Willow Rehab & Nursing, DAB CR6471 (2024)

DECISION

Petitioner, Willow Rehab & Nursing, is a skilled nursing facility, located in Kilgore, Texas, that participates in the Medicare program.  One of its residents, a 91-year-old woman with a history of falls, fell twice within a few hours.  Her second fall resulted in fractures and head injuries.  She was hospitalized, and, after refusing some recommended treatments, she died.

Following a complaint investigation, completed on August 30, 2022, the Centers for Medicare & Medicaid Services (CMS) determined that the facility was not in substantial compliance with Medicare program requirements and imposed civil money penalties (CMPs) of $23,989 per day for one day of immediate jeopardy and $245 per day for 16 days of substantial noncompliance that did not pose immediate jeopardy.  Petitioner appealed.  The parties agree that this matter should be resolved on summary judgment.

For the reasons set forth below, I find that, from August 29 through September 14, 2022, the facility was not in substantial compliance with Medicare program requirements; that, on August 29, its deficiencies posed immediate jeopardy to resident health and safety; and that the penalties imposed are reasonable.

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Background

The Social Security Act (Act) sets forth requirements for nursing facilities to participate in the Medicare program and authorizes the Secretary of Health and Human Services to promulgate regulations implementing those statutory provisions.  Act § 1819.  The Secretary's regulations are found at 42 C.F.R. Part 483.  To participate in the Medicare program, a nursing facility must maintain substantial compliance with program requirements.  To be in substantial compliance, a facility's deficiencies may pose no greater risk to resident health and safety than "the potential for causing minimal harm."  42 C.F.R. § 488.301.

The Secretary contracts with state survey agencies to conduct periodic surveys to determine whether skilled nursing facilities are in substantial compliance.  Act § 1864(a); 42 C.F.R. § 488.20.  Each facility must be surveyed annually, with no more than fifteen months elapsing between surveys.  Facilities must be surveyed more often, if necessary, to ensure that identified deficiencies are corrected.  Act § 1819(g)(2)(A); 42 C.F.R. §§ 488.20(a); 488.308.  The state agency must also investigate all complaints.  Act § 1819(g)(4).

Here, on August 30, 2022, a surveyor from the Texas Department of Health and Human Services (state agency) completed a complaint investigation survey of the facility.  Based on his findings, CMS determined that the facility was not in substantial compliance with the following Medicare participation requirements:

• 42 C.F.R. § 483.10(g)(14)(i)-(iv)(15) (Tag F580 – resident rights:  notification of changes), cited at scope and severity level D (isolated instance of substantial noncompliance that causes no actual harm with the potential for more than minimal harm);
• 42 C.F.R. § 483.12(a)(1) (Tag F600 – freedom from abuse, neglect, and exploitation), cited at scope-and-severity level J (isolated instance of substantial noncompliance that poses immediate jeopardy to resident health and safety);
• 42 C.F.R. § 483.12(c)(1)(4) (Tag F609 – freedom from abuse, neglect, and exploitation:  reporting alleged violations), cited at scope-and-severity level D;
• 42 C.F.R. § 483.25(d)(1) and (2) (Tag F689 – quality of care:  accident prevention), cited at scope-and-severity level G (isolated instance of substantial noncompliance that causes actual harm but does not pose immediate jeopardy to resident health and safety); and

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• 42 C.F.R. §§ 483.20(f)(5), 483.70(i)(1)-(5) (Tag F842 – resident assessment:  records – identifiable information and administration:  medical records), cited at scope and severity level D.

CMS Exs. 1, 2.

CMS imposed per-day CMPs of $23,989 per day for one day of immediate jeopardy (August 29, 2022) and $245 per day for 16 days of substantial noncompliance that did not pose immediate jeopardy (August 30 through September 14, 2022) (Total:  $23,989 + $3,920 = $27,909).  CMS Ex. 1 at 1.

Rule 56(f) order.  The parties submitted pre-hearing briefs (CMS Br.; P. Br.).  With its brief, CMS submitted eight exhibits (CMS Exs. 1-8).  Petitioner submitted no exhibits.

Based on my initial review of the parties' submissions, it appeared that no material facts are in dispute, and that summary judgment might be appropriate.  Pursuant to Rule 56(f) of the Federal Rules of Civil Procedure, I issued an order, dated November 3, 2023, identifying what appear to be material facts not in dispute and giving the parties notice and the opportunity to respond.  Rule 56(f) Order (e-file # 16).¹

In response, the parties did not dispute any of the facts listed in my order and agreed that this matter would be decided on summary judgment.

Exhibits.  Petitioner has objected to my admitting CMS Exs. 2, 4, 6, and 8.

For purposes of summary judgment, I need not rule on whether these documents are admissible.  Rather, I must consider all proffered evidence to determine whether it creates a material fact in dispute.  Lilia Gorovits, M.D., P.C., DAB No. 2985 at 3 n.4 (2020), aff'd, Gorovits v. Becerra, 20-1850 (E.D. Pa. May 17, 2021); Ill. Knights Templar Home, DAB No. 2274 at 6-7 (2009).

In any event, Petitioner's objections are without merit.  The documents would be admissible.

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The Federal Rules of Evidence do not apply in these proceedings, and I may receive evidence, including hearsay, that would be inadmissible under the federal rules.  42 C.F.R. § 498.61; Lifehouse of Riverside Healthcare Ctr., DAB No. 2774 at 9 (2017).

I have broad discretion to admit evidence and may admit hearsay "consistent with procedural integrity and fundamental fairness."  Omni Manor Nursing Home, DAB No. 1920 (2004); Britthaven Inc. d/b/a/ Britthaven of Smithfield, DAB No. 218 at 3 (2006) ("In administrative proceedings generally, and in Chapter 498 proceedings expressly, hearsay is admissible and can be probative on the issue of the truth of the matter asserted, where sufficient indicia of reliability are present.").

Indeed, I am required to "inquire[] fully into all of the matters at issue" and to admit "any documents that are relevant and material."  42 C.F.R. § 498.60(b) (emphasis added).

CMS Ex. 2 is the Statement of Deficiencies.  Petitioner objects to its admission, arguing that it contains "inadmissible hearsay."

A statement of deficiencies sets out the survey findings on which CMS based its enforcement actions that are the subject of appeal and, for that reason, is "unquestionably relevant and material evidence."  Avalon Place Trinity, DAB No. 2819 at 38 (2017) (emphasis added).  See Oxford Manor, DAB No. 2167 at 2 (2008) (holding that a statement of deficiencies may function both as a notice document and as evidence of facts asserted therein); Jennifer Matthews Nursing & Rehab., DAB No. 2192 at 4 n.2 (2008) (holding that CMS need not present evidence in support of a finding that is not disputed); Guardian Health Care Ctr., DAB No. 1943 at 12 (2004) (characterizing the statement of deficiencies as a "contemporaneous record of the survey agency's observations and investigative findings.").  Because the document is relevant and material, it must be admitted.

Petitioner also claims that a provision of the Medicare State Operations Manual, "SOM 107, Ex. 7A," mandates that surveyors "exclude any and all information from a deficiency statement that could demonstrate Petitioner's compliance with the specific requirement at issue."  P. Objections at 1.  Petitioner's claim is puzzling.  Clicking on the cited link brings up Appendix PP of the State Operations Manual, which is a massive document (863 pages).  If Appendix PP instructs surveyors to exclude relevant information, it is not readily apparent, and Petitioner does not specify where such language is found.  See Standing Order at 3 (¶ 4c(1)) (requiring the party to cite page numbers).  In any event, even if Petitioner's allegation were true, Petitioner was free to submit any relevant information that demonstrates the facility's compliance with a specific requirement.

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On the other hand, Petitioner may be complaining that the survey report form lists deficiencies and does not ask for instances in which surveyors find no deficiencies.  As set forth in the statute and regulations, surveys necessarily must identify deficiencies.  See Act § 1819(g); 42 C.F.R. § 488.318(c) (directing surveyors to identify valid deficiencies).

CMS Ex. 4 pp. 28-36.  CMS Ex. 4 generally consists of a resident's medical records.  See Rule 56(f) Order at 3.  However, included within the document are photographs of a seriously injured individual.²  According to Petitioner, facility staff did not take the photographs, and they are not maintained in the resident's medical records.  In deciding whether these photographs are admissible, the question is whether they are relevant and material.  42 C.F.R. § 498.60(b).  The pictures include a shot of the resident's ID bracelet, which identifies her as R1, and the injuries shown are consistent with those described in that resident's medical records (discussed below).  CMS Ex. 4 at 31.  I agree that the note included as part of CMS Ex. 4 at 33 is inaccurate, as shown by the evidence discussed below.  I will therefore afford the statement no weight.  With respect to the remaining pictures, Petitioner was free to present evidence – such as a statement from a staff member – challenging the identity of the resident pictured, which it did not do.  The photographs, although not dispositive, are relevant and material and therefore admissible.

CMS Exs. 6 and 8.  Petitioner conflates CMS Exs. 6 and 8.  CMS Ex. 8 is the surveyor's written declaration; the surveyor notes make up CMS Ex. 6.  Petitioner argues that both contain "inadmissible hearsay."  Again, hearsay is admissible in these proceedings.

