Toulon Rehabilitation & Health Care Center, DAB CR6497

DECISION

Toulon Rehabilitation & Care Center (Petitioner or facility) is a skilled nursing facility (SNF), located in Toulon, Illinois, that participates in the Medicare program.  Based on a complaint investigation and a COVID-19 Focused Infection Control survey completed on December 10, 2020, the Centers for Medicare & Medicaid Services (CMS) determined that the facility was not in substantial compliance with the program participation requirements set forth in 42 C.F.R. § 483.80(a)(1)(2)(4)(e)(f) and imposed a civil money penalty (CMP) of $6,810.00 per day from November 11, 2020 through December 8, 2020 and a CMP of $435.00 per day from December 9, 2020 through January 3, 2021, for a total CMP of $201,990.00¹.  CMS Exhibit (Ex.) 6. Petitioner here challenges those determinations and filed a Request for Hearing (RFH) on June 27, 2021.  For the reasons discussed below, I find that the facility was not in substantial compliance with the Medicare requirements set forth in 42 C.F.R. § 483.80(a)(1)(2), resulting in immediate jeopardy, and I affirm as reasonable the imposition of a $201,990.00 CMP.

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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 (Secretary) to promulgate regulations implementing the statutory provisions.  Act § 1819.  The Secretary’s regulations are found at 42 C.F.R. Part 483.  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.  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.  In this case, surveyors from the Illinois Department of Public Health (state agency) completed a complaint investigation and a COVID-19 Infection Control Survey on December 10, 2020.  CMS Ex. 6.  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.  Specifically, CMS found that the facility did not meet the federal requirements of 42 C.F.R. § 483.80(a)(1)(2)(4)(e)(f) (Tag F0880-Infection Prevention and Control, scope and severity level “L”)² and imposed the above CMP.  Petitioner’s timely RFH brings the matter before me for adjudication.  

On June 28, 2021, Administrative Law Judge Leslie Weyn issued a Standing Prehearing Order, setting forth prehearing procedures.³  Both parties filed their prehearing exchanges, including prehearing briefs (CMS PH Br. and P. PH Br.).  With its brief, CMS submitted 46 proposed exhibits, including the written direct testimony of one witness (CMS Exhibits (Exs.) 1-42).  With its brief, Petitioner submitted 10 proposed exhibits, including the written direct testimony of three proposed witnesses (P. Exs. 1-10).  CMS filed objections to P. Exs. 2, 3, 7, and 8 and requested to cross examine CMS’s proposed witnesses.  Petitioner filed a request to cross-examine the proposed witness identified by CMS.

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I held a prehearing conference (PHC) on November 29, 2023.  At the PHC, the parties agreed to amend the initial issues before me to whether Petitioner was in substantial compliance with the provisions of 42 C.F.R. § 483.80(a)(1)(2).  CMS initially objected to the admission of P. Exs. 2 and 8 and paragraphs 16 and 19 of P. Ex. 3 on the basis of relevance since those exhibits addressed a prior survey.  CMS PH Br. at 1-2.  It objected to the admission of P. Ex. 3 on the basis of lack of foundation, low evidentiary value, and because it reflected other staff members symptoms, knowledge, and beliefs.  CMS PH Br. at 3.  CMS objected to the admission of P. Ex. 7 on the basis that it was duplicative and partially incomplete.  Id.  Finally, it objected to page 3 of P. Ex. 8 on the basis of lack of foundation and relevance.  Id. at 2.  

At the PHC, CMS indicated that if it was granted leave to file rebuttal evidence it would waive its objection to P. Exs. 2, 8 and paragraphs 16 and 19 of P. Ex. 3.  Petitioner stated it had no objections to CMS’s motion to amend its exchange to add CMS Exs. 43-45, but requested the opportunity to cross examine the newly-added CMS proposed witness.  In response to CMS’s objections, Petitioner agreed withdraw P. Ex. 7 and page 3 of P. Ex. 8.  I overruled the objection to P. Ex. 3 because that document did contain personal observations of the declarant and statements about facility policy, which I found to be relevant and material.  See 42 C.F.R. § 498.60(b)(1).  CMS submitted an unopposed additional amended list of proposed exhibits with proposed CMS Ex. 46.  Accordingly, CMS Exs. 1-46 and P. Exs. 1-5, P. Ex. 8 except for page 3, and P. Exs. 9-10⁴ were admitted into the record.  CMS Exs. 35 and 43 and P. Exs. 3, 4, and 5 were provisionally admitted, and subsequently authenticated, at the hearing. 

A hearing was held on March 6-7, 2024.  Both parties cross-examined the witnesses of the other party.  The record was closed on June 4, 2024, following the submission of post-hearing briefs (CMS POH Br.; P. POH Br.). 

I.    Issues

The issues before me are:  

(1) whether the facility was in substantial compliance with 42 C.F.R. § 483.80(a)(1)(2);

(2) if the facility was not in substantial compliance, whether CMS’s determination of immediate jeopardy was clearly erroneous; and

(3) if the facility was not in substantial compliance, whether the CMP totaling $201,990.00 is reasonable? 

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II.   Discussion

1. The facility was not in substantial compliance with 42 C.F.R. § 483.80(a)(1)(2).⁵

Section 1819(d)(3) of the Act mandates that a skilled nursing facility:  

must (A) establish and maintain an infection control program designed 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 to protect the health and safety of residents, personnel, and the general public.  

Consistent with section 1819(d)(3), 42 C.F.R. § 483.80 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 evidence establishes that Petitioner did adopt an infection control program for COVID-19 that included rigorous screening requirements to assure that infected staff and other persons did not enter Petitioner’s premises.  CMS PHB; CMS POH Br.; CMS Exs. 13-14, 17, 20.  CMS does not challenge the specifics of that policy, nor does CMS allege that Petitioner’s policy failed to comport with accepted national standards for protection against COVID-19 infection.  CMS PHB; CMS POH Br.  CMS’s case centers around Petitioner’s failure to comply with federal guidance and failure to implement or effectuate its own infection control policies by not having dedicated staff to care for residents with confirmed COVID-19, allowing symptomatic staff members to work, not posting designated isolation precautions signage for residents on isolation precautions/units, not donning/doffing proper Personal Protective Equipment (PPE), not performing proper hand hygiene and glove changes, not allowing adequate contact times for sanitizing/disinfecting surfaces, and not disinfecting contaminated dietary equipment prior to transportation, all of which had the potential to affect the 76 residents residing in the facility.  CMS PHB; CMS POH Br.; CMS Ex. 1 at 3.  Each alleged violation is considered separately in this decision. 

Staffing Policy

Petitioner did have a written infection control policy for staffing.  That policy, set forth in a document entitled Toulon Rehabilitation and Healthcare Center COVID-19 Control

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Measures, Restrictions for Health Care Personnel (HCP), contained provisions that, among other provisions, required it to: 

• educate all employees that, if having symptoms of a respiratory infection, fever, sore throat, nausea, vomiting, diarrhea, extreme fatigue, muscle pain, or loss of taste and smell, not to report to work and contact their health care provider,
• initiate screening at the entryway of the facility for symptoms of COVID 19⁶ and/or fever,
• refer to the state agency COVID-19 Cases . . . and consult with the local health department for any employee with suspected or diagnosed COVID-19 on when they can return to work. 

