SUBJECT:

St. Catherine's Care Center of Findlay,

Petitioner,

Centers for Medicare & Medicaid Services.

DECISION

Petitioner, St. Catherine's Care Center of Findlay (Petitioner or facility), is a long term care facility certified to participate in the Medicare and Medicaid programs as a provider of services. Following a survey completed June 13, 2002, the Centers for Medicare & Medicaid Services (CMS) determined that, from June 13 through 20, 2002, the facility was not in substantial compliance with a number of program requirements, and imposed a $400 per day civil money penalty (CMP) for those eight days of purported noncompliance ($3,200 total). Petitioner here challenges that determination.

The parties have agreed that this matter may be decided on the written record, without an in-person hearing.

For the reasons set forth below, I find that the facility was not in substantial compliance with program requirements for the period in question, and find the amount of the CMP reasonable.

I. Background

Following Life Safety Code (LSC) and standard surveys completed January 13, 2002, surveyors from the Ohio Department of Health (State Agency) determined that the facility was not in substantial compliance with federal requirements for nursing homes participating in the Medicare and Medicaid programs. Specifically, with respect to the LSC, the surveyors found:

�The facility lacked an adequate "flame spread rating" for interior walls. Holes in the interior walls of a store room and a resident room meant that smoke and flames could quickly spread into the exit corridor (Tag K015).

�Holes in the basement ceiling below the kitchen, nurses station, and main corridor meant that the partition between these levels did not have a fire resistive rating of at least one hour (Tag K020).

�The closing device was detached and not operational on the door to a storage area containing significant amounts of paper and other combustibles. The closing device for a second storage room was detached and not operational, and the door was not fire-rated. A third storage room door was not fire-rated and lacked an automatic closing device. These problems would allow a fire to spread quickly (Tag K029).

�The facility failed to provide battery back-up lighting for an exit directional sign. Although the sign had a battery in it, it was not operational (Tag K046).

CMS Exhibit (Ex.) 6, at 10-16; CMS Ex. 66; Petitioner's Exhibit (P. Ex.) 3, at 11-17.

With respect to the standard survey findings, the State Agency concluded that the facility was not in substantial compliance with three requirements:

�For two residents, facility services had not met professional standards of quality, in violation of 42 C.F.R. � 483.20(k)(3)(i) (Tag F281: resident assessment).

�The facility had not insured that a resident who entered the facility without pressure sores did not develop them (unless his clinical condition demonstrated that they were unavoidable), in violation of 42 C.F.R. � 483.25(c) (Tag F314: quality of care - pressure sores).

�The facility did not timely obtain laboratory tests necessary to meet the needs of its residents, in violation of 42 C.F.R. � 483.75(j) (Tag F502: administration).

CMS Ex. 6, at 1-9; P. Ex. 3, at 2-10.

CMS agreed with the State Agency, and so advised the facility in a letter dated July 15, 2002. CMS Ex. 1. Among other remedies, CMS imposed a CMP of $400 per day, effective June 13, 2002. Thereafter, the State Agency revisited the facility, and, based on the revisit findings, CMS determined that the facility achieved substantial compliance effective June 21, 2002. In a letter dated August 16, 2002, CMS advised the facility that it had achieved substantial compliance, that other remedies were rescinded, but that a $3,200 CMP remained ($400 per day for eight days of noncompliance). CMS Ex. 2.

Petitioner timely requested a hearing.

The parties agreed to have the matter decided on the written record, without an in-person hearing. See 42 C.F.R. � 498.66 (waiver of right to appear and present evidence); P. Waiver Letter (October 24, 2005); CMS Waiver Letter (October 25, 2005); Order (October 26, 2005). CMS filed a closing brief (CMS Br.) and a reply brief (CMS Reply). Petitioner filed a closing brief (P. Br.). Although afforded the opportunity to do so, Petitioner did not file a reply brief.

CMS has submitted 69 exhibits (CMS Exs. 1-69) and Petitioner has submitted 12 exhibits (P. Exs. 1-12). In the absence of any objections, I admit CMS Exs. 1-69, and P. Exs. 1-12. See Order (October 26, 2005).

II. Issues

The case presents the following questions:

1. From June 13 through 20, 2002, was the facility in substantial compliance with requirements for facilities participating in the Medicare and Medicaid programs, specifically 42 C.F.R. � 483.25, 42 C.F.R. � 483.20, 42 C.F.R. � 483.75, and the LSC?

2. If the facility was not in substantial compliance, is the amount of the CMP imposed, $400 per day for eight days, reasonable?

