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                              Focused Care At Midland, CR6330 (2023)
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Focused Care At Midland, CR6330 (2023)








  
  
    

  
      
Department of Health and Human Services 
    DEPARTMENTAL APPEALS BOARD
          Civil Remedies Division





Focused Care At Midland,
(CCN: 675985),
Petitioner,

v.

Centers for Medicare & Medicaid Services.
Docket No. C-20-789Decision No. CR6330August 11, 2023

        
              
    

      DECISION

Petitioner, Focused Care at Midland, was not in substantial compliance with program participation requirements established by 42 C.F.R. §§ 483.12 and 483.25(d) from February 6 through March 10, 2020, which posed immediate jeopardy to Petitioner’s residents.  There is a basis for the imposition of an enforcement remedy of a per-day civil money penalty (CMP) of $14,100 for 10 days of immediate jeopardy from February 6 through 15, 2020, and a per-day CMP of $150 from February 16 through March 10, 2020.

I.    Background

Petitioner is in Midland, Texas and participates in Medicare as a skilled nursing facility (SNF) and the state Medicaid program as a nursing facility (NF).  Joint Stipulations (Jt. Stip.) at 1, Centers for Medicare & Medicaid Services’ Exhibit (CMS Ex.) 1; Petitioner’s Prehearing Brief (P. Prhg. Br.) at 3.

The Texas Health and Human Services Commission (state agency) completed complaint investigations of Petitioner on February 15, 2020.  CMS Ex. 2, Jt. Stip. at 2.  The state agency notified Petitioner of its findings of noncompliance by letter dated March 3, 2020.  The state agency advised Petitioner that it was recommending that CMS impose

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enforcement remedies.  Petitioner requested a hearing before an administrative law judge (ALJ) on April 29, 2020.  The case was docketed as C-20-493 and assigned to me for hearing and decision on April 30, 2020.

CMS notified Petitioner of its initial determination by letter dated September 14, 2020.  CMS advised Petitioner that it concurred with the state agency findings of noncompliance with participation requirements established by 42 C.F.R. §§ 483.12(a) and 483.25(d) and three other regulations1  and that it was imposing the following enforcement remedies:  a CMP of $14,100 per day from February 6 through 15, 2020; and a CMP of $150 per day from February 16 through March 22, 2020.  CMS Ex. 1 at 1-3.  However, the September 14, 2020 letter notified Petitioner that it returned to substantial compliance with Medicare participation requirements2  effective March 11, 2020.  CMS Ex. 1.  CMS subsequently notified Petitioner that the $150 per day CMP stopped accruing on March 10, 2020, the day prior to Petitioner’s return to substantial compliance.  CMS Ex. 11.

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Petitioner filed a second request for an ALJ hearing September 25, 2020.  The case was docketed as C-20-789 and assigned to me for hearing and decision on September 29, 2020.  I consolidated C-20-493 with C-20-789 and dismissed C-20-493.

CMS filed CMS Exs. 1 through 10 on January 4, 2021, and CMS Ex. 11 on March 1, 2021.  Petitioner filed Petitioner’s Exhibits (P. Exs.) 1 through 7 on January 27, 2021, and a revised P. Ex. 6 on March 5, 2021.

On March 8, 2021, I set the case for hearing on December 1 and 2, 2021.  On October 12, 2021, Petitioner requested that the hearing be postponed, and the hearing was reset for January 18 and 19, 2022.  On December 19, 2021, Petitioner waived an oral hearing and requested a decision on the written record.  On December 20, 2021, Petitioner’s waiver was accepted and the parties were granted the opportunity to file briefs and additional evidence.  On January 31, 2022, CMS filed an opening brief (CMS Br.) and CMS Exs. 12 through 15).  Petitioner filed its opening brief (P. Br.) and P. Exs. 8 and 9 on January 31, 2022.  Petitioner filed a reply brief (P. Reply) on February 28, 2022.  CMS did not file a reply brief.

CMS Exs. 1 through 15 and P. Exs. 1 through 9 are admitted and considered as evidence.

II.    Discussion

**A.  Applicable Law**

**1.  Statutory and Regulatory Medicare Program Enforcement**

The statutory and regulatory requirements for participation of a SNF in Medicare are at section 1819 of the Social Security Act (Act) and 42 C.F.R. pt. 483.  Section 1819(h)(2) of the Act authorizes the Secretary (the Secretary) of Health and Human Services (HHS) to impose enforcement remedies against a SNF for failure to comply substantially with the federal participation requirements established by sections 1819(b), (c), and (d) of the Act.3   The Act requires that the Secretary terminate the Medicare participation of any SNF that does not return to substantial compliance with participation requirements within six months of being found not to be in substantial compliance.  Act § 1819(h)(2)(C).  The Act also requires that the Secretary deny payment of Medicare benefits for any

Page 4

beneficiary admitted to a SNF if the SNF fails to return to substantial compliance with program participation requirements within three months of being found not to be in substantial compliance – commonly referred to as the mandatory or statutory denial of payments for new admissions (DPNA).  Act § 1819(h)(2)(D).  The Act grants the Secretary discretionary authority to terminate a noncompliant SNF’s participation in Medicare, even if there has been less than six months of noncompliance.  The Act also grants the Secretary authority to impose other enforcement remedies, including a discretionary DPNA, civil money penalties (CMP), appointment of temporary management, and a directed plan of correction.  Act § 1819(h)(2)(B).

The Secretary has delegated to CMS and the states the authority to impose remedies against a SNF or NF that is not in substantial compliance with federal participation requirements.  42 C.F.R. §§ 488.400, 488.402(b), 488.406.  “*Substantial compliance*means 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.”  42 C.F.R. § 488.301 (emphasis in original).  A deficiency is a violation of a participation requirement established by sections 1819(b), (c), and (d) of the Act or the Secretary’s regulations at 42 C.F.R. pt. 483, subpt. B.  42 C.F.R. § 488.301.  The term “noncompliance” refers to any deficiency (statutory or regulatory violation) that causes a facility not to be in substantial compliance; that is, a deficiency that poses a risk for more than minimal harm.  42 C.F.R. § 488.301.  Therefore, even if a facility violates a statutory or regulatory requirement, CMS may not impose enforcement remedies if the deficiency does not pose a risk for more than minimal harm.

State survey agencies survey facilities that participate in Medicare on behalf of CMS to determine whether the facilities are complying with federal participation requirements.  42 C.F.R. §§ 488.10‐.28, 488.300-.335.  The regulations specify the enforcement remedies that CMS may impose if a facility is not in substantial compliance with Medicare requirements.  42 C.F.R. § 488.406.

CMS is authorized to impose a CMP against a facility not in substantial compliance with program participation requirements.  The regulations specify that a CMP that is imposed against a facility on a per day basis will fall into one of two ranges of penalties.  42 C.F.R. §§ 488.408, 488.438.  The upper range of a CMP, $6,808 per day to $22,320 per day, is reserved for deficiencies that pose immediate jeopardy to a facility’s residents and, in some circumstances, for repeated deficiencies.4   42 C.F.R. § 488.438(a)(1)(i),

Page 5

(d)(2); 45 C.F.R. § 102.3 (Table) (2020).  “*Immediate jeopardy* means a situation in which the provider’s noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident.”  42 C.F.R. § 488.301 (emphasis in original).  The lower range of CMPs, $112 per day to $6,695 per day, is reserved for deficiencies that do not pose immediate jeopardy, but either cause actual harm to residents, or cause no actual harm but have the potential for causing more than minimal harm.  42 C.F.R. § 488.438(a)(1)(ii); 45 C.F.R. § 102.3 (Table) (2020).

The Act and regulations make a hearing before an ALJ available to a SNF against which CMS has determined to impose an enforcement remedy.  Act §§ 1128A(c)(2), 1866(h); 42 C.F.R. §§ 488.408(g), 498.3(b)(13).  A facility has a right to appeal a “certification of noncompliance leading to an enforcement remedy.”  42 C.F.R. §§ 488.408(g)(1); 488.330(e), 498.3(b)(13).  However, the choice of remedies, or the factors CMS considered when choosing remedies, are not subject to review.  42 C.F.R. § 488.408(g)(2).  A facility may only challenge the scope and severity level of noncompliance determined by CMS if a successful challenge would affect the range of the CMP that may be imposed or impact the facility’s authority to conduct a nurse aide training and competency evaluation program.  42 C.F.R. § 498.3(b)(14), (d)(10)(i).  The CMS determination as to the level of noncompliance, including the finding of immediate jeopardy, “must be upheld unless it is clearly erroneous.”  42 C.F.R. § 498.60(c)(2); *Woodstock Care Ctr.*, DAB No. 1726 at 9, 39 (2000), *aff’d*, *Woodstock Care Ctr. v. Thompson*, 363 F.3d 583 (6th Cir. 2003).  The Board has long held that the net effect of the regulations is that a provider has no right to challenge the scope and severity level assigned to a noncompliance finding, except in the situation where that finding was the basis for an immediate jeopardy determination.  *See, e.g*., *Ridge Terrace*, DAB No. 1834 (2002); *Koester Pavilion*, DAB No. 1750 (2000).  ALJ review of a CMP is subject to 42 C.F.R. § 488.438(e).

Petitioner states that it was notified by the state agency that approval of Petitioner to conduct a nurse aide training and competency evaluation program (NATCEP) would be withdrawn.  P. Br. at 2.  Ineligibility to conduct a NATCEP is not an enforcement remedy that the state agency and CMS have the authority or discretion to impose.  42 C.F.R. § 488.406 (list of remedies CMS and the state agency are authorized to impose in addition to termination).  Pursuant to sections 1819(b)(5) and 1919(b)(5) of the Act, SNFs and NFs may only use nurse aides who have completed a training and competency evaluation program.  Pursuant to sections 1819(f)(2) and 1919(f)(2) of the Act, the Secretary was tasked to develop requirements for approval of NATCEPs and the process for review of those programs.  Sections 1819(e) and 1919(e) of the Act impose upon the states the requirement to specify what NATCEPs they will approve that meet the requirements that the Secretary established and a process for reviewing and re-approving those programs using criteria the Secretary set.  The Secretary promulgated regulations at 42 C.F.R. pt. 483, subpt. D.  Pursuant to 42 C.F.R. § 483.151(b)(2) and (f), a state may

Page 6

not approve and must withdraw any prior approval of a NATCEP offered by a SNF or NF that has been:  (1) subject to an extended or partial extended survey under sections 1819(g)(2)(B)(i) or 1919(g)(2)(B)(i) of the Act; (2) assessed a CMP of not less than $11,160 (45 C.F.R. § 102.3 (Table) (2020)); or (3) subject to termination of its participation agreement, a DPNA, or the appointment of temporary management.  Extended and partial extended surveys are triggered by a finding of “substandard quality of care” during a standard or abbreviated standard survey and involve evaluating additional participation requirements.  “Substandard quality of care” is identified by the situation where surveyors identify one or more deficiencies related to participation requirements established by 42 C.F.R. §§ 483.10, 483.12, 483.24, 483.25, 483.40, 483.45, 483.70 or 483.80, which are found to constitute either immediate jeopardy, a pattern of or widespread actual harm that does not amount to immediate jeopardy, or a widespread potential for more than minimal harm that does not amount to immediate jeopardy and there is no actual harm.  42 C.F.R. § 488.301.  The CMS notice of initial determination dated September 14, 2020 (CMS Ex. 1), and the notice of the revised determination dated January 29, 2021 (CMS Ex. 11), do not mention Petitioner’s eligibility to conduct a NATCEP.  However, the amount of the CMP imposed in this case triggers Petitioner’s ineligibility to be approved to conduct a NATCEP.  Additionally, the noncompliance cited based on the violations of 42 C.F.R. §§ 483.12 and 483.25(d) at the level of immediate jeopardy constitute substandard quality of care which also triggers the ineligibility to conduct a NATCEP in this case.

