Ararat Nursing Facility, DAB CR5737 (2020)

DECISION

Ararat Nursing Facility (Petitioner or facility), a skilled nursing facility (SNF), routinely left a resident (Resident 223) unsupervised in her bed, even though she had a documented risk and history of falls and a care plan requiring staff to provide close supervision when she was in her bed.  On February 4, 2018, a certified nurse assistant (CNA) found Resident 223 on the floor after leaving her bed.  This fall resulted in an acute left intertrochanteric femoral fracture requiring surgical repair during a five-day inpatient hospitalization.

Based on this situation, as well as ones involving Residents 161 and 201, the Centers for Medicare & Medicaid Services (CMS) found that Petitioner had isolated deficiencies of the Medicare participation requirement for SNFs at 42 C.F.R. § 483.25(d) (accidents), which constituted actual harm to residents.  CMS imposed a $10,000 per instance civil money penalty (CMP) on Petitioner. 

Petitioner argues that the falls for Residents 201 and 223 were unavoidable, as supported by clinical records and expert opinion.  Petitioner also argues that its CNA was appropriately transferring Resident 161 by Hoyer lift and that Resident 161 was

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uninjured.  Petitioner further argues that the CMP imposed was not reasonably related to a legitimate remedial purpose and CMS did not appropriately consider the relevant regulatory factors. 

As I explain below, Petitioner’s noncompliance, which involved actual harm to Resident 223, supports CMS’s determination that Petitioner was not in compliance with program participation requirements.  Further, the incident involving Resident 161 further supports the deficiency, even though that resident was not physically harmed.  Finally, I conclude that it is unnecessary to decide whether the situation involving Resident 201 further supported the finding of substantial noncompliance.  The facts related to Residents 223 and 161 are sufficient to uphold the cited deficiency and the amount of the CMP imposed.

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.  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

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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). 

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 the SNF’s noncompliance or a per‑day CMP for the number of days an SNF is not in substantial compliance.  42 U.S.C. § 1395i‑3(h)(2)(A), (h)(2)(B)(ii)(I); 42 C.F.R. § 488.430(a).  For CMPs assessed on or after February 3, 2017, and for deficiencies that occurred after November 2, 2015, the CMP amounts may range as follows:  $2,097 to $20,965 for per-instance CMPs; $105 to $6,289 per day for less serious noncompliance; or $6,394 to $20,965 per day for more serious noncompliance that poses immediate jeopardy to the health and safety of residents.  45 C.F.R. § 102.3 (2017); 82 Fed. Reg. 9,174, 9,175, 9,182-83 (Feb. 3, 2017); 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 noncompliance determination, then the SNF may request a hearing before an administrative law judge (ALJ) to challenge CMS’s 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. §§ 488.408(g)(1), 488.330(e), 488.434(a)(2)(viii), 498.3(b)(13)-(14); see also 5 U.S.C. §§ 554, 556.  Either the SNF or CMS may request Departmental Appeals Board (DAB) review of an ALJ’s decision.  42 C.F.R. § 498.80.

With regard to challenging 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, in order to prevail, prove substantial compliance by a preponderance of the evidence.  Hillman Rehab. Ctr., DAB No. 1611 at 8 (1997); see Batavia Nursing & Convalescent Inn, DAB No. 1911 (2004); Batavia Nursing & Convalescent Ctr., DAB No. 1904 (2004), aff’d, Batavia Nursing & Convalescent Ctr. v.

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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).

II.  Background and Procedural History

Petitioner is an SNF that operates in Mission Hills, California.  Surveyors from the California Department of Public Health (state agency) conducted a standard survey of Petitioner’s facility, which concluded on April 9, 2018.  CMS Exhibit (Ex.) 9 at 1.  The state agency subsequently issued a Statement of Deficiencies indicating the facility was not in substantial compliance with numerous Medicare program participation requirements for SNFs, including 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 “G” (i.e., isolated deficiency constituting actual harm that is not immediate jeopardy) related to three residents (Residents 161, 201, and 223).  CMS Ex. 9 at 25-38. 

Due to this deficiency, on April 23, 2018, Los Angeles County’s public health agency issued an initial determination imposing a denial of payment for new admissions (DPNA), effective July 9, 2018, if Petitioner failed to achieve substantial compliance by that date, and recommending that CMS impose a CMP and termination of Petitioner’s Medicare provider agreement by October 9, 2018, if Petitioner failed to achieve substantial compliance by that date.  Hearing Req. Attach. at 3.  Petitioner filed a plan of correction with Los Angeles County’s public health agency and, on May 30, 2018, the state agency revisited the facility and did not find any deficiencies.  CMS Ex. 1 at 1-2. 

On June 15, 2018, CMS issued an initial determination adopting the state agency survey findings and imposing a $10,000 per-instance CMP under 42 C.F.R. § 488.430 for the noncompliance identified under Tag F689 (i.e., 42 C.F.R. § 483.25(d)).  Petitioner’s Response to Order to Show Cause, Exhibit A (P. Ex. A) at 1-2. 

