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Department of Health and Human Services DEPARTMENTAL APPEALS BOARD Appellate Division |
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DATE: November 30, 2001 |
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Centers for Medicare & Medicaid
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Docket No. A-01-108
Civil Remedies CR801 Decision No. 1800 |
| DECISION | |
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FINAL DECISION ON REVIEW OF On August 24, 2001, Emerald Oaks requested review of the July 26, 2001 decision of Administrative Law Judge (ALJ) Marion T. Silva upholding the authority of the Centers for Medicare and Medicaid Services (CMS)(1) to terminate its provider agreement and concluding that the per instance civil monetary penalty (CMP) of $10,000 was reasonable. Emerald Oaks, DAB CR801 (2001)(ALJ Decision). Emerald Oaks did not contest the facts underlying the immediate jeopardy finding that was the basis for the CMP, but argued that the CMP amount was unreasonable. Emerald Oaks further argued that a fair review of all the evidence before the ALJ would require a reversal of the termination. In addition, Emerald Oaks contended that the factual discussion of one requirement with which the ALJ found Emerald Oaks was in substantial compliance nevertheless presented an unfairly derogatory picture of the facility, and it sought to have the discussion replaced. We find no error in the ALJ's determination that the CMP amount was reasonable. After review of the entire record, we find that substantial evidence exists to support each of the challenged ALJ factual findings. We decline to modify the discussion in the ALJ Decision regarding the overturned deficiency finding. For the reasons explained below, we affirm the ALJ Decision and sustain all of the findings of fact and conclusions of law (FFCLs) therein. Factual and Procedural Background Emerald Oaks is a nursing facility in Sarasota, Florida that was terminated from the Medicaid and Medicare programs on October 30, 2000. CMS took this action because it concluded that Emerald Oaks had been out of compliance with applicable participation requirements for six months. The termination went into effect after four surveys conducted at the facility by the State survey agency on the following dates: May 3, June 15, August 31, and October 26, 2000. After the May 3 survey, CMS imposed the $10,000 per instance CMP based on the finding of a deficiency which presented an immediate jeopardy to the residents. After the June 15 survey, HCFA proposed to deny payment for new admissions effective August 29. After the August 31 survey, HCFA proposed to terminate Emerald Oaks effective October 30 unless the facility achieved substantial compliance before that date. At that point, Emerald Oaks filed a timely appeal, docketed on October 23, 2001, and contested CMP's basis for these three remedies. On October 26, 2000, a revisit survey found two deficiencies. CMS concluded that termination was mandatory because Emerald Oaks did not achieve substantial compliance for six months after it was initially found to be non-compliant. After receiving notice from CMS that its termination had gone into effect, Emerald Oaks amended its pending hearing request to add the deficiency findings from the October survey. Emerald Oaks sought an expedited hearing. The parties agreed to an expedited hearing limited in scope to whether CMS had a basis to impose the $10,000 CMP arising from the May survey and whether a basis exists to terminate Emerald Oaks's provider agreement. Emerald Oaks stipulated at the hearing that it challenged the CMP by contesting only the relevant finding of noncompliance from the May survey and the termination by contesting only the deficiency findings from the October survey. In her decision, the ALJ rejected Emerald Oaks's motion for summary disposition made at the close of CMS's case. The ALJ then considered the record as a whole and made nine FFCLs, accompanied by a discussion of the basis for each. Emerald Oaks stated on appeal that it did not seek review of the first two FFCLs, which are set out here:
ALJ Decision at 5-6 (bold in original). Consequently, we affirm these FFCLs as uncontested. Emerald Oaks excepted to FFCLs 3-9. The text of each of those findings is set out in the portion of the analysis discussing the issues raised by Emerald Oaks in relation to each FFCL. Legal Background The statute and regulations provide a number of remedies that may be imposed by CMS when a facility is found not to comply substantially with the requirements for participation in the Medicare and Medicaid programs. Sections 1819 and 1919 of the Social Security Act; 42 C.F.R. Parts 483, 488, and 498. The remedies selected may include termination, alternative sanctions (such as denial of payment for new admissions or CMPs), or both. "Substantial compliance" is defined as "a level of compliance with the requirements of participation such that any identified deficiencies pose no greater risk to resident health and safety than the potential for causing minimal harm." 42 C.F.R. � 488.301. Sections 1819(h) and 1919(h) of the Act authorized imposition of CMPs to remedy noncompliance at amounts not to exceed $10,000 per day. Regulations provide for different ranges of CMPs depending on the nature and seriousness of the non-compliance. 42 C.F.R. �� 488.408. In particular, in cases involving immediate jeopardy determinations, CMS may impose either a per day CMP in the range of $3,050 to $10,000 or a per instance CMP of $1,000 to $10,000 per instance (not to exceed a daily amount of $10,000), but not both. Id.; 64 Fed. Reg. 13,354 (March 19, 1999). Our Standard of Review Before the ALJ, the sanctioned facility must prove substantial compliance by the preponderance of the evidence, once CMS has established a prima facie case that the facility was not in substantial compliance with relevant statutory or regulatory provisions. See Cross Creek Health Care Center, DAB No. 1665 (1998), applying Hillman Rehabilitation Center, DAB No. 1611 (1997)(Hillman), aff'd, Hillman Rehabilitation Center v. HHS, No. 98-3789(GEV), slip op. at 25 (D.N.J. May 13, 1999). Upon review of an ALJ Decision, the standard of review we apply on a disputed conclusion of law is whether the ALJ erred. Our standard of review on a disputed finding of fact is whether the ALJ's finding is supported by substantial evidence on the record as a whole. Guidelines for Appellate Review of Decisions of Administrative Law Judges Affecting a Provider's Participation in the Medicare and Medicaid Programs; see also Hillman, at 6 (1997)); Fairview Nursing Plaza, Inc., DAB No. 1715, at 2 (2000); South Valley Health Care Center, DAB No. 1691 (1999). We have repeatedly held that the role of appellate review is not to substitute our evaluation of the evidence for that of the ALJ, but only to determine whether the factual findings made by the ALJ are supported by substantial evidence in the record as a whole. See Lake Cook Terrace Center, DAB No. 1745, at 6 (2000); Beverly Health and Rehabilitation - Spring Hill, DAB No. 1696, at 40 (1999). Issues on Appeal The basis for Emerald Oaks's argument that the CMP based on the immediate jeopardy determination was unreasonable centered on its assertion that CMS was obliged to present proof of its consideration of specific regulatory factors as part of CMS's prima facie case in support of a particular amount of CMP. Emerald Oaks also argued that the ALJ did not understand properly her role in reviewing the reasonableness of the amount of a CMP. Emerald Oaks excepted to the ALJ's finding that it neglected one resident in a manner that evidenced failure to implement a policy adequate to prevent neglect from occurring. Emerald Oaks asserted that the ALJ applied inappropriate standards of review in her analyses of disputed issues of fact underlying this and other findings. As to this particular finding, Emerald Oaks argued that the ALJ materially erred in describing clinical facts in the record concerning the resident involved; ignored evidence presented by Emerald Oaks that contradicted charges of neglect; second-guessed the professional judgment of nurses caring for the resident; and misapplied the cited regulation by treating an isolated incident out of context as proof of failure to implement policies to prohibit neglect. Emerald Oaks excepted to the ALJ's finding that CMS did not substantiate a deficiency finding under the same regulation in relation to a different resident. Emerald Oaks argued that the ALJ's discussion of the evidence and inferences were not supported by the record and "reflect poorly on Emerald Oaks, and thus should be set aside." Emerald Oaks Br. at 30. The three remaining ALJ findings challenged by Emerald Oaks involved allegations of failure to meet professional standards of care in the treatment of three residents. In each instance, Emerald Oaks denied that the record taken as a whole provided substantial evidence in support of the ALJ's findings, which Emerald Oaks described as effectively parroting the surveyors' findings and disregarding testimony and evidence presented by Emerald Oaks. In addition, Emerald Oaks argued that the errors alleged, even if shown, did not rise to the level of violations of professional standards and did not result in any harm or realistic risk of harm to the residents. Overall, Emerald Oaks characterized CMS as imposing a strict liability or "zero tolerance" policy. |
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| ANALYSIS | |
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1. Emerald Oaks's exception to Finding 3 is without merit.
