Generations at Elmwood Park, DAB CR6227 (2023)

DECISION

In 2021, Resident 1 (R1) was a resident at Generations at Elmwood Park (Petitioner or facility), a skilled nursing facility (SNF).  R1 was elderly, deaf, mute, extremely weak due to a stroke, and diagnosed with severe osteoarthritis and osteopenia.  R1’s care plan required Petitioner’s staff to provide “maximum assistance” for activities of daily living (ADL), and for two staff members to assist R1 with bed mobility.  Despite this, Petitioner’s staff often provided R1 with a one-person assist for bed mobility and for changing R1’s clothes in bed. 

On May 13, 2021, R1 began complaining of pain (six on a scale of one to ten) in R1’s left leg after a single certified nurse assistant (CNA) changed R1’s clothing in bed.  An x-ray indicated that R1 had an impacted facture of the distal femur.  R1 was admitted to an acute care hospital on May 14, 2021, which confirmed the impacted distal femur fracture. 

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

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and adequate supervision.  CMS agreed with the state agency that the deficiency resulted in actual harm to one of the facility’s residents.  CMS imposed an $11,715 per-instance civil money penalty (CMP) on Petitioner. 

Petitioner sought review of CMS’s determination.  Petitioner argues that R1 did not always require a two-person assist with bed mobility and while being changed in bed because R1 was able to assist staff by holding bedrails.  Petitioner also argues that CMS failed to prove causation (i.e., failed to provide any evidence that R1’s fracture was caused by facility staff action or inaction).  Petitioner further argues that R1’s fracture was pathological and unavoidable due to R1’s osteopenia and severe osteoarthritis. 

As I explain below, I conclude that CMS provided prima facie evidence that Petitioner was noncompliant with 42 C.F.R. § 483.25(d) because Petitioner failed to provide care to R1 in accordance with R1’s care plan when it was foreseeable that R1 could be subject to accidental harm due to R1’s osteopenia and osteoarthritis.  Although I have no jurisdiction to review CMS’s finding of actual harm, the record as a whole (i.e., the chronology of events and opinions of Petitioner’s Director of Nursing (DON) and the orthopedic surgeon who treated R1’s fracture) supports this conclusion.  In any event, the record supports CMS’s finding that Petitioner’s failure to comply with the care plan for bed mobility and maximum ADL assistance had the potential for causing more than minimal harm to R1.  Therefore, I sustain CMS’s charge that Petitioner was noncompliant with 42 C.F.R. § 483.25(d) and conclude that the CMP amount imposed was appropriate under relevant statutory and regulatory factors. 

I.  Legal Framework

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

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

In addition to complying with the terms of the provider agreement, a participating SNF must meet a variety of ongoing statutory requirements regarding how it provides services, maintains the rights of its residents, and administers its facility.  42 U.S.C. § 1395i-3(a)(3), (b)-(d).  Further, SNFs must comply with “such other requirements relating to the

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health, safety, and well-being of residents or relating to the physical facilities thereof as the Secretary may find necessary.”¹  42 U.S.C. § 1395i-3(d)(4)(B); see 42 U.S.C. § 1395i-3(c)(1)(xi), (f).  The Secretary has promulgated regulations to establish those additional requirements.  See 42 C.F.R. pt. 483, subpt. B.²   

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 comprises 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 has the duty to enforce the statutory and regulatory participation requirements for SNFs.  42 U.S.C. § 1395i-3(f)(1).  To do so, the Secretary contracts with state agencies to conduct surveys to determine whether SNFs are in substantial compliance.  42 U.S.C. §§ 1395aa(a), 1395i-3(g); 42 C.F.R. § 488.10.  Standard surveys are unannounced and occur at least once every 15 months.  42 U.S.C. § 1395i-3(g)(2)(A)(i), (iii)(I).  State agencies also conduct investigations into complaints against SNFs.  42 U.S.C. § 1395i-3(g)(1)(C), (4).  When the results of a survey show that an SNF is not in substantial compliance with program participation requirements, the Secretary may impose enforcement remedies on the SNF.  42 U.S.C. § 1395i-3(h)(2); 42 C.F.R. § 488.406.  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

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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 January 17, 2020, and for deficiencies that occurred after November 2, 2015, the CMP amounts may range as follows:  $2,233 to $22,320 for per-instance CMPs; $112 to $6,659 per day for less serious noncompliance; or $6,808 to $22,320 per day for more serious noncompliance that poses immediate jeopardy to the health and safety of residents.  45 C.F.R. § 102.3 (2020); 85 Fed. Reg. 2869, 2870, 2880 (Jan. 17, 2020); 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 such a showing is made, the SNF must then prove substantial compliance by a preponderance of the evidence.  Hillman Rehab. Ctr., DAB No. 1611 at 8 (1997); see Batavia Nursing & Convalescent Inn, DAB No. 1911 (2004); Batavia Nursing & Convalescent Ctr., DAB No. 1904 (2004), aff’d, Batavia Nursing & Convalescent Ctr. v. Thompson,129 F. App’x 181 (6th Cir. 2005); Emerald Oaks, DAB No. 1800 (2001).  If an SNF challenges CMS’s determination as to the level of noncompliance, CMS’s determination must be upheld unless it is clearly erroneous.  42 C.F.R. § 498.60(c)(2). 

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

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

II.  Background and Procedural History

Petitioner is an SNF that operates in Elmwood Park, Illinois.  On May 21, 2021, surveyors from the state agency completed investigations into three complaints filed against Petitioner.  CMS Ex. 4.  The state agency subsequently issued a Statement of

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Deficiencies (SOD).  The SOD stated that there were no deficiencies based on two of the complaints.  However, the SOD indicated that the investigation into the third complaint yielded evidence of noncompliance with 42 C.F.R. § 483.25(d) (Tag F-689) (i.e., free of accident hazards/supervision and assistive devices to prevent accidents) at scope and severity “G” (i.e., isolated deficiency constituting actual harm that is not immediate jeopardy) related to one resident (R1).  CMS Ex. 4 at 1. 

Due to this deficiency finding, the state agency issued a notice of initial determination on June 7, 2021, imposing a denial of payment for new admissions (DPNA), effective June 22, 2021, if Petitioner failed to achieve substantial compliance by that date.  CMS Ex. 1 at 1-2.  The state agency also recommended that CMS impose a CMP.  CMS Ex. 1 at 2. 

