2006.04.20 DAB2026 Golden Age Skilled Nursing & Rehabilitation Center vs. Centers for Medicare & Medicaid Services (2022)

FINAL DECISION ON REVIEW OF
ADMINISTRATIVE LAW JUDGE D
ECISION

On June 17, 2005, Golden Age Skilled Nursing & Rehabilitation Center (Golden Age), an Iowa skilled nursing facility (SNF), appealed the decision of Administrative Law Judge (ALJ) Keith W. Sickendick that upheld a $3,100 civil money penalty (CMP) imposed by the Centers for Medicare & Medicaid Services (CMS). Golden Age Skilled Nursing & Rehabilitation Center, DAB CR1326 (2005) (ALJ Decision). CMS imposed the CMP based on its determination that Golden Age had inadequately supervised a resident -- Resident 1 -- who, on August 12, 2002, walked away from the facility unescorted.

After receiving documentary evidence from the parties, the ALJ concluded that Golden Age had failed to provide adequate supervision to Resident 1 in violation of 42 C.F.R. § 483.25(h)(2). The ALJ also determined that CMS's finding that Golden Age's noncompliance placed Resident 1 in immediate jeopardy was not clearly erroneous. In addition, the ALJ found that the amount of the CMP was reasonable given the seriousness of the deficiency and other circumstances.

[Page 2] Golden Age now contends that: (1) the ALJ abused his discretion in failing to admit into evidence a videotape of Resident 1; (2) substantial evidence is lacking for the ALJ's conclusion that Resident 1 received inadequate supervision; and (3) the ALJ erred in upholding CMS's immediate jeopardy finding.

We find no merit in these contentions. In addition, we deny Golden Age's request that we evaluate three deficiency citations that did not result in an enforcement remedy. Finally, we find no basis to disturb the ALJ's finding that the amount of the CMP was reasonable. For these reasons, we affirm the ALJ Decision in its entirety.

Regulatory background

To participate in the Medicare program, a SNF must comply with the requirements for participation found in 42 C.F.R. Part 483, subpart B. Compliance with those requirements is verified by periodic surveys performed by state health agencies on CMS's behalf. See 42 C.F.R. Part 488, subpart E. The state agency reports its findings in a Statement of Deficiencies. The Statement of Deficiencies identifies each "deficiency" -- or failure to meet a participation requirement -- with an alpha-numeric "tag" that corresponds to the relevant participation requirement in Part 483 of the regulations.

As part of a survey, the state agency rates the scope and severity of noncompliance for each deficiency by assessing, among other things, the degree of harm (or potential for harm) resulting from the noncompliance. 42 C.F.R. § 488.404. The highest scope and severity ratings are those at the "immediate jeopardy" level.

CMS may impose one or more enforcement remedies, such as a civil money penalty (CMP), on a SNF that is not in "substantial compliance" with federal participation requirements. 42 C.F.R. § 488.402(b), (c). A SNF is not in substantial compliance when it has one or more deficiencies that create at least the "potential for more than minimal harm" to residents. 42 C.F.R. § 488.301. The regulatory term "noncompliance" means "any deficiency that causes a facility to not be in substantial compliance." Id.

A CMP may be imposed either for the number of days the SNF is not in substantial compliance (a per-day CMP), or "for each instance that [the] facility is not in substantial compliance" (a per-instance CMP). 42 C.F.R. § 488.430(a). For any "instance" of [Page 3] noncompliance, the regulations authorize a CMP in the range of $1,000 to $10,000. 42 C.F.R. § 488.438(a)(2).

A SNF is entitled to an ALJ hearing to contest a finding of noncompliance that resulted in the imposition of an enforcement remedy. 42 C.F.R. § 488.408(g)(1).

Case Background (1)

On August 23, 2002, the Iowa Department of Inspections and Appeals (IDIA) completed a survey of Golden Age. CMS Ex. 3, at 1. Surveyors learned that on August 12, 2002, Resident 1 walked away from the facility's grounds without escort. Id. at 3. Based on this incident, IDIA cited Golden Age under tag F324 for noncompliance with 42 C.F.R. § 483.25(h)(2), which requires a SNF to ensure that each resident receives "adequate supervision and assistance devices to prevent accidents." Id. at 1-9 (emphasis added). IDIA also found that this deficiency had created a situation of immediate jeopardy. Id. at 1.

In addition to finding a violation of section 483.25(h)(2), IDIA cited Golden Age for deficiencies under tags F492, F496, and F497. CMS Ex. 3, at 9-12. These citations alleged violations of various administrative requirements in 42 C.F.R. § 483.75 and are unrelated to the August 12th incident involving Resident 1.

