Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Civil Remedies Division
Broadway By The Sea,
Centers for Medicare & Medicaid Services.
Docket No. C-19-731
Decision No. CR5925
Broadway By The Sea (Petitioner or facility), a skilled nursing facility (SNF), left a resident (Resident 1) unsupervised while toileting, even though she had a documented risk and significant history of falls and a care plan requiring staff to provide close supervision, including while toileting. On October 2, 2018, a certified nurse assistant (CNA) assisted Resident 1 to her toilet, briefly left Resident 1 unattended, and Resident 1 attempted to rise unassisted from the toilet, fell, and fractured her left hip. She was taken to an acute care inpatient hospital for evaluation and surgical repair of the fracture. Immediately before surgery, Resident 1 went into cardiac arrest and died shortly thereafter
Based on the findings of an investigation by state surveyors, the Centers for Medicare & Medicaid Services (CMS) concluded that Petitioner had an isolated deficiency of the Medicare participation requirement for SNFs at 42 C.F.R. § 483.25(d) (accidents), which constituted immediate jeopardy to residents. CMS imposed a $7,350 per instance civil money penalty (CMP) on Petitioner.
Petitioner disputes there was a deficiency and argues that the fall for Resident 1 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 the CMP imposed was not reasonable.
As explained below, I affirm CMS’s determination that Petitioner was in substantial noncompliance with Medicare participation requirements when it failed to properly supervise Resident 1, which resulted in injury and death to Resident 1. Further, I conclude that the CMP imposed in this matter is appropriate.
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). Further, a participating SNF must meet a variety of ongoing requirements related to how it provides services, maintains the rights of its residents, and administers its facility. 42 U.S.C. § 1395i-3(a)(3), (b)-(d); 42 C.F.R. pt. 483, subpt. B.1
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.
Broadly, noncompliance that subjects an SNF to enforcement remedies is divided into two levels. One level is comprised of deficiencies that immediately jeopardize the health or safety of residents and the other level is composed of deficiencies that do not.
42 U.S.C. § 1395i-3(h)(1). “Immediate jeopardy” exists when “the provider’s noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident.” 42 C.F.R. § 488.301.
The Secretary contracts with state agencies to conduct surveys to determine whether SNFs are in substantial compliance. 42 U.S.C. §§ 1395aa(a), 1395i-3(g); 42 C.F.R. § 488.10. These surveys can be unannounced surveys that occur at least once every 15 months or can be in response to a complaint. 42 U.S.C. § 1395i-3(g). 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. 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);2 see also 42 U.S.C. § 1395i-3(h)(2)(B)(ii)(III)(bb).
One such 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 an 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 February 3, 2017, and for deficiencies that occurred after November 2, 2015, the CMP amounts may range as follows: $2,140 to $21,393 for per-instance CMPs; $107 to $6,418 per day for less serious noncompliance; or $6,525 to $21,393 per day for more serious noncompliance that poses immediate jeopardy to the health and safety of residents. 45 C.F.R. § 102.3 (2019); 83 Fed. Reg. 51,369, 51,369-90 (Oct. 11, 2018); 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 substantial 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 this occurs, 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 Departmental Appeals Board (DAB) review of an ALJ’s decision. 42 C.F.R. § 498.80.
II. Background and Procedural History
Petitioner is an SNF that operates in Long Beach, California. Surveyors from the California Department of Public Health (state agency) conducted a complaint survey of Petitioner’s facility, which concluded on December 12, 2018. CMS Ex. 1 at 1; CMS Exs. 22, 24, 25, 28. The state agency subsequently issued a Statement of Deficiencies indicating the facility was not in substantial compliance with three Medicare program participation requirements for SNFs. CMS Ex. 1. Most significantly, the Statement of Deficiencies found substantial noncompliance with 42 C.F.R. § 483.25(d) (Tag F689) (i.e., free of accident hazards/supervision and assistive devices to prevent accidents) at a scope and severity level of “J” (i.e., isolated deficiency constituting immediate jeopardy to resident health and safety) related to one resident (Resident 1). CMS Ex. 1 at 11-21. Petitioner filed a plan of correction with Los Angeles County’s public health agency, which was accepted on January 2, 2019. CMS Ex. 1 at 1.
