Skip Navigation

CASE | DECISION | JUDGE | FOOTNOTES

Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Appellate Division
IN THE CASE OF  


SUBJECT: Guardian Health Care Center,

Petitioner,

DATE: August 31, 2004

             - v -
 

Centers for Medicare & Medicaid Services

 

Docket No. A-04-96
Civil Remedies No. C-03-313
Decision No. 1943
DECISION
...TO TOP

REMAND OF
ADMINISTRATIVE LAW JUDGE D
ECISION

On April 29, 2004, Guardian Health Care Center (1) (Guardian) appealed a February 20, 2004 decision by Administrative Law Judge (ALJ) Jose A. Anglada. Guardian Health Care Center, DAB CR1144 (2004) (ALJ Decision). In his decision, the ALJ granted a motion for summary judgment filed by the Centers for Medicare & Medicaid Services (CMS), finding that Guardian was not, as of November 7, 2002, in substantial compliance with the regulation that requires a skilled nursing facility to provide its residents with adequate supervision and assistance devices to prevent accidents. The ALJ also found that Guardian did not come back into substantial compliance with Medicare participation requirements until December 4, 2002, and that CMS was therefore authorized to impose a CMP of between $50 and $3,000 per day from November 7 through December 4, 2002. Finally, the ALJ found that the amount of the CMP imposed by CMS for Guardian's noncompliance -- $500 per day -- was reasonable.

We affirm the ALJ's finding that Guardian was not in substantial compliance beginning on November 7, 2002. We also affirm his finding that the amount of the per day CMP imposed for Guardian's noncompliance -- $500 per day -- is reasonable. However, we find that there is a genuine dispute of material fact concerning the duration of the noncompliance for which the CMP was imposed. Accordingly, we remand the case to the ALJ to resolve that issue and to take any additional appropriate action.

Regulatory Background

As a skilled nursing facility (SNF) that participates in the Medicare program, Guardian must comply with the requirements for participation found in 42 C.F.R. Part 483, subpart B. Compliance with these requirements is verified through surveys performed by state agencies. See 42 C.F.R. Part 488, subpart E. Deficiencies -- a deficiency is a defined as a failure to meet a participation requirement -- that are discovered during a survey are reported by the state survey agency on a standard form called a "Statement of Deficiencies." See 42 C.F.R. §§ 488.325(a) and 488.301; CMS State Operations Manual (SOM), Appendix (App.) P, sec. IV. Each deficiency citation in the Statement of Deficiencies (SOD) is identified by an alpha-numeric "tag" number that corresponds to a specific participation requirement in 42 C.F.R. Part 483, subpart B. See SOM, App. P, sec. IV. The SOD also summarizes the facts and evidence supporting each citation. Id.

If a survey reveals that a facility is not in "substantial compliance" with one or more participation requirements, CMS may impose a CMP or other remedy to encourage the facility to bring itself into substantial compliance promptly. See 42 C.F.R. §§ 488.404, 488.406, 488.408, and 488.440. "Substantial compliance" means a level of compliance such that "any identified deficiencies pose no greater risk to resident health or safety than the potential for causing minimal harm." 42 C.F.R. § 488.301.

A facility may appeal a finding of noncompliance that supports the remedy or remedies imposed by CMS by requesting a hearing before an ALJ. 42 C.F.R. § 498.3(b)(13). ("Noncompliance" is defined in 42 C.F.R. § 488.301 to mean "any deficiency that causes a facility to not be in substantial compliance.") In addition to challenging CMS's finding of noncompliance, the facility may also contend on appeal that the amount of a CMP imposed is unreasonable. Capitol Hill Community Rehabilitation and Specialty Care Center, DAB No. 1629 (1997). In evaluating whether the amount of the CMP is reasonable, an ALJ may consider only the factors specified in 42 C.F.R. § 488.438(f). 42 C.F.R. § 488.438(e)(3).

Case Background

The Ohio Department of Health (ODH) completed a survey of Guardian on November 7, 2002. Guardian Ex. 2, at 12. The Statement of Deficiencies (SOD) for this survey cited deficiencies under several tag numbers. CMS Ex. 1. Under tag F324, ODH reported that Guardian was out of compliance with 42 C.F.R. § 483.25(h)(2), which requires a facility to "ensure" that "each resident receives adequate supervision and assistance devices to prevent accidents." Id. at 21. In support of this deficiency citation, the SOD sets out, in the "summary statement" section, ODH's factual findings concerning three residents -- Residents 44, 37, and 19. The following is a partial summary of those findings, which, according to the SOD, were based on interviews with facility staff and resident family members, review of resident medical records, and observations by the ODH surveyors:

  • Resident 44 had Parkinson's disease, dementia, and other conditions. He was fully dependent on others to help him perform daily activities, such as bathing. He was judged by the facility to be at risk for falls. He had fallen on April 16, May 22, and June 29, 2002. On July 17, 2002, a licensed practical nurse (LPN) was helping him to bathe. (2) He was sitting on the side of his bed. When he requested privacy so that he could bathe his genital area, the LPN pulled the nearby curtain, told him not to stand, and then left him unsupervised. Less than two minutes later, the LPN heard the resident fall and found him lying on the floor. After complaining of hip pain, he was taken to the hospital and found to have a hip fracture.


  • Resident 37 had a diagnosis of dementia and was identified as being at high risk for falls. His assessment (reflected in his Minimum Data Set) indicated that he required the supervision of one person for toilet use. On May 18, June 3, August 4, and August 10, 2002, Resident 37 was found on the floor near his bed or near the bathroom. On May 18, he was found on the floor in front of the bathroom. On June 3, he was found lying on the floor next to his bed. On August 4, he urinated on the floor and slipped while attempting to get to the bathroom. After this fall, the facility placed a commode next to his bed. Then, on August 10, Resident 37 slipped to the floor while walking to the bathroom. He had voided a large amount of urine while walking. After the fall, it was determined that he had a sustained a fractured right hip.


  • Resident 19 was found to be at risk for falls. His comprehensive assessment indicated that he needed extensive assistance to perform various activities of daily living, and that his behavior included daily wandering and social inappropriateness, as well as occasional (once to three times per week) resistance to care. On October 20, 2002, he was found sitting on the floor in the activity dining room with an injury to his right elbow. He had been sitting in a straight-back chair. Six to eight residents, but no staff members, were in the room when this incident occurred. The facility's quality assurance nurse and social service director were interviewed about the incident. They revealed that Resident 19 had been brought into the dining room that day, removed from his wheelchair (which had a lap buddy), placed in a regular chair, and left unattended. He then fell from the chair and sustained the elbow injury. A few days after the incident, the facility modified Resident 19's plan of care to require that he be placed in a "geriatric chair with tray." The facility also decided to evaluate Resident 19's behavior due to his "uncooperative attitude." On November 7, 2002, surveyors observed Resident 19 in the activity dining room, seated in a straight-back chair at a dining room table. His geriatric chair was against the wall. Ten other residents were in the room, and no staff were present. A surveyor observed Resident 19 sit at the table unsupervised and unattended for five minutes.

Based on these and other facts, the SOD states that: (1) Guardian "failed to provide supervision to prevent the fall which resulted in [Resident 44's hip] fracture" on July 17, 2002 (CMS Ex. 1, at 23); (2) there was "no evidence that the facility implemented any effective interventions to prevent" the falls relating to Resident 37's incontinence (id. at 24); and (3) the facility failed to provide "appropriate supervision" of Residents 44 and 19 (id. at 21).

In a letter dated December 12, 2002, CMS informed Guardian that it was not in substantial compliance, as determined during the November survey, and its most serious deficiency was the alleged failure to comply with section 483.25(h)(2). See Guardian Ex. 2, at 12. The December 12 notice letter also informed Guardian that CMS had accepted ODH's recommendation to impose various enforcement remedies, including a $500 per day CMP effective November 7, 2002, a prohibition on nurse aide training, and a denial of payment for new admissions (DPNA) effective February 7, 2003. Id. at 12-13.

