Prestonsburg Health Care Facility, DAB CR5265 (2019)

DECISION

Prestonsburg Health Care Facility (Petitioner or facility) is a skilled nursing facility (SNF) that participates in the Medicare program. Based on a survey completed on July 30, 2015, the Centers for Medicare & Medicaid Services (CMS) determined that Petitioner was not in substantial compliance with the following Medicare program participation requirements: 42 C.F.R. §§ 483.10(d)(3), 483.20(d), (g)-(j), (k)(1), (k)(2), 483.25(h), 483.65. CMS further determined that Petitioner’s noncompliance with 42 C.F.R. §§ 483.10(d)(3), 483.20(k)(2), 483.25(h) posed immediate jeopardy to Petitioner’s residents from April 12, 2015 through July 29, 2015. CMS imposed a $3,550.00 per-day civil money penalty (CMP) on Petitioner, effective April 12, 2015 through July 29, 2015, and a $100.00 per-day CMP effective July 30, 2015 through September 30, 2015, for a total CMP of $393,250.00, as well as a denial of payment for new admissions (DPNA) from September 24, 2015 through September 30, 2015.

Petitioner requested a hearing to challenge CMS’s initial determination. Specifically, Petitioner challenges the immediate jeopardy level deficiencies, the duration of the alleged immediate jeopardy, and the reasonableness of the $3,550.00 per-day CMP for

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those deficiencies. Petitioner does not challenge the remaining deficiencies, the DPNA, or the amount or duration of the $100 per-day CMP.

As explained below, I conclude that (1) Petitioner did not substantially comply with the Medicare program participation requirements found at 42 C.F.R. §§ 483.20(k)(2) and 483.25(h); (2) CMS did not clearly err in determining that Petitioner’s noncompliance with 42 C.F.R. §§ 483.20(k)(2) and 483.25(h) posed immediate jeopardy to resident health and safety from April 12, 2015 through July 29, 2015; and (3) the $3,550 per-day CMP is reasonable in amount and duration. Because these conclusions are fully supported by the facts related to a single resident, Resident 8, this decision focuses on those facts and that resident.

Unless otherwise indicated, citations to the Code of Federal Regulations and references to CMP amounts are to those that were in effect at the time of the survey.

I. Background

The Social Security Act (Act) sets forth requirements for the participation of an SNF in the Medicare program and authorizes the Secretary of Health and Human Services (the Secretary) to promulgate regulations implementing those statutory provisions. 42 U.S.C. § 1395i-3. The regulations are found at 42 C.F.R. Parts 483 and 488. To participate in the Medicare program, an SNF must maintain substantial compliance with program participation requirements. See 42 U.S.C. §1395i-3(a)(3). To be in substantial compliance, an SNF’s deficiencies may “pose no greater risk to resident health or safety than the potential for causing minimal harm.” 42 C.F.R. § 488.301. A deficiency is a violation of a participation requirement established by 42 U.S.C. § 1395i-3(b), (c), or (d), or the regulations at 42 C.F.R. pt. 483, subpt. B. “Noncompliance” means “any deficiency that causes a facility to not be in substantial compliance.” 42 C.F.R. § 488.301. Broadly, noncompliance that subjects an SNF to enforcement remedies is divided into deficiencies that immediately jeopardize the health or safety of residents and those that do not. 42 U.S.C. §1395i-3(h)(1). Within the latter category, a facility may violate a statutory or regulatory requirement, but not be subject to enforcement remedies if the violation does not pose a risk for more than minimal harm. 42 C.F.R. §§ 488.402(b), 488.301.

The Secretary contracts with state agencies to conduct surveys to determine whether SNFs are in substantial compliance. 42 U.S.C. §§ 1395aa(a), 1395i-3(g); 42 C.F.R. § 488.10. The Act also authorizes the Secretary to impose enforcement remedies against SNFs that are not in substantial compliance with the program participation requirements. 42 U.S.C. § 1395i-3(h)(2); 42 C.F.R. § 488.406. One of the enforcement remedies is a CMP. 42 U.S.C. § 1393i-3(h)(2)(B)(ii). CMS may impose a per‑day CMP for the number of days an SNF is not in substantial compliance or a per-instance CMP for each instance of the SNF’s noncompliance. 42 U.S.C. § 1393i-3(h)(2)(A), (h)(2)(B)(ii)(I);

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42 C.F.R. § 488.430(a). A per-day CMP may range from either $50 to $3,000 per day for less serious noncompliance, or $3,050 to $10,000 per day for more serious noncompliance that poses immediate jeopardy to the health and safety of residents. 42 C.F.R. § 488.438(a)(1). “Immediate jeopardy” exists when “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.

If CMS imposes a CMP based on a noncompliance determination, then the facility may request a hearing before an administrative law judge (ALJ) to challenge the noncompliance finding and enforcement remedy. 42 U.S.C. §§ 1320a-7a(c)(2), 1395i-3(h)(2)(B)(ii); 42 C.F.R. §§ 488.408(g), 488.434(a)(2)(viii), 498.3(b)(13); see also 5 U.S.C. §§ 554, 556. The hearing before an ALJ is a de novo proceeding. CarePlex of Silver Spring, DAB No. 1683 (1999) (holding that ALJs hold de novo hearings based on issues permitted under the regulations and ALJ review is not a quasi-appellate review); see also Claiborne-Hughes Health Ctr. v. Sebelius, 609 F.3d 839, 843 (6th Cir. 2010) (The Departmental Appeals Board (DAB) “reviewed the finding under the de novo standard that the ALJ would have applied.”). A facility has a right to appeal a “certification of noncompliance leading to an enforcement remedy.” 42 C.F.R. § 488.408(g)(1); see also 42 C.F.R. §§ 488.330(e), 498.3. However, CMS’s choice of remedies and the factors CMS considers when choosing remedies are not subject to review. 42 C.F.R. § 488.408(g)(2).

In regard to the burden of proof, CMS must make a prima facie case that the SNF failed to comply substantially with federal participation requirements and, if this occurs, the SNF must, in order to prevail, prove substantial compliance by a preponderance of the evidence. Hillman Rehab. Ctr., DAB No. 1611 at 8 (1997); see Batavia Nursing & Convalescent Inn, DAB No. 1911 (2004); Batavia Nursing & Convalescent Ctr., DAB No. 1904 (2004), aff’d, Batavia Nursing & Convalescent Ctr. v. Thompson, 129 F. App’x 181 (6th Cir. 2005); Emerald Oaks, DAB No. 1800 (2001).

Petitioner is an SNF that operates in Prestonsburg, Kentucky. The Kentucky Office of Inspector General (state agency) conducted a survey of Petitioner that concluded on July 30, 2015. CMS Exhibit (Ex.) 1 at 1. The state agency issued a Statement of Deficiencies (SOD) that concluded the facility was not in substantial compliance. CMS Ex. 1 at 1. Relevant to this case, the state agency found the following deficiencies at the immediate jeopardy level from April 12, 2015 through July 29, 2015:

• 42 C.F.R. §§ 483.10(d)(3), 483.20(k)(2) (Tag F280) (right to participate in planning care-revised care plan) at a scope and severity level of “J.”
• 42 C.F.R. § 483.25(h) (Tag F323) (accident prevention and adequate supervision) at a scope and severity level of “J.”

CMS Ex. 1 at 13-46.

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I note that for Tag F280, the SOD alleged noncompliance with 42 C.F.R. §§ 483.20(d)(3) and 483.10(k)(2). CMS Ex. 1 at 13. This citation appears to be a typographical error because Appendix PP (Guidance to Surveyors of Long Term Care Facilities) to CMS’s State Operations Manual indicates that Tag F280 is based on §§ 483.10(d)(3) and 483.20(k)(2), and not §§ 483.20(d)(3) and 483.10(k)(2). Further, the regulatory language used and the substance of the allegations in the SOD indicate that the state agency found violations of §§ 483.10(d)(3) and 483.20(k)(2). CMS Ex. 1 at 13-28.

Further, the SOD’s reference to a scope and severity level of “J,” indicates isolated immediate jeopardy to resident health or safety. See State Operations Manual ch. 7, § 7400E. Finally, the SOD’s factual narrative for these two deficiencies primarily concern a series of falls suffered by Resident 8, who died 11 days after her last fall.

In response to the state agency’s findings, Petitioner filed a plan of correction (POC) on or about July 30, 2015. CMS Ex. 3 at 1-5. The POC identified 13 steps Petitioner would take to remove the immediate jeopardy conditions the state agency alleged existed in the facility. Id. The POC asserted that immediate jeopardy was removed on July 30, 2015. The state agency accepted Petitioner’s POC and found that Petitioner removed immediate jeopardy on the date alleged in the POC. See CMS Ex. 1 at 1.

CMS, in its September 9, 2015 initial determination, adopted the state agency survey findings and imposed a $3,550 per day CMP from April 12, 2015 through July 29, 2015, based on alleged immediate jeopardy level violations of 42 C.F.R. §§ 483.10(d)(3), 483.20(k)(2), and 483.25(h). CMS Ex. 2. Ultimately, CMS imposed CMPs at $100 per day for 63 days from July 30, 2015 to September 30, 2015, and a DPNA from September 24, 2015 to September 30, 2015. CMS Ex. 2; Petitioner’s (P.) Ex. 6.

