Bridgewater Rehabilitation Centre, DAB CR5482 (2019)

DECISION

Bridgewater Rehabilitation Centre (Petitioner or the facility), is a skilled nursing facility (SNF) located in Hartford City, Indiana, that participates in the Medicare program. The Indiana State Department of Health (state agency) conducted a survey of the facility from February 6, 2017 to February 7, 2017. Based on the survey findings, the Centers for Medicare & Medicaid Services (CMS) determined that Petitioner was not in substantial compliance with Medicare program participation requirements at 42 C.F.R. § 483.25(d)(1) and (2). CMS also determined that Petitioner’s noncompliance posed immediate jeopardy to resident health and safety. On the basis of these findings, CMS imposed two remedies: a two-year prohibition on conducting a Nurse Aide Training and Competency Evaluation Program (NATCEP) and a per-instance civil money penalty (CMP) of $18,812. Petitioner contests CMS’s findings of noncompliance and asserts that it was in substantial compliance with the aforementioned regulatory requirements.

For the reasons discussed below, I reach the following conclusions: (1) Petitioner did not substantially comply with the Medicare participation requirements found at 42 C.F.R. § 483.25(d)(1) and (2); (2) CMS’s immediate jeopardy determination is not subject to review in this case; and (3) the amount of the per-instance CMP is reasonable.

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I. Background and Procedural History

Following a January 30, 2017 incident in which a resident eloped from Petitioner’s facility, the state agency initiated a complaint investigation on February 6, 2017. CMS Exhibit (Ex.) 1 at 1. The investigation resulted in a partial extended survey which was completed on February 7, 2017. Id.

Based on the survey findings, CMS determined that the facility had not substantially complied with 42 C.F.R. § 483.25(d)(1) and (2) (Tag F323). The regulations require the facility to ensure that the resident’s environment remains as free from accident hazards as is possible and that each resident receives adequate supervision and assistance devices to prevent accidents. CMS cited the facility’s noncompliance at a scope and severity level “K.”CMS and state survey agencies consider the scope and severity of deficiencies when selecting enforcement remedies. CMS summarizes the scope and severity levels in a matrix published in the State Operations Manual (SOM). SOM, CMS Pub. 100-07, chap. 7, § 7400.5.1 (Rev. 161, effective Sept. 23, 2016, was applicable at the time of the survey at issue; pursuant to Rev. 185, issued November 16, 2018, the matrix currently appears at section 7400.3.1 of the SOM, but the substance is largely unchanged). The matrix, which is based on 42 C.F.R. § 488.408, specifies which remedies are required and optional at each scope and severity level. “Scope” describes how many residents are potentially affected by a particular deficiency. Deficiencies may be “isolated,” “pattern,” or “widespread” in scope. “Severity” describes the possible harm that a deficiency may cause. A scope and severity level of A, B, or C describes a deficiency that causes no actual harm with the potential for minimal harm. Facilities cited with deficiencies at level C or lower remain in substantial compliance. 42 C.F.R. § 488.301. A scope and severity level of D, E, or F describes a deficiency that has caused no actual harm with the potential for more than minimal harm that is not immediate jeopardy. A scope and severity level of G, H, or I describes a deficiency that has caused actual harm that is not immediate jeopardy. Scope and severity levels J, K, and L describe deficiencies that pose immediate jeopardy to resident health or safety. CMS Ex. 21 at 1; see CMS Ex. 1.

The state agency completed a revisit of the facility on May 10, 2017. CMS Ex. 21 at 2. Following the revisit, CMS accepted the state agency’s recommendation that the facility returned to substantial compliance as of February 8, 2017. Id. By letter dated June 8, 2017, CMS notified Petitioner that it was imposing a per‑instance CMP of $18,812 and a two-year prohibition on conducting a NATCEP. Id. at 1-2, 4.

Petitioner filed two separate hearing requests: the first on April 11, 2017, the second on July 25, 2017. This case was originally assigned to Administrative Law Judge Scott Anderson, who issued an acknowledgement and pre-hearing order (Pre-hearing

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Order), as well as an order consolidating Petitioner’s hearing requests for hearing and decision.

This case was reassigned to me on August 25, 2017. In accordance with Judge Anderson’s Pre-hearing Order, CMS filed a pre-hearing exchange, consisting of a combined motion for summary judgment and pre-hearing brief (CMS Br.) and 22 proposed exhibits, including the written declarations of two proposed witnesses (CMS Exs. 1-22). Petitioner filed a series of documents as part of its pre-hearing exchange: (1) a motion for summary disposition and brief in supportPetitioner also filed an amendment to its motion for summary disposition correcting a scrivener’s error contained in the original version. DAB E-File docket entry 8. I interpret this filing as a motion to amend its motion for summary disposition. As CMS did not object to Petitioner’s amendment, I grant Petitioner’s implicit request to amend its motion for summary disposition to correct its scrivener’s error. (P. MSD); (2) an alternative motion for partial summary disposition and combined brief in support of its motion and in opposition to CMS’s motion for summary judgmentIn support of its alternative motion for partial summary disposition, Petitioner filed two exhibits it labeled as P. Exs. K and L. Those exhibits were also filed as part of its pre hearing exchange as P. Exs. 16 and 17. As labeled, P. Exs. K and L do not comply with Judge Anderson’s Pre-hearing Order. However, Petitioner corrected its error by filing the exhibits with its pre-hearing exchange in the correct format. Therefore, any reference to the exhibits will be to P. Ex. 16 or P. Ex. 17. ; (3) a corrected combined brief in support of its alternative motion for partial summary disposition and in opposition to CMS’s motion for summary judgmentPetitioner filed a corrected combined brief in support of its alternative motion for summary disposition and in opposition of CMS’s motion for summary judgment, indicating that it was filing a corrected version to correct erroneous references identifying the resident at issue in this case. I interpret this filing as a request to withdraw the original version of Petitioner’s brief (DAB E-File docket entry 12) and substitute with the corrected version of the brief (DAB E-File docket entry 13). As CMS did not object to Petitioner filing a corrected version of its brief, I grant Petitioner’s implicit request insofar as I consider only the corrected version of the brief in rendering my decision. (P. PSD); and (4) 17 proposed exhibits, including nine written declarations for eight proposed witnesses (P. Exs. 1-17).P. Ex. 10 and P. Ex. 16, respectively, are the affidavit and a “supplemental” affidavit of Petitioner’s proposed witness, Cheryl Toomey. CMS later filed replies opposing both Petitioner’s cross-motion for summary disposition and alternative motion for partial summary disposition. In turn, Petitioner filed sur-replies to CMS’s oppositions.