CMS Ex. 14 at 2.  The facility had an additional infection control policy entitled Crisis Staffing for COVID-19, which included the provisions to:  

• Screen all employees at designated entryways of the facility for symptoms of COVID-19 and/or fever;
• Screen all employees prior to the beginning of the shift and the middle of the shift.  If any are identified as being ill, apply face mask and ask them to return home and contact their primary physician;
• In the case of suspected or diagnosed COVID-19 of any employee that is asymptomatic and working in a facility in a non-crisis staffing situation, the employee will not be allowed to return to work until the CDC guidelines for time based or test based have been met;
• In the case of suspected or diagnosed COVID-19 in of any employee that is asymptomatic and working in a facility in a crisis staffing situation, the employee will be allowed to work, but they will only be allowed to: 
  • provide direct care only for patients with confirmed COVID-19, preferably in a cohort setting;
  • provide direct care for patients with suspected COVID-19;
  • as a last resort, provide direct care for patients without suspect or confirmed COVID-19. 

CMS Ex. 20 at 1.  The Centers for Disease Control and Prevention (CDC) provided guidance entitled Strategies to Mitigate Healthcare Personnel Staffing Shortages, effective April 30, 2020.  CMS Ex. 37.  In that policy statement, the CDC indicated that healthcare facilities could develop plans to allow asymptomatic HCP who had

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unprotected exposure to COVID-19 but were not known to be infected to continue to work.  CMS Ex. 37 at 2.  However, that policy further required that HCP should still report temperature and absence of symptoms each day before starting work and if the HCP developed even mild symptoms consistent with COVID-19, they must cease patient care activities and notify their supervisor.  Id.  The CDC policy also contained crisis provisions, indicating that when there were no longer enough staff to provide safe patient care, facilities could allow HCP with confirmed COVID-19 who were well enough to work to provide direct care in the following order:  patients with confirmed COVID-19, preferably in a cohort setting, patients with suspected COVID-19, or, as a last resort, to patients without suspected or confirmed COVID-19.  Id. at 3.

Petitioner did have some infection control screening measures in place.  It required employees, vendors, and consultants to complete a COVID screening questionnaire upon entrance to the facility and provide the completed questionnaire to the nurse or Director of Nursing (DON).  CMS Ex. 21.  That form required the individual completing it to record their temperature and then indicate whether or not they were experiencing the symptoms of:  new or worsening cough, sore throat, chills or shaking with chills, muscle pain, headache (new/unusual) and not related to caffeine, hunger, history of migraines, cluster/tension headaches, new loss of taste or smell, new or worsening fatigue, runny nose or nasal drainage or GI upset (vomiting or diarrhea).  Id.

The facility initiated Crisis Staffing on November 22, 2020.  P. Ex. 3 at 2. 

CMS asserts that V22, a CNA, told the surveyor that she had a headache and “didn’t feel right” on November 18, 2020, but worked that day after she received a negative COVID-19 test.  CMS Ex. 1 at 14-15.  V22 reportedly indicated that, during her shift on November 21, 2020, she was notified of being positive for COVID-19 but finished her shift.  Id.  In her declaration, the surveyor stated that V22 failed to report her symptoms on the screening form when she first experienced them.  CMS Ex. 35 at 5.  CMS argues that V22 worked four days while positive with COVID-19 after experiencing headache, a symptom of COVID-19, on November 18, 2020.  CMS PH Br. at 9-10. 

In her declaration, V22 stated that on November 18, 2020, she “felt off,” was “feeling fatigued and worn out” and “may have had a headache but that would not be out of the ordinary for me.”  P. Ex. 5 at 1.  She indicated that she didn’t report any symptoms on the screening form on November 18, 2020, or at any time through November 21, 2020, because she did not have any of the symptoms asked about on the form and, if she did have a headache, it was not “new/unusual.”  Id. at 2.  She credibly testified at the hearing that she experienced ongoing headaches of varied frequency as a result of a previous brain surgery.  Transcript (Tr.) at 111.  She stated that when she learned of the positive results on November 21, 2020, she still had not experienced any symptoms of COVID-19

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and did not have a fever.  P. Ex. 5 at 1.  She stated she finished her shift on that date because she was not experiencing any symptoms, did not have a fever, and was working in the “Red Zone⁷.”  Id. at 2.  

A review of the screening from completed by V22 does not support the allegations that she failed to report symptoms of COVID-19 on November 18, 2020.  CMS Ex. 26.  None of the symptoms reported by V22 on November 18, 2020 were listed in the screening form⁸.  While she reported a headache, the form specifies a “new/unusual” headache.  CMS Ex. 26 at 1.  As noted above, V22 asserted in her declaration and in her testimony that the headache she experienced was not new or unusual.  P. Ex. 5 at 2; Tr. at 111.  Thus, there is no basis for concluding that V22 failed to report symptoms of COVID-19 on November 18, 2020, or at any time through November 21, 2020.  

However, because of the positive COVID-19 test received on November 21, 2020, V22 would be “diagnosed COVID-19” as of that date.  Under the facility’s COVID-19 staffing policy, if an employee is identified as being ill, a facemask was to be applied and they would be asked to return home and contact their primary physician.  CMS Ex. 20 at 1.  While “being ill” is not further defined, I would consider a positive COVID-19 test as “being ill.”  So, even if “asymptomatic,” under the facility’s COVID-19 staffing policy, an employee was not allowed to return to work until the CDC guidelines had been met.  CMS Ex. 20 at 1. 

Petitioner argued post hearing that V22 only worked with COVID residents and, because she was not symptomatic, completing a shift in a “Red Zone” was not a violation of facility policy.  P. POH Br. at 10.  However, the policy Petitioner cites was for crisis staffing situations.  CMS Ex. 20 at 1.  That same policy mandates that, absent crisis staffing, a COVID-19 positive but asymptomatic staff member “will not be allowed to work until the CDC guidelines for time based or test based have been met.”  Id.  Because Crisis Staffing was not initiated until November 22, 2020, the facility allowed V22 to

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work while positive for COVID-19 on November 21, 2020, thus failing to comply with its own infection prevention and control program, as required by 42 C.F.R. § 483.80. 

CMS asserts that V21 “worked five days while experiencing symptoms of COVID-19,” beginning November 11, 2020.  CMS PH Br. at 9.  While acknowledging that V21 tested negative for COVID-19 until November 18, 2020, CMS argued that “Toulon’s policy is absolute that employees suspected as having COVID-19 and symptomatic will not be allowed to work – there is no exception for negative tests.”  Id. at 11.  Petitioner asserts that V21 did not believe she had COVID-19 when she first started experiencing a runny nose and body aches and instead attributed those symptoms to a common cold.  P. PH Br. at 8.  It also disputes CMS’s interpretation of the policy cited in CMS Ex. 20 at 1, indicating that the policy statement only lists the symptoms of COVID-19 and does not indicate that if “someone has any symptoms, they are presumed to be positive for COVID-19.”  Id. at 9. 

In considering Petitioner’s actions with respect to V21 continuing to work while experiencing the symptoms of a runny nose and body aches, I must first note that none of the infection control policy statements relating to staffing during COVID-19 include any need for the affected individual to attribute the symptoms to COVID-19.  V21’s reported belief that she merely had a cold, while likely a sincerely held belief, is not relevant.  The question is quite simple; whether the staff person was experiencing any of the listed symptoms for COVID-19.  The record establishes that V21 was experiencing COVID-19 symptoms. 

Petitioner is correct that the facility’s staffing policy contained in CMS Ex. 20 does not indicate that anyone experiencing the specified symptoms is “presumed” positive for COVID-19.  However, the CDC policy does draw this conclusion.  In the policy statement entitled Criteria for Return to Work for Healthcare Personnel with SARS-CoV-2 Infection (Interim Guidance), effective August 10, 2020, the guidance refers to making decisions about return to work for HCP with confirmed SARS-CoV-2 “or who have suspected SARS-CoV-2 (e.g., developed symptoms of COVID-19) but were never tested for SARS-CoV-2.”  CMS Ex. 39 at 1 (emphasis added).  Thus, the CDC policy makes it clear that an individual is suspected of having COVID-19 if they have “developed symptoms of COVID-19.” 

