SUBJECT:

Willow Creek Nursing Center, Inc.,

Petitioner,

Centers for Medicare & Medicaid Services.

DECISION

Petitioner, Willow Creek Nursing Center (Petitioner or facility), is a long term care facility certified to participate in the Medicare and Medicaid programs as a provider of services. Following a federal survey completed May 27, 2004, the Centers for Medicare & Medicaid Services (CMS) determined that, from May 7 through 24, 2004, the facility was not in substantial compliance with a number of program requirements. Petitioner has appealed just two of the alleged deficiencies: 42 C.F.R. � 483.25(h)(2) (quality of care - failure to prevent accidents) and 42 C.F.R. � 483.75 (administration). CMS asserts that these deficiencies posed immediate jeopardy to resident health and safety, and has imposed a $3,050 per day civil money penalty (CMP).

The parties have agreed that this matter may be decided on the written record, without an in-person hearing. For the reasons set forth below, I find that the facility substantially complied with the requirements in question; therefore its deficiencies did not pose immediate jeopardy to resident health and safety, and CMS had no basis for imposing the $3,050 per day CMP.

I. Background

Following a survey conducted from May 24 through 27, 2004, federal surveyors concluded that the facility was not in substantial compliance with federal requirements for nursing homes participating in the Medicare and Medicaid programs. Among other deficiencies, they charged that the facility did not meet federal requirements under 42 C.F.R. � 483.25(h)(2) (Tag F-324 - Quality of Care) and 42 C.F.R. � 483.75 (Tag F-490 - Administration) at a "J" level of scope and severity (immediate jeopardy to resident health and safety). CMS Exhibit (Ex.) 1, at 11-20, 26-27.

In a letter dated June 7, 2004, CMS advised the facility that it was not in substantial compliance, that its deficiencies posed immediate jeopardy to resident health and safety, and that CMS was imposing a CMP of $3,050 per day effective May 7 through May 24, 2004 (total $54,900). For its non-immediate jeopardy deficiencies, CMS imposed a CMP of $200 per day effective May 25, 2004. CMS Ex. 42, at 1-4. Following a revisit survey completed August 4, 2004, CMS determined that the facility had achieved substantial compliance as of June 11, 2004. CMS Ex. 42, at 8.

Petitioner timely requested a hearing, limiting its appeal to the two immediate jeopardy tags and the penalties associated with them. ⁽¹⁾ The case was assigned to me.

After filing their initial briefs (P. Pre-hearing Brief and CMS Pre-hearing Brief) and submissions, the parties agreed to resolve this case on their written submissions, without an in-person hearing. See Petitioner's Second Supplemental Memorandum (P. 2d Supp. Mem.) at 1 and August 4, 2005 letter transmitting P. 2d Supp. Mem.; CMS Final Brief (CMS Final Br.) at 1; 42 C.F.R. � 498.66 (waiver of right to appear and present evidence). Pursuant to agreement of the parties, the parties filed final briefs (P. 2d Supp. Mem. and CMS Final Br.), and reply briefs (P. Reply and CMS Reply). CMS has filed 45 exhibits (CMS Exs. 1-45). Petitioner has filed 17 exhibits (P. Exs. 1-17). In the absence of any objections, I admit CMS Exs. 1-45 ⁽²⁾ and P. Exs. 1-17.

II. Issues

The case therefore presents the following questions:

1. Whether, from May 7 through 24, 2004, the facility was in substantial compliance with program participation requirements for facilities participating in the Medicare and Medicaid programs, specifically 42 C.F.R. � 483.25(h)(2) and 42 C.F.R. � 483.75.

2. If the facility were not in substantial compliance, I would consider whether its conditions posed immediate jeopardy to resident health and safety.

Had I found substantial noncompliance at the immediate jeopardy level, I would sustain the amount of the CMP since the statutory minimum per day CMP in an immediate jeopardy situation is $3,050.

III. Statutory and Regulatory Background

The Social Security Act (Act) sets forth requirements for nursing facility participation in the Medicare and Medicaid programs, and authorizes the Secretary of Health and Human Services to promulgate regulations implementing the statutory provisions. Act, sections 1819 and 1919. The Secretary's regulations governing nursing facility participation in the Medicare program are found at 42 C.F.R. Part 483. Facilities must maintain substantial compliance with program requirements, and, to be in substantial compliance, a facility's deficiencies may pose no greater risk to resident health and safety than "the potential for causing minimal harm." 42 C.F.R. � 488.301.

