SUBJECT:

Britthaven of Wrightsville,

Petitioner,

Centers for Medicare & Medicaid Services.

DECISION

Petitioner, Britthaven of Wrightsville, was not in substantial compliance with Medicare and Medicaid conditions of participation governing long-term nursing home facilities from May 10, 2002 to July 1, 2002. A per instance civil money penalty (CMP) of $5,000 is reasonable.

I. PROCEDURAL HISTORY

Petitioner, located in Wilmington, North Carolina, is certified to participate in the Medicare program as a skilled nursing facility (SNF) and in the state Medicaid program as a nursing facility (NF). Petitioner requested a hearing by letter dated August 9, 2002, to challenge the findings of a complaint survey of Petitioner's facility completed by the North Carolina Department of Health and Human Services, Division of Facility Services, Licensure and Certification Section (the state agency) on May 23, 2002, which resulted in a declaration of immediate jeopardy. Based on recommendations of the state agency the Centers for Medicare & Medicaid Services (CMS), imposed a per instance CMP of $7,500 which also causes loss of Petitioner's nurse aide training program, denial of payment for new admissions effective August 23, 2002, and termination of Petitioner's participation agreement effective November 23, 2002. It was determined on a revisit survey on July 11, 2002, that Petitioner achieved substantial compliance effective July 1, 2002, and the proposed denial of payment for new admissions and termination were cancelled. CMS Exhibits (Exs.) 8 & 9.

The case was assigned to me for hearing and decision on August 21, 2002, and on that date a Notice of Case Assignment and Prehearing Case Development Order was issued at my direction. The parties waived their right to oral hearing and agreed to have this case decided on the written record. Status Report of the Parties, October 28, 2002; Petitioner's Motion for Waiver of Oral Hearing, November 14, 2002. A briefing schedule was established by my Order of November 8, 2002, and the motion for waiver of oral hearing was granted by my Order of December 9, 2002.

The parties filed opening and reply briefs. CMS offered CMS Exs. 1 through 19 ⁽¹⁾, without objection by Petitioner, and those exhibits are admitted. Petitioner offered Petitioner's Exhibits (P. Exs.) 1 through 5, without objection by CMS, and those exhibits are admitted. Petitioner also submitted documents marked as Attachments 1 through 5, to its opening brief. CMS filed no objection to the admissibility of Petitioner's attachments (P. Att.) 1 and 3 through 5, and they are also admitted as evidence. CMS did object to P. Att. 2, a hand-written statement signed by Mary Haggins, CNA, dated May 22, 2002, on Comfort Inn stationary. CMS Reply at 5, fn. 2. CMS objects on grounds that the statement is not in the form of a declaration or affidavit as required by my Order of November 8, 2002. CMS's objection is well taken, the statement is not sworn and does not reflect it was given with awareness that a false statement might subject one to a charge of perjury. Therefore, the statement will not be given the weight I might give testimony, an affidavit, or a declaration. Nevertheless, because the statement is relevant and there is no objection to its authenticity, it is admitted as evidence. Petitioner submitted two documents attached to its response brief and marked as attachments A and B. P. Att. A and B are also admitted as evidence.

II. FINDINGS OF FACT AND CONCLUSIONS OF LAW

A. FINDINGS OF FACT

The following findings of fact are based upon the exhibits admitted. Citations to exhibit numbers related to each finding of fact may be found in the analysis section of this decision if not indicated here.

1. Petitioner is located in Wilmington, North Carolina and is certified to participate in the Medicare program as a SNF and in the state Medicaid program as a NF.

2. Petitioner requested a hearing by letter dated August 9, 2002, to challenge the findings of a complaint and extended survey of Petitioner's facility completed by the state agency on May 23, 2002, which resulted in a declaration of immediate jeopardy.

3. It was determined on a revisit survey on July 11, 2002, that Petitioner achieved substantial compliance effective July 1, 2002.

4. Petitioner was cited with violations of 42 C.F.R. �� 483.25 (F Tag 309); 483.25(h)(2) (F Tag 324); 483.75(e)(8) (F Tag 497); and 483.75(o)(2) & (3) (F Tag 521). The violation of section 483.25(h)(2) (F Tag 324) was alleged to present immediate jeopardy.

5. Facts related to F Tags 309 and 324:

a. Resident 1 was admitted to Petitioner's facility on May 10, 2002.

b. Resident 1 attempted to elope on May 10, 2002, shortly after his admission to Petitioner's facility.

c. Resident 1 was assessed by Petitioner's staff upon admission and a nursing summary was prepared on that day which detailed his activities and behaviors.

d. Resident 1 was assessed as being at high risk for wandering and elopement and an electronic "Wander Guard" system was implemented to prevent elopement as well as some other interventions.

e. The formal assessment document for Petitioner was initiated on May 18, 2002, after completion of the required seven-day observation period, and the formal assessment was not required to be completed in less than 14 days after it was initiated.

f. Petitioner had a policy that required completion upon admission of a "resident care guide" for a resident assessed to be at risk for wandering.

g. No "resident care guide" was produced by Petitioner for Resident 1.

h. Petitioner has produced no documented initial care plan for Resident 1.

i. It was discovered on May 23, 2002 at 4:23 AM, that Resident 1 was not in Petitioner's facility.

j. Appropriate notifications of the Administrator, Director of Nursing (DON), police, treating physician, and guardian were made.

k. Resident 1's Wander Guard anklet or bracelet was found in a bag in his closet about 10:00 AM on May 22, 2002.

l. At 7:00 PM on May 22, 2002, a neighbor of Petitioner's facility notified staff that he spotted Resident 1 on the road to the facility and the resident was returned to the facility.

m. Resident 1 had previously removed his ankle alert bracelet but Petitioner elected not to use a wire or metal ankle alert bracelet to prevent injury to Petitioner.

n. Resident 1 said that he just punched numbers on the door security device until the green light came on and then he left.

o. Upon Resident 1's return to the facility, he was given one-on-one supervision until his discharge later on May 23, 2002.