III. Statutory and Regulatory Background

The Social Security Act (Act) sets forth requirements for nursing facility participation in the Medicare and Medicaid programs, and authorizes the Secretary of Health and Human Services (Secretary) to promulgate regulations implementing the statutory provisions. Act, sections 1819 and 1919. The Secretary's regulations governing nursing facility participation in the Medicare program are found at 42 C.F.R. Part 483. Facilities must maintain substantial compliance with program requirements, and, to be in substantial compliance, a facility's deficiencies may pose no greater risk to resident health and safety than "the potential for causing minimal harm." 42 C.F.R. � 488.301.

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 for each resident the highest practicable physical, mental, and psychosoical 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 initial and periodic resident assessments of functional capacity that are comprehensive, accurate, standardized, and reproducible. 42 C.F.R. �� 483.20, 483.25. The facility must also make a comprehensive assessment of a resident's needs promptly after a significant change in the resident's physical or mental condition. 42 C.F.R. � 483.20(b)(2)(ii). Based on the comprehensive assessment, the facility must, among other requirements, 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. 42 C.F.R. � 483.25(c)(1). The facility must ensure that a resident with pressure sores receives the treatment and services necessary to promote healing, prevent infection, and prevent new sores from developing. 42 C.F.R. � 483.25(c)(2).

Services provided or arranged by the facility must meet professional standards of quality. 42 C.F.R. � 483.20(k)(3)(i).

The facility must also be administered in a manner that enables it to use its resources effectively and efficiently to attain or maintain the highest practicable physical, mental, and psychosocial well-being of each resident. 42 C.F.R. � 483.75. Among other requirements, the facility must provide or obtain laboratory services to meet resident needs, and is responsible for the quality and timeliness of those services. 42 C.F.R. � 483.75(j).

The facility must be designed, constructed, equipped, and maintained to protect the health and safety of its residents, personnel, and the public. 42 C.F.R. � 483.70. The LSC of the National Fire Protection Association is a set of fire protection requirements designed to provide a reasonable degree of safety from fire. By statute and regulation, a skilled nursing facility must meet the nursing home provisions of the LSC, unless the Secretary determines that the health and safety of residents or personnel will not be affected, and waives a particular requirement. Act, section 1819(d)(2); 42 C.F.R. � 483.70(a). Among other matters, the LSC requires that interior surfaces, such as walls, partitions, columns, and ceilings have a "flame spread rating" of 75 or less. ⁽¹⁾ LSC 10-1351; 10-2331. Hazardous areas must be enclosed with one-hour rated construction, or must be sprinklered. LSC 10-2351, 6-5111. 10-1371. Vertical openings must be enclosed with partitions having a fire resistance rating of at least one hour. LSC 10-1341, 10-2321, 10-2322, 10-2324.

In the event of an interruption in normal lighting, the facility must provide emergency lighting of at least one hour. LSC 5-102, 10-1293, 10-1294, 10-2273.

If a facility is not in substantial compliance with program requirements, CMS has the authority to impose one or more of the enforcement remedies listed in 42 C.F.R. � 488.406, which include imposing a CMP. See Act, section 1819(h). CMS may impose a CMP for the number of days that the facility is not in substantial compliance with one or more program requirements or for each instance that a facility is not in substantial compliance. 42 C.F.R. � 488.430(a). In situations where the deficiencies do not constitute immediate jeopardy, but have caused actual harm or have the potential for more than minimal harm, CMS may impose a CMP in the range of $50 to $3,000 per day. 42 C.F.R. � 488.438(a)(ii).

IV. Discussion

A. Because Petitioner's deficiencies posed the potential for more than minimal harm, the facility was not in substantial compliance with program requirements, and I have no authority to review CMS's decision to impose a remedy. ⁽²⁾

Petitioner offers virtually no evidence to refute CMS's findings of substantial noncompliance except as to the one tag (F314) that was cited at scope and severity level "G" (actual harm that is not immediate jeopardy). Instead, Petitioner asserts that Tag F314 (quality of care - pressure sores) "is the only tag that reasonably justifies any substantive CMP if it is sustained." P. Br. at 2. Petitioner also suggests that penalties are justified only if a deficiency "implicates actual harm or a potential for serious harm." Id. This simply is not the regulatory standard. The regulation defines "substantial compliance" as a level of compliance with participation requirements 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. Thus, if deficiencies pose the potential for more than minimal harm, the facility is not in substantial compliance and CMS has the discretion to impose one or more of the enforcement remedies listed in 42 C.F.R. � 488.406, including imposing a CMP. Act, section 1819(h); 42 C.F.R. � 488.402. The regulations then limit my authority to review CMS's selection of remedies for a substantially non-compliant facility. I may not review CMS's exercise of its discretion to impose the CMP. 42 C.F.R. �� 488.408(g)(2) (a facility "may not appeal the choice of remedy, including the factors considered by CMS or the State in selecting the remedy. . ."); 488.438(e) (if an ALJ finds a basis for imposing a CMP, he/she may not review CMS's exercise of its discretion to do so). So long as CMS establishes one "D" level deficiency - defined as an isolated instance of no actual harm with the potential for more than minimal harm - it may impose a penalty. If the penalty CMS selects is a per day CMP, the amount must be at least $50 per day. 42 C.F.R. � 488.438(e)(1).

