SUBJECT: Clermont Nursing and Convalescent Center,

Petitioner,

Centers for Medicare & Medicaid Services

FINAL DECISION ON REVIEW OF
ADMINISTRATIVE LAW JUDGE DECISION

Clermont Nursing and Convalescent Center (Clermont or Petitioner) appealed the September 25, 2003 decision by Administrative Law Judge (ALJ) Keith W. Sickendick affirming the determination by the Centers for Medicare & Medicaid Services (CMS) to impose a $650 per day civil money penalty (CMP) against Clermont for failure to comply substantially with certain Medicare participation requirements. Clermont Nursing and Convalescent Center, DAB CR1087 (2003)(ALJ Decision). The CMP upheld by the ALJ totaled $33,150 ($650 per day from September 3, 1999 through October 23, 1999). ALJ Decision at 2, citing Court Exhibit 1.

The ALJ made 22 findings of fact (FFs) and 11 conclusions of law (CLs). We find that the FFs are supported by substantial evidence and that there are no errors in his CLs. We thus affirm the ALJ Decision in its entirety and sustain the CMP of $33,150.

Background

Legal Background

Clermont is a 208-bed skilled nursing facility (SNF) located in Milford, Ohio, and participates in the Medicare program under a provider agreement with the United States Department of Health and Human Services (HHS). CMS Ex. 15. ⁽¹⁾ Medicare participation requirements are set forth in 42 C.F.R. Part 483. Compliance with these requirements is verified through a survey and certification process set forth in 42 C.F.R. Part 488, Subpart E. Compliance surveys are generally conducted by a state agency under agreement with CMS. Survey findings are presented in a Statement of Deficiencies (CMS 2567), ⁽²⁾ which identifies and discusses each alleged failure by the facility to meet a participation requirement. See CMS State Operations Manual (SOM) Appendix P, § IV. ⁽³⁾ Deficiency findings are identified in the CMS 2567 using data "tags" corresponding to the requirements of participation in 42 C.F.R. Part 483. Id.; SOM Appendix PP.

If a survey reveals that a facility is not in "substantial compliance" with a participation requirement, the facility must submit a Plan of Correction (POC) ⁽⁴⁾ for the cited deficiencies for approval by the survey agency. 42 C.F.R. §§ 488.402(d), 488.408(f). Even if the state agency approves the POC, the facility may not be regarded as in substantial compliance until the survey agency determines, following an onsite revisit or other means of verification, that the deficiency no longer exists. 42 C.F.R. § 488.440(h); SOM §§ 7203.D, 7317.A. "Substantial compliance" is defined as "a level of compliance with the requirements of participation such that any identified deficiencies pose no greater risk to resident health or safety than the potential for causing minimal harm." 42 C.F.R. § 488.301. "Noncompliance" is defined as "any deficiency that causes a facility to not be in substantial compliance." Id.

CMS enforces participation requirements, in part, by imposing remedies for a facility's failure to maintain substantial compliance with those requirements. ⁽⁵⁾ See 42 C.F.R. Part 488, Subpart F. CMS selects the appropriate remedy, if any, based on the "seriousness of the deficiencies." 42 C.F.R. § 488.404(a). ⁽⁶⁾ Deficiencies are categorized by letters A-L, which is a function of their "seriousness" (severity and scope). 42 C.F.R. § 488.408; SOM § 7400E.1; SOM Appendix P, § V. In determining the choice of a remedy within a remedy category, CMS may consider factors that include, without limitation, "[t]he relationship of the one deficiency to other deficiencies resulting in noncompliance" and "[t]he facility's prior history of noncompliance in general and specifically with reference to the cited deficiencies." 42 C.F.R. § 488.404(c).

The amount of the CMP is determined by the facility's history of noncompliance (including repeated deficiencies), its financial condition, the factors set forth in 42 C.F.R. § 488.404, and the facility's degree of culpability. 42 C.F.R. § 488.438(f). ⁽⁷⁾ The CMP accrues 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). CMS may impose a CMP in the range of $3,050 to $10,000 per day for an immediate jeopardy deficiency. 42 C.F.R. § 488.438(a)(1)(i). CMS may impose a CMP in the range of $50 to $3,000 per day for a non-immediate jeopardy level deficiency that either causes actual harm or has the potential for more than minimal harm. 42 C.F.R. § 488.438(a)(1)(ii). ⁽⁸⁾

When an ALJ determines that CMS had a basis for imposing a CMP, the ALJ may not review CMS's exercise of discretion in selecting the CMP as a remedy. 42 C.F.R. § 488.438(e)(2). A facility may, however, appeal the state survey agency's certification of noncompliance which leads to the selection of a CMP. 42 C.F.R. § 488.408(g)(1). A facility may also appeal a CMS determination of the level of noncompliance when a successful challenge would affect either the range of CMP amounts that CMS could collect or a finding of substandard quality of care that results in loss of approval of a nurse aide training program. 42 C.F.R. §§ 498.3(b)(14), 498.3(d)(10)(ii). These appeals are governed by regulations set forth in 42 C.F.R. Part 498. 42 C.F.R. § 498.30(a)(3)(ii).

The Surveys

The Ohio Department of Health (ODH) conducted a standard survey at Clermont from August 30 through September 2, 1999, and an extended survey from September 2 through September 3. CMS Ex. 17. As a result, ODH cited Clermont for 25 deficiencies, in most cases with multiple examples, as reflected on the CMS 2567. CMS Ex. 1. The two most serious of these deficiencies were F-Tag 314 (pressure sores), cited at Level H as constituting a pattern of deficiencies that caused actual harm that was not immediate jeopardy, and F-Tag 324 (accident prevention), cited at Level G as constituting an isolated occurrence that also caused actual harm that was not immediate jeopardy. CMS Ex. 1, at 36-44, 52-59. CMS determined that the deficiency involving pressure sores constituted "substandard quality of care," as defined by 42 C.F.R. § 488.301. ⁽⁹⁾ CMS Ex. 4, at 1; see also CMS Ex. 19 (extended survey worksheet on pressure sores). ODH also cited Clermont for two deficiencies at Level B, five at Level D, fourteen at Level E, and two at Level F. See CMS Ex. 1. ⁽¹⁰⁾

On September 13, 1999, ODH advised Clermont that it would recommend certain remedies for the deficiencies, including a CMP of $650 per day (effective September 3, 1999). CMS Ex. 4, at 2. Clermont submitted a POC, alleging that Clermont would achieve substantial compliance as of October 24, 1999. CMS Ex. 1, at 1; CMS Ex. 5, at 2; see also SOM § 7317.A (POC as allegation of compliance).

On November 4, 1999, ODH conducted a revisit survey and verified Clermont's allegations of substantial compliance, effective October 24, 1999. CMS Ex. 5, at 2. On January 25, 2000, CMS imposed a CMP of $33,150 ($650 daily for 51 days, from September 3 through October 23, 1999). CMS Ex. 2, at 2.

The ALJ Decision

On March 22, 2000, Clermont requested an ALJ hearing, disputing ODH's determination that Clermont had not been in substantial compliance with program requirements and challenging the factual findings of the surveyors. Clermont also disagreed with the "finding of a pattern of deficiencies that constituted actual harm that was not immediate jeopardy." Clermont further asserted that it did not have sufficient cash or profit "to support a monetary penalty, or the loss in revenue produced by the imposition" of the CMP. Clermont stated that it would provide financial data and information to support its contention. Clermont Request for Hearing, dated March 22, 2000, at 1.

