SUBJECT:

Cal Turner Extended Care Pavilion,

Petitioner,

Centers for Medicare & Medicaid Services.

DECISION

Petitioner, Cal Turner Extended Care Pavilion, was not in compliance with federal Medicare and Medicaid participation requirements during the period from February 20, 2002 to June 5, 2002. A total civil money penalty (CMP) of $30,750 is reasonable ($250 per day for the 84-day period from February 20, 2002 through May 15, 2002, which amounts to $21,000; $5,000 for one day of immediate jeopardy on May 16, 2002; and $250 per day for the 19 days, May 17, 2002 through June 4, 2002, amounting to $4,750). Pursuant to 42 C.F.R. � 488.417(b)(1) ⁽¹⁾ and (c), the Centers for Medicare & Medicaid Services (CMS) was required to deny payment for new admissions (DPNA) to Petitioner for the period May 20, 2002 (the last day of the survey identifying the noncompliance) to June 5, 2002 (the date Petitioner achieved substantial compliance). Pursuant to 42 C.F.R. �� 483.151(b)(2) and (e)(1), the state agency could not approve and was required to withdraw any previously granted approval for Petitioner to conduct a nurse aide training and competency evaluation program (NATCEP) during the two-year period from May 16, 2002 (the effective date of the $5,000 CMP (42 C.F.R. � 483.151(b)(3)) through May 15, 2004.

I. PROCEDURAL HISTORY

Petitioner was surveyed by Kentucky Division of Long Term Care (the state agency) surveyors on February 18 through 20, 2002, May 15 and 16, 2002, May 29, 2002, and June 25, 2002. Joint Stipulation of Undisputed Facts (Jt. Stip.). CMS notified Petitioner by letter dated May 22, 2002 that based upon the survey completed on February 20, 2002 and the revisit-survey completed on May 16, 2002, CMS proposed to impose remedies including a CMP ($250 per day effective February 20 through May 14, 2002, and $4,050 per day effective May 16, 2002, until immediate jeopardy was removed), a DPNA effective May 20, 2002, and termination of the facility's provider agreement effective June 8, 2002. CMS Exhibit (CMS Ex.) 3. CMS notified Petitioner by letter dated June 5, 2002 that a revisit-survey completed on May 29, 2002 concluded that immediate jeopardy found during the survey completed May 16, 2002 had been abated, but the facility continued to be out of compliance with participation requirements. CMS further advised that remedies imposed remained in effect and that the proposed CMP was reduced effective May 17, 2002 to $250 per day. CMS Ex. 5. CMS notified Petitioner by letter dated July 2, 2002 that the June 25, 2002 survey found Petitioner achieved substantial compliance effective June 5, 2002. Thus, the DPNA was effective May 25, 2002 through June 4, 2002, and the termination action was cancelled. CMS Ex. 6. Petitioner requested a hearing by an administrative law judge (ALJ) by letter dated July 29, 2002. CMS Ex. 7. The case was assigned to me for hearing and decision on August 21, 2002.

On September 10, 2002, CMS moved for partial summary judgment and/or dismissal of Petitioner's request for hearing. The parties briefed CMS's motion, and I denied CMS's motion in my order dated December 19, 2002, concluding that Petitioner's request for hearing was timely filed. I held a hearing at Bowling Green, Kentucky on July 31, 2003. At the hearing, I admitted as evidence CMS's exhibits 1, 2, 2A, 3, 4, 4A and 5 through 25, and Petitioner's exhibits (P. Exs.) 1 and 2. Hearing Transcript (Tr.) at 19-22. At the conclusion of the hearing, I established a schedule for the parties to file post-hearing briefs and response briefs. Briefing is complete.

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 set forth here.

1. Petitioner, located in Scottsville, Kentucky, 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). Jt. Stip.

2. Petitioner requested a hearing by letter dated July 29, 2002, to challenge the remedies proposed by CMS based upon the findings of the surveys completed by the state agency on February 20, 2002, May 16, 2002, and May 29, 2002, which concluded that Petitioner was not in substantial compliance with federal participation requirements. CMS Ex. 7.

3. Petitioner regained substantial compliance effective June 5, 2002.

4. Based on the February 20, 2002 survey, CMS cited Petitioner for failing to comply with the participation requirements found at: 42 C.F.R. �� 483.13(c)(1)(ii) (F 225 ⁽²⁾); 483.20(b) (F 272); 483.20(k) (F 279); 483.20(k)(2) (F 280); 483.25(c) (F 314); 483.25(h)(1) (F 323); 483.25(h)(2) (F 324); 483.25(l)(1) (F 329); and 483.25(l)(2) (F 330), two of which rose to the level of actual harm without immediate jeopardy and the remainder causing no actual harm but with the potential for more than minimal harm but not immediate jeopardy. ⁽³⁾ CMS Ex. 1.

5. Based on the May 16, 2002 survey, CMS cited Petitioner for failing to comply with the participation requirement found at 42 C.F.R. � 483.25(h)(2) (F 324) which resulted in immediate jeopardy to resident health and safety. CMS Ex. 2, 2A. ⁽⁴⁾

6. Based on the May 29, 2002 survey, CMS cited Petitioner for failing to comply with the participation requirements found at 42 C.F.R. �� 483.20(k)(3)(ii) (F 282) at the level of no actual harm but the potential for more than minimal harm, and 483.25(h)(2) (F 324) with actual harm but no immediate jeopardy. CMS Ex. 4, 4A.

7. Petitioner has not presented evidence on the merits of the deficiency findings from the February 2002 survey. Petitioner's Post Hearing Reply Brief (Petitioner's Response) at 2.

8. The alleged violation of 42 C.F.R. � 483.25(h)(2) (F 324) from the May 16, 2002 survey, as modified by the informal dispute resolution, involved these residents: Resident 23, Resident 5, and Resident 7; and an example related to Resident 7 was again cited as a violation on the revisit-survey of May 29, 2002. CMS Ex. 2A, 4A.

9. The alleged violation of 42 C.F.R. � 483.20(k)(3)(ii) (F 282) in the SOD dated May 29, 2002, as modified by informal dispute resolution, involved only Resident 25. CMS Ex. 4A.

10. On May 3, 2002, Resident 23 eloped from the facility and remained unsupervised outside on the facility's grounds between 3:13 p.m. and 3:50 p.m., when he was found by staff.

11. At the time of his elopement, Resident 23 was wearing a wandering patient transponder, a device that triggers the door lock and alarm system if a resident wearing it gets too close to a monitored door. ⁽⁵⁾

12. When investigating Resident 23's elopement, based on initial reports from staff that no alarm had sounded, the Petitioner's administration sought a mechanical or electrical failure to explain Resident 23's undetected elopement.

a. The facility's engineering staff conducted tests of the alarms at 4:38 p.m. on May 3, 2002, and found that the alarms were working.

b. Petitioner contacted the alarm vendor concerning the problem.

c. Petitioner conducted an elopement-related alarm drill with staff on May 4, 2002.

d. The alarm vendor tested the alarms.

e. Petitioner did not assess why the door through which Resident 23 eloped did not lock.