On October 28, 2021, CMS issued a notice of an initial determination adopting the state agency survey findings in the SOD and imposing an $11,715.00 per-instance CMP on Petitioner.  CMS Ex. 2 at 1-2.  CMS also explained that a revisit survey at Petitioner’s facility confirmed that Petitioner had returned to substantial compliance as of June 9, 2021; therefore, the DPNA did not go into effect.  CMS Ex. 2 at 1.  Finally, CMS stated that Petitioner would be prohibited from operating a Nurse Aide Training and Competency Evaluation Program (NATCEP) because the CMP imposed was more than $11,160; however, CMS noted that if the CMP amount was reduced on appeal below $11,160, then the prohibition on a NATCEP would end.  CMS Ex. 2 at 4. 

On December 27, 2021, Petitioner requested a hearing before an ALJ to dispute the October 28, 2021 initial determination.  On January 5, 2022, the Civil Remedies Division (CRD) issued my Standing Prehearing Order (SPO).  In the SPO, 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 SPO, CMS filed an exchange, including a combined motion for summary judgment and prehearing brief (CMS Br.) and 14 proposed exhibits (CMS Exs. 1-14), which included written direct testimony from one proposed witness.  Petitioner filed an exchange consisting of a prehearing brief (P. Br.), 4 proposed exhibits (P. Exs. 1‑4), and no proposed witnesses.  Petitioner also filed objections to two of CMS’s proposed exhibits. 

CMS waived its right to file a reply brief. 

III.  Admission of Exhibits into the Record

I admit Petitioner’s four proposed exhibits into the record, without objection from CMS.  I also admit all of CMS’s proposed exhibits into the record.  Below I explain why I overrule Petitioner’s objection to two of CMS’s exhibits.

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Petitioner objected to CMS Exhibits 11 and 12.  Those documents contain the state agency surveyor’s investigation notes, including notes of interviews of Petitioner’s staff and an orthopedist who treated R1.  Petitioner objected that the notes contain inadmissible hearsay and may not accurately record what was said at the interviews. 

In these proceedings, I am to receive into evidence any testimony and documents that are relevant and material.  42 C.F.R. § 498.60(b)(1).  Further, I may receive evidence even if it is inadmissible under the rules of evidence applicable to the courts.  42 C.F.R. § 498.61.  Further, the Administrative Procedure Act provides:  

Any oral or documentary evidence may be received, but the agency as a matter of policy shall provide for the exclusion of irrelevant, immaterial, or unduly repetitious evidence.  A sanction may not be imposed or rule or order issued except on consideration of the whole record or those parts thereof cited by a party and supported by and in accordance with the reliable, probative, and substantial evidence. 

5 U.S.C. § 556(d).  Therefore, the primary test for the admission of evidence is whether it is relevant and material to an issue in the case.  However, the ALJ’s decision must turn on reliable, probative, and substantial evidence.  

I find that the surveyor’s notes are relevant to this proceeding.  Further, as testified to by the surveyor, CMS Exhibits 11 and 12 are “[t]rue and accurate copies of the notes that [I] took during the survey, which truly and accurately document [my] interviews, record review, and observations.”  CMS Ex. 10 ¶ 3.  Thus, CMS Exhibits 11 and 12 reflect government records created by the surveyor that have been authenticated. 

Petitioner’s hearsay objections are unavailing because the formal rules of evidence do not apply in this case.  As to the accuracy of the interviews, all but one of the interviewees (the orthopedic surgeon) appear to be Petitioner’s employees, and Petitioner was free to ascertain whether each employee agreed or disagreed with the interview notes.  Petitioner also could have obtained written direct testimony from the employees to either dispute or clarify the interview notes.  Petitioner did not submit any written testimony from its employees; therefore, the accuracy of the interview notes has not been contested.  Regarding the notes from the surveyor’s interview with the orthopedic surgeon, Petitioner could have attempted to verify the accuracy of the interview notes and, if Petitioner was unable to communicate with the orthopedic surgeon, could have requested a subpoena for the surgeon to testify at an oral hearing.  SPO ¶ 8; 42 C.F.R. § 498.58. 

Therefore, I overrule Petitioner’s objections and admit all of CMS’s proposed exhibits into the record. 

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IV.  Decision on the Record

I directed the parties to submit written direct testimony for all witnesses that they wanted to testify in this proceeding and stated that an in-person hearing would only be necessary if a party requested to cross-examine a witness.  SPO ¶¶ 10-12; CRD Procedures §§ 16(b), 19(b). 

Petitioner did not submit written direct testimony from any witnesses.  CMS submitted written direct testimony for one witness.  Petitioner’s filing was ambiguous as to whether it wanted to cross-examine CMS’s witness.  On May 9, 2022, CRD staff sent an email giving Petitioner’s counsel until May 11, 2022, to explicitly state whether Petitioner wanted to cross-examine CMS’s witness or else I would assume Petitioner did not want to do so.  E-Filing System (E-File) Document No. 23.  Petitioner’s counsel never responded to the email.³   

I decide this case based on the written record because Petitioner did not request to cross-examine the only witness in this case.  SPO ¶ 13; CRD Procedures § 19(d).  

V.  Issues

1. Whether Petitioner was in substantial compliance with the requirements of 42 C.F.R. § 483.25(d) (Tag F-689) (scope and severity “G”), relating to accident prevention and adequate supervision; and

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2. If Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(d), whether the $11,715 per-instance CMP is appropriate under applicable statutory and regulatory factors. 

CMS sought to add a second deficiency finding against Petitioner in its prehearing brief.  Specifically, using the same basic facts in this case, CMS charged that Petitioner violated the requirements in prefatory text to 42 C.F.R. § 483.25.  CMS Br. at 2 n.1.  I do not authorize this to be a new issue in this case.  See 42 C.F.R. § 498.56(a) (granting ALJs discretion to allow new issues to be added to an adjudication).  CMS merely used the general requirements in the prefatory text of § 483.25 in support of the § 483.25(d) deficiency rather than discussing it as a completely separate deficiency.  CMS Br. at 5-10.  In such a circumstance, CMS does not need to add § 483.25 as a separate deficiency because the introductory language to § 483.25 already applies to each of the subsections in that section, including the accident prevention provisions in § 483.25(d).  Buena Vista Care Center, DAB No. 2498 at 15-16 (2013). 

VI.  Findings of Fact and Conclusions of Law

1. R1 was a non-ambulatory resident at Petitioner’s facility who was diagnosed with left side hemiplegia, severe osteopenia, severe osteoarthritis, dementia, and other medical issues.  Petitioner’s care plan in effect in May 2021 required two staff members to assist R1 with bed mobility.  It also required staff to provide R1 with “maximum assistance” with ADLs.  A Minimum Data Set (MDS) assessment and Restorative Assessment for R1 in March 2021 provided findings mostly consistent with the care plan’s requirements.  Petitioner did not modify the care plan based on the results of those assessments.

