SUBJECT:

Hertiage Manor of Columbia,

Petitioner,

Centers for Medicare & Medicaid Services.

DECISION

I sustain the determination of the Centers for Medicare & Medicaid Services (CMS) to terminate the participation in the Medicare program of Petitioner, Heritage Manor of Columbia. I base this decision on my conclusion that Petitioner failed to comply substantially with two Medicare participation requirements.

I. Background

Petitioner is a skilled nursing facility that is located in Columbia Tennessee. It has participated in the Medicare program. The participation in Medicare of facilities like Petitioner is governed by regulations at 42 C.F.R. Parts 483, 488, and 498.

On September 4 and 5, 2002 (September survey), surveyors employed by the Tennessee Department of Health surveyed Petitioner to determine whether Petitioner was complying with Medicare participation requirements. The surveyors concluded that Petitioner was not complying substantially with nine specific Medicare participation requirements. CMS concurred with these findings and determined to terminate Petitioner's participation in Medicare. Petitioner requested a hearing.

At a previous survey completed in August 2002 (August survey) surveyors concluded that Petitioner also was failing to comply substantially with numerous Medicare participation requirements. CMS determined to impose remedies based on those findings that are in addition to the termination of participation that is at issue here. Petitioner requested a hearing concerning these other remedies and the case was docketed as Civil Remedies Docket No. C-02-849. It is my normal practice to consolidate cases involving different surveys and the same facility so that I may hear and decide them more efficiently. I have not done so here in order that I may issue an expedited decision that addresses only the termination of participation issue.

I note that, as a consequence of the August survey, CMS imposed remedies against Petitioner which included civil money penalties of $3,750 per day for each day beginning with August 15, 2002. CMS subsequently determined that those penalties should continue through September 5, 2002, based in part on the results of the September survey. As I discuss above, I am not at this time deciding whether remedies were appropriate based on the results of the August survey. Nor am I deciding the duration of those remedies including the question of whether civil money penalties in any amount should continue up through completion of the September survey. Obviously, my decision in this case holds that Petitioner was not complying substantially with two participation requirements as of the September survey. I am deferring at this time deciding the scope and severity of these two deficiencies beyond holding that they were substantial because it is unnecessary that I do so to address the issue of whether CMS has the authority to terminate Petitioner's participation in Medicare. My intent is to address that question and to deal with the issue of the amount and duration of civil money penalties in a subsequent decision in which I also address the deficiency findings that were made at the August survey.

I conducted an expedited hearing in Nashville, Tennessee, on October 22, 2002. At the hearing I received into evidence exhibits from CMS consisting of CMS Ex. 17 - CMS Ex. 43 and CMS Ex. 47 - CMS Ex. 52. I received into evidence exhibits from Petitioner consisting of P. Ex. 1 - P. Ex. 43. I heard cross-examination and redirect testimony of several witnesses (I received these witnesses' written direct testimony as part of the exhibits that I received into evidence).

Prior to the hearing Petitioner filed two motions addressing legal issues. It moved that I reject the noncompliance allegations made at Tag 309 of the report of the September survey on the ground that the regulation to which these allegations relate - 42 C.F.R. § 483.25 - is so vaguely worded that it fails to establish criteria against which Petitioner's compliance may be measured. And, it asserted that the Departmental Appeals Board had unfairly assigned to Petitioner the burden of proving its compliance with participation requirements. I denied these motions on the record of the hearing. Tr. at 8 - 11.

II. Issue, findings of fact and conclusions of law

A. Issue

The issue in this case is whether, as of September 5, 2002, Petitioner was not complying substantially with one or more federal participation requirements, thereby authorizing CMS to terminate Petitioner's participation in Medicare.

B. Findings of fact and conclusions of law

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

1. CMS may terminate a skilled nursing facility's participation in Medicare if the facility is not complying substantially with one or more Medicare participation requirements as of the date of termination.

As I discuss above, CMS determined to terminate Petitioner's participation in the Medicare program based on its conclusion that, as of September 5, 2002, Petitioner was not complying substantially with nine separate Medicare participation requirements. CMS concluded that the level of Petitioner's noncompliance with several of these requirements was so serious as to comprise immediate jeopardy for residents of Petitioner.

To conclude that CMS is authorized to terminate Petitioner's participation in Medicare, I need not decide that Petitioner failed to comply with every one of the nine participation requirements alleged by CMS. As a matter of law, CMS is authorized to terminate a skilled nursing facility's participation in Medicare if that facility fails to comply substantially with just one Medicare participation requirement. Social Security Act (Act), section 1866(b)(2)(A). Nor is it necessary for me to decide that Petitioner's noncompliance with any of the nine requirements that are at issue was so severe as to put residents at immediate jeopardy. Id. A basis to find failure to comply substantially with a participation requirement exists if it is shown that the noncompliance poses a potential for more than minimal harm to residents of a facility. 42 C.F.R. § 488.301.

2. The record of this case establishes that Petitioner failed to comply substantially with two participation requirements as of September 5, 2002.

In this Finding I analyze the evidence that pertains to each of the nine participation requirements with which Petitioner allegedly failed to comply substantially as of the September survey. I decide that Petitioner failed to comply substantially with two participation requirements. These requirements are stated at 42 C.F.R. § 483.25(c), (pressure sores), and at 42 C.F.R. § 483.25(l)(1) (unnecessary drugs). In all other respects, Petitioner either complied substantially with participation requirements or CMS failed to establish a prima facie case that Petitioner did not comply.

a. CMS failed to establish a prima facie case that Petitioner failed to comply substantially with the requirements of 42 C.F.R. § 483.13(b).

