CASE | DECISION | JUDGE | FOOTNOTES

Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Civil Remedies Division
IN THE CASE OF  


SUBJECT:

Beechwood Sanitarium,

Petitioner,

DATE: October 28, 2002
                                          
             - v -

 

Centers for Medicare & Medicaid Services

 

Docket No.C-02-455
Decision No. CR966
DECISION
...TO TOP

DECISION ON REMAND

I decided this case originally as Beechwood Sanitarium, DAB CR821 (2001). Subsequently, an appellate panel (panel) of the Departmental Appeals Board remanded the case to me in Beechwood Sanitarium, DAB No. 1824 (2002). I summarize my decision on remand as follows:

1. I decline to receive into evidence additional exhibits from Petitioner which it designated as F15111, F15112, F15113, F15114, F15115, F15116 and F15117 through F15164 because they are irrelevant. These exhibits are documents that the Centers for Medicare & Medicaid Services (CMS) produced in response to a subpoena that I issued to it on April 22, 2002. I decline to receive into evidence exhibits from Petitioner which it designated as M000011, M2485, and M2574 - 2575 because the exhibits relate to issues that were decided previously by me and affirmed on appeal and because Petitioner has not offered any reason why I should reopen these issues. I also decline to receive into evidence HCFA Ex. 48 and HCFA Ex. 49 (1) because they either address issues that are administratively final or are irrelevant.

2. Petitioner has not offered any evidence or arguments based on documents that were produced as a result of the subpoena I issued on remand that justify my reopening or reconsidering the findings of fact or conclusions of law (Findings) that I made in my first decision addressing the merits of this case.

3. I decline to make additional Findings or to respond to any argument that Petitioner made on appeal of my first decision except that I respond briefly to a concern raised by the panel at footnote 8 at page 20 of its decision.

4. I make Findings addressing deficiency findings and remedy determinations that were made based on the results of a Medicare compliance survey of Petitioner's facility completed on April 22, 1999 (April 1999 survey). The report of that survey alleged that Petitioner had not complied substantially with six Medicare participation requirements. HCFA Ex. 7. In this decision, I find that Petitioner failed to comply substantially with three of these requirements. Therefore, the New York State Department of Health, Division of Health Care Standards and Surveillance (New York State survey agency) was authorized to impose a directed plan of correction against Petitioner addressing these three deficiencies.

I. Background

This case involves imposition of remedies against Petitioner based on findings of noncompliance with Medicare participation requirements that were made at three compliance surveys conducted in 1999. These surveys, in addition to the April 1999 survey, included surveys that were completed on May 12, 1999 (May 1999 survey) and June 14 1999 (June 1999 survey). Based on the outcome of the April 1999 survey, the New York State survey agency determined to impose a directed plan of correction against Petitioner along with other remedies. After the May 1999 survey, CMS imposed the remedy of denial of payment for new Medicare admissions against Petitioner. After the June 1999 survey, CMS terminated Petitioner's participation in Medicare.

Petitioner filed a hearing request to challenge the survey findings and the imposition of remedies. I held an in-person hearing at which I received the testimony of several witnesses and documentary evidence from the parties. In my first decision, I found that Petitioner had no right to a hearing to challenge the remedy determinations that the New York State survey agency had made based on the April 1999 survey. I dismissed Petitioner's hearing request insofar as it pertained to that survey. I found that Petitioner was not complying substantially with Medicare conditions of participation as of both the May 1999 and June 1999 surveys. I sustained CMS's determination to impose the remedy of denial of payment for new Medicare admissions based on the findings of noncompliance that were made at the May 1999 survey. I sustained the remedy of termination of Petitioner's participation in Medicare based on the findings of noncompliance that were made at the June 1999 survey.

Petitioner appealed my decision. On appeal, the panel upheld my decision in some respects and reversed or remanded it in others. It held that Petitioner had a right to a hearing concerning the deficiency findings that were made at the April 1999 survey. In doing so, it acknowledged that CMS had not made a remedy determination based on the outcome of that survey, but it reasoned that CMS constructively had adopted the New York State survey agency's determination to impose a remedy because it did not reject that determination. Consequently, it directed me to issue a decision in which I addressed the deficiency findings that the New York State survey agency made at the April 1999 survey. It held that I erred in not issuing a subpoena sought by Petitioner for certain documents that were allegedly generated by "federal surveyors." It directed me to issue a subpoena to CMS for the production of these documents. It directed me to receive evidence consisting of or relating to the subpoenaed documents that bore on the merits of the case and to modify or make new Findings to the extent that this evidence had an impact on my original Findings. Finally, it invited me to address arguments that Petitioner made in its appeal concerning the Findings that I made in my decision about the May 1999 and June 1999 surveys.

I conducted additional proceedings to comply with the panel's remand order. I issued a subpoena to CMS. I allowed both parties to offer additional evidence and to provide me with briefs addressing the issues that had been remanded to me.

II. Issues on remand and Findings

A. Issues on remand

In this decision on remand, I address the following issues:

1. Should I receive into evidence additional exhibits offered by Petitioner and CMS on remand?

2. Has Petitioner offered any basis to justify my reconsidering the Findings that I made in my first decision concerning the May 1999 and June 1999 surveys?

3. Should I address on remand issues that the parties raised on appeal of my first decision?

4. Did Petitioner fail to comply substantially with one or more Medicare participation requirements as of the April 1999 survey?

5. Was the New York State survey agency authorized to impose a directed plan of correction against Petitioner to address Petitioner's noncompliance with participation requirements as of the April 1999 survey?

B. Findings

I make Findings to support my decision on remand. I set forth each Finding below as a separately numbered heading and I discuss each Finding in detail. My first decision in this case had four numbered Findings. In order to avoid confusion I am numbering my Findings in this decision on remand beginning with Finding 5.

5. I decline to receive into evidence Petitioner's exhibits F15111, F15112, F15113, F15114, F15115, F15116, and F15117 through F15164. I also decline to receive into evidence Petitioner's exhibits M00011, M2485, and M2574 - 2575. Additionally, I decline to receive into evidence HCFA Ex. 48 and HCFA Ex. 49.

I decline to receive into evidence Petitioner's exhibits F15111 - F15116 and F15117 -F15164. These exhibits consist of documents that the panel ordered that I subpoena from CMS. They contain no relevant evidence.

I note that Petitioner offered into evidence all of the exhibits that it obtained as a consequence of the subpoena that I issued except for F15114. Petitioner's brief on remand at 2. It is unclear why Petitioner omitted to offer this exhibit and it may be that it failed to do so inadvertently. In any event, my ruling as to admissibility of the subpoenaed documents applies to F15114 along with the other subpoenaed documents.

Petitioner sought a subpoena because it averred that CMS had in its possession notes from "federal surveyors" that bear on the findings of noncompliance made at the three surveys that are at issue in this case. The documents that Petitioner sought to subpoena, and which the panel ordered that I subpoena, are distinguishable from other documents that I ordered CMS to turn over to Petitioner and which CMS produced prior to the hearing that I held in this case. Those other documents are notes and reports generated by the New York State survey agency surveyors who participated in the three surveys of Petitioner. In fact, and as is made clear by the declaration of Sue Kelly, CMS's Associate Regional Commissioner, there were no "federal surveyors" participating in any of the surveys. F15111 - F15112. The notes that CMS turned over in response to the panel-directed subpoena were those of people employed by CMS's Regional Office at the time of the surveys. They did not participate in the surveys. Their role was limited to reviewing the survey findings that were made by New York State survey agency surveyors. Id; see F15113 - F15116; F15117 - F15164. Specifically, F15113 - F15116 consist of notes that the CMS employees made concerning their review of the findings of noncompliance that surveyors made at the April 1999 survey and F15117 through F15164 is a copy of the April 1999 survey report with some marginal notes allegedly made by CMS employees. (The April 1999 survey report without the marginal notes is already in evidence as HCFA Ex. 7.)

