SUBJECT: Willow Creek Nursing Center,

Petitioner,

Centers for Medicare & Medicaid Services

FINAL DECISION ON REVIEW OF
ADMINISTRATIVE LAW JUDGE DECISION

On November 25, 2005, the Centers for Medicare & Medicaid Services (CMS) appealed the September 26, 2005 decision of Administrative Law Judge (ALJ) Carolyn Cozad Hughes overturning CMS's imposition of a $3,050 per day civil money penalty (CMP) on Willow Creek Nursing Center (Willow Creek) for the period May 7 through 24, 2004. Willow Creek Nursing Center, Inc., DAB CR1351 (2005) (ALJ Decision). CMS imposed the $3,050 per day CMP following a survey that found two immediate jeopardy-level deficiencies based on Willow Creek's treatment of one resident (R4) who repeatedly attempted to elope from the facility. Specifically, the survey found that Willow Creek failed to substantially comply with Medicare participation requirements at 42 C.F.R. § 483.25(h)(2) and 42 C.F.R. § 483.75. CMS argues on appeal that the ALJ erred in concluding that Willow Creek was in substantial compliance with these requirements.

As explained more fully below, we conclude that substantial evidence in the record supports the ALJ's conclusion that Willow Creek was in substantial compliance with the two participation requirements at issue. Contrary to what CMS argues, the ALJ did [Page 2] not base her decision solely "on the success of the facility [in] preventing a full blown elopement." CMS Reply Br. at 6. Instead, the ALJ specifically found, based on substantial evidence in the record, that Willow Creek had planned and implemented effective interventions to address the elopement risk and that R4 was well-supervised. In reaching her conclusion that Willow Creek provided adequate supervision to prevent accidents, as required by section 483.25(h)(2), the ALJ did rely heavily on inferences she drew from the fact that R4's exits from the building were not undetected or unsupervised. However, the inferences themselves were not unreasonable, and the ALJ also cited testimony in sworn declarations regarding other interventions and staff training that she found credible. Since substantial evidence supports the ALJ's findings that Willow Creek was providing adequate supervision, it is immaterial for purposes of this review whether Willow Creek could have implemented additional interventions to increase its supervision of R4.

Accordingly, we affirm the ALJ's conclusion that Willow Creek was in substantial compliance with section 483.25(h)(2). Since CMS does not dispute the ALJ's treatment of CMS's finding of a deficiency under section 483.75 as wholly derivative of its finding of a deficiency under section 483.25(h)(2), we also affirm the ALJ's conclusion that Willow Creek was in substantial compliance with section 483.75.

Legal Background

SNFs participating in the Medicare program are subject to survey and enforcement procedures set out in 42 C.F.R. Part 488, subpart E, to determine if they are in substantial compliance with applicable program requirements which appear at 42 C.F.R. Part 483, subpart B. "Substantial compliance" means a level of compliance such that "any identified deficiencies pose no greater risk to resident health or safety than the potential for causing minimal harm." 42 C.F.R. § 488.301. "Noncompliance," in turn, is defined as "any deficiency that causes a facility to not be in substantial compliance." 42 C.F.R. § 488.301.

The principal program requirement at issue here, section 483.25(h)(2), provides that "[t]he facility must ensure that . . . [e]ach resident receives adequate supervision and assistance devices to prevent accidents." This is part of the "quality of care" provision, which requires a facility to ensure that each resident receives "the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the comprehensive [Page 3] assessment and plan of care." Also at issue is the general requirement in section 483.75 that "[a] facility must 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 psycho-social well-being of each resident."

