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
                              2021
                              Lutheran Home, DAB CR5922 (2021)
 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

                    




Lutheran Home, DAB CR5922 (2021)








  
  
    

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





Lutheran Home,
(CCN: 52-5545),
Petitioner,

v.

Centers for Medicare & Medicaid Services.
Docket No. C-19-922Decision No. CR5922August 12, 2021

        
              
    

      DECISION

Lutheran Home (Petitioner or facility) is a nursing facility, located in Wauwatosa, Wisconsin, that participates in the Medicare program.  Based on a survey completed on March 6, 2019, the Centers for Medicare & Medicaid Services (CMS) determined that the facility was not in substantial compliance with program participation requirements and imposed a $17,350 per instance civil money penalty (CMP).1
  Petitioner here challenges that determination and CMS now moves for summary judgment.

For the reasons discussed below, I find that summary judgment is appropriate.  Based on the undisputed evidence, I conclude that the facility was not in substantial compliance

**Page 2**

with Medicare requirements governing quality of care, 42 C.F.R. § 483.25, and I affirm, as reasonable, the imposition of a $17,350 per instance CMP.

I.    Background

The Social Security Act (Act) sets forth requirements for nursing facility participation in the Medicare program, and authorizes the Secretary of Health and Human Services to promulgate regulations implementing the 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 with program participation requirements.  Act § 1864(a); 42 C.F.R. § 488.20.  The regulations require that each facility be surveyed once every twelve months, and 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.

In this case, surveyors from the Wisconsin Department of Health Services (WDHS) conducted a complaint investigation survey from February 26, 2019 to February 28, 2019, and a partial extended survey was conducted on March 6, 2019.  CMS Ex. 1 at 1; *see* CMS Ex. 5 at 1.  Based on the survey findings, CMS determined that the facility was not in substantial compliance with federal requirements for nursing homes participating in the Medicare and Medicaid programs, and a deficiency existed which posed immediate jeopardy to resident health and safety.  Specifically, they found that the facility did not meet federal requirements under:  42 C.F.R. § 483.25 (Tag F684 – Quality of Care), and 42 C.F.R. § 483.25(d)(1)(2) (Tag F689 – Free of Accident Hazards/Supervision/Devices).  CMS Exs. 1, 5.  CMS imposed a per instance CMP of $17,350 for the deficiency cited under 42 C.F.R. § 483.25.

Petitioner timely requested a hearing.  On July 11, 2019, Judge Bill Thomas issued an Acknowledgment and Pre-hearing Order (APHO), setting forth prehearing procedures.2
  Both parties filed their pre-hearing exchanges, including prehearing briefs.  In its brief, CMS filed a motion for summary judgment (CMS Pre-Hearing Brief).  Petitioner filed a responsive brief, in which it opposed summary judgment (P. Pre-Hearing Brief).  With its motion and brief, CMS has submitted fourteen proposed exhibits (CMS Exs. 1-14).  With its response, Petitioner has submitted ten proposed exhibits (P. Exs. 1-10).  As neither

**Page 3**

party objected to any of the proposed exhibits, I admit CMS Exs. 1-14 and P. Exs. 1-10 into the record.

II.   Issues

I consider whether summary judgment is appropriate.  On the merits, the issues before me are:  1) whether the facility was in substantial compliance with 42 C.F.R. § 483.25 (quality of care); and 2) if the facility was not in substantial compliance, is the penalty imposed, $17,350 per instance, reasonable?

Because CMS imposed no penalties for the deficiency cited under a subsection of the quality of care regulation, 42 C.F.R. § 483.25(d)(1)(2), Free of Accident Hazards/Supervision/Devices, the facility’s compliance with that requirement is not before me.  42 C.F.R. § 498.3(d)(10)(ii); *Schowalter Villa*, DAB No. 1688 (1999) (The imposition of a remedy, not the citation of a deficiency, triggers the right to a hearing.).

Nor may I review CMS’s immediate jeopardy determination.  An administrative law judge may review CMS’s scope and severity findings, which include a finding of immediate jeopardy, only if a successful challenge would affect the **range** of the CMP assessed or CMS has made a finding of substandard quality of care that results in the loss of approval of a facility’s nurse aide training program.  42 C.F.R. § 498.3(b)(14), (d)(10); *see Evergreen Commons*, DAB No. 2175 (2008); *Aase Haugen Homes, Inc.,*DAB No. 2013 (2006).  As noted above, the penalty imposed here is a per instance CMP, for which the regulations provide only one range ($2,140 to $21,393).  42 C.F.R. § 488.438(a)(2); 45 C.F.R. § 102.3 (2018); 83 Fed. Reg. 51,369, 51,380 (Oct. 11, 2018).  This is in contrast to a per day CMP, which, by regulation, consists of two **ranges** of penalties, an upper range and a lower range.  42 C.F.R. § 488.438(a)(1).  Because CMS imposed a per instance CMP, a successful challenge to CMS’s immediate jeopardy finding would not affect the range of the CMP that CMS could collect.  *NMS Healthcare of Hagerstown,*DAB No. 2603 at 6-7 (2014), *appeal dismissed, NMS Healthcare of Hagerstown, LLC v. U.S. Dep’t of Health & Human Servs.,*619 F. App’x 225 (4th Cir. 2015).  Nor does CMS’s scope and severity finding affect approval of a nurse aide training program.  There is no evidence that Petitioner had a nurse aide training program.  However, even if it had, when a facility has been assessed a CMP of $10,697 or more, as has occurred here, the state agency may not approve its nurse aide training program.  42 C.F.R. § 483.151(b)(2)(iv).  For these reasons, I conclude that I have no authority to review CMS’s finding of immediate jeopardy.