13. Petitioner learned that the charge nurse on duty on May 2, 2002, when Resident 23 eloped, heard the alarm sounding but admitted she did not respond appropriately, and she was disciplined by Petitioner for her failure.

14. The facility had an undated "Protocol for Roam Alert System" which required that staff check and redirect or remove residents who approached within 10 feet of a facility exit door triggering the door lock and alarm, but it did not specify what should be done if a resident was not observed in the vicinity of the door. CMS Ex. 15, at 23; P. Ex. 1, at Tab 8.

15. The facility's Director of Nursing issued a memorandum to facility staff dated May 6, 2002, which instructs staff, inter alia, to note which residents are on wandering precautions, and which residents are wearing transponder bracelets, and to respond quickly to alarms and to investigate, alarms, or make sure they have been investigated. P. Ex. 1, Tab 3.

16. Petitioner had a policy titled, "Missing Patient/Resident Alarm Guideline," which was "formulated" in January 2002, and revised on May 16, 2002, and, as revised, it required staff to locate the resident who triggered an alarm. CMS Ex. 15, at 23; P. Ex. 1, at Tab 8.

17. From May 16, 2002 to May 19, 2002, the facility conducted several inservice training sessions with staff concerning the facility's approach to resident safety risks from wandering related accidents. CMS Ex. 15, at 24-40.

18. Petitioner failed to establish how Resident 23 exited the facility on May 3, 2002, why the door did not lock, and why multiple staff failed to respond to a sounding alarm.

19. The facility prepared a care plan specifying that Resident 25 suffered from confusion that put her at risk from accidents related to wandering.

20. Resident 25's care plan called for at least six written interventions including frequent monitoring of Resident 25's whereabouts and placing reminder stop signs at the facility's exit doors.

21. The Nursing Assistant Care Plan required that staff check Resident 25 every 15 minutes as an anti-wandering precaution.

22. Resident 25 wore a wandering patient transponder or bracelet.

23. The facility did not place the stop signs at the exit doors as required by Resident 25's care plan.

24. Petitioner presented no evidence that the staff checked on Resident 25 every 15 minutes in accordance with the Nursing Assistant Care Plan.

25. On April 27, 2002, Resident 25 was found outside the facility after the door alarm was triggered by the resident's wandering resident transponder, but the automatic door lock did not engage the latch plate on the door frame which allowed Resident 25's exit.

26. Resident 7 was assessed by the facility as needing Posey® sleeve covers to prevent skin tears on her arms and legs.

27. The facility provided a skin assessment to Resident 7 on May 15, 2002, which revealed skin tears on the right leg and both arms (two on the left arm).

a. The nurse providing the skin assessment was unaware how Resident 7 had sustained the skin tears.

b. The facility's Assistant Director of Nursing indicated to the surveyor that Resident 7 often removed the Posey® sleeves.

c. The Assistant Director of Nursing reported to the surveyor that the sleeves were not an effective measure for protecting Resident 7, but that no new interventions had been introduced to protect Resident 7 from skin tears.

d. Resident 7 had been provided with air bolsters or air pillows to protect Resident 7 from injury sustained by contact with the bed side rails, however, the air bolsters or air pillows deflated regularly.

28. The facility took steps following the May 16, 2002 survey to alter the methods and interventions to protect Resident 7 and other residents from skin tears:

a. The air bolster/air pillows were replaced with alternate padding devices for all residents at risk for skin tears by May 17, 2002.

b. All nursing staff were trained in new skin tear treatment techniques by June 5, 2002.

29. CMS determined to impose a CMP of $250 per day for 84 days from February 20, 2002 through May 15, 2002; $5,000 per day for one day on May 16, 2002; and $250 for 19 days from May 17, 2002 through June 5, 2002.

30. There is no evidence of Petitioner's inability to pay the CMP imposed.

B. Conclusions of Law

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

2. I have jurisdiction to review the surveys ended February 20, May 16, May 29, and June 25, 2002 to determine whether there is a basis for the imposition of remedies and whether the proposed remedies are reasonable.

3. CMS provided sufficient notice that the deficiencies cited by the survey ended February 20, 2002 were a basis for the CMP.

4. Resident 23's elopement was an accident within the meaning of 42 C.F.R. � 483.25(h)(2).

5. Resident 7's skin tears were accidents within the meaning of 42 C.F.R. � 483.25(h)(2).

6. Petitioner violated 42 C.F.R. � 483.25(h)(2) (F 324) by not properly supervising Resident 23, which included staff's failure to respond to the alarm Resident 23 triggered.

7. Petitioner violated 42 C.F.R. � 483.25(h)(2) (F 324) by not properly supervising and providing assistance devices to Resident 7, including failing to implement protective sleeves on the resident's limbs and to monitor the effective use of those sleeves or to implement a more appropriate intervention to prevent skin tears.

8. CMS has made a prima facie showing of a violation of 42 C.F.R. � 483.25(h)(2) (F 324).

9. Petitioner has failed to rebut CMS's prima facie showing of a violation of 42 C.F.R. � 483.25(h)(2) (F 324) either by showing the facility was in substantial compliance or by presenting an affirmative defense.

10. Petitioner violated 42 C.F.R. � 483.20(k)(3)(ii) (F 282) by failing to provide services to Resident 25 in accordance with Resident 25's plan of care.

11. CMS has made a prima facie showing of a violation of 42 C.F.R. � 483.20(k)(3)(ii) (F 282).

12. Petitioner has failed to rebut CMS's prima facie showing of a violation of 42 C.F.R. � 483.20(k)(3)(ii) (F 282) either by showing the facility was in substantial compliance or by presenting an affirmative defense.

13. CMS's determination that the violation of 42 C.F.R. � 483.25(h)(2) presented immediate jeopardy to residents, for one day on May 16, 2002, is not clearly erroneous.

14. The period of DPNA was mandatory by operation of law because Petitioner's noncompliance lasted three months.

15. The mandatory loss of the facility's NATCEP was triggered, as a matter of law, by the imposition of a CMP of $5,000 and the extended or partial extended survey of May 16, 2002 (CMS Ex. 14, at 23).

16. A CMP of $250 per day for 84 days from February 20, 2002 through May 15, 2002; $5,000 per day for one day on May 16, 2002; and $250 for 19 days from May 17, 2002 through June 5, 2002, is reasonable.

III. ANALYSIS

A. Issues

The general issues are:

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

Whether the remedies imposed are reasonable.

B. Applicable Law

Petitioner is a long-term care facility participating in the federal Medicare program as a SNF and in the state Medicaid program 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 with authority to impose civil money penalties 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 ranges of penalties. 42 C.F.R. �� 488.408, 488.438. The upper range of CMP, 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).

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. U.S. Dept. of Health and Human Services, 363 F.3d 583 (6^th Cir. 2003). The Departmental Appeals Board (the Board) 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).