Case Background ⁽¹⁾

Willow Creek is a skilled nursing facility in South Carolina that participates in the Medicare program. Federal surveyors conducted a survey at Willow Creek from May 24 through 27, 2004. The survey report, called a Statement of Deficiencies (SOD), stated that Willow Creek "failed to ensure a system was in place to prevent a resident, admitted with a recent history of wandering and elopement, from leaving the facility four times within a span of 18 days during the month of May, 2004" and that this placed "residents who may attempt to elope at risk for serious injury, harm, impairment, and/or death." CMS Ex. 1, at 12. The four days in question were May 7, 18, 20, and 25. The SOD also stated that nurses' notes indicated that this resident had attempted to exit the building on April 25, May 1 and May 7 (less than two hours before the cited exit on May 7). Id. at 15-16. The resident in question, R4, was a 91-year-old male who was admitted to Willow Creek on March 12, 2004 with diagnoses that included Alzheimer's disease. Willow Creek assessed R4 as a wanderer at risk for elopement as well as at high risk for falls. Staff developed a written plan of care to address his wandering behavior. R4's plan of care lists 15 interventions designed to achieve the plan's goal, including instructions on how to interact with R4, "check and monitor resident's whereabouts frequently," "be alert for alarms on facility doors," "apply Wanderguard as ordered," and "work with activities in finding suitable diversional activities." ⁽²⁾ ALJ Decision at 5-6; P. Ex. 1, at 119.

[Page 4] Based on the survey findings, CMS determined that Willow Creek was not in substantial compliance with sections 483.25(h)(2) and 483.75 and that this noncompliance posed immediate jeopardy beginning May 7. The surveyors found that the immediate jeopardy was abated on May 25, 2004, when Willow Creek's administrator provided a plan of correction outlining a new protocol and interventions for residents at risk for elopement. (Willow Creek also modified its plan of care for the resident in question on May 25.) CMS also determined that Willow Creek was not in substantial compliance with 11 other participation requirements at the non-immediate jeopardy level, but that Willow Creek achieved substantial compliance on June 11, 2004. CMS imposed a CMP of $3,050 per day from May 7 through 24 and a CMP of $200 per day from May 25 through June 10. Willow Creek did not dispute the non-immediate jeopardy-level findings and thus was noncompliant for the entire period even if, as the ALJ found, Willow Creek had no immediate jeopardy-level deficiencies. The ALJ stated that Willow Creek was subject to the $200 per day CMP for the period May 25 through June 10 based on the undisputed non-immediate jeopardy-level deficiencies, and Willow Creek does not dispute that conclusion on appeal. ⁽³⁾

Willow Creek requested a hearing as to the two immediate jeopardy-level deficiencies. The parties agreed that this case could be decided based on their written submissions, without an in-person hearing.

[Page 5] The ALJ made the following lettered Findings of Fact and Conclusions of Law (FFCLs):

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).

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.

ALJ Decision at 5, 9. CMS excepts to both FFCLs.

The ALJ found that, contrary to what the surveyors found-

any reasonable review of the evidence establishes [that] 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.

ALJ Decision at 6. The ALJ proceeded to describe what happened on each of the four dates in question, stating that "there seems to be little dispute as to the critical facts surrounding these incidents . . . ." Id. at 7. The ALJ then stated that "I do not see that any elopement or other accident occurred here" (id. at 8) and continued:

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 prevent 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).

[Page 6] ALJ Decision at 8. The ALJ further stated:

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. . . .

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).

ALJ Decision at 9. The ALJ stated that there was therefore no question as to whether conditions at the facility posed immediate jeopardy. Id. The ALJ also stated that since "CMS relies on the same facts underlying its claim that the facility did not comply with" section 483.25(h)(2) to support its claim that the facility did not comply with section 483.75, she "cannot sustain a finding of substantial noncompliance with" section 483.75. Id. at 9-10.

Standard of Review

Our standard of review on a disputed finding of fact is whether the ALJ Decision is supported by substantial evidence on the record as a whole. Our standard of review on a disputed conclusion of law is whether the ALJ Decision is erroneous. Guidelines for Appellate Review of Decisions of Administrative Law Judges Affecting a Provider's Participation in the Medicare and Medicaid Programs, www.hhs.gov/dab/guidelines/prov.html; see also Lake Cook Terrace Nursing Center, DAB No. 1745 (2000); South Valley Health Care Center, DAB No. 1691 (1999), aff'd, South Valley Health Care Ctr. v. HCFA, 223 F.3d 1221 (10th Cir. 2000).