Moreover, in my Rule 56(f) Order, I cited portions of the surveyor notes (CMS Ex. 6) and indicated that Petitioner produced no evidence suggesting a dispute over the contents.  Rule 56(f) Order at 4.  In agreeing to summary judgment, Petitioner did not challenge my observation and did not assert any dispute over that section of the exhibit.

The remaining notes include interviews with facility employees and the surveyor's contemporaneous observations and conclusions.  Even under the Federal Rules of Evidence, the employee statements would be admissible.  The facility could have questioned those employees and offered rebuttal, which it has chosen not to do.  Beatrice State Developmental Ctr., DAB No. 2311 at 17, 18 (2010) (pointing out that the facility could have but did not present employee testimony that refuted the statements the surveyors claimed they made); Omni Manor Nursing Home, DAB No. 1920 at 9-11 (holding that the facility employees' statements to the surveyors may be admitted and may constitute substantial evidence); see Fed. R. Evid. Rule 801(d) (making statements from an opposing party admissible; Rule 803(5) (making recorded recollections admissible).  In any event, the notes are relevant and material and thus admissible.

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The surveyor's written declaration (CMS Ex. 8) sets out the basics of the survey process (CMS Ex. 8 at 2 (¶¶ 4, 5), describes the contents of the facility's records CMS Ex. 8 at 2-3 (¶¶ 7, 8, 9), recounts interviews with facility employees CMS Ex. 8 at 3-4 (¶¶ 10, 11), and draws conclusions based on the survey findings (CMS Ex. 8 at 2 (¶ 6), 4 (¶¶ 12, 13).  The proffered testimony is relevant and material and thus would be admissible.

Issues

• From August 29 through September 14, 2022, was the facility in substantial compliance with Medicare program requirements?
• If, on August 29, 2022, the facility was not in substantial compliance with 42 C.F.R. § 483.12(a)(1) (Tag F600 – freedom from abuse, neglect, and exploitation), did that deficiency pose immediate jeopardy to resident health and safety.
• If the facility was not in substantial compliance, are the penalties imposed – $23,989 per day for one day of immediate jeopardy and $245 per day for 16 days of substantial noncompliance that did not pose immediate jeopardy – reasonable?

Discussion

Summary judgment.  Summary judgment is appropriate if a case presents no genuine issue of material fact, and the moving party is entitled to judgment as a matter of law.  Southpark Meadows Nursing & Rehab. Center, DAB No. 2703 at 5 (2016); W. Texas LTC Partners, Inc., DAB No. 652 at 5 (2015), aff'd, W. Tex. LTC Partners, Inc. v. U.S. Dep't of Health & Human Servs., 843 F.3d 1043 (5th Cir. 2016); Bartley Healthcare Nursing & Rehab., DAB No. 2539 at 3 (2013) (citing Celotex Corp. v. Catrett, 477 U.S. 317, 322-25 (1986)); Ill. Knights Templar Home, DAB No. 2274 at 3-4, and cases cited therein.³

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The moving party may show the absence of a genuine factual dispute by presenting evidence so one-sided that it must prevail as a matter of law or by showing that the non-moving party has presented no evidence "sufficient to establish the existence of an element essential to [that party's] case, and on which [that party] will bear the burden of proof at trial."  Livingston Care Ctr. v. U.S. Dep't of Health & Human Servs., 388 F.3d 168, 173 (6th Cir. 2004) (quoting Celotex, 477 U.S. at 322).  To avoid summary judgment, the non-moving party must then act affirmatively by tendering evidence of specific facts showing that a dispute exists.  Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 586 n.11 (1986); see also Vandalia Park, DAB No. 1939 (2004); Lebanon Nursing & Rehab. Ctr., DAB No. 1918 (2004).  The non-moving party may not simply rely on denials but must furnish admissible evidence of a dispute concerning a material fact.  Ill. Knights Templar, DAB No. 2274 at 4; Livingston Care Ctr., DAB No. 1871 at 5 (2003).  In doing so, the non-moving party must show more than "some metaphysical doubt as to the material facts."  W. Tex. LTC Partners, DAB No. 2652 at 6; 1866ICPayday.com, L.L.C., DAB No. 2289 at 3 (2009) (quoting Matsushita, 475 U.S. at 587).

In examining the evidence for purposes of determining whether summary judgment is appropriate, I must draw all reasonable inferences in the light most favorable to the non-moving party.  Brightview Care Ctr., DAB No. 2132 at 2, 9 (2007); Livingston Care Ctr., 388 F.3d at 172; Guardian Health Care Ctr., DAB No. 1943 at 8 (2004).  However, drawing factual inferences in the light most favorable to the non-moving party does not require that I accept the non-moving party's legal conclusions or draw inferences that are not reasonable.  W. Tex. LTC, DAB No. 2652 at 6-7; cf. Guardian, DAB No. 1943 at 11 ("A dispute over the conclusion to be drawn from applying relevant legal criteria to undisputed facts does not preclude summary judgment if the record is sufficiently developed and there is only one reasonable conclusion that can be drawn from those facts."); see Green Valley Health Care & Rehab. Ctr., DAB No. 2947 at 8 (2019), (quoting Johnson v. Perez, 823 F.3d, 701, 705 (D.C. Cir. 2016)) (noting that a genuine factual dispute does not exist "when a putatively disputed body of evidentiary material could not, even assuming a sympathetic factfinder, reasonably support a finding crucial to the nonmoving party's legal position."); Brightview, DAB No. 2132 at 10 (entry of summary judgment upheld where inferences and views of non-moving party are not reasonable).

Summary judgment applied to administrative review in Medicare cases.  It is well-established that an administrative law judge is empowered to decide a case on a motion for summary judgment, without an evidentiary hearing.  Shah v. Azar, 920 F.3d 987, 996 (5th Cir. 2019), citing Cedar Lake Nursing Home v. U.S. Dep't of Health & Human Servs., 619 F.3d 453, 457 (5th Cir. 2010); see Fal-Meridian, Inc. v. U.S. Dep't of Health & Human Servs., 604 F.3d 445, 449 (7th Cir. 2010).

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There seems to be some confusion about applying such well-founded principles of civil litigation to these proceedings, with some suggesting that, to do so, denies a party a fundamental right.  In one succinct observation, Judge Posner of the Seventh Circuit Court of Appeals shattered this misconception:  "All it means for a decision to be based on a grant of summary judgment is that there are no issues that would benefit from being resolved in an evidentiary hearing."  Fal-Meridian, 604 F.3d at 449 (emphasis added).

Summary judgment applied to CMPs.  Whether the penalty amount imposed is reasonable is a legal, not a factual issue. To overcome a summary judgment motion as to the reasonableness of the penalties, the facility must proffer evidence sufficient to create a genuine dispute about facts affecting how the regulatory factors should be assessed.  Vibra Hospital of Charleston, DAB No. 3094 at 30 (2023); Crawford Healthcare, DAB No. 2738 at 19 (2016).

1. The undisputed evidence establishes that the facility was not in substantial compliance with 42 C.F.R. §§ 483.12 and 483.25 because, after one of its vulnerable residents suffered multiple falls, facility staff did not provide her with the goods and services she needed to prevent accidents and remain safe.⁴

Resident 1 (R1).  R1 was a 91-year-old woman, initially admitted to the facility on October 16, 2021, and readmitted, following a hospitalization, on August 2, 2022.  She suffered from a long list of impairments, including heart failure, chronic obstructive pulmonary disease, emphysema, hypertension, atrial fibrillation, and dementia.  CMS Ex. 2 at 8; CMS Ex. 4 at 1-2, 4.  She required hands-on assistance to move from place to place.  CMS Ex. 4 at 38.  Her cognition was impaired.  CMS Ex. 4 at 54, 68, 87.  A quarterly assessment, dated July 26, 2022, showed that she had a BIMS (Brief Interview for Mental Status) score of five, which indicates severely impaired cognition.  CMS Ex. 2 at 8; CMS Ex. 4 at 201.

R1 required supervision and a one-person physical assist for bed mobility, transfer, walking in her room, dressing, and toilet use.  CMS Ex. 2 at 8-9.

She required oxygen.  CMS Ex. 4 at 86.

R1 scored 9 on a fall risk assessment, dated October 16, 2021, which put her at moderate risk for falls.  According to the assessment, she required "hands-on assistance to move from place to place."  CMS Ex. 4 at 37-38.  In a second unsigned and undated fall risk evaluation, nine risk factors are checked; however, the section assessing R1's mobility (gait/balance) is left blank, and her fall risk is not ultimately assessed.  Nevertheless, the

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document indicates that the resident had fallen two or more times and suffered an injury at least once.  CMS Ex. 4 at 23.

R1's care plan.  It is well-settled that a resident's care plan represents the facility's judgment about what care and services are needed to keep the resident safe.  If facility staff fail to provide care and services in accordance with the resident's comprehensive assessment and plan of care, it violates section 483.25.  White Sulphur Springs Ctr., DAB No. 2520 at 7 (2013); Deltona Health Care, DAB No. 2511 at 7-8 (2013); Venetian Gardens, DAB No. 2286 at 5 (2009).

R1's care plan, initiated on December 21, 2021, identifies her potential for falls "related to her dementia and disease process."  The plan lists three interventions:  1) anticipate and meet the resident's needs – place frequently-used items within easy reach; 2) encourage the resident to participate in activities that promote exercise, physical activity for strengthening, and improved mobility; and 3) review information on past falls to determine the cause.  Record possible root causes.  Alter or remove potential causes, if possible.  Educate resident, family, and caregivers.  CMS Ex. 4 at 61.

