SUBJECT:

Tara at Thunderbolt,

Petitioner,

Centers for Medicare & Medicaid Services.

DECISION

I sustain the imposition of civil money penalties against Petitioner, Tara at Thunderbolt Nursing & Rehabilitation, in amounts of $3,050 per day for a period that began on March 24, 2005 and continued through March 26, 2005.

I do not sustain the imposition of additional civil money penalties against Petitioner for dates after March 26, 2005. I am remanding this case back to CMS for a determination of what, if any, civil money penalties would be appropriate for dates after March 26, 2005, in amounts that would be reasonable to remedy deficiencies that are not at the immediate jeopardy level.

I. Background

Petitioner is a skilled nursing facility located in Savannah, Georgia. Petitioner participates in the Medicare program. Its participation in Medicare is subject to sections 1819 and 1866 of the Social Security Act and to regulations at 42 C.F.R. Parts 483 and 488.

Petitioner was surveyed for compliance with Medicare participation requirements in a survey that was completed on March 24, 2005 (March survey). The surveyors found several deficiencies. They found some of the deficiencies to be so egregious as to comprise immediate jeopardy for residents of the facility. They found that Petitioner did not correct its deficiencies until April 11, 2005.

The Centers for Medicare & Medicaid Services (CMS) concurred with the surveyors' findings. It imposed remedies against Petitioner consisting of civil money penalties in the amounts of $5,000 per day, for each day of the period that began on March 24, 2005 and which ran through April 11, 2005. The amount of civil money penalties that CMS determined to impose is $90,000.

Petitioner requested a hearing and the case was assigned to me for a hearing and a decision. I issued an initial pre-hearing order pursuant to which the parties filed pre-hearing exchanges and briefs. I scheduled the case for a hearing in Savannah, Georgia. Prior to the hearing, the parties advised me that they had agreed to have the case heard based on their written submissions. I then issued an order establishing a schedule for the parties to file briefs addressing all legal and fact issues in the case and, additionally, providing the parties the opportunity to file reply briefs. Order Establishing Briefing Schedule and Issuing Directions for Content of Briefs, February 27, 2006. Each party filed a brief. Neither party filed a reply brief.

CMS submitted 50 proposed exhibits (CMS Exhibit (Ex.) 1 - CMS Ex. 50). Additionally, it submitted declarations of several witnesses: Christy Glymph; Deborah W. Herring; Eugenia Johnston; Kathy New; and Kaye Poss. Counsel for CMS did not identify these declarations with exhibit numbers. For purposes of creating a record, I am identifying the declarations as follows: declaration of Christy Glymph, CMS Ex. 51; declaration of Deborah W. Herring, CMS Ex. 52; declaration of Eugenia Johnston, CMS Ex. 53; declaration of Kathy New, CMS Ex. 54; and declaration of Kaye Poss, CMS Ex. 55. Petitioner submitted 60 proposed exhibits (P. Ex. 1 - P. Ex. 60). Neither party filed objections to my receiving into evidence any of the proposed exhibits. Consequently, I receive into evidence CMS Ex. 1 - CMS Ex. 55, and P. Ex. 1 - P. Ex. 60.

II. Issues, findings of fact and conclusions of law

A. Issues

In this decision I decide only the issues that the parties raised in their respective briefs. I made it explicit in my initial pre-hearing order and in my February 27, 2006 order that I expected the parties to brief in detail any issue that they wished me to hear and decide. I would not decide issues that were not raised by the parties. There are potential issues which the parties might have argued, but which they did not, which I am excluding from this decision. For example, the report of the March survey cited a total of 16 alleged failures by Petitioner to comply with Medicare regulations. CMS Ex. 48. However, in its briefs CMS addressed only eight of these alleged deficiencies. I decide only the eight deficiencies that CMS specifically addressed. ⁽¹⁾ I conclude that CMS abandoned its allegations concerning the additional eight deficiencies because it did not address them in its briefs.

The issues that I hear and decide in this case are the following:

1. Do I have the authority to hear and decide Petitioner's arguments that the survey process and the method by which remedies are determined violates federal constitutional requirements and/or various statutes?

2. Did Petitioner fail to comply substantially with one or more Medicare participation requirements?

3. Was CMS's determination that Petitioner's noncompliance comprised immediate jeopardy for Petitioner's residents clearly erroneous?

4. What is the duration of Petitioner's noncompliance?

5. What civil money penalty amount is reasonable?

6. Is an order of remand appropriate to address issues that I am unable to decide at this time?

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.

1. I do not have authority to hear and decide Petitioner's constitutional arguments or its assertions that CMS's processes violate federal law.

Petitioner makes various arguments attacking the constitutionality of CMS's Medicare regulations and regulation enforcement process and/or contending that aspects of the process violate various statutes. Petitioner's brief at 52 - 56. I do not have authority to hear and decide these arguments. My authority to hear and decide cases involving CMS is defined by regulations and by the delegations of the Secretary of the United States Department of Health and Human Services. Regulations do not confer any authority on administrative law judges to hear and decide constitutional questions or to decide whether CMS's processes are unlawful. See 42 C.F.R. �� 498.3, 498.5. Nor am I aware of any Secretarial delegations which confer such authority.

2. Petitioner failed to comply substantially with Medicare participation requirements.

The allegations of noncompliance in this case relate more or less entirely to the alleged failure by Petitioner to provide appropriate and necessary care to prevent and treat residents' pressure sores and other skin wounds. These allegations focus on Petitioner's alleged failures: to assess residents for the presence of pressure sores and for their vulnerability to developing sores; and, to provide scheduled preventive and wound care.

I discuss CMS's allegations and my conclusions about them in detail, below, at parts a. - h. of this Finding. As a general conclusion, however, I find that CMS's assertions are strongly supported by the evidence. The evidence establishes that for a period of at least several weeks prior to the March survey Petitioner's staff failed to pay close attention to the skin care problems of many of its residents. The overall picture created by this evidence is of a facility that provided slipshod care at best. Residents who were supposed to be assessed for skin problems were not assessed. Necessary care was poorly documented and, in at least some instances, not provided to residents.

a. Petitioner failed to comply substantially with the requirements of 42 C.F.R. � 483.25(a).

The regulation at issue states that a facility must, based on its comprehensive assessment of a resident's condition, ensure that a resident who enters a facility without pressure sores does not develop one unless the resident's clinical condition establishes that the development of a sore or sores was clinically unavoidable. The regulation also provides that a facility must ensure that any resident who has a pressure sore receives treatment and services that are necessary to promote healing, prevent infection, and prevent new sores from developing. 42 C.F.R. � 483.25(a).