R1 was admitted to Petitioner’s facility in 2007.  CMS Ex. 9 at 1.  In the spring of 2021, R1 was an 87-year-old woman who had diagnoses that included:  a history of cerebral vascular accident (i.e., stroke) with residual left hemiplegia and dysphagia; severe osteoarthritis; severe osteopenia; unspecified disorders involving bone density and structure; muscle weakness; lack of coordination; cognitive communication deficit; deafness; and dementia.  CMS Ex. 9 at 1-2, 6, 20, 25; CMS Ex. 11 at 9. 

In 2015, Petitioner identified “Falls” as a “Problem” for R1 and added an entry to R1’s care plan on this topic.  An intervention for this “Problem,” which was commenced in 2015, was to use a Hoyer lift for transfers.  On September 18, 2018, the following intervention was added to the care plan:  “Provide two person assist with bed mobility.”  CMS Ex. 7 at 1. 

On December 29, 2020, Petitioner identified the following “Problem” for R1:  “[R1]  requires supervision and set up for ADL’s [sic] related to LEFT SIDED HEMIPLEGIA.”  CMS Ex. 7 at 4.  One of the interventions initiated on December 29, 2020, was:  “Provide

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maximum assistance during [ADLs] (e.g., range of motion, bed mobility, transfers, wheelchair mobility).”  CMS Ex. 7 at 4-5. 

On March 10, 2021, Petitioner’s staff conducted an MDS assessment of R1.  The assessment concluded that: 

• R1 was impaired on both sides in R1’s upper and lower extremities;  

• R1 had “Total dependence” on staff for bathing and transferring in and out of the tub or shower;  

• R1 needed “Extensive assistance” from staff and needed “Two+ persons physical assist” for bed mobility (i.e., “how resident moves to and from lying position, turns side to side, and positions body while in bed or alternative sleep furniture”);

• R1 had “Total Dependence” on staff and needed “Two+ persons physical assist” for transfers (i.e., “how resident moves between surfaces including to and from:  bed, chair, wheelchair, standing position (excludes to/from bath/toilet)”);

• R1 needed “Extensive assistance” from staff and needed “One person physical assist” for dressing (i.e., “how resident puts on, fastens and takes off all items of clothing, including donning/removing a prosthesis or TED hose.  Dressing includes putting on and changing pajamas and housedresses”); and  

• R1 had “Total Dependence” on staff and needed “Two+ persons physical assist” for toilet use. 

CMS Ex. 8. 

On March 23, 2021, Petitioner’s staff conducted a Restorative Assessment of R1.  The Assessment stated that R1 needed the following in regard to putting clothes on and taking them off:  upper body was extensive assistance; lower body was total assistance; and fasteners were total assistance.  CMS Ex. 6 at 2-3.  R1 was assessed as dependent for putting socks and shoes on and off.  CMS Ex. 1 at 2-3.  R1 needed extensive assistance to roll supine to left side and back to supine and to roll from supine to right side back to supine.  CMS Ex. 6 at 1.  R1 needed total assistance from supine to sit, from sit to supine, and when moving up and down in the bed.  CMS Ex. 6 at 1.  R1 had 1/4 bilateral rails as assistive devices.  CMS Ex. 6 at 1. 

The restorative assessment also evaluated R1’s range of motion in both of R1’s upper and lower extremities.  R1 had a noted impairment on one side in R1’s upper extremities and an impairment on both sides in R1’s lower extremities.  R1 had no noted hip fracture, hip

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replacement, knee replacement or decreased sensation at the time of the assessment on March 23, 2021.  CMS Ex. 6 at 5.  A restorative nurse who conducted the assessment entered the following progress note: 

Resident alert and oriented to self.  Non-verbal and deaf.  She tries to make hand gestures.  Able to follow with visual cues during non-assessment, noted limited joint mobility and contractures.  Left shoulder severe limited . . . [r]esident receives physical assist with bed mobility able to utilize side rails for support . . . continue receiving extensive to total assist with bed mobility . . . dressing . . . .

CMS Ex. 6 at 6.

2. Immediately after lunch, on May 13, 2021, a single CNA changed R1 in bed.  R1 indicated to the CNA that R1’s left leg was in pain.  R1 indicated to Petitioner’s staff that R1’s pain was a six on a scale of one to ten.  Petitioner’s staff took an x-ray, which showed a nondisplaced, impacted distal femur fracture.  R1 was sent to an acute care hospital on May 14, 2021.  The orthopedist at the hospital diagnosed R1 as having a nondisplaced, impacted distal femur fracture.

On May 13, 2021, a single CNA (designated in the complaint investigation as V11) changed R1’s clothes immediately after lunch.  V11 noticed that R1 had been fine in the morning, but after changing R1, V11 could tell that R1 was uncomfortable.  R1 kept pointing to the lower half of R1’s body.  But V11 stated that R1 was neither harmed nor hit R1’s leg during the changing of R1’s clothing.  V11 informed a nurse of this situation.  CMS Ex. 10 ¶ 12; CMS Ex. 11 at 8. 

A licensed practical nurse (designated as V5 in the complaint investigation) assessed R1.    V5 wrote a progress note on May 13, 2021, at 1:23 p.m. in which V5 stated that R1 complained of lower extremity pain at a level of six on a scale of one to ten.  V5 gave R1 Tylenol and, within an hour, R1’s pain was reduced to a two out of ten.  A nurse practitioner ordered Tylenol to be given as needed to R1.  V5 thought that it was not like R1 to be in this much pain, but R1 did not have swelling or bruising anywhere on R1’s body.  However, V5 noticed that as the Tylenol would wear off, R1 would go from smiling to being in pain.  CMS Ex. 9 at 28; CMS Ex. 11 at 8. 

According to a progress note written by V5 at 3:02 p.m. on May 13, 2021, a nurse practitioner ordered an x-ray of R1’s lower extremities.  CMS Ex. 9 at 28; CMS Ex. 11 at 8. 

Two CNAs who work on R1’s floor (designated as V3 and V4 in the complaint investigation) were on duty the night of May 13, 2021.  They went together to change R1

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and observed R1 grunting and pointing to R1’s leg.  According to V4, R1 nodded when asked if R1 had pain and pointed to R1’s leg.  V3 and V4 did not change R1 due to the pain.  CMS Ex. 11 at 1-2; see CMS Ex. 10 ¶ 9. 

According to a progress note written at 1:30 a.m. on May 14, 2021, the x-ray results were received at approximately midnight, which indicated a “possible distal femur fracture.”  CMS Ex. 9 at 28.  A progress note entered on 8:17 a.m. on May 14, 2021, indicated that a nurse practitioner sent R1 to West Medical Center to rule out a left femur distal fracture.  CMS Ex. 9 at 28. 