On September 9, 2002, CMS notified Golden Age that it was imposing a per instance CMP of $3,100 based on the deficiency finding under tag F324. CMS Ex. 1.

Golden Age appealed CMS's enforcement action by requesting an ALJ hearing. Golden Age later waived its right to an in-person evidentiary hearing, and both parties agreed to have the ALJ decide the case based on the pleadings, documentary evidence, and briefs. The parties also provided the ALJ with Joint Stipulations of Fact (Jt. Stip.) concerning Resident 1 and the events of August 12.

Although Golden Age presented the ALJ with argument on all four alleged deficiencies identified by the August 2002 survey, the ALJ Decision addresses only tag F324, which was the only [Page 4] deficiency for which CMS imposed a remedy. The decision begins with some evidentiary rulings, one of which was a denial of Golden Age's request to admit a videotape of Resident 1. ALJ Decision at 2-3.

The ALJ Decision then sets out 19 numbered findings of fact regarding tag F324, including the following:

6. Resident 1 was admitted to Petitioner's facility on January 9, 2001.

7. Resident 1 suffered from an anxiety disorder, high blood pressure, diabetes, tremors, poor vision, and atrial fibrillation and she had to use a walker.

8. Resident 1's care plan, dated March 13, 2002, recognized a history of falls and specified that she wear non-skid, well-fitting footwear, that her environment be kept safe with clear pathways, and required that her walker be within reach at all times.

9. Resident 1 was coherent, alert, and oriented except for a few instances.

10. Resident 1 was required to wear a WanderGuard™ bracelet, a transponder bracelet that triggered a door alarm when the resident approached a door with the alarm system.

11. Petitioner allowed Resident 1 to sit outside the facility, as she desired, at picnic tables at the front of the facility and Resident 1 had done so numerous times in the past with no apparent difficulty.

12. Staff knew when Resident 1 exited and entered the building because she triggered the door alarm, causing a staff member to check who triggered the alarm and to reset it.

13. Petitioner had no written plan for supervising or checking on Resident 1 while she was outside but Petitioner asserted that staff knew to check her intermittently.

[Page 5] 14. On August 12, 2002, a staff member [Golden Age's activity director] saw Resident 1 sitting outside the facility at the picnic tables with another resident who was also her roommate, but 10 to 15 minutes later the same staff member noted that Resident 1 was missing.

15. Resident 1 was found, unharmed, two blocks north of the facility on the sidewalk on the same side of the street as the facility.

16. Petitioner was not aware of Resident 1's departure or her location for a period of 10 to 15 minutes and had effectively lost all control and supervision over the resident until she was located and placed in a staff member's car.

17. Examples of foreseeable hazards for Resident 1 or a similar resident when outside Petitioner's building include the parking lot with approaching and backing cars and a potentially slippery surface given oil and water leaks; the low planter and low parking lot curb upon which a walker leg might catch; wet grass; uneven grass and dirt surfaces; the blunt ends of the horizontal surfaces of the picnic table and the table legs; and a street with traffic approximately 156 feet from the front of the building.

18. Petitioner produced no evidence to show that a plan to supervise Resident 1, while she was outside, was actually formulated and implemented or that staff was aware of such a plan.

19. No staff members were identified by Petitioner as having the responsibility for checking on Resident 1 the day of the incident and no staff has provided evidence that they did, in fact, check on Resident 1.

ALJ Decision at 3-5. The ALJ later indicated that when Resident 1 left the facility's grounds on August 12, 2002, she was using her walker and intended to walk to her sister's house. Id. at 9. The ALJ also found it undisputed that a "neighbor of the facility observed that Resident 1 attempted to cross the street but was apparently deterred by traffic and continued walking along the same side of the street as the facility, first on the grass then on the sidewalk." Id. In addition, the ALJ took note of the [Page 6] parties' agreement that Golden Age had "no established procedure for checking on Resident 1 when she sat outside except that staff did check 'off and on.'" Id. (citing Jt. Stip. at 3-4).

Based on the foregoing findings, the ALJ made the following numbered conclusions of law:

    2. There is prima facie evidence that Petitioner violated 42 C.F.R. § 483.25(h)(2).

    3. The narrow issue is whether or not Petitioner's supervision, as described by Petitioner in this case, was "adequate."

    4. Petitioner did not provide adequate supervision to Resident 1 to prevent accidents, considering Resident 1's condition and the foreseeable hazards.