The notes by the CMS employees are irrelevant to the issues that I am hearing and deciding in this case because they contain no direct evidence of Petitioner's compliance or noncompliance with participation requirements. This case does not comprise a review of the acumen and judgment of CMS's Regional Office employees. These employees' impressions of the evidence collected by or the quality of the work of other persons has nothing to do with the merits. This case is a de novo hearing addressing the question of whether Petitioner was complying with Medicare participation requirements as of the dates of the surveys. What is relevant to this case is the objective evidence that relates to Petitioner's actual compliance or noncompliance as of the survey dates. The notes that the CMS Regional Office employees generated are as irrelevant to the merits of this case as are my own notes or those written by the panel members in the course of their evaluation of the appeal of this case.

Petitioner devotes considerable argument in its brief on remand to an alleged lack of confidence by CMS employees in the surveyors' findings made at the April 1999 survey. Petitioner's brief on remand at 10 - 16. I am not persuaded from Petitioner's analysis or from my review of the proffered exhibits that there actually existed a significant difference of opinion between the surveyors and CMS's employees as to what was found or not found at the April 1999 survey. But, even had that been the case, such a difference of opinion is irrelevant. That is because the issue before me is not whether CMS's employees agreed with the surveyors, but what the objective first-hand evidence shows about the conditions prevailing at Petitioner's facility at the time of the April 1999 survey.

I decline to receive into evidence M000011, M2485, and M2574 - 2575. These exhibits are documents that Petitioner had in its possession as of the in-person hearing of this case, but which Petitioner did not move into evidence at that time. I decline to admit them now for three reasons. First, Petitioner made no showing that it failed to offer them previously because it did not have access to the subpoenaed documents. In fact, the issues to which these exhibits relate have nothing to do with the merits of this case or with the subpoenaed documents. Second, I have already decided the issues to which the exhibits relate and my decision as to these issues was sustained by the panel on appeal. Those issues are administratively final. Third, Petitioner has not made any credible showing as to why I should reconsider my previous decision.

M00011 is a copy of a notice placed in a newspaper on May 15, 1999. Petitioner appears to be offering it to support its contention that CMS's remedy determinations are not valid because CMS improperly published notice of its determinations. I decided that issue in my first decision in this case and the panel affirmed my decision at pages 15 - 16 of its decision. M2485 and M2574 - 2575 are excerpts from a State administrative law judge decision which affirmed the imposition of a State financial penalty against Petitioner. Petitioner is offering these exhibits in order to challenge the State administrative law judge's decision as to remedy. I decided in my first decision that I had no authority to hear and decide that issue and the panel affirmed that conclusion at pages 9 - 10 of its decision.

Finally, I decline to receive into evidence HCFA Ex. 48 and HCFA Ex. 49. HCFA Ex. 48 was offered by CMS to clarify an issue that has already been decided by me and by the panel. I see no need to reopen the record to receive "clarifying" evidence as to that issue. HCFA Ex. 49 is a duplicate of Petitioner's exhibit F15114. CMS offered this exhibit so as to complete the record in light of Petitioner's failure to offer it. I am not receiving this exhibit because it is irrelevant and also because I have declined to receive the other documents that CMS produced in response to the subpoena that I issued.

6. Petitioner offered no basis to justify my reconsidering the Findings that I made in my first decision concerning the May 1999 and June 1999 surveys.

Petitioner has offered no arguments based on the contents of the subpoenaed documents that raise any legitimate reason for me to revisit the Findings that I made concerning the May 1999 or June 1999 surveys. Nor has Petitioner pointed to any evidence that might reasonably be related to or emanate from the subpoenaed documents that would justify my revisiting those Findings. As I discuss above, at Finding 5, the documents that CMS produced in response to the subpoena that I issued are irrelevant to the issues in this case because they contain no objective evidence of Petitioner's compliance with participation requirements. Furthermore, they relate only to CMS employees' impressions of the findings that surveyors made at the April 1999 survey. Nothing in these documents bears on the findings that were made at the May 1999 or June 1999 surveys.

In my original decision in this case, I addressed only some of the deficiency findings that were made at the May 1999 and June 1999 surveys of Petitioner. I held that the presence of even one failure by Petitioner to comply substantially with a participation requirement at a survey justified CMS's determination to impose remedies against Petitioner including denial of payments for new admissions and termination of participation. On appeal the panel sustained this analysis. Petitioner now argues that I should expand my review of the May 1999 and June 1999 surveys to address all of the deficiencies that were identified at these surveys. Petitioner's brief on remand at 6 - 7. According to Petitioner, I should do so because CMS's documents do not "document any basis for application of the remedies imposed based on the allegations in the May and June . . . [survey reports]." Id. at 7 - 8.

It is not entirely clear what Petitioner means by this assertion, but it appears to be arguing that I should greatly expand the scope of my review of the findings made at the May 1999 and June 1999 surveys because CMS's internal documents allegedly do not show how CMS came to the conclusion that the remedies it determined to impose were justified. I find this argument - if that is what Petitioner is contending - to be unpersuasive. As I discuss above, this case is not a review of CMS's regional staff's acumen in determining to impose remedies. Rather, it is a de novo inquiry into the conditions that arguably are the basis for remedies. If alleged noncompliance with participation requirements is justified by objective evidence relating to the care that Petitioner gave or failed to give to its residents then remedies are justified regardless whether CMS's internal documents show CMS's employees to have been indecisive or conflicted about imposing remedies.

7. I decline to address arguments that the parties made on appeal concerning the Findings I made about the May 1999 and June 1999 surveys.

The panel suggested that I might want to consider on remand the arguments that the parties raised in their appellate briefs. I decline to do so with the exception of a brief discussion that addresses one of Petitioner's arguments on appeal which the panel highlighted in footnote 8 to its decision.

At footnote 8, the panel noted that:

[Petitioner] contended that the . . . [administrative law judge] committed an error of law with respect to his findings on Residents No. 3, No. 12, and No. 1 in the June survey and Residents No. 23 and No. 28 in the May survey by downgrading the deficiencies alleged concerning these residents to a severity level of potential for harm as opposed to the actual harm level alleged by CMS.

Panel decision at 20, n.8.

In my first decision, I found that instances of noncompliance by Petitioner with Medicare participation requirements were "substantial" within the meaning of governing regulations because the actions or inactions of Petitioner posed the potential for causing more than minimal harm to a resident or residents of Petitioner's facility. I made these findings because a "potential for causing more than minimal harm" is the regulatory test for deciding whether a failure to comply with the letter of a regulation is substantial and not minimal. 42 C.F.R. § 488.301.

