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                              Copperas Cove LTC Partners, Inc. DAB No. 3049 (2021)
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Copperas Cove LTC Partners, Inc. DAB No. 3049 (2021)








  
  
    

  
      
Department of Health and Human Services 
    DEPARTMENTAL APPEALS BOARD
          Appellate Division





Copperas Cove LTC Partners, Inc. DAB No. 3049 (2021)
Docket No. A-18-117Decision No. 3049September 20, 2021

        
              
    

      FINAL DECISION ON REVIEW OF ADMINISTRATIVE LAW JUDGE DECISION

Copperas Cove LTC Partners, Inc. (Petitioner), a Texas skilled nursing facility (SNF) that participates in the Medicare program, has appealed the June 25, 2018 decision of an Administrative Law Judge (ALJ) upholding civil money penalties (CMPs) imposed on Petitioner by the Centers for Medicare & Medicaid Services (CMS) for violations of Medicare participation requirements in 42 C.F.R. Part 483.  *Copperas Cove LTC Partners, Inc.*, DAB CR5120 (ALJ Decision).  The ALJ determined that from October 13 through November 3, 2016, Petitioner was not in substantial compliance with participation requirements that:  (1) prohibit the use of chemical restraints imposed for purposes of convenience, and not required to treat medical symptoms; (2) prohibit involuntary seclusion; (3) require a SNF to develop and implement written policies that prohibit involuntary exclusion; and (4) require a SNF to have an emergency evacuation plan that addresses the needs of all residents.  The ALJ also sustained, as not clearly erroneous, CMS’s determination that Petitioner’s noncompliance with the latter three requirements placed one or more residents in “immediate jeopardy” from October 13 through October 15, 2016.  Finally, the ALJ held that the CMPs imposed by CMS – $11,641 per day for October 13, 14, and 15, 2016, and $2,053 per day from October 16 through November 3, 2016 – were reasonable in amount.

For the reasons explained below, we affirm the ALJ’s decision because it is supported by substantial evidence and free of legal error.

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Legal Background

To participate in the Medicare program, a SNF must be in “substantial compliance” with the requirements in 42 C.F.R. Part 483, subpart B.1
  42 C.F.R. § 483.1(b), 488.400.  Those participation requirements include meeting applicable standards of the Life Safety Code of the National Fire Protection Association.  *Id*. § 483.70(a) (Oct. 1, 2016).

A SNF is not in substantial compliance when it has a “deficiency” – that is, a failure to meet a Medicare participation requirement – that creates at least the potential for more than minimal harm to one or more residents.  *See i**d*. § 488.301 (defining “substantial compliance” as “a level of compliance with the requirements of participation such that any identified deficiencies pose no greater risk to resident health or safety than the potential for causing minimal harm”).  The term “noncompliance,” as used in the applicable regulations, is synonymous with lack of substantial compliance.  *Id*. (defining “noncompliance”).

Compliance with Medicare participation requirements is verified through onsite surveys performed by state health agencies.  *Id*. §§ 488.10, 488.11(a).  A state agency reports any “deficiency” (“failure to meet a participation requirement”) it finds in a Statement of Deficiencies.  *Id*. §§ 488.301 (defining “deficiency”), 488.325(f)(1).  A Statement of Deficiencies also indicates the survey agency’s assessment of the “seriousness” of any cited deficiency, including whether a deficiency constitutes lack of substantial compliance.  *See id*.§ 488.404(a).  Seriousness is a function of scope (whether a deficiency is “isolated,” constitutes a “pattern,” or is “widespread”) and severity (whether a deficiency has created a “potential for” only “minimal harm,” a potential for “more than minimal harm,” resulted in “[a]ctual harm,” or placed residents in “immediate jeopardy”).  *Id*.§ 488.404(b).  The most severe deficiency is that which puts one or more residents in immediate jeopardy.  *See id*. § 488.438(a) (authorizing the highest per-day CMPs for immediate-jeopardy-level noncompliance); *Woodland Oaks Healthcare Facility*, DAB No. 2355, at 2 (2010) (citing authorities).

CMS may impose enforcement “remedies” on a SNF that is found to be out of substantial compliance.  42 C.F.R. §§ 488.400, 488.402(b)-(c), 488.406.  The types of remedies that CMS may impose include a per-day CMP for the “number of days a facility is not in

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substantial compliance with one or more participation requirements.”  *Id*. § 488.430(a).  A per-day CMP must be imposed within the ranges specified by regulation:  an upper range for immediate-jeopardy-level noncompliance; and a lower range for noncompliance below the immediate-jeopardy level of severity.  *Id*. §§ 488.408(d)(1)(iii), 488.408(d)(3)(ii), 488.438(a)(1).  During October 2016 (when the compliance survey in this case was performed), the upper range was $6,291 to $20,628, and the lower range was $103 to $6,188.  *See id*. § 488.438(a)(1); 45 C.F.R. § 102.3 (table) (Oct. 1, 2016).  In selecting a CMP amount within the applicable dollar range, CMS considers the SNF’s history of noncompliance, financial condition, and degree of culpability, and the factors specified in section 488.404 (mainly, the seriousness of the noncompliance).  42 C.F.R. § 488.438(f).

A SNF may challenge the findings of noncompliance that led to imposition of a remedy by requesting an ALJ hearing and appealing any unfavorable ALJ decision to the Departmental Appeals Board (Board).  *Id*. §§ 488.408(g)(1), 498.3(b)(13), 498.5(b)-(c).  In cases where a SNF appeals a CMS determination of noncompliance that led to the imposition of a CMP, the scope of review is limited to considering whether a basis for imposing the CMP exists and whether the amount of the CMP is reasonable.  *See id*. § 488.438(e), (f); *Capitol Hill Cmty. Rehab. & Specialty Care Ctr.*, DAB No. 1629, at 2-3 (1997).

Case Background

From October 10 through October 16, 2016, the Texas Department of Aging and Disability Services (survey agency) performed two Medicare compliance surveys of Petitioner:  an annual recertification survey, and a life-safety survey.  CMS Ex. 2, at 1; CMS Ex. 3, at 1.  The surveys found 20 deficiencies (14 during the recertification survey, and six during the life-safety survey), but only four are at issue in this appeal, and all four relate (in whole or in part) to Petitioner’s care of Resident 5, a 35-year-old developmentally disabled male resident with cerebral palsy who had lived in Petitioner’s facility since 1988.2

The deficiencies at issue were cited and described by the survey agency in the Statements of Deficiencies under “tags” F222, F223, F226, and K048.  Under tag F222, the survey agency found that Petitioner had violated 42 C.F.R. § 483.13(a) by subjecting Resident 5 to a “chemical restraint” for the purpose of “discipline or convenience” and not to treat his “medical symptoms.”  CMS Ex. 3, at 5-6.  Under tag F223, the survey agency found that Petitioner had subjected Resident 5 to “involuntary seclusion” in violation of 42 C.F.R. §§ 483.13(b) and 483.13(c)(1)(i).  *Id*. at 18.  The survey agency further found,

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under tag F226, that Petitioner had violated 42 C.F.R. § 483.13(c) by failing to implement its policies and procedures for “abuse prevention.”  *Id*. at 38-39.  Finally, under tag K048, the survey agency found that Petitioner had violated Life Safety Code (LSC) Standard 19.7.1.1 – and thereby violated 42 C.F.R. § 483.70(a) – by not having a written emergency evacuation plan that addressed how one wheelchair-bound resident with special needs (Resident 5) and two bed-bound residents would be evacuated from the facility in the event of a fire or other emergency.  CMS Ex. 2, at 1, 9-10.

The survey agency further determined that:

The deficiencies cited under tags F222, F223, F226, and K048 constituted lack of substantial compliance with the cited participation requirements;
	The deficiencies cited under tag F222 and F223 caused actual harm to Resident 5;
	The deficiencies cited under tags F223, F226, and K048 placed one or more residents in immediate jeopardy from October 13 through October 15, 2016;
	After Petitioner abated the immediate jeopardy, Petitioner remained out of substantial compliance with 42 C.F.R. §§ 483.13(b) and 483.13(c), with LSC Standard 19.7.1.1, and with other participation requirements, at a lower level of severity;
	Petitioner returned to substantial compliance with all Medicare participation requirements as of November 4, 2016.3CMS Ex. 2, at 9-10, 16, 22; CMS Ex. 3, at 3, 18, 38, 59. 
CMS concurred with all of the survey agency’s noncompliance findings and, as remedies, imposed two CMPs:  a CMP of $11,641 per day for the period October 13 through October 15, 2016 (the period of immediate-jeopardy-level noncompliance), and a CMP of $2,053 per day for the period October 16 through November 3, 2016 (the period of noncompliance following abatement of the immediate jeopardy).  CMS Ex. 1, at 1, 9.

Petitioner requested a hearing to challenge CMS’s enforcement action, indicating that it disagreed with all of the deficiency citations from the October 2016 surveys.  *See*Dec. 19, 2016 Request for Hearing.  In accordance with the ALJ’s pre-hearing order, the parties exchanged documentary evidence and witness declarations that served as written direct testimony.

In its pre-hearing exchange, Petitioner asked the ALJ to subpoena the testimony of two managerial employees from the survey agency’s Austin Regional Office.  *See*Pet.’s Pre-Hearing Exch. at 2-3.  The ALJ denied the subpoena request following a conference call

Page 5

with the parties.  *See*Dec. 7, 2017 Order.

The ALJ later convened an in-person hearing for the purpose of allowing Petitioner to cross-examine Melissa Schwarz, one of the surveyors who participated in the October 2016 recertification survey.  After the hearing, the parties submitted post-hearing briefs.  In addition to arguing that CMS had failed to prove any lack of substantial compliance, Petitioner suggested in its post-hearing brief that CMS’s enforcement action should be barred under the doctrine of equitable estoppel.  Pet.’s Post-Hearing Br. at 5.

The ALJ’s decision addresses the deficiency citations alleging that Petitioner was noncompliant with sections 483.13(a), 483.13(b), 483.13(c), and LSC Standard 19.7.1.1 (the citations under survey tags F222, F223, F226, and K048, respectively).  ALJ Decision at 2.  The ALJ determined it was unnecessary to review the merits of other deficiency citations about which the parties had submitted argument and evidence because the noncompliance he found to exist “amply justif[ied]” the CMPs imposed.  *Id*.

The ALJ Decision

The ALJ began his analysis with the following description of Resident 5:

The resident [was] severely cognitively impaired and [was] totally dependent on caregivers for all of his activities of daily life.  His numerous diagnoses and medical issues include[d]:  cerebral palsy, hypothyroidism, encephalopathy, macular degeneration, contracture, aphasia, and convulsions.  Problems associated with these diagnoses include[d] attention deficit hyperactivity disorder and intellectual disabilities.  The resident [was] unable to walk.  He [could] ambulate by moving about on his knees and in a wheelchair.  The resident [was] unable to speak and [was] unable to comprehend instructions concerning his personal safety.

During the years of his residence at Petitioner’s facility, Resident #5 manifested numerous behavioral issues.  He wandered into other residents’ rooms.  On occasion he grabbed at other residents and or staff, pulling on their hair or touching them inappropriately.  He grabbed or pulled on objects inappropriately.  He made loud noises to express himself, and he resisted instruction or requests from staff.  He became aggressive at times and was agitated on occasion.

Clearly, Resident # 5 [was] an individual who can be at times extremely difficult to manage.  He posed at the very least a serious annoyance to other residents. . . .

ALJ Decision at 2-3 (record citations omitted).

Page 6

The ALJ determined that Petitioner, in trying to manage Resident 5’s behavior, failed to substantially comply with 42 C.F.R. § 483.13 in three respects.  First, the ALJ found that, between June 17, 2016 and the date of the survey, Petitioner administered Risperidone (an anti-psychotic drug) to Resident 5 for its “sedative effect,” and without a valid “clinical basis,” in violation of section 483.13(a).  ALJ Decision at 3, 4.  Second, the ALJ found that Petitioner violated Resident 5’s right under section 483.13(b) to be free from involuntary seclusion by locking him in his room – a room with an exit door that he could not open independently – for “extended periods.”  *Id*.at 3. And third, the ALJ found that Petitioner’s use of involuntary seclusion had violated section 483.13(c), which requires a SNF to develop and implement written policies prohibiting resident mistreatment, neglect, and abuse.  *Id*.at 5.  The ALJ also found that Petitioner had violated LSC Standard 19.7.1.1 (and thereby violated 42 C.F.R. § 483.70(a)) because its emergency preparedness plan “lacked specific guidance for [evacuating] residents, such as Resident # 5, who were helpless to protect themselves from an emergency such as a fire.”  *Id*. at 6, 10-11.  In addition, the ALJ upheld, as “not clearly erroneous,” CMS’s findings that the violations of sections 483.13(b) and 483.13(c) and LSC Standard 19.7.1.1 had placed residents in immediate jeopardy.  *Id*. at 6.

After concluding that CMS had a basis to impose the CMPs, the ALJ found that the penalty amounts – $11,641 per day for the period of immediate jeopardy, and $2,053 per day for the period of noncompliance below the immediate-jeopardy level of severity – were “reasonable” in light of the nature and seriousness of the noncompliance and Petitioner’s “culpability.”  *Id*. at 11.  The ALJ further found that Petitioner “had not challenged CMS’s determination regarding the duration of the noncompliance.”  *Id*. Finally, the ALJ rejected Petitioner’s contention that the doctrine of equitable estoppel barred the imposition of remedies.  *Id*.at 8.

Standard of Review

In general, Board review of an ALJ’s decision is limited to determining whether or not: (1) factual findings in the decision are supported by “substantial evidence” in the record as a whole; (2) the decision’s necessary legal conclusions are correct (that is, are consistent with applicable statutes and regulations); and (3) a “prejudicial error of procedure . . . was committed.”  *See Guidelines – Appellate Review of Decisions of Administrative Law Judges Affecting a Provider’s Participation in the Medicare and Medicaid Programs*(“*Board Guidelines*”), “Completion of the Review Process,” ¶ (c), (available at https://www.hhs.gov/about/agencies/dab/different-appeals-at-dab/appeals-to-board/guidelines/participation/index.html).

“Substantial evidence” means “such relevant evidence as a reasonable mind might accept as adequate to support a conclusion.”  *Richardson v. Perales*, 402 U.S. 389, 401 (1971) (quoting*Consol. Edison Co. v. NLRB*, 305 U.S. 197, 229 (1938)).  “The ‘substantial evidence’ standard is deferential.”  *Glenoaks Nursing Ctr.*, DAB No. 2522, at 6 (2013).

Page 7

“Under the substantial evidence standard, the Board does not re-weigh the evidence or overturn an ALJ’s choice between two fairly conflicting views of the evidence; instead, the Board determines whether the contested finding could have been made by a reasonable fact-finder tak[ing] into account whatever in the record fairly detracts from [the] weight of the evidence that the ALJ relied upon.”  *Douglas Bradley, M.D.*, DAB No. 2663, at 5 (2015) (internal quotation marks omitted); *see also**Golden Living Ctr. - Frankfort*, DAB No. 2296, at 9-10 (2009), *aff’d*, 656 F.3d 421 (6th Cir. 2011).