    5. Resident 1 was unsupervised and left the facility grounds, exposing herself to the hazards of vehicle traffic, weather, uneven terrain, and similar hazards that present great risk of harm to one so impaired.

    6. The declaration of immediate jeopardy was not clearly erroneous.

    7. A per instance CMP of $3,100.00 is reasonable.

ALJ Decision at 5.

In discussing these conclusions, the ALJ rejected Golden Age's contention that there was no foreseeable risk of harm to Resident 1 while she was outdoors. ALJ Decision at 11-12. Based on photographs of the area surrounding the picnic tables where Resident 1 sat, the ALJ observed that it "would be necessary for the resident to take some steps upon what is clearly a grass and soil surface." Id. at 11. He also took note of other outdoor features, including raised curbs along the parking lot (which was adjacent to the picnic area) and a stone planter on the grass near the picnic tables. Id. The ALJ then stated:

Given the details I can glean from the photographs, Petitioner's assertion that there was "no foreseeable" risk to Resident 1 presented by her going to and sitting at the picnic tables is simply not credible. There is no dispute that Resident 1 had to use a walker [Page 7] and she had poor vision. Resident 1 did not ambulate as an unimpaired person would. Thus, what might not pose a risk of harm for an unimpaired person would be a foreseeable hazard to her. Examples of foreseeable hazards for Resident 1 or a similar resident include the parking lot with approaching and backing cars and a potentially slippery surface given oil and water leaks; the low planter and low parking lot curb upon which a walker leg might catch; wet grass; uneven grass and dirt surfaces; the blunt ends of the horizontal surfaces of the picnic table and the table legs; and of course the street itself, which Resident 1 demonstrated could be reached by a person so impaired in a very brief period.

Id. at 11-12 (citations omitted).

The ALJ also found that the facility had "presented no evidence that includes care planning for Resident 1's history of falls and making the outdoors safe for her either by assistance devices or adequate supervision." ALJ Decision at 12. Although some staff members reported that they had checked Resident 1 "off and on" when she was outdoors (see Jt. Stip. ¶ 7(h)), the ALJ found no evidence that a plan for such intermittent monitoring had been formulated or implemented. Id. at 5 (finding of fact no. 18). (2) In addition, the ALJ found that Golden Age had not identified the staff members responsible for monitoring Resident 1 on August 12, 2002. Id. (finding of fact no. 19). Finally, the ALJ found no evidence that staff had actually checked on Resident 1 while she was outside on August 12, noting that it was merely "fortuitous" that her absence was discovered by the facility's activity director. Id. at 5 (finding of fact no. 19), 12.

Standard of Review

In general, we review an ALJ decision to determine if the ALJ's findings of fact are supported by substantial evidence and its conclusions of law are correct. Guidelines - Appellate Review of Decisions of Administrative Law Judges Affecting a Provider's Participation in the Medicare and Medicaid Programs (at http://www.hhs.gov/dab/guidelines/prov.html); South Valley Health Care Center, DAB No. 1691, at 2 (1999), aff'd, South Valley Health Care Center v. HCFA, 223 F.3d 1221 (10th Cir. 2000).

[Page 8] Substantial evidence is such "relevant evidence as a reasonable mind might accept as adequate to support a conclusion." Community Skilled Nursing Centre, DAB No. 1987 (2005) (citing and quoting cases). 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. Id. The reviewer does not, however, reweigh the evidence or substitute his or her judgment for that of the initial decision-maker. Id. 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. Id. The reviewer must, however, set aside the initial conclusions when he or she "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. An ALJ need not cite all the evidence supporting his findings, but the evidence he does cite must support the findings made. Id.

Golden Age's contentions on appeal (3)

Golden Age first contends that the ALJ "abused his discretion" in failing to admit a videotape of Resident 1. Golden Age (GA) Brief (Br.) at 5-9. It contends that the videotape was the "best evidence" of Resident 1's visual acuity and mobility at the time of the survey. Reply Br. at 2.

Second, Golden Age contends that the record does not support the ALJ's conclusion that its care of Resident 1 violated section 483.25(h)(2). GA Br. at 5 (¶ 2), 9-17. It argues that the ALJ's [Page 9] finding that Resident 1 was at risk of injury from certain outdoor hazards (e.g., wet grass, uneven surfaces) was based on an erroneous assumption that she had poor vision and could not walk well. Id. at 9-13. Golden Age also asserts that the ALJ made an unsupported finding that it failed to supervise Resident 1 adequately when she was outdoors. Id. at 13-17.