**2.  Burden of Proof, Burden of Production, and Quantum of Evidence**

The hearing before an ALJ is a de novo proceeding, that is, “a fresh look by a neutral decision-maker at the legal and factual basis for the deficiency findings underlying the remedies.”  *Life Care Ctr. of Bardstown*, DAB No. 2479 at 33 (2012) (citation omitted).

The allocation of the burden of proof and the quantum of evidence required to meet the burden is not addressed by regulations applicable in this case.5  Rather, the Board has

Page 7

long held that the petitioner, i.e., the nongovernmental party affected by CMS action imposing an enforcement remedy, bears the ultimate burden of persuasion to show by a preponderance of the evidence that it was in substantial compliance with participation requirements or any affirmative defense.  *Batavia Nursing & Convalescent Inn*, DAB No. 1911 (2004); *Batavia Nursing & Convalescent Ctr.*, DAB No. 1904 (2004), *aff’d*, *Batavia Nursing & Convalescent Ctr. v. Thompson*, 129 F. App’x 181 (6th Cir. 2005); *Emerald Oaks*, DAB No. 1800 (2001); *Cross Creek Health Care Ctr.*, DAB No. 1665 (1998); *Hillman Rehab. Ctr.*, DAB No. 1611 (1997) (remand to ALJ), DAB No. 1663 (1998) (after remand), *aff’d*, *Hillman Rehab. Ctr. v. United States*, No. 98-3789 (GEB), 1999 WL 34813783 (D.N.J. May 13, 1999).  The Board has indicated that CMS has the initial burden of production to make a prima facie showing of noncompliance, which is determined without consideration or weighing of Petitioner’s evidence.  If CMS makes a prima facie showing, then the facility bears the burden to show, by a preponderance of the evidence on the record as a whole, that it was in substantial compliance or had an affirmative defense.  *Evergreene Nursing Care Ctr.*, DAB No. 2069 at 7-8, 15 (2007).  The Board has not clearly defined the quantum of evidence CMS needs to present to meet its burden of making a prima facie showing.  The Board has stated that CMS must come forward with “evidence related to disputed findings that is sufficient (together with any undisputed findings and relevant legal authority) to establish a prima facie case of noncompliance with a regulatory requirement.”  *Id.*; *Batavia Nursing & Convalescent Ctr.*, DAB No. 1904.  “Prima facie” means generally that the evidence is “[s]ufficient to establish a fact or raise a presumption unless disproved or rebutted.”  *Black’s Law Dictionary*1228 (8th ed. 2004).  One might conclude that if the preponderance of the evidence is required in these proceedings, that standard would also apply to the requirement for CMS to make a prima facie showing, i.e., CMS should be required to present evidence sufficient to establish a fact as more likely true.  However, the Board has never specifically ruled that the CMS prima facie case must be supported by preponderant evidence, or what happens if it is not, including whether Petitioner has the burden of persuasion even if CMS failed to make a prima facie showing on each element

Page 8

of its case.  It is also unclear from prior Board decisions whether CMS can make a prima facie showing with mere allegations or a scintilla of evidence.  The Board has indicated that CMS may make a prima facies showing of noncompliance based solely upon the factual allegations of the statement of deficiencies (SOD) that “are specific, undisputed, and not inherently unreliable.”  *Evergreene*, DAB No. 2069 at 15.  In this case, I conclude CMS has made its prima facie showing by a preponderance of the evidence.

**B.  Issues**

Whether there is a basis for the imposition of an enforcement remedy;

Whether the declaration of immediate jeopardy was clearly erroneous; and

Whether the enforcement remedy proposed is reasonable.

**C.  Findings of Fact, Conclusions of Law, and Analysis**

My conclusions of law are set forth in bold text followed by my findings of fact and analysis.  I have carefully considered all the evidence and the arguments of both parties, although not all may be specifically discussed in this decision.  I discuss the credible evidence given the greatest weight in my decision-making.6   I also discuss any evidence that I find is not credible or worthy of weight.  The fact that evidence is not specifically discussed should not be considered sufficient to rebut the presumption that I considered all the evidence and assigned such weight or probative value to the credible evidence that I determined appropriate within my discretion as an ALJ.  There is no requirement for me to discuss the weight given every piece of evidence considered in this case, nor would it be consistent with notions of judicial economy to do so.  Charles H. Koch, Jr., *Admin. L. and Prac.* § 5:64 (3d ed. 2013).

I conclude, based on the following findings of fact and analysis, that:

CMS made a prima facie showing that Petitioner violated 42 C.F.R. §§ 483.12 (Tag F600,7  scope and severity (s/s) J8 ) and 483.25(d) (Tag F689, s/s J) and each violation posed a risk for more than minimal harm;

Page 9

Petitioner has not rebutted the CMS prima facie showing or established an affirmative defense as to the allegations of noncompliance under Tags F600 or F689 by a preponderance of the evidence;

Petitioner has not shown that the declaration of immediate jeopardy and the duration of immediate jeopardy is clearly erroneous for the noncompliance cited under Tags F600 and F689; and

The proposed enforcement remedies are reasonable based on the noncompliance cited under Tags F600 and F689.

**1.  Petitioner violated 42 C.F.R. § 483.12 as alleged under Tag F600.**

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**2.  The violation of 42 C.F.R. § 483.12 posed a risk****for more than minimal harm****.**

**3.  Petitioner violated 42 C.F.R. § 483.25(d) as alleged under Tag F689.**

**4.  The violation of 42 C.F.R. § 483.25(d) posed a risk for more than minimal harm.**

**a.  Facts**

The allegations of noncompliance under Tags F600 and F689 involve the same residents – Residents 1 and 2.

(i)  Resident 1

Resident 1 was 63 years old at the time of the survey.  He was first admitted to Petitioner’s facility in January 2018 and readmitted on October 14, 2019.  His diagnoses included a history of cardiac arrest, acute respiratory failure without hypoxia, dysphagia, cognitive communication defect, Alzheimer’s disease, dementia with behavioral disturbance, lack of coordination, muscle wasting and atrophy, unsteadiness on his feet, muscle weakness.  CMS Ex. 4 at 1-6.  Resident 1’s care plan listed that he had impaired cognitive function or thought processes due to his Alzheimer’s and dementia.  The care plan indicated that he understood consistent, simple, directive sentences.  The care plan required that he be given cues, reoriented, and supervised as needed.  CMS Ex. 4 at 30.  Resident 1 was noted to be almost entirely nonverbal with occasional use of single words but generally he did not respond but just giggled.  CMS Ex. 4 at 13-14, 19, 21, 43, 48.

Resident 1’s care plan initiated on August 15, 2018, and updated on January 10, 2019, noted that he resided on the memory care unit due to wandering and elopement risk resulting from his Alzheimer’s and dementia.  The care plan stated that wandering was Resident 1’s normal behavior.  The goal stated in the care plan was to maintain the resident’s safety.  Interventions dated August 15, 2018, included assessing for fall risk, distracting the resident from wandering through diversions he favored, and monitoring for fatigue and weight loss.  CMS Ex. 4 at 35.  Implicit in the care plan is the need to monitor the resident and then supervise the resident to implement the distraction intervention.

A care plan initiated on August 15, 2018, focuses on Resident 1’s risk for falling due to poor safety awareness.  An intervention from August 15, 2018, indicates that Resident 1’s call light must be within reach, the resident should be encouraged to use the call light, and a prompt response to all requests for assistance was necessary.  This intervention highlights the need for monitoring of Resident 1.  Other interventions from August 15, 2018, include ensuring Resident 1 wore appropriate footwear for walking, and physical

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therapy evaluation and treatment.  CMS Ex. 4 at 36.  The footwear intervention required that Resident 1 be monitored for wandering with the appropriate footwear and then supervision to ensure proper footwear was used.

A care plan initiated on August 15, 2018, and updated on May 16, 2019, listed as a focus that Resident 1 had little or no activity involvement because he could not stay focused and tended to wander in and out of activities.  An intervention dated August 15, 2018, states that Resident 1 needed “assistance/escort to activity functions.”  CMS Ex. 4 at 37.  This care plan and the intervention reflect that in August 2018, Resident 1 required monitoring and supervision of his wandering to get him to and keep him at activities.

A care plan initiated on March 12, 2019, and revised on September 30, 2019, addressed Resident 1’s elopement risk and the risk for his injury due to impaired safety awareness.  The care plan stated that Resident 1 wandered in and out of other resident’s rooms which has resulted in resident-to-resident altercations.  The care plan listed three incidents.  One incident on an unspecified date involved Resident 1 wandering into another resident’s room and that resident grabbed Resident 1 by the neck and pushed him to the floor.  The second incident occurred on April 24, 2019, when Resident 1 wandered into another resident’s room and lay on the other resident’s bed and that resident hit Resident 1.  The third incident, that occurred in 2019 (the rest of the date is obscured in the copy of the document in evidence), when Resident 1 wandered into another resident’s room and Resident 1 was slapped in the face by the other resident.  It is surprising that, despite the three incidents listed in the new care plan, which was initiated on March 12, 2019, and revised on September 30, 2019, the interventions listed are no different than the interventions adopted in the care plans first adopted August 15, 2018, i.e., assessing Resident 1 for fall risk, ensuring proper footwear, and distracting him from wandering by pleasant diversion.  The care plan as revised on September 30, 2019, list additional interventions based on the three incidents listed in the care plan.  CMS Ex. 4 at 40.  It is important to note that the care plan revised on September 30, 2019, was adopted two months before the incidents in December 2019 and January 2020, which are the incidents cited by the surveyors in the SOD.  CMS Ex. 2 at 6-14.

The evidence includes three reports by Petitioner to the state agency reporting incidents involving Resident 1 and evidence from Petitioner’s records of other injuries suffered by Resident 1 in December 2019 and January 2020, which are the focus of the surveyors and CMS before me.