Petitioner requested a hearing before an ALJ to dispute CMS’s initial determination. Petitioner generally challenged “the cited deficiencies, especially the immediate jeopardy allegations, the duration of the immediate jeopardy and the reasonableness of the CMP.” Request for Hearing at 2. After I was assigned to hear and decide this case, I issued an Acknowledgment and Pre-hearing Order that established a prehearing submission schedule.

In accordance with the schedule, CMS filed a prehearing brief and 49 proposed exhibits (CMS Exs. 1-49), which included written direct testimony for witnesses. Several days later, CMS filed amended versions of CMS Exs. 26, 27, and 33. DAB Efile Docket Entries 14, 14a, 14b. Petitioner timely filed a prehearing brief and then an amended prehearing brief (labeled as a “CLEAN COPY”) at DAB Efile Docket Entry 34 (P. Pre-hrg. Br.) and 17 proposed exhibits (P. Exs. 1-17), which included written direct testimony for witnesses as well as objections to CMS Exs. 43 and 49, and portions of CMS’s prehearing brief. CMS timely filed notice of its intent to cross-examine Petitioner’s

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witnesses; Petitioner thereafter untimely filed notice of its similar intent to cross-examine CMS’s witnesses. See Ack. & Pre-hrg. Order at 6.

In an April 6, 2016 notice, I scheduled the case for a hearing by video teleconference. Thereafter, Petitioner moved for a continuance and rescheduling of the hearing. By order dated November 10, 2016, I postponed the hearing. In a new notice, dated November 22, 2016, I rescheduled the hearing.

Before the rescheduled hearing, on March 10, 2017, CMS moved for leave to supplement its prehearing exchange and requested that I admit rebuttal evidence. CMS filed six additional proposed exhibits (CMS Exs. 50-55). Petitioner opposed CMS’s motion.

Also before the hearing, CMS filed a motion requesting a subpoena for one of CMS’s witnesses, Surveyor Patricia Liford, who had previously worked as a state surveyor and provided written direct testimony for this case (CMS Ex. 45), but subsequently obtained employment with Petitioner’s corporate parent. In a March 30, 2017 order, I denied CMS’s request for a subpoena and, given Ms. Liford’s change in employment, ordered Petitioner to produce Ms. Liford at the hearing, if Petitioner still wished to cross-examine her. I gave the parties 10 days to object to the March 30, 2017 order. On April 3, 2017, Petitioner moved to exclude Ms. Liford’s written direct testimony if she did not appear at the hearing for cross-examination. I construed this motion as an objection to my March 30, 2017 order and overruled the objection by order dated April 5, 2017. I noted that if Petitioner did not produce Ms. Liford at the hearing, I would treat her failure to appear as a waiver of Petitioner’s right to cross-examine her.

I held a video hearing from April 25, 2017 through April 27, 2017, at which Petitioner’s counsel cross-examined CMS’s four witnesses (Patricia Liford, Debra Beth Cima, OraMae Roark, and Melanie Richardson) and CMS counsel cross-examined Petitioner’s eight witnesses (Dr. Larry Leslie, Ilene Warner-Maron, Lynn Watts, Jon Stanley Go, Kelli Nelson, Melanie Slone, Crystal J. Wireman, and Clinton M. Caudill). Hearing Transcript (Tr.)1  v.1 at 3, v.2 at 3, v.3 at 3. During the hearing, I admitted into the record CMS Exs. 1-25, 28-32, 34-49; the amended versions of CMS Exs. 26, 27, and 33; and P. Exs. 1-17. Tr. v.1 at 7-17. I did not admit proposed CMS Exs. 50-55 into the record. Tr. v.1 at 14-16. I also admitted into the record an additional exhibit from CMS, Tr. v.1 at 367, which CMS later marked and filed as CMS Ex. 56, DAB Efile Docket Entry 54.

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After the hearing, CMS and Petitioner filed post-hearing briefs (CMS Br. and P. Br.) and reply briefs (CMS Reply and P. Reply). CMS also filed a list of transcript errata.

In post-hearing briefing, CMS again sought admission of CMS Exs. 50-55. CMS Br. at 16 n.5. Petitioner objected. P. Reply at 2. I decline to reconsider my ruling on those exhibits.

In the first footnote of its post-hearing reply brief, Petitioner noted: “In an effort to clarify the issues before the ALJ, Prestonsburg is only challenging 1) the two immediate jeopardy level deficiencies, 2) the duration of the alleged immediate jeopardy, and 3) the reasonableness of the CMP.” In this decision I focus on these issues. Therefore, CMS’s determinations as to the non-immediate jeopardy deficiencies, $100 per-day CMP, and DPNA are now binding. See 42 C.F.R. § 498.20(b)(2).

Although Tag F280 references the Medicare program participation requirements at 42 C.F.R. §§ 483.10(d)(3) and 483.20(k)(2), see CMS Ex. 1 at 13-14, CMS’s briefing related to that tag focuses on Petitioner’s noncompliance with 42 C.F.R. § 483.20(k)(2). CMS Br. at 23-24; CMS Reply at 2. Therefore, in this decision, I only discuss the alleged violation of § 483.20(k)(2) in relation to Tag F280. See Claiborne-Hughes, 609 F.3d at 847.

Shortly after receiving the parties’ post-hearing submissions, I began hearing and deciding cases in another component of the Department of Health and Human Services, and a different ALJ was assigned to this case. However, upon my return to this component, this case was again assigned to me and, as the ALJ who held the hearing in this case, I issue this decision.

II. Issues

1. Whether Petitioner failed to comply substantially with the requirements of 42 C.F.R. § 483.20(k)(2) (Tag F280), relating to the right to participate in planning care-revised care plan);
2. Whether Petitioner failed to comply substantially with the requirements of 42 C.F.R. § 483.25(h) (Tag F323, relating to accident prevention and adequate supervision);
3. If Petitioner was not substantially compliant with 42 C.F.R. §§ 483.20(k)(2), 483.25(h), whether CMS’s immediate jeopardy determination was clearly erroneous; and
4. Whether the $3,550 per-day CMP that CMS imposed is reasonable.

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III. Jurisdiction

I have the authority to decide the issues in this case. 42 U.S.C. §§ 1320a-7a(c)(2), 1395i-3(h)(2)(B)(ii); 42 C.F.R. §§ 498.3(b)(13), (14), 498.60(c).

IV. Findings of Fact

1. Petitioner is an SNF located in Prestonsburg, Kentucky, that participates in Medicare. CMS Ex. 1 at 1; CMS Ex. 2.

1. At all times relevant to this proceeding, Petitioner had a policy related to comprehensive care plans. CMS Ex. 38. The policy was to develop for each resident “[a]n individualized comprehensive care plan that includes measurable objectives and timetables to meet the resident’s medical, nursing, mental and psychological needs . . . .” Id. at 1. The care planning and interdisciplinary team (IDT), in coordination with the resident and the resident’s family or representative, was responsible for developing and maintaining the resident’s comprehensive care plan. Id. The IDT was to consider carefully the resident’s problems, and their causes, when designing interventions to address those problems. Id. Interventions were supposed to address the underlying source(s) of problems, not just symptoms or triggers. Id. The policy “recognized that care planning individual symptoms or Care Area Triggers in isolation may have little, if any, benefit for the resident.” Id. The policy also noted that an interdisciplinary process is necessary to identify problem areas and their causes, as well as to develop targeted, meaningful interventions. Id. According to the policy, “[t]he resident’s physician . . . is integral to this [interdisciplinary] process.” Id. The IDT was responsible for reviewing and updating the care plan quarterly and whenever the resident experienced a significant change in condition. Id. at 2.

1. Petitioner also had a policy related to falls. CMS Ex. 39. The policy was “to provide residents with assistance and supervision to minimize the risk of falls and fall related injuries.” Id. at 1. The procedures to implement the policy include:

1. All residents were to have comprehensive fall risk assessments on admission, quarterly, and with a significant change in status;
2. Staff were to review a resident’s care plan after each fall, with care plan revisions as indicated by the assessment;
3. For each fall, staff were to, among other things, investigate the circumstances of the fall, document the investigation, determine the root cause of the fall (if possible), update the resident’s care plan, and add the resident’s name to a 24-hour report for at least 72 hours for follow up charting; and

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1. The director of nursing (DON), or designee, was to review the resident’s fall and care plan daily for at least three days, continue the root cause analysis, and identify whether other residents were at risk and, if so, take appropriate action.

Id. at 1-2.

1. Resident 8 originally was admitted to the facility on January 19, 2009, with diagnoses of end stage Alzheimer’s disease, hypertension, and psychosis. CMS Ex. 4; Tr. v.1 at 285; see also CMS Ex. 5 at 4, 15-16 (February 24, 2015 Minimum Data Set (MDS) for Resident 8).