Third, Golden Age contends that the ALJ erred in upholding CMS's immediate jeopardy finding. GA Br. at 17-22. According to Golden Age, this finding was clearly erroneous because the "totality of the circumstances" showed that "Resident 1 was not in a situation that was likely to cause her serious injury, harm, impairment or death." Id. at 19.

Fourth, Golden Age asks the Board to make findings regarding the deficiencies cited under tags F492, F496, and F497. GA Br. at 22-30. Golden Age asserts that these alleged deficiencies, if not challenged, "could be the basis for an episodic civil money penalty, even if the F-324 tag is eliminated[.]" Id. at 22.

Finally, Golden Age asks that we reduce the amount of the CMP in the event that we vacate or reverse CMS's immediate jeopardy finding or any of the three deficiencies cited under tags F492, F496, and F497. GA Br. at 21-22.

We address each of these contentions or requests below.

Discussion

1. The ALJ did not abuse his discretion in excluding from the record the videotape of Resident 1.

In a written "proffer" filed before the parties waived their opportunity for an in-person hearing, Golden Age asked the ALJ to admit a videotape of Resident 1 along with a transcript of its audio content. The videotape was made on August 23, 2002, 11 days after Resident 1's elopement. Golden Age stated in its proffer that the videotape showed a staff member administering a mini-mental status examination (MMSE) to Resident 1 as well as Resident 1 answering questions about her elopement. Golden Age also stated that it was offering the videotape to show Resident 1's "mental status" and "thought processes," and that witnesses would testify that Resident 1's mental abilities as shown on the videotape were the same as the ones she possessed or exhibited on August 12, 2002. See GA's Proffer of Evidence (Jan. 9, 2003); GA's Amended Proffer of Evidence (Jan. 15, 2003).

[Page 10] The ALJ decided to admit the transcript of the videotape, but not the videotape itself, indicating that he had compared them and found the videotape to be "merely cumulative," having no "additional evidentiary value over that of the transcript[.]" ALJ Decision at 2. Golden Age now contends that the videotape should have been admitted not because it was non-cumulative evidence of Resident 1's mental status and thought processes, but because it was the "best evidence" of her visual acuity and agility with a walker. See Reply Br. at 1-2. Golden Age asserts that the videotape "demonstrated that the resident (even without her glasses) was able to see several documents presented to her[.]" GA Br. at 6. According to Golden Age, the videotape also showed her standing up from a chair, grabbing her walker, walking to a door, stepping out into a hallway (where she paused to let someone pass), and ambulating down the hall "at a quick and steady pace." Id. at 10. Golden Age never mentioned or described these activities in its proffer, however. Nor did it tell the ALJ that it considered the videotape to be probative evidence of Resident 1's visual acuity or mobility. Under the circumstances, we cannot find that the ALJ abused his discretion in failing to admit evidence for a purpose that was never disclosed to him.

In any event, the videotape would have negligible, if any, evidentiary value. Golden Age contends that the videotape was the "best evidence" of Resident 1's "visual acuity" and "agility with her walker," two elements of her functional capacity that "seemed to be the focus of the ALJ's concern." GA Br. at 6, 8. However, the best evidence of a resident's mobility and visual acuity is not a snapshot-in-time videotape (especially when it was made 11 days after the incident at issue), but medical records -- including the plan of care, nursing notes, and results of comprehensive assessments -- that are generated in the routine or normal course of providing care and treatment to residents. Moreover, even assuming that the videotape was competent evidence of Resident 1's ability to move safely inside the facility, that would say little, if anything, about her ability to remain safe from harm outside the facility.

For the reasons above, we uphold the ALJ's ruling with respect to the August 23, 2002 videotape of Resident 1.

2. The ALJ's conclusion that Resident 12 received supervision inadequate to prevent accidents is supported by substantial evidence.

