SUBJECT:

JFK Hartwyck at Edison Estates,

Petitioner,

Centers for Medicare & Medicaid Services.

DECISION

Petitioner, JFK Hartwyck at Edison Estates, was not in substantial compliance with 42 C.F.R. � 483.25(h)(2) on September 23, 2001, resulting in immediate jeopardy to facility residents. A per instance civil money penalty (CMP) of $10,000 is reasonable. By operation of law, Petitioner was prohibited from conducting its own nurse aide training and competency evaluation program for two years from the date of the survey which was completed on September 26, 2001.

I. PROCEDURAL HISTORY

Petitioner is a long-term care facility located in Edison, New Jersey, and authorized to participate in the federal Medicare program as a skilled nursing facility (SNF) through a participation agreement with the Secretary for Health and Human Services (the Secretary). The New Jersey Department of Health and Senior Services (the state agency) completed a complaint survey of Petitioner's facility on September 26, 2001. State agency surveyors allege, based on the survey, that Petitioner was not in substantial compliance with federal participation requirements and that the noncompliance constituted immediate jeopardy to resident health or safety.

CMS, by letter dated October 15, 2001, notified Petitioner that, based upon the September 26, 2001 complaint survey, it was imposing a per instance CMP in the amount of $10,000 for the deficiency that posed immediate jeopardy and a denial of payment for new admissions effective October 3, 2001 through October 8, 2001. The letter further advised Petitioner that it was prohibited from conducting its own nurse aide training and competency evaluation program for two years. CMS also advised Petitioner that the revisit survey on October 9, 2001, determined that Petitioner's immediate jeopardy situation was corrected and the facility had attained substantial compliance with all participation requirements.

Petitioner requested a hearing by an administrative law judge (ALJ) by letter dated December 13, 2001. The case was assigned to me for hearing and decision on February 26, 2002. On August 12, 2002, I granted the parties' request to waive oral hearing and to submit the case on briefs and documentary evidence. On August 23, 2002, Petitioner moved for summary judgment, seeking to bind CMS to the results of informal dispute resolution. I denied Petitioner's motion for summary judgment in a ruling dated April 9, 2003, and directed that the parties complete briefing and submission of documentary evidence on the merits of the one deficiency in issue.

Petitioner submitted 16 exhibits, Petitioner exhibits (P. Exs.) 1 through 16, with its opening brief. CMS, in its opening brief, noted that its exhibit citations were to the proposed exhibits previously submitted by CMS as part of its prehearing exchange on May 31, 2002. In that earlier submission, CMS submitted 34 proposed exhibits, CMS exhibits (CMS Exs.) 1 through 34. No objections were made as to any of the proffered exhibits, and P. Exs. 1 through 16 and CMS Exs. 1 through 34 are admitted and considered 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, a long-term care facility located in Edison, New Jersey, was authorized to participate in the federal Medicare program as a SNF through a participation agreement with the Secretary.

2. The state agency conducted a complaint and partial extended survey of Petitioner's facility on September 26, 2001, due to Petitioner's self-report of an incident involving Resident 1.

3. Petitioner requested by letter dated December 13, 2001, that an ALJ review the decision of CMS to impose a $10,000 CMP based upon an alleged violation of 42 C.F.R. � 483.25(h)(2) found during the September 26, 2001 survey, that allegedly posed immediate jeopardy to Resident 1.

4. Findings related to the violation of 42 C.F.R. � 483.25(h)(2):

a. Between about 2:15 p.m. and 2:30 p.m. on September 23, 2001, Eugene Tava, the recreational therapist, took Resident 1 to the second floor dining room, which is also used as an activity room, to watch a movie. CMS Ex. 3, at 6, 11; CMS Ex. 9, at 4, 7; P. Exs. 3-4.

b. Eugene Tava, during the time he took Resident 1 to the dining room, was also taking residents to the third floor for church services and was responsible for supervising residents in both the second and third-floor dining/activity rooms. CMS Ex. 8, at 16; CMS Ex. 9, at 7; P. Ex. 4.

c. Mr. Tava left the second floor dining room at 2:45 p.m. to observe church services on the third floor where he remained until about 3:15 p.m. before returning to the second floor. CMS Ex. 8, at 16; CMS Ex. 9, at 7; P. Ex. 4.

