The Rosewood Health Center, DAB CR5859 (2021)

DECISION

The Rosewood Health Center (Petitioner or “the facility”) is a skilled nursing facility (SNF) in Raleigh, North Carolina that participates in the Medicare program.  Following an extended survey in May 2018, the Centers for Medicare & Medicaid Services (CMS) determined that Petitioner was not in substantial compliance with Medicare participation requirements and that the cited deficiencies posed immediate jeopardy to resident health and safety.  CMS imposed a per-instance civil monetary penalty (PICMP) of $20,965.  For the reasons discussed below, I uphold CMS’s determinations.

I.  Background

The Social Security Act (Act) establishes requirements for SNF participation in the Medicare program and authorizes the Secretary of Health and Human Services (Secretary) to promulgate regulations implementing those statutory provisions.  See 42 U.S.C. § 1395i-3; 42 C.F.R. pts. 483 and 488.  To participate in the Medicare program, SNFs must maintain substantial compliance with program participation requirements.  In order to be in substantial compliance, deficiencies may “pose no greater risk to resident health or safety than the potential for causing minimal harm.”  42 C.F.R. § 488.301.  “Noncompliance” means “any deficiency that causes a facility to not be in substantial compliance.”  Id.

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The Secretary contracts with state agencies to conduct periodic surveys to determine whether SNFs are in substantial compliance with participation requirements.  42 U.S.C. § 1395aa(a); 42 C.F.R. §§ 488.10, 488.20.  The Act and its implementing regulations require that facilities be surveyed on average every twelve months, and more often if necessary, to ensure that identified deficiencies are corrected.  42 U.S.C. § 1395i‑3(g)(2)(A); 42 C.F.R. §§ 488.20(a), 488.308.  CMS may impose a per-day CMP for the number of days a facility is not in substantial compliance, or a PICMP for each instance of noncompliance.  42 U.S.C. § 1395i-3(h)(2)(B)(ii); 42 C.F.R. § 488.430(a). 

If CMS imposes a remedy 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).

The North Carolina Nursing Home Licensure and Certification Section of the Division of Health Service Regulation (state agency) completed an extended survey of Petitioner on May 22, 2018, at which time it determined that the facility was not in substantial compliance with Medicare program participation requirements.  CMS Ex. 1.  The state agency determined that two deficiencies, cited as 42 C.F.R. § 483.25(d)(1), (2), Tag F689, and 42 C.F.R. § 483.70,1 Tag F835, both at the “J”2 level of scope and severity, were immediate jeopardy deficiencies.3  CMS Ex. 1.  In a letter dated May 14, 2018, CMS informed Petitioner that it had not been in substantial compliance with Medicare program participation requirements and that a $20,965 CMP had been imposed.  DAB E‑File docket entry # 1a; see CMS Ex. 2 at 1.

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Petitioner, through counsel, timely requested a hearing on July 12, 2018.4   CMS filed a pre-hearing brief (CMS Br.) and 10 proposed exhibits (CMS Exs. 1-10), and Petitioner filed a pre-hearing brief (P. Br.) and 15 proposed exhibits (P. Exs. 1-15). 

I held a pre-hearing conference on July 22, 2019.  In an order dated July 23, 2019, I summarized the discussions that took place during the pre-hearing conference, to include my ruling on Petitioner’s objections to page 17 of CMS Ex. 5 (facility records pertaining to Resident # 13) and CMS Ex. 9 (surveyor notes and worksheets).5   I admitted CMS Exs. 1-10 and P. Exs. 1-15.6

During the pre-hearing conference, the parties did not dispute my framing of the issues as whether Petitioner failed to comply with the aforementioned participation requirements, and if so, whether the determination of immediate jeopardy was clearly erroneous.  After I issued the July 23, 2019 order summarizing the discussions that took place during the pre-hearing conference, Petitioner argued in a July 30, 2019 filing that it had disputed the reasonableness of the PICMP.  On August 26, 2019, I convened a video-teleconference hearing for the purpose of allowing cross-examination of several witnesses.  On the record, I explained that Petitioner had presented nothing more than conclusory statements regarding the reasonableness of the PICMP, and directed that Petitioner could not argue new bases to dispute the reasonableness of the PICMP for the first time in its post-hearing briefing.  Transcript (Tr.) at 8-12. 

After the hearing, the parties submitted post-hearing briefs and Petitioner submitted a post-hearing reply brief.  The record is closed and the case is ready for a decision on the merits.

II.  Issues

The issues presented for review are:

Whether Petitioner failed to substantially comply with the Medicare participation requirement at 42 C.F.R. § 483.25(d)(1), (2) (cited as Tag F689);

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Whether Petitioner failed to substantially comply with the Medicare participation requirement at 42 C.F.R. § 483.70 (cited as Tag F835);

Whether CMS’s finding that Petitioner’s substantial noncompliance posed immediate jeopardy to resident health and safety was clearly erroneous.

III.  Discussion7

Resident # 13

Resident # 13, a woman born in 1933, had been admitted to the facility in February 2017, on the same day she was discharged from a hospital.  CMS Ex. 5 at 1-2.  Facility records indicate that prior to her admission to the facility, Resident # 13 resided at an independent living community, The Cypress of Raleigh, that is co-located on Petitioner’s campus and of which Petitioner is a part.  P. Exs. 2 at 7; 5 at 1; see P. Ex. 9 at 1 (testimony of Eula May Hunter).  Prior to her facility admission, Resident # 13 had sustained falls with resulting injuries.  See P. Ex. 2 at 5 (reporting a history of “left ulna [fracture] secondary to fall sustained [prior to admission])”; P. Ex. 7 at 1 (physical therapy record reporting a “history significant for multiple falls with low back pain and proximal [left] shoulder [fracture] on 11/3/16 . . . .”).  Resident # 13’s admitting diagnoses included diabetes mellitus, difficulty in walking, lack of coordination, muscle weakness, unsteadiness on feet, age-related physical debility, personal history of fall, displaced fracture of the olecranon process with intraarticular extension of left ulna, and unspecified displaced fracture of the surgical neck of the left humerus.  CMS Ex. 5 at 17. 

