SUBJECT:

Central Continuing Care,

Petitioner,

Centers for Medicare & Medicaid Services.

DECISION

I sustain the determination of the Centers for Medicare & Medicaid Services (CMS) to impose remedies against Petitioner, Central Continuing Care, consisting of civil money penalties of $400 for each day of a period that began on October 23, 2003, and which ran through November 10, 2003.

I. Background

Petitioner is a skilled nursing facility that is located in Mt. Airy, North Carolina. It participates in the Medicare program. Its participation in that program is governed by sections 1819 and 1866 of the Social Security Act (Act) and by implementing regulations at 42 C.F.R. Parts 483 and 488.

A survey ending on October 23, 2003 (October survey) was conducted to determine whether Petitioner was complying with Medicare participation requirements. The surveyors, employees of the North Carolina Department of Health and Human Services, determined that Petitioner was not complying substantially with certain requirements. Specifically, the surveyors found that Petitioner was not complying with participation requirements stated at 42 C.F.R. �� 483.10(n); 483.25; 483.25(c); and 483.35(h)(2). CMS accepted the surveyors' findings and determined to impose remedies consisting of civil money penalties of $400 for each day of Petitioner's noncompliance, beginning with October 23, 2003. It subsequently determined that Petitioner regained full compliance with participation requirements on November 11, 2003. The total period of Petitioner's noncompliance determined by CMS is 19 days, running from October 23 through November 10, 2003, and the total civil money penalties that CMS determined to impose are $7600.

Petitioner requested a hearing and the case was assigned to me for a hearing and a decision. In its hearing request, Petitioner challenged only one of the deficiency findings, the surveyors' finding that Petitioner had failed to comply substantially with the requirements of 42 C.F.R. � 483.25. I conducted a hearing in Greensboro, North Carolina, on January 6, 2005. At the hearing, I heard the cross-examination of several witnesses whose written direct testimony I received in exhibit form. I received 21 exhibits from CMS (CMS Ex. 1 - CMS Ex. 21) and 14 exhibits from Petitioner (CCC Ex. 1 - CCC Ex. 14) ⁽¹⁾.

II. Issues, findings of fact and conclusions of law

A. Issues

In this case Petitioner challenged only one of the four findings of noncompliance that were made at the October survey. The non-challenged findings are administratively final and may not be appealed further by Petitioner. Petitioner's challenge to one of the four noncompliance findings raises issues of whether:

1. Petitioner failed to comply substantially with the participation requirement that is stated at 42 C.F.R. � 483.25(c);

2. The period of Petitioner's noncompliance with participation requirements was from October 23, 2003 through November 10, 2003; and

3. Civil money penalties of $400 per day are reasonable as a remedy for Petitioner's noncompliance with participation requirements.

B. Findings of fact and conclusions of law

I make findings of fact and conclusions of law (Findings) to support my decision in this case. I set forth each Finding below as a separate heading. I discuss each Finding in detail.

1. Petitioner failed to comply substantially with the participation requirement that is stated at 42 C.F.R. � 483.25(c).

The regulation imposes two obligations on a participating facility. First, it requires the facility to assure that a resident who enters the facility without pressure sores not develop sores that are medically avoidable. 42 C.F.R. � 483.25(c)(1). Second, it requires the facility to assure that any resident who has pressure sores receives necessary treatment and services to promote healing, prevent infection, and prevent new sores from developing. 42 C.F.R. � 483.25(c)(2). CMS contends that Petitioner failed to comply with both of these requirements in providing care to a resident who is identified as Resident # 3 in the report of the October survey. CMS Ex. 1, at 9 - 18; CMS pre-hearing brief at 4 - 9; CMS post-hearing brief at 2 - 14.

Petitioner raises threshold issues of notice and due process. It contends that it only received notice from CMS that allegedly it failed to comply with the requirements of 42 C.F.R. � 483.25(c)(1). Petitioner argues that it is a denial of due process to require it to defend against allegations that it failed to comply with the requirements of 42 C.F.R. � 483.25(c)(2) in light of CMS's asserted failure to give it notice of any deficiency under this subsection.

I find no due process violation in holding Petitioner accountable under both subsections of the regulation. Petitioner clearly had notice, long before the January 6, 2005 hearing, that CMS intended to allege that Petitioner failed to comply with both of the regulation's requirements. And, it had ample opportunity prior to the hearing to respond to all of CMS's allegations.

