DATE: July 14, 1998
In the Case of:
Cross Creek Health Care Center,
Petitioner,
- v. -
Health Care Financing Administration.
Civil Remedies CR504
App. Div. Docket No. A-98-35
Decision No. 1665
The Health Care Financing Administration (HCFA) and the Cross Creek Health Care Center (Petitioner) appealed a November 18, 1997 decision by Administrative Law Judge (ALJ) Steven T. Kessel. Cross Creek Health Care Center, DAB CR504 (1997) (ALJ Decision). Petitioner had sought a hearing before the ALJ challenging HCFA's imposition, pursuant to sections 1819 and 1919 of the Social Security Act (Act), of a civil money penalty for Petitioner's failure to comply substantially with requirements for participation in Medicare and Medicaid. HCFA found that Petitioner's failure to comply substantially with 42 C.F.R. . 483.13(a)--which provides that residents of a long-term care facility have a right to be free from restraints unless a restraint is necessary to treat medical symptoms--was widespread and posed immediate jeopardy to Petitioner's residents. HCFA also found that Petitioner's failure to comply substantially with numerous other participation requirements caused actual harm or posed a potential for more than minimal harm. See HCFA Ex. 5. Based on these findings, HCFA imposed a $7,500 per day civil money penalty beginning July 21, 1995 (the date of completion of the survey in which these findings were made) until August 18, 1995 (the date of the resurvey which found Petitioner's deficiencies no longer posed immediate jeopardy) and a $2,000 per day civil money penalty from August 19 until September 8, 1995 (the date of the resurvey which found Petitioner to be in substantial compliance).
In his decision, the ALJ reversed all but two of HCFA's findings of deficiencies involving the use of restraints. As to these two remaining deficiencies, the ALJ reversed HCFA's severity determination of immediate jeopardy and concluded that HCFA therefore had no authority to impose a $7,500 per day civil money penalty. Further, the ALJ upheld many of HCFA's deficiency findings relating to other participation requirements and concluded that these deficiencies placed Petitioner's residents at risk for more than minimal harm. Based on the applicable regulatory factors, the ALJ concluded that a $1,000 per day civil money penalty was reasonable.
On appeal, HCFA raised nine exceptions to the ALJ Decision and Petitioner raised two exceptions.
Our standard for review of an ALJ decision on a disputed issue of law is whether the ALJ decision is erroneous. Our standard for review on a disputed issue of fact is whether the ALJ decision as to that fact is supported by substantial evidence on the record as a whole. As discussed below, except for one technical modification, we uphold each and every one of the ALJ's findings of fact and conclusions of law (FFCLs). While we also modify or reverse certain underlying findings or conclusions in the ALJ's analysis, these changes do not require any substantive modification in the wording of the ALJ's FFCLs, nor do they require us to modify the civil money penalty imposed by the ALJ.
I. Procedural Background
Civil money penalties are one of a number of remedies implemented in 42 C.F.R. Part 483 that may be available when a facility is found not to comply substantially with the conditions of participation in Medicare and Medicaid. Long-term care facilities, such as Petitioner, are surveyed at least every 15 months to determine compliance with the requirements. Sections 488.20(a) and 488.308(a). A long-term care facility must be surveyed more often if necessary to ensure that identified deficiencies are corrected. Section 488.308(c). Based on the survey, the surveyors prepare a report (referred to as a Statement of Deficiencies or the HCFA 2567) that lists the deficiencies found, the regulations to which they relate, the surveyors' findings as to the scope and severity of the deficiencies, and the specific findings that support each deficiency determination. The severity categories range from deficiencies that cause "no actual harm with a potential for minimal harm" to ones that pose "immediate jeopardy to resident health or safety." Section 488.404(b)(1). The scope can be "isolated," "pattern," or "widespread." Section 488.404(b)(2).
Where a deficiency is found to be isolated and involve no actual harm with a potential for minimal harm, the facility is deemed to be in substantial compliance, and no action may be taken against it. Sections 488.301 (definition of "Substantial compliance"), 488.402(d)(2) and 488.408(f)(2). However, where there is a deficiency of any other scope and severity, the facility must submit a plan of correction which describes "1. How corrective action will be accomplished for those residents found to have been affected by the deficient practice; 2. How the facility will identify other residents having the potential to be affected by the same deficient practice; 3. What measures will be put into place or systemic changes made to ensure that the deficient practice will not recur; and 4. How the facility will monitor its corrective actions to ensure the deficient practice is being corrected and will not recur, i.e., what program will be put into place to monitor the continued effectiveness of the systemic changes." State Operations Manual, section 7304; see also sections 488.401 (definition of "Plan of correction"), 488.402(d) and 488.408(f)(1). Even if the plan of correction is accepted, the facility is not regarded as in substantial compliance until HCFA determines, usually through a revisit survey, that the deficiency no longer exists. Section 488.440(b) and (h).