In doing so, I made no findings about the actual scope and severity of the deficiencies at issue. I neither sustained nor "downgraded" CMS's scope and severity findings. I did not address the issue of scope and severity for two reasons. First, the deficiencies' scope and severity is irrelevant to the issue of whether CMS is authorized to impose remedies once the deficiencies are shown to pose a potential for causing more than minimal harm. A deficiency is "substantial" and CMS may impose remedies to address that deficiency if it meets the regulatory test that I have cited above regardless whether the scope and severity that CMS or a State survey agency assigned to the deficiency is greater than a potential for causing more than minimal harm.

Second, a facility may not challenge the scope and severity of a deficiency, except in very limited circumstances that are not involved in this case, and I generally have no authority to consider a facility's challenge to a deficiency's scope and severity. See 42 C.F.R. § 488.408(g)(2). A facility may challenge CMS's authority to impose a remedy by asserting that any deficiencies it manifests are not substantial. But, it may not challenge CMS's choice of remedy by asserting that CMS's scope and severity determination is wrong. Id. That is because "scope and severity" of a deficiency is a factor that relates only to CMS's choice of remedy and not to CMS's authority to impose a remedy.

8. Petitioner failed to comply substantially with Medicare participation requirements as of the April 1999 survey.

The report of the April 1999 survey identifies six alleged failures by Petitioner to comply substantially with Medicare participation requirements. These alleged failures are identified at Tags 224 (HCFA Ex. 7, at 1 - 14), 314 (HCFA Ex. 7, at 14 - 17), 324 (HCFA Ex. 7, at 17 - 22), 490 (HCFA Ex. 7, at 22 - 23), 493 (HCFA Ex. 7, at 23 - 24), and 514 (HCFA Ex. 7, at 24 - 32). Based on these findings, the New York State survey agency issued a directed plan of correction to Petitioner which prescribed remedial steps that Petitioner was to take to rectify each of the identified deficiencies.

In this decision on remand, I evaluate each of the alleged deficiencies in the report of the April survey based on the evidence that I received at the hearing. I sustain the New York State survey agency's findings at Tags 224, 324, and 490. I do not sustain that agency's findings at Tags 314, 493, and 514.

In my original decision, I held that it was unnecessary for me to consider all of the deficiency findings that were made at the May 1999 and June 1999 surveys in order to decide whether CMS is authorized to impose remedies against Petitioner consisting of denial of payments for new admissions based on the May 1999 survey findings or termination of participation in Medicare based on the June 1999 survey findings. That is because under both the Social Security Act (Act) and implementing regulations, it is only necessary that there be a single failure by a facility to comply substantially with a Medicare participation requirement in order for CMS to have authority to impose remedies including denial of payment for new admissions or termination of participation in Medicare. The panel sustained this holding. In its analysis, the panel observed that:

Obviously, our analysis of whether the . . . [administrative law judge] could properly limit his findings to the minimum deficiencies needed to provide a basis for a remedy is equally applicable to his review of the April survey upon remand.

Panel decision at 17, n.6.

In fact, and with all due respect to the panel, its analysis is not "equally applicable" to an appeal of a directed plan of correction. The panel's remand to me of Petitioner's challenge of the deficiency findings that were made at the April 1999 survey leaves me with no choice but to analyze every deficiency finding made at the April 1999 survey in order to decide whether the directed plan of correction that was imposed to remedy those findings is authorized. I do so at parts a. through f. of this Finding.

The directed plan of correction that the New York State survey agency imposed in this case after the April 1999 survey was directed at all of the deficiencies that were identified in the report of that survey. HCFA Ex. 2; HCFA Ex. 7. For that reason, it is not enough for me to find a single deficiency and conclude that it provides a basis for the New York State survey agency to impose a directed plan of correction. The presence of a particular deficiency only authorizes an agency to impose a directed plan of correction for that deficiency. The finding of a single deficiency does nothing to resolve the issue of the agency's authority to impose other elements of the directed plan of correction that address other alleged deficiencies. In order to decide whether those other elements are authorized, I must decide whether the other alleged deficiencies that are the basis for those elements are substantiated. (2)

a. Petitioner did not prove that it complied substantially with the requirements of 42 C.F.R. § 483.13(c).

At Tag 224 of the report of the April 1999 survey, the New York State survey agency surveyors alleged that Petitioner failed to comply substantially with the requirements of 42 C.F.R. § 483.13(c). This regulation requires a facility to develop and implement written policies and procedures that prohibit mistreatment, neglect, and abuse of residents and misappropriation of resident property. I note that the survey report also cited subpart (c)(1)(i) of the regulation. However, the allegations of noncompliance in the report only address the language that I have cited.

CMS alleges that Petitioner's staff failed to implement procedures designed to assure that residents were not neglected. Specifically, it asserts that, with respect to five residents who are identified in the survey report as Resident Nos. 1, 2, 3, 4, and 6, Petitioner failed to implement policies that assured that the residents' physicians were notified of significant changes in the residents' medical conditions. It alleges that Petitioner's staff instituted treatments for several of these residents without first obtaining required physicians' orders. And, it asserts that there were several specific instances in which Petitioner's staff failed to attend to the residents' immediate needs.

I have analyzed CMS's allegations as they pertain to each of the residents whose care is at issue. At subparts i- v of this Finding, I conclude that CMS established prima facie cases of instances of neglect of residents' needs consisting of: failures by Petitioner's staff to notify physicians of significant changes in residents' conditions; and/or, administration of unauthorized treatments to residents by Petitioner's staff. Petitioner did not rebut this prima facie evidence of neglect by the preponderance of the evidence.

Viewed individually, these episodes of neglect do not depict necessarily a failure by Petitioner to implement policies and procedures that were designed to prevent neglect of its residents. An isolated instance of neglect is not per se proof of a failure by a facility to implement a broad policy against neglect. But, when these episodes are viewed as a group, they establish a pattern of neglect. This pattern is sufficient, in my judgment, to establish an overall failure by Petitioner to implement policies and procedures designed to prevent neglect. It is manifest that a potential for more than minimal harm to residents existed in Petitioner's failure to implement anti-neglect procedures. Failures by Petitioner's staff to notify physicians of potentially life-threatening changes in residents' conditions clearly posed a threat of more than minimal harm to residents. So, also, did failures by Petitioner's staff to obtain a physician's order before instituting certain medical treatments like administration of oxygen or insertion of a rectal tube.

i. Resident No. 1

Resident No. 1 lived in Petitioner's facility beginning in September 1998. His condition deteriorated during his stay and, on more than one occasion, the resident was sent to a hospital for evaluation and treatment. He was sent to hospital briefly for evaluation on February 9, 1999. He returned to the facility later that day. The resident was hospitalized again on February 16, 1999 and expired on that day.

CMS alleges that, between February 9 and 16, 1999, Resident No. 1 was not seen by a physician and Petitioner's nursing staff failed to notify the resident's physician of changes in the resident's condition that indicated serious deterioration. Prima facie evidence offered by CMS shows that, during this period of time, the resident manifested a fever, blue lips, blue nails, possible fecal contamination of his urine, vomiting, liquid diarrhea, bowel distention, and breathing difficulties. HCFA Ex. 7, at 4 - 7; HCFA Ex. 12, at Tr. 39 - 40. There is no evidence that the resident's physician was notified of these changes during the period when they occurred. The failures to notify the resident's physician of significant changes in the resident's condition, were, in the opinion of the nurses who surveyed Petitioner, a serious deviation from accepted standards of care governing nursing. HCFA Ex. 12, at Tr. 43 - 44; HCFA Ex. 19, at Tr. 3411 - 3414.

