SUBJECT:

Sable Care Center,

Petitioner,

Centers for Medicare & Medicaid Services.

DECISION

I sustain the determination of the Centers for Medicare & Medicaid Services (CMS) to withdraw Sable Care Center's (Petitioner) authority to conduct nurse aide training and competency evaluation programs. Petitioner's loss of approval to offer these programs is based on an abbreviated and partial extended survey which found a deficiency that constituted substandard quality of care at a level of actual harm to residents.

I. Background

This case came before me pursuant to a request for hearing filed by Petitioner on May 23, 2002, in accordance with section 1128A(c)(2) of the Social Security Act (Act) and 42 C.F.R. �� 488.408(g), 498.40.

On March 28, 2002, the State of Colorado Department of Public Health and Environment (CDPHE) informed Petitioner that, based on an abbreviated and partial extended survey completed on March 14, 2002, it was imposing immediate State monitoring. CDPHE also informed Petitioner that a mandatory denial of payment for new admissions (DPNA) would be imposed if substantial compliance was not achieved within three months after the last day of the survey, and that Petitioner's provider agreement would be terminated if substantial compliance was not achieved by September 14, 2002. Finally, CDPHE notified Petitioner that, because it had been subject to a partial extended survey, a withdrawal of facility based nurse aide training and competency evaluation programs (NATCEP) and nurse aide competency evaluation programs (NACEP), was imposed for a period of two years. ⁽¹⁾ CMS exhibit (Ex.) 4. The only remedy remaining in this case is the withdrawal of NATCEP.

I held a hearing in this case in Denver, Colorado, from April 27 through April 29, 2004. CMS offered 33 exhibits, identified as CMS Exs. 1 - 33. Petitioner offered 35 exhibits, identified as P. Exs. 1, 2, and 4 - 36. The parties' exhibits were admitted into evidence without objection.

Subsequent to the hearing, the parties submitted 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 Petitioner was not in substantial compliance with participation requirements for long-term care facilities in the Medicare and/or Medicaid programs. I further find that CMS was authorized to withdraw authorization for Petitioner's NATCEP for a period of two years commencing on March 14, 2002.

II. Applicable Law and Regulations

Petitioner is considered a long-term care facility under the Act and regulations promulgated by the Secretary 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.

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. Part 483 of 42 C.F.R. 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.

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.

The program participation requirement found at 42 C.F.R. � 483.25(c) sets forth a long-term care facility's obligations regarding quality of care with respect to the prevention and treatment of pressure sores. Specifically:

Based on the comprehensive assessment of a resident, the facility must ensure that - (1) A resident who enters the facility without pressure sores does not develop pressure sores unless the individual's clinical condition demonstrates that they were unavoidable; and (2) A resident having pressure sores receives necessary treatment and services to promote healing, prevent infection and prevent new sores from developing.

The Departmental Appeals Board (DAB) has stated that to meet this requirement, "a facility must ensure no resident develops pressure sores unless clinically unavoidable in order for the facility to meet the overall quality of care requirement to provide what is necessary for each resident to 'attain or maintain the highest practicable . . . well-being.'" Koester Pavilion, DAB No. 1750, at 32 (2000), citing 42 C.F.R. � 483.25; see also 56 Fed. Reg. 48,826, at 48,850 (Sept. 26, 1991). Under this regulatory standard, "a facility should go beyond merely what seems reasonable to, instead, always furnish what is necessary to prevent new sores unless clinically unavoidable." Id.; Sanctuary at Whispering Meadows, DAB No. 1925, at 21 (2004).

CMS's authority to withdraw approval of NATCEP is derived from section 1819(f)(2)(B)(iii)(I) of the Act. The statute requires that the Secretary "shall prohibit approval" of any NATCEP program if it is:

(I) offered by or in a skilled nursing facility which, within the previous 2 years -

(b) has been subject to an extended (or partial extended) survey under subsection (g)(2)(B)(i) or section 1919(g)(2)(B0(i), unless the survey shows that the facility is in compliance with the requirements of subsections (b), (c), and (d) of this section; . . .

Subsection (b) above refers to extended surveys or partial extended surveys prompted by a "substandard quality of care" finding. The term "substandard quality of care is defined at 42 C.F.R. � 488.301 to include:

one or more deficiencies related to participation requirements under . . . � 483.25, Quality of care of this chapter, which constitute either immediate jeopardy to resident health or safety; a pattern of or widespread actual harm that is not immediate jeopardy; or a widespread potential for more than minimal harm, but less than immediate jeopardy, with no actual harm.

Since 1999, 42 C.F.R. � 498.3(b)(16) has specifically defined an "initial determination" by CMS, and, therefore, a determination from which an appeal may be taken, to include:

The finding of substandard quality of care that leads to the loss by a SNF (Skilled nursing facility) or NF (nursing facility) of the approval of its nurse aide training program.

Thus, a long-term care facility may appeal the level at which CMS determines to assess its noncompliance only if a successful appeal would affect either the range of civil money penalty imposed and collected or would affect a CMS finding of substandard quality of care that results in the loss of approval for a NATCEP. 42 C.F.R. � 498.3(b)(14)(ii).

CMS must make a prima facie case that a 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), aff'd. Hillman Rehabilitation Center v. United States, No. 98-3789 (GEB) (D.N.J. May 13, 1999); Batavia Nursing and Convalescent Center, DAB No. 1904 (2004).

III. Issues

A. Whether the facility was complying substantially with federal participation requirements;

B. Whether, if Petitioner is found to be out of compliance with participation requirements, Petitioner's noncompliance constituted substandard quality of care;

C. Whether CMS is authorized to withdraw approval for Petitioner's NATCEP.

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. Petitioner was out of substantial compliance with participation requirements at the time of the survey completed on March 14, 2002, and its noncompliance constituted substandard quality of care.

B. Petitioner allowed residents to develop avoidable pressure sores, and failed to ensure that residents with pressure sores received the necessary care and services to promote healing, prevent infections, and prevent new sores from developing.

1. Resident Number 7

The surveyor findings for Resident Number 7 (R7) are summarized below, as set forth in the statement of deficiencies (also referred to as a CMS 2567). CMS Ex. 1, at 48 - 53.

R7, a closed record ⁽²⁾ sample resident, was a 25-year-old male readmitted to the facility on August 9, 2000. His diagnoses included spinocerebellar disease, brain encephalopathy, depressive disorder, urinary incontinence, anemia, swallowing dysfunction, aphasia, and seizure disorder. He was status-post-gastrostomy tube placement and peritonitis. The facility first identified R7 as having sustained a pressure sore ⁽³⁾ to the sacrum when he was documented as having a Stage IV wound to the area on October 29, 2001.

Record review and staff interview revealed the resident was at risk for development of pressure ulcers. The most recent "Pressure Sore Risk Assessment" form, according to the medical records director, was dated August 9, 2000. The form assessed the resident at high risk for skin breakdown due to being: semi-comatose, bedfast, incontinent, and having a fair nutrition status, two predisposing diseases, and a history of pressure ulcers.

While the resident was at high risk for skin breakdown, record review disclosed the presence of factors enabling him to maintain his skin integrity if the facility provided the necessary care. However, interviews beginning on March 6, 2002, with several certified nursing assistants (CNAs), revealed that, prior to October 29, 2001, the facility failed to, among other things, provide a turning and repositioning schedule, in accordance with nursing standards, to prevent skin breakdown. The record also revealed that prior to October 29, 2001, and several days thereafter, the facility failed to provide a toileting program to adequately manage the resident's incontinence.

After the pressure ulcer developed on October 29, 2001, the facility failed to take all the necessary actions to bring about healing or prevent further deterioration.