The ALJ concluded that Golden Age's care of Resident 1 on August 12, 2002 did not comply with 42 C.F.R. § 483.25(h)(2). The [Page 11] requirements of this regulation have been explained in numerous Board decisions. Estes Nursing Facility Civic Center, DAB No. 2000 (2005); Northeastern Ohio Alzheimer's Research Center, DAB No. 1935 (2004); Woodstock Care Center, DAB No. 1726, at 28 (2000), aff'd, Woodstock Care Center v. Thompson, 363 F.3d 583 (6th Cir. 2003). Although 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 mitigate foreseeable risks of harm from accidents. Woodstock Care Center v. Thompson, 363 F.3d at 590 (a SNF must take "all reasonable precautions against residents' accidents"). 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 determined that because of Resident 1's "poor vision" and need to use a walker, there was a foreseeable risk that she might fall while outdoors, especially if she attempted to navigate around or over obstacles or ambulate along grass, soil, or some other uneven surface. Golden Age contends that this finding is based on an "erroneous assumption that [Resident 1] could not walk well" and had poor or inadequate vision. GA Br. at 11, 13. Regarding her mobility, Golden Age points to Resident 1's March 2002 Minimum Data Set (MDS), which indicates that Resident 1 had not fallen in the past 180 days, did not have an unsteady gait or limited range of motion in her lower extremities, and was able to move independently both "on unit" (that is, between locations in her room and adjacent corridor) and "off unit" (that is, move to and from off unit locations set aside for dining, activities, or treatments). Id. at 10-11 (citing CMS Ex. 4, at 99-101). Golden Age also asserts that Resident 1's most recent fall occurred when she was ill, and that the excluded videotape shows that she could walk well with her walker. Id. at 10-11. As for Resident 1's vision, Golden Age asserts that it had no impact on her ability to perform "activities of daily living," and that she could identify objects and read newspaper print. Id. at 11-13.

We do not agree that the ALJ assumed that Resident 1 "could not walk well." He found only that Resident 1 "could not walk as an unimpaired person could," a finding that is supported by substantial evidence on the record as a whole. There is no dispute that Resident 1 had a history of falls and needed to use a walker whenever she ambulated. These facts, without more, support the ALJ's finding. Moreover, the evidence cited by [Page 12] Golden Age refers primarily to observations covering a limited period of time, such as the MDS statements that no unsteady gait was "present in the last 7 days" or that she had "not fallen in the last 180 days." GA Br. at 10-11 (citing CMS Ex. 4, at 100-101). However, Resident 1's plan of care reflected the facility's current (as of August 2002), ongoing assessment of her abilities, unless and until the care plan was changed. The plan of care states that Resident 1 had "unsteady gait at times[.]" CMS Ex. 4, at 68. This indicates that staff could not rely on her gait being steady at any given time, regardless of when her last episode of unsteady gait or a fall occurred. Furthermore, the MDS that Golden Age relies on also states that when tested for standing balance, Resident 1 was "[n]ot able to attempt [the] test without physical help." Id. at 100. Presumably Resident 1's impaired balance when standing would also impair her ability to ambulate.

Substantial evidence also supports the ALJ's finding that Resident 1 had poor vision. According to a "visual function" resident assessment protocol (RAP), Resident 1 had "[d]ecreased visual acuity," a problem that was caused or complicated by macular degeneration, diabetes, and a "CVA" (cerebrovascular or cardiovascular accident (4)). Golden Age's records indicate that her visual impairment did not affect her ability to perform "activities of daily living" and that she could "read newspaper headlines" and "some large print" and was "able to identify objects." Id. at 114. However, her MDS stated that she could not read regular print. Id. at 99. Facility records also indicate that her decreased visual acuity -- "near blindness" according to her plan of care -- was a factor in the facility's assessment of her being at risk of injury due to falls. Id. at 68. Moreover, a "psychosocial well-being" RAP states that she was "legally blind." Id. at 110.

Based on the evidence of record here, it is clear that while the visual impairment did not prevent Resident 1 from performing most daily activities, it did put her at increased risk of falling. In fact, her care plan describes her as "High Risk for Injury/Potential for Falls" based in part on "[d]ecreased visual acuity with near blindness[.]" CMS Ex. 4, at 69. If the facility no longer assessed Resident 1 as being at high risk due to her impaired vision, it should have changed her care plan to reflect its new assessment. Under the circumstances, CMS and the ALJ could reasonably infer from Resident 1's records, particularly her care plan and other records that showed her at [Page 13] risk for falls, that her visual impairment diminished or adversely affected her ability to function safely.

The critical issue, of course, was whether Resident 1 needed supervision once she was allowed outside the facility. The totality of the evidence supports the ALJ's finding that Resident 1 was at foreseeable risk of accidental harm while outdoors and therefore needed supervision in that environment. As discussed, Resident 1's plan of care and resident assessment protocol (RAP) summary indicate that she was at "high risk" for injury (even within the facility) and had a "potential for falls" due to various medical conditions, including diabetes, congestive heart failure, anxiety, degenerative arthritis, peripheral neuropathy, and "[d]ecreased visual acuity with near blindness." CMS Ex. 4 at 68, 108. Her gait was unsteady at times, and she needed to walk on dry and obstacle-free surfaces, according to her care plan. Id. at 68 (plan of care requirements for "non-skid" footwear and "clear pathways"). Staff members interviewed after the August 12, 2002 incident said that Resident 1 occasionally experienced periods of confusion. CMS Ex. 4, at 81, 82, 83, 85 ("sometimes she gets confused [about] small things"), 86 ("bouts of confusion"); see also Jt. Stip., ¶ 7(g). By requiring her to wear a WanderGuard bracelet, the nursing staff recognized the possibility that she might elope, an event that would cause her to wander beyond familiar confines onto uneven, unfamiliar, or slippery surfaces. (5) The ALJ's assumption that ambulating on such surfaces posed a special risk was not unfounded given that Resident 1 had told surveyors that ambulating on the grass with her walker was more difficult than doing so on a sidewalk. (6) CMS Ex. 3, at 3.

