SUBJECT:

Josephine Sunset Home,

Petitioner,

Centers for Medicare & Medicaid

DECISION

I find that Petitioner, Josephine Sunset Home, failed to comply substantially with Medicare participation requirements during a period that began in May, 2002 and which ran until July 5, 2002. Consequently, I sustain the determination of the Centers for Medicare & Medicaid Services (CMS) to impose against Petitioner the remedy of denial of payment for new admissions for each day of a period that began on June 15, 2002 and which ended on July 5, 2002. I also sustain Petitioner's loss of its nurse aide training program as a result of its noncompliance with Medicare participation requirements.

I. Background

Petitioner is a skilled nursing facility that is located in Stanwood, Washington. It participates in the federal Medicare program. Its participation in that program is governed by regulations that are contained in 42 C.F.R. Parts 483 and 488. The Part 483 regulations enumerate quality of care and other requirements that a skilled nursing facility must meet in order to participate in Medicare. The Part 488 regulations describe CMS's enforcement authority and the remedies that CMS may impose for noncompliance by a facility with the Part 483 regulations.

The allegations of noncompliance and CMS's subsequent remedy determinations arise from a compliance survey of Petitioner that was completed in May, 2002 (May survey) by the Washington State Department of Social and Health Services, Residential Care Services Division, Region 3 (Washington State survey agency). Based on that survey the Washington State survey agency found that Petitioner was not complying substantially with Medicare participation requirements. CMS accepted those findings. CMS determined to impose a remedy against Petitioner consisting of denial of payment for new admissions for a period that began on June 15, 2002 and which ended on July 5, 2002. Petitioner also lost its authority to conduct nurse aide training as a consequence of the scope and severity of CMS's deficiency findings.

Petitioner contested CMS's deficiency findings and remedy determinations. It requested a hearing. The case was docketed and assigned to me for a hearing and a decision. Petitioner moved for summary disposition. CMS cross-moved for summary disposition. In a letter dated April 18, 2003, counsel for Petitioner stated that Petitioner rested on its written submissions and averred that an in-person hearing was not necessary to decide this case.

Each party filed exhibits. The exhibits that CMS filed are CMS's exhibits (CMS Exs.) 1 - 13, 17, 20 - 30, and 32 - 35, and CMS reply exhibits (CMS Reply Exs.) 1 - 3. ⁽¹⁾ The exhibits that Petitioner filed with its motion for summary disposition are Petitioner's exhibits (P. Exs.) 1 - 19. I am receiving all of these exhibits into evidence.

II. Issues, findings of fact and conclusions of law

A. Issues

The issues in this case are whether:

1. Petitioner failed to comply substantially with one or more Medicare participation requirements beginning in May, 2002 and continuing until July 5, 2002;

2. CMS is authorized to impose remedies based on Petitioner's failure to comply substantially with one or more participation requirements; and

3. Petitioner's noncompliance with participation requirements is sufficient to justify its loss of nurse aide training authorization.

The Washington State survey agency originally found that Petitioner had not complied with several participation requirements. However, the parties have agreed that the remedy determinations in this case are based only on Petitioner's alleged noncompliance with two participation requirements. The requirements with which Petitioner allegedly failed to comply are stated at 42 C.F.R. §§ 483.25(c) and 483.25(h). Petitioner's alleged noncompliance with these requirements is discussed at Tags 314 and 323 of the report of the May survey. CMS Ex. 1.

B. Findings of fact and conclusions of law

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

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

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

The regulation at 42 C.F.R. § 483.25(c) establishes standards to govern the prevention and treatment of pressure sores by a facility. It specifies that a resident who enters a facility without pressure sores must not develop a pressure sore unless that resident's clinical condition establishes that pressure sores were unavoidable. And, it requires that a resident who has pressure sores must receive treatment and services that are necessary to promote healing, prevent infection, and prevent new sores from developing.