Under the statute and "quality of care" regulation, each resident must receive and the facility must provide the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the resident's comprehensive assessment and plan of care. Act, section 1819(b); 42 C.F.R. � 483.25. Accordingly, the facility must conduct an initial and periodic resident assessment of functional capacity that is comprehensive, accurate, standardized, and reproducible. 42 C.F.R. �� 483.20, 483.25. The facility must also make a comprehensive assessment of a resident's needs promptly after a significant change in the resident's physical or mental condition. 42 C.F.R. � 483.20(b)(2)(ii).

The facility must ensure that each resident receives adequate supervision and assistance devices to prevent accidents. 42 C.F.R. � 483.25(h)(2). 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)." State Operations Manual (SOM) Appendix PP, Guidance to Surveyors, Part 2, SOP 483.25 Quality of Care (Rev. 274, June 1995); see Woodstock Care Center, DAB No. 1726, at 4 (2000), aff'd Woodstock Care Center v. Thompson, No. 01-3889 (6^th Cir. Nov. 17, 2003) (unpublished).

Immediate jeopardy exists if the facility's noncompliance has caused or is likely to cause "serious injury, harm, impairment, or death to a resident." 42 C.F.R. � 488.301. CMS's determination as to the level of a facility's noncompliance - which includes its immediate jeopardy finding - must be upheld unless it is "clearly erroneous." 42 C.F.R. � 498.60(c).

If a facility is not in substantial compliance with program requirements, CMS has the authority to impose one or more of the enforcement remedies listed in 42 C.F.R. � 488.406, which include imposing a CMP. See Act, section 1819(h). CMS may impose a CMP for the number of days that the facility is not in substantial compliance with one or more program requirements or for each instance that a facility is not in substantial compliance. 42 C.F.R. � 488.430(a). In situations where the deficiencies do not constitute immediate jeopardy, but have caused actual harm or have the potential for more than minimal harm, CMS may impose a CMP in the lower range of $50 to $3,000 per day. Penalties in the range of $3,050 to $10,000 per day are imposed for deficiencies constituting immediate jeopardy. 42 C.F.R. � 488.438.

IV. Discussion

A. From May 7 through 24, 2004, the facility was in substantial compliance with the program participation requirement set forth at 42 C.F.R. � 483.25(h)(2). ⁽³⁾

The quality of care regulation, 42 C.F.R. � 483.25, imposes on facilities an affirmative duty designed to achieve favorable outcomes "to the highest practicable degree." Windsor Health Care Center, DAB No. 1902, at 16-17 (2003); Woodstock Care Center, DAB No. 1726, at 25-30. Among other specific requirements, the facility is required to "take reasonable steps to ensure that a resident receives supervision and assistance devices designed to meet his or her assessed needs and to mitigate foreseeable risks of harm from accidents." 42 C.F.R. � 483.25(h)(2); Windsor Health Care Center, DAB No. 1902, at 5; Asbury Center at Johnson City, DAB No. 1815, at 12 (2002); Woodstock Care Center, DAB No. 1726, at 25. The regulation requires the facility to anticipate what accidents might befall a resident and to take steps - increased supervision or the use of assistance devices - to prevent them. Guardian Health Care Center, DAB No. 1943, at 18 (2004).

A facility is permitted the flexibility to choose the methods it uses to prevent accidents, but the chosen methods must constitute an "adequate" level of supervision under all the circumstances.

Windsor Health Care Center, DAB No. 1902, at 5.

This case centers around the facility's efforts to protect one of its residents, R4, from accidents. When he was admitted to the facility on March 12, 2004, R4 was 91 years old, suffering from, among other things, diverticular disease, renal insufficiency and Alzheimer's disease. He was ambulatory and alert, but quite confused. P. Ex. 1 at 1, 9, 13, 44-45. The facility identified him as a wanderer, at risk for elopement, and fitted him with a Wander Guard bracelet. P. Ex. 1, at 38, 46, 86, 99, 116, 170, 321. ⁽⁴⁾ Staff developed a written care plan to address his wandering behavior, with the goal of preventing injury or harm to himself or others. P. Ex. 1, at 119-120. Interventions included instructions to staff on how to approach and interact with R4, finding him diversional activities, frequently monitoring his whereabouts and activities, as well as staying alert for door alarms. Id.