Petitioner requested a hearing before an ALJ to dispute the June 15, 2018 initial determination.  Following receipt of Petitioner’s hearing request, the ALJ originally assigned to this case issued an Acknowledgment and Order to Show Cause concerning Petitioner’s untimely filing, to which Petitioner filed a response.  The ALJ accepted the hearing request as timely and, on September 20, 2018, issued a Pre-Hearing Order (Order) establishing a prehearing exchange schedule for the parties.  In that order, the ALJ directed the parties to file briefs, proposed exhibits, and written direct testimony for all witnesses they wanted to present in this case. 

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

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In compliance with the Order, CMS filed an exchange, including a combined motion for summary judgment and prehearing brief (CMS Br.) and nine proposed exhibits (CMS Exs. 1-9).  CMS did not offer any witness testimony.  Petitioner timely filed an exchange consisting of a prehearing brief (P. Br.) and 10 proposed exhibits (P. Exs. 1‑10), which included declarations from four proposed witnesses (P. Exs. 5, 8-10). 

III.  Decision on the Record

Petitioner did not object to any of CMS’s exhibits, and CMS did not object to any of Petitioner’s exhibits or request to cross-examine Petitioner’s proposed witnesses.  See Order ¶¶ 7-10, 12; Civil Remedies Division Procedures (CRDP) §§ 16(b), 19(b).  Absent objections from the parties, I admit CMS Exs. 1-9 and P. Exs. 1-10 into the record.  See Order ¶ 7; CRDP § 14(e).  Further, because there is no need to convene an evidentiary hearing to cross-examine Petitioner’s witnesses, I issue this decision based on the written record.  See Order ¶ 12; CRDP § 19(d).

IV.  Issues

1) Whether Petitioner failed to substantially comply with the requirements of 42 C.F.R. § 483.25(d) (Tag F689),2 relating to accident prevention and adequate supervision; and

2) If so, whether the CMP that CMS imposed is reasonable. 

V.  Findings of Fact and Conclusions of Law

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

1. On February 4, 2018, Resident 223, an unsupervised resident, suffered an unwitnessed fall that resulted in a left hip fracture requiring inpatient hospitalization and surgical repair.  This fall came after a long history of falls at the facility and despite an intervention in the Plan of Care to instruct staff not to leave Resident 223 “unattended alone” in her room.

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Resident 223, an 89-year-old woman, originally was admitted to the facility on December 27, 2012, with multiple diagnoses, including congestive heart failure, chronic kidney disease, Alzheimer’s disease, dementia with behavioral disturbance, and Parkinson’s disease.  P. Ex. 1 at 1-2.  By at least February 14, 2015, Resident 223 was assessed as a fall risk secondary to unsteady balance during transfers, with a history of falls prior to admission and requiring staff assistance to stabilize balance.  CMS Ex. 3 at 2.  Despite this, the resident’s care plan indicates that the resident was observed on the floor on February 19, 2015, December 20, 2015, February 16, 2017, September 4, 2017, December 12, 2017, February 4, 2018, and March 8, 2018.3   CMS Ex. 3 at 3; see CMS Ex. 3 at 15-27 (facility investigations, reports, summaries, and interventions for falls on September 4, 2017, December 12, 2017, February 4, 2018, and March 8, 2018). 

Interventions in 2015 included restorative nursing range of motion exercises and assisted ambulation with front wheel walker (fww) as tolerated, physical therapy (PT) and occupational therapy (OT), and use of a magnetic alert device attached to the resident “at all times.”  CMS Ex. 3 at 2.  An intervention initiated December 20, 2015, states:  “Instruct staff do not leave resident unattended alone in her room.”  CMS Ex. 3 at 3 (emphasis added).  An intervention dated February 14, 2015, states “[a]ssure ambulation with walker and assistance only.”  CMS Ex. 3 at 2.  Post-fall interventions included a mat on the floor by the bed to prevent injuries (September 4, 2017) and staff charting at a station in close proximity to the resident’s room “to supervise resident closely while she is taking 1 pm - 3 pm nap” (December 13, 2017).  CMS Ex. 3 at 15-16. 

Shortly after the December 12, 2017 fall, on December 15, 2017, Petitioner’s staff completed a Minimum Data Set assessment that indicated Resident 223:  needed “Extensive assistance” (one person to assist) with bed mobility (i.e., positioning in bed), transfers between different surfaces (e.g., from bed to standing position), walking in the corridor, dressing, eating, toilet use, and personal hygiene; had “Total dependence” on staff (one person to assist) with locomotion in her unit of the facility and to other units in the facility; was not observed over a seven-day period to walk in her room; was “Not steady, only able to stabilize with staff assistance” when moving from a seated to standing position, walking with assistive device, moving on and off toilet, and

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transferring from surface to surface; had impairments with all upper and lower extremities; and used a walker and wheelchair for mobility.  CMS Ex. 4 at 1, 8. 