On February 27, 2019, CMS issued an initial determination adopting the state agency survey findings and imposing a $7,350 per-instance CMP under 42 C.F.R. § 488.430 for the substantial noncompliance identified under Tag F689 (i.e., 42 C.F.R. § 483.25(d)).
CMS Ex. 22 at 1-2. In that determination, CMS found that the state agency documented immediate jeopardy to resident health and safety on October 18, 2018, which was abated on October 19, 2018. CMS Ex. 22 at 1.
Petitioner requested a hearing before an ALJ to dispute the initial determination. P. Ex. 1. In response, the Civil Remedies Division acknowledged receipt of the hearing request and issued my Standing Prehearing Order (Order). In the Order, I directed the parties to file briefs, proposed exhibits, and written direct testimony for all witnesses they wanted to present in this case.
In compliance with the Order, CMS filed an exchange, including a prehearing brief (CMS Br.) and 29 proposed exhibits (CMS Exs. 1-29), which included declarations from two proposed witnesses (CMS Exs. 24-25). Petitioner timely filed an exchange consisting of a prehearing brief (P. Br.) and four proposed exhibits (P. Exs. 1 4). Petitioner did not offer testimony from any witnesses. Petitioner also filed a request to cross-examine CMS’s two witnesses and objections to CMS’s proposed exhibits. CMS filed a reply and objections to Petitioner’s prehearing exchange.
On January 6, 2021, I issued a Notice of Hearing (Notice) in which I scheduled a video teleconference hearing for May 24, 2021. For the reasons stated in the Notice, I dismissed portions of Petitioner’s hearing request relating to a deficiency that did not serve as a basis for the CMP in this case. Notice at 1-2. Also, I admitted into evidence CMS Exhibits 1 through 6, 15 through 19, and 21 through 29, as well as Petitioner’s Exhibits 1 through 4. As explained in the Notice, I excluded CMS Exhibits 7 through 14 and 20. Notice at 2-3.
On April 9, 2021, Petitioner filed a motion to withdraw its request to cross-examine CMS’s witnesses and requested that I render a decision on the written record. I granted Petitioner’s motion and now issue this decision based on the written record in this case. 42 C.F.R. § 498.66.
1) Whether Petitioner was in substantial compliance with the Medicare requirements for skilled nursing facilities at 42 C.F.R. § 483.25(d)(1), (2) (Tag F689).
2) If Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(d)(1), (2) (Tag F689), whether a $7,350 per-instance CMP is appropriate under the statutory and regulatory factors in 42 U.S.C. § 1320a-7a(d) and 42 C.F.R. § 488.438(f).
IV. Findings of Fact and Conclusions of Law
My findings of fact and conclusions of law are in bold and italics.
1. On October 2, 2018, Resident 1, a cognitively impaired SNF resident, suffered a witnessed fall while toileting with assistance of one CNA that resulted in a left hip fracture requiring inpatient hospitalization and surgical repair. The fall occurred when Resident 1 attempted to stand unassisted while the CNA had turned to shut off a wheelchair alarm. The CNA instructed Resident 1 not to attempt to stand without assistance. This fall came after a long history of falls at the facility and despite multiple interventions in the Plan of Care to instruct staff not to leave Resident 1 unsupervised while toileting and despite multiple instances where Resident 1 demonstrated an inability to comprehend and follow staff instructions not to attempt to move without staff assistance.
Resident 1, a 74-year-old woman, originally was admitted to the facility on January 8, 2016, with multiple diagnoses, including severe sepsis without septic shock, urinary tract infection, difficulty in walking, muscle weakness, and dysphagia. CMS Ex. 3 at 1. A Minimum Data Set (MDS) assessment, dated July 2, 2018, reflects that Resident 1 was also diagnosed with anemia, hypertension, peripheral vascular disease, diabetes mellitus, Alzheimer’s Disease, Cerebrovascular Accident (CVA), Transient Ischemic Attack, or Stroke, depression, and other diagnoses including unspecified dementia. CMS Ex. 3 at 19 20. The MDS assessment documents that Resident 1 had moderate cognitive impairment, with Brief Interview for Mental Status (BIMS) summary score 9.3 CMS Ex. 3 at 7; CMS Ex. 24 ¶ 8. A facility Advance Directives Preference document, dated March 6, 2016, indicates that Resident 1 was “not [able] to understand his/her diagnosis, prognosis, and treatment options” and that Petitioner was to contact Resident 1’s daughter to assist in decision making. CMS Ex. 3 at 49. Resident 1 was also obese. CMS Ex. 3 at 97; CMS Ex. 24 ¶¶ 9, 14.