At Tag 223 of the report of the September survey the surveyors alleged that Petitioner failed to comply substantially with the requirements of 42 C.F.R. § 483.13(b). The regulation provides that a resident of a facility has the right to be free from verbal, sexual, physical, and mental abuse, corporal punishment, and voluntary seclusion. The word "abuse" is defined at 42 C.F.R. § 488.301 to mean:

the willful infliction of injury, unreasonable confinement, intimidation, or punishment with resulting physical harm, pain or mental anguish.

The surveyors alleged that Petitioner allowed one of its employees, a licensed practical nurse, to "yell" at and to threaten a resident and to talk roughly to two other residents. Additionally, the employee in question is alleged to have administered insulin to a resident without simultaneously offering food to that resident and to have brought a breakfast tray late to that same resident. The surveyors alleged also that these alleged acts of abuse violated a plan of correction in which Petitioner pledged that it would have zero tolerance of abuse. CMS Ex. 21 at 1 - 2.

I am not persuaded that these allegations make out a prima facie case that Petitioner tolerated abuse at its facility. I find the allegations not to be credible because they rely entirely on hearsay complaints of residents that are unsupported by any corroborating evidence. Furthermore, the allegations of abuse are vague and fail to describe the allegedly abusive speech with sufficient clarity so that I might decide whether the allegedly abusive speech and conduct, even if it occurred, was actually "willful infliction of injury." See 42 C.F.R. § 488.301.

I routinely admit hearsay evidence in hearings involving CMS. The traditional reason for not admitting hearsay - that members of a jury might be prejudiced by evidence that is inherently unreliable - is not a factor in these cases. However, the fact that I admit hearsay does not mean that I find it necessarily to be credible. There are valid reasons which underlie a general rule of evidence against admitting hearsay. Much hearsay is unreliable. I find that to be the case with the hearsay statements that support the allegations that are the basis for Tag 223 of the September survey report.

The principal problem with relying on the hearsay complaints of residents is that there is no viable way to test the credibility of these residents' statements. These are individuals who, by definition, are too ill to be able to move about freely in public. It would hardly be realistic to subject these individuals to rigorous cross-examination. Consequently, if CMS is to rely on hearsay as support for its contentions, it needs to buttress such statements with corroborative evidence that either enhances the reliability of the hearsay or provides independent support for those contentions. CMS has provided nothing of that sort here.

The hearsay statements of Resident # 17 are the principal support for the abuse allegations that are made at Tag 223. The statements of Resident # 17 are neither inherently credible nor supported by corroborating evidence. Far from being buttressed, the statements are vitiated by evidence which shows the resident to be an unreliable reporter. The resident suffers from emotional problems that call into serious question the veracity of her complaints. On August 27, 2002, just one week prior to the survey, a psychologist found the resident to be anxious, ruminating, tearful, and to display delusional thinking. P. Ex. 6, at 1. The psychologist observed that the resident:

has become progressively more anxious [and] isolated, [and] at times distorts reality [and] imagines staff deals [with] her inappropriately.

Id. at 2.

Additionally, I have no idea from the hearsay accounts in the survey report exactly what the alleged statements by the nurse were that prompted the residents' complaints. There is no description of the circumstances in which the statements allegedly were made. Thus, I cannot tell what the complaining residents meant when they alleged that the nurse yelled, threatened, or talked roughly. It is not clear from the report whether the allegedly abusive speech - assuming that the nurse uttered anything that could be characterized as uncivil or inappropriate - was directed at specific residents or was intended to intimidate them.

Finally, some of the conduct alleged by the complaining residents is not, on its face, abusive even if it occurred. I can discern no reason why administering insulin without simultaneously providing food or bringing a breakfast tray late should be characterized as abuse in the absence of any evidence of the allegedly offending nurse's intent. CMS has offered no prima facie evidence that the complained-of care even violated accepted standards of care in administering insulin. And, it has offered nothing to show why this conduct, assuming it to have occurred, evidences willful efforts to injure a resident.

b. Petitioner complied substantially with the requirements of 42 C.F.R. § 483.20(k)(2).

At Tag 280 of the report of the September survey the surveyors alleged that Petitioner was not complying substantially with the requirements of 42 C.F.R. § 483.20(k)(2). This regulation states that, for each resident of a facility:

a comprehensive care plan must be -

(i) Developed within 7 days after completion of the comprehensive assessment;

(ii) Prepared by an interdisciplinary team, that includes the attending physician, a registered nurse with responsibility for the resident, and other appropriate staff in disciplines as determined by the resident's needs, and, to the extent practicable, the participation of the resident, the resident's family or the resident's legal representative; and

(iii) Periodically reviewed and revised by a team of qualified persons after each assessment.

The allegations of noncompliance in the survey report center on the care that Petitioner provided to five of its residents, who are identified as Residents #s 7, 8, 9, 11, and 19. CMS Ex. 21 at 2 - 6. The report asserts that Petitioner failed adequately to revise the care plans of these residents. Id. at 2, 4. The specific allegations are that:

• Resident # 9 was observed on September 4, 2002 to have a new pressure sore on the top of the resident's ear. The surveyors brought this to the attention of Petitioner's nursing staff. However, as of September 5, 2002, no dressing had been applied to the resident's ear, the oxygen tubing that passed behind the ear had not been padded, no nursing or physician's notes had been generated, no physician's order had been issued for the resident, there was nothing on the activities of daily living flow sheet that addressed the pressure sore, and the resident's plan of care had not been revised. Furthermore, there had been no documented skin assessments made for the resident on August 14 or September 4, 2002 (assessments were done on August 7, 21, and 28, 2002). Id. at 4.