CMS also offered prima facie evidence to show that Resident No. 1 received medical treatments that should not have been provided to the resident without a physician's order first having been obtained. These unauthorized treatments included the administration of oxygen to the resident and insertion of a rectal tube. HCFA Ex. 12, at Tr. 39 - 41, Tr. 43 - 44. The prima facie evidence is that insertion of a rectal tube without a physician's order contravened applicable standards governing nursing care. HCFA Ex. 13, at Tr. 341 - 342; HCFA Ex. 19, at Tr. 3413. A nurse should not begin to administer oxygen to a resident without first obtaining a physician's order except in an emergency. HCFA Ex. 12, at Tr. 343 - 344. Even in an emergency situation, however, the nurse should immediately notify the physician of his or her action and obtain approval. Id.

Although Petitioner makes several arguments in response to CMS's evidence, it does not persuasively refute either the allegations that its staff failed to notify Resident No. 1's physician between February 9 and 16, 1999 of significant changes in the resident's condition or that the staff gave treatments to the resident that were not specifically authorized by a physician.

Petitioner argues, first, that it had developed a "very lengthy and detailed care plan" which addressed Resident No. 1's medical challenges. Petitioner's post-hearing brief at 78. It goes on to discuss the medical problems encountered in caring for Resident No. 1, especially the resident's severe decubitus ulcer. Id. All of these assertions may be true, but they beg the question of whether Petitioner neglected the needs of Resident No. 1 between February 9 and 16, 1999.

Second, Petitioner asserts that there was ongoing communication between the resident's physician and Petitioner's staff during the period between February 9 and 16, 1999. Petitioner's post-hearing brief at 78; 80. According to Petitioner, "[t]hese ongoing conversations were not and need not be documented, since no change in . . . [Resident No. 1's] care resulted from them." Id. This obviously is a self-serving argument and I find it not to be credible. The undisputed evidence is that Resident No. 1 was deteriorating rapidly during the period from February 9 - February 16, 1999. It defies logic that Petitioner's staff would have communicated to the resident's physician the changes in condition that marked the resident's deterioration and eventual death, but failed to record these communications because the physician did not order treatment changes. How would the staff have known that the physician would not order such changes until after it had made the communications? I find that the better explanation for absence of documentation of communications in the resident's record is that the communications did not occur.

Third, Petitioner asserts that the resident's physician had "preauthorized" the nursing staff at Petitioner's facility to use oxygen whenever needed and that he did not expect to write an order prior to the administration of oxygen by the staff. Petitioner's post-hearing brief at 80. Petitioner also asserts that insertion of a rectal tube was an "appropriate intervention" in order to assist the resident. I do not find this evidence to be persuasive evidence that Petitioner did not neglect the resident's needs. I am persuaded by the credible evidence presented by CMS that applicable standards of nursing care require a nurse to get a physician's order prior to administering oxygen. HCFA Ex. 12, at Tr. 343 - 344. I do not agree with Petitioner that "preauthorizing" such care is an acceptable substitute for obtaining a physician's order. Moreover, I find that it is not acceptable nursing care for a nurse to insert a rectal tube without a physician's order regardless whether, in retrospect, the care turns out to be appropriate. I discussed my analysis of this issue in detail in my original decision in this case at pages 28 - 29.

ii. Resident No. 2

Resident No. 2 was an elderly individual. She sustained a fractured hip on March 24, 1999 and she died on April 4, 1999. CMS offered evidence to show that, in the days and hours before the resident's death, Petitioner's staff neglected the resident's needs in the following respects:

• Petitioner's staff administered Tylenol with codeine to the resident on March 24, 1999. There was a written physician's order for the administration of the medication. HCFA Ex. 14, at Tr. 408 - 409. However, no physician's signature was obtained by Petitioner's staff. Id. at Tr. 409. Failure to obtain the physician's signature violated New York State law and applicable standards of care governing nursing practice. HCFA Ex. 13, at Tr. 342, 345 - 346; CMS's post-hearing brief at 19.

• Petitioner's staff administered a glycerine suppository to Resident No. 2 on April 4, 1999. The resident's treatment records show that a telephone order was received from the resident's physician for administration of the suppository. In fact, the physician was not contacted prior to administration of the suppository and did not authorize its administration in advance of it being given to the resident. HCFA Ex. 14, at Tr. 372 - 373; 374. A written order for the administration of the suppository was present in the resident's record at the time of the survey but was not signed by the resident's physician. Id.; HCFA Ex. 14, at Tr. 408.

• On April 4, 1999, Petitioner's staff attempted to contact Resident No. 2's physician. However, the physician did not return the call and contact was not achieved.

I do not find that CMS's allegation concerning Petitioner's attempt to notify Resident No. 2's physician on April 4, 1999 is supported by prima facie evidence of neglect. The evidence fails to show that, in calling the physician on that date, Petitioner's staff was inattentive to the resident's needs.

However, the evidence pertaining to administration of Tylenol with codeine on March 24, 1999 and administration of a glycerine suppository on April 4, 1999 is prima facie evidence of neglect. The prima facie evidence is that prior physician approval was a necessary prerequisite to administration of these drugs. Petitioner's staff did not obtain the required prior approval.

Petitioner did not overcome the prima facie evidence of neglect introduced by CMS. Petitioner argues that it provided high quality and intensive care to the resident over a period of years. Petitioner's post-hearing brief at 82. It asserts that it monitored adequately the resident's condition after the resident sustained a fractured hip. Id. It asserts that the resident did not have problems with her bowels prior to April 4, 1999. Id. at 82 - 83. I am willing to accept as true all of these assertions, but they do not address the allegations of neglect made by CMS. The history of care that Petitioner gave to Resident No. 2 does not refute the evidence showing that Petitioner's staff failed to obtain physician approval for the administration of medication when that approval was required.

As to the issue of approval, Petitioner cites to the testimony of the resident's treating physician that the resident had a standing order for the administration of a glycerine suppository. Petitioner's post-hearing brief at 83. I find this evidence not to be persuasive. Generalized standing orders that are not individualized to deal with the specific needs of each resident are not an acceptable substitute for the requirement that a physician approve the administration of specific types of medication and care, including suppositories, oxygen, pain killers containing controlled substances, or the insertion of a rectal tube. HCFA Ex. 13, at Tr. 345 - 347; HCFA Ex. 19, at Tr. 3414 - 3415.

iii. Resident No. 3

Resident No. 3 was an elderly individual. On March 30, 1999, the resident vomited a large quantity of liquid and developed a fever of 103.4 degrees Fahrenheit. Subsequently, the resident had several episodes of fever. The resident was assessed by his treating physician on April 2, 1999, and on that date treatment was begun for aspiration pneumonia. The resident expired on April 4, 1999.

CMS offered prima facie evidence that Petitioner's staff neglected Resident No. 3's care because it did not notify the resident's treating physician of the resident's deteriorating condition until April 2, 1999. The staff failed to notify the physician of the resident's 103.4 degree Fahrenheit fever on March 30, 1999 or of the associated signs of illness including vomiting. HCFA Ex. 7, at 9 - 10; HCFA Ex. 14, at Tr. 377. CMS offered evidence that shows that the failure to notify the resident's physician of the fever on March 30, 1999 was especially egregious in light of the resident's age and overall condition as of that date. HCFA Ex. 14, at Tr. 377, 449, and 3382 - 3384. It asserted that failure to notify the physician in a timely manner resulted in delay of care for the resident's aspiration pneumonia thereby jeopardizing the health and safety of the resident. Id. at Tr. 378.

