South Place Nursing Center, DAB CR5500 (2019)

DECISION

South Place Nursing Center (Petitioner or facility), a skilled nursing facility (SNF), routinely allowed a resident (Resident 1) to shower alone even though she had a documented risk of falling and a care plan requiring staff to assist her with showers. When showering alone one day, Resident 1 fell, suffered a severe traumatic brain injury with intracranial bleeding, entered a near-comatose state, and eventually died. The Centers for Medicare & Medicaid Services (CMS) found that Petitioner immediately jeopardized the health and safety of its residents and imposed civil money penalties (CMP) on Petitioner for violating Medicare program participation requirements and Petitioner’s own anti-neglect policy.

Petitioner does not dispute that its failure to assist Resident 1 with showers violated Medicare program participation requirements and its own anti-neglect policy and caused Resident 1’s death. Nor does it dispute that it failed to report the neglect of Resident 1 to the state. Petitioner only disputes the duration of its immediate jeopardy-level noncompliance and the reasonableness of the CMP amounts that CMS imposed.

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As I explain below, Petitioner’s serious, undisputed noncompliance, which involved the neglect and death of Resident 1, lasted far longer even than CMS alleged, thus justifying the duration of the immediate jeopardy-level CMPs. Further, the record otherwise justifies the amounts of the CMPs imposed.

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 488.1

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. 42 U.S.C. § 1395i-3(h)(1); 42 C.F.R. § 488.301. “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). “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. When a facility violates a statutory or regulatory requirement, and there is no immediate jeopardy, the facility will be subject to enforcement remedies if the violation poses 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. These surveys can be unannounced surveys that occur at least once every 15 months, or can be in response to a complaint. 42 U.S.C. § 1395i-3(g)(1)(C), ((2), (4). When the results of a survey show that an SNF is not in substantial compliance with the program participation requirements, the Secretary may impose enforcement remedies against the SNF. 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. § 1395i-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. § 1395i-

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3(h)(2)(A), (h)(2)(B)(ii)(I); 42 C.F.R. § 488.430(a). The regulations state that 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). However, CMS updated these amounts under the Federal Civil Penalties Inflation Adjustment Improvements Act of 2015, Pub. L. No. 114-74, § 701, 129 Stat. 584, 599 (2015) raising the per-day CMP range to between $103 to $6,188 per day for less serious noncompliance and $6,291 to $20,628 per day for more serious noncompliance that poses immediate jeopardy to the health and safety of residents. 45 C.F.R. § 102.3 (2016); 81 Fed. Reg. 61,538, 61,549 (Sept. 6, 2016). These inflation-adjusted amounts apply to CMPs assessed after August 1, 2016, for deficiencies occurring on or after November 2, 2015. Id. at 61,538.

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 a SNF that operates in Athens, Texas. Surveyors from the Texas Department of Aging and Disability Services (state agency) conducted an abbreviated survey of Petitioner, to investigate a complaint, which concluded on August 25, 2016. CMS Exhibit (Ex.) 1 at 20, 24; CMS Ex. 2 at 1. The state agency found that the facility was not in substantial compliance and that some of that substantial noncompliance constituted immediate jeopardy. CMS Ex. 1 at 20; CMS Ex. 2. The state agency found the following deficiencies:

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• 42 C.F.R. § 483.13(c) (Tags F224/F226) (prohibit, and develop and implement policies prohibiting, mistreatment, neglect, abuse, and misappropriation of resident property) at a scope and severity level of “K.”2
• 42 C.F.R. § 483.13(c)(1)(ii)-(iii), (c)(2)-(4) (Tag F225) (investigate and report allegations of mistreatment) at a scope and severity level of “F.”
• 42 C.F.R. § 483.25(h) (Tag F323) (accident prevention and adequate supervision) at a scope and severity level of “K.”

CMS Ex. 2.

On September 13, 2016, CMS issued an initial determination adopting the state agency survey findings and imposing termination of Petitioner’s provider agreement, effective February 25, 2017; a denial of payment for new admissions (DPNA) effective September 24, 2016; a $6,550.00 per-day CMP effective August 17, 2016 through August 25, 2016; and a $1,000 per-day CMP effective August 26, 2016 and continuing until further notice. CMS Ex. 1 at 13-15. On November 7, 2016, CMS revised its initial determination as follows: it found Petitioner returned to substantial compliance with Medicare requirements on August 29, 2016; rescinded the termination and DPNA; and revised the CMPs to include a $13,641.00 per-day CMP effective July 29, 2016 through August 17, 2016, and a $1,653.00 per-day CMP effective August 18, 2016 through August 28, 2016. CMS Ex. 1 at 3.

