Osage Healthcare & Wellness Centre, DAB CR6563 (2024)

DECISION

Resident 1, a resident at a skilled nursing facility (SNF) called Osage Healthcare & Wellness Centre (Petitioner or facility), left the facility alone and unnoticed during the day.  This occurred even though Resident 1 has right-side hemiplegia and propels her wheelchair backwards by pushing off with one foot.  Before Resident 1 left the facility, Resident 1 had a history of stroke/CVA, major depressive and bipolar disorders, attempted self-harm, diabetes, a myriad of other physical ailments, and was under a physician’s order not to leave the facility unaccompanied.  Resident 1 also needed medications to be administered each day, such as insulin.  After Resident 1 left, facility staff soon realized Resident 1’s absence and conducted a fruitless search.  A week later, Resident 1’s daughter found Resident 1 living outside, miles from the facility, and brought Resident 1 to the facility.  Petitioner refused to allow Resident 1 back in the facility, and Resident 1 was taken to a hospital.  The hospital concluded that Resident 1 had another stroke, extremely high blood pressure, and significantly elevated blood glucose levels.  Petitioner did not report Resident 1’s absence to the California Department of Public Health (state agency) until the day after Resident 1’s daughter found Resident 1.

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The state agency investigated the circumstances surrounding Resident 1’s absence on behalf of the Centers for Medicare & Medicaid Services (CMS).  The state agency found that Petitioner failed to substantially comply, at the immediate jeopardy level, with the Medicare requirement for SNFs to provide adequate supervision for residents to prevent accidents.  CMS imposed a remedial civil money penalty (CMP) on Petitioner.  Petitioner requested a hearing to dispute the state agency’s findings and the CMP.

For the reasons explained below, I conclude that:  Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(d); CMS’s determination that Petitioner immediately jeopardized the health and safety of residents is not clearly erroneous; and the amount and duration of the remedial per-day CMP is appropriate and reasonable.

I.     Legal Framework

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

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

A participating SNF must meet a variety of ongoing statutory requirements regarding how it provides services, maintains the rights of its residents, and administers its facility.  42 U.S.C. § 1395i-3(a)(3), (b)-(d).  Further, SNFs must comply with “such other requirements relating to the health, safety, and well-being of residents or relating to the physical facilities thereof as the Secretary may find necessary.”  42 U.S.C. § 1395i-3(d)(4)(B); see 42 U.S.C. § 1395i-3(c)(1)(xi), (f).  The Secretary has promulgated regulations to establish those additional requirements.  See 42 C.F.R. pt. 483, subpt. B.1

When an SNF fails to meet a statutory or regulatory participation requirement, then the SNF has a “deficiency.”  42 C.F.R. § 488.301; see 42 U.S.C. § 1395i-3(h)(1).  “Noncompliance” means “any deficiency that causes a facility to not be in substantial compliance.”  42 C.F.R. § 488.301; see also 42 U.S.C. § 1395i-3(h)(3).  To maintain

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“substantial compliance,” an SNF’s deficiencies may “pose no greater risk to resident health or safety than the potential for causing minimal harm.”  42 C.F.R. § 488.301.

“It is the duty and responsibility of the Secretary to assure that requirements which govern the provision of care in skilled nursing facilities . . . are adequate to protect the health, safety, welfare, and rights of residents and to promote the effective and efficient use of public monies.”  42 U.S.C. § 1395i-3(f)(1).  To do so, the Secretary contracts with state agencies to conduct surveys to determine whether SNFs are in substantial compliance.  42 U.S.C. §§ 1395aa(a), 1395i-3(g); 42 C.F.R. § 488.10.  Standard surveys are unannounced and occur at least once every 15 months.  42 U.S.C. § 1395i-3(g)(2)(A)(i), (iii)(I).  State agencies also conduct investigations into complaints against SNFs.  42 U.S.C. § 1395i-3(g)(1)(C), (4).

When the results of a survey show that an SNF is not in substantial compliance with program participation requirements, the Secretary may impose enforcement remedies on the SNF.  42 U.S.C. § 1395i-3(h)(2); 42 C.F.R. § 488.406.  All enforcement remedies imposed on SNFs are remedial in nature because they “ensure prompt compliance with [Medicare] program requirements” and “are applied on the basis of noncompliance found during surveys conducted by CMS or by the survey agency.”  42 C.F.R. § 488.402(a)-(b); see 42 U.S.C. §§ 1395i-3(h)(2)(B) (indicating imposition of enforcement remedies while skilled nursing facilities are out of compliance with health and safety requirements until compliance is resumed).  To assist in a quick return to substantial compliance, SNFs must file a plan of correction with the state agency/CMS.  42 C.F.R. § 488.402(d).

When CMS selects an enforcement remedy to impose on an SNF, it determines the scope (i.e., the number of residents affected or potentially affected) and severity (i.e., the degree of harm or potential harm) for each deficiency.  See 42 C.F.R. § 488.404(a)-(b).  The highest level of severity occurs when the noncompliance immediately jeopardizes the health or safety of SNF residents.  See 42 U.S.C. § 1395i-3(h)(1).  “Immediate jeopardy” exists when “the provider’s noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident.”  42 C.F.R. § 488.301.

One enforcement remedy is a CMP.  42 U.S.C. § 1395i-3(h)(2)(B)(ii).  CMS may impose a remedial per-day CMP for the number of days an SNF is not in substantial compliance.  42 U.S.C. § 1395i‑3(h)(2)(A), (h)(2)(B)(ii)(I); 42 C.F.R. § 488.430(a).  For CMPs assessed on or after January 17, 2020, and for deficiencies that occurred after November 2, 2015, the CMP amounts may range as follows:  $112 to $6,659 per day for less serious noncompliance; or $6,808 to $22,320 per day for more serious noncompliance that poses immediate jeopardy to the health and safety of residents.  45 C.F.R. § 102.3 (2020); 85 Fed. Reg. 2869, 2870, 2880 (Jan. 17, 2020); see 42 C.F.R. § 488.438(a)(1) (providing original CMP amounts before statutory inflation adjustments).

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If CMS imposes a CMP based on a finding of noncompliance, then the SNF may request a hearing before an administrative law judge (ALJ) to challenge CMS’s initial determination of noncompliance that led to the imposition of an enforcement remedy and/or the level of noncompliance if a successful challenge to the level would affect the range of CMP amounts imposed on the SNF.  42 U.S.C. §§ 1320a-7a(c)(2), 1395i‑3(h)(2)(B)(ii); 42 C.F.R. §§ 488.330(e)(3)(ii), 488.408(g)(1), 488.434(a)(2)(viii), 498.3(b)(13)-(14), (d)(10); see also 5 U.S.C. §§ 554, 556.  However, CMS’s choice of remedies is not reviewable.  42 C.F.R. §§ 488.438(e)(2), 488.408(g)(2), 498.3(b)(13).

If an SNF challenges the existence of a deficiency, CMS must make a prima facie case that the SNF failed to substantially comply with federal participation requirements and, if such a showing is made, the SNF must then prove substantial compliance by a preponderance of the evidence.  Hillman Rehab. Ctr., DAB No. 1611 at 8 (1997); see Batavia Nursing & Convalescent Inn, DAB No. 1911 (2004); Batavia Nursing & Convalescent Ctr., DAB No. 1904 (2004), aff’d, Batavia Nursing & Convalescent Ctr. v. Thompson, 129 F. App’x 181 (6th Cir. 2005); Emerald Oaks, DAB No. 1800 (2001).  If an SNF challenges CMS’s determination as to the level of noncompliance, CMS’s determination must be upheld unless it is clearly erroneous.  42 C.F.R. § 498.60(c)(2).

