Skip to main content


U.S. flag
      An official website of the United States government
              Here’s how you know
        Here’s how you knowDot gov**Official websites use .gov**
                 A **.gov** website belongs to an official government organization in the United States.
                  HTTPS**Secure .gov websites use HTTPS**
                 A **lock** (A locked padlock) or **https://** means you’ve safely connected to the .gov website. Share sensitive information only on official, secure websites. 
  Menu Close
          HHS Search block
    Search
        








  
  
    

  
      

                                      About HHS
    
                        
                              
      
      
      Programs & Services
    
                        
                              
      
      
      Grants & Contracts
    
                        
                              
      
      
      Laws & Regulations Breadcrumb
    Home
                              About
                              Agencies
                              DAB
                              Decisions
                              ALJ Decisions
                              2023 ALJ Decisions
                              Hill Country Nursing and Rehab, DAB CR6258 (2023)
 Navigate to:
  Departmental Appeals Board (DAB)
    
                                                  
                                                    
            
      
      
      
      About DAB
                                            
            
            Organizational Overview
    
                                                  
                              
            
      
      
      
      Who are the Judges?
    
                                                  
                              
            
      
      
      
      DAB Divisions
    
                                                  
                              
            
      
      
      
      Contact DAB
    
                                                  
                                                    
            
      
      
      
      Filing an Appeal Online
                                            
            
            DAB E-File
    
                                                  
                              
            
      
      
      
      Medicare Operations Division (MOD) E-File
    
                                                  
                                                    
            
      
      
      
      Different Appeals at DAB
                                            
            
            Appeals to DAB Administrative Law Judges (ALJs)
                          
            
            Forms
    
                                                  
                              
            
      
      
      
      Procedures
    
                                                                
                                                    
            
      
      
      
      Appeals to Board
                          
            
            Practice Manual
    
                                                  
                              
            
      
      
      
      Guidelines
    
                                                  
                              
            
      
      
      
      Regulations
    
                                                  
                              
            
      
      
      
      National Coverage Determination Complaints
    
                                                                
                                                    
            
      
      
      
      Appeals to the Medicare Appeals Council (Council)
                          
            
            Forms
    
                                                  
                              
            
      
      
      
      Fully Integrated Duals Advantage (FIDA) Demonstration Project
    
                                                  
                                                    
            
      
      
      
      Alternative Dispute Resolution Services
                                            
            
            Sharing Neutrals
    
                                                  
                              
            
      
      
      
      ADR Training
    
                                                  
                              
            
      
      
      
      Other ADR Services
    
                                                  
                                                    
            
      
      
      
      DAB Decisions
                                            
            
            Board Decisions
    
                                                  
                              
            
      
      
      
      DAB Administrative Law Judge (ALJ) Decisions
    
                                                  
                              
            
      
      
      
      Medicare Appeals Council (Council) Decisions
    
                                    
                              
            
      
      
      
      Stakeholder Feedback
    
                                                  
                                                    
            
      
      
      
      Careers
                                            
            
            Open Career Opportunities
    
                                                  
                              
            
      
      
      
      Internships & ExternshipsText resize icon

                    




Hill Country Nursing and Rehab, DAB CR6258 (2023)








  
  
    

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





Hill Country Nursing and Rehab
(CCN: 675980),

v.

Centers for Medicare & Medicaid Services
Docket No. C-21-450Decision No. CR6258March 29, 2023

        
              
    

      DECISION

Petitioner, Hill Country Nursing and Rehab, is a long-term-care facility, located in Dripping Springs, Texas, that participates in the Medicare program.  This case involves two complaint investigation surveys of that facility.

In the first survey, completed September 30, 2020, a state surveyor investigated the death of a resident reported to be at risk of falling, who was found lying on the floor of his room.  Based on the survey findings, the Centers for Medicare & Medicaid Services (CMS) determined that the facility was not in substantial compliance with that portion of the quality-of-care regulation that addresses accident prevention, 42 C.F.R. § 483.25(d), and imposed a $22,320 per-instance civil money penalty (CMP).

During the second survey, completed October 14, 2020, state surveyors investigated the facility’s infection control practices.  Based on their findings, CMS determined that the facility was not in substantial compliance with the regulation governing infection control and prevention, 42 C.F.R. § 483.80(a), and imposed a $15,000 per-instance CMP.  CMS also determined that the facility was not in substantial compliance with the food safety

Page 2

regulation, 42 C.F.R. § 483.60(i), but it imposed no penalty for that deficiency, which is therefore not reviewable in this forum (see discussion below).

Petitioner appealed.

For the reasons set forth below, I find that the facility was not in substantial compliance with 42 C.F.R. §§ 483.25(d) and 483.80(a) and that the penalties imposed are reasonable.

Background

The Social Security Act (Act) sets forth requirements for nursing facilities to participate in the Medicare program and authorizes the Secretary of Health and Human Services to promulgate regulations implementing those statutory provisions.  Act § 1819.  The Secretary’s regulations are found at 42 C.F.R. Part 483.  To participate in the Medicare program, a nursing facility must maintain substantial compliance with program requirements.  To be in substantial compliance, a facility’s deficiencies may pose no greater risk to resident health and safety than “the potential for causing minimal harm.”  42 C.F.R. § 488.301.

The Secretary contracts with state survey agencies to conduct periodic surveys to determine whether skilled nursing facilities are in substantial compliance.  Act § 1864(a); 42 C.F.R. § 488.20.  Each facility must be surveyed annually, with no more than fifteen months elapsing between surveys.  Facilities must be surveyed more often, if necessary, to ensure that identified deficiencies are corrected.  Act § 1819(g)(2)(A); 42 C.F.R. §§ 488.20(a), 488.308.  The state agency must also investigate all complaints.  Act § 1819(g)(4).

**The surveys**.  This case involves two surveys, completed September 30, 2020, and October 14, 2020.

Responding to a complaint, a surveyor from the Texas Health and Human Services Commission (state agency) completed an incident investigation survey on September 30, 2020.  CMS Ex. 1; CMS Ex. 7 at 1.  Based on the survey findings, CMS determined that the facility was not in substantial compliance with **42 C.F.R. § 483.25(d) (Tag F689)** (quality of care – preventing accidents), cited at scope-and-severity level D (isolated instance of substantial noncompliance that causes no actual harm, with the potential for more than minimal harm).  CMS Exs. 1, 3.

On October 14, 2020, the state surveyors completed a second survey, investigating the facility’s infection-control practices.  Based on those survey findings, CMS determined that the facility was not in substantial compliance with:

Page 3

**42 C.F.R. § 483.80(a)(1)(2)(4)(e)(f) (Tag F880) (infection control – prevention and control program)**, cited at scope and severity level E (pattern of substantial noncompliance that causes no actual harm, with the potential for more than minimal harm); and42 C.F.R. § 483.60(i) (Tag F812) (food safety), cited at scope and severity level F (widespread substantial noncompliance that causes no actual harm, with the potential for more than minimal harm).CMS Exs. 3, 8.

Thereafter, CMS determined that the facility returned to substantial compliance on November 11, 2020.  CMS Ex. 2.

Based on the deficiencies cited, CMS has imposed against the facility per instance penalties of $22,320 for the quality-of-care deficiency cited during the September 30 survey and $15,000 for the infection control deficiency cited during the October 14 survey.  It imposed no penalty for the food safety deficiency.  CMS Ex. 2 at 1.

Petitioner appealed.

Because CMS imposed no penalty for the food-safety deficiency, it is not reviewable.  A facility may challenge a finding of noncompliance for which CMS imposes one of the penalties specified in 42 C.F.R. § 488.406.  42 C.F.R. § 498.3(b)(13); *see* 42 C.F.R. § 498.3(a).  A facility has no right to a hearing unless CMS imposes one of the specified remedies.  The *remedy*, not the citation of a deficiency, triggers the right to a hearing.  *Lutheran Home – Caledonia*, DAB No. 1753 (2000).

CMS submitted a motion for summary judgment and brief in support (CMS Br.).  Petitioner filed a prehearing brief (P. Br.).  The parties also filed closing briefs (CMS Cl. Br.; P. Cl. Br.).

**Motion for summary judgment/hearing on the written record**.  I found that material facts are in dispute and denied CMS’s motion for summary judgment.  Order Summarizing Pre-Hearing Conference at 2 (Oct. 4, 2022).

Nevertheless, this case may be decided based on the written record.  In my standing order, I explained that a hearing to cross-examine witnesses would be necessary only if a party files admissible, written direct testimony, and the opposing party asks to cross-examine.  Standing Order at 5.  CMS lists two witnesses and provides their written direct testimony.  Petitioner lists five witnesses and provides their written direct testimony.  Initially, each side asked to cross-examine all of the opposing witnesses.  Order Summarizing Pre-Hearing Conference at 3-4.  The parties subsequently withdrew their

Page 4

requests to cross-examine.  An in-person hearing would therefore serve no purpose, and the case may be decided based on the written record.  Order Setting Closing Brief Schedule at 1 (Oct. 7, 2022).1

**Exhibits**.  CMS submitted 15 proposed exhibits (CMS Exs. 1-15), and Petitioner submitted 34 proposed exhibits (P. Exs. 1-34).

After reviewing the parties’ closing submissions, I determined that relevant and material evidence was available but had not been submitted, which I obtained and marked as ALJ exhibits.  The documents are:

CMS’s COVID-19 nursing home data as of January 15, 2023 (ALJ Ex. 1);
	the state agency’s data listing Texas nursing facilities’ COVID-19 status, which is current as of September 30, 2020 (ALJ Ex. 2); and
	excerpts from a nursing home site reflecting the facility’s (Hill Country’s) COVID data.  ALJ Ex. 3.In an order dated February 1, 2023, I offered the parties the opportunity to respond to these new, proposed exhibits, noting that, pursuant to 42 C.F.R. § 498.60(b)(2), if I believe that there is relevant and material evidence available that has not been presented, I may, at any time before mailing the notice of decision, reopen the hearing to receive the evidence.

**Petitioner’s objections:  CMS Exhibits**.  Petitioner objected to many of CMS’s exhibits or sections of them (CMS Exs. 1, 6-8, 10-12, and 15), including the statements of deficiencies (CMS Exs. 1 and 8).  Based on the rules governing the admission of evidence in these proceedings, I found that Petitioner’s objections lack merit.

I have broad discretion to admit evidence.  The Federal Rules of Evidence do not apply, and I may receive evidence, including hearsay, that would be inadmissible under the federal rules.  42 C.F.R. § 498.61; *Lifehouse of Riverside Healthcare Ctr.*, DAB No. 2774 at 9 (2017).  I may admit hearsay “consistent with procedural integrity and fundamental fairness.”  *Omni Manor Nursing Home*, DAB No. 1920 (2004).