On February 4, 2018, at 10:00 a.m., Resident 223 had an unwitnessed fall in her room, was found sitting on the floor next to her roommate’s bed, and stated that she had tried to sit on her wheelchair, but lost her balance and fell.  CMS Ex. 3 at 18-19.  She complained of pain in her left hip and leg and was taken by ambulance to an acute care hospital, where she was admitted as an inpatient.  CMS Ex. 3 at 18, 28-34.  Hospital x-rays revealed an “acute left intertrochanteric femoral fracture,” and she underwent the surgical procedure for open reduction and internal fixation of intertrochanteric fracture with hip pin and locking intramedullary rod.  CMS Ex. 3 at 30-33; see also P. Ex. 1 at 2.  The hospital assessment and plan stated the resident had advanced Alzheimer’s dementia and required PT on her discharge.  CMS Ex. 3 at 33. 

On February 9, 2018, Resident 223 was discharged from the hospital and readmitted to Petitioner’s facility.  CMS Ex. 3 at 13-14.  After the return of Resident 223, Petitioner implemented an intervention of having a CNA “take the resident to dining room after breakfast to keep her under close supervision” (February 5, 2018).  CMS Ex. 3 at 17.  A Fall Risk Assessment dated April 24, 2018, assesses the resident at a score of 26, with a score above 10 representing “high risk” of falls.  CMS Ex. 3 at 1. 

2. On April 3, 2018, a single CNA transferred Resident 161 from her bed to a wheelchair using a Hoyer lift even though the Plan of Care for Resident 161 specified that two persons were to assist Resident 161 with transfers.   

Resident 161, an 88-year-old woman, was originally admitted to Petitioner’s facility on April 11, 2016, with diagnoses including general muscle weakness, altered mental status, difficulty walking, seizures, Alzheimer’s disease, major depressive disorder (single episode), osteoporosis, repeated falls, and a history of falling.  CMS Ex. 7 at 1-2.  Her care plan indicates that she was dependent in transfers, with goals including “demonstrate the ability to transfer safely as evidenced by no fall through . . . Target Date:  05/30/2018” and “minimize potential for fall/injury through . . . Target Date:  05/30/2018.”  CMS Ex. 7 at 3.  Care plan interventions include:  “Transfer:  Have 2+ persons transfer resident in and out of bed and w/c daily as needed.  Use mechanical lift as needed.  Date Initiated 03/01/2018.”  CMS Ex. 7 at 3.  The resident was also to be taken from her room onto the unit or around the facility “daily as needed.”  CMS Ex. 7 at 3. 

On April 3, 2018, the state surveyor observed one CNA transferring Resident 161 from bed to wheelchair by Hoyer lift, with no other staff assistance.  CMS Ex. 9 at 36.  When interviewed by the surveyor, the CNA “stated she should have asked another staff for help to move Resident 161, because it is not safe with only one person using the Hoyer lift.”  CMS Ex. 9 at 36.

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Excerpts from the manufacturer’s Hoyer lift User Manual provide multiple warnings concerning lifting a patient, including that misuse can “cause the patient lift to tip over.”  CMS Ex. 7 at 7; P. Ex. 4 at 16.  The warnings also provide:  “Although [the manufacturer] recommends that two assistants be used for all lifting preparation, transferring from and transferring to procedures, our equipment will permit proper operation by one assistant.  The use of one assistant is based on the evaluation of the health care professional for each individual case.”  P. Ex. 4 at 15.  

The record contains a Minimum Data Set resident assessment, dated February 26, 2018, prepared because of a “significant change in status.”  CMS Ex. 4 at 25‑69.  The assessment states that the resident had unclear speech, was rarely or never able to make herself understood, and only sometimes understood others.  CMS Ex. 4 at 30.  The resident had short-term and long-term memory problems and was unable to recall the current season, location of her room, staff names and faces, or that she was in a nursing home swing bed.  CMS Ex. 4 at 32.  She had severely impaired cognitive skills for daily decision making and “never/rarely made decisions.”  CMS Ex. 4 at 32.  The assessment also states that Resident 161 was totally dependent on staff for transfers between surfaces, including from bed to wheelchair, and required two or more persons for physical assistance.  CMS Ex. 4 at 39. 

