Better Care Inc. d/b/a The Redwoods Post Acute, DAB CR6521 (2024)

DECISION

Better Care Inc. d/b/a The Redwoods Post Acute (Petitioner or facility), a skilled nursing facility (SNF) that participates in the Medicare program, left a resident (R1) unsupervised, even though R1 had a documented risk and significant history of falls and a care plan requiring a staff member to sit with her at all times (1:1 sitter).  On April 4, 2020, the 1:1 sitter temporarily left R1 in her wheelchair unattended while the 1:1 sitter used the bathroom.  While the 1:1 sitter was in the bathroom, R1 had an unwitnessed fall from her wheelchair, landing on her back and sustaining a head wound.  R1 was transferred to the hospital where she was diagnosed with a traumatic cerebral intraparenchymal hemorrhage.  Although subsequently discharged back to Petitioner’s facility on April 7, 2020, on April 12, 2020, R1 died at Petitioner’s facility due to complications of subdural hemorrhage caused by blunt force head injury.

Based on the findings of a complaint investigation conducted by the California Department of Public Health (state agency), the Centers for Medicare & Medicaid Services (CMS) found that Petitioner had not been in substantial compliance with Medicare program participation requirements for SNFs at 42 C.F.R. § 483.25(d) relating to accident hazards and adequate supervision.  CMS agreed with the state agency that the

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deficiency resulted in actual harm to one of the facility’s residents.  CMS imposed a $12,515 per-instance civil money penalty (CMP) on Petitioner.

Petitioner disputes there was a deficiency and argues that R1’s fall was unavoidable.  Petitioner asserts that it provided adequate supervision and interventions to prevent accidents, as supported by clinical records and staff statements.  Petitioner further argues that R1’s Fall Prevention Care Plan did not require a 1:1 sitter.

As I explain below, I conclude that Petitioner was noncompliant with 42 C.F.R. § 483.25(d) because Petitioner failed to provide R1 with adequate supervision, as required by R1’s care plan, to prevent an accident.  Therefore, I affirm CMS’s determination that Petitioner was not in substantial compliance with Medicare participation requirements when it failed to properly supervise R1, which resulted in injury and death.  Further, I conclude that the CMP amount imposed was appropriate and reasonable under relevant statutory and regulatory factors.

I. Legal Framework

The Medicare program “provides basic protection against the costs of . . . related post-hospital . . . care” for individuals over the age of 65 who are eligible for Social Security retirement benefits and for individuals under 65 who meet other criteria.  42 U.S.C. § 1395c.  Post-hospital care includes extended care services provided at an SNF.  42 U.S.C. §§ 1395f(a)(2)(B), 1395x(h)-(i).

For Medicare program purposes, an SNF is an institution that is primarily engaged in providing skilled nursing care and/or rehabilitation services for its residents but is not primarily engaged in the care and treatment of mental diseases.  42 U.S.C. §§ 1395x(j), 1395i-3(a)(1).  Because an SNF is a “provider of services” in the Medicare program, each SNF that participates in the program must file a provider agreement with the Secretary of Health and Human Services (Secretary).  42 U.S.C. §§ 1395cc(a), 1395x(u).

A participating SNF must meet a variety of ongoing statutory requirements regarding how it provides services, maintains the rights of its residents, and administers its facility.  42 U.S.C. § 1395i-3(a)(3), (b)-(d).  Further, SNFs must comply with “such other requirements relating to the health, safety, and well-being of residents or relating to the physical facilities thereof as the Secretary may find necessary.”  42 U.S.C. § 1395i-3(d)(4)(B); see 42 U.S.C. § 1395i-3(c)(1)(xi), (f).  The Secretary has promulgated regulations to establish those additional requirements.  See 42 C.F.R. pt. 483, subpt. B.¹

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When an SNF fails to meet a statutory or regulatory participation requirement, then the SNF has a “deficiency.”  42 C.F.R. § 488.301; see 42 U.S.C. § 1395i-3(h)(1).  “Noncompliance” means “any deficiency that causes a facility to not be in substantial compliance.”  42 C.F.R. § 488.301; see also 42 U.S.C. § 1395i-3(h)(3).  To maintain “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.

“It is the duty and responsibility of the Secretary to assure that requirements which govern the provision of care in skilled nursing facilities . . . are adequate to protect the health, safety, welfare, and rights of residents and to promote the effective and efficient use of public monies.”  42 U.S.C. § 1395i-3(f)(1).  To do so, 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.  Standard surveys are unannounced and occur at least once every 15 months.  42 U.S.C. § 1395i-3(g)(2)(A)(i), (iii)(I).  State agencies also conduct investigations into complaints against SNFs.  42 U.S.C. § 1395i-3(g)(1)(C), (4).

When the results of a survey show that an SNF is not in substantial compliance with program participation requirements, the Secretary may impose enforcement remedies on the SNF.  42 U.S.C. § 1395i-3(h)(2); 42 C.F.R. § 488.406.  All enforcement remedies imposed on SNFs are remedial in nature because they “ensure prompt compliance with [Medicare] program requirements” and “are applied on the basis of noncompliance found during surveys conducted by CMS or by the survey agency.”  42 C.F.R. § 488.402(a)-(b).  In order to assist a facility in returning to substantial compliance quickly, SNFs must file a plan of correction with the state agency/CMS.  42 C.F.R. § 488.402(d).

