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                              Mansion Nursing & Rehabilitation Center, DAB CR6393 (2023)
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Mansion Nursing & Rehabilitation Center, DAB CR6393 (2023)








  
  
    

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





Mansion Nursing & Rehabilitation Center
(CCN: 415097),
Petitioner,

v.

Centers for Medicare & Medicaid Services.
Docket No. C-21-589Decision No. CR6393November 15, 2023

        
              
    

      DECISION

During the coronavirus disease of 2019 (COVID or COVID-19) pandemic, the Rhode Island Department of Health (RIDOH), Division of Facilities Regulation (state agency) conducted a COVID-19 Focused Infection Control Survey from November 24 through 30, 2020, at Mansion Nursing & Rehabilitation Center (Petitioner or facility).  The state agency determined that Petitioner failed to implement its COVID-19 infection control program (ICP), resulting in noncompliance, at the immediate jeopardy level, with the Medicare requirement that each skilled nursing facility (SNF) maintain an infection prevention and control program (42 C.F.R. § 483.80(a)(1), (2)).  The Centers for Medicare & Medicaid Services (CMS) agreed with the state agency and imposed a per-day civil money penalty (CMP) of $15,975 for six days (November 24 through 29, 2020) of immediate jeopardy-level noncompliance, and a per-day CMP of $225 for 30 days (November 30 through December 29, 2020) of noncompliance below the immediate jeopardy level, for a total CMP of $102,600.

Petitioner requested a hearing to dispute the allegations of noncompliance.

**Page 2**

As explained below, I uphold most of the allegations used to support the finding of noncompliance; however, I do not uphold all of them.  The allegations I uphold are sufficient to show that Petitioner immediately jeopardized the health and safety of residents. Further, while the allegations I uphold in this case support a significant CMP, I conclude that, based on a review of relevant statutory and regulatory factors for setting CMP amounts, the per-day CMP amount imposed for the period of immediate jeopardy is no longer reasonable in light of my conclusion not to sustain all of CMS’s allegations of noncompliance against Petitioner.  Therefore, I reduce the CMP amount for the period of immediate jeopardy-level noncompliance to $13,975 per day.  Because the CMP for the period of noncompliance below the immediate jeopardy level is already near the bottom of the penalty range, I uphold that CMP amount. Therefore, Petitioner is liable for a total CMP of $90,600.

I.     Legal Framework

The Medicare program “provides basic protection against the costs of . . . related post-hospital . . . care” for individuals over the age of 65 who are eligible for Social Security retirement benefits and for individuals under 65 who meet other criteria.  42 U.S.C. § 1395c.  Post-hospital care includes extended care services provided at an SNF.  42 U.S.C. §§ 1395f(a)(2)(B), 1395x(h)-(i).

For Medicare program purposes, an SNF is an institution that is primarily engaged in providing skilled nursing care and/or rehabilitation services for its residents but is not primarily engaged in the care and treatment of mental diseases.  42 U.S.C. §§ 1395x(j), 1395i-3(a)(1).  Because an SNF is a “provider of services” in the Medicare program, each SNF that participates in the program must file a provider agreement with the Secretary of Health and Human Services (Secretary). 42 U.S.C. §§ 1395cc(a), 1395x(u).

In addition to complying with the terms of the provider agreement, a participating SNF must meet a variety of ongoing statutory requirements regarding how it provides services, maintains the rights of its residents, and administers its facility.  42 U.S.C. § 1395i-3(a)(3), (b)-(d).  Further, SNFs must comply with “such other requirements relating to the health, safety, and well-being of residents or relating to the physical facilities thereof as the Secretary may find necessary.”1  42 U.S.C. § 1395i-3(d)(4)(B); *see* 42 U.S.C. § 1395i-

**Page 3**

3(c)(1)(xi), (f).  The Secretary has promulgated regulations to establish those additional requirements.  *See* 42 C.F.R. pt. 483, subpt. B.2

When an SNF fails to meet a statutory or regulatory participation requirement, then the SNF has a “deficiency.”  42 C.F.R. § 488.301; *see* 42 U.S.C. § 1395i-3(h)(1).  “Noncompliance” means “any deficiency that causes a facility to not be in substantial compliance.” 42 C.F.R. § 488.301.  To maintain “substantial compliance,” an SNF’s deficiencies may “pose no greater risk to resident health or safety than the potential for causing minimal harm.”  42 C.F.R. § 488.301.

Broadly, noncompliance that subjects an SNF to enforcement remedies is divided into two levels.  One level comprises deficiencies that immediately jeopardize the health or safety of residents and the other level is composed of deficiencies that do not.  42 U.S.C. § 1395i-3(h)(1). “Immediate jeopardy” exists when “the provider’s noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident.”  42 C.F.R. § 488.301.

The Secretary has the duty to enforce the statutory and regulatory participation requirements for SNFs.  42 U.S.C. § 1395i-3(f)(1).  To do so, the Secretary contracts with state agencies to conduct surveys to determine whether SNFs are in substantial compliance.  42 U.S.C. §§ 1395aa(a), 1395i-3(g); 42 C.F.R. § 488.10.  Standard surveys are unannounced and occur at least once every 15 months.  42 U.S.C. § 1395i-3(g)(2)(A)(i), (iii)(I).  State agencies also conduct investigations into complaints against SNFs.  42 U.S.C. § 1395i-3(g)(1)(C), (4).  When the results of a survey show that an SNF is not in substantial compliance with program participation requirements, the Secretary may impose enforcement remedies on the SNF.  42 U.S.C. § 1395i-3(h)(2); 42 C.F.R. § 488.406.  When CMS selects an enforcement remedy to impose on an SNF, it determines the scope (i.e., the number of residents affected or potentially affected) and severity (i.e., the degree of harm or potential harm) for each deficiency.3  *See* 42 C.F.R. § 488.404(a)-(b).

