SUBJECT:

VITAS Healthcare Corporation of California,

Petitioner,

Health Care Financing Administration.

I. PROCEDURAL HISTORY

The hospice is located in Torrance, California. HCFA terminated the hospice's Medicare provider agreement, effective August 10, 1999. By letter and brief dated August 9, 1999, the hospice challenged the termination and requested an expedited hearing. The case was assigned to me for a hearing and a decision. I held an in-person hearing in Los Angeles, California from December 13 - 17, 1999, and from December 20 - 22, 1999.

At the hearing, I admitted exhibits from each party into evidence. From HCFA, I admitted into evidence exhibits which are identified as HCFA Ex. 1 - HCFA Ex. 4, HCFA Ex. 4A, HCFA Ex. 5 - HCFA Ex. 23, and HCFA Ex. 40 - HCFA Ex. 43. (I did not admit HCFA Ex. 24 - HCFA Ex. 39. I also did not admit HCFA Ex. 44 (Tr. 1480), and I did not take a copy of HCFA Ex. 44 for the record.) From the hospice, I admitted into evidence exhibits which are identified as P. Ex. 1 - P. Ex. 6, P. Ex. 7 (except for P. Ex. 7, p.7A, which I did not admit, Tr. 2142), P. Ex. 8 - P. Ex. 22, and P. Ex. 24 - P. Ex. 38. In this Decision, I refer to the transcript of the hearing as Tr.

HCFA completed its case-in-chief on the sixth day of the hearing, December 20, 1999. Tr. 1803. I limited HCFA's presentation to evidence relevant to the final survey in June 1999. After HCFA rested, the hospice moved to have the termination overturned, because HCFA had failed to demonstrate a prima facie case of violation of the regulations such that termination would be appropriate. Tr. 1803. I stated that I would take the hospice's motion under advisement. Tr. 1805.

The hospice resumed the presentation of its case-in-chief. (Over HCFA's objection, I had permitted the hospice to call three witnesses out of order during the midst of HCFA's presentation of its case-in-chief.) On December 22, 1999, over HCFA's objections (Tr. 2384 - 2385, 2387 - 2391, 2395 - 2396), I recessed the hearing so that I could consider the hospice's motion to overturn the termination, as well as its motion concerning whether HCFA had provided it with adequate notice of alleged deficiencies. I informed the parties that, in ruling on whether HCFA had established a prima facie case to support its termination, I would consider only the evidence presented in HCFA's case-in-chief; that is, the evidence that was elicited through HCFA's witnesses, including the cross-examination of them. I would not consider the testimony elicited through witnesses called by the hospice. Tr. 2386, 2396 - 2398, 2470. Thus, throughout this Decision, when I refer to the evidence, I am referring to only the evidence presented in HCFA's case-in-chief.

In February, March, and April 2000, the parties submitted briefs. In this Decision, I refer to the hospice's opening brief as P. Br. I refer to HCFA's brief as HCFA Br. I refer to the hospice's reply brief as P. R. Br. Each brief has attachments, which I do not admit into evidence. Neither party requested that any of its attachments be admitted into evidence; the attachments to the briefs have been accepted merely as part of the party's argument, and not as evidence.

The additional evidence that HCFA wished to present as part of its case-in-chief was from the March 1999 revisit survey. See Tr. 18. Both prior to the hearing and during the hearing, I informed the parties that I would not take any evidence pertaining to the March 1999 survey during the December 1999 hearing, but I reserved ruling as to whether I would receive the March 1999 survey evidence at a later time. Tr. 34 - 36. As I explain below in section V.D., I have concluded that the March 1999 survey evidence is irrelevant.

I now summarize the history of the 1999 surveys, followed by a summary of my rulings and order prior to this Decision.

The first of three surveys was completed on January 7, 1999, when surveyors from HCFA and the California Department of Health Services (State health agency) conducted a recertification/complaint survey of the hospice. The purpose of the survey was to determine whether the hospice was complying with the requirements of the Medicare program. The State health agency notified the hospice by letter that, based on the survey, it had determined that the hospice was out of compliance with 12 Medicare conditions of participation. The hospice was also provided with the HCFA Form 2567 -- Statement of Deficiencies (SOD), which listed all the alleged deficiencies found during the January 7, 1999 survey. The hospice was advised that it had the opportunity to take prompt corrective action. In response, the hospice submitted its credible allegation of correction.

To verify the hospice's representation that full corrective action had been taken, HCFA authorized an extended resurvey of the hospice. That resurvey was completed on March 4, 1999. As a result of that survey, HCFA notified the hospice by letter dated March 26, 1999 (HCFA Br., Attachment B), that it had determined that the hospice was out of compliance with six conditions of participation, and additionally, there were other deficiencies which remained uncorrected from the January 7, 1999 survey. HCFA advised the hospice that HCFA would terminate the hospice's participation in Medicare effective April 15, 1999. In response to the SOD which listed all the alleged deficiencies found during the March 4, 1999 survey, the hospice submitted its credible allegation of correction on May 25, 1999, alleging completion of correction by May 15, 1999 (HCFA Br., Attachment A).

Subsequent to HCFA's March 26, 1999 notice letter, HCFA made what HCFA characterizes as "a determination under the very unusual and uncommon circumstances" of the hospice's case (HCFA Ex. 2 at 2) to exercise its discretion not to effectuate the termination as noticed in its March 26, 1999 letter, pending a second resurvey of the hospice.

The second resurvey (3^rd survey) of the hospice was conducted by a survey team of two HCFA surveyors and two State health agency surveyors and was completed on June 23, 1999. The surveyors found that the hospice was out of compliance with two conditions of participation, Governing Body, 42 C.F.R. § 418.52, and Plan of Care, 42 C.F.R. § 418.58. By letter dated July 22, 1999, HCFA notified the hospice that, because it was not in compliance with all conditions of participation at 42 C.F.R. Part 418 as determined during the June 23, 1999 survey, HCFA would terminate the hospice's Medicare provider agreement effective August 10, 1999. HCFA Ex. 2 at 2. HCFA's notice letter stated further that the June 23, 1999 resurvey also documented that the hospice had failed to correct deficiencies identified during the prior March 4, 1999 survey, and that several of these deficiencies had also been identified during the January 7, 1999 survey. HCFA advised the hospice that these repeat deficiencies established a separate and distinct basis for termination under the terms of 42 C.F.R. §§ 488.28 and 489.53(a)(1). Id. at 2.

On January 18, 2000, I issued a ruling, entitled "Ruling on the Health Care Financing Administration's Request for Clarification, and Order Setting Briefing Schedule." Among other things, I reiterated that, in ruling on the hospice's above-mentioned motions (concerning overturning the termination, including the issue of adequate notice of alleged deficiencies), I would consider only the evidence presented by HCFA's witnesses during HCFA's case-in-chief, including both direct and cross-examination of HCFA's witnesses, plus all exhibits pertinent to direct and cross-examination of HCFA's witnesses. I also informed the parties that they were requested, but not required, to file briefs. I gave the parties briefing deadlines.

On January 31, 2000, I ruled on HCFA's Request for Reconsideration. In the Ruling, I stated, among other things, that I was declining to revise the deadlines contained in my January 18, 2000 Order. I also again overruled HCFA's renewed objections to my proceeding to rule on the issues of whether HCFA established a prima facie case, and whether HCFA provided the hospice with adequate notice.

By Order dated February 8, 2000, I granted HCFA's request for an extension of time to file its responsive brief, and extended the hospice's time to file its reply brief. I also requested the parties to identify one week in June or July 2000 to reconvene the hearing, should that prove necessary.

On June 5, 2000, I ruled, as follows:

HCFA's evidence failed to establish a prima facie case that the provider was out of compliance with either of the two conditions alleged by HCFA (Plan of Care, Governing Body). HCFA's evidence failed to establish a prima facie case that any deficiencies, individually or in combination, were of such character as to substantially limit the provider's capacity to furnish adequate care or adversely affected the health and safety of patients. Finally, HCFA's theory that repeat standard level deficiencies may constitute a separate basis for termination was not supported by HCFA's evidence in this case. HCFA's evidence regarding the alleged repeat deficiencies failed to establish a prima facie case that the health and safety of patients was jeopardized or that those alleged deficiencies were of such character as to seriously limit the provider's capacity to render adequate care.

Ruling That HCFA Failed to Establish a Prima Facie Case That It Had the Authority to Terminate, Effective August 10, 1999, Petitioner's Medicare Agreement, dated June 5, 2000.

My Ruling stated further that I was giving the provider the opportunity to decide whether it wished to present the remainder of its case-in-chief, in whole or in part, at the in-person evidentiary hearing that was scheduled to reconvene on June 12, 2000. My intention was to permit the provider to choose whether to present its remaining testimony at that time, before I issued a decision, or to wait, because further testimony might not be necessary.

I held a telephone conference with the parties on June 8, 2000. During the conference, counsel for the hospice requested that the hearing be continued until they had received a complete written ruling from me. The hospice's counsel also stated that it would like to submit a declaration, agreed upon by HCFA, stating that the hospice was reserving the right to present the remainder of its case-in-chief in the event my ruling, in whole or in part, is overturned by the Appellate Division of the Departmental Appeals Board (DAB) on appeal. HCFA counsel agreed to consider language to this effect submitted by counsel for the hospice, but questioned whether the hospice's attempt to reserve its right to present further evidence was legally binding, since it would be the Appellate Division who would have the authority to determine the further course of proceedings after issuing its decision on appeal. I informed the parties that I would permit the hospice to submit such a declaration, which would be entered into the record. Accordingly, I canceled the reconvening of the hearing.

The hospice was unable to obtain HCFA's agreement as to the language of the hospice's proposed declaration. As a result, the hospice, on its own, filed a Declaration dated June 14, 2000, regarding the reservation of its right to present the remainder of its case-in-chief in the event my ruling is overturned or modified, in whole or in part, by the Appellate Division of the DAB.

As discussed above, this Decision is based on only the evidence presented by HCFA's witnesses, including both direct and cross-examination of HCFA's witnesses, plus all exhibits pertinent to direct and cross-examination of HCFA's witnesses, without consideration of the evidence presented by the hospice's witnesses who did testify before I recessed the hearing. This Decision further details the Ruling I issued on June 5, 2000.

II. APPLICABLE LAW

This case involves a hospice. A hospice is a Medicare provider described under section 1861(dd)(1) of the Social Security Act (Act), which offers care, items, and services to a terminally ill individual. 42 U.S.C. § 1395x(dd)(1). Under the Medicare program, an individual is considered to be "terminally ill" if the individual has a medical prognosis that he or she is expected to live six months or less. Act, section 1861(dd)(3)(A); 42 U.S.C. § 1395x(dd)(3)(A).

The central purpose of hospice care is to provide dying individuals with palliative care, including the management of discomfort and symptom relief (42 C.F.R. § 418.58(c)), rather than curative care. A terminally ill individual has the option to choose hospice care as an alternative to traditional care.

Pursuant to section 1864(a) of the Act, the Secretary of the United States Department of Health and Human Services (Secretary), entered into agreements with State health agencies to survey hospices for compliance with Medicare conditions of participation and to report their findings to HCFA. HCFA acts as the delegate of the Secretary. 42 U.S.C. § 1395aa(a); 42 C.F.R. §§ 488.10 and 488.11. The Secretary may terminate a hospice's Medicare provider agreement after the Secretary finds that the hospice is not complying substantially with Medicare conditions of participation. Act, section 1866(b)(2); 42 U.S.C. § 1395cc(b)(2); 42 C.F.R. §§ 488.24, 488.26, 488.28, and 489.53(a)(1).

The conditions of participation for a hospice are found in the regulations at 42 C.F.R. §§ 418.50 - 418.100. HCFA is authorized to terminate a hospice's Medicare provider agreement where the hospice has failed to comply with a condition of participation. A hospice has failed to comply with a condition of participation where the deficiencies, either individually or in combination, are "of such character as to substantially limit the provider's . . . capacity to furnish adequate care or which adversely affect the health and safety of patients . . . ." 42 C.F.R. § 488.24(b). Likewise, HCFA determines that a hospice with deficiencies may continue to participate in Medicare only when the existing deficiencies, either individually or in combination, neither jeopardize the health and safety of patients nor are of such character as to seriously limit the hospice's capacity to render adequate care. 42 C.F.R. § 488.28.

In determining whether a hospice is compliant with a particular condition of participation, the surveyors evaluate the manner and degree to which the hospice satisfies the various standards within each condition. 42 C.F.R. §§ 418.50 - 418.100, and 488.26(b). A hospice standard-level deficiency is a failure to provide the care and services that meet the needs of the hospice patients as required by a hospice standard. 42 C.F.R. § 488.26.

HCFA bears the burden of coming forward with evidence sufficient to establish a prima facie case that a provider was not in substantial compliance with a condition of participation; or that the existing deficiencies, either individually or in combination, were "of such character as to substantially limit the provider's . . . capacity to furnish adequate care or which adversely affect the health and safety of patients . . . ." 42 C.F.R. § 488.24(b). See Hillman Rehabilitation Center, DAB No. 1611 (1997), aff'd, Hillman Rehabilitation Center v. United States Department of Health and Human Services, Health Care Financing Administration, No. 98-3789 (D.N.J. May 13, 1999).

• HCFA, in its discretion, permitted the hospice the opportunity to establish compliance with the Medicare conditions of participation by the time of the second resurvey (3^rd survey) which was completed on June 23, 1999. HCFA Ex. 2.
  

• HCFA failed to establish a prima facie case that, at the time covered by the June 1999 survey, the hospice was out of compliance with the Plan of Care hospice condition of participation. 42 C.F.R. §§ 418.58, 488.24(b), and 488.26(b). See Discussion below, section V.A.

• HCFA failed to establish a prima facie case that, at the time covered by the June 1999 survey, the hospice was out of compliance with the Governing Body hospice condition of participation. 42 C.F.R. §§ 418.52, 488.24(b), and 488.26(b). See Discussion below, section V.B.



• A hospice condition-level deficiency is a failure to satisfy one or more hospice standards, where the failure is of such character as to substantially limit the hospice's capacity to furnish adequate care or which adversely affects the health and safety of patients. 42 C.F.R. §§ 488.24(b) and 488.26.



• A hospice standard-level deficiency is a failure to provide the care and services that meet the needs of the hospice patients as required by a hospice standard. 42 C.F.R. § 488.26.

• HCFA failed to establish a prima facie case that, at the time covered by the June 1999 survey, any existing deficiencies, noted either individually or in combination, were of such character as to substantially limit the hospice's capacity to furnish adequate care or adversely affected the health and safety of patients. 42 C.F.R. §§ 488.24(b) and 488.26.

• HCFA was not authorized to terminate the hospice's Medicare provider agreement because: (a) the evidence failed to prove that, at the time covered by the June 1999 survey, the hospice failed to comply with any condition of participation (FFCL 2 & 3); and (b) the evidence failed to prove that, at the time covered by the June 1999 survey, the hospice had any deficiencies which, noted either individually or in combination, were of such character as to substantially limit the hospice's capacity to furnish adequate care or adversely affected the health and safety of patients (FFCL 6). 42 C.F.R. §§ 488.24(b) and 488.26.

• The only provision of 42 C.F.R. § 489.53 applicable here is subsection (a)(1), which provides that HCFA may terminate a Medicare provider agreement if the provider is not complying with the provisions of title XVIII and the applicable regulations of this chapter [42 C.F.R. Chapter IV], or with the provisions of the agreement. 42 C.F.R. § 489.53(a)(1).



• The circumstances under which HCFA may terminate a Medicare provider agreement are more specifically delineated in 42 C.F.R. §§ 488.24, 488.26, and 488.28, which, by being more specific, limit the broad, more general language of 42 C.F.R. § 489.53(a)(1).
  

• One or more repeat standard-level deficiencies could be substantial enough to constitute grounds to terminate a hospice's Medicare provider agreement, but only if the deficiencies, noted either individually or in combination, were of such character as to substantially limit the hospice's capacity to furnish adequate care or adversely affected the health and safety of patients. 42 C.F.R. §§ 488.24(b) and 488.26.



• HCFA failed to establish a prima facie case that the hospice had even a standard-level deficiency at the time of the June 1999 survey. 42 C.F.R. § 488.26. See Discussion below, section V.

• HCFA failed to establish a prima facie case that HCFA had the authority to terminate, effective August 10, 1999, the hospice's Medicare provider agreement. 42 U.S.C. § 1395cc(b)(2); 42 C.F.R. §§ 488.24, 488.26, 488.28, and 489.53(a)(1). See Discussion below, section V.D.



• HCFA did not have the authority to terminate the hospice's Medicare provider agreement.

V. DISCUSSION

A. Plan of Care. HCFA failed to establish a prima facie case that the hospice was out of compliance with the Plan of Care hospice condition of participation. 42 C.F.R. § 418.58.

The hospice's alleged noncompliance with the condition found at 42 C.F.R. § 418.58 (Tag L132)

HCFA alleged that in June 1999, the hospice had a condition-level deficiency in meeting the Plan of Care requirements (the hospice's alleged noncompliance with Tag L132). The Plan of Care requirements are found in the regulations at 42 C.F.R. § 418.58 (Condition of participation -- Plan of care).

42 C.F.R. § 418.58. Condition of participation - Plan of Care.

A written plan of care must be established and maintained for each individual admitted to a hospice program, and the care provided to an individual must be in accordance with the plan . . .

HCFA based the condition-level deficiency (Tag L132) on the hospice's alleged noncompliance with Tags L133, L135, L136, and L137.