Discussion

Petitioner argues that although Surveyor Kevin Nelson testified that, based on his interviews with nurse aides and his review of CNA flow sheets, the facility was not turning and repositioning R7, he admitted on cross examination that R7's care plan did not require turning every two hours, rather, it referred to frequent turning. P. Br. at 33. Petitioner also asserts that Surveyor Nelson attempted to reconcile staff interviews with facility records (CNA flow sheets), but that the CNAs were unable to state a specific date that any concern with turning and repositioning occurred. Id. at 33. Furthermore, Petitioner relied on the testimony of R7's treating physician, Dr. Robert D. McCartney, regarding the issue of repositioning R7. Petitioner summarized Dr. McCartney's testimony as follows:

To clarify the reference to scheduled turning in his letter of February 15, 2002 ⁽⁴⁾, Dr. McCartney testified that term did not reflect any frequency for turning and repositioning and that most nursing homes do not use a specific time frame or schedule for turning residents (Tr. 526-528; P. Ex. 31 p. 1). Because the nurses notes provide information on the necessary turning and repositioning of residents, Dr. McCartney testified that he does not need to review the CNA flow sheets (Tr. 528-529). Dr. McCartney further clarified that if any turning and repositioning was not occurring, nurses would be aware of that status and intervene. (Tr. 536). Dr. McCartney testified that during his visits to his patients, he assessed the care being given to resident #7 by the facility and did not notice dirty sheets with a reeking odor of urine at any time (Tr. 529-530). P. Br. at 35.

On the issue of turning and repositioning, Petitioner also relied on the opinion of Dr. Fred Feinsod, who testified that while facilities generally turn or reposition residents every two hours, no scientific evidence or professional literature has proven that doing so is necessary to prevent pressure sores as a standard of care, and, further, that Tag F314 does not require a specific frequency for turning/repositioning a resident. Tr. 204 - 205.

As noted above, 42 C.F.R. � 483.25(c) establishes that based on a comprehensive assessment of a resident, a facility must ensure that a resident who enters the facility without pressure sores does not develop pressure sores unless the individual's clinical condition demonstrates that they were unavoidable; and, that a resident having pressure sores receives the necessary treatment and services to promote healing, prevent infection, and prevent new sores from developing.

I take notice that the development of pressure sores not only increases the cost of medical and nursing care, but also increases the mortality rate in elderly patients. See Merck Manual of Geriatrics, Section 15, Chapter 124 (Merck & Co. 2004), which offers the following criteria with respect to pressure sore reduction:

A schedule for repositioning patients should be made based on the degree to which patients are at risk for developing additional sores and the response of the tissues to pressure. Usually, patients with limited bed mobility must (emphasis added) be turned at least every two hours. A written repositioning schedule should be developed . . .

Id.

I note that the facility was not oblivious to the principles that govern appropriate care for the prevention and treatment of pressure ulcers. The facility developed a care plan for R7, due to a potential for breakdown in skin integrity, that required, among other things, a pressure reduction mattress, a two person assist with transfers to tilt recliner once a day, a two person total assist with bed mobility, weekly skin assessments with notification to the treating physician of any changes in skin integrity, two person total assistance with peri-care after each incontinent episode, and frequent turning and repositioning. CMS Ex. 21, at 152. The facility staff appears to have interpreted frequent repositioning to mean every two hours, inasmuch as the CNA flow sheet contains an entry dated August 9, 2000, directing the CNAs to turn/reposition and offer fluids every two hours. CMS Ex. 21, at 121. This approach seems to be somewhat in harmony with the facility's Pressure Ulcer Prevention and Skin Care Program. P. Ex. 14. I say "somewhat" because the facility protocol for at risk residents calls for repositioning every two hours; except that, if the resident is chair bound, repositioning should occur every hour. Id. at 25. The copy of the protocol provided by the facility had a handwritten parenthetical insertion explaining that repositioning every hour should be understood to mean the same as frequently. Id. Even if my assumption is incorrect, there is no other way to interpret the facility's understanding of frequent repositioning to mean anything less than at least every two hours. This is also consistent with the criteria expressed in the Merck Manual of Geriatrics, cited above, that patients with limited mobility must be turned every two hours. Since R7's mobility was less than limited, as he was semi-comatose, it is a reasonable inference that the facility felt that repositioning more frequently than every two hours was appropriate in his case, and that may be why it employed the term frequent in the care plan as opposed to every two hours. Thus, I find that the facility did have a turning/repositioning schedule that called for repositioning not less frequently than every two hours, but the facility failed to comply with it (as discussed below). I cannot conceive that use of the term frequent turning and repositioning, as employed in the facility records, could be understood to mean repositioning less frequently than every two hours.

Surveyor Nelson was unable to observe the care given to R7, as the resident was no longer in the facility. However, upon review of the facility records, he determined that R7 was not being repositioned every two hours, as reflected in the CNA flow sheet for October, 2001. CMS Ex. 21, at 121. This is in contrast to the flow sheet for November, 2001, which shows that R7 was repositioned on a scheduled basis of every two hours. CMS Ex. 21, at 123; Tr. 41 - 47. During interviews with CNAs who provided direct care to R7, Surveyor Nelson learned that staff were aware that the resident was not being repositioned every two hours. The CNAs admitted that they were not always able to reposition, and that on occasion they found that the resident had not been turned in the shift preceding theirs. This was evident to the CNAs interviewed, from finding the resident in the same position they had seen him in the previous night and from brown and dried urine stains on his mattress pad. Tr. 38. Petitioner argues that Surveyor Nelson testified that CNAs were unable to state a specific date that any concern with turning and repositioning occurred. P. Br. at 33. This argument overlooks the fact that Surveyor Nelson testified that, based on the CNA flow sheet for October, 2001, CNAs reported that they were not always able to reposition the resident because of their busy schedules. Even if the CNAs could not specifically recall the problems they had encountered on a specific date, they were able to recall that they did have work schedule problems preventing them from turning/repositioning R7 in October, 2001. I thus find that the reports obtained by the surveyor from the CNAs were sufficient to corroborate that the gaps shown on the flow sheet for October, 2001, credibly reflect a failure to reposition the resident as scheduled. Tr. 46, 47, 58, 59. Petitioner has not presented evidence to demonstrate that R7 was in fact repositioned every two hours, as was required in order to prevent the development of pressure sores, especially during the days leading up to the finding of a pressure sore on October 29, 2001. CMS Ex. 21, at 80. In fact, Petitioner contends that repositioning less frequently than every two hours was appropriate for R7. This is evident from Petitioner's assertion that Surveyor Nelson admitted that the nurse aides told him that they did do turning and repositioning, but may not have done so every two hours. P. Response at 8. See also Tr. 48. This argument shows that the facility failed to turn and reposition R7 at least every two hours, and made him a likely candidate for developing pressure sores. Moreover, it is a recognition that the facility ignored its assessment that the resident was at high risk for developing pressure sores.

Petitioner further argues that the gaps in the CNA flow sheet for October, 2001, only show that no documentation was done for the days prior to October 29, 2001, and that any other interpretation of the CNA flow sheets, for instance for incontinence care, would imply that R7 had "three days of feces in his bed" which, according to Dr. McCartney, did not occur. P. Br. at 35; Tr. 529. The argument is unavailing. The credible evidence of record is that the facility failed to reposition R7 as required. Petitioner cannot overcome that evidence by arguing that it also failed to document the care given to that resident.

Dr. McCartney testified that if any turning and repositioning was not occurring, nurses would be aware of that status and intervene. P. Br. at 35; Tr. 536. The issue, however, is not whether the nurses were aware of the care being given to R7, but how they responded to that awareness. According to the CNAs, they did inform the nurses of the fact that R7 was developing a reddened area in the buttocks, but no aggressive response to prevent the development of pressure ulcers was undertaken. Tr. 58, 59. I also attribute little probative weight to the testimony of Dr. McCartney, noted above, that, if any turning and repositioning was not occurring, nurses would be aware of that status and intervene. Tr. 536. The testimony is based on an assumption that is not supported by the evidence of record. Nowhere in the record is it reflected that the nurses took aggressive action to ensure that the resident was repositioned on a consistent basis.