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

The SNF or CMS may administratively appeal an ALJ’s decision.  42 C.F.R. § 498.80.

II.    Background

Petitioner is an SNF located in Inglewood, California.  On March 16, 2021, a state agency surveyor commenced an investigation into a complaint involving Resident 1.  CMS Ex. 13 ¶ 7.  On April 13, 2021, the state agency completed the investigative survey.  CMS Ex. 1 at 1; CMS Ex. 13 ¶ 3.  The state agency found the following deficiency and documented it in a Statement of Deficiencies (SOD):

• 42 C.F.R. § 483.25(d)(1), (2) (F-Tag 689 (S/S = J) (Free of Accident Hazards/Supervision/Devices)).

CMS Ex. 1 at 1-2.  The state agency informed Petitioner, on March 18, 2021, that this deficiency immediately jeopardized the health and safety of residents.  CMS Ex. 1 at 1.  On March 19, 2021, Petitioner abated the immediate jeopardy situation when it filed an acceptable plan of action for correction of the immediate jeopardy with the state agency.  CMS Ex. 1 at 1-2.

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On April 22, 2021, Petitioner filed a plan of correction with the state agency in order to achieve substantial compliance with 42 C.F.R. § 483.25(d).  CMS Ex. 8.  On May 13, 2021, the state agency conducted a re-visit survey and found that Petitioner had returned to substantial compliance.  P. Ex. 1; P. Ex. 9 ¶ 25; CMS Ex. 13 ¶ 3.

Based on the findings in the SOD, on August 31, 2021, CMS issued a notice of initial determination in which CMS imposed the following remedial CMPs on Petitioner: 

• $7,460 per-day CMP for 2 days (March 18-19, 2021), totaling $14,920.
• $225 per-day CMP for 54 days (March 20-May 12, 2021), totaling $12,150.

CMS Ex. 2 at 2.

On October 29, 2021, Petitioner requested a hearing to dispute the SOD’s findings and the imposition of a CMP.  Also on October 29, 2021, the Civil Remedies Division acknowledged receipt of the hearing request and issued my Standing Prehearing Order (SPO), which provided the parties with deadlines for submitting prehearing exchanges.

In accord with the SPO, CMS filed a prehearing brief and 14 proposed exhibits, including the investigating nurse surveyor’s written direct testimony.2  CMS Ex. 13.  Petitioner then filed a prehearing brief and nine proposed exhibits, including the facility Administrator’s written direct testimony.3  P. Ex. 9.  Each party requested to cross-examine the opposing party’s witness.  Each party objected to some of the proposed exhibits.

On November 28, 2022, I notified the parties that I would hold a hearing on February 28, 2023, to allow the parties to cross-examine the witnesses in this case.  In the Notice of Hearing, I admitted CMS Exhibits 1 through 8 and 10 through 14 and Petitioner’s Exhibits 1 through 6, 7 (page 1 only), 8, and 9 into the record.  I noted that I had provisionally admitted the witness declarations (CMS Ex. 13; P. Ex. 9) pending cross-examination, after which I would deem them fully admitted into the record.

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On February 28, 2023, I held a hearing at which the parties cross-examined the witnesses in this case.  At the end of the hearing, I discussed the schedule for post-hearing briefing and the requirement that the parties present, in their post-hearing briefs, all of their arguments without cross-referencing earlier briefs.  Tr. 105-08; see May 3, 2023 Notice of Receipt of Transcript and Post-Hearing Briefing Schedule.

From June through August 2023, CMS and Petitioner filed post-hearing briefs (CMS Br. and P. Br., respectively) and CMS filed a reply brief (CMS Reply).

III.    Issues

1) Whether Petitioner was in substantial compliance with 42 C.F.R. § 483.25(d).

2) If Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(d), whether CMS’s determination that Petitioner immediately jeopardized the health and safety of its residents is clearly erroneous.

3) If Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(d), whether a per-day CMP of $7,460 for 2 days and a per-day CMP of $225 for 54 days are appropriate and reasonable under the statute and regulations.

IV.    Findings of Fact and Conclusions of Law (FFCL), and Analysis

1. In early 2021, Resident 1 was a 50-year-old woman with a history of major depressive and bipolar disorders, attempt to self-harm, epileptic seizure disorder, stroke, hypertension, and diabetes.  Resident 1 was taking daily medications to manage her seizures, diabetes, depression, and to prevent future strokes.  She was wheelchair bound with impaired mobility, including right-sided hemiparesis or hemiplegia.  Resident 1 was noted to be at risk for falls due to her limited mobility, poor balance, decreased endurance, unsteady gait, history of falls, right-sided hemiparesis or hemiplegia, seizure disorder, and her tendency to forget to call or wait for assistance.  She had a physician order permitting her to leave the facility on pass if accompanied by a responsible party or person.  Resident 1 was assessed not to be an elopement risk; however, her diagnoses for depression and bipolar disorder were noted as increasing her elopement risk.

At the time of her initial admission to the facility in January 2019, Resident 1 was a 50‑year-old woman with a history of major depressive and bipolar disorders, attempt to self‑harm, epileptic seizure disorder, stroke, hypertension, and diabetes.  CMS Ex. 4 at 1‑3.  Resident 1’s admitting diagnoses included reduced mobility, abnormalities of gait and mobility, limitations of activities due to disability, dysphagia, hemiplegia following cerebral infarction, Type 2 diabetes, hypertension, bipolar disorder, major depressive

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disorder, and muscle weakness.  CMS Ex. 4 at 3.  Resident 1 was her own “Responsible Party.”  CMS Ex. 4 at 2.

A June 23, 2020 physical examination showed that Resident 1 was wheelchair bound and had the capacity to understand and make decisions, but also indicated a history of depression, an attempt to harm herself, seizure, and stroke (CVA).  CMS Ex. 4 at 1.  The diagnoses included CVA with hemiparesis, seizure disorder, diabetes, and impaired mobility.  CMS Ex. 4 at 1.

An August 4, 2020 physician order states that Resident 1 could leave the facility on pass if she was accompanied by a responsible party or person.  CMS Ex. 4 at 6.

A January 20, 2021 Activity Assessment indicated that it was very important for Resident 1 to have control over a variety of matters in her life.  It also stated that she preferred reading, doing things with groups, participating in religious services, listening to music, keeping up with the news, and going outside in good weather.  P. Ex. 8.

