CASE | DECISION | JUDGE | FOOTNOTES

Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Civil Remedies Division
IN THE CASE OF  


SUBJECT:

Lakeland Continuing Care Center,

Petitioner,

DATE: July 18, 2000
                                          
             - v -

 

Health Care Financing Administration

 

Docket No.C-97-070
Decision No. CR683
DECISION
...TO TOP

Below, I affirm the conclusion of the Health Care Financing Administration (HCFA) that Petitioner was out of substantial compliance with Medicare and Medicaid participation requirements during the surveys conducted in August 1996 and October 1996. Therefore, I uphold also HCFA's decision to impose a Civil Money Penalty (CMP) against Petitioner for the corresponding 92 days of noncompliance. Upon considering the reasonableness of the CMP rates assessed by HCFA ($1,500 for each of the first 70 days and $1,000 for each of the remaining days), I find the rate of $1,000 to be reasonable for each of the 92 days.

I. Ruling on Petitioner's Motion for Specific Findings of Fact and Conclusions of Law for Tag F314 cited in the August 1996 Annual Survey and Tag F324 cited in the October 1996 Revisit Survey.

With its Post-Hearing Brief (Pet. Br.), Petitioner filed a motion(1) requesting that I issue specific findings and legal conclusions concerning its dispute with the scope and severity levels which were assigned by HCFA to particular citations of noncompliance. Petitioner seeks to have me review and lower the "H" and "G" scope and severity levels that appear in the record with the noncompliance citations reported as, respectively, Tag F314 (corresponding to certain findings of noncompliance under 42 C.F.R. § 483.25(c)) in the annual survey of August 1996 (2), and as Tag F324 (corresponding to certain findings of noncompliance under 42 C.F.R. § 483.25(h)(2)) in the revisit survey of October 1996.(3)

Petitioner filed this motion because in Kelsey Memorial Hospital v. HCFA, DAB CR583 (1999), I had explained why I did not find it necessary to resolve in a written decision every matter on which the parties had expressed disagreement. During the hearing in the present case, I declined to make a commitment to Petitioner that I would address in my decision the merits of each citation and each scope and severity level contained in each survey report contested by Petitioner. As I explained in the Kelsey Memorial Hospital decision and to the parties now before me, I review the total record in each case as the parties have created it before I draft my decision. However, given the nature of litigation, parties often present me with more information than what is needed to decide the dispositive issues in CMP cases: namely, whether HCFA had a factual basis for imposing the enforcement remedy at all; and, if so, whether the CMP rate chosen by HCFA is reasonable.

Petitioner argues in its motion that I should issue specific rulings on Tag F314 from the August 1996 survey and Tag F324 from the October 1996 resurvey because they have been assigned scope and severity levels of "H" and "G," respectively, and those "H" and "G" designations affected the selection of the type of remedy (in this case, a CMP), as well as "the range of the civil money penalties that could be imposed." Pet. Motion, at 2 (emphasis added); Pet. Br., at 89-90. As best as I can understand from Petitioner's Post-Hearing Brief, its "cause-effect" argument relies, in turn, upon its other arguments that:

-- the regulation at 42 C.F.R. § 498.3(b)(13) allows a facility to challenge the level of noncompliance if a successful challenge "would affect the range of civil money penalty amounts that HCFA could collect," and, according to Petitioner, "[c]ertainly, the 'H' and 'G' citations in question affect the range;"

-- if HCFA successfully proves for the August 1996 standard survey and the October 1996 revisit survey that Petitioner's failings under Tag F314 and Tag F324 were at the "H" and "G" levels of noncompliance, respectively, then Petitioner will become at risk for incurring the additional adverse consequences provided by 42 C.F.R. § 488.414, which apply if substandard quality of care findings have been made during "the last three consecutive standard surveys, as defined in 42 C.F.R. § 488.305 . . . ;"

-- if HCFA successfully proves for the August 1996 standard survey and the October 1996 revisit survey that Petitioner's failings under Tag F314 and Tag F324 were at the "H" and "G" levels of noncompliance, respectively, then pursuant to 42 C.F.R. § 488.438(d), the CMP in controversy may be elevated to the upper monetary range ($3,050 to $10,000 per day) provided therein;

-- one of HCFA's witnesses at the hearing, Ms. Pauline Swalina, testified that it was possible that the Michigan Department of Consumer and Industry Services (Michigan State survey agency) would have forwarded no recommendation for the imposition of any CMP, if the Michigan State survey agency had not made the "H" Level determination against Petitioner; and,

-- in concluding that "HCFA failed to establish a basis for the upper-level CMP imposed" against a different facility, Administrative Law Judge Steven Kessel had issued a decision which "separately and specifically addressed the tags" that were not successfully proven by HCFA to support the "upper-range civil money penalty" set aside by Judge Kessel.

Pet. Br., at 89-90.

I find most of Petitioner's arguments inapposite, and the remainder of them legally untenable. In the Kelsey Memorial Hospital decision, DAB CR583 (1999), I have addressed the equivalent of the legal issues raised by Petitioner herein. In Kelsey Memorial Hospital, both parties had attached improper significance to the scope and severity Level designations. I provided detailed analyses of my legal conclusions. Here, I reiterate that I lack the authority to review either the recommendations forwarded to HCFA by State agency surveyors or HCFA's exercise of its discretion in selecting the type of enforcement remedies to impose(4), and therefore, I cannot change the scope and severity level designations that have already been assigned or used for those purposes. I explained also how the evaluation of whether a CMP rate set by HCFA is reasonable must be done with use of the "seriousness of deficiencies" factor listed in 42 C.F.R. §488.404(b) instead of the scope and severity level designations that were specifically rejected in the promulgation of the final regulations applicable to nursing home enforcement cases. Kelsey Memorial Hospital, DAB CR583 (1999), at 69, et seq.

Additionally, Petitioner's use of regulatory citations and Judge Kessel's decision concerning "upper-range" CMP amount are inappropriate to the facts of this case. The CMP rates at issue in this case are $1,500 per day for the period covered by the first survey (August 9, 1996 through October 17, 1996), and the rate of $1,000 per day for the period covered by the resurvey (October 18, 1996 to November 7, 1996). Both rates were drawn from the lower penalty range specified by 42 C.F.R. § 488.438.

The regulation does state that a facility may challenge the "level of noncompliance found by HCFA . . . only if a successful challenge on this issue would affect the range of the civil money penalty amounts that HCFA could collect." 42 C.F.R. § 498.3(b)(13)(emphasis added). However, this regulation has no applicability to the facts of this case. Petitioner has confused the "level of noncompliance" relevant to the upper or lower ranges of a CMP ($50 to $3,000 per day, versus $3,050 to $10,000 per day) with scope and severity level designations such as "H" and "G." In the published regulations, appealable levels of noncompliance relevant to the CMP ranges mean only whether the noncompliance had occurred at the immediate jeopardy level or at the non-immediate jeopardy level. 42 C.F.R. § 488.438(a); see also, 59 Fed. Reg. 56,179 (1994)(5). By contrast, the "H," "G," and other letter designations in the scope and severity scales were expressly deleted from the final regulations(6), and these designations are not alleged by Petitioner to correspond to any immediate jeopardy determination. For these reasons, nothing presented by Petitioner posits a credible suggestion that Petitioner's liability for the CMP will be increased to the upper range of $3,050 to $10,000 per day unless I specifically set aside the "H" and "G" designations for the two F Tags.

Finally, there is no logical connection between the "H" and "G" designations of record to the risk alleged by Petitioner for having HCFA impose additional sanctions pursuant to 42 C.F.R. § 488.414. The "H" designation arose from a standard survey, while the "G" designation arose from a follow-up or revisit survey. For the consequences specified by 42 C.F.R. § 488.414 to apply, that regulation states clearly that there must be substandard quality of care findings made during "the last three consecutive standard surveys, as defined in 42 C.F.R. § 488.305 . . . ." 42 C.F.R. § 488.414(a)(emphasis added). In this case, I did not have the merits of three consecutive standard surveys for review.(7)

Accordingly, I deny the specific relief requested by Petitioner's motion. I will issue findings and conclusions to the extent necessary to resolve the central issues of whether Petitioner was out of substantial compliance with one or more program requirements, and, if so, whether the CMP amount HCFA sought is reasonable. I will also analyze the evidence appropriate to determining the "seriousness of deficiencies" in accordance with the standards specified in 42 C.F.R. § 488.404(b), as incorporated by 42 C.F.R. § 404.438(f)(3).

II. Overview of Disputed Survey Findings to be Addressed in Decision.

According to HCFA, when the standard annual survey was conducted from August 6-9, 1996, the majority of Petitioner's noncompliance problems fell into the following categories(8):

A. Comprehensive assessments -- that is, failure to conduct comprehensive, accurate, and timely assessments of requisite frequency for each resident in accordance with 42 C.F.R. § 483.20(b) and 42 C.F.R. § 483.20(b)(4) (Tag F272 and Tag F273).

B. Comprehensive care plans -- that is, failure to develop comprehensive and timely care plans for each resident in accordance with 42 C.F.R. § 483.20(d) (Tag F279).

C. Quality of care -- that is, delivery of substandard quality of care to residents, as shown by:

1. failure to prevent the development of avoidable pressure sores or failing to provide necessary treatment and services to promote healing of pressure sores, as required by 42 C.F.R. § 483.25(c)(Tag F314);

2. failure to provide necessary grooming and personal and oral hygiene to residents who are unable to independently carry out activities of daily living, as required by 42 C.F.R. § 483.25(a)(3)(Tag F312);

3. failure to provide appropriate services to increase, or prevent decrease of, residents' range of motion, as required by 42 C.F.R. § 483.25(e)(2)(Tag F318); and

4. the use of an indwelling catheter, in contravention of 42 C.F.R. § 483.25(d)(1)(Tag F315).

D. Nursing services -- that is, failure to provide adequate staffing, as required by the nursing services regulation at 42 C.F.R. § 483.30(a)(1) and (2)(Tag F353).

For the August 1996 survey findings, HCFA posited that the substandard quality of care residents received likely resulted from Petitioner's noncompliance with the comprehensive assessment and care plan requirements, as exacerbated by inadequate staffing. HCFA Br., at 12.

For the second or revisit survey of October, 1996, HCFA contended that "there was also concern . . . that deficiencies involving comprehensive resident assessments and care plans, exacerbated by inadequately trained nurse aides, were related to, and in at least some instances may actually have contributed to, the deficiencies involving quality of care." HCFA Br., at 66. These arguments are based on the October 1996 Michigan State agency resurvey team's findings that Petitioner continued to remain out of substantial compliance with: (a) the comprehensive resident assessment requirements of 42 C.F.R. § 483.20(b)(Tag F272); (b) the care plan requirements of 42 C.F.R. § 483.20(d)(Tag F279); and, (c) the quality of care requirements of 42 C.F.R. § 483.25, in so far as they entitle each resident to receive (1) appropriate services for the prevention and treatment of pressure sores (42 C.F.R. § 483.25(c))(Tag F314); (2) adequate supervision and assistive devices to prevent accidents (42 C.F.R. § 483.25(h)(2))(Tag F324); and (3) no unnecessary drugs (42 C.F.R. § 483.25(l)(1))(Tag F329).

In addition, HCFA found that Petitioner was out of substantial compliance with the portion of the "Administration" regulation which governs the amount and frequency of in-service training for nurse aides (42 C.F.R. § 483.75(e)(8))(Tag F497).

The evidence of record shows the methods by which HCFA made its findings of noncompliance against Petitioner. During each of the two surveys in controversy, the respective Michigan State agency survey teams selected a set number of residents as samples. The surveyors reviewed Petitioner's records for these sample residents. For some of these sample residents, the surveyors also made personal observations of their condition and of the services delivered to them by Petitioner's staff.

III. Summary of Relevant Program Participation Requirements and their Relatedness.

Key portions of the regulations governing quality of care, assessments and care plans, nursing services, and administration make their relationship obvious. In reflecting the central purpose for which any nursing home has been given certification to participate in the Medicare and Medicaid programs, all of these regulations direct the participating facility to be mindful of its resident's right to receive from it the necessary care and services "to attain or maintain the resident's highest practicable physical, mental, and psycho social well-being . . . ." 42 C.F.R. §§ 483.20(d)(1)(i)(emphasis added); 483.20(d)(1); 483.25; 483.30; 483.75.

To ensure that each resident receives the services to which he is entitled, the participating facility must timely conduct initially, at periodic intervals, and whenever appropriate, a written comprehensive, accurate, standardized, and reproducible assessment of each resident's functional capacity. 42 C.F.R. § 483.20, 483.20(b). The results of these assessments must be used by the facility to develop, review, and revise each resident's comprehensive plan of care. 42 C.F.R. § 483.20(b)(6). The comprehensive plan of care developed for each resident must include measurable objectives and timetables to meet the resident's " medical, nursing, and mental and psycho social needs that are identified in the comprehensive assessment." 42 C.F.R. § 483.20(d)(1). Moreover, the comprehensive plan of care must list those services that will be provided to enable each resident to attain or maintain his "highest practicable physical, mental, and psycho social well-being as required under 42 C.F.R. § 483.25 [the regulation titled "Quality of care"] . . ." 42 C.F.R. § 483.20(d)(1)(i)(language in brackets added).

The "Quality of care" regulation re-emphasizes that "[e]ach resident must receive[,] and the facility must provide [,] the necessary care and services to attain or maintain the highest practicable physical, mental, and psycho social well-being, in accordance with the comprehensive assessment and plan of care." 42 C.F.R. § 483.25 (emphasis added).

The regulation also contains the specific requirement that:

(c) Pressure sores. Based on the comprehensive assessment of a resident, the facility must ensure that-

(1) A resident who enters the facility without pressure sores does not develop pressure sores unless the individual's clinical condition demonstrates that they were unavoidable; an

(2) A resident having pressure sores receives necessary treatment and services to promote healing, prevent infection and prevent new sores from developing.

42 C.F.R. § 483.25(c)(emphasis added).

The "Quality of care" regulation also contains the following requirement:

(d) Range of motion. Based on the comprehensive assessment of a resident, the facility must ensure that-

(1) A resident who enters the facility without a limited range of motion does not experience reduction in range of motion unless the resident's clinical condition demonstrates that reduction in range of motion is unavoidable; and

(2) A resident with a limited range of motion receives appropriate treatment and services to increase range of motion and/or to prevent further decrease in range of motion.

42 C.F.R. § 483.25(e)(emphasis added).

The "Quality of care" regulation also directs the facility, with respect to an incontinent resident, that:

(e) Urinary incontinence. Based on the resident's comprehensive assessment, the facility must ensure that:

(1) A resident who enters the facility without an indwelling catheter is not catheterized unless the resident's clinical condition demonstrates that catheterization was necessary . . . . "

42 C.F.R. § 483.25(d)(1)(emphasis added).

Additionally, to provide the necessary care and services to enable the attainment and maintenance of each resident's highest practicable level of well-being, the facility must:

(a) Activities of daily living. Based on the comprehensive assessment of a resident, the facility must ensure that-

. . .

(3) A resident who is unable to carry out activities of daily living receives the necessary services to maintain good . . . grooming, and personal and oral hygiene."

42 C.F.R. § 483.25(a)(3)(emphasis added).

Another "Quality of care" requirement relevant to this case is the facility's obligation to ensure that --

(h) Accidents.

. . .

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

42 C.F.R. § 483.25(h)(2).

The "nursing services" regulation also interfaces with the content and purposes of the resident's assessment and plan of care. The regulation states that:

"[t]he facility must have sufficient nursing staff to provide nursing and related services to attain or maintain the highest practicable physical, mental, and psycho social well-being of each resident, as determined by resident assessments and individual plans of care."

42 C.F.R. § 483.30(emphasis added). Instead of setting forth specific numbers in the subsection titled "Sufficient staff," the regulation re-emphasizes that the facility:

" . . . must provide services by a sufficient number of each of the following types of personnel [e.g., licensed nurses and other nursing personnel] on a 24-hour basis . . . in accordance with resident care plans . . . ."

42 C.F.R. § 483.30(a)(1)(emphasis added, language added).

Words contained in the "Administration" regulation, which specify the minimum amount of training nurse aides must receive each year, also make clear that the regulation's intent is to benefit each resident, by setting forth requirements for which the facility should use its resources:

" . . . effectively and efficiently to attain or maintain the highest practicable physical, mental, and psycho social well-being of each resident."

42 C.F.R. § 483.75.

IV. Invalidity of Certain General Defenses Interposed by Petitioner.

The foregoing regulations indicate clearly that, even though there may exist differing opinions as to what could be considered "good" care or a "high quality" of care, the Secretary, United States Department of Health and Human Services (DHHS), has established the relevant criteria by rule-making for Medicare and Medicaid certified providers. Similarly, even though professional opinions may differ on questions such as whether pressure sores may be prevented from developing in certain segments of the population, the Secretary's promulgation of the regulation, at 42 C.F.R. § 483.25(c)(1), shows that she has taken notice through her rule-making authority that a distinction must be drawn between avoidable and unavoidable pressure sores for individuals residing in Medicare and Medicaid certified nursing facilities.(9) The regulations described above have created an inter-related set of functions which must be performed, timely and properly, by each participating facility to ensure that all of its residents will be to able to attain or maintain their own highest level of well-being. It not enough, therefore, that the participating facilities employ kind-hearted, well-intentioned staff members who attempt to make each resident as comfortable and injury-free as possible until the resident dies or is transferred. In considering the quality of care issue, the services and care delivered to residents in a participating facility cannot even be considered adequate unless that facility has acted in substantial compliance with all relevant regulatory requirements.

The regulations relied upon by HCFA preclude the facility from viewing the resident assessment process as a mere paperwork hurdle to be overcome before proceeding to do what it wishes for each resident. Nor should only "band-aid" solutions emerge from a properly performed comprehensive resident assessment. The appropriateness, adequacy, and quality of the care rendered to each resident living in a certified facility cannot be evaluated independent of the assessment(s) and the care plan completed for that resident. A certified facility will be able to deliver the care and services necessary to enable the resident "to attain or maintain the highest practical physical, mental, and psycho social well-being, in accordance with the comprehensive assessment and plan of care" (42 C.F.R. § 483.25(emphasis added), only if it has completed the assessments and care plans in the manner and within the time periods specified by 42 C.F.R. § 483.20. These inter-related regulations make clear that the resident assessment process must be done correctly and comprehensively so that the information gathered therefrom may then be reflected in the general and particular aspects of each individual care plan, according to which the staff members are to provide the care and services to which each resident is entitled to receive for attaining or maintaining his highest practicable level of well-being, as determined by the comprehensive assessment and resultant care plan.

Repeatedly in this case, Petitioner has misplaced reliance on its having generated certain pieces of paper in the assessment process. For example, because HCFA used Resident 1 from the August 1996 survey as an example of Petitioner's failure to comply substantially with the comprehensive assessment requirements of 42 C.F.R. § 483.20, Petitioner pointed out that it had filled out the required documents for this resident. Pet. Br., at 9. Petitioner objected to HCFA's finding that, because Petitioner failed to evaluate the use of a less restrictive device before using a "restraint" for Resident 1, the assessments done by Petitioner were therefore incomplete.(10) According to Petitioner, neither the regulations nor the content of the mandatory forms required the facility to conduct an assessment for the use of the least restrictive device. Id.

I find that, in setting forth these and similar arguments as defenses, Petitioner has overlooked the fact that the mere filling out of certain forms (or assigning particular titles to documents) does not establish that the assessment process was completed comprehensively or accurately for that resident's needs. Moreover, Petitioner's defenses disregard the fact that completion of the assessment process should lead to the formulation of an individual written plan of care that will enable each resident to receive services that will allow him to attain or maintain the "highest practicable physical, mental, and psycho social well-being . . . ." 42 C.F.R. § 483.25; 42 C.F.R. § 483.20(d)(emphasis added). I think these words in the regulations indicate with sufficient clarity that, if a resident needs to be restrained, a participating facility has an obligation to assess the extent and nature of the resident's individual need, and then assess for the use of the least restrictive device that would be appropriate and adequate for those needs. A facility cannot be considered to be delivering services that will enable the resident to attain or maintain his highest practicable level of well-being if the facility is restraining him unnecessarily, with use of unduly restrictive device(s) or to an unnecessary degree.

Petitioner complained also that it has been denied the ability to achieve substantial compliance with the relevant program requirements because the definition of "substantial compliance" is unlawfully vague. See, e.g., Pet. Br., at 83-87. I note that the regulations at issue direct Petitioner to serve the individualized needs of each resident in accordance with certain specified goals and methods. Accordingly, the definition of "substantial compliance" could not have been cast in terms of a mathematical equation.

The concept of "substantial compliance" is intended to tolerate a "reasonable degree of imperfection." 59 Fed. Reg. 56,226 (1994). Some human errors are bound to occur at times even when there exist the most perfectly drawn policies and procedures, and even where the most knowledgeable and dedicated staff is at work. However, to be tolerable for substantial compliance under the Medicare and Medicaid programs, the imperfections revealed pursuant to the survey process should be those that stemmed from minor oversights or errors in a few unrelated instances of insignificant potential consequences to residents, and for which the facility itself has procedures in place for promptly discovering and correcting those oversights or errors on its own initiative. Examples of imperfections that are not tolerable for substantial compliance are those that reflect the facility's inability to understand or effectuate its various obligations to care for its residents in accordance with the federal requirements. Such misunderstandings of its obligations have the potential for causing its residents, whether individually or as a group, to be deprived of those services which would enable them to attain or maintain their highest practicable level of functioning or well-being. Even though the facility may not cause deaths or immediately observable declines in most instances, by depriving its residents of services which would enable them to attain or maintain their highest practicable level of functioning or well-being, the lack of those services would have the potential for causing more than minimal harm over time to residents who have been admitted because they are incapable of maintaining what remains of their health on their own.

A facility's errors rise to the level of substantial noncompliance if the level of potential harm to residents is more than minimal. 42 C.F.R. § 488.301. Evidence of actual harm to residents is not required because the purpose of the enforcement scheme is protect the health of residents from unnecessary deterioration and to prevent the occurrence of more than minimal harm to them. The goal of the enforcement remedies is to have the noncompliance corrected before any greater degree of harm can occur, or before actual harm to residents becomes indisputable.

As a practical matter, the individuals who perform the surveying tasks have only the opportunity to obtain a snapshot view of conditions at the facility while they are on site for a limited number of days. They make personal observations on those days, and they take a sampling of the information made available by the facility's staff concerning the care delivered to residents who are often too ill and aged to communicate coherently. Therefore, as pointed out by Petitioner, the observations made by the surveyors tend not to be comprehensive, and the conclusions drawn by the surveyors do not prove conclusively that any act or omission by the facility has the potential for causing more than minimal harm to residents.

As an example, I note the defenses raised by Petitioner in response to the observations and conclusions concerning Resident 11 of the August 1996 survey. According to the Michigan State agency surveyor, Resident 11, who was incontinent and unable to perform the activities of daily living, had been placed at risk for sustaining fecal contamination in her mouth and for an eye infection because a nurse aide had administered a partial bed bath backwards, that is, by cleaning Resident 11's buttocks and perineum first, and then proceeding to clean the resident's face.

Petitioner's objection to the conclusion about the potential for fecal contamination was that the State agency surveyor did not observe whether Resident 11 was actually incontinent or "oozing stool" at the time of the partial bed bath. Pet. Br., at 32. Additionally, Petitioner complained that the surveyor also did not look to see whether Resident 11 was actually suffering from any eye infection or mouth infection. Id. Petitioner then offered, without any affirmative proof, the possibility that there might have been two separate wash cloths, so that during the period observed by the State agency surveyor, the nurse aide might have been washing Resident 11's buttocks and perineum with a wash cloth that was not re-dipped into the basin, and might have been using a separate wash cloth to wash Resident 11's face. Id. However, HCFA noted that, whether or not the nurse aide had used two wash cloths, the State agency surveyor was certain that the nurse aide did not change gloves or wash his hands during the administration of the bed bath to Resident 11. HCFA Br., at 29.

Petitioner's criticisms of the State agency surveyor's observations of the bed bath assumed wrongly that residents need to exhibit any measurable degree of suffering or injury in the presence of the surveyors. HCFA's response to those criticisms correctly highlighted the fact that noncompliance means the potential for causing more than minimal harm. Even the record in this case makes apparent that many nursing home residents suffer from long-term illnesses and slowly degenerating health problems. If these residents are denied services and care that would enable them to attain and maintain their highest practical level of well-being, the adverse consequences to them may be discerned by State agency surveyors only to the extent that the facility has maintained accurate, complete, and consistent records over time. However, facilities do not always maintain reliable records or leave a clear paper trail of their practices. As I discuss below, many problems in this case arose from Petitioner's maintenance of inconsistent, inaccurate, or incomplete records for individual residents.

