Allaire Rehab & Nursing, DAB CR6685 (2025)

DECISION

Petitioner, Allaire Rehab & Nursing, is a long-term care facility, located in Freehold, New Jersey, that participates in the Medicare program. Violating a physician order, one of its at-risk residents left the facility, unsupervised. Although staff observed his departure, they did nothing to ensure his safety. The facility’s management learned of the departure an hour-and-a-half later, when the resident’s sister called to report that the resident was in a hospital emergency room. He had been hit by a car.

The Centers for Medicare & Medicaid Services (CMS) subsequently determined that the facility was not in substantial compliance with Medicare program requirements, including 42 C.F.R. § 483.25(d) (accident prevention) and that the deficiency cited under that regulation posed immediate jeopardy to resident health and safety. Based on the survey findings, CMS imposed remedies: a $9,485 per-day civil money penalty (CMP) for 20 days of immediate jeopardy and a $225 per-day CMP for 35 days of substantial noncompliance that did not pose immediate jeopardy.

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

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For the reasons set forth below, I grant CMS’s motion; Petitioner has not come forward with evidence that (if believed) would show that it did everything possible (within the meaning of the regulation) to minimize the risks of accidents. The undisputed evidence establishes that the facility was not in substantial compliance with Medicare program requirements, that its deficiencies under section 483.25(d) posed immediate jeopardy to resident health and safety, and that the penalties imposed are 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).

In this case, surveyors from the New Jersey State Department of Health (state agency) went to the facility to investigate a resident’s purported elopement and injury. They completed their complaint investigation survey on January 13, 2021. CMS Exs. 1, 2; CMS Ex. 10 at 2 (Mysklinski Decl. ¶ 3). Based on the survey findings, CMS determined that the facility was not in substantial compliance with the following Medicare participation requirements:

• 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. § 483.12(c)(2)-(4) (Tag F610 – freedom from abuse, neglect, and exploitation: reporting and investigation), cited at scope-and-severity level D;
• 42 C.F.R. § 483.21(b)(2) (Tag F657 – comprehensive care plans: timing, development, and revisions), cited at scope-and-severity level D;

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• 42 C.F.R. § 483.21(b)(3) (Tag F658 – comprehensive care plans: meeting professional standards of quality), cited at scope-and-severity level D;
• 42 C.F.R. § 483.25(d) (Tag F689 – quality of care: accident prevention), cited at scope and severity level J (isolated instance of substantial noncompliance that poses immediate jeopardy to resident health and safety).

CMS Ex. 1; CMS Ex. 2 at 1.

Thereafter, CMS determined that the facility returned to substantial compliance on February 12, 2021. CMS Ex. 2 at 2.

Based on the deficiency cited under section 483.25(d), CMS has imposed against the facility a CMP of $9,485 per day for 20 days of immediate jeopardy (December 19, 2020 through January 7, 2021) and $225 per day for 35 days of substantial noncompliance that did not pose immediate jeopardy (January 8 through February 11, 2021) (Total: $189,700 + $7,875 = $197,575). CMS Ex. 2 at 2.

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

CMS has filed a motion for summary judgment and brief in support (CMS Br.), along with 12 exhibits (CMS Exs. 1-12). Petitioner filed its brief in opposition (P. Br.), with 19 exhibits (P. Ex. 1-19).

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 sub nom. Gorovits v. Becerra, No. 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 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 are:

• From December 19, 2020, through February 11, 2021, was the facility in substantial compliance with 42 C.F.R. § 483.25(d);

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• If, from December 19, 2020, through January 7, 2021, the facility was not in substantial compliance with section 483.25(d), did this deficiency then pose immediate jeopardy to resident health and safety; and
• If the facility was not in substantial compliance with section 483.25(d), are the penalties imposed – $9,485 per day for 20 days of immediate jeopardy and $225 per day for 35 days of substantial noncompliance that did not pose immediate jeopardy – reasonable?

Deficiency findings that are not reviewable here. Petitioner challenges the remaining cited deficiencies. P. Br. at 2. I have no authority to review those determinations. A facility’s hearing rights are established by federal regulations, 42 C.F.R. Part 498. A facility dissatisfied with an initial determination is entitled to further review, but administrative actions that are not initial determinations are not subject to appeal. 42 C.F.R. § 498.3(a) and (d). The regulations specify which actions are “initial determinations” and provide examples of actions that are not. With an exception not applicable here, a finding of noncompliance that results in CMS imposing a remedy specified in section 488.406 is an initial determination for which a facility may request a hearing before an administrative law judge. 42 C.F.R. § 498.3(b)(13). But a facility has no right to a hearing unless CMS imposes one of the specified remedies. San Fernando Post Acute Hosp., DAB No. 2492 at 7-8 (2012); Columbus Park Nursing & Rehab. Ctr., DAB No. 2316 at 7 (2010); Lutheran Home – Caledonia, DAB No. 1753 (2000); Schowalter Villa, DAB No. 1688 (1999). The remedy, not the citation of a deficiency, triggers the right to a hearing. Schowalter Villa, DAB No. 1688 at 3. Here, CMS imposed remedies for the deficiency cited under section 483.25(d) only. The remaining deficiencies, for which no remedies were imposed, are not reviewable.

Petitioner’s complaints about surveyor performance. Petitioner complains about purportedly “egregious” errors in “how the survey was conducted,” how information was gathered, and “the surveyor’s ultimate decision to cite the facility” based on an “incorrect interpretation of the facts.” P. Br. at 2. Elsewhere, Petitioner suggests that CMS cannot prevail because the surveyors violated the regulations, “the guidelines that interpret them,” and the State Operations Manual, “which dictates how surveyors must go about performing a survey.” Petitioner also charges that the surveyors did not consider “all sources of evidence.” P. Br. at 23.