6. Facts related to F Tag 497:

a. Nurse Aide 1 began employment with Petitioner on May 10, 2001.

b. Nurse Aide 2 began employment with Petitioner on May 11, 1999.

c. Nurse Aide 3 began employment with Petitioner on March 29, 1995.

d. In-service training records reviewed by the surveyors, show that Aide 1 only had 20 minutes training during the period May 10, 2001 to May 10, 2002; Aide 2 only had 20 minutes training during the period May 11, 2001 to May 11, 2002; and Aide 3 only had 5 hours and 45 minutes training during the period May 10, 2001 to May 10, 2002.

7. CMS determined to impose a per instance CMP of $7,500 based upon the facility's past history of elopement, the elopement cited in this survey, and the potential for harm faced by Resident 1 during his elopement.

8. CMS presented no evidence related to Petitioner's history of a citation related to an elopement.

9. Petitioner does not deny that it was previously cited for "elopement issues."

10. There is no evidence of an inability to pay a CMP.

11. Resident 1's elopement was an extremely serious incident which presented immediate jeopardy to the demented and delusional resident.

B. CONCLUSIONS OF LAW

1. Petitioner's request for hearing was timely and I have jurisdiction.

2. The parties waived oral hearing.

3. Petitioner did not waive its right to hearing as to any issues related to the survey which ended May 23, 2002.

4. CMS did not impose the CMP in this case based solely upon the deficiency alleged to have presented immediate jeopardy for Resident 1.

5. Petitioner violated 42 C.F.R. � 483.25 (F Tag 309) by failing to produce evidence of a documented initial care plan that Petitioner's staff could use to deliver necessary care and services related to Resident 1's high risk for wandering and elopement.

6. Petitioner violated 42 C.F.R. � 483.25(h)(2) (F Tag 324) by failing to provide adequate supervision or assistance devices to minimize the risk of Resident 1's elopement, given the known high risk for elopement and that interventions in place were minimally effective.

7. The declaration that there was immediate jeopardy for Resident 1 is not clearly erroneous.

8. Petitioner violated 42 C.F.R. � 483.75(e)(8) (F Tag 497) by failing to document required in-service training of 12 hours or more for Nurse Aides 1 and 2.

9. CMS has not made a prima facie showing of a violation of 42 C.F.R. � 483.75(e)(8) with regard to Nurse Aide 3 because the surveyors do not allege insufficient in-service training during the period marked by her hiring anniversary date.

10. Petitioner has not rebutted the CMS prima facie showing with respect to Nurse Aides 1 and 2 or established an affirmative defense.

11. CMS has failed to make a prima facie showing of a violation of 42 C.F.R. � 483.75(o)(2) (F Tag 521).

12. A per instance CMP of $7,500 is not reasonable, and it is, therefore, reduced to $5,000, which is reasonable given the factors specified at 42 C.F.R. � 488.438(f).

III. ANALYSIS

A. ISSUES

The issues in this case are:

i. Whether there is a basis for the imposition of an enforcement remedy; and,

ii. Whether the remedy imposed is reasonable.

B. APPLICABLE LAW

Petitioner is a long-term care facility participating in both the Medicare program as a SNF and in Medicaid as a NF. The statutory and regulatory requirements for participation by a long-term care facility are found at sections 1819 and 1919 of the Social Security Act (Act), and at 42 C.F.R. Part 483. Sections 1819 and 1919 of the Act vest the Secretary of Health and Human Services (Secretary) with authority to impose CMP's against a long-term care facility for failure to comply substantially with federal participation requirements.

Pursuant to the Act, the Secretary has delegated to CMS and the states the authority to impose remedies against a long-term care facility that is not complying substantially with federal participation requirements. Facilities that participate in Medicare may be surveyed on behalf of CMS by state survey agencies in order to determine whether the facilities are complying with federal participation requirements. 42 C.F.R. �� 488.10-488.28. The regulations contain special survey conditions for long-term care facilities. 42 C.F.R. �� 488.300-488.335.

Pursuant to 42 C.F.R. Part 488, a state or CMS may impose a per instance or per day CMP against a long-term care facility when a state survey agency concludes that the facility is not complying substantially with federal participation requirements. 42 C.F.R. �� 488.406; 488.408; 488.430. The regulations specify that a CMP that is imposed against a facility on a per day basis will fall into one of two broad ranges of penalties. The upper range of CMP, of from $3,050 per day to $10,000 per day, is reserved for deficiencies that constitute immediate jeopardy to a facility's residents, and in some circumstances, for repeated deficiencies. The lower range of CMP, from $50 per day to $3,000 per day, is reserved for deficiencies that do not constitute immediate jeopardy, but either cause actual harm to residents, or cause no actual harm, but have the potential for causing more than minimal harm. There is only a single range of $1,000 to $10,000 for a per instance CMP. 42 C.F.R. �� 488.408; 488.438.

Pursuant to 42 C.F.R. � 488.301, "(i)mmediate jeopardy means a situation in which the provider's noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident." (emphasis in original). Further, "(s)ubstantial compliance means a level of compliance with the requirements of participation such that any identified deficiencies pose no greater risk to resident health or safety than the potential for causing minimal harm." Id. (emphasis in original).