For deficiencies of a certain scope and severity, HCFA may impose a civil money penalty, which may start accruing as early as the date that the facility was first out of compliance and continues until the date the facility achieves substantial compliance. Sections 488.408 and 488.440(a) and (b). A civil money penalty in the $3,050 to $10,000 range must be imposed where a deficiency poses immediate jeopardy, regardless of its scope. Section 488.408(e)(2)(iii) and (d)(3)(ii). Absent immediate jeopardy, a civil money penalty in the $50 to $3,000 range must be imposed where a widespread deficiency causes no actual harm with a potential for harm that is more than minimal or where a deficiency of any scope causes actual harm. Section 488.408(d)(2). A civil money penalty in the same range may be imposed based on any other deficiency except where the facility is in substantial compliance. Section 488.408(d)(3).
HCFA determined that Petitioner failed to comply substantially with the federal requirements for participation in Medicare and Medicaid based on a survey of Petitioner conducted on behalf of HCFA by the Florida Agency for Health Care Administration (State survey agency) on July 17 through 21, 1995. The July survey consisted of an on-site visit to the facility during which the surveyors reviewed a sample of Petitioner's patient records and interviewed members of Petitioner's staff, residents, and relatives of residents. The report of the July 1995 survey identified 17 deficiencies in Petitioner's operation. These deficiencies are listed in the survey report under headings that are designated as "tags," each of which corresponds to a requirement of participation in the regulations. (For example, Tag 221 corresponds to the surveyors' finding of a deficiency involving physical restraints under section 483.13(a); Tag 222 corresponds to the surveyors' finding of deficiency involving chemical restraints, also under section 483.13(a).) Under each tag are the facts found by the surveyors and an explanation of those findings. Also included under each tag are the surveyors' findings of the scope and severity of each deficiency.
On August 8, 1995, Petitioner submitted a plan of correction to the Florida State survey agency. HCFA Ex. 5. While Petitioner did not admit that it had failed to comply substantially with participation requirements, it offered specific corrective actions to address each of the findings of noncompliance.
On August 18, 1995, the surveyors returned to Petitioner. At this time, the surveyors did not attempt to determine anything other than whether the immediate jeopardy circumstances identified in the July survey continued to exist. They determined that residents were no longer in immediate jeopardy.
On September 8, 1995, Petitioner was resurveyed. At this time, the surveyors determined that Petitioner had corrected all outstanding deficiencies and was in substantial compliance with the participation requirements.
Pursuant to the findings in these surveys, HCFA imposed a $7,500 per day civil money penalty from July 21 through August 18, 1995; and a $2,000 per day civil money penalty between August 19 through September 8, 1995.
II. The Parties' Exceptions
A. HCFA's Exceptions
HCFA filed the following exceptions:
HCFA did not identify the FFCLs to which it was taking exception. Therefore, we surmise that HCFA intended to appeal the FFCLs 2, 3.b, 4, 4.a, 4.b, 5, 6, 7, 9, and 12. We set out the text of those FFCLs and discuss them in the analysis section of our decision.
B. Petitioner's Exceptions
Petitioner excepted to the ALJ's finding that the scope of the chemical restraint deficiency was "widespread." Petitioner excepted to the ALJ's finding which sustained the surveyors' findings under Tag 314 involving pressure sores. These exceptions involve findings made under FFCL 12.
Neither party appealed FFCLs 1, 3, 3.a., 8, 10, and 11. Accordingly, we sustain those five FFCLs without further discussion. We sustain the remaining FFCLs in the discussion that follows. In that discussion, we make a technical correction to the language of FFCL 2 and reverse certain of the ALJ's underlying conclusions which were not articulated in his numbered FFCLs. As we stated previously, our reversal of these underlying conclusions does not require us to modify the penalty amount, which remains amply supported in the record.
III. Analysis
A. Analysis of HCFA's Exceptions
The majority of HCFA's allegations of error concerned the ALJ's findings and conclusions concerning the use of restraints. Below we discuss the regulation concerning the use of restraints by nursing facilities, the ALJ Decision, and each of HCFA's exceptions.
Use of physical and chemical restraints by a long-term care facility is governed by sections 1819(c)(1)(A)(ii) and 1919(c)(1)(A)(ii) of Act. HCFA implemented these provisions by adopting 42 C.F.R. . 483.13(a), which provides:
The resident has the right to be free from any physical or chemical restraints imposed for purposes of discipline or convenience, and not required to treat the resident's medical symptoms.
The restrictions on use of restraints are an important component of Medicare and Medicaid's goal of ensuring that nursing facilities provide "services to attain or maintain the highest practicable physical, mental, and psychosocial well-being of each resident." Section 1819(b)(2) of the Act. The use of restraints is associated with numerous negative outcomes, such as emotional desolation, agitation, fractures, chafing, burns, nerve damage, circulatory impairment, decubitus ulcers, strangulation and death. See 57 Fed. Reg. 27,397, 27,398 (June 19, 1992). Consequently, the Act and the regulation seek to prevent restraints from being used if they are not medically necessary. These values are reflected in the Physical Restraint Resident Assessment Protocol (RAP), found in Chapter 10, Appendix R of HCFA's State Operations Manual, which is to be used in the comprehensive assessment process mandated by section 1819(b)(3) of the Act. The Physical Restraint RAP states that, because of the detrimental consequences of restraints, "the goal of minimizing or eliminating restraint use has become central to both clinical practice and federal law."