R1's falls and the facility's response (or lack of response).  At 5:35 p.m. on April 2, 2022, staff "noted" R1 sitting on the floor by the side of her bed with a piece of meat in her hand.  The resident told staff that she had been in the bathroom.  She did not complain of pain, and an assessment revealed no injuries.  Staff assisted her up, and, according to the resident's medical records, notified her physician, the assistant director of nursing (DON), and the resident's daughter.  Also, according to R1's medical records, staff began neuro-checks.  CMS Ex. 4 at 5, 100.⁵

An incident report, dated April 2, labels the incident "fall from bed," which appears to be a mistake because the report also says that the resident was ambulating without assistance.  She was assessed and "assisted up."  She suffered no injuries, according to the report.  Ambulating without assistance is checked as a "predisposing situation factor."  CMS Ex. 4 at 100-101.  According to the form, a family member was notified at 5:55 p.m.; the DON was notified at 6:00 p.m.; and the physician was notified at 5:45 p.m.  CMS Ex. 4 at 102.

Facility staff did not re-assess the resident for fall risks, and her care plan was not updated.  CMS Ex. 2 at 10; see CMS Ex. 4 at 52-87.

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A progress note, entered on July 11, 2022, at 6:27 p.m., indicates that R1 was found sitting on the bathroom floor with her pull-up on top of her pants.  She told staff that "she ha[d] been sitting there since [the] night before last."  She was assessed, assisted to the bathroom, redressed, and assisted to bed.  According to the records, her physician and her family member were notified, and neuro-checks were started.  She was uninjured and, notwithstanding the fall, thereafter, she continued to ambulate to the bathroom and elsewhere, unassisted.  CMS Ex. 4 at 3.

An incident report puts the time of the incident at 4:00 p.m. on July 11 and lists five predisposing physiological factors:  confused; weakness/fainted; gait imbalance; impaired memory; and recent illness.  "Ambulating without assistance" is again listed as a "predisposing situation factor."  As to her mental status, she was oriented to person only (not place, time, or situation).  The report describes no injuries.  According to the report, the resident's physician was notified at 4:10 p.m., and her family member was notified at 4:25 p.m.  A note directs staff to "provide non-slip socks for resident."  CMS Ex. 4 at 103-105 (emphasis added).

Again, the facility did not document a new fall assessment and did not update the resident's care plan.  No evidence suggests that staff gave R1 non-slip socks.  CMS Ex. 2 at 11; see CMS Ex. 4 at 52-87.

On July 29, 2022, at 11:10 p.m., a nurse aide found R1 sitting on the floor beside her bed.  The nurse aide notified "LVN A."  The resident was assessed, and no injuries were noted.  The resident's physician, family member, and the facility's DON were notified, according to the record.  CMS Ex. 4 at 10, 193.

An incident report prepared by LVN A reiterates this information and indicates that the resident was sitting on the floor with her right side against the bed.  No injuries were noted.  "Clutter," poor lighting, and furniture are identified as predisposing environmental factors.  "Confused," drowsy, weakness/fainted, gait imbalance, and impaired memory are again listed as predisposing physiological factors.  Ambulating without assistance and improper footwear are listed as predisposing situation factors.  According to the report, the family member, DON, and physician were all notified at 11:10 p.m.  CMS Ex. 4 at 106-108.

A few hours later, at 3:00 a.m. on July 30, 2022, R1 suffered another fall.  A nurse aide found her on the floor and helped her to the bedside.⁶  She had a large hematoma (bruise) on her forehead with slight bleeding.  A physician ordered her sent to the hospital.  Staff

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notified the DON.  CMS Ex. 4 at 9-10, 19; see CMS Ex. 4 at 32, 35, 36 (showing significant bruising on the resident's face).⁷

An incident report was prepared.  It confirms that R1 was found on the floor by a nurse aide and helped to her bedside.  She had a large hematoma on her forehead and slight abrasion.  She was sent to the emergency room.  Family, hospice, and the DON were notified.⁸  Again, the resident was oriented to person only.  Again, the predisposing environmental factors included clutter, crowding, poor lighting, and furniture.  Again, predisposing physiological factors were:  confused; drowsy; weakness/fainted; gait imbalance; and impaired memory.  Predisposing situation factors were ambulating without assistance and improper footwear.  CMS Ex. 4 at 109-110.

At the hospital, the resident was diagnosed with a contusion of the scalp, a closed nondisplaced fracture of the third cervical vertebra, and a compression fracture of the thoracic vertebra.  CMS Ex. 4 at 94, 113, 144.  Hospital physicians recommended that she wear a cervical collar.  They also noted that she had severe protein calorie malnutrition and a low potassium level (2.8).  She was discharged on August 2 and returned to the facility, bedbound and minimally responsive.  CMS Ex. 2 at 16-17; CMS Ex. 4 at 9, 24, 116, 189-190; see CMS Ex. 4 at 27, 29-36, 93.

Her family declined a physician-ordered feeding tube and some physician-recommended therapy.  Instead, R1 received palliative care with hospice services.

A fall risk assessment, completed on July 30, raised R1's fall risk score to 11, which the assessment form characterizes as a "moderate risk," although the facility's policy suggests that a score of ten or above is "high risk."  CMS Ex. 4 at 39; CMS Ex. 7 at 3.  The assessment incorrectly indicates that R1 had fallen only one to two times within the prior six months.  CMS Ex. 4 at 39.  In fact, as listed above, this was her fourth reported fall since April 2 (April 2, July 11, July 29, and July 30).  CMS Ex. 4 at 100-110.

An interdisciplinary post-fall assessment, following the July 30 fall, indicates that, at the time of the fall, R1 was ambulating independently, using a walker.  CMS Ex. 4 at 94.  According to an interdisciplinary screen, the resident had undergone recent changes in condition and a decline in transfer and mobility.  The family declined therapies and asked instead to continue R1's hospice services.  The assessment recommended an occupational

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therapy screen "to inservice staff on positions [and] bed mobility due to the [resident's] neck fracture."  CMS Ex. 4 at 96.

A progress note, entered at 12:14 p.m. on August 3, 2022, reiterates that R1 suffered a non-displaced fracture of the third cervical vertebra.  She was experiencing pain and discomfort.  CMS Ex. 4 at 8, 17.  She had also suffered a thoracic compression fracture related to the fall.  CMS Ex. 4 at 84.

Post-falls events.  We don't know when R1's family first complained that their mother had been abused, but on July 31, 2022, the facility reported the July 30 incident as an allegation of neglect.  The facility did not subsequently submit to the state agency a report of its investigation, despite repeated requests for it.  CMS Ex. 2 at 31-32.

At about 6:15 p.m. on August 3, one of R1's family members, obviously upset, questioned the night nurse about R1's fall, accusing him of assault.  The family also complained that the camera installed in the resident's room was not working and accused staff of sabotage.  CMS Ex. 4 at 8, 14-15.⁹

Police investigated the family's suspicions that a nurse had, in fact, assaulted R1.  The police did not find evidence of an assault.  However, the assigned detective reviewed video footage from the hallway outside R1's room.  Between 7:00 p.m. on July 29 until 4:00 a.m. on July 30, the nurse entered the resident room only twice:  at 11:04 p.m. on July 29 and at 2:55 a.m. on July 30.  CMS Ex. 2 at 24; CMS Ex. 6 at 22-23.  The nurse did not enter the resident's room at any other time.  In contrast, the facility records indicated that the same nurse had performed neuro-checks on R1 at 11:10 p.m., 11:25 p.m., 11:40 p.m., and 11:55 p.m. on July 29, and at 12:25 a.m., 12:55 a.m., 1:25 a.m., and 1:55 a.m. on July 30.  CMS Ex. 2 at 13-14; CMS Ex. 4 at 188.  Each assessment includes the date and time the nurse purportedly performed the check and indicates that:  the resident was alert; pupil responses were brisk; motor functions were normal; hand grasps were equal; all extremities were movable; pain response was appropriate; and vital signs were within normal limits.¹⁰  No seizures, headaches, vomiting, or paralysis were observed, according to the LVN's record entries.  CMS Ex. 2 at 15; CMS Ex. 4 at 188.

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The investigating officer also reported that a nurse aide "was very vocal about the LVN A not doing his job and neglecting [R1]."  CMS Ex. 2 at 24; CMS Ex. 6 at 22-23.  The surveyor spoke to that nurse aide.  The nurse aide explained that she had been in R1's room with LVN A at about 3:00 a.m. on July 30, which was after the resident's second fall of the night.¹¹  LVN A did not take the resident's blood pressure or assess her "at all," according to the nurse aide.  He waited for the emergency services.  CMS Ex. 2 at 25.

Petitioner did not present either LVN A or the nurse aide as witnesses.  The nurse aide has not denied making the statement.  Neither she nor anyone else has challenged its accuracy.  See Beatrice State Development Ctr., DAB No. 2311 at 17, 18 (pointing out that the facility could have but did not present employee testimony that refuted the statements the surveyors claimed they made); Omni Manor Nursing Home, DAB No. 1920 at 11 (holding that statements of facility employees to the surveyors may be admitted in an administrative proceeding and may constitute substantial evidence).