On December 5, 2002, a week before CMS notified Guardian of these remedies, ODH conducted a revisit survey and found that Guardian continued to be in noncompliance but that the remaining uncorrected deficiencies were not as serious as the ones that had been corrected. (3) See CMS Ex. 1, at 28; Guardian Ex. 2, at 19. On December 26, 2002, a "desk audit" found that Guardian had achieved substantial compliance on December 6, 2002. Guardian Ex. 2, at 19. On January 31, 2003, CMS informed Guardian that it had rescinded the DPNA, reduced the CMP from $500 to $50 per day effective December 5, 2002, and discontinued the CMP on December 6, 2002. Id. at 20. CMS also informed Guardian that the total CMP due was $14,050, equal to $500 per day for the 28 days from November 7 through December 4, 2002, plus $50 for December 5, 2002. (4) Id. at 19-20.

Guardian appealed the remedies imposed by filing a request for hearing. The hearing request states in part that Guardian was challenging "the factual conclusions of the surveyors that resulted in the allegations of all cited deficiencies." Request for Hearing at 2. Regarding the deficiency citation under tag F324, the hearing request asserts that Guardian provided "appropriate supervision of Resident #19 and Resident #44" and "had effective interventions in place to prevent further falls from occurring for Resident #37"; that the survey agency performed a "biased" and "careless" review of the facility's actions; that nursing notes and other records "contradict" statements made by the surveyors; that interventions were "change[d] and expanded in an effort to keep the residents under appropriate supervision"; and that the facility took "aggressive/appropriate measures" to reduce the risk or probability of accidents.

After the parties exchanged pre-hearing readiness reports, CMS filed a motion for summary affirmance, requesting that the ALJ sustain the $500 per day CMP for the period November 7 through December 4, 2002 (5) based solely on the facility's alleged noncompliance with 42 C.F.R. § 483.25(h)(2). CMS's motion was supported primarily by the SOD (CMS Ex. 1) and resident medical records (CMS Exs. 7-9).

In a memorandum opposing CMS's motion, Guardian stated that CMS had "done nothing more than offer a prima facie case" and that it was submitting "evidence of equal weight." The evidence that Guardian submitted consists of two exhibits. One exhibit contains copies of Guardian's hearing request and CMS's notice letters. Guardian Ex. 2. The second exhibit is a declaration by Guardian's administrator, Jennifer Connolly. Guardian Ex. 2. Ms. Connolly stated in her declaration that she was present during the relevant surveys and was familiar with the facility's personnel, environment, and practices, as well as with the "care, treatment and services provided to the residents." Id. Ms. Connolly also stated that the SOD's findings were "inaccurate, improper, incomplete, and misrepresent the care and services provided to the residents as more fully detailed and explained in the attached Request for Hearing." Id. In addition, Ms. Connolly stated that she had reviewed the facility's request for hearing and affirmed its contents. Id. Finally, she asserted that the CMP should have stopped accruing on November 14, 2002 because ODH had determined, during the revisit survey, that Guardian was in substantial compliance with section 483.25(h)(2) as of that date. Id.

The ALJ granted CMS's motion, finding that: (1) CMS had made a prima facie showing that Guardian had failed to provide Residents 44, 37, and 19 with adequate supervision or assistance devices to prevent accidents; (2) Guardian's failure to provide these services or items resulted in actual harm to one or more of those residents; and (3) there was no genuine dispute of material fact. ALJ Decision at 6-11. The ALJ also found that Guardian had failed to show that it had corrected its noncompliance prior to December 4, 2002. Id. at 11. Finally, the ALJ determined that the amount of the CMP imposed by CMS was reasonable. Id. at 11-12.

Standard of Review

Whether summary judgment is appropriate is an issue that we address de novo. Lebanon Nursing and Rehabilitation Center, DAB No. 1918 (2004).

Discussion

In Guardian's appeal briefs we discern seven main contentions (some of which we elaborate on later). First, Guardian contended that the ALJ violated the Administrative Procedure Act (APA), 5 U.S.C. § 551 et seq., by placing the burden of proof on the facility to show that it was in substantial compliance with section 483.25(h)(2), and that the Board's allocation of evidentiary burdens was a substantive rule that should have been promulgated by notice and comment rulemaking. Request for Review (RR) Brief at 3, 4-7. Second, Guardian contended that the ALJ misapplied the applicable summary judgment standard by "weighing the limited evidence available . . . and then granting judgment based on a preponderance of that evidence." Id. at 3-4 (emphasis in original). Third, Guardian asserted that the Connolly declaration and request for hearing are sufficient to create a genuine dispute of material fact. Id. at 7-10. Fourth, Guardian contended that CMS's motion was "incomplete and improper" because it was unsupported by affidavits or declarations from persons able to verify the truth of the factual assertions in the SOD and to authenticate CMS's documentary evidence. Id. at 2, 9; Reply Brief at 2-4. Fifth, Guardian suggested that the ALJ may have applied the wrong legal standard in determining that the facility had failed to comply with section 483.25(h)(2). RR Brief at 10-15; Reply Brief at 4. Sixth, Guardian contended that summary judgment was improper because the record as a whole could lead a rational trier of fact to conclude that the facility was in substantial compliance with section 483.25(h)(2). See Reply Brief at 1-2, 4-6. Finally, Guardian contended that unresolved factual issues concerning the reasonableness and duration of the CMP preclude summary judgment. Id. at 7-8.

Before addressing these contentions, we describe the parties' evidentiary burdens and the relevant standards for granting summary judgment. The parties' burdens of proof in a CMP case have been described in several of our prior decisions. See, e.g., Western Care Management Corp., DAB No. 1921 (2004). CMS must at the outset make a prima facie showing of noncompliance. CMS has carried this burden if the undisputed facts, together with evidence concerning facts that the facility has contested, are sufficient to establish that the facility was not in substantial compliance with one or more participation requirements. See Hillman Rehabilitation Center, DAB No. 1663, at 8 (1998) (indicating that a prima facie case consists of "evidence sufficient to support a decision in a party's favor, absent contrary evidence"). If CMS makes a prima facie showing of noncompliance, the burden shifts to the facility to demonstrate, by a preponderance of the evidence, that it was in substantial compliance during the relevant period.

Summary judgment may be entered when the record shows that there is no genuine dispute as to any material fact, and the moving party is entitled to judgment as a matter of law. Lebanon. The party moving for summary judgment bears the initial burden of showing the basis for its motion and identifying the portions of the record that it believes demonstrate the absence of a genuine factual dispute. See Celotex Corp. v. Catrett, 477 U.S. 317, 323 (1986). This burden may be discharged by showing that there is no or insufficient evidence to support a judgment for the non-moving party. Id. at 325. If a moving party carries its initial burden, the non-moving party must "come forward with 'specific facts showing that there is a genuine issue for trial.' " Matsushita Elec. Industrial Co. v. Zenith Radio, 475 U.S. 574, 587 (1986) (quoting Fed. R. Civ. P. 56(e)). To defeat an adequately supported summary judgment motion, the non-moving party may not rely on the denials in its pleadings or briefs, but must furnish evidence of a dispute concerning a material fact -- a fact that, if proven, would affect the outcome of the case under governing law. Id. at 586, n.11; Celotex, 477 U.S. at 322. In deciding a summary judgment motion, a tribunal may not make credibility determinations or weigh conflicting evidence but must instead view the entire record in the light most favorable to the non-moving party, drawing all reasonable inferences from the evidence in that party's favor. Madison Health Care, Inc., DAB No. 1927 (2004).