Petitioner filed a timely request for hearing before an ALJ to dispute the September 13, 2016 initial determination, and the DAB’s Civil Remedies Division (CRD) docketed the case under C-17-92. Following receipt of Petitioner’s hearing request, the ALJ originally

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assigned to this case issued an Acknowledgment and Initial Pre-hearing Order (Prehearing Order) that established a prehearing exchange schedule for the parties. In that order, the ALJ directed the parties to file briefs, proposed exhibits, and written direct testimony for all witnesses they wanted to present in this case.

In compliance with the Prehearing Order, CMS filed an exchange, including a prehearing brief (CMS Pre-hrg. Br.) and 21 proposed exhibits (CMS Exs. 1-21), which included the written direct testimony of two witnesses (CMS Exs. 20-21). Petitioner then timely filed an exchange, including a prehearing brief (P. Pre-hrg. Br.) and one proposed exhibit (P. Ex. 1). Petitioner also filed a motion for summary disposition, which CMS opposed. Further, Petitioner requested to cross-examine CMS’s two witnesses. Separately, Petitioner objected to CMS Exs. 2, 18, 20, and 21, while CMS did not object to any of Petitioner’s exhibits.

On November 20, 2018, CRD notified the parties that this case was transferred to me. See 42 C.F.R. § 498.44(b).

In an April 11, 2019 order, I denied Petitioner’s motion for summary disposition. In an April 23, 2019 Notice of Hearing and Ruling on Objections, I scheduled this case for a hearing to permit Petitioner to cross-examine CMS’s witnesses. I also overruled Petitioner’s evidentiary objections and admitted all of the parties’ proposed exhibits into the record, including CMS Exs. 2, 18, 20, and 21. However, I noted that I was admitting CMS Exs. 20 and 21 provisionally pending the cross-examination of those witnesses and warned that, if either witness failed to appear at the scheduled hearing, I would exclude their written direct testimony for lack of cross-examination.

Subsequently, CMS moved to withdraw CMS Exs. 20-21. By order dated July 29, 2019, I granted the motion and excluded CMS Exs. 20-21 from the record. In addition, because there remained no witness testimony in the record, I cancelled the in-person hearing and gave the parties an opportunity to submit closing briefs. See CRD Procedures §§ 16(b), 19(b); see also Prehearing Order ¶¶ 4-6. I informed the parties that, once they submitted their closing briefs, I would consider the record in the case closed and the case ready for decision on the written record. See CRD Procedures § 19(d). Neither party raised any objection to my July 29, 2019 order.

Both parties timely filed closing briefs (CMS Br. and P. Br., respectively). Each party also moved to supplement the record with an additional exhibit(s), CMS with one exhibit (CMS Ex. 22) and Petitioner with three exhibits (P. Exs. 2-4). Neither party objected to the supplemental exhibits. Therefore, I admit CMS Ex. 22 and P. Exs. 2-4 into the record.

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II. Issues

The issues are:

1. Whether Petitioner failed to comply substantially with the requirements of 42 C.F.R. § 483.13(c) (Tags F224/F226, relating to a SNF’s duty to prohibit, and develop and implement policies prohibiting, mistreatment, neglect, abuse, and misappropriation of resident property);
2. Whether Petitioner failed to comply substantially with the requirements of 42 C.F.R. § 483.13(c)(2)3 (Tag F225, relating to a SNF’s duty to investigate and report allegations of neglect);
3. 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);
4. If Petitioner was not substantially compliant with 42 C.F.R. §§ 483.13(c), and 483.25(h), whether CMS’s immediate jeopardy determination with regard to those standards was clearly erroneous; and
5. Whether the CMPs that CMS imposed are reasonable.

III. Findings of Fact

1. Petitioner is a SNF located in Athens, Texas, that participates in Medicare. CMS Ex. 1 at 3; CMS Ex. 19 at 1.
2. At all times relevant to this proceeding, Petitioner had in place an “Abuse Prohibition Management Program.” CMS Ex. 15 at 2-14. In the program’s “Introduction” section, Petitioner noted, in relevant part, that SNFs “must develop and operationalize policies and procedures . . . for the prevention, identification, investigation, and reporting of abuse, neglect or mistreatment . . . to assure that [they are] doing all that is within [their] control to . . . protect the elderly who are in their care.” Id. at 3. To advance this goal, Petitioner planned to utilize “the . . .

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policies and procedures that encompass[ed its] Abuse Prohibition Management Program.” Id.Thus, despite the title only mentioning abuse, this program also served as Petitioner’s policy for addressing and preventing resident neglect.