Petitioner summarized, at the time of a February 2018 Minimum Data Set (MDS) assessment, that Resident # 13 required assistance with activities of daily living (ADLs) and that “[h]er main limiting factor to complete independence is her impaired vision” caused by diabetic retinopathy.8   CMS Ex. 5 at 15; see P. Ex. 7 at 1 (physical therapy plan of care reporting that Resident # 13 is legally blind).  Petitioner also reported that Resident # 13 is a “brittle diabetic.”  CMS Ex. 5 at 15.  Petitioner assessed that Resident # 13 had a brief interview for mental status (BIMS) score of 15/15, was alert and oriented, and could make her needs known.9   CMS Ex. 5 at 15; see CMS Ex. 5 at 4.

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During the assessment lookback period, Resident # 13 used a walker and required as much as a one-person physical assist when walking in her room, walking in the corridor, and performing transfers (i.e., changing between seated and standing positions).  CMS Ex. 5 at 9-10.

Resident # 13 had a care plan in place to address the problem that she is “at risk for falls due to generalized weakness, history of diabetes with fluctuating glucoses [sic], back pain [, and a history] of left ulna [fracture] secondary to fall sustained [prior to admission].”  CMS Ex. 5 at 16. 

Resident # 13 also had a care plan to address the problem that she “requires assistance with ADLs and believes she is capable of increased independence.”  CMS Ex. 5 at 16; P. Ex. 2 at 5; see P. Ex. 3 at 1 (Resident Summary reporting that with respect to ambulation and assistance devices, Resident # 13 receives supervised limited assistance).  Interventions included allowing Resident # 13 “to complete as much of the task as possible” but to “[a]ssist as needed,” and to “[p]rovide encouragement/supervision.”  CMS Ex. 5 at 16; P. Ex. 2 at 5.

Resident # 13 had care planning to address both difficulty hearing and visual deficits.  P. Ex. 2 at 4, 8; see P. Ex. 3 at 1 (Resident Summary reporting that Resident # 13 has impaired vision, is blind in her right eye, is “hard of hearing” in both ears, and wears hearing aids).  Interventions included maintaining eye contact while speaking to Resident # 13, speaking slowly and distinctly, positioning her close to the speaker at group activities and functions, and reviewing the daily schedule with her because she could not read the daily calendar.  P. Ex. 2 at 4, 8.

The Cypress of Raleigh has a clubhouse where its “members,” along with Petitioner’s residents, can attend events.10   See Tr. at 83-86.  The Cypress of Raleigh and Petitioner utilized a minibus to transport members and residents on and off the campus.  Tr. at 93‑94; see P. Ex. 5 at 1.  On March 19, 2018, the campus hosted a World War II lecture at its clubhouse.  See Tr. at 93.  Resident # 13 rode the minibus to travel to and from the lecture.  P. Ex. 8 at 2.  Mr. Jacek, the minibus driver, reported that although he passed

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Petitioner’s facility on his usual route, he had not previously picked up a passenger from the facility until he transported Resident # 13 on March 19, 2018.  Tr. at 93. 

During the course of her travel from the facility to the clubhouse, Resident # 13 sustained a fall.  See, e.g., CMS Ex. 6 at 3-7.  On the evening of March 19, 2018, the clubhouse concierge documented the following information in an email message that she sent to numerous recipients:

Tonight at about 7:10, [Resident # 13] was arriving for the WW II Lecture like she does every Monday evening.  One of the aides on the [minibus] was calling me from outside saying that [Resident # 13] had fallen backwards while getting off the [minibus].  I called RW and Landrye [Vakosoka] came up to check her out.  She was able to walk in and sat at [the] desk with me until RW arrived.  [Ms. Vakosoka] took all her vitals, and checked her out.  Everything checked out fine — and she had not hit her head.  She then did go down to ballroom to attend the lecture.

What [Resident # 13] explained to me was that she was sitting on the [minibus] and when it arrived at [the clubhouse], she was positioned herself on the lift (with her walker locked), then then when the lift was getting ready to go down, it jolted her backwards.  But, another member that was on the [minibus] at the same time as [Resident # 13], told me (and also told Jay) that the driver pushed the wrong button and the lift started to close rather than go down, which pushed [Resident # 13] back.

CMS Ex. 6 at 1.

Ms. Landrye Vakosoka, LPN, an employee of Petitioner, responded to the clubhouse and reported the following in an email message that evening:

Call received at [7:15 pm] from the lobby receptionist that member had a fall.  When writer arrived, [Resident # 13] was seating at the lobby in the chair talking with the receptionist and describing what has happened to her.  [Resident # 13] reported that she had fallen coming off the bus.  According to the member, when the bus stopped, the driver handed her the walker just before she comes of[f] the bus.  The lift platform boarding ramp moved up, instead of moving down and push her backward and she ended up on the floor.  [Resident # 13]

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denies hitting her head during the fall.  Assessment done and no injury a small spot on her back look light pink and member denies pain. . . . No pain or discomfort.  [Resident # 13] stated being able to ambulate and did ambulate to the ballroom without any pain and declined having someone ambulating with her.

