Lock Haven Rehabilitation & Senior Living, DAB CR6622 (2025)

DECISION

Petitioner, Lock Haven Rehabilitation & Senior Living, is a long-term care facility located in Lock Haven, Pennsylvania that participates in the Medicare program.  Disregarding a physician’s order and the facility’s policies, one of the facility’s nurse aides did not use a gait belt when helping a 97-year-old resident walk from the shower room back to her own room.  The resident fell and was subsequently diagnosed with a fractured hip and clavicle (collarbone).

Thereafter, the Centers for Medicare & Medicaid Services (CMS) determined that the facility was not in substantial compliance with 42 C.F.R. § 483.12, which provides that each resident be free from abuse, neglect, and exploitation.  To motivate the facility to maintain substantial compliance, CMS imposed a per-instance civil money penalty (CMP) of $12,600.

Petitioner appealed, and CMS has moved for summary judgment, which Petitioner opposes.

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I grant CMS’s motion.  The undisputed evidence establishes that the facility was not in substantial compliance with section 483.12 and that the penalty imposed is reasonable.

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, responding to a complaint, surveyors from the Pennsylvania Department of Health (state agency) conducted a complaint investigation survey, which they completed on March 1, 2023.  CMS Exs. 1, 2, 5; see CMS Ex. 24 at 2 (Berguson Decl ¶ 6).  Based on the survey findings, CMS determined that the facility was not in substantial compliance with 42 C.F.R. § 483.12(a) (Tag F600 – freedom from abuse, neglect, and exploitation), 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).  CMS Ex. 2.

CMS has imposed against the facility a per-instance CMP of $12,600.  CMS Ex. 2 at 2.

Petitioner timely requested a hearing.  CMS moves for summary judgment, which Petitioner opposes.

Exhibits.  With its motion and brief (CMS Br.), CMS submits 24 exhibits (CMS Exs. 1‑24).  With its brief in opposition (P. Br.), Petitioner submits 12 exhibits (P. Exs 1-12).

I consider the proffered evidence to determine whether it creates a material fact in dispute but need not admit the exhibits into the record.  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) (holding that an ALJ must review

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all proposed exhibits submitted in support of or in opposition to a motion for summary judgment; the ALJ is not required to admit those exhibits into the record).  The exhibits are “properly treated as an offer of proof,” to be evaluated, as necessary, to determine whether a genuine issue of material fact exists.  Id.

Issues

As a threshold matter, I consider whether summary judgment is appropriate.

On the merits, the issues before me are:  

• was the facility in substantial compliance with 42 C.F.R. § 483.12;1 and
• if the facility was not in substantial compliance with section 483.12, is the $12,600 per-instance penalty reasonable?

Scope-and-severity.  Petitioner also challenges CMS’s scope-and-severity determination.  P. Br. at 2, 23.  I have no authority to review scope-and severity in this case.  The regulations authorize such review if:  (1) a successful challenge would affect the range of the CMP; or (2) CMS has made a finding of substandard quality of care that results in the loss of approval of the facility’s nurse aide training program.  42 C.F.R. §§ 498.3(b)(14), 498.3(d)(10); 38-40 Freneau Avenue Operating Company, LLC, d/b/a Atrium Post Acute Care of Matawan, DAB No. 3008 at 11-12 (2020); Madison Cnty. Nursing Home, DAB No. 2895 at 16 (2018); NMS Healthcare of Hagerstown, DAB No. 2603 at 6-7 (2014); Cedar Lake Nursing Home, DAB No. 2344 at 9 (2010); Heritage Park Rehab. & Nursing Ctr., DAB No. 2231 at 15-16 (2009); Evergreen Commons, DAB No. 2175 (2008); Aase Haugen Homes, Inc., DAB No. 2013 (2006).

For a per-instance penalty, the regulations provide only one range, so the level of noncompliance does not affect the range of the CMP.  42 C.F.R. § 488.438(a)(2).

With respect to the second factor, certain types of deficiencies, including “abuse, neglect, and exploitation” (42 C.F.R. § 483.12), can lead to a finding of “substandard quality of care.”  The deficiency must be cited at one of the following scope-and-severity levels:

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• immediate jeopardy;
• a pattern of or widespread actual harm that is not immediate jeopardy; or
• widespread deficiencies with the potential for more than minimal harm.