On January 22, 2021, facility staff conducted the following assessments of Resident 1: 

• A Morse Fall Risk Assessment concluded that “Resident is High Risk.  Implement high risk fall prevention interventions.”  CMS Ex. 4 at 18.
• A Minimum Data Set (MDS) assessment indicated Resident 1 had a Brief Interview for Mental Status (BIMS) score of 13 out of 15 possible points, indicating that she met the threshold to be considered cognitively intact.  CMS Ex. 4 at 7; see also Tr. 19.  The MDS stated that there was no evidence of acute mental change, inattention, disorganized thinking or altered consciousness.  CMS Ex. 4 at 8.  Further, Resident 1 did not have any hallucinations or delusions and she did not exhibit any wandering behaviors.  CMS Ex. 4 at 9.  The MDS indicated that Resident 1 did not walk but that she used a wheelchair and needed supervision to locomote in the wheelchair.  CMS Ex. 4 at 11-12.  Resident 1 needed limited assistance when transferring between surfaces, for dressing, and toilet use, and Resident 1 was impaired in her upper and lower extremities on one side of her body.  CMS Ex. 4 at 10, 12.
• An Elopement Risk Assessment for Resident 1 stated that she:  did not display cognitive deficits or disorientation; had not left the facility without informing staff; had not stated that she wished to go home or packed her belongings; and did not have a pattern of wandering through the facility.  The assessment indicated that Resident 1’s diagnoses for depression and bipolar disorder increased her elopement risk.  Staff concluded that Resident 1 was not at risk for elopement at that time.  P. Ex. 5 at 3.

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On January 22, 2021, Petitioner updated Resident 1’s care plan as follows: 

• “Resident at risk for fall.”  CMS Ex. 4 at 15.  This entry noted that Resident had limited mobility, poor balance, decreased endurance, unsteady gait, forgets to call or wait for assistance, has a history of falls, and was diagnosed with seizure disorder and CVA with right-sided hemiplegia.  CMS Ex. 4 at 15.  Petitioner indicated that it would provide an environment that minimizes complications associated with falls along with several other specific ways to reduce fall risks, including encouraging Resident 1 to use a wheelchair.  CMS Ex. 4 at 15.
• “Impaired physical mobility and loss of balance and coordination secondary to diagnosis of CVA and right hemiplegia.”  CMS Ex. 4 at 14.
• “Language Barrier.”  CMS Ex. 4 at 17.  Resident 1 primarily spoke Spanish and, as a result, she was noted to have a risk of having difficulty making her needs known.  CMS Ex. 4 at 17.

A February 3, 2021 physician progress note, signed by a nurse practitioner, stated that Resident 1 was “[a]wake, alert, oriented x2, verbally responsive.”  P. Ex. 6.  The assessment included diagnoses of bipolar disorder, depression, dysphagia, impaired mobility, and long-term use of insulin.  P. Ex. 6.

In March 2021, Resident 1 was taking Depakote Sodium twice per day for seizures, Glipizide and Basaglar daily for diabetes, Lexapro daily for depression, and Aspirin daily to prevent CVA.  CMS Ex. 4 at 4-5.  Resident 1 needed insulin injections before meals and at bedtime.  CMS Ex 4 at 5; CMS Ex. 13 ¶ 7.

2. In 2020, Resident 1’s physician ordered that Resident 1 could be allowed out of the facility on a pass so long as a responsible party accompanied her.  Petitioner’s policy to reduce resident elopements from the facility stated that the facility needed a method for residents to sign out when leaving and a non-intrusive system to alert staff when residents were exiting the building.  In March 2021, Petitioner’s system to sign out when leaving the facility relied on each resident’s voluntary compliance.  Further, Petitioner neither assigned staff to monitor who was leaving the facility nor had a non-intrusive alarm system to alert staff to a resident exiting the facility.  Therefore, Petitioner did not effectively implement its policy and did not have a system in place to ensure implementation of Resident 1’s physician order requiring that Resident 1 leave only on pass with a responsible party.

On August 4, 2020, Resident 1’s physician issued an order permitting Resident 1 to leave the facility on pass if a responsible party accompanied her.  CMS Ex. 4 at 6.  As stated

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above, Resident 1 had significant mobility limitations and needed important medications on a daily basis for her serious chronic comorbidities.

Petitioner’s policy to reduce the risk of resident elopement stated that Petitioner should have “a resident sign-in/sign-out policy,” and “[i]nstall non-intrusive alarm systems that alert staff to resident exiting.”  CMS Ex. 7 at 6-7.  Despite this, in March 2021, Petitioner did not effectively implement this policy.

Petitioner’s Administrator agreed during questioning at the hearing that the facility had “an out-on-pass policy” in which “residents have to sign out when leaving the facility.”  Tr. 73; see also P. Ex. 9 ¶ 12.  However, when asked about implementation of the policy, the Administrator testified that the facility only “encouraged residents” to sign-out when leaving the facility, despite acknowledging that “you have to have a doctor’s order for out-on-pass.”  Tr. 73.  The Administrator further explained that facility nurses implement the “out-on-pass” policy because “[t]here is no receptionist area at the facility.”  Tr. 74.  As to whether the facility had an “out-on-pass” book for residents to sign, the Administrator testified:  “There should be, yes.”  Tr. 73.  Despite affirming that there should be an “out-on-pass” book for residents to sign, the Administrator was not certain where it was located, guessing that “[i]t [is] most likely at the nurses’ station.”  Tr. 74.

When asked if the nurses at the nurses’ station were monitoring the front door of the facility, the Administrator asked with uncertainty:  “What do you mean by monitoring?”  Tr. 74.  In terms of individuals entering, the Administrator testified that “no one can enter the facility. . . . You can leave the facility, but to come into the facility, you either have to ring the doorbell or knock on the door.”  Tr. 74.  Leaving the facility was far easier:  “There is a push button, and you press, and you leave the facility.”  Tr. 74.  When questioned as to how facility staff might know that a resident was leaving the facility, other than after a resident voluntarily arranges to sign-out, the Administrator did not know:  “I mean, we do a round at the facility.  You know, the staff work in the facility.  We know where patients are, and it’s kind of vague if someone wants to leave.”  Tr. 76.

The Administrator ultimately testified that, before March 2021, “no one monitored the door [of the facility].”  Tr. 77.  Further, the Administrator testified that when one pushed the button on the facility door to leave, “a small buzzer” sounded, but this was not an alarm system.  Tr. 78, 97, 100; see also CMS Ex. 13 ¶ 15.  The buzzer was loud enough to be heard beyond the immediate area of the doorway, and the Administrator thought that staff might check to see who was leaving, but “the function of the buzzer was not for that,” but simply functioned to indicate “[t]hat the door was opened.”  Tr. 97, 100.  In addition, the facility did not have any surveillance cameras at the main door to the facility.  CMS Ex. 13 ¶ 15.

CMS’s witness, the nurse surveyor, testified that Petitioner “had failed to take commonly used measures to prevent residents from eloping and failed to adequately supervise

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Resident 1.”  CMS Ex. 13 ¶ 18.  The nurse surveyor further testified that there are various precautions that a facility may implement to ensure adequate supervision:  1) assigning staff to monitor doors; 2) assigning staff to monitor areas where residents congregate, particularly if they are near doors; 3) requiring all guests and residents to sign in and out of the building when entering and exiting; 4) having locks and/or gates to prevent use of unmonitored doors; 5) making frequent visual checks of residents; 6) having door alarms; and/or 7) having surveillance cameras to assist with monitoring.  CMS Ex. 13 ¶ 18; Tr. 48.  The nurse surveyor also testified that these measures should be implemented for all residents in the facility and not just for ones assessed as elopement risks.  Tr. 48.

Therefore, Petitioner did not fully implement its policy to establish an effective sign-out system for residents or to install a non-intrusive system to alert staff when residents left the facility.  This meant that Petitioner could not implement the physician order allowing Resident 1 out of the facility on pass with a responsible party.4

3. Petitioner monitored Resident 1 for feelings of hopelessness and helplessness.  Between March 1 and March 5, 2021, facility staff noted that Resident 1 experienced 21 instances of feeling hopeless and/or helpless.

