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Department of Health and Human Services DEPARTMENTAL APPEALS BOARD Appellate Division |
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DATE: January 23, 2004 |
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Centers for Medicare & Medicaid Services
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Docket No. A-03-31
Civil Remedies CR966 and CR821 Decision No. 1906 |
| DECISION | |
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FINAL DECISION ON REVIEW OF On December 23, 2002, Beechwood Sanitarium (Beechwood) filed a notice appealing the October 28, 2002 decision of Administrative Law Judge (ALJ) Steven T. Kessel on remand from this Board. Beechwood Sanitarium, DAB CR966 (2002) (ALJ Decision II). Beechwood's appeal also addressed findings in the ALJ's prior decision in this matter which Beechwood contended were not resolved by the Board's prior decision. See Beechwood Sanitarium, DAB CR821 (2001) (ALJ Decision I); Beechwood Sanitarium, DAB No. 1824 (2002) (Board Decision I). Beechwood sought to reverse sanctions imposed upon it by the Centers for Medicare & Medicaid Services (CMS). In this decision, we conclude that the ALJ's conclusions on each deficiency finding are supported by substantial evidence in the record and are free from the legal errors alleged by Beechwood. We thus sustain the ALJ's conclusions that Beechwood was not in substantial compliance with participation requirements and that CMS was authorized to impose the remedies appealed to us. Based on these conclusions, and for the reasons fully explained below, we affirm ALJ Decisions I and II, as modified below. HISTORY AND BACKGROUND OF THE CASE (1) Beechwood is a skilled nursing facility (SNF) that participated in Medicare and in the New York State Medicaid program and was subject to relevant sections of the Social Security Act (Act) and to participation requirements that are set out at 42 C.F.R. Part 483. Surveys conducted by the State Department of Health (DOH) on April 22, 1999 (April 1999 survey); May 12, 1999 (May 1999 survey); and June 14, 1999 (June 1999 survey) determined that Beechwood was not complying substantially with federal participation requirements. Based on the outcome of the April 1999 survey, DOH imposed a directed plan of correction as well as other remedies. After the May 1999 survey, CMS imposed the remedy of denial of payment for new Medicare admissions (DPNA). After the June 1999 survey, CMS terminated Petitioner's participation in Medicare. Beechwood filed a timely request for a hearing to challenge the survey findings and the imposition of remedies. The ALJ held an in-person hearing on April 3 and 17, 2001 and issued a decision. ALJ Decision I. In that decision, the ALJ concluded that Beechwood had no right to a hearing to challenge the remedy determinations that DOH had made based on the April 1999 survey and found that Beechwood was not in substantial compliance as of both the May 1999 and June 1999 surveys. Id. at 4-6, 20. Prior to the hearing, the ALJ issued rulings resolving certain legal issues, as follows:
ALJ Decision I, at 2-3. The ALJ sustained CMS's determination to impose the DPNA and to terminate Beechwood. Id. at 1. He dismissed Beechwood's request for a hearing on the April 1999 survey because he found that the directed plan of correction (DPOC) and State civil assessments imposed by DOH were State agency determinations over which he did not have jurisdiction. Id. at 4-6. He reviewed two out of ten of the deficiency findings from the May survey and three out of ten of those from the June survey. He found that Beechwood did not prove it was in substantial compliance with the requirements cited in those deficiency findings. He concluded that these findings sufficed to authorize CMS to impose the DPNA and termination and therefore he declined to make any findings "either favorable or unfavorable" to either party concerning the remaining alleged deficiencies, because he found it unnecessary to do so. Id. at 20, see also id. at 7. Beechwood appealed that decision to the Board alleging various prejudicial errors by the ALJ, which were summarized as follows:
Board Decision I, at 2. Without reaching the merits of whether Beechwood was in substantial compliance at the time of the relevant surveys, the Board reversed and remanded the case to the ALJ for further proceedings, including a new decision. First, the Board instructed the ALJ to issue the requested subpoenas, finding that Beechwood "was entitled to receive these documents so that it could make a full presentation of its case." Id. at 6. Further, the Board concluded that the ALJ had erred in dismissing Beechwood's appeal of the April 1999 survey findings that resulted in the imposition of the DPOC. The Board agreed with the ALJ that Beechwood had no federal appeal rights in relation to the State civil assessments, but concluded that Beechwood did have a right to a federal hearing on the DPOC since it was a CMS determination, issued by the State as CMS's agent. Since the ALJ had already received evidence and arguments concerning the deficiency findings made at the April and May 1999 surveys, the Board instructed him to make a determination as to whether a basis exists for the imposition of the DPOC, after receiving any additional evidence resulting from the document production ordered. The Board found no further error in the four ALJ rulings cited above and rejected a number of other contentions raised by Beechwood about the ALJ's procedure. As to the limited scope of the deficiencies from the May and June 1999 surveys that the ALJ addressed, the Board concluded that the ALJ was within his discretion in choosing to "discuss several deficiencies that he determined to be persuasively established, thereby acknowledging but minimizing the risk that the case would have to be remanded to him should one of his findings be overturned" and upheld as permissible his "exercise of judicial economy." Id. at 22. On remand, the ALJ issued a subpoena, but declined to receive any of the resulting documents into evidence. The ALJ found that Beechwood was not in substantial compliance with three of six cited requirements during the April 1999 survey and that the imposition of the DPOC was authorized. The ALJ did not make any additional findings relating to any of the issues raised by the parties in the first appeal, as the Board had invited him to do, except to clarify one point. He noted that in his first decision, he determined that particular instances of noncompliance were "substantial" by finding simply that Beechwood's actions posed the potential for causing more than minimal harm. Beechwood had argued that this indicated that CMS failed to prove the levels of harm it had asserted as to these allegations and that they should be dismissed. The ALJ explained that he "made these findings because a 'potential for causing more than minimal harm' is the regulatory test" for determining that a facility is in substantial compliance, but that in so doing he "made no findings about the actual scope and severity of the deficiencies at issue" and "neither sustained nor 'downgraded' CMS's scope and severity findings." ALJ Decision II, at 8. This appeal followed. RELEVANT LEGAL AUTHORITY Program participation and compliance provisions Under section
1866 of the Social Security Act (Act), providers of services seeking to
participate in Medicare must enter into an agreement with the Secretary.
The Act empowers the Secretary to refuse to enter into an agreement or
to refuse to renew or terminate such an agreement upon notice after the
Secretary -
Section 1866(b)(2) of the Act (referencing corresponding sections of the Act as codified in 42 U.S. Code). The regulations specify, inter alia, that CMS may terminate a provider agreement when the provider is not complying with Title XVIII of the Act, with applicable regulations, or with terms of the provider agreement itself, or no longer meets the relevant conditions for participation. 42 C.F.R. § 489.53(a)(1) and (3). The Act and the regulations also provide for the imposition of alternative remedies in addition to or instead of a termination. Sections 1819(h)(2) and 1919(h)(3); 42 C.F.R. § 488.408. Those remedies include DPOCs and DPNAs. Id. The applicable requirements for participation appear at 42 C.F.R. Part 483. The requirements which remain at issue in the deficiency findings which Beechwood challenged on appeal are identified below. The procedures for survey and certification of long-term care facilities are set out at 42 C.F.R. Part 488, subparts A and E, and in the State Operations Manual (SOM) issued by CMS. A state survey agency's failure to follow prescribed survey procedures, however, "does not relieve a [facility] of its obligations to meet all requirements for program participation or invalidate adequately documented deficiencies." 42 C.F.R. § 488.318(b); see Forest Glen Skilled Nursing & Rehabilitation Center, DAB No. 1887 (2003); Golden State Manor and Rehabilitation Center, DAB No. 1597 (1996). The seriousness of deficiencies is assessed on a scale that considers scope (how isolated or widespread the deficiency is) and severity (how great the harm or potential for harm posed by the deficiency). 42 C.F.R. § 488.404. The deficiencies are reported on a standard form which identifies specific deficiency findings and assigns "F Tag" numbers to each deficiency correlating with particular regulatory requirements. In order to be found in "substantial compliance," a provider must have no deficiencies that pose a risk to resident health or safety greater than "the potential for causing minimal harm." 42 C.F.R. § 488.301. At the other extreme, the most serious deficiencies are those determined to constitute immediate jeopardy. "Immediate jeopardy" is defined in the regulations as a situation in which a provider's noncompliance "has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident." Id. Deficiencies between these extremes are ranked by a letter from B to L on a grid system, based on the severity of the findings and the scope of their impact on residents. Based on the determination as to scope and severity of deficiencies and other relevant factors, CMS, with recommendations from the State DOH, may select among available remedies. 42 C.F.R. §§ 488.404, 488.406 and 488.408. The choice of remedy and the factors considered in selecting the remedy are not subject to appeal, but the facility may appeal the noncompliance findings leading to the imposition of a remedy. 42 C.F.R. § 488.402(g). Procedural provisions The regulations provide appeal rights and procedures for providers dissatisfied with certain initial determinations by CMS. 42 C.F.R. Part 498, implementing Section 1866(h) of the Act. Among the appealable initial determinations are "the termination of a provider agreement in accordance with § 489.53," which permits termination, inter alia, of a long-term care facility that no longer meets the participation requirements, and, in the case of long-term care facilities, "a finding of noncompliance that results in the imposition of a remedy specified in § 488.406," which includes the remedies involved here. See also 42 C.F.R. § 498.5 ("Any provider . . . dissatisfied with an initial determination to terminate its provider agreement is entitled to a hearing before an ALJ.") A line of
Board cases has articulated the distribution of the burden of proof in
appeals of enforcement actions, beginning with a case involving termination
of a rehabilitation agency, which concluded as follows:
Hillman Rehabilitation Center, DAB No. 1611, at 84 (1997), aff'd sub nom., Hillman Rehabilitation Center v. HHS, No. 98-3789(GEV) (D.N.J., slip op. May 13, 1999). In later cases, the Board has held that the same rationale, and hence the same burden of proof, applied in cases alleging lack of substantial compliance with long-term care requirements. Cross Creek Health Care Center, DAB No. 1665 (1998). Regulatory requirements at issue: The specific
requirements with which the ALJ found that Beechwood was not in substantial
compliance at one or more surveys arose from the following regulations:
STANDARD
OF REVIEW
The standard
for our review of an ALJ decision on a disputed issue of law is whether
the ALJ decision is erroneous. Our standard of review on a disputed issue
of fact is whether the ALJ decision as to that fact is supported by substantial
evidence on the record as a whole. Guidelines - Appellate Review of Decisions
of Administrative Law Judges Affecting a Provider's Participation in the
Medicare and Medicaid Programs (www.hhs.gov/dab/guidelines);
South Valley Health Care Center,
DAB No. 1691 (1999), aff'd
South Valley Health Care Center
v. HCFA, 223 F.3d 1221 (10th Cir. 2000). ISSUES
AND ROADMAP TO DECISION Beechwood's
notice of appeal requested that the Board -
Beechwood Br. at 3 (footnote omitted). Beechwood set out what it considered to be 135 ALJ errors in its initial brief, and made a number of additional points in subsequent briefing. We note that Beechwood failed to specify exactly with which numbered Findings of Fact and Conclusions of Law (FFCLs) in the two ALJ Decisions it disagreed. (3) Extrapolating from the requests and arguments in Beechwood's briefing, we infer that Beechwood disagreed with all of the FFCLs, except Findings 5 (except to the extent two CMS exhibits were also excluded), and 8 (b),(d), and (f). We proceed to review the reasons offered by Beechwood for its contentions that the ALJ made errors. Beechwood sought reconsideration of a number of preliminary matters which were already discussed in Board Decision I. In addition, Beechwood identified a number of other general matters as "key issues." (4) Many of the disputes about specific factual allegations also turned largely on a few overarching issues of legal interpretation. For efficiency, we group these general legal questions together in the first part of this analysis. The contentions addressed here relate to -
Finally, we address Beechwood's contentions that the ALJ made a prejudicial error of procedure by declining to resolve all of the deficiency allegations, including those from the April 1999 survey. The second part of this analysis considers individual factual findings challenged by Beechwood. (5) We discuss the ALJ's findings relating to the May 1999 and June 1999 surveys first because they are addressed in ALJ Decision I. We then turn to the April 1999 survey findings addressed in ALJ Decision II. We have grouped our discussion under F-Tag numbers, each of which represents a citation for failure to meet a specific regulatory requirement. Within each F-Tag section, we discuss allegations relating to specific residents, who are identified by numbers assigned to them during each survey rather than by name, in order to protect their privacy. We have not organized our discussion around the numbered "errors" cited by Beechwood in its briefing, but have considered every assignment of error. We rejected as without merit every claim of error, even if not explicitly addressed here. |
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| ANALYSIS | |
1. All issues arising from the parties' dispute over document production either lack merit or have been resolved by the Board's order and this decision.
In its prior decision, the Board concluded that Beechwood was entitled to have the ALJ issue a subpoena to CMS based on Beechwood's repeated requests to the ALJ. Board Decision I, at 3-6. The Board found that CMS had failed to produce certain documents despite a Freedom of Information Act (FOIA) request, repeated promises by CMS to produce voluntarily, and an ALJ order to produce. The Board instructed the ALJ to -
Id. at 21. On remand, the ALJ issued a subpoena. The ALJ declined, however, to receive into evidence any of the subpoenaed documents offered by Beechwood on the grounds that they contained at most notes by CMS employees who reviewed State survey reports after-the-fact and which therefore were not relevant to a de novo review of the substance of the allegations in the report. In the present appeal, Beechwood asserted that the ALJ framed the subpoena too narrowly and that CMS then gave the subpoena language an even more constricted reading to justify producing very few documents. Basically, Beechwood's position was that either CMS was improperly withholding documents to which Beechwood should have access or CMS had so little basis for its endorsement of the State recommendations that CMS's actions should be treated as a nullity. We addressed the adequacy of the subpoena and CMS's production in an order dated May 19, 2003. That order is attached as an appendix to this decision. Briefly, we found that, although the subpoena language was taken from Beechwood's February 16, 2001 request referenced in the Board's instructions, the ALJ omitted additional language in that request which, in the context of prior filings in the case, called for broader production. In addition, we found no assurance from the briefing and declaration provided by CMS that all the documents contemplated by the Board's remand had actually been produced. Consequently, to avoid any appearance that any documents may have been withheld which would support Beechwood's position in this case, we ordered CMS to provide to us a list of all documents in CMS files relating to the three relevant surveys and, as to each, either provide it, note that it has already been provided, or give a basis for withholding it and provide it for in camera inspection. We noted that this process would eliminate the risk that documents which should have been released would later be produced pursuant to FOIA and potentially undercut the finality of this appeal. On June 9, 2003, CMS provided the required list, along with a statement clarifying its intentions in document production. Beechwood was then granted permission to file a supplemental brief which was submitted July 14, 2003. In that brief, Beechwood further developed its alternative position that the CMS documentation was now shown to be so inadequate as to require all allegations against Beechwood to be vacated. CMS responded to Beechwood's arguments on July 23, 2003. We address this substantive line of argument separately below. At this point, however, we note that any problem relating to the scope of the ALJ subpoena or CMS's response to it has now been cured by the issuance of the Board's production order and the definitive assurance by CMS that it has now provided all relevant evidence either by virtue of the State's production of documents prior to the State ALJ hearing, as part of CMS's exhibits in the hearing below, or otherwise during the proceedings below. Since Beechwood no longer disputed that contention, but rather rested on the position that the documents so made available demonstrated the absence of considered action by CMS, we conclude that no further issue remains in regard to the adequacy of document production.
Although we find that no live dispute now exists about document production in discovery, disputes persist about the status of some documents. The ALJ excluded from the record for decision all the documents resulting from his subpoena. Beechwood appealed that ruling to us. The ALJ also excluded several exhibits proffered by Beechwood and CMS on remand on the basis that they went only to issues which had already become administratively final. In addition, Beechwood attached a new exhibit numbered 32 to its supplemental brief. We next explain the nature of each exhibit and then set out our ruling on the admissibility of these items into the record.
These exhibits were produced by CMS in response to the subpoena and then offered by Beechwood, which described them as consisting of: "a handwritten chronology of events and other notes prepared by CMS surveyor Michael Daniel relating to the April SOD allegations . . . ; copies of the April SOD with handwritten review notes by CMS surveyors Michael Daniel and Linda Tardiff . . . ; and a Declaration of Sue Kelly (Kelly Declaration), CMS Associate Regional Administrator, May 2, 2002 . . . ." Beechwood Br. at 4. The ALJ excluded these documents as irrelevant since they were offered in relation to arguments about whether CMS conducted a proper review of the State's recommendations about remedies to impose on Beechwood due to the alleged deficiencies. ALJ Decision II, at 4-5. The ALJ concluded that these arguments were irrelevant to the issues properly before him, explaining as follows:
Id. at 5. As more fully developed later in this decision, we agree with the ALJ that his proper focus was not on an appellate review of CMS's decision-making process but on the factual basis for CMS's imposition of remedies. We find no error in the ALJ's exclusion of these documents for the purposes for which Beechwood offered them below. Before us, Beechwood argued that these documents are "relevant and material, because they constitute the entire quantum of work papers generated and maintained by CMS with respect to these allegations against Beechwood." Beechwood Br. at 4. Beechwood reasoned that the scarcity of work product proved "a dearth of analysis and oversight by CMS of the State surveyors." Id. According to Beechwood, it had now established that there had been "no proper documentation or formal determination by CMS supporting the concurrences CMS blithely gave to the State . . . ." Id. Beechwood shifted its ground somewhat by arguing before us that the amount of documentation in CMS's records demonstrated that no CMS "initial determination" ever occurred. Beechwood explained in a telephone conference that it was unable to articulate this argument below because the inadequacies of the subpoena process left it uncertain whether CMS admitted that the documents produced represented its complete file on Beechwood's termination. The Board permitted Beechwood to file a supplemental brief. We consider, and reject, below the substance of Beechwood's claim that no CMS "official action" occurred. The discussion would, however, be difficult for a reviewing court to follow without access to the "quantum of work papers" being discussed. The Kelly Declaration also stands in a different position before us than before the ALJ because CMS relied on it in argument before us to justify its response to the ALJ's subpoena. Hence, any objection CMS might have had to its admission was deemed to be waived and the Kelly Declaration was discussed in our attached order. Finally, Beechwood offered a new exhibit consisting of data relating to Beechwood's history which it extracted from a CMS online database on provider compliance. CMS did not object to the exhibit, but noted for the record that the proffered pages were not the direct output of the database but had been compiled by Beechwood. Thus, CMS did not vouch for either the accuracy or the completeness of the contents. Beechwood relied on this material as confirming "the absence of CMS official action and documentation with respect to the allegations made, and remedies imposed against Beechwood." Beechwood Supp. Br. at 3, n. 2. In the interests of a comprehensible record, it is preferable now to admit these exhibits, although it was not error for the ALJ to exclude them below. The documents produced by CMS and Petitioner's Exhibit 32 are presented now for an argument which Beechwood contended it was unable to raise below because of problems with discovery which we have cured by our order. As to the Kelly declaration and Petitioner's Exhibit 32, CMS waived any objections to admission (while arguing as to probative value). The Board has authority to admit evidence on appeal "if the Board considers that the additional evidence is relevant and material to an issue before it." 42 C.F.R. § 498.86(a). In our discussion, we give only such weight as we find appropriate to these new exhibits, but, for the reasons explained above, we consider them relevant and material to issues raised at the present stage of the case.
This exhibit consisted of a newspaper announcement to the public rescinding the May 15, 1999, termination of Beechwood. The ALJ excluded it on two grounds: (1) that Beechwood could have but did not offer it into evidence at the hearing and (2) that it relates to a claim which the ALJ resolved and the Board upheld as to the adequacy of the notice provided in imposing the DPNA on Beechwood. ALJ Decision II, at 5-6. On appeal, Beechwood argued that the document was already part of the record because it was attached to Beechwood's response to CMS's original summary disposition motion and also to Beechwood's first appeal to the Board. Beechwood Br. at 6. Beechwood contended that the ALJ and Board had failed to appreciate the significance of the content of the newspaper announcement. Id. CMS responded that the ALJ properly excluded the newspaper announcement because the Board did consider it in analyzing the announcement issue in Board Decision I, and "properly disregarded it." CMS Br. at 12. Certainly, CMS, the ALJ, and the Board have been aware of and have discussed this newspaper announcement since early in this case. Since this document is the subject of evaluation and discussion in both ALJ and Board decisions, and is already a part of the administrative record in multiple locations, the decision not to admit it into evidence, while certainly within the ALJ's discretion, is of largely semantic significance. We discuss below Beechwood's request for reconsideration of the legal notice question and again discuss the newspaper announcement in that regard. For the limited purpose of giving context to that discussion, we also admit this document into the record for decision. We note that doing so after the hearing does not present the difficulties that might otherwise exist if the evidentiary record on which the ALJ made his factual findings were altered after the fact. In this instance, since CMS did not contest the facts about the newspaper announcement, the document goes solely to a legal question of notice, rather than to any factual allegations at issue in the hearing.
These documents consist of excerpts of the State ALJ's decision on State civil money assessments. The situation with them is much like that with Exhibit M0011. The ALJ is correct that the issue to which they are directed was already resolved in Board Decision I. Yet, Beechwood argued in this appeal that directing attention to specific language in these excerpts would serve to correct "mistaken assumptions" on which the conclusion there rested. We discuss this argument below and again conclude that admitting the documents into the record for decision for limited purposes, even where they do not alter our conclusions, will provide a better context to understand the discussion. Again, these documents have no relation to the hearing record on which the ALJ decided the factual allegations.