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While both parties offered the written direct testimony of witnesses, neither party requested to cross examine the opposing party’s witnesses. As Judge Anderson’s Pre‑hearing Order informed the parties, a hearing is only necessary if a party requests to cross-examine a witness. Pre-hearing Order ¶¶ 8-10. Although the parties cross-moved for summary judgment, because an in-person hearing to cross-examine witnesses is not necessary, I decide the case based on the written record, without considering whether the standards for summary judgment are satisfied. As neither party objected to the exhibits proposed by the opposing party, I admit CMS Exs. 1-22 and P. Exs. 1-17 into the record. Pre-hearing Order ¶ 7.

II. Issues

1. Whether Petitioner was in substantial compliance with Medicare participation requirements at 42 C.F.R. § 483.25(d)(1) and (2) (Tag F323);
2. If Petitioner was not in substantial compliance with Medicare participation requirements, then whether CMS’s immediate jeopardy determination is subject to my review; and
3. Whether the remedies imposed are reasonable.

III. Jurisdiction

I have jurisdiction to hear and decide this case. Social Security Act (Act) §§ 1128A(c)(2), 1819(h)(2)(B)(ii) (codified at 42 U.S.C. §§ 1320a-7a(c)(2), 1395i‑3(h)(2)(B)(ii)); 42 C.F.R. §§ 488.408(g), 488.434(a)(2)(viii), 498.3(b)(13).

IV. Discussion

A. Statutory and Regulatory Background

The Act sets requirements for SNFs to participate in the Medicare program and authorizes the Secretary of Health & Human Services (Secretary) to promulgate regulations implementing those statutory provisions. Act § 1819 (42 U.S.C. § 1395i-3). The Secretary’s regulations are found at 42 C.F.R. part 483 and 488.

To participate in the Medicare program, a SNF must maintain substantial compliance with program requirements. To be in substantial compliance, a 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. A deficiency is a violation of a participation requirement established by section 1819(b)-(d) of the Act (42 U.S.C. § 1395i-3(b)-(d)), or the Secretary’s regulations at 42 C.F.R. pt. 483, subpt. B. Id. “Noncompliance” means “any deficiency that causes a facility to not be in substantial compliance.” Id.

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The Secretary contracts with state agencies to conduct periodic surveys to determine whether SNFs are in substantial compliance with the participation requirements. Act § 1864(a) (42 U.S.C. § 1395aa(a)); 42 C.F.R. § 488.10. The Act also authorizes the Secretary to impose enforcement remedies against SNFs that do not comply with the participation requirements. Act § 1819(h)(2) (42 U.S.C. § 1395i-3(h)(2)). The regulations specify the enforcement remedies that CMS may impose if a facility is not in substantial compliance. 42 C.F.R. § 488.406. Among other enforcement remedies, CMS may impose a per-instance CMP for each instance that a facility is not in substantial compliance. 42 C.F.R. § 488.430(a). The regulations specify that the per-instance CMP will be in the range of $2,097 - $20,965, for each instance of noncompliance.CMS increases the CMP amounts annually to account for inflation in compliance with the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, Pub. L. No. 114-74, § 701, 129 Stat. 584, 599 (2015). See 81 Fed. Reg. 61,538 (Sept. 6, 2016). Because CMS imposed the CMP in this case after February 3, 2017, the inflation-adjusted amounts for 2017 apply. 82 Fed. Reg. 9174, 9182 (February 3, 2017). 42 C.F.R. § 488.438(a)(2); 45 C.F.R. § 102.3.

If CMS imposes a remedy, such as a CMP, based on a noncompliance determination, then the facility may request a hearing before an administrative law judge to determine whether there was a basis for the deficiency findings that led to the imposition of the remedy and whether the CMP imposed was reasonable. Act §§ 1128A(c)(2) (42 C.F.R. § 1320a-7a(c)(2)), 1819(h)(2)(B)(ii) (42 C.F.R. § 1395i(h)(2)(B)(ii); 42 C.F.R. §§ 488.408(g), 488.434(a)(2)(viii), 498.3(b)(13). However, the facility may not appeal CMS’s choice of remedies. 42 C.F.R. § 488.408(g)(2).

CMS has the burden to come forward with evidence sufficient to make a prima facie showing that Petitioner is out of substantial compliance with participation requirements to establish a basis to impose an enforcement remedy. See, e.g., Evergreene Nursing Care Ctr., DAB No. 2069 at 7 (2007). If CMS makes this prima facie showing, then Petitioner bears the ultimate burden of persuasion as to whether it substantially complied. In other words, Petitioner must show, by a preponderance of the evidence, on the record as a whole, that it was in substantial compliance with participation requirements. Id. Petitioner has both the burden of coming forward and the burden of persuasion as to any affirmative defense. Id.; Batavia Nursing & Convalescent Inn, DAB No. 1911 (2004), aff’d, Batavia Nursing & Convalescent Ctr. v. Thompson, 129 F. App’x 181 (6th Cir. 2005).

