SUBJECT:

Crestview Parke Care Center,

Petitioner,

Centers for Medicare & Medicaid Services.

DECISION

This matter is before me on remand from the Sixth Circuit Court of Appeals. Crestview Parke Care Center v. Thompson, 373 F.3d 743 (6^th Cir. 2004).

Petitioner, Crestview Parke Care Center (Petitioner or Facility), is a long term care facility certified to participate in the Medicare and Medicaid programs as a provider of services. Petitioner challenged the Centers for Medicare & Medicaid Services' (CMS's) determination that, from August 13 until October 21, 1999, it was not in substantial compliance with program participation requirements. The Court of Appeals affirmed that the facility was not in substantial compliance with program participation requirements for the period in question, and has remanded the case for me to determine whether the penalty CMS imposed, $400 per day, is reasonable. For the reasons set forth below, I conclude that the penalty is reasonable.

I. Background

The Court of Appeals summarized the procedural history of this case: Petitioner is surveyed periodically to assure its compliance with Medicare and Medicaid regulations. On August 12, 1999, the Ohio Department of Health (State Agency) completed a Life Safety Code Survey (LSC), and concluded that the facility violated a federal regulation requiring emergency lighting. See 42 C.F.R. �� 483.70(b)(1) and 483.70(a) (incorporating by reference the Life Safety Code of the National Fire Protection Association). 373 F.3d at 744.

The following day, the surveyors returned and found the following additional infractions:

�Citing fifteen specific findings (including dirt, grime, missing and broken tiles), they determined that the facility had failed to provide housekeeping and maintenance services "necessary to maintain a sanitary, orderly, and comfortable interior," as required by 42 C.F.R. � 483.15(h)(2).

�Some residents were not provided care and services necessary "to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with their comprehensive assessments and plans of care," which is required by 42 C.F.R. � 483.25. Specifically, two residents (R44 and R90) were observed lying on their beds without the elbow and heel protectors that they required to ward off pressure sores.

�The facility did not ensure that 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." This would violate 42 C.F.R. � 483.25(c)(1). One resident (R68) had two pressure sores and was not provided pressure-relieving devices. Surveyors observed another resident (R93) wearing pillowed heel protectors that were contaminated with dried serosanginous (containing both serum and blood) drainage.

�Citing seventeen separate food-related deficiencies, including dirty equipment, dried food spills, and potentially botulinus food containers, the surveyors determined that the facility did not "[s]tore, prepare, distribute, and serve food under sanitary conditions," in violation of 42 C.F.R. � 483.35(h)(2).

�For fourteen of its twenty-nine nurse aides, the facility had not provided annual in-service training "sufficient to ensure the continuing competence of nurse aides," as required by 42 C.F.R. � 483.75(e)(8)(i).

Id. at 744-745.

By letter dated August 30, 1999, the State Agency informed Petitioner that it was not in compliance with federal requirements, and, unless its problems were corrected by October 2, 1999, the State Agency recommended that CMS impose a civil money penalty (CMP) of $400 per day, along with other sanctions. In an October 5, 1999 follow-up, the state surveyors not only determined that the facility had not corrected the earlier cited deficiencies, but found twelve additional housekeeping violations. CMS therefore imposed the $400 per-day penalty. See Social Security Act (Act), section 1819(h)(2)(B)(ii) (giving the Secretary the authority to impose penalties not to exceed $10,000 per day). A second follow-up survey on October 21, 1999, demonstrated that the facility had achieved substantial compliance, and, by letter dated November 19, 1999, CMS advised Petitioner that it owed $27,600 for sixty-nine days of noncompliance. 373 F.3d at 745.

The facility timely appealed. After protracted settlement efforts failed, I scheduled the matter for hearing. During a September 10, 2001 prehearing telephone conference, I admitted into the record CMS Exhibits (Exs.) 1 through 48, and Petitioner's Exhibits (P. Exs.) 1 through 6. At that time, I "attempted to delve deeper into the exact nature of" Petitioner's claims, but Petitioner's counsel was "unable to answer many of [my] questions regarding the contours of its appeal." I therefore set a second prehearing conference, instructing the parties to confer, enter into stipulations, and to be prepared to answer my questions as to the matters in dispute. Id.