1. From June 13-20, 2002, Petitioner was not in substantial compliance with the Life Safety Code.

CMS found substantial noncompliance with certain life safety code requirements. Petitioner offers little evidence or argument to refute CMS's claims except to point to its plan of correction and assert that it corrected those LSC deficiencies between June 11 and June 20. P. Br. at 1, n.1. CMS appears to concede that the facility completed its LSC corrections on June 20. CMS Reply at 9-10. The parties thus agree that the facility was not in substantial compliance with the LSC, and its noncompliance continued through June 20, 2002. ⁽³⁾ If so, the facility achieved substantial compliance with the LSC on June 21, 2002, the date CMS maintains the facility achieved substantial compliance with all program requirements. On these LSC deficiencies alone, CMS may therefore impose a remedy and, as discussed above, I have no authority to review its decision to impose a CMP.

I note also that these LSC deficiencies are not the trifling problems that Petitioner suggests. The surveyors found a pattern of noncompliance presenting the potential for more than minimal harm (scope and severity level "E"). Indeed, the potential for serious harm is substantial where the facility's interior walls are not sufficiently fire-resistant. Such deficiencies not only justify the imposition of a CMP, but, by themselves, justify the imposition of CMP that is higher than the mandatory minimum.

2. From June 13-20, 2002, Petitioner was not in substantial compliance with 42 C.F.R. � 483.20(k)(3)(i), which requires that services meet professional standards of quality.

As noted above, services provided or arranged by the facility must meet professional standards of quality. 42 C.F.R. � 483.20(k)(3)(i). In reviewing a medical record for Resident 17 (R17), Surveyor Lou Ann Davis observed what CMS characterizes as a dangerously confusing physician order, not meeting professional standards of quality. In reviewing a medical record for Resident 40 (R40), Surveyor Davis found a confusing and contradictory series of physician orders. After she questioned staff, a charge nurse, on her own, discontinued R40's PRN medication orders, another violation of the nursing standard, according to CMS.

R17. R17 was diagnosed with dementia, depression, and Alzheimer's disease with agitation. CMS Ex. 63, at 2 (Davis Declaration (Decl.) � 5). A physician order dated September 4, 2001, prescribed both tablet and liquid Lorazepam (the generic form of Ativan) as follows:

Lorazepam 0.5MG (1/2=0.25MG) - Generic For - Ativan 0.5MG Tab (1/2=0.25): 1/2=0.25MG PO BID

Lorazepam Intensol 2MG/ML: 0.125cc=0.25MG BID

CMS Ex 17, at 1. ⁽⁴⁾

CMS argues that this order could be interpreted to mean that both tablet and liquid forms of the drug should be administered twice a day. If so, this would be double the recommended dose. CMS Ex. 63, at 3 (Davis Decl. � 5). Surveyor Davis, who is a registered nurse, opines that standard nursing practice requires immediate clarification of such orders, since staff's interpreting it literally would result in potentially harmful over-medication. Id. At the surveyor's urging, facility staff contacted R17's physician who wrote a new order clarifying that staff should administer either Lorazepam tablets or Lorazepam liquid, but not both. See CMS Br. at 9; CMS Ex. 17, at 2-3; CMS Ex. 63, at 4 (Davis Decl. � 7).