There is no dispute that V21 reported symptoms of COVID-19.  While there remains a dispute as to when she first experienced symptoms, she did complete the screening form indicating the presence of muscle pain and runny nose beginning on November 13, 2020.  CMS Ex. 25 at 2.  There is also no dispute that she continued to work after experiencing symptoms of COVID-19.  An Hours Worked Simplified Report reflected that V21 worked on November 11, 12, 13, 16, 17, 18, 19, 20, and 22, 2020.  CMS Ex. 23.

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According to the surveyor, V21 reported during an interview that her symptoms of runny nose and chest tightness began on November 11, 2020, so she had a rapid test that day, which was negative.  CMS Ex. 1 at 16.  She reportedly told the surveyor that she was still having symptoms on November 12, 2020, so she texted the administrator and came in for a rapid test, which was again negative.  Id.  The surveyor reported that V21 indicated she was again tested on November 16, 2020, when she called into work saying she had symptoms but the test was again negative. Id. at 16-17.  On November 18, 2020, V21 reportedly told the surveyor that she was tested on November 18, 2020, because it was a routine testing day, and she was still having symptoms.  Id. at 17.  The surveyor indicated V21 stated she was off work after that date and was told by the local health department that she was assumed positive from November 11, 2020, since that was when her symptoms began.  Id. 

V21 submitted a declaration in which she stated she first had symptoms of body aches and a runny nose on November 13, 2020.  P. Ex. 4 at 1.  She reported that she texted the administrator on that date and received a rapid COVID test on that date, which was negative.  Id.  V21 reported that, because she believed she had a common cold, she worked for several more days with four negative COVID tests from November 9, 2020 through November 16, 2020.  P. Ex. 4 at 1.  On November 18, 2020, V21’s COVID test was positive.  CMS Ex. 25 at 4.  V21 stated in her declaration that after the positive COVID-19 test, she worked a CNA shift for 4.5 hours in the E wing “Red Zone.”  P. Ex. 4 at 2.  In her testimony, after reviewing testing records, V21 stated her symptoms began on November 11, 2020.  Tr. at 126. 

In determining the date on which V21 first experienced symptoms, I note that the surveyor reported she had no notes from this interview, but remembered the conversation clearly and drafted the Summary Statement of Deficiencies (SOD) from her notes, which indicated that V21 first experienced symptoms on November 11, 2020.  CMS Ex. 35 at 5.  The dates of the reported symptoms in V21’s COVID screening questionnaire are not consistent with the surveyor’s statements on this issue.  In the Employee, Vendor Consultant COVID Screening Questionnaire, V21 first reported the symptoms of runny nose and muscle pain on November 13, 2020.⁹  CMS Ex. 25 at 1-2.  However, the COVID-19 testing reports are consistent with the statements from the surveyor.  Those results show COVID testing on November 11, 2020, and November 12, 2020, the latter of which was reported to be because of COVID-19 symptoms.  CMS Ex. 25 at 3.  The testing dates are consistent with the statements reported by the surveyor that V21 had

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symptoms beginning on November 11, 2020, and had rapid testing on that day and the following day when her symptoms persisted.  CMS Ex. 1 at 16.  The testing reports are also consistent with the statements by the surveyor that V21 had testing on November 16, 2020, when she continued to have symptoms.  CMS Ex. 25 at 4; CMS Ex. 1 at 16.  Given V21’s testimony after viewing the testing results that she began experiencing symptoms of runny nose and body aches on November 11, 2020, I find that the weight of the record supports a finding that V21’s symptoms first began on November 11, 2020.  Tr. at 126. 

To address the undisputed fact that V21 did report symptoms of COVID-19 but continued to work through November 18, 2020, when she received the results of a positive COVID-19 test, Petitioner initially argues that: 

V21 did not believe she had COVID-19 when she first started experiencing a runny nose and body aches.  P. Ex. 4 at 1.  It was November in Illinois and she believed that she had a common cold.  Id.  The days that she continued to work, she did not have a fever and her symptoms were never more than a runny nose and some body aches.  

P. PH Br. at 8.  It further argues that the facility did not have significant reason to believe that V21 was COVID-19 positive because she had limited, if any, contact with residents who were positive, did not have a fever or cough, and did not lose her sense of taste or smell.  P. PH Br. At 9.  V1, the administrator further asserted that “a runny nose would not have been out of the ordinary, or an indication of COVID-19, in the winter and post-harvest season.  The lack of fever and multiple negative tests did not lead anyone to believe that she had COVID-19.”  P. Ex. 3 at 2.  V1 also indicated that V21 worked as the Alzheimer Coordinator, which did not require much, if any, resident interaction.  Id.  V21 similarly indicated she worked in an office with a door and did not participate in hands-on care of residents.  P. Ex. 4 at 2; Tr. at 118.  However, such arguments are not consistent with the facility’s own policy on staffing during the pandemic. 

Petitioner had a policy entitled COVID-19 Control Measures, which identified symptoms of fever, cough, shortness of breath, nasal congestion, runny nose, sore throat, diarrhea, vomiting, extreme fatigue, muscle pain, and loss of taste/smell.  CMS Ex. 14 at 1.  V21 specifically reported symptoms of a runny nose¹⁰, consistent with the COVID-19

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symptoms identified in the COVID-19 Control Measures.  Id.  Under the facility’s Crisis Staffing for COVID-19 policy referenced above, symptomatic HCP were to not report to work.  CMS Ex. 20 at 1.  Petitioner’s policies did not indicate that the screening and COVID-19 work restrictions only applied to staff providing direct care to residents.  To the contrary, they refer to “all employees,” “any employee” or “employees.”  CMS Ex. 20 at 1; CMS Ex. 14 at 2.  The facility was aware that V21 had reported symptoms consistent with COVID-19 as of November 11, 2020, but allowed her to continue to work through November 18, 2020.  The fact that V21 did not provide direct patient care during that time is irrelevant.  Even though she worked in an office with a door, she testified that she had to walk down the D halls and then down the C hall to get to her office (Tr. at 120) thereby potentially exposing the residents in isolation to COVID-19.  Moreover, V21 acknowledged that, on November 22, 2020, she worked one CNA shift for 4.5 hours, but reported that this work was performed on the E hall in the “Red Zone.”  P. Ex. 4 at 2.  While this was after Crisis Staffing had been implemented, the facility’s own policy stated that an employee who was diagnosed with COVID-19 and who was “asymptomatic” could provide direct care for patients with confirmed or suspected COVID-19 but a “symptomatic” employee would not be allowed to work until certain criteria were met.  CMS Ex. 20 at 1.  V21 was not “asymptomatic” and should not have been allowed to work under the facility’s own policy.  By permitting an employee who was reporting symptoms consistent with COVID-19 to continue to work, Petitioner violated its own policy and was not in compliance with the infection control provisions of 42 C.F.R. § 483.80. 

CMS alleged that V24 worked at least one shift while COVID-19 positive.¹¹  CMS PH Br. at 10.  V24 reportedly told the surveyor that she last worked on November 21, 2022 and went to work with a headache, which she did not report on the screening sheet.  CMS Ex. 1 at 15.  She allegedly reported that by the end of her shift, “my headache was obnoxious and I had a cough that had started.”  Id.  She reportedly called the Administrator that evening and told her she was symptomatic.  Id.