The physician at the medical center ordered another x-ray, which “confirmed nondisplaced, impacted fracture of the distal femur.”  CMS Ex. 9 at 20-22, 24-25.  The medical center recorded that there was “[u]nclear etiology” for the fracture and that Petitioner’s facility was “unable to specify if fall had occurred.”  CMS Ex. 9 at 22.  

An orthopedic consultation note indicated that, while R1 was nonverbal, R1 “is in distress when attempting to examine her leg.”  CMS Ex. 9 at 23.  The orthopedist (designated as V13 in the complaint investigation) determined that R1’s leg aliment was acceptable and prescribed “[k]nee immobilizer at all times except when bathing.  No acute ortho intervention.”  CMS Ex. 9 at 23.  Further, other notes from the hospital indicated that the plan for R1 was “to discharge to nursing home after immobilization of left knee.  [Physical therapy/occupational therapy] for further evaluation.”  CMS Ex. 9 at 22.  R1 was discharged from West Medical Center and readmitted to the facility on May 15, 2021.  CMS Ex. 9 at 27.  A facility progress note authored on R1’s return noted that R1 had discoloration to R1’s lower legs, but was alert, in stable condition, and had no signs of distress.  CMS Ex. 9 at 27. 

Based on the evidence discussed above, I find that R1’s pain related to the nondisplaced, impacted fracture of the distal femur commenced on May 13, 2021, after V11 changed R1 following lunch on May 13, 2021.  In doing so I resolve some potentially inconsistent evidence below.  

There is a progress note in the record, written by a nurse (designated as V10 in the complaint investigation) at 2:34 p.m. on May 12, 2021, in which V10 states that a nurse practitioner conducting a vascular consultation assessment reported that R1 had bilateral extremity pain at a level of six out of ten.  The pain level was assessed by R1’s facial grimacing, as observed by the nurse practitioner.  V10 then assessed R1 but noticed that R1 did not complain of any pain, even when V10 repositioned R1.  In a progress note that V10 authored at 2:56 p.m. on May 12, 2021, the nurse practitioner ordered, among other things, an x-ray of R1’s legs.  In a progress note authored by V10 at 9:40 p.m. on May 12, 2021, V10 noted that R1 refused the x-ray, even after V10 explained the benefits of the test.  CMS Ex. 9 at 26, 28; CMS Ex. 11 at 7. 

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I find that this incident on May 12, 2021, is not connected with the pain exhibited by R1 at mid-day on May 13, 2021.  Although the nurse practitioner conducting a vascular consultation indicated that R1 grimaced with pain when touching R1’s legs, V10 could not corroborate this with R1.  Even repositioning did not cause R1 pain.  R1 also refused the x-ray of R1’s lower extremities, which R1 did not refuse on the evening of May 13.  It is significant that the orthopedist who examined R1 on May 13, 2021, stated that “[R1] would have been in pain immediately after [the nondisplaced, impacted fracture of the distal femur] occurred and then probably any time she moved her leg after that.”  CMS Ex. 11 at 9.  V10’s observations, especially after repositioning R1, strongly suggest that R1 did not yet have the fracture on May 12, 2021. 

The only evidence in the record to connect the May 12, 2021 observation of pain with R1’s indication of pain following changing at mid-day on May 13, 2021, is an interview statement from V5.  V5 said that R1 was in pain on the morning of May 13, 2021, and that the nurse practitioner “just told me to give her some Tylenol.”  CMS Ex. 11 at 3; see CMS Ex. 10 ¶ 9.  I find that V5’s recollection was mistaken as to the time of day that V5 saw that R1 was in pain.  In the progress notes authored by V5, V5 indicated that R1 was in pain in the afternoon and that Tylenol was ordered and administered.  CMS Ex. 9 at 28.  Further, V11, who changed R1 immediately after lunch, stated that R1 had been fine in the morning and showed no signs of problems during changing.  CMS Ex. 11 at 8.  As stated above, the orthopedist said that once R1’s leg was fractured, R1 would have been in pain any time R1 moved the leg after that.  V3 and V4 reported exactly this on the night of May 13 when attempting to change R1.  CMS Ex. 11 at 1-2.  But, as already stated, V11 said that R1 had no problems during changing at mid-day following lunch. 

3. Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(d)(Tag F-689) because the facility did not take all reasonable steps to provide the supervision and assistance necessary to prevent a femur fracture to R1’s left leg. Due to the facility’s failure in providing adequate weight-bearing support with a two-person assist during bed mobility and in failing to provide total assistance while changing R1’s lower body on March 12, 2021, as required by R1’s Care Plan, Petitioner placed R1 at risk 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) (emphasis added).  In furtherance of this mandate, the Secretary promulgated the general quality of care regulation at 42 C.F.R. § 483.25, which states in that section’s prefatory text 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.  Paragraph (d) of § 483.25 imposes specific obligations on a facility

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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, § 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 § 483.25(d) “come into play when there are conditions in a facility that pose a known or foreseeable risk of accidental harm.” Meridian Nursing Ctr., DAB No. 2265 at 9 (2009), aff’d sub. nom. Fal Meridian, Inc. v. U.S. Dep’t of Health & Human Servs., 604 F.3d 445 (7th Cir. 2010). Further, § 483.25(d)(2) requires that a facility take “all reasonable steps to ensure that a resident receives supervision and assistance devices that meet his or her assessed needs and mitigate foreseeable risks of harm from accidents.” Briarwood Nursing Ctr., DAB No. 2115 at 11 (2007) (citing Woodstock Care Ctr. v. Thompson, 363 F.3d 583, 590 (6th Cir. 2003) (facility must take “all reasonable precautions against residents’ accidents”), aff’g Woodstock Care Ctr., DAB No. 1726 (2000)). Facilities are given “the flexibility to choose the methods” they use to provide supervision or assistive devices to prevent accidents, so long as the chosen methods “constitute an ‘adequate’ level of supervision” for a particular resident’s needs. Windsor Health Care Ctr., DAB No. 1902 at 5 (2003), aff’d sub. nom. Windsor Health Ctr. v. Leavitt, 127 F. App’x 843 (6th Cir. 2005).

In the present case, CMS asserts that R1’s femur was fractured while being changed in bed during a one-person assist, contrary to the assistance requirements described in R1’s comprehensive person-centered care plan.  CMS submits R1’s care plan, a March 2021 MDS assessment, and a March 2021 restorative assessment to show that both extensive and total assistance were required for bed mobility and for ‘on’ and ‘off’ changing for R1.  Further, CMS relies on statements made by facility staff during survey interviews to

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suggest that R1 was fractured while being changed in bed in the afternoon on May 13, 2021, by a single CNA.  While CMS acknowledges it cannot absolutely prove that the use of a single person to change R1, instead of two, caused the fracture, CMS argues that it does not have to prove causation because Petitioner’s use of one person to change R1 in bed resulted in the deficiency.  CMS Br. at 9-10. 