CMS Ex. 6 at 2.

Ms. Vakosoka also authored a summary that is included in the fall scene investigation report.11   CMS Ex. 6 at 6.  Ms. Vakosoka explained:

[Resident # 13] fall at the clubhouse according to (her) [Resident # 13].  She was standing on the bus lift ramp [and] the lift ramp instead of going down it went up [and] throw member backward [and] she ended up on the floor [and] hit her back; no injury noted at the time of assessment.

CMS Ex. 6 at 6.  Despite the fact that Resident # 13’s fall occurred on a campus minibus and at least one other individual had reported being on the minibus at that time, Petitioner reported that the fall was unwitnessed and that it was a “Self-reported fall.”  CMS Ex. 6 at 4, 6; CMS Ex. 6 at 1 (email report that “another member . . . was on the [minibus] at the same time”).  The report indicates that Resident # 13’s physician was notified that same evening, and that the director of nursing/nurse manager/supervisor were notified the following morning.  CMS Ex. 6 at 7.  Petitioner selected “Equipment malfunction” as a factor observed at the time of Resident # 13’s fall, even though other pre-printed options included “Resident lost their balance” and “Resident slipped.”  CMS Ex. 6 at 4.  With respect to the root cause of the fall, Petitioner selected the option that the fall was due to “Environmental factors/items out of reach.”  CMS Ex. 6 at 7.  Petitioner stated that Resident # 13 had reported that “the bus lift ramp moved up instead of down [and] pushed [resident] to the floor.”  CMS Ex. 6 at 7.  In the section for “Falls Team Meeting Notes,” Petitioner reported that “any ambulatory member will be placed in transport wheelchair to get on lift and put in a seat on bus,” and that it would conduct “ongoing training of staff in transportation department.”  CMS Ex. 6 at 7.  Ms. Vakosoka is the sole person listed as “Staff/Witness present at/or finding resident after fall,” even though

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another “member” was on the minibus and Mr. Jacek and Ms. Hunter had been in close proximity.12   CMS Ex. 6 at 4.

Clinical notes dated between March 20 and 24, 2018, report that Resident # 13 complained of back pain and had a large bruise on her left outer upper arm.  CMS Ex. 7 at 1-3.  Petitioner was given Tramadol and Tylenol for pain.  CMS Ex. 7 at 1-3; see CMS Ex. 7 at 1 (Resident # 13’s report of “10/10” pain when she turns or moves).  A thoracic spine x-day obtained a week later reported “an age-indeterminate compression deformity of the lower thoracic spine,” and an x-ray of the sacral spine was negative for fracture.  CMS Ex. 7 at 6-7.  Resident # 13’s physician referred her for a physical therapy services, to begin on March 27, 2018, due to Resident’s “fall onto her sacrum and back,” “x-ray showing T-12 compression fracture [that] was unclear if this was a new fracture or old,” and “increased difficulty performing ADLs, transfers and gait at prior level of ability.”  P. Ex. 7 at 1. 

Petitioner updated Resident # 13’s fall risk care plan on March 19, 2018.  CMS Ex. 5 at 16.

On May 2, 2018, during the course of the survey, Petitioner re-opened its investigation of Resident # 13’s fall.  Petitioner interviewed and took a statement from Mr. Jacek that same day.  CMS Ex. 6 at 9.  Mr. Jacek reported that Resident # 13 “put her walker partially on the lift” and “was standing in the bus behind the lift (not on the lift),” and then she “apparently lost her balance and fell backwards.” 13   CMS Ex. 6 at 9.  Mr. Jacek did not report whether he had pressed any control buttons for the lift.  CMS Ex. 6 at 9.  Mr. Jacek explained that he “helped her up” and that he “know[s] now not to” lift someone who has fallen.  CMS Ex. 6 at 9; see P. Ex. 8 at 3 (“Resident # 13 started to try to get up by herself.  When she started to get up, I assisted her to her feet.”).  Mr. Jacek reported that Resident # 13 got back on the lift, he “b[r]ought it down,” and “[s]he went inside [the clubhouse].”  CMS Ex. 6 at 9. 

Petitioner also interviewed Resident # 13 on May 2, 2018.  CMS Ex. 6 at 10; see CMS Ex. 6 at 1-2.  Resident # 13 recalled that, on March 19, 2018, she did not recognize Mr.

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Jacek and believed that he was a new driver.  CMS Ex. 6 at 10; see Tr. at 93 (Mr. Jacek’s testimony that it was his first time transporting a resident from the facility).  Resident # 13 was initially reluctant to discuss the incident, explaining that “it[’]s all behind us and human error.”  CMS Ex. 6 at 10.  Resident # 13 reported that she had “waited for [Mr. Jacek] to hit the button to go down, but the lift went up instead and she fell backwards into the bus.”  CMS Ex. 6 at 10.  Resident # 13 also recalled that she was in pain following the fall and had requested a pain pill prior to bedtime that evening.  CMS Ex. 6 at 10; see CMS Ex. 7 at 1 (1:07 am clinical note on March 20, 2018, documenting that Resident # 13 was given Tramadol after she requested, “What ever I can have for this pain.”).  Resident # 13 did not recall whether she used the lift when she returned from the clubhouse to the facility.  CMS Ex. 6 at 10; see P. Ex. 8 at 4 (Mr. Jacek’s testimony that Resident # 13 disembarked using the lift).  Resident # 13 reiterated that the accident was “just human error” and expressed a desire to move past this incident.  CMS Ex. 6 at 10.

