SUBJECT:

Tri-County Extended Care Center,

Petitioner,

Centers for Medicare & Medicaid Services.

DECISION

I sustain the determination of the Centers for Medicare & Medicaid Services (CMS) to impose a civil money penalty (CMP) against Petitioner, Tri-County Extended Care Center, for failure to comply substantially with federal requirements governing participation of long-term care facilities in Medicare and State Medicaid programs. The CMP of $400 per day imposed by CMS from December 14, 2001 through January 30, 2002, is based on a finding of isolated deficiencies, some of which constituted actual harm, that was not immediate jeopardy. I uphold CMS's determination to impose a CMP of $400 per day.

I. Background

This case came before me pursuant to a May 8, 2002 request for hearing by Petitioner, in accordance with section 1128A(c)(2) of the Social Security Act (Act) and 42 C.F.R. �� 488.408(g), 498.40.

On February 2, 2002, CMS informed Petitioner that, based on the recommendation of the Ohio Department of Health, it was imposing a CMP in the amount of $400 per day effective December 14, 2001, until necessary corrections to achieve substantial compliance with participation requirements were made or the provider agreement was terminated. CMS Ex. 1.

At the hearing held in Cincinnati, Ohio, on April 26 - 27, 2005, CMS offered 40 exhibits identified as CMS Exs. 1 - 40. Petitioner offered 12 exhibits identified as P. Exs. 1 - 8 and 10 - 13. The parties' exhibits were admitted into evidence without objection. In this decision I refer to three items from the record in this case as ALJ Exs. 1 - 3: my April 21, 2005 Amended Order (ALJ Ex. 1); Petitioner's December 2, 2002 List of Witnesses (ALJ Ex. 2); and Petitioner's April 22, 2005 Compliance with ALJ's Orders of April 19, 20 and 21, 2005 (ALJ Ex. 3).

Subsequent to the hearing, the parties submitted simultaneous post hearing briefs (CMS Br. and P. Br.), as well as response briefs (CMS Response and P. Response).

Based on the testimony offered at the hearing, the documentary evidence, the arguments of the parties, and the applicable law and regulations, I find that from December 14, 2001 through January 30, 2002, Petitioner was not in substantial compliance at the less than immediate jeopardy level. I further find that CMS was authorized to impose a CMP against Petitioner at the rate of $400 per day during the above period of noncompliance.

In its post-hearing brief Petitioner submitted a proffer of testimony regarding four witnesses that were allegedly prevented from testifying because of the order I issued on April 19, 2005, directing the parties to provide a written summary of their expert witnesses' qualifications and opinions. ⁽¹⁾ My Amended Order reflects that this case was previously scheduled for a hearing on June 22, 2004. ALJ Ex. 1. That hearing, however, was continued pursuant to an unopposed emergency motion filed by CMS on June 18, 2004, just four days prior to the hearing. At that time Petitioner had announced 33 witnesses, none of which was identified as an expert witness. ALJ Ex. 2. I infer that at the time of the continuance of the June 2004 setting, Petitioner had met with and interviewed all of the witnesses that would be called on to testify. Thus, when Petitioner revealed for the first time, on April 19, 2005, that it would call certain witnesses to testify as experts, it should not have been an insurmountable burden to provide summaries of their qualifications and opinions. In fact, in spite of employing time in the preparation of several motions in opposition to my directives, Petitioner was still able to comply with my order. See ALJ Ex. 3. In its submission of compliance Petitioner provided expert witness resumes for four nurses employed by the facility. ⁽²⁾ No other purported experts were included in the summaries nor did Petitioner offer to present the testimony of the four witnesses mentioned in the post hearing proffer. In fact, Petitioner did not call all of the experts whose summaries were submitted in compliance with my order of April 19, 2005, nor did Petitioner mention during the course of the hearing that it would have called other experts, ⁽³⁾ but for my April 19, 2005 order. Petitioner appears to claim that I prevented the four experts included in the proffer from testifying. However, Petitioner did not offer their testimony at the hearing nor did it indicate that it had an interest in presenting the testimony of other experts in addition to those submitted in compliance with my April 19, 2005 order. In view of the foregoing it is my conclusion that the proffer of additional testimony at this late juncture is untimely. Even if I were to consider that testimony, it would have no bearing on the outcome of this case. In fact, such testimony would be duplicative. Similar testimony was offered by other witnesses who also tried to justify that it was appropriate for the facility to ignore the physician's treatment orders. Neither the testimony presented by Petitioner at the hearing nor that which is now offered addresses the crucial issue of the actions taken to comply with the treating source orders, facility policy, and care plan.

Petitioner also takes issue with my rulings during the course of the hearing as well as the questions I posed to witnesses in my role as fact finder. However, Petitioner does not indicate the import of those allegations nor the purpose for which those matters are referenced, except to maintain that there is a demonstration of a bias to CMS. Likewise, Petitioner's assertion that it reviewed 27 of my prior decisions and found that in none of those decisions was there a finding against CMS is also of no value in addressing the issues of this case. ⁽⁴⁾ P. Br. at 28. Should Petitioner's purpose be a renewal of prior motions for my recusal, the same is hereby denied, as I harbor no bias against its facility, and consider myself completely capable of rendering a fair decision based on the law and the facts of the case.