The issues relating to this exhibit are somewhat different from those above, because it was proffered by CMS not Beechwood. CMS sought before the ALJ to introduce additional exhibits in regard to the characterization of the State civil money assessments. The ALJ excluded these proffered exhibits on the same basis as with some of Beechwood's exhibits, i.e., that the issue had been conclusively resolved and did not require clarification, and "also because I have declined to receive the other documents that CMS produced in response to the subpoena that I issued." ALJ Decision II, at 6. CMS chose not to appeal ALJ Decision II to the Board. In its response brief to Beechwood's appeal, CMS tried nevertheless to challenge the exclusion of HCFA Exhibit 48 as an error by the ALJ which it asked the Board to reverse. We find that CMS did not have standing to seek reversal of a portion of an ALJ decision that it did not appeal. In the alternative, CMS asked the Board to admit the document, consisting of the State ALJ's Decision on a Motion to Dismiss, pursuant to the Board's authority under 42 C.F.R. § 498.86. We do so here for the same reasons and for the same limited purposes as with the related exhibits proffered by Beechwood. 2. An erroneous newspaper announcement does not defeat direct notice to the facility of continuing noncompliance. Beechwood continued to press concerns relating to the fourth of the ALJ Rulings cited above in regard to whether the process by which the DPNA was imposed on Beechwood was fatally flawed. Beechwood argued that it provided over $120,000 in uncompensated care after the DPNA was imposed on May 21, 1999. Beechwood Br. at 7, n.5. It did so, according to Beechwood's arguments in the present appeal, because "it seemed clear that the immediate DPNA was on its face invalid without a 15 day advance notice" and no time was available to make alternative placement arrangements. Id. One of the owners testified at the hearing that he "didn't think the payment ban was correct," and that therefore the facility "continued to take those patients . . . and notified them accordingly, just as usual, you will be getting Medicare coverage." Tr. at 286-87 (April 17, 2001). He further testified that this was the facility's practice from May 21, 1999 through the date in June by which the owner calculated that the facility had had legally sufficient notice. Id. Since the facility did not notify the patients admitted during that time that they would have to make other payment arrangements, he testified, the facility bore the losses. Id. at 287, 297-98. Thus, Beechwood asserted, the question of notice was not academic despite the subsequent termination. Further, Beechwood contended that the Board failed to appreciate the significance of the specific wording of the newspaper announcement which led Beechwood to believe that notice was inadequate. The regulations provide certain notification requirements for the imposition of remedies. 42 C.F.R. § 488.402(f). The required notice must include the nature of the noncompliance, the remedy to be imposed, the effective date, and appeal rights for the determination leading to the remedy. 42 C.F.R. § 488.402(f)(1) -(2). In the case of immediate jeopardy findings, notice of remedies, other than state monitoring and CMPs (7), "must be given at least 2 calendar days before the effective date of the enforcement action." 42 C.F.R. § 488.402(f)(3). Where no immediate jeopardy is found, notice of remedies other than CMPs or state monitoring "must be given at least 15 calendar days before the effective date of the enforcement action." 42 C.F.R. § 488.402(f)(4). The notice periods begin when the facility receives the notice. 42 C.F.R. § 488.402(f)(5). In addition to notice to the facility, the Act requires that information be made available to the public about the results of surveys, including statements of deficiencies, within 14 days after it is made available to the facility. Sections 1819(g)(5)(A) and 1919(g)(5)(A). Such information enables the public, including those who may be considering or using the facility, to make better informed decisions. We next summarize the relevant sequence of communications in order to clarify the state of notice to Beechwood as of May 21, 1999, when it incurred the costs of which it now complains. On April 23, 1999, the State survey agency formally notified Beechwood that immediate jeopardy was found during the April 22, 1999 survey. HCFA Ex. 1. On April 27, 1999, the State survey agency forwarded the full SOD, informed Beechwood that termination was recommended to CMS for May 15, 1999, and put in place the DPOC and State monitoring. HCFA Ex. 2. On May 7, 1999, CMS notified Beechwood that the April 22, 1999 survey had resulted in findings of immediate jeopardy which must be abated to avoid termination on May 15, 1999 and, further, stated that a reduction in the seriousness of the noncompliance might lead to a change in remedy. Beechwood Br., Att. 6. The notice also stated that no payment for new admissions would be made after May 15, 1999. On May 11, CMS sent an amended notice to Beechwood with the same content but a correction to the mailing address. HCFA Ex. 4. On May 13, 1999, a legal notice to the public in the newspaper announced the scheduled termination and the DPNA for admissions after May 15, 1999. On May 12, 1999, the State survey agency conducted a revisit to determine if immediate jeopardy had been abated and substantial compliance achieved. Beechwood did not dispute that an exit conference took place. Generally, during such an exit conference, the surveyors would indicate their conclusion that the facility had not achieved substantial compliance. On May 15, 1999, a newspaper announcement stated that the termination was rescinded and Beechwood was now in compliance. On May 21, 1999, the State survey agency informed Beechwood that there was no longer any immediate jeopardy but that the facility was still not in substantial compliance, forwarded the SOD, and stated that a DPNA was recommended. HCFA Ex. 3. CMS sent out its own notice dated May 21, 1999. HCFA Ex. 5. CMS's May 21, 1999 notice stated that the termination was rescinded but that, "due to the seriousness of the deficiencies still remaining," termination would take place on June 17, 1999 unless the deficiencies were corrected, and that a DPNA would be imposed as of the receipt of the CMS notice letter. The Board's first decision resolved this issue as follows
Board Decision I, at 17. In the present appeal, Beechwood argued that the Board had failed to appreciate the significance of the fact that CMS stated, in the public announcement of rescission of termination, that CMS "has determined that the Beechwood Sanitarium is now in compliance" with applicable requirements. Id. at Att. 8. Beechwood argued that this legal announcement in the newspaper did not merely announce the abatement of immediate jeopardy and retract the termination. Because it went further, announcing that Beechwood was in substantial compliance, Beechwood argued that the announcement led Beechwood and the public to expect payment for subsequent admissions. CMS acknowledged that the statement in the newspaper notice was wrong, since the survey revisit did not in fact find substantial compliance, and described it as likely the "product of human error." CMS Br. at 13. Nevertheless, CMS argued that a mistaken newspaper announcement could not override the notices directly sent to Beechwood informing the facility of the repeated findings that it was not in substantial compliance. There is no question that the statement in the newspaper announcement about Beechwood "now" being in compliance was a mistake. Each of the relevant surveys resulted in determinations that Beechwood was not in substantial compliance. The significant change from the April 22, 1999 survey to the revisit on May 12, 1999, was the finding that immediate jeopardy had been abated. We cannot determine why the newspaper announcement erroneously reported a different result from the May 12, 1999 revisit. Human error is certainly a reasonable possibility, especially since a one-letter typographical error (from "not" to "now") would suffice to have reversed the meaning. The question before us now, however, is limited to what legal effect the error had on the validity of the DPNA imposed as of May 21, 1999. We do not address, nor have we jurisdiction over, any potential complaint by a resident or a member of the public that the error confused or harmed them. That is, we cannot consider what rights, if any, individuals may have based on the requirements of notice to the public. We deal here only with the regulatory provisions for notice to a provider about the imposition of remedies. The newspaper announcements were aimed directly at notifying interested members of the public about the status of Beechwood. Beechwood itself was notified about determinations of its compliance status through other channels. In addition to the written notices listed above, it was not contested that exit conferences took place during the surveys which surely would have included discussion of the surveyors' concerns. Even if Beechwood had been aware of the erroneous announcement at that time (a question on which it offered no evidence), Beechwood certainly had enough direct information to alert it that the announcement was inconsistent with all the other indications it had received that the State (and CMS) continued to consider it out of substantial compliance. We conclude Beechwood was not entitled to rely on the newspaper announcement alone as interrupting the notice period. Furthermore, the detrimental reliance that Beechwood asserted consisted of costs incurred in providing uncompensated services to residents admitted after May 21, 1999. But it is undisputed that, as of May 21, 1999, Beechwood had actual notice that a DPNA was in effect. Beechwood's assertion that it continued to admit these residents because it was sure that it could later prove the notice period was inadequate as a result of the newspaper announcement is simply unreasonable. We conclude that, at the least, Beechwood could not simply act on an assumption that it would later prevail on a claim of inadequate notice without making any effort to contact either the State agency or CMS for clarification. Beechwood made two additional suggestions about why the May 7, 1999 letter did not suffice as notice. First, Beechwood stated that May 7 is only 14 days in advance of May 21, so that the notice period was one day short. Hence, Beechwood asserted that the notice failed since the Board is not "empowered to rewrite the regulations to allow a 14 day notice." Second, Beechwood argued that the May 11, 1999 amended notice superseded the first letter and thus reduced the notice period to 10 days. The notice periods in the regulations begin on the date the facility receives the notice. 42 C.F.R. § 488.402(f)(5). Beechwood did not present argument about the dates on which it received each of the letters. If the May 7th and May 21st notices were received on the those dates, the notice period would include both dates, totaling 15 days. Even assuming that the notice period should have excluded May 7th from the counting period so as to arrive at 14 days, we would not conclude that the DPNA was void. Rather, at most, an adjustment for residents admitted on the day of May 21st would remedy any error. Since Beechwood did not specifically assert that it admitted any new residents on May 21st, we decline to order any such adjustment. As for the amended notice, nothing in the letter suggests that Beechwood was free to disregard the previous notice. The only change is a correction of the mailing address on the face of the letter. (8) We thus find that Beechwood has not presented anything that would cause us to alter our conclusion in Board Decision I that the DPNA was valid. 3. Beechwood was not entitled to a federal hearing on the civil assessments imposed by the State. In addition to the remedies imposed by CMS based on the recommendation of the State Medicaid agency, the State DOH itself revoked Beechwood's license to operate in the State and took several additional actions against Beechwood. Among these were a DPOC based on the April survey and fines based on the deficiencies found during the June survey. Beechwood initially challenged both of these remedies, but the ALJ ruled that he had no authority to decide "challenges of actions . . . taken by the New York State survey agency." ALJ Decision I, at 3, 6. On appeal, the Board distinguished between the DPOC and the fines and concluded that Beechwood was entitled to a hearing before the ALJ on the former but not the latter. Board Decision I, at 6-12. The distinction resulted in large part from Section 7314 of CMS's SOM, which provides that a category 1 remedy (which includes DPOCs) imposed by a state agency is automatically considered to be approved by CMS unless disapproved within two days of notice to the CMS regional office. See Board Decision I, at 9-10, setting out the full text of this provision and explaining its applicability to the DPOC here. The Board explained that federal appeal proceedings under 42 C.F.R. §§ 498.3 are limited to "reviewing initial determinations that CMS makes with regard to" certain listed matters, including "a finding of noncompliance that results in the imposition of a remedy specified in §§ 488.406 . . . ." 42 C.F.R. §§ 498.3(b)(13). Among the remedies specified are DPOCs and "[a]lternative or additional State remedies approved by" CMS. 42 C.F.R. §§ 488.406(a)(7) and (9). The Board also noted that the notice imposing the DPOC expressly informed Beechwood that appeal rights had attached under Part 498. Board Decision I, at 6-7, and exhibits cited therein. By contrast, the Board found that Beechwood did not have a right to a federal hearing relating to the state fines. Board Decision I, at 11-12. Beechwood did not contest that the State, and not CMS, imposed the fines, however characterized. Unlike DPOCs, monetary penalties, such as fines or CMPs, are not category 1 remedies for which CMS approval of state action is implied absent explicit disapproval. Beechwood did not identify any affirmative approval of the fines by CMS (or even notice to CMS of their imposition). Consistent with these observations, Beechwood could not identify any notice which it received that granted Part 498 appeal rights for these State-imposed fines. The Board noted that Beechwood did take advantage of State appeal rights and had a full hearing before a State ALJ (some of the transcript of which was admitted into the record before the ALJ). Id. Beechwood continued in this appeal to press its position, as stated before at both the ALJ and appellate levels, that the fines imposed on it by the State DOH constituted federal CMPs. Based on that premise, Beechwood further argued that the State hearing was inadequate to provide due process because the State ALJ relied on federal deficiency findings. Consequently, Beechwood reasoned, the ALJ here was obligated by the imposition of CMPs to provide a hearing under 42 C.F.R. §§ 498.3(b) broad enough to evaluate all the factual allegations underlying, as well as the scope and severity of, each deficiency, in order to determine if the CMPs were authorized and reasonable in amount. Therefore, Beechwood concluded, it was error for the ALJ to conduct his more limited review of only those deficiencies necessary to support the non-CMP remedies and not to evaluate the CMPs. The arguments and evidence proffered by Beechwood do not alter our conclusion that the state fines, however characterized, were not federal CMPs, for the reasons we now explain. The participation of the State in the Medicare and Medicaid survey enforcement program includes a role for the State in recommending, and in some cases imposing, remedies under federal law. Sections 1819(h) and 1919(h) of the Act. The scope of a state agency's authority to act itself on behalf of CMS is limited to imposing Category I federal remedies (such as DPOC). See Board Decision I, at 11, citing SOM § 1703. These remedies are specifically "in addition to any others available under State or Federal law . . . ." Id.; 42 C.F.R. §§ 488.400. Thus, the State's involvement in the federal survey process does not preclude the State from taking action under its own State law.Beechwood pointed to the fact that State civil money penalties are described in the State's approved Medicaid plan as evidence that the fines here were approved by CMS. Beechwood Br. at 10. Beechwood overlooked the fact that the State plan specifically identifies such State civil money penalties as "additional remedies" which the State may assess to fine facilities up to $2,000 per violation under Section 12 of the State Public Health Law in situations calling for Category 2 enforcement remedies (noting that the State's nursing home requirements mirror or exceed those in 42 C.F.R. Part 483). The State plan did not purport to substitute its fines for federal CMPs (as it did, for example, in the case of the federal temporary management remedy, where a stricter State process for appointed receivers was approved as an alternative remedy under the State plan). Compare Exs. M5389 with M5391 and M5396 in Beechwood Brief, Att. 6, internal Ex. G. That CMS approved the State plan, including this description of potential fines under State law, does not suffice to turn every State-imposed fine into a federally-approved remedy. As we noted, these fines are imposed in Category II situations, not as Category I remedies where a State action is treated as approved by CMS if not disapproved. We also noted in our earlier decision that Beechwood had failed to show that the State fines constituted an initial determination as defined in 42 C.F.R. §§ 498.3(b) (a prerequisite for a federal hearing right). Board Decision I, at 11-12. Beechwood cited again in this appeal to a number of regulatory provisions in 42 C.F.R. Parts 488 and 498 that refer to notice and hearing rights to dispute CMPs, and reasoned that these provisions must apply because the fines are described in the State plan and in various other documents as State "civil money penalties." Beechwood Br. at 10. The State plan, as well as various other documents in the record, uses multiple terms in referring to these remedies, including "CMPs," "fines" and "penalty assessments." We do not find any jurisdictional significance to the name assigned to these fines. The relevant question is whether they are purely State remedies or constitute CMS initial determinations appealable under the federal regulations. What the State calls a remedy does not determine whether it was imposed under the Act, as opposed to under other applicable State laws, nor does the characterization of it alone make its imposition an "initial determination" by CMS unless made so by federal law. See Board Decision I, at 11-12. Furthermore, any procedural or substantive concerns which Beechwood had with the State licensing hearing resulting in the revocation of its operating certificate and the civil penalty assessments are matters governed by State law over which we have no jurisdiction. CMS asserted that Beechwood abandoned its appeal of State actions; Beechwood denied that the appeal was abandoned. In any case, any remedy for the State action lies with the State. 4. The termination here was not "early," and no special threshold applies to the validity of non-mandatory terminations. Beechwood repeatedly characterized its termination as "early," implying that somehow an especially high threshold should be required when the facility was not out of compliance for more than six months. See, e.g., Beechwood Supp. Br. at 4-6. In its earlier appeal, Beechwood had contended that it should have been given six months in which to resolve the problems at its facility. The Board already rejected this theory, noting that -
Board Decision I, at 15, quoting Beverly Health and Rehabilitation - Spring Hill, DAB No. 1696, at 30-31 (1999), aff'd sub nom. Beverly Health and Rehabilitation Services, Inc., v. Thompson, 2002 WL 31109618 (D.D.C. 2002). Thus, if immediate jeopardy had not been abated promptly or if substantial compliance still had not been achieved after six months from the first survey, CMS would have had no choice but to terminate Beechwood. In the intermediate case presented here, where immediate jeopardy has been abated but the facility remains out of substantial compliance which has not yet persisted for six months, CMS has discretion to proceed with termination and/or to select an alternative remedy. Thus, the Board has held that "[o]nce 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." Emerald Oaks, DAB No. 1800, at 39 (2001); Carmel Convalescent Hospital, DAB No. 1584, at 25 (1996)(a single deficiency can be sufficient to justify termination). The option of imposing alternative remedies was created by Congress in order to allow CMS to apply pressure to motivate facilities to solve problems quickly, instead of having only the single "weapon" of termination to which CMS might be reluctant to resort in every instance of substantial noncompliance. See H.R. Rep. No. 391, 100th Cong., 1st Sess. 942 (1987); 59 Fed. Reg. 56,116-17, 56,177-78; see also Regency Gardens Nursing Center, DAB No. 1858 (2002); CarePlex of Silver Spring, DAB No. 1683 (1999), Golden State Manor and Rehabilitation Center, DAB No. 1597 (1996). Beechwood basically attempted to reshape its argument to suggest that, even if it was not entitled to more time in which demonstrate compliance, it nevertheless should be able to demand of CMS some greater showing of seriousness or urgency to justify the "early" imposition of termination. This recasting is equally meritless. A termination is not "early" merely because it is not yet mandatory. As a point of fact, CMS did not terminate Beechwood at the earlier point at which it could have done so. CMS postponed the initially proposed termination date once immediate jeopardy was found to have been abated, thus giving Beechwood opportunities to correct its deficiencies, and resurveyed to see if Beechwood could show that it had achieved substantial compliance. The termination thus was certainly not "early" in the sense that it was precipitous or premature, as Beechwood implied. 5. CMS' "lack" of documentation of its review of State findings or its decision-making process in imposing remedies is irrelevant. At the heart of this disagreement is Beechwood's concept of the sort of documentation that CMS "ought" to have had to concur with the State findings. Beechwood reasoned that, if the documentation maintained by CMS to support its determinations (based on what CMS ultimately produced as a result of the discovery orders discussed elsewhere) did not comport with that concept, then the determinations were unsupported. Beechwood continues to misunderstand the entire function of the hearing process provided here, despite repeated explanations by the Board and the ALJ. We therefore summarize here the basic nature of the appeal process as a foundation for Beechwood to understand the resolution of this legal argument. This appeal process does not review how or why CMS decided to impose remedies. The appeal is not restricted to the facts or evidence that were available to CMS when it made its decision. An appeal instead gives the facility a completely fresh look by a neutral decision-maker at the legal and factual basis for the deficiency findings underlying the actions CMS has taken against the facility and a clean slate to prove that the facility was in substantial compliance with the requirements it is alleged to have violated. That is the essence of a "de novo" review, that the relevant issues are decided anew. In a de novo review, for example, what CMS knew when it imposed a remedy or how it made its decision is simply immaterial to what the ALJ may conclude about whether the evidence developed during the appeal about the deficiency findings suffices to authorize imposition of the proposed remedy. The Board has carefully articulated the burden that each party must carry to prevail in the de novo review in these cases. CMS must explain the basis of the proposed actions and show evidence on disputed facts that, together with the undisputed facts, is sufficient to show that the facility is not complying substantially with one or more participation requirements. That is the essence of its "prima facie" case. CMS thus need not explain, for example, the thought processes by which it decided to proceed as it did, the nature of its review of or interaction with State agency staff, or what weight it gave to particular findings in selecting the remedy to impose. These matters are expressly placed within the discretion of CMS. Instead of revisiting what CMS did to reach its decisions, the hearing is to focus on finding the facts about conditions and events in the facility. The ALJ is then to determine whether the facts as found by the ALJ legally support the proposed remedies. In this context, we turn to Beechwood's assertion that all allegations of noncompliance made by CMS should be dismissed and all remedies vacated because "CMS has no documentation showing that it ever actually made any 'initial determination' concerning a lack of compliance by Beechwood, or the remedies to be applied . . . [and] no justifiable and documented official CMS action ever took place." Beechwood Supp. Br. at 2; see also Beechwood Br. at 4-5. Beechwood argued that the remedies were "based solely on unreviewed recommendations" which "never acquired the imprimatur of CMS." Beechwood Supp. Br. at 3, 4 (footnote omitted). This position disregards the issuance of formal initial determinations by CMS in the form of notice letters to Beechwood imposing each of the remedies at issue, or extending the effective dates. The May 11, 1999 letter from CMS explained on its face that the remedies imposed therein were subject to the appeals process applicable to CMS initial determinations under 42 C.F.R. Part 498. HCFA Ex. 4. The May 21, 1999 letter rescheduling the termination referred back to the May 11, 1999 notice; and the June 29, 1999 letter again referred to Beechwood's appeal rights and noted that they had been exercised by Beechwood's counsel on May 22, 1999. HCFA Ex. 5. We cannot agree with Beechwood, therefore, that the May 21, 1999 and June 29, 1999 notices were "grossly deficient" and lacked notice of appeal rights. Beechwood Supp. Br. at 5, nn.4,5. Apparently, Beechwood felt that the notice letters should have contained independent findings rather than relying on findings in the SODs from the various surveys in order to constitute "actual" CMS initial determinations. There is simply no foundation for Beechwood to impose its own conceptions of what initial determinations should look like and disregard entirely the text of the CMS notices that it received. Appealable initial CMS determinations are listed at 42 C.F.R. § 498.3(b) and include findings of noncompliance at a skilled nursing facility that result in imposition of remedies such as those at issue here. The regulation does not restrict this definition to only such determinations issued by CMS after a specific documentation process. While Beechwood may argue that the initial determinations here were wrong (and indeed has done so in challenging specific noncompliance findings), Beechwood cannot prevail by simply denying the existence of "official CMS action." Indeed, were Beechwood to prevail on such a claim, it would defeat the existence of jurisdiction for an appeal under Part 498, since such jurisdiction arises only over an official CMS action in the form of a listed initial determination. Because the hearing is to focus on fact-finding not second-guessing, Beechwood is equally wrong in its claims that "the entire evidentiary presentation by CMS at the hearing was nothing more than an after-the-fact attempt by CMS counsel to supply a rationale sufficient to sustain the termination, even though CMS had imposed the remedy without actually having any decision-making process." Beechwood Supp. Br. at 6. The question before the ALJ was what the admitted facts and the evidence presented by CMS and Beechwood as to challenged facts proved about the noncompliance findings leading to the remedies proposed. The existence of any prior "decision-making process" by CMS is as irrelevant as its content or quality. The relevant decision-maker on all the contested issues once an appeal was taken was the adjudicator. The ALJ in this case understood that role clearly and the Board has already sustained his analysis that "the lawfulness of processes or procedures that were used by a State survey agency to obtain evidence of a facility's noncompliance or that [CMS] used to make its determinations . . . are plainly outside the scope of the authority that has been delegated to me." Board Decision I, at 13, quoting with approval from ALJ September Ruling at 2. We conclude that the question of whether CMS engaged in any particular decision-making process at all is equally outside the scope of this appeal process. 6. The distinction pressed by Beechwood between CMS's authority to terminate and its justification to terminate is not supported. Beechwood also suggested that the ALJ's inquiry should not have stopped with determining whether CMS had sufficient legal authority to terminate Beechwood. Beechwood argued that mere authority to act does not equal justification to terminate and that the ALJ should have gone on to consider whether CMS's choice of termination was justified. Beechwood App. Br. at 13. Beechwood contended that it had placed at issue whether its termination was "in accordance with 42 C.F.R. § 498.52 and other applicable laws and regulations (498.3(b)(7); 42 USC 1395i-3)," and that CMS should therefore have had to present "a prima facie case that this remedy was justified." Beechwood Supp. Br. at 4-5. Beechwood contended that its position that termination must be not only authorized but justified was supported by language which it quoted from a prior decision of the same ALJ and from a Board decision in still another case. Beechwood Supplemental Br. at 6-7, quoting Nazareno Hospice Care, DAB CR386 (1995) ("[T]he paramount question which must be resolved in deciding whether termination is reasonable is whether a provider's failure to comply with participation requirements predicts a likelihood that the provider will not be able to deliver care in the future.") and CSM Home Health Services, DAB No. 1622 (1999) (An ALJ "must necessarily make a judgment concerning whether termination is justified."). These selective case quotations cannot support Beechwood's broad assertions that CMS must prove something more than a legal basis for termination. Nazareno was decided before the issuance of the Hillman decision by the Board and erroneously placed the burden of proving noncompliance on CMS. Furthermore, the ALJ found that CMS "failed to prove, by a preponderance of the evidence, that the Petitioner did not comply with conditions of participation." Nazareno at 2 - 3. In other words, the ALJ concluded that the termination was not authorized. Immediately after the words quoted by Beechwood, the ALJ went on to point out that "the Act and regulations make it plain that an inference may be drawn from a provider's substantial failure to comply with participation requirements that the provider is likely to remain deficient in the future." Nazareno at 16. The succeeding discussion by the ALJ deals with what failures may be considered substantial in the context of requirements then applicable to hospice facilities which were divided into high-level "conditions" and lower-level "standards." The requirements presently applicable to long-term care facilities are not divided in this manner and are subject to an express definition of what constitutes a failure to comply substantially. The ALJ here evaluated the deficiency allegations against that definition, i.e. of not meeting "a level of compliance . . . such that any identified deficiencies pose no greater risk to resident health or safety than the potential for causing minimal harm." 42 C.F.R. §§ 488.301. CSM similarly dealt with a home health agency (HHA) governed by different requirements than those applicable here. 42 C.F.R. Part 484. Those regulations establish a series of conditions of participation which must be met to allow participation by an HHA in Medicare. The compliance with the condition-level requirements is determined by evaluating performance under a number of subsidiary standards. Instead of such a standard/condition level dichotomy, however, the long-term care regulations treat all requirements as important and define "substantial compliance" for purposes of survey and enforcement involving such facilities. Nothing in those regulations suggests that a facility determined not to be in substantial compliance with participation requirements can preclude CMS from terminating its provider agreement on Beechwood's theory that some further "justification" is called for. The argument amounts to a back-door objection to CMS's discretion to select what remedy to impose. The regulations specifically preclude appeal of CMS's "choice of alternative remedies to be imposed on a provider . . ." 42 C.F.R. § 498.3(d)(11); see also 42 C.F.R. § 488.402(g)(2). The prior Board case that most directly governs this question is Beverly Health and Rehabilitation - Spring Hill, referenced above in another context, which held as follows:
DAB No. 1696, at 20-21 (footnotes omitted). The Board there further stated that --
Id. at 23. We find that this rationale also applies here, in that Beechwood is entitled to administrative review of whether CMS had the authority to impose a remedy but not to a review of whether the remedy selected, if authorized, was too harsh or otherwise inadvisable. Beechwood also contended that CMS was required to "justify the termination as a valid 'initial determination,'" because CMS's "declared policy" as set out in a Supreme Court decision is that "terminations from the Program are rare and generally reserved for the most egregious recidivist institutions." Beechwood Supplemental Br. at 4, quoting Shalala v. Illinois Council on Long Term Care, Inc., 529 U.S. 1, 22 (2000). Illinois Council dealt with what kind of issues must be channeled through the administrative appeals process before judicial review is available. The context for the statement referenced by the Court was a claim by the plaintiff that any facility with deficiencies was forced to a Hobson's choice between (1) submitting a plan of correction and avoiding any remedy while sacrificing any challenge to the alleged deficiencies or (2) being terminated in order to access the administrative appeals system. The Secretary responded that less severe penalties than termination were the norm in practice, reporting that "only 25 out of more than 13,000 nursing homes were terminated in 1995-1996." Illinois Council at 22. Indeed, Beechwood itself was not terminated until after conditions there had been found to present immediate jeopardy to the residents and even then only after it had been found to be out of substantial compliance on more than one occasion. In any case, Beechwood has pursued its administrative remedies and preserved its right to judicial review, which was the concern in Illinois Council. We see nothing in Illinois Council that can plausibly be read to create an additional hurdle for CMS to pass by having to prove that termination is not only authorized but "justified" in some sense other than lack of substantial compliance. 7. The ALJ did not err in upholding non-immediate jeopardy deficiency findings without re-evaluating the assigned scope and severity levels. Regulations provide that only in specific and limited situations may a facility attack the level of seriousness assigned to the deficiency, i.e., its alleged scope and severity. Those situations are ones in which the correctness of the assigned scope and severity levels itself affects CMS's authority to impose a proposed remedy or the reasonableness of the amount of a CMP. For example, CMS may impose a CMP greater than $3,000 only where immediate jeopardy is shown. None of the situations cited in the regulations are present here. The Board has previously explained that CMS's regulations "clearly provide for review of the factual basis for a deficiency finding on which a proposed sanction is based, but preclude review of the determination of the level of noncompliance in a non-immediate jeopardy case." (10) Koester Pavilion, DAB No. 1750, at 8. In its first appeal, Beechwood argued that the ALJ had "downgraded" certain deficiencies by not making findings of actual harm even though CMS had cited them at the "actual harm" level of severity. The Board declined to reach this argument in its first decision in order to allow the ALJ to revise or expand his findings on remand, stating -
Board Decision 1, at 23, n.8. On remand, the ALJ did not alter his findings as a result of reviewing the parties' arguments from the first appeal. He did, however, address Beechwood's reading of his findings as reducing the scope and severity levels, as follows:
Second, a facility may not challenge the scope and severity of a deficiency, except in very limited circumstances that are not involved in this case, and I generally have no authority to consider a facility's challenge to a deficiency's scope and severity. ALJ Decision II, at 8. It is thus now clear that the ALJ did not intend to "downgrade" or otherwise evaluate the scope and severity of any of the deficiency findings except to determine whether they presented at least the minimal level required to authorize imposition of a remedy. We find no legal error in this approach to determining substantial compliance and have upheld it in prior cases. See, e.g., Wisteria Care Center, DAB No. 1892, at 16 (2003) (where lack of substantial compliance has been demonstrated, ALJ "not required to make findings regarding the scope and severity of each of the non-immediate jeopardy level deficiencies identified by the surveyors"). Beechwood argued in the current appeal, however, that the very principle that the assigned scope and severity is unreviewable in this case should imply that CMS must prove the assigned level as part of its prima facie case. Beechwood Reply Br. at 4. Thus, according to Beechwood, an ALJ finding that a deficiency existed and presented the potential for more than minimal harm should result in overturning any deficiency that had been cited at a higher level of seriousness, such as actual harm. Id. Beechwood appeared to reason that CMS must somehow have a greater obligation to support its findings on the level of seriousness "actually claimed" precisely because the facility was not permitted to present argument that the actual level was lower. This theory was based on the suggestion that any finding of a level of noncompliance lower than the claimed level would amount to "a violation of the very regulatory principle that CMS says its seeks to preserve: the unreviewability of the scope and severity of a deficiency as alleged in the SOD." Id. This oblique line of reasoning is unsupported by the regulations or any prior decisions of the Board. Moreover, logic contradicts the assumptions underlying it. For an ALJ to find that a deficiency is of a seriousness greater than the minimum level required is in no way equivalent to finding that the seriousness was less than some higher level claimed in the SOD. It would hardly be meaningful for the regulations to insulate the determination of scope and severity from challenge by a facility, if the result was to impose an obligation on CMS to prove the level found in every case without such challenge. We uphold the ALJ's conclusion that, in the posture of this case, he need not decide what level of scope and severity was shown for a given deficiency, so long as the proof supports a scope and severity level that exceeds the minimum required. 8. Beechwood's challenge to the ALJ's overarching "fact evaluation methodology" is without merit. Beechwood made a general assertion that the ALJ used an erroneous standard in evaluating the facts relating to "adverse patient care findings." Beechwood Reply Br. at 5. Beechwood contended that, once the ALJ believed CMS had made a prima facie showing, he ought to have determined whether "substantial evidence" supported the medical findings he made based on "'the record as a whole' - and not selective pieces of it." Id. Beechwood further argued that the ALJ did not "merge medical record details . . . into a coherent medical case history," and left no "audit trail" to show how he compared specific allegations with the actual evidence. Id. This presentation garbles the standard for appellate review of ALJ factual findings, i.e., substantial evidence on the record as a whole, with the standard to be used by the ALJ in making factual findings de novo, i.e., preponderance of the evidence. (12) See Hillman, at n.17. The two Board decisions to which Beechwood cites set out the appellate standard. See San Angelo Regency House, DAB No. 1804 (2001) and Carehouse Convalescent Hosp., DAB No. 1799 (2001). The preponderance of evidence is defined to mean "superior evidentiary weight that, though not sufficient to free the mind wholly from all reasonable doubt, is still sufficient to incline a fair and impartial mind to one side of the issue rather than the other." Black's Law Dictionary (7th ed. 1999). Hence, the ALJ must impartially weigh the evidence presented by both sides and evaluate which quantum of evidentiary weight tips the scales. There is no basis to believe that the ALJ did anything other than this in his general fact evaluation methodology. Where Beechwood complained that the ALJ failed to consider adequately specific items of evidence in relation to particular findings, we address those concerns directly in our discussion of the findings. Here, we conclude that the ALJ made no general error in his legal approach to evaluating the evidence. 9. The ALJ was not required to find that CMS assessed compliance with the DPOC terms as a prerequisite to termination. Beechwood also raised a claim that the ALJ should have imposed a requirement on CMS to show that it assessed Beechwood's compliance with the terms of the DPOC imposed in April as a prerequisite to establishing CMS's authority to terminate Beechwood in June. Beechwood Supp. Br. at 7. Beechwood argued that the DPOC "by law had become part of its provider agreement," implying that this created an additional hurdle for CMS to surmount in order to terminate Beechwood subsequent to a DPOC. As authority for this claim, Beechwood cited to Nazareno, as well as three other ALJ decisions. To analyze this argument, it is necessary to consider two possible categories of deficiency findings in surveys subsequent to the imposition of the DPOC. First, a deficiency may be found where surveyors concluded that a required correction has not been made. Second, a deficiency may be observed that was not previously present or that is unrelated to corrections that have been required. To the extent that a deficiency is based on the failure to make a required correction, an issue may arise as to whether the specific correction requirement was properly imposed. For deficiencies that are not tied directly to some element of the DPOC plan, however, Beechwood presented no persuasive reason why the existence of the prior DPOC would preclude termination based on lack of substantial compliance in the later survey(s). Even accepting arguendo Beechwood's characterization of the DPOC as part of its provider agreement, the effect would be to add a requirement for Beechwood to comply with the provisions of plan, not to preclude CMS from citing the facility for failure to comply with the preexisting regulatory requirements. We therefore reject this general argument. PART TWO: CHALLENGES TO SPECIFIC DEFICIENCY FINDINGS
In this section, we discuss Beechwood's arguments concerning the individual deficiencies upheld by the ALJ. We begin with the findings in ALJ Decision I. First, we deal with those from the May 1999 survey that led to the imposition of the DPNA. Then, we address those from the June 1999 survey that led to the termination of Beechwood's provider agreement. Finally, we deal with Beechwood's challenges to the findings made in ALJ Decision II concerning the April 1999 survey that led to the DPOC. 1. Deficiencies upheld by the ALJ based on the May 1999 survey: The ALJ reviewed two of the ten deficiencies cited in the May 1999 survey and found them sufficient to authorize the imposition of the DPNA. ALJ Decision I, at 20. Beechwood challenged the ALJ's findings regarding both deficiencies.
