By ruling dated August 11, 1998,⁽¹⁾ I had denied a motion for summary judgment filed by the Health Care Financing Administration (HCFA). My ruling was based primarily on ambiguities in HCFA's motion concerning the relationship between the survey findings for one resident and the civil money penalty (CMP) totaling $8,600 it imposed against Petitioner for 52 days.⁽²⁾ As the moving party, HCFA had failed to establish the absence of all genuine issues of material fact or its entitlement to judgment as a matter of law. Accordingly, my ruling denying the summary judgment motion also directed the parties to clarify their positions on certain issues, in order to ensure that the case proceeds to an evidentiary hearing only on genuine disputes of material fact.

Subsequently, HCFA obtained leave to file a renewed motion for summary judgment. HCFA filed a memorandum in support of its renewed motion that addressed the problems and questions I had identified in my August 11, 1998 ruling. Petitioner was given the opportunity to file a written response and establish the validity of its argument that an evidentiary hearing would be necessary.

In deciding the renewed motion from HCFA, I have incorporated into this Decision the relevant discussions of the procedural history, undisputed facts, and legal interpretations set forth in my August 11, 1998 ruling. I am mindful that any evidence provided in connection with a summary judgment motion should be read in the light most favorable to the non-moving party. However, I have used for guidance also the following portion of Rule 56 of the Federal Rules of Civil Procedure:

(e) . . . .

When a motion for summary judgment is made and supported as provided in this rule, an adverse party may not rest upon the mere allegations or denials of the adverse party's pleading, but the adverse party's response, by affidavit or otherwise provided in this rule, must set forth specific facts showing that there is a genuine issue for trial. If the adverse party does not so respond, summary judgment, if appropriate, shall be entered against the adverse party.

Fed. R. Civ. P. 56(e).

As explained in the accompanying Advisory Committee Notes, the foregoing two sentences of subsection (e) were intended to make clear that the "very mission of the summary judgment procedure is to pierce the pleading and to assess the proof in order to see whether there is a genuine need for trial."

Having considered the parties' submissions for HCFA's renewed motion,⁽³⁾ I hereby grant HCFA's motion for summary affirmance.

The numbered rulings below encompass the relevant findings and conclusions.

DISCUSSION

Acting in accordance with the directives in my August 11, 1998 ruling, HCFA has made clear with its renewed motion that it is using only one group of survey findings (i.e., those that were made pursuant to 42 C.F.R. � 483.25(h)(2)) to support the entire duration of the CMP remedy imposed against Petitioner. The CMP was imposed for the 52 days extending from September 1, 1997 until and including October 22, 1997. The relevant part of the regulation relied upon by HCFA requires that all Medicare-certified facilities like Petitioner--

must ensure that

. . .

(2) Each resident receives adequate supervision and assistance devices to prevent accidents.

42 C.F.R. � 483.25(h)(2)(emphasis added).

HCFA has made clear also with its renewed motion that it is using the information from Petitioner's own records for four of its residents in order to demonstrate that Petitioner had remained out of compliance with the requirements of 42 C.F.R. � 483.25(h)(2) for the 52-day period. HCFA has the unreviewable discretion to impose a CMP as a remedy for any days of noncompliance. 42 C.F.R. �� 488.430, 488.438(e)(2). The allowable rates of CMP are set by regulation at 42 C.F.R. � 488.438(a). In this case, HCFA imposed a CMP of $3,050 for the first two days of the 52-day period, and $50 per day for the remaining days.

For the first two days of the 52-day period, HCFA is relying only on information relating to one resident, Ralph L.,⁽⁴⁾ who left Petitioner's facility unnoticed on September 1, 1997, and was not found or returned to the facility until September 2, 1997. HCFA asks that I summarily affirm its findings that Ralph L.'s situation demonstrates Petitioner's noncompliance with 42 C.F.R. � 483.25(h)(2) on September 1, 1997 and September 2, 1997, and that said noncompliance had arisen to the level of "immediate jeopardy" to Ralph L. on those two days. Because a CMP rate of at least $3,050 per day must be sustained if HCFA's immediate jeopardy determination is not clearly erroneous (42 C.F.R. � 488.438(a)(1) and (e)(1), 42 C.F.R. � 498.60(c)(2)), HCFA is therefore asking me to summarily affirm the CMP of $3,050 per day imposed for the initial two days of the 52-day period.

As for the remaining 50 days for which HCFA has imposed $50 per day against Petitioner, HCFA's renewed motion for summary affirmance makes clear that it is using the information concerning three other residents to show that Petitioner continued to be out of compliance with 42 C.F.R. � 483.25(h)(2) even after the immediate jeopardy situation for Ralph L. had been abated. According to HCFA, omissions under the regulation are shown by Petitioner's own records for these other residents, and the potential for causing them more than minimal harm is the logical conclusion inherent from Petitioner's own records. HCFA argues that, if I should find in its favor on the issue of Petitioner's continued noncompliance with 42 C.F.R. � 483.25(h)(2), then I must summarily affirm also the $50 per day imposed for the period from September 3, 1997 until and including October 22, 1997.⁽⁵⁾

Ruling 1:

A. I grant summary affirmance for HCFA's determination that Petitioner was out of compliance with the requirements of 42 C.F.R. � 483.25(h)(2) from September 1, 1997 through September 2, 1997;

B. consequently, I conclude as a matter of law that HCFA had a basis for imposing the CMP remedy against Petitioner for those two days.