42 C.F.R. § 488.301.  Because a G-level deficiency is isolated, CMS could not – and did not – find substandard quality of care.

In any event, even if CMS had been able to find substandard quality of care, its scope-and-severity finding would not be reviewable because of the amount of the penalty.  If (as here) I approve a penalty of $11,995 or more, CMS’s scope-and-severity finding does not affect approval of its nurse aide training program (assuming it has one).  Under the statute and regulations, the state agency cannot approve the program if CMS imposes a penalty of $11,995 or more.  Thus, the facility would lose its approval without regard to the scope-and-severity finding.  Act § 1819(f)(2)(B); 42 C.F.R. § 483.151(b)(2)(iv); 87 Fed. Reg. 15,100, 15,120 (March 17, 2022).

CMS’s scope-and-severity finding (level G) is therefore not reviewable.2

Survey performance.  Petitioner builds much of its case around purported survey inadequacies.  See P. Br. at 10-14, 17-20, 23 (suggesting that, contrary to provisions of the State Operations Manual, the surveyor did not “consider all sources of evidence”).

Allegations of inadequate survey performance are irrelevant to ALJ or Board review of CMS’s noncompliance and remedy determinations.  42 C.F.R. § 488.318(b) (providing that inadequate survey performance does not relieve the facility of its obligation to meet all program requirements or invalidate adequately documented deficiencies); Avon Nursing, DAB No. 2830 at 2, 11 (2017), (holding that the survey agency’s purported failure to comply with provisions of the Medicare statute did not invalidate CMS’s noncompliance determination or enforcement remedy), aff’d on other grounds, Avon Nursing & Rehab. v. Becerra, 114 F.4th 286 (2d Cir. 2024).

[T]he ultimate issue before an ALJ is not how the state agency performed the survey or what process it followed to reach its conclusions, but “whether the evidence as it is developed before the ALJ supports” CMS’s independent “finding of noncompliance” under the relevant participation requirements.

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Avon Nursing, DAB No. 2830 at 11 (quoting Sunshine Haven of Lordsburg, DAB No. 2456 at 21 (2012), aff’d in part and transferred, Sunshine Haven Lordsburg v. U.S. Dep’t of Health & Human Servs., 742 F.3d 1239 (10th Cir. 2014)).3

Moreover, I reject Petitioner’s repeated complaints that the surveyor did not interview specific employees or review certain facility records.  See, e.g., P. Br. at 10-13.  The facility has access to all of its own records and to its employees.  If it determined that relevant evidence should be considered, it was free to submit any of those records or witness declarations.  See Batavia Nursing & Convalescent Ctr., DAB No. 1904 (2004), aff’d. 129 F. App’x 181 (6th Cir. 2005).

Discussion

Summary judgment.  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” of the Federal Rules of Civil Procedure.  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).

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. 2652 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).4

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What evidence I must consider.  Rule 56 provides that, in determining whether material facts are in dispute, I am required to consider only the material facts cited by the parties in support of or opposition to the motion.  However, I “may consider” other materials submitted. Fed. R. Civ. P. 56(c)(3); accord Administrative Procedures Act, 5 U.S.C. § 556(d) (providing that a rule or order be based on consideration of the whole record or those parts cited by a party and supported by reliable, probative, and substantial evidence).

What the parties must show.  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., 388 F.3d at 173 (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.  Heritage House of Marshall Health and Rehab., DAB No. 3035 at 8 (2021); 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.  Vibra Hospital of Charleston – TCU, DAB No. 3094 at 11 (2023); 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

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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).

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); see Cedar Lake Nursing Home, 619 F.3d 453, 457-58 (affirming summary judgment that was based on the ALJ’s “specific, undisputed findings of fact,” accepting as true the facts presented by the Petitioner).

Principles of summary judgment applied to this case.  No issues in this matter “would benefit from being resolved in an evidentiary hearing.”  CMS’s case rests on specific, undisputed facts, so one-sided that it must prevail as a matter of law.