Starting on August 4, 2020, Petitioner administered Lexapro to Resident 1 each day for depression and “persistent feelings of hopelessness/helplessness.”  CMS Ex. 4 at 5.  Facility staff monitored Resident 1 every shift for feelings of hopelessness and helplessness.  CMS Ex. 4 at 19.  Between March 1 and March 5, 2021, Resident 1 experienced 21 instances of feeling hopeless and/or helpless.  CMS Ex. 4 at 19.

4. On March 6, 2021 at 4:30 p.m., Resident 1 propelled herself backward in her wheelchair toward her room at the facility after attending at a bingo game.  At 5:00 p.m., a facility staff member noticed that Resident 1 was missing when the staff member attempted to deliver dinner to Resident 1 in her room.  A search showed that Resident 1 was not in the facility.  Staff notified Resident 1’s daughter and the local police that Resident 1 had left the facility.  Staff searched for Resident 1 in the community and did not find her.

On March 6, 2021, at 4:30 p.m., facility staff saw Resident 1 propelling herself backward in a wheelchair toward her room after attending a bingo game.  At 5:00 p.m., when a dinner tray was delivered to Resident 1’s room, Resident 1 was not present.  A facility

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staff member looked for Resident 1 and, when Resident 1 could not be found, told the Charge Nurse of Resident 1’s absence.  CMS Ex. 5 at 1; P. Ex. 2 at 1, 3-4; P. Ex. 3.

After learning of Resident 1’s absence, the Charge Nurse instructed all nurses to search the facility and then search outside the facility on foot and by car.  At 6:15 p.m., facility staff called Resident 1’s daughter to determine if she had taken Resident 1 out of the facility.  Resident 1’s daughter denied doing so.  Staff also called local hospitals and then the local police department.  CMS Ex. 5 at 1-2; P. Ex. 2 at 1, 3-4; P. Ex. 3; P. Ex. 7 at 1.

At 7:20 p.m., police officers arrived, and the facility provided information about Resident 1 as well as her picture.  Staff told the officers that Resident 1 had the capacity to understand and make decisions, and the ability to verbally make her needs known.  In the evening the facility sent employees to search in the community for Resident 1 but they did not find her.  CMS Ex. 5 at 2; P. Ex. 2 at 4.

5. After Resident 1 left the facility on March 6, 2021, an unknown individual pushed Resident 1 in her wheelchair to a bus stop and gave Resident 1 some money.  Resident 1 took the bus to downtown Los Angeles and slept sitting in her wheelchair near a bus stop.  People occasionally gave Resident 1 food.  Resident 1 began to feel ill after a while.

According to Resident 1, after leaving the facility on March 6, 2021, an unnamed man assisted Resident 1 to a bus stop and gave her five dollars.  Resident 1 took a bus to downtown Los Angeles.  Once there, she slept near a bus stop in her wheelchair sitting up.  People gave Resident 1 some food to eat.  Resident 1 did not have her medications and started feeling ill while away from the facility.  CMS Ex. 13 ¶ 14.

6. On March 13, 2021, a week after Resident 1 left the facility, Resident 1’s daughter found Resident 1 in downtown Los Angles and took her to the facility.  Facility staff would not readmit Resident 1 and suggested that Resident 1 go to a hospital.

On March 13, 2021, Resident 1’s daughter found Resident 1 in downtown Los Angles and brought her back to the facility.  Facility staff refused to readmit Resident 1 and stated that Resident 1 should go to the hospital.  CMS Ex. 5 at 4-5; CMS Ex. 13 ¶ 12.

Facility staff completed a Discharge Against Medical Advice Form on March 13, 2021, at 2:45 p.m. and indicated that Resident 1 “refused to sign.”  CMS Ex. 5 at 6.  However, when Resident 1 was returned to the facility on March 13, 2021 at approximately 3:00 p.m. with her daughter, Petitioner’s Administrator refused to permit Resident 1 to return to the facility because “there is no admitting physician order. . . .”  CMS Ex. 5 at 4, 13.

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7. On March 13, 2021, Resident 1 went to a hospital emergency department (ED).  The ED staff determined that Resident 1 had a new CVA, significantly elevated blood pressure, and a high blood glucose level.  Petitioner was admitted to the hospital and remained there for six days.

On March 13, 2021, Resident 1 went to a hospital ED by ambulance.  CMS Ex. 6 at 1.  The ED noted a “language barrier” when examining her and acknowledged that Resident 1 had a prior CVA.  CMS Ex. 6 at 1.

Because the ED noted Resident 1 had “altered mental status,” they performed a computer tomography (CT) scan that showed Resident 1 had a new CVA on the left frontal lobe (acute-subacute large infarct) and also a “[s]uperimposed old lacunar infarct” on the left frontal lobe.  CMS Ex. 6 at 4-5, 8-9; CMS Ex. 13 ¶ 13.

Testing at the ED also showed that Resident 1 had significantly elevated blood pressure (214/82) and a high blood glucose level (208 with a reference range of 70-105).  CMS Ex. 6 at 1-3, 7; CMS Ex. 13 ¶ 13.

Resident 1 was admitted to the hospital’s telemetry unit for six days.  CMS Ex. 13 ¶ 13.

8. On March 14, 2021, Petitioner notified the state agency that Resident 1 left the facility without notifying staff.  Petitioner stated that Resident 1 had the capacity to make decisions and is self-responsible.  Petitioner did not state that Resident 1 had significant mobility limitations, was highly prone to falls, and needed daily medications to control her serious medical conditions.

In a March 14, 2021 letter, Petitioner’s Administrator informed the state agency that Resident 1 left the facility on March 6, 2021, without notifying the facility.  The letter stated that Resident 1 “has capacity to make decisions; she is self-responsible and her BIMS score is 13.”  Petitioner did not inform the state agency that Resident 1 lived outside for a week, had significant mobility limitations, was a fall risk, and had been without necessary medications while away.  Petitioner also did not state that Petitioner refused Resident 1 readmission when requested on March 13, 2021.  CMS Ex. 5 at 8.

9. Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(d) because Petitioner did not provide adequate supervision to ensure that a highly vulnerable resident did not leave the facility alone.  The lack of supervision placed Resident 1 at significant risk of harm through accident and resulted in injury due to a lack of medicines.  It was foreseeable that Resident 1 would be at significant risk of harm if Resident 1 left the facility alone because Resident 1’s physician ordered that Resident 1 only be allowed out of the facility on pass with a responsible party.  It was foreseeable that, based on Resident 1’s impaired mobility and need for daily medications,

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Resident 1 would be at grave risk of harm should she leave the facility alone.  It was also foreseeable that Resident 1 may leave the facility unaccompanied and without notice because staff assessed Resident 1 as having an increased elopement risk factor based on her diagnoses for major depressive and bi-polar disorders.  For five days leading to Resident 1’s departure from the facility on March 6, 2021, facility staff noted that Resident 1 said 21 times that she felt hopeless and helpless.  Therefore, it was foreseeable Resident 1 might leave the facility without notice given her mental state.  Further, Petitioner did not monitor who left the facility.  Petitioner knew that it needed a method of monitoring whether residents left the facility because it had a policy to that effect, but Petitioner failed to implement its policy to have a mandatory sign-out/sign-in system for residents and to install an alarm system to warn staff when a resident was leaving the facility.  On March 6, 2021, Resident 1 left the facility by propelling herself backwards in her wheelchair with one foot.  She left unnoticed, without a pass and without a responsible party.  Resident 1 lived homeless for a week until Resident 1’s daughter found her.  Resident 1 did not have her medications, resulting in significantly high blood pressure, a high blood glucose level, and a second CVA.  Because Petitioner failed to implement its policies, it also could not implement the physician order that Resident 1 only leave on pass with a responsible party.  Therefore, Petitioner was noncompliant with the requirement that it adequately supervise residents to prevent accidents.