The hospice's alleged noncompliance with the standard found at 42 C.F.R. § 418.58 (Tag L133)

In the SOD, under Tag L133, HCFA alleges the violation of 42 C.F.R. § 418.58 at the standard level, citing the regulatory language stated above. HCFA states that "[a] review of 9 of 9 clinical records revealed the identified plan of care was vague and non-specific. The identified goals for a problem had interventions that were not related to the goal." HCFA Ex. 1 at 8. Following these allegations is a recitation of the situations concerning six of the hospice's patients: Patients 7, 3, 2, 4, 8, and 9. Id. at 8 - 13.

Before discussing HCFA's alleged findings, I must first address the issue of whether HCFA provided the hospice with adequate notice in the SOD of its findings relating to this Tag. In its hearing request, and again in its initial post-hearing brief, the hospice asserted that while the SOD alleges that 9 clinical records had been found to be deficient, HCFA had set forth specific findings for only 6 patients, and had failed to provide the hospice sufficient notice in the SOD of the findings regarding the other three patients for it to respond adequately. For this reason, the hospice argued that I should not consider any findings concerning the three other patients' records.

I find that the hospice has raised a valid notice issue regarding the allegations under Tag L133. Although the surveyors stated in the SOD that nine clinical records, and therefore, nine patients, were reviewed under this particular Tag, the SOD then goes on to recite specific allegations relating to only six patients. HCFA could have identified the other three patients whose records were reviewed and provided the hospice with this information prior to the hearing. HCFA chose not to do so. Because it did not, I will consider only the allegations relating to the six patients that are set forth in the SOD in determining whether they support a finding that the standard at 42 C.F.R. § 418.58 was not met.⁽¹⁾

SOD Finding 1(a) under Tag L133 - Patient 7

With respect to Patien 7, in the SOD, HCFA contends that the hospice nurse failed to document that she monitored Patient 7's bowel pattern and rectal burning at every visit as required by the patient's Care Plan #3 for Elimination. HCFA Ex. 1 at 9 - 10.

I am persuaded that the documentation with respect to the monitoring of Patient 7's bowel pattern was not adequate in all respects. However, as I will discuss below, this inadequacy in documentation does not support a finding of noncompliance with the standard. With respect to HCFA's allegation concerning monitoring of Patient 7's rectal burning, I find that the hospice's documentation was adequate.

Patient 7 had a diagnosis of amyotrophic lateral sclerosis (ALS), commonly known as Lou Gehrig's disease. Patient 7 received hospice care at her home. According to the medical record, Patient 7's primary caregiver appears to have been a family member. HCFA Ex. 11 at 1. The State health agency surveyor, Ms. Garces, testified that she visited Patient 7 at her home and interviewed her in the presence of one of the hospice nurses who was there providing care to the patient. Tr. 397 - 398.

Patient 7's Care Plan #3 for Elimination contained interventions to monitor the patient's bowel pattern at every visit and to monitor for rectal burning at every visit. HCFA Ex. 11 at 14. The intervention to monitor Patient 7's bowel pattern was written in conjunction with the hospice team goal that the "Pt. [patient] will have BMs [bowel movements] Q [every] 3 days." Id. at 14. The intervention to monitor Patient 7's rectal burning was written in conjunction with the team goal that the "Pt. will receive Anusol & Prep H per doctors orders to relieve rectal burning." Id.

As evidence that the nurse was monitoring Patient 7's bowel pattern at each visit, the hospice points to the nursing notes dated May 19, 1999, May 27, 1999, June 2, 1999, June 9, 1999, and June 16, 1999, and states that for each of these dates, the nurse wrote "BM's [bowel movements] per poc [plan of care]." HCFA Ex. 11 at 53, 49, 45, 40, and 35; P. Br. at 98.⁽²⁾ The hospice asserts that the surveyor conceded that this phrase ("BM's per poc") indicates that Patient 7 had bowel movements every three days, which would be in accordance with the care plan. P. Br. at 98; Tr. 423. The hospice contends that the surveyor admitted that there is documented evidence that the nurse was monitoring or assessing the patient's progress toward the goal on the care plan. Tr. 434 - 435. The hospice argues also that each of the nursing notes also contains the date of Patient 7's last bowel movement, which is further indication that the patient was meeting the hospice team goal of having bowel movements every three days. Id. Furthermore, the hospice argues that, according to the nurse's notes, Patient 7 was not experiencing any constipation, diarrhea, or impaction, since the nurse had not checked off those areas in the notes. Id.

Ms. Garces testified that the fact that neither the care plan nor the nursing notes identified any bowel movement pattern indicated that monitoring was not occurring. Tr. 408, 444; HCFA Ex. 11 at 35. Ms. Garces stated that, as part of monitoring, the nurse should have defined what constituted a regular bowel movement for the patient. Tr. 457. With respect to the nurse's notes, Ms. Garces stated that the notes did not indicate "how many days apart" the patient's bowel movements were and that "[t]here's no way of knowing what type of bowel movements [Patient 7] was having, whether she was having diarrhea stools, whether she was having hard bowel." Tr. 443, 433. Moreover, Ms. Garces testified also that, while the goal was for Patient 7 to have bowel movements every three days, nowhere in the nursing notes is it documented that the goal of having bowel movements every three days was met. Tr. 444.⁽³⁾

While I do not agree with Ms. Garces' contention that monitoring was not occurring (the notations that were made suggest that monitoring of Patient 7's bowel movements was occurring), I do find that additional, specific charting with respect to Patient 7's bowel pattern would have been helpful. I recognize that the nurse was not a witness to the patient's bowel movements; she visited only once a week and relied on the information she got from the patient and family members. I find that, presumably, when the nurse wrote, "BM's [bowel movements] per poc [plan of care]," she meant that she had been told that Patient 7's bowel movements were occurring every three days, in accordance with the goal. But one should not have to presume what the nursing notation means. Saying that care is being provided "per plan of care," gives no clear indication what care was provided and leaves a dearth of information, both for other caregivers, and for surveyors.

Despite the nurse's failure to record literally the frequency of Patient 7's bowel movements, the date of the patient's last bowel movement is recorded each visit. On May 19, 1999, Patient 7's last bowel movement was shown to have been on May 17. On May 27, 1999, her last bowel movement was shown to have been on May 26. On June 2, 1999, Patient 7's last bowel movement was shown to have been on June 1. On June 9, 1999, her last bowel movement was shown to have been on June 9. On June 16, 1999, Patient 7's last bowel movement was shown to have been on June 16. HCFA Ex. 11 at 53, 49, 45, 40, and 35. Thus, the documentation shows that Patient 7 had a bowel movement on the same day as the nurse's visit, or within one or two days of the visit. The documentation fails to show that Patient 7's bowel movements were occurring at least every three days.

There is no dispute that Patient 7 had a care plan for elimination. The nursing notes do contain notations or comments concerning Patient 7's bowel movements, including the date of her last bowel movement. What I find to be inadequate about the documentation is that "per plan of care" is unclear, and that too little information is provided. Here, the care to be provided was the monitoring, so that it would be clear if interventions were needed to help the patient meet her goal.

I would have liked the nursing notes to have contained more specific documentation, e.g., a literal statement of the frequency of Patient 7's bowel movements, and a description of what kind of bowel movements she was having. Nevertheless, I find no deficiency under Tag L133 regarding Patient 7's Elimination plan of care, because the omission of detail was relatively insignificant and because there was no evidence to show that the care provided to Patient 7 was not in accordance with her plan of care, as required by the regulation, or that the care failed to meet her needs. Thus, I do not find the documentation inadequacy so significant as to support a finding that the hospice failed to comply with the standard under Tag L133.

With respect to HCFA's allegation that the hospice did not monitor Patient 7's rectal burning at every visit, I do not agree and find that the hospice's documentation was adequate. The nurse's notes, as well as the surveyor's testimony, demonstrate to my satisfaction that Patient 7's rectal burning was being monitored in accordance with the care plan directive.

In the nurse's notes, which are the focus of this allegation, the nurse documented that Patient 7 was using the medications Prep H and Anusol and wrote "effective for rectal burning."⁽⁴⁾ HCFA Ex. 11 at 35, 40, 45, 49, and 53.

Although Ms. Garces testified that the hospice's nursing notes should have stated additional information regarding Patient 7's rectal burning, such as "the degree of rectal burning or if [the patient] was experiencing more" (Tr. 418, see Tr. 446), I do not agree that more documentation was necessary in order to demonstrate that the hospice was monitoring the patient's rectal burning. The fact that each of the nurse's notes states the medications being used, and contains the notation "effective for rectal burning" is adequate to show that the hospice monitored the effectiveness of the medications at each visit, and thus, was also monitoring Patient 7's rectal burning. On cross-examination, Ms. Garces acknowledged that it did appear that the nurse was documenting in the nurses' notes "that the patient's rectal burning was being relieved by those medications." Tr. 415. Ms. Garces conceded further that it "appear[ed]" that the "nurse was on each visit assessing whether or not the patient's rectal burning was being relieved." Tr. 415; see Tr. 417. Ms. Garces admitted also that the patient did not complain that the medication was ineffective and conceded that, according to the documentation, the patient's symptom of rectal burning was controlled. Tr. 422; see Tr. 414.

The goals in Patient 7's Elimination plan of care were that she have a bowel movement every three days and that her rectal burning be relieved. The evidence fails to prove that Patient 7 was not provided with care and services in accordance with her Elimination plan of care. Despite the lack of specificity in describing Patient 7's bowel movements, there is no evidence that the hospice failed to monitor Patient 7's bowel pattern every visit or failed to monitor for rectal burning every visit. Based on the evidence regarding Patient 7, there is no standard-level deficiency under Tag L133.

S.O.D. Finding 1(b) under Tag L133 - Patient 3

At the hearing and in its post-hearing response brief, HCFA admitted that the reference to Patient 3 in Finding 1(b) on p. 10 of the SOD (HCFA Ex. 1 at 10) was a typographical error, and that Patient 7, rather than Patient 3, should have been referenced. Tr. 460; HCFA Br. at 62.

The hospice objected to any discussion of this alleged deficiency on the grounds that it had not been given adequate notice by HCFA as to whom this alleged deficiency was referring. The hospice asserted that its request for hearing put HCFA on notice that it had not received accurate notice of which patient was at issue here, but, despite being made aware of this notice issue, HCFA never corrected or clarified the typographical error. Tr. 461, 465 - 466; P. Br. at 99.

HCFA did not deny that it had failed to provide the hospice with any written notification to correct or clarify the typographical error. HCFA argued, however, that the hospice should have raised this concern in its meetings with HCFA, and also that it should have been obvious from the format of the SOD that it was Patient 7, not Patient 3, who was at issue. Tr. 461 - 465.

I stated at the hearing that I "d[id] not find the format of the 2567 [SOD] to be so obvious that it gives notice to [the hospice] that the reference to Patient No. 3 meant Patient No. 7." Tr. 466. I ruled that I would not "allow evidence as to this particular patient on this particular tag." Tr. 468.

In its brief, HCFA requests that I reconsider my ruling denying consideration of this alleged deficiency, contending that the remainder of the allegation in the SOD correctly identifies the patient as Patient 7. HCFA argues that "it should have been obvious to [P]etitioner" that Patient 7 was the patient being referenced. HCFA Br. at 62 - 63.

In my decision in the Libbie Convalescent Center case, DAB CR589 (1999), I discussed the issue of HCFA's failure to notify the hospice, in writing, of a numbering error on the resident list.⁽⁵⁾ I held that:

[t]he burden of providing adequate notice must be placed on HCFA. A provider should not be put in the position of second guessing the statement of deficiencies as to resident identities. When HCFA realized its mistake, it was incumbent on it to notify Petitioner, in writing, of this essential information. Informing Petitioner, orally, [at the Informal Dispute Resolution proceedings] where it cannot be represented by counsel, is not sufficient notice. When such information is conveyed orally, there is a serious risk of misunderstanding, error, or miscommunication, as appears to have happened as regards residents N.R. and N.W.

Libbie Convalescent Center, at 11.

My holding in Libbie applies to the case at hand. HCFA had the obligation to provide the hospice with written notification that there was a typographical error as to a resident identity in the SOD, and that Patient 7, rather than Patient 3, should have been referenced on p. 10 of the SOD. HCFA failed to provide the hospice with any written correction or clarification. Accordingly, I conclude that HCFA did not provide the hospice with adequate notice as to this alleged deficiency under Tag L133, and I consequently eliminate this alleged deficiency from consideration.

Here, in the SOD, Patient 3 is mistakenly cited as the example, followed by a reference to Patient 7, who is the intended example. The allegations here, under Tag L133, concern certain medications that were not available in Patient 7's home, and those same allegations are thoroughly evaluated on the merits under Tag L213. See infra the discussion of Patient 7 under Tag L213. Under Tag L213, on page 30 of the SOD (HCFA Ex. 1 at 30), Patient 6 is mistakenly cited as the example in the SOD, followed by a reference to Patient 7, who is the intended example. With respect to Tag L213, I found that HCFA had provided adequate notice of the patient's identity, and that the error in the SOD was overcome by the detail contained in the same section of the SOD, where there were two references to Patient 7. Tr. 1770; HCFA Ex. 1 at 30 - 31.

SOD Finding 2 under Tag L133

Under Finding 2 of Tag L133 in the SOD, HCFA alleged, in part, that "the problem list" in the Plan of Care Case Conference Summary form in "nine patient records" "did not correlate with the standardized problems on the Interdisciplinary Care Plan Problem forms" and that "[t]his method of care planning resulted in interventions being noted for problems for which they were not appropriate." HCFA Ex. 1 at 10 - 11. HCFA mentioned two examples under this finding, but did not cite any specific patients or any specific patient records.

At the hearing, HCFA did not offer any evidence in support of these allegations. HCFA also did not make any arguments in its posthearing brief concerning this alleged deficiency.

The hospice asserts that because HCFA failed to present any evidence at the hearing relating to these allegations, this alleged deficiency must be dismissed. P. Br. at 99 - 100.

I conclude that HCFA failed to come forward with any affirmative proof in support of the allegations under Finding 2 of Tag L133 in the SOD. Although HCFA contends in the SOD that care plan documentation problems were identified in "nine patient records," it failed to identify any of those nine patients or records on which the surveyors relied as evidence for their findings of noncompliance. The fact that HCFA's allegations suffer from a lack of specificity constitutes a lack of notice to the hospice. The hospice had no way of knowing what evidence to offer to rebut HCFA's allegations. HCFA's unsubstantiated allegations and lapse in proof mean there is no basis on which to find the presence of any deficient behavior on the part of the hospice with respect to its care-planning documentation.

SOD Finding 3 under Tag L133 - Patient 2

In he case of Patient 2, HCFA contends in the SOD that there was no documented evidence as to how the interventions of discontinuing monthly laboratory work and providing Lopressor according to the physician's orders related to the patient's comfort management. HCFA Ex. 1 at 11. Additionally, HCFA stated that, according to the Food and Fluid care plan, the hospice team goal for Patient 2 was "maintain source of nutrition through end of life." HCFA noted that the patient received a gastrointestinal tube feeding of Isosource HN. HCFA alleges that there was no documented evidence as to how the interventions of checking blood sugar daily, with regular insulin coverage, and using Compazine to treat nausea and vomiting, related to Patient 2's maintaining a source of nutrition. Id. at 12.

In attempting to prove this alleged deficiency, HCFA relies to a large extent on the testimony of its surveyor, Commander (Cdr.) Liebmann. Cdr. Liebmann is a registered dietician. The weight I give to Cdr. Liebmann's testimony depends in large measure on the degree of expertise she possesses concerning the subject area of her testimony, and on the extent to which her statements are supported by the documentary evidence. However, I give little weight to her opinion as to the propriety of care ordered by physicians.

HCFA does not dispute that care plans were established and maintained for Patient 2, who resided in a nursing home.⁽⁶⁾ See HCFA Ex. 6 at 1. Rather, HCFA appears to question the rationale behind various interventions and their relation to a particular care plan.

With respect to the interventions listed for Patient 2's comfort management, HCFA's surveyor questioned how these interventions would further the patient's comfort. For the reasons stated below, I find HCFA's arguments that the discontinuation of laboratory work and using Lopressor would not have addressed or furthered the comfort management of Patient 2 to be flawed.⁽⁷⁾ HCFA argues that "there is no evidence showing why the instructions to discontinue monthly lab work and to administer Lopressor should even have been included in a plan of care for managing the patient's comfort." HCFA Br. at 65; See Tr. 472 - 473. However, contrary to HCFA's contention, the listing of these interventions on Patient 2's Comfort care plan were directly related to Patient 2's comfort. Because laboratory testing often entails pricking the patient's skin with a needle, which could be painful, the discontinuation of laboratory work would contribute to a patient's comfort. Indeed, on cross-examination, the surveyor conceded that "it's possible" that the discontinuation of lab work and the attendant needle-pricking would contribute to the patient's comfort. Tr. 482. With respect to Lopressor, the surveyor testified on cross-examination that it would be important to a patient's comfort for a patient to keep his blood pressure under control (Tr. 500), and admitted there was no potential for harm to Patient 2 from the hospice documenting on its Comfort care plan that the patient was on Lopressor. Tr. 501. Thus, I find also that the use of Lopressor for Patient 2 was an appropriate and relevant intervention.

I conclude also that HCFA's allegation concerning the Food and Fluid care plan interventions for Patient 2 is without basis. I reject HCFA's argument that the intervention of checking Patient 2's blood sugar daily, with regular insulin coverage, would not be pertinent to the goal of maintaining the patient's source of nutrition. Patient 2's medical conditions included diabetes, for which she was on insulin. Tr. 471 - 473. Although Patient 2's diabetes was not related to her terminal illness (Tr. 476), there is nothing improper to be inferred from the hospice's monitoring and treating her diabetes. Indeed, the surveyor admitted on cross-examination that "there is some relationship between the patient's diabetes and maintaining nutrition." Tr. 485. The surveyor testified further on cross-examination that "blood sugar and insulin affect how a patient would maintain a source of nutrition." Tr. 488. Thus, it is reasonable to conclude that the intervention of checking Patient 2's blood sugar daily is directly related to Patient 2's maintaining a source of nutrition.

