DATE: December 3, 1997
Civil Remedies CR474
App. Div. Docket No. A-97-138
Decision No. 1638
In the Case of:
Oak Lawn Pavilion, Inc.,
Petitioner,
- v. -
Health Care Financing Administration
Oak Lawn Pavilion, Inc. ("Oak Lawn" or "Petitioner") appealed a May 21, 1997 decision by Administrative Law Judge Mimi Hwang Leahy. See Oak Lawn Pavilion, Inc., DAB CR474 (1997) ("ALJ Decision"). The ALJ Decision upheld the Health Care Financing Administration's ("HCFA's") termination of Oak Lawn's participation in the Medicare program as a skilled nursing facility. HCFA's decision was based on its finding that Oak Lawn was not in substantial compliance with federal Medicare requirements during two on-site surveys conducted by the Illinois Department of Public Health: one performed February 1-3, 1995 ("February survey") and one performed March 27 through April 3, 1995 ("April survey" or "resurvey").
For the reasons stated below, we uphold the ALJ Decision. We conclude that none of Oak Lawn's exceptions to the ALJ Decision has merit.
BACKGROUND
Medicare is a federally funded program of health insurance for the elderly and disabled under Section XVIII of the Social Security Act ("Act"). In order to participate in Medicare as a provider of health care services and to receive federal payments under the program, an entity must enter into an agreement with the Department of Health and Human Services. Section 1866 of the Act. Section 1819 of the Act contains the definition of a skilled nursing facility ("SNF") and the requirements for a provider to participate in the program as a SNF, providing long-term care to beneficiaries. These requirements address such matters as the provision of particular services, resident rights, facility administration, and the health, safety and well-being of residents. The criteria codified in Subpart B of Part 483 of Title 42 of the Code of Federal Regulations are the health and safety requirements promulgated by the Secretary of Health and Human Services for SNFs. A SNF may participate in Medicare only so long as it continues to meet these requirements. 42 C.F.R. . 483.1(b), 488.20, 489.10(a)(d) (1994).
In order to determine whether a SNF continues to meet the requirements for participation, HCFA conducts, or has a state survey agency under contract with HCFA conduct, periodic on-site visits to each facility. See section 1864(a) of the Act; 42 C.F.R. .. 488.10(a) and 488.20. The regulations require that each SNF be surveyed at least once every 12 months. A SNF must be surveyed more often if necessary to ensure that identified deficiencies are corrected. 42 C.F.R. . 488.20(a).
The Illinois Department of Public Health ("IDPH") conducted two surveys of Oak Lawn during early 1995. The February survey was a routine survey. The IDPH surveyors found five deficiencies of "Level A" requirements, which were, in turn, based on 37 findings of deficiencies of "Level B" requirements. Following the February survey, Oak Lawn was notified in writing of the February survey findings and told that IDPH would recommend that Oak Lawn's provider agreement be terminated if the facility did not achieve compliance by the time of a resurvey, to be scheduled approximately 45 days following the February survey. Oak Lawn submitted a plan of correction in which it agreed to correct each of the deficiencies no later than March 15, 1997.
The April survey of Oak Lawn by IDPH was the resurvey to determine whether Oak Lawn had corrected each of the deficiencies identified during the February survey. The surveyors found that, while Oak Lawn no longer had many of the deficiencies found during the February survey, it still remained out of compliance with one Level A requirement: quality of care. This finding was based on IDPH's further findings of non-compliance with five of the Level B requirements which make up the quality of care requirement. The surveyors also found that Oak Lawn had deficiencies in meeting other Level B requirements relating to patient privacy, dignity, and plans of care, which were recorded on the survey report in sections other than under quality of care. A report of these findings was sent to Oak Lawn. By letter dated May 3, 1995, Oak Lawn was notified that its Medicare provider agreement was being terminated effective May 31, 1995.