When a penalty is imposed and appealed, CMS must make a prima facie case that the facility has failed to comply substantially with federal participation requirements. To prevail, a long-term care facility must overcome CMS's showing by a preponderance of the evidence. Batavia Nursing and Convalescent Center, DAB No. 1904 (2004); Batavia Nursing and Convalescent Inn, DAB No. 1911 (2004); 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. May 13, 1999).

The Act and regulations make a hearing before an administrative law judge (ALJ) available to a long-term facility against whom CMS has determined to impose a civil money penalty. Act, section 1128A(c)(2); 42 C.F.R. �� 488.408(g); 498.3(b)(12), (13). The hearing before an ALJ is a de novo proceeding. Anesthesiologists Affiliated, et al, DAB CR65 (1990), aff'd, 941 F2d. 678 (8^th Cir. 1991). A facility has a right to appeal a "certification of noncompliance leading to an enforcement remedy." 42 C.F.R. � 488.408(g)(1); see also 42 C.F.R. �� 488.330(e) and 498.3. However, the choice of remedies by CMS or the factors CMS considered when choosing remedies are not subject to review. 42 C.F.R. � 488.408(g)(2). A facility may only challenge the scope and severity level of noncompliance found by CMS if a successful challenge would affect the amount of the CMP that could be collected by CMS or impact upon the facility's nurse aide training program. 42 C.F.R. �� 498.3(b)(14) and (d)(10)(i). CMS's determination as to the level of noncompliance "must be upheld unless it is clearly erroneous." 42 C.F.R. � 498.60(c)(2). This includes CMS's finding of immediate jeopardy. Woodstock Care Center, DAB No. 1726, at 9, 38 (2000), aff'd Woodstock Care Center v. U.S. Dept. of Health and Human Services, 2004 FED App. 0095P (6^th Cir.).

The Departmental Appeals Board (Board) has long held that the net effect of these regulations is that a provider has no right to challenge the scope and severity level assigned to a noncompliance finding, except in the situation where that finding was the basis for an immediate jeopardy determination. See, e.g., Ridge Terrace, DAB No. 1834 (2002); Koester Pavilion, DAB No. 1750 (2000).

C. DISCUSSION

This case arises from a complaint and extended survey conducted at Petitioner's facility on May 23, 2002. The complaint was made by the Petitioner through its social worker on May 22, 2002, and was a self-report of the elopement of Resident 1 on May 22, 2002. CMS Ex.1, at 3-4. The survey was conducted by Carol Jenkins of the state agency (CMS Ex. 16), and the results of the survey were recorded in the Statement of Deficiencies (CMS 2567L) (SOD) with a completion date of May 23, 2002, as amended June 10, 2002. CMS Ex. 3. Petitioner was cited with violations of 42 C.F.R. �� 483.25 (F Tag 309); 483.25(h)(2) (F Tag 324); 483.75(e)(8) (F Tag 497); and 483.75(o)(2) & (3) (F Tag 521). The violation of section 483.25(h)(2) (F Tag 324) was alleged to present immediate jeopardy. The other deficiencies were all cited as presenting the potential for more than minimal harm with no actual harm. Id. Petitioner submitted a plan of correction dated July 1, 2002, that appears in the right column of the copy of the SOD at CMS Ex. 6. Petitioner's plan of correction was found acceptable (CMS Ex. 7), and based on a revisit survey it was determined that Petitioner was in substantial compliance with regulatory requirements as of July 1, 2002 (CMS Ex. 8).

In its August 9, 2002 request for hearing, Petitioner disputes each of the deficiencies cited in the SOD and the reasonableness of the CMP. CMS argues in its opening brief that I should grant summary judgment in its favor as to all deficiencies except the alleged violation of 42 C.F.R. � 483.225(h)(2) (F Tag 324) as Petitioner only referred to that deficiency citation in the parties' Joint Statement Of Issues Presented For Hearing And Stipulations dated November 4, 2002. CMS Opening Brief (CMS Brief) at 6. Petitioner opposes the CMS motion for partial summary judgment on grounds that there was no intent to waive review as to any alleged deficiency. Petitioner requested in the alternative that it be granted summary judgement as to all cited deficiencies except F Tag 324 on grounds that it was the only deficiency cited by the state agency as the basis for the imposition of an enforcement remedy. Petitioner Response Brief (P. Response) at 2-3. Having reviewed the contentions of the parties, I conclude that Petitioner did preserve the right to challenge each of the deficiencies cited in the SOD. Further, while Petitioner is correct that the state agency seemed to base the enforcement remedies it recommended to CMS upon F Tag 324 (CMS Ex. 2), CMS did not appear to so limit itself. CMS correspondence indicates that CMS based its decision as to which remedies to impose based on all the findings of the May 23, 2002 survey (CMS Ex. 4, at 2). Accordingly, the cross-motions for partial summary judgment are denied. Further, I find that all deficiencies cited in the SOD are properly before me for disposition on the merits. The parties have presented evidence related to and fully briefed all alleged deficiencies and this case is ripe for decision.

1. The alleged violation of 42 C.F.R. � 483.25 (F Tag 309).

The general quality of care standard is established by 42 C.F.R. � 483.25, which provides:

Each Resident must receive and the facility must provide the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the comprehensive assessment and plan of care.