CMS argues that Petitioner failed to comply substantially with the requirements of the regulation both in that it allowed residents to develop avoidable sores and that it failed to provide necessary treatment and services to residents to promote healing, prevent infection, and prevent new sores from developing. It makes these assertions based on the care that Petitioner gave to two of its residents, identified in the report of the May survey as Residents #s 2 and 3. CMS Ex. 1, at 10 - 15.

CMS argues that, as a matter of law, a pressure sore should be deemed to be avoidable unless a facility can prove that its development was unavoidable. CMS contends that pressure sores that Resident # 2 developed in February and April, 2002 are presumptively avoidable.

CMS argues also that Petitioner failed to provide care that was necessary to treat Resident # 2's sores or to prevent new ones from developing. It contends that Petitioner's staff did not document the progress of the resident's sores frequently or consistently. It asserts that, although heel protectors had been prescribed for the resident the staff failed to document whether the resident was wearing heel protectors. It contends that the resident was observed not to be wearing heel protectors during the survey and that Petitioner's nursing assistants had not been given instructions concerning the resident's use of heel protectors. CMS contends that I should infer that the resident was not always receiving the care that had been prescribed - especially heel protectors - from the failure by Petitioner to instruct its nursing assistants about the need to assure that the resident wore heel protectors, from the failure of Petitioner's staff to document the resident's use of heel protectors, and from the observed failure of the resident to be wearing heel protectors while in bed.

CMS relies on Petitioner's treatment records of Resident # 2 to support its contentions. CMS Ex. 1, at 11 - 12. It also relies on observations made by the Washington State survey agency surveyor who surveyed Petitioner in May, 2002 for compliance with the pressure sore regulation. Id. Additionally, CMS relies on the testimony of Courtney H. Lyder, N.D., G.N.P., F.A.A.N. CMS Exs. 32, 35.

Dr. Lyder opined that Petitioner's efforts at preventing the development of pressure sores by Resident # 2 were substandard. CMS Ex. 32, at 5. She averred also that pressure sores experienced by the resident were preventable. Id. at 6. She asserted that lack of assessment led to the lack of aggressive pressure sore prevention. Id. She also cited to inconsistent documentation of the care given to the resident and repeated failures to assure that the resident received the care that had been prescribed to her as support for her conclusions that preventive care and treatment were substandard. Id.

CMS asserts that Resident # 3 also developed an avoidable pressure sore while living in Petitioner's facility. This resident had lived at the facility since August, 2001. He was first observed to have developed a sore in the coccyx area on December 23, 2001. CMS Ex. 1, at 14. The sore increased in size between that date and the May survey. Id. at 13 - 15.

CMS argues that I should presume that this sore was avoidable. CMS argues further that Petitioner failed to provide this resident with care that was necessary to prevent or treat pressure sores. In particular, CMS asserts that the resident was not provided consistently with a gel cushion that had been prescribed to relieve pressure on the resident's coccyx while the resident was seated. As support for this assertion, CMS cites to observations that, on May 6, 7, 8, 9, and 10, 2002, the resident was not supplied with a gel cushion while seated in a recliner or a wheelchair. CMS Ex. 1, at 14 - 15.

CMS also contends that Petitioner did not effectively adjust the treatment for Resident # 3's pressure sore even though the sore was not healing and was, in fact, enlarging and deepening with the passage of time. CMS points to the resident's treatment record which shows that, on December 23, 2001, the resident was prescribed Lanaseptic as a principal treatment for the sore. CMS Ex. 32, at 7. However, this was not changed to another agent until April 29, 2002, after the sore had progressively deteriorated. Id. In reviewing this evidence, Dr. Lyder observed that the slow response by Petitioner's staff was compounded by the fact that the continued use of Lanaseptic to treat the resident's sore for so long a period appeared to be inappropriate in light of the development of necrotic tissue in the wound bed. Id.

I find that the evidence that CMS relies on to support its contentions establishes a prima facie case that Petitioner failed to prevent the development of avoidable pressure sores in the cases of Residents #s 2 and 3. I agree with CMS's argument that there is a rebuttable presumption in law that any pressure sore developed by a resident of a facility while living in that facility is avoidable. Koester Pavilion, DAB No. 1750, at 34 (2000). Thus, CMS has established a prima facie case of failure by Petitioner to prevent the development of avoidable sores by showing that Residents #s 2 and 3 developed sores while they lived at Petitioner's facility.