Analysis4

In its request for review, Petitioner challenges each of the ALJ’s noncompliance findings.  Req. for Review (RR) at 10-13, 14-15.  Petitioner also contends, contrary to what the ALJ concluded, that CMS’s immediate-jeopardy findings are clearly erroneous.  RR at 13-14, 15.  In addition, Petitioner contends that the ALJ improperly limited its cross-examination of Surveyor Schwarz, improperly rejected its claim of equitable estoppel, and wrongfully denied its pre-hearing request to subpoena testimony from employees in the survey agency’s Austin office.  RR at 5-8, 15.  Finally, Petitioner asserts that the CMPs imposed by CMS are unreasonable.  RR at 15.  (Petitioner does not appeal the ALJ’s decision not to address the merits of other deficiency citations from the October 2016 surveys.)

As discussed below, we conclude that the ALJ’s noncompliance findings are supported by substantial evidence.  In addition, we uphold the ALJ’s conclusion that CMS’s immediate-jeopardy findings are not clearly erroneous.  We also affirm the ALJ’s conclusion that the per-day CMPs imposed by CMS were reasonable.  Finally, we reject Petitioner’s contentions concerning the cross-examination of Surveyor Schwarz, its equitable estoppel defense, and the denial of its request for a subpoena.

**1.       *Substantial evidence supports the ALJ’s conclusion that Petitioner subjected Resident 5 to a chemical restraint in violation of 42 C.F.R. § 483.13(a).***

Section 483.13(a) states that a SNF resident “has the right to be free from any physical or chemical restraints imposed for purposes of discipline or convenience, and not required to treat the resident’s medical symptoms.”  42 C.F.R. § 483.13(a) (Oct. 1, 2016).5

Page 8

Section 483.13(a) implements section 1819(c)(1)(A)(ii) of the Social Security Act (Act), which similarly provides that a SNF “must protect and promote the right[ ] of each resident . . . to be free from . . . any physical or chemical restraints imposed for purposes of discipline or convenience and not required to treat the resident’s medical symptoms.”6
  Section 1819(c)(1)(A)(ii) further states that “[r]estraints may only be imposed . . . to ensure the physical safety of the resident or other residents, and . . . only upon the written order of a physician that specifies the duration and circumstances under which the restraints are to be used (except in emergency circumstances specified by the Secretary until such an order could reasonably be obtained).”  The limitations on restraints are elements of a SNF’s general obligation under Medicare law to ensure that residents achieve positive health outcomes.  *Cross Creek Health Care Ctr.*, DAB No. 1665, at 4 (1998) (citing section 1819(b)(2) of the Act); Act § 1819(b)(2) (“A skilled nursing facility must provide services to attain or maintain the highest practicable physical, mental, and psychosocial well-being of each resident.”).

Section 483.13(a) “imposes on nursing facilities, not doctors, an obligation to use restraints in a very prescribed manner – not for discipline, not for convenience and only if required by the resident’s medical symptoms.”  *Cross Creek*at 11.  A SNF may violate section 483.13(a) when it uses a physical or chemical restraint without first assessing the resident’s need for the restraint, considering the efficacy of “less restrictive alternatives to treat the resident’s symptoms,” and “weigh[ing] the risks of restraint application against the benefits.”  *Lakeridge Villa Health Care Ctr.*, DAB No. 1988, at 18 (2005), *aff’d*, 202 F.3d 903 (6th Cir. 2006).  A physician’s order for restraint use may be some evidence of medical necessity, but a SNF may not blindly or automatically defer to a physician’s judgment in this area; to the contrary, a SNF has “an independent obligation to ensure that the use of restraints, even with a doctor’s order, meets the criteria of the regulation.”  *Cross Creek*at 11.  In other words, a SNF “must be able to show with other evidence [besides a doctor’s order] as appropriate that the specific restraints applied were not imposed for discipline or convenience and were necessary to treat a medical symptom.”  *Id*.Improper restraint use has the potential for significant harm, including physical injury, mental or emotional anguish, and loss of dignity.  *See, e.g., Lakeridge Villa* at 16, 21 (upholding finding that improper use of restraints presents the potential for more than minimal harm); *Cross Creek*at 6 (noting that the “use of restraints is associated with numerous negative outcomes”); *Woodstock Care Ctr.*, DAB No. 1726, at 32 (2000) (“Excessive or improper use of intrusive methods of restraint impinges on residents’ dignity and well-being, and even when needed they can be emotionally and physically devastating.”), *aff’d,*363 F.3d 583 (6th Cir. 2003).

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To fully understand the ALJ’s reasons for concluding that Petitioner had used Risperidone to chemically restrain Resident 5, it is helpful to briefly review some undisputed background information about the drug, the reason it was prescribed for Resident 5, and the parties’ relevant contentions before the ALJ.

Risperidone (brand name Risperdal) is an “atypical antipsychotic” medication.7
  CMS Ex. 7, at 1.  According to its FDA labeling, Risperidone is “indicated” for treatment of schizophrenia, “acute manic or mixed episodes associated with Bipolar I Disorder,” and “irritability associated with autistic disorder.”  CMS Ex. 7, at 1, 3; CMS Ex. 3, at 8.  The labeling indicates that, for adults with the approved indications, the recommended daily dose ranges from 1.0 mg to 8.0 mg (depending on the indication), and that recommended titration (incremental dose adjustment) ranges from 0.5 mg to 2.0 mg per day.  CMS Ex. 7, at 1, 4-6.  The labeling further indicates that “sedation” was among the “most common adverse reactions” to the drug during clinical trials.  *Id*.at 1, 19, 22.

As early as December 2012, a form titled “Consent for Psychoactive Medication Therapy” reflected a plan to administer Risperidone to Resident 5 to treat “combative[ness]” and lack of “impulse control” with the goal of reducing “aggressive behavior.”  CMS Ex. 5, at 87.  The consent form noted that “[c]ommon and/or significant side effects or risks associated with” antipsychotic medication include “[s]edation.”  *Id*.

In October 2016, when the relevant surveys were performed, Resident 5’s plan of care indicated that Resident 5 was receiving Risperidone for “impaired cognitive function/dementia or impaired thought processes r/t [relating to] his intellectual disabilities dx [diagnosis].”  CMS Ex. 5, at 6.  The plan also indicated that Resident 5 “require[d]” Risperidone for “[b]ehavior management,” and that “behavior symptoms” targeted by the drug included “pacing, wandering, disrobing, inappropriate response to verbal communication, [and] violence/aggression toward staff/others.”  *Id*.at 7-8.

CMS argued before the ALJ that Petitioner violated 42 C.F.R. § 483.13(a) by carrying out a June 17, 2016 physician order to substantially increase Resident 5’s dose of Risperidone without questioning whether the order was clinically justified.  CMS’s Post-Hearing Br. at 11-15.  Petitioner responded that it had administered Risperidone to “treat Resident #5’s intellectual disabilities and inappropriate behavior” and not as an “unwarranted” chemical restraint.  *See* Pet.’s Post-Hearing Br. at 6, 8-9.

Finding support in the record for CMS’s contention and rejecting Petitioner’s contention, the ALJ made the following findings:

Page 10

Resident # 5 had been receiving Risperidone, an anti-psychotic medication, prior to June 17, 2016.  His dosage up until that date was 0.5 mg of the drug twice daily.  However, on or just prior to that date, his physician ordered that the resident’s dosage be increased to 2 mg twice daily, a four-fold increase in the medication.  The stated reasons for this sudden and very substantial dosage increase [according to records generated by Petitioner’s nursing staff] were:  “attention-deficit hyperactivity disorder, predominately inattentive type” and “unspecified intellectual deficiencies.”

Neither the [physician] order nor an assessment by Petitioner’s staff explained why a greatly increased dose of this anti-psychotic medication was warranted at th[at] time.  Nothing in the resident’s treatment record suggests that his behavior had changed in the days leading up to June 17.  The month before Petitioner increased the dosage, progress notes indicate that “[s]ince admission [in 1988], Resident continues to be the same . . . .”  As I have discussed, the resident had lived at Petitioner’s facility for nearly 28 years prior to June 17, 2016, and his behaviors were well noted and consistent.  No evidence suggests a sudden deterioration as of that date.  On June 17 the resident was observed being aggressive and agitated, making loud noises, and pulling other residents’ hair.  This behavior, while certainly disruptive, did not constitute a change in the resident’s condition.

Nor was there a clinical basis for administration of a substantially increased dosage of Risperidone.  The resident did not have a diagnosed condition that suggested that administration of this drug was appropriate.  Risperidone is generally used to treat schizophrenia and bipolar disorder.  It is not generally used to treat attention deficit disorder and certainly not to treat “unspecified intellectual deficiencies.”

Furthermore, although there may be certain conditions for which it would be appropriate for Petitioner’s staff to administer 2 mg of Risperidone twice daily to a resident, there is no evidence that Petitioner assessed Resident # 5’s need for a significantly increased daily dosage of Risperidone.  There is no evidence that Petitioner assessed Resident # 5 to specifically need 2 mg of Risperidone twice daily.

What was the reason for Petitioner to administer such a high dose of Risperidone to Resident # 5 [beginning in June 2016]?  I infer the answer to that question from the resident’s clinical record and from what the resident’s physician told surveyors when asked about his prescribing the drug to Resident # 5.  The original stated bases for administering Risperidone to the resident [as noted in a plan of care] included “behavior management.”  A consent form indicated Resident # 5 was being treated

Page 11

with Risperidone for the conditions of “combative” and “impulse control.”  The resident’s physician stated [in a survey interview] that the purpose of increasing the dosage [in June 2016] was to treat “restlessness.”  Thus, administering a high dosage of the drug was a form of chemical restraint. . . .

I infer . . . that the administration of Risperidone in a greatly increased dose had the effect of sedating Resident # 5.  Surveyors noted that the resident was often in bed and apparently asleep, particularly in late afternoons.  They observed the resident to manifest a flat affect.  Resident # 5’s mother noticed a change in the resident’s demeanor, finding that he appeared to be drugged.

ALJ Decision at 3-5 (footnote and record citations omitted).  The ALJ found that Petitioner’s use of a 2.0 mg twice-daily dose of Risperidone “to restrain [Resident 5] chemically” may have “freed Petitioner’s staff and other residents from the problems created by Resident # 5’s behavior,” but rendered him “a subdued prisoner, deprived of any opportunity to enjoy life.”  *See id*. at 6.

On their face, these findings support the ALJ’s conclusion that Petitioner was not in substantial compliance with 42 C.F.R. § 483.13(a).  As noted, that regulation prohibits a SNF from administering medication that restrains a resident unless doing so is required to treat the resident’s “medical symptoms” and is not for discipline or convenience (that is, to make a resident’s behavior more manageable).  *Cf. Woodstock Care Ctr.*, DAB No. 1726, at 38 (“Over-medication for the purpose of making residents tractable for the convenience of the facility is indeed barred by the restrictions on chemical restraints . . .”).  The ALJ found that Petitioner violated section 483.13(a) by giving Resident 5 a four-fold increase of Risperidone that subdued and sedated him, caused him to have a flat affect, and altered his demeanor to the point that he appeared drugged, even though the dose was not required to treat symptoms of a diagnosed medical condition.  ALJ Decision at 4-6.

Petitioner does not dispute that it chemically restrained Resident 5 by giving him a 2.0 mg twice-daily dose of Risperidone.  However, Petitioner contends that the chemical restraint did not violate section 483.13(a) because Resident 5’s “medical symptoms” warranted administration of that dose.  RR at 10 (asserting that Risperidone was not an “*unwarranted*chemical restraint” (italics added)).  However, substantial evidence supports the ALJ’s finding that the 2.0 mg twice-daily dose was not required medical treatment for Resident 5.  According to a nursing record confirming the physician’s June 17, 2016 order, the clinical reasons for the increased dose were Resident 5’s “unspecified intellectual dis[abilities]” and attention-deficit hyperactivity disorder (ADHD), “predominantly inattentive type.”  CMS Ex. 5, at 50.  However, neither “intellectual disabilities” nor ADHD is an FDA-approved indication for the use of Risperidone (CMS

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Ex. 7, at 1, 3), and the nursing staff’s records do not specify what symptoms associated with those conditions the increased dose was meant to treat or alleviate (CMS Ex. 5, at 50)*.*

Petitioner’s records include a form, titled “Doctor’s Rounds,” on which Resident 5’s physician entered notes (dated June 17, 2016) indicating that he had increased the Risperidone dose because Resident 5 was “restless.”  CMS Ex. 5, at 49.  No further explanation for the change appears on that form.  In a survey interview, the physician confirmed that he had increased the dose to treat “restlessness,” not for ADHD, and that Risperidone is used to treat that symptom in patients with cerebral palsy.  CMS Ex. 3, at 13.  However, there is no evidence corroborating the physician’s suggestion that Risperidone is appropriate treatment for “restlessness” in cerebral palsy patients, and Petitioner does not contend that the increased dose was justified on that ground.8
  In addition, the physician admitted (in the survey interview) that he “should not have  increased the [Risperidone] that much” (from 0.5 mg twice-daily to 2.0 mg twice-daily) because Resident 5 was a “small guy.”  CMS Ex. 3, at 12-13; *see also* Tr. at 52.9
  The physician also acknowledged that Risperidone posed a risk of serious harm to Resident 5, stating that the drug could “make [Resident 5] sleepy, have a flat affect, and even kill him.”  CMS Ex. 3, at 13 (quoting the physician’s survey interview statement).

As noted, Resident 5’s plan of care indicates, and Petitioner admits, that it administered Risperidone to Resident 5 to address certain “behaviors,” such as wandering and aggression.  CMS Ex. 5, at 8.  However, none of those behaviors is identified in Resident 5’s clinical records as a symptom of a diagnosed medical condition for which Risperidone is appropriately prescribed.  Assuming for argument’s sake that Risperidone was appropriate treatment for the targeted behaviors, there was no documented need to *quadruple* the dose on June 17, 2016, for that purpose.  As the ALJ noted, Resident 5’s clinical records do not show that the targeted behaviors had worsened or become more frequent in the previous weeks and months, or were posing a risk of harm to himself or others that could not be adequately mitigated by other interventions, such as redirection, increased supervision, or administration of Ativan, a drug that Petitioner says its staff administered to quell “agitation” and “aggression.”  *See, e.g.*, CMS Ex. 5, at 53 (nursing note entry on June 17, 2016 at 10:41 showing administration of Ativan in response to very aggressive and agitated behavior with “good results”—before Risperidone was

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increased); *id*. at 66-67, 69-70, 75-76 (behavior monitoring records for March, April, and June 2016 showing no worsening or frequent behavioral issues); *id*. at 4, 8 (indicating that staff administered Ativan, a benzodiazepine, to Resident 5 for “anxiety” and “breakthrough seizures and agitation” associated with a diagnosis of “unspecified convulsions”); CMS Ex. 3, at 9 (survey finding that Resident 5’s clinical records for March, April, and June 2016 “revealed no documentation of behavioral issues” such as “aggression, agitation, or combativeness”); *see also*RR at 9 (stating that “agitation” and “aggression” was “typically treated with Ativan” and “occasionally” with Risperidone).10
  Resident 5’s clinical records also reflect no statement by his physician or any other medical professional justifying the magnitude of the dose increase or specifying the expected therapeutic benefits from administering a twice-daily dose four times higher than the one Resident 5 had been receiving prior to June 17, 2016.

