SUBJECT:

Randolph County Care Center,

Petitioner,

Centers for Medicare & Medicaid

DECISION

Petitioner, Randolph County Care Center (Petitioner or Facility), is a long term care facility certified to participate in the Medicare and Medicaid programs as a provider of services. The Centers for Medicare & Medicaid Services (CMS) determined that Petitioner was not in substantial compliance with program participation requirements from March 30, 2000 through May 1, 2000. Petitioner appealed that determination. As explained below, I conclude that Petitioner was not in substantial compliance during that time period and uphold CMS's imposition of a Civil Money Penalty (CMP) of $300 per day.

I. Background

As a condition of participation in the Medicare and Medicaid programs, skilled nursing facilities (Medicare) and nursing facilities (Medicaid) periodically undergo surveys to determine whether they are in substantial compliance with program requirements. The Secretary of the Department of Health and Human Services (DHHS) contracts with state survey agencies to conduct those surveys. Social Security Act (Act), section 1864(a); 42 C.F.R. § 488.20.

Between March 27 and March 30, 2000, the Illinois Department of Public Health (State Agency) conducted an annual certification survey at Petitioner's facility and concluded that the Petitioner was not in substantial compliance with federal requirements for long term care facilities participating in Medicare and Medicaid. Petitioner requested and participated in an Informal Dispute Resolution proceeding and the State Agency subsequently deleted one deficiency and reduced the scope and severity level of another deficiency. Tr. at 271. The State Agency then issued a revised Statement of Deficiencies (SOD), setting forth the following alleged noncompliance: (1) tag F-314, 42 C.F.R. § 483.25(c)(2), for Petitioner's failure to ensure that two residents with pressure sores received necessary treatment and services to promote healing and prevent infection (scope and severity level of G - isolated instances causing actual harm); (2) tag F-324, 42 C.F.R. § 483.25(h)(2), for Petitioner's failure to ensure that a resident received adequate supervision and assistance devices to prevent accidents involving skin tears (scope and severity level of D, no actual harm with the potential for more than minimal harm); (3) tag F-444, 42 C.F.R. § 483.65(b)(3), for Petitioner's failure to ensure that its staff members wash their hands after each direct resident contact for which hand washing is indicated by accepted professional standards (scope and severity level of D). CMS Ex. 5.

On May 2, 2000, a revisit survey found Petitioner back in substantial compliance with participation requirements. CMS Exs. 6, 8. On May 22, 2000, CMS imposed a CMP of $300 per day from March 30, 2000 through May 1, 2000, for a total of $9,900, and indicated that Petitioner would lose its right to conduct nurse aide training and competency evaluation programs if, in the event Petitioner appealed, a CMP of $5,000 or more was upheld by final administrative decision. CMS Ex. 8.

On June 2, 2000, Petitioner requested a hearing before an Administrative Law Judge. CMS Ex. 9. The case was assigned to me. After exchanges of exhibits and prehearing briefing, a hearing was conducted in St. Louis, Missouri on February 4 and 5, 2003. At the hearing, I admitted CMS Exhibits (CMS Exs.) 1-11, 12A, and 13-22 and Petitioner Exhibits (P. Exs.) 1-41. After the hearing, CMS filed Centers for Medicare & Medicaid Services' Post Hearing Brief (CMS Br.), Petitioner filed Petitioner's Response to CMS' Post-Hearing Brief (P. Response), and CMS filed its Post Hearing Reply Brief (CMS Reply).

II. Issues

1. Whether, from March 30, 2000 through May 1, 2000, Petitioner was in substantial compliance with program participation requirements, specifically 42 C.F.R. § 483.25(c)(2), 42 C.F.R. § 483.25(h)(2), and 42 C.F.R. § 483.65(b)(3).

2. If Petitioner was not in substantial compliance, whether a CMP of $300 per day, for a total of $9,900, is reasonable.

III. Statutory and Regulatory Background

The Act sets forth requirements for nursing facility participation in the Medicare and Medicaid programs and authorizes the Secretary of DHHS to promulgate regulations implementing the statutory provisions. Act, sections 1819 and 1919. The Secretary's regulations governing long term care facility participation in these programs are found at 42 C.F.R. Part 483.

Long term care facilities must maintain substantial compliance with program requirements. Substantial compliance means that a facility's deficiencies may pose no greater risk to resident health and safety than "the potential for causing minimal harm." 42 C.F.R. § 488.301. State agencies, under agreement with CMS, monitor compliance with these participation requirements by conducting onsite inspections or surveys. 42 C.F.R. §§ 488.11, 488.330(a). A participating facility is subject to a standard survey at intervals of no less than 15 months (and on average at least once a year). 42 C.F.R. § 488.308.

Under the statute and "quality of care" regulation, each resident must receive and the facility must provide the necessary care and services to attain or maintain the highest practicable physical, mental, and psychological well-being, in accordance with the resident's comprehensive assessment and plan of care. Act, section 1819(b); 42 C.F.R. § 483.25. Accordingly, the facility must conduct an initial and periodic resident assessment of functional capacity. The assessment must be comprehensive, accurate, standardized, and reproducible. Based on the comprehensive assessment, the facility must ensure that a resident who enters the facility without pressure sores does not develop them unless the individual's clinical condition shows that they were unavoidable and that a resident having pressure sores receives treatment and services necessary to promote healing, prevent infection, and prevent new sores from developing. 42 C.F.R. § 483.25(c). Also, under the quality of care regulation, the facility must ensure that a resident receives adequate supervision and assistance devices to prevent accidents, here involving skin tears. 42 C.F.R. § 483.25(h)(2).

Under 42 C.F.R. § 483.65, a facility "must establish and maintain an infection control program designed to provide a safe, sanitary, and comfortable environment and to help prevent the development of and transmission of disease and infection." Petitioner was cited for violating subsection 483.65(b)(3), which provides that a facility must require "staff to wash their hands after each direct resident contact for which handwashing is indicated by accepted professional practice."

CMS bears the initial burden of producing evidence sufficient to establish a prima facie case for each alleged violation of the regulations. CMS must set forth the basis for its determination with sufficient specificity for a petitioner to respond and come forward with evidence related to the disputed findings. If CMS establishes a prima facie case, in order to prevail, the petitioner must then prove, by a preponderance of the evidence, that it was in substantial compliance with the relevant statutory and regulatory provisions. Meadow Wood Nursing Home, DAB No. 1841 (2002); Emerald Oaks, DAB No. 1800 (2001); Cross Creek Health Care Center, DAB No. 1665 (1998); Hillman Rehabilitation Center, DAB No. 1611 (1997), aff'd Hillman Rehabilitation Center v. U.S. Dept. of Health and Human Services, No. 98-3789 (D.N.J. 1999).

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

In setting the amount of the CMP, CMS considers: (1) the facility's history of noncompliance; (2) the facility's financial condition; (3) factors specified in 42 C.F.R.§ 488.404; and (4) the facility's degree of culpability, which includes neglect, indifference, or disregard for resident care, comfort, or safety. The absence of culpability is not a mitigating factor. 42 C.F.R. § 488.438(f). The factors in section 488.404 include (1) the scope and severity of the deficiency; (2) the relationship of the deficiency to other deficiencies resulting in noncompliance; and (3) the facility's prior history of noncompliance in general and specifically with reference to the cited deficiencies.

IV. Weight to be Given Witness Testimony

Petitioner argues that "this case should be won or lost based upon the credibility of the witnesses, their qualifications to render eyewitness, "expert," or "opinion" testimony, their knowledge of the subject matter upon which they testify, and the weight given by this Tribunal to such testimony." P. Response at 4. Petitioner assails the qualifications and credibility of CMS's three nurse witnesses on the grounds that two never worked as nurses in nursing homes, that their patient care experience was dated, that one had never treated pressure sores in any setting, that most of their knowledge of Petitioner's residents was based on record review, and that none of them had cared for a patient with a Stage IV pressure sore who had a hip prosthetic replacement. Id. at 5-7. Petitioner contrasted CMS's witnesses' experience with that of its own witnesses - nurses who had "hands-on nursing knowledge, and . . . knowledge of the facility's policies and its residents," particularly the residents at issue. Id. at 7.