II. Applicable Law and Regulations

Petitioner is considered a long-term care facility under the Act and regulations promulgated by the Secretary of the Department of Health and Human Services (Secretary). The statutory requirements for participation by a long-term care facility are found at sections 1819 and 1919 of the Act, and at 42 C.F.R. Part 483.

Sections 1819 and 1919 of the Act invest the Secretary with authority to impose certain remedies, including CMPs and denial of payment for new admissions, against a long-term care facility for failure to comply substantially with participation requirements.

Pursuant to the Act, the Secretary has delegated to CMS and the States the authority to impose remedies against a long-term care facility that is not complying substantially with federal participation requirements. 42 C.F.R. Part 483 provides that facilities which participate in Medicare may be surveyed on behalf of CMS by State survey agencies in order to ascertain whether the facilities are complying with participation requirements. 42 C.F.R. �� 488.10 - 488.28. The regulations contain special survey conditions for long-term care facilities. 42 C.F.R. �� 488.300 - 488.335. Under Part 488, a State or CMS may impose a CMP against a long-term care facility where a State survey agency ascertains that the facility is not complying substantially with participation requirements. 42 C.F.R. �� 488.406, 488.408, 488.430. The penalty may start accruing as early as the date that the facility was first out of compliance until the date substantial compliance is achieved or the provider agreement is terminated.

The regulations specify that a CMP that is imposed against a facility will fall into one of two broad ranges of penalties. 42 C.F.R. �� 488.408, 488.438. The upper range of civil money penalties, of from $3,050 per day to $10,000 per day, is reserved for deficiencies that constitute immediate jeopardy to a facility's residents, and in some circumstances, for repeated deficiencies. 42 C.F.R. �� 88.438(a)(1) and (d)(2). The lower range of civil money penalties, of from $50 per day to $3,000 per day, is reserved for deficiencies that do not constitute immediate jeopardy, but either cause actual harm to residents or cause no actual harm, but have the potential for causing more than minimal harm. 42 C.F.R. � 488.438(a)(2).

The regulations define the term "substantial compliance" to mean:

[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.

In determining the amount of the CMP, the following factors specified at 42 C.F.R. � 488.438(f) must be considered:

1. The facility's history of noncompliance, including repeated deficiencies.

2. The facility's financial condition.

3. The seriousness of the deficiencies as set forth at 42 C.F.R. � 488.404

4. The facility's degree of culpability.

In a CMP case, CMS must make a prima facie case that the facility has failed to comply substantially with participation requirements. To prevail, a long-term care facility must overcome CMS's showing by a preponderance of the evidence. Hillman Rehabilitation Center, DAB No. 1611 (1997).

The Act and regulations make a hearing before an Administrative Law Judge available to a long term facility against whom CMS has determined to impose a CMP. Act, section 1128A(c)(2); 42 C.F.R. �� 488.408(g), 498.3(b)(12), (13). The hearing before an Administrative Law Judge is a de novo proceeding. Anesthesiologists Affiliated, et al., DAB CR65 (1990), aff'd 941 F.2d 678 (8^th Cir. 1991).

III. Issues

A. Whether the facility was complying substantially with federal participation requirements on the dates CMS determined to impose a CMP.

B. Whether the amount of the penalty imposed by CMS is reasonable, if noncompliance is established.

IV. Findings and Discussion

The findings of fact and conclusions of law noted below in italics are followed by a discussion of each finding.

A. The facility was not in substantial compliance with federal participation requirements from December 14, 2001, through January 30, 2002.

1. The facility failed to provide the necessary care for a resident with a suprapubic catheter.

a. State surveyor findings for Tag F309, as alleged in the Statement of Deficiencies (CMS Ex. 3 at 4, 5 - Resident # 174 (R174).

Each resident must receive and the facility must provide the necessary care and services to attain or maintain the highest practicable physical, mental and psychosocial well being in accordance with the comprehensive assessment and care plan. 42 C.F.R. � 483.25.

Based on observation, clinical record review and facility staff interviews during the survey completed on December 14, 2001, it was determined that the facility failed to provide the necessary care for a resident with a suprapubic catheter.

On December 11, 2001, at 1:45 p.m., the resident was observed to have an abdominal suprapubic catheter in place. The catheter was noted to have brown purulent drainage around the site and a foul odor. Facility policy regarding suprapubic catheters stated the catheter was to be assessed every shift. Part of that assessment included cleansing the site. Record review, however, was silent as to any scheduled cleansing or treatment to the area. An interview with administrative staff on December 14, 2001 at 9:30 a.m., confirmed the area had foul drainage. Thus, a physician's order for cleansing the area three times a day was obtained.