In responding to HCFA's renewed motion, Petitioner had the opportunity to re-assert the affirmative defense that, because no legal guardian had been appointed under Ohio law, Ralph L. (Resident 175) had the right or prerogative to leave Petitioner's facility unnoticed and at will -- and, therefore, Petitioner was unable to comply with the supervision requirements of 42 C.F.R. � 483.25(h)(2). However, I had cautioned Petitioner to proceed cautiously, and with consideration of the relevant facts. Ruling, at 10.

I warned Petitioner, in my August 11, 1998 ruling, that I may find its theories with respect to Ralph L. untenable as a matter of law. My basis for warning Petitioner was that, even if Ralph L. had the mental capacity to make the choices alleged by Petitioner, Petitioner cannot abdicate its responsibility to provide adequate and appropriate supervision to that resident for the purpose of ensuring that he would make and effectuate his choices safely, without placing his health and safety at risk for more than minimal harm. Id. I informed Petitioner also that when I considered the health and safety issue for Ralph L., I would not overlook Petitioner's own evidence that, even according to a psychologist's opinion which was apparently obtained by Petitioner in support of its opposition to HCFA's motion for summary judgment, Ralph L. was prone to losing his way and had a responsibility level equivalent to that of a 10-year-old or 12-year-old child. Id.⁽⁶⁾ Additionally, I advised Petitioner that I would consider, with respect to the health and safety issue, the fact that Petitioner's own records establish that the assistance of the police had been requested to locate Ralph L. after his absence was noticed on the evening of September 1, 1997, that Petitioner was unable to ascertain this resident's whereabouts for 14 hours, and that this resident was finally located on the second day in a soybean field one and one-half miles away from the facility. Id.

At the same time, I also alerted Petitioner to its right to interpose an affirmative defense on the basis of any precautions or actions it had taken pursuant to 42 C.F.R. � 483.25(h)(2). I noted that this regulation does not impose strict liability upon the facility if its resident should leave it unnoticed or unsupervised by that facility. Ruling, at 8. To determine compliance with this regulation, the relevant inquiry is whether Petitioner's supervision (of whatever nature and whatever degree) was "adequate" for the resident's situation. Id. I did not reach the issue of "immediate jeopardy" for Ralph L. in my prior ruling because the parties' submissions for HCFA's initial motion were not sufficient for me to resolve the threshold adequacy of supervision issue. Id. Without a resolution to that threshold issue, I was unable to decide whether Petitioner was even out of compliance with the requirements of 42 C.F.R. � 483.25(h)(2); therefore, I was also unable to decide whether the unproven noncompliance had occurred at the "immediate jeopardy" level. Id. In this manner, Petitioner was made aware of the importance of disclosing the degree, nature, and appropriateness of the supervision, if any, it had provided to Ralph L. during the relevant time period.

In its brief opposing HCFA's renewed motion for summary disposition, Petitioner does not re-assert the proposition that the facility had a legal duty to allow Ralph L. to depart unnoticed, unsupervised, and at will. Nor does Petitioner dispute HCFA's conclusion that, as a matter of law, Ralph L. must be found to have been without any supervision by Petitioner during the hours he was missing from the facility on September 1-2, 1997. See HCFA Br., at 5. Petitioner also does not challenge the truth of the information quoted by HCFA from those records Petitioner had generated for Ralph L. prior to September 1, 1997. Id., at 2-5.

HCFA quoted information which includes Petitioner's written assessments and notes of late August 1997, showing Petitioner's awareness that Ralph L. had a history of "wandering" away from another nursing home even before he was admitted by Petitioner on August 20, 1997, immediately following his hospitalization for intra cranial hemorrhage. Such information also revealed: that Ralph L. had long-term and short-term memory deficits, as well as limited awareness of his environment and lack of orientation to time, date, season, or location; that during the ten days following his admission to Petitioner's facility, Petitioner had noted Ralph L.'s significant improvement in his ambulation skills; that only a few days before September 1, 1997, Ralph L. had removed the alarm placed on his arm, emerged from the wheelchair which had an alarm, and attempted to walk out Petitioner's front door; and, that Petitioner had identified on August 29, 1997, the need to address "RISK -- injury to self or others d/t [i.e., due to] wandering." HCFA Br., at 5.

Nor does Petitioner dispute the truth of HCFA's assertions that information from Petitioner's own records shows that, on the evening of September 1, 1997, it had notified the local police that Ralph L. was missing; that neither the police, Petitioner, nor anyone else had been able to find Ralph L. until approximately 3:00 PM on September 2, 1997; that when found, Ralph L. was in a soybean field more than one mile from Petitioner's facility; that his arms and face were sunburnt, and his body had multiple mosquito bites; and, that Petitioner's facility is located within a mile of a shopping mall, a busy thoroughfare, and a State highway. See HCFA Br., at 3-4.

Instead, Petitioner contends in opposition to HCFA's renewed motion that,

on previous occasions of having left the facility [,] [Ralph L.] would go across two State highways and an interstate highway to a truck stop to get coffee and cigarettes without any harm occurring to himself. Heath is aware that the local deputy sheriff knew Resident 175 [i.e., Ralph L.] well enough to routinely return him from the truck stop.

Pet. Resp., at 2. These contentions are consistent with Petitioner's earlier statements that, if this case were to proceed to an evidentiary hearing, Petitioner would endeavor to prove the following:

On August 31, 1997, his physician wrote an order that he was no longer to be permitted to smoke and the resident expressed hostility to that physician and to the facility staff for following that physician's order. He expressed a desire to leave the facility rather than comply with the physician's order. On September 1, 1997, Resident 175 [Ralph L.] continued to express anger at not being permitted to smoke [,] which resulted in staff intervention with then apparent success. Subsequently, Resident No. 175 surreptitiously left the facility, apparently knowing that he would be redirected if he announced the intention to do so again. Conversation with staff at a prior nursing facility that he had resided in revealed that he routinely left the facility to go to a truck stop for cigarettes and coffee and to a friend's house to visit. When Resident No. 175 was located he had no injury and stated his intention to not leave any further. Such has indeed been his practice since the episode in question. It is the position of Heath, following testimony and evidence to substantiate the foregoing, that there was no "accident" and thus no deficiency under Tag No. F-324 [referring to 42 C.F.R. � 483.25(h)(2)] with respect to Resident No. 175.