Beechwood was cited under this tag for failing to notify a resident's family member of an "accident involving the resident which results in injury and has the potential for requiring physician intervention" as required by 42 C.F.R. § 483.10(b)(11). The regulation also requires notice to the family whenever a resident is transferred, which is defined to include any movement of the resident to a bed outside of the certified facility. 42 C.F.R. § 483.10(b)(11); 42 C.F.R. § 483.12(a). The ALJ found that Resident 3 fell on May 5, 1999, and hit her head. ALJ Decision I, at 21. The resident was seen by a physician assistant (PA) who ordered monitoring, and by 3 a.m. the next morning she was complaining of a headache. Later in the morning, the resident was sent to the hospital. Two days later, the resident's relative arrived at the facility only to discover that the resident was in the hospital. Id. The relative said he had not been notified; and no evidence in the record indicated that either the fall or the transfer were reported to the family. The ALJ concluded that these facts demonstrated a violation of the cited requirements. The ALJ rejected Beechwood's three responses. Beechwood did not deny that the family was not notified. Beechwood argued, however, that the surveyor who made observations concerning this allegation was a trainee and hence not qualified to make the findings, that the resident did not sustain "injury" in the sense intended by the regulation, and that the failure to notify of the transfer was an isolated incident causing no potential for harm. On appeal, Beechwood did not dispute any of the facts found by the ALJ. Beechwood reiterated its argument that the ALJ should have given no credence to this surveyor's report because it arose during a monitoring visit just prior to the May 12, 1999, survey. Beechwood considered this relevant because it argued that a deficiency may be determined only during a survey and a monitoring visit is not a kind of survey. Beechwood Br. at 38. Further, Beechwood argued that only deficiencies found to exist at the date of the survey may be the basis for a remedy and this isolated incident predated the survey date. Id. The ALJ did not err in rejecting these arguments. The Board previously has held that a deficiency may be evidenced by events that occurred prior to the actual survey dates. Regency Gardens Nursing Center, DAB No. 1858 (2002). As explained there, particular events disclosed by the facility records may evidence noncompliance with participation requirements, but "the noncompliance - the failure to meet the participation requirement - is what constitutes the deficiency, not any particular event that was used as evidence of the deficiency." Id. at 21, citing 42 C.F.R. § 488.301. Similarly, the observations made on May 8th during the monitoring visit, as well as the records relating to the fall and transfer, were relevant to determining whether the facility notified family members as required. Nothing in the regulations suggests that only a failure to notify that occurs precisely on the days surveyors are present in the facility may be considered in assessing compliance with this provision. In fact, such an interpretation would be inconsistent with the regulations overall which, for example, expressly permit imposition of a CMP for the "number of days of past noncompliance since the last standard survey." 42 C.F.R. § 488.430(b). Moreover, despite its insistence that federal law and regulations were directly violated when an observation made during a monitoring visit was included as a deficiency, Beechwood failed to cite legal authority for this proposition, and we find none. Beechwood Br. at 38. It is true but irrelevant that monitoring visits are not listed as a form of special surveys at 42 C.F.R. § 488.308(e). State monitoring was a remedy imposed on Beechwood as result of the lack of substantial compliance found during the April survey, along with the DPOC. It would be illogical to place monitors in a facility because of concerns about compliance and yet incapacitate those monitors from making observations of incidents that evidence noncompliance with legal requirements. We decline to read into the regulations such limitations on evidence of noncompliance as Beechwood would have us find there. We also agree with the ALJ that no significance attaches to the fact that the surveyor who observed the relative's reaction to learning that the resident was in the hospital after a fall was not yet federally certified. ALJ Decision I, at 21. The observation required no special expertise and, in any case, Beechwood did not dispute the facts observed. As the ALJ stated, the issue is the accuracy of the facts reported in the SOD regardless of who made the observations. Further, Beechwood goes too far when it describes the surveyor as unqualified. The uncontested testimony is that she was a state health care nurse surveyor with 33 years experience in nursing including nine as Director of Nursing (DON) of nursing homes. Pet. Ex. 23, at 1063-65. Beechwood also suggested that this deficiency was later followed up by a federally-certified surveyor who could not find any similar problems. Beechwood Br. at 38. The surveyor worksheet note cited is dated May 10, 1999, and includes a list entitled "To Hospital" showing four names (presumably residents) and notations of "family notified." Ex. M6275. It might reasonably be inferred that no violation was found with respect to these four hospitalized residents. It does not follow that the surveyor's follow-up did not substantiate the violation alleged with regard to Resident 3. The SOD finding, regardless of who "wrote" it, constitutes the collective determination by the May 1999 survey team that the facts reported evidenced a deficiency, not merely the opinion of a "trainee," as Beechwood suggested. Beechwood Br. at 38. Finally, Beechwood objected to the ALJ's reasoning in deciding that the deficiency presented a potential for more than minimal harm. Beechwood Br. at 38-39. While the ALJ agreed that the deficiency proven was isolated, he concluded that it "was not a simple error . . . that caused no potential for harm." ALJ Decision I, at 22. He noted that the resident was absent from the facility for more than two days and that the lack of notification ended only because the relative discovered the hospitalization on a visit. Id. at 22-23. From these facts, the ALJ inferred that the failure to notify would likely have continued longer absent the family member's complaint and that meanwhile the resident was in the hospital isolated from the family, which presented "substantial potential for . . . emotional harm." Id. at 23. Beechwood calls this a "preposterous 'inference'" and "rank speculation" because the hospital apparently did not report any emotional problems. Beechwood Br. at 38-39 (italics in original). It is certainly true that actual harm to the resident was neither alleged nor proven on the record. However, we find that the inferences drawn by the ALJ, relating to the potential for harm, are permissibly drawn from the facts found and are certainly in accord with ordinary experience.
The deficiency findings under Tag F281 cite failures to comply with the requirement that the "services provided or arranged by the facility must . . . [m]eet professional standards of quality." 42 C.F.R. § 483.20(k)(3)(i). The ALJ found that Beechwood failed to provide care meeting those standards in regard to five of six residents about whom CMS presented evidence and argument. ALJ Decision I, at 24. The ALJ further found that the evidence established a pattern of deficient care presenting a potential for more than minimal harm. Id. Beechwood raised legal arguments about the ALJ's evaluation of this tag generally, which we address first, before turning to issues regarding the merits of the findings as to each of the five residents. First, Beechwood argued that the ALJ erred by considering deficiency allegations cited under this tag at all, once he found that the SOD cited to an erroneous subsection. Beechwood Br. at 39; see ALJ Decision I, at 23. According to Beechwood, the result was a fundamental violation of due process, in that CMS effectively changed theories in midstream, denying Beechwood timely notice of the charges against it. The ALJ rejected this argument because he found that Beechwood had adequate notice since the SOD quoted verbatim the correct regulatory language even though the citation was mistakenly written as "42 C.F.R. § 483.20(d)(3)(i)." ALJ Decision I, at 23. In addition, the ALJ noted that the cited subsection does not exist, further assuring that Beechwood would not have been misled as to the requirement being cited. Id. We agree with the ALJ that Beechwood had actual notice of the applicable requirements at issue, despite the evident error of putting "d" for "k" in the citation. Correcting a clerical mistake of this nature can hardly be called changing theories, where the facility had been informed in the SOD itself of the precise language of the regulation with which it allegedly failed to comply. The case cited by Beechwood is inapposite. Rodale Press, Inc. v. FTC, 407 F.2d 1252 (D.C. Cir. 1968), involved a false advertising case which was tried before a hearing examiner based on one theory of liability and then reversed by the Commission based on a "contrary theory." 407 F.2d at 1256. In the present case, Beechwood knew what it was alleged to have done and what language of the regulation that conduct was alleged to have violated well in advance of the hearing and had ample opportunity to seek clarification if it was confused about where in the regulation the quoted language appeared. Beechwood proffered no evidence that it was misled by the miscitation or that it somehow suffered harm from relying on a mistaken understanding of the governing regulation. No real lack of notice thus undercut the process provided to Beechwood. We therefore will not countenance the purely formalistic claim that a typographical mistake must defeat evaluation of the evidence on Beechwood's noncompliance with the regulation. See Cedar View Good Samaritan Center, DAB No. 1897 (2003). Beechwood next contested the ALJ's use of incidents from various dates in reaching his conclusion on this tag. Id. According to Beechwood, this approach "invalidates the whole survey methodology and point-in-time sampling requirements (§ 488.110(d)) which are crucial to the proper evaluation of the requirements." Id. at 39. The regulation cited by Beechwood relates to procedural guidelines for surveyors and specifies how a random sample of residents adequate to represent the distribution of needs and treatments in the population of the facility is to be selected. Beechwood ignored the explicit injunction to surveyors in the same subsection:
42 C.F.R. § 488.110(d). In addition, Beechwood overlooked the many other tasks assigned to surveyors besides the resident sample review, such as observing drug passes, assessing deficiencies alleged by staff or residents, and observing dining and eating assistance. 42 C.F.R. § 488.110 (passim). As we have stated earlier, there is no requirement that all documented events that occurred prior to the survey dates must be omitted from the evaluation of a facility's compliance status. (13) The Board has frequently pointed out, including in its earlier decision in this case, that the appeals process is not intended to review the conduct of the survey but rather to evaluate the evidence of compliance regardless of the procedures by which the evidence was collected. Board Decision I, at 14, and cases cited therein. (14) This is consistent with the major focus of the law and regulations on the protection of residents.
The ALJ found that Resident 5's medical record contained a directive to notify the physician of elevated glucose counts at or above 400. ALJ Decision I, at 26. Yet, there was no record of calls to the physician despite several instances in April 1999 at which the resident's glucose level exceeded 400. Id. The ALJ also found that a PA ordered a change in dosage in an antibiotic to treat an infection. Id. When the dosage ordered was not available from the pharmacy for administration on time, the ALJ found, Beechwood staff allowed a dose to be missed, with the result that the resident experienced a 31-hour delay from the last dose of antibiotic. The ALJ also found that on May 1, 1999, the resident had a high temperature; the physician was called but did not respond and the facility did not follow up until the next day. Id. The ALJ found Beechwood's arguments in response to these facts without merit. ALJ Decision I, at 26-27. He concluded that professional standards of care required Beechwood to notify the physician of the high glucose readings regardless of whether the directive to do so was a signed physician's order. Further, he credited the testimony of CMS's expert physician that the delay in receiving the new dose of antibiotics could have caused significant harm, and he found unpersuasive the contrary testimony of Dr. Foster, Beechwood's medical director. On appeal, Beechwood contested three factual findings. Beechwood Br. at 42-43. First, Beechwood asserted that the unsigned notation in the resident's medical record was not a directive which the nurses had a duty to follow. Second, Beechwood argued that the medical record actually reflects that the nurses did abide by the instructions. Third, Beechwood contended that the bulk of the time between antibiotic doses was deliberately ordered and the additional delay was insignificant. Beechwood also argued that, as a matter of law, the deficiency was improper because the facility is only responsible for reporting "significant changes" to physicians and the nurses correctly judged these changes insignificant, because some of the allegations resulted from monitoring visits, and because the ALJ did not find the level of scope and severity claimed by CMS (actual harm). Id. at 42-44. The specific notation at issue appears in a medication administration record for the resident for the month of April 1999. Ex. M0927. The form contains a section for the medication orders and columns in which to note each day's administration of the corresponding doses. In the section for medication orders, a list of blood glucose ranges appears with the appropriate insulin dose to be given for each 50-point range from 200-400. The next line reads "over 400 10 units call MD or PA." Id. The physician is identified at the bottom of the form as Dr. Foster, the facility's medical director who testified at the state hearing. No physician signature appears on the form. Beechwood hence argued that the nurses need not have taken the directive to call the physician as binding. This position is untenable, however, given that all the directives for administration of insulin were equally unsigned on this form, yet Beechwood did not deny that the nurses were required to follow them. If the nurses had any doubt about the legitimacy of the order, the reasonable course would have been to contact Dr. Foster to verify his instructions rather than simply to ignore one component. In fact, Beechwood itself emphasized that Dr. Foster reviewed the resident six times in April and adjusted the insulin dosage scale twice, citing the medication form. Beechwood Br. at 43. Yet, there is no indication that Dr. Foster questioned or withdrew the reporting directive on the form. (15) We therefore agree with the ALJ that it was a dereliction of duty for the nursing staff to fail to either carry out the directive, or contact the physician about it. Beechwood's position that the nurses actually did carry out the directive is based on reading nursing notes stating that the doctor will be called as equivalent to recording that the doctor was called. Beechwood Br. at 43, citing Exs. M2447, 2449, and 2452. We do not find that the ALJ was obliged to accept this inference. Intending to do something is simply not the same as having done it. It is not disputed that a substantial part of the gap in time between antibiotic doses was the result of the PA ordering that the evening dose on April 24, 1999 be held and the lower dosage begun the next morning. It is equally undisputed that the reason no medication was given the next morning was that the pharmacy failed to provide the new dosage. The result was that no antibiotic therapy was provided from the morning dose until about 3:30 PM on the following day, for a total of one rather than the two doses ordered on April 25, 1999. Dr. Foster testified that delaying a dose of the antibiotic from 9 AM until the afternoon would have "negligible" impact. P. Ex. 3, at 2827. The point the ALJ made about the testimony of the medical director is that it did not address whether missing a dose after skipping the late night dose was more significant than missing a single dose. The ALJ accepted instead the testimony of Dr. Roger Oskvig, (16) who stated that missed doses of antibiotics mean that, for some period of time, "the bacteria is not being treated with antibiotics, and can either make the illness worse or facilitate the development of resistant organisms." HCFA Ex. 19, at 3388. Beechwood argued that the ALJ inappropriately relied on this opinion because in Resident 5's case the antibiotic was "briefly suspended and adjusted downward because the levels were too high." Beechwood Br. at 44, and record citations therein (emphasis in original). This argument overlooked Dr. Oskvig's discussion, preceding his opinion, about the role of "peaks and troughs" in evaluating dosages. HCFA Ex. 19, at 3387-88. The doctor noted that the peak level was therapeutic and should not have been reduced, while the trough level was too high (risking toxicity) and should have been reduced by changing the dosage intervals to more than 12 hours. Id. Instead, the PA's order was to decrease dosage and maintain 12 hour intervals. Id. Given that choice, the inference from Dr. Oskvig's analysis is that extending the interval by skipping two doses (instead of the single dose ordered to be held by the PA), on top of the decreased dosage, would risk reducing the peak level below the therapeutic amount, instead of reducing the trough below toxicity while maintaining effectiveness. Clearly, Dr. Oskvig's opinion about the risks of missing an extra dose was informed by consideration of the peak and trough results for this resident. The ALJ could reasonably conclude that Beechwood did not present evidence sufficient to overcome this analysis and hence that Dr. Oskvig's opinion was more persuasive. We further find Beechwood's legal argument that the regulations require only the reporting of "significant changes" to physicians to be without merit. The regulations nowhere state that the only information which must be reported to physicians is the development of significant changes in a resident's condition. The regulatory section relied on by Beechwood, 42 C.F.R. § 483.10(b)(11)(B), requires consultation with the resident's physician, as well as notification of family members, whenever a significant change in the resident's status occurs. This section was not the basis for this deficiency finding. Instead, the allegation was that Beechwood's care of this resident fell below professional standards of care for the resident under 42 C.F.R. § 483.20(d)(3)(i) in failing to alert the physician that one dose of antibiotic rather than two was delivered on April 25, 1999 and failing to follow a specific directive to report glucose levels over 400 to the physician. Thus, the "significant change" concept is not relevant to this discussion. The last two legal arguments raised are disposed of elsewhere in this decision. We simply reiterate here that it is unimportant that some of the allegations resulted from monitoring visits and that ALJ was not required, or indeed permitted, to revisit the level of scope and severity claimed by CMS.
The allegations concerning each of these residents center on whether Beechwood's nursing staff exceeded their professional role by taking actions without receiving physician orders. The ALJ found that Beechwood's staff administered oxygen to Resident 8 for three days from May 8 through 10 with neither authorization from nor notice to a physician or even PA. ALJ Decision I, at 29. The ALJ further found that professional standards of care require that a nurse independently initiate oxygen only in an emergency, and that even then, a physician must be consulted for further direction. The ALJ rejected Beechwood's defense that the resident needed oxygen for her medical condition and the lack of an order was a clerical oversight when the resident was returned from the hospital. The ALJ concluded that the issue was not whether oxygen was appropriate but why the staff failed to consult with the resident's physician about her need for it. Id. at 29-30. As to Resident 9, the ALJ found that Beechwood's staff inserted a rectal tube without a physician's order, in contravention of accepted nursing practice. Id. at 28. The ALJ concluded that Beechwood did not overcome CMS's evidence of the permissible scope of nursing practice. On appeal, Beechwood argued with regard to Resident 8 that the testimony on which the ALJ relied was inapposite because it referred to the limitations on administration of oxygen in emergency situations. Beechwood Br. at 49. On the other hand, according to Beechwood, the reinstatement of oxygen treatment on the resident's return from the hospital, despite the lack of inclusion of this order in the discharge orders, was justified since the PA confirmed the practice when "advised of the need for a new order" on May 10th. Further, Beechwood argued that the "necessary consultations with the physician" had occurred by the time the survey began on May 12, 1999. (17) Finally, Beechwood argued that no potential for harm existed because this resident did need the oxygen. CMS presented testimony given by Milene A. Sower, R.N., Ph.D., the Executive Secretary of the State Board for Nursing and Respiratory Therapy of the State Department of Education, and a nurse for 35 years. She testified that it would constitute practicing beyond the scope of a nurse's license to administer oxygen to a patient without a doctor's orders, except in an emergency. HCFA Ex. 18, at 343-44. Even after initiating in an emergency, the physician must then be contacted for instructions. Id. Contrary to Beechwood's argument, Dr. Sower expressly stated that in a non-emergency situation "nurses do not start oxygen without an order." Id. at 344. The portion of the SOD cited by the ALJ indicates that the PA was observed to ask nursing staff why the resident was receiving oxygen and the staff was unable to answer, triggering the record review which disclosed that the oxygen had been administered for three days since the resident's readmission from a hospital stay. HCFA Ex. 8, at 8. No order for its administration appeared in the resident's records nor was there any indication of why the oxygen was needed. Id. Beechwood did not argue, or establish, that an emergency situation existed on May 8, 1999, when oxygen was initiated without an order. Even had that been the case, Beechwood presented no basis to justify why the resident's situation precluded contacting the physician for three days and instead merely waiting for a PA to notice the oxygen and inquire about it before any consultation. That the PA ultimately decided that oxygen should be continued does not mean that he retroactively approved its administration before that, nor does it necessarily provide assurance that facility staff would not again take actions beyond their licensed authority. This resident's actual need for oxygen does not vitiate the potential danger of having staff not qualified to do so within the scope of their license making medical determinations about the need for oxygen or the proper dosage, duration, or conditions. Dr. Sower made clear that "[o]xygen is considered a medication." HCFA Ex. 13, at 344. The potential is that nurses could give the wrong dose to the wrong patient at the wrong time if they do not consult with a physician as required and without the oversight required for any "medical regimen." HCFA Ex. 13, at 8. Regarding Resident 9, Beechwood argued on appeal that the physician said that the insertion of a rectal tube was a reasonable thing to do and that he would have given an order if asked. Beechwood Br. at 46-47. Further, Beechwood stated that the SOD did not reference any "written, published and 'widely accepted' guidelines" applicable to the issues and that none existed. Finally, Beechwood argued that the ALJ should have accepted its contention that a representative of the New York State Department of Education orally advised Beechwood staff that insertion of a rectal tube without a physician's order is permissible if authorized by facility policy. The question about whether Beechwood staff was ever orally advised that the need for a physician order could be overridden by a facility policy is a red herring since Beechwood provided no evidence that it had such a policy. To the contrary, Beechwood's medical director, Dr. Foster, testified about facility policy as follows:
P. Ex. 3, at 2877-78. While Dr. Foster opined that he would have ordered the use of the rectal tube in the case of Resident 9, if asked, it was not contested that he was never asked. P. Ex. 3, at 2828-29. In light of Dr. Foster's testimony, it is immaterial whether a facility might ever permissibly authorize its nurses to insert rectal tubes without a physician's order. In any event, Dr. Sower did testify that such a policy would be impermissible. HCFA Ex. 13, at 341-43. Specifically, Dr. Sower testified that insertion of a rectal tube is a treatment that must be ordered by a physician (or authorized prescriber) and that a "facility cannot empower anyone to do anything that is outside the scope of practice that is legitimized in law." Id. at 343. Beechwood argued that the ALJ erred in not finding that its claim that its staff received contrary advice from someone at the Department of Education was corroborated by a notation on the surveyor's notes worksheet reading "Normally do need a M.D. order but if facility has policy is OK." Beechwood Br. at 47, quoting from Ex. M6320. Beechwood did not point to any other evidence directly supporting or otherwise corroborating this claim of oral advice and the ALJ could reasonably infer that the surveyor's note recorded what she was told by Beechwood staff. This is the most plausible inference given that a note just above this records the information about the rectal tube with the statement "No order" with a star next to it and given that the surveyor signed the SOD finding insertion without an order to be improper. Ex. M6320 (emphasis in original). (18) Even if the ALJ had believed that someone at Beechwood did get this advice, Beechwood presented no evidence that its staff had received or relied on this advice prior to inserting the tube or that such advice would somehow override the position of its own medical director. Finally, Beechwood found it "significant that a similar incident on another resident in the April 1999 survey" resulted in a deficiency finding because the physician was not notified, but did not include a "claim that a physician's order was necessary before placement of the tube." Beechwood Br. at 47. To the extent significance can be attributed, it is to the fact that the incident at issue was a virtual repetition of one cited in a prior survey, suggesting a continued lack of training of the staff in facility policy and professional practice. In fact, Dr. Foster testified about this incident as follows when asked to state which allegations he considered non-trivial:
P. Ex. 3, at 2913. Beechwood did not dispute that "something like that" did happen subsequently. We find substantial evidence in the record to support the ALJ's findings concerning these two residents.
The ALJ found that this resident was admitted to the facility post-pelvic fracture with a Foley catheter in place on May 6, 1999, at which time the physician's order for care stated that the catheter "may be removed after three to four days." ALJ Decision I, at 24. It is undisputed that the catheter was not actually removed until May 12, 1999, six days after admission. CMS presented evidence that a facility nurse stated in an interview that "she had just become aware of the physician's order concerning the catheter." Id. at 24-25. The ALJ noted that the medical record reflected that the resident had been pulling at the catheter on May 8, 1999, suggesting discomfort, and concluded that the evidence established that the facility was inattentive to the physician's order. Id. at 25. The ALJ was not persuaded by Beechwood's argument that the physician's orders only permitted but did not require removal of the catheter within three to four days, leaving the timing in the staff's discretion. Id. The ALJ accepted that the precise timing was discretionary, but concluded that the delay here was not an exercise of discretion but merely an omission because "the staff forgot to remove it," and hence violated professional standards of quality care. Id. On appeal, Beechwood argued that the ALJ's conclusion about the failure to exercise discretion by omitting to remove the catheter was an attempt to "rehabilitate" the allegations of the SOD which focused solely on the theory that removal in three to four days was mandatory. Beechwood Br. at 40. Beechwood contended that the credence given to the hearsay report of the nurse's statement was unfounded and improper in the face of the direct testimony of the nurse herself. Id. at 40-41. (19) According to Beechwood, the information about the resident pulling at the catheter does not demonstrate any potential for harm, since it occurred before the survey began and before the three/four day period had even ended. Id. at 41. The allegations in the SOD stated that the hospital transfer order and the medical orders written in the facility both "indicated that the catheter should be removed in 3-4 days." The SOD further stated that -
HCFA Ex. 8, at 4. The LPN testified at the State hearing that she had primary responsibility for the resident, that the general goal at the facility is to avoid catheters to avoid infection, and she personally had removed the resident's catheter. P. Ex. 13, at 2213. The LPN testified that "[a]t some point" she became aware of the order, having been off duty when the resident was admitted. She further stated that before removing the catheter, she had multiple discussions with the charge nurse and other staff as follows:
Id. at 2214. She also explained that the resident was incontinent and demented so that after removal of the catheter it was necessary to toilet him frequently and to roll him over to remove wet pads from the bed. Id. at 2214-19. She denied that the removal of the catheter on May 12 resulted from the surveyor's raising a question about it, and stated she was aware only that an order was obtained from Dr. Foster that day to discontinue the catheter. She stated that she had felt such an order was a prerequisite. Id. at 2224-26. Finally, she stated that the concerns that she had regarding when to remove the catheter would not necessarily have been documented. Id. at 2227-28. CMS countered that the rationale for not removing the catheter was the "post hoc rationalization of self-interested individuals" and that the expert testimony of its nurse-surveyor gave ample support for the ALJ's conclusion that leaving the catheter in without documenting the need and without consulting the physician violated accepted standards of practice. CMS Br. at 40. The surveyor testified as follows about proper care of the catheter based on an order that the staff "may remove in three or four days" after admission, and given the nursing records of this resident during the period from May 6-12, 1999, as follows:
HCFA Ex. 17, at 1132. The actual instructions appear in two places in the record. The transfer form instructions read: "May D/C [discontinue] when patient more comfortable x 3-4 d[ays] c [with] attempt spontaneous." (20) P. Ex. 32, at M0352. The Beechwood physician's order sheet reads: "Foley to gravity drain c [with] care q.s. [in sufficient quantity]. Max DC [discontinue] in q 3-4 days." Id. at M0353. On their face, the orders are not definitive as to whether the intention was to remove the catheter in no more than four days or simply some time after that time. The testimony is in conflict concerning why the nursing staff did not remove the catheter on May 8th or 9th, as contemplated by the order, and whether the delay was discretionary or required consultation with the physician. Faced with conflicting evidence, the ALJ's role as the finder of fact was to determine which testimony he believed, what weight to give the various items of evidence, and which permissible inferences to draw. We do not serve as a second bite at that same apple, but rather have a different role as appellate reviewers. We conclude that, based on the record as a whole, the ALJ was reasonable in concluding that, while the order permitted leeway on the precise timing of the removal and on delaying if warranted by the resident's condition, the delay here was caused because the staff forgot to remove the catheter, rather than because of a conscious exercise of this discretion based on evaluating the resident's condition after three or four days. Since the ALJ's findings are supported by substantial evidence in the record, we will not disturb them or substitute any alternative interpretation of the evidence.