I recognize that three of the four nurses who testified for Petitioner had many years of experience as nurses at Petitioner's facility and were closely familiar with the residents whose care is at issue. However, CMS's witnesses were registered nurses with four year nursing degrees and had both practical expertise and training in the specific areas they addressed. ⁽¹⁾ Therefore, I find them to be qualified to offer opinions in those specific areas. Additionally, I rely on the DHHS publication Pressure Ulcer Treatment Clinical Practice Guide (Practice Guide, CMS Ex. 19), Petitioner's acquiescence as to certain standards for the treatment of pressure sores (e.g., pressure sores require appropriate dressings and tissue offloading to promote healing), and Petitioner's failure to offer persuasive evidence as to why it could not follow the treatment standards more successfully than it did. Further, I decline to adopt some of CMS's assertions, such as staff should have used a "bridging" technique when providing care to R. 7, because I am not convinced that the witnesses' practical experience in dealing with such compromised patients warranted my adopting them.

V. Findings of Fact and Conclusions of Law ⁽²⁾

A. From March 30, 2000 through May 1, 2000, Petitioner was not in substantial compliance with program participation requirements set forth at 42 C.F.R. §§ 483.25(c)(2), 483.25(h)(2) and 483.65(b)(3).

1. Petitioner failed to ensure that residents having pressure sores received necessary treatment and services to promote healing, prevent infection, and prevent new sores from developing. 42 C.F.R. § 483.25(c)(2). For Resident 7 this failure resulted in actual harm; for Resident 13 this failure resulted in the potential for more than minimal harm.

Section 483.25 of 42 C.F.R. provides:

(c) Pressure Sores. Based on the comprehensive ass-essment 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 application of this regulation is well established by decisions by various panels of the Departmental Appeals Board (Board). Koester Pavilion, DAB No. 1750 (2000) and Cross Creek Health Care Center, DAB No. 1665 (1998) are leading decisions in this area. The Board has noted that the pressure sore regulation contains two distinct requirements: (1) a facility must ensure a resident who enters the facility without sores does not develop sores unless the resident's clinical condition demonstrates sores are unavoidable; and (2) a resident with pressure sores must receive necessary treatment and service to promote healing, prevent infection and prevent new sores. The Board has concluded in the area of pressure sores that a facility bears a duty to "go beyond merely what seems reasonable to, instead, always furnish what is necessary to prevent new sores unless clinically unavoidable, and to treat existing ones as needed." Koester Pavilion, DAB No. 1750, at 32; see also, Meadow Wood Nursing Home, DAB No. 1841 (2002) (loose dressing contaminated with fecal matter constitutes violation); Ridge Terrace, DAB No. 1834, at 15-16 (2002) (a single observation by a surveyor of a nurse aide cleaning an open sore area with a stool-stained washcloth was sufficient to sustain a deficiency finding under this tag). In this case, in order to establish a prima facie case, CMS must show either that Petitioner failed to provide necessary treatment and care to promote healing and prevent infection of a pressure sore or that a pressure sore became worse or infected, indicating that Petitioner did not provide necessary treatment and services to promote healing and prevent infection. If CMS makes a prima facie showing, Petitioner then bears the burden of showing that it took "all necessary precautions" in treating the pressures sore at issue. Crestview Parke Care Center, CR867, at 28 (2002), aff'd. DAB No. 1836 (2002).

CMS alleges that, for two of the three residents in the sample with pressure sores, Petitioner failed to provide necessary treatment and services to promote healing or prevent infection of pressures sores. CMS. Ex. 5, at 2. The two residents at issue are Resident 7 (R. 7) and Resident 13 (R. 13).

a. Care of R. 7

R. 7 was a 77-year-old woman who had lived at Petitioner's facility since 1994. Tr. at 451. R. 7 had diagnoses of Alzheimer's dementia, mitral valve prolapse, and degenerative osteoarthritis. On November 15, 1999, R. 7 was hospitalized with a fractured left hip sustained in a fall. She had hip replacement surgery and was transferred back to Petitioner's facility on November 26, 1999. CMS Ex. 5, at 5. Dislocation of R. 7's hip caused her to be rehospitalized from December 2 through 10, 1999. Tr. at 344. On December 27, 1999, R. 7 returned to the hospital because her hip was again dislocated. P. Ex. 16, at 8. R. 7 was in transit or at the hospital from 11:15 a.m. to 2:25 p.m. P. Ex. 16, at 9. Upon her return to Petitioner's facility, R. 7 had an open area on her coccyx which was 3 centimeters by 1.5 centimeters. P. Ex. 21. ⁽³⁾ A doctor's order for treatment was obtained on December 27, 1999. On January 14, 2000, the nursing notes stated that "Coccyx open area approx 3 cm x 2 cm with necrotic yellow tissue around edges, also has hard tissue around both outer edges. Sl odor noted." P. Ex. 16, at 34. By January 18, 2000, the sore was determined to be a Stage IV sore. ⁽⁴⁾ CMS Ex. 5, at 6. At the time of the survey, it remained a Stage IV sore. An entry dated March 17, 2000 in the Treatment Administration Record described the sore as follows:

Decub stage IV @ coccyx measures 7.8 cm length, 6.9 cm wide, 2.8 cm depth @ bottom near rectum, 1.5 cm depth @ top, tunnels 3.2 cm @ (L) side, tunnels 2.8 cm at Rt side at back, tunnels 4.2 cm @ Rt side near rectum, tunnels 6.8 cm @ Rt side in center Cont necrotic tissue & lg amt purulent foul smelling drainage.

CMS Ex. 16, at 2; CMS Ex. 5, at 9.

The sore failed to heal prior to R. 7's death in August 2000. Tr. at 283.

CMS asserts that Petitioner failed to provide necessary treatment and services to promote healing and prevent infection of R. 7's pressure sore. Specifically, CMS asserts that Petitioner's staff failed to properly position R. 7 to keep weight off her coccyx, improperly used a donut cushion, improperly cleaned the sore with Dakin's solution, and failed to provide adequate nutrition in a timely manner. CMS Ex. 5, at 4-13.

Petitioner responded that R. 7 presented many difficulties as a patient. Her physical condition was very debilitated. Tr. at 457. She was uncooperative and resistant to care because of her dementia. Tr. at 343, 348, 358, 429, 432, 434-435 and 459. Specifically, she resisted eating, was not always compliant about lying on her side, and pulled at her dressings. Id. R. 7 was required to wear an abductor pillow to prevent dislocation of her hips. Tr. at 349. She resisted wearing her abductor pillow and the pillow made positioning her more difficult. Petitioner asserts that it provided extensive care and services to R. 7 in an attempt to heal this pressure sore including an alternating pressure relief cushion, daily skin inspections, protocols for high risk skin breakdown and for infection control, A&D Ointment, infrared light, Polysporin, Santyl, Iodoform, an air flow mattress, nutritional supplements, vitamin C and zinc, and evaluations by two different wound care specialists. P. Response at 21. Petitioner concludes that "although it provided timely and necessary treatment to R7, her pressure sore worsened, due solely to R7's compromised, overall medical condition and non-compliance with her care." P. Response at 20.

While I recognize that R. 7 presented very difficult problems and than Petitioner's staff worked hard to help R. 7, I conclude that Petitioner failed to provide necessary treatment and services and this failure caused actual harm to R. 7. Below I discuss the elements of CMS's prima facie case and why Petitioner failed to prove by the preponderance of the evidence that it was in substantial compliance with § 483.25(c)(2).

