SUBJECT:

Evergreene Nursing Care Center,

Petitioner,

Centers for Medicare & Medicaid Services.

DECISION

I find that Petitioner, Evergreene Nursing Care Center, complied substantially with Medicare participation requirements as of May 26, 2005. Consequently, the Centers for Medicare & Medicaid Services (CMS) is not authorized to terminate Petitioner's participation in the Medicare program based on its determination that Petitioner was not complying with participation requirements on May 26, 2005.

I. Background

Petitioner is a skilled nursing facility that does business in the State of Virginia. It has participated in the Medicare program. Participation in that program by a skilled nursing facility is governed by sections 1819 and 1866 of the Social Security Act (Act) and by regulations at 42 C.F.R. Parts 483 and 488.

CMS notified Petitioner that Petitioner's participation in Medicare would be terminated effective June 27, 2005. CMS based its determination on findings of noncompliance with participation requirements that were made at compliance surveys of Petitioner that were completed on December 1, 2004 (December survey), January 21, 2005 (January survey), March 4, 2005 (March survey), and May 26, 2005 (May survey). ⁽¹⁾

Petitioner requested a hearing and the case was assigned to me for a hearing and a decision. Petitioner moved that the hearing be expedited. I granted Petitioner's request and held an in-person hearing in Washington, D.C., on July 14, 2005. At the hearing CMS offered, and I received into evidence, exhibits consisting of CMS Ex. 1 - CMS Ex. 29. Petitioner offered, and I received into evidence, exhibits consisting of P. Ex. 1 - P. Ex. 33.

Petitioner submitted an additional exhibit, P. Ex. 34, with its post-hearing brief. The exhibit consists of the affidavit of Shelly Palmisano, Petitioner's Assistant Director of Nursing. Attached to the affidavit are documents from a manufacturer pertaining to a "Personal Sentry," described as a "fall prevention monitoring system," and a "Bed Sentry." P. Ex. 34, at 4 - 16. CMS objects to my receiving P. Ex. 34 into evidence. I overrule the objection and receive the exhibit.

Petitioner submitted the exhibit in response to a series of questions that I asked both parties at the inception of the hearing:

[W]hat are the differences between a bed pad alarm and a PSA [the term "PSA" appears in Petitioner's records]. Unclear to me what a PSA does or what a bed pad alarm does. How do they work? How do they operate? Are there some inherent advantages of one over the other? Is there some reason why a doctor would say bed pad alarm or bed alarm but not PSA or was the - are the alarms essentially interchangeable?

Transcript (Tr.) at 2. My questions were prompted by CMS's allegations that Petitioner's staff had failed to carry out instructions that it supply certain residents with bed alarms. Petitioner contended, and the record seemed to evidence, that other types of alarms (PSAs) were supplied in lieu of those that were ordered. I wanted to know whether the different types of alarms were equivalent functionally.

The information contained in P. Ex. 34 is helpful in answering those questions. Petitioner did nothing improper by submitting the exhibit after the hearing inasmuch as I had, in effect, requested it. I can discern no prejudice to CMS from receiving P. Ex. 34 into the record. I gave CMS the opportunity to provide supplemental evidence responding to the exhibit and addressing the questions that I had asked about bed alarms and PSAs. Although CMS continues to object to the exhibit it does not offer any evidence to rebut it. ⁽²⁾

Central to CMS's objection to P. Ex. 34 is that it contains statements from Ms. Palmisano which differ from that which the witness offered previously in written direct testimony. CMS asserts that, at the least, it should be afforded the opportunity to cross-examine Ms. Palmisano on those statements that, in its opinion, vary from those which she offered previously. I find such additional cross-examination to be unnecessary. As I explained to the parties during the August 11 conference call, I am receiving the exhibit for only one purpose. That is to explain the differences, if any, between the alarm systems that physicians ordered for certain residents and the systems that Petitioner's staff utilized for those residents. The testimony that Ms. Palmisano offers in P. Ex. 34 concerning that issue, as corroborated by attachments to the exhibit, does not "differ" from her previous testimony. Rather, it addresses only questions that I asked on the record at the hearing. CMS has not indicated how cross-examination of Ms. Palmisano as to that portion of her testimony would undercut or impeach her testimony as to that limited issue in any respect.

I do not rely in this decision on any testimony by Ms. Palmisano in P. Ex. 34 other than that which addresses the difference, if any, between alarm systems. I note specifically, that I do not rely on P. Ex. 34 as support for any conclusions that I make as to whether and when residents were wearing alarms. I draw my conclusions as to that issue from evidence found elsewhere in the record of this case.

II. Issue, findings of fact and conclusions of law

A. Issue

The issue in this case is whether Petitioner failed to comply substantially with one or more Medicare participation requirements as of May 26, 2005.

B. Findings of fact and conclusions of law

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

1. It is not necessary that I decide whether Petitioner complied with participation requirements prior to May 26, 2005 in order to decide whether CMS had the authority to terminate Petitioner's participation in Medicare on that date.

CMS argues that noncompliance findings made at the December, January, March, and May surveys establish that Petitioner manifested at least six consecutive months of noncompliance with Medicare participation requirements. According to CMS, its decision to terminate Petitioner was made mandatory by virtue of this alleged six month period of noncompliance. See 42 C.F.R. § 488.412(a); CMS's pre-hearing brief at 4 - 5.

Obviously, it would be necessary to consider the findings of noncompliance made at the December, January, and March surveys, along with those made at the May survey, if the question that I had to resolve in this case was whether Petitioner was noncompliant for at least six consecutive months. However, it is not necessary that I address this issue. The issue that I must decide is whether Petitioner was not complying substantially with Medicare participation requirements as of the completion of the May survey.

CMS has discretionary authority to terminate a facility's participation in Medicare at any time that a facility is out of compliance with one or more participation requirements. Act, section 1866(b)(2). The presence of even one deficiency will suffice to justify termination of participation. Id. Consequently, a facility's compliance history - and the issue of whether termination of participation is mandatory as opposed to being discretionary - becomes moot if CMS determines to terminate that facility's participation in Medicare as of a particular date. All that is relevant is the facility's compliance status as of the date of termination.

CMS determined to terminate Petitioner's participation after Petitioner allegedly had not attained compliance with participation requirements as of May 26, 2005. If Petitioner was in fact noncompliant on that date, then CMS was authorized to terminate Petitioner's participation then pursuant to section 1866(b)(2) of the Act irrespective of what Petitioner's compliance status may have been over the preceding six months. By contrast, if Petitioner was, in fact, complying with participation requirements as of May 26, CMS would not have the authority to terminate Petitioner's participation even if Petitioner was noncompliant previously. That is because there would be no ongoing noncompliance to justify termination of participation. ⁽³⁾

2. The preponderance of the evidence establishes that Petitioner complied substantially with Medicare participation requirements as of May 26, 2005.