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B. Findings of Fact, Conclusions of Law, and Analysis

1. Petitioner did not substantially comply with the Medicare participation requirements at 42 C.F.R. § 483.25(d)(1) and (2) (Tag F323).My conclusions of law appear as headings and subheadings in bold italic type. My findings of fact appear in the supporting text.

Section 483.25 of 42 C.F.R., which governs quality of care, provides generally that “the facility must ensure that residents receive treatment and care in accordance with professional standards of practice, the comprehensive person-centered care plan, and the resident’s choices.” Subsection 483.25(d) imposes specific obligations upon a facility to minimize accident hazards and prevent accidents, as follows:

The facility must ensure that –

(1) The resident environment remains as free of accident hazards as is possible; and

(2) Each resident receives adequate supervision and assistance devices to prevent accidents.

Appellate panels of the Departmental Appeals Board (DAB) have held that the regulations require that a facility address foreseeable risks of harm from accidents “by identifying and removing hazards, where possible, or where the hazard is unavoidable because of other resident needs, managing the hazard by reducing the risk of accident to the extent possible.” Meadowwood Nursing Ctr., DAB No. 2541 at 2 (2013) (citing Me. Veterans’ Home – Scarborough, DAB No. 1975 at 10 (2005)).In 2016, CMS issued a final rule that re-designated and revised the provisions of 42 C.F.R. Part 483. See Final Rule, Medicare and Medicaid Programs; Reform of Requirements for Long-Term Care Facilities, 81 Fed. Reg. 68,688, 68,828 (Oct. 4, 2016). Prior to 2016, the content of subsections 483.25(d)(1) and (2) was codified at subsections 483.25(h)(1) and (2). The Meadowwood decision interpreted 42 C.F.R. § 483.25(h)(1) and (2), as did the other decisions cited in this paragraph. I find it appropriate to rely on the reasoning of these decisions in the present case because there was no substantive change to the language when 42 C.F.R. § 483.25(h)(1) and (2) were recodified as § 483.25(d)(1) and (2). Subsection 483.25(d)(2) requires that a facility take “all reasonable steps to ensure that a resident receives supervision and assistance devices that meet his or her assessed needs and mitigate foreseeable risks of harm from accidents.” Briarwood Nursing Ctr., DAB No. 2115 at 11 (2007) (citing Woodstock Care Ctr. v. Thompson, 363 F.3d 583, 590 (6th Cir. 2003)

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(facility must take “all reasonable precautions against residents’ accidents”)). Facilities are given “the flexibility to choose the methods” they use to provide supervision or assistive devices to prevent accidents, so long as the chosen methods “constitute an ‘adequate’ level of supervision under all circumstances.” Windsor Health Care Ctr., DAB No. 1902 at 5 (2003), aff’d sub nom Windsor Health Ctr. v. Leavitt, 127 F. App’x 843 (6th Cir. 2005).

CMS found Petitioner out of compliance with 42 C.F.R. § 483.25(d)(1) and (2) after one of its residents, D.C.,I refer to the affected resident by her initials to protect her privacy and to avoid confusion. The statement of deficiencies (SOD) refers to the affected resident as “Resident B.” See, e.g., CMS Ex. 1 at 2. Similarly, Petitioner’s corrected combined brief refers to the affected resident as “Resident B.” See P. PSD at 1 n.1. However, the surveyor notes and the resident key refer to the affected resident as “Resident G.” CMS Ex. 14; see also, e.g., CMS Ex. 2 at 1. In her declaration, Tina Smith-Staats, one of the state agency surveyors, explains that when she drafted the SOD, she “inadvertently” referred to the resident as “Resident B.” CMS Ex. 18 at ¶ 6. Petitioner does not dispute that the incident described in the SOD occurred or that D.C. was the affected resident. eloped on the evening of January 30, 2017. For the reasons explained below, I agree that Petitioner failed to comply substantially with the cited regulation.

I find the following facts by a preponderance of the evidence, based on my review of the entire record in this case. At the time of the incident, D.C. was a 90-year-old woman with diagnoses of, among other things, dementia with behavioral disturbances, diabetes type 2, chronic obstructive pulmonary disease (COPD), hypertension, and depression. CMS Ex. 2 at 1, 8. She was admitted to Petitioner’s facility on January 30, 2017 at 12:15 p.m. after being discharged from her previous SNF. CMS Ex. 3 at 1; P. Ex. 1 at ¶ 10. At the SNF from which she had transferred, D.C. had resided in a locked unit and was identified as an elopement risk. CMS Ex. 2 at 6; CMS Ex. 18 at ¶ 10.

Petitioner’s staff completed an assessment of D.C. at the time she was admitted to the facility. The assessment concluded that she was “at risk” for elopement. CMS Ex. 2 at 13. In particular, the elopement risk assessment noted that D.C. had a history of wandering, had expressed a desire to leave the facility, and had exhibited exit-seeking behaviors. Id. In addition, on the date of admission, Petitioner completed a care plan for D.C., which noted, “[t]he resident has been found to be at risk for elopement due to: Being in a dementia unit (locked).” CMS Ex. 2 at 6. Among the interventions listed on the care plan were to (1) complete the elopement risk assessment; (2) use re-direction when resident attempts to exit building; (3) notify supervisor of exit-seeking behavior; and (4) follow facility policy and procedure should elopement occur. Id. After D.C. eloped, Petitioner’s staff updated the care plan to reflect that the resident had managed to

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exit the facility and to add interventions including 30-minute checks and one on one supervision. Id. at 7.