CMS's allegations of noncompliance center around the care that Petitioner gave to nine of its residents, identified in the report of the March survey as Residents #s 1, 3, 4, 7, 16, 17, 26, and 27, and Resident B. CMS Ex. 48, at 28 - 41. CMS asserts that Petitioner failed to provide these residents with necessary treatment in order to prevent the development of sores or in order to promote healing of sores.

The weight of the evidence strongly supports CMS's contentions about the care that Petitioner gave to the nine residents in question. For the most part Petitioner failed directly to rebut the evidence of its noncompliance. My conclusion, based on the evidence relating to the care that these residents received, is that Petitioner manifested a general failure to provide necessary preventive care and treatment to its residents who were at risk for developing, or who had developed, pressure sores.

i. Resident B

Resident B was an individual who was admitted to Petitioner's facility in September 2004 suffering from peripheral vascular disease related to diabetes. The resident's disease had progressed to the point where amputations had been performed on both of the resident's lower extremities. Between November 2004 and March 2005, the resident's condition deteriorated substantially. Beginning in December 2004, the resident developed sores on his right leg which became gangrenous over time. In February 2005, the resident's condition deteriorated to the point that he was hospitalized for a revision of the amputation of his right leg. CMS Ex. 48, at 28 - 30.

CMS identified specific failures by Petitioner to provide care to Resident B. The most significant of these are the following:

� A physician ordered that weekly assessments be made of the resident's skin. However, the resident's treatment records fail to document that these assessments were made. CMS Ex. 48, at 29, 31.

� In late December, the resident's physician ordered that hydrocolloid dressings be applied daily to Resident B's posterior right thigh as treatment for the sores that had developed there. However, on two occasions in January 2005 the resident's record does not show that dressings were changed. CMS Ex. 48, at 29.

� On January 11, 2005, a nurse noted that the resident had multiple areas on his right posterior thigh. No measurements were recorded of these sores. CMS Ex. 48, at 29.

� On January 24, 2005, a nurse noticed that the resident's wounds emitted a foul odor. The nurse attempted, unsuccessfully, to contact the resident's physician. However, no persistent attempts were made to establish contact and the physician was not finally contacted until January 27, 2005. CMS Ex. 48, at 31.

� On two occasions in January 2005 the resident refused treatment. No attempt was made to advise the resident's physician of these refusals. CMS Ex. 48, at 31.

Petitioner offered no evidence that refutes specifically the allegations made by CMS. Instead, Petitioner counters CMS's specific allegations with the generalized assertion that its staff closely followed Resident B's condition and was attentive to the resident's needs. Petitioner's brief at 14. ⁽²⁾ I find this generalized assertion not to be persuasive, particularly in light of the very specific nature of CMS's allegations.

Petitioner also contends, in effect, that many of CMS's allegations are simply irrelevant. It argues that the sores manifested by Resident B were "stasis ulcers" caused by venous insufficiency and not pressure sores. Consequently, according to Petitioner, any failures by Petitioner to prevent these sores from occurring or to treat them once they occurred are not germane because the regulation at issue doesn't apply to stasis ulcers.

I disagree with this contention. The regulation broadly requires a facility to take steps that are necessary to prevent and to treat pressure sores. The issue before me is not whether sores that were not treated correctly actually were pressure sores. Rather, it is whether the facility did all that it was supposed to do to deal with the possibility that a resident's sores were caused by pressure. That standard clearly was not met by Petitioner.

Petitioner also argues that Resident B's sores were the inevitable consequence of a disease process and that Petitioner could not have done anything to prevent these sores from developing or worsening. I find this argument to be unpersuasive. The regulation does not excuse a facility from providing prescribed and appropriate care. Here, a physician ordered that the resident's skin be assessed weekly and that certain treatments be provided. Petitioner failed to carry out these orders. I find that its derelictions cannot be excused by saying that, with the benefit of hindsight, the treatments and assessments ordered but not provided would have been useless anyway.

Finally, Petitioner argues here, as it does elsewhere in its brief that the fact that its staff did not document care does not mean necessarily that the undocumented care was not provided. In effect, Petitioner asserts that I should not infer that it failed to provide care simply because care was not documented. I find this argument to be unpersuasive here and elsewhere. A facility is supposed to document the care that it provides to residents. That is part of its obligations to its residents. Failure to document care raises at least an inference that the undocumented care was not provided. A facility might rebut that inference by proving, with documents or testimony, that the undocumented care actually was provided as ordered. But, Petitioner did neither here.

ii. Resident # 17

This resident was admitted to Petitioner's facility on February 28, 2005. On admission the resident was noted to have a partially filled blister on one heel and a discolored area on the other heel. CMS Ex. 48, at 32. It was ordered that the resident wear air boots while in bed in order to protect the resident's heels. Id. However, on March 22, 2005, a surveyor observed the resident lying in bed without air boots.

Petitioner offers no direct response to CMS's allegation. Instead, it argues that the sores on the resident's heels were stasis ulcers, thereby excusing Petitioner from liability under the pressure sore regulation. Petitioner's brief at 11.

I find this argument to be without merit. Here, the resident was ordered to wear air boots as protection against worsening sores but also as a preventive device. Petitioner's obligation under 42 C.F.R. � 483.25(a) was to take all reasonable necessary preventive measures to protect Resident # 17 from developing sores. It failed to do that.

iii. Resident # 1

Petitioner's staff reported on February 9, 2005 that the resident had a Stage II pressure sore. CMS Ex. 48, at 33. The resident was ordered at first to be treated with a hydrocolloid dressing. Subsequently, the treatment was ordered to be changed to daily application of Dermagen. Id. The resident's treatment record does not show that the hydrocolloid dressing was applied on either March 4 or 6, 2005. It does not show that Dermagen was applied on March 15, 16, 18, 19, or 20.

The inference that I draw from this evidence is that Petitioner's staff failed to provide prescribed care to the resident on any of the cited dates. Petitioner has offered nothing to rebut this evidence, arguing only that the resident's sore was a Stage II sore that did not support a finding of an immediate jeopardy level deficiency. ⁽³⁾

iv. Resident # 16

This resident had a history of pressure sores. CMS Ex. 48, at 33 - 34. On March 22, 2005, the resident was observed to have developed two new Stage II pressure sores. The surveyor interviewed Petitioner's charge nurse who, incorrectly, thought that the resident had only a Stage I sore. Id.