From at least May 16, 2016 through October 2, 2018, Petitioner’s staff regularly assessed Resident 1 as a “HIGH RISK” for falls. CMS Ex. 3 at 62 67, 68. The care plan goal for Resident 1’s fall assessment was unchanged during that time: “Will be free from fall occurrences in a day and injuries through x 90 days.” CMS Ex. 3 at 68. Despite this, Resident 1’s clinical records indicate that she fell or was observed on the floor on nine occasions in little more than one year: July 17, 2017 (documented July 26, 2017), September 4, 2017, September 26, 2017, December 14, 2017, December 30, 2017, June 6, 2018, August 2, 2018, August 19, 2018, and October 2, 2018. CMS Ex. 3 at 69, 75, 81, 88, 94, 100, 106, 112, 117; see CMS Ex. 3 at 50-61 (MD order for “Falling Star” program, nurse notes, assessments, and reviews on witnessed and other falls); CMS Ex. 3 at 62 67 (18 Fall Risk Evaluations from April 16, 2016, through October 2, 2018, document Resident 1 at high risk for falls); CMS Br. at 8 10.
Petitioner had in place a “Fall Risk Assessment” and related policies, which included resident fall risk assessments by physician and staff for fall prevention, interventions as part of resident care plans, post fall assessments, and staff training. CMS Ex. 16 at 36-45. Petitioner’s “Fall Risk Assessment” policy requires monitoring and documenting subsequent falls and resident response to interventions put into place and intended to reduce falls or fall risk. The policy provides: “If the resident continues to fall, staff will re-evaluate the situation and whether it is appropriate to continue or change current interventions.” CMS Ex. 16 at 37. If the attending physician and staff conclude that a resident has “irreversible risk factors,” they will “document the basis for conclusions that specific irreversible factors exist that continue to present a risk for falling or injury due to falls.” CMS Ex. 16 at 37. The policy also states: “If falling recurs despite initial interventions, staff will implement additional or different interventions, or indicate why the current approach remains relevant.” CMS Ex. 16 at 45.
Resident 1’s care plan for fall risk occurrence contains 20 items checked from one preprinted list, with two handwritten entries, and re-evaluation dates from June 2016, through October 2018. Among interventions checked are “[e]ncourage resident to call for assistance [as] needed.” A second checked intervention is “[m]onitoring of the resident’s whereabout and not leaving her/him unattended.” CMS Ex. 3 at 68. Post-fall progress notes and other documents indicate that facility responses after falls included the following:
- “Resident enrolled to falling star program. 2 person assist with dressing, bathing, grooming, hygiene, bed mobility and transferring. . . . Frequent monitoring to ensure residents safety. . . . Call light within reach.” CMS Ex. 3 at 85 (July 26, 2017);
- “[R]eminded patient to ask help from the staff or to use call light if assistance is needed; patient verbalized understanding,
- and said ‘sorry’ for doing it without asking help . . . . Instructed patient to use call light; verbalized understanding.” CMS Ex. 3 at 78 (September 4, 2017);
- “Resident transferred with three person assist for safety back to wheelchair. Encouraged resident to ask for assistance when needed. Resident verbalized understanding. . . . Call bell within reach. Will continue to reinforce teaching . . . .” CMS Ex. 3 at 91 (September 26, 2017);
- “Mechanical life used with 4 person assist to lay resident back in bed . . . . Call light was not used for assistance. . . . Resident left with . . . call light within reach . . . . Resident already enrolled in Falling Star.” CMS Ex. 3 at 100 (December 14, 2017);
- “Assisted by multiple licensed staff from floor to chair without incident. . . . [C]all bell within reach. . . . Will continue to monitor closely.” CMS Ex. 3 at 106 (December 30, 2017);
- “Resident admitted she turned off pressure pad alarm in bed by herself because the sounds bothers [sic] her and resident stated that ‘My call light doesn’t make any sounds! It is useless!’ Explained to resident that call light does not make sounds, reminded and educated resident to use call light for any help. Also, explained risks and benefits of turning off pressure pad alarm. . . . [Daughter] stated that ‘My mom does not even remember that she was on floor.’ . . . [N]ew order to enroll to Falling Star program . . . .” CMS Ex. 3 at 115 (June 6, 2018);
- “RN Supervisor explained to resident that notifying staff for toileting and transfers is extremely important to prevent such incidents such as this one. . . . Resident failed to use call light system in both bedroom and bathroom.” CMS Ex. 3 at 120 (August 2, 2018);
- “[T]eaching provided to staff and resident. . . .“ CMS Ex. 3 at 58 (August 19, 2018); and
- “Patient was re-educated in proper posture and use of call light for assistance. Encouragement on do not get up without assistance. Patient stated ‘I’m trying to be more independent.’ Emphasis on precautions. Patient willing to follow recommendations.” CMS Ex. 3 at 59 (October 2, 2018).