The ALJ sustained only one of the surveyors' findings of restraint deficiencies. That deficiency had to do with the use of a chemical restraint. As to the other restraint deficiencies, the ALJ found that the restraints were required to treat medical symptoms and were not imposed for discipline or convenience. The ALJ based his findings on the following considerations. He found that HCFA had "failed largely" to establish a prima facie case that the physical restraints were improperly applied because HCFA's evidence consisted of the testimony of surveyors (a nutritionist and a social worker) who he found were not competent to testify that a restraint was medically unnecessary. ALJ Decision at 22. He also found that Petitioner rebutted, with expert testimony and documentary evidence, "any prima facie evidence of noncompliance introduced by HCFA." Id. Further, the ALJ found that HCFA had not established even a prima facie case as to the misuse of the one remaining chemical restraint. Id. at 32.
1. The ALJ did not err in excluding consideration of whether the disputed restraints were subject to a systematic process of evaluation as described in the Interpretive Guidelines to Surveyors.
HCFA took exception to the following FFCL 2 which provides:
2. HCFA did not give Petitioner timely notice of its assertions that: Petitioner was obligated to perform comprehensive assessments of its residents to determine the residents' need for restraints; and Petitioner failed to perform comprehensive assessments.
ALJ Decision at 13.
Pursuant to his finding, the ALJ declined to consider HCFA's argument that, because Petitioner did not have a systematic process for restraint evaluation, Petitioner's use of restraints violated the restraint regulation. HCFA argued that "the ALJ erred in excluding evidence based upon his own objection that the facility was unaware of the evaluation requirement attendant to the regulatory limitation on the use of restraints, as expressed in the Interpretive Guidelines." HCFA Br. at 12.
The Interpretive Guidelines to which HCFA referred are part of HCFA's State Operations Manual, a publication which is distributed to state survey agencies to assist them in conducting facility surveys. The Guidelines, like the Statement of Deficiencies, are organized by tags, each of which corresponds to a requirement of participation in the regulations. The Guidelines for section 483.13(a) reiterate the cautions on the use of restraints found in the Physical Restraints RAP and direct surveyors to consider whether facilities maintain a "systematic process" for the initial and continuing evaluation of the use of restraints. In the post hearing briefing process, HCFA argued that the absence of a systematic process as set forth in the Guidelines meant that Petitioner had not complied with the requirements for the use of restraints.
The ALJ declined to allow HCFA to rely on the systematic process argument because he found that HCFA had not given Petitioner sufficient notice, prior to the hearing, of this interpretation of the grounds for the deficiency. For the following reasons, we conclude that the ALJ was correct in excluding consideration of the question of whether Petitioner had engaged in a systematic process as set forth in the Guidelines.
First, neither the Statement of Deficiencies nor any other correspondence prior to the hearing informed Petitioner that a basis for a deficiency finding was Petitioner's failure to have a systematic process for evaluating restraints. Rather, the language in the Statement of Deficiencies is more fairly read to have apprised Petitioner that the issue was whether a given restraint was medically necessary. Further, the Statement did not cite the Guidelines or mention the words "systematic process."
Second, while the Guidelines were included in HCFA's exhibits filed prior to the hearing, there were numerous other exhibits and HCFA made no specific reference to the systematic process provision in the restraint section of the Guidelines.
Third, at the hearing, the testimony presented by HCFA relating to the evaluation of the restraints was a very small part of the proceeding. The testimony on restraints concentrated on the surveyors' and facility nurses' observations of the residents' conditions or behaviors in relation to the use of restraints. Neither the HCFA witnesses nor counsel ever referred to the fact that the Guidelines set forth reviewing standards for restraints, or to the restraint evaluation questions set forth in the Guidelines, or even to the term "systematic process." A reader of the transcript would never guess that the cornerstone of HCFA's case was the absence of a systematic process as outlined in the Guidelines. Only in its post-hearing briefing did HCFA begin expressly to cite the provisions in the Guidelines concerning the use of a systematic process of evaluation. HCFA, at that point, began arguing that absence of the process meant that the facility could not be in substantial compliance. HCFA wrote:
The Guidelines make explicit that a facility cannot meet its burden of proving compliance with the restraints requirements of participation unless it has engaged in a systematic process of evaluation and care planning that addresses certain identified issues . . .HCFA Post Hearing Brief at 15.
The test of whether a facility has met . . . its obligation [under 42 C.F.R. . 483.13(a)] is whether the facility has used a systematic process of evaluation that addresses the issues discussed in the Interpretive Guidelines.
HCFA Post Hearing Reply Brief at 4.
Petitioner's Post Hearing Brief did not mention the Guidelines. Rather, it focused on the facts about each resident. This is understandable since, up to that point, HCFA had not cited the systematic process standards set forth in the Guidelines. In its Post Hearing Reply Brief, after receiving notice that the Guidelines were at issue, Petitioner began to object to HCFA's reliance on them.