Generally, it is with use of the information primarily provided by each facility concerning sample residents that surveyors must apply their best professional judgment to form reasonable conclusions about whether individual residents, or the resident population in general, have been placed at risk for sustaining more than minimal harm from practices which deviate from federal requirements. As the record in this case shows, the surveyors make such determinations as a team and only after they have given the facility opportunities to provide explanations or additional information on issues of concern to them throughout the survey process. When these judgment calls are made against a surveyed facility, the facility, like Petitioner herein, tends to raise the objection that no harm could have come to the residents due to the limited time span between the occurrence of the allegedly noncompliant practices and the changes that were instituted shortly after the problems were identified by the surveyors. I find objections of this nature to fall short of the mark. The objections fail to show a proper understanding of the facility's legal obligations when the surveyors are not present to make their findings.

Under the law, each certified facility has the obligation to protect the health and safety of its residents from being exposed to the risk of more than minimal harm. The facility's obligation exists whether or not surveyors are present. Therefore, a facility's prompt cessation of certain deficient practices in response to the surveyors' intervention does not, by itself, establish substantial compliance with program requirements.

It is true that surveyors cannot state with certainty the duration of any risks to residents prior to their arrival. Nor can anyone state with certainty for how long after the surveyors' departure the risk of harm to residents would have lasted if they had not intervened (e.g., by issuing a noncompliance citation, by inviting the submission of a plan of correction from the facility). However, it does not follow logically from such facts that the noncompliance citation should be reversed. Instead, the legally relevant inquiries should include whether the problems which placed residents at risk for more than minimal harm were the foreseeable consequences of the facility's established practices, and, moreover, whether the facility could have promptly discovered and eliminated the problems even if no compliance survey had been conducted.

For many of the foregoing reasons, I find legally untenable also Petitioner's approach of isolating each component of those regulations which are obviously inter-related by their wording and stated purposes, in order to argue that HCFA has failed to prove the requisite degree of harm to residents under each regulatory component.

For example, when faced with HCFA's evidence that certain resident assessments were flawed (either because certain required steps were skipped, completion deadlines were missed, or certain areas were omitted from the assessment documents), Petitioner took the position that HCFA cannot lawfully determine that there was a potential for more than minimum harm to the resident "without further evidence of a failure on the part of the facility to address the issues." Petitioner's Responsive Post-Hearing Brief (Pet. Rep. Br.), at 38-39. Using the example of Resident 9 from the August 1996 survey, Petitioner sought to apply this argument by pointing out that the resident's care plan includes services for his pressure sores and incontinence, which should, in Petitioner's view, be sufficient for showing that an assessment of these two areas had in fact been done. Id.

In submitting this argument, Petitioner has overlooked the function to be served by completing an assessment. Its argument misses the fact that proper and comprehensive written assessments must form the basis for the creation of any resident's care plan. The assessments are to be done in writing because unrecorded evaluations (even assuming that they have been done) cannot be verified for accuracy, timeliness or completeness. A facility's insertion of various services into a care plan does not prove that a comprehensive assessment has been done in writing, done accurately, and done before the creation of the care plan. Nor does the insertion of certain services in a care plan, in the absence of a comprehensive assessment, prove that those services are needed by the resident or appropriate to his condition.

As I will discuss in greater detail below, there are a number of instances where Petitioner was providing services for reasons that cannot be ascertained from the assessment documents either because those documents contain conflicting or inaccurate information, or because they are incomplete. While it is true that surveyors cannot pinpoint with precision the exact nature or degree of harm that will likely result to any particular resident from each failure to adhere to specific components of the comprehensive assessment process, the prevalence of a facility's failings under the assessment requirements may substantially erode the safeguards established by the regulations for the benefit of all residents. Therefore, a facility, like Petitioner herein, may properly be found to be out of substantial compliance with the assessment requirements even if the residents' care plans direct the provision of services which do not correspond to areas included in the assessment documents.

V. Petitioner's Failure to be in Substantial Compliance during the August 1996 and October 1996 Surveys.

I affirm HCFA's determination that Petitioner was out of substantial compliance with program participation requirements during the relevant time period in 1996. I do so by issuing the following formal findings of fact and conclusions of law (FFCLs).

FFCL #1. For the survey conducted during August 1996, HCFA has proved by a preponderance of the evidence that Petitioner was out of substantial compliance with the requirements to:

A. conduct comprehensive, accurate, and timely assessments of requisite frequency for each resident in accordance with 42 C.F.R. § 483.20(b) and 42 C.F.R. § 483.20(b)(4);

B. develop comprehensive and timely care plans for each resident in accordance with 42 C.F.R. § 483.20(d);

C. deliver quality care to each residents by:

1. preventing the development of avoidable pressure sores and providing necessary treatment and services to promote healing of existing sores (42 C.F.R. § 483.25(c));

2. providing necessary grooming and personal and oral hygiene to each resident who is unable to independently carry out activities of daily living (42 C.F.R. § 483.25(a)(3));

3. providing appropriate services to increase, or prevent decrease of, each resident's range of motion (42 C.F.R. § 483.25(e)(2)); and

4. not using an indwelling catheter for any resident unless necessary (42 C.F.R. § 483.25(d)(1)).

FFCL #2. For the survey conducted during August 1996, HCFA has not proved by a preponderance of the evidence that Petitioner was out of substantial compliance with the staffing requirements of 42 C.F.R. § 483.30(a)(1) and (2).

FFCL #3. For the survey conducted during August 1996, HCFA has not proved by a preponderance of the evidence that Petitioner's failure to comply substantially with program requirements have caused actual harm to any resident.

FFCL #4. For the revisit survey conducted during October 1996, HCFA has proved by a preponderance of the evidence that Petitioner remained out of substantial compliance with:

A. the comprehensive assessment requirements of 42 C.F.R. § 483.20(b);

B. the care plan requirements of 42 C.F.R. § 483.20(d); and

C. the quality of care requirements of 42 C.F.R. § 483.25, in so far as they entitle each resident to receive:

1. apprpriate services for the prevention and treatment of pressure sores(42 C.F.R. § 483.25(c);

2. adequate supervision and assistive devices to prevent accidents (42 C.F.R. § 483.25(h)(2)); and

3. no unnecessary drugs (42 C.F.R. § 483.25(l)(1))(Tag F329).

FFCL #5. For the October 1996 revisit survey, HCFA proved by a preponderance of the evidence that Petitioner was also out of substantial compliance with the portion of the "Administration" regulation which governs the amount and frequency of in-service training for nurse aides (42 C.F.R. § 483.75(e)(8)).

FFCL #6. For the October 1996 revisit survey, HCFA did not prove by a preponderance of the evidence that Petitioner's failure to be in substantial compliance with participation requirements had caused actual harm to any resident.

Below, I will structure my discussions of these FFCL by individual residents. However, not every resident identified by HCFA will be discussed because Petitioner's omissions and failings were not unique to each resident. Instead, Petitioner's omissions and failings occurred in a pattern and for similar reasons. Therefore, it would be redundant and unnecessarily time-consuming to describe what was experienced by each resident in the surveyors' sample group and the potential consequences to each. Additionally, given the apparent commonality of causes for the problems discovered in individual residents' records, there also existed the potential for more than minimal harm for the remaining resident population, whose records were not reviewed as samples during the surveys. The facts concerning the sampled residents will be analyzed to the extent necessary to resolve the issues of whether HCFA had a basis for imposing the CMP and whether the rates of the CMP are reasonable.

I have already rejected some of the arguments set forth by Petitioner. Petitioner has submitted other lines of argument as defenses to other findings made by HCFA. Even though Petitioner applies these defenses to parts of HCFA's findings concerning various residents' situations, I will not separately discuss them for each resident. I have already explained previously why I do not find it appropriate to adopt Petitioner's approach of separately parsing the regulatory requirements when they form parts of a whole. For the same reasons, I think the greater significance to what HCFA has introduced and what Petitioner has argued as defenses thereto lies in the patterns created by showing what has occurred or has failed to occur. I recognize that, by applying its defenses repeatedly but only in response to specific findings made by HCFA, Petitioner is seeking to have me look at each problem that has been identified by HCFA as if it existed in isolation and was caused by unique circumstances. Since the inferences created by Petitioner's methods are not consistent with the evidentiary record as a whole or the content of the regulations, I do not think it necessary to discuss the merits of the defenses at all of the junctures Petitioner has raised them.

In this case, there was a series of similar, related, or recurring problems found during the August 1996 survey and the follow-up survey of October 1996, which show that, more probably than not, Petitioner was out of substantial compliance with the comprehensive assessment and care planning requirements, as well as with various portions of the "Quality of care" regulation. The majority of these problems were discovered by the Michigan State agency surveyors by reviewing the records maintained by Petitioner. The problems lead reasonably to the conclusion that Petitioner, as an entity, has either failed to understand or to properly implement timely, its obligations to enable each of its residents to attain and maintain his highest individualized level of well-being.

Even if the problems could be attributed to the failings of individual staff members, the record does not disclose that only a small number of identifiable staff members were the responsible persons. Instead, the prevalence and illogical nature of the problems identified against Petitioner, together with the fluctuating arguments used by Petitioner to explain only certain parts of its staff's actions, support the conclusion that Petitioner allowed its staff to apply their idiosyncratic approaches ad hoc, when Petitioner should have had uniform procedures for its staff to implement consistently, together with certain safeguards to ensure against deviations from those procedures. Nor does the information introduced as defenses by Petitioner credibly establish the existence of any system which would have enabled the facility to detect and correct its own mistakes promptly had the Michigan State agency surveyors not intervened.

A. Discussion of FFCL Nos. 1 and 3.

1. Resident 2 of the August 1996 Survey.

With the use of the evidence concerning Resident 2, HCFA proved Petitioner's failure to comply substantially with various material components of:

-- 42 C.F.R. § 483.20(b) ("Comprehensive assessments");

-- 42 C.F.R. § 483.20(d) ("Comprehensive care plans");

-- 42 C.F.R. § 483.25(c) (delivering services to prevent and treat pressure sores ).

For Resident 2, Petitioner failed to comply with the requirements for completing the assessments timely, comprehensively, and with accuracy. As specified by 42 C.F.R. § 483.20(a)-(c), Petitioner had 14 days after admitting Resident 2, on May 29, 1996, to complete for her the requisite written assessments that were comprehensive, accurate, standardized, and reproducible in all of the specified functional areas. Not only does the comprehensive assessment process contemplated by the regulation require each health care professional who fills out a portion of the assessment documents to sign and certify the accuracy of that portion, but also that the assessment be conducted or coordinated by a registered nurse who must, in turn, sign and certify that the resident's assessment has been completed. 42 C.F.R. § 483.20(c). The completion of the initial assessment process within 14 days of the resident's admission should then result in the development of a comprehensive care plan for that resident within seven (7) days thereafter. 42 C.F.R. § 483.20(d). Since, under 42 C.F.R. § 483.20(d), a care plan must be developed on the basis for the information recorded by the facility on the assessment documents, the requirements that the information contained in the assessment documents be read and then certified for accuracy and completeness by the responsible individuals have practical significance for the care to be received by each resident.

The relevant dates appearing on the assessment documents generated by Petitioner for Resident 2 lead to the conclusion that the assessments were not performed and completed in accordance with the regulatory requirements after Resident 2's admission to the facility on May 29, 1996. The inconsistent information and dates appearing in different parts of Petitioner's records do not correlate logically to what is specified or intended by 42 C.F.R. § 483.20. As noted by HCFA, June 27, 1996 appears on the Minimum Data Set (MDS) form(11) generated by Petitioner for Resident 2. The placement of the June 27, 1996 date indicates that the MDS was being signed and certified as having been completed on that date. HCFA Exhibit (Ex.) 40, at 16. However, a progress note introduced into these proceedings would indicate that the MDS for Resident 2 had been completed on June 6, 1996. Petitioner Exhibit (Pet. Ex.) 11, at 1.

According to Petitioner, quoting from one of its exhibits, there was a "transposition error original MDS dated 6/6/96 but on wrong form." Pet. Br., at 8 (citing Pet. Ex. 9, at 7). Petitioner has not persuasively established any relationship between the alleged "transposition error" and the dates of either June 6, 1996 or June 27, 1996 appearing in its records. Nor does it appear logical that any "transposition error" on the date should cause Petitioner's staff to create a new document several weeks later -- especially given Petitioner's intimations that the same information found on the "wrong form" had merely been transferred onto the correct form, and, therefore, the June 6, 1996 date should count instead of the June 26, 1996 date.

Additionally, Petitioner's argument that it had completed an MDS "equivalent" form on June 6, 1996 is inconsistent with other dates contained in the other records generated by Petitioner in completing Resident 2's comprehensive assessment substantially outside of the 14 days post-admission allowed by 42 C.F.R. § 483.20(b). As also pointed out by HCFA, although Resident 2 was admitted on May 29, 1996, the date July 9, 1996 appears as the date on which the nursing component of the assessment was signed and certified as having been completed. HCFA Ex. 40, at 25. Further, information Petitioner had placed on the MDS form indicated that additional, more detailed written evaluations of Resident 2's communication needs, activities of daily living, psycho social needs (including the use of psychoactive drugs), and potential for falls should have been completed in writing in accordance with the RAP process within 14 days of her admission to meet the comprehensive assessment requirements. See HCFA Ex. 40, at 12-16. However, Petitioner did not complete the RAP assessments for Resident 2 in these "triggered" areas until July 19, 1996. HCFA Ex. 71, at 25.(12) Also according to the report filed by the surveyors, they were told by the staff member they questioned about Resident 2's records that assessments were not always done in a timely manner. HCFA Ex. 71, at 26.

Petitioner responded that HCFA's use of the July 19, 1996 date was erroneous because the facility's staff members were under no legal obligation to record the "triggered" RAP assessments together or in any document marked as "RAP" assessments. Pet. Br., at 8. Petitioner referred to parts of its clinical records for Resident 2 to allege that the necessary RAP assessments were in fact done and done timely. See Pet. Br., at 8-9.

I find Petitioner's explanation unpersuasive and disingenuous. The evidence of record fails to establish the existence of any uniformly applied practice or policy whereby, for every resident in its facility, Petitioner's staff wrote down the necessary RAP assessments in separate and different places on documents which do not indicate that they contain RAP assessments. Moreover, the explanation provided by Petitioner appears strained when considered in light of the fact that recording all of the RAP assessments for each resident in the same document denoted as such would benefit the residents by making all of the relevant information easily accessible for the formulation of an individualized care plan. In contrast, Petitioner's alleged exercise of an asserted right to record RAP assessments in different places without clearly identifying them as such for each resident would have served the convenience of staff members who likely had the mistaken view that their performance of RAP assessments was a discrete, "paper compliance" formality. Moreover, Petitioner's alleged exercise of its right to not have clear and consistently applied record-keeping procedures would unnecessarily increase its staff's opportunity to make mistakes through oversight during the assessment process.(13)

The flaws in Petitioner's information gathering and record-keeping methods for completing resident assessments are shown also by HCFA , using Resident 2's records as examples, under the portion of the "Quality of care" regulation governing the prevention and treatment of pressure sores. 42 C.F.R. § 483.25(c). HCFA showed that the records maintained by Petitioner for Resident 2 contained conflicting information about the condition of her left heel upon her admission to the facility and at various junctures before the survey was conducted on August 6-9, 1996. During those days, the surveyors saw that Resident 2 had a Stage IV pressure sore on her left heel.(14) The conflicts in Petitioner's records had not been identified or resolved by Petitioner with use of the assessment process. Instead, Petitioner had generated assessments that were inaccurate or incomplete as well as untimely, which resulted in an inappropriate or inadequate care plan and Petitioner's failure to deliver the services needed by Resident 2 under 42 C.F.R. § 483.25(c).

During and after the hearing in this case, Petitioner has indicated its disagreement with and inability to understand various pieces of information maintained in its records for Resident 2. See, e.g., Pet. Br., at 47-48. Even though Petitioner has implicitly acknowledged the confused state of its own records, its tacit admission regarding the state of its records does not suggest that Petitioner was in substantial compliance with the relevant regulations. Nor has substantial compliance been shown by Petitioner's present efforts to give favorable interpretations to select pieces of information isolated from the total body of conflicting records it has generated or maintained.

The appropriate time for Petitioner to have raised questions about the accuracy of doctors' notes and other records concerning Resident 2 was when it was conducting the assessments of this resident. Raising the questions and obtaining resolutions to conflicting information during the assessment process would have been consistent also with Petitioner's obligation to ensure that Resident 2 attain and maintain her highest practical level of well-being through the crafting of an appropriate care plan for the timely delivery of needed services.(15) Petitioner's present efforts to sift through its various records to cull out only the allegedly accurate information for Resident 2 are responses to litigation, and those efforts come too late to be of benefit to the resident.

About the only fact the parties have agreed upon is that Resident 2 was admitted by Petitioner on May 29, 1996 with an external fixative device to treat her broken left ankle. Petitioner's Unit Manager, Donna Enochs, R.N., testified that the "external fixator" worn by Resident 2 had been attached to below her knee on or about May 5, 1996. Transcript (Tr.) 674. The "fixator" was "a metal device that had pins that screwed directly into the skin, to fixate into the bone. It's to help a fractured heel without casting it." Id. When Ms. Enochs paid a visit to Resident 2 immediately before Petitioner admitted her, Ms. Enochs observed that there was gauze around the outside edges of the fixative device, because "where the pins went directly into the skin, they wanted to make sure it stayed covered." Id.

Surveyors on the August 1996 survey attempted to ascertain from Petitioner's records the onset and development of the pressure sore that had deteriorated to Stage IV by the time they saw it. The surveyors found that Petitioner was maintaining inconsistent and inaccurate records which failed to show reliably whether a pressure sore had been on this resident's left heel when Petitioner admitted her, and, if not, when the pressure sore first appeared after admission. Specifically, the surveyors found some documents which indicated that Resident 2 had exhibited no skin problems on her left heel when Petitioner admitted her. However, there are also other records showing that Petitioner had either failed to note the existence of a left heel ulcer at the time of this resident's admission, or Petitioner had failed to observe (or had failed to record accurately) when the left heel ulcer developed during the course of her stay.

Petitioner argues that HCFA's finding of noncompliance is flawed because "conspicuously absent from the HCFA 2567L [the report of the Michigan State agency surveyors] is information which indicates that Resident 2 was, in fact, admitted to the facility with the area [of skin ulcer] on her left heel." Pet. Br., at 46. Petitioner then argues, seemingly in the alternative, that "HCFA 2567L is misleading in that it creates a picture of a resident who is admitted with clear skin and within a very short period of time developed a Stage IV pressure sore." Id. Aside from their apparent inconsistencies, the substance of these arguments is without merit.

The Michigan State agency surveyors were not at the facility to look at this Resident's heel when she was admitted by Petitioner on May 29, 1996. It was Petitioner's staff, not the State agency surveyors, who had the opportunity and obligation to create accurate records when admitting this resident, when assessing her, when formulating a care plan for her, and when delivering services to her each day. The State agency surveyors drew the conclusions they did from their review of the inconsistent and unreliable records maintained by Petitioner. I am not, however, bound by the conclusions of the Michigan State agency surveyors, and I explain below my own findings about Petitioner's noncompliance even though the information provided by Petitioner does not enable me to determine whether Resident 2 was in fact admitted with clear skin, nor how the left heel ulcer that developed and progressed to Stage IV by early August 1996.

Under the regulatory scheme, if indeed no pressure sore had been present at the time of Resident 2's admission, then Petitioner should have done the required initial comprehensive assessment and care plan, and delivered services accordingly, to avoid the development of pressure sores in this resident, who should have been considered at risk due to her wearing of the external fixative device with pins which screwed into her skin, as well as due to her other conditions noted in various assessment documents.(16) If the pressure sore at Stage IV severity seen by the surveyors on August 6, 1996 had developed before or after Resident 2's admission on May 29, 1996, then Petitioner should have clearly and accurately recorded the relevant information (including the date of onset, if after admission), so that an assessment and care plan could be timely completed to ensure the delivery of services that would prevent deterioration and enable healing of that sore. Given the inconsistent, unreliable, and incomplete information in Petitioner's records, it is not even possible to determine when the assessments and care plan to prevent deterioration of the sore should have been completed for Resident 2.

Specifically, the History and Physical Report completed by a physician on this resident's admission stated that she had no skin breakdown;(17) the content of the MDS completed by Petitioner on June 27, 1996 indicated the absence of any skin ulcers; and the portion of another physician's notes stated that, as of July 4, 1996, when the external fixative device was being removed, there was no ulcer seen on this resident's heel. HCFA Ex. 40, at 10, 15-17. In addition, the Michigan State agency surveyors found no indication of a pressure sore or skin ulcer on a nursing assessment signed July 9, 1996. HCFA Ex. 40, at 24-25.

However, there was contradictory information on or about the same dates in Petitioner's records as well. The contradictory information did not cause Petitioner either to change the MDS dated June 27, 1996, or to generate a new, updated MDS, to indicate, instead, the presence of a skin ulcer.

For example, as noted by Petitioner, the nurses recorded on May 30, 1996 that "Left heel noted to be soft with blackened area. Heel elevated off bed." Pet. Br., at 25 (citing Pet. Ex. 18). Petitioner noted also Dr. VanOosterhout's written order that the resident's heel be elevated on a pillow. Id. There was also a progress note from Dr. VanOosterhout which indicated the debriding of an ulcer on this resident's left heel on June 4, 1996. HCFA Ex. 40, at 21. There was a record that Dr. VanOosterhout had ordered dressing and gauze for this resident's left heel ulcer on June 4, 1996, and Petitioner's staff began applying adaptic dressing to a Stage II ulcer on June 5, 1996. See Pet. Ex. 20, at 3; HCFA Ex. 40, at 27.

There was also a physician's progress note showing that a Stage IV ulcer on Resident 2's left heel, 3 cm. by 3cm. in size, was debrided on July 19, 1996. HCFA Ex. 40, at 17. A portion of the physician's progress note dated July 22, 1996 indicated also that she had a skin ulcer as of that date. HCFA Ex. 71, at 36. However, not even Petitioner's documents specifically titled "Pressure Sore Avoidability Records" contain consistent and facially reliable information on the questions of whether the left heel ulcer developed after admission, and if so, as of which date.

A Pressure Sore Avoidability Record dated July 8, 1998 stated that Resident 2 was admitted to the facility with a pressure sore, even though, as noted previously, the MDS completed by Petitioner on June 27, 1996 indicated the contrary. Moreover, another Pressure Sore Avoidability Record generated by Petitioner on August 5, 1996, just one day before the surveyors' arrival, again stated that when Resident 2 was taken to Unit B of the facility upon her admission, she had clear skin; however, when she was later transferred to Unit C on July 17, 1996, she had a necrotic area three inches in diameter on her left heel. HCFA Ex. 40, at 26. Nevertheless, someone on Petitioner's staff added the contradictory information on the August 5, 1996 document, stating that a pressure wound was present on admission and, in addition, the resident's transfer to Unit C took place on July 23, 1996 instead of July 17, 1996. If the July 23, 1996 date were accepted as the date on which Resident 2 had been moved to Unit C, then that information would render inaccurate and unreliable the content of a physician's note dated July 22, 1996, which indicated that the resident had a left heel sore as of that date, and that the staff of C Unit already had care of this resident as of July 22, 1996 because they said the sore was there when she arrived at that unit.

After the surveyors noted the Stage IV pressure sore on Resident 2's left heel on August 6, 1996 and cited the facility for noncompliance with various participation requirements, Petitioner attempted to defend the state of its records by alleging that Resident 2 did have a black eschar (necrotic or dead tissues) on her left heel at the time of her admission, but Petitioner did not record or address the eschar in the resident's assessments. According to Petitioner, eschars cannot be entered on the MDS because they are not "stageable" like ulcers are. See, e.g., Tr. 675, 915; Pet. Ex. 18, at 2. Taking these assertions to their logical conclusion would mean that Petitioner's failure to enter the skin problem on Resident 2's left heel on the MDS form would have resulted in the failure to assess the problem in detail as a "triggered" area under the RAP process; the absence of any RAP assessment for the left heel skin problem as part of Resident 2's comprehensive assessment would have then led to Petitioner's failure to place into this resident's care plan the appropriate treatment, together with measurable timetables and objectives, for her left heel skin problem. In fact, however, Petitioner performed a pressure ulcer RAP on July 19, 1996 by identifying a right heel ulcer, when the ulcer was in fact on this resident's left heel. HCFA Ex. 40, at 41.

