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                              Casey Healthcare Center, DAB CR6345 (2023)
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Casey Healthcare Center, DAB CR6345 (2023)








  
  
    

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





Casey Healthcare Center,
(CCN: 146117),
Petitioner,

v.

Centers for Medicare & Medicaid Services.
Docket No. C-21-1029Decision No. CR6345August 29, 2023

        
              
    

      DECISION

Petitioner, Casey Healthcare Center, is a long-term-care facility, located in Casey, Illinois, that participates in the Medicare program.  Within weeks after a staff member tested positive for the disease, virtually every one of its residents contracted COVID-19, and about one quarter of those who contracted the disease died.  I now consider the facility’s response to the COVID-19 outbreak and its compliance with infection control and related requirements.

Following a survey, completed on January 21, 2021, the Centers for Medicare & Medicaid Services (CMS) determined that the facility was not in substantial compliance with Medicare program requirements governing infection control and that its deficiencies posed immediate jeopardy to resident health and safety.  CMS imposed civil money penalties (CMPs) of $11,395 per day for nine days of immediate jeopardy, and $435 per day for 16 days of substantial noncompliance that did not pose immediate jeopardy.

Petitioner appealed, and CMS has moved for summary judgment, which Petitioner opposes.

Page 2

For the reasons set forth below, I grant CMS’s motion.  The undisputed evidence establishes that, from January 11 through February 4, 2021, the facility was not in substantial compliance with Medicare program requirements governing infection control; that, from January 11 through 19, 2021, its deficiencies posed immediate jeopardy to resident health and safety; and that the penalties imposed are reasonable.

I.    Background

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

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

Section 1135 of the Act authorizes the Secretary to waive or modify certain statutory and regulatory requirements under the Medicare program in response to an emergency or disaster.  Responding to the public health crisis created by the COVID-19 pandemic, the Secretary, on March 13, 2020, modified survey and certification requirements for long-term-care facilities.  *See* https://www.phe.gov/emergency/news/healthactions/section1135/Pages/covid19-13March20.aspx.  CMS then prioritized infection control surveys and created a survey tool that focuses on infection control.  Specifically, the survey tool focuses on critical elements associated with the transmission of the highly infectious – and sometimes deadly – disease, COVID-19.  *See* CMS Ex. 28.

Facilities were expected to comply with the CMS guidance in effect at the time of the survey.

**The survey**.  On January 21, 2021, surveyors from the Illinois Department of Public Health (state agency) completed a COVID-19 Focused Infection Control Survey of the facility.  Based on the survey findings, CMS determined that the facility was not in substantial compliance with:

Page 3

42 C.F.R. § 483.80(a)(1)(2)(4)(e)(f) (Tag F880) (infection control – prevention and control program), cited at scope and severity level L (widespread substantial noncompliance that poses immediate jeopardy to resident health and safety); and
	42 C.F.R. § 483.80(h)(1)-(6) (Tag F886) (infection control – COVID-19 testing), cited at scope and severity level F (widespread substantial noncompliance that causes no actual harm with the potential for causing more than minimal harm).CMS Exs. 4, 5; CMS Ex. 30 at 1 (McFarlin Decl. ¶ 2); CMS Ex. 32 (Gulick Decl. ¶ 2).

Surveyors returned to the facility and completed a revisit survey on February 18, 2021.  Based on those survey findings, CMS determined that the facility returned to substantial compliance on February 5, 2021.  CMS Ex. 3; CMS Ex. 4 at 2; CMS Ex. 24.

Based on the deficiencies cited, CMS has imposed against the facility penalties of $11,395 per day for nine days of substantial noncompliance that posed immediate jeopardy to resident health and safety (January 11 through 19, 2021), and $435 per day for 16 days of substantial noncompliance that did not pose immediate jeopardy (January 20 through February 4, 2021).  (Total:  $102,555 + $6,960 = $109,515).  CMS Ex. 4 at 2.

Petitioner appealed.

CMS has submitted a motion for summary judgment and pre-hearing brief (CMS Br.) with 32 exhibits (CMS Exs. 1-32).  Petitioner has submitted a response and pre-hearing brief (P. Br.) with seven exhibits (P. Exs. 1-7).

II.    Issues

I consider first whether summary judgment is appropriate.

On the merits, the issues are:

From January 11 through February 4, 2021, was the facility in substantial compliance with Medicare program requirements governing infection control;
	If, from January 11 through 19, 2021, the facility was not in substantial compliance with Medicare program requirements, did its deficiencies then pose immediate jeopardy to resident health and safety; and
	• If the facility was not in substantial compliance with program requirements, are the penalties imposed – $11,395 per day for nine days of immediate jeopardy andPage 4

$435 per day for 16 days of substantial noncompliance that did not pose immediate jeopardy – reasonable?

III.    Discussion

**Summary judgment**.  Summary judgment is appropriate if a case presents no genuine issue of material fact, and the moving party is entitled to judgment as a matter of law.  *Bartley Healthcare Nursing & Rehab.*, DAB No. 2539 at 3 (2013) (citing*Celotex Corp. v. Catrett*, 477 U.S. 317, 322-25 (1986)); *Ill. Knights Templar Home*, DAB No. 2274 at 3-4 (2009), and cases cited therein.

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. U.S. Dep’t of Health & Human Servs.*,388 F.3d 168, 173 (6th Cir. 2004) (quoting *Celotex*, 477 U.S. at 322).  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., Ltd., v. Zenith Radio Corp.*,475 U.S. 574, 586 n.11, 587 (1986); *see also Vandalia Park*,DAB No. 1939 (2004); *Lebanon Nursing & Rehab. Ctr.*, DAB No. 1918 (2004).  The non-moving party may not simply rely on denials but must furnish admissible evidence of a dispute concerning a material fact.  *Ill. Knights Templar*, DAB No. 2274 at 4; *Livingston Care Ctr.*, DAB No. 1871 at 5 (2003).  In doing so, the non-moving party must show more than “some metaphysical doubt as to the material facts.”  *W. Tex. LTC Partners, Inc.*, DAB No. 2652 at 6 (2015), *aff’d*,*W. Tex. LTC Partners, Inc. v. U.S. Dep’t of Health & Human Servs.*, 843 F.3d 1043 (5th Cir. 2016); *1866ICPayday.com, L.L.C.*, DAB No. 2289 at 3 (2009) (quoting *Matsushita*, 475 U.S. at 587).