1. Resident 8’s condition worsened over time, and she later was diagnosed with, among other things, osteoporosis, anxiety, depression, difficulty in walking, pulmonary embolism and infarction, acute venous embolism and thrombosis of the lower extremities, abnormal posture, and lack of coordination. Tr. v.1 at 285; CMS Ex. 4 at 2.

1. Resident 8 was severely cognitively impaired. Tr. v.1 at 327. She also suffered impairment of both lower extremities, and she needed a wheelchair to ambulate and assistance of two staff with a mechanical lift to transfer. CMS Ex. 5 at 13; CMS Ex. 6 at 1, 3, 5; CMS Ex. 8 at 1; P. Ex. 1 at 2, 75-79; Tr. v.1 at 290-93, 326.

1. Resident 8 was at risk for falls throughout her stay at the facility. CMS Ex. 6 at 1, 3, 5; CMS Ex. 18 at 1; P. Ex. 1 at 14, 17, 22, 26, 28, 32, 36, 40, 44, 47, 49, 51, 62, 66, 70, 72-73, 118.

1. While sitting in her wheelchair on July 26, 2011, Resident 8 leaned forward and fell, striking her head against a wall. Tr. v.1 at 315, 317, 326.

1. On June 11, 2012, Resident 8 again fell forward out of her wheelchair; in response, Petitioner sent her to the emergency room. Tr. v.1 at 318-19, 326; CMS Ex. 6 at 1; CMS Ex. 12 at 21; P. Ex. 1 at 51.

1. On November 22, 2012, Resident 8 once more fell forward out of her wheelchair. Tr. v.1 at 322-23, 326; Tr. v.2 at 197; CMS Ex. 6 at 1, 3; P. Ex. 1 at 49, 51.

1. On November 23, 2012, Resident 8’s IDT assessed Resident 8 for use of restraints, which revealed that, among other things, Resident 8 fell forward, fell or leaned sideways in both directions, slid down, was unable to recover her balance while sitting and leaning forward or backward. CMS Ex. 7; see also Tr. v.1 at 327.

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1. Resident 8’s IDT recommended giving Resident 8 a lap buddy, which is a cushioned device that spans the distance between arms of a wheelchair and rests above the wheelchair occupant’s lap. CMS Ex. 7; CMS Ex. 45 at 2 ¶ 10; see also CMS Ex. 11 at 1-2 (example picture of a lap buddy).

1. A lap buddy creates a physical barrier that inhibits the wheelchair occupant from exiting the wheelchair, and it can help to improve the occupant’s positioning in the wheelchair and prevent the occupant from leaning forward. CMS Ex. 45 at 2 ¶ 10; CMS Ex. 11 at 2.

1. Resident 8’s primary care physician, Dr. Leslie, was not part of Resident 8’s IDT and did not participate in her quarterly care plan conferences or in assessing her for use of a lap buddy, but he ordered the lap buddy at the IDT’s recommendation. Tr. v.1 at 286, 325-26.

1. On December 11, 2012, Petitioner conducted a physical restraint elimination review in which it noted that Resident 8 “lean[ed] forward at times [and was] not able to safely or adequately regain balance.” CMS Ex. 8 at 1-2; see also Tr. v.1 at 327.

1. On February 8, 2013, Petitioner conducted another physical restraint elimination review. CMS Ex. 8 at 1-2. This review contains contradictory information; on the first page of the review, the box indicating that Resident 8 leaned forward while sitting is checked, but the second page contains a note stating that “staff report resident is no longer leaning forward” and that she was “a good candidate for restraint reduction.” Id. The review also indicates that Resident 8 had fallen within the last 30 days. Id. at 1.

1. Beginning February 13, 2013, Petitioner’s staff gave Resident 8 a breakaway lap buddy, which is a lap buddy that is “connected in the middle with Velcro,” in place of a regular lap buddy. Id. at 2; CMS Ex. 45 at 4 ¶ 13; see also CMS Ex. 11 at 3-8 (example pictures of two variations of breakaway lap buddies); P. Ex. 10 at 5 ¶ 28; Tr. v.1 at 330.

1. On February 24, 2013, Resident 8 fell out of her wheelchair. CMS Ex. 6 at 3; P. Ex. 1 at 49, 108; P. Ex. 15 at 2 ¶ 6. She fell through the breakaway lap buddy while “reaching for something on the floor in front of her” because she lost her balance and could not regain it. Tr. v.2 at 26.

1. On March 4, 2013, Petitioner conducted a final physical restraint elimination review. CMS Ex. 8 at 1. The first page of the review again indicates that Resident 8 leaned forward while sitting and had fallen within the last 30 days. Id. at 1.

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1. On March 29, 2013, Resident 8 fell, lacerating her finger. Tr. v.1 at 331-32.

1. On October 21, 2013, Resident 8 fell again, suffering “injuries . . . consistent with a fall forward out of a wheelchair,” including a cephalohematoma (i.e., an accumulation of blood under the scalp). Tr. v.1 at 333-35; CMS Ex. 12 at 2, 21.

1. On January 18, 2014, Resident 8 injured her head by scraping it on the edge of a tabletop after leaning forward in her wheelchair. Tr. v.1 at 336-38.

1. The record contains two care plans related to Resident 8’s fall risk, the first with a beginning date of March 7, 2014, the second with a beginning date of December 9, 2014. CMS Ex. 18 at 1; P. Ex. 1 at 70-73.

1. The March 7, 2014 falls care plan noted that Resident 8 was at risk for fall related injury due to her consistently-elevated fall risk scores and history of falls. P. Ex. 1 at 70. The care-planned goal was for Resident 8 to suffer no fall-related injuries, with approaches to advance that goal including:

1. using fall risk screens quarterly to identify fall-related risk factors;
2. reporting falls to Resident 8’s physician and responsible party;
3. observing for and reporting to Resident 8’s physician any drug side effects that might increase her fall risk (e.g., gait disturbance, weakness, sedation, etc.);
4. providing appropriate environmental adaptations, such as a low/platform bed, ensuring Resident 8’s call light was within reach, ensuring she had adequate glare-free lighting, and keeping area free of clutter;
5. monitoring Resident 8’s wheelchair usage;
6. reminding Resident 8 and reinforcing her safety awareness related to the lock brakes on her bed and chair before transfers, the need to rest on the side of the bed for a few minutes before transfers, the need to request assistance before ambulating, and wearing appropriate footwear;
7. facilitating Resident 8’s attendance at programs consistent with her interests and enhancing her physical strength; and
8. referring Resident 8 for physical and occupational therapy screening and treatment as needed.

Id. at 70-71.

1. On March 27, 2014, Resident 8 was sitting in her wheelchair in the dining room when she leaned over to reach for her baby doll and fell forward through the breakaway lap buddy and out of the wheelchair. CMS Ex. 14 at 1; P. Ex. 1 at 91, 109-10; Tr. v. 1 at 339-341. She landed on her right side, hitting her head on the floor, and suffered bruising and a hematoma measuring 4cm by 5cm to the right

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1. side of her head. CMS Ex. 14 at 1-2; P. Ex. 1 at 91-92, 110. Factors contributing to her fall included a history of falls, forgetting to ask for help, confusion, poor balance, anxiety, poor safety awareness, and unsteady gait. CMS Ex. 14 at 1; P. Ex. 1 at 91. Despite listing all these contributing factors, the clinical team reviewing the fall determined that the doll was the root cause of the fall. P. Ex. 17 at 2 ¶ 8; Tr. v.3 at 11-12.

1. In the immediate aftermath of the March 2014 fall, Petitioner in-serviced its staff to return Resident 8 to bed after breakfast. CMS Ex. 14 at 1-2; P. Ex. 1 at 85-86; Tr. v.3 at 14. Petitioner also added the following intervention to her then-current care plan: “inservice staff to have doll in hand always.” P. Ex. 1 at 71; see also Tr. v.2 at 24-25; Tr. v.3 at 12-13. Such an in-service was provided that same day. P. Ex. 1 at 83-84.

1. Dr. Leslie was not involved in the specifics of the updated interventions; he left the “specifics” to “the physical therapist and the nursing staff” subject to his general oversight. Tr. v.1 at 287, 343-44.

1. On September 14, 2014, Resident 8 fell out of her bed. P. Ex. 1 at 26, 28, 62; Tr. v.2 at 199.

1. Following the September 2014 fall, Resident 8 was referred to physical therapy for evaluation and treatment. P. Ex. 1 at 117-20.

1. On September 15, 2014, Jon Stanley Go, PT, evaluated Resident 8 and developed a physical therapy plan of treatment. P. Ex. 1 at 117-20. His evaluation revealed that: she had a history of falling out of her wheelchair, she “falls forward” and “som[e]times reached for things on the floor,” her head was forward, her poor posture limited her ability to reposition herself and self-propel in her wheelchair, she was not always able to self-correct when she lost her balance, and she had fixed (i.e., permanent) cervical kyphosis, which meant she was “hunched over.” P. Ex. 1 at 118-19; Tr. v.2 at 38-39, 52, 200-01, 209-10. In September 2014, Mr. Go did not yet have a DPT degree, but he received the degree in August of 2015. P. Ex. 16 at 1 ¶ 1.

