SUBJECT:

Meadow Wood Nursing Home,

Petitioner,

Centers for Medicare & Medicaid Services.

DECISION

Petitioner, Meadow Wood Nursing Home, is a long-term care facility certified to participate in the Medicare and Medicaid programs as a provider of services. Petitioner challenges the Centers for Medicare & Medicaid Services' (CMS) determination that it was not in substantial compliance with program participation requirements. For the reasons discussed below, I affirm CMS's determination to impose a civil money penalty (CMP) of $2,700 against Petitioner based on this noncompliance.

I. Background

On November 21, 2002, in response to a complaint, the Ohio Department of Health (State agency) completed a survey at Petitioner's facility. The State agency found the facility to be noncompliant with the participation requirement at 42 C.F.R. � 483.25(h)(2) (F Tag 324 on the November 21, 2002 statement of deficiencies (SOD)), which requires a facility to provide its residents with adequate supervision and assistance devices to prevent accidents. The SOD also alleged that Petitioner's noncompliance resulted in actual harm to one resident. On December 12, 2002, CMS notified Petitioner that, based on the State agency's findings, it was imposing a $2700 per instance CMP against Petitioner.

On February 12, 2003, Petitioner requested a hearing, challenging the basis for the imposition of the CMP and contesting whether the amount of the CMP was reasonable. The case was assigned to me for the hearing, related proceedings, and decision. I held a hearing in this case on November 22, 2004, in Cincinnati, Ohio. At the hearing, I admitted CMS exhibits (Exs.) 1-18. Petitioner did not offer any exhibits. I heard the testimony of State agency surveyor Leatha Slusher Rose ⁽¹⁾ and of Petitioner's owner and administrator Jack Crout. A transcript of the hearing was made (Tr.). The parties also submitted posthearing briefs (CMS or P. Br.) and posthearing response briefs (CMS or P. R. Br.).

II. Issues

1. Whether Petitioner was out of substantial compliance with participation requirements.

2. Whether the $2700 per instance CMP imposed by CMS against Petitioner is reasonable.

III. Statutory and Regulatory Background

The Social Security Act (Act) sets forth requirements for long-term care facilities (Medicare skilled nursing facilities (SNFs) and Medicaid nursing facilities (NFs)) participating in the Medicare and Medicaid programs, and authorizes the Secretary of Health and Human Services to promulgate regulations implementing the statutory provisions. Act, sections 1819 and 1919. The Secretary's regulations governing long-term care facilities participating in the Medicare program are found at 42 C.F.R. Parts 483, 488, 489, and 498.

To participate in the Medicare program, a long-term care facility must maintain substantial compliance with program requirements. To be in substantial compliance, 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.

The seriousness of a deficiency depends on its scope and severity. See 42 C.F.R. � 488.404; State Operations Manual (SOM), App. P, sec. V. Severity refers to whether a deficiency has created the "potential for harm," resulted in "actual harm," or placed residents in "immediate jeopardy;" "scope" refers to whether the deficiency is "isolated," constitutes a "pattern," or is "widespread." Id.; see also 42 C.F.R. � 488.404(b)(1). A deficiency's seriousness is designated in the statement of deficiencies by a letter (A-L) that corresponds to a matrix reflecting different combinations of scope and severity. See SOM, section 7400(E). For example, a Level G deficiency refers to an "isolated" deficiency that causes "actual harm" (but not immediate jeopardy) to a resident.

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 includes 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), 488.440. A per instance CMP imposed for an instance of noncompliance will be in the range of $1,000 to $10,000 per instance.