In examining the evidence for purposes of determining whether summary judgment is appropriate, I must draw all reasonable inferences in the light most favorable to the non-moving party.  *Brightview Care Ctr.*, DAB No. 2132 at 2, 9 (2007); *Livingston Care Ctr.*, 388 F.3d at 172; *Guardian Health Care Ctr.*,DAB No. 1943 at 8 (2004); *see also* *Brightview*, DAB No. 2132 at 10 (entry of summary judgment upheld where inferences and views of non-moving party are not reasonable).  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*.  *W. Tex. LTC Partners, Inc.*, DAB No. 2652 at 6-7; *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.”); *see Green Valley Healthcare & Rehab. Ctr.*, DAB No. 2947 at 8 (2019), (*quoting Johnson v. Perez*, 823 F.3d 701, 705 (D.C. Cir. 2016) (noting that a genuine factual dispute does not exist “when a putatively disputed body of

Page 5

evidentiary material could not, even assuming a sympathetic factfinder, reasonably support a finding crucial to the nonmoving party’s legal position.”)).

**Summary judgment applied to administrative review in Medicare cases**.  It is well-established that an administrative law judge is empowered to decide a case on summary judgment, without an evidentiary hearing.  *Shah v. Azar*, 920 F.3d 987, 996 (5th Cir. 2019) (citing *Cedar Lake Nursing Home v. U.S. Dep’t of Health & Human Servs.*, 619 F.3d 453, 457 (5th Cir. 2010)); *see Fal-Meridian, Inc. v. U.S. Dep’t of Health & Human Servs.*, 604 F.3d 445, 449 (7th Cir. 2010) (“All it means for a decision to be based on a grant of summary judgment is that there are *no issues that would benefit from being resolved in an evidentiary hearing*.”) (emphasis added); *Jewish Home of Eastern Pennsylvania*, DAB No. 2451 at 4 (2012); *Vandalia Park*, DAB No. 1939 at 5-6 (2004), citing *Crestview Parke Center v. Thompson*, 373 F.3d 743, 750 (6th Cir. 2004).  As the Departmental Appeals Board reminded us in *Jewish Home*, the requirement for affording an oral hearing is not contravened by summary judgment if there are no genuine issues of material fact.  *Jewish Home*, DAB No. 2451 at 4 (quoting *Vandalia Park*, DAB No. 1939 at 5-6).1

***Summary judgment is appropriate here because the undisputed evidence establishes that the facility did not follow its own policies nor the CDC (Center for Disease Control and Prevention) guidelines for screening and testing residents and staff; and the facility’s symptomatic and infected staff continued to work.  These failures put the facility out of substantial compliance with 42 C.F.R. § 483.80(a) and (h).2*****A.  Program requirements:  Section 1819(d)(3)** of the Social Security Act provides 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

Page 6

reside and to help prevent the development and transmission of disease and infection,” and (B) be designed, constructed, equipped, and maintained in a manner that protects the health and safety of residents, personnel, and the general public.

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

The program must include:

1)   a system for preventing, identifying, reporting, investigating, and controlling infections and communicable diseases for all residents, staff, volunteers, visitors, and other individuals providing services under a contractual arrangement based upon the facility assessment conducted according to § 483.70(e) and following accepted national standards;3

2)  written standards, policies, and procedures for the program, which must include:

i)   a system of surveillance designed to identify possible communicable diseases or infections before they can spread to other persons in the facility;

ii)   when and to whom possible incidents of communicable disease or other infections should be reported;

iii)   standard and transmission-based precautions to be followed to prevent the spread of infections;

iv)   when and how isolation should be used for a resident, including:

A)   the type and duration of the isolation, depending upon the infectious agent or organism involved; and

B)   a requirement that the isolation should be the least restrictive possible for the resident under the circumstances.

Page 7

v)   the circumstances under which the facility must prohibit employees with a communicable disease or infected skin lesions from direct contact with residents or their food, if direct contact will transmit the disease; and

vi)   the hand hygiene procedures to be followed by staff involved in direct resident contact.

*****

4)   a system for recording incidents identified under the infection prevention and control program and the corrective actions to be taken by the facility.

Personnel must handle, store, process, and transport linens so as to prevent the spread of infection.

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

The infection-control regulation thus requires that the facility have written infection-control policies in place, and that it *implement* those policies.  If it does not, it violates section 483.80(a).4  *Golden Living Ctr. – Superior*, DAB No. 2768 at 7 (2017); *Heritage House of Marshall Health & Rehabilitation Ctr*., DAB No. 2566 at 12 (2014).  *See Rockcastle Health and Rehab. Ctr.*, DAB No. 2991 at 19 (2018) (ruling that, absent contrary evidence, it is reasonable to presume that the facility’s policies reflect professional standards); *Bivins Memorial Nursing Home*, DAB No. 2771 at 9 (2017); *Hanover Hill Health Care Ctr.*, DAB No. 2507 at 6 (2013); *Life Care Ctr. at Bardstown*, DAB No. 2233 at 21-22 (2009) (finding that a facility’s failing to comply with its own policies can constitute a deficiency).

**Section 483.80(h)** requires the facility to test residents and facility staff (including contractors and volunteers) for COVID-19.  At a minimum, the facility must:

1)   conduct testing based on parameters set forth by the Secretary, including, but not limited to:  i) testing frequency; ii) identifying any individual diagnosed with COVID-19; iii) identifying any individual with symptoms consistent with COVID-19 or with known or suspected exposure to COVID-19; iv) criteria for testing of asymptomatic individuals, such as the positivity rate of COVID-19 in a

Page 8

county; v) the response time for test results; and vi) other factors, specified by the Secretary, that help identify and prevent the transmission of COVID-19.

2)   Conduct testing in a manner consistent with current standards of practice.

3)   For each instance of testing:  i) document that staff testing was completed and document the results of each staff test; and ii) document in the resident records that testing was offered, completed, and the results of each test.

*4)   Upon identifying an individual with symptoms consistent with COVID-19, or who tests positive for COVID-19, act to prevent its transmission.*

5)   Have procedures for addressing residents and staff who refuse testing or cannot be tested.

6)   When necessary, such as in emergencies due to testing supply shortages, contact state and local health departments for assistance.