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Petitioner initially acknowledged that V24 did report “she had a headache and a cough that started during her shift on November 21, 2020.”  P. PH Br. at 11.  In its post hearing brief, Petitioner then argued that the Employee Infection Control Log shows that the first day she had symptoms was November 24, 2020.  P. POH Br. at 9.  However, that report does not indicate whether the “Onset Date” is the onset date of symptoms or the onset date of the COVID-19 diagnosis.  The dates reported by Surveyor Roos are consistent with testing reports.  V24 reportedly told the surveyor that by the end of her shift on November 21, 2020, her headache was obnoxious and a cough had started.  CMS Ex. 1 at 15.  She reportedly indicated she was really sick on Monday and was swabbed at the facility on Monday, which would have been November 23, 2020.  Id.  The record indicates that a SARS CoV 2 RNA (COVID 19) specimen was collected from V24 on November 23, 2020.  CMS Ex. 27 at 2.  This testing is consistent with the timeline of reported symptoms in CMS Ex. 1 at 15. 

The record established that V24 was symptomatic on November 21, 2020, but continued to care for residents on that date, in violation of facility policy requiring the facility to screen all employees prior to the beginning of the shift and every four hours during the shift and to ask ill employees to return home and contact their primary physician.  CMS Ex. 20 at 1.  The fact that V24 did not test positive for COVID-19 until November 26, 2020¹² is not relevant.  CMS Ex. 27 at 2.  As indicated above, the facility’s policy required it to screen employees during their shifts and ask ill employees to return home.  CMS Ex. 20 at 1.  Even assuming the facility was operating under Crisis Staffing at that time, which it was not, a symptomatic staff member would still not be allowed to work, even with COVID positive residents, under the facility policy discussed above.  As a result, Petitioner was noncompliant with 42 CFR § 483.80 because it failed to implement its infection control policies with regard to V24.  CMS Ex. 14 at 3. 

CMS alleges that V20¹³, a CNA, worked after testing positive for COVID on November 23, 2020.  CMS PH Br. at 8-9.  According to the surveyor’s notes, on November 28,

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2020, V20 told the surveyor that she tested positive for COVID “[t]his past Monday.”  CMS Ex. 33 at 5.  V20 stated she knew she has lost her sense of taste and smell but went to work anyway but did not report this on the screening form.  Id.  She reported she worked for a little while before she told anyone she was having symptoms and then was tested, with positive results.  Id. at 5-6.  V20 stated she was not sent home but instead worked the COVID positive hall on the B wing.  Id. at 6.  She stated that, as of November 28, 2020, she still did not have her sense of smell or taste back.  Id. 

Christina Smith, RN, Petitioner’s administrator at the time of the survey, stated V20’s only symptom was loss of taste and smell, and she was not aware of this when she reported to work, but she did alert a supervisor when she became aware of it and the remainder of her shift was in the COVID isolation wing.  P. Ex. 3 at 3.  Smith argues that: 

per the guidelines, an employee without a fever and/or gross respiratory symptoms would have been allowed to work if they chose to (see CMS Exhibit 20) . . . . An employee who only exhibited symptoms of loss of taste or smell would be allowed to return to work after a positive COVID-19 test under Crisis Staffing as long as they provided direct care for only COVID-19 positive residents. 

P. Ex. 3 at 2-3.  Petitioner asserts that there was no violation by allowing V20 to continue to work while asymptomatic and COVID positive.  P. PH Br. at 10. 

I would certainly agree that if V20 were “asymptomatic,” there would be no violation of facility policy since she did work in the Red or COVID positive zone on that date.  The problem here is that the record does not support a conclusion that V20 was “asymptomatic” on November 23, 2020, or on November 28, 2020, for that matter.  The facility Crisis Staffing Policy in CMS Ex. 20 does indicate that “Suspected or diagnosed COVID-19 of any employee that is asymptomatic and working in a facility in a crisis staffing situation” will be allowed to provide direct care for patients with confirmed or suspected COVID-19.  CMS Ex. 20 at 1 (emphasis added).  However, the policy statement goes on to indicate that any “symptomatic” employee with suspected or diagnosed COVID will not be allowed to work until they meet the criteria for return to work.  Id.

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Petitioner, through the administrator, apparently defines “asymptomatic” to include COVID-19 positive individuals exhibiting only loss of taste or smell or those without a fever or “gross” respiratory symptoms.  P. Ex. 3 at 2-3; Tr. at 145.  However, there is nothing in the facility policy cited above to support such an interpretation.  CMS Ex. 20.  Moreover, the “guidelines” referred to by the administrator setting forth this policy are not specified in her statement or referred to in the record.  Toulon’s COVID-19 Control Measures policy clearly lists symptoms of fever, cough, shortness of breath, nasal congestion, runny nose, sore throat, diarrhea/vomiting, extreme fatigue, muscle pain, and loss of taste/smell.¹⁴  CMS Ex. 14 at 1. 

V20 reported the symptoms of loss of taste and smell on November 23, 2020 and on November 28, 2020.¹⁵  CMS Ex. 33 at 5-6.  She tested positive for COVID on November 23, 2020.  CMS Ex. 24 at 3.  Because she was “symptomatic,” she should not have been allowed to work under the facility’s own policy.  By permitting an employee who was diagnosed with COVID-19 and who was also symptomatic to continue to work, Petitioner violated its own policy and was not in compliance with the provisions of 42 C.F.R. § 483.80, governing infection control. 

The Departmental Appeals Board (Board) has held that § 483.65¹⁶ requires a SNF to do more than merely adopt an infection control program as its internal policy; the regulation also requires the SNF to implement the program’s prescribed precautions.  Heritage House of Marshall Health & Rehab. Ctr., DAB No. 2566 at 12 (2014) (holding that

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§ 483.65 “can only reasonably be interpreted as requiring not just that an infection control policy exist, but also that the policy be followed.”); see also The Windsor House, DAB No. 1942 at 60 (2004) (stating that § 483.65 “makes clear that it is not enough simply to have an infection control program, but the facility must also follow the precautions established in that program.”); Park Manor Nursing Home, DAB No. 2005 at 60 (2005) (stating that § 483.65 “can reasonably be read as requiring the facility to implement an effective infection control program in [its] daily interaction with residents.”).  

Given the above, I find that the facility’s failure to implement its own policies by allowing symptomatic staff to work documents it was not in compliance with 42 C.F.R. § 483.80. 

CMS next asserts that Petitioner assigned staff to care for residents with COVID-19 and residents not diagnosed with COVID-19 during the same shift.  CMS PH Br. at 13.  Petitioner did have an infection control policy governing “COVID-19 Cohorting of Residents,” dated August 25, 2020.  CMS Ex. 17.  Among its provisions, this policy required the identification of space to care for residents with COVID-19 and that “HCP . . . . be assigned to work only within the dedicated area, when in use.”  Id.  In addition, on April 30, 2020, the CDC issued guidance to assist nursing homes with COVID-19 response.  Included in this guidance was the provision to “[a]ssign dedicated HCP to work only on the COVID-19 care unit” and stated that “[a]t a minimum this should include the primary nursing assistants (NAs) and nurses assigned to care for these residents.”  CMS Ex. 36 at 1. 

Toulon does not dispute the allegation that it did not have dedicated staff for residents who were COVID-19 positive.  According to the surveyor, the administrator indicated the third shift nurse covered C/D/E halls and she was “not able to dedicate staff to just COVID positive residents.”  CMS Ex. 33 at 8 and 13.  The facility asserted that “due to the dire staffing situation,” a nurse floated between the “Red Zone” and “Yellow Zone” halls during a shift.  P. PH Br. at 9.  It noted that “[t]he “Yellow Zone” was designated for residents who had prolonged exposure to COVID-19 or residents that had symptoms but were awaiting test results.  Id.  At that point, the “Yellow Zone” was seemingly presumed positive residents.  The nurse assigned would regularly change PPE and change PPE prior to entering different zones.  P. Ex. 3, at 3; P. PH Br. at 10.  At the hearing, the administrator testified that the nurse working both C and D halls would see the non-COVID positive residents first and then would work with the positive COVID residents at the end of the shift.  Tr. at 153. 