IV. Burdens of Proof, of coming forward with Evidence, and of Persuasion

The preponderance of the evidence standard will be applied to resolve disputed issues of fact, except as provided by 42 C.F.R. � 498.60(c)(2), which states that in CMP cases CMS's determination as to the level of noncompliance of a facility must be upheld unless it is clearly erroneous. CMS bears the burden of coming forward with evidence sufficient to establish a prima facie case that Petitioner was not in substantial compliance with the participation requirements at issue. Once CMS has established a prima facie case, Petitioner has the ultimate burden of persuasion: to prevail, Petitioner must prove by a preponderance of the evidence that it was in substantial compliance with each participation requirement at issue. Batavia Nursing and Convalescent Inn, DAB No. 1911 (2004); Batavia Nursing and Convalescent Center, DAB No. 1904 (2004), applying Hillman Rehabilitation Center, DAB No. 1611 (1997), aff'd, Hillman Rehabilitation Center v. HHS, No. 98-3789 (GEB), slip op. at 25 (D.N.J. May 13, 1999).

V. Findings of Fact, Conclusions of Law, and Discussion

I make findings of fact and conclusions of law to support my decision in this case. I set forth each finding below, in italics, as a separate heading. I discuss each finding in detail.

1. Petitioner was out of compliance with the participation requirement at 42 C.F.R. � 483.25(h)(2) (F Tag 324) as of the survey ending on November 21, 2002.

Section 483.25(h)(2) of 42 C.F.R. requires that a facility must ensure that "[e]ach resident receives adequate supervision and assistance devices to prevent accidents." The Departmental Appeals Board (Board):

[H]as explained the responsibility of the facility to comply with this requirement as follows:

The Board has held that section 483.25(h)(2) cannot properly be read to impose strict liability on facilities for accidents that occur. Instead, the Board has found that the regulatory requirement of "adequate supervision and assistance devices to prevent accidents" obligates the facility to provide supervision and assistance devices designed to meet the resident's assessed needs and to mitigate foreseeable risks of harm from accidents. Id. [Northeastern Ohio Alzheimer's Research Center, DAB No.1935 (2004)]; see also Tri-County Extended Care Center, DAB No. 1936 (2004); Odd Fellow and Rebekah Health Care Facility, DAB No. 1839 (2002). In addition, the Board has indicated that a facility must provide supervision and assistance devices that reduce known or foreseeable risks to the highest practicable degree, consistent with accepted standards of nursing practice. Woodstock Care Center, DAB No. 1726, at 21, 25, 40 (2000), aff'd, Woodstock Care Ctr. v. Thompson, 363 F.3d 583 (6^th Cir. 2003); Florence Park Care Center, DAB No. 1931 (2004).

Residence at Kensington Place, DAB No. 1963, at 9 (2005); see also Estes Nursing Facility Civic Center, DAB No. 2000 (2005); Northeastern Ohio Alzheimer's Research Center, DAB No. 1935 (2004). Facilities have the "flexibility to choose the methods of supervision" to prevent accidents so long as the methods chosen are adequate in light of the resident's needs and ability to protect himself or herself from a risk. Golden Age Skilled Nursing & Rehabilitation Center, DAB No. 2026, at 11 (2006), citing Woodstock.

A prima facie case of noncompliance with this requirement would correspondingly be made if CMS presented evidence to show that a facility failed to provide adequate supervision and assistance devices to reduce the foreseeable risk of an accident to the highest practicable degree. If CMS set out such evidence, the burden shifts to the facility to rebut the evidence or present other evidence showing substantial compliance.

Alden Town Manor Rehabilitation & HCC, DAB No. 2054, at 10-11 (2006).

This case arises from a complaint survey conducted on a "record review" at Petitioner's facility. The F Tag in question, 324, deals solely with the care provided to one resident, Resident 30. In September and October of 2002, Resident 30 was experiencing falls from his wheelchair. Petitioner did not adequately assess Resident 30 after the falls and it did not develop interventions to mitigate the foreseeable risk that the Resident would continue to fall.

