Date: March 11, 1999
In the Case of:
Kelsey Memorial Hospital,
Petitioner,
- v. -
Health Care Financing Administration.
Docket No. C-96-216
Decision No. CR583
In this decision, I uphold the right of the Health Care Financing Administration (HCFA) to collect the total amount of the civil money penalty (CMP) it had assessed against Petitioner: $21,050. Additionally, I uphold the "Denial of Payment for New Medicare/Medicaid Admissions" (DPNA) remedy also imposed by HCFA against Petitioner.
The dispute before me stems primarily from a CMP totaling $21,050, which was imposed by HCFA following four surveys of Petitioner's long-term care facility.
With great fervor, both parties have zealously litigated the two issues reviewable in this forum: (1) whether HCFA had a basis for imposing the CMP remedy and (2) if such a basis exists, whether the amount of CMP is reasonable. See, e.g., Ruling on Scope of CMP Hearing in Baltic Country Manor v. HCFA, Docket No. C-96-281; Capitol Hill Community Rehabilitation and Special Care Center, DAB CR468 (1997), aff'd, DAB No. 1629 (1997). The parties informed me that, although they have attempted to resolve their differences through settlement negotiations, such efforts have not been successful. Consequently, the evidence now of record consists of:
-- the testimony of 23 witnesses presented during the initial five-day hearing held in Lansing, Michigan, during December 1996 (Transcript pages (Tr.) 1 - 1618);
-- the testimony of 6 witnesses presented during the supplemental hearing held by telephone on January 14, 1998(1) (Supplemental Transcript pages (Supp. Tr.) 398 - 604);
-- one joint exhibit (Jt. Ex. 1) from the parties (Tr. 28);
-- 23 HCFA Exhibits (HCFA Ex. 1 - 23), which were admitted during the initial hearing (Tr. 30);
-- 88 Petitioner Exhibits (P. Ex. 1 - 88) admitted on the first day of the initial hearing (see list at Tr. 4 - 25);
-- 5 Petitioner Exhibits admitted on the second day of the initial hearing (see list at Tr. 402);(2)
-- 66 Petitioner Exhibits admitted on the third day of the initial hearing (see list at Tr. 712 - 17);
-- 5 Petitioner Exhibits admitted on the fourth day of the initial hearing (see list at Tr. 1302);
-- affidavits of Becky Lenz and Elton Perkins (P. Ex. 278, 279), admitted for the supplemental hearing (see Confirmation of Prehearing Conference with Parties (Nov. 26, 1997); Supp. Tr. 401);
-- letter report, with attachments, dated January 14, 1997, provided by Petitioner on my authorization (Tr. 1579);
-- 5 unmarked documents appended by HCFA to its main posthearing brief(3) (HCFA Br.);
-- 2 unmarked documents appended by HCFA to its posthearing reply brief (HCFA Reply);
-- 8 documents titled "exhibits," numbered 1 through 8, appended by Petitioner to its main posthearing brief (P. Br.);
-- 3 documents, each titled "Appendix," appended by Petitioner to its main posthearing brief; and
-- 12 documents, designated "1" through "8," appended to Petitioner's posthearing reply brief (P. Reply).
Additionally, the record before me also contains the parties' extensive written arguments on the evidence, which were submitted to me in the following forms:
-- HCFA's prehearing brief of 10 pages, with attachment;
-- HCFA's main posthearing brief of 125 pages, filed July 8, 1998;
-- Petitioner's main posthearing brief (revised) of 125 pages, filed July 30, 1998;
-- HCFA's posthearing reply brief of 75 pages, filed August 31, 1998; and
-- Petitioner's posthearing reply brief of 75 pages, filed August 31, 1998.
FINDING OF FACT AND CONCLUSION OF LAW (FFCL) 1: It is necessary and proper to resolve only the noncompliance(4) issues relating to the comprehensive assessment requirements of 42 C.F.R. § 483.20(b) (1996)(5) and the comprehensive care plan requirements of 42 C.F.R. § 483.20(d).
Underlying the CMP assessment of $21,050 are the findings from four surveys. The first survey was the standard or annual survey (42 C.F.R. § 488.305), and the other three were "resurveys" to ascertain whether Petitioner had attained compliance (42 C.F.R. § 488.308(c)(2)). All four surveys were performed for HCFA by employees of the Michigan State surveying agency. The four surveys took place between September 1995 and March 1996. The findings of the first survey were revised by the surveyors during October or November 1995, pursuant to guidelines issued by HCFA. HCFA Ex. 2.
For the first survey, the surveyors issued 15 noncompliance findings (each of which corresponded to a federal regulatory requirement), after they used 11 residents as samples and made changes in their findings during October or November 1996. HCFA Ex. 3. HCFA adopted those 15 noncompliance findings.
For the second survey, the surveyors issued 6 noncompliance findings, after they used 11 residents as samples.(6) HCFA Ex. 6. HCFA adopted all 6 noncompliance findings.
For the third survey, the surveyors issued 4 noncompliance findings, after they used 14 residents as samples. HCFA Ex. 9. HCFA adopted those 4 noncompliance findings.
For the fourth survey, the surveyors issued 2 noncompliance findings, after they used 5 residents as samples. HCFA Ex. 11. HCFA adopted those 2 noncompliance findings.
The amount of evidence and arguments presented by the parties reflect their disagreement over all 27 of the noncompliance determinations. Underlying these disagreements are matters ranging from Petitioner's concerns for the effects of "surveyor intimidation" (P. Br., 101 - 103), to the proper use of interpretive guidelines contained in the State Operations Manual (P. Br., 73 - 77).(7) Additionally, the parties have been at odds over virtually every legal or procedural aspect of this case.
I do not find it necessary to resolve every dispute between the parties. I need not even find noncompliance in all 27 areas before concluding that HCFA had a basis to impose a CMP. So long as there is noncompliance with one program participation requirement, HCFA may impose a CMP as a remedy. 42 C.F.R. § 488.430. Moreover, HCFA did not set the CMP rate in controversy by factoring in multiple noncompliance findings from each survey.
Having especially considered the content of the four survey reports and the evidence concerning the CMP amount, I find it appropriate to limit my noncompliance analysis to the issues of whether Petitioner was out of compliance with the comprehensive assessment requirements of 42 C.F.R. § 483.20(b) and the care plan requirements of 42 C.F.R. § 483.20(d). HCFA found Petitioner out of compliance with the comprehensive assessment requirements during all four surveys. As discussed below, HCFA also used the scope and severity level of Petitioner's noncompliance with this requirement to establish the CMP rate.
HCFA found Petitioner out of compliance with the care plan requirements in only the first three surveys. HCFA did not rely on this area of noncompliance to set the CMP rate. Nevertheless, I will address the issue of Petitioner's noncompliance with 42 C.F.R. § 483.20(d) because the care plan requirements interface with the comprehensive assessment requirements. The two interrelated sets of requirements assume practical significance when considered together.
FFCL 2: The assessment requirements of 42 C.F.R. § 483.20(b) interface with the care plan requirements of 42 C.F.R. § 483.20(d) for the protection of all residents, to ensure that they will be furnished services to attain or maintain their highest practicable level of well-being through the long-term care facility's use of the comprehensive, accurate, standardized, and reproducible processes specified by regulations.
Both subsections (b) and (d) of 42 C.F.R. § 483.20 are prefaced by the following general requirements:
[t]he facility must conduct initially and periodically a comprehensive, accurate, standardized, reproducible assessment of each resident's functional capacity.
42 C.F.R. § 483.20.
Subsection (b) of 42 C.F.R. § 483.20 specifies the forms and criteria which must be used in assessing each resident's functional capacity:
(1) [a] facility must make a comprehensive assessment of a resident's needs, which--
(i) [i]s based on a uniform data set specified by the Secretary and uses an instrument that is specified by the State and approved by the Secretary; and
(ii) [d]escribes the resident's capacity to perform daily life functions and significant impairments in functional capacity.
(2) The comprehensive assessment must include at least the following information:
(i) Medically defined conditions and prior medical history;
(ii) Medical status measurements;
(iii) Physical and mental functional status;
(iv) Sensory and physical impairments;
(v) Nutritional status and requirements;
(vi) Special treatments or procedures;
(vii) Mental and psychosocial status;
(viii) Discharge potential;
(ix) Dental condition;
(x) Activities potential;
(xi) Rehabilitation potential;
(xii) Cognitive status; and
(xiii) Drug therapy.
42 C.F.R. § 483.20(b)(emphasis added).
The standardized Minimum Data Set (MDS) form is an approved instrument containing the requisite uniform data sets which must be used by Medicare certified long-term facilities in the assessment process. 42 C.F.R. § 483.20(b)(1)(i). As shown by the evidence (e.g., P. Ex. 1) and as emphasized by Petitioner (P. Br., 7), the various sections to be completed on the MDS form reflect the various categories of information which must be evaluated pursuant to 42 C.F.R. § 483.20(b)(2). Thus, the MDS form represents the foundation on which the comprehensive assessment process is built.
The parties do not disagree that, in order to begin the assessment process for each resident, a facility should complete all sections of the MDS form by marking, or placing the appropriate numerical value in, the applicable boxes. Tr. 132. Next, the facility should determine whether particular answers placed on the MDS form should "trigger" further evaluations of the resident's functional limitations or potentials by use of the "Resident Assessment Protocol" (RAP) process. P. Br., 8; Tr. 133; P. Ex. 45 at 5. A manual published by HCFA to accompany the MDS form contains a listing of the values and response which constitute "triggers," as well as guidelines concerning the additional information or responses to be analyzed should such "triggers" exist. Tr. 133; see also, e.g., P. Ex. 45 at 5. Resident-specific information resulting from the RAP process may be placed on any form chosen by the facility. Tr. 133.
Thus, the technical aspect of producing a written comprehensive assessment entails (at the very minimum) completing a MDS form, identifying the "triggers" indicated on the completed MDS form, and performing the RAP process if necessary.
The written assessment completed by a facility must also be "comprehensive," "accurate," "reproducible," and focused on the resident's functional capacity. 42 C.F.R. § 483.20. A facility's compliance with these requirements is important to the resident's health and well-being because, "[t]he results of the assessment are used to develop, review, and revise the residents' comprehensive plan of care, under paragraph (d) of this section." 42 C.F.R. § 483.20(b)(6).
Paragraph (d) states:
(1) [t]he facility must develop a comprehensive care plan for each resident that includes measurable objectives and timetables to meet a resident's medical, nursing, and mental and psychosocial needs that are identified in the comprehensive assessment. The care plan must describer [sic] the following--
(i) The services that are to be furnished to attain or maintain the resident's highest practicable physical, mental, and psychosocial well-being as required under § 483.25; and
(ii) Any services that would otherwise be required under § 483.25[(8)]but not provided due to the resident's exercise of rights under § 483.10, including the right to refuse treatment under § 483.10(b)(4).
(2) A comprehensive care plan must be--
(i) Developed within 7 days after completion of the comprehensive assessment;
(ii) Prepared by an interdisciplinary team
. . .; and
(iii) Periodically reviewed and revised by a team of qualified persons after each assessment.
(3) The services provided or arranged by the facility must--
(i) Meet professional standards of quality; and
(ii) Be provided by qualified persons in accordance with each resident's written plan of care.
42 C.F.R. § 483.20(d).
By their very terms, all of the above-quoted regulatory requirements interface for the benefit of residents. If, for example, the written assessment of the resident's needs and functional capabilities was inaccurate, incomplete, or not capable of being verified by objective means (i.e., not reproducible), the facility would not be able to complete a care plan setting forth appropriate timetables, measurable objectives that are realistic, or optimal services to meet the resident's needs and help the resident attain and maintain the highest practical level of well-being.
FFCL 3: I reject Petitioner's general arguments that HCFA's noncompliance determinations under 42 C.F.R. § 483.20(b) and § 483.20(d) should be set aside on grounds that:
A. HCFA did not have a legal basis for drawing adverse conclusions when information was omitted from those documents specifically titled raps or RAPS summary sheets;
B. there existed no potential for more than minimal harm to any residents, since the staff was familiar with each resident's medical condition and needs;
C. the residents' conditions were being properly managed or monitored by physicians; and
D. only isolated and minor documentation errors had occurred.
In its posthearing briefs, Petitioner has made several arguments which appear to be responsive to many of the criticisms lodged by HCFA under 42 C.F.R. §§ 483.20(b) and (d). Even though Petitioner has raised some of those arguments in discussing particular residents, these arguments appear to stem also from Petitioner's general interpretations of the law. Therefore, rather than discussing them in depth repeatedly when evaluating the disputed facts concerning each individual resident, I will treat the following arguments by Petitioner as general affirmative defenses and address them as a group.
A. Rejection of Petitioner's arguments concerning the adverse inferences drawn by HCFA after reviewing certain documents titled as RAPS or RAPS summary sheets
Petitioner notes that only the use of the MDS form is required by law and one MDS form had been filled out for each of its residents. Since there exists no legal requirement for placing all additional assessment information on specific pieces of paper,(9) Petitioner contends that HCFA had no legal basis for finding Petitioner out of compliance with 42 C.F.R. § 483.20(b) on the basis of information omitted from those documents which Petitioner had specifically titled as RAPS or RAPS summary sheets. P. Br., 8 - 9 (citing Surveyor Perry's testimony); Tr. 99 - 101. Petitioner argued that its assessments of residents should have been found comprehensive because additional pieces of assessment information appeared in other types of records as well.
I do not find the reasoning underlying Petitioner's affirmative defense to be fully consistent with the intent or mandate of the regulations. Neither the surveyors nor HCFA had erred as a matter of law in having given weight to what was contained or not contained in those documents denoted by Petitioner as its RAPS summaries.(10)
According to the plain language of 42 C.F.R. § 483.20(b), Petitioner's use of the mandatory MDS form does not establish that all of the assessment requirements have been met. Petitioner's use of the MDS form shows only that a written assessment was commenced in accordance with a "standardized" format. The use of that particular form does not establish that Petitioner had placed accurate, complete, or reproducible assessment information on it, or that the necessary and appropriate follow-up evaluations were done.
The testimony elicited by HCFA, which is consistent with the requirements of 42 C.F.R. § 483.20, confirms that a facility should not be using the assessment process to merely catalog diagnoses or list available information on various pieces of paper. The comprehensive assessment document(s) should include the causes and severity of the resident's condition to enable the preparation of an appropriate care plan. See Tr. 242. Beyond listing facts of significance for each resident, the assessment document(s) should exhibit an analysis and understanding of those facts in terms of their potential causes, associated symptoms, likely results, and what interventions are needed. See Tr. 684, 834 - 35.
Even though the regulation does not specify that RAPS assessments must be placed on only those documents denoted as such, Petitioner had forms of its own design which were specifically titled as its "RAPS Summary Sheets." E.g., P. Ex. 95. Petitioner does not claim that all of its RAPS summary sheets contain incomplete RAPS information. (Its arguments suggest that only some of its "RAPS Summary Sheets" contained incomplete information.) Since all resident assessments must be comprehensive and reproducible, one would expect to see all that Petitioner considered to be RAPS assessment data at the time of their creation to be entered on documents denoted as such by Petitioner. Otherwise, the discrepancies would logically beg the question of whether the assessment process had been performed in accordance with the regulatory requirements and objectives.
B. Rejection of Petitioner's arguments that there existed no risk for more than minimal harm to its residents because its staff was familiar with each resident's condition
Petitioner contends that, even if there were defects or omissions in its documents, there existed no potential for more than minimal harm to residents since its staff was familiar with each resident's medical condition and needs. Petitioner emphasized that it is a small rural facility with few "new hires." P. Reply, 11. It reasons that its small staff, who has long tenure, would not likely deliver inappropriate care or place its residents at risk for more than minimal harm. See, e.g., P. Reply, 11 - 12.
Again, I do not find this line of defense to be fully consistent with the relevant legal framework. I do not accept the proposition that the size or tenure of a facility's staff has material bearing on the issue of whether it is out of compliance with the "comprehensive assessments" and "comprehensive care plans" requirements of 42 C.F.R. § 483.20. Neither Congress nor the Secretary had excused small facilities with a more stable staff from complying with the resident assessment and care plan requirements.(11)
The regulatory scheme makes clear that a Medicare certified facility like Petitioner is obligated to do more than render custodial care or keep its residents safe from serious injury or unnecessary death. When a facility deviates significantly from the mandatory assessment and care planning requirements, such deviations will very likely inhibit the provision of services which will enable the residents to attain or maintain their highest practical level of well-being. In such a situation, the consequences to residents cannot be considered merely de minimis or inconsequential when the regulations, by their very terms, entitle residents to receive services for attaining or maintaining their highest practical level of well-being.
The potential for more readily discernible harm to residents also cannot be ruled out, even if Petitioner's staff has been as stable and knowledgeable as alleged. The realities are that some residents are transferred to other facilities, care-givers change jobs from time to time, and memories of past services tend to fade over time. These are some of the reasons why 42 C.F.R. § 483.20 requires that resident assessments and the resultant care plans be done in writing, and be comprehensive, accurate, standardized, and reproducible.
C. Rejection of Petitioner's reliance on the physicians' management or monitoring of residents' condition
In response to several of HCFA's allegations concerning inadequacies in the assessment process, Petitioner has used the testimony of physicians to indicate that the residents' care was being properly managed or monitored. However, as a matter of law, Petitioner cannot be excused from its obligations to its residents on the basis of what a physician was doing. The issue was addressed thus in the preamble of the regulations:
Comment: An additional factor that commenters believe surveyors should take into consideration when determining deficiencies is whether the noncompliance occurred because the facility was following a physician's orders.
Response: We cannot allow this to be considered in the deficiency determination. The facility is accountable for providing to the resident the medical services to which he or she is entitled as a Medicare or Medicaid beneficiary . . . The statute specifically contemplates a relationship between a facility and either the Secretary or the State . . . in which the facility, in exchange for certification and payments for the care of program beneficiaries, commits to provide care in a manner consistent with statutory requirements.
59 Fed. Reg. 56,227 (1994).
D. Rejection of Petitioner's arguments that isolated and minor documentation errors had occurred
Petitioner also seeks to defend itself by contending that the defects in its assessment and care plan documents reflect mere technical oversights or minor record keeping problems, which should not have resulted in any finding of noncompliance. It argues, for example, that an omission considered significant by HCFA "represents nothing more than a documentation issue" unrelated to the quality of care received by residents. P. Reply, 12. It suggests that HCFA is misusing the relevant statutes and regulations to "intimidate and/or fine facilities for a documentation issue." P. Reply, 12.
I find the foregoing line of defense to be inappropriate to the law as well as the facts in this case.
Petitioner is wrong in suggesting that the assessment and care plan requirements are unrelated to the quality of care delivered to residents. The regulation titled "Quality of care" specifies that each resident must receive, and the facility must provide, services "in accordance with the comprehensive assessment and plan of care." 42 C.F.R. § 483.25. The care plan should be developed from a comprehensive written assessment of the resident. 42 C.F.R. § 483.20(b)(6).
As my discussions below will show, Petitioner's resident assessment and care planning records were not accurate, complete, reproducible, or reliable during the four surveys. The frequency and repetition of certain omissions and defects suggest rather strongly that they stemmed from Petitioner's lack of understanding of the relevant regulatory purposes. The facts of record do not adequately support Petitioner's intimation that its staff had inadvertently failed to record certain information they knew to be significant on a few occasions.
FFCL 4: As shown by the evidence concerning RESIDENTS 1, 4, 5, and 9 of Survey 1, Petitioner was not in substantial compliance with the requirements of 42 C.F.R. § 483.20(b) during the first survey.
During the mandatory annual survey, conducted during September 1995, surveyors reviewed the care Petitioner had provided to 11 of its residents. HCFA Ex. 3.(12) Petitioner had a total of 40 residents at the time of that survey. Id. at 1.
According to the report prepared by the surveyors for the September 1995 survey, Petitioner's noncompliance with the requirements of 42 C.F.R. § 483.20(b) (also denoted as Tag F-272)(13) appeared in the records of all 11 residents. HCFA Ex. 3 at 14. However, to prove Petitioner's noncompliance with the assessment requirements of 42 C.F.R. § 483.20(b) in the proceedings before me, HCFA relies primarily on the deficiencies found in the records of four residents: RESIDENTS 1, 4, 5, and 9. HCFA Br., 8 - 14.
A. RESIDENT 1 of First Survey
1. HCFA's evidence and arguments for RESIDENT 1
In criticizing Petitioner's assessment of RESIDENT 1, an insulin- dependent diabetic, HCFA relies on a surveyor's conclusions that Petitioner did not properly evaluate the inadequacy of this resident's oral diet to sustain her life and that Petitioner failed to address how a directive for "no tube feeding" affected this life-threatening dietary problem. HCFA Br., 8; Tr. 134 - 36. The surveyor noted inconsistencies in the MDS form that was completed by Petitioner on September 19, 1995, due to a change in this resident's condition after she was admitted on June 5, 1995.
First, Petitioner indicated on the MDS form that this resident was 5 feet 1 inch tall and weighed only 85 pounds at the time of the assessment--having lost either 5 percent of her total body weight in the previous 30 days or 10 percent of her total body weight in the previous 180 days. P. Ex. 1 at 4; Tr. 135 - 36. This extent of weight loss constituted a significant change in her physical status and thereby obligated Petitioner to reassess her needs promptly. 42 C.F.R. § 483.20(b)(4)(iv). On the MDS form itself, Petitioner had acknowledged that the September 19, 1995 assessment was being done due to this resident's "[s]ignificant change in status." P. Ex. 1 at 1 (Sect. A, 6).
Yet, having apparently recognized that this resident was in dire straits due to her severe and rapid weight loss, Petitioner did not indicate on the MDS form that she may need a feeding tube or have the use of a feeding tube assessed. On the MDS form, there is a section titled "Nutritional Approaches," within which Petitioner could have placed a check mark next to "[f]eeding tube." P. Ex. 1 at 3 (Sect. L, 4). Petitioner did not do so. Id.
Nor did Petitioner place on the MDS form any information which would preclude consideration of a feeding tube for increasing the dietary intake of this resident. For example, in the "advance directives" section of that MDS form, Petitioner did not indicate that there existed any "feeding restrictions" advance directive. Tr. 135; P. Ex. 1 at 1 (Sect. A, 9).