Heath Nursing and Convalescent Center's Statement of Readiness (Pet. Readiness Statement), dated September 9, 1998, at 4 (emphasis added).

As further support for its alleged compliance with the regulatory requirements, Petitioner directs attention to the following sentence of a psychologist's letter dated April 16, 1998:

In general, [Ralph L.'s] awareness of danger and ways to protect himself are intact.

Pet. Resp., at 2.⁽⁷⁾

Applying the guidelines provided by Fed. R. Civ. P. 56(e), to the foregoing statements from Petitioner, I find that virtually all of those statements lack the evidentiary support necessary to be considered valid responses to HCFA's renewed motion. Whereas HCFA has supported its position with citations to undisputed information of record, Petitioner has taken the approach that it has disagreements with HCFA's conclusions and that the merits of those disagreements will be shown later at an evidentiary hearing. Petitioner's approach does not defeat HCFA's properly supported renewed motion. Additionally, even if all of the foregoing statements by Petitioner were accepted as true, they would not support any legally valid interpretation of the relevant regulations, and they would create no genuine dispute of material fact for further proceedings.

First, the uncontested facts of record do not permit the inference that Petitioner had Ralph L. under supervision while he was at large outside the facility during the afternoon or evening of September 1, 1997, until he was found on the afternoon of September 2, 1997. During the time he was away from the facility without supervision, Ralph L. still had the legal status of being one of Petitioner's residents. The gravamen of HCFA's renewed motion is that, for a significant period of time on September 1-2, 1997, Petitioner did not know the whereabouts of Ralph L. HCFA Rep., at 3-5. Therefore, during the period Ralph L. was missing from the facility, Petitioner did not effectuate (and could not have effectuated) its duty to provide Ralph L. with the type and degree of supervision adequate for preventing accidents to him.

As for Petitioner's efforts to create issues concerning the events preceding Ralph L.'s unnoticed and unsupervised departure on the afternoon or evening of September 1, 1997, Petitioner had been advised in my August 11, 1998 ruling to focus on the issue of whether its supervision efforts for this resident should be considered adequate in light of the relevant circumstances. However, Petitioner does not cite any information in its brief which would disclose, for example, what actions, if any, were undertaken by its staff to satisfy the requirements of 42 C.F.R. � 483.25(h)(2) after they saw that Ralph L. had removed the alarm on his arm, discarded the wheelchair equipped with an alarm, and attempted to walk out of the facility prior to his successful departure. It has not disputed HCFA's showing that before and during September 1, 1997, Petitioner knew that the use of alarms for Ralph L. could prove ineffective. Petitioner does not even allege that on the afternoon or evening of September 1, 1997, when Ralph L. succeeded in leaving the facility unnoticed, its staff had in place any alternative or additional safeguards to supervise his safety in response to this resident's known tendency and desire to leave the facility. Even if I were to assume as true Petitioner's assertion that, sometime prior to September 1, 1997, "Resident 175 [Ralph L.] continued to express anger at not being permitted to smoke [,] which resulted in staff intervention with then apparent success[,]" (Pet. Readiness Statement, at 4), that assertion does not disclose in what manner or to what extent supervision, if any, was being provided by Petitioner to Ralph L. when he successfully left the facility unnoticed.

Petitioner's responses to HCFA's renewed motion appear to disregard the fact that the regulation had placed upon Petitioner the duty to supervise its own residents. As noted above, Petitioner wishes to defend itself at an evidentiary hearing by showing that Ralph L. was at fault because he chose to leave the facility "surreptitiously," that he has not suffered (and was not likely to suffer) any actual harm as a result of his unsupervised trips across various highways, and that HCFA was barred from finding Petitioner out of compliance with 42 C.F.R. � 483.25(h)(2) because Ralph L. had not suffered any accident. Pet. Readiness Statement, at 4. The legal propositions Petitioner seeks to support with these asserted facts are untenable as a matter of law. Therefore, whatever the truth of the matters asserted by Petitioner, they would create no genuine dispute of material fact.

Actual harm is not necessary to a finding of noncompliance. Rather, the potential for more than minimum harm to a resident's health or safety is the standard. 42 C.F.R. � 488.301. Additionally, 42 C.F.R. � 483.25(h)(2) refers to the facility's obligation to prevent accidents for its residents (emphasis added). As a resident of Petitioner's nursing home, Ralph L. was the intended beneficiary of the Medicare laws and within the class of people protected by 42 C.F.R. � 483.25(b)(2). This regulation placed a duty on the facility to protect its residents in a certain manner; it did not place that obligation on the residents themselves or on local law enforcement officials.

When evaluated against these correct interpretations of the regulations, Petitioner's assertions of fact are of no legal significance even when they are presumed true. I note as examples Petitioner's assertions that "on previous occasions of having left the facility[,] [Ralph L.] would go across two State highways and an interstate highway to a truck stop to get coffee and cigarettes without any harm occurring to himself,"⁽⁸⁾ and that the local deputy sheriff knew this resident well enough to routinely return him from the truck stop.⁽⁹⁾ For this discussion, I leave aside the undisputed facts that, for a period of many hours on September 1-2, 1997, no one could locate Ralph L. Nor was Ralph L. found at the truck stop described by Petitioner.