On May 2, 2018, Petitioner interviewed Ms. Hunter, a private duty CNA who was in close proximity to the minibus at the time of Resident # 13’s fall.  CMS Ex. 6 at 11.  Ms. Hunter explained that she saw Resident # 13 when she “was holding on to her walker” and “was not on the lift.”  CMS Ex. 6 at 11.  After Ms. Hunter “heard a noise,” both she and Mr. Jacek boarded the minibus to investigate what had happened.  CMS Ex. 6 at 11.  Ms. Hunter reported that Mr. Jacek “helped her up,” and then Resident # 13 “walked towards the Clubhouse.”  CMS Ex. 6 at 11.  Ms. Hunter asked the concierge to call Petitioner.  CMS Ex. 6 at 11.  In written direct testimony submitted several months later, Ms. Hunter recalled new details, to include that she “did not observe the lift move from its position at the bus floor level” and that “[t]here were no lights flashing or sirens sounding on or before Resident # 13 fell.”  P. Ex. 9 at 2. 

Petitioner submitted evidence that the minibus had been inspected annually pursuant to Department of Transportation requirements at 49 C.F.R. pt. 396.  P. Ex. 14.  The inspection reports do not document annual inspections of the passenger lift.  P. Ex. 14; see 49 C.F.R. § 396.11(a)(1) (listing the inspection elements of service brakes, parking brake, steering mechanism, lighting devices and reflectors, tires, horn, windshield wipers, rear vision mirrors, wheels and rims, and emergency equipment).  Petitioner submitted a document from The Truck Stop, dated May 2, 2018, stating the following:  “Wheelchair lift assembly fully operational.”  P. Ex. 14 at 2. 

1. Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(d)(1), (2) because it did not maintain an environment as free of accident hazards as possible and failed to provide adequate supervision and assistance devices to protect Resident # 13 from foreseeable risks of harm.

2. The facility was not in substantial compliance with 42 C.F.R. § 483.70 because it was not governed in a manner that enabled it to use its

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resources effectively to attain or maintain the highest practicable physical, mental, and psychosocial well-being of its residents.

3. Petitioner has not submitted evidence showing that CMS’s determination of immediate jeopardy was clearly erroneous.

Subsection 483.25(d) is part of the quality of care regulation at 42 C.F.R. § 483.25, which states that “[q]uality of care is a fundamental principle that applies to all treatment and care provided to facility residents.”  42 C.F.R. § 483.25.  Subsection 483.25(d) 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.

42 C.F.R. § 483.25(d)(1), (2).

The Departmental Appeals Board (DAB) has held that subsection 483.25(d)(1)14 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)); see The Bridge at Rockwood, DAB No. 2954 at 10 (2019) (“The correct question is whether the facility did what it reasonably could to ensure that all residents received supervision needed to ‘mitigate foreseeable risks of harm’ based on what it knew about the residents, their care needs, and the conditions in the facility.”).  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 10 (2009), aff’d sub nom. Fal-Meridian, Inc. v. U.S. Dep’t of Health & Human Servs.,604 F.3d 445 (7th Cir. 2010).  The DAB has held that subsection 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

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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 assistance 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). 

Pursuant to 42 C.F.R. § 483.70, a facility must be governed in a manner that enables it to use its resources effectively and efficiently to attain or maintain the highest practicable physical, mental, and psychosocial well-being of each resident.  A finding of substantial noncompliance in the facility’s administration may derive from findings of substantial noncompliance in other areas.  The DAB has explained:  

[W]here a facility has been shown to be so out of compliance with program requirements that its residents have been placed in immediate jeopardy, the facility was not administered in a manner that used its resources effectively to attain the highest practicable physical, mental, and psychosocial well-being of each resident. 

Asbury Ctr. at Johnson City, DAB No. 1815 at 11 (2002); see Stone Cty. Nursing & Rehab. Ctr., DAB No. 2276 at 15-16 (2009). 

Resident # 13 was injured when she fell on March 19, 2018, while traveling via a minibus from the facility to a clubhouse.  See CMS Ex. 7 at 1 (reporting complaints of back pain and a large bruise on the left outer arm, with 10/10 pain with movement).  Although an x‑ray reported a previously undiagnosed T-12 compression fracture, this injury is not definitively linked to the March 19, 2018 fall.15  CMS Ex. 7 at 6.  Nonetheless, the circumstances surrounding Resident # 13’s use of the minibus created a likelihood of serious injury, harm, impairment, or death, for reasons including:

• Petitioner permitted Resident # 13, who had impaired vision, unsteadiness on her feet, difficulty walking, and lack of coordination, and who had required as much as a one-person assist with transfers and with walking in her room and on the corridor, to independently travel

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via a minibus to attend an event and walk “unassisted onto the lift” of the minibus.  See CMS Ex. 5 at 9, 15, 17; P. Ex. 8 at 2.

• The minibus driver, who had not previously transported a facility resident, was unaware that he was transporting SNF residents.  Tr. at 83-85, 93.
• Even though the minibus driver did not witness Resident # 13 fall, he immediately assisted Resident # 13 to her feet and used the lift to disembark Resident # 13 from the minibus.  CMS Ex. 6 at 9; P. Ex. 8 at 2-3.

• The lift manufacturer cautions that the operator should read the operator’s manual prior to operating the lift, and that the failure to do so may result in serious bodily injury.  CMS Ex. 4 at 1.