Two reasons that led CMS to conclude that Petitioner failed to provide necessary treatment and services involve interventions that aggravate or interfere with the healing of pressure sores: first, Petitioner's use of a donut cushion in an attempt to relieve pressure at the site of the sore, and second, cleaning the sore with Dakin's solution. Petitioner implemented these interventions at the direction of R. 7's treating doctors. The donut cushion was ordered on February 16, 2000 and discontinued on February 28, 2000. P. Ex. 28, at 6-7. Cleaning twice daily with Dakin's was ordered on March 13. P. Ex. 28, at 11. ⁽⁵⁾

The surveyors testified that both donut cushions and cleaning with Dakin's solution are affirmatively harmful to pressure sores. A donut cushion is a round cushion with a hole in the center. Use of a donut cushion is harmful because the cushion increases the pressure on the circumference of the wound thereby interfering with the healing process. Tr. at 224. This conclusion is supported by the Practice Guide which provides "avoid donut type devices, which are more likely to cause pressure ulcers than to prevent them." ⁽⁶⁾ CMS Ex. 19, at 13. Dakin's solution is an antiseptic cleansing solution. Tr. at 223. The surveyors testified it should not be used to clean pressure sores because, while it kills germs, it also kills healthy and rejuvenating cells. Id. This conclusion is supported by the Practice Guide which provides, "Do not clean ulcer wounds with . . . antiseptic agents (e.g, . . . Dakin's solution . . .) because they are cytotoxic." ⁽⁷⁾ Id. at 15. Petitioner does not assert that using the donut cushion or Dakin's solution were appropriate treatment strategies for R. 7's pressure sore. Further, because this publication had been distributed in January 2000 to Petitioner's staff at an in-service training on pressure sores, staff had reason to know that the donut cushion and Dakin's solution were harmful. P. Ex. 24; Tr. at 90, 403.

Petitioner protests that the donut cushion and the Dakin's solution were ordered by R. 7's treating physician and that the donut cushion was discontinued after staff reported to the doctor that it was not helping. P. Ex. 28; Tr. at 134, 413; P. Response at 35. Petitioner argues that it should not be held responsible for these interventions because, as Petitioner's Assistant Director of Nursing testified, Petitioner's nurses have a responsibility to follow doctors' orders for treatment, medication and devices for its residents. Tr. at 453. I agree that this is the general rule. However, a long term care facility also has an "independent obligation [under § 1819(b)(2) of the Act] to plan for and provide services to meet the medical needs of each resident to help each resident maintain the highest practicable physical well-being." Beverly Health & Rehabilitation Center - Springhill, DAB No. 1696, at 44 (1999). Thus, the Board has held a long term care facility has "no regulatory obligation . . . to challenge a treatment order that [is] not on its face inappropriate for the diagnosis." Id. Conversely, where a doctor's treatment order is inappropriate "on its face" for the diagnosis, a facility does have an obligation to question the order. This was such a case. ⁽⁸⁾ The diagnosis of a pressure sore was unambiguous, and use of a donut cushion and Dakin's solution were known to be affirmatively harmful interventions for pressure sores. Staff should have known of this obvious risk of harm after its in-service on pressure sores, and staff should have questioned these orders when they were issued. Failure to do so and the use of the cushion and Dakin's solution constituted failure to provide necessary treatment and services to R. 7.

Additionally, CMS asserts that Petitioner failed to properly position R. 7 to ensure that her weight was off her coccyx and the pressure sore, and that in failing to properly position R. 7, Petitioner's staff failed to comply with R. 7's care plan. R. 7's care plan provided "turn from side to side (not on back)," "do not get up until ½ hr before meals and put back to bed within ½ hr after meals," and "position off of area as much as she will comply." CMS Ex. 16, at 5-6.

CMS's allegations of improper positioning are based on the observations of Surveyor T. At the hearing, Surveyor T. confirmed that the following observations she recorded in the SOD were correct. Tr. at 69-72.

On 3/28/00, at 9AM, R7 was observed lying on her back in bed, with the abductor in place between legs. At 9:10AM, a Certified Nurse Aide (CNA), took R7's breakfast tray to R7's room, and raised the head of the bed 70-80 degrees. The CNA then started to feed R7 the pureed diet. R7 was still being fed at 9:25AM. The CNA brought R7's tray out of R7's room at 9:35AM. R7 was positioned slightly to her right with the head of the bed elevated about 5 degrees. A wedge positioning device on R7's left side of the bed from waist level to above the shoulders. A pillow was on the right side of the bed between the bedrail and R7. R7 was not positioned off the stage IV pressure sore. R7 remained in the same position at 9:45. At 9:56, a nurse was observed giving R7 a supplement, with the head of the bed elevated about 10 degrees. R7 remained on her back, only slightly to the right, at 10AM, when the nurse left room, 10:15AM, 10:30AM, and 10:50 AM. At 10:52AM, 2 CNA's repositioned R7 onto her left side in bed. R7 was observed in a reclining gerichair with legs elevated, in the 200 hall near tub room at 11:45AM. The CNA stated R7 was to get a tub bath. R7 was observed at 12:33PM, same date of 3/28/00, in the 200 hall dining room. R7 was sitting in the gerichair and had not been fed yet. Observation was terminated at 12:35PM. The facility failed to position R7 off her pressure sore after feeding her breakfast and during the AM on 3/28,00, until 10:52AM. R7 was then in the reclining gerichair at 11:45[A]M and 12:35PM, at which time R7 had not been fed lunch yet. R7 was positioned on her pressure sore while in the gerichair.

On 3/29/00, R7 was observed lying on her left side in bed with the abductor in place, at 9:02AM. A CNA started feeding R7 in bed at 9:11AM. R7 was on her back with head of the bed elevated about 70 degrees. R7 was observed being fed at 9:20AM and 9:30AM. The CNA brought R7's tray out of the room at 9:37AM. R7 remained on her back with head of bed at same elevation, at 9:37AM, 9:56AM, 10:10AM at which time the nurse was observed giving R7 a supplement, 10:15AM, 10:25AM, 10:35AM, and 10:50AM. At 11AM, a CNA was observed giving R7 a bed bath. The head of the bed was flat and R7 was on her back. The CNA stated she had started the bath about 3-4 minutes prior to 11AM. At 11:15AM through 11:42AM, the CNA was observed administering Passive Range Motion to R7s right extremities, while R7 was on her back in bed. At 11:56AM, a CNA pushed R7 per gerichair, into the 200 hall dining room. R7 remained in the gerichair, and was completing being fed liquids at 12:52PM. Catheter care was observed at 2:05 on 3/9/00. The CNA state staff had transferred R7 back to bed at 1:15PM.

CMS Ex. 5, at 10-12.

Thus, on March 28 from 9:00 a.m. to 10:52 a.m., Surveyor T. repeatedly observed R. 7 lying on her back with pressure on her coccyx. During some portion of this time R. 7 was being fed and had to be on her back, but the majority of these two hours R. 7 should have been positioned off her coccyx. For approximately an hour and a half after 10:52, R. 7 was in a gerichair so the weight remained on her coccyx. Though R. 7 was tilted back to 70 or 80 degrees in the gerichair and sitting on a foam pressure relief cushion, this positioning and cushion would not "completely alleviate" the pressure on her coccyx. Tr. 70-71. When the surveyor terminated her observation at 12:35 p.m., R. 7 had still not been fed lunch so would remain in the gerichair after that time with pressure on her coccyx.