The ALJ found that this resident injured her ankle in a fall and an x-ray showed no fracture, but ten days later the surveyors found the resident walking and complaining of pain. ALJ Decision at 27-28. The ALJ further found that the medical records did not document follow-up evaluation of the injury or notification to the physician of continuing complaints of pain. The ALJ rejected Beechwood's argument that ankle pain and swelling were part of the expected course of recovery and did not require additional follow-up by the physician. The ALJ stated that this argument begged "the question of what Petitioner's staff was obligated to do for the resident," concluding that the "dereliction in duty" was by the facility staff not by the physician. Id. at 28. The ALJ concluded that, even if the physician would not have altered the plan of care, Beechwood's staff had still "deprived the physician of information that he should have received." Id. at 28. On appeal, Beechwood argued that the ALJ ignored medical records that establish that the physician was notified of the sprained ankle, and had assessed and planned care for the ankle, as well as to prevent other injuries. Beechwood Br. at 45-46 In addition, according to Beechwood, numerous progress notes and care plan annotations entered between the date of the fall on May 3, 1999 and May 28, 1999 demonstrated careful monitoring and ongoing assessment and also showed that the resident had no unexpected difficulty during recuperation. Id., citing Exs. M1767, M2127-30. The care plan, after the x-ray results found no fracture, called for physical therapy "consult with follow-up per plan," use of an air splint, and ambulating "with walker and one assist to tolerance." Ex. M1767. The annotations to the care plan thereafter did not note any problem from the date of the x-ray results until May 24, 1999, when the resident was observed to have blisters from the air cast, which was then discontinued and measures taken to treat the blisters. Id. The progress notes show bruising, swelling and "great pain" in the morning after the day of the x-ray. Ex. M2127. The following day the physical therapy consult requested by the nursing staff took place. Ex. M2128. Notes appear for May 5, 7, 9, and 12, 1999, the last being the survey date. Id. These notes show the resident ambulating without difficulty and refusing medication for pain at some times and receiving good relief from Tylenol at other times. On May 12, 1999, at 3:06 P.M., the progress notes record the following: "Pt. c/o [patient complained of] pain in left ankle today. Acet. [acetaminophen] 650 mg given x 1 for pain with good effect." Id. Beechwood also pointed to testimony from Dr. Foster about the resident's course of treatment that supported its contentions. P. Ex. 3, at 2616-22. Dr. Foster reported that, after the resident fell, he or his physician assistant ordered that the resident stay off her foot and have ice put on it for 24 hours, and that the ankle be x-rayed in the morning. Id. at 2616. The x-ray report noted soft tissue swelling with no gross fracture and was initialed by Dr. Foster. Id. at 2618; Ex. M1011. He testified that he would not necessarily physically examine a resident for a sprained ankle and would not expect to have a follow-up examination unless persistent difficulty was brought to his attention by a nurse. P. Ex. 3, at 2619-20. He noted that the resident received an air splint from the physical therapist and opined that it was appropriate for her condition and did not require a physician's order. Id. at 2618-19. Finally, he testified that no follow-up visit earlier than the regular 30-day re-assessment which occurred on June 2, 1999, was necessary, "because she apparently had made satisfactory progress and was convalescing as one would expect." Id. at 2621-22. Contrary to what the ALJ found, the facility records and testimony do not support the finding that Beechwood staff had "not evaluated the resident's continuing condition." Cf. ALJ Decision at 27. Yet, the ALJ gave no reason for disregarding that evidence. CMS argued before us that Beechwood had admitted the facts about the fall and that the resident complained of pain on May 12, 1999. CMS Br. at 44. The deficiency at issue, however, does not relate to any circumstances of the fall but rather to whether the treatment of the injury met professional standards of care. It is not self-evident that pain in walking ten days after a sprained ankle implies unprofessional care. Hence, the observation of that fact does not alone suffice to substantiate the deficiency. Neither the ALJ Decision or CMS's briefing identified any evidence of record conflicting with Dr. Foster's testimony that the course of recuperation was normal for an ankle sprain, that no unexpected problems were shown that would require a physician follow-up, and that the physical therapy intervention was appropriate. The SOD originally noted the lack of a physician's order for the air splint but neither the ALJ Decision, nor CMS on appeal, relied on this claim, and Dr. Foster's testimony rebutted it. See HCFA Ex. 8, at 7. CMS also relied on a statement in the SOD that the x-ray was not signed by the physician at the time she saw it on May 12, 1999. Id. CMS cited Dr. Foster's testimony as showing that he did not know when he actually initialed the x-ray. CMS Br. at 44, citing P. Ex. 3, at 2618. However, Dr. Foster also testified that he sometimes got results via telephone or fax and then might not "initial the hard copy" for a week or more. Id. CMS pointed out that Dr. Foster's testimony that physician follow-up would not be needed absent "persistent difficulty" was premised on the nurses alerting the physician to the continuing problem. The problem with CMS's position is that CMS did not show that the initial swelling and bruising and the sporadic reports of pain in the ten days before the survey visit constituted "persistent difficulty" that should have been reported to the physician, rather than the expected course of recovery. Dr. Foster's testimony was expressly that the latter was the case and that the recorded course did not call for physician follow-up. The ALJ stated that he was not reviewing the physician's conduct but that of the facility staff. As the ALJ stated, the question regarding the staff was "what they were obligated to do for the resident." ALJ Decision I, at 28. We find nothing in the record that answered this question with obligations beyond what was provided (monitoring, support in returning to ambulation, medication offered for pain, splinting of the ankle, consultation with physical therapy, and monitoring of progress in comfort and ambulation). CMS simply did not establish that a follow-up visit from the physician was the standard of professional care in this situation or that, if not, unexpected developments in this case nevertheless demanded seeking more physician direction. We conclude that the ALJ's finding as to this resident is not supported by substantial evidence on the record as a whole. We therefore reverse FFCL 4.b.iv. We expressly conclude, nevertheless, that the other ALJ findings under this tag, which we have concluded are supported by substantial evidence in the record, are more than sufficient to demonstrate that Beechwood was not in substantial compliance with the regulatory requirement cited. 2. Deficiencies upheld by the ALJ based on the June 1999 survey:
Beechwood was cited under Tag F324 in relation to five residents for failure to meet the standards required by 42 C.F.R. § 483.25(h)(2). This regulation contains requirements relating to the provision of quality care; and the subsection at issue provides that a "facility must ensure that . . . each resident receives adequate supervision and assistance devices to prevent accidents." The ALJ found that CMS had not established even a prima facie case in relation to one of the residents, but found that Beechwood failed to prove that it was in substantial compliance with this requirement as to the other four residents, referred to by numbers assigned during the survey as Residents 9, 15, 16, and 17. ALJ Decision I, at 14-19. The ALJ explained his view of the regulatory requirement as follows:
ALJ Decision I, at 14-15. Beechwood raised a general argument that it was error for the ALJ to opine that a violation could be found where the lack of supervision presented a risk of harm without necessarily having resulted in an accident actually occurring. Beechwood Br. at 29. In prior decisions, the Board has thoroughly considered and rejected the concept that an accident is a prerequisite to a deficiency finding under section 483.25(h)(2). See, e.g., Price Hill Nursing Home, DAB No. 1781 (2001) ("The intent of the regulation is to prevent accidents; thus, the fact that no accident occurred because no resident touched the unattended cart or the unlocked supply closet does not establish compliance with this regulation."); Woodstock Care Center, DAB No. 1726, at 17 (2000), aff'd Woodstock Care Ctr. v. Thompson, No. 01-3889 (6th Cir. 2003) ("[O]bservations and the occurrence of events other than accidents may suffice to expose the absence of supervision adequate to prevent accidents."). The Board has pointed out introductory language in 42 C.F.R. § 483.25 (that a facility "must provide the necessary care and services to attain or maintain the highest practicable . . . well-being, in accordance with the comprehensive assessment and plan of care") in upholding deficiency findings where a facility failed to follow steps in a plan of care that were directed at preventing accidents. See Coquina Center, DAB No. 1860 (2002). We therefore consider next whether any authorities cited by Beechwood require us to revisit our prior holdings. Beechwood relied first on the State Operations Manual (SOM), which gives procedural guidance to surveyors concerning this tag. Beechwood Br. at 29. Specifically, Beechwood excerpted references to what the surveyors are to do if a resident "has had an accident" or the survey team "identifies a pattern of accidents," and instructions to look in such situations at the facility's planning and efforts to prevent accidents. SOM, App. PP, at PP-104-05. While correctly citing these excerpts, Beechwood overlooked the broader statement of the intent of the requirement, i.e., that the facility "identifies each resident at risk for accidents and/or falls and adequately plans care and implements procedures to prevent accidents." Id. at PP-104. This reading appears to imply more than mere retrospective reviews of post-accident situations. The examples of questions for the surveyors to consider include whether residents who smoke are adequately monitored, with no suggested limitation to instances where fires or burns have occurred. The best interpretation is that the SOM sensibly instructs surveyors that one approach to determining if proper supervision and devices are being provided is to look closely at accidents that have occurred, but that the SOM does not restrict the application of this tag to accidents as opposed to the presence of conditions of inadequate supervision where the facility is not acting to ensure accident prevention. Beechwood also quoted out of context from general regulatory instructions to surveyors about how to compose a deficiency statement. See Beechwood Br. at 29. The full quotation referenced tells surveyors to -
42 C.F.R. § 488.110(i)(4). Beechwood questioned how a surveyor could cite the facility for its practices or procedures where there has been no accident to prove that a practice is deficient and given that the "provider is responsible for deciding on and implementing the actions necessary for achieving compliance." Beechwood Br. at 29, quoting 42 C.F.R. § 488.110(m). Nothing in these provisions in any way requires surveyors to ignore dangerous conditions which they observe unless an accident has already occurred. The discussion of the role of the surveyor in the cited regulations makes clear that the focus is to be assessing "the quality of care and services and [relating] those findings to statutory and regulatory requirements for program participation." 42 C.F.R. § 488.110(m). The surveyor is expected to explain the reason for a deficiency finding to the facility officials but is not expected to try to discover why a deficient condition was allowed to occur or make specific recommendations about how to fix it. Id. This approach is entirely consistent with the overall regulatory scheme, which gives providers leeway to achieve compliance by different methods appropriate to particular facilities and residents, so long as the methods practiced result in the requirements being met. See Koester Pavilion, DAB No. 1750 (2000). We find no authority to support Beechwood's contention that somehow a fatal flaw arises when a surveyor who made observations relevant to a deficiency finding does not personally draft the language of the deficiency finding in the SOD. The regulations and the SOM throughout envision the surveyors working as a team in ascertaining and citing particular deficiencies.
The ALJ found that this resident was at high risk of choking for several reasons and that a physician had ordered one-on-one feeding. ALJ Decision at 15-16. He further found that a surveyor's observation of the resident trying to drink coffee alone evidenced inadequate supervision and presented an obvious risk of choking. Id. The ALJ rejected Beechwood's response that a speech pathologist had concluded that the resident could consume thickened liquids without supervision and that the coffee was thickened. The ALJ reasoned that Beechwood did not show that the physician modified the feeding order or deferred to the speech pathologist's opinion. Further, the ALJ found that the speech pathologist actually opined that the resident could be fed thickened liquids by family members but did not say that no staff needed to be present. ALJ Decision at 16, citing Ex. M2087. Beechwood asserted that (1) the ALJ should have credited testimony by a facility nurse that she was speaking to the surveyor as the resident was being fed (so the resident was not alone); (2) had the surveyor really thought that a risk of harm existed, she would have intervened and she did not (so there must not have been any risk); and (3) the surveyor knew the coffee was thickened (so that the resident "could not have been at risk"). Beechwood Br. at 30-10. The testimony of the facility nurse on which Beechwood relied related to a different citation regarding the same resident. See P. Ex. 12, at 2537-40. The nurse was alleged to have touched the resident to cover up a wet area on the resident's bib and to tuck the resident in, and then to have left the room, all without washing her hands or wearing gloves. The nurse asserted that she had been feeding the resident breakfast, left with the tray, and went to the kitchen to get a glass of thickened ice water. P. Ex. 12, at 2538-39. The surveyor did not testify as to whether she had previously talked with the nurse while she fed breakfast to the resident. The nurse's testimony is not necessarily inconsistent with that of the surveyor that the resident was left alone with coffee until the nurse entered and took the cup away and dealt with the spill on the bib. See HCFA Ex. 12, at 1259. To the extent that the versions of events conflict, the ALJ was within his discretion to give greater weight or credence to the surveyor's version. Even where witnesses' testimony is submitted in written form, so that the ALJ does not directly observe demeanor, the ALJ may reasonably make judgments about what testimony to believe and what weight to assign. The fact-finder must resolve conflicting testimony in some way, where it cannot be understood in a manner that removes the inconsistencies. This may be done by assessing plausibility, evaluating the overall coherence of a witness's account, considering what interests or bias a witness may have, looking at other corroborating or conflicting evidence in the record, and so on. Beechwood did not refer to any evidence in the record concerning whether or not the surveyor intervened. The SOD, however, stated that a nurse entered as the resident spilled the coffee on herself (and that the nurse informed the surveyor when asked that the brown liquid was coffee). Id. The surveyor hence could reasonably expect the staff nurse to take appropriate measures at that point. The surveyor's notes indeed mentioned thickened coffee, but this is not inconsistent with the SOD, which stated that the resident was alone in her bed when the surveyor entered and observed her trying to put a cup of brown liquid to her mouth to drink and pouring it on her bib. Compare M6130 with HCFA Ex. 9, at 6-7. There is no claim in the SOD that the resident was fed unthickened liquids. The allegation is that the resident was left alone with a cup of coffee against the orders of her doctor and against the directions of the care plan prepared by the facility for this resident. Beechwood did not deny that the care plan stated that the resident was to be closely supervised while eating and fed one on one by staff. HCFA Ex. 9, at 7. Beechwood did not establish that it was safe to leave the resident unsupervised to drink liquids as long as they were thickened. Beechwood again relied on the speech pathologist, quoting a statement in a progress note from that individual stating that if the resident "remains on honey thickened liquid, . . . she will not be at risk." Beechwood Br. at 31. (21) The ALJ fully discussed the context and import of the progress note. ALJ Decision I, at 16. The note reports that family members had continued to feed the resident free-flowing liquids causing the resident to cough. HCFA Ex. 44, at 11. The speech pathologist states that the doctor has changed the liquid diet to honey-thickened consistency and also that the family insisted on feeding her still. The progress note concluded:
Id. Clearly, the speech pathologist addressed a strategy to minimize problems created by the family's unwillingness to abide by the care plan. Nowhere does she assert that the resident could safely ingest liquids without supervision so long as they were thickened. Leaving aside the question of whether the speech pathologist was empowered to unilaterally supersede the physician's order, there was ample evidence in the record to support the ALJ's conclusion that the resident was at risk for choking when left alone to drink any fluid. Finally, Beechwood raised a legal objection to the application of this tag based on language from the SOM to the effect that adverse outcomes that are a direct consequence of treatment or care will not be considered accidents. Beechwood Br. at 31. The actual provision reads:
SOM, App. PP, at PP-105. The examples make explicit that this language addresses the situation where the provision of care itself necessarily includes a risk of adverse outcomes. It is plain that the regulation would be rendered meaningless if it were read to exclude accidents occurring due to lack of supervision in the provision of care or services, as Beechwood suggested. We find no basis in any of these arguments to reject the ALJ's findings about this incident.
The ALJ found that the facility identified this resident as at risk for falls due to unsteady gait and severe cellulitis in one leg. ALJ Decision I, at 17; see also HCFA Ex. 9, at 5. The care plan provided that, to prevent injury, the resident should walk with a walker and with assistance from one staff member. Id. The resident fell in her room during the night of June 5, 1999 and had to be taken to the hospital. Id. The resident had earlier reported to a surveyor and an LPN, during a May 20, 1999 monitoring visit, that she had almost fallen (22) trying to get to the bathroom at night. Id. The LPN reportedly told the resident that she should not have been ambulating alone. Id. The resident stated that she tried to call for assistance in toileting but that it took too long for help to come. Id. The ALJ rejected Beechwood's contentions that (1) it properly investigated and reported the fall; (2) the resident got the supervision specified in her care plan; (3) the resident was progressing in her ability to walk; and (4) the resident wanted greater independence, while interventions to prevent her going to the toilet alone at night (such as a bedside commode or bed alarm) would have interfered with that desire. Id. The ALJ concluded that the resident was not provided with the supervision or assistance devices she required to avoid falls and that nothing in the resident's records suggested she no longer needed or wanted assistance ambulating. Id. On appeal, Beechwood assigned several errors. First, Beechwood argued that its reference to its own investigation was not intended to assert that its only duty of care lay in investigation but rather to highlight the surveyor's failure to make an independent personal investigation, relying instead on facility records about the incident since the resident had already been transferred before the June 1999 surveyor arrived. In particular, Beechwood alleged that the surveyor failed to discover from the facility's assessments and care planning review that "the resident's status was upgraded to independent in mobility and toileting as well as all other Activities of Daily Living." Beechwood Br. at 32. In addition, Beechwood asserted that the surveyor failed to determine the discharge plan for the resident, who was admitted for post-surgical rehabilitation, which Beechwood contended would have made clear the appropriateness of increasing the resident's independence. (23) Further, Beechwood argued that the ALJ erred by disregarding the resident's right to refuse treatment and toilet herself at night. Beechwood Br. at 34. While the regulations place a high value on resident autonomy, e.g., 45 C.F.R. § 483.10, Beechwood failed to substantiate any issue of self-determination here. There is no evidence that the resident refused assistance and, on the contrary, there is evidence in the record (which the ALJ credited) establishing the resident's frustration at not receiving prompt assistance when she asked for it. See ALJ Decision I, at 18, citing HCFA Ex. 5, at 9. The parties disputed before us whether some significance should attach to a medical record numbered M2446 and appended as part of Attachment 18 to Beechwood's brief. Compare CMS Br. at 31-33, with Beechwood Supp. Br. at 11-12. Above, we admitted these documents for the sake of a complete record but do not find anything in them sufficient to undercut the substantial evidence in the record supporting the ALJ's findings regarding this resident. On its face, the cited page is a change summary report printout showing the resident's mobility level as "needs some help" as of May 18, 1999 and "walks unsupervised" as of May 27, 1999. Ex. M2446. Beechwood argued that this showed that the resident's status was "upgraded on May 27, 1999 to independent in mobility." Beechwood Br. at 32. From this, Beechwood reasoned that this showed improvement consistent with the care plan for this resident since she was planning to return home. Although CMS did not object to the admission of this record, it questioned the reliability of it given that the resident's care plan continued to call for the resident to "[a]mbulate with the assist of one, using the walker, to tolerance." Ex. M1932. We conclude that the single page excerpt submitted by Beechwood does not establish that the resident did not continue to require some form of supervision or assistance devices to prevent falls when trying to walk alone to the toilet at night. The record evidence includes more than simply the care plan on this point. For example, the resident informed the staff in front of the surveyor that she felt she had to wait too long at night for needed assistance with the result that she was attempting to go to the toilet alone and had almost fallen. Beechwood did not prove that it took any measures to provide assistance, whether in the form of assistance ambulating, a bedside commode, a bed alarm, pre-bed toileting or any other measure. See HCFA Ex. 12, at 1256. Finally, Beechwood argued that this incident could not be used to support a deficiency finding because it occurred a week before the June 1999 survey began. Beechwood Br. at 34. As we have already explained above, documented events from before a survey may be relevant to whether a facility is in compliance and surveyors are not limited to considering only events that occur before their eyes on the days they are present at a facility. Here, we note that accident prevention is one area especially unlikely to be captured fairly by considering only events occurring over one or two days. The review of care records and accident reports is an appropriate part of determining whether conditions at the facility are inconsistent with the participation requirements. The ALJ could properly consider, therefore, whether the undisputed fact that Resident 15 fell while attempting to ambulate alone in her room at night evidenced a failure to provide sufficient supervision and assistance devices to the resident. In reaching his conclusion on that point, he could properly consider the evidence about the concern expressed by the resident at the prior survey, as well as her medical situation and care plan, to determine whether the facility should reasonably have anticipated the need for timely assistance with nighttime toileting to prevent falls. Based on these considerations, we find that his conclusion that this episode showed that the facility provided lax supervision leading to a fall causing injury is supported by substantial evidence. The last comment of Beechwood on this resident is hard to comprehend, i.e., that this resident's fall cannot "be used to support a deficiency because the resident "was the only one cited out of the original sample with any fall concerns." Beechwood Br. at 34. We find no requirement that more than one of the residents at risk of falls must be shown to have actually fallen in order to make the fall of that one resident potentially relevant. The SOD does state that during the June 1999 survey, the surveyors determined that "3 of 9 residents identified by the facility as being at risk for falls did not have an adequate assessment and care plans developed to prevent falls," but that only Resident 15 suffered actual harm. HCFA Ex. 9, at 5. The SOD also noted that two residents were placed at risk for accidents due to the way they were bathed (as discussed in the next section). Id. We fail to see how those statements in any way relieve Beechwood of responsibility for taking appropriate measures to prevent the resident from falling.
The ALJ found that two residents in two separate incidents on June 10, 1999 were left alone while being bathed in a Century mechanical bathtub. ALJ Decision I at 18-19. He further found that leaving these residents unsupervised in the Century tub presented risks to them, including drowning. Id. The ALJ found that the manufacturer's manual, replete with warnings about potential hazards and the need for staff training to operate the special bathing equipment, implies that no patient should be left alone, even if, as Beechwood argued, that statement does not explicitly appear in it. Id.; Ex. M1921. The ALJ rejected Beechwood's contention that Resident 16 was capable of being left alone safely for a brief period. Id. The ALJ found that Beechwood's attacks on the credibility of the surveyor who observed Resident 17 left alone for five minutes made no difference, since Beechwood did not deny that the resident was left alone for some period of time. Id. The ALJ concluded that "[l]eaving a resident alone for even a short period of time while partially submerged in water is not 'safe.'" Id. at 19. On appeal, Beechwood raised a number of points in regard to these residents. Beechwood Br. at 34-37. First, Beechwood argued that the ALJ's description of the residents as "frail and infirm" was misleading because he did not refer to their assessment records to determine what bathing assistance each needed. Second, Beechwood argued that the facility had used the Century tub for many years without an incident or any citation in prior surveys, and disputed the ALJ's inference that the residents were placed at risk of drowning. Third, Beechwood contended that the ALJ's finding that Resident 17 was "left alone" was too "expansive." Id. at 37. Finally, Beechwood attacked the surveyor's truthfulness. None of Beechwood's arguments persuades us that the ALJ's findings are not supported by substantial evidence in the record as a whole. Beechwood's argument that the surveyors and the ALJ did not reference federal or state assessment forms before describing the residents as frail and infirm is unaccompanied by any citation to those assessments or other medical records to contradict the descriptions. It was undisputed that Resident 16 was 90 years old, post-stroke, and had paralysis of the left side and that Resident 17 was 97 years old, visually-impaired and had dementia. The ordinary meanings of the words frail ("having a delicate constitution") and infirm ("physically weak, especially from old age") seem entirely apropos. See Webster's New Riverside Univ. Dictionary at 503 and 627 (1984). Beechwood also made the point that a disability in bathing independently does not automatically flow from being frail or infirm. Beechwood Br. at 35. Both these residents, however, had care plans indicating that they needed assistance with bathing. HCFA Ex. 12, at 1242-43; Ex. M2084 (Resident 16 - "Supervise and assist with ADLs [activities of daily living] as necessary); Ex. 2086 (Resident 17 - "Requires assist with bathing and dressing"). (24) Beechwood cited no evidence to substantiate its claim of 24 years of use of Century tubs without an incident. Beechwood Br. at 34. Certainly, Beechwood did not establish that its staff had safely left residents alone in the Century tub all these years. The surveyor reported that both the head nurse and the DON told her that, while there was no house policy, the staff should know that "people should not be left alone because of safety reasons." HCFA Ex. 12, at 1249; HCFA Ex. 9, at 6. In fact, the DON confirmed on the stand that it was not the policy of the facility to leave residents alone in this apparatus. Pet. Ex. 2, at 3272-73. (25) Even taking Beechwood's asserted track record as true, Beechwood's experience alone could hardly establish that the "potential for harm was so low statistically as to be nonexistent." Id. In addition to the manufacturer's manual warnings of the dangers of burns, injuries and drowning from various errors in use of the specialty tubs, (26) the record included testimony and other evidence on which the ALJ could reasonably rely in reaching his conclusion about risk. For example, one surveyor testified that she was aware of two people electrocuted in a Century tub in Texas. HCFA Ex. 12, at 1247. Another surveyor described a personal experience with the difficulty of handling patients who slide in the hydraulic tub seat. HCFA Ex. 17, at 1609-11. Both explained that an unsupervised patient could slide under the water level, could suffer a stroke or faint, or could accidently change the water flow or temperature. HCFA Ex. 12, at 1247-49l; HCFA Ex. 17, at 1608-1612. Both nurse-surveyors testified that the standard of care in nursing homes was that no patient should be left alone in a Century tub. HCFA Ex. 12, at 1250-52; HCFA Ex. 17, at 1610-11. The ALJ's inference that drowning was a risk of leaving these residents alone in the Century tub was a permissible one from the facts and testimony in evidence. That inference is not made unreasonable by any of the points put forward by Beechwood to contradict it. (27) Beechwood did not dispute that each of these residents was left alone for some period of time while in the bathtub. Beechwood Br. at 37; Beechwood Post-hearing Br. in C-99-582, at 22. The surveyor observed Resident 16 alone in the tub when she followed a nurse aide into the bathing area in response to the resident's calls that he had been in too long. HCFA Ex. 9, at 6; HCFA Ex. 12, at 1245. At another time, the surveyor entered the bathing area and noticed that the nurse aide removing Resident 17 from the tub was one the surveyor had just observed in the resident's room laying out clothes. HCFA Ex. 9, at 5-6. When asked where the resident had been while that was done, the aide told the surveyor that the resident had been in the tub. Id.; see also HCFA Ex. 12, at 1242-43. Beechwood contended that being left alone by a nurse aide was not the same as simply being left alone, because the bathing suite "contained another bath tub and shower, as well as an adjoining toilet area." Beechwood Br. at 37. This contention has no merit, given that Beechwood offered no evidence that any staff person was in the suite at the relevant times, much less that staff members attending to residents using any of the other facilities could have adequately supervised use of the Century tub at the same time. (28) Beechwood accused the surveyor of "falsifying the timing and content of the observations she claimed to have made." Beechwood Br. at 37. The ALJ found that any "apparent discrepancies" in the surveyor's accounts of the length of time for which Resident 17 was alone did not matter since the fact that a "97 year old demented individual with impaired vision" was admittedly left unsupervised while partially submerged was enough to present obvious risks regardless of whether the period was five minutes or longer. ALJ Decision I, at 19. Beechwood argued on appeal that the surveyor's account was not credible because her observations were "of events that happened outside of the bathing suite." Beechwood Br. at 37 (emphasis in original). This argument is inconsistent with the actual testimony that the surveyor entered the bathing suite and saw Resident 16 alone. HCFA Ex. 12, at 1244. Beechwood also stated that the surveyor was not credible because she had to ask Resident 17's aide "where the resident was." Id. Beechwood here distorts the testimony. The surveyor reported seeing the aide bathing Resident 17, and asking where the resident had been a few minutes before while the surveyor had been having a conversation with the same aide elsewhere. HCFA Ex. 12, at 1243. Finally, Beechwood implied that it was somehow damning that the surveyor "supposedly interviewed an aide . . . in order to 'validate' what had happened" in regard to Resident 16. Beechwood Br. at 37. The surveyor did not report interviewing an aide to validate the surveyor's own observations, but rather later locating the nurse aide who had placed Resident 16 in the tub and confirming that the aide had left the resident there alone. HCFA Ex. 9, at 5. The SOD clearly stated that this was a different aide from the one who responded to his calls for assistance. Id. We see no reason to disturb the ALJ's decision about what credit he gave to the surveyor's testimony.
