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CASE | DECISION | ANALYSIS | JUDGE | FOOTNOTES

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


SUBJECT: Livingston Care Center,

Petitioner,

DATE: March 24, 2003

             - v -
 

Centers for Medicare & Medicaid Services

 

Docket No. A-03-7
Civil Remedies CR906
Decision No. 1871
DECISION
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FINAL DECISION ON REVIEW OF
ADMINISTRATIVE LAW JUDGE D
ECISION

Livingston Care Center (Livingston) appeals a May 22, 2002 decision by Administrative Law Judge (ALJ) Steven T. Kessel granting summary judgment for the Centers for Medicare & Medicaid Services (CMS) and upholding a $500 per day civil money penalty (CMP) for failure to comply substantially with the Medicare participation requirement in 42 C.F.R. § 483.25(c). Livingston Care Center, DAB CR906 (2002) (ALJ Decision). The CMP upheld by the ALJ totalled $10,500 ($500 per day for the 21 days from April 20 to May 11, 2001).

We agree with the ALJ that CMS presented a prima facie case that Livingston was not in substantial compliance with 42 C.F.R. § 483.25(c) during the relevant survey, and that Livingston failed to raise a genuine issue of material fact concerning that prima facie case. We also find substantial evidence in the record to support the ALJ's finding that the amount of the CMP was reasonable. For this and other reasons, we affirm the ALJ Decision in its entirety and sustain the CMP of $10,500.

Background

A. Regulatory Background

Livingston is a skilled nursing facility that participates in the Medicare program. Medicare's participation requirements for nursing and other long-term care facilities are set forth in 42 C.F.R. Part 483.

A facility's compliance with participation requirements is verified through the survey and certification process described in 42 C.F.R. Part 488, Subpart E. Surveys are usually conducted by a state agency under an agreement with CMS. A survey's findings are presented in a Statement of Deficiencies, which identifies each violation of (or instance of noncompliance with) a participation requirement. See CMS State Operations Manual (SOM) Appendix P, ch. IV. Deficiencies are identified by the survey agency using "tags" that correspond to the participation requirements in 42 C.F.R. Part 483. Id.

If a survey reveals that a facility is not in "substantial compliance" with federal participation requirements, the facility must submit a plan of correction (POC) for approval by the survey agency. 42 C.F.R. §§ 488.402(d), 488.408(f). Even if the POC is approved, 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 § 7316. "Substantial compliance" is defined in the regulations 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.

A CMP in the range of $50-$3,000 per day may be imposed for deficiencies that do not constitute "immediate jeopardy," but either cause actual harm or create the potential for more than minimal harm. 42 C.F.R. § 488.438(a)(2). A 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).

B. The Surveys

On April 16-20, 2001 the Ohio Department of Health (ODH) conducted a survey of Livingston. CMS Ex. 12, at 2. As a result of this survey (the "April survey"), ODH found Livingston to be in noncompliance with several participation requirements, including the requirement in 42 C.F.R. § 483.25(c) that a facility prevent and adequately treat pressure sores. CMS Ex. 1. The alleged violations of section 483.25(c), identified in the Statement of Deficiencies under Tag F314, concerned six residents (Residents 83, 73, 90, 1, 20, and one other resident whose care is not at issue here). Id. ODH determined that the deficiencies cited under Tag F314 constituted "level H" noncompliance, which is noncompliance that causes "actual harm" but not "immediate jeopardy." SOM § 7400(E); CMS Ex. 1, at 13.

On May 1, 2001, ODH reported its survey findings to CMS. CMS Ex. 2. On May 11, 2001, ODH conducted a revisit survey and found that Livingston was in substantial compliance with federal participation requirements as of that date. CMS Ex. 4, at 1; CMS Ex. 6.

On May 22, 2001, CMS notified Livingston that the deficiencies cited by ODH under tag F314 constituted a "substandard quality of care" (1) as well as a "pattern" of noncompliance that caused harm to residents. CMS Ex. 4. Based on those deficiencies, CMS imposed a $500 per day CMP that accrued from April 20 until May 11, 2001. Id. Because it found that Livingston had provided a "substandard quality of care," CMS also prohibited Livingston from offering or conducting nurse aide training or competency evaluations for two years. Id. at 2.

C. The ALJ Proceedings

After engaging in informal dispute resolution, Livingston appealed the CMP by requesting an ALJ hearing. CMS responded with a motion for summary judgment. In support of its motion, CMS submitted various documents, including the declarations of three ODH employees -- Alice Cox, April Gilmore, and Misty Martin -- who conducted the April survey. See CMS Exs. 12-14. These declarations were supplemented by facility records, surveyor notes, and other documentation of the April survey. CMS also submitted the facility records attached to Livingston's request for informal dispute resolution (IDR). See CMS Ex. 7.

In response to the summary judgment motion, Livingston submitted a brief and the declaration of Kinda Walden, a certified wound ostomy and continence nurse, who stated that she was present during the April survey. Relying in part on the Walden Declaration and on documents attached to its request for IDR, Livingston argued that disputed issues of material fact existed with respect to the deficiencies involving Residents 83, 73, 90, 1, and 20. Livingston also argued that the amount of the CMP imposed by CMS was unreasonable.

Rejecting Livingston's contentions, the ALJ entered summary judgment for CMS and upheld the $500 per day CMP. In doing so, the ALJ made the following six Findings of Fact and Conclusions of Law (FFCLs): (1) summary judgment was appropriate because there were no genuine issues of material fact concerning CMS's allegations that Livingston was not in substantial compliance with a Medicare participation requirement during the April survey (ALJ Decision at 4); (2) undisputed facts established that Livingston violated 42 C.F.R. 483.25(c) in its care and treatment of Residents 83, 73, 90, 1, and 20 (id. at 7-21); (3) Livingston offered no evidence to dispute CMS's assertion that it failed to achieve substantial compliance with Medicare participation requirements until May 11, 2001 (id. at 22); (4) the amount of the CMP was reasonable (id.); (5) because it was not challenging its loss of authority to conduct nurse aide training, Livingston did not have the right to dispute CMS's finding that it provided a "substandard quality of care" (id. at 25); and (6) CMS's motion for summary judgment as to alleged Life Safety Code violations was moot (id. at 26).