Dr. Fred M. Feinsod testified that the standard, to change position every two hours, has come under scrutiny in terms of the lack of literature supporting the need for changing position every two hours. Tr. 203. However, he went on to say that someone with a number of risk factors may require repositioning more frequently than every two hours. Tr. 204. Inasmuch as the record reflects that R7 was at high risk for developing pressure sores, according to Dr. Feinsod's testimony, repositioning more frequently than every two hours would have been appropriate. Based on the Pressure Sore Risk Assessment prepared on August 9, 2000, the facility rated R7 as being at very high risk for developing pressure ulcers. The rating form indicates that a total score of 8 or above represents high risk, and R7 had a score of 13. CMS Ex. 21, at 13. Consequently, I interpret Dr. Feinsod's testimony to mean that a standard of repositioning residents every two hours, across the board, has no scientific support. I agree. The repositioning schedule for each resident has to be established on the basis of an individualized assessment.

Thus far, I have considered Petitioner's inadequate care referable to the failure to reposition R7 every two hours in keeping with its Pressure Ulcer Prevention and Skin Care Program, resident care plan, and resident risk assessment. This is only one aspect of ulcer prevention and skin care management, inasmuch as preventive regimens include not only pressure reduction, but also such factors as moisture reduction and nutritional support. Thus, a facility must take an approach to prevent pressure ulcers that addresses all of the factors encompassed in maintaining skin integrity. Tr. 199 - 200.

Surveyor Nelson testified that, upon interview, facility CNAs admitted that they were not always able to provide the care needed by the residents. Some reported that when they began their shift they would find residents very wet or soaked. They also referred to dry, brown stains they found on occasion as "urine stains" that had dried and had set in the pad that had not been changed, which indicated that turning and repositioning had not been done because assistance for toileting had not been done. Surveyor Nelson specifically recalled speaking to a nurse named Diane and another nurse named Virginia Sandoval about what the CNAs told him. They both reported that they often found R7 wet with urine on his peri area. Tr. 38 - 41.

Petitioner argues that little weight should be given to CMS's conclusions because they are based on hearsay evidence from interviews of unidentified staff and closed record reviews. P. Response at 23. Hearsay evidence that is unreliable would certainly carry little weight, even in administrative proceedings. However, it has been shown that the information obtained from the direct care staff, and that is questioned by Petitioner, is supported by the facility records. Additionally, Surveyor Nelson named two nurses as sources of the information obtained; i.e., Diane and Virginia Sandoval. Petitioner has not indicated that these nurses were not in a position to provide the information testified to by Surveyor Nelson. Petitioner did offer the testimony of Nurse Sandoval, but her testimony did not refute the findings of the surveyor. In viewing the evidence of record, I note that it would not have been an insurmountable task for Petitioner to identify the staff nurses interviewed by Surveyor Nelson and offer their testimony in an effort to refute CMS's conclusions.

It has been established that the facility did not take the proper measures to provide pressure reduction and moisture reduction care to R7. The consequence of that failure is that the resident developed a pressure ulcer. As stated earlier, the CNAs reported that they identified a reddened area in the buttocks, and informed the nurse. Even after the CNAs identified the reddened area in the buttocks, the problems with turning/repositioning and urine wetness persisted. Tr. 59. Thus, when the resident was found on October 29, 2001, with a Stage IV pressure ulcer on the buttocks, it should have been of no surprise to the facility. Petitioner argues that CMS has established no nexus between the alleged skin redness identified by the CNAs and the eventual development of a Stage IV pressure ulcer. Assuming that Petitioner is correct in its contention, that still does not explain why the facility was unable to detect the pressure ulcer when it was still in any of the of the earlier stages of development. Petitioner has not shown that the pressure ulcer could not have been evident to facility staff until it was noted to be a Stage IV lesion on October 29, 2001. I infer that if the facility were repositioning the resident at least every two hours, and providing incontinent care as required, the pressure sore suffered by R7 should have been detected before it reached Stage IV. I give no credence to Dr. McCartney's statement that R7 suffered a Stage IV ulcer without going through earlier stages that could have been detected by the facility staff in the course of providing care. Dr. McCartney made such an assertion without offering logical support. P. Ex. 31. His suggestion that the ulcer experienced by R7 could progress from zero to Stage IV in 20 minutes was made without scientific basis. Tr. 499. Whereas it may only take "20 minutes of unrelieved pressure over a bony prominence to cause cessation of blood flow and irreparable damage to that tissue," it does not follow that in those 20 minutes a resident that had shown no previous indication of having a pressure sore could develop a Stage IV ulcer. ⁽⁵⁾ Tr. 499, 500. Moreover, the record is devoid of any evidence regarding the facility's measures to prevent further progression of the ulcer once a Stage I lesion was evident; that is, when the reddened area on the skin was "non-blanchable" when pressed (did not turn white). That should have been an indication to staff providing care on a daily basis to R7 that an ulcer was starting to develop.

Petitioner posits that based on Dr. McCartney's testimony it is appropriate to find that the pressure sore suffered by R7 was unavoidable. P. Br. at 37. In this regard, Dr. McCartney testified that given the resident's worsening neurological condition, seizure disorder, prior history of pressure sores, and nutritional deficiency requiring enteral feedings, pressure sores were going to occur in spite of the fact that the facility did everything to prevent sores from happening. Tr. 518.

Interestingly, in a letter written by Dr. McCartney in response to a complaint investigation regarding R7, he stated that the resident's "[skin] breakdown was a consequence of both his sweating and the incontinence, combined with his lack of mobility." He mentioned nothing as to a worsening of the resident's condition. P. Ex. 31. Contrary to the testimony given at the hearing to the effect that nutritional deficiency was a factor in the skin breakdown, the cited letter states that the resident had good nutrition. Furthermore, if it is true that R7's condition was a factor that promoted sweating, it is also true that the facility records fail to document the moisture reduction measures taken in order to prevent skin breakdown. In the absence of credible evidence that the facility repositioned the resident at least every two hours, provided proper incontinence care, or generally made diligent efforts to keep the resident dry, it cannot be concluded that the facility provided all necessary care and services to prevent the development of pressure sores. Consequently, it cannot be found that the pressure sore was unavoidable. A pressure sore can be determined to be unavoidable only if a resident's condition is such that the lesion develops notwithstanding the facility's provision of all preventive necessary care and services. Additionally, in the case of R7, the resident had demonstrated the capacity to heal previous ulcers to the sacrum. CMS Ex. 1, at 49. See CMS Ex. 21, at 14, 16.

The parties have expended much energy in discussing R7's nutritional status. However, I do not find that further analysis of the care (or lack of it) given to R7 is necessary. CMS has established a prima facie case that Petitioner failed to provide R7, a resident known to have a high risk of developing pressure sores, with all care and services to prevent the development of such pressure sores. Thus, in the case of R7, even if the facility provided prompt and adequate treatment after development of the Stage IV pressure ulcer, that does not suffice to overcome CMS's prima facie showing. ⁽⁶⁾ I conclude, therefore, that Petitioner has not overcome CMS's case by a preponderance of the evidence.

2. Resident Number 8

The surveyor findings for Resident Number 8 (R8) are summarized below, as set forth in the statement of deficiencies. CMS Ex. 1, at 53 - 55.

R8, an 85-year-old female, was admitted to the facility on December 13, 2001. She had diagnoses of closed fracture of the femoral neck, diabetes mellitus, hypertension, and organic brain syndrome. Initially, the resident was independent with bed mobility, transfers, walking, and toileting. However, following readmission from a hospital after a femoral neck repair on February 26, 2002, she required two person assistance with transfers, and was assessed as a high risk for skin breakdown due to immobility and incontinence. The interventions included: 1) repositioning every hour; 2) peri-care with every incontinence episode; 3) lotion with bathing; 4) weekly skin assessments; and 5) monitoring of fluid and meal intake.