A provider investigation report by Petitioner to the state agency dated December 6, 2020, reported Petitioner’s investigation of an incident on December 1, 2019.  The incident occurred on December 1, 2019, at about 2:09 p.m. in Resident 1’s room.  The report indicates that Resident 1 suffered a small laceration to the top of his head of unknown origin.  Resident 1 was unable to explain what occurred or when.  Resident 1 was sent to the hospital, no sutures or staples were required, and a computed tomography scan (CT)

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was negative.  Another resident reported to Petitioner’s staff that he had seen Resident 1 quickly exiting another resident’s room following some yelling.  Staff received in-service training on Petitioner’s abuse policy; behavioral assessment, intervention, and monitoring; resident-to-resident altercations, and investigating injuries.  The report indicates no cause for the injury was determined.  CMS Ex. 4 at 16-18.  Petitioner’s December 1, 2020 self-report of the incident to the state is consistent with its provider investigation report.  Additional details included are that blood was found on Resident 1’s pillowcase and the laceration on his head was 1 to 1.5 inches long.  CMS Ex. 4 at 19-25.  According to a nursing note in an “SBAR Communication Form *and progress note*” dated December 1, 2019, at 3:50 p.m., another resident reported that he heard someone yelling at Resident 1 and he saw Resident 1 running from a room swinging his hands over his head like he was swatting flies.  One of Petitioner’s registered nurses opined that Resident 1 probably wandered into another resident’s room and was hit on the head with something.  P. Ex. 5 at 31.  I infer that Resident 1 was more likely than not hit on the head by another resident after wandering into that resident’s room.

Petitioner self-reported an incident on January 10, 2020.  According to the report, on January 10, 2020, at about 9:00 a.m. Resident 1 was found to have bruising around his left eye.  Resident 1 was unable to explain how the injury occurred.  An x-ray showed no facial bone fracture.  Staff received in-service training on Petitioner’s abuse policy and provider letter from July 2019 (no further description of the document is provided).  Petitioner reported the injury as being of unknown origin.  CMS Ex. 4 at 43-48.  However, in a self-report related to the January 29, 2020 incident discussed next, Petitioner reported that Resident 1 received a black eye from a different resident on January 10, 2020 as reported in its January 10, 2020 self-report of that incident.  CMS Ex. 4 at 14.
A progress note dated January 14, 2020, at 8:28 p.m. reported that Resident 1 had blood on his head following breaking a window in the dining room.  Staff reported that Resident 1 lost control and banged the window.  No source of the blood was identified however two subsequent notes indicate the resident suffered an injury to his face.  P. Ex. 5 at 11.

An “eINTERACT Change in Condition Evaluation” and a progress note dated January 26, 2020, at about 5:20 p.m. report that Resident 1 was found lying in bed with a small streak of blood on the left side of his face due to a 0.2 centimeter cut above his left eye and a skin tear on the bridge of his nose.  P. Ex. 5 at 9, 12.  Notes dated January 27, 28, and 29, 2020, indicate that Resident 1 may have suffered a fall with injuries.  P. Ex. 5 at 2-5.  A note dated January 27, 2020, at 12:12 p.m. indicates Resident 1 had a laceration above his left eyebrow, bruising around his eye and eye lid, and a skin tear on the bridge of his nose.  P. Ex. 5 at 4.  The evidence does not include a record that any fall with injuries or injuries of unknown source were reported to the state agency related to an incident on January 26 or 27, 2020, even though such a report is required by Petitioner’s

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policy (CMS Ex. 10 at 1, 20, 27, 29).  I infer that the injuries suffered by Resident 1 were more likely than not caused by an unwitnessed fall as reflected in progress notes. 
A self-report to the state agency by Petitioner dated January 29, 2020, reports an incident that occurred on that day.  According to the report, Resident 1 entered Resident 2’s room and got in Resident 2’s bed.  When Resident 2 entered his room, he pulled Resident 1 from his bed and hit him with his metal coffee cup.  Resident 1 was sent to the hospital.  Petitioner reported that it provided staff in-service training on Petitioner’s abuse and neglect policy, provider letter (no further description provided), and behavioral interventions.  CMS Ex. 4 at 13-15.  A January 29, 2020 report of a CT shows that Resident 1 suffered a left scalp laceration and hematoma but no internal injury.  CMS Ex. 4 at 12.  Petitioner’s provider investigation report to the state dated January 29, 2020, contained additional details.  The incident occurred on January 29, 2020, at approximately 4:40 p.m.  Petitioner characterized the incident as abuse.  Resident 2 who assaulted Resident 1 had a history of throwing a bottle of hot sauce at another resident and grabbing another resident by the elbow.  The report indicates that Resident 2 hit Resident 1 with his metal coffee cup on the top of Resident 1’s head.  The report indicates that Resident 1 suffered a laceration to his head that required seven staples, but the report later indicates that he required 12 staples.  Resident 2 was placed on one-on-one supervision while he remained at Petitioner until he could be transferred to another facility.  The report indicates that Resident 1 was transferred to another SNF for his safety.  CMS Ex. 4 at 8-11.

I have received no evidence that Petitioner’s care plans were updated by Resident 1’s IDT based on any of the incidents in December 2019 and January 2020.  CMS Ex. 4 at 40.

(ii)  Resident 2

Resident 2 was admitted to Petitioner’s facility on November 14, 2019.  He was 82 years old at the time of the survey.  His diagnoses included Alzheimer’s, dementia, depression, and a psychotic disorder with delusions due to a physiological condition.  CMS Ex. 5 at 1-2, 4-5, 25; P. Ex. 6 at 14, 35-37.  Resident 2’s care plan initiated on November 26, 2019, listed as a focus that Resident 2 had impaired cognitive function or impaired thought processes due to his Alzheimer’s disease.  CMS Ex. 5 at 19.  Resident 2’s care plan indicates that he resided on the secure unit because he was a wanderer and an elopement risk.  Interventions included that staff was to distract him from wandering by offering pleasant diversions, structured activities, food, conversation, television, and/or a book.  CMS Ex. 5 at 22.  Implicit in the care plan is the need to monitor Resident 2’s wandering and then providing supervision to distract him from wandering.

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On January 28, 2020, Resident 2 was belligerent with staff, yelling and cussing when a blood draw was attempted and later when the social worker attempted to visit with him.  P. Ex. 6 at 10.

Resident 2’s records show that on January 29, 2020, he hit Resident 1 on the head repeatedly with his metal coffee cup and his fists.  Resident 2 stated he hit Resident 1 because Resident 1 is a thief.  CMS Ex. 5 at 17; P. Ex. 6 at 9-10.  The evidence shows that Petitioner’s staff knew that sometimes Resident 1 wandered into Resident 2’s room, took Resident 2’s personal things, and would lie down in Resident 2’s bed.  CMS Ex. 5 at 16.

The evidence shows that after the assault on Resident 1 on January 29, 2020, Resident 2 was monitored or checked every 30 minutes on January 29, 30, and 31, 2020, and February 2 and 3, 2020.  CMS Ex. 5 at 26-30; P. Ex. 6 at 4-5, 7-8.

(iii) Petitioner’s Witnesses

Petitioner submitted as evidence the declaration of Kimberlee Hughett, RN, Petitioner’s director of nursing (DON).  DON Hughett testified that she was present at Petitioner on January 29, 2020, when Resident 2 hit Resident 1.  She testified that at the time of the incident a single CNA was dedicated to the secured unit where Residents 1 and 2 lived.  Resident 2 attacked Resident 1 at a time when the CNA assigned to the secure unit had left the unit to escort another resident outside the unit.  She testified that it took only minutes for the two residents to be separated, evaluated for injuries, their injuries attended to, and the investigation begun.  She testified that Petitioner ensured that at least one staff member was always on the secured unit.  However, she did not state when Petitioner started ensuring a staff member was always present on the secure unit and she did not testify a second staff member was present when the CNA left the secure unit on January 29, 2020, and Resident 2 attacked Resident 1.  She also was clear that the staff member present on the secured unit was not always medically trained.  She included a housekeeper as the example of a staff member who might be alone on the unit.  She did not explain how a housekeeper was trained or qualified to attend directly to residents to keep them safe or provide other necessary supervision.  P. Ex. 8 at 2.

Petitioner also submitted the declaration of Rebecca Anderson, RN, Petitioner’s chief clinical officer and DON Hughett’s supervisor.  RN Anderson opined that Petitioner’s staffing level was adequate.  She also opined that there was no risk for serious harm to any resident during the period February 6 through 15, 2020.  P. Ex. 9.  I do not reject RN Anderson’s opinion that Petitioner’s staffing level was adequate.  However, even if the staff level was adequate, the evidence does not show that the staff was providing the monitoring and supervision that both Residents 1 and 2 required.  RN Anderson did not state the basis for her opinion that there was no risk for serious harm or why she limited

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that opinion to the period February 6 through 15, 2020.  Without a stated basis for her opinion and the limitations on that opinion, the opinion is not weighty.

(iv)  Petitioner’s Abuse Policy

Petitioner had an abuse and neglect policy that directed staff on the protocols and procedures to follow to prevent and report abuse.  CMS Ex. 10.  The abuse policy specifically acknowledged that residents have the right to be free from any type of abuse, including willful infliction of physical injury from other residents.  CMS Ex. 10 at 24, 33, 38, 40.  Petitioner’s policy provided that staff was to be trained in abuse intervention and prevention, including recognizing signs of abuse and neglect.  CMS Ex. 10 at 41.

**b.  Analysis**

(i)  Tag F600 – Prima Facie Showing of Violation of 42 C.F.R. § 483.12

The surveyors allege in the SOD under Tag F600 that Petitioner violated 42 C.F.R. § 483.12(a) because Petitioner failed to “ensure [Residents 1 and 2] were free from abuse and neglect.”  CMS Ex. 2 at 6.  The regulation cited by the surveyors provides:

The resident has the right to be free from abuse, neglect, misappropriation of resident property, and exploitation as defined in this subpart.  This includes but is not limited to freedom from corporal punishment, involuntary seclusion and any physical or chemical restraint not required to treat the resident’s medical symptoms.

(a) The facility must—

(1) Not use verbal, mental, sexual, or physical abuse, corporal punishment, or involuntary seclusion;

42 C.F.R. § 483.12(a)(1).  The focus of the section if read literally is the prohibition of conduct by a facility staff.  The section does not specifically address protecting residents from abuse by others, either other residents or nonresidents.  However, a facility’s obligation to prevent abuse and neglect is made clearer by 42 C.F.R. § 483.12(b)(1), which provides:

(b) The facility must develop and implement written policies and procedures that:

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(1) **Prohibit and prevent** abuse, neglect, and exploitation of residents and misappropriation of resident property[.]