Page 5

Moreover, I am *required* to “inquire[] fully into all of the matters at issue” and *to admit any documents that are relevant and material*.  42 C.F.R. § 498.60(b).  This necessarily includes the statements of deficiencies.  A statement of deficiencies sets out the survey findings on which CMS bases its enforcement actions that are the subject of appeal and, for that reason, is “unquestionably relevant and material evidence.”  *Avalon Place Trinity*, DAB No. 2819 at 38 (2017); *see Oxford Manor*, DAB No. 2167 at 2 (2008) (holding that a statement of deficiencies may function both as a notice document and as evidence of facts asserted therein); *Jennifer Matthew Nursing & Rehab. Ctr.*, DAB No. 2192 at 4 n.2 (2008) (holding that CMS need not present evidence in support of a finding in a SOD that is not disputed); *Guardian Health Care Ctr.*, DAB No. 1943 at 12 (2004) (characterizing the statement of deficiencies as a “contemporaneous record of the survey agency’s observations and investigative findings.”).  As such, the statement of deficiencies is relevant and material and must be admitted.

I also overruled Petitioner’s objections to CMS Ex. 15, the written declaration of CMS nurse consultant Daniel J. McElroy, R.N., finding it not wholly irrelevant or immaterial (particularly in light of some of Petitioner’s complaints, which I discuss below).

Petitioner also objected to CMS Exs. 7 and 10, which are surveyor investigation notes.  Petitioner argued that the notes are irrelevant because they include findings not specifically cited in the statements of deficiencies.  CMS, however, is not limited to the specific allegations included in a statement of deficiencies.  As the Departmental Appeals Board has repeatedly explained, the statement of deficiencies is a notice document, not intended to “lay out every single detail in support of finding that a violation has been committed.”  *Alden Town Manor Rehab. & HCC*, DAB No. 2054 at 17 (2006) (citing*Pac. Regency Arvin*, DAB No. 1823 at 9-10 (2002)).  So long as the facility knows what it must answer to – which, as here, was accomplished through record development – the facility has sufficient notice.

I admitted into evidence CMS Exs. 1-15.  Order Summarizing Pre-Hearing Conference at 3.

**Petitioner’s objections:  ALJ exhibits**.  Petitioner concedes, as it must, that an ALJ may receive relevant evidence after the record closes.  P. Response to ALJ’s Proposed Exhibits at 1 (Mar. 3, 2023); *see* 42 C.F.R. § 498.60(b)(2).  Petitioner argues, however, that “neither section 498.60(b)(2) nor any other federal regulation or statute applicable to this case authorizes the ALJ to inject evidence that has not been offered by either party.”  P. Response at 1.

Petitioner also characterizes my admitting these exhibits as “an attempt to undermine the credibility of Petitioner’s witnesses, whose testimony and documentary evidence . . . were admittedly unchallenged by CMS.”  According to Petitioner, my admitting these

Page 6

publicly available documents “impermissibly injects the ALJ into the proceedings as CMS’[s] advocate in making a legal argument CMS chose not to make.”  P. Response at 1-2.

Petitioner cites no authority for any of these assertions and they lack merit.

First, as discussed above, the regulations give me broad authority to admit evidence and direct me to “inquire[ ] fully into all of the matters at issue.”  42 C.F.R. § 498.60.  To comply with this regulatory mandate, many ALJs have admitted exhibits not proffered by either party, and the Board has not questioned the practice.  *Quality Total Care, L.L.C.*, DAB No. 2242 at 3 n.3 (2009); *Harlan Nursing Home*, DAB No. 2174 at 11 n.9 (2008); *Tri-County Extended Care Ctr.*, DAB No. 2060 at 2 (2007); *see Rudra Sabaratnam and Robert I Bourseau*, DAB No. 2139 at 5 n.6 (2007) (involving an exclusion brought by the Inspector General).

In *Social Security Administration v. National Fed’n. of Retired Persons*, the Board directly addressed the practice and approved of it.  DAB No. 1885 (2003).  There, a party alleged bias because, following the hearing, but before issuing a decision, the ALJ sought to confirm a witness’s testimony by reading publicly available documents from an official government website.  The Board confirmed that “[i]t is entirely appropriate for a judge to take notice of publicly available facts[,]” citing Fed. R. Evid. 201(b), which states “A judicially noticed fact must be one not subject to reasonable dispute in that it is either 1) generally known within the territorial jurisdiction of the trial court or 2) capable of accurate and ready determination by resort to sources whose accuracy cannot reasonably be questioned.”  *SSA v NFRP*, DAB No. 1885 at 39 (2003) (citing *Austin v. American Ass’n. of Neurological Surgeons*, 253 F.3d 967, 971 (7th Cir. 2001) (taking judicial notice of reliable information published on the internet)).

In the recent case of *New Grove Manor*, a facility cited the COVID pandemic as good cause for its failing to request timely an ALJ hearing.  But its assertions regarding the alleged outbreak were vague, and the facility proffered no evidence in support.  In order to assess the facility’s “good cause” theory, the ALJ “exercised discretion in taking notice of publicly-available data that [the facility] itself had reported to CMS.”  Her findings undercut the facility’s reliance on COVID-19 developments to bolster its arguments, and the ALJ dismissed the appeal as untimely filed.  The Board affirmed the dismissal and found no fault with the ALJ, on her own, finding and reviewing the data.  *New Grove Manor*, DAB No. 3090 at 11-13 (2023).

With respect to Petitioner’s complaint that my reviewing the data undermines the credibility of its witnesses, I note that the data itself is inherently factual and neutral.  If this evidence undermines Petitioner’s witnesses and strengthens CMS’s case (which I discuss below), it does so only because it contradicts claims made by Petitioner and its witnesses.  Had those claims been accurate, the evidence would have supported them.

Page 7

Finally, I do not agree that, by admitting this evidence, I am “making a legal argument CMS chose not to make.”  Rather, admitting this evidence supports the legal argument upon which CMS bases its case.  Although CMS agrees that the data “undermines [Petitioner’s] unequivocal representations,” it argues that the data is secondary to “the crux of Petitioner’s substantial noncompliance,” which is “grounded in Petitioner’s failure to follow its infection control policies and procedures, regardless of the COVID-19 status of its isolation hall population.”  CMS Response to ALJ’s Order at 2 (Mar. 3, 2023).  Petitioner, however, does not dispute that facilities must follow their policies.  Instead, it argues that those policies did not apply here because, contrary to what staff told the surveyor, the isolation hall was not really an isolation hall, and no resident required isolation.  The new evidence strengthens CMS’s position that the facility needed – and had – an isolation hall.

I admit into evidence ALJ Exs. 1-3.

**Petitioner’s exhibits**.  In the absence of any objections, I admitted into evidence P. Exs. 1-34).  Order Summarizing Pre-hearing Conference at 3.

Issues

The issues are:

Was the facility in substantial compliance with 42 C.F.R. § 483.25(d);
	Was the facility in substantial compliance with 42 C.F.R. § 483.80(a); and
	If the facility was not in substantial compliance, are the penalties imposed – $22,320 and $15,000 per-instance – reasonable?  ****Discussion

**The September 30, 2020 Survey.**

**Petitioner’s complaints about surveyor performance and CMS’s evidence**.  As a threshold matter, Petitioner accuses CMS and the surveyors of “glaring omissions” because (in Petitioner’s view) CMS did not produce sufficient medical records to support its claim that the facility failed to take adequate precautions to prevent a vulnerable resident from falling.  Petitioner maintains that the state surveyor could have obtained these documents during the survey and characterizes their absence as “fatal to CMS’[s] case.”  In fact, Petitioner suggests that CMS deliberately omitted the records because they do not support a finding of substantial noncompliance with section 483.25(d).  According to Petitioner, the evidence CMS produced – the statement of deficiencies, surveyor notes,

Page 8

some medical records, and surveyor testimony – is insufficient to establish substantial noncompliance.  P. Cl. Br. at 2-4.

In making this argument, Petitioner disregards the parties’ relative burdens here.

More than twenty-five years ago, the Board issued its seminal decision in *Hillman*, which explains how, pursuant to the Medicare statute, the burdens of proof are allotted in provider appeals (there, a rehabilitation agency):  CMS must come forward with evidence sufficient to establish a prima facie case that it had a legally sufficient basis for imposing remedies.  The petitioner then has the ultimate burden of persuasion.  To prevail, it must prove, by a preponderance of the evidence, that it is in substantial compliance with the relevant statutory and regulatory provisions.  *Hillman Rehab. Ctr.*, DAB No. 1611 at 8 (1997), *aff’d Hillman Rehab. Ctr. v. U.S. Dep’t of Health and Human Servs.*, No. 98-3789 (GEB) 1999 WL 34813783 (D.N.J. May 13, 1999).

Later, in *Batavia*, the Board summarized *Hillman’s* rationale and applied it to nursing home appeals:

Congress authorized Medicare payments to facilities only if they meet the applicable conditions of participation.  “A mere determination on appeal that it is only ‘as likely’ that the conditions were substantially met as that they were not met could result in payment contrary to statutory intent.”  The purpose of the conditions – to protect the health and safety of facility residents – requires an affirmative determination of substantial compliance.
	In deciding who has the burden of proof, it is traditional (and based on fundamental fairness) to consider who has knowledge of the facts involved, which would be the facility.
	Allocating the burden of proof to the facility does not violate the Administrative Procedures Act (which provides that the proponent of a rule or order bears the burden of proof) because the *facility* is the proponent of an order finding it in substantial compliance with Medicare participation requirements.*Batavia Nursing & Convalescent Ctr.*, DAB No. 1904 (2004), *aff’d.*129 F. App’x 181 (6th Cir. 2005); *Emerald Oaks*, DAB No. 1800 (2001).

CMS meets its burden if the evidence it relies on is sufficient to support a decision in its favor, absent an effective rebuttal.  *Evergreene Nursing Care Ctr*., DAB No. 2069 at 7 (2007) (citing *Hillman*, DAB No. 1611 (1997) and *Batavia*, DAB No. 1911 (2004)).  If unrebutted, a statement of deficiencies, by itself, may be sufficient to establish CMS’s prima facie case.  *Universal Health Care – King*, DAB No. 2383 at 9 (2011).  Here, as the following discussion shows, CMS proffered evidence sufficient to establish that the

Page 9

facility was not in substantial compliance.  Although Petitioner responds with additional evidence, including its own limited number of medical records, those documents do not rebut CMS’s case, and, in fact, they support CMS’s finding of substantial noncompliance.