The evidence cited by CMS is a basis to infer that Petitioner's staff was not attentive to Resident # 16's skin condition. Petitioner did not rebut this evidence at all, except to argue that the resident's Stage II sores could not be a basis for a finding of an immediate jeopardy level deficiency. Petitioner's brief at 8 - 9.

v. Resident # 27

This resident's plan of care found the resident to be at risk for skin problems. CMS Ex. 48, at 34. One of the treatment approaches provided by the plan was that the resident be provided with pressure relieving devices. Id. However, on March 23, 2005, a surveyor observed the resident to be seated in a wheelchair without a pressure relieving device. Id. Additionally, the resident was to receive treatments for pressure sores every other day. There was no documentation that the resident received such treatments on either March 8, or March 10, 2005. Id.

The evidence offered by CMS establishes prima facie that Petitioner was not providing Resident # 27 with prescribed care to prevent or treat pressure sores. Petitioner does not deny this evidence, arguing only that the resident's sores were not so bad as to support a finding of an immediate jeopardy level deficiency. Petitioner's brief at 8 - 9.

vi. Resident # 3

Petitioner's staff observed a pressure sore on the resident's right buttocks. CMS Ex. 48, at 34. The staff was ordered to apply a hydrocolloid dressing to the sore daily. In February 2005, the staff failed to document providing three of seven prescribed treatments. In March, the staff failed to document providing five of eleven prescribed treatments. Id. Additionally, the resident was supposed to be supplied with a pressure relieving cushion. However, on March 21, 2005, the resident was observed by a surveyor to be sitting on a non-pressure relieving cushion. Id. at 35.

From this evidence, I infer that Petitioner failed to supply Resident # 3 with prescribed treatments for the resident's pressure sore. Petitioner did not offer any evidence to rebut the evidence offered by CMS, arguing only that the harm caused by the failure to provide prescribed care to Resident # 3 did not rise to the level of immediate jeopardy. Petitioner's brief at 8 - 9.

vii. Resident # 7

Petitioner's staff assessed this resident as having multiple pressure sores. CMS Ex. 48, at 35 - 36. Additionally, the resident was determined by Petitioner's staff to exhibit low protein and albumin levels, a possibly nutrition-related problem that could contribute to the development, worsening, or failure to heal, pressure sores. Id. at 36. However, the staff failed to obtain an order from the resident's physician for vitamin or protein supplements. Moreover, Petitioner's dietician advised the surveyors who conducted the March survey that she was unaware that the resident had a protein and albumin deficiency. Id. at 37. In addition, treatments that were ordered for the resident's pressure sores were not documented as having been performed on 11 occasions in February 2005 and on 12 occasions in March. Id. at 36.

The foregoing evidence supports a conclusion that Petitioner's staff neglected to provide required care to treat Resident # 7's pressure sores. Petitioner offered no evidence to contradict what CMS offered. For example, it provided no proof that undocumented care actually was provided to the resident. Nor did it directly refute the dietician's admission that she was unaware of the resident's protein and albumin problems. Petitioner's only argument is that, whatever its shortcomings may have been, they did not rise to the level of immediate jeopardy. Petitioner's brief at 8 - 9.

viii. Resident # 4

This resident was admitted to Petitioner's facility from a hospital on January 5, 2005. CMS Ex. 48, at 37. As of the resident's admission the resident had Stage III pressure sores on both heels and several Stage I sores elsewhere. The resident's physician ordered that the sores be treated. However, ordered care is not documented in numerous instances. In January 2005, on two instances care was not documented as having been provided to the resident's left heel. Id. at 38. There was no documentation that any wound care was provided to the resident during Petitioner's 3 p.m. - 11 p.m. shift during the month of January. There were four failures in January to document wound care to the resident's sacrum and 11 failures in that month to document wound care to the resident's right heel. Id. In February, there were 17 failures to document wound care to the resident's lower extremities and 10 failures to document care to the resident's sacrum. Id.

On March 14, 2005, a new pressure sore was observed on the resident's left foot. CMS Ex. 48, at 39. However, no orders for wound care for this sore were recorded in the resident's records. Finally, in March, there were 5 failures to document wound care for the resident. Id. at 40.

The foregoing evidence provides strong prima facie proof that the resident did not receive requisite pressure sore and wound care. I infer from the failure to document care that prescribed care was not provided to Resident # 4 in January, February, and March 2005. Petitioner offered no evidence to show that the care was, in fact, provided. It offered no records that would explain the gaps in the resident's care documentation. Nor did it offer testimony from any individual in which that individual affirmed that he or she actually provided the care despite failing to document it.

ix. Resident # 26

This resident was observed to have pressure sores to both buttocks. CMS Ex. 48, at 40. Care was prescribed for the resident. However, documentation that the care was actually given to the resident is lacking for two occasions in March 2005. Id.

I infer from the absence of documentation that the resident failed to receive the prescribed care. Petitioner offered nothing to prove that the care actually was provided. See Petitioner's brief at 8 - 9.

Petitioner argues that, even if the care it gave to the nine residents whose care is at issue was deficient, the care that it gave to nine other residents whose records were reviewed by surveyors at the March survey was "flawless." According to Petitioner, that allegedly flawless care proves that there were no systemic failures by it to provide care to residents with pressure sores. Petitioner's brief at 8. I find this argument to be unpersuasive. First, the surveyors who conducted the March survey did not find Petitioner's care of the nine residents whose care was not cited as being deficient to have been flawless. They merely concluded that the care was not an additional basis for finding Petitioner to be deficient. Indeed, Petitioner offered no evidence to show that it provided care of a good quality to the nine residents whose care is not cited in the survey report. Moreover, the fact that the facility plainly was deficient in providing care to nine of its residents is ample evidence that there was a systemic problem with the quality of the pressure sore and wound care offered by Petitioner's staff prior to the March survey. Literally, half of the residents whose records were reviewed by or who were observed by the surveyors had deficient care. That is a systemic problem by any measure.

b. Petitioner failed to comply substantially with the requirements of 42 C.F.R. � 483.20(b)(1).

The regulation in question requires a facility to make a comprehensive assessment of each of its residents' needs, using a State-specified resident assessment instrument. CMS alleges that Petitioner failed to comply with the requirements of the regulation in providing assessments to six of its residents, identified as Residents #s 4, 7, 16, 17, 26, and Resident B. CMS Ex. 48, at 11 - 14.

Petitioner argues in response that, in fact, it did adequately assess the needs of all of its residents. Petitioner's brief at 18. I agree with Petitioner that, in the case of one resident, Resident # 7, Petitioner's staff performed weekly assessments of the resident's condition. P. Ex. 50, at 13 - 22. However, Petitioner failed to offer persuasive evidence as to the other five residents showing that it provided these residents with legally mandated assessments. On balance, therefore, I conclude that CMS's allegations were not rebutted by Petitioner and that Petitioner failed to comply with the requirements of 42 C.F.R. � 483.20(b)(1).