Specifically, on November 21, 2002, the State agency conducted a record review and staff interviews and, from that, determined that Petitioner failed to provide adequate supervision and assistance devices to Resident 30 to prevent accidents. ⁽²⁾ CMS Ex. 1. Resident 30 was 84-years-old at the time of the survey (CMS Ex. 8, at 3), and he had diagnoses including post stroke weakness in the upper and lower extremities of one side of his body ⁽³⁾, left hip fracture, severe macular degeneration, high blood pressure, and pneumonia. Tr. 23-24; CMS Ex. 6, at 6-9; CMS Ex. 8, at 1, 22-23. ⁽⁴⁾ Resident 30 also had moderately impaired cognitive skills, problems with short and long term memory, and was unaware of his safety needs. Tr. 25-29; CMS Ex. 6, at 6-9; CMS Ex. 7, at 3; CMS Ex. 8, at 6, 24. Resident 30 also required limited to extensive assistance with most activities of daily living and was unable to ambulate by himself or maintain his balance while standing. Tr. 27-29; CMS Ex. 7, at 1; CMS Ex. 8, at 1, 4.

In sum, Resident 30 was at high risk for falls due to his physical condition and poor safety awareness. Petitioner was aware of Resident 30's high fall risk. Tr. 30; CMS Ex. 8, at 4, 6-9, 18. In fact, Resident 30 had a history of falls from his wheelchair. In May 2002, Resident 30 fell from his wheelchair at least twice. CMS Ex. 8, at 18, 24. Resident 30 also had a tendency to slide to the edge of, and to lean forward and scoot down in, his wheelchair. CMS Ex. 8, at 24. Resident 30 spent most of his time in his wheelchair. CMS Ex. 8, at 24, 27. ⁽⁵⁾

Petitioner began using a personal alarm ⁽⁶⁾ on Resident 30 on July 31, 2001. CMS Ex. 8, at 6. The personal alarm was discontinued on August 22, 2002. CMS Ex. 8, at 26.

On September 4, 2002, Resident 30 fell from his wheelchair and was found by a certified nursing assistant (CNA) lying on the floor on his right side with a skin tear on his right elbow. CMS Ex. 8, at 8, 11, 25. After this fall, Petitioner did not perform any assessments to determine if any assistance devices or other interventions could be implemented to prevent further falls, and no interventions were added to his care plan to prevent falls from the wheelchair. Tr. 35; CMS Ex. 8, at 8, 25.

On September 7, 2002, Resident 30 slid forward out of his wheelchair and struck the left side of his head on the corner of an end table, falling forward onto the floor. CMS. Ex. 8, at 3, 9, 27. Resident 30 sustained a half-inch laceration on the left side of his head and was transported to the hospital because his pupils failed to react to light for approximately one minute after the fall. Id. After this fall, facility documentation does not reflect that assessments were performed to determine if any assistance devices or other interventions could be implemented to prevent further falls, and no new interventions were added to Resident 30's care plan to prevent further falls from his wheelchair. Tr. 40; CMS Ex. 8, at 9.

On September 8, 2002, Petitioner resumed using the personal alarm, the intervention that it had discontinued on August 22, 2002, and it was added to Resident 30's care plan. CMS Ex. 8, at 5, 26. Surveyor Slusher Rose testified that this was not an effective intervention, because Resident 30 had a past history of falling from his chair when a personal alarm was intact. The alarm did not keep him in his chair. Tr. 39.

Referring to Resident 30's September 21, 2002 care plan (CMS Ex. 8, at 4), Surveyor Slusher Rose noted facility interventions which included the personal alarm; monitoring the Resident every day to determine the level of assistance needed; and checking and toileting the Resident every two hours as needed to ensure that his personal hygeine tasks were completed. However, Surveyor Slusher Rose testified that these interventions could apply to any resident, with the exception of the personal alarm, as they are just general nursing, supervision and care interventions. Tr. 41-42. Surveyor Slusher Rose testified that the care plan was not adequate to address the Resident's risk of falling from his wheelchair. Tr. 43.