Petitioner premises its argument on the wording of the allegations in the text of the report of the October survey. After paraphrasing the text of the entire regulation, i.e. 42 C.F.R. � 483.25(c)(1) and (2), the report states that:

Based on observations, staff interviews, and record reviews, the facility failed to provide care, treatment, and services to prevent a pressure sore for 1 resident (#3) of 4 residents reviewed with pressure sores.

CMS Ex. 1, at 9. According to Petitioner, this language limits CMS's assertions of noncompliance only to the assertion that Petitioner failed to prevent Resident # 3 from developing an avoidable sore.

One would have to read the quoted statement in a vacuum to conclude that the surveyors found only that Petitioner failed to prevent the development of an avoidable sore and made no findings as to how Petitioner's staff treated a sore after it developed. Such a reading would ignore the several pages of allegations made by the surveyors which address both alleged failures by Petitioner to prevent the resident from developing a pressure sore and to treat a sore that the resident had developed. E.g., CMS Ex. 1, at 14 - 18. A narrow reading of the allegation would also ignore the fact that CMS has consistently asserted broader allegations of noncompliance that focus on both of the regulation's requirements and not just on the requirement that a facility prevent the development of an avoidable sore. Thus, in its pre-hearing brief, filed on May 26, 2004, six months prior to the hearing, CMS addressed in detail its allegations that Petitioner failed, not only to prevent the development of an avoidable sore, but to treat adequately a sore after it developed.

These assertions, both in the survey report and in CMS's subsequent filings, gave Petitioner ample notice of what is at issue here. Furthermore, I provided Petitioner with a generous amount of time to prepare its defenses to these allegations. The pre-hearing order that I issued in this case directed CMS to file both its pre-hearing brief and supporting evidence a full month before Petitioner had to submit its brief and evidence.

Turning to the merits, I find that CMS established a prima facie case, which Petitioner did not rebut, proving that Petitioner failed both adequately to prevent the development of an avoidable pressure sore and to provide treatment for that sore after it developed. The essential elements of CMS's case are as follows:

� Resident # 3 was diagnosed to be suffering from a number of medical conditions: hyperlipidemia; non-psychotic brain syndrome; organic brain syndrome; hypertension; convulsions; feeding problems; and esophageal reflux. CMS Ex. 1, at 12. Resident # 3's quarterly minimum data set dated June 18, 2003, indicated that the resident was totally dependent on the staff to provide all of his activities of daily living, including turning, repositioning, and incontinent care. It also indicated that Resident # 3 was not experiencing any pressure sores although he was assessed to be at a relatively high risk for developing them. Id.

� On June 29, 2003, Petitioner's staff observed a broken skin area on Resident # 3's coccyx. CMS Ex. 1, at 12. The staff documented the presence of a pressure sore in the area of the resident's coccyx on numerous occasions during the ensuing period of approximately four months prior to the October survey. Id. at 12 - 14. During this period, the resident's pressure sore persisted or worsened. CMS Ex. 14, at 2.

� There was nothing in Resident # 3's record to suggest that his pressure sore was the unavoidable consequence of the resident's various afflictions. CMS Ex. 16, at 2.

� Petitioner's care plan for Resident # 3 required that the resident be repositioned every two hours. CMS Ex. 16, at 3. Petitioner maintained no charts or other records that documented that the resident was repositioned. Id.

� During the period from June 29 until the October survey, the treatment regime for the resident's pressure sore was changed only infrequently notwithstanding the sore's persistence. CMS Ex. 14, at 2. On September 9, 2003, physical therapy recommended that the resident receive support devices. Id. On October 1, 2003, a physician ordered that a Duoderm dressing was to be administered to the resident's coccyx once every three days until the sore healed. CMS Ex. 1, at 14. Additionally, orders were issued that the resident receive: a lateral support to prevent him from leaning while seated in a geri-chair; an abductor wedge to be used while the resident was in bed and while seated in a geri-chair to deal with the resident's knee contractions; and, a gel cushion to be used to provide protection while the resident was seated in the geri-chair. Id.

� During the approximately four months that Resident # 3 manifested a pressure sore, Petitioner's staff failed to measure the depth of the sore. CMS Ex. 16, at 3. The staff only measured the height and width of the sore. It is important to measure the depth of a pressure sore in order to determine its seriousness and the appropriate treatment regimen. Id. at 3 - 4.