The surveyors who conducted the May survey found Petitioner to be noncompliant with six distinct regulations. CMS Ex. 9. Specifically, the surveyors found Petitioner not to be complying with:

• 42 C.F.R. § 483.13(a). CMS Ex. 9, at 1 - 4;

• 42 C.F.R. § 483.20(k)(2). CMS Ex. 9, at 4 - 8;

• 42 C.F.R. § 483.20(k)(3)(i). CMS Ex. 9, at 8 - 11;

• 42 C.F.R. § 483.25. CMS Ex. 9, at 11 - 15;

• 42 C.F.R. § 483.25(a)(2). CMS Ex. 9, at 16 - 18; and,

• 42 C.F.R. § 483.25(h)(2). CMS Ex. 9, at 18 - 23.

CMS no longer contends that Petitioner failed to comply substantially with the requirements of 42 C.F.R. § 483.20(k)(3)(i). Tr. at 2 - 3; see CMS Ex. 9, at 8 - 11. The question before me, therefore, is whether Petitioner failed to comply substantially with any of the five other regulations that the surveyors cited in their May survey report. Failure by Petitioner to comply with any of these regulations would give CMS authority to terminate Petitioner's participation in Medicare. CMS would not be authorized to terminate Petitioner's participation if Petitioner complied with all five of them.

a. CMS did not prove a prima facie case that Petitioner failed to comply substantially with the requirements of 42 C.F.R. § 483.13(a).

The regulation at issue provides that a resident of a facility :

has the right to be free from any physical or chemical restraints imposed for purposes of discipline or convenience, and not required to treat the resident's medical symptoms.

42 C.F.R. § 483.13(a). CMS's allegations that Petitioner failed to comply with this regulation all relate to the care that Petitioner provided to a resident who is identified in the May survey report as Resident # 302. The undisputed evidence shows Resident # 302 to be an individual who is totally dependent on nursing staff for all activities of her life. P. Ex. 30, at 5. She suffers from medical problems that include dementia, a history of fracture of the right hip, severe malnutrition, leukemia, and a subdural hematoma. CMS Ex. 9, at 3 - 4. In April 2005 Petitioner's staff observed that the resident had both long- and short-term memory problems and moderately impaired cognition. It assessed the resident as being totally dependent on the staff for transfer, dressing, bathing, and hygiene. Id. She needed extensive assistance from Petitioner's staff in order to eat and was unable to ambulate. Id.

In March 2005 the resident's physician ordered that she wear a lap buddy. P. Ex. 13-A, at 1. A lap buddy is a barrier that fits to the arms of a wheelchair across the occupant's lap. Tr. at 94 - 95. It is secured in part by velcro straps. Id. It is designed to restrain an individual from standing while it is in place. However, a lap buddy provides sufficient freedom of movement so that an individual who is restrained by it may shift position in the wheelchair. Id.

The physician ordered that a lap buddy be supplied for Resident # 302 based on her medical condition and on her inability to understand or recall safety instructions. P. Ex. 13-A, at 1; P. Ex. 30, at 5, 6. The physician specified that the lap buddy should be released every two hours. Id. The resident's physician did not order mealtime release of the lap buddy. P. Ex. 30, at 6. But, an undated nursing care plan remarked that the lap buddy would be released at two-hour intervals and at mealtimes. P. Ex. 13-A, at 2.

CMS makes two assertions concerning Petitioner's alleged failure to comply with the requirements of 42 C.F.R. § 483.13(a). First, and principally, it asserts that, contrary to the resident's physician's instructions, Resident # 302's lap buddy was not released at two-hour intervals. ⁽⁴⁾ Second, it contends that, on May 25, 2005, the resident was observed with the lap buddy in place during a meal, contrary to the resident's nursing care plan.

CMS did not offer eyewitness testimony that supports its contention that Petitioner's staff failed to release the resident's lap buddy at two-hour intervals. The survey report recites a statement by another resident, identified as "the companion" of Resident # 302, that the only time the resident's lap buddy was removed was "when she went to bed and to the bathroom." CMS Ex. 9, at 2. This statement has no probative value. Aside from the fact that the statement is hearsay, there is no evidence that would suggest that "the companion" had observed the resident continuously and on a day-by-day basis so as to make the statement credible. Moreover, and as CMS concedes, this resident has dementia. CMS's post-hearing brief at 3. The fact that the resident "was interviewable and could answer questions regarding Resident # 302" says nothing about the resident's memory or cognitive ability. See Id.

CMS also seems to suggest that a surveyor, JoAnn Bonesteel, R.N., observed that the resident's lap buddy was not being released at two-hour intervals. CMS's pre-hearing brief at 7. Ms. Bonesteel's testimony does not support this apparent assertion. Ms. Bonesteel does not contend in her written direct testimony that she observed Resident # 302 on a continuous basis and documented failures by Petitioner's staff to release the resident's lap buddy at two-hour intervals. See CMS Ex. 29, at 7 - 14.

At bottom, CMS relies on Petitioner's resident records to support its contention that Petitioner's staff did not release Resident # 302's lap buddy pursuant to the schedule directed by the resident's physician. In its pre-hearing brief, CMS asserts that proof that the resident's lap buddy was not being released as per the physician's orders may be found in a record generated by Petitioner's staff consisting of the record of routine treatments provided for Resident # 302 during the months of April and May 2005. CMS Ex. 21, at 91, 96; P. Ex. 13-C, at 1 - 2. This is a document that records scheduled and routine treatments that were provided to the resident during April and May 2005, including release of the lap buddy. The first vertical column of each page of the document lists routine treatments that the resident received. Among these is an entry which reads: "lap buddy due to diagnosis & inability to recall safety instructions. Release every 2 hours." Id. Next to the entry are horizontal columns divided into blocks for each day of the month. Id. These blocks are subdivided vertically so that three nursing shifts (10 p.m. - 6 a.m., 6 a.m. - 2 p.m., and 2 p.m. - 10 p.m.) are shown. Id. The blocks contain initials which I infer are those of individual members of Petitioner's nursing staff, evidently made to signify that a routine service was completed as prescribed during a particular shift on a given day.

CMS relies on the fact that there are blocks that are not initialed in the lines that denote release of the lap buddy. During the months of April and May, there are a total of eight blocks that are not initialed. CMS Ex. 21, at 91, 96; P. Ex. 13-C, at 1 - 2. CMS asks that I infer that the resident's lap buddy was not released during specific nursing shifts from the failure by staff to initial blocks documenting care given during those shifts.

I do not find the requested inference to be reasonable. The record of routine treatments is unpersuasive prima facie evidence that Petitioner failed to obey the physician's orders for Resident # 302. The report is, at best, highly ambiguous evidence of what the staff did or did not do for the resident at any given time. It does not necessarily follow logically that the staff failed to follow a physician's order from an employee's occasional omission to initial a block showing that the order was carried out. The omission to initial the block may be simply that - a failure by the staff to complete its paperwork - and may not signify that the staff failed to provide care.