The Board has previously addressed questions of notice and burden of proof in cases in which HCFA has determined that a provider is not in substantial compliance with Medicare/Medicaid conditions of participation. In Hillman Rehabilitation Center, DAB 1611, at 11 (1997), the Board stated that, as part of its burden of coming forward in such a case, "HCFA must identify the legal criteria to which it seeks to hold a provider." Since that decision also placed the ultimate burden of proof on providers, fairness dictates that facilities be apprised, prior to the hearing, of the basis for HCFA's decision, including the legal criteria and the facts. (Later in this decision we discuss the standards of proof set forth in Hillman and their applicability to civil money penalty cases.) Without such information, a facility cannot prepare properly for the hearing. In this case, HCFA did not apprise Petitioner that HCFA viewed the failure to adopt a systematic process as described in the Guidelines as a deficiency under section 483.13(a) until after the hearing, and the ALJ was correct to exclude consideration of this issue.
Accordingly, we sustain FFCL 2. Although we do not accept HCFA's arguments in opposition to FFCL 2, we make the following technical modification so that it will reflect the relevant language in the Guidelines rather than use the term "comprehensive assessment."
2. HCFA did not give Petitioner timely notice of its assertions that: Petitioner was obligated to follow a systematic process as outlined in the Guidelines to Surveyors to evaluate residents' need for restraints; and Petitioner failed to follow such a systematic process.
2. The ALJ did not err in concluding that a physician's order that a restraint be applied to a resident may be persuasive evidence that the restraint is being applied for reasons that are medically necessary.
HCFA took exception to the following finding by the ALJ:
3.b. A physician's order that a restraint be applied to a resident may be persuasive evidence that the restraint is being applied for reasons that are medically necessary.
In discussing this finding, the ALJ stated that a doctor's order for a restraint "embodies an expert opinion that the restraint is medically necessary." ALJ Decision at 17.
HCFA argued that the ALJ erred in finding that a doctor's order authorizing the use of restraints on a resident was evidence the facility had complied with its obligations for the use of restraints on that resident. HCFA asserted that a long-term care facility had an obligation to make an independent assessment of whether a restraint was required and to discuss with a doctor any restraint order that it considered unnecessary. HCFA relied on the preamble to the regulations, which provides that a long-term care facility cannot simply rely on doctor's order when assessing compliance. Rather, ". . . it is the facility's responsibility to ensure that the services provided by physicians will satisfy the facility's obligations under the Act and regulations." HCFA Br. at 27-30, citing 59 Fed. Reg. 56116, 56227 (Nov. 10, 1994).
We sustain FFCL 3.b. A doctor is a medical professional whose training qualifies him or her to assess a resident's medical symptoms and the need for restraints. A doctor's order, while not conclusive, may be persuasive evidence on medical necessity, as the ALJ concluded.
However, while we sustain this FFCL, we believe that the ALJ's discussion of this issue failed to adequately recognize the facility's responsibility to make an independent determination as to whether a restraint ordered by a doctor meets the standards set forth in section 483.13(a). That regulation imposes on nursing facilities, not doctors, an obligation to use restraints in a very prescribed manner -- not for discipline, not for convenience and only if required by the resident's medical symptoms. Further, nursing facilities are subject to other Medicare/Medicaid requirements which are also not applicable to doctors and which could impact on a decision under section 483.13(a) to use or not use restraints. For example, a long-term care facility is required to consult with the resident or the resident's surrogate about all treatment decisions (42 C.F.R. . 483.10(d)(2)); a long-term care facility is required to help a resident achieve his/her highest practicable physical, mental and psychosocial well-being (section 1819(b)(2)); and a long-term care facility resident has a right to refuse medical treatment (42 C.F.R. 483.10(b)(4)).
Because section 483.13(a) is directed towards nursing facilities, the regulation imposes on the long-term care facility an independent obligation to ensure that the use of restraints, even with a doctor's order, meets the criteria of the regulation. Further, it imposes an independent obligation to continue to assess the impact of the use of a restraint and to consult with the doctor if the nursing facility finds that use of the restraint no longer meets the criteria of the regulation. Finally, review of a facility's compliance requires careful consideration to make sure that the facility is implementing the doctor's restraint order pursuant to its terms. Therefore, a long-term care facility cannot rely solely on a doctor's order to prove compliance with section 483.13(a) and must be able to show with other evidence as appropriate that the specific restraints applied were not imposed for discipline or convenience and were necessary to treat a medical symptom.
3. The ALJ applied the burden of proof properly and did not interpret the restraint regulation so as to require HCFA to prove noncompliance rather than Petitioner to prove compliance.
In Hillman, the Board addressed the sequence of proof as to disputed issues of fact in provider termination cases. In FFCLs 1A, 1B, 1C, and 1D, it held --
. . . HCFA must set forth the basis for its determination terminating a provider with sufficient specificity for the provider to respond, including the basis for any finding that a condition-level deficiency exists. The provider must then identify which of the findings material to the determination the provider disputes, and must also identify any additional facts the provider is asserting.