The evidentiary burdens borne by the parties under the applicable substantive law are a factor in evaluating whether the prerequisites for summary judgment have been met. See Lebanon; Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 255 (1986) (in ruling on a motion for summary judgment, the judge must view the evidence presented through the prism of the substantive evidentiary burdens). Thus, if CMS makes a prima facie showing of noncompliance -- based on either uncontested facts, or on a combination of uncontested facts and evidence concerning contested facts -- the facility can avoid summary judgment only if it proffers competent evidence of a genuine factual dispute or demonstrates that the record, viewed in the light most favorable to the facility, might lead a rational trier of fact to conclude that the facility was in substantial compliance. See Lebanon at 5. (6)

With these criteria and principles in mind, we address each of Guardian's contentions in the sections below.

1. There was no error in the assignment of the burden of proof.

We reject Guardian's contention that the ALJ committed an error of law in placing the burden of proof on the facility to show that it was in substantial compliance. The ALJ in fact made no statement whatsoever about the facility's burden of proof. He considered only whether CMS had made a prima facie showing of noncompliance and whether Guardian had created a genuine dispute of material fact.

In any event, we reject Guardian's contention that placing the ultimate burden of persuasion on the facility to show substantial compliance violates the APA. We have considered and rejected this contention in several prior decisions, and we see no reason to revisit it here. See Omni Manor Nursing Home, DAB No. 1920 (2004); Batavia Nursing and Convalescent Center, DAB No. 1904, at 8-21, 24-27 (2004); Batavia Nursing and Convalescent Inn, DAB No. 1911, at 8-22, 24-27 (2004); Tri-County Extended Care Center, DAB No. 1936 (2002).

2. The ALJ did not misapply or fail to apply the proper summary judgment standard.

Guardian contended that the ALJ misapplied or failed to apply the relevant summary judgment standard. Guardian took particular exception to the following passage in the ALJ Decision:

Where a Petitioner raises a factual dispute, an ALJ determines whether the facts are material by resolving all factual disputes in favor of the non-moving party (here, Petitioner). If after the ALJ has resolved all of the factual disputes in favor of Petitioner, and nevertheless finds that CMS has established lack of substantial compliance justifying the penalties imposed, the disputed facts are not material and CMS is entitled to summary judgment. [ALJ Decision at 8 (emphasis added)]

See RR Brief at 3. According to Guardian, the underlined statement is "tantamount to an admission of weighing the factual disputes presented." Id.

Because we determine de novo whether the grant of summary judgment is proper, it is not essential that we discuss whether the ALJ correctly understood and applied the relevant standard. Madison Health Care, Inc. Nevertheless, we find that the ALJ did not misapply or misconstrue the standard. The ALJ determined that CMS was entitled to summary judgment because Guardian had conceded that CMS had made a prima facie showing of noncompliance but then failed to offer evidence creating a genuine dispute of material fact and supporting its contention that CMS was not entitled to judgment as a matter of law. See ALJ Decision at 8-9. Although the ALJ in spots used language suggesting that his conclusions were based on the weight of the evidence, this does not necessarily mean that he improperly weighed the evidence to resolve disputed facts. Having found that there were no disputes about the underlying material facts (ALJ Decision at 8-9), it appears that the ALJ simply determined that no rational trier of fact could, viewing all the facts and evidence in the light most favorable to the non-moving party, conclude that Guardian was in substantial compliance with the regulation requiring it to provide "adequate" supervision and assistance devices. A dispute over the conclusion to be drawn from applying relevant legal criteria to undisputed facts does not preclude summary judgment if the record is sufficiently developed and there is only one reasonable conclusion that can be drawn from those facts. Vandalia Park, DAB No. 1939 (2004).

    3. There is no genuine dispute of material fact.

In its motion for summary affirmance, CMS presented a statement of what it believed were the undisputed material facts of the case. This statement was based on the underlying or background facts reported in the SOD concerning Residents 44, 37, and 19, a portion of which we summarized above. CMS also submitted resident medical records that independently confirm many of the SOD's factual assertions.

In response to CMS's motion, Guardian conceded that CMS had made a prima facie showing of noncompliance and said nothing about CMS's statement of undisputed material facts. See Memorandum in Opposition to Motion for Summary Affirmance, at 1. Jennifer Connolly, Guardian's administrator, stated in her declaration that the "findings" in the SOD were "inaccurate, improper, incomplete, and misrepresent the care and services provided to the residents," but she cited no examples and failed to identify whether the findings she referred to were the SOD's findings regarding the underlying facts, or the broader (or ultimate) findings made by the survey agency based on those facts (e.g., its conclusion that Guardian failed to provide "appropriate supervision" to Residents 44 and 19).

Guardian's hearing request, whose contents Ms. Connelly "affirmed," is likewise vague about what facts were being contested. The hearing request states, for example, that surveyors "ignored" facts and performed a "careless review" but does not specify the facts ignored or indicate how or why the survey was "careless." The hearing request also states that information contained in resident medical records and other documents "contradicts the statements made by the surveyors." The request does not, however, say which "statements" or facts are implicated by the contradictory evidence, or what that contradictory evidence is. The hearing request states that Guardian had "effective interventions in place to prevent further falls from occurring for Resident #37." Again, the hearing request is unspecific: it does not identify the interventions in place or the facts that might support a conclusion that those interventions were "effective." (7) The SOD and medical records submitted by CMS do describe measures taken by the facility to prevent accidents, and of course these measures must (and will) be considered in deciding whether the facility satisfied the regulatory requirement that each resident receive "adequate" supervision and assistance devices. The hearing request does not, however, indicate that the facility took measures in addition to those mentioned in CMS's documents. Nor does the request explain how those documents paint a factually incomplete, inaccurate, or misleading picture of the facility's efforts to protect the three residents from accidental injury.

In light of these circumstances, we conclude that there is no genuine dispute as to any material fact requiring a hearing. In its motion for summary affirmance, CMS identified certain facts as undisputed and introduced competent evidence of those facts (the SOD and resident medical records). In response, Guardian failed to identify, with specificity, which of those facts were in dispute, relying on little more than unsubstantiated assertions and generalizations to oppose CMS's motion. The statements by Guardian (and affirmed by Surveyor Connelly) that Guardian provided "effective," "appropriate," or "aggressive" interventions are, for example, conclusory in nature. They are not tied to specific assertions of fact by CMS; nor are they tied to evidence of specific facts (or inferences from that evidence) proffered by Guardian to rebut the facts relied on by CMS or to undercut the conclusions that CMS drew. General allegations or conclusory statements that are unsubstantiated by evidence of specific facts are insufficient to create a genuine factual dispute. See Ackerman v. Diamond Shamrock Corp., 670 F.2d 66, 69-70 (6th Cir. 1982); Fed. R. Civ. P. 56(e) (to defeat a properly supported motion for summary judgment, the non-moving must submit competent evidence of "specific facts" showing that there is a genuine issue for trial). It is, of course, possible that a rational fact-finder could, based on a set of undisputed facts, draw conflicting inferences that have a material impact on the outcome of the case under the governing law. As we explain in section 6, however, we are not persuaded that the undisputed facts in this case support such inferences.