**Page 4**

One such remedy is a CMP.  42 U.S.C. § 1395i-3(h)(2)(B)(ii).  CMS may impose a per‐instance CMP for each instance of the SNF’s noncompliance or a per‐day CMP for the number of days an SNF is not in substantial compliance.  42 U.S.C. § 1395i‐3(h)(2)(A), (h)(2)(B)(ii)(I); 42 C.F.R. § 488.430(a). For CMPs assessed on or after January 17, 2020, and for deficiencies that occurred after November 2, 2015, the CMP amounts may range as follows:  $2,233 to $22,320 for per-instance CMPs; $112 to $6,695 per day for less serious noncompliance; or $6,808 to $22,320 per day for more serious noncompliance that poses immediate jeopardy to the health and safety of residents. 45 C.F.R. § 102.3 (2020); 85 Fed. Reg. 2869, 2870, 2880 (Jan. 17, 2020); *see also* 42 C.F.R. § 488.438(a)(1) (providing original CMP amounts before statutory inflation adjustments).

If CMS imposes a CMP based on a finding of substantial noncompliance, then the SNF may request a hearing before an administrative law judge (ALJ) to challenge CMS’s initial determination of noncompliance that led to the imposition of an enforcement remedy and/or the level of noncompliance (if a successful challenge to the level would affect the range of CMP amounts imposed on the SNF).  42 U.S.C. §§ 1320a-7a(c)(2), 1395i‐3(h)(2)(B)(ii); 42 C.F.R. §§ 488.330(e)(3)(ii), 488.408(g)(1), 488.434(a)(2)(viii), 498.3(b)(13)-(14), (d)(10); *see also* 5 U.S.C. §§ 554, 556.  However, CMS’s choice of remedies is not reviewable. 42 C.F.R. §§ 488.438(e)(2), 488.408(g)(2), 498.3(b)(13).

If an SNF challenges the existence of a deficiency, CMS must make a prima facie case that the SNF failed to substantially comply with federal participation requirements and, if CMS makes such a showing, the SNF must then prove substantial compliance by a preponderance of the evidence.  *Hillman Rehab. Ctr.*, DAB No. 1611 at 8 (1997); *see* *Batavia Nursing & Convalescent Inn*, DAB No. 1911 (2004); *Batavia Nursing & Convalescent Ctr.*, DAB No. 1904 (2004), *aff’d*, *Batavia Nursing & Convalescent Ctr. v. Thompson*,**129 F. App’x 181 (6th Cir. 2005); *Emerald Oaks*, DAB No. 1800 (2001).  If an SNF challenges CMS’s determination as to the level of noncompliance, CMS’s determination must be upheld unless it is clearly erroneous.  42 C.F.R. § 498.60(c)(2).

If an ALJ concludes that there was a basis for imposing a CMP on an SNF, then the SNF may dispute the amount of the CMP.  The ALJ’s review of the CMP amount is limited to considering the statutory and regulatory factors for setting a CMP amount.  42 C.F.R. § 488.438(e)(3); *see*42 U.S.C. §§ 1320a-7a(d), 1395i-3(h)(2)(B)(ii)(I); 42 C.F.R. § 488.438(f).  The ALJ may not reduce a CMP to zero.  42 C.F.R. § 488.438(e)(1).

Either party may request administrative review of an ALJ’s decision.  42 C.F.R. § 498.80.

II.    Background and Procedural History

The state agency conducted a COVID-19 Focused Infection Control Survey from November 24, 2020 through November 30, 2020, to determine whether Petitioner had

**Page 5**

“proper infection prevention and control practices to prevent the development and transmission of COVID-19.” CMS Ex. 3 at 1.  The state agency concluded that Petitioner was noncompliant with 42 C.F.R. § 483.80(a)(1), (2), (4), (e), (f) (Tag F-880) (Infection Prevention and Control) at a scope and severity level of “L” (i.e., isolated deficiency posing immediate jeopardy to resident health or safety).  CMS Ex. 3 at 1.  Before the end of the survey, Petitioner submitted a plan of correction to the surveyors.  On November 30, 2020, the state agency determined the immediate jeopardy situation was abated.  CMS Ex. 3 at 1; *see* P. Ex. 2.  On December 3, 2020, the state agency issued a Statement of Deficiencies (SOD) and an initial determination imposing a directed plan of correction (DPOC) and a Denial of Payment for New Admissions (DPNA).  Hearing Req. Ex. C.

On January 12, 2021, CMS issued an initial determination in which it imposed a DPNA (effective December 19, 2020), termination of provider agreement (on June 4, 2021, if substantial compliance was not achieved by that date), a DPOC as directed by the state agency, and a CMP of $15,975 per day for six days from November 24 through November 29, 2020, and $225 per day beginning November 30, 2020, until substantial compliance was achieved by Petitioner’s facility.  CMS Ex. 1 at 1-3.  CMS also informed Petitioner that it would not be permitted to operate a Nurse Aide Training and Competency Evaluation Program (NATCEP) for two years.  CMS Ex. 1 at 4.

