SUBJECT:

Cherrywood Nursing and Living Center,

Petitioner,

Centers for Medicare & Medicaid Services

DECISION

I sustain the decision of the Centers for Medicare & Medicaid Services (CMS)⁽¹⁾ to impose a per instance civil money penalty (CMP) in the amount of $1,500 against Petitioner, Cherrywood Nursing and Living Center.

I. BACKGROUND

Petitioner is a long-term care facility that is located in Sterling Heights, Michigan. Petitioner is a participant in federally funded health care programs, including the Medicare program. On October 3, 2000, CMS notified Petitioner that it was imposing a $1,500 CMP against Petitioner based on an August 17, 2000 survey by the Michigan Department of Consumer and Industry Services (State survey agency) which found Petitioner had failed to comply substantially with federal participation requirements governing long-term care facilities. Petitioner requested a hearing. The case was originally assigned to Administrative Law Judge Mimi Hwang Leahy. CMS requested that Judge Leahy allow it to file a a motion for summary affirmance and suggested a briefing schedule for the motion to which Petitioner agreed. Judge Leahy adopted the briefing schedule suggested by CMS and agreed to by Petitioner. The case was reassigned to me on May 8, 2001.

CMS filed its motion, accompanied by a brief (CMS Br.) and 24 exhibits (CMS Exs. 1 - 24). Petitioner filed its response and a counter motion for "summary affirmance" (P. Br.), accompanied by attachments consisting of copies of five Departmental Appeals Board decisions and the September 26, 2000 notice of imposition of remedies from the State survey agency to Petitioner. CMS submitted a reply (CMS Reply Br.). Petitioner submitted a sur-reply (P. Reply Br.), accompanied by 16 exhibits (P. Exs. 1 - 16). In the absence of objection, I am admitting CMS Exs. 1 - 24 and P. Exs. 1 - 16 into evidence.

II. ISSUES

The relevant issues in this case are whether:

1. It is appropriate to decide this case based on the parties' written submissions;

2. Petitioner failed to comply substantially with a federal participation requirement, causing actual harm;

3. CMS may impose remedies, including a per instance CMP of $1,500;

4. Petitioner may appeal a deficiency from a prior survey cycle where, although no remedy was imposed, the deficiency was considered by CMS when it computed the amount of the CMP in a later survey cycle.

III. GOVERNING LAW

The Social Security Act (Act) sets forth requirements for long term care facilities, both skilled nursing facilities and nursing facilities (nursing facility), 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 nursing facility participation in the Medicare program are found at 42 C.F.R. Part 483.

Under the "quality of care" requirement, each resident must receive and a facility must provide the necessary care and services to attain or maintain a resident's highest practicable physical, mental, and psychosocial well-being, in accordance with the resident's comprehensive assessment and plan of care. 42 C.F.R. � 483.25. Specifically relevant to this case, a facility must ensure that each resident receives adequate supervision and assistance devices to prevent accidents. 42 C.F.R. � 483.25(h)(2). The State Operations Manual (SOM) defines an "accident" to be "an unexpected, unintended event that can cause a resident bodily injury. It does not include adverse outcomes associated as a direct consequence of treatment or care, (e.g., drug side effects or reactions)." CMS Ex. 22.

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. One of the remedies CMS is authorized to impose is a CMP (42 C.F.R. � 488.406(a)(3)), including a CMP of from $1,000 to $10,000 per instance of noncompliance (42 C.F.R. � 488.408(d)(iv)) in a case where one or more deficiencies constitute actual harm that is not immediate jeopardy (42 C.F.R. � 488.408(d)(2)(ii)).

The minimum amount to be imposed for a per instance CMP is $1,000. Id.

If there is a basis for imposing a remedy, an administrative law judge may not review CMS's choice of remedy or reduce the amount of the CMP below the minimum amount for the appropriate range of CMPs. 42 C.F.R. � 488.438(e)(1), (2). Moreover, in reviewing the reasonableness of the amount of a CMP, an administrative law judge can only consider the factors specified at 42 C.F.R. �� 488.438(f) and 488.404.