When CMS selects an enforcement remedy to impose on an SNF, it determines the scope (i.e., the number of residents affected or potentially affected) and severity (i.e., the degree of harm or potential harm) for each deficiency.  See 42 C.F.R. § 488.404(a)-(b).  The highest level of severity occurs when the noncompliance immediately jeopardizes the health or safety of SNF residents.  See 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.

One enforcement remedy is a CMP.  42 U.S.C. § 1395i-3(h)(2)(B)(ii).  CMS may impose a per‑instance CMP for each instance of the SNF’s noncompliance or a per‑day CMP for the number of days an SNF is not in substantial compliance.  42 U.S.C. § 1395i‑3(h)(2)(A), (h)(2)(B)(ii)(I); 42 C.F.R. § 488.430(a).  For CMPs assessed on or after November 15, 2021, for deficiencies that occurred on or after November 2, 2015, the CMP amounts may range as follows:  $2,259 to $22,584 for per-instance CMPs; $113 to $6,774 per day for less serious noncompliance; or $6,888 to $22,584 per day for noncompliance that immediately jeopardizes the health and safety of residents.  45 C.F.R.

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§ 102.3 (2021); 86 Fed. Reg. 62,928, 62,938 (Nov. 15, 2021); see 42 C.F.R. § 488.438(a)(1) (providing original CMP amounts before statutory inflation adjustments).

If CMS imposes a CMP based on a finding of noncompliance, then the SNF may request a hearing before an administrative law judge (ALJ) to challenge CMS’s initial determination of noncompliance that led to the imposition of an enforcement remedy and/or the level of noncompliance if a successful challenge to the level would affect the range of CMP amounts imposed on the SNF.  42 U.S.C. §§ 1320a-7a(c)(2), 1395i‑3(h)(2)(B)(ii); 42 C.F.R. §§ 488.330(e)(3)(ii), 488.408(g)(1), 488.434(a)(2)(viii), 498.3(b)(13)-(14), (d)(10); see also 5 U.S.C. §§ 554, 556.  However, CMS’s choice of remedies is not reviewable.  42 C.F.R. §§ 488.438(e)(2), 488.408(g)(2), 498.3(b)(13).

If an SNF challenges the existence of a deficiency, CMS must make a prima facie case that the SNF failed to substantially comply with federal participation requirements and, if such a showing is made, the SNF must then 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).  If an SNF challenges CMS’s determination as to the level of noncompliance, CMS’s determination must be upheld unless it is clearly erroneous.  42 C.F.R. § 498.60(c)(2).

If an ALJ concludes that there was a basis for imposing a CMP on an SNF, then the SNF may dispute the amount of the CMP.  The ALJ’s review of the CMP amount is limited to considering the statutory and regulatory factors for setting a CMP amount.  42 C.F.R. § 488.438(e)(3); see 42 U.S.C. §§ 1320a-7a(d), 1395i-3(h)(2)(B)(ii)(I); 42 C.F.R. § 488.438(f).  The ALJ may not reduce a CMP to zero.  42 C.F.R. § 488.438(e)(1).

Either the SNF or CMS may request administrative review of an ALJ’s decision.  42 C.F.R. § 498.80.

II. Background and Procedural History

Petitioner is an SNF that is located in San Jose, California.  On August 18, 2021, surveyors from the state agency conducted an abbreviated survey to investigate a complaint.  CMS Ex. 1 at 1.  Based on the survey, the state agency issued a Statement of Deficiencies (SOD) documenting noncompliance with 42 C.F.R. § 483.25(d) (Tag F689) (i.e., requirement that space be free of accident hazards and that supervision and assistive devices be provided to prevent accidents) at a scope and severity level of “G” (i.e., isolated deficiency constituting actual harm that is not immediate jeopardy) related to one resident (designated as R1).  CMS Ex. 1 at 1.  The SOD summarized the basis for the deficiency as follows:

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Based on interview and record review, the facility failed to implement care plan interventions and failed to provide adequate supervision to prevent an accident for [R1] when the one-to-one sitter (1:1 sitter, staff designated to be with the resident at all times to ensure safety) went to the bathroom and did not get another staff member to stay with the resident.  This resulted in Resident 1’s fall, head injuries, and subsequent death.

CMS Ex. 1 at 1-2.

Due to this deficiency finding, on September 8, 2021, the state agency issued a notice of initial determination imposing a denial of payment for new admissions (DPNA).  The state agency noted that the DPNA would only go into effect if Petitioner did not achieve substantial compliance with Medicare participation requirements by February 14, 2022.  DAB E-File Document No. 1b.  The state agency also recommended that CMS impose a CMP.  DAB E-File Document No. 1b.