On January 14, 2021, CMS issued a notice advising Petitioner that the state agency determined that Petitioner’s facility returned to substantial compliance effective December 30, 2020.  As a result, the DPNA was effective from December 19, 2020 through December 29, 2020, Petitioner was prohibited from operating a NATCEP for two years effective March 9, 2021, the termination of Petitioner’s provider agreement was rescinded, and the $225 per-day CMP extended from November 30, 2020 through December 29, 2020, for a total of $6,750.  This CMP, combined with the CMP imposed from November 24, 2020 through November 29, 2020, totaled $102,600.  CMS Ex. 2.

On March 15, 2021, Petitioner filed a request for hearing before an ALJ in which Petitioner disputed the findings of noncompliance and immediate jeopardy and requested that the CMP be eliminated or reduced.  Petitioner did not timely dispute the imposition of the DPNA.  The Civil Remedies Division acknowledged Petitioner’s hearing request and issued my Standing Prehearing Order (SPO).  The SPO established prehearing submission procedures and filing deadlines.

In response to the SPO, CMS filed a prehearing brief and ten proposed exhibits.  CMS also indicated that two state agency surveyors could be called as witnesses, but that CMS thought this case could be decided on the written record without their testimony.  Petitioner filed a prehearing exchange that included a brief and motion for summary judgment and 15 proposed exhibits, of which three (P. Exs. 1, 9-10) were written direct

**Page 6**

testimony from witnesses.4  Petitioner objected to three of CMS’s proposed exhibits and requested to cross-examine the surveyors that CMS listed in its submission.

CMS filed a response to Petitioner’s objections, a reply brief, a request to cross-examine Petitioner’s witnesses, and three supplemental proposed exhibits, including the written direct testimony of two witnesses (CMS Exs. 12-13).5  CMS again requested a decision on the written record.

Petitioner moved to supplement the record with an additional exhibit (P. Ex. 16), which Petitioner submitted in response to the written testimony of one of CMS’s witnesses. Petitioner also requested to cross-examine CMS’s witnesses and opposed CMS’s motion for a decision on the record.  Further, Petitioner objected to CMS Exhibit 11 and a portion of CMS Exhibit 13.

CMS filed a reply to Petitioner’s objections to CMS Exhibits 11 and 13 (a portion of the written testimony), and a motion to supplement the record with additional testimony from one of its witnesses (CMS Ex. 14) in response to Petitioner’s previous filings.

On October 22, 2021, I issued a Notice of Hearing in which I set January 24-25, 2022, as the dates for the hearing in this case.  I also denied Petitioner’s motion for summary judgment, denied CMS’s motion for a decision on the record, overruled all of Petitioner’s evidentiary objections, and granted both parties’ requests to supplement their prehearing submissions with Petitioner Exhibit 16 and CMS Exhibit 14. In addition, I admitted CMS Exhibits 1 through 14 and Petitioner Exhibits 1 through 16 into the record.

On November 30, 2021, CMS withdrew its request to cross-examine Petitioner’s witnesses.  As a result, I notified the parties the hearing would be limited to January 24, 2022).  On January 21, 2022, I granted CMS’s unopposed motion to continue the hearing

**Page 7**

and rescheduled the hearing for March 4, 2022.  On March 4, 2022, I held a hearing at which Petitioner cross-examined CMS’s witnesses, Captain Hyosim Seon-Spada (CMS Ex. 12) and Jessica Marcaccio, RN (CMS Exs. 13, 14).

In an April 1, 2022 Order, I notified the parties that the hearing transcript had been completed and set a post-hearing briefing schedule.6  On May 13, 2022, CMS filed a post-hearing brief (CMS Br.).  On June 17, 2022, Petitioner filed its post-hearing brief (P. Br.).  CMS filed a Reply Brief (CMS Reply) on July 12, 2022, and Petitioner filed a Sur-Reply on August 2, 2022 (P. Sur-Reply).

III.   Issues

1) Whether Petitioner was in substantial compliance with 42 C.F.R. § 483.80(a)(1)- (2).

2) If Petitioner was not in substantial compliance, whether CMS’s finding that Petitioner immediately jeopardized the health and safety of residents was clearly erroneous.

3) If Petitioner was not in substantial compliance with Medicare requirements, whether the amount and duration of the CMP that CMS imposed is appropriate under applicable statutory and regulatory factors.  42 U.S.C. § 1320a-7a(d); 42 C.F.R. § 488.438(f).

IV.    Findings of Fact, Conclusions of Law, and Analysis

**The Secretary declared COVID-19 to be a public health emergency on January 31, 2020, and, on March 9, 2020, the governor of Rhode Island declared a state of emergency due to COVID-19.**On January 31, 2020, the Secretary declared COVID-19 a public health emergency for the entire United States.  P. Ex. 6.

On March 9, 2020, the Governor of Rhode Island issued an Executive Order declaring a State of Emergency because:  the number of countries that were experiencing community transmission of COVID-19 continued to grow; community transmission in the United States had occurred in some states and was an immediate public health threat to the elderly and persons with underlying health conditions; cases of COVID-19 had been

**Page 8**

documented in Rhode Island; and Rhode Island needed to take additional measures to limit the spread of COVID-19.  P. Ex. 7.