As support for its argument, Petitioner first cites, generally, to the treatment records of the six residents whose care is at issue. P. Exs. 49; 50; 51; 52; 53; and 55. I find that this blanket citation of exhibits, some of which are more than 100 pages in length, provides no support for Petitioner's contentions. In my pre-hearing orders and, in particular, in my order of February 27, 2006, I made it explicit that I would not ferret out evidence from voluminous records if the parties did not specifically bring evidence to my attention.

As for Resident # 4, Petitioner does not deny that it failed to perform assessments of the resident as was ordered by the resident's physician. However, according to Petitioner, its staff sufficiently monitored the resident's wounds through other forms of documentation. The other documentation cited by Petitioner consists of a form that is entitled "Wound Treatment Progress Record." P. Ex. 49, at 15 - 28. I find that this form does not constitute the assessment that is required by 42 C.F.R. � 483.20(b)(1). The form contains a record of care given to the resident but not a meaningful evaluation of the effect of care, the status of the residents' wounds, and the need for additional treatment.

Concerning Resident # 16, Petitioner argues that its staff was providing appropriate pressure sore care to the resident and was sufficiently documenting the resident's wounds. Petitioner's brief at 19. However, the resident's treatment record does not contain anything resembling the comprehensive assessment required by the regulation. See P. Ex. 51, at 1 - 18.

Petitioner contends that it adequately treated, monitored, and documented Resident # 17's wounds and appropriately assessed the resident's needs for pain. But, aside making a blanket reference to the resident's treatment record - a 59-page exhibit - Petitioner cites to no document that supports its contention that it provided the resident with the assessments required by regulation. See Petitioner's brief at 19; P. Ex. 52. I find Petitioner's contentions to be without merit.

Petitioner argues that it sufficiently assessed Resident # 26 on an ongoing basis. Petitioner's brief at 20. As support for this contention, Petitioner relies on the affidavit of Cathy Selph. P. Ex. 32. Ms. Selph is a registered nurse who is employed by Petitioner. In her affidavit, Ms. Selph avers that Petitioner's staff adequately treated, monitored, and cared for Resident # 26. Id. at 5. I find these conclusions to be without support. Ms. Selph does not aver that she cared personally for Resident # 26 and made the assessments required by regulation. Nor does she identify any document in the record that constitutes such an assessment.

As to Resident B, Petitioner asserts that it was providing ongoing assessments of the resident's skin condition, consistent with the resident's physician's order that assessments be made weekly. Petitioner's brief at 20 - 21. As support for this contention, Petitioner cites the resident's treatment record. P. Ex. 55, at 72, 85, 297, 300 - 342. Much of this includes nurse's notes in which observations of the resident's wounds are noted. E.g., P. Ex. 55, at 317, 318. The record also contains a Braden Scale documentation of the resident's risk for skin problems. Id. at 72. But, nowhere in the resident's record is there the comprehensive assessment that the regulation requires.

c. Petitioner failed to comply substantially with the requirements of 42 C.F.R. � 483.20(k)(2).

This regulation requires, among other things, that resident's comprehensive care plan must be periodically reviewed and revised by a team of qualified persons after each assessment of the resident. CMS contends that Petitioner failed to comply with this requirement in providing care to two of its residents, Resident B and Resident # 7. CMS Ex. 48, at 17 - 19. With respect to Resident B, CMS asserts that Petitioner created no new or updated interventions for the resident after the resident was found in December 2004 and January 2005 to have pressure sores. Id. at 18. Concerning Resident # 7, CMS argues that the resident's care plan failed to address the resident's metabolic problems and failed to discuss interventions for wound treatment that should have been implemented pursuant to a physician's orders. Id. at 18 - 19.

I find that Petitioner failed to provide a meaningful response to these allegations. Petitioner asserts that it developed, revised, and periodically updated the residents' care plans and implemented interventions in complete accord with regulatory requirements. Petitioner's brief at 21 - 22. However, Petitioner offered no evidence to support this assertion.

d. Petitioner failed to comply substantially with the requirements of 42 C.F.R. � 483.25.

This regulation states that each resident must receive and a 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 resident's comprehensive assessment and plan of care. CMS asserts that Petitioner failed to discharge its obligations pursuant to this regulation to six of its residents, identified in the survey report as Residents #s 3, 6, 12, 17, 19, and 28. CMS Ex. 48, at 23 - 27. To support this contention CMS makes the following specific assertions of deficient care:

� On March 23, 2005, a nurse was observed to be treating Resident # 17's heel wounds without determining whether the resident had received pain medication. CMS Ex. 48, at 24.

� A physician ordered a laboratory test for Resident # 6 on March 4, 2005. There was nothing in the resident's record to show that the test had been done. CMS Ex. 48, at 25.

� Treatment orders for Resident # 28 provided that the resident was to wear an air boot while in bed. The resident was observed on March 25, 2005 to be in bed without an air boot. CMS Ex. 48, at 25.

� Resident # 12 had a physician's order to be administered the drug Norvasc daily. However, the physician ordered that the medication be withheld if the resident's systolic blood pressure was above 90. The resident's record did not show that the resident's blood pressure was taken prior to being administered Norvasc. A treatment nurse admitted not taking the resident's blood pressure prior to administering the drug to the resident. CMS Ex. 48, at 25.

� Resident # 19's treatment record showed that the resident had been given incorrect amounts of insulin on 17 occasions. CMS Ex. 48, at 27.

� Resident # 3 received sliding scale insulin on only four of the 56 occasions in February 2005 when the resident should have received the medication and on only 31 of the 81 occasions in March 2005 when the resident should have received the medication. CMS Ex. 48, at 27.

I find these instances to constitute strong evidence that Petitioner was not providing its residents with care consistent with regulatory standards. Petitioner has not offered a persuasive defense.

Petitioner asserts, generally, that the residents' records show that the residents received care that comported with professional standards of care. Petitioner's brief at 36 - 37; P. Ex. 27; P. Ex. 48; P. Ex. 52; P. Ex. 59. I am not persuaded by this assertion or by the evidence that Petitioner cites in support of it. Essentially, Petitioner makes blanket citations to voluminous treatment records without identifying anything in those records that responds to CMS's specific evidence of noncompliance. CMS made specific allegations of failures to provide care by Petitioner's staff. That called for specific proof by Petitioner that the care was provided. A general assertion of compliance supported only by blanket citations to voluminous records is not a satisfactory response.