The tragedy of September 11, 2001, forced postponement of both the prehearing conference and the hearing itself. Instead, I convened a prehearing conference on September 19, 2001. I then learned that, notwithstanding my instructions, the parties had failed to stipulate to any factual matters, or otherwise narrow the issues for hearing. ⁽¹⁾ Id. 42 C.F.R. � 498.47(a). I therefore ordered the parties to submit prehearing briefs containing the facts they intended to prove, and their legal arguments, along with witness affidavits or declarations. After reviewing their submissions, I determined that the matter could be decided on the written record, as the parties had not established material facts in dispute. I subsequently granted CMS's motion for summary judgment, finding that the facility was not in substantial compliance with program requirements and that the penalty imposed was reasonable. Crestview Parke Care Center, DAB CR867 (2002). The Departmental Appeals Board subsequently affirmed my decision. Crestview Parke Care Center, DAB No. 1836 (2002).

Petitioner appealed to the Court of Appeals for the Sixth Circuit. See Act, section 1128A(e).

The Court of Appeals Decision

In a decision dated June 28, 2004, the Court of Appeals agreed, in principle, that administrative matters, such as this, might appropriately be decided by summary judgment so long as they present no dispute of material fact. The Court also affirmed the agency decision in the following respects:

�Petitioner failed to provide adequate emergency power and thus was not in substantial compliance with 42 C.F.R. � 483.70(b)(1).

�Petitioner had 26 housekeeping violations, and was not in substantial compliance with 42 C.F.R. � 483.15(h)(2).

�Petitioner had ten food service deficiencies, and was not in substantial compliance with 42 C.F.R. � 483.35(h)(2).

�Petitioner failed to provide in-service training to certain of its nurse aides, and was not in substantial compliance with 42 C.F.R. � 483.75(e)(8)(i).

�Petitioner was not in compliance with 42 C.F.R. � 483.25, when its staff applied dirty heel protectors over an open pressure sore on R93's foot. With respect to this deficiency, the Court also "emphatically" rejected Petitioner's argument that R44 and R90 did not require heel and/or elbow protectors, citing the physician orders for them.

Id. at 751-753, 755.

The Court thus affirmed the agency finding that the facility was not in substantial compliance with program requirements. However, the Court found two "genuine issues of material fact that may have impacted the determination of whether the penalty was reasonable" (Id. at 751):

�With respect to R44 and R90, did the residents themselves move, shift, or displace the ordered protectors; and

�Were R68's pressure sores clinically unavoidable, and did the facility otherwise succeed in preventing and treating pressure sores?

Id. at 753-754. The Court directed me to determine, on remand, "whether the resolution of the disputed deficiencies in juxtaposition with the deficiencies for which Crestview is undeniably responsible justify the enforcement of the penalty." Id. at 756.

Proceedings on Remand

I scheduled a hearing in this matter for May 25, 2005, and held a telephone prehearing conference on May 9, 2005. Responding to my query, Petitioner indicated its plan to call two witnesses, the facility administrator Julie Hrybiniak, and Tom Schindler, an employee in the facility's corporate office, Strategic Nursing Systems, Inc. CMS objected to Petitioner's calling Tom Schindler, noting that Mr. Schindler was not included on Petitioner's witness list, and Petitioner had not submitted his declaration, as required by my September 19, 2001 order. Indeed, Petitioner had neither asked leave to amend its witness list nor proffered a declaration from Mr. Schindler. I nevertheless afforded Petitioner the opportunity to ask leave to amend, and the parties briefed the issue.

In a ruling dated May 17, 2005, I denied Petitioner's motion to add Mr. Schindler to its witness list, ruling: 1) Petitioner failed to demonstrate "extraordinary circumstances (such as surprise or rebuttal)" and lack of substantial prejudice to the objecting party, as required by Civil Remedies Procedures, CRD Procedures � 4; 2) Petitioner unduly delayed its request to amend; 3) Petitioner did not show that the new witness was necessary to respond to new or unexpected evidence, as required by an earlier order in this case; 4) Petitioner's motion effectively duplicated a motion I denied in an October 3, 2001 ruling, and Petitioner offered no reason why I should overturn that ruling. Order Denying Motion to Amend Witness List (May 17, 2005); see Crestview, 373 F.3d at 756 (ALJ properly refused to admit declaration that was tendered after the closing of the record).