A nursing facility can appeal only from a CMS initial determination, such as a finding of noncompliance that results in the imposition of a CMP. 42 C.F.R. � 498.3. A nursing facility is precluded from appealing deficiencies that are not the basis for a remedy imposed by CMS. Arcadia Acres, Inc., DAB CR424 (1996); aff'd DAB No. 1607 (1997).

CMS bears the burden of producing evidence sufficient to establish a prima facie case. 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. The evidence set forth by CMS must be sufficient to establish a prima facie case that CMS had a legally sufficient basis to impose a remedy, such as the per instance CMP imposed in this case. In order for a petitioner to prevail, the petitioner must then prove by a preponderance of the evidence on the record as a whole that it was in substantial compliance with the relevant statutory and regulatory provisions. Hillman Rehabilitation Center, DAB No. 1611, aff'd Hillman Rehabilitation Center v. U.S. Dept. of Health and Human Services, No. 98-3789 (D.N.J. May 13, 1999).

IV. 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, in italics, as a separately numbered heading. I explain each Finding in detail.

1. Summary affirmance of CMS's determination to impose a per instance CMP is appropriate in this case.

CMS has submitted a motion for summary affirmance asserting that there are no genuine issues of material fact in this case. Petitioner asserts that issues of material fact exist in the case necessitating an in-person, evidentiary hearing. Petitioner argues that to require it to respond with extensive briefing places an unfair and expensive burden on it. Petitioner, however, also moves for summary affirmance, arguing that, in its motion, CMS failed to establish that a deficient practice existed.

Summary disposition is appropriate only where a disposition is made based on material facts which are not in dispute. Summary disposition cannot be made where material facts are contested, because due process considerations require an evidentiary hearing to decide contested facts. While inferences made from facts which are averred to support a motion must be made in a manner most favorable to the party that opposes the motion, it is not sufficient for a party simply to state that it disputes allegations of fact in order to avoid possible entry against it of summary disposition. That party must describe the asserted facts credibly in order to establish a dispute.

I believe that it is appropriate to decide this case based on the parties' motions and briefs. In its response and sur-reply, Petitioner did not offer any affirmative evidence or even argument which credibly established a genuine dispute as to the facts, nor did it demonstrate that the disputed facts it alleged had a material bearing on the outcome of this case. See Southfield Medical Clinic, DAB CR667 (2000); Melvin C. Murphy, M.D., P.C., DAB CR590 (1999). Moreover, as I find and discuss below, CMS demonstrated, and Petitioner did not credibly deny, that no genuine issues of material fact exist with respect to the deficiency at issue or the amount of the CMP.

Finally, I deny Petitioner's motion for "summary affirmance," as I find below that CMS did establish that a deficiency existed.

2. Petitioner failed to comply substantially with a federal participation requirement, causing actual harm to a resident.

CMS alleges that Petitioner caused actual harm to one of its residents, Antonia B., when on at least two occasions a nursing employee transferred Antonia B. from her bed to a geri chair using a one-person transfer method where her care plan required a two- to three-person assist to provide adequate support and positioning. CMS further alleges that the transfer on both occasions resulted in injury to Antonia B.'s head causing actual harm. The record supports CMS's allegations, and Petitioner has not presented any affirmative evidence or argument that would establish a genuine dispute as to the facts or would materially affect the outcome of the case.

In June 2000, Antonia B. was an 89- or 90-year old⁽²⁾ resident of Petitioner's facility. CMS Ex. 3, at 3; CMS Ex. 11; CMS Ex. 13, at 1. Antonia B.'s medical conditions included urinary tract infection, urosepsis, hypertension, peripheral vascular disease, hysterectomy, osteomyelitis, senile dementia, tympanosclerosis, hypothyroidism, osteoporosis, anemia and a left distal femur fracture. CMS Ex. 13, at 1 - 3; CMS Ex. 7, at 2; CMS Ex. 11; CMS Ex. 3, at 3. Antonia B.'s care plan cautioned Petitioner's staff that Antonia B. had "[i]mpaired physical mobility functions secondary to physical deconditioning associated with recent left femur fracture." CMS Ex. 13, at 3. Her care plan further cautioned Petitioner's staff to "[p]rovide and maintain safe environment during transfer from bed to cardiac chair (geri chair) - vice versa (resident is total dependence with transfer). Support the affected leg (left side) during transfer. Transfer resident with 2-3 physical caregivers to provide adequate transfer motion." Id.