With respect to Resident # 17, Petitioner argues that it was, in fact, attentive to the resident's need for pain management. Petitioner's brief at 37. Petitioner argues that, on occasion, the resident would decline pain medication. It contends that it dealt with this issue by incorporating pain medications into routine medication administration. Moreover, according to Petitioner, the resident's complaints of pain related to his arthritic knees and not to pressure sores.

As support for these contentions Petitioner relies again on the testimony of Ms. Selph. P. Ex. 32, at 5. Ms. Selph makes statements in her affidavit that mirror the arguments in Petitioner's brief. Id. I find them to be unpersuasive. Ms. Selph does not allege to have personal knowledge of, or to have provided care to, Resident # 17. Nowhere in her affidavit does she provide any foundation for her statements.

e. Petitioner failed to comply substantially with the requirements of 42 C.F.R. � 483.20(k)(3)(i).

The regulation at issue here requires that a facility must provide or arrange services that meet professional standards of quality. CMS contends that Petitioner failed to meet this requirement in providing care to all 18 of its residents who were diagnosed with pressure sores as of the March survey. CMS Ex. 48, at 19 - 21. It asserts that Petitioner failed to assess, care plan, and treat residents who had pressure sores and to intervene appropriately to deal with blood sugar problems for residents having sores. Id.

CMS's allegations of noncompliance with the regulation essentially derive from the allegations which it made, and which I have sustained, concerning Petitioner's failure to rely on other regulations. In particular, CMS asserts that I may infer Petitioner's failure to meet the quality of care requirements of 42 C.F.R. � 483.20(k)(3)(i) from its noncompliance with the requirements of 42 C.F.R. �� 483.25(a) (discussed at Part a. of this Finding) and 483.25 (discussed at Part d. of this Finding). ⁽⁴⁾

The evidence relating to the two other regulations is sufficient, in my judgment, to support a finding that Petitioner failed to comply with the requirements of 42 C.F.R. � 483.20(k)(3)(i). My findings relating to these regulations are that Petitioner failed, systemically, to assess residents' needs for care and to plan and provide care that met professionally recognized standards of quality. Noncompliance with these two regulations plainly describes a failure to provide or arrange services that meet professionally recognized standards of quality.

The fact that I have excluded consideration of additional allegations of noncompliance based on CMS's failure to assert them in its briefs is not fatal to CMS's case. That is because the noncompliance with other regulations which is established and on which CMS relies is, in and of itself, sufficient to establish a deficiency under 42 C.F.R. � 483.20(k)(3)(i).

f. Petitioner failed to comply substantially with the requirements of 42 C.F.R. � 483.10(b)(11).

In relevant part this regulation requires consultation with a resident's physician and notification of that resident's family where a resident sustains an accident, or where there is a significant change in a resident's physical, mental, or psychosocial status (defined as deterioration in a resident's health, mental, or psychosocial status in either life threatening conditions or clinical complications), where there is a need to alter, discontinue, or commence a new form of treatment for the resident. CMS asserts that Petitioner failed to comply with this regulation in providing care to residents identified as Residents #s 4, 8, 17, 19, and 26, and Resident B. CMS Ex. 48, at 1 - 4. Specifically, CMS alleges that Petitioner's staff failed to notify:

� Resident B's physician on several occasions of changes in that resident's skin condition. Additionally, the staff failed to notify the resident's family that the resident had wounds on his right leg. CMS Ex. 48, at 2.

� Resident # 4's physician of an incident when the resident's blood sugar level was abnormally low. CMS Ex. 48, at 2 -3. Additionally, Petitioner's staff failed to notify or obtain orders from the resident's physician concerning a pressure sore that the resident developed. Id. at 3.

� Resident # 19's physician of an incident when that resident's blood sugar was abnormally low. CMS Ex. 48, at 3 - 4.

� Resident # 17's family of the development of wounds on the resident's heels. CMS Ex. 48, at 4.

� Resident # 8's physician and family of falls sustained by that resident that produced bruising. CMS Ex. 48, at 4.

� Resident # 26's family of the development of a pressure sore on that resident's buttocks. CMS Ex. 48, at 4.

These allegations are sufficient to establish a violation of the regulation if not refuted by Petitioner. The changes discussed in the allegations are significant. Development of skin sores and wounds by residents, and of falls by another resident, were clinical complications or accidents that necessitated physician consultation and family notification. So also were the incidents of abnormally low blood sugar manifested by two residents.

Petitioner argues that the changes documented by CMS were not "significant." It asserts that the wounds and pressure sores for the relevant residents:

had not developed and changed to the extent identified on the . . . [survey report], and when there were significant changes with wounds and pressure sores, Facility staff promptly notified the appropriate physician and/or family members or representatives. Further, the falls and the changes in the blood glucose values did not constitute significant changes as defined under the regulations.

Petitioner's brief at 31. However, Petitioner cites no evidence to support this assertion.

Additionally, Petitioner claims that excerpts from the residents' treatment records show that it appropriately treated and cared for its residents. Petitioner's brief at 31; P. Ex. 49; P. Ex. 52; P. Ex. 53; P. Ex. 55; P. Ex. 58. Petitioner has identified nothing specific in its residents' records that support its argument. Rather, it has chosen to make blanket citations to voluminous documents. I find that tactic to be unpersuasive.

g. Petitioner failed to comply substantially with the requirements of 42 C.F.R. � 483.20(k)

The regulation that is at issue here requires, among other things, that a facility develop a comprehensive care plan for each resident that includes measurable objectives and timetables to meet a resident's medical, nursing and mental and psychosocial needs that are identified in the resident's comprehensive assessment. CMS argues that Petitioner failed to comply with the regulation in that it failed to develop comprehensive care plans for three residents, identified in the survey report as Residents #s 3, 7, and 27, that addressed the residents' conditions, risks, and needs. CMS Ex. 48, at 15 - 17.

With respect to Resident # 3, CMS avers that the resident had developed a Stage II pressure sore in March 2005. However, the resident's care plan had not been revised to show how that sore would be treated. CMS Ex. 48, at 16. As concerns Resident # 7, CMS contends that the resident's care plan was inadequate because it did not specify interventions for the resident's pressure sore other than a pressure relieving cushion. Id. at 16 - 17. In the case of Resident # 27, CMS avers that the resident's care plan identified the resident as being at risk for impaired skin. Id. at 17. However, the plan did not specify any individualized interventions for the resident other than to provide pressure relieving measures. Id.

These examples, if not refuted by Petitioner, are sufficient to establish a failure by Petitioner to comply with the regulation. From these examples I may infer that Petitioner failed to plan comprehensively for the needs of some of its residents.