3. Petitioner’s anti-neglect policy defined “Neglect” as “a deprivation of life’s necessities of food, water, or shelter, or a failure of an individual to provide services, treatment, or care to a resident which causes or could cause mental or physical injury, or harm or death to the resident.” Id. at 5. In the “Screening, Training & Prevention Policy” portion of its anti-neglect policy, Petitioner stated that it would not condone resident abuse, neglect, mistreatment, or misappropriation of resident property and created procedures to prevent these matters from occurring. See id. at 6. Among those anti-neglect procedures, Petitioner included that its Quality Assurance and Assessment (QAA) Committee:

will monitor . . . and identify and correct: . . . [d]eployment of staff on each shift in sufficient numbers to meet the needs of the residents and assure that the staff assigned have knowledge of the individual residents’ care needs . . . [and t]he assessment, care planning and monitoring of residents with needs and behaviors which might lead to conflict or neglect, such as . . . residents who require heavy nursing care and/or are totally dependant [sic] on staff.

Id. at 7.

4. Resident 1, a 50-year-old woman, originally was admitted to the facility on May 5, 2014,4 and had diagnoses including type I diabetes, general malaise, urinary tract infection, chronic kidney disease, generalized muscle weakness, hypertension, and non-Alzheimer’s dementia. CMS Ex. 5 at 1; CMS Ex. 7 at 14.
5. Petitioner assessed Resident 1 as at risk for falls and instituted a care plan to address her fall risk. CMS Ex. 6 at 4.
6. Resident 1’s fall risk care plan included a variety of interventions. Id. Included among them was the following intervention, dated July 8, 2015: “Assist with showers.” Id.

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7. Petitioner last reviewed Resident 1’s fall risk care plan on December 17, 2015, and continued it with no changes.5 Id.
8. On April 6, 2016, a physician wrote that Resident 1’s “diabetes remains poorly controlled despite increasing the doses of her Levemir.” P. Ex. 3 at 2. In May and June 2016, the physician continued to note that Resident 1 did not maintain a proper diabetic diet. P. Ex. 3 at 4, 6, 9-10.
9. A June 10, 2016 Minimum Data Set Resident Assessment and Care Screening was consistent with the care plan in calling for the assistance of a staff member related to bathing/showering. CMS Ex. 7 at 12.
10. On the morning of June 20, 2016, staff found Resident 1 “totally non-responsive” and called 911. Resident 1’s blood glucose level was only 32; however, after providing Resident 1 with a GlucaGen pen and glucose gel, Resident 1 began to wake up and eat. Staff “call[ed] off the paramedics.” P. Ex. 4 at 1.
11. On the morning of June 21, 2016, staff found Resident 1 in the bathroom “unconscious with her head leaning against the handrail. Her glucose was 25.” Resident 1 returned to consciousness after administration of GlucoGen and glucose gel. P. Ex. 4 at 4; see P. Ex. 3 at 14.
12. On July 6, 2016, a physician reported that Resident 1 did not have low blood sugar during the preceding two weeks noting that the diabetes is “under better control now after changing her insulin dosing at the last visit.” P. Ex. 3 at 17-18.
13. On July 12, 2016, at or around 5:45 a.m., Resident 1 suffered an unwitnessed fall in her bathroom while getting dressed. CMS Ex. 8 at 1; P. Ex. 4 at 10. Resident 1’s glucose was 32. P. Ex. 4 at 10. Facility staff assessed Resident 1 as having no injuries from the fall and Resident 1 denied she was in pain due to the fall. CMS Ex. 8 at 1-2; P. Ex. 4 at 10.
14. By August 3, 2016, Resident 1’s physician noted that she had “another episode of hypoglycemia,” noting that “if she does not eat any snacks in the evening her sugars have been in the low 30s and she has been very lethargic.” P. Ex. 3 at 19. The physician warned that Resident 1’s “blood sugar continues to be erratic . . . because of her eating habits. I discussed with staff.” P. Ex. 3 at 20. The physician noted that “a severe hypoglycemic episode is very dangerous” and was willing to risk exacerbation of Resident 1’s coronary artery disease due to higher

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blood sugar levels in order “to prevent a severe hypoglycemic episode.” P. Ex. 3 at 20.