To specifically counter Petitioner's argument concerning its inability to assess the eschar on Resident 2's left heel, HCFA has shown by witness testimony and with its Exhibit 27(18) that the written instructions issued to long-term care providers for the use of the MDS specifically states that eschars can and should be assessed as an ulcer on the MDS form.(19) The User's Manual explains how to assign stages to eschars. See HCFA Br., at 15 (citing HCFA Ex. 27, at 41). Moreover, even if Petitioner had thought that the MDS form only permits the entry of skin ulcers in specific stages, I have noted above the fact that Petitioner had in its records not only Dr. VanOosterhout's notes showing that he had debrided an ulcer on this resident's left heel on June 4, 1996, but also records showing that on June 5, 1996, its own staff had applied dressing to what was considered a Stage II ulcer after debridement as ordered by the physician. Therefore, Petitioner had information of this resident's ulcer before its completion of the MDS form on June 27, 1996. Petitioner's Unit Manager, Donna Enochs, R.N., testified also that when she visited Resident 2 in the hospital immediately prior to Petitioner's admitting her for long-term care, she wrote down in her own notes that Resident 2 had a "stage 3, silver dollar-size area to her left heel covered with Duoderm"(20) -- thereby not only contradicting its arguments about eschars and the its staff's inability to assign stages to eschars, but further highlighting the unreliable, inaccurate, and noncompliant state of the assessment records, which prevented Resident 2 from receiving the services intended by the "Quality of care" regulation for the prevention or improvement of her pressure sore.

Even if Petitioner had considered the condition on Resident 2's left heel an eschar at the time of admission on May 29, 1996, the condition should not have deteriorated to a Stage IV skin ulcer by the time of the August 1996 survey without Petitioner's having noted it, assessed it in writing, developed an appropriate care plan setting forth measurable goals and timetables for its treatment in writing, and delivered services in accordance with the written care plan, during the intervening months. No care for the skin on Resident 2's left heel had even been entered on her care plan until July 24, 1996, nearly two months after her admission. The care for the skin ulcer entered at that time consisted of hydrotherapy treatment. HCFA Ex. 71, at 36. The resident's care plan reviewed by the Michigan State agency surveyors during August 1996 did not show that Petitioner had thought there should be nursing intervention or dietary intervention for the treatment of the left heel ulcer. Id.

Also according to HCFA, Petitioner had no written care plan for Resident 2's left heel until July 29, 1996. See HCFA Ex. 40, at 42. HCFA specifically noted that even though the heel problem had been mentioned in a document generated by an individual discipline dated a few days before July 29, 1996, the regulation requires the facility's interdisciplinary team to generate a written comprehensive care plan after the assessment process has been completed. HCFA Br., at 56 n.65. Therefore, HCFA used July 29, 1996 as the date Petitioner mentioned heel care for Resident 2 in an untimely completed care plan.

HCFA sought to prove also that Petitioner's failure to complete Resident 2's assessments and care plan in a timely, accurate, and comprehensive manner had adverse consequences for other aspects of this resident's condition as well. In addition to the example of her left heel, HCFA noted that Resident 2 had also shown declines in her activities of daily living and psychosocial adjustment during the delays caused by Petitioner.(21) Occupational therapy was discontinued for her on July 1, 1996 because the decline in her mental status had made this endeavor inappropriate. Petitioner's records stated that her confusion "has drastically increased [,] and she has become dependent for self-care." HCFA Ex. 40, at 72-73. Resident 2 also experienced at least six (6) falls after her admission. Between June 12, 1996 and July 8, 1996, the falls were reported usually after she was found on the floor; on one occasion she was seen with half her body on the bed and half off while wearing a wrist restraint; on another occasion, she was seen attempting to get out of her bed. Pet. Ex. 18. She was even restrained in her bed in order to prevent her from pulling out her IV and catheter tubes. Pet. Ex. 20, at 33.

For Resident 2, Petitioner did not timely complete the necessary RAP assessment for falls. Nor did Petitioner complete the RAP assessments for falls accurately by July 19, 1996, when it purports to have done so. Petitioner's failure to mention this resident's six recent falls in the July 18, 1996 falls RAP not only shows the incompleteness of the assessment process, but also casts doubt on the validity and usefulness of the resultant care plan that was generated by Petitioner.

Petitioner asserts as a defense that, on different days, it has various pieces of paper containing information about the care Resident 2 was to receive for different conditions. Pet. Br., at 25-26. Petitioner argues that a "care plan" should not be construed as one discreet document, since there is no federal requirement for placing all of the relevant information together or for labeling it clearly as a "care plan." According to Petitioner, its clinical records addressed Resident 2's needs and the services to be rendered to her even though there may have been technical noncompliance with 42 C.F.R. § 483.20(d). Therefore, Petitioner disputes that the resident's health was placed at risk.

I do not find Petitioner's arguments persuasive or legally sound. The regulations mandate adherence to certain procedures for the safeguarding and, if possible, the enhancement of each resident's health or well-being. What Petitioner relies upon is the information provided by different care givers in the clinical records before the completion of the assessment process. That information does not satisfy the legal definition of a "care plan." Similarly, before the interdisciplinary team of requisite composition has prepared a document containing the information specified in 42 C.F.R. § 483.20(d), the writings of the staff cannot be considered a "care plan" within the meaning of the law. The comprehensive care plan required by law is the one that is generated by the interdisciplinary team specifically addressing the outcomes of resident assessments which should have been concluded accurately and completely.

Of course each resident must receive interim care while the assessment and care planning processes are on-going. However, interim care is provided on the basis of each individual discipline's knowledge before the resident's needs have been properly ascertained, and before a comprehensive care plan required by 42 C.F.R. § 483.20(d) has been finalized by the interdisciplinary team that has reviewed all of the residents' needs. Petitioner's approach improperly anticipates the content of the comprehensive plan of care before the proper procedures have been followed, and before all the required professionals have given their input.

Like its ad hoc approaches to labeling only some RAP assessments as such and placing together the RAP assessments for only some residents on discreet documents denoted as such, Petitioner has not shown that it has been consistently exercising its alleged legal right to refuse labeling documents as "care plans" for all its residents. There is no credible evidence showing that the problems identified by HCFA for Resident 2 resulted from the intentional and informed choices made by Petitioner's staff. Instead, the lack of consistency makes it appear more likely than not that Petitioner's staff was failing to adhere to the requirements of 42 C.F.R. § 483.20(d) because: (1) they found it more convenient not to do so on occasions; (2) they lacked sufficient knowledge of the regulatory requirements to apply them consistently; or (3) Petitioner had not established uniform procedures for its staff to follow.

For all of these reasons, I agree with HCFA that the health and well-being of Resident 2, as well as that of other residents,(22) has been placed at risk for more than minimal harm by the staff's failure to implement the "resident assessments" and "comprehensive care plan" requirements in a timely and correct manner. Petitioner's failure to comply substantially with these requirements then contributed to its noncompliance with its obligations under 42 C.F.R. § 483.25(c) to deliver services that are appropriate to the prevention or treatment of the pressure sore on Resident 2's left heel.

The preponderance of evidence does not support HCFA's contention that Resident 2 "suffered actual harm when she failed to receive care planned treatment to prevent the development or worsening of a pressure ulcer on her heel." HCFA Br., at 14. However, the evidence more than sufficiently establishes that Petitioner's failings after Resident 2's admission, under all three requirements, placed her at risks for sustaining very serious physical harm and discomfort.

2. Resident 10 of the August 1996 Survey.

HCFA's use of the evidence concerning Resident 10 supports its conclusions that Petitioner was out of substantial compliance with the following requirements:

-- 42 C.F.R. § 483.20(b) ("Comprehensive assessments"); and

-- 42 C.F.R. § 483.20(d) ("Comprehensive care plans").

However, HCFA has not shown Petitioner's noncompliance with the staffing requirements of 42 C.F.R. § 483.30(a) using evidence concerning Resident 10.

In proving Petitioner's noncompliance with the assessment and care plan requirements, HCFA has identified significant problems in the records maintained or generated by Petitioner for Resident 10. These problems are similar to those encountered in Resident 2's records.

Resident 10 had an indwelling urinary catheter. HCFA concluded after a review of the relevant documents that Petitioner had not done a comprehensive assessment of why the catheter was necessary, nor of the circumstances which would permit its removal. HCFA explained, with use of testimony by one of the Michigan State agency surveyors, Karen L. Boyer, that, even though various conditions might warrant the insertion of a catheter, it is important to assess which condition warrants the insertion of a particular catheter. Knowing the particular reason for using the catheter would also affect the contents of the resident's care plan insofar as establishing the requisite goals and timetables, and determining when the catheter should be discontinued. Tr. 341-343. An indwelling catheter should not be inserted as a matter of routine or for longer than necessary because it creates a risk for infection and it may also impair the individual's ability to regain normal bladder functions. Tr. 343. Additionally, each time the catheter is changed, there is a risk of infection as well. Tr. 280-281. Therefore, if an indwelling catheter is needed, it should not be changed more frequently than necessary. Id. The opinions provided by the surveyor were not substantially controverted by Dr. VanOosterhout, who testified for Petitioner and attempted to reconcile certain information concerning Resident 10's catheter. See Tr. 1019-1022.

The evidence of record established that, at the time of the August 1996 survey, Petitioner's staff did not even have consistent information about the condition for which the catheter had been inserted. Whereas one of Petitioner's records, a physician's progress note, indicated that the catheter was placed in response to the resident's neurogenic bladder, Surveyor Boyer was told that the catheter had been inserted to facilitate the healing of a herpes infection. Tr. 277, 320, 690; Pet. Ex. 73, at 1-2. A RAP assessment for this resident dated March 27, 1996 did not mention a neurogenic bladder or a herpes infection. The RAP assessment stated only that the catheter was necessary due to skin excoriation secondary to continual urinary dribbling. See Tr. 277-278. Additionally, in response to the questions raised during the survey about Resident 10's indwelling catheter, Petitioner's unit manager looked at the medical records and stated that this resident had also a history of bladder cancer and a history of episodic urinary retention. Tr. 277. This resident's complete medical history was not reflected in the written assessments for the catheter, according to HCFA.

In its Post-Hearing Reply Brief, Petitioner relies on the hearing testimony of Dr. VanOosterhout to argue that "it is obvious then that the catheter was inserted to prevent the dribbling [which could have been caused by a neurogenic bladder] so that skin excoriation could heal." Pet. Rep. Br., at 40 (citing Tr. 1020-1021). I do not find Petitioner's argument to be persuasive. This physician's testimony did not respond to all the significant problems presented by HCFA's evidence.

As HCFA pointed out, even assuming that the catheter had in fact been inserted to relieve skin excoriation caused by continual urinary dribbling, the staff member in charge of Resident 10's care was unable to tell Surveyor Boyer whether assessments had been done on the cause of the continuous dribbling, such as urinary retention. See HCFA Br., at 47-48, including citations noted therein. Petitioner does not allege that any written assessment had been done of the causes for this resident's dribbling. See Pet. Br., at 21-22; Pet. Rep. Br., at 40.

It is evident from the record before me that Dr. VanOosterhout's opinion concerning the possible relationship between a neurogenic bladder and dribbling was not provided during the assessment period or during the August 1996 survey. Therefore, his testimony at the hearing had no bearing on the insertion or the maintaining of a catheter in Resident 10, the intended beneficiary of the comprehensive and written assessment procedures mandated by 42 C.F.R. § 483.20. Moreover, Surveyor Boyer indicated that the usefulness of the inserted catheter as a response to continual dribbling, however it might have been caused, had not been properly evaluated. Such an assessment was needed because the catheter was leaking and required constant changes. Tr. 282, 341. Resident 10 was pulling out the catheter, and there was leakage. Id.(23)

In addition to showing the potential risks of infection and loss of bladder functions when a catheter is inserted unnecessarily or kept in for an unwarranted length of time, HCFA also showed that Resident 10 had likely experienced more than minimal discomfort when Petitioner repeatedly changed the catheter as a consequence of having failed to properly assess its purpose in the first instance, as well as having failed to place into the care plan the information needed for the delivery of appropriate care to her. First, HCFA demonstrated the basis for concluding that Resident 10 had shown agitation during catheter care. See HCFA Br., at 56. Using information contained in Petitioner's records, HCFA noted as an example the events of May 2, 1996, when a new catheter was inserted after three attempts with the assistance of three staff members, and, subsequently, it was determined by Petitioner's staff that Resident 10 should be sedated for future catheter changes. Id. (citing Pet. Ex. 74, at 3). There were additional reports of this resident's agitation, combativeness, biting and other manifestations of her resistance to pericare during June and July, 1996. HCFA Br. at 56 (citing Pet. Ex. 74, at 5-6, 9-10).

HCFA concedes that Petitioner did state in its written assessment of Resident 10 that she was resistant to care and that Petitioner's staff did provide information concerning the interventions they had instituted in trying to lessen or overcome this resident's resistance, e.g., using a baby doll as a distraction, talking to her, touching her to calm her. HCFA Br., at 56 n.67. However, HCFA has also noted the problems with Petitioner's information under the regulatory framework. Petitioner's reliance on its assessment that Resident 10 was resistant to care improperly implies, without the necessary underlying assessment data or analysis by Petitioner, that this resident needed the care she was resisting. What Petitioner did was attempt to curtail her resistance in order to continue delivering care of questionable usefulness. Therefore, it cannot be concluded that any pain or discomfort caused to Resident 10 by Petitioner's delivery of such care, or by Resident 10's resistance to such care, was appropriate for the improvement or maintenance of her health. Additionally, as also pointed out by HCFA, the written care plan for this resident does not include any of the interventions Petitioner's staff had used in their attempts to lessen or eliminate her resistance.

I find that the incompletely prepared care plan in this instance constitutes more than a merely technical violation of 42 C.F.R. § 483.20(d), as argued by Petitioner. Instead, Petitioner's failings have unnecessarily caused Resident 10 actual and not insignificant discomfort over time.

Leading to the foregoing conclusion is also the evidence showing that, as in most nursing homes, the day-to-day care of residents at Petitioner's facility was provided by LPNs and nurse aides, some of whom were Petitioner's employees and some of whom were obtained from outside agencies. No higher level health care professional from the facility accompanied these care givers each day as they performed their routine work. Additionally, not all care-givers, even if they held the same certificates, had the same amount of knowledge, the same level of industriousness, or the same degree of familiarity with the residents -- especially when some of the staff was obtained by Petitioner from an agency on an as-needed basis. Therefore, the care provided to residents by the care givers is supposed to follow the written comprehensive care plans prepared by an interdisciplinary team of health care professionals, and the plan needs to contain information, such as which of various possible interventions should be implemented, for how long the interventions should be attempted, and what criteria are to be used for the staff to determine whether to continue (or discontinue) the particular interventions. When the care plans contain the required information in writing, the residents have safeguards against receiving inconsistent, improper, inadequate, or unnecessary care from their daily care givers, who lack the professional knowledge of the interdisciplinary team responsible for preparing each resident's comprehensive plan of care.(24)

Here, even assuming that Resident 10 was actually in need of the care she was resisting, Petitioner could have had its interdisciplinary team include the necessary information (in the care plan) on the intervention efforts to be implemented by the care givers to reduce or eliminate that resistance. Petitioner has failed to show any good reason for the failure to include such information in the written care plan as required by 42 C.F.R. § 483.20(d). Petitioner's defense is that, at the very worst, it made various mistakes on paper which were of no consequence to Resident 10. I do not find Petitioner's arguments persuasive in light of HCFA's showing that, while receiving care that had not been properly assessed to be necessary and notwithstanding the staff's assertions that they were trying their best (without guidance from the comprehensive care plan) to curtail her resistance to care, Resident 10 had sustained a laceration on her finger while resisting care on August 7, 1996. The laceration was apparently quite serious, as Resident 10 was transferred to the emergency room as a result. HCFA Br., at 56-57 (citing Tr. 284-285; P. Ex. 74, at 10).

I also do not find persuasive the defenses that Petitioner's staff was familiar with Resident 10's needs because they were caring for her daily, and, therefore, she had received good care from staff not withstanding the defects in her assessments and care plan. The validity of these defenses is brought into doubt by other observations made by the Michigan State agency surveyors during the August 1996 survey. For example, just as the surveyors found evidence that Resident 10 was given interventions not specified in her written plan for the reduction of her resistance to care, they also found evidence that Petitioner's staff had failed to deliver to her all of the care specifically required in her care plan.

Under the related requirement for all facilities to have sufficient nursing staff to provide services in accordance with the individual plans of care, as set forth at 42 C.F.R. § 483.30(a), the August 1996 State agency survey team cited Petitioner for its failure to supervise Resident 10 constantly whenever she ate, as required by her plan of care.(25) The State agency surveyors saw in this resident's plan of care a directive for the staff to "STAY THERE" with her because she needed constant supervision. P. Ex. 77, at 1, 3. Yet a State agency surveyor observed Resident 10 eating lunch alone in her room without any supervision. Tr. 286-287. Upon further inquiry, the surveyor learned that only four nurse aides were working, whereas there were usually six working during the day shift. Tr. 287-288.

Additionally, a State agency surveyor heard from the wife of another resident (Resident 13) that Petitioner used many "agency help" who did not know the needs of the residents. Tr. 70. It is true, of course, that this statement by another resident's wife does not adequately establish the merits of HCFA's conclusion that inconsistent care to residents was caused by inadequate staffing and the changes in staff. See, HCFA Br., at 62; Pet. Br., at 60. Nor does the fact that Resident 10 was not provided the required supervision during lunch prove that there was no staff member available to do so. Many other situations described by HCFA showed that, even when the availability of staff members was not in dispute, the services received by residents were still inadequate or improper.

I note that, even disregarding the information gathered during the August survey concerning certain possible staffing problems, the evidence of record shows numerous inconsistencies between what Petitioner's staff was supposed to do for and pursuant to the residents' care plan, and what had in fact occurred. These inconsistencies and their potential adverse effects on the residents themselves cannot be excused merely because they may have been caused by some factor other than the staffing problems alleged by HCFA.

3. Resident 8 of the August 1996 Survey.

HCFA used information from Resident 8's records to prove Petitioner's failure to comply substantially with the following requirements:

-- 42 C.F.R. § 483.20(b)("Comprehensive assessments");

-- 42 C.F.R. § 483.25(d)(1)(ensuring against unnecessary catheterization);

-- 42 C.F.R. § 483.25(e)(2) (for a resident with limited range of motion, delivery of appropriate treatment and services to increase range of motion and/or to prevent further decrease in range of motion); and

-- 42 C.F.R. § 483.25(a)(3) (for a resident who is unable to carry out activities of daily living, delivery of necessary services for maintaining good nutrition, grooming, and personal and oral hygiene).

I find the evidence concerning Resident 8 to support HCFA's conclusions.

HCFA issued the citation under 42 C.F.R. § 483.25(a)(3) because a surveyor found a substance or coating in the mouth of several residents, including Resident 8. I will defer until later my discussion of the facts relating to Petitioner's failure to deliver proper grooming and hygiene to this and several other residents who were unable to carry out activities of daily living.

Like Resident 10 (discussed above), Resident 8 also did not receive a proper comprehensive assessment. Therefore, the surveyors found, among other things, that Petitioner had failed to comply with the following requirement of 42 C.F.R. § 483.25(d):

(d) Urinary Incontinence. Based on the resident's comprehensive assessment, the facilitymust ensure that-

(1) A resident who enters the facility without an indwelling catheter is not catheterized unless the resident's clinical condition demonstrates that catheterization was necessary . . . .

The defects in Resident 8's assessment and some of the resultant problems stemmed from the indwelling urinary catheter that was inserted on May 31, 1996, after Petitioner had completed a full assessment of this resident in March 1996 and while it was still performing this resident's quarterly assessment. On May 23, 1996, a week before the catheter was inserted, a LPN had completed a portion of the MDS for the quarterly assessment and indicated thereon that Resident 8 did not have a catheter at that time. Pet. Ex. 54, at 3. However, after the catheter was inserted, Petitioner's RN Assessment Coordinator certified the MDS has having been completed on June 5, 1996. Pet. Ex. 54, at 3. The RN Assessment Coordinator appears not to have checked on whether the previous entries remained current or were accurate. Therefore, the MDS certified on June 5, 1996 stated incorrectly that Resident 8 had no indwelling catheter. HCFA Ex. 41, at 7. A RAP for urinary catheter incontinence dated July 2, 1996 also stated incorrectly that this resident did not have a catheter. Tr. 260; Pet. Ex. 54, at 3.

At the time of the August 1996 survey, the Michigan State agency surveyors found no ongoing assessment of Resident 8's need for the catheter. Tr. 267. The surveyors could not determine from the documents maintained by Petitioner a clear reason for the placement of the catheter in the first place, nor any care plan provision concerning its removal. HCFA acknowledges that the records reviewed by the surveyors contained a diagnosis for urosepsis, as well as an order to insert a catheter. HCFA Br., at 37-38. However, the order did not specifically state that the catheter was needed to treat the resident's infection. Although the order, written as "Foley, I & O [input and output]" could be read to mean that the insertion of a Foley catheter was necessary to monitor Resident 8's urosepsis, HCFA correctly pointed out several problems with Petitioner's use of this possible interpretation as a defense.

First, the order could also be read to mean that a Foley catheter(26) was to be inserted (with no need having been identified) and then, in addition, the staff was to monitor the resident's urine input and output. Id. Reading the order as meaning that the catheter was needed to monitor the urosepsis would also appear to be at odds with the fact that Petitioner had left the catheter in place for a considerable period of time after Petitioner should have been aware that this resident's infection had cleared and her condition had stabilized, as indicated by the nurses' notes through June and July 1996, concerning the ongoing drainage of clear yellow urine. HCFA Br., at 38 (citing portions of Pet. Ex. 49). Yet, the catheter was not removed until August 27, 1996, after HCFA questioned why the catheter was needed. HCFA Ex. 71, at 37. Moreover, Petitioner, through the use of questions posed to a State agency surveyor at the hearing, raised the possibility that the catheter might have been needed for a permanent neurogenic bladder that resulted from this resident's cerebral vascular accident -- in which case, the catheter could not be removed. Tr. 279-280.

Even for the hearing, held long after Petitioner should have investigated and resolved the foregoing ambiguities, Petitioner did not present the explanations of the physician who had written the order for the catheter. Instead, Petitioner chose to call a member of its nursing staff and another physician to read and interpret the order of Resident 8's physician. As pointed out by Petitioner, the staff member testified that she believed Dr. Rhodes wanted the Foley catheter inserted "to monitor accurately this resident's intake and output." Pet. Br., at 53 (citing Tr. 762). (I do not know from the record, however, what "in-take" function a Foley catheter has, or what matters were supposed to be taken in by the Foley catheter for monitoring by Dr. Rhodes or Petitioner's staff.)

Dr. VanOosterhout, who was not Resident 8's physician,(27) testified that Dr. Rhodes' order could be read two different ways. See Pet. Br., 52 (citing Tr. 1041-1042). However, based on his familiarity with Resident 8 (who, as noted above, was not his patient), Dr. VanOosterhout thought that Dr. Rhodes' order should be interpreted to mean that Dr. Rhodes wanted the catheter inserted to obtain an accurate urine specimen and then left in for a period of time to ensure proper measurement of her urine output. Id., at 53-54. I do not accord the foregoing testimony by Dr. VanOosterhout the weight urged by Petitioner. Among other problems, Petitioner did not prove that those individuals delivering care to Resident 8 during the period in controversy had Dr. VanOosterhout's medical knowledge or his familiarity with Resident 8's clinical condition so that they would have known to interpret Dr. Rhodes' order as he had.

In any event, regardless of why the catheter was inserted, there was no assessment or care plan provision concerning when or under what circumstances the catheter should be removed. Dr. VanOosterhout's hearing testimony was, for example, that he thought Dr. Rhodes wanted the catheter left in "for a period of time" to make sure the resident was not retaining fluid. Tr. 1030. The regulation at 42 C.F.R. § 483.25(d)(1) contains the administrative notice of the risks created by the unnecessary use of indwelling catheters.

The nature of such risks has also been described above, in my summary of the relevant testimonial evidence concerning Resident 10. Here, suffice it to note that the regulation at 42 C.F.R. § 483.25(d)(1) clearly required Petitioner to use the content of each resident's comprehensive assessment as a basis for ensuring against the unnecessary insertion of any indwelling catheter. Therefore, this regulation can hardly be interpreted as meaning that, once the catheter has been inserted for a reason that has not been stated clearly in any contemporaneously generated comprehensive assessment or resident care plan, Petitioner may then allow its staff to keep the indwelling catheter in place without providing any written limitations in the resident's care plan for protecting the resident against unknowledgeable, careless, or unconcerned care-givers. Moreover, nothing in this regulation may be reasonably interpreted as meaning that individual staff members should read the various available diagnoses in order to determine, if they wished to do so, why insertion of the catheter had been necessary in the first instance, what condition was being addressed by the catheter, and when or whether its removal would be appropriate. In fact, nothing of record establishes that Petitioner has charged anyone on its staff with making such determinations.