This tag involved another subsection of the quality of care regulation, 42 C.F.R. §§ 483.25(c)(2), which requires the facility to ensure that no new pressure sores develop unless clinically unavoidable and that existing pressure sores are treated to promote healing and prevent infection or additional sores. CMS alleged that Beechwood failed to meet these requirements in relation to Residents 12 and 1. In each case, the ALJ found that Beechwood failed to consistently implement and assess the effectiveness of measures to heal sores and prevent new ones from developing. ALJ Decision I, at 13. The ALJ also rejected Beechwood's claims that both residents' sores were clinically unavoidable as irrelevant, because CMS did not allege that the sores were avoidable but rather that the facility failed to implement necessary measures to treat existing sores and prevent additional ones. Id. In addition to arguments relating to the individual residents, Beechwood contended that "any finding of deficiency under this regulation is to be 'based on the comprehensive assessment of a resident.'" Beechwood Br. at 24. According to Beechwood, the deficiency should be vacated because the surveyors did not "perform an RAI [resident assessment instrument] review" on either resident. Id. Beechwood contended that the surveyors were required under 42 C.F.R. § 488.25(c) and (d) to use HCFA Form 805 for this purpose. Id.; see Ex. M6179-80 for cited form. In this regard, Beechwood misconstrued the thrust of the cited regulation which speaks to the obligations of the facility in caring for patients, not the surveyor's procedures in evaluating care. The form is required by section 483.20(b)(1) for use by facilities in assessing systematically the needs of each resident. The regulation at issue provides that the facility must provide the care and services to meet the needs identified by the assessments and addressed in the care plans required by the preceding section. It follows that the compliance to be evaluated by the surveyors is that of the facility in providing quality care that meets the needs identified by the facility in a proper assessment and care planning exercise. Contrary to Beechwood's argument, we thus find no general error in the ALJ's focus on whether the facility failed to provide care of a quality adequate to prevent or treat pressures sores in accordance with its assessment of the residents' needs in this area. Cf. Beechwood Br. at 24; ALJ Decision I, at 13. We turn next to the allegations concerning individual residents.
The ALJ found that, even though Resident 12 was "highly susceptible to developing pressure sores," Beechwood's staff failed to take the necessary steps to prevent new sores from developing. ALJ Decision I, at 13. CMS's evidence sufficed to establish that Resident 12 had a prior history of pressure sores while at Beechwood, and the care plan called for continued use of lamb's wool booties to prevent sores on the resident's heels. The surveyor reported seeing Resident 12 in bed for two hours on June 10, 1999, with shoes on and with the booties lying unused nearby, and also reported observing reddened areas on both heels and stage II pressure sores on the buttocks. The next day, the surveyor again saw the resident placed in bed without protective devices for an hour. The surveyor reported that the charge nurse was unaware of the new pressure sores. The ALJ concluded that Beechwood's "staff was not attentive to the resident's condition and allowed him to remain in the same position for relatively lengthy periods of time." Id. at 13. The ALJ found that Beechwood's evidence of various interventions planned or taken to avoid new sores failed to overcome the surveyor's observations of inconsistent implementation. On appeal, Beechwood argued that the surveyor's assertions were mistakes or outright lies. Beechwood Br. at 24-25. Beechwood arrived at this position partly by interpreting raw surveyor notes as conflicting with the allegations in the SOD, generally by assuming that the surveyor was writing down a description of an observation rather than a notation of an unmet obligation. For example, Beechwood asserted that "surveyor Saner falsely testified that this resident 'still had his shoes and socks on' from 1:15pm to 3:00pm on 6/10 . . . while her actual notes confirm 'pm have booties on' for that same period of time." Beechwood Br. at 25 (citations omitted). The surveyor testified that she observed this resident left in one position either in a wheelchair or in bed without being turned or moved. HCFA Ex. 17, at 1591. She also stated that the resident was in bed with his shoes and socks on when the treatment plan called for lamb's wool booties. Id. at 1592. Beechwood argued that this testimony was directly contradicted by this surveyor's handwritten notes for the day of the observations, which read "confirm 'pm have booties on'" for the period from 1:15 PM to 3 PM. The relevant section of the surveyor's notes in context reads as follows:
Ex. M6181 (bold emphasis added). The highlighted language could mean that the resident had booties on in bed in the afternoon observation, as Beechwood suggested, but could also mean other things, such as that the resident was in bed in the afternoon and should have had booties on. Beechwood cross-examined this surveyor at the State hearing (P. Ex. 24, at 1627-4), but failed to question her about the meaning of her notation, even though Beechwood was already in possession of the notes. Beechwood defended its failure to cross-examine surveyor witnesses on the worksheet notes on two bases. First, Beechwood stated that the notes were not turned over until the State hearing was underway and then Beechwood required "many months" to sort through and decipher the notes. Beechwood Br. at 10, n.7. Second, Beechwood contended that the notes speak for themselves in undercutting the integrity of the surveyors and CMS should have called its surveyors as in-person witnesses before the ALJ to explain the discrepancies. Beechwood Br. at 10. Neither argument is persuasive as a reason that the ALJ was obliged to credit Beechwood's interpretations of the notations over the surveyors' testimony. While Beechwood may well have required time to digest the notes, ample time passed before the federal hearing. While Beechwood pointed to CMS as having failed to call the surveyors as witnesses, Beechwood itself was free to, and chose not to, call them as witnesses and confront them with excerpts of the worksheet notes. This omission might well be harmless if Beechwood were correct that the notes on their face unambiguously contradicted the surveyors' testimony. In this instance, as well as in many others which we have not discussed in detail, we find that the ALJ could reasonably have considered the notes ambiguous, unclear, or cryptic, or have interpreted them in a manner other than that suggested by Beechwood. We conclude that Beechwood has shown no reason to disturb the ALJ's judgments in weighing the testimony and the worksheet notes. Beechwood also argued that its care of this resident was satisfactory, despite the uncontradicted observation of the resident in bed for a long period with shoes and socks on instead of the booties required in the facility's own care plan. Beechwood Br. at 25. The grounds on which Beechwood relied were basically two-fold. First, Beechwood asserted that the facility was taking other measures which were appropriate, such as using a gel cushion and an eggcrate mattress and giving whirlpool baths and barrier cream treatments. Id. Second, Beechwood relied on evidence that the treating physician was "satisfied with the general level of care" provided by the staff to the resident. Id. We find no error in the ALJ's reasoning that evidence that Beechwood took some appropriate measures does not rebut evidence that Beechwood omitted other measures, also called for by the resident's assessment and care plan. Further, as the ALJ pointed out, "as satisfied as the physician may have been with the general level of care that Petitioner's staff gave to the resident, she did not rebut the specific allegations that, on June 10 and 11, 1999, staff was deficient in providing prescribed care to the resident." ALJ Decision I at 13. We conclude that the ALJ's findings as to Resident 12 under this tag were supported by substantial evidence on the record as a whole.
The ALJ found that this resident had "persistent pressure sores on the coccyx and the left foot." ALJ Decision I, at 13. He further found that Beechwood failed to assess why the sores were not healing under the care being provided and to "explore treatment alternatives that might promote healing." Id. He rejected Beechwood's position that no reassessment was required because no significant change took place in the resident's condition, ruling as follows:
Id. On appeal, Beechwood argued that the physician reassessed the resident's condition frequently and did not order changes in treatment, so the nursing staff should not be held legally responsible for providing any other services for the resident. Beechwood Br. at 28. Beechwood argued that the services ordered by the physician and provided by the facility consisted of cream, Granulex spray and Duoderm to treat the coccyx sore and an "easy boot" for the left foot. Id. Beechwood reasoned that the deficiency was not supported given that:
Id. The testimony of Dr. Foster was that on May 20, 1999, he ordered use of an easy boot and Duoderm to treat "a one-centimeter Stage I area on the lateral aspect of her left foot and several tiny Stage II presacral areas." P. Ex. 3, at 2843, citing physician progress notes at Ex. M1913. He further testified that his PA described the left foot sore on June 11, 1999 in terms that indicated that the area "had developed a blood blister." P. Ex. 3, at 2844-45, citing Ex. M1915. Dr. Foster testified that the condition was not substantially changed because the skin was still not broken (which he would consider still Stage I) and because a blister might develop in the "natural course of healing." P. Ex. 3, at 2846-47. The actual PA note, from June 11, 1999, states that the patient was seen at nursing staff's request to evaluate necrosis of the left foot, describes the sore as 1.5 cm by 1 cm. and as a Stage I-II decubitis. Ex. M1915. The surveyors reported that nursing notes from May 14, 19, 20, and 25 and June 8, 10 and 11 document the lack of improvement in the blackened area on the left foot (reported as 1.9 cm by 1.4 cm by June 10) and the development of an additional sore on the right buttock on June 1. HCFA Ex. 9, at 3-4. Dr. Foster's testimony, like the arguments proffered by Beechwood on appeal in reliance on it, focused on whether these changes were so substantial as to trigger a requirement for a new assessment. The regulation involved in this citation, however, does not address whether a timely re-assessment has been performed (which falls under section 483.20) but rather whether the facility ensured that the resident received necessary treatment and services to promote healing, prevent infection and prevent new sores from developing unless clinically unavoidable. The persistence and spread of the existing sores and the development of new problem areas raises an inference that more could and should have been done. To overcome this inference, Beechwood had to show that it took steps to ensure that the resident received those services reasonably considered "necessary" under the particular, and the sores nevertheless could not be healed or prevented, i.e. that they were clinically unavoidable. It is possible that the mistaken focus in Beechwood's arguments was partly attributable to the way the deficiency finding was phrased in the SOD. HCFA Ex. 9, at 3. The allegations concluded with the following sentence: "There has been no change in the plan of care related to the coccyx area, which has worsened, nor has the left lateral foot been assessed to determine if further treatment is warranted." The remainder of the allegations nevertheless made it sufficiently clear that the surveyors were concerned that the facility's treatment had failed to stem the persistent and growing pressure sores that the resident had experienced while under the care of the facility and not merely with the quality of the assessment or planning. The facility hence had to show not merely that it planned and took some steps toward treating or preventing the sores, but that it ensured that services and treatment were provided as "necessary" to heal existing sores and prevent new infections and sores. This the ALJ found that Beechwood failed to do; and we find no error in that result. The ALJ could reasonably conclude that simply continuing existing measures in the face of the clear lack of improvement and the development of additional sores does not demonstrate that additional treatment and services were not necessary.
This tag involved the overarching language at the beginning of 42 C.F.R. § 483.25 which requires that a facility provide each resident with care and services necessary for the resident to "attain or maintain the highest practicable physical, mental, and psychosocial well-being in accordance with the comprehensive assessment and plan of care." The SOD alleged that Beechwood failed to comply with this requirement in treating Resident 7's surgical wounds in a manner that breached aseptic techniques and by inadequately managing Resident 3's back pain. HCFA Ex. 9, at 2-3.
The ALJ found that the physician prescribed daily changes of sterile dressings for the resident's multiple wounds, yet a surveyor observed staff changing the dressings using improper technique. ALJ Decision I, at 9-10. In particular, the facility staff person allowed the resident's foot which had unhealed wounds to rest on a metal footrest of the resident's wheelchair during a dressing change. Id. at 9. When the surveyor questioned whether this breached aseptic technique, a bed pillow, itself non-sterile, was placed under the heel. Id. at 9-10. The ALJ concluded that Beechwood did not overcome this showing that its staff failed to provide sterile dressing changes and thus increased the risk of infection. Id. at 10. He rejected Beechwood's position that the dressing change was to the toes while only the heel was in contact with the non-sterile surfaces, so that no breach of aseptic technique occurred. Id. He found the testimony of Beechwood's former DON to this effect less than persuasive because she was not present when the dressing change was observed and she did not fully rebut the surveyor's report that the foot itself, not merely the heel, was in contact with the footrest. Id. On appeal, Beechwood argued the ALJ erred in finding that wounded areas of the foot touched the footrest, because the SOD did not specify the "entire foot." Beechwood Br. at 22. Beechwood asserted that surveyor's notes record merely that the "nurse rested foot on metal foot rest -- pressure on the right heel." Id., citing Ex. M6165. This language admitted of the interpretation that only an uninjured portion of the foot was in contact, according to Beechwood, which the former DON testified would not have been problematic. Further, Beechwood contended that the ALJ relied on a potential adverse outcome (possible infection) that was not stated in the SOD and that should have been cited under a different tag. Id. Beechwood also contended that no deficiency should have been cited, even assuming all the facts were as alleged, because the surveyors did not report problems with other residents whose dressing changes were observed. Finally, Beechwood argued that the ALJ's finding of a potential for more than minimal harm was inconsistent with his holding in a prior case that found no deficiency resulting from a nurse's use of non-sterile technique in wound care. Id. at 24, citing Mediplex of Massachusetts, d/b/a Randolph's Crossing Nursing Center, DAB CR584 (1999)(Mediplex ALJ Decision). (29) As to the first point, we find that the ALJ's construction of the surveyor's first-hand observations is supported by substantial evidence. The SOD states that "the nurse allowed the resident's foot (with a draining wound) to rest directly on the metal footrest of the wheelchair" and that, when questioned, the nurse put the pillow "under the foot, placing the open wound in direct contact with the pillow." HCFA Ex. 9, at 2-3. The SOD alleged as follows:
Id. at 3. The assertion that the SOD did not mention the "entire foot" is a red herring since the SOD clearly alleged that areas with open wounds were among the parts of the feet that contacted non-sterile surfaces, which is the essential issue. Even were we to consider the distinction important, the surveyor testified in more detail about the episode, stated that "[w]hen the nurse prepared her dressings to do these treatments, she removed the sterile dressing from the resident's right foot and the entire foot was resting bare on the metal footrest, resting down." HCFA Ex. 17, at 1600. The cited surveyor's worksheet notes are not in necessary conflict with the SOD, which simply contained an amplified description of the observation. The ALJ could reasonably conclude that the report of the first-hand observation by the surveyor was more credible than the after-the-fact explanation of the former DON. As far as evidence that the potential for harm was from infection, it was not unreasonable for the ALJ to understand the allegation that aseptic technique was breached to imply that the risk of infection was increased, since it is common knowledge that one purpose of aseptic technique is to minimize the danger of wound infection. (30) The ALJ also could reasonably accept the testimony of the surveyor, who was qualified as having 31 years of nursing experience, that what she saw was "a breach in following aseptic technique to prevent further infection for that resident" which deviated from "standard practice" taught in every nursing school. HCFA Ex. 17, at 1125-26, 1604-05. Beechwood's claim that any deficiency should have been cited under Tag F442 is unavailing. First, since we find the ALJ's conclusion that Beechwood was not in substantial compliance with the cited regulatory requirement to be well-supported, it is irrelevant if the facts could also make out a deficiency under a different provision. Second, it is not obvious that Tag F422 is apropos, since the regulation involved has to do with preventing the spread of infectious disease among residents and/or staff by such means as isolation, handwashing, and programs to prevent and control disease transmission. 42 C.F.R. § 483.65(b). The issue at hand is not person-to-person spread of disease but potential infection of an open wound by environmental pathogens due to lack of aseptic handling. The argument that this deficiency was not properly cited because other observations of wound care did not demonstrate the same problems is also unpersuasive. Briefly, there is no requirement that surveyors find multiple instances of improper care in order to cite a deficiency, although how widespread a problem is has relevance in the assessment of scope and severity. Certainly, the absence of other observations of similar conduct does not serve to disprove that the conduct observed actually occurred with respect to this resident. Our conclusion here is analogous to our earlier conclusion that it is irrelevant to finding of actual harm to one resident, that other residents sampled were not alleged to have suffered harm. We also note that, although only one resident was involved, there were several breaches of aseptic technique observed. Finally, Beechwood's reliance on the Mediplex ALJ Decision is misplaced. As the ALJ pointed out, his decision in Mediplex merely held, based on expert testimony and the specific factual situation, that aseptic technique in cleaning was not required by standards of practice where the physician had not ordered its use and the wound was closed. Neither of those conditions was present here, since the treating physician had ordered aseptic care and the foot wounds were open and draining. We conclude that the ALJ's findings about this resident were supported by substantial evidence on the record and were free of legal error. We further conclude that those findings suffice to show that Beechwood was not in substantial compliance with the cited requirement.
A surveyor observed this resident complaining of severe back pain on June 10, 1999, and found that the resident's prescription for pain relief was last changed on April 30, 1999, from Vicodin to Percoset as needed, as well as regular doses of Flexeril and Ibuprophen and ice packs. HCFA Ex. 9, at 2. CMS alleged that no assessment of the persistent pain had been made since April 30, 1999. Id. The ALJ accepted CMS's evidence that Beechwood did not provide sufficiently aggressive management of the serious back pain this resident was experiencing, despite treatment with medication and ice packs. ALJ Decision I, at 8-9. It was not disputed that Beechwood followed the physician's orders in its treatment, but the ALJ concluded that Beechwood failed to show that its staff "perform[ed] ongoing assessments of the resident's complaints of pain and communicat[ed] its findings to the physician, along with suggestions for possible changes in the resident's treatment, in order to maximize the resident's pain relief." Id. at 8. The ALJ stated that he did not "question the diligence of Petitioner's staff in providing prescribed care to Resident No. 3," and did not dispute Beechwood's argument that the resident's medical records showed that the resident did obtain relief after receiving the medication and ice packs. Id. The ALJ emphasized, however, those records also showed continuing "episodes of severe pain in early June 1999" bad enough at times to "interfer[e] with her appetite or prevent[] her from participating in activities. Id. at 9. The ALJ also rejected Beechwood's argument that this allegation sought to impose a "duty to second guess the diagnosis made by a resident's physician," contrary to the ALJ's prior decision in Beverly Health & Rehabilitation - Spring Hill, DAB CR553 (1998)(see subsequent history discussed supra). On appeal, Beechwood argued that the ALJ's conclusions were contrary to the weight of the evidence, noting in particular that the medical staff had re-assessed the back pain on May 14, 1999, and ordered continuation of the medication regime and that the source of the pain was not unknown but reflected in a diagnosis of chronic back pain with a lengthy history. Beechwood Br. at 18. Further, Beechwood argued that the SOD, and the surveyor's testimony, were unclear about whether the alleged inadequacy had to do with the nursing care or with the physician's medical care, for which it was not responsible. Id. at 18. Further, although the resident did experience some episodes of pain, Beechwood contended that these were infrequent and were responsive to the medication. Id. at 18-19. Finally, Beechwood argued that no harm or potential for harm existed because the pain was being monitored by staff and by the resident's physician (or PA), and effective treatment was being provided. Thus, Beechwood reasoned, the mere fact that the resident "was not totally pain free is not a deficiency in care." Id. at 22. The resident was admitted with diagnoses of degenerative joint disease, chronic low back pain, and chronic urinary tract infection. Ex. M1388. The record shows reviews of the back pain and medication by the PA at the request of nursing staff on April 19th and 30th (at which time the medications were changed), after an initial care plan set up with physician's orders on April 6th. Exs. M1387-90. In addition, Beechwood sent the resident to the hospital on April 23, 1999, for treatment of the back pain and other complaints. HCFA Ex. 40, at 8l. Physician progress notes dated May 14, 1999, record a visit by the PA to this resident at which continuation of the medications was ordered. P. Ex. 37. The ALJ did not explain why this evidence did not demonstrate that the medical personnel were monitoring treatment choices and effectiveness on a regular basis. The nursing notes do show a number of episodes of serious pain during April, May and early June 1999. See, e.g., Exs. M1391-93; HCFA Ex. 40, at 5-29. It is also evident that the recurrent severe back pain indeed forced limitations on the resident's participation in activities and in therapy activities. Id. The notes also reflect, however, that relief of pain usually occurred within a hour or two after the prescribed medication was provided, especially after the shift in medications on April 30th. Id. The nurses regularly report that they will continue to monitor the pain situation. Id. In addition, the record shows that interventions in addition to medication were also tried, including ice packs, warm compresses, and physical therapy. HCFA Ex. 40, at 7-10. The care plan included occupational therapy to teach various management and movement techniques to reduce pain and increase independence. Ex. M1399. On May 13, 1999, the nurse noted that the resident complained of back spasms and observed that she received medications and cold compresses. Id. at 13. The nurse evaluated the situation as follows:
Id (sic). Evaluations and nursing observations relating to pain control were noted on May 15, 16, 18, and June 4. The ALJ did not explain why this evidence did not demonstrate ongoing assessments by Beechwood's staff of this resident's back pain. The real gravamen of the concern here is that all the efforts undertaken did not prevent periods of severe pain from recurring, including the episode observed by the surveyor on June 10, 1999, in which the resident was "rolling back and forth in bed and complaining of severe back pain." HCFA Ex. 9, at 2. It was not disputed that Beechwood provided the treatment prescribed by the physician whenever the resident suffered pain, however, and the ALJ did not question the staff's diligence in providing care. What the ALJ faulted Beechwood for, i.e., not serving as the "physician's eyes and ears" by "making observations and assessments of the resident's condition and communicating the findings to the physician," cannot reasonably be established solely by evidence that the resident was still in severe pain at times. ALJ Decision I, at 9; see also P. Ex. 4, at 2182 (physician testifying that facility nurses serve as her eyes and ears). While that observation may well raise questions about whether the staff was identifying the problem, treating the pain, and monitoring the course of treatment, Beechwood came forward with evidence in answer that showed that it was doing so. It is not clear from his decision that the ALJ evaluated this evidence fully. Indisputably, minimizing and managing pain is an important aspect of ensuring physical and mental well-being. The responsibility is necessarily shared between the nurses who provide daily care and thus must indeed be the "eyes and ears" and the physician who must determine what additional medical approaches, if any, can be tried in the face of intractable and continuing pain. Here, the surveyor testified that her concern was that the pain medication had not been changed in "almost a month and a half" and that she expected that "somehow this lady would have been diagnosed as to what the problem was with her back, and then, depending on what the problem was, for staff to explore what other things might be able to be done to help this lady with her pain." P. Ex. 20, at 1336-37. Yet, the surveyor also acknowledged that diagnosis and prescription of medication are within the province of the physician, and stated that when she "was saying 'staff,' [she] was meaning physician staff . . . ." Id. at 1337. The record shows, moreover, that the resident had a diagnosis of degenerative joint disease (as well as chronic back pain); the surveyor did not explain why the continuation of some pain would require a new diagnosis. Nor did the surveyor's testimony indicate that she was fully aware of documentation in the record that 1) nursing staff had explored alternatives for pain relief including occupational and physical therapy, rest, and application of heat and cold; and 2) the medical staff had not only, within the preceding month and a half, changed her medications, but had also reviewed and made a recorded decision to continue with those new medications. Indeed, the record indicates that the surveyor's review of this resident was not as thorough and persuasive as her review of other residents. We conclude that the record as a whole simply does not contain substantial evidence to support a finding that the facility staff fell short in monitoring the situation and involving the medical staff in seeking maximum pain relief for this resident. (31) We therefore reverse the ALJ's findings regarding this resident. 3.
Deficiencies upheld by the ALJ
on remand from the April 1999 survey:
The ALJ on remand reviewed the six deficiency findings made during the April 1999 survey. (32) He upheld deficiencies under Tags F224, F324, and 490, and overturned the three other alleged deficiencies. Beechwood appealed the three deficiency findings upheld by the ALJ. (33) We address first the errors that Beechwood claimed concerning the ALJ's general analysis of this survey, and then analyze each of the specific deficiency findings challenged by Beechwood. Beechwood argued as a general matter that the relative quality of the witnesses presented before the ALJ in relation to the April 1999 survey should have compelled resolution of the contested issues in favor of Beechwood. Specifically, Beechwood asserted that "four attending physicians" reviewed the allegations and medical records and "testified that the medical and nursing care provided to these residents was appropriate, and indeed, of high quality." Beechwood Br. at 50, citing P. Ex. 21, at 3918-19; Exs. M6014-15, M5001, and M5003. By contrast, according to Beechwood, CMS presented only a nurse surveyor and one "outside physician," and did not present any "staff physicians from either DOH or HCFA" even though "those doctors had been involved in evaluating the records and coaching the development of the deficiency claims." Id. Further, Beechwood contended that the nurse surveyor was not credible, and that Dr. Oskvig, who testified for the State, conducted a "last minute, incomplete record review." Id., citing P. Ex. 29, at 3428-33. The documents cited by Beechwood do not support its assertions. The testimony cited at Petitioner's Exhibit 21 from pages 3918-19 is part of the cross-examination of one of the surveyors in which she states that the determination that one of the deficiencies constituted immediate jeopardy was reached only after review of the resident's record by an in-house physician at the State DOH. Exhibit M5001 is an internal memorandum between employees of the State DOH dated April 27, 1999, discussing Beechwood and expressing "grave concerns about the care" and an "obligation to the residents to stick to our guns," and including a statement that the DOH medical director is supporting them "from a medical sense." Exhibit M5003 appears to be handwritten notes on a conference call dated May 11, 1999, to the general effect that termination was expected and a transition plan for the residents was needed. This evidence may establish that DOH physicians were indeed involved in evaluating the medical care of the residents at issue but it also undercuts the inference Beechwood would have us draw from the State's failure to present in-house DOH physicians - that they did not find the care to be deficient. Moreover, none of the transcript citations given by Beechwood establish "four attending physicians" found that care to be "high quality," as Beechwood claimed. Since the State hearing transcript is in the record only in the form of excerpts submitted by each party, the record does not permit us to independently evaluate whether such testimony was in fact given. Beechwood also failed to provide citation or argument to support its flat assertion that the surveyor was not credible. We therefore do not address it further here, although we do discuss specific testimonial conflicts, where relevant, in dealing below with arguments about the three deficiencies upheld by the ALJ. At the State hearing, Beechwood challenged Dr. Oskvig's expert testimony on the basis that the doctor did not have access to Beechwood's entire electronic medical records as to the residents whose care he reviewed, but looked only at materials provided to him by DOH, consisting of progress notes, medical records, and certain letters by Dr. Foster concerning the residents' care. HCFA Ex. 19, at 3427-31. Dr. Oskvig also testified, however, that he received the materials the Friday before the hearing and spent time studying them over the weekend, and that he did not talk to or review testimony of the treating physicians prior to his own appearance. Id. at 3428, 3433, 3436. Beechwood had ample opportunity to cross-examine Dr. Oskvig about any additional medical records or other information which it thought relevant to determine if those would alter the expert's opinions. Therefore, we do not see that the information about the bases for Dr. Oskvig's opinions in any way undermines the ALJ's decision to rely on those opinions. Here, as well as in general argument, Beechwood asserted that the ALJ erred by "ignoring" the testimony of attending physicians which Beechwood argued should have greater weight based on prior case law. Beechwood Br. at 17 (citing Koester Pavilion, DAB No. 1750) and 50. Koester does not, however, stand for the proposition that the opinions of attending physicians must always be given greater weight than those of outside expert witnesses. Rather, in Koester, the Board rejected CMS's argument that, once she accepted a surveyor as an expert witness, the ALJ had to defer to the surveyor's testimony in preference to that of facility staff. Koester at 21-23. In that case, the Board pointed out that "much of the testimony which HCFA argued should have been accorded more weight went not to expert opinions but to observations of facts [and that on] . . . such matters, the question of expertise is not necessarily relevant." Id. at 22. The contrary is the case here. That is, much of the testimony which Beechwood argued should have been accorded more weight went not to conflicting observations of fact or accounts of events (much of which was established in any case by written records), but rather to questions about the proper standards of professional care. The ALJ could reasonably accord more weight on those issues to the testimony of a doctor on the State Board dealing with professional conduct. We conclude that Beechwood provided us with no reason to disturb the ALJ's judgments as to which testimony to credit and how much weight to assign to conflicting evidence. Beechwood also raised general arguments about the April survey findings which we have already discussed sufficiently elsewhere and hence reject summarily here. Thus, we find no merit to Beechwood's arguments that deficiencies could not properly be found based on record review unless current residents were shown to be affected at the date of the survey (34); that the ALJ erred by not determining the scope and severity of the findings (other than immediate jeopardy); and that the ALJ erred by not reviewing whether the "the deficiencies justified the termination remedy imposed," rather than merely sufficing to authorize the remedy. Beechwood Br. at 50-51. In fact, the remedy imposed based on the April findings was not termination, but a directed plan of correction. The initial termination was postponed and was imposed only after the May and June surveys. This fact, however, does not alter our analysis that the ALJ is not empowered to second-guess the choice of remedy for a facility that is not in substantial compliance.