Oak Lawn timely filed an administrative appeal of HCFA's termination decision. A hearing was held before an ALJ the week of July 15, 1996. The issue before the ALJ was whether Petitioner was out of compliance with the Level A quality of care requirement, codified at 42 C.F.R. . 483.25, at the time of the April 1995 survey. Each party introduced testimony, offered documents which were admitted into the record, and subsequently filed post-hearing briefs.
Following the submission of the post-hearing briefs but prior to the issuance of the ALJ Decision, the Appellate Division of the Departmental Appeals Board issued its decision in Hillman Rehabilitation Center v. HCFA, DAB No. 1611 (1997), which specified how the burdens of production and persuasion should be allocated in provider sanction cases. The ALJ then gave the parties an opportunity to submit written comments on the relevancy and application of Hillman to this case and to discuss whether further proceedings were necessary.
The ALJ determined that no further proceedings were necessary, and on May 21, 1997, issued her decision. The ALJ found that HCFA properly concluded that Oak Lawn failed to comply with the Level A requirement for quality of care and that termination of Oak Lawn from partici- pation in Medicare was proper. This appeal followed.
OAK LAWN'S ARGUMENTS
The ALJ Decision was based on 20 findings of fact and conclusions of law, as follows:
1. HCFA determined that as of the April 1995 resurvey, Petitioner remained out of compliance with the Level A requirement for Quality of Care.
2. The Level A requirement for Quality of Care contained in 42 C.F.R. . 483.25 requires that each resident must receive, and the facility must provide, the necessary care and services to attain or maintain the highest practicable physical, mental and psychological well-being, in accordance with the comprehensive assessment and the plan of care.
3. HCFA's determination of noncompliance with the Level A Quality of Care requirement is based on the resur- vey finding that Petitioner was out of compliance with the Level B Quality of Care requirements per- taining to pressure sores at 42 C.F.R. . 483.25(c); urinary incontinence at 42 C.F.R. . 483.25(d); range of motion at 42 C.F.R. . 483.25(e); accidents at 42 C.F.R. . 483.25(h); and activities of daily living at 42 C.F.R. . 483.25(a).
4. The Quality of Care requirement for "pressure sores" at 42 C.F.R. . 483.25(c) requires that based on the resident's comprehensive assessment, the facility must ensure that 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 a resident having pressure sores receives necessary treatment and services to promote healing, prevent infection and prevent new pressure sores from developing.
5. HCFA established numerous instances, which Petitioner failed to rebut, in which Petitioner failed to meet its obligations under the Level B requirements for pressure sores and failed to follow its written plan of correction to train staff in the importance of quickly assessing skin breakdowns and to take all preventative measures to prevent and heal pressure sores, including repositioning and keeping residents clean and dry.
6. HCFA has proven that Petitioner was out of compli- ance with the "pressure sore" requirements of 42 C.F.R. 483.25(c) at the time of the resurvey.
7. The Quality of Care requirement for "urinary incontinence" at 42 C.F.R. . 483.25(d)(2) requires that based on the resident's comprehensive assessment, the facility must ensure that a resident who is incontinent of bladder receives appropriate treatment and services to prevent urinary tract infection and to restore as much normal bladder function as possible.
8. HCFA established several instances, which Petitioner failed to rebut, in which Petitioner failed to meet its obligations under the Level B requirement for "urinary incontinence" as well as failed to follow its plan of correction to assess each resident for their potential to benefit from a restorative bladder and bowel program and to have such a program in place by March 15, 1995.
9. HCFA has proven that Petitioner was out of compliance with the "urinary incontinence" requirements of 42 C.F.R. . 483.25(d)(2) at the time of the resurvey.
10. The Quality of Care requirement for "range of motion" at 42 C.F.R. . 483.25(e)(2) requires that based on the resident's comprehensive assessment, the facility must ensure that a resident with limited range of motion receives appropriate treatment and services to increase range of motion and/or prevent further decrease in range of motion.