Inaccuracies in Resident 8's assessments appear to have led also to Petitioner's failure to comply substantially with 42 C.F.R. § 483.25(e)(2), which required the delivery of treatment and services to increase the resident's range of motion or to prevent further decrease thereof. Again, such treatment and services were supposed to have been provided on the basis of the resident's comprehensive assessment. 42 C.F.R. § 483.25(e).

The August 1996 Michigan State agency survey team found that Petitioner knew that Resident 8 had contractures and was supposed to provide her with range of motion services. The surveyors found documents dated between July 25, 1995 and March 1996 showing a decrease in this resident's joint motion mobility. Tr. 261-63; Pet. Ex. 57, at 1-2. For example, her shoulder flexion decreased 10 degrees to the left and five degrees to the right; the internal and external rotation of her left shoulder decreased by 35 degrees each; the external rotation of her right shoulder had decreased 10 degrees; her left hip declined 10 degrees in abduction and internal rotation; and the external rotation of her hip declined 25 degrees on the left and 15 degrees on the right. Id. However, notwithstanding these notations of decreases, Petitioner documented, on March 13, 1996, that Resident 8's range of motion had been assessed and that no change had been noticed. Pet. Ex. 50, at 2. As a consequence of the foregoing assessment information dated March 13, 1996, which HCFA alleges to be inaccurate, Petitioner also decreased the range of motion exercises for Resident 8 from five times a week to only three times a week. Id. By the time of the August 1996 survey, Petitioner's staff had reduced the full range of motion exercise to only flexion and extension of joints for this resident. Tr. 263-264.(28) On these facts, HCFA concluded that Petitioner's failure to assess Resident 8's range of motion declines accurately under 42 C.F.R. § 498.20(b) resulted in its provision of inadequate or inappropriate range of motion services under 42 C.F.R. § 498.25(e)(2), and thereby created the potential for this resident to suffer range of motion losses that would been more than minimal.

Petitioner introduced testimony of its therapist to suggest that its March 13, 1996 assessment conclusion was not incorrect. According to the opinion of Petitioner's therapist, the earlier measurements of decreases relied upon by HCFA reflected only minor fluctuations, which she attributed to Resident 8's resistance to the range of motion services. Tr. 784. Petitioner identified the parts of its records which show that the measurements of the resident's decreases prior to March 1996 were placed with remarks that "patient stiffens up with attempts at PROM . . . .," and "Patient somewhat resistant to PROM to full extent. Measurements may not be consistent due to this." Pet. Br., at 55 (citing Pet. Ex. 57, at 2). Petitioner also pointed to testimony that contracture measurements are not always consistent, and that different people performing the measurements could attain different results. Id., at 56.

Additionally, Petitioner represented that the March 13, 1996 MDS indicated that there was no functional range of motion change from the previous MDS performed in January, 1996. Pet. Br., at 56. Petitioner's therapist explained that no functional range of motion change meant that the resident was still able to raise her arm to touch the back of her head and shoulder to the same extent as before, and she was still able to bring her hips and knees to 90 degrees. Id., n.82. Petitioner emphasized the portion of the therapist's testimony in which she expressed her opinion that the regulations did not require that exact joint measurements be taken during the assessment process, and only the functional ranges needed to be assessed for completion of the MDS. Id., at 55 n.80.

I find that Petitioner's evidence and arguments do not materially affect the validity of HCFA's conclusions that Petitioner's services for Resident 8's range of motion limitations fell short of what was required by 42 C.F.R. § 483.25(e)(2), and created a potential for more than minimal harm to this resident; and, therefore, those services were out of substantial compliance with the regulatory requirements. Obviously, the language of 42 C.F.R. § 483.25(e)(2) does not state that Petitioner's obligation to its resident was limited to maintaining her functional range of motion. The regulation uses the words "to increase range of motion and/or to prevent further decrease in range of motion." 42 C.F.R. § 483.25(e)(2). While it may be true that Petitioner was referring to Resident 8's functional range on the March 13, 1996 MDS form, Petitioner was not relieved of the duty to comply with all requirements of 42 C.F.R. § 483.25(e)(2), because there had been no change to her functional range since the prior assessment.

The credibility of Petitioner's contention that only Resident 8's functional range was of concern to it is also undercut by the fact that its own staff had taken the above-stated measurements in addition, and its staff made a record of those measurements. It is true that the staff recorded the measurements of apparent decreases with accompanying caveats, such as the need to consider Resident 8's resistence to treatment and pain as a factor. However, the staff's actions and remarks do not reasonably suggest that the measurements were without any significance whatsoever and that, therefore, recording them was a meaningless exercise. Instead, the staff's actions and words give rise to the reasonable inference that the measurements meant something -- especially since this resident was already receiving treatment for her range of motion limitations -- but the staff members recording those measurements could not determine the true extent of their significance in terms of any actual losses.

Even if Petitioner believed that the recorded measurements did not indicate the true state of this resident's range of motion limitations between the two formal assessments, that belief would not excuse Petitioner from evaluating whether Resident 8 had, in fact, suffered any actual decreases in her already limited range of motion, how her range of motion might be measured with greater accuracy or consistency, the reasons why she might (or might not) be experiencing actual decreases, why she was resisting the range of motion treatments, and whether her resistance might be alleviated to promote increases (and prevent further decreases) in her range of motion. The staff's remarks concerning the questionable accuracy of the measurements they recorded should have alerted Petitioner to conduct comprehensive assessments along those lines so that it could deliver to Resident 8 those services appropriate to satisfying the requirements of 42 C.F.R. § 483.25(e)(2). Instead, Petitioner opted to rely on the simple fact that the measurements taken by its staff (as Petitioner chose to leave them) were of questionable accuracy and undetermined significance. Nor do I find persuasive Petitioner's contention that there was no means for obtaining accurate and consistent measurements of the resident's true limitations because different people taking the measurements may cause variations in the recorded results. There is nothing in the record to indicate that Petitioner had assigned the measuring task to the same individual in an effort to maintain consistency and obtain less questionable results for Resident 8.

As HCFA noted in response to Petitioner's arguments, the Michigan State agency surveyor recognized that the recorded measurements may have been inaccurate; therefore, neither she nor HCFA contends that Petitioner's omissions had caused any actual harm to Resident 8. HCFA Rep. Br., at 32. Rather, HCFA contends only that Petitioner's omission caused a potential for more than minimal harm. Id.(citing Tr. 312). I find this conclusion to be reasonable and adequately supported by the available evidence.

I observed in an earlier part of this Decision that, in many cases, actual declines in residents suffering from degenerative conditions will become noticeable only if the facility maintains accurate and complete records over time. Here, because Petitioner chose not to investigate and resolve the range of motion questions raised by its own records, it did not generate the facts necessary for resolving the question of whether Resident 8 had sustained any actual range of motion losses by the time of the August 1996 survey. Therefore, it is not possible to reach the question of whether Petitioner's omissions caused actual harm to this resident. However, it is apparent from applying the potential for more than minimal harm standard that Petitioner's omissions constituted noncompliance, because those omissions placed Resident 8 at risk for having any real losses in her range of motion go unnoticed and untreated under Petitioner's asserted practice of assessing for only functional changes and interpreting ambiguous measurements of possible decreases as meaning that the resident has been maintaining the status quo.

4. Resident 16 of August 1996 Survey.

HCFA used information from Resident 16's records to prove Petitioner's failure to comply substantially with the following requirements:

-- 42 C.F.R. § 483.20(b)("Comprehensive assessments");

-- 42 C.F.R. § 483.20(d)("Comprehensive care plans"); and

-- 42 C.F.R. § 483.25(c)(delivery of services to prevent and treat pressure sores).

The evidence concerning Resident 16 supports HCFA's conclusions.

Petitioner failed to complete a comprehensive assessment within 14 days of Resident 16's admission, as required by 42 C.F.R. § 483.20(b)(4)(i). Even without considering the issue of whether the content of the assessment documents showed a comprehensive evaluation of Resident 16's needs, the August 1996 survey team noted that the assessments were not completed until August 6, 1996, more than two months after her admission on May 16, 1996. Additionally, the survey team found that even as of August 6, 1996, that the assessments done for Resident 16 were neither comprehensive nor fully accurate. See HCFA Ex. 49, at 5-10.

As specifically pointed out by HCFA, the MDS Petitioner had belatedly completed for Resident 16, over two months after her admission, showed on one particular line of that form that she had one pressure ulcer. See Pet. Ex. 126, at 6, Line M2. Therefore, unlike the situation of Resident 2 discussed above (where Petitioner argued that no pressure sore RAP was triggered for Resident 2 because there was no entry of a pressure sore on the MDS), Petitioner should have been aware that its notation of a pressure sore at Line M2 of the MDS for Resident 16 should have triggered a pressure sore RAP assessment for her. Moreover, the RAP Trigger Legend provides that an entry on that line should cause the creation of a Pressure Ulcer RAP. See HCFA Ex. 27, at 43. However, no pressure ulcer RAP was done for Resident 16 by Petitioner. HCFA Br., at 49 (citing Pet. Ex. 126, at 8).

Additionally, as in the assessments done for Resident 2, Petitioner had recorded inconsistent information (without having resolved it) for Resident 16. Citing Petitioner's Exhibit 126, at 6, HCFA noted that the absence of any pressure ulcer was also indicated on another line of the MDS Petitioner had completed for Resident 16. Id., at 6, Line M1. The two lines containing contradictory information about the presence and absence of a pressure sore appear one on top of the other on the MDS form. Id., at 6, Lines M1, M2.

Petitioner attributed the inconsistencies in the MDS to the mistake of a former employee. HCFA Ex. 71, at 34. According to Petitioner, Resident 16 never had any pressure sores when the assessment forms were being filled out. Id. However, other information also maintained by Petitioner when it was performing Resident 16's assessments further supports HCFA's conclusion that a RAP for skin sores or potential skin breakdowns should have been done. For example, progress notes dated May 17, 1996, described skin breakdown and healing on her heel, while nursing notes described a blackened area on the resident's left heel and indicated that her right heel was dry and cracked. Pet. Ex. 123, at 2; Pet. Ex. 124, at 1. One of Petitioner's witnesses indicated at hearing that this resident had a blackened area, or eschar, on her left heel. Tr. 734. Given Petitioner's obligation to prevent the development of pressure sores with use of the comprehensive assessments (42 C.F.R. § 483.25(c)), I do not think that any pressure ulcer needs to have manifested itself during the assessment process, as suggested by Petitioner's arguments. Moreover, as in the case of Resident 2, Petitioner appears to be splitting hairs over technical definitions of pressure sores. The validity of HCFA's noncompliance citations has not been materially affected by Petitioner's contention that its staff did not observe the actual presence of a condition they would classify as a true pressure sore, as opposed to an eschar or other forms of skin breakdown, on Resident 16 during the assessment process. Whatever the cause, no RAP assessment for pressure sores was ever done for Resident 16. Nor did Petitioner develop any care plan for pressure sores. While awaiting completion of her assessment and a care plan, Resident 16 developed a pressure sore on her right heel. Tr. 99; HCFA Ex. 49, at 3.

Petitioner did not specifically refute any of the foregoing evidence prevented by HCFA. Instead, it argued that (1) the surveyor testified that Resident 16 was given care for the pressure sore on her right heel (and the sore was healing), thereby proving that defects in the resident assessments and care plan were mere technical failings lacking any potential for harming this resident; and (2) HCFA did not introduce sufficient proof that the heel ulcer developed after the resident's admission, as opposed to before her admission. Pet. Rep. Br., at 43.

These responses do not address Petitioner's failure to prevent the development of pressure sores with use of the comprehensive assessments and an appropriately prepared care plan. Petitioner's arguments reflect a "band-aid" approach that is not consistent with the regulations. The facts underlying Petitioner's defenses for Resident 16 are that it had taken over two months to do assessments that were neither fully accurate nor comprehensive, and it prepared an inadequate plan of care, which Petitioner alleges it informally supplemented (i.e., without input from the appropriate interdisciplinary team or setting forth objective goals and schedules) by simply delivering services that were not provided for by the assessments or the care plan. These responses again show Petitioner's disregard for the function of comprehensive assessments and their relationship to the formulation of a care plan. As in other instances, members of Petitioner's staff created what they considered to be care plans or delivered services of questionable benefit to residents without having completed a comprehensive written assessment of the residents' needs. See, e.g., defenses of omissions in Resident 9's assessment records in Pet. Rep. Br., at 38-39.

5. Resident 13 of August 1996 Survey.

HCFA used Resident 13 as an example to prove that Petitioner was out of substantial compliance with the following requirements:

-- 42 C.F.R. § 483.20(b)("Comprehensive assessments");

-- 42 C.F.R. § 483.25(c) (delivery of necessary services to prevent and treat pressure sores);

-- 42 C.F.R. § 483.25(a)(3) (for a resident who is unable to carry out activities of daily living, delivery of necessary services for maintaining good nutrition, grooming, and personal and oral hygiene); and

-- 42 C.F.R. § 483.25(e)(2) (for a resident with limited range of motion, delivery of appropriate treatment and services to increase range of motion and/or to prevent further decrease in range of motion).

The evidence concerning Resident 13 supports HCFA's conclusions.

The annual assessment done by Petitioner for Resident 13 showed significant timeliness problems. Under 42 C.F.R. § 483.20(b)(4)(v), each resident is entitled to a written comprehensive assessment "[i]n no case less often than once every 12 months." The August 1996 survey team found that, even though Petitioner had begun the annual assessment process on June 3, 1996, the assessments had not been completed in the intervening period of more than two months. Pet. Ex. 98; Tr. 63.

When the surveyors made observations of the personal and oral hygiene of those residents who were assessed by Petitioner to be unable to carry out the activities of daily living, the surveyors found that Resident 13 and other dependent residents had a whitish material coating their tongues, indicative of poor or inadequate oral care. For other dependent residents, the surveyors witnessed the delivery of poor grooming care and related problems. HCFA attributed significance to Resident 13's situation for several reasons.

Resident 13 was on tube feeding (i.e., he took nothing by mouth), and he was totally dependent on the staff for his care. The testimony introduced by both parties show that residents on tubes are prone to developing build-ups on their tongue, since they tend to breath through their mouths and cannot properly swallow. The Dental Care RAP for Resident 13 appears to recognize these facts, for it states that he needed "frequent mouth care to prevent the mouth from crusting." Pet. Ex. 85, at 1. At the hearing, however, Petitioner attempted to interpret "frequent" as meaning whenever its staff sees a need to provide the care. Tr. 850. Obviously, the problem with this interpretation of "frequent" is that Resident 13 would not receive any needed oral care if the care giver failed or refused to inspect the condition of his mouth. This appears to be a reasonable inference arising from the surveyor's observation that Resident 13 had a white coating on his tongue.

Additionally, notwithstanding how the word "frequent" should be interpreted, Petitioner's staff failed to follow the specific provision of the plan of care. The care plan Petitioner prepared for Resident 13 required "good oral hygiene" every shift. HCFA Ex. 46, at 12. However, when the State agency surveyor made her observation of the morning care provided by Petitioner's staff at 10:30 A.M. on August 8, 1996, Resident 13 was not given any oral care even though his tongue was coated with a whitish material and his lips were dry. Tr. 67. The surveyor testified that, in her opinion and based on her experience, proper oral care provided every shift would not have resulted in the coating of the resident's tongue or dryness of his lips. Tr. 64, 134.

The evidence shows also that removal of the whitish coating from the resident's tongue could have been done easily, and its recurrence could have prevented just as easily as a matter of routine. When the surveyor brought the coating to Petitioner's attention, the coating was easily removed with use of a sponge or similar device, according to the surveyor's observations. Petitioner does not contend that the resident's care plan or assessment RAP called for more extraordinary measures. Therefore, I agree with HCFA that the condition of Resident 13's tongue is part of a pattern of noncompliance with the resident grooming and hygiene requirements.(29)

HCFA also used Resident 13 as an example of Petitioner's failure to comply substantially with its obligation to prevent and treat the recurrence of pressure sores. This resident was admitted by Petitioner with a Stage II pressure sore on his coccyx. The pressure sore on his coccyx healed while he was placed on a flexicare bed; use of the flexicare bed was discontinued on May 31, 1996. However, Resident 13 developed a new pressure sore within one week after the discontinuation of the flexicare bed. Pet. Ex. 85, at 4. By the time of the August 1996 survey, Resident 13 had a Stage III sore on his right lateral leg and heel, and a Stage II pressure sore on his coccyx. Id.

Petitioner argued that discontinuing the flexicare bed for Resident 13 was "neither unreasonable nor inappropriate." Pet. Br., at 36. It emphasized the testimony of its witnesses which establish that, when Resident 13 was given the flexicare bed, the Medicare program was paying Petitioner for providing this specialty bed as treatment for this resident's pressure sore. Id. After the sore on his coccyx healed, Resident 13 was decertified for Medicare payments and taken off the flexicare bed. Id. According to Petitioner, Resident 13 was not on either Medicare or Medicaid benefits when he developed a new pressure sore during the time in issue; he was supposed to have been "strictly self-pay", but Petitioner was not receiving any payments from him and was on the verge of applying for his guardianship as redress. Id. Petitioner emphasized also its witness' testimony that, in order for the facility to receive Medicaid payments for providing a specialty bed, the resident's pressure sore must be at Stage III or Stage IV, or the resident must have multiple Stage II sores. Id., at 36-37. In this case, Resident 13 had developed only one pressure sore on his coccyx one week after the flexicare bed was discontinued, and that sore had progressed to only Stage II by the time of the August survey.

Whatever the legal merits of Petitioner's justifications for having failed to provide the flexicare bed after May 31, 1996, the defense is non-responsive to HCFA's position. HCFA's position is not that any particular service, or any particular set of services, would have provided Resident 13 with 100% protection against the recurrence of pressure sores. Rather, HCFA's position is that Petitioner failed to effectuate certain reasonable precautions against their recurrence (some of which precautions were specifically required by Resident 13's care plan), even though Petitioner knew from this resident's condition on admission (a Stage II ulcer on his coccyx) that he was susceptible to experiencing skin breakdowns. Additionally, Petitioner should have known also that the healing of that Stage II ulcer on his coccyx before May 31, 1996 was not adequate prevention against its recurrence. HCFA did not allege specifically that discontinuation of the flexicare bed was improper. HCFA noted that the special bed was only one "potent weapon" in the treatment and prevention of pressure sores. HCFA Br., at 20. However, HCFA emphasized that, whether or not the flexicare bed was used, appropriate nursing interventions are essential in preventing or retarding the development of new sores. Id. (citing testimony from Petitioner's witness). HCFA then gave examples of the nursing staff's failure to deliver appropriate and required services to Resident 13.

Even though Petitioner's care plan for Resident 13 specified that he was to be turned every two hours, a surveyor saw that he was not turned every two hours on either August 7, 1996 or August 8, 1996. HCFA Ex. 46, at 14; P. Ex. 90, at 5; HCFA Ex. 46, at 4. The surveyor also observed very deep wrinkles on this resident's back, which indicated that he had lain in the same position for a very long time. Tr. 58. There appears to be no dispute that the care plan's requirement for turning Resident 13 every two hours was intended to help prevent and heal pressure sores, or that keeping Resident 13 in the same position for extended periods may contribute to development of those sores as well as retard the healing of any skin breakdowns. Petitioner has not made a credible showing that, on all other days when the Michigan State agency surveyor was not observing Resident 13, its nurse aides were in fact turning this resident every two hours in accordance with the care plan. See Pet. Ex. 94.

The Michigan State agency surveyor observed also that a nurse aide was pushing and pulling an incontinent pad under Resident 13 on the morning of August 8, 1996. Tr. 56. The State agency surveyor thought that friction and shearing had been caused by the aide's actions. Id. When asked why she did not get someone to help her move Resident 13 instead of pulling on the incontinent pad by herself, the aide to the State agency surveyor that it was difficult to find anyone to help her. Tr. 59; HCFA Ex. 46, at 4. The nurse aide's statement gives rise to the reasonable and unrebutted(30) inference that what the State agency surveyor observed on August 8, 1996 was not a one-time occurrence. By use of the surveyor's testimony and information contained in a HHS publication on the treatment of pressure sores, HCFA established that the irritation, friction or shearing forces likely caused by the nurse aide's actions could contribute to skin breakdowns.

Additionally, the portion of Resident 13's care plan pertaining to his range of motion stated that a splint should be worn to promote skin integrity on his hand. HCFA Ex. 46, at 8. No such splint was seen on Resident 13 during the survey. Id. HCFA used this as an another example of Petitioner's failure to deliver those services it knew to be necessary and appropriate under 42 C.F.R. § 483.25(c). HCFA Br., at 22.

HCFA further proved that Petitioner's efforts to address Resident 13's range of motion problems were not in substantial compliance with the requirements of 42 C.F.R. § 483.25(e)(2). This resident had loss of motion on both sides of his body. However, whereas a comprehensive care plan must include "measurable objectives and timetables to meet the resident's . . . needs that are identified in the comprehensive assessment", the care plan Petitioner prepared for Resident 13 stated the vague goal of maintaining his current range of motion "per quarterly review" for all extremities. 42 C.F.R. § 483.20(d); HCFA Ex. 46, at 8. However, the Michigan State agency surveyors found in August 1996 that no measurements had been taken for Resident 13 since February 26, 1996. Since Petitioner had done no quarterly review, it was not effectuating its vague goal of maintaining current range of motion "per quarterly review" for Resident 13.(31) The surveyor learned from the manager of the physical therapy department that he was performing only annual measurements. Tr. 60-61; HCFA Ex. 46, at 7.

Petitioner noted that the federal regulations do not state that quarterly assessments must be made of any resident's range of motion. Pet. Br., at 57. In Petitioner's view, the Michigan State agency surveyor had created a requirement for Petitioner to conduct such quarterly assessments. See id., at 57-58. I note, however, that Petitioner had the following obligation:

Review of assessments. The nursing facility must examine each resident no less than once every 3 months, and as appropriate, revise the resident's assessment to assure the continued accuracy of the assessment.

42 C.F.R. § 483.20(b)(5). Since quarterly examinations and revisions, if any, to the assessment, are supposed to address the individual needs of each resident, it cannot be concluded logically that Petitioner was without a duty to measure Resident 13's range of motion every quarter because the regulation did not specifically mandate that every resident's range of motion must be measured and evaluated every quarter.

In addition, HCFA's citation against Petitioner is based on the fact that Petitioner itself stated in the care plan it prepared for Resident 13 that his current range of motion should be maintained "per quarterly assessments." Given that a care plan must describe the "services that are to be furnished to attain or maintain the resident's highest practicable . . . well-being as required under § 483.25" (42 C.F.R. § 483.20(d)(i)), Petitioner's voluntary inclusion of quarterly range of motion reviews in Resident 13's care plan constituted an admission that it believed conducting such reviews would be necessary and appropriate for this resident's care or treatment. Petitioner has not provided any credible explanation of how, without taking range of motion measurements every quarter, it could determine whether Resident 13's range of motion had been maintained "per quarterly assessments." In this context, the absence of any federal requirement to take quarterly measurements (or conduct quarterly assessments) of every resident's range of motion is immaterial. Petitioner's failure to provide all the services it had included in Resident 13's care plan is consistent with the pattern of arbitrary or illogical events shown by the evidence.

Petitioner's failure to deliver services in accordance with Resident 13's care plan was not limited to the failure to make quarterly assessments of his range of motion. Petitioner's staff also failed to satisfy the portion of Resident 13's care plan which specified that he was to receive 7 to 10 "reps" to all four extremities every day, in order to maintain his current range of motion for the four extremities. The Michigan State agency surveyor saw the delivery of other range of motion exercises to Resident 13, but not the 7 to 10 "reps" required for all four extremities. Tr. 60; 241-42.

As noted earlier, Resident 13 should have worn a hand splint in accordance with his care plan. The goal stated in his care plan for his right wrist and fingers was to maintain his current range of motion as well as to promote skin integrity of the hand. The plan provided for a splint to be worn on his right hand 24 hours a day, except when he received A.M. and P.M. care, and he to be given range of motion exercises. However, no hand splint was seen on this resident during the survey. HCFA Br., at 22, 36; HCFA Ex. 46, at 8.

6. Resident 14 of the August 1996 Survey.

Significant deviation from the timeliness requirement was also found by the surveyors in their review of the assessments for Resident 14. According to Petitioner's records, Resident 14 was admitted on June 13, 1996, and he was totally dependent on the facility's staff for his care. Pet. Ex. 101, at 1. The parties are in apparent agreement that Petitioner needed to assess this resident for his activities of daily living, delirium, communication, pressure sores, and dehydration. However, Petitioner did not complete a comprehensive assessment of Resident 14 until August 5, 1996, well after the deadline of 14 days post-admission.