Emerald Oaks excepted to the ALJ's Finding 3 which read as follows:
ALJ Decision at 11 (bold in original). The core of Emerald Oaks's objection was that CMS failed to put on any evidence that it considered the requisite regulatory factors in determining the amount of the CMP to impose.(2) Further, Emerald Oaks argued that the ALJ was without authority to go forward to determine the reasonableness of the amount of the penalty absent such evidence as part of CMS's prima facie case. In particular, Emerald Oaks argued that it was important that it be able to cross-examine witnesses about CMS's consideration of the regulatory factors in this case because CMS decided to impose a penalty different from that originally recommended by the State survey agency. See Emerald Oaks at 6-7, and record citations therein. The basis for selecting the amount of a CMP is the assessment of four factors:
42 C.F.R. � 488.438(f)(italics in original). The factors specified in � 488.404 are those considered in selecting any particular remedy. The regulation calls for an initial assessment by CMS of the seriousness of the deficiency, including the degree of harm or risk of harm that the deficiencies involved present and whether they are isolated, part of a pattern, or widespread. 42 C.F.R. � 488.404(b). In addition, CMS may consider "other factors, which may include, but are not limited to," how the deficiencies relate to each other and what prior history exists of "noncompliance in general and specifically with reference to the cited deficiencies." 42 C.F.R. � 488.404(c). Emerald Oaks contended that the ALJ erred by making a de novo determination that the $10,000 per instance CMP was reasonable even though CMS did not present evidence of how each of these factors was weighed by CMS in arriving at that amount. As noted above, Emerald Oaks did not challenge, and we have therefore affirmed, the ALJ's factual findings concerning this deficiency.(3) By way of context, we summarize here the basic events which the ALJ found to have occurred; the facts are set out more fully in the ALJ Decision. The resident involved had been diagnosed with multiple serious ailments, including heart disease, diabetes, and chronic airway obstruction. See ALJ Decision at 7-8, and record citations therein. His wife asked a nurse for help because he was having trouble breathing, but the nurse only "peeked in," indicating that she and her co-workers were "too busy" with other residents. Id. at 8. Emerald Oaks's staff called the fire department for emergency assistance for the resident about an hour and a half after the wife first reported his breathing difficulty. Id. The paramedic who arrived on the scene testified at the hearing that she found the resident, attended only by his hysterical wife, in critical condition with a fever of 105 degrees, lacking oxygen, and with no detectable blood pressure. Id. at 9. She also testified that she had to send a crew member to find a facility staff member, and even then was unable to obtain adequate information about the resident from either the certified nursing assistant or the nurse on duty. Id. The resident died within 20 minutes of being intubated and transported to the hospital. Id. Based on this, the ALJ sustained CMS's finding that Emerald Oaks was not in compliance with regulatory requirements for implementing adequate policies on staff treatment of residents, and further concluded that CMS was not clearly erroneous in finding that the situation constituted immediate jeopardy. Id. at 9-11. Emerald Oaks did not contest on appeal these facts or the deficiency finding but argued that CMS presented no witness to relate how the $10,000 CMP amount was determined and how the regulatory factors were applied. Emerald Oaks asserted that the state survey agency originally cited the deficiency at a lower level of severity and recommended a "per diem" CMP, while CMS imposed a "per instance" CMP.(4) See generally 42 C.F.R. � 488.408. The ALJ rejected the contention that CMS should have proven why it deviated from the state agency recommendations, and also found that Emerald Oaks had presented no evidence as to the regulatory factors. ALJ Decision at 11-12. The ALJ concluded that, after a review of all the factors, and in particular based on the degree of culpability (defined to include neglect and disregard for resident care and safety), the CMP imposed was reasonable. Id. B. The ALJ did not err in concluding that the CMP amount was reasonable without examining CMS's internal considerations. Emerald Oaks confused the nature and function of the prima facie case which CMS is required to make in order to require a provider to prove its substantial compliance by the preponderance of the evidence with the issue of what showing must be made to overturn the amount of a CMP. Given the variety of assertions that Emerald Oaks made at various junctures about how the prima facie case prerequisite should play out in a hearing, we set forth the correct analytical framework developed in prior Board decisions as a starting point to evaluating Emerald Oaks's arguments. In Hillman, the Board set out the following framework for ALJ hearings on disputed issues of fact in provider termination cases:
Hillman, DAB No. 1611, at 65; see also Cross Creek Health Care Center, DAB No. 1665 (1998)(same framework applies in cases involving CMPs). It is critical to understand that this analysis is applied to determine disputed questions of fact regarding whether a basis exists to impose a sanction, and not to second-guess the selection of the appropriate sanction. The ALJ's review of the decision to impose a CMP of a particular amount is not co-extensive with CMS's discretion in making this choice initially. Board precedents have derived this conclusion from a careful review of the statute, regulations, and the preamble to the regulations at 42 C.F.R. Part 488. CarePlex of Silver Spring, DAB No. 1683, at 13-17 (1999). Those authorities essentially demonstrate an intention "to permit review of the factual underpinnings on which the remedy is based (including the specific factual elements on which the amount of the CMP is determined) but to make unreviewable the decision to impose a remedy and the choice of that remedy." Id. at 16-17. Therefore, once the ALJ has determined that a basis existed to impose a CMP, the ALJ "may take evidence on contested issues as to the facility's history of noncompliance, financial condition, and degree of culpability (if used as an aggravating factor). . . ." Id.(5) Emerald Oaks nevertheless argued that the ALJ misread our decision in CarePlex, which it described as holding that "before an ALJ may exercise her authority to modify a CMP, she must first find that HCFA exercised its discretion to impose the CMP improperly." Emerald Oaks Br. at 10. Emerald Oaks then inferred that, absent the presentation of any evidence by CMS on its consideration of the regulatory factors by CMS itself, the CMP could not be sustained at all. We find that the misunderstanding lies instead with Emerald Oaks's own misinterpretation of our precedents. As noted above, our decisions, and the regulations, do not require an ALJ to make any finding concerning how CMS exercised its discretion in selecting a remedy or setting the amount of a penalty. In CarePlex, the Board held expressly that the ALJ should not look into the "internal decision-making processes of the officials at HCFA or the State." DAB No. 1683, at 8.(6) Rather, the ALJ is to consider -
Id. In assessing the reasonableness of the amount imposed, the ALJ is thus constrained by the regulations which present objective factors to guide the determination. Id. This limitation on the ALJ's review is based inter alia on the regulatory provision that an ALJ may not "consider any factors in reviewing the amount of penalty" other than those discussed above that CMS is to consider. 42 C.F.R. � 488.438(e)(3).(7) Emerald Oaks further contended that the ALJ mistook her role by concluding, in the absence of any evidence from CMS or Emerald Oaks regarding the regulatory factors, that the CMP amount was reasonable. Emerald Oaks Br. at 12; cf. ALJ Decision at 12. Emerald Oaks characterized this as a "sloppy" interpretation of the regulations and "ex parte" in that the basis for CMS's choice of the amount was untested. Emerald Oaks Br. at 12-13. Emerald Oaks characterized the effect of a decision that CMS need not put on evidence of its internal consideration of the regulatory factors in selecting a CMP amount as casting the ALJ as "simply an adjunct to HCFA's enforcement and remedy-selection process" rather than "an impartial arbiter of the evidence." Emerald Oaks Br. at 9. The choice implied by Emerald Oaks was that, if CMS did not have to present evidence of its consideration of the regulatory factors leading to the amount of CMP imposed, then either the ALJ was simply acting on her own to choose a CMP independent of CMS and without an opportunity for Emerald Oaks to test the basis of her choice, or the ALJ was rubber-stamping CMS's choice as presumptively correct "without respect to the evidence HCFA offers at the hearing." Emerald Oaks Br. at 8-9. Contrary to Emerald Oaks's arguments, our analysis does not render the regulatory factors a nullity or distort the proper role of the ALJ. The dichotomy presented by Emerald Oaks is a false one. The ALJ's role as defined both in the regulations and by our precedents is indeed that of an impartial reviewer. The ALJ is neither bound to defer to CMS's assertions nor free to make a wholly independent choice of remedies without regard for CMS's discretion. The ALJ is rather to determine whether the amount of any CMP imposed by CMS and challenged by the facility is within reasonable bounds in light of the purpose of the statute and regulations. If the facility presents evidence relevant to any of the regulatory factors in order to contest the reasonableness of the amount of the CMP, the ALJ is to weigh that evidence, along with all the evidence presented by CMS, in making that determination. As the Board explained in CarePlex:
DAB No. 1683, at 17-18 (citation omitted). Thus, contrary to Emerald Oaks's position, the purpose of the hearing here was not to determine whether CMS followed the correct procedure in determining to impose a CMP or setting the amount of the CMP. The hearing at the ALJ level in such cases is intended to determine two fundamental questions: (1) whether a basis existed to support the imposition of the CMP under the governing statutory and regulatory authorities, and (2) whether the amount of the CMP fell within a reasonable range based on the applicable law. The ALJ resolves these issues de novo in the sense that the determination is based on the evidence as it is developed before the ALJ and not on how CMS evaluated the evidence as it stood at whatever point CMS made its assessment. The ALJ in this case conducted the correct inquiry. See ALJ Decision at 11-13. She found that Emerald Oaks had presented no evidence for any regulatory factor that might have reduced the appropriate amount. Id. at 11. She concluded that the factors relating to scope and severity, and especially the degree of culpability, demanded a "severe penalty," and hence that the amount imposed was within the reasonable range of amounts appropriate to achieving the remedial purposes of such sanctions. We conclude that the ALJ made no error and affirm her finding. 2. Emerald Oaks's exception to Finding 4 is without merit.
Emerald Oaks excepted to the ALJ's Finding 4 which read as follows:
ALJ Decision at 13 (bold in original). The allegations underlying this finding involved distinct periods of time. On October 20, 2000, the resident experienced two brief episodes in which he was found lying across his bed unresponsive with altered vital signs, after several days of increased confusion. The resident's physician was not contacted after the first episode; when he was called after the second episode, he ordered immediate hospitalization. When he was returned from the hospital on October 23, the resident fell, suffered injuries, was returned to the hospital, and readmitted to the facility in the evening and placed in the same room in a "pod" area down the hall from the nursing station. In the early hours of October 24, he fell again twice. The physician was notified the following morning. On the afternoon of October 25, the surveyor observed the resident unrestrained in a straight chair hitting his head against the wall twice while trying to stand. The resident was found to have a piece of plastic in his mouth. An hour later, the resident had a seizure and was sent to the hospital again by the medical director. CMS alleged that the resident was neglected because he was not adequately monitored or supervised to prevent injury and his physician was not notified of important changes in his condition. CMS alleged that these omissions put him at risk for harm that was at least greater than minimal. In its reply brief, Emerald Oaks raised for the first time a suggestion that the ALJ "confused" the governing standard of review and the "concept of 'substantial evidence'." Emerald Oaks Reply Br. at 3. This argument affects how the exceptions to the bases for the ALJ's other factual findings were framed as well. We therefore address it as a preliminary matter in this section in relation to the first such exception, and will apply our conclusions in relation to all the succeeding exceptions. Emerald Oaks also argued that the regulation under which it was cited could not, as a matter of law, be applied to a situation in which neglect of an individual is charged based on what Emerald Oaks characterized as "no more than a series of observations and events regarding the Resident's (declining) condition." Emerald Oaks Br. at 26. Emerald Oaks described CMS as employing the requirement to develop and implement anti-neglect policies as a kind of catchall category for citing "any disagreement they have with a nurse's professional judgments - or even simple bad clinical outcomes." Id. at 26-27. Finally, Emerald Oaks attacked many of the ALJ's descriptions of events as inaccurate and derived simply from the statement of deficiencies. Further, Emerald Oaks argued that its own detailed clinical and factual evidence was entirely disregarded.