Effective August 2, R1's care plan was finally amended to add some additional interventions aimed at preventing falls.  In addition to anticipating the resident's needs, the plan calls for a floor mat, keeping the resident's bed in the lowest position when not providing care, and placing the resident's call light within reach.  Again, the plan calls for reviewing information on past falls to determine the cause.  Staff are again directed to record the possible root causes and, if possible, to alter or remove potential causes.  The plan directs them to educate the resident, the resident's family, and her caregivers.  CMS Ex. 4 at 79.

The plan also addresses R1's pain, related to her fall.  It recognizes that she is no longer able to communicate the presence of pain and depends on staff to monitor her by identifying the signs and symptoms of pain and providing appropriate interventions.  Staff are directed to monitor, record, and report signs and symptoms of nonverbal pain:  changes in breathing; vocalizations; changes in mood or behavior; eyes; and face.  The plan directs staff to administer pain medications and treatments according to physicians' orders.  They are required to monitor and document side effects of the pain medication, and, one hour after administration, to evaluate the effectiveness of the medication and other interventions.  Staff are supposed to record and report to the resident's physician any signs or symptoms of distress not relieved by the ordered medications and treatments.  CMS Ex. 4 at 85.

A note entered at 6:30 p.m. on August 4, 2022, indicates that the resident was transferred to an air mattress provided by hospice, and floor mats were in place at the sides of her

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bed.  Her legs were elevated.  She had dark purple bruises on her forehead, around both eyes, and on her right forearm.  CMS Ex. 4 at 13; see CMS Ex. 4 at 32, 35, 36.

An MDS (minimum data set) note, entered at 1:41 p.m. on August 5, 2022, reports an interdisciplinary team discussion regarding R1's "recent decline" in activities of daily living related to her recent falls with fractures to her cervical spine and thoracic spine.  The team determined that a "significant change in MDS" was required.  CMS Ex. 4 at 12.

At 9:23 p.m., progress notes describe a "rattle" or "congestion" in R1's upper chest.  A note entered at 4:31 a.m. the following morning, August 6, describes a significant decline in the resident's respiratory status.  Staff notified hospice and attempted to notify the family, but, according to the note, no one answered the call.  CMS Ex. 4 at 11-12.

At 12:25 a.m. on August 7, 2022, the nurse observed that R1 was not breathing.  She had no heart sounds.  The nurse notified hospice and the resident's daughter.  CMS Ex. 4 at 11.

Program requirement:  42 C.F.R. § 483.12 (Tags F600, F609).  The Act requires that facility residents be free from "physical or mental abuse, corporal punishment, [and] involuntary seclusion."  Act § 1819(c)(1)(A)(ii).  Consistent with that provision, the regulation governing abuse and neglect provides that a facility resident has the right to be free from abuse, neglect, and exploitation.  42 C.F.R. § 483.12.

"Abuse" is defined as the willful infliction of injury, unreasonable confinement, intimidation, or punishment, with resulting physical harm, pain, or mental anguish.  It includes depriving an individual of goods or services needed to attain or maintain physical, mental, and psychosocial wellbeing.  42 C.F.R. §§ 483.5, 488.301.

"Neglect" is defined as the failure of the facility, its employees, or service providers to provide a resident with the goods and services necessary to avoid the resident's suffering physical harm, pain, mental anguish, or emotional distress.  42 C.F.R. §§ 483.5, 488.301.

Among other requirements, the facility must develop and implement written policies and procedures that prohibit and prevent abuse, neglect, and exploitation of residents.  It must establish policies and procedures to investigate any such allegations; and it must train staff on activities that constitute abuse and neglect, procedures for reporting incidents of abuse and neglect, dementia management, and resident abuse prevention.  42 C.F.R. § 483.12(b)(1)-(3); see 42 C.F.R. § 483.95(c).

The facility must also ensure that all alleged violations involving abuse or resulting in serious bodily injury are reported immediately, but not later than two hours after the allegation is made, to the facility administrator and to appropriate state officials.  If the events did not involve abuse or result in serious bodily injury, the alleged violations must

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be reported to the administrator and state officials not later than 24 hours after the allegation is made.  42 C.F.R. § 483.12(c)(1).

The facility must have evidence that all alleged violations are thoroughly investigated.  42 C.F.R. § 483.12(c)(2).  Within five working days of the incident, the facility must provide reports of all investigations to the facility administrator and to the state agency.  42 C.F.R. § 483.12(c)(4).

Program requirement:  42 C.F.R. § 483.25(d) (Tag F689).  The Medicare statute mandates that the facility ensure that each resident receive, and the facility provide, the necessary care and services to allow the resident to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the resident's comprehensive assessment and plan of care.  Act § 1819(b)(2).

The quality-of-care regulation characterizes quality of care as a "fundamental principle that applies to all treatment and care provided to facility residents."  Based on the resident's comprehensive assessment, the facility must ensure that the resident receives treatment and care in accordance with professional standards of practice, the resident's comprehensive, person-centered care plan, and the resident's choices.  42 C.F.R. § 483.25.  To this end, the "quality-of-care" regulation mandates, among other requirements, that each resident's environment remain as free of accident hazards as possible and that each resident receive adequate supervision and assistance devices to prevent accidents.  42 C.F.R. § 483.25(d).  Del Rosa Villa, DAB No. 2458 at 7 (2012); Clermont Nursing & Convalescent Ctr., DAB No. 1923 at 9-10, aff'd sub nom. Clermont Nursing & Convalescent Ctr. v. Leavitt, 142 Fr. App'x. 900 (6th Cir. 2005); accord, Briarwood Nursing Ctr., DAB No. 2115 at 5 (2007) (holding that the facility must "take all reasonable steps to ensure that a resident receives supervision and assistance devices designed to meet his or her assessed needs and mitigate foreseeable risks of harm from accidents.").

The regulation "imposes on facilities an affirmative duty designed to achieve favorable outcomes to the highest practicable degree."  Sheridan Health Care Ctr., DAB No. 2178 at 14 (2008), citing Windsor Health Care Ctr., DAB No. 1902 at 16-17 (2003); Woodstock Care Ctr., DAB No. 1726 at 3-4 (2000), aff'd, Woodstock Care Ctr. v. Thompson, 363 F.3d 583 (6th Cir. 2003).  "The regulation focuses not on whether an accident occurs, but, rather, on whether the facility has provided supervision and assistance devices adequate to prevent an accident."  Kenton Healthcare, DAB No. 2186 at 13 (2008).

Facility Policies.  A facility's failure to follow its anti-neglect policy can put it out of substantial compliance with the anti-neglect regulation, as can its failure to follow other policies and procedures where those policies define what a facility deems "the goods and

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services necessary to avoid physical harm."  Avalon Place Kirbyville, DAB No. 2569 at 9 (2014).

Similarly, CMS "may reasonably rely on a facility's policy relating to the care and treatment of its residents as evidencing the facility's understanding of what must be done to attain or maintain its residents' highest practicable physical, mental, and psychosocial well-being, as required by section 483.25."  Green Valley Healthcare and Rehab. Ctr., DAB No. 2947 at 6, citing The Laurels at Forest Glen, DAB No. 2182 at 18 (2008); North Las Vegas Care Ctr., DAB No. 2946 at 6 (2019); Hanover Hills Health Care Ctr., DAB No. 2507 at 6 (2013) (observing that "the Board has long held that a facility's own policy may be sufficient evidence . . . of what the facility has determined is needed to meet the quality-of-care requirements in section 483.25.").

A facility violates [what is now] section 483.25(d) if it fails, without justifiable reason, to implement the accident precautions its own staff have determined are necessary to mitigate foreseeable accident risks.  Good Shepherd Home for the Aged d/b/a The Good Shepherd Home, DAB No. 2858 at 14 (2018), citing Del Rosa Villa, DAB No. 2458 at 9, aff'd Del Rosa Villa v. Sebelius, 546 F. App'x. 666 (9^th Cir. 2013); NHC Healthcare, Athens, DAB No. 2258 at 13 (2009); Burton Healthcare Ctr., DAB No. 2051 at 9 (2006).

Facility policy:  prohibiting abuse.  The facility's policy prohibiting abuse echoes the regulation:  "Residents have the right to be free from abuse, corporal punishment, and involuntary seclusion."  The policy emphasizes that all alleged violations must be reported immediately to the administrator or designee.  Staff must also notify local law enforcement, the state survey agency, the Department of Family and Protective Services (if appropriate), in accordance with federal and state law.  CMS Ex. 7 at 10.

The policy lists procedures designed to prevent abuse.  Those procedures include screening potential employees and training employees in prevention, interventions, detection, reporting, and employee rights.  CMS Ex. 7 at 11.

The policy lists other procedures for preventing abuse:

• Provide residents, families, staff, volunteers, and consultants with information on how and to whom to report – without fear of retribution – their concerns, incidents, and grievances.
• The facility administrator or designee provides feedback regarding the concerns expressed.
• A committee, selected and chaired by the administrator or designee, functions under the QAA (Quality Assessment and Assurance) Committee.  The committee meets, as needed, to identify, correct, and intervene in situations in which abuse,

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neglect, or misappropriation of resident property is more likely to occur.  This includes analyzing features of the physical environment that make abuse or neglect more likely (e.g., secluded areas); deploying staff in sufficient numbers to meet resident needs and to assure that assigned staff know the individual resident care needs; supervising staff to identify inappropriate behaviors; and assessing, care-planning, and monitoring residents with needs and behaviors that might lead to conflict or neglect.