Petitioner mischaracterizes the role of the surveyor in the nursing home survey process. Surveyors investigate facility conditions; they interview staff and residents, review pertinent records, and generally gather evidence as to whether a facility complies with program requirements. See CMS Ex. 10 at 1 (Mysklinski Decl. ¶ 1). However, CMS, not the individual surveyor nor even the state agency, ultimately decides whether a deficiency should be cited. 42 C.F.R. § 488.452(a)(2). And even if the surveyor errs (I see no evidence of that here), inadequate survey performance does not invalidate

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adequately documented deficiencies. 42 C.F.R. § 488.318(b); 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); see Avon Nursing & Rehab. v. Becerra, 114 F.4th 286 (2d Cir. 2024) (agreeing that the absence of registered nurses from the survey team did not invalidate survey findings).

[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.

Avon Nursing at 11 (quoting Sunshine Haven of Lordsburg, DAB No. 2456 at 21, 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)).

Whether the surveyor adequately considered provisions of the State Operations Manual is irrelevant. 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 (2003); Beverly Health and Rehab. Ctr. – Williamsburg, DAB No. 1748 at 8 (2000), aff’dBeverly Health and Rehabilitation Services v. Thompson, 223 F. Supp. 2d 73, 99-106 (D.D.C. 2002).

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. Ctr., DAB No. 2703 at 5 (2016); W. Tex. LTC Partners, Inc., DAB No. 2652 at

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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.

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 in 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. 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. 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 Hosp. of Charleston – TCU, DAB No. 3094 at 11 (2023); W. Tex. LTC Partners, 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

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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).

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. This is simply wrong. As Judge Posner of the Seventh Circuit Court of Appeals has explained: “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 at 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).

In Fal-Meridian, the Seventh Circuit considered specifically the appropriateness of granting CMS summary judgment in a nursing home case involving (then) section 483.25(h) (now section 483.25(d)).1 The court sustained the administrative law judge’s granting summary judgment in CMS’s favor because the petitioner/nursing home did not tender “evidence that, if believed, would show that it had done everything possible (within the meaning of the regulation) to minimize the risks of an accident.” Fal-Meridian, 604 F.3d at 451. The relevant questions are: 1) whether the facility’s “handling of [the resident’s] physical and mental infirmities was consistent with its duty to keep the [facility] free as possible from hazards that might cause an accident,” and 2) if not consistent, whether the facility’s dereliction of its duty was likely to cause serious injury, harm, impairment, or death to a resident. Fal-Meridian, 604 F.3d at 447.

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I note that courts that have considered applying principles of summary judgment to Medicare and other administrative proceedings have carefully avoided any suggestion that deciding a case on summary judgment means that it 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.”).

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. Petitioner responds with legal arguments and evidence of facts that are not material to this decision. Ultimately, CMS is entitled to summary judgment because Petitioner presents no admissible evidence of specific facts showing that it did everything possible to minimize the risks of an accident.

1. CMS is entitled to summary judgment because the facility did not tender evidence showing that it did everything possible (within the meaning of 42 C.F.R. § 483.25(d)) to minimize the risks of accidents posed to a vulnerable resident.2 

Program requirement: 42 C.F.R. § 483.25(d) (Tag F689). Quality of care “is a fundamental principle that applies to all treatment and care provided to facility residents.” 42 C.F.R. § 483.25.

The statute and regulation require 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); 42 C.F.R. § 483.25.

To this end, the “quality of care” regulation mandates, among other requirements, that the facility “ensure” that each resident’s environment remain as free of accident hazards as possible and that each resident receive adequate supervision and assistive devices to prevent accidents. 42 C.F.R. § 483.25(d). The facility must eliminate or reduce a known

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or foreseeable risk of accidents “to the greatest degree practicable.” Del Rosa Villa, DAB No. 2458 at 7 (2012); Clermont Nursing & Convalescent Ctr., DAB No. 1923 at 9-10 (2004), aff’d sub nom. Clermont Nursing & Convalescent Ctr. v. Leavitt, 142 F. 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 that meet his or her assessed needs and mitigate foreseeable risks of harm from accidents”). A facility is permitted the flexibility to choose the methods it uses to prevent accidents, but the chosen methods must constitute an “adequate” level of supervision under all the circumstances. 42 C.F.R. § 483.25(d); Windsor Health Care Ctr., DAB No. 1902 at 5 (2003), aff’d sub nom. Windsor Health Care Ctr. v. Leavitt, 127 F. App’x 843 (6th Cir. 2005).

Where a facility policy or a resident’s care plan requires staff to take specific measures in caring for a resident, those measures reflect the facility’s own determination of what it must do to attain or maintain the resident’s “highest practicable physical, mental, and psychosocial well-being” as required by the overarching quality-of-care requirement.” Heritage Plaza Nursing Ctr., DAB No. 2829 at 6 (2017). The facility is not in substantial compliance with section 483.25(d) if, without justifiable reason, it does not implement the accident precautions that its staff has determined are necessary to mitigate foreseeable accident risks. Good Shepherd Home for the Aged, DAB No. 2558 at 14 (2018).

Facility policies. The facility had in place a “WANDERING/ELOPEMENT POLICY.” Its objective was “to ensure the safety and protection of wandering residents by preventing their exit from the building.” CMS Ex. 7 at 9.

The policy lists five purposes:

• To identify residents who may be potential wandering and elopement risks and to establish a procedure when a resident does elope.
• To identify at risk or hazardous areas inside and outside of the facility.
• To implement a plan for conducting a community search.
• To implement procedures in response to door alarm and elopement incidents.
• To maintain resident monitoring/security devices.