Surveyor interview notes, dated April 3-5, 2018, indicate that the CNA who transferred Resident 161 alone by Hoyer lift “said she usually does the hoyer with 2 people and says she knows there needs to be 2 people.”  A registered nurse (RN) at the facility indicated to surveyors that one to three people can be required “to lift a resident,” and the staff will call for backup assistance when needed.  The RN also stated:  “It is better to have 2 person lifting.  If the MDS says two person physical [assist] then she should have asked for assistance.”  A second CNA stated that use of “hoyer lift is 2 people.  In CNA school [they] told us it is 2 people.”  A licensed vocational nurse (LVN) stated that “she was taught to not use hoyer lift alone, remind CNAs to get another person when they use the hoyer lift.”  The LVN stated that during an in-service, the RN stated “for there to be 2 people when using the Hoyer lift.”  The Director of Nursing (DON) also stated that “even in the policy it should be two people using the hoyer lift.”  CMS Ex. 6 at 2. 

3. On December 30, 2017, Resident 201, an unsupervised resident, suffered an unwitnessed fall that resulted in a left femoral fracture requiring inpatient hospitalization and surgical repair.  Resident 201 had previously suffered no falls at the facility, had good eyesight in her right eye, and had made progress over the course of more than a year at the facility, being able to ambulate 70-80 feet with a front wheeled walker and minimal assistance just two days before the fall.

Resident 201, a 91-year-old female, was originally admitted to Petitioner’s facility on August 19, 2016, with diagnoses then that included unspecified macular degeneration,

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cataract (left eye), anxiety and mood disorder, dementia, and other psychotic disorder.  P. Ex. 3 at 1-2.  A care plan entry, initiation date September 1, 2016, states that the resident was at risk for falls secondary to moderately impaired vision, with interventions that included monitoring the need for an eye examination and referral as needed.  CMS Ex. 5 at 16.  The care plan also reflects that, on September 1, 2016, the resident was to receive PT and OT interventions as “ordered/tolerated.”  CMS Ex. 5 at 5. 

A handwritten entry, dated September 19, 2016, states that the resident was able to stabilize balance without staff assistance when walking, turning around, and facing the opposite direction while walking.  CMS Ex. 5 at 5; see also CMS Ex. 5 at 15.  An initial psychiatric evaluation note, dated September 22, 2016, indicates that the resident had dementia, impaired memory and judgment, and agitation manifested, in part, by “getting out of bed and wheelchair,” for which she was prescribed medication and behavioral modification therapy.  CMS Ex. 5 at 1-2.  A handwritten care plan entry dated November 23, 2016, indicates that she was able to stabilize balance without assistance when moving from sit to stand, moving on and off toilet, and during surface to surface transfers.  CMS Ex. 5 at 5; P. Ex. 3 at 6 (same findings in fall risk assessment, dated August 15, 2017). 

A care plan entry, initiation date December 1, 2016, indicates that Resident 201 required ambulation assistance due to unsteady gait and balance, with staff providing minimum assistance to the resident when ambulating 70-80 feet daily, using a fww and walking belt.  CMS Ex. 5 at 3.  A history and physical note, dated August 11, 2017, documents that the resident had the capacity to understand and make decisions.  P. Ex. 3 at 4.  A restorative nursing weekly summary, dated December 28, 2017, reflects that Resident 201 maintained ambulating with minimum assistance for 70-80 feet while using a fww.  CMS Ex. 5 at 6.

On December 30, 2017, Resident 201 was observed on the floor of her room next to her walker in an unwitnessed fall.  CMS Ex. 5 at 7-8, 17‑18.  The resident told responding staff that the walker had gotten stuck in the door threshold, and the resident lost her balance and fell onto the walker.  CMS Ex. 5 at 7.  She complained of pain in her left hip, was alert and able to answer questions, and an x-ray revealed a left femoral fracture.  CMS Ex. 5 at 7, 9, 12.  The resident was transferred to an inpatient hospital on December 31, 2017, where she underwent surgical repair of the fracture.  CMS Ex. 5 at 9-10; P. Ex. 3 at 5. 

An optometric consult note, dated May 2, 2018, reflects that the resident has age-related macular degeneration and “low vision” in one eye, good vision in her right eye, uses a magnifying glass for reading, and neither the resident nor her responsible party want further treatment by the ophthalmologist.  The note also states that the resident is “not determined to be legally blind” under state guidelines.  P. Ex. 3 at 3.

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4. 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 devices necessary to prevent a foreseeable accident, and as a result, Resident 223 fell and was severely injured, and Resident 161 was placed in danger of suffering more than minimal harm.

Congress requires SNFs to “provide services to attain or maintain the highest practicable physical, mental, and psychosocial well-being of each resident, in accordance with a written plan of care.”  42 U.S.C. § 1395i-3(b)(2).  In furtherance of this mandate, the Secretary promulgated the general quality of care regulation at 42 C.F.R. § 483.25, which states that 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)

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(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).

Resident 223

Although Petitioner admits that Resident 223 had a history of falls at the facility, Petitioner asserts that it was in substantial compliance with Medicare program requirements because it implemented interventions after each fall.  Further, Petitioner relies on the testimony of its administrator and physicians who stated that the interventions were sufficient and the February 2018 fall was unavoidable.  Finally, Petitioner points out that the surveyors’ concern that Resident 223 did not have a magnetic alarm is incorrect since CMS had previously determined that such alarms were inappropriate for residents with the diagnoses that Petitioner had.  P. Br. at 8-11. 