Issues

Livingston's request for review (RR) addresses FFCLs one through five. First, Livingston contends that summary judgment was improper because 42 C.F.R. Part 498 requires the ALJ to conduct an in-person hearing. RR at 5. Second, it contends that disputed issues of material fact exist with respect to the deficiencies involving Residents 83, 73, 90, 1, and 20. Id. at 8-23. Third, it challenges the ALJ's finding that substantial compliance did not occur until May 11, 2001. Id. at 23. Fourth, it contends that the ALJ erred in finding the amount of the CMP reasonable. Id. Fifth, it discusses the ALJ's finding that it had no right to challenge CMS's determination that it provided a "substandard quality of care." Id. at 24.

Standard of Review

Our standard of review on a disputed conclusion of law is whether the ALJ Decision is erroneous. Our standard of review on a disputed finding of fact is whether the ALJ's finding is supported by substantial evidence on the record as a whole. See Guidelines for Appellate Review of Decisions of Administrative Law Judges Affecting a Provider's Participation in the Medicare and Medicaid Programs, ¶4(b), http://www.hhs.gov/dab/guidelines/ prov.html. Whether summary judgment is appropriate is a legal issue that we address de novo, viewing the proffered evidence in the light most favorable to the non-moving party. See Crestview Parke Care Center, DAB No. 1836 (2002). Although the Federal Rules of Civil Procedure are inapplicable in this administrative proceeding, we are guided by those rules and the judicial decisions interpreting them in determining whether the ALJ's use of summary procedures was proper. See Thelma Walley v. Inspector General, DAB No. 1367 (1992); Birchwood Manor Nursing Center, DAB No. 1669 (1998).

Summary judgment is appropriate when the record shows that there is no genuine issue as to any material fact, and the moving party is entitled to judgment as a matter of law. See Celotex Corp. v. Catrett, 477 U.S. 317, 322-25 (1986). The party moving for summary judgment bears the initial burden of demonstrating that there are no genuine issues of material fact for trial and that it is entitled to judgment as a matter of law. Celotex, 477 U.S. at 323. This burden may be discharged by showing that there is no evidence in the record 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 (moving party is entitled to summary judgment if the party opposing the motion "fails to make a showing sufficient to establish the existence of an element essential to that party's case, and on which that party will bear the burden of proof at trial").

Under the applicable substantive law, CMS has the initial burden of coming forward with evidence that the provider was not in substantial compliance with Medicare participation requirements. However, the provider bears the ultimate burden of persuading the ALJ that it was in substantial compliance with those requirements. See South Valley Health Care Center, DAB No. 1691 (1999), aff'd, South Valley Health Care Center v. HCFA, 223 F.3d 1221 (10th Cir. 2000). Consequently, 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 Livingston was not in substantial compliance with one or more 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 Livingston has proffered evidence that would permit an ALJ to conclude that it was in substantial compliance with Medicare participation requirements during the relevant period.

ANALYSIS
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Issue 1: Whether Livingston is entitled to an in-person hearing under 42 C.F.R. Part 498 (FFCL 1).

Under FFCL 1, the ALJ made a general finding that Livingston was not entitled to a hearing because it failed to show that there was a genuine dispute of material fact under the summary judgment standard. ALJ Decision at 4-7. Livingston challenges this finding, contending that the regulations in 42 C.F.R. Part 498 entitle it to an in-person hearing before the ALJ. RR at 6. Absent a waiver, says Livingston, "an oral hearing is required [by Part 498] unless the 'affected party either had conceded all of the material facts or proffered testimonial evidence only on facts which, if proved, clearly would not make any substantive difference in the results.'" Id. at 7 (emphasis in original)(quoting Glenburn Home, DAB No. 1806 (2002)). Livingston asserts that it has neither conceded all of the material facts nor proffered testimony only on nonmaterial facts. Id. It also asserts that the ALJ "erred in granting summary affirmance to CMS because he made an incorrect and practical distinction between facts and conclusions," and that an ALJ "[may not] deny an affected party's right to an oral hearing and then proceed to weigh disputed facts." Id. at 7-8.

We agree with the ALJ that Livingston was not entitled to an in-person hearing. We held in Crestview Parke Care Center that, notwithstanding the regulations in 42 C.F.R. Part 498, the ALJ may decide a case on summary judgment, without an evidentiary hearing, if there is no dispute about any material fact and a party is entitled to judgment as a matter of law. In this case, CMS furnished the ALJ with evidence of several violations of the Medicare participation requirement in 42 C.F.R. § 483.25(c), evidence sufficient to warrant a judgment that Livingston was not in substantial compliance with Medicare participation requirements during the April survey. As we explain in detail in the next section, despite having ample opportunity, Livingston failed to dispute any of the material facts supporting CMS's allegations of noncompliance. Our decision in Glenburn Home, upon which Livingston relies, makes it clear that a hearing is not required if, as happened here, the non-moving party concedes or fails to dispute the material facts. (2) Consequently, we conclude that Livingston was not entitled to an evidentiary hearing.

To the extent that Livingston's contentions regarding FFCL 1 relate to the ALJ's application of the summary judgment standard to particular allegations of noncompliance, we address those contentions in the next section. In general, though, we find that the ALJ did not "weigh" or draw conclusions from disputed facts. As his decision makes plain (at pages 7-21), the ALJ simply considered whether CMS's evidence was controverted and whether the uncontroverted material evidence entitled CMS to judgment as a matter of law, an analysis consistent with the applicable summary judgment standard.

Issue 2: Whether the ALJ erred in granting summary judgment for CMS concerning violations of 42 C.F.R. § 483.25(c) involving Residents 83, 73, 90, 1, and 20.

As indicated, the basis for the CMP in this case is CMS's determination that, during the April survey, Livingston was in violation of 42 C.F.R. § 483.25(c) with respect to five residents. Section 483.25(c) requires a long-term care facility to 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.

In assessing whether summary judgment was proper, we discuss CMS's allegations regarding each of the five residents whose care was found by surveyors to be deficient. We begin that discussion by identifying ODH's deficiency finding. We then set out the facts and evidence in the record before the ALJ, followed by an assessment of the ALJ's findings and Livingston's contentions on appeal. As explained below, we find that Livingston has failed to create a genuine dispute of material fact concerning any of the violations alleged by CMS, and that the undisputed facts are sufficient to establish that Livingston's care of Residents 83, 73, 90, 1, and 20 was not in substantial compliance with Medicare participation requirements during the April survey. (3)

(i) Resident 83

ODH found that Livingston had failed to furnish Resident 83 with pressure-reducing surfaces prescribed for her, and that Resident 83 had recently developed three avoidable pressure sores (on the buttock, foot, and left leg). CMS Ex. 1, at 14-16.