**B.  Facility policies:  infection control – surveillance and monitoring**.  The facility had in place an infection control policy for routine surveillance and monitoring “to determine if compliance with work practices and care of protective clothing and equipment is maintained.”  CMS Ex. 11 at 1.

**Facility policy:  COVID-19 control measures**.  A related policy, last revised on October 1, 2020, was specifically designed to prevent transmission of the COVID-19 virus and to control outbreaks.

The policy lists the symptoms of COVID-19:  fever, *cough*, shortness of breath, *nasal congestion*, *runny nose*, sore throat, diarrhea/vomiting, extreme fatigue, muscle pain, and loss of taste/smell.  CMS Ex. 11 at 3.

**Facility policy:  restrictions for health care personnel**.  Among other requirements, the policy directs the facility to:

educate all employees *not to report to work* if they are having *symptoms of a respiratory infection*, fever, sore throat, nausea, vomiting, diarrhea, extreme fatigue, muscle pain, or loss of taste and or smell;
	*initiate screening* at the facility’s entrance for symptoms of COVID-19 and/or fever;
	educate employees to notify the administrator, the director of nursing (DON), or infection control practitioner (ICP) if they have been exposed to someone withPage 9

COVID-19 or have recently traveled to an area with COVID-19 transmission; the DON or ICP must notify the local health department for guidance;

refer to the state agency’s “COVID-19 Cases and Contacts from Isolation and Quarantine” and *consult the local health department about any employee with suspected or diagnosed COVID-19 as to when the employee can return to work*; and
	if symptoms, such as coughing and sneezing continue after an employee is cleared to return to work, the employee should wear a mask during resident care and activities and must practice good respiratory hygiene/cough etiquette and frequent hand hygiene.CMS Ex. 11 at 4.

**Facility policy:  monitoring and surveillance – employees**.  The facility policy for monitoring and screening employees directs the facility to:

*screen all employees prior to the beginning of their shift and every four hours*; any identified as ill should be sent home and asked to contact their primary care physician;
	screen all essential consultants and contracted staff at the facility entrance; any identified as ill should be sent home and asked to contact their primary care physician;
	maintain an employee infection control log and review it daily to identify any patterns or trends of employees exhibiting signs/symptoms of COVID-19;
	ask employees who are ill if they have been tested and request the results, if available;
	obtain additional COVID-19 testing per the facility’s testing policy or as directed by the local health department/state agency infectious disease consultant; and
	refer to the state agency’s “COVID-19 Contacts from Isolation and Quarantine” and consult with the local health department on when an employee can return to work.CMS Ex. 11 at 5.

Page 10

**Facility policy:  education**.  The facility policies include directions for educating staff and others.  They instruct the facility to:

*in-service staff on COVID-19 symptoms*, respiratory hygiene/cough etiquette, hand hygiene, standard precautions, droplet precautions, and personal protective equipment (PPE) (“Facility should be proactive in providing this education and should provide additional education if COVID-19 activity is suspected or is occurring in the community.”);
	provide information regarding COVID-19 that is accessible to residents, staff, and visitors;
	inform staff and visitors that they may be informed if they have had close contact with a suspected case of COVID-19 and should avoid working or visiting until cleared by the local health department;
	inform staff if an employee or resident has tested positive or is presumed positive for COVID-19; and
	in-service staff on all updates or changes to the COVID-19 control measures.CMS Ex. 11 at 5.

**Facility policy:  testing staff and residents**.  The stated purpose of the facility’s testing policy is to prevent COVID-19 from entering and spreading through the facility.

According to the policy, routine staff testing is based on the community positivity rate for the prior week.  If low, staff are tested a minimum of once a month; if medium, once a week; and, if high, twice a week.

*Staff (employees, consultants, contractors, volunteers, and care-givers) displaying symptoms of COVID-19 must be tested and restricted from working pending the test results*.  The facility must notify the facility’s medical director and obtain orders for Antigen or PCR testing.5  Use of standing orders for staff testing is optional.  The policy does not recommend repeat testing for staff who have tested positive until more than 90 days after receiving positive test results.  CMS Ex. 11 at 7.

Page 11

*Residents displaying symptoms of COVID-19 must be tested*.  Staff are required to notify the physician of the resident’s symptoms and obtain orders for testing.  Standing orders are optional.  Residents with symptoms must be placed on transmission-based precautions until the test results are received.  As with staff, the policy does not recommend repeat testing for residents who have tested positive until more than 90 days after receiving positive test results.  CMS Ex. 11 at 7.

If there is *a single new case of COVID-19 in any staff member or resident, all staff and residents should be tested*, preferably (using the more reliable) PCR testing.  CMS Ex. 11 at 7.

**Facility policy:  documentation of testing**.  The facility policy requires that its testing be documented.  Specifically:

for routine testing, document the county positivity rate, corresponding testing frequency, the date each positivity rate was collected, dates testing was performed, type of testing completed, and the results of the testing;
	document *the date and time a resident or staff member exhibits signs/symptoms of COVID-19 and the actions the facility has taken* (i.e., resident placed on transmission-based precautions, resident tested, staff member tested, staff member sent home);
	document the date the resident or staff member was tested and the type of testing used, the date the test results were received, and the results of the test.  For residents, maintain this documentation in the resident’s medical record.  For staff, the facility must document testing results “in a secure manner[,] consistent with the requirements”;
	for an outbreak of COVID-19 (defined as *one confirmed test of a staff member or a resident*), document the date the case was identified, the date that all residents and staff were tested, the type of testing used and the results of the testing;
	retest, every 3-7 days, staff and residents who test negative during an outbreak, until no further positive tests are identified for 14 consecutive days; and
	if supplies are running short, document the steps taken to obtain testing supplies, such as contacting state and local health departments to assist with testing efforts.CMS Ex. 11 at 8.

Page 12

If vendors or volunteers were tested from another source, the facility must make “every effort” to obtain the testing results.  And, if the tests cannot be processed and the results received within 48 hours, the facility should contact the lab and document the reason for the delay in obtaining the test result.  CMS Ex. 11 at 8.