• Resident # 11 was observed on September 4, 2002 to have a new pressure sore on the inner aspect of the resident's right large toe. The surveyors brought this to the attention of Petitioner's nursing staff. As of September 5, 2002, no dressing had been put on the injury. The surveyors found no nursing note, no physician's note, no order from a physician, no entry on the resident's treatment sheet, and no entry made on the resident's activities of daily living flow sheet. No revisions had been made to the resident's plan of care. Although a skin assessment had been documented for the resident on August 28, 2002, none had been documented on August 14, 2002 or on September 4, 2002. Id. at 4 - 5.

• The care plan for Resident # 7 had not been revised for this resident to deal with problems of constipation, impaction, or skin breakdown. Id. at 5.

• The care plan for Resident # 8 had not been revised to deal with recurring problems of impaction and constipation. Id. at 5.

• The care plan for Resident # 19 had not been revised to deal with a pressure ulcer that had developed during the two weeks that predated the September survey. Id. at 5 - 6.

I find that the survey report's allegations with respect to Residents #s 9 and 11 do not state a prima facie case that Petitioner failed to comply with the requirements of 42 C.F.R. § 483.20(k)(2). Many of the allegations concerning Petitioner's alleged failure to give care to these residents are irrelevant to the question of whether Petitioner revised the residents' plans of care in accord with the requirements of the regulation. The regulation does not address documentation of nurses' or physicians' notes or orders, or updates of activities of daily living flow sheets. Consequently, Petitioner's alleged failure to maintain or update such documents is not reason to conclude that it failed to update timely its residents' plans of care. Nor does the regulation address directly the care that a facility gives to its residents. Arguably, Petitioner should have provided treatment to Residents #s 9 and 11 as soon as problems were brought to Petitioner's staff's attention by the surveyors. But, the alleged failure of Petitioner to provide that care is irrelevant to the issue raised under Tag 280, which is whether Petitioner made updates to these residents' plans of care in accordance with the requirements of 42 C.F.R. § 483.20(k)(2).

The allegations that are made concerning Residents #s 9 and 11 which are relevant - that Petitioner failed timely to update these residents' plans of care - fail because CMS has not established the criteria that a facility must follow in updating care plans. I infer from the survey report that the surveyors, and CMS, are alleging that Petitioner violated the requirements of 42 C.F.R. § 483.20(k)(2) because it did not update the care plans of Residents #s 9 and 11 immediately after the surveyors advised Petitioner's staff that the residents had developed pressure sores. But, the regulation contains no such requirement. It merely states that care plans must be reviewed and revised "periodically." 42 C.F.R. § 483.20(k)(2)(iii). Absent any definition of the term "periodically" one logically would look to applicable standards of nursing care in order to decide what the term means in the context of development of a new pressure sore by a facility resident. But, CMS has provided no evidence as to what comprises the applicable standard. I can discern nothing in the record of this case to suggest that a facility would be remiss if it waited more than 24 hours to revise a resident's plan of care after the facility's staff learned that the resident had developed a pressure sore.

Moreover, the regulation suggests that revisions to plans of care need not be made instantaneously or nearly so. The regulation requires that plans of care be reviewed and revised periodically "by a team of qualified persons after each assessment." 42 C.F.R. § 483.20(k)(2)(iii). That language suggests that a care plan revision needs to be made after a thorough review by a team of medical professionals. The language does not suggest that such teams can or should be convened on very short notice to address every problem that a resident may manifest.

I find that Petitioner rebutted, by the preponderance of the evidence, the allegations of noncompliance that the surveyors made with respect to Residents #s 7 and 8. Petitioner produced plan of care revisions for Residents #s 7 and 8, showing that each of these residents' plans of care had been reviewed and revised shortly prior to the September survey. P. Ex. 12; P. Ex. 41, at 12.

As for Resident # 19, CMS introduced no evidence to support the statement in the report of the September survey that the resident had developed a pressure ulcer within the two weeks prior to the survey. See CMS Ex. 21, at 5. This allegation is thus uncorroborated and unsubstantiated. However, Petitioner introduced evidence showing that the resident denied that she had developed a pressure ulcer. P. Ex. 11. More significantly, the resident's charge nurse averred that, to her knowledge, the resident had never experienced a skin breakdown. Id.; see P. Ex. 41, at 11. >From this evidence I conclude that Petitioner was not remiss in its care planning for Resident # 19.

c. CMS failed to establish a prima facie case that Petitioner failed to comply substantially with the requirements of 42 C.F.R. § 483.20(k)(3)(i).

At Tag 281 of the report of the September survey the surveyors alleged that Petitioner failed to comply substantially with the requirements of 42 C.F.R. § 483.20(k)(3)(i). CMS Ex. 21, at 6 - 8. The regulation mandates that the services that are provided by a facility must meet professional standards of quality. The surveyors asserted that Petitioner failed to meet professional standards of quality in providing care to three residents, identified in the survey report as Residents #s 3, 19, and 20. Id. at 6. The surveyors made the following allegations with respect to the care that Petitioner gave to these three residents.

• Resident # 3 was admitted to Petitioner's facility on January 3, 2002, suffering from ailments which included congestive heart failure and possible pneumonia. The resident had a history of congestive heart failure. Petitioner's staff made an admission assessment nursing note for Resident # 3 on January 3, 2002, but made no further documentation of the resident's condition until January 7, 2002. On January 8, 2002, a nursing note showed that the resident was making gurgling sounds and spitting up clear sputum. No additional documentation was made until January 9, 2002 when the resident was noted to be having coughing spasms. On January 10, 2002, Petitioner's staff noted worsening of the resident's condition and attempts were made to contact the resident's physician. Several unsuccessful attempts were made until an on-call physician was contacted. The physician ordered that the resident be sent to a hospital emergency room. The resident was admitted to a hospital on January 10, 2002 and expired on January 15, 2002. CMS Ex. 21, at 6 - 7.