Despite the meager clinical rationale for the physician’s June 17, 2016 order, Petitioner carried out the order without verifying its medical necessity and assessing its potential impact.  Resident 5’s clinical records reveal no attempt by Petitioner’s staff to question the physician about the order, a step that Petitioner’s director of nursing thought should have been taken under the circumstances.  *See*CMS Ex. 3, at 13 (noting that the director of nursing indicated in her survey interview that “her expectation would be for her nursing staff to have questioned Physician A [Resident 5’s physician] for the Risperdal being increased that much and all at once . . . when the order was received”); CMS Ex. 36 (Schwarz Decl.), at 5 (testifying about the director of nursing’s interview statements); CMS Ex. 3, at 13 (noting that Resident 5’s physician told surveyors that Petitioner’s staff “did not question the significant dose increase” he ordered on June 17, 2016).  Nor do those records show that Petitioner at any point weighed the benefits and risks to Resident 5 of a 2.0 mg twice-daily dose of Risperidone or consulted with the physician to determine the circumstances under which it would have been appropriate or required to reduce that dose.  Petitioner’s failure to independently assess Resident 5’s need for the increased dose and its potential impact on his well-being, coupled with the uncontested evidence that Petitioner used Risperidone for “behavior management” (CMS Ex. 5, at 8), supports the ALJ’s finding that the increased dosage of Risperidone beginning in June 2016 was for the convenience of its staff – that is, to help staff manage Resident 5 and not to treat medical symptoms – in violation of section 483.13(a).

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Three other circumstances further support the ALJ’s conclusion that Petitioner was not in substantial compliance with section 483.13(a).  First, although the statute underlying the regulation provides that a restraint “may only be imposed . . . to ensure the physical safety of the resident or other residents” (Act § 1819(c)(1)(A)(ii)(I)), there is nothing in Resident 5’s clinical records indicating that, as of June 17, 2016, an increased dose of Risperidone was necessary for that purpose.  Petitioner does not point to evidence that other measures (besides chemical restraint) being taken at that time were inadequate or ineffective to ensure resident safety.

Second, Petitioner carried out the June 17, 2016 order – an order that effectively resulted in a chemical restraint – even though it did not meet the condition in section 1819(c)(1)(A)(ii) of the Act, which states that a restraint may be used “only upon the written order of a physician that *specifies the duration and circumstances* under which the restraints are to be used” (italics added).  The June 17, 2016 order did not meet that statutory requirement because it did not indicate how long the increased dose of Risperidone should be administered, specify clinical circumstances for administering that dose, or specify criteria for determining whether or when to continue, reduce, or discontinue the medication.  Resident 5’s records show no attempt by the facility to obtain that information from the physician.

Third, Petitioner failed to follow its own relevant resident care policies in connection with the administration of Risperidone to Resident 5.  The Board has held that a SNF’s written policies “may reflect [the] facility’s own judgment about how best to achieve compliance [with a participation requirement] and hence failure to comply with [such] policies can support a finding that the facility did not achieve compliance with the regulatory standard.”*Bivins Mem’l Nursing Home*, DAB No. 2771, at 9 (2017).  Petitioner had two relevant policies in place during 2016.  The first, titled “Use of Restraints,” states that a chemical or physical restraint “shall only be used for the safety and well-being of the resident[ ] and only after other alternatives have been tried unsuccessfully.”11
  CMS Ex. 30, at 2; CMS Ex. 3, at 15-16.  A second policy, titled “Antipsychotic Drug Use,” states that antipsychotic medication should not be used unless the resident’s medical record “clearly indicates” that the resident has one of the “specific conditions” listed therein.12
  CMS Ex. 30, at 4; CMS Ex. 3, at 16-17.  The Antipsychotic

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Drug Use policy further requires the nursing staff to document “expected outcomes” from the use of antipsychotic medication so that the “attending physician can determine if the medications are working effectively,” and also requires the attending physician to “evaluate and document conclusions about the effectiveness of the medication and the need to continue or adjust the current dosage, or to discontinue or change the medication.”  CMS Ex. 30, at 4.

The records of Resident 5’s care do not show compliance with these policies and procedures.  For example, they do not show – and none of Petitioner’s witnesses testified – that Resident 5 had one of the “specific conditions” listed in the Antipsychotic Drug Use policy for using antipsychotic medication.  Resident 5’s records also do not show that the physician increased Resident 5’s Risperidone dose for his “safety and well-being.”  As noted, there is no documented safety rationale for the physician’s June 17, 2016 order or any contemporaneous determination by the physician or Petitioner’s staff that increasing the dose from 0.5 mg twice-daily to 2.0 mg twice-daily would enhance Resident 5’s overall well-being.  The only documented reasons for the dose increase were conditions or symptoms – ADHD, “intellectual disabilities,” and restlessness related to cerebral palsy – which are not among the specific conditions listed in Petitioner’s Antipsychotic Drug Use policy.  *See* CMS Ex. 30, at 4-5.

Also missing from Resident 5’s records is any indication that Petitioner carried out the June 17, 2016 order only after “other alternatives” for achieving the order’s purposes (whatever they were) had been considered and tried.  Finally, clinical records from the period between June 17, 2016 and the October 2016 survey do not show “expected outcomes” (to the extent any had been identified) from administering a 2.0 mg twice-daily dose of Risperidone or show that Petitioner’s staff obtained from the physician an evaluation of Risperidone’s effectiveness, its impact on Resident 5’s health and quality of life, and the continued need (if any) for the medication.

Petitioner contends, as it did before the ALJ, that Risperidone was appropriate treatment for Resident 5’s “aggressive” and “dangerous” behavior.  RR at 3, 9, 10-11.  According to Petitioner, Resident 5 “clearly exhibited *psychotic features*[by which Petitioner evidently meant “behaviors”] which warranted use of an antipsychotic medication such as Risperdal.”  RRat 11 (italics added).  To support that contention, Petitioner cites nursing progress notes and other clinical records documenting Resident 5’s behavior both before and after the survey.  RR at 9, 11 (citing the “Aggressive Behavior Record” in Exhibit B to Petitioner’s request for review).13
  Petitioner also relies upon the written

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direct testimony of Pearl Merritt, Ed.D., a registered nurse with a master’s degree in nursing, a background in long-term care, and a doctorate in education.  *Id*.(citing P. Ex. 5, at 3-8).

Petitioner complains that the ALJ wholly disregarded the testimony of Nurse Merritt concerning this and other compliance issues.  RR at 10-11.  That is inaccurate.  The ALJ considered Nurse Merritt’s testimony but found it “not credible” because she lacked “first-hand knowledge of what transpired at Petitioner’s facility,” did not “actually observe[]” Resident 5 or “consult[] with” his physician, and did not “participate[] in staff assessments of the resident’s condition.”  ALJ Decision at 10.  The ALJ also found that Nurse Merritt had “offer[ed] conclusions based on unattributed sources” or made “bald statements of fact without supporting documentation.”  *Id*.(The ALJ discounted the testimony of Petitioner’s other witnesses for the same reasons.  *Id*.)

In general, the Board “will defer to an ALJ’s findings on weight and credibility of witness testimony (oral or written) unless there are ‘compelling’ reasons not to do so.” *Nightingale Home Healthcare, Inc.*, DAB No. 2784, at 10 (2017) (some internal quotation marks omitted).  Petitioner does not assert any reason, much less a compelling one, to disregard the ALJ’s assessment of Nurse Merritt’s testimony.

The ALJ’s reasons for discounting Nurse Merritt’s testimony were well founded.  Nurse Merritt stated that Petitioner’s records reflect behaviors by Resident 5 that she characterized as “psychotic” or as manifestations of “psychosis,” including hitting, grabbing, and pulling the hair of staff and residents, inappropriate touching of other residents, “significant physical aggression towards staff and residents,” making loud sounds, refusing care and redirection, extreme agitation, and wandering into other residents rooms.  P. Ex. 5, at 2, 4-5, 6, 8.  However, Nurse Merritt, who is not a psychologist, psychiatrist, or medical doctor, cited no medical authority or contemporaneous clinical findings to support her characterization of Resident 5’s behaviors as “psychotic.”  The only diagnosed conditions linked to the June 17, 2016 order were ADHD and “intellectual disabilities.”  CMS Ex. 5, at 5, 6.  Petitioner has not offered any evidence that psychotic behavior is a symptom or feature of either of those conditions.

Nurse Merritt off-handedly asserted that Resident 5 had a diagnosis of “psychosis” (P. Ex. 5, at 4), implying that Risperidone was properly administered to treat *that*condition and any related symptoms or behaviors.  As proof that Resident 5 had a diagnosis of psychosis, Petitioner cites to its Exhibit 4, which is a copy of Resident 5’s “Admission Record.”  *See*RR at 2 (citing P. Ex. 4, at 2).  That copy of the Admission Record indicates that Petitioner had a diagnosis of “unspecified psychosis not due to a substance or known physiological condition” – but also indicates that the diagnosis was added to Resident 5’s clinical records on October 30, 2016, approximately *two weeks after* the survey agency completed its recertification survey of Petitioner.  *See*CMS Ex. 3, at 1

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(indicating survey completion on October 16, 2016).  The copy of the Admission Record obtained by the survey agency *during the survey* shows no diagnosis of “psychosis.”  CMS Ex. 5, at 1-2.  That is consistent with a Minimum Data Set (MDS) completed on October 5, 2016, which indicates that Resident 5 had no “active diagnosis” of psychosis or any other psychiatric disorder.  *Id*. at 29, 48.

Petitioner does not indicate what prompted the addition of the “unspecified psychosis” diagnosis to Resident 5’s Admission Record on October 31, 2016.  There is no evidence that it stems from a clinical evaluation of Resident 5 by a physician or psychiatrist.   Furthermore, Petitioner has not offered testimonial or documentary evidence, such as medical literature or accepted clinical practice standards, demonstrating that Risperidone is appropriate medical treatment for an individual with a diagnosis of “unspecified psychosis.”  Given these circumstances, the appearance of that diagnosis on Petitioner’s copy of Resident 5’s Admission Record does not contravene the ALJ’s finding that Petitioner’s administration of a 2.0 mg twice-daily dose of Risperidone was not required or appropriate medical treatment for Resident 5.
Petitioner points to Nurse Merritt’s statement that a 2.0 mg twice-daily dose of Risperidone is “within a therapeutic range for someone in Resident #5’s condition and with his behaviors/challenges.”  P. Ex. 5, at 7 (cited in RR at 10).  Again, Nurse Merritt cited no facts, data, studies, evidence-based treatment guidelines, or clinical findings (by Resident 5’s caregivers) to support her opinion.14
  *Id*.  She indicated that it was based on her “experience” but does not say what that experience is.  *Id*.  Furthermore, no medical practitioner involved in Resident 5’s care provided evidence that he needed a 2.0 mg twice-daily dose of Risperidone to treat any medical symptoms.  Indeed, even the physician that initially ordered the increased dose of Risperidone for Resident 5 subsequently acknowledged that the increased amount was too much.  CMS Ex. 3, at 12-13; Tr. at 52.

Petitioner’s other contentions do not persuade us that the ALJ improperly resolved the chemical-restraint issue.  Citing notes written by Resident 5’s physician on the Doctor’s Rounds sheet, Petitioner asserts that the physician properly increased Resident 5’s Risperidone dose “in an attempt to decrease Ativan,” and that the physician took this action because Risperidone “has fewer side effects than Ativan, and has less of a lethargic/sedative effect.”  RR at 9 (citing CMS Ex. 5, at 49).  The ALJ reasonably rejected that contention, accurately observing that while the cited notes reflect the

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physician’s decision to increase Resident 5’s Risperidone dose, they nowhere indicate that the physician took that action to reduce the resident’s Ativan intake.  CMS Ex. 5, at 4, 49.  And Petitioner cites no evidence that the physician ordered staff to reduce its use of Ativan for Resident 5.15

Petitioner further contends that “Resident #5’s medical records . . . support use of Risperdal at the ordered levels” (2.0 mg twice daily) because its pharmacy consultant monitored the administration of that drug on a monthly basis and indicated on its Gradual Dose Reduction Tracking (GDR) reports that the drug was being administered to treat bipolar disorder and ADHD; because the pharmacy consultant did not recommend any change in the daily dose for July, August, or September 2016; and because “medical records confirm” that Resident 5’s physician “likewise elected to continue” the 2.0 mg twice daily dose “until the surveyors insisted otherwise.”  RR at 11 (citing P. Ex. 1, at 1-3, 10, 17).

This line of argument rests on unsupported assumptions that Resident 5 had been diagnosed with bipolar disorder by a physician and that Risperidone was appropriately prescribed to treat his ADHD.  Apart from the GDR reports, none of Resident 5’s clinical records – including the MDS, plan of care, and nursing and physician notes and reports – indicate that Resident 5 had been diagnosed with bipolar disorder or was receiving treatment for symptoms associated with that disorder.  *See*ALJ Decision at 4 n.3 (and record citations in the footnote); *see also*Tr. at 50, 82 (testimony of surveyor).  Petitioner does not acknowledge this discrepancy between the GDR reports and the rest of Resident 5’s clinical records.  As the ALJ correctly observed, there is no evidence that Resident 5 was diagnosed with bipolar disorder by any psychiatrist or psychologist.  ALJ Decision at 4 n.3 (citing P. Ex. 4, at 2; CMS Ex. 5, at 29, 87.)  We find no error in the ALJ’s determination that there is “no clinical assessment justifying” the reference to bipolar disorder in Resident 5’s GDR tracking report (P. Ex. 1, at 1).  *Id*.  As for Resident 5’s ADHD, the other condition noted in the GDR reports, it is not an approved indication for Risperidone (CMS Ex. 7, at 1; Tr. at 53), and Petitioner offered no evidence that Risperidone is properly administered as off-label treatment (that is, treatment for a purpose other than that for which the drug received FDA approval) for ADHD.  Moreover, Resident 5’s treating physician admitted that Risperidone was not administered to Resident 5 to treat ADHD and, in any event, he had increased the dosage too much.  CMS Ex. 3, at 12-13; Tr. at 52.

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Furthermore, any action or inaction by the pharmacy consultant did not relieve Petitioner of its obligation under 42 C.F.R. § 483.13(a) to independently assess whether administration of Risperidone at the ordered level was required to treat Resident 5’s medical symptoms or ensure his safety (and that of other residents) – an assessment that Petitioner did not make at any point prior to the October 2016 survey.  For the same reason, it makes no difference to the outcome that Resident 5’s physician may have renewed or extended the June 17, 2016 order at some later time.  In fact, there is no evidence that, at any point between June 2016 and the date of the survey, Resident 5’s physician decided to continue Resident 5’s 2.0 mg twice-daily dose after assessing its efficacy and impact on Resident 5’s health and well-being.  Indeed, it was only when the treating physician was questioned about the prescribed amount at the time of the survey that he acknowledged that the four-fold increase of Risperidone had been too much.  CMS Ex. 3, at 12-13; Tr. at 52.
                         