d. Mr. Tava did not see Resident 1 on his return to the second floor dining room, and he did not return Resident 1 to her room. CMS Ex. 8, at 16; CMS Ex. 9, at 7, 9.

e. At about 3:00 p.m. on September 23, 2001, the certified nurse aide responsible for Resident 1 began her shift and found that Resident 1 was not in her room and a search was ultimately begun about 4:15 p.m. CMS Ex. 6, at 15; CMS Ex. 8, at 1; CMS Ex. 9, at 1, 11; P. Exs. 6-8.

f. A security guard found Resident 1 at 8:30 p.m. on September 23, 2001, in the fire stairwell off the second floor activity room; Resident 1 was part-way down the stairwell; propped up on the stairs with her back against the wall, with the wheelchair above her; bleeding from her head, semi-conscious, with pale color and faint pulse. CMS Ex. 6, at 15; CMS Ex. 9, at 13, 16-17; CMS Ex. 12, at 1.

g. The 911 Mobile Intensive Care Unit/Patient Care Report reflects that, upon arrival at 8:33 p.m., Resident 1 was unresponsive, blood was on her clothing and on several steps, and her respirations were agonal. CMS Ex. 17, at 1-2.

h. Resident 1 was transported to the hospital emergency room at 8:42 p.m. on September 23, 2001, went into cardiac arrest and was pronounced dead at 9:15 p.m. at the hospital. CMS Ex. 17, at 1-3; CMS Ex. 18, at 4.

i. Resident 1 and an unknown number of other residents were left unsupervised in the second floor dining room for at least 30 minutes between 2:45 p.m. and 3:15 p.m. on September 23, 2001.

5. Findings related to the remedy:

a. Petitioner has a past history of noncompliance involving the failure to provide adequate supervision in violation of 42 C.F.R. � 483.25(h)(2) with immediate jeopardy.

b. In this case, the deficiency citation is based upon an extremely serious incident and there is no dispute Resident 1 suffered actual harm. Petitioner's Brief (P. Br.) at 16; Petitioner's hearing request, at 2.

c. Petitioner was culpable for Resident 1's accident.

d. Petitioner has not asserted an inability to pay a CMP of $10,000.

B. CONCLUSIONS OF LAW

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

2. The parties waived oral hearing.

3. Petitioner violated 42 C.F.R. � 483.25(h)(2) (Tag F324) by failing to provide adequate supervision to Resident 1 and other residents on September 23, 2001.

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

5. A per instance CMP of $10,000 is reasonable given the factors specified at 42 C.F.R. � 488.438(f).

6. Petitioner was properly subject to the prohibition on conducting a nurse aide training and competency evaluation program for two years based upon the imposition of a CMP of not less than $5,000 and the partial extended survey conducted by CMS upon finding substandard quality of care.

III. ANALYSIS

A. ISSUES

The general issues are:

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

2. Whether the remedy imposed is reasonable.

In my Ruling Denying Petitioner's Motion for Summary Judgment dated April 9, 2003, I requested that the Parties address the following specific issues:

1. Whether Petitioner was in substantial compliance with program participation requirements on September 26, 2001.

2. If Petitioner was not in substantial compliance on September 26, 2001, did conditions in the facility pose immediate jeopardy to resident health and safety?

3. If the facility was not in substantial compliance, is the amount of the CMP imposed, $10,000, reasonable?

4. If the facility was not in substantial compliance, was CMS authorized to prohibit Petitioner from conducting a nurse aide training and competency evaluation program?

B. APPLICABLE LAW

Petitioner is a long-term care facility participating in the federal Medicare program as a SNF pursuant to a participation agreement with the Secretary. The statutory and regulatory requirements for participation by a long-term care facility are found at sections 1819 and 1919 of the Act and at 42 C.F.R. Part 483. Sections 1819 and 1919 of the Act vest the Secretary with authority to impose a CMP 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, 488.300-488.335. Pursuant to 42 C.F.R. Part 488, 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 in 42 C.F.R. Part 488 also give CMS a number of other remedies that can be imposed if a facility is not in compliance with Medicare requirements. Id.