• Petitioner submitted a plan of correction after the August survey in which it averred that it would utilize a pain management flow sheet to manage the pain of those residents who were documented as experiencing pain daily. Review of the records of Residents #s 19 and 20 revealed that these residents were receiving scheduled pain medications. However, no pain management flow sheets had been prepared for these residents. CMS Ex. 21, at 8.

The allegations that were made with respect to Resident # 3 do not establish a prima facie case that Petitioner failed to provide care that met accepted standards of quality as of September 5, 2002. First, it is unclear from these allegations exactly what it is that Petitioner did or failed to do in providing care to the resident that did not comply with accepted standards of quality. CMS has not offered any prima facie proof to establish what documentation standards would apply to a resident who was suffering from the ailments that beset Resident # 3. Nor has it offered prima facie evidence that Petitioner was derelict in providing care to the resident.

The surveyors' summary of events suggests that Petitioner's staff was diligent in attempting to contact the resident's physician when the resident's condition worsened beginning on January 10, 2002. It is unclear from the survey report that accepted standards of care would have required Petitioner's staff to attempt to notify the physician sooner. Nor has CMS pointed to evidence that is independent from the survey report that would support a conclusion that Petitioner was remiss in providing care to the resident.

Significantly, the events described in the survey report pertaining to Resident # 3 occurred in January 2002, nearly eight months prior to the September survey. I find that these events - even if they arguably show some failure to provide care that met accepted standards of care - are so remote in point of time as to say nothing meaningful about the quality of care that Petitioner was providing in September 2002.

I also conclude that the allegations that are made with respect to the care that Petitioner provided to Residents #s 19 and 20 do not establish a prima facie case of noncompliance with the requirements of the regulation. There is nothing in the regulation that requires that pain management flow sheets be completed for residents of a facility who complain of pain daily. Moreover, a failure by Petitioner to comply with its plan of care or its own internal policies is not, per se, a violation of a regulation.

Arguably, professionally recognized standards of nursing care might require that such sheets, or something like them, be completed. But, CMS has offered no prima facie evidence that such is required. Moreover, CMS has offered no prima facie evidence that the residents failed to receive medications when needed, or that Petitioner's staff was inattentive to the residents' complaints of pain.

Although CMS did not prove a prima facie case that Petitioner was deficient in the pain management care that it gave to Residents #s 19 and 20, Petitioner offered evidence to show that it was attentive to the residents' needs, including documenting administration of pain medications to the residents. P. Ex. 15; P. Ex. 16; P. Ex. 41, at 13 - 14.

d. Petitioner complied substantially with the requirements of 42 C.F.R. § 483.25.

At Tag 309 of the report of the September survey the surveyors alleged that Petitioner failed to comply substantially with the requirements of 42 C.F.R. § 483.25. CMS Ex. 21, at 8 - 10. The regulation requires a facility to provide each of its residents with the necessary care and services 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 surveyors alleged that Petitioner failed to provide care and services to one resident - identified in the survey report as Resident # 21 - that were necessary to maintain the resident's highest practicable physical, mental, and psychosocial well-being. According to the surveyors, the resident suffered from a severe decline during the week preceding the September survey. Id. at 10. They asserted that Petitioner failed to assess the resident's allegedly severe decline in a timely manner and failed to administer treatments that were prescribed by the resident's physician. Id. To support these assertions the surveyors made the following allegations of fact:

• On September 4, 2002, a member of the resident's family told a surveyor that another member of the resident's family had told him or her that the resident's condition had "declined severely in the last week." The family member averred that the family had not been notified of any change in the resident's condition. Id. at 9.

• A surveyor observed the resident at 9:50 a.m. on September 4. The resident appeared to be confused, lethargic, and extremely weak. According to the resident's family member, the resident's condition as of September 4 represented a "big change" in the resident's functioning from the previous week. An interview between a surveyor and an unnamed licensed practical nurse revealed that the resident had a decline in the activities of daily living over the "last few days." Id.

• The most recent nursing note pertaining to Resident # 21 had been prepared on August 28, 2002. That note indicated that the resident was resting quietly at that time and was not complaining of pain. Id.

• The licensed practical nurse had requested a physician examine the resident on the evening of September 3, 2002 because of the resident's decline. On September 3, 2002 a physician issued an order that Petitioner's staff take the resident's vital signs every four hours, obtain a complete blood count (CBC), a chemistry panel, a urinalysis, and a chest x-ray. The physician also directed that the resident be administered an antibiotic once per day. Id.

• No vital signs were recorded for the resident after August 28, 2002. Id.

• Petitioner's staff did not administer the antibiotic on September 3, 2002. The antibiotic had not been administered as of the time the licensed practical nurse was interviewed on September 4, 2002. Petitioner's unit manager and pharmacist agreed in interviews that the appropriate procedure should have been to initiate treatment with the antibiotic on the evening of September 3, 2002. Id. at 10.

• Petitioner's staff transferred the resident to a hospital at 10:45 a.m. on September 4, 2002, after a family member became very upset and insisted that the resident be transferred to a hospital. Id. at 9. As of September 5, 2002, the resident remained in the hospital. Id. at 10.

The surveyors relied heavily on uncorroborated hearsay accounts to depict Resident # 21's condition as declining precipitously without intervention by Petitioner's staff in the week that preceded the September survey. I do not find these accounts credible because they are unverified hearsay. There is simply no way to ascertain the credibility of the anonymous member of the resident's family who asserted that the resident had suffered a major decline in the week prior to the survey. Equally, it is impossible to ascertain the credibility of the account that the anonymous family member attributed to a second anonymous family member.