Petitioner neither disputes that a single CNA changed R1 in bed shortly before R1 indicated discomfort nor that R1 was diagnosed with a nondisplaced, impacted fracture of the distal femur.  Petitioner primarily argues that CMS lacks proof for the causation of R1’s fracture and that proof of harm is needed to support a deficiency under 42 C.F.R § 483.25(d)(1),(2).  P. Br. at 9-10.  Moreover, Petitioner argues that a two-person assist was unnecessary and that CMS’s reliance on the MDS assessment to support the deficiency is misplaced because the MDS “does not reflect R1’s day to day needs or the staff support needed for a given task, but [is] rather an assessment based on what actually occurred during a ‘look back period.’”  P. Br. at 7.  Petitioner accepts that the restorative assessment and the care plan respectively state that extensive assistance and maximum assistance were needed when moving R1 but argues that neither of these documents always required a two-person assist for R1 during bed mobility or while changing.  P. Br. at 8-9.  Further, Petitioner argues that CMS presented no evidence that R1 was injured by facility staff action or inaction, and there is no evidence that R1 was moved in a manner inconsistent with R1’s plan of care.  P. Br. at 7-11.  Lastly, Petitioner asserts that R1’s fracture was “pathological in nature due to severe osteopenia and not the result of any improper care received at the Facility.”  P. Br. at 6. 

As discussed more fully below, I conclude that CMS provided sufficient evidence to meet its burden of showing a prima facie case for a deficiency (i.e., the potential for causing more than minimal harm).  Hillman, DAB No. 1611 at 8.  While CMS concluded that Petitioner’s deficiency constituted actual harm to R1 (see 42 C.F.R. § 488.404(b)(1)(iii)), I cannot review the level of noncompliance found by CMS unless a successful challenge to that level could affect the range of CMP amounts that CMS could collect based on the deficiency.  42 C.F.R. § 498.3(b)(14)(i).  In this case, CMS imposed a per-instance CMP, which only has one range of CMP amounts.  42 C.F.R. § 488.438(a)(2).  Therefore, in order to prevail, CMS only needed to make a prima face showing that a violation of Medicare program requirements posed a potential for more than minimal harm to a resident. 

To make its prima facie case, CMS submitted R1’s care plan, which provides two interventions that are highly relevant.  A December 29, 2020 problem of left sided hemiplegia indicates that, starting on December 29, 2020, Petitioner’s staff was to “[p]rovide maximum assistance during [ADLs] (e.g., range of motion, bed mobility, transfers, wheelchair mobility).”  CMS Ex. 7 at 4-5.  Petitioner disagrees that this intervention means that a two-person assist was always required.  P. Br. at 8.  Petitioner’s interpretation, however, fails to consider that “maximum” indicates the opposite of

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“minimum,” which strongly supports that the approach was intended to provide R1 with assistance by more than one person.  Further, such an interpretation is consistent with the care plan intervention initiated on September 8, 2018, which indicates that staff were to “[p]rovide two person assist with bed mobility.”  CMS Ex. 7 at 1.  The entries, taken together, indicate that Petitioner was to provide a two-person assist when assisting R1 to move around in bed and when providing ADLs.  This interpretation is consistent with the March 2021 rehabilitative assessment indicting that putting on and removing clothing on R1’s lower body required total assistance.⁵    CMS Ex. 6 at 2-3. 

Consistent with the care plan, the state agency investigation revealed that Petitioner’s employees knew that R1 needed two individuals to assist in bed mobility and/or to change R1.  The two CNAs, V3 and V4, who went together to change R1 on the night of May 13, 2021, both indicated that R1 required a two person assist when changing.  CMS Ex. 11 at 1 (“She can’t really help you do anything.  She can’t move her legs and she only moves her arms a little bit so that’s why it’s safer to always used t[w]o people when caring for her.”); CMS Ex. 11 at 2 (“She needs a two person assist to change.  She can’t help you do anything.”).  The nurse who was on duty with V3 and V4 on the night of May 13, 2021, agreed with their assessment concerning the need for a two-person assist.  CMS Ex. 11 at 5 (“She is a two person assist due to being heavier and stiffer.  She can't move her legs at all.”).  Another nurse, V10, stated that, while V10 did not personally change R1, R1 “is changed with two people because she can’t really help out and she isn’t very strong.”  CMS Ex. 11 at 7.  Finally, a rehabilitation aide agreed and stated: 

[R1] needs 2 people always when you are moving or turning her in bed.  She is pretty weak and can’t really help with moving at all.  I mean she can grab the rail but [s]he can’t really hold her weight up.  She is a bigger lady to be having one person try to do everything too.  She can’t really move her legs at all and her left side is her bad side.  You always want 2 people moving her to make sure nothing happens to her when she is being repositioned.  You just want to make sure she is staying safe.

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CMS Ex. 11 at 10.  Even V11, the CNA who changed R1 after lunch on May 13, 2021, indicated that V11’s decision as to whether V11 would change a resident alone was based on the availability of another staff member to assist and by knowing what a resident can physically do.  V11 stated:  “[R1] is a two person transfer I know that.  She is a complete total assist with changing; she can hold the rail but that’s about it . . . .  If I can find someone to help I will call them to help me chang[e] [h]er but I usually do it alone.  There isn't really anything we go off of we just kind of change the residents by knowing them and what they can do.”  CMS Ex. 11 at 8.

Only two individuals indicated one person could change R1.  However, even these statements were either not absolutely clear on this point or relied for their opinion on R1’s supposed ability to assist in the changing.  The Restorative Nurse said that while R1 is a two person assist with transferring, “1 to 2 people can change her.  She can hold the side rail.  Staff does the weight bearing work.”  CMS Ex. 11 at 6.  The DON stated that “[R1] really only need[ed] one person to assist because she can help a little bit.”  CMS Ex. 11 at 4. 

The view that only one person is needed to assist R1 while changing has support in the March 10, 2021 minimum data set (MDS) assessment.  The MDS indicates that, for bed mobility, staff provided “Extensive assistance” by “Two+ persons” during the look back period.  However, for changing clothing, staff provided a one-person assist.  CMS Ex. 8 at 2. 