Petitioner also faults the surveyor for making three visits to the facility, over the course of a month, before finally citing a deficiency.  P. Br. at 10; P. Cl. Br. at 10.  For skilled nursing facilities, *CMS*, not the individual surveyor nor even the state agency, ultimately decides whether a deficiency should be cited.  42 C.F.R. § 488.452(a)(2); *see* CMS Ex. 15 at 2 (McElroy Decl. ¶¶ 2, 3).  Here, the backlog of enforcement actions caused by the COVID-19 pandemic delayed CMS’s review of the survey findings.  CMS Ex. 15 at 2, 4 (McElroy Decl. ¶ 4).  Moreover, even if the surveyor erred (and I see no evidence of it), inadequate survey performance does not invalidate adequately documented deficiencies.  42 C.F.R. § 488.318(b); *see Avon Nursing Home*, DAB No. 2830 at 11-15 (2017) and cases cited therein (noting that “the Board has consistently held that allegations of inadequate survey performance are irrelevant to ALJ or Board review of CMS’s noncompliance and remedy determinations.”).

Finally, Petitioner incorrectly asserts that “the only claim relevant” to the quality-of-care deficiency is whether the facility failed to provide one of its residents with a fall mat, as ordered by his nurse practitioner.  P. Br. at 2; P. Cl. Br. at 4.  CMS’s case is not so limited.  As discussed below, the evidence establishes other ways in which the facility did not take reasonable steps to mitigate foreseeable risks of harm from accidents, including the facility’s inaccurately assessing a resident’s risk for falls and its inadequate care planning to address that risk.

***The facility was not in substantial compliance with section 483.25(d) because it did not take reasonable steps to ensure that a vulnerable resident received the supervision and assistance devices required to mitigate foreseeable risks of harm from accidents.  It failed to assess adequately his risks; it failed to develop a care plan to address those risks; and it failed to provide him with basic assistance devices to mitigate the risks of harm from accidents.2*****Program requirements: 42 C.F.R. § 483.25(d) (Tag F689)**.  The Medicare statute requires that the facility ensure that each resident receive, and the facility provide, the necessary care and services to allow the resident to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the resident’s comprehensive assessment and plan of care.  Act § 1819(b)(2).  To this end, the “quality of care” regulation mandates, among other requirements, that the facility

Page 10

“ensure” that each resident’s environment remain as free of accident hazards as possible and that each resident receive adequate supervision and assistance devices to prevent accidents.  42 C.F.R. § 483.25(d); *Heritage Plaza Nursing Ctr.*, DAB No. 2829 at 6 (2017).  The facility must therefore eliminate or reduce a known or foreseeable risk of accidents “to the greatest degree practicable.”  *Del Rosa Villa*, DAB No. 2458 at 7 (2012); *Clermont Nursing & Convalescent Ctr.*, DAB No. 1923 at 9-10 (2004), *aff’d*142 F. App’x 900 (6th Cir. 2005); *accord* *Briarwood* *Nursing Ctr.*, DAB No. 2115 at 5 (2007) (holding that the facility must “take all reasonable steps to ensure that a resident receives supervision and assistance devices that meet his or her assessed needs and mitigate foreseeable risks of harm from accidents.”).  A facility is permitted the flexibility to choose the methods it uses to prevent accidents, but the chosen methods must constitute an “adequate” level of supervision under all the circumstances.  42 C.F.R. § 483.25(d); *Briarwood*, DAB No. 2115 at 5; *Windsor Health Care Ctr.*, DAB No. 1902 at 5 (2003), *aff’d* 127 F. App’x 843 (6th Cir. 2005).

**Facility policy:  fall precaution protocol**.  As the Board has repeatedly explained, a facility’s policy for implementing a regulatory requirement reflects the facility’s own judgment about how best to achieve substantial compliance.  Failing to comply with its own policies “can support a finding that the facility did not achieve compliance with the regulatory standard.”  *Bivins Memorial Nursing Home*, DAB No. 2771 at 9 (2017); *see Rockcastle Health and Rehab. Ctr.*, DAB No. 2891 at 19 (2018) (ruling that, absent contrary evidence, it is reasonable to presume that the facility’s policies reflect professional standards); *Hanover Hill Health Care Ctr.*, DAB No. 2507 at 6 (2013); *Life Care Ctr. of Bardstown*, DAB No. 2233 at 21-22 (2009) (finding that a facility’s failing to comply with its own policies can constitute a deficiency).

The facility had in place a policy addressing fall precautions.  P. Ex. 11.  The policy requires staff to complete a fall risk assessment for each resident at the time of admission, readmission, quarterly, and whenever the resident experiences significant changes.  Among other requirements, the resident must be screened for the use of side rails, low bed, or personal alarm.  Nursing and/or “Therapy” must *screen the resident for assistive devices*; and therapy must screen for decreased muscle strength.  Labs and medications must be reviewed “for potentiating factors.”  The resident must also be assessed for any change in condition, and staff should be alerted about the resident’s increasing needs.  P. Ex. 11 at 1.

A separate policy addresses the fall risk assessment, itself.  The policy’s stated purpose is to assess the resident’s risk factors related to falls and to implement appropriate interventions for preventing injuries.  Again, the policy requires staff to complete a fall risk assessment for each resident at the time of admission, readmission, quarterly, and whenever the resident experiences a significant change in condition.  The assessment form is kept in the resident’s clinical record (Assessments Section) and is discussed at each care plan meeting.  The facility’s *documentation must reflect “all attempts made by*

Page 11

*the facility to assess and reduce” the resident’s risk of falling*.  If the resident scores 10 or greater on the assessment, the resident should be considered high risk for potential falls.  A prevention protocol is initiated immediately and documented on the care plan.  P. Ex. 11 at 2 (emphasis added).

The facility’s policies require a post-fall assessment to determine possible contributing factors to an incident resulting in a resident’s fall.  Staff are required to:  review the incident report for information related to the fall; review statements from any witnesses or, if the fall is unwitnessed, review an “Administrative Inquiry” for clues to the cause of the fall; complete a post-fall assessment form, in full; attach the post-fall assessment to the incident report “for complete investigation of [the] incident”; and institute any fall precaution protocols indicated.  P. Ex. 11 at 3; *see* P. Ex. 11 at 4 (post-fall assessment form).

**Resident 1 (R1)**.  R1 was a 70-year-old man, admitted to the facility on June 3, 2020, and readmitted, following a hospital stay, on July 16, 2020.  He suffered a memory deficit as the result of a cerebral infarction (stroke).  He also had peripheral vascular disease, kidney disease, type 2 diabetes, and other disorders.  In August 2020, he was diagnosed with congestive heart failure and enterocolitis (inflammation of the digestive track) due to clostridium difficile (a bacterial infection).  CMS Ex. 6 at 14-15; P. Ex. 16.

R1’s Minimum Data Set indicates that he had a moderate cognitive impairment.  CMS Ex. 1 at 2.

R1 had a history of falling.  CMS Ex. 6 at 15; P. Ex. 3 at 4, 8; P. Ex. 16 at 2; *see* P. Ex. 6 at 7; P. Ex. 7 at 2.

The record includes three fall risk assessments for R1:

The first, a fall assessment dated June 3, 2020, identifies R1 as a high risk for falls, scoring 12 on his assessment, due to his confused mental status, ambulation status (chair bound, requiring restraints and assistance with elimination), medications, and predisposing diseases.  P. Ex. 10 at 3.3Page 12

Petitioner cites two subsequent fall assessments to claim that, as of mid-July, R1 was no longer a fall risk.  P. Cl. Br. at 6.  The problem with this argument is that these assessments are demonstrably inaccurate.

A fall assessment, dated July 16, 2020, lowers R1’s fall risk score to 6.  According to the assessment, R1 was no longer confused but was alert and oriented; *his gait and balance were normal*; and he *no longer took medications that would affect his risk*.  P. Ex. 10 at 2.  This assessment is inconsistent with R1’s medical records.  No evidence suggests that his gait and balance were normal at that time nor that his medications had been changed in a way that decreased his risk of falls.4  To the contrary, as discussed in more detail below, he was hospitalized on June 30 and returned to the facility on July 15 with multiple new and very serious diagnoses, including unstable bradycardia (slow heart rate, which can cause dizziness, lightheadedness, and fainting).  P. Ex. 13.  Between mid-June and mid-July, the resident’s condition had been deteriorating, not improving.
	R1’s August 21, 2020 fall assessment score was 7.  The assessment again describes him as alert, but, unlike the July assessment, this assessment indicates that his medications added to his risk of falls.  P. Ex. 10 at 1.  Notably, the assessment inaccurately claims that R1 had experienced no falls within the prior three months.  In fact, R1 fell on July 17, 2020.  In an undated statement, signed by the facility’s director of nursing (DON) and an employee identified as LVN (licensed vocational nurse) A, the LVN reports that R1 fell on July 17, 2020.  P. Ex. 8 at 1.  Petitioner concedes that the resident fell on July 17, 2020.  P. Cl. Br. at 5 (“[H]is last fall was more than 2 months prior to the 9/30/20 survey[,] on 7/17/20.”).5Moreover, the August 21 fall assessment omits other significant information.  It does not mention a physician’s order for physical therapy, also entered on August

Page 13

21, 2020.  The therapy order calls for “gait training, [wheel chair] mobility to address *weakness, impaired coordination, gait abnormality*.”  The therapy was to continue until September 19.  P. Ex. 3 at 17 (emphasis added).

Nor does the assessment consider the resident’s osteomyelitis (bone infection), leg surgery, and cast.  R1’s physician, Dr. Jim Chudleigh, reports that the resident developed osteomyelitis in his left foot, for which he had surgery.  His leg was in a cast, and his mobility decreased as a result.  P. Ex. 13 at 1.  An entry in R1’s order sheet indicates that Nurse Practitioner Sherrel Downes ordered a protective boot for R1’s left lower extremity, starting August 21, 2020.  P. Ex. 3 at 17.

**Heparin prescriptions and fall precautions – August 21, 2020**.  On August 21, 2020, Nurse Practitioner Downes ordered the anticoagulant medication, Heparin.  At the same time, she issued a fall precaution order:  “If resident falls, he is to be sent to hospital immediately due to high dose anticoagulation therapy with [H]eparin.”  CMS Ex. 1 at 2-3; P. Ex. 3 at 1-2; P. Ex. 12.  The nurse practitioner also ordered that a fall mat be placed on each side of the resident’s bed every shift.  CMS Ex. 1 at 3; P. Ex. 3 at 7; P. Ex. 5 at 2.  His bed was to be in the lowest position whenever he was in bed, and the nurses were to monitor every shift.  P. Ex. 3 at 11.