11. HCFA established several instances, which Petitioner failed to rebut, in which Petitioner failed to meet its obligations under the Level B requirement for "range of motion" as well as failed to follow its plan of correction to train CNAs on when to and how to use positioning devices; to have its maintenance department evaluate all wheelchairs to make sure that all parts are in place and are working; and to have its Director of Nursing (DON) and the rehabili- tative coordinator monitor compliance in this area.
12. HCFA has proven that Petitioner was out of compliance with the "range of motion" requirements of 42 C.F.R. . 483.25(e)(2) at the time of the resurvey.
13. The Quality of Care requirement for "accidents" at 42 C.F.R. . 483.25(h)(2) requires that the facility must ensure that each resident receives adequate supervision and assistance devices to prevent accidents.
14. HCFA established instances, which Petitioner failed to rebut, in which Petitioner failed to meet its obligations under the Level B requirement for "accidents" by its failure to properly supervise residents and leaving the residents open to significant health and safety risks including the potential for accidents.
15. HCFA has proven that Petitioner was out of compliance with the requirements for preventing accidents under 42 C.F.R. . 483.25(h)(2) at the time of the resurvey.
16. The Quality of Care requirement for "activities of daily living" at 42 C.F.R. . 483.25(a)(3)(A) requires that based on the resident's comprehensive assessment, the facility must ensure that a resident who is unable to carry out activities of daily living receives the necessary services to maintain good nutrition, grooming and personal and oral hygiene.
17. HCFA established numerous instances, which Petitioner failed to rebut, in which Petitioner failed to meet its obligations under the Level B requirement for "activities of daily living" as well as the provisions of its plan of care because residents identified as needing such assistance did not receive needed assistance with grooming and personal hygiene.
18. HCFA has proven that Petitioner was out of compliance with the "activities of daily living" requirements of 42 C.F.R. . 483.25(a)(3)(A) at the time of the resurvey.
19. The regulations at 42 C.F.R. . 488.26(a) specify that a decision as to whether there is compliance with Level A requirements will depend upon the manner and degree to which a SNF satisfies the various Level B requirements, and pursuant to 42 C.F.R. . 488.24(a), noncompliance with Level A requirements will be found for SNF's "where the deficiencies are of such character as to substantially limit the provider's . . . capacity to render adequate care or which adversely affect the health and safety of patients . . . ."
20. The totality of the evidence surrounding the Level B deficiencies preponderate in favor of HCFA's conclusion that there exists systemic problems which arise to noncompliance with Level A requirement for Quality of Care.
On appeal, Oak Lawn specifically took exception to FFCLs 3, 4, 5, 6, 8, 9, 11, 12, 14, 15, 17, 18, 19 and 20. Most of these exceptions concerned factual findings of the ALJ. Oak Lawn also raised several legal arguments (some of which are applicable to multiple FFCLs), which can be summarized as follows:
Our standard of review of an ALJ Decision on a disputed factual issue is whether the factual finding is supported by substantial evidence. Our standard of review on a disputed issue of law is whether the ALJ Decision is erroneous. See, e.g., Rafael Convalescent Hospital, DAB No. 1616 at 2 (1997); Hillman Rehabilitation Hospital, DAB No. 1611 at 6 (1997); Arcadia Acres, Inc., DAB No. 1607 at 3 (1997).
We have reviewed the evidence of record, including the April survey report and the testimony presented at the hearing, and we have determined that the material factual findings in each of the FFCLs to which Oak Lawn excepted are supported by substantial evidence. The ALJ discussed the evidence in the record which supported each of her findings, and Oak Lawn presented no reason why we should not consider that evidence substantial. Moreover, many of the ALJ's findings turned on her assessment of the credibility of witnesses, to which we give deference on appeal. Thus, we uphold the factual findings in each of the FFCLs to which Oak Lawn excepted.
Below we discuss each of Oak Lawn's legal arguments.
I. The ALJ did not err in failing to dismiss certain findings on the grounds that the conditions of the patients involved did not fall within the particular subsection cited.