The record reflects that, over a period of at least three years, Petitioner assessed Resident 223 as at risk for falls and determined that not leaving her unattended when alone in her room would help mitigate that risk.  CMS Ex. 3 at 2-3.  In making this determination, Petitioner decided that in-person supervision was a reasonable intervention calculated to manage, if not eliminate, the foreseeable fall risk hazard that being alone in her bed posed to Resident 223.  Further, during the approximately three-year period before Resident 223 was found on the floor in her room on February 4, 2018, with a fractured left femur, she was found on the floor no fewer than five other times.  Indeed, following Resident 223’s fall on February 4, 2018, the resident was again found on her floor on March 8, 2018 (her seventh documented fall). 

However, despite Resident 223’s care plan and repeated evidence that she was prone to trying to walk when left alone and unobserved in her room, Petitioner’s staff continued to leave Resident 223 alone and unattended when in her room.  The written statement of her CNA concerning the fall and injury on February 4, 2018, states, in part, as follows:

On 2/4/18 AM I gave [Resident 223] her morning care and after she was done with her breakfast as per her daughter[’s]  and resident’s request[.]  I placed her back to her bed for her morning nap.  On several occassions [sic], I, [a restorative nursing assistant, and a charge nurse] told [her daughter] that it is not safe to leave [Resident 223] in the bed alone even though we were assigned and instructed to check her from CNA charting area across her room.  [The daughter] still requested to allow her mother to have a nap.  At 9:45 am

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- 10 am I was at the charting area entering percentages of breakfast intake for my residents meanwhile glancing [illegible] corridor to check on [Resident 223].  She was in bed sleeping at 10:00 am[.]  I heard her voice, by the time I ran to her room she was sitting on the floor next to her roommates bed. 

CMS Ex. 3 at 5-6 (emphasis added). 

Thus, despite the care plan’s clear instructions not to leave Resident 223 unattended when alone in her room, Petitioner’s staff did just that, resulting in a foreseeable fall.  The CNA’s statement also concedes that the intervention of charting activity in close proximity to Resident 223’s room was inadequate for accident prevention.  In the span of less than 15 minutes, Resident 223 was asleep, out of her bed, and, yet again, on the floor in her room, this time severely injured.  Despite the wishes of the resident and her daughter, the regulation unambiguously requires that the facility provide such reasonable and adequate supervision as necessary to prevent foreseeable accidents.  The resident had advanced Alzheimer’s disease and a history of multiple unwitnessed falls.  The care plan required that Resident 223 not be left alone and unattended in her room.  Petitioner’s staff concedes that the intermittent supervision of Resident 223 in her bed from outside Resident 223’s room would result in unsafe conditions.  It is the Petitioner’s mandate to provide such supervision as necessary to prevent foreseeable accidents.  Resident 223’s fall after leaving her bed on February 4, 2018, with severe resulting injury, is one such foreseeable accident. 

Petitioner submits written declarations of its administrator, a medical expert, its medical director, and the attending physician to support that Resident 223’s fall was “unavoidable.”  P. Exs. 5, 8-10.  These declarations also assert that the surveyor’s reference to the removal of magnetic alert devices or alarms in assessing the Tag F689 deficiency ignores that state surveyors and CMS currently consider that the use of such alarms are not a suitable intervention for geriatric patients in general and Resident 223 in particular.  P. Br. at 9-10; P. Ex. 2 at 1, 4; P. Ex. 5 ¶ 2; P. Ex. 9 ¶ 5; P. Ex. 10 ¶ 5.  I agree with Petitioner’s argument that the decision to discontinue use of magnetic alarms, also referred to as tab alarms, throughout the facility in April 2017 is supported by revised CMS policy and industry research.  P. Ex. 6 at 2-3, 8, 11 (SOM, Appendix PP, Tag F689 discussion of position change alarms as restraints, effective Nov. 28, 2017); P. Ex. 7 (research article that increased use of bed alarms had no statistically significant effect on falls).  While I agree with Petitioner’s argument on this point, it is not dispositive to the issue before me.  The deficiency cited under Tag F689 is not based on Petitioner’s discontinuation of bed alarms prior to Resident 223’s fall on February 4, 2018, but instead is based on the lack of adequate supervision, as acknowledged by Petitioner in Resident 223’s care plans and in the written statement of Resident 223’s CNA concerning the February 4 fall.  Resident 223 sustained multiple falls after Petitioner discontinued

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bed alarms, and Petitioner did not put into place sufficient or adequate supervision of Resident 223 to prevent those subsequent and foreseeable accidents. 

Petitioner further argues that there is insufficient evidence in the record to support that the resident lacked the cognitive ability to use a call button for staff assistance.  P. Br. at 10-11.  I disagree.  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. 