Substantial evidence is "more than a mere scintilla. It means such relevant evidence as a reasonable mind might accept as adequate to support a conclusion." Richardson v. Perales, 402 U.S. 389, 401 (1971), quoting Consolidated Edison Co. v. NLRB, 305 U.S. 197, 229 (1938). Under the substantial evidence standard, the reviewer must examine the record as a whole and take into account whatever in the record fairly detracts from the weight of the decision below. Universal Camera Corp. v. NLRB, 340 U.S. 474, 488 (1951). The reviewer does not, however, reweigh the evidence or substitute his or her judgment for that of the initial decision-maker. Casias v. Secretary of Health & Human Services, 933 F.2d 799, 800 (10^th Cir. 1991). Thus, the reviewer must not displace a "choice between two fairly conflicting views," even though a different choice could justifiably have been made if the matter had been before the reviewer de novo. Universal Camera, 340 U.S. at 488. The [Page 7] reviewer must, however, set aside the initial conclusions when the reviewer "cannot conscientiously find that the evidence supporting that decision is substantial, when viewed in the light that the record in its entirety furnishes, including the body of evidence opposed to the [initial decision-maker's] view." Id. In addition, the Board has held that an ALJ need not "cite to everything in the record which supports" the ALJ's findings, but that the "evidence that the ALJ does cite must support the findings made." Reconsideration of Wesley Hal Livingston and Shoals Medical Equipment and Supply Co., Inc., DAB No. 1406, at 3 (1993).

CMS maintains that the ALJ decided that Willow Creek was in substantial compliance with section 483.25(h)(2) based solely on a finding that Willow Creek's use of the Wanderguard alarm system prevented R4 from exiting the building unsupervised and undetected. According to CMS, this improperly suggests that "a resident could exit the facility [every day] and the facility would not be required to [do] anything in response as long as [it] prevented . . . an unsupervised, undetected exit." CMS Br. at 9. ⁽⁴⁾ CMS takes the position that the ALJ erred in failing to address evidence that Willow Creek did not implement the other interventions in R4's plan of care or evidence that the interventions in R4's plan of care did not constitute adequate supervision and should have been revised or supplemented. ⁽⁵⁾

[Page 8] As discussed below, however, while the ALJ did not discuss the other interventions as extensively as she discussed facility staff's implementation of the alarm system, she did not focus solely on the latter in concluding that substantial evidence supported a conclusion that Willow Creek adequately supervised R4. She did discuss other interventions designed to prevent R4 from exiting the building and determined that Willow Creek's witnesses testified credibly (in declarations) that these interventions were implemented by staff. This is sufficient to uphold the ALJ Decision since CMS does not dispute that staff responded promptly and appropriately to the alarm system each time R4 exited the building and returned him to the building unharmed or cite to any evidence directly contradicting the declarations.

Whether Willow Creek supervised R4 in accordance with his plan of care

A facility's duty to provide adequate supervision to prevent accidents under section 483.25(h)(2) must be read in the context of the lead-in language in the quality of care regulations. This language requires, in part, that a facility ensure that each resident receives care and services "in accordance with the comprehensive assessment and plan of care." The Board has pointed out this language in upholding deficiency findings where a facility failed to follow steps in a plan of care that were directed at preventing accidents. Coquina Center, DAB No. 1860, at 21 (2002).

[Page 9] CMS asserts that Willow Creek failed to implement the intervention in its plan of care for R4 requiring that nursing staff "check and monitor resident's whereabouts frequently." ⁽⁶⁾ According to CMS, the ALJ erred in concluding that Willow Creek was in substantial compliance with section 483.25(h)(2) without considering this issue. As discussed below, however, the ALJ found that Willow Creek implemented this intervention and her finding is supported by substantial evidence in the record.

The ALJ found that "staff implemented the interventions listed in R4's care plan[.]" ALJ Decision at 6. The ALJ also stated specifically that she found "fully credible Petitioner's assertions that . . . R4 was closely monitored[.]" Id. at 8. Thus, the ALJ found in effect that R4 was monitored in accordance with the requirement in his plan of care that nursing staff "check and monitor resident's whereabouts frequently." In part, the ALJ inferred that this was the case based on facility staff's "immediate and appropriate responses to the sound of the alarm going off, and their consistent successes in preventing R4 from eloping." Id. It is undisputed that in each of the four incidents cited in the SOD, facility staff responded immediately and appropriately to the alarm triggered by R4's Wanderguard bracelet and prevented R4 from leaving the building undetected or unsupervised. ⁽⁷⁾ If staff were not monitoring R4 in accordance [Page 10] with his plan of care, they might have ignored the alarm or not responded to the alarm as quickly. Thus, the ALJ reasonably inferred from staff's responses to the alarms that they were monitoring R4 in accordance with his plan of care.