The following facts are undisputed: Resident 83 had peripheral vascular disease and other conditions that made her vulnerable to pressure sores. To address this vulnerability, the plan of care called for Livingston to provide her with a pressure-reducing mattress and wheelchair cushion. CMS Ex. 12, at 28. The survey agency also reported that Resident 83 had a "pathological left distal femur fracture," for which an emergency room doctor had prescribed a left knee immobilizer in early March 2001. CMS Ex. 1, at 14, 21.

In the Statement of Deficiencies (CMS Ex. 1 at 14-16), ODH indicated that it had found or observed the following about Resident 83 during the April survey:

  • Resident 83 had a pressure sore on the right heel which a physician had determined was directly related to her peripheral vascular disease and unavoidable. CMS Ex. 1, at 14.
  • On April 16 at 8:30 a.m. and on April 17 at 9:35 a.m., Resident 83 was seen in bed with a standard mattress but no pressure-reducing mattress.
  • On April 16 at 8:30 a.m. and 11:45 a.m., and on April 17 at 9:35 a.m., 10:20 a.m., and 12:26 p.m., Resident 83 was seen, near her bed or in the dining hall, sitting in a wheelchair without a pressure-reducing cushion.
  • On April 16 at 12:20 p.m., the surveyor and a Livingston nurse discovered a previously unidentified pressure sore on the left buttock.

  • On April 16 at 12:20 p.m., the surveyor observed a urinary catheter drainage tube entering the top and exiting from the bottom of Resident 83's left knee immobilizer. The tube was positioned inside the immobilizer and was pressing on her leg. The tube left an imprint on her leg from the knee to below the knee. There was a dressing on the left leg below the knee and over the fibula. A brown foul-smelling drainage leaked from the dressing. The dressing was removed to reveal a stage II pressure sore. The sore was located at the site where the metal rod from knee immobilizer had been pressing on the tissue over the bone. There was no cushion in the immobilizer to protect the resident's tissues from pressure. Nursing records indicated that this pressure sore had been found 10 days before, on April 6. However, the wound's characteristics were not noted in Resident 83's chart, and there was no documentation of any plan to treat or halt the progression of the wound. In addition, there was no indication that her physician had been notified of the wound until April 16 (following the surveyor's observations). Finally, there was "no intervention to modify the pressure from the metal rod . . . which continued to be applied directly over the Stage II open sore" (CMS Ex. 1 at 15).

  • An April 5 progress note indicated that Resident 83 had a red area on the top of her right foot. On April 18, a Livingston skin specialist identified a Stage II pressure sore at the same site. There was no record of any attempt to address the right foot redness discovered on April 5, or of the steps taken to prevent this skin problem from becoming a pressure sore.

In her declaration, Alice Cox, the surveyor who observed Resident 83, stated that Karen Paxton, a Livingston nurse responsible for pressure sore treatment, had accompanied her at all times on April 16. CMS Ex. 12, at 3. Surveyor Cox also stated that Nurse Paxton "witnessed and confirmed" her reported observations, "including the observations that [Resident 83] had a standard mattress and no cushion to relieve pressure on her wheelchair." Id.

The ALJ found that Resident 83 was at risk of developing pressure sores and that Livingston: (1) failed to furnish her with a pressure-reducing bed mattress and wheelchair cushion, as required by her plan of care; (2) knew on April 6, 2001 that pressure from the knee immobilizer had caused a pressure sore on her left leg but waited at least 10 days to develop a plan to address the problem; and (3) "waited 13 days after identifying a problem with the resident's right foot before addressing that problem." ALJ Decision at 10-11. Based on these findings, the ALJ concluded that Livingston had failed to provide necessary care to promote healing of pressure sores and to prevent new sores from developing, as required by section 483.25(c)(2). Id. at 10. The ALJ also determined that Livingston had failed to proffer evidence disputing any of the material facts averred by CMS. Id. at 10-14. Consequently, the ALJ concluded that CMS was entitled to summary judgment with respect to the allegations involving Resident 83. Id. at 14.

We affirm the ALJ's conclusion regarding Resident 83 in part because the request for review fails to discuss certain alleged findings that, by themselves, establish that Livingston failed to comply with section 483.25(c)(2). These deficiencies concern the pressure sore on Resident 83's left leg and and the skin redness on the right foot that ultimately resulted in a pressure sore. As indicated, CMS submitted evidence that Livingston failed to treat these problems when they arose. Livingston does not assert that this evidence was, on its face, insufficient proof of substantial noncompliance with section 483.25(c). Nor does Livingston contend that it controverted CMS's evidence concerning its failure to treat the left leg and right foot. Indeed, the evidence proffered by Livingston ignores these aspects of CMS's prima facie case concerning Resident 83. For example, Livingston's witness, Kinda Walden, did not describe the steps taken, if any, to prevent the red area on Resident 83's right foot from becoming a pressure sore. Her declaration does contain various statements about the leg sore, but these statements focus on the unavoidability of the sore and not on how it was treated prior to the survey. See Walden Decl. at 6. In fact, Livingston proffered no evidence that it created a timely plan for treating the leg sore, which the nursing staff first discovered 10 days prior to the April survey. For these reasons, we conclude that Livingston has failed to raise a genuine issue of material fact regarding its treatment of Resident 83's leg and foot sores.

Livingston's contentions on appeal focus on other aspects of CMS's case, but they likewise fail to show a genuine dispute concerning a material fact. For example, Livingston asserts that all of Resident 83's pressure sores were unavoidable. RR at 11. However, its witness, Kinda Walden, addresses only the conditions that resulted in the left leg sore. No attempt was made to show that the other pressure sores (on the right foot and buttock) were unavoidable. Even if those sores were unavoidable, Livingston was still required by the regulations to provide appropriate care and treatment to promote healing, prevent infection, and prevent new sores. Livingston does not say whether or how it satisfied this obligation.

With respect to the pressure sore on Resident 83's left leg, Ms. Walden asserted that use of the knee immobilizer created a risk of skin breakdown. Walden Decl. at 6. Ms. Walden also stated that, after assessing the risk, "numerous health care professionals" made a "difficult and thought out" decision to use the immobilizer because "further trauma to the leg was a more immediate risk." Id. However, Ms. Walden did not indicate when this decision was made. More important, none of the supporting records she cited (CMS Ex. 7, at 26-32) indicate that Resident 83's caregivers considered the risk of skin breakdown at the time the decision was made to use the immobilizer. See CMS Ex. 7, at 26-32. The only clinical record that discusses the problem is a nursing summary dated April 23, 2001. CMS Ex. 7, at 30-31. Given that it was prepared three days after the survey, this document is little more than a post hoc justification for Livingston's treatment (or lack thereof) of Resident 83's left leg sore. (4) Moreover, we note that the nursing summary does not address whether the facility considered whether there were feasible measures to mitigate the harm caused by the knee immobilizer.