Surveyor Davis also reviewed R17's Medication Administration Record (MAR), which showed that the nurses were administering both forms of Lorazepam at the same time. Staff initials appeared under the order for Lorazepam tablets - indicating that the dose had been administered - and under the order for Lorazepam liquid - indicating the liquid dose had also been administered. CMS Exs. 15; 63, at 3-4 (Davis Decl. � 6). According to Surveyor Davis, staff "had been blindly initialing that both forms of the medication had been administered to R17 when, in fact, only one had." CMS Ex. 63, at 4 (Davis Decl. � 6). Indeed, R17's controlled substance record confirmed that nurses had administered only one dose of Lorazepam at a time. CMS Exs. 15; 16; 63, at 3-4 (Davis Decl. � 6). After Surveyor Davis questioned the nursing staff about the record of apparent double-dosing, someone wrote "OR" between the two orders, and, at Surveyor Davis's suggestion, circled the initials which had incorrectly recorded the administration of Lorazepam liquid, to show that the medication had not been given. CMS Exs. 15; 63, at 3-4 (Davis Decl. � 6). Surveyor Davis opines that staff violated standard nursing practice by documenting that they administered medication which they had not administered. Id. at 4 (Davis Decl. � 8).

R40. Nor were these the only violations of nursing standards reported by Surveyor Davis. R40 was diagnosed with dementia and psychosis, and had three physician orders for Lorazepam. CMS Exs. 18, at 1-2; 63, at 4-5 (Davis Decl. � 9). On March 14, 2002, the facility's pharmacist recommended reducing the ordered dosages. CMS Exs. 19; 63, at 5 (Davis Decl. � 10). Apparently, R40's treating psychiatrist did not agree, noting on a March 29, 2002 behavioral progress note that R40 was doing well on the ordered dosage. CMS Ex. 20. ⁽⁵⁾ However, the psychiatrist apparently was not aware that the resident had three separate orders for the medication. Staff had listed only one regular dose of the drug, and omitted two PRN (as needed) orders. CMS Exs. 20; 63, at 5-6 (Davis Decl. � 11). At the same time, R40's primary physician, who apparently agreed with the pharmacist's recommendation, ordered the drug reduced, and then discontinued. CMS Exs. 19; 63, at 6 (Davis Decl. � 12). It appears that the physicians were not aware of their conflicting orders. In any event, neither order was completely followed. R40's regular drug dose was discontinued on March 29, 2002, but the PRN orders remained on the monthly order sheet, and were signed by R40's primary physician. CMS Exs. 18, at 4; 63, at 6 (Davis Decl. � 12). In response to Surveyor Davis's questions about continuing the PRN orders, the charge nurse, on her own, without consulting either physician, discontinued the medication orders, which Surveyor Davis considers another violation of standard nursing practice. CMS Ex. 63, at 6 (Davis Decl. � 12).

Petitioner does not dispute Surveyor Davis's factual allegations nor her opinion that the staff's actions here violated standard nursing practice. Instead, Petitioner argues that no harm resulted from the violation, and that any risk of harm "was obviated by 6/12/02, the day before the CMP period began." P. Br. at 3 (emphasis original).

As discussed above, CMS does not have to show actual harm in order to establish a facility's substantial noncompliance. Here, with respect to R17, the physician orders appeared to have called for twice as much sedative as the physician intended, and the nurses recorded that they administered the double doses. Not only are these poor practices, but, as Surveyor Davis explained, the confusing order placed R17 at risk of being over-medicated. Staff's recording errors as to the actual administration of the drugs created a second potentially risky situation because the facility had no reliable account as to the amount of drug actually administered. From the series of orders for R40, CMS rightly concluded that it is impossible to determine what her physicians intended with respect to the administration of Lorazepam. Nursing staff's failure to clarify those ambiguous and conflicting orders, as well as the charge nurse's unilateral action in discontinuing the PRN orders without physician notification again put R40 at risk of either not getting drugs her physician deemed appropriate, or being administered drugs that he determined she should not receive.

I reject Petitioner's claim that the facility corrected this deficiency before the date of the CMP. Because this deficiency had the potential for more than minimal harm, the facility was presumed to be out of compliance "from the date of completion of the survey in which [it was] cited until the date of the resurvey in which substantial compliance was established." Lake City Extended Care Center, DAB No. 1658, at 14-15 (1998). To achieve substantial compliance, the facility must correct the specific cited instances of substandard care, demonstrate that no other instances have occurred, and implement a plan of correction designed to assure that no such incidents occur in the future. Here, as CMS points out, the corrective action to which Petitioner refers - contacting the physician for clarification, and correcting R17's MAR to reflect the medications actually administered - did not wholly correct the deficiency. See CMS Reply at 7-8. As part of its plan of correction, the facility conducted in-service training on June 20, 2002, addressing "drug regimen review and clarification of physician telephone order." CMS Ex. 8, at 2. The facility also implemented a new Quality Assurance (QA) Study designed to insure that nursing staff record complete and accurate physician orders. Id. The QA began on June 17, to be performed daily for two weeks, after which its frequency would be reassessed. Id. CMS thus reasonably concluded that the deficiency was not corrected before June 21, 2002. See Asbury Center at Johnson City, DAB No. 1815, at 20 (2002) ("a facility's return to substantial compliance must usually be established through a resurvey. . . "); Hermina Traeye Memorial Nursing Home, DAB No. 1810, at 13 (2002) (burden is on the facility to prove that it has resumed complying with program requirements, not on CMS to prove that deficiencies continued to exist after they were discovered).