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. 42 C.F.R. �� 488.408, 488.438. 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. 42 C.F.R. �� 488.438(a)(1)(i), (d)(2). 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. 42 C.F.R. � 488.438(a)(1)(ii). There is only a single range of $1,000 to $10,000 for a per instance CMP, which applies whether or not immediate jeopardy is present. 42 C.F.R. �� 488.408(d)(1)(iv); 488.438(a)(2). In the case before me the CMP imposed was a "per instance" CMP of $10,000.

Under the regulations, "immediate jeopardy" is defined as "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." 42 C.F.R. � 488.301. Further, the regulations define the term "substantial compliance" to mean "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.

The Act and regulations make a hearing before an ALJ available to a long-term facility against whom CMS has determined to impose a CMP. Act, section 1128A(c)(2); 42 C.F.R. �� 488.408(g); 498.3(b)(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. Thompson, 363 F.3d 583 (6^th Cir.2003). The Departmental Appeals Board (the Board or DAB) has long held that the net effect of the 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). Review of a CMP by an ALJ is governed by 42 C.F.R. � 488.438(e).

In this case, there is also an issue related to whether or not Petitioner could conduct a nurse aide training and competency evaluation program. Pursuant to sections 1819(b)(5) and 1919(b)(5) of the Act, skilled nursing facilities and nursing facilities may only use nurse aides who have completed a training and competency evaluation program. Sections 1819(e) and 1919(e) of the Act impose upon the states the requirements to specify what nurse aide training and competency evaluation programs they will approve that meet the requirements established by the Secretary and a process for reviewing and reapproving those programs using criteria set by the Secretary. Pursuant to sections 1819(f)(2) and 1919(f)(2) of the Act, the Secretary was tasked to develop requirements for approval of nurse aide training and competency evaluation programs and the process for review of those programs. The Secretary promulgated regulations at 42 C.F.R. Part 483, subpart D.

Pursuant to 42 C.F.R. � 483.151(b)(2) and (e)(1), a state may not approve and must withdraw any prior approval of a nurse aide training and competency evaluation program offered by a skilled nursing or nursing facility that: (1) has been subject to an extended or partial extended survey under sections 1819(g)(2)(B)(i) or 1919(g)(2)(B)(i) of the Act; (2) has been assessed a CMP of not less than $5,000; or (3) has been subject to termination of its participation agreement, denial of payment, or the appointment of temporary management. "Substandard quality of care" is identified by the situation where surveyors identify one or more deficiencies related to participation requirements established by 42 C.F.R. � 483.13 (Resident Behavior and Facility Practices), 42 C.F.R. � 483.15 (Quality of Life), or 42 C.F.R. � 483.25 (Quality of Care) that are found to constitute either immediate jeopardy, a pattern of or widespread actual harm that does not amount to immediate jeopardy, or a widespread potential for more than minimal harm that does not amount to immediate jeopardy and there is no actual harm. 42 C.F.R. � 488.301. Extended and partial extended surveys are triggered by a finding of "substandard quality of care" during a standard or abbreviated standard survey and involve evaluating additional participation requirements. Id. As already noted, a facility is not normally entitled to ALJ review of a CMS or state agency level of noncompliance determination (also known as the "scope and severity" determination). The only two exceptions are where the amount of the CMP might be affected and where there was a finding of "substandard quality of care" that led to loss of approval of a facility's nurse aide training and competency evaluation program. 42 C.F.R. � 498.3(b)(14).

C. DISCUSSION

This case arises from Petitioner's reporting the death of Resident 1 and the state agency's subsequent complaint survey of Petitioner's facility on September 26, 2001. The results of the survey were recorded in a Statement of Deficiencies, form HCFA-2567L (SOD), with a survey completion date of September 26, 2001. CMS Ex. 19; P. Ex. 5. Petitioner was cited with violations of 42 C.F.R. �� 483.25(h)(2) (Tag F 324) and 483.75(d)(1)-(2) (Tag F 493). The violation of 42 C.F.R. � 483.25(h)(2) (Tag F 324) was alleged to present immediate jeopardy and constitute substandard quality of care. Id. Based on a revisit survey conducted by the state survey agency on October 9, 2001, it was determined that Petitioner was in substantial compliance with regulatory requirements as of that date. CMS Ex. 30. Petitioner's December 13, 2001 request for hearing only requests review of the alleged violation of 42 C.F.R. � 483.25(h)(2) which was alleged to pose immediate jeopardy. ⁽¹⁾