� On October 22, 2003, at 6:30 a.m., the surveyors observed the Duoderm dressing on the resident's coccyx to be partially detached and contaminated with fecal matter and urine. CMS Ex. 1, at 14 - 15; CMS Ex. 16, at 4. However, Petitioner's nursing assistants and floor nurse did not replace the dressing, contending that only Petitioner's wound nurse was trained to do so. Ids. As a consequence, the contaminated dressing was left on the resident's wound. CMS Ex. 1, at 15. At 12:50 p.m. on October 22, 2003, more than six hours after the initial observation, the resident was observed to be still wearing the contaminated Duoderm. Id.

� Resident # 3 was observed on October 21 and 22, 2003, to be seated in a geri-chair without a protective gel cushion and without positioning devices, notwithstanding his physician's order that he receive these devices. CMS Ex. 1, at 14-15.

� On October 22, 2003, the resident was observed to be in bed without the positioning devices that had been ordered by the resident's physician. CMS Ex. 1, at 14.

� The surveyors observed Resident # 3 continuously from about 6:30 a.m. to about 10:05 a.m. on October 22, 2003. During this time period, the resident's position was never changed notwithstanding the requirement in the resident's care plan that he be repositioned every two hours. CMS Ex. 1, at 15; CMS Ex. 16, at 3.

The foregoing evidence, if unrebutted by Petitioner, shows Petitioner to be derelict in providing care to Resident # 3, either to prevent the resident from developing pressure sores, or to treat a sore after it developed. The inference that I draw from the records and surveyor observations that CMS introduced is that Petitioner's care of Resident # 3 was haphazard at best. Petitioner's staff simply failed to give the resident that which he needed to protect him against developing a pressure sore or to heal the one that did develop. The evidence shows that the sore was avoidable. Resident # 3 had no medical condition that made the development of a pressure sore inevitable. The risk to the resident lay in the fact that he was essentially helpless and depended on Petitioner's staff to protect him against being in any position for so long as to damage the resident's skin. But, it is evident from the evidence offered by CMS that the staff failed to do that. Once the resident developed a sore, it was incumbent on Petitioner to be rigorous in its efforts to promote healing, prevent infection, and prevent additional sores from developing. But, rigor is hardly the word to describe what was being done for Resident # 3, based on the evidence offered by CMS. To the contrary, the evidence shows that Petitioner's staff essentially disregarded the resident's physician's treatment orders.

Petitioner argues that Resident # 3's pressure sore was unavoidable and the inevitable consequence of the resident's medical condition. See 42 C.F.R. � 483.25(c)(1). As support for this argument, Petitioner introduced the statements of a physician and a podiatrist. CCC Ex. 3; CCC Ex. 1. In his statement, Dr. Catalin Burciu, Petitioner's attending physician, asserts that Resident # 3 suffered from multiple medical conditions. CCC Ex. 3. He avers that the resident developed a pressure sore "in spite of receiving good optimal care . . . ." Id. He concludes that the resident's sore is "an unfortunate and unavoidable result of his advanced terminal condition." Id. Dr. Robin M. France, D.P.M., a podiatrist, asserts that Resident # 3 suffered from peripheral vascular disease which was partly responsible for the resident developing superficial ulcerations to his left foot. CCC Ex. 1.

These statements, neither singly nor in combination, are persuasive proof that Resident # 3's pressure sore was unavoidable. They certainly support a conclusion that the resident was at high risk for developing sores. But the fact that the resident was at high risk for developing pressure sores does not mean that his development of a sore was inevitable.

CMS disputes Petitioner's contention that Resident # 3 suffered from an "advanced terminal condition." I find the parties' dispute as to whether the resident was terminally ill to be largely besides the point. Petitioner cannot claim legitimately that the resident developed an unavoidable pressure sore absent proving that it undertook all reasonable measures - including those which were included in the resident's plan of care - to protect the resident against developing a sore. Its failure to prove that it did so renders largely irrelevant the argument about the extent of the resident's illness.

I might conclude that the resident's sore was unavoidable if the record supported Dr. Burciu's contention that the resident received "good optimal care" from Petitioner's staff. But, the record fails to support that. There is nothing in the record of this case to support a conclusion that Petitioner's staff worked diligently to protect Resident # 3 in the face of the resident's high risk for developing pressure sores. Petitioner offered no credible documentation, for example, showing that Resident # 3 was repositioned according to any schedule established by the resident's plan of care.