Petitioner has not refuted CMS's allegations. In response to them it states the conclusion that:

As the excerpts from the resident records show, the Facility's monitoring and care planning for these residents was sufficient to meet the residents' needs and in substantial compliance with regulatory compliance.

Petitioner's brief at 36. In support of this conclusion Petitioner makes a blanket citation to treatment records. P. Ex. 48; P. Ex. 50; P. Ex. 54. Petitioner makes no effort to explain what exists in these voluminous documents that support its contention. I find this presentation to be inadequate.

h. Petitioner failed to comply substantially with the requirements of 42 C.F.R. � 483.20(k)(3)(ii).

This regulation requires that services provided or arranged by a facility for a resident must be provided by qualified persons in accordance with the resident's written plan of care. CMS alleges that Petitioner failed to comply with the regulation because it failed, in the cases of three residents who are identified as Residents #s 3, 17, and 34, to follow those residents' written plans of care. CMS Ex. 48, at 21 - 23.

In the case of Resident # 34, CMS avers that the resident's plan of care directed that the resident wear waffle boots as a pressure relieving device. However, on March 23, 2005, the resident was observed not to be wearing waffle boots. CMS Ex. 48, at 22. As concerns Resident # 17, the resident's care plan ordered that the resident wear air boots as a pressure relieving device. However, on March 22, 2005, the resident was observed to be in bed without air boots. Id. In the case of Resident # 3, the resident's care plan directed that the resident be supplied with pressure relieving devices. Notwithstanding, the surveyors observed the resident seated on a plastic cushion that was not a pressure relieving device. Id. at 22 - 23.

These allegations establish three instances in which Petitioner's staff failed to follow the directives set out in residents' care plans. If not rebutted by Petitioner, they establish noncompliance with the regulation.

Petitioner failed to rebut CMS's allegations. As it did in other instances, it makes a broad assertion that, in fact, it was complying with the requirement. Petitioner's brief at 36. It does not deny CMS's allegations. Rather, it cites generally to exhibits consisting of voluminous resident treatment records without pointing to a single document in those exhibits that would refute the surveyors' observations. See P. Ex. 27; P. Ex. 48; P. Ex 52; P. Ex. 60. This blanket citation is not persuasive.

3. CMS's determination that some of Petitioner's deficiencies were at the immediate jeopardy level of noncompliance is not clearly erroneous.

CMS determined that four of the deficiencies that I have sustained here were so egregious as to constitute immediate jeopardy for Petitioner's residents. These were Petitioner's failure to comply with: 42 C.F.R. � 483.25(a) (discussed at Finding 2, part a.); � 483.20(b)(1) (discussed at Finding 2, part b.); � 483.20(k)(2) (discussed at Finding 2, part c.); and � 483.20(k)(3)(i) (discussed at Finding 2, part e.). I find CMS's determinations that these were immediate jeopardy level deficiencies not to be clearly erroneous.

An "immediate jeopardy" level deficiency is one that is so egregious that a facility's noncompliance:

has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident.

42 C.F.R. � 488.301.

Immediate jeopardy thus may exist in two circumstances: first, where there is proof that noncompliance has caused serious injury, harm, impairment, or death to a resident or residents of a facility; and second, where there is no proof of actual serious injury, harm, impairment, or death to a resident, but where such would be the likely consequence of continued noncompliance.

The regulation does not define the term "likely to cause." I find it to be a measure of probability. An outcome must be more than simply a possibility in order to be likely to occur. In other cases, I have held that an event is likely to occur when it is more probable than not that it will occur. I use that standard here to decide whether a likelihood of serious injury, harm, impairment, or death to a resident existed as a consequence of Petitioner's noncompliance.

A facility faces a heavy burden in challenging a determination that a deficiency was at the immediate jeopardy level. The facility must prove that CMS's determination was clearly erroneous in order to sustain its challenge. 42 C.F.R. � 498.60.

There is more than substantial evidence in this case that the four deficiencies that were cited at the immediate jeopardy level of noncompliance created a likelihood that residents of Petitioner's facility would suffer serious injury, harm, impairment, or death. The weight of the evidence in this case is that, for a period of weeks preceding the March survey, Petitioner's care of residents who suffered from pressure sores and other skin wounds was slipshod at best. Residents were not being assessed for problems. Skin care was not being planned. Petitioner's staff failed to communicate with residents' physicians and families. Care that was ordered by residents' physicians was not provided.

The systemic failures to provide care to residents was not a trivial matter. It is evident from the evidence presented by the parties that some of these residents were in very poor condition. It is highly probable that these residents would have suffered life-threatening complications had Petitioner's deficient care continued unabated.

Petitioner makes three broad arguments attacking CMS's determination of immediate jeopardy. First, Petitioner contends that CMS's own standards for determining immediate jeopardy, as set forth in a 2004 revision to the State Operations Manual (SOM), preclude determining immediate jeopardy given the facts of this case. Second, Petitioner argues that there is no proof that any of the residents were actually harmed by Petitioner's deficient conduct. Finally, Petitioner asserts that some of CMS's immediate jeopardy findings derive from other findings of noncompliance that were not at the immediate jeopardy level. Petitioner asserts that it is illogical and contrary to regulatory requirements that CMS morph findings of non-immediate jeopardy level deficiencies into findings of immediate jeopardy level deficiencies. I find each of these arguments to be unpersuasive.

Petitioner's first argument is that the SOM provides examples of situations that are immediate jeopardy which simply are not present here. Petitioner's brief at 5 - 6. Petitioner reasons that, if none of the examples cited by the SOM are present here, then there can be no immediate jeopardy.

Petitioner misreads the SOM. The section cited by Petitioner, contained at Appendix PP of the SOM - Guidance to Surveyors for Long Term Care Facilities - does not preclude a finding of immediate jeopardy based on the established facts of this case. What Petitioner relies on is a section that cites "[e]xamples of possible negative outcomes." Petitioner's brief at 5, citing SOM, Appendix PP. The examples include: development of avoidable Stage IV pressure ulcers; admission with a Stage IV ulcer that shows no signs of healing or shows signs of deterioration; Stage III or IV ulcers with associated soft tissue or systemic infection; and extensive failure in multiple areas of pressure ulcer care. Id.

But, the plain language of the SOM makes it obvious that these are only examples of the kinds of negative outcomes that might result in findings of immediate jeopardy. There is nothing in the SOM that says that such outcomes must be present in order for there to be immediate jeopardy. Moreover, in this case, the likelihood was that, if Petitioner's noncompliance remained unchecked, disastrous outcomes would have ensued for some of Petitioner's residents including, in all probability, those outcomes cited as examples by the SOM.