On June 23, 2000, one of Petitioner's nursing employees, Yolanda B., transferred Antonia B. from her bed to a geri chair using a one-person transfer method. Following the transfer, Yolanda B. noticed Antonia B. was bleeding from her head. CMS Ex. 14, at 1; CMS Ex. 16, at 1. Yolanda B. noted that there was no blood on Antonia B.'s bed linen. Id. Antonia B.'s physician, who examined her on June 23, 2000, noted that "[s]he struck the back of her head resulting in approximately 1.5 - 2 cm puncture type laceration to the posterior scalp . . . [r]esident is also to be sent to the hospital to receive staples to the posterior scalp laceration." CMS Ex. 11. At the hospital, four staples were placed in Antonia B.'s head to close the scalp laceration. CMS Ex. 12, at 4.

It is apparent from my review of contemporaneous documentation surrounding this incident that Petitioner's staff's assumption was that Antonia B.'s injury was caused by her transfer. In investigating the incident, two of Petitioner's registered nurses surmised that the "G-chair 'head' is composed of bar (bracket side to side). This may 'cause' the laceration of resident (sic) head," and they noted that Yolanda B. "transferred resident by herself instead of two physical assist as instructed." CMS Ex. 16, at 3. In an incident report, it was noted that "Yolanda . . . stated she was aware that this resident requires multiple staff members to transfer her out of bed." Id. at 2. Moreover, in a corrective action form directed at Yolanda B. after this incident, Petitioner's nursing administrator noted that Yolanda B. "failed to provide and maintain [a] safe environment during transfer activity that led to laceration of the head of [Antonia B.]. You're well aware and [have] been told by other co-workers not to transfer resident by 1 person yourself." CMS Ex. 18, at 1. Yolanda B. was also told that "Further re-occurrence of any 'compromise' residents safety may result in disciplinary action up to including employment termination." Id.

On June 26, 2000, three days after Antonia B.'s first injury, Antonia B. suffered a hematoma and a gash in the back of her head when another nursing employee, Louise W., transferred Antonia B. from her bed to a geri chair, again using a one-person transfer method. CMS Ex. 3, at 4; CMS Ex. 7, at 3; CMS Ex. 12, at 4; CMS Ex. 15. Immediately following the incident, Louise W. admitted to a member of Petitioner's staff that she had transferred Antonia B. using a one-person cradle method, and noted that there was no blood on the sheet or on the pillow. CMS Ex. 14, at 4; CMS Ex. 15, at 1, 3 - 4. In a written statement dated June 26, 2000, Louise W. admitted that she alone transferred Antonia B., even though on June 24, 2000, she had been told that Antonia B. was to be a two-person transfer because of her prior injury. CMS Ex. 15, at 3. Louise W. asserted that she did this because none of her co-workers were available to assist her. Id. Louise W. also stated that she did not see any blood on her clothes or Antonia B.'s pillow after she put Antonia B. in her chair and only saw blood when she began combing Antonia B.'s hair. Id. at 3 - 4. Initially Louise W. stated she believed the bleeding was from the old injury and due to pressure from being lifted. Id. at 4. However, she was later told it was a new injury. Id. Antonia B. was again sent to the hospital where she received two staples in the left side of her head to close the laceration. CMS Ex. 14, at 4.

After the June 26, 2000 incident, a police report was filed alleging that Petitioner either abused or neglected Antonia B, resulting in the two incidents. CMS Ex. 12. The police determined that there were no signs of criminal neglect or abuse regarding these two incidents. CMS Ex. 9. However, the police determined that the techniques used to move Antonia B. were poor, in that she had very fragile skin and advanced bone density deterioration. Id. The police determined that "two different CENAs had handled the resident improperly causing the cuts on 06-23-00 and 06-25-00." CMS Ex. 10, at 2.