1. Petitioner violated 42 C.F.R. � 483.25(h)(2) (Tag F 324) on September 23, 2001.

A facility must 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 42 C.F.R. � 483.25(h)(2), the regulatory end is the prevention of accidental injury of nursing facility residents. The issue, generally, is whether the quality of the supervision or the use, or lack thereof, of assistive devices at a long-term care facility was such that residents were subject to the risk of injury from accidental causes in their daily activities. 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 regulation clearly requires that a facility provide both "assistive devices" and "adequate supervision" to prevent accidents. 42 C.F.R. � 483.25(h)(2). Whether a facility's supervision or assistive devices can be considered adequate depends on what kind of measures would be calculated to prevent potential accidents from occurring given the known or reasonably foreseeable risks. The Board has indicated that in order to evaluate a facility's compliance with 42 C.F.R. � 483.25(h)(2), 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). 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. Woodstock Care Center, DAB No. 1726, at 26-27 (2000), aff'd, Woodstock Care Center v. Thompson, 363 F.3d 583 (6^th Cir. 2003).

CMS alleges, in this case, that Petitioner violated the quality of care requirement to prevent accidents because Petitioner's "staff failed to assure the safety of resident #1 on 9/23/01." CMS Ex. 19, at 1; P. Ex. 5, at 1.

There is little or no dispute about the key facts in this case. The parties stipulated as follows in their Joint Stipulation of Undisputed Facts dated July 1, 2002 (Jt. Stip.):

� Following a search by Edison Estate's staff, a missing 99-year old wheelchair-bound resident was found at approximately 8:30 p.m. on September 23, 2001 by facility staff on a stairwell off the activity room on the second floor of Edison Estates' facility.

� The resident was determined to have serious injuries and was transported to the JFK Medical Center in Edison, N.J., where she expired at approximately 9:15 p.m.

� The incident was reported to the New Jersey Department of Health and Senior Services by Edison Estates on September 24, 2001.

P. Ex. 1 (Jt. Stip., �� 3-5).

The evidence shows that Resident 1 was 99 years old, had a diagnosis of dementia, was totally dependent on staff for transfers, used a wheelchair and was non-ambulatory in her wheelchair, i.e., she could not push herself, and she had a history of depression. CMS Ex. 6 at 2, 12, 17, 18; P. Ex. 15, at 6. Between about 2:15 p.m. and 2:30 p.m. on September 23, 2001, Eugene Tava, the recreation therapist, took Resident 1 to the second floor dining room, which is also used as an activity room, to watch a movie. CMS Ex. 3, at 6, 11; CMS Ex. 9, at 4, 7; P. Exs. 3-4. Eugene Tava indicated in a telephone interview that during the time he took Resident 1 to the dining room, he was also taking residents to the third floor for church services. CMS Ex. 9, at 7; P. Ex. 4; see CMS Ex. 8, at 16. A marginal note on Mr. Tava's interview notes indicates that he was "doing both floors at the same time." CMS Ex. 9, at 7. Mr. Tava left the second floor dining room at 2:45 p.m. to observe church services on the third floor. Mr. Tava said that he saw Bob Jones ⁽²⁾ in the dining room when he left about 2:45 p.m. He observed the church service on the third floor from approximately 2:45 p.m. to 3:15 p.m. and then returned to the second floor dining room at about 3:15 p.m. He changed the television to a station that was showing a ceremony at Yankee Stadium. CMS Ex. 8, at 16; CMS Ex. 9, at 7; P. Ex. 4. There is no indication that Mr. Tava saw Resident 1 on his return to the second floor dining room, but it is clear that he did not return Resident 1 to her room. CMS Ex. 8, at 16; CMS Ex. 9, at 7, 9.