The policy’s next section is titled, “Policy Interpretation and Implementation.” It provides as follows:

1. Upon admission, quarterly, annually, and when there is a significant change in status, the resident will be assessed for wandering/elopement risk, using the “Elopement Risk” form. Any resident identified to be at risk for wandering, either by preadmission history and/or observed behavior, will be provided with a Wanderguard, and an appropriate plan of care will be developed.

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2. A resident identified as at risk for elopement/wandering will be placed on “Elopement Risk Protocol” and referred to the individual responsible for ensuring that the resident’s picture is on the “wander list.”

1. A picture of the resident will be kept at the reception desk and nursing station.
2. Secure a name band for proper identification.
3. A Wanderguard bracelet will be applied.
4. Alert staff.
5. A care plan addressing the issue will be developed.

CMS Ex. 7 at 9.

3. If a high-risk resident is noted at the lobby area, the receptionist will call the unit for nursing assistance. The receptionist may announce “CODE GREY – DR. WALKER” (location) over the public address system to alert staff, if necessary.

CMS Ex. 7 at 9-10.

4. When a resident is suspected missing or is unaccounted for, the following procedures will be followed:

1. The supervisor or designee will immediately notify Nursing Administration and advise them of the time the resident was last seen.
2. “CODE GREY – DR. WALKER” will be announced over the public address system.
3. An organized, thorough facility-wide search will be conducted under the direction of the supervisor. The search will include all resident rooms, bathrooms, stairwells, basement, laundry rooms, and common rooms.
4. An exterior search will be conducted at the same time, with particular attention to high risk areas, i.e., driveway, parking lot, woods/bushes, busy streets, drainage areas, etc.

5. If the resident is not found within 30 minutes, notify the family or responsible party and attending physician of the elopement and the progress of the search.

6. Notify the local police department. Provide a complete description of the resident and the time the resident was last seen.

If it’s the weekend, evening, or holiday, and the resident is not found within 15 minutes, the supervisor will notify the Director of Nursing (DON), who, in turn, will notify the administrator.

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The administrator or, in his/her absence, the DON will notify the Office of the Ombudsman and/or Director of Health & Senior Services if the resident is not found within two hours.

7. After locating the resident, an incident report must be completed and the incident must be documented in the nurse’s notes.

When the resident returns to the facility:

a) Complete a body check and nursing assessment to verify the absence of injuries;

b) Apply a Wanderguard (if not already in use);

c) Develop an appropriate care plan to prevent a recurrence of the elopement;

d) Notify the resident’s responsible party and the attending physician if the resident requires any treatment.

8. Refer any inquiry by a newspaper, television, or radio to the facility administrator. Other personnel are NOT to give out any information.

CMS Ex. 7 at 10.

Out-on-pass unaccompanied policy. The facility had a separate policy that addressed residents leaving the facility unaccompanied. It states that the facility’s mission is “to maintain the residents’ highest practicable level of independence[,] resident rights, and safety” when a resident leaves the facility unaccompanied. The policy’s purpose is described as “to facilitate resident’s safety and respect for resident rights.” CMS Ex. 7 at 11.

The policy provides that, unless otherwise specified by a physician, a competent resident may exercise his or her right to leave the facility unaccompanied by staff, after completing the following procedure:

1. Review the resident responsibility to sign in and out every time he leaves the facility
2. Sign the “Resident Education: Leaving Unaccompanied” form, which is placed in in the MDS (minimum data set) portion of the resident’s medical record, and which delineates the potential risks the resident may incur, including, but not limited to:

a. Suffering a medical emergency and not being able to receive prompt medical treatment.

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b. Impact of disability on protecting the resident from potential injury and/or attack.

c. Mechanical difficulties and safety issues related to operating a wheelchair.

3. Notify the nursing staff prior to leaving the facility. If the resident has a cell phone, the number should be provided to staff, as should an alternative means of contact. The resident must document the information on the OOP (Out-on-Pass) form, and nursing staff must validate.

Based on the MDS, care conference, and/or other resident-specific information, the interdisciplinary team and “rehab” may make recommendations regarding the resident’s ability to leave the facility safely, when unaccompanied.

Should a resident’s right to leave the facility unattended be restricted for any reason, the nurse must obtain a physician order indicating that.

CMS Ex. 7 at 11.

Policy on investigating and reporting accidents and incidents. The facility policy requires that staff investigate and report to the facility administrator all accidents or incidents involving residents, employees, visitors, vendors, or others, that occur on the premises. CMS Ex. 7 at 1.

The Nurse Supervisor/Charge Nurse and/or the department director or supervisor must “promptly initiate and document [an] investigation of the accident or incident.”

As applicable, the following data must be included on the “Report of Incident/Accident” form:

1. The date and time the accident or incident took place;
2. The nature of the injury/illness (e.g., bruise, fall, nausea, etc.);
3. The circumstances surrounding the accident or incident;
4. Where the accident took place;
5. The name(s) of witnesses and their accounts of the accident or incident;
6. The injured person’s account of the accident or incident;
7. The time the injured person’s attending physician was notified, as well as the time the physician responded and his or her instructions;
8. The date/time the injured person’s family was notified, and by whom;
9. The condition of the injured person, including vital signs;
10. The disposition of the injured (i.e., transferred to the hospital, put to bed, sent home, returned to work, etc.);
11. Any corrective action taken;
12. Follow-up information;

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13. Other pertinent data, as necessary or required; and
14. The signature and title of the person completing the report.

According to the policy, the facility “is in compliance with current rules and regulations governing accidents and/or other incidents involving a medical device.”