B. Discussion of FFCL No. 2.

There is not sufficient credible and reliable evidence supporting HCFA's conclusion from the August, 1996 survey that Petitioner lacked sufficient nursing staff to provide services in accordance with the individual plans of care, as required by 42 C.F.R. § 483.30(a).

HCFA drew its conclusion from a Michigan State agency surveyor's observation that no staff member supervised Resident 10 when she ate her lunch one day, even though her care plan stated she needed constant supervision. Pet. Ex. 77, at 1, 3; Tr. 286-287. The conclusion was also based on the same surveyor's observation that, by late morning one day, Resident 10 and certain other residents had not been dressed or taken out of bed by staff. See HCFA Br., at 61. Prompted by these observations, the State agency surveyors make inquiries and found out that only four nurse aides were working, whereas there were usually six nurse aides working during the day shift. Tr. 287-288. Additionally, the State agency surveyor heard from the wife of another resident (Resident 13) that Petitioner used many "agency help" and that the people sent by agencies did not know the needs of Petitioner's residents. Tr. 70.

As I discussed previously, the concept of substantial compliance tolerates some degree of imperfection. In this case, HCFA has given too much significance to the number of nurse aides working on one shift of one specific day. As acknowledged by HCFA, the Michigan State agency surveyor only asked about the number of nurse aides working the day shift on the day she observed various residents, including Resident 10, still in bed and not dressed by late morning. HCFA Br., at 61. The perceptions of a resident's wife as reported to a surveyor, even if assumed reliable, does not suffice for proving Petitioner's noncompliance with staffing requirements when the surveyors did not ask for a review of Petitioner's staffing records over time. Moreover, given the unique facts of this case, the Michigan State agency surveyor's observation that Resident 10 was eating unsupervised on a day when two of six nurse aides were absent does not provide sufficient support for the inadequate staffing citation. In order to reach the conclusion that the lack of supervision to Resident 10 was caused by inadequate staffing, I would have to assume that, if all six aides were present, Resident 10 would have received the supervision specified in his care plan. This assumption cannot be made on the basis of the present record.

HCFA has proven Petitioner's noncompliance with other requirements with examples of staff actions which seemed illogical or were at variance with the residents' care plans even when no staff member was alleged to have been absent. Several times, surveyors saw care-givers delivering services improperly or incompletely. Under these circumstances, it cannot be concluded reasonably that, more likely than not, the failure to supervise Resident 10 during lunch was due to the absence of two nurse aides on that day, as opposed to, for example, the staff's lack of familiarity with the resident's care plan, the staff's lack of concern for what is written in the care plan, or the staff's failure to understand the proper relationship between the care plan and the services delivered to residents. The latter conclusions are better supported by the record as a whole, and they have been included in my affirmation of those August 1996 noncompliance findings issued by HCFA under the regulations governing assessments, care plans, and the various quality of care requirements.

C. Discussion of FFCL No. 5.

For the October 1996 revisit survey, HCFA has proved Petitioner's noncompliance with 42 C.F.R. § 483.75(e)(8), which states:

(e) Required training of nursing aides --

. . . .

(8) Regular in-service education. The facility must complete a performance review of every nurse aide at least once every 12 months, and must provide regular in-service education based on the outcome of these reviews. The in-service training must -

(i) Be sufficient to ensure the continuing competence of nurse aides, but must be no less than 12 hours per year . . . .

It is undisputed that Petitioner used nurse aides provided by three agencies during the relevant time period. Over 20% of its aides were sent by the agencies. Tr. 1101-1102. Petitioner's educators did not provide training to these agency aides; rather, it entered into contracts which made the agencies responsible for providing training to these aides. Tr. 680, 1099. For these reasons, HCFA placed into the record the information obtained from the three agencies in support of its conclusion that Petitioner had failed to meet its obligations under 42 C.F.R. § 483.75(e)(8).

The Alpha Christian Registry provided no training records for any of the nurse aides used by Petitioner. Instead, during the October 1996 resurvey, the Registry faxed a note stating that all those who were "falling behind" in their in-service hours would have the required hours prior to December 31, 1996. HCFA Ex. 66, at 4. This information indicates that, in the agency's view, certain nurse aides were not current on the training requirements. However, the Registry did not define the term "falling behind." Nor did the agency identify those aides in this category who worked at Petitioner's facility.

As also noted by HCFA, the problem is that using December 31, 1996 as the "catching-up" deadline would satisfy the "12 hours per year" requirement only for those nurse aides who commenced work on January 1, 1996 or later. HCFA Br., at 81-82. HCFA was concerned that, included in the unidentified group of nurse aides who were "falling behind in their in-service hours," according to the Registry's letter transmitted by facsimile dated October 17, 1996, may have been nurse aides who were hired more than 12 months ago. For those aides hired before January 1, 1996, having them complete the 12 hours of training by December 31, 1996 would still mean that they had gone longer than one year without having completed the required hours. Id.

The Worth Agency supplied records for 10 aides who worked regularly for Petitioner. HCFA acknowledged that two of the 10 clearly met the training requirement. HCFA set forth its concerns for the accuracy of the information supplied for three of the aides who appeared to have met the requirements, and HCFA pointed out that the remaining five nurse aides sent by the Worth Agency did not meet the training requirements. HCFA Br., at 82.

As for the remaining five nurse aides sent by the Worth Agency, their training fell far short of the regulatory requirement. One nurse aide, hired on August 10, 1995, had received no training in the 14 months since her hire. HCFA Ex. 66, at 6. Two other nurse aides had received one hour of training on the date of their hire during 1996, but they had received no training since then. HCFA Ex. 66, at 9-10. Another nurse aide hired in 1996 had less than one-half of her required training hours; an additional nurse aide had completed two-thirds of her required hours. HCFA Ex. 66, at 18-19. To address the possibility that the last two nurse aides might still have had time to take their remaining hours, HCFA noted that the Worth Agency had given all its aides a deadline (90 days after July 19, 1996) to complete the 12 hours. HCFA Ex. 66, at 11. None of the above-mentioned five nurse aides had completed those hours by the deadline.

Petitioner has introduced no fact showing that all the contract nurse aides it used had the in-service hours required by 42 C.F.R. § 483.75(e)(8). Petitioner provided nothing to show that the training information provided by the three agencies were in error, or that it had provided additional training to the nurse aides during the relevant time period. Nor did Petitioner establish the existence of any procedure it was using prior to the October revisit survey to determine what training was received by the nurse aides sent from those agencies. Instead, in its briefs, Petitioner asserted that I had already found noncompliance on this issue during the hearing.(32)

While not denying that the problems noted by HCFA constitute deficiencies under the training regulation, Petitioner contends that it was in substantial compliance because no resident was at risk for more than minimal harm. Petitioner argued also that the Michigan State agency surveyors have made the deficiencies appear more serious than they were in reality with use of inflammatory tactics. Specifically, Petitioner complained that a State agency surveyor had given the incorrect information that all of the nurse aides at the facility were provided by staffing agencies, and, moreover, the State agency surveyors had deviated from guidelines when they wrote into their report the opinion that the training records for three of the Worth Agency's aides looked suspicious. Pet. Br., at 79; Pet. Rep. Br., at 63.

I find unpersuasive the arguments used by Petitioner. In its Post-Hearing Brief, HCFA acknowledged that the Michigan State agency surveyor was wrong in having initially asserted that Petitioner used only nurse aides provided by staffing agencies. HCFA Br., at 81. In addition, whether some of the training information provided by the Worth Agency looked suspicious or not to the surveyors is immaterial. According to the information provided by the Worth Agency, one nurse aide completed all 12 hours of in-service training on "8/96." HCFA Ex. 66, at 8. Although HCFA found this information troubling due to the absence of any actual training date, it did not allege that this aide was without the required training. HCFA noted also that two other nurse aides were said to have completed 11 of their required hours on a single day during the October resurvey. See HCFA Br., at 82. However, HCFA did not contend that these two aides' training was deficient. Petitioner has provided no fact or argument to controvert HCFA's findings that five other nurse aides provided by the Worth Agency lacked the required in-service hours.

Petitioner has also provided no fact or argument to controvert HCFA's showing that the information provided by the Alpha Christian Registry is insufficient for establishing that the nurse aides it provided to Petitioner had undergone the required training hours timely.

On the issue of whether there was a resultant risk of more than minimal harm to residents, I find in favor of HCFA. Under 42 C.F.R. § 483.75(e)(8), the more than minimal risk of harm to patients stemmed from the fact that Petitioner had no effective practice or procedures in place at the time of the revisit survey to ensure that the aides sent by a staffing agency were current on the requisite in-service requirements. While there appear to have been agreements made between the staffing agencies and Petitioner, and at least one such agency had a written requirement for all of its nurse aides to complete their 12 hours within 90 days of hire(33), the examples cited by HCFA establish that the agreements and written commitments were not always kept. Petitioner did not identify and correct these lapses on its own. If the Michigan State agency surveyors had not investigated the training of the staffing agency aides, it is unlikely that Petitioner could not have done so.

It is true that the Michigan State agency surveyors were able to cull out only a handful of nurse aides who were clearly without adequate training from the information provided by one staffing agency. (The other staffing agency only indicated generally that some aides were "falling behind" on their requirements.) However, had the State agency surveyor not intervened during October 1996, Petitioner likely would have put to work even more under-trained contract nurse aides, or contract nurse aides who have not met the training requirements for even longer periods, because it was not questioning the qualifications of those sent by the staffing agencies. Thus, there existed the potential for more than minimal harm to residents because Petitioner failed to monitor and ensure that only nurse aides who satisfied the training requirements of 42 C.F.R. §483.75(e)(8) were delivering care to them.

D. Discussion of FFCL Nos. 4 and 6.

1. Resident 7 of the October 1996 Revisit Survey.

HCFA used Resident 7 of the second survey as an example of Petitioner's failure to comply substantially with the assessment regulation, as well as the portion of the quality of care regulation which required Petitioner to provide, in accordance with the resident's comprehensive assessments and care plan, the supervision and assistive devices that are adequate to prevent accidents. 42 C.F.R. §§ 483.20(b); 483.25(h)(2). I find that HCFA's conclusions are supported by a preponderance of the evidence concerning Resident 7.

Resident 7 of the October 1996 revisit survey was the same individual who was designated as Resident 1 in the initial, August 1996 survey.(34) This resident had Parkinson's disease and balance problems, and, during the August survey, he was observed in a wheelchair with a lap tray in place. The August State agency survey team questioned why the lap tray was in use, whether it was intended to (or was in fact) serving as a restraint device, and whether the lap tray was effectively serving whatever purpose may have been intended. Because unambiguous answers to these questions could not be found in the resident's assessment records, HCFA used the questions concerning this resident's lap tray to support the finding that Petitioner was out of substantial compliance with 42 C.F.R. § 483.20(b), which required that the resident's assessments be comprehensive and accurate. Neither HCFA nor the surveyors ordered Petitioner to remove this resident's lap tray. However, it was expected that Petitioner would respond to the assessment citation of August 1996 by properly assessing this resident's needs by considering questions such as whether the resident needed a restraint, whether use of the lap tray should be continued for that or another purpose. See, Tr. 798-790.

HCFA acknowledges that Petitioner performed a "physical restraint elimination assessment" on September 4, 1996, which stated that this resident had normal sitting balance. HCFA Br., at 69. However, a few days later, the same resident (designated Resident 7 for the revisit survey) began to sustain a series of falls. HCFA pointed out that, on September 9, 1996, Resident 7 was found on the floor. HCFA Ex. 61, at 31-32. He was again found on the floor on September 28, 1996, this time face down, with his wheelchair on top of him. Tr. 452. The fall on September 28, 1996 caused him to be sent to the emergency room, for the stitching of a cut on his forehead and for a skin tear on his right hand. HCFA Ex. 61, at 14, 33-34.

Subsequently, on October 5, 1996, Resident 7 fell two more times. Once on that day, he was found sitting on the floor with his back to the wall, with a small skin tear on his left hand. Later that same day, he was found on the floor in the hallways. HCFA Ex. 61, at 35-36; Pet. Ex. 8 at 2; Tr. 452-453. One of the Michigan State agency surveyors on the October team saw that Resident 7 had stitches on his forehead and a bandage on his left hand, although HCFA acknowledges that the resident's condition as observed by the surveyor could have been caused by other injuries documented by Petitioner. HCFA Br., at 67.

HCFA showed also that, after Petitioner conducted the "physical restraint elimination" assessment on September 4, 1996, the information maintained by Petitioner was ambiguous and seemingly in conflict on the issue of whether its staff continued or discontinued the use of the lap tray for Resident 7. There was, for example, some testimony by Petitioner's witnesses to suggest that the lap tray was removed from this resident's wheelchair because they thought such a directive had been issued by the August 1996 State agency survey team. See, e.g., Pet. Ex. 8, at 2; Tr. 790, 1058, 1060. There was also some seemingly inconsistent information suggesting that Petitioner wanted to continue the use of the lap tray (e.g., Petitioner's having changed the buckle on the lap tray to a velcro tape on September 4, 1996, and its having ordered a new tray which had not yet arrived by September 11, 1996 ). See HCFA Br., at 67-68. Moreover, the documents maintained by Petitioner did not explain why Resident 7's wheelchair was not equipped with a lap tray when he fell in October 1996. Nor did the documents generated by Petitioner show what measures or devices were used to prevent falls when Resident 7 was not using a lap tray. According to the testimony of a Michigan State agency surveyor, at least one of the falls recorded in Petitioner's records indicated that Resident 7 had fallen out of bed, instead of from a wheelchair where a lap tray could have been inserted. Tr. 445.

HCFA showed also that, notwithstanding the fact that, by October 5, 1996, Petitioner had recorded four falls for Resident 7 since the "physical restraint elimination" assessment dated September 4, 1996, which indicated that he had normal sitting balance, Petitioner did not modify that assessment until October 16, 1996 - while the revisit survey was being conducted. On October 16, 1996, the "physical restraint elimination" assessment was changed to indicate that Resident 7 had a history of falls and recurrent falls. HCFA Ex. 61, at 6. There was no quarterly assessment or care plan for falls until October 16, 1996. HCFA Ex. 61, at 5.

Petitioner defended itself by focusing attention on its efforts to discontinue the use of the tray table as a response to the August 1996 survey findings that the facility was out of compliance with the assessment requirements. Pet. Rep. Br., at 55. It agreed that Resident 7 did experience falls during the period between the August 1996 survey and the October 1996 revisit survey, as described in HCFA's Post-Hearing Brief. Pet. Rep. Br., at 55 (citing HCFA Br., at 67). Without specifically representing that those falls had occurred when the lap tray was not in use or because it had been removed, Petitioner explained in detail its desire to discontinue the use of the tray (even though it had also ordered a new one as a precaution) for fear that, if the surveyors were to observe its use for the same resident, another noncompliance citation would be issued on the revisit survey. Pet. Br., at 75-77; Pet. Rep. Br., at 55-56. According to Petitioner, the lap tray was taken off when Resident 7 was in an activity or with other people. Id. Petitioner represented that "[i]t is painfully clear that the facility was trying desperately to trial Resident #7 off the tray table before the surveyors returned." Pet. Br., at 77. Even after HCFA had specifically set forth, in its Post-Hearing Brief, support for its allegations that Petitioner failed to take the actions necessary to prevent Resident 7's falls, Petitioner continued to re-emphasize that all of the falls noted by HCFA had taken place during the period Petitioner "was attempting to 'trial' Resident #7 without the tray table in hopes that it could be discontinued in time for the revisit survey . . . ." Pet. Rep. Br., at 55.

I find that Petitioner has failed to present a valid defense to the problems identified by HCFA. Instead, Petitioner's arguments show that it misunderstood, to Resident 7's detriment, its obligations under the various inter-related regulations relied upon by HCFA. The record before me contains no mandate by the Michigan State agency surveyors or HCFA to remove the resident's lap tray as a response to Petitioner's failure to conduct the assessment necessary to resolve issues such as whether this resident needed a restraint, and, if so, whether the lap tray was adequate to meet this need while enabling him to attain or maintain his highest practicable level of functioning. The fact that Petitioner chose to interpret the August 1996 citation as meaning that the resident's lap tray should be removed indicates that it did not understand what the regulatory requirements were, or how it could come into compliance with those requirements. The information highlighted by Petitioner's defense also shows that the staff was doing what it thought would benefit Petitioner (i.e., avoiding another assessment citation by removing the tray table), even though this resident was falling repeatedly during the same period. The fact that the August 1996 survey team did not cite Petitioner for any violation of its obligation to prevent accidents should not have led Petitioner to act as if there was no need to do so for Resident 7.

Even though Resident 7's falls coincided with the period of time that Petitioner was removing the lap tray while he was with others or engaged in activities, the coincidence in timing does not constitute adequate support for the conclusion suggested by Petitioner's defense, that is, that "trialing" the removal of the tray table from the resident's wheelchair caused the falls. It is by no means clear from the record that this resident had fallen out of his wheelchair each time. Nor is it clear from the record that the lap tray had been removed from his wheelchair prior to each fall. There is evidence that Resident 7 had also fallen out of bed, to which no lap tray could have been attached. Therefore, Petitioner should have done an accurate and complete assessment of why the falls were occurring in order to provide the appropriate supervision or assistive devices to prevent their recurrence.

Petitioner's failure to exercise diligence to prevent the recurrence of accidents for Resident 7 is also apparent from the record. It was not until October 16, 1996, when the revisit survey was in progress, that Petitioner stated in an assessment document that Resident 7 had a history of falls and recurring falls. The facts show that, by October 5, 1996, Petitioner knew that Resident 7 had already fallen four times and sustained actual injuries from some of those falls. Petitioner could have reasonably anticipated by October 5, 1996 that, if the falls increased in frequency, or if no actions were taken promptly to prevent additional falls, then the injuries to this resident might become more serious. Therefore, even assuming that Petitioner's September 4, 1996 assessment of normal sitting balance had been correct even though Resident 7 had been diagnosed with Parkinson's disease, the falls and their consequences suffered by him between September 9, 1996 and October 5, 1996 should have caused Petitioner to promptly assess the apparent changes in this resident's condition, modify his care plan as appropriate, and provide the supervision and assistive devices that are appropriate to the prevention of such accidents as provided by the updated assessments and care plan. 42 C.F.R. §§ 483.20(b)(4)(iv), 483.20(d), and 483.25(h)(2).

Under the process mandated by the regulations and given the facts of this case, if Petitioner had determined from its assessment and care planning of Resident 7's needs that a lap tray for his wheelchair should be discontinued, then Petitioner should have instituted other measures to prevent him from falling. If, on the other hand, Petitioner had determined that the lap tray was the appropriate device for preventing falls, then the appropriate rationale should appear in Petitioner's records, together with the means by which Petitioner would use to prevent falls when Resident 7 could not have a lap tray in place (when in bed, for example). None of those actions had been taken before the Michigan State agency survey team began its review. Petitioner's omissions had placed Resident 7 at risk for sustaining more falls and likely injuries.

For the foregoing reasons, the evidence concerning Resident 7 is sufficient to support the conclusion that Petitioner was out of substantial compliance with the requirements for resident assessments and for prevention of accidents to residents. However, I reject HCFA's finding that, because Resident 7 had fallen and suffered injuries between September 9, 1996 and October 5, 1996, Petitioner's noncompliance with 42 C.F.R. § 483.25(h)(2) therefore had caused actual injuries to this resident. This regulation does not encompass the concept of strict liability. Moreover, HCFA's conclusion assumes, without proper evidentiary basis, that Resident 7's falls could have been successfully prevented between September 9, 1996 and October 5, 1996. The evidence introduced by HCFA does not show that there were specific means for preventing this resident's falls which Petitioner should have known of and used if it had done the necessary assessments timely. Therefore, even if Petitioner had complied with the requirements of the cited regulations by having timely conducted a comprehensive and accurate assessment of the resident's falls, by having formulated a relevant care plan in accordance with the best judgment of an interdisciplinary team, and by having provided the supervision or assistive devices in accordance with the assessments and care plan, there still would have been no guarantee that any of the four falls Resident 7 sustained between September 8, 1996 and October 5, 1996 would have been prevented.

2. Resident 5 of the October 1996 Resurvey.

The Michigan State agency revisit survey team found problems similar to Resident 7's when they observed and reviewed the records of Resident 5.

HCFA used Resident 5 of the second survey as an example of Petitioner's failure to comply substantially with the comprehensive assessment and care plan requirements set forth in 42 C.F.R. § 483.20(b) and (d), as well as the portion of the quality of care regulation which required Petitioner to provide, in accordance with the resident's comprehensive assessments and care plan, the supervision and assistive devices that are adequate to prevent accidents, 42 C.F.R. § 483.25(h)(2). I find that HCFA's conclusions are supported by a preponderance of the evidence concerning Resident 5.

One of the Michigan State agency surveyors saw that Resident 5 had a cut on her forehead (which was healing) and that she appeared combative and resistant when the staff was providing her with care. The surveyor's review of this resident's records showed numerous documented entries concerning her combativeness and resistance to care. HCFA Ex. 59, at 3; Tr. 476-477. Some of the reports described a high degree of resistance and combativeness. For example, the May 1996 social work quarterly review stated that she was continuing to resist Activities of Daily Living (ADL) care to the point of striking out at staff on occasions. Pet. Ex. 165, at 2. Another note stated that in July 1996, she continued to strip off clothes and fight with staff. Pet. Ex. 168, at 1; HCFA Ex. 59, at 3. Petitioner confirmed at the hearing that Resident 5 was combative and resistive to care. Tr. 1049-1050.

The previous annual MDS dated November 19, 1995, and quarterly MDS updates done by Petitioner, dated November 19, 1995, February 14, 1996, April 30, 1996, and July 24, 1996, respectively, also showed that this resident had body control problems and dementia, which placed her at risk for falls. Tr. 472-473; Pet. Exs. 169-172, at 2-3, respectively. However, this resident's behavioral problems were not noted in those MDS documents. Id.

Since Resident 5's combativeness and resistence to care were improperly omitted from the MDS, Petitioner did not assess these behavioral problems for their causes for Resident 5. Additionally, even though her body control problems were noted in the aforementioned MDS forms and further assessments for falls should have been done, the assessments for falls were done inadequately. Petitioner's staff stated in the falls RAP for this resident that the risk for falls would be addressed on her ADL care plan. HCFA Ex. 59, at 10; Pet. Ex. 173, at 1. However, the ADL care plan was silent about the means for positioning Resident 5 to maintain stability while she was seated. HCFA Ex. 59, at 12; Tr. 474. Due to the incomplete assessments, no individualized intervention measures were developed to address this resident's combativeness, and the care plan developed to respond to her potential for falls was incomplete.

For Resident 5's combativeness, Petitioner alleged the use of only "standard interventions," which its aides should have known to apply in the absence of directives in the care plan. Thus, Petitioner used this rationale to justify its failure to incorporate into Resident 5's care plan individualized methods to address her combativeness. Pet. Br., at 71-72. However, the problems with this approach noted by HCFA are two-fold: the "standard interventions" were not individualized for this resident, as required by law; moreover, Petitioner did not develop the required individualized interventions for the care plan even after the "standard" ones proved unsuccessful.

HCFA noted also that, on September 27, 1996, Resident 5 fell out of her wheelchair. Tr. 471. She sustained a cut to her forehead, which required stitching in the emergency room. HCFA Ex. 59, at 8-9, 22, 25.

In its defense, Petitioner noted that the survey report had mistakenly referred to Resident 5 as a male instead of a female. Pet. Br., at 77. Petitioner also criticized a portion of a Michigan State agency surveyor's testimony, which Petitioner interpreted to mean that Resident 5 had fallen out of her wheelchair due to the facility's failure to address her combativeness in its assessments and the care plan. Pet. Br., at 66. Petitioner argued that it was in compliance with the relevant regulatory requirements because, until September 27, 1996, Resident 5 had not fallen for almost one and one-half years. Pet. Rep. Br., at 56-57. Moreover, Petitioner argued that this resident's potential for falls was not "a reality" because she had no history for falls. Id. Petitioner observed that: "Quite frankly, everyone has a potential for falls." Pet. Rep. Br., at 57. Petitioner acknowledged that the information in the MDS "triggered" a RAP assessment for falls. Id. However, its staff decided not to do an assessment for falls (nor make provisions in the care plan for such a risk) because, in the staff's opinion, the "triggered condition" would not affect the resident's functioning or well-being. Id.