I find also that CMS proved, prima facie, that Petitioner failed to provide necessary care to Residents #s 2 and 3. Observations that the residents were not provided the pressure-relieving devices that had been ordered for them is proof that Petitioner failed to provide necessary care. There is additional prima facie evidence of dereliction of duty by Petitioner, consisting of evidence showing that it failed to track systematically the progress of Resident # 2's sores, and that it failed to adjust the medication prescribed to Resident # 3 despite the fact that Resident # 3's sore worsened with the passage of time.

Evidence of Petitioner's failure to prevent or to treat adequately the residents' sores is prima facie proof that Petitioner's deficiencies posed a potential for more than minimal harm to the residents. The development of an avoidable pressure sore by a resident is in and of itself evidence of harm to that resident. The evidence in this case also shows that the residents' conditions deteriorated during a period of time when the prima facie proof is that Petitioner was not providing them with necessary care.

I do not find that Petitioner's arguments and evidence rebutted CMS's prima facie case of noncompliance. Petitioner did not prove to be unavoidable the development of pressure sores by Residents #s 2 and 3. Nor did Petitioner overcome the prima facie evidence which shows that it was derelict in providing necessary treatments to these two residents.

Petitioner argues, first, that the pressure sores that were sustained by Resident # 2 were unavoidable. According to Petitioner, Resident # 2 was declining, and, in fact, died on October 4, 2002. Petitioner links the resident's pressure sores to the alleged decline in the resident's condition. It asserts that it made every conceivable attempt to prevent the development of pressure sores by Resident # 2. Petitioner's brief at 20.

To support this assertion Petitioner relies on a declaration by Rebecca J. O'Brien, R.N., Petitioner's director of quality assurance. P. Ex. 6. Ms. O'Brien opines that:

Although Resident # 2's blisters were over a bony prominence, we question their etiology. She had been experiencing a general deterioration over several months and we believed her to be in the dying process.

Id. at 10. I find that Ms. O'Brien's testimony does not establish that the resident's sores were unavoidable. Her testimony does not refer to clinical evidence that would prove Resident # 2's pressure sores to be unavoidable. Indeed, it does not contain even a clear assertion that the sores were unavoidable. Ms. O'Brien only questions the etiology of the resident's sores without proving that they were the unavoidable consequence of some clinical condition.

Petitioner has not offered any clinical evidence or opinion to show that the sore that was experienced by Resident # 3 was unavoidable. Rather, it argues that, perhaps, the wound sustained by the resident was not, in fact, a pressure sore. According to Ms. O'Brien, the etiology of the wound was more in the nature of a mechanical injury than a sore. P. Ex. 6, at 10. I find this assertion not to be persuasive. First, it is speculative. Furthermore, it contradicts the assessments of the resident's sore that were made by Petitioner's staff. Resident # 3 displayed an open wound on his coccyx for months. During that period Petitioner's staff referred to and treated the wound consistently as a pressure sore. CMS Ex. 20, at 19 - 22. Petitioner's own wound specialist, Aundrea Pippel, acknowledges that the resident had a pressure sore caused by his sleeping in a recliner chair due to chronic obstructive pulmonary disease. P. Ex. 7, at 3.

In fact, Ms. Pippel's testimony supports the conclusion that the resident's sore was avoidable. Petitioner should have anticipated the possibility that Resident # 3's extensive use of a recliner might pose pressure-related problems.

Petitioner argues also that the care that it gave to Residents #s 2 and 3 comported with regulatory standards. In its defense Petitioner lists the interventions it made on these residents' behalf. Petitioner's brief at 17 - 22. I do not disagree with Petitioner that it actively provided care to both Resident # 2 and # 3 or that it sought to heal the sores that these residents developed. Petitioner plainly did not neglect these residents. But, the issue here is not whether Petitioner was indifferent to the residents' needs but whether it did all that it should have done to address the residents' pressure sores. In that respect, I find that Petitioner did not address the central allegations that were made by CMS.