For reasons which should be obvious, Petitioner's obligations to Ralph L. on September 1 and 2, 1997, have not been discharged by a deputy sheriff's past practice of returning Ralph L. to Petitioner after this resident has crossed three major highways without supervision. The fact that Ralph L. had not been injured or killed while crossing those two State highways and one interstate highway described by Petitioner does not imply that the absence of supervision by Petitioner constituted compliance with 42 C.F.R. � 483.25(h)(2), or that there existed no risk for more than minimal harm to that resident. Without regard for the fact that Ralph L's unsupervised activities away from Petitioner's facility had lasted through the darkness of night and extended into the following afternoon over locations and terrain unknown to Petitioner, the potential for serious bodily injuries is conveyed even by Petitioner's own description of this resident's prior unsupervised crossings of highways during unspecified hours. Nothing alleged or shown by Petitioner can lead to the conclusion that Ralph L. was immune from the risk of accidents, or that Petitioner was without an obligation to help prevent those accidents from occurring.

"Accidents," by definition, denote occurrences that are outside of the victim's expectations or ability to control. Petitioner was not relieved of its duty to prevent accidents, as required by 42 C.F.R. � 483.25(h)(2), because it alleges to have thought that Ralph L. had the mental wherewithal to be aware of danger and to know of the need to protect himself. See Pet. Resp., at 2. Yet, in support of an incorrect contrary proposition, Petitioner has relied on one sentence selected from the second paragraph of the "To Whom It May Concern" letter from Dr. Gorga, dated April 16, 1998. Id.

The remaining information contained in the last two paragraphs of Dr. Gorga's letter is as follows:

His memory problems are significant, however, and he is destructible. Thus, he may be prone to losing his way or forgetting to wear his glasses. I would assess his level of responsibility to be that of a ten or twelve year old child. He is unlikely to hurt himself and is able to avoid dangerous situations. At the same time, it would be preferable that he be supervised as much as possible in public places. [Ralph L.] responds very well to redirection and had adequate communication skills to express his needs to strangers.

Once Nick [a/k/a Ralph L.] can be engaged in regular activity such as janitorial work or routine labor he will be at very low risk of putting himself in harms way.

Pet. Resp., Ex. A. Additionally, Dr. Gorga stated clearly at the outset of his letter that he has evaluated Ralph L. only since October 8, 1997. Nothing in his letter can be interpreted as meaning that he was providing an opinion for Ralph L.'s condition as of September 1, 1997.

The record before me does contain assessment information generated by Petitioner itself on or shortly before September 1, 1997. Petitioner has not controverted the information in its own assessment records for Ralph L., showing Petitioner's acknowledgment on August 29, 1997, that it needed to address the potential for this resident's causing injury to himself and others due to his tendency to wander. Having unsuccessfully used an alarm on Ralph L's person and on his wheelchair prior to his unnoticed departure on the afternoon of September 1, 1997, Petitioner can hardly suggest in seriousness that, in late August and early September of 1997, it had thought inapplicable the requirements of 42 C.F.R. � 483.25(h)(2) for the prevention of accidents. Even if Dr. Gorga's opinions could be interpreted as referring to Ralph L.'s condition on September 1-2, 1997, Ralph L. would have been at low risk for putting himself in harm's way only if Petitioner had kept him occupied with regular activities. There is no indication in the record that Petitioner's supervision of Ralph L. at the relevant time had included involving him in such activities. Additionally, even accepting Dr. Gorga's opinion that Ralph L. had the ability to communicate his needs to strangers, there exists the risk of serious harm to Ralph L. if he communicates his needs to strangers who have malicious dispositions.

For all of the foregoing reasons, I grant summary affirmance in favor of HCFA on the issue of whether Petitioner was out of compliance with 42 C.F.R. � 483.25(h)(2) on September 1-2, 1997. As a consequence, I must also conclude as a matter of law that HCFA had a basis for imposing a CMP of some amount at the rate of $50 or more per day for those two days. 42 C.F.R. �� 488.430, 488.438. Where noncompliance has been established, HCFA's exercise of its discretion to impose a CMP is not subject to administrative review. 42 C.F.R. � 488.438(e)(2).

Ruling 2:

A. I grant summary affirmance for HCFA's determination that Petitioner's noncompliance with 42 C.F.R. � 483.25(h)(2) was at the level of "immediate jeopardy" to Ralph L. on September 1 and 2, 1997;

B. consequently, I must summarily affirm also the CMP of $3,050 per day assessed against Petitioner by HCFA for those two days of noncompliance.

HCFA's immediate jeopardy determination cannot be set aside unless it is clearly erroneous. 42 C.F.R. � 498.60(c)(2).

In opposing HCFA's renewed motion, Petitioner attributes to HCFA a position on "immediate jeopardy" that is not apparent from HCFA's filings to date and then argues that said position conflicts with the testimony by one of HCFA's witnesses in another case.⁽¹⁰⁾ Petitioner complains that HCFA has taken the position in this case that a facility never loses it obligation to supervise a resident even when he "may be with others,"⁽¹¹⁾ whereas the testimony of a HCFA witness in another case indicated that numerous factors would be considered in making an "immediate jeopardy" determination.⁽¹²⁾

Petitioner seeks to establish false issues by wrongly attributing arguments to HCFA. As I have already discussed above, the provisions of 42 C.F.R. � 483.25(h)(2) impose the specified duties on the nursing home that is caring for the resident in question. Those duties exist whether or not a law enforcement officer can usually find the resident after he has left the facility unnoticed, or whether the result of his unsupervised forays to the outside is to place himself in the midst of other people at a truck stop, as alleged by Petitioner. It is significant to HCFA's renewed summary judgment motion that Petitioner has presented no evidence (or even allegation) that the law enforcement officer or the people at the truck stop were Petitioner's employees. Nor is there even any hint in the record before me that such individuals were under a legal duty to assume the supervisory responsibilities imposed by law upon Petitioner.