I reject Petitioner's defenses. HCFA acknowledged that the surveyor's report misidentified Resident 5 as a male. HCFA Br., at 69. The facts noted by both parties leave no doubt that Resident 5, a female, was the individual observed and discussed during the October resurvey. The briefs HCFA filed after the hearing do not contain any argument that this resident fell out of her wheelchair due to Petitioner's failure to deal with her combativeness in the assessments and care plan. Although HCFA's position is not clear on this possible relationship, I think the evidence establishes with sufficient clarity that Resident 5 was not properly receiving the necessary care for her ADL due to Petitioner's failure to address this resident's combativeness or resistance to such care. Petitioner failed to deal with the resistance or combativeness in an individualized manner with use of the appropriate process, even after the unstated "standard" techniques appeared to have been unsuccessful. Without doubt, the ADL care was necessary to Resident 5, or Petitioner's staff would not have been attempting to deliver it despite her resistance. Therefore, Petitioner's ineffective and inconsistent delivery of those services, due to its failure to address her combativeness appropriately, placed her at risk for sustaining more than minimal harm to her physical and psychosocial well-being.

A preponderance of the evidence leads reasonably to the additional conclusion that Resident 5 was placed at a risk for sustaining more than minimal harm by Petitioner's omissions under the requirements for providing supervision or assistive devices appropriate for the prevention of falls. Petitioner's argument that everyone is at risk for falls disregards the regulation's emphasis on treating each resident as an individual. Petitioner's argument also disregards the fact that not everyone suffers from dementia and body control problems, as Resident 5 did. Nor does everyone sit in a wheelchair as she did. The potential for more than minimal harm satisfies the definition of noncompliance, and, contrary to Petitioner's argument, the potential does not have to become a reality before Petitioner assumes the duty to supervise, or to provide assistive devices, for the prevention of falls in accordance with the resident's assessments and care plan. The fact that this resident, with dementia and balance problems, had not fallen for over a year did not justify Petitioner's asserted determination to disregard the RAP trigger to assess for falls. Since the prevention of falls should be done in accordance with the resident's assessments and care plan, Petitioner's arguments erroneously suggest that necessary assessments and care plans should be done only if the resident had actually fallen in recent times.

Additionally, Petitioner's arguments do not quite meet HCFA's showing that the resident assessment for falls was incomplete. HCFA did not allege that no assessment was done for falls. Instead, HCFA showed that Petitioner committed to do a falls assessment in the care plan for her ADL, but that document contained no information about positioning her to avoid falls when she was sitting in her wheelchair. More than minimal harm could have resulted to Resident 5, who had been given an incomplete care plan for preventing falls from her wheelchair and, therefore, could not receive from Petitioner the supervision services or assistive devices missing from that care plan.

Based on the same reasons as set forth above for Resident 7, I find only that Resident 5 was placed at risk for more than minimal harm by Petitioner's omissions under the regulations governing assessments, care plans, and the provision of supervision or assistive devices to prevent falls. I do not adopt HCFA's conclusion that, because Resident 5 fell out of her wheelchair on September 27, 1996, the flaws in Petitioner's assessment, care planning, and supervision of Resident 5 have caused her actual harm. A resident may still fall even though the facility has followed the required procedures and done all that was reasonable and possible to prevent the resident from falling.

3. Resident 4 of the October 1996 Revisit Survey.

With use of Resident 4's situation, HCFA proved that Petitioner was out of substantial compliance with the following requirements:

-- 42 C.F.R. § 483.20(b), ("Comprehensive assessments"); and

-- 42 C.F.R. § 483.20(d), (for preparing written care plans appropriate to each resident's right to attain or maintain the highest practicable level of well-being).

Resident 4 was admitted by Petitioner on August 23, 1996, shortly after the first survey had been conducted. This resident was admitted for the treatment of two Stage IV pressure ulcers. HCFA Ex. 58, at 13. The pressure ulcers should have been identified in an accurately and comprehensively completed MDS, which should have then triggered the creation of a RAP for pressure sores. Depending on the outcome of the pressure sore RAP, an appropriate care plan then could have been prepared for Resident 4. 42 C.F.R. § 483.20(d). However, the Michigan State agency surveyor was unable to locate a pressure ulcer RAP for Resident 4. Tr. 431-432. Therefore, HCFA has taken the position that more than minimal harm could have resulted to Resident 4 due to Petitioner's failure to conduct a comprehensive assessment of the pre-existing pressure sores upon admission.

HCFA pointed out correctly that Petitioner has not offered to introduce into evidence any MDS or pressure sore RAP for Resident 4. HCFA Br., at 72. Thus, the relevant finding of the second survey team (that no comprehensive assessment had been completed for Resident 14) stands unrebutted. However, it is not HCFA's contention that Petitioner was unaware of Resident 4's pressure sores on admission. HCFA acknowledged Petitioner's efforts to create an interim pressure ulcer care plan on August 23, 1996. Id. In so doing, HCFA also noted that the creation of such an interim care plan did not relieve Petitioner of its obligation to complete a comprehensive assessment as required by 42 C.F.R. § 483.20(b), so that the interdisciplinary team charged with creating the required care plan based on the completed assessment could then modify the interim plan as appropriate. 42 C.F.R. § 483.20(d). I find HCFA's legal interpretation to be correct.

Petitioner defended itself on the basis that Resident 4 was not in any real danger because the size of the wound had been reduced. Pet. Rep. Br., at 57.(35) In so arguing, Petitioner attempted to miscast HCFA's noncompliance citation as one which found fault with the timing of the comprehensive assessment, as opposed to one addressing Petitioner's failure to conduct the assessment comprehensively for Resident 4. Id.(36) By miscasting the citation, Petitioner re-emphasized its continuing objection that "without affirmative evidence [from HCFA] that the tardiness of Resident #4's RAP for pressure sore is directly responsible for some lack of care and treatment, this should not rise to more than the potential for more than minimal harm." Id.

For many of the same reasons set forth previously, I reject this defense of Petitioner's failure to assess Resident 4 comprehensively. What Petitioner has continued to say is, in essence, that I should accept that its staff has the know-how to deliver appropriate care for each resident without following the comprehensive evaluation and planning procedures mandated by the regulations, which are intended to ensure oversight through the use of objective criteria for the benefit of residents. Even without the obvious legal flaws, this argument by Petitioner is untenable given the numerous problems with Petitioner's records, which were likely caused by its staff's inadequate training, carelessness, or lack of concern. The contention that Resident 4's wound size had decreased merely shows, at best, that no actual harm was caused by Petitioner. It does not show that, when Petitioner failed to do the comprehensive assessment for the pressure sores as required, there was any guarantee that the resident would not suffer harm due to the omission. Therefore, I conclude, based on the facts before me, that Resident 4 was placed by Petitioner at risk for more than minimal harm.

Moreover, I find significant that Petitioner's failure to assess Resident 4 comprehensively for pressure sores occurred shortly after the first survey, for which noncompliance citations were issued for very similar problems. The resurvey was conducted pursuant to Petitioner's allegations that it had come into compliance with regulations such as 42 C.F.R. § 483.20(b). The resurvey findings concerning Resident 4 show that Petitioner was continuing its prior noncompliance for the same asserted reasons as before. Either it was still unable to understand, or it was still not willing to follow, the requirements of 42 C.F.R. § 483.20(b).

Under the corollary citation against Petitioner for failing to preparing an comprehensive care plan appropriate to Resident 4's needs, HCFA introduced evidence showing problems with the care of the indwelling catheter that this resident was admitted with. Petitioner's records show its awareness that, after admitting her on August 23, 1999, she had pulled out her catheter several times. Pet. Ex. 155, at 5. For example, the catheter was pulled out on three consecutive days during late September 1996. Id. However, Petitioner did not conduct an assessment of how or why the catheter was pulled out. A Michigan State agency surveyor testified about several possibilities. In addition to the possibility that Resident 4 was pulling it out herself due to pain or discomfort, there was also the possibility that the catheter was pulled out because it had gotten caught on something. Tr. 432-435. The latter possibility was raised by the State agency surveyor's observation that Resident 4 was not wearing any leg strap to hold the catheter in place. Tr. 432. The State agency surveyor's additional observation that Resident 4's catheter was stretched taut while she was being repositioned also raised the additional possibility that the staff could have pulled out the catheter accidentally. Id. In any event, because no assessment was made of how or why Resident 4's catheter had been pulled out, Petitioner could not and did not make individualized and appropriate provisions for addressing the problem in this resident's care plan. Appropriate preventative measures should have been included in the care plan because having an indwelling catheter pulled out by accident would not only cause significant discomfort, but it could also cause physical damage, e.g., tearing, bleeding, and infection, especially if the indwelling balloon portion remained inflated when the catheter is being pulled out. Tr. 433-434.

Petitioner agreed that having a catheter pulled out can be traumatic. Pet. Rep. Br., at 60. It also noted that Resident 4 was a schizophrenic and very confused and paranoid at times. Id. Petitioner did not deny HCFA's finding that this resident's care plan did not describe the specific actions staff was to take to prevent the removal of her catheter. Pet. Br., 60, 69-70. Petitioner also did not deny that such an omission from the care plan was caused by its failure to assess why and how this particular resident's catheter was being removed. Id. Nor did Petitioner deny HCFA's specific contention that the term "standard catheter care" used in the care plan was generic and failed to address the individualized needs of Resident 4, as required by 42 C.F.R. § 483.20(d). HCFA Br., at 76; Pet. Br., at 69-70; Pet. Rep. Br., at 60.

Instead, Petitioner argued that Resident 4 had not been placed at risk for more than minimal harm because Petitioner had delivered to Resident 4 various intervention services listed by the Michigan State agency surveyor during the hearing. Pet. Br., at 69-70; Pet. Rep. Br., at 60. Petitioner has miscast the information provided by the surveyor. The State agency surveyor listed several possible interventions based on the different hypothetical causes which Petitioner had failed to assess for Resident 4.(37) She listed these various possibilities in order to show that successful prevention should not be considered an impossibility, if one knew why Resident 4's catheter was removed. The surveyor's testimony did not suggest that Petitioner should have refrained from using the knowledge of the interdisciplinary team that it was required to convene in order to prepare a comprehensive and individualized care plan for each resident, once the comprehensive assessment process has been completed for that resident. Additionally, nothing in the State agency surveyor's testimony was in conflict with the regulation's requirement that the provisions of each individualized care plan contain specified goals and timetables for evaluating the success or failure of any specified interventions. The surveyor did not indicate that her examples of possible interventions should be implemented for all residents; nor did she suggest that they should be incorporated into any resident's written care plan without specifying in writing those criteria which would be used to determine when the interventions should be discontinued or modified.

I reject also Petitioner's argument that it was in substantial compliance with the care plan requirements because its failure to include in the plan those interventions that were actually given to Resident 4 was because those interventions were unsuccessful.(38) Pet. Rep. Br., at 60, which states: "If an intervention is ineffective, the facility is certainly not going to place it on the care plan." This argument missed the mark. I emphasize again that, after the comprehensive resident assessment has been completed, an interdisciplinary team of appropriate composition was supposed to have set forth in a written care plan the criteria for determining the effectiveness of any intervention that team thought was needed address the particular problems of the resident. The scenario suggested by Petitioner's argument is at odds with those actions it should have taken to prepare Resident 4's care plan in order to attain compliance with the requirements of 42 C.F.R. § 483.20(d) after the first survey.

I conclude that Petitioner has failed to rebut HCFA's showing that Resident 4 was placed at risk for more than minimal harm due to the problems related to her written care plan. The best that can be said for Petitioner's evidence and arguments on this issue is that it had delivered various intervention services to Resident 4 which were not specifically described in the care plan, which may or may not have been appropriate to her needs, and which were thought to be ineffective by its staff. In other words, Resident 4 was subjected to interventions which had not been determined to be appropriate to her problems, which she may not have needed, and which were not identified in her care plan along with the other requisite information for gauging their effectiveness. These facts do not lend support to Petitioner's conclusion that it had acted in substantial compliance with the care plan requirements for Resident 4.

4. Resident 10 of the October 1996 Revisit Survey.

HCFA has successfully proven, with use of Resident 10 of the revisit survey, that Petitioner was out of substantial compliance with its obligation to ensure that, in accordance with the comprehensive assessment and plan of care, each resident's regimen remains free of unnecessary drugs. 42 C.F.R. § 483.25(l)(1). The regulation gives examples of a drug's use in defining "unnecessary drug." Any drug "when used . . .[w]ithout adequate monitoring . . . ." is included in the definition of an "unnecessary drug." 42 C.F.R. § 483.25(l)(1)(iii).

In the case of Resident 10, Petitioner failed to monitor Resident 10's drug regimen in accordance with the physician's order, and then, in response to the noncompliance citation, Petitioner introduced the testimony of this resident's attending physician to persuade me that Petitioner's discontinuation of monitoring on its own initiative should be viewed as harmless error.

Petitioner did not dispute the essential facts underlying the citation issued by HCFA. Resident 10 was re-admitted to Petitioner's facility during September of 1996 with a physician's order for a daily dose of the medication Coumadin. Additionally, when Resident 10 was re-admitted, there was also a related physician's order, dated September 13, 1996, for this resident's protein level and INR(39) reading to be tested daily until a therapeutic level was reached. These physician's orders, issued initially upon Resident 10's re-admission, were made applicable for the month of October 1996, as well by the directive later issued by the physician on September 28, 1996.

Petitioner also did not submit any evidence to dispute HCFA's findings that, according to Petitioner's own records, Resident 10's protein and INR levels had been checked while he was still hospitalized on September 11 and 12, 1996, but, after readmitting him on September 13, 1996, Petitioner performed no such test until October 15, 1996.

Petitioner has also offered no evidence to dispute HCFA's finding that between September 13, 1996 and October 15, 1996: no physician had changed the prior order for the daily dosage of Coumadin; no physician had authorized the discontinuation of the previously ordered tests for measuring protein and INR levels each day until a "therapeutic level" was reached; and no physician had instructed Petitioner to use any unique standards or numerical values in determining whether a "therapeutic level" had been attained for Resident 10.

HCFA pointed out that the standard INR range is between 2.0 and 3.0. HCFA Br., at 85 n. 102; HCFA Ex. 64, at 14-15; accord, Tr. 1024. Measured against this standard INR range, the 1.0 reading taken on September 11 and 12, 1996 (immediately before Resident 10's readmission) showed that Resident 10's medication was at the sub-therapeutic level. See, HCFA Br., 85. The reading of 1.7 taken on October 15, 1996 would also be at the sub-therapeutic level when measured against the standard INR range. Id., at 85-86. Therefore, based on all of the foregoing uncontested facts, HCFA showed that, in the absence of any doctor's order for Petitioner to apply a different INR norm or standard, Petitioner should have followed the doctor's orders to continue the daily test on each day following Resident 10's readmission date of September 13, 1996, as each of the INR readings of record should have alerted Petitioner that a therapeutic level had not yet been attained.

Petitioner's defense consisted of showing that: Dr. VanOosterhout, Resident 10's attending physician, had initialed the lab results on October 18, 1996, after Petitioner had skipped performing those tests for over a month; that there are different therapeutic levels for different patients, even though Dr. VanOosterhout had not told Petitioner's staff what Resident 10's appropriate level should be when he ordered them to conduct the test each day until the therapeutic level was reached; that Dr. VanOosterhout had no concerns about Petitioner's failure to perform the test daily, even though he had earlier issued the orders to perform daily tests until an unspecified therapeutic range was reached and had never changed those orders, and Petitioner neither requested clarification of those orders nor authorization to deviate from them.

According to Petitioner, "Dr. VanOosterhout simply explain[ed] that he had no explanation as to why he did not discontinue the order for the daily INR levels (Tr. p. 1027)." Pet. Br., at 78. Petitioner contended also that "Dr. VanOosterhout was following Resident 10 very closely, it appears weekly, and he had no concerns regarding the INR levels for Resident #10." Id. Petitioner also relied upon this physician's testimony that, in his opinion, Resident 10's INR levels were atypical but therapeutic nonetheless in light of the other therapies that he was also receiving, e.g., the use of aspirin and Ibuprofen as additional anti-coagulant medications. Id.; Pet. Rep. Br., at 65. Petitioner then alleged that Dr. VanOosterhout had provided the desirable level of "oversight" and that its own omissions were merely in the nature of "lack of documentation," in order to argue that Resident 10 could not have been placed at risk for more than minimal harm. Pet. Br., at 78.

There are significant logical and factual flaws in Petitioner's position. First, the failure to follow a physician's orders to perform certain lab tests over more than a one-month period cannot be properly interpreted as a "lack of documentation." Nor can the inability of Petitioner's staff to make use of a unique "therapeutic level" never disclosed by them by Dr. VanOosterhout be properly construed as a simple "lack of documentation" by Petitioner. The fact that Dr. VanOosterhout never told Petitioner what therapeutic level to use when he ordered the tests to be conducted daily was not a "documentation error," any more than Petitioner's failure to request that piece of critical information from the physician. The commission of these mistakes or omissions by the physician and Petitioner do not support Petitioner's proposition that Resident 10 was not placed at risk for more than minimal harm.

Petitioner erred also in attempting to impute Dr. VanOosterhout's expert knowledge to those members of Petitioner's staff who should have been following his orders. Dr. VanOosterhout's testimony showed that, because he has the training and experience of a physician, he was able to make the medical judgment on October 18, 1996 that the standard norms should not be used for Resident 10 and, instead, a unique or atypical level should be considered therapeutic for him. However, there is no evidence that any of Petitioner's staff members who were responsible for skipping the protein and INR tests for over a month had the same medical knowledge and opinions that were disclosed by Dr. VanOosterhout during the hearing. The evidence of record is uncontroverted that no doctor ever told Petitioner's staff that the tests should be discontinued after Resident 10's readmission on September 13, 1996. Nor had any physician told Petitioner's staff prior to the October 1996 revisit survey that Resident 10's medication had reached its therapeutic level.

Further, even leaving aside the fact that Petitioner's staff lacked Dr. VanOosterhout's medical knowledge about Resident 10's atypical therapeutic level, there is no support in the record for any speculation that Petitioner's staff might have discontinued the daily testing as of September 13, 1996 because they thought the September 11 and 12, 1996 results already indicated the unique therapeutic level. This speculation would also be inconsistent with the fact that Petitioner's staff then resumed the testing on October 15, 1996, when the physician's order required daily testing only until the therapeutic level had been achieved.

As correctly pointed out also by HCFA, the argument that Dr. VanOosterhout was closely monitoring Petitioner's care of Resident 10 is not adequately supported by the facts. HCFA Rep. Br., at 43. HCFA noted as examples Dr. VanOosterhout's testimony that he did not know why he did not discontinue the order for daily testing, and he testified that the omission "wasn't brought to my attention." Id. (citing Tr. 1027). HCFA also noted that, according to the evidence of record, Dr. VanOosterhout had not made his determination about Resident 10's therapeutic level prior to October 18, 1996. HCFA Rep. Br., at 43. Nor could he have made that determination before October 18, 1996, when he initialed the October 15 test results, given the fact that Petitioner had performed no other tests during the intervening period since Resident 10's admission on September 13, 1996. I do not find it believable that, if Dr. VanOosterhout had already thought the September 11, 1996 or September 12, 1996 test readings from the hospital indicated therapeutic levels for Resident 10, he would then have issued orders on September 13, 1996 and September 28, 1996 for Petitioner to do the test each day until the therapeutic level was reached. HCFA Ex. 64, at 11; Tr. 424-427, 1040. There was no alteration of the Coumadin level on September 13, 1996 or thereafter. In sum, the evidence supports HCFA's conclusions that it was not until October 18, 1996, while the second survey was on-going, that Dr. VanOosterhout, in response to that survey, first formed his opinion about Resident 10's test results showing a therapeutic level for his medication.

Without doubt, Dr. VanOosterhout did attempt to show that Petitioner's disregard of his orders to conduct daily tests caused no actual harm to Resident 10 because, if he had thought about the matter sooner or if the omission had been brought to his attention sooner, he would have rescinded those orders. However, HCFA has never alleged actual harm to Resident 10, and the physician's orders were not rescinded during the period in issue. Instead, the evidence showed the potential for more than minimal harm to Resident 10, as caused by Petitioner's unauthorized, unexplained, and illogical disregard for the physician's written order during the time when its staff did not know whether the resident's therapeutic level had been reached, did not know what the therapeutic level appropriate to this resident was, and had not been told by the physician that the standard norms should not be used.

Dr. VanOosterhout explained only why he did not order the testing discontinued. His testimony did not explain why Petitioner's staff had in fact failed to perform the test daily between September 13, 1996 and October 15, 1996. Even if Petitioner's failure to perform the test daily in accordance with the outstanding orders had resulted from the staff's inability to determine the appropriate therapeutic range for Resident 10, Petitioner should have noted the problem immediately and requested the missing information from the physician instead of doing no test for over a month. No legitimate or rational reason for Petitioner's omissions has been indicated by the evidence of record. Even though Dr. VanOosterhout subsequently decided that he did not need the test results he had ordered, Petitioner's staff had no basis for anticipating during the period they were supposed to have been performing the tests (September 13, 1996 to October 14, 1996) that the physician would later find them unnecessary. Those who deliver the day-to-day care to residents lack the knowledge and expertise of physicians.

Additionally, the record in this case showed that Dr. VanOosterhout did not visit or examine Resident 10 each day. For this reason, physicians like Dr. VanOosterhout need information and communications from the nursing home's staff, and those who care for nursing home residents on a day-to-day basis cannot be excused from performing their responsibilities because each resident is under the care of a physician. Nothing before me suggests that it is an acceptable practice for nursing home workers to disregard the content of physician's orders. Therefore, as a general matter, nursing home residents like Resident 10 were placed at risk for more than minimal harm when their care givers either overlooked or ignored instructions which the attending physicians thought important enough to place into written orders.

There are factors unique to this case which also render unreasonable Petitioner's argument that more than minimal harm could not have been caused to Resident 10. To accept Petitioner's argument would necessitate assuming, without proof, that both the physician who ordered the tests, as well as the member of Petitioner's staff who failed to performed the tests, knew during the relevant time period (that is, September 13, 1996 to October 14, 1996) that test results would become unnecessary. Acceptance of Petitioner's argument would also necessitate assuming, without basis, that Petitioner's staff had the prescience to know at the time they failed to conduct the tests that the tests would not disclose any sub-therapeutic level under the standard later provided by Dr. VanOosterhout. As previously explained, no test was performed by Petitioner's staff after Resident 10's admission until October 15, 1996, and it was not until October 18, 1996 that Dr. VanOosterhout initialed the results to indicate that the reading was not inconsistent with a unique therapeutic level. When the physician issued his orders, on September 13, 1996 and September 28, 1996, for the daily tests to be done until a therapeutic level was reached, the physician either did not know or was not of the opinion that the September 11 and 12, 1996 readings signified a therapeutic level. The fact that no test was done for Resident 10 between

September 13, 1996 and October 14, 1996, despite these physician's orders, prevents Petitioner from proving that Dr. VanOosterhout would have interpreted those results, if they existed, as showing a therapeutic level for Resident 10. If, during any of those days from September 13, 1996 to October 14, 1996, Resident 10's medications had been at the sub-therapeutic level by Dr. VanOosterhout's standards, then he could not be alerted to the problem -- since Petitioner's staff was not conducting the daily tests, and Dr. VanOosterhout was not examining his patient daily. For these same reasons, the physician was also unable to obtain prompt information about the degree of any sub-therapeutic level to facilitate any necessary determination as to how Resident 10's Coumadin dosage should be adjusted. Accordingly, I conclude that Petitioner's violation of 42 C.F.R. § 483.25(l)(1)(iii) placed Resident 10 at risk for more than minimal harm during the period from September 13, 1996 to October 14, 1996.

VI. The Reasonableness of the Two CMP Rates Assessed by HCFA.

Below, I explain the following formal findings of fact and conclusions of law:

FFCL #6. HCFA had the authority to impose a CMP for the 92 days from August 9, 1996 to November 8, 1996.

FFCL #7. The reasonableness of the CMP rate must be determined using the criteria specified in 42 C.F.R. § 488.404 and 42 C.F.R. § 488.438(f).

FFCL #8. HCFA considered the criteria contained in 42 C.F.R. §§ 488.404 and 488.438(f) in selecting the CMP rates under review.

FFCL #9. HCFA did not prove, and the record as a whole does not support, the conclusion that the CMP rate of $1,500 per day (assessed for the period from August 9, 1996 through October 17, 1996) is reasonable.

FFCL #10. In selecting the rates of $1,500 for each of the first 70 days and $1,000 per day for the remaining 22 days (October 18, 1996 to November 8, 1996), HCFA attributed improper weight to its findings of "actual harm" and to Petitioner's prior compliance history.

FFCL #11. The rate of $1,000 per day for each of the last 22 days is reasonable for alternative reasons.