The surveyors allege in the SOD that the regulatory requirement was not satisfied because the "facility failed to provide an initial care plan for one . . . resident [Resident 1], who was admitted to the facility with an elopement history." CMS Ex. 6, at 1. Specifically, the surveyors allege that upon Resident 1's admission to Petitioner's facility, his records, including a hospital discharge summary dated May 10, 2002, clearly indicated that Resident 1 was an elopement risk requiring close monitoring. The surveyors allege that a policy or procedure of Petitioner titled "Wandering Risk Potential Protocol" required that a resident care guide be completed on admission with interventions related to the resident's risk for wandering addressed in that guide. CMS Ex. 14, at 3. The surveyors allege that they could not find a resident care guide for Resident 1 and none was produced by the facility. Id., at 1-2. In its plan of correction (right column CMS Ex. 6), Petitioner does not deny the facts alleged by the surveyors, but addresses corrective actions taken after this matter was brought to the attention of facility staff. ⁽²⁾ Id.

Petitioner argues in its opening brief that Resident 1 was admitted to the facility on May 10, 2002, that he was assessed at that time, and that a nursing summary was prepared on that day which detailed his activities and behaviors. The resident was assessed as being at risk for wandering and an electronic "Wander Guard" system was implemented to prevent elopement on May 10, 2002. The formal assessment document for Petitioner was initiated on May 18, 2002, after completion of the required seven-day observation period, and the formal assessment was not required to be completed in less than 14 days after it was initiated. Petitioner's Opening Brief (P. Brief) at 4. Petitioner further argues in its response brief that the failure to follow its own policy by having a resident care guide for Resident 1 at the time of the survey, does not constitute a violation of the quality of care requirement and it had done all it was required to do. P. Response at 4-5.

CMS urges me to find Petitioner in violation on the grounds cited by the surveyors. CMS also discusses in detail the importance of initial care planning noting that the importance of initial care planning was recognized by Petitioner because Petitioner adopted the policy requiring the plan in the form of a resident care guide. CMS Brief at 8-11; CMS Reply Brief (CMS Reply) at 1-3.

There is no dispute that Resident 1 was admitted to Petitioner's facility on May 10, 2002, and that he was at risk for elopement. The "Wandering Risk Potential Protocol" that the surveyors allege Petitioner violated was a section in Petitioner's "Nursing Policy Manual," revised March 16, 2001, at page 67. CMS Ex. 14, at 3. The stated purposes of the protocol were to prevent a resident's elopement, to plan for a resident's well-being, and to determine appropriate placement. Id. The procedure specifies that a "Risk Assessment for Wandering" be completed on admission to the facility. If the resident scores greater than 12 on the assessment, then the following would be done: (a) a "Potential Wandering Resident Information Fact Sheet" would be completed; (b) an initial care plan for the resident, including measurable goals and interventions to ensure safety, would be placed on the resident's medical record in the "Nurses Note" section; (c) a "Behavior Observation Profile" or "Documentation of Behavior" would be initiated for recording wandering or attempted elopements; (d) a "Resident Care Guide" would be completed on admission with interventions related to the resident's risk for wandering addressed; (e) a risk assessment would be reviewed quarterly; and (e) a change in behavior, wandering, or an elopement attempt would trigger a new risk assessment. CMS Ex. 14, at 3-4. Resident 1's records show that he was discharged from Dorothy Dix Hospital on May 10, 2002, with diagnosis of chronic paranoid schizophrenia, dementia with delusions, a schizoaffective disorder, and some physical ailments. He was admitted to Petitioner's facility on May 10, 2002. On admission to Petitioner's facility a nursing summary was completed reflecting an assessment of Resident 1's activities of daily living, hearing, vision, communication, orientation, including a notation that he would wander and had an anklet and required monitoring. The hand-written note indicates he attempted to elope shortly after his admission on May 10, which resulted in the anklet being applied. P. Ex. 3, at 1-3. The record also contains a "Potential Wandering Resident Information" sheet and a "Risk Assessment - Wandering," both dated May 10, 2002. Id., at 4-5.

My review of the evidence shows that Petitioner's staff did assess Resident 1 upon his admission to the facility on May 10, 2002. As a result of the assessment, including information available to Petitioner upon Resident 1's admission, it was clear that Resident 1 was at risk for wandering and elopement. Indeed, the "Risk Assessment - Wandering" completed for Resident 1 on May 10, 2002, and admitted as P. Ex. 3, at 5, reflects that Petitioner's staff assessed Resident 1 as being at "high risk" for wandering. Staff's assessment shows that Resident 1 was disoriented most of the time, very agitated daily, ambulatory, demented with cognitive loss, had difficulty communicating and occasional episodes of confusion. Id. The record also reflects that Petitioner did begin the formal assessment and planning process using the Resident Assessment Protocol (RAP) and Minimum Data Set (MDS). Id., at 6-33.

While there is good evidence that Petitioner's staff did an initial assessment of Resident 1 on his admission and that a formal assessment was on-going, the evidence that there was a documented initial plan of care is what is lacking in this case. The parties' discussion misses the point of this alleged violation. The gist of the deficiency, as alleged by the surveyors, is that they found no initial care plan for Resident 1. CMS Ex. 6, at 1. The surveyor's looked at Petitioner's "Nursing Policy Manual" and found that there was supposed to be a "Resident Care Guide" completed on admission that would address interventions to minimize the risk associated with a resident's potential to wander. The surveyors allege that they could not find the "Resident Care Guide" for Resident 1 and they could not find the staff responsible for completing the guide - these allegations are not disputed by Petitioner. I do not read the allegations to be that the surveyors could not find a "Resident Care Guide" and, thus, there was a violation. I do read the allegation to be that the surveyors could not find evidence of a document that set out the initial care plan for Resident 1, which according to Petitioner's policy should have been in the form of a "Resident Care Guide." This is not to say that there is no evidence that Petitioner did some initial care planning for Resident 1. The hand-written note in the nursing summary indicates that after Resident 1 attempted to elope on May 10, a Wander Guard anklet was applied. The nurse also opined that Resident 1 needed supervision. P. Ex. 3, at 3. Staff also completed the resident information form for Resident 1, the clear purpose of which is to be able to identify the resident in the event of elopement. Assuming that there is evidence of an initial plan of care here, the problem identified by the surveyors is that there is no evidence that Petitioner created a document that set forth and effectuated its initial plan of care by communicating that plan to its staff in an accessible and understandable form. There is no evidence of a writing by Petitioner that sets forth for staff such guidance as to how and how often Resident 1 should be monitored/supervised, how he should be redirected if wandering or attempting elopement, whether or not his anklet needed to be checked and how often to ensure it was intact, and any other interventions that Petitioner deemed appropriate to meet Resident 1's needs for care and services related to wandering and elopement. I conclude that a violation exists because there is no evidence of a documented initial care plan that Petitioner's staff could use to deliver necessary care and services to Resident 1 related to his high risk for wandering and elopement. ⁽³⁾