Pursuant to sections 1819(b)(5) and 1919(b)(5) of the Act, SNFs and NFs may only use nurse aides who have the required training and competency evaluation. Sections 1819(e) and 1919(e) of the Act impose upon the states the requirements to specify what NATCEPs they will approve that meet the requirements established by the Secretary and a process for reviewing and re-approving those programs using criteria set by the Secretary. Pursuant to sections 1819(f)(2) and 1919(f)(2) the Secretary was tasked to develop requirements for approval of NATCEPs 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 NATCEP offered by a SNF or NF that: (1) has been subject to an extended or partial extended survey under sections 1819(g)(2)(B)(I) or 1919(h)(2)(A)(ii) 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. "Substandard quality of care" is present when surveyors identify one or more deficiencies related to participation requirements established by 42 C.F.R. � 483.13 (Resident Behavior and Facility Practices), � 483.15 (Quality of Life), or � 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 previously 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 leads to loss of approval of the facility's NATCEP. 42 C.F.R. � 498.3(b)14.

When a penalty is proposed and appealed, CMS must make a prima facie case that the facility has failed to comply substantially with federal participation requirements. "Prima facie" means that the evidence is "(s)ufficient to establish a fact or raise a presumption unless disproved or rebutted." Black's Law Dictionary 1228 (8^th ed. 2004). See also, Hillman Rehabilitation Center, DAB No. 1611, at 8 (1997), aff'd Hillman Rehabilitation Center v. U.S. Dept. of Health and Human Services, No. 98-3789 (D.N.J. May 13, 1999). 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.

C. Discussion

1. I have jurisdiction to review the surveys ended February 20, May 16, May 29, and June 25, 2002 to determine whether there is a basis for the imposition of remedies and whether the proposed remedies are reasonable.

The survey cycle relevant to the issues in this case included an initial survey, concluded February 20, 2002, and three revisit surveys, concluded May 16, 2002, May 29, 2002, and June 25, 2002. In its May 22, 2002 letter, CMS notified Petitioner, inter alia, that a CMP of $250 was being imposed for the period February 20 through May 15, 2002. CMS Ex. 3. There is no dispute that the CMP for that period is based upon the deficiencies cited by the surveyors during the February 2002 survey. However, the parties dispute whether the February 20, 2002 survey is subject to my review or may be the basis for the imposition of remedies.

CMS argues that because Petitioner does not specifically challenge the findings of deficiencies from the February 20 survey, the "DAB lacks jurisdiction to review or upset these deficiencies in any regard; consequently, the deficiencies are final and non-reviewable by operation of law." CMS Brief at 5-7. CMS goes on to state that I must sustain a CMP against Petitioner in the amount of at least $50 per day. Id. Whether or not the findings of deficiency from the February 20, 2002 are "final and non-reviewable" as CMS asserts is not an issue I need to resolve. As discussed hereafter, Petitioner has not disputed those findings of deficiency and they may be approved upon a finding that there is prima facie evidence of a deficiency that is unrebutted in this case. However, Petitioner has not conceded but specifically challenges whether the deficiencies from the February 20 survey may be the basis for a remedy of any amount. CMS concedes based upon 42 C.F.R. � 488.438(e), that I have jurisdiction to review whether the deficiencies warrant a CMP of more than $50. Although not specifically acknowledged by CMS, it is required that I consider the deficiencies when determining the appropriate remedy pursuant to 42 C.F.R. �� 488.438(f) and 488.404. Thus, I conclude that I do have jurisdiction to review the deficiencies alleged by the survey ended February 20, 2002.

Petitioner makes three arguments to support its position that no enforcement remedies may be imposed based upon the survey concluded February 20, 2002: (1) CMS revised the proposed penalties and deleted the CMP for the period February 20, 2002 through May 15, 2002; (2) Petitioner's plan of correction for the deficiencies cited on the February survey was accepted and no penalties may be imposed based on the corrected deficiencies; and (3) CMS's notice regarding the nature of the noncompliance forming the basis for the remedies was defective. P. Brief at 13; P. Response at 3. None of Petitioner's arguments are persuasive.

Petitioner asserts that, based on the actions of the state agency surveyors and CMS following the February 20 survey, Petitioner believed that the findings made at the February 20 survey were adequately addressed through the plan of correction and no enforcement remedies should be based upon that survey or its findings. P. Brief at 14-15; Tr. 212, 216. As a result of the February 20, 2002 survey, the surveyors cited the facility for failing to comply substantially with nine different requirements of participation in Medicare and Medicaid. ⁽⁶⁾ By letter dated April 1, 2002, the state agency informed Petitioner that if the facility did not achieve substantial compliance with Medicaid and Medicare program requirements by April 25, 2002, the state agency would recommend to CMS that remedies, including a CMP, be imposed. CMS Ex. 25. The letter advised also that Petitioner was required to submit its plan of correction addressing the deficiencies by April 25, 2002, and the letter further indicated that the plan of correction would be subject to verification. Id. The facility did, in fact, submit a plan of correction addressing each of the nine alleged deficiencies dated April 22 and received on April 25, 2002, and that plan is found in the right column of the SOD at CMS Ex. 1. The facility alleged in its plan of correction that all of the corrective measures for all of the deficiencies cited would be in place by April 25, 2002. Id. The surveyors returned to the facility and conducted a revisit survey that concluded on May 16, 2002. CMS Ex. 2, at 1. The surveyors found that the facility was in violation of 42 C.F.R. � 483.25(h)(2)(F 324), which requires facilities ensure that residents receive adequate supervision and assistance devices to prevent accidents. ⁽⁷⁾ Following the May 16, 2002 survey, the state agency informed the facility by letters dated May 17 and 23, 2002, inter alia, that it would recommend to CMS that a $250 CMP be approved for the period February 20 through May 15, 2002, because Petitioner failed to achieve compliance after the February 2002 survey. CMS Exs. 16, at 1; 17, at 1. CMS explained in its letter to the facility dated May 22, 2002, that based upon receipt of Petitioner's plan of correction and credible allegation of compliance, the state agency suspended its recommendation for enforcement action. However, the survey ended May 16, 2002, found that Petitioner had not achieved substantial compliance as it had alleged and, in fact, an immediate jeopardy situation was discovered. CMS Ex. 3, at 2. CMS's letter informed the facility that it would impose a $250 per day CMP effective February 20, 2002 through May 15, 2002. Id. Given these facts, it is simply not credible that Petitioner believed that the February 2002 survey was no longer in issue after it submitted its plan of correction and allegation of compliance. Petitioner began operation as a long-term nursing facility in 1996; had experienced administrators; and had several surveys. Tr. 200, 215. The April 1, 2002 letter also clearly indicated that Petitioner's plan of correction and allegation of compliance was subject to verification. CMS Ex. 25. The state agency letters of May 17 and 23, 2002 and the CMS letter of May 22, 2002 also are clear that the revisit survey found that Petitioner was not in substantial compliance and that the February 2002 survey would be the basis for a CMP for the period February 20, 2002 through May 15, 2002.