15. On August 17, 2016, at approximately 5:55 a.m., a licensed vocational nurse (LVN) with the initials M.O., entered one of the facility’s shower rooms and saw Resident 1 in the room showering alone. CMS Ex. 14 at 5. She inquired whether Resident 1 was supposed to be showering alone, to which the resident replied, “Yes, baby, I’m fine” and “I shower by myself.” Id.
16. After exiting the shower room, LVN M.O. asked two certified nursing assistants (CNAs), “Does [Resident 1] shower by herself?” Id. The two CNAs replied, “Yes, she does.” Id.
17. At about 6:30 a.m. that same day, Resident 1 “got up out of shower chair by her self [sic] lost balance and fell forward hitting face on floor.” CMS Ex. 13 at 2. At the time, the resident was alone in the shower room and unassisted, and her fall was unwitnessed as a result. Id. at 1, 3. The resident suffered a head injury from the fall, and, although she initially was talking to facility staff, she ultimately became unresponsive. Id.; see also CMS Ex. 17 at 1. Resident 1 had a blood glucose level of 34. CMS Ex. 13 at 3; CMS Ex. 17 at 1.
18. When Resident 1 became unresponsive, facility staff called for an ambulance, which arrived at the facility around 7:45 a.m. to transport Resident 1 for further evaluation and emergency care. CMS Ex. 13 at 3; CMS Ex. 17 at 1.
19. Resident 1 initially “was transferred to an outside facility for evaluation,” where she received “a CT scan of the head that demonstrated a large left-sided subdural hematoma with an approximately 2.3-cm shift . . . as well as some surrounding subarachnoid hemorrhage.” CMS Ex. 10 at 1-2; see also CMS Ex. 16 at 3-4, 6, 10-11. She was then transferred to East Texas Medical Center (ETMC) “for a higher level of care.” CMS Ex. 10 at 1; see also CMS Ex. 16 at 1, 4, 11.
20. After transfer to ETMC, Resident 1 was assessed by a physician to have suffered a “severe likely nonsurvivable traumatic brain injury.” CMS Ex. 10 at 3; see also CMS Ex. 11 at 1-2. A neurosurgeon evaluated her as having an “extremely poor” prognosis and “recommend[ed] palliative care with withdraw support [sic] and making [Resident 1] DNR.” CMS Ex. 10 at 3; see also CMS Ex. 11 at 4.
21. The next day, Resident 1’s condition had deteriorated; a CT scan revealed “a worsening of her head injury,” and she was “essentially comatose,” and suffering from “acute respiratory failure,” although ETMC “continu[ed] pulmonary support at that time.” CMS Ex. 11 at 1-2.

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22. On August 19, 2016, Resident 1 passed away due to her injuries. CMS Ex. 4 at 1.
23. In response to Resident 1’s fall, facility staff prepared an Incident/Accident Report and several staff members provided signed witness statements. CMS Exs. 13-14. However, Petitioner did not report the incident to the state agency.
24. On August 24, 2016, Resident 1’s brother reported the August 17, 2016 fall to the state agency. CMS Ex. 4 at 1.

IV. Conclusions of Law and Analysis

My conclusions of law are in italics and bold.

1. Petitioner was not in substantial compliance with 42 C.F.R. § 483.13(c) (Tags F224/F226) because, contrary to its anti-neglect policy, it allowed staff to care for Resident 1 who were not familiar with her care-planned need for assistance with showers, which contributed directly to the resident suffering an unassisted, unwitnessed, and ultimately fatal fall in the shower.

SNFs “must develop and implement written policies and procedures that prohibit . . . neglect . . . of residents.” 42 C.F.R. § 483.13(c). Neglect means “fail[ing] . . . to provide goods and services to avoid physical harm, mental anguish, or mental illness.” 42 C.F.R. § 488.301. Petitioner does not dispute, and the record confirms, that Petitioner did not comply substantially with this regulatory requirement.

According to her care plan, Resident 1 needed assistance with showers to mitigate her assessed risk of falls. CMS Ex. 6 at 4; see also CMS Ex. 7 at 12. Petitioner undisputedly failed to assist her with showering on August 17, 2016. CMS Ex. 13 at 1-3, CMS Ex. 14 at 5. Indeed, according to a witness statement from one of Petitioner’s own LVNs, who had interviewed two CNAs familiar with Resident 1’s normal care, Petitioner’s staff routinely allowed Resident 1 to shower alone, contrary to her care plan. CMS Ex. 14 at 5. Showering without assistance, Resident 1 fell, suffered a traumatic brain injury requiring hospitalization, and died two days later. CMS Ex. 4 at 1; CMS Ex. 10 at 1-2; CMS Ex. 11 at 1-2, 4; CMS Ex. 13 at 1-3; CMS Ex. 16 at 3-4, 6, 10-11; CMS Ex. 17 at 1. Plainly, Petitioner’s staff neglected Resident 1’s needs, as they failed to provide her with services necessary to protect her from physical harm and pain. 42 C.F.R. § 488.301; see also CMS Ex. 15 at 5 (definition of “Neglect” in Petitioner’s anti-neglect policy). The Act plainly requires SNFs to provide nursing services to the extent needed to fulfill the resident’s plan of care. 42 U.S.C. § 1395i-3(b)(4)(A)(i).

At a minimum, these facts demonstrate, as I have found, that the staff who were assigned to care for Resident 1 were unfamiliar with her care plan, including the need to assist her with showers. Under Petitioner’s anti-neglect policy, Petitioner’s QAA Committee had a

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duty to identify and correct this shortcoming to prevent direct-care staff from neglecting Resident 1. CMS Ex. 15 at 7. In addition, Petitioner’s QAA Committee had a duty to monitor, identify, and correct the assessment, care planning, and monitoring of residents, like Resident 1, who were at risk of being neglected because they needed heavy nursing care. Id. Petitioner’s QAA Committee did not discharge these duties, allowing neglectful staff, who were unfamiliar with—and did not follow—Resident 1’s care plan, to continue caring for Resident 1 until she suffered terminal injury. Consequently, I conclude that Petitioner was not in substantial compliance with 42 C.F.R. § 483.13(c).