Discussion

Petitioner contends that R174 did not have any mental, physical, or psychosocial harm based on anything the surveyor alleged in the Statement of Deficiencies. This assertion is based on the testimony of Lisa Ray, the assistant director of nursing. Ms. Ray testified that the characterization of a brown, foul, purulent drainage from the suprapubic site is not indicative of any infectious process. She added that such drainage would normally be brown and is usually present at the stoma site. Moreover, Ms. Ray noted that when a nurse makes an initial in a treatment chart or administrations record or something such as the medication administration record (P. Ex. 5, at 38, 42), it means that the service was delivered. Tr. at 391. Thus, she asserted that catheter care was provided to the resident during each shift as required by the facility policy. Petitioner also argues that it is inaccurate for the surveyor to conclude that no catheter care was provided to R174 based on an observation made at 10:00 a.m. because at that time the nurses would be completing their morning medication pass, which is a "time compliant task." It would not be expected that nurses would stop their medication pass to do treatments. A treatment (such as catheter care) may be performed at any time during the shift, because it is not a "time compliant task." P. Br. at 17, 18.

In order for Petitioner to be found non compliant with respect to Tag F309 under Quality of Care, it is not necessary that CMS establish that R174 showed evidence of an infectious process at the suprapubic site. The issue before me is whether the facility failed to provide the necessary care for a resident with a suprapubic catheter.

According to the facility's policy, residents with a suprapubic catheter were to be assessed every shift (twice daily). That assessment, as pertinent here, included:

�observing the site for redness, drainage, crusting, lesions or any other abnormalities;

�washing the four inches of the catheter tubing closest to the resident with soap and water, and thoroughly rinsing and completely drying the tubing afterwards;

�cleansing the catheter site with normal saline using cotton swab; and

�applying 4x4 sterile gauze.

This treatment was to be charted on the treatment sheet. CMS Ex. 31, at 10.

Ms. Ray's testimony that drainage is normal and not a reason for alarm is of no merit. In her estimation, she would be concerned only if she were to observe frank, purulent, green, yellow, very thick, really foul smelling drainage, or if there was frank bleeding from the stoma site. Tr. at 397, 398. She gave no persuasive explanation, however, as to why the thick, brown, foul smelling drainage observed by the surveyor would be of no concern. Tr. at 29, 30. On cross-examination, counsel for Petitioner attempted to establish that the surveyor may have mistaken the brown drainage for dried blood. However, the surveyor testified to a drainage and not a crusted substance such as dried blood. Tr. at 57. Ms. Berwanger testified that the amount of drainage she observed was an indication that the catheter site had not been cleansed, and that the drainage she observed posed a potential for infection. Tr. at 30, 47. The absence of catheter care as required by the care plan is also reinforced by information obtained from R174, a cognitively aware resident, to the effect that the staff changed the bag over, but performed no actual cleansing of the site. Tr. at 31, 32.

The evidence of record further reveals that drainage from the catheter site is not to be taken as lightly as Ms. Ray suggested in her testimony. In the first instance, I note that the facility suprapubic catheter care policy directs the staff to "observe the catheter site for redness, drainage, crusting, lesions, or any other abnormalities" (emphasis added). CMS Ex. 31, at 10. The directive to be on the alert for drainage is not qualified either qualitatively or quantitatively. That is, no exceptions are made based on appearance or amount of drainage. Any drainage is to be reported. See CMS Ex. 31, at 10, paragraph 6. Moreover, drainage is defined as an abnormality. If drainage of any type is considered an abnormality, there is no room for taking lightly a purulent, brown, foul smelling drainage. It is worthy of mention that neither the medication administration record nor any other record reflects that on December 11, 2001, R174's catheter site exhibited a thick, brown, purulent drainage, with an offensive odor. I infer from the absence of such mention that no assessment took place on that date.

Secondly, on those few occasions that the facility documented suprapubic catheter assessments, the presence of drainage was addressed by cleansing of the stoma site. When drainage was not present, the staff was careful to note that none was observed. Again I infer that the facility staff knew that the presence of drainage was an important aspect of suprapubic catheter assessment. CMS Ex. 20, at 37, 38, and 39.

Finally, when the treating physician was notified that R174 exhibited drainage at the catheter site, he ordered that it be cleansed with soap and water three times per day. He specifically cautioned the facility to monitor the stoma site for infection and purulent drainage. If the facility had, in fact, been cleansing R174's catheter site every shift as per the policy, it is not likely that the physician's order would have been necessary. Tr. at 398, 399; CMS Ex. 20, at 41. Ms. Ray testified that a member of the administrative staff did not feel that the resident exhibited a brown, purulent, foul smelling drainage. However, Ms. Ray herself did not observe the drainage noted by the surveyor nor was that staff person made available as a witness to refute the testimony of the surveyor. Tr. at 398. Thus, the testimony of surveyor Berwanger concerning her description of the suprapubic catheter site and the drainage that flowed from it remains uncontradicted. Moreover, inasmuch as the physician cautioned the facility to monitor the resident's stoma site for purulence and the facility staff appeared to be in denial of the purulent nature of the drainage present at R174's stoma site, I furthermore infer that staff did not report to the physician that the drainage experienced by the resident was in fact already purulent.