The declarations cited by the ALJ provide additional support for her finding that staff monitored R4 in accordance with his plan of care. The declaration of Willow Creek's Administrator states that "facility staff had a sense of heightened awareness whereby it sought to ascertain [R4's] whereabouts . . . ." P. Ex. 8 (Declaration of Gayle Shelton), ¶ 5. The declaration of an LPN who worked at Willow Creek states that "I and other staff members were aware of Resident No. 4's desire to go home and I always kept a very close eye on him." P. Ex. 9 (Declaration of Dana Wiley), ¶ 10. The declaration of a CNA employed by Willow Creek states that "Generally, as part of our monitoring program, I attempted to check on Resident No. 4 every half-hour." P. Ex. 10 (Declaration of Melanie Evans), ¶ 3. These statements indicate that facility staff were aware of the need to monitor R4's whereabouts frequently. In addition, the latter two statements indicate that staff actually did so.

The ALJ also found that facility staff were "appropriately trained." ALJ Decision at 8. The declaration of Willow Creek's Director of Nursing (DON) supports this finding, stating that "[d]uring orientation, all facility employees are trained on elopement procedures," and that "[f]acility staff members have received training on the wander guard system and elopement prevention." P. Ex. 7 (Declaration of Kim Latham, R.N.), ¶¶ 7, 8. The declaration also states more specifically that "staff was instructed to maintain a heightened awareness of [R4's] whereabouts and to monitor him at frequent intervals." Id., ¶ 9. The unrebutted evidence that staff received training on monitoring lends credibility to their declarations asserting that they actually monitored R4 in accordance with his plan of care.

[Page 11] CMS nevertheless asserts that Willow Creek "did not have a system in place to effectively monitor Resident 4" (CMS Br. at 12), and points to evidence that the ALJ did not address when she found that R4 was "closely monitored." With respect to frequent monitoring of R4's whereabouts, CMS cites the statement in the SOD that the DON told surveyors that "no specific training has been provided to the staff on what this approach means." CMS Br. at 12, citing CMS Ex. 1, at 18. CMS interprets this as a reference to training on the monitoring intervention in R4's "original care plan." Id. However, the DON explained in her declaration below that she had been referring to the new monitoring program that was implemented during the survey (see P. Ex. 7, ¶ 11), and CMS points to no contrary evidence. The ALJ could reasonably have decided to give no weight to the statement in the SOD in light of this explanation, especially since she expressly found "fully credible Petitioner's assertions that staff were appropriately trained and that R4 was closely monitored . . . ." ALJ Decision at 8. In reviewing an ALJ decision, we do not reweigh the evidence, and we see no reason here not to accept the ALJ's evaluation of the credibility of the witness testimony.

CMS also notes that, according to Surveyor Holloway, the DON "told the surveyors that the facility did not document its monitoring of Resident 4." CMS Br. at 12, citing CMS Ex. 43, ¶ 23. However, there is nothing in the plan of care that suggests that such documentation was required, and CMS points to no other basis for requiring such documentation. While such documentation might have been helpful, it does not necessarily follow from the lack of documentation that Willow Creek was not actually monitoring R4 in accordance with his plan of care.