R4's treatment records document his efforts to exit the facility. A nursing note dated April 25, 2004, for example, indicates that he "wants to try to get out of the side door to get 'home'," but was redirected. P. Ex. 1, at 64; CMS Ex. 12, at 14. On April 29, 2004, he is described as "constantly" at the nurses station, asking, "Why am I here?" and saying that he "can't get out," and that his "wife is waiting." He was redirected each time. Id. A note dated May 1, 2004, indicates that he continues to try to get out of the side doors, saying "I'm going home" and "Why do you keep me here?" The nurse spoke to him and "redirected." Id.

CMS bases its case on a series of incidents in which R4 hovered around an exit door, attempted to elope, and, on four occasions, managed to get out the door, setting off the alarm. According to CMS, an elopement occurs when a resident, who is cognitively impaired or not capable of protecting himself from harm, exits the facility unsupervised without staff knowledge. CMS Final Br. at 9 n.2, citing CMS Ex. 43, at 2 (Holloway Amended Decl. � 6). I do not disagree with this definition. ⁽⁵⁾ CMS also claims that R4 exited the facility "without being observed by staff" four times: on May 7, 18, 20, and 25. CMS Final Br. at 15; CMS Ex. 43, at 4 (Holloway Decl. � 15). But that is not what the records show. As Petitioner argues, and any reasonable review of the evidence establishes, R4 never departed the building undetected or unsupervised, and he never entered into harm's way. In fact, the opposite is true. The evidence establishes that staff implemented the interventions listed in R4's care plan, and that those interventions effectively protected R4 from harm.

There seems little dispute as to the critical facts surrounding these incidents, most of which are set forth in R4's treatment record. On May 7, 2004, at 12:20 p.m., the nurses notes describe R4 as "continuously ambulating to exit doors, attempting to go out." Staff explained that he needed to be at the facility, but he continued pacing the hallway, saying "No, I got to go home." Staff contacted his physician and obtained a new treatment order, presumably the psychotropic medication, Zyprexa. P. Ex. 1, at 36, 63; CMS Ex. 12, at 13. The nurses notes then describe what CMS characterizes as R4's first "elopement:" at 1:50 p.m. on May 7, he went to the exit door next to his room. The Wander Guard alarm went off. He walked out the door, followed by four nurses. One of the nurses reached him as he stepped onto the grass, and returned him to the facility. Staff called his family, who spoke to him and calmed him down. P. Ex. 1, at 63; CMS Ex. 12, at 13.

Dana Wiley is a licensed practical nurse (LPN) working in the facility at the time of this and the other incidents. P. Ex. 9, at 1 (Wiley Decl. �� 1, 4). According to LPN Wiley, after lunch on May 7, 2004, she watched R4 as he approached the exit door near his room. As he pushed the door, his Wander Guard sounded the alarm. She and three other staff members walked toward R4, attempting to redirect him, but he stepped outside. At no time was he out of staff's sight. They brought him back into the facility, and LPN Wiley called his family. His grandson's wife spoke to him by telephone, calming him down. Staff directed him back to his room where he sat in his recliner until his grandson arrived for a visit. P. Ex. 9, at 1 (Wiley Decl. � 5). Nothing in the record suggests that this eyewitness account does not accurately describe the May 7 event.

I do not consider R4's leaving the facility with four nurses on his heels to have placed him in any jeopardy. It appears that the intervention the facility had in place successfully prevented an elopement.

The second incident CMS cites is also described in the nurses notes. On May 18, 2004, R4 approached the nurse asking why he could not go home. She told him that his grandson wanted him to stay, and he became upset. He paced around at the desk for a while, then went behind the nurses station to the outside door. He stood there for a while, and then went outside. The social worker got him as he was running along the outside of the building, and brought him back in without further incident. P. Ex. 1, at 62; CMS Ex. 12, at 12. By the surveyor's measurements, this was just twelve feet from the exit door. CMS Ex. 44, at 4 (Richardson Decl. � 8(j)). Again, LPN Wiley observed the incident. She reports that the door alarm sounded as R4 pushed on it, and staff, including LPN Wiley, "immediately responded," arriving at his side while he stood on the sidewalk, approximately twelve feet from the building. They attempted to calm him. He cooperated and returned to the building to relax in his room. P. Ex. 9, at 2 (Wiley Decl. � 6).