1. The December 9, 2014 care plan related to Resident 8’s falls again noted that she was at risk for fall-related injury. CMS Ex. 18 at 1; P. Ex. 1 at 72-73. The care-planned goal was the same as the goal of the March 7, 2014 care plan: for Resident 8 to suffer no fall-related injuries. CMS Ex. 18 at 1; P. Ex. 1 at 72-73. The approaches to advance that goal largely, though not entirely, mirror the interventions from the March 7, 2014 care plan, including:

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1. using fall risk screens quarterly to identify fall-related risk factors;
2. reporting falls to Resident 8’s physician and responsible party;
3. observing for and reporting to Resident 8’s physician any drug side effects that might increase her fall risk (e.g., weakness, sedation, lightheadedness, dizziness, etc.);
4. providing appropriate environmental adaptations, such as a low/platform bed, ensuring Resident 8’s call light was within reach, ensuring she had adequate lighting, and keeping area free of clutter;
5. monitoring for appropriate footwear;
6. engaging a pharmacy consultant or physician to review Resident 8’s medication usage for possible reductions;
7. referring Resident 8 to therapy as needed; and
8. referring Resident 8 to a doctor as needed for specialist consultations.

CMS Ex. 18 at 1; P. Ex. 1 at 72-73.

1. On February 24, 2015, Petitioner performed a quarterly assessment for Resident 8 using the MDS version 3.0. CMS Ex. 5.

1. The February 2015 MDS revealed that Resident 8 was totally dependent on facility staff for bed mobility, transfers, toilet use, and personal hygiene. CMS Ex. 5 at 12. At no point did she walk, with or without assistance, and she required extensive assistance for dressing, eating, and locomotion on and off the unit while in her wheelchair. Id.; see also P. Ex. 1 at 118. For bed mobility and transfers, she required assistance from two or more staff members (with a mechanical lift for transfers); for locomotion on and off the unit, she required assistance from one staff member. CMS Ex. 5 at 12; see also P. Ex. 1 at 79. During surface-to-surface transfers, she was not steady and could only stabilize herself with staff assistance. CMS Ex. 5 at 13. In addition, her cognitive skills continued to be severely impaired, her speech was unclear, and she was rarely or never understood by facility staff, making it impossible for Petitioner to conduct a brief interview for mental status to assess her mental functioning. Id. at 6-8.

1. On February 26, 2015, Petitioner conducted a care plan conference for Resident 8. The conference attendees did not specifically discuss Resident 8’s fall history or care plan related to falls. CMS Ex. 36 at 257; P. Ex. 1 at 76. The conference summary contains only general notes, such as that the resident did not undergo any significant changes, that the care team reviewed and updated care plans, and that Petitioner would continue with the current care plan. CMS Ex. 36 at 257; P. Ex. 1 at 76.

1. On March 5, 2015, Resident 8 again fell forward through her breakaway lap buddy out of her wheelchair. CMS Ex. 15 at 1; CMS Ex. 12 at 1; Tr. v.1 at 348-49. She

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1. fell in the dining room after leaning forward to pick up a cup off the floor, hitting her head on the floor. CMS Ex. 15 at 1; P. Ex. 11 at 2 ¶ 8; P. Ex. 17 at 2 ¶ 9; Tr. v.1 at 287; Tr. v.2 at 25. She suffered a laceration, approximately 3cm in length, to her left forehead with a moderate amount of blood. CMS Ex. 15 at 1; CMS Ex. 12 at 1-2, 21. The only factors contributing to her fall that Petitioner identified were that she was leaning out of her wheelchair to pick up an object on the floor (a cup) and the Velcro of her breakaway lap buddy “came unstuck” due to her weight. CMS Ex. 15 at 2; see also P. Ex. 14 at 5 ¶ 24; P. Ex. 15 at 2 ¶ 11; P. Ex. 17 at 2 ¶ 9; Tr. v.2 at 25. The clinical team reviewing the fall determined that the cup on the floor was the root cause of the fall. CMS Ex. 15 at 2; P. Ex. 15 at 2 ¶ 11; P. Ex. 17 at 2 ¶ 9; Tr. v.3 at 15.

1. Following the March 2015 fall, Petitioner sent Resident 8 to the emergency room. CMS Ex. 15 at 1; CMS Ex. 12 at 1. A CT scan revealed soft tissue swelling with no acute intracranial bleed or fracture. CMS Ex. 12 at 2-3.

1. As an initial intervention to the March 2015 fall, Petitioner notified therapy staff of the fall. CMS Ex. 15 at 2. Petitioner noted the fall on Resident 8’s care plan and added as an intervention “inservice staff to not leave cups (stuff from hydration) with resident.” CMS Ex. 18 at 1; P. Ex. 1 at 72-73; see also P. Ex. 14 at 5 ¶ 24; P. Ex. 15 at 2 ¶ 11; P. Ex. 17 at 2 ¶ 9; Tr. v.2 at 25. The same day as the fall, Petitioner’s DON, Kelli Nelson, in-serviced staff that they should not leave cups with Resident 8 when giving her hydration. P. Ex. 1 at 87-88; see also P. Ex. 14 at 5 ¶ 24; P. Ex. 15 at 2 ¶ 11; P. Ex. 17 at 2 ¶ 9.

1. On April 12, 2015, Resident 8 once more fell forward through her breakaway lap buddy out of her wheelchair. CMS Ex. 16 at 1; CMS Ex. 13 at 1; P. Ex. 1 at 93; Tr. v.1 at 354, 357-58. Similar to her March 2014 and March 2015 falls, Resident 8 fell in the dining room after leaning forward to pick up an object, this time paper, off the floor, again hitting her head on the floor. CMS Ex. 16 at 1; CMS Ex. 13 at 1; P. Ex. 1 at 93, 111-12; Tr. v.1 at 354, 357-58. Among other things, she again suffered a laceration to her left side forehead, this one measuring 2cm but with a large amount of blood. CMS Ex. 16 at 1-2; CMS Ex. 13 at 1, 29; P. Ex. 1 at 93-94, 111-12. The fall also “caused bleeding in her brain.” Tr. v.1 at 361. Petitioner listed a host of factors contributing to this fall, including: history of falls, lower extremity weakness, forgot to ask for help, incontinence of bowel and bladder, noncompliance with safety interventions, poor mobility, confusion, anxiety, difficulty maintaining sitting balance, and poor safety awareness. CMS Ex. 16 at 1; P. Ex. 1 at 93. Despite listing all these contributing factors, the clinical team reviewing the fall determined that the piece of paper on the floor was the root cause of the fall. P. Ex. 14 at 5 ¶ 25; P. Ex. 17 at 2 ¶ 10; Tr. v.3 at 16.

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1. Following the April 2015 fall, Petitioner sent Resident 8 to the emergency room. CMS Ex. 16 at 2; CMS Ex. 13; P. Ex. 1 at 94. Testing revealed that, in addition to her other injuries, Resident 8 also suffered a closed head injury, which is “a trauma in which the brain is injured.” CMS Ex. 13 at 4; Tr. v.1 at 352.

1. In the nursing assessment documenting Resident 8’s April 2015 fall, Petitioner did not note any new nursing interventions. CMS Ex. 16 at 1; P. Ex. 1 at 93. The day of the fall, though, Petitioner noted the fall in her care plan and added the following two new interventions: “[i]nservice staff to keep dining room free of paper/clutter” and “refer[r]al to therapy.” CMS Ex. 18 at 1; P. Ex. 1 at 72-73. That same day, Petitioner’s assistant DON, Crystal Wireman, in-serviced staff that they should keep the dining room free of paper or clutter to prevent Resident 8 from leaning over to pick up things. P. Ex. 1 at 89-90; P. Ex. 14 at 5 ¶ 25; P. Ex. 17 at 2 ¶ 10; Tr. v.3 at 17.

1. Resident 8 returned from the hospital to the facility on April 17, 2015. CMS Ex. 13 at 19-21; P. Ex. 1 at 113. Her condition “had dramatically changed. She was no longer able to move about the Facility by propelling herself in the wheelchair.” P. Ex. 15 at 3 ¶ 18. Further, “she was unable to sit up . . . .” Id. Upon her return, Petitioner requested therapy evaluation for her. Id. On April 20, 2015, she was assessed for occupational therapy. P. Ex. 1 at 101-04. She “exhibit[ed] only reflex movements, no meaningful [range of motion] or visual tracking with any therapist facilitated activities.” P. Ex. 1 at 103.

1. Resident 8 died on April 23, 2015. CMS Ex. 56.

1. Resident 8’s death was caused, at least in part, by her fall on April 12, 2015. Tr. v.1 at 362-63.

1. The state agency conducted a survey at Petitioner’s facility from July 22, 2015 through July 30, 2015. CMS Ex. 1 at 1. The state agency found conditions that it determined posed immediate jeopardy to the health and safety of Petitioner’s residents. Id. at 1, 15, 29.