An evidentiary hearing before ALJ Sickendick was held April 1-3, 2002, in Cincinnati, Ohio. ALJ Decision at 2. The ALJ limited his analysis to F-Tags 314 and 324 in his decision, determining that these deficiencies alone provided a sufficient basis for the CMP. ALJ Decision at 10-11, citing Beechwood Sanitarium, DAB No. 1824 (2002). ⁽¹¹⁾ His 22 FFs and 11 CLs are found in Section II. Id. at 3-7. The factual and legal bases for each of the six examples under F-Tags 314 and 324 are analyzed in Section III.C.1. Id. at 10-46. The ALJ affirmed the duration of the period of noncompliance from September 9 through October 26, 1999 in Section III.C.2. and upheld the CMP as reasonable in Section III.C.3. ⁽¹²⁾ Id. at 46-49.

Issues

In its Request for Review (Request for Review or RR), ⁽¹³⁾ Clermont excepted to FFs 5-12 and CLs 2-5 for F-Tag 314. RR at 3-12. Clermont also excepted to FFs 13-22 and CLs 6-9 For F-Tag 324. Id. at 12-21. Clermont then contended that the CMP was erroneous, as it was predicated upon unproven deficiencies. Id. at 21.

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).

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 Health & Human Services, 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).

Below, we first discuss whether substantial evidence and applicable law supports the ALJ's FFs and CLs with respect to F-Tags 314 and 324. In reviewing the FFs and CLs, our discussion sets forth the applicable participation requirement. We then summarize the ALJ's findings, followed by Clermont's contentions. We finally analyze whether the ALJ's findings are supported by substantial evidence in the record as a whole. We conclude by discussing whether the CMP is reasonable.

The ALJ thoroughly and comprehensively reviewed the relevant legal standards and documentary and testimonial evidence concerning each resident. The facts included in our discussion provide a framework for understanding this decision and are not a substitute for the ALJ's findings. In reviewing this case, although we do not discuss in detail every argument presented, we have nevertheless considered each and every point in the parties' pleadings. ⁽¹⁴⁾

1. The ALJ's FFs and CLs with respect to F-Tag 314 (pressure sores) are supported by substantial evidence and free of legal error.

A facility's obligations regarding quality of care with respect to the prevention and treatment of pressure sores are set forth in 42 C.F.R. § 483.25(c), which states:

483.25 Quality of care. Each resident must receive and the facility must provide the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the comprehensive assessment and plan of care.

* * * * *

(c) Pressure sores. Based on the comprehensive assessment of a resident, the facility must ensure that - (1) A resident who enters the facility without pressure sores does not develop pressure sores unless the individual's clinical condition demonstrates that they were unavoidable; and (2) A resident having pressure sores receives necessary treatment and services to promote healing, prevent infection and prevent new sores from developing.

The ALJ determined that a facility "bears a duty to 'go beyond merely what seems reasonable to, instead, always furnish what is necessary to prevent new sores unless clinically unavoidable, and to treat existing ones as needed.'" ALJ Decision at 12, citing Koester Pavilion, DAB No. 1750, at 32 (2000); Meadow Wood Nursing Home, DAB No. 1841 (2002), aff'd, Meadow Wood Nursing Home v. Dept. of Health and Human Services, No. 02-4115 (6^th Cir. Mar. 2, 2004); Ridge Terrace, DAB No. 1834, at 15-16 (2002); see also Josephine Sunset Home, DAB No. 1908, at 7 (2004), citing Koester Pavilion and Meadow Wood. The ALJ noted that CMS bore the burden of establishing a prima facie case by showing that (1) a resident without pressure sores upon admission to Petitioner's facility subsequently developed them; or (2) a resident in Petitioner's facility had a pressure sore that worsened or became infected or that resident developed new sores. Id. at 12-13. Once CMS established its prima facie case, the facility would then bear the burden of showing that the development or deterioration of pressure sores was "clinically unavoidable." Id. at 13.

The ALJ then reviewed CMS's fact-specific allegations that Clermont failed to provide the treatment and services to promote healing, prevent infection, or prevent the development of new sores as to Residents 168, 43, 45, 171, 50, and 72. Id. at 13-28. The ALJ upheld CMS's determinations as to all residents, except Resident 45. Id. at 21-22.

a. The ALJ did not commit legal error by concluding that Clermont was required to provide the treatment and services necessary to prevent or promote healing of pressure sores.

Clermont first claimed generally that the ALJ erred in CLs 2-5 because he "impose[d] the wrong analytical framework." Clermont maintained that the "standard of necessity appears nowhere in the regulation," and that a standard of reasonableness is implied by the requirement that a facility provide services consistent with achieving the resident's highest "practicable" level of well-being. RR at 4.

These arguments are not persuasive. The standard of necessity is expressly articulated in the regulation. The primary regulatory requirement is that residents must receive, and facilities must provide, "the necessary care and services" for attainment or maintenance of the highest practicable resident well-being. 42 C.F.R. § 483.25 (emphasis supplied). The regulation then goes on to provide that a resident with pressure sores must receive "necessary treatment and services" for healing, prevention of infection, and prevention of yet more pressure sores. 42 C.F.R. § 483.25(c)(2)(emphasis supplied). We therefore reject Clermont's contention that the standard is "nowhere in the regulation." That argument is belied by the plain language of the regulation.

Moreover, as we explained in Koester Pavilion, in the preamble to the final regulation, CMS expressly declined to use "less demanding" language with respect to a facility's obligation to "ensure" outcome of treatment for pressure sores. Koester Pavilion at 30, quoting 56 Fed. Reg. 48,826, at 48,850 (Sept. 26, 1991). CMS recognized that factors beyond required treatment and services, such as disease process and resident compliance, affect care outcome. Id. However, CMS also recognized that the regulation allows a facility to put forward "available clinical evidence" to show that "a negative resident care outcome was unavoidable." Id. The preamble further provides that facilities "should always furnish the necessary treatment and services" for pressure sore prevention or healing. Id. at 30-31 (emphasis supplied). Thus, a facility may provide necessary treatment and services to ensure the prevention or healing of pressure sores, yet still be confronted with a negative outcome. In that instance, the facility may put forward clinical evidence to show that the outcome was unavoidable.

We thus find that the ALJ did not err by stating what the regulation and Board precedent require, that Clermont furnish those services and treatment necessary for the prevention or healing of pressure sores that are not unavoidable. We thus reject Clermont's challenges to CL 2. For the reasons explained in our discussion of FFs 5-12, we also reject Clermont's challenges to CLs 3-5.

b. The ALJ's findings that Clermont failed to maintain substantial compliance with 42 C.F.R. § 483.25(c) are supported by substantial evidence.