Id.

The policy directs the facility's interdisciplinary team, in conjunction with the facility's administrative team, to:  identify residents at risk for abusing others; develop intervention strategies to prevent occurrences; monitor residents for changes that would trigger abusive behavior; and re-assess interventions at least quarterly during care-planning conferences and as needed, based on the individual's response to interventions.  CMS Ex. 7 at 12.

The policy lists ways the facility should identify events and occurrences that might contribute to abuse or neglect:  educate and encourage participants to report concerns, incidents, and grievances through the Resident Council, the care plan conferences, family conferences, or staff meetings; review incident reports; complete an investigation report if suspicious bruising has occurred or if there are patterns or trends of incidents that might constitute abuse; and determine if the direction of the investigation is appropriate.  CMS Ex. 7 at 12.

The policy emphasizes that the "facility must have evidence that all violations, including allegations, are thoroughly investigated."  CMS Ex. 7 at 13.  The results of the investigation must be reported to the facility administrator and to other officials, in accordance with state law (including the state survey and certification agency) within five working days of the incident.  If the violation is verified, appropriate corrective and disciplinary action must be taken.  Id.

The policy includes directions for protecting a resident during an investigation.  Id.

The policy reiterates the facility's reporting responsibilities:

• Incidents of alleged abuse, neglect, or misappropriation of resident property must be reported to the appropriate local, state, and federal agencies.
• All alleged violations involving mistreatment, neglect, or abuse, including injuries of unknown source, shall be reported immediately (not to exceed two hours after discovery) to the administrator or DON.

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• If neither the administrator nor DON is in the facility, the report is given to the charge nurse or supervisor.
• The charge nurse or supervisor must immediately contact the administrator or DON about the incident.
• The nurse must document all incidents of alleged abuse/neglect on the Incident Report and on the 24-hour report.
• All incident reports go directly to the administrator or, in the administrator's absence, to the DON.
• The administrator or designee immediately begins an investigation and follows state guidelines for reporting.  Investigation guidelines include:  resident and responsible party interviews; physical examination; staff interviews and written statements; collaboration with state agencies; and methods to support the individual and detect and prevent further victimization.
• All residents, family members, visitors, and others are encouraged to report incidents of resident abuse or suspected resident abuse.
• Such reports may be made without fear of retaliation from facility staff.
• The results of all investigations will be reported to the administrator or designee and other officials, in accordance with state law (including the state survey agency) within five working days of the incident.
• The administrator or designee analyzes occurrences to determine what policy changes, if any, are needed to prevent recurrences.
• The integrity of the investigation must be maintained at all times.

CMS Ex. 7 at 13-14.

Facility policy:  fall management system.  The facility had in place a policy requiring that each resident be assessed to determine the risk for falls and requiring that a care plan be implemented based on the resident's assessed needs.  CMS Ex. 7 at 1.

The policy explains that a fall occurs when "there is an unintentional coming to rest on the floor, ground, or other lower level but not as the result of an overwhelming external force," such as a push.  According to the policy, a fall without injury is still a fall.  Unless

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there is evidence suggesting otherwise, a fall is considered to have occurred whenever a resident is found on the floor.

The policy notes that a fall is often the result of cumulative risks from both "intrinsic" (resident-related) and "extrinsic" (environmental) factors.  Id.  The policy lists some intrinsic factors that contribute to the risk of falls, including:  muscular weakness, dizziness, confusion, vision and hearing impairments, depression, previous falls, and certain medications, including antihypertensives.  CMS Ex. 7 at 1-3.  Extrinsic factors are most likely seen in areas such as the bedroom, bathroom, dining room, and hallways and include:  mechanical restraints, poor lighting, inappropriate footwear, lack of handrails, wet floors, and loose rugs.  CMS Ex. 7 at 3.

The policy includes procedures for preventing falls.

• Identification.  First, the policy directs staff to identify the residents at risk.  On admission, quarterly, and when there is a significant change in the resident's status, a licensed nurse must complete a fall risk assessment that addresses the resident's mental status, ambulatory/elimination status, gait/balance, perceptual deficits, orthostatic blood pressure (systolic), falls history, medications, and predisposing diseases/conditions.
  
  The facility uses the Minimum Data Set (MDS) and Care Area Assessments (CAA) to assist in identifying a resident's risk for falls.
  
  A care plan is implemented for each resident at risk for falls.  CMS Ex. 7 at 3.
• Assess and implement.  The policy next advises staff to assess and implement preventive measures.  A resident who scores ten or above on the fall risk assessment may have a high risk for a fall.  Staff are to be advised of the identifying factors.  An individualized resident care plan is developed with appropriate goals and interventions.
  
  Residents who sustain falls may be referred to "therapy for screening," as indicated.
  
  The resident's level of risk may be "identified and communicated" on tools like care plans and assignment sheets.
  
  Preventive interventions are reviewed, evaluated, and implemented to reduce the recurrence of falls.

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Nursing and administration are responsible for validating and reevaluating residents at risk for falls and the effectiveness of interventions in the fall management program.  CMS Ex. 7 at 3-4.

• Document.  The policy requires that a licensed nurse complete an incident/accident report after each fall.  This report is not part of the medical record.  The licensed nurse will also document the fall in the nurses' notes.  This document must reflect that the legal representative and attending physician were notified.
  
  A licensed nurse must assess and document the resident's condition at least once per shift for at least 72 hours after a fall.  An unwitnessed fall is considered a potential head injury and requires neuro-checks.
  
  A "Resident Fall Tracking Log" must reflect each individual fall and is used for "analysis purposes."  An administrative nurse ensures that the fall is logged on the tracking log and entered on the "Incident Report QA/CQI (quality assurance/continuous quality improvement) form."  An administrative nurse must also ensure that the resident's care plan is revised to reflect the fall and the interventions implemented.  CMS Ex. 7 at 4.
• Investigate.  Finally, the policy requires that a licensed nurse initiate an incident/accident investigation immediately after each fall, using the facility's "Investigation Follow-up" guidelines.  Staff must implement interventions aimed at preventing additional falls.  Based on the results of the investigation, the licensed nurse must initiate intervention measures (such as a chair alarm, removing obstacles, placing the resident in a low bed) as soon as possible.  CMS Ex. 7 at 4-5.
  
  The policy recognizes that the facility administrator or DON might need to investigate further and document the findings on the "Investigation Synopsis."
  
  In their clinical meeting, the DON (or designee), administrator, and an Interdisciplinary Team (IDT) must review falls and may modify interventions to reduce the risk of falls.  Falls data and reports are reviewed at the Quality Assessment and Assurance (QAA) meetings.  Falls must also be reported as required by federal and state guidelines.  CMS Ex. 7 at 5.

Facility policy:  risk event guidelines.  The facility had a separate policy, titled "Risk Event Guidelines."  It calls for "timely resolution" of a high-risk situation, incident, or event that has resulted or is likely to result in serious physical, mental, or emotional harm to a resident, potential litigation, or misappropriation of resident property.  CMS Ex. 7 at 21.

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The policy provides that a "risk event" may require an immediate QAPI (Quality Assurance and Performance Improvement) rapid response and follow-up.  This "rapid response process" is a component of the Quality Assurance and Performance Improvement Program.  Situations elevated to the risk event process should be reviewed by the QAA committee.  Id.

The policy outlines a process:  1) identify the problem; 2) report; 3) establish facts; 4) validate and investigate facts; 5) implement an action plan; 6) evaluate progress and expand review; 7) track – document and finalize.  Id.

The policy also lists risks that are likely to cause harm:  burns, elopements, exploitation, sexually inappropriate behavior or allegation of consensual sex, mistreatment or allegation of mistreatment, adverse drug event, repetitive resident/family/responsible party concerns, weight loss, head trauma, resident to resident altercation, allegation of abuse, allegation of neglect, fall with serious injury, misappropriation of funds, drug diversion, fires, threatening conditions, heat stroke or exhaustion, death with unusual circumstances, unsafe smoking, choking, improper placement or injury from restraint or siderail, structure, air conditioning failure, heating failure, firearms in the building, suicide or attempt or verbalization, hypothermia, suffocation, insect bite.  CMS Ex. 7 at 21-22.

The policy lists the steps in the investigation process:

• A licensed nurse or other employee learns of the situation;
• The licensed nurse immediately evaluates the resident and addresses the event, as appropriate;
• The employee immediately notifies the immediate supervisor, administrator and DON;
• Immediate supervisor immediately notifies administrator and DON;
• Administrator and DON notify Regional Director of Operations and Regional Nurse Consultant; licensed nurse notifies physician, family or responsible party;
• "Preferably," an incident report or grievance form and other associated documents are completed;
• The administrator, as chair of the QAPI committee, oversees or leads the investigation.

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CMS Ex. 7 at 22.

Substantial noncompliance with 42 C.F.R. §§ 483.12 and 483.25(d).  The facts underlying the facility's failure to implement even basic steps to protect R1 from falls are undisputed, and, based on those facts, the facility was not in substantial compliance with sections 483.12 and 483.25(d).