**Page 4**

III.   Discussion

***A.  Because the undisputed facts establish that facility staff did not ensure that residents received treatment and care in accordance with professional standards of practice, the facility was not in substantial compliance with 42 C.F.R. § 483.25, and CMS is entitled to summary judgment.3***

Summary judgment is appropriate if a case presents no genuine issue of material fact, and one party is entitled to judgment as a matter of law.  The moving party may show the absence of a genuine factual dispute by presenting evidence so one-sided that it must prevail as a matter of law, or by showing that the non-moving party has presented no evidence “sufficient to establish the existence of an element essential to [that party’s] case, and on which [that party] will bear the burden of proof at trial.”  *Livingston Care Ctr. v. Dep’t of Health & Human Servs.,*388 F.3d 168, 173 (6th Cir. 2004) (quoting *Celotex Corp. v. Catrett*, 477 U.S. 317, 323-24 (1986)).  To avoid summary judgment, the non-moving party must then act affirmatively by tendering evidence of specific facts showing that a dispute exists.  *Matsushita Elec. Indus. Co. v. Zenith Radio Corp.,*475 U.S. 574, 586 n.11 (1986); s*ee also Vandalia Park,*DAB No. 1939 (2004); *Lebanon Nursing & Rehab. Ctr.,*DAB No. 1918 (2004).  In examining the evidence for purposes of determining the appropriateness of summary judgment, I must draw all reasonable inferences in the light most favorable to the non-moving party.  *Livingston Care Ctr.,*388 F.3d at 172; *Guardian Health Care Ctr.,*DAB No. 1943 at 8 (2004).  However, drawing factual inferences in the light most favorable to the non-moving party does not require that I accept the non-moving party’s legal conclusions.  *Cf. Guardian*, DAB No. 1943 at 11 (“A dispute over the conclusion to be drawn from applying relevant legal criteria to undisputed facts does not preclude summary judgment if the record is sufficiently developed and there is only one reasonable conclusion that can be drawn from those facts.”).

The relevant facts in this case are not in dispute.  CMS has come forward with evidence, primarily from the facility’s own records, establishing that4

**Page 5**

On January 19, 2019, Resident #2 was an 81-year-old woman, with diagnoses of functional quadriplegia, vascular dementia with behavioral disturbance, anxiety disorder, dysphagia following nontraumatic subarachnoid hemorrhage, history of aspiration pneumonia, and hemiplegia and hemiparesis following cerebral infarction.  P. Ex. 4 at 1; CMS Ex. 1 at 3.Events of January 19, 2019

At approximately 12:30 PM, Resident #2 vomited5
 in the dining room.  P. Ex. 1 at 2.  A licensed practical nurse (LPN) took her vital signs at that time, which were reported to be normal.6
  P. Ex. 1 at 2; P. Pre-Hearing Brief at 7.
	At approximately 1:30 PM, after being returned to her room, Resident #2 was reported to have had a second episode of vomiting and a loose stool.7
  P. Ex. 1 at 2; P. Pre-Hearing Brief at 8.8
  An LPN noted congestion, oxygen saturation level (SpO2) at 82%, blood pressure of 144/62, respirations at 20, and temperature of 100.6.  CMS Ex. 8 at 3; P. Ex. 1 at 2.  She was started on oxygen (O2) at two liters and Tylenol9
 for the fever and placed in isolation because of a norovirus outbreak in the facility.  P. Ex. 1 at 2; P. Ex. 3 at 2; P. Ex. 8 at 2; CMS Ex. 8 at 3.
	At approximately 1:31 PM, a call was made to Optum, which was under contract to provide clinical support and physician referral services to Petitioner.  P. Ex. 1 at 2; CMS Ex. 6.  The Optum record of the call indicates the resident was reported to have had a large emesis after lunch and a second one after being returned to her**Page 6**

room.  Among the vital signs reported were:  blood pressure of 170/6810
,  temperature of 98.2, and O2 level of 96%.  CMS Ex. 6.

At approximately 3:15 PM, an RN went to Resident #2’s room, saw the isolation cart outside the room and reportedly did not enter the room, but instead conducted a visual assessment and observed that she was resting comfortably and in no apparent respiratory distress.  CMS Ex. 1 at 14; P. Ex. 1 at 2; P. Ex. 3 at 2-3.  Resident #2’s daughter and health care agent indicated her mother was “just fine” at that time so the RN went to check on other residents.  P. Pre-Hearing Brief at 9.
	At approximately 3:50 PM to 4:10 PM, an LPN returned to Resident #2’s room after staff reported she experienced a third emesis and another loose stool.  P. Ex. 1 at 3; P. Pre-Hearing Brief at 9.  At that time, she performed an assessment which revealed Resident #2 was again congested, O2 was 82%, respirations were at 50, and temperature was 98.5.11
  Oxygen was raised to 4.5 liters and administered via an oxygen mask, with Resident #2’s oxygen levels fluctuating from 84% to 89%.  The RN then returned to perform an assessment, which revealed SpO2 remained at 82% on 4.5 liters via mask, respirations at 50, and rhonchi were noted in all lung fields.  CMS Ex. 8 at 2; P. Ex. 1 at 3.  The daughter requested that Resident #2 be sent to the hospital and a call was placed to Optum for an order to send the resident to the ER for evaluation.  P. Ex. 1 at 3; P. Pre-Hearing Brief at 10; CMS Ex. 6.
	An ambulance arrived at 5:09 PM, after being called at 4:51 PM, and a second ambulance was called because of an inability to establish an IV.  P. Ex. 1 at 3.  Resident #2 was admitted to the ER with a diagnosis of pneumonitis due to inhalation of food and vomit.  CMS Ex. 1 at 8; CMS Ex. 12 at 22.  She was placed on a ventilator and admitted to the intensive care unit with diagnoses of severe sepsis with septic shock, pneumonitis due to inhalation of food and vomit, and acute respiratory failure with hypoxia.  CMS Ex. 1 at 8.  Resident #2 remained on**Page 7**