Resident 168

The ALJ discussed the resident's development of new pressure sores while at the facility, inadequate incontinence care, and worsening of an existing pressure sore. ALJ Decision at 13-19. The ALJ noted that resident records documented two Stage II pressure sores on the resident's left hip and right buttock, and Stage I pressure sores on both hands. However, the surveyor identified pressure sores on the resident's scrotum, coccyx, left knee, gluteal fold, and left elbow that were not documented in the records. The surveyor also observed the resident in a urine saturated brief at 1:20 PM, after having been observed sitting in a wheelchair since 9:55 AM. The surveyor alleged that facility records showed that the pressure sore on the left hip worsened between August 31 and September 3, 1999. Id. at 13-14. The ALJ concluded that Clermont had failed to provide necessary treatment and services to prevent or promote healing of pressure sores. Id. at 19.

Clermont excepted to FFs 5 and 6, which read as follows:

5. Resident 168 developed new pressure sores while at the facility; specifically, on August 31, 1999, a surveyor observed two new pressure sores on the scrotum and one on the coccyx.

6. Resident 168's treatment records clearly show a worsening of his left hip pressure sore.

Id. at 4.

With respect to FF 5, Clermont contended that the surveyor's observations of pressure sores on the scrotum were "unreasonable" as the surveyor testified that "pressure sores develop over bony prominences and the scrotum has no bones." RR at 5. Clermont also argued that facility records did not document a pressure sore on the coccyx, contrary to the surveyor's observation, and that Surveyor Truett could not testify as to observations made by Surveyor Sears. Id. at 6. With respect to FF 6, Clermont contended that the left hip pressure sore was not worsening but was healing, only looking worse as the result of autolytic debridement. Id.

We reject Clermont's challenge that surveyor observations of new pressure sores on the scrotum were inconsistent with testimony that pressure sores formed in areas with bony prominences. The ALJ summarized Ms. Truett's testimony as "[p]ressure sores tend to form on pressure points or a bony prominence such as hip bones, elbows, coccyx, knees, heels, and ankles." ALJ Decision at 15; Tr. at 51, 54.

Contrary to Clermont's assertion, Ms. Truett did not testify that pressure sores formed only in areas with pressure points or bony prominences. Ms. Truett's testimony on pressure sores, instead, is that they are created when two surfaces exert direct pressure on one another. Her testimony cannot reasonably be read as stating that pressure sores can only form at pressure points caused by bony prominences. Clermont provided no testimony or other evidence which would establish that pressure sores cannot form on the scrotum.

We also reject Clermont's challenge to the surveyor's observation of the new and unreported sores on the scrotum. Clermont argued that Surveyor Truett could not testify as to observations made by Surveyor Sears. RR at 6, citing P. Ex. 7, at 1-6; CMS Ex. 40, at 1-31.

The ALJ correctly noted that Surveyor Truett, not Surveyor Sears, made the observations pertaining to this resident. ALJ Decision at 16, citing Tr. at 80-88, CMS Ex. 40, and CMS Ex. 52, at 2, 4, 6, 8. Her testimony is supported by her survey notes at CMS Exhibit 52, at 2.

Clermont finally contested Surveyor Truett's testimony that the left hip pressure sore worsened by September 3, 1999. Clermont contended, instead, that the condition of the wound when observed by the surveyor was the result of debridement, and that "the area [would] appear worse, as the non-viable tissues are removed to promote healing." Clermont maintained that after September 3, "the area began to heal as expected and measurements decreased." RR at 5-6. This assertion is not supported by the record evidence. The ALJ correctly concluded that "Resident 168's treatment records . . . clearly show a worsening of the left hip pressure sore that existed at the time of the survey" due to infection. ALJ Decision at 18, citing P. Ex. 7, at 26; CMS Ex. 40 at 6. The evidence cited by Clermont on wound debridement does not undercut the ALJ's analysis.

We thus find the ALJ's FFs 5 and 6 are supported by substantial evidence and that there is no error of law.

Resident 43

The ALJ discussed that Resident 43 was admitted to Clermont with two Stage IV pressure sores on his heels, which were treated and in the process of healing by the date of the survey. The ALJ also noted the surveyors' discovery on September 1, 1999, of an undocumented Stage II pressure sore on the left ankle. This sore was apparently caused by an airhole in a vinyl covered foam boot ("Spanko boot") that the resident wore to protect his heels. After surveyors advised facility staff of the sore, staff placed a piece of adhesive tape over the airhole. ALJ Decision at 19.

Clermont witness Kimberly Parks testified that the new pressure sore was caused by the resident walking in the Spanko boots, which he was not supposed to do. August 12 and 16 entries in the resident's record document him walking while wearing the boots. An August 17 nurse's note reflects a physician's order to discontinue the Spanko boots and to have the resident wear socks and house slippers. The ALJ found, notwithstanding this order, "no evidence . . . that [the resident] was ever counseled or cautioned not to try to walk in his Spanko boots or that the facility dressed him in slippers and socks." The ALJ concluded that the pressure sore on the ankle was avoidable. Id. at 20-21.

Clermont excepted to FF 7, which reads:

7. The sore on Resident 43's ankle at the time of the survey could have been avoided had Resident 43 been placed in socks and slippers on August 17, 1999, as ordered by his doctor, or had tape been placed over the hole in his Spanko boot.

Id. at 4.

Clermont raised several arguments on appeal: (1) The resident was noncompliant with treatment by ambulating himself; (2) the resident was noncompliant with his diet; (3) his "ulcers" were stasis ulcers, not pressure ulcers; (4) he wore the Spanko boots pending receipt of orthotic shoes; (5) the facility treated the ankle sore; and (6) the resident's family did not bring in socks and slippers until September 13. RR at 7-8.

Clermont's arguments are without merit. The ALJ considered and rejected Clermont's contentions concerning noncompliance and characterization of the wounds as stasis ulcers. As Clermont provided no new evidentiary or legal argument on these points, we affirm the ALJ's findings. ALJ Decision at 21. We also reject Clermont's remaining arguments. Clermont did not deny that the August 17 nurse's note reflects a physician order to discontinue use of the Spanko boots. It is uncontested that the resident continued to wear the boots after the physician's order and that a pressure sore developed. Moreover, Clermont did not contest the ALJ's conclusion that Clermont did not advise the resident against walking in those boots.

We thus find that the ALJ's FF 2 is supported by substantial evidence and that there is no error of law.

Resident 45

The ALJ concluded that CMS failed to establish a prima facie case that Clermont was not in substantial compliance with this requirement. CMS did not appeal this finding, which we therefore leave undisturbed.

Resident 171

The ALJ discussed a Stage II pressure sore on the resident's outer left ankle which had not been "discovered or recorded" before the survey and a pre-existing sore on the upper right thigh. The surveyor observed the resident turned to the left side, weight on the pressure sore on the left ankle. The ALJ noted that it was undisputed that the resident had Parkinson's disease, which created "constant movement of her legs" and friction between the resident's left ankle and bed sheets. The ALJ concluded:

Petitioner has not shown that the [left ankle] pressure sore was unavoidable and it does not appear from the evidence of record that Petitioner had implemented any interventions to prevent the development of pressure sores even though it was obvious that Resident 171 was spending a significant amount of time resting on her left side and had nearly constant involuntary leg movements which caused friction with the bed sheets.

ALJ Decision at 22-24.

Clermont excepted to FFs 8 and 9, which read:

8. Resident 171, who was admittedly at risk for the development of pressure sores, did develop a pressure sore on her left ankle.

9. Petitioner implemented no interventions to prevent development of pressure sores on Resident 171's left ankle even though it was obvious that Resident 171 was spending a significant amount of time resting on her left side and had nearly constant involuntary leg movements which caused friction with the bed sheets.