On May 20, 2004, R4 again went out the hall door, and one of the nurses and her supervisor got to him, and encouraged him to come back in, which he reluctantly did. P. Ex. 1, at 62; CMS Ex. 12, at 12. According to LPN Wiley, staff reached R4's side just as he stepped across the threshold, and persuaded him to return to the facility. P. Ex. 9, at 2 (Wiley Decl. � 7). Again, nothing in the record casts any doubt on this statement.

A note dated May 25, 2004, at 4:05 p.m., indicates that the nurse heard the door alarm sound, and saw the resident standing in the hall doorway with the door open. He went out the door, and a nurse went after him. When he resisted her efforts to return through the same door, she walked arm-in-arm with him around the facility, explaining that he could not walk home in the heat, and he agreed to go back into the facility through the front door. Thereafter, staff called his doctor, who again adjusted his medication. P. Ex. 1, at 61. LPN Wiley was the nurse involved in this incident. She notes that staff immediately responded to the alarm, and that she reached him as he put one foot across the threshold. Because he was reluctant to return to the building, she walked arm-in-arm with him around the building, and, when they reached the front door, he was amenable to returning. "At no time was the resident outside the building without being in direct physical contact with me." P. Ex. 9, at 2 (Wiley Decl. � 8). Surveyor Richardson was sitting at the nurses station when the Wander Guard alarm went off, and her testimony confirms LPN Wiley's account. CMS Ex. 44, at 6 (Richardson Decl. � 8(q)). According to her testimony, R4 had opened the door and was standing in the doorway as the administrator and staff approached him. She suggests some fault because staff "had to walk [him] around to the front of the building to get him to come inside," but I can find no fault with the staff's response. LPN Wiley effectively managed to keep him safe, calm him down, and return him to the facility. Indeed, her actions were consistent with the instructions in R4's care plan: she gently touched him, assessed his needs, asked him to verbalize his needs, and continued to talk about his needs while walking him to a safe area. See P. Ex. 1, at 119.

I do not see that any elopement or other accident occurred here. Nor do I find unreasonable the facility's efforts to prevent accidents. The evidence establishes that the facility's implementation of an alarm system - which staff checked regularly (P. Ex. 1, at 184, 192, 200, 208) - and the staff's immediate response to the sounding of a door alarm effectively prevented R4 from exiting the facility undetected. Moreover, I find fully credible Petitioner's assertions that staff were appropriately trained and that R4 was closely monitored, as reflected by their immediate and appropriate responses to the sound of the alarm going off, and their consistent successes in preventing R4 from eloping. P. Ex. 7, at 2-3 (Latham Decl. �� 7, 8, 9); P. Ex. 8, at 2 (Shelton Decl. �� 5, 6, 7); P. Ex. 9, at 2-3 (Wiley Decl. �� 9, 10, 11, 12); P. Ex. 10, at 1-2 (Evans Decl. �� 3, 4, 5).

This is simply not a situation in which a resident's whereabouts were unknown for any period of time. Nor was staff ignorant of or indifferent to its responsibility to keep R4 safe. I am aware of no case or other authority - and CMS has pointed to none - in which we have held a facility to the standard that CMS proposes here. Contrast this situation with those presented in other "elopement" cases. Lake Park Nursing and Rehabilitation Center, DAB CR1341 (2005), for example, presented multiple instances of a wandering resident suffering real injury. The facility was unable to explain when, within hours, the resident's injuries occurred. When door alarms went off, staff did not understand how to respond, which allowed the resident to exit successfully. She ended up lying injured in a ditch. Staff learned of her absence only when notified by a passer-by. See also, Asbury Center at Johnson City, DAB No. 1815 (2000) (no supervision of wandering resident for at least 20 minutes prior to her getting through an exit door and falling down a flight of steps; all of the nurse aides were absent from the secure unit when a second resident got through an exit door and fell down a flight of steps; alarm system failed); Aase Haugen Homes, Inc., DAB CR1273 (2005) (alarm system failed, and staff was unaware of resident's elopement until advised by a neighbor; in a second instance, an alarm sounded but staff did not respond appropriately and was unaware of resident's elopement until notified by a neighbor); Cal Turner Extended Care Pavilion, DAB CR1315, at 14 (2005) (charge nurse failed to respond when she heard an alarm, and resident eloped and was unsupervised on facility grounds from 3:13 p.m. until 3:30 p.m.; second resident found outside after the door alarm system malfunctioned); Weatherford Health Care Center, DAB CR1139 (2004) (staff unaware of resident's elopement until advised by his daughter that he had been killed four miles from the facility; staff failed to perform required bed check and falsified records to claim that they did).