At about 3:00 p.m., the certified nurse aide (CNA) who was responsible for Resident 1 began her shift and found that Resident 1 was not in her room. Resident 1's roommate told the CNA that the resident had gone to the activity/dining room. CMS Ex. 9, at 1, 11; P. Ex. 6. The CNA stated that, at 3:40 p.m., she went to the activity/dining room to bring the resident back for dinner, but did not find her and started to search for her. The CNA notified the nursing supervisor that Resident 1 was missing at about 4:15 p.m. on September 23, 2001. CMS Ex. 6, at 15; CMS Ex. 8, at 1; CMS Ex. 9, at 1, 11; P. Exs. 6-8.

A security guard found Resident 1 at 8:30 p.m. on September 23, in the fire stairwell off the second floor activity room. The resident had fallen part-way down the stairwell and was found propped up on the stairs with her back against the wall, with the wheelchair above her. She was bleeding from her head. The resident was semi-conscious, her color was pale, and her pulse was faint. She was given oxygen, an IV was started, and 911 was called. CMS Ex. 6, at 15; CMS Ex. 9, at 13, 16-17; CMS Ex. 12, at 1. The 911 Mobile Intensive Care Unit/Patient Care Report reflects that, upon arrival at 8:33 p.m., Resident 1 was unresponsive, blood was on her clothing and on several steps, and her respirations were agonal. CMS Ex. 17, at 1-2. The resident was transported to the hospital emergency room at 8:42 p.m. She went into cardiac arrest en route and CPR was initiated. The resident was intubated and despite aggressive resuscitation efforts, she was pronounced dead at 9:15 p.m. at the hospital. CMS Ex. 17, at 1-3; CMS Ex. 18, at 4.

CMS has made a prima facie showing of a violation of 42 C.F.R. � 483.25(h)(2) by showing that Resident 1 was injured as the result of an accident, ⁽³⁾ i.e., CMS has produced sufficient evidence that, absent conflicting evidence, shows a violation occurred. Meadow Wood Nursing Home, DAB No. 1841, at 7 (2002); Emerald Oaks, DAB No. 1800, at 16 (2001). Thus, the burden is upon Petitioner to rebut the prima facie case by showing that it was, more likely than not, in substantial compliance or to establish an affirmative defense. Emerald Oaks, at 16.

Petitioner counters CMS's allegations by arguing that it should not be held to a strict liability standard and faulted for any injury to a resident that results from an accident on its premises. The Board has made clear in several cases that 42 C.F.R. � 483.25(h)(2) does not make a facility strictly liable for accidents that occur to a resident. See Koester Pavilion, DAB No. 1750 (2000). If a facility was strictly liable for every injury or accident that occurs to a resident, Petitioner would have no defense and would be liable without question upon a prima facie showing by CMS. However, because strict liability is not the standard by which to judge Petitioner's conduct, Petitioner can present defenses to CMS's allegations that might be recognized under state or federal common law, e.g., that it had implemented reasonable interventions, that the accident was unforeseeable, or that there was an intervening cause.

Petitioner contends that the SOD contains no allegation that Resident 1's careplanning was deficient or that the resident was improperly assessed. Petitioner also posits the theory that the incident involving Resident 1 may have been the result of an intentional, probably criminal, act.

I do not find Petitioner's arguments persuasive. Petitioner asserts that its careplanning for Resident 1 was appropriate, and that it identified "all relevant risks for accidental injury" to Resident 1. ⁽⁴⁾ P. Br. at 11. Petitioner points out that its staff identified Resident 1 to be at risk for tipping in her wheelchair and implemented a wheelchair anti-tipping device as an intervention. P. Ex. 15, at 2; CMS Ex. 6, at 11. Petitioner contends further that its staff did not consider Resident 1 to be at risk for attempting to exit the facility or inappropriately using emergency fire exit doors, given her physical status. P. Br. at 11. Therefore, according to Petitioner, her accident was an unforeseeable and unpreventable event.