CMS also points out that in interviews with the surveyors, nursing staff provided different descriptions of what it meant "to check and monitor Resident 4's whereabouts frequently." CMS Br. at 12, citing CMS Ex. 1, at 17. According to the SOD, one CNA stated that she would check on R4 during the three "incontinent rounds" on her shift and "in between these times, but at no particular times"; a second CNA stated that "[y]ou should probably check him every 30 minutes to one hour"; and an LPN stated that "[i]t means to find him every 30 minutes and record his location." (In addition, a fourth staff member responded that she did not know because she was new.) R4's plan of care does not specify how frequently R4's whereabouts are to be monitored, and CMS does not assert that the monitoring described by any of the staff interviewed could not reasonably be viewed as frequent monitoring. Thus, the fact that these staff did not have precisely the same understanding of how R4 should be [Page 12] monitored does not necessarily mean that R4 was not actually monitored in accordance with his plan of care. Neither is there evidence that the lack of a specific monitoring schedule in the plan of care or staff's inability to consistently articulate what frequent monitoring meant resulted in an undetected exit from the building or threatened harm to R4, such as from a fall. Thus, this case is not like other cases where we have found a failure to provide adequate supervision based on the type of evidence CMS cites. See, e.g., Golden Age Skilled Nursing & Rehabilitation Center, DAB No. 2026 (2006) (facility not aware of resident's location for 10 to 15 minutes before the resident was found on a sidewalk two blocks north of the facility); Aase Haugen Homes, Inc., DAB No. 2013 (2006) (facility not aware of residents' absence from the facility until notified by neighbors that one resident was walking by a dike 180 feet from the facility and other resident was across the street from the facility, even though in the latter incident an alarm had sounded).

Accordingly, we conclude that substantial evidence in the record supports the ALJ's conclusion that Willow Creek supervised R4 in accordance with his plan of care.

Whether the supervision provided by Willow Creek was adequate to mitigate the foreseeable risk of harm to R4

The mere fact that a facility has followed its plan of care does not necessarily mean that it has provided adequate supervision. The lead-in language in the quality of care regulations requires a facility to provide care and services necessary for residents to attain or maintain "the highest practicable . . . physical or mental well being." 42 C.F.R. § 483.25 (emphasis added). Based in part on this language, the Board concluded in Woodstock Care Center, DAB No. 1726 (2000), aff'd, Woodstock Care Ctr. v. Thompson, 363 F.3d 583 (6^th Cir. 2003), that "while the regulations do not make facilities unconditional guarantors of favorable outcomes, the quality of care provisions do impose an affirmative duty to provide services ... designed to achieve those outcomes to the highest practicable degree." DAB No. 1726, at 25. The Sixth Circuit upheld the Board and specifically rejected Woodstock's argument that common law standards of reasonable care governed. The court stated that "[t]he regulations can and do set a higher standard than the common law" and that a facility must take "all reasonable precautions against residents' accidents." 363 F.3d at 589-590. Thus, "[a]lthough section 483.25(h)(2) does not make a facility strictly liable for accidents that occur, it does require the facility to take all reasonable steps to ensure that a resident receives supervision and assistance devices that meet his or her assessed needs and [Page 13] mitigate foreseeable risks of harm from accidents." Golden Age at 11 (citing 363 F.3d at 590). "A facility is permitted the flexibility to choose the methods of supervision it uses to prevent accidents, but the chosen methods must be adequate under the circumstances." Id. "Whether supervision is 'adequate' depends, of course, on the resident's ability to protect himself or herself from harm." Id.

The ALJ found that the interventions implemented by R4 "effectively protected R4 from harm." ALJ Decision at 6. The ALJ inferred that this was the case based on her finding that "R4 never departed the building undetected or unsupervised[.]" Id.

CMS argues that this inference is unreasonable since, in its view, the fact that R4 exited the building at all shows that Willow Creek was not providing supervision adequate to mitigate the foreseeable risk that R4 would sustain an accident relating to elopement. ⁽⁸⁾ CMS argues specifically that-

[e]ven if a resident is in sight of facility staff members [that] does not mean the resident is supervised and safe from accident hazards present immediately outside the facility. A resident could sustain a fall before being reached by staff. With every successive exit the facility risked the chance that the resident would eventually elope unsupervised, such as when staff was unable to respond in time. Therefore, there was a likelihood a resident would sustain harm if they are continually allowed to exit the facility.