To the extent that Guardian is relying on Administrator Connelly's declaration to create a triable issue, we find it insufficient. Unlike declarants qualified to provide expert nursing or medical opinion testimony (for example, to evaluate a resident's medical condition, explain professionally accepted standards of care, interpret ambiguity in a medical record, or assess the adequacy of the services provided), Ms. Connelly, the facility's administrator, did not indicate that she had the education, training, or experience that would qualify her to present such an opinion. Compare Lebanon; Madison; Vandalia Park. Ms. Connelly also did not claim to have any personal knowledge of facts different from those shown in the residents' medical records or in the facility's own reports of the key incidents at issue. Although she was "present during the survey," she did not claim to have observed anything different from what the surveyors observed or to have heard any statements from staff members different from what the surveyor reported in the SOD. In addition, her general allegation of bias, inaccuracy, incompleteness, and misrepresentation by the surveyors is unsupported by any specific facts or evidence. Consequently, even if Ms. Connelly was qualified to express an opinion, her assertion that Guardian had provided "appropriate," "aggressive," or "adequate" interventions would be insufficient to create a triable issue because it is unsupported by a rationale or by reference to specific facts. See Shaw by Strain v. Strackhouse, 920 F.2d 1135, 1144 (3rd Cir. 1990) (expert affidavits that are conclusory and lacking in specific facts are insufficient to create a genuine factual dispute); United States v. Various Slot Machines on Guam, 658 F.2d 697, 699-701 (9th Cir. 1981) (same).

    4. CMS was not required to submit affidavits or declarations to authenticate its evidence or to prove or verify the factual assertions in the Statement of Deficiencies.

In opposing CMS's motion for summary affirmance, Guardian implied that it was under no obligation to create a genuine dispute of material fact because CMS had made no attempt to "prove up the content of the documents submitted." See Memorandum in Opposition to Motion for Summary Affirmance at 1. More specifically, Guardian contended that CMS had not offered any evidence "in the form or manner required by [FRCP] 56(e) of '[s]worn or certified copies of all papers or parts thereof referred to in an affidavit,'" and that the Connolly declaration was the only "real evidence" in the case and was more than sufficient to "rule against the party having the burden of proof, here CMS." Id. at 1, 3 (quoting FRCP 56). Guardian renewed this argument in its request for review, asserting that CMS's motion was "incomplete and improper" in part because it was not supported by "properly authenticated evidence within the scope of [Federal Rule of Civil Procedure] 56 requirements." RR Brief at 2. In addition, said Guardian, the ALJ improperly granted CMS's motion because CMS failed to offer declarations or affidavits from the surveyors or others in order to verify the accuracy of the facts reported in the SOD. RR Brief at 8-9; Reply Brief at 2, 4. According to Guardian, "[n]ot one of the surveyors actually testified or submitted a declaration or affidavit attesting to the veracity of any of the allegations in the [SOD]," and CMS's entire case was based on "'evidence' not supported by personal observation attested by one with knowledge, but by bureaucrats who merely orchestrated and oversaw further enforcement of the survey results after they were submitted." Reply Brief at 2.

The key but unstated premise of this argument is that the SOD was not "evidence," and therefore CMS could not prevail to the extent it was relying on that document to establish material facts. (8) See Reply Brief at 2-4. We reject this premise. The SOD is a contemporaneous record of the survey agency's observations and investigative findings, and we have made it clear that CMS may make a prima facie showing of noncompliance based on that document if the factual findings and allegations it contains are specific, undisputed, and not inherently unreliable. Glenburn Home, DAB No. 1806, at 25 (2002); see also Florence Park Care Center, DAB No. 1931, at 13 (2004) (CMS need submit evidence only on facts in dispute); Emerald Oaks, DAB No. 1800, at 42 n.18 (2001) (statement of deficiencies constituted evidence of the facility's prior medication problems because the facility failed to contest the basis for the deficiency citation).

As indicated, the SOD in this case contains a detailed rendering of the relevant facts. These facts paint a picture of the physical and mental condition of all three residents, describe the services provided to them on specific dates, outline the circumstances of certain falls or other accidents involving those residents, and report observations by the surveyors and the content of their conversations with facility staff. As discussed, Guardian's submissions to the ALJ failed to put any of these facts into dispute. Under the circumstances, the SOD was competent and sufficient evidence of the factual assertions therein, and CMS was under no obligation to submit additional corroborative proof, either to meet its burden under the substantive law to make a prima facie case, or to carry its initial burden as the party moving for summary judgment. See Florence Park Care Center (CMS required to submit evidence only with respect to facts that are in dispute); Celotex, 477 U.S. at 325 (noting that the moving party is not required to produce evidence showing an absence of a genuine factual dispute; the moving party need only "show" that there is an absence of evidence to support the nonmoving party's case). Our determination that Guardian did not in fact contest, or intend to contest, the underlying facts is reinforced by its complete failure throughout these proceedings to identify any misstatement of material fact in the SOD. (9)

We find no merit to Guardian's assertions that FRCP 56 required CMS to submit affidavits or declarations in part because the Federal Rules of Civil Procedure are not controlling in these proceedings, and because the ALJ did not indicate that he was applying them. See 42 C.F.R. § 498.61 (providing that the ALJ may admit evidence that is inadmissible under the rules of evidence applicable to court procedure). Moreover, FRCP 56 does not require the moving party to submit affidavits or declarations in support of a summary judgment motion, (10) and none are necessary to establish material facts that the record shows are not in dispute. See Celotex, 477 U.S. at 324.

Guardian asserted that the survey agency's conclusions about the care and services provided to Resident 19 were based on "quadruple hearsay" and that it was improper for CMS rely on such evidence. Reply Brief at 6. This assertion is unavailing because in this administrative proceeding, hearsay is admissible evidence of the facts asserted, provided it has sufficient indicia of reliability. Florence Park Care Center. Guardian made no showing that the hearsay statements in question are unreliable or untrustworthy. (11) In fact, some of the hearsay appears to be inherently reliable because it consists of unrebutted statements by facility employees that are akin to admissions or statements against interest. (12) See, e.g., CMS Ex. 26, at 39 (indicating that a restorative nurse had "verified [at 9:25 a.m. on November 7, 2002] that Resident #19 should not have been left alone at the table" and that the resident should be put back into his geriatric chair). (13)

There is no merit to Guardian's assertion that CMS was required to authenticate its documents in accordance with FRCP 56 or other rules applicable to court proceedings. Title 42 C.F.R. § 498.61 provides that evidence may be received at the hearing even though inadmissible under the rules of evidence applicable to court procedure. The standard of admissibility in this proceeding is found in the Administrative Procedure Act (APA), which permits a fact-finder to consider "[a]ny oral or documentary evidence" except "irrelevant, immaterial, or unduly repetitious evidence." 5 U.S.C. § 556(d). This standard does not require that evidence be authenticated in strict conformance with relevant court rules (FRCP 56 or Federal Rule of Evidence 901). Of course, an ALJ must consider a party's objection to the authenticity or genuineness of an opposing party's documentary evidence, but Guardian made no such objection in opposing CMS's motion; Guardian merely asserted that the SOD and resident medical records could not be used to support CMS's motion for summary judgment unless they were duly "sworn and certified" in accordance with FRCP 56. (14) Guardian's Memorandum in Opposition to Motion for Summary Affirmance at 3. Guardian could hardly object to the authenticity of CMS's documents in any event. CMS produced the declaration of Douglas Wolfe, who stated that CMS Exhibit 1 was a "true and correct" copy of the SOD received from the state survey agency. In addition, CMS accurately noted that the SOD is signed by Guardian's administrator, who did not contend in her declaration that CMS Exhibit 1 was not what it purported to be. The other key documents submitted by CMS are the facility's own medical records, which Guardian expressed an intention to rely upon. See Guardian Ex. 2, at 6 (asserting that resident medical records and nursing notes contradicted the surveyors' statements).