. . . At the hearing, HCFA has the burden of coming forward with evidence related to disputed findings that is sufficient (together with any undisputed findings and relevant legal authority) to establish a prima facie case that HCFA had a legally sufficient basis for termination.
. . . At the hearing, the provider has the burden of coming forward with evidence sufficient to establish the elements of any affirmative argument or defense which it offers.
. . . The provider bears the ultimate burden of persuasion. To prevail, the provider must prove by a preponderance of the evidence on the record as a whole that it is in substantial compliance with the relevant statutory and regulatory provisions.
In this case, the ALJ concluded that the holding in Hillman also applied to civil money penalty remedies imposed by HCFA on long-term care facilities. However, HCFA asserted that the ALJ misinterpreted the regulation and manipulated the concept of prima facie case. HCFA argued that the ALJ thereby effectively shifted the burden of proof from Petitioner and required HCFA to prove noncompliance. HCFA stated:
4. The opinions which Florida State survey agency surveyors offered as to whether Petitioner applied restraints for medically necessary reasons are largely unfounded and, therefore, are not competent or credible evidence that Petitioner applied restraints improperly.
4.a. HCFA did not establish that Ms. Gonzalez is competent to render expert medical opinions as to medical issues.
4.b. HCFA did not establish that Ms. Faulkner is competent to render expert medical opinions as to medical issues.
5. The assertions made under tag 221 in the report of the July 17-21, 1995 survey that Petitioner did not apply physical restraints to Residents 3, 8, and 18 for a proper purpose, thereby placing the residents in immediate jeopardy, either are unsubstantiated or are rebutted by the preponderance of the evidence.
We note, however, that HCFA may have legitimate concern caused by the ALJ's statement that, as part of its prima facie case, HCFA must provide evidence of an improper purpose. In our view, HCFA need only provide evidence that the facility lacks any documentation of medical necessity (such as a required physician order) or credible evidence of improper purpose (such as a statement by staff that suggests the restraint is imposed for convenience) in order to shift the burden to Petitioner to show compliance by a preponderance of the evidence.
4. The ALJ did not err in his treatment of the surveyors' testimony in relation to the doctors' orders for restraints.
HCFA argued that the ALJ erred in determining that the surveyors were "second-guessing" the propriety of the doctors' orders for restraints on certain residents. HCFA argued that the issue was not "second guessing" the physician judgments but "whether the nursing facility applied a systematic process of evaluation." (HCFA Br. at 31). HCFA then went on to explain why the process of establishing such individualized care programs is important and central to the entitlement to Medicare reimbursement. HCFA asserted:
It is not the surveyors who make a medical judgement about the use of restraints which then must be proven correct in an appeal such as this, as Petitioner argues. Rather, it is the facility's burden to prove compliance with the regulatory requirement that restraints be used only when necessary to treat medical symptoms. The test of whether a facility has met this obligation is whether the facility has used a systematic process of evaluation that addresses the issues discussed in the interpretive Guidelines. In the absence of such an evaluation, as occurred here with Petitioner, the facility has not established that the restraints are required. HCFA Br. at 33.
We reject this allegation of error because it rests on the assumption that Petitioner's restraint evaluation process was determinative of whether Petitioner complied with the regulation. Since we have found that HCFA cannot use process as a factor in assessing compliance in this case, this argument is without merit. The only issue related to the surveyors' testimony was whether the restraints were medically necessary. Absent evidence of the surveyors' medical training or experience, the ALJ properly found that they were not qualified to speak to this issue.
5. The ALJ did not err in his treatment of symptoms of combative behavior and hostility.
HCFA argued that the ALJ erred in finding that the symptoms of combative behavior and hostility were evidence that the facility had met its obligations under the regulatory limitation on the use of restraints. HCFA asserted that the fact a resident is angry or combative simply confirms that the resident --
is in the group at risk for the improper use of restraints. As the Guidelines point out all of these behaviors are at best ambiguous indicators of a resident's need for a restraint. The evidence of compliance with the restraint requirement is evidence of evaluation of those behaviors to determine the nature of the medical problem that gave rise to the behavior and to determine what would be the least restrictive intervention to treat the cause of those behaviors. HCFA Br. at 27.
The ALJ did not err in considering the fact that one of the restrained residents engaged in combative and hostile behavior. These are medical symptoms which are relevant to determining whether restraints are medically necessary. Further, the record indicates that this resident had been recently admitted from a hospital where he had also been restrained, that his restraints were reviewed by Petitioner's restraint committee, and that a decision was made to continue restraining him.
6. While the ALJ has the authority to review the "scope" of a deficiency in certain circumstances, his decision to modify the chemical restraint deficiency scope from "isolated" to "widespread" was error.
The surveyors determined that the chemical restraint deficiency was isolated. The ALJ determined chemical restraint deficiency was widespread. He also went on to agree with the surveyors that the administration deficiency was widespread.