The ALJ upheld HCFA's findings, based on the survey report, that Oak Lawn failed to fulfill its duties with regard to aggressively treating and preventing pressure sores among its residents, a Level B requirement under quality of care. The April survey report cited to and quoted subsection 483.25(c)(2) of 42 C.F.R., which requires a long-term care facility to ensure that --
[a] resident having pressure sores receives necessary treatment and services to promote healing, prevent infection and prevent new sores from developing. The survey report did not specifically cite to or quote subsection 483.25(c)(1) of 42 C.F.R., which requires a facility to ensure that --
[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.
Following the citation to subsection (c)(2), the surveyors listed six alleged violations of the pressure sores requirement, of which two pertained to patients who entered the facility with or currently had pressure sores. However, despite the fact that the surveyors did not cite to subsection (c)(1), four of the alleged violations which the surveyors listed pertained to patients who were at risk for pressure sores but neither currently had them nor entered the facility with them. Oak Lawn argued that the findings with regard to these four patients should have been dismissed on the ground that they were not patients having pressure sores, as required by subsection (c)(2).
In her decision, the ALJ found that there was "no support for striking a validly cited failure to meet the regulation as a whole and doing so would defeat the intent of the regulation." ALJ Decision at 22, citing Reply Br. (before the ALJ) at 20. The ALJ found that there was no prejudice to Oak Lawn by the surveyors' failure to cite directly to subsection (c)(1) since Oak Lawn knew of the factual findings with regard to these four patients from their being listed under the quality of care deficiencies in the April survey report.
We fully agree with the ALJ. Oak Lawn knew that the treatment of these four patients with regard to their being at risk of pressure sores (and the facility's alleged failure to keep the residents as dry as possible) was at issue. These four patients and the alleged incidents were listed under the quality of care findings in the April survey report, on which this proceeding is based. Oak Lawn cannot reasonably argue that it was misled by the reference to the incorrect subsection when the nature of the alleged violations together with the citation to the quality of care requirement clearly notified Oak Lawn of the deficiency. Moreover, any long-term care facility certified under Medicare is presumed to be on notice of program requirements through the applicable regulations. Thus, Oak Lawn cannot reasonably argue that it did not know of its duty to aggressively prevent and treat pressure sores in those entering the facility either with or without them, or that it did not know that it would be violating a quality of care requirement by the practices alleged here.
Moreover, HCFA referred generally to 42 C.F.R. . 485.25(c) (in addition to subsection (c)(2)) in its Reply Brief before the ALJ. Even if we assume that this is the first time that Oak Lawn was on notice that the facts as alleged could be violations of either subsection (c)(1) or (c)(2), Oak Lawn did not explain how clarification of the legal authority for the violations after the hearing has prejudiced it. Oak Lawn presented testimony regarding each of the factual allegations related to these residents at the hearing, and did not assert prior to the hearing that the alleged violations should be dismissed based on any deficiency in the cited authority.
Accordingly, we reject Oak Lawn's exception that the findings in question should be dismissed based on a failure to cite to the proper subsection of the regulatory authority.
II. The ALJ did not err by relying on findings which were not cited under the quality of care section of the survey report, nor were these findings necessary to the outcome of this matter.
In her decision, the ALJ found that Oak Lawn did not have a plan of care for addressing a loose prosthesis on one resident, as required by law. The ALJ found that this was a violation of the subsection 483.25(a) "activities of daily living" requirement. The loose prosthesis was not cited in the April survey report as a quality of care violation; rather, it was listed as a failure to develop a comprehensive care plan under section 483.20(d)(1) of the regulations.
The ALJ also found that Oak Lawn failed to timely address the needs of a resident who had a period of incontinence while in the dining room. The ALJ found that this was a violation of the subsection 483.25(c) requirement of keeping residents as dry as possible in order to prevent pressure sores. Like the finding in the previous paragraph, this incident was not cited in the April survey report as a section 483.25 quality of care violation; rather, it was listed in the report as a failure to protect the dignity of each resident in violation of section 483.15(a), a different Level A requirement.