From the time of her admission, it was apparent that R1 was at risk for falls.  She was weak, dizzy, and confused.  She was severely cognitively impaired.  She required supervision and a one-person physical assist for bed mobility, transfers, walking in her room, and using the toilet.  These are all factors that the facility identified – in its policies, the resident's assessment, and the resident's care plan – as putting her at risk for falls.  CMS Ex. 2 at 8-9; CMS Ex. 4 at 37-38, 61; CMS Ex. 7 at 1-3.  The facility's policy also recognized that poor lighting and inappropriate footwear could contribute to a resident's fall risk.  CMS Ex. 7 at 3.

R1's care plan directed staff to anticipate and meet her needs, to review information on past falls to determine their cause, and to alter or remove potential causes.  CMS Ex. 4 at 61.  The facility's policies required an administrative nurse to ensure that, after a fall, the resident's care plan is revised to reflect the fall and the interventions implemented.  CMS Ex. 7 at 4.

Nevertheless, R1 fell on April 2, 2022, because she had been "ambulating without assistance" or supervision.  CMS Ex. 4 at 100-101.  After the fall, staff did not follow the procedures called for in its policies.  They did not re-assess her risk for falls; they did not update her care plan.  They acknowledged that she fell while ambulating but did not further identify and record the root causes for her fall and, more importantly, did not alter or remove those causes.  No licensed nurse initiated new interventions.  CMS Ex. 2 at 10; CMS Ex. 4 at 52-87; CMS Ex. 7 at 4-5.

When R1 fell on July 11, 2022, staff again identified "ambulating without assistance" as a "predisposing situation factor."  This time, they added a specific intervention, aimed at preventing future falls:  "provide non-slip socks for resident."  CMS Ex. 4 at 103-105.

But the facility did not implement that or other interventions.  When R1 fell again, on July 29, 2022, "ambulation without assistance" and improper footwear are listed as factors contributing to the fall, along with clutter, poor lighting, and furniture, all factors listed in the facility's policies as increasing the risk of falls.  CMS Ex. 4 at 106-108.

On July 30, 2022, "ambulating without assistance," clutter, poor lighting, furniture, and improper footwear were again factors that contributed to the resident's fall.  CMS Ex. 4 at 109-110.

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Finally, the facility's July 30 fall risk assessment inaccurately reports that R1 had experienced only one or two falls in the preceding six months; in fact, she had fallen four times in four months (April 2, July 11, July 29, July 30).  CMS Ex. 4 at 39.

As the above discussion establishes, the facility did not implement the basic precautions that were called for in its fall management policy and R1's care plan.  It failed to provide R1 with the goods and services necessary to avoid her suffering physical harm; it did not provide her with the necessary care and services she needed to maintain her highest practicable physical, mental, and psychosocial well-being.  Her environment was not free of accident hazards, and the resident was not provided adequate supervision to prevent accidents.  "Ambulating without assistance" is repeatedly identified as a potential cause for her falls.  Yet, the facility did nothing to assure that she received the assistance she required while ambulating.  She was not even given non-slip socks.  These failures put the facility out of substantial compliance with sections 483.12 and 483.25(d).

Petitioner complains that the allegations of neglect under section 483.12 were "merely cut and pasted" from allegations of substantial noncompliance with section 483.25(d).  P. Br. at 4.  It is neither surprising nor uncommon for multiple deficiency citations to stem from a common set of facts, particularly 42 C.F.R. §§ 483.12 and 483.25.  After all, if a facility does not provide "the goods and services necessary" to avoid the resident's suffering physical harm, pain, mental anguish, or emotional distress (42 C.F.R. §§ 483.12, 483.5, 488.301), it necessarily fails to provide the "care and services" necessary to allow the resident "to attain or maintain the highest practicable physical, mental, and psychosocial well-being."  42 C.F.R. § 483.25.  See, e.g., Liberty Health & Rehab of Indianola, LLC, DAB No. 2434 at 12 (2011) ("Although Liberty objects that the ALJ relied on the same analysis to support his conclusion on noncompliance with all three cited requirements [abuse/neglect; quality-of care; administration], the Board has held that, in appropriate circumstances, a finding of noncompliance with section 483.75 [administration] may be derived from findings of noncompliance with other participation requirements."); Van Duyn Home & Hosp., DAB No. 2368 at 17 n.5 (2011) ("We also uphold the ALJ's conclusion that the same facts demonstrate noncompliance with 42 C.F.R. § 483.74 (administration) and 42 C.F.R. § 483.75(i) (medical director), given the fundamental responsibilities of the administration and the medical director to ensure systems and the medical director to ensure systems and policies protect residents' safety from foreseeable risks."); Jennifer Matthew Nursing & Rehab Ctr., DAB No. 2192 at 50 (2008) (affirming the ALJ determination that, "based on its care of R17 and of other residents during the heat wave, [the facility] was not in substantial compliance with sections 483.13(c) [then the abuse/neglect regulation], 483.25, and 483.75.").

Finding not material the question of whether LVN A fabricated assessment entries.  As discussed above, CMS came forward with evidence that LVN A neglected R1 after she suffered her last fall.  According to an investigating police officer, the nurse entered

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the resident's room only twice, even though he claimed to have assessed her condition eight times.  CMS Ex. 2 at 13-14, 24; CMS Ex. 4 at 188; CMS Ex. 6 at 22-23.  CMS is correct that these discrepancies suggest that R1 was neglected and raise serious concerns about the accuracy of the facility's records, generally.

In addition, a nurse aide complained that, even when he was in the resident's room, the LVN did not assess the resident.  In CMS's view – and I agree – failing to conduct the assessments constitutes neglect, which would put the facility out of substantial compliance with section 483.12.

For its part, although Petitioner criticizes the quality of CMS's evidence, it has tendered no evidence of specific facts (such as employee testimony, copies of its own video, or the police report) showing that a dispute exists.  See Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 586 n.11 (1986); Vandalia Park, DAB No. 1939 (2004); Lebanon Nursing & Rehab., DAB No. 1918 (2004).

With respect to CMS's evidence, Petitioner complains that CMS did not submit the police report.  P. Br. at 4-5.  The facility would have had access to that report and, in the process of investigating the allegations of abuse, should have obtained it.  But the facility either did not obtain it or obtained it and elected not to submit it.  More significant, the facility owned the underlying video, upon which the police report is based.  Yet, Petitioner did not submit that video.  In fact, the facility's administrator told Surveyor Hall that "it never occurred to him to look at the video."  CMS Ex. 6 at 25.

Arguably, however, LVN A's record entries, by themselves, create a material fact in dispute.  I would have to weigh that evidence against the evidence that those entries were fabricated, which could preclude my entering summary judgment.  But I need not find that LVN A failed to conduct neuro-checks in order to conclude that the facility was not in substantial compliance with section 483.12.  As discussed above, failing to provide R1 with the goods and services necessary to avoid her suffering physical harm, by itself, establishes that the facility neglected R1.¹²

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2. The facility did not provide to the state agency a report of its investigation of the incident that led to R1's injuries, which put the facility out of substantial compliance with 42 C.F.R. § 483.12(c).

Program requirement:  42 C.F.R. § 483.12(c) (Tag F609).  As part of the statutory and regulatory requirement to keep facility residents free from abuse and neglect, the facility must ensure that all alleged violations involving abuse or resulting in serious bodily injury are reported immediately, but not later than two hours after the allegation is made, to the facility administrator and to appropriate state officials.  If the events did not involve abuse or result in serious bodily injury, the alleged violations must be reported to the administrator and state officials not later than 24 hours after the allegation is made.  42 C.F.R. § 483.12(c)(1).

The facility must have evidence that all alleged violations are thoroughly investigated.  42 C.F.R. § 483.12(c)(2).  Within five working days of the incident, the facility must provide reports of all investigations to the facility administrator and to the state agency.  42 C.F.R. § 483.12(c)(4).

R1 was found, seriously injured, at approximately 3:00 a.m. on July 30.  The facility did not treat this incident as a situation of potential abuse or neglect and did not immediately report it to the state agency.¹³  Sometime thereafter, however, the resident's family accused facility staff of abusing the resident.  The record does not indicate when family members first leveled the accusations, but, on July 31, the facility Administrator called the state agency and reported that there had been an allegation of neglect (not abuse).  CMS Ex. 2 at 33.

The facility did not subsequently submit to the state agency a report of its investigation.  The report should have been submitted within five working days of July 30, 2022 (or no later than August 5, 2022).  On August 4, an investigator asked for the report, but it was not provided.  On August 17, the state agency again asked for the report.  It was not provided.  At 6:55 a.m. on August 19, the state agency sent an email request to the administrator, corporate nurse, and DON.  Although the administrator replied, "yes ma'am," no one produced the report.  CMS Ex. 2 at 33.  The facility has not yet produced the report of its investigation, not even as part of these proceedings.

Thus, the facility has not produced evidence that the alleged violations were thoroughly investigated, and it did not provide its report of the investigation to the state agency, which puts it out of substantial compliance with sections 483.12(c)(2) and 483.12(c)(4).

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A thorough investigation should identify the facility's underlying problems so that it can correct them and avoid future incidents.  For this reason, the facility's failure to report and investigate, by itself, may put it out of substantial compliance with the more general abuse and neglect regulation.  As the Board has explained, failing to report and investigate an allegation of abuse has broader implications, putting other facility residents at risk.  Beverly Health Care Lumberton, DAB No. 2156 at 15 (2008).  In affirming the Board's decision in Beverly, the Court of Appeals for the Fourth Circuit agreed that the facility's failure to implement its policies for reporting and investigating abuse "indicated a wider systemic problem in the facility" that leaves its residents "at real risk for serious harm."  Beverly Health Care Lumberton v. Leavitt, 338 F. App'x 308 at 314 (2009); Century Care of Crystal Coast, DAB No. 2076 at 25 (2007) (concluding that, where an incident went unreported and uninvestigated, the facility could not even identify, much less correct, the flaws in its systems.).

