SUBJECT:Northern Montana Care Center,

Petitioner,

Centers for Medicaid for Medicare Services

FINAL DECISION ON REVIEW OF
ADMINISTRATIVE LAW JUDGE DECISION

Petitioner Northern Montana Care Center appealed the June 25, 2003 decision by Administrative Law Judge Richard J. Smith (ALJ) affirming the determination by the Centers for Medicare & Medicaid Services (CMS) that Petitioner was not in substantial compliance with the requirements for participating in the Medicare program, and imposing a denial of payment for new admissions (DPNA) from May 29, 1998 through June 22, 1998. Northern Montana Care Center, DAB CR1059 (2003) (ALJ Decision).

Northern Montana disputed the ALJ's determinations that it was not in substantial compliance with four regulatory requirements comprising nine individual instances or examples of noncompliance. Northern Montana also appealed an ALJ order, issued prior to the ALJ hearing, striking some of the issues that Northern Montana raised in its submissions.

For the reasons explained in this decision, we sustain the ALJ's determination that Northern Montana was not in substantial compliance with three of the requirements for participation that the ALJ addressed, and we reverse his determination that Northern Montana was not in substantial compliance with the fourth requirement. As a DPNA may be imposed when a facility is not in substantial compliance with one or more participation requirements, we sustain his decision affirming the DPNA. We also find no error in, and accordingly affirm, the ALJ order striking certain issues.

Legal Background

Medicare is a federally-funded program of health insurance for elderly and disabled people under Title XVIII of the Social Security Act (Act). A long-term care facility, such as Northern Montana, that participates in Medicare and receives federal payments must enter into an agreement with the Secretary of the Department of Health and Human Services and comply with specific requirements set out in the Act and in the regulations at Subpart B of 42 C.F.R. Part 483. Sections 1819, 1866 of the Act.

A facility's compliance with the participation requirements is determined through periodic on-site surveys conducted by CMS or by a state survey agency under contract with CMS. ⁽¹⁾ See section 1864(a) of the Act; 42 C.F.R. §§ 488.10(a) and 488.20. Each facility must be surveyed at least once every 12 months, and more often if necessary to ensure that identified instances of noncompliance with the regulations, or deficiencies, have been corrected.  42 C.F.R. § 488.20(a). A "deficiency" is a failure to meet a participation requirement in 42 C.F.R. Part 483. 42 C.F.R. § 488.301. Based on the survey, the surveyors prepare a report (referred to as a Statement of Deficiencies or CMS Form 2567) that lists the instances of noncompliance found (deficiencies) and assigns "F-Tag" numbers to each deficiency correlating with particular regulatory requirements to which it relates, the surveyors' findings as to the scope and severity of the deficiency, and the specific findings that support the deficiency determination. See 42 C.F.R. § 488.325(a). The seriousness of a deficiency is represented in the 2567 by a letter (ranging from A to L) that corresponds to the combination of scope and severity that the surveyors determine for the deficiency.

A facility becomes subject to remedial action when it is not in "substantial compliance" with one or more participation requirements. See 42 C.F.R. § 488.400. "Substantial compliance" means a "level of compliance with the requirements of participation such that any identified deficiencies pose no greater risk to resident health and safety than the potential for causing more than minimal harm." 42 C.F.R. § 488.301. The scope and severity of deficiencies are represented by the letters A through L, with those supporting remedial action represented by the letters D through L, with D representing isolated deficiencies that cause no actual harm but which have the potential for more than minimal harm that is not immediate jeopardy, and L representing widespread deficiencies that pose the threat of immediate jeopardy. See CMS's State Operations Manual (SOM) § 7400(E); Western Care Management Corp., d/b/a Rehab Specialities Inn, DAB No. 1921, at 3-5 (2004).

Based on the determination as to scope and severity of deficiencies and other relevant factors, CMS, with recommendations from the state, may select among available remedies. 42 C.F.R. §§ 488.404, 488.406 and 488.408. The remedies that the Act and regulations specify "with respect to a finding that a facility has not met an applicable requirement," include DPNA, civil money penalties, and termination of the facility's agreement to participate in Medicare. Sections 1819(h)(2)(B), 1919(h) of the Act; 42 C.F.R. §§ 488.400, 488.406, 488.408, 488.417. A DPNA belongs to a class of remedies that must be imposed when there are "[w]idespread deficiencies that constitute no actual harm with a potential for more than minimal harm but not immediate jeopardy" or "[o]ne or more deficiencies that constitute actual harm that is not immediate jeopardy." 42 C.F.R. § 488.408(d)(2)(i) and (ii). Additionally, a DPNA may be imposed for any deficiency, except when a facility is in substantial compliance. 42 C.F.R. §§ 488.408(d)(3), 488.417; Desert Hospital, DAB No. 1623, at 5-6, n.4 (1997). A DPNA continues until either "(1) The facility has achieved substantial compliance, as determined by CMS or the State based upon a revisit or after an examination of credible written evidence that it can verify without an on-site visit" or "(2) CMS or the State terminates the provider agreement." 42 C.F.R. §§ 488.454(a), 488.417(d); section 1819(h)(3) of the Act. A facility may appeal a certification of noncompliance leading to an enforcement remedy but not the choice of remedy. 42 C.F.R. § 488.408(g)(1),(2).

Standard of Review

The standard of review on a disputed conclusion of law is whether the decision is erroneous. The standard of review on a disputed finding of fact is whether the ALJ's finding is supported by substantial evidence in the record. Guidelines -- Appellate Review of Decisions of Administrative Law Judges Affecting a Provider's Participation in the Medicare and Medicaid Programs (Guidelines)(at http://www.hhs.gov/dab/guidelines/prov.html); South Valley Health Care Center, DAB No. 1691, at 2 (1999), aff'd, South Valley Health Care Center v. HCFA, 223 F.3d 1221 (10^th Cir. 2000).

In hearing an appeal of an ALJ decision, the Board does not conduct a de novo review. St. Anthony's Hospital, DAB No. 1728 (2000). The purpose of our review is to determine if the ALJ's findings of fact are supported by substantial evidence, and if his conclusions of law are correct. Substantial evidence is "more than a mere scintilla. It means such relevant evidence as a reasonable mind might accept as adequate to support a conclusion." Richardson v. Perales, 402 U.S. 389, 401 (1971), quoting Consolidated Edison Co. v. NLRB, 305 U.S. 197, 229 (1938). Under the substantial evidence standard, the reviewer must examine the record as a whole and take into account whatever in the record fairly detracts from the weight of the decision below. Universal Camera Corp. v. NLRB, 340 U.S. 474, 488 (1951). The reviewer does not, however, reweigh the evidence nor substitute his or her judgment for that of the initial decision-maker. Casias v. Secretary of HHS, 933 F.2d 799, 800 (10^th Cir. 1991). Thus, the reviewer must not displace a "choice between two fairly conflicting views," even though a different choice could justifiably have been made if the matter had been before the reviewer de novo. Universal Camera, 340 U.S. at 488. The reviewer must, however, set aside the initial conclusions when he or she "cannot conscientiously find that the evidence supporting that decision is substantial, when viewed in the light that the record in its entirety furnishes, including the body of evidence opposed to the [initial decision-maker's] view." Id. In addition, the Board has held that an ALJ need not "cite to everything in the record which supports" the findings, but that the "evidence that the ALJ does cite must support the findings made." Reconsideration of Wesley Hal Livingston and Shoals Medical Equipment and Supply Co., Inc., DAB No. 1406, at 3 (1993). In conducting this analysis, we do not examine the evidence independently and reach our own determination as to what may be shown by a preponderance of the evidence, and then compare our finding to the ALJ's decision. Rather, the ALJ decision is the framework that shapes and guides our review. Carehouse Convalescent Hospital, DAB No. 1799, at 6 (2001).

Background

This case has a long and convoluted history. Northern Montana is a long-term care facility located in Havre, Montana. At times relevant to this appeal, Northern Montana was certified to participate in the Medicare and Medicaid programs as a provider of services. The Montana Department of Public Health and Human Services (MDPHHS) completed the initial survey of Northern Montana's facility that identified the deficiencies on appeal on April 30, 1998, and conducted a revisit survey on May 6, 1998. CMS issued its letter notifying Northern Montana of its determination that Northern Montana was not in substantial compliance with program participation requirements, and imposing the remedy of DPNA, on May 14, 1998. Northern Montana and MDPHHS engaged in informal dispute resolution in June 1998, and MDPHHS subsequently conducted a second revisit survey on June 24, 1998, after which it determined that all deficiencies with a scope and severity level of D or above had been corrected as of June 22, 1998.

The appeal was assigned to four successive ALJs. Proceedings were stayed through January 1999 at the request of the parties. CMS filed a motion to dismiss challenging the adequacy of Northern Montana's hearing request, which was denied, and a motion to strike or limit the issues to be decided in the case, in response to which the ALJ then assigned to the case issued an order limiting the issues on appeal. Northern Montana challenged that order before the ALJ, and then on appellate review before the Board, which denied Northern Montana's request for review of the ALJ order in July 2001. Hearing dates in September and October 2001 were postponed and vacated at the request of the parties, after which CMS filed a motion for summary judgment. In June 2002 the case was assigned to Judge Smith, who denied CMS's motion for summary judgment and convened an in-person hearing in Helena, Montana from September 9-12, 2002, with additional testimony taken by telephone on September 27, 2002. ALJ Decision at 2-3.