42 C.F.R. § 483.12(b)(1) (emphasis added).  The section is not limited to facility staff and imposes a broad requirement to prohibit and prevent all abuse, neglect, exploitation, and misappropriation.  Therefore, 42 C.F.R. § 483.12(a)(1) and (b)(1) clearly establish the participation requirement that a SNF, such as Petitioner, must protect its residents from abuse, neglect, exploitation, and misappropriation caused by anyone and the SNF must have policies in place to accomplish that requirement.  There is no dispute that Petitioner had adopted multiple policies that addressed abuse and neglect.  CMS Ex. 10 at 1-4, 20-21, 24-30, 33-46.  One of Petitioner’s abuse policies provided that “[r]esidents will not be subjected to abuse by anyone, including, but not limited to community staff, other residents, consultants, volunteers, staff or other agencies serving the residents, family members or legal guardians, caretaker, friends, or other individuals.” CMS Ex. 10 at 24 28, 33-37, 40-44.  Petitioner’s policies prohibiting abuse and neglect are consistent with the participation requirement established by 42 C.F.R. § 483.12.

Petitioner had a specific policy that addressed resident-to-resident abuse.  The policy required staff to monitor residents for aggressive or inappropriate behavior directed at other residents’ staff, family, and visitors.  The policy specified certain immediate interventions if residents became involved in an altercation.  CMS Ex. 10 at 20-21, 45-46.  Implicit in this policy is the requirement for staff to actual monitor residents and to intervene and supervise as necessary.

Petitioner also had a specific policy that listed resident rights, including the right to be free from abuse, neglect, misappropriation of their property, and exploitation.  CMS Ex. 10 at 38-39.

Abuse is defined in the federal regulations as follows:

*Abuse* is the willful infliction of injury, unreasonable confinement, intimidation, or punishment with resulting physical harm, pain or mental anguish.  Abuse also includes the deprivation by an individual, including a caretaker, of goods or services that are necessary to attain or maintain physical, mental, and psychosocial well-being.  Instances of abuse of all residents, irrespective of any mental or physical condition, cause physical harm, pain or mental anguish.  It includes verbal abuse, sexual abuse, physical abuse, and mental abuse including abuse facilitated or enabled through the use of technology.  Willful, as used in this definition of abuse, means the individual must have acted deliberately, not

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that the individual must have intended to inflict injury or harm.

42 C.F.R. §§ 483.5, 488.301 (emphasis in original).

Neglect is defined as:

*Neglect* is the failure of the facility, its employees or service providers to provide goods and services to a resident that are necessary to avoid physical harm, pain, mental anguish, or emotional distress.

42 C.F.R. §§ 483.5, 488.301 (emphasis in original).

Petitioner’s policies regarding abuse and neglect contain definitions of abuse and neglect that are not as detailed as the definitions established in 42 C.F.R. § 488.301.  CMS Ex. 10 at 3, 7, 24, 33, 40.  Therefore, it is at least arguable that Petitioner’s policies do not meet the requirement of 42 C.F.R. § 483.12(b), because the definitions of abuse and neglect in Petitioner’s policies are not as extensive as the definitions of abuse and neglect that must be prohibited under the federal regulations.  However, the surveyors did not cite Petitioner’s policies as being noncompliant and CMS does not raise that issue before me as a basis for finding Petitioner noncompliant with program participation requirements.

Care and services are supposed to be delivered to SNF residents according to the residents’ care plans.  42 C.F.R. § 483.21.  A resident’s care plan, such as the care plans in evidence for Resident 1, must be prepared by an interdisciplinary team (IDT) composed of the resident’s attending physician, a registered nurse with responsibility for the resident, a nurse aide with responsibility for the resident, a member of the food and nutrition staff, the resident or the resident’s representative (if practicable), and other appropriate staff or professionals based on the resident’s needs or if requested by the resident or the resident’s representative.  The care plan must be reviewed and revised by the IDT.  42 C.F.R. § 483.21(b)(2).  The care plan must be person-centered, i.e., the care plan must “meet a resident’s medical, nursing, and mental and psychosocial needs that are identified in the comprehensive assessment” of the resident.  42 C.F.R. § 483.21(b)(1).  Services provided under the comprehensive care plan must meet professional standards of quality and be provided by qualified persons in accordance with the written plan of care.  42 C.F.R. § 483.21(b)(3).

Resident 1 was admitted to Petitioner in January 2018 and readmitted on October 14, 2019.  CMS Ex. 4 at 1-6.  Resident 1’s IDT created a care plan that was initiated on August 15, 2018, and updated on January 10, 2019, following his readmission to Petitioner.  The IDT recognized that wandering was normal behavior for the resident.  The IDT identified the goal of keeping the resident safe.  Staff was instructed to distract

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Resident 1 from wandering by diversions.  CMS Ex. 4 at 35.  Although not specifically stated, it is implicit that staff had to be present to monitor and supervise Resident 1 and to implement the distraction intervention.  Some may consider monitoring to be a passive surveillance of a resident without active supervision involving direct contact and interaction with the resident.  Others may treat the terms monitoring and supervision as synonymous.  In this case, the IDT-adopted intervention of distracting Resident 1 from wandering clearly requires direct contact and interaction between the resident and staff.  To adequately implement the distraction-intervention, staff needed to monitor and observe Resident 1’s activity and then supervise the activity by intervening and offering distraction.  Therefore, the intervention included both monitoring and supervision.  The IDT also implemented on August 15, 2018, a fall risk care plan.  Staff was to ensure that the resident’s call light was in reach, that he was encouraged to use it, and prompt response to all assistance requests was directed.  Staff was also to ensure Resident 1 wore appropriate footwear for walking.  CMS Ex. 4 at 36.  It is implicit in the ordered interventions that staff needed to be present, monitor, and supervise Resident 1 to implement the interventions of the care plan.

The IDT developed and implemented a care plan for Resident 1 that was initiated on March 12, 2019, and revised on September 30, 2019, to address Resident 1’s elopement risk and risk for injury due to his impaired safety awareness.  The IDT stated in the care plan that the resident’s wandering in and out of other resident’s rooms had resulted in resident-to-resident alterations.  The IDT specifically listed in the care plan three incidents, which I infer occurred prior to the revision of the care plan on September 30, 2019.  The first incident on an unspecified date involved Resident 1 wandering into another resident’s room and the resident of that room grabbed Resident 1 by the neck and pushed him to the floor.  The second incident occurred on April 24, 2019, when Resident 1 wandered into another resident’s room where he lay on the bed and the resident of that room hit Resident 1 on the head.  The third incident, which occurred sometime prior to September 30, 2019, involved Resident 1 wandering into another resident’s room and being slapped by the other resident.  The IDT again adopted the intervention that staff was to distract Resident 1 from wandering through pleasant diversions.  CMS Ex. 4 at 40.  The evidence shows that no later than September 30, 2019, Resident 1’s IDT and Petitioner’s staff knew that Resident 1’s wandered into other residents’ rooms, and he had been physically abused at least three times.  Moreover, Resident 1’s IDT and Petitioner’s staff should have known that he required monitoring and supervision so that staff could distract him from wandering into other residents’ rooms where he was subject to being physically abused.  In fact, Petitioner’s resident-to-resident abuse policy specifically required that staff monitor residents for aggressive or inappropriate behavior directed at other residents’ staff, family, and visitors.  CMS Ex. 10 at 20-21, 45-46.  Implicit in the requirement for monitoring is the need for staff to be present and able to conduct monitoring and supervision if aggressive or inappropriate behavior occurred.

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The evidence shows that after September 30, 2019, there were multiple instances where Resident 1 was injured, and some instances involved resident-to-resident abuse.

The evidence shows that on December 1, 2019, Resident 1 was found in his room with a small laceration on top of his head.  Although Petitioner reported the incident as an injury of unknown origin, the evidence shows that another resident reported to Petitioner’s staff that he saw Resident 1 quickly exiting another resident’s room swinging his hands over his head following some yelling.  CMS Ex. 4 at 16-18, 19-25; P. Ex. 5 at 31.  The evidence shows it is more likely than not that Resident 1 was seen quickly exiting the other resident’s room and swing his hands over his head to ward off other blows like the one that likely caused the laceration on top of his head.

On January 10, 2020, Resident 1 suffered a black eye.  Petitioner reported the injury as being of unknown origin.  CMS Ex. 4 at 43-48.  However, in a subsequent report Petitioner stated that Resident 1 receive the black eye from another resident on January 10, 2020.  CMS Ex. 4 at 14.

On January 26, 2020, the evidence shows that Resident 1 was found lying in bed with a cut above his left eye and a skin tear on the bridge of his nose.  P. Ex. 5 at 4, 9, 12.  Subsequent progress notes show that Resident 1 fell and suffered the injuries.  P. Ex. 5 at 2-5.  Based on the evidence showing Resident 1 was found by staff in bed with the injuries, I infer that the fall that caused the injuries was unobserved.  Injuries of unknown source or a fall with injuries are supposed to be reported to the state agency under Petitioner’s policies and 42 C.F.R. § 483.12(c).  CMS Ex. 10 at 1, 20, 27, 29.  However, there is no report to the state agency in evidence that reveals the results of the investigation of the injuries.  These facts arguably reflect noncompliance with the program participation requirement established by 42 C.F.R. § 483.12(c), but neither the state surveyors nor CMS cited this noncompliance, and it is not considered further.

The last incident occurred on January 29, 2020.  Resident 1 entered Resident 2’s room and Resident 1 lay on Resident 2’s bed.  Resident 2 beat Resident 1 with his metal coffee cup.  As a result, Resident 1 had to be transported to the hospital for treatment of a laceration on his head.  CMS Ex. 4 at 8-15.

Thus, the evidence shows that there were three incidents involving Resident 1 being injured by other residents in December 2019 and January 2020, and one incident of Resident 1 being injured by an unobserved fall.  There is no evidence in the record showing that Resident 1’s IDT reviewed Petitioner’s care plan after any of these incidents or implemented any new interventions to address his repeated abuse by other residents or his fall with an injury.  It is arguable based on the evidence that the IDT failed to review and revise Resident 1’s care plan as required by 42 C.F.R. § 483.21(b)(2).  The surveyors and CMS do not allege a care planning deficiency against Petitioner, and I do consider the care planning failure further.  However, when the four incidents occurred in

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December 2019 and January 2020, Resident 1’s care plans required that Resident 1’s safety be maintained by ensuring he wore appropriate footwear when walking and that he be distracted from wandering.  The interventions adopted by the IDT could not be implemented without monitoring and supervising of Resident 1’s activities.

Petitioner’s DON, RN Hughett, admitted in her testimony that on January 29, 2020, when Resident 1 was attacked by Resident 2, there was only one staff member, a CNA, assigned to the hall where the incident occurred.  When Resident 1 was abused by Resident 2 the CNA was off the unit to escort another resident.  P. Ex. 8 at 2.  Therefore, Resident 1 was not monitored or supervised when he was abused by Resident 2 while the CNA was absent from the hall.

The evidence shows it is more likely than not that the injuries suffered by Resident 1 on December 1, 2019, January 10, 2020, and January 26, 2020, were unobserved by Petitioner’s staff.  Therefore, I infer that Resident 1 was not monitored or supervised by staff when these three incidents and/or accidents occurred.