An August 21, 2020 nurse’s note confirms, “**Due to resident anticoagulation therapy with heparin[,] fall precautions must be instituted.  Fall mats to be present on both sides of the bed at all times, bed in lowest position[,] and[,] if the resident is to fall[,] he must be sent to the [emergency room] for [evaluation] and [treatment].**”  CMS Ex. 1 at 3; P. Ex. 2 (emphasis in original).

A nurse’s note indicates that R1 was administered Heparin on August 28, but, on August 29, Nurse Practitioner Downes discontinued the medication so that his prothrombin time could be tested.  P. Ex. 3 at 1, 3; P. Ex. 6 at 11.  This was not a permanent change but was ordered in anticipation of a scheduled cardiology appointment.  *See* P. Ex. 6 at 6 (indicating Heparin change “until cardi[ology] appointment”).

**R1’s September 2 hospitalization and return to the facility**.  By September 1, R1 was taking Heparin once again.  However, his medical records indicate that on September 1, he began experiencing nausea and was vomiting a thick, dark red/maroon fluid.  On September 2, staff held his 6:00 a.m. Heparin dose and reported his new symptoms to Nurse Practitioner Downes, who directed them to send him to the hospital for further assessment because he was taking Heparin.  P. Ex. 6 at 2, 10; P. Ex. 9 at 3.  He was admitted to the hospital on September 2, and the Heparin was discontinued.  P. Ex. 6 at 7; P. Ex. 6 at 9, 10.

It appears that the facility’s practice was to discontinue, automatically, *all* orders whenever a resident was hospitalized, no matter how short the hospital stay.  *See*

Page 14

*generally* P. Ex. 3.  Petitioner has not explained how this practice was supposed to work in situations like R1’s, when the resident soon returns to the facility.  In any event, *all* of R1’s orders were cancelled, including his diet (P. Ex. 3 at 8), his “do not resuscitate” (DNR) instructions (P. Ex. 3 at 10), and even the certification that he required skilled care (P. Ex. 3 at 12).  The record is even more confusing because, again for reasons that Petitioner has not explained, the orders were not cancelled on the day R1 left the facility; they were cancelled on September 4 – the day he returned.  P. Exs. 3, 7.6

Along with all his other orders, R1’s order for fall mats was discontinued because he went to the hospital, not because anyone thought he was no longer at risk of serious injury from falls.  P. Ex. 3 at 7; P. Ex. 5 at 1; P. Ex. 7 at 1; *see* CMS Ex. 1 at 3 (reporting Nurse Practitioner Downes’ statement that R1 continued to be on fall precautions).

On September 4, 2020, R1 returned to the facility.  P. Ex. 6 at 7.  There is no evidence that nursing or therapy then screened him for assistance devices, as called for in the facility’s policy.  P. Ex. 11 at 1.  At the time of his readmission, R1’s revised care plan did not mention his fall risk, need for floor mats, or any other fall precaution.  CMS Ex. 1 at 2.  Entries identify problems with self-care and, in an incomplete entry, indicate that he requires assistance to turn and reposition in bed, and a mechanical lift for transfers.  P. Ex. 1 at 1.  Another entry identifies as a problem his limited physical mobility related to his stroke and other disease processes.  P. Ex. 1 at 3.

Petitioner, however, maintains that the facility did not have to address R1’s fall risk in his care plan nor reinstate any fall precautions, including floor mats, because, as of August 29, R1 was no longer taking Heparin and was therefore no longer a fall risk.  In making this argument, Petitioner tacitly acknowledges a link between Heparin and the need for fall precautions, including floor mats.  P. Br. at 6-8; P. Cl. Br. at 6.7

Page 15

Petitioner’s argument fails because, on September 4, Nurse Practitioner Downes *again ordered Heparin* and other medications.  CMS Ex. 1 at 3; P. Ex. 3 at 5, 20; P. Ex. 7 at 2, 3.8  The parties dispute whether she also renewed the order for fall mats.  In a September 17 interview, Nurse Practitioner Downes told Surveyor Burnham that she thought that R1 was on fall precautions because of the Heparin, and she thought the facility was using floor mats.  She speculated that the mats might not yet have been in place because R1’s room was changed when he returned from the hospital.  CMS Ex. 1 at 3.  She did not deny (and has not since denied) that R1 was a fall risk.  That she made the statement is unrefuted.  *See* *Beatrice State Developmental Ctr.*, DAB No. 2311 at 17, 18 (2010) (pointing out that the facility could have but did not present employee testimony that refuted the statements the surveyors claimed they made);*Omni Manor Nursing Home*, DAB No. 1920 at 11 (2004) (holding that the statements facility employees made to the surveyors may be admitted in an administrative proceeding and may constitute substantial evidence).

With or without a separate order, the evidence supports the proposition that, as long as R1 remained on Heparin therapy, fall precautions – including fall mats – should have been in place to protect him from serious injury.  I reject Petitioner’s suggestion that installing fall mats required an explicit order.  *See, e.g.*, P. Cl. Br. at 7.  The facility could have installed them with or without a separate order; they could and should have been part of the resident’s care plan.  Moreover, even if the facility required a specific order, staff should have asked the nurse practitioner (or physician) for one in order to satisfy the regulatory requirement that the facility take *every reasonable precaution* to eliminate foreseeable risks of harm from accidents.  42 C.F.R. § 483.25(d); *Briarwood*, DAB No. 2115 at 5.

To support its claim that, after he returned from the hospital on July 15, R1 was no longer a fall risk, Petitioner also points to one line from Dr. Chudleigh’s July 6, 2021 letter.  Petitioner does not submit a written declaration from Dr. Chudleigh, and his letter is not sworn to under oath.  In any event, the letter does not support Petitioner’s claim.  Dr. Chudleigh chronicles the resident’s increasing medical complications – infectious endocarditis; mitral valve vegetation; uncontrolled atrial fibrillation with unstable rapid ventricular response, requiring surgical intervention; severe C. Diff diarrhea; heart block and unsteady bradycardia, requiring a pacemaker.9  He then writes, “After he returned to

Page 16

our care at the Hill Country facility on 7/15/20, with the help of the therapy staff[,] he began to become stronger and re-conditioned.  He began making slow[,] steady progress.”  P. Ex. 13 at 1.

Dr. Chudleigh does not explain what he means by “began making slow[,] steady progress.”  R1’s medical records do not suggest significant improvement.  Even more telling, *Dr. Chudleigh does not deny that R1 was a fall risk*.

While arguing that the facility did not need to institute any fall precautions, Petitioner also claims that it “implemented a multitude of fall precautions.”  P. Br. at 9.  There are serious problems with this assertion.

Petitioner claims that the facility implemented monthly fall risk assessments.  In fact, nothing in the record suggests that the facility instituted monthly assessments in order to prevent falls.  The record contains three assessments, approximately one month apart.  However, each was required for a specific reason:  June 3, the time of R1’s admission; July 16, following his readmission; and August 21, when Nurse Practitioner Downes ordered Heparin and fall mats.  *See* P. Ex. 11 at 2 (requiring fall assessments at the times of admission, readmission, and significant change in condition).  Nor is there any evidence that these assessments led to interventions aimed at keeping the resident safe.  In fact, as discussed above, two out of the three assessments were inaccurate and used to justify the facility’s *failing* to care plan the resident for preventing falls.  The assessments were more likely to jeopardize his safety than to improve it.
	Petitioner claims that R1 was given “a specialized ‘scoop/bolster mattress’ or ‘sink bed’ that does not allow easy exit from the bed.”  P. Cl. Br. at 9.  This claim is based on a statement that a physical therapy technician made to the surveyor.  CMS Ex. 1 at 4.  The claim is repeated in the declarations of Steve Robinson, a facility owner and current administrator, and Christie Preston, the current Director of Nursing.  Neither was present in the facility during the time R1 resided there, and, thus, they are not in a position to know what kind of mattress the resident had.  P. Ex. 24 at 3 (Robinson Decl.); P. Ex. 25 at 1 (Preston Decl.); *see W. Tex.*, DAB No. 2652 at 14 (2015) (characterizing the testimony of a DON, who was not present in the facility, as “unsupported speculation” that does not raise or even create a “metaphysical doubt.”).10Page 17

DON Preston’s testimony is also inconsistent with another, handwritten but undated, statement she made.  In that statement, she does not claim that R1 had a scoop mattress bed; she says that he had a “low air loss mattress” that was in the lowest position.  P. Ex. 33 at 5.  R1’s medical record confirms that a *low air loss mattress* was ordered for him.  P. Ex. 3 at 5, 12; P. Ex. 7 at 3.  A low air loss mattress is designed to prevent and treat pressure sores; it is not used as a fall precaution.  *See* Medicare Coverage Database Search available at https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleld=52490 (last visited Mar. 24, 2023).

Petitioner claims that the resident was monitored at least every two hours “per facility protocol.”  Petitioner does not identify the “protocol” that required this monitoring.  Its fall policies do not.  P. Ex. 11.  Moreover, except for DON Preston’s handwritten, undated statement, which I consider “unsupported speculation,” I find no support for this claim.  *See W. Tex.*, DAB No. 2652 at 14.  R1’s orders require that he be checked *every shift* (for reasons other than his fall risk), not every two hours.  P. Ex. 3 at 5, 11, 14.  Petitioner has produced no records suggesting that he was monitored more frequently than that.**R1’s fall**.  As noted, R1 returned to the facility on September 4.  According to a nurse’s note, LVN A completed R1’s admission procedures sometime after 5:11 a.m. on the morning of September 5.  The LVN writes that he adjusted the resident to a comfortable position in bed, described as a “semi-fowler’s position.”  Semi-fowler’s position is a semi-seated position, with the resident’s head elevated 30 to 45 degrees.  P. Ex. 6 at 8; P. Ex. 9 at 1.

At about 6:00 a.m., a nurse aide found R1 lying face-down on the floor.  He was dead.  Using a Hoyer lift, staff returned him to bed.  They called Emergency Medical Services and the Justice of the Peace.  P. Ex. 6 at 8; P. Ex. 9 at 1.  Staff reported no blood on the floor, although, in written statements dated September 5, 2020, they reported seeing blood on the resident’s lip.  CMS Ex. 6 at 16, 17.  The nurse aide who found him later told Surveyor Burnham that R1 “was always trying to get [out of bed].”  Staff had answered his call light “a few times,” and the resident seemed agitated.  CMS Ex. 7 at 5.