In the SOD, HCFA also appears to question the intervention in the care plan for Isosource formula. When asked to state the basis for citing this as part of the alleged deficiency, the surveyor testified that "It [i.e., the care plan] just states an order. It's not necessarily an intervention how that's going to maintain nutrition through life, through end of life." Tr. 476; HCFA Br. at 67. The surveyor testified that Patient 2's care plan (HCFA Ex. 6 at 9) was inadequate "to address the tube feeding." Tr. 477 - 478. The surveyor stated that she would have expected the care plan to document such things as whether the patient was tolerating the tube feeding, whether there were any complications from the tube feeding, whether the patient was receiving sufficient calories, whether her weight was stable, and whether there were any side effects from the tube feeding. Tr. 477. I am not persuaded that the intervention for Isosource inadequately addresses or relates to the hospice team goal of maintaining a source of nutrition for Patient 2. In fact, Patient 2's medication list states that Isosource HN liquid was being given for her nutritional abnormalities. HCFA Ex. 6 at 20. Moreover, I note that, in the SOD, HCFA does not explicitly allege that the order for Isosource was problematic -- the SOD states only that Patient 2 "received a gastrointestinal tube feeding of Isosource HN, administered at 55 ml/hr for 22 hours." HCFA Ex 1 at 12.⁽⁸⁾ In any case, common sense would indicate that giving the patient tube feedings and having a care plan intervention for Isosource, which is the tube feeding formula, would directly relate to the maintenance of a source of nutrition for Patient 2. There was no evidence to convince me otherwise.

Moreover, whether or not Patient 2 was absorbing her Isosource feedings would depend on whether her nausea and vomiting was controlled. Thus, it is reasonable to conclude that controlling Patient 2's nausea and vomiting with Compazine would be a relevant intervention to the goal of maintaining a source of nutrition for the patient. I find that it was not a deficient practice on the part of the hospice to administer Compazine to the patient. In fact, at the hearing, the surveyor conceded that the use of Compazine was an "appropriate" intervention since "nausea and vomiting can be a result of the tube feeding," and stated further that there is "no deficiency regarding the Compazine." Tr. 478, 490 - 491.

I conclude that the evidence, evaluated in accordance with 42 C.F.R. § 488.26, does not support a finding that the standard under Tag L133 was not satisfied with regard to Patient 2. There is no evidence to prove that the care provided to Patient 2 by the hospice was inadequate or that the hospice failed to meet the needs of Patient 2 in accordance with the applicable portion of 42 C.F.R. § 418.58.

SOD Finding 4 under Tag L133 - Patient 4

In the case of Patient 4, HCFA alleges that there was no documented evidence how the medication Risperdal was related to the management of the patient's emotional grief and anxiety. HCFA Ex. 1 at 12.⁽⁹⁾

For the reasons stated in the hospice's brief, I do not find that the standard under Tag L133 was not satisfied with regard to Patient 4.

Patient 4 resided in a skilled nursing facility. See HCFA Ex. 8 at 1. There is no dispute that an interdisciplinary plan of care, labeled "#4 - Emotional Reaction," was established for Patient 4 to address her emotional needs. HCFA Ex. 8 at 69. According to the care plan updates, the hospice interdisciplinary team approved the use of Risperdal to treat Patient 4's "anxiety m/b [manifested by] kicking." Id. at 6. The intervention to administer Risperdal was initiated on April 20, 1999, and the interdisciplinary team changed the dosage around May 28, 1999. Id. The hospice team goals are stated in the April 20, 1999 care plan updates as follows: "Pt. [patient] will remain calm [with decreased] episodes of anxiety" and "[the hospice] will be aware of changes in pt. mental state." Id.

Cdr. Liebmann testified that Patient 4 is nonverbal, and offered testimony that it was "hard for [her] to understand" how the hospice was able to assess the patient's anticipatory grief or anxiety (Tr. 520; see Tr. 522) and that the hospice should have assessed "what was causing the anxiety." Tr. 543. Cdr. Liebmann testified that she was unable to "see the relationship" between Risperdal and anticipatory grief and anxiety. Tr. 520 - 521. She asserted that a deficiency existed "because there's no clear indication as to the intervention being appropriate to meeting the goals of the emotional reaction, anticipatory grief or anxiety." Tr. 528 - 529.

HCFA argues also that the care plan does not indicate how the effectiveness of Risperdal in relieving the patient's grief and anxiety would be determined. HCFA Br. at 69. HCFA contends further that Patient 4 could be kicking for reasons other than being anxious, and points to other information in Patient 4's medical record which indicates her kicking could be related to a history of leg pain. Id.; see HCFA Ex. 8 at 68. According to Cdr. Liebmann, Patient 4's medical record does not allow one to determine whether the patient's "kicking and moaning were from pain as opposed to being related to anxiety." Tr. 538. HCFA thus asserts that Risperdal might not be an appropriate intervention for the patient's kicking. HCFA Br. at 69; see Tr. 523. Although HCFA acknowledges that the record shows that Patient 4 was experiencing agitation as manifested by constant kicking and moaning (HCFA Ex. 8 at 23), HCFA nevertheless asserts that "since there was never a good assessment as to why the patient was moaning and kicking, it was an inappropriate intervention to simply order Risperdal without knowing the root cause of any of these symptoms." HCFA Br. at 69; see Tr. 525.

I am not convinced by HCFA's arguments. Patient 4's care plan clearly states that the Risperdal, an anti-psychotic medication, is to be used to treat her anxiety as manifested by kicking. I find there is nothing improper to be inferred from this. In fact, Cdr. Liebmann testified that Risperdal could "possibly" be given for anxiety. Tr. 521 - 522. The fact that Patient 4 is a nonverbal patient who could not have expressed anxiety verbally does not lead to a different conclusion. Cdr. Liebmann testified that, in a nonverbal patient, some of the expressions of anxiety would be restlessness and agitation. Tr. 522, 529. As stated above, Patient 4's medical record shows that she was agitated, and that Risperdal was prescribed for her "agitation m/b [manifested by] constant kicking/moaning. Tr. 522; HCFA Ex. 8 at 23. On cross-examination, Cdr. Liebmann conceded that it was "possible" that Patient 4's agitation could mean that she was experiencing anxiety. Tr. 529 - 530. Cdr. Liebmann admitted that kicking could "[p]ossibly" be a symptom of anxiety in a nonverbal patient. Tr. 532. Thus, although Patient 4 is nonverbal, it is certainly possible that she was experiencing anxiety as manifested by her agitation, thus making the administration of Risperdal an appropriate intervention.

Moreover, I am not persuaded by HCFA's argument that because the hospice did not determine the "root cause" of Patient 4's moaning and kicking, it was inappropriate to order Risperdal for the patient. By this argument, HCFA is essentially questioning the propriety of care ordered or provided by the interdisciplinary team to Patient 4. The only testimony offered by HCFA on this issue was that of Cdr. Liebmann, who is a registered dietician, and not a physician. I do not find Cdr. Liebmann to be qualified to opine as to the propriety of care given to Patient 4. It is manifest from Patient 4's medical record that the interdisciplinary team identified that Patient 4 was experiencing anxiety and sought to decrease her anxiety with Risperdal. Thus, absent any medical expert testimony to the contrary, of which none was presented by HCFA, there is nothing to suggest that the hospice's treatment of Patient 4 with Risperdal was improper or unrelated to her anxiety.

Finally, I note that although the SOD alleged that "[t]here was no documented evidence how [Risperdal] was related to the management of emotional grief and anxiety" (HCFA Ex. 1 at 13), on cross-examination, Cdr. Liebmann admitted that Patient 4's care plan did not state that Risperdal was to be used to treat her emotional grief. Tr. 535 - 536.

The evidence fails to show that Patient 4 was not provided with care in accordance with her interdisciplinary care plan for Emotional Reaction. Based on the evidence regarding Patient 4, there is no standard-level deficiency under Tag L133.

SOD Finding 5 under Tag L133 - Patient 8

With respect to Patient 8, HCFA alleges in the SOD that a review of the nurses' notes from May 18, 1999 to June 15, 1999, revealed that the hospice did not have documentation for three of five visits to indicate that the skilled nurse had monitored the patient's breath sounds at every visit as stated in the plan of care. HCFA Ex. 1 at 12 - 13.

Patient 8 received hospice care at home. HCFA Ex. 12 at 1. Patient 8's interdisciplinary care plan for Ventilation contains, among other interventions, a directive dated October 8, 1998, to "monitor breathe [sic] sounds Q [every] visit." Id. at 41. The interdisciplinary team goal written in conjunction with the aforementioned directive stated that the patient was "to receive DME [durable medical equipment] and medications to relieve dyspnea." Id.

Based on the testimony of the State health agency surveyor, Ms. Poolsawat, the five nurse visits referenced in the SOD were those performed on May 18, 1999, May 25, 1999, June 4, 1999, June 8, 1999, and June 15, 1999. Tr. 561 - 565, 629 - 672, 678 - 681, 695 - 696, 697 - 705, 710 - 715, 729 - 733. Of these five visits, Ms. Poolsawat testified that the nursing notes for the visits made on May 25, 1999, June 4, 1999, and June 15, 1999, did not contain documentation that the nurse had monitored Patient 8's breath sounds on these visits. Tr. 666.

The nursing notes for May 25, 1999, indicate in the "Respiratory" section that Patient 8 has rales and wheezes, and is taking oxygen as needed. The nurse also wrote a zero to document that Patient 8 did not have a cough. In the "comments" section, the nurse wrote the following: "Pt. Denies S.O.B. [shortness of breath] - Pt. uses O2 [oxygen] regularly PRN [as needed] - 0 cough since taking cough syrup - compliant with inhalers." HCFA Ex. 12 at 24. Based on these notations and comments, I am satisfied that the hospice nurse adequately monitored Patient 8's breath sounds on this visit. It would not have been possible for the nurse to determine that Patient 8 had rales and wheezes unless she had listened to Patient 8's lung sounds. This was not disputed by Ms. Poolsawat. Tr. 667. Moreover, the zero which the nurse wrote next to the word "cough" adequately indicates that Patient 8 was assessed not to have a cough.

In the June 4, 1999 nursing notes, the nurse documented in the "Respiratory" section that Patient 8 has rales, has a cough "in a.m. only," and is taking oxygen as needed. The "comments" section states: "Pt. Denies S.O.B. - Rales noted scattered throughout lungs fields." HCFA Ex. 12 at 16. As with the May 25, 1999 nursing notes, I find that these notations and comments constitute sufficient evidence to demonstrate that the hospice nurse listened to Patient 8's lungs on this visit and, thereby, carried out the care plan directive to monitor the patient's breath sounds. It would not be reasonable to conclude otherwise based on the nurse's comments that she noted rales scattered throughout Patient 8's lungs and that he coughed only in the mornings. Ms. Poolsawat admitted that these notes indicate that the nurse listened to Patient 8's breath sounds. Tr. 695.

Thus, I am not persuaded that the nursing notes for the May 25 and June 4, 1999 visits contained inadequate documentation regarding the monitoring of Patient 8's breath sounds. Below, I discuss the documentation from the remaining visit, on June 15, 1999. HCFA Ex. 12 at 9.

The hospice nurse left the boxes for rales and wheezes unchecked in her notes for June 15, 1999. HCFA Ex. 12 at 9. Leaving the boxes unchecked might indicate an absence of rales and wheezes. But the hospice nurse also failed to make any notations to affirmatively indicate that Patient 8 did not have these symptoms. The nurse affirmatively indicated that Patient 8 did not have a cough by writing a zero next to the word "cough." Id. It is thus unclear to me whether the nurse monitored the patient's breath sounds for rales and wheezes on June 15, 1999. If the nurse monitored Patient 8's breath sounds that day, in accordance with Patient 8's care plan, and found no rales or wheezes, she could have documented that by writing zeros next to the words "rales" and "wheezes." This charting, therefore, contains an omission.

The hospice explains the charting omission with respect to rales and wheezes by stating that its staff follows a method of charting known as "charting by exception."⁽¹⁰⁾ According to the hospice, under this method, a nurse would only write down abnormal findings, and would not be required to write down normal findings. Tr. 672, 675 - 676. Thus, the hospice argues, the fact that nothing was written next to rales and wheezes in the nursing notes means that the patient was not having any problems with his breath sounds. P. Br. at 111.

The hospice's explanation of "charting by exception" does not change my analysis. As stated above, I find that the documentation in the June 15, 1999 nursing notes is lacking with respect to the monitoring of Patient 8's breath sounds. It is evident from the May 25, 1999 and June 4, 1999 nursing notes that Patient 8 had rales and wheezes. If Patient 8 no longer had rales and/or wheezes on June 15, 1999, then the hospice nurse should have affirmatively stated this in the nursing notes.

In considering whether the hospice's inadequate documentation on one day supports a finding of noncompliance with the standard under Tag L133, I find the hospice's omission to be insignificant in the context of the care provided to Patient 8. On cross-examination, Ms. Poolsawat testified that she had no evidence of harm to Patient 8 as a result of the alleged deficiency. Tr. 728. The June 15, 1999 nursing notes are one of five nursing notes in Patient 8's medical record reviewed regarding breath sounds. Those five nursing notes provide evidence that the hospice did provide care and services to Patient 8 that met his needs in accordance with his plan of care. A single question remains, and that is whether the hospice nurse, on June 15, 1999, monitored Patient 8's breath sounds for rales and wheezes.

In the June 15, 1999 nursing notes, the hospice nurse had indicated that Patient 8's goal for that visit was, "No goal -- I'm doing good." HCFA Ex. 12 at 9. What the hospice nurse indicated in the respiratory section of the notes was that no new or further intervention was required, referring to care plan #11. As previously stated, she indicated also that he had no cough. The hospice nurse wrote that "Pt. Denies Dyspnea currently - uses O2 [oxygen] approx. 3x per day." She made a further notation regarding the rate and method of delivery of his oxygen. The hospice nurse left the boxes for rales and wheezes unchecked. Id.

This inadequate charting for only one day for only one aspect of Patient 8's respiratory monitoring is insufficient for HCFA to establish a prima facie case that the hospice failed to provide care to Patient 8 in accordance with his plan of care. As discussed above, out of the three nurse visits alleged by Ms. Poolsawat to have inadequate documentation, I found the nursing notes for two of those three visits (May 25, 1999 and June 4, 1999) to be adequate. There was no evidence that the hospice failed to provide care that met Patient 8's needs in accordance with his interdisciplinary care plan for Ventilation. This insignificant documentation omission in the June 15, 1999 nursing notes certainly does not rise to even a standard-level deficiency under Tag L133.

SOD Finding 6 under Tag L133 - Patient 9

With respect to Patient 9, the SOD alleges that, although a "home health aide documented that the patient developed reddened areas on the coccyx and perineal area"⁽¹¹⁾ and notified the registered nurse of this finding, a review of the nurses' notes revealed that there was no documentation "to reflect that the registered nurse had assessed the patient's skin on [the] coccyx and perineal" areas. The SOD goes on to contend that a care plan was not developed for the aforementioned finding. HCFA Ex. 1 at 13.

The surveyor, Ms. Poolsawat, visited Patient 9 at her home. Ms. Poolsawat described the patient as being bedridden, with her husband as the primary caregiver. Tr. 745. Patient 9 had a gastrostomy (feeding) tube. Id. Ms. Poolsawat testified that she reviewed a Home Health Aide Note dated June 14, 1999. Tr. 746. On this note, in the "comments" section, the home health aide had documented, among other things, that the patient's skin was "warm to the touch" and that there was a "reddened area on coccyx." The home health aide had also written that she had notified the registered nurse of these findings. HCFA Ex. 13 at 92.

Ms. Poolsawat testified further that she reviewed the June 14, 1999 nursing notes, and that the "skin" section of the nursing notes stated only that the patient's percutaneous endoscopic gastrostomy (PEG) dressing was to be changed daily, and that her skin was "pink and moist in color." Moreover, the nurse had indicated that no new or further interventions were required. Tr. 747 - 748; HCFA Ex. 13 at 94. Ms. Poolsawat stated that the nursing notes did not contain any description at all of the patient's skin around the coccyx area. Tr. 750. According to Ms. Poolsawat, the comment that the patient's skin was "pink and moist" appears to indicate that the nurse examined the PEG area and found only the skin around that area to be pink and moist. Id. Ms. Poolsawat found no evidence that the nurse had examined the patient's coccyx area or that a care plan was developed for the reddened area. Tr. 745 - 746, 748. On cross-examination, Ms. Poolsawat stated that if the nurse had written "no reddened area on coccyx," she would not have found a documentation problem. Tr. 790.

Since the perineal area is not at issue (see 24 n.11), HCFA's allegations concern only the coccyx (tail bone) area. HCFA alleges that a reddened area on Patient 9's coccyx, discovered by a home health aide (HCFA Ex. 13 at 92), was not properly addressed by the hospice. I find that the home health aide noted the reddened area on the coccyx on June 14, 1999, at about 2:40 p.m. Id. Within an hour-and-a-half, on June 14, 1999, at about 4:00 p.m., the hospice nurse assessed Patient 9, including her skin. Id. at 93, 94. The nurse's documentation regarding Patient 9's skin for the June 14, 1999 visit states, "Peg drsg [dressing] [change] daily. Skin pink & moist in color [sic]." The nurse also indicated that no new or further intervention was required, and wrote a note to see care plan #10 for skin and mucous membrane. Id. at 94. I find that the nursing notes fail to state specifically whether the coccyx area was specifically observed.