2. Petitioner was not in substantial compliance with 42 C.F.R. § 483.13(c)(2) (Tag F225) because, despite knowing its staff neglected Resident 1 by failing to assist her with showers, Petitioner did not report that neglect to the state agency and thereby placed other residents at risk of harm from its neglectful staff.

SNFs “must ensure that all alleged violations involving . . . neglect . . . are reported immediately to the administrator of the facility and to other officials in accordance with State law through established procedures (including to the State survey and certification agency).” 42 C.F.R. § 483.13(c)(2). Texas law provides that any employee of a SNF “who has cause to believe that the physical or mental health or welfare of a resident has been or may be adversely affected by . . . neglect . . . caused by another person shall report the . . . neglect . . . .” Tex. Health & Safety Code Ann. § 260A.002(a). The employee must “make an oral report immediately on learning of the . . . neglect . . . and shall make a written report to the department not later than the fifth day after the oral report is made.” Id. § 260A.002(c). Even where an SNF reasonably should have suspected it has neglected a resident, then, pursuant to 42 C.F.R. § 483.13(c)(2), it must report to the state agency that suspicion and any investigation it undertook based on that suspicion. See Bergen Reg’l Med. Ctr., DAB No. 1832 (2002). Petitioner also does not dispute, and the record similarly confirms, that Petitioner did not comply substantially with this reporting requirement.

Petitioner’s staff neglected Resident 1 by routinely failing to assist her with showers, contrary to her care plan. Despite this obvious neglect, and even after Resident 1 suffered a life-threatening and ultimately fatal injury due to the neglect, Petitioner never reported the neglect to the state agency, contrary to its obligations under Texas and federal law. The state agency only discovered the neglect because Resident 1’s brother reported the terminal incident to the state agency a week after it happened. CMS Ex. 4 at 1. This delay in reporting exposed Petitioner’s remaining residents to the risk that Petitioner’s staff would neglect them, just as they neglected Resident 1 (e.g., by failing to follow resident care plans). As the example of Resident 1 shows, such neglect could have had lethal consequences. It is significant that the Act specifically requires state agencies to investigate allegations of neglect. 42 U.S.C. § 1395i-3(g)(1)(C). Failing to inform the state agency of the neglect, as required by state law, impeded the state

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agency’s ability to conduct a swift investigation. Therefore, Petitioner also was not in substantial compliance with 42 C.F.R. § 483.13(c)(2).

3. Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(h) (Tag F323) because it did not provide Resident 1 with the supervision it had assessed her to need while showering, which also contributed directly to the resident suffering an unassisted, unwitnessed, and ultimately fatal fall in the shower.

Congress requires SNFs to “provide services to attain or maintain the highest practicable physical, mental, and psychosocial well-being of each resident, in accordance with a written plan of care.” 42 U.S.C. § 1395i-3(b)(2). In furtherance of this mandate, the Secretary promulgated the general 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 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).

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Petitioner assessed Resident 1 as at risk for falls and determined that assisting her with showers would help mitigate that risk. CMS Ex. 6 at 4. In making this determination, Petitioner decided that assistance with showers was a reasonable intervention calculated to manage, if not eliminate, the foreseeable fall risk hazard showering posed to Resident 1. Further, during the two months before Resident 1 fell in the shower, she exhibited incidents of losing consciousness in the morning. Resident 1’s physician considered the risk of these hypoglycemic episodes to be a grave concern. But despite the care plan and recent evidence that Resident 1 was prone to passing out in the morning, Petitioner’s staff did not assist her with showers, instead allowing her to shower alone. CMS Ex. 14 at 5. LVN M.O. questioned the propriety of this behavior but relied on CNAs to tell her whether Resident 1 should be assisted in the shower. Id. Had LVN M.O. simply checked the care plan, LVN M.O. might have taken action to save Resident 1 from falling in the shower.

In failing to assist Resident 1 with showers, as her care plan called for, Petitioner failed to take all reasonable steps to ensure that she received the supervision she needed to mitigate the foreseeable risk of harm she faced from falling in the shower. See Briarwood, DAB No. 2115 at 11. Resident 1 fell, suffered a severe injury, and died as a result. Therefore, Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(h).

4. CMS’s determination that Petitioner’s noncompliance with 42 C.F.R. §§ 483.13(c) and 483.25(h) posed immediate jeopardy to resident health and safety is not clearly erroneous.

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 the DAB 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)).