Livingston also takes issue with the ALJ's finding that it failed to provide a pressure-reducing mattress. RR at 9. This finding was based on the observations of Surveyor Cox, who confirmed in her declaration that she saw Resident 83 without a pressure-reducing mattress. CMS Ex. 12, at 3 ¶ 8. Livingston's response to this evidence is a statement from Kinda Walden that she "[could not] confirm the surveyor's observations of the mattress on R.83's bed" without additional information from the surveyor about the color of the mattress. Walden Decl. at 5. Ms. Walden also stated that a standard mattress and a pressure-reducing mattress look "very much" alike, and that "the color difference . . . is the key to being able to confirm whether it was a standard one or not." Id. In our view, these statements, even if viewed in a light favorable to Livingston, do not create a genuine factual dispute. The apparent purpose of Ms. Walden's statements is to challenge the accuracy of the survey findings. However, they fail to achieve this purpose in part because Ms. Walden did not positively assert that Resident 83 had a pressure-reducing mattress (or, for that matter, any particular kind of mattress) on the date of the survey. Moreover, Ms. Walden ignored Surveyor Cox's sworn statement that she had received verbal confirmation from Nurse Paxton, Livingston's pressure sore nurse, that Resident 83's bed had only a standard mattress. Livingston does not deny that Surveyor Cox received such a confirmation from Nurse Paxton. For these reasons, we agree with CMS that Ms. Walden's statements are tantamount to pleading denials, which are insufficient to create a genuine issue of material fact. Matsushita, 475 U.S. 586, n.11.

Finally, Livingston suggests that it created a genuine issue of material fact concerning Surveyor Cox's five separate observations of Resident 83 in her wheelchair without a pressure- relieving cushion. RR at 10. Kinda Walden states that the "cushion would have been removed because of the treatment to R.83's leg." Walden Decl. at 5. However, Ms. Walden did not say why Resident 83's leg treatment (presumably she was referring to the immobilizer) necessitated removal of the cushion. Nor did Livingston deny that the plan of care continued to require the chair cushion even after the leg treatment was initiated. Instead, while not denying that Resident 83 lacked a chair cushion, Livingston questioned whether Surveyor Cox could have seen Resident 83 in the chair at the times specified, citing a treatment log which instructed the nursing staff on each shift to circle his or her initials if Resident 83 was not up in her chair. CMS Ex. 7, at 10.

For the two days in question -- April 16 and 17 -- the notations on the treatment log for each shift indicate that Resident 83 was not up in her chair. Whether this means that she was bed-bound for the entire shift, as Livingston would have us believe, is unclear. The notations may, in fact, reflect nothing more than momentary periodic observations, with no accounting for her positioning or whereabouts in the periods between those observations. Livingston offered no testimony interpreting the notations, and it did not attempt to rule out the possibility that Resident 83 might have been out of bed for part of the day on April 16 and 17. Given these evidentiary gaps and Livingston's failure to deny CMS's allegation that Resident 83's wheelchair lacked a pressure-reducing cushion, a rational trier of fact could not reasonably conclude that Livingston had met its obligation under the plan of care to furnish that item.

For the foregoing reasons, we affirm the ALJ's finding that Livingston violated section 483.25(c) in its care of Resident 83.

(ii) Resident 73

ODH found that Livingston violated section 483.25(c) by failing to provide Resident 73 with timely continence care. CMS Ex. 6, at 17.

The following facts are undisputed. Resident 73's medical problems included spinal stenosis, obesity, and suspected Parkinson's disease. CMS Ex. 7, at 50. A March 5, 2001 minimum data set evaluation indicated that she was frequently incontinent of urine, was totally dependent on others for her personal needs, and was at risk for skin impairment due to incontinence and dependency. CMS Ex. 1, at 16-17. Accordingly, the plan of care called for the nursing staff to reposition and toilet her every two hours and to keep her skin clean and dry. CMS Ex. 13, at 20, 21. At the time of the April survey, Resident 83 had a stage II pressure sore on the right buttock. CMS Ex. 13, at 4 ¶ 9; CMS Ex. 6, at 16, 22; RR at 14.

The Statement of Deficiencies indicates that Surveyor April Gilmore went to Resident 73's room on April 18 at 7:45 a.m., accompanied by Livingston employees, and observed the following: the pad underneath Resident 73 was soiled with urine; her buttocks and upper legs were moist with urine; and her buttocks and bed linen had a urine odor. CMS Ex. 6, at 16-17; CMS Ex. 13, at 4. The Statement of Deficiencies also states that Resident 73 was left to eat breakfast in her urine-soaked bed and did not receive perineal care and a change of bed sheets until 9:30 a.m. on April 18. CMS Ex. 6, at 16-17. In addition, the Statement of Deficiencies indicates that Surveyor Gilmore returned to the room at 1:20 p.m. and noticed that Resident 73 was again wet with urine. Id. At that time Resident 73 stated that she did not know when she had urinated or whether her bed was wet. Id. at 17.

In her declaration, Surveyor Gilmore stated that Livingston employees Karen Paxton and Kinda Walden were present when she observed Resident 73 on April 18. CMS Ex. 13, at 4 ¶¶ 9-10. Surveyor Gilmore also stated that she observed Resident 73 lying in bed for more than two hours on April 17 without being repositioned or checked for incontinence. Id. at 5 ¶ 10.

In response to CMS's evidence, Kinda Walden stated:

The "pressure sore" on R. 73's buttocks . . . was a skin on skin pressure area that developed unavoidably at Livingston. [Resident 73] is an extremely large woman with folds of flab all over her body, including her buttocks. She sweats constantly and profusely. She is so large and medically complicated, she can only sleep while lying on her back. It is impracticable to prevent small and minor pressure areas caused by skin on skin contact from folds of flab on this resident's buttocks.

Walden Decl. at 9. In addition, Ms. Walden stated that Resident 73 received "planned interventions and services to prevent further skin breakdown," including moisture barrier cream applied to her buttocks, and that she received "all care and services as stated in the plan of care." Id. at 8, 9.