Shortly after Resident 1’s sixth fall on June 6, 2018, Petitioner’s staff completed an MDS assessment dated July 2, 2018, which indicated that Resident 1 needed “Extensive assistance” with all Activities of Daily Living except eating, including bed mobility (i.e., positioning in bed), transfers between different surfaces (e.g., from bed to standing position); walking in room, corridor, and locomotion off unit, dressing, and toilet use. CMS Ex. 3 at 12. Resident 1 was assessed with “Total dependence” on staff for bathing; was “Not steady, only able to stabilize with staff assistance” when moving from a seated to standing position, walking with assistive device, turning around and facing the opposite direction when walking, moving on and off toilet, and transferring from surface to surface; had impairments with upper extremities (shoulder, elbow, wrist, hand); and used a walker and wheelchair for mobility. CMS Ex. 3 at 13-14.
On October 2, 2018, at 7:45 p.m., Resident 1 had a witnessed fall, reflected in a “Change of Condition” progress note. CMS Ex. 3 at 51-56. A Licensed Vocational Nurse (LVN) responded to a chair alarm in Resident 1’s room and “witnessed Resident falling to ground from standing position and CNA attempting to prevent the fall. Resident noted lying on left side partially in Room 22 and partially in bathroom.” CMS Ex. 3 at 54. The note states:
CNA assisted resident from bed to wheelchair, then wheelchair to toilet (cause of alarm sounding). CNA was turning off chair alarm and resident stood up without assistance. Prior to standing, CNA explained to resident not to stand up without assistance and that she was going to help her. Resident ignored CNA’s teaching and stood up on her own. Resident pushed hand up against door connecting to Room 22, which then pushed open and resident fell on left side of body. Resident did not hit her head, per CNA and resident. Resident stated “I thought the door was a wall.” Resident c/o pain 8-9/10 to left hip. . . . 9-11 notified. Arrived around 8 PM and assessed resident. Resident transferred to flat board followed by gurney with assistance of paramedics, firefighter, and licensed nurses. . . . Resident transferred to LBMMC [Long Beach Memorial Medical Center] at around 8:30 PM.
CMS Ex. 3 at 53-54; see CMS Ex. 3 at 57 (duplicate R.N. Supervisor note). Facility transfer documents state reasons for transfer including status post fall from standing position and “possible left hip” fracture. CMS Ex. 3 at 43.
Hospital emergency department (ED) records state that Resident 1’s diagnoses included Alzheimer’s disease, coronary artery disease, CVA on Eliquis, dementia, and renal failure and that she arrived by ambulance after “mechanical slip and fall earlier today.” CMS Ex. 4 at 4. Resident 1 presented with complaints of left hip pain, but no other associated symptoms or factors. CMS Ex. 4 at 4. Initial x rays revealed a “moderately displaced left intertrochanteric femoral fracture.” CMS Ex. 4 at 7. She was subsequently admitted from the ED into the hospital as an inpatient for an orthopedic consultation and, following a cardiology consultation, was scheduled for surgical repair of the left hip fracture on October 5, 2018. While being positioned on the table in the operating room, Resident 1 went into cardiac arrest and was non responsive when transferred from the operating room into post acute and intensive care units. Following discussions with Resident 1’s daughter, Resident 1 began receiving palliative care and was pronounced dead at 11:30 that night. CMS Ex. 4 at 8-12, 18, 21-22, 36-40; CMS Ex. 6.
2. Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(d) (Tag F689) because it did not take all reasonable steps to provide the supervision and assistance necessary to prevent a foreseeable accident and, as a result, Resident 1 fell and was severely injured, required inpatient hospitalization for surgical repair of a fractured femur, and died following cardiac arrest in preparation for surgery.