Here, Petitioner does not dispute, and the record shows, that CMS’s finding of immediate jeopardy is not clearly erroneous. Petitioner’s noncompliance with 42 C.F.R. §§ 483.13(c), through its failure to implement its anti-neglect policy, and 483.25(h), through its failure to provide Resident 1 with the supervision/assistance it determined she needed to protect her from falls, directly contributed to Resident 1’s August 17, 2016 fall and, by extension, her death.

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Further, as noted earlier, Petitioner not only failed to comply with the care plan’s requirements to assist Resident 1 with showers, but had notice from the previous two months that Resident 1 was at particular risk of going unconscious due to low blood glucose levels in the morning. In both June and July 2019, Resident 1 went unconscious in the bathroom with low blood sugar, which luckily did not result in injury. In early August 2016, Resident 1’s physician became extremely concerned about these hypoglycemic incidents and took action to try to avoid another one by changing Resident 1’s insulin so that Resident 1 would generally have a higher blood sugar level. The physician did this despite the fact that this action would aggravate Resident 1’s coronary artery disease. The physician also informed staff of his concerns. Despite this, Petitioner did not take action to ensure that Resident 1 was assisted with showering.

Accordingly, I conclude that CMS did not clearly err in determining that Petitioner’s noncompliance with 42 C.F.R. §§ 483.13(c) and 483.25(h) posed immediate jeopardy to resident health and safety.

5. The CMPs that CMS imposed are reasonable in amount and duration.

In its September 13, 2016 notice of initial determination, CMS originally imposed a CMP in the upper range, $6,550.00 per day, effective August 17, 2016 through August 25, 2016, and a CMP in the lower range, $1,000.00 per day, effective August 26, 2016, and continuing until Petitioner returned to substantial compliance. CMS Ex. 1 at 14. In a November 7, 2016 letter, CMS amended the upper-range CMP to $13,641.00 per day, effective July 29, 2016 through August 17, 2016, and the lower-range CMP to $1,653.00 per day, effective August 18, 2016 through August 28, 2016, for a total CMP amount of $291,003.00. CMS Ex. 1 at 3. Thereafter, in its May 2, 2017 response to Petitioner’s request for financial hardship consideration, CMS reduced the total amount of the CMP to $203,702.10, plus interest. CMS Ex. 22 at 1. While CMS does not say so explicitly, simple math demonstrates that the amended CMP amount is 70% of the original CMP total. Stated another way, CMS reduced the total imposed CMP amount by 30% in response to Petitioner’s argument for reduction due to financial hardship. CMS Ex. 22 at 1; P. Ex. 1. Because CMS did not specifically state how it was reducing the per-day CMP amounts, I infer that this reduction applies evenly to both the upper level and lower level CMPs that CMS imposed, meaning that the modified upper-level CMP was $9,548.70 per day, and the modified lower-level CMP was $1,157.10 per day.

Petitioner challenges the reasonableness of both the amount and duration of these CMPs.

Amount. I examine whether a CMP is reasonable by applying the factors listed in 42 C.F.R. § 488.438(f): 1) the facility’s history of noncompliance; 2) the facility’s financial condition; 3) the factors specified in 42 C.F.R. § 488.404; and 4) the facility’s degree of culpability, which includes neglect, indifference, or disregard for resident care,

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comfort, or safety. See 42 U.S.C. §§ 1320a-7a(d)(2), 1395i-3(h)(2)(B)(ii)(I). The absence of culpability is not a mitigating factor. 42 C.F.R. § 488.438(f). The factors listed in 42 C.F.R. § 488.404 include: 1) the scope and severity of the deficiency; 2) the relationship of the deficiency to other deficiencies resulting in noncompliance; and 3) the facility’s prior history of noncompliance in general and specifically with reference to the cited deficiencies. See 42 U.S.C. §§ 1320a-7a(d)(1), (3), 1395i-3(h)(2)(B)(ii)(I).

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 CMPs, $6,291 per day to $20,628 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); 45 C.F.R. § 102.3 (table). The lower range of CMPs, $103 to $6,188 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); 45 C.F.R. § 102.3 (table). 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).

Rather than arguing that any of the regulatory factors do not support the CMP amounts that CMS imposed, Petitioner complains that CMS did not fully account for all those factors in determining the amount of the CMPs it imposed. P. Pre-hrg. Br. at 5-6; P. Br. at 3-4. Relatedly, Petitioner criticizes CMS’s recoupment of the CMP amount for placement in escrow. In support, Petitioner notes that, although CMS provided in its May 2, 2017 letter for a yearlong payment schedule splitting the CMP total, plus interest, into twelve roughly equal monthly payments of approximately $17,908.65, CMS in fact recouped greater than the full amount of the CMP (plus interest) in three months, including a recoupment of $96,731.13 in a single month. P. Br. at 4.