The SOD reflects that this deficiency was viewed by the surveyors as an isolated incident with no actual harm but with the potential for more than minimal harm that does not amount to immediate jeopardy - scope and severity level D. State Operations Manual (SOM), section 7400E. It is not for me to review the CMS determination of scope and severity level. Nevertheless, for purposes of assessing the reasonableness of the remedy imposed, I conclude that if a clear and understandable plan of care for a resident is not readily available to staff providing care to a resident at high risk for wandering, the risk for more than minimal harm to that resident is clearly present.

2. The alleged violation of 42 C.F.R. � 483.25(h)(2) (F Tag 324).

This alleged deficiency also falls within the area of quality of care. The regulation requires, regarding the prevention of accidents, that a facility ensure that "(e)ach resident receives adequate supervision and assistance devices to prevent accidents." 42 C.F.R. � 483.25(h)(2). The specific manner by which facilities are to deliver care and services is not prescribed by the regulations. Rather, a facility is permitted to determine the means to achieve the regulatory ends. In the case of section 483.25(h)(2), the regulatory end is the prevention of accidental injury of nursing facility residents. The issue is whether the quality of the supervision or the use, or lack thereof, of assistive devices at Petitioner's facility was such that residents were subject to the risk of injury from accidental causes in their daily activities. In order to evaluate a facility's compliance with section 483.25(h), it is necessary to examine whether the facility did all it could to "prevent foreseeable accidents" or whether the facility did "everything in its power to prevent accidents." Odd Fellow and Rebekah Health Care Facility, DAB No. 1839, at 6-7 (2002), quoting Asbury Care Center at Johnson City, DAB No. 1815, at 12 (2002) and Koester Pavilion, DAB No. 1750, at 25-26 (2000). Section 483.25(h)(2) requires that a facility provide both "assistive devices" and "adequate supervision" to prevent accidents. What supervision or assistive devices are adequate depends on what kind of measures would be calculated to prevent potential accidents from occurring given the known or reasonably foreseeable risks. In Woodstock Care Center, the Board considered whether the facility had notice of or should reasonably have anticipated the risk of the kind of events that occurred and whether any reasonable means were available to prevent them without violating the residents' rights. DAB No. 1726, at 26-27. Based on the regulation and the cases in this area, CMS meets its burden to show a prima facie case if: (1) it presents evidence that an accident occurred (with or without harm to a resident); or (2) it shows the facility failed to do what it could to supervise residents or provide assistive devices to minimize risks that could lead to accidents.

The surveyors allege that Petitioner failed to provide supervision necessary to prevent the elopement of Resident 1, who had a known history of elopement and who had been assessed as at high risk for elopement. CMS Ex. 6, at 2. The surveyors allege in the SOD that the events related to Resident 1's elopement occurred on May 23, 2002. However, it is not disputed by the parties that the events recited by the surveyors actually occurred on May 22, 2002, the day before the survey. CMS Reply at 4; P. Brief at 6, fn. 2. The surveyors allege that nursing notes indicate that it was discovered on May 22, 2002, at 4:23 AM, that Resident 1 was not in the facility. Appropriate notifications of the Administrator, DON, police, treating physician, and guardian were made. Resident 1's Wander Guard anklet or bracelet was found in a bag in his closet about 10:00 AM on May 22, 2002. At 7:00 PM on May 22, 2002, a neighbor of Petitioner's facility notified staff that he spotted Resident 1 on the road to the facility and the resident was returned to the facility. The surveyor was told by a direct care giver for Resident 1 and the DON that Resident 1 had previously removed his ankle alert bracelet. The direct care giver also reported that Resident 1 said that he just punched numbers on the door security device until the green light came on and then he left. Id., at 2-4. Upon Resident 1's return to the facility, he was given one-on-one supervision until his discharge later on May 22, 2002. Id., at 3 (right column).