The Social Security Act requires SNFs to “provide services to attain or maintain the highest practicable physical, mental, and psychosocial well-being of each resident, in accordance with a written plan of care.” 42 U.S.C. § 1395i-3(b)(2). In furtherance of this mandate, the Secretary promulgated the general quality of care regulation at 42 C.F.R. § 483.25, which states that the SNF “must ensure that residents receive treatment and care in accordance with professional standards of practice,” based on a comprehensive resident assessment, a comprehensive care plan, and resident choice. Subsection 483.25(d) imposes specific obligations upon a facility related to accident hazards and accidents, as follows:4
The facility must ensure that ˗
(1) The resident environment remains as free of accident hazards as is possible; and
(2) Each resident receives adequate supervision and assistance devices to prevent accidents.
Therefore, subsection 483.25(d)(1) requires that a facility address foreseeable risks of harm from accidents “by identifying and removing hazards, where possible, or, where the hazard is unavoidable because of other resident needs, managing the hazard by reducing the risk of accident to the extent possible.” Maine Veterans’ Home - Scarborough, DAB No. 1975 at 10 (2005) (explaining the inherent standard of care in section 483.25(h)(1)). The provisions of section 483.25(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). Further, 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 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).
Although Petitioner admits that Resident 1 had a history of falls at the facility, Petitioner asserts that it was in substantial compliance with Medicare program requirements because it provided Resident 1 with required assistance and monitoring and that the October 2, 2018 fall was unpreventable because Resident 1 did not comply with the reminder to request assistance before standing. P. Br. at 9-12. These arguments are unavailing.
The record reflects that, over a period of two and a half years, Petitioner assessed Resident 1 as at high risk for falls and determined that, among other interventions, monitoring her whereabouts and not leaving her unattended would help mitigate that risk. CMS Ex. 3 at 68. On July 2, 2018, three months before her ninth fall, Petitioner assessed Resident 1 as requiring extensive assistance when toileting. CMS Ex. 3 at 12. In making these determinations, Petitioner decided that in-person supervision and assistance were reasonable interventions calculated to manage, if not eliminate, the foreseeable fall risk hazard that occurred when toileting.
However, on August 19, 2018, Resident 1 sustained her eighth fall in little more than one year, this time while toileting with the assistance of one CNA. CMS Ex. 3 at 97, 148. The “change of condition” progress note describes this “assisted fall” as follows:
CNA reported . . . he was assisting resident to use the bathroom. Wheelchair wheels were locked in bathroom. Resident stood up, chair was removed, and resident held onto commode handles while CNA was assisting her with her clothes. Resident then removed her hands from the commode while facing forward towards the commode in attempt to pull down her pants and pull up in order to use the bathroom. Resident then lost her balance. Due to resident’s weight, CNA was unable to hold resident up and gently assisted Resident to the floor, sitting on her buttocks. . . . Teaching provided to staff and resident.
CMS Ex. 3 at 97 (emphasis added). Also, on August 19, 2018, Petitioner’s staff evaluated Resident 1 to be a “HIGH RISK” for falls. Thus, only three months before the October 2, 2018 fall at issue, Petitioner was on notice that the risk for Resident 1 falling when toileting with the assistance of one CNA was not only foreseeable but had in fact occurred.5 That Petitioner now argues that it provided adequate assistance, monitoring, and education to Resident 1 at the time of her fall on October 2, 2018, is contradicted by the record evidence.6 Cf. P. Br. at 9-11. The prefatory language to the quality of care team (“IDT”)/care planning meetings or that the facility was monitoring Resident #1 for dizziness and sedation.” CMS Ex. 24 ¶ 9.
regulation at issue, 42 C.F.R. § 482.35, applies to all enumerated quality of care provisions, including the accident deficiency at issue here. CMS Ex. 1 at 11; see North Las Vegas Care Center, DAB No. 2946 at 6 (2019). The record consistently supports that Petitioner did not sufficiently assess and provide interventions to Resident 1 to prevent accidents.