An entry on March 1, 2002, noted an open area at coccyx, but review of the physician's telephone orders and the treatment administration record (TAR) through March 2, 2002, showed no indication that the physician was notified, as there were no wound treatment orders, and no wound assessment. Review of the care plan revealed that the existing care plan interventions were not followed, nor was the care plan updated to include the existence of a pressure sore.

The nurse described the wound to the coccyx as bright red, raw, excoriated, and bruised, and added that the excoriation and rawness was caused by being in bed. Nonetheless, the nurse asserted that he did not notify the physician, did not secure treatment orders, did not obtain wound measurements, and did not stage the wound because he did not believe it was due to pressure. Furthermore, the nurse said he applied wound gel to the resident, but did not document the treatment, and did not obtain an order for the wound gel because he did not believe that he needed one. The Director of Nursing (DON), however, confirmed that a physician's order was necessary for the application of wound gel.

On March 2, 2002, R8's condition deteriorated and she required hospitalization. At that time the resident was noted to have excoriations and pressure ulcers on her buttocks, as per the Inter-Facility Transfer Form. When she arrived at the hospital she was assessed as having a pressure ulcer, specifically assessed to be a "decubitus . . . buttocks." CMS Ex. 1, at 55.

Discussion

Petitioner contends that R8's "skin excoriation" was not caused by pressure, friction or shearing within the meaning of Tag F314. Petitioner also suggests that the testimony of Surveyor Kristy Flodquist is unreliable, because it is grounded on her review of medical records and staff interviews, without having the benefit of observing the resident. P. Br. at 45 - 46.

Based on the testimony of Dr. Feinsod, Petitioner argues that the wound to R8's coccyx was trauma related due to a fall she experienced on February 28, 2002. Thus, according to Dr. Feinsod, the wound identified by the emergency room physician was not a pressure sore. A pressure sore did not surface, stated Dr. Feinsod, until March 5, 2002. The development of that sore, maintains Petitioner, was not related to any failure of the facility to provide care and services to R8. P. Br. at 48.

CMS argues that Petitioner's contention that R8 suffered trauma related to excoriation and not a pressure sore is inconsistent with the evidence of record. CMS Br. at 18 - 22. I agree.

On February 26, 2002, a pressure sore risk assessment showed R8 to be a high risk for developing pressure sores. CMS Ex. 22, at 43. Consequently, the care plan was updated to include the following pressure sore prevention interventions: 1) repositioning every hour; 2) peri-care with each incontinence care; 3) application of lotion when bathing; 4) weekly skin assessments; and 5) monitoring of fluids and meal intake. CMS Ex. 22, at 79. Contrary to the updated care plan, the resident was repositioned every two hours instead of hourly. Tr. 386.

The nursing progress notes reflect that on March 2, 2002, R8 was transferred to the hospital on an emergency basis. At that time the facility completed an Inter-Facility Transfer Form showing both excoriations and pressure ulcers to her buttocks. CMS. Ex. 22, at 116. The emergency room assessed the resident as having a decubitus excoriation to the buttocks. CMS Ex. 22, at 102. Decubiti to the buttocks are caused by lying in bed.

Thus, the nurse who made the March 1, 2002 nursing progress note entry was accurate when he informed the surveyor on March 6, 2002, that R8's open area at the coccyx was due to being in bed. CMS Ex. 1, at 54 - 55. ⁽⁷⁾

Furthermore, there is no basis for the contention that Petitioner was excused from having to comply with the requirements of the pressure sore regulation. It does not matter whether the injury experienced by the resident met the clinical definition of a pressure sore. What matters is that the facility failed to deal with this wound despite being aware of its existence. From the record, it is clear that Petitioner provided no evidence whatsoever of care to R8 for the wound it described as an "open area to the coccyx." CMS Ex. 22, at 32. The regulation requires a facility to treat wounds that might be pressure sores as if they are pressure sores. Otherwise, wounds that are in fact pressure sores could go untreated. Here, R8 had injuries which clearly could have been pressure sores. Indeed, a facility nurse concluded that the wound was a pressure sore, as well as the hospital emergency room. Petitioner had an affirmative duty to provide care to R8 as soon as the presence of this possible sore was noted. The failure by Petitioner's staff to provide appropriate care to this resident - including a failure to at least consider whether to seek a physician's advice as to whether the injury was a pressure sore and to administer care consistent with the physician's advice - constituted a failure by Petitioner and its staff to take measures to treat the wound, to promote healing, and to prevent the development of pressure sores in the future.

Dr. Feinsod's testimony, to the effect that the emergency room physician's indication that R8 had a decubitus excoriation was not reliable, is without merit. He provided no basis for the conclusion that the emergency room physician could not make a proper assessment without being aware of the history of the resident's wound. Specifically, Dr. Feinsod opined that the emergency room physician may not have been aware of the trauma suffered by R8 [when she fell on February 28, 2002]. However, the nursing progress notes reveal that no injury was noted when R8 was found on the floor on that date. CMS Ex. 22, at 32. Inexplicably, Dr. Feinsod maintained that the "excoriation" exhibited by R8 on March 1, 2002, though not evident when she was found on the floor the previous day, could have developed sometime after the fall because of "bleeding in the tissues" and the noxious characteristics of blood "when not contained in vessels." Tr. 267. I am not persuaded by Dr. Feinsod's theory, because the wound he described was a chafing or an area where the skin had been rubbed away, and he failed to explain how an area where the skin was rubbed away by a fall could present no appearance on the day of the event, but "extravasated blood" would have the effect of scraping the skin away at a later date. Tr. 289. I am also intrigued by Dr. Feinsod's opinion that the pressure sore observed in the hospital could have developed while the resident was on a gurney in the ambulance on the way to the hospital. Tr. 268. His reasoning, however, does not consider that the facility should have been repositioning the resident every hour and was only doing it every two hours.

Finally, there is no support for Dr. Feinsod's opinion that he was in a better position to assess R8's wound by reading the nurse's notes than the emergency room physician who actually observed the resident. This is especially true when I consider that Dr. Feinsod ignored the fact that the record discloses that the Inter-Facility Transfer Form reflected that R8 had an excoriation as well as a pressure sore. The weight of the evidence in this case persuades me to find that the sores acquired by R8 were decubitus in nature.

3. Resident Number 3

The surveyor findings for Resident Number 3 (R3) are summarized below, as set forth in the statement of deficiencies. CMS Ex. 1, at 55 - 59.

R3 was a 69-year-old female admitted to the facility on September 9, 2001, with diagnoses that included status-post-cerebrovascular accident with left hemiparesis, hypertension, arteriosclerotic dementia, and anxiety. She needed extensive assistance with locomotion, and was totally dependent on staff for bed mobility, transfers, dressing, eating, personal hygiene, and incontinent care. Nutrition was provided mostly by feeding tube.

Review of the October 4, 2001 care plan revealed a risk for skin breakdown related to a history of pressure ulcers, decreased mobility, and bowel and bladder incontinence. The facility established precautionary measures that included, among other things, turning/repositioning frequently, weekly skin assessments by licensed nurse, peri-care after each incontinent episode, the use of a preventive mattress to bed and wheelchair, and encouraging the resident to eat more as opposed to significant reliance on tube feeding.