• Despite clear instructions in the lift operator’s manual, the driver did not instruct Resident # 13 to grip the handrails of the lift; rather, before he exited the minibus himself, the driver handed Resident # 13 her walker to use while on the lift.  CMS Exs. 4 at 1, 4; 6 at 2; 8 at 3. 

• Resident # 13 reported to both the clubhouse concierge and nursing staff that she had fallen because the lift platform had moved up instead of down, yet Petitioner did not interview the driver or inspect the lift, and instead allowed the minibus and lift to remain in service that evening.  CMS Ex. 6 at 1-2; P. Ex. 8 at 3-4.

• An unidentified individual on the minibus, described as a “member,” reported that the minibus driver “pushed the wrong button and the lift started to close rather than go down.”  However, Petitioner neither identified nor interviewed this individual.  CMS Ex. 6 at 1.

• Petitioner’s March 2018 investigation report documented that Resident # 13’s fall was related to an “equipment malfunction,” and the “Fall Summary” in Petitioner’s investigation report stated that the lift moved up instead of down and “threw” Resident # 13 backward.  CMS Ex. 6 at 4, 6.  Even though the lift manufacturer instructs to “[d]iscontinue lift use immediately if any lift component does not operate properly,” and warns that “[f]ailure to do so may result in serious bodily injury and/or property damage,” Petitioner did not follow the instruction that it contact the manufacturer to arrange an inspection by “an authorized service technician.”  CMS Ex. 4 at 5.  Rather, Petitioner continued to

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operate the minibus that evening and relied on only its facilities director to inspect the lift the following day.  CMS Ex. 4 at 5-6; P. Ex. 8 at 3-4.

• The minibus driver did not notify his supervisor, the facilities director, that a passenger had fallen during transport; to the contrary, the facilities supervisor contacted the minibus driver the next day.  P. Ex. 8 at 4.

To summarize, even though Petitioner was aware that Resident # 13 was at risk for falls, required assistance with ADLs, and could not always independently walk and transfer, it allowed Resident # 13 to travel via its minibus without providing any staff support, such as a CNA.  CMS Ex. 5 at 9, 14, 16.  The campus minibus driver, who was “not quite sure” whether people who lived at Petitioner’s facility were nursing home residents, then picked up Resident # 13, without knowledge that she required assistance with ADLs.  See Tr. at 85, 93.  Neither the driver nor any staff member was on the minibus to assist Resident # 13 when she boarded the lift platform, and the driver did not direct Resident # 13 to follow the manufacturer’s instruction to grip the lift handrails.  CMS Ex. 4 at 4; P. Ex. 8 at 2.  Rather, Resident # 13 supported herself with her walker, meaning that a resident with known “unsteadiness on [her] feet” was not supported by a fixed object.  CMS Exs. 5 at 1; 6 at 9 (driver’s statement that Resident # 13 “put her walker partially on the lift”); 6 at 10 (Resident # 13’s statement that she “stood up and rolled her walker out on to the lift and locked her brakes.”).

After Resident # 13 fell, the driver immediately proceeded to assist Resident # 13 to her feet and used the lift to disembark her, even though he had been trained to call for assistance before moving a passenger with a potential injury.  CMS Ex. 6 at 9 (Driver’s statement, “I helped her up.  ([I] know now not to)”); P. Ex. 15 at 1 (Mr. Wocial’s testimony that prior to March 2018, all drivers received training that “any resident with a potential injury should not be moved until they are assessed by a nurse.”).16   Resident

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# 13 informed staff that she had fallen because the ramp moved in an unexpected direction, and another passenger, who was neither identified nor interviewed by Petitioner, reported to the concierge that the driver “pushed the wrong button.”  CMS Ex. 6 at 1-2, 7.  Nonetheless, the driver continued to operate the lift that evening, including to board and disembark Resident # 13.  CMS Ex. 6 at 9 (reporting, after Resident # 13 fell, that “[s]he proceeded to get on the lift and I brought it down.”); P. Ex. 8 at 4 (“She also exited the minibus when we arrived at The Rosewood using the lift without any issue or problem.”).  Although Petitioner’s initial investigation reported the possibility of an equipment malfunction and that Resident # 13 had been “thrown” by the lift, Petitioner’s facilities director inspected the lift the following day and did not contact the manufacturer to arrange for an inspection.17  P. Ex. 14 at 2-3; see CMS Ex. 4 at 5 (“If the outer barrier, inner roll stop, handrails, or any other lift component does not operate as outlined in this manual, discontinue lift use immediately and contact The Braun Corporation sales representative in your area . . . [who] will direct you to an authorized service technician who will inspect your lift.”). 

While the cause of Resident # 13’s fall has not definitively been established, the evidence supports that Petitioner, at least for some period of time, had either initially determined, or at least had not ruled out, that Resident # 13’s fall was related to an equipment malfunction and/or operator error.  CMS Ex. 6 at 4, 6, 7.  Yet, Petitioner did not immediately inspect the lift, nor did it instruct the driver to take the lift out of service while it investigated whether Resident # 13’s fall was caused by equipment malfunction and/or operator error.  See CMS Exs. 4 at 2 (directing that standees should grip handrails); 6 at 1‑2 (witness statements alleging the ramp did not move in the expected direction); 6 at 12 (statement that Resident # 13’s walker was partially on the lift); P. Ex. 8 at 2 (driver’s testimony that Resident # 13 supported herself with her walker while using the lift).  The contemporaneous evidence available on the evening of March 19, 2018, reports only equipment malfunction and/or operator error as the likely factors that caused Resident # 13’s fall; the minibus driver did not notify his supervisor, and no one directed that the minibus be taken out of service that evening.  See P. Ex. 8 at 4 (“The

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next day, on March 20, 2018, Mr. Pete Wocial called me and asked about Resident # 13’s fall.”). 