I convened the in-person hearing in Cincinnati, Ohio, on May 25, 2005. Petitioner's counsel announced that his sole witness, Julie Hrybiniak, "was admitted to St. Luke's Hospital emergency room and is not available this morning for testimony." Transcript (Tr.) at 9. Petitioner did not ask for a continuance, and CMS waived its right to cross-examine Ms. Hrybiniak, allowing me to consider the testimony presented in her declaration. Tr. at 12. Petitioner's counsel then waived its right to cross-examine CMS's two witnesses, stating: "We'll do it on the brief . . . and in the record that's already present." Tr. at 13. I subsequently denied CMS's request to present rebuttal testimony. Tr. at 16.

Following these proceedings, the parties filed their post-hearing briefs, and CMS replied to Petitioner's brief. Though afforded the opportunity, Petitioner did not reply to CMS's post-hearing brief.

II. Issue

On remand, the sole issue before me is whether the amount of the CMP imposed, $400 per day from August 13 until October 21, 1999 (total of $27,600), is reasonable. ⁽²⁾

III. Discussion

A. Petitioner has waived its procedural challenges . ⁽³⁾

At the in-person hearing, Petitioner did not produce any of its listed witnesses, and did not seek a postponement of the hearing in order to assure the attendance of the sole witness it intended to call. ⁽⁴⁾ Petitioner then affirmatively and unambiguously waived its right to cross-examine CMS's witnesses, who were present and available, and Petitioner objected to CMS's calling those witnesses in order to present rebuttal testimony. Nevertheless, without any reference to the transcript, Petitioner now complains that no evidence was taken during the in-person hearing, and faults the judge for not eliciting whatever testimony counsel himself failed to present. Petitioner does not identify that additional testimony or evidence.

To support these claims, Petitioner simply misrepresents what transpired during the May 25, 2005 proceedings. First, Petitioner complains that "the ALJ refused to allow Crestview to secure a continuance as its witness suffered a medical emergency immediately prior to the hearing and was medically unable to attend . . . ." P. Post-hearing brief at 2. In fact, Petitioner did not request a continuance. That Petitioner did not request a continuance was not surprising, since Ms. Hrybiniak's failure to appear disadvantages CMS rather than Petitioner. Her testimony is already in the record in the form of her declaration, and Petitioner's counsel did not show that her live testimony would elicit any additional facts in support of its position. CMS, on the other hand, would presumably have been prejudiced by her failure to appear because it lost the right to cross-examine her. However, CMS waived that right ("[W]e would waive our right to cross-examination if this hearing will be the final hearing as far as testimony goes"), so I am able to consider Ms. Hrybiniak's declaration, notwithstanding Petitioner's inability to produce her for cross-examination. Tr. at 12.

Next, Petitioner complains that it was not allowed to cross-examine CMS's witnesses. P. Post-hearing Brief at 10 ("The ALJ would not allow Crestview to conduct cross-examination at the May 25, 2005 proceedings"). As the transcript shows, CMS's witnesses were present and available for cross-examination. But, when CMS waived its right to cross-examine Ms. Hrybiniak, Petitioner responded by explicitly waiving its right to cross:

MR. WEBSTER: Well, then, Your Honor, if I waive our right to cross-examine - and I'm not doing that necessarily yet - but waive my right to cross-examine CMS' witnesses, are we done?

JUDGE HUGHES: Yes.

MR. WEBSTER: I'll waive that right. We'll do it on the brief, Your Honor, and in the record that's already present.\

Tr. at 13.

Finally, citing the Social Security disability case of Cox v. Apfel, 160 F.3d 1203 (8^th Cir. 1998), Petitioner argues that the Court of Appeals decision here and basic principles of administrative law require the judge to "proactively elicit testimony to resolve the material issues of fact." P. Post-hearing brief at 10. I recognize that judges have a heightened obligation to develop the record in the non-adversarial Social Security disability proceedings. In those types of cases, however, the judge's obligation derives from the statute and regulations. See Act, section 423(d)(5)(B) (Compelling the Commissioner of Social Security "to make every reasonable effort" to obtain medical evidence); 20 C.F.R. � 404.1512(d) ("Before we make a determination that you are not disabled, we will develop your complete medical history . . . We will make every reasonable effort to get your medical reports . . . ."). I am not aware of any similar authority - and Petitioner cites to no authority - that would apply this same judicial obligation to a manifestly adversarial proceeding, such as this. Moreover, even in disability cases, the judge "is under no duty to go to inordinate lengths to develop a claimant's case." Battles v. Shalala, 36 F.3d 43, 44 (8^th Cir. 1994). And Petitioner has not described what additional evidence the judge should have elicited here.