Petitioner's argument, based upon the language of a June 5, 2002 CMS letter, that CMS revised its remedies and revoked or rescinded the CMP based on the February 2002 survey, is also without merit. Petitioner argues that CMS is precluded by its letter of June 5, 2002 from enforcing the penalties imposed by the CMS letter dated May 22, 2002. Specifically, Petitioner argues that CMS says in its June 5, 2002 letter that proposed remedies are "revised" and "reduced" and fails to mention the CMP of $250 per day for the period February 20 through May 15, 2002, indicating that CMS actually revoked that CMP. P. Brief at 13-14; P. Response at 3. The CMS letter of June 5, 2002 is clear and there can be no doubt as to the meaning and intent of the language:

As a result of your facility's continued noncompliance, the remedies that were imposed in our prior notices will remain in effect until your facility achieves substantial compliance or your Medicare/Medicaid provider agreements are terminated.

CMS Ex. 5, at 1. The foregoing language, which Petitioner seems to have overlooked, clearly shows that all the subsequent language in the letter about "revising" and "reducing" relates to reducing the $4,050 per day CMP to $250 per day, effective May 17, 2002, and continuing until substantial compliance was achieved or Petitioner was terminated. No where in its June 5 letter does CMS state that it is rescinding or revoking the previously imposed CMP of $250 per day for the period February 20 through May 15, 2002.

Finally, Petitioner's argument that the CMS notices were defective is also without merit. Petitioner is correct that 42 C.F.R. � 488.434(a)(2)(I) requires that CMS give notice of its intent to impose a CMP, and the notice must state the nature of the noncompliance that is the basis for imposition of the CMP. Petitioner argues that the May 16, 2002 survey (CMS Ex. 2) and the May 22, 2002 CMS letter (CMS Ex. 3) do not "describe" the deficiencies cited by the February 2002 survey. Therefore, Petitioner concludes that the deficiencies cited by the February 2002 survey may not be the basis for a CMP. P. Brief at 15-16; P. Response at 3. A careful and fair reading of the May 22, 2002 CMS notice belies Petitioner's argument. The second paragraph of the May 22, 2002 notice recites that a survey was conducted on February 20, 2002; that Petitioner was found not in compliance with participation requirements; and that a copy of the SOD from that survey had been previously provided to Petitioner. CMS Ex. 3, at 1. There is no allegation that Petitioner did not receive the SOD from the February 20, 2002 and, in fact, its plan of correction dated April 22, 2002 appears in the right column of that SOD. CMS Ex. 1. The third paragraph of the May 22, 2002 notice indicates that the state agency recommended enforcement remedies absent receipt of an acceptable plan of correction or achievement of substantial compliance. CMS Ex. 3, at 1. Under the paragraph entitled "Revisit," CMS advised that on revisit to verify that correction, the state agency found that Petitioner was not in substantial compliance and immediate jeopardy existed. Under the paragraph entitled "Mandatory Remedies," CMS advised that a DPNA must be imposed if substantial compliance was not achieved by Petitioner within three months after the survey that ended February 20, 2002. Id. at 2. Under the section of the notice entitled "Remedies Imposed," and "Civil Money Penalty (CMP)," CMS clearly advises that a CMP of $250 per day is being imposed for the period February 20, 2002 through May 15, 2002. The regulation does not require that the notice describe alleged deficiencies in detail, only that there be notice of the nature of the noncompliance alleged as the basis for the enforcement remedy. The May 22, 2002 notice makes clear that the noncompliance cited by the survey of February 2002 was a basis for the enforcement remedy proposed by CMS. The May 22, 2002 notice was adequate and Petitioner's arguments to the contrary are of no merit.

Based on the forgoing, I conclude that I have jurisdiction and the deficiency findings alleged by the February 20, 2002 survey may be the basis for the proposed CMP from February 20, 2002 through May 15, 2002.

2. Petitioner violated 42 C.F.R. � 483.13(c)(1)(ii) (Tag F 225), 42 C.F.R. � 483.20(b) (Tag F 272), 42 C.F.R. � 483.20(k) (Tag F 279), 42 C.F.R. � 483.20(k)(2) (Tag F 280), 42 C.F.R. � 483.25(c) (Tag F 314), 42 C.F.R. � 483.25(h)(1) (Tag F 323), 42 C.F.R. � 483.25(h)(2) (Tag F 324), 42 C.F.R. � 483.25(l)(1) (Tag F 329), and 42 C.F.R. � 483.25(l)(2) (Tag F 330), as alleged by the survey completed on February 20, 2002.

Other than Petitioner's contentions that no remedy may be imposed based upon the survey completed on February 20, 2002 that I have rejected, Petitioner does not rebut or present evidence of an affirmative defense as to any of the deficiencies alleged from that survey. Indeed, Petitioner concedes that it has not contested the merits of the deficiency findings from the February 20, 2002 survey. P. Response at 2. Based on my review of the record, including the findings set forth in the SOD dated February 20, 2002 (CMS Ex. 1) and the testimony at hearing (Tr. 124-194), I conclude that CMS presented a prima facie case that Petitioner failed to comply with the regulations alleged. I conclude, therefore, that Petitioner was in violation and failed to comply substantially with the requirements of participation as alleged in the SOD dated February 20, 2002.

3. Petitioner violated 42 C.F.R. � 483.25(h)(2) (Tag F 324) as alleged in the SODs dated May 16 and 29, 2002.

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 assistance 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. 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).

Pursuant to 42 C.F.R. � 483.25(h)(2), a facility must provide both "assistance devices" and "adequate supervision" to prevent accidents. Whether a facility's supervision or assistance 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. 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). 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 assistance devices to minimize risks that could lead to accidents. 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, Guidance to Surveyors, at PP-105, F324, Quality of Care (Rev. 274, June 1995), Woodstock Care Center, DAB No. 1726, at 4 (2000).

In the instant case, CMS alleged that the facility failed to meet the requirement to ensure supervision and assistance devices to prevent accidents as evidenced by the care provided to Residents 23 and 7. ⁽⁸⁾ CMS Exs. 2A, 4A. CMS has presented a prima facie case that Petitioner violated 42 C.F.R. � 483.25(h)(2) by showing that accidents and/or injuries occurred, i.e., CMS has produced sufficient evidence that, absent conflicting evidence, shows a violation occurred. See 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 by establishing an affirmative defense. Emerald Oaks, DAB No. 1800, at 16.