the ventilator for three days and then received hospice care until she died on January 26, 2019.  CMS Ex. 1 at 8.

As noted above, Lutheran Home was charged with a violation of 42 C.F.R. § 483.25.  The opening provision of that section of the regulations, which implements sections 1819(b)(2) (Medicare) and 1919(b)(2) (Medicaid) of the Act, states:

Quality of care is a fundamental principle that applies to all treatment and care provided to facility residents.  Based on the comprehensive assessment of a resident, the facility must ensure that residents receive treatment and care in accordance with professional standards of practice, the comprehensive person-centered care plan, and the resident’s choices . . . .

42 C.F.R. § 483.25.  The subsections of that regulation then set forth specific requirements relating to particular types of care, services, and resident needs.  Based on the legislative history and the implementing regulations, the Board has previously stated that the quality of care requirement is “based on the premise that the facility has (or can contract for) the expertise to first assess what each resident’s needs are (in order to attain or maintain the resident’s highest practicable functional level) and then to plan for and provide care and services to meet the goal.”  *Spring Meadows Health Care Ctr.,*DAB No. 1966 at 11 (2005).  The regulation thus “imposes on facilities an affirmative duty designed to achieve favorable outcomes to the highest practicable degree.”  *Windsor Health Care Ctr.*, DAB No. 1902 at 16-17 (2003), *aff’d, Windsor Health Care Ctr. v. Thompson*, No. 04-3018 (6th Cir. 2005);*see* *Woodstock Care Ctr.*, DAB No. 1726 at 25-30 (2000), *aff’d sub nom.* *Woodstock Care Ctr. v. Thompson*, 363 F.3d  583 (6th Cir. 2003).  As the Board has previously observed, the regulatory requirements “are designed to focus on evaluating actual facility performance in meeting the purposes of the program and to move away from simply imposing checklists of capacities and services that must be available.”  *Koester Pavilion,* DAB No. 1750 at 25-26 (2000), citing *Woodstock,*DAB No. 1726 at 28-29.  The quality of care provision also implicitly imposes on facilities a duty to provide care and services that, at a minimum, meet accepted professional standards of quality “since the regulations elsewhere require that the services provided or arranged by the facility must meet such standards.”  *Spring Meadows,*DAB No. 1966 at 11, citing42 C.F.R. §§ 483.25, 483.75.

In this case, CMS has alleged that Petitioner was not in substantial compliance with 42 C.F.R. § 483.25 because it failed to ensure that Resident #2 received a Registered Nurse (RN) assessment and appropriate medical care at approximately 1:30 PM, when it asserts she had a significant change in her medical condition.  CMS Pre-Hearing Brief at 8, 12.  Petitioner argues that Resident #2 did receive appropriate medical treatment and care consistent with professional standards of care and a formal assessment by an RN

**Page 8**

was not required until approximately 3:50 PM to 4:10 PM, when there was an “acute” or “significant” change in Resident #2’s condition.  P. Pre-Hearing Brief at 16-17.

Both parties agree that an RN assessment is required when a resident experiences a significant change in condition.12
  Further, both parties agree that Resident #2 experienced a significant change of condition at some point on January 19, 2019.  However, as indicated above, the parties strenuously disagree as to *when* the significant change of condition occurred in this case.  The pivotal question in this case then becomes at what point was Resident #2’s condition such that an assessment by an RN was required under professional standards of practice.

It is initially noted that the terms “significant change of condition” or “acute change of condition” do not appear in 42 C.F.R. § 483.25.  Rather, that section of the regulations sets forth “professional standards of practice” as the standard by which a facility’s treatment and care is to be evaluated.

Based on the comprehensive assessment of a resident, the facility must ensure that residents receive treatment and care in accordance with professional standards of practice, the comprehensive person-centered care plan, and the resident’s choices . . . .

42 C.F.R. § 483.25.

Petitioner asserts that it complied with the American Medical Directors’ Association (AMDA) guidelines for an RN assessment for an Acute Change of Condition, in essence arguing that this is the standard to be used in determining whether the care provided met professional standards of practice.13
  P. Pre-Hearing Brief at 16-17.  These guidelines

**Page 9**

were considered in assessing whether professional standards of practice were met in this case but I have also considered related regulatory language, the provisions contained in CMS Pub. 100-07,  State Operations Manual (SOM), Appendix PP-Guidance to Surveyors for Long Term Care Facilities, and guidance provided in Board decisions.14

While 42 C.F.R. § 483.25 does not utilize “significant change of condition” as a standard for assessing the quality of care provided, other sections of the regulations do reference and define this term.  42 C.F.R. § 483.20(b)(2)(ii)15
 requires a “comprehensive assessment” when

there has been a significant change in the resident's physical or mental condition. (For purposes of this section, a “significant change” means a major decline or improvement in the resident’s status that will not normally resolve itself without further intervention by staff or by implementing standard disease-related clinical interventions, that has an impact on more than one area of the resident’s health status, and requires interdisciplinary review or revision of the care plan, or both.).