I have no reason to doubt the seriousness of the facility’s staffing problems during this time.  However, the fact remains that both the facility’s own policy and the CDC guidance required a separate space for residents with COVID-19 and a dedicated staff to

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provide their care.  Toulon did not comply with these provisions.  As a result, it was not in compliance with the provisions of 42 C.F.R. § 483.80 with regard to cohorting of residents. 

Hand Hygiene, PPE Removal, Disinfecting Standards, and Disinfecting Equipment

CMS asserts that Toulon staff failed to perform proper hand hygiene and PPE removal.  CMS PH Br. at 15.  It cites the observations of the surveyor that V13, a CNA, entered resident R5’s room in the Yellow zone room wearing a gown, N95 mask covered by a surgical mask, goggles, and gloves.  She was observed to exit that room wearing the same gown and gloves, enter and exit R6’s room, and then enter R7’s room wearing the same gown and gloves.  The surveyor indicated she observed V13 exiting R7’s room with no gloves but wearing the same gown and then entering R8’s room with the same gown and no gloves.  When in R8’s room, the surveyor stated she observed V13 picking up a water glass from the bedside table and assisting R8 with a drink of water, exiting the room without performing hand hygiene or changing her gown, and then walking to the central nurses’ station, touching her hair and face multiple times.  CMS Ex. 1 at 11-12; CMS Ex. 33 at 4.  V13 reportedly told the surveyor that she did not know what the specific isolations were for each resident, but she did know that she had to wear a new gown and gloves with each room she entered.  CMS Ex. 33 at 4.  According to the surveyor, V13 indicated she would wear an N95 and surgical mask at all times with goggles and would wear the same gown out in the hallways and would then change into another one as soon as she went into the resident’s room.  Id. At 4-5. 

Toulon did have an infection control policy governing hand hygiene and PPE usage.  That policy, entitled COVID-19 Control Measures Policy, specified “[a]ll staff is to perform Hand Hygiene when exiting a resident’s room, after direct contact with residents or potentially contaminated surfaces (high touch areas)[.]”  CMS Ex. 14 at 1.  The facility policy further required both Contact and Droplet Precautions, which included the directives to “[c]hange gloves and gowns after contact with a resident and perform hand hygiene” and “[r]emove PPE when leaving a residents (sic) room.”  Id.; see also CMS Ex. 14 at 2.  The facility’s Contact Precautions policy likewise specified that staff wear gloves when entering the room, and “[r]emove gloves before leaving the residents (sic) environment and wash hands immediately with an antimicrobial agent or a waterless antiseptic agent” and to “[r]emove the gown before leaving the resident’s environment.”  CMS Ex. 15 at 1. 

Toulon disputes CMS’s conclusions regarding this policy violation and argues that V13 did perform proper hand hygiene and changing of PPE while providing care to residents.  P. PH Br. at 12-13.  It cites the declaration of the administrator, who stated that a PPE Optimization Policy was in place at the time of the survey and V13 had been optimizing her gowns by keeping them inside the resident rooms and donning them prior to

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providing care.  P. Ex. 3 at 4.  The Administrator also indicated the layout of the resident rooms was such that, from the doorway of a resident’s room, a person would not be able to see into the entire bathroom and she did not observe the surveyor entering any resident rooms during the survey.  Id.

In her declaration, the surveyor stated that during her observation of V13, she would have been able to see if V13 put on an additional gown inside the rooms of R5, R6, R7, or R8 and would have been able to see if V13 had worn gloves or performed hand hygiene in R8’s room.  CMS Ex. 35 at 7.  In response to a question as to whether there was any point when she could not see V13, the surveyor testified there was not.  Tr. at 87. 

Taking Toulon’s allegation that it was operating under a PPE Optimization Policy under which V13 would keep her gowns in the resident rooms at face value, this still does not counter the surveyor’s observation that she did not observe V13 changing gowns once she was in a resident’s room, and she did not observe V13 perform hand sanitization when leaving R8’s room when not wearing gloves.  V1 asserts that from the doorway of a resident’s room, it would not be possible to see into the entire bathroom.  P. Ex. 3 at 4.  Presumably, V13 would immediately change her gown when she entered the room, and the surveyor would have been able to observe this.  However, if V13 had to go into the bathroom to change her gown, she would be walking through the resident’s room with a potentially contaminated gown from the hall before she changed into the gown she kept in the room and then would repeat this process when leaving.  Under either scenario, not changing the gown or changing the gown in the bathroom, the resident would be exposed to a potentially contaminated gown, in violation of the facility’s infection control policies.

Similarly, the same presumptions apply to hand sanitation procedures.  Toulon does not directly dispute that V13 was observed providing care to R8 without wearing gloves.  One would assume hand sanitizing liquid would be positioned by the door of a resident’s room.  If, in fact, V13 performed hand sanitation as she left R8’s room, the surveyor would have been able to observe her doing so.  If V13 went into the bathroom to sanitize her hands, she would then have to pass through the room of a potentially infected person after washing her hands, creating another pathway for transmitting COVID to another resident.  V13’s failure to fully comply with Toulon’s COVID-19 Control Measures Policy resulted in the facility not being in compliance with the provisions of 42 C.F.R. § 483.80, governing infection control.

CMS also asserts that Toulon staff were not in compliance with environmental infection control measures.  It cites the facility’s infection control policy requiring it to increase “frequency of cleaning and disinfecting of high touch areas, with an EPA, hospital grade disinfectant that is effective against COVID-19.”  CMS Ex. 14, at 4; CMS PH Br. at 16.

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V4, V5, and V8 reportedly told the surveyor that they didn’t know what the contact time for disinfecting was.  CMS Ex. 1 at 9; CMS Ex. 10.  V4 also indicated she did not know what was meant by high contact surfaces.  CMS Ex. 1 at 9.  Toulon has not presented any argument to dispute these allegations.  As a result, I am assuming that it is not contesting them, again demonstrating a failure to be in compliance with the provisions of 42 C.F.R. § 483.80, governing infection control.

CMS next alleges that Toulon staff failed to disinfect dietary equipment prior to transport, a violation of its infection control policies, citing CMS Exs. 18 and 19.  CMS PH Br. at 16.  Specifically, it notes Surveyor Roos reported observing a staff member push an enclosed food cart out of the E Hall into the D hallway at 10:05 am.  CMS Ex. 33 at 2.  Surveyor Roos then indicated that, at 10:15 am, V10 a dietary cook, wheeled the food cart up the D hall, past the nurses’ desk and into the dining room, stopping at the dishwasher.  Id.  V10 was then observed to sanitize the cart with bleach disinfecting spray.  Id. at 3.  According to CMS Ex. 1 at 11, V10 confirmed that the cart, which was from the COVID positive E Hall, was not disinfected before she took it though the facility.¹⁷  In her declaration, the surveyor stated it was her:

professional opinion that Toulon should have sanitized its dietary carts right after moving them from a red zone to a yellow zone and before moving them down the hallway, similar to how Toulon’s staff put on clean PPE immediately after they left the red zone, rather than just before exiting, as there is a risk that a cart sanitized in the red zone could become contaminated again before leaving the red zone. 

CMS Ex. 35 at 7. 

In the Request for Hearing, Toulon asserted that the “Dietary Cart was disinfected by COVID-19 Care Unit staff prior to being placed outside the double doors of the COVID-19 Care Unit.”  P. RFH at 2.  In its brief, the facility notes that the policies cited by CMS refer to sanitizing food trays for residents in isolation and do not address disinfecting dietary carts.  P. PH Br. at 12.