3. From June 13-20, 2002, Petitioner was not in substantial compliance with 42 C.F.R. � 483.75(j), which requires the facility to provide or obtain laboratory services that meet resident needs.

The regulation governing effective administration requires, among other things, that facilities provide or obtain laboratory services to meet resident needs. 42 C.F.R. � 483.75(j).

R48. Surveyor Virginia Martin reviewed Resident 48's (R48's) medical records. R48 suffered from Huntington's disease, and was prescribed the drug, Clonazepam. CMS Ex. 65, at 2 (Martin Decl. � 5). Because Clonazepam can adversely affect the liver, on July 10, 2002, her physician ordered liver function studies every three months. CMS Ex. 65, at 2-3 (Martin Decl. �� 5, 6). See also CMS Ex. 31, at 3-4. In an entry dated January 8, 2002, R48 's plan of care required liver function monitoring as ordered by her physician, with the results reported to her physician. CMS Exs. 31, at 4; 65, at 3 (Martin Decl. � 7). But R48's records showed that liver function studies were not performed as ordered. The tests were performed on July 26, 2001; less than a month later, on August 9, 2001; but the next test was not performed until six months later, February 6, 2002. CMS Ex. 31, at 4. The February 6 test was apparently R48's last recorded liver function test, so, at the time of the June survey, she had not been tested for four months. CMS Ex. 65, at 3 (Martin Decl. �� 6, 7).

R58. Surveyor Nancy Krouse reviewed Resident 58's (R58) medical records. CMS Ex. 64, at 6 (Krouse Decl. � 16). R58 was diagnosed with hypothyroidism, for which her physician prescribed synthyrod. Id. The physician also ordered lab tests for thyroid stimulating hormone (TSH) and thyroxin (T4) every six months. Id. See also CMS Ex. 32, at 4. R58's record showed that the ordered tests had last been performed on November 10, 2001, more than seven months earlier. CMS Ex. 64, at 6 (Krouse Decl. � 16); CMS Ex. 32, at 4.

R1. Finally, Surveyor Davis reviewed Resident 1's (R1) medical records. CMS Ex. 63, at 8 (Davis Decl. � 18). R1 was diagnosed with anemia, which was treated with iron. Her physician ordered blood counts at regular intervals. Id. In a consultation dated January 24, 2002, the facility's pharmacist recommended that her physician consider discontinuing the iron therapy based on her latest lab results. CMS Ex. 34. Her physician, however, ordered that the therapy continue, and that another complete blood count be performed two months later. Id. The test was not performed until almost five months later, on June 11, 2002. CMS Exs. 33; 34; 63, at 8-9 (Davis Decl. � 18).

Again, Petitioner does not dispute these allegations, but asserts that no harm resulted, and that any risk of harm "was obviated by obtaining testing on either 6/11/02 or 6/12/02," before the imposition of the CMP. P. Br. at 5; see also P. Ex. 11, at 4-5 (McMaster Decl. �� 15, 16, 17). ⁽⁶⁾ As explained above, substantial noncompliance does not require a showing of actual harm. 42 C.F.R. � 488.301. Here, these residents' treating physicians ordered laboratory testing at specific intervals for important medical reasons, and the facility's failure to follow those orders unquestionably created the potential for more than minimal harm. See CMS Exs. 63, at 8-9 (Davis Decl. �� 18, 19); 64, at 6-7 (Krouse Decl. �� 16, 17, 18); 65, at 3-4 (Martin Decl. �� 6, 7, 8, 9, 10).

Nor do I agree that the facility resolved this deficiency by finally obtaining the ordered tests on June 11 and 12. I have discussed above the presumption of continuing noncompliance, and the requirement that a substantially deficient facility implement a plan of correction designed to assure that instances of substandard care not recur. Here, the facility's repeated failure to obtain lab tests as ordered shows a systemic problem, whose correction went beyond obtaining tests for these particular residents. The facility developed new lab tracking procedures, implemented a quality assurance study on June 18, to be completed two weeks later, and provided in-service training to all nurses on June 20, 2002. CMS Ex. 8, at 7. The facility has not shown that these actions were fully implemented - much less that they successfully resolved its problems - prior to June 21, 2002.