Petitioner couches CMS's assertions as being Petitioner's alleged failure to notify Resident No. 3's treating physician of a series of episodes of elevated temperatures that began with the temperature elevation on March 30, 1999. Petitioner's post-hearing brief at 85. Petitioner argues that none of these episodes were sustained for as long as 24 hours and that its own policy did not require the staff to notify a physician of elevated temperatures that prevailed for less than 24 hours. Id. at 85 - 86. Consequently, according to Petitioner, its staff conformed to Petitioner's policy and did not neglect the needs of the resident.

This argument is unpersuasive. The critical failure of Petitioner's staff - as is made clear by CMS's prima facie evidence - lay in the staff's failure to notify the treating physician of the initial very high elevated temperature on March 30, 1999 and of the associated signs of illness including vomiting. Furthermore, I am not convinced that Petitioner's subsequent failures to notify the physician of the resident's elevated temperatures were consistent with good nursing practice in view of what happened on March 30. The March 30 episode clearly was evidence that something was seriously wrong with the resident and subsequent episodes of fever - even if they were less severe than what had occurred on March 30 and even if they were for less than 24 hours' duration - were additional evidence of a serious problem that necessitated physician notification. But, even if nothing had happened after March 30, the resident's signs on that date were so alarming that the treating physician ought to have been notified.

Petitioner argues also that it closely monitored Resident No. 3 between March 30 and April 2, 1999 and that the resident did not manifest any signs of significant illness "other than the intermittent elevated temperatures." Petitioner's post-hearing brief at 86. Petitioner evidently suggests by this assertion that there was nothing about the resident's condition that should have signaled Petitioner's staff to notify the resident's treating physician.

I disagree with this contention. The persuasive evidence introduced by CMS is that the resident's signs on March 30, 1999 were in and of themselves so serious that a physician ought to have been notified. Moreover, the resident was not by any stretch of the imagination "recovered" after that date. He continued to run intermittent fevers which subsided with the administration of Tylenol but which then recurred. The resident's treating physician acknowledged that the fact that there was no notification until the resident had run a fever intermittently for three days was a concern. P. Ex. 3, at Tr. 2913.

iv. Resident No. 4

There is no dispute that, on two separate occasions in March, 1999, Resident No. 4, an elderly individual, experienced breathing difficulties. Petitioner's staff administered oxygen to Resident No. 4 on both occasions. These episodes occurred on March 5 and 7, 1999.

CMS asserts that Petitioner's staff neglected the resident by failing to notify the resident's treating physician timely about the resident's episodes of breathing difficulties. Petitioner's staff did not notify a physician of these problems until March 8, 1999, three days after the first episode and one day after the second episode. HCFA Ex. 7, at 12 - 14; HCFA Ex. 14, at Tr. 378 - 380. CMS offered evidence to show that these episodes of breathing difficulties constituted significant changes in Resident No. 4's medical condition. HCFA Ex. 14, at Tr. 452; HCFA Ex. 19, at Tr. 3372 - 3375. CMS offered the expert testimony of a physician to show that Petitioner's staff's failure to promptly notify a physician of the resident's breathing difficulties put the resident in jeopardy. HCFA Ex. 19, at Tr. 3375.

CMS argues additionally that Petitioner neglected the resident's needs by failing to get a timely order for administration of oxygen to Resident No. 4. The evidence introduced by CMS shows no record of a physician having ordered oxygen for Resident No. 4 until March 9, 1999. CMS acknowledges that oxygen might be administered by nursing staff in an emergency without first obtaining a physician's order. But, in that event, physician approval is required for continued administration of oxygen. HCFA Ex. 13, at Tr. 341 - 344. CMS asserts that failure of Petitioner's staff to obtain immediate approval for continued administration of oxygen to Resident No. 4 violated the applicable standard. Moreover, any emergency breathing problem that the resident may have manifested made immediate notification of a physician imperative and Petitioner failed to notify a physician immediately of the problems that were being experienced by Resident No. 4.

Petitioner asserts that Resident No. 4 had experienced shortness of breath for some time "because of her kyphoscoliosis with any exertion." Petitioner's post-hearing brief at 92. Apparently, Petitioner is suggesting by this that the episodes of shortness of breath that the resident experienced in March 1999 were not significant changes in the resident's condition that necessitated immediate physician notification. I do not find this assertion to be persuasive. There is no indication in the record that the resident's previous episodes of shortness of breath necessitated administration of oxygen or that the two episodes that occurred in March 1999 were the consequence of a long-standing condition. Furthermore, Petitioner's staff plainly considered the two episodes that occurred in March 1999 to be emergencies because they administered oxygen to the resident without first obtaining a physician's order. Given that, immediate notification of a physician was imperative.

Petitioner also contends that the resident's physician was notified by telephone of the resident's condition and of the administration of oxygen to the resident on March 8, 1999 and it asserts that there is no standard requiring earlier notification. Petitioner's post-hearing brief at 92. I accept the representation that the physician was first notified on March 8, 1999. But, I do not agree with Petitioner's contention that there is no requirement that the physician be notified sooner. The resident's need for oxygen constituted an emergency condition. Under that circumstance, immediate notification of a physician is the appropriate standard. HCFA Ex. 19, at Tr. 3375

Petitioner asserts that, in retrospect, Resident No. 4's treating physician not only approved of the administration of oxygen to the resident but found that Petitioner's staff exercised good judgment in administering oxygen. Petitioner's post-hearing brief at 92. That may be so. But, this post-facto assessment begs the question of whether immediate notification of the physician of the resident's emergency condition was necessary.

v. Resident No. 6

Resident No. 6 was an elderly individual who suffered from, among other things, progressive dementia. He resided at Petitioner's facility beginning on March 25, 1999. The resident's physician saw the resident on April 7, 1999, at which time he prescribed Haldol, an anti-psychotic medication. The resident's physician next saw the resident on April 10, 1999, at which time the physician ordered that the resident be hospitalized. Resident No. 6 expired shortly afterwards.

CMS introduced prima facie evidence to show that the resident had an essentially normal physical examination on March 26, 1999. HCFA Ex. 12, at Tr. 45. But, over the next several days, the resident's physical condition deteriorated markedly. The resident had labored breathing, blue lips and nail beds, a dusky color, and he required oxygen. Id. The resident showed signs of increasing agitation. Id. Between March 27, 1999 and April 3, 1999, the resident repeatedly removed his oxygen tube or refused the administration of oxygen. HCFA Ex. 7, at 10. On April 9, 1999, the resident complained of a sore throat and exhibited symptoms of dysphagia, which worsened by the following morning.

CMS introduced evidence to show that Petitioner's staff did not notify the resident's treating physician of this marked deterioration in the resident's condition prior to April 7, 1999, when the physician first saw the resident or between April 7 and April 10, 1999, when the physician saw the resident again and ordered that he be hospitalized. HCFA Ex. 7, at 11. And, it introduced evidence to show that the failure to notify the resident's physician of these changes constituted a deviation from accepted standards of nursing practice. Id; HCFA Ex. 12, at Tr. 45 - 46; HCFA Ex. 19, at Tr. 3400 - 3401.