**Page 10**

42 C.F.R. § 483.20(b)(2)(ii).  I note that the SOM guidance concerning 42 C.F.R. § 483.20(b)(2)(ii) (the corresponding tag is Tag F637) defines “significant change” consistent with the regulatory text:

a major decline or improvement in a resident’s status that 1) will not normally resolve itself without intervention by staff or by implementing standard disease-related clinical interventions; the decline is not considered “self-limiting” (NOTE: Self-limiting is when the condition will normally resolve itself without further intervention or by staff implementing standard clinical interventions to resolve the condition.); 2) impacts more than one area of the resident’s health status; and 3) requires interdisciplinary review and/or revision of the care plan.

SOM, App’x PP at 192.

Further, 42 C.F.R. § 483.10(g)(14)(i)(B) requires a facility to immediately consult with the resident’s physician when there has been a “significant change in the resident’s physical, mental, or psychosocial status (that is, a deterioration in health, mental, or psychosocial status in either life-threatening conditions or clinical complications).”  While recognizing that the above cited regulations are not directly applicable in this case, they are considered as guidance in determining the appropriate analysis here.

Although not cited by Petitioner, the definition of an acute change of condition contained in the AMDA guidelines is “a sudden, clinically important deviation from a patient’s baseline in physical, cognitive, behavioral, or functional domains.”  P. Ex. 9 at 7.  The AMDA guidelines state further that “[c]linically important” means a deviation that, “without intervention, may result in complications or death.”  P. Ex. 9 at 7.

Applying these standards to the undisputed facts of this case, I note that Resident #2’s baseline functioning was recorded regularly in Petitioner’s Observation Detail List Report over a period of several weeks from December 2018 through January 2019.  CMS Ex. 9.  During the period from December 6, 2018 through January 17, 2019, her temperature ranged from 97.3 to 98.2, her respiration rates ranged from 15 to 18 per minute, O2 saturation levels ranged from 94% to 96%, and her blood pressure readings ranged from 110/63 to 130/64.  CMS Ex. 9 at 3, 8, 13, 28, 33.  Her vital signs were reportedly normal when checked after the first emesis in the dining room on January 19, 2019, at approximately 12:30 PM.  P. Ex. 1 at 2.  Less than one hour later16
, or by 1:30

**Page 11**

PM at the latest, her vital signs were checked again, and her O2 levels had dropped to 82%, temperature had increased to 100.6 degrees, and she was observed to be congested.  CMS Ex. 8 at 3.  She had also vomited at least twice and had at least one loose stool, after having had a large, regular bowel movement (BM) in the morning.  CMS Ex. 8 at 3; CMS Ex. 6.  The findings recorded at 1:30 PM clearly constitute “a sudden, clinically important deviation” from her baseline functioning and a “major decline” in her physical status.  These findings also required medical intervention to avoid complications and to attempt to resolve the condition, as evidenced by the fact that interventions, in the form of oxygen and Tylenol, were provided.  As a result, I find that they documented a significant or acute change in Resident #2’s condition, at 1:30 PM.

Petitioner argues that these findings did not represent an acute or significant change of condition because respirations were good and Resident #2 displayed no physical signs of respiratory distress that would require an assessment by an RN.  P. Pre-Hearing Brief at 17-18.  Petitioner fails to note, however, that the LPN doing the assessment at 1:30 PM did indicate “[c]ongestion noted at this time,” suggesting some potential lung involvement.  CMS Ex. 8 at 3.  Moreover, Petitioner appears to base the conclusion that there was no acute or significant change of condition until around 3:50 PM to 4:10 PM *solely* on the normal respiration rate at 1:30 PM.17
  However, at the same time, Resident #2 was exhibiting other new and concerning findings, including fever, reduced oxygen levels, congestion, vomiting, and loose stools, that would merit an RN assessment, even if some vital signs remained normal.  A sudden increase in temperature, “acute onset of multiple stools with change in vital signs,” and vomiting can be signs of an acute change of condition, according to the AMDA guidelines.  P. Ex. 9 at 18, 22.  The Board has also noted that a sudden drop in oxygen saturation levels and a fever can be evidence of a significant decline.  *Emery Cty. Care & Rehab. Ctr.,*DAB No. 3006 (2020) at 12.  In *Emery County Care*, the Board indicated that a decrease in blood oxygen saturation level from previously normal levels after an event could be “in and of itself a warning of a potentially grave medical development” and constitute “a sharp departure from the resident’s normal state.”  *Emery*at 10.  Moreover, the Director of Nursing (DON) stated in an interview with the surveyor that she would expect a nurse to recheck vitals if a resident had a temperature or their oxygen saturation levels were low.  CMS Ex. 1 at 13.  Yet, even with Resident #2’s history of dysphagia and new onset of vomiting, there is no evidence that vital signs were checked again until another emesis and loose stool were reported between 3:50 PM and 4:10 PM, nearly two and a half hours after the initial abnormal readings and initiation of oxygen and Tylenol.  CMS Ex. 8 at 2, 3.