Petitioner argues generally that CMS has not made a prima facie showing with respect to this deficiency. To the contrary, I find that CMS did make a prima facie showing by showing that Resident 1 eloped. The issue is whether or not Petitioner has presented a legitimate defense either rebutting the prima facie case or by showing that its action or failure to act is excusable. Petitioner argues that it did everything it reasonably should to supervise Resident 1 and prevent his elopement. Petitioner cites the following interventions: Resident 1 was assessed when admitted and facility staff took precautions; staff took pictures of Resident 1 and placed them on the "Wander Board"so that he could be identified by staff as a wanderer; Resident 1 was placed on the "Wander Guard" system with an anklet that would activate a door alarm if Resident 1 attempted to exit; staff did periodic checks (May 13, 2002, staff began checking location "throughout each shift" and on May 17, 2002, hourly checks were implemented); and the facility's front door has a security lock that requires a combination be entered for it to open. P. Brief at 5. Petitioner also cites the following additional actions: Resident 1's anklet was checked daily both for placement and operation (P. Brief at 7); and, after Resident 1 removed his anklet the first time, the manufacturer was consulted but alternative metal and wire anklets, which might have injured Resident 1, were rejected (P. Response at 6). There is no dispute that Petitioner did direct these interventions, although CMS disagrees that hourly checks were regularly performed as planned. CMS Brief at 12; CMS Reply at 4-5. Petitioner also argues, contrary to CMS' position, that given Resident 1's history and diagnoses there was no way Petitioner could anticipate that Resident 1 could memorize the combination for the door keypad and/or operate that pad. P. Brief at 8; P. Response at 6-7.

The facility concedes that it was well aware of Resident 1's propensity to escape. P. Response at 6. The discharge summary from Dorothea Dix Hospital pertaining to Resident 1's discharge reflects a long history of mental illness, multiple psychiatric hospitalizations, and years of residence in nursing homes or psychiatric institutions. CMS Ex. 11, at 13-18. The facility also does not dispute that Resident 1 had demonstrated the ability to remove his "Wander Guard" anklet, but, due to safety considerations, Petitioner continued to use the same type anklet. Petitioner provided for my consideration a statement from James J. Pence, Jr., M.D. (P. Att. 4) and a declaration of Marsh Fretwell, M.D. (P. Att. 5). Dr. Pence is the medical director for Petitioner and he reviewed Resident 1's records. Dr. Pence opined that Resident 1 was a difficult patient; that Petitioner appropriately assessed Resident 1; that Petitioner implemented appropriate interventions; that Petitioner could not have anticipated Resident 1's "atypical and unexpected" behavior; and that Petitioner did all it could short of physical and chemical restraints to prevent Resident 1 from eloping. P. Att. 4. Dr. Fretwell, who is board certified in internal medicine with a certificate of added qualification in geriatric medicine, declares that she too reviewed Resident 1's records. Dr. Fretwell opines that Resident 1 was an "extraordinary high risk for elopement;" Resident 1 did not wander due to confusion but was goal directed and determined to succeed at escaping; a facility would not suspect that Resident 1 could memorize a numeric code for a security device if his diagnosis was correct; and there was little that could be done to prevent Resident 1's elopement "except place him in one-on-one observation 24 hours a day, 7 days a week." P. Att. 5.

While the law does not require a facility to provide one-on-one observation of every resident to ensure their safety, the law has been interpreted to require that a facility provide the supervision necessary to ensure that an individual resident is protected given that resident's situation. In this case, Petitioner knew upon his admission that Resident 1 was at high risk for elopement, in fact, he tried the day of admission. Petitioner also knew that Resident 1 could remove his Wander Guard anklet and should have realized that that form of monitoring was only minimally effective. Petitioner points to evidence that initially Resident 1 was checked each shift and then hourly. Petitioner's evidence shows that Resident 1's Wander Guard anklet was checked to ensure it was intact once per day. Petitioner has presented no evidence that indicates it was not possible to more aggressively monitor Resident 1 by checking his location every 30 minutes or every 15 minutes. Petitioner has presented no evidence showing why it was not possible to implement one-on-one observation before the elopement - Dr. Fretwell suggests one-on-one monitoring was appropriate and Petitioner did implement one-on-one after the elopement. Petitioner has presented no evidence as to why Resident 1's Wander Guard anklet was not checked to ensure that it was intact each time his location was checked, rather than just once per day. The argument that Petitioner could not anticipate that Resident 1 could memorize the key code for the security lock on its door does not constitute a defense. If Petitioner had simply been more aggressive in monitoring Resident 1, it is more likely that Petitioner would have been discovered before he exited the facility.

Accordingly, I conclude that Petitioner did not do all it could to supervise Resident 1 to prevent his elopement in violation of 42 C.F.R. � 483.25(h)(2). I cannot find that the surveyors' conclusion that this situation presented an isolated incident of immediate jeopardy for Resident 1 is clearly erroneous.

3. The alleged violation of 42 C.F.R. � 483.75(e)(8) (F Tag 497).

The regulation requires that a facility be "administered in a manner that enables it to use its resources effectively and efficiently to attain or maintain the highest practicable physical, mental, and psychosocial well-being of each resident." 42 C.F.R. � 483.75. A specific requirement is that a facility must provide a minimum of 12 hours of in-service training for each nurse aide based on areas of weakness identified during the aide's 12-month performance review and residents' special needs. 42 C.F.R. � 483.75(e)(8). The guidance to surveyors contained in Appendix P of the SOM, page PP 190, instructs the surveyors that the adequacy of a facility's in-service training program is not measured by documentation of hours alone, but also by the demonstrated competence of the nurse aide staff. The guidance also provides that the 12-month period is the 12 months from the anniversary date of the aide's employment.

In this case, the surveyor's do not make specific allegations about nurse aide competence but rather rely upon the facilities failure to document the required number of hours for three of its aides. The aides are identified as Aide 1 who began employment May 10, 2001; Aide 2 who began employment May 11, 1999; and Aide 3 who began employment March 29, 1995. The surveyors allege that on reviewing the in-service training records of Petitioner, they found that Aide 1 only had 20 minutes training during the period May 10, 2001 to May 10, 2002; Aide 2 only had 20 minutes training during the period May 11, 2001 to May 11, 2002; and Aide 3 only had 5 hours and 45 minutes training during the period May 10, 2001 to May 10, 2002. CMS Ex. 6, at 8-9. The pertinent period for Aide 3 should be the anniversary of her employment, March 29, 2001 to March 29, 2002. Because the surveyor's allege the wrong period regarding Aide 3 and I find no other evidence of record to aide my determination of whether or not there was a basis for the surveyor's allegations related to Aide 3, I conclude that CMS has not made a prima facie showing with regard to Aide 3. CMS has made a prima facie showing as to Aide 1 and 2.