Simply put, whether CMS properly considered all regulatory factors in determining the CMP amounts to impose or correctly recouped payments due to Petitioner has no bearing on whether the CMPs are reasonable in amount. I could uphold the CMP amount solely based on Petitioner’s failure to argue that any particular regulatory factor does not support the CMP amount. Coquina Ctr., DAB No. 1860 at 32.

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But even considering the regulatory factors independently, I would conclude that the CMPs are reasonable in amount. Petitioner has a history of noncompliance, both with deficiencies identified in the present case and more generally. This case involved noncompliance, at the immediate jeopardy level, with 42 C.F.R. § 483.25(h) (Tag F323) (accident prevention and adequate supervision). In 2014 and 2015, the two years preceding the events in the present case, Petitioner was in substantial noncompliance with that requirement, on three separate occasions, at the H and G levels (i.e., actual harm to residents, but not immediate jeopardy). CMS Ex. 19 at 2. These deficiencies resulted in total CMPs of $1,300, $3,250 and $9,652.50. Id. In 2010, CMS also imposed a CMP on Petitioner of $2,600 for substantial noncompliance with 42 C.F.R. § 483.25(c)(1) (Tag 314) (Pressure Sore) at the H level. Id. at 3-4. The facility’s history alone justifies imposing CMPs that are substantially greater than the minimum, particularly in light of the facility’s erratic compliance with the quality-of-care regulation (i.e., the regulation involving accident hazards and adequate supervision). See H.R. Rep. No. 100-391(I), 100th Cong., 1st Sess. (1987) (expressing the goal of eliminating the “yo-yo” or “roller coaster” phenomenon); Florida Agency for Health Care Admin. v. Bayou Shores SNF, LLC, 2016 WL 3675462 at 19 (11th Cir. July 11, 2016); Heartland Manor at Carriage Town, DAB No. 1664 (1998).

Further, Petitioner’s actions in the present case were very culpable. Neglect of Resident 1 led directly to her fatal fall and revealed systemic issues with the care Petitioner provided to all its residents, placing them all in immediate jeopardy. As the surveyors alleged and CMS found, then, Petitioner’s noncompliance involved neglect of, if not indifference to or outright disregard for, resident care; amounted to at least a pattern of immediate jeopardy, the second highest severity level; and comprised multiple serious, interrelated regulatory violations. Petitioner’s culpability is also great because staff were ignorant of Resident 1’s care plan, which required staff to assist Resident 1 while showering. Further, for two months before the fall, Resident 1’s medical condition showed an extreme risk for hypoglycemic episodes during which Resident 1 would lose consciousness. Twice Resident 1 had lost consciousness in the bathroom without injury. Petitioner should have been on heightened alert to assist Resident 1 while showering due to Resident 1’s medical condition. Although not at the immediate jeopardy level, Petitioner also failed to recognize the neglect or report it to the state agency, which had to be apprised by a relative of the resident after a week had passed since her terminal fall.

Finally, Petitioner’s financial condition, which is the only factor on which it seems to rely in arguing for a reduction in the CMPs, is a factor that weighs against its serious noncompliance. P. Exs. 1-2. Although Petitioner’s financial condition weighs in favor of reducing the CMPs, CMS already granted a significant reduction in the CMP amount based on Petitioner’s financial condition. CMS Ex. 22. I find that any further reduction, absent specific evidence from Petitioner that such a reduction is required to avoid putting Petitioner out of business or seriously impairing resident care, is unwarranted because it

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would render the CMPs insufficient to address the severity of Petitioner’s multiple related instances of noncompliance and its culpability for that noncompliance.

Therefore, I conclude that the $9,548.70 upper-range CMP and $1,157.10 lower-range CMP imposed by CMS are reasonable in amount.

Duration. CMS does not need to show that an SNF was not in substantial compliance on each day during which a remedy remains in effect; rather, the SNF bears the burden of showing that its noncompliance was of shorter duration than alleged by CMS. 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, a 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.”).

Petitioner argues that CMS has failed to prove that Petitioner’s noncompliance started on July 29, 2016, or existed any time prior to August 17, 2016. P. Pre-hrg. Br. at 6-7; P. Br. at 4-7. In support, Petitioner observes that the allegations of immediate jeopardy-level noncompliance from July 29, 2016 through August 17, 2016, center exclusively on Resident 1’s August 17, 2016 fall in the shower while unsupervised. P. Pre-hrg. Br. at 6-7; P. Br. at 4-7.6 According to Petitioner, “[t]here is no evidence that Resident 1 allegedly showered alone on any specific date other than August 17, 2016,” undermining any basis to impose a CMP prior to that date. P. Br. at 7.