The ALJ set out the governing standard as follows: "the preponderance of the evidence standard is applied to resolve disputed issues of fact." ALJ Decision at 3-4. Emerald Oaks, however, characterized "preponderance of the evidence" as a mere "evidentiary standard" while insisting that the proper standard of review for the ALJ was a "substantial evidence test" which constituted the "method for applying the facts to such legal standards" as the "applicable regulatory and professional standards." Emerald Oaks Reply Br. at 3-4, 6. Emerald Oaks described the approach it understood a "substantial evidence test" to imply as a de novo "balanced review of the evidence," while it characterized the ALJ as instead using "some kind of 'reasonable ALJ' or 'reasonable layperson' standard" in determining whether an event constituted a deficiency. Id. at 4. According to Emerald Oaks, the result of the ALJ's confusion was that the ALJ considered and discussed only CMS's evidence and failed to give appropriate weight to clinical records and expert testimony presented by the facility. Id. at 7. The alleged error was compounded by CMS's response brief which Emerald Oaks characterized as arguing that "its evidence alone constitutes 'substantial evidence in the record' that 'supports the ALJ's factual findings.'" Id. at 8, citing CMS Resp. Br. at 9, 11, 23, 30, 37, and 40. Emerald Oaks's discussion, as reflected in the preceding summary, scrambled the meaning of various approaches to resolving disputed issues of fact at various levels of review. Rather than attempt to disentangle all the multiple conflicting characterizations of these standards set out in Emerald Oaks's briefs, we summarize here the settled law as to the applicable standards of review in provider sanction cases.(8) We have set out in the preceding section the process of review before the ALJ on disputed issues of fact. It follows from that discussion that, in determining whether a prima facie case has been presented, the ALJ looks only at the evidence put forward by CMS. VITAS Healthcare Corp. of America, DAB No. 1782, at 11-19 (2001). Absent a showing sufficient standing alone to support the basis for CMS's action, no further evaluation of conflicting evidence is necessary. Assuming a prima facie case exists, the ALJ must review all the evidence in the record and apply the preponderance of the evidence standard to determine whether the facility has proven that it was in substantial compliance with the applicable standards. The preponderance of the evidence standard means that the party with the burden, here Emerald Oaks, had to show that it was more likely than not that it was in substantial compliance as to each disputed deficiency finding. Under this standard, if the evidence in the record as a whole is in equipoise as to a disputed fact, that fact is resolved against the party with the burden to prove it. Hillman, at n.7. The ALJ's review is indeed de novo, as we have said, in that the evidence to be weighed is that developed before the ALJ, not merely that on which CMS based its action. Each piece of evidence is to be given such weight as it deserves, depending on such factors as its relevance, reliability, credibility of the source, relevant expertise and factual underpinnings of opinion testimony, and so on. Contrary to Emerald Oaks's implication, no special standard of review applies to "technical or medical evidence." Cf. Emerald Oaks Reply Br. at 4. The "substantial evidence in the record as a whole" test, by contrast, is a deferential appellate standard and not relevant to the ALJ's deliberations, but rather to our review of the ALJ's factual findings. As the authorities cited by Emerald Oaks make clear, we must find that the ALJ's finding is supported by "such relevant evidence as a reasoning mind might accept as adequate to support a conclusion" taking into account as well "whatever in the record that fairly detracts" from the weight of evidence underlying the ALJ finding. See Emerald Oaks Reply Br. at 7, quoting AT&T Corp. v. FCC, 80 F.3d 242, 247 (D.C. Cir. 1996) (citations and internal quotations omitted). Rather than setting a higher "balanced review" test as compared to the "preponderance of the evidence," a substantial evidence review results in upholding the finding at issue whenever the record as a whole contains "more than a mere scintilla" of rational support unless taking contradictory evidence into account reduces the supportive evidence to insubstantiality. Landry v. FDIC, 204 F.3d 1125, 1140 (D.C. Cir. 2000). While CMS's brief indeed argues that substantial evidence in the record as a whole supports the ALJ's findings in its favor, we do not read that to suggest that CMS believed the ALJ did or should have applied such a standard but rather that CMS correctly understood that to be the standard for our appellate review. Furthermore, although Emerald Oaks complained that CMS bolstered its arguments with recitations of its own evidence, our review is to take into account evidence contrary to the findings in determining whether the record as a whole provides substantial evidence to support them. Finally, Emerald Oaks alleged that the ALJ applied "some kind of impressionistic 'reasonable ALJ' standard that essentially disregarded the lengthy and complex medical and technical evidence Emerald Oaks offered." Nowhere in her decision does the ALJ articulate a subjective reasonableness test that overrides medical or other expert testimony or legal requirements in evaluating deficiency findings. Hence, this allegation appears to amount to a complaint that, in Emerald Oaks's opinion, the ALJ did not consider or did not give appropriate weight to particular evidence in resolving particular factual disputes. Such a complaint is best addressed in the context of the particular disputes as we do below.
CMS argued that Emerald Oaks's neglectful treatment of Resident 10 violated the requirement that a facility must implement a written policy sufficient to prohibit neglect of residents under 42 C.F.R. � 483.13(c)(1)(i). The ALJ concluded that this regulation, which addresses a deficiency related to lack of an effective policy as opposed to one directed at the occurrence of neglect itself, was properly applied here. ALJ Decision at 8. She reasoned that "it is not unreasonable to infer a failure by a facility to implement its policy if sufficient examples of neglect at a facility establish a systemic failure by the facility to do so." Id. The narrow question at issue appears to be one of first impression before this Board. In the absence of binding appellate precedent, both parties relied on various ALJ decisions, but failed to demonstrate that the reasoning in those cases persuasively resolved the issue here. Emerald Oaks cited four ALJ decisions for the propositions that (1) this regulation does not prohibit neglect per se but rather addresses a requirement to develop and implement policy and (2) neglect cannot be supported by taking "isolated events out of context." See Emerald Oaks Br. at 25-26, and ALJ decisions cited therein. CMS cited two decisions in which other ALJs upheld deficiency findings arising from this regulation based on facilities' failures to take action in the face of known risks to residents or to provide care that a facility had itself identified as necessary. See CMS Br. at 10-11, and ALJ decisions cited therein. The factual scenarios presented in this case do not parallel exactly the situations in the ALJ decisions referenced by CMS so they are of limited value in comparing the analyses of those ALJs as to what neglect findings implicate a policy failure. At the same time, the ALJ here made no ruling inconsistent with the propositions for which Emerald Oaks cited to other ALJ decisions. She did not suggest that this requirement addresses neglect in itself nor that isolated events taken out of context prove a violation of the policy requirement. Instead, she ruled that a breach of the requirement to implement an anti-neglect policy can be shown by sufficient examples of neglect to show systematic problems. We find the ALJ's formulation persuasive. Emerald Oaks offered nothing that effectively countered her reasoning. It is evident on the face of the regulations that this provision addresses adopting effective anti-neglect and abuse policies, not targeting isolated events. Nevertheless, implementing policies clearly means something more than maintaining a paper file of documents without actually regulating staff actions. A pattern of recurring neglect can reasonably raise the inference drawn by the ALJ that no policy against neglect has been systematically implemented at the facility. Emerald Oaks did not point to evidence of what its written policies were and how they were implemented. Instead, it contended that it had no adequate notice of risk or foreseeable harm to justify considering its treatment of this resident as neglectful. We conclude that the ALJ made no error of law in drawing the inference that sufficient examples of neglect can demonstrate lack of implementation of an anti-neglect policy. We turn next to whether substantial evidence on the record as a whole supported the ALJ's findings of multiple incidents of neglect in relation to Resident 10.
We address in sequence a number of discrete factual matters raised by Emerald Oaks in regard to the ALJ's discussion of Finding 4. In each instance, we consider whether the evidence in the record as a whole contains substantial evidence on which the ALJ could rely to reach the finding in question. If not, we then consider whether that factual finding was material, that is to say, whether substantial evidence remains to support Finding 4 without reliance on the unsubstantiated factual point.
Emerald Oaks argued that the ALJ erred in finding that the resident was admitted with a diagnosis of new onset convulsions, when even the surveyor acknowledged at the hearing that the statement to that effect in the statement of deficiencies was mistaken and the diagnosis was made after admission. Emerald Oaks Br. at 15; Tr. at 102-03. CMS did not dispute that the diagnosis was made after admission based on the seizures which the resident suffered after his stay began. CMS Br. at 12, n.9. It is clear that this diagnosis was not made pre-admission, but rather on re-admission from the hospital after the two episodes at issue. CMS Ex. 15, at 10, 35; Emerald Oaks Ex. 6, at 1. It is not as clear that the ALJ found otherwise. The erroneous statement appears in a section setting out in some detail the allegations contained in the statement of deficiencies regarding the resident. ALJ Decision at 13. Only after that discussion does the ALJ discuss Emerald Oaks's argument and evidence attacking "CMS's recitation of the circumstances relating to Resident 10's decline [as] 'breathtakingly incomplete and misleading'." ALJ Decision at 14-15. The best reading of the language in the decision is that the ALJ recited the mention of the diagnosis as part of explaining the allegations in the statement of deficiencies but did not find as a fact that the diagnosis was pre-admission. This is supported by the fact that the ALJ refers to the resident as having "first evidenced seizure-like activity" in discussing the first episode at the facility, so that she was clearly aware that this was a novel development in his case. ALJ Decision at 15. We therefore do not find any error concerning this point. Even were the ALJ Decision read to contain a mistake about the timing of this diagnosis, we do not agree with Emerald Oaks that the error would be material. Emerald Oaks contended that the pre-existing diagnosis of seizures was the principal basis for the conclusion of neglect because only in that context was there a foreseeable risk. Emerald Oaks Br. at 10. It is undisputed, however, that Resident 10's medical record on first admission included a history of stroke. The ALJ specifically relied on the nurse-surveyor's opinion that the dramatic transient change in Resident 10's vital signs noted at 5:45 AM on October 20th could have reflected a seizure or a stroke in light of the prior stroke history. ALJ Decision at 15. The ALJ made no similar reference to a prior history of seizures. In addition, Emerald Oaks argued that there was no foundation in the record for a reference by the ALJ to a 10-hour delay in hospitalization because the record showed that less than three hours elapsed between the first episode and the second one when the nurse called the physician. The reference appears to be inadvertent error since the times of the two episodes are mentioned earlier in the decision and are plainly close to four hours and not ten hours apart. The point made by the ALJ was that she inferred from the resident's prompt hospitalization when the physician was notified of the second episode that the resident would likely have been hospitalized sooner if the facility had notified the physician of the earlier episode when it occurred. ALJ Decision at 15. The inference need not be the only possible one that could be drawn in order for us to sustain it. We find that it is at the least a reasonable inference and that the reasonableness of the inference is unrelated to exactly how many hours of delay were interposed between the episodes. We therefore conclude that the reference to ten hours was harmless error. Emerald Oaks also contended that the surveyor and the ALJ disregarded evidence that the resident was dying of terminal leukemia, that the surveyor was unaware of this context, and that the resident's resulting rapid deterioration was the real reason for any risks the resident faced rather than any neglect by the facility staff. Emerald Oaks Br. at 15-18. The ALJ rejected Emerald Oaks's assertion that the surveyor did not know the resident was terminally ill with leukemia, citing to the same pages of the transcript as Emerald Oaks relied on for its conclusion. ALJ Decision at 15. The surveyor, who had been a registered nurse for 28 years and had spent seven years in long-term care facilities, did indeed testify that she did not know the resident was dying of leukemia, but she also stated that she "knew the patient was referred to hospice so therefore was probably terminal." Tr. at 142. Emerald Oaks provided no reason why the particular terminal illness diagnosed would alter whether the physician should have been alerted to the resident's abrupt change in condition during the first episode or whether measures should have been adopted to prevent his repeated falls on the evening he returned from the hospital. Clearly, the surveyor and the ALJ were well aware that the facility was handling a very ill patient with a very poor prognosis. Nevertheless, according to Emerald Oaks, no fair conclusion could be reached finding neglect without a full review of the resident's clinical history and evaluation of every intervention which the facility did provide in the course of his decline. Emerald Oaks thus argued that the ALJ improperly ignored documents and testimony it presented to show the facility's "literally hour-by-hour responses to the Resident's declining condition." Id. at 17. Unquestionably, a resident's clinical history and medical diagnosis can often be important in weighing the appropriateness of the care provided by a facility. However, Emerald Oaks pointed to nothing in the law or regulations to support the idea that the entire course of an illness and every instance of correct treatment must be scrutinized and balanced against evidence that neglect occurred during a particular event. An instance of exemplary treatment would not cancel out or make insignificant an instance of gross neglect. Thus, for example, Emerald Oaks noted that on October 18, 2000, the facility contacted the resident's physician about increasing confusion and headache pain and the physician ordered a urinalysis to rule out urinary tract infection. Emerald Oaks Br. at 17. Emerald Oaks then asserted that neither "HCFA nor the ALJ seems to critique this response." Id. It is perfectly true that CMS did not fault this aspect of the resident's care, but that does not undercut the allegation that two days later the staff did not respond appropriately to the new development of sudden unresponsiveness, elevated blood pressure, and other transient abnormal vital signs. Emerald Oaks also described as "sheer