One of the exhibits offered by Petitioner is a document that is titled "Daily Care Record." CCC Ex. 4. In some respects, the exhibit is illegible. But, those parts of the exhibit that are legible do not support a conclusion that Petitioner was diligent in providing daily care to Resident # 3.

In the lower right hand corner under the heading of "Month/Year" is the entry "10-03" suggesting that this document is a record for October 2003. CCC Ex. 4. Across the top of the form are dates numbered 1 - 16. I infer that this document is a daily care record covering the month of October 2003. In the left hand margin of the form is a heading entitled "POSITION Changed q 2hrs N/A Frequency:". This appears to label a horizontal column in which someone could document when the resident was repositioned. Each date contains entries in the "D" column, written vertically, in the same hand, consisting almost entirely of the numbers "7, 9, 11, 1".

I do not find this document to be persuasive evidence to show that Petitioner's staff repositioned the resident diligently consistent with the resident's plan of care. First, the document covers only the month of October, 2003. It says nothing about the four previous months. Second, the entries in the document seem only to cover a 6-hour period in a 24-hour day. Thus, even if Petitioner's staff repositioned the resident every two hours during the period from 7 a.m. to 1 p.m., the exhibit says nothing about the remainder of the day. Finally, the entries - being made in identical handwriting and showing repositioning being done at the exact same times of each day - are not, in and of themselves, very credible evidence that the resident actually was repositioned on the dates and times indicated in the chart. I am not persuaded from these entries that the resident would be repositioned at the precise same times every day for a month. ⁽²⁾

Indeed, the observations of the surveyors support the conclusion that repositioning of the resident was haphazard at best. ⁽³⁾ I find these observations to be far more persuasive than the chart supplied by Petitioner.

Petitioner offered no persuasive evidence to prove that it provided Resident # 3 with the care necessary to promote healing of his pressure sore, prevent infection, and to prevent new sores from developing. See 42 C.F.R. � 483.25(c)(2). As Petitioner makes clear in its post-hearing brief, it has opted not to challenge CMS's evidence as to its noncompliance with 42 C.F.R. � 483.25(c)(2). Rather, Petitioner rests on its assertion that it should not have to defend against CMS's allegations on the ground that it did not receive reasonable notice of them. I have discussed this argument above and I find it to be without merit. Moreover, as I discuss above, the evidence that Petitioner did offer concerning the care that it gave to Resident # 3 is not persuasive evidence that Petitioner's staff followed the care plan established for the resident. Consequently, CMS's prima facie case that Petitioner failed to provide care that met the requirements of 42 C.F.R. � 483.25(c)(2) stands unrebutted by Petitioner.

2. The period of Petitioner's noncompliance with participation requirements was from October 23, 2003 through November 10, 2003.

Petitioner challenges CMS's determination as to the duration of Petitioner's noncompliance. It contends that, if it was not complying with participation requirements, it regained compliance no later than October 23, 2003, the same date that it was found to be out of compliance with participation requirements. Thus, according to Petitioner, it should be liable for only one day's noncompliance assuming that any noncompliance is established. As proof of this contention, Petitioner relies on the plan of correction that it submitted to the North Carolina Department of Health and Human Services in which it asserted that it would attain compliance with the requirements of 42 C.F.R. � 483.25(c) by no later than October 23, 2003. See CMS Ex. 1, at 10 - 11.

I am not persuaded by Petitioner's arguments or its evidence. The evidence establishing Petitioner's noncompliance as of October 23, 2003, creates a presumption of continuing noncompliance. Petitioner may overcome that by proving, by the preponderance of the evidence, that it attained compliance at a date that is earlier than the date of compliance determined by CMS. But, that is Petitioner's burden to prove.

The fact that Petitioner asserted in its plan of correction that it attained compliance as of October 23, 2003 is not sufficient, in my judgment, to overcome the presumption of continued noncompliance. Petitioner offered no corroborating evidence to establish that it implemented all necessary corrective actions prior to November 11, 2003. See CCC Ex. 8. Indeed, Petitioner did not even claim in its plan of correction that it would attain full compliance with all participation requirements prior to November 11, 2003. There are deficiencies cited by CMS that Petitioner did not challenge. In its plan of correction addressing two of those unchallenged deficiencies, Petitioner averred that it would attain compliance on November 10 and 11, 2003, respectively. CMS Ex. 1, at 2, 5.