The surveyor's observations and explanations lead reasonably to the conclusion that either Petitioner had placed inaccurate information on the MDS form for this resident or Petitioner had failed to perform the assessment process comprehensively for her. As explained previously, placing the correct, objectively verifiable, and complete answers on the MDS form should be the first step taken in the comprehensive assessment process. Petitioner acknowledges in its brief that such answers should form the basis for determining whether more detailed evaluations should be commenced in certain areas pursuant to the RAP process. Here, RESIDENT 1 was losing a significant amount of weight, and the MDS form completed by Petitioner indicates that she was dehydrated, not consuming all or nearly all of the fluids provided to her during the previous three days, and was leaving 25 percent or more of her food uneaten during most meals. P. Ex. 1 at 3 (Sect. L, 3). On these facts, no reasonable person can seriously doubt that Petitioner's omissions concerning the potential use of a feeding tube had placed this resident at risk for sustaining more than minimum harm.(14)
Therefore, I find that HCFA has made a prima facie showing that Petitioner was out of substantial compliance with 42 C.F.R. § 483.20(b).
2. Petitioner's evidence and arguments for RESIDENT 1
To rebut HCFA's prima facie showing of noncompliance, Petitioner's position is that, notwithstanding any alleged deficiency which may be reflected by the MDS form it had completed on September 19, 1995 for RESIDENT 1, the necessary additional evaluations for this resident were in fact "triggered" and performed, as evidenced by the RAP summary sheet, other records maintained by Petitioner, and its staff members' familiarity with this resident's condition and needs. See, e.g., P. Br., 8 - 9.
However, the regulation at issue requires written assessments which are not only complete, accurate, standardized, but also reproducible. Therefore, the requirements of 42 C.F.R. § 483.20(b) cannot be satisfied by having physicians, nurses, and aides maintain allegedly material assessment information in their minds.
Moreover, the RAP summary sheet and other records relied upon by Petitioner fail to establish that this resident's dietary needs were assessed accurately or completely for the purpose of enabling the resident to attain or maintain her highest level of well-being.
According to the dietician's records, this resident's ideal body weight should be 105 pounds. P. Ex. 4 at 1. Around mid-July 1995, this resident weighed about 106 pounds. P. Ex. 5 at 8. By August 30, 1995, she weighed only 86 pounds. Id. The dietician was aware of this decrease. P. Ex. 2 at 5. Yet, in assessing this rapid and significant weight loss on September 12, 1995, the dietician made no essential changes in her previous recommendations dated July 12, 1995. Id. at 2; P. Ex. 4. As a result, Petitioner continued to give this resident a diet of 1800 calories per day and continued to encourage her to consume more proteins and fluids. Id. Therefore, the best that can be said for these dietary assessments is that the dietician generated some documents in September 1995.
I have found no credible or legally valid support for Petitioner's contention that its omissions wewe due to the existence of an "advance directive,"(15) which precluded the use of a feeding tube for RESIDENT 1. No such advance directive is in evidence. To imply the existence of an advance directive proscribing the use of a feeding tube in September 1995, Petitioner uses information derived from multiple hearsay statements.
In the record is a copy of a "Durable Power of Attorney" dated March 11, 1993, wherein RESIDENT 1 had authorized one of her sons--(16)
to give such consent and authorization for my medical and surgical treatment as may be necessary and advisable in [his] discretion upon consultation with my attending physicians.
P. Ex. 11 at 2 (emphasis added). The record contains also a copy of a printed coding sheet prepared on March 31, 1993, during one of this resident's several prior admissions to Petitioner's facility. On March 31, 1993, some unidentified person(17) had signed the March 31, 1993 coding form, after marking the box to indicate that RESIDENT 1 was to receive--
[n]o resuscitation: No closed chest cardiac massage, no defibrillation and no intubation/ventilation. Patient will receive comfort measures only.
P. Ex. 8. A member of Petitioner's staff then wrote on this March 31, 1993 form: "See Families [sic] wishes re Tubes on 9-11-94." Id. (The writing is undated and unsigned.) The family's "wishes re Tubes on 9-11-94" apparently refers to the fact that, during another admission of this resident, an unidentified member of Petitioner's nursing staff wrote on September 11, 1994:
[f]amily decided to have nothing done--tubes, W-BS etc. Family & sons all here at this time & discussed situation & reached decision to do nothing at this time.
P. Ex. 7 at 1 (emphasis added).
Then, during the resident's admission in June 1995, one of Petitioner's social workers wrote:
family did state that they do not want any life support measure or CPR, they left before Code Sheet was signed, but had stated wishes to me.
P. Ex. 10 at 4. Petitioner's Director of Nursing wrote the following words on the RAP summary sheet:
[f]amily remains united in decision that only comfort & dignity be given, no tubes. . . .
P. Ex. 2 at 6. Her writing is dated September 19, 1995, two days before the survey.
The foregoing evidence does not suffice as, nor does it establish the existence of, any legally valid "advance directive" proscribing the use of a feeding tube to increase dietary intake when Petitioner was assessing RESIDENT 1 for her changed condition during September 1995, after she had been admitted in June 1995.
Petitioner and like Medicare certified facilities must maintain policies on "advance directives" in conformity with the requirements of 42 C.F.R. Part 498, Subpart I. 42 C.F.R. § 483.10(b)(7)(iv)(as incorporated by 42 C.F.R. §§ 483.20(d)(ii), 483.10(b)(4)). Here, Petitioner has provided no copy of any policy to explain its cavalier, and possibly unlawful, withholding of a service to RESIDENT 1. Whether or not Petitioner has a policy on the issue, an "advance directive" in this case can only mean:
a written instruction, such as a living will or durable power of attorney for health care, recognized under State law (whether statutory or as recognized by the courts of the State), relating to the provision of health care when the individual is incapacitated.
42 C.F.R. § 489.100 (emphasis added).
The social worker's statement dated June 1995 establishes that not even a coding sheet had been signed by any family member or the resident for the current admission. Petitioner has not alleged or shown that Michigan State law would recognize the care-giver's summary of the family's collective agreement on September 11, 1994 "to do nothing at this time" as a legally binding written instruction for Petitioner to refrain from using a feeding tube to treat RESIDENT 1's significantly deteriorated health condition over a year later, in September 1995.
Moreover, this resident gave her power of attorney to only one son--not to the collective will of her family. P. Ex. 11. This resident's "Durable Power of Attorney" provides for only the designated son to make health care decisions in consultation with her attending physicians. Id. Petitioner's evidence does not even identify which family members were involved in making the alleged decisions to prohibit the use of a feeding tube in September 1994, much less whether the attending physician had been consulted. Certainly nothing provided by Petitioner indicates that the staff members who so readily accepted the "do nothing at this time" as gospel etched in stone for this resident were even aware of the limitations created by the Durable Power of Attorney.
These problems exist also for Petitioner's use of its Director of Nursing's summary statement of September 19, 1995 that "[f]amily remains united in decision that only comfort & dignity be given, no tubes . . . see code sheet" P. Ex. 2 at 6.(18) Due to the problems already noted, this statement by Petitioner's employee does not constitute a legally valid or binding instruction to Petitioner. The absence of any signed coding form for the current admission or since her earlier admission on March 31, 1993 (indicating "[n]o resuscitation . . . ."), begs the question of whether Petitioner had developed this "advance directive" rationale for the sole purpose of defending against the survey findings. Even if the family had left before signing a coding form during the current admission, as indicated by the note of a social worker dated June 1995 (P. Ex. 10 at 4), there was certainly enough time for Petitioner to obtain completed and signed documents from a legally authorized individual during the following months.
Additionally, there are other factual problems stemming also from Petitioner's reliance on the March 1993 coding sheet stating, "[n]o resuscitation: . . . comfort measures only." P. Ex. 8; see P. Ex. 10 at 4. In September 1995, RESIDENT 1's condition was not such that she required resuscitation to remain alive, or the use of tubes in any resuscitative effort. Petitioner's evidence does not establish a basis for believing that, even if there were an advance directive for "no resuscitation" in place, Petitioner truly thought in September 1995 that only comfort care was appropriate for this resident.
Petitioner placed into evidence the notes of Dr. London, its Medical Director and this resident's attending physician. P. Ex. 5. Dr. London's records reflect his very active treatment of this resident from June 1995 until the end of September 1995. Id. He was actively and repeatedly adjusting this resident's medication levels in order to bring her diabetes under control. Id. He was concerned about the "unstable condition" caused by her continuing weight losses (id. at 12) and about the "excessively and dangerously low" blood sugar levels caused by her inadequately controlled diabetes (id. at 10). Because RESIDENT 1 was an insulin-dependent diabetic, the amount of her nutritional intake was affecting her ability to regulate her blood sugar level. P. Reply, 6.
Given these contemporaneous and active intervention measures by Dr. London, Petitioner could not have reasonably concluded that RESIDENT 1's health had deteriorated to the point where she would not have been able to remain alive except if tubes were inserted for the purpose of resuscitating her. This resident's health in September 1995, although very poor, had not progressed to the point where any "no resuscitation . . . comfort care only" directive would have become applicable. Obviously, Dr. London was not providing her with comfort care only at that time. In September 1995, this resident needed to be assessed by Petitioner for the use of a feeding tube in order to increase her dietary intake and help control her diabetes, which Dr. London was endeavoring to do by his active delivery of medical services to her. In September 1995, Petitioner was not assessing this resident for whether she needed to be resuscitated with the use of tubes. Even if the March 1993 coding sheet on "[n]o resuscitation . . . comfort care only" could be construed as continuing in force through every subsequent admission of this resident by Petitioner, the proscription of the coding sheet was not applicable to the situation in September 1995. Therefore, for these additional reasons as well, I find Petitioner's "advance directive" defense to be contrived.
I am aware that Petitioner has placed into evidence its "interdisciplinary note" dated October 20, 1995, which states that this resident's son, Dale, had prohibited Petitioner from using a feeding tube to improve her nutritional status. P. Ex. 12. However, I give this information no weight. Nor do I find this evidence material to the issue of Petitioner's compliance during the survey of September 1995. The "interdisciplinary note" was generated well after the conclusion of the September survey. In none of the three subsequent surveys was RESIDENT 1's situation used to find Petitioner out of compliance with program requirements. Additionally, the fact remains that Petitioner has failed to establish the existence of any legally valid advance directive when Petitioner performed the assessment in mid-September 1995. Additionally, Petitioner has failed to show that, even if a "no resuscitation" instruction had been given by a legally authorized individual and in accordance with the requirements of Michigan State law, such an instruction was not applicable to the state of RESIDENT 1's health in September 1995. It goes without saying that a "no resuscitation" order cannot be used by nursing homes to withhold appropriate services from residents who are not moribund--especially when, as in this case, those services could improve their health.
In sum, Petitioner has not rebutted HCFA's prima facie case.
B. RESIDENT 4 of First Survey
1. HCFA's evidence and arguments for RESIDENT 4
HCFA cited the testimony given by a surveyor, who was a registered dietician, concerning the assessments which should have been done when RESIDENT 4's laboratory results of May 26, 1995 indicated a low albumin level of 2.9 mg. HCFA Br., 10. (Both parties agree that a normal albumin level is between 3.5 mg and 5.5 mg. Tr. 1138; HCFA Br., 10.) This registered dietician surveyor explained that the low albumin level was indicative of a low protein level; for that reason, Petitioner should have made a comprehensive assessment of this resident's need to increase her protein intake and to replenish her visceral protein stores. See HCFA Br., 10.
HCFA pointed out that this resident's low albumin level of 2.9 was recorded on the nutritional assessment done on September 11, 1995. HCFA Br., 10 (citing P. Ex. 43 at 2). However, Petitioner's dietician proceeded to draw the incorrect conclusion that even though this resident's albumin level had decreased, she was receiving 100 percent of her protein needs. Id. at 10. Consequently, the RAP summary sheet completed by Petitioner on the same day as the nutritional assessment also contains the incorrect assessment that, through this resident's existing diet, she was receiving 100 percent of her protein needs. HCFA Br., 10 (citing P. Ex. 41).
Based on the foregoing evidence, I conclude that HCFA has made a prima facie showing that in assessing RESIDENT 4's needs, Petitioner has failed to comply substantially with the requirements of 42 C.F.R. § 483.20(d). Petitioner made an inaccurate assessment of her need for more protein in her diet because its staff failed to recognize that a below normal albumin level reading cannot be interpreted as meaning that the individual is receiving 100 percent of her protein needs. A below normal albumin level means the very opposite of what Petitioner has indicated on its written assessments of this resident.
Petitioner's apparent inability to interpret low albumin levels correctly in assessing whether its residents are in need of more protein in their diet can lead reasonably to the conclusion that the health and well-being of RESIDENT 4 and other residents with low albumin level readings have been placed at risk for more than minimum harm.
2. Petitioner's evidence and arguments for RESIDENT 4
Petitioner's defense appears to be that it had acted properly and caused no harm to RESIDENT 4 by having kept her on her existing diet. During the hearing, Petitioner introduced expert testimony to show that this resident tended to gain weight because she was bed-ridden and using a feeding tube due to her multiple sclerosis. However, she was not suffering from malnutrition because she was at her ideal weight, and she was continued on the same diet because her family did not want her to gain additional weight.(19) See, e.g., Tr. 962, 1114, 1241 - 42.
In its brief, Petitioner especially disputed the surveyor's opinion that malnutrition was indicated by a low albumin level alone. P. Reply, 8. Additionally, Petitioner underscored the testimony provided by Dr. London, its Medical Director and this resident's attending physician, concerning the life-threatening dangers which could result if more weight were to be gained by this resident who has an enlarged heart (cardiomegaly) and has suffered congestive heart failure in the past. Id.
Petitioner's defense misses the mark. The regulation required Petitioner to use correct and complete information in the assessment process in order to decide what treatments or interventions, if any, would be appropriate. The assessment problem shown by Petitioner's records concerning RESIDENT 4 is its failure to recognize that it is wrong to equate a below-normal albumin level with the conclusion that the resident's diet was meeting 100% of her protein needs. The incorrect information Petitioner's staff wrote down repeatedly in the assessment process was that 100 percent of RESIDENT 4's "protein needs" was being met.
It may well be that this resident should not have had her existing diet altered because the consumption of other foods may cause her to gain weight and thereby suffer health consequences which may be more detrimental than those arising protein deficiencies. However, this conclusion means only that this resident's diet should remain unchanged due to other considerations notwithstanding her protein needs. A decision to maintain her existing diet to avoid weight gain does not signify that the existing diet had been meeting 100 percent of her protein needs, as indicated by Petitioner's assessment records.
Even Petitioner's evidence establishing that this resident was not malnourished(20) does not eliminate the risk of more than minimal harm to other residents. The risk stems from Petitioner's incorrect interpretation of low albumin levels. Not all of Petitioner's residents with low albumin levels can be expected to have RESIDENT 4's concerns for maintaining her weight at the same level. Nor will all other residents with low albumin levels benefit from being maintained on their existing diet. Those other residents could suffer serious health consequences from Petitioner's incorrect assessment that a diet which has resulted in low albumin level readings was providing those residents with 100 percent of their protein needs.
Accordingly, I conclude that Petitioner's evidence concerning its assessment of RESIDENT 4 has not rebutted HCFA's prima facie case of Petitioner's noncompliance with 42 C.F.R. § 483.20(b).
C. RESIDENT 5 of First Survey
For RESIDENT 5, HCFA notes that the MDS form was not completed correctly by Petitioner. The section titled "Edema" was left blank when Petitioner should have filled in the section based on information in its nursing report. HCFA Br., 12, 79; P. Ex. 45 at 3. Additionally, even though Petitioner's registered dietician was aware of this resident's fluid retention problem (e.g., Tr. 1250), Petitioner's RAP sheet for September 1995 contains no mention of this problem. HCFA Br., 79; P. Ex. 45 at 7 - 8. The dietician's nutritional assessment, which allegedly addressed this resident's fluid retention problem, was not referenced by Petitioner's RAP assessment sheet. Id. HCFA contends, inter alia, that the above failings by Petitioner posed a risk for more than minimum harm to this resident because she has a history of congestive heart failures and her treating doctor's testimony indicated that excess hydration could cause her heart to fail again. Id. (citing Tr. 1308, 1311).
In attempting to rebut HCFA's prima facie showing of noncompliance for RESIDENT 5, Petitioner contends that no edema was noted on the MDS form because this form was completed on September 19, 1995 and its instructions asked for identification of only those problems present during the previous seven days. According to Petitioner, there is "absolutely no indication from the documentation submitted that seven days prior to 9/19/95, this resident had edema." P. Reply, 8. However, as correctly pointed out by HCFA, nursing note entries dated September 15 and 16, 1995 refer to this resident's "non-pitting" edema and to her continuing to experience slight edema in both her ankles. HCFA Br., 12 (citing P. Ex. 47 at 1, 2). Therefore, even on the basis of the foregoing facts alone, I agree with HCFA that Petitioner had failed to assess this resident accurately or comprehensively in accordance with the requirements of 42 C.F.R. § 483.20(b).
In its defense, Petitioner attempts to show also that the fluid retention or edema problem was in fact noted and evaluated by its registered dietician on the nutritional assessment form she completed. See Tr. 1250. (Petitioner is relying on the fact that a facility is not required to use any specific forms when conducting the RAPs assessments.) However, the material question here is not whether an assessment was in fact done for the problem, but whether the assessment was done as part of the comprehensive assessment process mandated by 42 C.F.R. § 483.20(b).
Petitioner has introduced its own form which is titled "RAP Summary Sheet." P. Ex. 45 at 7 - 8. Yet, when Petitioner's staff completed the "RAP Summary Sheet" for RESIDENT 5, they did not place into that document any reference to the resident's edema problem contained in the dietary assessment. Thus, there is no objective support for the proposition that the dietician assessed the edema problem for the RAPs process in order to complete a comprehensive assessment of this resident.
Additionally, the state of Petitioner's records concerning RESIDENT 5 undercuts its allegations of compliance with 42 C.F.R. § 483.20(b). Even though both parties have focused on this 81-year-old resident's medical history, condition, and ailments in order to argue what should have been assessed, they do so with use of Petitioner's records. Those records contain material conflicts and call into question the accuracy of Petitioner's assessments, as well as why Petitioner used the process it did for these residents. Even though not all of these conflicts were identified by HCFA, I discuss them below because Petitioner, having introduced those documents as its own exhibits, can be imputed with knowledge of their contents.
According to Petitioner's exhibits, Petitioner had admitted this resident, a Medicare beneficiary, into its skilled nursing facility on September 5, 1995 when she may not have been in need of a skilled nursing level of care. Petitioner acknowledges that RESIDENT 5 was admitted on September 5, 1995 (P. Br., 11) "for the express purpose of obtaining extended care following her hospitalization to return home" (P. Br., 12). What this statement means is that she was admitted to the skilled nursing facility because her attending physician and her family members had discussed the matter and decided that no one was available at that time to care for her at home. P. Ex. 61.
Dr. Metwally, this resident's attending physician and an employee of the hospital which owns the skilled nursing facility (Tr. 1318 - 19), reported that she was admitted to Petitioner's "Skilled Nursing Facility for continued medical care until we arrange for home care for her in the near future." P. Ex. 61 at 1.(21) Prior to this September 5, 1995 admission, she had been hospitalized at Petitioner's facility for acute pulmonary edema and shortness of breath and then transferred to Petitioner's Rehabilitation Floor in order to build her strength and receive intensive rehabilitation therapy. Id. Dr. Metwally described the resident as having been "reluctant about being kept in the SNF Unit" to await arrangements for her care at home. Id. However, she conferred with her family members, and Dr. Metwally reported that "we decided to keep her and admit her in the SNF Unit for maintaining her medical treatment and her physical and nursing needs." Id.
On December 7, 1995, Dr. Metwally signed the "Admission History & Physical" form, which listed September 13, 1995 as the date this resident was discharged from Petitioner's skilled nursing unit. P. Ex. 61. The "Discharge Summary" signed by Dr. Metwally
on December 7, 1995 also listed the date of discharge as September 13, 1995. P. Ex. 60.(22) Three times in this "Discharge Summary," Dr. Metwally specifically stated that this resident was "discharged home." Id.
Given that Dr. Metwally was this resident's physician and signed the above-cited two documents several months after the discharge date that he had mentioned repeatedly, it does not appear likely that he was mistaken about the duration of her stay at Petitioner's long-term care facility. Moreover, Dr. Metwally's repeated reports of this resident's having left Petitioner's facility on September 13, 1995 for home care appears consistent with other records Petitioner has also placed into evidence. There is a written report that an individual employed by or affiliated with Petitioner made a "House Call" of 15 minutes on September 18, 1995. P. Ex. 52 at 1. The same individual again reported having made house calls ("H. Calls") to this resident on September 22 and 25, 1995. P. Ex. 58 at 2.
However, Petitioner contends that this resident had been at its long-term care facility for the 17 days preceding the September 21, 1995 survey. P. Br., 11 at n.6. According to the MDS form, this resident was assessed September 19, 1995. P. Ex. 45 at 1. The dates of entry on Petitioner's care plan for this resident extend from September 9, 1995 until September 19, 1995 (P. Ex. 46), even though the above-discussed records generated by Dr. Metwally and others for Petitioner indicate that this resident had been discharged from the skilled nursing facility as of September 13, 1995.
Other records maintained by Petitioner conflict also with the apparent discharge of RESIDENT 5 on September 13, 1995 under Dr. Metwally's order. In Petitioner's document called "Skilled Nursing Facility Discharge Plan," for example, the word "none" is entered in response to the question concerning the anticipated discharge date. However, this discharge plan was signed by one of Petitioner's employees on September 18, 1995 (P. Ex. 51), the same day that another staff member was reporting her "House Call" to this resident on another of Petitioner's forms (P. Ex. 52 at 1).
Petitioner's assessment records for RESIDENT 5 indicate a chronology that is only slightly less questionable. Even though the MDS form for this resident was not completed until September 19, 1995 (P. Ex. 45 at 1), Petitioner prepared its care plan for this resident between September 6 and 19, 1995 (P. Ex. 46)(23) and Petitioner performed the RAPs for this resident from September 11 until September 19, 1995 (P. Ex. 45 at 7 - 10).(24) The dates on these documents do not lead to the conclusion that information entered on the MDS form was used to trigger the RAPs assessments or that the information entered on the MDS and RAPs assessments were then used to formulate this resident's plan of care.