**Page 12**

Petitioner also asserts that “AMDA Guidelines include the use of respirations when making a decision on whether or not an acute or significant change of condition has occurred and not merely relying on oxygen saturations which can fluctuate with exertion or illness such as the norovirus.”  P. Pre-Hearing Brief at 12.  Clearly, all relevant findings, including respiration rate, should be considered in determining whether a significant or acute change of condition has occurred.  However, in citing only Resident #2’s normal respiration rate at 1:30 PM in its arguments, Petitioner ignores the other concerning abnormal findings identified at that time, as cited above.

Petitioner further alleges that it provided appropriate medical treatment and care and a timely RN assessment to Resident #2 and, prior to 3:50 PM to 4:10 PM, when the RN assessment was conducted, “R2 was not at risk or ‘likelihood’ that serious harm would occur in the near future.”  P. Pre-Hearing Brief at 18.  However, what Petitioner fails to acknowledge in this argument is that Resident #2 had a history of dysphagia following nontraumatic subarachnoid hemorrhage.  CMS Ex. 9 at 4, P. Ex. 4 at 1.  Swallowing precautions were included in her care plan, including swabbing after meals, checking for pocketing after meals, and remaining upright for 30 minutes after eating.  P. Ex. 4 at 3.  Petitioner acknowledges Resident #2 had a “high risk of aspiration.”  P. Pre-Hearing Brief at 7, citing P. Ex. 5.  Appropriately, when Resident #2 was returned to her room after the initial episode of vomiting at 12:30 PM, the LPN directed staff not to let her lie down because of the possibility of aspiration.  P. Ex. 1 at 2.  Her family was required to sign a waiver in order to give her solid food because of the risk of choking, aspiration, or aspiration pneumonia.  P. Ex. 6.  These complicating factors *did* increase the risk of serious harm associated with vomiting.  CMS Ex. 14 at 4.  In fact, the ER final diagnoses were pneumonitis due to inhalation of food and vomit, severe sepsis with septic shock, and acute respiratory failure with hypoxia, establishing that there *was* a significant risk of serious harm from a failure to perform a timely and thorough assessment by an RN after the initial vomiting episode and development of abnormal findings at 1:30 PM.  CMS Ex. 1 at 8.

After asserting that there was no basis for requiring an RN assessment prior to 3:50 PM, when Petitioner asserts that the acute or significant change of condition occurred, Petitioner argues that, in fact, an RN did conduct a visual assessment of Resident #2 at 3:15 PM, at which time she was resting comfortably and in no apparent respiratory distress.  P. Pre-Hearing Brief at 5; P. Ex. 1 at 4.  The only clinical record of this visit by the RN was a note in the Resident Progress Notes at 3:31 PM, indicating that an “Isolation [cart] [was] placed outside” the resident’s room and she had had one loose stool and one emesis so far that shift.  CMS Ex. 8 at 3.  However, there was no documentation in this clinical note of the resident’s respiratory status or any other observations.  Moreover, the descriptions of this RN visit by Petitioner’s witnesses do not support a conclusion that this was an “accurate and comprehensive” assessment of the

**Page 13**

resident, as required by the SOM guidelines.18
  Kathy Cavers, the Administrator and Chief Operating Officer, described that RN assessment as a “visual assessment” and an “eyes on” assessment.  P. Ex 1 at 2 and 5.  Angeline Cain, the DON, also described the RN assessment at 3:15 PM as “eyes on.”  P. Ex. 3 at 4.  When interviewed by the surveyor, the DON indicated the RN informed her she “did not go in the room.”  CMS Ex. 1 at 14.  However, as indicated in the AMDA Guidelines cited by Petitioner, when assessing a patient with signs or symptoms that may indicate an acute change of condition, caregiving staff should “*at a minimum*,” do the following:

Regardless of the patient’s cognitive level, ask the patient how he or she is feeling or how the symptoms developed.  Absence of a response should be documented.
	Take vital signs.
	Assess the patient’s overall condition, level of consciousness, and function.
	Seek information that might help a practitioner identify possible causes (both acute and chronic conditions) of the symptoms to help determine which body systems to evaluate further.P. Ex. 9 at 12 (emphasis added).

There is no indication that the 3:15 PM RN assessment included a temperature reading, O2 level measurement, blood pressure check, or any other measure of vital signs.  “Eyeballing” the resident is not a substitute for the thorough assessment required by the professional standards of care.

Petitioner appears to attempt to support the argument that there was no need for an assessment beyond that of an “eyes on” assessment by noting that Resident #2’s daughter, who was at her bedside at the time, “indicated her agreement with RN-R that there was no urgency at that moment, that her mom was resting comfortably and not showing any signs of respiratory distress.”  P. Pre-Hearing Brief at 13.

**Page 14**

Petitioner’s witnesses made similar statements.  P. Ex. 1 at 2-3.  The DON testified that “R2’s daughter, who is her 2nd health care agent, stated that her mother was ‘just fine’ and agreed that there was no urgent need for treatment at the moment.”  P. Ex. 3 at 3.  However, reliance on the statements from a person with no apparent medical background for a decision to delay a comprehensive and thorough assessment by an RN is misplaced.  According to the AMDA guidelines, “[o]bservation, description, and documentation of symptoms must be distinguished from interpretation” and even “[c]aregivers who make observations may not be qualified to interpret those observations.”  P. Ex. 9 at 12.  Statements from a family member regarding her observations would similarly raise concerns about the qualifications of that person to interpret those observations.  As such, the statements from Resident #2’s daughter do not lend support to the proposition that there was a comprehensive and thorough assessment by an RN at 3:15 PM, or that there was no need for such an assessment.