1. In response to the state agency’s findings of immediate jeopardy, Petitioner generated a POC in which it alleged it had removed the immediate jeopardy conditions. CMS Ex. 3 at 1-5. The POC details thirteen steps Petitioner would take to abate immediate jeopardy and return to substantial compliance. Id. Critically, Petitioner noted that it would review all residents’ accident/incident reports from the past 90 days “to include not just the individual incident/accident but a more global approach by reviewing the tracking/trending of individual resident falls . . . .” Id. at 2. This review was to “identify any safety concerns, ensure thorough investigation of all [accidents/incidents] was completed and

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1. implemented interventions on care plan address root cause.” Id. Petitioner planned to complete the review by July 24, 2015. Id. Following the review, Petitioner planned to audit all resident care plans to ensure they reflected “current resident safety care needs.” Id. at 2-3. The audit would begin “daily starting on 7/24/15 and continu[e] until immedia[te jeopardy wa]s lifted . . . .” Id. at 3. Petitioner also planned to educate its staff on its updated fall program and care plan policy, “to include revising and updating the care plan along with interventions that meet not only the individual accident/incident but also patterns identified from tracking and trending . . . .” Id. at 4.

1. The POC indicates that most employees were educated by July 26, 2015, but a dozen employees had not yet been educated by that date. Id. at 4. Petitioner alleged in the POC that it removed immediate jeopardy on July 30, 2015. The state agency accepted Petitioner’s POC and determined that immediate jeopardy ended on July 30, 2015. CMS Ex. 1 at 1, 15, 17, 24, 29, 35, 42. CMS adopted the state agency’s determination. CMS Ex. 2 at 1.

V. Conclusions of Law and Analysis

1. Petitioner was not in substantial compliance with 42 U.S.C. § 1395i-3(b)(2)(B) and 42 C.F.R. § 483.20(k)(2) (Tag F280) because Petitioner failed to update Resident 8’s care plan appropriately to prevent her from falling forward out of her wheelchair, and Petitioner’s failure contributed directly to her death.

Facilities “must develop a comprehensive care plan for each resident that includes measurable objectives and timetables to meet a resident’s medical, nursing, and mental and psychosocial needs that are identified in the comprehensive assessment.” 42 C.F.R. § 483.20(k)(1); see also 42 U.S.C. § 1395i-3(b)(2)(A). The care plan must be developed within seven days after the facility completes the comprehensive assessment, and it must be prepared by an interdisciplinary team that includes the resident’s attending physician. 42 U.S.C. § 1395i-3(b)(2)(B); 42 C.F.R. § 483.20(k)(2). A team of qualified persons must review and revise the plan after each assessment. 42 U.S.C. § 1395i-3(b)(2)(C); 42 C.F.R. § 483.20(k)(2). These requirements contain an implicit obligation for SNFs “to develop care plan revisions that meaningfully respond to challenges in a resident’s particular needs – which may . . . include a need for supervision.” Countryside Rehab. & Health Ctr., DAB No. 2853 at 20-21 (2018) (quoting Sheridan Health Care Ctr., DAB No. 2178 at 38 (2008)) (internal quotation marks omitted).

Petitioner violated these requirements in two respects. First, Resident 8’s primary care physician, Dr. Leslie, was not part of Resident 8’s IDT and did not participate in the discussion concerning what interventions to implement in response to Resident 8’s assessments and falls. Finding of Fact (FF) 14, 27. This violated not only the statute and

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regulation, but also Petitioner’s own care plan policy. See FF 2. Second, and more importantly, in the face of Resident 8’s repeated falls through the breakaway lap buddy and out of her wheelchair, Petitioner failed to revise Resident 8’s care plan in a meaningful way to respond to those falls, again in violation of the statute, regulation, and Petitioner’s own policy.

Resident 8 had a serious problem with falls. She continuously was at risk of falling while she resided at the facility. FF 7. Beginning at least as early as July 2011, Resident 8 began falling forward out of her wheelchair. FF 8. Although she did not fall in this manner with great frequency over the years, she did consistently fall out of her wheelchair at least once per year, and sometimes more often, prior to her death. FF 8-10, 18, 21, 25, 35, 38. On another occasion, she injured herself after leaning forward in her wheelchair, FF 22, and she fell in other ways, FF 20, 28. These falls were due in large part to her serious functional impairments, particularly her poor posture and impaired balance, and her tendency to lean forward in her wheelchair to pick up objects. FF 4-6, 11, 15-16, 18-19, 25, 33, 35, 38.

According to Petitioner’s own care plan policy, Resident 8’s IDT should have responded to these falls by carefully designing targeted, meaningful interventions to address the underlying source of the falls, not just the symptoms or triggers of a particular fall. FF 2. However, despite Resident 8’s problems and contrary to the care plan policy, in response to each of Resident 8’s three most recent falls from her wheelchair, Petitioner focused on the very narrow fact that specifically triggered the fall and added interventions to the care plan largely to address each specific trigger. For the March 2014 fall, the clinical team reviewing the fall focused on the doll that Resident 8 was reaching to pick up as the root cause of the fall, not the many other factors contributing to her fall. FF 25. The two interventions Petitioner added to the care plan in response to the March 2014 fall reflect this narrow focus, directing staff merely to return Resident 8 to bed after breakfast (but not at other times) and to ensure she had her doll in hand. FF 26. This care plan revision did not meaningfully address many of the other factors contributing to the fall, such as Resident 8’s confusion, anxiety, poor balance, and poor safety awareness. FF 25.

Petitioner’s response to the March 2015 fall was even more limited. The record shows that Resident 8’s condition had not changed meaningfully (and, if it had, it was for the worse) between the March 2014 and March 2015 falls. FF 30. Petitioner only identified two factors contributing to the fall: the empty cup on the floor for which Resident 8 was reaching and the fact that the Velcro of her breakaway lap buddy “came unstuck.” FF 35. This assessment simply is not credible. It contradicts the detailed September 2014 physical therapist assessment, which indicated that Resident 8 had a variety of problems with her balance and posture, as well as a habit of reaching for things (not just cups or her doll) that greatly increased the chances that she would fall in the manner she did in March 2015. FF 30. Yet the clinical team’s limited post-fall assessment led Petitioner to add to Resident 8’s care plan only one intervention to address her continued risk of falling out of

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her wheelchair: in-servicing staff to not leave cups with Resident 8. FF 37. This intervention did not address Resident 8’s poor balance and posture, and it did not address her propensity to reach for things other than cups on the floor. Thus, Petitioner’s revision of Resident 8’s care plan following the March 2015 fall again failed to meaningfully address Resident 8’s needs.

Petitioner’s response to Resident 8’s final fall in April of 2015 followed the same deficient pattern as its response to the March 2014 and March 2015 falls. Although Petitioner more fully identified the factors contributing to this fall, it again identified as the root cause of the fall the very narrow and specific fact that there was a piece of paper on the floor, for which Resident 8 was reaching when she fell. FF 38. Petitioner added two interventions to the care plan after this fall: in-servicing staff to keep the dining room free of paper/clutter and referring Resident 8 to therapy. FF 40. The first of these interventions was not new; Resident 8’s care plan already called for keeping the area free of clutter. CMS Ex. 18 at 1; P. Ex. 1 at 72-73. Under different circumstances, the therapy referral may have borne more fruit, but by the time it was given, it was too late; Resident 8’s condition had declined severely, and she died shortly thereafter. FF 41-42.

Notwithstanding these facts, Petitioner asserts that it substantially complied with 42 C.F.R. § 483.20(k)(2). Petitioner makes three arguments in support of this contention, none of which is persuasive. Petitioner also objects to testimony about Resident 8’s falls prior to the events detailed in the SOD.

Petitioner essentially argues that because it revised Resident 8’s care plan after every fall, it did not violate the regulation. P. Pre-hrg. Br. at 8-10; P. Reply at 11-13. As the analysis above shows, however, simply updating Resident 8’s care plan with some intervention after each of her falls does not equal substantial compliance. Those care plan revisions were supposed to “meaningfully respond” to Resident 8’s needs, Countryside, DAB No. 2853 at 20-21, but they fell far short of that requirement. At a minimum, Petitioner should have developed and implemented interventions that addressed Resident 8’s propensity to pick up objects generally, not just cups or dolls or papers, and her poor balance and posture. By the time Petitioner added an intervention that might have helped with these problems—the therapy referral after her April 2015 fall—Resident 8’s fall injuries had effectively confined her to a bed.

Petitioner also argues that the interventions it added to Resident 8’s care plan after the March 2014 fall were appropriate and effective (in other words, they meaningfully responded to Resident 8’s needs) because Resident 8 did not fall again for almost a year. P. Br. at 15-16, 22. Even ignoring the fall on September 14, 2014, which did not involve Resident 8’s wheelchair, this argument still fails. Just because Resident 8 did not fall out of her wheelchair for almost a year after the March 2014 fall does not mean that the interventions meaningfully responded to Resident 8’s needs following the fall. Given the pattern of deficiency that emerges when viewing Petitioner’s responses to the March

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2014, March 2015, and April 2015 falls, I find it more likely that, even if Petitioner’s care plan changes after the March 2014 fall helped Resident 8 to avoid falling out of her wheelchair, those changes were still insufficient and that it was only a matter of time before Petitioner fell again.