Petitioner’s argument fails for two reasons. First, it misconstrues the burden of proof; as I have explained, Petitioner has to prove that its noncompliance did not last as long as CMS claims. Owensboro Place, DAB No. 2397 at 12. Petitioner has put forth no evidence that, prior to August 17, 2016, its staff was following Resident 1’s care plan by assisting her with showers and that the incident on that date was an aberration in

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otherwise compliant care. Second, and more fundamentally, Petitioner’s argument is premised on a crabbed view of the evidence. CMS’s evidence shows that Resident 1 showered alone before August 17, 2016. As I have found, the fact that (1) two different CNAs both admitted to LVN M.O. that Resident 1 showered alone and (2) Resident 1 herself told LVN M.O. that she showered alone demonstrate that Petitioner’s staff were routinely allowing Resident 1 to shower alone and were also generally unaware of Resident 1’s care-planned needs. CMS Ex. 14 at 5. This was true even though on June 21, 2016, staff found Resident 1 in the bathroom “unconscious with her head leaning against the handrail” and, on July 12, 2016, the resident suffered an unwitnessed fall in the bathroom. CMS Ex. 8 at 1; P. Ex. 4 at 4, 10. If anything, following the July 12 fall, Petitioner’s staff should have been more familiar with Resident 1’s fall risk care plan and followed it more carefully to mitigate the possibility of another unwitnessed fall. But, they were not familiar with it and did not follow it. CMS Ex. 14 at 5. As I have found, Resident 1 showered alone with some regularity, and, although I cannot say with certainty that she showered on any particular dates, I have also found that she showered alone on numerous occasions from July 12, 2016 through August 17, 2016. Based on these facts, I conclude that Petitioner’s noncompliant care for Resident 1 began even prior to July 29, 2016. As explained earlier, that care posed immediate jeopardy both to Resident 1 and to Petitioner’s other residents, fully supporting the imposition of an upper level CMP from July 29, 2016 through August 17, 2016.

V. Conclusion

For the reasons set forth above, I sustain CMS’s determinations. I find that Petitioner was not in substantial compliance with the participation requirements at 42 C.F.R. §§ 483.13(c), (c)(2), 483.25(h); that CMS’s determination of immediate jeopardy was not clearly erroneous; and that the reduced CMPs imposed by CMS, a $9,548.70 per-day CMP effective July 29, 2016 through August 17, 2016, and a $1,157.10 per-day CMP effective August 18, 2016 through August 28, 2016, are reasonable.

• 1. All citations to the Code of Federal Regulations are to the version in effect at the time of the survey unless otherwise indicated.
• 2. Scope and severity levels are used by CMS and state survey agencies when selecting remedies. The scope and severity level is designated by letters A through L, selected by CMS or the state agency from the scope and severity matrix published in the State Operations Manual, chap. 7, § 7400.5 (Sep. 10, 2010). A scope and severity level of A, B, or C indicates a deficiency that presents no actual harm but has the potential for minimal harm, which is an insufficient basis for imposing an enforcement remedy. Facilities with deficiencies of a level no greater than C remain in substantial compliance. 42 C.F.R. § 488.301. A scope and severity level of D, E, or F indicates a deficiency that presents no actual harm, but has the potential for more than minimal harm that does not amount to immediate jeopardy. A scope and severity level of G, H, or I indicates a deficiency that involves actual harm that does not amount to immediate jeopardy. Scope and severity levels J, K, and L are deficiencies that constitute immediate jeopardy to resident health or safety. The matrix, which is based on 42 C.F.R. § 488.408, specifies which remedies are required and optional at each level based upon the frequency of the deficiency.
• 3. The state agency and CMS cited Petitioner generally with a failure to comply with Tag F225, which includes the Medicare program participation requirements at 42 C.F.R. §§ 483.13(c)(1)(ii)-(iii), (c)(2)-(4). CMS Ex. 1 at 13; CMS Ex. 2 at 11-12. However, it is clear from the statement of deficiencies (SOD) and CMS’s briefing that the focus of the citation is on Petitioner’s noncompliance with 42 C.F.R. § 483.13(c)(2). CMS Ex. 2 at 12-17; CMS Pre-hrg. Br. at 10-11. Therefore, I do not discuss further the Medicare program participation requirements at 42 C.F.R. § 483.13(c)(1)(ii)-(iii), (c)(3)-(4).
• 4. The resident was discharged to a hospital for evaluation on November 25, 2015, and readmitted to the facility on November 28, 2015. CMS Ex. 5 at 1, 6; CMS Ex. 7 at 3.
• 5. The Care Plan was printed on August 25, 2016. CMS Ex. 6 at 4. Therefore, I infer from this that the fall risk care plan remained in effect, unchanged.
• 6. Relatedly, Petitioner notes in its closing brief that, to support the CMPs imposed, CMS also relied, in its briefs, on allegations that Petitioner failed to provide Resident 1 with diabetic services. P. Br. at 5-7. I find it unnecessary to explore this issue further because the evidence relating to Petitioner’s neglect of Resident 1’s need for assistance with showers fully supports the CMPs imposed by CMS.