Similarly, Petitioner asserts that CMS did not acknowledge the “RN assessment of vitals at 1:30 p.m. and direction to check the oxygen saturation and subsequent concurrence to start oxygen at 2L[,] which does constitute assessment.”  P. Ex. 1 at 5.  Dyonne Wilhelm, RN, Petitioner’s manager of staff education, testified she considered the report of the LPN that Resident #2 had a low grade fever, a second emesis, and a pulse oxygen reading of 82%, and then ordered O2 at two liters and Tylenol.  P. Ex. 8 at 1-2.  Concededly, this could be considered some manner of “assessment.”  However, this is not found to be a complete assessment by an RN because she did not make her own observations, did not personally examine the resident, and, in fact, did not physically observe the resident.  Moreover, the Board has held that “monitoring and reacting to manifest symptoms are not the same as conducting a full assessment; only a full assessment can serve as the basis for a clear diagnostic determination.”  *Britthaven of Goldsboro,*DAB. No. 1960 at 9 (2005).

Petitioner argues that because Resident #2 apparently died of “Aspiration Pneumonitis due to underlying neurological disease,” the cause of her respiratory failure was her “own physiological impairments, not due to lack of intervention on the part of Lutheran Home.”  P. Ex. 3 at 4; P. Pre-Hearing Brief at 18-19.  Under this line of reasoning, only when a resident died of something *other* than his or her underlying disease would the facility be responsible.  Such an argument belies the purpose of a skilled nursing facility, in which presumably all residents have some sort of underlying disease or condition.  The Board has held that the quality of care requirement is “based on the premise that the facility has (or can contract for) the expertise to first assess what each resident’s needs are (in order to attain or maintain the resident’s highest practicable functional level) and then to plan for and provide care and services to meet the goal.”  *Spring Meadows,*DAB No. 1966 at 11 (2005).  This language clearly envisions identifying each resident’s underlying conditions and then ensuring that “each resident receive the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being,” *despite* their underlying disease.  42 C.F.R. § 483.25.

**Page 15**

In considering Resident #2’s underlying conditions, the record indicates she had a diagnosis of dysphagia following nontraumatic subarachnoid hemorrhage.  CMS Ex. 9 at 4; P. Ex. 4 at 1.  As discussed earlier, swallowing precautions were included in the care plan, including swabbing after meals, checking for pocketing after meals, and having Resident #2 remain upright for 30 minutes after eating.  P. Ex. 4 at 3.  Given the risk of choking, aspiration, or aspiration pneumonia, as detailed above, and the vomiting episodes on January 19, 2019, for Petitioner to allege that no intervention by the facility, such as an assessment by an RN when the resident first displayed a significant change in condition at 1:30 PM, would have made any difference is not consistent with the regulatory requirements of 42 C.F.R. § 483.25 or professional standards of practice.

CMS also found that Petitioner was not in substantial compliance with 42 C.F.R. § 483.25 because it failed to call Optum back to report changes in Resident #2’s condition.  As noted above, Optum was under contract with Petitioner to provide clinical support and physician referral services to its residents.  P. Pre-Hearing Brief at 7.  Optum records indicate that a call was made by a nurse from the facility at 1:31 PM, reporting that Resident #2 had two large emesis after lunch.  CMS Ex. 6.  The resident was reported to have had a large, regular BM in the morning.  Her abdomen was described as soft, and vital signs were reported, including blood pressure of 170/68, temperature of 98.2, and oxygen saturation level of 96%.  The facility nurse indicated to Optum that there were residents with a stomach virus in the building with similar symptoms.  Resident #2’s medical history was also reportedly provided in the call, which noted, among other diagnoses, functional quadriplegia, CVA [cerebral vascular accident] with residual right dominant hemiplegia and hemiparesis, vascular dementia with behaviors, anxiety, and depressive disorder.  According to the record of the call, the information was escalated to a nurse practitioner (NP), who would call back.  Optum’s “After-Hours On Call Process” document indicated that if a caller does not receive a call back within 15 minutes, he or she is advised to call again.  CMS Ex. 7.

There is no record of any attempt to update Optum with the abnormal vital signs of elevated temperature of 100.6, SpO2 at 82%, and congestion that were obtained at 1:30 PM, nor does Petitioner assert that Optum was provided with any updated abnormal physical findings.  CMS Ex. 1 at 12; CMS Ex. 8 at 3.  There is no record of any return call from Optum following the 1:31 PM call from the facility, nor does Petitioner assert that such a call was received by the facility.  CMS Ex. 1 at 13.  There is no record of an attempt by the facility to call Optum after 15 minutes had passed without a return call, nor does Petitioner assert that any such follow-up call was made.  Instead, it notes that “LPN-D reported [to Optum] that R2 had an emesis following lunch and provided Optum’s intake person with R2’s normal vital signs.”  P. Pre-Hearing Brief at 8.  This statement was corroborated by the LPN who made the call to Optum.  She indicated in an interview with the surveyor that she did not call Optum back with the second set of vitals because “she already had a call out and was trying to make R2 comfortable.”  CMS Ex. 1

**Page 16**

at 12.  The failure on the part of the facility to follow up when the phone call to Optum was not returned and the failure to report the abnormal vital signs obtained at 1:30 PM, only 15 minutes after the initial normal vital signs were reported, are not consistent with Optum’s procedural instructions or with professional standards of practice.