Indeed, the allegations that the resident suffered a precipitous and unassessed decline while under Petitioner's care are not supported by the credible evidence of record. In that regard I find to be persuasive the opinion expressed by Gibran Naddy, M.D., the resident's treating physician, and Petitioner's medical director, that Resident # 21 did not suffer a severe decline that Petitioner failed to assess. P. Ex. 39, at 2.

There are some allegations at Tag 309 of the survey report that I find to be credible. These are the allegations that Petitioner's staff failed to record the resident's vital signs after being instructed specifically to do so by the resident's treating physician, and failed to administer antibiotics to the resident immediately after they were prescribed. These assertions are based on reviews of the resident's record at Petitioner's facility.

However, close review of the evidence fails to establish grounds for concluding that Petitioner was derelict in providing care to Resident # 21. Petitioner has not disputed the assertion that its staff failed to record the resident's vital signs between the evening of September 3, 2002 and September 4. However, there is no evidence in this case from which I can gauge the significance of this failure. Consequently, I cannot conclude that the failure to record the resident's vital signs posed a potential for more than minimal harm to the resident.

The applicable regulation - 42 C.F.R. § 483.25 - contains no standard that defines what a facility must do to provide "necessary" care that enables a resident to attain the maximum level of physical, mental, and psychosocial well-being. In fact, Petitioner premised its motion to dismiss the allegations that were made at Tag 309 of the September survey report on the failure of the regulation to define "necessary." In denying that motion I held that the absence of an explicit definition in the regulation did not mean that the regulation was defective. It meant that professionally accepted standards of care are incorporated into the regulation to define what would be necessary in a particular situation. Failure to provide care that professionally recognized standards of nursing define as necessary would be a substantial violation of the regulation. See 42 C.F.R. § 488.301.

The absence of a specific standard in the regulation imposes on CMS a duty to explain what the applicable standard of care consists of. That obligation is part of CMS's overall duty to present a prima facie case of noncompliance. As an element of this duty CMS must make a prima facie showing that any noncompliance it identifies is substantial.

CMS did not meet its obligations here. Evidence is lacking to show what are the professionally recognized standards of care that govern a facility's obligation to take a resident's vital signs. Is failure to record Resident # 21's vital signs between the evening of September 3, 2002 and the morning of September 4, 2002 a violation of accepted nursing standards? CMS has offered no affirmative proof to establish that, in the context of this case and given the clinical evidence relating to this resident, failure to record the resident's vital signs during the time period at issue posed a potential for more than minimal harm to the resident. For these reasons I cannot infer that Petitioner's failure to record the vital signs of Resident # 21 during the evening of September 3, 2002 and the morning of September 4, 2002 constituted a substantial failure to comply with the requirements of 42 C.F.R. § 483.25.

Petitioner rebutted the remaining allegations of noncompliance that were made at Tag 309. Petitioner's explanation for delaying administration of antibiotics from the evening of September 3, 2002 until after it had received the results of the urinalysis is plausible and a reasonable explanation for its staff's not immediately beginning to administer antibiotics to Resident # 21. P. Ex. 18; P. Ex. 41, at 15. The resident's physician did not specifically instruct Petitioner's staff as to when to begin administering antibiotics to the resident. P. Ex. 39 at 2. As the resident's nurse explained, absent an instruction that antibiotic administration begin immediately, it was a reasonable exercise of the nurse's judgment to defer beginning to administer antibiotics to the resident until a urinalysis of the resident had been completed. P. Ex. 18; P. Ex. 41, at 15; P. Ex. 39, at 2 - 3.

e. Petitioner failed to comply substantially with the requirements of 42 C.F.R. § 483.25(c) .

At Tag 314 of the report of the September survey the surveyors alleged that Petitioner failed to comply substantially with the requirements of 42 C.F.R. § 483.25(c). CMS Ex. 21, at 10 - 14. This regulation requires that, based on a resident's comprehensive assessment, a facility must ensure that a resident who enters a facility without pressure sores does not develop them unless the resident's clinical condition demonstrates that they were unavoidable. It requires additionally that a resident having pressure sores receives necessary treatment and services to promote healing, prevent infection, and to prevent new pressure sores from developing.

The surveyors who conducted the September survey alleged that Petitioner failed to prevent three residents from developing pressure sores. These residents are identified in the survey report as Residents #s 9, 11, and 22. CMS Ex. 21, at 12. Specifically, the surveyors alleged the following:

• On September 4, 2002, observation of Resident # 9 revealed the presence of a new Stage II pressure sore on the top of and behind the resident's right ear. The sore appeared to be caused by rubbing from oxygen tubing. The surveyor immediately brought the sore to the attention of Petitioner's staff. However, on September 5, the sore had not been treated. There was no physician's note, no physician's order, no addenda to the resident's treatment sheets, and nothing in the resident's activities of daily living flow sheet addressing the pressure sore. Nor had the resident's plan of care been updated to address the pressure sore. Finally, although skin assessments were done of the resident on August 7, August 21, and August 28, 2002, none had been documented on August 14 or on September 4, 2002. Id.

• On September 4, 2002, observation of Resident # 11 revealed the presence of a new pressure sore approximately 1/4 inch in diameter on the inner aspect of the resident's right large toe. The surveyor immediately brought the sore to the attention of Petitioner's staff. On September 5, 2002, the sore had been treated. However, there was no nursing note, no physician's note, no addenda to the resident's treatment sheets, and nothing in the resident's activities of daily living flow sheets addressing the sore. The resident's care plan had not been revised to address the pressure sore. A skin assessment had been done of the resident on August 28, 2002, but not on August 14, 2002 nor on September 4, 2002. Id. at 12 - 13.