**Petitioner’s COVID-19 Infection Control Plan**

**Petitioner created an ICP for COVID-19 in March 2020, which Petitioner revised in May 2020.  Consistent with guidelines from the Centers for Disease Control and Prevention (CDC), Petitioner’s ICP required Petitioner to screen all staff for a high temperature and COVID-19 symptoms upon entrance into the facility.  The ICP directed that, when a staff member had a temperature of 100° Fahrenheit or more or was feeling ill with respiratory symptoms, the staff member was not allowed in the facility.7  Further, if a staff member answered “yes” to any screening questions, then the staff member was not allowed into the facility until further evaluation and questioning took place.  As part of the screening process, the facility staff member conducting the screening was required to sign off on the screening form, indicating that the screened staff member was allowed to enter the facility.**On March 24, 2020, Petitioner implemented an ICP entitled, “COVID-19: General Screening and Health Care Personnel (HCP)/Visitor Response.” CMS Ex. 6.  This ICP, as revised on May 21, 2020, states that Petitioner will comply with the CDC and RIDOH guidelines for preventing the spread of COVID-19.  CMS Ex. 6 at 1, 3; P. Ex. 1 ¶ 6 (Petitioner’s ICP was “developed . . . to comport with [RIDOH] and [CDC] guidance regarding awareness and prevention of the spread of the COVID-19 virus.”).  Petitioner’s Administrator, Director of Nursing, and Medical Director signed the ICP on May 21, 2020.  CMS Ex. 6 at 3.

The ICP states that the “following steps must be taken to promote a culture of safety and to help ensure optimal surveillance of signs and symptoms of COVID-19,” including:

“Screening of all staff . . . is done upon entrance into the facility.”  CMS Ex. 6 at 1.
	The screening tool questionnaire, which the RIDOH updates as new evidence and information is learned, “includes symptom screening questions and quarantine screening questions; both sections must be completed with each and every person entering the facility.  There are no exceptions.”  CMS Ex. 6 at 1.
	“The required questions included on the COVID-19 Screening Tool Nursing Homes 5/20/2020 . . . must be filled out for anyone entering the facility.  The facility staff member conducting the screening will sign off on this form,**Page 9**

indicating if the person is allowed to enter the facility or not.” CMS Ex. 6 at 1; P. Ex. 1 ¶ 7.

“If the . . . employee (HCP) has a temperature (100 degrees Fahrenheit) or is feeling ill with respiratory symptoms, they cannot enter the facility.”  CMS Ex. 6 at 2.
	“If the . . . HCP answer “yes” to any of the screening questions, they will not be allowed in the facility until further evaluation and questioning.”  CMS Ex. 6 at 2.
	“If a HCP develops signs and symptoms of fever and/or respiratory issues, the employee is to put a mask on and leave work to self-isolate and monitor at home pending further work up.”  CMS Ex. 6 at 2.An October 26, 2020 Interoffice Memorandum to Petitioner’s staff on the subject of “Re-Education on the Process of Screening in Staff and Visitors” stated that staff screening includes the following:  “Another staff member is to take the temperature, do a visual observation, . . . and sign staff person in  . . . . Do not leave until you have been screened in by another staff member.”  CMS Ex. 6 at 4.

CDC guidance entitled “Preparing for COVID-19 in Nursing Homes,” updated June 25, 2020, directs facilities to “screen all HCP at the beginning of their shift for fever and symptoms of COVID-19.”  CMS Ex. 5 at 3.  Specifically, facilities should:

Actively take [HCPs’] temperature[s] and document absence of symptoms consistent with COVID-19. If they are ill, have them keep their cloth face covering or facemask on and leave the workplace.

CMS Ex. 5 at 3 (emphasis omitted).  CDC guidance states that the term HCP included “persons not directly involved in patient care, but who could be exposed to infectious agents that can be transmitted in the healthcare setting (e.g., clerical, dietary, environmental services, laundry, security, engineering and facilities management, administration, billing, and volunteer personnel).”  CMS Ex. 5 at 7.  CDC also advised:

Implement sick leave policies that are non-punitive, flexible, and consistent with public health policies that support HCP to stay home when ill.
	As part of routine practice, ask HCP (including consultant personnel and ancillary staff such as environmental and dietary services) to regularly monitor themselves for fever and symptoms consistent with COVID-19.**Page 10**

Remind HCP to stay home when they are ill.CMS Ex. 5 at 3.

**The CDC issued guidance on COVID-19 testing that advised nursing homes to create a plan for testing residents and HCP.  However, there is no documentation in the record showing that Petitioner’s ICP included COVID-19 testing.**The CDC COVID-19 guidance for SNFs, updated on June 25, 2020, advised facilities to create a plan for testing residents and HCP for COVID-19 as testing can detect current infections among residents and HCP in nursing homes.  CMS Ex. 5 at 3.  The CDC stated that the testing plan should align with state and federal requirements and address the following:  triggers for performing testing (e.g., resident or HCP with symptoms consistent with COVID-19, response to a resident or HCP with COVID-19 in the facility, or routine surveillance); access to reverse-transcriptase polymerase chain reaction (RT-PCR) tests and an arrangement with laboratories to process the tests; processes for and capacity to perform testing of all residents and HCP; and a procedure for addressing residents and HCP who are unable to be tested (e.g., maintaining transmission-based precautions until symptom-based criteria are met for a symptomatic resident who refuses testing). CMS Ex. 5 at 3.  The CDC advised that HCP with suspected COVID-19 should be prioritized for testing.  CMS Ex. 5 at 3.