In an apparent attempt to counter this failure, Petitioner has submitted the declaration of Kim Jonas, an NP at Optum.  P. Ex. 7.  Ms. Jonas acknowledges that she was not involved in providing care in this case but stated that, if she would have been, the outcome would have been the same because she would have ordered labs and a chest x-ray, which take more than four hours, and would likely not have been administered prior to the resident’s transfer to the hospital.  P. Ex. 7 at 2.  This opinion was also cited in P. Ex. 3 at 5 and P. Ex. 1 at 4.  Because this case involves a summary judgment, I am not weighing the opinion of this, or any other, witness.  I do note, however, that speculation about what *might* have happened cannot overcome the actual facts showing what did and did not happen, as discussed herein.

In its final, and rather macabre, argument, Petitioner cites the declaration of Ms. Jonas for the proposition that because Resident #2 had a “signed and authorized DNR/DNI order,” her treatment orders would have been different if Resident #2’s daughter “had not insisted that her mother be sent to the ER.”  P. Pre-Hearing Brief at 19.  Ms. Jonas was more blunt.  She stated that “R2 had signed and expressed to staff her status to be DNR/DNI.  Under these circumstances and without R2’s daughter (health care agent) insisting to send R2 to the ER, I would have ordered Ativan and Morphine to be administered to R2 for comfort care, and worked with R2’s physician to allow R2 to remain and be treated at the facility as per her wishes.”  P. Ex. 7 at 2.  The apparent point of this argument is that, but for the interference from her family, Resident #2 would have died at the facility, rather than the hospital.

There are obvious problems with this argument.  First of all, it is a large leap to interpret a DNR/DNI order as a “do not treat” order.  One wonders about this interpretation in the case of a broken hip from a fall or injuries from a seizure.  Under the interpretation urged by Petitioner, such a resident would be provided only comfort care because there was a DNR/DNI order.  While this is a troubling and highly questionable interpretation, it is not necessary to determine whether it is a valid interpretation of a DNR/DNI order since I see no relevance to the overall argument.  Absent evidence that the health care agents were not duly authorized to act on Resident #2’s behalf, of which there is none in this record, it is inappropriate and insensitive to question their decision to request that their mother be sent to the ER for evaluation and treatment.  To speculate as to what treatment *would* (or would not) have been provided had the health care agents not elected to have their mother treated more aggressively is completely irrelevant to the issue before me, which is whether Resident #2 received treatment and care from the facility in accordance with professional standards of practice.  After reviewing the entire record in the light most favorable to Petitioner, I find she did not.  The facility did not provide Resident #2 with

**Page 17**

an accurate and comprehensive assessment by an RN at 1:30 PM, when she first displayed findings documenting a significant change of condition, and did not follow up on a phone call to Optum when that occurred.  As a result, the facility was not in substantial compliance with 42 C.F.R. § 483.25.

***B.  The penalty imposed is reasonable.***

I next consider whether the CMP is reasonable by applying 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.

In reaching a decision on the reasonableness of the CMP, 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 above 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).

CMS has imposed just one $17,350 per instance CMP, which is in the mid-to-high end of the penalty range for per instance penalties ($2,140-$21,393).  42 C.F.R. §§ 488.408(d)(iv), 488.438(a)(2); 45 C.F.R. § 102.3 (2018); 83 Fed. Reg. at 51,380.  Given the tragic outcome in this case, however, this amount is not unreasonable.

Petitioner has a history of noncompliance, including previous quality of care noncompliance, and a pattern of noncompliance in some areas.  CMS Ex. 4; 42 C.F.R. § 488.404(b).  There have been no previous immediate jeopardy findings, however.

Petitioner does not claim that its financial condition affects its ability to pay this amount.

Petitioner argues that it was in substantial compliance with F684 and “requests that F684 be rescinded, or in the alternative, the scope and severity of the Immediate Jeopardy be reduced to a “D” level citation, and that the subsequent CMP which arises from this action be reduced accordingly.”  P. Pre-Hearing Brief at 20.  However, the deficiency here was very serious, as the above discussion documents.  Resident #2 did not receive an accurate and comprehensive assessment by an RN at 1:30 PM, when she first displayed

**Page 18**

findings demonstrating an acute or significant change of condition, and Petitioner did not follow up with a phone call to Optum, with devastating results, for which the facility is culpable.

I, therefore, find reasonable the $17,350 per instance CMP.

IV.    Conclusion

Accepting as true all of Petitioner’s factual assertions, I find that the facility was not in substantial compliance with the Medicare requirements governing quality of care, 42 C.F.R. § 483.25.  The $17,350 per instance penalty imposed is reasonable.  I, therefore, grant CMS’s motion for summary judgment.