The policy directs the Nurse Supervisor/Charge Nurse and/or the department director or supervisor to complete a “Report of Incident/Accident” form and submit the original to the DON within 24 hours of the incident or accident.

For each occurrence, the DON must ensure that the Administrator receives a copy of the “Report of Incident/Accident” form. CMS Ex. 7 at 1.

Resident 3 (R3). R3 was a 48-year-old man, admitted to the facility on June 19, 2020, suffering from a long list of serious ailments: Pick’s Disease;3 severe major depressive disorder with psychotic symptoms; psychosis; anxiety disorder; obsessive-compulsive disorder; chronic post-traumatic stress; epilepsy; history of traumatic brain injury; chronic viral hepatitis; Porphyria;4 chronic obstructive pulmonary disease; and gastro-esophageal reflux disease. CMS Ex. 5 at 1-2, 230.

At the time of his admission, R3 was described as alert and oriented to person, place, and situation. The assessor could not determine whether he was oriented to time. P. Ex. 3 at 1. His cognition was intact. Id. at 2, 7. He admitted to smoking but did not respond to questions about alcohol or drug use. The assessor described his behavior as “resistive.” Id. at 2. He was anxious. Id. at 4. He was independent with most activities of daily living except dressing and bathing, for which he required the assistance of staff. Id. at 10.

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He complained of mild pain. Id. at 11; but see P. Ex. 10 at 28 (complaining of “very severe, horrible” pain).

R3’s mood was depressed. He often felt tired or had little energy. P. Ex. 10 at 9. Although his initial assessment identified verbal and other behavioral symptoms directed toward others, it concluded that those symptoms did not put him or others at risk. P. Ex. 10 at 11. This turned out not to be completely accurate. R3 subsequently demonstrated that his behaviors put him and others at considerable risk.

Moreover, notwithstanding some of these initial findings, the assessment also concluded that a significant number of care areas were triggered. These included: cognitive loss/dementia (due to his behaviors and diagnoses of PTSD and Pick’s disease); activities of daily living (due to his need for assistance); psychosocial well-being; mood; behavioral symptoms; falls; pain; and other areas. P. Ex. 10 at 47.

R3 resided in the facility’s Horizons Neurological Unit for residents with brain injuries. CMS Ex. 5 at 230; see P. Ex. 12.

R3 had deficits in performing activities of daily living related to his impaired standing balance, coordination, and problem-solving skills. CMS Ex. 5 at 23. He apparently sprained his left ankle in June 2020, which further limited his physical mobility and continued to affect him, at least through December 2020. CMS Ex. 5 at 24.

Medications. R3 was prescribed a long list of medications. See CMS Ex. 5 at 3-16. These included the following:

For his psychosis, anxiety, and depression: Depakote; Klonopin; Paxil; Seroquel; Zyprexa; and Olanzapine.

To control his seizures: Lamotrigine and Topiramate.

To control his pain: Oxycodone-Acetaminophen (Vicodin).

CMS Ex. 5 at 13-16.5 R3’s medications put him at risk for falls. CMS Ex. 5 at 30.

R3 would pocket or hide his pills. CMS Ex. 5 at 29. Because of this and other erratic behaviors, nurses were instructed to crush all his prescribed narcotics. CMS Ex. 5 at 26, 28, 31.

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Wandering Risk. At the time of his admission in June 2020, an assessment rated R3 at low risk for wandering (scoring a 4). P. Ex. 5. By October, that had changed. An assessment, dated October 5, 2020, identified R3 as a wandering risk (scoring 9). CMS Ex. 5 at 215-16. Yet, no changes were made to his care plan to address the increased risk. A follow-up assessment, dated December 20, 2020 (the day after his accident), also identified him as a wandering risk (again scoring 9).

R3’s behaviors. R3 did not sleep well and preferred to drink coffee throughout the day and night. His care plan recognized that his sleep habits put him at risk of injury related to inadequate sleep. CMS Ex. 5 at 22. He “wandered aimlessly.” He also went into resident rooms, behind the nurses’ station, and into locker rooms, taking the personal property of residents and staff. CMS Ex. 5 at 27.

R3 was a smoker, and many of his significant behavior problems related to his smoking.6 CMS Ex. 5 at 218-19. When agitated, he would light a cigarette inside the facility, violating the facility’s smoking policy. CMS Ex. 5 at 5. The record includes multiple examples of his problematic smoking-related behaviors:

• September 5, 2020. R3 was smoking in his room all night. CMS Ex. 5 at 131.
• October 7, 2020. Staff found R3 smoking in his room. CMS Ex. 5 at 110.
• October 8, 2020. R3 “continue[d] to go down to first floor and break open doors to smoke in the break area multiple times a shift.” He was also found going into the staff bathroom and other resident rooms. When asked not to, he began screaming and cursing, threatening nurse aides, using racial slurs. Staff called security, and the resident returned to his room. However, the nurse and nurse aide noted that the hall outside his room smelled like smoke. CMS Ex. 5 at 110.
• October 10, 2020. R3 kicked open a secured door to get out to the courtyard to smoke. He is described as “noncompliant [with] smoke breaks.” CMS Ex. 5 at 106.
• October 12, 2020. R3 exited his room yelling and banging on the wall because the nurse said that his room smelled of cigarette smoke. CMS Ex. 5 at 105.
• November 14, 2020. Staff described R3’s room as smelling of cigarette smoke. CMS Ex. 5 at 100.

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R3 also smoked marijuana and repeatedly tested positive for Cannabinoids. CMS Ex. 5 at 204-06.