Although Petitioner gratuitously asserts that “multiple relevant issues of material fact” are in dispute (P. Br. at 20), it tenders no evidence of specific facts showing that a dispute exists.  Instead, it submits written declarations from the facility’s Director of Nursing (DON), Heidi Frank (P. Ex. 11), and from Nurse Consultant Gail Rader (P. Ex. 8), claiming that “[t]he definition of neglect has a connotation not applicable to the carefully articulated facts raised by the analyzing witness, which correlates with the factual statements and the investigation of the facility’s Director of Nursing.”  P. Br. at 20.5

To the contrary, DON Frank offers no new material facts and points to no facts that Petitioner disputes.  P. Ex. 11 (Frank Decl.).  For her part, Nurse Consultant Rader, who has no independent knowledge of what happened, accepts the facts asserted by CMS and opines that those facts do not establish that the facility was not in substantial compliance with section 483.12.  See P. Ex. 8 (Rader Decl.) and discussion below.  Whether the

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undisputed facts establish that the facility was not in substantial compliance with Medicare requirements is a legal – not a factual – conclusion and does not preclude summary judgment.  Vibra Hospital of Charleston – TCU, DAB No. 3094 at 11; W. Tex. LTC, DAB No. 2652 at 6-7; Bartley Healthcare Nursing and Rehab., DAB No. 2539 at 8 (holding that summary judgment is not inappropriate merely because the parties proffer differing opinions on the ultimate legal issue); cf. Guardian, DAB No. 1943 at 11.  I am not bound to accept a witness’s legal conclusions.  See Beatrice State Development Ctr., DAB No. 2311 at 12-14 (2010) (affirming that the ALJ decides the legal issues).

1. The undisputed evidence establishes that, in assisting an ambulating resident, a nurse aide did not follow facility policy requiring her to review the resident’s electronic profile and did not provide the resident with a physician-ordered gait belt.  Because staff did not provide the resident with the goods and services necessary to avoid her suffering physical harm and pain, the facility was not in substantial compliance with section 483.12.6

Program requirement:  42 C.F.R. § 483.12 (Tag F600).  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.

“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.

Facility policies.  A facility is out of substantial compliance with the anti-neglect regulation if it fails to follow its policies and procedures that define what the facility deems “the goods and services necessary to avoid physical harm.”  Avalon Place Kirbyville, DAB No. 2569 at 9 (2014).

Facility policy:  reviewing resident profiles.  The facility maintained an electronic medical record system.  Each resident had an electronic profile, which contained orders for care, including the resident’s ambulation and transfer status.  For each resident and each shift, the profile identified specific tasks that staff were to perform.  The caregiver was required to read each assigned resident’s profile each shift and, at the beginning of each shift, to sign off on a document indicating that she had done so.  “Everyone must do this with Every Resident!”  CMS Ex. 1 at 5; CMS Ex. 7 at 11-12; CMS Ex. 22 at 1, 7-8; CMS Ex. 24 at 5-6 (Berguson Decl. ¶ 16); see CMS Ex. 7 at 3; CMS Ex. 12 at 16.

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Facility policy:  proper use of gait belts.  The facility had in place a policy describing the proper use of gait belts.  The policy explains that a gait belt is used to prevent injury to a resident and to staff.  It allows staff to control the resident at the resident’s center of gravity, giving greater control over the resident’s balance.  P. Ex. 2 at 1.

The policy directs staff to “know these points” before ambulating: 

• The amount of assistance the resident requires, which can range from supervision to maximum assistance, and the number of staff members needed to provide that assistance;
• Any assistive devices the resident uses (standard walker, wheeled walker, quad cane, hemi-walker); and
• The distance the resident is able to ambulate safely before fatiguing.

P. Ex. 2 at 2.

The policy provides a pre-ambulation checklist and describes the procedures for using the gait belt.  P. Ex. 2 at 1-3.

Resident 1 (R1).  Resident 1 (R1) was a 97-year-old woman, originally admitted to the facility on October 3, 2012, suffering from non-Alzheimer’s dementia, Alzheimer’s disease, psychotic disturbance, mood disturbance, anxiety, osteoporosis, chronic kidney disease, and other disorders.  She suffered from muscle weakness and had abnormalities of gait and mobility.  She had difficulty walking.  CMS Ex. 6 at 1; CMS Ex. 10 at 1, 12; P. Ex. 3 at 1.

According to an assessment, dated February 3, 2023, R1 could not undergo a Brief Interview for Mental Status (BIMS) because she was rarely or never understood, and she rarely or never understood verbal content.  Her vision was moderately impaired.  She had memory problems and could not recall basic facts about her living situation.  CMS Ex. 10 at 3, 4.  She exhibited physical behavioral symptoms directed toward others (hitting, kicking, pushing, scratching, grabbing).  CMS Ex. 10 at 5; P. Ex. 4 at 4, 6, 9.