FFCL #12. The rate of $1,000 per day for the first 70 days is also reasonable on the basis of the entire record.

A. Discussion of FFCL Nos. 6 and 7.

The CMP remedy imposed by HCFA properly covers the 92 days from August 9, 1996, the date of the first survey finding Petitioner out of substantial compliance, to November 8, 1996, the date Petitioner was found to have attained substantial compliance after the second survey. 42 C.F.R. § 488.440(a) and (b). For this period, HCFA has assessed a total of $127,000. The total CMP amount was calculated by HCFA at two different rates, namely: $1500 per day for the first 70 days of the period (August 9, 1996 to October 17, 1996); and at $1000 per day for the last 22 days of the period (October 18, 1996 to November 8, 1996). HCFA selected both these daily rates from the "lower range" specified by 42 C.F.R. § 488.438(a). HCFA must set the CMP rates in $50 increments, as selected from the "lower range" of $50 to $3,000 per day, when, as here, the facility's deficiencies "do not constitute immediate jeopardy [to residents], but either caused actual harm, or caused no actual harm, but have the potential for more than minimal harm." 42 C.F.R. § 488.438(a)(2).(40)

In an earlier ruling in this case, I have identified or incorporated the other regulatory provisions which must be applied in my review of the CMP rates imposed by HCFA. 1998 Rulings, incorporating my December 11, 1996 ruling in Baltic Country Manor, DAB Docket No. C-96-281. In particular, in my 1998 Rulings I explained how I interpreted and would apply the factor of "[t]he facility's history of noncompliance, including repeated deficiencies." 42 C.F.R. § 488.438(f)(1). Additionally, my decision in Kelsey Memorial Hospital, DAB CR583 (1999), details my interpretation of how a facility's financial condition would impact on the CMP amount. 42 C.F.R. § 488.438(f)(2). That decision also distinguishes the "seriousness of deficiencies" factors specified in 42 C.F.R. § 483.404(b), as incorporated by 42 C.F.R. § 488.438(f)(3), from the "Scope and Severity" letter designations used by HCFA or the surveyors. Kelsey Memorial Hospital, DAB CR583, at 75-78; 81-82.

B. Discussion of FFCL Nos. 8 and 9.

At the in-person hearing, HCFA introduced testimony from an agency official to show her awareness that the criteria specified by 42 C.F.R. § 488.438 had been applied. HCFA's witness testified that she was not personally involved in setting the CMP in controversy, but she had reviewed (presumably for the purpose of litigation) HCFA's official file to ascertain the course of the agency's actions. HCFA Br., at 91. With the use of certain documents, e.g., HCFA Ex. 18, she showed that Petitioner's financial condition had been considered, as had been the "poor performer" status assigned to Petitioner on the basis of certain unappealable deficiencies found during 1994 and 1995, as well as those determinations of "actual harm" made during the two 1996 surveys under review.

However, this line of evidence established only that HCFA had followed the procedures directed by 42 C.F.R. § 488.438(f) and 42 C.F.R. § 488.404. What the witness did not explain adequately was how HCFA's decision-making official had weighed or otherwise evaluated the various sets of relevant facts in order to translate them into the $1,500 per day rate, for example. The rate could have been set as low as $50 a day and as high as $3,000 a day, or at any amounts in between, in $50 increments. Therefore, HCFA's use of the correct process cannot be construed as proof that $1,500 is a reasonable amount, or that the amount resulted from the exercise of sound analysis by a decision-making official who provided no information first-hand.

HCFA then submitted arguments in its post-hearing briefs to support the $1,500 per day rate. According to HCFA's written arguments, the $1,500 rate is appropriate because considerable weight had been given to two sets of facts unique to this case. First, HCFA had assigned to Petitioner the status of a "poor performer" after the August 1996 survey because various adverse survey findings under the quality of care requirements also had been issued against Petitioner during 1995. HCFA Br., at 89-90. These 1995 findings were disclosed in an "OSCAR Report"(41) generated by HCFA's computer system, and they were allegedly given importance by the decision-making official in considering Petitioner's "history of noncompliance, including repeated deficiencies" when setting the CMP rate for the 70-day period covered by the August 1996 survey. Id.; see also 42 C.F.R. § 488.438(f)(1). HCFA noted also that the OSCAR Report showed Petitioner's receipt of what amounted to noncompliance citations in 1994, for various assessment and quality of care problems. Id., at 90.

In addressing the "the seriousness of deficiencies" criterion specified by 42 C.F.R. § 488.404, HCFA stated that considerable weight had been given to its August 1996 findings that actual harm had been caused to residents by Petitioner's noncompliance with the requirement to prevent the development of avoidable pressure sores. HCFA Br., at 95. HCFA pointed out also that there were numerous other examples of noncompliance found during the August 1996 survey, and those examples were inter-related and formed a pattern in numerous instances. Id., at 96.

HCFA noted its interest in maintaining some degree of consistency within each State. HCFA explained that, for this reason, it had considered the Michigan State survey agency's recommendations in this case before applying the federal criteria for setting the CMP rate. HCFA Br., at 89 n.104; HCFA Rep. Br., at 72 n.58. HCFA pointed out that it had modified the amount recommended by the State. Id.

As for the criteria of the facility's financial condition and its degree of culpability, HCFA's position appears to be that they were considered but not used to change the rate set on the basis of the other factors. 42 C.F.R. § 488.438(f)(2) and (4). HCFA summarized the evidence showing that Petitioner's payment of $1,500 per day for 70 days would not put it out of business nor have any significant impact on its sound financial condition. HCFA Br., at 90-94. Even though various financial reports considered by HCFA included those revenues generated by the 55 hospital beds operated by a common owner, Petitioner's Administrator did testify that funds from the nursing home and hospital operations could be used to pay off any CMP for which the nursing home would be found liable. HCFA Br., at 94 (citing Tr. 1121-1122). HCFA then represented also that the degree of Petitioner's culpability was not used by HCFA to either increase or decrease the CMP rate in controversy. HCFA Br., at 97. HCFA specifically noted the specific prohibition against using the absence of culpability, i.e., the absence of "neglect, indifference, or disregard for resident care, comfort or safety", as a mitigating circumstance for reducing an otherwise valid CMP amount. Id.(citing 42 C.F.R. § 488.438(f)(4)).

I find problems only with HCFA's heavy reliance on Petitioner's history of alleged noncompliance during 1995 and on the August 1996 survey findings of actual harm to residents.

HCFA argued in support of the CMP rates that in the August 1996 as well as the October 1996 surveys, there was "at least one deficiency . . . that involved actual harm to residents . . . ." HCFA Br., at 95. Apparently to address the difference between the rate of $1,500 set for the period covered by the August 1996 survey and the $1,000 period set for the October 1996 survey period, HCFA pointed out that a Scope and Severity Level of "H" had been issued during the first survey, and a "G" Level had been issued during the second survey. Id., at 94-95. Both "H" and "G" reflect findings of actual harm to residents, with the former indicating a "pattern" and the latter indicating "isolated examples." Id.

I have explained in other parts of this Decision that the actual harm findings were made by HCFA in error. Therefore, any weight HCFA attributed to its actual harm findings must be eliminated. Since HCFA did not use the "culpability" factor against Petitioner and there has been no showing of any changes in Petitioner's financial condition, I will analyze below HCFA's use of Petitioner's "history" in setting the $1,500 and $1,000 per day rates.

As for HCFA's use of the OSCAR Report's content to establish Petitioner's compliance history, I set forth some relevant legal analysis in my 1998 Rulings for this case. I explained why I would not provide a de novo, on-merit review of those survey findings issued against Petitioner prior to August 1996. I stated that I would not evaluate any evidence for the purpose of altering the October 1995 findings. In the same ruling, I explained also the method I would adopt to avoid conferring an unfair advantage upon HCFA under the "prior compliance history" issue. I ruled that the amount of weight I would give to the determination of the facility's prior noncompliance would depend on how the determination had been reached and the level of review that had been made available to Petitioner. As an example, I noted that I would likely accord little to no weight to a noncompliance finding made in a situation where the facility was given no opportunity to seek any on-merit review or adjudication. 1998 Rulings, at 4-5; see also, 42 C.F.R. § 498.3(b)(12)(findings of noncompliance are appealable in this forum only if HCFA chooses to impose a remedy as a result of those findings).

After having received the 1998 Rulings in this case, HCFA has introduced nothing to show that Petitioner had been afforded the opportunity to appeal the merits of the October 1995 survey findings. Similarly, even though HCFA introduced evidence to establish that its OSCAR report contains information about the citations of noncompliance issued in 1994, HCFA has also failed to show that appeal rights had been made available to Petitioner for challenging those 1994 citations.

My 1998 Rulings were issued after HCFA corrected its notice of the imposition of sanctions, in order to indicate that substandard quality of care had been found against Petitioner during only two of the past three consecutive surveys; the revised content of HCFA's notice letter eliminated my authority to review the merits of the 1995 survey results under 42 C.F.R. § 488.417(b)(2)(applicable when HCFA denies Medicare payments because the State survey agency has cited a facility with substandard quality of care on the last three consecutive standard surveys). 1998 Rulings, at 1-2. Moreover, HCFA has never indicated any disagreement with my determination that Petitioner never acquired a right to appeal the merits of the October 1995 survey findings under 42 C.F.R. § 498.3. 1998 Rulings, at 2.(42) Given these facts, I find that HCFA has attributed undue significance and weight to the findings of noncompliance it issued in 1994 and 1995, the merits of which its own actions have helped make unreviewable before any independent entity.

I understand the argument that a facility that has corrected prior deficiencies need not be treated the same as a facility that has been in continuous compliance. I agree also with the general proposition that enforcement remedies may be imposed by HCFA to encouraged facilities that have fallen out of compliance to attain and maintain continuous compliance. Using the October 1995 survey as an example(43), I note that HCFA had the discretion to impose an enforcement remedy against Petitioner for that very purpose. See 42 C.F.R. §§ 488.404 and 488.406. However, in exercising its nonreviewable discretion under 42 C.F.R. § 488.438(e)(2), HCFA chose not to impose any remedy on the basis of the October 1995 findings. Instead, HCFA allowed Petitioner to achieve substantial compliance by a date certain. Pet. Rep. Br., at 67. Even after Petitioner had made the voluntary corrections found acceptable by HCFA, HCFA had the authority to impose a CMP retroactively on the basis of the October 1995 survey results. 42 C.F.R. § 488.440(a) and (b). HCFA chose not to do so. Under the hearing regulations adopted by the Secretary at 42 C.F.R. Part 498, these exercises of discretion by HCFA triggered no right for Petitioner to seek review of any on-merit disagreement it may have had with the October 1995 survey citations. Nor did Petitioner have the right to bar HCFA from placing any survey findings into its computer system and thereby generate OSCAR Reports in the future.

Under the above-described circumstances, Petitioner's failure to contest the October 1995 noncompliance citations cannot be construed as its admission that the citations were correct. HCFA's exercise of its discretion, coupled with limitations in the hearing regulations, created (if not made attractive also) the opportunity for Petitioner to take the pragmatic course by doing what would be found readily acceptable by HCFA in 1995.(44) The limited information provided by HCFA concerning the 1994 survey results do not indicate that I should reach different conclusions. Further, no regulation, statute, or letter of record from HCFA placed Petitioner on notice that acceptance of the opportunity to correct the alleged noncompliance would be construed in future proceedings as Petitioner's admission to the noncompliance. For these very reasons, HCFA's seeing the 1994 and 1995 citations referenced in its computer generated OSCAR Reports did not imbue the underlying information with any more reliability, credibility, or persuasiveness than they had originally. The underlying information remained, as before, HCFA's allegations of noncompliance which are not subject to on-merit litigation.

In rejecting the amount of weight HCFA gave to Petitioner's prior compliance history in arriving at the $1,500 per day rate for the initial 70 days, I have evaluated also HCFA's selection of a lesser rate ($1,000 per day) for the period covered by the October 1996 revisit survey. HCFA's selection of the lesser rate for the October 1996 survey is at odds with HCFA's arguments about the importance of Petitioner's poor compliance history. At the time HCFA was setting the higher ($1,500) CMP rate for the noncompliance period covered by the August 1996 survey, the OSCAR report of Petitioner's history indicated those noncompliance citations issued for the 1994 and 1995 surveys. By the time HCFA was setting the lower CMP rate ($1,000 per day) for the period of noncompliance covered by the October 1996 survey, Petitioner's history would have necessarily included one more set of noncompliance findings, that is, those from the August 1996 survey, in addition to those issued in 1994 and 1996. HCFA's arguments also indicate that the August 1996 survey results were used to select the $1,000 per day rate. HCFA Br., at 90. Moreover, at the time HCFA was selecting the $1,000 rate, it knew that the August 1996 noncompliance findings were subject to challenge and review under 42 C.F.R. § 498.3(b)(12), because it was issuing an enforcement remedy (i.e., the CMP) against Petitioner. Accordingly, HCFA knew also that the validity of the August 1996 survey findings could be either established or disproved by a preponderance of the evidence if Petitioner chose to exercise it right of appeal. In contrast, the 1994 and 1995 survey findings of noncompliance were, in essence, unproven and unprovable allegations which HCFA chose to maintain.

These obvious and significant differences make unreasonable HCFA's decision to set the CMP at the higher rate of $1,500 per day for the period of August 9, 1996 to October 17, 1996. As noted previously, the factors of financial condition, "culpability," and "actual harm" findings were the constants also used by HCFA in setting the CMP at the lower rate of $1,000 from October 18, 1996 through November 8, 1996. One of the significant variables for the difference between the two rates should have been the results of the August 1996 survey results. That is to say, HCFA should have considered also the August 1996 survey results as part of Petitioner's compliance history when it was setting the rate for October 18, 1996 through November 8, 1996.

In contrast, when HCFA was setting the rate for the period commencing on August 9, 1996, it was able to consider only the findings from 1994 and 1995 as Petitioner's history. Consistent with the notion of fairness, HCFA could have then given greater weight to the August, 1996 survey findings because the administrative review process was available. However, HCFA failed to do so. Moreover, even using HCFA's approach of deeming true and valid those noncompliance citations listed in its OSCAR Report, the reasonableness of the $1,500 per day rate is not consistent with the fact that the facility's history of noncompliance for the relevant time frame consisted only of the 1994 and 1995 survey findings, whereas, the lower $1,000 rate was selected when HCFA had before it a third set of noncompliance findings from the August 1996 survey.

C. Discussion of FFCL Nos. 10, 11, 12.

HCFA has not proved that $1,500 per day for the first 70 days is reasonable in light of the record as a whole. Nevertheless, as HCFA has proved the existence of noncompliance for the period covered by the August 1996 survey and exercised its discretion to impose a CMP for those 70 days, my analysis cannot end with the setting aside $1,500 rate. 42 C.F.R. § 488.438(e)(1). Instead, I am obligated to decide what amount other than $1,500 per day would be reasonable for those 70 days of noncompliance. Id. The same reasonableness analysis must be made also for the remaining 22 days of noncompliance proven by HCFA pursuant to the October 1996 revisit survey, for which HCFA has sought to assess the $1,000 per day rate against Petitioner.

I find the $1,000 per day rate to be reasonable for the entire period from August 9, 1996 until November 8, 1996.

In applying weight to the various criteria specified by the regulations, it is possible to identify several rates which may be reasonable for the periods covered by the two 1996 surveys. However, I have limited my analysis to the reasonableness of the $1,000 per day rate because the only notice Petitioner had was of the $1,500 and $1,000 rates. Petitioner has not had the opportunity to argue against any specific rate that is higher than $1,500, or that is between $1,500 and $1,000. Petitioner itself did not suggest that any rate between $0 and $1,000 would be appropriate, as it did not believe itself liable for any enforcement remedy. Therefore, having found unreasonable HCFA's use of $1,500 per day rate, I considered only the reasonableness of the only other rate ($1,000 per day) for which Petitioner has had notice.

For essentially the same reasons, to the extent possible, I have used HCFA's reasons as a framework for addressing the reasonableness of the $1,000 rate. I accepted as true, for example, HCFA's undisputed findings under the "culpability" criterion. I have re-weighed certain relevant evidence as authorized by 42 C.F.R. § 488.438(e)(3) and (f) only where HCFA's approaches and conclusions were either legally incorrect or unsound given the totality of the record.

Consistent with HCFA's reasoning that Petitioner did not have imposed against it the highest amount allowed for non-immediate jeopardy problems, I note that $1,000 per day is only one-third of the amount the regulation permits for noncompliance which does not cause immediate jeopardy to residents. HCFA Br., at 98. The $1,000 per day rate does not appear to contravene HCFA's legitimate concern for allowing consistency within the State of Michigan. HCFA's evidence established that Petitioner's ability to continue its business will not be significantly affected by the CMP amount. Also, given the invalidity of the actual harm findings issued by HCFA for either of the two 1996 surveys, placing the CMP at one-third of the allowable rate for the entire 72-day period is reasonable in light of the other relevant evidence of record.

The evidence of record concerning the August 1996 and October 1996 surveys established not only Petitioner's failure to comply substantially with several program requirements during each of those two surveys, but also the occurrence of related patterns of problems over time. For the reasons I have noted above, there was the risk of more than minimal harm to identified residents in the survey groups, as well as the potential for harming other unnamed residents, caused by the staff's apparent inability or unwillingness to adhere to those procedures and purposes stated in the regulations. The omissions and mistakes of its staff members were not addressed by Petitioner until after survey citations were issued. The evidence of record did not show that Petitioner was providing sufficient oversight to discover and correct its staff members' errors independent of the Michigan State agency surveyors' interventions.

Even after the noncompliance citations were issued after the August 1996 survey, the corrections made by Petitioner appeared only superficial. As shown by the results of the revisit survey conducted during October 1996, Petitioner had expended inadequate effort to ensure that its staff would adhere to all program requirements. The latter approach would have been proper and reasonable, especially given the numerous assessment and care plan problems identified in the August 1996 survey, which then caused the facility to be out of compliance with not only the assessment and care plan requirements, but several related quality of care requirements also. Additionally, it is the responsibility of each facility to be in substantial compliance with each and every program requirement at all times. The health and well-being of residents cannot be safeguarded adequately if each facility were to make corrections only in response to surveys findings identified on the basis of a limited number of randomly selected samples. Thus, each facility should voluntarily do what is appropriate to ensure that it is in compliance with all program requirements for all residents, no matter which residents had been specifically identified by the surveyors.

In this case, however, Petitioner's remedial efforts after the August 1996 survey were not only unduly narrow but also unsuccessful in several areas. Consequently, the October 1996 revisit survey team correctly identified continuing noncompliance with the resident assessment and care plan requirements, together with continued noncompliance with various related quality of care requirements. Most of these noncompliance problems shared common causes once again. Additionally, the October 1996 resurvey team correctly identified Petitioner's noncompliance with staff training requirements. Petitioner should have been alerted to examine the staff training issue by the findings of the August 1996 survey, which listed many instances of mistakes or omissions by staff members. Those survey findings should have led Petitioner to investigate the causes of the staff's mistakes and omissions, instead of treating the findings as unjustified criticisms of allegedly insignificant documentation errors.

I find especially significant the examples of Petitioner's deficient practices in preparing resident assessments and care plans during the period of 92 days covered by the August 1996 and October 1996 surveys. HCFA noted the importance of these deficient practices in attempting to explain why Petitioner was out of compliance with several "quality of care" requirements as well. HCFA Br., at 12, 66. The regulatory language makes clear that the resident assessment requirements are central to the care plan requirements. Together, the properly produced resident assessment and care plan determine when, which, and how various services are to be delivered to residents in the various areas specified in the quality of care regulation.

The problems discovered during the two 1996 surveys were more than minor record-keeping flaws. Rather, the evidence indicated that errors and omissions in the assessment and care plan documents occurred because the members of Petitioner's staff responsible for those tasks did not follow the procedures and content of the regulations, or they disregarded the purposes specified in the regulations for creating such documents. Instead of assessing, care planning, and delivering services that were appropriate and objectively measurable for results to enable each resident to attain or maintain his highest practicable level of well-being, Petitioner seemed to have lowered this standard with its often repeated observation that no resident exhibited any injury that can be traced directly back to any missing, incorrect, or conflicting information recorded by Petitioner in the assessment and care plan documents. HCFA's inability to prove actual harm to any resident was caused to a significant extent by Petitioner's deficient records and the degenerative nature of the residents' conditions. Therefore, even though HCFA was unable to prove that any resident had suffered actual harm, the evidence of record still showed the very serious nature of Petitioner's repeated noncompliance with several inter-related requirements aimed at improving each resident's physical, psychological, and psychosocial well-being to the maximum extent possible.

I have considered also the logical ramifications of HCFA's representation that "[t]he CMP was lowered [from $1,500 per day ] to $1000/day for the period from October 18, 1996 through November 8, 1996, when the most serious deficiency comprised two examples (isolated) that posed a potential for more than minimal harm." HCFA Br., at 98. Applying the factors identified in and incorporated by 42 C.F.R. § 488.438(f), I find that HCFA has given too much significance to a narrow band of evidence. It should have weighed other relevant evidence of record as well. However, while I reject HCFA's reasons for having set the CMP rate at $1,000 for the 22 days covered by the second survey, I uphold the reasonableness of that amount for the alternative reasons which follow.

The fact of Petitioner's failure to adequately correct its fundamental assessment and care plan errors by the time of the October 1996 revisit survey has greater weight than HCFA's incorrect determination that a "pattern" of actual harm from the August 1996 survey had been reduced to some successful changes or lessened the impact of its deficient practices by the time of the October 1996 revisit survey. No doubt, Petitioner had made changes and lessened the adverse impact of its deficient practices between the two surveys. However, several of its inadequately corrected practices continued to place its residents at risk for at least more than minimal harm, even though HCFA was unable to prove actual harm to any resident for either survey. Petitioner still had no effective process in place by which it could promptly identify and eliminate problems on its own without the input of surveyors. It is even more significant that the evidence established Petitioner's continued noncompliance with many of the same inter-related program requirements. For the reasons noted above, Petitioner was unable to prevent the occurrence of other violations without adequate corrections of its assessment and care plan problems. The findings from the October 1996 revisit survey showed that Petitioner had provided only some superficial solutions to deeply rooted problems.

Even though I have rejected the amount of weight given by HCFA to the 1994 and 1995 survey results in its selection of the $1,500 per day rate for the period covered by the August 1996 survey, Petitioner's compliance history, when viewed in its proper context, helps to make reasonable the $1,000 per day rate for all 72 days covered by the two 1996 surveys. Petitioner did not dispute HCFA's representation that during 1994 and 1995, the equivalent of noncompliance citations were issued against the facility in numerous areas, including alleged resident assessment and care planning problems in 1994 and alleged quality of care and pressure sore problems in 1995. See HCFA Br., at 90. Whether or not the citations issued against Petitioner in 1994 and 1995 were factually and legally supported, the mere receipt of those citations by Petitioner should have alerted it to evaluate its practices and procedures thoroughly so that compliance could be attained (if appropriate) and then maintained. Yet, when the annual certification survey was conducted in August 1996, Petitioner was out of compliance with various fundamental aspects of the assessment, care planning, and quality of care requirements. Therefore, whether or not there was merit to the noncompliance findings made during 1994 and 1995, the reasonableness of the $1,000 per day amount for the 70 days covered by the first 1996 survey is supported by Petitioner's failure to be in substantial compliance by August 1996 even though it has had notice from the 1994 and 1995 survey reports that it needed to remain especially vigilant of its practices in certain areas.

As for the $1,000 per day assessed for the period covered by the October 1996 resurvey, that CMP rate is reasonable also in light of Petitioner's compliance history -- which by then included the outcome of the August 1996 survey as well. The merits of the August 1996 survey findings were not only subject to challenge by Petitioner, but in this proceeding HCFA has proved the validity of most of those findings. Therefore, as a part of Petitioner's compliance history, the August 1996 survey findings have much more weight than the untested and unadjudicated findings issued in 1994 and 1995. The weight of the August 1996 findings as a part of Petitioner's compliance history also has greater significance than the fact that Petitioner had eliminated or reduced some areas of noncompliance by the time of the October 1996 resurvey.

For all of the foregoing reasons, I conclude that the record as a whole makes reasonable the CMP rate of $1,000 for each of the 92 days for which HCFA, by use of the information discovered during the surveys conducted during August 1996 and October 1996, has proven Petitioner's substantial noncompliance with one or more program participation requirements.

VI. Conclusion.

HCFA has proved that Petitioner was out of substantial compliance with one or more program participation requirements for the 92 days from August 9, 1996 through November 7, 1996. Accordingly, HCFA had the authority to impose a CMP against Petitioner for those 92 days. The rate of $1,000 per day is reasonable for each of those 92 days.