Nursing facilities must ensure that each of their residents receives adequate supervision and assistive devices to prevent accidents. 42 C.F.R. � 483.25(h)(2). To determine compliance with this regulation, "the relevant inquiry is whether Petitioner's supervision (of whatever nature and whatever degree) was 'adequate' for the resident's situation." Heath Nursing and Convalescent Center, DAB CR610, at 4; Woodstock Care Center, DAB No. 1726 (2000). The regulation does not amount to strict liability, as an element of reasonableness is inherent in the regulation's requirements. Woodstock, DAB No. 1726. To ensure adequate supervision, a facility is not required to do the impossible or to be a guarantor against unforeseeable occurrences, but it is required to do everything in its power to prevent accidents. Koester Pavilion, DAB No. 1750 (2000). I find that Petitioner did not do so here.

Although Petitioner appropriately identified that Antonia B. was at risk for accidents due to her impaired physical mobility, and did care plan to provide and maintain a safe environment during transfer (CMS Ex. 13, at 3), it is apparent that Petitioner did not effectively implement adequate procedures to ensure that the care plan was followed, leading me to conclude that Petitioner was not in substantial compliance with the relevant participation requirement on the dates in question. See Fairfax Nursing Home, Inc., DAB No. 1794, at 19 (2001). In this case, the facts show that Antonia B. did not receive adequate supervision and assistance devices on two occasions, June 23 and June 26, 2000.⁽³⁾ On those dates, two separate nursing employees failed to follow Antonia B.'s care plan regarding transfer. Both nursing employees admitted that they knew Antonia B. required a two- to three-person transfer, but transferred her without such assistance. Moreover, after each transfer, it was discovered that Antonia B. had injured her head in such a way that she had to go to the emergency room where staples were placed in her head to close the wounds. Despite Petitioner's assertions that there is no definite proof that the nursing employees' transfers of Antonia B. on the dates in question led to her injuries (see P. Reply Br., at 2 - 3, where Petitioner suggests that the injuries could have been caused by a bar apparatus attached to the back of Antonia B.'s chair, could have occurred following the transfer, could have occurred with a two- or three-person assist, or, on June 26, 2000, could have been caused inadvertently by the nursing employee's fingernail), I find that a reasonable inference can be made from contemporaneous documentation, especially given the result of the police investigation, that Antonia B.'s injuries came about as a result of her transfers, causing her actual harm.

Petitioner, however, argues that because it had identified Antonia B. as at risk for accidents, had care planned to address that risk, hired certified employees, properly trained and evaluated its employees, and responded appropriately when the incidents occurred, that it was not deficient in complying with 42 C.F.R. � 483.25(h)(2). P. Br. at

4 - 6; P. Reply Br. at 5. Specifically, Petitioner asserts that it should not be cited as out of compliance because its nursing employees chose to transfer Antonia B. using a method that their nursing supervisors did not approve, and a method the nursing employees found to be simpler and safer (although I note that Petitioner has offered absolutely no evidence to substantiate that a one-person transfer method would be a simpler or safer method or to indicate in the record where Yolanda B. or Louise W. have asserted that the one-person transfer method was simpler or safer). See P. Reply Br. at 2, 4. I find Petitioner's argument to be unpersuasive. The measures Petitioner took to comply with the regulation did not work here. Had Petitioner effectively trained and monitored its employees regarding transfers, and especially had it made sure that an adequate number of staff were available to assist with Antonia B.'s transfers, Antonia B. would not have been transferred by a method not recognized in her care plan. I agree with CMS that whether these employees were not properly trained, whether they were unaware of the care plan, or whether they had a practice of ignoring the care plan, Petitioner should have identified that a problem existed and taken immediate measures on a facility-wide basis to eliminate the problems before they caused harm to a resident.

Petitioner argues that CMS must show a deficient facility practice that violates the requirement and is repeated, sustained and egregious and results from a systemic failure on the part of the facility to comply with program requirements, not just the isolated conduct of two employees acting outside facility policies and procedures. P. Br. at 4 - 5; P. Reply Br. at 5. Petitioner has not supported its assertions with citation to the statute or regulation or referenced any case law. The regulatory standard is that a Petitioner must ensure that each resident receives adequate supervision and assistance devices to prevent accidents. It is a violation of the requirement if, in any case, a resident fails to receive such adequate supervision and assistance devices, and I have so found in this case. Moreover, here I note that where two employees, within a three-day period, independently failed to follow Antonia B.'s care plan, causing her harm, it could even be said that a systemic problem did exist that Petitioner was deficient in addressing.