Northern Montana's appeal of an ALJ order striking issues

In addition to appealing the ALJ Decision sustaining four of CMS's deficiency findings, Northern Montana appealed an order, issued on May 15, 2001 by an ALJ previously assigned to the case, striking some of the issues that Northern Montana raised in its submissions. Those issues concerned an immediate jeopardy-level deficiency that the state survey agency identified in the initial survey but later found had been corrected, prior to CMS's issuance of its May 14, 1998 determination letter, as well as issues relating to the validity of the guidelines and other materials that CMS issues for use by state agencies conducting surveys. The immediate jeopardy-level deficiency, designated as F-Tag 221, concerned the death of a resident who, according to the survey report, was discovered between the bed and the bed's side rail with no pulse. The survey report alleged that Northern Montana inappropriately used side rails as restraints. CMS Exhibit (Ex.) 1, at 1-5. Based on the initial survey (which found other deficiencies as well), the state agency had recommended termination of Northern Montana's Medicare agreement and a DPNA. CMS's May 14, 1998 determination letter imposing the DPNA noted that the state survey agency had determined this deficiency to have been corrected, and stated that the recommended remedy of termination would not be imposed.

Northern Montana thus sought to challenge a deficiency that the state found had been corrected prior to CMS's decision imposing the DPNA. Northern Montana maintained that the corrected deficiency was a basis for the imposition of the DPNA, despite CMS's contrary representations. Northern Montana argued that the regulations permit remedies to be imposed either for each deficiency individually or for all deficiencies, and that the DPNA must thus have been based at least partially on the immediate jeopardy-level deficiency because the state survey agency had initially recommended both termination and a DPNA based on all of the deficiencies it found in its initial survey, and because CMS's determination letter did not state that remedies were being imposed for individual deficiencies. Northern Montana also argued that in the absence of the immediate jeopardy-level deficiency the state survey agency would not have recommended any remedies but would only have required submission of a directed plan of correction, and would not have imposed an extended survey, which resulted in the loss of Northern Montana's nurse aide training and certification evaluation program.

In ruling on CMS's motion to strike or limit issues, the ALJ then assigned to the case found that she had no authority to consider the immediate jeopardy-level deficiency or arguments related to it because it had been corrected and was not a basis of the DPNA before her. She also found that she had no authority to consider Northern Montana's arguments that the standards of care regarding restraints in the regulations conflicted with federal law, and that CMS survey materials and guidelines were invalid for not having been promulgated in accordance with the Administrative Procedure Act.

Northern Montana sought interlocutory review of the May 15, 2001 ALJ order before the Board. In a ruling dated July 26, 2001, the Board declined to hear the appeal as premature. The Board held that the regulations did not require that the Board consider a request for review of an ALJ order that dismisses some issues but does not finally dispose of a pending case. The Board also suggested that the ALJ consider whether some of the issues that she struck on the ground that they related to the immediate jeopardy deficiency citation in fact related to other deficiencies that CMS cited in its May 14, 1998 determination and which were undisputably a basis for the DPNA. In a ruling dated August 31, 2001, the ALJ thus expanded the issues on appeal in accord with the Board's suggestion. The Board in its ruling also determined that, in the interest of judicial economy, consideration of Northern Montana's arguments against dismissal of issues should be deferred until such time as Northern Montana appealed an ALJ decision that finally disposed of all of the issues that the ALJ determined to be properly under review. That time has arrived.

We conclude that the ALJ did not err in striking Northern Montana's issues regarding the immediate jeopardy deficiency. The regulations state that CMS or the state may apply one or more remedies for each deficiency or for all deficiencies rendering a facility out of substantial compliance. 42 C.F.R. § 488.402(c). Here, the state agency only recommended but never imposed the termination, and found that the immediate jeopardy deficiency had been corrected prior to CMS's determination on May 14 to impose remedies. CMS's letter noted that the immediate jeopardy deficiency had been corrected, and indicated that the remedy of DPNA would be imposed prospectively from May 29, and further indicated that CMS would also be required to impose the DPNA "[i]f we do not impose the above remedy due to a lessening of scope and severity of the above cited deficiencies and your facility does not achieve substantial compliance within three months after the last day of the survey identifying noncompliance (July 30, 1998)..."

The fact that the immediate jeopardy deficiency was corrected prior to the May 14 determination to impose the DPNA is not conclusive, but is some evidence that CMS did not initially intend to base the DPNA on that deficiency. In any event, even if CMS initially based the DPNA on that deficiency as well as the other 22 deficiencies found in the initial survey (as CMS's motion to dismiss the hearing request later suggested by stating that the DPNA was based on 23 deficiencies), the hearing procedures at Part 498 contemplate that the issues for hearing may be modified to account for subsequent actions. See, e.g., 42 C.F.R. §§ 498.30, 498.49(b), 498.56. Since CMS would be permitted to withdraw its reliance on a particular deficiency as a basis for a remedy, we see no reason why CMS should not be able to clarify that it did not intend in the first instance to base a remedy on a particular deficiency. We recognize why the facility here might want a hearing on the issue of whether in fact it had a deficiency at the immediate jeopardy level. Once CMS had clarified that it was not relying on that deficiency as a basis for the DPNA, however, the ALJ could properly determine that it was not an issue for hearing. Focusing the hearing process on issues material to the ALJ's decision making saves resources for all involved. Northern Montana's speculation that the state survey agency would not have recommended any remedies in the absence of the immediate jeopardy-level deficiency does not provide a basis to overturn the remedy that CMS selected. See Beverly Health and Rehabilitation -- Spring Hill, DAB No. 1696, at 16-17 (1999) ("the speculation that HCFA might have acted differently had circumstances been different does not imply that HCFA was compelled to alter its choice of remedy because some of the deficiencies were overturned on appeal."), aff'd, Beverly Health & Rehabilitation Servs. v. Thompson, 223 F.Supp.2d 73 (D.D.C. 2002); see Golden State Manor and Rehabilitation Center, DAB No. 1597, at 15-23 (1996).

Next, we conclude that Northern Montana had no right to present evidence before the ALJ regarding the immediate jeopardy deficiency. Before the Board, Northern Montana clarified that it was not seeking to set aside CMS's action because of alleged constitutional or other infirmities, but arguing only that it should have the opportunity to introduce evidence, advance arguments and develop a record concerning those issues that the ALJ had no authority to decide. Request for Review of ALJ Ruling at 22-23; Request for Review of ALJ Decision at 8. Northern Montana argued that the statute authorizing judicial review of Board decisions in nursing home termination and DPNA cases forbids Northern Montana from introducing such evidence before the Board if a court remands the case to the Board, except in circumstances not applicable here. Section 205(g) of the Act, 42 U.S.C. § 405(g). Northern Montana also cited the Supreme Court's holding in Shalala v. Illinois Council on Long Term Care, Inc. 529 U.S. 1 (2000), that an appellant must channel all of its claims through the ALJ and Board administrative hearing process, even those claims that the ALJ and the Board lack authority to address. Northern Montana argued that these proceedings are thus its only opportunity to develop an evidentiary record concerning the immediate jeopardy deficiency at F-Tag 221. (Northern Montana also argued that regulations precluding the right to a hearing unless sanctions are imposed and which otherwise limit the scope of administrative review available to Northern Montana violated its constitutional right to due process. Northern Montana stated that it was raising these constitutional issues to preserve them for judicial review. Request for Review at 9, n.4.)

Northern Montana overlooks language in section 205(g) that provides a court with other remand powers than those that Northern Montana cited. The language that Northern Montana cited that appears to limit an appellant's ability to present evidence is found in the sixth sentence of section 205(g) of the Act. As made applicable to these appeals by the Medicare statute, the sixth sentence provides that a court may remand a case to HHS for further action, and may at any time order additional evidence to be taken by HHS, "but only upon a showing that there is new evidence which is material and that there is good cause for the failure to incorporate such evidence into the record in a prior proceeding; . . ." ⁽²⁾ However, the fourth sentence of section 205(g) provides a court with other powers to review (and remand) our decision, without the evidentiary restriction imposed by the sixth sentence. The fourth sentence of section 205(g) states that "[t]he court shall have power to enter, upon the pleadings and transcript of the record, a judgment affirming, modifying, or reversing the decision of the [Secretary], with or without remanding the cause for a rehearing." The Supreme Court has found that the powers afforded in the two sentences are separate and distinct, with the sixth sentence that Northern Montana cited being intended for an appeal based on the discovery of new evidence, which, according to Northern Montana's arguments, would not be the basis of its appeal of this decision. Where an appeal is not based on the discovery of new evidence but instead challenges the underlying correctness of the decision, sentence four is the appropriate basis of the appeal, and does not contain the evidentiary restriction of the sixth sentence. See Sullivan v. Finkelstein, 496 U.S. 617, 626 (1990); Melkonyan v. Sullivan, 501 U.S. 89, 98 (1991); see also Faucher v. Secretary of Health and Human Services, 17 F.3d 171, 173-75 (6^th Cir. 1994).

Moreover, as we pointed out in our prior order denying Northern Montana's request for interlocutory review of the ALJ order striking issues, the Court in Illinois Council noted that a federal court reviewing an HHS determination under section 205(g) has adequate authority to resolve any statutory or constitutional claims, "including, where necessary, the authority to develop an evidentiary record." Id. at 1099. In this respect, Northern Montana mistakes the requirement that it present its arguments to the ALJ and the Board in order to preserve them for court review, for a requirement that the Board receive evidence and develop a record on the factual issues underlying Northern Montana's arguments. Nothing in the authorities Northern Montana cited supports the notion that we must expend resources holding an evidentiary proceeding on a deficiency that was not before the ALJ or on matters that the ALJ had no authority to address. Should a court agree with Northern Montana's arguments disputing our decision, Northern Montana would have ample opportunity on remand to present evidence underlying its claims.