The evidence here establishes that R4 was well-supervised, and the facility was in substantial compliance with 42 C.F.R. � 483.25(h)(2). Because the facility was in substantial compliance, no question remains as to whether its conditions posed immediate jeopardy to resident health and safety.

B. From May 7 through 24, 2004, the facility was in substantial compliance with the program participation requirement set forth at 42 C.F.R. � 483.75.

A finding of noncompliance with the requirement that a facility be administered in a manner that "enables it to use its resources effectively and efficiently to attain or maintain the highest practicable physical, mental, and psychosocial well-being of each resident" derives from findings of substantial noncompliance in other areas. Asbury Center at Johnson City, DAB No. 1815. In this case, to support its claim that the facility did not comply with the requirements governing administration, CMS relies on the same facts underlying its claim that the facility did not comply with the quality of care regulation. Thus, because I do not sustain CMS's allegation of noncompliance on the underlying deficiency (42 C.F.R. � 483.25(h)(2)), I cannot sustain a finding of substantial noncompliance with the administration regulation, 42 C.F.R. � 483.75.

V. Conclusion

For the reasons discussed above, I find that Petitioner substantially complied with program participation requirements governing quality of care (42 C.F.R. � 483.25(h)(2)) and administration (42 C.F.R. � 483.75). Its deficiencies did not pose immediate jeopardy to resident health and safety, and CMS therefore had no basis for imposing a $3,050 per day CMP.

Carolyn Cozad Hughes

Administrative Law Judge

1. Petitioner does not challenge the remaining deficiencies, and was therefore not in substantial compliance with program requirements from May 7 through June 10, 2004. It is unquestionably subject to the $200 per day penalty imposed from May 25 through June 10. With respect to the amount of the penalty imposed from May 7 through May 24, however, the penalty amount is not so readily apparent. The penalty must be at least $50 per day (42 C.F.R. � 488.438); however, CMS has not specified the exact amount for the non-immediate jeopardy deficiencies during this period.

2. CMS Ex. 45 (Eckhardt Declaration) was filed as a supplement, pursuant to agreement of the parties. At the same time, CMS filed amended versions of Exhibits 43 (Holloway Declaration) and 44 (Richardson Declaration). The record is somewhat confusing because CMS has neither designated these as amended exhibits nor dated any of its declarations. I understand the amended and final version of CMS Ex. 43 is distinguishable from the earlier version because it is 10 pages long while the earlier version was 11 pages long. Both versions of CMS Ex. 44 are nine pages long, but the amended (and final) version is distinguishable from the earlier one because it contains more text on page 8. I admit the amended and final versions of CMS Exs. 43 and 44.

3. I make Findings of Fact and Conclusions of Law (Findings) to support my decision in this case. I set forth each Finding, in italics and bold, as a separate heading.

4. The Wander Guard system is designed to alert the staff when a resident attempts to elope. A bracelet transmitter attached to the resident's wrist or ankle sets off a door alarm if the resident attempts to exit the facility.

5. For reasons that I do not understand, CMS criticizes Petitioner for relying on this same definition of elopement. In defining elopement, Petitioner quotes public remarks made by a program manager from the South Carolina Bureau of Certification, which is the state survey agency. While I understand that the government may not be bound by erroneous information provided by its agents, I do not understand challenging a position that is consistent with the federal position simply because it has been attributed to someone who is arguably an agent of the federal government. See CMS Final Br. at 18 et seq.