In response to HCFA's arguments, the hospice asserts that, shortly after the home health aide noted the reddened area on the coccyx, there was an assessment of Patient 9's skin documented by the nurse. The hospice contends that the nurse assessed that there was no reddened area on the coccyx, or anywhere else on the patient's body, at the time the nurse examined her on June 14, 1999. Thus, there was no need to modify the patient's plan of care for skin and mucous membrane. P. Br. at 114. The hospice also points to a Home Health Aide note dated June 6, 1999, which did not mention any reddened areas on the patient's coccyx. HCFA Ex. 13 at 96. The hospice asserts further that Patient 9 was receiving interventions to prevent skin breakdown. P. Br. at 114 - 115.

I find that the June 14, 1999 nursing notes should have contained more specific documentation as to whether there was redness on Patient 9's coccyx area. I find that the documentation is inadequate to inform me whether the hospice nurse specifically observed Patient 9's coccyx area on June 14, 1999. I agree with HCFA that the fact that the nursing notes indicate that Patient 9's skin was pink and moist is not evidence that the coccyx area was specifically observed. Nowhere in the notes did the hospice nurse explicitly state that she had examined the coccyx area and whether it was reddened. Because the home health aide had noticed the reddened area on the patient's coccyx earlier that day, written about it in her note, and informed the nurse of this observation, there should have been at least some indication in the nursing notes that the nurse had performed a follow-up assessment as to whether the skin in the coccyx area was still red. Even if the nurse did not see the reddened area which the home health aide had observed, at the least, she could have documented that she had examined the coccyx area and determined whether or not further monitoring was needed.

Despite my conclusion that there is a lack of specificity in the documentation concerning the monitoring of Patient 9's skin, I find that the hospice's omission in documentation is insignificant when viewed in the context of the care provided to Patient 9. It is not disputed that Patient 9 had a care plan for the skin and mucous membrane. Tr. 756; HCFA Ex. 13 at 33. The fact that the hospice nurse failed to state explicitly that she had examined the patient's coccyx area is not evidence that the patient's skin care plan was not being maintained.

I conclude that the evidence, evaluated in accordance with 42 C.F.R. § 488.26, does not support a finding that the standard under Tag L133 was not satisfied with regard to Patient 9. There is no evidence to prove that the care provided to Patient 9 by the hospice was inadequate or that the hospice failed to meet the needs of Patient 9 in accordance with the applicable portion of 42 C.F.R. § 418.58. I find that HCFA has failed to establish a prima facie basis for this alleged deficiency.

The hospice's alleged noncompliance with the standard found at 42 C.F.R. § 418.58(b) (Tag L135)

At the hearing, the hospice objected to any discussion of Tag L135. Tr. 1296. The citation at Tag L135 references 42 C.F.R. § 418.58(b), which provides that, "The plan of care must be reviewed and updated, at intervals specified in the plan, by the attending physician, the medical director or physician designee and interdisciplinary group. These reviews must be documented." HCFA Ex. 1 at 13. HCFA alleged in the SOD that based on clinical record review and staff interview, the hospice failed to ensure that this was done for one of five skilled nursing residents. Id. at 13 - 14. According to the SOD, the surveyors conducted an interview with a hospice staff member who, when questioned by the surveyors, stated that, "I write approved by IDG (interdisciplinary group) and then each of the members [sic] names on the form, then the changes to the care plan is discussed during the meeting." Id. at 14.

The hospice specifically objected to discussion of this alleged deficiency, arguing that there was no notice given to the hospice about the patient or staff member to which it refers. Tr. 1296. Thus, there was no way for the hospice to prepare a response. Id. Further, the hospice pointed out that in its hearing request (at page 17), it contended that this Tag failed to provide sufficient notice of the deficiency alleged, "which patient record was reviewed, and which staff member was interviewed." Tr. 1298. Moreover, there was no allegation of a violation of the cited regulation. Id. Thus, the hospice could not prepare a defense. Id.

HCFA responded that, contrary to what was written in the SOD, the phrase "1 of 5 skilled nursing residents" does not refer to a particular resident, but to one of the five skilled nursing facilities where the hospice had patients in residence. Tr. 1296 - 1297; HCFA Br. at 83. HCFA explained that the word "residents" in the SOD is a typographical error, and the correct word should have been "residences." Tr. 1296; HCFA Br. at 83. HCFA stated that the "interview" referenced in the citation in the SOD was a confidential interview with one of the hospice staff members regarding her practices at the facility in question. Tr. 1296 - 1297. HCFA argued that it had a right to keep the staff member's identity confidential to protect the staff member from potential "feelings of retaliation." Tr. 1298.

During the hearing, I sustained the hospice's objection, because I agreed with the hospice that without the hospice's being able to cross-examine the staff member, there was no way to test whether there was some miscommunication or misunderstanding regarding the staff member's statement to the surveyors. Tr. 1301.

Regarding this Tag, and in response to the hospice's brief, HCFA asserts that allowing testimony on this alleged deficiency would not have involved a lack of notice to the hospice or any prejudice. HCFA contends that the hospice does not need to know who the staff member making the statement was in order to present its own evidence in support of an argument that the cited practice did not occur. HCFA Br. at 83 - 84. Further, HCFA proffers that if it had been permitted to present testimony from the surveyor who conducted the interview with the staff member and the surveyor who was present during the interview, HCFA could have offered evidence to prove that what the staff member said she did with respect to one of the nursing homes where she saw patients was a violation of the standard cited. Id.

I am not convinced by HCFA's arguments. I re-affirm my determination that, without the hospice's being able to cross-examine the staff member in question, there is no way to test whether some miscommunication or misunderstanding occurred. Thus, the hospice was unable to prepare a defense to the comments of the unidentified staff member, short of some general denial that the allegation asserted was the hospice policy. Accordingly, and in conformance with my earlier determination, I dismiss this alleged deficiency (Tag L135) from consideration.

The hospice's alleged noncompliance with the standard found at 42 C.F.R. § 418.58(c) (Tag L136)

In the SOD, under Tag L136, HCFA alleges the violation of 42 C.F.R. § 418.58(c), which states, in pertinent part:

The plan must include an assessment of the individual's needs and identification of the services including the management of discomfort and symptom relief.

HCFA contends that there were deficiencies for eight of nine patients, based on the allegation that "[t]here is no documented evidence of assessments of patients [sic] needs. The identified assessment only includes a list of symptoms or concerns." HCFA Ex. 1 at 14 - 15. Following this allegation is a recitation of the situations concerning four of the hospice's patients: Patients 1, 5, 4, and 9. HCFA Ex. 1 at 15 - 18.

As it did with Tag L133, the hospice raises a notice issue, alleging that HCFA failed to provide it with sufficient notice of the situations concerning the other four patients for the hospice to respondand prepare its defense. Thus, the hospice contends that the other four patients may not be used as a basis for termination in this case. The hospice argues further that, although the SOD states that "[t]he findings included but not limited to [sic]" the findings listed on the SOD, HCFA should not be permitted to allege any findings not stated in the SOD as a basis for termination, since the hospice had not received any notice. P. Br. at 117. The hospice then notes that HCFA did not submit any evidence at the hearing regarding the other four patients under this tag. Id.

HCFA is not allowed to base a termination on alleged deficiencies supported by incidents and/or documentation which occurred prior to the date on which the provider claims the corrective actions will be completed for deficiencies from the prior survey (the "Completion Date"). P. Motion [P. Br.] at 32 - 33. In the present case, HCFA improperly based some of the alleged deficiencies on documentation and/or incidents which occurred prior to the Completion Date and, therefore, these alleged deficiencies must be disregarded and cannot be considered as a basis for deficiencies for the June survey or for the termination action. Id.

P. R. Br. at 28.

In response to alleged deficiencies from the March 1999 survey, the hospice submitted a credible allegation to HCFA.

The Credible Allegation listed a Completion Date of May 15, 1999, for each of the deficiencies, which indicates that VITAS was alleging that the documentation generated and care provided to patients after May 15, 1999, would be provided using the revised procedures, forms and policies listed on the Credible Allegation. See Attachment E. This Credible Allegation was accepted by HCFA.

P. Br. at 33.

With regard to alleged deficiencies occurring between the exit date of the prior revisit survey (March 4, 1999), and the correction completion date contained in the hospice's credible allegation (May 15, 1999), I must determine on a case-by-case basis whether to consider the allegations. Under some circumstances, deficiencies occurring during that time frame could be the basis for termination. [A hospice does not enjoy a carte blanche type of free zone for deficiencies during such period.] Whether acts or omissions during that time frame will be considered depends on the nature of the alleged deficiencies and the nature of the hospice's correction. Here, under Tag L136, I find that the alleged deficiencies were based on the hospice not documenting assessments and services to be provided in a way HCFA regarded as satisfactory. Thus, with respect to Patient 4, HCFA must allow the hospice until the correction completion date, May 15, 1999, to change its method of documenting assessments, before citing it again with the same criticism.

SOD Finding 1 under Tag L136 - Patient 1

In the case of Patient 1, HCFA alleged in the SOD that her care plan for safety/hygiene stated that the nursing home staff was "to notify [the hospice] immediately if pt [patient] falls or injuries occur." However, HCFA contends that "[t]here is no documented evidence of an assessment of the patient's risk for falls." The SOD notes also that the care plan stated "Pt (patient) to call for assist [sic] to get OOB (out of bed)." HCFA then goes on to allege, "However, the patient was assessed to be confused. The plan of care failed to identify services based on the assessment." HCFA Ex. 1 at 15.

Based on the evidence, I find that Patient 1's care plan for safety/hygiene adequately assessed her needs, and thus, there is no basis to support a finding that the hospice failed to comply with the standard established by the regulation.

Patient 1 lived in a skilled nursing facility. Tr. 1329. According to the medical record, the primary caregiver was her son. P. Ex. 1 at 1. Patient 1 was diagnosed with end stage dementia. Id. at 17; see Id. at 9.

In Patient 1's interdisciplinary care plan for safety/hygiene, dated May 12, 1999, the interdisciplinary team has indicated at the top that the plan is related to the areas of "decreased mobility, safety." HCFA Ex. 4 at 25. With respect to "patient/family expectation," the team wrote "pt. confused, no family members avail." The care plan states that the team goal is that Patient 1 will not have any falls or injuries. The hospice listed the following interventions: "Pt. [patient] to call for assist [sic] to get OOB [out of bed]; "BSR's [bed side rails] up at all times when pt. in bed [sic] to be checked by all staff;" and "Nsg [nursing] home staff to notify [the hospice] immediately if pt falls or injuries occur." Id. The latter intervention is noted as being related to the area of "safety/weakness." Id.

HCFA argues in its brief that the care plan states only that the patient should not have any falls or injuries, "without further evaluating how much risk there was for such events to occur, and under what circumstances the patient might fall." HCFA Br. at 87. According to HCFA's surveyor, Cdr. Sadovich, "[t]here just wasn't any assessment of the patient's risk for falls, or how their status would necessarily lend itself to falls, or how that is necessarily an issue, or what the surrounding issues are in terms of relationships to their falls." Tr. 1304. Cdr. Sadovich testified that the fact that the care plan indicates that the patient has decreased mobility and is confused and weak, is not an assessment of her risk for falls. Tr. 1328. Moreover, the surveyor stated that the statement that the skilled nursing facility should notify the hospice if the patient falls does not constitute an assessment. Tr. 1343. With respect to the patient's confusion, HCFA argues that the care plan does not evaluate the degree of her confusion or "how her apparent confusion might affect either her risk for falls or her ability to call for assistance in getting out of bed." HCFA Br. at 87 - 88. The surveyor testified that the notation that the patient was confused does not constitute an assessment. Tr. 1346. HCFA contends also that the care plan fails to identify what services the hospice would provide to manage the patient's falls/injuries and her confusion. HCFA Br. at 88 - 89.

I am not persuaded by HCFA's contentions. I find that the care plan for safety/hygiene contains statements that indicate that the hospice did assess Patient 1's risk for falls, and the assessment was ongoing. On June 11, 1999, Patient 1 was assessed in her Plan of Care file, via the nursing notes, as having poor balance, poor coordination, and stiffness. HCFA Ex. 5 at 62. Moreover, the ongoing assessment under Patient 1's Plan of Care #9 for Safety, as contained in the June 11, 1999 nursing notes, indicated that Patient 1 had poor coordination, poor balance, and weakness. Id. at 63. These notations in the care plan provide sufficient information such that they can be considered an assessment of Patient 1's condition.

The interdisciplinary team thus recognized that Patient 1 had decreased mobility, safety, and weakness concerns. The care plan notations, taken together with the interdisciplinary team goal of "No falls or injuries," strongly suggest that Patient 1 has been assessed by the hospice and found to be at risk for falls.

The interdisciplinary team indicated that Patient 1 was confused and that she was to call for assistance to get out of bed. Contrary to HCFA's arguments, these two items are not necessarily in conflict. A patient who is confused may also be capable of calling for assistance. The surveyor admitted that Patient 1 was described as "alert with periods of confusion." Tr. 1337; P Ex. 1 at 18. With this intervention, the hospice further recognizes Patient 1's functional limitations and addresses her safety concerns. Had the hospice not included this intervention on the care plan, Patient 1's safety could have been compromised, placing her at higher risk for falls and injuries.

Moreover, as pointed out by the hospice, in Patient 1's initial plan of care, dated November 26, 1998, the hospice staff documented, among other things, that she was unable to ambulate and required assistance with transfers. P. Ex. 1 at 17. This information is further evidence to support a finding that there was an assessment of Patient 1's condition. One can reasonably conclude from the initial plan of care that the hospice assessed that Patient 1 was at risk for falls.

The documentation shows that the hospice coordinated with the skilled nursing facility to prevent Patient 1 from falling or being injured. P. Ex. 1 at 35; HCFA Ex. 4 at 25. The hospice was aware of the nursing home care plan, which noted that Patient 1 was "[a]t risk of fall/injury related to general weakness secondary to medical condition and taking psychotropic medication." P. Ex. 1 at 35; see Tr. 1331. The hospice directed the nursing home staff to notify it immediately if Patient 1 fell or injuries occurred, and the services that the hospice undertook were to ensure that Patient 1 would call for assistance to get out of bed, and to ensure that Patient 1's bed side rails were up at all times when she was in bed, to be checked by all staff. HCFA Ex. 4 at 25. At the hearing, Cdr. Sadovich admitted that she didn't see any evidence of falls or injuries on the part of Patient 1. Tr. 1341.

Finally, I find that Patient 1's care plan for safety did identify services based on the assessment that she was confused. The services that the hospice undertook, with respect to the patient's confusion, were to ensure that the patient would call for assistance to get out of bed, and to ensure that the patient's bed side rails were up at all times when she was in bed, to be checked by all staff. HCFA Ex. 4 at 25.

I find that HCFA has not established a prima facie basis that the hospice failed to satisfy the standard under Tag L136 by failing to assess Patient 1 or failing to identify services for Patient 1. Based on the evidence regarding Patient 1, there is no standard-level deficiency under Tag L136.

SOD Finding 2 under Tag L136 - Patient 5

With respect to Patient 5, HCFA alleges in the SOD that this patient had an order dated April 22, 1999, for five-day respite care at a skilled nursing facility. The SOD goes on to allege: "As of 6/21/99, patient 5 was still living in the skilled nursing facility. The clinical record had no documented evidence as to why patient 5 could not return home." HCFA Ex. 1 at 15. Moreover, according to the SOD, "the General Manager/Director of Nurse [sic] (of hospice)" had been "unable to provide documentation as to why [Patient 5's] goal of returning home had not been documented/assessed." Id.

I conclude to the contrary; the evidence supports a finding that the hospice satisfied the standard under Tag L136 and met Patient 5's needs in accordance with 42 C.F.R. § 488.26. Patient 5 had a diagnosis of colon cancer. P. Ex. 5 at 1. The records contain a physician's order dated April 21, 1999, approving the transfer of Patient 5 to a nursing home for a 5-day respite. HCFA Ex. 9 at 3; P. Ex. 5 at 9.⁽¹²⁾ Patient 5 continued to reside in the nursing home after that respite period was over, and at the time of the June 1999 survey, was still there. Tr. 1351 - 1354; see HCFA Ex. 1 at 15.

I find that the evidence does document why Patient 5 could not return home. In fact, the surveyor who testified concerning this patient admitted that the statement that the clinical record contained no documented evidence as to why Patient 5 could not return home, was incorrect. Tr. 1380. Specifically, on April 26, 1999, which is immediately after the respite period (Tr. 1360), the hospice physician documented on a Supplemental Interdisciplinary Note that ". . . Since adm. to service, pt. has had progressive weakness & inability for the caregiver to provide appropriate care. Therefore, he was transferred to Royalwood Care Center on 4/21/99. He has developed urinary retention & now has Stage I pressure lesions." HCFA Ex. 9 at 28. This note is considered to be part of Patient 5's plan of care. Tr. 1361. As such, it constitutes an assessment of the reason Patient 5 continued to reside in the skilled nursing facility after the conclusion of the respite period, specifically, that Patient 5's caregiver could not provide appropriate care given his deteriorating condition. See also, P. Ex. 5 at 8, 10, 12, 15; Tr. at 1379 - 1380. Thus, Patient 5's assessment immediately following his five days of respite care is documented and shows why Patient 5 could not return home.