The regulation under which immediate jeopardy was found is 42 C.F.R. § 483.13, which requires that a facility develop and implement written policies and procedures that prohibit mistreatment, neglect, and abuse of residents. (35) The ALJ concluded that the instances of neglect of residents identified by the numbers 1, 2, 3, 4, and 6, viewed collectively, established a pattern sufficient to establish an overall failure to implement policies and procedures to prohibit mistreatment and neglect, resulting in more than minimal harm. Id. at 11. The episodes consisted of failing to notify physicians of significant, even potentially life-threatening, changes in residents' conditions and/or administration of unauthorized treatments such as oxygen or rectal tube insertion. Id. at 10-11. The ALJ held that Beechwood did not rebut the evidence of mistreatment or neglect of these residents. Id. at 11. Before reaching the individual allegations, Beechwood asserted that the ALJ committed an error of law by "arbitrarily and capriciously augmenting what the surveyors actually wrote and claimed." Beechwood Br. at 51. Beechwood based this assertion on the ALJ having described the uncommunicated changes as "significant," while the SOD only referred to a "change" in medical condition. Id. Beechwood described the ALJ as thereby lowering the threshold for requiring notice to physicians below the regulatory standard of significant change. Further, Beechwood asserted that the definition of significant change required "a life-threatening condition, not a 'potentially' life-threatening condition." Id. The effect, according to Beechwood, was that "nearly any change" could meet a "potentially life-threatening" test, thus "stripping the nursing staff of any discretion" before calling the physician. Id. at 53-54. The logic of Beechwood's arguments is inconsistent with a careful reading of the definition of significant change (which is not limited to "life-threatening" situations) and of the ALJ's statements. He did not introduce a lower test for physician notification, but rather concluded that the incidents at issue in fact met at least the standard of involving "significant" changes, and that some rose to an even higher level of potentially threatening the lives of the residents. Furthermore, the SOD relied on detailed discussions of the treatment history, needs, and omissions as to each resident and the risks and outcomes which CMS cited as demonstrating the seriousness of the alleged neglect. HCFA Ex. 7, at 1-14. The presentation cannot reasonably be described as merely alleging insignificant "changes" in condition, just because the introductory language does not specify that the changes were significant. Id. at 1. Beechwood suggested alternative regulatory requirements which it indicated would have been more appropriately applied. Beechwood Br. at 51-53. Beechwood argued that the claims of neglect require a showing that goods and services that were necessary to avoid physical or mental harm were withheld and are to be cited under Tag F223, not Tag F224. If the focus is on a pattern physician notification, Beechwood asserted, then the allegations "should have been framed under F157." Id. at 53. These arguments do not affect our analysis. It is not our task (nor that of the ALJ) to determine whether CMS could properly have made out a case under uncited regulations based on the facts of record. Instead, we need determine only whether the ALJ had substantial evidence in the whole record to support his factual findings and whether he committed legal error in evaluating them against the regulatory requirements under which Beechwood was cited. Here, the crucial question is whether the various alleged failures to notify physicians or seek their input prior to administering treatment amounted to a pattern of neglecting or mistreating residents that demonstrated that the required policies and procedures had not been effectively implemented. Beechwood further argued, however, that the ALJ erred in aggregating the findings concerning individual residents in order to conclude that collectively they established a violation of the cited regulation. Beechwood Br. at 52. The SOD stated that the deficiency finding was based on "staff interviews and record reviews." HCFA Ex. 7, at 1. The SOD continued that half of the closed records reviewed (five out of ten), as well one of six current residents, showed omissions of needed assessments, monitoring, or physician notification. Id. On this foundation, the SOD concluded that no procedures were implemented to prohibit neglect. Id. The ALJ, thus, did not go beyond the SOD allegations by viewing the residents' experiences collectively in assessing whether effective policies and procedures were implemented. Nor was the ALJ's conclusion here inconsistent with his statement in a prior case that he would not infer a failure to implement an anti-neglect policy "from proof of a random incident or incidents of neglect" at a facility. Beechwood Br. at 52, citing Beverly -- Spring Hill, DAB CR553 (1998)[aff'd DAB No. 1696 (1999)]. In that case, as here, the ALJ concluded that the multiple findings involved were not random incidents but rather revealed a widespread pattern. Contrary to Beechwood's position, the ALJ's statement that each episode "viewed individually" might not violate the regulation was not inconsistent with his determination that the series of events collectively show a violation. Beechwood Br. at 52, citing ALJ Decision II, at 10. Repeated similar occurrences may well demonstrate a failure to implement policies or procedures that is not evident from single or unrelated episodes. See Barn Hill Care Center, DAB No. 1848 (2002). Beechwood argued that "an essential predicate element" was missing in that CMS did not identify specifically "what policies were not being implemented." Beechwood Br. at 52 (italics in original). The essence of CMS's case here, though inelegantly presented in the SOD, distills down to the depiction of residents suffering abrupt health declines or serious episodes which were not addressed by the staff or followed up on with physicians, leading to the conclusion that the staff was not following any policies or procedures that would prevent such neglect. CMS did not specify whether that was because there were no written policies or procedures on point, or because the staff was unaware of their provisions, or because the staff knew about but was not abiding by policies and procedures that were in place. Nothing about the requirement demands that the surveyors distinguish these alternative causes, and it may not always be possible to do so. The striking point is that Beechwood's appeal does not point to any written policies or procedures prohibiting mistreatment and neglect nor to any evidence of their implementation. Presumably, Beechwood would be in the best position to know if it had adopted such measures and if it had taken steps to implement them. (36) Further, Beechwood argued that the ALJ erred in upholding this deficiency without having made a finding as to whether the immediate jeopardy level was justified. Beechwood Br. at 54. We have discussed and rejected above the general contention that the ALJ may not sustain a finding unless he expressly finds that the level of scope and severity accords with CMS's allegations. Here, we note that the analysis is not altered by the fact that the ALJ did not make a finding about whether the scope and severity constituted immediate jeopardy but rather simply found that the deficiency constituted noncompliance. The regulations, as noted above, do permit challenge to the level of noncompliance where an immediate jeopardy finding justifies imposition of a CMP above $3,000. No CMP is involved here, however. Furthermore, we see no logical reason why that expanded ability to challenge scope and severity level in such circumstances implies that a deficiency cited at the immediate jeopardy level may not be sustained as showing noncompliance, without resolving whether the immediate jeopardy level applies, where, as here, the immediate jeopardy finding did not result in imposition of an otherwise unavailable remedy. Beechwood also argued that the decision-making process in the preparation of the SOD evidenced that the immediate jeopardy determination "was concocted" because the surveyors did not originally consider coding the finding at that level. Beechwood Br. at 54. In the present posture of this case, no real consequence attaches to whether or not immediate jeopardy existed since the DPOC may be imposed for any level of deficiency with the potential for more than minimal harm. 42 C.F.R. § 488.408(c). It is thus irrelevant at what point in its deliberations the State DOH determined to cite this deficiency at the immediate jeopardy level.
The ALJ found that this resident had been getting sicker during his stay at the facility and had been sent to the hospital more than once. ALJ Decision II, at 11. He was sent briefly to the hospital for evaluation on February 9, 1999, and he died on February 16, 1999. Id. The ALJ found that CMS presented evidence that the resident underwent serious deterioration over that week, including such symptoms as fever, blue lips and nails, possible fecal contamination in his urine, and difficulty breathing. Id. Yet, the ALJ found no evidence that the resident's physician was notified of these changes. In addition, the ALJ found that CMS offered evidence that the resident received oxygen administration and had a rectal tube inserted without authorization from a physician. Id. at 11-12. The ALJ rejecting as unpersuasive Beechwood's three arguments in response to this prima facie case. The ALJ concluded that Beechwood's claim that it had a very detailed care plan for the resident's many medical challenges might be true but was inapposite to the issue of whether Beechwood neglected the resident's needs during the week in question. Id. at 12. The ALJ also rejected as not credible the claim that the physician was in ongoing communication with nursing staff during that week but the "conversations were not and need not be documented" because none of them resulted in any change in treatment. Id. Finally, the ALJ rejected the arguments that the oxygen and rectal tube administration was pre-authorized or that the degree of physician involvement was actually appropriate. Id. On appeal, Beechwood's main argument centered on the view that the resident was "imminently terminally ill, essentially precluding the possibility of a 'significant change.'" Beechwood Br. at 56. Yet, Beechwood failed to respond to testimony of CMS's expert physician that a physician informed of the various developments, such as brown matter appearing in the resident's urine, could have instituted interventions that might have led to a different outcome and that the facility's actions "imperiled this patient's care." HCFA Ex. 19, at 3413-14. Beechwood asserted, however, that the ALJ "ignored the testimony of [the resident's] two physicians, who both testified that this resident was terminal, death was imminent and not preventable, and no additional medical or nursing interventions were required between 2/9 and 2/16." Id. at 55. The testimony of Dr. Foster merely adopted a letter he sent to the State DOH. P. Ex. 3, at 2586-87. The letter stated that the hospital had concluded, in returning the resident to Beechwood, that nothing more could be done, that he felt progressive worsening of the resident's severe pressure sore was predictable, that "bowel perforations" found at the hospital could have had many plausible causes, and that he did not feel that the resident's "decline or demise resulted from substandard medical or nursing care." Ex. M494. (37) These assertions are inapposite. It is not necessary in order to uphold CMS's findings to determine that the facility could indeed have healed the pressure sore or that the facility somehow caused the bowel perforation or that the resident died or failed because of poor medical or nursing care. Dr. Foster's testimony does not answer the crucial question of whether additional or alternative interventions (as to any of the new or aggravated symptoms that emerged in the final week) were reasonably practicable or needed in order to attempt to reduce suffering or increase quality of life, even if such interventions could not prevent decline and death. (38) Beechwood provided no authority to support the broader concept that, once a resident is expected to die imminently, no other changes in the resident's condition require physician notification. The record includes evidence, which the ALJ could reasonably credit, that this particular resident was able to make decisions about his care and wished aggressive treatment. HCFA Ex. 19, at 3411. Furthermore, it is obvious that a resident's condition may change significantly during the dying process, and that medical and nursing care may affect the quality of death as much as, and as part of, the quality of life. (39) The ALJ could thus reasonably credit the expert testimony offered by CMS that the failure to notify the physician of the major deterioration as it occurred or to clear with the physician the measures that were employed (i.e., oxygen and rectal tube administration) constituted "a serious deviation from accepted standards of care governing nursing." ALJ Decision II, at 11. Neither do we find persuasive Beechwood's reliance on discharge orders of the hospital physicians (when Resident 1 returned from the hospital on February 9th) instructing the facility to "continue current treatment." Ex. M1831-33. Orders issued on February 9th obviously do not respond to events occurring after that date. Beechwood also contended that Dr. Foster testified that "on-going communication between the facility and the physician staff during that week" resulted in PA action taken on February 8, 1999. Beechwood Br. at 55, citing Tr. at 61-63 (April 3, 2001)[actual cite for the relevant testimony of Dr. Foster is at 46-47]. Dr. Foster's actual testimony was far less definitive or clear as to timing: "I think that there is some evidence, whether it be from the medical record or from the daily work log journal that we had kept informally that there was ongoing communication regarding this -- this resident." Tr. at 47 (April 3, 2001). Again, any action or evaluation by the PA on February 8, 1999, would not address whether the physician staff should have been notified of the events of the following week. The PA was also asked if he was kept aware of the resident's changing condition during the week in question and responded: "I can't recall whether they called me on this resident or if they didn't at this point. I can't remember." Tr. at 23 (April 3, 2001). In addition, the PA explained that a work sheet that showed him "addressing" the resident on February 12, 1999, did not mean that he saw the resident on that date, but rather that he then reviewed laboratory test results coming from the hospital following the visit on February 9th. Id. at 23-25. (40) We conclude that substantial evidence in the record viewed as a whole supports the ALJ's conclusion that communications between the nurses and the physician or PA did not take place during the week in question as necessary to provide care of a professional standard to this resident even in a terminal condition. Other arguments that Beechwood presented concerning this resident have been fully addressed elsewhere in this decision (including the unapproved use of oxygen and rectal tubes and various legal contentions).
The ALJ found that prior physician approval was required, and was not obtained by the facility, for administration of Tylenol with codeine on March 24, 1999, and a glycerine suppository on April 4, 1999 (the day of the resident's death). ALJ Decision II, at 13-14. The ALJ found that this constituted prima facie evidence of neglect on those dates. Id. at 14. The ALJ held that evidence offered by Beechwood to show that it took good care of the resident over a number of years, even if accepted as true, did not address whether neglect of the resident's medical needs occurred on the dates alleged. Id. Further, the ALJ rejected the defense that the nurses were following standing orders, holding that:
ALJ Decision II, at 14. Beechwood argued before us that issues relating to orders or approval for care should not be cited as neglect because that charge requires proof that some needed goods or services were denied to this resident. Beechwood Br. at 55, 60. Beechwood contended that the allegations here did not specify what good or service was not provided. Id. at 60. The term "neglect" is defined as "failure to provide goods and services necessary to avoid physical harm, mental anguish, or mental illness" for purposes of these regulations. 42 C.F.R. § 488.301. The allegations credited by the ALJ in regard to this resident on their face do make clear what necessary services were not provided - namely, the services of a physician in determining what medication or other medical treatment to administer. Without a physician having been consulted, it is impossible to know what different or additional treatments might have been ordered for an individual resident in a particular set of circumstances. Beechwood further argued that standing orders allowed the medications to be administered and that orders for each were signed after the fact by the physician on April 12, 1999. Beechwood Br. at 59-60. Beechwood disputed the ALJ's reliance on testimony of Dr. Sower (the Ph.D. nurse on the State Board of Nursing) to support the rejection of "standing orders" absent individualized physician orders, because Dr. Sower described standing orders as a "normal plan of care for a set number of patients" of, for example, a particular hospital physician. Id. at 60, citing HCFA Ex. 13, at 345-46. Dr. Sower went on, however, to make clear that a physician may maintain standing orders on file but must make them "patient-specific," so that "on the patient's chart, he has to have ordered that standing order for this patient." HCFA Ex. 13, at 346-47. Furthermore, the ALJ also cited testimony by Dr. Oskvig that standing orders must be individualized for a patient, placed in the patient's record, and signed by the physician. HCFA Ex. 19, at 3415-16. The record contained orders under which each of the medications was administered but neither order was signed by a physician at the time of the administration. Beechwood argued that the ALJ wrongly stated that the neglect consisted of not obtaining prior approval where the New York standards permit later signatures on telephone orders. Beechwood Br. at 59. The ALJ could properly have concluded on the record before him that a telephone order must be received timely, even though it may be signed later, and that the time frame for signing is 48 hours or less. In the case of the Tylenol with codeine, no notation in the medical record established any physician contact before the order. HCFA Ex. 14, at 408-09. As to the suppository, a purported telephone order was in the resident's record but the surveyor's testimony raised doubt about whether the physician was contacted at all. Id. at 372-75. Thus, the ALJ in resolving the conflicting testimony could reasonably conclude that no prior orders by telephone were in fact received. We conclude that substantial evidence on the record as a whole supports the ALJ's conclusion that this resident's needs were neglected by the failure to obtain physician approval for administering the treatments.
The ALJ described the evidence of neglect of this resident as arising from the staff's failure to notify the physician of vomiting and a fever of 103.4o F on March 30, 1999, and of several subsequent fevers, until April 2, 1999. ALJ Decision II, at 14-15. The resident also experienced chills and cold symptoms. When the resident was seen by the PA on April 2nd, the resident was found to have aspiration pneumonia, and he died two days later. The ALJ rejected Beechwood's position that the physician did not need to be notified sooner under Beechwood's policy because none of the fevers was sustained for more than 24 hours. Id. at 15. The ALJ found persuasive CMS's evidence that the initial very high fever, accompanied by the vomiting and other symptoms, were so alarming as to require notification under good nursing practices, even if the later fevers did not go as high or last more than 24 hours at a time. The ALJ noted that Dr. Foster admitted that the three-day time frame before his PA was notified of the intermittent fevers was "not trivial," and that Beechwood's policy was revamped as a consequence. HCFA Ex. 3, at 2913. The ALJ disagreed with Beechwood's claim that the resident was closely monitored during the intervening days and did not show signs of "significant illness 'other than the intermittent elevated temperatures.'" ALJ Decision II, at 15. In light of the initial serious symptoms, the recurrent fevers demonstrated that the resident was not "by any stretch of the imagination 'recovered'" after March 30th. Id. Before us, Beechwood argued that its presentation had demonstrated that "the care rendered was of high quality . . . and fully compliant . . . ." Beechwood Br. at 60 (citations to prior briefing omitted). (41) Beechwood pointed to testimony by a facility nurse and the PA as showing that the resident was feeling "great" on March 31st. Id. at 61. Beechwood also contended that the ALJ ignored testimony that the PA had "physically" seen the resident on April 1st and had had "conversations" with the nurses about this resident during the period at issue. Id. at 61-62. In addition, Beechwood argued that the March 30th fever spike was "not in and of itself significant without other symptoms" and that the physician would not have ordered any different treatment, had he been called, than that provided by the nurse. Id. at 61. Charlene O'Connor, an LPN, testified that she was feeding the resident when he vomited yellow liquid on her. P. Ex. 12, at 2443-44, 2528-29. He felt warm and was found to have a fever of 103.4o F, but she did not consider this sufficient reason to call Dr. Foster, because -
Id. at 2528-29. She also stated that the next day the resident had no fever, "seemed like his usual self" except for a runny nose, and she concluded he had been coming down with a cold. Id. at 2529. The next day, according to the LPN, the resident did not "even have a runny nose anymore, so he was fine during the day . . . ." Id. The nursing notes paint a rather different picture, however. They show that the resident was running a fever of 102o F in the morning of March 31th, with general discomfort and continuing cold symptoms. Ex. M2341. That night, he ran a fever of 101.7o F, was warm to the touch, and was having chills. Id. He had a fever again the next morning and, by the early afternoon of April 1st, was lethargic with grey color and stayed in bed for the evening with temperature between 100.8 and 101.8o F. Id. The only treatments noted are doses of Tylenol and continued monitoring. By the time the PA was called in on April 2nd to evaluate the resident due to "elevated temps over the past few days," the resident was grey, breathing fast, not eating well, with low oxygen saturation, "legs mottled to the knees" and "cyanotic nailbeds." Ex. M2342. Given the full record, it was not unreasonable for the ALJ to discount the LPN's testimony as either conflicting with the contemporaneous nursing record or demonstrating that she observed the resident only during periods when the Tylenol was holding down his temperature and symptoms temporarily. The testimony on which Beechwood relied to show that the PA actually saw the resident earlier than April 2nd does not support the claim. The LPN testified that she saw the PA on the floor on the afternoon of April 1st, told him that the resident "has been spiking his temp but he doesn't have any other symptoms," and was instructed to "put him down and look at him tomorrow." P. Ex. 12, at 2444. The LPN then put the resident on a list to be seen by the PA the next day. Id. at 2445. This testimony does not establish that the PA was made fully aware of the resident's condition as reflected in the nursing notes and, if anything, confirms that the resident was not seen by the PA until April 2nd. The PA's own testimony before the ALJ described a course of decline for several weeks beforehand, with the resident sleeping more and eating less, followed by what initially seemed to him a flu-like illness. Tr. at 26-28 (April 3, 2001). He testified that the care provided was appropriate:
Id. at 22-29. He contended that he and the physician were "kept abreast" of the resident's condition. Id. at 29. However, on cross-examination, the PA acknowledged that no record existed of his "conversations" with the nurses or of any physician progress notes prior to the April 2nd visit when the chest x-ray was ordered. Id. at 38-39; see Ex. M1885. Finally, Dr. Foster testified that the decision not to call him after the initial fever spike, and recurring "low-grade" fevers, was not necessarily inappropriate where the nurses 'did not perceive him to be seriously ill." P. Ex. 3, at 2590-92. Dr. Foster stated that he would not have prescribed a different initial course of treatment if contacted and noted that the resident was on "comfort care status." Id. at 2592-93. Dr. Foster admitted, contrary to Beechwood's assertions in its briefing before us, that the resident was not in fact seen by the PA for evaluation during the three-day period in question. Id. at 2906. He contended, however, that "observing a patient with a fever who doesn't appear to be in dire straits initially is a reasonable course of action." Id. at 2907. Dr. Oskvig, however, testified, based on his review of the patient's records, that he would expect to be notified as a physician of the temperature and other symptoms that occurred on March 30th. (42) HCFA Ex. 19, at 3377. He further testified that the physician "clearly . . . should have been notified" by the second day of fevers, with chills and warm skin, which Dr. Oskvig described as presenting "what clinically looks like a septic syndrome." Id. at 3378-79. Overall, his opinion of the care provided was that "this patient was put in jeopardy by failing to notify the physician so that a medical evaluation could be made and appropriate therapy instituted for a febrile illness." Id. at 3382. His testimony as a whole indicated that his opinion would apply irrespective of whether the facility had designated the patient as comfort care only. Further, he opined that the systemic condition evidenced by chills, lethargy, mottled leg color and blue nailbeds could have been more likely to be treated effectively had it been addressed earlier. Id. at 3383-84. To the extent the medical testimony about the proper standard of care differed, the ALJ was within his proper role in deciding the weight to give to the conflicting statements. We conclude that substantial evidence on the record as a whole supports the ALJ's conclusion that this resident's needs were neglected by the failure to seek medical attention for him during his illness from March 30 - April 2, 1999.
As to Resident 4, the ALJ found that nursing staff administered oxygen for breathing problems without physician orders. ALJ Decision II, at 16. The ALJ found that CMS's evidence showed that these episodes were significant changes in the resident's condition of which the physician should have been notified. Id. The ALJ further found that, on each occasion, the staff failed to "obtain immediate approval for continued administration of oxygen." Id. The ALJ saw no relevance to Beechwood's assertion that the resident's illness had caused shortness of breath before, since the record did not indicate that prior episodes required oxygen and since the staff apparently considered the episodes at issue to be emergencies, given that that was the justification for not needing a prior physician order. Before us, Beechwood argued that the episodes did not constitute significant changes but rather part of an ongoing, non-acute course. Beechwood Br. at 63. In that context, Beechwood contended that no standard of care required immediate physician notification and approval for continued administration of oxygen, as the ALJ stated. Id. at 63-64. Finally, Beechwood argued that even if there were a violation of a standard of care, that did not constitute neglect since the resident received the oxygen even without earlier notification and approval. Id. at 64. We have already addressed supra the standards for physician notification and approval in the administration of oxygen. We concluded that the ALJ reasonably found that professional standards permit nurses to administer oxygen without a prior order only in an emergency situation, and even then, required the nurse to notify the physician and seek guidance about how to proceed thereafter. Furthermore, Beechwood did not deny that its own policy called for obtaining a physician order within 24 hours of emergency administration of oxygen by nurses. HCFA Ex. 7, at 13. Beechwood asserted that the attending physician testified that she would not have expected to be notified immediately of the oxygen use since the resident's saturation levels rebounded. Beechwood Br. at 63. The actual testimony reflects that the physician thought that the events constituted significant changes in condition and that she would expect the staff to notify her if they were using oxygen, but that given the improvement the notification was not as urgent. P. Ex. 4, at 2195-96. This testimony does not demonstrate that Beechwood was in substantial compliance with the cited requirement in relation to this resident. It is, on the contrary, consistent with Dr. Oskvig's testimony that a physician should have been notified of the first episode. HCFA Ex. 19, at 3369-70. He also noted that the 'stat' orders for medication and tests issued by the attending physician when she was notified the day after the second episode suggest that the resident's condition was viewed as potentially life-threatening at that point. Id. at 3370. Beechwood's reliance on notations in the SOD about the resident's continued leg edema, lethargy, poor intake of food and fluids, and need for assistance with ADLs to show that the medical events were chronic rather than acute is misplaced. Beechwood Br. at 63. The attending physician's testimony cited above demonstrates that the drops in saturation level on March 5 and 7, 1999 were significant in themselves. CMS's references to the continued decline in the resident's health over the following week, culminating in the physician ordering her to the hospital on March 17th where she was newly diagnosed with thrombosis and embolism, relate to an additional basis for the neglect charge. HCFA Ex. 7, at 13-14. Dr. Oskvig testified that his record review showed no indication that staff advised the attending physician of the resident's worsening condition that week. HCFA Ex. 19, at 3371. He described the symptoms as presenting "the potential for a life-threatening medical condition being responsible for the hypoxia" which "should have resulted in regular and frequent updates of the attending [physician] of record." Id. at 3371-72. We conclude that the ALJ's findings in regard to this resident were supported by substantial evidence in the record as a whole.