To the extent Petitioner's references to the absence of prior injury and accidents to Ralph L. were intended to show that this resident was never in "immediate jeopardy" on September 1 and 2, 1997, I reject that conclusion. "Immediate jeopardy" means

a situation in which the provider's noncompliance with one or more requirements of participation had caused, or is likely to cause, serious injury, harm, impairment, or death to a resident (emphasis added).

42 C.F.R. � 488.301. Death or actual injury to a resident need not occur before HCFA declares an "immediate jeopardy" and imposes a corresponding amount of CMP to correct that level of noncompliance.

To the extent Petitioner's statement that Ralph L. had left its facility "surreptitiously . . . apparently knowing that he would be redirected if he announced the intention to do so again"⁽¹³⁾ was intended to show that this resident had caused his own situation on September 1 and 2, 1997, I reject this conclusion also. Petitioner has not shown that it had any precautions or supervision in effect for Ralph L. when he departed. Nothing of record even suggests that Petitioner had a policy of allowing its residents to come and go as they wished, without the use of any records, logs, or other procedures to ascertain in advance where they were going, who would be accompanying them, their mode of transportation, or the anticipated length of their absence from the facility. In deciding HCFA's renewed motion for summary judgment, I have already found above that Petitioner was out of compliance with 42 C.F.R. � 483.25(h)(2) on those two days. I emphasize again the following portion of my earlier ruling dated August 11, 1998:

[E]ven if Petitioner were able to prove that Resident #175 [Ralph L.] had the mental capacity on September 1, 1997 to knowingly decide between remaining on premise to receive treatment or departing the premise and thereby expose himself to health and safety risks, Petitioner cannot abdicate its responsibility to provide adequate and appropriate supervision to Resident #175 under 42 C.F.R. � 483.25(h)(2) for the purpose of ensuring that he would make and effectuate his choice safely, without placing his health and safety at risk for more than minimal harm.

Ruling, at 10. Therefore, HCFA's "immediate jeopardy" determination cannot be negated by Petitioner's intimation that Ralph L. had knowingly chosen to leave the facility unnoticed in order to avoid having his departure thwarted.

In the final analysis, the undisputed information of record, no matter how read, does not lead to the conclusion that HCFA's "immediate jeopardy" determination is clearly erroneous. There is no dispute that Petitioner's own records show that Ralph L.'s absence finally was reported to the police at approximately 11:00 P.M. on September 1, 1997, after a room-to-room search for him had proven unsuccessful. His whereabouts were unknown until approximately 3:00 P.M. the following day, when he was found in a soybean field more than one mile away from the facility with mosquito bites and sunburn to his body. No one knows where or how far Ralph L. had traveled during those hours, what experiences he had undergone, or whether he had escaped greater dangers than indicated by the mosquito bites and sunburns. It is also undisputed that Petitioner's facility is located within a mile of a shopping mall, a busy thoroughfare, and a State highway. These facts added together are consistent with the regulatory definition of "immediate jeopardy." Nothing that can be inferred from any fact or allegation of record indicates the possibility that HCFA's use of the "immediate jeopardy" classification for Petitioner's noncompliance on September 1 and 2, 1997 may be viewed as clearly erroneous.

For noncompliance at the "immediate jeopardy" level, HCFA cannot impose a CMP rate lower than $3,050 per day. 42 C.F.R. � 488.438(a)(1). Therefore, I summarily affirm also HCFA's imposition of $3,050 per day against Petitioner for its two days, September 1-2, 1997, of noncompliance with 42 C.F.R. � 483.25(h)(2) at the "immediate jeopardy" level.

Ruling 3:

A. I grant summary affirmance for HCFA's determination that Petitioner was out of compliance with the requirements of 42 C.F.R.� 483.25(h)(2) during September 3 through and including October 22, 1997;

B. consequently, I summarily affirm also the $50 per day CMP rate HCFA imposed for the foregoing period.

1. Summary affirmance of the noncompliance determination covering September 3, 1997 through and including October 22, 1997.

In my August 11, 1998 Ruling discussing HCFA's use of Ralph L.'s situation to support a CMP of 52 days, I had noted that the outcomes of a re-survey and an informal dispute resolution process concerning other residents had affected HCFA's determination that the CMP should end after October 22, 1997. Exactly how or why HCFA chose the end-date is not significant to the motion presently before me. After having reviewed my reasons for rejecting its initial motion for summary judgment, HCFA uses many of Petitioner's own records for three residents to demonstrate Petitioner's failure to comply substantially with 42 C.F.R. � 483.25(h)(2) from September 3, 1997 until it was deemed to have resumed compliance on October 23, 1997.

The three residents relied upon by HCFA are: Isabella M. (Resident 91), Martha M. (Resident 97), and Mae Ruth A. (Resident 4). For each of these three residents, HCFA has introduced facts to show that Petitioner had failed to provide adequate supervision or assistance devices to prevent accidents. Petitioner has again failed to support its opposition to HCFA's renewed motion for summary affirmance with the requisite showing that it has evidence that is material to the noncompliance issue.

a. Isabella M.

I summarize below the facts shown by HCFA by using its surveyors' observations and Petitioner's records concerning Isabella M. See HCFA Br., at 7-9; HCFA Rep., at 7-9.