R1 was totally dependent on staff for bathing and toileting.  CMS Ex. 10 at 8.  She was incontinent.  CMS Ex. 10 at 10.  She required extensive assistance (two or more nurse aides) with bed mobility, transfers, and walking in her room.  CMS Ex. 10 at 6-7.  According to the assessment, she required supervision when walking in the corridor and off the unit.  To walk 10 feet or more, she required substantial to maximal assistance.  CMS Ex. 10 at 8.

She had not experienced any falls.  CMS Ex. 10 at 13.

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Physician order.  On July 19, 2021, responding to R1’s having sustained an injury (a bruise), R1’s physician ordered that she ambulate with hand-held assistance and a “black gait belt.”  CMS Ex. 7 at 9; P. Br. at 4.  A gait belt wraps around the resident’s waist.  Based on the physician’s order, staff were required to hold R1’s hand and to hold the gait belt, keeping R1 steady as she walked.  CMS Ex. 24 at 4-5 (Berguson Decl. ¶ 13); see P. Ex. 2 at 1.

R1’s fall.  The circumstances surrounding R1’s fall are not disputed.  At about 5:30 a.m. on February 22, 2023, she fell in the hallway in front of the shower room.  She had been returning to her room following her shower.  She was not wearing her gait belt, which was back in her room, hanging on the back of the door.  CMS Ex. 6 at 4; CMS Ex. 7 at 3, 5, 20; CMS Ex. 11 at 2; P. Ex. 4 at 1; P. Ex. 11 at 2 (Frank Decl. ¶ 8).

Petitioner asserts that “[i]t is unknown why the gait belt was not brought to the shower room prior to the incident” but faults the surveyor for not generating any interview notes with the facility employees explaining why the gait belt was not used.  P. Br. at 17.  In fact, the facility is at fault for not determining why the gait belt was left hanging from the door in the resident’s room rather than being used to ambulate the resident.  CMS met its burden by establishing that the gait belt was not used.7  The burden then shifted to the facility to establish (if it can) why the belt’s absence was justified.  See Batavia Nursing & Convalescent Ctr., DAB No. 1904, aff’d, 129 F. App’x 181 (6th Cir. 2005); Hillman Rehab. Ctr., DAB No. 1611 at 8 (1997), aff’d, Hillman Rehab. Ctr. v. U.S. Dept. of Health and Human Servs., No. 98-3789 (GEB) 1999 WL 34813783 (D.N.J. May 13, 1999).

Further, in investigating the incident, the facility should have determined the extent of staff’s disregard for a physician order and facility policies, which includes finding out why the gait belt was not taken to the shower room and who was responsible for that omission.  42 C.F.R. § 483.12(c)(2) (requiring that all alleged violations be thoroughly investigated); see, e.g., Century Care of Crystal Coast, DAB No.2076 at 25 (concluding that, without a thorough investigation, the facility could not even identify, much less correct, the flaws in its system).  Failing to determine why the gait belt was left behind further weakens the facility’s claim that it provided the residents with the goods and services necessary to avoid physical harm and pain.

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According to the nurse aide responsible for returning R1 to her room (Nurse Aide # 1),

I was walking [R1] back to her room when she pulled away from me to grab [the] bar on the wall.  Then she went down to the floor.  She then [sat] up and tr[ied] to get up.

CMS Ex. 7 at 6.  A second nurse aide observed the incident and confirmed this account.  CMS Ex. 7 at 7; P. Ex. 4 at 1.

Nurse Aide # 1 had not checked R1’s medical record, was not aware of the physician order for a gait belt, and the resident’s belt was not anywhere nearby.  CMS Ex. 1 at 5; CMS Ex. 8 at 2, 4.  Nurse Aide # 1 asked her supervisor, a licensed practical nurse (LPN), what the resident’s ambulation status was.  The LPN did not check the medical record and did not tell the nurse aide to check the medical record.  Instead, she told the nurse aide, “I’ve seen them take her to the bathroom and shower with only one person.”  When DON Frank asked the LPN whether she told the nurse aide to check R1’s medical record, the LPN said, “‘No, that’s how they usually do it,’ implying that they usually know to check transfers and ambulation if they are unsure.”  CMS Ex. 7 at 3, 20.