The ALJ found that Resident 6 entered the facility on March 25, 1999, with multiple diagnoses but an "essentially normal" initial physical examination and that he was seen by his physician on April 7 and 10, 1999. ALJ Decision II, at 17 (record citations omitted). The last time he was seen, he was sent to the hospital and died soon after. Id. The ALJ found that Beechwood did not overcome evidence that the resident "deteriorated markedly" after admission, developing labored breathing, a dusky color, and blue lips and nailbeds. Id. From March 27th to April 3rd, he removed or refused his oxygen tube repeatedly. Yet, Beechwood staff did not notify the physician of these developments until April 7th. Id. at 18. On April 9th, the resident developed a sore throat and dysphagia, which worsened overnight. Again, there was no evidence that the physician was contacted between April 7th and April 10th. Id. The ALJ rejected Beechwood's contention that the lack of notification was harmless because the physician or his PAs physically saw the resident as they made daily rounds and had access to his medical record. Id. The ALJ concluded that, even if that were true, the nursing staff was still obligated, under accepted standards of practice, to bring to the physician's attention the resident's condition as they observed it throughout the day and night. Id. In addition, the ALJ found the factual underpinning of Beechwood's assertion unsubstantiated because the cited testimony of the clinical services director was only that the physician or PA "would have seen the resident if they visited the resident's floor to evaluate someone else." Id., citing P. Ex. 2, at 3319. On appeal, Beechwood argued that the ALJ misinterpreted the medical history because he treated the unremarkable initial physical examination as setting a standard against which the later developments were characterized as deterioration, whereas the results of that physical examination should have been understood as "baseline" for the multiple diagnoses that included "pre-existing severe lung disease." Beechwood Br. at 65-66. In that context, Beechwood argued that the resident's symptoms did not change until he developed the sore throat and pain swallowing on April 7th. Id. at 66. The surveyor testified that the physical was "essentially" normal (except for scattered rhonchi heard in his lungs consistent with his lung diagnoses). HCFA Ex. 12, at 44-45. Beechwood cited no basis in the record for its claim that the multiple diagnoses necessarily implied that all of the symptoms recorded in the nursing notes over the succeeding days had also been observed but not recorded during the initial physical examination. Beechwood also argued that the physician or PA did see the resident daily because the resident was moved near the nursing station (because of his repeated falls (43)) and the PA or physician frequented that area. In any case, Beechwood argued, the "real issue" was that the physician was "adequately aware" of the resident's condition. Id. at 67. Further, Beechwood stated that the physician testified that medical attention was not warranted during the period at issue because "the resident had COPD [cardio-pulmonary disease], end stage," and the development of low oxygen saturation, dusky color, edema, and falls were all "to be expected given his condition and noncompliance." Id. Beechwood quoted selectively from the SOD in an attempt to show that the concern was only whether the physician knew all he needed to prescribe Haldol when he saw the resident on April 7th. Beechwood Br. at 66. Hence, Beechwood claimed that the surveyor had not expressed concern about a lack of notification about any deterioration, which the ALJ allegedly arrived at on his own. Id. Contrary to Beechwood's portrayal, however, the SOD does reflect concern about the absence of notification of the resident's developing symptoms, both before and after April 7th, as well as about the lack of a physical examination on April 7th. HCFA Ex. 7, at 11. A reading of the SOD suffices to debunk Beechwood's claim, since it states specifically that there was "no evidence that physician was made aware of the resident's need for oxygen, change of color, shortness of breath on exertion, falls or leg edema" and that "no physical exam was recorded." HCFA Ex. 7, at 11. Dr. Foster testified that his observation of the resident on April 7th was not a "careful physical examination" but rather took place from seven-eight feet away. P. Ex. 3, at 2600. The nurses asked him to consider medication to manage behavioral problems. Dr. Foster sat at the nursing station for 20 minutes, saw the resident behave belligerently with his wife and some aides, and concluded that "globally" he was "robust and strong and well on that occasion." (44) Id. at 2601. Dr. Foster acknowledged that he could not answer for "specifics about subtleties between his condition on that date and on admission and that he did not remember if he was advised by the nursing staff about the low oxygen, the dusky color, the falls, or the edema. Id. at 2601-02. We conclude that substantial evidence in the record as a whole supports the ALJ's conclusion that the treatment of this resident fell below accepted nursing standards and constituted neglect evidencing violation of the requirement at issue.
In addition to the general arguments about scope and severity which we have rejected and do not address again, Beechwood argued that no deficiency could be cited under this tag without specific findings of inadequate supervision. The regulation at issue, discussed in more detail supra, requires a facility to "ensure" that each "resident receives adequate supervision and assistance devices to prevent accidents." 42 C.F.R. § 483.25(h)(2). Beechwood contended that the "adequacy of care planning and documentation process, although leading to determinations of what needs to be done for the resident, and thus potentially a cause for inadequate supervision, should not be cited as deficient under this regulation." Beechwood Br. at 68. While the ALJ did find that Beechwood failed to document the residents' risk for falls and plan adequately for prevention, he also found that Beechwood failed to "investigate adequately the care that residents received which may have resulted in the residents sustaining falls; or, monitor adequately the residents to assure that they did not fall." ALJ Decision II, at 20. It is clear that the ALJ's findings thus went beyond the inadequacy of the evaluation of and planning for the residents' needs to address the inadequacy of the actual supervision and assistance devices provided to them. Further, Beechwood challenged the ALJ's collective evaluation of "individual facts or episodes from within individual findings" as a "crude attempt to sustain the deficiency." Beechwood Br. at 68. Beechwood contended that aggregation was properly done only by the surveyors and only in setting the scope and severity level once each incident alone proved a violation. Id. At the ALJ level, Beechwood argued, a determination must be made independently that each "finding presented in the SOD" represented prima facie a violation of the regulation as cited, and then a decision reached as to "whether each finding is supported by the preponderance of evidence presented by both parties." Id. Any other methodology is a clear error of law, according to Beechwood. Id. We disagree with this outline of the analytical process required. The ALJ must indeed evaluate the basis asserted by CMS for the alleged deficiency finding, but we find no authority for Beechwood's claim that every individual incident or finding cited must independently demonstrate a violation or that it is per se erroneous to consider a pattern of incidents collectively as the basis of a deficiency finding. It is not always essential for the ALJ to find that every allegation as to every resident was proven or that each allegation individually sufficed to show noncompliance, in order for the ALJ to conclude that the facility failed to show by the preponderance of the evidence that it was in substantial compliance with the cited regulation. We turn now to Beechwood's challenges to the ALJ's specific findings under this tag.
The ALJ found it undisputed that this elderly resident was admitted post-fracture of her left hip and, after an incident (the nature of which was disputed), she had sustained a new hip fracture. ALJ Decision II, at 20. CMS presented evidence that the resident fell in the facility, resulting in the re-injury requiring hospitalization and new hip replacement surgery. Id. Beechwood contended that the resident "did not fall, but, rather, that the resident's legs gave out during a transfer resulting in the staff lowering the resident to the floor." Id. at 21. The ALJ concluded that under either scenario the resident experienced an accident in the ordinary sense of the word. Id. Even though the incident occurred in the presence of staff, the ALJ found that the facility did not react to or investigate it until after the resident reported it to her orthopedist the next day, and did nothing to prevent recurrence or alter the care plan prior to that point. Id. Before us, Beechwood argued as a matter of law that the "characterization" of this incident did matter because adverse outcomes "associated as a direct consequence of care" are excluded from the definition of accidents. Beechwood Br. at 69. According to Beechwood, the exclusion should apply here because the incident involved an adverse event occurring while the aides were providing care. Id. The SOM explains that an "accident" is "an unexpected, unintended event that can cause a resident bodily injury and does not "include adverse outcomes associated as a direct consequence of treatment or care (e.g., drug side effects or reactions)." SOM Appendix PP, Guidance to Surveyors, Part 2, SOP 483.25 Quality of Care (Rev. 274, June 1995). The Board has considered the scope of the exclusion before in Woodstock. The language of the exclusion is limited to direct consequences of providing a treatment properly but nevertheless incurring some adverse effects, as evidenced by the example of drug side effects. We do not read it to extend to the consequences of providing care improperly, even though the error is made in some sense in the course of care delivery. In the incident at issue, the resident's legs buckled under her. The disagreement is over whether she fell to the floor or was lowered to it by the aides. The collapse itself was clearly an unanticipated accidental occurrence and not a side effect of a course of treatment. That an accident occurred does not itself establish a violation. however, since the real issue about the event is whether it demonstrates that the facility did not provide adequate supervision and assistance devices to prevent reasonably foreseeable accidents. In this regard, it is the facility's response to the incident, as much as the event itself, which the ALJ faulted. Beechwood argued that the ALJ ignored the facility's reassessment of and new planning for the resident's risk for falls. Beechwood Br. at 69-70. Beechwood misconstrued the ALJ's reasoning. He clearly recognized that Beechwood presented evidence that the resident's fall risk assessment was changed to require use of a Hoyer lift, but pointed out that this step was taken only after the resident returned from her doctor's visit during which she reported the fall. ALJ Decision at 21. The ALJ concluded that the facility staff knew of the accident but did not act to prevent a recurrence until after the resident herself reported it to the orthopedist. Id. It was not unreasonable for the ALJ to infer that this inaction evidenced a failure to take practicable measures to prevent further accidents, such as the use of the Hoyer lift assistance device, during the intervening period. Beechwood suggested, however, that no action could be expected from the facility because the aides involved did not "perceive this incident as an accident or as having caused any harm to the resident, and thus did not report it to the nurses." Beechwood Br. at 69. We do not find this argument persuasive. It was not necessary for the aides to perceive an accident, or recognize the serious injury done, for them to be expected to report an incident in which the method used for providing assistance to the resident was unable to prevent her from ending up on the floor. We conclude that the ALJ's findings as to this resident are supported by substantial evidence in the record as a whole.
The ALJ found it undisputed that, in addition to the issues discussed about this resident above under Tag F224, he had dementia, an abnormal gait and experienced frequent falls, eight just between March 30, 1999 and April 7, 1999. ALJ Decision II, at 21. CMS presented evidence that the staff tried to deal with the falls by telling the resident not to try to walk or transfer without assistance but such approaches were "ineffective care" because documentation showed that the resident could not follow directions or appreciate risks due to dementia. Id. at 21-22, and record citations therein. CMS also presented evidence that Beechwood did not reassess or revise its care plan in the face of the numerous falls. Id. at 22. The ALJ accepted as true Beechwood's assertions that it attempted interventions such as using a buddy cushion, a bed alarm, low bed or lounge chair, and conceded that it was possible that nothing more could have actually prevented the falls. Id. Nevertheless, the ALJ concluded that Beechwood could not properly make that assumption when it had not done a comprehensive assessment of the resident's needs or developed a plan of how to proceed when the resident failed to respond to the care that was given and continued to fall. Id. Before us, Beechwood asserted that the resident's cognitive impairments were actually understated by the ALJ, and that, given his high fall risk, it was necessary to balance his safety issues with his need for activities and the potential negative effect of restraints on his mental status. Beechwood Br. at 70. Beechwood argued that the interventions which it took were appropriate, that verbal reminders were only one aspect, and that nothing else could be done "short of restraints." Id. at 70-71. Beechwood also contended that no regulation required that every specific intervention tried be recorded in the care plan and that the initial care plan prepared on March 26th was not required to be finalized until April 14, 1999, based on the resident's admission date. Id. at 71. Further, Beechwood asserted that its minimum data set (MDS) assessments and resident assessment protocols (RAPs) were completed on April 7th. Id. Beechwood noted that it was not found out of compliance with the regulations on comprehensive assessments at 42 C.F.R. § 483.20(b). Further, Beechwood contended that the interventions actually undertaken were the "best evidence" of its assessment and care planning for this resident. Id. at 72. The ALJ could reasonably conclude that the evidence, as summarized below, did not support Beechwood's claims of substantial compliance with this requirement as to Resident 6. The SOD noted that two of the falls (on March 30th and April 7th) occurred while the side rails on the resident's bed were up and that the record documented other attempts to climb over or scoot around the end of the side rails. HCFA Ex. 7, at 21. Incident reports either did not report preventive measures to be taken in the appropriate space or reported orienting or reminding the resident not to walk or transfer alone. Id. The SOD also noted documentation of "frequent room monitoring, at least one time the use of an alarm, and also moving the resident out to the nurses' station for observation," and reported the following:
Id. at 22. The surveyor also testified that some preventive measures, such as use of a lap buddy, were apparently tried "episodically" but not included in instructions on how staff was to care for the resident. HCFA Ex. 12, at 78. Dr. Oskvig testified for CMS that a "confused individual with cognitive deficit" is not "going to be able to remember instructions in order to maintain their safety." HCFA Ex. 19, at 3405. He described what should be done to prevent falls in such cases:
Id. at 3405-06. The testimony presented by Beechwood mentioned a number of interventions that were tried, but did not contradict the evidence about the episodic, unsystematic nature of these efforts. P. Ex. 12, at 2454. The LPN thus testified that his bed was moved to the nurses' station at night "on four or five different occasions," that a low bed was tried "for several days" but it was "very difficult for the staff" because of his weight, and that a buddy cushion was tried "but he just took it off all the time." Id. The electronic care plan produced by Beechwood (showing entry date of March 26, 1999 and last edit date of April 2, 1999) lists general nursing approaches to his dementia problems, including falls. Ex. M1789. The eight entries mostly involve orienting, encouraging and assisting him in self care. Id. The only two approaches apparently relating to fall prevention are "[i]nstitute proper safety measures" and "[b]ed alarm at hs [at bedtime] and prn [as needed]." Id. This document is consistent with the allegations that no systematic effort was made to institute consistent measures to prevent his "numerous falls since admission" (id.) from recurring, to evaluate why the steps taken were not successful, to develop prevention strategies, or to consider whether other measures could be adopted, including whether to use restraints where necessary for safety. Dr. Foster testified at the State hearing that he was satisfied to leave the specifics to the nursing staff, but did not explain why the facility itself did not need to adopt specific measures. P. Ex. 3, at 2608. Dr. Foster also testified that he would not think this resident to be a "good candidate for restraints," because of his agitation and possible worsening of his mental status. Id. at 2609-10. Dr. Foster did not indicate that the options for use of any forms of restraints was evaluated at the time. Id. The regulations do indeed strongly discourage use of restraints where they are "imposed for purposes of discipline or convenience, and not required to treat . . . medical symptoms." 42 C.F.R. § 483.13(a). The corollary, however, is that some medical symptoms do require the use of some forms of restraint. Unquestionably, the numerous falls represented a serious medical problem. In fact, the facility did use some restraints in dealing with this resident, including side rails (which may themselves have increased the risk of injury from falls since the resident had a history of climbing over them) and the occasional use of a lap buddy. We are not persuaded that the facility was unable to try anything practicable to reduce the fall risk "short of restraints," or that no use of restraints was justifiable for the resident's medical and mental condition. In any case, there is no basis to conclude that the facility in fact evaluated and rejected all the options. The relevant concern here is not the failure to put each specific approach in the care plan, as Beechwood seemed to think. The concern is that the record reflects no evidence that the resident was consistently provided with supervision or assistance in other forms to protect him against the obvious and acknowledged high risk of constant falling. A systematic strategy and re-evaluation of options after repeated falls, if documented in assessments and/or care planning, would have been some evidence of this. Other evidence might have been presented from nursing records or staff testimony. What evidence was presented, as we discussed above, is consistent with the conclusion that any interventions, however varied they may have been, were anything but systematic. We conclude that substantial evidence in the record as a whole supports the ALJ's findings as to this resident.
The ALJ found it undisputed that the resident was admitted for rehabilitation from a hip fracture repair after a fall and then sustained two falls at the facility over the next two weeks in December 1998. ALJ Decision at 22. Despite an x-ray showing an unstable fracture on January 26, 1999 and physician's orders to avoid weight bearing for six weeks, the resident continued to attempt to walk. Id. She fell again on March 13th and 21st and sustained a new fracture of the other hip. Id. at 23. CMS offered evidence that the staff did not reassess the risks, choose appropriate preventive measures, or modify the care plan in light of the frequent falls. Id., and record citations therein. The ALJ rejected as inapposite Beechwood's response that it performed a comprehensive initial assessment and plan and that it undertook various measures to protect against falls. Id. The ALJ found it unrebutted that Beechwood did not take measures to reassess the risks and revisit the care plan to address the reasons for the falls between December 1998 and March 1999, and in particular to account adequately for the resident's dementia and inability to comply with directions. Id. Before us, Beechwood argued that the evidence relied on by the ALJ did not go to lack of supervision but only to alleged inadequacies in assessments, care planning and documentation. Beechwood Br. at 73. Thus, Beechwood again argued that it was not charged under 42 C.F.R. § 483.20(b), that it was in compliance, and that it had no opportunity to submit evidence "on its comprehensive care planning and assessments." Beechwood Br. at 75. We have already addressed Beechwood's general argument that the ALJ could sustain a deficiency only if he made scope and severity findings identical to CMS's. In this part of its argument, however, Beechwood elaborated on this thinking to develop a point that the ALJ "arbitrarily and capriciously expanded on what the surveyors wrote in the SOD." Beechwood Br. at 74. The same language was used many other times in Beechwood's briefing, but we discuss it here because Beechwood provided its most articulate support for it here. Thus, Beechwood argued that the ALJ credited surveyor testimony that mistook facts relating to Resident 5 for those relating to Resident 7, instead of citing the SOD. Beechwood also argued that CMS failed to show what else the facility might have done for the resident and asserted that the "care plan and adjustments made after Res[ident] #7's December falls were working" because she did not fall for two months. Beechwood Br. at 75. The resident's orthopedist allowed her to begin bearing weight after March 11, 1999, which was necessary for rehabilitation but predictably increased her fall risk, according to Beechwood. Id. Thus, Beechwood asserted that "[w]hat the facility could do for Res[ident] #7 to keep her safe when the staff was not supervising her walking could not be adjusted further," so that the increased "risk of falling was accepted by those responsible for her care plan as an appropriate trade-off for the need to do weight-bearing rehabilitation." Id. Beechwood did not explain, however, why the need for Resident 7 to begin weight-bearing activities necessarily implied not supervising those activities. The responsibility for identifying alternative measures to protect the resident from the predictably increased risk of additional falls lay with Beechwood and its staff, not with the surveyors or CMS. Beechwood has not shown that it exhausted the possible measures to provide supervision and employ devices that might minimize the risk or damage of falling. Nor did Beechwood demonstrate, such as by progress notes or care plan documentation, that the resident's caretakers actually did make a conscious trade-off of increasing the risk of yet another fall and fracture for the benefit of unsupervised and unassisted weight-bearing activities. We conclude that the ALJ's findings concerning Resident 7 are supported by substantial evidence on the record as a whole.
The deficiency finding under this tag is essentially derivative of the other findings. CMS asserted that these deficiencies evidence a failure to comply with the requirement that the facility be administered effectively and efficiently in order to maximize the well-being of each resident. ALJ Decision II, at 25, citing 42 C.F.R. § 483.75. The ALJ concluded that the "substantial noncompliance" which Beechwood failed to rebut under Tags F224 and F324 demonstrated that the facility was not so administered as to meet this requirement. Id. at 26. He concluded that his finding that Beechwood was not deficient under two tags alleged by CMS did not undercut the evidence of poor administration. Id. Specifically, he concluded that the picture that emerged from his findings of noncompliance was -
Id. Before us, Beechwood argued that, since this deficiency was "completely bootstrapped" to the findings under Tags F224 and F324, its exceptions to those findings should undercut this one as well. Beechwood Br. at 76. Since we have rejected those exceptions in our analysis above, they obviously do not undercut the findings on Tag F490 either. Beechwood offered two additional arguments. First, it asserted that the ALJ erred by finding a deficiency based on the "preamble sentence in 483.75" where he did not find a violation of any of the "actual numbered and lettered subparts of the regulation which follow." Id. (45) Second, Beechwood called the ALJ's conclusion "nonsensical" for assuming that any facility "with deficiencies in two tags directly related to care" must of necessity "also be so ineffectively and inefficiently run as to merit an additional deficiency" for poor administration. Id. According to Beechwood, such an assumption would be "patent error, as it would result in a hefty percentage of all facilities in the county being classified" as poorly administered. In support, Beechwood cited a CMS-sponsored study as showing a decrease in deficiencies per facility from 7.9 in 1993 to 5.7 in 1999, demonstrating that Beechwood had fewer deficiencies cited in April 1999 than the national average. Id. The specific language of the regulation at issue is as follows:
42 C.F.R. § 483.75. There follow approximately eight columns of detailed administration requirements, from having a State licence, to proper staffing and training, to quality assessment committees. Beechwood cited no authority, and we find no support, for the idea that the mandatory language quoted somehow has no effect because it is not contained in a numbered or lettered subpart. Beechwood's second argument mischaracterizes the rationale for the ALJ's conclusion. The ALJ nowhere reached a broad conclusion that any two deficiencies relating to care of residents automatically justify an additional deficiency under the administration rubric. Rather, the ALJ clearly discussed how the precise factual findings under these tags, in the context of the totality of the evidence, painted a picture of a poorly-run facility failing to be attentive to residents' needs. We see no relevance to whether the number of deficiencies found in this particular survey was less than the national average per facility in that year, especially given the numerous deficiency findings made over the succeeding two months. Nor does the quality of administration in other facilities bear any relation to determining whether Beechwood met the regulatory requirements. We conclude that the ALJ's findings as to this tag are supported by substantial evidence in the record as a whole. Conclusion For the reasons explained in detail above, we conclude that the FFCLs in ALJ Decisions I and II should be sustained except as to the two specific examples regarding individual residents which are discussed in the text of this decision. Since our reversal of the ALJ's findings regarding those two allegations does not affect the outcome of our evaluation of the deficiency findings to which the allegations were directed, we decline Beechwood's request that we overrule the findings and conclusions of the ALJ sustaining deficiencies found in the April, May or June surveys. We further decline Beechwood's request that we remand to the ALJ to consider additional deficiency findings from the May and June survey which he did not address. In the context of this case and the findings which we have sustained, any outcome of any further review of findings not already evaluated could not alter the clear evidence of noncompliance of a kind more than adequate to support the imposition of the appealed remedies. We conclude finally that the ALJ did not err in concluding that CMS had the authority to impose the remedies appealed by Beechwood. Appendix Brook Chambery and James E. Healy, Esq. Re: Beechwood Restorative Care Center
Mr. Chambery and Mr. Healy: Beechwood Restorative Care Center (Beechwood) requested review of the decision by Administrative Law Judge (ALJ) Steven T. Kessel, on remand from this Board's decision in Beechwood Sanitarium, DAB No. 1824 (2002). Beechwood Sanitarium, DAB CR966 (2002). The Board's decision directed the ALJ, among other things, to issue a subpoena duces tecum compelling the Centers for Medicare & Medicaid Services (CMS, formerly HCFA) to produce certain documents. The Board found that CMS had failed to produce these documents to Beechwood over a lengthy period, in spite of Freedom of Information Act (FOIA) requests and an ALJ order to produce documents. In its request for review, Beechwood asserted that the subpoena duces tecum issued by the ALJ on remand was narrower than the subpoena contemplated in the Board's remand decision and that the CMS response to the subpoena was even more restrictive. As discussed below, the ALJ issued the subpoena "pursuant to the instructions" in the Board's remand decision, using wording from part of Beechwood's February 16, 2001 subpoena request, which the Board had identified as specifying the documents Beechwood was seeking. The CMS response to the subpoena interpreted the wording in the subpoena narrowly, in a way we conclude is inconsistent with the context in which the wording was used and with the Board's decision. To ensure the integrity of the appeals process and to avoid any further remands of this case, we are directing CMS to produce information and documents as part of the current proceeding, as outlined below. Beechwood's assertion The subpoena issued on remand ordered production only of "all of the notes and workpapers by the federal surveyors, including but not limited to Michael Daniel and Susan Kelly." According to Beechwood, the "relevant files on Beechwood should have included certification material received in hard copy or electronically from the State survey agency (such as the required CMS Forms 1539), as well other decisionmaking notes regarding CMS' concurrence and remedies chosen." Request for Review of CR966, at 3. Beechwood asserted that, contrary to what he said in his decision, the ALJ "cannot possibly be certain that the very few documents actually produced by CMS in response to the subpoena ‘were those of people employed by CMS's Regional Office at the time of the surveys.'" Id., quoting CR966 and CR821, at 4. Beechwood pointed out that, in response to the subpoena, CMS Associate Regional Administrator Sue Kelly declared: "No federal surveyor participated in any of the three surveys . . . Therefore, there are no ‘notes or work papers by the federal surveyors involved with the termination of Beechwood . . . ." Kelly Decl. at ¶ 5. Beechwood argued that, by arbitrarily limiting the subpoena, the "ALJ continued to prejudice Beechwood's ability to present its case." Request for Review of CR966, at 3. Beechwood said that, should a remand be required following disposition of the other issues on this appeal, then such a remand should include directives for the issuance of, and CMS's compliance with, the broader scope subpoena. Id. at 4. CMS's arguments In response, CMS asserted that the "ALJ's subpoena conformed precisely to the Petitioner's request." CMS Response II, at 9. To support this assertion, CMS asserted the following: • The original request for documents was for "all surveyor notes and work papers relating to the termination of Beechwood, a set of documents Petitioner at the time described with the term ‘certification file.'" Id., citing DAB No. 1824, at 4. "Contrary to the DAB's finding, and as was made very plain to Petitioner in 2001 at the time of its original complaint, all documents responsive to [the ALJ's] November 20, 2000 Order had been provided to Beechwood." Id., citing CR 966, at 4; CMS Letter to Beechwood dated February 5, 2001; CMS's Brief in Opposition dated February 1, 2002, at 15.