SOD Findings 2 (sic)⁽¹³⁾ & 3 under Tag L136 - Patient 4

HCFA alleges in the SOD, "There was no evidence of an assessment as to the need for a change in pain medications." HCFA Ex. 1 at 16. On February 9, 1999, Patient 4's pain medication was switched from Vicodin (tablet form) to Lortab elixir (liquid form), to be given every six hours and as needed every three hours. HCFA Ex. 8 at 5. HCFA could not find "an assessment as to the basis for changing the patient's pain medication," or documentation showing "why the prior interventions were deemed inadequate to address the patient's comfort level." HCFA Br. at 94; see HCFA Ex. 1 at 16.

The next aspect of Patient 4's pain management that concerned HCFA occurred in June 1999, and I will consider it. HCFA expected the hospice documentation to acknowledge and show a response to the nursing home staff's observation of repeated instances of Patient 4's pain at level 4. HCFA Ex. 1 at 16 - 17; HCFA Br. at 94. According to the SOD,

[there] had been 8 days in June (6/10/99 - 6/23/99) when [Patient 4's] pain level was noted by nursing home staff to be at level 4. The nursing note dated 06/16/99 indicated the pain scale to be 0 on a scale of 0 - 10. The Case Conference Summary for the period of 06/02/99 to 06/16/99 stated: "patient comfortable, assessed on non-verbal scale, no facial grimacing; pain management effective with Loritab elixir." There was no documentation in the hospice record they were aware of the increase in pain level nor was there an assessment as to the cause for the increase in pain.

HCFA Ex. 1 at 16 - 17.

The hospice used a non-verbal scale to evaluate pain, which I would expect to be especially helpful for Patient 4, a 65 year-old whose terminal diagnosis was "cerebral degeneration (dementia) except Alzheimer's." HCFA Ex. 8 at 1. She was nonverbal. She also had dysphagia (difficulty swallowing) and anorexia. The hospice scale was different from the scale used by the nursing home, but both providers had documented Patient 4's pain level as zero, at one or more times during the first three weeks of June 1999. HCFA Ex. 8. Thus, the evidence shows that Patient 4's pain was, at times, zero, and, at times, as high as 4 on a scale of 0 - 10. The "as needed" availability of the Lortab elixir suggests that we would not expect Patient 4's pain level to remain constant. HCFA did not prove that the hospice was unaware of or unresponsive to Patient 4's pain level. HCFA did not prove that Patient 4's pain management should have been different. HCFA did not prove that the hospice's method of documenting Patient 4's pain assessments and services to be provided was inadequate. See discussion infra under Tag L124. I find that HCFA failed to establish a prima facie case under Tag L136 that the hospice was deficient regarding documenting Patient 4's pain assessments and services to be provided.

Patient 4's nutritional needs, given her anorexia and weight loss, were also found by HCFA to be inadequately addressed in documentation of assessments and services to be provided. HCFA Ex. 1 at 17 - 18. Patient 4's plan of care for food/fluid is found in HCFA Ex. 8 at 7 - 8, and P. Ex. 4 at 110 - 113. The plan of care noted that Patient 4's husband just wanted her to eat as long as she could. The team goal was that she would be provided nourishing meals and supplements as tolerated. The skilled nursing facility was feeding Patient 4 a pureed diet with no concentrated sweets; eight ounces of high protein nourishment, in-between-meals, three times a day; and a multi-vitamin, vitamin C, and zinc, in order to assist metabolism. The hospice nurse was to encourage her intake and to monitor the percent of her meals consumed every visit. Tr. 905 - 908; HCFA Ex. 8 at 7 - 8, 21, 104. HCFA stated suggestions in the SOD for additional nutritional effort, such as assessing Patient 4's food preferences, use of alternative food forms (i.e. finger foods), favorite meals, or length of time needed to eat. HCFA Ex. 1 at 17 - 18. These may be good ideas, though Patient 4's dysphagia would be expected to impose certain limits, but I find that a failure to have incorporated these ideas would not constitute, under the regulation, a failure to document Patient 4's nutritional assessments and services to be provided. The SOD also states, at 18, "Nor was there evidence of other factors which may impact appetite such as the effects of pain, constipation, blood glucose levels or use of antipsychotic medications and social isolation." What was meant in the SOD, I believe, was that the surveyors did not find evidence that such factors had been evaluated or assessed. The record contains evidence to the contrary, but again, a failure to document evaluation or assessment of such factors would not constitute, under the regulation, a failure to document Patient 4's nutritional assessments and services to be provided. I find that HCFA failed to establish a prima facie case under Tag L136 that the hospice was deficient regarding documenting Patient 4's nutritional asessments and services to be provided.

SOD Finding 4 under Tag L136 - Patient 9

This situation, described on page 18 of the SOD (HCFA Ex. 1 at 18), is detailed above under Tag L133. Here, under Tag L136, I again find that the documentation is inadequate to inform me whether the hospice nurse specifically observed Patient 9's coccyx area on June 14, 1999. Nevertheless, there was no evidence that the care provided to Patient 9 failed to meet her skin care needs.

Accordingly, as under Tag L133, I conclude that the hospice's documentation omission is insignificant and does not support a finding of noncompliance with the standard under Tag L136. The evidence does not show a failure by the hospice to provide Patient 9 with the skin and mucous membrane assessments she needed or to provide her with the services that met her skin care needs. Thus, based on the evidence regarding Patient 9, I find that HCFA failed to establish a prima facie basis that the hospice failed to satisfy the standard under Tag L136.

With regard to "[P]atient 9's care plan #5 which was written for food/fluid on 1/25/99" (HCFA Ex. 1 at 18), the time of the alleged deficiency is not under consideration here. In determining whether the hospice had deficiencies at the time of the June 1999 survey, I will not consider deficiencies that occurred on or before the exit date of the prior revisit survey, on March 4, 1999.

The hospice's alleged noncompliance with the standard found at 42 C.F.R. § 418.58(c) (Tag L137)

The content of the plan of care must state in detail the scope and frequency of services needed to meet the patient's and family's needs.

HCFA alleges deficiencies for six patients: Patients 5, 7, 6, 4, 2, and 9. HCFA Ex. 1 at 18 - 24.

SOD Finding 1 under Tag L137 - Patient 5

HCFA alleges that three care plan items for Patient 5 "failed to state in detail the scope and/or frequency of services." HCFA Ex. 1 at 19 - 20. The three items concern "Elimination," "Emotional Reaction," and "Safety/Hygiene." With regard to this alleged deficiency regarding Patient 5 under Tag L137, I adopt and incorporate the hospice's reasoning, which I summarize here. P. Br. at 139 - 150.

Cdr. Sadovich testified that hospices must state in the plan of care what they are doing for the patient, when or how frequently they want it done, and who is supposed to perform the intervention. See, e.g., Tr. at 1397 - 1398; 1402 ("Who, how, and when, exactly, are they going to do that?"). In order to determine compliance, Cdr. Sadovich examined the list of interventions or actions ordered by the IDG in order to determine if the scope and frequency, as she defines it, are listed in the interventions.

For example, Cdr. Sadovich criticized the intervention listed for Patient 5 on the plan of care for Elimination that instructed the nurse to "[m]onitor skin for signs of redness, breakdown," alleging that this intervention failed to state how frequently the staff was performing the assessment, who is doing the assessment, and what part of the body was to be assessed. HCFA Ex. 1 at 19; Tr. 1397 - 1398.

The regulation at L137 requires that the "scope" and "frequency" of the services must be listed in the plan of care. The regulation does not define these terms and HCFA has not issued any official interpretations that specifically define these terms. Tr. 1615, 1617. Therefore, the common usage of these terms would apply to assist hospices in complying with this regulation.

The meaning of the word "frequency" in this regulation does not appear to be in controversy as much as the meaning of the word "scope." According to its common meaning, the term "scope" means "the extent of treatment." Webster's Collegiate Dictionary, 10^th Ed. (1996) at 1047.

In the SOD, HCFA alleges that the care plan for Patient 5 fails to state in detail the scope and/or frequency for the following services:

Elimination - "Monitor skin for signs of redness, breakdown."

Emotional Reaction - "Provide active listening and companionship. Affirm right to express emotional pain." "Assist with coping with terminal diagnosis and anticipated grief." "Explain pt.'s (patient's) spiritual issues. Help pt. (patient) find spiritual strength and hope through theological reflection and prayer." "Facilitate adjustment to care center placement."

Safety/Hygiene - "Monitor pt.'s (patient's) ability to transfer and ambulate." "Reinforce safety and fall precautions."

HCFA Ex. 1 at 19.

Cdr. Sadovich testified that the hospice failed to state either the scope or frequency for the listed interventions. Tr. 1397 - 1398. She then clarified that the primary problem with these interventions was the lack of a statement of the frequency of the intervention. Tr. 1398 (" . . . predominantly it's the frequency in this case"). However, contrary to HCFA's allegations, the hospice did comply with this regulation by ensuring that the scope and frequency for the cited interventions are documented on the plan of care.

As Cdr. Sadovich conceded, the Plan of Care Case Conference Summaries are considered to be part of the hospice plan of care. Tr. 1408 - 1409. In addition, as Cdr. Sadovich conceded and as the hospice informed HCFA in the Credible Allegation submitted to HCFA following the March survey, the frequency of the visits by all hospice disciplines is reviewed by the hospice IDG and then listed on the Interdisciplinary Case Conference Summaries. Tr. 1409. See HCFA Br., Attachment A at 61; see, e.g., P. Ex. 5 at 2, 3, 6, 7, 18, 27 for Case Conference Summaries for Patient 5.

For example, on the Case Conference Summary covering the period from May 26, 1999 to June 9, 1999, the nurse was assigned to visit Patient 5 one to two times a week and the home health aide was assigned to visit two to three times a week. P. Ex. 5 at 54. The services provided by each of the hospice professionals were listed on the numbered Plan of Care forms. Tr. 1405 - 1408, 1415. For example, for Patient 5, the nurse was assigned to monitor the patient's skin condition. See P. Ex. 5 at 18 (The "Disc." [discipline] box states that the RN was assigned to monitor the skin for redness and breakdown).

HCFA failed to establish a basis for its allegations that the scope of these services was not listed in the plan of care. Each of the interventions listed for Patient 5 under Tag L137 as an area of deficiency describes activities that professionals in the field would readily understand and carry out due to that professional's training, education, and understanding of the professional standard of practice in that discipline. For example, the registered nurse assigned to "monitor skin for redness and breakdown" would be able to carry out these instructions based on her training and the professional standards of nursing practice. Cdr. Sadovich, despite her reluctance to admit this, understood perfectly, due to her training in the professional standards of nursing practice, that this order meant to observe, monitor or look out for redness or skin breakdown on all parts of the patient's body skin area. Tr. 1416 - 1423. Therefore, the scope of the nurse's skin monitoring is clearly stated in this intervention, contrary to HCFA's assertions under Tag L137.

SOD Finding 2 under Tag L137 - Patient 7

With regard to this alleged deficiency regarding Patient 7 under Tag L137, I again adopt and incorporate the hospice's reasoning, which I summarize here. P. Br. at 139 - 156. The alleged deficiencies under Finding 2 appear to be based on the fact that the hospice does not complete the section entitled "Team goal, if changed" on the "shingles" which are used to update the patients' plans of care, unless the team goal actually changes on that date. HCFA Ex. 1 at 20 - 22. When that section of the form is left blank, the previously established team goal remains in effect. Perhaps the alleged deficiencies that were based on the goal having been left blank, would not have been cited, if the surveyors had understand the hospice's procedure.

The meaning of the word "scope" is dramatically different from the meaning of the word "goal," which means the "end toward which effort is directed." Webster's Collegiate Dictionary at 499. Notably, the definition for "scope" does not include "goal," nor are any of the definitions for the term "scope" synonymous with the term "goal," as Ms. Garces claims. Based on the common meaning of the words, therefore, there is no basis for Ms. Garces' contention that the "scope" of services in the plan of care is defined solely by a statement of the goals for that plan of care. Tr. 1579 - 1617.

The hospice indicates that there is also no definition of the word "scope" in the Interpretive Guidelines (IG) for the regulation at Tag L137. The IG list some "probes" that the surveyors are required to ask in a hospice survey to determine compliance with Tag L137. See P. Br., Attachment C. These probes all pertain to ensuring that the patient is receiving the hospice services he/she requires. Id. The hospice asserts that nothing in the language of the IG even suggests that "scope" is defined as goal. Rather, the hospice maintains, it appears that the IG intend that the surveyor review the entire plan of care in order to determine if the scope and frequency of the services is stated and to determine if the patient's needs are being met.

Based on the foregoing, the hospice contends that the surveyors' interpretation of this regulation, particularly Ms. Garces' interpretation of this regulation that "scope" is defined as "goal," is not reasonable and therefore, may not be used as a legitimate basis for this allegation. The hospice states that it is also unreasonable for HCFA to interpret this regulation to mean that the plan of care must state exactly which discipline is providing the services, as Ms. Sadovich expressed in her testimony. Tr. 1398, 1402. At least one of the surveyors admitted that the citations to deficiencies under this regulation are not based on a failure to state which discipline will be performing the service. Tr. 1413. This alleged requirement is not expressly stated in the regulation at L137 or in the IG for this regulation and is unreasonable, argues the hospice. Nevertheless, one of the surveyors conceded that there is documentation on the plan of care that indicates who will be providing service to hospice patients. See, e.g., Tr. 1407 - 1408, 1415.

SOD Finding 3 under Tag L137 - Patient 6

In its opening brief, at footnote 33, the hospice contends that "[t]here was absolutely no testimony or evidence presented at the hearing regarding Finding #3 (Patient #6) under L137. Therefore, this allegation must be disregarded for purposes of this termination action." P. Br. at 141 n.33; see P. Br. at 151.

Nevertheless, I will address the alleged deficiency in the SOD. HCFA does not dispute the hospice's claim that it did not present any evidence at the hearing concerning the allegations under Finding 3. In its response brief, HCFA alleges that the hospice plan of care for Patient 6 failed "to specify any scope of the plan for food/fluid as related to the patient's anorexia/weight loss." HCFA Br. at 142. HCFA did not discuss this allegation further.

HCFA did not discuss Finding 3 at all other than to mention it (i.e., Patient 6) in a cursory fashion when summarizing the deficiencies listed under Tag 137. The alleged deficiency regarding Patient 6 appears to be based on the fact that, on a June 25, 1998 care plan update ("shingle") related to the patient's anorexia/weight loss, the hospice did not complete the sections entitled "Patient/Family Expectation, if changed" and "Team Goal, if changed." These sections have been left blank. See HCFA Ex. 1 at 22; HCFA Ex. 10 at 14.

As I stated above in my discussion concerning Patient 7 under this tag, the hospice would not complete the section "Team Goal, if changed," on the care plan update ("shingle") unless the team goal actually changed. This would also hold true for the section, "Patient/Family Expectation, if changed." When these sections of the care plan update ("shingle") are left blank, the previously established patient/family expectation and team goal remain in effect.

The intervention on the June 25, 1998 care plan update ("shingle"), which was approved by the interdisciplinary group, states that the hospice nurse "will assess dietary intake and offer suggestions as appropriate for pt. condition/disease progression q visit." HCFA Ex. 10 at 14. I find that the scope and frequency of this intervention is evident. I find that HCFA has failed to establish a deficiency under Tag L137 for Patient 6.

SOD Finding 4 under Tag L137 - Patient 4

With respect to Patient 4, who was discussed previously, the SOD alleges that the care plan for pain management contains an on-going intervention, updated May 21, 1999, which states that the nursing home would assess the patient for signs and symptoms of pain and was to notify the hospice of increased pain or pain unrelieved by medication. HCFA Ex. 1 at 22. Additionally, the SOD states that the hospice had added an entry to Patient 4's nursing home care plan that the nursing home was to call the hospice if the patient had pain at a level of 2 or above on the non-verbal scale of 0 - 10. However, contends the SOD, "[t]here was no indication as to when or how often the pain scale assessment should occur." HCFA Ex. 1 at 22; see HCFA Ex. 8 at 85.

I do not agree with HCFA's allegations that the above-mentioned interventions relating to Patient 4's pain management and pain scale assessment do not state in detail the scope and frequency as required under the regulation. Thus, there is no basis to support a finding that the hospice failed to comply with the standard established by the regulation.

At the hearing, Cdr. Liebmann testified concerning this alleged deficiency. With respect to the intervention in Patient 4's pain management care plan, Cdr. Liebmann testified that it does not state "what days of the week they will assess the pain, what shifts they will assess the pain, or how often during each shift . . . There is no indication which long term care staff is responsible for assessing the pain." Tr. 1084; see Tr. 1098. Cdr. Liebmann stated that the intervention "doesn't state the scope and frequency." Tr. 1098. As to the latter part of the deficiency citation relating to the pain scale assessment, Cdr. Liebmann asserted that the basis for this finding was that "there's no indication who would do that assessment . . . no indication as to how often it should be done, what time of day the pain assessment should be done." Tr. 1083; see Tr. 1085, 1091. Cdr. Liebmann stated that the care plan entry "did not identify the scope and frequency of when the pain should be assessed and when to give the appropriate pain medication as needed." Tr. 1087.

In examining the two care plan interventions in question, I find that the scope of services is adequately stated. As written, the care plan interventions contain sufficient information describing what type of care the nursing home staff was to be rendering to Patient 4. The interventions address the management of Patient 4's pain and the assessing of her pain by the nursing home staff.