Petitioner further argues that the interventions suggested by CMS (e.g., a Broda chair, a Geri-chair, a tilt-in-space chair, or a regular lap buddy) constituted restraints that the regulations prohibited Petitioner from using on Resident 8 without a medical purpose. P. Br. at 4-9, 20. According to Petitioner, Resident 8 lacked a medical symptom justifying the use of a restraint. P. Br. at 8-9, 20. Even assuming Petitioner is correct, excluding these specific interventions still would have left open other possibilities that Petitioner could have explored, but did not. Petitioner could have referred Resident 8 to physical therapy sooner, when it might have done some good. Indeed, this possibility was contemplated explicitly in a pre-existing intervention on Resident 8’s care plan: “Refer to Therapy as needed.” CMS Ex. 18 at 1; P. Ex. 1 at 72-73. Petitioner also could have instituted a plan to supervise Resident 8 to ensure the other care-planned interventions were actually implemented effectively. At the least, Petitioner could have assessed—at the time, based on Resident 8’s contemporaneous condition, not after the fact when facing CMS enforcement remedies—whether to use a restraint, such as a regular lap buddy (which Petitioner had used for Resident 8 in the past in response to a fall, FF 10-12), to protect Resident 8 from another fall. Petitioner would assuredly not be doing so for disciplinary or convenience reasons, and Petitioner’s significant deficits potentially could have supported use due to medical symptoms, especially if Petitioner was pursuing other methods of helping to improve Resident 8’s chances of not falling out of her wheelchair. See 42 C.F.R. § 483.13(a). Petitioner did none of these things and continued to provide Resident 8 with a breakaway lap buddy, which was demonstrably ineffective at avoiding Resident 8 falling forward out of her wheelchair. After all, as Dr. Leslie testified, the breakaway lap buddy serves “more of a psychological barrier than a physical barrier” because the breakaway lap buddy would disengage from a wheelchair when a resident falls forward, and Resident 8 was cognitively impaired and could not be reminded not to lean forward. Tr. v. 1 at 327-330; see also FF 17. Given Resident 8’s assessed inabilities, Petitioner needed to consider the regular lap buddy.

Finally, Petitioner purports to object to references dating back years before the July 30, 2015 survey because it claims to have been in substantial compliance prior to the survey. P. Reply at 7. Petitioner complains that, at the hearing, CMS relied on “material not admitted into evidence” to go far beyond refreshing witness recollection. Id. To the extent CMS elicited testimony in this way, that testimony is part of the record, and Petitioner waived objection to that testimony by not objecting at the hearing. Furthermore, this testimony about Resident 8 is relevant background for exploring Petitioner’s noncompliance revealed by the survey. See 42 C.F.R. § 498.60(b).

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Resident 8 was a very vulnerable resident, as demonstrated by her many serious diagnoses, declining condition, and dependence on Petitioner’s staff for assistance with a variety of basic functions. FF 4, 5, 6, 32-33. Petitioner’s failure to revise her care plan in meaningful ways to address her repeated falls from her wheelchair violated 42 U.S.C. § 1395i-3(b)(2)(B) and 42 C.F.R. § 483.20(k)(2), and put her at grave risk of serious harm. That risk of harm was realized on more than one occasion, as she suffered head injuries during her March 2015 and April 2015 falls that necessitated trips to the emergency room and ultimately led to her death. FF 35-36, 38-39, 43. Therefore, I conclude that Petitioner was not in substantial compliance with 42 C.F.R. § 483.20(k)(2).

2. Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(h) (Tag F323) because it failed to take all reasonable steps to address the foreseeable risks of harm arising from Resident 8’s repeated falls from her wheelchair, which also contributed directly to her death.

Subsection 483.25(h) is part of the quality of care regulation at 42 C.F.R. § 483.25, which states that “[e]ach 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 comprehensive assessment and plan of care.” Subsection 483.25(h) imposes specific obligations upon a facility related to accident hazards and accidents, as follows: The facility must ensure that:

(1) The resident environment remains as free of accident hazards as is possible; and

(2) Each resident receives adequate supervision and assistance devices to prevent accidents.

Therefore, subsection 483.25(h)(1) requires that a facility address foreseeable risks of harm from accidents “by identifying and removing hazards, where possible, or, where the hazard is unavoidable because of other resident needs, managing the hazard by reducing the risk of accident to the extent possible.” Maine Veterans’ Home - Scarborough, DAB No. 1975 at 10 (2005) (explaining the inherent standard of care in section 483.25(h)(1)). The provisions of section 483.25(h) “come into play when there are conditions in a facility that pose a known or foreseeable risk of accidental harm.” Meridian Nursing Ctr., DAB No. 2265 at 9 (2009), aff’d sub. nom., Fal-Meridian, Inc. v. U.S. Dep’t of Health & Human Servs., 604 F.3d 445 (7th Cir. 2010). Further, subsection 483.25(h)(2) requires that a facility 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.” Briarwood Nursing Ctr., DAB No. 2115 at 11 (2007) (citing Woodstock Care Ctr. v. Thompson, 363 F.3d 583, 589 (6th Cir. 2003) (facility must take “all reasonable precautions against residents’ accidents”), aff’g Woodstock Care Ctr., DAB No. 1726 (2000)). Facilities are given “the flexibility to choose the methods” they use to provide supervision or assistive devices to prevent

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accidents, so long as the chosen methods “constitute an ‘adequate’ level of supervision” for a particular resident’s needs. Windsor Health Care Ctr., DAB No. 1902 at 5 (2003), aff’d sub. nom., Windsor Health Ctr. v. Leavitt, 127 F. App’x 843 (6th Cir. 2005).

Petitioner plainly failed to follow these requirements with respect to Resident 8. Resident 8 needed a wheelchair, but she also faced a serious and ongoing risk of harm from her propensity to fall out of her wheelchair. She in fact fell from her wheelchair on numerous occasions. As described in detail in the previous section, Petitioner’s responses to Resident 8’s most recent falls out of her wheelchair in March 2014, March 2015, and April 2015 were myopic, at best. Its assessments were perfunctory, focusing on the fact that Resident 8 was reaching for, respectively, a doll, a cup, and a piece of paper just prior to each fall, and it developed interventions based solely on those perfunctory assessments. It is significant that Resident 8’s personal physician was not involved in those assessments. Petitioner, to Resident 8’s extreme detriment, ignored the more fundamental problems causing or contributing to her falls. Thus, Petitioner fell far short of taking all reasonable steps to manage and, to the extent possible, mitigate the eminently foreseeable risk that Resident 8 would fall out of her wheelchair and thereby suffer potentially serious injury. As already noted, Resident 8 suffered serious injury and ultimately died after falling from her wheelchair. FF 38-39, 42.

The parties focus a significant amount of their time and attention on disputing whether it would have been reasonable to provide Resident 8 a special wheelchair, such as a Broda chair, Geri-chair, tilt-in-space chair, or similar device, to reduce her risk of falling. CMS Br. at 16-19; P. Br. at 4-10, 17-18; CMS Reply at 5-8. Certainly, Petitioner could have at least assessed whether a device of this type was appropriate for Resident 8 in the wake of her March 2014 or March 2015 falls. In addition, Petitioner could have taken, but did not take, a variety of other reasonable steps to mitigate the risk of harm to Resident 8. Involving her personal physician more directly in responding to her falls (by, for example, including him on Resident 8’s IDT and having him participate in her quarterly assessments and care plan reviews) is an obvious step Petitioner could and should have taken. Referring Resident 8 to physical and occupational therapy after the March 2014 and March 2015 falls is another. Resident 8’s care plans specifically contemplated providing such a referral in response to falls, FF 23-24, 31, and Petitioner even referred her to physical therapy in response to a separate fall (from her bed) in September 2014, FF 28-29. Actually discussing her falls history during her February 2015 quarterly care plan conference is yet another reasonable step Petitioner could and should have taken. See FF 34. Although one of Petitioner’s witnesses, Clinton Caudill, stated in his declaration that “[e]ach and every fall intervention was reviewed quarterly by the IDT team [sic] during quarterly care plan review . . . .” (P. Ex. 13 at 2 ¶ 11), I do not credit this testimony because this statement conflicts with the summary of the February 26, 2015 care plan conference summary (CMS Ex. 36 at 257; P. Ex. 1 at 76), and Mr. Caudill worked as a regional nurse consultant for Petitioner’s parent company (P. Ex. 13 at 1 ¶ 3) and did not even attend the February 26, 2015 care plan conference.

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In the same vein, conducting a full assessment of Resident 8 after her March 2015 fall, including reviewing the effectiveness of existing fall care plan interventions and identifying additional risk factors contributing to the fall, would have been reasonable and in compliance with Petitioner’s falls policy. FF 3b. Providing for some minimal level of supervision for Resident 8 to ensure effective implementation of the other interventions intended to reduce her falls risk also would have been a reasonable step for Petitioner to take. At no point did Petitioner seem even to contemplate supervising Resident 8, and it certainly never included supervision in her care plans. FF 24, 31. At least assessing Resident 8 contemporaneously for restraints, as Petitioner had done previously in response to a fall from her wheelchair, FF 11, would have been reasonable, too. Petitioner might have determined in the end that restraints were not called for, although previously it concluded that a regular lap buddy was an appropriate restraint to give Resident 8 following a prior fall out of her wheelchair. FF 12. Given that a manufacturer’s description of a regular lap buddy stated that it could help prevent a wheelchair occupant from leaning forward, FF 13, such a device seems like it might have been well-suited to protect Resident 8 from falling out of her wheelchair. As noted above, the breakaway version of the lap buddy only provided the illusion of a barrier, but would not save Resident 8 from falling forward out of the wheelchair. Tr. v. 1 at 329-330.