We cannot know with any certainty the circumstances surrounding R1’s death because his fall was not witnessed, and the record includes minimal evidence of any investigation.  The record consists primarily of a very short nurse’s note.  P. Ex. 6 at 8; P. Ex. 9 at 1.  Supposedly, unknown physicians may have speculated that the resident suffered a stroke while lying in bed, which caused him to fall out of bed, but no one offers any explanation as to how this could have occurred, and no evidence supports this theory.  CMS Ex. 6 at 12.  No physician or investigator examined the body before it was moved, (if a physician ever examined it).  There was no autopsy.

Page 18

I think it is unlikely that the resident simply had a stroke that caused him to fall out of bed.  The consensus was that he suffered a heart attack, not a stroke.  *See* CMS Ex. 1 at 3-4; P. Ex. 13 at 2; P. Ex. 15 (describing the cause of death as myocardial infarction).  Further, those who observed the body did not say that it was anywhere near the resident’s bed.  The notes simply say that he was on the floor.  P. Ex. 6 at 8; P. Ex. 9 at 1.  Inasmuch as staff reported that R1 made a practice of trying to get out of bed and was “agitated” that morning, it is more likely that he got out of bed, suffered a heart attack, and fell.  CMS Ex. 7 at 5; *see* CMS Ex. 15 at 5 (“[I]t is obvious that [R1] got up and fell to the floor.”).  In any event, CMS is not claiming that the fall caused R1’s death.  It accepts – as do I – that he died from a heart attack.  CMS does not argue that the facility’s deficiency caused actual harm; rather, it asserts that the deficiency posed the potential for more than minimal harm.  42 C.F.R. § 488.301.

**The mats**.  I find the question of whether fall mats were in place less significant than the parties seem to think.  The inadequacies in R1’s assessments and care planning, by themselves, establish that the facility was not eliminating or reducing foreseeable risks of accidents to the greatest degree practicable, which puts it out of substantial compliance with section 483.25(d).

Nevertheless, I find that facility staff understood that fall mats were called for when the resident was administered an anticoagulant.  As of September 4, R1 was administered an anticoagulant.  Yet, no fall mats were in place.

Based on the testimony of one witness, a housekeeper, Petitioner now claims that fall mats were in place.  P. Br. at 10.  In conflicting statements, the housekeeper asserts that the surveyor did not see the mats because the room had been partially cleaned and the mats removed before the surveyor arrived.  He is the only employee to make this claim, including those who were present when R1’s body was discovered.

In a handwritten, undated statement, the housekeeper says that he cleaned R1’s room on *September 4* but does not claim that fall mats were in place at that time.  He writes that he understood that the resident died the following day – September 5 – and he “provided boxes and bags to nursing employees” so that they could pack and store the resident’s personal items.  According to his statement, the facility policy is to deep clean the bed space after personal items are collected; however, the room did not require a deep cleaning.  He does not claim that he personally cleaned or removed any item after the resident’s death.  He writes that the “area” was wiped down and that “fall mat, chair, and water pitcher [were] removed” on September 5, but that other personal items remained.  P. Ex. 4.  He does not identify who removed the fall mats or explain how he knows that.  No one else has come forward to claim that he or she removed any mats from the room. Moreover, in his written declaration, the witness changes his testimony in one significant way.  He claims that he cleaned the resident’s room on *September 5, 2020*, and, because

Page 19

he was the purported cleaner, he implies, without actually saying, that *he* removed the fall mats*.*  P. Ex. 27.  That he changed his statement undermines the witness’s credibility.

But the testimony also fails because *every other employee and witness* who was in a position to know said that R1 had no mats in his room.  LVN A, who saw R1 face-down on the floor, told Surveyor Burnham that there was not a mat on the floor.  CMS Ex. 1 at 4.  Nurse Aide A, who worked with the resident, told the surveyor that R1 did not have floor mats.  Nurse Aide B said that R1 did not have floor mats.  CMS Ex. 1 at 4.11  Again, that the employees made these statements is unrefuted.  *See* *Beatrice State Developmental Ctr.*, DAB No. 2311 at 17, 18;*Omni Manor Nursing Home*, DAB No. 1920 at 11 (2004) (holding that the statements facility employees made to the surveyors may be admitted in an administrative proceeding and may constitute substantial evidence).

Moreover, if mats were in place, I would have expected some reference to them in the nurses’ notes or elsewhere in the record, as found in notes from August 21.  P. Ex. 2 at 1.  At a minimum, anyone describing the position of R1’s body when it was found should have noted that fall mats were in place.  It was in the facility’s interest to record that fall mats were in place – if they were – because it would have strengthened the claim that R1 was not injured as a result of the fall.  There is no such reference.  *See* P. Ex. 8; P. Ex. 9 at 1.

Ultimately, this case turns on what the facility was doing to prevent R1 from falling and to protect him from injury if he fell.  The evidence establishes that the facility was doing very little, and its inaction posed the potential for “more than minimal” harm to the resident, putting the facility out of substantial compliance with section 483.25(d).  42 C.F.R. § 488.301.

**The October 14, 2020 Survey**.

***The facility was not in substantial compliance with 42 C.F.R. § 483.80(a) because, contrary to facility policies, the facility did not affix the required signage to the doors of residents designated as on “droplet precautions.” It did not maintain containers for personal protective equipment (PPE) outside their doors, and the required gowns were not***Page 20

***available for staff entering the residents’ rooms.  Staff were reusing gowns**.*

**Program requirements: Section 1819(d)(3)** of the Social Security Act mandates that a skilled nursing facility must (A) establish and maintain an infection control program to provide a “safe, sanitary, and comfortable environment in which residents reside and to help prevent the development and transmission of disease and infection,” and (B) be designed, constructed, equipped, and maintained in a manner that protects the health and safety of residents, personnel, and the general public.

Consistent with section 1819(d)(3), **42 C.F.R. § 483.80(a)(1)(2)(4)(e)(f) (Tag F880)** requires the facility to establish and maintain an infection prevention and control program designed to provide a safe, sanitary, and comfortable environment and to help prevent the development and transmission of communicable diseases and infections.

The program must include:

a system for preventing, identifying, reporting, investigating, and controlling infections and communicable diseases for all residents, staff, volunteers, visitors, and other individuals providing services under a contractual arrangement based upon the facility assessment conducted according to § 483.70(e) and following accepted national standards;12
	written standards, policies, and procedures for the program, which must include: 
	a system of surveillance designed to identify possible communicable diseases or infections before they can spread to other persons in the facility;
		when and to whom possible incidents of communicable disease or other infections should be reported;
		*standard and transmission-based precautions to be followed* to prevent spread of infections;
		when and how isolation should be used for a resident, including:
		the type and duration of the isolation, depending upon the infectious agent or organism involved: andPage 21

a requirement that the isolation should be the least restrictive possible for the resident under the circumstances.the circumstances under which the facility must prohibit employees with a communicable disease or infected skin lesions from direct contact with residents or their food, if direct contact will transmit the disease; and
	the hand hygiene procedures to be followed by staff involved in direct resident contact.*  *  *  *  *

A system for recording incidents identified under the infection prevention and control program and the corrective actions to be taken by the facility.Personnel must handle, store, process, and transport linens so as to prevent the spread of infection.

The facility must also conduct an annual review of its infection prevention and control program and update the program, as necessary.

**CDC guidelines**.  In response to the Covid pandemic, the Centers for Disease Control and Prevention (CDC) warned that, given their “congregate nature” and the residents they serve (older adults, often with underlying chronic medical conditions), nursing home populations are at the “highest risk” of being affected by COVID-19.  If infected, residents are at increased risk of serious illness.  CMS Ex. 12 at 2; P. Ex. 32 at 1; *see* CDC Guidance:  People Who Live in a Nursing Home or Long-Term Care Facility available at https://stacks.cdc.gov/view/cdc/89837 (last visited Mar. 24, 2023).

The CDC recommends that facilities adhere to Standard and Transmission-Based precautions to prevent the transmission of infectious agents.  Standard precautions apply to the care of all patients in healthcare settings, regardless of whether an infectious agent is confirmed or expected.  Facilities apply Standard Precautions as their primary strategy to prevent the healthcare-associated transmission of infectious agents among patients and healthcare personnel.  CMS Ex. 12 at 1.

Facilities apply Transmission-Based Precautions for patients who are known or suspected to be infected or colonized with infectious agents, including certain epidemiologically important pathogens, which require additional control measures to effectively prevent transmission.

Page 22

Since the infecting agent often is not known at the time of admission to a healthcare facility, Transmission-Based Precautions are used empirically, according to the clinical syndrome and the likely etiologic agents at the time and then modified when the pathogen is identified or a transmissible infectious etiology is ruled out.

CMS Ex. 12 at 1.13  There are three categories of Transmission-Based Precautions:  Contact Precautions, Droplet Precautions, and Airborne Precautions.  CMS Ex. 12 at 3.  Droplet Precautions are intended to prevent transmission of pathogens that are spread through close respiratory or mucous membrane contact with respiratory secretions.  A single patient room is preferred for the resident, but, if a single room is not available, other options include cohorting or keeping the patient with an existing roommate.14  In that case, the patients should be separated by at least three feet, and a curtain should be drawn between beds.  Personnel with close contact to the patient must don a mask when entering the room.  CMS Ex. 12 at 4.

Because of the higher risk of unrecognized infection among residents, universal use of all PPE for the care of all residents in the affected unit (or facility-wide, depending on the situation) is recommended *when even a single case among residents or health care personnel is newly identified in the facility*.  This should also be considered when there is sustained transmission in the community.  P. Ex. 32 at 6.

Because roommates of residents with COVID-19 might already be exposed, “it is generally not recommended to place them with another roommate *until 14 days after their exposure*, assuming they have not developed symptoms or had a positive test.”  P. Ex. 32 at 6 (emphasis added).

**CDC guidelines:  new admissions**.  Depending on the prevalence of COVID-19 in the community, CDC guidelines direct facilities to keep new admissions and readmissions, whose COVID status is unknown, in separate observation areas.  Staff who interact with the new admissions should wear an N95 or higher-level respirator or face mask.  Staff should also wear *eye protection, gloves, and gowns when caring for these residents*.

Page 23

Residents can be transferred out of the observation area if they remain afebrile and without symptoms *for 14 days after admission*.  Testing *at the end of this period* can be considered to increase certainty that the resident is not infected.  P. Ex. 32 at 5.