In a progress note for 3:00 p.m. on January 30, 2017 (the date of admission), L.M., a Licensed Practical Nurse (LPN) employed at the facility, documented that D.C. was ambulating in the hallway with her rolling walker and that she was alert and confused. CMS Ex. 3 at 1. In a progress note for 5:30 p.m. the same day, LPN L.M. recorded that D.C. was ambulating in the hallway and exhibiting exit-seeking behavior. Id. During the survey, Certified Nursing Assistant (CNA) E.T. told the surveyor that D.C. had attempted to open the exit door at the “west end of the 200 hall.”CMS Ex. 8 is a diagram of the facility. CMS Ex. 18 at ¶ 12. In infer that CNA E.T. was describing the hallway on which resident rooms numbered 200-222 are located. That hallway is also labeled the “South Hall” on the diagram. The surveyor circled the exit door through which D.C. attempted to elope and wrote “1st attempt” on the diagram. CMS Ex. 8. She also wrote “actual elopement” next to the marked exit at the end of the “North Hall,” on which resident rooms 111-121 are located. Id. CMS Ex. 18 at ¶ 15; see also CMS Ex. 17 at 6. CNA E.T. reported that she intercepted the resident, moved her back to her room, and “left her as she no longer appeared restless.” P. Ex. 5 at ¶ 6; see also CMS Ex. 17 at 6; CMS Ex. 18 at ¶ 15. According to the 5:30 p.m. entry in the progress notes, Petitioner’s staff initiated 30-minute checks of D.C. at that time. CMS Ex. 3 at 1. Facility documents show that LPN L.M. carried out 30-minute checks at 5:30 p.m., 6:00 p.m., and 6:30 p.m. CMS Ex. 4 at 1. LPN L.M. and LPN J.H. both stated that they last saw D.C. at 6:30 p.m. outside the respiratory office. CMS Ex. 13 at 6-7, 12. At approximately 6:30 p.m., a nurse called the Assistant Director of Nursing (ADON), A.S., to report that D.C. was exhibiting exit-seeking behavior and increased anxiety.ADON A.S. did not identify the nurse who informed her about D.C.’s increased anxiety. See P. Ex. 4 at ¶ 6. I infer that the staff member was A.L., who provided a written statement as part of Petitioner’s internal investigation of the incident. See CMS Ex. 13 at 15; see also id. at 14. A.L. reported that, at 6:29 p.m., she notified ADON A.S. by text message that D.C. “won’t stay still for even 5 seconds, is going into other resident’s [sic] rooms [and] trying to get out.” Id. at 15. P. Ex. 4 at ¶ 6; CMS Ex. 13 at 15. In response to that report, ADON A.S. spoke to LPN L.M. by telephone. LPN L.M. told the ADON that D.C. “was in a Bridgewater hallway in sight of [L.M.].” P. Ex. 4 at ¶ 6; see also P. Ex. 6 at ¶ 7. At 6:36 p.m., ADON A.S. sent Petitioner’s Director of Nursing (DON) a text message that described D.C. as “freaking out trying to get out the door and is in and out of other resident rooms and is requiring one on one.” CMS Ex. 12.

At about 6:40 p.m., CNA E.T. notified LPN L.M. that she could not locate D.C. P. Ex. 5 at ¶ 6; see also CMS Ex. 3 at 1. LPN L.M. called a “code gray” indicating that a resident’s whereabouts were unknown. P. Ex. 6 at ¶ 8; see also CMS Ex. 7 at 3.

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LPN M.C., CNA E.T., and other staff began searching the facility. As they approached the North Hall, they heard the exit door alarm at the end of the hall. Staff also searched outside the North Hall exit for the resident. CMS Ex. 8; CMS Ex. 13 at 5, 9, 13, 15; CMS Ex. 18 at ¶¶ 17, 18. At 6:47 p.m., LPN M.C. called 911 to report D.C. missing. CMS Ex. 13 at 14. According to the police report, at 18:48 (6:48 p.m.), about the same time the missing person call came in, a passerby brought D.C. to the Hartford City Police Department. CMS Ex. 5. The passerby reported that he had been driving in the area and stopped to pick up D.C. when he saw her walking outside with no coat or shoes. Id. On the day that D.C. eloped, the high temperature for the day was 35 degrees Fahrenheit and the low temperature was 17 degrees Fahrenheit. CMS Ex. 18 at ¶ 16; see also CMS Ex. 13 at 1 (temperature 29 degrees Fahrenheit). D.C. was taken to the emergency room for an examination. CMS Ex. 6. The emergency room discharge papers show no signs of injury, but the physician on duty prescribed an antibiotic to treat a urinary tract infection (UTI or bladder infection). CMS Ex. 6 at 2, 6; see also CMS Ex. 17 at 5.

Based on these facts, as I explain in the following subsections, Petitioner did not take all reasonable steps to ensure that D.C. received adequate supervision and assistance devices to mitigate the foreseeable risks of harm she faced when eloping unobserved. Nor did Petitioner take all reasonable measures to protect D.C. and any other residents at risk for elopement by ensuring that its exit door alarms were functioning properly.

1. Petitioner did not take all reasonable measures to adequately supervise a resident who was a known elopement risk.

Petitioner makes two main arguments in support of its contention that its supervision of D.C. substantially complied with 42 C.F.R. § 483.25(d). First, Petitioner maintains that it was unforeseeable that D.C. would elope from the facility. Second, Petitioner argues that, under the circumstances of this case, citing a deficiency amounts to imposing strict liability on Petitioner. I am not persuaded by either argument.