speculation" the ALJ's inferences that the failure to alert the physician of the first episode likely delayed the resident's hospitalization and that the risk was much more than minimal because Resident 10 "could have suffered very rapidly from the untreated effects of a seizure or stroke." Emerald Oaks Br. at 19; ALJ Decision at 15. Emerald Oaks argued that Resident 10 had no "signs or symptoms of a stroke" while at the facility but merely had come there having suffered a previous stroke for which his care plan included rehabilitative measures. Emerald Oaks Br. at 19-20, citing Emerald Oaks Exs. 2 and 4, at 1-2. Emerald Oaks incorrectly framed the question of what risks were posed by the nurse's failure to report the initial change in the resident's condition. Emerald Oaks acknowledged that the nurse-surveyor testified that the spike in blood pressure could indicate a blood clot or stroke, but discounted this testimony because Emerald Oaks alleged that the surveyor did not testify that the resident had a stroke or was at risk of one. Id. at 20. The issue the ALJ was addressing in this regard was not how high this resident's risk of stroke was but how serious a potential for harm was created by the failure to notify the physician of the first episode, given the resident's history and symptoms. The ALJ credited the testimony of the surveyor who, as a nurse, testified that the potential was high for clinical harm from delay in notification of a physician in this situation. The surveyor noted in the statement of deficiencies that the episode was brief (the period of disorientation was noted as lasting 20 seconds from when the resident was discovered lying across his bed). Emerald Oaks Ex. 1, at 2. We do not agree with Emerald Oaks that the ALJ's omitting citation to the notations in the nurse's note that the resident stabilized after some time (before having a second similar episode later that morning) detracts from her reliance on the expert testimony presented by CMS about the significance of reporting promptly the abnormal vital signs recorded during the first episode.Emerald Oaks also complained that the ALJ disregarded the subsequent course of the resident's illness, but offered no explanation about why later events would cut against the potential harm of the delay. When taken to the emergency room, the resident suffered a major seizure and the hospital notified the facility that he was comatose and might die within hours when the resident was to be transported back three days later. Emerald Oaks Br. at 21, citing Emerald Oaks Ex. 13 and 19 and Tr. at 456-57. On return, the events transpired which are discussed in the next section involving a series of falls. It is difficult to see anything about these subsequent events that makes it less likely that the initial delay in reporting the first episode presented less risk of harm than was evident from the symptoms that were evident at the time. Furthermore, the later history would obviously not be known to the nurse when she assessed how to respond to the episode so it can hardly be accepted as a reason that reporting the episode was pointless or unnecessary at the time. The only specific evidence to which Emerald Oaks cited to argue that the delay was inconsequential was the response of the facility's medical director, Dr. Harris, to the question of whether the delay of over three hours caused him "any medical concern given what you know about the resident's condition?" He responded as follows; "Given what I know about the resident's condition now, no." Here, again, the testimony on its face relies simply on hindsight to say that given the later course of the resident's terminal illness, this doctor believes he should have been offered only palliative care and not been rushed "back and forth to the hospital so many times," if he "had been taking care of him at the time." Tr. at 227-28. In order to take this approach, Dr. Harris opined that "this case was more about the primary physician sitting down with the family and discuss[ing] end-of-life issues," but Emerald Oaks did not identify any evidence that such a discussion had ever been held or that the resident and/or family did not wish more than comfort care to be offered when new symptoms appeared. Id. In the absence of such a documented plan, the medical director did not assert that the facility could properly make that decision on its own and decide not to report such an abrupt change to the primary physician, nor did the medical director identify any facility policy that had been properly implemented by the nurse in so deciding. Furthermore, the physician who was taking care of the resident at the time ordered him hospitalized immediately on learning of the second episode (and the resident was again hospitalized when he fell soon after his return). It thus appears that the medical director was merely substituting his retrospective view of how he would have treated Resident 10 for the professional approach of the physician in charge of the case at the time. Furthermore, Emerald Oaks's position that it is somehow supportive of its case that, even at the time of the hearing, the surveyor could not say "exactly what was happening" during the episode is not persuasive. See Emerald Oaks Br. at 17. Emerald Oaks stated that it could only be said in retrospect (in light of the multiple seizures the resident later suffered) that the first episode was "probably a convulsion or seizure," and implied that the staff person who found the resident could not have been expected to have known that the resident was seizing. Emerald Oaks Br. at 17-18. Neither the surveyor in her notes or testimony, nor the ALJ, suggested that the staff nurse should have been able to diagnose the cause of the episode as a seizure. On the contrary, the uncertainty presented and the novelty of the symptoms for this resident are part of the reason it was important to notify the physician quickly in order assess the situation and arrive at a diagnosis of what was happening. Since the facility did not notify a physician then, it is hardly the fault of the surveyor that she was unable to determine exactly what triggered the observed symptoms. Emerald Oaks also contended that the nurse on duty exercised reasonable professional judgment because she did not "do nothing" in response to the first episode, but instead gave oxygen and "continued to monitor the Resident closely." Emerald Oaks Br. at 1. Emerald Oaks relies on two notations in the nursing record to establish that the surveyor merely disagreed with the nurse's actual "clinical judgment (to monitor a resident)" for some time "where there is no apparent emergency." Emerald Oaks Br. at 18; see also Emerald Oaks Reply Br. at 14. First, the recorded notes showed that, after reporting the increasing confusion the resident was displaying, the facility had been instructed by the resident's physician on October 18 that it should monitor the resident and "report to MD PRN." Ex. 19, at 1-2. From this Emerald Oaks reasoned that the nurse was to monitor and to use her judgment about whether to report, and that is what she did. We do not find merit in this argument. Emerald Oaks cited no authority for its claim that PRN meant "per nurse's judgment." The term is an abbreviation of the Latin phrase "pro re nata" meaning "as needed," and not derived from per registered nurse as Emerald Oaks suggested. See, e.g., D. Chabner, The Language of Medicine, Glossary at v (2d Ed. 1981). The focus is thus on the needs of the patient, not the discretion of the nurse. That the physician had specifically ordered the nursing staff just two days earlier to watch this resident closely in light of his growing mental confusion and report whenever it became necessary, further supports the basis for a finding of neglect. The essence of the physician's instructions can only be understood to be that the nurses should increase attention to the resident and keep the physician informed of any significant developments. It is unreasonable for Emerald Oaks to attempt to read these instructions as if the nurses were told to only monitor the resident and notify the physician only according to their own judgment. The second point on which Emerald Oaks relied to assert that the nurse properly exercised judgment by monitoring closely is that an entry at 6:10 AM indicates that the resident had stabilized at that point, with no pain or distress. Emerald Oaks Br at 18; Emerald Oaks Ex. 19, at 2-3. That entry is the only indication that any staff checked on the resident after the 5:45 AM episode until he was reported to be found "having generalized seizure" at 8:30 AM. Emerald Oaks Ex. 19, at 3. The absence of any observations for almost 2 � hours after the first episode was resolved does not support Emerald Oaks's claim that the nurse was in fact keeping the resident under close monitoring to evaluate him as an exercise of professional judgment. We find that substantial evidence in the record as a whole supports the ALJ's conclusions that delaying contacting the physician about the sudden changes in Resident 10's condition and his abnormal vital signs until a second episode occurred demonstrated a failure to implement an effective anti-neglect policy and that the delay presented a potential for more than minimal harm.
Emerald Oaks also sought to reinterpret several factual matters relating to the events that occurred after Resident 10's return from the hospital. First, the facility asserted that the record showed that the resident was returned to the private room in the suite he occupied before his hospitalization because the family requested it. Emerald Oaks Br. at 21-22. Also, Emerald Oaks contended that, contrary to the ALJ's findings and despite the fact that he was found on the floor three times the night he returned, the resident was adequately monitored in that nursing notes showed he was checked at least once an hour that night. Emerald Oaks Br. at 22. Also, Emerald Oaks pointed to a variety of evidence in the record about the steps it took the next morning to notify the physician, to reassess and plan new interventions (such as ordering a low bed), and to move the resident to the nursing station for easier observation. Emerald Oaks argued that CMS's case was defective because CMS did not identify the specific omission that constituted neglect in relation to the falls. Instead, according to Emerald Oaks, CMS shifted from one event to another as a possible justification for finding neglect - for example, sometimes pointing at the room location, sometimes to the surveyor's observations of the resident's difficulty rising from his chair and chewing on plastic, sometimes to the falls, without balancing these incidents against the appropriate responses of staff. See, e.g., Emerald Oaks Reply Br. at 15-16. Rather than disputing the facts that the ALJ recited, Emerald Oaks largely emphasized certain facts which Emerald Oaks felt were essential to weighing whether Resident 10 was neglected on his return from the hospital. Emerald Oaks emphasized that, on the morning of October 24, 2000, the staff undertook to plan numerous interventions to address the overnight falls and prevent further ones. Emerald Oaks Br. at 23-24. Further, Emerald Oaks stated that the surveyor "actually conceded that Emerald Oaks's various assessments and interventions generally were appropriate and timely." Emerald Oaks Br. at 24, citing Tr. at 155-60, 163. It is true that CMS did not contest that the planned interventions were appropriate, but neither the ALJ nor CMS agreed that they were actually or timely performed. As Emerald Oaks itself noted, neither CMS nor the ALJ treated the first fall which Resident 10 experienced when he returned from the hospital as evidence of neglect. Emerald Oaks Br. at 21. The facility was not found to be on notice at that point that Resident 10 was at greatly increased risk of falls,(9) since Emerald Oaks's administrator had been informed by the hospital that the resident would be arriving comatose and near death. Tr. at 456-57. The situation was significantly different when the resident was brought back from the hospital the second time 10 hours later. The facility then had notice of and time to plan for the new risk of falls for this resident.(10) The resident was returned to the same private room out of view of the nursing station. The only new interventions noted in the record were the use of a "Tabs unit" to alert staff if he attempted to transfer from bed without help and plans for an hourly check. Emerald Oaks Exs. 1, at 3; 19, at 5. At 3:30 AM and again at 5:30 AM, the resident was found on the floor, the Tabs unit having been disconnected. The nursing notes state that hourly checks would be continued, but no added measures or increased supervision are recorded, despite this clear indication that the Tabs unit and hourly checks were insufficient to prevent repeated falls.(11) Only at eight in the morning did the facility contact the resident's physician and family to notify them of the falls. The facility then engaged in care planning and identified a number of interventions, including moving the resident closer to the nursing station, installing a bed alarm, and ordering a special low bed, as well as seeking family consent and physician orders for bed rails and a "lap buddy" to reduce falls. See Emerald Oaks Br. at 23, and exhibits cited therein. However, despite Emerald Oaks's characterization of this as an immediate response, no plans for specific interventions were made until many hours after the first fall. Emerald Oaks did not explain why actions that could be implemented by the facility on its own authority (such as the location change and increased monitoring) were not undertaken more quickly, nor why physician orders and family consents were not sought immediately where needed for other measures to be implemented. Furthermore, one significance of the surveyor's direct observation of the resident on October 25, 2000 is that even at that point the recorded interventions were not actually being implemented effectively. The resident remained in the room in the pod away from the nurse's station. Tr. at 114. The Tabs alarm remained on the bed disconnected while the resident was sitting without an alarm in a straight chair (not a wheelchair in which the lap buddy could have been employed). Tr. at 105-14. The surveyor observed him trying to rise without assistance and banging his head on the wall and chewing on what proved to be a piece of plastic. Emerald Oaks responded that, while admittedly the object presented a risk of choking, the facility had no notice that the resident was likely to put things in his mouth. Emerald Oaks Br. at 29. While that particular action may well have been unpredictable, the act evidences the many risks presented by inadequate supervision of this resident. Emerald Oaks acknowledged that the resident did have a history of "sitting down suddenly," for which he was getting physical therapy, so it is hard to see to how the risk of his hurting himself left unrestrained and without either observation or alarm could be called unforeseeable. Cf. Emerald Oaks Br. at 28-29. This admitted risk of falls is not mitigated by the absence of testimony that the resident was also "unsafely seated in the chair." Emerald Oaks Br. at 16. Nor are we persuaded by the argument that the surveyor was to blame herself for screaming for help (without leaving the resident alone) and thereby purportedly causing him to fall backward while trying to rise by interrupting or startling him. Id. The situation in which the resident was found, despite having already fallen four times in 24 hours, and the fact that he fell back into the chair and hit his head the first time demonstrated the absence of adequate measures to protect the resident, regardless of how the surveyor proceeded in seeking help for him. Emerald Oaks argued that neither CMS nor the ALJ specified what precise measures it should have taken to avoid neglect charges or which of its interventions were inappropriate, but instead engaged in hindsight to find fault. See, e.g., Emerald Oaks Br. at 24-25. The Board has explained in past decisions that the regulatory approach taken in regard to long-term care facilities is to grant leeway to facilities to choose the best means to attain the required conditions.