Petitioner's suggestion that it should be absolved of responsibility due to the fact that Resident 1's particular accident had not been identified as being in her universe of potential accidents is without merit. Resident 1 was 99 years old at the time of her accident, demented, and non-ambulatory. There is no evidence that Petitioner was capable of protecting or defending herself. Her care plan assessed her as having the potential for falls, and noted that the use of safety precautions and monitoring were required. CMS Ex. 7, at 2; CMS Ex. 6, at 18. While the Board in Woodstock recognized that a facility is not required to do the impossible or be a guarantor against unforeseeable occurrences, leaving Resident 1 unattended for a period of time presented an obvious risk of injury that Petitioner's staff should have foreseen. Moreover, in Coquina Center, DAB No. 1860 (2002), the Board concurred with the ALJ's opinion that, with a foreseeable risk that a facility could have practicably prevented, CMS did not have to show "that Petitioner foresaw the precise way in which harm would be visited upon residents as a result of its facility's failure to comply with participation requirements" in order to support a deficiency finding. Coquina Center, DAB No. 1860 (2002), at 20, quoting Coquina Center, DAB CR899 (2002), at 10.

The important point that Petitioner never directly addresses in this case is why Resident 1 and an unknown number of other residents were left unsupervised in the second floor dining room for at least 30 minutes between 2:45 p.m. and 3:15 p.m. on September 23, 2001. The evidence shows that one staff member, Eugene Tava, was attempting to supervise activities on both the second and third floors during the same period of time. The evidence does not reveal how many residents were being supervised in the two locations or the nature of those residents impairments or functional abilities, but it is not necessary to resolve these questions. The key is that Resident 1 was left without staff supervision with a group of other residents for at least 30 minutes in a common area. Petitioner cannot argue in good faith that supervision for Resident 1 or any of the other residents was adequate, as there was no supervision at all. Petitioner had the duty under 42 C.F.R. � 483.25(h)(2) to take all reasonable steps to provide adequate supervision to prevent accidental injury to Resident 1 and other residents. In this case, there is no question that Resident 1 was unsupervised with an unknown number of other residents for an extended period of time. Petitioner presents no defense to that.

As for Petitioner's contention that Resident 1 may have been the victim of an intervening criminal act, I am unpersuaded. Petitioner has offered no evidence from which I might infer, given Resident 1's inability to move herself, that someone must have moved her. Petitioner concedes that the incident was investigated by Petitioner and the county prosecutor's office, but that no determination could be made as to how Resident 1 accessed the stairwell area or fell down the stairs. P. Br. at 5. Even if I were to accept that someone pushed Resident 1 down the stairwell, either intentionally, negligently or accidentally, that does not excuse Petitioner's failure to supervise Resident 1 and its other residents.

Petitioner contends that, following Resident 1's accident, it made immediate changes to protect its residents and minimize the risk of such an incident happening again. This was apparently confirmed by the revisit survey that found Petitioner again in compliance. However, the fact that Petitioner implemented remedial measures after Resident 1's accident is no defense to its violation of 42 C.F.R. � 483.25(h)(2) on September 23, 2001.

Based on the foregoing evidence, I find that Petitioner has not shown by a preponderance of the evidence that it took all reasonable measures to supervise Resident 1 so as to safeguard her from an accident, in violation of 42 C.F.R. � 483.25(h)(2). Petitioner has not overcome CMS's prima facie showing that Resident 1 was unsupervised and an accident happened.

Further, I do not find that CMS's determination of an immediate jeopardy level deficiency was clearly erroneous. Under the regulations, "immediate jeopardy" is defined as "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." 42 C.F.R. � 488.301. Resident 1 was seriously injured as a result of the failure by Petitioner's staff to supervise her and other residents in the dining room on the second floor on September 23, 2001. This situation fits squarely within the definition of immediate jeopardy.

2. A per instance CMP of $10,000 is reasonable.

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. In deciding what penalty amount is reasonable, I must examine the evidence that relates to the regulatory factors. My role is not to review for correctness CMS's determination as to penalty amount. I must decide de novo whether the evidence justifies a particular amount.

In this case, CMS determined to impose a per instance CMP of $10,000. CMS based its determination to impose this CMP on Petitioner's past history of noncompliance under Tag F 324, the seriousness of the deficiency, and Petitioner's culpability in failing to adequately supervise and protect Resident 1. CMS asserts also that Petitioner has presented no evidence that it is financially unable to pay a CMP of $10,000.