Consistent with the CDC guidelines, during its staff training, the facility informed staff that residents returning from the emergency room or hospital would be placed *in isolation for 14 days*.  P. Ex. 20 at 12.

**Facility policies:  Infection control – droplet precautions.**  In the statement of deficiencies for the October 14 survey, CMS quotes an undated facility policy regarding droplet precautions.  In addition to “Standard Precautions,” the policy directs staff to use a droplet precaution sign for any resident “known or suspected to be infected with microorganisms transmitted by droplets that can be transmitted by the resident sneezing, coughing, talking, etc.”  Staff are required to maintain adequate supplies “per policy and needs of resident” and to *add signage to the resident’s door with the instructions:  “Contact Nurse Prior to Entering.”*  A PPE (personal protective equipment) isolation cart will be placed outside the resident room.  CMS Ex. 8 at 5-6 (emphasis added).15

Petitioner does not dispute that this policy was in effect at the time of the survey and has come forward with additional infection-control policies.

**Facility policy:  COVID-19**.  The facility’s COVID-19 policy provides that the health and well-being of facility residents will be protected during outbreaks of infectious diseases.  To achieve this, the policy calls for:

Strictly limiting visitation if the facility must be quarantined.  Among other limitations, any visitor must follow CDC guidelines;
	Vendors are not allowed in the facility;
	Emergency Medical Services and police are allowed in but must follow CDC guidelines;
	Only the administrator, at the direction of the medical director, is authorized to quarantine and modify the facility’s visitation privileges during infectious outbreaks.  *CDC guidelines will be followed during COVID-19*.
	Communal dining and group activities are cancelled.  Residents are reminded to practice social distancing and perform frequent hand hygiene.  *The facility will follow CDC guidelines and conduct in-service education to staff and residents*.Page 24

Residents are reminded to cover their mouth and nose when others enter their rooms;
	Dining is to be in individual resident rooms during COVID-19;
	All frequently touched (door knobs, light switches, call lights, etc.) areas are to be cleaned and disinfected a minimum of three times a day;
	*The facility will follow CDC guidelines during COVID-19 outbreaks in the community and in the event of an outbreak in the facility*.  It also developed its own procedures governing the management of outbreaks of communicable diseases, and copies of the procedures are available from the infection control coordinator and director of nursing services.P. Ex. 31.

**Facility policy:  droplet precautions**.  Petitioner submits a policy titled “Droplet Precautions.”  Dated 2012, it mentions influenza, mycoplasma pneumonia, and strep pharyngitis or pneumonia.  The policy applies to residents “with infections that can be transmitted by droplets,” although it does not address residents exposed to infection who have no symptoms or have not been diagnosed – which became a serious issue during the COVID pandemic.  P. Ex. 17.

**Facility policy:  contact precautions**.  Petitioner produces another 2012 policy titled “Contact Precautions.”  P. Ex. 22.  Its stated purpose is to use contact precautions in addition to standard precautions for residents known or *suspected to have* serious illnesses easily transmitted by direct resident contact or by contact with items in the resident’s environment.  Among other requirements, *a gown should be donned prior to entering the resident’s room and removed before leaving the room*.  After the gown is removed, clothing should not contact potentially contaminated surfaces.  P. Ex. 22 at 2.  The policy warns that the used “gown front and sleeves are contaminated.”  When removed, the policy instructs staff to “*hold removed gown away from body, roll into a bundle, and discard into waste or linen receptacle*.”  P. Ex. 22 at 4 (emphasis added).

**Facility failure to implement its infection control policies**.  The facility designated the “200” hall as what it now characterizes as its “Observation for New Admits” unit.16  At the time of the survey, staff told surveyors that all but two of the unit’s residents were in

Page 25

isolation, and they were supposed to be on droplet precautions.  The facility’s (then) administrator explained that she couldn’t transfer the two who were not on droplet precautions because she did not have rooms for them elsewhere.  CMS Ex. 8 at 6-7.  That staff made these statements is unrefuted.  *See Beatrice State*, DAB No. 2311 at 17, 18; *Omni Manor*, DAB No. 1920 at 11.

The parties agree that the facility was not following its policies for droplet precautions for this unit in three ways:

The facility’s policy required droplet precautions signs on the resident doors, instructing:  “Contact Nurse Prior to Entering.”  No such signs appeared on five of the doors in the unit (202, 203, 204, 206, and 207).  CMS Ex. 8 at 6.  LVN A could not explain why the signs were missing, although he told the surveyors that the residents in rooms 205 and 208 were not in isolation, which is why no signs were on their doors.  CMS Ex. 8 at 6-7.  LVN A has not denied making those statements.  *See Beatrice State*, DAB No. 2311 at 17, 18; *Omni Manor*, DAB No. 1920 at 11.
	PPE containers were not in place outside four of the rooms (202, 203, 204, 207).  CMS Ex. 8 at 6; *see* P. Ex. 32 at 4 (directing facilities to “[p]osition a trash can near the exit inside the resident room to make it easy for staff to discard PPE prior to exiting the room or before providing care for another resident in the same room.”).
	Gowns were not available for staff.  The surveyors observed nurse aides reusing or sharing gowns.  CMS Ex. 8 at 6; *see* P. Ex. 32 at 5 (specifying that the same gown should not be worn when caring for different residents unless the residents have confirmed COVID-19, are cohorted in the same area of the facility, and have no co-infections).  Nurse Aide C told surveyors that she wore the same gown throughout her shift.  She did not change it at any time.  CMS Ex. 8 at 6-7.Petitioner does not deny any of this.  I discuss below Petitioner’s overarching claim that it was not required to implement any of its COVID-prevention policies or adhere to CDC guidelines because the facility was COVID-free throughout the pandemic (which is not true).  *See* P. Cl. Br. at 18 (conceding the absence of droplet signs, while claiming, falsely, that “droplet precaution signs were available if needed in the event that a COVID-19 case did develop within the facility, which never occurred.”).

Petitioner also claims that, because of the PPE shortage, it was allowed to re-use gowns.  According to DON Preston (who did not work in the facility at the time), the facility re-used gowns “for gown prioritization” which the CDC allowed if PPE was in short supply.  P. Ex. 25 at 2 (Preston Decl.); P. Br. at 17.  Notably, she does not claim that the facility itself lacked PPE and was therefore unable to comply with its infection control policies.

Page 26

Instead, she cites to a general PPE shortage during the pandemic.  In fact, the limited evidence regarding the facility’s supply of PPE shows that the facility had sufficient PPE.  In its October 14, 2020 report to the National Healthcare Safety Network, the facility reported *no lack of PPE or other supplies*.  P. Ex. 21 at 2-3.

Moreover, even if the facility lacked sufficient PPE, it should not have resorted to *ad hoc* measures.  Instead, the facility’s professional staff and management were required to develop and implement written policies describing its response.  The record includes no evidence of any such policy.

To comply with section 483.80(a), the facility must have in place infection control policies, and it *must implement those policies*.  *Golden Living Ctr. – Superior*, DAB No. 2768 at 7 (2017); *Heritage House of Marshall Health & Rehab. Ctr*., DAB No. 2566 at 12 (2014).  Thus, where a facility’s medical director opted not to follow the facility policy to prescribe prophylactic medications, the Board found that the facility violated the infection control regulation.  *Golden Living*, DAB No. 2768 at 17.  Where, contrary to its policies, a facility failed to post a sign at the entrance to an infected resident’s room with instructions for those entering the room, the Board held that the facility did not comply with the infection control regulation.  *Heritage House*, DAB No. 2566 at 13.17

Because I find that the facility failed to follow CDC guidelines and its own infection-control policies, I find that the facility was not in substantial compliance with section 483.80(a).

**Petitioner’s defenses**.  According to Petitioner, the facility was not required to follow its infection control policies or the CDC guidelines because it instituted a different practice:  “***Every resident admitted to the facility – and on this observation unit specifically – had******a test confirming that the resident was COVID-19 negative upon admission to the facility***.”  P. Cl. Br. at 17 (double-emphasis in original).  If so (and Petitioner again does not support its claim), no evidence suggests that the facility acted pursuant to any written

Page 27

policy; Petitioner has not produced one.  Moreover, the practice is not consistent with CDC guidelines, which recommend testing at the *end* of the 14-day observation period (P. Ex. 32 at 5) and warn that a test may not be accurate if performed too soon after someone is exposed to COVID.  CDC Guidance:  COVID-19 Testing:  What You Need to Know available at https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/testing.html (last visited Mar. 24, 2023) .  Indeed, the CDC explains:

A single negative test upon admission does not mean that the resident was not exposed or will not become infected in the future.  Newly admitted or readmitted residents should still be monitored for evidence of COVID-19 for 14 days after admission and cared for using all recommended COVID-19 PPE.  **Testing should not be required prior to transfer of a resident from an acute-care facility to a nursing home.**

CDC Guidance:  Responding to Coronavirus (COVID-19) in Nursing Homes (last reviewed Apr. 30, 2020) available at https://web.archive.org/web/20200509021259/https://www.cdc.gov/coronavirus/2019-ncov/hcp/nursing-homes-responding.html (last visited Mar. 24, 2023).  Nevertheless, Petitioner touts the purported “success” of its approach. Petitioner claims that, contrary to what staff (including the then-administrator) told the surveyor, no one in the facility required transmission-based precautions.  According to Petitioner, “***Hill Country did not have one single positive COVID-19 case through the date of the 10/14/20 survey***.”  P. Cl. Br. at 16 (double emphasis in original).  It characterizes this “feat” as “remarkable” and argues that such an accomplishment:

can only be attributed to the fact that, contrary to the surveyor’s allegations, Hill Country went above and beyond what was required or recommended by CMS and the CDC in terms of infection control.  For the surveyor to be aware of this statistic and subsequently suggest that the facility did not have a properly functioning [Infection Prevention and Control Program] is absurd.

P. Cl. Br. at 16.

Petitioner also asserts that “it is remarkable that Hill Country was able to remain completely COVID-19 free*for the entirety of the pandemic*[,] given the incredible challenges facing nursing homes throughout the entire [S]tate of Texas.”  P. Cl. Br. at 18 (emphasis added).