Woodstock Care Center, DAB No. 172, at 28 (2000). We conclude that it was appropriate for the ALJ to evaluate whether the actual measures implemented by Emerald Oaks to respond to Resident 10's changing needs were reasonably calculated to forestall the emerging risks, rather than to provide a checklist of what steps should have been taken.
Emerald Oaks made several overarching characterizations of the case against it that deserve to be addressed independently of the specific disputes discussed above. For example, Emerald Oaks argued that CMS and the ALJ were disrespectful of the efforts of its professionals to "provide for the comfort and safety of this dying resident" and "trivialize[d] the regulatory concept of 'neglect'" by basing this deficiency finding on after-the-fact hindsight about what other steps might have been taken without showing that what was done violated some specific regulatory requirement or professional standard. Emerald Oaks Br. at 25. This, Emerald Oaks argued, amounted to the application of a "notorious 'zero tolerance' standard" for anything short of "every surveyor's subjective idea of perfection." Id. This resident, according to Emerald Oaks, was "at risk for all sorts of bad consequences as the result of his deteriorating medical condition, not any act or omission by Emerald Oaks". Id. Any risk from the sequence of events alleged by CMS was hypothetical. Id. at 29. The evaluation of the seriousness of the potential for harm from an instance of neglect does not depend on whether the harm is realized or whether the role played by the failure to take needed action can be disentangled from other contributing causes. If, as here, a resident who has had seizures is not protected from falls and blows to the head, it is evident that further injuries may occur. It is not essential whether further or more severe seizures actually followed the falls or, if so, whether these seizures were "caused" by the blows to the head or by the underlying illness. Were it otherwise, facilities could with impunity neglect or mistreat the terminally ill in a manner that could hasten their deaths or increase their suffering beyond the unavoidable, and then argue that the residents were sure to die regardless so that any harm that might or did transpire could not be proven to derive from the neglect as opposed to the course of terminal illness. We also reject Emerald Oaks's contention that the ALJ engaged in a kind of circular reasoning, concluding that the resident must have been neglected since his condition declined and that the decline must therefore have been caused by neglect. Emerald Oaks Br. at 16. On the contrary, the ALJ relied on specific instances in which she found that staff failed to respond to the resident's needs, whether or not those needs resulted from leukemia, stroke, or other causes. It is not an adequate response to assert that many other things were done for the resident at other times. Nor does the fact that the resident was terminally ill reduce the requirement that he be protected from neglect. If anything, his evident fragility and instability called out for more attentive care to respond to the rapidly changing needs of what Emerald Oaks itself described as his deteriorating condition. Emerald Oaks also made a number of generalized assertions about what different view of the case might emerge from a review of the complete clinical record of this resident. We have reviewed the record before the ALJ as a whole in making our determination that, taken together, the evidence supporting the ALJ's finding meets the test as substantial. Nevertheless, the burden was on Emerald Oaks to point us to any particular documents or testimony that, in its view, contradicted the finding. It is not sufficient for Emerald Oaks to attack the ALJ Decision by complaining that its evidence was not given enough weight or not discussed enough. Emerald Oaks must identify specific evidence that it claimed the ALJ disregarded and explain why that item undercuts the evidence on which the ALJ reached a determination. Emerald Oaks was specifically instructed to this effect in the letter of instructions it was sent, after its appeal to us, which stated in part: "You should include precise citations to the record before the ALJ where appropriate." Board Acknowledgment Letter at 1. We reject as unsupported those broad complaints made by Emerald Oaks about the ALJ's treatment of its evidence which were not supported by any specific record citations. We conclude that substantial evidence in the record as a whole supports the ALJ's Finding 4, and we therefore affirm it in full.
3. Emerald Oaks's exception to Finding 5 is without merit. Emerald Oaks excepted to the ALJ's Finding 5 which read as follows:
ALJ Decision at 16 (bold in original). This deficiency finding was based on interviews with the resident's family who complained that the resident had been left unattended on two occasions in her own feces and after a nosebleed. ALJ Decision at 16-17, and record exhibits cited therein. The ALJ rejected Emerald Oaks's assertion that the citation was "trivial" but agreed with Emerald Oaks that the account of events reported by family members was uncorroborated hearsay. Id. at 17. She noted that the hearsay had some reliability in that the resident at issue was identified in the statement of deficiencies so that the facility had the ability to test the accuracy of the report of the family's statements. Id. Also, she noted that the facility's record of grievance filed by the son and daughter corroborated their complaints. Nevertheless, the ALJ concluded that she did not find a deficiency sufficiently shown by those statements alone because CMS did not seek corroborating evidence of a problem with handling of incontinent residents or show that the treatment of this resident, even if unpleasant in the manner reported, presented a potential for more than minimal harm. Id. at 17-18. Emerald Oaks argued that, even though the ALJ concluded that CMS had not substantiated the deficiency finding, we should review and "set aside" the ALJ's discussion of the facts because it considered the description of evidence and the inferences drawn therein to be unsupported by the record and to "reflect poorly on Emerald Oaks." Emerald Oaks Br. at 30. Even were we to make corrections to any misstatements in the ALJ's discussion, the facility would receive no meaningful relief, since the facility already prevailed on the ultimate conclusion on this deficiency. Much of what Emerald Oaks cited merely fleshed out details of the resident's case and course of care during her brief stay, without affecting the accuracy of the ALJ's subsidiary findings, or consisted of unsupported claims. Emerald Oaks failed to demonstrate that any alleged error in the ALJ's discussion had any material effect on the outcome of the Decision or the imposition of remedies, especially given the mandatory nature of the termination. We therefore find no reason to address the individual objections that Emerald Oaks raised to the phrasing of the ALJ discussion. We thus find no merit in Emerald Oaks's arguments concerning Finding 5 and decline to revise the ALJ's discussion or findings. 4. Emerald Oaks's exception to Finding 6 is without merit. Emerald Oaks excepted to the ALJ's Finding 6 which read as follows:
ALJ Decision at 18 (bold in original). The statement of deficiencies reported that interviews with the resident and three family members reported repeated episodes in which the resident was left soaked in urine for long periods and was not showered regularly. Emerald Oaks Ex. 1, at 5-6. The ALJ found that these conditions presented a risk of more than minimal harm not only in terms of indignity but also in that the resident's care plan identified her as high risk for impaired skin integrity due to incontinence. ALJ Decision at 18; CMS Ex. 16, at 17. In addition, CMS cited an episode on October 26, 2000 in which the resident sustained a head wound requiring sutures in a fall in the bathroom. Emerald Oaks Ex. 1, at 6. This resident's daughters testified at the hearing that their mother said that she fell in the shower and that the aide told them that their mother fell because the aide, unable to locate a shower chair, had attempted to shower her standing with her walker. ALJ Decision at 19; Tr. at 179-184, 199-201. The ALJ found that Emerald Oaks was on notice about the need to take special care to prevent falls for this resident because of her weak legs and the care plan had identified this high risk and planned to "[m]onitor for safety and steadiness" and "[e]ncourage use of assistive device when ambulating." ALJ Decision at 19; CMS Ex. 16. Based on these findings, the ALJ concluded that Emerald Oaks's treatment of Resident 12 amounted to neglect. ALJ Decision at 20. Emerald Oaks argued that the evidence it presented should have sufficed to prove that none of the hygiene complaints was substantiated and the injury in the bathroom occurred when the aide followed the request of the family by leaving her in privacy on the toilet and not in the shower at all. Emerald Oaks Br. at 35-36. The evidence to which Emerald Oaks pointed showed a series of assessments and interventions to address the resident's incontinence and diagnosed neurogenic bladder. Id. at 36-37; Emerald Oaks Exs. 56, 58-61, 63. Also, Emerald Oaks alleged that the ALJ disregarded a shower log which contradicted the family's complaints about inadequate showering, including showing a shower the day before a birthday visit at which the family said they found her so filthy that one relative showered her. Emerald Oaks Br. at 38; Emerald Oaks Ex. 73, at 2. The exhibits cited by Emerald Oaks do demonstrate active planning for the incontinence, especially in July and August of 2000. After that, all that appears is a reference in a summary from September 2000 to the fact that the resident requires some assistance with toileting due to her neurogenic bladder. Emerald Oaks Ex. 63, at 1. None of the documents directly contradicts the daughters' testimony about how slowly staff responded to the actual incidents of incontinence. Apparently this family was difficult for Emerald Oaks to deal with, since Emerald Oaks remarked that they "complained almost constantly."(12) Emerald Oaks insisted on the position that "family complaints alone cannot ipso facto support a deficiency . . . without any corroboration," despite the distinction that these family members testified in person so that no hearsay issue was present. The ALJ was in the best position to determine the credibility of the daughters' reports of their mother's care, and it is evident that the ALJ found them believable. Emerald Oaks repeatedly implied that such "family complaints" are somehow inherently questionable. See, e.g., Emerald Oaks Br. at 31, 35. Emerald Oaks demonstrated a pattern of disparaging the reports of family members or residents. For example, Emerald Oaks argued in its discussion of Finding 5 that its own investigation disproved family complaints. Emerald Oaks Br. at 33. A review of the investigative report, however, flatly disproves this argument. The facility's own investigation found that the nurse involved "revealed" in an interview that she "(1) left medication in res. room without making sure res. took meds, (2) prevented son from coming in the room and (3) when asked by son to help mother refused stating she was already late with her med pass." Emerald Oaks Ex. 43, at 1. Further, the ALJ reasonably inferred that the investigation corroborated the inadequacy of the care, given that the "DON called owner of agency re: disciplinary action for this nurse and asked never to send her to our facility again. Nurse put on our 'Do not accept' list of agency personnel." Id. We disagree with Emerald Oaks that somehow the testimony of family members is inherently less credible or reliable than facility staff testimony or records. We do not suggest that all family complaints are well-founded or that all family members should be credited uncritically, only that the credibility and probative value of testimony by family members are to be assessed by the ALJ no differently than that of other witnesses. We also note that Emerald Oaks elected not to cross-examine the daughters who voluntarily testified. Furthermore, the record shows that the family's complaints here were corroborated to some extent by the facility's own records. For example, some of the care planning for incontinency was done in response to a family grievance filed October 9, 2000 that their mother was capable of daytime continence if regularly toileted, but was not being adequately attended to. Emerald Oaks Ex. 12, at 1. In response, the facility then undertook to assist her to the restroom in the morning and evening and before and after each meal and as needed. Id. at 1-6. The grievance form shows that the family's concerns were consistently expressed contemporaneously, and the follow-up plan does not indicate that the concerns were unfounded.