The ambiguous meaning of the document is made evident by the way in which staff either initialed or failed to initial the blocks denoting that services were provided to the resident. In those few instances where a staff member omitted to initial a block showing that the lap buddy was released that same staff member also omitted to initial all other blocks pertaining to other services which were ordered provided to the resident. CMS Ex. 21, at 91, 96; P. Ex. 13-C, at 1 - 2. For example, on May 23, 2005, the staff member who worked on Petitioner's 2 - 10 p.m. shift omitted to initial a block signifying that the resident's lap buddy had been released at two-hour intervals. But, that same staff member also omitted to initial blocks to show that: ointment had been applied to the resident's perineal area; the resident had been checked at 30-minute intervals while in bed; a bed safety mat had been in place; and, the resident had been turned while in bed. CMS Ex. 21, at 96; P. Ex. 13-C, at 2.

These omissions arguably support a finding that no routine services were provided to the resident during the 2 - 10 p.m. shift on May 23 or on other shifts when no blocks were initialed. But, an inference that is just as reasonable is that the person who worked on that shift provided all routine services and simply omitted to complete the paperwork for the shift. This ambiguity makes the report less than compelling proof. Standing by itself, it simply does not make out a prima facie case that Petitioner's staff omitted to release Resident # 302's lap buddy at prescribed intervals. ⁽⁵⁾

However, assuming for argument's sake that the report does accurately document when the lap buddy was released, the omissions relied on by CMS are very few when compared with the overall record of care that was provided to Resident # 302. Assuming that the report of routine treatments accurately documents all of the care given to Resident # 302, it shows that the resident received what was prescribed to her more than 95 percent of the time. As I discuss below, CMS has not made a prima facie showing that there was a potential for even minimal harm to the resident from the few instances in which the lap buddy was not released per the physician's orders, assuming that the record of routine care is accurate.

In its post-hearing brief CMS makes a new argument. It now contends that proof that the Resident's lap buddy was not being released as ordered may be found in resident records that are headed with the phrase "treatment assessment." CMS's post-hearing brief at 2; see CMS Ex. 21, at 18 - 40. According to CMS, on some shifts, on a number of dates, the treatment assessment for that date lacks a check mark or marks showing that the lap buddy was released per the physician's order. CMS contends that it is logical to infer that the lap buddy was not released on a given shift if a check mark is absent for that shift.

I find the "treatment assessments" to be unpersuasive prima facie proof that Petitioner's staff failed to follow the physician's order. CMS has laid no foundation to explain what these forms mean. There is nothing in the record to explain the purpose for generating them or their significance. Some of the treatment assessments contain the handwritten phrase "lap buddy" in the lower right hand corner. See, e.g., CMS Ex. 21, at 28. Next to some of those phrases there are check marks. In other instances, the phrase is absent altogether from the treatment assessment. Absent some foundation, I have no idea why the phrase "lap buddy" was written in on some, but not all of the forms, and I have no idea why there are check marks in some, but not all of the forms, next to the phrase "lap buddy." I do not know whether the check marks that are present in some of the forms signify that a lap buddy was in use during a shift or whether it was released periodically during that shift. I do not know whether the staff was required to document use of the lap buddy on the treatment assessment or whether staff members had the option to use the form for that purpose. I note that, frequently, there is no check mark made for afternoon or night shifts. Could that be because the resident was in bed and a lap buddy was not in use? The form gives me no clue as to whether that would be a logical inference or not.

The evidence relied on by CMS does not suggest that Petitioner's staff was restraining Resident # 302 for purposes of discipline or convenience. In this instance a few omissions to strictly follow the physician's order - if, in fact, such omissions occurred - are simply not enough for me to infer that the staff was restraining the resident for other than a medically required purpose. Indeed, the weight of the evidence, including the resident's treatment records and the testimony of the resident's physician, strongly supports the conclusions that the physician determined that it was medically necessary to restrain the resident and that the staff merely executed the physician's order. P. Ex. 30, at 7.

CMS contends that the potential for more than minimal harm existed even if there were only a few instances where the staff failed to release the resident's lap buddy pursuant to the physician's order. CMS's post-hearing brief at 4 - 5. It contends that: "physical restraints can be psychologically damaging even to a person with dementia." Id. at 5. It has offered no prima facie evidence to support this contention. CMS's assertion might have been persuasive had it offered, for example, expert testimony to establish the potential for harm resulting from occasional failure to release a lap buddy for a resident suffering the impairments that Resident # 302 experiences. But, CMS offered nothing.

CMS cites case law to support its contention that even a single instance of noncompliance may be a basis for finding noncompliance with a participation requirement. CMS's post-hearing brief at 5. I have no quarrel with this principle. But, that doesn't mean that every error or omission by staff at a facility must be construed as a failure to comply substantially with a participation requirement. Proof of an error or omission is only the first step in establishing noncompliance. CMS has the additional burden - which it did not meet here - of putting in prima facie proof that the error or omission is potentially harmful. Moreover, and as I discuss in detail, above, CMS did not offer persuasive prima facie proof that the staff in fact erred in providing care to Resident # 302.

CMS has contended throughout that Resident # 302 was unable to release the lap buddy volitionally. CMS's post-hearing brief at 3. It is unclear to me what significance this contention - which is undoubtedly correct - has to this case. The whole purpose of the lap buddy was to restrain the resident. That purpose would be defeated if the resident could release it at her will. Consequently, the fact that the resident could not do so is of no import.

Finally, the fact that on one occasion the resident was observed to be wearing a lap buddy during a meal is not persuasive evidence that a potential for more than minimal harm existed by virtue of the failure to release the lap buddy. The decision to remove the lap buddy during meal times was a staff decision. The physician had not ordered that the lap buddy be removed during meals and it would have been entirely consistent with the physician's orders if the staff had simply fed the resident while she was wearing the restraint. Thus, leaving the resident restrained during meals would be consistent with the medical purpose of restraining her.

b. CMS did not prove a prima facie case that Petitioner failed to comply substantially with the requirements of 42 C.F.R. § 483.20(k)(2).

The regulation at issue provides that a comprehensive care plan for each resident must periodically be reviewed and revised by a team of qualified persons after each comprehensive assessment is made of the resident. 42 C.F.R. § 483.20(k)(2)(iii). It provides additionally that a care plan must be generated within seven days after completion of a comprehensive assessment. 42 C.F.R. § 483.20(k)(2)(i). And, it requires that a care plan be generated by an interdisciplinary team. 42 C.F.R. § 483.20(k)(2)(ii).

CMS alleges that Petitioner failed in three instances to comply with these requirements. According to CMS, Petitioner failed to revise the plans of care for:

• A resident who is identified in the May survey report as Resident # 301, after the resident was moved from a bed with raised side rails to a concave floor mattress;

• Resident # 302, in order to address the resident's inability to self-release her lap buddy; and

• A resident who is identified in the May survey report as Resident # 308, to address the provision of a bed alarm to the resident.