Petitioner did not overcome this prima facie evidence of neglect. It does not deny the failures by Petitioner's staff to notify the resident's treating physician of changes in Resident No. 6's condition. It asserts, however, that the resident's treating physician and his physician's assistants were aware of Resident No. 6's condition "because they physically saw him each day as they made rounds on the floor." Petitioner's post-hearing brief at 90. Even if that assertion is true, it would not excuse Petitioner's staff from notifying the physician of changes that they observed. After all, the resident's physician did not stay at the resident's side throughout the day and night. Moreover, the assertion that the physician or his assistants saw the resident every day is not substantiated by the record of this case. The testimony that Petitioner relies on to support the assertion is not that of the resident's physician, but that of Petitioner's Director of Clinical Services. P. Ex. 2. And, her testimony does not substantiate that the physician saw the resident every day. She testified only that the physician or his assistants would have seen the resident if they visited the resident's floor to evaluate someone else. Id. at Tr. 3319.

Petitioner asserts also that the resident's care was adequately documented in the resident's medical record. Petitioner's post-hearing brief at 90. Assuming that to be true, it does not constitute an acceptable reason not to have notified the resident's physician of significant changes in the resident's medical condition. The point is that these changes needed to be brought to the physician's attention and not just documented adequately.

b. The preponderance of the evidence establishes that Petitioner complied substantially with the requirements of 42 C.F.R. § 483.25(c).

At Tag 314 of the report of the April 22, 1999 survey, the surveyors allege that Petitioner failed to comply substantially with the participation requirement that is stated at 42 C.F.R. § 483.25(c). HCFA Ex. 7, at 14 - 17. This regulation requires that a resident who has a pressure sore or sores must receive necessary treatment and services to promote healing, prevent infection and prevent new sores from developing.

The surveyors found that Petitioner failed to comply with this requirement in providing care to Resident No. 1 (I have discussed this resident's care to some extent at Finding 8.a.i. of this decision). The undisputed facts of this case are that this resident suffered from a massive decubitus ulcer in his low back and buttocks area. This ulcer and the medical problems it caused the resident to experience may have ultimately been a cause of or a contributing factor in the resident's death.

CMS contends that Petitioner's staff failed adequately to address this pressure sore so as to promote healing. It asserts that Petitioner's staff did not deal with ongoing infection in the sore, nor did it make changes in the resident's care plan to reflect any possible changes in treatment modalities to address the sore. CMS also contends that Petitioner's staff did not document the resident's receipt or consumption of nutritional supplements. CMS's post-hearing brief at 46.

I find that the preponderance of the evidence rebuts CMS's allegation that Petitioner failed to care adequately for Resident No. 1's pressure sore. The evidence establishes that the resident had an intractable sore which had no chance of healing without surgery. P. Ex. 3, at Tr. 2576- 2577. Yet, the resident's condition precluded him from having surgery. P. Ex. 31, at Tr. 255 - 256; P. Ex. 1, at Tr. 1969 - 1970, 1994 -1995; M246; M5119. Given these facts, there was nothing that Petitioner's staff could have done which would have promoted healing of the sore.

The care that Petitioner's staff gave to the resident was adequate in light of the resident's condition and the assessment of the resident by his treating physician. The physician testified that his goal was simply to keep the wound area clean and to decrease the frequency of infection in light of the sore's intractable status. However, the resident's clinical condition made absolute prevention of infection impossible. P. Ex. 3, at Tr. 2577. Preventing infection was particularly difficult in light of the location of the sore and the resident's frequent episodes of incontinence. P. Ex. 3, at Tr. 2578. As a consequence, additional revisions to the resident's care plan would not have caused the wound to improve. Id. Moreover, the surveyors' findings that the resident's intake of supplements was not documented is refuted by facility records which show documentation of supplement intake. M238 - M312.

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 April 1999 survey the surveyors alleged that Petitioner failed to comply substantially with the requirements of 42 C.F.R. § 483.25(h)(2). HCFA Ex. 7, at 17 - 22. This regulation requires that a facility must ensure that each of its residents receives adequate supervision and assistance devices to prevent accidents.

The allegations of noncompliance are based on the care that Petitioner provided to residents who are identified in the survey report as Residents Nos. 5, 6, and 7. Essentially, the surveyors assert that Petitioner's staff failed adequately to supervise or monitor these residents to prevent them from experiencing falls.

The evidence introduced by CMS concerning the care that Petitioner gave to the three residents is prima facie evidence of noncompliance by Petitioner with the requirements of 42 C.F.R. § 483.25(h)(2). Each of these residents was an individual who was prone to falling and Petitioner's staff either knew or should have known about the risks for falling that these residents manifested. Yet, the prima facie evidence introduced by CMS shows that Petitioner's staff failed to: document adequately the residents' risk for falling; plan adequately to prevent the residents from falling; investigate adequately the care that residents received which may have resulted in the residents sustaining falls; or, monitor adequately the residents to assure that they did not fall.

I find that Petitioner failed to rebut this evidence by the preponderance of the evidence. The specific examples of inattentiveness to residents' needs which Petitioner did not rebut, when evaluated collectively, establish a persuasive case that Petitioner did not provide adequate supervision to its residents.

i. Resident No. 5

It is undisputed that Resident No. 5 was an elderly individual who was admitted to Petitioner's facility on March 5, 1999 following a fall. The fall had caused the resident to sustain a fracture to her left hip. The resident was weight bearing at the time of her entry into Petitioner's facility. However, on March 14, 1999, an orthopedist noted changes on an x-ray of the resident's hip and the resident's status changed to non-weight bearing. On March 22, 1999, the resident was discharged to the hospital for repair of a new hip fracture and a new hip replacement.

CMS introduced prima facie evidence to show that, on March 14, 1999, the resident told her orthopedic surgeon that she had fallen on that date. HCFA Ex. 7, at 20; HCFA Ex. 12, at Tr. 69. This fall was determined to have caused the screw that had been placed to repair the initial fracture to the resident's hip to shift. Id. Ultimately, a hip replacement was necessary to repair the damage sustained by the resident. HCFA Ex. 7, at 21; HCFA Ex. 12, at Tr. 70. CMS introduced evidence to show that Petitioner did not conduct an investigation of the episode that resulted in the re-injury until after the resident reported the episode to her physician. Id. Nor did Petitioner's staff develop a care plan to prevent the resident from sustaining future injuries. HCFA Ex. 12, at Tr. 71.

Petitioner contends that the resident did not fall, but, rather, that the resident's legs gave out during a transfer of the resident resulting in the staff lowering the resident to the floor. Petitioner's post-hearing brief at 100. Petitioner contends that after the resident's return from her visit to the physician on March 14, 1999, the resident "was reassessed and her fall risk assessment was changed to reflect the use of a Hoyer lift, to decrease her chances for fall." Id.

I find these assertions not to be persuasive. First, the resident plainly sustained an "accident" within the meaning of 42 C.F.R. § 483.25(h)(2) however Petitioner characterizes the events that caused Resident No. 5 to be injured. The common and ordinary meaning of an "accident" is an unintentional and undesired happening. The Random House College Dictionary, 1973 Ed. Either a fall or inadvertent twisting of the resident's leg while the resident was lowered to the floor satisfies this definition of an "accident."