**Facility policy:  emergency plan for infectious diseases/epidemic/pandemic**.  The facility’s policies include an “emergency plan.”  It provides that:

the facility will monitor infectious diseases;
	facility staff will notify the corporate team, local health department, and/or the state agency “based on the Required Reporting of Infectious Diseases Guidelines”;
	the facility will follow all required infection control policies and recommendations from the CDC, local, state, and federal authorities;
	when notified, by the local or state health agency, that a case is in the coverage area, *the facility will activate “specific surveillance and screening protocols,”* as instructed by the CDC, local, state, and federal authorities;
	the facility will “monitor the situation” and identify specific signs, symptoms, incubation period, route of infections, risks of exposure, types of precautions, required PPE, and other infection-related recommendations from the CDC, OSHA (Occupational Safety and Health Administration), and local, state, and federal authorities;
	the facility will monitor contact tracing of exposed individuals and monitor for additional cases under the guidance of the CDC and local, state, and federal authorities;
	collaborating with state, regional, and federal authorities, the facility will review and revise its internal policies and procedures to ensure consistency with their recommendations;
	facility staff will be educated “on steps and recommendations from public health authorities,” including basic infection control prevention techniques (e.g., hand hygiene) and infection prevention measures taken by the facility to mitigate the occurrence and spread of infectious disease;
	residents and families will be educated and/or provided resources to access infection prevention strategies from public health authorities; andPage 13

the facility will provide resources to help detect and prevent the spread of infectious diseases through screening forms it develops, following public health authority recommendations.CMS Ex. 11 at 14.

**Facility policy:  staffing for COVID-19**.  The facility’s staffing policy acknowledges that it might need to implement “crisis capacity strategies related to the declared national emergency to continue to provide resident care.”  CMS Ex. 11 at 16.  The policy repeats the admonition that *employees with symptoms of a respiratory infection should not report to work*.  It again directs the facility to screen all employees prior to the beginning of a shift and in the middle of the shift.  Any staff member identified as ill should be sent home.  CMS Ex. 11 at 16.

With respect to infected or symptomatic staff returning to work, the policy provides that, in a non-crisis staffing situation, the employee will not be allowed to return to work until public health authorities have been notified for guidance.

In a staffing crisis situation, any employee with suspected or diagnosed COVID *that is asymptomatic* will be allowed to work, but only to:

provide direct care for patients with confirmed COVID-19, preferably in a cohort setting;
	provide direct care for patients with suspected COVID-19; and
	as a last resort, provide direct care for patients without suspected or confirmed COVID-19.
	infected and asymptomatic staff are restricted from working with severely immune-compromised residents.The policy reiterates that any employee with suspected or diagnosed COVID-19 *who is symptomatic will not be allowed to work until meeting “criteria.”*  The policy directs the facility to refer to “COVID-19 Cases and Contacts from Isolation and Quarantine” and directs the facility *to consult with the local health department on when an employee can return to work*.  CMS Ex. 11 at 16.

The policy then lists seven criteria for determining that crisis staffing exists:

The facility has a recent COVID-19 positive test of a resident or staff.
	Alternative placement has been considered.Page 14

Asymptomatic and willing employees cannot fill the necessary shifts to fulfill staffing needs.
	Attempts to obtain assistance from sister facilities have been completed.
	Attempts to obtain assistance from the Primary Health Care agency have been completed.
	Attempts to obtain assistance from contracted agencies have been completed.
	The facility has notified the local Illinois Department of Public Health regarding the need to enact the crisis staffing situation.CMS Ex. 11 at 16.

**C.  The facility’s deficiencies**.****The facility’s COVID-19 statistics are dramatic.  In late December 2020, 50 residents lived in the facility.  CMS Ex. 12 at 1-2.  By January 19, 2021, 49 of those residents had tested positive for COVID-19, and 12 of them had died from the disease.  CMS Ex. 8 at 1; CMS Ex. 12 at 1-2, 4; CMS Ex. 30 at 2 (McFarlin Decl. ¶ 5).  Disturbing as these numbers are, they do not, by themselves, establish the facility’s substantial noncompliance with program requirements.  The critical question is:  did the facility implement its policies (and follow CDC guidelines) for preventing the spread of the infection?  If it did, it was likely in substantial compliance with section 483.80(a), notwithstanding the prevalence of the disease within the facility.  But if it did not implement these policies and guidelines, it was not in substantial compliance.  *Golden Living Ctr. – Superior*, DAB No. 2768 at 7; *Heritage House of Marshall*, DAB No. 2566 at 12.

**Deficiency:  first failure to test**.  On December 21, 2020, a nurse aide, identified as **V14**, tested positive for COVID-19.  CMS Ex. 15 at 1; CMS Ex. 30 at 2 (McFarlin Decl. ¶ 6); *see* CMS Ex. 7 at 1 (identity key for facility staff).  She had most recently worked at the facility on December 17 and 18, 2020.  CMS Ex. 17 at 9.  As noted above, the facility policy required that *all*staff and *residents be tested whenever the facility had a single new case of COVID-19, whether a staff member or resident*.  CMS concedes that the facility tested staff at that time.  CMS Br. at 12; *see, e.g.*, CMS Ex. 14 at 16, 22, 29.  But, contrary to its policy, the facility did not then test its residents for the disease.  *See* CMS Ex. 11 at 7; CMS Ex. 12.

About a week after Nurse Aide V14 tested positive, the facility’s first resident tested positive.  Resident 1 (**R1**) suffered from chronic obstructive pulmonary disorder.  For two or three days, he experienced increased difficulty breathing, with shortness of breath and a productive cough, which are symptoms of COVID-19.  Yet, contrary to the facility

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policy requiring that residents displaying symptoms of COVID-19 be tested, the facility did not test him for COVID-19.  *See* CMS Ex. 11 at 7.  On December 27, 2020, R1 went to the emergency room where he tested positive for the disease.  CMS Ex. 8 at 1; CMS Ex. 9 at 1; CMS Ex. 30 at 3 (McFarlin Decl. ¶ 7); *see* CMS Ex. 6 at 1 (identifying residents).  This time, in accordance with the facility’s testing policy, the facility tested all residents (using antigen tests rather than the more reliable PCR).  *See* CMS Ex. 11 at 7.  Twenty-one of the 50 residents tested positive.  CMS Ex. 12 at 6-7.  Fourteen staff members also tested positive.  CMS Ex. 14 at 6-7.

The facility continued its testing through January 8, 2021.  By then, every facility resident, except one, had contracted the disease.  CMS Ex. 12 at 4, 8-10.  Additional staff members tested positive through January 11, 2021.  CMS Ex. 14 at 3.