I find the record on this alleged policy violation to be unclear.  I agree with Petitioner that the policy cited by CMS does not specifically reference sanitizing dietary carts.  The only reference to dietary carts in the cited policy was as follows:  Dishes and/or food trays

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from any resident’s room which are visibly contaminated by blood or body fluids should be placed in a clear plastic bag before returning to the dietary department or placing on the food cart for return.  CMS Ex. 18 at 1.  CMS Ex. 19 contains a list of contact times for various disinfectant solutions.  There is nothing in either policy statement cited by CMS that specifically required disinfecting the food cart or specifying when that was to occur.  While the surveyor offered her “professional opinion” that the cart should have been disinfected before leaving the E hall, this opinion was unaccompanied by any authority on which that opinion was based and is given little weight. 

As noted earlier, Toulon asserted in the Request for Hearing that “Dietary Cart was disinfected by COVID-19 Care Unit staff prior to being placed outside the double doors of the COVID-19 Care Unit.”  P. RFH at 2.  If, in fact, there was evidence to establish that the dietary cart had been disinfected prior to leaving the E Hall, an argument as to whether it would be more appropriate to disinfect immediately before, rather than after, leaving the COVID unit may have been persuasive.  Disinfecting the cart while in the yellow zone outside the red zone would appear to create some risk of contaminating that zone.  However, it is not necessary to ponder that argument since I do not find any evidence of a clearly stated policy requiring sanitation of dietary carts and the timing and location of that sanitation in this record.  As a result, I find that the record does not support a finding that Toulon did not follow infection control policy and guidance with regard to the dietary carts. 

Signage in Isolation Units

There were two issues related to signage in isolation units raised in this matter.  CMS initially alleged that Toulon was not in compliance with 42 C.F.R. § 483.80 because of its failure to post signage with specific precautions for residents and zones with COVID-19. It asserts that “Toulon did not post signage as required by its Control Measures for COVID-19 policy”.  CMS PH Br. at 15.  It bases this position on statements by Surveyor Roos that: 

On 11/28/20 at 10:40 a.m., B Hall yellow zone:  exposed/symptomatic/COVID negative quarantine rooms.  B1-B4 and B12-B16 all had stop signs only on door.  No specific isolation precautions were posted.  A plastic curtain was hanging midway down the hallway starting at room B5 to separate the red zone from the yellow zone.  The other side of the curtain was the COVID positive residents.  The plastic curtain only contained a stop sign, no isolation precautions were posted nor designation that this was a COVID positive zone.

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CMS Ex. 1 at 11. 

Petitioner, through the administrator, argues that the two signs in P. Exs. 9 and 10 were the “signage that was present on the doorways leading into the “Red Zone” and the “Yellow Zone” at Toulon in November and December 2020.”  P. Ex. 3 at 4.  She further asserted that “[s]taff was trained about and aware of what the stop signs meant and the proper PPE required prior to entering the units where the stop signs were posted.”  Id.  Toulon further stated that it “believed, based on the survey that had occurred November 24, 2020, as well as CDC guidance, that the signage present was sufficient to put staff on notice of the PPE necessary for certain areas as well as precautions to take.”  P. PH Br. at 6.  It also argued that the facility policy stated that the signage was not required to be posted on the door of every impacted resident but instead on the doors leading into the unit.  P. PH Br. at 7; see also P. Ex. 3 at 3-4.  Post-hearing, Petitioner again argued that “signage was present on the doors leading into the COVID-19 units and the signage gave directions as to what precautions needed to be taken to enter certain areas.”  P. POH Br. at 5. 

Surveyor Boyer, the surveyor who conducted the survey at Toulon on November 24, 2020, submitted a declaration indicating that, during her observation of the E hall on November 20, 2020, there was a stop sign on the door to the E hall but the sign did not indicate the hall had COVID positive cases or identify contact or droplet precautions.  She did not recall seeing any signs on the plastic curtain further down the E hall and did not observe the signs in P. Exs. 9 or 10 on the entrance to the E hall or anywhere else in the portion of the E hall that she observed.  CMS Ex. 43 at 3.

At the hearing, Inspector Boyer testified that if she found a violation during the survey, she would have written it down.  Tr. at 29-30.  Surveyor Boyer further testified that, in her notes, she “put that the signage was in place.”  Tr. at 31.  In her testimony, she indicated she was unable to recall whether the signs in P. Exs. 9 and 10 were present on the day of the survey.  Tr. at 33.  Inspector Boyer testified that, based on the survey she conducted on November 20, 2020, she believed the facility was in compliance with 42 C.F.R. § 483.80 on that date.  Tr. at 28.

As with the evidence relating to the dietary cart sanitation issue, the record on the issue of whether Toulon posted proper infection control signage is confusing and inconsistent.  However, after reviewing the record, I find that it does not establish that Toulon posted the appropriate signage at the entrance to the COVID positive hall.

The hall observed by the Inspector Roos on November 28, 2020, was the B hall.  According to the floorplan contained in CMS Ex. 13, rooms 6 ,7, 8, 9, 10, and 11, at the end of that hallway, were in the red zone and the remainder of the rooms were in the yellow zone.  A plastic curtain was hung starting at room 5.  CMS Ex. 33 at 3.  CDC

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guidance for Responding to Coronavirus (COVID-19) in Nursing Homes, updated April 30, 2020, directed facilities to “[p]lace signage at the entrance to the COVID-19 care unit that instructs HCP they must wear eye protection and an N95 or higher-level respirator (or facemask if a respirator is not available) at all times while on the unit.”  CMS Ex. 36 at 2.  The question then becomes what signage, if any, was present “at the entrance to the COVID-19 care unit?” 

As noted above, the entrance to the COVID-19 care unit in the B hall was at the plastic curtain.  CMS Ex. 1 at 11.  Surveyor Roos stated she observed only a stop sign on the plastic curtain.  CMS Ex. 33 at 3.  V1 stated in her declaration that the documents marked as P. Exs. 9 and 10 were “present on the doorways leading into the Red Zone” and “Yellow Zone” at Toulon.  P. Ex. 3 at 4.  However, the entrance to the Red Zone or COVID positive care unit in the B hall was not a door but a plastic curtain hung by Room B5.  CMS Ex. 33 at 3; CMS Ex. 1 at 11.  As a result, V1’s statement is not consistent with the physical descriptions of the Red Zone’s entrance.

There was other contemporaneous evidence indicating the signs in P. Exs. 9 and 10 were not posted at the time of the inspection on November 28, 2020.  In a conversation with Surveyor Roos at 11:55 am on that date, V13 reportedly stated all of the residents she took care of were on quarantine and isolation, but specific isolation precautions were not posted on the doors or the COVID curtain on the hall where she worked, which she earlier identified as the B hall.  CMS Ex. 33 at 4.  As a result, she indicated she did not know the what the specific isolations were for each resident.  Id.  Accordingly, I have given greater weight to the statements from Surveyor Roos on the signage present at the time of the survey, which do not support Toulon’s allegation that the signs in P. Exs. 9 and 10 were posted “at the entrance to the COVID-19 care unit” as of November 28, 2020. 

Moreover, even assuming they were posted on the plastic curtain, the entrance to the COVID-19 care unit, the signs in P. Exs. 9 and 10 do not fully comport with the signage specified by the CDC, which included the requirement to wear an N95 or higher-level respirator.  CMS Ex. 36 at 2.  Neither sign in P. Exs. 9 and 10 contains this specific information. 