Petitioner argues that it did not violate 42 C.F.R. § 483.25(h) with respect to Resident 8 because, it asserts, “[t]here was no hazardous environment, no lack of adequate supervision and no assistance devices that were needed but not provided.” P. Br. at 17. To the contrary, Resident 8 did face a hazard in her environment—the hazard posed by her wheelchair, evidenced by the numerous times she fell out of it. As noted above, some level of supervision is one intervention Petitioner might have implemented to alleviate the risk of harm created by the hazard Resident 8 faced. Petitioner did not care plan Resident 8 for any level of supervision, much less a level that might be deemed “adequate.” FF 24, 31.

Petitioner also argues that Resident 8 needed a regular wheelchair to maintain her quality of life and reduce her risk of developing venous stasis and deep vein thrombosis and that a lap buddy, anti-tipping device, or special wheelchair of the types the surveyor and CMS suggested would have restrained her inappropriately. P. Br. at 17-18, 20. This argument misses the point. Petitioner was not necessarily required to implement any specific intervention to mitigate Resident 8’s fall risk. See Windsor Health, DAB No. 1902 at 5. However, on the facts of this case, Petitioner was required to take some additional (reasonable) steps to mitigate Resident 8’s fall risk. Even assuming that Resident 8 needed a regular wheelchair and that a regular lap buddy and anti-tipping device were inappropriate under the circumstances, Petitioner still had plenty of options from which to choose, as detailed above.

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Resident 8 faced a real risk of serious harm from her continued falls out of her wheelchair. Petitioner was well aware of this risk. Yet, Petitioner failed to take all reasonable steps to mitigate the risk, thereby violating 42 C.F.R. § 483.25(h). In no small part because of Petitioner’s failure, Resident 8 fell, suffered serious injury, and died. Consequently, I conclude that Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(h).

3. CMS’s determination that Petitioner’s noncompliance with 42 C.F.R. §§ 483.20(k)(2), 483.25(h) posed immediate jeopardy to resident health and safety from April 12, 2015 through July 29, 2015, is not clearly erroneous.

CMS asserts that Petitioner’s deficiencies constituted immediate jeopardy (at the “J” scope and severity level) to resident health and safety from April 12, 2015 through July 29, 2015. Petitioner argues that if I were to find noncompliance, such noncompliance does not constitute immediate jeopardy or, if there was any immediate jeopardy at all, it ended long before July 29, 2015.

Immediate jeopardy exists if a 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. The regulation does not require that a resident actually be harmed. Lakeport Skilled Nursing Ctr., DAB No. 2435 at 8 (2012). I must uphold CMS’s determination as to the level of a facility’s substantial noncompliance (which includes an immediate jeopardy finding) unless it is “clearly erroneous.” 42 C.F.R. § 498.60(c). The “clearly erroneous” standard imposes on facilities a heavy burden to show no immediate jeopardy and has sustained determinations of immediate jeopardy where CMS presented evidence “from which ‘[o]ne could reasonably conclude’ that immediate jeopardy exists.” See, e.g., Barbourville Nursing Home, DAB No. 1962 at 11 (2005) (quoting Florence Park Care Ctr., DAB No. 1931 at 27-28 (2004)). The burden of persuasion regarding the duration of noncompliance is also Petitioner’s. Owensboro Place & Rehab. Ctr., DAB No. 2397 at 12 (2011) (citing Kenton Healthcare, LLC, DAB No. 2186 at 24-25 (2008) and Lake Mary Health Care, DAB No. 2081 at 30 (2007)). Likewise, an SNF’s “burden of demonstrating clear error in CMS’s immediate jeopardy determination ‘extends to overcoming CMS’s determination as to how long the noncompliance remained at the immediate jeopardy level.’” Id. (quoting Azalea Court, DAB No. 2352 at 17 (2010)). CMS’s determination regarding the duration of immediate jeopardy “is presumed to be correct” unless Petitioner carries its “heavy burden to demonstrate clear error.” Brian Ctr. Health & Rehab./Goldsboro, DAB No. 2336 at 9 (2010); see also Barn Hill Care Ctr., DAB No. 1848 (2002) (“Just as CMS need not provide affirmative evidence of continuing noncompliance, it need not provide affirmative evidence that the deficiencies continued at the immediate jeopardy level; instead, the facility must demonstrate that it has taken the corrective action necessary to remove the immediate jeopardy, even if it is not yet in substantial compliance.”).

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Notably for present purposes, “[b]ecause an approved plan of correction serves as the facility’s allegation of compliance, its content may be regarded as evidence of the measures necessary to bring the SNF back into substantial compliance.” Libertyville Manor Rehab. & Healthcare Ctr., DAB No. 2849 at 14 (2018). The DAB “‘has long rejected as contrary to the goals of the [Medicare] program’ the notion that a SNF ‘can belatedly claim to have achieved substantial compliance at a date earlier than it even alleged [in its plan of correction] that it had done so . . . .’” Id. (quoting Cal Turner Extended Pavilion, DAB No. 2030 at 18 (2006)). These principles apply equally, if not with greater force, when a facility alleges it abated immediate jeopardy conditions. See Lake Mary, DAB No. 2081 at 29.

Here, CMS’s finding of immediate jeopardy is not “clearly erroneous.” As discussed in greater detail above, Petitioner’s noncompliance with 42 C.F.R. §§ 483.20(k)(2), 483.25(h) directly contributed to Resident 8’s April 12, 2015 fall and, by extension, her death. Given that Petitioner’s noncompliance relates back at least to its inadequate response to Resident 8’s March 5, 2015 fall, at a minimum, then, Petitioner’s immediate jeopardy noncompliance began on April 12, 2015. In its POC, Petitioner alleged that it removed immediate jeopardy on July 30, 2015, an allegation that the state agency and CMS accepted. I presume, then, that immediate jeopardy lasted until that date unless Petitioner has proven clear error in CMS’s determination. See Brian Ctr., DAB No. 2336 at 9.

Petitioner argues that, even assuming it did not substantially comply with 42 C.F.R. § 483.20(k)(2), 483.25(h), CMS’s immediate jeopardy finding was clearly erroneous. P. Br. at 14. In support of this argument as to 42 C.F.R. § 483.20(k)(2), Petitioner points to assessments of Resident 8 that it conducted and the interventions that it added to Resident 8’s care plan following her falls and the year between her March 2014 and March 2015 falls. Id. at 14-16. In support of this argument as to 42 C.F.R. § 483.25(h), Petitioner reiterates its position that implementing a Broda chair, Geri-chair, tilt-in-space wheelchair, traditional lap buddy, or anti-tipping device would have unduly inhibited Resident 8’s quality of life. Id. at 16-17. Petitioner’s position seems to be that, because none of these specific interventions would have been appropriate for Resident 8, any noncompliance with 42 C.F.R. § 483.25(h) was not serious enough to constitute immediate jeopardy, perhaps because Petitioner was motivated by its duty under 42 C.F.R. § 483.13(a) to forego using restraints on Resident 8 absent a medical symptom justifying restraints. See id. at 20 (arguing that Petitioner would have violated 42 C.F.R. § 483.13(a) by giving Resident 8 a traditional lap buddy because “Resident 8 had no medical symptom that would have justified the use of a lap buddy”).

Petitioner has fallen far short of carrying its heavy burden to show no immediate jeopardy existed. Petitioner could have taken numerous steps, and implemented a variety of interventions, that did not unduly restrain Resident 8, but that offered more protection from her high risk of falling and suffering harm from falls. On this record, I am not

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persuaded even that certain types of restraints, particularly the traditional lap buddy that Petitioner already had given Resident 8 once before following a fall, would have been inappropriate as additional protection, especially if Petitioner was simultaneously seeking to improve Petitioner’s stability through therapy or another intervention. Petitioner’s failure to meaningfully revise Resident 8’s care plan and take all reasonable steps to protect her from accidents not only violated its duties under 42 C.F.R. §§ 483.20(k)(2), 483.25(h), it created a substantial risk that Resident 8 would suffer serious harm or even death, a risk that unfortunately came to fruition.