Petitioner notes that, during the October 2016 survey, the physician reduced Resident 5’s Risperidone dose.  RR at 11.  Petitioner asserts that this dose reduction – which was from 2.0 mg twice daily to 0.5 mg twice daily (*see*P. Ex. 1, at 13; P. Ex. 4, at 38) – “was harmful” to both Resident 5 and other residents because Resident 5’s “aggressive behaviors escalated to the point where other residents verbalized outright fear” of him, and that his physician was, therefore, forced to re-increase the drug dosage by November 2016.”16
  RR at 11 (citing P. Ex. 4, at 3-4, 12; P. Ex. 5; and the summary of clinical records in Exhibit B to the request for review).

Petitioner is implying here the October 2016 dose reduction, followed by the alleged escalation in “aggressive behaviors,” demonstrate that a 2.0 mg twice-daily dose of Risperidone was effective in managing Resident 5’s dangerous behavior, and that its staff therefore acted reasonably in carrying out the order to administer that dose.  We have no doubt that sedating a resident with high doses of Risperidone will stop all sorts of undesirable behavior.  But, Petitioner presented no evidence that Resident 5’s physician ordered the increased dose of Risperidone as a necessary chemical restraint to manage Resident 5’s “aggressive behaviors.”  Moreover, Petitioner overlooks the fact that the regulations guarantee residents the right to be free from chemical restraints imposed for convenience, “and not required to treat the resident’s medical symptoms.”  42 C.F.R. § 483.13(a) (Oct. 1, 2016).  As discussed, Petitioner failed to establish that the 2.0 mg twice-daily dose of Risperidone – which indisputably restrained Resident 5 – was required to treat Resident 5’s medical symptoms and not merely for staff convenience.

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Still further, before using a chemical restraint, the facility must first verify that such use meets the regulatory criteria.  *Lakeridge Villa* at 17; *Cross* *Creek* at 10-11 (holding that a facility has an independent obligation to verify the regulatory criteria for restraint use are satisfied).  Petitioner produced no evidence that it did that before carrying out the June 17, 2016 order to increase Resident 5’s Risperidone dose from 0.5 mg twice daily to 2.0 mg twice daily.  More specifically, Petitioner produced no evidence that its staff verified that the four-fold increase was clinically appropriate, weighed the increased dose’s risks and benefits, considered the availability of less restrictive alternatives, or determined how the chemical restraint would help ensure Resident 5’s safety and meet his other assessed needs.  *See* *Lakeridge Villa* at 18 (holding that a facility cannot impose a restraint without assessing the need for it, considering the efficacy of “less restrictive alternatives to treat the resident’s symptoms,” and “weigh[ing] the risks of restraint application against the benefits”).  Indeed, Petitioner’s director of nursing confirmed that there was no behavioral assessment of Resident 5 at that time, and staff did not question the four-fold increase in the dosage before it was administered.  CMS Ex. 3, at 12-13.

For all the reasons discussed above, we find the ALJ’s conclusion that Petitioner was not in substantial compliance with 42 C.F.R. § 483.13(a) is supported by substantial evidence and not legally erroneous.

**2.       *Substantial evidence supports the ALJ’s conclusion that Petitioner involuntarily secluded Resident 5 in violation of 42 C.F.R. § 483.13(b).***

Section 483.13(b) states that a resident has the right to be free from, among other things, “involuntary seclusion.”  42 C.F.R. § 483.13(b) (Oct. 1, 2016).  At the time of the survey, Petitioner’s Use of Restraints policy defined “seclusion” as “placement of a resident alone in a room” and prohibited its use “unless *short-term monitored separation* [was] necessary because the resident exhibit[ed] combative or aggressive behavior that pose[d] a threat to the resident or other residents/staff in the facility.”  CMS Ex. 30, at 2-3 (italics added).

The ALJ concluded that Petitioner had violated section 483.13(b) by “locking [Resident 5] in his room for extended periods of time” during which he was “often deprived . . . of stimuli” such as toys or television.  ALJ Decision at 3.  The ALJ rejected Petitioner’s contention that placing Resident 5 in his room was necessary to calm him when he became “overstimulated,” noting that the contention was “undermined” by instructions in Resident 5’s plan of care to engage him in activities involving “cognitive stimulation” and “social interaction.”  *Id*. at 8 (citing CMS Ex. 5, at 6, 11) (internal quotation marks omitted).  In addition, the ALJ found that Petitioner had “offer[ed] no credible evidence” that it had configured Resident 5’s room with doors that he could not open as a way to prevent him from injuring himself or others, or that these features were a “necessary element of [his] care.”  *Id*. at 9-10.  In addition, the ALJ rejected Petitioner’s suggestion that, in “confining” Resident 5, Petitioner had “merely carr[ied] out the

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wishes” of his guardian (his mother), stating that Petitioner had offered “absolutely no proof that the guardian . . . ever requested that [Resident 5] be isolated as he was.”  *Id*. at 10.  Finally, the ALJ held that Petitioner’s seclusion of Resident 5 could not be considered lawful under section 483.13(b) even if it “fulfilled the express desires of [Resident 5’s] mother.”  *Id*.at 7, 10.

Substantial evidence supports the ALJ’s conclusion that Petitioner did not substantially comply with its obligation to protect Resident 5’s right to be free from involuntary seclusion.  Surveyor Schwarz testified that:

Resident 5’s room had an exit door with a “child safety cover . . . over the doorknob on the interior side of the door preventing Resident #5 from being able to open his door and leave the room independently.”  CMS Ex. 36 (Schwarz Decl.), at 6, 7.
	The room’s closet and bathroom doors had locking mechanisms that prevented those doors from opening.  *Id*. at 7.
	Petitioner’s MDS Coordinator stated during a survey interview that Resident 5 could not leave his room or get access to his wheelchair in the bathroom because of the doorknob safety cover and locks that were in place.  *Id*.
	Other members of Petitioner’s nursing staff reported, during their survey interviews, that Resident 5 was placed in his room after meals, when staff were “behind on showers,” or “to be able to assist . . . other residents and care for their needs.”  Tr. at 73; *see also*CMS Ex. 36 (Schwarz Decl.), at 9-10 (stating that a certified nursing assistant (“CNA F”) reported that Resident 5 was “taken to his room when the staff [were] behind on showers or if call lights need[ed] to be answered”); CMS Ex. 34 (Schroeder Decl.), at 2-3 (testifying that another certified nursing assistant (“CNA D”) reported that Resident 5 was “left in his room until last so that the staff could complete showers for other residents and get them out of bed and ready for mealtime because he would pull other residents hair and remove their bibs”).
	On multiple occasions during the survey (at 3:46 p.m. and 5:49 p.m. on October 10; at 6:20 p.m. on October 11; and at 3:22 p.m. and 4:34 p.m. on October 12), Resident 5 was observed in his room with the exit door closed, unable to leave because of the door’s child-safety mechanism.  CMS Ex. 36 (Schwarz Decl.), at 7-9.
	Resident 5’s mother stated during a survey interview that she believed that “‘staff were leaving [her son] in his room and drugging him so they did not have to messPage 22

with him,’” and that she usually found Resident 5 in his room when she visited.  *Id*.at 8.
	Petitioner’s isolation of Resident 5 “created . . . loss of dignity and psychosocial harm.”  *Id*. at 10.This testimony clearly establishes that Petitioner’s staff secluded Resident 5 in his room and precluded his exit.  It also shows that staff often did so for a reason other than to promote his health and safety – namely, to allow staff to attend to other residents.

In its request for review, Petitioner does not dispute that it routinely locked Resident 5 in his room for “extended periods” without access to toys or other stimuli (as the ALJ found).  Nor does it deny that this practice caused, or at least had the potential to cause, more than minimal harm to Resident 5.  Instead, Petitioner suggests (as it did before the ALJ) that it placed Resident 5 in his room *only*for therapeutic and safety reasons when he became “aggressive” or “agitated,” and that his room was the “least restrictive environment possible to treat his underlying medical conditions/disease pathology.”  RR at 12.

There is some evidence that Petitioner’s staff placed Resident 5 in his room when he became agitated or engaged in aggressive behavior – such as pulling other residents’ hair – and could not be “redirected” or calmed with medication.  CMS Ex. 36 (Schwarz Decl.), at 5 (testifying about survey interview statements of “CNA E” and “CNA F”); CMS Ex. 35 (Austin Decl.), at 3 (testifying that a licensed vocational nurse reported in a survey interview that staff would try to redirect Resident 5 when he engaged in certain unspecified behaviors but would bring him to his room if he could not be redirected); P. Ex. 6 (Beaver Aff.), at 3 (“The resident was removed from stimuli causing adverse reactions such as agitation or aggressive acting out; and was relocated to his room for calm and quiet.”).  However, the fact that staff secluded Resident 5 in those circumstances does not contradict CMS’s evidence that staff secluded him *on other occasions* for its convenience, so that it could meet the needs of other residents without having to monitor him.  Furthermore, Petitioner did not submit evidence that, when Resident 5 was placed in his room after exhibiting agitated or aggressive behavior, the nursing staff adhered to its written policy requiring that seclusion be only “short-term monitored separation,” a requirement intended to ensure that a resident’s isolation be no longer than necessary to achieve a therapeutic objective and institute alternative measures to meet the resident’s health and safety needs.  CMS Ex. 30, at 2.

Petitioner reiterates in the request for review that Resident 5 was secluded to prevent “over-stimulation” or “sensory overload.”  RR at 5, 12.  The ALJ reasonably rejected that claim as unsupported.  Petitioner’s plan of care for Resident 5 (as it existed during the October 2016 survey) does not identify sensory overload or over-stimulation as a health or safety problem requiring isolation or any other type of intervention.  *See*CMS Ex. 5, at

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6-14.  If anything, the plan of care implies that Resident 5 needed more stimulation:  it “[e]ncourage[d] staff to assist resident to engage in activities for socialization and stimulation,” *id*. at 6, because he was “dependent on staff for activities, cognitive stimulation, [and] social interaction,” *id*. at 11.

As evidence for its suggestion that Resident 5 was isolated only for therapeutic or safety reasons, Petitioner cites the written testimony of Nurse Merritt, Heather Beaver (Petitioner’s administrator at the time of the survey), Joshua Henderson (an employee of the company that owns Petitioner and other long-term care facilities), and Yvonne Fortson, R.N. (another employee of Petitioner’s corporate owner).  *See*RR at 12 (citing P. Ex. 5, at 4-8; P. Ex. 6, at 2-3; P. Ex. 7, at 2-9; P. Ex. 8, at 2-9); Pet.’s Pre-Hearing Exch. at 2.  As noted in the previous section, the ALJ found these witnesses “not credible” (*see*ALJ Decision at 10), and Petitioner offers no reason to disturb that credibility finding.  Furthermore, none of Petitioner’s witnesses explicitly contradicted Surveyor Schwarz’s testimony that Petitioner’s staff routinely secluded Resident 5 so that they could attend to other residents.

Petitioner makes two additional points that merit only brief discussion.  First, it asserts that “medical records and staff statements” do not show that Resident 5’s “room configuration” – in particular, the fact that the doors had child-safety mechanisms that prevented him from getting to his wheelchair and leaving the room on his own – constituted “‘involuntary seclusion’ for *disciplinary* purposes.”  RR at 12 (italics added).  This assertion reveals no error by the ALJ because the ALJ did not find that Petitioner secluded Resident 5 for disciplinary reasons (as punishment), or that the physical “configuration” of Resident 5’s room was itself a violation of section 483.13(b).

Second, Petitioner reiterates that placing Resident 5 in his room could not properly be considered involuntary seclusion (for purposes of section 483.13(b)) because that room was “configured as it was” at the “specific request” of Resident 5’s “family and guardian.”  RR at 12.  In support of that assertion, Petitioner cites testimony by its administrator that “during . . . guardianship proceedings,” Resident 5’s mother “worked with a judge and regulatory [sic] to be able retain and implement non-standard equipment in Resident #5’s room,” such as a doorknob safety cover that would “deter [him] from leaving the room to wander the halls independently due to his complete lack of safety awareness.”  P. Ex. 6 (Beaver Decl.), at 2 (cited in RR at 12).

The ALJ gave no weight to the administrator’s testimony because Petitioner offered no documentation “show[ing] that the staff ever assessed [Resident 5]’s needs and made a clinical judgment that configuring [his] room with locked doors and without stimuli of any sort was a necessary element of [his] care.”  ALJ Decision at 10.  The ALJ also noted that Petitioner had proffered no “official documents” (such as a court order) “suggesting that Resident # 5’s mother or Petitioner had obtained official permission to lock up” the

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resident, and no “statement from [Resident 5’s] mother suggesting that confining . . . the resident fulfilled any request that she’d made.”  *Id*. at 7.

We defer to the ALJ’s assessment of the administrator’s testimony, and Petitioner does not offer a compelling reason to do otherwise.  Petitioner does not contest the ALJ’s first two stated reasons for discounting that testimony – the absence of a clinical assessment by staff concerning the room “configuration,” and the failure to produce “official documents.”  *See*RR at 12.  Petitioner takes issue only with the ALJ’s third reason:   Petitioner contends it was improper for the ALJ to insist on corroborating testimony from Resident 5’s mother because she “refused to provide a written declaration” and was “not a witness under [its] control in any way,” and because “there was no way to compel a statement/testimony from [her] because DAB rules do not allow for conventional ‘discovery.’”  RR at 4 n.3.  These are hardly compelling reasons to reject the ALJ’s analysis.  While it is true that the applicable administrative appeal regulations do not authorize the type of discovery available in judicial proceedings, the regulations do authorize an ALJ to subpoena witness testimony, including testimony from third parties (such as Resident 5’s mother).  42 C.F.R. § 498.58.  We see no indication that Petitioner sought to subpoena testimony from Resident 5’s mother in connection with the ALJ hearing.

Moreover, the administrator’s testimony that Resident 5’s guardian obtained court approval to install child-safety locks, even if true, is immaterial.  The testimony is immaterial because the basis for CMS’s determination that Petitioner was noncompliant with section 483.13(b) was Petitioner’s *practice of routinely secluding* Resident 5 in his room in order to attend to the needs of other residents – not the mere *presence of* *child-safety locks* on the room’s doors.  *See*CMS Post-Hearing Br. at 8-9.  Any court approval to install those locks did not relieve Petitioner of its obligation under section 483.13(b) not to use the room in a way that would deny Resident 5 his right to be free from involuntary seclusion.  The ALJ correctly recognized that it was *Petitioner’s*obligation to make its *own*“clinical judgment” about the proper use of a room so equipped – a judgment for which there is no evidence in Resident 5’s clinical records.