4. Because of its practices in treating residents at risk of developing pressure sores, and in treating those who developed pressure sores, Petitioner was not in substantial compliance with 42 C.F.R. � 483.25(c) from June 13-20, 2002.

I next address the sole deficiency that Petitioner seriously challenges: the facility's alleged noncompliance with 42 C.F.R. � 483.25(c)(Quality of Care - pressure sores). ⁽⁷⁾ In assessing the facility's compliance with this requirement, the relevant question is: did the facility "take all necessary precautions" to prevent new sores from developing, and, if they nevertheless develop, to promote healing and prevent infection. 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, then the regulation is violated. Koester Pavilion, DAB No. 1750, at 32 (2000).

R40. In addition to her mental impairments, R40 had diagnoses of diabetes, obesity, hypertension, and congestive heart failure. CMS Exs. 6, at 6; 27, at 1. She was dependent on staff for transfers, bed mobility, dressing, eating, and other activities of daily living. CMS Ex. 6, at 6. The facility identified her as at risk for pressure sores and had developed for her a plan of care to prevent them. P. Ex. 5, at 1. A physician's order, dated May 4, 2002 (and signed by the physician on May 6, 2002), calls for heel protectors while in bed. P. Ex. 5, at 5, 9. The requirement that she have heel protectors while in bed, as ordered by her physician, was added to her care plan on May 11, 2002. P. Ex. 5, at 1. However, on June 12, 2002, at 9:50 a.m., Surveyor Davis observed that R40 had been put to bed without heel protectors. CMS Ex. 63, at 7 (Davis Decl. � 15). They were left lying at the foot of her bed outside the covers. Id. Five minutes later two surveyors observed that the heel protectors were still there outside the covers. CMS Exs. 6, at 6-7; 27, at 8; 63, at 7 (Davis Decl. � 15).

Petitioner does not challenge the surveyors' observations, but suggests that this lapse caused no harm. Although R40 had an open sore on her right toe, Petitioner claims this was not a pressure sore but an unavoidable diabetic ulcer, which heel protectors would not have prevented. P. Br. at 4; P. Ex. 10, at 2-3 (Writesel Decl. � 9). CMS disputes this characterization, arguing that R40 had a pressure sore on her great toe, that her physician ordered the heel protectors in response, and that heel protectors not only protect heels, but lift toes from the mattress, affording protection to toes as well as heels. CMS Br. at 21-22. I need not resolve this dispute in order to find substantial noncompliance here.

Assuming that the open sore on R40's toe was an unavoidable diabetic ulcer, unrelated to whether facility staff applied heel protectors as ordered, CMS has nevertheless established that the facility was not taking necessary steps to prevent R40 from developing pressure sores. The facility here identified R40 as at risk, and, based on its own assessment and plan of care, as well as her physician's order, determined that she required heel protectors while in bed in order to prevent the development of pressure sores. The facility's failure to follow the physician's order and its own care plan created the potential for more than minimal harm to this resident and constitutes substantial noncompliance, without regard to whether she developed a pressure sore as a direct result of staff's failures. Koester Pavilion, DAB No. 1750; see also Crestview Parke Care Center v. Thompson, 373 F.3d 743, 753 (6^th Cir. 2004) (Court emphatically rejects the facility's argument that physician-ordered heel protectors were unnecessary).

R 53. R53 was diagnosed with diabetes, obesity, chronic obstructive pulmonary disease, and arteriosclerotic heart disease. CMS Exs. 6, at 4; 64, at 2 (Krouse Decl. � 5). He was incontinent, unable to walk, and required the assistance of two people to transfer from bed to chair. CMS Ex. 64, at 2 (Krouse Decl. � 6). The facility identified him as at risk for pressure sores, and, in his plan of care, proposed some interventions to prevent them: pressure reduction mattress, turning him in bed every two hours, and propping him with pillows while in bed. CMS Exs. 23; 64, at 3 (Krouse Decl. � 8); P. Ex. 6, at 1.

CMS points out a serious problem with the facility's approach - all interventions addressed R53's vulnerability while in bed, but he spent most of his time up in his recliner chair and some of his time sitting in a wheel chair. CMS Exs. 21, at 4; 64, at 3-6 (Krouse Decl. �� 7, 12, 14). A resident who is at risk for developing pressure sores should have pressure relief from any surface he sits on. CMS Ex. 65, at 5-6 (Martin Decl.� 13). Here, the facility had no plan to protect R53 from developing pressure sores while he was out of bed, sitting up - which is where he spent most of his time.