3. The undisputed evidence establishes that the facility was not in substantial compliance with 42 C.F.R. § 483.10(g)(14)(iii) because, without notice, and contrary to the facility's written policies, facility staff repeatedly changed a resident's room.

Program Requirement:  42 C.F.R. §§ 483.10(g)(14)(i)-(iv) and (15) (Tag F580).  The facility must promptly notify the resident and the resident representative, if any, when there is a change in room or roommate assignment.

Facility policy:  social services department – resident room relocation.  The facility had in place a policy governing resident room relocation.  It calls for social services involvement in all relocations of residents so that the resident's social, emotional, and cognitive needs are assessed prior to any relocation.

The policy directs social services staff to assess the impact of room relocation on the resident's psycho-social status based on:  the resident's ability to cope with and adapt to change; how the change will affect the resident's current relationships and social support systems; and the resident's willingness to move to a new location.

The social services staff are supposed to work with the interdisciplinary team to consider roommate compatibility and the resident's physical and care needs "to arrive at the most appropriate location for a resident."  CMS Ex. 7 at 15.

The policy directs social services staff to develop a plan to assure that the needs and concerns related to the resident's ability to cope and adjust to the relocation are addressed by taking the steps listed:

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• Providing the resident and legal representative or interested family member with verbal notice and documenting that notice in the medical record;
• Giving the resident the option of room, when possible;
• Introducing the resident to the new roommate;
• Informing the resident and legal representative when receiving a new roommate;
• Coordinating assistance in packing and moving belongings, as needed; and
• Addressing identified social, emotional, or cognitive needs related to room location.

Within seven days after the move, social services staff should make a follow-up visit or visits, as needed, to aid in the resident's adjustment to the new room.

Finally, the policy directs social services staff to document, in the medical record, the resident's response to the move.  CMS Ex. 7 at 16.

Resident 2 (R2).  R2 was a 74-year-old woman, initially admitted to the facility on December 18, 2019, and readmitted on June 4, 2022.  CMS Ex. 5 at 1.  She suffered from diabetes, dementia, major depressive disorder, muscle wasting, and weakness.  She had a history of falls.  CMS Ex. 5 at 1.¹⁴

According to her care plan, updated on July 20, 2022, the resident had impaired cognition and was at risk for further decline.  Among other interventions, the plan directed staff to "keep [her] routine consistent" in order to decrease her confusion.  CMS Ex. 5 at 28.

Without notice or social services involvement, R2 was moved four times in one month:

• June 30, 2022 – when readmitted to the facility, R2 was placed in Room 311B.
• July 10, 2022 – just ten days later, R2 was moved to Room 510A.

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• July 14, 2022 – four days later, R2 was moved to Room 508A.
• July 16, 2022 – two days later, R2 was moved to Room 301B.
• July 29, 2022 – 13 days later, R2 was moved to Room 310B.

CMS Ex. 2 at 5-6; CMS Ex. 5 at 47.  Such multiple moves can hardly be considered keeping the resident's routine "consistent."

In a note dated July 18 (when the resident was in Room 301B), the nurse reports that she noted a "raised area" on the resident's left temple.  The resident told her that she had fallen "several days ago" but she could not remember what room she was in when it happened.

On July 20 (when the resident was still in Room 301B), the nurse and nurse aide saw ants on R1's bed linens.  The nurse noted two small bumps on her inner right arm.  They consulted her daughter and asked if the resident could be moved to a different room so that Room 301B could be deep cleaned and sprayed by pest control.  The resident agreed to the move.  CMS Ex. 5 at 71-72.  For reasons that have not been explained, she was not moved, and, by July 24, nurses reported that she had "scattered, raised pustule areas" on her mid-back and both upper thighs.  The resident denied pain but complained of "slight itching."  CMS Ex. 5 at 71.

During this time, R2 exhibited significant behavior issues.  According to her care plan, dated July 20, 2022, she was refusing care; she would not take medications, allow vital signs to be taken, or allow labs to be drawn.  She would not allow staff to weigh or measure her and became verbally aggressive to staff who tried to provide care.  CMS Ex. 5 at 33.

On August 5, 2022, R2 asked to move back to Room 301.  The facility's administrator called to inform her daughter, and, on August 5, 2022, the resident was moved back to Room 301B.  CMS Ex. 5 at 69.

Petitioner has not responded to nor denied any of these facts.  The undisputed evidence thus establishes that the facility moved this already-confused resident from room to room without notice to her or her family and, contrary to its own policies, without any social services involvement.  The facility was therefore not in substantial compliance with section 483.10(g).

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4. The undisputed evidence establishes that CMS's determination that, for one day, the facility's substantial noncompliance posed immediate jeopardy to resident health and safety is not clearly erroneous.

Immediate jeopardy exists if a facility's noncompliance has caused or is likely to cause "serious injury, harm, impairment, or death to a resident."  42 C.F.R. § 488.301.  CMS's determination as to the level of a facility's noncompliance (which would include an immediate jeopardy finding) must be upheld unless it is "clearly erroneous."  42 C.F.R. § 498.60(c).  Once CMS presents evidence supporting a finding of substantial noncompliance, it need not offer evidence to support its immediate jeopardy determination.  The burden is on the facility to show that CMS's determination is clearly erroneous.  Woodland Oaks Healthcare Facility, DAB No. 2355 at 17-18 (2010); Grace Healthcare of Benton, DAB No. 2189 at 13 (2008), citing Liberty Commons Nursing & Rehab Center- Johnston, DAB no. 2031 at 17-18, aff'd, Liberty Commons Nursing & Rehab Ctr. – Johnston v. Leavitt, 241 F. App'x 76 (4th Cir. 2007).

The Board has observed repeatedly that the "clearly erroneous" standard imposes on facilities a "heavy burden" to show no immediate jeopardy and has sustained determinations of immediate jeopardy where CMS presented evidence from which "[o]ne could reasonably conclude" that immediate jeopardy exists.  Florence Park Care Ctr., DAB No. 1931 at 27-28 (2004), citing Koester Pavilion, DAB No. 1750 (2000); Daughters of Miriam Center, DAB No. 2067 at 7, 9 (2007); see Yakima Valley School, DAB No. 2422 at 8 (2011) (holding that the "clearly erroneous" standard is highly deferential and "places a heavy burden on the facility to upset CMS's finding regarding the level of noncompliance.").

Citing the Board decision in Daughters of Miriam Center, DAB No. 2067 (again, without providing any page numbers) and Appendix Q, a provision of the State Operations Manual, Petitioner argues that immediate jeopardy "has been interpreted" as a "‘crisis situation" in which the health and safety of individuals are at serious risk in the very near future."  P. Br. at 5-6.  Although the Daughters of Miriam decision mentions Appendix Q, it does not say that immediate jeopardy requires a crisis situation.  Instead, the Board recognized that distinguishing between the levels of noncompliance is necessarily imprecise and observed that this "inherent imprecision is precisely why CMS's immediate jeopardy determination, a matter of professional judgment and expertise, is entitled to deference."  Daughters of Miriam Center, DAB No. 2067 at 15.

Moreover, in subsequent decisions, the Board discouraged such reliance on the State Operations Manual, pointing out that its provisions are "instructive," but they are not binding.  Instead, we are bound by the regulatory definition of immediate jeopardy found in section 488.301.  Countryside Rehab. and Health Care, DAB No. 2853 at 25 (2018) ("[T]he imminence of resident harm is not an element of the regulatory definition of immediate jeopardy"); Kindred Transitional Care and Rehab - Greenfield, DAB No.

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2792 at 20 (2017); Miss. Care Ctr. of Greenville, DAB No. 2450 at 15-16 (2012); Foxwood Springs Living Ctr., DAB No. 2294 at 9 (2009).  That definition "neither defines the term ‘likelihood' nor sets any parameters as to the timing of potential harm."  Miss. Care Ctr., DAB No. 2450 at 16 (quoting Agape Rehab. of Rock Hill, DAB No. 2411 at 19 (2011)).  Thus, the Board has concluded that a facility's deficiencies may pose immediate jeopardy even though they do not create a "crisis situation."  Miss. Care Ctr., DAB No. 2450 at 16.¹⁵

That the facility's substantial noncompliance with section 483.12 posed immediate jeopardy to resident health and safety is not a close question.  The facility's failings were not only likely to cause R1 (and others) serious injury (or even death), those failings, in fact, caused her serious injury – substantial bruising, two spinal fractures, and significant pain – and required her hospitalization.  Before her July 30 fall, she was able to ambulate with assistance.  When she returned from the hospital, she was bedbound and minimally responsive.

The facility's deficiency under section 483.12 caused actual harm to a vulnerable facility resident and was likely to cause serious harm to others.  Petitioner has thus not met its burden of establishing that CMS's immediate jeopardy determination is clearly erroneous.

5. The penalties imposed – $23,989 per day for one day of immediate jeopardy and $245 per day for 16 days of substantial noncompliance that did not pose immediate jeopardy – are not unreasonably high.