Record review of the treating physician's telephone orders from January 2, 2002 through March 12, 2002, revealed a skin treatment order on the day shift of February 13, 2002, to "[a]pply wound gel and cover site to coccyx qd (every day). Use Normal Saline (NS) to clean." CMS Ex. 1, at 56. This was based on discovery of a facility acquired pressure sore measuring .5 cm x .5 cm. The care plan was not updated to include the existence of a pressure sore until February 27, 2002, 14 days later, when the sore had increased to 1 cm x 1 cm. The surveyor also found that during the months of February and March, 2002, the facility omitted eight opportunities for pressure sore treatments that were initiated on February 13, 2002. Additionally, the facility missed four head to toe weekly skin assessments during the same period. During the survey, a surveyor specifically observed the resident in bed, without a dressing on the wound (which the physician had ordered), and with the wound uncovered, and the resident was taken to breakfast in her wheelchair without a dressing on the wound.

Discussion

Petitioner refers to the participation requirement at 42 C.F.R. � 483.25(c) (Tag F314 on the 2567) as having two "prongs." Petitioner argues that CMS failed to demonstrate that, under what it terms the second prong of Tag F314, R3's pressure sore either worsened, became infected, or that new pressure sores developed. Petitioner adds that the statement of deficiencies does not allege that, under the first prong, the facility failed to carry out the interventions listed in the care plan, nor does it allege the pressure sore discovered on February 13, 2002 was unavoidable. P. Br. at 13.

Petitioner's contention that, under the "second prong" of Tag F314, CMS has to prove that R3's pressure sore either worsened, became infected, or that new pressure sores developed, is misplaced. As noted above, 42 C.F.R. � 483.25(c) is composed of two distinct subsections; subsection (1) provides that a facility must ensure that a resident who enters the facility without pressure sores does not develop pressure sores unless that individual's clinical condition demonstrates that they were unavoidable, and subsection (2) provides that a facility must ensure that a resident having pressure sores receives necessary treatment and services to promote healing, prevent infection, and prevent new sores from developing. Under 42 C.F.R. � 483.25(c)(2), all that CMS has to establish is that the facility did not provide, to a resident with pressure sores, the necessary treatment and services to promote healing, prevent infection, and prevent new sores from developing. Thus, a violation of the regulation exists whether or not CMS establishes that the sore did not heal, become infected, or that a new sore developed.

Surveyor Flodquist testified that the facility included the risk of skin breakdown in R3's care plan based on her history of pressure ulcers, decreased mobility, and incontinence. The planned interventions included frequent turning/repositioning, weekly skin assessments by a licensed nurse, peri-care after each episode of incontinence, preventive mattress, and encouragement to eat more than 75% of meals, with supplements to be provided with tube feedings. Tr. 391.

When the resident was noted to have a pressure sore, on February 13, 2002, the treating physician ordered Normal Saline cleansing, wound gel and dressing to coccyx daily. CMS Ex. 18, at 24. Surveyor Flodquist testified that the facility did not provide wound care to the resident, as ordered by the physician, nor did it conduct weekly head to toe assessments to determine if there was additional skin breakdown. Tr. 392 - 393. A review of the facility records revealed that eight treatments out of 28 were omitted, beginning February 13, 2002, through the date of the survey that ended on March 14, 2002. Tr. 393; CMS Ex. 18, at 39; P. Ex. 9, at 9. There was no documentation on the TAR that the prescribed treatment was applied on the following days: February 16, 17, and 24, and March 3, 7, 8, 9, and 12, 2002. Id.

Petitioner contends that CMS has not demonstrated that the facility's failure to consistently provide wound care caused R3's condition to worsen or that new pressure sores developed. Dr. Feinsod, Petitioner's expert witness, testified that R3 was at high risk for skin breakdown due to immobility secondary to cerebrovascular accident, history of ethanol abuse, ⁽⁸⁾ and incontinence. Tr. 215 - 226; P. Ex. 34. Based on this medical profile and the provision of a pressure relieving mattress, pressure reducing wheelchair cushion, repositioning, hygiene, and nutrition, Dr. Feinsod opined that the pressure sore developed by R3 was unavoidable. Tr. 228 - 230. Petitioner's expert witness also testified that the CNA flow sheets showed that matters relative to hygiene were addressed and that protein reserves were maintained by good nutrition at the facility. Tr. 230. Furthermore, Dr. Feinsod stated that R3's history of pressure sores made her prone to skin breakdown despite the best of care. Tr. 225.

When a resident develops a facility acquired pressure sore, it is presumed to be avoidable unless the facility presents evidence that it was unavoidable. In this case, the facility presented evidence to refute that presumption. Except for the fact that R3 developed a pressure sore at the facility, CMS has presented no other evidence to overcome Petitioner's arguments that the pressure ulcer was unavoidable, by a preponderance of the evidence. However, notwithstanding my finding that CMS did not overcome Petitioner's showing that the pressure sore acquired by R3 in February, 2002, was unavoidable, I conclude, for the reasons that follow, that Petitioner failed to ensure that R3 received necessary treatment and services to promote healing, prevent infection, and prevent new sores from developing.

With regard to the Stage II pressure sore found on February 13, 2002, and the use of wound gel, Dr. Feinsod testified that the wound gel is a standard treatment. It bathes the pressure sore tissues, providing proper PH and nutrients. Dr. Feinsod added that wound gel also promotes a healing environment that allows the tissues to regenerate and regrow. Tr. 235. In his review of the record, Dr. Feinsod found that there were some treatment omissions on March 3, 9, and 17, 2002. These omissions he found to be isolated, and not on successive days. He referenced P. Ex. 9, at 42. Dr. Feinsod thus concluded that the wound gel was left on for an additional day and replaced on the second day. Tr. 237 - 238. Although Dr. Feinsod recognized that there was efficacy with daily treatments, he preferred skipping a day to allow for the accumulation of the of the body's drainage into the wound gel to help with the healing process. Thus, in his opinion, missing a day benefitted the resident. Tr. 241 - 242. However, this opinion is in contradiction to his statement that the physician elected daily treatments because "they wanted to do the best they could." Tr. 241. Additionally, Dr. Feinsod's testimony was based on incorrect data. The record shows that, in fact, treatments were omitted on February 16, 17, and 24, and March 3, 7, 8, 9, and 12, 2002. CMS Ex. 18, at 21, 39. The document on which Dr. Feinsod relied was P. Ex. 9, at 42. Surveyor Flodquist testified that the document referenced by Dr. Feinsod was not provided to her during the survey. The treatment record provided to her is found at CMS Ex. 18, at 39. Tr. 444 - 445. Thus, it was Ms. Flodquist's testimony that the document relied upon by the expert witness was altered. The treatment record she was provided by the facility in March, 2002, had the treatment gaps alluded to earlier. However, the treatment record that surfaced at a later date reflects that those gaps in the treatment given to R3 had been filled in, which I infer was to give the appearance of compliance with the treating physician's orders.

I find, therefore, that the facility failed to provide wound healing treatment to R3 in a manner that would promote healing. Dr. Feinsod testified that providing wound gel treatment every other day was appropriate. Nonetheless, the treatment record shows that on certain occasions two and three days elapsed with no treatment being given (February 16, 17, and 24, and March 3, 7, 8, 9, and 12, 2002). CMS Ex. 18, at 21, 39. According to Dr. Feinsod's testimony, omissions of more than a day would be inappropriate. Tr. 241 - 242, 315. Moreover, the facility did not omit treatment days due to a reasoned decision that it was more beneficial for the resident. If that were the case, the record would reveal such a pattern. What the treatment record does show is an irregular pattern of treatment applications that included a period during which two treatment days were omitted at one time, and three days on another occasion. Dr. Feinsod's testimony amounts to nothing more than a creative reconstruction of the facts as a distraction from the facility's failure to follow the treating physician's orders. In fact, on March 13, 2002, during the survey, Ms. Flodquist observed R3, in bed, without a dressing on her pressure sore. At that time, the CNA got the resident up for the day and took her to the dining room for breakfast in her wheelchair without any dressing applied to her wound. It was not until sometime after breakfast that a dressing was applied to R3. Tr. 393 - 394; CMS Ex. 1, at 58.