The Social Security Act requires SNFs to “care for its residents in such a manner and in such an environment as will promote maintenance or enhancement of the quality of life of each resident” and “provide services to attain or maintain the highest practicable physical, mental, and psychosocial well-being of each resident, in accordance with a written plan of care.”  42 U.S.C. § 1395i-3(b)(1)(A), (2).  To properly enforce the statute, the Secretary promulgated the “quality of care” regulation at 42 C.F.R. § 483.25, which requires SNFs to ensure the following: 

(1) The resident environment remains as free of accident hazards as is possible; and 
(2) Each resident receives adequate supervision and assistance devices to prevent accidents.

42 C.F.R. § 483.25(d).5

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Petitioner does not dispute that Resident 1 left the facility alone on March 6, 2021, or that facility staff were unaware that she left.  Petitioner’s main argument is that it complied with 42 C.F.R. § 483.25(d) because Resident 1’s elopement “was wholly unforeseeable” because Resident 1 was: 1) never assessed as an elopement risk; 2) never displayed any behavior indicating she would elope; and 3) never verbalized an intent to leave the facility.  P. Br. at 1-2.  Rather, Petitioner asserts that “Resident 1 exercised her right to refuse care and treatment and left the facility of her own volition, which she had the right to do as a competent individual and her own legal decision-maker.”  P. Br. at 2.  Because Resident 1’s elopement risk was unknown and unforeseeable, Petitioner argues no interventions were required.  P. Br. at 19-20.

Petitioner points out that the nurse surveyor testified that Resident 1 was her own responsible party, she left the facility of her own volition, and she expressed her right to refuse treatment.  P. Br. at 5-6 (citing Tr. 19-21).  Because Resident 1 has the legal right to leave against medical advice, Petitioner argues that the facility is not responsible for what happened to Resident 1 after she left.  P. Br. at 5-6.  Petitioner asserts that the nurse surveyor could not articulate how it was foreseeable that Resident 1 was an elopement risk.  P. Br. at 6.  Petitioner also argues that it properly assessed Resident 1 for the risk of elopement and found none.  P. Br. at 14.  In addition, Petitioner asserts that “Resident 1 was able to protect herself because she was assessed as having good cognition, communication, memory, and was a competent decisionmaker.”  P. Br. at 15.

The facts discussed in FFCL 1 that support Petitioner’s position are: 

• The January 2021 elopement risk assessment showed a finding of no risk for elopement.
• Resident 1 was considered to be her own responsible person (i.e., sufficiently cognitively intact to make her own decisions), receiving a BIMS score of 13 in the January 2021 MDS.
• The January 2021 MDS assessed Resident 1’s mood as good.
• The January 2021 Activities Assessment showed Resident 1 was interested in activities.

Despite this evidence, the record provides many reasons that it was foreseeable that Resident 1 may leave the facility without assistance, especially given that, as explained in FFCL 2, Petitioner did not monitor who left the facility through the front door.  It was also foreseeable that, should Resident 1 leave without assistance through the unmonitored front door, Resident 1 was highly likely to be subject to significant harm due to a lack of mobility and Resident 1’s fragile medical condition that required medications and monitoring.  The facts in the record, as explained in FFCL 1 and 3, which support the position that it was foreseeable that Resident 1 might leave the facility alone and be at significant risk for harm are as follows:

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• Resident 1 was diagnosed with major depressive disorder.
• Resident 1 was diagnosed with Bi-polar disorder.
• Resident 1 had a history of seeking to harm herself.
• Resident 1 expressed 21 times between March 1 and 5, 2021, that she was feeling hopeless and/or helpless.
• A February 2021 mental status examination indicated Resident 1 was only alert and oriented x 2 (with x 4 being the highest).
• Resident 1’s physician ordered that Resident 1 could only leave the facility on pass from the facility when accompanied by a responsible party.
• Resident 1 had several medical conditions (e.g., epilepsy, diabetes, depression) requiring daily medications.
• Resident 1 had right side hemiplegia making independent movement outside the facility limited and unsafe.

As argued by Petitioner, it is true that the elopement of a resident from an SNF must have been foreseeable for the elopement to be the basis for a deficiency under section 483.25(d).  See Heritage Park Rehabilitation and Nursing Center, DAB No. 2231 at 9 (2009).  However, section 483.25(d) requires SNFs to provide adequate supervision of residents to prevent accidents.  Therefore, the SNF’s duty under section 483.25(d) is far broader than merely attempting to prevent foreseeable elopements.  See Glenoaks Nursing Ctr., DAB No. 2522 at 8 (2013) (citing cases that held that an SNF must take all reasonable steps to ensure that a resident receives supervision and assistance devices that meets assessed needs and to mitigate foreseeable risks of harm from accidents).  This means that an unforeseen elopement does not foreclose a section 483.25(d) deficiency if the SNF otherwise failed in its duty to provide adequate supervision to prevent other foreseeable accidents connected to the elopement.

In Kenton Healthcare, LLC, a section 483.25(d) deficiency was upheld even though the resident’s elopement was not foreseeable because “staff was on notice that Resident 11 required close supervision while ambulating and that had she received this supervision, she should not have been able to leave the building and walk down a busy street . . . undetected by staff.”  DAB No. 2186 at 7 (2008).  Likewise, in the present case, Petitioner’s staff knew that Resident 1 was assessed as a high risk for falls, which required preventative interventions.  CMS Ex. 4 at 18.  Further, while Resident 1 used a wheelchair to move within the facility, Resident 1 propelled it by pushing the wheelchair backwards using one foot.  CMS Ex. 5 at 1; P. Ex. 2 at 4; P. Ex. 3 at 1-2.  This method of moving the wheelchair relates to Resident 1’s diagnosed history of CVA and right-side hemiplegia.  CMS Ex. 13 ¶ 7; see also CMS Ex. 4 at 12, 14 (Resident 1 assessed as being impaired on one side for both the upper and lower extremities).  Unsurprisingly, the January 2021 MDS assessment stated that Resident 1 needed “Supervision - oversight” when locomoting in the wheelchair.  CMS Ex. 4 at 10-12.  Despite the obvious risk posed to Resident 1, either walking unaided or propelling herself backwards in a wheelchair, the

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record does not show that Petitioner’s staff supervised Resident 1’s movements, allowing Resident 1 an opportunity to leave the facility alone.