The ALJ found that CMS had proffered evidence establishing that Livingston had failed to implement instructions in the plan of care to provide Resident 73 with necessary and timely continence care. ALJ Decision at 15. In particular, the ALJ found that Livingston allowed Resident 73 to lie for nearly two hours in a urine-soaked bed on April 18, 2001 without being cleaned. Id. The ALJ also found that Resident 73 had been allowed to lie for more than two hours on April 17 without being repositioned or checked for incontinence. Id. In addition, the ALJ found that "[p]etitioner's staff not only failed to prevent episodes of incontinence, but it failed to respond promptly to those episodes," exposing the pressure sore on Resident 73's right buttock to urine. Id. Finally, the ALJ found that Livingston failed to dispute the material facts, noting that it had "offered no facts to challenge the accuracy of the surveyor's findings" and proffered no evidence that would refute CMS's allegation that it failed to implement Resident 73's plan of care. Id. at 15-16.

We agree with the ALJ that CMS's evidence is sufficient to establish that, during the April survey, Livingston was not in substantial compliance with section 483.25(c) with respect to Resident 73. CMS submitted evidence that on April 18, Livingston failed to toilet or reposition Resident 73 every two hours, as called for in the plan of care, exposing her skin and a pre-existing pressure sore to urine. Livingston does not assert that the two-hour bed checks were unnecessary, that it actually performed the required two-hour bed checks on the days in question, that it did not allow Resident 73 to lie in a urine-soaked bed for almost two hours, or that its omissions presented no more than a risk of minimal harm.

Livingston's chief contention, it appears, is that the pressure sore on Resident 73's buttock was clinically unavoidable. RR at 14. However, Livingston was not cited for failing to prevent this pressure sore. Instead, it was cited for failing to provide the care and services necessary to promote healing, prevent infection, and prevent other pressure sores from forming. Livingston does not deny that its documented failure to provide prescribed continence care constitutes a failure to comply with section 483.25(c).

In her declaration, Ms. Walden asserts that Livingston provided all of the care and services called for in Resident 73's plan of care. The declaration makes it clear that Ms. Walden was not relying on her personal knowledge for this assertion but on other evidence. The evidence she cited (CMS Ex. 7, at 1-9), even if viewed in the light most favorable to Livingston, does not rebut the surveyor's observations that Resident 73 was not toileted at regular intervals or kept clean and dry as called for in the plan of care. In addition, Livingston does not deny that Resident 73 was left for almost two hours in a urine soaked bed between 7:45 a.m. and 9:30 a.m. on April 18.

Kinda Walden suggested that Resident 73 was "resistive to care" and refused to comply with her treatment plan. See Walden Decl. at 8. However, none of the documents she cited to support this contention (CMS Ex. 7, at 5-9) indicate that Resident 73 refused care regularly, refused perineal care when it was needed, or refused care on the days of the survey. (5)

Kinda Walden also suggested that the observations made by Surveyor Gilmore were not reliable or accurate because a "worksheet" (CMS Ex. 13, at 35) describing the observations of Resident 73 contains patient information about another (male) patient. See RR at 15-16 & n.9. CMS does not respond to this assertion. However, we note that Ms. Gilmore typically recorded observations about more than one resident on a single worksheet. We also note that Livingston has provided us with no basis to conclude that her observations about Resident 73 were unreliable or inaccurate because of that practice. See, e.g., CMS Ex. 13, at 33, 35.

In a brief footnote, Livingston makes other arguments regarding the surveyor's observations. See Request for Review at 16 n.10. These arguments are not well-developed, allege only insignificant or inconsequential problems with CMS's evidence, and therefore do not persuade us that there are material facts in dispute regarding Resident 73.

Because the record discloses no genuine dispute about the material facts supporting CMS's prima facie case, we affirm the ALJ's conclusion that, during the April survey, Livingston was not in substantial compliance with section 483.25(c) in its care of Resident 73.

(iii) Resident 90

With respect to Resident 90, ODH determined that Livingston had "failed to provide the needed pressure relief to prevent the development of pressure sores and to promote healing of pressure sores." CMS Ex. 1, at 19.

The following facts are undisputed. Resident 90 was dependent on the nursing staff for her personal needs and was at risk for skin impairment. CMS Ex. 11, at 42. Her plan of care required that she have a pressure-reducing mattress and wheelchair cushion. Id. On April 9 (one week before the survey), Resident 90 had a blister on her right heel. See RR at 17-18; CMS Ex. 13, at 9.

In the Statement of Deficiencies (CMS Ex. 1), ODH reported the following: on April 16 at 8:40 a.m., Resident 90 was seen in bed without a pressure-reducing mattress. She had padded bed boots on both feet, which were not elevated. On April 17, she was again seen in bed without pressure relief. Her heels were on the surface of the bed. The right heel was unwrapped, revealing a wound. A physician who was present determined that the wound -- which was open, red, and bleeding -- was a Stage II pressure sore. Resident 90 also had a "dark red Stage I area" on the bony prominence of the right metatarsal. Later that day, at 5:05 p.m., she was seen by the surveyor (April Gilmore) sitting in a geri-chair with her heels flat on the surface of the chair. The chair had no pressure-reducing cushion. See CMS Ex. 1, at 18-19.

In her declaration, Surveyor Gilmore confirmed that she saw Resident 90 on April 16 and 17 lying in bed without pressure relief. CMS Ex. 13, at 3. Surveyor Gilmore also stated that she saw Resident 90 sitting in a geri-chair without a pressure-reducing cushion with her heels flat on the chair's surface. Id.

The ALJ found that CMS's evidence concerning the absence of pressure relief on Resident 90's bed and chair was not disputed by Livingston and established that Livingston violated section 483.25(c). ALJ Decision at 17.

In its request for review, Livingston does not dispute that Resident 90 was not using prescribed pressure-reducing surfaces during the April survey. Nor does Livingston challenge CMS's contention that its failure to provide Resident 90 with pressure relief was a violation of section 483.25(c). In addition, Livingston does not assert that such violation caused only minimal harm or the potential for no more than minimal harm to Resident 90. We therefore agree with the ALJ that Livingston did not dispute any material fact regarding this resident's care and treatment.

Livingston's contentions on appeal do not persuade us otherwise. Livingston contends, for example, that a physician "had been carefully monitoring Resident #90's skin care needs and did not feel that a pressure-reducing mattress was needed." RR at 19; see also Walden Decl. at 7. However, the medical records it cites (CMS Ex. 7, at 58-61) do not confirm this assertion. The plan of care in effect at the time of the survey required the facility to provide a pressure-reducing mattress, and Livingston submitted no evidence that these instructions were ever changed. See CMS Ex. 13, at 11.