B. A $400 per day CMP is reasonable based solely on the deficiencies for which the Court of Appeals found the facility "undeniably responsible."

If a facility is not in substantial compliance with program requirements, CMS may impose a CMP for each day of substantial noncompliance. Act, section 1819(h); 42 C.F.R. �� 488.402; 488.408. Where the deficiencies do not pose immediate jeopardy to resident health or safety, but have either caused actual harm or have the potential for more than minimal harm, the penalty will be in the range of $50 to $3,000 per day. 42 C.F.R. �� 488.408(d); 488.438(a). At $400 per day, the penalty here is at the lower end of the mandatory range.

I determine whether the amount of a CMP is reasonable by applying the factors listed in 42 C.F.R. � 488.438(f): 1) the facility's history of noncompliance; 2) the facility's financial condition; 3) factors specified in 42 C.F.R. � 488.404; and 4) the facility's degree of culpability, which includes neglect, indifference, or disregard for resident care, comfort, or safety. The absence of culpability is not a mitigating factor. The factors in section 488.404 include: 1) the scope and severity of the deficiency; 2) the relationship of the deficiency to other deficiencies resulting in noncompliance; and 3) the facility's prior history of noncompliance in general and specifically with reference to the cited deficiencies. In applying these factors, I do not consider CMS's internal decision-making processes. Instead, I consider whether the evidence presented on the record concerning the relevant regulatory factors supports finding that the penalty amount 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, culpability). I am neither bound to defer to CMS's factual assertions, nor free to make a wholly independent choice of remedies without regard for CMS's discretion. Community Nursing Home, DAB No. 1807, at 22 et seq. (2002); Care Plex of Silver Spring, DAB No. 1638, at 8 (1999).

On remand, Petitioner has presented no challenge to the amount of the CMP (aside from its general claim of substantial compliance). Earlier, Petitioner cited just one factor in its argument that the penalty amount is unreasonable: it claimed that it could not afford to pay the penalty. However, the Court of Appeals affirmed that evidence of the facility's financial condition is not appropriately before me because Petitioner neither timely raised the issue, nor timely presented its evidence relevant to the issue. 373 F.3d at 756.

With respect to the remaining section 488.438(f) factors, the Court of Appeals invited Petitioner, upon remand, to rebut the presumption that past noncompliance accurately predicts future problems. 373 F.3d at 757. But Petitioner has not done so, and the record shows a facility history of deficiencies in the areas cited here: failure to provide services to prevent the formation of pressure sores, and to promote the healing of pressure sores; housekeeping and maintenance; dietary services; and administration. During the prior survey cycle (1998), CMS found deficiencies involving prevention and treatment of pressure sores that resulted in actual harm. CMS Ex. 13; Weidler Declaration at 4, � 8. Housekeeping and maintenance services were cited as deficient during the prior year, as were dietary services and administration. Id. Moreover, even after the change of ownership, housekeeping and maintenance services were not immediately corrected. The October 5, 1999 follow-up survey disclosed twelve additional housekeeping violations.

Even if I did not consider the facility's history, other factors justify this relatively small penalty. In remanding this matter, the Court recognized that resolution of the remaining facts in dispute would not necessarily alter the result, concluding that there were "genuine issues of material fact that may have impacted the determination of whether the penalty was reasonable." 373 F.3d at 751 (emphasis added) . I find that the deficiencies for which the facility is undeniably responsible, by themselves, justify the penalty.

The facility was unquestionably out of compliance in five major areas. Failing to provide adequate emergency power (K046), along with the food service deficiencies (F371), had potential for more than minimal harm and widespread scope (level F), potentially jeopardizing the safety of every resident in the facility. The facility's failure to train its nurse aides as required (F497) and its housekeeping deficiencies evidenced patterns of additional noncompliance, affecting resident comfort and safety. I consider the facility particularly culpable for its housekeeping and maintenance deficiencies. I also consider its application of dirty heel protectors over an open pressure sore a blatant disregard for R93's health and safety. In light of all these deficiencies, I am not able to find unreasonable CMS's determination to impose a CMP at the lower end of the mandatory range.