• September 14, 2020. Staff smelled marijuana smoke in the resident’s room. CMS Ex. 5 at 122; see CMS Ex. 5 at 206 (testing positive for Cannabinoid).
• October 2, 2020. R3’s speech was slurred. He was disoriented, walking into walls, his eyes closed. His physician ordered a urine drug screen and put a 24-hour hold on his narcotics. CMS Ex. 5 at 113-14; see CMS Ex. 5 at 204 (testing positive for cannabinoids).

R3 could be verbally aggressive, related to his ineffective coping skills and mental/emotional illness. CMS Ex. 5 at 26.7 He was also physically aggressive, which was related to his poor impulse control. He would spit, punch, slap, or kick staff and other residents. His progress notes describe these and other significant behaviors and incidents, including those that required police intervention. Among them are the following:

• September 4, 2020. R3 threw a cigarette butt and coffee at another resident (who was in a motorized wheelchair). When a staff member reported him, R3 tried to hit the staff member, until a nurse intervened to prevent it. R3 also slapped another resident. Ultimately, staff called the police, who took him to the emergency room. CMS Ex. 5 at 132.

On September 6, 2020, R3’s physician ordered that, for five days, staff observe him hourly and separate him from his peers, as needed, to prevent physical and verbal altercations. CMS Ex. 5 at 11.

According to a psychiatric progress note, dated September 8, 2020, R3 showed signs of severe anxiety, depression, and aggression. His thinking was tangential and circumstantial. He was forgetful. He had mood swings, preoccupations, and was notably “paranoid,” with delusions. His attention was fair; his speech showed decreased latency. His insight, judgment, and impulse control were poor-to-fair. CMS Ex. 5 at 198.

• September 19, 2020. After R3 had physical and verbal altercations with multiple staff members, they called the police, and the resident was taken away for an evaluation. The nurse reports that she later observed a broken computer, as well as broken dishes and food, on the floor. CMS Ex. 5 at 119.

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• September 23, 2020. R3 again destroyed facility property and threatened staff. CMS Ex. 5 at 59, 62, 116.
• September 29, 2020. At 3:15 a.m., R3 went to the nurses’ station and asked for his PRN (as needed) medications. The nurse told him that she could not administer the drugs until 5:30 a.m. The resident became angry and threatened the nurse and the nurse aides. Although he walked away, he subsequently returned, again demanding the drugs. When staff denied his request, he walked off the unit and started throwing trays and flipping “skeleton” carts. He returned to the floor and threw “anything that was near him.” He smashed four computers and hit a staff member in the shoulder with a laptop. He threw coffee on her leg and an apple at her jaw. Security called the police, who handcuffed the resident until emergency medical services arrived and took him to the hospital for evaluation. CMS Ex. 5 at 115.
• October 5, 2020. R3 was yelling and cursing at a nurse, using racial slurs. CMS Ex. 5 at 112.
• October 6, 2020. R3 was cursing at a recreation aide who told him not to go into the pantry. CMS Ex. 5 at 111.
• October 9, 2020. R3 yelled at nurse aide, using racist slurs. CMS Ex. 5 at 106.
• October 18, 2020. At 4:30 a.m., R3 threw a tray, a box of tissues, a box of gloves, and a walkie/talkie at a nurse aide. He yelled, cursed, and threatened to kill the nurse aide. The facility called the police, who took him to the emergency room for evaluation. CMS Ex. 5 at 104.
• October 25, 2020. R3 “became agitated.” He cursed at nurses and threw his lunch tray into the trash can. CMS Ex. 5 at 102.
• November 4, 2020. R3 cursed at a nurse. CMS Ex. 5 at 101.
• November 15, 2020. The resident was “yelling [and] cursing at staff.” CMS Ex. 5 at 99.

A psychiatric progress note, dated November 23, 2020, reported that R3 exhibited paranoid ideation/delusions and possible auditory hallucinations. His attention was fair and he had poor-to-fair impulse control. CMS Ex. 5 at 197.

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On November 30, 2020, R3’s physician ordered visual 15-minute checks every shift “for safety.” CMS Ex. 5 at 10, 93. The instruction was added to his care plan that day and was to continue for five days. CMS Ex. 5 at 28, 93.

• December 1, 2020. Notwithstanding the November 30 physician order, R3 was in an “altercation” with another resident over cigarettes. He suffered scrapes to his left hand and left heel. CMS Ex. 5 at 58, 94, 181.
• December 2, 2020. R3 continued “to wander in and out of [the] unit.” CMS Ex. 5 at 93. He stepped off the elevator and told the nurse that he had fallen (which may have been untrue – see below) but was uninjured. Id.

On December 4, 2020, a social worker progress note describes R3 as “sad/depressed and expressionless.” His mood was depressed; his affect was flat; his responses were “lethargic”; his judgment and insight were fair. He lacked motivation. He reported that “a voice was telling him to call his mother.” He reported periods of not being able to control his anger but thought he was improving. He said that his symptoms of depression were increasing because of his lost independence. CMS Ex. 5 at 90-92.

R3, himself, seemed to recognize that his condition was deteriorating. A progress note, dated December 4, 2020, recounts that, after falsely telling a nurse that he had fallen, R3 apologized, explaining, “[M]y disease is progressing[,] and I can’t control myself.” CMS Ex. 5 at 58.

Progress notes for December 17 and 18, 2020 (the day before his accident), describe the resident’s symptoms of an upper respiratory infection. Notes also indicate that staff continued to supervise him closely. CMS Ex. 5 at 82.

Physician orders. On September 17, 2020, R3’s physician ordered: “RESIDENT IS ‘NOT’ ALLOWED OUT ON PASS. Resident may NOT sign himself in or out” of the facility. CMS Ex. 5 at 59, 121.