For the foregoing reasons, I conclude that Petitioner has not rebutted HCFA's prima facie showing of noncompliance.
D. RESIDENT 9 of First Survey
Even though HCFA has summarized various criticisms made by the surveyors in their observations of the physical restraint devices used on RESIDENT 9 (HCFA Br., 12 - 13, 80), the problems which relate to Tag F-272 stem from Petitioner's failure to assess whether and how the use of those physical restraints may have been affecting this resident's urinary and bowel incontinence. The assessment documents before me show, for example, that Petitioner had completed an initial assessment on October 31, 1994 which showed its awareness that this resident was using a vest restraint and that she was incontinent as well. P. Ex. 94 - 96. However, there was no evaluation by Petitioner on whether or to what extent the use of this physical restraint device might have been contributing to this resident's apparent inability to use the toilet on her own when necessary. P. Ex. 95 at 5 - 6.
Petitioner's failure to assess this potential relationship acquired practical significance for RESIDENT 9 under the circumstances observed by the surveyor. Petitioner admitted that this resident was sitting in a geri-chair with a vest restraint on throughout the survey of September 1995. P. Reply, 9. It acknowledged also that one purpose served by the geri-chair was to "slow him down." P. Reply, 9 - 10.(25) Notwithstanding the surveyor's testimony that she observed no one taking this resident to the toilet, Petitioner did not respond that toileting was in fact done on a regular schedule for this resident. P. Br., 15. Petitioner criticized only the length and distance of the surveyor's observation. Id. Accordingly, these facts of record raised the important issue of whether this resident had a bowel and bladder incontinence level of "3" ("Frequently Incontinent") as rated by Petitioner on the MDS form because he wore a vest restraint, sat in a geri-chair, and was unable to use the toilet on his own. See P. Ex. 94 at 2.
HCFA contended that Petitioner's evaluation of this resident's incontinency should have included consideration of the effects of the physical restraint devices in use and whether lesser restrictive measures would have sufficed while alleviating the incontinency problems. HCFA Br., 79 - 80. Petitioner's argument is that, since it had already indicated on its RAPS sheet its conclusion that this resident's potential for becoming continent was "nonexistent," "[t]hus, the issue of the use of the restraint as it relates to incontinence is a red herring." P. Br., 15. However, the regulations do not require a full assessment for only those residents who will become continent or regain their prior functions. Instead, Petitioner was required to conduct a comprehensive, accurate, standardized, and reproducible assessment of each resident's functional capacity and needs so that its results may be used to develop, review, and revise the resident's comprehensive plan of care, which must include "the services that are to be furnished to attain or maintain the resident's highest practicable physical, mental, and psychosocial well-being . . . ." 42 C.F.R. §§ 483.20(b)(6), 483.20(d)(1)(i).
As measured against the regulatory requirements, Petitioner's failure to assess the relationship between the use of physical restraint devices and an incontinence rating of "3" ("Frequently Incontinent") for RESIDENT 9 had an impact upon his ability to attain and maintain his highest practical level of physical well-being despite his inability to ever become continent. Additionally, the surveyor testifying for HCFA established that incontinence can increase the risk of "skin integrity problems." Tr. 314. From this evidence it is reasonable to conclude that a correlation exists between the degree of incontinence and the degree of risk for "skin integrity problems." Thus, the omissions in Petitioner's assessment of this resident had the potential for causing more than minimal harm to the state of his health being elevated to and maintained at the highest practical level possible.
For the foregoing reasons, I conclude that Petitioner was out of compliance with the requirements of 42 C.F.R. § 483.20(b), as evidenced by its assessment of RESIDENT 9 during the survey of September 1995.
FFCL 5: As shown by the evidence concerning RESIDENTS 1, 4, 5, and 10 of Survey 1, Petitioner was not in substantial compliance with the care plan requirements of 42 C.F.R. § 483.20(d) during the first survey.
During the initial survey, the surveyors found that Petitioner's noncompliance with the requirements of 42 C.F.R. § 483.20(d)(also denoted as Tag F-279) appeared in the records of 10 out of the 11 residents they sampled. HCFA Ex. 3 at 26. In the proceedings before me, HCFA relies on the examples of RESIDENTS 1, 4, 5, and 10 to illustrate Petitioner's noncompliance with the care plan.
A. RESIDENT 1 of First Survey
RESIDENT 1 is the individual discussed above, for whom Petitioner had failed to make a comprehensive and accurate written assessment of her severe and rapid weight loss problem on the basis of, inter alia, its specious defense concerning the existence of an "advance directive." The surveyors had cited Petitioner's assertion of such a defense in concluding:
RESIDENT 1 lacked a complete and comprehensive care plan addressing the treatment and services being withheld based on the power of attorney exercising his/her rights. The specific treatments being withheld were not identified in the care plan. Alternative interventions were not developed that could possibly be beneficial to the resident in light of weight loss and abnormal laboratory findings.
HCFA Ex. 3 at 26.
Given the reasons I have already set forth for rejecting Petitioner's alleged reliance upon an "advance directive," I do not need to explain also my reasons for accepting the above-quoted conclusions made by the surveyors concerning the inadequacies in the resulting care plan for this resident. Instead, I will focus on the additional body of evidence relied upon by HCFA to show that the care plan prepared for this resident was out of compliance with 42 C.F.R. § 483.20(d) for other reasons as well.
HCFA noted that a surveyor assigned to the September 1995 survey had observed RESIDENT 1 sitting outside her room in a geri-chair with a tray table in place. HCFA Br., 14. Petitioner's Assessment Coordinator conceded that this resident did sit outside her room with the tray table in place. Tr. 890 - 91. She added that the resident was "status post hip fracture. And
. . . you don't want them to get up and walk, and do more injury to the hip." Tr. 891.
HCFA properly considered the geri-chair with tray table in place as physical restraints for this resident. Therefore, HCFA emphasized the absence of certain information from the care plan concerning the use of physical restraints for this resident. It notes that Petitioner's care plan sheets do not even list the use of physical restraints as a problem which needed to be planned for. HCFA Br., 14 (citing P. Ex. 3). According to HCFA, a comprehensive care plan for this resident should have included interventions for discontinuation of the physical restraints.
Petitioner responds that there is no appropriate nursing diagnosis listed as "restraint usage," and no magic words are necessary when discussing the issue of restraints. P. Reply, 10. It contends that "it did address the use of restraints when it had its care planning problem entitled 'Potential for Injury Related to History of Multiple Falls and Multiple Risk Factors.'" P. Reply, 10 (citing P. Ex. 3 at 1). Also according to Petitioner, "[t]he interventions for this problem refer to the use of a geri chair and side rails indicating that 'restraint' usage had been appropriate[ly] addressed." P. Reply, 10.
The care plan referenced by Petitioner does have the phrase quoted by it as a "problems/nursing diagnosis" for the resident. P. Ex. 3 at 1. Next to this phrase, Petitioner had also included sitting "in a geri-chair" as an approach or intervention for attaining the stated goal of "hav[ing] no falls or injuries" for this resident. Id. However, Petitioner misses the mark by relying on this information as its defense to HCFA's criticisms of the care plan done for RESIDENT 1.
The use of physical restraints such as a geri-chair with attached tray table(26) will prevent some falls. However, it does not follow from this fact that every resident at risk for falls should have a physical restraint device in place, or that the restraint device should be used indefinitely. While serving the function of preventing falls, the use of physical restraints can also limit an individual's physical mobility. The foregoing fact is especially significant for RESIDENT 1, because Petitioner had especially stated that it "does not dispute the fact that she had the potential to increase her physical mobility." P. Reply, 11.
Petitioner had an obligation to plan for this resident to attain her highest practical level of well-being. The regulation itself specifies the inclusion of "measurable objectives and timetables" in each care plan. 42 C.F.R. § 483.20(d)(1). Therefore, as urged by HCFA, it is appropriate to give significance to the fact that the care plan for this resident does not indicate that less restrictive alternatives to the physical restraints had been considered to prevent this resident from falling. It is also appropriate to give weight to the fact that the care plan prepared by Petitioner does not indicate whether, when, or in what manner this resident should be eased from the use of the physical restraints.
For these reasons, I agree with HCFA that the care plan done for this resident concerning the use of physical restraints was deficient. Additionally, I find also that the omissions in the care plan placed this resident at risk for not attaining her highest level of physical functioning. Such a risk is more than minimal. Therefore, Petitioner was out of compliance with 42 C.F.R. § 483.20(d) for RESIDENT 1.
B. RESIDENT 4 of First Survey
Using RESIDENT 4, HCFA seeks to show how Petitioner was providing services which were not specified in the care plan Petitioner had prepared.
HCFA notes that, at the time of the September 1995 survey, Petitioner's care plan did not provide for this resident to be administered the medication Propolis or for having her mouth suctioned. HCFA Br., 14 (citing HCFA Ex. 3 at 28). HCFA relies also on the testimony of Petitioner's witnesses, who conceded that the resident's family was providing the Propolis medication and the suctioning service even though this resident's care plan did not so provide. HCFA Br., 14. HCFA's theory appears to be that, in light of these additional treatments provided by her family, the care plan prepared by Petitioner was either deficient or should have been revised pursuant to reassessments.
HCFA contends that this resident would be placed at risk for more than minimal harm due to the deficiencies in her care plan. In support of the harm contention, HCFA notes that the possible adverse interaction of Propolis and those drugs listed on her care plan have never been evaluated. HCFA Br., 91. Additionally, some staff members and other medical providers may not know that the family members are administering Propolis to the resident. Id.
Petitioner admits that this resident's care plan was not revised to address the administration of Propolis until after the surveyors found the facility out of compliance with the care plan requirements. P. Reply, 12. Petitioner alleges, however, that Propolis was used to treat this resident's "spiritual needs," and, therefore, "[t]he resident's right to exercise her religious use of Propolis far outweighs any alleged harmful interaction that may occur." Id.(27)
I do not find Petitioner's arguments persuasive.
First of all, Petitioner has not shown that the care plan in effect for this resident during the September 1995 survey addressed the use of Propolis. Nor has Petitioner shown that, in forming the care plan for this resident, it had evaluated the potential for adverse effects from Propolis and her other medications. If the formulation of a care plan for this resident had entitled Petitioner to weigh the benefit of Propolis to her spiritual well-being against the potential harm of its interaction with other drugs she was also administered, this weighing process should have been indicated in the care plan in effect during September 1995 instead of inserted in a brief prepared for Petitioner years later.
More significantly, appropriate care planning for potential drug interactions should have been done by Petitioner without regard for whether this resident was taking medicine for religious and spiritual reasons. A potential for drug interaction is not eliminated by the fact that someone has certain religious beliefs. A facility may allow a resident to take certain medications for religious reasons and make provisions in that resident's care plan for appropriate intervention should adverse drug interactions occur.
The fact that Petitioner had once written that RESIDENT 4 was "very spiritual," had "strong religious faith," and "believe[s] that propolis will help prevent rapid deterioration of her M.S. [multiple sclerosis]" (P. Ex. 36 at 1) is not sufficient for establishing that the facility was in compliance with the care plan requirements for this resident. These remarks appear in the "Problems/Nursing Diagnoses" section of a Care Plan dated June 1994. Id. However, the relevant approach and intervention noted in the 1994 care plan was only that the family would supply the Propolis for Petitioner to administer. Id. Having the resident's family provide the Propolis clearly does not suffice as adequate or appropriate care planning, since the resident would be ingesting Propolis in any event and be placed at risk for the consequences of drug interactions.
For these reasons, I conclude that HCFA has proven Petitioner's failure to comply substantially with the requirements of 42 C.F.R. § 483.20(d) for RESIDENT 4.
C. RESIDENT 5 of First Survey
As I had discussed in the previous "assessment" section of this decision, RESIDENT 5 is the individual who was admitted from Petitioner's hospital side into its skilled nursing unit as an accommodation to her family, to await arrangement for someone to live with and care for her at home.
In using the records of RESIDENT 5 to prove Petitioner's noncompliance with the care plan requirements, HCFA focuses on the requirement for specifying timetables and measurable objectives. 42 C.F.R. § 483.20(d)(1). HCFA cites various deficiencies under this requirement, including Petitioner's alleged failure to address certain problems indicated by this resident's abnormal laboratory test results. These abnormal laboratory test results were obtained while this resident was a patient in Petitioner's hospital, shortly before she was transferred to Petitioner's skilled nursing unit.
HCFA notes also that the laboratory tests done of this resident while hospitalized showed abnormal potassium level readings. Therefore, upon her admission to Petitioner's long-term care unit a few days before the September survey, Petitioner should have created a care plan which included monitoring for her potassium levels and the interventions for this problem. However, the care plan and nutritional assessment prepared by Petitioner for this resident did not address her abnormal potassium level readings. HCFA Br., 15 (citing Tr. 1249; P. Ex. 46; P. Ex. 56).
HCFA contends also that the care plan for this resident was significantly flawed for its failure to address a potentially painful and movement-limiting problem indicated by the high uric acid level readings usually associated with gout. HCFA Br., 15 (citing Tr. 150 - 51; P. Ex. 46; P. Ex. 48 at 1).
HCFA criticizes the care plan for this resident also because it does not provide for monitoring of the Coumadin levels in her blood, or for checking on bleeding. HCFA contends that monitoring and special care should have been planned by
Petitioner because this resident's attending physician had reported the following information prior to admitting her to Petitioner's skilled nursing unit:
[o]n Coumadin 1 mg 1 pm . . . Anti-coagulation is provided for this purpose [congestive heart failure] because of the low ejection fraction, however, because of the Prelosic drug interaction predisposes her to Coumadin toxicity. Although her Coumadin dosage is only 1 mg q d; her INR tends to be 2 or more.
HCFA Br., 15 (quoting P. Ex. 46, emphasis added). Even though Petitioner claimed that its nurses did not need specific information in a care plan to be concerned about the risks created by Coumadin, HCFA points out that nothing indicated the staff's awareness of the physician's special concerns for this resident predisposition for Coumadin toxicity due to the interaction between Coumadin and Prelosic. HCFA Br., 15.
In defense of these deficiencies in its care plan for RESIDENT 5, Petitioner suggests that HCFA had disregarded the fact that the primary reason for this resident's admission to the skilled nursing unit was for acute rehabilitation of her compromised condition caused by congestive heart failure. P. Br., 21 - 23. Petitioner argued also that the resident's attending physician, Dr. Metwally, was actively involved in her care while she was in Petitioner's skilled nursing unit, and Dr. Metwally had not criticized the care she received. P. Reply, 12 - 14. Therefore, Petitioner suggests that HCFA had attributed undue and inappropriate significance to Petitioner's failure to address in the care plan her other medical problems such as gout and abnormal potassium levels. P. Br., 21 - 23.
As for the failure of the care plan to address this resident's predisposition for Coumadin toxicity due to its interaction with another drug she was also taking, Petitioner relies on the fact that Dr. Metwally had an office close by and routinely received phone calls from Petitioner's staff. P. Br., 23. Moreover, Dr. Metwally was of the opinion that the nursing staff of most facilities are familiar with the signs and symptoms of toxicity. Id.
I do not find Petitioner's defenses valid or in accord with the facts of record.
As I had found in discussing the documents relevant to Petitioner's assessments of RESIDENT 5, this resident was admitted to Petitioner's skilled nursing unit from Petitioner's hospital primarily as an accommodation to her family, because no one was available to live with and supervise her at home. No doubt, these primarily non-medical reasons for her stay at Petitioner's skilled nursing unit bear on why Petitioner's staff had generated the defective and insufficient assessment records and care plan under review. As previously noted, Petitioner had begun a care plan for this resident on September 6, 1995 but the MDS form for her was not completed until September 19, 1995. P. Ex. 45; P. Ex. 46. Moreover, four days before the MDS form was completed, Petitioner began planning for this resident's discharge. P. Ex. 45; P. Ex. 46 at 3.
Nevertheless, Petitioner has chosen to maintain that this resident was admitted in early September 1995 for the receipt of medically reasonable and necessary services from its skilled nursing unit,(28) that its staff was aware of the medical problems cited by HCFA, and that there was no need to make provisions for them on the care plan. P. Br., 21 - 22; P. Reply, 12 - 14. Therefore, HCFA and the surveyors were entitled to scrutinize the care plan for the completeness mandated by 42 C.F.R. § 483.20(d). The results of such scrutiny by the surveyors and HCFA show that Petitioner was disregarding the need to prepare a care plan for the delivery of services which would enable the resident to attain her highest level of practical well-being.
Nothing in the care plan regulation entitled Petitioner to limit its efforts to the most significant manifestations of a resident's multiple problems. Petitioner's evidence shows only that this resident was not in imminent danger of death due to gout and her abnormal potassium levels during September 1995. Petitioner has not made any credible showing that the state of her general health would not have deteriorated further were these problems to continue. Nor has Petitioner made a credible showing that care planning, and providing services thereunder, for those non-life threatening conditions, would not have helped the resident to attain or maintain her highest practicable level of well-being.
As a matter of law, Dr. Metwally's proximity and involvement in the resident's care are not legal substitutes for what should have been included in a written and complete care plan prepared by Petitioner. Additionally, I find inadequate factual support for Petitioner's contention concerning the extent of Dr. Metwally's involvement or knowledge of this resident's needs after she was admitted to Petitioner's skilled nursing unit. I note, for example, that he wrote two reports in December 1995, stating that this resident had been discharged from Petitioner's skilled nursing unit on September 13, 1995. P. Ex. 60; P. Ex. 61. Yet, Petitioner's other records show a much longer stay, until October 9, 1995, in the skilled nursing unit. P. Ex. 55.
Dr. Metwally's specific written remark concerning this resident's predisposition for Coumadin toxicity due to its interaction with the other medication makes irrelevant his and others' testimony concerning the ability of most nursing staff members to recognize Coumadin toxicity when they see it. It is not reasonable to interpret the physician's notation as an extraneous comment summarizing the knowledge allged to be commonly known to nursing staffs concerning the signs and symptoms of Coumadin toxicity. The notation establishes that this resident was not a person of ordinary susceptibility to Coumadin toxicity and that she should not be monitored as such. The notation was clearly advising of the likelihood of Coumadin toxicity in RESIDENT 5 due to the use of another medication, which made it appropriate for Petitioner to plan for greater than usual vigilance and more prompt action in meeting those needs which were likely to result. Therefore, I conclude that Petitioner's failure to address this resident's predisposition for Coumadin toxicity in the care plan was material and had also placed her at risk for more than minimum harm.
D. RESIDENT 10 of First Survey
For RESIDENT 10, HCFA's noncompliance determination is based on the fact that Petitioner had set no goal for the low oral intake problem noted in this resident's care plan. HCFA Br., 16 (citing HCFA Ex. 3 at 29). HCFA pointed out that Petitioner's staff members gave testimony indicating that no goal had been specified on the care plan for the oral intake problem because they had "forgotten" to do so or made a "documentation error." Id. (citing Tr. 1262; Supp. Tr. 514). As with RESIDENT 5, above, HCFA focuses on the requirement for all comprehensive care plans to specify timetables and measurable objectives for meeting those needs identified in the comprehensive assessment. 42 C.F.R. § 483.20(d)(1).
Petitioner does not deny that this resident needed an increase in oral intake or that such a goal should have been set out in the resident's care plan. Petitioner confirms that it is claiming "documentation error" to explain its omission. P. Reply, 14. It argues, moreover, that this resident was not at risk for more than minimum harm since an otherwise comprehensive care plan had been developed containing other measurable objectives. Id. Petitioner asserts also that finger foods and snacks were in fact provided, and, therefore, the lack of a goal in the care plan was of no consequence to the care he received. Id.
I especially reemphasize here my earlier observation that the problems in Petitioner's assessment records and care plans are too numerous and too similar for each problem to be perceived as mere oversight. Petitioner's arguments have consistently sought to minimize the regulatory requirement for completeness in the care plans it creates. For RESIDENT 10 as for other residents, Petitioner continues to disregard the fact that harm to residents is not determined simply in terms of whether the services provided to them will cause them to die, as indicated by the following argument by Petitioner:
[i]n fact, there was no potential for more than minimal harm for this resident and, certainly, not a potential related to a failure to provide nutrition to this resident because "nutrition is vital to a person's health."
P. Reply, 14 (quoting from P. Br., 93).
Compliance with the regulation is not simply a matter of entering the words "needs to increase dietary intake" under a section of the care plan titled "goals." Rather, a facility must set forth on the care plan the "measurable objectives and timetables," as well as "the services that are to be furnished" for meeting the resident's need in order for him to attain or maintain his highest practicable level of functioning or well-being. 42 C.F.R. § 483.20(d)(1). The regulatory requirements for these types of information, coupled with a facility's obligation to provide services in accordance with the plan of care (42 C.F.R. § 483.25), would ensure against the arbitrary, inconsistent, or erratic dispensing and withholding of care in accordance with the judgment of individual staff members. The information would also enable an objective evaluation of whether the resident's need is being met as anticipated and whether adjustments in intervention methods should be made. Therefore, even if members of Petitioner's staff had given RESIDENT 10 finger food and snacks, I would still find that a potential for more than minimal harm to this resident had been created by Petitioner's failure to specify measurable objectives and timetables for the services to be furnished to this resident for increasing his dietary intake.
During December 1995, the surveyors revisited Petitioner's skilled nursing facility in order to verify Petitioner's allegation that it had undertaken corrective actions and attained substantial compliance with all program requirements. HCFA Ex. 1, 2, 6. However, the surveyors found, once again, various areas of alleged noncompliance. Included were Petitioner's continued noncompliance with 42 C.F.R. §§ 483.20(b), 483.20(d) (Tags F-272 and 279, respectively). HCFA Ex. 6 at 4 - 9.
FFCL 6: As shown by the evidence concerning RESIDENT 2 of Survey 2, Petitioner continued to be out of substantial compliance with the requirements of 42 C.F.R. § 483.20(b) during the second survey.