Petitioner argues that a $10,000 CMP is unreasonable and the CMP should instead fall within the lower range of $50 to $3,000. Petitioner argues also that if it is found to have been out of compliance with program requirements at the immediate jeopardy level, the CMP imposed should only be $3,050, the lowest amount in the immediate jeopardy range. P. Br. at 19-20. Petitioner disputes CMS's claim that it has a history of noncompliance and contends, moreover, that Resident 1's accident was a "one-time occurrence that did not cause any harm to any other residents." Id. at 19. Furthermore, it denies any culpability based on its theory that the incident was a criminal act that staff most likely could not have prevented. Lastly, Petitioner argues that CMS has not met its burden of proving Petitioner's ability to pay the CMP. Id.

Contrary to Petitioner's assertion, the evidence presented by CMS shows that Petitioner was previously cited for a deficiency under Tag F 324 at the immediate jeopardy level in March 2000. At the March 2000 survey, Petitioner was found in violation of the requirements of 42 C.F.R. � 483.25(h)(2) in connection with its failure to properly supervise a resident with Alzheimer's disease who eloped and was found in a ditch. This determination was sustained by ALJ Kessel in JFK Hartwyck at Edison Estates, DAB CR840 (2001). Declaration of Kathleen Gormaley. Petitioner's contention that "the instance of resident elopement addressed in Ms. Gormaley's Declaration occurred 18 months prior to the incident involving Resident 1" (Petitioner's Response Brief at 9 (emphasis included)) makes little sense, since an examination of Petitioner's history of noncompliance would, by definition, include any past incidents where Petitioner had not complied with participation requirements. The regulations do not place any temporal restrictions when looking back at a facility's history of noncompliance. It is evident that Petitioner has a past history of noncompliance involving the failure to provide adequate supervision. Moreover, its past deficiency was found to constitute immediate jeopardy, the same level of noncompliance cited in the instant case.

Whether or not a deficiency resulted in actual harm is a factor to consider in determining the reasonableness of a remedy. 42 C.F.R. �� 488.404(b)(1)(iii) and (iv). In this case, the deficiency citation is based upon an extremely serious incident and there is no dispute Resident 1 suffered actual harm. P. Br. at 16; Petitioner's hearing request, at 2.

Despite Petitioner's denial of culpability, the evidence plainly indicates that Petitioner was completely culpable for Resident 1's accident. As I have discussed above, Petitioner cannot escape culpability by claiming the accident was unforeseeable or attempting to hide behind its unsupported theory that Resident 1 was subjected to a criminal act. The term "culpability" is defined at 42 C.F.R. � 488.438(f)(4) to include, but to not be limited to, neglect, indifference, or disregard for a resident's care, comfort, or safety. Petitioner's staff failed to discharge their respective duties to protect Resident 1 and the other residents. The staff exhibited neglect, indifference, and disregard for Resident 1's care and safety in failing to supervise and monitor her so that she did not sustain an accident.

With respect to Petitioner's financial condition, Petitioner is incorrect in asserting that CMS has the burden to prove its ability to pay. On the contrary, if Petitioner wished to contend that its financial condition would not support the CMP amount, it had the burden to make such a contention in a timely fashion. Once it made such a contention, CMS would then have had the responsibility to produce evidence as to that factor. Coquina Center, DAB No. 1860 (2002); Community Nursing Home, DAB No. 1807 (2002). Here, Petitioner has not asserted an inability to pay. Petitioner has not provided any evidence that its financial condition would preclude it from paying a $10,000 CMP.

Based on my consideration of the regulatory factors listed in 42 C.F.R. � 488.438(f), I find that the per instance CMP of $10,000 imposed by CMS is reasonable. Petitioner's staff's failure to supervise a 99-year-old, wheelchair-bound resident resulted in a tragic accident and the death of that resident. This was a serious deficiency that presented immediate jeopardy to Resident 1's health and safety. Although the $10,000 amount is at the top of the range for a per instance CMP under the regulations, I find it to be authorized and appropriate as a mechanism to ensure future compliance and to protect Medicare beneficiaries.

3. Petitioner was properly subject to the prohibition on conducting a nurse aide training and competency evaluation program for two years.