Interestingly, despite this, Petitioner argues it is improper for CMS to rely on MDS coding for the care and services that R1 needs on a constant, ongoing basis.  Petitioner asserts that the MDS does not reflect R1’s day to day needs or the staff support needed for a given task.  P. Br. at 7-8.  Because the MDS assessment only assessed R1 based on what occurred during a “look back period” from March 1 to March 10, 2021, Petitioner suggests that R1 might have needed more assistance than R1’s true abilities on a given day.  Petitioner surmises that, as a result, R1 did “not automatically need the assistance of two or more staff with bed mobility over all.”  P. Br. at 7.  Therefore, while the MDS assessment may assist Petitioner’s argument that only one individual was needed to assist R1 while changing clothing, Petitioner appears more concerned at discrediting the idea that the MDS shows that a two-person assist was needed for bed mobility. 

To support its position that the MDS should not be used as a measure for the number of people needed to assist R1, Petitioner submitted Petitioner Exhibits 2 and 3, which are excerpts from CMS’s Resident Assessment Instrument (RAI) manual.  The RAI indicates that the facility conducts a two-part ADL evaluation.  The evaluation includes the resident’s self-performance and the need for facility staff support to complete the ADL.  Code 3 is “Extensive Assistance” and is used to indicate that, during the self-performance portion of the evaluation, a resident was involved in performing an ADL, and required either weight-bearing support or full staff performance three or more times.  P. Ex. 2. 

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Petitioner Exhibit 3 provides the following definition for ADL Support Provided:  “measur[ing] the most support provided by staff over the last 7 days, even if that level of support only occurred once.”  The coding instructions listed in the MDS for ADL support state that a code 2 indicates a one-person physical assist was provided and a code 3 indicates a two+ persons physical assist was provided.   CMS Ex. 8 at 2.  Moreover, staff were to “code for most support provided over all shifts, [and] regardless of the resident’s self-performance classification.”  CMS Ex. 8 at 2. 

Lastly, Petitioner submits Petitioner Exhibit 4, a Point of Care History form, which is a chart indicating the support provided by staff for bed mobility for R1, from March 1, 2021 to March 10, 2021.  Petitioner Exhibit 4 indicates that over this 10-day period, a one-person physical assist was provided more times than a two+ person physical assist.  Petitioner reinforces that there were times when “only one person support was needed, however, the highest level of support would be documented on the MDS.”  P. Br. at 8. 

Petitioner’s arguments concerning the March 2021 MDS do not aid Petitioner in this case.  As stated above, Petitioner was obligated 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); see 42 C.F.R. § 483.25.  The care plan must be periodically reviewed and revised by an SNF’s interdisciplinary team following MDS assessments.  42 U.S.C. § 1395i-3(b)(2)(C), (b)(3); see 42 C.F.R. § 483.20(d).  In the present case, although the March 2021 MDS indicated that Petitioner’s staff was providing one-person assists to R1 for bed mobility slightly more often than two-person assists, and Petitioner’s staff was only providing one-person assists for changing R1, Petitioner did not change R1’s care plan to reflect the MDS assessment.  Therefore, the requirements in the care plan for a two-person assist for bed mobility and “maximum assistance” with ADLs remained in effect in May 2021. 

Similarly, the March 23, 2021 Restorative Assessment of R1 made by the restorative nurse does not assist Petitioner’s case.  The assessment indicated that an “Extensive Assist” was needed to roll R1 from supine to right or left side and back to supine position and “Total Assist” moving R1 to and from supine to sitting and moving R1 up and down in bed.  CMS Ex. 6 at 1.  The assessment also indicated that R1 required the use of a Hoyer lift, was unable to ambulate, and required an “Extensive assist” for upper body dressing but a “Total assist” for lower body dressing.  CMS Ex. 6 at 2-3.  The assessment noted that R1’s range of motion was impaired on one side and that R1 had rigid or spastic muscle tone.  CMS Ex. 6 at 5.  Finally, the restorative nurse made a progress note stating that the range of motion of R1’s legs is severely limited and that R1 receives physical assistance with bed mobility and should “continue receiving extensive to total assist with bed mobility, transfer, locomotion, dressing, hygiene, toileting, and bathing.”  CMS Ex. 6 at 6-7.  Even if this assessment could assist Petitioner’s argument, this assessment did not result in a change to the requirements in the care plan. 

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Based on the evidence of record, I conclude that Petitioner failed to provide services to R1 in accordance with the care plan when only one staff member was moving R1 in bed/changing R1 in bed.  42 C.F.R. § 483.25; Azalea Ct., DAB No. 2352 at 12 (2010) (2010) aff’d, Azalea Ct. v. United States Dep’t of Health & Human Servs., 482 F. App’x 460 (11th Cir. 2012) (“[A] facility's care plan indicates the facility’s assessment of what the resident needs, and that failure to follow the care plan may be grounds for concluding that the facility is not in substantial compliance with section 483.25 quality of care standards.”).

The next question is whether such a failure caused R1 to be at risk for more than minimal harm.  Given R1’s fragile physical condition, I conclude that it did. 

As stated earlier in this decision, I found that the record provides a chronology of events that is sufficient to show that V11’s actions in changing R1 without assistance resulted (or could have resulted) in injury to R1.  The statement of the orthopedic surgeon (V13) who treated R1 at the hospital is clear in this regard.  The orthopedic surgeon said: 

[R1] did have an impacted distal fracture on the left femur.  It was right above the knee.  Impacted means the 2 bones where the knee meets we[re] pushed together.  This usually happens from a direct fall or high impact injury.  I don’t know if we ever got an answer on what happened to [R1] to cause this.  If [R1] didn’t fall, this could have happened in the bed as well.  It can happen for a lot of reasons.  Based on the x-ray, [R1’s] bones have severe osteopenia if not osteoporosis which makes fractures a lot more likely as well.  If [R1] wasn’t being turned properly in bed this could have happened.  If [R1’s] body was going one way, and [R1’s] leg was going a different way this is what could’ve caused this.  With someone with [R1’s] age and condition of [R1’s] bones, they would definitely need to always follow their protocols on properly turning residents and taking extra care and precaution with them because they can fracture so easily.  This fracture would not indicate abuse.  That would be a spiral fracture and this was not that.  [R1’s] bones were extremely fragile and taking extra precautions while turning or providing care could have prevented this from happening.  [R1] would have been in pain immediately after this occurred and then probably anytime she moved [R1’s] leg after that. 

CMS Ex. 11 at 9 (emphasis added); see also CMS Ex. 10 ¶ 13.  The orthopedic surgeon’s statements do not conclusively prove how R1 was injured. However, the statements

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make it clear that simply turning part of R1’s body in one direction without turning the other part of the body in the same direction at the same time could have led to the fracture in this case.  R1’s bones were so fragile that R1 was vulnerable to injury based on failing to follow proper protocols, such as the care plan. 