• Review of the treatment record of Resident # 22 established that, on September 3, 2002, Petitioner's staff identified a pressure sore on the resident's right buttock. Observation of the resident on September 5, 2002 confirmed the presence of the sore and established it to be a four centimeter wide Stage II pressure sore. Additional record review established that the resident previously had a sore at the same location which had healed as of August 21, 2002. There was no documentation in the resident's record that showed ongoing skin assessments to prevent further breakdown of the resident's skin. Id. at 13.

• Petitioner failed to follow its previously submitted plan of correction addressing the care it would provide to residents to prevent skin breakdowns. CMS Ex. 21 at 13 - 14. Specifically, the plan of correction averred that Petitioner's staff nurses would prepare care plans dealing with skin breakdowns and that unit managers and charge nurses would monitor these documents for implementation. Allegedly, Petitioner failed to implement this provision of its plan. Id.

It is not entirely clear from the survey report or from the evidence offered by CMS whether CMS is alleging that Petitioner failed to prevent residents from developing pressure sores that were avoidable, whether Petitioner failed to treat pressure sores that had developed, or both. However, for sake of analysis, I am assuming that the allegations are that Petitioner failed both to prevent the development of avoidable sores and to treat those sores that its residents developed.

The evidence cited by CMS is prima facie proof that both Residents #s 9 and 11 developed injuries to their skin that were observed by surveyors. It is also prima facie proof that Petitioner's staff allowed these injuries to go untreated for at least a full day after the staff was notified by the surveyors about the existence of the wounds. Petitioner has offered no evidence to dispute the surveyors' allegations that the residents had the injuries that are identified in the survey report. Nor has Petitioner offered any evidence to rebut the allegations that it failed to treat these wounds. Rather, Petitioner disputes that these injuries - particularly that which was developed by Resident # 11 - actually constituted pressure sores. It argues that the wound experienced by Resident # 9 was merely an "abrasion." Tr. at 57, 59 - 60. And, it asserts that the injury experienced by Resident # 11 was some sort of traumatic injury to the resident's toe and not a pressure sore. Id. at 60. It contends that it is excused from having to comply with the requirements of the pressure sore regulation insofar as the care given to Residents #s 9 and 11 is concerned if, in fact, the injuries suffered by the residents are not pressure sores.

I disagree with Petitioner's analysis. In my judgment it does not matter whether the injuries that were experienced by the two residents met the clinical definition of pressure sores. Indeed, neither party has supplied me with evidence showing what the clinical definition of a pressure sore is, so it would be difficult in any event for me to make findings as to whether these injuries were pressure sores. What does matter is that the facility failed to deal with these wounds at all despite being put on notice by the surveyors that the residents had injuries which could have been pressure sores.

The central evidence that CMS offered and which Petitioner did not rebut shows that both Resident # 9 and Resident # 11 had wounds which surveyors - who are trained nurses - identified to be pressure sores and which these surveyors brought to the attention of Petitioner's staff. Notwithstanding, Petitioner had provided no care whatsoever to either of these residents' wounds a full day after the wounds had been brought to its staff's attention.

The requirements of 42 C.F.R. § 483.25(c) that a facility take measures to prevent and to treat pressure sores would be rendered largely meaningless if a facility could measure its performance by hindsight. The regulation clearly requires a facility to treat wounds that might be pressure sores as if they are pressure sores. Otherwise, wounds that are in fact pressure sores could go untreated. Here, both Resident # 9 and Resident # 11 had injuries which clearly could have been pressure sores. Indeed, professionally trained nurses concluded that the wounds were pressure sores. Petitioner had an affirmative duty to provide care to these residents as soon as the presence of these possible sores had been brought to its staff's attention. The failure by Petitioner's staff to provide any care to these residents - including a failure to at least consider whether to seek a physician's advice as to whether the injuries were pressure sores and to administer care consistent with the physician's advice - constituted a failure by Petitioner and its staff to take measures to treat the wounds, to promote healing, and to prevent the development of pressure sores in the future.

There is no dispute that Resident # 22 - the third resident whose care is at issue under Tag 314 - developed a pressure sore. See P. Ex. 39, at 4. But, Petitioner vigorously takes issue with CMS's apparent assertion that the sore was avoidable. Nor does Petitioner agree that it failed to provide the resident with necessary care.

An unavoidable pressure sore is one that develops despite implementation of reasonable measures that are intended to prevent the development of sores. Wellington Specialty Care & Rehabilitation Center, DAB CR548 (1998). Resident # 22 was gravely ill, near death, and it is possible that no level of care would have prevented the resident from developing a pressure sore. On August 23, 2002, Resident # 22 was designated as "DNR" (do not resuscitate) and comfort care only measures were instituted for her. P. Ex. 39, at 4. But, that did not excuse Petitioner's staff from taking reasonable measures designed to prevent the resident from developing pressure sores. Petitioner owed that duty to its residents, including Resident # 22, regardless of the resident's medical condition.

It is impossible to say that the sore that the resident developed after August 21, 2002 was unavoidable in light of Petitioner's failure to take measures that were designed to prevent the resident from developing additional sores. Petitioner's staff knew the resident was at risk for developing a pressure sore on her buttock because the resident had a history of having a pressure sore in that area. The evidence offered by CMS - which Petitioner did not rebut - is that Petitioner did not undertake any measures designed to prevent the resident from developing additional sores between August 21, 2002 and September 3, 2002, when the new sore was identified, even though Petitioner's staff knew that the resident was at risk for developing a sore.

The fact that the resident was terminally ill and that a physician had issued a "do not resuscitate" order for the resident provides Petitioner with no justification for failing to take reasonable measures that were designed to prevent Resident # 22 from developing additional pressure sores. A diagnosis that a resident has a terminal illness does not excuse a facility from providing needed care.

f. Petitioner complied substantially with the requirements of 42 C.F.R. § 483.25(j).