In support of this claim that the facility remained COVID-free throughout the pandemic, Petitioner cites the following:

Page 28

a single weekly report that the facility submitted to the National Healthcare Safety Network on October 14, 2020, indicating that, for the prior week, the facility admitted or readmitted zero residents previously diagnosed with COVID-19 who continue to require transmission-based precautions; zero residents with new positive COVID-19 test results; zero residents with new suspected COVID; zero resident deaths for any reason; and zero deaths of residents with suspected or confirmed COVID-19.  P. Ex. 18 at 1.
	The same report indicates that, for the week ending October 14, 2020, no staff or facility personnel had suspected or confirmed COVID-19 and that none had died.  P. Ex. 18 at 3.
	The written declaration of Owner Robinson, who parrots, with the same emphasis, Petitioner’s claim that “***Hill Country did not have one single positive COVID-19 case through the date of the 10/14/20 survey***.”  He also proclaims that the “feat is remarkable and can only be attributed to the fact that, contrary to the surveyor’s allegations, Hill Country went above and beyond what was required or recommended by CMS and the CDC in terms of infection control.”  P. Ex. 24 at 2 (Robinson Dec1.).
	Another section of Owner Robinson’s written declaration that repeats “Hill Country *never had 1 single positive case of COVID-19 throughout the pandemic*, a feat in and of itself.  This is further evidence of Hill Country’s exceptional efforts to minimize the potential spread of pathogens from outside the facility to the residents in the protected, COVID-19 negative environment within the facility.”  P. Ex. 24 at 7 (Robinson Decl.) (emphasis added).
	An undated, handwritten statement from an LVN claiming that, on October 14, 2020, the facility had zero COVID-19 positive residents in the facility and that the “facility also never had any COVID-19 positive cases during the pandemic.”  P. Ex. 21 at 1.
	A written declaration from the Assistant Director of Nursing, LVN Cassada Gillis, claiming that the facility had no COVID-positive residents and that all new admissions and readmissions had a COVID-negative test.  P. Ex. 26; P. Ex. 34 (LVN Gillis’s undated statements claiming that the facility had no positive residents).That the facility did not have one single positive COVID-19 case throughout the pandemic is belied by the COVID data gathered by CMS and the state agency.  *See* P. Ex. 32 at 2 (directing facilities to report weekly, to the National Healthcare Safety Network,

Page 29

COVID-19 cases, facility staffing, and supply information).  That data shows the following:

Week of July 12, 2020:  **One staff member** contracted COVID.**Overall Total:  1 staff; 0 residents**.
	Week of July 19, a **second staff member** contracted COVID.**Overall Total:  2 staff; 0 residents**.
	Week of August 9, **a third staff member** contracted COVID. **Overall Total:  3 staff; 0 residents**.
	Week of August 16, **one resident** tested positive for COVID. **Overall Total:  3 staff; 1 resident**.
	Week of August 30, **two more residents** tested positive for COVID.**Overall Total:  3 staff; 3 residents**.
	Week of September 20, **the facility admitted a resident**who had tested positive for COVID and required transmission-based precautions. **Overall Total:  3 staff; 3 residents**.18
	Week of September 27, **one additional staff member** contracted COVID. **Overall Total:  4 staff; 3 residents**.
	Week of October 18, **one additional staff member** contracted COVID.**Overall Total:  5 staff; 3 residents**.ALJ Ex. 3 at 2; *accord* ALJ Ex. 1; ALJ Ex. 2.

Responding to this incontrovertible data – and disregarding its witness claims that the facility “never had 1 single positive case of COVID-19 throughout the pandemic” – Petitioner argues that “in no way” does the data “detract from the credibility and/or accuracy of Petitioner’s statements regarding no facility positive COVID case *during the relevant timeframe*.”  P. Response at 2.  Petitioner does not specify the “relevant time frame.”  Obviously, this hard data must detract from the accuracy of Petitioner’s claims and the credibility of at least two of its witnesses (Owner Robinson and LVN Gillis) who made claims that simply are not accurate.

Page 30

Petitioner also claims that “[t]he one week where a resident was reported as a COVID admit was a resident who tested negative at the time of admission, but who had tested positive at a previous facility (hospital) and had recovered.”  P. Response at 2.  Petitioner cites no support for this, which mischaracterizes what the facility was required to report.  The facility was not required to report residents admitted from another facility who had recovered from COVID and therefore did not require precautions.  It was required to report “residents admitted or readmitted from another facility who were previously diagnosed with COVID-19 and *continue to require transmission-based precautions*.”  P. Ex. 21 at 2 (emphasis added).

That the facility reported that this resident required transmission-based precautions suggests two possibilities.  Either the resident had not tested negative (and Petitioner provides no reliable evidence of a negative test, which it should easily have been able to produce) or the testing would not have been reliable.  Someone exposed to COVID-19 must wait at least five full days after exposure before testing.  Testing too early is more likely to give an inaccurate result.  CDC Guidance:  COVID-19 Testing:  What You Need to Know available at https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/testing.html (last visited Mar. 24, 2023).

Petitioner disregards entirely the three residents who were not reported as “new admissions,” but were reported as “residents_weekly_confirmed_covid.”  ALJ Ex. 1.  Facilities were required to report, weekly, the “[r]esidents with new positive COVID-19 test results from a viral test.”  P. Ex. 21 at 2.  This category is separate from the “ADMISSIONS” category.

The data thus shows that, for the week of August 16, 2020, one resident, who was not newly admitted, tested positive for COVID-19.  For the week of August 30, 2020, two additional residents tested positive for COVID-19.  The record is silent as to the course of their diseases.

Petitioner dismisses as unimportant its staff members who contracted COVID.  Petitioner claims, again without support, that they all contracted COVID “from the community outside the nursing home” and “quarantined and remained away from the facility for the applicable time frame.”  P. Response at 3.  The record includes no evidence establishing where or how staff contracted the disease.  But more important, given the nature of COVID, these staff members would have been infected with the highly contagious disease well before they tested positive.  As CDC guidelines explain, it can take up to 14 days for an infected person to show symptoms of infection, and some infected individuals never show symptoms, although they can transmit the disease.  Exposure can occur “from a suspected case or from a ‘person under investigation,’ when testing has not yet occurred, or if the testing results are pending but not expected for 48 to 72 hours.”  CDC Guidance:  Interim U.S. Guidance for Risk Assessment and Work Restrictions for Healthcare Personnel with Potential Exposure to COVID-19 (updated Jun. 18, 2020),

Page 31

available at https://web.archive.org/web/20200905050442/https://www.cdc.gov/coronavirus/2019-ncov/hcp/guidance-risk-assesment-hcp.html (last visited Mar. 24, 2023).  For this reason, the CDC guidelines call for “universal use of all recommended PPE” *when even a single resident or staff member contracts the disease*.  P. Ex. 32 at 6.

Thus, in the days or weeks before these staff members were diagnosed (July 12, July 19, August 9, September 27, and October 18), they were likely infected.  Any resident who had contact with one of them could have contracted the disease.  For that reason, those exposed residents should have been separated and on transmission-based precautions, as called for in the facility’s policies and CDC guidelines.

Thus, because the facility failed to follow CDC guidelines and its own infection control policies, it was not in substantial compliance with section 483.80(a).

***The penalties imposed – $22,320 per instance for violating section 483.25(d) (preventing accidents) and $15,000 per instance for violating section 483.80 (infection control) – are reasonable.***To determine whether a civil money penalty is reasonable, I apply the factors listed in 42 C.F.R. § 488.438(f):  (1) the facility’s history of noncompliance; (2) the facility’s financial condition; (3) factors specified in 42 C.F.R. § 488.404; and (4) the facility’s degree of culpability, which includes neglect, indifference, or disregard for resident care, comfort or safety.  The absence of culpability is not a mitigating factor.  The factors in 42 C.F.R. § 488.404 include:  (1) the scope and severity of the deficiency; (2) the relationship of the deficiency to other deficiencies resulting in noncompliance; and (3) the facility’s prior history of noncompliance in general and specifically with reference to the cited deficiencies.

I consider whether the evidence supports a finding that the amount of the CMP is at a level reasonably related to an effort to produce corrective action by a provider with the kind of deficiencies found, and in light of the section 488.438(f) factors.  I am neither bound to defer to CMS’s factual assertions nor free to make a wholly independent choice of remedies without regard for CMS’s discretion.  *Barn Hill Care Ctr.*, DAB No. 1848 at 21 (2002); *Cmty. Nursing Home*, DAB No. 1807 at 22 *et seq*. (2002); *Emerald Oaks*, DAB No. 1800 at 9 (2001); *CarePlex of Silver Spring*, DAB No. 1638 at 8 (1999).

The burden is on the facility “to demonstrate, through argument and the submission of evidence addressing the regulatory factors, that a reduction is necessary to make the CMP amount reasonable.”  *Heritage Plaza Nursing Ctr.*, DAB No. 2829 at 22 (2017) (quoting *Oaks of Mid City Nursing and Rehab. Ctr.*, DAB No. 2375 at 26-27 (2011)).

Page 32

Penalties are inflation-adjusted and change annually.  The amount is determined as of the date the penalty is assessed, in this case, December 9, 2020.  CMS Ex. 3; 85 Fed. Reg. 2869, 2880 (Jan. 17, 2020).  Here, CMS imposed a penalty of $22,320 per-instance for the deficiency cited under section 483.25(d) (accident prevention), which is the per-instance maximum, and $15,000 per-instance for the deficiency cited under section 483.80(a) (infection control), which is in the mid-to-high end of the penalty range ($2,233 to $22,320).  42 C.F.R. §§ 488.408(d), 488.438; 45 C.F.R. § 102.3; 85 Fed. Reg. 2869, 2880 (Jan. 17, 2020).

Considering what CMS might have imposed – a comparable per-day penalty for multiple days of substantial noncompliance – these penalties are modest.  *See Plum City Care Ctr.*, DAB No. 2272 at 18-19 (2009) (observing that even the maximum per-instance CMP can be “a modest penalty when compared to what CMS might have imposed.”).19

Considering the relevant factors, these amounts are reasonable.

The facility has a less-than-stellar history, which includes findings of substantial noncompliance with the infection control regulation in its last two recertification surveys.  For the survey ending May 11, 2019, CMS determined that the facility was not in substantial compliance with section 483.80(a), cited at scope-and-severity level D (isolated instance of substantial noncompliance that causes no actual harm, with the potential for more than minimal harm).  For the survey ending May 4, 2018, it was not in substantial compliance with section 483.80(a), cited at scope-and-severity level E (pattern substantial noncompliance that causes no actual harm, with the potential for more than minimal harm).  CMS Ex. 15 at 8 (McElroy Decl.).20

Petitioner does not claim that its financial condition affects its ability to pay the penalties.