In view of the foregoing, I conclude that CMS has established a prima facie case that the facility failed to provide R174 with the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well being, in accordance with the comprehensive assessment and care plan. Specifically, the facility failed to provide the necessary care for a resident with a suprapubic catheter. 42 C.F.R. � 483.25. Petitioner has not overcome that showing by a preponderance of the evidence.

2. Pressure Sores (Tag F314) . The facility failed to provide necessary treatments to promote the healing of pressure sores, prevent infection and prevent new sores from developing.

a. State surveyor's findings for 42 C.F.R. � 483.25(c) as reflected at Tag F314 in the Statement of Deficiencies regarding Resident 107 (CMS Ex. 3, at 7, 8).

Section 483.25(c) of 42 C.F.R. requires that a facility must ensure that a resident who is admitted without pressure sores not develop them, unless the individual's clinical condition demonstrates that they were unavoidable; and a resident having pressure sores receives necessary treatment and services to promote healing, prevent infection and prevent new sores from developing.

Review of the clinical records for R107 revealed that he had been admitted to the facility on October 26, 2001, with medical diagnoses of chronic renal failure, diabetes mellitus, hypertension, anemia, Stage II ulcer on heels, and remote cerebral vascular accident. He was bedfast and required extensive assistance from staff for all aspects of care, including mobility.

The sore assessment dated October 29, 2001, indicated the resident was at high risk for the development of pressure sores. He was to be repositioned every two hours or whenever necessary.

When R107 returned to the facility on December 8, 2001 after a hospitalization, he was readmitted with a pressure sore on the left buttock measuring .75 centimeters in length and .5 centimeters in width. The pressure sore was described as superficially open with a scant amount of yellow drainage. On December 8, 2001, the physician ordered a hydrocolloid wafer (Tegasorb) to be applied every three to five days.

On December 11, 2001, at 8:12 a.m. and 8:54 a.m., the surveyor noted R107 to be on his back. Tr. at 85. Prior to personal care, at 9:34 a.m., the surveyor observed the resident still on his back. At that time, when the resident was turned for care, she noted a Stage II (open) pressure ulcer without any protective covering. At 10:32 a.m., the resident continued to be positioned on his back. During a meeting with administrative staff at 3:30 p.m., the surveyor made it known that the hydrocolloid wafer was not on, as ordered by the physician.

On December 12, 2001, at 8:22 a.m. and 8:52, the surveyor observed R107 lying on his back. At 9:55 a.m., upon entering the room with two treatment nurses, the surveyor observed the resident on his back. When he was turned on the side, it was noted that he was incontinent of stool and had no hydrocolloid wafer in place on the pressure sore. The nurses confirmed the absence of the wafer and lack of notification that the dressing was not in place. At that time, the wound had increased to 3 centimeters in length and 1.5 centimeters in width. After completing the treatment, the nurses positioned R107 on his back. Additional observations at 10:45 a.m. and 11:10 a.m. revealed the resident to still be lying on his back.

Petitioner contends that CMS was incorrect in the citation of a deficiency under Tag F314 with respect to R107 because there was no failure on the part of the facility to provide services to promote healing of the resident's pressure sore. In fact, argues Petitioner, the facility healed the pressure wound observed during the survey as well as previous wounds that R107 had acquired. P. Br. at 12, Tr. at 352-353.

Petitioner's argument here is without merit inasmuch as the facility is not charged with failing to heal R107's pressure sore, which was admittedly classified by the State Agency as unavoidable. ⁽⁶⁾ Additionally, the fact that the pressure sore was eventually healed does not negate the fact that the facility failed to provide the necessary treatment and services to promote healing and prevent new sores from developing. ⁽⁷⁾ This is evident from the Statement of Deficiencies as well as the testimony of the surveyor, Ms. Donna Cheatham. The surveyor stated that on the morning of December 11, and 12, 2001, she observed the resident to be lying on his back for more than two hours without repositioning. CMS Ex. 3 at 5-10, Tr. at 84, 85-88, 93, 94. She also noted that he was not wearing the hydrocolloid wafer that had been prescribed by the physician and designed to protect the wound, keep it moist, and help the debriding process.

Ms. Quanna Sheehan, a Licensed Practical Nurse, who testified on behalf of Petitioner, stated that the facility documented that R107 was repositioned every two hours and that he was combative and resistant to care (Tr. at 364, 384); that it would take less than one minute to reposition the resident, and that it was not necessary to have heel protectors with an air loss mattress ⁽⁸⁾ (Tr. at 365); and that R107 was receiving dialysis three times a week at a treatment center where he would have to lie down for eight to nine hours each session on a surface that had no pressure relieving device. Tr. at 356, 370, 371.