a. Resident 23

It is undisputed that on May 3, 2002, between about 3:10 p.m. (CMS Ex. 9, at 2) and 3:30 p.m. (Id. at 3, 9, 39), Petitioner's staff determined that Resident 23 was not in his room or visible on the unit. Resident 23 was found outside on the grounds of the facility at 3:50 p.m. lying face down. CMS Ex. 9, at 2, 9. There is no question that this 74-year-old resident with Parkinson's disease, moderately impaired decision-making skills, a history of falls, and a history of wandering behavior (CMS Ex. 12, at 9-10, 16, 20, 31, 33, 36-39; CMS Ex. 15, at 2), was not supposed to be outside the building alone. Resident 23 wore a wander alert bracelet that would trigger a door lock and an audible alarm if he approached any exterior door of the facility too closely. CMS Ex. 14, at 44-51; CMS Ex. 15, at 4-5; P. Brief at 2. Petitioner determined, based upon its examination of its wander alert system, that Resident 23 exited the facility by the north door on the C wing of building 5 at about 3:13 p.m. CMS Ex. 9, at 9; CMS Ex. 14, at 53. ⁽⁹⁾ Petitioner concluded in its initial investigation report dated May 9, 2002, that either the north door to C wing was obstructed or partially ajar and did not lock down, which allowed Resident 23 to elope. Id. at 10; P. Ex. 1, at Tab 5. Petitioner did not address in its report why the audible alarm did not sound or why no one apparently heard it. There is no question that Petitioner promptly reported the incident to state authorities. P. Brief at 5. The only reported injury to Resident 23 was an abrasion to his right chin or left cheek, depending upon which report you read. CMS Ex. 12, at 6, 39. On May 17, 2002, Petitioner prepared an addendum to its initial report of investigation, that includes the additional findings that LPN Betty Doig actually heard the alarm when Resident 23 left the building. Petitioner concludes that Nurse Doig did not respond appropriately to the alarm and the report indicates she was disciplined. CMS Ex. 15, at 7; P. Ex. 1, at Tab 9; see also CMS Ex. 14, at 55 and CMS Ex. 15, at 8 (Doig statements). The addendum does not mention that a housekeeper, Mary Madden, also heard the alarm and was the person who looked out the door where the alarm was triggered and silenced the alarm. CMS Ex. 14, at 14, 55, 56; CMS Ex. 15, at 8, 10. The addendum does not address that the clock system on the alarm was apparently incorrect. The addendum does not address why the door failed to lock and what was done to remedy that problem. The addendum also does not address the concern expressed by the administrator, Wade Stone, in response to my questioning. Mr. Stone testified:

Honestly, Your Honor, I did not, and to this day, I still cannot say that I understand why all of the staff who were questioned, which I think we questioned them exhaustively, whether it was myself or my director of nursing. I still don't understand how all those staff who were present that day could not have heard that alarm. Personally, my best guess is that they were covering for each other's hind ends and perhaps that. What Ms. Doing was doing, I'm not sure.

Tr. 248. The conspiracy of silence that Administrator Stone perceived is consistent with Betty Doig's statement that he took on May 17, 2002, in which at least one other nurse is identified who was with Nurse Doig at the nurse station at the time of the alarm.

The surveyors alleged in the SOD dated May 16, 2002 (CMS Ex. 2A) that Petitioner failed to provide adequate supervision to Resident 23 who had known wandering behaviors. The surveyors also alleged that Petitioner failed to adequately investigate the incident to determine the cause and required corrective action. Id. at 1. The surveyors alleged that despite the resident's known wandering behavior they found no care plan to address that behavior. Id. at 2. Petitioner has not presented a care plan dated prior to the May 3, 2002 elopement that addressed the problem of Resident 23's wandering behavior. Resident 23's care plan was amended or updated, however, on May 3, 2002 to cover his wandering behavior. CMS Ex. 12, at 15. There is no question that Resident 23 was wearing a wandering resident transponder at the time of his exit on May 3, 2002, even though there was no care plan. The surveyors also alleged in the SOD, that staff's failure to respond to the door alarm when Resident 23 exited and the failure of Petitioner to do a proper and thorough investigation of the cause of the incident and need for corrective action presented immediate jeopardy. CMS Ex. 2A, at 4.

I conclude that CMS has made a prima facie showing, based upon the undisputed facts, that Petitioner violated 42 C.F.R. � 483.25(h)(2) with regard to the incident involving Resident 23 who exited the facility unsupervised on May 3, 2002. ⁽¹⁰⁾ Petitioner's alarm/security system augmented Petitioner's supervision of its wandering residents by alerting staff to a possible exit and at the same time locking the door so elopement could not occur. Petitioner's use of the alarm and door-lock system reduced the need for staff to constantly observe facility exits and the location of wandering residents. Resident 23 wore a wandering resident transponder (either bracelet or anklet) on May 3, 2002. He was found outside the facility unsupervised. There is competent evidence that Resident 23 exited the facility through a door that had the alarm and locking system. I infer that the door did not lock as it should have when Resident 23 approached with his transponder, as there is no dispute that Resident 23 actually left the building through a door that should have locked. I accept Petitioner's speculation that the door did not lock due to some obstruction or because the door was left partially ajar - I have no evidence from which to draw a different conclusion. Furthermore, Petitioner does not dispute that in another incident involving Resident 25 on April 27, 2002, a door outfitted with the alarm and lock system also failed to lock allowing the resident to briefly exit the facility. P. Brief at 4. Given these facts, it is clear that Petitioner's supplemental supervision of its residents by use of the door alarm and automatic locking system was inadequate and/or defective. The human component of Petitioner's supervision was also defective. There is no doubt that at least two staff members, Nurse Doig and Housekeeper Madden, clearly heard the alarm but failed to initiate a search for Resident 23. Thus, the alarm component of Petitioner's supplemental supervision plan failed, not mechanically, but because two or possibly more staff simply did not respond to the alarm. While it is apparent that Petitioner promptly reported the incident to state authorities and investigated the incident, CMS is correct that the investigation was inadequate. Petitioner's focus was almost entirely upon the effectiveness of its high-tech alarm system and, as a result, Petitioner failed to identify the real defects and solutions. Given the foregoing, there is no question that CMS has made a prima facie showing of the deficiency. The issue is whether Petitioner has established a defense to the CMS prima facie showing of a violation.

Petitioner argues as its defense that it did everything it reasonably could do. P. Brief at 17-19; P. Response at 4-5. Petitioner asserts that at the time of his elopement, Resident 23 was wearing a wandering resident bracelet or transponder. P. Brief at 5-6. Petitioner contends that in the facility's investigation following Resident 23's elopement, the Director of Nursing was misled because she was initially informed by staff that the alarm did not sound. Based on this information, the facility pursued the possibility that some mechanical or electrical aspect of the alarm system had failed. According to Petitioner, the facility's engineering staff conducted a test of the alarms at 4:38 p.m. on May 3, 2002, and they found that the alarms were working. Petitioner indicates that it contacted the alarm vendor. The alarm vendor checked the system, recommended minor adjustments, and reminded Petitioner that the alarm system is not 100 percent foolproof and is only designed as an aid to staff for wandering residents. CMS Ex. 15, at 5. Petitioner conducted elopement-related alarm drills with staff on May 4, 2002. Petitioner learned on May 13, 2002, that the charge nurse who had been on duty on May 3, 2002 left a note for the Director of Nursing indicating that the alarm actually had sounded when Resident 23 eloped, but she (the charge nurse) had not responded appropriately. Id. Petitioner indicates that the charge nurse was disciplined by the facility as a result of this development. Id. at 6; Tr. at 222.

Petitioner argues that Resident 23's elopement was an unavoidable accident which occurred despite the facility having done "all that could be reasonably expected to prevent patients exhibiting wandering behavior from eloping from the facility." P. Brief at 19. Petitioner contends that it took all reasonable steps to protect Resident 23 including properly assessing Resident 23's risk for wandering, installing a system of electronic sensors to prevent elopements, installing an alarm system on each door, and equipping Resident 23 with the "wander guard" bracelet. Id. at 19. Petitioner asserts also that because its investigation ultimately revealed that the charge nurse on duty at the time of Resident 23's elopement belatedly reported that the alarm was triggered by Resident 23's elopement, and the charge nurse failed to respond to the alarm appropriately, the charge nurse is responsible for the elopement, not the facility. Id. at 5, 19. Petitioner argues further that to impose a remedy on the facility based on Resident 23's elopement would punish the facility "for the actions of a single employee who clearly violated existing facility policy and training." Id. at 20.