CMS Ex. 9, at 4 - 8.

I find that CMS failed to prove a prima facie case that Petitioner failed to comply with any of the subsections of 42 C.F.R. § 483.20(k)(2). The allegations made by CMS, even if they are true, do not describe noncompliance with the regulation.

The regulation prescribes how and when a resident's care plan must be modified after completion of a written comprehensive assessment or reassessment of a resident. It is a subsection of a broader regulation, 42 C.F.R. § 483.20. The purpose of the broader regulation is to require a facility to conduct initially and periodically a comprehensive, accurate, standardized, and reproducible assessment of each resident's functional capacity. A comprehensive assessment is defined at 42 C.F.R. § 483.20(b)(1) to include 18 specific items. Such an assessment is obligatory: within 14 calendar days after a resident's admission to a facility; within 14 days after a facility determines, or should have determined, that there has been a significant change in the resident's physical or mental condition; and, not less than once every 12 months. 42 C.F.R. § 483.20(b)(2)(i) - (iii). Additionally, a facility must conduct a quarterly review assessment of each resident at three-month intervals. 42 C.F.R. § 483.20(c).

Subsection (k)(2) is a provision which addresses a facility's obligations after it has completed the comprehensive assessment. It links the broader regulation's requirement that comprehensive assessments be performed to a requirement that the findings of comprehensive assessments be reflected in a resident's care plan. The subsection plainly states that a resident's plan of care must be reviewed and revised after each comprehensive assessment of a resident's condition.

What this subsection does not address is the question of whether or when a facility ought to have made a comprehensive assessment. Consequently, 42 C.F.R. § 483.20(k)(2) may not be read as directing when a comprehensive assessment or reassessment of a resident's condition must occur. The circumstances under which a comprehensive assessment or reassessment must be made are addressed by subparts (b) and (c) of the regulation.

It is also made clear by 42 C.F.R. § 483.20(k)(2) that not every change in care that is provided to a resident automatically triggers a requirement that the facility revise the resident's care plan to document that change. The regulation imposes only the duty on a facility to revise a plan of care in the circumstance where it has made a new comprehensive assessment of the resident. And, the duty to make a new comprehensive assessment only exists under the circumstances that are defined at 42 C.F.R. §§ 438.20(b) and (c). Under the regulation, a change in care that is not the consequence of a new admission, a periodic reassessment of the resident, or a significant change in the resident's medical condition, need not be documented in a revised care plan. ⁽⁶⁾

It is not possible to address a facility's obligations under 42 C.F.R. § 483.20(k)(2) without first answering one of two threshold questions. First, did the facility actually perform a new or revised comprehensive assessment of one or more residents? If it did, then, plainly, it had an obligation to revise its residents' care plans to reflect the outcomes of the comprehensive assessments. Second, did the facility have a duty - which it failed to discharge - to perform a new or revised comprehensive assessment? In the latter circumstance, if a facility failed to meet its obligation to perform a new or revised comprehensive assessment then, by extension, it also violated its obligation to write a care plan to reflect the assessment that it ought to have performed.

The evidence offered by CMS fails to answer either of these questions affirmatively. Consequently, there is no basis for me to find that Petitioner failed to comply with the requirements of 42 C.F.R. § 483.20(k)(2). First, CMS offered no evidence whatsoever to show that Petitioner had made new or revised comprehensive assessments of residents that it failed to implement. Indeed, CMS did not even allege that Petitioner had made assessments that it did not implement. Second, CMS offered no prima facie proof to show that Petitioner was under an obligation to make new or revised comprehensive assessments of the three residents whose care is at issue and to implement the findings of those assessments with new or revised care plans for the residents.

In answering the first threshold question I find that neither the surveyors nor CMS alleged that Petitioner had made new or revised comprehensive assessments of the conditions of Residents #s 301, 302, and 308, as described at 42 C.F.R. § 483.20(b)(2)(i) - (iii) and (c), thereby necessitating modifications in these residents' plans of care. Such an allegation is neither explicit nor implicit in the May survey report or in CMS's arguments, either in its pre-hearing or even in its post-hearing brief.

As to the second threshold question, as I discuss above, the three circumstances that necessitate comprehensive assessments and care plan revisions consist of: new admission of a resident to a facility; periodic review of a resident's condition; and a significant change in a resident's condition. There is nothing in CMS's allegations to suggest that any of the three residents whose care was at issue were new admissions. Nor does CMS allege that Petitioner failed to perform a requisite periodic comprehensive assessment of a resident. That leaves open the possibility that there were significant changes in the medical conditions of Residents #s 301, 302, and 308 that necessitated revised comprehensive assessments of these residents and revisions of their plans of care. Only in that event could Petitioner be found to have failed to comply with the requirements of 42 C.F.R. § 483.20(k)(2).

The allegations that the surveyors and CMS made concerning each of the three residents contain common features. In the case of each resident Petitioner's staff initiated, or was directed to initiate, a change of the resident's treatment regimen. In the case of Resident # 301, the resident - who suffered from severe cerebral palsy - was moved from a bed with side rails to a concave mattress on the floor. In the case of Resident # 302, whose care I have discussed above, at Finding 2.a., the resident was restrained with a lap buddy. In the case of Resident # 308, the resident's physician prescribed that an alarm be placed in the resident's bed. CMS Ex. 9, at 4 - 8. The surveyors asserted that these changes in the residents' treatment regimens should have been documented by modifications to the residents' plans of care. Id. However, the surveyors do not allege that there were significant changes in the residents' conditions that necessitated new assessments or care plan modifications.

In its pre-hearing brief CMS essentially repeats without amplification the surveyors' allegations. CMS's pre-hearing brief at 8 - 13. CMS does not offer any explanation as to how 42 C.F.R. § 483.20(k)(2) could possibly apply to the facts given that neither it nor the surveyors alleged that the changes in the residents' care reflected significant changes in the residents' conditions. The gravamen of Petitioner's noncompliance, according to CMS, is that the residents care plans failed to reflect the changes that allegedly had been instituted in their treatment regimes. But, nowhere in its pre-hearing arguments does CMS contend that such changes in care reflected underlying significant changes in residents' medical conditions.

CMS makes similar arguments in its post-hearing brief. For example, in its post-hearing brief it argues that "the heart" of Petitioner's allegedly deficient care of Resident # 308 is the failure of the resident's care plan to mention that a bed alarm had been ordered for the resident. CMS's post-hearing brief at 7 - 8. Assuming the truth of that contention it begs the question of whether Petitioner failed to comply with the requirements of 42 C.F.R. § 483.20(k)(2), because it does not address the question of whether ordering the bed alarm reflected some significant change in the resident's underlying medical condition.