Finally, we reject, as the ALJ did (ALJ Decision at 10), any suggestion that Resident 5’s guardian authorized the deficient nursing practice at issue here.  There is no evidence that the guardian authorized the staff’s involuntary seclusion of Resident 5 for extended periods (and without visual or tactile stimuli) so that it could attend to other residents.  Nor is there evidence that any request by the guardian about how to equip Resident 5’s room included explicit directions about when, for how long, or in what circumstances the room should be used to seclude Resident 5.  And, to the extent that involuntary seclusion was being used by Petitioner as a form of restraint, Petitioner’s own policies make clear that a resident’s guardian cannot authorize the unlawful use of restraints.  CMS Ex. 30, at 3 (“The surrogate/sponsor may not give permission to use restraints for the sake of

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discipline or staff convenience or when the restraint is not necessary to treat the resident’s medical symptoms.”).

For the reasons stated above, we find the ALJ’s conclusion that Petitioner was not in substantial compliance with 42 C.F.R. § 483.13(b) is supported by substantial evidence and not legally erroneous.**3.**       ***The ALJ’s conclusion that Petitioner violated 42 C.F.R. § 483.13(c) is supported by substantial evidence and not legally erroneous.***

Section 483.13(c) states, in relevant part, that a SNF “must develop and implement written policies and procedures that prohibit mistreatment, neglect, and abuseof residents . . . .”  42 C.F.R. § 483.13(c) (Oct. 1, 2016).  A subpart of this regulation specifies, among other things, that a SNF “must [n]ot use . . . involuntary seclusion.”  *Id*. § 483.13(c)(1)(i).

Before the ALJ, CMS contended that Petitioner was not in substantial compliance with section 483.13(c) because it involuntarily secluded Resident 5 in violation of the instruction in its Use of Restraints policy that seclusion not be used “unless short-term monitored separation becomes necessary because the resident exhibits combative or aggressive behavior that poses a threat to the resident or other residents/staff in the facility.”  CMS Post-Hearing Br. at 10 (quoting CMS Ex. 30, at 2).  CMS stated that Petitioner’s failure to follow this instruction was a failure to “implement” a policy prohibiting “abuse” of residents.  *Id*.  The ALJ agreed that the evidence demonstrated Petitioner’s noncompliance with 42 C.F.R. § 483.13(c).  ALJ Decision at 5.

In this appeal, Petitioner argues (as it did before the ALJ) that it was not cited for “abuse,” so it “could not possibly [be] in violation [of section 483.13(c)] for failing to implement abuse prevention policies.”  RR at 13; *see also* Pet.’s Post-Hearing Br. at 10-11.  We reject Petitioner’s contention and hold that Petitioner’s policy regarding seclusion was a policy prohibiting “abuse” within the meaning of section 483.13(c).  As defined in the applicable regulations, the term “abuse” includes the infliction of “unreasonable confinement.”  42 C.F.R. § 488.301 (Oct. 1, 2016) (defining abuse as the “willful infliction of injury, unreasonable confinement, intimidation, or punishment with resulting physical harm, pain or mental anguish”); *see also* Online Merriam-Webster Dictionary, defining the verb “confine” to mean “to hold within a location” or to “keep within limits” (https://www.merriam-webster.com/dictionary/confine).  Petitioner’s policy prohibiting “seclusion” (defined by the policy as “placement of a resident alone in a room”) except as a short-term measure to achieve valid health or safety objectives is a

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policy prohibiting unreasonable confinement – and hence a policy prohibiting abuse.17
  Moreover, there is uncontested evidence in the record that the involuntary seclusion of Resident 5 caused, or had the potential to cause, mental anguish to Resident 5.  *See*CMS Ex. 36 (Schwarz Decl.), at 10 (asserting that Resident 5’s involuntary seclusion “created a social isolation, loss of dignity and psychosocial harm”).

Our holding is consistent with the subparagraphs of section 483.13(c), which specify requirements that a SNF must meet through policy development and implementation.  Subparagraph (1)(i) states that a SNF must “[n]ot use verbal, mental, sexual, or physical abuse, corporal punishment, *or involuntary seclusion*.”  42 C.F.R. § 483.13(c)(1)(i) (Oct. 1, 2016) (emphasis added).  The specification of involuntary seclusion in subparagraph 1(i) makes clear that the types of written policies that section 483.13(c) requires a SNF to “develop and implement” include policies, such as Petitioner’s Use of Restraints policy, that prohibit involuntary seclusion.  Our holding is also consistent with Petitioner’s general “Resident Abuse Policy,” which indicates in its opening two paragraphs that it is designed to ensure that residents are free from various “abuses,” including “involuntary seclusion.”  CMS Ex. 30, at 7.

Petitioner further argues that it “had [the] required policies” in place during the relevant period; that it had an “aggressive staff training program regarding prevention of abuse, neglect, exploitation, and related topics”; and that CMS “offered no evidence that the facility’s policies here were *not* implemented.”  RR at 13 (italics in original).  Implicit in these assertions is the notion that a SNF meets its obligation to “implement” a policy prohibiting mistreatment, neglect, and abuse so long as it has trained or educated its staff about the policy.  We reject that proposition.  Although staff education and training are elements of policy implementation, the Board has held that a SNF is not in substantial compliance with section 483.13(c) to implement a policy prohibiting mistreatment, neglect, or abuse of residents if it does not follow or carry out such policies in caring for residents.  *See, e.g.*, *38-40 Freneau Ave. Operating Co.*, DAB No. 3008, at 2, 8 (2020) (citing Board decisions); *Life Care Ctr. of Gwinnett*, DAB No. 2240, at 6 (2009) (noting that “[p]rocedures which are not carried out in practice are worthless”).

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As our discussion in the previous section shows, Petitioner did not meet its obligation under section 483.13(c) because its staff routinely subjected Resident 5 to involuntary seclusion for the convenience of its staff (a form of resident mistreatment or abuse), in violation of its written policy that involuntary seclusion be used only as a short-term measure to reduce the risk of harm posed by a resident’s combative or aggressive behavior.  Furthermore, CMS proffered evidence, not rebutted by Petitioner, that its failure to follow its policy regarding involuntary seclusion caused Resident 5 significant harm (social isolation, loss of dignity, and psychosocial harm).  *See*CMS Ex. 36 (Schwarz Decl.), at 10.

Petitioner asserts that CMS could not properly use survey tag F226 to cite a violation of section 483.13(c) based on improper use of involuntary seclusion because “[t]here are tags/citations [presumably, tag F223, used to identify violations of section 483.13(b)] pertaining to improper use of restraints, but F226 is not among them.”18
  RR at 13.  We understand Petitioner to be arguing that CMS was prohibited from citing it for noncompliance with any participation requirement other than section 483.13(b) based on the evidence concerning the staff’s practice of secluding Resident 5.  However, CMS is not precluded from determining that a deficient resident-care practice violated more than one participation requirement.*Azalea Court*, DAB No. 2352, at 12 (2010) (holding that CMS could rely on the same set of facts to cite the facility for violations under two different survey tags), *aff’d*, 482 F. App’x 460 (11th Cir. 2012).  Furthermore, contrary to Petitioner’s implication, survey tags do not create any limitations on CMS’s enforcement authority or discretion.  They are merely reference numbers used by CMS to present interpretive guidance to state surveyors and by surveyors to collect and organize a survey’s evidence and findings.  *Golden Living Ctr. – Mountain View*, DAB No. 2953, at 3 n.6 (2019) (noting that survey tags are a “tool for organizing the surveyor findings on the SOD [Statement of Deficiencies]”), *rev’d and remanded on other grounds*, 832 F. App’x 967 (6th Cir. 2020).

Based on the foregoing, we find the ALJ’s conclusion that Petitioner was not in substantial compliance with 42 C.F.R. § 483.13(c) is supported by substantial evidence and not legally erroneous.

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**4.       *Substantial evidence supports the ALJ’s conclusion that Petitioner was not in substantial compliance with Life Safety Code Standard 19.7.1.1 and 42 C.F.R.******§ 483.70(a)(1)(i).***

Section 483.70 generally provides that a “facility must be designed, constructed, equipped, and maintained to protect the health and safety of residents, personnel and the public.”  42 C.F.R. § 483.70 (Oct. 1, 2016).  In connection with this requirement, and with certain exceptions not relevant here, a SNF must meet applicable provisions of the Life Safety Code (LSC) published by the National Fire Protection Association.  *See id*. § 483.70(a)(1)(i) (Oct. 1, 2016); *see also* *BGI Retirement, LLC*, DAB No. 2620, at 1-2 (2015).  LSC Standard 19.7.1.1 states in relevant part:

The administration of every health care occupancy shall have, in effect and available to all supervisory personnel, written copies of a plan for the protection of all persons in the event of fire, for their evacuation to areas of refuge, and for their evacuation from the building when necessary. . . .

CMS Ex. 2, at 11.

The ALJ concluded that Petitioner was not in substantial compliance with LSC Standard 19.7.1.1 because its Emergency Preparedness Plan (EPP) “lacked specific guidance for [evacuating] residents, such as Resident # 5, who were helpless to protect themselves from an emergency such as a fire.”  ALJ Decision at 6 (citing CMS Ex. 2, at 9-22; CMS Ex. 32, at 38).  According to the ALJ, there was nothing in the EPP that “addressed how to evacuate a resident – like Resident # 5 – who did not comprehend or follow instructions, who was likely to be obstructive or highly agitated during an emergency, or who, alternatively, might be non-responsive due to being administered high doses of Risperidone.”  *Id*.  The ALJ also noted that, although the EPP indicated that “special needs residents” would be specifically identified in Appendix B, the appendix did not list Resident 5 or any other resident having special needs.  *Id*.In addition, the ALJ found that the EPP “failed to address the specific needs” of Petitioner’s bed-bound residents.  *Id*.

The ALJ correctly found the EPP was, by its own terms, incomplete.  The EPP stated that  special needs residents – whom the plan defined as residents who were “PASRR positive upon admission and having an intellectual disability”19
 – would be “identified” in “Appendix B,” and that persons so “identified” would “be assisted and escorted to the evacuation assembly area designated within the plan” and “supervised . . . until evacuated due to their poor safety awareness.”  CMS Ex. 32, at 38.  A resident’s order of evacuation

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would depend on their mode of transportation, which was also to be specified in Appendix B.  *Id*.  Petitioner was required to update daily the list of special needs residents and their respective mode of transportation.  *Id*.

Appendix B, however, did not include a section identifying Petitioner’s special needs residents, who numbered 15 at the time of the survey (including Resident 5).  *See id*.at 7-8, 37-38, 80-87; CMS Ex. 2, at 11, 17; CMS Ex. 5, at 9 (indicating that Resident 5 was “PASRR Positive for Intellectual Disability”).  The EPP required that special needs residents be “identified” in Appendix B to ensure that facility staff knew which residents would require special assistance and supervision in an emergency evacuation, the mode of transportation required for their evacuation (*i.e.*, wheelchair or other assistive device), and the order of evacuation.  By not identifying the special needs residents who needed the assistance and supervision called for by the plan, the EPP failed to provide for the “protection” of those residents, in violation of the requirement in LSC Standard 19.7.1.1 that the plan protect “all” residents.  Petitioner cannot claim to have a written “plan” for the evacuation of a special needs resident, like Resident 5, when the plan itself failed to identify Resident 5 (or any other resident) as requiring special assistance.  As the ALJ found, this failure of the plan to address the needs of all residents created a risk of serious harm.  ALJ Decision at 6 (concluding that the consequences of lacking a specific plan for the emergency evacuation of Resident 5 and other special needs residents “very likely would have been lethal”).  For these reasons, we conclude there is substantial evidence in the record to support the ALJ’s conclusion that Petitioner was not in substantial compliance with LSC Standard 19.7.1.1 and 42 C.F.R. § 483.70(a)(1)(i) at the time of the October 2016 survey.20

Petitioner submits in its request for review that it “had an evacuation plan in place” on the date of the survey.  RR at 14.  This contention ignores the compliance allegations presented by CMS and resolved by the ALJ.  The issue was not whether Petitioner failed to have *any* evacuation plan, but whether its plan addressed the needs of all residents, particularly those who were, by virtue of their inability to look after their own safety, especially vulnerable in a fire emergency.  Petitioner does not challenge the ALJ’s finding that the EPP was incomplete or otherwise failed to provide the protection special-needs and bed-bound residents require.21
  Nor does Petitioner dispute the ALJ’s

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conclusion that these shortcomings violated LSC Standard 19.7.1.1.

Petitioner, however, asserts that Resident 5 “did not require any assistance different than any other non-ambulatory resident who could not self-evacuate.”  RR at 14.  Petitioner cites no facts or evidence to support that statement.  Moreover, the ALJ reasonably found that Resident 5’s documented behaviors (such as agitation and resistance to instruction) might pose challenges different from other “non-ambulatory” residents without intellectual disabilities.  In any event, the problem with the EPP, as the ALJ found, is that it did not identify Resident 5 as a person who could not self-evacuate, an omission that posed the very serious risk that he would not receive the assistance he needed during an emergency.

Citing the affidavit of Joshua Henderson, Petitioner further asserts that “at no time between 2014 and the [October 2016 survey] were life safety issues ever raised with respect to the configuration of Resident #5’s room,” and that there was “no immediate threat to Resident #5 as a result of his room’s configuration.”  RR at 15 (citing P. Ex. 7, at 11).  This contention reflects a misunderstanding of the basis for the ALJ’s noncompliance finding.  The ALJ did not find that physical features of Resident 5’s room violated the Life Safety Code (although they might have).  Rather, the ALJ found Petitioner noncompliant with the Life Safety Code because, among other things, its evacuation plan did not adequately address the needs of Resident 5 (or even identify Resident 5 as having special needs), regardless of his room configuration.

Finally, Petitioner suggests that the ALJ’s noncompliance finding should be overturned because the ALJ “wrongfully denied [its] request to subpoena the [survey agency’s] life safety program manager who had specifically approved Petitioner’s evacuation plans over the last two decades.”  RR at 15.  First, the allegation that Petitioner was not previously cited by the state survey agency for violating LSC Standard 19.7.1.1, even if true, is irrelevant in deciding whether the facility was noncompliant at the time of the October 2016 survey.  The ALJ considered this argument and correctly rejected it.  ALJ Decision at 8 (“A facility may not excuse unlawful behavior by arguing that it had gotten away with it for a long time nor may it obtain a pass from compliance requirements by asserting that state surveyors may have overlooked its noncompliance in the past.”); *see also* *Batavia Nursing & Convalescent Inn*, DAB No. 1911, at 33 (2004) (rejecting facility’s contention that CMS “waived” the right to cite a deficiency based on a condition that had existed at the facility for 25 years), 143 F. App’x 664 (6th Cir. 2005).