Petitioner also relies on the fact that the SOM does not specify that instances where Stage II pressure ulcers result from inappropriate care constitute examples of immediate jeopardy. This does not support Petitioner's case, however. It may be that immediate jeopardy would not exist if the worst likely outcome of a facility's deficient care is a Stage II sore. But here, the prima facie evidence offered by CMS satisfies me that the likelihood was that Petitioner's deficient care of its residents would have led inevitably to much worse consequences for those residents than mere Stage II sores. Petitioner did not show this evidence, or the conclusion advocated by CMS from that evidence, to be clearly erroneous.

As to the absence of actual harm, I agree with Petitioner that CMS failed to offer evidence showing what, if any, harm actually resulted from Petitioner's noncompliance. CMS made no effort to show that residents developed sores as a result of deficient care. Nor did CMS make an effort to demonstrate that sores worsened or did not heal as a result of deficient care. However, proving actual harm is not a prerequisite to establishing an immediate jeopardy level deficiency. As I discuss above, it is the likelihood of harm that drives my decision in this case, not the presence of harm.

Finally, I do not agree with Petitioner's argument that a finding of immediate jeopardy must be ruled out because a deficiency is based in part on other, non-immediate jeopardy level deficiencies. That argument applies essentially to the finding that Petitioner's noncompliance with 42 C.F.R. � 483.20(k)(3)(i) (part e. of Finding 2) was at the immediate jeopardy level. As Petitioner correctly points out, some of the other deficiencies from which this deficiency is derived were not at the immediate jeopardy level. But, at least one of the other deficiencies was at the immediate jeopardy level and that, in and of itself, is a sufficient basis for concluding not to be clearly erroneous CMS's determination that Petitioner's noncompliance with 42 C.F.R. � 483.20(k)(3)(i) was at the immediate jeopardy level.

4. The duration of Petitioner's immediate jeopardy level noncompliance was from March 24, 2005 through March 26, 2005.

CMS determined that Petitioner's noncompliance at the immediate jeopardy level persisted until Petitioner was certified to have corrected all of its deficiencies on April 11, 2005. I find this determination to be incorrect. The preponderance of the evidence establishes that Petitioner abated its immediate jeopardy level noncompliance on March 26, 2005.

CMS offered no evidence to explain why it determined Petitioner's noncompliance to persist at the immediate jeopardy level until April 11, 2005. CMS's argument, essentially, is that it was justified in concluding that Petitioner did not abate its immediate jeopardy until April 11 because Petitioner represented in its plan of correction that it would not fully complete its corrective actions until that date. CMS's brief at 19; CMS Ex. 48. CMS argues also that there is a presumption that a facility found not to be compliant remains so until it proves that it has attained compliance with participation requirements. Id. at 17. It asserts that it is relying on the presumption, along with the representations made by Petitioner in its plan of correction, to conclude that Petitioner's deficiencies persisted at the immediate jeopardy level until April 11, 2005.

The problem with CMS's argument lies in its failure to even consider the extensive evidence offered by Petitioner showing that it abated the immediate jeopardy level deficiencies by March 26, 2005. ⁽⁵⁾ That evidence addresses the heart of those deficiencies and I am satisfied by it that Petitioner eliminated its most egregious problems by March 26. It did so by taking steps that directly and aggressively responded to the most egregious deficiency findings made at the March survey.

I infer from that evidence that much, if not all, of Petitioner's problems caring for residents' pressure sores may have been the consequence of the job performance of a wound care nurse who resigned from Petitioner's employment on February 21, 2005. P. Ex. 35, at 6. Petitioner hired a new wound care nurse in March 2005 and it is apparent that this individual was far more diligent than her predecessor in keeping track of the residents' skin problems and assuring that they were cared for appropriately.

The March survey galvanized Petitioner and its staff into taking immediate steps to correct deficiencies. On March 23, 2005, while the survey was ongoing, Petitioner's staff performed a skin assessment of every resident in Petitioner's facility. P. Ex. 32, at 13; P. Ex. 37. Subsequently, all of Petitioner's residents continued to have full body skin assessments performed on a weekly basis. P. Ex. 29; P. Ex. 38. These measures directly addressed one of the central findings of noncompliance made in the March survey report, that Petitioner was not performing assessments of its residents' skin condition.

Petitioner also completed steps by March 26, 2005 to assure that residents' wounds were cared for appropriately. These addressed directly the second major finding of the March survey, that Petitioner and its staff were failing to care for pressure sores adequately, in addition to not assessing them appropriately.

After completion of the March survey, Petitioner's administrator personally reviewed residents' treatment records daily for two weeks in order to assure that the residents received prescribed care. P. Ex. 35, at 7. By March 26, 2005 Petitioner's licensed nursing staff completed a review of the care plans for all residents with wounds and confirmed that these residents were receiving the care that had been ordered for them. P. Ex. 32, at 14 - 15. The care plans were also reviewed to make sure that the treatments directed by the plans were appropriate. Id. Care plans were updated as necessary. Id. Petitioner's director of nursing reviewed resident treatment records to assure that all residents who were at risk for wounds or who had pressure sores were correctly identified. Id. at 14. Additionally, beginning immediately after the survey during the ensuing two weeks, the director of nursing accompanied Petitioner's wound care nurse on rounds three or four times every other day to assure that the wound care nurse was providing adequate care. Id. at 15. During this period the director of nursing also checked each resident with sores or wounds daily to assure that wound care dressings were applied properly. Id. at 16.

By March 26, 2005, Petitioner addressed a third finding of the February survey, that Petitioner's staff was not communicating adequately with Petitioner's dietician about residents' nutritional needs. By March 26, Petitioner implemented a process to assure that referrals to the dietician were reviewed weekly at Petitioner's interdisciplinary team's wound care meeting. P. Ex. 32, at 13. Additionally, by March 26 Petitioner had its dietician complete a review of all of the residents listed on Petitioner's weekly wound tracking worksheet. P. Ex. 43.

The fact that Petitioner filed a plan of correction in which it averred that it would attain substantial compliance by April 11, 2005 does not derogate from my conclusion that Petitioner abated immediate jeopardy by March 26, 2005. The plan of correction merely represents that all deficiencies would be corrected completely by April 11, 2005. It does not represent that it would take that long to abate immediate jeopardy. Indeed, Petitioner's abatement of immediate jeopardy by March 26, 2005 is entirely consistent with its plan of correction.

5. Petitioner did not prove that it attained full compliance with participation requirements prior to April 11, 2005.

I do not find that Petitioner attained full compliance with participation requirements prior to April 11, 2005, although I find that it abated all immediate jeopardy by March 26, 2005. Petitioner has not contended that it eliminated all of its deficiencies prior to April 11. Moreover, it represented in its plan of correction that it would not complete its corrective actions prior to April 11. Petitioner has not asserted this representation to be in error.