C. The facility failed to provide necessary care and services to ensure that each resident maintained the highest practicable physical, mental, and psychosocial well-being, in accordance with his/her comprehensive assessment and plan of care. 42 C.F.R. � 483.25.

Under the statute and "quality of care" regulation, each resident must receive and the facility must provide the necessary care and services to attain or maintain the highest practicable physical, mental, and psychological well-being, in accordance with the resident's comprehensive assessment and plan of care. Act, section 1819(b); 42 C.F.R. � 483.25. Accordingly, the facility must conduct an initial and periodic resident assessment of functional capacity. The assessment must be comprehensive, accurate, standardized, and reproducible. Based on the comprehensive assessment, the facility must ensure that a resident who enters the facility without pressure sores does not develop them unless the individual's clinical condition shows that they were unavoidable, and a resident having pressure sores receives treatment and services necessary to promote healing, prevent infection, and prevent new sores from developing. 42 C.F.R. � 483.25(c).

CMS concluded that the facility was not in substantial compliance with the quality of care requirements, based on surveyor observations as to the care provided to four residents: R44, R90, R68, and R93.

With respect to R44 and R90, I am charged with determining whether the residents themselves were responsible for removing their heel/elbow protectors. R44 was bedfast; she had severe muscle contractures, including in her arms, and the parties agree that she was at high risk for skin breakdown. Indeed, according to Petitioner, her diagnoses - CVA, hypertension, osteoarthritis, dysphasia, congestive heart failure, and diabetes - made skin breakdown unavoidable. Hrybiniak Declaration at 2-3, � 4a; see also McClure Declaration at 3-4, � 18. ⁽⁵⁾ R44's physician therefore ordered "heel protectors on at all times (w/ankle rings)[and] bilat[eral] elbow protectors on at all times." P. Ex. 1, at 1. R44's care plan, responding to her risk for skin break-down, called for "heel protectors and elbow protectors as ordered." P. Ex. 1, at 8. The Court of Appeals "emphatically" rejected Petitioner's suggestion, which Petitioner repeats on remand (P. Post-hearing Brief at 3), that R44 did not require heel and elbow protectors. Crestview, 373 F.3d at 753.

Similarly, R90 had a history of skin breakdown, and also had orders in place for bilateral heel protectors "at all times," bilateral elbow protectors "at all times for preventive measure," and for a cone splint for his hand to be worn from 7 A.M. to 7 P.M., then taken off at bedtime. R90 had paralysis on his right side as the result of a stroke, and his right hand was severely contractured. The cone splint was designed to hold his hand partially open to avoid worsening the contractures. P. Ex. 2, at 2, 4, 6, 9; Cobb Declaration at 3, � 8. R90's care plan acknowledged these problems, and, among other measures, called for "heel protectors as ordered," "elbow protectors as ordered," and "cone splint as ordered." P. Ex. 2, at 16-17. Again, the Court of Appeals rejected Petitioner's suggestion that R90 did not require these protective devices. Crestview, 373 F.3d at 753.

Yet on three days of the survey, the surveyors observed R44 without elbow protectors. Specifically, at 2:00 P.M. on August 10, 1999, she was lying on her elbow on her right side without protectors. Throughout the day on August 11, 1999, she was observed without the protectors. On August 12 at 8:15 A.M. she had no protectors; and at 8:55 A.M. she was observed lying on her elbow on her left side without the elbow protectors. CMS Ex. 3, at 5-6; CMS Ex. 23, at 4; McClure Declaration at 4, � 18.

The surveyors observed R90 on August 12 at 8:30 A.M. (awake and in bed), 9:15 A.M. (sleeping), and 11:30 A.M. (up in a chair with his arms on the arm rest) without elbow protectors. They observed him in a geri chair in the dining room at 1:50 P.M. without elbow protectors, heel protectors, or hand splint. CMS Ex. 3, at 6; CMS Ex. 22, at 4.

The Court of Appeals affirmed the surveyor observations. Crestview, 373 F.3d at 754. With respect to Petitioner's defense - that the residents themselves removed or shifted the protectors or that staff members removed the protectors to provide other treatment - the Court recognized:

Crestview's evidence in this vein is not strong, chiefly because Crestview has failed to point to any patient records or preserved staff observations of such behavior . . . Upon remand, the ALJ may conclude in fact that Crestview has not proven it acted reasonably in failing to adhere to these residents' plans of care.