For example, and as I discuss above, the prima facie evidence offered by CMS is more than sufficient for me to infer it was absolutely essential that Resident # 2 wear heel protectors at all times that the resident was in bed, but that the resident did not wear heel protectors consistently. Petitioner acknowledges that the use of heel protectors was mandated by the resident's condition. "There is no other treatment that is effective for healing heel blisters." P. Ex. 6, at 9. But, Petitioner has not shown that Resident # 2 consistently wore heel protectors during the period of time when she suffered from pressure sores to her heels. Thus, Petitioner did not refute CMS's prima facie case that the resident wore heel protectors only sporadically.

Nor did Petitioner disprove CMS's prima facie case that Resident # 3 needed to use a gel cushion as a pressure relieving device. Moreover, Resident # 3 was not using the gel cushion that had been prescribed for him, and Petitioner failed to address the problems - including a worsening pressure sore - resulting from non-use of the gel cushion. Petitioner's response to CMS's prima facie case is to argue that the resident failed to use the cushion because he didn't like it. P. Ex. 7, at 3. That may be so. But, it is apparent from Petitioner's own evidence that the resident's principal problem was that he was experiencing pressure to his coccyx, causing him to develop a worsening pressure sore at that site. Relief from such pressure was mandatory. Given that, it was not enough for Petitioner simply to offer the resident the opportunity to use a cushion. Petitioner should have assessed what alternative approaches could have been used and should have attempted to implement them if the resident was not using the cushion.

b. Petitioner failed to comply substantially with the requirements of 42 C.F.R. § 483.25(h).

The regulation at 42 C.F.R. § 483.25(h) requires that a facility's resident environment remain as free of accident hazards as is possible. Additionally, it requires that each resident receives adequate supervision and assistance devices to prevent accidents. This regulation has been the subject of much litigation before the Departmental Appeals Board. The regulation does not impose a strict liability standard on facilities for accidents sustained by residents. Koester Pavilion, DAB No. 1750, at 24. A facility must, however, do all that it reasonably can do to prevent residents from sustaining accidents that are foreseeable. Woodstock Care Center, DAB No. 1726, at 25 - 27 (2000).

CMS focuses on episodes involving residents who are identified as Residents #s 7 and 5 to support its allegations that Petitioner failed to comply substantially with the requirements of 42 C.F.R. § 483.25(h). Each of these residents sustained falls. CMS alleges that Petitioner should have been aware of each resident's vulnerabilities and should have taken precautions to eliminate accident hazards, which precautions Petitioner failed to take.

The prima facie evidence offered by CMS shows that Resident # 7 had suffered a stroke and was noted by Petitioner's staff to be confused. CMS Ex. 25, at 7; CMS Ex. 20, at 28. The resident had a history of falls, with episodes occurring in August, September, and November, 2001, and in February and March, 2002. CMS Ex. 20, at 31; CMS Ex. 22, at 12. The falls that occurred in February and March, 2002 were from the resident's bed. Each of these falls occurred as the resident attempted to get out of bed without assistance. CMS Ex. 25, at 5, 7.

On April 14, 2002, the resident again fell from her bed and sustained injuries as a consequence. CMS Ex. 25, at 1 - 3, 9 - 11. The bed had foot brakes but had no brakes at the front end. The front end of the bed was on caster wheels which enabled the bed to roll from side to side. Id. at 1. The bed had been placed against the wall of the resident's room. The resident was found, lying on the floor, between the bed and the wall. Id. at 2 - 3, 11. The bed had rolled or slid approximately two and one-half feet away from the wall and the resident had fallen into the resulting space. Id.

CMS offered prima facie evidence to establish that Resident # 5 had a memory deficit and needed reminding about safety precautions such as using the brakes on her wheelchair. CMS Ex. 27, at 7 - 8. The resident sustained many falls between September 4, 2001, the date of the resident's admission to Petitioner's facility, and April, 2002. CMS Ex. 27, at 4.