JUDGE
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Mimi Hwang Leahy

Administrative Law Judge

FOOTNOTES
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1. The motion, dated April 12, 1999, is styled "Motion Requesting Specific Findings Of Fact And Conclusions Of Law On Lakeland's Compliance With The Medicare Participation Requirements For F-314 For The August 9, 1996 Annual Survey And F-324 For The October 18, 1996 Revisit Survey" (Pet. Motion or motion).

2. Unless otherwise noted, all references herein to the Title 42 Code of Federal Regulations are to the 1996 edition, which is substantially similar to the 1995 edition with regard to provisions governing quality of care, patient assessment and comprehensive care plans, as well as provisions regarding appealable initial determinations and enforcement remedies, e.g., CMPs.

3. HCFA notes also that a designation of "C" or above means that the facility has been found to be out of substantial compliance with the corresponding federal nursing home participation requirement. HCFA Post-Hearing Brief (HCFA Br.), at 7.

4. In publishing the final regulations applicable to nursing home enforcement cases, the agency noted the suggestion that "providers should be permitted to formally appeal both the existence of a deficiency as well as challenge determinations of scope and severity and the remedy imposed." 59 Fed. Reg. 56,178 (1994). The response was as follows:

[I]n the case of most alternative sanctions, the regulations are structured so that whether a facility's noncompliance falls in category 1 or category 2, HCFA and the State have complete discretion to choose from either category . . . . Only a showing that the facility was in substantial compliance would enable the facility to avoid sanctions, and it is this issue that we agree must be subject to challenge.

Id.

5. The agency explained the content of the regulation thus:

Only in the case of civil money penalties could we see the necessity of allowing facilities the opportunity to challenge the level of noncompliance since the amount of these penalties hinges upon discrete levels of noncompliance rather than noncompliance as a whole. Thus, it may be legally significant to a facility facing a $10,000 per day civil money penalty to be able to prove that its noncompliance belonged in category 2, rather than category 3, since in category 2 the largest civil money penalty available . . . would be $3,000 per day. Accordingly, we have revised the rules to allow a facility to challenge the level of noncompliance when a successful challenge on this issue would affect the amount of a civil money penalty that HCFA or a State could collect.

6. In publishing the final regulations, the agency stated in the preamble:

In 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 . . .

59 Fed. Reg. 56,173 (1994).

7. See "Rulings on the Scope of Hearing and on the Burden of Persuasion Allocation," issued in this case on February 12, 1998 (1998 Rulings).

8. HCFA also alleged that Petitioner did not comply with the requirements imposed by 42 C.F.R. §§ 483.10(o) and 483.12(a), which govern the transfer of residents. I do not reach the merits of these transfer citations because the other facts discussed herein are sufficient for resolving the issues of Petitioner's liability for a CMP and the reasonableness of the CMP amount as determined by HCFA.

9. Petitioner herein seeks to rely on the testimony of Dr. Riley Rees concerning the unavoidability of pressure sores. See Pet. Br., at 18, which describes his testimony. I find controlling the content of 42 C.F.R. § 483.25(c), even if the conclusions relied upon by Petitioner had been generally accepted by Dr. Rees's professional peers, or even if those conclusions had stemmed from sufficient research efforts or validation studies with use of an appropriate data base. The testimony that Petitioner relied upon shows that Dr. Rees was giving his own opinions on the matter, and he has not published his opinions to enable others in his field to determine whether the same conclusions could be obtained in independent studies. Moreover, he explained that his opinions were formed on the basis of information concerning patients of a U.S. Department of Veterans Affairs Hospital. Under the Medicare program, for example, nursing homes are supposed to be providing a different level of care than hospitals, to individuals who do not have conditions which are so severe or acute that their physicians would find it medically reasonable and necessary to admit them as inpatients at hospitals. See sections 1812 and 1861 of the Social Security Act (Act), as amended.

For the foregoing reasons, I cannot give the weight to Dr. Rees's conclusions and analysis as urged by Petitioner. All Medicare certified facilities are obligated to follow the approach specified in 42 C.F.R. § 483.25(c). Noncompliance cannot be excused on the basis that certain assumptions and approaches incorporated in the regulation are subject to question by some experts.

10. Petitioner's defense is somewhat at odds with HCFA's position. According to HCFA, the citation concerning Resident 1 stemmed from Petitioner's failure to assess whether a lap tray inserted onto this resident's wheelchair was, in fact, functioning as a restraint given his incontinence problem and the difficulty the resident had in removing the tray due to his Parkinson's disease and balance problems. HCFA Br., at 42-43. The assessment citation was also based on the fact that Petitioner's records were inconsistent on the questions of whether or not Resident 1 needed the use of a restraint device for his own safety, and whether or not the lap tray seen by the surveyors was intended solely to provide a work/activity surface for the reduction of his agitations. Id.

As I will discuss also below, many other inconsistencies and unresolved questions appearing in other residents' records have also led HCFA to cite Petitioner for failing to comply substantially with the requirements to conduct assessments comprehensively and accurately.

11. The MDS is the federally mandated standardized instrument on which each participating facility is to record an overview of the resident's status and function level in the various designated categories. In completing the MDS, the facility should check off appropriate boxes and fill in appropriate numerical values, which would then enable the facility to determine whether particular answers should "trigger" further, more detailed, evaluations of the resident's functional limitations and potentials by using the "Resident Assessment Protocol" (RAP) process. A manual published by HCFA to accompany the MDS form lists the numerical values and responses which constitute "triggers," and it contains guidelines concerning what additional information should be analyzed if such "triggers" are present.

The information contained in the briefs before me indicate that the parties are in agreement that producing a written comprehensive assessment entails, at minimum, the completion of a MDS form, identifying the "triggers" indicated on the MDS form, and performing the RAP process as necessary in each "triggered" area. See, e.g., Pet. Br., at 7-8; HCFA Br., at 39-41.

12. As for Petitioner's objection that the witness who testified on this matter at hearing was not the same individual who had personally examined the documents during the survey (Pet. Br., at 8 n.7), I note that the findings of the Michigan State agency survey team were set out in a report issued to Petitioner long before the commencement of these proceedings. Petitioner has made use of its opportunity to examine its own records on this issue and assert the basis of its disagreement with the conclusion stated in the survey report concerning what was found in Petitioner's documents. Additionally, to the extent Petitioner may be complaining that it was denied the opportunity to cross-examine the Michigan State agency surveyor who personally reviewed Petitioner's records during the survey, I point out that Petitioner did not avail itself of the opportunity to request that this surveyor appear at the hearing under compulsory process.

The foregoing analysis applies also to the similar objections made by Petitioner to the testimony of other Michigan State agency surveyors also called by HCFA to explain the survey teams' findings about other residents or to introduce the notes of other surveyors into the record.

13. HCFA showed examples of such mistakes and oversights in the assessment records of Resident 9 and Resident 8. HCFA Br., at 46-47. For Resident 9, Petitioner's staff told the surveyor that RAP assessments for pressure sores and incontinence, both of which had been triggered by the MDS for Resident 9 had not been done. Additionally, the RAP summary sheet prepared by Petitioner for this resident did not indicate the location of the RAPs for nutrition and psychoactive medication, both of which should have been triggered also by the MDS the staff had completed. HCFA points out that, even though Petitioner now argues that a psychoactive medication RAP was not necessary, there was a check placed on Petitioner's RAP summary sheet to indicate the facility's awareness that such a RAP was necessary and had been triggered. Id., at 47; Pet. Ex. 58, at 8, line 17.

To prove that Petitioner was out of substantial compliance with 42 C.F.R. § 483.25(e)(2) because it allowed Resident 8's joint mobility to decline over an eight months period from lack of proper assessments or lack of proper care, HCFA noted also that Resident 8's RAP summary sheet did not indicate where triggered RAP information could be found. HCFA Br., at 46. Despite the decline in joint mobility indicated in other parts of Petitioner's records for Resident 8 during the prior months, its staff then incorrectly recorded the absence of any change on the range of motion assessment allegedly done on March 13, 1996; this resident's range of motion exercises were therefore reduced from five to three times a week. By the time of the August 1996 survey, the staff had been told to cut back from full range of motion exercises and perform, instead, only flexion and extension of Resident 8's joints. See also, HCFA Br., at 33 (citing Petitioner's records (Pet. Ex. 57, at 1-2)) showing the decreased range of motion measurements taken for several months before the March 1996 assessment.

14. According to the definition appearing in a HHS publication HCFA submitted, entitled "Clinical Practice Guidelines, Number 15 -- Treatment of Pressure Sores," four stages (I to IV) are assigned to denote the severity of the pressure sores, with Stage IV being the most severe. HCFA Ex. 25, at 12. A Stage IV ulcer is: "Full thickness skin loss with extensive destruction, tissue necrosis, or damage to muscle, bone, or supporting structures (e.g., tendon, joint capsule)." Id. A Stage III ulcer is: "Full thickness skin loss involving damage to or necrosis of subcutaneous tissue that may extend down to, but not through, underlying fascia. The ulcer presents clinically as a deep crater with or without undermining adjacent tissue." Id. A Stage II ulcer is: "Partial thickness skin loss involving epidermis, dermis, or both. The ulcer is superficial and presents clinically as an abrasion, blister, or shallow crater." Id.

15. The regulation at 42 C.F.R. § 483.20(c) requires accuracy in assessments and specifies, moreover, that "[e]ach assessment must be conducted or coordinated by a registered nurse who signs and certifies the completion of the assessment." These regulatory requirements mirror the statutory language. Act, section 1819(b)(3). It would not be logical to interpret these requirements as meaning that the Petitioner has responsibility for ensuring that the assessment is done accurately only when a Registered Nurse (RN) personally performs all of the assessments. Instead, each certified facility, like Petitioner, has ultimate responsibility for completing resident assessments timely and accurately, no matter whom it has placed in charge of performing specific tasks. Therefore, I reject Petitioner's arguments that it has no liability under the assessment requirements of 42 C.F.R. § 483.20 because its RN Coordinator had verified that all blanks of the form had been filled in and signed by others.

HCFA's evidence on Resident 8, which also is discussed below in this Decision, demonstrates that a comprehensive care plan should be prepared only after the RN Coordinator, in certifying the completeness of the assessment document, has also checked the content for accuracy and provided updated the information as necessary. See HCFA Br., at 45. Such evidence shows, for example, that when a Licensed Practical Nurse (LPN) completed her portion of the MDS on May 23, 1996, she noted on the MDS that Resident 8 had no indwelling catheter. About a week later, a catheter was inserted into Resident 8 for reasons not clear from Petitioner's records. On June 5, 1996, when the RN Assessment Coordinator certified completion of the MDS, she did not correct the LPN's initial information by indicating that this resident was now using an indwelling catheter. Consequently, the RAP documents for Resident 8 indicated also that there was no indwelling catheter to be assessed; and, the resident's care plan failed to indicate why the catheter was inserted, or the circumstances under which the catheter should be removed.

16. The comprehensive assessment identified abrasions, wound, and surgical wound care. HCFA Ex. 40 at 15; Tr. 41. Additionally, a social assessment identified this resident as bedfast, presumably because she was unable to bear weight due to her broken left ankle. Pet. Ex. 10, at 2.

17. The physician, Dr. Keith VanOosterhout, later testified at the hearing that he never actually examined Resident 2's heel on admission, as she was being followed by an orthopedic surgeon. Tr. 1003-1004.

18. HCFA Exhibit 27 is a HCFA document entitled "Long Term Care Resident Assessment Instrument User's Manual, Version 2.0" (User's Manual), dated October 1995.

19. Other evidence introduced by HCFA concerning Petitioner's assessments of Resident 16 further undercuts the persuasiveness of Petitioner's intimations that it had a consistent practice of performing a RAP assessment for skin ulcer whenever its staff has placed onto a resident's MDS form the presence of a skin ulcer. As pointed out by HCFA, the MDS Petitioner had belatedly completed for Resident 16, over two months after her admission, showed on one particular line of that form (Pet. Ex. 126, at 6, Line M2) that she had one pressure ulcer. That MDS entry at Line M2 should have triggered a pressure ulcer RAP assessment even under Petitioner's arguments. Moreover, the RAP Trigger Legend provides that an entry on that line should cause the creation of a pressure ulcer RAP. See, HCFA Ex. 27, at 43. However, no pressure ulcer RAP was done for Resident 16 by Petitioner. HCFA Br., at 49 (citing Pet. Ex. 126, at 8).

20. Tr. 673. When asked to explain "Duoderm," Ms. Enochs stated that "[i]ts almost like another piece of skin that's thick that, in time, as you're using this, kind of meshes with the skin to provide a protective barrier and help debride the wounds." Tr. 673-674.

21. HCFA acknowledges that the care plan entries dated June 28, 1996 concerning Resident 2's mood swings and other behavioral problems were completed within seven (7) days after the comprehensive assessment process, which was not certified as having been completed for nearly two months after Petitioner had admitted her. HCFA Br., at 54 n. 63. Even though I disagree with HCFA that the regulatory deadlines mean that Petitioner had a total of 21 days post-admission to complete the resident's care plan (14 days for the assessments, plus 7 days for the care plan), I agree with HCFA's conclusions concerning the results of Petitioner's having taken approximately two months for the completion of the two inter-related processes.

According to the very words used in the regulation, the deadline for completing a care plan begins to run from the date the comprehensive assessment is completed -- not from the resident's admission date. A care plan containing the necessary information cannot be prepared until the resident has been fully assessed. Therefore, a delay in the comprehensive assessment does not, by itself, signify that the care plan was prepared late as well. Nevertheless, the error in HCFA's legal interpretation does not render invalid its conclusions concerning the harm to Resident 2. The purpose of the assessment process is to enable the preparation of an appropriate care plan by the facility, so that the resident may receive the needed services in accordance with that care plan. Had Petitioner completed each of these inter-related processes timely, Resident 2 could have certainly begun to receive the needed services within 21 days or less of her admission. It made no practical difference to Resident 2's health precisely which regulatory violation caused the delay in Petitioner's delivery of the services she needed.

22. Petitioner has submitted the same defense with respect to an alleged "care plan" for Resident 14. Petitioner asserts that its Exhibit 104, "which is the Nurses' Notes for Resident 14 from the time of his admission until he expired on August 30, 1996, shows that this resident was receiving extensive and meticulous care despite the fact that this may not have been written on a document entitled 'care plan.'" Pet Br., at 26. I note that, in addition to the other obvious flaws flowing from this argument, even Petitioner does not attempt to use the term "comprehensive care plan" when referring to the nursing notes.

23. I find also that, based on these facts, HCFA reasonably concluded also that, even after the insertion of the catheter, Petitioner had the notice necessary for correcting its omissions before the survey by conducting the appropriate assessments about why (or if) the catheter was needed, and whether (or when) discontinuation of its use would be appropriate.

24. Of course, the safeguards are effective only if those persons delivering the care know where the written plans are located, have read them, and are aware of their obligation to deliver services in accordance with the written plans.

25. HCFA mentioned this citation also in the portions of its initial Post-Hearing Brief discussing the care plan requirements under 42 C.F.R. § 483.20(d). HCFA Br., at 57.

26. There is no dispute that a Foley catheter is an indwelling catheter retained in the bladder by a balloon inflated with air or liquid.

27. Tr. 1029.

28. However, according to Petitioner, there was no written order to decrease the range of motion to strictly flexion and extension. Pet. Br., at 56. Petitioner then suggested that its staff's incomplete documentation of information may have caused HCFA to form an incorrect conclusion:

Given that the directions had not changed, this begs the question of whether the restorative aide responsible for the documentation was merely checking off that they had performed the ROM to that extremity without checking off all the exercises under each extremity.

Id.

I have accepted HCFA's conclusion instead of Petitioner's conclusion on this question, because Petitioner was in control of the information placed into its own records, and Petitioner had the opportunity and responsibility for discovering from its unnamed restorative aide what was in fact being done for Resident 8. Petitioner cannot gain an advantage from the ambiguities created by its staff, especially after having failed to investigate and resolve them. Moreover, even if the conclusion tendered by Petitioner were as reasonable and well-founded on the available evidence as HCFA's conclusion is, my 1998 Rulings placed the burden of persuasion (or the risk of non-persuasion) upon Petitioner.

29. HCFA acknowledges that it cannot prove that each individual resident denied the needed hygiene services had been placed at risk for more than minimal harm. See, HCFA Br., at 30 n.28. However, the facts adequately support its conclusion that a pattern of deficiencies under 42 C.F.R. § 483.25(a)(3) existed and that pattern of deficiencies had placed more than one resident at risk for sustaining more than minimal psychological and physical harm. The other dependent residents used by HCFA to prove the foregoing propositions were: Resident 11, who was incontinent and was seen by the Michigan State agency surveyor to have received a bed-bath backwards - from the perineum and buttocks areas to the face - without the aide's having washed his hands or changing gloves in between; Resident 21, who was seen by the State agency surveyor to have a whitish-beige coating on her tongue, and also seen to have been left in a wheelchair for over an hour in a public room - with no staff member to cover her exposed perineal area after her lap robe fell to the floor; later, Resident 21 was observed to have been returned to her room with her feet dragging on the floor after the aide made unsuccessful attempts to place them on the wheelchair foot rests; Resident 9, who was incontinent and was seen by the State agency surveyor to have been lying on a wet pad which, given the odor and appearance also noted by the surveyor, had probably been wet for a long time; Resident 8, also a dependent, tube-fed resident who, like Residents 31 and 13, was seen by the State agency surveyor to have had matters caked on her tongue due to poor oral care; Resident 14, whose plan of care specified "good skin care," but who was observed by the State agency surveyor to have very dry feet on two days -- which increased his risk for suffering skin break-downs given that he already had sores on his feet; and Resident 15, who had numerous pressures sores and was at risk for additional skin breakdown, but who was observed by the State agency surveyor to have been delivered inadequate care, i.e., the pressure-relieving socks were not removed when foot care was given, only his toes were washed, and lotion was not applied to his feet. See generally HCFA Br., at 28-33.

30. Petitioner introduced proof to show that there is a proper method for one aide, working alone, to change a resident's incontinent pad. However, this proper method was not observed by the Michigan State agency surveyor on August 8, 1996. Moreover, there is no evidence that the nurse aide who performed the task improperly on August 8, 1996 cared for Resident 13 on only that single day, or that all other nurse aides who may have also changed Resident 13's pads had performed the task correctly on all other days.

31. Petitioner also stated in Resident 9's care plan that she was to "maintain current ROM per quarterly review." HCFA Ex. 42, at 7. The August 1996 survey team also found no joint mobility evaluations since July 18, 1995. Tr. 275.

Petitioner has made some efforts to explain the missing quarterly measurements for Resident 9 and Resident 13 on the basis of some equivocal evidence concerning its voluntary discontinuation of a certain quarterly measurement form or the quarterly measurement process in general. I do not find this line of defense to be meritorious. Assuming that the statement "maintain current ROM per quarterly review" constitutes a goal, that goal should be placed into a resident's care plan (for the delivery of appropriate services) because it is responsive to that individual's needs. However, Petitioner's evidence and arguments suggest, instead, that Petitioner was improperly inserting goals into what should have been individualized care plans on the basis of what forms were available and what system-wide practices were in place for all residents at the time.

32. If this was Petitioner's understanding from the hearing, then the conclusion is based on Petitioner's apparent inability to refute HCFA's position with material facts or arguments during the hearing. However, I am considering in this Decision those arguments and citations to evidence presented by Petitioner for the first time in its post-hearing briefs.

33. During the October 1996 revisit survey, the Worth Agency provided an undated, pre-existing written policy containing the information that aides would not be permitted to work if they had not completed 12 hours of training within 90 days of their hire. HCFA Ex. 66, at 12.

34. The record shows that each survey team assigns sequential numbers to the residents they review, and the assigned numbers always begin with "1."

35. Initially, Petitioner argued that it had not been placed on notice of HCFA's position on the assessment issue for Resident 4 due to alleged defects in the testimony and written report (HCFA 2567L) provided by the Michigan State agency surveyor. Pet. Br., at 64. This argument has been rendered moot by the written arguments and citations to testimony contained in HCFA's Post-Hearing Brief. In its Post-Hearing Reply Brief, Petitioner has had the opportunity to address the merits of HCFA's position.

36. In its initial Post-Hearing Brief, Petitioner noted correctly that Resident 4's example was cited under Tag F272, which corresponds to the requirements contained in 42 C.F.R. § 483.20 for assessments to be comprehensive and accurate. Pet. Br., at 64. A separate citation, Tag F273, covers the timeliness and frequency of resident assessments. This distinction was made apparent by the portions of both parties' briefs which addressed the outcome of the first survey. For the second survey, HCFA did not use Tag F273, even though the arguments submitted in Petitioner's reply brief would create a contrary impression.

37. Petitioner is correct in noting that "[t]here is absolutely no indication that Resident #4's catheter was causing her pain or discomfort as speculated by Surveyor Slater . . ." Pet. Rep. Br., at 60-61. However, the absence os such evidence was caused by Petitioner's failure to evaluate the possible causes for the repeated removal of Resident 4's indwelling catheter. Petitioner's description of this resident as a "schizophrenic, very confused and paranoid at times" would suggest rather strongly that the possibility of pain or discomfort as causes should be considered carefully. Id., at 60.

38. For example, in apparent response to a Michigan State agency surveyor's observation that there was no strap securing the catheter tube to Resident 4's leg, one of Petitioner's witnesses testified that the staff had been taping Resident 4's catheter tubing to her leg band and pulling the blanket up so she could not see the tubing; but Resident 4 would pull the tape off nevertheless and always find the tubing. Pet. Br., at 69-70.

I find interesting the similarities between Resident 4's situation and that of Resident 9, another individual whose records were used by HCFA to show Petitioner's failure to comply substantially with the care plan requirements during the second survey. Resident 9's care plan also contained a generalized statement that staff should provide "Foley cath[eter] care q [i.e., every] shift." Pet. Ex. 47. During October 1996, a different State agency surveyor observed that the catheter tube was not secured to Resident 9's leg to prevent its accidental removal. Tr. 482. This State agency surveyor described damage to the resident's urethral tissue as the potential harm. Id. In response to the State agency surveyor's observation that Resident 9's catheter had not been secured, Petitioner's witnesses did not testify that securing the tube was a part of the catheter care its staff was supposed to provide every shift. Therefore, HCFA noted the absence of such testimony by Petitioner's witnesses to support the conclusion that Resident 9's unsecured catheter tube, together with the care plan failure to provide specific information about the Foley catheter care he was to receive each shift, had placed this resident at risk for sustaining damages to urethral tissues if his catheter were to be pulled out accidentally. HCFA Br., at 78-79. It was only then that Petitioner attempted to create the impression that such testimony by its own witness was unnecessary because even the State agency surveyor was of the opinion that taping the catheter tube to a resident's leg or skin was "a standard of practice." Pet. Rep. Br., at 62.

There are major flaws with Petitioner's argument. First, there is insufficient credible evidence to support Petitioner's intimation that the aides delivering the actual Foley catheter care to Resident 9 on each shift knew, as the R.N. surveyor did, that securing the catheter tube was a "standard of practice." Neither HCFA nor the surveyors had found that Petitioner's aides were following the appropriate "standard of practice" in their delivery of care to residents. Moreover, this argument by Petitioner does not account for the fact that, even if the nurse aides understood the care plan's instructions for "Foley cath care q shift" to mean securing the tube to Resident 9's leg as a "standard of practice," the tube was not so secured when the surveyor made her observations of this resident.

39. In their post-hearing briefs, both parties pointed out that INR means "international normalized ratio," a standardized measure of blood coagulation. The lab tests required by the physician for Resident 10 are generally ordered to ascertain the effectiveness of the medication Coumadin. Tr. 424.

40. The "upper" CMP range is $3,050 to $10,000 per day. 42 C.F.R. § 488.438(a)(1).

41. The acronym "OSCAR" refers to the HCFA Online Survey Certification and Reporting System, and includes information related to a facility's noncompliance.

42. My 1998 Rulings did not address the 1994 survey results because they were not discussed by the parties. However, based on the arguments HCFA has presented in its post-hearing briefs, I would apply my analysis and conclusions for the October 1995 results to the 1994 results as well.

43. The parties did not provide much information about the 1994 survey results, other than that citations were issued under what appear to be superseded regulations. HCFA did not contend that Petitioner had any right to contest or appeal the validity of the 1994 citations.

44. It is entirely proper for HCFA to create such an opportunity. The interests of nursing home residents may be better served when those facilities HCFA considers to be out of compliance are encouraged to take the more pragmatic course. However, the interests of residents may be harmed if a facility's use of the opportunity made available by HCFA is then deemed an admission of noncompliance in future litigation. Such an interpretation will likely cause facilities to pursue a more contentious course of action in order to protect their legal positions.

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