The state agency Statement of Deficiencies states that, during an interview on April 6, 2018, a CNA stated that Resident 223 did not know how to use the call light, even though it was regularly left next to the resident when in bed.  CMS Ex. 9 at 31.  The Statement of Deficiencies further states that “during an observation, Resident 223 pressed the call light button only after the [Licensed Vocational Nurse] handed the call light to the resident and instructed her to push the button.”  CMS Ex. 9 at 31.  On April 9, 2018, the resident “was unable to explain what she does when she needs to call the nurse or the CNA.”  CMS Ex. 9 at 31. 

These assertions in the Statement of Deficiencies are supported by surveyor notes and medical documentation.  Surveyor notes from an April 6, 2018 interview with Resident 223’s daughter state that “her mother cannot use the call light and does not understand or forgets what the call light is and what it is for.”  CMS Ex. 6 at 1.  Psychiatric progress notes from March 2, 2017, through December 19, 2017, consistently document that Resident 223 had disorganized thought processes, impaired insight, judgment, and impulse control, was disoriented, had poor concentration, and had impaired short term memory, long term memory, and immediate recall.  CMS Ex. 3 at 8-12.  Her diagnoses included severe depression, dementia with behavioral disturbances, and generalized anxiety, for which she was prescribed anti-depressant and anti-anxiety medication.  CMS Ex. 3 at 8-12.  CMS has put forth sufficient evidence to establish a prima facie case that providing Resident 223 with a call light button was not a reasonable or adequate intervention to prevent foreseeable accidents.  CMS’s prima facie case remains unrebutted. 

In leaving Resident 223 alone and unsupervised in her room, 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 getting out of her bed.  Briarwood, DAB No. 2115 at 11.  Resident 223 fell, suffered a severe injury, and required inpatient hospitalization and surgery as a result.  Therefore, Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(d) with respect to Resident 223.

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Resident 161

The facts concerning this resident are largely undisputed.  Petitioner does not dispute that the surveyor observed a single CNA transferring Resident 161 from bed to wheelchair using the Hoyer lift, without assistance.  Petitioner also did not submit written direct testimony from the CVNs, LVN, RN, and DON refuting the statements they made to the surveyors regarding the need for two persons to use the Hoyer lift. 

Instead, Petitioner generally argues that the care plan and manufacturer instructions allow “permissible use” of the Hoyer lift by one person.  Petitioner summarizes that use of a Hoyer lift by a single person is to be evaluated on a case-by-case basis, depending on patient needs, and that Petitioner’s policy permits transfers by one, two, or three caregivers, as needed.  Petitioner further maintains that, in any event, Resident 161 sustained no injuries in this transfer and actual harm did not exist to sustain a level G deficiency.  P. Br. at 13-14; P. Ex. 4 at 4-5. 

Petitioner’s arguments are unavailing.  It is true that manufacturer instructions and facility policy may permit mechanical lift transfers by one to three caregivers, depending on circumstances surrounding a patient transfer.  In this case, however, Resident 161’s assessment, dated February 26, 2018, unambiguously states that the resident is totally dependent on full staff performance for transfers from bed to wheelchair and requires two or more persons for physical assistance in those transfers.  CMS Ex. 4 at 39.  The resident’s care plan also states that the resident requires a “2+ persons transfer” from bed to wheelchair “as needed,” with use of the mechanical lift “as needed.”  CMS Ex. 7 at 3. 

Surveyor interview notes indicate that facility CNAs are instructed and receive in-service training that use of a Hoyer lift requires 2 persons, as supported by statements of the transferring CNA, a second CNA, an LVN, an RN, and the DON.  CMS Ex. 6 at 2.  While it is conceivable that a single CNA may safely transfer a resident by mechanical lift without risk, this is not such a case.  Resident 161 was significantly cognitively impaired and was largely unable to understand or to be understood by others, creating substantial risk of injury or accident during an unassisted mechanical lift transfer by one person.  The fact that harm did not result during this transfer also appears to be chance, rather than the considered judgment and evaluation of the transferring CNA, who stated that she “knows there needs to be 2 people.”  CMS Ex. 6 at 2. 

CMS has put forth sufficient evidence to establish substantial noncompliance with 42 C.F.R. § 483.25(d) with respect to Resident 161.  Petitioner has not presented sufficient evidence to rebut CMS’s prima facie case.  When one CNA transferred Resident 161 from bed to wheelchair by Hoyer lift, contrary to the resident’s assessment and care plan, Petitioner failed to take all reasonable steps to ensure that the resident received the supervision needed to mitigate the foreseeable risk of harm she faced during the transfer.  Briarwood, DAB No. 2115 at 11; see also Golden Living Ctr. - Riverchase, DAB No.