The state agency surveyor, who holds a nursing degree and is an experienced registered nurse (CMS Ex. 10 at 1, 5), testified how a two-person assist could help avoid the danger described by the orthopedic surgeon: 

Based on my knowledge and experience, I understand that “changing” means changing a patient’s bedding or clothing and, when two people assist, one person helps stabilize the patient’s body (for example, to keep them from twisting or falling) and the other person will change out the bedding or clothing. 

CMS Ex. 10 ¶ 9 (emphasis added).  It is easy to see, from this description, that a two-person assist would greatly enhance R1’s safety while being changed.  Conversely, a single-person assist would threaten R1’s safety.  See CMS Ex. 11 at 8 (V11 describing how V11 would use one hand to press on R1 to hold R1 in place and use the other hand to change R1’s clothing). 

Consistent with this, Petitioner’s DON told the state surveyor that the DON thought R1 was injured during the changing of R1’s clothes.  The DON stated:  

[R1] never said she fell and hit the floor.  She kept motioning like over over as if it happened when she was being turned. She couldn't really tell us more than that.  I remember going up to her room the morning [May 14, 2021] they told me she had a fracture.  I looked at her legs and they were straight and they had no signs of swelling or bruising.  So it’s likely she got this fracture while being turned in bed and her having osteopenia causes everything to be weaker.  We are still doing our investigation to try to figure out when this happened.  I know Staff do assist her with changing.  She really only need[ed] one person to assist because she can help a little bit. 

CMS Ex. 11 at 4 (emphasis added); see CMS Ex. 10 ¶ 10.  Petitioner neither submitted a final report of the DON’s investigation into the cause of R1’s fracture nor written direct testimony from the DON as to the cause.  Therefore, I conclude that the DON’s conclusion above, that R1 most likely received the fracture while being turned in bed due

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to osteopenia, stands as the DON’s final conclusion.  This conclusion is consistent with the orthopedic surgeon’s statement and the record as a whole. 

A facility has the flexibility to choose the methods and devices it uses to prevent accidents, but the chosen interventions must provide an “adequate” level of supervision and assistance devices under the circumstances.  Heritage Plaza Nursing Ctr., DAB No. 2829 at 14 (2017) (citing Woodstock Care Ctr., DAB No. 1726 at 28-35 (2000) (“What is “adequate” depends in each case on the resident’s condition, the facility environment and the viable and preferred methods available to the facility.”)).  R1 is an obese, non-ambulatory, bedbound resident with left side hemiplegia, a generalized muscle weakness, osteopenia and severe osteoarthritis.  CMS Ex. 6 at 1.  R1 required 1/4 bilateral bed rails as assistive devices and a Hoyer lift for any and all transfers.  CMS Ex. 6 at 1-2.  On September 8, 2018, R1 was assessed as requiring “two person assist[s] with bed mobility.”  CMS Ex. 7 at 1.  On December 29, 2020, a second nurse assessed R1 as requiring “maximum assistance for “range of motion, bed mobility, transfer, wheelchair mobility.”  CMS Ex. 7 at 5.  There are no further notes in any of R1’s records suggesting that R1 no longer required a two-person assist for these activities.  Due to R1 being unable to move R1’s legs and having left side hemiplegia, R1 required total assistance when changing R1’s lower half, and extensive assistance when changing R1’s upper half. 

As V11 was attempting to change R1 in bed on May 13, a two-person assist should have been utilized.  V11 admitted to relying on R1 to assist by holding bedrails, so that V11 could perform the one-person assist with one hand.  CMS Ex. 11 at 8.  These were decisions made at the discretion of the CNA, and contrary to the directives stated in R1’s care plan.  Moreover, the DON had knowledge that R1 was becoming physically weaker due to osteopenia, and even suspected that it, and R1 being turned in bed, were likely causes for R1’s fracture.  The DON’s statement to the surveyor that “[R1] really only need[ed] one person to assist because she can help a little bit,” is in contradiction to the directives established in R1’s care plan and assessments, and further shows Petitioner did not ensure that staff followed that plan. 

As the state surveyor summed up the situation in testimony: 

Based on my knowledge and experience, V11’s admission that she would change R1 by herself violates the standard of care.  Based on my knowledge and experience, the applicable standard of care would have always required a two-person assist when that is what a patient’s plan of care requires.  Further, V11’s admission that R1 experienced pain after being changed by only one person supports the finding of actual harm to R1 when only one individual provided bed mobility for R1, contrary to R1’s care plan. 

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CMS Ex. 10 ¶ 12.  I give weight to this testimony.  Although R1’s records show that R1 had multiple limiting physical circumstances, the records do not show that R1 had any

existing physical injuries before being fractured.  CMS Exs. 6-9.  And the record points to the one-person assist when changing R1 on May 13, 2021, as the likely event that caused the fracture.  Petitioner has submitted not evidence to contradict that.  

In performing a one-person assist while changing R1 in bed, Petitioner failed to take all reasonable steps to ensure that R1 received the proper weight-bearing support from a two-person assist, in order to prevent a foreseeable accident.  Briarwood, DAB No. 2115 at 11.  The use of a one-person assist, instead of a two-person assist, for a resident that was obese, non-ambulatory, with osteopenia and severe osteoarthritis, and had left sided hemiplegia, caused the pain to R1’s left leg on May 13, which is evidence of the harm R1 received.  Therefore, Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(d). 

4. The $11,715 per-instance CMP that CMS imposed is appropriate under applicable statutory and regulatory factors. 

CMS imposed a single per-instance CMP in the amount of $11,715 on Petitioner.  CMS Ex. 2 at 2.   When determining whether a CMP amount is appropriate, I apply the factors listed in 42 C.F.R. § 488.438(f):  1) the facility’s history of noncompliance; 2) the facility’s financial condition; 3) the factors specified in 42 C.F.R. § 488.404; and 4) the facility’s degree of culpability, which includes neglect, indifference, or disregard for resident care, comfort, or safety.  See 42 U.S.C. §§ 1320a-7a(d)(2), 1395i-3(h)(2)(B)(ii)(I).  The absence of culpability is not a mitigating factor.  42 C.F.R. § 488.438(f).  The factors listed in 42 C.F.R. § 488.404 include:  1) the scope and severity of the deficiency; 2) the relationship of the deficiency to other deficiencies resulting in noncompliance; and 3) the facility’s prior history of noncompliance in general and specifically with reference to the cited deficiencies.  See 42 U.S.C. §§ 1320a-7a(d)(1), (3), 1395i-3(h)(2)(B)(ii)(I). 