Although Golden Age suggests that Resident 1 would have been able to navigate the outdoor environment safely and without substantial risk, it produced no testimony or evidence of a [Page 14] nursing assessment to that effect. And although Resident 1 may have been able to perform most activities of daily living independently on a typical day, the nursing staff recognized the possibility of sudden changes in her level of functioning that might compromise her ability to keep herself safe. Her quarterly MDS form, completed in June 2002, indicates that her "[c]onditions/diseases make resident's cognitive, ADL, mood or behavior status unstable -- (fluctuating, precarious, or deteriorating)." CMS Ex. 4, at 61 (item J8). Given all these record facts, many of them from the facility's own records, we conclude that the ALJ's finding that there was a foreseeable risk of harm to Resident 1 when she was outdoors is supported by substantial evidence.

It is important to note here that Golden Age does not deny that Resident 1 required some supervision when she was outdoors. The thrust of its argument is that the risk of elopement or physical injury was low, and that the staff provided a level of supervision commensurate with the risk. Reply Br. at 5-6 (asserting that the supervisory measures were "tailored to this specific resident's unique strengths and the foreseeable risks to this resident"). That supervision involved use of the WanderGuard bracelet, which would trigger an alarm if Resident 1 went outside. Staff would verify that Resident 1 had triggered the alarm and was sitting at the picnic table in front of the building. In addition, says Golden Age, there was a "protocol" for checking on Resident 1 "off and on" while she was outside, a protocol that was, according to Golden Age, known to all the staff. Jt. Stip. ¶ 7(h); GA Br. at 16.

The ALJ found, in effect, that Resident 1 had received no supervision while she was outdoors on August 12, 2002. See ALJ Decision at 12 (noting that Golden Age had failed to identify persons responsible for monitoring Resident 1 on August 12 and had produced "no evidence that staff ever really checked on Resident 1 while she was sitting outside" that day). That finding is supported by the record. There was, as Golden Age concedes, no written plan, chart entry, or other notation verifying that there was a plan for supervising Resident 1 while she was outdoors. Prior to August 12, the facility "did not have a pre-established interval for checking on Resident #1 and Resident #2 when they went outside." Jt. Stip. ¶ 7(h). Although some members of the nursing staff told surveyors that there was a practice of checking Resident 1 intermittently ("off and on") when she was outside, see id., none of these employees claimed to have checked on Resident 1 while she was outside on August 12, and none claimed that they -- or others -- were responsible for [Page 15] doing so. It was, as the ALJ noted, merely fortuitous that her absence was discovered by Golden Age's activity director.

Golden Age asserts that all staff members knew about a "protocol" for periodic monitoring of Resident 1. GA Br. at 16. To support that assertion, Golden Age points to the statements of Mary Eloise Messamaker, a certified nurse assistant, and Raya Morrow, a licensed practical nurse. Id. (citing CMS Ex. 4, at 87, and GA Ex. 17, at 8). However, neither employee confirmed that the alleged protocol existed and was known to all staff. Morrow, for example, stated only that it "was common knowledge to shut the alarm off after [Resident 1] went outside to sit"; she did not indicate whether it was common knowledge that Resident 1 should be monitored while she was outdoors. CMS Ex. 4, at 87.

Golden Age also argues that it was unnecessary to have a written plan for monitoring Resident 1 because such monitoring constituted "routine services." GA Br. at 13-14. This argument is of little consequence because, as the ALJ found, there is no evidence that Resident 1 was actually supervised once she left the building on August 12, and because there is insufficient evidence of any commonly understood plan or procedure -- written or otherwise -- for monitoring her. A plan or protocol is an agreed-upon method or approach, one that assigns responsibility to specific employees for accomplishing a given task. Monitoring someone "off and on" is by its own terms an unstructured, ad hoc activity, not a plan. At minimum, a plan for monitoring a resident would specify the employees responsible for checking the resident and indicate how often that task should be performed. Golden Age admitted that there was no established monitoring interval for Resident 1 prior to August 12, 2002. Jt. Stip. ¶ 7(h). No employee indicated that he or she was responsible for checking Resident 1 at certain times, on certain days, or under certain circumstances. And there is no evidence that employees had a system or way to know when it was time to check on her.