Id.

Petitioner's evidence on remand is exactly the same as that presented earlier, and the Court of Appeals is correct. It is not strong.

Administrator Hrybiniak asserts:

The facility nursing staff makes treatment rounds during the 8:00 o'clock and 2:00 o'clock times. The purpose of that is to provide treatment and care and it is a matter of facility routine that the heel/elbow protectors will be removed.

Hrybiniak Declaration at 2, � 4a. She also claims that residents can and do remove, shift, or displace the protectors. They "are anticipated to be routinely moved, dislodged, or out of place." Hrybiniak Declaration at 2-3.

  I have no reason to doubt that nursing staff made their rounds at 8 A.M. and 2 P.M., but that fact does not mean that the surveyors just happened, consistently, to observe these residents during those limited moments that nursing staff had removed protectors in order to provide care. To comply with physician orders and the resident care plans, staff should have reapplied the protectors immediately following treatment. Moreover, the timing of the nursing rounds would not explain the absence of R44's protectors throughout the day on August 11, nor as late as 8:15 and 8:55 A.M. on August 12, nor the absence of R90's protectors at 8:30 A.M., 9:15 A.M., 11:30 A.M., and 1:50 P.M. ⁽⁶⁾ Moreover, R90 was awake and in bed at 8:30, sleeping at 9:15, sitting up in a chair with arms on the arm rest at 11:30. R44 was twice observed lying on an elbow without protectors. Those observations are inconsistent with the suggestion that the residents were being examined and treated at those times. Thus, the record establishes that the protectors were not in place at all times, as ordered by the treating physicians and dictated by the plans of care. 373 F.3d at 754; see Community Nursing Home, DAB No. 1807, at 18 (2002) (Surveyor observations, as recorded in the survey report form, found credible in the absence of any evidence from the Petitioner that refuted the findings).

With regard to Petitioner's minimally supported claim that the residents themselves might have removed the protectors, I note that if, for any reason, the facility is unable to keep the protectors in place, as required by physician order and care plan, that fact should be documented, and then considered by the interdisciplinary team in developing the plan of care. The resident medical records suggest no problems with keeping the protectors in place, much less any consideration of such problem by the interdisciplinary teams. P. Exs. 1, 2. Petitioner points to evidence that R90 "move[d] around, scratch[ed]" and was "verbally abusive." P. Post-hearing brief at 3. This does not establish that he removed his protectors, and does not justify the facility's failure to insure that they were in place.

For each of these individuals, the treating physician determined that the resident required protectors and ordered them. The interdisciplinary team agreed, and incorporated the physician orders into the resident's plan of care. The regulations require that the facility provide care "in accordance with the comprehensive assessment and plan of care." 42 C.F.R. � 483.25. That Petitioner failed to do so violates the regulation, and creates a risk for more than minimal harm to individuals who were at high risk for developing pressure sores.

D. The facility failed to ensure that its residents not develop avoidable pressure sores, and did not ensure that a resident having pressure sores received the treatment and services necessary to promote healing, prevent infection, and prevent new sores from developing. 42 C.F.R. � 483.25(c)(2).

In assessing the facility's compliance with 42 C.F.R. � 483.25(c)(2), the relevant question is: did the facility "take all necessary precautions" to promote healing, prevent infection, and to prevent new sores from developing. If so, and the resident develops sores anyway, I could find no deficiency. But, if the evidence establishes that the facility fell short of taking all necessary precautions and the resident develops pressure sores, then the regulation is violated. Koester, DAB No. 1750, at 32. The Court of Appeals has already affirmed that the facility was not in compliance with 42 C.F.R. � 483.25(c)(2) because staff applied a dirty heel protector over R93's open pressure sore. 373 F.3d at 755. Applying a soiled heel protector on to an open pressure sore does not establish that the facility took "all necessary precautions" to prevent infection.