In determining that Petitioner had remained out of compliance with 42 C.F.R. § 483.20(b), HCFA relied on Petitioner's failure to assess for seizures or seizure-like activities in an individual designated as RESIDENT 2 for the December 1995 resurvey. HCFA contends that the annual assessment of this resident done by Petitioner on December 4, 1995 contains material omissions relating to the history of a seizure disorder and the discontinuation of anticonvulsive medications. HCFA contends also that Petitioner had failed in its duty to reassess "[p]romptly after a significant change in the resident's physical or mental condition. . . ." 42 C.F.R. § 483.20(b)(4)(iv). According to HCFA and its witness, there were seizures or seizure-like activities experienced by this resident between the initial survey of September and the resurvey of December which should have been considered a significant change under the regulation.
For the reasons which follow, I find that HCFA has established Petitioner's noncompliance with 42 C.F.R. § 483.20(b) through the use of RESIDENT 2 as an example. Petitioner's omissions at the time of the resurvey and its explanations show that it remained unable to comply substantially with the regulatory requirements.
A. Analysis of HCFA's evidence and arguments for RESIDENT 2 of Survey 2
The surveyor determined on the basis of the nursing notes for October 17 and December 15, 1995 that RESIDENT 2 had experienced seizures or seizure-like symptoms on those days.(29) HCFA Ex. 6 at 6. The surveyor noted also from her review of Petitioner's records that the resident had a history of seizure and anticonvulsive medications had been discontinued in December 1994. Id. Therefore, when this resident was at Petitioner's
facility for the resurvey on December 20, 1995, the surveyor expected to see that relevant and timely assessments had been done.
The surveyor found that no MDS form or RAPs has been generated shortly after the resident's October 17 episode. Petitioner's nursing notes, as interpreted by HCFA and the surveyor, indicated that the seizure-like episode of October 17 had lasted 5 seconds, wherein the resident took a deep breath, appeared to relax and then bit her tongue. HCFA Br., 25 (citing Tr. 534).(30) HCFA pointed out also that, according to the testimony of Petitioner's R.N. Assessment Coordinator, she was a witness to the October 17 episode; she had seen this resident's face turn red, and that the resident had "blowing respiration," and had a tense upper body for about 5 to 15 seconds. HCFA Br., 25 (citing Tr. 881). After witnessing the October 17 episode, Petitioner's RN Assessment Coordinator did not do a revised or updated MDS form because she did not believe such a procedure was indicated by the MDS Manual, and she did not think the seizure-like activities had arisen to the level of a significant change in the resident's condition. HCFA Br., 25 (citing Tr. 882).
Petitioner waited until the beginning of December 1995 to conduct a routine, annual assessment of this resident.
During the December resurvey, when the surveyor reviewed the MDS form and RAPs done by Petitioner during early December 1995 for this resident, the surveyors found no assessment for the seizure-like symptoms of October 17, 1995. Id.; HCFA Br. 24 (citing surveyor's testimony at Tr. 514 - 15).(31) However, during the hearing, Petitioner attempted to demonstrate that the surveyor had misread relevant information. Petitioner introduced into evidence a copy of a MDS form dated December 4, 1995, on which there was a check mark placed next to the box for "seizure disorder." HCFA Br., 25 (citing P. Ex. 29 at 5). The surveyor then testified that there was no such check mark on the MDS sheet she reviewed on-site during the December 1995 survey. HCFA Br., 25 (citing Tr. 518). In an apparent effort to show that Petitioner's staff had added the check mark for "seizure disorder" to a December 4, 1995 MDS form after the resurvey was completed, HCFA pointed out also that nothing in the RAPs sheets submitted by Petitioner (dated December 5 and 7, 1995) mentioned this resident's seizure-like episode of October 17 or the history of a seizure disorder. HCFA Br., 24 (citing P. Ex. 30).(32) Petitioner does not allege that RAPs were done for these seizure-like symptoms.
In further support of its noncompliance determination, HCFA notes that when the resident's physician was contacted by Petitioner's staff concerning the occurrence of the October 17 episode, the physician told Petitioner's staff to watch this resident and to advise him if anything else should happen. HCFA Br., 24 (citing testimony concerning nursing notes).
Petitioner's staff witnessed another of RESIDENT 2's seizure or seizure-like episodes on December 15, 1995, a few days before the resurvey was conducted. As pointed out by HCFA, Petitioner's nursing notes stated:
12/5/95 - 3:30: - CNA [Certified Nursing Assistant] stated patient looked like she was having a convulsion, her tongue was protruding and tongue looked bluish.
HCFA Br., 26 (citing P. Ex. 31, at 2). Yet, Petitioner's documents did not indicate that the physician had been contacted per his instruction until December 20, 1995, the day the resurvey was completed. HCFA Br., 24, 26 (citing P. Ex. 31, at 3). Nor did Petitioner complete another MDS form or related RAPs sheets in order to reassess this resident for possible recurrence of seizures and their potential impact on her daily living activities. See HCFA Br., 24 (citing surveyor testimony).
HCFA notes the surveyor's testimony that, when she raised these omissions during the resurvey on December 20, 1995, Petitioner's Director of Nursing responded that there had been no reason to contact the physician and that this resident would not be placed on Dilantin, an anticonvulsive medication. HCFA Br., 24.
It was not until sometime after the resurvey that Petitioner informed this surveyor that the resident had experienced another episode of seizure or seizure-like activities on December 29, 1995 for approximately one minute. HCFA Br., 24, 26. For that post-resurvey episode, Petitioner did contact the physician on the same day, and the resident was placed on Dilantin immediately for routine administration thereafter. Id. For the December 29, 1995 episode, the symptoms also included protrusion of the tongue and "blowing respirations," as well as shaking arms and staring eyes. HCFA Br., 26 (citing P. Ex. 31 at 3 - 4). Petitioner then completed a RAP sheet "addendum" for RESIDENT 2 on January 4, 1995, in which its R.N. Assessment Coordinator noted a prior history of seizure disorder and the "occurrence of seizure on 10-17-95 and again on 12/15/95." HCFA Br., 25 (quoting P. Ex. 33 at 1).
B. Analysis of Petitioner's evidence and arguments for the seizure-like symptoms experienced on October 17, 1995 by RESIDENT 2 of Survey 2
Petitioner acknowledges that this resident was observed by its staff to have experienced seizure-like activities on October 17, 1995. Petitioner argues, however, that the symptoms were isolated, not indicative of a "grand mal seizure," and the episodes had been of short duration after the resident had been seizure-free for nearly 10 months. P. Br., 48. Petitioner contends that the episode did not amount to a significant change in the resident's condition. Id. at 48 - 49. According to Petitioner, HCFA has given undue emphasis to the October 17 seizure-like episode because HCFA failed to understand that the purpose of the MDS is to assess only "current problems associated with the care and treatment of a resident in a manner to be able to effectively and efficiently provide quality of care" and that a "current problem is a problem which needs to be addressed immediately." P. Reply, 29 (emphasis in original).
According to Petitioner, this resident's October 17 episode was a noncurrent problem which was inappropriate for reference in the MDS or the RAPs completed during early December 1995. P. Reply, 29. Its reasoning is that only 18 RAPs may be triggered through the assessment process and "[s]eizure or seizure disorder or seizure-like behavior is not a triggered RAP." Id. To support its conclusion that the October 17 episode was a "noncurrent" problem for purposes of the December 1995 assessment, Petitioner relies also on the resident's seizure-free condition for more than 10 months and its belief that her physician "was certainly not going to treat based on one isolated incident." Id.
I reject Petitioner's contentions and conclusions. Petitioner's defenses of its omissions for the October 17, 1995 episode are at variance with the legal requirement that a comprehensive assessment be completed so that it may be used to develop a care plan which would describe the services that are to be furnished to "attain or maintain the resident's highest practicable physical, mental, and psychosocial well-being. . . ." 42 C.F.R. § 483.20(b)(6) (as it incorporates 42 C.F.R. § 483.20(d)(1)(i)).
The seizure-like activities experienced on October 17, 1995 by RESIDENT 2 (who had a history of seizure disorder and experienced the episode in the presence of Petitioner's staff) should have been considered a "current" problem to be assessed on or shortly after October 17--but most certainly by the time Petitioner generated the annual assessment documents during early December 1995. Even though this resident had been off of Dilantin and seizure-free for nearly 10 months, there is no evidence establishing that her previous use of the anticonvulsive medication had either eradicated the root cause of her seizure disorder or suppressed forever the recurrence of seizures or seizure-like symptoms. Nor does the evidence establish that Petitioner may reasonably rule out the occurrence of more serious or lengthier episodes of seizure-like symptoms after October 17, 1995, when its staff reported observing this resident biting her tongue, being red in the face, having "blowing respiration," and being tense in her upper body for 5 to 15 seconds.
Significantly, Petitioner assessed this resident as having severe Alzheimer dementia and being unable to communicate by any method. P. Ex. 29 at 3. Petitioner also knew that this resident was rarely or never able to make herself understood; similarly, she was rarely or never able to understand others. Id. Petitioner, as a skilled nursing facility, does not allege to have kept this resident under the observation of a staff member around the clock since her Dilantin use was discontinued during December 1994. Therefore, Petitioner lacks adequate factual foundation for its contention that the episode of October 17 was isolated in nature or that it was the first of such episodes experienced by the resident in 10 months.
Even though Petitioner noted the physician's testimony concerning the absence of seizure for nearly a year (P. Br., 48), the physician's conclusion suffers from the same defects as Petitioner's arguments. All that can be said for the episode of October 17 is that it was the first time this resident had exhibited symptoms in the presence of Petitioner's staff. If this resident had experienced seizures or seizure-like symptoms between December 1994 and October 17, 1995, she was not able to communicate them to Petitioner. Therefore, Petitioner knew or should have known that its failure to assess promptly for the October 17 episode of seizure-like symptoms had the potential for causing more than minimal harm to this resident who was unable to articulate her sensations or make known her need for help to anyone due to severe Alzheimer dementia.
Contrary to what Petitioner is suggesting, Petitioner is not relieved from its obligation to properly and completely assess the likely causes of this resident's seizure-like activities of October 17 because no diagnosis for "grand mal seizure" or an ongoing seizure disorder could have been made at that time. The regulation states very clearly that the comprehensive assessment must include "[m]edically defined conditions and prior medical history. . . ." 42 C.F.R. § 483.20(b)(2)(i)(emphasis added). Here, I reemphasize my previous discussions concerning the facility's obligation to do more than merely catalogue diagnoses on various pieces of assessment documents. The surveyors' testimony on this issue is consistent with the requirements of 42 C.F.R. § 483.20(b) in establishing that the assessment documents need to show that the staff understood which were the significant facts for the resident and that the staff understood and analyzed those facts in terms of their potential causes, likely results, and feasible interventions, so that an appropriate plan of care may be established. See, e.g., Tr. 242, 684, 834 - 35.
Whether a physician might or might not prescribe treatment does not relieve Petitioner from conducting its assessment in accordance with its obligations.(33) Even if I were to assume that the resident's physician would not want to place her back on Dilantin until Petitioner's staff observed more seizure-like activities, Petitioner could have conducted appropriate written assessments to determine, for example, whether a closer than usual watch should be maintained of this resident given her inability to communicate; whether additional episodes were likely; and whether the resident was at risk for injuring herself during such episodes--especially if they were experienced out of the presence of staff members.
I reject also Petitioner's contention that seizures, seizure disorders, or seizure-like behavior could not have been assessed under the available RAPs protocol. Petitioner listed the 18 RAPs triggers which allegedly precluded such assessments and attributed them to 42 C.F.R. § 483.315(e), (f). P. Br., 99. However, the federal regulation cited by Petitioner does not exist. Moreover, whatever the sources for the 18 RAPs triggers listed by Petitioner, it has not shown that the seizure-like symptoms experienced by RESIDENT 2 should not and could not have been assessed under the triggers of "Delirium," "Cognitive loss," "Visual function," "Communication," or "Behavioral symptoms," for example. Id.
C. Analysis of Petitioner's evidence and arguments for the seizure-like symptoms experienced on December 15, 1995 by RESIDENT 2 of Survey 2
With respect to the seizure-like symptoms which were again observed by Petitioner's staff on December 15, Petitioner submits different lines of argument. It appears to recognize the seriousness of its continued failure to assess for two known seizure-like episodes that had been experienced within 60 days. Therefore, Petitioner states that the "true issue is the action the facility took with regard to the alleged seizure occurring during the month of December." P. Br., 49.
Petitioner does not dispute that the resident's physician had asked to be notified if, after the October 17 episode, more seizure-like symptoms should recur. Petitioner admits that it did not do so on its own. It was not until 90 minutes after the surveyor had interviewed Petitioner's Director of Nursing on December 20 that Petitioner's staff alerted the physician to the resident's December 15 episode. P. Reply, 29 at n.25. Petitioner admits that it had done so at the surveyor's request but suggests that there had been no real need to notify the physician. P. Reply, 29.
In defense of its position, Petitioner points out that, on December 15, the resident was seen to have warm and dry skin, essentially stable vital signs, and a pink and moist tongue even after having been observed in an apparent convulsion, with her tongue protruding and having a bluish color. P. Br., 49 (citing P. Ex. 31 at 2). However, these visual observations do not suffice as an adequate assessment within the meaning of 42 C.F.R. § 483.20(b), for the reasons previously explained. Moreover, the doctor's instructions did not indicate that he wished notification only if certain signs or symptoms persisted or appeared.
In yet another line of defense, Petitioner notes also that the surveyor testified to having been told by Petitioner's Director of Nursing that "the Hospice nurse" had been advised. P. Reply, 29 (citing Tr. 519). Petitioner contends that doing so was "the usual and customary procedure for the care and treatment of a Hospice resident." P. Reply, 29. Petitioner contends that its failure to do more for this resident after the December 15 episode was appropriate "particularly in light of the fact that the resident was on Hospice care." P. Br., 49 (emphasis added). Petitioner criticizes the surveyor's failure to provide "competent testimony" concerning the appropriate standard of care for "a Hospice resident. . . ." P. Br., 50.
I am unable to give any legal significance to Petitioner's defense concerning RESIDENT 2's status as a "Hospice resident" "on Hospice care," or the fact that "the Hospice nurse" had been told of the December 15, 1995 episode. Nor do I perceive sufficient evidence of record to establish that the notification Petitioner allegedly gave to a "Hospice nurse" constituted the "usual and customary procedure for the care and treatment of a Hospice resident."
By its own description, Petitioner owns the 42-bed skilled nursing facility subject to the Medicare participation requirements published at 42 C.F.R. Part 483. P. Br., 1. If it were to be considered a "hospice care" provider under the Medicare program, it must be primarily engaged in providing care to terminally ill individuals (section 1861(dd)(1) of the Social Security Act (Act); 42 C.F.R. § 418.3) and be certified by HCFA as such (42 C.F.R. Part 418, subpart C). To be considered a hospice patient under the program, individuals must be "terminally ill," i.e., have the legally required medical prognosis and certification establishing that his or her life expectancy is six months or less. Section 1861(dd)(1), (3)(A) of the Act; 42 C.F.R. § 418.200. Additionally, the services provided to such hospice patients must be reasonable or necessary to the palliation or management of the terminal illness, as is consistent with the plan of care developed by the hospice for the Medicare beneficiary. 42 C.F.R. § 418.200.
In this case, RESIDENT 2's records were surveyed for Petitioner's compliance with 42 C.F.R. § 483.20(b) because she lived in and was being provided care by Petitioner's skilled nursing facility. The documents introduced by Petitioner do not even explain why Petitioner was in need of visits by a "hospice nurse." On one occasion, for example, Petitioner's nursing staff reported that "Donna from Hospice called back and told me to apply vaseline to rash on face." P. Ex. 31 at 1. Nor does the evidence establish Petitioner's knowledge of what use, if any, the hospice nurse would likely make of the information that the resident was seen to have undergone a seizure-like episode on December 15, 1995.
Even if this resident were in fact receiving hospice care under some other program or in accordance with other eligibility criteria not of record,(34) the evidence before me is insufficient for establishing the merits of Petitioner's reference to "the usual and customary procedure for the care and treatment of a Hospice resident." See P. Reply, 29. Whether or not this individual should be considered a "Hospice resident" for purposes of some other program, Petitioner is not relieved of its responsibilities under 42 C.F.R. § 483.20(b).
What the record shows is that this individual was an 84-year-old resident who was primarily suffering from severe Alzheimer dementia. According to Petitioner, there were advance directives regarding no resuscitation, as well as feeding restrictions. P. Ex. 29 at 1 - 2; P. Ex. 30 at 1. Nothing set forth by Petitioner on the MDS or RAPs forms indicates that this resident's life would end in the foreseeable future or that Petitioner was authorized to assess her with the expectation of an imminent death for her. P. Ex. 29; P. Ex. 30. While Petitioner's perception of RESIDENT 2's status as a "Hospice resident" on "Hospice care" might help explain Petitioner's pattern of omissions, I cannot accept Petitioner's recurring intimation that its gravely ill residents need not be assessed comprehensively for meeting those needs which would enable them to attain or maintain their highest practicable level of functioning while they remain alive in Petitioner's Medicare certified skilled nursing facility. See 42 C.F.R. § 483.20(b).
D. Analysis of Petitioner's remaining evidence and arguments concerning its omissions on the assessments completed during earlier December 1995 for RESIDENT 2 of Survey 2
As I noted above, Petitioner had waited until the beginning of December 1995 to conduct a routine, annual assessment of RESIDENT 2. I have found credible the surveyor's testimony that, contrary to what now appears in the MDS form of record (P. Ex. 29), the MDS form dated December 4, 1995 she had reviewed during the survey contained no check mark next to the box indicating "seizure disorder." I have found nothing in the RAPs sheets submitted by Petitioner (dated December 5 and 7, 1995) that mentioned this resident's seizure-like episode of October 17, 1995 or her history of a seizure disorder. See P. Ex. 30. Petitioner does not allege that RAPs were done for these seizure-like symptoms.
In its final line of defense, Petitioner contends that it had until December 29, 1995 (i.e., 14 days after RESIDENT 2's episode on December 15) within which "to complete an assessment of a significant chance [sic] prior to the completion of a new MDS." P. Br., 49. Petitioner points out that on the deadline date of December 29, 1995, the resident suffered another seizure-like episode. Therefore, at that point, her physician started her on Dilantin again to control those symptoms. Id.
From these arguments, I perceive Petitioner's final line of defense to be that HCFA's noncompliance conclusions were formed prematurely, as a matter of law, because its survey was completed on December 20, 1995--nine days before the assessment deadline noted by Petitioner. I reject these arguments. They are not supported by the law or the facts.
The regulation states specifically that assessments "must be conducted--. . . Promptly after a change in the resident's physical or mental condition. . . ." 42 C.F.R. § 483.20(b)(4)(iv) (emphasis added). The 14 days provided for assessing a newly admitted resident is not applicable to RESIDENT 2, who had undergone her "annual assessment" by Petitioner during early December 1995. See 42 C.F.R. § 483.20(b)(4)(i); P. Ex. 29 at 3 (Section A, 8). In completing its MDS form for this resident, Petitioner had designated its early December efforts to be "an annual assessment." P. Ex. 29 at 3 (Section A, 8).
The possibility that Petitioner might have thought that it had until December 29 to complete an assessment of the December 15 change in this resident's condition is belied by the fact that no such belief or intent had been conveyed to the surveyors during the December 20 resurvey. Petitioner does not allege that, during the interview with the surveyor on December 20, it had told the surveyor that the resident was currently being reassessed due to a change in her physical or mental condition. Additionally, the evidence before me simply does not support Petitioner's current intimation that, when the resident's symptoms recurred on December 15, 1995, it knew it needed to do a reassessment for this resident promptly.
Accordingly, for all of the foregoing reasons, I conclude that, with use of the assessments done by Petitioner for RESIDENT 2, HCFA has proven by a preponderance of the evidence that Petitioner continued to be out of substantial compliance with the requirements of 42 C.F.R. § 483.20(b).
FFCL 7: As established by the evidence concerning RESIDENT 1 of Survey 2, Petitioner continued to be out of substantial compliance with the requirements of 42 C.F.R. § 483.20(d) as of the second survey.
In the resurvey of December 1995, Petitioner was found out of compliance with the comprehensive care plan requirements of 42 C.F.R. § 483.20(d) (Tag F-279) on the basis of its records for five residents. HCFA relies on the example of RESIDENT 1 from this resurvey to establish the finding of continued noncompliance. HCFA Br., 26; HCFA Reply, 23.
RESIDENT 1 was readmitted to Petitioner's skilled nursing facility on December 6, 1995, after a stay in an acute care hospital. P. Ex. 123 at 2. When Petitioner was resurveyed on December 19 and 20, 1995, Petitioner had already generated various assessment documents for this resident. But Petitioner had not yet prepared a plan of care for her. HCFA Ex. 6 at 7.
One of the surveyors, a Registered Nurse, reported that Petitioner should have prepared a care plan for RESIDENT 1 to address a black eschar (lesion) on the heel of this resident's left foot. HCFA Ex. 6 at 7. The surveyor noticed this eschar while observing the decubitus ulcers (pressure sores) identified in the assessment documents Petitioner had prepared. HCFA Br. at 26 (citing HCFA Ex. 6 at 7; P. Ex. 123 at 6; P. Ex. 124 at 5). The surveyor reported also that the resident's feet were very dry and scaly and these problems were also not addressed in any care plan. HCFA Ex. 6 at 7.
According to the surveyor, this resident's care-giver stated during the survey that she was unaware of the left heel problem. HCFA Ex. 6 at 7. HCFA pointed out that Petitioner's R.N. Assessment Coordinator was also unaware of any black eschar on this resident, although she did concede the existence of a scab on the resident's left heel. HCFA Br., 26 (citing Tr. 871; Supp. Tr. 547).
The surveyor testified at the hearing that an eschar is more severe than a scab. Tr. 451. In his opinion, a care plan should have been prepared to quickly address the black eschar problem he observed because this resident had a history of amputation, diabetes mellitus, and peripheral vascular disease. HCFA Br., 26 (citing Tr. 494). The absence of planned treatment for the black eschar could result in lack of healing and eventual amputation of the foot. HCFA Reply, 23 (citing Tr. 442). To support the surveyor's opinion, HCFA noted that the RAPs sheet Petitioner completed on December 19, 1995 advised that this resident had pressure sores and was at risk for developing other pressure sores due to bowel incontinence and immobility. HCFA Br., 26 (citing P. Ex. 124 at 5).