Finally, we conclude that the ALJ properly dismissed Northern Montana's challenges to the validity of the regulations and CMS's survey materials. In other cases the Board has rejected petitioners' arguments that CMS's survey materials were invalid for not being promulgated under the APA, finding it irrelevant to the question of whether a petitioner can demonstrate that it was in substantial compliance with the applicable standards of participation. Hermina Traeye Memorial Nursing Home, DAB No. 1810, at 22-23 (2002), aff'd, Sea Island Comprehensive Healthcare Corp., d/b/a Hermina Traeye Memorial Nursing Home v. Dep't of Health & Human Servs., No. 02-2076 (4^th Cir. Oct. 29, 2003); Golden State Manor and Rehabilitation Center, at 15-23. Northern Montana also argued that regulations precluding the right to a hearing unless sanctions are imposed and otherwise limiting the scope of administrative review available to Northern Montana violated Northern Montana's constitutional right to due process. Northern Montana stated that it was raising these constitutional issues to preserve them for judicial review. Request for Review at 9, n.4. In any event, we have observed that challenges to the constitutionality of a statute or of a regulation promulgated by an agency are generally beyond the power or the jurisdiction of an ALJ or an administrative review body. See Sentinel Medical Laboratories, Inc., DAB No. 1762, at 9 (2001), aff'd, Teitelbaum v. Health Care Financing Admin., No. 01-70236 (9^th Cir. Mar. 15, 2002), reh'g denied, No. 01-70236 (9^th Cir. May 22, 2002).

Northern Montana's appeal of the deficiency findings

In his decision, the ALJ addressed four of the 13 "F-Tag" deficiencies from the CMS 2567 that were at issue at the time of the hearing, following informal dispute resolution between Northern Montana and MDPHHS, and MDPHHS's determination, prior to CMS's decision to impose the DPNA, that the immediate jeopardy deficiency labeled F-Tag 221 had been corrected.

Northern Montana objected to the ALJ's failure to address all of the deficiency findings. However, as the ALJ noted, CMS is authorized to impose a DPNA based on a facility's failure to comply substantially with a single participation requirement. The ALJ's finding that Northern Montana failed to comply substantially with four regulatory requirements for participation required him to uphold the DPNA. ALJ Decision at 5, citing Beechwood Sanitarium, DAB No. 1824, at 19-22 (2002). We conclude that this exercise of judicial economy in declining to address deficiency findings that were not material to his decision making was within his discretion and provides no basis to reverse his decision. ⁽³⁾

The ALJ made five numbered Findings of Fact and Conclusions of Law (FFCLs). In FFCLs Nos. 1-4, the ALJ found that Northern Montana was not in substantial compliance with each of the four regulatory requirements of participation that he addressed in his decision. In FFCL No. 5, the ALJ found that CMS thus had a basis to impose a DPNA, and that he did not have the authority to modify that remedy.

Below, we address the individual deficiencies in the order in which they appear, grouped by F-Tag, in the ALJ Decision. As explained, we sustain three and reverse one of his four FFCLs that Northern Montana was not in compliance with applicable participation requirements. For one of the FFCLs that we sustain, we nevertheless reverse his findings with respect to one resident while sustaining this FFCL as there were findings of noncompliance for two other residents. As we find that Northern Montana was not in substantial compliance with at least one requirement of participation, we find that CMS had a basis to impose a DPNA, and we thus sustain the FFCL to that effect.

F-Tag 272

Under F-Tag 272, CMS found Northern Montana was not in substantial compliance with provisions of 42 C.F.R. § 483.20(b) requiring that facilities periodically conduct comprehensive assessments of residents. As in effect at the time of the survey, that regulation, titled "resident assessment," stated that:

The facility must conduct initially and periodically a comprehensive, accurate, standardized, reproducible assessment of each resident's functional capacity. . .

(b) Comprehensive assessments. (1) The facility must make a comprehensive assessment of a resident's needs, which--
(i) Is based on a uniform data set specified by the Secretary and uses an instrument that is specified by the State and approved by the Secretary; and
(ii) Describes the resident's capability to perform daily life functions and significant impairments in functional capacity.
(2) The comprehensive assessment must include at least the following information:

(i) Medically defined conditions and prior medical history;
(ii) Medical status measurement;
(iii) Physical and mental functional status;
(iv) Sensory and physical impairments;
(v) Nutritional status and requirements;
(vi) Special treatments or procedures;
(vii) Mental and psychosocial status;
(viii) Discharge potential;
(ix) Dental condition;
(x) Activities potential;
(xi) Rehabilitation potential;
(xii) Cognitive status; and
(xiii) Drug therapy.

(3) [Reserved]

(4) Frequency. Assessments must be conducted--
(i) No later than 14 days after the date of admission;
(ii) For current NF residents not later than October 1, 1991;
(iii) For current SNF residents not later than January 1, 1991;
(iv) Promptly after a significant change in the resident's physical or mental condition; and
(v) In no case less often than once every 12 months.
(5) Review of assessments. The nursing facility must examine each resident no less than once every 3 months, and as appropriate, revise the resident's assessment to assure the continued accuracy of the assessment.
(6) Use. The results of the assessment are used to develop, review, and revise the resident's comprehensive plan of care, under paragraph (d) of this section.
(7) Coordination. The facility must coordinate assessments with any State-required preadmission screening program to the maximum extent practicable to avoid duplicative testing and effort.

56 Fed. Reg. 48,871 (Sept. 26, 1991), as amended at 57 Fed. Reg 43,924 (Sept. 23, 1992).

As described in the ALJ Decision, the assessment process entails the use of a "minimum data set" (MDS) to prepare various assessments, including a 14-day assessment, an annual assessment, and a significant change assessment, which are all comprehensive assessments. These assessments include "resident assessment protocols" (RAPs), which are generated by certain identified data elements answered in an MDS assessment. The RAPs allow the individual completing the assessment to pursue a problem or concern a resident is having. ALJ Decision at 6, citing hearing transcript (Tr.) at 40-42.

CMS determined that Northern Montana failed to comprehensively assess residents, that assessments contained inaccuracies and were incomplete, that information that the surveyors gained through observations and/or interviews was inconsistent with data in the residents' assessment instruments, and that the facility failed to gather further information on triggered Resident Assessment Protocols (RAPs) in an effort to comprehensively assess residents' needs or declines in function. CMS Ex. 1, at 20-22. The ALJ found that Northern Montana failed to comply with this regulation in its conduct of comprehensive assessments for three residents, nos. 8, 28, and 5. FFCL No. 1, ALJ Decision at 6. We address each resident in turn, in the same order as the ALJ.

Resident 8

CMS's findings regarding resident 8 were based on a decline in her ambulation and a swallowing disorder. Regarding the swallowing disorder, CMS alleged that although the resident had a diagnosis of longstanding dysphagia and was on a specialized swallowing protocol developed by the speech therapist, the facility assessed the resident in a nutritional status RAP as having no difficulty swallowing and did not address whether the resident needed assistance with feeding. CMS Ex. 1, at 23.

Resident 8: swallowing

The ALJ found that resident 8's Nutritional Status RAP did not refer to the resident's need for help in feeding that was noted in her comprehensive assessment, and did not address adequately the resident's swallowing difficulty, which was reflected in a swallowing protocol prepared for the resident by a speech therapist in December 1997. ALJ Decision at 7-8, citing Northern Montana Ex. 8, at 29. The ALJ found that omitting such key information defeats the purpose of the RAP, which is to more closely pursue a resident's problems in order to care plan for the resident. ALJ Decision at 8.

The essence of Northern Montana's argument on appeal is that the MDS for this resident was accurate, as acknowledged by the ALJ, because it reflected that the resident needed assistance with feeding, and that the "perceived inadequacy" of the nutritional status RAP was not sufficient to support a finding of a deficiency because there are no specific regulatory or other requirements for RAPs. Request for Review at 15. The latter point related to an overarching argument that Northern Montana made for this deficiency tag in general. Northern Montana argued that there are no specific requirements that changes in a resident's condition, or notes and findings regarding the resident's condition, must be immediately documented in all of the resident's records. Northern Montana argued that facility staff from different disciplines (i.e. nursing, social work) will make different types of findings and observations, and that due to the inherently complex nature of the various assessment instruments that facilities are required to complete, and the fact that the various staff members who see residents make different observations depending on their particular disciplines, a resident's records may at any given time contain seemingly different findings. Northern Montana argued that staff meet periodically to discuss and reconcile these various findings and observations and update the resident's records accordingly. Northern Montana argued that the complex nature of the assessment process is apparent from materials that CMS has issued providing guidance on the assessment process, and was recognized in a report of the HHS Office of Inspector General on nursing home assessment and in hearing testimony from witnesses for Northern Montana and CMS. CMS cited the HCFA Resident Assessment Instrument (RAI) User's Manual," Version 2.0, October 1995 (particularly Chapter 4, "Procedures for completing the resident assessment protocols (RAPs)"), and the HCFA "Long Term Care Resident Assessment Instrument Questions and Answers," Version 2.0, August 1996. Northern Montana Exs. 52, 53. Northern Montana cited these materials as establishing that there are no requirements regarding the process of how facility staff use or document RAPs, as encouraging facilities to be creative and to experiment until they find what works most efficiently for them, and as stating that the decision regarding the adequacy of a resident assessment depends on whether the resident received appropriate care. Northern Montana Request for Review at 12-14, citing Northern Montana Exs. 52, 53. Thus, seeming inconsistencies in resident documentation "actually are evidence that [Northern Montana] made proper use of an interdisciplinary team process and appropriately completed the RAP and care planning processes in compliance with the regulations." Northern Montana Request for Review at 14.