3. Civil money penalties of $400 per day are reasonable as a remedy for Petitioner's noncompliance with participation requirements.

Regulations establish the criteria for deciding whether a civil money penalty amount is reasonable. 42 C.F.R. �� 488.438(f)(1) - (4); 488.404 (incorporated by reference into 42 C.F.R. � 488.438(f)(3)). These factors include: the seriousness of a facility's noncompliance; its compliance history; its culpability; and its ability to pay the penalties that are imposed. In this case, CMS asserts that the penalties of $400 per day that it determined to impose are justified based on the seriousness of Petitioner's noncompliance. I find this argument to be persuasive.

Petitioner's noncompliance with the two subsections of 42 C.F.R � 483.25(c) was serious. A resident suffered injury as a consequence of Petitioner's failure to prevent the resident from developing an avoidable pressure sore. The resident's injury was exacerbated by Petitioner's failure to systematically take measures to promote healing, protect the resident from acquiring an infection, and protect the resident from developing new sores. Among other things, the haphazard care which Petitioner's staff gave to Resident # 3 exposed the resident to contamination from feces, thereby increasing his risk of developing an infection.

Moreover, it is reasonable to infer that Petitioner's deficient care of Resident # 3 was a manifestation of a systemic problem and not isolated. I find to be revealing the response of Petitioner's staff when, at 6:30 a.m. on October 22, 2003, a surveyor brought to the staff's attention the fact that the resident was wearing a Duoderm dressing that was contaminated with feces. The staff's reaction was to acknowledge that this was a problem but to assert that the resident would have to wait until 8:00 a.m. for the wound nurse to come on duty. And, at 12:50 p.m. on that date, more than six hours later, the resident was observed by the surveyor still to be wearing the contaminated Duoderm. CMS Ex. 1, at 14 - 15. This indifferent response by Petitioner's staff to an obvious and urgent problem is proof, in my judgment, that the staff was insensitive - not just to the needs of Resident # 3 - but to the broad requirement that it be diligent in protecting residents from infection.

A $400 per day civil money penalty is, therefore, reasonable in light of the seriousness of Petitioner's noncompliance. The penalty amount is actually quite modest given that the maximum amount that CMS is authorized to impose for deficiencies that do not fall into the immediate jeopardy category of deficiencies is $3,000 per day. 42 C.F.R. � 488.438(a)(1)(ii). Petitioner did not present any evidence addressing the regulatory factors that govern the civil money penalty amount that would justify reduction of the penalties.

Petitioner's failure to comply with the requirements of 42 C.F.R. � 483.25(c)(1) and (2) was not its only deficiency during the October 23 - November 10, 2003 period. As I discuss in the introduction to this decision, Petitioner failed to comply substantially with three other participation requirements. Its failure to comply with any one of these requirements supports imposition of civil money penalties of at least $50 per day. Moreover, Petitioner's noncompliance with 42 C.F.R. � 483.35(h)(2), a regulation that requires a facility to store, prepare, distribute and serve food under sanitary conditions, was found by the surveyors to be relatively serious. CMS Ex. 1, at 18 - 24. Arguably, that deficiency, in and of itself, might support penalties of as much as $400 per day. The presence of that deficiency and two other unchallenged deficiencies thus supports the $400 per day civil money penalties that I have found to be justified in this case.

Steven T. Kessel

Administrative Law Judge

1. The exhibits that I received from CMS include an amended CMS Ex. 13. CMS moved, prior to the hearing, to amend its submission. I grant that motion.

2. The testimony offered by Petitioner concerning this exhibit added nothing to the record that would make the exhibit more persuasive. Ms. Shasta Culler, a nurse, admitted that it would be impossible for Petitioner's staff to reposition the resident at exactly the same time each day. Tr. at 81. She admitted additionally that the entries on the exhibit may not accurately indicate when the resident was repositioned. Id. at 82.

3. The surveyors' observations of the staff's failure to reposition the resident and to provide the resident with protective devices were made in October 2003. It is not unreasonable for me to infer that the failures that were observed in October typified the care that the staff gave to the resident in previous months given the failure of Petitioner's staff to document that they were complying with the resident's plan of care.