With respect to R68, I am charged with determining whether her pressure sores were clinically unavoidable, and whether the facility succeeded in preventing and treating her pressure sores. R68 was diagnosed with multiple sclerosis, dysphagia (difficulty swallowing), iron deficient anemia, and dermatitis. P. Ex. 3, at 1. She had a gastrostomy tube for feeding, was bed-ridden, and had multiple contractures, such that she was unable to reposition herself. P. Ex. 3, at 12, 43, 84; CMS Ex. 21; Grimes Declaration at 2, � 5. The parties agree that she was at high risk for developing pressure sores, and, in August 1999, she had a stage II open sore on her left buttock, and a stage II open sore on her left hip. ⁽⁷⁾ P. Ex. 3, at 48-73, 81; Grimes Declaration at 2, � 5. According to treatment records, a pressure sore on her left elbow had healed, so the facility stopped treatment for that on July 23, 1999. P. Ex. 3, at 60-61; Grimes Declaration at 2, � 5. R68's physician ordered pressure relieving devices on both feet and both elbows at all times. P. Ex. 3, at 16, 18; Grimes Declaration at 2, � 5. Remarkably, Petitioner suggests that the record contains no order for "pillowed pressure relieving devices on both feet and elbows at all times." P. Post-hearing brief at 5. Although the word "pillowed" does not necessarily appear, the physician order for heel and elbow protectors at all times is repeated throughout this resident's treatment records. It appears that the physician repeatedly reordered them. P. Ex. 3, at 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34.

Notwithstanding the physician orders, at 1:00 P.M. and again at 2:00 P.M. on August 10, 1999, the surveyor observed R68 in bed with pressure relieving devices on her right elbow and both feet, but none on her left elbow, which was resting directly on the mattress. Although Petitioner questions whether the surveyor accurately recorded R68's positions at all of these times, the more pertinent question is whether she had in place all of the ordered heel and elbow protectors. The overwhelming and uncontradicted evidence establishes that she did not.

On August 11, 1999, at 10:30 A.M., 3:00 P.M., and 5:30 P.M., the surveyor, with the nurse, observed the resident's left hip had a 6 cm by 4 cm pressure sore with thick yellow slough. The left buttock area had an 8 cm by 4 cm stage II red and bloody pressure sore. The surveyor observed dried, yellow drainage on the resident's gown directly under her left elbow, and the left elbow had a 2 cm by 3 cm stage II pressure sore with yellow slough. CMS Ex. 3, at 7-8; P. Ex. 3, at 8, 13; Grimes Declaration at 2-3, � 6; see P. Ex. 3, at 10.

Petitioner nevertheless suggests that the facility "took all necessary precautions" because R68 was turned and repositioned regularly and lay on a pressure relieving mattress. P. Post-hearing brief at 4. Again, the Court of Appeals rejected the suggestion that a resident does not require such protectors in the face of a physician's order that she have them. 373 F.3d at 753. In holding that a facility may not defend its failure to follow a physician's order by challenging those orders, the Court said:

If the staff believes that a resident does not need protectors or some other treatment ordered by a physician, the proper course of action is to rework the patient's comprehensive plan of care in a venue other than HHS's administrative appeals process. Barring such revision, the facility must follow the plan of care.

Id.

Petitioner also points to evidence that after a pressure sore developed on R68's left elbow, the facility provided appropriate care, and the sore thereafter healed. Certainly, if the facility had not treated appropriately the pressure sore after it developed, the seriousness of its deficiency would have been compounded. But the facility was supposed to have been equally vigilant in preventing the sore from developing in the first place. I agree with CMS that evidence of proper care curing the sore suggests that the sore was preventable. CMS Post-hearing reply brief at 10.

The evidence establishes that the facility did not follow physician orders in keeping R68's left elbow protected. This fact, along with staff's applying soiled heel protectors directly on to R93's open sores, establishes that the facility failed to take "all necessary precautions" to prevent new pressure sores from developing, and CMS appropriately found the facility out of compliance with 42 C.F.R. � 483.25(c)(2).

E. Petitioner's collateral attack on the Departmental Appeals Board's decisions on burden of proof is irrelevant where, as here, a preponderance of evidence supports CMS's findings .