Analysis The threshold question is what was necessary in order to comply with the Board's remand order, specifically, whether that order limited the scope of the subpoena duces tecum the ALJ was obligated to issue (and therefore documents CMS was obligated to produce) to "federal surveyor notes and work papers," as interpreted in the CMS response. First, we note that the Board's prior decision nowhere uses the phrase "federal surveyor notes and work papers" to describe the scope of the subpoena to be issued on remand. Instead, the Board's instructions to the ALJ on page 19 of the decision stated: "The ALJ shall issue a subpoena either to compel CMS' compliance with his November 20, 2000 Amended Order or to satisfy the request for a subpoena duces tecum sought by Beechwood on February 16, 2000." DAB No. 1824, at 23. The ALJ said that he was issuing his subpoena on remand in accordance with those instructions, but did not specify whether he was ordering compliance with his amended order or with the February 16 request. Upon close examination, this makes a difference since, as we explain next, the amended order could be interpreted as ordering CMS to produce only a subset of the documents encompassed in the February 16 request. The ALJ's amended order was in response to a November 10, 2000 request for a subpoena duces tecum for a set of documents Beechwood said it had previously denominated as the "certification file." A footnote to the term "certification file" referred back to Beechwood's letter of October 13, 2000, quoting the following from that letter:
Beechwood's November 10, 2000 Request, n.1. Thus, the reference to "certification file" was not originally a reference to "federal surveyor notes and work papers" (although such documents could be considered "supporting documentation" included in a "certification file" as described by Beechwood). Moreover, in renewing its subpoena request, Beechwood relied on the statement in the Eighth Circuit's decision in Beverly California Corporation v. Shalala, 78 F.3d 403 (1996). In that case, the court had agreed that "HCFA should have preserved all of the work papers related to the survey and that the [nursing home] should have had the opportunity to use the work papers in its defense" since "the working papers might have shed light on those instances in which the surviving survey documents directly conflict with each other . . . ." 78 F.3d at 409. Beechwood compared its situation, asserting:
Beechwood's November 10, 2000 Request at 2 (emphasis added). The ALJ's amended order indicates that he understood that the request was broader than State surveyors' notes and work papers. The first page of the November 20, 2000 amended order contains the following statement: Petitioner has titled these documents "certification file" for Beechwood, which contained the working papers, notes and other documents of the surveyors and HCFA and upon which HCFA may have relied to base its determination. (Emphasis added.) The amended order goes on to state:
November 20, 2000 Amendment to Order and Notice of Hearing at 1. The ALJ directed amendment of his Orders dated October 5, 2000 and November 1, 2000 to "provide that HCFA as part of its February 5, 2001 prehearing exchange submission should include all surveyor notes and workpapers . . . ." Id. at 1-2. The amended order concluded:
Id. at 2. The amended order is unclear since, unless the phrase "these documents" refers back to all of the documents requested, a subpoena would still have been necessary. Yet, the immediate antecedent of the phrase "these documents" is "all surveyor notes and workpapers." Of course, the logical way to resolve this apparent inconsistency is to interpret the term "surveyor" to include CMS staff involved in the survey who might testify as witnesses and to interpret "notes and work papers" to encompass the other documents requested. An alternative would have been for CMS to ask the ALJ to clarify the amended order, which it did not do. Instead, the CMS February 5, 2001 response to the ALJ's amended order essentially was that the State had produced the State surveyors' notes and work papers in the State proceeding and therefore CMS saw no need to produce them again. Thus, contrary to what CMS asserted here, the Board did have a basis for concluding that CMS had not produced any documents in response to the amended order. Moreover, the CMS response did not identify specifically what had been produced by the State, nor provide any assurance that there were no additional State surveyor notes or work papers in the CMS files. An additional problem with the CMS response was that the ALJ's order did not limit the term "surveyor" the way that CMS chose to interpret it, as meaning only State personnel who actually conducted the surveys. Finally, the CMS response did not address either the rationale stated for the amended order – that Beechwood was entitled to any documents constituting prior statements of a CMS witness - or the concern expressed by the Eighth Circuit – that documents that might aid a nursing home's presentation of its case be produced. Beechwood's February 16, 2001 renewed request after receiving the CMS response did make clear that Beechwood thought the response was inadequate, particularly in the face of the CMS continued failure to respond to Beechwood's requests under the Freedom of Information Act (FOIA) for a broader set of documents. The renewed request states both that Beechwood is requesting a subpoena for "notes and work papers prepared by federal surveyors involved with the termination of Beechwood, including but not limited to Michael Daniel and Susan Kelly" and that Beechwood renewed its subpoena request of November 10, 2000 (which, as explained above, incorporated by reference the October 13, 2000 description of "certification file"). February 16, 2001 Request for Subpoenas at 1-2. Beechwood also requested the ALJ to subpoena Mr. Daniel and Ms. Kelly as witnesses, explaining that they were "involved in both the survey and decision making process related to Beechwood's termination." Id. Thus, in this request, while Beechwood used the term "federal surveyor," the term clearly was not limited to individuals actually conducting the surveys. In its first request for Board review, Beechwood did, as CMS pointed out, initially seem to frame a more narrow request, by stating that CMS had not produced any notes or work papers of any federal surveyors and by using the term "certification file" in a parenthetical after a reference to notes and work papers. The Board decision adopted some of this wording, referring to "the surveyor notes and work papers (the certification file)" in describing the ALJ's amended order of November 20, 2000 and referring to "the certification file or any other notes or work papers prepared by any federal surveyor" in describing the February 16, 2001 request. While this wording is unfortunate, we do not think it ultimately should have been misleading since Beechwood's arguments relied on its earlier production requests.* Overall, the Board's decision indicates that it understood that both Beechwood's requests for subpoenas and the ALJ's amended order were for a broader set of documents than what CMS had produced. Indeed, in concluding that Beechwood had identified the documents it was seeking with sufficient specificity, the Board decision referred back to Beechwood's requests of October 13 and November 10, 2000, and February 16, 2001. As noted above, the Board's decision gave some discretion to the ALJ to frame a subpoena duces tecum on remand as either requiring compliance with the ALJ's amended order of November 20, 2000 or as requiring production consistent with Beechwood's February 16, 2001 request. The subpoena issued on remand ordered CMS to produce "all of the notes and work papers by the federal surveyors involved with the termination of Beechwood, including but not limited to Michael Daniel and Susan Kelly." The cover letter indicated that the ALJ was issuing a subpoena pursuant to the Board's instructions on remand. The ALJ did not specifically refer to either the November 20, 2000 amended order or the February 16, 2001 renewed request for a subpoena. This makes sense only if the two were in fact coextensive – in other words, the scope of the amended order was intended to be the same as the February 16, 2001 request. Moreover, the reference to Mr. Daniel and Ms. Kelly is from the February 16 request and means that the term "federal surveyor" was being used in the sense Beechwood had been using it – to refer to CMS staff who were involved with the Beechwood surveys and termination. In spite of this context and wording, the Kelly Declaration that CMS submitted with its response to the subpoena took the position that "[n]o federal surveyor participated in any of the three surveys of Beechwood Sanitarium" and therefore there are no documents responsive to the subpoena. The Kelly Declaration nonetheless acknowledges that Michael Daniel (identified as a "Nurse Surveyor, CMS Region II") accompanied the State surveyors on their April 15, 1999 visit to Beechwood to provide oversight (and generally has survey oversight responsibilities) and identifies Linda Tardiff as "formerly a Nurse Surveyor in CMS Region II, [who] reviewed the April 22, 1999 Statement of Deficiencies." Id. at ¶¶ 4, 5, and 6. The Kelly Declaration indicates that CMS was producing notes made by these two individuals, but takes the position that these notes are "not within the ambit of the Subpoena." Id. at ¶ 7. The Kelly Declaration also makes clear that what CMS produced on remand was limited to "notes and work papers" and that CMS was interpreting "notes and work papers" as narrowly as possible. Moreover, in spite of the specific reference to Ms. Kelly in the ALJ's subpoena, her declaration does not address whether any prior statements by her were in the CMS files. Contrary to what CMS suggested here, this response does not give the impression of an attempt by CMS to meet Beechwood's concerns. First, the ALJ's subpoena on remand at the very least made clear that he was using the term "federal surveyor" to include both Mr. Daniel and Ms. Kelly although he would have been aware that their role was in providing oversight of and reviewing the State surveys, rather than actually conducting them. Moreover, since the Board's decision had used "notes and work papers" alternatively with "certification file" as shorthand for the broader set of documents sought by Beechwood, and the ALJ did not specifically state he was limiting the scope of the subpoena to only part of the documents that CMS could have been ordered to produce pursuant to our decision, CMS should have either interpreted the phrase "notes and work papers" more broadly or have sought clarification of the subpoena. Even if the CMS response could be considered consistent with the wording of the subpoena on remand (which it cannot), it certainly does not meet the spirit of the remand decision, nor show any comprehension of the rationale underlying the ALJ's amended order and the Eighth Circuit's statement. CMS argued that we should ignore Beechwood's argument here since Beechwood did not before the ALJ object to the wording of the subpoena or complain about the CMS response. Beechwood's brief on remand, however, indicates that Beechwood thought at the time that what CMS had produced was the "entire quantum of materials generated and maintained by CMS with respect to these allegations against Beechwood" and that CMS did not produce "one scrap of paper formally reviewing, certifying, approving, or concurring with the DOH-drafted SODs for Beechwood" because those documents did not exist. Beechwood's Brief on Remand at 8 and 10. Indeed, Beechwood alleged that the "total lack of a proper paperwork trail, as mandated by CMS's State Operations Manual Sections 2700, 2762, 2777, 2778, 3024, and 3026" casts doubt on the validity of the deficiency findings. Id. at 10, n. 5. Apparently, Beechwood realized only later that the Kelly Declaration was not saying that such documents did not exist, but only that they did not fit within CMS's very narrow interpretation of what it had to produce. In any event, even if it would have been preferable had Beechwood objected sooner, Beechwood's failure to do so does not excuse CMS's actions. Neither the CMS brief nor the Kelly Declaration provides any assurance that the documents CMS has produced at one time or another include all of the documents that the Board's remand contemplated that CMS would produce. Indeed, the careful framing of the Kelly Declaration, together with the prior failure by CMS to respond adequately to Beechwood's requests and the ALJ's amended order, creates the appearance that CMS may have documents which it has not yet produced that would support Beechwood's position in this case. Order To determine whether the CMS failure to comply with the Board's remand order in fact prejudiced Beechwood, the Board needs to know precisely what documents CMS has in its files, whether each of these documents has in fact been produced to Beechwood either by the State or by CMS, and, if not, what, if any, valid basis does CMS have for withholding the document. Thus, we are directing CMS to do the following by June 9, 2003:
In issuing this order, we note that, to the extent that CMS does not have a valid basis for withholding documents which are relevant, these documents may ultimately be produced to Beechwood pursuant to its FOIA request and may provide a new basis for Beechwood to challenge or to seek to reopen the appeals process. In light of the lengthy history of this case, we consider it important to try to resolve as many procedural issues as possible in the current proceeding before us. If CMS identifies documents in its files that have not previously been produced to Beechwood, we will then set further procedures, if necessary. The nature of any further procedures may depend on whether some of these documents are withheld or all are produced to Beechwood in response to our order. Cecilia Sparks Ford Donald F. Garrett Judith A. Ballard ___________________ * In its reply brief in the first review proceeding, Beechwood explained that there were two problems with CMS relying on what the State had produced in the related State proceeding: first, that Beechwood had no assurance that the State's disclosure was complete, and second, that Beechwood had never been given anything from the CMS files." Beechwood Reply Br. at 6-7. Beechwood pointed out that, among other things, "CMS surveyor Michael Daniel conferred with and directed State surveyors" and Assistant Regional Administrator Sue Kelly "had numerous conversations with DOH officials about many matters" during the time frame in which the three surveys of Beechwood were conducted. Id. at 7. The reply brief refers to both the contents of the "certification file" and "all notes and work papers pertaining to Beechwood." Thus, we fail to see how CMS can reasonably assert that Beechwood got precisely what it had asked the Board to order CMS to produce. |
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| JUDGE | |
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Cecilia Sparks Ford Donald F. Garrett Judith A.
Ballard |
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| FOOTNOTES | |
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1. The facts included in this general background are drawn from ALJ Decisions I and II, which contain relevant record citations, and are presented here merely to provide a general framework for understanding the rest of our decision. The discussion here is not intended to substitute for the ALJ's findings. Where disputes about factual findings remain, we address them in the body of this decision. 2. The Health Care Financing Administration (HCFA) is the former name of CMS. See 66 Fed. Reg. 35,437 (July 5, 2001). We use the old acronym in this decision in quotations from older decisions and documents which used it, and in retaining the ALJ's denomination of HCFA Exhibits. 3. Regulations require a party seeking review by the Board of an ALJ decision to "specify the issues, the [FFCLs] with which the party disagrees, and the basis for contending that the findings and conclusions are incorrect." 42 C.F.R. § 498.82(b). ALJ Decision I contained four numbered FFCLs, with FFCL No. 4 broken down into two parts, (a) and (b), with part (b) having six subparts, (i) through (vi). ALJ Decision II contained nine numbered FFCLs. 4. Many issues raised in Beechwood's present appeal were already addressed in our prior decision. We discuss them further below only to the extent that Beechwood has now advanced different or additional arguments or that the subsequent development of the record has generated material relevant to their resolution. Our prior resolutions of these and all other issues remain in force and should be treated as part of this final decision, except where explicitly discussed, altered, or clarified further herein. 5. It is useful to note here that evidence in the record before the ALJ was identified using a somewhat complicated scheme, largely because a good deal of material was previously submitted at a State hearing. The ALJ accepted portions of the State record (previously stamped with numbers, most beginning with M) that were designated by the parties for his consideration. The designated pages were not necessarily consecutive and the admitted "M exhibits" were filed in numerical order with no renumbering. Each party also submitted new exhibits, designated as "HCFA Exhibits" and "Petitioner's (P.) Exhibits" respectively. We have retained those designations in referring to exhibits in this decision. Many of these exhibits include portions of the transcript from the State hearing selected by each party. Within those exhibits, the transcript pages are presented in reduced form, i.e., four pages of testimony appear on each page of the exhibit, and we and the parties refer to page numbers within the transcript in citing testimony from these, since no new pagination of the exhibits was done. In addition, two days of in-person hearings were held before the ALJ. We refer to the transcripts of those hearings as Transcript (Tr.) with the date and page number. Finally, a few documents, discussed fully below, were excluded by the ALJ and have distinctive identifying numbers. Some exhibits were admitted during the first appeal process before the Board and are identified as Appellate (App.) exhibits. 6. Beechwood listed these exhibit numbers, skipping F15116, in its appeal to us. The ALJ described the proffered exhibits as including all the documents produced by CMS, numbered F15111-15164 except F15114. ALJ Decision II, at 4-5. Since the ALJ expressly stated that his decision to exclude applied to all the documents produced by CMS in response to the subpoena, it is immaterial for the present purposes whether Beechwood omitted to proffer F15114 and/or F15116. 7. No advance notice is required to impose state monitoring, and CMPs have their own notice provisions at 42 C.F.R. §§ 488.434 and 488.440. 42 C.F.R. § 488.402(f)(6)-(7). 8. Beechwood did not deny receipt of the first letter. 9. The exception referred to permitted challenge to the level of noncompliance where the applicable range of CMP amounts might be altered. In addition, the regulations have since been amended to permit challenge to the level of noncompliance where it would affect "a finding of substandard quality of care that results in the loss of approval for . . . a nurse aide training program." 42 C.F.R. § 498.3(b)(14)(ii). 10. As noted above, challenge is now also permitted to a finding of subst and ard quality of care which affects approval for a nurse aide training program. 11. We note that, under the regulations, the noncompliance does not need to be found to be "substantial" in order for imposition of a remedy to be authorized, since noncompliance is already defined as "any deficiency that causes a facility not to be in substantial compliance." 42 C.F.R. § 488.301. The phrasing used by the ALJ here is harmless error, however. 12. The one exception to the preponderance of the evidence standard at the ALJ level is on review of the level of noncompliance. Where such review is permitted, facilities must prove that CMS' determination was clearly erroneous. 42 C.F.R. § 498.60(c)(2). 13. Beechwood also contended that charges relating to one resident must be dismissed because the ALJ findings "did not match the scope and severity level alleged by CMS" and that those relating to three other residents also fail as a matter of law because they were derived from "monitoring visits done prior to the date" of the survey. Beechwood Br. at 39-40. These arguments have already been addressed, and we need not revisit them here. We conclude that the ALJ need not dismiss findings supported on the record either based on a supposed discrepancy between how the ALJ described the facts and the scope and severity level cited by CMS or based on the use of observations during monitoring visits. 14. Another example of the irrelevance of details of survey procedures is Beechwood's argument in regard to this tag that "not one Resident Review Sheet was properly completed by the surveyors." Beechwood Br. at 40. Such paperwork peccadillos, even if proven, would do nothing to dilute the significance of cited deficiencies unless Beechwood demonstrated that it was in fact in compliance with the requirements cited. 15. In its brief below, Beechwood pointed to physician orders changing the dosages, and noted that one dated April 15, 1999 did not mention a notification cutoff while others from May 1999 did require notification above 400. Beechwood Post-Hearing Br. in C-99-582, at 40-41; Exs. M891, 899, and 908. We see nothing in these orders that undercuts the point that Dr. Foster reviewed the April 1999 medication administration form and did not change this instruction. 16. Dr. Oskvig appeared at the State hearing as an expert and was a member of the New York State Board of Professional Medical Conduct with a background in caring for patients in nursing homes. HCFA Ex. 19, at 3363-67. 17. We do not again address this argument here since we have already held that where an earlier event exposed a failure to comply, the facility must show that it had since come into substantial compliance not merely that the particular event ended. 18. This issue is one of many in which Beechwood referred to the content or the absence of notes in the surveyor's worksheets as proving that allegations in the SOD were not based on true contemporaneous observations by the surveyors. These worksheets are generally scribbled notations, highly abbreviated and personal in style, that appear to be memory aids rather than attempts to record narrative or verbatim quotations. While a conflict between a notation and the SOD may well form reasonable grounds for cross-examination, we do not believe the ALJ erred in not viewing an absent or ambiguous notation as somehow rendering the SOD or the testimony of the surveyor inherently suspect, as Beechwood appeared to demand. Beechwood had an opportunity to cross-examine the surveyors during the State hearing from which each party submitted excerpted testimony before the ALJ, and yet failed to present evidence that it had done so. Nor did Beechwood seek to cross-examine any of the surveyors in person before the ALJ. 19. One basis that Beechwood asserted for disregarding the surveyor's report of the interview was that the ALJ had previously announced in another case that hearsay relied on by surveyors and CMS to support allegations was "inherently suspect" as "[m]ost of the allegations come from anonymous sources." Beechwood Br. at 41, quoting Beverly-Springhill, DAB CR553 (1998). The cited case was an ALJ decision which was upheld on appeal to the Board in Beverly Health and Rehabilitation Spring-Hill discussed supra. The analysis by the ALJ in that case relates to the specific hearsay statements at issue there. The resident's statements here were not anonymous, and the ALJ was within his discretion in deciding to give weight to the surveyor's testimony about them. 20. In quoting from orders, nursing notes, and other records, we have expanded some abbreviations for the benefit of reader comprehensibility. In doing so, we had reference to Dorland's Medical Abbreviations (1992), as well as context and testimony. Our parentheticals, however, are not part of the evidence and each exhibit speaks for itself. 21. Beechwood's brief mistakenly refers to this statement as testimony from the speech pathologist but the language actually comes from a progress note. See HCFA Ex. 44, at 11. 22. Beechwood argued that the surveyor's statement that the resident reporting having "almost killed herself" on the way to the bathroom should not be believed, largely because that phrase did not appear in the surveyor's handwritten worksheets. Beechwood Br. at 33; compare HCFA Ex. 9, at 5, and HCFA Ex. 12, at 1254-55, with Ex. M6588. CMS responded that the surveyor testified about what the resident told her and was not cross-examined on the point. CMS Br. at 33. The ALJ was not unreasonable in crediting the surveyor's report based on her sworn testimony of her personal recollection even though she had not made a contemporary written note of the quotation. ALJ Decision I, at 17. In any case, whether the resident reported almost falling or almost killing herself makes little difference to the material point of this information, namely, that the staff had notice that this resident was attempting to get to the bathroom herself at night and that she was not feeling secure about it. 23. Beechwood also complained that the ALJ erroneously associated the resident's gait problems with the cellulitis infection. Beechwood Br. at 31. It is not clear what the point of this assertion is, since Beechwood does not deny that the resident had gait problems, and the source of the problems is not material. In any case, the CMS nurse-surveyor testified that the swelling and pain from the cellulitis made it difficult for the resident to walk. HCFA Ex. 12, at 1254. The ALJ could reasonably have credited this testimony in reaching his findings. 24. In its post-hearing brief, Beechwood relied on the fact that neither care plan demonstrated complete dependence or total assist in bathing to prove that each could be safely left alone in the tub. Beechwood Post-hearing Br. in C-99-582, at 20-21. The ALJ was not unreasonable, however, in reading this record to establish, instead, the need of each to have a staff member present to assist and supervise bathing. This is not inconsistent with allowing each resident to do as much as possible independently during the bath. 25. At the same time, the DON nevertheless testified that she felt these two residents could safely be left alone in the tub. Pet. Ex. 2, at 3272-73. 26. Beechwood also disputed the ALJ's comment that the manufacturer's manual implied an expectation of constant supervision during bathing, arguing that such a requirement would have been stated explicitly. Beechwood Br. at 36. We disagree that the inference drawn by the ALJ was unreasonable. The manual (in the record as exhibit M1921) advises having all materials for the bath ready, states that patients should be bathed from five to ten minutes (no more than ten minutes being required), and describes in detail how the patient is to be washed and rinsed using a shower spray. Clearly, active involvement by an attendant is expected. Every action is described as being taken by someone other than the patient. Given the time allowed for bathing, it is difficult to see how each of the described steps could be accomplished and leave time for the attendant to be absent. The manual warns that only trained personnel should operate the equipment to avoid injury. Given the totality of the instructions, it was not improper for the ALJ to infer that the manufacturer did "not envision a circumstance where an individual would be left alone while in the tub." ALJ Decision I, at 19. 27. Those points were that the SOD did not mention the word drowning, that the surveyor was not "an eyewitness to any apparent risks to these individual residents," that drowning was "only one of the risks" identified in testimony, or that a different surveyor, who made a later monitoring visit to Beechwood, testified about the risks presented by a Century tub. Beechwood Br. at 35-36. 28. Beechwood also complained that the ALJ placed on it the "impossible task of disproving a negative proposition" in finding that Beechwood had "not shown how the actions of its staff did not consist of inadequate supervision of the resident." Beechwood Br. at 37, quoting ALJ Decision I, at 19. The ALJ's phrasing of this one sentence may not be felicitous, but the problem Beechwood lamented is merely semantic. The identical proposition can be phrased affirmatively. Beechwood failed to show how its staff adequately supervised the resident. 29. We reject without further discussion arguments reiterated by Beechwood in regard to this resident which have been fully addressed elsewhere in this decision. See Beechwood Br. at 22-23. These include the assertions that the surveyors should have completed resident assessment instruments and that surveyor worksheet notes (or omissions) were insufficient or in conflict with the SOD. 30. Hence, "asepsis" is defined as both "freedom from infection" and "the prevention of contact with microorganisms." Dorland's Illustrated Medical Dictionary at 147 (28th ed., 1994). 31. In light of our resolution on this issue, we need not address other arguments raised by Beechwood concerning these findings, most of which merely reiterate arguments we have rejected elsewhere. 32. In our first decision, we stated that "our analysis of whether the ALJ could properly limit his findings to the minimum deficiencies needed to provide a basis for a remedy is equally applicable to his review of the April survey." Board Decision I, at 20, n.6 (emphasis added). The ALJ suggested on remand that we had erred in stating this since he concluded that he needed to address all of the deficiency findings in order to support the particular DPOC imposed. Merely because he concluded that no limitation was proper, however, does not mean that the same analytical framework does not apply in determining whether any limitation is proper (that is, an examination of whether any unaddressed deficiency is material to the decisionmaking). The ALJ's real complaint was that he should not have been required to address any April survey findings since they might be rendered moot by a court decision upholding the DPNA and termination. First, we note that our principal conclusion was that the ALJ had improperly dismissed Beechwood's request for a hearing on the DPOC. Contrary to what the ALJ stated on remand, we did not acknowledge that the determination was not a CMS determination. Instead, we found that the State was acting as CMS's agent in imposing the DPOC. While this made the determination an appealable CMS determination (contrary to what the ALJ had originally held), it does not necessarily follow that the findings resulting in the DPOC were material to the ALJ's decisionmaking in the case as a whole. One reason for the remand was our concern about a possible connection between the April survey findings leading to the DPOC and the later findings on which the ALJ relied as a basis for the DPNA and termination; if CMS were relying for its later findings on Beechwood's failure to correct deficiencies in the particular manner specified in the DPOC, the validity of the basis for that part of the DPOC might be material to the ALJ's decisionmaking on the DPNA and termination. The ALJ based his conclusion that he needed to address all of the April survey findings on other grounds, however. Since the parties did not contest this conclusion, we do not decide here whether that conclusion was correct. 33. In its brief responding to this appeal by Beechwood, CMS excepted to the ALJ's finding that CMS failed to establish a prima facie case concerning the inadequacy of Beechwood's electronic record-keeping system under 42 C.F.R. § 488.75(l)(1) which was cited as Tag F514. As we did with CMS's attempt to except to the ALJ's rulings excluding certain documents proffered by CMS on remand, we decline to consider CMS's exception because CMS did not choose to appeal ALJ Decision II. 34. The reason to permit surveyors to review records of closed cases is made particularly clear since the April SOD was triggered by a family complaint and this tag led to the immediate jeopardy finding. HCFA Ex. 7, at 1. Were surveyors precluded from considering closed records in evaluating the care provided by a facility, they would be unable to take into account problems experienced by residents whose families had removed them or by residents who had died. Yet, it seems entirely logical that, were a serious condition to exist at a facility, those two categories of residents would be the most likely to have suffered from it. 35. The subsection cited goes on to specifically provide that the "facility must . . . not use verbal, mental, sexual, or physical abuse, corporal punishment or involuntary seclusion," but the SOD did not cite any examples of abuse, punishment or seclusion. Thus, the ALJ evaluated the deficiency against the overall requirement for policies and procedures to prohibit mistreatment and neglect. ALJ Decision II, a 10. 36. We reached the same conclusion in Barn Hill, where we noted that the ALJ's finding that the facility there "had not implemented an anti-neglect policy is also supported by the fact that Barn Hill never established what its anti-neglect policy was and how it had been implemented." Barn Hill at 11. 37. The testimony of Dr. Stornelli does not appear in the record where Beechwood cited it. Since the full transcript of the State hearing was not submitted, we must depend on the parties to identify and provide any portions on which they rely. 38. For this reason, we are not persuaded that Beechwood's cited comment from the surveyor's notes, reading "would earlier intervention [have changed] the outcome - no probably not," should be considered a "key admission." Beechwood Br. at 55, citing Ex. M5155 (brackets added around Beechwood's interpretation of actual notes which read 'd). The outcome might be unchanged in the sense that death was unavoidable but that does not necessarily mean that the resident's condition in the interim could not have been altered by timely interventions. 39. The resident's daughter testified at the State hearing that she expected her father "to die with some dignity and compassion and caring and I don't feel that that happened." HCFA Ex. 20, at 3730. 40. The PA did recall that he felt the patient was in need of more intensive services than the facility could offer and that he wanted to try to move the patient back to the emergency room because of low oxygen saturation in his blood on February 15th. Tr. at 23-25 (April 3, 2001). 41. In addition to the fact-based arguments, Beechwood contended that the ALJ erred by not "specifically determin[ing]" whether CMS made out a prima facie case of noncompliance at an immediate jeopardy level as originally cited. Id. at 60. We have already addressed Beechwood's mistaken concept that the ALJ must make a finding about scope and severity identical to that cited in the SOD or must otherwise overturn the finding. The immediate jeopardy level here did not affect the remedy available, since the DPOC is a category I remedy available whenever a facility is not in substantial compliance. 42 C.F.R. § 488.408(c). 42. Beechwood mischaracterized this testimony as merely expressing Dr. Oskvig's personal preferences, but the language is clearly about what the professional expectations would be, not what he personally would like. Cf. Beechwood Br. at 61. 43. It was undisputed that the resident suffered at least eight documented falls between March 30th and April 7th. P. Ex. 3, at 2607. 44. Dr. Foster did not explain why the aggressive behavior constituted a sign of good health, when he had earlier testified that lack of oxygen in a noncompliant resident like this with severe lung disease "may even worsen some of the behavioral problems." P. Ex. 3, at 2599. 45. In this area as well, CMS attempted to take exception to a portion of the ALJ Decision II that reached a conclusion with which CMS disagreed, specifically finding that CMS did not show that Beechwood was noncompliant with one of the subparts of the administration requirements regulation regarding clinical records. CMS Brief at 71; 42 C.F.R. § 483.75(l)(1). As we have said, we will not entertain exceptions raised by CMS on this appeal when CMS did not timely exercise its right to appeal the ALJ Decision to us. | |