**The $22,320 per-instance penalty**.  With respect to the remaining factors, I have discussed in some detail the multiple ways in which facility staff failed to protect R1. His assessments disregarded or mischaracterized his significant risks, including the fact that he had experienced a fall.  Inadequate assessments led to inadequate care planning.  Following his hospitalization, staff behaved as if his condition would not have increased

Page 33

his risk of injury from accidents.  Staff recognized – the point having been emphasized by his nurse practitioner – that so long as he was taking anticoagulants, he was a risk of serious injury from a fall.  Yet, they either didn’t realize that he was again taking anticoagulants, or they disregarded that factor.  This shows indifference to his safety, for which the facility is culpable.

CMS could have imposed a per-day penalty from at least the time of his inadequate July 16, 2020 assessment through the day of his death on September 5, 2020.  Even assuming the minimum ($2,233 per day), the total penalty for that deficiency ($116,116) would have been far greater than the $22,320 that was imposed.  *See Plum City*, DAB No. 2272 at 18-19.

Petitioner argues that the amount of the penalty should be reduced because no one was injured as a result of the substantial noncompliance, and it affected only one resident.  Although CMS determined that R1’s fall did not cause his death (and thus cited the deficiency at scope a severity level D), the danger posed by the facility’s inadequate response to his risks of injury was real.  P. Br. at 19.  That CMS imposed a per-instance rather than a per-day penalty, necessarily meant that even the maximum penalty would be minimal.

Petitioner also argues that the facility was not culpable.  The evidence does not support this claim.  In any event, the absence of culpability is not a mitigating factor.  42 C.F.R. § 488.438(f)(4).

**The $15,000 per-instance penalty**.  The impact of the facility’s substantial noncompliance with the infection-control regulation was not limited to one resident; it showed a pattern of substantial noncompliance.  As my colleague has noted, in the Age of COVID, a facility’s failing to comply with infection prevention and control requirements “puts its residents at great risk.”  *Crouse Community Ctr., Inc.*, DAB CR6028 at 20 (2022).

Here, the facility had in place policies that, consistent with CDC guidelines, required it to affix signage to the doors of residents who were designated to be on “droplet precautions.”  Facility policies required it to maintain, for each resident room, a container for disposing of PPE.  Staff were required to don gowns before entering a resident’s room and to remove the gown before leaving, hold the used gown away from the body, and discard it into the receptacle.  As discussed above, staff did not comply with any of these policies, for which the facility is culpable.

Petitioner again argues that, because the facility adhered to its policies and to CDC guidelines, it is not culpable and should not be subject to a penalty.  As the above discussion establishes, facility staff did not follow CDC guidelines or the facility’s policies.

Page 34

Petitioner has thus not met its burden of establishing that reductions are necessary to make the CMP amounts reasonable.

Conclusion

The facility was not in substantial compliance with 42 C.F.R. §§ 483.25(d) and 483.80(a).  The penalties imposed are reasonable.

Endnotes

1   Deciding a case based on the written record does not mean that it is decided without a hearing.  In reviewing administrative appeals, courts recognize that, by considering the evidence and applying the law, the ALJ has granted the petitioner a hearing, even if that hearing was not an “oral” or “evidentiary” hearing.  *See* *CNG Transmission Corp. v. FERC*, 40 F.3d 1289, 1293 (D.C. Cir. 1994) (holding that a “paper hearing” satisfies statutory requirements for “notice and opportunity for hearing.”).

2   My findings of fact/conclusions of law are set forth, in italics and bold, in the discussion captions of this decision.

3   Because of his high risk, the facility was required to initiate a prevention protocol and to document that protocol in the resident’s care plan.  P. Ex. 11 at 2.  The record here includes no evidence of how the facility responded to the June assessment – if it did.  Although Petitioner submitted a partial care plan, it includes only the interventions in place (and cancelled) in September 2020.  P. Ex. 1.

4   Throughout his stay at the facility, R1 took Zoloft, an antidepressant that can cause dizziness and drowsiness.  P. Ex. 3 at 23.  He took the opioid, Ultram, which can cause lightheadedness, dizziness, and drowsiness.  P. Ex. 3 at 22.  Even his blood pressure medications – Lopressor and Amlodipine Besylate – can cause dizziness and lightheadedness.  P. Ex. 3 at 19, 20.

5   The facility’s policy requires staff to investigate falls and to prepare an incident report and post-fall assessment.  P. Ex. 11 at 3, 4.  The record includes no incident report or post-fall assessment for the July 17 fall.  The surveyor also reported that R1’s care plan did not address his fall risk.  CMS Ex. 1 at 2.  The record contains a care plan, but it includes no interventions dated before September 5, 2020.  P. Ex. 1.  The record contains no evidence showing what – if anything – the facility did in response to the July 17 fall.

6   The orders regarding R1’s transfer to the hospital support the notion that the orders were all cancelled automatically, not circumspectly.  The order for an ambulance to take him to the hospital on September 2, is marked as discontinued on both September 2 and September 4.  P. Ex. 3 at 18; *but see* P. Ex. 6 at 1 (which appears to be a September 2 order that cancels the order to transfer the resident to the hospital on September 2, which had already occurred).

7   That he was on Heparin did not increase R1’s fall risk; however, it significantly increased his risk that a fall would cause him serious injury.  Fall mats are used as an intervention to prevent “foreseeable risks of harm from accidents.”  *See Briarwood*, DAB No. 2115 at 5.

8   In arguing that the Heparin order had been discontinued, Petitioner string cites to the record, but those citations do not include either P. Ex. 3 at 5 or P. Ex. 7 at 3, where the September 4 Heparin order is found.  *See* P. Cl. Br. at 9 (citing P. Exs. 6, 25, 5, 33).

9   Symptoms of unsteady bradycardia include confusion, dizziness or lightheadedness, fatigue, fainting, and shortness of breath, any one of which could increase the resident’s risk of falls.

10   Owner Robinson began working at the facility in January 2021.  P. Ex. 24 at 1 (Robinson Decl.).  DON Preston began working at the facility on June 1, 2021.  P. Ex. 25 at 1 (Preston Decl.).

11   Curiously, Owner Robinson and DON Preston disagree on whether fall mats were in place.  Owner Robinson claims that they were (P. Ex. 24 at 5), but DON Preston testifies that “no floor mats” were in the room.  P. Ex. 25 at 1; *see* P. Ex. 33 at 1, 4.  As noted above, neither of these witnesses was at the facility or in the room at the time, and – unlike the staff members who were caring for R1 – neither is in a position to know what, if anything, was on the floor.  *See W. Tex. LTC Partners, Inc.*, DAB No. 2652 at 14.

12   Section 483.70(e) mandates that the facility conduct and document a facility-wide assessment to determine what resources are necessary to care for its residents competently during both day-to-day operations and emergencies.

13   Using precautions “empirically” means that use is based on experience, without precise knowledge of the cause or nature of a disorder.  An etiologic agent is a viable microorganism or its toxin that causes or may cause disease.

14   Cohorting refers to grouping individuals with the same condition in the same location (room, wing, building).  For COVID purposes, this means residents who are COVID-positive or suspected of having COVID remain in the same space, separate from those who are COVID-negative or haven’t been exposed to COVID.  Cohorting is important to control the spread of the virus.  *See* P. Ex. 32 at 5.

15   Throughout both of its briefs, CMS misidentified this exhibit as CMS Ex. 9.

16   The surveyor characterized the unit as “Isolation for Presumption of Covid Hall 200.”  CMS Ex. 8 at 6.  Based on her conversations with staff, the characterization seems apt.  *See* CMS Ex. 8 at 6-7.

17   The Board’s decisions in *Golden Living* and *Heritage House* are consistent with a long line of quality-of-care cases holding that CMS “may reasonably rely on a facility’s policy relating to the care and treatment of its residents as evidencing the facility’s understanding of what must be done to attain or maintain the residents’ highest practicable physical, mental, and psychosocial well-being, as required by [42 C.F.R.] section 483.25.”  *Green Valley Healthcare and Rehab. Ctr.*, DAB No. 2947 at 6 (2019) (citing *Laurels at Forest Glenn*, DAB No. 2182 at 18 (2008)); *North Las Vegas Care Ctr.*, DAB No. 2946 at 6 (2019); *Hanover Hill Health Care Ctr.*, DAB No. 2507 at 6 (2013) (observing that “the Board has long held that a facility’s own policy may be sufficient evidence . . . of what the facility has determined is needed to meet the quality-of-care requirements in section 483.25.”).

18   For reasons that are not explained, this seemingly additional resident testing positive for COVID-19 did not add to the facility’s total cases.

19   The penalty could have been as high as $6,695 per day for multiple days.  85 Fed. Reg. 2869, 2879.

20   CMS apparently has a policy of disregarding past substantial noncompliance unless it caused actual harm or immediate jeopardy.  CMS Br. at 19.  I am not bound by that policy; I am bound by the statute and regulations, which direct me to consider “the facility’s prior history of noncompliance history in general and specifically with reference to the cited deficiencies.”  42 C.F.R. §§ 488.404(c)(2) and 488.438(f)(1), (3).
  
          /s/
        Carolyn Cozad Hughes

                      Administrative Law Judge Back to top
    Contact HHS
    
                        
                                            
      
      
      Careers
    
                        
                                            
      
      
      HHS FAQs
    
                        
                                            
      
      
      Nondiscrimination NoticeHHS Archive
    
                        
                                            
      
      
      Accessibility Statement
    
                        
                                            
      
      
      Privacy Policy
    
                        
                                            
      
      
      Viewers & PlayersBudget/Performance
    
                        
                                            
      
      
      Inspector General
    
                        
                                            
      
      
      Web Site Disclaimers
    
                        
                                            
      
      
      EEO/No Fear ActFOIA
    
                        
                                            
      
      
      The White House
    
                        
                                            
      
      
      USA.gov
    
                        
                                            
      
      
      Vulnerability Disclosure Policy
        Sign Up for Email Updates

Receive the latest updates from the Secretary, Blogs, and News Releases.

Sign Up
  HHS Headquarters
          200 Independence Avenue, S.W.
                  Washington, D.C. 20201
                  Toll Free Call Center: 1-877-696-6775​ Disclaimer Policy: Links with this icon () mean that you are leaving the HHS website. The Department of Health and Human Services (HHS) cannot guarantee the accuracy of a non-federal website.
                  Linking to a non-federal website does not mean that HHS or its employees endorse the sponsors, information, or products presented on the website. HHS links outside of itself to provide you with further information.
                  You will be bound by the destination website's privacy policy and/or terms of service when you follow the link.
                  HHS is not responsible for Section 508 compliance (accessibility) on private websites. For more information on HHS's web notification policies, see Website Disclaimers.
 Continue
                  Go back