On October 12, 2020, the physician renewed the order, with the same emphasis: “RESIDENT IS ‘NOT’ ALLOWED OUT ON PASS. Resident may NOT sign himself in or out” of the facility. Id.

Although staff were obviously aware of the physician order, they took no meaningful steps to follow it. On more than one occasion before his accident, R3 left the facility unaccompanied. Yet, his care plan does not mention the order and includes no interventions aimed at addressing it. CMS Ex. 5 at 230 (indicating that no plan of care had been developed or interventions put in place to address the issue of R3 leaving the facility unaccompanied).

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• September 20, 2020. R3 left the building after staff told him that his physician ordered that he not leave the facility by himself. CMS Ex. 5 at 119.
• September 21, 2020. A cryptic progress note indicates that R3 left the building (possibly at 11:39 a.m., although the note is ambiguous). CMS Ex. 5 at 118.
• October 4, 2020. At about 9:20 a.m., after an altercation with staff, R3 left the facility by himself, telling staff that he was going to buy cigarettes. He returned at about 10:30 a.m. After he returned, staff told him that he was not allowed to leave the premises. CMS Ex. 5 at 113.

The elopement and accident. According to the facility’s investigation and report of the incident, on December 19, 2020, R3 left the facility at about 1:00 p.m. by way of the patio. A facility “smoking monitor” told him that he was not allowed to leave, but R3 left anyway. CMS Ex. 5 at 230, 232.

The smoking monitor later reported that he told the resident that he was not supposed to leave because of his physician order and because of the weather; it had snowed and was icy, which was particularly problematic for someone with impaired balance and coordination. CMS Ex. 5 at 239; CMS Ex. 6 at 61; see CMS Ex. 5 at 23, 24. According to the facility’s report to the state agency, the smoking monitor also claimed that he notified R3’s assigned nurse that the resident had left. CMS Ex. 5 at 232. I did not see any documentation of this, and, in his signed statement, the smoking monitor did not claim to have reported the departure. CMS Ex. 5 at 239. When he later told the surveyor that he had reported it to “the nurse,” he could not remember which nurse, and Petitioner has not identified that nurse. CMS Ex. 6 at 61. The question, however, is not material.

At 2:25 p.m. that day, the resident’s sister called the facility to report that R3 “had a fall outside the facility” and was in the emergency room. CMS Ex. 5 at 82.

The sister’s report was incomplete, but not inaccurate. As the police report clarifies, R3 was at an intersection that had no crosswalk. Although the light was red, he stepped off the curb and into oncoming traffic. He was hit by a car. CMS Ex. 5 at 238. He was sent to the hospital and found to have a fractured left wrist and a sprained left ankle. CMS Ex. 5 at 138, 140, 208.

The facility did not report the incident to the state agency until February 1, 2021. CMS Ex. 5 at 1. See 42 C.F.R. § 483.12(c) (requiring that the facility investigate all alleged violations involving neglect or mistreatment, including injuries of unknown origin, and to report the results of all investigations to the state survey agency within five working days of the incident); see Beverly Healthcare Lumberton v. Leavitt, 338 Fed. App’x 307, 314‑15 (4th Cir. 2009); Century Care of Crystal Coast, DAB No. 2076 at 25 (2007)

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(failing to investigate and report suggests a “wider systemic problem in the facility” that leaves its other residents “at real risk for serious harm.”); CMS Ex. 7 at 1.

Inadequate supervision. The undisputed evidence thus establishes that the facility was not in substantial compliance with section 483.25(d). Notwithstanding two physician orders and its own policies, the facility did not take reasonable steps to ensure that R3 left the facility only in an authorized manner. See Heritage Park Rehab. and Nursing Ctr., DAB No. 2231 at 10-11 n.8 (2009).

The facility enforced none of the procedures set forth in its “out-on-pass unaccompanied” policy. No one reviewed with R3 his responsibility to sign out. He did not sign a “Leaving Unaccompanied” form. He did not review the potential risks he could incur. No one documented his contact information. CMS Ex. 7 at 11.

Petitioner points to an out-on-pass form, dated September 24, 2020, and signed by R3 (although not by any staff member). CMS Ex. 5 at 223. Most of the form is left blank. This basically blank form does not comply with the policy instructions, which require that the resident sign in and out every time he leaves the facility. Nor does the form include the specific information and documentation required. See Green Valley Healthcare and Rehab. Ctr., DAB No. 2947 at 19 (2019) (holding that 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 the residents’ highest practicable physical, mental, and psychosocial well-being); North Las Vegas Care Ctr., DAB No. 2946 at 6 (2019); Hanover Hills Health Care Ctr., DAB No. 2507 at 6 (2013).

Petitioner, however, does not argue that facility staff adequately monitored R1’s whereabouts; it argues that they didn’t have to. Notwithstanding the resident’s diagnoses, assessments, behaviors, and physician orders, Petitioner points out that R3 had never been adjudicated incompetent and was fully capable of making his own decisions. P. Br. at 11. In Petitioner’s view, R3 had the right to make his own choices, including the right to leave the facility against medical advice. P. Br. at 3. Indeed, Petitioner accuses CMS of perpetuating the “stigma against individuals with mental illness.” P. Br. at 12.

A facility may not so easily disavow its obligation to keep safe a volatile and vulnerable resident who leaves the facility unaccompanied. It must “‘take steps to protect residents from harm when they temporarily [leave] the facility’ by being aware of the circumstances of a resident’s departure.” Venetian Gardens, DAB No. 2286 at 22 (2009), quoting Eastwood Convalescent Ctr., DAB No. 2088 (2007). The Departmental Appeals Board saw such an obligation as “consistent with the goal of the [quality-of-care] provisions.” DAB No. 2286 at 22.