(13) We turn next to the fall which resulted in head lacerations.(14) Here, there are two distinct versions of the events. Emerald Oaks contends that the resident "almost certainly" did not fall in the shower for lack of a shower chair but rather "fell from her toilet before her shower;" and further asserted that this difference "should determine whether the incident was a deficiency." Emerald Oaks Br. at 39. Emerald Oaks further argued that, even if CMS's version were true, the most that could be found is that one aide misjudged one resident's need for a shower chair, not that neglect by the facility occurred. Emerald Oaks Br. at 39, n.26. Emerald Oaks admitted, however, and its own records show that the facility was aware that this resident was at risk for falls in the shower (and that she needed a shower chair). Id. at n.27; Emerald Oaks Ex. 53, at 10-11; see also Tr. at 184-85, 200, 616-618; CMS Ex. 16, at 18. Emerald Oaks's essential arguments rest on two theories: (1) the resident lied to her daughters about how she fell because she wanted them to take her home and thought blaming the aide would facilitate that, and (2) the aide consistently told the truth to the facility administrator when she investigated the fall. Emerald Oaks Br. at 40-43, n.29. Emerald Oaks denied that the aide ever told anyone any other story about the incident, and asserted that the ALJ's finding to the contrary was without any record support. Id. at 40-42, n.28. To bolster this claim, Emerald Oaks quoted a portion of the testimony of each of the daughters in which they reported the nurse's aide apologizing profusely but reporting that the fall occurred when she left their mother on the toilet and stepped away to fetch dry clothes. Emerald Oaks Br. at 41-42; Tr. at 180-81, 200. The selected excerpts delete the very portions of the transcript in which the daughters assert precisely what Emerald Oaks denied was in the record - that is, an allegation that the aide did indeed tell them otherwise. Specifically, one daughter stated that --
Tr. at 184. Thus, the daughters relied not only on their mother's report but on the aide's contemporaneous admission. The testimony of the daughters and the facility administrator directly conflicted as to whether the location of the blood stain in the bathroom indicated the fall was from the shower or the toilet. Compare Tr. at 185 with Tr. at 524-28. We defer to the ALJ's determination that the daughters' testimony as to how the fall occurred was more credible. Emerald Oaks also argued that a contemporaneous shower log entry for that date, which reads "patient fell, shower not done," is probative that the fall must not have occurred in the shower. Emerald Oaks Br. at 42; Emerald Oaks Ex. 73, at 1. This note was entered by the same aide whom the daughters testified told the administration one version while admitting a different scenario to them. If the ALJ found this report by the daughters credible, it would follow that the aide might well enter an exonerating note in the shower log to buttress her position with the administration. The brief entry is also ambiguous. It could be read that no shower was undertaken because the resident fell beforehand from the toilet, but it could also be read that no shower was accomplished because the resident fell in the shower before she could be fully washed. We therefore do not find that this document detracts from the existence of substantial evidence in the whole record which is sufficient to sustain the ALJ's finding. We affirm Finding 6. 5. Emerald Oak's exceptions to Findings 7-9 are without merit.(15)
The ALJ found in the following FFCLs that Emerald Oaks had violated the participation requirement at 42 C.F.R. � 483.20(k)(3)(i) with regard to three residents identified by the numbers 5, 8, and 10:
ALJ Decision at 20, 22, 23 (bold in original). The regulatory requirement for which the facility was cited in each case reads as follows:
42 C.F.R. � 483.20(k)(3)(i). In each finding, the ALJ concluded that an aspect of the care of one resident evidenced a failure to meet the relevant professional standard for quality of care. In the case of Resident 5, the ALJ determined that the facility had failed to correct problems in its medication delivery system revealed in the previous survey, based on the fact that two medication amount errors went undetected despite instituting new systems to catch errors. ALJ Decision 20-22. In addition, the ALJ found that no results from lab tests ordered by the resident's physician were entered in the resident's chart. Id. The professional standard implicated was the basic requirement that nurses must follow physician orders. In the case of Resident 8, the ALJ found that a tube feeding bag was left in use for more than 24 hours, violating a nursing practice standard calling for more frequent changes to prevent bacterial contamination. Id. at 22-23. In the case of Resident 10, an emergency room physician ordered phenobarbital to be given at hour of sleep to control breakthrough seizures, but the facility added it to morning medications because a discharge sheet said only to give it daily. Id. at 23-25.
Before addressing the specific factual bases for each of the findings, we first consider Emerald Oaks's overarching arguments about this requirement. Emerald Oaks argued that CMS treated the "professional standards 'tag'" as a "catchall" to cite a set of facts that fails to support any more specific deficiency finding with the result that "any surveyor's subjective judgment - in this case regarding the interpretation of a regulation! - in itself can support a deficiency." Emerald Oaks Br. at 46, 48; see also id. at 5. Emerald Oaks also asserted that, as to all the "alleged errors themselves, the evidence demonstrated that all were trivial and none exposed any Resident - especially Resident # 5 - to any risk of harm whatsoever." Id. at 48. CMS denied the various formulations attributed to it by Emerald Oaks to suggest that CMS was stretching to cite insignificant matters. Thus, CMS denied that it ever stated "that 'substantial compliance' is fluid, that a 'zero tolerance' standard exists, or that deficiencies arise from care that is 'less than perfect in the surveyor's opinion.'" CMS Br. at 4, n.3, quoting from Emerald Oaks Br. at 3-5. In any case, the ALJ's job was to determine whether the facts as shown by the preponderance of the evidence show a failure to comply with the cited regulatory requirement in a way that presented a risk of more than minimal harm. If the facts in evidence do not fit the regulation cited, the deficiency finding will not be upheld. See Woodstock Care Center, DAB No. 1726 (2000). Neither the requirement to provide services meeting professional standards of quality (nor the requirement discussed in earlier sections to develop and implement appropriate policies, as Emerald Oaks also suggested) provides for a miscellaneous or catchall category of fault-finding, as Emerald Oaks complained. Rather, these broad statements of expectations reflect the overall focus of the regulatory scheme in articulating what the facility is expected to provide to residents. Facilities thus retain the flexibility to achieve those expectations in a variety of ways but are held accountable for care that falls short of applicable professional standards. In any case, regardless of the formulation in which CMS may have framed its allegations, nothing in the ALJ Decision demonstrates to us that the ALJ departed from the applicable regulatory standards. It is, of course, unavoidable that a surveyor on the scene of a facility makes some judgments about what to attend to, how to assess various sets of facts, and whether a situation is serious enough to require a citation. CMS therefore provides training to surveyors in how to apply and interpret federal regulations in their work. 42 C.F.R. � 488.314(b). The interpretation of the regulations does not ultimately lie with the surveyor, however. CMS reviews and makes independent decisions on surveyor determinations. If CMS's interpretations or applications are challenged on appeal, the ALJ reviews the meaning of the regulation by the usual means of legal interpretation. We find that the ALJ did precisely what Emerald Oaks argued that she should have done, i.e, made the determination on each deficiency "turn on proper application of HCFA's regulations," and did not simply defer to the surveyors. Emerald Oaks Br. at 48. In addition, Emerald Oaks repeatedly framed this case, and particularly these deficiency findings, as balancing a trivial error against a "death penalty" termination remedy. For example, Emerald Oaks characterized the ALJ as concluding, in relation to the feeding bag left in place more than 24 hours, that "this single deviation from a facility policy represented a violation of a professional standard . . . sufficient to terminate" the facility. Emerald Oaks Br. at 55. This repeated theme evidences a failure to understand the approach to survey and remedy enforcement in the Act and regulations. In the case of Emerald Oaks, termination was not selected based on an exercise of discretion by CMS but was directly mandated by the Act. Section 1919(h)(3)(D) of the Act; 42 C.F.R. �� 488.412(d), 488.450(d). The Act requires termination of any provider who has failed to achieve substantial compliance for six months. Emerald Oaks reached that point on October 30, 2000. Obviously, therefore, there is no question in this case but that the termination remedy was not imposed as a result of any single "error" but as a result of multiple deficiency findings over a prolonged period. To whatever extent termination constituted a death sentence for Emerald Oaks, the facility had multiple opportunities to avoid it. A remedy is imposed, in any case, based on survey findings that, taken together, demonstrate a lack of substantial (not perfect) compliance with participation requirements. The selection of a remedy is based on a regulatory system "built on the assumption that all requirements must be met and enforced and that requirements take on greater or lesser significance as a function of the circumstances and resident outcomes in the facility at the time of the survey." 64 Fed. Reg. 13,354, at 13,355 (March 18, 1999). Once a facility has been found not to be in substantial compliance with the requirements, that is to say, having any deficiencies which present a risk greater than the potential for minimal harm, CMS has discretion to select an appropriate remedy, whether termination and/or alternative remedies, and the exercise of this discretion is not subject to ALJ review.(16) Section 1919(h)(3)(B); 42 C.F.R. � 488.408(g)(2). The Board recognized this principle in a prior case, holding as follows:
Beverly Health and Rehabilitation - Spring Hill, DAB No. 1696, at 12 (1999). We conclude that Emerald Oaks's assertions that termination was a disproportionate remedy are inapposite. Termination was available to HCFA as a remedy once Emerald Oaks was shown to be out of substantial compliance. Once that noncompliance had persisted for 6 months, termination was not discretionary but mandatory.