CMS's prima facie evidence concerning this resident also is that, on May 8, 2002, a surveyor observed Resident # 5 to be on the floor by her bed. CMS Ex. 1, at 16. The resident was observed to attempt to pull herself up off of the floor by grasping a horseshoe shaped bed bar that was attached to her bed. Id. The bed rolled or slid towards the resident as she attempted to rise from the floor. Id. The resident's treatment records noted that the resident used the bed bar to steady herself when she attempted to get up or down. But, there was nothing in the records that instructed Petitioner's staff to be sure that the brakes were locked on the resident's bed. Id. at 16 - 17.

The evidence offered by CMS shows that Petitioner knew that both Residents #s 7 and 5 had mental deficits which could limit their ability to understand and to deal with risks and hazards. Petitioner also knew that both Residents #s 7 and 5 were at risk for falling. More significantly, the prima facie evidence is that both residents were at risk for accidents involving their beds. In the case of Resident # 7, the resident had sustained at least two falls from bed prior to the fall that the resident sustained on April 14, 2002. Resident # 5 not only had sustained multiple falls but the resident was known to grasp onto her bed to steady herself. In fact, Petitioner's staff encouraged this behavior by placing a bed bar on the bed which the resident could use as a steadying device.

The prima facie evidence supports the conclusion that Petitioner should have known that it was absolutely essential that each of the residents' beds be as stable as possible and not be prone to rolling or sliding. Petitioner knew that accidents involving the residents' beds were highly probable given the residents' histories. In fact, Petitioner did attempt to address this concern by placing Resident # 7's bed against the wall. But, the prima facie evidence shows that, both in the cases of Residents # 7 and # 5, Petitioner failed to consider whether the unbraked wheels on the residents' beds might be a hazard. In the case of Resident # 5, Petitioner had not addressed this issue by May, 2002, weeks after Resident # 7 had sustained her accident.

The evidence offered by CMS supports the overall conclusion that Petitioner failed to comply substantially with the requirements of 42 C.F.R. § 483.25(h). From this evidence I may find that there were accident hazards in Petitioner's facility that Petitioner knew about but which it failed to eliminate. As a consequence, one resident sustained actual harm and there was a continuing potential for serious harm to residents.

I find that Petitioner failed to rebut CMS's prima facie case either as to Resident # 7 or Resident # 5. Consequently, I find that Petitioner was not complying substantially with the regulation.

Petitioner argues that it could not have foreseen the accident that occurred to Resident # 7 on April 14, 2002, because the resident "had never before attempted to get out of the side of the bed against [the] wall." Petitioner's brief at 26. Although that may be correct, it does not mean that the accident was unforeseeable. Petitioner knew that the resident had a penchant for attempting to climb out of bed unassisted and had, in fact, fallen from her bed at least twice previously. In light of that, Petitioner should have assured that the bed was stable and not prone to sliding or rolling.

Petitioner also argues that it could not have foreseen that Resident # 7 would push against a wall with sufficient strength to cause her bed to slide or roll away from the wall, given that the bed was on carpeting and "with the foot brakes locked." Petitioner's brief at 26. But, the problem was that there were no brakes at the head of the resident's bed. There, the wheels could and did roll freely and that is what caused the bed to roll or slide away from the wall. Petitioner should have been aware of that problem in view of the resident's history.

Finally, Petitioner avers that there were no prior episodes involving Resident # 7 that would have alerted Petitioner to the need to stabilize the resident's bed. I disagree with that assertion. The resident had already fallen from her bed at least twice prior to the April 14, 2002 episode. Petitioner knew that the resident was likely to attempt to climb out of her bed unassisted. Petitioner also knew that the resident was confused and should have known that the resident's confusion might make her prone to committing judgment errors. That knowledge was sufficient to put Petitioner on notice that the bed had to be stabilized. Indeed, Petitioner clearly knew that stabilization of the resident's bed was necessary, given that Petitioner placed the bed against the wall prior to the April 14, 2002 accident. What Petitioner failed to take into account - through obvious oversight - was that this measure did not stabilize the head of the bed sufficiently, because the legs at that end of the bed were on unbraked wheels.