HCFA noted that, pursuant to 42 C.F.R. . 498.3(b)(13), an ALJ is entitled to review HCFA's findings on levels of compliance "only if a successful challenge on this issue would affect the range of the civil money penalty amounts that HCFA could collect." Since the scope of the chemical restraint and administration deficiencies does not affect the range of the civil money penalty which HCFA may impose, HCFA asserted the ALJ erred when he addressed the scope of the chemical restraint deficiency. As explained below, we conclude that, while section 498.3(b)(13) does not preclude an ALJ from addressing scope if the ALJ modifies deficiency findings, it does preclude the ALJ from expanding HCFA's determination of scope.
The Board addressed an ALJ's authority to review HCFA's determination of scope in Lake City Extended Care Center, DAB 1658 (1998). In that case, the original determination of widespread scope was based on the surveyors' finding that there were numerous incidents that violated the standard of care. The Board determined that the ALJ properly found that the standard of care was violated in only one of the alleged incidents. The Board further determined that the regulation does not preclude the ALJ from making a new finding as to the scope of the deficiency where the ALJ's findings as to the deficiencies are different from the surveyors' findings. However, where an ALJ makes no adjustment to the surveyors' findings, the ALJ cannot redetermine scope under section 489.3(b)(13). That provision commits the scope
determination in cases where it does not affect the range of the penalty to HCFA's discretion, unless it is necessary for the ALJ to review scope because he did not uphold all of the surveyors' findings.
Therefore, where, as here, the ALJ does not uphold all of the surveyors' findings, his review is necessarily limited to whether the scope should be a lesser level rather than a higher level. Otherwise, the ALJ would be substituting his judgment for a determination that is committed to HCFA's discretion. Accordingly, having actually reduced the number of incidents on which this deficiency rested, the ALJ erred in then expanding its scope. Indeed, even if the ALJ had upheld all of HCFA's deficiency findings as to chemical restraints, he could not expand HCFA's determination of scope.
We do not modify any numbered FFCL since the ALJ's redetermination of the scope in this case was without consequence to the outcome and not reflected in any FFCL.
7. The ALJ properly applied the "clearly erroneous" standard, not the "preponderance of the evidence" standard, when reviewing HCFA's determination of the immediate jeopardy severity of the restraint and administration deficiencies.
The ALJ upheld one of the surveyors' two findings as to the misuse of chemical restraints. He also upheld the administration deficiency, which was a derivative deficiency based on the surveyors' findings of other deficiencies. The surveyors determined that the chemical restraint deficiency and the administration deficiency posed immediate jeopardy to resident health. The ALJ reversed the immediate jeopardy determination. HCFA argued that the ALJ did not review the immediate jeopardy finding under the clearly erroneous standard as required by
42 C.F.R. . 498.60(c)(2). Since the ALJ's finding specifically states that HCFA's determination of immediate jeopardy is clearly erroneous (ALJ Decision at 30, FFCL 6), we assume HCFA is actually arguing that its determination of immediate jeopardy was not clearly erroneous.
On appeal, the only evidence HCFA cited concerning the level of harm resulting from the one chemical restraint deficiency at issue consisted of the material from the Guidelines. HCFA argued:
In regard to chemical restraints the Interpretive Guidelines describe the deleterious effects and diminishment of functioning that accompany the use of restraints. Where as here the ALJ upheld a finding that chemical restraints were being unnecessarily applied, it cannot be said, taking into account the findings recorded in the Interpretive Guidelines that, a finding of immediate jeopardy to resident health and safety was clearly erroneous. HCFA Br. at 41 - 42.
However, the ALJ chose to rely on the testimonial evidence in the record. He found that, even though HCFA called a nurse who was competent to testify about harm, "HCFA offered no evidence to show that the resident was either harmed, or even potentially harmed, by the improper administration of Ativan." ALJ Decision at 33. The ALJ further noted that it was Petitioner who asked this nurse, on cross examination, about possible effects, and she replied that this resident experienced no harm from the administration of Ativan. Given the testimonial evidence in the record from HCFA's own witness, we find that the ALJ's conclusion that HCFA's finding of immediate jeopardy was clearly erroneous is supported by substantial evidence.
Accordingly, we sustain FFCLs 6, 7 and 9, which provide:
6. The assertions made under tag 222 in the report of the July 17-21, 1995 survey that Petitioner did not apply chemical restraints to Residents 8 and 29 for a proper purpose, thereby placing the residents in immediate jeopardy, either are unsubstantiated or are clearly erroneous.
7. The assertions made under tag 490 in the report of the July 17-21, 1995 survey that Petitioner was not administered effectively, thereby placing Petitioner's residents in immediate jeopardy, either are unsubstantiated or are clearly erroneous.
9. HCFA did not establish a basis for imposing an upper range civil money penalty against Petitioner of from $3,050 -$10,000 per day.
8. The ALJ erred in treating the civil money penalty as being imposed solely for the immediate jeopardy deficiencies rather than for the facility's failure to be in substantial compliance with program requirements.