Petitioner does not deny that the surveyors are correct in their allegations regarding the documentation they reviewed for Aides 1 and 2. Rather, Petitioner offers the explanation that the facility's Staff Development Coordinator had recently resigned and so not all in-service training had been recorded at the time of the survey. Petitioner asserts that records were updated subsequent to the survey and those documents have been admitted as P. Ex. 4. P. Brief at 9. In footnote 3 of its brief, counsel for Petitioner explains that entries bearing June 2002 dates are the result of recording information from the former Staff Development Coordinator's records. I am not sure what counsel intended by the footnote as it is not clear whether the June 2002 entries referred to are for training done during the pertinent period or not. A major difficulty with Petitioner's exhibit 4 is that it is unsupported by any declaration or affidavit explaining its content, the meaning of entries, or the source of the information contained therein. I decline to accept the arguments of counsel in briefs as testimony. Accordingly, I find that P. Ex. 2 does not rebut the prima facie showing by CMS or establish any defense.

Petitioner suggests that this deficiency does not present minimal harm to its residents. CMS argues to the contrary. Even if I agreed with Petitioner, it would have no impact upon the remedy that I will approve in this case.

4. The alleged violation of 42 C.F.R. � 483.75(o)(2) & (3) (F Tag 521).

This is another alleged violation of the regulation that requires that a facility be "administered in a manner that enables it to use its resources effectively and efficiently to attain or maintain the highest practicable physical, mental, and psychosocial well-being of each resident." 42 C.F.R. � 483.75. The specific requirement alleged is a violation of subsection 483.75(o)(2) which requires that a facility maintain a "quality assessment and assurance committee" that meets at least quarterly. The quality assessment and assurance committee is tasked with "identifying issues with respect to which quality assessment and assurance activities are necessary;" and to develop and implement "appropriate plans of action to correct identified quality deficiencies." Id. Subsection 483.75(o)(3) provides that the Secretary and the state may not require disclosure of the records of the committee except to show that the committee satisfies the requirements of the regulation.

The guidance to surveyors contained in SOM, App. P. at PP 201 - PP 202, establishes a two-phased assessment process. The survey team is to review how the quality assurance committee functions and determine whether the committee has a formal method to identify issues which require quality assurance and assessment activities. If the survey team identifies quality issues, then the team determines whether the committee has a protocol for addressing specific quality problems.

Surveyors should not focus on if the quality assurance committee has identified and addressed deficiencies which the survey team identifies. Concentrate on verifying that the facility has a quality assurance committee which addresses quality concerns and that staff know how to access that process.

Id. The surveyors allege in the SOD that the regulatory requirements for a quality assessment and assurance committee were not met because:

the facility did not have a working "quality assurance/improvement (QA/QI) committee to address quality issues of elopement or implement corrective actions (sic) plans as needed to rectify quality assurance issue of elopement and to evaluate the effectiveness of the submitted Plan of Correction for Federal Deficiency cited during the 11/01/0/ (sic) survey.

Id. The specific findings cited by the surveyors in support of this conclusion are:

(a) A Quality Improvement-Resident Wandering and Monitoring Tool indicates that mesh barriers and mesh stop signs will be used and that door alarms will be checked each shift;

(b) The surveyors saw no mesh barriers at residents' doorways or mesh stop signs at any exit door;

(c) Surveyors did not find documentation that exit alarms were checked each shift, but a "maintenance person" told them that exit alarms were checked on the days he worked and results were recorded;

(d) The Administrator told surveyors that the tool had been available for some time, but he had other more important issues and "this committee" had not met since he came to the facility; ⁽⁴⁾

(e) The DON told the surveyors that the tool had been available for some time but was not currently in use and that the first meeting of the "Quality Improvement Action Team" for wandering had not been scheduled but an orientation was scheduled.

(f) The plan of correction for the November 1, 2001 survey related to elopement indicates that issues identified would be reported to the Administrator for review and recommendations.

CMS has not made a prima facie showing of a violation by this deficiency citation. The Board defined the requirements for a prima facie case in its decision in Hillman, DAB 1611, p. 8:

HCFA must identify the legal criteria to which it seeks to hold a provider. Moreover, to the extent that a provider challenges HCFA's findings, HCFA must come forward with evidence of the basis for its determination, including the factual findings on which HCFA is relying and, if HCFA has determined that a condition of participation was not met, HCFA's evaluation that the deficiencies found meet the regulatory standard for a condition-level deficiency.

If a provider appeals an enforcement decision, CMS has the initial burden of showing that its decision to terminate is legally sufficient under the statute and regulations. To make a prima facie case that its decision was legally sufficient in this case, CMS must: (1) identify the statute, regulation or other legal criteria to which it seeks to hold the provider; (2) come forward with evidence upon which it relies for its factual conclusions that are disputed by the Petitioner; and (3) show how the deficiencies it found amount to noncompliance that warrants an enforcement remedy.