In her written declaration, DON Frank does not deny that the LPN made the statement nor claim that it wasn’t true.  P. Ex. 11.  The LPN did not submit a written declaration.  The statement may therefore be considered reliable, and it may constitute substantial evidence.  Omni Manor Nursing Home, DAB No. 1920 at 11 (2004); 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).

That, as reported by DON Frank, the LPN based her instructions on her observations of staff taking R1 to the shower room “with only one person” weakens the facility’s position even more.  As Petitioner concedes, either the LPN had not observed staff using a gait belt, or, if she had, she didn’t mention it.  Either possibility raises disturbing questions about whether staff consistently used the gait belt.  If they had, the LPN would presumably have noticed and so advised Nurse Aide # 1.  No one from the facility has come forward with evidence suggesting that staff consistently followed the physician order.

Staff assessed R1 and initially determined that she was not injured – which turned out to be incorrect.  CMS Ex. 6 at 4; CMS Ex. 7 at 3.8  Later that day, R1 showed signs and

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symptoms of left shoulder pain.  X-rays revealed that her distal left clavicle was fractured.  CMS Ex. 6 at 4; CMS Ex. 7 at 3, 17; CMS Ex. 11 at 2; P. Ex. 4 at 1.  The next day, staff noted swelling on the left side of R1’s face, and she exhibited symptoms of leg pain (guarding, saying “ouch” when her legs were moved).  Additional x-rays showed that that her left hip was fractured.  CMS Ex. 7 at 16; CMS Ex. 11 at 2.

R1’s family decided against surgery; she was treated with comfort care and morphine.  CMS Ex. 11 at 1.  R1’s physician ordered an immobilizer sling for the resident’s left arm, to be removed only for providing hygiene.  Her physician also changed her transfer status to a Hoyer lift, non-weight bearing, and changed her ambulation order to non-ambulation.  CMS Ex. 22 at 1.

In investigating the fall, the facility determined that Nurse Aide # 1 had not followed a physician order and that she required re-education.  CMS Ex. 7 at 5.  In a report to the state agency, the facility characterized the incident as “neglect” and indicated that Nurse Aide # 1 was “removed from care.”  CMS Ex. 8 at 2, 4.  Facility management subsequently suspended her, citing her “failure to follow” physician’s orders, “resulting in severe resident harm.”  CMS Ex. 7 at 20.  Again, in her written declaration, DON Frank does not deny any of this.  P. Ex. 11.

Staff practices.  Surveyor Gail Berguson interviewed other nurse aides who provided care to facility residents.  Some told her that they did not consistently review the resident profiles before providing care, but, because they worked with the residents all the time, they knew the residents’ needs.  According to some of the nurse aides, they didn’t have time to review the profiles for all the residents they care for.  CMS Ex. 22 at 7-8.

One nurse aide told Surveyor Berguson that she did not know how to access the resident profiles.  CMS Ex. 22 at 4.

Again, Petitioner has not presented the testimony of any of these employees denying that they made the statements or claiming that the statements are untrue.  The statements may therefore constitute substantial evidence.  Omni Manor Nursing Home, DAB No. 1920 at 11; Beatrice State Development Ctr., DAB No. 2311 at 17, 18.

The facility’s substantial noncompliance.  A physician order and the facility’s policies describe the goods and services that R1 needed to avoid physical harm and pain:

• The physician ordered a gait belt and hand-held assistance while ambulating.  CMS Ex. 7 at 9.
• One facility policy required that “[e]veryone” read the electronic profile of “[e]very [r]esident” for whom they cared.  CMS Ex. 7 at 11-12.

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• A second policy required that, before assisting a resident with ambulation, the caregiver determine, among other points (amount of assistance needed, distance the resident could safely ambulate), which assistive devices she required.  P. Ex. 6 at 2.

Staff did not follow the physician order nor these policies.

The Board has determined that failing to follow a physician order can put the facility out of substantial compliance with Medicare requirements.  Cedar Lake Nursing Home, DAB No. 2390 at 3 (holding that a facility’s failure to comply with physician orders or its own policies can constitute a deficiency under section 483.25); Woodland Village Nursing Ctr., DAB No. 2053 at 9 (2006), aff’d, Woodland Village Nursing Ctr. v. U.S. Dep’t of Health & Human Servs., 239 F. App’x 80 (5th Cir. 2007) (citing Lakeridge Villa Health Care Ctr., DAB No. 1988 at 22 (2005), aff’d, Lakeridge Villa Health Care Ctr. v. Leavitt, 202 F. App’x 903 (6th Cir. 2002)).