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Still further, the record shows no error by the ALJ in rejecting Petitioner’s subpoena request.22
  Under 42 C.F.R. § 498.58, a subpoena request must specify the “pertinent” facts that the party expects to establish with a witness’s testimony and “indicate why those facts could not be established without use of a subpoena.”  42 C.F.R. § 498.58(c)(3).  Petitioner’s subpoena request did neither of these things.  *See*Pet.’s Pre-Hearing Exch. (June 2, 2017) at 2-3, 4-5.  Petitioner explained that the survey agency program managers were not cooperative but did not explain what pertinent facts it intended to establish through their testimony or why those facts could not be established through other witnesses or documents.23

Moreover, any testimony by a survey agency employee regarding his or her views about the facility’s alleged prior compliance with LSC Standard 19.7.1.1 would have no bearing in this case.  CMS, not the survey agency, decides whether a facility is in substantial compliance.  *See*42 C.F.R. § 488.330(a)(1)(i)(C); *see also* *Avon Nursing Home*, DAB No. 2830, at 14 (2017) (“CMS makes its own determination of noncompliance, and decides what enforcement action to take, based on the survey’s findings.”).  Still further, “determinations of compliance by state agencies are not binding on the ALJ, who is charged with making a de novo determination based on the record before him as to whether the facility was in substantial compliance with the requirements in the federal regulations.”  *Ridgecrest Healthcare*, DAB No. 2598, at 11 (2014). 
Based on the foregoing, we find the ALJ’s conclusion that Petitioner was not in substantial compliance with LSC Standard 19.7.1.1 and 42 C.F.R. § 483.70(a)(1)(i) is supported by substantial evidence and not legally erroneous.

**5.       *The ALJ did not abuse his discretion in connection with Petitioner’s cross-examination of Surveyor Schwarz.***

Petitioner asserts that during the February 7, 2018 hearing, the ALJ committed an “abuse of discretion” – and thereby deprived it of a “fair and impartial hearing” – by “refusing to allow [its] counsel to question [Surveyor Melissa] Schwarz about her limited experience actually working in a long-term care facility, and her reasons for leaving that facility[.]”  RR at 8-9.  According to Petitioner, the ALJ “wrongfully allowed [Schwarz] herself to

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urge a relevance objection (regarding why [she] left her previous job in long term care), which the ALJ incorrectly sustained.”  *Id*.  Petitioner asserts that this action by the ALJ “deprived [it] of potentially significant evidence which would have gone straight to the heart of [Surveyor] Schwarz’s credibility . . . [and] could have a direct bearing on whether her testimony should be believed in this case over the testimony of [Petitioner’s witnesses].”  *Id*. at 9.

CMS responds that the ALJ allowed Petitioner to question Schwarz about her education, training, and experience and “did not ‘sustain’ or ‘disallow’ further questioning of the witness regarding qualifications.”  Response Br. at 14.  CMS further contends that although the ALJ at one point “cautioned” (CMS’s term) Petitioner’s lawyer that extensive exploration of the witness’s background would be unproductive if material facts were not in dispute, the ALJ’s cautionary statements were not an abuse of discretion and did not deprive Petitioner of its right to a fair and impartial hearing.  *Id*. at 15.

We preliminarily note that Petitioner did not complain at the hearing or in its post-hearing brief that its cross-examination of Schwarz had been improperly curtailed.  Nor did Petitioner tell the ALJ what additional information she expected or wanted to elicit from further questioning about Surveyor Schwarz’s background.  Petitioner therefore failed to preserve the cross-examination issue for appellate review by the Board.  *Cf. Board Guidelines,* “Completion of the Review Process, ¶ (a) (stating that the Board “will not consider issues . . . which could have been presented to the ALJ but were not”); Fed. R. Evid. 103(a)(2) (providing that a party “may claim error in a ruling to . . . exclude evidence only if the error affects a substantial right of the party and . . . [the] party informs the court of its substance by an offer of proof, unless the substance was apparent from the context”); *id*., Notes of Advisory Committee on Proposed Rules (indicating that the purpose of the offer-of-proof requirement is to call to the judge’s attention the “nature of the error . . . so as to alert him to the proper course of action and enable opposing counsel to take proper corrective measures”); *Columbus Nursing & Rehab. Ctr.*, DAB No. 2247, at 23 n.10 (2009) (indicating that although the Board is not subject to the Federal Rules of Evidence, it “often looks to them for helpful guidance in considering evidentiary issues”); *United States v. Clements*, 73 F.3d 1330, 1336 (5th Cir. 1996) (holding that “this circuit will not even consider the propriety of the decision to exclude” evidence “if no offer of proof was made at trial”); *Merrill v. Southern Methodist Univ.*, 806 F.2d 600, 609-10 (5th Cir. 1986) (applying the offer-of-proof rule to reject a claim that a trial court had improperly prevented cross-examination of a witness).

Even if that issue had been preserved, we find no error or abuse of discretion by the ALJ in connection with the cross-examination of Surveyor Schwarz.  “[T]he conduct of the hearing rests generally in the ALJ’s discretion.”  *Carrington Place of Muscatine*, DAB No. 2321, at 22 (2010).  That principle extends to the limitations and ground rules ALJs may establish for cross-examination.  *See id*.  More specifically, an ALJ “has discretion to limit the scope of cross-examination where the result does not substantively impair the

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ability to decide the issue presented on a full, fair record.” *Vitas Healthcare Corp. of Cal.*, DAB No. 1782, at 22 (2001) (citing *Cent. Freight Lines, Inc. v. United States*, 669 F.2d 1063, 1068 (5th Cir. 1982)); *see also*5 U.S.C. § 556(d) (mandating, in proceedings governed by the Administrative Procedure Act, “such cross-examination as may be required for a full and true disclosure of the facts”).  The Board will vacate or modify an ALJ’s decision based on an allegedly improper evidentiary or procedural ruling “only if the appellant demonstrates that the ruling was prejudicial.”  *Carrington Place* at 22-23 (noting that the facility “failed to explain with any specificity how the ALJ’s” limitations on cross-examination “impaired its ability to litigate specific issues material to the outcome of the proceeding”); *Royal Manor*, DAB No. 1990, at 4 (2005) (noting that “[w]hen the Board finds a procedural error, the Board will reverse or remand only if the procedural error was prejudicial”); *Board Guidelines*, “Completion of the Review Process,” ¶ (c)(indicating that the possible bases for modifying or reversing a decision by the Administrative Law Judge include a “*prejudicial* error of procedure (including an abuse of discretion under the law or applicable regulations)” (italics added)).

The hearing transcript discloses no error or abuse of discretion by the ALJ with respect to the cross-examination of Surveyor Schwarz.  The transcript indicates that Petitioner’s lawyer asked Surveyor Schwarz several questions about her education, training, and experience, including her brief employment as a “charge nurse” in a long-term care facility and her experience as a nursing home surveyor.  Tr. at 13-23.  Contrary to Petitioner’s claim, the ALJ did not sustain any “relevance objection” by Surveyor Schwarz to a question about why she had left her job as a nurse in a long-term care facility.  Tr. 23-26.  In fact, the transcript reflects that she was never asked that question. 
Furthermore, at no point during cross-examination did the ALJ direct Petitioner not to pursue a specific line of inquiry.  RR at 8-9.  In response to a question about whether she had cared for long-term care residents with psychiatric diagnoses, Surveyor Schwarz commented that she was “curious about the questions” that were being asked about her “prior employment,” stating her understanding that cross-examination “was going to stick to the declaration and what took place at the Copperas Cove.”  Tr. at 23.  The ALJ interjected that he was “going to raise some of this myself,” advising Petitioner’s lawyer that exploring Schwarz’s background would not be helpful or consequential if the facts about which she testified were undisputed.  Tr. at 23, 25 (“The surveyor found certain facts.  If those facts are disputed, fine, let’s have at it.  If those facts are not in dispute, then it doesn’t matter at this juncture what the surveyor’s background, her training, her qualifications were.”).  The ALJ discouraged further questioning about Surveyor Schwarz’s background, stating that he generally “allow[s] a little bit of that but the bottom line is . . . that we are way [past] that at this point,” and urging Petitioner’s lawyer to focus on whether the facts found by the survey – as related by Surveyor Schwarz – were “valid or not.”  Tr. at 25-26.  The ALJ did not, however, state that he was prohibiting all further questions about the witness’s background, regardless of their

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purpose or relationship to any disputed facts.  And Petitioner’s lawyer did not at that point signal that she understood the ALJ to have made such a ruling.

In raising the cross-examination issue, Petitioner does not cite, quote, or discuss the comments made by the ALJ at the hearing, much less explain how they amount to an abuse of discretion.  As the hearing transcript reveals, the ALJ recommended that Petitioner’s lawyer pursue lines of inquiry that might test the witness’s testimony about disputed material facts.  Tr. at 24-26.  We see nothing inappropriate about that instruction.  *See* *Beatrice State Developmental Ctr.*, DAB No. 2311, at 13 (2010) (rejecting claim that the ALJ had restricted or narrowed the scope of the facility’s cross-examination of CMS’s surveyor, noting that the facility did “not point to any specific question that it was not allowed to ask,” and that the ALJ had “simply attempted to focus [the facility] on eliciting testimony that was ‘relevant and material’ to the issues before her as required under [42 C.F.R.] section 498.60(b)(1)”).

Petitioner asserts that Surveyor Schwarz was “essentially” an expert witness “in that she was specifically designated to give **opinions** about the survey and her conclusions from the survey,” and information about her work history and qualifications was important to assess the credibility or value of her opinions.  RR at 8 (emphasis in original).  However, CMS did not designate Surveyor Schwarz as an expert witness, *see*CMS Pre-Hearing Exchange (dated April 6, 2017), and the ALJ did not accept her as an expert witness.  To the extent any parts of Surveyor Schwarz’s testimony could be characterized as expressing an opinion, Petitioner fails to cite any instance in which it was unable to fully explore the basis for that opinion.  And, the ALJ made it clear at the outset of the hearing that he does “not permit witnesses to testify as to the ultimate issues of law” (*i.e.*, whether a regulation was violated) and that he was “going to disregard the legal conclusions” of both party’s witnesses.  Tr. at 5-6.

Still further, Petitioner has failed to show that the ALJ’s comments regarding cross-examination were prejudicial – that they likely affected the case’s outcome.  Petitioner does not indicate in its request for review – and never told the ALJ – what information it expected to elicit from additional questioning about Surveyor Schwarz’s background, or how that information would have served to impeach specific parts of her direct testimony.  Nor does Petitioner suggest that further questioning about Schwarz’s background would likely have exposed bias or a specific motivation to be untruthful.  Petitioner’s blanket assertion that it was deprived of “potentially significant evidence which would have gone straight to the heart of Ms. Schwarz’s credibility” is simply too vague and speculative to establish prejudice.  *Carrington Place*at 23 (finding no prejudice where the facility “failed to explain with any specificity how the ALJ’s conduct of the hearing impaired its ability to litigate specific issues material to the outcome of the proceeding”).

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For all these reasons, we reject Petitioner’s contention that the ALJ committed a prejudicial abuse of discretion in connection with the cross-examination of Surveyor Schwarz.

**6.       *The ALJ properly rejected Petitioner’s equitable estoppel argument.***

Petitioner contends that the ALJ improperly rejected its equitable estoppel argument.  RR at 5-7 (citing *Heckler v. Cmty. Health Servs. of Crawford Cty., Inc.* 467 U.S. 51 (1984)).   Petitioner invoked the estoppel doctrine in its post-hearing brief, arguing that state surveyors had observed Resident 5 and his room configuration “on at least 25-30 occasions (during each annual inspection)” and “there was never a problem with this configuration until the October 2016 survey.”  Pet.’s Post-Hearing Br. at 5.  “For this reason,” said Petitioner, “CMS should be estopped from imposing enforcement action based upon a room configuration and manner of caring for Resident 5 which had been *approved* by the state survey agency for many years.”  *Id*. (italics added).

The ALJ held that the “doctrine of estoppel plainly does not apply in this case” because Petitioner had not shown that it had been “affirmatively misled by anyone.”  ALJ Decision at 8.  The ALJ noted there was no evidence that the state survey agency had “ever affirmatively condoned” the deficient practices identified during the October 2016 survey.  *Id*.  He added that a SNF’s noncompliance with federal requirements may not be excused on the ground that state surveyors “may have overlooked [the] noncompliance in the past.”  *Id*.

We affirm the ALJ’s rejection of Petitioner’s estoppel claim.  The Board has held that  neither it nor an ALJ is authorized to grant a non-federal party relief from a CMS enforcement action based on equitable defenses or doctrines (such as equitable estoppel), and that an administrative appeal of such an action must be decided based on applicable statutes and regulations.  *See* *Kensington Diagnostics LLC*, DAB No. 2992, at 16 (2020); *Oaks of Mid City Nursing & Rehab. Ctr.*, DAB No. 2375, at 31 (2011) (“In general, neither the Board nor an administrative law judge is authorized to provide equitable relief.”); *see also* *Linda Silva, P.A.*, DAB No. 2966, at 8 n.6 (2019) (“The merits of any estoppel claim . . . are ultimately immaterial because . . . the Board is not empowered to grant relief based on equitable doctrines, theories, or reasons.”).

Even if equitable estoppel were available (which it is not), the record evidence does not support the elements of such a claim.  First, “estoppel against the government cannot be asserted on the basis of *oral* advice.”  *Linda Silva, P.A.*at 8 n.6; *see also FDIC v. Royal Park No. 14*, *Ltd.*, 2 F.3d 637, 641 (5th Cir. 1993) (“[E]rroneous oral representations from a government agent, without more, are insufficient to prove the element of reasonable reliance.”) (citing *Heckler*, 467 U.S. at 65-66)); *Wash. State Dept. of Soc. & Health Servs.*, DAB No. 1561, at 10 (1996) (“[E]rroneous oral advice is inadequate, as a matter of law, to estop the government from enforcing federal law.”).  Petitioner

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presented no evidence that any survey team had previously “approved” Resident 5’s room configuration or Petitioner’s “manner of caring” for Resident 5 in any written documentation.  Petitioner also made no showing that any prior surveyor considered and approved, in writing, the specific practices that led to the noncompliance findings in this case.24

Second, a claim of estoppel against the federal government requires a showing of “affirmative misconduct” by a government actor; but, affirmative misconduct
is “more than the mere negligent provision of erroneous advice; it is akin to deliberate or reckless misrepresentation.”  *Kensington Diagnostics* at 16; *see also Linda Silva, P.A.*at 8 n.6 (explaining that affirmative misconduct is “something more than failing to provide accurate information or negligently dispensing erroneous advice”); *Ingalls Shipbuilding, Inc. v. Dir., Off. of Workers’ Comp., U.S. Dep’t of Labor*, 976 F.2d 934, 938 (5th Cir. 1992) (noting that affirmative misconduct is “more than mere negligence, delay, inaction, or failure to follow an internal agency guideline” (internal quotation marks omitted)).  Petitioner did not allege, much less present evidence, that the state surveyors engaged in any “affirmative misconduct” by allegedly approving Resident 5’s room configuration or Petitioner’s “manner of caring” for him during prior surveys.

Third, Petitioner failed to present evidence that it satisfied other necessary conditions for estoppel, including reasonable reliance upon, and harm flowing from, a government actor’s misrepresentation.  *See Southlake Emergency Care Ctr*., DAB No. 2402, at 8 (2011) (noting that the “traditional requirements” for estoppel include a factual misrepresentation by the government, reasonable reliance on the misrepresentation by the party seeking estoppel, and harm or detriment to that party as a result of the reliance); *see also* *Heckler*, 467 U.S. at 61 (“[H]owever heavy the burden might be when an estoppel is asserted against the Government, the private party surely cannot prevail without at least demonstrating that the traditional elements of an estoppel are present.”).