This series of missteps evidences a failure to maintain an environment as free of accident hazards as possible and to provide the supervision and assistance devices necessary to prevent an accident involving a potentially dangerous piece of mobility equipment.  Not only did Petitioner allow a resident with a history of falls and a documented need for assistance with walking and transfers to travel on its minibus and use the lift without assistance, but it operated the lift in contravention of the manufacturer’s instructions.  See CMS Ex. 4 at 4 (directing that standees “grip both handrails (if able) when on platform.”).  And then after Resident # 13 fell, the driver assisted her to her feet, disembarked her with the lift, and continued to operate the lift that evening, even though the contemporaneous initial reports indicated that Resident # 13 had fallen because the lift did not move in the expected direction.  See CMS Ex. 4 at 5 (directing lift owner to “discontinue lift use immediately” and contact the manufacturer so that an authorized service technician can inspect the lift).  Petitioner failed to comply with 42 C.F.R. § 483.25(d)(1), (2) when it did not ensure that the resident environment remained as free of accident hazards as possible and failed to provide the supervision and assistance devices necessary to prevent foreseeable accidents.

Petitioner argues that any noncompliance with 42 C.F.R. § 483.25(d)(1), (2) did not cause immediate jeopardy to resident health and safety.  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.  Preliminarily, I note that although the parties addressed the scope and severity of this deficiency in their arguments, it is unclear whether this matter is properly for consideration.  The regulations authorize an ALJ to review CMS’s scope and severity findings (which includes a finding of immediate jeopardy) only if a successful challenge would affect:  (1) the range of the CMP amounts that CMS could collect; or (2) a finding of substandard quality of care that results in the loss of approval of a facility’s nurse aide training program (NATCEP).  42 C.F.R. § 498.3(b)(14), (d)(10)(i)-(ii); NMS Healthcare of Hagerstown, DAB No. 2603 at 6-7 (2014).  Unlike per-day CMPs, under the regulations, there is only a single monetary range for a per‑instance CMP regardless of whether or not immediate jeopardy is present, and therefore, the immediate jeopardy finding does not affect the penalty range.  42 C.F.R. §§ 488.408, 488.438(a)(2).  The evidence does not indicate, nor does Petitioner argue, that it had a NATCEP prior to the citation of this deficiency.  See Request for Hearing (not referencing a current NATCEP); P. Br. (arguing that it would be prohibited from conducting a NATCEP, but not claiming that it lost approval for a current NATCEP).

Because CMS does not dispute that the immediate jeopardy determination is subject to review, I address this issue, assuming arguendo,that Petitioner had lost approval for a NATCEP.  I must uphold CMS’s determination as to the level of a facility’s substantial

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noncompliance (which includes an immediate jeopardy finding) unless it is “clearly erroneous.”  42 C.F.R. § 498.60(c).  The DAB directs that the “clearly erroneous” standard imposes on a facility a heavy burden to show no immediate jeopardy and has sustained determinations of immediate jeopardy where CMS presented evidence “from which ‘[o]ne could reasonably conclude’ that immediate jeopardy exists.”  See, e.g., Barbourville Nursing Home, DAB No. 1962 at 11 (2005) (citing Florence Park Care Ctr., DAB No. 1931 at 27-28 (2004)).

Petitioner has not shown that the immediate jeopardy determination was clearly erroneous.  Resident # 13 was injured when she fell; she may have sustained a serious injury (i.e., a T-12 compression fracture), but regardless of whether she sustained a fracture to her spine, the constellation of circumstances undoubtedly presented a likelihood for serious injury.  Not only was Resident # 13, a visually impaired resident with a history of falls resulting in fractures and who ordinarily required assistance with ADLs, expected to travel to another building on the campus without any staff assistance, but she was not instructed to grip the lift’s handrails.  After Resident # 13 fell, Petitioner’s driver assisted her to her feet, rather than contacting Petitioner to assess her for potential injury.  And even though Resident # 13 and another unidentified witness reported that Resident # 13 fell (or had even been thrown) because the lift did not move in the intended direction, the driver continued to operate the lift without the facility having investigated the potential for operator error or equipment malfunction. 

The potential for serious injury if a passenger falls from a lift platform cannot be underestimated; in fact, the manufacturer cautions that “serious bodily injury” may result when the procedures in the operator’s manual are not followed or when a lift continues to be used when any component does not operate correctly.  CMS Ex. 4 at 4-5.  Petitioner placed a resident with unsteadiness, visual impairment, and a history of previous falls, who ordinarily required assistance with ADLs, at significant risk for serious harm when it allowed her to traverse the campus without assistance and use a minibus lift in a manner inconsistent with the manufacturer’s guidance.  Resident # 13 fortunately fell backwards into the passenger area of the minibus; had she fallen while faced in a different direction, she could have fallen backwards off the lift platform while it was in an elevated position.  Petitioner’s failures in the aftermath of Resident # 13’s fall, to include assisting her to her feet, not requesting Petitioner send assistance to the minibus, immediately using the lift for her disembarkment, and using the lift in connection with her return travel to the facility, collectively posed significant threats to serious bodily injury.  See CMS Ex. 4 at 4-5.