It is undisputed that Isabella M. was a subject of the June 24, 1997 annual survey, which did not result in HCFA's imposing the CMP under review. The surveyors discovered during this survey that Isabella M. had fallen four times within the one month period between August 11, 1996 and September 11, 1996. Then in October 1996, she fractured her right hip when she fell again. Subsequently, between October 25, 1996 and May 13, 1997, Isabella M. fell 11 more times. The assessment documents generated by Petitioner on July 20, 1997, indicated that she had fallen again during the preceding 30 days.

After the June 24, 1997 survey, Petitioner was cited for various deficiencies, and Petitioner promised to correct its deficiency relating to those residents who are at risk for falling by August 13, 1997. However, on August 8, 1997, Isabella M. fell again. Petitioner responded to this fall by requesting a review of Isabella M.'s medications. The review of her medications was done on August 20, 1997, according to Petitioner's records.

An August 20, 1997 note in Petitioner's file for Isabella M. acknowledged her frequent falls and stated that the use of Haldol and three other medications (Tagamet, Bentyl, and Darvocet) may be "significant contributing factors" to those falls. See HCFA Br., at 8.

On August 21, 1997, Isabella M. fell again. A note in her file dated the following day, August 22, 1997, again acknowledged that she was at high risk for falls and that the use of Haldol may be a significant contributing factor. See HCFA Br., at 8.

On August 26, 1997, Petitioner discontinued Isabella M.'s prescription for Tagamet, one of the four medications which had been contributing to her falls. Pepcid was substituted for Tagamet. Haldol was not discontinued. See HCFA Br., at 8.

HCFA contends that, as a matter of law, Petitioner's efforts to prevent accidents for Isabella M. were inadequate within the meaning of 42 C.F.R. � 483.25(h)(2) because Petitioner had unjustifiably delayed its exploration of the causes for this resident's falls, as well as unjustifiably delayed its implementation of needed responses, such as substituting Tagamet for Pepcid. HCFA Rep., at 8. However, this regulation refers only to the provision of adequate "supervision" and "assistance devices" for the prevention of accidents. Whether or not there had been adequate efforts to change medications and conduct assessments in a more timely manner, these endeavors do not, by themselves, fit within the definition of "assistance devices" or "supervision." Nor is the medication Haldol, whether its use was continued or discontinued, an assistive device or a method of supervision within the meaning of the regulation.

Therefore, in considering HCFA's renewed motion for summary affirmance under 42 C.F.R. � 483.25(h)(2), I have focused on the question of whether anything cited by either party indicates that, once Petitioner learned of the relationship between Haldol and this resident's risk for falls, it responded to that knowledge by actually providing (or evaluating the need to provide) appropriate supervision or assistive devices to Isabella M. while continuing to administer Haldol to her. Neither party has indicated that such evidence exists.

In responding to HCFA's recitation of various indisputable facts of record, Petitioner notes only that an entry to this resident's file dated August 26, 1997, indicates that the physician's order was to maintain the current dosage of Haldol. Pet. Resp., at 5. Based solely on this entry, Petitioner takes the position that it was not out of compliance with 42 C.F.R. � 483.25(h)(2) because it lacked the discretion to deviate from the physician's order. Additionally, Petitioner relies on the portion of the State Operations Manual (SOM)(a manual used by surveyors for guidance), which indicates that "accidents" denote unintended or unexpected events, and should not be interpreted to mean adverse outcomes arising directly from treatment or care, such as the side effects of medications. Id., at 4. Petitioner's responses are inadequate for showing the existence of material factual disputes.

While it is true that Petitioner was not at liberty to discontinue or reduce the dosage of medications ordered by a physician, Petitioner does not allege (and the record before me does not suggest) that the physician directed the continuation of Haldol while prohibiting Petitioner from providing the adequate supervision or assistive device to prevent the likelihood of falls caused by the resident's use of Haldol. The physician was not under an obligation to comply with 42 C.F.R. � 483.25(h)(2). Therefore, as a matter of law, Petitioner is not relieved of its obligations under said regulation by the existence of a physician's order for continuing Isabella M.'s current level of Haldol. Petitioner has not identified the existence of any fact which may show that it was not possible for Petitioner to administer Haldol to Isabella M. as ordered by the physician, while also providing the adequate supervision or assistive device required by 42 C.F.R. � 483.25(h)(2).

Nor do I find that any issue of material fact has been created by Petitioner's interpretation of the surveyors' manual. Petitioner has misread the provision of the SOM it has quoted in an effort to support the theory that, if it were able to present evidence at a hearing that the physician had ordered the continued use of Haldol, then the reference contained in 42 C.F.R. � 483.25(h)(2) to "accidents" would be inapplicable as a matter of law to the risk of falling likely caused by Haldol. An evidentiary hearing is not necessary for this purpose. HCFA does not dispute that Haldol was ordered and continued for Isabella M. by her physician. The record currently before me is sufficient for concluding that Petitioner's interpretation of the manual and the legal theory based thereon are incorrect as a matter of law.

Contrary to what Petitioner suggests, the portion of the SOM quoted by Petitioner does not mean that Medicare certified nursing homes need not closely monitor and, to the extent possible, protect its residents against the known potential adverse effects of the medications administered to them. Such an interpretation would be contrary to the Medicare laws and the resultant regulatory enforcement scheme. If a nursing facility provides appropriate monitoring and takes the necessary precautions when its resident is using medications with known adverse side effects, only then may that facility claim that the consequences which resulted nevertheless from the use of those medications should be viewed as something other than "accidents" within the meaning of 42 C.F.R. � 483.25(h)(2). However, this is not the situation Petitioner wishes to show for Isabella M. by opposing HCFA's motion for summary judgment. There is no purpose to be served by scheduling a hearing in order to allow Petitioner to present uncontested evidence (the existence of the physician's order of August 26, 1997 to continue Haldol) to support an incorrect and inapposite legal theory.