The care plan revised on September 30, 2019, does not indicate whether the three incidents of abuse of Resident 1 were observed by staff or whether he was being monitored or supervised when those incidents occurred.  CMS Ex. 4 at 40.  However, those incidents are not the basis for the noncompliance cited by the surveyor and pursued by CMS before me.  CMS Ex. 2 at 6-7.

I conclude CMS has made a prima facie showing that Petitioner violated 42 C.F.R. § 483.12 because Petitioner failed to prevent the abuse of Resident 1 because Petitioner failed to implement the care planned interventions that required monitoring and supervision of Resident 1 when he wandered to keep him safe from falls or abuse by other residents.  I further conclude that there has been a prima facie showing that Resident 1 was neglected, also in violation of 42 C.F.R. § 483.12, because the necessary care and services to keep Resident 1 safe from abuse by other residents, i.e., the care planned interventions that required monitoring and supervision, were not provided to him.  The violations posed a risk for more than minimal harm as the evidence shows that Resident 1 suffered actual harm.

(ii)  Tag F689 – Prima Facie Showing of Violation of 42 C.F.R. § 483.25(d)(2)

I also conclude based on the same facts that Petitioner violated 42 C.F.R. § 483.25(d)(2) because Petitioner failed to ensure that Resident 1 received adequate supervision to prevent him from being injured by other residents who physically abused him.

A SNF is required to ensure that each resident receives adequate supervision and assistance devices to prevent accidents.  42 C.F.R. § 483.25(d)(2).  The term supervision

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is not defined in the regulations that establish participation requirements for long-term care facilities or procedures for survey, certification, and enforcement of participation requirements.  However, supervision was described as follows by the SOM in effect when Resident 1’s care plans were developed, and the incidents of abuse and accidents occurred in this case.

*“Supervision/Adequate Supervision” refers to an intervention and means of mitigating the risk of an accident.  Facilities are obligated to provide adequate supervision to prevent accidents.  Adequate supervision is determined by assessing the appropriate level and number of staff required, the competency and training of the staff, and the frequency of supervision needed.  This determination is based on the individual resident’s assessed needs and identified hazards in the resident environment.  Adequate supervision may vary from resident to resident and from time to time for the same resident.*

SOM, app. PP, Tag F689 rev. 173 (eff. Nov. 28, 2017) (italics in original).  According to CMS, an accident is “any unexpected or unintentional incident, which results or may result in injury or illness to a resident.”  *Id.*An avoidable accident according to CMS is one that occurs because, among other things, a SNF failed to “implement interventions, including adequate supervision . . . , consistent with a resident’s needs, goals, care plan, and current professional standards of practice,” to eliminate or reduce the risk of an accident.  *Id.*

The IDT’s care plans for Resident 1 required that:  he be distracted from wandering; his call light be in reach; he be encouraged to use his call light; staff promptly respond to his call light; he wear adequate footwear for walking; and he be assisted and/or escorted to activities.  CMS Ex. 4 at 35-37, 40.  None of these interventions created by the IDT can be effectively implemented unless Resident 1 was monitored and supervised.  Further due to the limited interventions adopted by the IDT to prevent Resident 1 from being abused by other residents when he wandered, it was critically important to ensure that Resident 1 was adequately supervised by staff as required by 42 C.F.R. § 483.25(d)(2) to ensure that he did not suffer injury due to abusive assaults by other residents and possible falls.

Petitioner failed to effectively implement Resident 1’s care plan and failed to provide supervision to prevent accidental injury of Resident 1 due to falling or assaults by other residents as required by 42 C.F.R. § 483.25(d)(2).  Petitioner’s records in evidence show at least three incidents of abuse of Resident 1 prior to September 19, 2019, and three incidents of resident abuse of Resident 1 and a fall with injuries in December 2019 and January 2020.  The four incidents in December 2019 and January 2020, all resulted in actual harm to Resident 1, which is more than minimal harm.  Accordingly, I conclude

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CMS made a prima facies showing of noncompliance with the requirement of 42 C.F.R. § 483.25(d)(2).

(iii)  Petitioner’s Arguments

Petitioner addresses the noncompliance alleged under Tags F600 and F689 together.

Petitioner argues that there is no minimum staffing level required by regulation.  Petitioner also argues that there is no requirement that secure units be staffed so that all residents are subject to constant observation.  P. Prhg. Br. at 16; P. Br. at 6.  Petitioner is correct that federal participation requirements in 42 C.F.R. pt. 483 and the Act do not specify a minimum number of staff or require that staff be sufficient to permit constant observation or supervision of all residents whether on a secure unit or not.  However, Petitioner is required to ensure that it has sufficient nursing staff with the right competencies and skills necessary to provide nursing and related services for residents, to assure their safety and maintain their highest state of well-being (physical, mental, and psychosocial), as required by the residents’ plans of care.  42 C.F.R. § 483.35.  Petitioner is required to provide on a 24-hour basis, sufficient staff (nurses and nurse aides) to provide nursing care required by all residents in accordance with their care plans.  42 C.F.R. § 483.35(a)-(c).

The allegations of noncompliance under Tags F600 and F689 in this case are that Petitioner failed to provide Resident 1 the monitoring and supervision required by his care plan and the regulation to keep him safe from falls and while wandering.  The allegations are not, as Petitioner suggests, about counting staff on duty or whether they were attending to their duty.  The three incidents listed in Resident 1’s care plan and the four incidents in December 2019 and January 2020, show that regardless of how many staff were on duty Resident 1 was still being injured by falls or attacks by other residents when he was wandering.  The incidents show Resident 1 was not receiving the monitoring and supervision his IDT directed in his care plan or as required by the regulation to prevent accidental injury.

Petitioner suggests that housekeeping staff could provide supervision.  P. Prhg. Br. at 17; P. Br. at 7.  However, 42 C.F.R. § 483.35 is clear that nursing staff must deliver nursing care and services.  Petitioner has not shown that Resident 1’s care plan requirements to monitor and distract him from wandering and ensure he wore proper footwear are not nursing interventions under current standards of care or that such interventions may be implemented by staff other than nurses or nurse aides.

Petitioner asserts that staff could adequately monitor the hall through the windows while outside supervising smokers or working on their electronic devices.  P. Prhg. Br. at 17; P. Br. at 7.  I accept that staff looking through the widows or looking up from their electronic devices might see the hallway of the unit where Resident 1 resided.  However,

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it is self-evident those staff could only see where they were looking.  Petitioner has not presented evidence sufficient to show that those staff could more likely than not see into the rooms where Resident 1 wandered, lay on a bed, and was beaten or choked by other residents.  The number of unobserved or unwitnessed injuries Resident 1 suffered is consistent with my inference that no one was looking (monitoring, observing, or supervising) when he was injured.

Petitioner argues that there is no “causal connection between staffing levels and potential harm.”  P. Prhg. Br. at 17; P. Br. at 7-8; P. Reply at 4-5; P. Ex. 8 at 2-3; P. Ex. 9 at 1-2.  Petitioner illustrates this argument referring to two incidents that occurred that were reviewed by surveyors but not cited as examples of noncompliance.  Both incidents involved resident-to-resident physical abuse with injuries and both incidents occurred while observed by staff.  Petitioner asserts that even with staff providing constant monitoring incidents still happen.  P. Prhg. Br. at 17.  I accept as true that even with one-to-one supervision of residents by staff an accident or abuse may still occur.  However, these examples and Petitioner’s arguments are not evidence that show that Petitioner was ensuring that Resident 1’s care plan was implemented or that he received the supervision required by the regulation to minimize the risk for accidents or relate injuries.

Petitioner argues, citing to the SOM, that an impermissible “stacking of charges” occurred in this case because the surveyors cited noncompliance under both Tags F600 and F689 based on the same facts related to Resident 1.  Petitioner also argues that the noncompliance alleged cannot be cited as both abuse and an accident.  P. Prhg. Br. at 17-18; P. Br. at 8-9; P. Reply at 5-6.  CMS has instructed surveyors in the SOM that noncompliance cited under one regulation or Tag does not automatically trigger a citation of noncompliance with other regulations.  The only reasonable interpretation of this guidance is that each allegation of noncompliance must stand on its own merit.  My interpretation is consistent with the further CMS guidance to surveyors that if the surveyor team makes multiple citations of noncompliance based on the same facts, the survey team must state how the facts show a distinct violation of each regulation or Tag.  It is not my task is not to review the adequacy of the surveyors’ performance or the quality of the drafting of the SOD.9   *Avon Nursing Home*, DAB No. 2830 at 11-12 (2017).  However, in this case, there is no issue the surveyors performed as instructed by

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CMS.  The surveyors clearly articulate in the SOD how the facts constituted a violation of the two regulations cited under Tags F600 and F689.  The surveyors described in detail the examples they identified that resulted in the violations and the risk for more than minimal harm.  CMS Ex. 2 at 6-49.  Petitioner’s assertion that multiple allegations of noncompliance cannot be based on the same facts is unsupported by any citation of legal authority.  Further, the regulatory participation requirements impose distinct requirements upon Petitioner, and both requirements were violated in the example of Resident 1.  The noncompliance cited based on violation of 42 C.F.R. § 483.12 is related to Resident 1’s right to be free from abuse and neglect and Petitioner’s obligation to have and implement policies to protect Resident 1 from abuse and neglect.  Under 42 C.F.R. § 483.25(d)(2), Petitioner must minimize the risk for accidents and related injuries by ensuring its residents receive adequate supervision and assistance.  CMS has made a prima facie showing that Petitioner failed to protect Resident 1 from being abused and neglected and Petitioner failed to provide adequate supervision to prevent Resident 1 from sustaining accidental injuries.  Petitioner has not met its burden to show by a preponderance of the evidence, i.e., that it is more likely than not, that it did comply with Resident 1’s care plan and the regulatory requirement to provide Resident 1 necessary monitoring and supervision.

Petitioner has also failed to show by a preponderance of the evidence that it corrected the noncompliance cited under Tags F600 and F689 prior to March 11, 2020, the date the state agency and CMS determined Petitioner returned to substantial compliance with program participation requirements.  CMS Ex. 1 at 1.  The surveyors declared immediate jeopardy based on the noncompliance cited under Tags F600 and F689.  CMS Ex. 2 at 6-7, 28-29.  The surveyors determined immediate jeopardy was removed as to both Tags F600 and F689 as of February 15, 2020.  However, they also determined that Petitioner remained out of substantial compliance and the noncompliance continued at a scope and severity level of isolated actual harm because Petitioner had to monitor its plan of removal for effectiveness.  CMS Ex. 2 at 7, 29.  DON Hughett testified in her declaration that on February 13, 2020, Petitioner added a second CNA to each secured unit, trained staff regarding having someone always monitor the halls, and trained staff regarding abuse and neglect and how to handle resident-to-resident altercations.  DON Hughett testified no other actions were taken by Petitioner on February 14 and 15, 2020.  P. Ex. 8 at 2.  The SOD indicates that as of February 13, 2020, both Residents 1 and 2 were no longer residing at Petitioner.  The SOD confirms that staff was changed on the secured units and that training was being provided.  The SOD states that corrective action was completed as of 5:11 p.m. on February 13, 2020.  However, the SOD states that the surveyors refused to find immediate jeopardy was removed prior to February 15, 2020, because their observation were that the halls were not adequately supervised, and staff was attending to their cell phones rather than supervising the halls.  CMS Ex. 2 at 25-27, 47-49.