On October 23, 2020, the CDC issued updated guidance entitled “Considerations for Use of SARS-COV-2 Antigen Testing in Nursing Homes.”  CMS Ex. 4.  According to the guidance for testing of symptomatic HCP, no confirmatory test is necessary if an antigen test is positive, and the HCP should be excluded from work.  CMS Ex. 4 at 2.  If the antigen test is presumptive negative, a RT-PCR test should be performed immediately (e.g., within 48 hours) and the HCP should be kept in transmission-based precautions or excluded from work until the RT-PCR test results are obtained. CMS Ex. 4 at 2.

Although the CDC issued guidance to facilities on creating a plan for testing residents and HCP, there is no evidence in the record that Petitioner developed a plan for COVID-19 testing or included COVID-19 testing in its ICP.

**The Statement of Deficiencies**

**The SOD issued by the state agency satisfactorily meets the regulatory requirement to be reasonably specific concerning the deficiency alleged.  Further, in its prehearing submission, CMS permissibly refined the factual basis for the deficiency in the SOD to conform with the evidence submitted by CMS in this case.  Petitioner received adequate notice of the factual and legal****Page 11**

**bases for the deficiency alleged in this case and had an opportunity, during this proceeding, to defend itself from those allegations.**

As mentioned earlier, the state agency conducted a COVID-19 Focused Infection Control Survey.  CMS Ex. 3 at 1.  The state agency issued a SOD in which it found Petitioner noncompliant with 42 C.F.R. § 483.80(a)(1), (2), (4), (e), (f) (Tag F-880) (Infection Prevention and Control) at a scope and severity level of “L” (i.e., isolated deficiency posing immediate jeopardy to resident health or safety).  CMS Ex. 3 at 1.

Petitioner asserts that the SOD is deficient because it fails to provide the “extent” of the deficiency.  Petitioner cites to a CMS guidance document for surveys under the Clinical Laboratories Improvement Amendments (CLIA) to establish that the SOD failed to note the “prevalence and frequency of a deficient practice and, when possible, is a numerical quantification of the deficient practice.”  Specifically, Petitioner argues that the SOD cites more limited facts as the basis for the § 483.80 deficiency than CMS does in its prehearing brief.  As a result, Petitioner posits that, “[a]lthough CMS attempted [in briefing] to provide a cure, that allegation remains deficient because it fails to provide the numerical qualification of the alleged deficient practice.”  P. Br. at 17 n.10.

In response, CMS points out that Petitioner cited a guidance document for CLIA surveys and not SNF surveys.  CMS Reply at 4.  Further, CMS asserts that guidance documents do not have the force of law and are not controlling.  CMS Reply at 4.  Finally, CMS argues that the SOD is a notice document that “is not designed to lay out every single detail in support of a finding that a violation has been committed.” *Cmty. Northview Care Ctr.*, DAB No. 2295 at 32-33 (2009) (citing *Pacific Regency Arvin*, DAB No. 1823 at 7 (2002); *Northern Montana Care Ctr.*, DAB No. 1930 (2004)).  Further, a SOD does not “rigidly frame the scope of the evidence to be admitted concerning any allegation relating to a cited deficiency, nor does it require formal amendment to allow additional supporting documents.”  *Cmty. Northview Care Ctr.*, DAB No. 2295 at 33 (quoting *Northern Montana Care Ctr.*, DAB No. 1930 at 26). The SOD may be amended or notice of additional evidence may be provided through prehearing record development without amending the SOD.  *Alden Town Manor Rehab. & Health Care Ctr.*, DAB No. 2054 at 18 (2006) (citing *Pacific Regency Arvin*, DAB No. 1823 at 9-10 (2002)).  CMS Reply at 3-5.

CMS’s arguments are correct.  *Cf*. Notice of Hearing at 4 (discussion of Petitioner’s objections to portions of the SOD).  There is no doubt that, in prehearing submissions, CMS may fill out additional details and submit evidence to support the allegations in the SOD.

Based on my review of regulatory requirements applicable to SODs and the record in this case, the SOD is sufficiently specific to place Petitioner on reasonable notice of the alleged deficiency.

**Page 12**

The Social Security Act (Act) indicates that documentation related to an SNF survey may include a SOD; however, the Act does not specify the requirements for the content of a SOD.  42 U.S.C. § 1395i-3(g)(5)(A)(i).  The Secretary’s regulations state that the findings of a state agency survey “must be adequately documented,” which includes a “description of the specific deficiencies. . . .”  42 C.F.R. § 488.18(a).  To achieve this goal, the Secretary instructed the state agency surveyors as follows:

Write the deficiency statement in terms specific enough to allow a reasonably knowledgeable person to understand the aspect(s) of the requirement(s) that is (are) not met. Do not delve into the facility’s policies and procedures to determine or speculate on the root cause of a deficiency, or sift through various alternatives in an effort to prescribe an acceptable remedy.  Indicate the data prefix tag and regulatory citation, followed by a summary of the deficiency and supporting findings.