Oak Lawn argued that, given that the termination was based on its alleged failure to meet the Level A quality of care requirement of section 483.25, it was improper for the ALJ to consider these two allegations which were not included in the April survey report specifically under the quality of care violation. HCFA argued in response that some violations could fit under several categories and that the surveyors were not required to list each violation under every category to which it could pertain. Moreover, HCFA argued, the surveyors were not required to list every violation which they found during the survey.
We find, as did the ALJ, that Oak Lawn was not prejudiced by HCFA's determination to rely on these incidents as quality of care violations even though the surveyors did not cite them as violations of the quality of care requirements on the survey report but as violations of other sections. ALJ Decision at 19-20. In its "Statement of Facts, Overview of the Law and Issues of Fact and Law" submitted June 10, 1996 (more than a month prior to the hearing), HCFA stated --
While maintaining its position that evidence related to all deficiencies is relevant and should be admitted, HCFA anticipates focusing its evidentiary presentation in the upcoming hearing primarily on the Level A Quality of Care deficiency, presenting evidence related to this deficiency from both surveys. Because of the overlap between requirements (e.g. dietary deficiencies which impact on quality of care), HCFA anticipates presenting findings from both surveys which relate to the Quality of Care deficiency regardless of whether the surveyors recorded the findings under Quality of Care or some other requirement.
HCFA's June 10, 1996 submission, p.11. Moreover, HCFA referred in its submission several times to the Level B deficiencies which were repeat violations of resident privacy, dignity or quality of life requirements. Id. at 7, 10, 11. If Oak Lawn needed further clarification as to what would be at issue at the hearing, it had a duty to request it. Under the circumstances presented here, Oak Lawn may not reasonably argue that it was either surprised or prejudiced by HCFA's reliance on these findings. Moreover, with regard to both the prosthesis and urinary incontinence allegations, Oak Lawn had an opportunity to present evidence addressing the incidents following HCFA's witnesses' testimony. With regard to the urinary continence incident, the ALJ specifically found that Oak Lawn did not do so. See ALJ Decision at 20.
Finally, even if we were to find that Oak Lawn was prejudiced with regard to the ALJ's reliance on these findings (which we do not) and we were to strike them from the ALJ Decision, it would not change the outcome of the case. There would still be more than sufficient evidence that Oak Lawn failed to meet the Level A quality of care requirements of 42 C.F.R. . 483.25 based on other findings.
III. The ALJ did not fail to consider the nature and extent of the violations in upholding the termination.
Section 488.26 of 42 C.F.R., which provides the basic requirements for determining compliance of a facility with Medicare requirements, requires the surveyors to consider the nature and extent of the deficiencies found during the survey. Non-compliance with a Level A requirement will be found where "the deficiencies are of such character as to substantially limit the provider's . . . capacity to furnish adequate care or which adversely affect the health and safety of patients . . . ." 42 C.F.R. . 488.24(a). In determining the nature and extent of the deficiencies, the surveyors are to consider resident outcomes:
The survey process uses resident outcomes as the primary means to establish the compliance status of facilities. Specifically surveyors will directly observe the actual provision of care and services to residents, and the effects of that care, to assess whether the care provided meets the needs of individual residents.
42 C.F.R. . 488.26(b)(2).
Oak Lawn argued that the ALJ erred in finding that the nature and extent of the individual violations supported a finding of a Level A quality of care violation. Oak Lawn urged that the alleged deficiencies in meeting each Level B requirement were insufficient in frequency and severity to provide grounds for a termination. Moreover, Oak Lawn argued that the surveyors failed to prove a single instance of an avoidable negative outcome to a resident, which Oak Lawn asserted was the primary measure of whether a provider was failing to meet a Level A requirement.