The facts identified by the surveyors in the May survey report do not, on their face, suggest that significant changes occurred in the conditions of the three residents whose care is discussed. I am not persuaded to assume that there were significant changes in these residents' condition absent some prima facie proof that such changes occurred. It is not sufficient to assert that there must have been significant changes in the residents' conditions based only on the fact that there were changes in these residents' care. A change in care may reflect a change in a resident's condition. But, it may also reflect other factors or events. It is CMS's burden to offer prima facie evidence explaining why a change in care should be interpreted to evidence a significant change in a resident's condition. CMS failed to offer evidence or analysis that would support such an inference here.

For example, the only evidence cited by the surveyors concerning Resident # 301 is a physician's order that the resident be moved to a concave floor mattress and that side rails be discontinued. CMS Ex. 9, at 5. There is no discussion in the survey report as to what motivated this change in care. There is no suggestion in the report that the resident's condition had worsened or improved or that the resident had developed new problems that necessitated the change in treatment. Consequently, one may not infer that the switch of sleeping arrangements from a bed with side rails to a concave floor mattress necessarily reflected some underlying change in the resident's condition that was significant. ⁽⁷⁾

In the case of Resident # 302, the surveyors assert only that the resident was unable to release a lap buddy upon request even though a goal stated in the resident's plan of care was that the resident be able to do so. Id. at 6 - 7. There is no explanation offered as to why this observation would suggest an underlying change in the resident's condition.

In the case of Resident # 308, the surveyors' findings concerning that resident note that the resident had apparently received a bed alarm but that the resident's care plan had not been modified to reflect that change in the resident's care. Id. at 7 - 8. The surveyors identify nothing to show that this change in care reflected a significant change in the resident's condition.

Finally, I conclude that CMS offered no prima facie evidence that there was a potential for harm resulting from Petitioner's failure to amend these residents' care plans, assuming for argument's sake that Petitioner was obligated to amend the plans. With respect to Resident # 301, the undisputed fact is that the resident was moved from a bed with side rails to a floor mattress pursuant to a physician's order. Petitioner's staff merely executed that order. CMS has not explained how facility staff may be found liable for causing even potential harm to a resident based on the staff's faithful execution of a physician's order but failure to document its action in the resident's care plan. In the case of Resident # 302, I have discussed in detail above, at Finding 2.a., why I do not believe that CMS established a potential for harm in the staff's care of that resident. As far as Resident # 308 is concerned, CMS has offered no prima facie evidence to explain why failing to amend the resident's care plan to reflect that a bed alarm was ordered for the resident would have put the resident at risk in light of the fact that the alarm order is documented elsewhere in the resident's treatment record.

c. The preponderance of the evidence does not support a finding that Petitioner failed to comply with the requirements of 42 C.F.R. § 483.25.

The general requirement of 42 C.F.R. § 483.25 is that each resident of a facility must receive, and the facility must provide, the necessary care and services for the resident to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with that resident's comprehensive assessment and plan of care.

The allegations that Petitioner failed to comply with the requirements of the regulation relate entirely to the care that Petitioner gave to Resident # 301. CMS Ex. 9, at 12 - 15. CMS makes two general allegations concerning Petitioner's alleged deficiency. First, it contends that Petitioner failed to comply with the resident's physician's order that the resident be weighed weekly. Second, CMS asserts that Petitioner's staff failed to monitor the resident's intake and output of fluids. These failures, according to CMS, potentially harmed the resident's well-being.

The record does not support these allegations. I find that Petitioner did weigh the resident consistent with a physician's order. I also conclude that Petitioner's staff appropriately monitored the resident.

On November 12, 2004, the physician ordered Petitioner's staff to obtain the resident's weight every week. CMS Ex. 20, at 7. The order does not explain why it was necessary to obtain weekly weights of this resident. See Id. However, it is reasonable to infer that the order related to the resident's physical condition. The resident suffered from severe cerebral palsy and associated mental retardation. Maintaining the resident's weight was a difficult problem for Petitioner and its staff to contend with. During the resident's stay at Petitioner's facility her weight ranged from a high of 83 pounds to a low of 64.8 pounds. Id. at 29 - 30. Obviously, the physician wanted the resident's weight monitored as an aspect of the physician's concern that the resident's nutritional status be followed closely by Petitioner's staff.

CMS argues that the resident was at risk for severe injury or death from malnutrition yet Petitioner's staff failed to comply with the physician's order to weigh her. The record of the resident's weights made by Petitioner's staff shows that the staff weighed, or attempted to weigh, the resident regularly at weekly intervals going back to November, 2004. It weighed the resident on March 30, April 6, April 13, April 22, and April 29, 2005. After April 29, the staff did not weigh the resident again until May 11, 2005. CMS Ex. 20, at 30. CMS asserts that this lapse in time between the April 29 and May 11, 2005 weights is proof that Petitioner's staff did not follow the physician's order by obtaining the resident's weight every week. According to CMS, the potential harm to Resident # 301 of this alleged compliance failure is made evident by the fact that the resident's weight had declined to 67.4 pounds on April 29. Id.

However, this evidence omits important facts that establish that Petitioner's staff complied with the physician's order to obtain the resident's weight on a weekly basis. Resident # 301 was hospitalized from May 1 - 3, 2005 in order to replace a PEG tube (a form of feeding tube). P. Ex. 12-L, at 1 - 4. Petitioner's staff was unable to weigh the resident during this three-day period. ⁽⁸⁾ On May 4, 2005, after the resident had returned form the hospital, the resident's physician reissued her order that the resident be weighed weekly. CMS Ex. 20, at 7. Petitioner's staff complied with the renewed order by weighing the resident on May 11, 2005, a week after it was issued. CMS Ex. 20, at 30.

The physician's May 4, 2005 order reiterates her long-standing order that the resident be weighed weekly. CMS contends that the staff should have understood the physician's intent as being that the resident be weighed at least once during every week that the resident was at Petitioner's facility. Under this analysis Petitioner was remiss in not weighing Resident # 301 during the week that ended with Saturday, May 7, 2005, notwithstanding the resident's three-day stay at the hospital during this week and notwithstanding also the physician's May 4, 2005 order.

I conclude that Petitioner's staff was not obligated to weigh Resident # 301 at a date that was earlier than May 11. The staff complied, literally, with the physician's order. CMS has offered nothing that convinces me that the staff should have disregarded the order. Furthermore, the evidence does not show a potential for more than minimal harm to the resident assuming that the staff was, in fact, remiss in failing to weigh the resident before May 11.