          /s/
        Mary M. Kunz

                      Administrative Law Judge
      1. Although CMS initially proposed additional remedies of discretionary denial of payment for new admissions and mandatory termination of Petitioner’s provider agreement, these remedies were rescinded and were not imposed because the facility achieved substantial compliance before the effective dates of those remedies.  CMS Exhibit (Ex.) 5 at 2. back to note 1
                      2. The case was originally assigned to Judge Thomas, but was later assigned to me on May 3, 2021. back to note 2
                      3. My findings of fact and conclusions of law are set forth, in italics and bold, in the discussion captions of this decision. back to note 3
                      4. While there are some discrepancies in the record with respect to the timing of certain events, for the purposes of summary judgment, I am relying on the times reported by Petitioner. back to note 4
                      5. The terms vomiting and emesis are used interchangeably in this record. back to note 5
                      6. There is no record of this assessment in the Resident Progress Notes or in any other facility record.  The only written reference is contained in an Optum call record documenting the call from Petitioner’s nurse.  CMS Ex. 6.  However, for the purposes of summary judgment, it is accepted as accurate. back to note 6
                      7. Although the Resident Progress Notes indicate that at 1:30 PM, the resident had two large emesis and two large loose stools, for the purposes of summary judgment, I am accepting the factual description provided by Petitioner. back to note 7
                      8. In its Pre-Hearing Brief, Petitioner alleges that the LPN was called to Resident #2’s room at 1:43 PM.  P. Pre-Hearing Brief at 8.  This would appear to be a recording error since the Resident Progress Notes recorded the incident at 1:30 PM, which is consistent with the declarations from Petitioner’s witnesses, who all note the approximate time of 1:30 PM.  CMS Ex. 8 at 3; P. Ex. 1 at 2; P. Ex. 3 at 2; P. Ex. 8 at 1.  It would be highly improbable that the progress note would be written before the incident occurred. back to note 8
                      9. There is no record of the administration of Tylenol in the Resident Progress Notes at that time.  CMS Ex. 8 at 3.  However, this is accepted as accurate for the purposes of summary judgment. back to note 9
                      10. While the reported blood pressure reading of 170/68 does not appear to be consistent with the numerous statements that the vital signs after the initial emesis were normal, for the purposes of summary judgment, I accept this as a normal finding.  P. Ex. 1 at 2; P. Ex. 3 at 2; P. Pre-Hearing Brief at 7; https://www.cdc.gov/bloodpressure/about.htm (last visited Aug. 4, 2021), citing The American College of Cardiology/American Heart Association Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults (2017 Guideline). back to note 10
                      11. The Resident Progress Notes for this entry do not contain any record of Resident #2’s temperature.  CMS Ex. 8 at 2-3.  However, for the purposes of summary judgment, this is accepted as accurate. back to note 11
                      12. Petitioner argues that an “acute” change of condition also triggers the need for an RN assessment and uses the terms “significant” and “acute” interchangeably.  P. Pre-Hearing Brief at 4. back to note 12
                      13. Petitioner, at one point, argues that “The [AMDA] guidelines do not stipulate a set timeframe for an RN assessment.  The Acute Change of Conditional [sic] (ACOC) guidance states that unless the patient’s condition is deteriorating rapidly or vital signs are markedly abnormal, or unstable, there is ample time to conduct a more detailed assessment of the problems before initiating treatment.”  P. Pre-Hearing Brief at 16 citing P. Ex. 9 (emphasis in brief).  It must initially be noted that there is no emphasis on “markedly” in the AMDA guidelines.  Moreover, the relevance of this citation is unclear in this case since the example in the guidelines following the quoted sentence indicates that “if a patient has a fever or a change in level of consciousness, nurses generally have 30 minutes or more to carry out a careful evaluation before deciding whether an emergency transfer is necessary.”  P. Ex. 9 at 17.  There is no indication in this case that there was insufficient time to conduct an accurate and comprehensive assessment. back to note 13
                      14. The SOM is CMS’s policy guidance to surveyors and its provisions are not binding.  Foxwood Springs Living Ctr., DAB No. 2294 at 8-9 (2009).  Although the SOM does not have the force and effect of law, the provisions of the Act and regulations interpreted clearly do have such force and effect.  Ind. Dep’t of Pub. Welfare v. Sullivan, 934 F.2d 853 (7th Cir. 1991); Nw. Tissue Ctr. v. Shalala, 1 F.3d 522 (7th Cir. 1993).  Thus, while the Secretary may not seek to enforce the provisions of the SOM, he may seek to enforce the provisions of the Act or regulations as interpreted by the SOM.
Appendix PP of the SOM (Revision 173, dated November 22, 2017) can be found at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107ap_pp_guidelines_ltcf.pdf
(last visited June 16, 2021). back to note 14
                      15. It must be stressed that Petitioner has not been cited for noncompliance with 42 C.F.R. §§ 483.20(b)(2)(ii) or 483.10(g)(14)(i)(B) and those regulatory sections are cited only for the guidance they provide in understanding the standards to be applied in this case. back to note 15
                      16. The LPN who recorded the vital signs reported to the surveyor that the time span between the first and second sets of vital signs was “probably good 15 minutes.”  CMS Ex. 1 at 12. back to note 16
                      17. In its brief, Petitioner states that “R2’s respirations remained at 20 until after the third emesis.”  P. Pre-Hearing Brief at 6 (emphasis added).  This statement is misleading since it implies that the respiration rate was checked regularly throughout the afternoon.  However, we have no idea whether the respiration rate “remained” at 20 since it was not checked between 1:30 PM, when it was reported to be 20, and 4:31 PM, when it was observed to be 50.  CMS Ex. 8 at 2, 3. back to note 17
                      18. Petitioner argues that the RN’s actions at 3:15 PM “constituted an assessment compliant with Wisconsin’s Standards of Practice for Registered Nurses.”  P. Pre-Hearing Brief at 5.  The Standards of Practice in Chapter N 6.03 under the Wisconsin Administrative Code define Assessment as the “systematic and continual collection and analysis of data about the health status of a patient culminating in the formulation of a nursing diagnosis.”  P. Ex. 2 at 1 (WIS. ADMIN. CODE  (N § 6.03(a)).  While it is difficult to see how a “visual” or “eyes on” assessment would meet this definition, for the purposes of summary judgment, I will accept that it may be considered an acceptable assessment in Wisconsin.  However, the relevant question here is whether it was a “accurate and comprehensive” assessment, which I find it was not, for the reasons discussed above. back to note 18 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