Failing to test residents immediately, when Nurse Aide V14 tested positive, was a serious error, with significant consequences (discussed below).  By itself, this failure to follow its own policy endangered the health and welfare of residents and put the facility out of substantial compliance with program requirements.  It was not, however, the facility’s only deficiency.

**Deficiency:  inadequate screening and allowing symptomatic and infected staff to continue working**.  The facility’s written policies directed it to screen its employees at the beginning of each shift and then every four hours.  CMS Ex. 11 at 5.  As the undisputed evidence establishes (and as discussed below), the facility limited its screening to the beginning of the shift; it did not screen its employees every four hours.  And the screening was not always effective because staff did not accurately report their symptoms and, even when staff did so, they were allowed to work.

Samantha Hammann, a laundry aide/housekeeper (identified as **V4)**,6 told Surveyor Kelly McFarlin that she worked from December 25 through 28, even though she had a *runny nose, nasal drainage, and a cough*, all symptoms of COVID-19, as the facility’s COVID-19 Infection Control Measures confirm.  CMS Ex. 11 at 3.  Laundry Aide Hammann reported to work, notwithstanding the facility policy dictating that staff be educated *not to report to work if having symptoms of a respiratory infection*.  Laundry Aide Hammann also admitted that she did not report her symptoms.  She nevertheless maintained that the nurse aides working that weekend were aware of them.  CMS Ex. 30 at 3 (McFarlin Decl. ¶ 9); *see* CMS Ex. 11 at 4, 16; CMS Ex. 17 at 8.

When statements are made by the facility’s employees, and those individuals have not refuted them, they may constitute substantial evidence.  *See* *Beatrice State Developmental Ctr.*, DAB No. 2311 at 17, 18 (2010) (pointing out that the facility could

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have but did not present employee testimony that refuted the statements the surveyors claimed they made);*Omni Manor Nursing Home*, DAB No. 1920 at 11 (2004) (holding that statements of facility employees to the surveyors may be admitted in an administrative proceeding and may constitute substantial evidence).

In fact, Laundry Aide Hammann does not deny telling Surveyor McFarlin that she continued to work, notwithstanding her symptoms, and that she misrepresented those symptoms on her screening form.  Consistent with what she told the surveyor, she concedes in her written declaration that, on December 25, 2020, she *started* experiencing “a dry cough” and “a slightly runny nose-like sniffles.”  She also concedes that she did not take a COVID test, that she misrepresented her symptoms on the facility’s screening questionnaire, and that she continued working.  P. Ex. 5 at 1 (Hammann Decl. ¶¶ 3, 4).  A copy of her screening questionnaire confirms that she denied having a cough, “runny nose,” or nasal drainage, even though she had those symptoms.  CMS Ex. 16 at 1.

Petitioner justifies the laundry aide’s failing to report her symptoms and her continuing to work by claiming that she thought she was “experiencing seasonal allergies due to her history of seasonal allergies at that time of year” and had no reason to believe that she was experiencing symptoms of COVID-19.7  P. Br. at 4.  According to Laundry Aide Hammann’s written declaration, there were no cases of COVID-19 in the building at the time (which is not true, although she may not have known that); she wore personal protective equipment while working; and she did not have a fever.  P. Ex. 5 at 1-2 (Hammann Decl. ¶¶ 4-7).

Contrary to the Laundry Aide Hammann’s assumption, *there were cases* of COVID-19 in the facility.  We know that Nurse Aide V14 tested positive days before Laundry Aide Hammann reported for work with COVID symptoms.  We also know that R1 was exhibiting COVID-19 symptoms at about the same time as Laundry Aide Hammann.  For reasons Petitioner does not explain, Laundry Aide Hammann was apparently not aware of any of this.  It is impossible to know whether she would have changed her behavior had she known; her declaration suggests that she might have.  Moreover, even if COVID had not yet been detected in the facility, Laundry Aide Hammann violated facility policies when she repeatedly reported for work, notwithstanding her COVID symptoms.  The policy is unequivocal and does not allow for exceptions based on the staff member’s alternative explanation or self-diagnosis.  CMS Ex. 11 at 16.

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Laundry Aide Hammann also affirmatively misrepresented her symptoms on the facility’s screening form, for which the facility is accountable.  CMS Ex. 16 at 1; CMS Ex. 30 at 3 (McFarlin Decl. ¶ 9); *see* P. Ex. 5 at 1 (Hammann Decl. ¶ 4).  Petitioner justifies these misrepresentations by claiming that the laundry aide’s symptoms were not “new or worsening.”  P. Br. at 4.  This is not wholly consistent with Laundry Aide Hammann’s written declaration, in which she declares her symptoms started on December 25.  P. Ex. 5 at 1 (Hammann Decl. ¶ 3).  In any event, with respect to her nasal symptoms, she was not asked whether those symptoms were new or worsening.  The question is straight-forward:  “Do you have a ‘runny nose’ or nasal drainage?”  And Laundry Aide Hammann answered “no,” which was untrue.  Either she did not understand the importance of answering the screening questions accurately, which shows inadequate training, or she had been properly trained and chose to disregard those instructions.  Either way, the facility is accountable.  It is well-settled that a facility “cannot disavow responsibility for the actions of its employees” through which it acts.  *Springhill Senior Residence*, DAB No. 2513 at 14 (2013), citing *Beverly Health Care Lumberton*, DAB Ruling No. 2008-5 (Denial of Petition for Reopening Decision No. 2156) at 6-7 (2008); *Emerald Oaks*, DAB No. 1800 at 7 n.3 (2001); *North Carolina State Veterans Nursing Home, Salisbury*, DAB No. 2256 (2009).