Although Dr. Feinsod also stated that the facility was conducting weekly skin assessments, R3's treatment record indicates that after the assessment of February 13, 2002, no other assessments were carried out in the month of February. CMS Ex. 18, at 21; Tr. 392. Thus, a review of the record does not reflect the aggressive posture on the part of the facility that Dr. Feinsod attempted to convey. Pertinent to this is the facility's failure to update the care plan to include interventions for healing the pressure sore discovered on February 13, 2002. That update is not evident until February 27, 2002. CMS Ex. 18, at 41.

CMS contends that the facility's failure to provide the necessary treatment and services to promote healing, prevent infection, and prevent new sores from developing, resulted in a worsening of R3's condition. From a review of the record in this case it is not evident that CMS established that R3's pressure ulcer took a turn for the worse after its discovery in February, 2002. On March 13, 2002, R3's pressure sore was noted to be 2 cm x 2 cm in the weekly pressure ulcer report. CMS Ex. 28. However, the nurse's notes from February 13, 2002, appear to indicate that at inception the sore was 1.5 cm x .5 cm (P. Ex. 9, at 31), and progressed as follows: 1 cm x .0 cm on February 27, 2002, 1 cm x .5 cm on March 6, 2002, 1cm x .5 cm on March 14, 2002, .5 cm x .5 cm on March 19, 2002, and .5 cm x .0 cm on March 27, 2002. P. Ex 9, at 17, 18, 32. These measurements leave no room for a conclusion that R3's condition worsened. The only conclusion that may be drawn is that the facility engaged in sloppy record keeping that was clearly contradictory. My finding that CMS has not established that a worsening of R3's pressure sore occurred is not dispositive of the issue as to whether Petitioner was in violation of 42 C.F.R. � 483.25(c)(2), however. The essence of the deficiency here is that the facility failed to implement all of the planned interventions to promote healing of the pressure sore. It matters not whether, per chance, R3's condition did not worsen, ⁽⁹⁾ infection did not set in, or new sores developed. Thus, I find that CMS established a prima facie case that the facility failed to provide R3 with the necessary treatment and services to promote healing, prevent infection, and prevent new sores from developing. Petitioner has not overcome that showing by a preponderance of the evidence. In fact, CMS proved that Petitioner's facility did not provide the required wound gel treatments to promote the healing of R3's pressure sore nor did it conduct required weekly pressure sore assessments.

4. Resident Number 4

The surveyor findings for Resident Number 4 (R4) are summarized below, as set forth in the statement of deficiencies. CMS Ex. 1, at 59 - 61.

R4, a 103-year-old female, was admitted to the facility on June 8, 1998. She had senile dementia and depressive disorder, and was totally dependent on staff for care. No skin problems were noted on admission. However, her care plan revealed a potential for skin breakdown due to immobility and incontinence. The planned interventions included weekly skin assessments; pressure reduction mattress in bed and wheelchair; one person extensive assistance with bed mobility, with frequent turning and repositioning; and nutritional support. On March 8, 2002, the care plan was updated to include the presence of a Stage II pressure sore on the left buttocks, expected to resolve in 15 days. The sore measured 2.3 cm x 3.5 cm.

A review of the March 2002 TAR revealed no evidence of a thorough wound assessment including depth, sinus tracts, undermining, tunneling, necrotic tissue, and the presence or absence of granulation tissue and epithelialization, as expected per the Agency for Health Care Policy and Research Guidelines (AHCPR) and facility policy.

On March 14, 2002, the DON reported that R4's pressure sore was 4 cm in diameter, which was larger than the previous week. That measurement, however, was at variance with subsequent agency documentation provided to the surveyor, that represented that from March 8 through March 14, 2002, the pressure sore remained at 2.3 cm x 3.5 cm.

The March TAR revealed that buttocks wound treatment initiated on March 8, 2002, was not documented for March 10, 2002. Additionally, the February and March 2002 TARs showed that the weekly head to toe assessments were omitted on five out of five opportunities, to wit: February 7, 14, 21, 28, and March 7, 2002.

Discussion

Petitioner initially appears not to refute that its facility failed to conduct the weekly skin assessments included in R4's care plan, but, rather, maintains that CMS has not shown how skin assessments prior to March 8, 2002, would have prevented the pressure sore from developing. P. Br. at 21. Later on in its brief, Petitioner argues that the facility did, in fact, conduct a weekly assessment on March 7, 2002, citing P. Ex.10, at 26. P. Br. at 23. However, the treatment record that surfaced after the survey was different than the one provided to Ms. Flodquist at the time of the survey (CMS Ex. 19, at 54), inasmuch as it did not contain an entry showing a skin assessment for March 7. I find, therefore, that P. Ex.10, at 26, lacks probative value.

Petitioner further argues that in light of Ms. Flodquist's testimony that a Stage II pressure sore can develop within a 24-hour period, weekly assessments would not be a factor in early wound detection. ⁽¹⁰⁾ P. Br. at 22.

CMS contends that Petitioner cannot minimize the importance of weekly skin assessments, inasmuch as such assessments were one of the preventive measures included in R4's care plan. CMS Ex. 19, at 68. CMS adds that although Petitioner might argue that weekly assessments were not necessary to prevent pressure sores based on Dr. Feinsod's testimony, any notion that Dr. Feinsod did not consider weekly skin assessments to be important because he did not include it as one of the five components necessary to prevent pressure sores is undercut by Petitioner's other expert witness, Dr. McCartney. Dr. McCartney testified that if a facility is not doing skin inspections it will not find early signs of pressure sores and will miss out on opportunities to prevent such sores. CMS Br. at 19; CMS Ex. 19, at 68; Tr. 542.

Petitioner appears to contend that CMS must demonstrate that conducting skin assessments prior to March 8, 2002, would have prevented R4's pressure sore. I disagree. Such direct causal relationship is unnecessary for a finding of noncompliance. The record is replete with testimony indicating that many factors come into play in the prevention as well as the origin of pressure sores. That is why the regulation requires that the facility must make a comprehensive assessment of each resident and provide every necessary care and treatment to ensure that residents without pressure sores do not develop them unless the individual's condition demonstrates that they were unavoidable. 42 C.F.R. � 483.25(c).

Thus, it cannot be concluded that a pressure sore was unavoidable unless it is first established that the facility engaged in the full complement of preventive measures. In this case the facility did not satisfy the requirement of providing those measures by failing to conduct weekly skin assessments. The importance of early detection of pressure sores was highlighted by Dr. McCartney in his testimony. Dr. McCartney stated that upon discovery of a reddened area by either the wound team or a CNA during routine care, the opportunity should be seized and the nurse notified. ⁽¹¹⁾ Tr. 540 - 541. Moreover, he cautioned as follows:

What is bad is if you're not doing your skin inspections, you don't find a red spot or anything, [and] then all of a sudden you have a horrible sore. You've missed the opportunity.

Tr. 542. The facility recognized the importance of periodic skin assessments as a pressure ulcer prevention measure in the adoption of its Skin Care Protocol. P. Ex.14, at 7. In the Protocol, CNAs are required to observe the skin daily and on bath days. Additionally, nursing staff are directed to monitor and document the presence or absence of skin conditions at least weekly, in accordance with the facility Weekly Skin Integrity Assessment plan. P. Ex. 14, at 7, 9.