Relying on Kinda Walden's professional opinion (Walden Decl. at 7), Livingston contends that the wound on Resident 90's right heel was a burst blister, not a pressure sore. RR at 18. Whether the right heel had a pressure sore is a disputed fact. (6) However, it is not a disputed material fact because Livingston's failure to provide pressure-reducing surfaces is sufficient to establish a violation of section 483.25(c)'s requirement that a facility provide necessary care to prevent new sores from developing. See Crestview Park Care Center (to defeat a motion for summary judgment, the opposing party must create a dispute about a fact whose existence or nonexistence would affect the outcome of the case).

Livingston also contends that it complied with Dr. Nagle's April 17 order to provide Resident 90 with Herbst Cradle boots, presumably to treat or prevent pressure sores on her feet and heels. RR at 19; see also Walden Decl. at 7. However, the steps Livingston took during or after the survey with respect to her lower extremities cannot obscure the undisputed fact that Livingston had not furnished Resident 90 with pressure-reducing surfaces pursuant to her plan of care. As such, Livingston's alleged compliance with the April 17 physician's order does not create a genuine issue of material fact.

Finally, Livingston suggests that it did not violate section 483.25(c) because its omissions caused no actual harm. However, a showing of actual harm is not necessary to support a deficiency finding and enforcement action under the regulations. See Lake City Extended Care Center, DAB No. 1658 (1998). A facility is subject to enforcement action when there is evidence that it is, or was, not in "substantial compliance" with participation requirements. 42 C.F.R. § 488.330(b), 488.430. A facility is not in substantial compliance if its acts or omissions either cause actual harm or create the potential for causing more than minimal harm. (7) 42 C.F.R. § 488.301, 488.408. As indicated, Livingston did not allege or prove that its failure to provide pressure relief created the potential for only minimal harm.

For the foregoing reasons, we affirm the ALJ's finding that, during the April survey, Livingston was not in substantial compliance with section 483.25(c) in its care of Resident 90.

(iv) Resident 1

The Statement of Deficiencies states that Livingston had violated the participation requirement in 42 C.F.R. § 483.25(c) by failing to give necessary and proper treatment to promote the healing or prevent the development of a pressure sore on Resident 1's right foot. CMS Ex. 1, at 19. In her declaration, Surveyor Martin recounted her observations concerning that pressure sore. CMS Ex. 14, at 4. Surveyor Martin also reported that she observed Resident 1 sitting in a wheelchair without a pressure-reducing cushion:

I reviewed the assessments . . . and Care Plans completed by Livingston for [Resident 1], and, as noted in the Resident Review Worksheets and Surveyor Notes Worksheets I completed for [Resident 1], the facility had identified him as a moderate risk for pressure sores. Because of this, his care plan identified the need to provide him with a pressure reduction mattress and chair cushion. However, as indicated in my notes, I observed [Resident 1] in his wheelchair without a pressure reduction cushion three times on April 16. I again saw him in his wheelchair without a pressure reduction cushion on April 17, 2001.

Id.

The ALJ concluded that Livingston had created a genuine factual dispute concerning its treatment of Resident 1's right foot. ALJ Decision at 20. Nevertheless, the ALJ concluded that summary judgment was proper with respect to Resident 1 because Livingston had failed to rebut CMS's evidence that he was seen in his wheelchair without a pressure-reducing cushion, an item required by his plan of care. Id.

Relying on the Walden declaration, Livingston now contends that pressure-reducing surfaces were indeed "made available" to Resident 1. RR at 21. However, the supporting documents cited by Kinda Walden (CMS Ex. 7, at 63-64), even if viewed in the light most favorable to Livingston, do not rebut Surveyor Martin's sworn statement that Resident 1 was seen sitting in a wheelchair on April 16 or 17 without a pressure-reducing cushion. In addition, Livingston does not allege or establish that its failure to provide the cushion caused a potential for only minimal harm.

Livingston also repeats a contention, first made to the ALJ, that it "was without notice" of the allegation regarding its failure to provide Resident 1 with pressure relief until it received CMS's summary judgment motion. RR at 20. Livingston asserts that ODH's failure to notify it of this allegation in the Statement of Deficiencies constitutes a denial of due process. Id.

We find no merit to this contention. Due process requires adequate notice of the issues in controversy and a meaningful opportunity to be heard. Illinois Department of Children and Family Services, DAB No. 1037 (1989). There was adequate notice in this case because CMS's summary judgment motion clearly advised Livingston of the evidence and allegation supporting its prima facie case regarding Resident 1. In addition, Livingston had an opportunity to respond to the summary judgment motion and to proffer rebuttal evidence. Livingston does not explain why this opportunity was not meaningful or adequate under the circumstances.

Even assuming that Livingston received inadequate notice of CMS's allegations, there was no violation of due process because there has been no showing of prejudice stemming from the allegedly deficient notice. See St. Anthony Hospital v. U.S. Dep't of Health and Human Services, 309 F.3d 680, 708 (10th Cir. 2000); Vitas Healthcare Corp. of California, DAB No. 1782 (2001).

Livingston has not shown that the alleged lack of notice impaired its ability to defend its interests in these proceedings or delayed its achievement of substantial compliance with Medicare participation requirements.

In short, we conclude that Livingston failed to create a genuine factual dispute about whether it furnished Resident 1 with a pressure-reducing cushion as required by the plan of care. We therefore affirm the ALJ's finding that, during the April survey, Livingston's care of Resident 1 was not in substantial compliance with section 483.25(c).

(v) Resident 20

The Statement of Deficiencies states that, on all four days of the April survey (April 16-20), Resident 20 was seen sitting in a wheelchair without a pressure-reducing cushion. CMS Ex. 1, at 20. In addition, the Statement of Deficiencies indicates that, on April 20, Surveyor Misty Martin and a Livingston nurse noted the presence of a stage II pressure sore on Resident 20's right buttock. CMS Ex. 1, at 20; CMS Ex. 14, at 3. The survey agency concluded that the buttock wound was "an avoidable pressure sore that lacked the care planned interventions of a pressure reduction mattress to the bed and a pressure-reducing cushion to the wheelchair." CMS Ex. 1, at 20.