Petitioner also argues that since it would require less than one minute to reposition the resident, the surveyor may have missed that event. P. Br. at 14. I find that argument baseless. This argument is contradicted by Petitioner's allegation that the resident was repositioned every two hours. I note that on December 11, 2001, the surveyor observed the resident on his back at 8:12 a.m., 8:54 a.m., 9:34 a.m., and 10:32 a.m. Had the resident been repositioned at two-hour intervals, the surveyor would not have been able to observe him in the supine position during all of the observations made between 8:12 a.m. and 10.32 a.m. The same holds true for December 12, 2001, when the surveyor observed the resident on his back at 8:22 a.m., 8:52 a.m., 9:55 a.m., 10:45 a.m., and 11:10 a.m. Had the resident been repositioned at two-hour intervals, it would not have been possible for the surveyor to observe him in the supine position during all of the observations made between 8:22 a.m. and 11:10 a.m. Moreover, Petitioner has presented no evidence of probative value to refute the surveyor's observations that on the mornings of December 11 and 12, 2001, R107 was not repositioned as provided in the care plan, nor was a hydrocolloid wafer being applied as ordered by the treating physician. Ms. Sheehan was not present when the surveyor made the observations (Tr. at 375), she did not supervise the persons who were charged with R107's care, nor did she conduct an investigation regarding this citation. ⁽⁹⁾ Tr. at 383, 384. In fact, the testimony of the nurse or nurses entrusted with R107's care was not made available for my consideration.

In view of the foregoing, I find that CMS has established a prima facie case that Petitioner was in violation of 42 C.F.R. � 483.25(c). Petitioner has not overcome that showing by a preponderance of the evidence. I further find that there was actual harm in that the resident's condition deteriorated. When the resident was readmitted to the facility on December 8, 2001, with a decubitus pressure sore, the superficial wound measured .75 centimeters long by .5 centimeters wide. CMS Ex. 18, at 15. However, on December 12, 2001, although still superficial, the wound measured 3 centimeters long by 1.5 centimeters wide. CMS Ex. 18, at 10. Improvement and healing occurred after the State Agency reported the deficiency and the facility implemented repositioning measures every two hours and provided treatment to the pressure sore as directed by the physician. CMS Ex. 13, at 5.

b. State surveyor's findings for 42 C.F.R. � 483.25(c) as reflected at Tag F314 in the Statement of Deficiencies regarding Resident 121 (CMS Ex. 3, at 7, 8).

Review of the clinical record for R121 revealed medical diagnoses of dementia, hypertension, status post cerebral vascular accident, non-insulin dependent diabetes mellitus, and urinary retention. The resident was assessed as requiring extensive assistance from staff for all care. A review of the nursing assessment dated October 10, 2001, showed that R121 had intact heels and no pressure sores on admission to the facility. However, the October 17, 2001 pressure sore assessment disclosed that she was at high risk for developing pressure sores.

On November 1, 2001, the skin care documentation record revealed a Stage I pressure sore on the right heel. By December 10, 2001, the wound had progressed to a Stage III pressure ulcer.

The nursing care plan indicated that the resident was to have bilateral heel protectors while in bed and to have her heels elevated off the bed as much as possible. On December 10, 2001, the treating physician ordered the right heel to be covered with dry dressing after the application of protective ointment.

On December 11, 2001, at 8:02 a.m., the surveyor observed the right heel protector turned sideways and the right heel resting directly on the mattress. At 10:50 a.m., R121 was sitting in a wheelchair in the lounge with a slipper on the left foot and no sock or slipper on the right foot. The right heel, with the dressing, was resting directly on the carpet.

On December 12, 2001, at 8:23 a.m., the surveyor observed the resident lying in bed without bilateral heel protectors, and both heels resting directly on the mattress. At 10:16 a.m., the surveyor observed the resident without dressing on the right foot and the heel was resting directly on the floor. Two treatment nurses confirmed that the dressing was not on the heel and they were unaware how long it had been off.

Discussion

The gravamen of the deficiency regarding R121 is that the facility failed to provide her with bilateral heel protectors while in bed and to elevate the heels off the bed as much as possible, and to cover the pressure wound on the right heel with a dry dressing.

Petitioner argues that notwithstanding the physician's order it was not necessary to fit R121 with heel protectors because she was on a Select low air mattress. P. Br. at 10. I infer that if R121 developed pressure sores on her heels while lying on such a mattress, the physician deemed it appropriate not only to employ an additional pressure relieving device such as heel protectors, but also to maintain the heel elevated as much as possible. However, Petitioner chose to ignore the physician's directives, and allowed R121 to rest her heels in a manner already known to result in the development of pressure sores.

Petitioner further argues that had R121 not received appropriate skin care she would have developed "big decubes on her coccyx." P. Br. at 10. The argument is hollow because the facility is not charged with allowing R121 to develop pressure sores on her coccyx. In fact, the State Agency determined that the pressure sore acquired by R121 was unavoidable. The issue to consider is whether the facility provided R121 with necessary treatment and services to promote healing of the sore she acquired on her right heel, prevent infection and prevent new sores from developing. That issue is not addressed by arguing that she did not develop decubitus ulcers, but by showing how the facility complied with the instructions deemed by the treating physician to be necessary in order to promote healing of the wound to the right heel.