I conclude that, even though the above-discussed evidence is not as strong as those facts which established Petitioner's noncompliance with 42 C.F.R. § 483.20(d) under the initial annual survey, HCFA has minimally met its burden of establishing a prima facie case of continued noncompliance. In reaching this conclusion, I have considered the fact that, by resurveying Petitioner during December 1995, the surveyors were giving Petitioner the opportunity to substantiate its allegation that it had remedied its prior noncompliance. Therefore, Petitioner had an obligation to demonstrate affirmatively that it had come into substantial compliance with the requirements of 42 C.F.R. § 483.20(d). Especially when considered in this context, Petitioner's reasons for having failed to prepare a care plan addressing the black eschar problem are not persuasive.
Petitioner raises as a defense its R.N. Assessment Coordinator's testimony that she was aware of only a small scab or crust no longer than the end of her finger. P. Br., 50 (citing Tr. 871). Petitioner suggests that said small scab or crust was really what the surveyor mistakenly overemphasized as a black eschar. Petitioner suggests also that it was not at fault for having failed to plan any care for the problem since such a scab or crust could have developed over the 24 hours immediately preceding the resurvey. P. Br., 51.
The problem with Petitioner's reliance on the R.N. Assessment Coordinator's testimony is that she never stated when she had observed the small scab or crust or on which foot she saw it on. Her lack of attention to details of the scab or crust is further shown by her unawareness of when it had cleared. Tr. 872. In contrast, the surveyor was very definite about the date of his observation and the location of the eschar. The testimony cited by HCFA indicates that the surveyor knew the difference between what should be called a scab as opposed to an eschar. Moreover, he even used the term "wound" in explaining his conclusions concerning the risks posed by the black eschar he found. Tr. 442.
Thus, Petitioner did not establish that the black eschar observed during the survey was really a small scab or crust. Nor did Petitioner refer to any testimony in support of its contention that a scab or crust of the size described by the R.N. Assessment Coordinator (even assuming that it was the black eschar identified by the surveyor) could have developed within 24 hours before the resurvey.
As in its defense of its previous failure to generate comprehensive assessments and care plans for other residents, Petitioner emphasizes that RESIDENT 1 of the second survey had a very severe Stage IV decubitus ulcer which had already reached the bone in her left hip to infect it, and she was already predisposed to losing a limb due to her diabetes and peripheral vascular disease. P. Br., 51; P. Reply, 31. Also according to Petitioner, the "natural priority in treating this resident was the resident's Stage IV decubitus ulcer." P. Br., 51. Therefore, Petitioner considered an "absurdity" the surveyor's opinion that the lack of care planning for the eschar on this resident's left heel might lead to more than minimal harm to her health. P. Reply, 31.
I believe I have already explained at length why I find this line of reasoning to be legally unacceptable under the regulation's requirements for Petitioner to prepare a comprehensive plan of care which would enable the resident to receive services for attaining or maintaining her highest practicable level of well-being. Here, there was also no care plan for this resident at the time of the second survey, even though Petitioner acknowledged her predisposition to losing a limb and the Stage IV decubitus ulcer in her left hip.
Petitioner argues also that its failure to note or prepare a care plan for a black eschar was harmless in fact, since Petitioner had already placed this resident's entire body on a state-of-the-art flexicare bed as treatment for her Stage IV decubitus ulcer. P. Reply, 31. Petitioner contends that the use of this bed was for providing "pressure relief, one of the primary treatments for pressure sores. . . ." Id. However, there is no adequate evidence supporting the intimation that the relieving of pressure would, by itself, cause the eschar or lesion to heal--especially when the resident was already 75 years old and suffering from diabetes mellitus, hypertension, arthritis, dementia, Parkinson's disease, urinary tract infection, Stage IV decubitus ulcers, among other problems. P. Ex. 123. The lack of healing was a risk specifically noted by the surveyor when addressing the significance of care planning for the black eschar. Tr. 442.
Finally, Petitioner defends on the basis that the regulation provided it with a total of 21 days to prepare a comprehensive plan (14 days after admission to assess and 7 days thereafter to generate the written plan). P. Br., 51; P. Reply, 31. Noting that this resident was not readmitted until December 6, 1995, Petitioner contends that it was still within its 21-day period for preparing a comprehensive care plan when the resurvey took place on December 19 and 20, 1995. Id.
One of the problems I find with this defense is that Petitioner does not acknowledge the existence of the black eschar on this resident and Petitioner denies the need to assess or address that condition in preparing a care plan even if the surveyor had observed it. There is no evidence or argument showing that on December 27, 1995, 21 days after this resident's admission, Petitioner would have prepared on its own initiative a comprehensive care plan addressing not only her most severe medical conditions, but also those lesser problems which are inhibiting her from attaining her highest practicable level of well-being.
More significantly, the regulatory language is cast in terms of "[n]o later than 14 days after the date of admission" for the completion of a comprehensive assessment, and "within 7 days after completion of the comprehensive assessment" for the creation of a plan of care. 42 C.F.R. § 483.20(b)(4)(i), (d)(2)(i)(emphasis added). A facility becomes fully responsible for the care and well-being of its residents on the day of their admission, not on the 14th or 21st day thereafter as suggested by Petitioner. Therefore, it would be legally incorrect to conclude that under no circumstances should a facility complete an assessment and prepare a care plan sooner if doing so would be appropriate and beneficial to a resident's care. Here, Petitioner should have developed a comprehensive care plan promptly--before December 27, 1995--to address RESIDENT 1's development of a black eschar on her left heel, her very severe Stage IV decubitus ulcer which had already reached the bone in her left hip to infect it, and her predisposition to losing a limb due to her diabetes and peripheral vascular disease.
FFCL 8: As established by the evidence concerning RESIDENT 1 of Survey 3, Petitioner continued to be out of substantial compliance with the requirements of 42 C.F.R. § 483.20(b) as of the third survey.
A. Analysis of the parties' evidence and arguments concerning the need to assess RESIDENT 1's movement of her leg while in the Bucks traction
For the third survey, which took place during February 1996, HCFA relies upon the survey findings concerning RESIDENTS 1, 5, and 12 to establish Petitioner's continued noncompliance with the assessment requirements of 42 C.F.R. § 483.20(b). HCFA Br., 34 - 40. I address below only HCFA's findings concerning Resident 1 of the third survey, because the relevant evidence is more than adequate for establishing Petitioner's continued failure to comply substantially with the assessment requirements as of February 1996.
For Resident 1, HCFA's relevant evidence involves the use of the Bucks traction, the development of a pressure sore, and a weight loss problem. Previous to the February survey, this resident had sustained a fractured hip. In late January, she was readmitted to Petitioner's long-term care facility following a hip replacement procedure.(35) This resident had a new prosthetic hip at the time of the third survey. She was assessed by Petitioner during early February 1996.
The surveyor testified that she began inquiring into the use of the Bucks traction for this resident after she saw that the leg which had received the hip replacement was in the traction device but the leg was not in a proper position. See HCFA Br., 35 (citing Tr. 679 - 686). The surveyor testified that the Bucks traction is supposed to be used to keep a limb straight and in proper alignment to promote healing. Id. However, the surveyor saw that this resident's leg was turned inward, with the weight of the traction device holding it in a position which could have resulted in damage to her hip. Id. The surveyor was told by the staff, and she personally observed, that this resident would not maintain a proper position in the Bucks traction because she wriggled or shifted on the bed. Id. According to the surveyor, Petitioner's staff members were not even able to tell her why the resident was in the Bucks traction or how to apply the traction properly.(36) Id. Therefore, the surveyor began asking for the assessment documents relating to the use of a Bucks traction for this resident. Id.
According to the surveyor, when she asked for the written assessment on the use of a Bucks traction for RESIDENT 1, Petitioner's staff failed to provide anything to her. Id. She found no assessment addressing the problem of the resident's wriggling or changing her position while in the Buck's traction. Id. After the surveyor had asked the staff to attend to this resident's improper position in the traction device, she asked that the physician be advised of the unsafe condition caused for this resident. Id. According to the surveyor, the physician discontinued the order for the Bucks traction the very next day. Id.
HCFA acknowledges that a "Falls RAP" submitted into evidence by Petitioner in this proceeding shows that a physician had ordered the use of a Bucks traction of five pounds for RESIDENT 1. HCFA Br., 35 (citing P. Ex. 145, at 6). However, HCFA relies on the absence of those types of assessments described by the surveyor, such as Petitioner's failure to mention in writing this resident's inability to remain properly aligned in the traction device. HCFA Br., 35. The HCFA surveyor noted Petitioner's failure to describe in writing the objective of the Bucks traction. Id.
In its defense, Petitioner cites the evidence it had introduced to show that its staff knew how to apply a Bucks traction properly, but that RESIDENT 1 was causing the misalignment of her leg by her own movements. P. Br., 61. Petitioner contends that the problem was "the resident did not remain in Bucks traction." Id. Petitioner contends also that HCFA's criticisms of its assessments were unreasonable, made in disregard of the "minimum requirements established by the regulations . . . the funding sources available to the facilities . . . [and] the staffing levels available to facilities." Id. Additionally, citing the testimony of one of its nurses, Petitioner asserts that the physician knew of this resident's failure to remain in the Bucks traction, but he decided to continue her in the device anyway. Id.
I find no credible evidence establishing that the attending physician was aware of RESIDENT 1's positioning problems. The evidence cited by Petitioner is as follows:
Q: [by Petitioner's attorney]: And I know you didn't talk to him personally, but what is your understanding of what the doctor's response was with regard to the fact that this individual was not maintaining proper traction?
A: [by Linda Kranz, R.N.]: The doctor knew that the resident was confused and would become agitated, would become restless. So I believe--and he did examine the resident, so I do believe that he did know that she wasn't complying with the traction.
Q: Do you remember a conversation being told to you that someone said the doctor was called?
A: Yes, I do.
Q: What did the doctor say?
A: A little traction is better than no traction.
Q: So it was his position that the small amount of time that she was able to remain in traction was what he wanted at this time?
A. He felt it would be beneficial.
Tr. 1493 (emphasis added)(cited in P. Br., 61 and 61 at n.26). Given the nature of the questions posed, the responses do not establish the existence of those facts suggested by Petitioner's arguments.
Petitioner's arguments and evidence also fail to address its own failure to generate the assessments required by law when it knew that RESIDENT 1 was moving her leg out of position after the Bucks traction had been applied. Under 42 C.F.R. § 483.20(b), Petitioner had the responsibility for generating the appropriate assessments. Contrary to what is suggested by Petitioner's arguments concerning the surveyor's disregard for the facility's fiscal resources or staffing levels, HCFA's determination under this regulation is not that Petitioner should have had a staff member remain at this resident's bedside at all times to return her leg to its correct alignment in the Bucks traction every time she moved it.
HCFA's determination of noncompliance is based on the undisputed fact that Petitioner failed to assess (and, therefore, was unable to plan appropriately for) this resident's tendency to move her leg in a manner which was not only defeating the potential salutary effects of the Bucks traction, but which, together with the weight of the traction device, might result in damage to her prosthetic hip joint. Such an assessment was obviously necessary and appropriate since this resident was in a Bucks traction because she had one hip replaced, and Petitioner's staff believed she was involuntarily moving her leg out of position due to confusion, disorientation, or agitation. See Tr. 682, 1493.
Since Petitioner does not dispute the surveyor's observation that the resident was not always in the proper position for the Bucks traction or the surveyor's opinion that the improper position could result in damage to this resident's hip joint, I deem the harm element of the noncompliance finding as having been established by HCFA. Inasmuch as assessments should lead to a plan for appropriate interventions, Petitioner's failure to assess this resident for her movements after she has been placed in the Bucks traction posed a potential for more than minimal harm to her.
Based on the surveyor's discovery of a pressure sore on RESIDENT 1's heel during the February 1996 survey, HCFA contends that this resident had sustained actual harm while in the Bucks traction. HCFA points to the MDS form completed one week before the survey, which states that this resident had no pressure sore during the preceding seven days. HCFA Br., 37 (citing P. Ex. 144, at 6). Additionally, HCFA relies upon the RAPs sheet of the preceding week, which states that the resident was not able to move herself in bed but was at risk for skin breakdowns and poor healing. HCFA Br., 37 (citing P. Ex. 145, at 7). It appears to be HCFA's theory that Petitioner had allowed the pressure sore on the resident's heel to develop (apparently developed during the one week between the completion of the RAPs assessment and the survey) because it knew that the resident was susceptible to skin breakdowns but failed to assess for her tendency to shift out of the proper position while she was in the Bucks traction.
Petitioner responds that the problem area on the resident's heel, whether a pressure sore or a blister, could not have developed more than a few hours before the surveyor's observation because this resident wore a type of hose (a Ted Hose) which needed to be removed for 20 minutes every shift. Petitioner contends that, if a sore or blister had developed many hours before the surveyor observed it, the care-giver would have noticed the problem during the preceding shift when removing the resident's Ted Hose. P. Br., 62.
Petitioner's defense is immaterial. Even the likelihood that the sore or blister had developed within a few hours preceding the surveyor's observation of it does not cure Petitioner's failure to assess the problem. It is wrong for Petitioner to suggest that, in RESIDENT 1's situation, there was no need to make assessments until a sore or blister became observable. The assessment should have been done for the resident's tendency to move her leg out of position while the Bucks traction is in use, in order to consider, for example, whether sores, blisters, or other harm were likely to occur but may be avoided.
However, I do not find reasonable HCFA's conclusion that Petitioner's noncompliance with the assessment requirements of 42 C.F.R. § 483.20(b) had caused actual harm (i.e., the pressure sore or blister on heel) to RESIDENT 1. This conclusion presupposes that, if a timely assessment had been done of the resident's tendency to shift position within the seven days between the surveyor's observation and the RAPs assessment of her inability to move independently, the resident would not have developed any sore or blister on her heel. This conclusion is speculative at best. There is inadequate evidence to support the assumption that, within that seven-day period, a plan of intervention could have been established and implemented with a successful outcome. Therefore, I reject HCFA's conclusion that Petitioner's failure to assess the resident's tendency to move out of position in the Bucks traction had caused actual harm to that resident. HCFA has proven only that Petitioner's failure to assess for this resident's movement problems placed her at risk for more than minimal harm.
B. Analysis of the parties' evidence and arguments concerning Petitioner's failure to assess for RESIDENT 1's weight loss problems
With respect to RESIDENT 1's weight loss problem described by HCFA, I find that Petitioner had failed to perform an assessment in accordance with the requirements of 42 C.F.R. § 483.25(b), and, as a result, this resident was placed also at risk for more than minimum harm.
HCFA points out that Petitioner's dietician acknowledged that she had incorrectly completed the MDS form to indicate no weight loss, when, in fact, this resident had lost a significant amount of weight. HCFA Br., 39 (citing Tr. 1274).(37) HCFA notes also that there was no RAPs assessment done of the weight loss as a result. HCFA Br., 39.
Petitioner does not dispute HCFA's observation that the MDS form completed for RESIDENT 1 during early February of 1996 indicated "0" weight loss even though she had lost more than 10 percent of her body weight since the previous November, when she weighed 124.4 pounds and was still residing at Petitioner's skilled nursing facility. See HCFA Br., 38. However, Petitioner suggests that there was no error made in indicating "0" weight loss since this resident was being readmitted to the facility. P. Br., 40. To Petitioner, the 12 percent weight loss this resident sustained elsewhere did not need to be indicated on the MDS form. Id.
Petitioner's defense of its mistake is invalid on its face. The MDS form does not ask where the weight loss had occurred. The assessment process is to enable the resident to receive services suitable to her needs. A nursing facility does not take on a resident only to care for the problems which developed in-house, as suggested by Petitioner's approach. Therefore, if an individual is admitted or readmitted by Petitioner with a significant loss of weight, Petitioner needs to note that fact on the MDS form, so that the appropriate RAPs may be triggered, and an appropriate care plan may be prepared and implemented by Petitioner. Petitioner's excuse for indicating "0" weight loss is clearly inconsistent with the assessment scheme established by the regulations.
Petitioner also does not refute HCFA's observation that this resident's weight loss was not evaluated on any of the RAPs forms it had generated. Instead, Petitioner notes that the weight loss was "identified" by the dietician in the nutritional assessment. P. Reply, 40 (emphasis in original). The evidence relied upon by Petitioner shows that the dietician was aware of the weight loss and had written down the weight corresponding to various dates. Id. at n.32.
I am not persuaded by Petitioner's evidence. Not only is the assessment requirement not met by the dietician's "identi-fication" of weight loss, Petitioner's evidence supports the conclusion that Petitioner was still doing its assessments haphazardly during February 1996 without understanding the purpose of the process. It is beyond cavil that the MDS should be completed accurately, so that the correct items may be triggered for further analysis on the RAPs instruments, and a care plan appropriate to addressing the analyzed problems may be formed. The MDS, RAPs documents, and the care plan need to be internally consistent under this framework.
Yet, what I continue to see are Petitioner's arguments that it was not placing its residents at risk because it was making assessments without the RAPs or the MDS or despite its having placed inconsistent information on those documents. Even though it had been cited for the same problem earlier,(38) Petitioner was still viewing the MDS form as nothing more than a piece of paper to be completed without regard for the accuracy of information it places on it. With respect to having inaccurately described RESIDENT 1's weight loss as "0" on the MDS form dated February 1996, Petitioner states, for example--
[s]ince this resident was a new admission/readmission to the facility, a new MDS was performed. Therefore, the improper coding of a "zero" for change in weight on the MDS did not result in the facility failing to assess the resident.
P. Reply, 40. These contentions clearly reflect the incorrect belief that a facility meets its assessment obligations to its residents under the federal regulations by merely filling out pieces of paper.
For the foregoing reasons, I conclude that, as of the February 1996 resurvey, Petitioner's methods for assessing its residents continued to fall far short of the federal requirements. Petitioner's ad hoc, self-serving, non-standardized assessment efforts placed its residents at risk for having appropriate interventions overlooked, for having care plans created that were incomplete or not fully appropriate to their needs, and for receiving services which did not enable them to attain or maintain their highest practical level of well-being. Therefore, RESIDENT 1 as well as other residents were still being placed at risk for more than minimal harm by Petitioner's assessment practices as of the February 1996 survey.(39)
FFCL 9: As established by the evidence concerning RESIDENT 1 of Survey 3, Petitioner continued to be out of substantial compliance with the requirements of 42 C.F.R. § 483.20(d) as of the third survey.
During the third survey, the surveyors found noncompliance with the comprehensive care plan requirements of 42 C.F.R. § 483.20(d) on the basis of 6 of the 14 resident samples. HCFA Ex. 11 at 14. In these proceedings, HCFA relies on RESIDENTS 1, 2, and 5 of this survey as examples. HCFA Br., 41 - 44. However, I do not find it necessary to proceed beyond RESIDENT 1's situation, as the facts surrounding her are sufficient for concluding that Petitioner remained out of compliance with the comprehensive care plan requirements.
HCFA's determination here is a logical extension of its findings concerning RESIDENT 1 under the comprehensive assessment requirements discussed above. Because this resident tended to twist her leg out of alignment while in the Bucks traction, and because the surveyor had observed a newly developed sore on the back of her left heel, HCFA takes the position that Petitioner should have prepared a revised care plan in order to institute interventions appropriate for addressing these newly developed problems. I agree with HCFA's general conclusion on the facts of this case.
Ordinarily, if a resident had developed problems during a short period of time before the surveyors' arrival, I would hesitate to uphold any resulting findings of noncompliance with the care plan requirements as well as with the comprehensive assessment requirements. The regulations require the facility to makes its assessments of the recently developed needs before developing a comprehensive care plan containing appropriate interventions. As discussed elsewhere in this decision, the facility should act promptly, as appropriate to the resident's needs, within the time allowed by the regulations.
In this case, however, Petitioner does not acknowledge any need to prepare a revised care plan for RESIDENT 1. P. Br., 50 - 51; P. Reply, 45 - 46. In response to HCFA's determination that Petitioner needed to plan for dealing with the newly developed problem on the resident's left heel, Petitioner argues instead about whether the area determined to be a pressure sore by the surveyor was something else which might have developed within 24 hours. In response to HCFA's determination that Petitioner needed to plan for dealing with this resident's tendency to twist her left leg while in the Bucks traction, Petitioner attempts to demonstrate that its staff knew how to apply a Bucks traction properly.
Petitioner's disregard of this resident's needs is further underscored by its erroneous argument that "a facility has 14 days to complete a comprehensive assessment of the resident and 21 days following that date to complete the care plan for the resident." P. Br., 51.(40) This argument is inapposite, since Petitioner has never shown by word or deed that it would assess or plan for this resident's tendency to misalign her leg while in the Bucks traction or the development of a sore (or sore-like problem) on her left heel.
Moreover, the "14 days plus 21 days" period perceived by Petitioner is incorrect. See P. Br., 51. As I have already noted in rejecting a similar time-line that Petitioner had offered to excuse its omissions for another resident (RESIDENT 1 of Survey 2), assessments for significant changes must be made "promptly" (42 C.F.R. § 483.20(b)(2)(iv)) and a comprehensive care plan must be developed "within 7 days after completion of the comprehensive assessment" (42 C.F.R. § 483.20(d)(2)(i)) (emphasis added). Consistent with the regulations' intent to protect and promote the health of residents, "within 7 days" clearly requires a facility to prepare a care plan in less than seven days where, as here, the resident's needs warranted it.
Petitioner's misunderstanding of the time periods allowed by regulation is further exacerbated by its mistaken belief that completion of the MDS form constitutes completion of the comprehensive assessment process. It argues incorrectly that--
a facility has 14 days in which to complete the MDS; 42 C.F.R. § 483.20(d)(2) . . . indicates that a comprehensive care plan must be developed within 7 days from the completion of the MDS.
P. Br., 51 at n.24. Petitioner should know that, within 14 days after a resident's admission, the entire initial comprehensive assessment process must be completed--not just the MDS form, which is an initial screening tool. Moreover, Petitioner is wrong in suggesting that the completion of the MDS form triggers the formation of a comprehensive care plan or that information contained on the MDS form would suffice for the formulation of a comprehensive care plan.