5. The finding of noncompliance is based on the application of the proper legal standard.

We find no merit to Guardian's contentions that it is being found noncompliant under improper legal standards. The Board has articulated a facility's obligation under section 483.25(h)(2) in recent cases. See Northeastern Ohio Alzheimer's Research Center, DAB No. 1935 (2004); Tri-County Extended Care Center. Section 483.25(h)(2) requires the facility to provide each resident with "adequate supervision and assistance devices to prevent accidents." In Woodstock Care Center, the Board analyzed the wording, context, and history of section 483.25(h)(2) and, based on that analysis, set out a framework for evaluating allegations of noncompliance with that requirement. Woodstock Care Center, DAB No. 1726, at 25-30 (2000)(citing 54 Fed. Reg. 5316, 5332 (February 2, 1989)), aff'd, Woodstock Care Center v. Thompson, 363 F.3d 583 (6th Cir. 2003). The Board determined that although section 483.25(h)(2) does not hold a facility strictly liable for accidents that occur, it does require the facility to take reasonable steps to ensure that a resident receives supervision and assistance devices designed to meet his assessed needs and to mitigate foreseeable risks of harm from accidents. Id.; see also Odd Fellow and Rebekah Health Care Facility, DAB No. 1839 (2002). A facility is permitted the flexibility to choose the methods it uses to prevent accidents, but the chosen methods must be adequate under the circumstances. See Woodstock Care Center. Whether the supervision and assistance devices provided are "adequate" depends, of course, on the resident's ability to protect himself from harm. Id.

Guardian asserted that it is being held to two different liability standards under section 483.25(h)(2) -- one that includes the concept of foreseeability, and a second that requires "'every effort' to effectuate a certain outcome (i.e., apparently an outcome of 'no injury') regardless of foreseeability." Reply Brief at 4. This concern lacks foundation because we have made it clear that the standard for compliance with section 483.25(h)(2) does not hold facilities responsible for "unavoidable negative outcomes or untoward events that could not reasonably have been foreseen and forestalled." Tri-County Extended Care Center at 7.

Guardian also complained that nursing facilities are "literally held to an absolute standard of preventing what by definition cannot be prevented -- an accident," and that "[i]f the tag [F-324] is to survive judicial review at the very least the element of foreseeability must be incorporated." RR Brief at 10. These assertions ignore our repeated statements that it "'it is the risk, not the fact, of an accident' that is a prerequisite to finding a deficiency, where practicable steps could have been taken to prevent a foreseeable accident from eventuating." Madison at 8 (quoting Omni Manor Nursing Home, DAB No. 1920, at 38 (2004)); see also Tri-County Extended Care Center at 8 (noting that the "outcome stipulated by the rule does not include 'preventing the unpreventable accident,' but rather taking practicable measures to prevent accidents that are reasonably foreseeable and preventable"). Section 483.25(h)(2) does not require facilities to prevent accidents. Instead, the regulation requires the facility to "ensure" that a resident receives adequate supervision and assistance devices in order to prevent accidents. In other words, the regulation requires the facility to anticipate what accidents might befall a resident and to take steps -- increased supervision or the use of assistance devices -- to prevent them.

Guardian also presented a lengthy argument suggesting that common law tort principles of foreseeability and duty of care should govern our analysis of whether the facility was in substantial compliance. See RR Brief at 10-15. This argument too is without merit. "The relationship between a facility accepting Medicare payment for its care and services and a resident of that facility is defined by federal law and regulations," not state tort law. Tri-County Extended Care Center at 11; Madison Health Care, Inc. at 8 (rejecting a contention that common law negligence standards define a facility's duties under section 483.25(h)(2) and noting that, "[w]hile useful reference may sometimes be made to common-law concepts," federal law, not common law negligence standards, governs the facility's obligations).

    6. CMS is entitled to summary judgment on the issue of whether there is a basis for the CMP.

Above we have discussed why the only testimonial evidence proffered by Guardian is not specific enough to raise a genuine dispute of material fact requiring a hearing. In this section, we examine the evidence regarding specific residents (Residents 44, 37, and 19). We discuss why, even viewing that evidence in the light most favorable to Guardian, no rational trier of fact could find in Guardian's favor and why CMS is entitled to judgment as a matter of law on the issue of whether Guardian was in substantial compliance with section 483.25(h)(2).

a. Resident 44

Resident 44 had multiple diagnoses including Parkinson's disease and dementia. CMS Ex. 1, at 21. He was totally dependent on others for activities of daily living, such as toileting and bathing. Id.; CMS Ex. 7, at 1. According to a Resident Care Kardex Record, his "total dependence" on the staff for a given activity meant "full staff performance of [the] activity." CMS Ex. 7, at 1.

The nursing staff assessed Resident 44 to be at risk for falls. See CMS Ex. 1, at 21. A series of incidents confirmed his susceptibility. On April 16, 2002, he was found lying on the fall-mat on the floor. Id. at 22. He had been previously seen in bed. Id. After this incident, the staff gave him a low bed, put the bed against the wall, put down floor mats, and installed a bed alarm, chair alarm, and lap buddy. Id. On May 22, 2002, he was found on the floor after tipping over his wheelchair. Id. The facility responded by installing anti-tipping devices on the wheelchair. Id. On June 29, 2002, he was found sitting on the bathroom floor in front of his wheelchair with a left eye laceration. Id. An investigation revealed that his seatbelt and lap buddy had been secure, but there was no alarm on his chair or person. Id. at 22-23.

On July 17, 2002, Resident 44 fell from the side of his bed and sustained a hip fracture. CMS Ex. 7, at 6, 9, 10-11. The SOD describes the incident this way:

[A]t 6:30 A.M., the resident was being assisted by a licensed practical nurse (LPN) to bathe. The resident was sitting on the side of the bed. The resident requested privacy while bathing the genital area. The LPN pulled the curtain, told the resident not to stand, and then left the resident unsupervised. Less than two minutes later, this LPN heard the resident fall, pulled the curtain, and observed the resident laying on the floor.

CMS Ex. 1, at 22 (emphasis added).

The medical records submitted by CMS contain information that is not inconsistent with this account. These records include a written statement signed by Elena Hart, LPN, the nurse who was attending to Resident 44 on July 17 when the incident occurred. CMS Ex. 7, at 10. About this incident Nurse Hart wrote that Resident 44 was sitting on the side of bed, that she pulled the curtain to give him privacy, that she instructed him not to try to stand on his own, and that he acknowledged the instruction (saying "Okay I won't" stand). Id. Nurse Hart stated that, "not even two minutes" after reminding Resident 44 not to stand, she "saw [him] falling to the floor[.]" Id.

Progress notes signed by Nurse Doris Harris and dated July 17 with a 6:30 time entry indicate that she was called to Resident 44's room by Nurse Hart shortly after the incident. Id. at 9. According to these notes, Nurse Hart reported that she had instructed Resident 44 not to stand and then found him on the floor after she had turned her head. Id. A second set of notes by Nurse Harris, with the same date and time entry, state:

Elena Hart L.P.N. found "R" on floor . . . Ms. Hart stated, I was supervising "R" a.m. care + went [sic] it was time for "R" to do genital areas, "R" ask me to stand behind curtain for "R" privacy! I told "R" not to stand while "R" siting on side of bed + I stood behind curtain + "R" stood [up] + fell.

Id. at 11.

An investigation report concerning the July 17 incident indicates that Resident 44's bed was in the low position but that the bed alarm was not connected. CMS Ex. 7, at 13. According to the report, no attempt was made to interview Resident 44 about the incident because he was cognitively impaired. Id. The investigator, a registered nurse, indicated that Nurse Hart had acted inappropriately, and that a "suggested preventative action" would be "not [to] leave Resident 44 unattended during personal care while sitting [on] side of bed." Id. at 14.

A handwritten document indicates that the surveyor posed several questions to the nursing staff about the July 17 incident. CMS Ex. 7, at 4. One question was whether any floor mats were in place when Resident 44 fell on July 17. The answer "no" was written next to the question. Id.