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In Venetian Gardens, the Board also pointed out that a resident’s choice to leave a facility could be considered a refusal of the care and supervision that the facility might otherwise provide. Id. As with any situation in which a resident refuses care, the facility must ensure that the refusal is informed, attempt to address the cause of the refusal, and look for alternatives. This includes assessing the potential consequences of the refusal and reasonable alternatives that would not violate resident rights. Id.

The Board reiterated this position in Van Duyn Home and Hospital, DAB No. 2368 (2011), confirming that the facility must “fully assess” the particular risks of accidents and injuries a resident faces when leaving the facility, must plan and offer reasonable alternatives to minimize those risks, and must document that the resident, despite being informed of the risks, chose to refuse the care. Id at 10. The Board approved the notion that a facility should “impose ‘an escalating series of constraints and parameters’ to set safe conditions for resident absences.” Id. at 7.8 

Petitioner nevertheless suggests that the facility was not required to address potential risks because, notwithstanding his treatment records, R3 was not so impaired as to require it. To support this remarkable position, Petitioner must undermine its own records. Petitioner argues that R3’s diagnosis was improper; that certain assessments were invalid; and that staff’s disregard of the physician orders was justified. I find Petitioner’s legal position untenable and its evidence in support immaterial (or nonexistent).

Diagnosis. For the first time, Petitioner now questions whether R3 was properly diagnosed with Pick’s disease. P. Br. at 13. Petitioner submits the written declaration of Peter N. Fish, M.D., the facility’s medical director until August 2021 (shortly before R3 began to exhibit his more extreme and dangerous behaviors). P. Ex. 17 at 1 (Fish Decl. ¶ 1). Former Director Fish suggests that R3 did not have Pick’s disease. He argues that R3’s other diagnoses – traumatic brain injury, post-traumatic stress disorder, major depressive disorder with psychosis, obsessive-compulsive disorder, and personality disorders – could account for his extreme and problematic behaviors. P. Ex. 17 at 3 (Fish Decl. ¶ 10). He also asserts that hallucinations and gait instability are not components of Pick’s disease. P. Ex. 17 at 3 (Fish Decl. ¶ 11).

Whether R3’s behaviors were attributable to Pick’s disease or another of his diagnoses is not material. Based on his behavioral outbursts, not his diagnosis, his physician ordered that he not be allowed to leave the facility on a pass. CMS Ex. 5 at 59, 121. Further, the facility’s “out-on-pass unaccompanied” policy – which the facility did not follow --

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applied generally to all “competent” residents whose physicians had allowed them to leave the facility unaccompanied. CMS Ex. 7.

Assessments. Petitioner concedes that staff completed assessments on October 5 and December 20, 2020, that identified R3 as a wandering risk but, citing the opinion of Nurse Consultant Gail Rader, Petitioner questions the validity of the assessments. Petitioner suggests that the assessment tool (which it selected and was free to change) was inadequate. P. Br. at 15; P. Ex. 15 at 10 (Rader Decl. ¶ 28). This is an unusual and troublesome position for a facility to take and undermines any claim that it was in substantial compliance. An accurate assessment is critical to providing necessary care and services. Assessments are used to develop and revise the resident’s comprehensive plan of care. 42 C.F.R. §§ 483.20, 483.20(d), 483.21(b)(1). If the assessment is invalid, the plan of care and its interventions are invalid. That alone would put the facility out of substantial compliance with section 483.25(d), as well as sections 483.20 (resident assessments) and 483.21 (care planning).

Further, if I reject the notion that the assessments were invalid, Petitioner cannot prevail. There is no dispute that, notwithstanding his physician’s orders, R3 often left the facility while unsupervised. So, even if I agreed that the resident was free to leave the facility unaccompanied (which I do not), the facility was required to keep him safe when he did so. As I’ve discussed, the undisputed evidence establishes that it did not follow the policies it had in place to keep unaccompanied residents safe when they left the facility.

Disregard of physician order. As outlined above, the facility did not take seriously the physician’s orders. The September 17 and October 12 orders were definitive. Yet, staff added no interventions to R3’s care plan in order to address the resident’s proclivity for leaving unaccompanied.

The facility has attempted to justify its disregard for the physician’s order by claiming that the physician based his order on R3’s “frequent behavioral outbursts occurring at the time the order was written” and that his most recent behavioral outburst occurred on October 18, 2020. P. Br. at 9; CMS Ex. 5 at 232, 240. R3’s physician is not a witness and does not submit a written declaration. Instead, the record includes a written note from him, dated January 12, 2021. The physician acknowledges that he issued the September 17, 2020 order that R3 should not be allowed “out on a pass unescorted.” He writes that he issued the order because of R3’s behavioral outbursts “that were a common occurrence at that time[,] and he had multiple instances of going out on crisis.” The physician concludes with: “To my knowledge[,] he has not had a major behavioral outburst requiring him to go out to crisis since 10/18/20.” CMS Ex. 5 at 240.

The physician does not mention his October 12, 2020 order. He does not claim that he rescinded either order. He does not even opine that R3 could safely have left the facility unescorted at any time after he issued those orders.

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There are significant problems with Petitioner’s suggestion that staff were free to disregard the physician’s order. First, although staff may not have called the police, R3’s behavioral outbursts, some quite serious, continued through December. CMS Ex. 5 at 102 (describing an October 25 incident of R3 cursing and throwing his lunch tray into the trash); CMS Ex. 5 at 99, 101 (describing November 4 and 15 incidents of R3’s yelling and cursing at staff). In significant respects, his condition seemed to deteriorate. By November 23, his psychiatrist reported paranoid ideation and delusions, as well as possible auditory hallucinations. CMS Ex. 5 at 197. On November 30, his physician ordered 15-minute checks every shift “for safety.” CMS Ex. 5 at 10, 28, 93. Notwithstanding that order, the following day, R3 was in an altercation with another resident and was injured – suffering scrapes to his hand and heel. CMS Ex. 5 at 58, 94, 181. The resident himself admitted that his condition was deteriorating and that he could not control himself. CMS Ex. 5 at 58.