On March 29 from 9:37 to 10:50, Surveyor T. repeatedly observed R. 7 positioned on her back and coccyx. At 10:10, R. 7 was being given a dietary supplement, but after this was concluded she was left on her back. Except for the time she was drinking the supplement, R. 7 should have been turned off her coccyx. At 11:00 a.m., R. 7 was still on her back receiving a bed bath; at 11:15 through 11:42, she was on her back receiving passive range motion exercises. From 11:56 a.m. until 1:15 p.m. she was placed in the gerichair. Thus, from 9:37 to 1:15 that day, R. 7 was positioned on her coccyx. At the observation at 2:05, she was back on her back on her coccyx receiving catheter care. Again, some events over the morning, such as feeding and catheter care, required staff to position R. 7 on her back, but the dominant impression the surveyor's observations give is that staff was not diligent about positioning R. 7 off her coccyx as much as possible.

Pressure sores are ischemic ulcers, i.e., ulcers caused by the restriction of blood flow to the tissue. State Operations Manual (SOM), App. P. at PP-93. The Practice Guide states that relieving pressure sores of pressure through tissue load management "enhances soft tissue viability and promotes health of the pressure ulcer(s)." CMS Ex. 19, at 7. The necessity of keeping pressure off a pressure sore to facilitate healing is well recognized. Id. Surveyor T. testified that her major concern about R. 7's treatment was staff's failure to properly position R. 7 off her coccyx. Tr. at 68, see also 216. She concluded that staff's failure to position R. 7 off her coccyx as much as possible contributed to the worsening of her pressure sore and its failure to heal. Tr. at 77, see also 218, 225.

Petitioner does not dispute CMS's assertion that relieving the sore of pressure was necessary to promote healing. Rather, Petitioner responded that staff testified they did position R. 7 off her coccyx as much as possible. Tr. at 358, 373, 381-382, 391, and 399. Additionally, Petitioner cited to entries in nursing notes indicating that R. 7 was turned. Finally, Petitioner asserts that R. 7 was resistant to the hip abductor and to being positioned on her side. Tr. at 459. Petitioner does not directly challenge Surveyor T.'s observations about R. 7's positioning on March 28 and 29 except to point out that her observation was not continuous and that there were times that she observed R. 7 properly positioned. P. Response at 33-34.

For the following reasons, I do not find Petitioner's evidence about positioning persuasive.

• First, the fact that Petitioner's witnesses represented that R. 7 was positioned off her coccyx as much as possible is small comfort in relation to Surveyor T.'s observations of staff's positioning practices. Surveyor T.'s observations show that staff was not diligent about getting R. 7 off her coccyx while being observed by a surveyor. If they were not sufficiently diligent under observation, it is hard to believe that they were more diligent when not being observed.

• Second, Surveyor T. testified she saw R. 7 positioned properly several times and that R. 7 did not appear to be resistant to being positioned on her side. Tr. 72-73. Further, even if R. 7 were resistant, staff was still obligated to keep trying to get her off her coccyx so the sore could heal. Finally, Petitioner offered no descriptive testimony as to staff's attempts to address R. 7's reputed resistance which would enable to me to find that staff, in fact, had taken "all necessary precautions" to position R. 13 correctly. Koester Pavilion, DAB No. 1750, at 32.
  

• Third, the fact the surveyor's observations were not continuous does not diminish their persuasiveness. The surveyor was quite diligent, returning at intervals of 10 and 15 minutes. Petitioner offered no evidence to indicate that between those intervals staff was positioning R. 7 correctly and then repositioning her incorrectly just in time for the surveyor's next observation.

CMS also alleged that Petitioner did not provide timely nutritional support to R. 7 and this failure contributed to the failure of the pressure sore to improve. Because I find that Petitioner failed to provide necessary treatment and services by using a donut cushion and Dakin's solution and by not positioning R. 7 properly, I do not reach the question of whether Petitioner failed to provide timely nutritional support.

Finally, I conclude that Petitioner's failure to provide necessary treatment and services caused actual harm. On December 27, 1999, R. 7 had what Petitioner described as a wound caused by her being transferred between a number of surfaces when she was transported to the hospital, x-rayed, and transported back to the nursing home. Tr. at 352. On December 27, Petitioner's staff did not even stage this wound as a pressure sore. P. Ex. 21. Between December 27, 1999 and January 19, 2000, the wound became a Stage IV pressure sore. By March 2000, it was 7.8 centimeters long, 6.9 centimeters wide, and 2.8 centimeters deep with exposed muscle tissue and bone. Petitioner failed to show that its use of a donut cushion and Dakin's solution and its failure to position R. 7 properly did not contribute to the worsening of this sore or to its failure to improve.

b. Care of R. 13

R. 13 was admitted to Petitioner's facility from a hospital three days prior to the start of the survey. CMS Ex. 5, at 2. At the time of her admission, R. 13 had a Stage III pressure sore on her coccyx. Id.

CMS asserts that Petitioner was not in substantial compliance with § 483.25(c)(2) because a Stage III pressure sore requires treatment and staff did not obtain a doctor's order for treatment until Monday, three days after admission. CMS also asserts Petitioner was not in compliance because staff failed to identify scabbed areas on R. 13's left ankle, great toe and second toe in the Admission Skin Assessment (P. Ex. 11).

As to the coccyx pressure sore, Petitioner argues that it did make appropriate attempts to get a doctor's order for treatment and that, pending its obtaining a doctor's order, staff provided necessary treatment and services to promote healing and prevent infection by following its Interim Skin Care Policy. P. Response at 16. As to the scabbed areas, Petitioner argues that they were not pressure sores, were therefore not treated as pressure sores, and did not need to be identified on the admission skin assessment. Id. at 17.

R. 13 was admitted to Petitioner's facility from a hospital on Friday, March 24, 2000. R. 13's "Admission Skin Assessment" reported that R. 13 had a "4 cm bruise on back of the [left] knee/leg, 3 cm bruise on [left] upper arm, 1.5 cm bruise on the [right] outer elbow, 1.7 cm Stage III open area on coccyx, no other reddened or open areas." ⁽⁹⁾ P. Ex. 10. When R. 13 arrived at the facility, she had a Duoderm on the pressure sore on her coccyx and on a scabbed area of her outer left foot. ⁽¹⁰⁾ P. Ex. 8, at 5. In order to complete the Admission Skin Assessment, these Duoderms were removed. Tr. at 304.

The doctor's orders admitting R. 13 on March 24 contained no order for treatment of a coccyx pressure sore. Id. at 2-4. Petitioner asserts that, in the absence of an order, staff followed its "Interim Skin Care Policy" (P. Ex. 3) which was signed by its Medical Director. ⁽¹¹⁾ That policy provided -

When a Resident is identified to have a skin tear, pressure sore, or other open area (non-emergency), every effort is made to obtain, in a timely manner treatment orders/ primary physician.

In the interim, not to exceed 72 hours; keep areas:

1. Free from soiling.

2. Cleanse with soap and water PRN soiling.

3. Apply vaseline (as needed) to site to promote comfort and as a moisture barrier.

4. Gauze dressing if drainage present.

5. Keep body part free from pressure.

6. Observe and monitor every shift applying the above steps.

P. Ex. 3.

I conclude Petitioner failed to provide R. 13 with necessary treatment and services to promote healing and prevent infection of this pressure sore. For three days, Petitioner failed to obtain a doctor's treatment order for a Stage III pressure sore. Petitioner does not dispute that a doctor's order was needed for this resident. It argues it was in substantial compliance with § 483.25(c)(2) during the three days because it was following its Interim Skin Care Policy. I reject this argument. First, even if I assume that Petitioner's interim policy constituted substantial compliance, I find that staff did not actually follow its policy. Second, even if staff had followed its interim policy, I conclude that Petitioner failed to prove that its policy ensured that residents received necessary treatment and services to promote healing and prevent infection of pressure sores.

For the following reasons I find that Petitioner's staff did not follow its interim policy on Friday, Saturday and Sunday, March 24-26, 2000.