To determine whether the CMP 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) 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.  The absence of culpability is not a mitigating factor.  The factors 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.

I consider whether the evidence supports a finding that the amount of the CMP is at a level reasonably related to an effort to produce corrective action by a provider with the kind of deficiencies found, and in light of the section 488.438(f) factors.  I am neither bound to defer to CMS's factual assertions nor free to make a wholly independent choice of remedies without regard for CMS's discretion.  Barn Hill Care Ctr., DAB No. 1848

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at 21 (2002); Cmty. Nursing Home, DAB No. 1807 at 22 et seq. (2002); Emerald Oaks, DAB No. 1800 at 9 (2001); CarePlex of Silver Spring, DAB No. 1638 at 8 (1999).

I determine whether a penalty is reasonable based on the per-day penalty, not the total accrued penalty.  Vibra Hospital at Charleston, DAB No. 3094 at 30; Crawford Healthcare and Rehabilitation, DAB No. 2738 at 20.

The burden is on the facility to demonstrate that a reduction is necessary to make the CMP amount reasonable.  Heritage Plaza Nursing Ctr., DAB No. 2017 at 22 (2017).

Penalties are inflation-adjusted and change annually.  The amount is determined as of the date the penalty is assessed, in this case, December 22, 2022.  CMS Ex. 1; 87 Fed. Reg. 15100, 15111-15112 (Mar. 17, 2022).  For one day of immediate jeopardy, CMS imposed a penalty of $23,989, which is at the top of the penalty range for situations of immediate jeopardy ($7,317 to $23,989).  CMS imposed a penalty of $245 per day for the period of substantial noncompliance that did not pose immediate jeopardy, which is at the very low end of the range ($120 to $7,195).  42 C.F.R. §§ 488.408(e), 488.438; 45 C.F.R. § 102.3; 87 Fed. Reg. 215111-15112 (Mar. 17, 2022).

CMS presents no evidence of the facility's compliance history.¹⁶

Except to claim that "no evidence" establishes that CMS considered the facility's financial condition and to argue, paradoxically, that no regulatory requirement compels the facility to provide financial information, Petitioner does not claim that it is unable to pay the penalty.  In fact, the burden is on the facility to demonstrate, through argument and evidence addressing the regulatory factors, that a reduction is necessary to make the CMP reasonable.  Vibra Hospital of Charleston, DAB No. 3094 at 30; Crawford Healthcare, DAB No. 2738 at 19.

Applying the remaining factors, I have discussed in some detail the facility's significant failure to provide R1 with the services she needed to prevent physical harm.  Despite her multiple falls, facility staff failed to take even simple precautions to keep her safe.  Not only did they fail to provide her with the level of assistance that her assessment and care plan called for, they did not keep her environment clutter-free; they did not provide her with adequate footwear.

A resident was seriously hurt; her family was alleging abuse.  A police officer cited evidence of neglect.  Yet, the facility has produced no evidence that it thoroughly investigated the incident, a shortcoming that indicates a "wider systemic problem in the facility" that leaves its other residents "at real risk for serious harm."  Beverly Health Care Lumberton v. Leavitt, 338 F. App'x 308 at 314-315; Century Care of Crystal Coast,

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DAB No. 2076 at 25 (2007).  And, notwithstanding the state agency's repeated requests, the facility has refused to produce a report of any investigation.  These deficiencies, for which the facility is fully culpable, posed immediate jeopardy to resident health and safety and more than justify the one-day $23,989 penalty.¹⁷

In addition to its failing to provide its residents with the goods and services needed to keep them safe and its failing to provide residents with a safe environment and adequate supervision, the facility moved one of its residents from room to room, without notice, explanation, planning, or follow-up.  This disregard for the resident's rights is particularly disturbing because the confused resident required a consistent routine.  For this, the facility is also culpable.

This and the other deficiencies that did not pose immediate jeopardy to resident health and safety more than justify the minimal $245 per-day penalty.

Conclusion

From August 29 through September 14, 2022, the facility was not in substantial compliance with Medicare program requirements, and, on August 29, 2022, its deficiencies posed immediate jeopardy to resident health and safety.  The penalties imposed – $23,989 per day for one day of immediate jeopardy and $245 per day for 16 days of substantial noncompliance that did not pose immediate jeopardy – are reasonable.

Endnotes

¹  As I explained in the order, although the federal rules do not apply directly to these administrative proceedings, in considering summary judgment, I am "procedurally and substantively guided by Rule 56."  Civil Remedies Division Procedures § 19; see Livingston Care Ctr. v. U.S. Dep't. of Health & Human Servs., 388 F.3d 168, 172 (6th Cir. 2004).

²  Page 28 is a page from an incident report prepared by facility staff.  I'm assuming Petitioner did not mean to include it in its objections to the pictures.

³  Deciding a case on summary judgment (or based on the written record) does not mean that it is decided without a hearing, and, in applying the principles of summary judgment to administrative proceedings, courts have been careful to avoid any suggestion that the case is decided without a hearing.  Throughout their decisions, they refer to deciding the case without an "oral hearing" or without an "evidentiary hearing."  Although a case may be decided on summary judgment (or based on the written record), an administrative law judge, by considering the evidence and applying the law, has granted the petitioner a hearing, as required by sections 205(b) and 1866(h) of the Act.  See 42 C.F.R. § 498.66(d) (on conducting a hearing without oral testimony); CNG Transmission Corp. v. FERC, 40 F.3d 1289, 1293 (D.C. Cir. 1994) (holding that a "paper hearing" satisfies statutory requirements for "notice and opportunity for hearing.").

⁴  My findings of fact/conclusions of law are set forth, in italics and bold, in the discussion captions of this decision.

⁵  As discussed below, CMS proffered evidence – which Petitioner did not counter – that at least one staff member recorded the results of assessments that he could not have performed.  R1's daughter also complained that staff did not contact her until R1 had fallen for the third time.  As discussed below, I need not resolve these issues in order to decide this case.

⁶  The nurse aide told Surveyor Clavion Hall that she knew that she was not supposed to move the resident before the resident was assessed but did so because the resident was in so much pain and begged her to do it.  CMS Ex. 8 at 3-4 (Hall Decl. ¶ 10).

⁷  A document titled "investigation follow-up" provides no additional information, with many questions left unanswered.  CMS Ex. 4 at 19-20.

⁸  R1's daughter told hospital staff that her mother had suffered three falls before the hospital contacted her at 3:00 a.m. to tell her that her mother had fallen, and they were sending her to the emergency room.  CMS Ex. 4 at 140.

⁹  The family was obviously very unhappy with the care provided to R1.  While at the hospital, her daughter asked staff to discharge her to a different facility.  She explained that, due to her own illness, she had not been able to visit her mother daily, and that the quality of care provided had declined.  Hospital staff explained that such a transfer might take up to 30 days.  CMS Ex. 4 at 133.  Within days of the resident's return to the facility, however, she had died.

¹⁰  Curiously, even though these assessments were purportedly performed through the night, the resident is never described as drowsy, much less asleep.

¹¹  The nurse aide's timing of this visit to R1's room is consistent with the investigating police officer's observations.

¹²  CMS argues that the facility was not in substantial compliance with 42 C.F.R. § 483.70(i) (Tag F842) because LVN A failed to ensure that R1's neuro-checks were documented accurately.  CMS Br. at 17-18.  I need not reach this issue because the deficiency findings that I have sustained more than justify the penalties imposed.  See Perry Cty. Nursing Ctr. v. U.S. Dept. of Health and Human Services, 603 F. App'x. 265, 271 (2015); Claiborne-Hughes Health Ctr. v. Sebelius, 609 F.3d 839, 847 (2010); Carrington Place of Muscatine, DAB No. 2321 at 20-21 (2010); Senior Rehab. and Skilled Nursing Ctr., DAB No. 2300 at 6 n.5 (2010), aff'd Senior Rehab. and Skilled Nursing Ctr. v. HHS, No. 10-60241 (2011); see also 42 C.F.R. § 498.3(b)(13) (limiting review to findings that result in CMS imposing a penalty).

¹³  I am unable to determine whether the facility should have reported the incident immediately, as required by 42 C.F.R. § 483.12(c)(1).  However, CMS has not pursued the issue.

¹⁴  Progress notes show that R2 fell on June 2, 2022.  While on the ground, she called her daughter, who, in turn called the facility to report that her mother was on the ground.  Staff noted that the resident's bed alarm was not fully plugged in.  CMS Ex. 5 at 13, 18.  On June 17, 2022, R2 fell again, while attempting to use the bedside commode.  This time she called the facility to report her fall.  CMS Ex. 5 at 11.  On August 4, she was again found on the floor, with a quarter-sized knot on her forehead.  She told staff that she hit her head on the floor.  CMS Ex. 5 at 70.  Although disturbing, CMS has not argued that these instances put the facility out of substantial compliance.

¹⁵  This approach comports with the Supreme Court's comments as to the value of sub-regulatory guidance.  See Azar v. Allina Health Servs., 139 S. Ct. 1804 (2019).

¹⁶  Petitioner incorrectly asserts that CMS submitted a survey history.  P. Br. at 7.

¹⁷  Indeed, considering staff's inadequate response to the resident's April 2 fall and its ongoing refusal to produce evidence of its investigation (if any), CMS could have justified a multi-day penalty of $23,989, extending from April 2 through August 29, 2022.