On October 11, 2021, Petitioner requested a hearing before an ALJ to dispute the state agency’s findings of noncompliance.  The Civil Remedies Division acknowledged the hearing request and issued my Standing Prehearing Order, which provided dates for the parties to file prehearing submissions.  Because CMS had not issued a notice related to the survey results, CMS requested a stay in these proceedings until CMS could issue a notice.  I granted a limited stay.

On February 14, 2022, CMS issued a notice of an initial determination adopting the state agency survey findings based on the August 18, 2021 SOD.  See CMS Ex. 2.  On February 24, 2022, CMS issued a revised initial determination.  The notice stated that Petitioner had returned to substantial compliance as of October 8, 2021, and, as a result, the DPNA did not go into effect.  However, CMS decided to impose a $12,515 per-instance CMP based on the noncompliance found during the survey.  CMS Ex. 2 at 1-2.  Finally, CMS stated that Petitioner would be prohibited from operating a Nurse Aide Training and Competency Evaluation Program (NATCEP) because the CMP imposed was more than $11,160.  CMS Ex. 2 at 4.

On March 14, 2022, CMS filed a prehearing exchange consisting of a prehearing brief and 13 proposed exhibits.  One of the proposed exhibits was written direct testimony from a witness, Dennis De Guzman, R.N. (CMS Ex. 12).  On April 18, 2022, Petitioner submitted a prehearing brief and 2 proposed exhibits.  One of the proposed exhibits was the written direct testimony from a witness, Antonette Ong Frojellin, R.N. (P. Ex. 1) and the other was the resume for that witness.  P. Ex. 2.

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On August 17, 2022, I issued a Notice of Hearing in which I scheduled a video teleconference hearing for December 6, 2022.  Because neither party objected to any of the proposed exhibits, I admitted all of the proposed exhibits into the record.²

On December 2, 2022, CMS filed a motion to withdraw its request to cross-examine Petitioner’s witness.  On December 6, 2022, I held a hearing at which Petitioner cross-examined CMS’s witness.  I gave both parties an opportunity to file post-hearing briefs and required the parties to provide, in those briefs, all arguments that they wanted me to consider when rendering this decision.  Hearing Transcript (Tr.) 24-25; February 6, 2023 Notice of Receipt of Transcript and Order Setting Post-Hearing Briefing Schedule at 1.  Both parties timely filed post-hearing briefs (CMS Br. and P. Br., respectively).

III. Issues

1) Whether Petitioner was in substantial compliance with the Medicare program requirements for SNFs at 42 C.F.R. § 483.25(d); and

2) If Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(d), whether the $12,515 per-instance CMP is reasonable and appropriate under the statutory and regulatory factors for setting a penalty amount.

IV. Findings of Fact and Conclusions of Law

My findings of fact and conclusions of law are in bold and italics.

1. On April 4, 2020, R1, a 104-year-old cognitively impaired SNF resident, suffered an unwitnessed fall when her 1:1 sitter left her alone in her wheelchair, unattended.  As a result of her fall, R1 sustained a head wound, was hospitalized, and subsequently died.  This fall occurred after R1 had fallen on four previous occasions at the facility.  It also happened in spite of R1’s Plan of Care that required staff never to leave R1 unsupervised for her safety and those of others.

R1, a 104-year-old woman, was originally admitted to Petitioner’s facility on June 1, 2018, with multiple diagnoses including:  heart failure, dementia, late-onset Alzheimer’s disease, psychosis, generalized anxiety disorder, major depressive disorder, weakness, gait and mobility abnormalities, a history of falls, osteoporosis, macular degeneration, bilateral hearing loss, and other significant medical issues.  CMS Ex. 4 at 1-3, 100-01.

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On admission, on June 1, 2018, Petitioner created a care plan with an entry for the long-term problem that R1 “is a risk for falls [related to] confusion, dementia, gait/balance problems, on [hypertension] med and diuretic, unaware of safety needs, wandering, [history of] falls prior to admission.”  CMS Ex. 4 at 21.  The care plan’s goal for R1 was:  “[R1] will not sustain serious injury through the review date.”  CMS Ex. 4 at 21.  Initial care plan interventions included ensuring R1’s call light was within reach, setting R1’s bed to the lowest position, checking on R1 “regularly,” placing bed siderails in upright position, and providing assistive devices as needed.  CMS Ex. 4 at 21.

Also on June 1, 2018, Petitioner created a care plan entry that noted that R1 was an elopement risk, was disoriented to place, had impaired safety awareness, and would wander aimlessly.  CMS Ex. 4 at 17.

On October 25, 2018, R1 had an unwitnessed fall in Petitioner’s facility, resulting in a “laceration to the left side of the head and deformed left arm with pain.”  CMS Ex. 4 at 65.  Short-term Interventions put in place after this fall included providing supervision and accompanying R1 when ambulating from her room to the front patio, and back.  This intervention was “resolved” on December 7, 2018.  CMS Ex. 4 at 65.