42 C.F.R. § 488.110(i)(4).

In the present case, the SOD alleges Petitioner failed to maintain (i.e., implement fully) the facility’s ICP concerning employee screening for COVID-19 from August through November 2020.  The SOD stated the following:

[T]he facility failed to properly prevent and contain the potential spread and transmission of COVID-19 relative to its screening system failure that allowed staff to work while symptomatic for 55 sample staff reviewed (Staff ID’s A-X).

CMS Ex. 3 at 3.

The majority of the SOD provides a description of the specific factual findings of the survey that support the conclusion quoted above.  CMS Ex. 3 at 3-9.  A major focus of the SOD is on facility Staff member A.  The SOD alleged that, although Staff A reported multiple symptoms of COVID-19 on eight days between November 12 and November 24, 2020, staff performing the COVID-19 screenings permitted Staff A to enter the facility to work. The portion of the SOD involving Staff A concluded that Staff A “subsequently tested positive for COVID-19 on 11/24/2020, after working symptomatic on 8 separate occasions.”).  CMS Ex. 3 at 5-7.  The SOD then stated that an expanded sample review of staff screening records from August through November 24, 2020, revealed that, in addition to Staff A, Staff N, O, P, Q all signed themselves into the facility on November 21, 2020, without a screening staff member’s sign-off (Staff N also entering a second time without a sign-off on November 23, 2020).  CMS Ex. 3 at 7.  The

**Page 13**

SOD also documented that a number of staff screenings showed staff members entering for work with temperatures that were significantly lower than normal for human beings.  CMS Ex. 3 at 7-8.

Petitioner takes issue with the SOD’s primary conclusion (block quoted above) based on the facts alleged in the SOD and with CMS’s refinement of the facts to support the § 483.80 deficiency.  P. Br. at 17 n.10.  Based on my review, I conclude that the SOD sufficiently complies with the regulatory requirements for SODs by providing many factual findings to show the basis for a § 483.80 deficiency.  Further, based on my review of CMS’s prehearing submission, I conclude that CMS permissibly refined the allegations used to support a deficiency of § 483.80. The issues that CMS focuses on are at least generally implicated in the SOD because the SOD states that Petitioner’s noncompliance is due to facility staff allowing Staff A to work while symptomatic and that the facility failed to consistently implement its screening policy concerning a number of other employees.  CMS Ex. 3 at 3, 5-9.  Further, CMS clarified the facts supporting the deficiency in its submission. Therefore, Petitioner received sufficient notice of the allegations that it faces in this case and, with its prehearing and post-hearing submissions and cross-examination of CMS’s witnesses, had ample opportunity to respond to CMS.

**Screening of Staff A for COVID-19 Symptoms**

**On November 12, 2020, Staff A reported to work and indicated symptoms of muscle or body aches, fatigue, and a headache during screening to enter the facility.  Despite these symptoms, the facility screener signed off on Staff A’s responses and permitted Staff A to enter the facility to work.  For seven more days, through November 24, 2020, Staff A continued to report multiple COVID-19 symptoms; however, the facility allowed Staff A to continue working.  Staff A underwent COVID-19 testing on November 14, 20, and 21, and tested negative each time.  On November 24, Staff A tested positive for COVID-19 after reporting that Staff A’s spouse had contracted COVID-19.**On November 12, 2020, Petitioner’s screening questionnaire screened for the following signs and symptoms of COVID-19:  fever (temperature of 100°), cough, shortness of breath or difficulty breathing, muscle or body aches, sore throat, diarrhea, runny or stuffy nose, fatigue, headache, nausea or vomiting, and recent loss of taste or smell. CMS Ex. 7 at 1.  The questionnaire also asked whether:  anyone in the staff member’s household had been diagnosed with COVID-19; the staff member had been told to quarantine by a public authority; the staff member had been in close contact with someone who tested positive for COVID-19 without wearing a mask; and the staff member had traveled outside of Rhode Island.  CMS Ex. 7 at 1.  The questionnaire included spaces to record the staff member’s temperature and for another staff member’s signature indicating the screened staff member was allowed to enter the facility.  CMS Ex. 7 at 1.  The questionnaire stated that if a staff member answered “yes” to any symptom or quarantine

**Page 14**

questions, the staff member “should be excluded from the facility” and contact their healthcare provider or quarantine until 14 days passed since they were exposed to COVID-19.  CMS Ex. 7 at 1.

Staff A is a cook (i.e., dietary staff member) at the facility and works in the kitchen in the basement of the facility. The following is the chronology of events related to Staff A’s screening for COVID-19 symptoms:

On November 12, 2020, Staff A, who never entered resident care areas, reported to the facility for work and was screened for COVID-19 symptoms.  CMS Ex. 7 at 1; P. Ex. 1 ¶ 13; *see also* Tr. 36.  Staff A responded affirmatively to symptoms of muscle or body aches, fatigue, and headache.  CMS Ex. 7 at 1; P. Ex. 1 ¶ 14.  Another staff member signed off on Staff A’s responses and cleared her to enter the facility at 6:03 a.m.  CMS Ex. 7 at 1, 11.
	On November 14, 2020, Staff A reported for work and again reported experiencing muscle or body aches, fatigue, and headache.  CMS Ex. 7 at 1; P. Ex. 1 ¶ 14.  Although a second staff member did not sign off on Staff A entering the facility, Staff A began work at 5:52 a.m. and worked until 1:36 p.m.  CMS Ex. 7 at 1, 11.  Later that evening at 7:31 p.m., Staff A underwent a RT-PCR test and the results were negative.  CMS Ex. 7 at 8; P. Ex. 1 ¶ 14.
	Staff A presented to the facility for work on November 15, 2020, and reported muscle or body aches and fatigue.  CMS Ex. 7 at 1; P. Ex. 1 ¶ 15.  Staff A worked from 5:52 a.m. until 1:29 p.m.  CMS Ex. 7 at 1, 12.
	On November 16, Staff A reported feeling fatigue but was cleared by another staff member and worked from 5:52 a.m. to 1:39 p.m.  CMS Ex. 7 at 1, 12.
	Staff A underwent rapid antigen testing on November 20 because she was “[t]ired not feeling well,” but tested negative.  CMS Ex. 7 at 10; P. Ex. 1 ¶ 15.
	Staff A was cleared to work at 5:41 a.m. on November 21, despite reporting muscle or body aches, fatigue, and a headache.  CMS Ex. 7 at 1, 12; P. Ex. 1 ¶ 16.  At some point during the day, Staff A took a rapid antigen test because she was “[t]ired not feeling well,” but tested negative.  CMS Ex. 7 at 10; P. Ex. 1 ¶ 16.  At around 5:17 p.m., Staff A took a RT-PCR test, which was negative.  CMS Ex. 7 at 9; P. Ex. 1 ¶ 16.
	On November 22, Staff A presented to work and reported muscle or body aches, diarrhea, fatigue, and a headache.  CMS Ex. 7 at 1; P. Ex. 1 ¶ 17.  A staff member**Page 15**

signed off on Staff A’s entry to the facility and Staff A worked from 5:48 a.m. to 1:38 p.m. CMS Ex. 7 at 1, 13.

Staff A reported to work on November 23, and indicated she had muscle or body aches, fatigue, and shortness of breath or difficulty breathing.  CMS Ex. 7 at 1; P. Ex. 1 ¶ 17.  She was cleared to enter the facility and worked from 5:48 a.m. to 12:35 p.m.  CMS Ex. 7 at 13.
	On November 24, Staff A presented to work and reported muscle or body aches, fatigue, and a headache. CMS Ex. 7 at 1; P. Ex. 1 ¶ 18. Another staff member cleared her to enter the facility and Staff A worked from 5:48 a.m. to 1:37 p.m.  CMS Ex. 7 at 1, 13.  Later that day, at around 8:20 p.m., Staff A underwent a RT-PCR test because she was “[t]ired not feeling well.”  CMS Ex. 7 at 10; P. Ex. 1 ¶ 18; P. Ex. 11.
	On November 25, while awaiting the results of the November 24 RT-PCR test, Staff A informed Petitioner’s Administrator that her spouse tested positive for COVID-19.  P. Ex. 1 ¶ 19.  At the Administrator’s request, Staff A immediately went to the facility to undergo a rapid antigen test.  P. Ex. 1 ¶ 19.  Staff A tested positive and was sent home.  P. Ex. 1 ¶ 19; P. Ex. 9 ¶ 18.  Later that day, the facility received the positive test result from Staff A’s November 24 RT-PCR test.  P. Ex. 1 ¶ 19; P. Ex. 9 ¶ 17; P. Ex. 11.Petitioner’s Administrator testified she was in “constant contact with Staff A during and prior to each instance in which Staff A provided an affirmative response on the screening questionnaire.”  P. Ex. 1 ¶ 21.  The Administrator stated she “repeatedly questioned and evaluated Staff A and – prior to permitting Staff A to work – determined that Staff A’s symptoms were attributable to . . . Staff A’s underlying chronic respiratory conditions and fatigue from work and stress during the pandemic.”  P. Ex. 1 ¶ 21.  Petitioner submitted no documentation to substantiate the Administrator’s alleged evaluations or Staff A’s alleged underlying medical condition.

**Petitioner was not in substantial compliance with 42 U.S.C. § 1395i-3(d) and 42 C.F.R. § 483.80(a)(1)-(2) because, from November 12 to 24, 2020, it failed to maintain/implement its ICP concerning the screening of Staff A for COVID-19 symptoms.  Petitioner’s noncompliance had the potential to cause more than minimal harm to its residents.**The Act states that an SNF must:

Establish and maintain an infection control program designed to provide a safe, sanitary, and comfortable environment in

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which residents reside and to help prevent the development and transmission of disease and infection.

42 U.S.C. § 1395i-3(d)(3)(A); *see also* 42 C.F.R. § 483.80 (prefatory text).  Consistent with the Act, the Secretary’s implementing regulations require facilities to establish and maintain an ICP that includes, among other things, 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.”  42 C.F.R. § 483.80(a)(1).