The regulations leave the decision regarding the choice of remedy to CMS, and the amount of the remedy to CMS and the ALJ, requiring only that the regulatory factors at §§ 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 makes no argument to the imposition of the per-instance CMP other than to state that it is “unreasonable because there is no non-compliance found in these facts.”  P. Br. at 12.  Petitioner does not argue that any specific regulatory

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factor supports a reduction or elimination of the CMP as unreasonable.  Despite this, I discuss the factors below for completeness. 

CMS asserts that its penalty amount is reasonable based on Petitioner’s noncompliance.  CMS notes that the $11,715 amount is far less than the maximum permissible per-instance penalty amount of nearly $21,663.  CMS also argues that Petitioner has a history of deficiencies and that this case involves actual harm to a resident.  CMS Br. at 11. 

As discussed above, I have determined that Petitioner was noncompliant with 42 C.F.R. § 483.25(d)(Tag F-689) with respect to R1.  CMS had a basis for imposing the CMP as a remedy for the noncompliance.  Petitioner’s general argument to the contrary is without merit. 

Facility’s History of Non-Compliance:  CMS argues that Petitioner’s history of noncompliance supports the CMP imposed.  CMS Br. at 11.  Petitioner failed to be in substantial compliance with program requirements for surveys conducted every year since 2018.  Petitioner had 11 “D” level deficiencies, one of which involved the same deficiency as in this case, Tag F-689, in 2018.  In 2019, Petitioner had three “F” level deficiencies, seven “E” level deficiencies, and six “D” level deficiencies.  In 2020, Petitioner had 1 “E” level deficiency and 1 “D” level deficiency.  CMS did not, however, impose remedies for any of these deficiencies in 2018, 2019 and 2020.  CMS Ex. 13 at 3-6.  Although Petitioner’s past history did not involve the imposition of sanctions, I also acknowledge that there are many deficiencies.  Therefore, this factor provides some support for the CMP amount that CMS imposed. 

Scope and Severity of Deficiencies and Relationship Between Deficiencies:  CMS argues that the seriousness of the offense (G level- actual harm) supports the CMP.  CMS Br. at 11.  As indicated above, while the question of actual harm was not a matter that could be reviewed in this case, I concluded above that the record supports a finding that the deficiency resulted in harm to R1.  This provides strong support for the CMP amount imposed. 

Culpability:  I conclude that Petitioner is quite culpable in this case.  Petitioner assessed R1 as a non-ambulatory, obese, bedbound individual, needing the assistance of a Hoyer lift for all transfers, severely limited in both the upper and lower extremities, and having osteoarthritis.  CMS Ex. 9 at 2; CMS Ex. 6 at 1; CMS Ex. 4 at 1.  While R1 had no previous falls, R1 was assessed as being “at risk for falling” as early as 2015.  CMS Ex. 9 at 15.  As of September 2018, R1 was assessed as needing a “two-person assist with bed mobility.”  In 2020, R1 required “supervision and set up for ADLs related to left sided hemiplegia,” and required “maximum assistance during [ADLs] (i.e.; range of motion, bed mobility, transfers, wheelchair mobility).”  CMS Ex. 9 at 18.  R1’s care plan never noted a change in the requirement for a two-person assist for bed mobility.  Yet, in spite of this, Petitioner’s staff routinely performed one-person assists for R1 and constantly

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relied on R1 to assist in daily ADLs.  See P. Ex. 4.  The staff had knowledge that R1’s bones were getting weaker due to osteoarthritis and other specified disorders of bone density and structure.  CMS Ex. 9 at 2; CMS Ex. 6 at 1; CMS Ex. 4 at 1.  However, some staff ignored the directives in R1’s care plan and instead used their own judgment on a daily basis to determine whether R1 needed a one or two-person assist with ADLs, including dressing.  The CNA responsible for changing R1 on the afternoon of May 13 (V11) even stated that “[t]here isn’t anything we really go off of we just kind of change the residents by knowing them and what they can do.”  CMS Ex. 11 at 8.  Due to the staff’s disregard of the assistance required by R1’s care plan, R1 was placed in pain likely due to a fracture of her femur.  I find that Petitioner’s culpability provides significant support for the CMP amount CMS imposed. 

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 $11,715 is in the middle of the penalty range.  Such a penalty is appropriate based on the factors considered above. 

VII.  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 $11,715 per‑instance CMP is appropriate under statutory and regulatory factors.

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Endnotes

¹   It is the duty and responsibility of the Secretary to assure that requirements which govern the provision of care in skilled nursing facilities . . . are adequate to protect the health, safety, welfare, and rights of residents and to promote the effective and efficient use of public monies.”  42 U.S.C. § 1395i-3(f)(1). 

²   All citations to the Code of Federal Regulations are to the version in effect at the time of the survey unless otherwise indicated. 

³  Petitioner’s counsel, Eva Byerly, who often represents SNFs in the Generations Healthcare Network in proceedings before CRD ALJs, used vague language as to whether counsel is seeking to cross-examine CMS’s witness(es).  The SPO in this case, just like the orders issued by several other CRD ALJs, requires an explicit request from a party to cross-examine a witness.  SPO ¶ 11.  Another CRD ALJ recently noted counsel’s familiarity with this requirement from past cases and interpreted Petitioner’s vague request concerning cross-examination as an effort to evade the valid purpose of these orders.  Generations at Rock Island, DAB CR6200 at 11-12 (2022) (“Parties are simply not free to rewrite judge’s orders.”).  As in this case, I previously had CRD staff email counsel to clarify the ambiguous allusion to cross-examination in counsel’s filing and, just as in this case, Petitioner’s counsel did not respond.  Generations at Peoria, DAB CR5819 at 6 (2021).  Counsel is placed on notice that future use of vague or ambiguous language concerning a request to cross-examine witnesses will result in waiver of the right to cross-examine those witnesses.  See 42 U.S.C. § 1320a-7a(c)(4) (made applicable to this proceeding by 42 U.S.C. § 1395i-3(h)(2)(B)(ii)(I)) (making sanctionable a failure to comply with an order or procedure).  

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   In this case, the parties appear to sometimes discuss bed mobility as a separate action from changing R1’s clothing.  The record in this case supports the conclusion that, given R1’s level of immobility, changing clothes, especially the lower extremities, necessarily included moving R1 in bed.  Petitioner’s restorative nurse described how one person would change R1’s clothing:  “When one staff changes [R1] they use the sheet to help move her around so two people aren’t needed.”  CMS Ex. 11 at 6.  Therefore, because the care plan is silent as to specifically how many individuals should change R1’s clothing, I am persuaded that the two-person requirement for bed mobility would apply because staff moved R1 in bed when changing R1.