On April 28, 2019, R1 had another unwitnessed fall in Petitioner’s facility but sustained no injury.  CMS Ex. 4 at 67, 180.  A post-fall assessment noted that R1 fell in front of room 101 while dancing.  CMS Ex. 4 at 180.  The post-fall assessment also indicated that R1 used a walker and cane but “at times don’t want to use it.”  CMS Ex. 4 at 180.  On May 14, 2019, Petitioner added short-term interventions to R1’s care plan due to the fall including assisting R1 to the restroom promptly, evaluating R1 on the proper use of assistive devices and safety awareness, and encouraging R1 to wear glasses and use walking aids when ambulating.  CMS Ex. 4 at 67.  All of these interventions were immediately “resolved” on May 14, 2019.  CMS Ex. 4 at 67.

On September 29, 2019, R1 had a third unwitnessed fall in Petitioner’s facility and sustained a lip abrasion.  CMS Ex. 4 at 142.  Shortly before the fall, facility staff had tried to show R1 how to use her walker to ambulate outside her room but R1 “refused to listen and walked out to the hallway again.”  CMS Ex. 4 at 142.  On October 21, 2019, Petitioner added short-term care plan interventions, which included educating R1 on the use of assistive devices and safety awareness and replacing R1’s old non-skid shoes.  These interventions were immediately “resolved” on October 21, 2019.  CMS Ex. 4 at 69-70.

On October 18, 2019, R1 had a fourth fall in Petitioner’s facility that was witnessed.  CMS Ex. 4 at 71.  As a result of the fall, R1 was sent to an acute hospital for further evaluation and treatment.  CMS Ex. 4 at 72.  Interdisciplinary team (IDT) progress notes state that R1 was “completely non-compliant with the safety interventions,” would start dancing when she heard Latin music, would pace around the facility hallways to

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exhaustion, was on medications and narcotics that could increase her risk of fall, and was identified as very high risk for unavoidable falls.  CMS Ex. 4 at 184.

On October 22, 2019, R1 had an altercation with another resident.  CMS Ex. 4 at 177.  To maintain R1’s safety and the safety of others, on October 23, 2019, R1 was assigned a 1:1 sitter.  CMS Ex. 4 at 58, 179, 187.

On April 1, 2020, Petitioner’s staff completed a Minimum Data Set (MDS) assessment for R1.  The MDS indicated that the new assessment was due to R1’s “[s]ignificant change in status.”  CMS Ex. 4 at 75.  The MDS assessment notes that R1 had severe cognitive impairment, with a Brief Interview for Mental Status (BIMS) score of 3 out of 15, indicating severe impairment.  CMS Ex. 4 at 81.  In additionally, R1’s Activities of Daily Living (ADLs) required the following levels of support:

• R1 required “Extensive assistance” from staff and needed “Two+ persons physical assist” for bed mobility (i.e., “how resident moves to and from lying position, turns side to side, and positions body while in bed or alternative sleep furniture”);
• R1 had “Total dependence” on staff and needed “Two+ persons physical assist” for transfers (i.e., “how resident moves between surfaces including to and from:  bed, chair, wheelchair, standing position (excludes to/from bath/toilet)”);
• R1 required “Extensive assistance” from staff and needed “One person physical assist” for walking in room (i.e., “how resident walks between locations in his/her room”);
• R1 required “Extensive assistance” from staff and needed “One person physical assist” for locomotion on unit (i.e., “how resident moves between locations in his/her room and adjacent corridor on same floor.  If in wheelchair, self-sufficiency once in chair”);
• R1 required “Extensive assistance” from staff and needed “One person physical assist” for dressing (i.e., “how resident puts on, fastens and takes off all items of clothing, including donning/removing a prosthesis or TED hose.  Dressing includes putting on and changing pajamas and housedresses”);
• R1 required “Extensive assistance” from staff and needed “One person physical assist” from staff for eating (i.e., “how resident eats and drinks, regardless of skill”);

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• R1 required “Extensive assistance” from staff and needed “One person physical assist” from staff for toilet use (i.e., “how resident uses the toilet room, commode, bedpan, or urinal; transfers on/off toilet; cleanses self after elimination; changes pad; manages ostomy or catheter; and adjusts clothes”); and
• R1 required “Extensive assistance” from staff and needed “One person physical assist” from staff for personal hygiene (i.e., “how resident maintains personal hygiene, including combing hair, brushing teeth, shaving, applying makeup, washing/drying face and hands (excludes baths and showers)”).

CMS Ex. 4 at 89.  The MDS also indicated R1 was not steady and “only able to stabilize with staff assistance” when:  moving from seated to standing position; walking; turning around and facing the opposite direction; moving on and off the toilet; and transferring from surface-to-surface (i.e., transferring between bed and chair/ wheelchair).  CMS Ex. 4 at 90.  The MDS noted that R1 used a wheelchair.  CMS Ex. 4 at 90.

An April 1, 2020 Morse Fall Assessment indicated that R1 was high risk for falling.  A high risk for falling required only a score of 45, but R1 scored 65.  The assessment noted that R1 would overestimate, forget her limits, and had weak gait.  CMS Ex. 4 at 127.