According to Surveyors Krouse and Martin, who are both registered nurses and are trained in pressure sore prevention and treatment, use of pressure relieving chair pads and periodic repositioning are standard preventive measures for individuals such as R53, who spend significant amounts of time sitting. CMS Exs. 64, at 1, 3 (Krouse Decl. �� 2, 8); 65, at 1, 5-6 (Martin Decl. �� 2, 13).

Petitioner argues that R53 had no need for a pressure-relieving device in either his wheelchair or his recliner. In fact, Kenneth Writesel, D.O., the facility's medical director and R53's primary physician, characterizes the idea of placing a gel cushion in a reclining/lift chair as "ridiculous at best," because it presents safety hazards. P. Ex. 10, at 2 (Writesel Decl. � 6). Further, according to Petitioner, R53 did not spend enough time in his wheelchair to merit any intervention, and his recliner was "a pressure relieving chair, with special pressure-relieving properties." P. Br. at 3-4; P. Ex. 11, at 2-3 (McMaster Decl. �� 7-9).

I do not accept Petitioner's largely unsupported claim about R53's recliner having "special pressure-relieving properties." Petitioner's sole support for this claim is a statement by the facility's director of nurses. She does not explain what makes this particular chair special. Petitioner submits a photograph of the chair, and it appears to be a standard recliner/lift chair. P. Ex. 12. Presumably, a manufacturer whose chair possessed such qualities would include that information in its literature, but Petitioner offers no literature from the manufacturer or anyone else supporting the claim. Moreover, no one else has made that assertion. Staff did not tell the surveyors that the chair had special properties. R53's care plan says nothing about the chair as an intervention to prevent skin break-down. The facility did not mention in its plan of correction that R53's recliner had pressure-relieving capability. I therefore find the statement unsupported and not credible.

I need not resolve the question as to the reasonableness of putting a gel cushion in R53's recliner chair. A facility has wide latitude to determine which interventions are appropriate in preventing pressure sores, and might well determine that a gel cushion is not appropriately used in a recliner. However, R53 was at high risk. He spent the bulk of his day sitting in chairs, and the facility had no interventions in place to protect him from developing a pressure sore as a result of his long periods spent sitting. Although Petitioner points to the facility's Occupational Therapy (OT) Department's conclusion that a gel cushion in R53's recliner was contraindicated, the OT Department did not even consider appropriate interventions until June 14, 2002, after the date of the survey. P. Ex. 6, at 6. If a gel cushion was not the appropriate solution, it was nevertheless incumbent on the facility to implement other, more appropriate interventions.

After R53 developed pressure sores on his coccyx the facility finally considered some interventions to protect R53 while he sat. A June 3 "Post Skin Wound Summary" lists two new preventive measures: gel cushion when up in his wheelchair every day, and "monitor reposition" change every two hours and as needed. CMS Ex. 24. However, on June 11, Surveyor Krouse saw no such gel cushion, and asked about it. CMS Ex. 64, at 4 (Krouse Decl. � 10). Only then did R53's physician order the cushion. P. Ex. 6, at 3. Again, Petitioner challenges neither the observation nor the conclusion. And, following its June 14 evaluation, the OT Department again suggested that R53 be given that pressure relief every two hours, which appears to be a reasonable intervention that was not in place earlier. P. Ex. 6, at 6.

The facility's failure to intervene earlier shows that it was not making the required efforts to prevent the development of pressure sores.

The evidence in the record is not wholly consistent as to when R53's pressure sores were discovered, when assessed, and when treatment started. The most reliable evidence shows that staff observed the wound, notified the physician, and started treatment on June 1. Nurses notes written at 10:00 p.m. on June 1, 2002, describe an open area on the coccyx. P. Ex. 6, at 9. That note says "faxed" physician and "tx (treatment) ordered." P. Ex. 6, at 9; CMS Ex. 26, at 1. Copies of what appear to be faxes are in the record. One is a note dated 6/1/02 identifying the resident and his physician, and stating "open area on buttocks[;] Tx. Started" whose fax information indicates it was sent at 10:39 p.m. on June 1. P. Ex. 6, at 2. The second is a physician order, also dated 6/1/02, stating "clean buttocks [with] H�O [and] soap[;] apply onsite Q [every] 3 days [check] PRN." It indicates that it was sent on June 1, 2002, at 10:54 p.m. Id. ⁽⁸⁾

On the other hand, no evidence suggests that the wound was measured or otherwise assessed until June 3, 2002, when staff completed a form titled "Post Wound Summary." CMS Exs. 24; 64, at 3-4 (Krouse Decl. � 9). Surveyor Krouse opines that such a delay violates the nursing standard of care. CMS Ex. 64, at 3-4 (Krouse Decl. � 9). A pressure sore should be assessed as soon as it is identified, and the treating physician should be advised of its size and depth. Id. Petitioner does not challenge Surveyor Krouse's observation or her opinion.