I also note Petitioner lists “[e]ncourage resident to call for assistance [as] needed” as another fall prevention intervention. CMS Ex. 3 at 68. However, Petitioner argues that Resident 1’s “cognitive deficits also contributed significantly to her fall risk. . . . Resident 1 had been reminded not to try to stand unassisted just minutes before her fall on October 2, yet even that very recent reminder was insufficient to prevent her from doing just that.” P. Br. at 12 (emphasis in original). However, Petitioner had provided verbal reminders and instructions to Resident 1 as interventions following her prior eight falls, from July 6, 2017, through August 19, 2018, yet Resident 1 continued to fall. CMS Ex. 3 at 58-59, 78, 85, 91, 100, 106, 115, 120. On June 6, 2018, for example, Petitioner’s staff reminded Resident 1 that, contrary to Resident 1’s complaint, call lights do not make sounds. CMS Ex. 3 at 115. In the same encounter, Resident 1’s daughter spoke to Resident 1 by telephone after she fell, then advised staff: “My mom does not even remember that she was on floor.” CMS Ex. 3 at 115. On July 2, 2018, less than one month later, Petitioner assessed Resident 1 at BIMS score 9, which is near the lowest end of moderate cognitive impairment, or borderline severe impairment. CMS Ex. 3 at 7. In the progress note documenting the October 2, 2018 fall, only three months after the cognitive assessment, the LVN writes that “Resident ignored CNA’s teaching and stood up on her own.” CMS Ex. 3 at 72. By this point, Petitioner’s attempt to stand alone when unattended in contravention of the CNA’s instructions is unsurprising. See CMS Ex. 24 ¶ 8 (“In my professional experience, however, individuals with documented cognitive deficits and Alzheimer’s disease, like Resident #1, cannot be relied upon to remember, and comply with, instructions given to them by nursing staff.”).
That Petitioner continues to argue that Resident 1 should have paid closer attention to staff instructions and warnings is puzzling. Petitioner’s Fall Risk Assessment Policy, in effect during this period, provides: “If falling recurs despite initial interventions, staff will implement additional or different interventions, or indicate why the current approach remains relevant.” CMS Ex. 16 at 45. Elsewhere, the policy requires that if a resident continues to fall despite interventions, staff will re-evaluate the situation and, in consultation with the attending physician, “document the basis for conclusions that specific irreversible risk factors exist that continue to present a risk for falling or injury due to falls.” CMS Ex. 16 at 37. No such irreversible risk factors are documented anywhere in the record, and Petitioner submitted no evidence to support why it
continued to rely on verbal warnings as a fall risk intervention for this cognitively impaired and highly forgetful resident. The record supports that such warnings simply did not work.
The record contains some evidentiary inconsistencies as to the presence, or absence, of the attending CNA during Resident 1’s October 2, 2018 fall while toileting. In her declaration, the attending CNA stated she told Resident 1 that “I would be right here by the door” and was turning off the wheelchair alarm when Resident 1 stood up unassisted and fell. CMS Ex. 18 at 1; see P. Ex. 3 at 2. It is unclear whether the CNA was inside the bathroom door or outside.7 The LVN progress note for October 2, 2018, states that the CNA was “turning off chair alarm and Resident stood up without assistance.” CMS Ex. 3 at 72. The hospital ED admitting records of the same date state that the family advised the admitting physician that Resident 1 was “somewhat unstable on her feet and was walking to the bathroom when she leaned on the door to stabilize herself but it opened and she fell.” CMS Ex. 4 at 4. The state agency intake form for the complaint investigation initiated by Resident 1’s daughter, dated October 15, 2018, alleges neglect and understaffing and states that “[a] CNA was supposedly in the restroom with her” during the fall. CMS Ex. 28 at 1. These inconsistencies about the extent of the CNA’s presence or proximity to Resident 1 during the fall, however, provide no basis for overturning the deficiency. No matter the distance, the CNA was not actively supervising Resident 1 or in a position to assist Resident 1 and ensure a fall did not occur. As one of the nurse surveyors testified in this proceeding:
In my professional opinion, [the CNA] should have never left Resident #1’s side while she toileted as required by the care plan, falling star program, Urinary Toileting Program, Resident #1’s history of prior falls, the facility’s determination Resident #1 was at a high risk for falls, and best nursing practices. It is clear from the fall itself that Resident #1 was not being supported while using the toilet.
CMS Ex. 24 ¶ 13.