Also on April 1, 2020, Petitioner added a new care plan entry based on R1’s confusion, impaired balance, difficulty walking, muscle weakness, and history of falls.  The care plan entry noted a “significant change (decline) in ADL.”  CMS Ex. 4 at 54.

On April 4, 2020, at 3:20 p.m., just days after the MDS assessment, R1 had an unwitnessed fall.  The CNA who was assigned as the 1:1 sitter for R1 told the state surveyor that:

Resident 1 was sitting in her wheelchair prior to the fall.  When [the CNA] needed to use the bathroom, she left Resident 1 sitting in her wheelchair in front of the nurses’ station, but [the CNA] admitted that she did not ask any particular staff person to take over supervision of Resident 1.

CMS Ex. 12 ¶ 6.

A Licensed Vocational Nurse (LVN) was assisting a different resident when a “loud slam noise was heard.”  The LVN “immediately went to assess situation,” and found R1 lying flat on the ground.  R1 was assessed as alert, and her vitals were within normal limits.  The LVN “[a]pplied pressure and a cold compress on the occipital area of head where

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bleeding was noted.”  Emergency medical personnel arrived at the facility and subsequently transported R1 to a hospital.  CMS Ex. 4 at 172; CMS Ex. 12 ¶ 8.

Hospital emergency room notes upon admission state:

104 [year-old female with history of] dementia (GCS 14 at baseline), afib (on aspirin), HTN, macular degeneration who reportedly fell after coming to stand from her wheelchair striking the back of her head on the hard floor.  Unknown LOC.  EMS reports small laceration and large hematoma to posterior scalp.  EMS also reports patient afib w RVR rates 110s-120s during transport.  Patient unable to provide history given baseline mental status.

CMS Ex. 5 at 53.  The hospital records considered R1’s fall “to be a mechanical fall based on description by SNF, patient tried to get up out of her wheelchair while sitter gone and fell.”  CMS Ex. 5 at 17.

R1’s physical exam showed a “moderate sized hematoma to right posterior scalp with small amount of dried blood to area, no active bleeding and no obvious laceration.”  CMS Ex. 5 at 55.  R1 was diagnosed with a traumatic cerebral intraparenchymal hemorrhage.  CMS Ex. 5 at 1, 13, 16, 57.  On April 7, 2020, R1 was discharged back to Petitioner’s facility.  CMS Ex. 5 at 1-8.

On April 12, 2020, R1 died at Petitioner’s facility.  The death certificate listed the immediate cause of death as complications of subdural hemorrhage due to a blunt force head injury.  CMS Ex. 6.

2. Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(d) because it did not take all reasonable steps to provide the supervision and assistance necessary to prevent a foreseeable accident and, as a result, R1 fell and was severely injured, required inpatient hospitalization, and died within a week.

The Social Security Act requires SNFs to “care for its residents in such a manner and in such an environment as will promote maintenance or enhancement of the quality of life of each resident” and “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)(1)(A), (2).  The services provided to residents “must meet professional standards of quality.”  42 U.S.C. § 1395i-3(b)(4).

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In furtherance of these stated requirements, the Secretary promulgated the “quality of care” requirements at 42 C.F.R. § 483.25.  One requirement imposes specific obligations on a facility related to supervision and accident prevention as follows:³

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.

Section 483.25(d)(1) requires a facility to 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(d) “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, section 483.25(d)(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, 590 (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).

In the present case, R1 had an unwitnessed fall on April 4, 2020, which caused injuries to R1’s head resulting in a hospital stay and ultimately her death.  CMS Ex. 4 at 74, 130, 195; CMS Ex. 5; CMS Ex. 6.  At the time of the fall, R1 was a 104-year-old female.  CMS Ex. 4 at 76.  R1 had many diagnosed conditions, including Alzheimer’s Disease

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and Non-Alzheimer’s Dementia.  CMS Ex. 4 at 2, 100-01, 131.  These basic facts are not in dispute.

However, the following are disputed matters that I must decide in this case:

1) Whether it was foreseeable that R1 was at risk for falls; and

2) Did Petitioner provide adequate supervision to prevent R1’s accident.

A. Foreseeability of R1’s Fall

The record is clear that Petitioner knew that R1 was at extreme risk for falls whenever walking unassisted.  CMS Ex. 4 at 2 (December 16, 2019 diagnosis for “History of Falling”), 21-22 (June 1, 2018 Care Plan entry that R1 had a long-term risk for falls due to confusion, dementia, gait/balance problems, unaware of safety needs, wandering, history of falls prior to admission.)  In fact, R1 fell four times at the facility prior to the April 4, 2020 fall:  October 25, 2018 (unwitnessed), April 28, 2019 (unwitnessed), September 29, 2019 (unwitnessed), and October 18, 2019 (witnessed).  CMS Ex. 4 at 65, 67, 69, 71-72.

Petitioner’s acknowledgment of R1’s significant risk of falling from the outset of her stay at the facility coupled with four falls that occurred while R1 was attempting to ambulate alone, is sufficient to find that it was foreseeable that R1 would fall again if allowed to ambulate alone.  Further, given that three of the falls resulted in injury to R1, it was foreseeable that future falls would be injurious to R1.