At Tag 327 of the report of the September survey the surveyors alleged that Petitioner failed to comply substantially with the requirements of 42 C.F.R. § 483.25(j). CMS Ex. 21, at 14 - 15. The regulation requires that a facility provide each of its residents with sufficient fluid intake to maintain proper hydration and health. The surveyors alleged that Petitioner failed to comply with the requirements of the regulation in that it failed adequately to monitor the fluid intake of a resident who is identified in the survey report as Resident # 14.

The surveyors made the following specific allegations to support their overall allegation of noncompliance:

• The resident had a history of fecal impaction. In a plan of correction dated August 27, 2002, Petitioner pledged that residents with histories of fecal impaction and/or constipation would be assessed and measures would be implemented to prevent recurrences. Additional measures promised by Petitioner included monitoring of residents' bowel movements and treatment of a resident who had not had a bowel movement at least once in three days. Id. at 14.

• The resident had not had a bowel movement between August 16, 2002 and August 21, 2002. During this period documentation by Petitioner's staff was inconsistent and no documentation was made on August 21, 2002. Petitioner had not implemented its protocol for dealing with impaction and/or constipation with respect to Resident # 14. Id. at 14 - 15.

• There was no reassessment of the resident's hydration needs and monitoring of the resident's intake and output of fluids was sporadic. Id. at 15.

The allegations make out a prima facie case that Petitioner failed to comply with the requirements of 42 C.F.R. § 483.25(j) in providing care to Resident # 14. The evidence offered by CMS shows that this resident had hydration problems. Yet, Petitioner failed to monitor closely the resident's intake and output of fluids.

Petitioner does not deny the specifics of the allegations. Instead, Petitioner contends that Resident # 14 was close to death during the time period that CMS asserts that Petitioner's staff were derelict in fulfilling their obligations to the resident. The resident died on August 30, 2002. Petitioner argues that it would have been senseless for its staff to attempt to monitor and to adjust the resident's hydration in light of the resident's condition and the resident's final wishes.

I find that Petitioner rebutted CMS's prima facie evidence of noncompliance by the preponderance of the evidence. I do not conclude that a facility has no duty to assure that a terminally ill resident is adequately hydrated. The regulation makes it plain that the duty extends to all residents regardless of their medical condition. But here, compliance with the final wishes of the resident made it impossible for Petitioner to carry out its duties.

The evidence shows that, in the final days of the resident's life Resident # 14 asked Petitioner's staff to discontinue the administration of fluids. On August 23, 2002, the resident expressed a desire to no longer have per-mouth intake. The resident refused intravenous fluids as well. P. Ex. 24, at 2. Compliance with those wishes meant that the resident would not receive fluids. Unless the facility were to disregard the resident's wishes and force the resident to consume fluids there was nothing that the facility could do to assure that the resident received adequate hydration. I do not find that the regulation requires a facility to force a resident to consume fluids against the resident's will.

g. Petitioner failed to comply substantially with the requirements of 42 C.F.R. § 483.25(l)(1).

At Tag 329 of the report of the September survey the surveyors alleged that Petitioner failed to comply substantially with the requirements of 42 C.F.R. § 483.25(l)(1). CMS Ex. 21, at 15 - 17. The regulation provides that the drug regimen of each resident of a facility must be free from unnecessary drugs. It defines an unnecessary drug to be any drug that is used: in excessive dose; or for excessive duration; or without adequate monitoring; or without adequate indications for its use; or in the presence of adverse consequences which indicate that the dose should be reduced or discontinued; or for any combination of the aforesaid reasons.

The surveyors alleged that Petitioner's staff failed to assess adequately the need for and to monitor the behaviors of two residents who were taking psychotropic medications. These residents are identified in the survey report as Residents #s 7 and 21. Specifically, the surveyors alleged that:

• Resident # 21 was admitted to Petitioner's facility on March 1, 2002 with diagnoses that included dementia and depression. The resident had received Zyprexa and Depakene since April 29, 2002. I take notice that Zyprexa and Depakene are psychotropic medications. No initial assessment was made to determine the resident's need for these medications. The resident had a care plan dated June 18, 2002 which directed Petitioner's staff to observe the resident for signs and symptoms of adverse reactions to medications and to monitor the effectiveness of medications. However, no behavior monitoring had been done of the resident since the initiation of drug therapy. There was no recommendation from Petitioner's consultant pharmacist to initiate behavior monitoring although a plan of correction that is dated August 27, 2002 stated that Petitioner's pharmacy consultant would monitor residents for appropriate use of antipsychotic medications. Id. at 16.

• Resident # 7 was placed on Risperdal on July 27, 2002. I take notice that Risperdal is a psychotropic medication. The resident manifested no behavior that would indicate a need for the medication. No assessment was made that documented the need for the medication. Id. at 17.

These allegations establish a prima facie case of noncompliance with the requirements of the regulation. If not rebutted, they show that Petitioner failed to assess or monitor residents in order to determine whether the residents needed to take psychotropic medications. In the absence of such assessments it would be impossible for Petitioner's staff to discharge its duty under the regulation to assure that residents did not receive unnecessary medications.

I find that Petitioner did not rebut these allegations. Petitioner failed to show that it was taking meaningful measures to evaluate either of the two residents to determine whether the drug dosages they were receiving were appropriate for their respective conditions.

Petitioner argues that both residents received psychotropic medications based on their medical histories and on evaluations and prescriptions by physicians. That may be so, but it begs the question of whether Petitioner fulfilled its obligations to the residents. The regulation imposes a duty on a facility independent of that which is assumed by the resident's physician. Under this regulation the facility's staff is charged with performing a function that augments the physician's care. In assessing its residents for the need for initiating or continuing drug therapy a facility provides the physician with important information that he or she may need to make a judgment about whether to prescribe medication. Here, Petitioner failed to provide that assistance.