The record also does not support the conclusion that Toulon complied with its own policies covering COVID-19 Control Measures.  According to that policy, signage should be posted “on door” if a resident required contact precautions or droplet precautions.  CMS Ex. 14 at 2.  Petitioner correctly notes that “the policy does not specify which door” signage should be placed and interprets this language as requiring only signage on the doors leading into impacted hallways.  P. POH Br. at 4.

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Surveyor Roos noted at 10:40 am on November 28, 2020, there were stop signs on the doors of rooms B-1 through B-4 and B12 through B16, but no specific isolation precautions were posted.  CMS Ex. 33 at 3. This is consistent with the statements from V13 cited earlier, in which she indicated that specific isolation precautions were not posted on the doors and she did not know what the specific isolations were for each resident.  CMS Ex. 33 at 4. 

The administrator, in her declaration, indicated that, based on protocol and the information she received from the earlier surveyor, she believed posting the isolation precautions outside of the entrance of the zone would be sufficient and it was not necessary to post them on every resident door inside of the isolation zones.  P. Ex. 3 at 3-4.  However, such a position is illogical because the contact precautions and the droplet precautions contain different provisions.  If a resident was under droplet precautions, the resident was restricted to their room and HCP were required to wear a facemask/N95 and goggles or a face shield, which were not required under the droplet precautions.  CMS Ex. 14 at 1-2.  Given the differences, it would be necessary to post specific signs on each resident’s door to ensure that the appropriate precautions were being taken in each case. 

I do find the statements from Elizabeth Boyer, the surveyor who conducted the survey beginning on November 20, 2020, to be inconsistent and less than credible.  In her written declaration, she stated she observed that Toulon had a stop sign on the door to the E hall, but this did not indicate that the hall had COVID positive residents or list contact or droplet precautions and she did not recall seeing any signs on the plastic curtain.  CMS Ex. 43 at 3.  She also denied seeing P. Exs. 9 and 10 anywhere that she observed.  Id.  Yet, in her testimony at the hearing, she stated she would have indicated in her notes if the appropriate signage was not in place.  Tr. at 29-30.  It is difficult to reconcile these statements.  Either she observed deficiencies in the signage but failed to include them in her notes or there were no deficiencies at the time of the survey.¹⁸  Fortunately, it is not necessary to reconcile these apparent discrepancies.  Any possible deficiencies in the

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previous survey are not relevant, for the reasons noted above, and are not before me for resolution.

Based on the above evidence, I find that CMS has met its burden of proving a prima facie case of substantial noncompliance with 42 C.F.R. § 483.80 and Petitioner did not rebut that case by a preponderance of the evidence.  Therefore, I conclude that Petitioner was not in substantial compliance with 42 C.F.R. § 483.80. 

2.  CMS’s determination that Petitioner’s noncompliance with 42 C.F.R. § 483.80 posed immediate jeopardy to resident health and safety is not clearly erroneous. 

Immediate jeopardy exists if a facility's noncompliance has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident.  42 C.F.R. § 488.301.  The regulation does not require that a resident actually be harmed.  Lakeport Skilled Nursing Ctr., DAB No. 2435 at 8 (2012).  I must uphold CMS's determination as to the level of a facility's substantial noncompliance (which includes an immediate jeopardy finding) unless it is “clearly erroneous.”  42 C.F.R. § 498.60(c).  The “clearly erroneous” standard imposes on facilities a heavy burden to show no immediate jeopardy, and the DAB has sustained determinations of immediate jeopardy where CMS presented evidence “from which ‘[o]ne could reasonably conclude' that immediate jeopardy exists.”  See, e.g., Barbourville Nursing Home, DAB No. 1962 at 11 (2005) (quoting Florence Park Care Ctr., DAB No. 1931 at 27-28 (2004)).  In reviewing CMS's finding, I “must consider whether the totality of the allegations support the Agency's determination that [the SNF’s] noncompliance ‘has caused, or [was] likely to cause, serious injury, harm, impairment, or death to a resident.’”  Rosewood Care Ctr., 868 F.3d at 618 (7th Cir. 2017) (emphasis omitted). 

Petitioner has not directly presented an argument in opposition to the finding by CMS that its noncompliance resulted in immediate jeopardy.  In the Request for Hearing, it suggests that V1 should have been made aware before December 2, 2020, that immediate jeopardy was an issue.  P. RFH at 2-3.  It also raises an estoppel argument that the “finding of a violation from November 11-December 8, 2020, is inconsistent with the prior survey finding that Toulon was in substantial compliance as of November 24, 2020.”  P. PH Br. at 13.  It centers this argument around the inconsistent statements from the two surveyors about the appropriateness of the signage, as discussed above.¹⁹

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CMS contends that its immediate jeopardy finding is not clearly erroneous.  It asserts that Petitioner's noncompliance with 42 C.F.R. § 483.80 was likely to cause serious injury or harm to its residents “because COVID-19 spreads quickly and nursing home residents, as older individuals that often have health issues, are at high risk of serious illness or death from COVID-10.”  CMS PH Br. at 18; CMS Ex. 35 at 4.  The immediate jeopardy was determined to have begun on November 11, 2020, when V21 worked in direct patient care while displaying signs/symptoms of COVID-19.  CMS Ex. 1 at 21.  Immediate jeopardy continued when other symptomatic staff provided direct resident care and Toulon did not have dedicated staff to care for COVID-19 positive residents.  Id. 

Petitioner bears the burden of proof to show clear error in the immediate jeopardy determination.  CMS Br. at 28; see also 42 C.F.R. § 498.60(c)(2); Universal Health Care – King, DAB No. 2383 at 16 (2011), aff'd, Universal Healthcare/King v. Sebelius, 400 F. App'x 299 (4th Cir. 2012).  Given the evidence discussed extensively above, I find that Petitioner has not met that burden.  The record supports a finding that Petitioner’s noncompliance with 42 C.F.R. § 483.80 was likely to cause serious injury or harm to its residents.  Permitting symptomatic staff to work with vulnerable older residents exposed those residents to great risks of harm.  As a result, I find that CMS’s determination that Petitioner’s noncompliance with 42 C.F.R. § 483.80 posed immediate jeopardy to resident health and safety was not clearly erroneous. 

3. The CMP totaling $201,990.00 is reasonable under relevant statutory and regulatory factors for determining the amount of CMPs. 

CMS imposed on Petitioner a CMP of $6,810.00 per day from November 11, 2020 through December 8, 2020, and a CMP of $435.00 per day from December 9, 2020 through January 3, 2021, for a total of $201,990.00.  CMS Ex. 6 at 2. 

When determining whether a CMP amount is appropriate, 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) the factors specified in 42 C.F.R. § 488.404; and 4) the facility's degree of culpability, which includes neglect, indifference, or disregard for resident care, comfort, or safety.  See 42 U.S.C. §§ 1320a-7a(d)(2), 1395i-(h)(2)(B)(ii)(I).  The absence of culpability is not a mitigating factor.  The factors specified in 42 C.F.R. § 488.404 include:  the scope and severity of the deficiency, the relationship of the deficiency to other deficiencies resulting in noncompliance, and the facility’s prior history of noncompliance in general and in relation to the cited deficiencies.

Petitioner argues that “the inflated CMP failed to consider Toulon’s history of compliance, including the November 24, 2020 survey, as well as the immediate correction of the “Immediate Jeopardy” situation” and the penalty of $201,990.00 is “excessive and not reasonable.”  P. PH Br. at 14.