• First, Petitioner's Interim Skin Care Policy provided that "every effort is made to obtain, in a timely manner [,] treatment orders." P. Ex. 3. However, staff failed to make "every effort" to obtain a treatment order in a timely manner. R. 13 was admitted on Friday, March 24, 2000 with a Stage III pressure sore on her coccyx. On Friday, the nursing notes describe the sore but make no mention of any treatment or call(s) to her treating doctor. P. Ex. 4, at 1. On Saturday, the 3:00 p.m. entry states the sore was cleaned and Vaseline applied and a message was left on the doctor's answering machine about the sore. Id. at 2. On Sunday there is no mention in the notes of the sore or attempts to contact the doctor. Id. at 2-3. ⁽¹²⁾ The nursing notes should describe care provided to R. 13. ⁽¹³⁾ According to these notes, the doctor was not called on Friday; the doctor was called once on Saturday, and the doctor was not called on Sunday. ⁽¹⁴⁾ One call in three days to a doctor, who was known by staff to be unresponsive to calls (Tr. at 334), for a Stage III pressure sore does not ensure receipt of necessary treatment and services to promote healing and prevent infection.
  

• Nurse H.'s testimony that she called Dr. Preuss at least four times on Friday is not persuasive for the following reasons. ⁽¹⁵⁾ At 5:00 p.m. on Friday, Nurse H., who described herself as very thorough in making notes (Tr. at 297), wrote more than a half a page of notes describing many things about R. 13, including her sore. These notes made no mention of Nurse H.'s calling the doctor. P. Ex. 4, at 1. At 10:52 p.m., she made another entry into the notes but made no mention of the sore or of calling the doctor. Id. Unreturned calls to a doctor for a needed treatment order are obviously information about which subsequent shifts should be aware so that they can continue to pursue a treatment order. It is not credible that, having called a doctor for a treatment order at least four times in the preceding seven hours, a nurse would not record at least one of those calls in the nursing notes. ⁽¹⁶⁾ Additionally, Nurse H. testified that, as of March 2000, she had been an LPN and worked at this facility for about six months (Tr. at 289) and that she had not seen very many pressure sores. Id. at 317. Given this evidence, I find it more reasonable to conclude that Nurse H., as a relatively new nurse, did not realize on March 24 that she needed to call the doctor and did not do so.

• Second, the policy provided that the sore is to be cleaned and Vaseline applied as needed, and the body part kept free from pressure. Id. Petitioner's witness agreed that Vaseline would rub off and needed to be reapplied. Tr. at 324-325. The nursing notes do not support a finding that Vaseline was applied as needed. Rather, the notes reflect only one application of Vaseline, occurring on Saturday. Even assuming Nurse H. applied Vaseline, as she testified, on removing the Duoderm on Friday, two applications of Vaseline over Friday, Saturday, and Sunday on an area that is necessarily in contact with chairs and beds hardly seems adequate to maintain a "moisture barrier." Further, the nursing notes reflect no efforts to keep pressure off the coccyx until the entry at 10:00 a.m. on Monday the 27^th. ⁽¹⁷⁾


• Third, the policy provided that the staff is to "observe and monitor every shift applying the above steps." Id. There is nothing in the nursing notes to indicate that each shift "observ[ed] and monitor[ed] . . . applying the above steps." In fact, there is nothing in the nursing notes that would indicate the nurses, prior to the nurse who made the 10:00 a.m. entry on Monday, understood they were applying the Interim Skin Care Policy. ⁽¹⁸⁾

Further, I conclude that, even if Petitioner staff did comply with its Interim Skin Care Policy, Petitioner failed to show that the policy provided "necessary treatment and services to promote healing, [and] prevent infection" of a Stage III pressure sore.

CMS witnesses testified that a Stage III pressure sore is a serious pressure sore which must be treated in order to promote healing, prevent infection and prevent progression of the sore to Stage IV. Tr. 152, 157, 226-227. The Practice Guide specifically provides that -

[p]ressure ulcers require dressing to maintain their physiologic integrity. An ideal dressing should protect the wound, be biocompatible, and provide ideal hydration. . . . The cardinal rule is to keep the ulcer tissue moist and the surround intact skin dry.

CMS Ex. 19, at 11.

Petitioner's witnesses did not deny any of these assertions.

CMS witnesses testified (1) that Vaseline did not constitute a dressing which would promote healing, prevent infection or keep the wound bed of a Stage III sore moist and (2) that any reputed beneficial properties of Vaseline are diminished by the fact that it easily it rubs off. Tr. at 152, 157, 227. They contrasted the properties of Vaseline with those of a Duoderm which keeps the wound bed moist, promotes healing, prevents infection, and remains on the sore. Id. at 152. One of the CMS witnesses testified that she had never heard of Vaseline being used on a wound bed for these purposes. Id. at 178.

In response, one of Petitioner's nurses testified she had used Vaseline over nine and a half years on interim basis for pressure sores and not experience infections. Tr. at 334. A second nurse testified that use of Vaseline was acceptable nursing practice and that it protected wounds from contamination. Tr. at 420. Additionally, Petitioner pointed out that the use of Vaseline was approved by its medical director. Petitioner's witness did acknowledge that Vaseline rubbed off and had to be reapplied. Tr. at 324-325.

I conclude that Petitioner failed to show its Interim Skin Care Policy, particularly the use of Vaseline as a dressing, constitutes "necessary treatment and services to promote healing, [and] prevent infection" of a Stage III pressure sore. Petitioner did not deny that Stage III pressure sores are serious sores which require appropriate dressings to promote healing and to prevent infection. Petitioner introduced no evidence which would tend to show that Vaseline promotes the healing of pressure sores. ⁽¹⁹⁾ As to prevention of infection, the testimony of two of Petitioner's nurses is not adequate to establish that Vaseline effectively prevents infection in pressure sores. Generally, nurses are not qualified to testify to standards of medical treatment, nor was there testimony sufficient for me to find that Petitioner has developed and tested an effective alternative to those measures generally recognized as appropriate for prevention of infection of pressure sores. In fact, while the product's manufacturer represents that Vaseline® "offers soothing protection for minor burns" (and even that "used regularly, reduces the appearance of fine lines and wrinkles"), the manufacturer makes no claims as to infection control or as to the efficacy of its use for serious wounds. See http://www.vaseline.com/vpjpure.shtml. Further, the fact that the interim policy was signed by Petitioner's medical director is not sufficient. The medical director did not testify to explain his expert opinion as to the appropriateness of using Vaseline with a Stage III pressure sore for three days. Finally, the fact that the treating physician ultimately ordered the application of a Duoderm, the treatment used in the hospital, also tends to show that Vaseline was not the treatment of choice for a pressure sore. Rather, Vaseline was plainly used, just a the policy said, as an interim measure, pending implementation of a strategy which would constitute "necessary treatment and services to promote healing, [and] prevent infection" of a Stage III pressure sore. The standard for care of pressure sores is high. A facility must "take all necessary precautions" to promote healing and prevent infection. Koester Pavilion, DAB No. 1750, at 32. Three days' reliance on an interim strategy based on Vaseline for a Stage III pressure sore constitutes failure to take all necessary precautions.

Petitioner asserts that R. 13 suffered no harm as a result of its reliance on the Interim Skin Care Policy in that the sore did not become infected and eventually healed completely. P. Response at 17, Tr. 326, 324, 335, 422, 448. CMS is not required to show that a facility's care of a pressure sore cased actual harm. Ridge Terrace, DAB No. 1834 (2002). At the hearing, CMS offered persuasive evidence that Petitioner's care resulted in the potential for more than minimal harm because of the risk for infection and the risk the sore could progress to Stage IV. Petitioner did not address these assertions except by reliance on its Interim Skin Care Policy which I have found to have been inadequate. ⁽²⁰⁾ Therefore, I conclude that, at a minimum, Petitioner's care of R. 13's pressure sore created a risk for more than minimal harm and constituted substantial noncompliance with 42 C.F.R. § 483.25(c)(2).