Although the care plan interventions do not specify when or how often the pain assessments should occur, I find also that the interventions satisfy the frequency requirement under the regulation. The hospice contends that there was no need to explicitly state how often these interventions should be carried out, because professional standards of nursing practice dictate that certain types of assessments, such as skin and pain assessments, are to be performed by a nurse automatically each time the nurse observes a patient. This argument was not contradicted by Cdr. Liebmann. On cross-examination, Cdr. Liebmann agreed that the intervention, "Long-term care facility to assess patient for signs and symptoms of pain," carries an implicit expectation that as "good nursing practice," the staff should assess Patient 4 for pain upon each professional contact with the patient. Tr. 1090. Cdr. Liebmann testified that "[i]ndirectly you could say [frequency] was there." Tr. 1092. Although she qualified her response by stating further that doing a pain scale assessment would involve more methodology than mere observation of the patient, Cdr. Liebmann admitted that the signs and symptoms of pain are ascertainable by observing the patient. Tr. 1092 - 1093; see Tr. 1091. Thus, although the frequency for carrying out the interventions was not explicitly spelled out, I am persuaded that the nursing home staff members would know that they were to perform a pain assessment each time one of them saw Patient 4.

Cdr. Liebmann conceded that if nursing home staff had memorized the non-verbal pain scale, it would be possible for them to determine how much pain the patient was experiencing by observing her. Tr. 1093. She acknowledged that the nursing home staff had received training on the non-verbal pain scale. Tr. 1093 - 1094.

I note also that Cdr. Liebmann modified her testimony as to what the regulation requires. Cdr. Liebmann conceded on cross-examination that the deficiency was not based on a failure to indicate how frequently the pain medication would be given. Tr. 1087 - 1088. She admitted also that the deficiency was not based on a failure to designate which nursing home staff member would be doing the pain assessment. Tr. 1102.

The evidence is insufficient for me to find that the hospice failed to state the scope and frequency of services, as required under 42 C.F.R. § 418.58(c), for Patient 4 under SOD Finding 4 under Tag L137. I find that HCFA has failed to establish a prima facie basis for this alleged deficiency.

SOD Finding 5 under Tag L137 - Patient 4

Patient 4, who was discussed under the previous finding, is also the subject patient of this finding. Under this finding, HCFA contends in the SOD that while Home Health Aide/Homemaker notes indicated that both passive and active range of motion (ROM)⁽¹⁴⁾ had been provided, there was no evidence of an order for ROM on the Interdisciplinary Care Plan, nor was there "any reference to the duration, scope and frequency" of the intervention. HCFA Ex. 1 at 22 - 23. Moreover, HCFA alleges that the "hospice addendum to the nursing home care plan . . . did not include any interventions for the hospice [home health aide] to provide [ROM]." Finally, HCFA contends that the nursing home care plan for [ROM] stated that the nursing home restorative aide would provide passive ROM, with no mention that the hospice staff was also providing this care. Id. at 23.

I conclude that HCFA's allegations concerning the ROM interventions for Patient 4 are without basis.

With respect to the Home Health Aide/Homemaker Request form dated May 24, 1999, Cdr. Liebmann testified that it indicates that the home health aide will visit two to three times a week. Tr. 1122, 1133; see HCFA Ex. 8 at 14; P. Ex. 4 at 185.⁽¹⁵⁾ Cdr. Liebmann stated further that, while the request form indicates that active and passive ROM are the activities to be performed by the home health aide, it does not specify whether ROM exercises are to be done on each visit or the duration of the ROM activity. Tr. 1122. Moreover, Cdr. Liebmann testified that the request form did not indicate the scope of the ROM activity, i.e., which body part or which extremities were to receive ROM exercises. Tr. 1122 - 1123.⁽¹⁶⁾

With respect to the Home Health Aide/Homemaker Notes (see HCFA Ex. 8 at 44 - 50), Cdr. Liebmann testified that the notes show only that passive and active ROM were performed by the home health aide. See Tr. 1123 - 1126. Cdr. Liebmann stated that nowhere in the notes did the home health aide specify the scope and frequency of the ROM activity. Tr. 1124, 1126.

Cdr. Liebmann explained that frequency is "measured by the number of repetitions done in exercising a particular body part." Tr. 1124. That may be one interpretation of frequency, but other interpretations could also be valid. For example, the number of times during a day or during a week or during a month might also indicate frequency.

On cross-examination, however, Cdr. Liebmann conceded that the frequency of the ROM activity is documented on the Home Health Aide/Homemaker Request form dated May 24, 1999. Cdr. Liebmann admitted that, since the home health aide visits would be occurring two to three times a week and the home health aide would presumably be performing active and passive ROM exercises at each visit, the request form does indicate the frequency of the active and passive ROM exercises. Tr. 1134; see Tr. 1135.

With respect to the "scope" requirement, the hospice asserts that the reference to active and passive ROM sufficiently conveys the scope of the ROM activity. P. Br. at 160 - 161. Moreover, the hospice asserts that Cdr. Liebmann's opinions regarding ROM orders should not be given any weight since she admitted she has not received any formal training on ROM and is not qualified to perform ROM under her license. P. Br. at 161; See Tr. 1137. The hospice contends that Cdr. Liebmann's testimony was unsupported by any authoritative source concerning the appropriate manner in which ROM orders are to be written.

I do not read the plain meaning of the regulation as requiring the level of detail which Cdr. Liebmann interpreted it to require. There is nothing in the regulation that specifically requires ROM orders to identify specific body parts or state the number of repetitions. Moreover, I agree with the hospice that Cdr. Liebmann does not possess the necessary qualifications or expertise to opine whether a ROM order was adequately written. Cdr. Liebmann testified that she has not performed ROM activities. Tr. 1138. I do not find that her experience as a registered dietician and dietary consultant qualifies her to attest to what should be contained in a ROM order. Moreover, HCFA did not offer any expert testimony or other evidence, other than Cdr. Liebmann's testimony, to support its interpretation.

Accordingly, I conclude that the ROM interventions contained in the Home Health Aide/Homemaker Request, as well as the Home Health Aide/Homemaker Notes, adequately comport with the scope and frequency requirements of 42 C.F.R. § 418.58(c). I find that the fact that the Request form and Notes state that Patient 4 would be receiving active and passive ROM sufficiently addresses the scope of the ROM activities. Also, as Cdr. Liebmann admitted, the request form does indicate the frequency of the ROM intervention in that the frequency can be inferred from the number of home health aide visits.

I also note that the regulation does not contain any requirement that the duration of an intervention be specified. Indeed, Cdr. Liebmann conceded that no such requirement existed. Tr. 1136.

Furthermore, I note that Cdr. Liebmann apparently was under the misimpression that the Home Health Aide/Homemaker Request form was not part of the plan of care, and this formed the basis for her statement in the SOD that there was no documentation of ROM activity on the interdisciplinary care plan. See Tr. 1132. However, Cdr. Liebmann testified that she became aware prior to the hearing that the request form is considered by the hospice to be part of the plan of care, and acknowledged this fact at the hearing. Tr. 1121, 1153 - 1154; see Tr. 1131 - 1132. Moreover, the hospice directed Cdr. Liebmann's attention to the fact that, under the hospice's written care plan policy, the Home Health Aide/Homemaker Request form is considered by the hospice to be part of the "working care plan file." Tr. 1155 - 1156; see P. Ex. 30 at 3. Thus, contrary to what was alleged in the SOD, it is clear from the record that Patient 4's care plan did contain documentation that ROM activity was to be performed since this intervention was contained on one of the documents designated by the hospice as being part of a patient's care plan file.

Moreover, there was no showing by HCFA that the ROM activity provided to Patient 4 was either inadequate or in excess of what she needed, or that the hospice failed to meet the ROM needs of Patient 4 in accordance with 42 C.F.R. § 418.58(c).

There is insufficient evidence to show that the hospice failed to state the scope and frequency of the ROM interventions for Patient 4 under Tag L137. I find that HCFA has failed to establish a prima facie basis for this alleged deficiency.

SOD Finding 6 under Tag L137 - Patient 2

With respect to Patient 2, HCFA alleges in the SOD that "[t]here was no documented evidence of the duration, scope and frequency of when [Patient 2's] splint should be applied" and "[t]here was no indication on either the hospice or nursing home plan of care that ROM would be provided by the hospice HHA [home health aide], nor was there documentation indication [sic] duration, scope and frequency of the range of motion." HCFA Ex. 1 at 23 - 24.

I conclude that HCFA's allegations are without support in the record.

I shall first discuss HCFA's contention regarding Patient 2's splint. Patient 2's hospice care plan for safety/hygiene stated the following intervention relating to range of motion/weakness: "Splint per MD order; to be paid by hospice." This intervention is dated March 18, 1999. HCFA Ex. 6 at 10; P. Ex. 2 at 96.

The surveyor, Cdr. Liebmann, testified that this intervention, as written in the (hospice) care plan, did not indicate the scope and frequency regarding the use of the splint. Tr. 1159, 1168, 1169. She stated that the intervention does not provide any information as to the location of the splint or how long the patient was to wear the splint. Tr. 1162 - 1164.

The hospice responded to Cdr. Liebmann's testimony by asserting that the physician's order ("MD order") which is referenced in the March 18, 1999 care plan intervention contains a complete description of the use of the splint. P. Br. at 163. This physician's order is listed on a separate document and is dated March 18, 1999, which is also the date of the care plan intervention. The order states as follows: "Apply (R) ue [upper extremity] hand splint to prevent loss of rom to wrist and finger extension. Max 6 hrs release Q 2 hrs x 15 mins check for redness & circulation." P. Ex. 33 at 2. On cross-examination, Cdr. Liebmann did not dispute that this physician's order was the "MD order" referenced in the care plan intervention. Tr. 1172 - 1173. In fact, Cdr. Liebmann essentially conceded that she had not seen this order during the survey or made any inquiries of the hospice staff as to what particular "MD order" was being referenced in the intervention. Tr. 1174 - 1175.

It is thus clear from the record that the care plan intervention incorporated the March 18, 1999 physician's order concerning the use of the splint. Moreover, I agree with the hospice that the March 18, 1999 physician's order, which was incorporated into the care plan intervention, satisfies the scope and frequency requirements of 42 C.F.R. § 418.58(c). The physician's order, as written, states detailed instructions and addresses scope and frequency regarding application of the splint. Furthermore, Cdr. Liebmann did not dispute on cross-examination that this order does indicate the duration, scope and frequency of when the splint should be applied. Tr. 1175. Consequently, I find that Cdr. Liebmann's testimony on direct examination that the care plan intervention lacked any information regarding the splint is not supported by the record. I conclude that HCFA has failed to establish that the care plan intervention does not state the scope and frequency for use of the splint.

HCFA makes other allegations in the SOD concerning Patient 2's documentation. HCFA states that a hospice Home Health Aide/Homemaker Note indicated that the patient was receiving active and passive ROM. HCFA asserts further that the nursing home care plan stated that ROM would be conducted by the nursing home restorative aide. See HCFA Ex. 1 at 23. HCFA points also to a May 21, 1999 hospice entry to the nursing home care plan, which indicated agreement with the nursing home's approach regarding ROM. See Id.; HCFA Ex. 6 at 22. Based on the foregoing, HCFA contends in the SOD that neither the hospice nor nursing home care plans indicated that "ROM would be provided by the hospice HHA." HCFA Ex. 1 at 23 - 24. Morever, HCFA alleges that there was no "documentation" indicating the "duration, scope and frequency of the range of motion." Id. at 24.

First, in reviewing the hospice care plan, I find HCFA's contention that the care plan did not indicate that a home health aide would be providing ROM to have no basis in the record. The "Home Health Aide/Homemaker Note" form used by the hospice states at the top "Plan of Care File." Thus, one cannot dispute that the Home Health Aide/Homemaker Note, which indicated that the patient was receiving active and passive ROM, is part of Patient 2's care plan. Moreover, this form was completed and signed by a home health aide. HCFA Ex. 6 at 18. The fact that the Note was signed by a home health aide presumably indicates that a home health aide will perform these activities with Patient 2 at each visit.

With respect to HCFA's claim that Patient 2's nursing home care plan does not indicate that ROM would be provided by the hospice HHA, I agree. The nursing home care plan in question states, among other things, "ROM exercises to all extremities by RNA [restorative nursing aide]." HCFA Ex. 6 at 34. In its brief, HCFA contends that "the nursing home had its own contradictory plan for ROM and was performing its own ROM on the patient." HCFA Br. at 137. I am not persuaded by HCFA's arguments. As I did with Patient 4, I conclude that the fact that ROM orders are contained in two different care plans does not, in and of itself, constitute noncompliance with 42 C.F.R. § 418.58(c). Moreover, as was the case with Patient 4, there was no showing by HCFA

that these allegedly contradictory ROM orders failed to meet the needs of Patient 2 in accordance with the applicable portion of 42 C.F.R. § 418.58.

Further, as I noted earlier, 42 C.F.R. § 418.58(c) does not contain any requirement that the hospice care plan must state the "duration" of services needed to meet the patient's and family's needs. It is true that the hospice care plan for Patient 2 does not mention the duration of the ROM intervention. However, this failure to mention the duration has no bearing on my analysis.

Moreover, there was no showing by HCFA that the ROM activity provided to Patient 2 was either inadequate or in excess of what she needed, or that the hospice failed to meet the ROM needs of Patient 4 in accordance with 42 C.F.R. § 418.58(c).

The evidence was insufficient for me to find that the hospice failed to state the scope and frequency of the ROM interventions for Patient 2 under Tag L137. I find that HCFA has failed to establish a prima facie basis for this alleged deficiency.

SOD Finding 7 under Tag L137 - Patient 9

With respect to Patient 9 under Tag L137, HCFA alleges in the SOD that there is a deficiency based on the following: Patient 2's care plan #2 for comfort "did not specify the reason for giving Roxanol" and the patient's care plan #10 for skin/mucous membrane "failed to identify the affected area" for the use of Calmoseptine cream. See HCFA Ex. 1 at 24.

I find that HCFA's allegations relating to Patient 9 are without support in the record and do not demonstrate noncompliance with 42 C.F.R. § 418.58(c).

With respect to the use of Roxanol, the evidence indicates that, on June 1, 1999, the hospice nurse stated in a nursing note that Patient 9 had complaints of chest area pain as a result of a chronic cough and contacted the attending physician, who ordered 5 mg. of Roxanol. P. Ex. 9 at 45; HCFA Ex. 13 at 67. That same day, Patient 9's care plan #2 for comfort was updated with the intervention that 5 mg. of Roxanol was to be given orally every four hours as needed. P. Ex. 9 at 9; HCFA Ex. 13 at 16. The intervention for Roxanol had been approved by the interdisciplinary group. Id.

The hospice points out that the order for Roxanol was also added to Patient 9's medication list, which stated that Roxanol was being administered for the symptom of physical pain. P. Ex. 9 at 4; HCFA Ex. 13 at 9. The hospice asserts that, under its written care plan policy, the medication list is considered to be part of the plan of care (P. Ex. 30 at 3); thus, contrary to HCFA's allegation, the reason for using Roxanol is specified in Patient 9's care plan via its inclusion in the medication list.

HCFA attempts to argue that it is not clear whether Roxanol was ordered for Patient 9's pain or coughing. HCFA Br. at 139 - 140. HCFA contends that the team goal and patient/family expectations, as stated in the January 22, 1999 Comfort Care Plan, both relate to pain, but that a registered nurse informed the surveyor that the Roxanol was being given for Patient 9's cough. HCFA Ex. 13 at 15; HCFA Ex. 1 at 24. HCFA argues that the intervention did not contain information pertaining to the scope and frequency of the use of Roxanol in relation to either the pain or coughing. HCFA Br. at 139.

I am not persuaded by HCFA's arguments. Based on the record, I find no basis for HCFA's claim in the SOD that Patient 9's comfort care plan did not give the reason for using Roxanol. The June 1, 1999 nursing note mentions that the patient is experiencing chest area pain due to chronic cough (P. Ex. 9 at 45; HCFA Ex. 13 at 67), and Patient 9's medication list states that Roxanol was for physical pain (P. Ex. 9 at 4; HCFA Ex. 13 at 9). The nursing note, at the top, states "Plan of Care File," and the patient's medication list is, according to the hospice's care plan policy, part of the "working care plan file." See P. Ex. 30 at 3. Thus, both of these documents are part of Patient 9's care plan.

Moreover, I conclude that the order for Roxanol, as written on the medication list (P. Ex. 9 at 4), and in the care plan update (P. Ex. 9 at 9), satisfies the scope and frequency requirements of 42 C.F.R. § 418.58(c). In fact, Ms. Poolsawat admitted that the care plan did indicate the frequency for the administration of Roxanol in that Roxanol was to be given every four hours as needed. Tr. 1689.

Finally, even if HCFA had established that the intervention for Roxanol was inadequately care-planned, there was no showing by HCFA that the care provided to Patient 9 by the hospice was inadequate or that the hospice failed to meet the needs of Patient 9 in accordance with 42 C.F.R. § 418.58(c).

With respect to the intervention for Calmoseptine cream, HCFA contends that Patient 9's care plan failed to identify the affected area on which the cream was to be used, in violation of the scope requirement of 42 C.F.R. § 418.58(c).⁽¹⁸⁾ According to Ms. Poolsawat, the hospice should have stated the specific location of the body where the Calmoseptine cream was to be applied. Tr. 1690.

B. Governing Body. HCFA failed to establish a prima facie case that the hospice was out of compliance with the Governing Body hospice condition of participation. 42 C.F.R. § 418.52.

The hospice's alleged noncompliance with the condition found at 42 C.F.R. § 418.52 (Tag L107)

HCFA alleged that in June 1999, the hospice had a condition-level deficiency in meeting the Governing Body requirements (the hospice's alleged noncompliance with Tag L107). The Governing Body requirements are found in the regulations at 42 C.F.R. § 418.52 (condition of participation -- Governing body).