Second, Petitioner argues that the failures to do initial assessments predated the September survey by several months and that Petitioner should not be held accountable for what its staff failed to do in the remote past. I do not find this argument to be persuasive. The initial failure by Petitioner's staff to do assessments is an element of a pattern of failures by Petitioner's staff to provide needed services for the two residents whose care is at issue. Unlike the case of Resident # 3, which I discuss above, at Finding 2.c., the care that Petitioner gave to the two residents in question was ongoing. If Petitioner's only obligation to the two residents whose care is at issue here was to do an initial assessment for drug needs, I might be persuaded that its failures in the relatively remote past to do such assessments were not meaningful proof of the current state of care at Petitioner's facility. Here, however, Petitioner's failure to do an initial assessment was part of a continuum of failures by Petitioner's staff to monitor and assess the residents.

Petitioner argues that, in fact, it did assess the two residents on an ongoing basis for the need for continuing administration of psychotropic medications. It alleges that mental health notes show that Resident # 21 was monitored on a continuous basis. See P. Ex. 28. In fact, the exhibit that Petitioner relies on is a single mental health progress note dated May 21, 2002. It does not show continuous monitoring of the resident. The surveyors alleged that there was no evidence of monitoring in the resident's record after the implementation of a June 18, 2002 care plan which required such monitoring. I find that Petitioner has offered nothing to rebut this allegation.

Nor do I find evidence of monitoring of Resident # 7 for the possible adverse effects of psychotropic medication. Petitioner asserts that the resident was assessed on July 31, 2002 and on August 23, 2002 and that worksheets were generated which contained the results of these assessments. See P. Ex. 33, at 1 - 2. However, the worksheets that Petitioner relies on do not address the effects of medications. Id.

h. Petitioner complied substantially with the requirements of 42 C.F.R. § 483.30(b)(1) - (3).

At Tag 354 of the report of the September survey the surveyors allege that Petitioner failed to comply substantially with the requirements of 42 C.F.R. § 483.30(b)(1) - (3). CMS Ex. 21, at 17 - 19. In relevant part the regulation requires a facility to designate a registered nurse to serve as its director of nursing on a full time basis.

The surveyors alleged that Petitioner did not have a full time registered nurse director of nursing on its staff. They base this conclusion on two assertions:

• Allegedly, Petitioner did not have a director of nursing who was working a 40-hour week.

• The individual whom Petitioner designated as its director of nursing was not licensed to practice nursing in Tennessee.

Petitioner offered proof that, during the week that preceded the September survey, its director of nursing was Kerri Seibold, R.N. P. Ex. 42. Ms. Seibold is a registered nurse who is licensed to practice in the State of Tennessee. Id. Ms. Seibold works for Petitioner in a full-time capacity and regularly works more than 40 hours during the week. She averred that she was absent from Petitioner's facility on September 4 and 5, 2002 to attend a Coast Guard ceremony in Virginia at which her son was participating. Id. at 3. However, during the period of her absence another registered nurse was placed in charge on an acting basis. Id.

I find that the evidence offered by Petitioner fully rebuts CMS's allegations. The preponderance of the evidence establishes that Ms. Seibold was Petitioner's full-time, Tennessee licensed, registered nurse director of nursing.

There are no requirements in the regulation which require that a "full time" director of nursing work a 40-hour week or which preclude the director of nursing from taking days off. Clearly, an employee can be a "full time" employee and work less than 40 hours and take occasional time off. For this reason, I do not find to be persuasive the surveyors' assertions about Petitioner failing to have a director of nursing who worked a sufficient number of hours. The evidence is more than persuasive that Ms. Seibold functioned on a full time basis and that the hours she missed on September 4 and 5, 2002 were for personal reasons that are entirely consistent with full time employment.

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

At Tag 490 of the report of the September survey the surveyors alleged that Petitioner failed to comply substantially with the requirements of 42 C.F.R. § 483.75. CMS Ex. 21, at 19 - 22. This regulation provides that a facility must be administered in a manner that enables it to use its resources effectively and efficiently to attain or maintain the highest practicable physical, mental, and psychosocial well-being of each of its residents.

The surveyors based their allegations of noncompliance on two assertions. First, they argued that Petitioner's alleged failure to comply with the other eight tags that are cited in the survey report proved that Petitioner was not complying substantially with the requirements of the regulation. Second, they asserted that Petitioner did not allocate adequate staff to meet the needs of its residents.

I find that neither of these allegations are supported by prima facie evidence of noncompliance. The record of this case establishes that Petitioner failed to comply substantially with two participation requirements. The evidence of Petitioner's noncompliance is not, in and of itself, sufficient to establish an overall failure by Petitioner to comply with applicable administration requirements. CMS has offered nothing to show a nexus between Petitioner's noncompliance and the way in which it was administered.

Nor has CMS offered any prima facie proof to show that Petitioner assigned inadequate numbers of staff to meet the needs of its residents. The allegation that Petitioner's failures to provide care in accordance with applicable regulatory requirements are due to inadequate staffing by Petitioner is simply speculation in the absence of some concrete proof that Petitioner did not assign enough staff to meet its residents' needs.

3. A basis exists to terminate Petitioner's participation in Medicare.

As I discuss above, at Finding 1, CMS is authorized to terminate a facility's participation in Medicare based on the presence of even a single failure by that facility to comply with applicable participation requirements. The evidence in this case establishes that Petitioner failed to comply with two participation requirements. That is more than enough grounds for CMS to terminate Petitioner's participation in Medicare.

Steven T. Kessel
Administrative Law Judge