In its request for review, Petitioner makes the vague assertion that “express representations” were made by the state survey agency “regarding Resident 5’s room configuration and other matters relevant to this case for over 25 years, which were directly relied upon by Petitioner,” and that these representations should estop CMS from taking “any enforcement action based on survey findings which contradict the state survey’s prior express representations.”  RR at 6.  Petitioner cites no evidence of any pre-October 2016 representations by surveyors concerning the resident-care practices at issue in this case.  Still further, Petitioner does not explain how, when, or to whom these

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alleged “express representations” were communicated or why they would be considered false or misleading.

Despite these shortcomings, Petitioner asserts that three witnesses (Heather Beaver, Joshua Henderson, and Yvonne Fortson) “established” detrimental reliance on the survey agency’s alleged “representations.”  RR at 7.  But none of these witnesses described any factual misrepresentation by surveyors before the October 2016 survey.  At most, the witnesses suggested that certain unspecified resident-care practices or “interventions” found deficient during the October 2016 survey had not been cited during prior surveys.  *See, e.g.*, P. Ex. 6 (Beaver Decl.), at 7 (“The interventions that were in place, had been in place for years – and were not seen as problematic by any health or life safety team . . .”); P. Ex. 7 (Henderson Decl.), at 5 (“It is my understanding in the 25-plus years that Resident #5 and his room have been a part of Copperas Cove, . . . there was never a problem with this configuration until the October 2016 survey.”); P. Ex. 8 (Fortson Decl.), at 5 (same as Henderson’s declaration).

None of Petitioner’s witnesses explained in what way Petitioner suffered a “detrimental change in position” when prior survey teams allegedly failed to cite Petitioner for deficient practices it had no right to continue.  *See Heckler*, 467 U.S. at 61-62 (rejecting estoppel claim against the government in recoupment action where health care provider’s alleged “detriment” was its “inability to retain money it should never have received in the first place”).  Here, Petitioner lost no legal right and suffered no adverse change in status – and hence suffered no detriment – based on anything the survey agency allegedly did (or failed to do) prior to the October 2016 survey.  Indeed, we have long rejected the premise that CMS is barred from enforcing compliance with a Medicare participation requirement merely because it could have taken, but failed to take, such action earlier.  *See Batavia Nursing* at 33 (noting that facility “cited to no authority which holds CMS is precluded from issuing a citation for a deficiency simply because CMS had not cited it previously”).

Still further, the key allegation underlying Petitioner’s estoppel claim – that the survey agency had “approved” Resident 5’s “room configuration” prior to the October 2016 survey – is beside the point because the room configuration itself was not a basis for CMS’s enforcement action.  The enforcement action was based instead on findings that Petitioner applied a medically unnecessary chemical restraint, used involuntary seclusion for the convenience of staff, failed to implement its own policy regarding involuntary seclusion, and had an emergency evacuation plan that did not provide for the protection of all residents.  Petitioner made no showing that any prior surveyor specifically considered and “approved” the practices that led to these noncompliance findings.25

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Petitioner further complains that it was unable to establish the “representations/ misrepresentations” supporting its equitable estoppel claim because the ALJ “wrongly” denied its request to subpoena testimony from certain managerial employees of the
state survey agency.  RR at 7.  Section 498.58 of the governing administrative appeal regulations provides that an ALJ may issue subpoenas “if they are reasonably necessary for the full presentation of a case.”  42 C.F.R. § 498.58(a).  Applying section 498.58, the Board has held that an ALJ may properly deny a subpoena request if it seeks testimony or documents that are “irrelevant or immaterial to [her] decision-making.”  *Horace Bledsoe, M.D., et al.,*DAB No. 2753, at 12-13 (2016).

We find no abuse of discretion or prejudicial error by the ALJ because Petitioner’s subpoena request did not meet section 498.58’s requirements.  First, Petitioner’s argument that testimony from “upper level survey personnel” was necessary to “further establish” misrepresentations by the state survey agency does not make sense.  RR at 7.  Evidence of any misrepresentation, if it exists, would necessarily be within the knowledge of Petitioner’s employees or representatives who witnessed or kept records of the alleged misrepresentations that they relied on.  Petitioner’s witnesses, however, presented no such evidence.  Second, as discussed above, neither the ALJ nor the Board may grant equitable relief in an enforcement action such as this.  Thus, to the extent Petitioner sought the subpoenas to support its equitable estoppel argument, the request was not “reasonably necessary for the full presentation” of its case.  *Cf. Michael Turano, M.D.*, DAB No. 2922, at 15 (2019) (holding that the ALJ did not err or abuse her discretion in denying the requested subpoenas “where discovery was sought to support an equity-based claim which the ALJ correctly stated could not be the basis for” reversing CMS’s enrollment determination); *Horace Bledsoe* at 13 (holding that any error in denying subpoena request relating to issues of “equity” was harmless because the documents sought “would not alter [the Board’s] dispositive legal conclusion”).

For all these reasons, we affirm the ALJ’s decision declining to grant Petitioner relief based on equitable estoppel.

**7.       *CMS’s immediate-jeopardy findings are not clearly erroneous.***

“Immediate jeopardy” is defined in CMS’s regulations as a “situation in which the [SNF’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.  A finding by CMS “as to the level of [a SNF’s] noncompliance,” such as a finding of immediate jeopardy, must be upheld unless it is “clearly erroneous.”  *Id*.§ 498.60(c)(2).  Under that review standard, an immediate-jeopardy finding is presumed to be correct, and the SNF has a “heavy burden” to overturn it.  *Crawford Healthcare & Rehab.*, DAB No. 2738, at 14-15 (2016); *see also Libertywood Nursing Ctr.*, DAB No. 2433, at 18 (2011) (noting that under the clearly erroneous standard, “the harm or threatened harm caused by the noncompliance is presumed to be serious, and the facility

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has the burden to rebut the presumption with evidence and argument showing that the harm or threatened harm did not meet any reasonable definition of ‘serious’”) (omitting some internal quotation marks)), *aff’d*, 512 F. App’x 285 (4th Cir. 2013).

In this case, CMS found that Petitioner’s violations of sections 483.13(b), 483.13(c), and 483.70(a)(1)(i) (LSC Standard 19.7.1.1) were each at the immediate-jeopardy level of severity.  *See*CMS Ex. 1, at 1; CMS Ex. 2, at 9-10, 16; CMS Ex. 3, at 18-19, 38-39.  CMS found that the violations of sections 483.13(b) and 483.13(c) were at the immediate-jeopardy level because they had resulted in the unreasonable involuntary seclusion of Resident 5, a circumstance that caused, or could have caused, “emotional stress,” “loss of dignity,” and “psychosocial harm” to the resident.  CMS Ex. 35 (Austin Decl.), at 3, 4; CMS Ex. 36 (Schwarz Decl.), at 10, 11; CMS Ex. 3, at 18-19.  CMS found that the Life Safety Code violation was at the immediate-jeopardy level because it could have delayed the timely evacuation of Resident 5 and two bed-bound residents and thus caused “serious harm or death if the residents were [thereby] exposed to smoke and fire.”  CMS Ex. 2, at 10.  The ALJ concluded that these findings were not clearly erroneous, stating:

There was a likelihood of serious injury, harm, or death resulting from Petitioner’s noncompliance.  As I have discussed, Petitioner’s treatment of Resident # 5 rendered him a prisoner for much of his stay at the facility, confining him to a locked room without any stimuli.  That constitutes deprivation of the most basic human rights, tantamount to imprisoning Resident # 5 in solitary confinement.  Moreover, Petitioner lacked a specific plan for evacuating the resident and other helpless residents in the event of an emergency.  In that circumstance, a fire for example, the consequences for these residents very likely would have been lethal.

ALJ Decision at 6.

Petitioner has identified no valid basis to overturn the ALJ’s conclusion that CMS’s immediate-jeopardy findings were not clearly erroneous.  Petitioner does not contend the ALJ’s rationale for sustaining those findings is based on factual errors or reflects a misapplication or misunderstanding of the regulatory definition of immediate jeopardy.  In opposing CMS’s immediate-jeopardy findings, Petitioner asserts that the survey agency improperly characterized the “scope” of its noncompliance with sections 483.13(b) and 483.13(c) as a “pattern” because that noncompliance “involved only one resident and one incident.”  RR at 13-14 (referring to Resident 5).  Petitioner misunderstands the immediate-jeopardy analysis, which concerns the *severity*of each deficiency (the extent to which it caused or had the potential to cause serious harm to one

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or more residents), not its scope.26
  In any event, Petitioner failed to show that its noncompliance with sections 483.13(b) and 483.13(c) was not a “pattern.”  Indeed, the ALJ specifically rejected Petitioner’s contention that its noncompliance involved only one incident.  ALJ Decision at 10 (“[T]here clearly was a pattern of immediate jeopardy level noncompliance here.  The mistreatment of Resident # 5 continued – by Petitioner’s own admission – for years.”).
Petitioner further contends that the immediate-jeopardy findings should be overturned because they allegedly did not meet criteria specified in Appendix Q to CMS’s State Operations Manual.  RR at 13-14, 15.  Appendix Q sets forth guidance to assist survey agencies in making findings of immediate jeopardy under the applicable legal standards.  *See Pinecrest Nursing & Rehab. Ctr.*, DAB No. 2446, at 18 (2012). The State Operations Manual and its appendices are updated and revised periodically, but Petitioner does not indicate what version of Appendix Q it is relying upon.  Petitioner asserts that, according to the version of Appendix Q it consulted, “three components must be identified” in order to find that a deficiency is at the immediate-jeopardy level of severity:  “(1) Harm (actual or potential); (2) Immediacy; and (3) Culpability.”  RR at 14.  Petitioner submits that CMS’s immediate-jeopardy findings concerning the violations of section 483.13(b) and 483.13(c) “cannot stand” because Appendix Q’s “immediacy” and “culpability” criteria are not satisfied.  *Id*.  Petitioner further contends that the immediate-jeopardy finding relating to the Life Safety Code deficiency is erroneous because “the requisite elements of harm, immediacy, and culpability are simply not present.”  RR at 15.

We reject these contentions, for several reasons.  First, Petitioner did not submit for the record a copy of the version of SOM Appendix Q on which it relies.  The current version of Appendix Q does not contain (much less define) the term “immediacy,” nor does it specify “culpability” as an element of an immediate-jeopardy finding.  *See* State Operations Manual (CMS Pub. 100-07), “Appendix Q – Core Guidelines for Determining Immediate Jeopardy,” available at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107ap_q_immedjeopardy.pdf.

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Second, contrary to Petitioner’s implication, Appendix Q’s guidance does not establish enforceable or binding legal standards.  “Appendix Q’s purpose is to guide surveyors in applying a regulatory standard, not to define that standard.”  *Pinecrest*at 19.  The applicable standard is found in 42 C.F.R. § 488.301, which defines immediate jeopardy as a situation in which a deficiency caused or was likely to cause serious harm, injury, or death to a resident.  *Id*.; *see also Agape Rehab. of Rock Hill*, DAB No. 2411, at 19 (2011) (noting that Appendix Q’s specification of “immediacy” as a required element to find immediate jeopardy is “not . . . legally binding” and that the applicable regulations do not “set[ ] any parameters as to the timing of potential harm”); *Kindred Transitional Care & Rehab. – Greenfield*, DAB No. 2792, at 20 (2017) (rejecting contention that “culpability is a necessary element of immediate jeopardy based on Appendix Q’s discussion of culpability”).

Third, in arguing that CMS failed to prove the elements of immediate jeopardy specified in Appendix Q, Petitioner disregards its burden under the clearly erroneous standard.  Under that standard, it was not CMS’s burden to show that the violations of section 483.13(b), 483.13(c), and Life Safety Code met the regulatory criteria for an immediate-jeopardy finding.  Rather, it was Petitioner’s burden to demonstrate that CMS’s immediate-jeopardy findings were clearly erroneous.  *See* 42 C.F.R. § 498.60(c)(2); *Miss. Care Ctr. of Greenville*, DAB No. 2450, at 15 (2012), *aff’d*, 517 F. App’x 209 (5th Cir. 2013).

Petitioner has not met that burden here.  For example, it did not show that the violations of section 483.13(b) and 483.13(c) found by the ALJ did not cause, or were not likely to cause, serious harm to Resident 5.  *See*RR at 14.  Petitioner suggests that sedating and confining Resident 5 to his locked room was not harmful but was for his own good.  *Id*.(stating that “the only ‘immediate threat’ to Resident #5 or to any other resident was created by the surveyors’ insisting that Resident #5’s safe haven be all but taken away as the only acceptable way for the facility to be taken off of IJ status”).  We reject this premise for the reasons already discussed.  *See supra* at 27 (noting that CMS had proffered uncontested evidence that Petitioner’s failure to follow its policy regarding involuntary seclusion caused significant harm to Resident 5, including social isolation and loss of dignity).  Petitioner likewise fails to provide any analysis supporting its challenge to the immediate-jeopardy finding relating to the Life Safety Code deficiency.  Because CMS’s characterization of the severity of that deficiency is “a matter of professional judgment and expertise” and owed deference for that reason, *see Daughters of Miriam Ctr.*, DAB No. 2067, at 15 (2007), a facility seeking to overturn an immediate-jeopardy finding must do more than perfunctorily state in a legal brief that the finding is erroneous.

For all these reasons, we affirm the ALJ’s conclusion that CMS’s immediate-jeopardy findings were not clearly erroneous.

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**8.        *Petitioner has raised no issue concerning the duration of the noncompliance and immediate-jeopardy periods.***

CMS found that Petitioner was noncompliant from October 16 through November 3, 2016, and that its noncompliance was at the immediate-jeopardy level of severity from October 13 through 15, 2016.  *See*CMS Ex. 1, at 9.  The ALJ adopted these findings, noting that Petitioner had proffered no evidence to contest them.  ALJ Decision at 11.  We summarily affirm these findings because Petitioner raises no issue in this appeal concerning the duration of its noncompliance.

**9.*Petitioner identifies no basis to overturn the ALJ’s finding that the per-day CMP amounts imposed by CMS are**reasonable.***

When a SNF is found noncompliant with one or more Medicare participation requirements, the ALJ may review whether a CMP imposed by CMS is reasonable.  *See*42 C.F.R. § 488.438(e)(1)-(2); *Crawford Healthcare* at 18-19.  In deciding whether a CMP is reasonable, the ALJ may consider only the factors specified in 42 C.F.R. § 488.438(f).  42 C.F.R. § 488.438(e)(3); *Crawford Healthcare*at 19.  Those factors are:  (1) the SNF’s history of noncompliance; (2) the SNF’s financial condition – that is, its ability to pay the CMP; (3) the “seriousness” of the noncompliance; (4) the SNF’s degree of culpability, which includes neglect, indifference, or disregard for resident care, comfort or safety; and (5) the relationship of one deficiency to other deficiencies resulting in noncompliance.  42 C.F.R. §§ 488.438(f), 488.404(a)-(c); *Crawford Healthcare*at 19.  “The Board has held that the CMP amount selected by CMS is presumptively reasonable based on those factors, and that the burden is on the SNF to demonstrate, through argument and the submission of evidence addressing the regulatory factors, that a reduction [in the penalty amount] is necessary to make the CMP amount reasonable.”  *Good Shepherd Home for the Aged, Inc.*, DAB No. 2858, at 23 (2018); *see also* *Crawford Healthcare*at 19 (stating that the Board “presume[s] that CMS considered the regulatory factors in choosing a CMP amount and that those factors support the penalty imposed”).