As explained earlier, CMS has the burden of establishing a prima facie case of noncompliance, and the burden then shifts to Petitioner to present sufficient evidence to rebut CMS’s prima facie case. Based on the record before me, I find that CMS has amply met its burden of producing sufficient evidence to establish a prima facie case
that the interventions provided by Petitioner were not reasonable or adequate interventions to prevent foreseeable accidents. Petitioner has not rebutted CMS’s prima facie case. Indeed, Petitioner does not appear to understand its burden in this case, arguing that it did all it could do and then attempted to place the burden on CMS to identify additional interventions that should have been implemented. P. Br. at 13. Regardless as to shifting burdens in this case, I find that a preponderance of the evidence in the record supports the deficiency in this case.
In leaving Resident 1 insufficiently attended when toileting on October 2, 2018, contrary to her care plan, Petitioner failed to take all reasonable steps to ensure that she received the supervision needed to mitigate the foreseeable risk of harm she faced from falling when attempting to stand on her own from the toilet. Briarwood, DAB No. 2115 at 11. Resident 1 then fell, suffered a severe injury, and required inpatient hospitalization and surgery, where she died following cardiac arrest immediately prior to surgery. Therefore, Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(d) with respect to Resident 1.
3. The $7,350 per-instance CMP that CMS imposed is fully supported by the facts and law in this case.
CMS imposed a single per-instance CMP in the amount of $7,350 on Petitioner. CMS Ex. 22 at 2. When determining whether a CMP amount is reasonable, I apply the factors listed in 42 C.F.R. § 488.438(f): 1) facility history of noncompliance; 2) facility financial condition; 3) factors specified in 42 C.F.R. § 488.404; and 4) facility 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)(4). The factors listed in 42 C.F.R. § 488.404 include: 1) scope and severity of the deficiency; 2) relationship of the deficiency to other deficiencies resulting in noncompliance; and 3) facility 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 §§ 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)-(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 will sustain it. Coquina Ctr., DAB No. 1860 (2002).
In the present matter, Petitioner challenges the imposition of the CMP as “unreasonable” and argues that CMS “should have imposed” a lower CMP. P. Br. at 15. Petitioner argues for a lower CMP for the following reasons: 1) Petitioner’s “strong compliance history . . . does not reveal an alarming pattern of non-compliance;” 2) the degree of harm or potential harm and limited scope of deficiencies (isolated deficiency); and 3) low culpability, based on Petitioner’s consistent assessment and interventions related to Resident 1’s fall risk. P. Br. at 15.
CMS, by contrast, argues that its penalty amount is reasonable based on Petitioner’s culpability, the seriousness of the deficiencies cited, and lack of evidence concerning Petitioner’s financial condition. Specifically, CMS asserts that Petitioner failed to adequately supervise Resident 1, who had Alzheimer’s disease and was known to be a “high risk for falls.” CMS contends that the deficiencies cited are serious, as Resident 1 fell at least 8 times in 14.5 months before the October 2, 2018 fall. CMS points out that Petitioner offered no evidence concerning its financial condition. CMS maintains that Petitioner failed to implement needed interventions and to provide adequate supervision. CMS Br. at 24 25.
Facility’s History of Non-Compliance: Petitioner has a history of noncompliance from 2015 through 2018, but primarily at scope and severity level “D” and “E”, and not involving the accident deficiency (Tag F689) at issue here. CMS Ex. 23 at 2-5. This history provides modest support for CMS’s CMP in this case.
Scope and Severity of Deficiencies and Relationship Between Deficiencies: This case involves immediate jeopardy in which Resident 1 received an injury consisting of a fractured left hip and inpatient hospitalization for acute inpatient care and surgical repair. Resident 1 died from cardiac arrest immediately before surgical repair of the left hip fracture. This factor supports a substantial CMP amount.
Culpability: Petitioner is very culpable in this case. Over a period of years, Petitioner consistently assessed Resident 1 as a high fall risk and requiring extensive staff assistance. Resident 1 had significant cognitive impairment and an extensive history of falls (nine in a fourteen month period), while Petitioner primarily relied upon verbal instructions to Resident 1 to request assistance or to use her call light to obtain staff assistance and minimize her risk of accident. The record is replete with evidence to support that Petitioner was on notice that Resident 1 was unable to comprehend and follow these verbal instructions. Petitioner’s care plan quite reasonably called for Resident 1 not to be left unattended. Yet, despite all of this, Petitioner’s staff left her sufficiently unattended when toileting on October 2, 2018, that she was able to stand unassisted before falling to the ground and fracturing her left hip. This fall resulted in
significant injury that only surgery could repair. Following Resident 1’s transfer to an inpatient hospital for that surgical repair, she went into cardiac arrest when being positioned on the surgical table and died soon after.