Id. at 4.

Clermont argued that the ALJ erred because: (1) the resident's Parkinson's disease caused involuntary movements that created friction with the bed sheets; (2) the facility had multiple interventions in place, including a specialty mattress; (3) pressure relieving devices on the footrest of the reclining chair would not have prevented the ankle sore created by friction with bed sheets; (4) the resident's care plan called for turning the resident on her left side; and (5) staff conducted checks each half hour. RR at 8-9.

We affirm the ALJ's findings. First, Clermont did not deny that a sore developed on the outer left ankle during the resident's stay at the facility. Second, Clermont also did not deny that Resident 171 was turned in bed onto her left side, and thus onto her left ankle, without an intervention to relieve friction between the left ankle and the bed sheets. In short, the record evidence does not support Clermont's argument, albeit implied, that the left ankle sore was unavoidable. Cf. RR at 9, citing CMS Ex. 1, at 36, CMS Ex. 31, at 19; Tr. at 424; P. Ex. 6, at 13. ⁽¹⁵⁾

We thus find that the ALJ's FFs 8 and 9 are supported by substantial evidence and that there is no error of law.

Resident 50

The ALJ described the development and treatment of a pressure sore on the resident's left hip between July 28 and August 30, and the documentation of a new left hip pressure sore on September 3. Care plan interventions included a wheelchair pad, repositioning every two hours, and incontinence care. During the survey, the surveyor observed the resident "restrained in his wheel chair" without the wheelchair pad. The surveyor also observed the resident in bed with a wet brief, wet bed linens, and the strong odor of urine. The ALJ noted that Clermont did not deny the allegations in the CMS 2567, but argued instead that the resident demonstrated overall improvement after the survey. ALJ Decision at 24-26.

Clermont excepted to FF 10, which reads:

10. Petitioner failed to follow Resident 50's care plan and Resident 50 developed new pressure sores as a result.

Id. at 4.

Clermont argued on appeal that the ALJ erred because: (1) the resident was combative and agitated, which interfered with care; (2) the resident "has since become a different person," with weight gain and no skin problems; and (3) the wheelchair pad would not have protected the pressure sore on the resident's hip. RR at 10-11.

The ALJ considered each of these arguments in his decision and concluded that Clermont had not denied the allegations in the CMS 2567. ALJ Decision at 25-26. We agree. ⁽¹⁶⁾

We thus find that the ALJ's FF 10 is supported by substantial evidence and that there is no error of law.

Resident 72

The ALJ described that Clermont had assessed this resident, who also received hospice services, as incontinent, totally dependent on staff for care, and at risk for pressure sores. That assessment also reflected a large reddened area on the resident's coccyx and an "open pressure area" in the center. Interventions included incontinence care and repositioning every two hours. The surveyor first observed the resident lying on her back, with knees to the right. The resident was not repositioned for over three hours, except that the head of the bed was elevated. The surveyor also observed a large amount of urine and dried feces during incontinence care, as well as a previously unidentified or recorded Stage II pressure sore. The ALJ concluded that Clermont had not presented evidence that undermined the surveyor's observations and that it had not disputed the development of a new pressure sore or that the existing one worsened. ALJ Decision at 26-28.

Clermont excepted to FFs 11 and 12, which read:

11. Resident 72 experienced a worsening of an existing pressure sore and development of a new sore.

12. Petitioner failed to reposition Resident 72 in accordance with her care plan and failed to provide timely incontinent care, as evidenced by the presence of dried feces on the resident's skin.

Id. at 4.

Clermont argued on appeal that the ALJ erred because: (1) the resident was an endstage congestive heart failure (CHF) patient receiving hospice care; (2) the head of the resident's bed was elevated to avoid fluid buildup in the lungs and constituted repositioning; and (3) the surveyor was not credible because a simultaneous observation of dried feces and a large amount of urine is impossible. RR at 11-12.

The ALJ considered each of these arguments in his decision and found that Clermont had not denied the crux of the deficiency: the undisputed development of a new pressure sore and worsening of an existing sore, neither of which were unavoidable. The ALJ further noted that CMS presented undisputed evidence of improper incontinence care and failure to turn the resident in accordance with the POC. ALJ Decision at 27-28. ⁽¹⁷⁾

We affirm the ALJ's findings. We disagree with Clermont that the development of the new pressure sore, and worsening of the existing one, were the unavoidable results of the resident's CHF, given the substantial evidence supporting that Clermont failed to follow care planned interventions of incontinence care and turning consistent with the POC. We have also fully considered the remainder of the record as a whole, including Surveyor Truett's testimony and supporting documentation, and find it consistent with her observations. ALJ Decision at 27, citing Tr. at 73-79; CMS Ex. 52, at 6, 8.

Clermont also argued that the deficiency is unsupportable because the resident was receiving palliative care as a hospice patient, not care and services for the treatment or prevention of pressure sores. ALJ Decision at 27, citing Tr. at 508 (Parks testimony); RR at 11. We have previously held that simply because a nursing home resident elects hospice care does not mean that the facility is thus absolved from complying with Medicare participation requirements (including the prevention and treatment of pressure sores). We explained as follows:

First, the fact that a resident in a nursing home might elect hospice services does not relieve the facility from compliance with federal participation requirements. The hospice and the SNF must prepare a coordinated POC which "must identify the care and services which the [SNF] and hospice will provide . . . ." SOM, Ch. 2, § 2082.A.; see also SOM, Ch. 10, Appendix P-53. Both the hospice and the SNF must keep "[e]vidence of this coordinated plan of care . . . in [their] clinical records . . . ." SOM, Ch. 2, § 2082.A. "Even though the [SNF] is the hospice patient's residence for purposes of the hospice benefit, the [SNF] must still comply with all [SNF] Requirements for participation in Medicare or Medicaid." Id. (emphasis supplied). To the extent that [the facility] argued that ODH should not have surveyed a hospice patient in a survey of SNF residents (which is entirely unclear from [the] Request for Review), this argument is based on an error of law.

Second, the resident's prognosis is irrelevant in assessing whether the quality of services provided meets federal participation requirements. As we have observed, resident neglect ⁽¹⁸⁾ is not excused by the fact that a resident is terminally ill.

Batavia Nursing and Convalescent Inn, DAB No. 1911, at 48-49 (2004)(emphasis in original).

A hospice election requires that the resident have a terminal illness, meaning a prognosis of less than six months life expectancy. The first election may be extended by the resident through successive elections up to an "indefinite duration." Id. at 48, n.48, citing 42 C.F.R. §§ 418.20, 418.3, and 418.21. We do not read these regulations as permitting a facility to discontinue providing services to treat or prevent pressure sores for a hospice resident who could conceivably live up to six months or longer. Moreover, the "Plan of Care for Preventive Skin Care" initiated by Clermont on May 20, 1999, and revised on September 12, identifies Resident 72 as receiving hospice services, yet lists multiple interventions for pressure sores and states that she will be free of new skin breakdown by December 12. P. Ex. 17, at 27. Clermont offered no explanation as to why it initiated and renewed a preventive skin care POC for a hospice resident, while now arguing that it has no obligation to do so.

We thus find that the ALJ's FFs 11 and 12 are supported by substantial evidence and that there is no error of law.