The ALJ addressed this argument in his analysis of CMS's findings for another resident under this deficiency tag, resident 5. The ALJ found that Northern Montana did not deny CMS's findings regarding inconsistencies in Northern Montana's records, such as inconsistencies in responses on RAP summaries, but instead speculated as to why those inconsistencies exist, and also had not demonstrated that it actually assessed these inconsistencies. ALJ Decision at 10. Earlier, in his discussion of the assessment process, the ALJ observed that the RAPs are part of the comprehensive assessments required by the regulation. "The minimum data set (MDS) is used to prepare various assessments, including a 14-day assessment, an annual assessment, and a significant change assessment, which are all comprehensive assessments. They include the RAPs (resident assessment protocols), which are generated by certain identified data elements answered in an MDS assessment." ALJ Decision at 6.

The ALJ's conclusion that the RAPs are part of the comprehensive assessment required by (and thus subject to) the regulation is consistent with the CMS assessment materials that Northern Montana introduced. The HCFA Resident Assessment Instrument (RAI) Version 2.0 Manual (October 1995) states:

The MDS alone does not provide a comprehensive assessment. Rather, the MDS is used for preliminary screening to identify potential resident problems, strengths, and preferences. The RAPs are problem-oriented frameworks for additional assessment based on problem identification items (triggered conditions). They form a critical link to decisions about care planning. The RAP Guidelines provide guidance on how to synthesize assessment information within a comprehensive assessment. The Triggers target conditions for additional assessment and review, as warranted by MDS item responses; the RAP Guidelines help facility staff evaluate "triggered" conditions... The RAI (MDS and RAPs) is an integral part of this process.... It is helpful to think of the RAI as a package. The MDS identifies actual or potential problem areas.

Northern Montana Ex. 52, at 248-49. Thus, there was no error in the ALJ's conclusion that the RAPs were as much a part of the required comprehensive assessment as was the MDS, and the regulation applied with equal force to the former as well.

Here, resident 8 was noted to have a diagnosis of dysphagia ("difficulty in swallowing" --Dorland's Medical Dictionary, 28^th ed., at 517) in December 1997. Northern Montana Ex. 8, at 25-29; ALJ Decision at 8. The speech therapist at that time developed a protocol that centered on ensuring that the resident ate with her dentures in, took small bites, and took in liquids. Id. at 29. As the ALJ pointed out, the protocol and the therapist's screening evaluation both refer to "swallowing." While the speech therapist's notes indicate that the goal of addressing the resident's problem of "pocketing" food was met, the protocol for continued oversight by care staff could reasonably be read by the ALJ as meaning that the swallowing difficulty continued, even if mitigated. Northern Montana presented no evidence that, as a result of the therapy, the resident's diagnosis of dysphagia was viewed as merely part of her medical history, and not as an ongoing problem. Although Northern Montana suggested that this resident did not really have a swallowing disorder, but rather difficulty in chewing, both the surveyor and Northern Montana's resident care coordinator, a geriatric nurse, testified that the resident had dysphagia that was probably related to a stroke she had suffered. Tr. at 230, 415-16, 482.

Despite these findings, the resident's most recent MDS prior to the survey, completed on March 4, 1998, while indicating that she needed assistance with eating and had received a mechanically altered diet in the past seven days, stated that she had neither a chewing problem nor a swallowing problem. Northern Montana Ex. 8, at 16; CMS Ex. 17, at 18. Northern Montana's characterization of the ALJ's finding was not correct. While the ALJ agreed that the MDS noted that resident 8 needed help in feeding (ALJ Decision at 7-8, citing Northern Montana Ex. 8, at 16), he did not find that the MDS was therefore accurate with respect to this deficiency.

The nutritional status RAP that the surveyor examined (which was triggered by the MDS notation of a mechanically altered diet), while stating that the resident had a reduced ability to feed herself, did not indicate whether she required assistance with feeding, adaptive equipment, or specialized training (the space in which Northern Montana was to so indicate is blank). CMS Ex. 17, at 20-21. Moreover, the RAP stated that she did not have difficulty chewing or swallowing. Id. at 21.

The plan of care resulting from the resident assessment at issue did include some of the interventions that were part of the speech therapist's protocol. Some were not reflected, however. For example, no reference is made in the plan of care to the need for the resident to use her dentures to eat, and survey documents indicate that she was observed eating without them. Thus, we reject Northern Montana's suggestion that the resident assessment process resulted in appropriate care and therefore met the standard in CMS guidance. The ALJ's finding that Northern Montana was not in substantial compliance with that regulation was supported by substantial evidence, and contained no error of law.

Northern Montana's argument regarding the time needed to consolidate the findings of staff members from different disciplines into the comprehensive assessment might have some merit in the context of new findings or changed conditions, but has no merit here, where the particular information about the resident that was absent from the RAP -- her need for assistance with feeding, and her history of difficulty with swallowing -- had earlier been noted in the MDS, and in the resident's records dating back to December 1997.

Northern Montana also argued that its care of resident 8 with respect to her ability to eat was not deficient because the resident did not lose weight. While this fact could support an inference that the problem was not affecting her nutritional status, it does not show that the resident was not in danger if the swallowing protocol was not followed. Moreover, in addressing this same argument in another appeal, the Board held that even if the facility's noncompliance did not harm the resident in question, this would not make the deficiency findings improper. The preamble to the regulations governing the survey and certification of long term care facilities states that "[a] violation of any participation requirement must be considered a deficiency, even if the violation caused no negative outcome to occur." 59 Fed. Reg. 56,227 (Nov. 10, 1994); Lake City Extended Care Center, DAB No. 1658, at 22-24 (1998).

Resident 8: ambulation

Regarding resident 8's ambulation, CMS determined that the ADL RAP failed to assess a decline in resident 8's ambulation that took place between her assessment in December 1997, when she was noted as needing extensive assistance with ambulation, and her assessment in March 1998, at which point no ambulation was occurring. CMS found that the ADL RAP did not include an assessment of or reason for this decline, or what measures had been attempted to prevent it. CMS Ex. 1, at 22-23. Before the ALJ, CMS noted that the summary of the ADL RAP reported that resident 8 had limited potential for improvement and that Alzheimer's disease impacted her ability to perform ADLs, but that Northern Montana answered "no" in the same RAP to the question of whether the resident had cognitive factors which impacted ADL functional ability. ALJ Decision at 8, citing CMS Ex. 17, at 39, CMS Br. at 16. Northern Montana argued before the ALJ that resident 8's change in ambulation was clearly documented in the nurses' notes (Northern Montana Ex. 8, at 48-52); that the ADL RAP was completed and accurate as evidenced by the surveyor's finding on the 2567; and that the changes were the unavoidable outcome of the progression of her disease. ALJ Decision at 8, citing Northern Montana Br. at 35.

The ALJ disagreed that the nurses' notes clearly noted a change in ambulation. He agreed with CMS that the ADL RAP was not complete and accurate, because it did not address resident 8's decline in ambulation and stated that the resident had no cognitive factors impacting her ADL functional status, whereas resident 8 did have such factors, which were noted in the RAP's summary of findings section. ALJ Decision at 8, citing CMS Ex. 17, at 39. As with the findings related to this resident's dysphagia, the ALJ found that the assessments that Northern Montana completed for resident 8 were incomplete, inaccurate, and not a comprehensive assessment of the resident's needs and/or decline in function. ALJ Decision at 7.

On appeal to the Board, Northern Montana no longer argued that the decline in the resident's ambulation was the unavoidable result of the progression of her disease. Instead, Northern Montana argued that the decline in ambulation during the 7-day assessment period in March 1998, when the MDS was being prepared, was due to her having been on antibiotic treatment for a urinary tract infection, noting that she stated to staff that she did not feel well. Northern Montana Ex. 8, at 48. Northern Montana argued that its staff knew these well-documented facts and there was thus no reason for them to engage in additional assessment of her ambulation status.

As CMS argued, Northern Montana did not dispute the accuracy of the ALJ's factual findings regarding the contents of the records for resident 8. As the ALJ found, the ADL RAP for resident 8 contained conflicting information about whether or not her decline in cognitive abilities impacted her ADLs. The ADL RAP that the surveyors examined stated on the same page both that the resident had no cognitive factors impacting ADL functional status and that her diagnosis of Alzheimer's disease impacted her ability to perform more ADLs. CMS Ex. 17, at 39. Northern Montana did not dispute that the resident's ability to ambulate was among her ADLs. By presenting such conflicting information, the RAP, which was part of the comprehensive assessment required by the regulation, failed to meet the regulation's requirement that the assessment describe the resident's capability to perform daily life functions and significant impairments in functional capacity, and must be comprehensive and accurate. 42 C.F.R. § 483.20(b)(1)(ii).

Additionally, the evidence does not support Northern Montana's argument that the decline in ambulation around the time of the March MDS was a temporary result of a urinary tract infection. This assertion, which Northern Montana did not make before the ALJ, is not supported by the record. Although Northern Montana's resident care coordinator testified that the resident would experience a temperature and become lethargic when beset with a urinary tract infection, she did not state that the decline in the resident's ability to ambulate was due to such an infection. Moreover, the records examined by the surveyor indicated that the resident experienced multiple urinary infections, including during November and December 1997, when her ability to ambulate was noted to be superior to her ability during the March 1998 assessment; Northern Montana's witness also testified that the resident had a history of multiple, chronic urinary infections. CMS Ex. 17, at 3-4; Tr. 479-80, 488. Thus, even if no assessment is required where there is a temporary change in a resident's condition due to a known cause, there is no basis to find that this was the case here.

Resident 28

CMS found that Northern Montana's assessment of resident 28 failed to comply substantially with 42 C.F.R. § 483.20(b) because the October 1997 MDS for the resident did not indicate that edema was "a problem condition," whereas physician progress notes dating back to September 9, 1997 showed that she had a longstanding history of edema in her right arm and left leg; this edema was observed on all days of the survey. CMS Ex. 1, at 23.