Petitioner's additional arguments, that R121's mobility in bed may have contributed to the heel protectors not being in place and that the surveyor's testimony that there appeared to be no medical reason for the debridement performed by Dr. Brown on the resident's heel on December 10, 2003, are also unfounded. It is unlikely that the absence of heel protectors on R121 during the survey could be attributed to her mobility in bed, inasmuch as the record reveals that the resident had suffered a spinal cord cerebral vascular accident and had lower extremity paralysis. CMS Ex. 12, at 12. Petitioner's reference to P. Ex. 8, at 35 and 124, and LPN Theresa Davis' testimony to show that the resident could move freely in bed amounts to an embellishment of her ability at locomotion. In fact, P. Ex. 8, at 35, reveals that R121 required extensive assistance (two or more persons) for turning and moving from side to side while in bed. Also, the fact that R121 moved around the facility in a wheelchair with staff assistance has no bearing on the failure to fit her with heel protectors at all times. Thus, there is no evidence that the instances when the surveyor observed R121 to be without heel protectors was attributable to her mobility. Moreover, assuming that R121 did cause the heel protectors to come off, that does not relieve the facility of the duty put them back on promptly and to consider ways to prevent them from falling off. Finally, the argument that the surveyor was incorrect in her opinion that debridement was unnecessary is not a matter pertinent to any issue before me.

c. State surveyor's findings for 42 C.F.R. � 483.25(c) as reflected at Tag F314 in the Statement of Deficiencies regarding Resident 101 (CMS Ex. 3, at 8-10).

R101 was diagnosed with dementia, insulin dependent diabetes, lung cancer, status post hip pinning, esophagitis, anemia, and osteoporosis. He required extensive two-person assistance for bed mobility. The resident was admitted on March 23, 2001, with a one centimeter red area with a one-half centimeter scabbed dry area on the bony prominence of the right outer ankle. At this time he was placed on an eggcrate mattress with bilateral heel protectors. Several pressure sore assessments identified him as a high risk for development of pressure sores. On November 1, 2001, the resident was observed with a .25 centimeter black area on the right ankle. The following day, the nurses notes revealed that the right ankle had a 0.5 centimeter raised area with a dark brown/black center. That same day, the physician ordered an antibiotic for 14 days due to the resident's swollen right ankle with purulent drainage. On November 16, 2001, the physician ordered a gel pad to the heel for under the right ankle.

On December 11, 2001, at 8:34 a.m., the surveyor and a facility nurse observed R101 with the right ankle resting directly on a pillow without the gel pad or the heel protectors. After care was given that morning, R101 was again observed at 9:29 a.m., with the ankle placed directly on the bed without the heel protectors or the gel pad.

On December 12, 2001, at 7:00 a.m., the surveyor observed R101 without the bilateral heel protectors as ordered. At 7:40 a.m., R101 was seen in bed with the pressure sore positioned directly on a piece of eggcrate which was placed on top of the gel pad. The pressure relieving devices were not placed so as to provide the necessary pressure relief to the bony prominence of the right ankle.

On December 14, 2001, at 7:25 a.m., the surveyor and two nurses measured the ankle wound and found that it had a scabbed yellow area that measured .25 centimeters, with a reddened area encompassing two centimeters by two centimeters.

Discussion

Petitioner contends that R101's condition underwent a change while he was out of the facility with his daughter. Specifically, asserts Petitioner, he had an accident while being transferred from the daughter's car. Additionally, the daughter allegedly ignored the physician's orders and treatments, and employed her own interventions. Finally, Petitioner maintains that, if R101's skin care was poor as indicated by CMS, R101 would have exhibited skin breakdown in other parts of his body. P. Br. at 6, 7. None of these arguments, however, addresses the issue of the facility's failure to apply the heel protectors and gel pad to promote healing and prevent new sores from developing.

Evidence regarding accidents that the resident may have experienced while in the care of his daughter outside the facility is irrelevant to the nursing home's duty to provide the care and treatment ordered by the treating physician. Equally irrelevant is the allegation that the daughter ignored the physician's orders and treatments. The orders and treatments at issue here were directed at the facility and not at R101's daughter. It was the duty of the facility to apply the heel protectors and the gel pad; and it was the facility that ignored the treating source directives. Moreover, the facility's Minimum Data Set coordinator, Ms. Linda Schaeper, testified that she never observed R101's daughter remove the gel pad or the heel protectors. Tr. at 304. In fact, there is no evidence in the record that establishes that R101's daughter interfered with the implementation of those interventions. Petitioner's other argument that the absence of pressure sores in other parts of R101's body is indicative of good skin care does not refute the evidence presented by CMS to show that the facility failed to follow the treating physician's orders to apply heel protectors and a gel pad to R101's heels and ankles.

3. The facility failed to serve food that was palatable and at the proper temperature.

a. State surveyor's findings for 42 C.F.R. � 483.35(d)(1), (2) as reflected at Tag F364 in the Statement of Deficiencies regarding Resident 101 (CMS Ex. 3, at 13, 14).

Based on observation, interviews, and policy review, the facility failed to serve palatable food on two days of the survey.