As to the first argument, Petitioner asserts that it could not have foreseen that D.C. would elope because no one communicated to facility staff that D.C. had a history of exit‑seeking behavior and D.C. never previously eloped from the facility. P. MSD at 9, 19, 21. Petitioner cites to several decisions affirming deficiency findings for inadequate supervision because, among other things, residents had eloped from facilities more than once. P. MSD at 21-23, citing Liberty Commons Nursing & Rehab. Ctr. - Alamance v. Leavitt, 285 Fed. Appx. 37 (4th Cir. 2008); Woodstock Care Ctr. v. Thompson, 363

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F.3d 583 (6th Cir. 2003); and Asheville Health Care Ctr., DAB CR2214The Asheville decision was issued by a DAB administrative law judge. Administrative law judge decisions are not precedential and do not bind appellate panels or other administrative law judges. See, e.g., Littlefield Hospitality, DAB No. 2756 at 13 (2016) (and cases cited therein). (2010). However, while the cited decisions uphold deficiency findings where residents eloped on more than one occasion, they do not hold that a facility is in substantial compliance if a resident has not previously succeeded in eloping. To the contrary, as an appellate panel of the DAB has explained, “For a risk to be foreseeable, it need not have been made obvious by having already materialized.” Josephine Sunset Home, DAB No. 1908 at 14‑15 (2004).

Further, Petitioner’s own records document that some of its staff members were aware that D.C. was at risk for elopement. In their written direct testimony, Petitioner’s administrator and its admissions coordinator aver that neither D.C.’s daughter nor staff employed by the facility from which D.C. transferred communicated to them that the resident displayed active exit-seeking behavior while residing at that facility. P. Ex. 1 ¶¶ 6, 9; P. Ex. 3 at ¶¶ 6, 8. Yet, even if the administrator and the admissions coordinator were unaware that D.C. posed an elopement risk, the staff members who completed D.C.’s admission summary and elopement risk assessment were aware of the risk. The admission summary notes that D.C.’s current diagnoses included dementia with behavioral disturbances. CMS Ex. 2 at 4. Moreover, Petitioner’s staff documented that she was at risk for elopement because she had previously resided in a locked dementia ward. Id. at 6. In addition, Petitioner’s staff completed an elopement risk assessment specifically documenting that D.C. had a history of wandering, had expressed a desire to leave the facility, and exhibited exit-seeking behaviors. Id. at 13. I therefore conclude that, at the time D.C. was admitted to Petitioner’s facility, Petitioner was aware that D.C. posed an elopement risk.

Not only was Petitioner aware that D.C. was at risk for elopement, Petitioner’s staff was also aware that D.C. was actively trying to exit the facility before she succeeded in eloping undetected. Progress notes from the afternoon and early evening of January 30, 2017, document that D.C. was “confused” and exhibited exit-seeking behavior. CMS Ex. 3 at 1. CNA E.T. discovered D.C. attempting to open an exit door at the end of a

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hallway. CMS Ex. 17 at 6; CMS Ex. 18 at ¶ 15; P. Ex. 5 at ¶ 6.Petitioner asserts that D.C. first attempted to elope between 6:15 p.m. and 6:30 p.m. P. MSD at 12. In her written direct testimony, CNA E.T. avers that she observed the Resident attempting to open the exit door between 6:15 p.m. and 6:20 p.m. P. Ex. 5 at ¶ 6. This testimony contradicts the time recorded in the progress notes and in the facility’s investigation report. Compare P. Ex. 5 at ¶ 6 with CMS Ex. 3 at 1, CMS Ex. 13 at 2. LPN L.M., the nurse who wrote the 5:30 p.m. progress note documenting that D.C. was actively attempting to exit the facility, also provided written direct testimony that, although she entered 5:30 p.m. in the note, D.C. actually attempted to elope at about 6:30 p.m. P. Ex. 6 at ¶ 6. Given the inconsistent reports regarding the time D.C. first attempted to exit the facility, I give greater weight to the progress notes recorded on the day in question and the statements collected during the facility’s investigation. I conclude that the earlier statements are more reliable because they were recorded closer in time to the events in question than statements written months later in preparation for litigation. Nevertheless, even if I were to accept that D.C. first attempted to elope between 6:15 and 6:30 p.m., I would not conclude that Petitioner substantially complied with Tag F323. While CNA E.T. was able to redirect D.C., preventing her from eloping at that time, the incident put Petitioner on notice that the resident was exhibiting exit-seeking behavior. In summary, on January 30, 2017, Petitioner knew D.C.’s diagnoses and its own staff assessed her as an elopement risk and observed her attempting to elope that same day. I therefore reject Petitioner’s argument that it could not have foreseen that D.C. might attempt to elope or that she might succeed in eloping undetected. Petitioner was therefore required to take all reasonable steps to prevent D.C. from doing so.