In her declaration, Surveyor Martin stated that she reviewed Livingston's records concerning Resident 20, including his plan of care. CMS Ex. 14, at 4 ¶ 8. She stated that Resident 20 was at "high risk" for pressure sores, and that his plan of care required the provision of a pressure-reducing mattress and chair cushion. Id. Regarding Resident 20's pressure sore, she stated:

[T]he attached Pressure Areas/Skin Problems dated "4-19-01" [CMS Ex. 14, at 13], a copy of a Livingston treatment record I obtained from the facility, refers to the pressure sore as a "Stage I or Tear?" However, I personally observed the sore with R.N. Karen Paxton, Livingston's treatment nurse, on April 20, 2001 and it was a stage II. That staging was confirmed in Karen Paxton's late entry in the nurse's notes which describe the wound as an "open area." A pressure wound with a break in the skin must be a Stage II or higher; it cannot be a Stage I because with a Stage I pressure sore, the skin is still intact. The "Medimark II" treatment record attached to this declaration also refer[s] to the pressure sore on the buttock as an "open area." Even assuming the pressure sore was a Stage 1 on April 19, 2001, the fact that the "Medimark II" treatment record describes it as an "open area" on April 20, 2001 means that by even Livingston's account, the pressure sore became worse during the survey.

Id. at 3 ¶ 7.

Livingston contended that the wound on Resident 20's right buttock was not a pressure sore. ALJ Decision at 21. The ALJ accepted this assertion as true. However, he determined that the assertion was "insufficient to refute [CMS's] allegations of noncompliance" because "[t]he core allegations of noncompliance are the failure by Petitioner to provide the care called for in its own plan of care for Resident #20." Id. What Livingston undisputably failed to do, the ALJ found, was to give Resident 20 the care it prescribed -- namely, pressure relief -- to prevent pressure sores. Id.

We agree with the ALJ that Livingston did not genuinely dispute the allegation that it failed to provide Resident 20 with prescribed pressure relief. In its request for review, Livingston suggests that its failure to do so was not a violation of section 483.25(c) because no actual injury resulted. RR at 22. We rejected the same argument in our discussion of Resident 90. As we indicated, CMS need not show that the violation caused actual harm.

Livingston also suggests that Resident 20 did not in fact require pressure relief. In particular, it asserts that the nursing staff was taking other measures (skin checks, monitoring of bowel patterns, position changes) to prevent pressure sores. RR at 22; see also Walden Decl. at 4. Livingston also asserts that Resident 20 was not at "high risk" for pressure sores, and "did not have an order for a pressure-reducing pad for the chair or a mattress to the bed." See Walden Decl. at 4.

In our view, these assertions are not sufficient to create a genuine issue of material fact. That Livingston took other precautions to prevent pressure sores does not change the fact that it failed to furnish Resident 20 with an item required by the plan of care. Livingston did show that Resident 20 was not considered to be a "high risk" for pressure sores. His pressure sore risk assessment (PSRA) score was five. A PSRA score of eight or higher denotes a resident at "high risk." See Walden Decl. at 4 & Ex. 3. Nevertheless, a PSRA score of five suggests that Resident 20 was at some risk for pressure sores, and Livingston's own skin care protocol indicates that "moderate risk" residents should be furnished with pressure-reducing surfaces. CMS Ex. 6, at 99. Livingston, however, leaves us to speculate about the magnitude of the risk (whether it was "moderate," low, or negligible) and the implications for treatment. Given that Resident 20's own plan of care instructed the facility to provide pressure relief, such speculation about his susceptibility or risk is insufficient to create a genuine factual dispute.

Regarding the alleged absence of an "order," we are unsure about what Livingston is asserting. If its contention is that the plan of care did not require pressure-reducing surfaces, Livingston has not produced a copy of the plan. Nor has it given us any reason to doubt Surveyor Martin's sworn statement that she reviewed Resident 20's plan of care and found it to require the provision of a pressure-reducing mattress and chair cushion.

For the reasons above, we affirm the ALJ's conclusion that during the April survey, Livingston's care of Resident 20 was not in substantial compliance with section 483.25(c).

Issue 3: Whether the ALJ erred in finding that Livingston did not attain substantial compliance until May 11, 2001.

Livingston asks us to vacate the ALJ's finding that its noncompliance continued from April 20 until May 11, 2001. RR at 23. However, this request is premised on its contention, which we have rejected, that CMS was not entitled to summary judgment with respect to the deficiencies involving Residents 83, 73, 90, 1, and 20. As explained above, CMS produced undisputed evidence that Livingston was not in substantial compliance with 42 C.F.R. § 483.25(c) during the April survey and was therefore entitled to summary judgment. In addition, there is no evidence that Livingston cured this noncompliance prior to the May 11, 2001 revisit survey. For these reasons, we affirm the ALJ's finding that Livingston did not attain substantial compliance with Medicare participation requirements until May 11, 2001.

Issue 4: Whether substantial evidence supports the ALJ's finding that the amount of the CMP was reasonable.

The ALJ found that the $500 per day CMP imposed by CMS was reasonable. For reasons described below, Livingston asserts that this finding is "legally erroneous" and "lack[s] factual foundation." RR at 23.

In Careplex of Silver Spring, DAB No. 1683 (1999), we held that an ALJ's assessment of a CMP's reasonableness must be guided in part by the factors specified in 42 C.F.R. § 488.438(f). These factors are the facility's history of noncompliance, its financial condition, and its culpability for the cited deficiencies. Section 488.438(f) cross-references 42 C.F.R. § 488.404, which states that CMS considers the "seriousness" -- that is, the "scope" and "severity" -- of a facility's noncompliance in selecting a remedy. (8) However, we held in Careplex that an ALJ must accept CMS's assessment of the seriousness of the facility's noncompliance (except in limited circumstances not present here). Notwithstanding this restriction, the ALJ's evaluation of the CMP must be an independent determination about "whether the evidence presented on the record concerning the relevant regulatory factors supports a finding that the amount of the CMP is at a level reasonably related to an effort to produce corrective action by a provider with the kind of deficiencies found and in light of the other factors involved (financial condition, facility history, and culpability)." Careplex of Silver Spring.

In concluding that the $500 per day CMP was reasonable, the ALJ noted that ODH had rated the seriousness of Livingston's noncompliance at level H, which refers to a pattern of noncompliance that causes actual harm. ALJ Decision at 23; see also CMS Ex. 1 at 13; SOM § 7400(E). The ALJ also found that CMS had proffered undisputed evidence of a "pattern" of noncompliance resulting in harm to Livingston's residents. In addition, the ALJ stated:

I find that civil money penalties of $500 per day -- only 1/6 of the maximum penalty amount that may be imposed for non-immediate jeopardy deficiencies -- are quite reasonable given the egregiousness of Petitioner's noncompliance. The picture that emerges from the undisputed facts of this case is of a facility whose staff was woefully lacking in attentiveness to residents' needs and prescribed care. Petitioner failed on multiple occasions to provide care that its own staff had determined to be necessary to prevent the development of, or to treat, pressure sores.