In this case, RESIDENT 1 was placed at risk for more than minimum harm by Petitioner's failure or refusal to prepare a care plan in a timely manner appropriate to her newly developed needs. There is no evidence that this resident was capable of stopping herself from turning her leg in the Bucks traction. Nor is there evidence that she could, on her own, make the pressure sore (or sore-like problem) on her left heel disappear. Even if Petitioner had been proceeding in accordance with the 21-day time-line it alleges to be applicable, by that time, this resident could have damaged her surgical site at her hip as a result of having misaligned her left leg repeatedly in the Bucks traction and the sore or sore-like problem on her left heel could have become much worse due to lack of intervention.
For the foregoing reasons, Petitioner was out of compliance with the requirements of 42 C.F.R. § 483.20(d) during the third survey.
FFCL 10: As established by the evidence concerning RESIDENT 7 of Survey 4, Petitioner continued to be out of substantial compliance with the requirements of 42 C.F.R. § 483.20(b) as of the fourth survey.
During the fourth survey conducted during March 1996, the surveyors found that Petitioner continued to remain out of compliance with the assessment requirements (Tag F-272). HCFA adopted this conclusion and relies on the survey findings concerning RESIDENT 7 for support. For the reasons which follow, I uphold HCFA's determination on Petitioner's continued noncompliance with 42 C.F.R. § 483.20(b).
According to HCFA, the inquiry into RESIDENT 7's assessment records was prompted by a surveyor's observation that this resident, a long-term diabetic,(41) had a dark purple bruise on the middle toe of her left foot and a pressure sore on her left lateral malleolus.(42) HCFA Br., 50. The records provided by Petitioner show that the nurses had written in their notes that this resident had a "dark purple bruise on the end of middle toe." But the surveyor found no written assessment by Petitioner concerning the possible causes for the changes on the resident's foot, what the effects of those changes may be, or what nursing intervention may be appropriate. See HCFA Br., 50 - 51. However, the surveyor did find a note by the resident's physician stating that he may need to amputate the resident's toe. HCFA Br., 50 (citing HCFA Ex. 15, at 4 - 6).
In reviewing the relevant records, the surveyor determined that written assessments should have been done by Petitioner to address also the decreased circulation in this resident's foot. See HCFA Br., 51. For example, there was no documentation or assessment of the resident's pedal pulses, even though a March 2, 1996 document generated by Petitioner's staff stated, "2, 3, and 5 left foot discolored and swollen." The surveyors thought that Petitioner should have done an assessment of the resident's decreased circulation because, not only was peripheral vascular problem a known side effect of a medication being administered to this resident in excess of the recommended dosage,(43) this resident was also a long-term diabetic. Id. (citing Tr. 816, 832). Long-term diabetics often have peripheral profusion problems. Id.
As for the pressure sore on the resident's ankle, the surveyor determined that it was at Stage II on the outside, and Stage III in the center. HCFA Br., 51 (citing Tr. 818).(44) The surveyor found that, on another occasion, a nurse noted a decubitus ulcer (or pressure sore) on the resident's ankle but stated only, "leg rotates out when in bed and placed pressure on area." HCFA Br., 51 - 52 (citing Tr. 818). However, the surveyor found no assessment for the cause of the pressure sore or for whether the leg should be repositioned and observed daily. Id. Consequently, Petitioner failed to prepare an appropriate care plan addressing these problems. Id.
To further support the surveyor's findings and conclusions concerning the absence of the relevant assessments, HCFA analyzed also the documents introduced by Petitioner at the hearing. HCFA pointed out that the only assessment documents of record for RESIDENT 7 are dated February 29, 1996, 19 days before Petitioner was surveyed for the fourth time for compliance with 42 C.F.R. § 483.20(b). The quarterly MDS sheet of that date shows no ulcers or pressure sores and it makes no mention of a discolored foot. HCFA Br., 52 (citing P. Ex. 154). The RAPs sheets completed the same day also do not mention the existence of any pressure sores, though they show that "pressure sore" has been triggered and Petitioner noted in response that this resident lacked mobility in bed and was incontinent of bowel and bladder. P. Ex. 155. As HCFA noted correctly also, there is nothing in the RAPs sheets discussing the left foot discoloration or peripheral vascular disease. HCFA Br., 52 (citing P. Ex. 155).
Petitioner defends against the absence of assessments for the pressure sore observed by the surveyor on grounds that:
the type of ulceration described by the surveyor is one which would occur very quickly in the life of a diabetic. Therefore, to not have reflected on this MDS [dated February 29, 1996] is not surprising since the facility has 14 days to complete a significant change identified by a change in the resident's condition. The MDS assessment related to this specific condition would not be due.
P. Reply, 52. Accordingly, I need to remark, once again, on Petitioner's apparent disregard for the resident's well-being and the misreading of the regulation which underlies Petitioner's arguments.
Previously, I had rejected similar propositions made by Petitioner for RESIDENT 1 of the second (December 1995) survey (that a black eschar on this resident's heelmay have developed within 24 hours before the surveyor observed it) and for RESIDENT 1 of the third (February 1996) survey (that a pressure sore or blister could not have appeared on this resident's heel for more than a few hours before the surveyor had observed it). I had also rejected Petitioner's incorrect interpretations of the
regulatory deadlines when it interposed them for RESIDENTS 1 and 2 of the second (December 1995) survey and for RESIDENT 1 of the third (February 1996) survey.
Here, in the fourth survey, even if I were to accept as true that RESIDENT 7's ankle had shown no pressure ulcer when Petitioner completed its assessments on February 29, 1996, I cannot believe that a pressure ulcer could have appeared out of nowhere as a Stage II wound on the outside and a Stage III wound on the inside just when the surveyors arrived on site to make their observa-tions. Petitioner's arguments, plus the seriousness of the pressure sore on the day of the survey, begs the question of whether any staff member was paying serious attention to the condition of this resident's body after Petitioner wrote on its RAPs sheet dated February 29, 1996 that pressure sore was a "trigger." Moreover, if Petitioner truly believed that pressure sores of the type observed on RESIDENT 7 could develop very quickly in a diabetic, only the most callous disregard for this resident's health could have prompted the legally incorrect defense that a facility was entitled to use 14 days to complete an assessment for significant changes in a resident.
Under Petitioner's approach, the pressure sore on RESIDENT 7's ankle could have progressed rapidly beyond Stages II and III before Petitioner got around to assessing it or devising an appropriate plan of care. Fortunately for RESIDENT 7 and others like her, the regulation requires long-term care facilities to assess "promptly after a significant change in the resident's physical or mental condition. . . ." 42 C.F.R. § 483.20(b)(4)(iv) (emphasis added). Therefore, Petitioner cannot avail itself of a period of time which is inappropriate to the exigencies of the circumstances.
I reject also Petitioner's argument that it should have been found in compliance with the assessment requirements because RESIDENT 7 had not been placed at risk for any harm by Petitioner. Underlying this defense is Petitioner's evidence that the resident had been experiencing peripheral vascular problems for many years before entering its skilled nursing facility (Tr. 843 - 844); that a vascular study done shortly after the March 1996 survey showed virtually no circulation remaining in her left leg (Tr. 844; P. Br., 72); that Dr. Metwally was of the opinion that this resident's leg should have been amputated if gangrene had set in and the condition of the leg had worsened (P. Reply, 52).(45) Petitioner contends that because it had administered the Gabapentin medicine recommended by a physician at a pain clinic to manage this resident's pain, the circulation in her leg had improved, and the decubitus ulcer on her toes had healed. P. Br., 72.
Again, the above defense is too reminiscent of the rationale provided by Petitioner for having indicated no significant weight loss on the MDS form for Resident 1 of the third (February 1996) survey: i.e., the residents' problems began before Petitioner admitted them. The defense encompasses also its excuse for having failed to assess for the seizure or seizure-like episode experienced by a resident whom Petitioner considered to be a "hospice patient" (Resident 2 of the second (December 1995) survey). As I have already explained in the context of those other residents, there is no logical or legal support for these lines of reasoning.
Petitioner's reliance on RESIDENT 7's improvements to claim harmless error suffers from other flaws as well. The evidence relied upon by Petitioner does not show that it knowingly brought about the improvements. At best, Petitioner has shown that a family member's objections to surgery and the surgeon's fear of lawsuits enabled this resident to keep her left leg from being amputated after the March 1996 survey. Tr. 1373; P. Reply, 52. Then, much to Petitioner's surprise, the pain medication Gabapentin caused the circulation in the resident's left leg to improve and the ulcer sores on that leg to heal, at some unspecified time after the March survey. P. Reply, 52; P. Br., 72.
Without doubt, Dr. Metwally obtained a vascular consultative evaluation after the March survey and the resident's medication level was adjusted on the day of the survey.(46) However, the improvements attained by the resident after Petitioner and her doctors took actions responsive to the survey findings cannot inure to Petitioner's benefit as proof of its compliance with the assessment requirements of 42 C.F.R. § 483.20(b). Petitioner had an obligation to take certain actions timely, in the manner specified by the regulation. Petitioner cannot exonerate itself with the reasoning that the resident improved despite Peti-tioner's failure to follow the regulatory mandates. At the very least, Petitioner's failure to perform timely and complete assessments responsive to RESIDENT 7's deteriorating condition as of the March 1996 survey had placed this resident in jeopardy of further decline through oversight or neglect of her needs. The surveyors intervened and, subsequently, this resident's condition improved.
FFCL 11: Petitioner was deemed to have ended its noncompliance with program requirements on March 21, 1996, pursuant to its attestations.
By the time the fourth survey of Petitioner was completed, there came into existence a policy under which, for certain levels of deficiencies, the state surveying agency was authorized to accept a facility's attestation that it had resumed compliance with all program requirements. Jt. Ex. 1 at 51 - 53. Under this policy, the State surveying agency had the discretion to waive any on-site resurvey to verify the correction of deficiencies. Id. By notice dated March 21, 1996, the state surveying agency provided Petitioner with the option of completing certain forms to attest to its correction of those deficiencies found during the fourth survey. Id. at 51. Petitioner completed those attestation forms, and the state surveying agency waived further surveys of Petitioner pursuant to the cycle that began with the annual survey of Petitioner on December 21, 1995. Accordingly, Petitioner was deemed to have resumed compliance with all program requirements on March 21, 1996.
FFCL 12: Because Petitioner was out of compliance with program requirements during four surveys (FFCLs 1 through 11 above), Petitioner must, as a matter of law, pay a CMP as follows:
A. the $50 per day assessed by HCFA for the periods covered by Survey 2 (December 20, 1995 through February 22, 1996) and Survey 4 (March 19 and 20, 1996) and
B. at least $50 per day of the $300 per day rate HCFA had assessed for the periods covered by Survey 1 (November 16 through December 19, 1995) and Survey 3 (February 23 through March 18, 1996).
(Alternatively, FFCL 13: HCFA had a basis for imposing at least $50 per day for the period from November 16, 1995 through March 20, 1996.)
Based on its determination of Petitioner's noncompliance during the four surveys, HCFA imposed a CMP remedy at these rates:
-- at the rate of $300 per day for a portion of the period covered by the first survey (November 16 through December 19, 1995);(47)
-- at the rate of $50 per day for the entire period covered by the second survey (December 20, 1995 through February 22, 1996);
-- at the rate of $300 per day for the period covered by the third survey (February 23 through March 18, 1996); and
-- at the rate of $50 per day for the period covered by the fourth survey (March 19 and 20, 1996).(48)
I conclude that, where, as here, the preponderance of the evidence presented under the "basis issue" supports the conclusion that Petitioner was out of substantial compliance with one or more Medicare participation requirements, and HCFA has decided to impose a CMP against Petitioner for the period of noncompliance, then Petitioner becomes liable as a matter of law for the payment of at least $50 per day in CMP for each day of noncompliance.
The regulations provide that the CMP may begin as early as the date that the facility was out of compliance and it will continue until the facility achieves substantial compliance. 42 C.F.R. § 488.440(a), (b). In this case, HCFA used November 16, 1995 as the beginning date, even though noncompliance had been determined to have been in existence as of September 21, 1995. The end date was also set properly at March 20, 1996, the day before Petitioner was determined by HCFA to have resumed compliance with all program requirements.
HCFA's choice of alternative remedies is not an "initial determination" subject to challenge in the administrative hearing and appeals process. 42 C.F.R. § 498.3(d)(11).(49) The regulation at 42 C.F.R. § 488.438(e)(2) expressly precludes an administrative law judge from reviewing HCFA's exercise of its discretion to impose a CMP in addition to, or instead of, another remedy. 42 C.F.R. §§ 498.3(d)(11), 488.438(e)(2). Therefore, even though Petitioner has made many arguments in its briefs concerning why HCFA should not have decided to impose a CMP remedy against it, I will not consider those arguments.
Where an administrative law judge finds that HCFA had a basis for imposing a CMP, he or she may not reduce the CMP amount to zero. 42 C.F.R. § 488.438(e). Under the regulations, the lowest rate of CMP which may be imposed is $50 per day. 42 C.F.R. § 488.438(a)(2). Therefore, it is not necessary for me to analyze whether the $50 per day rate is reasonable on the facts of this case.
Accordingly, I uphold HCFA's determination to impose $50 per day in CMP for the periods covered by the second survey (December 20, 1995 through February 22, 1996) and the fourth survey (March 19 and 20, 1996). For the same reasons, Petitioner is obligated to pay at least $50 per day of the $300 per day CMP assessed by HCFA for the periods covered by the first survey and the third survey.
FFCL 14: HCFA erred in determining that a $300 per day CMP rate was reasonable by--
A. relying materially on the Scope and Severity level rating assigned by the State surveyors to Petitioner's deficiencies and
B. relying materially on a formula prepared by the State of Michigan which correlated specific Scope and Severity levels with set daily rates of CMP.
At bottom, the issue concerning the reasonableness of the CMP amount relates to only the extra $250 per day HCFA has assessed against Petitioner for the 59 days covered by the first and third surveys.
The regulations specify the criteria to be considered in determining whether the amount of the CMP is reasonable. They are:
-- the facility's history of non-compliance, including repeated deficiencies;
-- the facility's financial condition;
-- the facility's degree of culpability;
-- whether a facility's deficiencies constitute--
(1) no actual harm with a potential for minimal harm,
(2) actual harm that is not immediate jeopardy, or
(3) immediate jeopardy to resident health or safety;
-- whether a facility's deficiencies
(1) are isolated,
(2) constitute a pattern, or
(3) are widespread; and
-- other factors such as the relationship of the one deficiency to other deficiencies resulting in compliance.
42 C.F.R. §§ 488.438(f), 488.404, as incorporated by 42 C.F.R. §§ 498.3(b)(12), 488.438(e)(3).
A. The evidence on how the $300 per day rate was calculated by HCFA with use of the "G" Scope and Severity level determined by the surveyors, and with use of Michigan's formula correlating the "G" level with the predetermined $300 per day amount
HCFA contends that the $300 per day rate is reasonable for the 59 days covered by the first and third surveys because the surveyors found the existence of deficiencies at the "G" level ("isolated deficiencies with actual harm," according to HCFA) during those surveys. HCFA Br., 123. It has introduced considerable evidence to establish the correlation between the "G" level, the State agency's formula, and the $300 per day rate.
On the survey reports for September 1995 and February 1996, the abbreviation of "SS=G" appears with "F 272," "483.20(b) STANDARD: RESIDENT ASSESSMENT." HCFA Ex. 3 at 13; HCFA Ex. 11 at 7. Based on the evidence of record and the explanations of counsel, this "SS=G" abbreviation means "Scope and Severity Level = G."
A chart placed into evidence by HCFA shows on the horizontal axis "SCOPE" and on a vertical axis "SEVERITY/HARM." HCFA Ex. 23 at 3. On this "Scope and Severity" chart, "G" corresponds to "isolated" and "actual harm that is not immediate jeopardy." Id. "Actual harm that is not immediate jeopardy" is, in turn, defined as "deficient practice led to a negative outcome that has compromised the resident's ability to maintain and/or reach his/her highest practicable physical, mental, and/or psychosocial well-being." Id. The definition for "[i]solated" includes "[o]ne or a very limited number of residents affected . . . ." Id.
HCFA submitted into evidence also the written declaration of Beth Bacon, the State agency official who made the recommendation to impose the CMP at the $300 per day rate. HCFA Ex. 21. She stated that she had relied on the various levels of citations, such as "E" or "G," from each survey in deciding whether to forward to HCFA a recommendation concerning the imposition of a CMP and at what amount. HCFA Ex. 21 at 2 - 4. She stated also that, in making these decisions, she was following the State agency's policy on such matters. Id. As an attachment to her declaration, there appears a printed chart showing, for example, that a "mandatory" CMP of "$300/day" must be imposed for a citation level of "G" incurred by a "historically compliant" facility. HCFA Ex. 21 at 11. The chart shows no lesser amount of CMP for the "D," "E," or "F," citation levels. Id.
Beth Bacon's deposition, also in the record as the parties' Joint Exhibit 1, makes clear that the Scope and Severity levels she used were set by the surveyors and came from the survey reports. Jt. Ex. 1 at 6 - 8. She did not do any evaluation of these scope and severity levels. She testified, for example, "[w]hen a survey report is given to me[,] I look for the highest level of noncompliance and then I go to this grid looking for the same level . . . ." Jt. Ex. 1 at 8.
HCFA introduced the testimony of its employee, Delores Debro, who drafted the CMP notice letter to Petitioner, dated February 26, 1996, issued by HCFA. HCFA Ex. 10. With much leading by HCFA's counsel, Ms. Debro indicated that she used the $300 per day rate because there was a "G" scope and severity level. Tr. 553,(50) 559. She stated also during cross-examination that she generally follows the recommendation of the State surveying agency, which specified $300 per day for a level "G." Tr. 564. She also did not remember or believe that she had ever determined to impose a CMP for HCFA at a level of "D" or "E." Tr. 572.
With respect to the portion of HCFA's February 26, 1996 notice letter which imposes a CMP of $300 per day for Survey 3, HCFA showed that the State agency had made no recommendation for HCFA to do so. Tr. 554 - 56. However, Ms. Debro's testimony indicates that she prepared that HCFA notice letter as if there had been a State recommendation to impose the CMP for Survey 1 as well as for Survey 3. Tr. 581 - 82.(51) Ms. Debro did not realize at the time she prepared HCFA's notice letter that the state had not yet recommended the imposition of any CMP for the third survey.(52) Tr. 554 - 56, 581 - 82.
HCFA elicited testimony also from Rita Wilson, the HCFA official who signed the agency's February 26, 1996 letter. HCFA's notice letter states, inter alia, that the $300 per day CMP was being imposed because the September 1995 survey had found that "the most serious deficiency in your facility to be isolated deficiencies that constitute actual harm that is not immediate jeopardy whereby significant corrections were required (G)." HCFA Ex. 10 at 1.
Ms. Wilson testified at the hearing that, prior to issuing the CMP notice letter to Petitioner, the tasks she had performed were as follows:
I reviewed the [HCFA notice] letter, compared it with the 2567s [i.e., the survey reports], the grids that were submitted by the state agency, to see that the citations were correct, and also that the level of the civil money penalty was appropriate and the effective dates were correct. And I sign it . . .
Tr. 588. HCFA especially emphasized in its posthearing brief the portion of Ms. Wilson's testimony establishing her use of "grids that were submitted by the state agency" (Tr. 588). HCFA Reply, 68.
Even more significantly, in answer to HCFA counsel's question, "[w]hy did you agree with the $300 per day civil money penalty?", Ms. Wilson testified:
[b]ecause, as I said earlier, I work with the State of Michigan, and HCFA has developed a grid which allows a civil money penalty at the Category D level . . . of harm, and that civil money penalty can be anywhere from 50 to 3,000 a day.
But we work with the State of Michigan state plan, which limits the CMP to start at 300 a day at the G level. And it's a specific designation of 300 for the G level.
Tr. 589. When I asked her to explain how the "federal grid" coordinates with the Michigan "grid," Ms. Wilson testified that the "federal grid" has more options and an amount range of up to $3,000 per day which may be applied at the "D" level. Tr. 589 - 90. However, she proceeded to state also:
[a]nd we worked with the Michigan state plan, with their recommendation to start the CMP at the G level, at $300 per day. And we honor that plan, but we have the option of still following the HCFA guidelines.
Tr. 590.
At minimum, the above body of documentary and testimonial evidence introduced by HCFA establishes its material reliance on the "G" scope and severity level rating assigned by the surveyors to their findings of deficiencies, as well as HCFA's material reliance on the outcome directed by the State's formula. If all references to the "G" rating by the surveyors and the State-generated formula were eliminated from the record, there would remain no cogent explanation of how HCFA decided upon $300 per day as opposed to a lesser or greater CMP rate between the permissible range of $50 to $3,000 per day.(53)
B. The legal errors made by HCFA in using a scope and severity level
After having introduced the foregoing body of evidence to show how it had arrived at the $300 per day rate, HCFA contends that I must affirm the reasonableness of the $300 per day rate because the "scope and severity of a deficiency is not appealable except to the extent that a facility can show a deficiencies [sic] was at the A, B, or C level, which is substantial compliance." HCFA Br., 123 at n.74. HCFA contends also that I must affirm the $300 per day rate because HCFA has the unreviewable discretion to select any amount from the lower range ($50 to $3000 per day) provided by 42 C.F.R. § 488.438(a) when there is no finding of immediate jeopardy to residents. HCFA Br., 123 at n.75.
I find HCFA's legal conclusions to be erroneous. Under the relevant regulations, there is no scope and severity grid, and the surveyors are not supposed to be applying any scope and severity scale to rate the deficiencies found during surveys. I take note that the preamble of the federal regulations specifically refers to the elimination of a scope and severity scale in the performance of surveys:
[w]e are not adopting the use of scope and severity scales to identify deficiencies because, as described below, the Act imposes limitations that make it impractical. However, we are adopting substantial compliance as the standard of performance to which providers will be held. This is consistent with the intent of the Act, and will accomplish much of what the advocates of scope and severity scales claimed that the scales would accomplish. Although the thrust of nursing home reform was to codify a system of nursing home regulation that is outcome oriented, the Congress enacted a number of requirements that simply do not lend themselves to an outcome analysis. Moreover, the Act does not always lend itself to an analysis of whether the resident population as a whole was treated properly which, in our view, would be essential to a workable scope index.