CMS also asserted that staff's failure to identify on admission and treat certain scabbed areas on R. 13's feet and ankles constituted substantial noncompliance with section 483.25(c)(2). Because I have found Petitioner's care of R. 13's coccyx sore deficient, I do not need to address CMS's arguments as to the scabbed areas on her feet and ankles.

2. Petitioner failed to ensure that Resident 9 received adequate supervision to prevent accidents resulting in breaks to her skin. 42 C.F.R. § 483.25(h)(2). This failure resulted in the potential for more than minimal harm.

CMS alleged that Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(h)(2). This regulation provides that a "facility must ensure that . . . each resident receives adequate supervision and assistance devices to prevent accidents."

This alleged deficiency involves care provided to Resident 9 (R. 9). R. 9 was an elderly resident who was cognitively impaired and required a two-person transfer. Tr. at 159. CMS argued that Petitioner failed to ensure that R. 9 received adequate supervision during transfers and failed to investigate a series of skin breaks suffered by R. 9 in order to prevent accidental damage to her skin in the future. CMS Br. at 21.

In support of its finding, CMS relied on the following facts occurring over a thirty-day period.

• On February 23, 2000, R. 9 sustained a 1 cm flap, circle skin tear to her right shin during transfer P. Ex. 39, at 7. Petitioner completed a "Skin Tear/Bruise Occurrence Report" in which it identified the injury and concluded it occurred in the tub room with a identified CNA. The Director of Nurses (DON) wrote "Staff reminded to perform cautious safe transfers - remove foot pedals of w/c." Id. at 9.

• On February 25, 2000 an Accident or Incident Report stated that R. 9 had an "open area to lt heel of foot. Area appox 2 ½ cm round, irregular edges - yellowish-while center. Area pink around edges. [no] drainage noted. POA - Thelma Lord notified." P. Ex. 39, at 5. On the report, the DON wrote "Encourage staff to reposition frequently and q2hrs minimally." Id. at 6. There was no indication as to what caused the open area, or whether it was an injury or a pressure area. CMS Ex. 5, at 14.

• In nursing notes dated February 25, 2000, a nurse indicated that R. 9 also had an abrasion on her left calf but there was no indication how it happened. CMS Ex. 5, at 14.

• On February 29, 2000, an Accident or Incident Report stated that R. 9 had a .5 cm/dm reddened area on the top of her left forearm. The DON's entry on the report indicated that the area was of "unknown etiology - suspect is positioning of arms R/T new left sided weakness." P. Ex. 39, at 4. There was no indication there had been any investigation to determine what had actually happened to R. 9's arm or that staff had been advised as to a position problem. CMS Ex. 5, at 14.

• On March 1, 2000, an Accident or Incident Report stated that R. 9 had an "old scabbed area rt ankle, outer aspect, 1 cm in size, round, surround tissue red. Noted sm. indentation in center, no drainage noted, Stage II." P. Ex. 39, at 10. There was no documentation about how the area might have opened. CMS Ex. 5, at 14.

• On March 23, 2000, a Skin Tear/Bruise Occurrence Report stated that R. 9 had a "1 cm [skin tear] to back of left calf, approximately 1 cm x 0.5 cm . . . [and] 0.2 scraped area to [left] heal, outer aspect." P. Ex. 39, at 1. The DON's note on the report indicated "staff education ongoing re/transfers [and] resident safety." P. Ex. 39, at 3. There was no documentation as to how the skin tear or scrape occurred or what was entailed in ongoing staff education. CMS Ex. 5, at 15.

• In an interview with the DON, Surveyor W. determined that "no further investigations were done to determine cause of injury, when resident was last seen without the injury/open area, what was being done to prevent future accidents/incidents or what action was taken to ensure direct care staff did not repeat same procedure and cause more injuries." CMS Ex. 5, at 15.

Surveyor H. testified that frequent skin tears are avoidable with adequate investigation and proper followup and supervision. Tr. at 229. Two surveyors testified that failure to properly investigate the injuries created the potential for more than minimal harm because such failure increased the risk of additional skin tears or more severe injuries. Tr. at 162, 229.

Based on this evidence, I conclude that CMS made a prima facie case that Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(h)(2). R. 9 had obvious skin integrity problems. The pattern of skin injuries between February 23 and March 23, the lack of inquiry as to the source of the injuries, and the lack of consideration as to how to prevent future skin injuries support CMS's conclusion that Petitioner was not providing "adequate supervision and assistance devices to prevent accidents." This conclusion is supported further by R. 9's plan of care. Problem 1 of her plan of care is described as "potential for infection related to disrupted skin integrity." P. Ex. 38, at 1. The goal for the problem was described as "skin will heal without complication." Id. Absent from this plan is any indication that Petitioner was affirmatively trying to prevent "disrupted skin integrity" by ensuring that R. 9 received adequate supervision or assistance devices to prevent skin injuries. The failure to investigate R. 9's skin tears and to plan for preventing additional skin injuries posed a greater risk to R. 9's health and safety than the potential for causing minimal harm and constituted substantial noncompliance with 42 C.F.R. § 483.25(h)(2).

Petitioner did not introduce any persuasive evidence or arguments to show that it was in substantial compliance with 42 C.F.R. § 483.25(h)(2). The Assistant Director of Nurses (ADON) testified as follows:

If a skin tear was noted by - usually it's one of the CNA's caring directly for them -- they would report it to the nurse. She would notify the doctor and get a treatment order. And they made out reports and it came to our - our office. And we usually investigated to try to determine what caused it.

Tr. at 460.

The ADON testified further that she usually reviewed the reports and put them in the care plan. Id. at 463. She said the reason such reports are put in the care plan is "to help identify the problems and implement intervention to [prevent future reoccurrences]." Id at 464. These described actions, i.e., identifying problems and implementing interventions, are exactly what a facility should be doing to prevent future accidents. However, the deficiency was based on the fact that staff did not do appropriate investigations to determine why R. 9 skin integrity was repeatedly compromised in a 30-day period or implement interventions to prevent accidental future skin tears based on such investigations.

3. Petitioner failed to maintain an infection control program designed to provide a safe, sanitary, and comfortable environment and to help prevent the development of and transmission of disease and infection and failed to require staff to wash their hands after each direct resident contact for which handwashing is indicated by accepted professional practice. 42 C.F.R. § 483.65(b)(3). This failure resulted in the potential for more than minimal harm.

CMS asserts that Petitioner was not in substantial compliance with 42 C.F.R. § 483.65(b)(3) which provides -

The facility must require staff to wash their hands after each direct resident contact for which handwashing is indicated by accepted professional practice.

This subsection is part of a regulation dealing with infection control the introduction of which provides -

The facility must establish and maintain an infection control program designed to provide a safe, sanitary, and comfortable environment and to help prevent the development of and transmission of disease and infection.

Based on a surveyor's observation of a nurse's conduct in changing the dressing on R. 7's pressure sore, CMS asserts that Petitioner failed to comply with this regulation. The SOD alleges as follows: the surveyor watched a nurse administer care to R. 7's pressure sore, including removing bandages, removing dressings which were "saturated with greyish/tannish foul smelling drainage," irrigating the sore, packing the sore, and applying new outer dressings and tape. Between each step of care, the nurse removed her gloves and cleaned her hands with a bottle of anti-microbial alcohol gel. R. 7's room did not have a sink in it. CMS Ex. 5, at 15-18; Tr. at 93-95.