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2314 at 20 (2010) (“Nonetheless, we also conclude that Petitioner's failure to use the mechanical lift required by R. 8’s care plan on February 26, 2007 constituted immediate jeopardy.”).  Therefore, Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(d) with respect to Resident 161.5

Resident 201

Petitioner argues that Resident 201’s fall on December 30, 2017, was unavoidable.  Petitioner asserts that Resident 201 was to be supervised during Activities of Daily Living, but required only “as needed” supervision at other times given her ability to balance and stabilize without staff assistance.  Petitioner contends that the resident did not require supervision at all times when ambulating.  Petitioner maintains that the accident area was free of hazards and that the resident’s fall was an unforeseeable accident, for which Petitioner was not at fault.  Petitioner asserts that Resident 201 had never fallen at the facility before December 30, 2017, and that there is no basis for a regulatory violation.  P. Br. at 11-13. 

CMS’s citation of regulatory deficiency in the SOD states that Resident 201 requires assistance during ambulation with a walker “at all times.”  CMS Ex. 9 at 33.  CMS also states that Resident 201 had “dementia and was legally blind” and that Petitioner’s DON was unable to provide evidence of “visual checks.”  CMS Ex. 9 at 35. 

Contrary to CMS’s position, as discussed earlier, the optometrist consult note expressly refutes CMS’s assertion that the resident was legally blind and states that the resident used a magnifying glass for reading, due to macular degeneration in one eye only.  Further, the record contains evidence that Resident 201 had received physical and occupational therapy, and that restorative nursing walks showed Resident 201’s ability to ambulate well with a fww and only minimal assistance for a year preceding the fall.  Merely because Petitioner’s restorative nursing staff accompanied Petitioner on daily maintenance ambulation for 70‑80 feet with a fww does not mean that Resident 201 required visual checks or direct supervision at all times while in her room.  See P. Ex. 8 ¶ 6; P. Ex. 9 ¶ 6 (medical expert and medical director opinions that Resident 201’s only fall was unavoidable). 

However, because the record regarding this resident is not entirely clear, I decline to conclude whether the situation involving Resident 201 supports the finding of substantial

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noncompliance.  Because the evidence with regard to Residents 223 and 161 is clear and fully supports the cited deficiency, further analysis of Resident 201 is unnecessary.  

5. The $10,000 per-instance CMP that CMS imposed is reasonable.

CMS imposed a single per-instance CMP in the amount of $10,000 on Petitioner.  P. Ex. A at 2.  When determining whether a CMP amount is reasonable, I apply the factors listed in 42 C.F.R. § 488.438(f):  1) the facility’s history of noncompliance; 2) the facility’s financial condition; 3) the factors specified in 42 C.F.R. § 488.404; and 4) the facility’s degree of culpability, which includes neglect, indifference, or disregard for resident care, comfort, or safety.  See 42 U.S.C. §§ 1320a-7a(d)(2), 1395i-3(h)(2)(B)(ii)(I).  The absence of culpability is not a mitigating factor.  42 C.F.R. § 488.438(f).  The factors listed in 42 C.F.R. § 488.404 include:  1) the scope and severity of the deficiency; 2) the relationship of the deficiency to other deficiencies resulting in noncompliance; and 3) the facility’s prior history of noncompliance in general and specifically with reference to the cited deficiencies.  See 42 U.S.C. §§ 1320a-7a(d)(1), (3), 1395i-3(h)(2)(B)(ii)(I). 

The regulations leave the decision regarding the choice of remedy to CMS, and the amount of the remedy to CMS and the ALJ, requiring only that the regulatory factors at §§ 488.438(f) and 488.404 be considered when determining the amount of a CMP within a particular range.  42 C.F.R. §§ 488.408, 488.408(g)(2); 498.3(d)(11); see also 42 C.F.R. § 488.438(e)(2) and (3); Alexandria Place, DAB No. 2245 at 27 (2009); Kenton Healthcare, LLC, DAB No. 2186 at 28-29 (2008).  However, unless a facility contends that a particular regulatory factor does not support the CMP amount, an ALJ must sustain it.  Coquina Ctr., DAB No. 1860 (2002). 

In the present matter, Petitioner challenges the imposition of the CMP as “unreasonable, inappropriate, and legally unsubstantiated.”  P. Br. at 14.  Petitioner essentially argues that there was no basis for finding substantial noncompliance under Tag F689 as to Residents 223, 161, and 201, and that CMS failed to consider required regulatory factors.  Petitioner does not argue that any specific regulatory factor supports a reduction or elimination of the CMP as unreasonable.  P. Br. at 14-15.

CMS asserts that its penalty amount is reasonable based on Petitioner’s noncompliance.  In support, CMS notes that the $10,000 amount is far less than the maximum permissible per-instance penalty amount of nearly $21,000.  CMS also indicates that Petitioner has a history of deficiencies, and this case involves actual harm.  CMS Br. at 10-11. 