In the alternative, Petitioner argues that even if immediate jeopardy existed, it ended long before July 30, 2015. P. Br. at 21-22; P. Reply at 8-11. Petitioner asserts that it “had a very thorough and effective systemic approach to falls and care plan revisions . . . in effect months before the survey.” P. Br. at 21. According to Petitioner, it implemented a systemic approach to falls by May 1, 2015, that included: capturing relevant information for each fall in an incident report, “describ[ing] the ‘whys’ that the event occurred,” diagramming “how the resident was found in relation to the room,” updating the resident’s care plan, and holding daily weekday clinical team meetings “to review any issues that arise such as falls.” Id.; see also id. at 13. Petitioner asserts that “[a] combination of care conferences, clinical meetings, Quarterly Care Plan assessments, Fall Risk Assessments, and Root Cause Analysis done for every resident after every fall” bolsters its claim that immediate jeopardy ended before July 30, 2015. Id. at 22 (emphasis in original). Petitioner also argues that because Resident 8 died on April 23, 2015, any immediate jeopardy conditions affecting her care could not have continued beyond that date. P. Br. at 23-24; P. Reply at 8.

Petitioner’s arguments about the duration of immediate jeopardy fail for two reasons. First, Petitioner’s POC, which is evidence of the measures needed to correct immediate jeopardy, see Libertyville Manor, DAB No. 2849 at 14; Lake Mary, DAB No. 2081 at 29, contained a variety of corrective measures that Petitioner did not complete until July 30, 2015, at the earliest. FF 45-46. Therefore, based on the face of the POC, it would not be clearly erroneous to conclude that immediate jeopardy continued through July 29, 2015. Petitioner argues that allegations of compliance in the POC are not “an admission of liability or a deficiency” but rather are “merely procedural requirements providers must comply with after a deficiency is alleged.” P. Reply at 8-9. The DAB has decisively rejected this reasoning. See Libertyville Manor, DAB No. 2849 at 14-15. Thus, based solely on the POC, I could find a basis for the duration of immediate jeopardy.

However, even were I to accept Petitioner’s argument that the POC was not an admission of continuing immediate jeopardy, I would still conclude that CMS did not clearly err in determining that immediate jeopardy continued through July 29, 2015. Petitioner’s inadequate responses to Resident 8’s falls revealed a fundamental problem that transcended Resident 8’s situation. Namely, Petitioner failed to consider the full context of each of Resident 8’s falls, including all factors contributing to each fall and her

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specific history of falling out of her wheelchair while trying to pick up objects generally, be it a doll, cup, piece of paper, or whatever else. Petitioner’s DON testified at the hearing that it is important to look at a resident’s fall history when choosing appropriate interventions to implement following the resident’s fall. Tr. v.2 at 254. Rather than take a global approach to see if there was a pattern to Resident 8’s falls, Petitioner looked at the narrow, specific triggering fact for a particular fall, called it the “root cause,” and developed narrow interventions to address it. Petitioner’s myopic focus in responding to Resident 8’s falls reflected a systemic problem that was likely to affect adversely any resident at risk for falls, not just Resident 8. Her death did not solve this systemic problem. Moreover, Petitioner did not solve the problem with the measures it describes and claims to have implemented by May 1, 2015, because it did not include among those measures any policy or practice to review, after every resident fall, the resident’s fall history and the full context of the fall.

By contrast, several of the steps Petitioner listed in the POC addressed this systemic problem. In the POC, Petitioner explicitly stated that it would review all residents’ accident/incident reports from the past 90 days “to include not just the individual incident/accident but a more global approach by reviewing the tracking/trending of individual resident falls . . . .” CMS Ex. 3 at 2. Further, it educated its staff to take this “more global approach” in the future so they would update resident care plans “with interventions that meet not only the individual accident/incident but also patterns identified from tracking and trending.” Id. at 4. I find it impossible to conclude that Petitioner abated immediate jeopardy prior to conducting this training, and the evidence shows that Petitioner did not complete the training until July 30, 2015. FF 46.

Petitioner’s noncompliance with 42 C.F.R. §§ 483.20(k)(2), 483.25(h) with respect to Resident 8 revealed systemic problems that were likely to cause serious harm to any resident who fell or was at risk of falling in the facility. Due to those problems, Resident 8 herself suffered serious harm and ultimately died, and the likelihood that other residents would suffer serious harm continued thereafter. Petitioner did not take action to address those systemic problems effectively until prompted by the survey, and it did not fully implement that action until July 30, 2015, at the earliest. Accordingly, I conclude that CMS did not clearly err in determining that Petitioner’s noncompliance with 42 C.F.R. §§ 483.20(k)(2), 483.25(h) posed immediate jeopardy to resident health and safety from April 12, 2015 through July 29, 2015.

4. The CMP that CMS imposed is reasonable in amount and duration.

With regard to the amount of the CMP, I examine whether a CMP is reasonable by applying the following factors: 1) the facility’s history of noncompliance (including repeated deficiencies) in general and specifically with reference to the cited deficiencies; 2) the facility’s financial condition; 3) the facility’s degree of culpability, which includes neglect, indifference, or disregard for resident care, comfort, or safety; however, the

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absence of culpability is not a mitigating factor; 4) the scope and severity of the deficiency; 5) and the relationship of the deficiency to other deficiencies resulting in noncompliance. 42 U.S.C. §§ 1320a-7a(d), 1395i-3(h)(2)(B)(ii); 42 C.F.R. §§ 488.404, 488.438(f).

The regulations specify that a CMP that is imposed against a facility on a per day basis will fall into one of two ranges of penalties. 42 C.F.R. §§ 488.408; 488.438. The upper range of a CMP, $3,050 per day to $10,000 per day, is reserved for deficiencies that pose immediate jeopardy to a facility’s residents and, in some circumstances, for repeated deficiencies. 42 C.F.R. § 488.438(a)(1)(i), (d)(2). The lower range of CMP, $50 to $3,000 per day, is reserved for deficiencies that do not pose immediate jeopardy, but either cause actual harm to residents, or cause no actual harm but have the potential for causing more than minimal harm. 42 C.F.R. § 488.438(a)(1)(ii). In assessing the reasonableness of a CMP amount, an ALJ looks at the per-day amount, rather than the total accrued CMP. See Kenton Healthcare, LLC, DAB No. 2186 at 28 (2008). The regulations leave the decision regarding the choice of remedy to CMS, and the amount of the remedy to CMS and the ALJ, requiring only that the regulatory factors at 42 C.F.R. §§ 488.438(f) and 488.404 be considered when determining the amount of a CMP within a particular range. 42 C.F.R. §§ 488.408; 488.408(g)(2); 498.3(d)(11); see also 42 C.F.R. § 488.438(e)(2) and (3); Alexandria Place, DAB No. 2245 at 27 (2009); Kenton Healthcare, LLC, DAB No. 2186 at 28-29. Unless a facility contends that a particular regulatory factor does not support the CMP amount that CMS imposed, the ALJ must sustain it. Coquina Ctr., DAB No. 1860 at 32 (2002).

CMS decided to impose a per-day CMP in this case, and I found that CMS’s determination that immediate jeopardy existed in the facility from April 12, 2015 through July 29, 2015, was not clearly erroneous. Thus, the minimum CMP I am required to sustain for that period is $3,050 per day. CMS imposed a CMP only modestly higher than this minimum amount, $3,550 per day. I conclude that this CMP is amply justified by the serious harm suffered by one resident and the serious risk of harm Petitioner’s immediate jeopardy noncompliance posed to other residents.

Petitioner does not argue specifically that any of the regulatory factors do not support the CMP amount that CMS imposed. For that reason alone, I could uphold the CMP amount that CMS imposed. Id. However, Petitioner does argue that CMS had no basis to impose an immediate jeopardy-level CMP for the full period of April 12, 2015 through July 29, 2015. P. Br. at 22-23. Petitioner premises this argument on its earlier argument that it abated immediate jeopardy before July 30, 2015. I have already addressed (and rejected) this argument for reasons explained more fully above. However, I interpret this argument also to include the implicit argument that Petitioner’s noncompliance was not severe enough to warrant a CMP above the minimum amount authorized by regulation (i.e., $3,050 per day).

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I reject this argument as well. Petitioner’s noncompliance was so severe that it led to Resident 8’s death, and it placed other residents at continuing risk of serious harm. Even viewed in isolation, the severity of Petitioner’s noncompliance would support a much greater per-day amount of CMP than $3,550. Furthermore, Petitioner did not take action sufficient to mitigate this ongoing risk for months, and only then in response to a survey. This delay reveals at least neglect of, if not indifference or outright disregard for, resident health and safety. Thus, Petitioner was culpable for its noncompliance. Petitioner has not alleged that it is unable to pay the CMP. On these facts, I conclude that the $3,550 per-day CMP that CMS imposed from April 12, 2015 through July 29, 2015, is more than reasonable in amount and duration.

VI. Conclusion

For the reasons set forth above, I affirm CMS’s determination that Petitioner was not in substantial compliance with the participation requirements at 42 C.F.R. §§ 483.20(k)(2), 483.25(h). Further, I conclude that CMS’s finding of immediate jeopardy was not clearly erroneous and that the CMP imposed, a $3,550.00 per day CMP effective April 12, 2015 through July 29, 2015, is reasonable.

• 1.The transcript of proceedings is separately paginated for each day of the hearing.  For clarity, I refer to the transcript by volume numbers; the first day of the hearing (April 25, 2017) is volume 1 (Tr. v.1); the second day of the hearing (April 26, 2017) is volume 2 (Tr. v.2), and the third day of the hearing (April 27, 2017) is volume 3 (Tr. v.3).