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Neither DON Hughett nor the surveyors address any correction of Petitioner’s failure to monitor or supervise Resident 1 or any other resident who had IDT-adopted interventions to address wandering and risks to their safety from accident hazards or resident-to-resident abuse when they wandered or failed to wear adequate footwear.  While keeping hallways under observation by attentive staff may have been a step in the right direction, the act of observing the hallways does not address the specific interventions of distracting Resident 1 or ensuring he had adequate footwear to keep him safe from falls and resident-to-resident abuse.  Therefore, the evidence before me, while supporting the determination to lift immediate jeopardy on February 15, 2020, does not show it more likely than not that Petitioner actually corrected its noncompliance under Tags F600 and F689, even as of March 11, 2020.  Nevertheless, I will not disturb the CMS determination that Petitioner did return to substantial compliance on March 11, 2020.

**5.  Petitioner failed to meet its burden to show that CMS’s determination of immediate jeopardy from****February 6 through 15, 2020, related to the noncompliance under 42 C.F.R. §§ 483.12 (Tag F600) and 483.25(d) (Tag F689), was clearly erroneous.**

The surveyors alleged that the noncompliance cited under Tags F600 and F689 posed immediate jeopardy to Petitioner’s residents.  CMS Ex. 1 at 1; CMS Ex. 2 at 6-7, 28-29.  CMS determined that immediate jeopardy began on February 6 and continued through February 15, 2020.  CMS imposed a CMP of $14,659 for each day of immediate jeopardy level noncompliance.  CMS Ex. 1 at 2.; CMS Ex. 2 at 1.

Petitioner argues that there was no immediate jeopardy, but if there was, it was abated not later than February 13, 2020.  P. Prhg. Br. at 18-21; P. Br. at 9-13; P. Reply at 6-8.

The CMS determination of immediate jeopardy must be upheld unless Petitioner shows the declaration of immediate jeopardy to be clearly erroneous.  42 C.F.R. § 498.60(c)(2).  CMS’s determination of immediate jeopardy is presumed to be correct, and Petitioner has a heavy burden to demonstrate clear error in that determination.  *Yakima Valley Sch.*, DAB No. 2422 at 8-9 (2011); *Cal Turner Extended Care Pavilion*, DAB No. 2384 at 14 (2011); *Brian Ctr. Health and Rehab./Goldsboro,*DAB No. 2336 at 9 (2010) (citing *Barbourville Nursing Home*, DAB No. 1962 at 11 (2005), *aff’d*,*Barbourville Nursing Home v. U.S. Dep’t of Health & Human Srvs.,*174 F. App’x 932 (6th Cir. 2006)); *Maysville Nursing and Rehab. Facility*, DAB No. 2317 at 11 (2010); *Liberty Commons Nursing & Rehab. Ctr.– Johnston*, DAB No. 2031 at 18-19, *aff’d*,*Liberty Commons Nursing & Rehab. Ctr.–Johnson v. Leavitt*, 241 F. App’x 76 (4th Cir. 2007).  “Once CMS presents evidence supporting a finding of noncompliance, CMS does not need to offer evidence to support its determination that the noncompliance constitutes immediate jeopardy, rather, the burden is on the facility to show that that determination is clearly erroneous.”  *Cal Turner*, DAB No. 2384 at 14-15 (citing *Liberty Commons Nursing & Rehab. Ctr.–Johnston*, 241 F. App’x 76 at 3-4).

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“*Immediate jeopardy”* under the regulations refers to a situation in which the provider’s noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident.”  42 C.F.R. §§ 488.301, 489.3 (emphasis in original).  In the context of survey, certification, and enforcement related to SNFs and NFs under the regulations, a conclusion by the state agency and CMS that noncompliance with program participation requirements poses immediate jeopardy to the facility residents, triggers specific regulatory provisions that require enhanced enforcement remedies, including authority for CMS to impose a larger CMP than may be imposed when there is no declaration of immediate jeopardy.  42 C.F.R. §§ 488.408(e); 488.438(a)(1)(i), (c), and (d).  The regulations also require termination of the facility’s provider agreement on an expedited basis or the removal of the immediate jeopardy through appointment of temporary management.  42 C.F.R. §§ 488.410, 488.440(g), 488.456, 489.53(d)(2)(B)(ii).

Pursuant to 42 C.F.R. § 498.3(d)(10), a finding by CMS that deficiencies pose immediate jeopardy to the health or safety of a facility’s residents is not an initial determination that triggers a right to request a hearing by an ALJ or that is subject to review.  Rather, a finding of noncompliance that results in the imposition of an enforcement remedy, except the remedy of monitoring by the state, does trigger a right to request a hearing and is subject to review.  42 C.F.R. §§ 488.408(g); 498.3(b)(8), and (13).  Furthermore, the level of noncompliance, i.e., scope and severity, is subject to review only if a successful challenge would:  (1) affect the amount of CMP that may be imposed, i.e., the higher range of CMP authorized for immediate jeopardy; or (2) affect a finding of substandard quality of care that rendered the facility ineligible to conduct an NATCEP.  42 C.F.R. § 498.3(b)(14) and (16).  Pursuant to 42 C.F.R. § 498.60(c)(2), in reviewing a CMP, the ALJ must uphold the CMS determination of the level of noncompliance (i.e., the scope and severity), unless it is clearly erroneous.  The phrase “clearly erroneous” is not defined by the Secretary.

Many appellate panels of the Board have addressed “immediate jeopardy.”10   In *Mississippi Care Ctr. of Greenville*, DAB No. 2450 at 15 (2012), the Board commented:

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CMS’s determination that a deficiency constitutes immediate jeopardy must be upheld unless the facility is able to prove that the determination is clearly erroneous.  42 C.F.R. § 498.60(c)(2); *Woodstock Care Center*.  The “clearly erroneous” standard means that CMS’s immediate jeopardy determination is presumed to be correct, and the burden of proving the determination clearly erroneous is a heavy one.  *See, e.g.,* *Maysville Nursing & Rehabilitation Facility*, DAB No. 2317 at 11 (2010); *Liberty Commons Nursing and Rehab Center — Johnston*, DAB No. 2031 at 18 (2006), *aff’d*, *Liberty Commons Nursing and Rehab Ctr. — Johnston v. Leavitt*, 241 F. App’x 76 (4th Cir. 2007).  When CMS issued the nursing facility survey, certification, and enforcement regulations, it acknowledged that “distinctions between different levels of noncompliance . . . do not represent mathematical judgments for which there are clear or objectively measured boundaries.”  59 Fed. Reg. 56,116, 56,179 (Nov. 10, 1994).  “This inherent imprecision is precisely why CMS’s immediate jeopardy determination, a matter of professional judgment and expertise, is entitled to deference.”  *Daughters of Miriam Center*, DAB No. 2067, at 15 (2007).

The Board’s statement that the CMS immediate jeopardy determination is entitled to deference is subject to being misunderstood to limit ALJ and Board review of immediate jeopardy beyond what was intended by the drafters of the regulations.  In the notice of final rulemaking on November 10, 1994, the drafters of 42 C.F.R. § 498.60(c)(2), discussing the merits of the reviewability of deficiency citations, selection of remedy, and scope and severity, commented:

We believe that a provider’s burden of upsetting survey findings relating to the level of noncompliance should be high, however.  As we indicated in the proposed rule, distinctions between different levels of noncompliance, whether measured in terms of their frequency or seriousness, do not represent mathematical judgments for which there are clear or objectively measured boundaries.  Identifying failures in a facility’s obligation to provide the kind of high quality care required by the Act and the implementing regulations most often reflect judgments that will reflect a range of noncompliant behavior.  Thus, in civil money penalty cases, whether deficiencies pose immediate jeopardy, or are widespread and cause actual harm that is not immediate

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jeopardy, or are widespread and have a potential for more than minimal harm that is not immediate jeopardy does not reflect that a precise point of noncompliance has occurred, but rather that a range of noncompliance has occurred which may vary from facility to facility.  While we understand the desire of those who seek the greatest possible consistency in survey findings, an objective that we share, the answer does not lie in designing yardsticks of compliance that can be reduced to rigid and objectively calculated numbers.  Survey team members and their supervisors ought to have some degree of flexibility, and deference, in applying their expertise in working with these less than perfectly precise concepts.  **For these reasons, we have revised the regulations to require an administrative law judge or appellate administrative review authority to uphold State or HCFA findings on the seriousness of facility deficiencies in civil money penalty cases unless they are clearly erroneous.**

59 Fed. Reg. at 56, 116, 56,179 (Nov. 10, 1994) (emphasis added).  It is clear from this regulatory history that the drafters of 42 C.F.R. § 498.60(c)(2) ensured that the state agency or CMS determination that there was immediate jeopardy would receive deferential consideration by adopting the clearly erroneous standard of review.  Thus, caution must be exercised to ensure that the Board’s decision in *Mississippi Care Ctr. of Greenville*; *Daughters of Miriam Ctr.*, and other decisions that have mentioned deference relative to immediate jeopardy not be read to require deference for the determination that there was immediate jeopardy beyond that imposed by adoption of the clearly erroneous standard.  Giving deference or requiring that the immediate jeopardy determination be given deference in addition to applying the “clearly erroneous standard” would be contrary to the intent of the drafters of the regulation; would significantly limit the review of the determination by an ALJ and the Board; and would impermissibly deny an affected party the due process right to review intended by the drafters of the regulation.