Additionally, under the correct interpretation of 42 C.F.R. � 483.25(h)(2), the undisputed facts of record entitle HCFA to summary affirmance of its determination as to Isabella M. It is undisputed that Petitioner knew that Isabella M.'s continued use of Haldol under her physician's order would likely cause her to continue suffering adverse side effects which its own staff believes have contributed significantly to her frequent falls. It is undisputed also that Petitioner knew that she had fractured a hip during a prior fall. There is no basis for Petitioner to even intimate that this resident's physician had wanted her to sustain falls and be at risk for avoidable injuries while she is taking Haldol. Additionally, Petitioner has made no effort to oppose HCFA's renewed motion for summary affirmance by offering to show how or to what extent its staff had attempted to supervise or provide assistive devices to Isabella M., so that the risk of falling and injuries arising from any side effect of the Haldol usage ordered by her physician may be alleviated to the extent feasible.

In sum, with respect to Isabella M., Petitioner has not shown that any genuine issue of material fact exists for an evidentiary hearing.

b. Mae Ruth A. (Resident 4)

With use of its surveyors' observations on September 9, 1997 and Petitioner's records concerning Mae Ruth A., HCFA seeks summary affirmance of its determination that Petitioner was out of compliance with 42 C.F.R. � 483.25(h)(2) for this resident during the period under review. HCFA argues that even though Petitioner had provided her with a monitoring device to prevent falls, the device was not adequate because it was not functioning on the day of the survey, or it had not been applied properly on this resident. See HCFA Br., at 10-11; HCFA Rep., at 7-9.

There appears to be no dispute that when the survey was conducted during September 1997, Petitioner knew Mae Ruth A. was at risk for falls. Petitioner had discovered her on the floor near her wheelchair on two consecutive days in August 1997 (i.e., August 19, 1997 and August 20, 1997). Accordingly, on September 9, 1997, the surveyors observed that Mae Ruth A. was sitting in a wheelchair and wearing a monitoring device that was intended to sound an alarm if she attempted to stand up.

That monitoring device was attached to Mae Ruth A.'s clothing and her wheelchair in a manner that was different than the written instructions provided by Petitioner. For example, those instructions state that there should be no slack in the cord extending from the crossbars on the bottom of a wheelchair to the resident -- so that an alarm will sound if the resident moves forward or attempts to arise from that chair. The surveyor observed a frayed cord of about 36 inches in length extending from the right arm of Mae Ruth A.'s wheelchair to the back of her collar.

The surveyor asked Petitioner's Director of Nursing (DON) to demonstrate the workings of the device attached to Mae Ruth A. and her wheelchair. However, even though the instructions provided by Petitioner indicate that the alarm should sound as soon as the resident moves forward in her wheelchair or attempts to stand up, no alarm sounded even after Mae Ruth A. was brought to a standing position by Petitioner's DON. State surveyors did not verify Petitioner's correction of this problem until a subsequent re-survey, which was used in HCFA's determination that compliance had been attained by October 23, 1997.

Petitioner does not dispute the accuracy of the foregoing facts set forth by HCFA. It does not allege that, in addition to the chair alarm observed by the surveyors, other functioning monitoring or assistive devices were in place for Mae Ruth A. during the relevant time period to prevent her from accidentally falling out of her wheelchair and thereby injuring herself. Instead, Petitioner takes issue only with HCFA's argument that the chair alarm had placed Mae Ruth A. at risk for choking because a 36-inch long frayed cord for that device had been attached to that resident's collar. HCFA Br., at 10-11; Pet. Resp., at 5. Petitioner contends that the choking risk conclusion is unsupported by the facts. Pet. Resp., at 5.

Even by disregarding HCFA's conclusion that a choking hazard had been created by Petitioner's attachment of the chair alarm's long, frayed cord to the back of this resident's collar, I cannot rule in Petitioner's favor on the pending motion.

First, it is beyond doubt that a non-functioning monitoring device cannot be considered "adequate" within the meaning of 42 C.F.R. � 483.25(h)(2). Additionally, the intended purpose of the chair alarm was to prevent Mae Ruth A. from getting up unnoticed, and Petitioner does not suggest otherwise. There exists also a logical, undisputed nexus between Petitioner's wish to prevent this resident from getting up from her wheelchair unnoticed by staff, and her having fallen from her wheelchair in the past. There is also a logical and undisputed presumption arising from the facts of record that Petitioner had placed this resident in a wheelchair because she has a need for it due to her physical limitations. Nothing of record suggests that Petitioner placed alarms on all its residents' wheelchairs, or that Petitioner used chair alarms for residents who were at risk for only minimal harm. Under the circumstances, successful opposition of HCFA's renewed motion for summary affirmance would necessitate a showing that some facts exist which would permit a contrary conclusion for the elements of 42 C.F.R. � 483.25(h)(2).

Yet, in opposing summary affirmance, Petitioner has not described any evidence or theory which might show, for example, that falling out of a wheelchair unnoticed would not have placed Mae Ruth A. at risk for more than minimal physical harm. Nor does Petitioner's response brief even suggest the existence of any evidence which may show that, notwithstanding the non-functioning chair alarm discovered by the surveyors during September 1997, Petitioner had supervision procedures or functioning devices in place for Mae Ruth A. during the relevant time period to prevent her from falling out of her wheelchair and injuring herself accidentally. For these reasons, I grant HCFA's renewed motion as to Mae Ruth A.'s situation.

c. Martha M. (Resident 97)

The parties agree that Petitioner knew that Martha M. had a history of falls from a standing position. Hearing Request, 2; HCFA Rep., 9. I summarize below the other information drawn by HCFA from Petitioner's files for Martha M., and from the surveyors' observations relied upon by HCFA. See HCFA Br., at 9-10; HCFA Rep., at 7-9.