If Petitioner needed additional reason to be highly concerned that R1 would fall if left alone, a few days before the April 4, 2020 fall, Petitioner’s staff assessed R1 as having a score of 65 on the Morse Fall Assessment where a score of 45 was rated as a “High Risk.”  CMS Ex. 4 at 127.  Consistent with this fall assessment was an MDS assessment completed at the same time that assessed R1 as:  moderately impaired vision (CMS Ex. 4 at 80); BIMS score of 3 (CMS Ex. 4 at 81); total dependence for transferring between services with two-person assist (CMS Ex. 4 at 89); extensive assistance for walking in room and locomoting on unit with one-person assist (CMS Ex. 4 at 89); not steady with walking, moving from seated to standing position, turning around, or surface-to-surface transfers and can only stabilize with staff assistance (CMS Ex. 4 at 90); uses a wheelchair (CMS Ex. 4 at 90); and history of falls (CMS Ex. 4 at 100).  Petitioner’s staff acknowledged these troubling assessments because, also on April 1, 2020, Petitioner added a new care plan entry based on R1’s confusion, impaired balance, difficulty walking, muscle weakness, and history of falls.  The care plan entry noted a “significant change (decline) in ADL.”  CMS Ex. 4 at 54.

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Facility staff documented that R1 refused to use assistive devices when ambulating.  CMS Ex. 4 at 136, 142, 180.  Further, the state agency surveyor’s investigation also showed that facility staff knew that R1 would attempt to stand/walk unless someone would intervene.  CMS Ex. 12 ¶ 10; CMS Ex. 4 at 132.  It is significant that Petitioner did not submit any written direct testimony from the facility staff interviewed by the surveyor to refute the surveyor’s testimony.  Therefore, I credit the surveyor’s statements as to what staff conveyed to the surveyor.  See Beatrice State Developmental Ctr., DAB No. 2311 at 17, 18 (2010) (pointing out that the facility could have but did not present employee testimony that refuted the statements the surveyors claimed they made); Omni Manor Nursing Home, DAB No. 1920 at 11 (2004) (statements of facility employees to the surveyors may be admitted in an administrative proceeding and may constitute substantial evidence).

Based on the record evidence summarized above, it was clearly foreseeable that R1 would attempt to stand alone from a sitting position without the aid of assistive devices and attempt to walk if no one were around to prevent her.  Further, R1 walking unaided presented a high risk of a fall.  Given R1’s limited cognitive ability (BIMS score of 3), Petitioner knew R1 would act in accordance with her personal predilections to stand and walk when not monitored, even if trying to stand and walk unassisted was unsafe, and even if staff had repeatedly told R1 not to do it.

B. Adequate Supervision of R1

According to the state agency surveyor, Petitioner provided all necessary interventions concerning R1’s risk for falls and that, other than R1 not having a 1:1 sitter when she fell, Petitioner would have been in substantial compliance.  Tr. 17-18.  Therefore, from CMS’s perspective, the adequacy of supervision is limited to the absence of the 1:1 sitter.

Petitioner added a 1:1 sitter to R1’s care plan on October 22, 2019, after R1 had an altercation with another resident.  CMS Ex. 4 at 176-79, 186-89.  By October 24, 2019, R1 was “currently on 1:1 monitoring by staff, to redirect and ensure the safe[ty] of the resident and others.”  CMS Ex. 4 at 144.  The care plan related to the altercation indicated that “1:1 with [R1] to maintain her safety and the safety of others.”  CMS Ex. 4 at 58.

Petitioner primarily disputes that the lack of 1:1 supervision that occurred during the April 4, 2020 fall is sufficient for there to be deficiency in this case.  Petitioner argues that the 1:1 sitter was only instituted for R1’s disruptive behavior and that R1 had different interventions for fall risks.  P. Br. at 2.  Petitioner’s witness, a registered nurse, testified that R1’s fall cannot be attributed to a failure to comply with R1’s fall prevention care plan because the 1:1 sitter was not required for fall prevention.  P. Ex. 1 ¶ 7.  The witness testified that the interventions for the fall risk were progressive and had been kept updated.  P. Ex. 1 ¶¶ 8, 12, 18.  Petitioner’s witness testified that the 1:1 sitter was care planned for R1’s disruptive behavior rather than for a fall risk.  P. Ex. 1 ¶¶ 9-11.

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The witness admitted that the IDT had periodically noted the 1:1 sitter as a secondary intervention for falls but stated that this still did not mean it was a primary fall prevention method.  P. Ex. 1 ¶ 16.

R1 fell on April 4, 2020.  CMS Ex. 4 at 129.  The fall occurred when R1’s 1:1 sitter took R1 in a wheelchair close to a nurses’ station and the sitter went to use the bathroom; however, the nurses at the station attended to other tasks because they did not know R1 needed to be observed.⁴  CMS Ex. 4 at 192; Tr. 18-21.