Petitioner argues that it could not reasonably have been expected to know that Resident # 5's bed, with unbraked wheels, posed a significant hazard to the resident. Petitioner asserts that it had no reason to have concern about the bed because the resident had no history of falls involving the bed. See Petitioner's brief at 27. Petitioner avers that there is no evidence that the bed contributed to the resident's apparent fall, as observed by the surveyor on May 8, 2002. Id. Petitioner argues also that it was not made aware of any possible safety hazard involving Resident # 5's bed until it received the report of the May survey on May 29, 2002. Id.

I find these arguments to be unpersuasive. Petitioner should have known that Resident # 5's bed posed a hazard to the resident. This resident was extremely unsteady on her feet, and had fallen many times. Petitioner had installed a bar on the resident's bed and had encouraged the resident to use the bar for support when attempting to get into or out of the bed. That made it imperative that the bed be stabilized. Leaving the bed on rollers and encouraging the resident to use the bed bar for support invited an accident because a potential existed for the bed to roll back against the resident any time the resident pulled on the bar. That is precisely what the surveyor observed on May 8, 2002. CMS Ex. 1, at 16. Petitioner should have known that the risk to the resident was exacerbated by her memory deficit. In fact, Petitioner's staff had issued guidance to the effect that the resident's memory deficit was such as to require that the resident be reminded to lock her wheelchair brakes. The need to protect the resident by assuring that the resident's bed brakes were locked follows logically from this guidance.

2. Petitioner did not prove that it attained substantial compliance with participation requirements before July 5, 2002.

A presumption attaches to a noncompliance finding by CMS that the facility remains out of compliance until CMS certifies the facility is back in compliance. Here, CMS determined that Petitioner remained out of compliance until July 5, 2002, when CMS certified that Petitioner had attained substantial compliance.

Petitioner has offered no persuasive evidence to refute CMS's duration determination. It has not argued that it attained compliance with either of the participation requirements that are at issue in this case prior to July 5, 2002, assuming that it was not complying substantially with either of them as of the May survey.

3. A basis exists to sustain CMS's remedy determination.

The regulations at 42 C.F.R. Part 488 authorize CMS to impose remedies, including denial of payment for new admissions, against a facility that is not complying substantially with participation requirements. 42 C.F.R. § 488.406. The evidence in this case establishes Petitioner to have not been complying substantially with participation requirements from June 15, 2002 until July 5, 2002. Findings 1, 2. Consequently, CMS was authorized to impose remedies against Petitioner, which may include denial of payment for new admissions for each day of this period.

4. Petitioner's noncompliance with participation requirements is sufficient to justify its loss of nurse aide training authorization.

Petitioner lost its authorization to conduct nurse aide training as a consequence of CMS's acceptance of the scope and severity determination made by the Washington State survey agency for the two deficiencies that are at issue in this case. Under applicable regulations, a facility will lose its authorization to conduct nurse aide training if it manifests deficiencies that establish a substandard quality of care. The term "substandard quality of care" is defined at 42 C.F.R. § 488.301 to mean one or more deficiencies involving any of the participation requirements that are stated at 42 C.F.R. §§ 483.13, 483.15, or 483.25, 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.

As a general rule, a facility may not challenge the level of a deficiency determination. However, an exception to that rule is where a determination of substandard care is made which results in loss of nurse aide training 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 and Petitioner has not rebutted that evidence. Both of the deficiencies at issue in this case involved actual harm to residents and were at least widespread in the sense that they involved more than one resident. Petitioner has not contended, nor has it offered evidence to prove that, if deficiencies were present as of the May survey, that they were of a lesser scope and severity than that which was determined to be the case by CMS.

Steven T. Kessel

Administrative Law Judge

1. CMS filed its exhibits in anticipation of hearing without submitting a copy for the record file, as the record copy would have been offered at the hearing. Although it did not submit a record copy of its exhibits, I admit one of the two copies of the exhibits it did submit as the record copy. Where CMS filed an amended exhibit, I take into evidence only the final exhibit filed by CMS.