The foregoing facts and evidence indicate that Resident 44 was cognitively impaired, at risk for accidents, and in need of the assistance of staff to perform daily activities such as bathing. He also had a series of incidents prior to July 17, 2002 in which he ended up on the floor. After the first incident, the facility, suspecting that he fallen from the bed, installed a bed alarm, gave him a lower bed, and put down floor pads. On two subsequent occasions (May 22 and June 29), Resident 44 ended up on the floor despite the apparent presence of safety precautions ordered by the staff. Resident 44's dependence on staff for personal care and his history of falls made it foreseeable that Resident 44 might fall or have an accident if he attempted to bathe himself while sitting on the side of a bed unobserved. Despite this foreseeable risk, Nurse Hart permitted Resident 44 to bathe himself without help, out of her sight, and without the use of some of the items (the bed alarm and floor mats in particular) that had recently been ordered for his safety. Guardian's own investigator, a registered nurse, indicated that Nurse Hart's actions were "inappropriate" and suggested that Resident 44 not be left "unattended" during personal care. These facts constitute a prima facie showing that Guardian failed to provide Resident 44 with adequate supervision and assistance devices on July 17, 2002.

Guardian asserted that the evidence of foreseeability "is not so one-sided as to result in summary affirmance." Reply Brief at 5. Guardian, however, did not point to any facts, or offer any reasonable interpretation of the evidence, that might permit a fact-finder to conclude that the risk of harm arising from Nurse Hart's actions was insubstantial or unforeseeable. It is, of course, conceivable that Resident 44 had the physical and mental capacity to bathe his genital area without assistance or mishap, and to obey an instruction not to stand while performing that activity. However, Guardian presented no evidence of such ability (such as testimony from Nurse Hart about her actual experience with Resident 44 prior to July 17).

Guardian also suggested that the supervision provided was adequate because Nurse Hart was always in the "very near vicinity" of Resident 44 and was "actively communicating with [him] the whole time leading up to his fall." Id. It is possible that, despite going behind the curtain or turning away from Resident 44, Nurse Hart stayed close enough to him to sense and react effectively to any movement or problem that might have caused him to lose balance and fall from the bed. There is, however, no evidence of specific facts that would support such a conclusion. None of the available records indicate what Nurse Hart did when she pulled the curtain, how close she remained to his bed (or the curtain), and whether she was capable of sensing and reacting to any loss of balance or other problems that Resident 44 might be having. Guardian elected not to present sworn statements from Nurse Hart or anyone else about whether her actions were sufficient to mitigate the risk of harm to Resident 44. Because CMS made a prima facie showing of noncompliance, the burden was on Guardian to proffer evidence of specific facts to create a triable issue concerning the adequacy of Nurse Hart's supervision. We are not obligated to speculate how, if at all, Guardian might choose to carry that burden at an evidentiary hearing. (15)

b. Resident 19

Social service notes dated October 3, 2002 state that Resident 19 was at "risk for falls," that interventions to prevent falls (including a low bed, bed alarm, and lap buddy in his chair) were in place, and that he took Depakote for seizures but was not taking any "psych meds." CMS Ex. 9, at 15. The social service notes also indicate that the "staff puts him in a regular chair which has helped a great deal." Id.

On October 20, 2002, Resident 19 was found sitting on the floor in the activity dining room with an injury to his right elbow. (16) CMS Ex. 9, at 9. He had been sitting in a straight-back chair. Id. at 4. Six to eight residents, but no staff members, were in the room when this incident occurred. Id. Neither Resident 19 nor the other residents who were in the room were able to provide a credible or accurate account of this incident. (17) Id. The facility employee who investigated the incident suggested that future "preventative actions" include an evaluation by the "behavior committee" to address Resident 19's "uncooperative attitude," and a reaffirmation of "interventions" ordered by the facility's "falls committee." Id. at 5.

A partial copy of Resident 19's plan of care shows an entry, dated October 24, 2002, indicating that Resident 19's problems included "actual falls" and "unpredictable behavior." CMS Ex. 9, at 1. According to the plan, the approaches that would be used to address these problems included an immediate psychiatric consultation, feeding Resident 19 away from other residents, and placing him in a geriatric chair (or gerichair) with tray for his safety and the safety of other residents. Id. A form entitled "Evaluation for Physical Restraints" indicates that the gerichair was needed to address Resident 19's increased "combative behavior to self and others," and that this item would be used when he was "OOB" (out of bed). Id. at 10-11.

"Behavior team" meeting notes dated October 25, 2002 state that Resident 19 had recently hit and tried to remove food from another resident, and that a psychiatric consultation would be performed within the next few days. CMS Ex. 9, at 2. The committee outlined specific steps to address his behavior. These steps included having Resident 19 "either eat meals in the activity room being supervised by [the] restorative [nursing staff] or on the unit closely monitored by staff." Id. In addition, say the committee notes, Resident 19 would be put in a gerichair with a tray "until [his] behaviors are under control." Id. On October 25, 2002, Resident 19's plan of care was modified to incorporate the "behavior plan" developed by the committee. Id. at 8.

The SOD indicates that at 9:15 a.m. on November 7, 2002, surveyors observed Resident 19 in the activity dining room seated in a straight-back chair at a dining room table. His gerichair was against the wall. Ten other residents were in the room, and no facility staff were present. The surveyor observed Resident 19 sit at the table unsupervised and unattended for five minutes. At 9:20 a.m., two activity staff entered the area carrying supplies for a planned activity. Then, according to the SOD --

One activity staff informed the surveyor that the restorative nursing staff "told us it was ok to leave the resident because he/she is at a table."

At 9:25 a.m., a restorative staff member entered the central dining room. The restorative staff member verified at this time that Resident #19 should not have been left alone at the table. She indicated "maybe I had better put him/her back into the geriatric chair".

Id. at 27.

What the foregoing facts and evidence unequivocally show is that, on November 7, 2002, the facility did not, contrary to its "behavior plan," ensure that Resident 19 used an assistance device -- a geriatric chair -- that had been ordered for his own safety and the safety of the other residents, and that was to be used whenever he was out of bed. In addition, the record shows that Resident 19 was left unsupervised or unattended in circumstances similar to the ones that existed on October 20, 2002, when he fell from a straight-back chair outside the presence of staff. As we indicated in Lebanon, the Board has found summary judgment to be appropriate when the undisputed facts show that the facility did not follow its own plan of care in providing supervision or assistance devices to prevent accidental injury . Lebanon at 9 (citing Windsor Health Care Center, DAB No. 1902 (2003)). Guardian did not point to any evidence suggesting that it had some reasonable excuse for not following the plan of care. See Reply Brief at 6.

c. Resident 37

According to the SOD and the medical records submitted by CMS, Resident 37 -- a person with dementia, incontinence, and an unsteady gait -- experienced four falls between May 18 and August 10, 2002. CMS Ex. 1, at 38-39; CMS Ex. 8 at 1-9, 11. At least two of these falls were related to her incontinence.

The first fall occurred on May 18, 2002. At 6:00 a.m. on that day, Resident 37 got out of bed to use the bathroom but fell in front of the bathroom. CMS Ex. 1, at 23. After this fall, she was placed in a "take in advance of need program," according to the SOD. Id. The facility presented no evidence about how this program was implemented or its level of success. What is clear, however, is that the program did not entirely eliminate Resident 37's problems with incontinence. According to nursing progress notes, there were at least three occasions between early June and early August on which Resident 37 urinated or defecated in places other than the bathroom. CMS Ex. 8, at 2, 5 (urinated on floor on June 6, defecated in a wastebasket on June 22, and urinated on floor on August 4).

Resident 37 fell a second time on June 3, 2002, sustaining a head injury. CMS Ex. 1, at 24; CMS Ex. 8, at 1. The fall occurred next to her bed. CMS Ex. 1, at 24. An investigation could not determine if the fall was related to her incontinence. Id.

The third fall occurred on August 4, 2002 at 8:45 a.m. CMS Ex. 1, at 24. Nursing progress notes state that she had urinated near the bathroom door and had slipped and fallen in the urine. CMS Ex. 8, at 5. After this incident, the facility placed a commode next to her bed, evidently expecting that she would use it instead of attempting to walk by herself to the bathroom. CMS Ex. 1, at 24.