Similarly, it is well-settled that a facility’s failure to follow its policies or procedures supports a finding of noncompliance with the anti-neglect regulation (section 483.12) where, as here, the policies “determine what the facility deems the ‘goods and services necessary to avoid physical harm.’”  Avalon Place, DAB No. 2569 at 9 (citing Azalea Court, DAB No. 2352 at 13-15 (2010)) (“The fact that the regulations do not specify that a particular type of care is necessary to meet a requirement does not prevent a finding of noncompliance when the facility itself has determined what type of care is necessary.”); see Liberty Commons Nursing & Rehab. Ctr. – Johnston v. Leavitt, 241 F. App’x 76 (4th Cir. 2007); Hanover Hill Health Care Ctr., DAB No. 2507 at 18 (2013).

The nurse aide responsible for returning R1 to her room was not aware of the physician order for a gait belt nor that R1 required any assistive device.  Contrary to the facility’s explicit policies, she did not consult R1’s electronic profile.  Instead, she asked the supervisory LPN what, if anything, R1 required.  The LPN did not know about the physician order, did not suggest that the nurse aide check the electronic record, and offered (incorrect) advice, based on her earlier observations (which apparently did not include staff using a gait belt when they ambulated with R1).

Because she was not supported by a gait belt, R1 was able to pull away from Nurse Aide # 1, resulting in her falling and sustaining serious injuries.  Thus, facility staff did not provide the resident with the goods and services she needed to avoid suffering physical harm and pain.  The facility itself characterized the incident as “neglect.”  CMS Ex 8 at 2.  Because R1 was not free from neglect, the facility was not in substantial compliance with section 483.12.

Petitioner’s defenses.  Petitioner raises a series of defenses, which I reject for the reasons explained below:

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• Pointing to Appendix PP of the State Operations Manual, Petitioner argues that citing the facility for neglect is improper because “[t]here is nothing to indicate the facility failed to act to protect the rights of the resident or was neglectful of [R1] as required” by the State Operations Manual.  P. Br. at 16, 24; P. Ex. 8 at 17-20 (Rader Decl. ¶¶ 72-80).
  
  For more than two decades, the Board has flatly refused to use the sub-regulatory guidance provided to surveyors in the State Operations Manual (and elsewhere) to alter the plain language of the regulations.  The provisions of the State Operations Manual may be “instructive” but they are not binding.  Consulate Healthcare of Jacksonville, DAB No. 3119 at 17 (2023); Countryside Rehab. and Health Care, DAB No. 2853 at 25 (2018); Kindred Transitional Care and Rehab. – Greenfield, DAB No. 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); Oakwood Community Ctr., DAB No. 2214 at 16 (2008); Aase Haugen Homes, Inc., DAB No. 2013 at 15 (2006); Alden-Princeton Rehab. & Health Care Ctr., DAB No. 1873; Beverly Health and Rehab. Ctr. – Williamsburg, DAB No. 1748 at 8 (2000), aff’d, Beverly Health and Rehabilitation Servs. v. Thompson, 223 F. Supp. 2d 73, 99-106 (D.D.C. 2002).
  
  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).
• Petitioner points out that Nurse Aide # 1 had not been assigned to care for R1.  She was merely assisting the assigned nurse aide by showering R1, and the assigned nurse aide had, in fact, signed the form indicating that at she had reviewed the resident profile.  P. Ex. 6 at 6; P. Ex. 11 at 2 (Frank Decl. ¶ 6); P. Br. at 5.  This does not excuse the facility.  First, every staff member who provides care must provide the resident with necessary goods and services.  Second, assuming that the assigned nurse aide reviewed R1’s profile and knew about the physician order, either she did not share that information with Nurse Aide # 1, or she told Nurse Aide # 1 about the order, and Nurse Aide # 1 disregarded the information.9  Either scenario means that the facility was not providing R1 with necessary goods and services and therefore violated section 483.12.
• Petitioner also lists the steps that Nurse Aide # 1 took that were not neglect (asking the nurse what the R1’s ambulatory status was; putting nonslip socks on her) and argues that these gestures establish that she was not neglectful.  P. Br. at

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17.  Just because staff were not neglectful in every respect – which staff seldom are – does not mean that they did not neglect R1 in other critical respects.