Petitioner's argument reveals to me that even as of hearing, Petitioner had not grasped the point of the deficiency finding. Petitioner relied upon its alarm and lock system to supervise its wandering residents, even though it should have known that the system alone was not 100 percent foolproof and was only designed as an aid to staff in supervising wandering residents. The evidence shows that on May 3, 2002, the lock on the door Resident 23 exited did not function as intended for some unknown reason, not addressed by any investigation or the parties at hearing, even though there is evidence that an automatic lock on another door failed less than a week prior. The evidence shows that Petitioner knew or should have known of a potential problem with the automatic locking of its doors. The evidence shows that the clock on the alarm and lock system was incorrect. The evidence shows that more than one of Petitioner's employees heard the alarm on May 3, 2002 and did not respond to it. The evidence shows that more than one of Petitioner's employees heard the alarm but failed to determine what triggered it or which resident was attempting to exit. The evidence shows that more than one of Petitioner's employees failed to identify that a resident had exited and which resident it was. The evidence shows that none of Petitioner's staff knew where Resident 23 was for an extended period despite the fact that his absence was clearly determinable from Petitioner's high-tech system. The evidence shows that more than one of Petitioner's staff did not know how to use or respond to its high-tech alarm system, no matter what training Petitioner conducted in the past. The evidence shows that Petitioner failed to properly address in a care plan the amount of supervision Resident 23 required so that its staff was on alert to the fact that supervision of a certain level was required. In short, the evidence shows multiple problems with Petitioner's system for supervising wandering residents. State agency surveyors found that Petitioner achieved substantial compliance on June 5, 2002, and I will not look behind that conclusion. However, my review of the evidence causes concern that even as of hearing, Petitioner had yet to fully address all issues raised by Resident 23's elopement and the possible conspiracy of silence among its staff. Petitioner's position, that it did all it "reasonably" could to prevent Resident 23's accidental elopement, may or may not be the correct legal standard. However, even by applying that standard, I conclude that Petitioner has shown no defense as it was not reasonable for Petitioner to almost totally rely upon its alarm and lock system for supervision of its wandering residents. It was not reasonable for Petitioner to fail to ensure that supervision would be provided for its wandering residents in case of failure of the high-tech supervision or the low-tech humans tasked to understand and maintain it.

The preponderance of the evidence shows that the facility placed its faith in the mechanical/electronic alarm part of its system and neglected to ensure the staff was prepared to use the system to adequately protect residents from harm associated with wandering and elopement. Accordingly, I conclude that the facility failed to do everything it could to prevent accidents related to wandering and elopement. This failure constitutes a failure to comply substantially with the requirement at 42 C.F.R. � 483.25(h)(2).

Petitioner failed to comply substantially with 42 C.F.R. � 483.25(h)(2) and, as a result, Resident 23 eloped from the building and remained unsupervised outside for 37 minutes, where the risk of serious harm or death was significantly greater than inside the facility. Petitioner then failed to adequately investigate and determine the cause for its failure of supervision of Resident 23 and potentially other wandering residents. I conclude, therefore, that CMS's determination of immediate jeopardy is not clearly erroneous.

b. Resident 7

Petitioner's records for Resident 7 show a history of skin tears to her extremities. CMS Ex. 11, at 2-6. Doctor's orders and nurse notes from May 14, 2002, show that one such tear to Resident 7's right arm just above her right elbow occurred when her air pillow or bolster for her side-rail deflated and her arm became trapped in the side-rail. Id. at 3 and 5. Her care plan, dated March 29, 2002, required side rail bolsters but an undated change shows a change from bolsters to having side rails padded; "Posey sleeve covers" on arms with a change dated May 15, 2002 that specifies "at all times" except for bathing; and notification of the charge nurse for any skin tears, among other things. Id. at 7. An undated "Nursing Assistant Care Plan" requires padded side rails when in bed and "skin sleeves, on at all times." Id. at 8.

The surveyor alleged in the SOD dated May 16, 2002, that at 1:30 p.m. on May 15, 2002, she observed Resident 7 with sleeve covers on each arm; that at 9:50 p.m. on May 16, 2002, she saw the resident without sleeve protectors on her arms; that a CNA asserted that the resident was wearing sleeve protectors but upon observation the resident was not and sleeve protectors could not be found in the resident's room. CMS Ex. 2A, at 8. The surveyor reported in the SOD that the Assistant Director of Nursing asserted that the resident often removed the sleeve protectors. Id. The surveyor reported that she observed skin tears on the right lower leg, left forearm, and right forearm of Resident 7. Id.

Petitioner does not dispute the accuracy of its records or the observations of the surveyor. P. Brief at 6, 21-22; P. Response at 6. Petitioner argues that immediately after the skin tear due to side rail contact on May 14, 2002, side rail padding was substituted for the air bolsters. Id. at 21-22. Petitioner makes no statement as to what was done about the care planned protective sleeves for the resident and her alleged noncompliance. Petitioner does not specifically address Resident 7 in the plan of correction found in the right column of the SOD. CMS Ex. 2A. Petitioner argues that there should be no "penalty" for the deficiency because no deficiency was cited on the February 20, 2002 survey related to skin tears. P. Response at 6. Resident 7 was cited as example 4 under tag F 272 related to an alleged failure of Petitioner to properly assess the resident for use of side rails. Although that example did not cite Petitioner for failure to provide the resident assistance devices to prevent skin tears, the surveyor reported in the SOD dated February 20, 2002 that a family member bought thigh-high TED hose for the resident to use to prevent skin tears to her lower extremities due to contact with side rails. CMS Ex. 1, at 5-6. There is no allegation in the February 20, 2002 survey that the hose or any other such protective device was not properly or consistently used, and I do not perceive the statements in Petitioner's briefs to be concessions that undiscovered deficiencies actually existed at the time of the February 2002 survey. Even if Petitioner concedes that it failed to use assistance devices and that failure was not discovered or simply not cited by the surveyors on the February 2002 survey, I do not see that as a defense to the failure to use the protective sleeves to assist in the prevention of skin tears to Resident 7's arms.

I do not find evidence that Petitioner corrected the deficiency with regard to Resident 7 prior to June 5, 2002, the date CMS and the state agency concluded that Petitioner was in substantial compliance. It is also clear that Resident 7 suffered actual harm in this case.