2. The ALJ's FFs and CLs with respect to F-Tag 324 (accident prevention) are supported by substantial evidence and free of legal error.

A facility's obligations regarding quality of care with respect to the supervision and assistance devices required to prevent accidents are set forth in 42 C.F.R. § 483.25(h)(2), which states:

483.25 Quality of care. Each resident must receive and the facility must provide the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the comprehensive assessment and plan of care.

* * * * *

(h) Accidents. The facility must ensure that - . . . (2) Each resident receives adequate supervision and assistance devices to prevent accidents.

The ALJ reviewed Board precedent and the legislative history of the Act to conclude, correctly, that quality of care regulations at 42 C.F.R. § 483.25 reflect the desired outcome of care, rather than processes by which a facility must provide that care. He noted that accident prevention was a function of reducing or eliminating foreseeable risks and that an accident need not occur, nor a resident suffer injury, before a violation could be found. ALJ Decision at 28-29, citing Woodstock Care Center, DAB No. 1726, at 25-27 (2000), aff'd, Woodstock Care Ctr. v. Thompson, No. 01-3889 (6^th Cir. 2003); Asbury Center at Johnson City, DAB No. 1815 at 12 (2002), aff'd, Asbury Center v. Dept. of Health & Human Svcs., No. 02-3438 (6^th Cir. 2003); Odd Fellow and Rebekah Health Care Facility, DAB No. 1839, at 6-7 (2002); Koester Pavilion at 24-26; Omnibus Budget Reconciliation Act of 1987, Pub. L. 100-203; 54 Fed. Reg. 5316 (1989).

The ALJ then reviewed CMS's allegations concerning Residents 147, 72, 6, 14, 163, and 60. Id. at 30-46. He upheld CMS's determinations of a deficiency as to all residents, finding an isolated instance of actual harm with respect to Resident 72 and the potential for more than minimal harm, without injury, as to the others. Id. at 46. He then concluded that "in each of the six examples, Petitioner either knew or reasonably should have known that the residents were at risk for accidents, but Petitioner failed to take reasonable measures to reduce or eliminate the risk of accidental injury." Id.

a. The ALJ did not err in analyzing Clermont's duty to prevent foreseeable accidents.

Clermont argued that the ALJ erred in his CLs 6-9, and that he conducted an "improper analysis" in applying the standards of adequate supervision, assistance devices, and risk reduction in Odd Fellow, Asbury, and Koester Pavilion. RR at 12-13, citing CLs 6-9. Clermont also argued that the ALJ erred in analyzing the requirements of a prima facie case under 42 C.F.R. § 483.25(h)(2). Clermont contended that CMS was required not only to prove the occurrence of an accident, but also causation, i.e., that the cause of the accident was related to the facility's lack of supervision or assistance devices. Id. Clermont further contended that accident risk was an inadequate basis for a deficiency citation. Id., quoting Gold Country Health Center, CR533 (1998)("By itself, risk to resident's health or safety cannot establish the existence of noncompliance with any given participation requirement.").

Clermont's arguments fail. First, the ALJ applied the correct legal standards concerning the level of supervision and assistance devices required to reduce the risk of accidents. ALJ Decision at 28-30. ⁽¹⁹⁾ In short, the regulation requires that a facility prevent foreseeable accidents by providing adequate supervision and assistance devices to residents. ⁽²⁰⁾ As the Board has explained, this requires that facilities take all "practicable" measures to achieve that regulatory end. Josephine at 14. Facilities must evaluate risks "not [through] prescience but reason and professional judgment in assessing what can be done to make residents (given their special needs) safe through removing accident hazards, providing appropriate devices, and ensuring adequate supervision." Id. at 15; Windsor at 5 (calling for "reasonable steps" to "mitigate foreseeable risks of harm.") Stated differently, the facility must eliminate or reduce the risk of accident to the greatest degree practicable.

As a risk-oriented analysis, this does not require that either an accident or resident injury actually occur for a violation to exist. We recently summarized this risk-based approach as follows:

In prior decisions, the Board has thoroughly considered and rejected the concept that an accident is a prerequisite to a deficiency finding under section 483.25(h)(2). See, e.g., Price Hill Nursing Home, DAB No. 1781 (2001)("The intent of the regulation is to prevent accidents; thus, the fact that no accident occurred because no resident touched the unattended cart or the unlocked supply closet does not establish compliance with this regulation."); Woodstock Care Center, DAB No. 1726, at 17 (2000), aff'd, Woodstock Care Ctr. v. Thompson, No. 01-3889 (6^th Cir. 2003) ("[O]bservations and the occurrence of events other than accidents may suffice to expose the absence of supervision adequate to prevent accidents."). The Board has pointed out introductory language in 42 C.F.R. § 483.25 (that a facility "must provide the necessary care and services to attain or maintain the highest practicable . . . well-being, in accordance with the comprehensive assessment and plan of care") in upholding deficiency findings where a facility failed to follow steps in a plan of care that were directed at preventing accidents. See Coquina Center, DAB No. 1860 (2002).

Omni Manor Nursing Home, DAB No. 1920, at 38-39 (2004)(emphasis deleted), citing Beechwood at 59 (risk analysis of obligation to keep environment free of accident hazards). ⁽²¹⁾

We find that the ALJ did not err in his statement and application of the governing legal standards. We therefore reject Clermont's challenges to CLs 6-9 and now turn to its fact-based challenges to FFs 13-22.

b. The ALJ's findings that Clermont failed to maintain substantial compliance with 42 C.F.R. § 483.25(h)(2) are supported by substantial evidence.

Resident 147

The ALJ described this cognitively-impaired resident as having a documented history of repeated elopement attempts from the facility. Surveyor Truett testified that another surveyor had witnessed Resident 147 wandering outside the facility at the beginning of the survey. An Interdisciplinary Plan of Care called for multiple interventions to respond to the resident's wandering propensities, including a "netted door guard" on the A and C wings of the facility. Surveyor Truett testified that the C wing had no netted door guards during the survey, while Clermont witness Beth Johnson testified that Resident 147 resided on the C wing. Tr. at 93-94, 480. Ms. Johnson explained that there were no netted door guards on Resident 147's hallway, since she wore a "watchmate" wrist alarm and the doors on her hallway were alarmed. The ALJ found that CMS failed to present a prima facie case that Resident 147 was observed outside the facility by the surveyor during the survey. The ALJ nonetheless upheld the deficiency, finding that Clermont failed to provide the netted door guards called for by the resident's plan of care. ALJ Decision at 30-32 (citations omitted).

Clermont excepted to FFs 13 and 14, which read:

13. Petitioner knew or should have known that Resident 147 was at risk for elopement.

14. The netted door guards required by Resident 147's plan of care were not in place during the survey.

Id. at 4.

Clermont conceded on appeal that Resident 147 was at risk for elopement. RR at 14. It argued, however, that the netted door guards were only one of multiple interventions in place and that an Immediate Needs Care Plan dated July 19, 1999 (also bearing dates July 31 and August 30) did not mention the door guards. Clermont also contended, without citation to the record, that a care plan "states netted door guards was [sic] no longer appropriate as the date of that care plan is 1/31/99." Clermont then argued that netting was an intervention on some, but not all, facility doors, since some doors were alarmed. Id. at 15, citing P. Ex. 8, at 12; Tr. at 467.