Other requirements in the Act, as some commenters pointed out, focus on a facility's duty with respect to each resident and not its duty to perform in a certain fashion for the bulk of all individuals in residence. 59 Fed. Reg. 56,226 (emphasis added).
For the limited purpose of determining which, if any, remedy to impose for deficiencies found during a survey, HCFA is authorized by the regulations to consider the prevalence of a facility's deficiencies and the degree of their impact on residents. 42 C.F.R. §§ 488.404(b), 488.408. The regulations group the available alternative remedies into three groups. Id. A grid appears in the Federal Register to illustrate how the three groups of remedies correspond to the prevalence of deficiencies and the degree of their impact on residents. 57 Fed. Reg. 56,183.
However, contrary to what has been suggested by HCFA, there are no "D" through "L" levels appearing on the grid published in the Federal Register to explain the regulations at 42 C.F.R. §§ 488.404(b) and 488.408 in terms of when HCFA may choose from these three categories of remedies. HCFA Ex. 23.(54) Moreover, in the portion of the preamble explaining 42 C.F.R. § 488.404 ("Factors to be considered in selecting remedies"), the Secretary has stated the following:
[i]n the final rule, we have removed the scope and severity scales, as such, and have replaced them with a set of criteria that must be used (should a decision be made to impose alternative remedies at all) to select an enforcement remedy. Specifically, while the enforcement scheme in this final rule is conceptually the same as the former scope and severity scales, it differs from that approach in numerous significant ways:
-- It leaves to the judgment of both HCFA and the States whether to impose alternative remedies at all, regardless of the seriousness of a facility's deficiencies.
59 Fed. Reg. 56,173 (emphasis added).
It is true that I cannot review the choice of remedies made by HCFA to correct proven noncompliance determinations. 42 C.F.R. § 488.408(g)(2). However, only HCFA's selection of a particular remedy (e.g., CMP versus a Denial of Payments for New Medicare Admissions) is non-reviewable. Once HCFA has selected CMP as the remedy to impose, HCFA must then determine the appropriate amount of the CMP based on the factors listed in 42 C.F.R. §§ 488.438(f) and 488.404 as incorporated by 42 C.F.R. §§ 498.3(b)(12) and 488.438(e)(3). I have the authority to review whether HCFA reached a reasonable amount determination by use of those factors as applied appropriately to the facts of this case. Id.
HCFA's use of the "G" scope and severity level to set a particular CMP rate is not within the protective sphere of its discretion to select a particular type of remedy to impose. Moreover, the evidence introduced by HCFA makes clear that the "G" scope and severity level determination had been made as part of the surveys themselves, and not by Ms. Bacon, the State agency official responsible for recommending the selection of remedies and CMP amounts to HCFA. HCFA Ex. 21;(55) Jt. Ex. 1 at 6 - 8. The fact that the "G" scope and severity level determination was made at the surveyors' level is also confirmed by the testimony of another witness called by HCFA, Howard Schaeffer. Mr. Schaeffer supervised a team of surveyors who inspected health care facilities. Tr. 58. His duties did not include recommending remedies or CMP amounts to HCFA. Tr. 58. However, his job as a supervisor of surveyors included making sure "the scope and severity [is] reasonably accurate for the deficiency. . . ." Tr. 72. He testified about the changes which were made to the scope and severity findings on the survey report pursuant to HCFA's October 1995 instructions for State survey agencies "to review reports and if necessary amend scope and severity rating that had been given prior to that time." Tr. 64 (referring to differences between HCFA Ex. 1 and 3).
There is no evidence to support HCFA's post hoc intimation that the "G" scope and severity level might have been determined independently by its own officials while performing its unreviewable process of selecting a particular remedy. Nothing said on direct or cross-examination by Ms. Debro or Ms. Wilson could lead to this conclusion.
For these reasons, HCFA's material reliance on a "G" scope and severity level to set the CMP rate at $300 per day was wrong as a matter of law and the result attained through its material reliance on the "G" scope and severity level does not establish the reasonableness of the CMP rate in controversy.
C. Legal error made by HCFA in using the Michigan formula
In several rulings issued in other cases, I had noted problems with the Michigan chart or formula which was also used in this case. In those other cases, the Michigan chart or formula appeared as an attachment to "Michigan Bulletin 95-03." In one of those cases, I stated, for example:
a grid contained in Attachment One of Michigan Bulletin 95-03 (HCFA Ex. 7 at 12 - 14) provides for no CMP below the amount of $300 per day,(56) whereas the federal regulations specify that $50 per day is the minimum CMP amount that may be imposed (42 C.F.R. § 488.438(a)). Moreover, Michigan Bulletin 95-03's grid at Attachment One sets fixed daily rates of CMPs, whereas the federal regulations allow for choosing between two ranges of rates without specifying which specific rate must be imposed. 42 C.F.R. § 488.438. For "non-immediate jeopardy" cases, the Michigan grid sets specific rates ranging from $300 to $2000 per day using only the criteria of "Historically Compliant" versus "poor performer" to differentiate the daily CMP rates for the same level of citations.(57) In contrast, the federal regulation applicable to "non-immediate jeopardy" cases does not establish any fixed rates but requires the setting of the CMP amount to be within the range of $50 to $3000 per day, based on considerations of the facility's compliance history, as well as its financial condition, its degree of culpability, and other factors such as the relationship between deficiencies (42 C.F.R. §§ 488.438, 488.404). . . . In addition, the federal regulation's requirement that increments of $50 be used (42 C.F.R. § 488.438(a)) does not appear anywhere in the Michigan Bulletin 95-03's Attachment One. [The Michigan formula uses increments of $100.]
Ruling Denying Pet.'s Mot. to Set Aside HCFA's Imposition of Remedies and Directives to Parties, at 7 - 8, Presbyterian Village of Redford v. HCFA, Docket No. C-97-076 (May 22, 1997).
In discussing how the CMP amount should be determined under the federal criteria, the preamble to the regulation now codified as 42 C.F.R. § 488.438 states in relevant part:
Many commenters suggested requiring that civil money penalties be imposed at specific scope and severity levels.
Response: We do not accept these recommendations.
. . . .
While the Secretary could implement a policy by which each specific degree of seriousness would automatically precipitate civil money penalties at specific amounts, such a policy would undermine the Secretary's flexibility to tailor enforcement action to the exact nature of deficiencies in specific facilities. As a matter of policy, we will limit the use of civil money penalties to the more serious deficiencies. Civil money penalties are included as a remedy choice when the seriousness of the deficiencies is such that Category 2 or Category 3 remedies would be applicable, as specified in § 488.408, Selection of remedies.
59 Fed. Reg. 56,205. Thus, as I have previously noted, HCFA may only consider the seriousness and prevalency of deficiencies to determine whether a CMP and/or another alternative enforcement remedy should be imposed under 42 C.F.R. § 488.408. A particular Scope and Severity level cannot be used to trigger a specified daily rate of CMP
The Michigan grid contains approaches and results that are irreconcilable with those indicated by the federal regulations. Therefore, HCFA's material reliance on the Michigan grid to determine the $300 per day amount was erroneous as a matter of law. The result attained through its material reliance on the Michigan grid does not prove the reasonableness of the $300 per day rate.
FFCL 15: HCFA's evidence concerning its inquiry into Petitioner's financial condition is not sufficient for establishing the reasonableness of the $300 per day rate.
I address next the question of Petitioner's financial condition as it relates to HCFA's argument that the $300 per day amount is reasonable. For purposes of my discussion in this section, I will disregard the improper methods by which the $300 per day rate was attained by HCFA with use of the "G" scope and severity level and the Michigan formula.
HCFA contends that it had considered the facility's financial condition and concluded that it would be able to afford the CMP being assessed. Its evidence consists of the testimony of its employee, Delores Debro, concerning what she did. She testified that, in order to obtain the financial information, she spoke with an unidentified individual who answered the telephone for the entity contracted by HCFA to handle Medicare claims. Tr. 557, 575 - 76. According to Ms. Debro, she made the telephone call and asked the individual who answered if Petitioner could afford to pay a $300 per day in CMP. Tr. 557. According to her testimony, her question elicited only the response, "[y]es." Id.
She could not identify the individual who provided this answer by name or title. Tr. 575 - 76. She never analyzed any financial data or information herself and she did not ask what documents had been reviewed by the person who answered the telephone.
On the basis of the foregoing evidence, HCFA contends that the rate of the CMP is reasonable. HCFA argues that I am without the authority to review its process for obtaining financial data in this or other CMP cases. It cites my decision in Capitol Hill Community and Rehabilitation, DAB CR469 (1997). HCFA Br., 118.
HCFA has misinterpreted and misapplied my decision. What I stated was that, because Capitol Hill failed to challenge the reasonableness of the CMP amount, therefore, I did not have the authority to review HCFA's procedures for soliciting financial information. Capitol Hill, id. at 6 - 7, aff'd, DAB No. 1629 at 4 - 6 (1997). In this case, Petitioner does indeed contest the reasonableness of the CMP amount. HCFA itself contends that a reasonable CMP amount had been determined following its evaluation of Petitioner's financial condition. Therefore, the method used by HCFA in making the financial assessment required by regulation is reviewable and it has significant bearing on the amount of weight to be accorded the resulting opinions of Ms. Debro.
Clearly, Ms. Debro's testimony is fraught with problems. Even HCFA's counsel conceded that, "whether their level of consideration was the best is to be questioned . . . ." Tr. 1583. By testifying that she had a two-sentence telephone exchange with an individual whom she did not know by name or job title, Ms. Debro has not shown the receipt of accurate (or even facially reliable) information on the question of whether Petitioner was able to pay a CMP of $300 per day for a 59-day period.
Nor does Ms. Debro's testimony indicate that HCFA has complied with the intent of the Act or the regulation, which contemplates allowing the facility an opportunity to "furnish the information it believes appropriately represents its financial status." 59 Fed. Reg. 56,204. The regulation did not list the documents which must be examined by HCFA in evaluating the facility's financial condition "because these factors are unique for each facility." Id. Here, nothing of record suggests the existence of any "unique factor" which might have made it appropriate for Ms. Debro to form an opinion on the basis of another opinion rendered by an unidentified individual with (or without) the use of information not described to her.
For these reasons, I cannot accept HCFA's consequent reliance on Ms. Debro's opinion concerning Petitioner's financial condition as valid or persuasive support for its argument that a $300 per day CMP is reasonable.
FFCL 16: Because HCFA had misapplied the regulatory factors in calculating and supporting the $300 per day CMP amount, I must determine what would constitute a reasonable CMP amount to be collected from Petitioner for the 59 days covered by Surveys 1 and 3.
For the reasons already discussed above, I cannot reduce the CMP amount for the first and third surveys to zero. Therefore, I must now make a de novo determination on whether $50 per day is reasonable or whether an amount over $50 per day should be set based on the relevant evidence of record.(58)
Because HCFA alleged that the $300 per day rate reflected only its consideration of Petitioner's financial condition and the scope and severity level of Petitioner's deficiencies, the only evidence of significance in this record concerns those two matters. Even though other factors may be considered under the regulations when setting the CMP rate, the evidence on the other factors is sketchy because Petitioner did not take issue with HCFA's failure to apply them when setting the $300 per day rate. For this reason, pursuant to my authority under 42 C.F.R. § 488.438(e), I will determine a reasonable CMP rate on the basis of the available evidence relevant to the "seriousness of deficiencies" factor listed at 42 C.F.R. § 488.404(b) and to the "financial condition" factor listed at 42 C.F.R. § 488.438(e)(2).
FFCL 17: Under the "seriousness of deficiencies" factor listed in 42 C.F.R. § 488.404(b) (as incorporated by 42 C.F.R. § 488.438(f)(3)), a CMP of $300 per day for the 59 days covered by Surveys 1 and 3 is reasonable based on:
A. the widespread nature of Petitioner's noncompliance with 42 C.F.R. § 483.20(b) during the period covered by the first survey;
B. the more than minimal risk (but no actual harm) to residents caused by Petitioner's noncompliance with 42 C.F.R. § 483.20(b) during the period covered by the first survey;
C. the pattern indicated by Petitioner's noncompliance with 42 C.F.R. § 483.20(b) during the period covered by the third survey;
D. the more than minimal risk (but no actual harm) to residents caused by Petitioner's noncompliance with 42 C.F.R. § 483.20(b) during the period covered by the third survey; and
E. a comparison with the other CMP amounts which have been imposed or upheld on administrative review.
I find that during the initial survey, Petitioner's noncompliance with the assessment requirements of 42 C.F.R. § 483.20(b) was widespread.(59) During that initial survey, surveyors found assessment deficiencies in 11 out of the 11 residents' records they reviewed. HCFA Ex. 3 at 14. Even on the basis of the various residents used by HCFA as examples during the hearing process, HCFA had proven the validity of its noncompliance finding. Additionally, the nature of the underlying deficiencies and Petitioner's rationale for its actions which I noted above support the conclusion that Petitioner's noncompliance with the assessment requirements was widespread.
In discussing RESIDENT 1 of survey 1, I had noted that the surveyor's conclusion of "negative outcome" on September 21, 1995 could not be properly attributed to Petitioner's failure to complete a complete assessment of her a few days prior, on September 19, 1995. To conclude that a negative outcome had been caused to this resident by the assessment deficiencies would require assuming, without adequate factual foundation, that a proper assessment would have resulted in the preparation of a care plan containing interventions which would have proven successful on or before the September 21, 1995 survey. This assumption is not warranted by the facts or law. Therefore, I rejected HCFA's arguments that the assessment deficiencies found during the initial survey had caused actual harm (weight loss and erratic blood sugar readings) to this resident. HCFA Br., 76.
For the same reasons, I rejected also HCFA's conclusion that, for survey 1, Petitioner's failure to assess RESIDENT 4's low albumin problem "resulted in actual harm because the resident was malnourished." HCFA Br., 78.
As for the "actual harm" findings from the third survey also relied on by HCFA to impose the $300 per day rate, I have already made clear in my discussions for RESIDENT 1 of that survey that the "actual harm" findings are not supported. Again, HCFA had incorrectly assumed that any intervention which might have resulted from a proper assessment of these results would have proven successful by the time the surveyors made their observations.
Accordingly, I conclude that HCFA has shown only that Petitioner's assessment deficiencies of the first and third surveys have placed its residents at risk for more than minimal harm.
As for the prevalence of the assessment deficiencies from the third survey, I conclude that they were above "isolated" and occurring in at least a pattern.(60) Even though I had discussed only RESIDENT 1 for survey 3, I noted the recurrence of certain types of problems and Petitioner's repetition of excuses for like situations. Therefore, even the assessment deficiencies seen through the example of RESIDENT 1 suggested very strongly that they were not occurring in isolation. This conclusion is further supported when the assessment problems of the third survey are seen in the context of Petitioner's noncompliance with the inter-related care plan requirements of 42 C.F.R. § 483.20(d), as illustrated also by the example of the same resident. After two surveys had identified very similar assessment and care plan problems, the recurrence of like deficiencies once again during the third survey cannot be attributed to randomness. Moreover, the same types of assessment problems recurred in the fourth survey as well. Nothing presented by Petitioner negates this very strong implication that the same type of assessment deficiencies affecting RESIDENT 1 of Survey 3 were occurring in at least a pattern, affecting more than merely a few residents, during the third survey. For these reasons, there was at least a "pattern" of assessment deficiencies for the period covered by the third survey.
Given the degrees of prevalence and potential harm for the assessment deficiencies of the first and third surveys, I find that a CMP of $300 per day would be reasonable. In reaching this amount, I have considered the higher CMP rates which were upheld or imposed on administrative reviews of deficiencies which did not cause actual harm. See, e.g., Cross Creek Health Care Center, DAB No. 1665 (1998); Lake City Extended Care Center, DAB No. 1658 at 24 - 26 (1998). In comparison to those other CMPs collectable by HCFA, the $300 per day rate is on the low side. However, I do not raise the amount above the rate sought by HCFA because, in deciding what evidence to introduce for demonstrating the unreasonableness of the CMP amount in controversy, Petitioner may have used the $300 per day rate as a gauge. My raising the CMP rate above $300 per day at this juncture may be unfair to Petitioner.
FFCL 18: In considering Petitioner's financial condition, the issue is whether payment of an additional $250 per day for the 59 days covered by Surveys 1 and 3 would put Petitioner out of business.
As to the facility's financial condition, the proper inquiry is whether the amount of the CMP would put the facility out of business. This is the only conclusion suggested in the Federal Register. 59 Fed. Reg. 56204. Applying this standard also appears to be reasonable, given that the purpose for imposing any remedy is to prompt a facility to bring itself back into compliance and to remain in compliance. See 42 C.F.R. § 488.402. Therefore, no CMP amount should be set so low that it may be easily paid by a facility that has been out of compliance with program requirements. Payment of the assessed CMP amount may properly result in some financial hardship for the facility, without putting it out of business. Otherwise, there may be inadequate incentive for a facility to come into compliance and remain in compliance.
Under the facts of this case, Petitioner is already legally obligated to pay at least $50 per day for the periods covered by the first and third surveys. Accordingly, I am considering only
the issue of whether paying an extra $250 per day for those 59 days (or the sum of $14,750) would put the facility out of business.
FFCL 19: Under the "financial condition" factor listed in 42 C.F.R. § 488.438(f)(2), a CMP of $300 per day for the 59 days covered by Surveys 1 and 3 remains reasonable.
The record contains the testimony of Petitioner's former Chief Executive Officer, Thomas W. Hicks. The evidence establishes that Petitioner owns also the acute care hospital which adjoins the long-term care facility which was found to be out of compliance during the surveys discussed herein. Called by Petitioner as a witness, Mr. Hicks explained that the hospital's financial statements were consolidated with those of the long-term care facility's. Tr. 1571. Therefore, Mr. Hicks confirmed that the financial report filed with HCFA's Medicare Intermediary showed a gross revenue of about $1,600,000 for 1995 and the long-term care facility showed a profit for 1995. Tr. 1566, 1571 - 72. However, he could not recall what percentage of the profit was attributable to the long-term care side. Id. Moreover, according to Mr. Hicks, both the hospital and the long-term care facility jointly lost about $200,000 between January and February 1996. Tr. 1566, 1574. During later months, there were additional losses and some lay-offs of personnel. Tr. 1574. However, Mr. Hicks did not specifically attribute the additional losses or lay-offs to the long-term care facility.
With my authorization (Tr. 1579, 1615), Petitioner also provided additional financial information by letter dated January 14, 1997. In this letter, Petitioner shows the expenditure of $44,794.58 in "Direct Costs" for matters such as consultant's fees, fees paid for staff to attend seminars, and salaries paid for staff to testify at the hearing, which Petitioner represents to have been caused directly by the four surveys. Additionally, there were legal costs of $53,795.24 through December 31, 1996. There were also operational losses shown for both the hospital and the long-term care facility, totalling in the hundreds of thousands of dollars for 1996.
Mr. Hicks indicated that the hospital side was not "pulling the full weight, and the long term care unit couldn't pull it all by itself," and, were the long-term care facility to stand by itself without an adjoining hospital, the long-care facility would not be able to survive either. Tr. 1573. With respect to the $1,600,000 in profits for 1995, he noted that the amount could have been subject to adjustments by the Medicare Intermediary. Tr. 1573. He acknowledged that some portion of the profits could have been used to pay the CMP. Tr. 1572. However, because Petitioner is a "501C3" corporation, it was obligated to reinvest its profits back into the facility. Tr. 1575. Petitioner had no substantial amount of money in the bank. Tr. 1576. There was only a cash reserve of "a couple of thousand" on hand at a time, which would have enabled Petitioner to continue operating for nine days. Id.
On the basis of the evidence of record concerning Petitioner's financial condition, I cannot conclude that Petitioner would be put out of business by paying an additional $14,750 in CMP as a result of HCFA's decision to impose $300 per day for 59 days, instead of the minimum $50 per day. The evidence shows that, as a total entity, both the long-term care facility and the hospital have been experiencing financial difficulties before and since the four surveys under review. As of the end of 1996, its legal costs and efforts to remedy its noncompliance had already totalled nearly $100,000. Yet notwithstanding these expenditures and reported losses for 1996, Petitioner has continued to operate. Therefore, there is an inadequate basis for concluding that Petitioner would be unable to remain in business if required to pay an additional $14,750 in CMP.
FFCL 20: Accordingly, having considered the evidence of record relevant to the regulatory criteria, I conclude that Petitioner should pay a CMP at the rate of $300 per day for the 59 days covered by the first and third surveys (from November 16 through December 19, 1995 and from February 23 through March 18, 1996).
FFCL 21: HCFA had a basis for imposing also the denial of payment for new admissions (DPNA) remedy from March 13, 1996 through March 20, 1996.
Petitioner does not specifically ask to be relieved of the DPNA remedy. However, HCFA's notice letter makes clear that it was imposed, effective on March 13, 1996. HCFA Ex. 10. HCFA asks for affirmance of this remedy. HCFA Br., 125.
HCFA's notice letter of February 26, 1996 indicates that the DPNA remedy was being imposed as a result of the noncompliance found during the September 1995 survey. In using March 13, 1996 as the effective date of this remedy, the notice letter refers to a three-month period of noncompliance. HCFA Ex. 10 at 2. Under the regulations, HCFA must deny payments for new admissions "3 months after the lst day of the survey identifying the noncompliance . . . ." 42 C.F.R. § 488.417(b)(1). More than three months have elapsed since the first day of the September 1995 survey, which found noncompliance.
However, the regulations also require HCFA to give 15 days of notice to a facility in advance of effectuating the DPNA remedy. 42 C.F.R. § 488.402(f)(4). Therefore, in its notice letter dated February 26, 1996, HCFA set the effective date of the DPNA at March 13, 1996. But for HCFA's delay in issuing the DPNA notice, HCFA could have begun this remedy three months after the first day of the September 1995 survey, as suggested by its letter. See 42 C.F.R. § 488.417(b)(1).
For the foregoing reasons, I affirm HCFA's imposition of the DPNA remedy for the identified period.