There were two parts to the allegations relating to Resident 5, who arrived at the facility after her September 29, 2000 discharge from the hospital for gastro-intestinal bleeding. CMS Ex. 13, at 31-33. Her hospital physician ordered that the facility "hemoccult all stools" and "notify MD, if gross bleeding." Emerald Oaks Ex. 31. He also ordered two medications to be administered: 10 mg. of Aricept once a day and 500 mg. of Calcium twice a day. The resident left the facility on October 2, 2000. The first problem that the ALJ found was that no hemoccult test results were present in the resident's records. ALJ Decision at 22. The ALJ found that the facility documented seven stools during the resident's brief stay, and three stool samples taken on the final day, but no evidence that any stool sample was tested or sent to an outside laboratory for testing. Id. and record citations therein. Emerald Oaks never pointed on appeal to a hemoccult test result overlooked by the ALJ. Instead, Emerald Oaks argued it proved that it collected samples and that its administrator testified that she saw stool samples from this resident at the nursing station on October 1, 2000 awaiting laboratory pickup. Emerald Oaks Br. at 49. This hardly undercuts the finding since the facility's responsibility was not merely to collect samples (and that sporadically) or even to send them out, but to obtain results and review them for bleeding. Emerald Oaks also argued that the resident ran no risk of injury because there was no evidence that she was bleeding and that, since the resident left on October 2, 2000, any results from October 1 and 2 would have been academic. Id. at 50. The fact that no results appeared is not academic because clearly, even if some results arrived after the resident was discharged, collecting the information as to the pattern of any possible gastro-intestinal bleeding during her stay was the facility's responsibility and could have revealed an emergency condition. Finally, Emerald Oaks's medical director speculated that iron supplements might have caused unreliable hemoccult results, noted other tests results for the resident that were normal, and pointed to other appropriate care that the facility did provide to this resident. None of this detracts from the finding that failing to perform and obtain results of hemoccult tests as ordered placed the resident at risk of undetected bleeding. The second problem was that the medication orders were reversed in entering them into the facility computer system, so that the resident would receive two doses of Aricept and one of Calcium daily. See CMS Ex. 13, at 6-16.(17) The error carried over from the September to the October computer printout of medication orders. Id. Emerald Oaks emphasized that these two errors did not meet the standards for citations for excessive medication error rates, which are based on sampling medication passes to assess whether the error rate exceeds five per cent. 42 C.F.R. � 483.25(m). In particular, the surveyors did not review other charts and, therefore, could not determine an error rate. Emerald Oaks Br. at 53-54. Emerald Oaks also suggested that, because of the resident's admission and discharge right at the juncture of two months, hers was "literally the only one in the entire facility that was not audited in the monthly audit on Monday, October 2," which was part of the facility's quality assurance system for catching medication errors. Id. at 53; Tr. at 567-71. The allegation here was not that Emerald Oaks had an excessive medication error rate at the October survey. The deficiency involved a repeated failure to institute systems effective to carry out medication orders professionally. Emerald Oaks had not contested a deficiency finding at the August survey that Emerald Oaks had failed to properly record and carry out medication orders. CMS Ex. 10, at 4-5.(18) In its plan of correction, Emerald Oaks asserted that it had implemented a "[d]aily chart check system . . . to assure all physicians orders are pulled and carried out timely.". Id. at 4. In addition, an audit tool for reviewing physician's orders was reportedly implemented on September 18, 2000. Id. at 5. Facility nurses reported to the surveyor that daily chart checks were being carried out, even on weekends. CMS Ex. 11, at 11-12. Not only were the orders both entered improperly into the system, but, most significantly, the printed orders were counter-signed on different days by three different staff members to verify the accuracy of the contents without anyone catching the error. CMS Ex. 13, at 8-11, 13, 16. The ALJ reasonably inferred that the persistent failure of Emerald Oaks to prevent or catch medication errors indicated a systemic failure. ALJ Decision at 21. Nothing in the testimony referenced by Emerald Oaks undercuts this inference. Nor are we persuaded by the claim that this chart was uniquely omitted from the audits because of the unusual timing of the resident's stay. First of all, if that were the case, it would simply disclose a flaw in the audit system. Second, the record indicated that the incorrectly-entered orders were reviewed and signed off on by nurses under the quality control system and still went uncorrected. Tr. at 331. The ALJ did not, as Emerald Oaks asserted, impose an unattainable goal that "a nurse must never make an error, no matter how minor." Emerald Oaks Br. at 54. Instead, the ALJ found that the recurrence of medication errors, despite Emerald Oaks's assertion that it had corrected its problems with administering medicines and had put in place a back-up mechanism, meant that Emerald Oaks could not assure that residents would receive the medications ordered by their physicians from the facility nurses, and that this condition violated the professional standard that nurses must carry out physician orders. ALJ Decision at 21-22. We also agree with the ALJ that the absence of physical harm to Resident 5 as a result of the brief mix-up in dose is not dispositive of the risk to residents presented by this systemic failure. See id. at 22. We find that substantial evidence in the record as a whole supports the ALJ findings regarding Resident 5. We therefore affirm Finding 7.
The allegation regarding Resident 8 was that the bag used to administer artificial nutrition was found at noon on October 25 during the survey to be dated October 23. Based on their knowledge about and experience of general nursing practices, as well as information about the policy and practice at this facility, the surveyors concluded that the bag had gone unchanged for more than 24 hours. CMS alleged, and the ALJ found, that professional nursing standards based on an authoritative text required bags to be changed every 24 hours to control the risk of bacterial infection. The facility itself had a policy to change the bags every 24 hours. Tr. at 224 (Dr. Harris). Emerald Oaks argued that the bags were changed just before midnight, so the October 23rd notation reflected a change just before midnight that day. Emerald Oaks suggested that what had happened was that "a temporary agency nurse" on duty October 24 had forgotten to change the bag. Emerald Oaks Br. at 55. Thus, Emerald Oaks disputed the ALJ's finding that the bag was not changed for more than 48 hours. This dispute is irrelevant. The nursing standard called for a change within 24 hours and, even under Emerald Oaks's scenario, the deadline was exceeded by more than 12 hours. The second point advanced by Emerald Oaks is that the ALJ should have made findings about just how long it would have taken for the risk of food-borne illness to be realized. Emerald Oaks at 56. In that regard, Emerald Oaks relied on testimony from its medical director to the effect that the 24-hour rule incorporated a large margin of error and that even at 36 hours the risk was remote. Tr. at 221-24. He did note, though, that he would want to discipline "a CNA or whoever was involved in it to make sure they followed our policy," even though the time involved would not give him "any undue concern." Tr. at 224. Just as Emerald Oaks would enforce its policy, so CMS enforces professional standards of nursing. There is no real question that they were violated here. Again, the resident involved did not suffer actual harm, but there was obviously some risk that bacterial food-borne infection could occur. Dr. Harris essentially suggested that, if you accepted the lowest range of possible delay, the risk of infection was small. Tr. at 223. We do not find this sufficient to overcome the evidence in the record on which the ALJ relied to find that the resident's feeding bag was allowed to sit unchanged long enough to present more than a minimal risk of illness. We therefore affirm Finding 8.
This allegation involved the same resident who was hospitalized after developing seizures and who was discussed in relation to Finding 4. On return from the hospital, the resident was prescribed phenobarbitol by the emergency room physician to add to his medication regime to control breakthrough seizures. The physician progress note instructed that 60 mg phenobarbitol be administered at hour of sleep (HS). ALJ Decision at 24; Emerald Oaks Ex. 24; Emerald Oaks Ex. 1, at 8. A discharge instruction sheet simply ordered that the resident receive one tab daily. ALJ Decision at 24; Emerald Oaks Ex. 23. The facility nurse was in the process of including the phenobarbitol in the resident's morning medication pass, along with another seizure medication which he had been taking, in accordance with facility practice scheduling daily medications for 9 AM administration. ALJ Decision at 24; Emerald Oaks Ex. 1, at 9. The surveyor intervened; the medical director was contacted; and the medication was rescheduled for bedtime. Id. CMS alleged and the ALJ held that the failure to seek clarification to resolve the inconsistency regarding the proper hour of administration represented a failure by the facility's nurses to take action to ensure that physician's medication orders are carried out correctly. ALJ Decision at 24-25. CMS presented testimony from a surveyor with nursing expertise that clarifying ambiguous orders regarding patient care is a professional responsibility of nurses. Tr. at 125. Emerald Oaks argued that the testimony of its medical director contradicted the testimony of a surveyor who expressed concern that giving the two medications in the morning might increase the risk of breakthrough seizures at night. Emerald Oaks Br. at 62, citing Tr. at 127-28, 619. Emerald Oaks also cited the medical director's testimony denying the report in the statement of deficiencies that, when contacted, he had considered the ambiguity about timing to be a serious issue. Emerald Oaks Br. at 64-66, quoting Tr. at 234-37. A review of the medical director's testimony shows that he was much less direct than Emerald Oaks suggested in disputing the nature of his conversation. Thus, for example, he indicated that he understood the surveyor to be concerned about whether it was dangerous to administer the two medications together, that he did not "say, no they are not dangerous," but agreed to have the phenobarbitol administered at night because "sometimes you pick your battles," because he thought it was a "trivial item," and because he did not think that administering the two together presented a danger "unless they're very high doses . . . but in this particular case it was not of concern." Tr. at 235-37. From this vague account, it seems possible that the surveyor received the impression that the medical director agreed with her that the phenobarbitol should have been administered at night and that the difference could be serious, while he may have felt at the time that it was an insignificant matter. The ALJ did not directly resolve this dispute, although it appears that she gave more credence to the surveyor's report. In any case, contrary to the focus placed on this by Emerald Oaks, CMS did not rely on a potential hazard from co-administration or suggest that the nurses should have questioned an order to co-administer them. For that reason, it is not surprising that Dr. Acker,(19) appearing as an expert witness for CMS, did not dispute that they can be safely administered together. Rather CMS challenged the nurse's failure to contact the physician before determining that the medication which he ordered for bedtime for this resident (on one form) could be changed to morning. (The ALJ referred to this as failure to clarify inconsistent orders but it could be treated as simply failure to follow orders, since the discharge form did not order morning administration but was silent as to the time of day to give the medication.) The order involved was not that of Dr. Harris (the medical director). His comment that "if it were up to me, it wouldn't make a difference" when the phenobarbitol was administered, because the dilantin was a long-acting medication, does not directly address whether the nurses should have sought clarification before varying from the time ordered by the physician involved. See Tr. at 234. Further, he did not address the concern that dual administration in the morning could mean that the therapeutic effect of the phenobarbitol (uncontestedly short-acting) would be ineffective in controlling night seizures. Emerald Oaks argued repeatedly that the professional opinion of the treating physician should have been credited when the conflicting testimony came only from surveyors' opinions.(20) See, e.g., Emerald Oaks Reply Br. at 9. Here, however, that is simply not the issue. Dr. Harris was not the treating physician. The surveyor and supervisor testified based on their own professional expertise, not about whether the physician's orders were right but about whether the nurses violated standards of nursing care by not either following or clarifying the orders. Emerald Oaks also argued that it had shown that the standard of practice in Sarasota, Florida is to treat only the patient discharge instructions as the relevant physician orders, without regard to any information, even about medication orders, contained in the physician progress notes. The testimony on which Emerald Oaks relied amounted essentially to statements that the discharge instructions are common and the document in which these orders were embodied is not. Nothing cited by Emerald Oaks established that, where inconsistent physician orders are found in two documents, the familiar one should be implemented and the unfamiliar one ignored under any local practice standard. It is difficult on this record to assess the exact magnitude of the risk that the deviation from the order to medicate at bedtime presented for this resident. Even balancing the evidence referenced by Emerald Oaks to minimize the risk of harm, however, does not undercut the ALJ's conclusion that the risk was greater than the potential for minimal harm. We affirm Finding 9.(21) CONCLUSION Based on the above analysis, we sustain the ALJ Decision in its entirety and affirm Findings 1 - 9. |