These contentions are unavailing. First, the number of interventions used does not alter Clermont's failure to provide an intervention listed on the plan of care: a netted door guard on the C wing, where Resident 147 resided. Further, contrary to Clermont's assertion, our review of the record finds no care plan dated January 31, 1999. However, number 10 on the "Interdisciplinary Plan of Care with dates in 1999" referenced by the ALJ lists netted door guards as an intervention on the C wing throughout January, February, July, September, and October 1999. P. Ex. 8, at 25-26; compare P. Ex. 8, at 20 with P. Ex. 8, at 12. The ALJ also considered and rejected Clermont's arguments concerning alarmed doors, which we affirm for the reason stated by the ALJ. ALJ Decision at 32.

We thus find that the ALJ's FFs 13 and 14 are supported by substantial evidence and that there is no error of law.

Resident 72

The ALJ described multiple attempts by this resident to climb out of bed, followed by a fall on August 22, 1999, that resulted in undisputed injury. ALJ Decision at 33-38. Physician's orders in May, June, August, and September called for a bed alarm "to alert staff to unassisted transfers/ambulation." P. Ex. 17, at 14, 10, 4, 1. The physician also ordered the use of one side rail throughout the same period, although an undated handwritten entry on September physician orders changes that number to two. Id. Nurse notes show that the facility used two side rails on July 30 "to prevent injury from falling . . . ." Id. at 40.

It is undisputed that a "tether alarm" was in use at the time of the resident's fall on August 22. ALJ Decision at 34. It is also undisputed that a post-fall assessment indicated that the resident "rolled out of bed on the side without the rail." Id. It is further undisputed that between the August 22 fall and the survey, the facility used two side rails that extended approximately three-quarters of the length of the resident's bed. Id. at 35.

The ALJ rejected Clermont's argument that it used one side-rail prior to the August 22 fall as a form of "progressive restraint," noting that "it is no defense for Petitioner to allege that it failed in its duty to protect a resident from harm because it was fulfilling the duty to use only minimum restraint." Id. at 37. The ALJ further concluded that Clermont remained deficient after the fall by using two three-quarter length side-rails, as the gap between the end of the rails and the foot of the bed created a risk of entrapment for the resident. Id. at 38.

Clermont excepted to FFs 15 and 16, which read:

15. Petitioner knew or should have known that Resident 72 was at risk of falling from bed given that: 1) she repeatedly tried to get out of bed; 2) the restraint free alarm apparently failed to sound when she attempted to get out of bed; 3) the type of alarm specified by her doctor was not used; and 4) on at least one day in July, Petitioner's staff found it necessary to use two side-rails to keep Resident 72 from falling from bed.

16. Resident 72 fell from bed on August 22, 1999, and was injured.

Id. at 4-5.

Clermont argued on appeal that it used one side rail pursuant to the physician's order and to avoid restraining the resident. Clermont further argued that the use of the tether alarm while in a bed constituted use of a "bed alarm" and the fact that the alarm did not work "is not evidence of a violation of [Clermont's] supervision obligations." Clermont further argued that the ALJ erred by failing to establish causation between the alleged deficient practices and the subsequent fall and injury. RR at 16-17.

Clermont's arguments are unconvincing. First, the ALJ amply considered the facility's duty to keep the resident safe from foreseeable accidents in relation to its duty to minimize the use of restraints. Id. at 37. We find nothing in his analysis which warrants reversal. Second, the ALJ covered the testimony of Surveyor Truett which distinguished between a tether alarm (in use at the time of the August 22 fall) and a bed alarm (also referred to as a pressure sensitive alarm). ALJ Decision at 34, 35. Clermont did not dispute this testimony, nor did it dispute that a bed alarm (pressure sensitive alarm) was not in use at the time of the August 22 fall. Finally, as previously discussed, the regulation requires a risk-based analysis; CMS is not required to establish accident causation in determining whether there was a lack of substantial compliance with this requirement. A facility's failure to take certain preventive measures can alone be sufficient. In any event, the record contains substantial evidence that Clermont's failure to use a pressure sensitive alarm and its failure to use two side rails were causative elements in Resident 72's August 22 fall from the bed. ⁽²²⁾

We thus find that the ALJ's FFs 15 and 16 are supported by substantial evidence and that there is no error of law.

Resident 6

The ALJ described this resident as at risk for falls, with a care plan that called for the use of a pressure sensitive bed alarm. The ALJ recounted Surveyor Dunn's testimony that she twice observed the resident in bed on August 31, 1999, with a bed alarm that was not turned on. He noted that Clermont neither addressed nor disputed this testimony. ALJ Decision at 38-39.

Clermont excepted to FF 17, which reads:

17. Resident 6's care plan required the use of a pressure sensitive bed alarm to help prevent falls, but the alarm was not functioning at the time of the survey.

Id. at 5.

Clermont argued on appeal that Surveyor Dunn's testimony was inconsistent with her documented observations. RR at 17, citing CMS Ex. 25 and CMS Ex. 26 [sic]. ⁽²³⁾

As the ALJ pointed out, Clermont failed to contest the surveyor's observations during the hearing, so this issue is not properly before us. Our Guidelines state that we will not consider "issues which could have been presented to the ALJ but were not." Omni Manor at 45, citing Ross Healthcare Center, DAB No. 1896, at 11 (2003)("Since Ross did not argue that it could not have presented this issue to the ALJ, we see no reason why it should be given an opportunity to raise the issue now."). ⁽²⁴⁾

We thus find that the ALJ's FF 17 is supported by substantial evidence and that there is no error of law.

Resident 14

The ALJ described this resident as at risk for falls, with numerous attempts to climb out of bed and multiple falls. Planned interventions included two side-rails, floor mats beside the bed, and a bed alarm. From March 1999 through the survey in September, the facility used three-quarter length side-rails, bed alarms that worked intermittently, and, for a while, one floor mat. The ALJ concluded that none of these interventions were a reasonable response to the risk of injury from falling. ALJ Decision at 39-42.

Clermont excepted to FFs 18 and 19, which read:

18. Petitioner knew or should have known of the risk that Resident 14 would attempt to get out of bed and fall and injure himself.

19. Petitioner's use of a restraint free alarm, three-quarter length side-rails, and a single mat on one side of the bed were all ineffective to minimize or eliminate the risk that Resident 14 would attempt to get out of bed, fall, and injure himself.

Id. at 5.

Clermont argued on appeal that the restraint free alarm was discontinued in March and that Surveyor Dunn's testimony to the effect that she observed the resident with legs sticking out of the gap below the side-rails on the side with no rubber mat, without any alarm sounding, was inconsistent with her documented observations. RR at 18, citing CMS Ex. 26.

Clermont's arguments miss the point. The crux of the ALJ's determination is that the interventions attempted, including the restraint free alarm, were not reasonable responses to the resident's repeated and successful attempts to climb out of bed and injure himself "until he was placed on a low bed with bolsters." ALJ Decision at 42. Clermont did not dispute this conclusion. Clermont also did not dispute that while an alarm may have been discontinued in March, a bed alarm was once again in use by the time of the survey. CMS Ex. 26, at 4 ("RFA at all times")("8/18/99 Bed alarm"), 7 ("8/24/99 RFA also utilized."). Clermont also did not contest the substance of the surveyor's observation that the alarm was not sounding during her observation, arguing instead that her observations are not recorded in CMS Exhibit 26. The surveyor's observations concerning Resident 14 are recorded at CMS Exhibit 29, at 15 and are consistent with her testimony. Tr. at 323. ⁽²⁵⁾

We thus find that the ALJ's FFs 18 and 19 are supported by substantial evidence and that there is no error of law.