On October 10, 2002, while maneuvering his wheelchair closer to a radio in the lobby of Petitioner's facility, Resident 30 fell, striking his head on the floor. CMS Ex. 8, at 32. ⁽⁷⁾ Resident 30 sustained a laceration/hematoma to the post-cranial area. CMS Ex. 8, at 32-33. After this fall, Petitioner did not assess Resident 30 to determine if any assistance devices or other interventions could be implemented to prevent further falls and no interventions were added to Resident 30's care plan to prevent further falls from his wheelchair. Tr. 45.

Surveyor Slusher Rose testified that there were interventions the facility could have implemented in response to the Resident's falls in September and October. These interventions might have included a different type of wheelchair; modifications to his existing wheelchair, including positioning devices to keep him upright; determining the time of day falls were likely to happen; putting him down for a nap; putting a positioning device on him; assessing him for a restraint; putting him in more activities; using a non-skid mat in front of his chair; or using a wedge cushion (as they had earlier tried a pommel cushion which the Resident did not like). Tr. 45-47. But no interventions were put in place, for Resident 30 was not assessed after these falls.

On December 3, 2002, Petitioner revised Resident 30's care plan to provide for the use of a new wheelchair equipped with a front fastening seat belt and anti-tippers. Petitioner stated in its plan of correction that it also intended to implement the use of a gel cushion with an anti-slip device. CMS Ex. 6, at 2, 6.

Petitioner complains -- quite without reason or justification in the evidence -- that CMS found it out of compliance primarily because it did not purchase an expensive, motorized wheelchair for Resident 30. P. Br. at 2-3. Describing Resident 30's injuries as "self-inflicted" (P. R. Br. at 1), Petitioner asserts that Resident 30 intentionally put himself on the floor as an act of free will (although Petitioner did not offer any documentary evidence supporting this statement), and also as similar acts of free will slid out of his wheelchair legs first (which would negate the efficacy of gel pads), and refused restraints including a self-fastening seatbelt, footrests, and pommel cushions, as efforts to hamper his mobility. P. Br. at 6; P. R. Br. at 2-3. Specifically with regard to Resident 30's fall on October 10, 2002, Petitioner asserts as a fact that the Resident intentionally slid from his wheelchair while adjusting the radio. P. Br. at 6. Petitioner offered only the testimony of Mr. Crout for these assertions, and, uncorroborated by other evidence, I do not find his testimony to be probative on these matters, especially given his admission that he did not even review the entirety of the Resident's chart before testifying and did not witness Resident 30's falls. Tr. 112, 116, 142, 147. Petitioner does assert that the Resident listened to the radio in the facility's heavily trafficked lobby, implying that the Resident was supervised. P. Br. at 7. However, there is no evidence that Petitioner had specifically care-planned and relied on this crowded, busy setting as an active and suitable intervention to prevent his falls.

Petitioner's noncompliance here is not based on its failure to purchase a wheelchair, but on its failure to assess the Resident after each fall and to implement interventions (supervision and assistance devices) to reduce Resident 30's foreseeable risk of harm from accidental falls to the highest practicable degree. Even assuming that Resident 30's actions were a result of his "free will" -- an assertion that Petitioner did not prove and which, given the Resident's deficits of comprehension concerning his own physical safety, is an assertion remarkable chiefly in its cynicism -- Petitioner still had a duty to assess the Resident and to try to implement strategies to prevent such incidents. Petitioner does not credibly assert that such assessment or intervention was accomplished. Petitioner argues that, because the standard under the regulation is not one of strict liability, the mere fact of a fall, irrespective of a lack of evidence from CMS as to what level of supervision was actually provided to Resident 30, is not an adequate basis upon which to find Petitioner out of compliance with participation requirements. P. Br. at 10. Again, Petitioner misapprehends its citation for noncompliance.

