by a physician. Petitioner's Post-Hearing Brief at 44; P. Ex. 2 at 2642 - 2643. I find this contention not to be persuasive. It rests entirely on the hearsay testimony of a member of Petitioner's staff. Petitioner offered no corroboration that the New York State Department of Education actually has a policy permitting nurses to insert rectal tubes without a physician's prior order, nor did Petitioner offer corroboration that such information actually was communicated to Petitioner's staff. Moreover, Dr. Milene A. Sower, Executive Secretary for the Board for Nursing and Respiratory Therapy, New York State Department of Education, testified that a "standing order" by a facility allowing its staff to insert a rectal tube without a prior physician's order is not permitted by New York State policy. HCFA Ex. 13 at 348.

vi. Resident No. 8

CMS offered evidence to establish that, on May 8, May 9, and May 10, 1999, Resident No. 8 was observed to be receiving oxygen. HCFA Ex. 8 at 8. It offered evidence to show that there was no statement in the resident's record which explained why the resident was receiving oxygen. Moreover, although Petitioner's policy required notification of a physician or a physician's assistant within 24 hours of administration of oxygen to a resident, there was no evidence in the resident's record that such notification had been provided. Id. CMS offered evidence to establish that no order was written by a physician's assistant directing that the resident receive oxygen until May 10, 1999. Id. CMS also offered evidence to show that professionally accepted standards of care permit a facility's staff to begin administering oxygen in an emergency without prior approval by a physician, but that the staff must then consult with a physician for further direction. HCFA Ex. 13 at 343 - 344. Petitioner's own internal policy is consistent with this standard of care. HCFA Ex. 8 at 8 - 9.

The aforesaid evidence, if unrebutted, establishes a prima facie case that Petitioner failed to provide care to Resident No. 8 that met professional standards of quality. The evidence shows that Petitioner's staff administered oxygen to Resident No. 8 for a period of three days without receiving prior authorization from a physician or physician's assistant and without notifying the physician or physician's assistant of the action. The prima facie evidence is that such action by Petitioner's staff contravenes professionally accepted standards of quality and Petitioner's own internal policies.

Petitioner's principal defense to these allegations is to argue that the resident had a medical condition which required administration of oxygen, that the resident had been administered oxygen previous to her admission to Petitioner's facility, while hospitalized, and that it was a "clerical oversight" that the hospital's records failed to contain an order for continued administration of oxygen to the resident. Petitioner's Post-Hearing Brief at 45. From this, Petitioner contends that administration of oxygen to Resident No. 8 was part of the normal therapy for the resident and that its staff committed no error in failing to receive authorization from a physician or physician's assistant before implementing oxygen therapy.

This argument does not address CMS's central contention concerning the care that Petitioner's staff gave to Resident No. 8. The issue here is not whether administration of oxygen to Resident No. 8 was appropriate, but whether Petitioner's staff failed to engage in requisite consultations with a physician or a physician's assistant after it began to administer oxygen. Petitioner failed to prove that it's staff was not required to engage in consultations. And, Petitioner did not prove that the mandatory consultations were made.

The fact that an order to administer oxygen might have been omitted from Resident No. 8's record of a prior hospitalization was not a license to Petitioner's staff to administer oxygen without consulting a physician. To the contrary, if staff was aware that the resident had been administered oxygen while in the hospital, but failed to receive an order to continue to administer oxygen, staff should have consulted with the resident's physician or a physician's assistant. But, staff did not do so.

The potential for harm in Petitioner's staff's failure to consult with a physician or a physician's assistant about the administration of oxygen to Resident No. 8 is evident, not only from Petitioner's failure to comply with the professionally accepted standards of quality for administration of oxygen, but by its failure to comply with its own internal policy. Good nursing practice required consultation after administration of oxygen and Petitioner's staff failed to consult.

Steven T. Kessel

Administrative Law Judge