In the foregoing quotation from *Mississippi Care Ctr. of Greenville*, that panel of the Board stated that the clearly erroneous standard means that “the immediate jeopardy determination is presumed to be correct, and the burden of proving the determination clearly erroneous is a heavy one.”  *Id*. at 15.  Similar formulations have been used in other Board decisions when referring to the “clearly erroneous standard.”  However, the Board’s characterization of the “clearly erroneous standard” in *Mississippi Care Ctr.* and other cases does not define the standard.  The “clearly-erroneous standard” is described in Black’s Law Dictionary as a standard of appellate review applied in judging the trial court’s treatment of factual issues, under which a factual determination is upheld unless the appellate court has the firm conviction that an error was committed.  *Black’s Law*

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*Dictionary* 269 (8th ed. 2004).  The Supreme Court has addressed the “clearly erroneous standard” in the context of the Administrative Procedures Act (APA).  The Court described the preponderance of the evidence standard, the most common standard, as requiring that the trier-of-fact believe that the existence of a fact is more probable than not before finding in favor of the party that had the burden to persuade the judge of the fact’s existence.  *In re Winship*, 397 U.S. 358, 371-72 (1970); *Concrete Pipe & Prods. of Cal., Inc. v. Constr. Laborers*, 508 U.S. 602, 622 (1993).  The “substantial evidence” standard considers whether a reasonable mind might accept a particular evidentiary record as adequate to support a conclusion.  *Consol. Edison*, 305 U.S. 197, 229 (1938); *Dickinson v. Zurko*, 527 U.S. 150, 162 (1999).  Under the “clearly erroneous” standard, a finding is clearly erroneous even though there may be some evidence to support it if, based on all the evidence, the reviewing judge or authority has a definite and firm conviction that an error has been committed.  *United States v. U.S. Gypsum Co.*, 333 U.S. 364, 395 (1948); *Dickinson*, 527 U.S. at 162; *Concrete Pipe*, 508 U.S. at 622.  The clearly erroneous standard has been characterized by the Court as being stricter than the substantial evidence test and significantly deferential.  The Court stressed in discussing the clearly erroneous standard the importance of not simply rubber-stamping agency fact-finding.  The Court also commented that the APA requires meaningful review.11 *Dickinson*, 527 U.S. at 162 (citations omitted); *Concrete Pipe*, 508 U.S. at 622-23.

Various panels of the Board have recognized other principles applicable to the review of the immediate jeopardy issue.  A finding of immediate jeopardy does not require a finding of actual harm, only a likelihood of serious harm.  *Dumas Nursing & Rehab., L.P.*, DAB No. 2347 at 19 (citing*Life Care Ctr. of Tullahoma*, DAB No. 2304 at 58 (2010), *aff’d, Life Care Ctr. of Tullahoma v. Sec’y of U.S. Dep’t of Health & Human Servs.*, 453 F. App’x 610 (6th Cir. 2011)).  The definition of immediate jeopardy at 42 C.F.R. § 488.301, does not define “likelihood” or establish any temporal parameters for potential harm.  *Agape Rehab. of Rock Hill*, DAB No. 2411 at 18-19 (2011).  The duration of the period of immediate jeopardy is also subject to the clearly erroneous standard.  *Brian Ctr. Health & Rehab./Goldsboro*, DAB No. 2336 at 7-8.  There is a difference between “likelihood” as required by the definition of immediate jeopardy and a mere potential.  The synonym for likely is probable, which suggests a greater degree of

Page 30

probability that an event will occur than suggested by such terms as possible or potential.  *Daughters of Miriam Ctr.*, DAB No. 2067 at 10.  Jeopardy generally means danger, hazard, or peril.  The focus of the immediate jeopardy determination is how imminent the danger appears and how serious the potential consequences.  *Woodstock Care Ctr.*, DAB No. 1726.

What is the meaning of serious injury, harm, or impairment as used in the definition of immediate jeopardy found in 42 C.F.R. § 488.301?  How does serious injury, harm, or impairment compare with “actual harm?”  On the first question the Board recognized in *Yakima Valley Sch.*, DAB No. 2422 at 8, that the regulations do not define or explain the meaning of the term “serious” as used in the definition of immediate jeopardy.  The Board suggested that the definitions may be unimportant because the Board has held that, under the clearly erroneous standard, once the state agency or CMS declares immediate jeopardy there is a presumption that the actual or threatened harm was serious and the facility can only rebut the presumption of immediate jeopardy by showing that the harm or threatened harm meets no reasonable definition of the term “serious.”  *Id.* (citing *Daughters of Miriam Ctr.*, DAB No. 2067 at 9).  In *Daughters of Miriam Ctr.*, the Board discussed that the ALJ attempted to define “serious,” finding meanings such as dangerous, grave, grievous, or life-threatening.  The Board notes that the ALJ stated that serious harm is outside the ordinary, requiring extraordinary care, or having lasting consequences.  The Board further noted that the ALJ stated that a serious injury may require hospitalization, or result in long-term impairment, or cause severe pain, as opposed to harm, injury, or impairment that is temporary, easily reversible with ordinary care, does not cause a period of incapacitation, heals without special medical intervention, or does not cause severe pain.  The Board did not endorse or adopt the ALJ’s definitional exercise but concluded that it was simply unnecessary in the context of that case.  The Board reasoned, as already noted, that the facility bore the burden to rebut the presumption by showing that the actual or threatened harm met no reasonable definition of serious.  *Daughters of Miriam Ctr.*, DAB No. 2067 at 9-10.

Applying the clearly erroneous standard to the record before me related to the noncompliance I have found based on the violations of 42 C.F.R. §§ 483.12 (Tag F600) and 483.25(d) (Tag F689), I have no definite and firm conviction that an error has been committed in declaring immediate jeopardy.  I conclude that Petitioner has failed to meet its burden to show that the determination of immediate jeopardy for the noncompliance cited under Tags F600 and F689 for the period February 6 through 15, 2020, was clearly erroneous.

The evidence shows that Resident 1 suffered actual harm due to resident-to-resident abuse and an unobserved fall.  Petitioner failed to prevent the resident-to-resident abuse of Resident 1 or to minimize the risk for Resident 1 from falling and suffering injury by neglecting to implement the resident’s IDT care planned interventions.  Petitioner’s evidence and arguments do not show that serious injury, under any definition of serious,

Page 31

or death due to Petitioner’s failure to implement Resident 1’s care plan and to provide the monitoring and supervision required by the IDT and the regulation was unlikely.
The surveyors determined immediate jeopardy was removed as to both Tags F600 and F689 as of February 15, 2020.  DON Hughett testified in her declaration that on February 13, 2020, Petitioner added a second CNA to each secured unit, trained staff regarding having someone always monitor the hall, and trained staff regarding abuse and neglect and how to handle resident-to-resident altercations.  DON Hughett testified no other actions were taken on February 14 and 15, 2020.  P. Ex. 8 at 2.  The SOD indicates that as of February 13, 2020, both Residents 1 and 2 were no longer residing at Petitioner.  The SOD confirms that staffing was changed on the secured units and that training was being provided.  The SOD states that corrective action was completed as of 5:11 p.m. on February 13, 2020.  However, the SOD states that the surveyors refused to find immediate jeopardy was removed prior to February 15, 2020, because their observation were that the halls were not adequately supervised, and staff was attending to their cell phones rather than supervising the halls.  The surveyors also found and concluded that Petitioner’s deficient practices could potentially have affected all its residents in secure units and placed them at risk for serious injury, harm, or death.  CMS Ex. 2 at 7, 25-27, 47-49.  Petitioner’s evidence of its efforts to abate the immediate jeopardy does not show clearly erroneous the surveyors’ findings and conclusions that immediate jeopardy continued through February 15, 2020

**6.****A CMP of $14,100 per day from February 6 through 15, 2020, and a CMP of $150 per day from February 16 through March 10, 2020, are reasonable enforcement remedies.**

I have concluded that Petitioner violated 42 C.F.R. §§ 483.12 (Tag F600), and 483.25(d) (Tag F689), Resident 1 suffered actual harm due to the violations, and the violations posed immediate jeopardy, i.e., a risk for serious injury, serious harm, serious impairment, or death to facility residents.  I have also concluded that Petitioner has failed to show that the determination of immediate jeopardy for noncompliance with the requirements of 42 C.F.R. §§ 483.12 (Tag F600), and 483.25(d) (Tag F689) during the period of February 6 through 15, 2020, was clearly erroneous.

If a facility is not in substantial compliance with program requirements, CMS has the authority to impose one or more of the enforcement remedies listed in 42 C.F.R. § 488.406, including a CMP.  CMS may impose a per-day CMP for the number of days that the facility is not in compliance, or a per-instance CMP for each instance that a facility is not in substantial compliance, whether or not the deficiencies pose immediate jeopardy.  42 C.F.R. § 488.430(a).  I conclude that there is a basis for the imposition of an enforcement remedy in this case, i.e., the noncompliance I have concluded existed.

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If I conclude, as I have in this case, that there is a basis for the imposition of an enforcement remedy and the remedy proposed is a CMP, my authority to review the reasonableness of the CMP is limited by 42 C.F.R. § 488.438(e).  The limitations are that I may:  (1) not set the CMP at zero or reduce it to zero; (2) not review the exercise of discretion by CMS in selecting to impose a CMP; and (3) only consider the factors specified by 42 C.F.R. § 488.438(f) when determining the reasonableness of the CMP amount.  In determining whether the amount of a CMP is reasonable, the following factors specified at 42 C.F.R. § 488.438(f) must be considered:  (1) the facility’s history of noncompliance, including repeated deficiencies; (2) the facility’s financial condition; (3) the seriousness of the deficiencies as set forth at 42 C.F.R. § 488.404(b), the same factors CMS and/or the state were to consider when setting the CMP amount; and (4) the facility’s degree of culpability, including but not limited to the facility’s neglect, indifference, or disregard for resident care, comfort, and safety, and the absence of culpability is not a mitigating factor.  The factors that CMS and the state were required to consider when setting the CMP amount and that I am required to consider when assessing the reasonableness of the amount are set forth in 42 C.F.R. § 488.404(b):  (1) whether the deficiencies caused no actual harm but had the potential for minimal harm, no actual harm with the potential for more than minimal harm, but not immediate jeopardy, actual harm that is not immediate jeopardy, or immediate jeopardy to resident health and safety; and (2) whether the deficiencies are isolated, constitute a pattern, or are widespread.

My review of the reasonableness of the CMP is de novo and based upon the evidence in the record before me.  I am not bound to defer to the CMS determination of the reasonable amount of the CMP to impose, but my authority is limited by regulation as already explained.  I am to determine whether the amount of any CMP proposed is within reasonable bounds, considering the purpose of the Act and regulations.  *Emerald Oaks*, DAB No. 1800 at 10; *CarePlex of Silver Spring*, DAB No. 1683 at 14-16 (1999); *Capitol Hill Cmty. Rehab. & Specialty Care Ctr.*, DAB No. 1629 (1997).

A CMP that is imposed against a facility on a per day basis falls into one of two ranges of penalties.  42 C.F.R. §§ 488.408, 488.438.  The upper range of a CMP, $6,808 per day to $22,320 per day, is reserved for deficiencies that pose immediate jeopardy to a facility’s residents and, in some circumstances, for repeated deficiencies.  42 C.F.R. § 488.438(a)(1)(i), (d)(2); 45 C.F.R. § 102.3 (Table) (2020).  The lower range of CMPs, $112 per day to $6,695 per day, is reserved for deficiencies that do not pose immediate jeopardy, but either cause actual harm to residents, or cause no actual harm but have the potential for causing more than minimal harm.  42 C.F.R. § 488.438(a)(1)(ii); 45 C.F.R. § 102.3 (Table) (2020).

Petitioner argues that the findings of noncompliance and immediate jeopardy are improper, so the CMP is unreasonable.  P. Prhg. Br. at 21; P. Br. at 13; P. Reply at 8.