• Petitioner points out that Nurse Aide # 1 asked the supervisory LPN what R1’s ambulation orders were and suggests that she was simply following her supervisor’s (incorrect) directions.  P. Ex. 11 at 2 (Frank Decl. ¶¶ 10, 12); P. Br. at 6.  CMS does not dispute this, and I accept the assertion as true.  But, if anything, this fact weakens Petitioner’s case.  It shows that the facility’s neglect of R1 was not limited to the errors of one staff member but was more systemic, involving at least two nurse aides and the supervising nurse.
• Petitioner argues that the facility should not be held accountable because Nurse Aide # 1 had successfully completed the facility’s orientation program just two weeks before the incident.  P. Br. at 19.  Whether the facility had properly trained its staff is not material where, as here, “there is undisputed evidence that staff did not act on that education and training.”  Avalon Place Kirbyville, DAB No. 2569 at 11.  Moreover, the Board has consistently maintained that a facility may not disavow the errors of its staff and may properly be held responsible for their actions.  Madison County, DAB No. 2895 at 8-9 (2018); Kindred Transitional Care, DAB No. 2792 at 10; Springhill Senior Residence, DAB No. 2513 at 15 (2013) (citing Beverly Health Care Lumberton, DAB Ruling No. 2008-5 (Denial of Petition for Reopening Decision No. 2156) at 6-7 (2008)); Gateway Nursing Ctr., DAB No. 2283 at 8 (2009); North Carolina State Veterans Nursing Home, Salisbury, DAB No. 2256 (2009); Emerald Oaks, DAB No. 1800 at 7 n.3 (2001).
• R1 attended physical therapy sessions from January 26 through February 8, 2023, and, based on the therapist’s conclusions, Petitioner suggests that the facility is somehow less accountable because R1’s fall risk was due to “the need for obstacle avoidance and directional changes because of cognition” rather than her “functional ability to safely ambulate in the hallway.”  P. Br. at 11; P. Ex. 5 at 3 (pointing out that the resident’s “task completion” is “highly limited” due to her cognitive impairment.)  P. Ex. 8 at 7 (Rader Decl. ¶ 32).  Petitioner does not explain this leap in logic.
  
  I find irrelevant the underlying reason for R1’s vulnerability here.  The facility recognized that she was at risk; her physician identified the goods and services she needed to avoid suffering physical harm and pain.  The facility developed policies aimed at insuring that staff familiarized themselves with what was required so that they could provide it.  They did not do so.
• Finally, Petitioner suggests that the gait belt might not have prevented R1’s fall. Her physician thought otherwise, which was why he ordered the belt.  The facility’s own investigation concluded otherwise, finding that the nurse aide’s

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failing to follow the physician order resulted in resident harm.  P. Ex. 11.  Had R1 been ambulated properly – with a staff member holding her hand and keeping her steady by holding the gait belt – she could not so easily have pulled away from the nurse aide, leading to her fall and injury.  CMS Ex. 24 at 4-5 (Berguson Decl. ¶ 13); P. Ex. 2 at 1.

In any event, the question is irrelevant.  First, I need not find actual harm in order to find that the facility was not in substantial compliance.  A facility is not in substantial compliance if its deficiencies pose no greater risk to resident health and safety than “the potential for causing minimal harm.”  42 C.F.R. § 488.301.  Second, similar to the quality-of-care regulation (42 C.F.R. § 483.25), section 483.12 focuses on whether the facility has provided the goods and services necessary to avoid suffering.  If the facility is not providing the necessary goods and services, CMS need not wait until a resident suffers actual physical harm and pain before it can cite a deficiency.  See Kenton Healthcare, DAB No. 2186 at 13; accord, Fal-Meridian, 604 F.3d at 447.

2. The penalty imposed is reasonable.

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; Crawford Healthcare, DAB No. 2738 at 19 (2016).

Determining whether the penalty is reasonable.  To determine whether a civil money penalty 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 at

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

The burden is on the facility “to demonstrate, through argument and submission of evidence addressing the regulatory factors, that a reduction is necessary to make the CMP amount reasonable.”  Heritage Plaza Nursing Ctr., DAB No. 2829 at 22 (2017) (quoting Oaks of Mid City Nursing and Rehab. Ctr., DAB No. 2375 at 26-27 (2011)).