Petitioner also justifies allowing the symptomatic laundry aide/housekeeper to work by claiming, without underlying support, that Laundry Aide Hammann had no direct contact with residents during her shifts on December 25, 26, 27, or 28.  P. Br. at 4.  No evidence supports this claim, and, for purposes of summary judgment, I need not accept the unsupported assertions of counsel.  *Ill. Knights Templar*, DAB No. 2274 at 4 (2009); *Livingston Care Ctr.*, DAB No. 1871 at 5 (2003), aff’d*Livingston Care Ctr. v. Dep’t of Health & Human Services*, 388 F.3d 168 (6th Cir. 2004).  Laundry Aide Hammann does not say, in her written declaration, that she had no direct contact with residents.  To the contrary, she states that she and her supervisor spent December 28 moving residents from the non-COVID portion of the facility into the COVID isolation area, which necessarily would have exposed her to residents who were not symptomatic or COVID-positive and who remained in the general unit.  P. Ex. 5 at 2 (Hammann Decl. ¶ 7).  She also told Surveyor McFarlin that, on December 28, she was “all over the building,” helping with room moves and cleaning resident rooms.  CMS Ex. 8 at 1.  She has not refuted this.  *See* CMS Br. at 10.

Laundry Aide Hammann was tested on December 28, along with everyone else (in response to R1’s positive test).  She tested positive and left the facility.  P. Ex. 5 at 2 (Hammann Decl. ¶¶ 8, 9).  She did not return to work until January 8, 2021.  P. Ex. 5 at 2 (Hammann Decl. ¶ 9).

Laundry Aide Hammann was not the only staff member who reported for work even though she was experiencing COVID symptoms.  The facility’s housekeeping supervisor, Luisa Ortiz (identified as **V3),** told Surveyor McFarlin that she developed a cough on

Page 18

December 27, 2020, when she was off work.  She recognized that she had a COVID symptom.  On the morning of December 28, she went to the facility and took the less reliable, but rapid, Antigen test.  The Regional Director of Operations (identified as **V6**) performed the test and knew that Supervisor Ortiz was symptomatic.

Supervisor Ortiz tested negative.  Contrary to guidelines issued by the Centers for Disease Control and Prevention (CDC), the facility did not follow-up with the more sensitive PCR test before it allowed her to return to work.  *See* CMS Ex. 20 at 6.  Instead, as Supervisor Ortiz told Surveyor McFarlin, she reported for work at about 10:30 a.m. that day.  CMS Ex. 30 at 4 (McFarlin Decl. ¶ 9).  She filled out a screening form and “thought” that she’d indicated that she had a cough.8  The facility did not screen her (or other employees) four hours after the initial screening.  During her shift, Supervisor Ortiz developed additional symptoms.  When she tested again late in the day (as part of the facility-wide test, implemented in response to R1’s positive test), she tested positive.  CMS Ex. 14 at 6; P. Ex. 4 at 2 (Ortiz Decl. ¶¶ 5, 7).

In her written declaration, Supervisor Ortiz concedes that she started experiencing a dry cough on December 27, 2020.  P. Ex. 4 at 1 (Ortiz Decl. ¶ 3).  After testing negative on the morning of December 28, she reported for work, but her symptoms, including fatigue and chest tightness, increased.  P. Ex. 4 at 1, 2 (Ortiz Decl. ¶¶ 4, 9).  She and Laundry Aide Hammann worked together that day, moving COVID-positive residents into the COVID isolation area.  P. Ex. 4 at 2 (Ortiz Decl. ¶¶ 5, 6, 7); P. Ex. 5 at 2 (Hammann Decl. ¶¶ 5, 7).9

Even though Supervisor Ortiz had tested positive for COVID, had a dry cough, increased

fatigue, and chest tightness, she returned to work on December 29 and 31, 2020, and January 2, 3, and 4, 2021.  She justifies doing so because she had no fever or additional symptoms (other than the cough, increased fatigue, and chest tightness), wore full

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personal protective equipment, and worked with COVID-positive residents in the COVID unit.  P. Ex. 4 at 2 (Ortiz Decl. ¶¶ 8, 9).  Notwithstanding these claims, on January 5, she reported to the hospital because she was having difficulty breathing.  CMS Ex. 8 at 2.10

The facility’s policy prohibited COVID-infected employees, or those with symptoms of COVID from reporting to work.  CMS Ex. 11 at 4.  Any employee identified as ill was supposed to be sent home and asked to contact a primary care physician.  CMS Ex. 11 at 5.  The facility was also required to consult the local health department before an employee with diagnosed COVID-19 could return to work.  CMS Ex. 11 at 4, 16.  CMS argues that the facility was not in substantial compliance because, contrary to its written policy, it allowed staff to work even though they had contracted COVID or had symptoms of COVID.  CMS Br. at 10- 12; *see* CMS Ex. 11 at 16; P. Ex. 3 at 2 (CDC guidance directing facilities to remind health care personnel not to report to work when ill).

Petitioner, on the other hand, claims that allowing infected employees to work was in keeping with CDC guidelines.  P. Br. at 5-7; *see* P. Ex. 3.  According to Teri Linville, the Regional Director of Clinical Operations for Peterson Health Care (the facility’s corporate management company), in December 2020 and January 2021, the facility “was at crisis staffing due to the numbers [of] employees and residents who had tested positive for COVID-19.”  P. Ex. 6 at 2 (Linville Decl. ¶ 4).  It was the facility’s “understanding” that COVID-positive employees with “mild, improving symptoms” could work with COVID-19 positive residents in COVID-19 positive units.  P. Ex. 6 at 2 (Linville Decl. ¶ 5).

Other than Regional Director Linville’s assertion that residents and staff had tested positive for COVID-19, Petitioner has come forward with little explanation or evidence showing that the facility met criteria for “crisis staffing” (e.g., that it had considered alternative placements and attempted to obtain assistance elsewhere).  *See* CMS Ex. 11 at 16.1  On the other hand, evidence shows that the facility consulted the local health authorities, which suggests that local health officials agreed that the facility was in crisis.  *But see* CMS Ex. 14 at 8-10 (showing that, as of December 29, 30, and 31, the vast majority of staff continued to test negative for the disease).  For purposes of summary

Page 20

judgment, and drawing all reasonable inferences in the facility’s favor, I will accept that the facility met its requirements for crisis staffing.

In keeping with its written policies, the facility consulted the local health department about allowing infected personnel to return to work.  E-mail correspondence, dated December 28, 2020, between facility staff and the local health department includes lists of the staff members who were approved to return to work on the facility’s COVID unit.  *Supervisor Ortiz was not among them*.  She was not approved to return to work.  (Paradoxically, Laundry Aide Hammann, who did not return to work until January 8, is on the approved list).  CMS Ex. 19 at 2-3.