Petitioner is correct that the fall prevention care plan does not specify that a 1:1 sitter is necessary and that the care plan concerning R1’s altercation with another resident does.  Despite this, the record shows that the facility IDT considered the 1:1 sitter to be a fall prevention intervention.  The April 12, 2020 IDT Fall Review of the April 4, 2020 fall indicated a long list of fall preventative measures that Petitioner had in place prior to the fall.  Significantly, the IDT identified “Resident is on 1:1 sitter” as an “Other Preventative Measure prior to the fall.”  CMS Ex. 4 at 130.  The IDT Fall Review also indicated that a root cause for the fall included that R1 “has behavior of getting up on her wheelchair, resident has unsteady gait/balance.”  CMS Ex. 4 at 132.  The IDT Fall Review added physical therapy as an intervention for R1.  Although this document lists the 1:1 sitter as an “other” preventative measure to stop falls, there is no reason to conclude that it was a “secondary” method as Petitioner’s witness asserted.  It appears to be as much an intervention as any listed in that IDT Fall Review.

This conclusion is consistent with an April 10, 2020 entry in the IDT Progress Notes for R1.  It acknowledges that Petitioner’s assignment of a 1:1 sitter for R1 was, in part, to prevent falls.

IDT have also identified that resident is a risk for unavoidable falls & injury. . . . Because of [R1’s] previous history of combative behaviors, IDT had implemented 1:1 sitter as an intervention with [R1] to keep her and others safe and to help prevent any falls/injuries.

CMS Ex. 4 at 191 (emphasis added).  In addition to the IDT, the state surveyor’s testimony as to the staff’s view that the sitter was needed to protect R1 from falls shows that Petitioner’s staff all believed that the 1:1 sitter was to protect R1 from falls.  CMS Ex. 12 ¶ 10.  Therefore, I reject the testimony of Petitioner’s witness that “[t]he IDT determined that a 1:1 Sitter was not necessary as a fall intervention. . . .”  P. Ex. 1 ¶ 15.

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Finally, I accept the testimony from the state surveyor, who is a registered nurse, that had the sitter not left R1 unattended, R1 might not have fallen.  CMS Ex. 12 ¶¶ 2, 11; Tr. 16-17.  In coming to this conclusion, the state surveyor explained that 1:1 coverage requires staff never to leave the resident alone, a view that Petitioner’s staff also held.  The state surveyor testified as follows:

Generally, a 1:1 sitter is a staff member who is assigned to sit one-on-one with a resident at all times to address certain safety risks.  In my professional experience, 1:1 sitters are expected to be with the assigned resident at all times. . . . [Petitioner’s] Director of Nursing confirmed in our conversation that [the CNA who was watching R1 on April 4, 2020] should have asked another staff member to take her place sitting with Resident 1 prior to leaving to use the restroom.  CMS Ex. 10 at 7-8.  Other staff members similarly confirmed that [the CNA who was watching R1 on April 4, 2020] should not have left Resident 1 without identifying a different staff member who agreed to take responsibility for sitting with Resident 1.  CMS Ex. 10 at 6, 7, 13.

CMS Ex. 12 ¶ 5.  The surveyor also testified that the 1:1 sitter was implemented for R1 to maintain her safety and the safety of others and that R1 did not fall after being assigned a 1:1 sitter until April 4, 2020.  CMS Ex. 12 ¶ 9.  As the state surveyor pointed out, R1’s fall risk was high and “contributing to her risk of falling, R1 had dementia and confusion, gait and balance problems, a history of wandering, impaired safety awareness, and a pattern of refusing to use assistive devices like her wheelchair or walker.”  CMS Ex. 12 ¶ 9.

Petitioner obviously agreed that the sitter’s actions in leaving R1 alone, even for a brief time, was improper and led to the fall, as can be seen by Petitioner’s decision to discipline the sitter for the following reasons:

Explain Specific Nature of Violation:  Not endorsing to another staff person to oversee resident on 1:1.  Then patient fell.  She was educated to call staff if leaving a patient so that p[atient] not alone.

CMS Ex. 8 at 1 (emphasis added).  Had the intervention for a 1:1 sitter been exclusively due to R1’s disruptive behavior, Petitioner would not have mentioned R1’s fall when explaining why the 1:1 sitter was being disciplined.⁵

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Whatever the care plan may have stated, the IDT and staff knew that the 1:1 sitter was serving as a necessary intervention to protect R1 from falls.  The failure to provide 1:1 coverage at all times when R1 was sitting in a wheelchair while in the hallway was inadequate supervision.

Therefore, I sustain CMS’s determination that Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(d).  R1’s fall was foreseeable, and Petitioner failed to provide adequate supervision for R1 to prevent accidents.

3. The $12,515 per-instance CMP is appropriate and reasonable under applicable statutory and regulatory factors.

CMS imposed a single per-instance CMP in the amount of $12,515 on Petitioner.  CMS Ex. 2 at 2.  When determining whether a CMP amount is appropriate, I apply 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, 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 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 sections 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 (2008).  However, unless a facility contends that a particular regulatory factor does not support the CMP amount, an ALJ must sustain it.  Coquina Ctr., DAB No. 1860 (2002).