Resident 163

The ALJ described this resident as requiring the use of a restraint free alarm while in his wheelchair to prevent him from leaning forward and falling out. ⁽²⁶⁾ The ODH surveyor observed the resident at various times without the alarm attached "and without supervision." The ALJ concluded that (1) Clermont did not dispute that the alarm was not attached to the resident; and (2) "Petitioner never alleges that Resident 163 was under adequate supervision to prevent falls at the time his alarm was not connected." ALJ Decision at 42-44.

Clermont excepted to FF 20 and 21, which read:

20. Petitioner knew that Resident 163 was at risk of falling forward from his wheelchair and that a restraint free alarm was required to minimize or eliminate the risk.

21. During the survey, Resident 163's restraint free alarm was not attached to him while he was in his wheelchair.

Id. at 5.

Clermont argued on appeal, in essence, that the surveyor's documented observations reflect staff presence in the hallway and thus, Clermont implied, adequate supervision. Clermont also maintained that the surveyor's testimony was inconsistent with her documented observations. RR at 19.

Clermont's arguments fail. First, the crux of the deficiency is the undisputed surveyor observation that Clermont failed to attach the tether alarm to the resident, a precondition to its effectiveness. Second, Clermont's contention that Ms. Dunn's notes reflect staff supervision, and therefore indicate that her testimony is inconsistent with her observations, is wholly lacking in merit. Ms. Dunn's notes unambiguously state that at 10:08 AM, the resident was not under "direct supervision" and the alarm was "not attached . . . ." At 10:10 AM, she wrote that no one was in the hall. At 10:13 AM, she recorded that the nurse in the hall passing medications was not looking at the resident. A restorative aide is later documented as leaving the resident to get a walker, but without attaching the alarm. A nurse in the vicinity is documented as talking to someone else and not looking at the resident. CMS Ex. 29, at 14-15. We therefore reject Clermont's contention that the resident was adequately supervised.

We thus find that the ALJ's FFs 20 and 21 are supported by substantial evidence and that there is no error of law.

Resident 60

The ALJ described how the surveyor observed this cognitively impaired resident in bed, with the head of the bed elevated, in an agitated state and crying out. A roll-belt lap restraint was tied to a non-moveable part of the bed and was placed over the resident's chest. It is undisputed that manufacturer's instructions advised that the restraint be tied only to a moveable part of the resident's bed. The ALJ also noted that Clermont did not contest that the roll-belt was wrongly applied and that staff failed to respond to the resident's cries until a surveyor pushed the call light. He concluded that the improper application created the risk of injury to the resident, notwithstanding facility policy to check restraints every two hours. ALJ Decision at 44-46.

Clermont excepted to FF 22, which reads:

22. Petitioner knew or should have known that a roll-belt was improperly applied to Resident 60 on August 31, 1999 at around 3:15 p.m., because the roll-belt was attached to a non-moveable part of Resident 60's bed, creating a risk of injury to Resident 60.

Id. at 5.

Clermont argued on appeal that (1) it was immaterial whether the waist restraint was affixed to the non-movable bed frame, since the belt would not slide; (2) the surveyors's allegations that the resident cried out for help were not credible as she could not speak; (3) restraints were checked every two hours; and (4) the surveyors were not credible as their documented observations contained inconsistencies. RR at 20.

We find these arguments untenable. The ALJ correctly found that it was undisputed by both parties that the roll-belt was improperly applied "because it was attached to a non-moveable part of the bed." ALJ Decision at 46. Manufacturer safety instructions indicate in no less than four places that the product is to be secured to the movable part of the bedframe. CMS Ex. 65, at 1, 4, 5, and 6. It is also beyond debate that were the bed to be elevated further while the belt was secured across the resident's chest and affixed to a non-moveable part of the bed, injury is reasonably foreseeable. Tr. at 485-87. The ALJ thus reasonably determined that attaching the roll-belt to the non-moveable part of the bed created, at minimum, a risk of accident to the resident. ALJ Decision at 46.

We reject the remainder of Clermont's arguments as both contrary to the evidence of record and irrelevant to the central issue, the uncontested unsafe application of this assistance device.

We thus find that the ALJ's FF 22 is supported by substantial evidence and that there is no error of law.

3. The ALJ did not err in affirming the $650 per day CMP.

The ALJ stated that in appealing the reasonableness of a CMP amount, the facility must provide the ALJ with "evidence or argument" regarding the required regulatory factors at 42 C.F.R. § 488.438(f).

[W]hile the ALJ must consider evidence which is properly presented to him concerning any of the factors listed in 42 C.F.R. § 488.438(f) . . . in evaluating whether the CMP is within a reasonable range, CMS does not automatically have to offer such evidence as part of its prima facie case. Rather, if a facility contends that its financial condition or some other factor makes a CMP unreasonable, then the facility must raise that contention on a timely basis before any question would arise as to CMS's responsibility for producing evidence as to that factor.

ALJ Decision at 48, citing Community Nursing Home, DAB No. 1807, at 22 (2002) and Emerald Oaks, DAB No. 1800 (2001); see also Batavia Nursing and Convalescent Center, DAB No. 1904, at 62 (2004)("As we have held, the ALJ need consider only those factors for which the parties submitted evidence.").

The ALJ then referred to Emerald Oaks at 12-13, for further guidance:

The ALJ is . . . to determine whether the amount of any CMP imposed by CMS and challenged by the facility is within reasonable bounds in light of the purpose of the statute and regulations. If the facility presents evidence relevant to any of the regulatory factors in order to contest the reasonableness of the amount of the CMP, the ALJ is to weigh that evidence, along with all the evidence presented by CMS, in making that determination.

ALJ Decision at 48, quoting Emerald Oaks at 12-13; Coquina Center at 32. After assessing the record evidence concerning the seriousness of the deficiencies, the ALJ found that the CMP imposed by CMS was reasonable, as a result of "two deficiencies involving multiple examples of actual harm." Id. at 49.

Clermont argued on appeal that the CMP was erroneous as the ALJ made a "determination based on pattern and sufficiency of deficiencies that have not been proven." Clermont requested a recalculation of the CMP "[t]o the extent any deficiencies is [sic] reversed as requested herein . . . ." RR at 21. Clermont thus did not argue for a reduction of the CMP amount on any basis other than that the two deficiencies addressed by the ALJ were not supported.

We have affirmed all of the ALJ's determinations, under both deficiencies and supporting examples, as supported by substantial evidence and without legal error. Thus, we reject Clermont's challenge to the CMP amount.

Accordingly, we affirm CLs 10 and 11.

Conclusion

For the above reasons, we affirm the ALJ Decision in its entirety and sustain the CMP (totaling $33,150) imposed in this case. In doing so, we affirm and adopt all FFs and CLs made by the ALJ.