Petitioner’s obligation to foresee potential accidents for Resident 1, if Resident 1 was left alone, is plainly seen in the physician order that Resident 1 should only be allowed out of the facility on a pass when accompanied by a responsible party.  CMS Ex. 4 at 6.  A physician-issued pass order “may well serve as a useful record of competency and medical ability to leave, but obtaining such a pass does not exhaust the facility’s responsibility to evaluate foreseeable risks and offer appropriate interventions to mitigate them, whether or not the residents choose to accept the offer of care.”  Van Duyn Home & Hosp., DAB No. 2368 at 9 (2011) (emphasis added).  Therefore, in the present case, Resident 1’s basic ability to leave an SNF did not relieve Petitioner of the duty to consider the risks that Resident 1 may encounter if Resident 1 eloped.  Indeed, if a resident decides to leave a facility, the facility still has an obligation to protect the resident.  Eastwood Convalescent Center, DAB No. 2088 at 10-14 (2007) (finding a facility failed to provide adequate supervision to a resident who left the facility and could make her own decisions, but was wheelchair bound and required regular medications).  The physician order highlighted the need for special precautions for Resident 1.

Although “a resident’s choice to leave the facility may, in a sense, be considered a refusal of the care and supervision the facility would otherwise provide,” the SNF should then take steps to “be aware of when a resident is expected to be returned to the facility and consider factors that would impact the resident’s health and safety when away, such as the resident’s need for medication.”  Venetian Gardens, DAB No. 2286 at 21-22 (2009) (citing Eastwood Convalescent Center, DAB No. 2088 (2007)).  In the present case, the physician order made it clear that Resident 1 would be at risk leaving the facility without a responsible party, which would include the risk of missing her prescribed medications.

There is also a distinction between known, voluntary departures and unknown, unsupervised exits.  Heritage Park, DAB No. 2231 at 9 (“[T]he risk that [the facility] failed to foresee was that [the resident] might elope from the facility if permitted to exit unsupervised.”); 10-11 (“If staff had known that [the resident] was leaving, staff could have ascertained where the resident was going, how long he was to be gone, who he was with, and thus ensured the resident went with proper clothing and medicine.”).  Had facility staff witnessed Resident 1 leave, they would have taken action to ensure the safety of Resident 1.  Tr. 102-03.  But Petitioner did not monitor the front door.  Tr. 77.

A sign-out policy is one example of a facility’s awareness of its responsibility to protect its residents from harm during known, temporary absences from the facility: 

[The SNF’s] sign-out policy also reflects that [the SNF] was aware of its responsibility to take steps to protect residents from harm when they temporarily left the facility.  That

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policy provides that all residents “leaving the premises should be signed out”; provides for how the facility ensures that medications that are scheduled during the absence will be administered; and instructs staff to contact the administrator or the [director of nursing] if a resident tries to leave with an “unauthorized person” or if there are questions about the departure.  Thus, [the SNF] failed to follow its own policies regarding departures, policies that are intended to protect all residents no matter what their mental or legal status.

Heritage Park, DAB No. 2231 at 12 (internal citation omitted).  However, as stated in FFCL 2, Petitioner’s Administrator made it clear that the facility sign-out procedure was only used when a resident voluntarily informed staff that the resident was going to leave the facility, and Petitioner did not implement its policy that there should be an alarm on the front door to alert facility staff when someone leaves the facility.

The record in this case supports CMS’s contention that Petitioner failed to comply with 42 C.F.R. § 483.25(d).  Even if Resident 1 had not demonstrated a propensity for eloping or wandering, she had multiple diagnoses and a past behavioral history that put her at risk of harm when moving about the facility unaccompanied.  Petitioner’s staff knew Resident 1 had a history of seeking to harm herself and that she tended to forget to call or wait for assistance.  Further, it was foreseeable that Resident 1 might not always make a clear-headed decision about leaving the facility because she had depression and bi-polar disorder.  A history of seeking to self-harm meant Resident 1 might make decisions that could be harmful to her.  In addition, Resident 1’s last mental status exam shortly before she left the facility indicated alertness and orientation only x2, with x4 being the highest possible score.  P. Ex. 6.  Although Resident 1 was not designated as an elopement risk, Petitioner’s January 22, 2021 assessment noted that Resident 1 was at an increased risk for elopement due to her diagnoses of depression and bipolar disorder.  P. Ex. 5 at 3.  Further, the January 2021 elopement risk assessment only indicated that Resident 1 “has not been found to be at risk for elopement at this time.”  P. Ex. 5 at 3 (emphasis added).  When Petitioner’s staff recorded 21 instances of Resident 1 feeling hopeless in the days leading to Resident 1’s departure from the facility (CMS Ex. 4 at 19), staff ought to have recognized that the risk of elopement had substantially increased and acted to supervise Resident 1.6  There is no record that Petitioner took any action to do so.

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Facility staff’s inaction concerning Resident 1’s declining emotional state is particularly important to Resident 1’s unwitnessed exit from the facility.  As explained in FFCL 2, the facility failed to implement its own policy to have a mandatory sign-in and sign-out system and an alarm that would sound when someone left the facility.  The facility did not post anyone to monitor the facility’s front door and had no surveillance camera to record who entered or exited the facility.  Although the front door had a buzzer that would sound when someone left, staff ignored it when it would buzz.  As a result, Petitioner’s requirement that residents obtain a pass before leaving the facility could not be enforced since residents could simply leave unwitnessed from the facility.  And this is exactly what Resident 1 did on March 6, 2021.

Petitioner’s failure to implement its policy to reduce the risk of elopements is a significant indication that Petitioner was noncompliant with section 483.25(d).  It is well established that, in cases involving the “quality of care” requirements under section 483.25, 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 residents’ highest practicable physical, mental, and psychosocial well-being, as required by [42 C.F.R.] section 483.25.”  Green Valley Healthcare & Rehab. Ctr., DAB No. 2947 at 6 (2019) (citing The Laurels at Forest Glenn, DAB No. 2182 at 18 (2008)); North Las Vegas Care Ctr., DAB No. 2946 at 6 (2019); Hanover Hill Health Care Ctr., DAB No. 2507 at 6 (2013) (observing that “the Board has long held that a facility’s own policy may be sufficient evidence . . . of what the facility has determined is needed to meet the quality[-]of[-]care requirements in section 483.25”).  Therefore, Petitioner’s failure to implement its own policy provides strong support for CMS’s determination of noncompliance in this case.

Finally, I find the facility’s refusal to accept any responsibility for the situation involving Resident 1 to be troubling.  When Resident 1’s daughter objected that Petitioner was “supposed to take care of her mother and she is not supposed to be on the street,” staff responded that Resident 1 “is self-responsible, and able to make decisions for herself. . . .”  CMS Ex. 5 at 4.  Petitioner provided similar statements when it belatedly reported Resident 1’s absence to the state agency.  CMS Ex. 5 at 8.  However, the issue in this case is not whether the facility was honoring a resident’s right to make decisions for herself.  Rather, it is about a facility that had no method of knowing whether residents left the facility in a manner that is dangerous for them.  As Petitioner’s Administrator testified, had staff seen Resident 1 leaving the facility, they would have attempted to persuade her to return and, being unsuccessful, would call the police and stay with her until a family member showed up.  Tr. 102-03.  However, because Petitioner made no effort to monitor who was leaving the facility, Resident 1 was able to push her wheelchair backwards out the front door without anyone at the facility being aware.  It is this absolute lack of supervision that is at issue.  Therefore, I conclude that Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(d).

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10. CMS’s determination that Petitioner’s noncompliance with 42 C.F.R. § 483.25(d) 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.  The regulation does not require that a resident actually be harmed.  Lakeport Skilled Nursing Ctr., DAB No. 2435 at 8 (2012).