The exhibits that both parties designated as concerning this resident do not contain the physician's notes for September 9, 1997, the MDS from October 1997, or any surveyor notes addressing the resident's edema. However, before the ALJ, Northern Montana did not dispute the factual findings in the form 2567. ALJ Decision at 9. Instead, Northern Montana argued that CMS's instructions for preparing the relevant section of the MDS dealing with edema require it to be based on whether the resident actually had the condition during the previous seven days, and that Northern Montana would thus not have been expected to note a history of edema noted in records from a month earlier, outside of the seven-day assessment period. The ALJ rejected this argument, citing portions of the CMS instructions indicating that a review of a resident's record, including recent physician notes or orders, is to be used in completing the RAI. Id., citing Northern Montana Ex. 52, at 43.

On appeal, Northern Montana again argued that the applicable CMS guidance called for the MDS assessment of edema to be based on actual observations in the last seven days, whereas the deficiency finding was based not on the presence of edema during the relevant observation period for the October 1997 MDS, but on physician notes.

We reverse the deficiency finding with respect to this resident. The 2567 reports that the MDS completed for this resident in October 1997 failed to list edema as "a problem condition." CMS Ex. 1, at 23. The portion of the CMS RAI manual that Northern Montana cited lists edema as one of the "problem conditions" to be noted in section J of the MDS, "health conditions." Northern Montana Ex. 52, at 172-73. As Northern Montana argued, the instructions for completing this section call for the listing of conditions that have been present in the previous seven days. Here, CMS did not allege in the 2567, or demonstrate at the hearing, that the resident had edema during the seven days prior to the October 1997 MDS. The ALJ did not find that the resident had edema during that period, but simply accepted CMS's argument that Northern Montana should have noted the prior history of edema based on the instructions for completing the RAI. However, as we discussed above, the RAI encompasses more types of required documentation than the MDS, whereas here the deficiency is based solely on the absence of information on edema from the MDS completed in October 1997. CMS did not point to a specific requirement that a history of edema (as opposed to the presence of edema in the past seven days) be noted in the MDS. In this regard, CMS's specific instructions for completing the portion of the MDS where edema would be noted are of more relevance than the more general instructions for the conduct of the entire assessment process. CMS also did not show where on the MDS a history of edema would be indicated, and the portions of the MDS forms that CMS introduced for this resident contain no specific question regarding the presence of edema. ⁽⁴⁾ CMS moreover did not allege that any other specific type of documentation that Northern Montana was required to complete for this resident as part of the RAI was defective for failing to note the history of edema. Accordingly, we conclude that CMS did not establish a prima facie case that Northern Montana failed to comply substantially with the requirement of the regulation with respect to this resident, and we reverse the ALJ's finding pertaining to resident 28.

Resident 5

According to the CMS form 2567, this deficiency was based on the alleged presence of conflicting information, in components of the resident's comprehensive assessment, about the resident's cognitive status and ADLs. The 2567 reported the following information: this resident was admitted to Northern Montana's facility on June 1, 1997, with diagnoses of organic brain syndrome, confusion, forgetfulness, and inability to care for self. The RAP information for the cognitive loss/dementia medical factors stated that the resident had dementia, but also that the resident did not have medical conditions or diagnoses that impact cognitive status. The RAP summary stated that the resident had no signs of cognitive loss, and was able to perform ADLs despite poor eyesight, while the RAP summary on psychosocial well-being stated that the resident had a diagnosis of dementia that affects cognitive functioning. CMS Ex. 1, at 25-26.

According to the ALJ Decision, Northern Montana did not deny the accuracy of the findings in the 2567, but instead made the arguments regarding the complexity of the assessment process that we addressed above with respect to resident 8. As noted above, the ALJ correctly rejected this argument. The ALJ also noted that the RAP reported that the resident had exhibited verbal expressions of distress and sad, apathetic, or anxious appearance in the last 30 days, but the MDS assessment did not indicate this. As with resident 28 above, the ALJ found that Northern Montana did not deny CMS's findings but instead speculated as to why inconsistencies exist in the record. The ALJ also found that Northern Montana had not demonstrated that it actually assessed these inconsistencies.

Before the Board, Northern Montana essentially argued that the surveyors and the ALJ took individual questions in the RAPs out of context and thus misunderstood their purpose. Northern Montana argued that there were thus reasonable explanations for seeming inconsistencies in the resident assessment materials. For example, Northern Montana argued that the statement in the RAP that there is no sign of cognitive loss, when read in conjunction with the statement earlier in the same paragraph that the resident's cognitive status had not changed within the last three months, means simply that there was no sign of additional cognitive loss within those last three months. However, while this explanation may be reasonable, explanations of other inconsistencies that Northern Montana offered do not support Northern Montana's argument.

One of these other inconsistencies was the finding that the RAP information for the "Cognitive Loss/dementia" medical factors stated the resident had dementia, but also that the resident did not have medical conditions or diagnoses that impact cognitive status. Northern Montana's argument was that the wording and structure of this portion of the RAP show that the question about whether the resident had medical conditions or diagnoses that impact cognitive status referred to medical conditions or diagnoses other than dementia, or Alzheimer's disease. However, that argument is not borne out by a reading of the section of the RAP containing the questions at issue.

The two questions are contained in one of six sections of the RAP for "Cognitive Loss/dementia" that is titled "Medical Factors for Consideration." This section contains the following nine questions:

(1) Within the last 90 days has there been a decline in cognitive status?
(2) Within the last 7 days has resident exhibited episodes of delirium (i.e., periodic disordered thinking/awareness)?
(3) Does resident have a diagnosis of mental retardation or developmental disability?
(4) Is resident's cognitive status affected secondary to diagnosis of Alzheimer's disease or other dementia?
(5) Does resident have any of the following medical conditions (constipation, diarrhea, fecal impaction, Cancer, Diabetes, Hypothyroidism, Emphysema/COPD, Other cardiovas. diseases, CHF, UTI, Pain)?;
(6) Is the resident using any of the following classifications of medications (Antipsychotic, Antianxiety, Antidepressant, Hypnotics, Diuretics, Analgesics)? If Yes, have cognitive skills declined since initiation of medications?
(7) Does resident have a terminal prognosis?
(8) Is resident at nutritional risk (i.e., low weight for height, weight loss)?
(9) Based on the above review, does the resident have medical condition(s) or diagnosis(es) that impact cognitive status?

As noted above, Northern Montana answered "yes" to the fourth question (is resident's cognitive status affected secondary to diagnosis of Alzheimer's disease or other dementia?) but also "no" to the ninth question (based on the above review, does the resident have medical conditions or diagnoses that impact cognitive status?).

Northern Montana argued that the ninth question was not intended to refer to the Alzheimer's disease or other dementias addressed in the fourth question, but only to the 11 medical conditions addressed in the fifth question. Northern Montana paraphrased the ninth question as asking "Based on the above review (i.e., of medical conditions other than Alzheimer's disease or other dementia)," does the resident have medical conditions or diagnoses that impact cognitive status? Northern Montana Request for Review at 18.

Nothing in the wording or structure of this section of the RAP supports Northern Montana's contention. The ninth question asks if the resident has a medical condition or diagnosis that affects his or her cognitive status, and the fourth question asks if cognitive status has been affected by Alzheimer's disease or other dementia. Northern Montana did not argue that Alzheimer's disease and dementia are not medical diagnoses, and the list of possible diagnoses contained in the MDS category titled "Disease Diagnoses" includes both Alzheimer's and dementia other than Alzheimer's. Northern Montana Ex. 5, at 9. There is nothing to indicate that the "above review" mentioned in the ninth question was intended to refer only to "medical conditions(s) or diagnosis(es)" listed in question five, and not a diagnosis of Alzheimer's or other dementia mentioned in question four. Given that the entire category addresses cognitive loss and dementia, it is not surprising that one question would be devoted solely to diagnoses of Alzheimer's disease and other dementias, whereas the following question would concern 11 other medical conditions. Significantly, none of the other five sections of the RAP for "Cognitive Loss/dementia" (mood factors for consideration, behavioral factors for consideration, functional factors for consideration, sensory factors for consideration, psychosocial factors for consideration) asks about Alzheimer's. It is only in the medical conditions category that a facility has an opportunity to note and describe the effects of Alzheimer's disease or other dementia. Accordingly, the ALJ's conclusion that Northern Montana did not comply with the requirements of section 483.20(b) with respect to this resident was not erroneous.

We sustain the ALJ's deficiency findings under this tag regarding residents 8 (both as to ambulation and dysphagia) and 5, and reverse his deficiency finding for resident 28. Accordingly, we sustain the ALJ's FFCL No. 1, that as of the survey ending on April 30, 1998, Northern Montana was out of substantial compliance with the participation requirement at 42 C.F.R. § 483.20(b).

F-Tag 279

Under F-Tag 279, CMS determined that Northern Montana was not in substantial compliance with provisions of 42 C.F.R. § 483.20(d) as in effect at the time of the April 1998 survey, requiring that facilities develop a comprehensive care plan for each resident. As in effect at the time of the survey, that regulation, titled "resident assessment" (now at section 483.20(k)) stated that:

(d) Comprehensive care plans. (1) The facility must develop a comprehensive care plan for each resident that includes measurable objectives and timetables to meet a resident's medical, nursing, and mental and psychosocial needs that are identified in the comprehensive assessment. The care plan must describe the following--
(i) The services that are to be furnished to attain or maintain the resident's highest practicable physical, mental, and psychosocial well-being as required under § 483.25; and
(ii) Any services that would otherwise be required under § 483.25 but are not provided due to the resident's exercise of rights under § 483.10, including the right to refuse treatment under § 483.10(b)(4).
(2) A comprehensive care plan must be--
(i) Developed within 7 days after completion of the comprehensive assessment;
(ii) Prepared by an interdisciplinary team, that includes the attending physician, a registered nurse with responsibility for the resident, and other appropriate staff in disciplines as determined by the resident's needs, and, to the extent practicable, the participation of the resident, the resident's family or the resident's legal representative; and
(iii) Periodically reviewed and revised by a team of qualified persons after each assessment.
(3) The services provided or arranged by the facility must--
(i) Meet professional standards of quality; and
(ii) Be provided by qualified persons in accordance with each resident's written plan of care.