At 8:00 a.m. on August 10, 2002, Resident 37 fell again. CMS Ex. 8, at 5. A nursing note states that she "slipped to [the] floor" on her way to the bathroom and had voided a large amount of urine while walking. Id. She was taken to the hospital that day and treated for a broken hip. Id. at 6. A post-accident evaluation form requested information about any "preventative measures" that were in place at the time of the accident. Id. at 10. The evaluator identified no such measures. Id.

What these facts demonstrate is that Resident 37 was at substantial risk of falling in her room while attempting to use the bathroom. By August 9, the day before her most serious accident, Guardian was aware or should have been aware of that risk because she had twice previously fallen -- on May 18 and on August 4, 2002 -- while trying to get to the bathroom. The nursing staff had been instructed after the May 18 fall to take the resident to the bathroom "in advance of need," but the staff had reason to know that this measure was not effective in preventing Resident 37 from attempting to get to the bathroom without assistance because she had urinated or defecated in her room at least three times between early June and the first week of August.

Guardian suggested that the presence of a bedside commode was adequate to mitigate the risk of accidental injury. See Reply Brief at 5. On its face this measure seems to be an appropriate and sufficient response to the risk posed by Resident 19's incontinence and propensity to ambulate on her own to the bathroom. But it is clear that the effectiveness of this measure depended on whether she was capable of reliably using the commode instead of trying to walk to the bathroom on her own. As indicated, Resident 37 had dementia. According to July 2002 psychiatric and physical therapy records reviewed by the surveyor, Resident 37 was also uncooperative at times and had poor judgment and safety awareness. CMS Ex. 8, at 11. These circumstances, which the facility was aware of or should have been aware of in early August, call into serious question whether Resident 37 was capable of using the commode when necessary. Nothing in the record of this case indicates that the facility considered these circumstances in deciding whether placement of a commode would be adequate to mitigate the risk of harm. There is also no evidence that the facility actually assessed Resident 37 to determine the likelihood that she would use the commode.

Assuming (as we must) that placement of a bedside commode could be considered an adequate response to the circumstances existing on August 4, the facility soon had reason to know that this measure might not be effective because, on August 6, Resident 37 again urinated on the floor. CMS Ex. 8, at 5. Given her known behavioral problems and the fact that she had recently fallen due to incontinence, the August 6 incident should have caused the facility to reevaluate whether its preventive measures were adequate under the circumstances. There is, however, no evidence that the nursing staff performed such an evaluation until after Resident 37 fell on August 10. Surveyor notes indicate that when Resident 37 returned from the hospital on August 14, 2002, the nursing staff reevaluated her care plan and decided to install a bed alarm and bring her to the toilet every two hours. CMS Ex. 8, at 11.

Guardian asserted that "CMS failed to demonstrate that anything but constant supervision might have prevented" the injury Resident 37 sustained on August 10. Id. at 6. CMS was not required to make such a demonstration, however. All that CMS needed to do to carry its burden of proof was to show that Guardian had failed to take reasonable and adequate steps to mitigate a foreseeable risk of harm to a particular resident. See Northeastern Ohio Alzheimer's Research Center.

The only reasonable interpretation of the facts is that Guardian's preventative measures were inadequate to address the foreseeable risk of harm to Resident 37 on August 10. Incontinence and a propensity to ambulate in her room without assistance were Resident 37's two most prominent and foreseeable risk factors. The available evidence suggests that presence of the bedside commode did not alleviate her incontinence or, as the August 6 incident suggests, make it less likely that she would attempt to ambulate by herself to the bathroom. Moreover, her behavioral and cognitive problems raise questions about her ability to use the commode independently. In addition, the fact that Resident 37 continued to urinate or defecate outside the bathroom after her first fall in May 2002 suggests, absent evidence to the contrary, that the "take in advance of need program" program was either inherently inadequate or not implemented in a consistent and effective manner.

Guardian suggested that incontinence briefs were the only truly effective preventive measures for Resident 37, but that requiring her to use them would effectively prevent the facility from carrying out its obligation under 42 C.F.R. § 483.25 to maintain each resident's highest practicable physical and mental well-being. Reply Brief at 5. Guardian, of course, offered no evidence to support this assertion, and its post-August 10 decision to install a bed alarm and take Resident 37 to the bathroom every two hours suggests that there were measures other than incontinence briefs that could have been taken to lessen the risk of harm.

    7. CMS is not entitled to summary judgment concerning the duration of the CMP.

In Lebanon, we stated that "where the duration of a per day CMP or the reasonableness of the amount of the CMP are at issue, an ALJ may not dispose of the case entirely on a summary judgment motion without considering whether there is a genuine dispute of fact material to resolving those issues." Lebanon at 5. Guardian asserted in its reply brief that a hearing was necessary on these issues. Reply Brief at 7-8.

Before the ALJ, Guardian did not object to the amount of the CMP or submit (or point to) evidence that one or more the relevant regulatory factors justified a reduction in the amount. The Board has said that it will not consider issues that could have been presented to the ALJ but were not. Ross Healthcare Center, DAB No. 1896 (2003). Because Guardian could have raised an issue concerning the reasonableness of the CMP before the ALJ but did not do so, we decline to consider the assertion in its reply brief that summary judgment was improper on that issue.

As for the duration of the CMP, Guardian's administrator asserted in her declaration that it would be inappropriate to leave the CMP in effect after November 14, 2002 because the survey agency found, during the December 5, 2002 revisit, that the facility's noncompliance with section 483.25(h)(2) had been corrected as of November 14, 2002. CMS did not deny that ODH had made such a finding. CMS suggested, however, that ODH's revisit determination concerning tag F324 was immaterial, pointing out that the CMP continued to accrue after November 14 because other deficiencies were found not to have been corrected until December 5. See CMS Reply Brief in Support of its Motion for Summary Affirmance, at 8 n.12.

The regulations governing the duration of a CMP are found in 42 C.F.R. §§ 488.454 and 488.440. Section 488.454(a) provides that "alternative remedies," such as a per day CMP, continue to accrue until "[t]he 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." Section 488.454(e) states that an alternative remedy may terminate on a date prior to a revisit survey if the facility "can supply documentation acceptable to CMS or the State survey agency that it was in substantial compliance" on that earlier date and was capable of remaining in substantial compliance. The language of section 488.440(h)(1) expresses the same concept, with specific reference to a CMP: "If an on-site revisit is necessary to confirm substantial compliance and the provider can supply documentation acceptable to CMS or the State agency that substantial compliance was achieved on a date preceding the revisit, penalties are imposed on a per day basis until the date of correction for which CMS or the State receives and accepts written credible evidence." Section 488.440(b) states that a per day CMP is "computed and collectible . . . for the number of days of noncompliance until the facility achieves substantial compliance."

In view of these regulatory provisions, we do not agree with CMS that ODH's finding concerning tag F324 during the December 5 revisit is immaterial in this case. As indicated, ODH determined that Guardian did not achieve substantial compliance with all participation requirements until December 6. See Guardian Ex. 2, at 19. Based on this determination, we would ordinarily conclude, pursuant to section 488.454(a), that the per day CMP continued to accrue until December 6, the day that Guardian attained substantial compliance with all requirements, "as determined by" the State. CMS has complicated the issue, however, by seeking summary judgment based on a single deficiency. Because CMS abandoned (for purposes of its motion) its reliance on deficiencies placed in issue by the facility, the Board must assume that findings in favor of the facility would have been made on the other alleged deficiencies whose existence was a basis for the CMP. (18) Madison Health Care, Inc. This assumption makes it necessary to determine whether ODH did, in fact, determine that Guardian had corrected its noncompliance with section 483.25(h)(2) prior to the December 5 revisit: if the State determined that Guardian was in substantial compliance with that regulation on November 14, 2002, we would be compelled to find that Guardian was in substantial compliance with all participation requirements on November 14 and to terminate the CMP as of that date.