In essence, HCFA's theory is that Petitioner had failed to provide Martha M. with adequate supervision or an assistive device to prevent accidents, because the seat belt its staff applied to prevent this resident from falling out of her wheelchair was positioned incorrectly and was ineffective during the period under review. HCFA noted Petitioner's acknowledgments indicating that, when the surveyors made their on-site observations during the two consecutive surveys in August 1997 and September 1997, the seat belt on Martha M. had been placed in an inappropriate position.⁽¹⁴⁾ On August 30, 1997, Martha M. was able to loosen this belt and stand up from her wheelchair. Thereafter, she fell before Petitioner's staff could intervene.

It was not until after the September 12, 1997 revisit survey that Petitioner instituted training for its staff on the proper positioning of the seat belt. According to written instructions provided by Petitioner, the seat belt should be attached to both sides of a chair in the same manner, so that the belt would fit low and straight across the resident's lap.

In its brief responding to HCFA's renewed motion, Petitioner had the opportunity to dispute the foregoing facts and conclusions. Petitioner did not do so. Nor do the facts and observations cited by HCFA lead to a conclusion that is materially different than the one set forth by HCFA. For example, there is no reasonable basis for conjecturing that at no time during the relevant period was Martha M. at risk for more than minimal harm if she fell unattended from her wheelchair due to the improperly positioned and ineffective seat belt. Therefore, I accept as true HCFA's factually supported conclusion that Petitioner was out of compliance with its duty to Martha M. under 42 C.F.R. � 483.25(h)(2) during the period covered by the CMP of $50 per day.

2. Summary affirmance of the $50 per day CMP imposed for September 3, 1997 through and including October 22, 1997.

For 50 days, HCFA has imposed a CMP against Petitioner at the lowest daily rate allowed by regulation. 42 C.F.R. � 488.438(a). Having affirmed HCFA's determination that Petitioner remained out of compliance for those days, I am without the discretion to set aside or further reduce the minimum regulatory rate of $50 per day. 42 C.F.R. � 488.438(a) and (e)(1). Accordingly, I grant summary judgment to HCFA also on its imposition of $50 per day in CMP against Petitioner from September 3, 1997 until and including October 22, 1997.

For the reasons set forth above, I have resolved all outstanding issues in this case and granted HCFA's renewed motion for summary judgment.

1. Rulings Denying Petitioner's Motion To Strike And Denying HCFA's Motion For Summary Judgment; And Directives To Parties, dated August 11, 1998 (Ruling).

2. In its Notice of Issues For Which Summary Judgment Will Be Requested, dated March 2, 1998, HCFA stated that it had imposed a CMP of $8,600 upon Petitioner. The amount of the CMP consisted of $6,100 (at $3,050 per day) for two days of immediate jeopardy on September 1-2, 1997, and $2,500 (at $50 per day) for an additional 50 days of noncompliance encompassing the period September 3, 1997-October 22, 1997. See Notice, at 1; HCFA's Memorandum of Law In Support of HCFA's Motion For Summary Affirmance of CMP, dated March 23, 1998, at 2.

3. Along with the Renewed Motion of the Health Care Financing Administration for Summary Affirmance of Imposition of CMP, dated March 26, 1999, HCFA filed a supporting memorandum of even date (HCFA Br.). Petitioner filed a memorandum in opposition to HCFA's renewed motion on April 5, 1999 (Pet. Resp.), with documents designated as Exhibits (Ex.) A and B attached. HCFA then filed a reply memorandum on April 12, 1999 (HCFA Rep.), to which were appended pages which supplement Petitioner's Ex. B.

The briefs of the parties also referred me to other separately filed documents as support for their respective positions. I have reviewed those documents to the extent they were cited by either party.

4. As I noted in the Ruling, Ralph L. is the same individual who was referred in other documents of record as "Nick" or "Resident 175."

5. As I noted in the Ruling, at 6, the CMP ended on

October 22, 1997 as a consequence of an additional survey completed on November 10, 1997, as well as the outcome of an informal dispute resolution process. The evidentiary questions I had raised in my ruling concerning the choice of this end date are no longer relevant, given the position set forth by HCFA in support of its renewed motion for summary affirmance.

6. Petitioner submitted the subject document as part of its opposition to HCFA's initial motion for summary judgment. The document is a copy of a letter dated April 16, 1998, six days before Petitioner filed its brief opposing HCFA's initial motion. The letter is addressed to "To Whom It May Concern," from Dr. William Gorga, Ph.D., who states that he has been seeing this resident for psychological evaluation and behavioral management since October 8, 1997.

7. This is the same April 16, 1998 letter from Dr. Gorga, Ph.D., which was filed by Petitioner with its April 22, 1998 brief in opposition to HCFA's initial motion for summary judgment. See n.6, supra; Pet. Resp., Ex. A.

8. Pet. Resp., at 2.

9. Id.

10. Pet. Resp., at 2-4.

11. Id., at 2.

12. The attorney for Petitioner herein also represents other facilities which have been cited for their noncompliance with 42 C.F.R. � 483.25(h)(2) after their residents also have left those facilities unnoticed and unsupervised. Thus, Petitioner appended a portion of the transcript of the testimony in the Greenbriar Convalescent Center case, Docket No. C-97-431, where its counsel also represents Petitioner. I have not yet issued my decision in that case.

13. Pet. Readiness Statement, at 4.

14. The surveyors on those two consecutive surveys observed that a portion of the seat belt was up around the right side of Martha M.'s chest.