Judith A. Ballard

Celia Sparks Ford

Donald F. Garrett
Presiding Board Member

1. CMS offered its exhibits marked as "HCFA" exhibits. As the agency changed its name from HCFA to CMS in 2001, any reference to a "CMS Exhibit" in this decision shall be construed to refer to an exhibit of the same number marked as a "HCFA Exhibit."

2. A "deficiency" is defined as a skilled nursing facility's "failure to meet a participation requirement" set forth in the Social Security Act (Act) or in 42 C.F.R. Part 483. 42 C.F.R. § 488.301.

3. Surveyors gather information during compliance surveys through personal observation, interviews, and medical record review. SOM Appendix P, Task 5, at P-23 through 26. CMS advises surveyors to document information on forms that include a "Surveyor Notes Worksheet" (HCFA 807) and "Resident Review Worksheet" (HCFA 805). Id. at P-13, 30. CMS explains to surveyors that "[t]his documentation will be used both to make deficiency determinations and to categorize deficiencies for severity and scope." Id. at P-24.

4. This decision may refer to both a facility's Plan of Correction and a resident's plan of care as "POC," as context requires.

5. "The purpose of the remedies is to ensure prompt compliance with program requirements." 42 C.F.R. § 488.402(a).

6. "Seriousness" is assessed by determining "(1) Whether a facility's deficiencies constitute - (i) No actual harm with a potential for minimal harm; (ii) No actual harm with a potential for more than minimal harm, but not immediate jeopardy; (iii) Actual harm that is not immediate jeopardy; or (iv) Immediate jeopardy to resident health or safety. (2) Whether the deficiencies - (i) Are isolated; (ii) Constitute a pattern; or (iii) Are widespread." 42 C.F.R. § 488.404(b).

7. "The absence of culpability is not a mitigating circumstance in reducing the amount of the [CMP]." 42 C.F.R. § 488.438(f)(4).

8. The ALJ Decision correctly states that Level G and H deficiencies require one or more Category 2 remedies (which can include a CMP). ALJ Decision at 11. A Level F deficiency also requires a Category 2 remedy. 42 C.F.R. § 488.408(d),(c); SOM §7400E.1. CMS is required to select a Category 1 remedy for Level D and E deficiencies. Id.

9. Substandard quality of care is defined as "one or more deficiencies related to participation requirements under § 483.13, Resident behavior and facility practices, § 483.15, Quality of life, or § 483.25, Quality of care of this chapter, which constitute either immediate jeopardy to resident health or safety; a pattern of or widespread actual harm that is not immediate jeopardy; or a widespread potential for more than minimal harm, but less than immediate jeopardy, with no actual harm." 42 C.F.R. § 488.301.

10. The ALJ Decision erroneously reflects a total of 23 deficiencies in the CMS 2567, rather than 25. ALJ Decision at 10.

11. The ALJ stated that his analysis focused "only on those deficiencies alleged by CMS to be most severe." ALJ Decision at 10. As noted, the severity of a deficiency, along with its scope, determines its seriousness. CMS assessed the seriousness of F-Tags 314 and 324 at Levels G and H. It is thus apparent that the ALJ focused his analysis on the most serious deficiencies that caused actual harm to residents that was not immediate jeopardy.

12. The ALJ noted that Clermont presented no evidence at the hearing on its purported inability to pay the CMP and did not pursue the issue in its post-hearing briefs. ALJ Decision at 47.

13. See "Request for Review of Petitioner from Decision CR-1087, Rendered by Administrative Law Judge on September 25, 2003," for Docket No. C-00-340, Decision No. CR1087, and dated November 28, 2003.

14. The Board advised Clermont counsel Eric Hershberger on Tuesday, April 6, 2004, that there was no reply brief from Clermont in the case file. Mr. Hershberger stated that he would advise the Board whether one had been filed on Clermont's behalf. As of the date of this decision, the Board has received no follow-up response. We thus decide this case on Clermont's Request for Review, CMS's Response brief, and the record before the ALJ.

15. Clermont's citations to the record here fail to support its argument. CMS Exhibit 1, at 36 concerns Resident 168, not 171. CMS Exhibit 31, at 19 is a Post Skin Wound Summary dated September 1, 1999, after the surveyor's August 31 observation, and is thus irrelevant. The cited testimony concerns a yeast infection in Resident 171's mouth, not the pressure sore at issue. Petitioner's Exhibit 6, at 13 refers to treatments for the resident's right thigh, left armpit, mid sternum, and right tibia and fibula, but not the outer left ankle.

16. Clermont's argument that the chair pad would not have helped the resident's pressure sores is inconsistent with including it on both the facility's Plan of Care for Preventive Skin Care and Plan of Correction. Id. at 26, citing P. Ex. 22, at 3; CMS Ex. 1, at 36.

17. The POC reflects turning every two hours, with right and left turns, but not back turns. P. Ex. 17, at 27. It is undisputed that the resident was turned onto her back and left there for at least two hours. CMS Ex. 52, at 6, 8.

18. "Neglect" is defined as "the failure to provide goods and services necessary to avoid physical harm, mental anguish, or mental illness." 42 C.F.R. § 488.301.

19. While the ALJ correctly stated that an accident need not occur for a violation to exist, he later said that as the first prong of the prima facie case, CMS must present evidence that an accident occurred (with or without resident injury). ALJ Decision at 30. We view this misstatement as inadvertent and harmless, given his prior and correct statement of the law concerning accident risk.

20. The ALJ quoted from Odd Fellow to the effect that a facility "must do everything in its power to prevent accidents." ALJ Decision at 29 (citations omitted). In a case decided after the ALJ Decision, the Board noted that this phrase "does not track the wording of the regulation," which sets a standard of adequate supervision and assistive devices. Windsor Health Care Center, DAB No. 1902, at 5 n.3 (2003), citing Woodstock. As we noted in Windsor, however, it is clear that the ALJ utilized the appropriate regulatory standard in his analysis. Id.

21. Clermont relied upon a selective excerpt from Gold Country Health Center v. HCFA, CR533 (1998) to establish that risk to resident health or safety is an insufficient basis for a violation of "any given participation requirement." RR at 13-14. However, Gold Country is inapposite, focusing on a resident's right to have access to, and receive information from, a state ombudsman's office under 42 C.F.R. § 483.10(g)(2). Id. at 75.

22. The evidence (July 30 nurse's note) is sufficient to show that Clermont was aware of the need for the two side rails prior to the fall. Other than this note, there is no evidence that Clermont took any steps to meet this need prior to the fall.

23. The fact that the ALJ erroneously cited the surveyor's record review at CMS Exhibit 25 is of no consequence, since Clermont has shown no prejudice to its ability to have reviewed the surveyor's recorded observations at CMS Exhibit 29.

24. Even if this issue could properly be raised on appeal (and it cannot), Surveyor Dunn's testimony is consistent with her observations recorded in CMS Exhibit 29. CMS Ex. 29, at 11 (8/31, "Informed staff the [restraint free alarm] was not on. Staff verified it was off . . . ."), 21 ("Alarm is off. Shared [with] staff prior to leaving the resident.").

25. The hearing transcript erroneously cites to Ms. Dunn's recorded observations as CMS Exhibit 29, at 52.

26. The ALJ referred to a "clip and tether" alarm, which would clip to the resident's clothing and snap free if the resident leaned too far forward, thereby setting off the alarm. ALJ Decision at 43.