CMS maintained that the nurse's failure to wash her hands with soap and water after touching the dressings with drainage violated section 483.65(b)(3). CMS Ex. 5, at 17; Tr. at 230. CMS cited the Practice Guide which states that "[o]nce the hands of the caregiver are soiled with secretions, they should not come in contact with the remaining clean dressings or other supplies until the gloves are removed and the hands are washed." CMS Ex. 19, at 21. However, the surveyor did not explain how the nurse was to wash her hands with soap and water in a room which did not have sink, nor did CMS assert that participation requirements required a sink in the room or R. 7 to be in a room with a sink. ⁽²¹⁾ In the SOD, the surveyor stated that the nurse's use of anti-microbial gel to clean her hands did not replace the need for the nurse to wash her hands. CMS Ex. 5, at 17. Notwithstanding this assertion, Surveyor H. testified that, absent access to a sink, such a alcohol gel was the next best way to clean hands. Tr. at 251. Given this less-than-complete explanation of how the nurse should have proceeded in a room without a sink and the conflicting statement of the CMS witness, I conclude that CMS failed to establish a prima facie case that the nurse's use of anti-microbial alcohol gel in a room without a sink between glove changes constituted substantial noncompliance with section 483.65(b)(3).

CMS alleged that other actions by the nurse constitute substantial noncompliance with section 483.65 and subsection 483.65(b)(3). The surveyor observed the nurse, after removing her gloves but prior to cleaning her hands, touch the handle of the treatment cart drawer and use her bare hands to pick up the bottle of gel. She then put the bottle back in the treatment cart drawer. CMS Ex. 5, at 16-17. The surveyor also observed the nurse put the box of gloves on the bottom sheet of R. 7's bed and then back into the treatment cart drawer containing R. 7's clean dressings and other residents' supplies. CMS Ex. 5, at 18. The surveyor asserted that these actions risked contaminating the treatment cart drawer handle and interior, the box of gloves, the bottle of gel, R. 7's clean dressings, and other residents' supplies in that drawer. Tr. at 94-95. The surveyor concluded that contamination could result in the spread of infection and would pose a greater risk to resident health and safety than the potential for causing minimal harm. Id.

Petitioner offered no persuasive arguments or evidence as to why the nurse's actions did not create a risk of contaminating the treatment cart and its contents or why such contamination did not create a risk for spreading infection. Instead, Petitioner questioned the surveyors as to whether they saw holes in the gloves. Tr. at 137, 251. However, as the CMS witnesses testified, intact gloves do not guarantee that hands are fully protected from contaminating bacteria. Tr. at 230. This testimony is supported by the fact that the Practice Guide recommends washing hands after removing gloves. CMS. Ex. 19, at 20-21. Petitioner introduced no evidence to the contrary. Therefore, the fact that no one saw holes in the gloves does not prove that the nurse should not have cleaned her hands. Additionally, Petitioner questioned the CMS witnesses about Petitioner's infection control rates and whether R. 7's sore had resulted in additional infections. Tr. at 137, 252. However, this evidence is not relevant to whether the nurse's handling of the box, bottle and drawer was consistent with accepted professional standards for handwashing and infection control. CMS does not have to show that these actions resulted in actual harm, only that they had the potential for causing more than minimal harm. Lake City Extended Care Center, DAB No. 1658 (1998).

I conclude CMS made a prima facie case that the nurse's actions were not consistent with accepted professional practice for handwashing or with "an infection control program designed to provide a safe, sanitary, and comfortable environment and to help prevent the development of and transmission of disease and infection" and could result in more than minimal harm. For the reason discussed above, Petitioner did not prove substantial compliance with 42 C.F.R. § 483.65 or 483.65(b)(3).

B. Petitioner has offered no arguments as to why the amount of the CMP imposed, $300 per day, is unreasonable and I see no basis in the record for concluding it is unreasonable.

In reaching a decision on the reasonableness of the CMP, I apply the factors listed in 42 C.F.R. § 488.438(f). My "inquiry should be whether the evidence presented on the record concerning the relevant regulatory factors supports a finding that the amount of the CMP is at a level reasonably related to an effort to produce corrective action by a provider with the kind of deficiencies found and in light of the other factors involved." CarePlex of Silver Spring, DAB No. 1683, at 8.

For the following reasons, I uphold CMS's imposition of a $300 per day CMP. The deficiencies cited were not insignificant; one of them caused actual harm to a resident. The 1999 cycle of compliance surveys resulted in four G level (actual harm) citations, one of which was for 42 C.F.R. § 388.25(c) (pressure sores). CMS Ex. 13, at 1. Three hundred dollars per day is at the lower end of the mandatory range ($50 to $3,000) for non-immediate jeopardy citations. Petitioner offered no arguments, other than challenging the presence of the deficiencies, as to why $300 per day is not in accord with the regulatory factors. Additionally, Petitioner did not argue that the total of the CMP should be lower on the grounds that it returned to substantial compliance prior to May 1, 2000.

VI. Conclusion

For all of the reasons discussed above, I uphold CMS' determination that, from March 30, 2000 through May 1, 2000, Petitioner was not in substantial compliance with program participation requirements, specifically 42 C.F.R. §§ 483.25(c)(2), 483.25(h)(2) and 483.65(b)(3). The amount of the CMP imposed, $300 per day, is reasonable.

Richard J. Smith

Administrative Law Judge

1. Surveyor T. worked as a long term care facilities surveyor for the State Agency from 1991 to 2002. Tr. at 54. She has a bachelor of science degree and has been a registered nurse since 1966. Id. Prior to 1991, she worked as a nurse in hospitals and mental health institutions. Id. at 56. In these jobs she worked with patients who were are at risk for developing pressure sores and had pressure sores. Id. at 57-58. As a surveyor, she has attended multiple training sessions on prevention and care of pressure sores and on nutrition. Id. at 57. Surveyor T testified about R.7.

Surveyor W. had been employed by the State Agency for 1998 as a Health Facility Surveillance Nurse. Tr. at 145-146. She has an Associates Degree in Nursing and became a registered nurse in 1993. Id. at 146. Prior to 1998, she worked as a psychiatric nurse in various hospitals. Id. She has had training, both in nursing school and in her capacity as a surveyor, in the prevention and care of pressure sores. Id. at 146-147. Surveyor W testified about R. 9 and R. 13.

Surveyor H. is an employee of CMS. She did not participate in the on-site survey but based her opinions on the documentary evidence. Surveyor H. started working for CMS in 1995. She has an associates degrees in nursing and science (1984) and a bachelor of science degree in nursing (1987). Tr. 211. She has been a registered nurse since 1984 and received a certificate in rehabilitation nursing in 1992. Id. She has had training in the prevention and care of pressure sores, nutrition, and infection control. Id. at 212-214. Prior to 1995, her primary jobs were with nursing homes and long term care catastrophic hospitals, during which time she spent some 11 years at long term care institutions. Id. at 213. In these jobs, she cared for patients at risk of pressure sores and who had pressure sores. Id. at 213-214. Her current position with CMS is Nurse Consultant/Health Quality Review Specialist. Id. at 210. Her duties include overseeing state survey agencies and participating as an on-sight overseer in 5 per cent of surveys conducted by a state survey agency. Id. at 210-211. Surveyor H. testified about R. 7, R. 9 and R. 13.

2. I make Findings of Fact and Conclusions of Law (Findings) to support my decision in this case. I set forth each Finding as a separately numbered heading, and explain each Finding in detail.

3. Surveyor H. testified that she believed the open area started developing prior to December 27, 1999 (Tr. at 215-216) and counsel for CMS cross-examined Petitioner's witness about whether R. 7 had the open area prior to the trip (Tr. at 464-465). However, I decline to address the question of whether R. 7's pressure sore developed prior to December 27, 1999 because resolving the question would not make a material difference to this decision.

4. The State Operations Manual (SOM) describes a Stage IV pressure sore as a sore in which "[a] full thickness of skin and subcutaneous tissue is lost, exposing muscle and or bone." SOM App. P, at PP-93. Petitioner's weekly skin assessment form describes a Stage IV sore as a "[s]kin break with deep tissue involvement with necrotic tissue present." P. Ex. 11, at 1. In this case, both bone and muscle tissue were visible. CMS. Ex. 5, at 10.