4. Petitioner violated 42 C.F.R. � 483.20(k)(3)(ii) (Tag F 282) as alleged in the SOD dated May 29, 2002.

The SOD dated May 16, 2002 (CMS Ex. 2A, at 6-7), originally included under the alleged violation of 42 C.F.R. � 483.25(h)(2) (tag F 324) an example 3 related to Resident 25. Informal dispute resolution resulted in the example related to Resident 25 being cited as a violation of 42 C.F.R. � 483.20(k)(3)(ii) (F 282) in the SOD dated May 29, 2002, rather than a violation of 42 C.F.R. � 483.25(h)(2). CMS Brief at 13; CMS Exs. 2A and 4A. The factual allegations do not appear to have been affected by the change. Title 42 C.F.R. � 483.20(k)(3)(ii) requires that the services provided or arranged by the facility must be provided by qualified persons in accordance with each resident's written plan of care.

It is alleged under tag F 282 that Resident 25 had a care plan that required frequent checks of her location and that "stop" signs were to be placed on doorways at each end of the building. CMS Ex. 4A, at 1. Resident 25's care plan dated January 1, 2001, shows that she was at risk for wandering from the facility due to confusion. Care planned interventions included reminding her not to leave the unit without staff or family; reminders, including "sign's 'stop' on doorways @ each end of building;" monitoring her whereabouts "frequently;" and reporting any change in cognitive ability. An undated change specified that she was to have a wandering resident "appliance & monitor wandering condition." CMS Ex. 13, at 2. A nurse note from April 20, 2002, reports that the resident was up in her wheelchair wandering the halls and trying to go out the exit door, with the resident redirected several times by staff. Id. at 3. A weekly nurse note from April 21, 2002, reports that Resident 25 "often attempts to open exit doors" causing the alarm to sound. Id. at 4. A nurse note dated April 27, 2002, reports that Resident 25 exited the facility but was redirected by a nurse just as she went out the door. Id. at 5, 8. A monthly nurse note dated May 2, 2002, indicates that a "wander guard" was attached to the resident's wheelchair "for safety measure." Id. An undated "Nursing Assistant Care Plan" requires as wandering precautions, that Resident 25 be checked every 15 minutes and that she wear an electronic monitoring bracelet at all times. Id. at 6-7. The gist of the deficiency cited under tag F 282 related to Resident 25 is that Petitioner failed to implement her written care plan, both because no stop signs were placed at exit doors and there was no record of frequent checks of her whereabouts. CMS Ex. 4A, at 1-2.

Petitioner admits Resident 25's attempted elopement on April 27, 2002, and that the door failed to automatically lock as it was supposed to. There is no dispute that Petitioner's staff did catch Resident 25 just as she exited the building due to the audible alarm and that the door was quickly fixed. P. Brief at 5, 21. Petitioner argues that it took all appropriate steps. However, Petitioner never addresses why it did not comply with its own care plan for Resident 25 to place stop signs at exit doors as an assistive device to remind her not to exit.

I conclude that CMS presented a prima facie case that the facility failed to comply substantially with the requirement that services be provided for Resident 25 in accordance with her plan of care. I conclude also that this failure presented the risk of more than minimal harm to Resident 25 from harm associated with wandering unsupervised and eloping from the facility. Petitioner has failed to rebut CMS's case by a preponderance of the evidence or to present evidence to show it corrected this deficiency prior to June 5, 2002, the date CMS and the state agency found that Petitioner returned to substantial compliance. Accordingly, I conclude that this deficiency provides a basis for the imposition of remedies against Petitioner.

5. A CMP of $250 per day for 84 days from February 20, 2002 through May 15, 2002; $5,000 per day for one day on May 16, 2002; and $250 per day for 19 days from May 17, 2002 through June 5, 2002 - a total CMP of $30,750.00 - is reasonable.

I have found that Petitioner violated multiple regulatory requirements for participation in Medicare and Medicaid during the period February 20, 2002 through June 5, 2002, and there is a basis for the imposition of remedies against Petitioner. Petitioner advanced several arguments in its brief concerning the duration and the reasonableness of the remedies that CMS seeks to impose. Petitioner argued that remedies are not justified for the period after May 17, 2002 because the measures necessary to correct the alleged deficiencies were in place before then. P. Brief at 24. Petitioner also argues that the remedies proposed by CMS are unreasonable, arbitrary, and capricious because CMS did not consider all the factors specified by the regulations for determining the appropriate amount of a CMP. Petitioner's arguments are not persuasive.

Petitioner argues that there is no basis for the CMP for the period of from May 17, 2002 through June 5, 2002. Contrary to Petitioner's plan of correction contained in the right column of the SOD dated May 29, 2002 (CMS Ex. 4A), which indicates correction as of June 5, 2002, Petitioner argues that measures that corrected the deficiencies cited concerning Resident 23, Resident 7, and Resident 25 were in place by May 17, 2002. Id. at 24-25. Petitioner asserts that Resident 7's care plan was updated and new interventions were implemented by May 17, 2002. P. Brief at 22, citing CMS Ex. 4A, at 3. However, I note that Petitioner also stated that "(b)y June 5, 2002, all nursing staff were retrained regarding these techniques [the new interventions for Resident 7]." P. Brief at 22, 25; P. Response at 6.

Petitioner asserts that the facility revised Resident 25's care plan to specify the frequency her whereabouts were to be checked, installed the stop signs required by her care plan, and took several other steps to ensure compliance with the requirements. Id. at 24. Petitioner concedes however that monitoring procedures were not in place until June 5, 2002.

By June 5, 2002, activities were in place to monitor compliance with the additional measures put into place May 17, 2002. Since the measures to correct the alleged deficiency were in place by May 17, 2002, any penalties should cease as of that time, and should not be extended merely because Turner later put monitoring procedures in place on June 5, 2002.

Id. Petitioner makes a similar concession regarding Resident 7:

The only thing that was not completed until June 5, 2002 was the education of nursing staff on transfer techniques. The measures taken by May 17, 2002 were totally adequate to address not only Resident 7's skin tears, but potential and actual skin tears of all residents. The fact that additional training was conducted thereafter should not serve to extend the penalties imposed on Turner.

Id. at 25.

The plan of correction submitted by the facility for the deficiency cited under tag F 282 provides:

The DON [Director of Nursing] will ensure that licensed staff monitor their respective nurse aide care plans for compliance. The Care Plan Team will review care plans quarterly to ensure specific and individualized interventions are appropriate for residents. The DON is responsible for this process.

CMS. Ex. 4A, at 2. Significantly, the plan of correction indicates that "[t]he completion date for this corrective action is June 5, 2002." Id. Concerning tag F 324 and Resident 7, the plan of correction lists the steps taken to attain compliance, and it indicates that some steps were completed or will be completed on May 15, 16, or 17, 2002. CMS Ex. 4A, at 3. The plan of correction states that the step - "care plans for residents identified with skin tears were reviewed and revised to ensure specific and individualized approaches to prevention and treatment of skin tears" - was not completed until June 5, 2002. Id. Moreover, the plan of correction states that the steps - training staff on transfer techniques and implementation of monitoring by the Care Plan Team and the Director of Nursing - were not completed until June 5, 2002. Id. at 4. In light of the facility's own planning for all corrective steps to be completed by June 5, 2002, and absent any evidence all corrective actions were completed prior to June 5, 2002, I find Petitioner's argument - which appears to be an effort to recast some of the corrective measures to have been not essential - unpersuasive.