Penalties are inflation-adjusted and change annually.  The amount is determined as of the date the penalty is assessed, in this case, March 24, 2023.  CMS Ex. 2; 87 Fed. Reg. 15,100, 15,111 (Mar. 17, 2022).  Here, CMS imposed a per-instance CMP of $12,600, which is in the mid-range for per-instance penalties ($2,400 to $23,989).  42 C.F.R. §§ 488.408(e), 488.438; 45 C.F.R. § 102.3; 87 Fed. Reg. at 15,111-12 (Mar. 17, 2022).

Applying the criteria to this case.  With respect to whether the CMP is reasonable, Petitioner has proffered no evidence creating a dispute about facts affecting how the regulatory factors should be assessed.  CMS is therefore entitled to summary judgment on the issue.  Vibra Hospital, DAB No. 3094 at 30; Crawford Healthcare, DAB No. 2738 at 19.

In any event, considering the relevant factors, CMS has established that $12,600 is a reasonable amount.

CMS submits the facility’s recent enforcement history.  This evidence (unchallenged by Petitioner) establishes that the facility has a less-than-stellar history.  CMS Ex. 3.10

• For a Life Safety Code survey completed on December 21, 2022, the facility had a significant number of violations (seven), all cited at scope and severity level E (pattern of substantial noncompliance that causes no actual harm with the potential for more than minimal harm).  CMS Ex. 3 at 1.
• For a survey completed on November 18, 2022, the facility was not in substantial compliance with section 483.25 (Tag F689 – quality-of-care), cited at scope and severity level G; and sections 483.15(d) (Tag F625 – notice of bed hold policy), 483.24(a) (Tag F677 – quality-of-life:  providing necessary care and services to dependent residents), and 483.60(i) (Tag F812 – food and nutrition services:  food safety), all cited at scope-and severity level E.  CMS Ex. 3 at 1.

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• A complaint investigation, completed on June 21, 2022, found that facility was not in substantial compliance with 42 C.F.R. § 483.80 (Tag F 884 – infection control:  failing to report), cited at scope-and-severity level F (widespread substantial noncompliance that causes no actual harm, with the potential for more than minimal harm).  CMS Ex. 3 at 2.
• For a survey completed on December 10, 2021, the facility was not in substantial compliance with section 483.30(a) (Tag F353 – nursing services:  sufficient staff), cited at scop-and-severity level E; and sections 483.25 (Tag F688 – quality-of-care:  mobility) and 483. 60 (Tag F804 – food and nutrition services:  nutritional adequacy), both cited at scope and severity level E.  CMS Ex. 3 at 2.
• For a survey completed on November 19, 2020. The facility was not in substantial compliance with section 483.25(g) (Tag F321 – quality-of-care: assisted nutrition and hydration), cited at scope and severity level E.  CMS Ex. 3 at 2.

The facility’s history alone justifies imposing a CMP that is substantially greater than the minimum.  See H.R. Rep. No. 100-391(I), 100th Cong., 1st Sess. (1987) (expressing the goal of eliminating the “yo-yo” or “roller coaster” phenomenon); Florida Agency for Health Care Admin, v. Bayou Shores SNF, LLC, 2016 WL 3675462 at 19 (11th Cir. July 11, 2016); Heartland Manor at Carriage Town, DAB No. 1664 (1998).

Petitioner does not claim that its financial condition affects its ability to pay the CMP.

With respect to the remaining factors, I consider the deficiency here very serious.  R1 suffered two serious fractures.  As a result, she became non-weight bearing and was no longer able to ambulate at all.  CMS Ex. 22 at 1.  Even if I agreed that a gait belt would not have prevented the resident’s fall, I would consider very serious staff’s failing to check a resident’s medical record and failing to follow a physician order.  For this elderly and infirm population, failing to provide the goods and services necessary to prevent physical harm can have severe, even fatal, consequences.  Yet facility staff disregarded the resident’s identified need for an assistive device.  For this, the facility is culpable and the penalties imposed are reasonable.

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Conclusion

For all of these reasons, I find that the facility was not in substantial compliance with 42 C.F.R. § 483.12 and that the penalty imposed – $12,600 per instance – is reasonable.