We find that the ALJ did not err in concluding that the nature and extent of the individual violations were sufficient to justify a finding that Oak Lawn was not meeting the Level A quality of care requirement. While there was conflicting testimony at the hearing with regard to most of the findings, the ALJ determined that HCFA's witnesses were more credible than Oak Lawn's in many instances. See ALJ Decision at 18, 29, 33, 36. Based on the testimony of HCFA's witnesses, there is substantial evidence in the record on which the ALJ could have reasonably determined that Oak Lawn failed to meet each of the Level B requirements at issue pertaining to pressure sores, urinary incontinence, range of motion, accidents, and activities of daily living. The ALJ discussed the frequency and severity of the deficiencies throughout her decision, and we do not find her conclusions to be erroneous. ALJ Decision at 29, 33, 36-38.
Moreover, the record supports the conclusion that the surveyors specifically considered "resident outcome" in identifying violations during the April survey. The regulation contemplates simply that the surveyors will directly observe the actual provision of care to the residents and the effects of that care. See 42 C.F.R. . 488.26(b)(2). The Board has previously held that a potential for harm is sufficient to find that a provider's deficiencies are of such character as to limit the provider's "capacity to render adequate care" or to "adversely affect the health and safety of patients" under 42 C.F.R. . 488.24(a). National Hospital for Kids in Crisis, DAB No. 1600 (1997). Here, for example, where there was evidence on which the ALJ found that patients were not properly groomed and were left in wet bedding for more than an hour even after Oak Lawn's employees were told the patients were wet, there was sufficient evidence of improper care and undesirable negative effects on the residents as well as of actual harm or the potential for harm. See ALJ Decision at 12-13, 16-18, 34-36. Thus, contrary to what Oak Lawn seemed to be arguing, HCFA properly considered resident outcomes in its determination.
IV. The surveyors properly conducted the survey with regard to making observations, interviewing the residents, and reviewing patient records. The regulations require surveyors to abide by the survey methods, procedures, and forms prescribed by HCFA. 42 C.F.R. . 488.26(c). Surveyors are required to review records, observe residents, and conduct interviews as part of the survey. 42 C.F.R. . 488.26(e)(3); see also "Survey Protocol for Long Term Care Facilities," Appendix P, p.15, to State Operations Manual, Provider Certification, Transmittal No. 250, April 1992, attached to HCFA Br.
Oak Lawn argued that, with regard to many of the findings, none of HCFA's witnesses actually observed or interviewed the patients or reviewed their medical records. According to Oak Lawn, HCFA's witnesses were relying on record reviews and notes made by other surveyors who did not testify at the hearing. It is undisputed that, in at least one instance, the surveyors relied on the condition of a resident's pressure sore as recorded by Oak Lawn's employees in her medical records without actually observing the resident themselves. Oak Lawn argued that the surveyors failed to follow proper survey protocol in conducting the surveys which were the basis for HCFA's decision to terminate.
We conclude that the ALJ fully addressed these arguments in her decision and that she did not err in concluding that HCFA's surveyors conducted an appropriate survey. The ALJ found that it was standard survey practice to apportion responsibility for record reviews among team members and to rely on each other's findings as recorded in the survey report generated in the ordinary course of business. ALJ Decision at 15 and 29, n.13. She also suggested that it was reasonable for the surveyors to rely on an entry in a medical record made by the provider's staff without actually observing a patient's skin condition. ALJ Decision at 15. It is clear moreover that many of the findings of quality of care deficiencies were based on observations of the actual provision of care and services to the residents. Stating that the survey process is not an exact science and that the guidelines are not precise formulas, the ALJ emphasized that the trained surveyors are to apply their professional judgment to their observations, and that here they reasonably concluded that Oak Lawn did not meet the Level A quality of care requirement. ALJ Decision at 37; see also 42 C.F.R. . 488.26(b)(3).
V. Oak Lawn was not prejudiced by the ALJ's application of the Board's decision in Hillman Rehabilitation Hospital to this case.
The ALJ's pre-hearing order dated May 14, 1996 contained the following paragraph:
Burden of proof: For purposes of this hearing, HCFA shall have the burden of coming forward, to establish by a preponderance of the evidence, that Petitioner was not in compliance with the cited Level A requirement as of the date specified in HCFA's notice of adverse action. Petitioner has the burden of coming forward with evidence in support of Petitioner's arguments.