Petitioner's physician, Dr. Mary Preston, testified that the resident was nutritionally stable. P. Ex. 30, at 3 - 4. She concluded that weighing the resident pursuant to a rigid schedule was not necessary. Tr. at 83 - 84. The single instance of alleged failure to weigh the resident at precisely one-week intervals - when viewed in the context of the staff's scrupulous compliance with the physician's order over a period of months - consequently posed no potential for harm. I find this testimony to be persuasive. Dr. Preston's testimony is corroborated by the record of Resident # 301's May 1 - May 3, 2005 hospital stay. The discharge report from that stay notes that the resident's laboratory values were largely unremarkable and unchanged from the resident's baseline, supporting Dr. Preston's conclusion that the resident was nutritionally stable. P. Ex. 12-L, at 2.

CMS argues that Petitioner's staff was put on notice that it had to weigh Resident # 301 prior to May 11, 2005 by weight records showing a significant decline in the resident's weight between April 22 and April 29, 2005. On April 22 the resident's weight was recorded at 72.8 pounds and on April 29 it was recorded at 67.5 pounds. CMS Ex. 20, at 30. According to CMS this sudden, sharp decline in the resident's weight should have alerted Petitioner's staff to a potentially severe nutritional problem and, consequently, should have put the staff on notice to be ultra-diligent in recording the resident's weight the following week.

I do not find this argument to be persuasive. As I discuss above, the staff literally followed the physician's order in obtaining the resident's weight. CMS has not offered any proof to show that Petitioner or its staff was obligated to go beyond the letter of the physician's order. Furthermore, I conclude that, CMS's argument notwithstanding, the resident's record did not contain facts establishing that it was critical to obtain the resident's weight the week prior to the week of May 11, 2005. To the contrary, the record supports Dr. Preston's conclusion that it was not necessary to follow a rigidly adhered to schedule in obtaining the resident's weight.

The individual weights that were recorded for Resident # 301 were not particularly accurate. The spastic movements caused by the resident's cerebral palsy made it extremely difficult to weigh her accurately. Tr. at 81; P. Ex. 30, at 4. For that reason, a specific weekly weight was not especially important in evaluating the resident's overall health, although the long-term trend in the resident's weight was important. Consequently, there was nothing in the record that made it urgent that staff obtain the resident's weight at precisely one-week intervals.

Sharp declines or increases in the resident's weight from week to week very likely were a consequence of the problems associated with weighing her. That conclusion is strongly supported by the record of the resident's weight. On a few occasions staff recorded that it had been "unable" to obtain the resident's weight. CMS Ex. 20, at 29. The resident's weight was recorded as fluctuating sharply from week to week, a pattern of weights that is consistent with the resident being difficult to weigh. For example, on February 9, 2005, the resident's weight was recorded at 77.2 pounds. On February 16, her weight was recorded to have dropped to 71.7 pounds, a more than five-pound loss. But, on February 23, 2005, the resident's weight was recorded at 77.2 pounds. Id. As another example, the resident's weight was recorded at: 73.5 pounds on March 30, 2005; 64.8 pounds on April 6, 2005; and 76.6 pounds on April 13, 2005. Id. at 30. It is implausible that this resident could have lost nearly nine pounds in one week and then gained back almost 12 pounds the following week. Obviously, other factors account for this weight fluctuation, factors which, in my judgment, diminish the significance of weekly weights.

The approximately five-pound loss that the resident demonstrated between April 22 and April 27, 2005 was, therefore, not remarkable given the resident's history of being extremely difficult to weigh. I conclude that there was nothing about the resident's weights that would have put Petitioner and its staff on notice that it need do more than simply follow the order of the resident's physician.

Finally, CMS relies on the long-term decrease in the resident's weight as support for its contention that it was imperative for Petitioner's staff to weigh Resident # 301 every week. I do not find this argument to be persuasive. The decline in the resident's weight over time may arguably have been a reason for Petitioner's staff to be diligent in addressing the resident's nutritional status. But, CMS has not established any failure of diligence on the staff's part. ⁽⁹⁾

With regard to CMS's allegation that Petitioner's staff failed to monitor the resident's intake and output of fluids, CMS asserts that "there is not a scintilla of evidence" that shows that Petitioner's staff monitored Resident # 301 for dehydration or for possible poor intake of fluids as is allegedly required by the resident's care plan. CMS's pre-hearing brief at 15 - 16. This allegation is incorrect. Petitioner's staff's goal for Resident # 301 was that the resident would receive about 1000 to 1500 cc's of fluid daily. P. Ex. 12-I. Petitioner's staff documented that the resident received at least this quantity of fluid daily. P. Ex. 12-C.

The resident's care plan contains a notation that Petitioner's staff would "Monitor Intake and output, (I > O)." CMS Ex. 20, at 64. CMS asserts that this notation meant that Petitioner's staff would maintain a record of the quantity of fluid excreted by the resident, in addition to maintaining a record of fluid intake. CMS alleges that Petitioner failed to do so.

Petitioner does not deny that it failed to record the quantity of Resident # 301's fluid output. It argues that doing so was not medically necessary and, therefore, there was no potential for the resident to experience harm. Consequently, according to Petitioner, the failure to monitor fluid output was not a quality of care deficiency in contravention of 42 C.F.R. § 483.25.

I find that Petitioner's evidence is persuasive. The resident's treating physician did not order that the resident's fluid output be monitored. P. Ex. 30, at 3. In her opinion, which CMS did not rebut, other treatment activities - including monitoring the resident's fluid intake and weight - were sufficient measures to monitor the resident's hydration status. Id. at 3 - 4. Thus, measuring the resident's fluid output daily was not medically necessary and failure by Petitioner's staff to do so did not adversely affect the quality of care that Petitioner's staff gave to Resident # 301.

d. The preponderance of the evidence does not support a finding that Petitioner failed to comply with the requirements of 42 C.F.R. § 483.25(a)(2).

At issue here is Petitioner's compliance with a regulation that requires a facility give appropriate treatment and services to a resident to maintain or improve, among other things, the resident's ability to eat. 42 C.F.R. § 483.25(a)(2) (which incorporates by reference 42 C.F.R. § 483.25(a)(1)). CMS alleges that Petitioner failed to comply with this regulation in providing care to a resident who is identified in the report of the May survey as Resident # 310. Specifically, CMS asserts that, on February 23, 2005, the resident's physician issued an order that the resident be given a "restorative dining program." CMS Ex. 24, at 7. This order was renewed by the resident's physician on May 4, 2005. However, according to CMS, Petitioner's staff never provided Resident # 310 with restorative dining. CMS asserts that members of Petitioner's staff told surveyors that Petitioner's restorative dining program had been discontinued at some point prior to the May survey due to a staffing shortage. CMS Ex. 9, at 17.

The preponderance of the evidence does not support this allegation. It is unclear what the resident's physician meant by "restorative dining." The term is not defined anywhere in the resident's treatment record and CMS has offered no evidence to establish that the term is a term of art that is widely accepted and understood in the nursing profession to encompass a particular set of services. ⁽¹⁰⁾ Consequently, it is very difficult to decide, on the basis of the evidence offered by CMS, whether Petitioner did or did not provide all of the elements of "restorative dining" to Resident # 310 that were contemplated by the resident's physician when she issued her order.