Finally, I note that Petitioner’s failures are substantially due to administrative failures.  The facility’s administration failed to maintain a resident environment as free of accident hazards as possible and failed to make sure its residents received the supervision and assistance devices to prevent accidents.  See 42 C.F.R. § 483.25(d)(1), (2).  The facility

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provided a resident activity at a location outside of the facility, yet did not take the necessary steps to ensure that Resident # 13 could safely travel to and from this activity, just as it would do if it had held the activity inside of the facility.  Petitioner’s administration is responsible for making sure that it is adequately staffed, and the administration is also responsible for making sure that the facility has the means and devices to keep residents free of foreseeable risks.  Administrative failures include the unaccompanied travel of a resident with prior falls who ordinarily received assistance with ADLs, the driver’s failure to follow facility policy and the lift operating instructions, and Petitioner’s failure to take steps in the immediate aftermath of Resident # 13’s fall to protect her safety.  The facility did not substantially comply with 42 C.F.R. § 483.70, which requires that it be governed in a manner that enables it to use its resources effectively and efficiently to attain or maintain the highest practicable physical, mental, and psychosocial well-being of each resident. 

4. Petitioner did not offer a basis for its assertion that a $20,965 PICMP is an unreasonable enforcement remedy.

I preliminarily note that Petitioner has not offered any arguments or evidence why the PICMP is unreasonable.  Other than bald conclusory statements, Petitioner has not offered arguments or evidence supporting the unreasonableness of the CMP.  See Request for Hearing at 3 (listing the regulatory factors and vaguely stating that “the amount of the CMP . . . is unreasonable” because CMS and/or the state agency “did not take, or improperly took, into account” those factors); P. Br. at 28-29 (conclusory sentence in the final paragraph of the brief requesting “this Tribunal find that the determination of Immediate Jeopardy is clearly erroneous, determine that the $20,965 CMP is unreasonable and therefore reverse the imposed remedies”).  Petitioner has not submitted evidence to support its assertion that the PICMP is unreasonable, such as documentation  that it lacks the resources to pay the PICMP.

If a facility is not in substantial compliance with program requirements, CMS has the authority to impose one or more of the enforcement remedies listed in 42 C.F.R. § 488.406, including a PICMP.  In determining whether the per-instance CMP amount imposed against Petitioner is reasonable, I apply the factors listed in 42 C.F.R. § 488.438(f).  42 C.F.R. § 488.438(e)(3).  These factors include:  (1) the facility’s history of noncompliance; (2) the facility’s financial condition; (3) the factors specified at 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.  42 C.F.R. § 488.438(f).  The absence of culpability is not a mitigating factor.  Id.  The factors at 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.

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I consider whether the evidence supports a finding that the amount of a CMP is at a level reasonably related to an effort to produce corrective action by a provider with the kind of deficiencies found, and in light of the above factors.  I am neither bound to defer to CMS’s factual assertions nor free to make a wholly independent choice of remedies without regard for CMS’s discretion.  See, e.g., Barn Hill Care Ctr., DAB No. 1848 at 21 (2002).  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).  Petitioner has not argued that any particular regulatory factor(s) does not support the PICMP.

At the time of the survey, the baseline PICMP range was from $1,000 to $10,000 prior to the annual adjustment for inflation.  42 C.F.R. § 488.438(a)(2).  With inflation adjustment, the PICMP range at the time of the survey was $2,097 to $20,965.  42 C.F.R. § 488.438(a)(2); 45 C.F.R. § 102.3; 82 Fed. Reg. 9174, 9182 (Feb. 3, 2017) (setting 2017 inflation adjustments).  CMS imposed an adjusted PICMP of $20,965 for the noncompliance with 42 C.F.R. §§ 483.25(d)(1), (2) and 483.70, which is the maximum PICMP. 

In the absence of any argument why a $20,965 PICMP is an unreasonable enforcement remedy for two significant deficiencies in which a resident was injured and Petitioner continued to operate a lift without both inspecting the platform lift and investigating the circumstances of Resident # 13’s fall, there is no apparent basis to find the PICMP unreasonable.  In fact, the immediate jeopardy condition that began on March 19, 2018, continued through May 2, 2018, at which time Petitioner implemented additional corrective actions during the survey.  See CMS Ex. 6 at 8 (May 2, 2018 action plan requiring, inter alia, a CNA to accompany residents during transit and to conduct safety observations of drivers, with any necessary retraining).  Petitioner’s noncompliance was serious, and Petitioner has made no showing that a PICMP of $20,965, which is within the allowable PICMP range, is unreasonable.  

IV.  Conclusion

For the foregoing reasons, I conclude that Petitioner was not in substantial compliance with Medicare participation requirements at 42 C.F.R. §§ 483.25(d)(1), (2) and 483.70.  To the extent I may review the findings of immediate jeopardy, I uphold those determinations.  A $20,965 PICMP is a reasonable enforcement remedy.