I have affirmed HCFA's basis for imposing a CMP against Petitioner for the period from November 16, 1995 through March 20, 1996. Therefore, as a matter of law, HCFA has a right to collect at least $50 for each day of that period. Even though I did not find reasonable HCFA's calculation of an additional $250 per day for 59 the days from November 16 through December 19, 1995 and from February 23 through March 18, 1996, I am authorizing HCFA's collection of that additional amount for each of those 59 days on alternative grounds.
Additionally, to the extent there was any dispute concerning the DPNA remedy HCFA had imposed also against Petitioner, I uphold the validity of that remedy for the period from March 13, 1996 until March 20, 1996, when Petitioner attained compliance with program requirements.
Mimi Hwang Leahy
Administrative Law Judge
1. The supplemental hearing was held because, prior to the
initial hearing in this case, I had allocated the burden of
persuasion to HCFA.
During February 1997, an appellate panel of the Departmental
Appeals Board (DAB) issued Hillman Rehabilitation Center, DAB No.
1611 (1997), which allocated the burden of persuasion to the
health care provider. Therefore, I allowed the parties to
comment on the applicability of Hillman to this case and to
inform me whether any additional proceedings were warranted.
Between April and June 1997, the parties filed briefs and
counter-briefs on these issues.
In a ruling dated July 22, 1997 ("Ruling on Burden of Persuasion
Issue and Related Matters Raised by Petitioner"), I held that
HCFA has the burden of persuasion in this case and that
Petitioner may supplement the record by making the showing and
following the procedures I had specified. In response,
Petitioner offered 65 proposed exhibits, a list of 5 witnesses,
along with other filings during August 1997. In late September
1997, HCFA submitted 9 pages of objections, plus an appendix.
In November 1997, I ruled on HCFA's objections during a
conference with the parties, and I scheduled the supplemental
hearing for January 14, 1998. Confirmation of Prehearing
Conference with the Parties (Nov. 26, 1997).
2. Because HCFA's counsel refused to fully withdraw his
numerous objections of irrelevancy (all of which proved to be
meritless), Petitioner was forced to offer its exhibits in
separate blocks on separate days, and to receive separate rulings
from me on each document's admissibility. Tr. 37 - 40.
3. Each party, by its counsel, has taken undue liberties
with adding documents to the record by attaching them to their
posthearing briefs. They adopted this approach after I had
indicated at the conclusion of the initial and supplemental
hearings that the parties may not submit additional testimonial
or documentary evidence without my permission. I am not striking
any of these appended documents only because I wish to avoid
increasing the proceedings.
4. In this decision, "noncompliance" means a failure to be
in substantial compliance, as defined in 42 C.F.R. § 488.302.
5. The 1996 version of 42 C.F.R. is used because that is
when the hearing request was filed. There has been no
substantive changes in the regulations between 1995 when some of
the surveys took place, and 1996, when the hearing request was
filed.
6. The surveyed residents were assigned sequential numbers
by the surveyors. The surveyor always began with "Resident 1" in
each survey. Therefore, Resident 1 from the first survey may not
be the same resident as the individual with the same designation
in subsequent surveys. Similarly, the same resident may have
different numerical identifiers in different surveys. Unless my
discussions indicate otherwise, it should be assumed that
different residents were reviewed during each survey.
7. Petitioner objects to HCFA's use of these interpretive
guidelines because they were never promulgated as rules or
regulations. However, Petitioner cites them readily when they
support its position.
8. This regulation concerns the effectuation of what is
contained in comprehensive assessments and comprehensive care
plans. It entitles each resident to receive (and obligates the
facility to provide) "the necessary care and services to attain
or maintain the highest practicable physical, mental, and
psychosocial well-being, in accordance with the comprehensive
assessment and plan of care." 42 C.F.R. § 483.25.
9. Petitioner contended that Tag F-272 "refers to the
completion of the Minimum Data Set (hereinafter 'MDS') . . ."
and--
[t]he Code of Federal Regulations does not
indicate that the facility is responsible for
completing requirements that are above and
beyond the uniform data set as specified by the
regulation. The performance of RAPS is done
. . . in any format which the facility wishes to have it
accomplished. There is no uniform set of forms to be
used in the completion of the RAPS.
P. Br., 7 - 8.
10. As shown by the testimony of its witnesses and by the
analysis contained in its posthearing briefs, HCFA had evaluated
information appearing in other documents as well.
11. HCFA disagrees with Petitioner's assertions concerning
the staff's low turnover rate. HCFA Reply, 12.
12. The 11 residents were identified as Residents 1 through
11.
13. Such "Tags" are used by surveyors in their written
reports to identify particular categories of deficiencies they
find at a facility. Each "Tag" has correlation to requirements
specified in the federal regulations.
All of the surveyors who appeared as witnesses at the hearing in
this case referred to such "Tags" in their testimony.
14. The surveyors associated the assessment deficiencies
with this resident's "negative outcome with low blood sugars and
erratic blood glucose readings." HCFA Ex. 3 at 15. I do not
find adequate evidentiary support for this conclusion. The
assessment the surveyors reviewed was dated September 19, 1995
and the surveyors commenced their inquiries on September 21,
1995. Even if this resident's condition had been assessed
properly and comprehensively by Petitioner, the next step would
have been for the planning of appropriate intervention in a
written care plan under 42 C.F.R. § 483.20(d). The regulations
do not require that any intervention be proven successful upon
initiation. Therefore, I am unable to conclude, as the surveyors
had, that the "negative outcome" they observed on September 21,
1995 resulted from Petitioner's failure on September 19, 1995 to
comply with the comprehensive assessment regulation.
15. According to the evidence submitted by Petitioner,
Petitioner is using the term "advance directive" rather loosely.
However, for the sake of convenience, I will not use a different
term in evaluating Petitioner's evidence.
16. Petitioner's nursing records for September 1994 show
that RESIDENT 1 has more than one son. P. Ex. 7. The "Durable
Power of Attorney" Petitioner introduced does not show which of
her sons was given the power of attorney. P. Ex. 11.
17. On the March 31, 1993 form, Petitioner had written in
"Resident 1" on the line requiring the signature of the patient,
relative, or guardian.
18. This is the very last entry on the RAP summary sheets of
record.
19. I will not repeat here my previously stated criticism of
the cavalier manner in which Petitioner appears to embrace family
preferences in order to justify its inadequate written
assessments.
20. I accept Dr. London's opinion that this resident was not
malnourished. Even though the surveyor had given a contrary
opinion, I find that Dr. London's opinion is of more weight given
his professional training and experience.
21. This document is titled "Admission History & Physical."
Inasmuch as Dr. Metwally included the resident's "Admitting
Diagnosis," "Admission medications," "Past Medical History," and
concluded by stating "[t]he patient was admitted to the SNF Unit
with the above mentioned plan for continued care," it appears
that this document signed by Dr. Metwally on December 7, 1995
relates to the requirement of 42 C.F.R. § 483.20(a). This
subsection of the regulation requires that--
[a]t the time each resident is admitted, the
facility must have physician orders for the
resident's immediate care.
42 C.F.R. § 483.20(a).
22. A discharge summary is required by 42 C.F.R. §
483.20(e).
23. I assume this document of record reflects Petitioner's
efforts to prepare a comprehensive plan of care in accordance
with the requirements of 42 C.F.R. § 483.20(d), as Petitioner
contends that this resident was treated appropriately in light of
her multiple medical problems after having been "assessed and
care planned." P. Br., 12 (citing Dr. Metwally's testimony).
24. Petitioner has referred only to page 7 of its Exhibit 45
as a RAPs done for this resident. P. Br., 13.
25. Petitioner contends that this resident needed to be
"slowed down" because some of his socialization activities were
viewed as inappropriate by staff.
26. The care plan does not indicate whether a tray table
should be in place whenever the resident is sitting in the geri-chair. However, it is apparent from Petitioner's arguments
quoted above that it concedes that the geri-chair, whether with
or without a tray table in place, constitutes a restraint.
27. For this resident, Petitioner argued also that its
small, knowledgeable, and stable staff could not have allowed
harm to come to this resident through the provision of unplanned
services and that a mere documentation error had occurred with
respect to Propolis. P. Reply, 11 - 12. I have already
addressed and rejected these lines of argument elsewhere in this
decision.
28. Petitioner alleges that the resident was "admitted to
the SNF unit for acute rehabilitation of her compromised
condition as it related to the congestive heart failure." P.
Br., 21 - 22. However, Dr. Metwally stated in his notes that,
prior to this resident's admission to Petitioner's skilled
nursing unit, this resident had already received "intensive rehab
therapy" while she was hospitalized and placed on the "Rehab
Floor" of Petitioner's hospital for "some time." Id.
29. Petitioner notes that Haideh Najafi, the surveyor who
initially identified the problems with RESIDENT 2's assessments,
was in training as a surveyor. P. Br., 48. However, she was
also a Registered Nurse. HCFA Ex. 6 at 1. Therefore, I find
that she was qualified to review those nursing notes and related
records maintained by Petitioner in order to provide her opinions
on this resident's prior use of medications, medical history, and
the likely cause of those symptoms experienced by the resident.
30. HCFA cited also the surveyor's testimony that there was
shaking of this resident's head and body. HCFA Br., 25. I note,
however, that Petitioner had asked for a stipulation that the
relevant notes taken by the surveyor indicated shaking only in
the upper body but HCFA refused to provide it. Tr. 434. Since
the problem before me concerns the failure to assess symptoms
which are at least seizure-like, I do not find it worthwhile to
explore any alleged clinical significance between the shaking of
the resident's entire body as opposed to her upper body.
31. The MDS form completed by Petitioner on December 4, 1995
shows that it was done as an "annual assessment" and not for any
significant change in status. P. Ex. 29, at 1, 2.
32. Whether or not a seizure disorder was identified on the
MDS form is not dispositive of whether an appropriate or complete
assessment had been done by Petitioner. As I discuss below,
Petitioner argues that seizure disorder, seizures, and seizure-like symptoms do not trigger RAPs. Therefore, Petitioner does
not deny that the seizure-like symptoms were never evaluated
pursuant to the RAPs process.
Moreover, based on the arguments and evidence of record before
me, I find more credible the surveyor's testimony that there was
no check mark next to the "Seizure disorder" box of the MDS form
she reviewed on December 20, 1995 at Petitioner's facility. She
has no incentive to testify untruthfully and she explained how
she had proceeded to consider other documents because the MDS
form contained nothing on point. As I will discuss later in this
decision, Petitioner's arguments indicate that its staff did not
believe that the resident had an active seizure disorder when the
MDS form was completed on December 4, 1995. Therefore, it seems
peculiar that a check mark should have been placed next to the
box for "Seizure disorder" on December 4, 1995, when the
instructions state "[d]o not list inactive diagnoses." P. Ex.
29, at 5.
33. The facility's assessments must be coordinated and
certified by a registered nurse. 42 C.F.R. § 483.20(c)(2). The
resident's attending physician must be involved only when a plan
of care is being prepared on the basis of the completed
assessments. 42 C.F.R. § 483.20(d)(2)(ii).
Additionally, the preamble to the regulations are clear that "[a]
facility cannot excuse itself from [its] obligation by deferring
responsibility to an individual (the physician) with whom neither
the State nor the Secretary has any statutory relationship for
the purpose of maintaining compliance with facility health and
safety standards." 59 Fed. Reg. 56,227 (1994).
34. Petitioner specified that this resident was covered by
only Medicaid and Medicare, Part B, insurance. P. Ex. 29 at 3.
The latter is an insurance which may be voluntarily purchased by
any individual. Section 1832(a) of the Act. As relevant to the
contacts Petitioner had with a physician concerning this
resident's seizure-like activities, I note that Medicare, Part B,
provides payments for, among other things, services rendered by
participating physicians to the insured. Id.
35. Petitioner noted that the readmission occurred on
January 30, 1996. P. Reply, 40 at n.1. The third survey
occurred during February 21 through 23, 1996.
36. I do not decide whether the Bucks traction had been
applied correctly, or whether Petitioner's staff knew how to
apply it correctly at the time of the February 1996 survey.
These matters do not have material bearing on Petitioner's
failure to make the assessments discussed herein. I have noted
the surveyor's opinions on these matters only in so far as they
explain why she decided to investigate the existence of relevant
assessments.
37. Other evidence identified by HCFA indicates that this
resident continued to lose weight after her readmission on
January 30, 1996. HCFA Br., 38. However, there is only a small
amount of information concerning the rate and amount of her
weight loss between January 30 and late February when the third
survey took place. The reason is that Petitioner's staff did not
make provisions for weighing this resident more than once each
month. Petitioner contends that the schedule does not reflect
indifference to her weight loss. It states that the resident was
weighed only once a month because she was recovering from her hip
replacement procedure, and use of the facility's Hoyer bed scale
to weigh her would have placed stress on her surgery site. P.
Reply, 41.
38. See, for example, my earlier discussion of Resident 1 of
the first (September 1995) survey. Petitioner had also failed to
indicate in the MDS form for this resident that she had suffered
significant weight loss.
39. Petitioner has made various arguments under the apparent
belief that HCFA is alleging actual harm to RESIDENT 1 based also
on the assessment problems. I am not certain that HCFA has taken
that position in its posthearing briefs, even though HCFA did
note that this resident continued to lose weight after she was
improperly assessed on her readmission. However, if HCFA is
asking me to conclude that actual harm had resulted to this
resident from the assessment process, I would reject that
conclusion for the same reason as stated previously. There is
not adequate evidence to support the conclusion that, even if
RESIDENT 1 had been assessed correctly on her readmission date of
January 30, 1996, any intervention provided in a resulting care
plan would have proven successful in reversing or controlling her
weight loss by the time the survey took place during the end of
February 1996.
40. As support of these time periods, Petitioner cites a
surveyor's testimony on cross-examination. Tr. 455. However,
the surveyor did not provide incorrect testimony to suggest that
"a facility has 14 days to complete a comprehensive assessment of
the resident and 21 days following that date to complete the care
plan for the resident" (P. Br., 51). She properly answered "yes"
to the question, "[i]sn't it true that a facility has seven
additional days in which to complete a comprehensive care plan?"
Tr. 455.
41. As shown by the testimony cited by HCFA, the surveyor
was aware that this resident was a long-term diabetic. However,
HCFA does not dispute Petitioner's assertions that this resident
had also suffered from a cerebral vascular accident (CVA), which
prompted her admission to Petitioner's facility. See P. Br., 72.
Nor does HCFA dispute that this resident was experiencing pain in
her upper left extremity as a result of her CVA, and, therefore,
she was receiving treatment for her pain from a pain clinic. Id.
42. Malleolus is "a rounded process, such as the
protuberance on either side of the ankle joint." Dorland's
Illustrated Medical Dictionary 975 (27th ed. 1988).
43. As HCFA has pointed out, the surveyor identified
possible causes for the signs and symptoms exhibited by this
resident based on her reading of some medical literature
concerning the medication Gabapentin. See HCFA Br., 50. Based
on her reading of this article, the surveyor reached the
conclusion that this resident was given dosages of Gabapentin
which were above the level recommended by this article. Id. She
also criticized Petitioner for failing to consider the potential
side effects of Gabapentin, which were noted in the publication.
Id.
Ordinarily, I would have disregarded such testimony because the
information contained in the publication has not been established
to be reliable by qualified experts or by judicial notice.
However, the publication the surveyor read was provided to her by
Petitioner. Tr. 816. Petitioner provided it to her because she
told Petitioner she did not know anything about Gabapentin. Tr.
815 - 16, 840. Therefore, Petitioner cannot repudiate the
accuracy of the information contained in that publication.
44. The surveyor is a Registered Nurse and holds a Masters
degree in Nursing. Tr. 808. She described a Stage II pressure
sore as one in which only the outer layer of skin is gone; by
contrast, in a Stage III pressure sore, both layers of skin are
gone and the wound is down to the subcutaneous tissue. Tr. 818.
45. According to Petitioner, a vascular surgeon recommended
amputation but refused to perform the procedure. P. Reply, 52.
Petitioner points to Dr. Metwally's testimony concerning the
development and progression of gangrene in people with severe
vascular impairments. Id. Dr. Metwally stated that when someone
without circulation develops gangrene, there usually follows a
worsening of the gangrene, infection, and then amputation. Tr.
1375. Also according to Dr. Metwally, the surgeon declined to
operate on RESIDENT 7 because she was bedridden, suffered from
paralysis, and was "not a good candidate for surgery." Id. I
take the last opinion to mean that this resident was considered
likely to die or develop life-threatening complications if a
physician were to amputate her left leg.
46. Since Gabapentin is alleged to have caused improvements
in the resident's circulation sometime after the March 1996
survey, I note that the dosage level of that medicine was
adjusted due to the questions raised by a surveyor.
As pointed out by Petitioner's brief, neither its staff nor Dr.
Metwally was familiar with Gabapentin. They were not familiar
with this medication because it was "on the cutting edge of pain
management" and its usage had been recommended by another
physician working at a pain clinic. P. Br., 72; HCFA Br., 52
(citing Tr. 1371). Petitioner acknowledges also that, when the
surveyor asked for information about this medication upon finding
no assessment for its use, Petitioner had to obtain information
about it by telefax from the pain clinic. See P. Br., 72.
The surveyor testified that the daily dosage level of the
Gabapentin was lowered on the very day she raised questions about
it to Petitioner during the survey. Tr. 841. Petitioner does
not specifically deny the truth of her statements, nor does it
claim to have made any dosage determination. Moreover, Dr.
Metwally denies having personally reduced the dosage level after
the surveyor identified this issue. Tr. 1376. His testimony is
unclear but suggests that the decision to reduce the dosage may
have been made by the pain clinic physician. Tr. 1376 - 77.
Petitioner supports this reading of this testimony by claiming
that improvement was attained by the resident "by complying with
the physician's orders at the pain clinic, through the use of
Gabapentin . . . ." P. Br., 72. Therefore, Petitioner cannot
even claim that the dosage reduction decision was made by Dr.
Metwally, an employee of the hospital which owns the nursing care
facility. See Tr. 1319.
47. December 19, 1995 was the date immediately preceding the
second survey. When a facility is found out of compliance during
a survey, the noncompliance is deemed to last until there is a
satisfactory showing that substantial compliance has been
attained. See 42 C.F.R. § 488.440(h).
The beginning date for the CMP remedy was set at November 16,
1995 (and not when deficiencies were first found during the
September 1995 survey) because the State surveying agency had not
completed its reevaluation of those survey findings until
November 16, 1995. HCFA Ex. 2.
48. Petitioner was deemed to be in substantial compliance
with all participation requirements after this date.
49. A CMP is an alternative remedy listed in 42 C.F.R. §
488.406, which may be selected for imposition by HCFA under 42
C.F.R. § 488.408.
50. Q [by HCFA counsel]: So you felt $300 was, you know--
A [by Ms. Debro]: We thought--
Q: -- appropriate because the G--well, what was
the highest--
A: The highest--
Q: -- level on the grid that you found
violations in this case?
A: -- G, I believe. I don't remember, but I
believe it was the G.
51. During the hearing, the relevant questions and answers
were as follows:
JUDGE LEAHY: [A]t the time that you drafted
this notice letter dated February 26, you were
aware that the State of Michigan was not
recommending a CMP for this facility?
THE WITNESS: No, I was not.
JUDGE LEAHY: You were not aware?
THE WITNESS: No, . . . I didn't. [I]t was
boilerplate kind of language on our letters,
form letters.
. . . .
Well, we have form letters.
. . . .
And we plug in the information, and that was
one of the paragraphs that we included the
state's recommendation, and it should not have
been in there.
. . . .
JUDGE LEAHY: In hindsight . . . what would you
have done had you been aware that the state was
not recommending a CMP?
THE WITNESS: I would have personally done a
profile of the facility, and then I would have
called the state to ask them what their
guidelines in doing a profile of the facility
would have been, and then I would have--I guess
I would have been told that Michigan does not
do that.
Tr. 581 - 82.
52. At the time Ms. Debro was preparing HCFA's letter, there
was a State agency recommendation to impose a CMP of $300 per day
for Survey 1, if noncompliance continued until December 16, 1995.
HCFA Ex. 2. After HCFA issued its CMP notice letter to
Petitioner, HCFA received the State agency's recommendation dated
March 22, 1996 to impose a $300 per day CMP also for Survey 3.
HCFA Ex. 19.
53. I note, as an example, Ms. Debro's testimony, which
incorrectly posits that a CMP of $50 per day cannot be imposed
unless there existed actual harm to residents:
Well, after looking at the 2567 and the review
of the plan of correction, and based on my
experience and understanding, I felt that it
would warrant the civil money penalty because,
if we were--the idea is not to get a level that
would cause actual harm to a resident, and the
lowest CMP then would fall under the $50 a day.
So the G would--I figured it would be $300.
Tr. 559.
54. HCFA provided a copy of the Federal Register page. HCFA
Ex. 23 at 1. Then HCFA provided also a printed page (with no
origin on its face) showing that someone had handwritten in "D"
through "L" on a copy of the chart that was published in the
Federal Register to explain the three categories of remedies.
Id. at 2.
55. Ms. Bacon stated in her declaration, for example:
[i]n the March 22, 1996 letter and memorandum,
I recommended that HCFA impose a civil money
penalty beginning February 23, 1996 because a
revisit survey of Kelsey on that date found the
highest level violation of the participation
requirements to be a "G."
HCFA Ex. 21 at 3 (emphasis added).
56. In the other case, HCFA asserted in its brief that a
scope and severity grid contained in Michigan Bulletin 95-03 is
identical to the grid which was published in the Federal Register
(59 Fed. Reg. 56,183) by the Secretary of Health and Human
Services. However, the grid contained in Attachment One of
Michigan Bulletin 95-03 has no counterpart in the Federal
Register.
57. I noted by footnote in the other case that for
"Historically Compliant" facilities, the fixed daily rates begin
at $300. In this case, HCFA states that the CMP of $300 per day
was recommended and set because Petitioner was not considered to
have had a history of noncompliance. HCFA Br., 117.
58. A CMP must be set at $50 increments. 42 C.F.R. §
488.438(a).
59. In making this finding, I am rejecting the surveyors'
determination that the deficiencies were "isolated," as indicated
by their use of the "G" Scope and Severity level. See, HCFA Ex.
23 at 3.
60. In making this finding, I am rejecting the surveyors'
conclusion that the deficiencies were "isolated," as reflected in
their use of the "G" Scope and Severity level. See HCFA Ex. 23
at 3.