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In the present matter, Petitioner did not provide any arguments as to the amount of the CMP that was imposed.  Petitioner’s brief concludes by only stating that “under the facts before this Tribunal the “G” Deficiency issued under Complaint number CA00692112 is not justified, it should be withdrawn.”  P. Br. at 4.  Therefore, I uphold the $12,515 CMP.  However, I briefly discuss the factors below to ensure that the amount is reasonable.

Facility’s History of Non-Compliance:  CMS argues that Petitioner’s history of noncompliance supports the CMP imposed.  CMS Br. at 18.  Petitioner was noncompliant with program requirements for surveys conducted every year from 2016 through 2019.  CMS Ex. 13.  In 2019, Petitioner had 18 “D” level deficiencies, (one of which involved the same deficiency as in this case, Tag F-689), and 3 “E” level deficiencies.  CMS Ex. 13 at 3-5.  In 2018, Petitioner had 9 “D” level deficiencies and 2 “E” level deficiencies.  CMS Ex. 13 at 2-5.  In 2017, Petitioner had 17 “D” level deficiencies, 4 “E” level deficiencies, and 1 “F” level deficiency.  CMS Ex. 13 at 2-5.  In 2016, Petitioner had 8 “D” level deficiencies, and 2 “E” level deficiencies.  CMS Ex. 13 at 2-5.  This history supports the CMP imposed.

Scope and Severity of Deficiencies and Relationship Between Deficiencies:  CMS argues that the seriousness of the offense, along with R1’s vulnerability supports the CMP.  CMS Br. at 18.  While the question of actual harm was not a matter that could be reviewed in this case, I concluded above that the record supports a finding that the deficiency resulted in harm to R1.  This provides strong support for the CMP amount imposed.

Culpability:  Petitioner is culpable in this case, and this factor supports the CMP amount.    Over a period of nearly two years, Petitioner consistently assessed R1 as a high fall risk and, in fact, assigned her a 1:1 sitter.  R1 had significant cognitive impairment and an extensive history of falls.  R1 was over 100 years old.  The record is replete with evidence to support that Petitioner was on notice that R1 was unable to comprehend and follow instructions, and that she was a danger to herself and others, and required 1:1 supervision.  Petitioner’s care plan quite reasonably called for R1 not to be left unattended.  Yet, despite all of this, Petitioner’s staff left her unattended on April 4, 2020.  Unsurprisingly, R1 then attempted to stand before falling to the ground and suffering a traumatic cerebral intraparenchymal hemorrhage.  R1 died within a week of the fall.

Financial Condition of the Facility:  Petitioner presents no evidence of its financial condition.  Therefore, this is not a factor requiring further consideration.

CMP Amount:  A per-instance CMP of $12,515 is in the middle of the penalty range for a per-instance CMP (i.e., $2,259 to $22,584).  See 45 C.F.R. § 102.3 (2021); 86 Fed. Reg. 62,928, 62,938 (Nov. 15, 2021).  Such a penalty is appropriate based on the factors considered above.

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V. Conclusion

For the reasons set forth above, I sustain CMS’s determination that Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(d) and that a $12,515 per‑instance CMP is fully supported by the relevant statutory and regulatory factors in this case.

Endnotes

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 In the Notice of Hearing, I specifically admitted CMS Exhibits 1 through 13 and Petitioner Exhibit 1 into the record because there had been no objections to these exhibits.  However, CMS did not object to Petitioner Exhibit 2; therefore, the Notice of Hearing should have stated that it was also admitted into the record.  I admit it now.

³ CMS revised part 483 regulations concerning SNF conditions of participation in 2016, including the quality of care regulation found at 42 C.F.R. § 483.25.  81 Fed. Reg. 68,688 (Oct. 4, 2016); 82 Fed. Reg. 32,256 (Jul. 13, 2017) (technical corrections).  The accident prevention regulation currently promulgated in 42 C.F.R. § 483.25(d) was formerly found in 42 C.F.R. § 483.25(h).  In assessing compliance under section 483.25(d) in this case, I consider case decisions analyzing the former section 483.25(h).

⁴ The state surveyor testified that leaving R1 alone in front of a staffed nurses’ station without getting a replacement sitter is not an equivalent intervention as having a 1:1 sitter present with R1.  Tr. 14.  Despite staff being present at the nurses’ station, none of them had been designated to watch R1 and none witnessed the fall.  Tr. 18-22.

⁵ I also conclude that it does not matter that R1’s care plan only listed a 1:1 sitter as an intervention for disruptive behavior but not for R1’s fall risk.  The introductory text to 42 C.F.R. § 483.25 makes it clear that an SNF must ensure that each resident receives treatment and care in accordance with “the comprehensive person-centered care plan.” Buena Vista Care Ctr., DAB No. 2498 at 16 (2013) (noting that the introductory text to 42 C.F.R. § 483.25 is incorporated into the accident and supervision provision now located in 42 C.F.R. § 483.25(d)).  Petitioner failed to implement the care plan provision requiring a 1:1 sitter for R1’s safety, regardless as to whether the 1:1 intervention was meant to help prevent falls.