56 Fed. Reg. 48,871 (Sept. 26, 1991), as amended at 57 Fed. Reg. 43,924 (Sept. 23, 1992).

Under this deficiency tag, CMS found that Northern Montana failed to develop comprehensive care plans for 21 residents. The ALJ upheld CMS's deficiency finding under this tag after analyzing the findings for three of them, residents 28, 6, and 17. FFCL No. 2, ALJ Decision at 10.

Resident 28

The essence of the 2567 is that the resident had no care plan to address problem behaviors including wandering, even though the resident was observed on all days of the survey to exhibit problem behaviors, and the comprehensive care plan stated that the resident exhibited daily problem behaviors. CMS Ex. 1, at 28. Before the ALJ, CMS argued that resident 28 wandered and had daily behavioral problems, but that the care plan did not specifically address or provide interventions concerning the resident's disruptive behaviors. ALJ Decision at 11, citing CMS Ex. 30, at 38-40. The ALJ found that the care plan supported CMS's allegations, and that Northern Montana did not rebut CMS's evidence and argument. Id.

On appeal, Northern Montana argued that CMS failed to establish a prima facie case that Northern Montana was not in substantial compliance with the regulation, and objected to this deficiency to the extent that CMS produced no findings or evidence on the 2567, or produced such evidence only in preparation for or in testimony at the hearing. Northern Montana Request for Review at 19. Northern Montana also argued that the resident's behaviors were not so problematic that they required the development of a care plan. Northern Montana cited testimony of its staff that the resident's behaviors had been allayed by placing her in a quieter setting and thus did not need to be further addressed.

First, we reject Northern Montana's attack on CMS's ability to rely on evidence beyond the 2567 to establish its case. CMS's prima facie case is not limited to the findings and statements in the form 2567, and may include surveyor's confirmatory testimony about information in the 2567. Omni Manor Nursing Home, DAB No. 1920, at 16-18 (2004). The statement of deficiencies does not rigidly frame the scope of evidence to be admitted concerning any allegation relating to a cited deficiency, nor does it require formal amendment to allow additional supporting evidence. The 2567 is a notice document, and is not designed to lay out every single detail in support of a finding that a violation has been committed. Pacific Regency Arvin, DAB No. 1823, at 9-10 (2002). The Board has further held that the ALJ may rely on a clarifying declaration submitted by a surveyor explicating the findings in the 2567, and may draw reasonable inferences from the statement of deficiencies. Regency Gardens Nursing Center, DAB No. 1858, at 15-17 (2002).

We also reject Northern Montana's contention that the 2567 did not make out a prima facie case for this resident. The 2567 repeated the requirements of the regulation, and stated that Northern Montana did not meet those requirements because it failed to develop comprehensive care plans for specified residents as its care plans did not adequately reflect the care needs of the residents and did not have specific and measurable goals and specific approaches for chronic issues, did not identify problems through assessments, and did not identify responsibilities for who was to follow through with approaches. CMS Ex. 1 at 27-28.

Next, we find that substantial evidence supported the ALJ's finding of a deficiency for this resident. The MDS for the resident states that she experienced persistent anger with self or others, as well as verbally abusive behavioral symptoms. CMS Ex. 30, at 5. The weekly profile reflects that she had occasional outbursts of anger at noisy residents. CMS Ex. 30, at 33-35. The testimony of Northern Montana's witness, Alice Chambers, confirms that the resident experienced agitation and anxiety, and had outbursts at other residents who made noise. Tr. at 462-63. A notation from July 1998 states that the resident remained extremely demented. Northern Montana Ex. 28, at 53. Northern Montana entered into evidence a care plan for resident 28 for "Cognitive loss/Dementia," which does not address any of these behaviors or her wandering. Northern Montana Ex. 28, at 14. If these behaviors were indeed easily alterable, as Northern Montana's witness testified, then this facet of her treatment could have been noted in her plan of care. Tr. at 462-63. Although Northern Montana cited the testimony of one of its witnesses, a physician, as establishing that the resident's type of wandering did not need to be addressed (as it was harmless so long as the resident was kept in a unit with a circular corridor that would give her the impression of progress), the physician's testimony on this point did not specifically address this resident or establish that this was the extent of her problem behaviors. For the benefit of this resident, as well as the benefit of any staff who were not personally familiar with her but may have been called upon to treat her, the care plan should have reflected the strategies that Northern Montana devised to address her problem behaviors.

Resident 17

The CMS 2567 states that resident 17 had daily behavioral problems, as observed on all days of the survey and as shown by the resident's comprehensive assessment, was assessed on all MDSs to have long and short term memory problems and to be severely impaired in decision making, and had a care plan with a goal of maintaining optimal cognitive functions. However, the 2567 alleges that the care plan had no approaches on how to address the resident's problem behaviors. CMS Ex. 1, at 26-28. CMS also determined that while the MDS showed that the resident was totally incontinent, the resident's care plan had a goal noting that the incontinent episodes will be under control; however, CMS found that care plans cited under this deficiency tag failed to contain specific and measurable goals, and specific approaches for chronic issues. Id.

The ALJ, citing the 2567, hearing testimony, and the resident's records, found that the resident's care plan was devoid of specific interventions to give staff specific and measurable goals and approaches to guide them in the care of this resident, and that there was nothing in the care plan offering any specific, concrete intervention for maintaining optimal cognitive functioning, or a clear, measurable plan or intervention to deal with the resident's incontinence. ALJ Decision at 13.

Before the Board, Northern Montana disputed the ALJ's findings on the grounds that its care plan for this resident "included specific interventions for her anxiety and anger as well as the need for a consistent caregiver." Northern Montana Request for Review at 23. Northern Montana also argued that the CMS RAI manual permits an interdisciplinary team to combine related issues into a single care plan problem. Id., citing Northern Montana Ex. 52, at 283. This is true, but does not undercut the ALJ's findings here. Even if the cited interventions were relevant to address the resident's behavior problems, as well as her anger, Northern Montana did not explain how they would constitute interventions to help the resident maintain her optimal cognitive functions, or to address her incontinence. Moreover, the interdisciplinary team here did not in fact combine the issues in the care plan, but instead treated them as separate problems. Northern Montana Ex. 17, at 52.

Northern Montana also argued that the ALJ misunderstood its argument with respect to this resident. Northern Montana argued that the ALJ failed to understand the subtleties of the MDS coding process, and thus failed to grasp that (for example) a decrease in cognitive function would be shown by comparing the coding from one MDS to the next. Northern Montana also argued that CMS failed to provide a full and complete citation of the deficiency and that the 2567 provided no clear indication of what the deficient practice was for this resident, as it "only states that the care plan included two goals for cognitive function and incontinence." Request for Review at 23.

Northern Montana's claim of ignorance as to the specific nature of the deficiency cited for this resident is not credible. The 2567's statement that the care plan for this resident included two goals for cognitive function and incontinence must be read in the context of its overarching statement for this deficiency, which stated that (among other things) the care plans for this and other residents did not contain specific and measurable goals or approaches for chronic issues, identify problems through assessments, or document who was responsible to follow through with approaches, as well as its recitation of the regulation's requirements that the care plan include measurable objectives and timetables to meet a resident's medical, nursing, and mental and psychosocial needs that are identified in the comprehensive assessment. CMS Ex. 1, at 26-28. When read in its entirety, the 2567 adequately informed Northern Montana of the nature of the findings regarding this resident.

Northern Montana's argument regarding the alleged uncertainties of the MDS coding process supports only its contention that its comprehensive assessment for this resident would have reflected any decline in her function, and does not address other deficiencies in her care plan noted above. Thus, even if we accepted Northern Montana's argument on this point, that would not provide a basis to reverse the deficiency finding.

Resident 6

The CMS 2567 states that resident 6 had been screened by physical therapy on March 10, 1998, due to a flexion contracture of the hip, and that specific approaches, including passive stretching of hips and knees, were indicated, but were not on the resident's plan of care. CMS Ex. 1, at 28.

The ALJ noted that the physical therapy suggestions included that the resident sleep supine and nap during the day, use a wheelchair harness across the upper chest to prevent forward flexion, receive passive stretches to strengthen hips and knees, and be walked while being reminded to stand straight. The ALJ agreed with surveyor testimony that it was important to document the physical therapy recommendations in the plan so that facility staff could know what to do to prevent a problem from worsening. The ALJ thus rejected Northern Montana's argument that it did not have to follow the physical therapy suggestions and that it rejected some of the suggestions as being inappropriate for the resident, finding that Northern Montana had failed to document that decision. The ALJ also rejected Northern Montana's assertion that it incorporated some of the suggestions into the care plan, and found, based on his review, that the care plan did not contain any updates encompassing the physical therapy recommendations. ALJ Decision at 12.

Before the Board, Northern Montana did not dispute the ALJ's finding that it did not update the resident's plan subsequent to the physical therapy evaluation and that it thus did not include at least some of the physical therapy suggestions into the care plan, and that the care plan did not document any decision that some of the suggestions were inappropriate for the resident. Instead, Northern Montana argued that there was no difference between one of the physical therapy suggestions regarding ambulation, and a restorative ambulation program that was already in place for the resident. Northern Montana cited nurses' notes and flow sheets prepared by certified nursing assistants as documenting that ambulation was either provided or offered to the resident. Northern Montana also argued that the physical therapy recommendations would not have prevented the resident's problem with flexion and decreased range of motion, because these were the result of the progression of her Alzheimer's disease.