Golden Age suggests that the survey findings effectively prevent it from meeting its obligation under the regulations to maintain and enhance Resident 1's quality of life. Reply Br. at 3-4, 6-7. It argues that, under CMS's view of the evidence, the only feasible alternative for supervising Resident 1 is "intrusive one-on-one supervision" or barring her from going outside at all. Either alternative would unnecessarily reduce her quality of life, says Golden Age.

We reject this argument because it presupposes that the ALJ determined what type or level of supervision Resident 1 required. He was not required to make such a determination, and he did not [Page 16] in fact do so. The ALJ simply found that Golden Age had failed to provide adequate supervision under the circumstances. More particularly, he found that Golden Age had failed to show that it had implemented a plan or procedure (written or otherwise) to supervise Resident 1 while she was outdoors. As discussed, that finding is supported by substantial evidence in the record. Resident 1 was assessed as needing a WanderGuard bracelet because of an elopement risk. This fact, even without more, means that the facility knew Resident 1 would not be safe outside the facility without supervision. That being the case, Golden Age was required to have a plan for such supervision, and to implement that plan. Moreover, since Golden Age did not even go through a process of developing plans or procedures, an endeavor that would have required Golden Age to consider its options for supervising Resident 1 while she was outdoors, it has no basis for asserting that there was no feasible alternative to one-on-one supervision or keeping her inside.

For the reasons above, we affirm the ALJ's conclusion that as of August 12, 2002, Golden Age was not in substantial compliance with 42 C.F.R. § 483.25(h)(2).

3. CMS's determination that Golden Age's noncompliance with 42 C.F.R. § 483.25(h)(2) created an immediate jeopardy situation is not clearly erroneous.

The ALJ concluded, based on all of the evidence, that CMS's finding of immediate jeopardy was not clearly erroneous. ALJ Decision at 12. We agree with - and affirm - that conclusion. (7)

[Page 17] Immediate jeopardy is defined as a "situation in which the provider's noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident." 42 C.F.R. § 488.301. CMS's determination concerning the level or seriousness of a facility's noncompliance must be upheld unless it is "clearly erroneous." 42 C.F.R. § 498.60(c)(2). The words "clearly erroneous" imply a deferential standard that places a heavy burden on the party seeking to overturn a finding or determination. Cf. Final Rule, Survey, Certification and Enforcement of Skilled Nursing Facilities and Nursing Facilities 59 Fed. Reg. 56,116, 56,179 (Nov. 10, 1994) (noting that the "provider's burden of upsetting survey findings relating to the level of noncompliance should be high," and that "[s]urvey team members and their supervisors ought to have some degree of flexibility, and deference, in applying their expertise in working with these less than perfectly precise concepts").

Golden Age contends that the evidence as a whole shows that, on August 12, 2002, Resident 1 was never in a situation likely to cause serious injury, harm, impairment, or death. Reiterating earlier points, Golden Age asserts that Resident 1 ambulated well without assistance, had not fallen recently, and did not have such poor vision that it affected her activities of daily living. In addition, says Golden Age, the evidence shows that Resident 1 was "alert and oriented" to person, place, and time on August 12, and that she could recall the details of her elopement. Golden Age also asserts Resident 1 was aware of accident hazards, noting that she chose not to continue crossing a busy street on August 12. In Golden Age's view, the outdoor hazards that the ALJ identified as posing a risk of harm were no more significant than the ones Resident 1 faced in the facility, such as "changes in floor surfaces, furniture, facility equipment, [and] residents in wheelchairs[.]" GA Br. at 19-20.

The definition of immediate jeopardy indicates that there must be some causal connection between the facility's noncompliance (here, the failure to adequately supervise Resident 1 when she was outdoors and to have plans and procedures for doing so) and the harm or likelihood of harm to residents. The definition also [Page 18] requires that the harm or likely harm (or injury or impairment) be serious. CMS could reasonably find, on the record before us, that these criteria were satisfied. As the ALJ noted (ALJ Decision at 13), by leaving the facility's grounds alone, Resident 1 became exposed to risks of harm from traffic, weather, and uneven terrain. It was 83 degrees Fahrenheit on the day of the incident, and Resident 1 reported that walking had made her hot and tired. Jt. Stip. ¶ 7(f); CMS Ex. 3, at 4. She had been spotted walking on the grass along the road, a surface that she said was more difficult to walk on than the sidewalk. CMS Ex. 3, at 3-5. Fatigue and a difficult walking surface could have impaired her stability with the walker, increasing the risk of a fall and resulting injury.