After D.C. attempted to elope, CNA E.T. left her alone in her room. P. Ex. 5 at ¶ 6. Administrator A.C. implemented 30-minute checks of D.C. when he left the facility, at or around 5:30 p.m.In his written direct testimony, Administrator A.C. stated that he initiated 30-minute checks as a precaution because D.C. was a new admission, and not because she had attempted to elope. CMS Ex. 18 at ¶ 20; P. Ex. 1 at ¶ 11. The 30-minute checks allowed D.C. to be unsupervised for approximately 30 minutes at a time after she had already attempted to elope once. As is apparent from the events of that day, this gave D.C. ample time to elope successfully, as it was only 10 minutes after her last check that she was reported missing. According to CNA E.T., D.C. “moved pretty fast compared to some of the other residents.” CMS Ex. 18 at ¶ 15; see also CMS Ex. 17 at 6. Accepting Petitioner’s argument that the 30‑minute checks were not initiated due to the attempted elopement (P. MSD at 11), Petitioner did not initiate any additional preventative measures to ensure D.C. did not again attempt to elope. For example, had Petitioner implemented one‑on‑one observation of D.C. immediately after she first attempted to elope, perhaps she would not have

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succeeded in eloping thereafter. Yet, Petitioner did not implement this measure until after D.C. eloped successfully.I draw this conclusion even though Petitioner’s ADON communicated to the DON that D.C. was in need of one-on-one supervision at about 6:36 p.m. See CMS Ex. 12. Despite this communication, nothing in the record suggests that such supervision was initiated before D.C. was reported missing at about 6:40 p.m. Indeed, ADON A.S. stated in her written direct testimony that one-on-one supervision “would have been implemented but for [D.C.’s] exit just prior to implementation.” P. Ex. 4 at ¶ 6; see also CMS Ex. 17 at 8 (Administrator A.C. told surveyor that, by the time staff began to implement one-on-one supervision, D.C. had eloped). There is no doubt D.C. was exposed to the risk of more than minimal harm by being outdoors without proper outerwear on a cold night in unfamiliar surroundings. Accordingly, Petitioner was not in substantial compliance with section 483.25(d).

Moreover, contrary to Petitioner’s second argument (P. MSD at 20-21), holding Petitioner responsible to provide adequate supervision for D.C. is not equivalent to holding Petitioner strictly liable for D.C.’s elopement. Appellate panels of the DAB have held that the concept of strict liability has no place in a regulatory enforcement action such as the present case. See, e.g., The Bridge at Rockwood, DAB No. 2954 at 23 (2019) (and cases cited therein). Rather, as the Rockwood panel explained, it is the regulations that establish the standards with which facilities must comply. Id. Consistent with this framework, I conclude that Petitioner did not comply substantially with section 483.25(d) because it failed to implement additional reasonable measures to mitigate the risks of harm D.C. faced when she eloped unobserved. Further, as I discuss in the following subsection, Petitioner also failed to take the reasonable step of ensuring its door alarm system properly triggered the alarm panels located at the nurses’ station. This failure similarly subjected D.C. and any other resident at risk of eloping to the risk of more than minimal harm.

2. Petitioner did not take all reasonable measures to prevent residents who were elopement risks from leaving the facility unobserved because it failed to ensure that its exit door alarms functioned properly.

CMS alleges that Petitioner failed to comply with the requirements of 42 C.F.R. § 483.25(d)(1) by failing to ensure the proper operation of its door alarm system. CMS Br. at 16-18. The survey revealed that the alarms at Petitioner’s exit doors did not provide adequate warning to staff if a resident attempted to elope. The surveyor’s investigation documented that, while the door through which D.C. exited was equipped with an audible alarm, staff could not hear the alarm except when relatively close to the exit door. CMS Ex. 1 at 6-7; CMS Ex. 18 at ¶¶ 15, 17, 18, 23. Importantly, the exit door alarm was not loud enough to hear at the nurses’ station or the other end of the building.

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CMS Ex. 18 at ¶ 15. In addition, the light panels at the nurses’ station did not illuminate to indicate when the door had been breached. CMS Ex. 1 at 7; see also CMS Ex. 18 at ¶ 25. At the time of the survey, a representative of a security alarm repair company with whom Petitioner contracted informed the surveyor that there were “missing switches that would allow the alarm to trigger at the nursing station panel.” CMS Ex. 1at 8; see also CMS Ex. 18 at ¶ 26.

Petitioner asserts that “all audible door alarms, including the audible alarm at the exit door through which [D.C.] eloped, were functioning properly at the time of [D.C.’s] single elopement.” P. MSD at 19. Petitioner further argues that the fact the alarm panels at the nurse’s station were not triggered “is immaterial” because the Resident would have eloped whether or not the door alarm was working properly. P. MSD at 17.

I do not find Petitioner’s defenses persuasive. First, as a factual matter, I am not convinced that the alarm system was operating properly. The alarm company representative told the surveyor that, at some point in the past, opening the doors would have triggered an alarm at the nurses’ station and the alarm panel at the northeast corner of the building. CMS Ex. 18 at ¶ 26. If the alarm system had been functioning properly, the staff at the nurses’ station would have been immediately alerted both that a resident was attempting to elope and of the location of the attempt. This information would enable staff to respond immediately to the appropriate door. Instead, Petitioner’s staff would only know a resident was attempting to elope if they happened to be within earshot of the alarming door. If staff were too far away to hear the alarm, no one would know a resident had eloped until someone noticed that a resident was missing. It is therefore not clear to me that D.C. would have eloped successfully or been able to elude staff’s efforts to find her outside the facility had the exit door alarms operated properly. I therefore do not agree that the failure of the exit doors to alarm at the nurses’ station is “immaterial” to D.C. eloping successfully.

Further, my finding that Petitioner did not comply substantially with its obligation to provide adequate supervision and assistive devices to prevent accidents does not depend solely on the fact that D.C. was able to elope successfully. Even if she had not eloped, Petitioner’s malfunctioning door alarm system would still have posed an unreasonable risk to any of Petitioner’s residents who might be at risk for elopement. Ensuring that the door alarm system was properly configured to notify staff at the nurses’ station that a resident was attempting to elope is one of several reasonable steps that Petitioner failed to take to prevent the risk of harm to its residents. And, as I have discussed above, Petitioner’s failure to take such reasonable steps posed the risk of more than minimal harm to any of its residents who might succeed in eloping unobserved. For all these reasons, Petitioner did not comply substantially with 42 C.F.R. § 483.25(d).