I must uphold CMS’s determination as to the level of a facility’s substantial noncompliance (which includes an immediate jeopardy finding) unless it is “clearly erroneous.”  42 C.F.R. § 498.60(c).  The “clearly erroneous” standard imposes on facilities a heavy burden to show no immediate jeopardy, and administrative appellate cases have sustained determinations of immediate jeopardy where CMS presented evidence “from which ‘[o]ne could reasonably conclude’ that immediate jeopardy exists.”  See, e.g., Barbourville Nursing Home, DAB No. 1962 at 11 (2005) (quoting Florence Park Care Ctr., DAB No. 1931 at 27-28 (2004)).  In reviewing CMS’s finding, I “must consider whether the totality of the allegations support the Agency’s determination that [the SNF’s] noncompliance ‘has caused, or [was] likely to cause, serious injury, harm, impairment, or death to a resident.’”  Rosewood Care Ctr., 868 F.3d 605, 618 (7th Cir. 2017) (emphasis omitted).

CMS contends that its immediate jeopardy finding is appropriate because Petitioner failed to properly supervise Resident 1, who was homeless in downtown Los Angles for over one week without medication or consistent access to food, and who suffered a CVA requiring hospitalization.  CMS Br. at 23-24.  CMS also argues that Resident 1’s diminished capacity put her at even greater risk of harm due to her inability to help herself if she were injured while away from the facility.  CMS Br. at 24.  Finally, CMS argues that Petitioner’s failure was likely to cause serious harm to its other vulnerable residents.  CMS Br. at 23-24.

Petitioner argues that there was no noncompliance with 42 C.F.R. § 483.25(d) from which CMS could determine its residents’ health and safety was immediately jeopardized.  P. Br. at 20-22.

Immediate jeopardy can be based simply on risks posed to residents by being away from the facility for mere hours when medical monitoring and medication administration are needed:  

Like the ALJ, we can find no error, much less clear error, in CMS’s determination that there was a likelihood that serious harm would befall Resident 500 under the circumstances.  The resident was highly compromised medically and totally

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dependent on nursing staff for her care, including care of her dialysis access site and the administration of multiple medications on schedule.  The resident was gone for four and one-half hours, by [the SNF’s] own calculations, without staff awareness of where she was, and the resident missed doses of her insulin, hypertension and antipsychotic medications.  It was certainly foreseeable that serious harm could befall Resident 500, whether by way of the accident that actually occurred or by way of another accident caused by outside forces (e.g. a traffic accident) or by her own, highly compromised medical condition.

Eastwood Convalescent Center, DAB No. 2088 at 16-17 (2007).

The evidence is clear that, given Resident 1’s limited ability to move her wheelchair and the lack of medical monitoring and medication administration after she left the facility, she was both at risk for significant harm and was in fact harmed by Petitioner’s failure to monitor the front door of the facility or otherwise supervise Resident 1.  See CMS Ex. 6; CMS Ex. 13 ¶ 13.  Resident 1’s description of her week of being homeless also demonstrates the jeopardy in which she was placed due to Petitioner’s failure to supervise her.  CMS Ex. 13 ¶ 14.  Resident 1 missed a week of daily medications to manage her seizures, diabetes, depression, and to prevent future strokes.  CMS Ex. 4 at 4-5.  As the nurse surveyor testified: 

Resident 1 took medications daily or more frequently for hypertension (high blood pressure), seizures, and diabetes.  [CMS Ex. 4] at 4-5.  She needed insulin injections before meals and at bedtime.  [CMS Ex. 4] at 5.  Failure to take the medications consistently as prescribed would put her in danger of grave illness including kidney damage, seizure, stroke, or possibly death.

CMS Ex. 13 ¶ 7.  As explained in FFCL 7, the hospital ED’s assessment of Resident 1 on March 13, 2021, showed significant medical complications had occurred due to Resident 1’s absence from the facility for a week, including a CVA, uncontrolled blood pressure, and uncontrolled blood sugar levels.

As explained above, Petitioner failed to implement its policy to reduce the risk of elopement, which made it impossible for Petitioner to properly implement Resident 1’s physician order that Resident 1 was only to be allowed out of the facility on pass with a responsible party.  This is highly problematic because, as the nurse surveyor testified, the underlying basis for the physician’s order was to protect Resident 1 from significant harm: 

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This requirement to be accompanied when going out was consistent with the fact that Resident 1 had deficits that made her vulnerable [and] posed a danger to her health when she was unattended outside the facility.  From my review of Resident 1’s records, a skilled nursing facility should not have allowed her to the leave the facility by herself.  Besides potentially needing assistance to take her medications due to immobility on her right side, residents with a history of depression and feeling hopeless may try to hurt themselves and therefore must be carefully monitored.

 CMS Ex. 13 ¶ 19 

In this case, Resident 1 was subjected to serious injury and harm when she suffered a CVA while away from the facility.  CMS Ex. 13 ¶ 19.  Further, as the nurse surveyor testified, Resident 1 was also subject to risk of the following:  1) serious injury or potential death during a fall; 2) kidney damage and potentially death due to untreated high blood sugar; 3) seizure due to untreated epilepsy; 4) heart attack, aneurism, heart failure, or potential death due to untreated high blood pressure; and 5) self-harm or other dangerous behavior from lack of supervision and untreated mental illness.  CMS Ex. 13 ¶ 19.  The nurse surveyor further testified that a “[f]ailure to take medications consistently as prescribed would put [Resident 1] in danger of grave illness including kidney damage, seizure, stroke, or possible death.”  CMS Ex. 13 ¶ 7.

Based on the foregoing, I conclude that CMS did not clearly err in determining that Petitioner’s noncompliance with 42 C.F.R. § 483.25(d) posed immediate jeopardy to the health and safety of its residents.

11. Although Petitioner completed its plan of correction by March 21, 2021, Petitioner failed to meet its burden under 42 C.F.R. § 488.454(e) to provide acceptable documentation to show that it was both in substantial compliance with Medicare requirements and could maintain substantial compliance with Medicare requirements as of March 21, 2021.  Therefore, I uphold the duration of noncompliance found by the state agency based on a revisit survey at Petitioner’s facility.

CMS imposed a $7,460 per‑day CMP for two days from March 18, 2021, through March 19, 2021, and a $225 per-day CMP for 54 days from March 20, 2021, through May 12, 2021, for a total CMP of $27,070.  CMS Ex. 2 at 2. Petitioner argues that it implemented its plan of correction and returned to substantial compliance effective March 21, 2021, and that CMS improperly set May 13, 2021, i.e., the date of the revisit survey, as the date for Petitioner’s return to compliance.  P. Br. at 2, 23-27.  Petitioner stated the following:

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[T]he facility should be deemed to have returned to substantial compliance effective March 21, 2021 – the date all corrective actions were completed and verified by the surveyor on revisit.  All evidence and testimony presented at hearing establish that Osage implemented all corrective actions by March 21, 2021 and thus, there is no basis for CMS to impose any remedies after the facility returned to substantial compliance.  The remedies must be adjusted accordingly.

P. Br. at 2.  Therefore, Petitioner believes that the duration for the per-day CMPs should end on March 20, 2021.  P. Br at 23-27; see also Mimiya Hospital, DAB No. 1833 at 7 (2002), aff’d 331 F.3d 178 (1st Cir. 2003).