CMS suggested that any determination by the State about whether Guardian had attained substantial compliance has no effect on the duration of a CMP because, pursuant to 42 C.F.R. § 488.412, a State's certification of compliance is only a recommendation about which CMS makes the final decision. Response Brief at 16, n.19. Sections 488.454 and 488.440 plainly state, however, that a State determination of substantial compliance may serve as a basis for terminating the accrual of a CMP. CMS did not indicate why we should ignore the plain language of these regulations.

CMS also suggested that it would be improper to find that Guardian was in substantial compliance prior to the December 5 revisit because Guardian offered no "written credible evidence" that it came into substantial compliance earlier. We do not agree, however, that Guardian was required to submit such evidence under these circumstances. We interpret section 488.454(a) as saying that, if a State "determines" that substantial compliance (with certain requirements) has been achieved by a certain date, then the CMP stops accruing on that date, whether the State's determination is based on a revisit or on the examination of written credible evidence. Consequently, to establish that it was in substantial compliance with section 483.25(h)(2) prior to the December 5 revisit, it is sufficient for Guardian to show that the State "determined" it to be in substantial compliance prior to the revisit. (If the State made such a determination, then it is reasonable to assume that it saw or was given credible documentation of an earlier return to substantial compliance.)

Terminating the CMP on a date prior to revisit would, under these circumstances, be consistent with the general rule that a CMP may be imposed only for days on which the facility is not in substantial compliance. It would also be consistent with CMS's enforcement action in this case. CMS determined that the facility had attained substantial compliance with all participation requirements as of December 6, 2002. Although that determination of substantial compliance was not made until late December 2002, CMS terminated the CMP on December 6, the date on which Guardian attained substantial compliance with all requirements (as determined by the State). See Guardian Ex. 2, at 19-20.

Because we conclude that Guardian has created a genuine dispute of material fact concerning the duration of the CMP, we remand this case to the ALJ to resolve that dispute and make an appropriate finding concerning the duration of the CMP. Our action should not be construed as preventing CMS from submitting evidence and obtaining findings of fact and conclusions of law concerning deficiencies in addition to the one addressed thus far.

Conclusion

We affirm the ALJ's determination that Guardian was not in substantial compliance with 42 C.F.R. § 483.25(h)(2). We also affirm his finding that the amount of the per day CMP imposed by CMS for Guardian's noncompliance was reasonable. We conclude, however, that CMS is not entitled to summary judgment concerning the duration of the CMP. Accordingly, we remand the case to the ALJ for additional proceedings to resolve that issue and to take any other action not inconsistent with this decision.

JUDGE
...TO TOP

Cecilia Sparks Ford

Donald F. Garrett

Judith A. Ballard
Presiding Board Member

FOOTNOTES
...TO TOP

1. Guardian was formerly known as Windsor Health Care Center.

2. The SOD states that this incident occurred on November 17, 2002. CMS Ex. 1, at 21. CMS indicated in the brief supporting its motion for summary affirmance that the November 17 date was a clerical error, and that Guardian's own records confirm that the incident took place on July 17, 2002, not November 17, 2002. Those records do in fact show that the incident occurred on July 17, 2002, and Guardian has not alleged or shown otherwise. See CMS Ex. 7, at 9.

3. CMS indicated that Guardian's most serious ongoing deficiency as of December 5 was a failure to prepare and serve food under sanitary conditions. Guardian Ex. 2, at 19.

4. The January 31, 2003 letter did not mention CMS's decision to prohibit Guardian from offering nurse aide training and competency evaluation.

5. CMS stated in the motion that it was not seeking summary affirmance of the $50 per day CMP imposed on December 5, 2002.

6. See also Carrier Mills Nursing Home, DAB No. 1883, at 3-4 (2003) ("On the issue of whether there is a factual basis for the CMP, CMS is entitled to summary judgment if it has (1) made a prima facie showing that the petitioner was not in substantial compliance with one or more Medicare participation requirements, and (2) demonstrated that there is no dispute about any material fact supporting its prima facie case and that it is otherwise entitled to judgment as a matter of law. CMS is not entitled to summary judgment if the petitioner has proffered evidence that would permit an ALJ to conclude that it was in substantial compliance with the participation requirements during the relevant period"); 10A Wright, Miller & Kane, Federal Practice and Procedure § 2727 ("If the movant makes out a prima facie case that would entitle him to a judgment as a matter of law if uncontroverted at trial, summary judgment will be granted unless the opposing party offers some competent evidence that could be presented at trial showing that there is a genuine issue as to a material fact. In this way the burden of producing evidence is shifted to the party opposing the motion" (footnotes omitted)).

7. We assume that Guardian was referring to, among other things, the nursing staff's decision to put a commode next to Resident 37's bed after her fall on August 4, 2002. But, as we explain in section 6 (below), no rational trier of fact could, based on the record as a whole, conclude that this measure was "effective."

8. Guardian stated in its request for review that Jennifer Connolly's declaration was "more than sufficient to rebut CMS's bare statement of deficiencies." RR Brief at 9.

9. As indicated, the SOD misstated certain dates, but CMS identified the correct dates by referring to the resident records submitted by CMS. See CMS Motion for Summary Affirmance, at 5 n.7.

10. FRCP 56(a) states that a party may move for summary judgment "with or without" supporting affidavits. FRCP 56(c) states that summary judgment may be entered "if the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and that the moving party is entitled to a judgment as a matter of law" (italics added).

11. Guardian also failed to indicate why these statements, assuming they are admissible, deserve no weight.

12. Guardian did not allege before the ALJ that these employees could not be identified.

13. If this case had been heard in federal court, the SOD, a report of a public agency, would likely have been admissible, as an exception to the hearsay rule, for the purpose of proving the facts asserted. Federal Rule of Evidence 803(8) makes admissible records and reports of public offices or agencies that set forth "matters observed pursuant to duty imposed by law as to which matters there was a duty to report" as well as "factual findings resulting from an investigation made pursuant to authority granted by law, unless the sources of information or other circumstances indicate lack of trustworthiness."

14. Under FRCP 56, unauthenticated or otherwise inadmissible documents may be considered by a court on summary judgment if not challenged. 10A Wright, Kane & Miller, Federal Practice & Procedure § 2722.

15. We said in Lebanon that the fact that a resident is unattended at a particular moment does not necessarily mean that the resident is being unsupervised because expert testimony may establish levels of supervision "that do not necessarily mean being right next to the resident." Lebanon at 15, n.5. Citing this proposition, we held in Madison that written testimony submitted by the facility that a resident had received "general supervision" was sufficient to raise a dispute concerning whether the resident was "unsupervised." Madison Health Care, Inc. at 11. That holding does not help Guardian because it offered no evidence, expert or otherwise, that Resident 44 was still being supervised and supervised adequately when Nurse Hart retreated behind the privacy curtain.

16. Nursing progress notes (CMS Ex. 9, at 9) and a completed "investigation form" (id. at 4-5) confirm the account in the SOD about what occurred on this date.

17. According to the SOD, the facility's quality assurance nurse and social service director were interviewed about the incident. See CMS Ex. 1, at 26. These employees revealed that Resident 19 had been brought into the activity dining room that day, removed from his wheelchair (which had a lap buddy), placed in a regular straight back chair, and left unattended. Id. Resident 19 then fell from the chair and sustained an elbow injury. Id.

18. In making this assumption, we in no way prejudge whether the other deficiencies might be sustained by the ALJ after taking evidence and holding a hearing about them.

CASE | DECISION | JUDGE | FOOTNOTES