Petitioner argues that to make a deficiency determination strictly on the occurrence of an event, without taking into consideration a nursing facility's actions both before and after the event, elevates the regulatory requirements from "substantial compliance" to "strict liability," which Petitioner asserts is beyond the intent of the regulations. P. Reply Br. at 6. Again, I disagree. The issue here is not about strict liability or about whether Petitioner's actions before and after the incidents were generally reasonable in light of compliance with the regulation, but, instead, whether Petitioner provided "adequate supervision" in this instance to prevent accidents. Any element of "reasonableness" goes only to whether, in this instance, Petitioner provided adequate supervision to prevent this resident's accident. Even looking at the actions taken by Petitioner both before and after the incidents in question, I would not find that Petitioner provided "adequate supervision," as the measures taken by Petitioner to get its employees to comply with Antonia B.'s care plan were ineffective.

Petitioner argues further that, in spite of the "temporal connection" between the two incidents, Antonia B.'s injuries were minimal and the scope of harm was limited because she did not sustain lasting harm. P. Reply Br. at 3. First, the law does not require, and Petitioner has nowhere provided support, for its assertion that the actual harm sustained by a resident must be lasting harm for an administrative law judge to uphold a finding of noncompliance. Moreover, I find to be singularly unpersuasive Petitioner's insinuation that due to the "limited" scope of Antonia B.'s injuries it should not be found noncompliant with participation requirements. I believe that two head injuries to a medically compromised 89- or 90-year old resident of a nursing facility, requiring emergency room treatment and the insertion of staples in her head, are not "minimal" harm. These injuries were serious, unacceptable, and preventable, had the employees in question transferred her in accordance with her care plan.

3. CMS is authorized to impose a $1,500 CMP, and the $1,500 CMP is reasonable.

A petitioner's failure to comply substantially with a federal participation requirement is a basis for CMS to impose remedies against that petitioner, including a per instance civil money penalty in the amount of $1,000 to $10, 000 in a case where one or more deficiencies constitute actual harm. 42 C.F.R. � 488.430; 488.438(a)(2); 488.408(d). In this case, CMS chose to impose a CMP of $1,500 against Petitioner. Petitioner has argued that the CMP is not reasonable under 42 C.F.R. � 488.438(f) because: 1) a decision regarding the basis of the imposition of the CMP has not been reached and should not have been reached without "proper adjudication of the facts. . ." and Petitioner has not had the chance to cross-examine CMS's witnesses to determine whether CMS properly applied the criteria at 42 C.F.R. � 488.438(f) (P. Br. at 11); and 2) CMS relied on Petitioner's history of noncompliance and Petitioner should be able to appeal a deficiency finding from a prior survey which was considered by CMS in making its determination as to the amount of the CMP (P. Br. at 11 - 12, citing 42 C.F.R. � 488.408(g)(1), which states that a facility may appeal a certification of noncompliance leading to an enforcement remedy).⁽⁴⁾

With regard to Petitioner's first argument, I have found that an in-person hearing is not indicated in this case, and I have found further that Petitioner was noncompliant with a participation requirement causing actual harm, thus authorizing CMS to impose remedies against Petitioner, including, as here, a per instance CMP. With regard to Petitioner's second argument, I discuss and dismiss it below, at Finding 4. Moreover, Petitioner has presented no evidence to refute CMS's evidence that the $1,500 CMP is reasonable in this case.

I find that the amount of the CMP assessed against Petitioner by CMS is reasonable. I am not obliged to presume that CMS has correctly assessed the evidence and factors in setting the amount of a CMP. Instead, as the hearing before an administrative law judge is a de novo hearing, I am bound to make an independent determination as to whether the amount of a CMP set by CMS is reasonable based on the evidence. See Emerald Oaks, DAB CR801 (2001); Careplex of Silver Spring, DAB No. 1683, at 18 (1999).