In this case, CMS imposed two CMPs:  an $11,641 per day CMP for three days of noncompliance at the immediate-jeopardy level (October 13 through October 15, 2016); and a $2,053 per day CMP for 19 days of noncompliance below the immediate-jeopardy level (October 16 through November 3, 2016).  CMS Ex. 1, at 9.  The accrued penalties totaled $73,930.  *Id*.

Noting that the per-day CMP amounts in this case were only a fraction of the maximum amounts allowed under the regulations (one-half of the maximum allowable for immediate-jeopardy-level noncompliance, and approximately one-third of the maximum  allowable for non-immediate-jeopardy-level noncompliance), the ALJ found that the penalties were “modest” given the “egregiousness” of Petitioner’s noncompliance –

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which he said “severely impinged on the rights of Resident # 5” and endangered “helpless residents” in the event of fire – and Petitioner’s “high degree of culpability.”  ALJ Decision at 11.  Based on these findings, the ALJ concluded that the CMP amounts were reasonable.  *Id*.

Petitioner does not acknowledge or attempt to challenge any element of the ALJ’s reasonableness evaluation.  Petitioner merely repeats, verbatim, the perfunctory argument that it made before the ALJ.  RR at 15 (arguing that the total CMP is “unjustified,” that its actions did not cause any resident harm, and that the regulatory factors were “not properly applied by CMS”); *see also* Pet.’s Post-Hearing Br. at 22.  Petitioner’s argument is insufficient because it does not purport to show that either of the per-day penalty amounts was unreasonable – Petitioner merely asserts that the *total**accrued*penalty of $73,930 “is not justified.”  RR at 15.  However, the issue here is the reasonableness of the per-day amounts, not the total accrued amount (which mainly reflects the duration of Petitioner’s noncompliance).  *See* *Kenton Healthcare, LLC*, DAB No. 2186, at 28 (2006).  “Stating that the total CMP amount is ‘not reasonable’ does not raise a clear dispute about the reasonableness of the per-day CMP amounts.”  *Crawford Healthcare* at 20 (internal quotation marks omitted).  In reviewing the reasonableness of a per-day CMP, “we look at the per day amount, not at the total amount of the CMP.”  *Id*.(quoting *Century Care of Crystal Coast*, DAB No. 2076, at 26 (2007), *aff’d*, 281 F. App’x 180 (4th Cir. 2008)).

Petitioner’s argument is also insufficient because, with one exception, it made no attempt to show that the regulatory factors warrant a reduction in the CMP.  Petitioner merely stated, without explanation or citation to the record, that the factors “were not properly applied” by CMS.  Such conclusory arguments are insufficient.  Indeed, the burden is on Petitioner to demonstrate, through argument and the submission of evidence addressing the regulatory factors, that a reduction is necessary to make the CMP amount reasonable.  *See* *Good Shepherd Home* at 23.

Petitioner alludes to only one regulatory factor – the seriousness of the noncompliance – and argues that its deficiencies “did not cause any resident harm.”  RR at 15.  The ALJ rejected the premise of this contention, concluding that Petitioner’s deficiencies caused Resident 5 actual harm.  ALJ Decision at 5 (“The evidence graphically proves that Petitioner failed to furnish a dignified existence to Resident #5.”); 7 (“I find the use of chemical restraints (Risperidone) to sedate Resident #5 to have caused actual harm.”); 9 (“Sedating an individual on a long term basis is an attack on the quality of that person’s life.  That is the harm that resulted from Petitioner’s reliance on Risperidone to restrain Resident #5.”).  In terms of the seriousness of Petitioner’s noncompliance, the ALJ further concluded that several of Petitioner’s deficiencies reached the immediate-jeopardy level of severity.  *Id*. at 6 (“The evidence amply supports CMS’s determinations of immediate jeopardy.”).  For the reasons previously discussed, we find no error in the ALJ’s findings regarding actual harm and immediate jeopardy.  Petitioner suggests no

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other basis on which to reduce the per-day CMP amounts chosen by CMS and, therefore, we affirm the ALJ’s conclusion that they are reasonable.

Conclusion

For the reasons stated above, we affirm the ALJ’s decision and sustain the CMPs imposed by CMS against Petitioner.


          /s/
        Constance B. Tobias

                      Board Member
          /s/
        Susan S. Yim

                      Board Member
          /s/
        Michael Cunningham

                      Presiding Board Member
      1. On October 4, 2016, CMS issued a final rule that amended the Medicare participation requirements for long-term care facilities published in 42 C.F.R. Part 483, subpart B.  Final Rule, Medicare and Medicaid Programs; Reform of Requirements for Long-Term Care Facilities, 81 Fed. Reg. 68,688 (Oct. 4, 2016).  That final rule became effective on November 28, 2016.  Id.  Our analysis is based on the version of the participation requirements in effect during October 2016, when the compliance survey supporting CMS’s enforcement action was performed.  Carmel Convalescent Hosp., DAB No. 1584, at 2 n.2 (1996) (applying the regulations in effect on the date of the survey and resurvey). back to note 1
                      2. Resident 5 was seven years old when he first entered the facility.  CMS Ex. 5, at 1. back to note 2
                      3. This determination was based on revisit surveys of Petitioner performed in mid-November 2016.  CMS Ex. 33, at 2. back to note 3
                      4. Petitioner requested oral argument due to the “extremely unique fact pattern involving an atypical nursing facility resident.”  Pet.’s Request for Review at 17.  We find that the parties’ positions are adequately explained in their appeal briefs, and that we can make a sound decision based on those submissions and the record developed before the ALJ.  Accordingly, we deny the request for oral argument. back to note 4
                      5. Effective November 28, 2016, the language limiting restraint use was moved to 42 C.F.R. §§ 483.10(e)(1) and 483.12(a)(2).  81 Fed. Reg. at 68,750, 68,827. back to note 5
                      6. The current version of the Social Security Act can be found at https://www.ssa.gov/OP_Home/ssact/ssact-toc.htm.  Each section of the Act on that website contains a reference to the corresponding United States Code chapter and section.  Cross-reference tables for the Act and the United States Code can be found at http://uscode.house.gov/table3/1935_531.htm and https://www.ssa.gov/OP_Home/comp2/G-APP-H.html. back to note 6
                      7. Risperidone “works by changing the activity of certain natural substances in the brain.”  CMS Ex. 3, at 3-4 (internal quotation marks omitted) (quoting MedlinePlus factsheet regarding Risperidone, available at https://medlineplus.gov/druginfo/meds/a694015.html). back to note 7
                      8. Indeed, the physician’s stated reason for the increased dose conflicts with Petitioner’s Antipsychotic Drug Use policy.  That policy provides that antipsychotic medication should not be used if restlessness is the only “indication” for the drug’s use.  CMS Ex. 30, at 5.  In addition, Petitioner’s psychoactive medication therapy consent form indicates that restlessness is a possible side effect or risk of using antipsychotic medication.  CMS Ex. 5, at 87. back to note 8
                      9. The physician’s June 17, 2016 order increased Resident 5’s total daily dose of Risperidone by 3.0 mg per day – from 1.0 mg (0.5 mg twice daily) to 4.0 mg (2.0 mg twice daily).  The drug’s FDA labeling indicates that the maximum titration for the indicated uses (such as bipolar disorder) was 2.0 mg per day.  CMS Ex. 7, at 1, 4-6. back to note 9
                      10. In its post-hearing brief to the ALJ, CMS acknowledged that on the day the physician increased Resident 5’s Risperidone dose (June 17, 2016), Resident 5 was reportedly “aggressive and agitated making loud high pitched noises and pulling other residents hair.”  CMS Post-Hearing Br. at 12 (quoting CMS Ex. 5, at 53).  However, CMS further noted there was “no documentation” that the physician’s order was related to that incident, and the nursing staff responded to Resident 5’s behavior that day by giving him Ativan with “good results.”  Id. (quoting CMS Ex. 5, at 53).  We see nothing in the record contradicting these assertions by CMS. back to note 10
                      11. The Use of Restraints policy includes (at the bottom) an express “reference” to 42 C.F.R. § 483.13(a).  CMS Ex. 30, at 3. back to note 11
                      12. These specific conditions were:  schizophrenia; schizo-affective disorder; delusional disorder; psychotic mood disorders; acute psychotic episodes; brief reactive psychosis; schizophreniform disorder; atypical psychosis; Tourette’s disorder; Huntington’s disease; and “organic mental syndromes (now called delirium, dementia, and amnestic and other cognitive disorders by DSM-IV) with associated psychotic and/or agitated behaviors” that meet several other listed criteria.  CMS Ex. 30, at 4-5. back to note 12
                      13. Exhibit B to the request for review, titled “Copperas Cove Aggressive Behavior Record,” is a chronological summary of progress notes and other clinical records (found in Petitioner’s Exhibit 4 and CMS’s Exhibit 5) that document Resident 5’s behavior between May 2016 and May 2017.  Most of the documented behavior summarized in Exhibit B occurred after the October 2016 survey. back to note 13
                      14. In an attempt to bolster Nurse Merritt’s testimony on this point, Petitioner’s request for review cites a medical journal article (Miller, “Atypical Antipsychotics:  Sleep, Sedation, and Efficacy,” Prim. Care Companion J. Clin. Psychiatry (2014)).  See RR at 10.  However, Petitioner did not include the article in its pre-hearing exchange, and Nurse Merritt did not cite the article in her testimony.  In addition, Petitioner did not include a copy of the article with its request for review or ask that it be made part of the record.  We therefore do not consider it. back to note 14
                      15. Nursing records indicate that staff continued to administer Ativan to Resident 5 after June 17, 2016.  See, e.g., CMS Ex. 5, at 51 (Sept. 28, 2016 at 13:20); P. Ex. 4, at 41 (Aug. 19, 2016 at 10:18). back to note 15
                      16. No practitioner ordered that the dosage be increased to the level before the survey (2.0 mg twice daily).  The November 2016 dose-increase was ordered by a psychiatric nurse practitioner (PNP), not Resident 5’s physician.  On November 10, 2016, the PNP increased Resident 5’s Risperidone dose – but the increase was only from 0.5 mg to 1.0 mg twice daily.  P. Ex. 4, at 32.  Approximately three weeks later, the PNP declined a recommendation to increase the dose further.  Id. at 28-29.  Post-survey clinical records disclose no further increase or recommended increase in the dose.  See id. at 3-28. back to note 16
                      17. Still further, Petitioner’s argument overlooks the fact that section 483.13(c) is not limited to policies that prohibit “abuse,” but also requires a facility to develop and implement policies prohibiting “mistreatment,” a term certainly broad enough to include involuntary seclusion.  See 42 C.F.R. § 483.5 (Oct. 1, 2020) (defining “mistreatment” as “inappropriate treatment or exploitation of a resident”).  Here, the ALJ explicitly found that Petitioner had “affirmatively mistreated” Resident 5 by sedating and secluding him for extended periods.  ALJ Decision at 7.  Petitioner does not argue that its policy concerning seclusion was not designed or intended to prevent resident mistreatment.  We further hold that Petitioner’s written policy that seclusion not be used (except as a short-term measure in limited circumstances) also constitutes a policy prohibiting “mistreatment” within the meaning of section 483.13(c). back to note 17
                      18. For the sake of discussion, we assume that Petitioner meant the term “restraints” to include involuntary seclusion. back to note 18
                      19. PASRR is an acronym for Preadmission Screening and Resident Review, a tool to identify persons with serious mental illness and intellectual disability.  See St. Catherine’s Care Ctr. of Findlay, Inc., DAB No. 1964, at 7 n.7 (2005); 42 C.F.R. Part 483, subpart C. back to note 19
                      20. Because the failure to identify special-needs residents in Appendix B of the EPP is a sufficient reason to affirm the ALJ’s noncompliance finding, we need not address his other findings regarding the Life Safety Code, including that the EPP did not address the “specific needs” of the facility’s bed-bound residents.  We note, however, that Petitioner does not challenge that specific finding in this appeal. back to note 20
                      21. Petitioner’s plan of removal made clear it had not prepared or updated Appendix B until after the immediate-jeopardy noncompliance was identified during the October 2016 survey.  CMS Ex. 2, at 12 (“An audit of all residents’ mode of transportation was completed to identify the correct order and specialized needs in the event of an emergency evacuation and a list was formulated. . . .  The list of identified PASRR positive residents was formulated and placed in each disaster plan manual . . . .”). back to note 21
                      22. Petitioner’s argument that it was entitled to a subpoena to show that the survey agency had approved its EPP in years prior is apparently related to its contention that CMS should be equitably estopped from enforcing compliance with the participation requirements at issue in this case.  See RR at 7.  We reject that contention for the reasons set forth more fully below. back to note 22
                      23. If the state survey agency had, in fact, previously reviewed the EPP and specifically determined that it complied with LSC Standard 19.7.1.1., Petitioner presumably would have access to such evidence through its own employees or documents.  In any event, as explained herein, a prior compliance finding on this issue by a state survey agency would have no bearing on this case. back to note 23
                      24. Petitioner asserts that representations by the state survey agency may support an estoppel claim against CMS because the state survey agency was acting as CMS’s “agent” and within its apparent authority.  RR at 6.  We do not decide that legal issue here, and nothing in this discussion should be construed as accepting Petitioner’s contention that CMS may be estopped based on the misrepresentations or affirmative misconduct of state surveyors. back to note 24
                      25. Petitioner’s contention that the “interventions” found deficient in October 2016 had been in place for 25-plus years is also unsupported by the record.  For example, the four-fold increase of Risperidone that resulted in noncompliance with section 483.13(a) first occurred in June 2016. back to note 25
                      26. An immediate-jeopardy determination can certainly be sustained based on an “isolated” deficiency – e.g., a deficiency affecting a single or limited number of residents.  See, e.g., Hallmark House Nursing Ctr., DAB No. 2226, at 13 (2009) (quoting CMS’s then-current definition of “isolated” and stating that an isolated deficiency may result in immediate jeopardy if it “either caused or was likely to cause serious injury, harm, impairment or death to any resident”); Putnam Ctr., DAB No. 2850, at 33 (2018) (“[H]arm or the likelihood of harm to a single resident can be the basis for an immediate jeopardy determination.”), aff’d, 770 F. App’x 630 (4th Cir. 2019); 42 C.F.R. § 488.301 (defining immediate jeopardy as a situation that “has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident” (italics added)).  Petitioner failed to explain why the findings regarding the scope of its deficiencies matter to the outcome of this case. back to note 26 Back to top
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