CMS Br. at 11. In support of its argument, CMS relies on several statements in the declaration of Surveyor Holloway that were not addressed by the ALJ, including her statement that R4 could have been harmed "if the alarm systems failed or the batteries in his wanderguard bracelet were not working" or if he had "eloped in the middle of the night when staff would be limited and may not respond as quickly to the alarm" and her statement that R4 "could have fallen on the sidewalk or on the sloped grassy terrain" immediately outside the exit doors, or "could have eloped into the road or fallen into the drainage ditch." CMS Br. at 18, citing CMS Ex. 43, ¶¶ 32, 35. CMS also relies on Surveyor Holloway's statement that "[c]ognitively impaired residents who have a history of wandering and eloping are at risk for accidents," pointing out that R4 had such a history and was identified by staff as oblivious to safety. CMS Reply Br. at 8, citing CMS Ex. 43, ¶ 5; CMS Ex. 12, at 46-50. In addition, CMS points out that R4 was determined to be at high risk for falls in his March 12, 2004 Falls Risk Assessment and contends that "[b]eing outside the facility on unfamiliar ground would have increased the risk that the resident could have sustained an accidental fall . . . ." CMS Br. at 18, citing P. Ex. 1, at 93. ⁽⁹⁾

Under the substantial evidence standard, the Board is required take into account whatever in the record fairly detracts from the weight of the decision below. See Universal Camera, 340 U.S. at 488. We have considered the evidence cited by CMS under that standard and conclude that the evidence does not fairly detract from the weight of the ALJ's decision (although it might have been preferable for the ALJ to address it directly). The ALJ found, and CMS does not dispute, that Willow Creek regularly checked the Wanderguard alarm system and that the alarm sounded in each of the four incidents on which the surveyors relied. See ALJ Decision at 8. Thus, Willow Creek was taking steps to mitigate the risk that R4 would exit without the alarm sounding. In addition, R4's four exits and his three attempted exits all occurred in the afternoon, not at night, which undercuts Surveyor Holloway's premise of a greater risk at night. See CMS Ex. 1, at 14-16; CMS Reply Br. at 19.

[Page 15] Moreover, when R4 exited the building, the farthest he went before staff intercepted him was the sidewalk (on May 18) and the edge of the grass closest to the building (on May 7). See id. Since the staff successfully intervened before R4 encountered the safety hazards identified by Surveyor Holloway, the ALJ could reasonably determine that Willow Creek's supervision was adequate, despite the fact that R4 may have been oblivious to safety due to his cognitive deficits. ⁽¹⁰⁾ In summary, much of Surveyor Holloway's testimony about the risk of harm to R4 amounts to unsupported speculation based on premises-failure of the Wanderguard alarm system, staff inattention, the lack of other interventions-for which there is simply no support in the record. Thus, we cannot say that the ALJ erred in not directly addressing this testimony. Finally, although R4 was assessed as at high risk for falls, there is no indication in the record that he fell at any time before or after his admission to Willow Creek. (In contrast, in Golden Age, the resident who left the facility undetected had a history of falls and needed to use a walker to ambulate.)

Accordingly, we conclude that substantial evidence in the record as a whole supports the ALJ's finding that the supervision provided by Willow Creek in accordance with R4's plan of care was adequate to meet R4's assessed needs and to mitigate the foreseeable risk of harm to R4. It is therefore immaterial for purposes of this review whether Willow Creek could have implemented additional interventions to increase its supervision of R4.

Conclusion

For the reasons discussed above, we affirm all the ALJ's findings of fact and conclusions of law.

Judith A. Ballard

Donald F. Garrett

Sheila Ann Hegy
Presiding Board Member

1. The facts included in this background are drawn from the ALJ Decision and the record before the ALJ. They are not intended to substitute for the ALJ's findings.

2. According to the ALJ, the "Wander Guard system" consists of a bracelet transmitter attached to the resident's wrist or ankle which sets off a door alarm if the resident attempts to exit the facility. See ALJ Decision at 5, n.4. Neither party challenges this description.

3. The ALJ did not address what would be a reasonable amount of CMP for the undisputed non-immediate jeopardy- level deficiencies during the period May 7 through 24. She merely noted that CMS had not specified the exact amount of CMP for those deficiencies during that period. Nevertheless, Willow Creek has not raised before us any question about the amount of that CMP. Accordingly, for purposes of this appeal, CMS would be justified in setting the CMP for the May 7 through 24 period at any reasonable amount, but no more than the $200 per day it imposed for the May 25 through June 10 period of undisputed continuing noncompliance.