1. Petitioner erroneously references a deficiency involving 42 C.F.R. § 483.75 in its briefing.  See Petitioner’s Brief (P. Br.) at 23; Petitioner’s Post-Hearing Brief (P. Post‑Hrg. Br.) at 1, 9.
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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.  Pub. 100-7, State Operations Manual (SOM), ch. 7, § 7400.5.1 (Factors That Must be Considered When Selecting Remedies), “Assessment Factors Used to Determine the Seriousness of Deficiencies Matrix” (table) (Rev. 63, effective Sept. 10, 2010 (applicable at the time of the survey at issue)); see SOM, ch. 7, § 7400.3.1 (Matrix for Scope & Severity) (Rev. 185, effective Nov. 16, 2018) (current version)); see also 42 C.F.R. § 488.408.  A scope and severity level of “J” indicates an isolated instance of immediate jeopardy to resident health or safety.  SOM, ch. 7, § 7400.5.1 (Rev. 63, effective Sept. 10, 2010).
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3. As relevant here, 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.
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4. This case was reassigned to me on March 8, 2019.
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5. In my July 23, 2019 order, I also rejected Petitioner’s baseless allegation that CMS or its counsel engaged in sanctionable misconduct.  With respect to the evidence that was the subject of Petitioner’s objections, it was unnecessary to rely on either document in this decision.
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6. I provisionally admitted the testimony of witnesses who had submitted direct testimony.  Because the parties did not request cross-examination of several witnesses, I admitted this written testimony.  See CMS Ex. 10; P. Exs. 1, 4, 15.
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7. Findings of fact and conclusions of law are in bold and italics.
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8. Resident # 13 informed the surveyor that “she was totally blind in her right eye due to a hemorrhage 15 years ago.”  CMS Ex. 1 at 17.
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9. A BIMS score of 15 indicates that the subject is cognitively intact.  See Long‑Term Care Facility Resident Assessment Instrument (RAI) 3.0 User’s Manual, Ch. 3 (Overview to the Item-by-Item Guide to the MDS 3.0), § C0500 (Summary Score) at C-14, https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/NursingHomeQualityInits/Downloads/MDS-30-RAI-Manual-V113.pdf (last visited April 19, 2021).
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10. At the hearing, Petitioner’s witnesses provided limited information in response to questioning about the campus.  Tr. at 84 (testimony of Gregory Jacek, discussing the difference between Petitioner and the Cypress of Raleigh, “One is like the, I guess, medical ward and the other one is for the residents that live there.”); Tr. at 97-98 (testimony of Eula Mae Hunter that Cypress of Raleigh “members” live in “cottages” and “condos”).
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11. Ms. Vakosoka did not report the date and time she completed the report, nor did she sign the report.  CMS Ex. 6 at 7.  Other individuals signed the report on March 22, 2018.  CMS Ex. 6 at 7.
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12. Contemporaneous reporting does not document that Mr. Jacek, Ms. Hunter, or the unidentified member had been interviewed or asked to provide a written statement.  See CMS Ex. 6.  Petitioner interviewed both Mr. Jacek and Ms. Hunter six weeks later on May 2, 2018, at which time both Mr. Jacek and Ms. Hunter signed written statements.  CMS Ex. 6 at 9, 11.  Although facilities director Peter Wocial testified that he interviewed Mr. Jacek by telephone on March 20, 2018, the record does not contain any contemporaneous notes memorializing that interview.  P. Ex. 15 at 2.
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13. In his written direct testimony, Mr. Jacek reported for the first time that he did not press any control buttons and the lift had not moved.  P. Ex. 8 at 2.
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14. The DAB referenced section 483.25(h)(1); that section was redesignated as section 483.25(d)(1) pursuant to regulatory revisions that became effective November 28, 2016.  81 Fed. Reg. 68,688, 68,828 (Table 1) (Oct. 4, 2016).
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15. An x-ray showed a compression deformity of the lower thoracic spine; however, the finding was “age-indeterminate,” and therefore, that radiological finding cannot be attributed to Resident # 13’s March 19, 2018 fall.  CMS Ex. 7 at 6; see P. Ex. 1 at 2 (reporting that the x-ray showed “compression fractures as either old or of indeterminate age”); but see P. Ex. 7 at 1 (order of physical therapy services to address “balance and gait deficits related to fall with possible T12 compression fracture”).
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16. Petitioner’s attempt to blame its driver’s failure to follow protocol on a purported refusal of care by Resident # 13 is unsupported by credible evidence.  P. Post‑Hrg. Br. at 7-9.  The contemporaneous evidence indicates that Resident # 13 was fully cooperative, and the records pre-dating the survey lack any reference to Resident # 13 refusing care.  In fact, Resident # 13 has expressed a reluctance to dwell on the incident and has been understanding that human error can happen.  CMS Ex. 6 at 10 (Resident # 13’s statement, “I wish everyone would just put this behind them because it was an accident.”).  It was not until after the survey that Petitioner assembled reports that Resident # 13 was somehow not cooperative and refused care.  Mr. Jacek testified that he “suggested [Resident # 13] be checked out by a nurse.”  P. Ex. 8 at 3.  Taking Mr. Jacek at his word, a declination of a “suggestion” to remain on the bus is not a refusal of care, especially considering that Resident # 13 waited to be assessed after she entered the clubhouse.  CMS Ex. 6 at 1-2.  And to the extent Ms. Hunter followed Resident # 13 off the bus and “told [her] to stop,” but she nonetheless “kept walking,” the record does not indicate that Ms. Hunter, a private duty CNA, effectively communicated with Resident # 13, who is both “legally blind” and “hard of hearing.”  P. Ex. 9 at 2; see CMS Ex. 6 at 1-2.  There is no probative evidence that Resident # 13 was uncooperative or refused care, and to the contrary, she waited for nursing staff to arrive at the clubhouse and cooperated with the assessment.  CMS Ex. 6 at 1-2, 4-7.
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17. Although the facilities supervisor testified that an alarm will sound if weight is placed on the lift’s pressure plate, Mr. Jacek reported that Resident # 13 “put her walker partially on the lift.”  P. Ex. 15 at 2; see CMS Ex. 6 at 9.  Mr. Wocial did not address the circumstance described by Mr. Jacek involving the placement of a walker, rather than the standee, on the lift, to include addressing whether the lift, if in motion, could strike the resident’s walker or cause it to move.  P. Ex. 15 at 2; see CMS Ex. 6 at 9.
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