Thus, notwithstanding the facility's recognition that R53 was at high risk and that he spent significant time sitting, the facility had no interventions in place to protect R53 from developing pressure sores while he was sitting. When R53 developed a pressure sore, facility staff impermissibly delayed measuring and assessing the wound. And, even though the facility decided on June 3, 2002, that a gel cushion should be put in R53's wheelchair, the staff did not implement that intervention until more than a week later, when the surveyor brought it to their attention. Based on all of this, I find that the facility was not taking necessary steps to prevent R53 from developing pressure sores.

B. I find reasonable the $400 per day CMP, which is at the low end of the CMP range for non-immediate jeopardy situations.

Aside from its claims regarding compliance, Petitioner is silent as to the reasonableness of the CMP amount, and I am not convinced that it has preserved the issue. In any event, the penalty is small and well-justified by the circumstances presented.

As noted above, if CMS determines that a facility is not in substantial compliance with program requirements, it may impose a CMP for each day of substantial noncompliance. Act, section 1819(h); 42 C.F.R. � 488.402; 42 C.F.R. � 488.408. Where the deficiencies do not pose immediate jeopardy to resident health and 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 low end of the 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; and 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. 42 C.F.R. � 488.438(f). The factors in 42 C.F.R. � 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.

With respect to facility history, CMS presents evidence, which Petitioner does not challenge, establishing the facility's significant history of noncompliance, both generally and with reference to the deficiencies found during the survey here. During the 2001 annual survey, the facility had thirteen deficiencies, including failure to meet professional standards of quality, cited here. CMS Ex. 3, at 1. It also had four LSC deficiencies. So the facility's poor history justifies an increased CMP. Id. at 2.

Petitioner has not claimed that its financial condition prevents it from paying this small penalty.

Applying the remaining factors, I note that the deficiencies cited were not trivial. As the above discussion establishes, the facility had systemic problems in a number of areas that threatened resident comfort, health and safety, and for which the facility is culpable. This conclusion, along with the facility's substandard history, more than justifies the small monetary penalty imposed.

V. Conclusion

For all of the reasons discussed above, I uphold CMS's determination that Petitioner was not in substantial compliance with program participation requirements from June 13-20, 2002, and find reasonable the amount of the CMP imposed, $400 per day for 8 days (total $3,200).

Carolyn Cozad Hughes

Administrative Law Judge

1. "Flame Spread Rating" is a rating of the propagation of flame over a surface.

2. I make findings of fact and conclusions of law to support my decision. I set forth each finding, in italics, as a separate heading.

3. I note that, as part of the facility's plan of correction, a Quality Assurance Program was implemented June 18, to be completed "daily for the next two weeks." See CMS Ex. 8, at 10; P. Ex. 3, at 11. CMS could justifiably have found substantial compliance only upon the facility's completion of that program, two weeks later.

4. "PO" means by mouth. "BID" means twice a day.

5. In the March 29, 2002 progress note, the psychiatrist made a check mark next to the phrase "Dosage reduction is contraindicated due to: (check all that apply). . . ." CMS Ex. 20. He also made a check next to the phrase "Resident is on an optimal dose and is clinically stable." Id. There is a handwritten note under "Plan" that I find illegible. It is possible that the note reads "[decrease] meds and follow." Id. If so, then the note and the checked phrases would be inconsistent, which would raise a duty on the part of the nursing staff to clarify the psychiatrist's orders.

6. In addition, the facility apparently contacted R48's physician, who changed his order for testing from every three months to every six months.

7. I note that the deficiencies that Petitioner did not seriously contest (Life Safety Code, 42 C.F.R. �� 483.20 and 483.75) provided CMS a basis for imposing a per day CMP, and, by themselves, could well be found to justify the relatively low CMP imposed in this case, particularly when considered in conjunction with other factors, such as facility history. See discussion below.

8. Other facility records, "Active Skin Problem Plan of Care" and "Pressure Ulcer Progress Report," give June 2 as the "initiation date" of the pressure sore. CMS Exs. 22, 25. However, I find these in error.