Page 33

In determining the reasonableness of the proposed CMP, I am to consider the per day amount and number of days of noncompliance, not, as Petitioner argues, the total amount of the CMP.  *Century Care of Crystal Coast*, DAB No. 2076 at 26 (2007).  Further, my review of the reasonableness of the CMP is de novo and I apply the factors established by 42 C.F.R. §§ 488.438 and 488.404.  I do not review whether CMS properly considered the factors specified by the regulations.  I consider the regulatory factors as follows:

CMS presented Petitioner’s AEM Nursing Home Enforcement History, which includes surveys from October 1, 2004 through May 8, 2020.  CMS Ex. 14.  According to the history, Petitioner had two deficiency citations at the “G” level citation in September 2019 and March 2017, for noncompliance cited under Tags F684 and F322, respectively, with CMPs imposed.  CMS Ex. 14 at 1, 3.  Petitioner was also cited for immediate jeopardy in December 2016, for noncompliance cited under Tags F157, F226, F309, F323, and F490, and a CMP was imposed.  CMS Ex. 14 at 3.  In January 2016, Petitioner was cited for noncompliance under Tag F323 that posed immediate jeopardy and a CMP was imposed.  CMS Ex. 14 at 4.

Petitioner has presented no evidence showing it is financially unable to pay the CMP.

Petitioner’s noncompliance is very serious.  Resident 1 sustained several suspicious injuries and ultimately sustained multiple head lacerations, requiring treatment at the hospital.  Petitioner was culpable for its noncompliance, which involved the failure to follow care planned interventions which amounts to neglect and failure to prevent Resident 1 from being abused by Resident 2 and the failure to provide adequate supervision to prevent accidents.

Petitioner’s noncompliance posed immediate jeopardy to Resident 1 and other residents with similar monitoring and supervision needs.  The lack of adequate supervision represented a pattern of noncompliance that involved multiple staff members over multiple shifts and multiple days.  Resident 1 suffered actual serious harm in the form of suspicious injuries and multiple head lacerations requiring hospitalization to repair.  There was also immediate jeopardy for other residents due to the risk for probable serious harm or death due Petitioner’s failure to provide adequate supervision and failure to follow care planned interventions.

The CMP $14,100 per day from February 6 through 15, 2020, the period of immediate jeopardy is just above the middle of the upper range of CMPs authorized for noncompliance that poses immediate jeopardy.  The CMP of $150 per day from February 16 through March 10, 2020, is at the low end of the range of CMPs authorized for noncompliance that does not pose immediate jeopardy.  I conclude that a CMP of $14,100 per day for noncompliance that posed immediate jeopardy is reasonable based on my de novo review applying the required factors.  I also conclude that the CMP of

Page 34

$150 per day for the noncompliance that did not pose immediate jeopardy is reasonable based on my consideration of the required factors.  I do not make findings or conclusions regarding alleged noncompliance under other Tags cited by the surveyors as the continuing noncompliance under Tags F600 and F689 is a more than sufficient basis to impose the $150 per day CMP, and that CMP is reasonable based on that noncompliance alone.

III.    Conclusions

For the foregoing reasons, I conclude that:

Petitioner was not in substantial compliance with program participation requirements from February 6 through March 10, 2020, due to violations of 42 C.F.R. §§ 483.12 (Tag F600), and 483.25(d) (Tag F689), each of which posed a risk for more than minimal harm;

The determination of immediate jeopardy, including its duration, was not clearly erroneous; and

Reasonable enforcement remedies are a CMP of $14,100 per day from February 6 through 15, 2020, and a CMP of $150 per day from February 16, 2020 through March 10, 2020.

Endnotes

1  Citations are to the 2019 revision of the Code of Federal Regulations (C.F.R.), which was in effect at the time of the February 15, 2020 survey, unless otherwise indicated.  Appellate panels of the Board have concluded it is appropriate in long-term care facility survey cases to apply the revision of the regulatory participation requirements in the revision of the C.F.R. in effect at the time a survey was conducted.  *Good Shepard Home for the Aged, Inc.*, DAB No. 2858 at 1 n.1 (2018); *Carmel Convalescent Hosp.*, DAB No. 1584 at 2 n.2 (1996).  In this case, the events for which immediate jeopardy was alleged occurred in February 2020, the survey occurred on February 15, 2020, the CMS initial determination was issued on September 14, 2020, and the CMS revised notice of imposition of remedies was issued on January 29, 2021.

2  CMS’s notice letter cited Petitioner for failing to comply with five participation requirements cited as noncompliance under Tags F580, F600, F689, F865, and F921.  Tags F600 and F689 were cited at the “J” level of scope and severity (immediate jeopardy); Tags F580, F865, and F921 were cited at the “E” level of scope and severity (no harm but potential for more than minimal harm).  CMS Ex. 1 at 1.  I make no findings and conclusions regarding the noncompliance alleged under Tags F580, F865, and F921 that allegedly posed a risk for more than minimal harm without actual harm or immediate jeopardy.  Therefore, those citations of noncompliance are not upheld by this decision.  As explained in the section discussing the reasonableness of the CMP, the amount of the CMP in this case is not affected by the nonimmediate jeopardy citations of noncompliance because I would not exercise my discretion to decrease the minimal CMP in the lower range of CMPs proposed by CMS, even if I found there was no noncompliance under Tags F580, F865, and F921.

3  SNFs and NFs are often referred to as long-term care facilities or nursing homes.  NF participation in Medicaid is governed by section 1919 of the Act.  Section 1919(h)(2) of the Act gives enforcement authority to the states to ensure that NFs comply with their participation requirements established by sections 1919(b), (c), and (d) of the Act.

4  CMS annually adjusts CMP amounts that may be imposed to account for inflation in compliance with the Federal Civil Penalties Inflation Adjustment Improvements Act of 2015, Pub. L. No. 114-74, § 701, 129 Stat. 584, 599 (2015).  81 Fed. Reg. 61,538, 61,549 (Sept. 6, 2016).

5  Congress granted the Secretary authority to impose enforcement remedies for noncompliance.  Act § 1819(h)(2).  The Secretary is authorized to impose CMPs as an enforcement remedy by section 1128A of the Act.  CMPs are imposed by CMS with delegated authority of the Secretary.  42 C.F.R. § 488.2.  Pursuant to subsection 1128A(j) of the Act, section 205 of the Act is applicable to the imposition of CMPs, and that section is applicable to the imposition of CMPs by both the Secretary and the Commissioner of Social Security under the authority of section 1128A of the Act.  The Inspectors General (IGs) for both HHS and the Social Security Administration (SSA) also exercise delegated authority to impose CMPs pursuant to section 1128A of the Act.  Both IGs engaged in rulemaking to specify the allocation of the burden of persuasion and the quantum of evidence required when proceeding upon a case involving a CMP.  Both the SSA IG and the HHS IG imposed upon the government in CMP cases the burden of persuasion on all issues other than affirmative defenses and mitigating factors for which the burden is upon the nongovernmental party.  The regulations of the IGs for SSA and HHS provide that the burden of persuasion is to be judged by a preponderance of the evidence.  20 C.F.R. § 498.215(b), (c); 42 C.F.R. § 1005.15(b), (d).  CMS failed to promulgate a regulation like those of the HHS and SSA IGs and the Board has filled the gap with its interpretative rules allocating the burden of persuasion to the nongovernmental party, the party defending against the imposition of the CMP.

6  “Credible evidence” is evidence that is worthy of belief.  *Black**’**s Law Dictionary* 596 (8th ed. 2004).  The “weight of evidence” is the persuasiveness of some evidence compared to other evidence.  *Id*. at 1625.

7  This is a “Tag” designation as used in CMS Pub. 100-07, State Operations Manual (SOM), app. PP – Guidance to Surveyors for Long Term Care Facilities (https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107ap_pp_guidelines_ltcf.pdf).  The “Tag” refers to the specific regulatory participation requirement allegedly violated and CMS’s policy guidance to surveyors.  Although the SOM does not have the force and effect of law, the provisions of the Act and regulations interpreted clearly do have such force and effect.  *Ind. Dep’t. of Pub. Welfare v. Sullivan*, 934 F.2d 853 (7th Cir. 1991); *Nw. Tissue Ctr v. Shalala*, 1 F.3d 522 (7th Cir. 1993).  Thus, while the Secretary may not seek to enforce the provisions of the SOM, he may seek to enforce the provisions of the Act or regulations as interpreted by the SOM.

8  CMS and the state agency use scope and severity levels when selecting remedies.  The scope and severity level is designated by an alpha character, A through L, selected by CMS or the state agency from the scope and severity matrix published in the SOM, chap. 7, § 7400E.  A scope and severity level of A, B, or C indicates a deficiency that presents no actual harm but has the potential for minimal harm, which is an insufficient basis for imposing an enforcement remedy.  Facilities with deficiencies of a level no greater than C remain in substantial compliance.  42 C.F.R. § 488.301.  A scope and severity level of D, E, or F indicates a deficiency that presents no actual harm but has the potential for more than minimal harm that does not amount to immediate jeopardy.  A scope and severity level of G, H, or I indicates a deficiency that involves actual harm that does not amount to immediate jeopardy.  Scope and severity levels J, K, and L are deficiencies that constitute immediate jeopardy to resident health or safety.  The matrix, which is based on 42 C.F.R. § 488.408, specifies which remedies are required and optional at each level based upon the frequency of the deficiency.

9  Petitioner argues that surveyor notes show that during the survey that ended on February 15, 2020, a surveyor did not find any abuse or neglect or a problem with injuries of unknown origin due to lack of supervision to prevent accidents.  P. Reply at 3-4.  My review is de novo and I am not bound by the findings of the surveyors.  As explained in detail in this decision, I find and conclude that the preponderance of the evidence establishes noncompliance under both Tags F600 and F689 based on the example of Resident 1.

10  Decisions often cited include *Lakeport Skilled Nursing Ctr.*, DAB No. 2435 at 6 (2012); *Liberty Health & Rehab. of Indianola, LLC*, DAB No. 2434 at 13, 18-19 (2011); *Yakima Valley* Sch., DAB No. 2422 at 8; *Lutheran Home at Trinity Oaks*, DAB No. 2111 (2007); *Daughters of Miriam Ctr.*, DAB No. 2067; *Britthaven of Havelock*, DAB No. 2078 (2007); *Koester Pavilion*, DAB No. 1750; and *Woodstock Care Ctr.*, DAB No. 1726.

11  The Board’s characterization of the clearly erroneous standard as being highly deferential to the fact-finding by the state agency surveyor and CMS, and even triggering a rebuttable presumption, is entirely consistent with the Supreme Court’s characterization of the standard.  However, the Court’s cautions about ensuring meaningful review rather than rubber-stamping agency decisions shows it is important for the ALJ and the Board not to be tempted to simply defer to the surveyor, the state agency, or CMS on the immediate jeopardy issue.
  
          /s/
        Keith W. Sickendick

                      Administrative Law Judge Back to top
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