Regarding the alleged violation of 42 C.F.R. � 483.75(o)(2), the legal criteria are set forth by the regulation, i.e., the facility must have a "quality assessment and assurance committee" that meets at least quarterly; that identifies "issues with respect to which quality assessment and assurance activities are necessary" and develops and implements "appropriate plans of action to correct identified quality deficiencies." CMS states in its reply brief at page 9, citing surveyor notes at CMS Ex. 13, page 1, that facility staff told the surveyors that the facility had a working "Quality Assurance/Quality Improvement Committee" that specifically addresses quality issues. The surveyor notes, which are not easily deciphered, indicate "qA monthly & PRN" (which I construe to be quality assurance monthly and as needed) and "quarterly - qA" (which I construe to be quarterly quality assurance). Id. Petitioner asserts that it has a quality assurance committee that meets quarterly and that the "Quality Improvement Action Team" is not the same as the facility's quality assurance committee. P. Brief at 10; P. Response at 8-9. The single declaration of a surveyor submitted by CMS (CMS Ex. 16) does not explain this deficiency citation.

CMS encourages me to infer from the findings of the surveyors set forth above that Petitioner does not have a quality assessment and assurance committee and/or that it does not fulfill its regulatory duties. CMS Brief at 9-10. CMS Reply 14-15. CMS asserts that "Petitioner provides nothing more than its bare assertion" (CMS Brief at 9) and that "Petitioner has not provided any documentation show (sic) that it was in compliance" (CMS Reply at 15). CMS, however, overlooks that it must first establish its prima facie case before Petitioner is required to show anything. CMS cannot rely upon the mere conclusions of the surveyors stated in the SOD, but the findings of the surveyors must support their conclusions. I fail to see that the surveyors' allegations that interventions cited in response to a prior survey or interventions listed on a form not in use, standing alone, show that the facility had no functioning quality assessment and assurance committee or that it was not fulfilling its regulatory duties. It is clear that the surveyors did not use the recommended approach from the guidance to surveyors. It is equally clear that there was some confusion on the part of the surveyors as to which team or committee they were inquiring about. Finally, the fact that interventions proposed and/or implemented in response to a SOD from a survey six-months before are changed or altered, may as Petitioner suggests, actually be a sign that the quality assessment and assurance committee was actually working.

5. A per instance CMP of $7,500 is not reasonable, and it is, therefore reduced to $5,000.

In determining the amount of the CMP, the following factors specified at 42 C.F.R. � 488.438(f) must be considered: (1) the facility's history of non-compliance, including repeated deficiencies; (2) the facility's financial condition; (3) the seriousness of the deficiencies as set forth at 42 C.F.R. � 488.404; and (4) the facility's degree of culpability.

CMS determined to impose a per instance CMP of $7,500. CMS based its determination to impose this CMP largely upon the facility's past history of elopement, the elopement cited in this survey, and the potential for harm faced by Resident 1 during his elopement. CMS Brief at 16; CMS Reply at 10-11. Petitioner does not deny that it was previously cited for "elopement issues" but argues that in response it installed and implemented its Wander Guard system. Petitioner argues that its culpability is minimal considering that its staff did assess Resident 1 and did implement some interventions. Petitioner Brief at 12. Petitioner does not assert an inability to pay.

The regulation authorizes the imposition of per instance CMP ranging from $1,000 to $10,000. Pursuant to the guidance in Emerald Oaks, I must assess de novo the reasonableness of the CMP proposed by CMS based on the factors set forth at 42 C.F.R. � 488.438(f). The CMP of $7,500 proposed by CMS is in the upper range of the authorized remedy. CMS provided me with no evidence related to Petitioner's past history of noncompliance, but there seems to be no dispute that Petitioner was cited on a prior survey related to elopement. CMS seemed to consider the elopement related incident involving Resident 1 to be most significant in its determination of the CMP amount. I find that the facility's failure to properly document for staff the interventions to prevent Resident 1's elopement, as discussed under F Tag 309, and the actual elopement discussed under F Tag 324, weigh heavily in my consideration. I do not find that the violation of F Tag 497 supports a CMP. Of course, I found no violation of F Tag 521, thus it does not provide a basis for an enforcement remedy. Petitioner's ability to pay has not been placed in issue. I do not see evidence that the deficiency citations arose from indifference or gross negligence. Although not successful, Petitioner's staff made an effort to intervene and care for Resident 1. Contrary to Petitioner's assertions, however, Resident 1's elopement was an extremely serious incident which presented immediate jeopardy to the demented and delusional resident.

I have considered what would be a reasonable CMP for the instance of noncompliance involving Resident 1. I conclude that a $5,000 CMP is appropriate. I make my decision based on the factors cited at 42 C.F.R. �� 488.438(f) and 488.404 (incorporated by reference into 42 C.F.R. � 488.438(f)(3)). I have considered the following:

� Petitioner's history of non-compliance. There is no dispute that Petitioner had issues on a prior survey related to elopement.

� Petitioner's financial condition. Neither party offered any evidence to establish that Petitioner's financial condition was a bases for either sustaining or reducing the CMP.

� The seriousness of the deficiencies related to Resident 1 and Petitioner's culpability for those deficiencies.

IV. CONCLUSION

For the foregoing reasons, I conclude that Petitioner failed to comply substantially with federal participation requirements and a CMP of $5,000 is reasonable.

Keith W. Sickendick

Administrative Law Judge

1. CMS Ex. 19 is composed of the exhibits submitted by Petitioner on October 7, 2002, during the exchange process.

2. Petitioner's plan of correction as to all deficiencies was subsequently found acceptable by CMS.

3. I use the phrase "initial care plan" to describe or define the care plan in effect from admission until development and implementation of the comprehensive plan of care.

4. According to the SOD, the Administrator started February 4, 2002. CMS Ex. 6, at 9.