Although Petitioner bases its argument on the date it asserts Petitioner completed its plan of correction, Petitioner’s date for completion of its plan of correction is not the legal standard for determining the duration of a per-day CMP.

Once a state agency finds an SNF to be noncompliant with Medicare requirements, the SNF remains so until it affirmatively demonstrates that it has achieved substantial compliance once again.  Ridgecrest Healthcare Ctr., DAB No. 2493 at 2-3 (2013); Taos Living Ctr., DAB No. 2293 at 20 (2009); Premier Living & Rehab. Ctr., DAB No. 2146 at 3 (2008); Lake City Extended Care, DAB No. 1658 at 12-15 (1998).  Enforcement remedies continue until the state agency determines that the SNF has returned to substantial compliance during a revisit survey or by “credible written evidence that [CMS or the state agency] can verify without an on-site visit.”  42 C.F.R. § 488.454(a)(1).  During a “revisit survey,” state surveyors must “evaluate the extent to which previously-cited deficiencies have been corrected and the provider or supplier is in substantial compliance with applicable conditions of participation, requirements, or conditions for coverage.”  42 C.F.R. § 488.30(a) (emphasis added).

The SNF bears the burden of showing that its noncompliance was of a shorter duration than found by CMS.  Owensboro Place & Rehab. Ctr., DAB No. 2397 at 12 (2011) (citing Kenton Healthcare, LLC, DAB No. 2186 at 24-25 and Lake Mary Health Care, DAB No. 2081 at 30 (2007)).  Therefore, the burden is on the SNF to prove that it returned to substantial compliance and CMS does not need to prove that deficiencies continued to exist.  Asbury Care Ctr. at Johnson City, DAB No. 1815 at 19-20 (2002).

If an SNF believes that enforcement remedies should end on a date earlier than the revisit survey, then Petitioner must meet the following regulatory requirement: 

If the facility can supply documentation acceptable to CMS or the State survey agency that it was in substantial compliance

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and was capable of remaining in substantial compliance, if necessary, on a date preceding that of the revisit, the remedies terminate on the date that CMS or the State can verify as the date that substantial compliance was achieved and the facility demonstrated that it could maintain substantial compliance, if necessary.

42 C.F.R. § 488.454(e) (emphasis added); see also Ridgecrest Healthcare Ctr., DAB No. 2493 at 15 (2013) (“As the Board has recognized, a [plan of correction] indicating a specific date of implementation is not sufficient evidence by itself to establish that the measures in the [plan of correction] had been satisfactorily implemented.”); Oceanside Nursing & Rehab. Ctr., DAB No. 2382 at 20 (2011) (“Even if a [plan of correction] is accepted, the facility is not regarded as in substantial compliance until CMS determines, ‘usually through a revisit survey,’ that the deficiency no longer exists.”); Tr. 43:8-45:5; 49:6-51:4; 53:2-15; 55:4-10; 56:1-15 (testimony of Surveyor McClendon that revisit surveys are conducted to ensure that the corrective measures in the corrective action plan are actually continued, and that CMS must make the determination of compliance).  Therefore, in order for me to reduce the duration of the CMP in this case, Petitioner must show that it not only returned to substantial compliance before the revisit survey but also that there is sufficient evidence that Petitioner could maintain substantial compliance.

In the present case, the state agency had to conduct a revisit survey because the original survey found a deficiency that immediately jeopardized the health and safety of residents.  Tr. 53; State Operations Manual, CMS Pub. 100-07, Chapter 7, Survey and Enforcement Process for Skilled Nursing Facilities and Nursing Facilities (SOM-Chapter 7), § 7317.2(1), at 82-83 (Rev. 63, eff. Sept. 10, 2010).  Petitioner submitted a plan of correction on April 22, 2021, which outlined the measures it intended to take to achieve substantial compliance.  See CMS Ex. 8 (Petitioner’s plan of correction).

In the plan of correction, Petitioner identified several actions it would take by March 21, 2021, in an effort to correct its noncompliance, including assigning a staff member to supervise the main lobby and entrance door, and training staff on elopement issues.  CMS Ex. 8 at 1-3.  Petitioner also identified several systemic changes as well as measures for compliance, including ensuring residents who had out-on-pass orders were only leaving with responsible parties.  CMS Ex. 8 at 3-5.  Finally, Petitioner indicated it intended to present the results of the reviews and inspections “for review and recommendations monthly for the next 3 months and quarterly thereafter until substantial compliance is achieved.”  CMS Ex. 8 at 6 (emphasis added).

Therefore, by its own terms, the plan of correction included measures requiring “sustained action by Petitioner,” which means a revisit survey was necessary to confirm that Petitioner was continuing to implement the changes and that the changes actually corrected the noncompliance.  Tr. 56; see Oceanside Nursing and Rehab Ctr., DAB No.

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2383 at 17 (2011) (“[S]ince they operated prospectively, CMS could reasonably require evidence that the new practices and requirements were actually put into effect in order to verify that the facility had attained substantial compliance.”).

The state agency conducted a revisit survey in less than two months.  It seems reasonable for the state agency to return when it did to allow Petitioner sufficient time to be able to show both a return to substantial compliance and an ability to maintain compliance.

12. The $7,460 per‑day CMP for 2 days from March 18, 2021, through March 19, 2021, and a $225 per-day CMP for 54 days from March 20, 2021, through May 12, 2021, for a total CMP of $27,070 is reasonable and appropriate under relevant statutory and regulatory factors for determining the amount of CMPs.

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

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

CMS asserts that the CMP is reasonable because Petitioner failed to properly supervise a resident who was then able to leave the facility, Petitioner failed to timely report the resident’s elopement, and the resident suffered serious harm by way of a stroke while she was missing from Petitioner’s facility and without her medications.  CMS Br. at 24-26.

Other than arguing that the facility achieved substantial compliance on March 21, 2021, the date it implemented its plan of correction, Petitioner does not argue that the CMP is unreasonable based on the regulatory factors.  P. Br. at 24-27.  Because Petitioner did not

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contend that a particular regulatory factor does not support the CMP amounts, I must sustain them.  Coquina Ctr., DAB No. 1860 (2002).

I note that the $7,460 per‑day CMP for 2 days from March 18, 2021, through March 19, 2021, and the $225 per-day CMP for 54 days from March 20, 2021, through May 12, 2021, for a total CMP of $27,070, are near the bottom of the respective penalty ranges for noncompliance.  Therefore, the penalty amounts, being uncontested and nearly the minimum amounts that CMS could impose, I uphold those amounts.

V.     Conclusion

1. CMS’s determination that Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(d) is sustained.
2. CMS did not clearly err when it determined that Petitioner’s noncompliance with 42 C.F.R. § 483.25(d) posed immediate jeopardy to resident health and safety.
3. Petitioner did not establish that, prior to May 13 2021, it returned to substantial compliance with Medicare requirements and was able to demonstrate that it could maintain such compliance.
4. The $7,460 per-day CMP for the period of immediate jeopardy for 2 days beginning March 18, 2021, and continuing through March 19, 2021, and the $225 per-day CMP for the period of non-immediate jeopardy for 54 days beginning March 20, 2021, and continuing through May 12, 2021, for a total CMP of $27,070, are reasonable and appropriate.