During a tour of the facility on December 10, 2001 at 9:05 a.m., two residents complained that the bacon and sausage were not warm. They did not want to eat it due to the food temperature. At 8:26 a.m., the sausage had been held in the kitchen steam table at 120 degrees Fahrenheit, whereas the facility policy stated that hot food would be delivered to residents at 140 degrees Fahrenheit or greater.

On December 12, 2001, the breakfast food was not served according to the facility policy. A test tray obtained at 7:35 a.m. revealed that the cart used for transportation of the meal was not heated. The cart left the kitchen at 7:45 a.m., and the first meal was served at 7:48 a.m. The last tray was served at 8:06 a.m. Test tray temperatures were taken by the administrative dietary staff using the facility thermometer. When the administrative dietary staff and the surveyor tested the food, they made the following findings:

�The pureed oatmeal was 115 degrees.

�The scrambled eggs were 100 to 102 degrees.

�The sausage biscuit/gravy was 110 degrees.

�The cooked sausage patty was 86 degrees.

�The cooked cereal tasted warm but not hot.

The facility policy stated that cold foods must be served less than or equal to 41 degrees Fahrenheit. The milk, however, was served at 50 degrees.

Six resident interviews, identified by the facility as a reliable source of information, complained of breakfast food as not being served hot.

Discussion

Petitioner contends that the surveyor only observed one tray on each of the two days that she looked into whether meals were being served at the appropriate temperature. Apparently, Petitioner does not consider that to be significant based on 840 meals served per day. Petitioner further argues that the citation was written in spite of the surveyor being made aware that, if the food was too cold, the facility microwaves it to raise the temperature, and that most of the residents interviewed had no concerns with food palatability. P. Br. at 3, 4.

The number of meals served by the facility on a daily basis is not relevant to the issue at hand. ⁽¹⁰⁾ Moreover, the regulations requires that each resident receive food that is palatable, attractive, and at the proper temperature. 42 C.F.R. � 483.35(d)(2). Thus, Petitioner's argument that most of the residents interviewed by the surveyor had no concerns with the food or its palatability is misplaced. P. Br. at 4. It is significant to note that the complaints of two residents on December 10, 2001, and the complaints of six residents on December 12, 2001, regarding food temperature, were determined to be substantiated based on the tests performed by the surveyor and facility staff. CMS Ex. 3, at 13, 14. Petitioner is not absolved because other residents did not or could not complain. CMS has established that food was held in a steam table that was only 120 degrees Fahrenheit and that the transportation cart was not heated. Consequently, not even the first residents to receive those meals were served what the facility policy considered to be hot meals, and the meals would logically become cooler for those at the end of the "serving line." The failure to provide hot meals is not resolved by heating meals in a microwave for those who protest, as suggested by Petitioner. In this regard, Ms. Stahl testified that microwaving would reduce palatability. Additionally, there is no reason why residents should have a delay in receiving their meals because they have to go back to be heated in a microwave oven, nor would all residents have the ability to request that their meals be heated.

In view of the foregoing, I find that CMS has established a prima facie case that Petitioner was not in compliance with the participation requirements under 42 C.F.R. � 483.35(d)(2). Petitioner has not overcome that showing by a preponderance of the evidence.

B. A basis exists to impose remedies against Petitioner for deficiencies that are at the less than immediate jeopardy level of noncompliance.

It has been clearly established that Petitioner failed to provide residents with the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well being, in accordance with the comprehensive assessment and care plan. Specifically, the facility failed to provide the necessary care for a resident with a suprapubic catheter, and residents having pressure sores did not receive necessary treatment and services to promote healing, prevent infection and prevent new sores from developing. Petitioner also failed to provide food that was palatable and at the proper temperature.

The record demonstrates that Petitioner was well aware of the risks associated with improper care of residents with a suprapubic catheter. Consistent with this knowledge, the facility developed a catheter care policy. CMS Ex. 31, at 10. However, the facility did not apply it in the case of R174. As a result, R174's stoma site developed a brown, purulent, foul smelling drainage that required physician intervention.

R107, R121, and R101 had pressure sores that were acquired prior to admission to the facility or after admission. Although the State Agency acknowledged that the sores were unavoidable, the facility had a duty to implement interventions to promote healing, prevent infection and prevent new sores from developing. More importantly, Petitioner did not follow the treating physician's orders regarding wound care for the residents in question nor did it advance cogent reasons for the failure to do so. Petitioner also failed to adhere to these residents' plans of care.

The evidence of record also shows that Petitioner failed to serve foods at the proper temperatures. Again, no acceptable reasons were advanced for this failure except that the affected residents were few in number and that the meals could be taken back to be heated in a microwave oven. These arguments do not relieve Petitioner of the duty to serve food to all residents at proper temperatures as well as food that is palatable.