Second, the record is devoid of any evidence that Petitioner's staff reacted to the resident's accident until after the resident reported it to her treating physician. Thus, although the resident sustained an accident that caused her a severe injury, and that accident occurred in the presence of Petitioner's staff, the staff was inattentive to the accident and did nothing to prevent recurrence or similar events until the accident was reported.

ii. Resident No. 6

I discuss Resident No. 6's condition and treatment by Petitioner above, at Finding 8.b.5. There are additional undisputed facts that are relevant to my analysis of this resident's condition under this part. It is undisputed that this resident exhibited both progressive dementia and an abnormal gait. The resident sustained frequent and numerous falls. Between March 30, 1999 and April 7, 1999, the resident fell on eight separate occasions. HCFA Ex. 7, at 21.

CMS alleges that Petitioner failed to provide Resident No. 6 with adequate supervision to prevent the resident from falling. It supports this allegation with the following prima facie evidence:

• The resident's treatment records document that the resident was unable to follow directions or understand fall risks. HCFA Ex. 7, at 21. Yet, Petitioner's staff attempted to address the resident's many falls by instructing the resident to not attempt to ambulate or be transferred without assistance and reminding the resident that he should not transfer himself alone. Id. This was ineffective care due to the resident's dementia. HCFA Ex. 19, at Tr. 3405 - 3406.

• The resident's care plan was not modified to address the resident's falling problem despite the resident's many falls. HCFA Ex. 7, at 22. Petitioner's staff made no assessment of the resident to address the resident's falling problem aside from noting in the resident's initial care plan that the resident was at risk for sustaining falls. Id.

In its response to CMS's allegations, Petitioner documents various actions that its staff took to address Resident No. 6's numerous falls. Petitioner's post-hearing brief at 90. The interventions that Petitioner's staff allegedly took included use of a buddy cushion, a bed alarm, bed side rails, placing the resident's bed at the nurse's station, use of a lounge chair, and use of a low bed. Id.; M2348 - 2360; P. Ex. 12, at Tr. 2454. I accept as true Petitioner's representations of the actions it took in the case of Resident No. 6. But, these actions do not respond directly or adequately to CMS's allegations of noncompliance. What was lacking here was a failure by Petitioner's staff to assess comprehensively the resident's needs. It is possible that nothing more could have been done by Petitioner's staff to prevent the resident's falls. But, how was Petitioner or its staff to know that if the staff did not review systematically the resident's situation and if planning was not done to react to the resident's obvious failure to respond to the care that was being given to him?

Furthermore, some of the interventions that Petitioner's staff implemented plainly made no sense. It was pointless, for example, to explain to the resident that he should not attempt to transfer himself in light of his inability to follow directions or understand fall risks.

iii. Resident No. 7

The undisputed facts establish that Resident No. 7 was an elderly, demented individual who was admitted to Petitioner's facility on December 18, 1998 for rehabilitation following repair of a right hip fracture that was sustained as the result of a fall. CMS's post-hearing brief at 64. The resident sustained two falls in December 1998 while residing at Petitioner's facility. An x-ray of the resident's right hip made on January 26, 1999 showed that the resident had an unstable fracture with shortening and impaction. Id. The resident's physician ordered that the resident not bear weight on the hip for a period of six weeks. However, the resident continued to attempt to ambulate. Resident No. 6 fell again on March 13, 1999 and on March 21, 1999. On March 21, 1999, the resident was hospitalized with a new fracture of her left hip. Id. at 64 - 65.

CMS offered prima facie evidence to show that Petitioner failed to provide Resident No. 7 with adequate supervision to prevent the resident from sustaining accidents. Petitioner's staff did not conduct assessments of the resident to determine the resident's risks and to decide on appropriate preventive measures. HCFA Ex. 12, at Tr. 66 - 68; HCFA Ex. 19, at Tr. 3391 - 3395. Nor did Petitioner's staff modify the resident's care plan to address the resident's frequent falls. Id.

Petitioner responds to these allegations with a litany of the actions it took to assist Resident No. 7. These include recitation of: the comprehensive initial assessment and care planning that it did for the resident; and, the various measures that the staff undertook to protect the resident from falling. Petitioner's post-hearing brief at 97 - 99. However, these assertions do not address CMS's allegations of noncompliance.

CMS's allegations center on Petitioner's failures to assess and plan for the care to be given to Resident No. 7 after its initial evaluation of the resident and once the resident's fall risks were apparent so as to understand the reasons for her falling and to prevent her from falling again. The fact that the staff may have been diligent in addressing the resident's needs and may have considered the resident's falls as a potential risk in the initial care plan it prepared for the resident is not really an answer to these allegations. Resident No. 7 was an individual who clearly was at risk for falling as is evident from: the fall which predated the resident's arrival to Petitioner's facility; the two falls that the resident sustained in December 1998 while residing at Petitioner's facility; and the resident's dementia and noncompliance with instructions. The point made by CMS, which I find to be unrebutted, is that Petitioner did not do follow up comprehensive planning to address the resident's known risk for sustaining falls once that risk became apparent to Petitioner's staff and after it became obvious that the initial plan that was developed for the resident was inadequate. In particular, Petitioner failed to plan to account for the resident's dementia and noncompliance with directions. The resident's care plan was not revised to address the resident's falls and the reasons for them between December 1998 and March 1999.

d. CMS did not establish a prima facie case that Petitioner failed to comply substantially with the requirements of 42 C.F.R. § 483.75(l)(1).

At Tag 514 of the report of the April 1999 survey, the surveyors alleged that Petitioner failed to comply substantially with the requirements of 42 C.F.R. § 483.75(l)(1). HCFA Ex. 7, at 24 - 32. This regulation requires that a facility must maintain clinical records on each of its residents in accordance with accepted professional standards and practices. The records must be: complete; accurately documented; readily accessible; and, systematically organized.

CMS asserted that Petitioner's record keeping system failed to comply with the requirements of this regulation. CMS alleges that Petitioner's staff failed to maintain clinical records in accordance with accepted professional standards for five residents who are identified in the report of the April 1999 survey as Residents Nos. 1, 2, 3, 4, and 6.

The report of the April 1999 survey made an additional allegation about Petitioner's document retention system. That is that the system allowed an entry to a record to be altered for up to 24 hours after an entry was made. HCFA Ex. 7, at 31. I assume that this alleged flaw in Petitioner's record-keeping system was cited because the surveyors felt that it jeopardized the integrity and accuracy of the entire system. CMS did not offer any arguments concerning this alleged deficiency in its post-hearing brief. See CMS's post-hearing brief at 84 - 86. Petitioner did address this issue in its post-hearing brief. Petitioner's post-hearing brief at 102 - 104. Notwithstanding, CMS again failed to address the issue in its post-hearing reply brief. See CMS's post-hearing reply brief at 35. I conclude that CMS abandoned this issue in light of its failure to make any arguments addressing it and, therefore, I do not address it here.

CMS failed to establish a prima facie case that Petitioner failed to comply with the requirements of 42 C.F.R. § 483.75(l)(1). The surveyors obtained ample evidence that certain events in the care of the residents whose care is at issue were not documented or were not documented in detail. HCFA Ex. 7, at 24 - 32. But, what is lacking, both in the survey report, and in CMS's supporting evidence and arguments, is any discussion of what are the professional standards and practices that a facility must adhere to in order to be in compliance with the requirements of 42 C.F.R. § 483.75(l)(1). In the absence of such discussion, it is not possible to say whether the lack of documentation that the surveyors found actually failed to comply with accepted professional standards and practices.