Northern Montana's argument that the resident was unlikely to benefit from the some of the recommendations misses the point of this deficiency finding, which is based on a failure of documentation, not a failure to provide services. The regulation in question requires that the care plan describe the services that are to be furnished in order to attain or maintain the resident's highest practicable physical well-being. Northern Montana did not dispute that a physical therapy evaluation provided recommendations or suggestions that were aimed at alleviating a flexion contracture of the resident's hip. Northern Montana's decision not to implement those recommendations, whether reasonable or not, was of little value if not documented in the plan of care or elsewhere. Northern Montana also provided no evidence that it considered and rejected the physical therapist's recommendations.

Accordingly, we sustain the ALJ's FFCL No. 2, that as of the survey ending on April 30, 1998, Northern Montana was out of compliance with the participation requirement at 42 C.F.R. § 483.20(d) (F-Tag 279).

F-Tag 323

Under the heading F-Tag 323, CMS determined that Northern Montana was out of compliance with the participation requirement at 42 C.F.R. § 483.25(h)(1). As in effect currently and at the time of the survey, that regulation requires a facility to ensure that the resident environment remains as free of accident hazards as is possible.

Under this deficiency tag, CMS made findings concerning risks to residents posed by a vacuum cleaner hose, and by an unlocked door to a facility beauty shop where caustic products were stored. We find no basis to disturb the ALJ's conclusions that Northern Montana was not in substantial compliance with the regulation.

Regarding the vacuum hose, the CMS 2567 indicates that the facility employed a central vacuuming system with a long hose that attached to a wall. On two successive days surveyors observed the system in use with the hose lying in the corridor and the operator in a room, in areas of the facility where residents of unsteady gait wander or ambulate independently. The report describes an excessive amount of hose in or flopping in the corridor on the first day; on the second day the hose was seen on the corridor floor in what the report describes as a looping fashion, the staff person doing the vacuuming was in a resident room with his or her back to the door, and the surveyor almost tripped on the hose in the corridor as the staff person doing the vacuuming pulled it farther into the room. CMS Ex. 1, at 43-44.

The ALJ found that a vacuum hose moving about a hall could cause a risk of more than minimal harm to the facility's elderly and, he observed, perhaps demented and unsteady residents. He found that Northern Montana failed to submit evidence regarding what measures it put into place to maintain a safe environment while vacuuming, and that Northern Montana instead questioned the surveyors' documentation. FFCL No. 3; ALJ Decision at 14-15, citing Tr. 398, 658-59.

On appeal, Northern Montana again disputed the surveyors' findings and observations regarding the vacuum cleaner hose, characterizing the surveyors' descriptions of the hose as becoming increasingly vivid as the case progressed. However, the ALJ noted Northern Montana's objections to the surveyors' findings and testimony, but found that their testimony was consistent in their observation that the vacuum might cause a tripping hazard. Absent clear error, we defer to the findings of the ALJ on weight and credibility of testimony. Batavia Nursing and Convalescent Center, DAB No. 1904 (2004), at 27; Koester Pavilion, DAB No. 1750, at 15, 21 (2000). Here, as in Koester Pavilion, "[w]e find no compelling reason to reject the ALJ's determination about the relative credibility and persuasiveness of the testimony of these witnesses." Id. at 24.

Northern Montana also disputed the ALJ's finding that it failed to submit evidence of the measures it took to maintain a safe environment while vacuuming was in progress. Northern Montana cited an undated memorandum from its environmental services manager stating that vacuuming is done when residents are out of their rooms and halls, to prevent someone from falling on a hose, and a statement of its Director of Nursing that cleaning is scheduled as much as possible for when residents are not in their rooms or the hallways. Northern Montana Exs. 23, at 13; 56, at 3. However, the ALJ could reasonably discount the testimony that Northern Montana presented at the hearing about its policy of not vacuuming while residents were about, as one of the surveyors testified that there were residents in the hallway while the vacuum hose was deployed, and the survey report and the surveyors' testimony indicate that the vacuum operator could not observe residents in the corridor while vacuuming inside a resident's room. CMS Ex. 1, at 43-44; Tr. at 266-67, 384-85, 398, 658-59. Northern Montana failed to demonstrate that it implemented its policy of vacuuming at times when residents were not nearby, that this policy would be effective to safeguard residents, or that it took measures to prevent those residents who despite the policy might be in the corridor during vacuuming of rooms (when they were not always visible to the vacuum operator) from the risk of tripping over the hose.

As to the unlocked beauty shop, the CMS 2567 indicates that on April 29, 1998, during rounds between 6:30 and 8:00 pm, surveyors found the door to the beauty shop open with caustic products left out, including, on the bottom shelf of an unlocked metal closet, two full bottles and a partial bottle of a disinfectant called Mar-V-Cide. The label of this product described it as a hazard to humans and domestic animals, as corrosive, as capable of causing eye and skin damage, and as harmful or fatal if swallowed. The 2567 also notes that a large variety of hair care products were accessible to residents, that the facility's beauty shop guidelines state that the door is to be locked, and that an interview with staff demonstrated that the door is occasionally left open as family sometimes wish to provide hair care for individual residents. CMS Ex. 1, at 44 - 45.

The ALJ rejected Northern Montana's argument that this was an isolated, single incident that did not rise to the level of failing to comply substantially with the regulation, as well as Northern Montana's effort to discount as hearsay the statement in the 2567, and in a surveyor's testimony, that facility staff had stated in an interview that the beauty shop door was occasionally left open, despite the facility's guidelines. The ALJ noted that hearsay testimony is admissible in an administrative hearing, and found that Northern Montana provided no basis not to credit the surveyors' testimony, and no evidence to dispute their observations that a potentially dangerous substance was left out in an unlocked room accessible to facility residents who might not understand that the substance was a danger to them. The ALJ also rejected Northern Montana's point that there were two doors to the beauty shop, one that opened into an area not immediately accessible to residents, and that the surveyors' report and work papers did not indicate which door was unlocked; the ALJ noted that the exhibit Northern Montana cited did not support its claim. The ALJ thus found that this was more than an isolated incident, and characterized it as an accident waiting to happen. ALJ Decision at 15-16.

On appeal, Northern Montana again characterized the unlocked door as a single, isolated incident, and again argued that the surveyors failed to indicate which of the beauty shop's two doors was unlocked, citing a floor plan as evidence of two doors. (In its Post-Hearing Brief before the ALJ, Northern Montana apparently cited the wrong exhibit, an error that it characterized as typographical. Northern Montana Post-Hearing Br. at 65; Request for Review at 26.)

Northern Montana has provided no reason to reverse the ALJ's determination. That Northern Montana guided the ALJ to an incorrect exhibit to establish that there were two doors to the beauty shop is irrelevant, in light of surveyor reports and testimony that the outside door to the beauty shop was seen unlocked and open, that the beauty shop was accessible to residents, and that facility staff had reported that the door was sometimes left unlocked to permit ingress by family members. CMS Ex. 1, at 44-45; Tr. 399-400, 657. The ALJ credited this testimony, and we have no grounds to disturb that decision. Petitioner did not cross-examine the surveyors regarding the different doors to the beauty shop. The Board has previously upheld a deficiency finding under this regulation on similar facts, i.e., an unlocked storage area containing cleansers and disinfectants in an area where residents were seen, even though no accident occurred. Omni Manor. We have no basis to find differently here. We thus agree that by leaving the beauty shop door unlocked, Northern Montana failed to ensure that the resident environment remained as free of accident hazards as is possible.

Northern Montana also argued generally under this deficiency that CMS applied an incorrect or substantially revised standard in assessing this deficiency, because the 2567 states that Northern Montana failed to ensure that the resident environment remained free from potential hazards, whereas the regulation requires that the resident environment remain free from accident hazards. However, the 2567 also cited the correct text of the regulation, and the ALJ applied that standard in his decision. We thus sustain FFCL No. 3, that Northern Montana was out of substantial compliance with the participation requirement at 42 C.F.R. § 483.25(h)(1).

F-Tag 333

In a deficiency finding cited as F-Tag 333, CMS determined that Northern Montana failed to comply substantially with the requirement of 42 C.F.R. § 483.25(m)(2), as in effect currently and at the time of the survey, that a facility must ensure that residents are "free of any significant medication errors." The deficiency finding was based on a surveyor's observation that a nurse administered a smaller dose of insulin to resident 40 than ordered by the resident's physician, and centered on the technique that the nurse employed to fill a hypodermic syringe. According to the CMS 2567, the nurse, based on a prior observation, would, while in the medication room, pull back the plunger or piston of the syringe to draw the correct dose into the syringe, pull back farther to admit a bubble of air, proceed to the resident's room, push the plunger back in to the marking for the correct dose, expelling the bubble of air, and then administer the correct dose. The 2567 further reports that on April 29, 1998, at 7:30 a.m., when the nurse pushed out the bubble of air prior to administering the injection, she pushed the plunger beyond the marking for the correct 14-unit dose to the marking for a 12-unit dose, so that the resident received 12 units instead of the 14 units ordered by the resident's physician. The surveyor reported this error to the nursing supervisor. CMS Ex. 1, at 54-55. The 2567 also states that sites of administration were not routinely documented following injections, and that doing so would allow for proper rotation of sites for routine injections. Id.