I find it particularly troubling that Petitioner did not comply with all of its own safety interventions in Resident 1’s “At Risk for Fall Occurrent” care plan. Petitioner’s culpability is sufficiently high to justify a CMP amount that is greater than the amount CMS imposed in this case.
Financial Condition of the Facility: Petitioner presents no evidence of its financial condition. Therefore, this is not a factor requiring further consideration.
CMP Amount: The range of per-instance CMPs available to CMS for this survey was $2,140 to $21,393. 45 C.F.R. § 102.3 (2019). A per-instance CMP of $7,350 is at the lower end of the penalty range, which is easily supported based on the factors considered above.
For the reasons set forth above, I sustain CMS’s initial determination that Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(d) and that a $7,350 per instance CMP is fully supported by the relevant statutory and regulatory factors in this case.
Scott Anderson Administrative Law Judge
1. All citations to the Code of Federal Regulations are to the version in effect at the time of the survey unless otherwise indicated.
- back to note 1 2. CMS or the state agency designates the scope and severity level using a letter from A through L based on a scope and severity matrix published in the State Operations Manual, Ch. 7, § 7400.3.1 (Rev. 185, Eff. Nov. 16, 2018). Levels A, B, or C indicate a deficiency that presents no actual harm but has the potential for minimal harm, which means the facility technically remains in substantial compliance. 42 C.F.R. § 488.301. Levels D, E, or F indicate a deficiency that presents no actual harm but has the potential for more than minimal harm that does not amount to immediate jeopardy. Levels G, H, or I indicate a deficiency that involves actual harm that does not amount to immediate jeopardy. Finally, levels J, K, and L indicate a deficiency that constitutes immediate jeopardy to resident health or safety.
- back to note 2 3. BIMS scores are categorized into 3 levels: cognitively intact (13–15), moderately impaired (8–12), and severe impairment (0–7). See, e.g., CMS Long-Term Care Facility Resident Assessment Instrument 3.0 User’s Manual, Version 1.17.1, Ch. 3 § C0500 at C 15 and C-16 (Oct. 2019), available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/NursingHomeQualityInits/ MDS30RAIManual; https://downloads.cms.gov/files/mds-3.0-rai-manual-v1.17.1_october_2019.pdf (last visited May 20, 2021). Thus, Resident 1’s BIMS score indicates that her cognition was at the lower end of moderate impairment, approaching severe impairment.
- back to note 3 4. 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).
- back to note 4 5. Indeed, Petitioner knew that toileting presented a fall risk to Resident 1 back as far as 2017. On July 17, 2017, Resident 1 “went to the bathroom by herself and when she got up from the toilet to pull up her briefs she fell, then a male nurse came in and picked her up.” CMS Ex. 3 at 85. A nurse surveyor testified on this subject as follows: “In my professional opinion, given the history of Resident #1’s multiple falls, including at least four falls that occurred during toileting, immediately before toileting, or immediately after toileting, the October 2, 2018, fall that led to Resident #1’s death, which was her ninth fall at Broadway within about a year, was avoidable if effective care plans were implemented and IDT meetings were held after each fall to assess the effectiveness of the interventions.” P. Ex. 24 ¶ 16 (emphasis omitted).
- back to note 5 6. One of the nurse surveyors testified Resident 1’s first and second toes on her left foot (i.e., the big and long toes) had been amputated in 2015, which “further inhibited her balance.” CMS Ex. 24 ¶ 9. That nurse surveyor also pointed out that Resident 1 was taking Lyrica and, in August 2018, a pharmacist warned Petitioner’s staff that Lyrica “increases risk of falls due to dizziness and sedation.” CMS Ex. 24 ¶ 9; CMS Ex. 3 at 154. The nurse surveyor testified that “[f]rom my review of Resident #1’s records, it does not appear the pharmacist’s instructions were ever discussed in any interdisciplinary
- back to note 6 7. Surveyor notes document the bathroom as having two doorway entrances, to and from Rooms 20 and 22, and that the bathroom measured 48” x 80”. CMS Ex. 19 at 13. Photographs of the bathroom reflect a small enclosed space. CMS Ex. 15; CMS Ex. 24 ¶ 15.
- back to note 7