Significantly, the facility understood and represented to the local health authorities that *only asymptomatic* staff were allowed to work.  In her email to the local health authorities, the facility’s regional director wrote, “Thank you for allowing us to bring back our *asymptomatic* staff to work on the Covid Unit.”  CMS Ex. 19 at 2 (emphasis added).

Thus, the undisputed evidence establishes that, contrary to its own policies, the facility did not screen its staff for COVID every four hours.  It screened only at the start of a shift.  Its screening was not completely reliable because staff failed to disclose their symptoms.  Even when they reported their COVID symptoms, staff were allowed to work.  These deficiencies put the facility out of substantial compliance with program requirements.

***The undisputed evidence establishes that CMS’s determination that the facility’s deficiencies posed immediate jeopardy to resident health and safety is not clearly erroneous.*****Immediate jeopardy**.  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.  CMS’s determination as to the level of a facility’s noncompliance (which would include an immediate jeopardy finding) must be upheld unless it is “clearly erroneous.”  42 C.F.R. § 498.60(c).  The Board has observed repeatedly that the “clearly erroneous” standard imposes on facilities a “heavy burden” to show no immediate jeopardy and has sustained determinations of immediate jeopardy where CMS presented evidence “from which ‘[o]ne could reasonably conclude’ that immediate jeopardy exists.”  *Barbourville Nursing Home*, DAB No. 1962 at 27-28 (2005), *citing Koester Pavilion*, DAB No. 1750 (2000); *Daughters of Miriam Center*, DAB No. 2067 at 7, 9 (2007).

Once CMS presents evidence supporting a finding of substantial noncompliance, it need not offer evidence to support its immediate jeopardy determination.  The burden is on the *facility* to show that CMS’s determination is clearly erroneous.  *Grace Healthcare of*

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*Benton*, DAB No. 2189 at 13 (2008), citing *Liberty Commons Nursing & Rehab Center- Johnston*, DAB No. 2031 at 17-18 (2006), *aff’d*, *Liberty Commons Nursing & Rehab Ctr. – Johnston v. Leavitt*, 241 Fed.Appx. 76 (4th Cir. 2007).  The harm or threatened harm is presumed to be serious, and the facility has the burden of establishing that the harm or threatened harm “did not meet any reasonable definition of ‘serious.’”  *Maysville Nursing and Rehabilitation*, DAB No. 2874 at 21 (2018), quoting *Libertywood Nursing Ctr*., DAB No. 2433 at 18 (2011), *aff’d Libertywood Nursing Ctr. v. Sebelius*, 512 Fed.Appx. 285 (4th Cir. 2013).

With respect to the standard for determining whether immediate jeopardy exists, I need not find that the facility’s noncompliance caused actual harm or injury to a resident.  So long as the deficiencies are *likely* to cause serious injury or harm, they pose immediate jeopardy.

Petitioner claims that it “did not have a single positive COVID-19 resident prior to December 28, 2020.”  P. Br. at 8.  This is simply not so.  The facility did not *know* that its residents were infected prior to December 28 because – contrary to its policies – it did not test them.  R1 was plainly infected prior to that date because he tested positive at the hospital on December 27, 2020.  And his symptoms began two or three days before then.  CMS Ex. 8 at 1; CMS Ex. 9 at 1; CMS Ex. 13 at 2; CMS Ex. 30 at 3 (McFarlin Decl. ¶ 7).  When the facility finally tested, a whopping 42% (21 of 50) of its residents tested positive.  They did not all suddenly contract the disease on December 28.

Petitioner also claims that, because staff – including infected and symptomatic staff – wore personal protective equipment while working, the facility’s deficiencies would not have posed immediate jeopardy.  Certainly, wearing adequate personal protective equipment reduces the risk of spreading COVID, when compared to not wearing it.  By itself, however, as the facility’s own experience establishes, it does not prevent the possibility of an infected individual transmitting the COVID virus.  CMS Ex. 30 at 4-5 (McFarlin Decl. ¶ 11).  Other safeguards, as outlined in the facility’s policies, must be implemented as well to keep the residents safe.

Failing to follow all those infection control policies during the outbreak of an infectious disease is likely to cause serious harm to facility residents.  In *Golden Living Ctr. – Superior*, for example, the Board concluded that it was not clearly erroneous for CMS to determine that the facility’s failure to implement – fully and promptly – influenza control precautions posed immediate jeopardy to resident health and safety.  DAB No. 2768 at 25-26.  There, the facility had failed to implement the infection control protocols specifically designed and intended to contain an outbreak of influenza, a contagious virus known to cause substantial illness and even death to many long-term-care residents.  The Board observed that the facility’s own experience established that the likelihood of serious harm to residents from the spread of the disease was neither hypothetical nor insubstantial.  Five residents contracted the disease within a two-week period.  Here, the

Page 22

facility’s experience even more dramatically establishes that the “likelihood of serious harm to residents from the spread of [the disease] was neither hypothetical nor insubstantial.”

Here, the facility did not follow its policies for testing residents.  It allowed COVID-infected and symptomatic staff to continue working.  The facility acknowledged to the local health care authorities that symptomatic staff should not be allowed to work and recognized that infected staff should not return to work unless approved by the local health care authorities.  Yet, Supervisor Ortiz, who was infected and displayed worsening symptoms, continued to work without such approval.

Petitioner has thus not met its burden of establishing that the immediate jeopardy determination is clearly erroneous.

***The penalties imposed – $11,395 per day for the period of immediate jeopardy and $435 per day for the period of substantial noncompliance that did not pose immediate jeopardy – are reasonable.***To determine whether a civil money penalty is reasonable, I apply the factors listed in 42 C.F.R. § 488.438(f):  (1) the facility’s history of noncompliance; (2) the facility’s financial condition; (3) factors specified in 42 C.F.R. § 488.404; and (4) the facility’s degree of culpability, which includes neglect, indifference, or disregard for resident care, comfort or safety.  The absence of culpability is not a mitigating factor.  The factors in 42 C.F.R. § 488.404 include:  (1) the scope and severity of the deficiency; (2) the relationship of the deficiency to other deficiencies resulting in noncompliance; and (3) the facility’s prior history of noncompliance in general and specifically with reference to the cited deficiencies.