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2. CMS’s finding of immediate jeopardy is not subject to review.

CMS asserts that Petitioner’s noncompliance constituted a pattern of immediate jeopardy to resident health and safety (i.e., the “K” scope and severity level). CMS Br. at 19-20. CMS further asserts that the finding of immediate jeopardy is not subject to review in these proceedings because a successful challenge would not affect the range of CMP or change the finding of substandard quality of care. CMS Br. at 18-19. Petitioner argues that even if I were to find noncompliance, there is insufficient factual and legal justification for a finding of immediate jeopardy. P. PSD at 3‑12. Petitioner also asserts that CMS erred in prohibiting it from conducting its NATCEP because there was no substandard quality of care. Id.

CMS is correct: the regulations do not permit me to review CMS’s immediate jeopardy determination in this case.Moreover, were I authorized to consider CMS’s immediate jeopardy determination, I would not find that it was clearly erroneous for the reasons explained below in section IV.B.3 of this decision. I may review CMS’s scope and severity findings (including a finding of immediate jeopardy) only if: (1) a successful challenge would affect the range of the CMP; or (2) CMS has made a finding of substandard quality of care that results in the loss of approval of a facility’s NATCEP. 42 C.F.R. § 498.3(b)(14), (d)(10); see also Cedar Lake Nursing Home, DAB No. 2344 at 9 (2010); Evergreen Commons, DAB No. 2175 (2008), aff’g DAB CR1684 (2007); Aase Haugen Homes, DAB No. 2013 at 17‑19 (2006).

In the case of a per-instance CMP, the regulations provide for a single penalty range ($2,097 to $20,965)CMP amounts increased, effective February 3, 2017, for deficiencies occurring after November 2, 2015. See 82 Fed. Reg. at 9182. without regard to the level of noncompliance. 42 C.F.R. § 488.438(a)(2). Thus, the finding of immediate jeopardy does not affect the range of the CMP. See NMS Healthcare of Hagerstown, DAB No. 2603 at 6-7 (2014); see also Oaks of Mid City Nursing & Rehab. Ctr., DAB No. 2375 at 24 (2011). Similarly, CMS’s scope and severity finding does not affect approval of the facility’s NATCEP. Under the statute and regulations, the state agency cannot approve the program if CMS imposes a penalty of $10,483Likewise, the CMP dollar amount that triggers disapproval of a NATCEP was adjusted upward for 2017. 82 Fed. Reg. at 9188. or more; the facility loses its approval without regard to the immediate jeopardy finding, even if that finding constitutes substandard quality of care. Act § 1819(f)(2)(B); 42 C.F.R. § 483.151(b)(2)(iv); see Sunshine Haven Lordsburg, DAB

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No. 2456 at 3 (2012), aff’d in part, Sunshine Haven Nursing Operations, LLC v. U.S. Dep’t of Health & Human Servs., 742 F.3d 1239 (10th Cir. 2014). Under the statute and regulations, it is the dollar amount of the CMP, and not the level of noncompliance, that results in the loss of the facility’s NATCEP. Because the dollar amount of the CMP is above the threshold that triggers loss of NATCEP approval (and I affirm the amount of the CMP below), the absence of substandard quality of care would not restore Petitioner’s NATCEP. For these reasons, I have no basis to review CMS’s determination that Petitioner’s deficiencies posed immediate jeopardy to its residents.

3. A per-instance CMP of $18,812 is reasonable.

My authority to review the reasonableness of a CMP imposed by CMS is limited by 42 C.F.R. § 488.438(e). The limitations are: (1) I may not set the CMP at zero or reduce it to zero; (2) I may not review CMS’s exercise of discretion to impose a CMP; and (3) I may only consider the factors specified by 42 C.F.R. § 488.438(f) when determining the reasonableness of the CMP amount. The factors in section 488.438(f) include: (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. The absence of culpability is not a mitigating factor. The factors listed in § 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.

Unless a facility contends that a particular regulatory factor does not support the CMP amount, the administrative law judge must sustain it. Coquina Ctr., DAB No. 1860 at 32 (2002). My review of the reasonableness of the CMP is de novo and based upon the evidence in the record before me. I am not required to defer to CMS’s determination of the reasonable amount of the CMP to impose, but I may only consider the regulatory factors described above. My role is to determine whether the amount of any CMP imposed is “within reasonable bounds” considering the purpose of the Act and regulations. Emerald Oaks, DAB No. 1800 at 12 (2001); see also CarePlex of Silver Spring, DAB No. 1683 at 17 (1999). In this case, CMS imposed an $18,812 per-instance CMP, which is near the maximum per-instance CMP that CMS may impose.As previously explained, the maximum per-instance CMP amount for 2017 was $20,965. 82 Fed. Reg. 9182. 42 C.F.R. § 488.438(2); 45 C.F.R. § 102.3.

When CMS elects to impose a CMP, it sets the CMP amount based on, among other factors, the “seriousness” of the noncompliance. 42 C.F.R. §§ 488.404(a), (b),

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488.438(f). Seriousness is a function, at least in part, of the noncompliance’s scope and severity. 42 C.F.R. § 488.404(b). The most serious noncompliance is that which puts one or more residents in “immediate jeopardy.” 42 C.F.R. § 488.438(a) (authorizing the upper range of per-day CMPs for immediate-jeopardy-level noncompliance). “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.