42 C.F.R. § 418.52. Condition of participation -- Governing body.A hospice must have a governing body that assumes full legal responsibility for determining, implementing and monitoring policies governing the hospice's total operation. The governing body must designate an individual who is responsible for the day to day management of the hospice program. The governing body must also ensure that all services provided are consistent with accepted standards of practice.

HCFA based the condition-level deficiency (Tag L107), on one standard (Tag L108), that requires the following:

A hospice must have a governing body that assumes full legal responsibility for determining, implementing and monitoring policies governing the hospice's total operation.

HCFA Ex. 1 at 1 - 2.

I quote verbatim the SOD allegations to illustrate the absence of even alleged evidence to support the alleged violation of 42 C.F.R. § 418.52. HCFA alleged no specific evidence and, at the hearing, presented no specific evidence, to prove that the hospice failed to have a governing body "that assumes full legal responsibility for determining, implementing and monitoring policies governing the hospice's total operation." Rather, HCFA theorized that the hospice failed to comply with the condition for Plan of Care at 42 C.F.R. § 418.56, and that, consequently, the condition for Governing Body was not met. Tr. 1466; HCFA Br. at 162. HCFA based the alleged condition-level Governing

Body deficiency solely on alleged noncompliance with the Plan of Care requirements for participation,⁽¹⁹⁾ which HCFA failed to prove. See discussion supra.

HCFA's allegation reads as follows in the SOD:

L 107 418.52. CONDITION:

COP: GOVERNING BODY

Condition of participation -- Governing body.

This CONDITION is not met as evidenced by:

The hospice's governing body failed to assume full legal responsibility for determining, implementing and monitoring policies governing the hospice's total operation (L108). The cumulative effect of these systemic practices resulted in the failure of the hospice to deliver statutorily mandated compliance with the provisions for the governing body.

L 108 418.52. STANDARD:

GOVERNING BODY

A hospice must have a governing body that assumes full legal responsibility for determining, implementing and monitoring policies governing the hospice's total operation.

This STANDARD is not met as evidenced by:

Based on the content of this report and interviews with the hospice's administrative staff, the hospice failed to have a governing body that assumed full legal responsibility for implementation and monitoring policies governing the hospice's total operation.

Findings included:

The hospice failed to meet compliance with the following conditions of participation:

418.52 Governing Body

418.58 Plan of Care

These conditions of participation were found to be out of compliance during the second re-survey, conducted from 06/21/99 to 06/23/99.

C. Standards not encompassed by the Plan of Care hospice condition of participation or the Governing Body hospice condition of participation. HCFA failed to establish a prima facie case that any existing deficiencies under Tag L124, Tag L176, Tag L185, or Tag L213, either individually or in combination with any other deficiencies, were of such character as to substantially limit the hospice's capacity to furnish adequate care or adversely affected the health and safety of patients. 42 C.F.R. §§ 488.24(b) and 488.26.

HCFA alleges that there is a standard-level deficiency based on the hospice's alleged noncompliance with Tag L124 - 42 C.F.R. § 418.56(c) (Standard -- Professional management responsibility). This regulation governs arrangements that hospices make for another individual or entity to furnish services for Medicare beneficiaries whose care they manage.

The hospice's alleged noncompliance with the standard found at 42 C.F.R. § 418.56(c) (Tag L124)

HCFA alleged that in June 1999, the hospice had a standard-level deficiency in meeting the Professional Management Responsibility requirements (the hospice's alleged noncompliance with Tag L124). The pertinent Professional Management Responsibility requirement is found in the regulations at 42 C.F.R. § 418.56(c), as follows:

42 C.F.R. § 418.56. Professional management. Subject to the conditions of participation pertaining to services in §§ 418.80 and 418.90, a hospice may arrange for another individual or entity to furnish services to the hospice's patients. If services are provided under arrangement, the hospice must meet the following standards:

. . .

§ 418.56(c) Standard: Professional management responsibility. The hospice retains professional management responsibility for those services and ensures that they are furnished in a safe and effective manner by persons meeting the qualifications of this part, and in accordance with the patient's plan of care and the other requirements of this part.

The SOD, under Tag L124, alleges the violation of 42 C.F.R. § 418.56(c) at the standard level. Before discussing the SOD's alleged findings, I must first address the issue of whether HCFA provided the hospice with adequate notice of its findings relating to this Tag. The SOD alleges failure to retain professional management responsibility for five "hospice patients residing in a nursing home," but the SOD provides information concerning only two patients, Patients 2 and 4. HCFA Ex. 1 at 3 - 7.

The hospice protests HCFA's attempt to inject issues not specifically alleged in the SOD, and has maintained such protest in its hearing request (P. Hearing Req. at 7), at the hearing, and post hearing. Despite the hearing request written notice to HCFA regarding the lack of notice in the SOD, HCFA failed to provide any more specific statement of the alleged deficiencies to the hospice prior to the hearing. HCFA did not provide the hospice with any supplemental notice, of evidence or issues, that would be adequate to permit HCFA to proceed with additional allegations. For the reasons articulated in the hospice's brief (P. Br. at 57 - 60, 66 - 68, 73 - 76, 81 - 82, 85 - 88), HCFA will be confined to its allegations regarding Patients 2 and 4 in attempting to establish its prima facie case, and to only the allegations made in the SOD. The hospice's motion, to have stricken from consideration any evidence submitted by HCFA regarding alleged deficiencies which are not specifically cited in the SOD (Id.), is hereby granted. Specifically, I disregard any evidence in the SOD or from the hearing regarding alleged deficiencies for Patients 1, 3, and 5 under Tag L124. I also disregard any evidence in the SOD or from the hearing regarding alleged deficiencies regarding Patients 2 and 4 under Tag L124 which are not specifically cited in the SOD.

Even the remaining allegations are problematic, for the reasons argued by the hospice. P. Br. at 57 - 92. I agree with the hospice that the allegations that purport to support a finding of deficiency under Tag L124 are vague, contradictory and also difficult to respond to. Further, I agree with the hospice that the regulation [42 C.F.R. § 418.56(c)] does not require "integration" of the plans of care of the two providers, the hospice and the skilled nursing facility. Rather, the regulation focuses on the services being provided to the patients, and the hospice's responsibility to ensure that those services are furnished in a safe and effective manner. I find no evidence that the hospice failed to fulfill that responsibility. See also supra the discussion under Tag L137 concerning Patient 4, regarding "integration," with the caveat that professional management responsibility is separate and distinct from care planning. P. Br. at 63 - 65; see also Tr. 1048 - 1057.

SOD Finding 1 under Tag L124 - Patient

Patient 2's care has already been addressed under Tags L133 and L137. Her comfort management included the discontinuation of monthly laboratory work and blood pressure control with Lopressor, in accordance with the physician's orders. She received range of motion exercises and wore a physician-ordered right hand splint. Her nutrition needs were addressed in part by a gastrostomy tube feeding of Isosource HN with interventions of checking blood sugar daily, with regular insulin coverage, and using Compazine to treat nausea and vomiting. The alleged deficiency here, under Tag L124, is that "the hospice plan of care was not integrated with the nursing home's plan of care." HCFA Ex. 1 at 4. HCFA's theory, as stated in the SOD under Tag L124, that the hospice plan of care must be integrated with the nursing home's plan of care, is not required by the regulation. HCFA presented no evidence that the care and services provided to Patient 2 were other than as required under 42 C.F.R. § 418.56(c), that is, "furnished in a safe and effective manner by persons meeting the qualifications of this part, and in accordance with the patient's plan of care and the other requirements of this part." For the reasons stated in the hospice's brief (P. Br. at 60 - 80), and based upon my conclusions under Tags L133 and L137 concerning Patient 2's care, I find no evidence that the hospice failed to fulfill its professional management responsibility for services to Patient 2 under Tag L124.

SOD Finding 2 under Tag L124 - Patient

Patient 4's care has already been addressed under Tags L133, L136, and L137. She is the nonverbal patient with dementia, dysphagia, and anorexia, whose anxiety manifested by kicking was treated in part by Risperdal, whose pain was addressed in part by the Lortab elixir, and who had range of motion activity. Patient 4 was being fed a pureed diet with no concentrated sweets; eight ounces of high protein nourishment, in-between-meals, three times a day; and a multi-vitamin, vitamin C, and zinc, in order to assist metabolism. The alleged deficiency here, under Tag L124, is that the hospice plan of care was not integrated with the nursing home's plan of care. See HCFA Ex. 1 at 7. HCFA's theory, as stated in the SOD under Tag L124, that the hospice plan of care must be integrated with the nursing home's plan of care, is not required by the regulation. HCFA presented no evidence that the care and services provided to Patient 4 were other than as required under 42 C.F.R. § 418.56(c), that is, "furnished in a safe and effective manner by persons meeting the qualifications of this part, and in accordance with the patient's plan of care and the other requirements of this part." For the reasons stated in the hospice's brief (P. Br. at 60 - 65, 80 - 92), and based upon my conclusions under Tags L133, L136, and L137 concerning Patient 4's care, I find no evidence that the hospice failed to fulfill its professional management responsibility for services to Patient 4 under Tag L124.

The hospice's alleged noncompliance with the standard found at 42 C.F.R. § 418.74 (Tag L176)

TheSOD, under Tag L176, alleges the violation of 42 C.F.R. § 418.74, which states:

In accordance with accepted principles of practice, the hospice must establish and maintain a clinical record for every individual receiving care and services. The record must be complete, promptly and accurately documented, readily accessible and systematically organized to facilitate retrieval.

The SOD contends that, for two of nine patients, "the registered nurse failed to accurately document the patient's condition and the treatment rendered." HCFA Ex. 1 at 24 - 25. Following this allegation is a recitation of the situations concerning two of the hospice patients: Patients 8 and 9. Id. at 25.

SOD Finding (a) under Tag L176 - Patient

With respect to Patient 8, the SOD alleges that the registered nurse had documented conflicting information in a nursing note dated May 25, 1999. HCFA contends "For example, the registered nurse documented in the pain assessment section as [sic] "patient denied pain. Patient stated pain in the right great toe." HCFA Ex. 1 at 25.

I do not find that the May 25, 1999 nursing note contained any conflicting information. For this reason, there is no basis to support a finding that the hospice was out of compliance with the standard under Tag L176.

In the May 25, 1999 nursing note, there is a statement by the registered nurse in the Pain assessment section that the "Pt. [patient] denies pain." This statement is crossed out with a single line and the word "error" is written above it, with the nurse's initials circled beside it. HCFA Ex. 12 at 24. Following this statement, the nurse wrote that the "Pt. states pain in great toe of R [right] foot . . . ." Id. The hospice asserts that the nurse clearly marked the first statement about the patient denying pain as an error, and then correctly indicated in her next statement that the patient was experiencing pain in his toe. As further support of this interpretation of the nurse's written comments, the hospice points to the "Summary" section of the May 25, 1999 nursing notes, which state:

Plan of care reviewed prior to care given. Patient [sic] symptoms reviewed. Pt. denied pain and dyspnea. Then however stated that his toe is achey [sic] and rated it as a mild 3 on 0 - 10 scale. [Dr.'s] office called -- instructed pt. to come in for evaluation of toe . . . .

Id. at 26. The nurse had also noted in the "New Symptoms" section that Patient 8 had a "pink, warm, slightly swollen toe." Id.

Based on the aforementioned documentation, I conclude that the medical record for Patient 8 shows complete and accurate documentation of his toe pain. Moreover, on May 26, 1999, according to a supplemental interdisciplinary note, the hospice nurse wrote that she called the patient at his home. The patient stated that he had seen a physician regarding his toe, and the physician had prescribed Keflex, Lotrimin lotion, and foot soaks. HCFA Ex. 12 at 23. That same day, Patient 8's interdisciplinary care plan was updated to document the interventions for his "inflamed toe." Id. at 40. Thus, it is evident that Patient 8's toe pain was monitored and accurately documented. There is nothing to indicate that the information in the record regarding Patient 8's toe pain was conflicting or inconsistent.

Based upon her testimony, it is apparent that Ms. Poolsawat misread the May 25, 1999 nursing note and did not notice that the nurse had written "error" over her first statement regarding the patient's denial of pain. Ms. Poolsawat did not dispute that the May 25, 1999 nurse's note indicated that the patient had pain in his toe. Tr. 1727. When asked if the nurse "accurately documented that the patient had toe pain on 5/25," Ms. Poolsawat responded, "It appears so." Tr. 1728. She admitted on cross-examination that it was "clear" in looking at the nursing note that the nurse crossed out the phrase "Patient denies pain" and then wrote "Error" and her initials. Tr. 1731. When asked if this was an "appropriate correction of her error," Ms. Poolsawat responded "Yes." Id. She admitted that the nursing notes document that the nurse did call the physician and received instructions from the physician for the patient. Tr. 1727, 1728. Further, Ms. Poolsawat conceded that Patient 8's toe pain was treated by a physician. Tr. 1742.

At the hearing, Ms. Poolsawat appeared to allege other bases not mentioned in the SOD on which to support a finding that Patient 8's medical record contained conflicting information. Tr. 1732, 1734, 1735, 1737. For example, Ms. Poolsawat claimed that Patient 8's care plan was inaccurate and also, that the hospice nurse had written a zero on the left-hand side of the pain section to indicate the level of pain severity, and this was "confusing." See Tr. 1735, 1737, 1741 - 1742. However, in the SOD, Ms. Poolsawat did not allege that Patient 8's care plan contained inaccuracies nor did she mention the zero written in the pain section. I will not consider these new allegations that were raised for the first time at the hearing, of which HCFA had given the hospice no notice.

SOD Finding (b) under Tag L176 - Patient 9

HCFA alleges in the SOD that a review of the nursing notes for Patient 9 from May 20, 1999 to June 14, 1999 "revealed the registered nurse repeatedly documented in the pain assessment section that the patient denied pain and discomfort, but the patient was given Darvocet one to three tablets per 24 hours." HCFA contends further that, during a home visit on June 22, 1999, the registered nurse told the surveyor that Darvocet was given for pain in the patient's stomach. HCFA Ex. 1 at 25.

I do not agree with HCFA that the nursing notes in question contain conflicting information concerning whether or not Patient 9 was experiencing any pain. I do not find that the hospice nurse maintained inaccurate documentation regarding Patient 9's pain.

Patient 9's interdisciplinary care plan for comfort contains an intervention to administer Darvocet for physical pain. HCFA Ex. 13 at 15; See Id. at 7. According to this care plan, the patient's husband was to be taught to assess her pain according to the non-verbal pain scale and to give her Darvocet, as needed, for the pain. The team goal was for the patient's pain to be at a level 3 or lower on the non-verbal pain scale of 0 to 10. HCFA Ex. 13 at 15. Additionally, at each visit, the nurse was instructed to monitor the patient's pain level, evaluate the effectiveness of Darvocet, and monitor the number of doses given. Id.

I find that the fact that Patient 9 was receiving Darvocet for pain is not inconsistent with the other documentation in the nursing notes stating that she was not experiencing any pain at the time of the nurse's visit. As stated above, the team goal for Patient 9 was that her pain would be kept at a level of 3 or below on the nonverbal pain scale. To achieve this team goal, the intervention to administer Darvocet, as needed, was approved by the interdisciplinary team. As instructed, the hospice nurse assessed the effectiveness of the medication at each visit; based on the documentation in the nurse's notes dated May 20, May 21, May 24, and May 28, 1999 (HCFA Ex. 13 at 45, 48, 56, and 62), the patient must have experienced pain above the target level on occasion, since the patient and/or her caregiver reported the doses of Darvocet she took during the day. Further, one would expect the patient's pain to be eliminated if she was receiving doses of Darvocet. Thus, it is entirely likely and logical that Patient 9 would not have any complaints of pain or discomfort at the time of the nurse's visit and, in fact, the aforementioned nursing notes reflect that Patient 9's pain was under control at the time of these visits. When asked about the nurse's May 28, 1999 visit, Ms. Poolsawat conceded on cross-examination that the nurse's notation that the patient is not having any pain would indicate that the patient is not having any pain at the time of the nurse's visit. HCFA Ex. 13 at 62; P. Ex. 9 at 40; Tr. 1759 - 1760. Thus, I conclude that there is no conflicting information in the nursing notes for Patient 9.⁽²⁰⁾

Moreover, the nurse did not complete the pain assessment section in the nursing notes without input. The nurse's written notations concerning the patient's pain level were based on the information she obtained from the patient and/or her caregiver at the time of her visit. For the visit of May 20, 1999, the nurse's notation was "0/10," "Denies any pain discomfort," and "x3 Darvocet in the last 24 [hours]." HCFA Ex. 13 at 45. For the visit of May 21, 1999, the nurse's notation was "0/10," "Denies any c/o [complaint of] pain," and "x2 Darvocet in the last 24 [hours]." Id. at 48. For the visit of May 24, 1999, the nurse's notation was "0/10," "Denies any c/o [complaint of] acute pain discomfort," and "x2 Darvocet in the last 24 [hours]." Id. at 56. For the visit of May 28, 1999, the nurse's notation was "0/10," "Denies any acute pain discomfort," and "x2 Darvocet in the last 24 [hours]." Id. at 62. For the visit of June 1, 1999, the nurse's notation was that the severity of the patient's pain was "2/10" on the non-verbal pain scale, that the location of her pain was the "lung chest area," that the provocation was "cough," that the palliation was "Darvocet," and "x3 Darvocet in the last 24 [hours]." Id. at 65. Patient 9's terminal diagnosis was end stage chronic obstructive pulmonary disease, so her lung and chest area pain from coughing is understandable. Id. at 1.