In my independent review of the relevant regulatory factors set forth at 42 C.F.R. � 488.438(f) and 42 C.F.R. � 488.404, I find that: Petitioner has not argued that it its financial condition is such that it cannot pay a $1,500 CMP (42 C.F.R. � 488.438(f)(2)) and CMS has submitted unrebutted evidence that Petitioner's financial condition was adequate to pay it (CMS Ex. 23; CMS Br. at 23); Petitioner is culpable in this instance, for it did not effectively provide Antonia B. adequate supervision and assistance devices to prevent accidents, resulting in actual harm to her (42 C.F.R. � 488.438(f)(4)); and Petitioner's deficiency was serious, leading to isolated actual harm (42 C.F.R. � 488.404(b) and 42 C.F.R. � 488.438(f)(3)). These factors alone are enough to lead me to conclude that the $1,500 CMP, which is at the very low end of the range of per instance CMPs allowed by the regulations, is reasonable. Moreover, Petitioner has presented absolutely no evidence to refute the reasonableness of the amount of the CMP.

In making my decision, I have not considered Petitioner's history of noncompliance (42 C.F.R. � 488.438(f)(1); 42 C.F.R. � 488.404(c)(2)), as I was able to find the CMP to be reasonable without making such a determination.

4. Petitioner cannot appeal a deficiency from a prior survey cycle where no remedy was imposed, even though the deficiency was considered by CMS in computing the amount of the CMP.

Petitioner argues that it should be able to appeal a deficiency from a prior survey cycle, even though a remedy was not imposed based on that deficiency, where the deficiency forms part of the basis for CMS's decision to impose a CMP. Specifically, Petitioner asserts that it should be able to appeal a "G" level violation from a survey of November 10, 1999, because CMS included it in its computation of the CMP in this case in considering Petitioner's history of noncompliance under the regulatory factors. P. Br. at 9 - 11; P. Reply Br. at 7 - 11.

I note first that in my de novo consideration of the CMP in this case I did not need to reach this issue, as I was able to find that the CMP was reasonable without review of Petitioner's history of noncompliance. However, in reviewing Petitioner's arguments, I note that a petitioner may appeal only from initial determinations that result in the imposition of a remedy, such as a CMP. 42 C.F.R. � 498.3. Thus, a petitioner is precluded from appealing deficiencies that are not the basis for a remedy CMS imposed, such as the deficiencies associated with Petitioner's November 10, 1999 survey. Moreover, I agree with CMS that where CMS did not consider findings from the November 10, 1999 survey when deciding to impose a remedy on Petitioner, but only considered the deficiency set forth in the August 17, 2000 survey, no hearing rights exist. Thus, there is no legal authority permitting Petitioner to appeal deficiency findings from the November 10, 1999 survey because it was from a survey cycle unrelated to the one at issue here, and is only relevant in considering the past compliance history of the facility (which, in any event, I have not considered in this case).

Richard J. Smith

Administrative Law Judge

1. When this case was initially docketed, CMS was referred to as the Health Care Financing Administration or HCFA. HCFA has since been renamed the Centers for Medicare & Medicaid Services or CMS. When I refer to anything in the record previously submitted as the Health Care Financing Administration or HCFA, I will refer to it as the Centers for Medicare & Medicaid Services or CMS.

2. It is not clear from the record whether Antonia B. was 89 or 90 years old in June 2000. However, whether Antonia B. was 89 or 90 at the time of these incidents is irrelevant to my decision in this case.

3. In making my decision I am not considering any documentation submitted or conclusions reached during the informal dispute resolution process.

4. Petitioner also raised three issues with regard to the per instance CMP, which it noted were beyond my ability to decide. They are: 1) Whether the rule authorizing the imposition of a per instance CMP was validly promulgated under the Administrative Procedure Act authorizing CMS to create a per instance CMP; 2) whether the per instance CMP rule violates the Act; and 3) whether the Department of Health and Human Services acted in an arbitrary and capricious manner in failing to consider relevant factors necessary to support a reasonable basis for its action when it neglected to adequately consider the regulations' impact on nursing homes and offered no evidence that it attempted to find less costly alternatives. P. Reply Br. at 12. Petitioner is correct that these issues are beyond my authority to decide.