Petitioner argues that the CMP imposed is not reasonable because the state agency recommended a CMP of $9,341 per day for one day of noncompliance and CMS unreasonably failed to adopt the state’s recommendation. P. PSD at 12-13. However, the state agency’s role is merely to recommend remedies. CMS has the final say. As an appellate panel of the DAB observed, “CMS’s finding of noncompliance and imposition of remedies . . . must take precedence over the state’s position. The statute and regulations contemplate the possibility that state and federal findings and choice of remedies may not always be in accord.” Lake Mary Health Care, DAB No. 2081 at 7 (2007). Therefore, I find no merit in Petitioner’s argument that the state agency’s recommendation should have controlled here.

Petitioner also argues that CMS could not impose a per-instance CMP because CMS did not consider all the factors enumerated in a 2014 CMS Survey & Certification Group (S&C) Memorandum addressing the CMP Analytic Tool and Submission of CMP Tool Cases. P. PSD at 15-20 (citing CMS S&C Memorandum, 15‑16-NHThe memorandum is available at https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-15-16.pdf (last visited November 8, 2019). A copy is in the record as P. Ex. 17.). However, as the memorandum states, the CMP Analytic Tool “is not intended to yield an automatic, immutable end result [nor does it] replace professional judgment or the application of other pertinent information in arriving at a final CMP amount.” P. Ex. 17 at 3. More importantly, CMS’s choice of remedies (i.e. whether to impose a per-day or per-instance CMP) is not an initial determination subject to appeal. 42 C.F.R. § 498.3(d)(11). The prohibition on review of CMS’s choice of remedies extends to the factors CMS or the state agency considered when selecting the remedy. 42 C.F.R. § 488.408(g)(2). In any event, I determine whether the CMP is reasonable de novo, meaning I make an independent assessment of the reasonableness of a CMP based upon the evidence and regulatory factors. 42 C.F.R. § 488.438(e). Thus, it is unnecessary for me to consider how CMS arrived at the amount of the CMP.

Having considered the regulatory factors, I find that the seriousness of Petitioner’s noncompliance in this case is sufficient to justify the amount of the CMP because the

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noncompliance placed D.C. at risk for serious injury, harm, impairment, or death.I conclude that the amount of the CMP is reasonable based on the seriousness of the deficiency alone. I do not rely on CMS’s contention that Petitioner had a poor compliance history. See CMS Br. at 20-21. See 42 C.F.R. § 488.438(a). As I have described above, D.C. was able to elope unobserved from Petitioner’s facility. On the night D.C. eloped, it was between 17 and 35 degrees Fahrenheit and she eloped without a coat or proper footwear. No staff at Petitioner’s facility knew D.C. had eloped until she could not be located. This occurred, at least in part, because the exit-door alarm system was not functioning properly in that it did not alert a panel at the nurses’ station that a door had been breached. While the door through which D.C. exited had a local alarm, the door was at the end of a hallway and the alarm could not be heard except by someone close by. A repair company determined that the door was missing switches to allow it to alert the panel at the nurses’ station.

It is apparent that an elderly resident, diagnosed with dementia, outdoors in an unfamiliar setting on a cold night would be exposed to risks of serious harm. D.C. might have become disoriented and wandered until she suffered hypothermia. She might have been struck by a car or fallen and injured herself. In addition, the inadequacy of Petitioner’s door alarm system put any resident who might elope at risk for similar harm. Fortunately for all concerned, no other resident eloped and a passerby discovered D.C. and took her to the police station within several minutes after she exited Petitioner’s facility, so these risks were averted. Nevertheless, the lucky circumstance that no one was injured does not diminish the seriousness of Petitioner’s noncompliance. I am not required to find that a resident experienced actual harm to conclude that a deficiency poses the likelihood of serious injury, harm, impairment, or death. See, e.g., Lakeport Skilled Nursing Ctr., DAB No. 2435 at 8 (2012). Therefore, I conclude, based on the facts, that the CMP imposed is reasonable in this case due to Petitioner’s serious noncompliance.

Finally, Petitioner argues that CMS’s selection of a per-instance CMP must be reversed because it was arbitrary and capricious. P. PSD at 20-21. The argument misunderstands my role as an administrative law judge in the administrative appeal process. The arbitrary and capricious standard, codified in Administrative Procedure Act (APA), is a standard for court review of final agency actions. 5 U.S.C. § 706. My role differs from that of a federal court reviewing final agency actions. In administrative proceedings governed by 42 C.F.R. Part 498, neither CMS’s determination to impose a CMP nor my decision reviewing that determination is a final agency action. See 42 C.F.R. § 498.90 (providing that the appellate decision of the DAB is the final agency action that may be appealed to federal court). As an appellate panel of the DAB held in Hanover Hill Health Care Ctr., “[n]othing in the APA . . . applies the ‘arbitrary and capricious standard’ to Board review of an ALJ decision on behalf of the Secretary . . . .” DAB No. 2507 at 7 (2013); see also Cal Turner Extended Care Pavilion, DAB No. 2030 at 7 (2006) (discussing “the distinction between the oversight role of a federal court reviewing

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agency decisions to determine if an adequate basis is articulated and the internal agency appeals process for formulating final agency action”). Thus, there is no merit to Petitioner’s argument that I am required to consider whether CMS’s actions were arbitrary and capricious.

V. Conclusion

For the reasons stated in this decision, I sustain CMS’s determinations. I conclude that Petitioner was not in substantial compliance with the participation requirements at 42 C.F.R. § 483.25(d) (Tag F323). I further find reasonable the $18,812 per-instance CMP imposed for Petitioner’s noncompliance.