Resident 30 was a fall risk. His eyesight was impaired. He had impairment in range of motion, weakness on one side of his body, and balance problems. He had some cognitive and memory impairment. He was unaware of his own safety needs. He had a tendency to slide and scoot in his wheelchair. See Tr. 29-30. Surveyor Slusher Rose testified credibly that an ongoing assessment should have been done after every fall because each fall could have extenuating or different circumstances. A facility would want to evaluate a resident's physical status to determine if the resident was ill or to evaluate the environment, such as chair position. This would enable a facility to put appropriate assistance devices in place to ensure resident safety in order to prevent the next fall. Tr. 36, 90. Petitioner was obligated to provide supervision and assistance devices designed to meet the Resident's assessed needs and to mitigate foreseeable risks of harm from accidents. Petitioner did not do so.

2. The CMP imposed is reasonable.

CMS has imposed a per instance CMP of $2700. Petitioner argues that the CMP is inappropriate, essentially because Petitioner is without the funds to pay it.

The regulations at 42 C.F.R. � 488.438(f) state the factors to be considered in determining the amount of a CMP. They include: (1) the facility's history of noncompliance, including repeated deficiencies; (2) the facility's financial condition; (3) the factors specified in section 488.404 (which include a determination of the seriousness of the deficiency (the scope and severity of the deficiencies) and whether the relationship of one deficiency to other deficiencies results in noncompliance, and the facility's prior history of noncompliance in general and with reference to the cited deficiencies); and (4) the facility's degree of culpability, which includes, but is not limited to, neglect, indifference, or disregard for resident care, comfort or safety. The absence of culpability is not a mitigating circumstance in reducing the amount of the CMP. When I evaluate the CMP imposed against the regulations, I review "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 (financial condition, facility history, and culpability)." Windsor Health Care Center, DAB No. 1902, at 17 (2003), quoting CarePlex of Silver Spring, DAB No. 1683, at 8 (1999).

Here CMS has shown that Petitioner had a prior history of noncompliance, including past noncomplaince with F Tag 324, as well as with other deficiencies. CMS Ex. 5, at 1 and 3. And, CMS has shown that the deficiency was serious, in that Resident 30 sustained actual harm (which the SOD reflects was determined to be at a level "G"). CMS Ex. 1, at 1. On September 4 he sustained a skin tear on his elbow, on September 7 he hit his head and became unconscious, and, on October 10, he sustained a laceration/hematoma. Moreover, the noncompliance is serious because, in the absence of robust assessment and attempted interventions to prevent falls, Resident 30 was likely to fall again. Based on the evidence CMS presented, I would experience no reluctance in sustaining a CMP at a higher level than that imposed, as $2700 is at the lower end of the range of per instance CMP that CMS could have imposed. The only question remaining is whether the evidence that Petitioner presented with regard to its financial condition mitigates against imposing the $2700 CMP. I find that it does not.

The only evidence Petitioner presented regarding its financial condition is Mr. Crout's testimony. Mr. Crout testified that in calendar year 2004 Petitioner lost $200,000 and asserts further that Petitioner has lost money each year since 2002. Tr. 126. However, Petitioner did not present documentary evidence of this or of any other aspect of its financial picture in 2003 or 2004. Tr. 130. In 2002, Petitioner had cash on hand of $106,084, cash assets totaling $759,167, and liabilities of $457,364. CMS Ex. 4, at 1. Mr. Crout testified he did not know how much cash on hand Petitioner currently had, and could not supply any specific details with regard to the company's cash flow. Tr. 132-33. Mr. Crout explained that he was not aware of this information because he was not an accountant and that only his accountant would be able to decipher the cost report submitted by CMS. Id.; CMS Ex. 4, at 1. Petitioner's argument regarding its financial condition is not compelling. Mr. Crout never testified that paying the CMP would put Petitioner out of business. It is Petitioner's responsibility to show that it cannot pay the CMP, and Petitioner was free to call its accountant or any other witness to testify to its financial condition or to submit any documentary evidence regarding its financial condition. Petitioner did not do so.

In assessing Petitioner's financial condition, the key factor is whether it has adequate assets to pay the CMP without going out of business or compromising resident safety. Windsor Health Care Center, DAB No. 1902, at 18. Petitioner has not shown that paying the CMP will cause it to go out of business or compromise resident safety.