The ALJ stated that HCFA imposed the civil money penalty based on its determination that Petitioner had failed to comply with the restraints requirements and with the effective administration requirement. He further stated that --
[t]he additional 14 findings of deficiencies made by the surveyors at the July 17 - 21, 1995 survey of Petitioner were not the basis for HCFA's determination to impose a civil money penalty against Petitioner, but were relied on by HCFA as ancillary evidence of noncompliance .ALJ Decision at 35.
HCFA protested that it had based its decision to impose a civil money penalty on its findings that Petitioner was not in substantial compliance. HCFA argued that this is the first step in the imposition of a civil money penalty, while the second step concerns the determination of the range of the civil money penalty. HCFA wrote:
This step [the second step] first involves a determination whether the upper range of CMP's . . . or the lower range . . . should be used. These ranges do not denote two different CMP's, as the ALJ here seems to believe, but rather two different ranges for determining the amount of the CMP. Since the most severe deficiency found in a survey is used to determine the proper range, it is accurate to refer to the most serious deficiency as the determinative one. However, it is determinative only as to range and not as to the basis for the CMP.
The Board dealt with this question in Lake City. In that case, the ALJ found that he did not have authority to impose a lower range civil money penalty because HCFA had based its upper range civil money penalty only on the immediate jeopardy deficiencies. The Board found that HCFA's civil money penalty was based on all the identified deficiencies. We conclude that, as in Lake City, HCFA in this case based its civil money penalty on all the deficiencies. In its letter notifying Petitioner of the civil money penalty, HCFA stated "[t]his civil monetary penalty is based on the facility's failure to comply with the requirements for nursing home participation in Medicare and Medicaid programs at 42 C.F.R. . 483.1 et seq., as reflected in the Statement of Deficiencies attached to our August 4, 1995 letter." HCFA Ex. 3, at 1. As the Board has previously noted, there is no requirement that HCFA spell out in its notice letter all the findings on which it relies. See Desert Hospital, DAB 1623, at 10, n. 9 (1997). Moreover, the regulations clearly contemplate that a civil money penalty may be imposed based on multiple deficiencies as was the case here. Section 488.402(c) provides that "HCFA . . . may apply one or more remedies for each deficiency constituting noncompliance or for all deficiencies constituting noncompliance." In explaining this provision, the preamble to the final regulations states that "it may also be appropriate for one remedy to be imposed for multiple deficiencies that constitute noncompliance . . . ." 59 Fed. Reg. 56,116; 56,168. In addition, section 488.430(a) provides that "HCFA . . . may impose a civil money penalty for the number of days a facility is not in substantial compliance with one or more participation requirements . . . ."
Therefore, we reverse the ALJ's unnumbered finding that the civil money penalty was based only on the deficiencies involving immediate jeopardy. We do not modify any numbered FFCL since the ALJ's characterization of the process in this case was without consequence to the outcome and not reflected in a numbered FFCL.
9. Except for a finding as to one resident, the ALJ's findings were supported by substantial evidence in the record.
In addition to the deficiencies which the surveyors found to pose immediate jeopardy, the surveyors listed numerous other deficiencies. The ALJ sustained some and reversed others of these findings. HCFA argued that the ALJ made numerous errors of fact in reversing these findings.
We have carefully reviewed the record with respect to all the factual findings challenged by HCFA, including all of the evidence on which HCFA relied in support of its position. Except as to one finding under Tag 441, we conclude that there is substantial evidence in the record as a whole that supports the ALJ's findings and reversal of those findings is not warranted. The erroneous finding at issue is discussed below.
Tag 441 is based on 42 C.F.R. . 483.65(a), which requires that facilities establish infection control programs, decide what techniques to use for individual residents, and maintain records of incidents and corrective actions related to infections. Under Tag 441, the surveyors alleged that Petitioner utilized poor infection control techniques in its handling of residents' linens, and in its general adherence to aseptic techniques.
Except for the finding related to Resident 28, the ALJ upheld the surveyors' findings under this tag. As to Resident 28, the surveyors alleged that Petitioner did not implement infection control procedures after he developed a very infectious and resistant infection. Citing Petitioner's Exhibit 1, at 400-411, the ALJ concluded that infection control procedures had been instituted. HCFA argued that these pages consisted only of the laboratory report confirming the infection and portions of the Beverly Infection Control Program Manual. We find that HCFA is correct; the record is devoid of any contemporaneous record which would support a finding that the procedures in the Infection Control Program Manual were instituted as to this resident. Therefore, there was no substantial evidence to support a finding that Petitioner had used appropriate infection control techniques for Resident 28. While we modify an underlying finding of the ALJ not specifically addressed in any of his FFCLs, the modification is not significant enough to require us to reassess the amount or duration of the civil money penalty imposed by the ALJ.
Accordingly, we sustain FFCL 12 which provides:
12. A civil money penalty of $1,000 per day for each day that Petitioner was not complying substantially with participation requirements is reasonable.
B. Analysis of Petitioner's Exceptions
1. The ALJ erred in determining that the scope of the administration deficiency was "widespread."
Petitioner argued that the ALJ erred in redetermining the scope of the chemical restraint deficiency to be "widespread" and in sustaining the determination that the administration deficiency was "widespread."