In addition, Patient 9 had difficulty swallowing and had a gastrostomy tube (PEG tube). Id. at 24. The nurse reported to Ms. Poolsawat that the patient was receiving Darvocet for stomach pain. HCFA Ex. 1 at 25. I do not find the nurse's report to be inconsistent with Patient 9's denials of pain documented in the nursing notes, for the reasons stated above. Based on the evidence, it does not appear that the hospice staff have inaccurately documented Patient 9's pain.

The hospice's alleged noncompliance with the standard found at 42 C.F.R. § 418.74(a)(6) (Tag L185)

In the SOD, under Tag L185, HCFA alleges the violation of 42 C.F.R. § 418.74(a)(6). HCFA Ex. 1 at 25. The regulation states as follows:

42 C.F.R. § 418.74. Condition of participation - Central clinical records. In accordance with accepted principles of practice, the hospice must establish and maintain a clinical record for every individual receiving care and services. The record must be complete, promptly and accurately documented, readily accessible and systematically organized to facilitate retrieval.

(a) Standard: Content. Each clinical record is a comprehensive compilation of information. Entries are made for all services provided. Entries are made and signed by the person providing the services. The record includes all services whether furnished directly or under arrangements made by the hospice. Each individual's record contains -

. . .

(6) Complete documentation of all services and events (including evaluations, treatments, progress notes, etc.).

42 C.F.R. § 418.74(a)(6).

The SOD contends that "Based on clinical record review, the Hospice failed to ensure each individual's clinical record contains progress notes." HCFA Ex. 1 at 26. The SOD then describes a progress note of Patient 8, dated June 4, 1999, and alleges that it "fails to include a summary of all care and services by discipline as required by the hospice policy and training." Id. at 26 - 27.

HCFA's main contention appears to be that the June 4, 1999 progress note for Patient 8 does not contain all the information as required by the hospice internal policy for progress notes. HCFA asserts that the hospice policy states that all progress notes must contain a summary of all care and services by discipline, and that Patient 8's progress note is deficient in this respect. HCFA Ex. 1 at 26 - 27.

The hospice contends in its post-hearing brief that HCFA failed to produce any evidence at the hearing in support of this allegation and therefore, that I should not consider this alleged standard-level deficiency as a basis for the termination. P. Br. at 173.

HCFA does not dispute that it did not offer any evidence at the hearing concerning this deficiency citation. HCFA, nevertheless, has included this tag in its posthearing brief. HCFA Br. at 148 - 150. For this reason, I shall consider whether this alleged deficiency is substantiated based on what is set forth in the SOD.

The SOD refers to a "[h]ospice in-service on 3/16/99 for progress notes," as being the source of the policy in question. However, it has not referred me to any documents in the record which concern this March 16, 1999 inservice. The SOD also sets forth part of the hospice's current progress note policy. HCFA Ex. 1 at 26.

In response, the hospice argues that its policy "does not state that there must be a summary of all care and services by discipline." P. Br. at 173. The hospice contends that the progress note "contained all documentation required by [the hospice's] progress note policy at the time of the June survey, including appropriate documentation of the patient's progress." Id. at 174.

Because I have not been referred to anything in the record concerning the March 16, 1999 hospice inservice for progress notes, I am unable to make a determination as to what policy, if any, resulted from that inservice. What is relevant, however, to my analysis of Patient 8's progress note, is whether it contained the information required under 42 C.F.R. § 418.74(a)(6). The regulation does not list any specific criteria that needs to be contained in a progress note. Subsection (6) of 42 C.F.R. § 418.74(a) simply requires that an individual's clinical record contains "[c]omplete documentation of all services and events (including evaluations, treatments, progress notes, etc.)."

The progress note in question, which is set forth in the SOD, describes Patient 8 as becoming "slowly weaker" since admission, and "experienc[ing] exertional dyspnea after amb. (ambulating) only 10 paces." HCFA Ex. 1 at 26 - 27. The note states further that Patient 8 "increased his use of supplemental oxygen," is "[n]o longer able to accompany his wife in [sic] trips," and that his catheter "requires frequent care." Id. at 27. At the end of the progress note, the hospice staff member wrote that "[b]ased on above documentation, in my opinion, pt. has a life expectancy of < 6 mo. if the disease follows its usual course and therefore remains hospice appropriate." Id. at 27.

As I stated above, 42 C.F.R. § 418.74(a)(6) does not state specifically what information needs to be included in a progress note. The regulation does, however, state that an individual's clinical record "must be complete, promptly and accurately documented, readily accessible and systematically organized to facilitate retrieval." 42 C.F.R. § 418.74. In reviewing Patient 8's progress note, I find that the hospice staff documented pertinent information concerning the patient's condition and eligibility for hospice care. That progress note was only a part of Patient 8's clinical record. The regulation does not require that the summary of all care and services by discipline be contained in every progress note. I conclude that HCFA's allegation of a deficiency under Tag L185, as stated in the SOD, is not contemplated under the regulation, and is thus, without basis.

The hospice's alleged noncompliance with the standard found at 42 C.F.R. § 418.96 (Tag L213)

HCFA alleged in the SOD that in June 1999, the hospice had a standard-level deficiency in meeting the Medical Supplies requirement (the hospice's alleged noncompliance with Tag L213). The Medical Supplies requirement is found in the regulations at 42 C.F.R. § 418.96, as follows:

42 C.F.R. § 418.96. Medical supplies. Medical supplies and appliances including drugs and biologicals, must be provided as needed for the palliation and management of the terminal illness and related conditions.

The SOD alleged a standard-level deficiency based on the hospice's alleged noncompliance with Tag L213 - 42 C.F.R. § 418.96 (Standard -- Medical Supplies). HCFA Ex. 1 at 27 - 31. HCFA maintained that the hospice failed to ensure that medical supplies were provided as needed for the palliation and management of the terminal illness for eight of the nine sampled patients. HCFA Ex. 1 at 27 - 28. Specific examples are cited in the SOD for only six of the referenced patients: Patients 1, 5, 3, 2, 4, and 7. HCFA did not provide notice to the hospice that would be adequate to permit HCFA to proceed with any additional allegations, so HCFA will be confined to its allegations regarding only the six patients, and to only the allegations made in the SOD.

SOD Finding 1 under Tag L213 - Patient 1

The terminal diagnosis which made Patient 1 eligible for hospice is "cerebral degeneration (dementia) except Alzheimer's." HCFA Ex. 4 at 1. The medications that HCFA claims the hospice should pay for, aspirin (aspirin therapy), digoxin (cardiac function), Prilosec (gastric distress), Propulsid (gastric distress), Reglan (gastric distress), regular insulin (Diabetes Mellitus), and NPH insulin (Diabetes Mellitus), were not utilized for the terminal illness or related conditions. Consequently, I find that the hospice was not required to pay for or procure those medications. In managing and directing the patient's overall care, the hospice may ensure that the patient is provided with all medications and medical supplies and appliances that the patient needs, but the same may be paid for or procured from sources other than the hospice. When the hospice chose to include on the medication list, or in the plan of care, medications that were not for the terminal illness or related conditions, that choice did not subject the hospice to paying for or procuring all such acknowledged medications. The hospice was entitled to use the medication list, and the plan of care, to stay aware of a patient's medications, even those not for the terminal illness (that made the patient eligible for hospice) or related conditions. In that way the hospice could better monitor the impact and the interaction of a patient's medications. The hospice is correct in asserting that entering a medication or other medical supply on the medication list or in the plan of care does not require a hospice to pay for or procure a medication utilized for an illness that is not the terminal illness or a related condition. P. Br. at 174 - 182; P. R. Br. at 133 - 139.

SOD Finding 2 under Tag L213 - Patient

The terminal diagnosis which made Patient 5 eligible for hospice is "neoplasm of the large intestine (colon cancer)." HCFA Ex. 9 at 1. The medications that HCFA claims the hospice should pay for are aspirin and Cardura. Neither the aspirin nor the Cardura was utilized for the terminal illness or related conditions, nor did they become related to the terminal illness by being placed on the medication list or in the plan of care. Consequently, I find that the hospice was not required to pay for or rocure those medications. The findings applicable to Patient 1 above apply here as well.

SOD Finding 3 under Tag L213 - Patient 3

The terminal diagnosis which made Patient 3 eligible for hospice is "end stage cerebrovascular disease." HCFA Ex. 7 at 20. The medication that HCFA claims the hospice should pay for is Prevacid. The Prevacid was not utilized for Patient 3's terminal illness or related conditions. The Prevacid does not become related to the terminal illness by being placed on the medication list or in the plan of care. Consequently, I find that the hospice was not required to pay for or procure the Prevacid. The findings applicable to Patient 1 above apply here as well.

SOD Finding 4 under Tag L213 - Patient 2

The terminal diagnosis which made Patient 2 eligible for hospice is "end stage Alzheimer's disease." HCFA Ex. 6 at 1. The medications that HCFA claims the hospice should pay for are Lopressor (hypertension) and Insulin Regular Pork (glucose management). The Lopressor was prescribed for comfort management, which is not related to the terminal illness or related conditions. The insulin was prescribed for Patient 2's blood sugar management, which is not related to the terminal illness or related conditions. Consequently, I find that the hospice was not required to pay for or procure those medications. The findings applicable to Patient 1 above apply here as well.

SOD Finding 5 under Tag L213 - Patient 4

The terminal diagnosis which made Patient 4 eligible for hospice is "cerebral degeneration (dementia) except Alzheimer's." HCFA Ex. 8 at 1. The medications that HCFA claims the hospice should pay for, Insulin NPH Purified (hypoglycemia) and Glucagon (blood glucose management), were not utilized for the terminal illness or related conditions. Neither the Insulin NPH Purified nor the Glucagon became related to the terminal illness by virtue of being included in the patient's overall management. Consequently, I find that the hospice was not required to pay for or procure those medications. The findings applicable to Patient 1 above apply here as well.

SOD Finding 6 under Tag L213 - Patient 7

The wrong patient was cited in the SOD. It was not Patient 6 for whom the items were unavailable; it was Patient 7. P. Br. at 179 - 180. The hospice objected to my considering this allegation at the hearing, and has since moved to strike the evidence I allowed in, over its objection. Tr. 1768 - 1769; P. Br. at 180. At the hearing, I found that the error in the SOD was overcome by the detail contained in the same section of the SOD, where there were also two references to Patient 7. Tr. 1770; HCFA Ex. 1 at 30 - 31. Consequently, I reaffirm my determination that HCFA had provided adequate notice of this patient's identity. The hospice's motion to strike is denied.

The terminal diagnosis which made Patient 7 eligible for hospice is ALS. HCFA Ex. 11 at 1. Patient 7 received hospice care at her home. The medications or supplies that HCFA claims the hospice should pay for, Tucks medicated pads and Preparation H for hemorrhoids, appeared on the medication list, but the hospice was not paying for them. The Tucks and Preparation H were not utilized for the terminal illness or related conditions. Consequently, I find that the hospice was not required to pay for or procure those medications. The findings applicable to Patient 1 above apply here as well.

Additionally, there were medications on the medication list or in the plan of care that were not in Patient 7's home during a home visit: Klonopin for muscle spasm, Sorbitol for constipation, Immodium A-D for diarrhea, acetaminophen for symptoms of fever/chills, and Compazine for symptoms of nausea/dry heaves. Patient 7's medication list had a total of 17 medications to be given as needed for symptom relief. HCFA Ex. 1 at 30. Initially I found it troubling that five "as needed" medications were not available to the patient (i.e., not in the home), regardless of whether the hospice was responsible to pay for them. The evidence persuaded me, however, that the patient had no current need for the items. Patient 7 told the surveyor, Ms. Garces, that those medications had expired and she did not need them. Tr. 1783 - 1784. The hospice could have eliminated the confusion here by making an entry such as "not currently needed" on the medication list, but there was no such documentation. Nevertheless, HCFA failed to prove that the missing medications were "needed for the palliation and management of the terminal illness and related conditions." (emphasis added).

I find that the SOD allegations and HCFA's evidence failed to establish a prima facie case of any medical supplies deficiency under Tag L213. HCFA did not show any failure by the hospice to comply with 42 C.F.R. § 418.96.

D. Termination of Medicare provider agreement to provide hospice care. HCFA failed to establish a prima facie case that HCFA had the authority to terminate, effective August 10, 1999, the hospice's Medicare provider agreement. 42 U.S.C. § 1395cc(b)(2); 42 C.F.R. §§ 488.24, 488.26, 488.28, and 489.53(a)(1).

There is no need for me to consider any evidence from the March 1999 survey because it is irrelevant. The March 1999 survey evidence is irrelevant because HCFA, in its discretion, permitted the hospice the opportunity to establish compliance with the Medicare conditions of participation by the time of the second resurvey (3^rd survey) which was completed on June 23, 1999. HCFA Ex. 2. The June 1999 survey evidence does not show that the hospice failed to establish compliance. Not only does that evidence fail to show non-compliance with any condition of participation, that evidence fails also to show non-compliance with any standard.

The foregoing discussion, in sections V.A., V.B., and V.C., demonstrates that at the time covered by the June 1999 survey, the hospice had no deficiencies that would justify termination. After careful consideration of the evidence, I found no support in the evidence for any of HCFA's alleged deficiencies. I found three insignificant documentation omissions, none of which constituted even a standard-level deficiency. Those three insignificant documentation omissions are discussed under Tag L133, involving Patient 7, Patient 8, and Patient 9. In each case, there was no evidence that the hospice failed to establish and maintain a written plan of care for the patient, and there was no evidence that the hospice failed to provide care in accordance with the plan, as required by 42 C.F.R. § 418.58. The circumstances of Patient 9 were alleged again under Tag L136. Here again, there was no evidence that the hospice failed to assess the patient's needs or to identify and provide services to meet those needs, as required by 42 C.F.R. § 418.58. I found none of the three insignificant documentation omissions was proven to have affected or even to have had the potential to have affected the care and services provided to the patient

Jill S. Clifton

Administrative Law Judge

1. With respect to Tag L133, at the hearing, and in its post-hearing response brief, HCFA discussed only the situations relating to the specific patients identified in the SOD. HCFA did not present any evidence regarding any patients not specifically identified under Tag L133.

2. The nurse visited Patient 7 once a week. Tr. 403.

3. Failing to meet the goal would not necessarily constitute a deficiency, so long as proper and adequate care that met the patient's needs was provided.

4. These nursing notes are dated May 19, 1999, May 27, 1999, June 2, 1999, June 9, 1999, and June 16, 1999, and are the same ones which were the focus of my discussion concerning the monitoring of Patient 7's bowel movements.

5. An appeal of the decision in Libbie Convalescent Center was filed with the DAB, but before an appellate panel of the DAB could review the decision, the appeal was dismissed because the parties settled the case.

6. Throughout this Decision, I use the phrase "nursing home" interchangeably with "skilled nursing facility."

7. Cdr. Liebmann testified that Lopressor is an anti-hypertensive medication to relieve or reduce a person's blood pressure. Tr. 473.

8. In fact, during cross-examination, when asked by the hospice's counsel if any part of this alleged deficiency was based on the fact that the patient was receiving gastrointestinal tube feedings of Isosource, the surveyor replied, "No." Tr. 486 - 487.

9. Risperdal is an anti-psychotic medication. Tr. 520 - 521.

10. In its brief, HCFA argues that the hospice's "charting by exception" argument is irrelevant as to the issue of whether HCFA has come forward with a prima facie case. HCFA Br. at 73.

11. Although HCFA alleges in the SOD that there was a reddened area in Patient 9's perineal area, this appears to be a misstatement of the June 14, 1999 Home Health Aide note, which reads, in part: "reddened area on coccyx, peri area done c soap and water. . . ." HCFA Ex. 13 at 92. There was no testimony that anyone saw a reddened area in Patient 9's perineal area.

12. Respite care is defined in the regulations as "short-term inpatient care provided to the individual only when necessary to relieve the family members or other persons caring for the individual." 42 C.F.R. § 418.204(b)(1); see Tr. 1351 - 1352.

13. In the SOD, the findings under Tag L136 were misnumbered. There were five findings under the tag, two of which were numbered "(2)."

14. According to Cdr. Liebmann, the difference between active and passive ROM is that the individual can assist independently in moving the body part for active ROM, whereas in passive ROM, the individual does not participate and the aide does all of the movement for the individual. Tr. 1151.

15. The request form was approved by the IDG and acts as an order for the provision of home health aide services to the patient.

16. Based on the medical record, Patient 4 suffered from contractures. See HCFA Ex. 8 at 80.

17. See HCFA Ex. 42 at 4, which is an excerpt from the State Operations Manual. See also Tr. 1048 - 1057.

18. Ms. Poolsawat testified that Calmoseptine cream is usually used for skin irritations, such as a skin or diaper rash. Tr. 1690.

19. The Governing body tags, Tags L107 (condition-level) and L108, rely on the Plan of Care allegations, which are Tags L132 (condition-level), L133, L135, L136, and L137. [Tag L135 cites no patient examples and identifies no source of the allegations, so I dismissed Tag L135 based on inadequate notice.]

20. The SOD references the nurses' notes from May 20, 1999 - June 14, 1999, and appears to suggest that the patient was taking Darvocet throughout this period. However, the nurse's notes dated June 4, June 7, June 9, June 11, and June 14, 1999, document that Patient 9 was taking Roxanol for pain and do not mention Darvocet. HCFA Ex. 13 at 71, 77, 80, 86, and 93. In the SOD, HCFA did not mention Patient 9's usage of Roxanol with respect to this alleged deficiency. Thus, I am not considering the aforementioned nursing notes which mention Roxanol in my discussion of this alleged deficiency. I have considered only those nursing notes which documented that Patient 9 was taking Darvocet, since that is what the surveyors have focused on in their allegation.