The Departmental Appeals Board has discussed in detail the allocation of burdens of proof in cases brought under 42 C.F.R. � Part 498 to enforce compliance with participation requirements for long term care facilities. Batavia Nursing and Convalescent Center, DAB No. 1904 (2004), aff'd Batavia Nursing and Convalescent Center v. Thompson, No. 04-3325 (6^th Cir. April 15, 2005); Hillman Rehabilitation Center, DAB No. 1611 (1997), aff'd, Hillman Rehabilitation Center v. United States, No. 98-3789 (GEB) (D.N.J. May 13, 1999); see also Community Skilled Nursing Centre, DAB No. 1987, at 4 (2005). Petitioner argues that those decisions are in error. I need not apply the Hillman standard here because, as is evident from the discussion above, a preponderance of evidence supports the conclusion that the facility was not in substantial compliance, and the CMP imposed is reasonable. Batavia Nursing and Convalescent Center v. Thompson, No. 04-3325 (6^th Cir. April 15, 2005) ("We do not address Batavia's argument on this issue because . . . the evidence is clearly not in equipoise . . . .); Sea Island Comprehensive Healthcare Corporation v. Department of HHS, 79 Fed. Appx. 563, 565-566 (4^th Cir. 2003) (where substantial evidence supported the finding that the facility was out of compliance, Court declined to consider challenge to Hillman rule); accord, Fairfax Nursing Home, Inc. v. Department of HHS, 300 F.3d 835, 840 n.4 (7^th Cir. 2002); see also Windsor Health Center v. Leavitt, No. 04-3018 (6^th Cir. April 13, 2005) (where neither the ALJ nor the Appeals Board directly applied Hillman, the court characterized the facility's collateral attack on the Hillman standard as "spurious.")

IV. Conclusion

For all of the reasons discussed above, I uphold CMS's determination that, from August 13, 1999, until October 21, 1999, the facility was not in substantial compliance with program participation requirements, specifically 42 C.F.R. �483.15 (Environment), 42 C.F.R. � 483.25 (Quality of Care), 42 C.F.R. � 483. 35 (Dietary Services), 42 C.F.R. � 483.75 (Administration), and 42 C.F.R. � 483.70(a) (Life Safety Code). The amount of the CMP imposed, $400 per day, is reasonable.

Carolyn Cozad Hughes

Administrative Law Judge

1. Petitioner had not responded to CMS's proposed stipulations.

2. Petitioner argues that the evidence does not establish its substantial noncompliance. P. Post-hearing Br. at 3, et seq. However, as discussed above, the Court of Appeals has already affirmed the agency finding of substantial noncompliance, so that issue has been resolved.

3. I make Findings of Fact and Conclusions of Law (Findings) to support my decision in this case. I set forth each Finding as a separate heading.

4. Petitioner's witness list, received December 5, 2000, named five proposed witnesses. In addition to Ms. Hrybiniak, the list included the facility's directors of environmental and dietary services, and two nurses, the facility's Director of Nursing, Sara Goodman, and LPN (Licensed Practical Nurse) Rhonda Blackaby. By the time of the remand hearing, the testimony of the environmental and dietary services directors were no longer relevant since the Court of Appeals has resolved the issues they addressed. Petitioner itself determined not to call the facility nurses Goodman and Blackaby, whose departure from the facility was purportedly "not on an amicable basis," and whose cooperation "by way of voluntary appearance" was "not expected." Memorandum in Support of Petitioner's Motion to Amend and Supplement List of Witnesses at 3 (May 11, 2005). Of course, Petitioner could have sought issuance of subpoenas to compel the nurses' attendance. 42 C.F.R. � 498.58(a).

5. Earlier Petitioner denied that R44 had pressure sores, claiming instead that she had unavoidable diabetic foot ulcers. Petitioner seems to have abandoned this argument on remand. And R44's medical records establish that she had pressure sores. In listing the type of ulcer, the facility consistently lists "pressure ulcer" and specifically denies the presence of stasis ulcers (open lesions caused by poor circulation in the lower extremities). P. Ex. 1, at 9, 10, 11, 12, 13.

6. These documented instances, along with the surveyor observations of R68 and R93 (see Discussion, infra), suggest a pattern rather than an isolated incident, but even an isolated incident, if serious enough, may indicate problems in the facility since a survey can only be a sample of facility conditions, especially given that this deficiency would not necessarily have been detectable in a record review. Koester Pavilion, DAB No. 1750, at 37 (2000).

7. A stage II pressure sore is characterized by partial loss of skin thickness in the epidermis and/or dermis skin layers. It presents as an abrasion, blister or shallow crater.