The regulation does not specify objective standards of documentation to which a facility must comply. That is not to say that the regulation is defective. Although it fails to spell out precisely what a facility must do in order to maintain adequate documentation of residents' records, it tells facilities that they must comply with "accepted professional standards and practices.

In this case, neither the New York State survey agency nor CMS ever identified those standards. The survey report merely recites the gaps in Petitioner's documentation and then leaps to the conclusion that Petitioner was not complying with the requirements of the regulation. For example, with respect to Resident No. 2, the report asserts that:

There is no complete clinical picture of the resident described in either the nursing notes or physician notes to indicate that treatment of . . . [the resident's] change of condition had been discussed or that the resident's death was anticipated.

HCFA Ex. 7, at 26. Assuming that to be true, the report does not identify a standard which would require that a facility maintain records which address such subjects.

CMS did nothing to cure the failure of the survey report to identify the standards with which Petitioner allegedly failed to comply. CMS might have identified the criteria against which to measure the documentation that was maintained by Petitioner. See CMS's post-hearing brief at 85 - 87. But, CMS simply asserts, with respect to each resident whose care is at issue, that Petitioner failed to comply with unspecified standards.

e. Petitioner did not prove that it complied substantially with the requirements of 42 C.F.R. § 483.75.

At Tag 490 of the report of the April 1999 survey the surveyors alleged that Petitioner failed to comply substantially with the requirements of 42 C.F.R. § 483.75. HCFA Ex. 7 at 22 - 23. This regulation requires that a facility must be administered in a manner that enables it to use its resources effectively and efficiently in order to attain or maintain the highest practicable physical, mental, and psychosocial well-being of each resident.

The allegations of noncompliance that are made at Tag 490 derive from the allegations of noncompliance that are made at the other tags of the survey report, including Tags 224, 314, 324, and 514. Essentially, CMS asserts that Petitioner's alleged failures to comply with the requirements that underlie these other tags is prima facie evidence of Petitioner's alleged failure to be administered efficiently and effectively.

I have found that Petitioner did not comply with some of the participation requirements for which it was cited as being deficient in the report of the April 1999 survey. Above, at Finding 8.a. and 8.c., I conclude that Petitioner did not prove that it was complying substantially with the requirements that underlie Tags 224, and 324. I conclude at Finding 8.b. that Petitioner proved it complied substantially with the requirements that underlie Tag 314. I also conclude at Finding 8.d. that CMS did not establish a prima facie case that Petitioner failed to comply substantially with the requirements that underlie Tag 514.

I sustain CMS's allegations concerning Tag 490. The unrebutted prima facie evidence of Petitioner's noncompliance under Tags 224 and 324 is sufficient to show that Petitioner was not administered efficiently and effectively consistent with the requirements of 42 C.F.R. § 483.75.

The picture that emerges from Petitioner's noncompliance with Tags 224 and 324 is of a facility whose staff was inattentive in key respects to the needs of residents. There are documented failures by Petitioner's staff to: assess the needs of residents; plan residents' care; contact residents' physicians about significant adverse changes in residents' conditions; and, to guard residents against sustaining accidents. When viewed in its totality the evidence shows Petitioner to have been an ineffectively run and inefficient facility.

The fact that I have not found Petitioner to have been deficient under Tags 314 and 514 is not a basis for me to find that Petitioner was not deficient under Tag 490. Findings of deficiency under Tags 314 and 514 would be an additional basis to find that Petitioner was noncompliant under Tag 490, but they are not necessary for me to reach that conclusion. The evidence of Petitioner's noncompliance under Tags 224 and 324 is sufficient for me to conclude that Petitioner was ineffectively run and inefficient.

f. CMS failed to establish a prima facie case that Petitioner did not comply substantially with the requirements of 42 C.F.R. § 483.75(d)(1) - (2).

At Tag 493 of the report of the April 1999 survey, the surveyors alleged that Petitioner failed to comply substantially with the requirements of 42 C.F.R. § 483.75(d)(1) - (2). HCFA Ex. 7, at 23 - 24. The regulation requires a facility to have a governing body or designated persons who function as a governing body that is legally responsible for establishing and implementing policies regarding the management and operation of the facility. The regulation provides further that the governing body appoints the facility's administrator, who is licensed by a State where State licensing is required, and who is responsible for the management of the facility.

The surveyors concluded that Petitioner had not complied substantially with the requirements of the regulation because:

it was determined that the governing body has not established and implemented policies to assure the effective management and operation of the facility.

The surveyors then cited Petitioner's alleged failures to comply substantially with participation requirements as alleged in Tags 224, 314, 324, and 514, as an evidentiary basis for this conclusion.

I find that these assertions of noncompliance fail to state a prima facie case of noncompliance with the requirements of 42 C.F.R. § 483.75(d)(1) - (2). That is because neither the surveyors nor CMS offered any evidence to show that Petitioner's management structure failed to conform to the regulatory requirements. And, the evidence that is cited in the survey report - which addresses how effectively Petitioner's management functioned - is irrelevant to the compliance requirements stated at 42 C.F.R. § 483.75(d)(1) - (2).

The regulation establishes requirements which address the management structure of a skilled nursing facility. It requires that the facility establish certain entities and positions in accordance with the requirements of State laws. But, the regulation says nothing about the implementation of policies by a facility's management. Here, the allegations and the evidence that the surveyors identified fail to speak at all about Petitioner's management structure. They address only the question of how effectively Petitioner's management functioned.

9. The New York State survey agency was authorized to impose a directed plan of correction against Petitioner which addresses the deficiencies that are alleged at Tags 224, 324, and 490 of the April 1999 survey report.

My Findings that Petitioner was not complying substantially with the participation requirements that are stated under Tags 224, 324, and 490 of the April 1999 survey report means that the New York State survey agency was authorized to impose a directed plan of correction that addressed those elements of noncompliance. The New York State survey agency was not authorized to impose a directed plan of correction with respect to the allegations made at Tags 314, 493, and 514 of the April 1999 survey report inasmuch as I do not sustain the deficiency allegations that were made under these tags.

I make no Findings in this decision concerning which specific elements of the directed plan of correction may be implemented and which may not be implemented. See HCFA Ex. 2. A determination as to how to implement the directed plan of correction - assuming it not to be moot - is up to the New York State survey agency. I have no authority to look at specific elements of a remedy and to decide whether those elements are appropriate. I leave it to the New York State survey agency to determine how the plan must be modified in light of my decision.

JUDGE
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Steven T. Kessel

Administrative Law Judge

FOOTNOTES
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1. CMS was formerly called the Health Care Financing Administration (HCFA) during the pendency of Petitioner's prior appeal. Therefore, I will continue to refer to exhibits presented by HCFA (now CMS) as HCFA exhibits (HCFA Ex.).

2. I have had to do a substantial amount of work that may turn out ultimately to be unnecessary in order to comply with the panel's remand of this case. As the panel acknowledged in its decision, my Findings as to the April 1999 survey will be moot if the panel ultimately sustains my Findings as to the June 1999 survey. Yet, the panel remanded this case to me, in part, because it decided that the allegations as to the April 1999 survey might not be moot if it subsequently decided to reverse my Findings as to the June 1999 survey. Of course, it could be said about any finding of mootness that the finding might not be moot if the premise that underlies the finding is subsequently overturned. On that logic, nothing would be moot and the work responsibilities of administrative law judges would grow substantially as they addressed issues that might not be moot.

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