ALJ Decision at 24-25 (emphasis added). Finally, the ALJ observed that neither party had offered evidence concerning Livingston's history of noncompliance, financial condition, or degree of culpability. Id. at 24.

Livingston contends that the ALJ erred by not considering all of the pertinent regulatory factors. RR at 23. However, the ALJ was obligated to consider only those factors for which the parties submitted evidence. Cf. Emerald Oaks, DAB No. 1800 (2001) (finding that CMS need not offer evidence concerning the regulatory factors as part of its prima facie case). Livingston does not assert that it submitted evidence on any particular factor. Nor does it contend that the ALJ failed to consider any factor for which there was evidence, or that any unconsidered factors warrant a smaller CMP. Livingston simply asserts what we and the ALJ have found not to be true -- namely, that it "presented evidence of compliance with the participation requirement for each resident at issue." RR at 24.

Livingston also contends that the ALJ erred in finding that the deficiencies caused "actual harm." RR at 24. Actual harm is, in fact, the survey agency's characterization of the "severity" of Livingston's noncompliance, a characterization which, we have held, the ALJ was bound to accept in assessing the reasonableness of the CMP. See Careplex of Silver Spring. Moreover, the record contains substantial and undisputed evidence that Livingston's noncompliance resulted in actual harm to at least one resident. As indicated, Resident 83 had a red area on her foot that was left untreated for 13 days and ultimately became a stage II pressure sore. In addition, Resident 83 was found to have a pressure sore on her left buttock, a likely consequence of Livingston's documented failure to provide her with a pressure-reducing mattress or seat cushion.

Even if we determined that the cited deficiencies had caused no actual harm, we would still find that the ALJ gave reasons sufficient to support his reasonableness finding. As indicated, the ALJ found that the CMP was justified not only by the harm caused, but by the "pattern" of Livingston's noncompliance, by its "repeated failure" to provide necessary or prescribed care. Livingston does not dispute that the deficiencies constituted a "pattern" of noncompliance. Nor does it challenge the ALJ's characterization of the facility's deficiencies as "inattentiveness," a shortcoming that, in our view, reflects some degree of culpability. See 42 C.F.R. § 488.438(f)(4) (defining "culpability" as "neglect, indifference, or disregard for resident care, comfort, or safety").

In short, the ALJ assessed the reasonableness of the penalty by considering the seriousness of the deficiencies and the mitigating evidence (of which there was none) relating to the pertinent regulatory factors. This assessment was consistent with our holding in Careplex. Accordingly, we affirm the ALJ's finding that the amount of the CMP was reasonable.

Issue 5: Whether the ALJ erred in finding that Livingston could not contest CMS's finding that it provided a substandard quality of care.

The ALJ ruled that Livingston had no right to contest CMS's finding that it provided a "substandard quality of care" because it did not challenge the two-year prohibition on nurse aide training. ALJ Decision at 25. Livingston discusses this ruling in its request for review (at page 24), but we detect no argument or contention that the ruling was erroneous or otherwise prejudiced Livingston. Consequently, we do not disturb it.

Conclusion

For the reasons above, we affirm the ALJ Decision in its entirety and sustain the CMP (totaling $10,500) imposed in this case. In doing so, we affirm and adopt all of the FFCLs made by the ALJ.

JUDGE
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Judith A. Ballard

Marc R. Hillson

Donald F. Garrett
Presiding Board Member

FOOTNOTES
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1. The regulations define "substandard quality of care" to mean "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.

2. Unlike the ALJ in this case, the ALJ in Glenburn Home found that material facts were in dispute, a finding that we upheld on appeal. The issue in that case was not whether use of the summary judgment procedure deprived the provider of its hearing rights, but whether the provider had waived those rights under 42 C.F.R. § 498.66.

3. Even if we concluded that genuine issues of material fact existed as to as many as four residents (which we do not), summary judgment in CMS's favor would still be proper because CMS proffered undisputed evidence that Livingston was not in substantial compliance regarding the remaining resident(s).

4. As Livingston concedes (RR at 15), a pressure sore can be considered unavoidable only if routine preventive care is provided. See SOM Appendix PP (Guidance to Surveyors); CMS Ex. 11 at 2. Ms. Walden did not identify any routine preventive steps taken with regard to Resident 83's left leg. She did state that Livingston could not "pad" the metal bars on the immobilizer because "this would have placed more pressure on the leg, defeating the purpose of the use of the immobilzer." Walden Decl. at 6. However, the basis for this statement is unclear. There are no records showing that this treatment dilemma was discussed by the medical staff prior to the survey. In addition, Ms. Walden does not indicate that she was personally involved in providing Resident 83's care, or that she discussed the problem with persons responsible for that care. Under the circumstances, we are not persuaded that the evidence, even if viewed in the light most favorable to Livingston, establishes that the leg sore was clinically unavoidable.

5. The only support we could find for Ms. Walden's characterization of Resident 73 is an April 4 progress note indicating that she refused to have a bath or get out of bed. CMS Ex. 7, at 53.

6. Livingston's "Pressure Areas/Skin Problems" document (CMS Ex. 13, at 10) indicates that Resident 90 had an open "blister" whose severity was "stage II." Surveyor Gilmore asserted that the right heel wound was a pressure sore "by definition" because the skin was broken, red, and bleeding. CMS Ex. 13, at 3-4. Kinda Walden asserted that what Surveyor Gilmore observed was not a pressure sore but burst skin resulting from lower extremity edema. Walden Decl. at 7.

7. For deficiencies that constitute immediate jeopardy, a CMP in the range of $3,050 - $10,000 per day of noncompliance may be imposed. 42 C.F.R. § 488.438(a)(1)(i). For deficiencies that do not constitute immediate jeopardy, but either cause actual harm or have the potential for more than minimal harm, a CMP in the range of $50 - $3,000 per day may be imposed. 42 C.F.R. § 488.438(a)(1)(ii).

8. "Scope" refers to whether the deficiencies are isolated, widespread, or constitute a pattern. 42 C.F.R. § 488.404(b). "Severity" refers to the degree of harm or effect on residents (did the noncompliance result in actual harm? only minimal harm? a potential for more than minimal harm?). Id.

CASE | DECISION | ANALYSIS | JUDGE | FOOTNOTES