In view of the foregoing, I conclude that CMS satisfied the criteria for imposing remedies at the less than immediate jeopardy level. First, CMS established a prima facie case, which Petitioner did not rebut, that as of December 14, 2001, it was not complying substantially with the participation requirements at 42 C.F.R. �� 483.25, 483.25(c), and 483.35(d)(1), (2). Second, Petitioner did not show it had eliminated the noncompliance on any date prior to January 30, 2002. Thus, I find that CMS may impose a CMP in the range of from $50 to $3,000 per day beginning December 14, 2001, and continuing through January 30, 2002. Petitioner completed its plan of correction on January 31, 2002, and on that same date the State survey agency found the facility to be in substantial compliance with participation requirements. CMS Ex. 13, at 13; CMS Ex. 1, at 8.

C. The amount of the penalty imposed by CMS is reasonable.

CMS imposed a $400 per day CMP for the period beginning December 14, 2001, and continuing through January 30, 2002. I sustain the penalty imposed. A penalty of $400 per day falls within a reasonable range of penalties which may be imposed for deficiencies that are at the less than the immediate jeopardy level of noncompliance, but constitute actual harm. 42 C.F.R. � 488.438(a)(ii). The beginning date of the penalty is the date that CMS first determined Petitioner not to be complying substantially with participation requirements. 42 C.F.R. � 488.440(a).

CMS argues that the reasonableness of the CMP imposed is supported by the following factors specified in 42 C.F.R. � 488.438(f):

�The facility's history of noncompliance.

�The facility's financial condition supports the reasonableness of the CMP.

�The seriousness of the deficiency and the facility's culpability support the reasonableness of the CMP.

Petitioner has not come forward with any evidence that, as a result of its financial condition, the payment of the CMP imposed would interfere with its operations.

V. Burden of Proof

Petitioner contends that by placing reliance on Hillman Rehabilitation Center, DAB No. 1611 (1997), aff'd, Hillman Rehabilitation Ctr, v. United States Department of Health and Human Services and Health Care Fin. Adm., No. 98-3789 (GEB), slip op. at 25 (D.N.J. May 13, 1999), I have imposed an erroneous burden of proof on the facility. However, Petitioner fails to advance support for its contention. Furthermore, the allocation of burden of proof is material only where the evidence is in equipoise, and the evidence in this case is not in equipoise. Fairfax Nursing Home, Inc. v. U.S. Dep't of Health and Human Services, 300 F.3d 835, 840, n.4 (7^th Cir. 2002), on appeal from Fairfax Nursing Home, Inc., DAB No. 1794 (2001), cert. denied 537 U.S. 1111 (2003).

VI. Conclusion

I conclude that CMS correctly determined that beginning December 14, 2001 through January 30, 2002, Petitioner was not complying with federal requirements governing participation of long-term care facilities in Medicare and State Medicaid programs at the less than immediate jeopardy level, and that the imposition of a CMP of $400 per day is reasonable.

José A. Anglada

Administrative Law Judge

1. The proffer of testimony concerns Dr. William Krall, Ms. Brenda Brown, Dr. Shane Gainey, and Dr. Joseph Yu.

2. Petitioner provided expert summaries for Linda Hogue, Linda Schaeper, Quanna Sheehan, and Lisa Ray.

3. I proceed under the assumption that the four witnesses mentioned in the post hearing proffer are experts, inasmuch as Petitioner does not so indicate.

4. Although I consider the matter totally irrelevant to the issues in this case, I should note that some of the cases cited by Petitioner were decided against CMS. I refer to the cases of Moran Manor, DAB CR824 (2001), and Homestead of Denison, DAB CR830 (2001). See list of cases attached to P. Br. None of the cases decided for CMS were reversed on appeal. It is also worthy of mention that the list includes a case decided by another judge, Western Care Management Corporation, DAB CR1020 (2003). Several of the cases cited involved dismissals based on jurisdictional grounds.

5. Page 42 of Petitioner's Ex. 5 is the medication administration record that purports to establish catheter care twice daily in accordance with facility policy. That same document, obtained during documentary exchange with Petitioner, was also submitted by CMS as Ex. 20, page 35. Ms. Berwanger, the surveyor, testified that it is customary for surveyors to place identifying numbers on the documents provided by the facility at the time of the survey. Inasmuch, those numbers were not noted on the document provided by Petitioner after litigation ensued, it was her belief that such document was not made available at a time contemporaneous with the survey.

6. The State Agency considered R107's pressure sore to be unavoidable because it was acquired outside the facility. Tr. at 102, 103.

7. Petitioner argues that the pressure sore observed by Ms. Cheatham during the survey healed by January 10, 2002. However, that was after the facility began to implement corrective action regarding its failure under Tag F314. P. Br. at 12; CMS Ex. 13, at 5.

8. The deficiency concerning the care given to R107 does not include the failure to provide heel protectors.

9. I agree with Petitioner that it was not necessary for Ms. Sheehan to examine every aide in the facility to determine whether R107 was repositioned on the mornings of December 11 and 12, 2001. To ascertain whether repositioning took place as required, all she had to do was query the nurse or nurses assigned to care for the resident on those dates.

10. It should be noted, however, that there are 210 residents in the facility and the survey only centered on the morning meal. Tr. at 251. No inquiry was made regarding the noon and evening meals.