VI. Conclusion

I conclude that Petitioner was out of compliance with the participation requirement at 42 C.F.R. � 483.25(h)(2) (F Tag 324). Accordingly, CMS was authorized to impose a CMP. I find the CMP imposed, $2700, to be reasonable.

Richard J. Smith

Administrative Law Judge

1. Survey documents identify Surveyor Slusher Rose as "Slusher." She changed her name to "Rose" after her marriage on May 10, 2003, which took place after the survey. I refer to her as Surveyor Slusher Rose. Surveyor Slusher Rose was the team leader for the survey in question here. Tr. 22. Petitioner has attacked Surveyor Slusher Rose's credibility as a surveyor. P. R. Br. at 3. I find Surveyor Slusher Rose's training, education, and experience as a surveyor to be sufficient to provide reliable testimony in her capacity as a nurse and as a surveyor in determining whether facilities are in compliance with participation requirements. CMS Ex. 17.

2. Petitioner argues that the fact that Surveyor Slusher Rose relied on document review and staff interviews to make her findings (and, according to Petitioner, did not: observe an incident of non-supervision; interview the Resident, his guardian, or his power of attorney; speak with nursing staff who witnessed the falls or incidents and who were responsible for generating the nurse's notes; or speak with the physical therapist) somehow nullifies the finding of noncompliance. P. Br. at 4. However, if the evidence gathered through record review and staff interviews is sufficient to prove a prima facie case (as it is here), it is up to Petitioner to rebut that case. Petitioner had the opportunity to present the testimony of any witness and to introduce any documentary evidence it chose to rebut CMS's case. As an example, I note Petitioner's assertion that documents Surveyor Slusher Rose relied on were absent from CMS's exhibits, including Resident 30's October 2002 minimum data set (MDS) from which Surveyor Slusher Rose extracted excerpts included in her surveyor notes. If Petitioner disagreed with Surveyor Slusher Rose's summary, Petitioner, who retained the document in its files, could have offered it at hearing.

3. I note that the facility's records, as discussed by Surveyor Slusher Rose in her testimony, conflict as to whether the Resident's weakness was on the right or left side of his body. Tr. 24. For purposes of this decision, the only relevant fact is that Resident 30 had weakness on one side of his body.

4. CMS asserts that Resident 30 also had diagnoses of kyphosis (hunchback), scoliosis (curvature of the spine), and lordosis (curvature of the lumbar spine). CMS Br. at 4, citing Tr. 23-24; CMS Ex. 18, at 11. I admitted CMS Ex. 18 (which includes a letter of medical necessity, prepared by a physical therapist named Tracy Boone and signed by Resident 30's physician), which was apparently prepared to enable Resident 30 to get a new wheelchair. Petitioner has asserted that this document was not generated by the facility, had no connection with facility staff, and appears to be an unsolicited and fabricated attempt by an outside company to sell a wheelchair. Petitioner also asserts that the spinal conditions noted as grounds to obtain the wheelchair were not noted in facility records until after the survey. P. Br. at 5. As I find it unnecessary to refer to these conditions, I do not rely on the letter of medical necessity contained in CMS Ex. 18, or the conditions described therein.

5. CMS asserts, based in part on the letter of medical necessity, that Resident 30's wheelchair was inappropriate for him. I do not need to determine whether the wheelchair was inappropriate to make my decision here.

6. A personal alarm is a device which is clipped to a resident's clothing by a cord and positioned out of reach of the resident. When the resident leans forward or attempts to stand up, the cord unclips from the device which emits a high sound to alert staff a resident is attempting to stand or move inappropriately. Tr. 32.

7. Mr. Crout asserted that Resident 30 was adjusting the radio when he fell on October 10, whereas nurse's notes reflect that he was trying to maneuver his chair so he could be near the radio. Tr. 148. This discrepancy is irrelevant to my determination here, where Petitioner's noncompliance is its failure to adequately assess the Resident and implement interventions to prevent foreseeable accidents.