On February 28, 1997, after the hearing in this matter was concluded and the post-hearing briefing completed, but prior to the issuance of the ALJ Decision, the Appellate Division of the Departmental Appeals Board issued its decision in Hillman Rehabilitation Center v. HCFA. See DAB No. 1611 (1997). That decision addressed how the burden of production and the burden of persuasion should be allocated in Medicare provider sanction cases. Because the ALJ was concerned that the holdings of Hillman on these matters were not completely consistent with the holdings in one of the ALJ's prior decisions on which Oak Lawn relied, the ALJ provided both parties with an opportunity to submit written comments on the relevancy of Hillman to this case and on whether additional proceedings were necessary.
Initially, Oak Lawn strongly protested the application of Hillman on the grounds there had been long delays in the proceedings before that ALJ and that, had the ALJ Decision been issued earlier, the holdings in Hillman would not have been a consideration. HCFA responded that the holdings in Hillman were correct and should be applied to this case, but that the application of Hillman here did not warrant additional proceedings. In response, Oak Lawn insisted that, if the holdings in Hillman were applied to this case, then a new hearing must be held since Oak Lawn would have a greater burden under Hillman and had proceeded in good faith at the hearing based on the ALJ's May 14, 1996 pre-hearing order.
The ALJ proceeded to decision following the briefing on the Hillman issue. She concluded that the holding in Hillman on the burden of production was consistent with her May 14, 1996 pre-hearing order. She found that the burden of persuasion was clarified by the Hillman decision: after Hillman, it was clear that the provider, rather than HCFA, would lose in a sanction case if the evidence on both sides of the case was "in equipoise." Finding that the evidence in this case was not in equipoise, the ALJ concluded that the Hillman decision was not directly applicable. Thus, there was no reason to hold a new hearing.
Before the Board, Oak Lawn argued that it was signifi- cantly prejudiced by the "change in burden of proof." Reply Br. at 6. Oak Lawn stated that it had maintained throughout the hearing that the surveyors had documented no negative resident outcome from the alleged deficiencies found in the April survey, and that the change in burden of proof meant that Oak Lawn would have been expected to prove the absence of any negative outcomes.
We conclude that the ALJ did not err in determining that no new proceedings were necessary. We agree that the ALJ's summary of the burden of production, as stated in her May 14, 1996 order, was not altered by Hillman. While Hillman concluded that the burden of persuasion was different than that assumed by Oak Lawn, the ALJ did not find, nor Oak Lawn convincingly argue, that the evidence was in equipoise. In fact, the ALJ specifically found to the contrary.
Oak Lawn argued that it is entitled to a new hearing because, after Hillman, it would be required to meet the higher standard of proving a total absence of any negative outcomes rather than the lower standard of merely showing that HCFA failed to prove any negative outcomes in patient care. Oak Lawn misconstrues the effect of the "resident outcome" provision in the regu- lation, as well as the effect of the Hillman decision. As we stated previously, "resident outcome" as used in the regulation merely requires surveyors to consider the actual provision of care and the effects of that care, including the potential for harm and any actual harm. Moreover, as discussed above, the Hillman decision merely clarified the burden of persuasion but did not affect the burden of production as it would be applied here. In any event, as we stated in the previous section, we find that the surveyors properly considered resident outcome in identifying violations during the April survey.
Conclusion
For the reasons stated above, we uphold in full the ALJ Decision. We find that the ALJ did not err in concluding that Oak Lawn failed to provide the necessary care and services to help each resident attain or maintain the highest practicable physical, mental, and psychosocial well-being, in violation of 42 C.F.R. . 483.25. We affirm and adopt Findings of Fact and Conclusions of Law 1-20 in the ALJ Decision.
____________________________
Cecilia Sparks Ford
____________________________
Norval D. (John) Settle
____________________________
Donald F. Garrett
Presiding Board Member