4. While the declarations of CMS witnesses refer to the exits as "elopements," CMS, as the ALJ noted, defined an elopement as occurring "when a resident, who is cognitively impaired or not capable of protecting himself from harm, exits the facility unsupervised without staff knowledge." ALJ Decision at 6, citing CMS Final Br. at 9, n.2. CMS does not argue in its appeal brief that the exits in question here met that definition but argues instead that "[t]he fact that the resident may or may not have eloped is immaterial . . . ." CMS Br. at 10.

5. CMS also suggests that Willow Creek should have reassessed R4 in light of his exits. See CMS Br. at 8, 14. The regulations require a comprehensive reassessment within 14 days after a facility determines or should have determined that there has been a "significant change in the resident's physical or mental condition." 42 C.F.R. § 483.20(b)(2)(ii). However, CMS does not cite this regulation. On the record here (where staff supervision prevented an elopement and no harm came to R4), the exits could reasonably be viewed as simply a continuation of R4's exit-seeking behavior that began in late April, behavior for which the facility had already assessed him and implemented interventions, rather than a "significant change." Moreover, the situation here is not analogous to those addressed by the preamble to the final rule amending section 483.20 to provide for a resident assessment instrument for use in comprehensive assessments. That preamble states that "standards of good clinical practice dictate that the assessment process . . . should be on-going" and that the facility "is also responsible for assessing and intervening in response to acute or emergent problems such as respiratory distress or fever." 62 Fed. Reg. 67174, 67193 (Dec. 23, 1997).

6. CMS also notes that R4's plan of care included as an intervention "finding [R4] diversionary activities," and asserts that Willow Creek "failed to involve the resident in diversionary activities," citing evidence that R4 rarely participated in group activities. CMS Br. at 12; CMS Reply Br. at 15. Although the activities progress notes observe that R4 "needs much encouragement to attend group activities," the record shows that Willow Creek made such activities available to R4. See P. Ex. 2; P. Ex. 1, at 239. The record also shows that R4 had numerous one-on-one visits with family, volunteers and staff. See P. Ex. 2.

7. CMS notes that one of the surveyors stated that the resident who lived in the room next to R4 told surveyors that during a fire drill on April 15, 2004, R4 left the building undetected after the fire doors between his room and the nurses station closed. CMS Br. at 13, citing CMS Ex. 43 (Declaration of Leontyne J. Holloway, M.A., R.N.), ¶ 22. (This was also reported in the SOD. CMS Ex. 1, at 18-19.) Willow Creek does not dispute this, and the ALJ did not address it. However, the surveyors did not take this incident into account in finding that Willow Creek "failed to ensure a system was in place to prevent [R4] . . . from leaving the facility . . . ." CMS Ex. 1, at 12. Moreover, this incident occurred before the period of noncompliance and occurred in circumstances distinguishable from the four exits that occurred during the period of noncompliance and which CMS did take into account. Accordingly, we cannot say that the ALJ had a clear duty to address this incident and, thus, cannot say that she erred in not doing so.

8. CMS suggests that, in finding that Willow Creek "effectively protected R4 from harm," the ALJ meant only that R4 "did not sustain actual harm." CMS Br. at 20. As CMS correctly notes, the "core issue" where a deficiency under section 483.25(h)(2) is alleged is not whether accidents occurred, "nor whether they resulted in injuries, but whether the quality of the supervision at [the facility] was such that residents were subject to the risk of injury from accidental causes in their daily activities." See Woodstock Care Center, DAB No. 1726, at 35. However, it appears in context that the ALJ was taking into consideration the foreseeable risk of injury from accidental causes, not just the absence of actual harm.

9. CMS cites most of this evidence in its discussion of whether the alleged noncompliance posed immediate jeopardy. However, it is also relevant to whether there was a potential for more than minimal harm.

10. It is also possible that Surveyor Holloway's assessment of the risk of harm to R4 was affected by the fact that she seemed to view his exits as "elopements" even though they were not elopements under her own definition of that term.