Petitioner's argument regarding the significance of Ms. Flodquist's testimony that a Stage II pressure sore can develop within a 24-hour period is without merit. Ms. Flodquist testified that a resident who is not turned frequently enough may progress from a Stage I pressure sore to a Stage II pressure sore within a 24-hour period. Tr. 402. In view of Dr. Feinsod's testimony that R4 was being repositioned, it is reasonable to infer that the progression from a Stage I to Stage II pressure sore may have taken longer than 24 hours. Tr. at 255. Thus, a skin assessment conducted on March 7, 2002, would have provided the early detection testified to by Dr. McCartney. Nonetheless, the record reflects that a head to toe skin assessment scheduled for March 7, 2002, was not performed. CMS Ex. 19, at 54. Petitioner maintains that it submitted evidence of weekly skin assessments for March 7, 14, 21, and 29, 2002. However, as noted above, the March 7 entry was not present in the treatment record provided to the surveyor. P. Br. at 23. This is evident from a comparison of CMS Ex. 19, at 54, with P. Ex. 10, at 26. The surveyor's copy had no weekly skin assessment charted at any time in the month of March, 2002. The reasonable inference is that the facility made a backdated entry to convey the impression of compliance with the scheduled skin assessment of March 7, 2002. Therefore, P. Ex.10, at 26, lacks probative value.

Petitioner further references the case of Koester Pavilion, DAB No. 1750 (2000) and argues that, based on Koester, CMS must show not only that residents were admitted without pressure sores and the facility failed to provide the necessary care and services to prevent pressure sores but, further, that the subsequently developed pressure sores were avoidable. P. Br. at 6. Petitioner contends that in this case, with regard to weekly skin assessments, under Petitioner's interpretation of the standard it believes Koester stated, CMS must show that had the facility conducted an assessment on February 28, 2002, a pressure sore would have been found on R4's buttocks at that time. P. Br. at 23. Instead, according to Petitioner, the evidence shows that a physical examination by the wound nurse on March 5, 2002, did not reveal a pressure sore on R4's buttock. Id. Petitioner's reasoning is flawed because, as has been pointed out, the facility failed to conduct an assessment on March 7, 2002, and the ulcer was not discovered until March 8, 2002. Assuming that a pressure ulcer was not evident on March 5, by not conducting the March 7 scheduled weekly assessment, the facility failed to seize the opportunity of early detection. Additionally, the physical examination conducted on March 5, 2002, is not the head to toe skin assessment included in the facility's care plan, and was not specifically focused on the possibility of emerging pressure sores. P. Ex. 10, at 4 - 6. Finally, the Koester decision does not establish that weekly assessments are not part of the regulatory standard as to what services are necessary to prevent pressure sores. Koester stands for the proposition that "a facility should go beyond merely what seems reasonable to, instead, always (emphasis added) furnish what is necessary to prevent new sores unless clinically unavoidable, and to treat existing ones as needed." Koester, DAB No. 1750, at 31. I view weekly skin assessments as falling within the broad scope of what may constitute a pressure sore prevention measure.

In this case, CMS has established that Petitioner failed to ensure that R4, who entered the facility without a pressure sore, did not develop a pressure sore. Petitioner did not show that the pressure sore was unavoidable.

Additionally, the facility failed to provide a prescribed treatment for the healing of the pressure sore on March 10, 2002. Tr. 400; P. Ex. 10, at 26. Specifically, R4's pressure sore was to be cleaned, wound gel applied, and the wound was to be dressed. In this regard, Nurse Schwaninger testified that although she would expect to find an explanation for the lack of treatment on the back of the treatment record, she could find none. Tr. 633. The issue here, however, is not why the treatment was withheld or omitted, the issue is whether the treatment was provided as ordered by the treating physician. Petitioner failed to provide R4 with necessary treatment and services to promote healing, prevent infection, and prevent new sores from developing.

In view of the foregoing, I conclude that CMS has established a prima facie case that Petitioner was in violation of 42 C.F.R. � 483.25(c)(1) and (2). Petitioner has not overcome that showing by a preponderance of the evidence.

5. Resident Number 5

The surveyor findings for Resident Number 5 (R5) are summarized below, as set forth in the statement of deficiencies. CMS Ex. 1, at 61 - 64.

R5, a 70-year-old female, was admitted to the facility on June 14, 2001, with diagnoses of congestive heart failure, anxiety, depressive disorder, chronic airway obstruction, esophageal reflux, and hypothyroidism.

On March 12, 2002, R5's care plan was revised to include that she had three Stage II decubitus ulcers on her coccyx, and it explained that she would not lie down for rest periods. The care plan interventions addressed the following: 1) preventive mattress on bed and wheelchair; 2) encourage to lie down for rest periods at least daily for 1-2 hours; 3) encourage to elevate legs when possible; 4) encourage to wear Ted hose, assist with application of Ted hose every morning; 5) provide peri-care after each incontinent episode; and 6) restorative nursing to ambulate routinely.

The resident was observed and interviewed at 6:20 a.m. on March 13, 2002. She was in her room sitting in her wheelchair. R5 complained of "a sore on her bottom that really hurt," and she asserted that it had only been there "for a short time." CMS Ex. 1, at 62. She asserted also that staff did not assist/remind her to turn/reposition when she was in bed at night.

Record review on March 14, 2002, of the physician's telephone orders from January 26, 2002 through March 8, 2002, revealed that the only treatment to coccyx wounds was ordered on February 26, 2002, for Santyl Cream dressing to be changed daily. However, record review on March 13, 2002, of the March 2002 TAR, revealed no evidence of any treatments administered or documented between March 1, 2002 and March 12, 2002. Thus, R5's pressure ulcers on the coccyx were untreated for the first 12 days of March, 2002.

A review of the February and March 2002 TARs revealed omissions of five of six opportunities for weekly skin assessments. These dates include February 4, 11, 18, and 25, and March 9, 2002.

Furthermore, the surveyors' review of facility documentation found that the facility staff did not describe the pressure ulcers in sufficient detail regarding depth, drainage characteristics, sinus tracts, undermining, tunneling, necrotic, tissue, the presence or absence of granulation tissue, and epithelialization. When the DON was interviewed on March 14, 2002, she stated that the depth of a pressure sore did not need to be measured or documented for superficial (Stage II) pressure ulcers.

Discussion

Petitioner contends that Dr. Feinsod testified that to fulfill the Koester legal standard regarding the prevention of pressure sores, the following five services are necessary: pressure reduction mattress in bed, pressure relieving cushion in the wheelchair, turning and repositioning, hygiene and peri-care for incontinence, and nutritional supplements. Thus, Petitioner asserts that Dr. Feinsod's testimony excluded weekly assessments prior to onset of pressure sores as a component of the standard of care. Petitioner also argues that it was Dr. Feinsod's opinion that the facility prevention efforts met the aforementioned standard when R5 allowed it. However, her refusals of care significantly interfered with the effectiveness of the facility's prevention efforts. P. Br. at 26, 29.

CMS argues that the facility treatment record did, in fact, show that weekly skin assessments for R5 were required. CMS Br. at 30; CMS Ex. 20, at 29. However, the skin assessments planned for R5 were not performed on February 4, 11, 18, 25, and March 9, 2002. CMS Ex. 20, at 29, 35. Whereas Petitioner argues now that weekly skin assessments are of no value in the prevention of pressure sores, it considered them important enough to include them as a required treatment, as well as important enough to alter the treatment record provided to the surveyor before the completion of the survey on March 14, 2002, so as to convey the impression that skin assessments were, in fact, being performed as a preventive measure. ⁽¹²⁾ Compare CMS Ex. 20, at 35 and P. Ex. 12, at 34.

In the case of Sanctuary at Whispering Meadows, DAB No. 1925 (2004), an appellate panel of the DAB noted that the facility identified two factors (inability to ambulate and incontinence) that put the resident in question at risk for development of pressure sores. As a result, the care plan required the staff to -

1. assess skin condition daily + report weekly;
2. change +/or check [incontinence briefs] Q2 [every two hours];
3. pericare [with] incontinence;
4. turn and reposition Q2 [every two hours];
5. monitor dietary intake.