Petitioner's argument that the amounts of the CMP are unreasonable and or arbitrary and capricious because CMS failed to consider or failed to adequately consider the regulatory factors is unavailing. It is not for me to review how CMS exercises its discretion and determines the amount of a CMP to propose. My review of the reasonableness of a proposed CMP is de novo, i.e., I make an independent determination as to the reasonableness of a CMP based upon the evidence and regulatory factors. 42 C.F.R. � 488.438(e).

The applicable range of CMPs for non-immediate jeopardy deficiencies is $50 to $3,000 per day. A $250 per day CMP for most of the period at issue in this case is therefore in the bottom fifth of the range of possible penalty amounts. The applicable range of CMP for the immediate jeopardy deficiencies is $3,050 to $10,000 per day. The $5,000 per day CMP assessed for the one day of immediate jeopardy is in the middle of the range of possible penalties.

In determining a reasonable 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.

I have no evidence of a history of violations by Petitioner except the evidence related to the survey cycle before me. I note that the February 2002 survey included an undisputed finding of a violation of 42 C.F.R. � 483.25(h)(2) based upon lack of or ineffective supervision and assistance devices resulting in or contributing to falls and skin tears with actual harm to residents. I have concluded, consistent with the allegations in the May 16, 2002 SOD, that Petitioner was subsequently in violation of 42 C.F.R. � 483.25(h)(2) due to inadequate supervision and use of assistance devices leading to actual harm and immediate jeopardy for facility residents. The facility has not alleged inability to pay or submitted evidence of such inability. I do find that Petitioner was culpable with regard to the deficiencies cited in the SODs dated February 20, May 16 and 29, 2002 and discussed in detail in this decision. ⁽¹¹⁾ Petitioner offers no acceptable explanation for why staff was permitted to ignore care planned interventions. Petitioner also offers no acceptable explanation for how it failed to determine the true facts related to an elopement or how it failed to deal with the conspiracy of silence among staff that the Administrator suggests existed. The seriousness of the deficiencies is reflected by the discussion of those deficiencies. There was immediate jeopardy for one day and there was actual harm to the residents involved, and the potential for actual harm was not abated until Petitioner completed its corrective action. I conclude that the amounts of the CMP are reasonable.

Finally, both the DPNA and the loss of the NATCEP remedies are mandatory by operation of law. The period of DPNA was mandatory by operation of law due to the period of Petitioner's noncompliance having lasted three months. 42 C.F.R. �� 488.412(c); 417(b)(1). The mandatory loss of the facility's NATCEP was triggered, as a matter of law, by the imposition of a CMP of $5,000 and the extended or partial extended survey of May 16, 2002 (CMS Ex. 14, at 23). By regulation, the State had no choice but to deny or withdraw approval for a period of two years after the May 16, 2002 survey. 42 C.F.R. � 483.151(b)(2) and (e)(1).

IV. CONCLUSION

For the foregoing reasons, I conclude that Petitioner violated multiple regulatory requirements for participation in Medicare and Medicaid during the period February 20, 2002 to June 5, 2002. I also conclude that a CMP of $250 per day for 84 days from February 20, 2002 through May 15, 2002; ⁽¹²⁾ $5,000 per day for one day on May 16, 2002; and $250 per day for 19 days from May 17, 2002 through June 5, 2002 - a total CMP of $30,750.00 - is reasonable.

Keith W. Sickendick

Administrative Law Judge

1. All references are to the revision of the Code of Federal Regulations (C.F.R.) in effect at the time of the surveys, unless otherwise indicated.

2. This is a "Tag" designation that refers to the part of the State Operations Manual, Appendix P, "Survey Protocol for Long Term Care Facilities," "Guidance to Surveyors" that pertains to the specific regulatory provision allegedly violated.

3. The cited deficiencies are set forth in a Statement of Deficiency, Form 2567L (SOD) prepared by the state surveyors. Each deficiency includes a scope and severity (SS) level such as "SS=D." See, e.g., CMS Ex. 1, at 1 (left column). Scope and severity levels are used by CMS and a state agency 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.

4. CMS exhibits 2A and 4A are revised SODs issued to reflect the result of informal dispute resolution conducted on July 15, 2002. CMS Ex. 2A at 6; CMS Post Hearing Brief (CMS Brief) at 13.

5. This system is referred to at the hearing and in briefing as a "wander guard" bracelet or transponder. WanderGuard� is a similar system, but it does not appear to be the actual system used by Petitioner. CMS Ex. 15, at 4; Petitioner's Post Hearing Brief (P. Brief) at 2.

6. The deficiency findings are identified as numbered tags in the left column of the SOD. The specific tags cited are F 225, F 272, F 279, F 280, F 314, F 323, F 324, F 329, and F 330. CMS Ex. 1.

7. Petitioner was also cited with a violation of 42 C.F.R. � 483.25(h)(2) on the survey ended February 20, 2002, but based upon different examples. CMS Ex. 1, at 20.

8. The SOD dated May 16, 2002, under tag F 324 includes an example 2 with allegations related to Resident 5. CMS presented no argument concerning Resident 5 in its post hearing briefs. I conclude, based on CMS's silence, that CMS does not intend to pursue the example related to Resident 5, and I make no findings or conclusions related to the allegations of the survey related to that resident. Informal dispute resolution resulted in the example related to Resident 25 being cited as a violation of 42 C.F.R. � 483.20(k)(3)(ii) (F 282) rather than a violation of 42 C.F.R. � 483.25(h)(2), as originally cited in the SOD dated May 16, 2002. CMS Brief at 13; CMS Exs. 2A and 4A.

9. According to the statement of one nurse, the system actually showed an alarm at 1:13 p.m. but, after examination by a technician, it was determined that the clock on the alarm system was two hours behind. Id.

10. The deficiency, as alleged, includes allegations related to care planning and the thoroughness of the investigation, allegations that might have also been cited as violations of other regulations. Those allegations are considered in the context of the alleged violation of 42 C.F.R. � 483.25(h)(2) as they relate to the adequacy of assistance devices and supervision and not as separate regulatory violations because they are not alleged as such.

11. Not discussed in detail in this decision, but considered as they relate to an appropriate CMP, are the undisputed violations from the February 20, 2002 survey that included: failure to report alleged abuse (F 225); failure to do a proper assessment related to the use of side rails and insomnia (F 272); failure to develop and implement care plans related to falls, use of side rails, development of pressure sores, and skin tears (F 279); failure to revise a care plan (F 280); failure to prevent the development of avoidable pressure sores (F 314); failure to ensure that resident environment was as free of accident hazards as possible (F 323); failure to provide adequate assistance devices and supervision to prevent accidental falls and skin tears (F 324); failure to properly assess a resident for symptoms of insomnia prior to initiating use of a hypnotic drug (F 329); and failure to ensure that an anti-psychotic drug was not used without the diagnosis and documentation of a specific condition (F 330). Some of these deficiencies involved actual harm to residents.

12. In determining the total number of days subject to the CMP, I begin counting with February 21, 2002 (the first full day of noncompliance) and stop counting on June 4, 2002 (the facility was substantially compliant on June 5, 2002). See 42 C.F.R. � 488.440.