In addition, it is undisputed that there was traffic on the road she was walking beside when found. Her failed attempt to cross the street may in itself have posed special danger because there is no indication that it was done at a crosswalk or with aid of traffic signals. To the extent that she was relying on her own faculties to determine when it was safe to cross, it is unclear that these faculties were adequate. Golden Age presented no evidence ruling out the possibility that her visual impairment -- "near blindness," according to her plan of care, and legally blind according to a RAP -- affected her ability to spot and gauge the speed of approaching traffic.

The fact that Resident 1 might have been functioning well (at her baseline) that day does not mean that there was no threat or likelihood of harm. Although she appeared capable of functioning independently on many or most days, her physical and cognitive condition was found by the facility to be "unstable," and she was also found to be at "high risk" for injury because of the potential for falls. CMS Ex. 4, at 61 (item J8), 68. And although her periods of confusion may have been infrequent or "occasional," they were nevertheless unpredictable. Moreover, Resident 1's absence from the facility's property meant that any accident or other sudden deterioration in her medical status might not have been discovered quickly, delaying necessary medical attention.

Finally, Golden Age proffered no testimony that Resident 1 was able to walk along the road safely without substantial risk of harm. Nor did it establish that tighter or better supervision would not have prevented Resident 1 from straying on August 12. Moreover, CMS may reasonably consider not only the actual incident regarding a resident but what it reveals regarding the facility's planning procedures. Here, the facility records show awareness of the resident's status and her practice of going [Page 19] outdoors. Yet, the facility has not shown it had either any plan for her or any general supervisory protocol or even any staff designated to be responsible for her supervision when outside. Given all these circumstances, we conclude that CMS's finding that Golden Age's noncompliance was likely to cause serious injury or death was not clearly erroneous.

4. The ALJ did not err in failing to rule on the merits of tags F492, F496, and F497.

During the ALJ proceeding, the parties stipulated that the issues for hearing and decision were those associated with tag F324. See Combined Joint Stipulation of Facts & Statement of Issues Presented (Feb. 14, 2003). This stipulation, which the parties never amended or withdrew, did not mention the other three deficiency findings -- tags F492, F496, or F497 - from the August 2002 survey. Later, however, in its briefs to the ALJ, Golden Age argued that CMS had failed to substantiate the findings under these three tags and asked that they be removed from the Statement of Deficiencies. GA's Initial Br. to the ALJ (Sept. 5, 2003) at 22-26; GA's Rebuttal Br. to the ALJ (Sept. 19, 2003) at 2-3. The ALJ addressed this request indirectly by stating that although deficiencies other than tag F324 had been cited by the surveyors, "CMS did not seek to impose any remedy based upon those deficiencies and they are not subject to appeal or my review." ALJ Decision at 8.

The ALJ's decision not to address tags F492, F496, and F497 was legally correct. A SNF may appeal a finding of noncompliance if it results in the imposition of a CMP or other remedy specified in 42 C.F.R. § 488.406. 42 C.F.R. §§ 488.408(g)(1) and 498.3(b)(13); Park Manor Nursing Home, DAB No. 2005 (2005); Fountain Lake Health and Rehabilation, Inc., DAB No. 1985 (2005). The only remedy at issue in this appeal is a $3,100 per instance CMP. According to CMS's September 9, 2002 remedy notice, the CMP was imposed "for the deficiency cited at tag F324." CMS Ex. 1 (italics added). It is apparent, then, that tags F492, F496, and F497 did not result in the imposition of a remedy, and Golden Age does not assert otherwise. Because those tags did not result in the imposition of a remedy, Golden Age had no right to a hearing on them. Accordingly, we affirm the ALJ's decision not to review tags F492, F496, and F497.

5. Golden Age has identified no grounds to disturb the ALJ's finding that the amount of the CMP is reasonable.

[Page 20] Golden Age asserts that reversing the immediate jeopardy determination and removing tags F492, F496, and F497 requires a reevaluation of whether the amount of the CMP is reasonable. GA Br. at 43. This assertion is clearly meritless because CMS imposed the CMP based solely on tag F324 and because the immediate jeopardy finding is not clearly erroneous. In addition, Golden Age does not contend that the ALJ erred in his evaluation of the CMP's reasonableness based on his findings about tag F324. (8) Consequently, we affirm his finding that the amount of the CMP was reasonable.

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