Sanctuary at Whispering Meadows, DAB No. 1925, at 23. The DAB found that the facility did not comply with all of the pressure sore preventive measures planned for the resident, including weekly assessments, and went on to say that:

Clinically unavoidable means 'not just unsurprising given the clinical condition of the resident, but incapable of prevention despite appropriate measures taken in light of the clinical risks.' Josephine Sunset Home, DAB No. 1908, at 7 (2004). Thus, as the ALJ explained, susceptibility does not mean that pressure sores are unavoidable; susceptibility to pressure sores means that Sanctuary must intervene aggressively to try to prevent pressure sores. ALJ Decision 8 . . . .

In any event, the record does not support a finding that Sanctuary followed the pressure sore plan of care that it adopted on June 3. While the plan called for daily skin assessments, there is no evidence to indicate daily assessments were made. In fact, the physician's orders and the treatment records called for weekly, not daily, assessments. Nor is there evidence that even weekly assessments were conducted. Rather, the records for July and August document occasional, but less than weekly, skin assessments.

Sanctuary at Whispering Meadows, DAB No. 1925, at 22, 25. It is thus evident that Petitioner's argument that weekly skin assessments are not a factor in pressure sore prevention is without merit. Additionally, Dr. Feinsod's legal opinion, that weekly assessments prior to the onset of pressure sores is not a component of the standard of care set forth in Koester, lacks probative value.

Petitioner further argues that R5 was non-compliant with her care. Petitioner makes reference to CMS Ex. 20, at 53 - 62, where it is shown that R5 had decreased mobility by choice, lacked motivation to do more for herself, engaged in attention seeking, would not lie down for rest periods, and had episodes of voluntary incontinence. The resident, on the other hand, asserted to the surveyor that staff did not assist/remind her to turn/reposition when she was in bed at night. CMS Ex. 1, at 62. There are indications in the record that the resident was open to motivation when properly approached. Pertinent to this is the fact that, although at times R5 refused dietary interventions to stop weight loss, she was accepting of nutritional support when encouraged by the dietician. P. Br. at 28 - 29; P. Ex. 12, at 45. On January 31, 2002, R5 fell and sustained an injury while attempting to get to the bathroom by herself. Rather than demonstrate a tendency to lean on staff for all activities of daily living, she showed enough motivation to attempt to do things by herself. In fact, when offered assistance after falling on the way to the bathroom, she indicated that she could help herself. CMS Ex. 20, at 21. The record is devoid of any multi-disciplinary approach to dealing with the resident's behavior. There is no indication that psychological help was brought to bear in order to explore whether her behavior was rooted in depression or some other emotional problem. Also, when she indicated a desire to sit in her wheelchair, the facility did not explore the possibility that the resident may have experienced difficulty breathing when lying down, as in the case when she had pneumonia. CMS Ex. 20, at 24. Moreover, the record does not reveal that at any time the resident refused a skin assessment. From the tenor of Petitioner's arguments, I infer that the scheduled skin assessments were not performed due to the resident's refusal, but, instead, because the facility considered them to be unnecessary.

The facility not only failed to ensure that the resident did not develop pressure sores, but also fell short of providing necessary treatment and services to promote healing, prevent infection, and prevent new sores from developing. In this regard, when the survey ended on March 14, 2002, the TAR revealed that no documentation existed of any pressure sore treatments administered between March 1, 2002 and March 12, 2002, although daily treatments had been ordered by the physician beginning February 26, 2002. CMS Ex. 20, at 11. Moreover, the treatment record produced by the facility subsequent to the completion of the survey showed that R5 received no pressure treatment to the buttocks area until March 18, 2002. P. Ex. 12, at 34.

I thus find that CMS has established a prima facie case of noncompliance with respect to R5. Petitioner has not overcome that showing by a preponderance of the evidence.

C. Petitioner's noncompliance with participation requirements here is sufficient to justify withdrawal of its authority to conduct NATCEP.

Petitioner lost its authorization to conduct NATCEP as a consequence of CMS's acceptance of the scope and severity determination made by CDPHE for the deficiencies cited in this case. Pursuant to applicable regulations, a facility will lose its authorization to conduct NATCEP if it manifests deficiencies that establish a substandard quality of care which leads to a partial extended survey. The term "substandard quality of care" is defined at 42 C.F.R. � 488.301 to include, among other things, a deficiency involving 42 C.F.R. � 483.25, which constitutes a pattern of or widespread actual harm that is not immediate jeopardy.

As a general rule, in this forum, a facility may not challenge the level of a deficiency determination made by CMS. However, an exception to that rule is where a determination of substandard quality of care is made which results in loss of NATCEP authorization. 42 C.F.R. � 498.3(b)(14)(ii).

Here, the prima facie evidence supports CMS's determination that Petitioner's deficiencies showed a substandard quality of care involving actual harm under 42 C.F.R. � 483.25(c) (either the avoidable development or worsening of residents' pressure sores, as discussed above) that was at least widespread in the sense that the harm involved more than one resident. Petitioner has not successfully rebutted that evidence. Petitioner's loss of NATCEP is thus authorized by law.

V. Conclusion

I conclude that CMS correctly determined that Petitioner was not complying with federal participation requirements and that its noncompliance constituted substandard quality of care. I further find that CMS was authorized to withdraw approval of Petitioner's NATCEP for a period of two years, commencing March 14, 2002.

Jos� A. Anglada

Administrative Law Judge

1. I refer to these programs hereafter as NATCEP.

2. A closed record means that at the time of the survey the resident in question no longer resided in the facility.

3. Throughout the decision I may also describe a pressure sore as an ulcer, decubitus, or wound.

4. On February 15, 2002, Dr. McCartney addressed a letter to whom it may concern, wherein he indicated that scheduled turning was part of R7's care plan. P. Ex. 31.

5. The National Pressure Ulcer Advisory Panel (NPUAP) created a process for evaluating pressure sores based on a staging system from Stage I (earliest signs) to Stage IV (worst):

Stage I: A reddened area on the skin that, when pressed, is "non-blanchable" (does not turn white). This indicates that a pressure sore is starting to develop.

Stage II: The skin blisters or forms an open sore. The area around the sore may be red and irritated.

Stage III: The skin breakdown now looks like a crater where there is damage to the tissue below the skin.

Stage IV: The pressure ulcer has become so deep that there is damage to the muscle and bone, and sometimes tendons and joints.

See CMS Ex. 26.

6. CNA #2 acknowledged that R7 was not repositioned or toileted for over 21/2 hours on January 11, 2002. CMS Ex. 1, at 51.

7. It is puzzling that the nurse told the surveyor in the same meeting that he did not notify the physician, nor did he stage or measure the wound, because he did not believe it was caused by pressure.

8. When the resident was taken to the hospital in September, 2001, it was stated that she had a history of alcohol abuse and that she had stopped drinking 15 years earlier. On admission, no acute alcohol problem or intoxication were noted. P. Ex. 9, at 19.

9. In this case I have given the facility the benefit of the doubt regarding a worsening of R3's pressure sore because the sloppy documentation does not support a finding that it was in violation of 42 C.F.R. � 483.25(c)(2 ). Ordinarily, I would not reward a facility for its sloppiness.

10. From Petitioner's argument that weekly assessments are not a factor in early wound detection I draw the inference that, if Petitioner were truly honest about that assertion, it would have conducted assessments more frequently than weekly in order to more efficiently provide for the well-being of its residents. Such frequent assessments are not present in the record.

11. The distinction between an incidental finding by a CNA and a wound team skin assessment is significant. The former is based on a casual observation of certain portions of the resident's body, whereas the latter is based on a complete and thorough head to toe examination of the resident's entire body.

12. Petitioner argues that weekly skin assessments are unimportant in skin breakdown prevention, while arguing, at the same time, that the facility did in fact perform required skin assessments. P. Br. at 30.