As discussed above, I have determined that Petitioner was noncompliant with 42 C.F.R. § 483.25(d) (Tag F689) with respect to Residents 223 and 161.  CMS had a basis for imposing the CMP as a remedy for the noncompliance.  Petitioner’s general argument to the contrary is without merit.

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Although Petitioner has not disputed any of the factors related to the CMP amount, I discuss those factors because I did not reach a conclusion as to whether Petitioner was noncompliant based on Resident 201. 

Facility’s History of Non-Compliance:  Petitioner has a history of noncompliance, both with deficiencies identified in the instant case and more generally over prior years.  From 2005 through 2017, Petitioner failed to be in substantial compliance with a total of 32 program requirements for surveys conducted in 2005, 2008, 2009, 2010, 2012, 2013, 2016, and 2017.  CMS Ex. 8.  The 2009 survey included a deficiency under Tag F323, the predecessor to the tag at issue in this case, Tag F689.  CMS Ex. 8 at 2-3.  All of these previous deficiencies were at the scope and severity levels of D, E, and F (isolated, pattern, and widespread deficiencies with no actual harm to residents, but the potential for more than minimal harm), and CMS allowed Petitioner to correct the deficiencies without imposing an enforcement remedy.  CMS Ex. 8.  This history supports CMS’s imposition of a mid-range CMP amount.  Although Petitioner does not have a history of deficiencies involving actual harm, Petitioner has consistently failed to be in substantial compliance with all requirements. 

Scope and Severity of Deficiencies and Relationship Between Deficiencies:  This case primarily involves actual harm to Resident 223 consisting of a fractured left hip and a five-day inpatient hospitalization for acute inpatient care and surgical repair.  Although Petitioner’s conduct in relation to Resident 161 did not involve actual harm, this incident is related to the one with Resident 223 in that they both evidenced a failure to follow care plan interventions meant to ensure residents did not fall.  Again, this factor supports a substantial CMP amount. 

Culpability:  I conclude that Petitioner is very culpable in this case.  Petitioner assessed Resident 223 as a high fall risk and unable to ambulate unassisted.  Resident 223 had a history of trying to ambulate on her own and had fallen multiple times in her room at the facility.  Petitioner’s care plan quite reasonably called for Resident 223 not to be left unattended.  Yet, in spite of all of this, Petitioner’s staff left her unattended.  However, unlike the many previous falls at the facility, this fall resulted in significant injury that only surgery could repair.  Following Resident 223’s return to the facility, she fell again. 

With respect to Resident 161, Petitioner’s staff created an accident risk due to inadequate supervision, by failing to follow the resident’s care plan and have two employees participate in the Hoyer lift transfer of Resident 161 from bed to wheelchair. 

I find it particularly troubling that Petitioner does not comply with its own safety interventions in the residents’ care plans.  Petitioner’s culpability is very high.  Although I did not conclude that Petitioner was deficient in regard to Resident 201, Petitioner’s culpability related to Residents 223 and 161 are sufficient to justify the CMP amount CMS imposed.

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

CMP Amount:  A per-instance CMP of $10,000 in the middle of the penalty range is entirely reasonable based on the factors considered above. 

VI.  Conclusion

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 $10,000 per‑instance CMP is reasonable.

• 1. All citations to the Code of Federal Regulations are to the version in effect at the time of the survey unless otherwise indicated.
• 2. Although the state agency cited Petitioner with multiple deficiencies, CMS based the imposition of a CMP solely on the deficiency under 42 C.F.R. § 483.25(d).  P. Ex. A at 2; see CMS Br. at 1 (additional cited violations did not lead to imposition of remedy and are not at issue).  I may only review deficiencies that are the basis for the imposition of an enforcement remedy.  42 C.F.R. §§ 488.408(g)(1), 498.3(b)(13).  Therefore, I confine my discussion in this decision to the deficiency cited by the state agency under 42 C.F.R. § 483.25(d) (Tag F689) at scope and severity level “G.”
• 3. At all times relevant to this proceeding, Petitioner had in place a “Fall Management Program,” which included resident fall risk assessments for fall prevention, interventions as part of resident care plans, post-fall assessments, and staff training. CMS Ex. 2. Petitioner’s “Fall Risk Assessment” policy includes the CMS definition of “fall” as “unintentionally coming to rest on the ground, floor, or other lower level [without] overwhelming external force.” CMS Ex. 2 at 8. The policy further states that “[a] fall without an injury is still a fall” and “[u]nless there is evidence otherwise, when a resident is found on the floor, a fall is considered to have occurred.” CMS Ex. 2 at 8.
• 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).
• 5. Petitioner points out that Resident 161 was not actually harmed and that this is inconsistent with the scope and severity level G assigned to this deficiency. However, the incident with Resident 161 can still serve as evidence that Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(d). In this case, I cannot review the scope and severity level found by CMS because it would not affect the range of penalties that CMS could impose in this case. 42 C.F.R. § 498.3(b)(14).