I consider whether the evidence supports a finding that the amount of the CMP is at a level reasonably related to an effort to produce corrective action by a provider with the kind of deficiencies found, and in light of the section 488.438(f) factors.  I am neither bound to defer to CMS’s factual assertions nor free to make a wholly independent choice of remedies without regard for CMS’s discretion.  *Barn Hill Care Ctr.*, DAB No. 1848 at 21 (2002); *Cmty. Nursing Home*, DAB No. 1807 at 22 *et seq*. (2002); *Emerald Oaks*, DAB No. 1800 at 9 (2001); *CarePlex of Silver Spring*, DAB No. 1683 at 8 (1999).

I determine whether a penalty is reasonable based on the per-day penalty, not the total accrued penalty.  *Crawford Healthcare and Rehabilitation*, DAB No. 2738 at 20 (2016).

Penalties are inflation-adjusted and change annually.  The amount is determined as of the date the penalty is assessed, in this case, June 23, 2021.  CMS Ex. 4; 85 Fed. Reg. 2869, 2880 (Jan. 17, 2020).  CMS imposed penalties of $11,395 per day for the period of immediate jeopardy.  This amount is at the low end of the penalty range for situations of

Page 23

immediate jeopardy ($6,808 to $22,320).  CMS imposed a penalty of $435 per day for the period of substantial noncompliance that did not pose immediate jeopardy, which is at the very low end of the range ($112 to $6,695).  42 C.F.R. §§ 488.408(e), 488.438; 45 C.F.R. § 102.3; 85 Fed. Reg. 2869, 2880 (Jan. 17, 2020).

Considering the relevant factors, these amounts are reasonable.

The facility has a less-than stellar compliance history.

For the recertification survey immediately preceding this survey, completed on February 7, 2020, it had multiple life safety code deficiencies, cited at scope and severity level F (widespread noncompliance).  On the health side, it was not in substantial compliance with the quality-of-care regulation, 42 C.F.R. § 483.25 (Tag F689), cited at scope and severity level G, which means a resident suffered actual harm.  CMS Ex. 25 at 3.
	Less than a year earlier, for a complaint survey completed on September 5, 2019, the facility was also not in substantial compliance with section 483.25, and the deficiency caused actual harm (scope and severity level G).  CMS Ex. 25 at 3-4.
	For the recertification survey completed on February 7, 2019, the facility was not in substantial compliance with the infection control regulation (Tag F880).  The deficiency was cited at scope and severity level F.  CMS Ex. 25 at 4.
	For the survey completed January 19, 2018, the facility was not in substantial compliance with the infection control regulation (Tag F880) as well as requirements to safeguard medical records, 42 C.F.R. § 483.70(i) (Tag F842).  The deficiencies were cited at scope and severity level E.  CMS Ex. 25 at 4.By itself, the facility’s history justifies these relatively low penalties.

Petitioner does not claim that it is unable to pay the penalty.

With respect to the remaining factors, I have discussed in detail the facility’s deficiencies and its disregard for its own written policies.  For this, the facility is culpable, and the penalty is reasonable.

IV.    Conclusion

The undisputed evidence establishes that, from January 11, 2021, through February 4, 2021, the facility was not in substantial compliance with Medicare program requirements governing infection control, and, from January 11 through 19, 2021, its deficiencies posed immediate jeopardy to resident health and safety.

Page 24

The penalties imposed are reasonable.

Endnotes

1  Deciding a case on summary judgment (or on the written record) does not mean that it is decided without a hearing.  In reviewing administrative appeals decided on summary judgment, courts describe the case as having been decided without an “oral hearing” or without an “evidentiary hearing.”  They recognize that, by considering the evidence and applying the law, the ALJ has granted the petitioner a hearing.  *See* *CNG Transmission Corp. v. FERC*, 40 F.3d 1289, 1293 (D.C. Cir. 1994) (holding that a “paper hearing” satisfies statutory requirements for “notice and opportunity for hearing.”).  Thus, granting summary judgment (or deciding a case on the written record) satisfies the hearing requirements of sections 205(b) and 1866(h) of the Act.  *See* 42 C.F.R. § 498.66(d) (discussing a hearing without oral testimony).

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

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

4  In 2016, the infection-control regulation was redesignated from 42 C.F.R. § 483.65 to 42 C.F.R. § 483.80.  81 Fed. Reg. 68688 (Oct. 4, 2016).  The substance did not change, and cases decided prior to that redesignation are sound.

5  An Antigen test produces results within minutes.  Positive results are accurate and reliable.  However, Antigen tests are generally less sensitive and tend to be less accurate than PCR (polymerase chain reaction) tests, especially when symptoms are not present.  A single antigen test cannot rule out infection.  CMS Ex. 20; CMS Ex. 30 at 2 (McFarlin Decl. ¶ 4); https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/testing.html.

6  I have identified by name only those employees who submitted written declarations.

7  Although less common, “seasonal allergies” occur in winter.  These are generally indoor allergies, triggered by dust mites, mold, pet dander, or other indoor allergens.  *See* https://www.health.harvard.edu/staying-healthy/how-can-i-reduce-symptoms-from-my-winter-allergies.

8  The screening record for Supervisor Ortiz is ambiguous.  Unlike other staff, she answered the screening questions with an “N” or a “Y” rather than “No” or “Yes.”  The problem is that the entry for December 28 appears to include both an “N” and a “Y.”  CMS Ex. 16 at 2.  One was written on top of the other, and it is impossible to determine which was her final response and when the change was made.  The facility should have clarified her answer.  Nevertheless, for purposes of summary judgment, I accept that she disclosed her symptom at the time she filled out the form and did not alter her response later.

9  Supervisor Ortiz insists that she worked with COVID-positive residents only.  P. Ex. 4 at 2 (Ortiz Decl. ¶ 6).  However, like Laundry Aide Hammann, she moved residents from the uninfected unit to the isolation area.  She must therefore have been working part of the time in the areas that housed COVID-negative residents.

10  Supervisor Ortiz reported this January 5 hospital visit to Surveyor McFarlin.  She has not denied it.  CMS Ex. 8 at 2.

11  The facility was supposed to have developed a strategy for mitigating staffing shortages.  This included developing criteria for determining when such staff could return to work and what work they could perform.  P. Ex. 2 at 1-3.  The record does not include evidence of this strategy.  However, CMS has not cited that as a problem.
  
          /s/
        Carolyn Cozad Hughes

                      Administrative Law Judge Back to top
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