In the absence of a definition of the term "restorative dining," what I decide is whether Petitioner implemented the physician's specific instructions concerning nutrition - i.e., instructions as to the type or quantity of food that was to be given to the resident - and whether Petitioner complied with applicable standards of nursing care in providing nutrition to the resident. In these regards I find that the preponderance of the evidence establishes that Petitioner's staff implemented the physician's orders and did all that it reasonably could be expected to do to provide nutritional care for Resident # 310. The record therefore does not show that Petitioner neglected the resident's nutritional care in any significant respect.

Resident # 310 was in the last stages of his life at the time of his admission to Petitioner's facility in November 2004 and thereafter. The resident suffered from medical problems that included Parkinson's syndrome, dementia, and frontal lobe bleeding. P. Ex. 16-A, at 12. In January 2005 he was placed into transitional hospice care and in May 2005 into hospice care. ⁽¹¹⁾ Tr. 99; P. Ex. 16-A, at 4; see P. Ex. 30, at 10 - 11. The resident was admitted to a hospital on May 4, 2005 and discharged back to Petitioner's facility on May 12, 2005. CMS Ex. 9, at 17. He died on May 19, 2005. Id. at 16.

The resident manifested problems with his appetite and with ingestion of food throughout his stay at Petitioner's facility. These problems became more serious with the passage of time. The resident declined to eat much of the time and, at the end, declined to eat altogether. ⁽¹²⁾ Beginning in April 2005, Resident # 310 required spoon feeding by Petitioner's staff at least 50 percent of the time. Tr. at 99, 101; P. Ex. 16-B. After his return from the hospital on May 12, 2005, the resident was unable to take anything by mouth. P. Ex. 16-I.

It was in this setting that Petitioner's staff provided care for the resident. Efforts to get the resident to eat included spoon feeding. They also included cueing the resident to eat. Tr. at 118. On January 10, 2005, the resident's physician ordered that the resident be fed a nutritional supplement each morning consisting of "super cereal." CMS Ex. 24, at 3. The resident's physician also ordered that the resident receive pureed food with honey thickened liquids, honey thickened liquids, and orange juice. Id.

There is not a suggestion of evidence in the record of this case to show that the staff failed to offer the nutrition that the physician ordered or that they were less than diligent in attempting to get the resident to eat. First, I do not find the reported statements by members of Petitioner's staff that Petitioner had abandoned its "restorative dining" program to be persuasive proof that Petitioner was less than diligent in providing care to Resident # 310. The alleged statements carry the obvious problem that they are hearsay and unverifiable. More important, the statements do not contain specific information about what Petitioner and its staff did for Resident # 310. Indeed, I have no way of knowing from these reported statements whether the persons who allegedly uttered them were even familiar with Resident # 310's case or the care that he received.

Second, and more important, the documentary record does not support an allegation of deficient care. CMS has identified nothing in the resident's record of care that supports a finding that the resident was not provided the nutrition ordered by the physician, that the staff failed to encourage the resident to eat when necessary, or that the staff failed to provide the resident with supportive care including spoon feeding.

To the contrary, the evidence supports a conclusion that the staff diligently carried out the physician's orders. The efforts of Petitioner's staff to give nutrition to Resident # 310 - in the context of his medical condition - were consistent with applicable standards of nursing care. P. Ex. 29, at 14 - 15.

CMS asserts that the medication administration record (MAR) for Resident # 310 documenting care given to the resident in May 2005 does not show that any "restorative dining" was given to the resident during this period. CMS Ex. 24, at 24. But, as the evidence plainly shows, the resident was incapable of eating during May 2005. Furthermore, there is nothing in the May MAR to suggest that the staff was not doing all that it could do to provide care to the resident given his medical status.

e. The preponderance of the evidence does not support a finding that Petitioner failed to comply with the requirements of 42 C.F.R. § 483.25(h)(2).

The regulation at issue requires that a facility provide each resident with adequate supervision and assistance devices to prevent accidents. CMS alleges that Petitioner was deficient in providing care to two residents, Residents #s 306 and 308. According to CMS, Petitioner failed to comply with its obligation to protect these two residents from risks of falling. CMS alleges that neither of these residents was supplied with fall prevention alarms that had been ordered for them.

As regards Resident # 306, the resident's physician issued an order on April 27, 2005 that the resident have a bed or body alarm at all times. The physician instructed the staff to check the resident for alarm placement at every shift. CMS Ex. 9, at 21. The surveyors who conducted the May survey observed the resident. They found that, at 3:45 p.m. on May 24, 2005, the resident was in bed. No body alarm was in place but there was a bed alarm in place. Additionally, at 8:10 a.m. on May 25, the surveyors observed Resident # 306 to be in the dining room seated in a wheel chair. At that time the resident was not wearing a body alarm. The observation prompted the surveyors to inquire of Petitioner's staff as to why the resident wasn't wearing an alarm. A nurse responded that the certified nursing assistant who was caring for the resident on that morning was from another facility and was unaware that the resident was supposed to be wearing a body alarm. The resident was supplied a body alarm by 9:15 a.m. on May 25. Id.

In the case of Resident # 308, CMS alleges that the resident had a physician's order for a bed alarm. CMS Ex. 9, at 20. On May 25, 2005 the surveyors observed that there was no bed alarm in the resident's bed. Additionally, they had a conversation with a certified nursing assistant who, allegedly, averred that she was unaware that the resident was supposed to have a bed alarm. The nursing assistant allegedly stated that the resident had never had a bed alarm while under that assistant's care. Id. at 19 - 20.

CMS contends that the aforesaid evidence establishes a clear failure on Petitioner's part to provide Residents #s 306 and 308 with assistance devices ordered by the residents' physicians. ⁽¹³⁾ From CMS's perspective the deficiency is obvious. Resident # 308 was not supplied a bed alarm. CMS Ex. 9, at 19 - 20. Additionally, Resident # 306 was not wearing a body alarm on the morning of May 25, 2005 even though the resident's physician had ordered that the resident wear an alarm at all times.

I find that the weight of the evidence establishes that Petitioner was not deficient in providing care to Residents #s 306 and 308. Consequently, I find that Petitioner complied with the requirements of 42 C.F.R. § 483.25(h)(2) in providing care to its residents.

The obvious purpose of ordering that the two residents be supplied with alarms is to protect these residents from injuries sustained from falls. A facility must take reasonable measures to assure that unstable residents do not fall. Providing an unstable resident with an alarm is one possible way of keeping the resident safe. The idea of an alarm is to alert staff that an event is occurring beyond the range of a staff member's immediate vision. If an alarm sounds it alerts the staff that the resident who wears it, but who may be out of the staff's range of vision, is doing something that has triggered the alarm, presumably something that is unsafe for the resident to attempt.