At the hearing, the surveyor testified that the injection technique she observed was not a proper administration, and that residents generally get their main dose of insulin in the morning, so it is generally very dangerous if patients do not get the proper dosage of insulin in the morning. ALJ Decision at 17, citing Tr. at 284-85.

Before the ALJ, Northern Montana argued that the surveyor could not have accurately observed the under-administration of two units of insulin, and that the reported error was not significant in any event. Northern Montana cited an affidavit from the resident's attending physician stating that a two-unit deviation would not be a significant drug error for the resident. ALJ Decision at 17, citing Northern Montana Ex. 57.

The ALJ found that Northern Montana's attack on the surveyor's determination, including a demonstration utilizing a syringe that Northern Montana conducted during the hearing, failed to convince him that the surveyor's testimony was not credible. The ALJ also found that Northern Montana's argument about the effect of the under-administration of insulin on resident 40 did not allay his concern that the nurse's technique for administering an injection could have caused more than minimal harm to other residents. Finally, the ALJ found that Northern Montana failed to address the observation in the 2567 that Northern Montana failed to routinely document the sites of medication administration following injections, and that the failure to do so could result in improper rotation of sites for routine injections.

On appeal, Northern Montana again did not concede that the under-administration of medication occurred, and disputed the ALJ's conclusion that the observed two-unit under-administration of insulin was a significant medication error for the purposes of the regulation. However, Northern Montana failed to cite any specific factual error in the ALJ's finding that the two-unit under-administration of insulin occurred, or to provide any basis to find that the ALJ's finding was not based on substantial evidence. Absent clear error, we defer to the findings of the ALJ on weight and credibility of testimony. Batavia, DAB No. 1904, at 27; Koester Pavilion at 15, 21. Here again, as in those cases, we find no compelling reason to reject the ALJ's determination about the relative credibility and persuasiveness of the surveyor's testimony. Accordingly, we conclude that the ALJ's finding that Northern Montana administered an incorrect dose of insulin to resident 40 was supported by substantial evidence, as was the unrebutted finding that Northern Montana failed to routinely document the sites of medication administration following injections.

Having found that the ALJ's factual findings were supported by substantial evidence, we turn to his conclusion that Northern Montana committed a significant medication error for the purposes of the regulation. The ALJ did not state that the under-administration of insulin to the resident that the surveyor observed was a significant medication error under the regulation. The ALJ made no findings concerning the affidavit opinion of the resident's attending physician that the two-unit under-administration of insulin would not be a significant drug error for this resident, and provided no reason to reject that opinion. Instead, the ALJ based his finding that there was a deficiency under section 483.25(m)(2) on his concern that the technique that the nurse used in administering the injection could have caused more than minimal harm to other residents, and on the nurse's unrebutted failure to record injection sites.

However, the applicable legal authority, consisting of CMS's program issuances and the preamble to the regulation at issue and to an analogous regulation, indicate that the finding of a significant medication error must be based on a specific error with respect to a specific resident, and not on the mere potential for errors with respect to other residents. The preamble to 42 C.F.R. § 483.25(m) states:

Since medication errors vary in their significance (e.g., from significant errors such as a double dose of a potent cardiac drug like digoxin to a small error in the dose of an antacid like milk of magnesia), we have based sanctions on two different criteria. First, if a facility has a significant medication error, then it is sanctioned. . . . A significant medication error is judged by a surveyor, using factors which have been described in interpretive guidelines since May 1984. The three factors are: (1) Drug category. Did the error involve a drug that could result in serious consequences for the resident (2) Resident condition. Was the resident compromised in such a way that he or she could not easily recover from the error (3) Frequency of error. Is there any evidence that the error occurred more than once[?] Using these criteria, an example of a significant medication error might be as follows: A resident received twice the correct dose of digoxin, a potentially toxic drug. The resident already had a slow pulse rate, which the drug would further lower. The error occurred three times last week.

56 Fed. Reg. 48,853 (Sept. 26, 1991) (emphasis added).

Under this longstanding interpretation, a finding of a significant medication error reflects the effect of an actual medication error on a specific resident, rather than the potential for a medication error with respect to other, unspecified residents. This interpretation is consistent with later CMS issuances concerning significant medication errors in other contexts. In its preamble to proposed rules for hospitals participating in the Medicare and Medicaid programs, CMS stated:

Significant medication errors are defined as errors that jeopardize or cause serious potential for jeopardizing the health and safety of the patient. HCFA has used this concept for many years in long-term care facilities, and has considerable experience at defining what would constitute a significant medication error.

62 Fed. Reg. 66,738 (Dec. 19, 1997) (emphasis added).

Consistent with this preamble language, the CMS SOM indicates that a finding of a significant medication error is to be based on the occurrence of an actual medication error with respect to a specific resident:

VI. SIGNIFICANT AND NON-SIGNIFICANT MEDICATION ERRORS

A. General Rules for Determining Significance.-- The relative significance of medication errors is a matter of professional judgement. Surveyors who are responsible for assessing these requirements must be qualified to exercise such judgement (e.g., pharmacists, nurses). Follow three general rules in determining whether a medication error is significant or not:

l. Patient Condition.-- The patient's condition is an important factor to consider. For example, a potent diuretic erroneously administered to a dehydrated patient may have serious consequences but if administered to a patient with a normal fluid balance may not. If the patient's condition requires rigid control, a single missed or wrong dose can be highly significant.

2. Drug Category.-- If the drug is from a category that usually requires the patient to be titrated to a specific blood level, a single medication error could alter that level and precipitate a reoccurrence of symptoms or toxicity. This is especially true if the half life of the drug is short. Examples of drug categories which require titration of patient blood levels include anticonvulsants, anticoagulants, and antiarrhythmic, antianginal and antiglaucoma agents.

3. Frequency of Error.-- If an error is occurring with any frequency, there is more reason to classify the error as significant. For example, if a patient's drug was omitted several times, as verified by reconciling the number of tablets delivered with the number administered, classifying that error as significant would be in order. This conclusion may be especially valid when taken in concert with the patient's condition and the drug category.

SOM, APP. N, Surveyor Procedures for Pharmaceutical Service Requirements in Long-Term Care Facilities, Part Two, Methodology for detecting medication errors.

Under these various, consistent standards, the potential that the nurse who under-administered insulin to resident 40 might commit a similar error with other, unspecified residents does not support the conclusion that the facility committed a significant medication error, where the observed medication error has not been found to be significant. As noted above, the ALJ did not conclude that the two-unit under-administration of medication that the surveyor observed was significant, but instead based his finding of a deficiency on the potential for errors with respect to other residents. Similarly, the criteria specified in these issuances provide no basis to conclude that the failure to record sites of injections rises to the level of a significant medication error. We do not conclude here that Northern Montana did not commit medication errors in under-administering insulin to the resident, or in failing to record the sites of injections. However, CMS's issuances and the evidence before the ALJ provided no basis to conclude that these errors were significant medication errors for the purpose of the regulation.

Accordingly, we conclude that Northern Montana demonstrated that it was in substantial compliance with the requirement that it be free of significant medication errors. We thus modify FFCL No. 4 to read as follows:

As of the survey ending on April 30, 1998, Petitioner was in substantial compliance with the participation requirement at 42 C.F.R. § 483.20(b) (referenced as F Tag 333 on the statement of deficiencies from the April 30, 1998 survey).

Conclusion

For the reasons explained above, we sustain the ALJ's FFCLs Nos. 1-3, and we modify FFCL No. 4 as discussed above. As applicable law authorizes termination of a provider agreement and imposition of a DPNA if a provider is found to be out of substantial compliance with a single program requirement, we sustain FFCL No. 5, imposing the DPNA for the period May 29, 1998 through June 22, 1998. We also sustain the earlier ALJ order striking certain issues.

Judith A. Ballard

Cecilia Sparks Ford

Donald F. Garrett
Presiding Board Member

1. CMS was previously named the Health Care Financing Administration (HCFA). See 66 Fed. Reg. 35,437 (July 5, 2001). We use "CMS" in this decision unless we are quoting documents that refer to HCFA.

2. Section 205(g) provides for judicial review of final hearing decisions of the Commissioner of Social Security. Section 1866(h) of the Act applies that section to provider appeals but states that references to the Commissioner of Social Security or the Social Security Administration in section 205(g) shall be considered references to the Secretary or the Department of Health and Human Services, respectively.

3. We note that there are some circumstances in which the ALJ's failure to address all of the deficiency findings could affect the remedy imposed by CMS and be prejudicial to the facility, such as where CMS relied on the additional deficiency findings in setting the amount of a civil money penalty above the minimum amount required by regulation, or in determining that the facility had not achieved substantial compliance before a certain date. Those circumstances are not present here, as a DPNA is authorized for one or more deficiencies at scope and severity level of D and above, and Northern Montana argued that it had no deficiencies, and not that it had achieved compliance at a date earlier than determined by CMS. Before the Board Northern Montana did not dispute MDPHHS's determination that the deficiencies at issue (including the three that we sustain) were corrected effective June 22, 1998, the end of the period of the DPNA imposed by CMS.

4. In this regard, the sample "full assessment" CMS MDS form found in the CMS RAI manual (MDS 2.0, October 1995) is more comprehensive than the quarterly assessment CMS MDS forms that Northern Montana completed for this resident in January and April 1998 (MDS 2.0, October 1994). Among the "problem conditions" to be noted in section J, "health conditions," the sample MDS form has a space to be checked if the resident has had edema present in the last seven days, whereas the quarterly MDS forms that Northern Montana completed do not. CMS Ex. 30, at 5-6, 30-31; Northern Montana Ex. 52, at 17-22. (As noted above, the allegedly deficient MDS from October 1997 is not part of the record.) CMS did not allege that Northern Montana used an incorrect form in conducting this resident's quarterly assessment.