5. It is not clear when the Dakin's cleaning was terminated. Surveyor T. testified it was being used on March 27, 2000 when she observed R. 7's treatment. Tr. at 133. R. 7's records indicate that it was used as late as March 29. P. Ex. 28, at 13.

6. The recommended citation for this Practice Guide is Bergstrom N, Bennett MA, Carlson CE, et al. Pressure Ulcer Treatment Clinical Practice Guideline,. Quick Reference Guide for Clinicians, No. 15. Rockville, MD: U.S. Department of Health and Human Services, Public Health Service, Agency for health Care Policy and Research, AHCPR Pub. No. 95-653. Dec. 1994. CMS. Ex. 19, at 3. It is also available on the Internet at http://www.ahcpr.gov/clinic/cpgonline.htm.

Petitioner sought to discredit this publication by arguing that it is "merely a reference guide, a recommendation, not the law that a facility must follow, not incorporated into the Code of Federal Regulations, and ultimately, up to a facility whether to accept or reject the recommendations." P. Response at 7, Tr. at 238. I reject Petitioner's argument. The Practice Guide was developed by a panel of doctors, nurses, and academicians using an "explicit, science-based methodology . . . along with expert clinical judgment to develop a specific statement on patient assessment, treatment and management of pressure ulcers." CMS Ex. 19, at 2. Thus, while the Practice Guide does not set forth "the law a facility must follow," it does set forth expert medical recommendations for the care of pressure sores. In this case, I rely on it for the recommendations that Dakin's solution and donut cushions are inappropriate treatment interventions for pressure sores, that positioning tissue load off sores promotes healing, and that appropriate dressings promote healing and prevent infection. Petitioner did not argue that these recommendations are incorrect, offer any evidence that would tend to show the recommendations are incorrect, or offer persuasive evidence as to how its divergence from these recommendations was also medically acceptable.

7. Cytotoxic mean "toxic to cells, cell-toxic, cell-killing." MedecineNet.com at http://www.medtenns.com.

8. Surveyor H. testified that Petitioner's staff should have questioned the doctors as to these orders. Tr. at 224. I reject Petitioner's assertions that the surveyor changed her position on cross examination. P. Response at 35 citing Tr. at 237. On cross the surveyor was simply agreeing with the general rule that a nurse must follow doctors' orders. She was not repudiating her prior opinion that the nurses should have first questioned the doctor. Also, I reject Petitioner's characterization of Surveyor H.'s testimony as agreeing that Petitioner had provided good nursing care by using the donut cushion and then reporting to the doctor that it was not helping. P. Response at 35 citing Tr. at 243-244.

9. A Stage III pressure sore is defined by the SOM as a sore in which "a full thickness of skin is lost, exposing the subcutaneous tissues - presents as a deep crater with or without undermining adjacent tissues." SOM, App. P at PP-93. Petitioner's 'weekly summary' form describes a Stage III sore as a "skin break with deep tissue involvement." P. Ex. 11, at 1.

10. A Duoderm is a "wound dressing. It's a gel like wafer and the outer part is water resistant and the inner part keeps the wound bed moist and promotes healing and prevents infection. . . .[It] is self-adhering and you can leave it one for three days . . . ." Tr. at 152.

11. The Interim Skin Care Policy was not dated. P. Ex. 3. Petitioner represented that it had been adopted the December preceding the March 2000 survey. Tr. at 263. The SOD does not mention the Interim Policy and the surveyor could not remember being shown the policy during the survey. Tr. at 177.

12. On Monday, the notes state that a nurse called Dr. Preuss at 10:00 a.m. and the 1:00 p.m. entry states that a nurse called Dr. Preuss about the sore. Id. at 3. At 1:00 p.m., the notes reflect the same nurse called Dr. Preuss again. The notes state that at 5:00 p.m. Dr. Preuss called with a treatment order. The 8:00 p.m. entry states that the order was implemented, i.e., a Duoderm was applied to the sore. Id.

13. The regulation at 42 C.F.R. § 483.75(l)(1) requires that a facility maintain clinical records on each resident in accordance with accepted professional standards and practices. The records must be complete, accurately documented, readily accessible and systematically organized.

14. Petitioner represented that staff did not call its Medical Director because he was out of town. Additionally, under the system it uses for obtaining on-call physicians, Dr. Preuss was the on-call physician for that weekend. Tr. 283.

15. Nurse H. testified as follows: at 3:45 p.m. on Friday, March 24, 2000, she admitted R. 13 and completed the Admission Nursing Assessment (P. Ex. 5) and the Admission Skin Assessment (P. Ex. 10). Tr. at 292, 294. She cleaned the coccyx sore with soap and water and applied Vaseline. Id. at 299. Also on Friday, she called Dr. Preuss "several times," which, to her, meant more than three. Id. at 305. She copied her Admission Skin Assessment notes (P. Ex. 10) into the nursing notes because (1) "because I'm thorough" (Tr. at 297) and (2) because the Admission Skin Assessment documenting the sore "does not stay in her . . . chart" and a purpose of the notes is to give the next nursing shift information about the resident's condition. Id. at 297. At the hearing, she was not asked why she failed to record her four calls to the doctor in the nursing notes.

16. Petitioner also relies on an entry Nurse H. made on R. 13's weekly skin summary. P. Ex. 11. The principal portion of this form consists of sections labeled "1^st week," "2^nd week," "3^rd week," and "4^th week." The right bottom corner of the form has a front and back view of a naked body. Based on the information in the 'weekly' portions dated March 24, April 2, April 9, and April 16, 2000, I conclude that the form is used to record a weekly summary of a resident's skin problems. The entry in "4^th week" of March, which is dated Saturday, March 25, 2000, describes the bruises and pressure sore noted in R. 13's Admission Skin Assessment. The entry was not made by Nurse H. However, in the lower left corner section titled "Additional Summary" is an entry dated March 24 by Nurse H. In that entry, she states she cleaned and applied Vaseline to the coccyx sore and made "several attempts" to contact Dr. Preuss. It is not credible to me that Nurse H. would record this information on this form but not in her nursing notes. It is also not credible that her entry was made on the 24^th. Rather, it appears that this form was generated for R. 13 on the 25^th and the "additional summary" dated the 24 ^th was added subsequently.

17. I discount the testimony of Nurse R. who cared for R. 13 during the 11 p.m. to 7 a.m. shift on the 25 ^th. She represented that she kept the sore clean and dry, applied Vaseline and reminded R. 13 to reposition herself frequently. Tr. at 419. However, her only entry in the nursing notes is at 3:45 a.m. and mentions neither the pressure sore nor any of these actions. P. Ex. 4, at 1.

18. Nurse B. testified as to her care of R. 13 on Monday, the 27 ^th. She testified that she encouraged R. 13 to stay off her coccyx and called the doctor for an order. These two actions are reflected in her note entries. P. Ex. 4, at 3. She also testified she applied Vaseline. However, the care R. 13 received prior to Nurse B.'s shift on Monday did not comply with the Interim Skin Care Policy.

19. In fact, Nurse H. agreed that Vaseline did not promote healing of pressure sores. Tr. at 303.

20. Additionally, a CMS witness testified that R. 13 told her she was in pain from the pressure sore. Tr. at 153; see also CMS Ex. 5, at 3. Unnecessary pain, caused by a delay in treatment to promote actual healing, would constitute actual harm. Community Nursing Home, DAB No. 1807 (2002). However, the evidence is conflicting on this point as Petitioner's nursing notes repeatedly state that R. 13 denied being in any pain or discomfort. P. Ex. 4, at 1-3; see also Tr. at 306, 324. I do not reach this question because it is unnecessary to my determination.

21. The Administrator explained that the rooms on the first floor do have sinks. However, R. 7 was on the second floor where the facility maintained its Medicare certified beds. Tr. at 280.