The issue is not so much what type of alarm the resident wears but whether the alarm is reasonably effective in providing the staff with requisite notice of unsafe activity by the resident. If the alarm works as intended its exact nature and mechanism is unimportant to resolving the issue of whether a facility complies with its regulatory obligations.

Here, the evidence establishes that Petitioner's staff frequently opted to use PSAs in lieu of other forms of alarms such as a bed pressure alarm system. P. Ex. 30, at 8; P. Ex. 34, at 2. The evidence establishes that a PSA operates as the functional equivalent of a bed alarm or other types of alarms. It is designed to signal movement by a resident, such as getting out of bed or a wheel chair, and it provides a facility staff with the identical type and quality of notice of movement that other types of alarms provide. P. Ex. 34, at 2; 4 - 16. I find no reason to conclude that Petitioner was deficient because it opted to supply its residents, in particular Resident # 308 (P. Ex. 30, at 9; CMS Ex. 9, at 19), with PSAs.

The weight of the evidence is that Petitioner's staff monitored the residents to assure that the residents had functioning alarms. P. Ex. 29, at 17 - 18. The one exception cited by the surveyors is the failure of Resident # 306 to be equipped with a body alarm during the morning meal on May 25, 2005. However, although that is a failure by Petitioner's staff to comply with the physician's order on that instance, the weight of the evidence establishes that there was no potential for more than minimal harm as a consequence of the omission. The purpose of the alarm was to alert the staff of potentially dangerous movement by a resident when the staff was not in the resident's physical presence. But, when Resident # 306 was in the dining room, unalarmed, on the morning of May 25, 2005, the resident was in the presence of the staff. Thus, an alarm was not a necessary safety feature at that moment. Moreover, Petitioner's staff corrected its error immediately.

CMS asserts that records of routine treatments provided to Residents #s 306 and 308 show that there were nursing shifts in which the residents were not wearing alarms as was ordered by their physicians. See, e.g., P. Ex. 14-C, at 1. These records are the same type of record as is relied on by CMS as proof that Resident # 302's lap buddy was not released periodically. At Finding 2.a., above, I discuss in detail why I find the records of routine treatments not to be persuasive evidence that Petitioner's staff failed to provide care. The same considerations apply here. The fact that a box is not initialed for a particular shift does not, absent some corroborative evidence, satisfy me that a service wasn't provided by Petitioner's staff.

Moreover, a review of the routine treatments report suggests an explanation for many of the "missing" initials that is either benign or favorable to Petitioner. In the case of Resident # 306, the column in the April 2005 routine treatments report that is at issue is at the bottom of the report, containing the handwritten notation "bed alarm." P. Ex. 14-C, at 1. All of the "missing" initials are for either morning (7 -3) or afternoon and evening (3 - 11) shifts. Every box is initialed for the night shift (11 - 7). One obvious possible explanation for the missing initials is that the resident may not have been in bed during those shifts. In the case of Resident # 308, as was the case with Resident # 302, there are scarcely any shifts in which boxes showing the presence of a bed alarm or chair alarm are not initialed. P. Ex. 15-C, at 2. However, on those few occasions where the box is not initialed to show the presence of an alarm, all other boxes for that same shift are not initialed as well. Id. The plausible explanation is that the staff member responsible for the shift simply failed to complete the paperwork.

3. CMS is not authorized to terminate Petitioner's participation in Medicare based on findings of noncompliance made at the May survey.

CMS may not terminate Petitioner's participation in Medicare based on findings of noncompliance that were made at the May survey. That is because the evidence does not establish any actual incidences of substantial noncompliance with participation requirements by Petitioner as of May 26, 2005.

Steven T. Kessel

Administrative Law Judge

1. Petitioner also was surveyed in June 2005 (June survey). However, as of the date of the hearing of this case CMS had not made a remedy determination based on this survey's findings. Consequently, the June survey is not at issue in this case.

2. I extended the offer to CMS to provide rebuttal evidence in a telephone conference that I had with the parties on August 11, 2005.

3. Petitioner argues that, if it was not complying with participation requirements as of May 26, 2005, it became compliant prior to June 27, 2005, the date of termination. I do not need to decide whether Petitioner could avoid termination of participation by correcting its deficiencies prior to the termination date because I conclude at Finding 2 of this decision that Petitioner was, in fact, complying with participation requirements as of May 26, 2005.

4. This contention did not appear in the report of the May survey. See CMS Ex. 9, at 1 - 4. CMS made it for the first time in its pre-hearing brief where it asserted that: "The basis for the deficiency . . . is that petitioner failed to release the lap buddy every two hours, as required . . . ." CMS's pre-hearing brief at 7. I do not find that Petitioner had inadequate notice of CMS's expanded contention inasmuch as I directed CMS to file its pre-hearing brief sufficiently in advance of the hearing so that Petitioner could respond to any allegation that it contained. CMS complied with my directive.

5. CMS did not allege that a failure by Petitioner to document accurately its staff's compliance with the physician's order to release the lap buddy at two-hour intervals would comprise a deficiency under either 42 C.F.R. § 483.13(a) or under some other regulation. For that reason I do not address this question in my decision.

6. I do not suggest that a facility is not obligated to document somewhere in a resident's records changes in care - even minor changes - that it provides to a resident. But, the issue here is whether the facility was obligated to revise residents' care plans pursuant to the requirements of 42 C.F.R. § 483.20(k)(2). That is all that was alleged by CMS and it is all that I address.

7. The reason for moving the resident from a bed to a mattress on the floor is not a mystery and, in fact, it had nothing to do with a significant change in the resident's condition. The purpose was to eliminate the risk that the resident might fall from her bed due to her constant spastic movement. Tr. at 72 - 73.

8. There is a conflict in the record as to precisely when Resident # 301 returned to Petitioner's facility. The hospital record shows the resident as having been discharged on May 3, 2005. However, the resident's treating physician, Mary Preston, M.D., avers that the resident did not return to the facility until May 4, 2005. P. Ex. 30, at 4. I do not find it to be necessary that I resolve this discrepancy.

9. CMS does not allege that Petitioner failed to provide Resident # 301 with adequate nutrition. Its allegations relate only to the way in which Petitioner's staff monitored the resident's nutritional status.

10. CMS adds additional ambiguity by referring to the physician's order, at times, as an order for "restorative nursing." See CMS's pre-hearing brief at 17.

11. I take notice that in order to qualify for hospice care under the Medicare program an individual must be certified to be in the end-stage of his or her life.

12. An NG tube (a form of feeding tube) was inserted into the resident during his May 2005 hospitalization. P. Ex. 16-I. The resident pulled out the tube and, pursuant to the direction of the resident's family, it was not reinserted. CMS Ex. 24, at 15.

13. Resident # 308 sustained a fall on May 24, 2005. CMS does not argue that the fall was the consequence of a failure by Petitioner's staff to provide the resident with required care.