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Marc R. Hillson M. Terry Johnson Donald F. Garrett |
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1. The Health Care Financing Administration (HCFA) has been renamed the Centers for Medicare & Medicaid Services (CMS). See 66 Fed. Reg. 35,437 (July 5, 2001). Since "HCFA" was used to refer to the agency at the time that many of the actions at issue here were taken, some references from documents and testimony use the old acronym. 2. In its notice letter to Emerald Oaks imposing the CMP, CMS stated that it had "considered factors identified at 42 CFR 488.438(f) in setting the amount of the CMP," but did not provide further detail as to the evidence it reviewed or the weight it gave to various factors. CMS Ex. 9, at 2. 3. Despite expressly disclaiming any request for review of the facts underlying Findings 1 and 2, Emerald Oaks criticized the ALJ in passing for her "one-sided" discussion of them. Emerald Oaks Br. at 6, n.3. This comment lacked any specific citations to the record. We therefore do not address this general critique, and we rely here on the ALJ's discussion of the evidence on these findings as no longer disputed. Emerald Oaks went on to suggest in the same footnote that the ALJ should have accepted its evidence that it could not fairly be held responsible for the nurse's actions because she had received proper training and yet had acted so far outside her duties that she lost her license. We do not find this suggestion persuasive. It is clear from the uncontested findings that the nurse was acting within the scope of her employment responsibilities, that is to provide care for the residents of Emerald Oaks. Her employer cannot disown the consequences of the inadequacy of the care provided by the simple expedient of pointing the finger at her fault, since she was the agent of her employer empowered to make and carry out daily care decisions. In any case, as even our brief summary demonstrates, responsibility for neglect of the resident, and for the implementation of a policy to forestall such neglect, does not stem solely from the actions of a single nurse. The ALJ expressly rejected this argument in discussing the findings that Emerald Oaks chose not to contest. ALJ Decision at 10. 4. Presumably, Emerald Oaks is of the opinion that a per diem CMP would have resulted in a lower amount. It is not clear that this necessarily follows, since the statute and regulations allow a CMP of up to $10,000 per day in cases of immediate jeopardy. 42 C.F.R. � 488.408. The major distinction between per diem and per instance CMPs is that, in the case of the first, the CMP accrues until the facility demonstrates that it has achieved substantial compliance (often requiring a revisit survey), whereas, in the case of the second, the facility knows the total amount of the CMP immediately upon notice of its imposition. See 64 Fed. Reg. at 13,355-58. Also, a per diem CMP for an immediate jeopardy finding could potentially exceed $10,000 if the jeopardy persisted for more than one day, whereas a per instance CMP is capped at $10,000. 5. CarePlex involved a CMP in the lower range, and the Board in that case noted that the ALJ was bound to accept CMS's assessment of the level of non-compliance. DAB No. 1683, at 16. The present case involves a CMP in the upper range. The regulations provide that, where CMS's assessment that the level of non-compliance constitutes immediate jeopardy triggers the application of the upper range of CMPs, the facility may challenge the immediate jeopardy assessment but must show that the assessment is clearly erroneous to prevail against it. 42 C.F.R. � 498.60(c)(2). 6. In addition to CarePlex, several other Board decisions have expressly rejected the concept of an ALJ review of CMS's internal process in setting a CMP amount. In Capitol Hill Community Rehabilitation and Speciality Care Center, DAB No. 1629 (1997), the Board held that ALJ review of a CMP under 42 C.F.R. � 488.438 (e) and (f) does not extend to "the particular process which HCFA utilized to establish the amount of the CMP, including what process HCFA utilized to determine the financial condition of the provider." DAB No. 1629, at 5. Similarly, the Board found that an ALJ's critique of the process used by CMS went beyond the bounds of the ALJ's authority under the regulations and held that "[w]e agree with HCFA that the ALJ should not review the process used to reach a recommendation of the CMP amount, but should focus instead on whether that amount is unreasonable." South Valley Health Care Center, DAB No. 1691, at 18 (1999). 7. In CarePlex, the Board also held that an ALJ may not independently undertake to consider factors beyond the ones specified in 42 C.F.R. � 488.438(f), despite the "catchall" clause in 42 C.F.R. � 488.404(c) allowing CMS to consider "other factors" beyond those explicitly identified. DAB No. 1683, at 10-15. This conclusion was also founded on the clear intent of the regulations to vest the discretion under section 488.404(c), which addresses the choice of a remedy, only with CMS, and to limit review of the scope of deficiencies to determining whether an immediate jeopardy finding was clearly erroneous. 8. We conclude below that the ALJ relied on the correct standard in her discussion of the record before her. We reserve for succeeding sections the question of whether each of the challenged findings is actually supported by substantial evidence in the record as a whole. 9. Although Emerald Oaks claimed that its records showed that it was not aware of any risk of falls for this resident until after the falls, a review of the very records to which Emerald Oaks cited contradicts that assertion. The resident's plan of care records an assessed risk for falls as of October 10, 2000, due to confusion, night wandering, weakness, stroke history, and medications. Emerald Oaks Ex. 9, at 1. 10. This example belies Emerald Oaks's general allegation that the deficiency findings arose from a strict liability approach extrapolating fault directly from any bad outcome. 11. The record does not even support Emerald Oaks's claim that the resident "was checked at least every hour - and sometimes more frequently as evidenced by the nursing notes." Emerald Oaks Br. at 22. The nursing notes show checks recorded at 9:30 PM (on arrival at his room), 12 AM, 12:30 AM, 1:30 AM, 3:30 AM, and 5:30 AM. Emerald Oaks Ex. 19, at 5. The succeeding entries between 8 AM and 11 AM do not report observations on the resident but rather record calls to family and doctors. The only observations recorded for the remainder of the day on October 24, 2000 were at 11 AM, 2:15 PM (an assisted transfer at that time was mentioned in a 3 PM note), and 9 PM. Id. The next note is at 6 AM on October 25, 2000. Id. 12. It is not entirely clear what Emerald Oaks intended to establish by citing numerous records of complaints and grievances by the family of Resident 12 and some of the facility's responses to them. See Emerald Oaks Br. at 37, and exhibits cited therein. While a pattern of such disputes may be consistent with unreasonable expectations or truculence on the part of the family, the same sort of documentary trail would result if the care was neglectful and the complaints well-founded. 13. In addition, the plan of action states that the DON would "inservice staff on professionalism in customer relations by 10/19/00." Emerald Oaks Ex. 72, at 1. It is reasonable to infer from this that the family's dissatisfaction was not entirely unreasonable. 14. The complaint of inadequate showering is harder to sort out because the record is confused regarding the specific dates involved. Compare ALJ Decision at 19; Emerald Oaks Br. at 38; CMS Br. at 25, n. 26; and Emerald Oaks Ex. 73. The issue need not be resolved since, as discussed in the text, more than substantial evidence supports the ALJ's finding that Emerald Oaks failed to comply with the cited regulation with regard to this resident. 15. Since the findings upheld earlier in this decision amply establish that Emerald Oaks was not in substantial compliance as of October 30, 2000, termination was mandatory. We therefore discuss the factual bases and disputes relating to these last three ALJ findings more briefly. 16. The exception is that CMS may not impose a CMP greater than $3000 per day unless a determination of immediate jeopardy has been made. In that situation alone, the provider may challenge the determination of the scope and severity level of the finding (as opposed to limiting its challenge to the underlying dispute regarding the facts or application of law to the facts to find a deficiency). Such challenge can succeed only if the provider shows that CMS's immediate jeopardy determination was clearly erroneous. 17. As it happened, the resident received the erroneous doses only on October 1, since she left before receiving medications on October 2. CMS Ex. 10, at 20-26. 18. Emerald Oaks argued that CMS did not present evidence concerning the August survey and that the ALJ originally assigned to the case (ALJ Steven Kessel) had narrowed the scope of the hearing to only the immediate jeopardy finding and the deficiency findings from the October survey, since it was agreed that Emerald Oaks would not have been terminated if it had been found in substantial compliance at the October survey. Emerald Oaks Br. at 52. The record indicates that CMS had reserved the right to present evidence from prior surveys where that formed a necessary predicate to a finding from the October survey. CMS Response to Motion to Amend (Nov. 2, 2001). The ALJ's pre-hearing order set the scope of the issues to be heard to cover "whether a basis exists to terminate" Emerald Oaks. ALJ Order and Notice of Hearing at 2 (Nov. 22, 2000). CMS placed into evidence the portion of the August survey statement of deficiencies showing the basis for that deficiency finding. Emerald Oaks did not contest the basis for the August deficiency and therefore the statement of deficiencies constitutes evidence of the nature of the prior problems with medication. 19. Emerald Oaks attacked the ALJ's use of the honorific "Dr." for Survey Supervisor Susan Acker and consistently referred to her as "Ms. Acker" in its briefs. Emerald Oaks Reply Br. at 5, n.4; see, e.g., Emerald Oaks Br. at 54, n. 35, 66. Dr. Acker is not, and did not purport to be, a medical doctor. It is undisputed that she holds a Ph.D. in health care administration, as well as being a nurse. CMS Ex. 27. As the holder of a doctorate degree, she was entitled to the honorific and we find nothing improper in the ALJ's employing it. 20. Emerald Oaks also argued that the ALJ failed to consider in evaluating this finding the testimony of Dr. Harris that the resident's terminal leukemia was the real cause of his seizures. Tr. at 225. However, Emerald Oaks did not point to any testimony that the seizures should therefore go untreated (and obviously the facility, and Dr. Harris, did attempt to treat them) so that it is irrelevant to this finding whether the seizures were a complication of the leukemia or an independent development. 21. We note here that many of the subsidiary factual findings were addressed in a fairly cursory manner in the ALJ Decision with little explanation of why some testimony or exhibits did not deserve credence or did not affect any relevant question in a material way. While a more complete discussion by the ALJ of the rationale for her apparent credibility determinations and assignment of weight to various pieces of evidence would have been helpful in following her reasoning, ultimately a complete review of all the evidence in the record clearly demonstrates that substantial evidence supports each of the challenged findings, as discussed throughout.
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