6. Civil money penalties of $3,050 per day for each day of the March 24 - 26, 2005 period are a reasonable remedy for Petitioner's immediate jeopardy level noncompliance.

I impose civil money penalties of $3,050 per day to remedy Petitioner's noncompliance for the three-day period that began on March 24 and ran through March 26, 2005. I do not find reasonable CMS's determination to impose penalties of $5,000 per day to remedy Petitioner's immediate jeopardy level noncompliance.

Civil money penalties to remedy immediate jeopardy level deficiencies may fall within a range of penalties of from $3,050 to $10,000 per day. 42 C.F.R. � 488.438(a)(1)(i). Determining the precise amount of such penalties depends on evaluation of evidence pursuant to regulatory factors set forth at 42 C.F.R. � 488.438(f)(1) - (4) and 42 C.F.R. � 488.404 (incorporated by reference into 42 C.F.R. � 488.438(f)(3)). The regulatory factors that may be considered include: the seriousness of deficiencies; the interrelationship of deficiencies; a facility's culpability for its deficiencies; a facility's compliance history; and a facility's financial ability to pay the penalties.

CMS offered no explanation as to how it came up with the penalty amount of $5,000 per day except to say that the seriousness of Petitioner's immediate jeopardy level deficiencies is justification enough for the penalty amount. CMS's brief at 19. I find this assertion to be unpersuasive. As I discuss above, at Finding 3, CMS did not invest any effort into demonstrating the actual - as opposed to the likely - impact of Petitioner's noncompliance on the health and welfare of Petitioner's residents. There is no persuasive proof in this case, no cause and effect evidence, showing that dereliction of duty by Petitioner's staff caused residents to suffer unnecessary pressure sores or showing that sores worsened unnecessarily. Indeed, I cannot conclude from the evidence of record that any resident developed a sore that he or she would not have developed but for appropriate intervention by Petitioner's staff. ⁽⁶⁾

Consequently, I cannot assess the seriousness of Petitioner's noncompliance between March 24 and 26, 2005 beyond saying that the noncompliance was at the immediate jeopardy level. CMS's failure to provide me with persuasive evidence of the seriousness of the deficiencies leads me to conclude that any penalty above the minimum immediate jeopardy amount $3,050 per day would be unreasonable.

7. I remand to CMS for a possible additional remedy determination the period of Petitioner's noncompliance beginning March 27 and running through April 11, 2005.

It is appropriate that I remand to CMS the issue of what, if any, penalties to impose during the March 27 - April 11, 2005 period. Neither party has addressed the issue of what penalties would be appropriate to remedy Petitioner's non-immediate jeopardy level deficiencies during that period. CMS has made no determination as to what it would impose for such deficiencies.

The issue of what penalties to impose against Petitioner for noncompliance at the non-immediate jeopardy level during the March 27 - April 11, 2005 period is a new issue. I have authority to remand the case to CMS for an additional determination to address a new issue and I exercise that authority here. 42 C.F.R. � 498.56(d). CMS may, if it chooses to do so, impose civil money penalties against Petitioner for its noncompliance during the period that ran from March 27 through April 11, 2005. My remand is subject to the following conditions:

� CMS may not impose penalties for any alleged deficiencies that it did not brief and that I did not decide here. These consist of the deficiencies that are cited at Tags 166, 176, 221, 225, 325, 353, 490, and 514 of the March survey report. My decision that CMS effectively abandoned those deficiencies because it did not brief them means that they are no longer at issue and may not be used by CMS as the basis for a remedy determination.

� Any civil money penalties that CMS determines to impose to remedy noncompliance during the March 27 - April 11, 2005 period must fall within the range of between $50 and $3,000 per day that is reserved for non-immediate jeopardy level deficiencies. 42 C.F.R. � 488.438(a)(1)(ii). I express no opinion at this time as to what penalties within that range might be reasonable.

� Petitioner has a right to request a hearing to challenge any penalties that CMS determines to impose to remedy noncompliance during the March 27 - April 11, 2005 period. If penalties are imposed and Petitioner requests a hearing the only issue that I will hear and decide is the reasonableness of the penalty amount or amounts.

Steven T. Kessel

Administrative Law Judge

1. The deficiencies not addressed substantively by CMS are described at Tags 166, 176, 221, 225, 325, 353, 490, and 514 of the March survey report. CMS Ex. 48; CMS's brief at 16 - 17.

2. As support for this contention Petitioner cites to P. Ex. 55 at 300 - 342. In my February 27, 2006 order, I expressly warned the parties not to make blanket citations but to cite to the specific entries in documents that they believed supported their contentions. Petitioner's blanket citation here provides no support for its very general assertion that it was, in fact, providing care that was consistent with regulatory requirements.

3. Petitioner makes this same argument with respect to Residents #s 1, 3, 7, 16, 26, and 27. Petitioner's brief at 8 - 9. Petitioner's theory is that, as a matter of law and policy, the presence of sores that are Stage I or Stage II pressure sores cannot justify a finding of an immediate jeopardy level deficiency. At Finding 3, below, I explain why I do not find this theory to be persuasive.

4. CMS also asserts that Petitioner's noncompliance may be inferred from its alleged failure to comply with another regulation, 42 C.F.R. � 483.25(i)(1). See CMS Ex. 48, at 41 - 42. However, this is one of the deficiency citations that CMS did not address in its brief and I have excluded allegations about this citation from consideration.

5. Petitioner completed its pre-hearing exchange on December 3, 2005. On that date, it filed all of the exhibits on which it relies and which I cite in this Finding. Additionally, it filed a pre-hearing brief on December 3, 2005 that asserts essentially the identical allegations about its compliance that it now makes and relies on the same evidence on which it now relies. As a consequence, CMS had over four months within which to respond to these allegations and to the evidence Petitioner offered. However, CMS's brief says nothing about them. Nor did CMS address Petitioner's arguments and evidence in a reply brief (it had the opportunity to do so but did not file a reply). I find this failure to respond to be telling. I infer that CMS did not respond because it could say nothing that would change the picture presented by Petitioner of its post-survey compliance efforts.

6. I do not conclude that Petitioner's deficient care was irrelevant to the residents' actual skin condition. All I am saying is that it is impossible to tell what effect such deficient care may have had on the residents' condition. CMS could have called as a witness a medical expert on pressure sores. That expert might have explained how any deficient care by Petitioner contributed to the medical condition of a resident or residents. I am in no position to make such a judgment on my own.