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In considering the regulatory factors, I would agree that the record does not reflect a concerning level of prior noncompliance on the part of Toulon.  I also note that CMS acknowledged the facility’s “relatively modest history of noncompliance.”  CMS PH Br. at 20-21.  However, with that observation, CMS pointed out that the CMP assessed “is in the lower end of the range for a per-day CMP for an immediate jeopardy finding ($6,810 per day as compared to range of $6,808 to $22,320 per day) and for a Category 2 finding ($435 as compared to range of $112 to $6,695).  CMS Exs. 6 & 7, at 2; see 85 Fed. Reg. 2869, at 2879-2880 (Jan. 17, 2020); CMS Ex. 4.”  Id. at 21.  I concur with the analysis of CMS.  While the history of noncompliance on the part of Toulon is not significant, the CMP assessed reflects that degree of noncompliance with the use of the lower range of possible penalties. 

I find the scope and severity of the deficiencies to be high.  As discussed above, the number of symptomatic staff providing direct resident care and the failure to provide dedicated staff to COVID-19 residents reflects a systemwide failure with potential deadly consequences for facility residents. 

Toulon has not provided any evidence relating to its financial condition. 

Given the evidence relating to the above regulatory factors, I conclude that the total CMP of $201,990.00 is appropriate. 

IV.   Conclusion

I uphold CMS’s determination that Petitioner was not in substantial compliance with 42 C.F.R. § 483.80(a)(1)(2), the determination of immediate jeopardy was not clearly erroneous, and the total CMP of $201,990.00 was reasonable.

Endnotes

¹  Additional remedies of discretionary denial of payment for new admissions and mandatory termination were proposed but never effectuated.  CMS Ex. 6 at 2.  In the Request for Hearing (RH), petitioner indicated it was contesting all remedies, but it subsequently withdrew the RH on the remedies that were not effectuated.  Petitioner’s Prehearing Brief at 2-3.  As a result, they are not addressed in this decision.

²  Scope and severity levels are used by CMS and state survey agencies when selecting remedies.  The scope and severity level is designated by letters A through L.  CMS Pub. 100-7, State Operations Manual (SOM), chap. 7, § 7400.3.1 (Factors That Must be Considered When Selecting Remedies); “Assessment Factors Used to Determine the Seriousness of Deficiencies Matrix” (table) (Rev. 63, effective November 16, 2018); see also 42 C.F.R. § 488.408.  A scope and severity level of “L” indicates widespread substantial noncompliance that causes immediate jeopardy.

³  This case was reassigned to me on September 28, 2023.

⁴  At the hearing, Petitioner noted that it did not submit a P. Ex. 6.

⁵  My findings of fact and conclusions of law are set forth in bold and italic text in the discussion section of this decision.

⁶  Symptoms of COVID-19 were defined earlier in that document as fever, cough, shortness of breath, nasal congestion, runny nose, sore throat, diarrhea/vomiting, extreme fatigue, muscle pain, and loss of taste/smell.  CMS Ex. 14 at 1.

⁷  A Red Zone was characterized by the facility as an area for residents that had confirmed cases of COVID-19.  Tr. at 137.

⁸  V22 did initially report the symptoms of fatigue and feeling worn out on November 18, 2020, to the surveyor, but those symptoms were not included on the form she completed.  While some employees completed forms that included “new or worsening fatigue” as a symptom of COVID-19, other employees, such as V22, completed forms that did not include that symptom.  Compare CMS Exs. 24 at 1 and CMS Ex. 26 at 1.  While an argument could be made that the facility did not ensure that employees were able to completely report all associated symptoms, this was not a deficiency cited by CMS.

⁹  The surveyor raised concerns about V21 leaving certain symptom boxes blank on this form.  CMS Ex. 35 at 5.  However, in her declaration and in her testimony, V21 credibly testified that this was an oversight and unintentional.  P. Ex. 4 at 2, Tr. at 130.  I have no reason to believe there was any intent to deceive on the part of V21.

¹⁰  V21 disputed the characterization of her reported symptoms of body aches versus muscle pain and disagreed that body aches were a symptom of COVID-19.  Tr. at 126-127.  However, it is not necessary to resolve this question since runny nose is clearly identified as a COVID-19 symptom. 

¹¹  V24 was listed on staffing sheets for November 21, 22, and 23, 2020.  CMS Ex. 22 at 12-14.  Petitioner asserts that there is no indication that those sheets were correct and those employees actually worked on those dates.  P. PH Br. at 10.  It is not necessary to resolve the question of whether V24 worked after November 21, 2022, since the record establishes that she did work while exhibiting symptoms of COVID-19 on that date, as discussed below.

¹²  The positive test report indicates the specimen was collected on November 23, 2020, and reported on November 26, 2023.  CMS Ex. 27 at 2.

¹³  There is some confusion in the record with respect to records of COVID testing and symptom reporting for V20.  An Identity Key for the facility indicated there was an LPN named Lisa Ramsey, identified as V6, and a CNA named Alisa Ramsey, identified as V20.  CMS Ex. 9.  It appears that page 1 of CMS Ex. 24 contains the symptom report of Lisa Ramsey, V6, but the remainder of the exhibit contains the testing results of Alisa Ramsey, V20.  CMS Ex. 24 at 2-5.  Although not specifically noted in the SOD, it appears that V6 also reported symptoms of new or worsening cough and GI upset on November 24, 2020 and sore throat and new loss of taste and smell on November 25, 2020 but continued to work on those days.  CMS Ex. 24 at 1; CMS Ex. 22 at 16-17.

¹⁴  The Crisis Staffing policy for Toulon does initially indicate that it should educate all employees if having symptoms of “a respiratory infection, fever, sore throat, nausea, vomiting, diarrhea, or extreme fatigue” not to report to work.  CMS Ex. 45 at 25; CMS Ex. 20 at 1.  The policy clearly identifies symptoms that would preclude coming into work.  The policy further requires screening employees at the entryway “for symptoms of COVID -19” and/or fever, a more extensive list.  Nowhere is there an indication that certain symptoms may be ignored in assessing fitness for work in the facility.

¹⁵  Petitioner argues post-hearing that there was no documentation as to V20’s symptoms and the statements that she had symptoms were hearsay.  P. POH Br. at 9.  However, the Antigen Testing and Results report for V20 dated November 23, 2020, indicated that the reason for testing on that date was “COVID symptoms.”  CMS Ex. 24 at 3.  Moreover, V1, the administrator, indicated in her declaration that V20’s “only symptom was loss of teste and smell.  She was not aware of this when she reported to work but did alert a supervisor when she became aware of it.”  P. Ex. 3 at 3.  Thus, the evidence does establish that V20 did experience and report symptoms of COVID-19.

¹⁶  42 C.F.R. § 483.65 was redesignated as 42 C.F.R. § 483.80. 81 Fed. Reg. 68,688 (Oct. 4, 2016).

¹⁷  I would note that the surveyor’s notes in CMS Ex. 33 at 3 do not attribute the statement about the sanitation of the cart not occurring until it was returned to the dining room to V10.  Instead, it is a blanket statement that “Cart is not sanitized before leaving the wing” so it is not clear whether this was a statement from V10 or a conclusion by the surveyor.

¹⁸  The inconsistencies in the statements of the first surveyor do raise questions about the adequacy of that survey.  However, the issues before me involve only the deficiencies cited in the survey completed on December 10, 2020.  Moreover, even if the survey beginning on November 20, 2020 was inadequate, inadequate survey performance does not invalidate adequately-documented deficiencies.  42 C.F.R. § 488.318(b); see also 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.”).  

¹⁹  The determination by CMS of immediate jeopardy was initially premised on a symptomatic staff member providing resident care beginning on November 11, 2020, and a failure to provide dedicated staff.  CMS Ex. 1 at 3.  Any subsequent alleged inconsistent information provided about signage did not contribute to this initial determination of immediate jeopardy so Petitioner’s estoppel argument is not relevant to this analysis.