Second, on September 20, 2020 – just three days after the physician first issued the order to prevent R3 from leaving on a pass – the facility staff disregarded it. R3 left the building unaccompanied and, aside from telling him about the physician order, staff implemented no interventions to prevent his departure (there were none in his care plan). Similarly, staff again disregarded the order on October 4, 2020, just a few days after another outburst that had required police intervention. CMS Ex. 5 at 113, 115, 119.

Finally, the argument is irrelevant. Unless the physician rescinded his order – which he did not – staff were required to follow it. Failing to follow a physician order puts the facility out of substantial compliance with section 483.25. Cedar Lake Nursing Home, DAB No. 2390 at 3 (holding that a facility’s failure to comply with physician orders, a resident’s care plan, 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. Dept. of Health & Human Services, 239 F. App’x 80 (5th Cir. 2007) (citing Lakeridge Villa Health Care Ctr., DAB No. 988 at 22 (2005), aff’d, Lakeridge Villa Care Ctr. v. Leavitt, 202 F. App’x 903 (6th Cir. 2006)).

2. The undisputed evidence establishes that CMS’s determination that 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

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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 Ctr. – 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 Ctr., 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”).

Without citing any support, Petitioner argues that, in addition to its regulatory definition (noncompliance that has caused or is likely to cause serious injury, harm, impairment, or death to a resident), immediate jeopardy requires the noncompliance to create “a need for immediate corrective action” by the provider “to prevent serious injury, serious harm, serious impairment, or death from recurring.” P. Br. at 18.9 The Board has explicitly rejected this assertion, pointing out that it is not found in the regulatory definition of immediate jeopardy, 42 C.F.R. § 488.301, by which we are bound. Countryside Rehab. and Health Care, DAB No. 2853 at 25 (2018) (“The imminence of resident harm is not an element of the regulatory definition of immediate jeopardy”); Kindred, DAB No. 2792 at 20; 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 16.10 

The undisputed evidence establishes R3’s significant vulnerabilities. Even accepting that he did not have Pick’s disease, Petitioner concedes that he suffered from traumatic brain injury, post-traumatic stress disorder, major depressive disorder with psychosis, and other

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serious impairments. He abused drugs. He was exhibiting delusions and hallucinations. He repeatedly exhibited dangerous behavioral outbursts. Recognizing the dangers he posed to himself and others and his need for close supervision, his physician ordered that he not leave the facility unaccompanied. Determining that a facility’s failing to supervise such a vulnerable resident is likely to cause him serious injury is not clearly erroneous, particularly since he was seriously injured.

3. The undisputed evidence establishes that the CMPs imposed – $9,485 per day for 20 days of immediate jeopardy and $225 per day for 35 days of substantial noncompliance that did not pose immediate jeopardy – are 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 (2023); 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 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 (2016).

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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; Heritage Plaza Nursing Ctr., DAB No. 2017 at 22 (2017), quoting Oaks of Mid City Nursing and Rehab. Ctr., DAB No. 2375 at 26-27 (2011).

Here, Petitioner offers no evidence or argument except to claim no potential harm and to assert that the cited deficiencies should be deleted. P. Br. at 24.

Penalties are inflation-adjusted and change annually. The amount is determined as of the date the penalty is assessed, in this case, June 4, 2021. CMS Ex. 2; 85 Fed. Reg. 2,869, 2,880 (Jan. 17, 2020). Here, CMS imposed a per-day CMP of $9,485, which is at the low end of the range for situations of immediate jeopardy ($6,808 to $22,320). 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 ($112 to $6,695). 42 C.F.R. §§ 488.408(e), 488.438; 45 C.F.R. § 102.3; 87 Fed. Reg. 15,111-12 (Mar. 17, 2022).

CMS presents evidence showing that the facility had a less than stellar compliance history. Petitioner has a significant history of substantial noncompliance. In the surveys completed between December 2015 and January 2021, the facility was consistently found out of substantial compliance, with deficiencies cited at scope and severity levels D (isolated instance of substantial noncompliance that causes no actual harm with the potential for more than minimal harm), E (pattern of substantial noncompliance the causes no actual harm with the potential for more than minimal harm), F (widespread substantial noncompliance that causes no actual harm with the potential for more than minimal harm) and J (isolated instance of substantial noncompliance that poses immediate jeopardy to resident health and safety). CMS Ex. 3 at 1.

Petitioner does not claim that it is unable to pay the penalty.

Applying the remaining factors, I have discussed in some detail the facility’s significant failure to provide R3 with the supervision he needed to keep him safe. Despite his vulnerabilities and his physician’s explicit orders, facility staff failed to take any precautions to prevent him from leaving the facility unaccompanied. They did not even follow the basic procedures in place to ensure the safety of competent residents leaving the facility.

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CONCLUSION

For all of these reasons, I grant CMS’s motion for summary judgment. The undisputed evidence establishes that, from December 19, 2020, through February 11, 2021, the facility was not in substantial compliance with 42 C.F.R. § 483.25(d). From December 19, 2020, through January 7, 2021, its deficiencies posed immediate jeopardy to resident health and safety. The penalties imposed – $9,485 per day for 20 days of immediate jeopardy and $225 per day for 35 days of substantial noncompliance that did not pose immediate jeopardy – are reasonable.