In the prior section, we determined that the ALJ acted beyond his authority in expanding the scope of the chemical restraint deficiency from isolated to widespread. This obviates the need to consider Petitioner's arguments concerning the merits of a scope determination on the chemical restraint deficiency.
The remaining issue involves the scope of the administration deficiency. The administration deficiency was a derivative deficiency, i.e., it was based on HCFA's findings of other deficiencies. The surveyors determined that the administration deficiency was widespread. The ALJ agreed with HCFA that the administration deficiency was widespread.
Determination of scope is committed to HCFA's discretion unless it is necessary for the ALJ to review scope because he reversed surveyors' findings or the scope affects the range of the civil money penalty. In this case, the ALJ reversed many of the surveyors' findings underlying the administration deficiency. However, he did not reduce the scope determination for the administration deficiency because he erroneously found that the chemical restraint deficiency was widespread. Since we reversed that finding and since many of the other deficiency findings which supported the administration deficiency were reversed by the ALJ (including all of the deficiencies which were classified by HCFA as "widespread"), we conclude that the administration deficiency should be classified as a pattern. This result is consistent with an interpretation of "widespread" and "pattern" issued by HCFA's Office of Survey and Certification to Associate Regional Administrators and State Survey Agencies Directors and relied on by Petitioner. Petitioner Ex. A. In that memorandum, HCFA wrote:
"Widespread" is to be identified when a large number of residents in the facility have the potential to be affected and the survey team identifies the deficient practice as pervasive (i.e. throughout the facility). In addition, "widespread" scope may be identified if a systemic failure in the facility (e.g., failure to maintain food at safe temperatures) has affected or could affect a large number of residents across the facility and is therefore considered pervasive.
In this case, the deficiencies which were sustained by the ALJ did not have the potential to affect a large number of residents and the practices were not identified as pervasive.
Since the ALJ's determination on this point was not reflected in an FFCL, we do not modify any FFCL. We moreover do not modify the civil money penalty since the record still amply supports the amount and duration of the penalty imposed by the ALJ.
2. The ALJ's deficiency findings under Tag 314 (pressure sores) were supported by substantial evidence.
A long-term care facility's obligations concerning pressure sores are set forth in 42 C.F.R . 483.25(c). That regulation provides:
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; and
(2) a resident having pressure sores receives necessary treatment and services to promote healing, prevent infection and prevent new sores from developing.
The surveyors found that four of 29 sampled residents developed pressure sores under circumstances where there was no clinical condition manifested by any of these residents that demonstrated that the development of a pressure sore was unavoidable.
The ALJ sustained HCFA's findings. Petitioner objected on the following grounds:
In the cases of three of the four patients, the surveyors made no allegation that the pressure sores were unavoidable -- the concerns were about the relationship between the sores and the use of restraints. Therefore, according to Petitioner, the ALJ concluded there was a deficiency because Petitioner did not disprove something that was never alleged.
The surveyors who testified about the sores were considered by the ALJ as not competent to testify about the medical need for restraints. Therefore, they were also not competent to testify about whether pressure sores were avoidable.
At hearing, Petitioner demonstrated that the factual assertions in the Statement of Deficiencies were either erroneous, or did not relate to causation or treatment of pressure sores, and that each resident was given appropriate treatment.
We reject Petitioner's allegation of error for the following reasons.
First, Petitioner is mistaken in asserting that the surveyors failed to allege that the pressure sores were unavoidable. The introductory paragraph to the discussion of the four residents at issue in this Tag stated: "Record review and interview revealed that four of 29 sampled residents . . . developed pressure sores in the facility when there was no clinical condition demonstrating that they were unavoidable." It then goes on to discuss the four residents the survey team identified. This is a sufficient statement that the surveyors were alleging that these pressure sores were avoidable.
Second, since Petitioner did not deny that these residents had pressure sores, the surveyors' medical expertise to identify pressure sores is not at issue. The assumption inherent in the regulation is that a resident should not have pressure sores unless they are unavoidable. As the RAP for Pressure Ulcers states:
[Pressure ulcers] are one of the most common, preventable and treatable conditions among the elderly who have restricted mobility. Successful outcomes can be expected with preventive and treatment programs.
Therefore, as the ALJ determined, once surveyors identify a resident with pressure sores, it is incumbent on the long-term care facility to demonstrate that such sores were unavoidable.
Third, we have reviewed the record as to the specific facts of each resident and find that there is substantial evidence for the ALJ's determinations.
III. Conclusion
Except for a technical correction to FFCL 2, we uphold each and every one of the ALJ's findings of fact and conclusions of law. While we have modified or reversed certain underlying findings or conclusions in the ALJ's analysis, these changes do not require any substantive modification in the wording of the ALJ's FFCLs, nor do they require us to modify the civil money penalty imposed by the ALJ.
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Judith A. Ballard
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Cecilia Sparks Ford
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Donald F. Garrett
Presiding Board Member