In addition to the CMP, I conclude that the state agency was required to prohibit Petitioner from conducting a nurse aide training and competency evaluation program for two years. Pursuant to section 1819(f)(2)(B)(iii)(I)(b) and (c) of the Act and 42 C.F.R. � 483.151(b)(2) and (e)(1), a state may not approve and must withdraw any prior approval of a nurse aide training and competency evaluation program offered by a skilled nursing or nursing facility that: (1) has been subject to an extended or partial extended survey under sections 1819(g)(2)(B)(i) or 1919(g)(2)(B)(i) of the Act; (2) has been assessed a CMP of not less than $5,000; or (3) that has been subject to termination of its participation agreement, denial of payment, or the appointment of temporary management. CMS conducted a partial extended survey (CMS Ex. 2, at 3; CMS Ex. 14) and imposed a CMP of $10,000, both of which trigger the two-year prohibition in this case.

IV. CONCLUSION

For the foregoing reasons, I conclude that Petitioner violated 42 C.F.R. � 483.25(h)(2), and that violation posed immediate jeopardy for its residents. A CMP of $10,000 is reasonable given the facts. Petitioner was properly subject to a two-year ban on conducting a nurse aide training and competency evaluation program which, according to CMS, was effective from September 26, 2001 to September 26, 2003. CMS R. Br. at 15.

Keith W. Sickendick

Administrative Law Judge

1. The other deficiency, cited as a violation of 42 C.F.R. � 483.75(d)(1)-(2) (Tag F 493), alleges that while the surveyors were in the facility on September 26, 2001, they observed two ambulatory residents transporting (pushing) wheelchair bound residents and Petitioner's Administrator had no system to assess the competence of these ambulatory residents to safely push the wheelchairs of the wheelchair bound residents. The deficiency was cited at a scope and severity level of D. Scope and severity levels are used by CMS and a state when selecting remedies. The scope and severity level is designated by an alpha character, A through L, selected by CMS or the state agency from the scope and severity matrix published in the State Operations Manual (SOM), section 7400E. A scope and severity level of A, B, or C indicates a deficiency that presents no actual harm but has the potential for minimal harm. Facilities with deficiencies of a level no greater than C remain in substantial compliance. 42 C.F.R. � 488.301. A scope and severity level of D, E, or F indicates a deficiency that presents no actual harm but has the potential for more than minimal harm that does not amount to immediate jeopardy. A scope and severity level of G, H, or I indicates a deficiency that involves actual harm that does not amount to immediate jeopardy. Scope and severity levels J, K, and L are deficiencies that constitute immediate jeopardy to resident health or safety. Letters A, D, G, and J indicate an isolated occurrence, letters B, E, H, and K indicate a pattern of occurrences, and letters C, F, I, and L indicate widespread occurrences. The matrix, which is based on 42 C.F.R. � 488.408, specifies which remedies are required and optional at each level based upon the frequency of the deficiency. See SOM, section 7400E.

2. It is not clear whether Bob Jones was a facility employee or not, but his statement indicates that his wife was a resident. On September 23, 2001, he arrived to see her at about 12:15 p.m. Sometime between roughly 1:00 p.m. and 2:45 p.m., Mr. Jones played the piano in the third-floor dining room for awhile. When the church group members and residents had arrived and were ready to start the service, he then went to the second-floor dining room where he saw some residents, including his wife, watching television. He stated that Eugene was in the room eating his lunch. Mr. Jones then went outside to do some gardening. CMS Ex. 10, at 1. Mr. Jones' name does not appear on the list of staff on duty on September 23, 2001. CMS Ex. 3, at 6.

3. An "accident" is "an unexpected, unintended event that can cause a resident bodily injury," excluding "adverse outcomes associated as a direct consequence of treatment or care (e.g., drug side effects or reactions)." SOM, App. P, page PP-105, Guidance to Surveyors for Long Term Care Facilities, Part 2, F324, Quality of Care (Rev. 274, June 1995); Woodstock Care Center, DAB No. 1726, at 4 (2000).

4. CMS acknowledges that Resident 1's care plan was not found deficient. CMS Response Brief (CMS R. Br.) at 4.