In light of the statutory and regulatory injunction to establish *and maintain*an ICP with the stated focus on achieving health outcomes (*e.g.*, the prevention of the transmission of disease and infection), 42 U.S.C. § 1395i-3(d)(3)(A) and 42 C.F.R. § 483.80 require SNFs to do more than merely adopt an ICP as its internal policy, but rather require SNFs to implement the ICP’s prescribed precautions.8  *Golden Living Ctr. – Superior*, DAB No. 2768 at 7 (2017) (citing *Heritage House of Marshall Health & Rehab. Ctr.*, DAB No. 2566 at 12 (2014)).  A facility is not in substantial compliance with participation requirements when it fails to follow standard precautions and isolation control procedures specified in its internal ICP. *Heritage House of Marshall Health & Rehab. Ctr.*, DAB No. 2566 at 13.

CMS argues Petitioner did not comply with its ICP by allowing Staff A to enter the facility to work on eight days when she reported having COVID-19 symptoms.  CMS Br. at 19.  CMS points to Petitioner’s screening policy, which states that staff members answering “yes” to any screening questions would not be allowed to enter the facility. CMS Br. at 19 (citing CMS Ex. 6 at 2).

Petitioner asserts that it followed its ICP with respect to Staff A because, on each occasion that Staff A answered “yes” to any of the screening questions, Staff A contacted the Administrator.  Petitioner argues that permitting Staff A to work after affirmative responses to COVID-19 symptoms does not violate 42 C.F.R. § 483.80 because the Administrator determined the symptoms were attributable to known causes other than COVID-19.  Petitioner also claims that the Administrator’s evaluation of Staff A was

**Page 17**

done in addition to routine testing of Staff A.  P. Br. at 20 (citing P. Ex. 1 ¶ 14-18, 21).  As Petitioner points out, the ICP states that, if an HCP answers “yes” to any of the screening questions, they will not be allowed to enter the facility until “further evaluation and questioning” is completed.  P. Br. at 20 (citing CMS Ex. 6 at 2).

Petitioner submitted testimony from the Administer to support Petitioner’s claims that Staff A was properly evaluated each time Staff A indicated COVID-19 symptoms during screening.  P. Ex. 1 ¶ 21.  The Administrator is a registered nurse who holds two nursing degrees.  P. Ex. 1 ¶ 2; P. Ex. 1 at 9.  Generally, the Administrator testified to repeatedly questioning Staff A and determining that Staff A’s symptoms were attributable to Staff A’s underlying alleged chronic respiratory conditions and fatigue from work and stress during the pandemic.  P. Ex. 1 ¶ 21.

Petitioner’s also provided expert testimony from Dr. Katz to show that the Administrator appropriately evaluated Staff A:

Staff Member “A” was tested for COVID-19 repeatedly during the timeframe of the alleged positive symptom screening.  She/he had a known comorbid condition which led to a positive symptoms screen, of which the Administrator was aware, and there is no evidence that she transmitted [COVID-19] to any other staff members or residents.  In my professional opinion, it was appropriate for the Administrator to evaluate Staff A’s symptoms to determine whether they were attributable to another condition.

P. Ex. 10 ¶ 14.

I do not give weight to the testimony from either witness concerning the alleged evaluations of Staff A.  Neither the Administrator nor Dr. Katz provided any details as to Staff A’s alleged underlying conditions that caused Staff A to have symptoms of COVID-19.  Further, while the Administrator’s testimony delineates each day when Staff A presented with COVID-19 symptoms during screening (P. Ex. 1 ¶¶ 14-19), the Administrator did not include, with each of those dates, any specific information as to each evaluation made of Staff A.  Rather, the Administrator’s testimony about the alleged evaluations appeared in a single catch-all statement that lacks specific information.  P. Ex. 1 ¶ 21.  Significantly, this relatively vague testimony, which fails to identify Staff A’s alleged medical conditions that produced COVID-like symptoms, is not supported by any documentation of those evaluations.9  *See* CMS Ex. 12 ¶ 8(a)(i).  Dr. Katz’s brief

**Page 18**

testimony is even vaguer and does not indicate that she reviewed documentation of the evaluations.  While Petitioner’s ICP allows further evaluation and questioning when determining whether to allow a staff member into the facility when the staff member reports COVID-19 symptoms, there must be evidence for me to find that those evaluations took place.  Without documentation, there is no way for me to confirm such evaluations occurred each time Staff A was admitted with symptoms or to review whether the Administrator’s evaluation was reasonable.  *See*CMS Ex. 13 ¶ 4(a)(i).  Therefore, I cannot give any weight to bare testimony that the Administrator properly evaluated Staff A each time Staff A presented to the facility with COVID-19 symptoms.

As Dr. Katz and the Administrator both testified, Petitioner did test Staff A at various times for COVID-19 during the November 12-25 time period.  However, the testing performed on Staff A was not done pursuant to Petitioner’s ICP (which does not provide for testing) and appears to have been ad hoc in nature.

By November 2020, the CDC had already established testing as a core practice for management and prevention of COVID-19 in nursing homes.  CMS Ex. 5 at 2-3; *see* CMS Ex. 4.  Although the CDC issued guidance to facilities on creating a plan for testing residents and HCP, there is no evidence in the record that Petitioner developed a plan for COVID-19 testing or included COVID-19 testing in its ICP.  This is particularly difficult to fathom because the facility had a COVID-19 outbreak beginning October 21, 2020, and on October 23, Rhode Island documented 470 new positive COVID-19 cases, a record high daily positive rate.  P. Ex. 1 ¶¶ 9, 10.  October 23, 2020 is also the date the CDC updated its guidance for COVID-19 testing at SNFs.  CMS Ex. 4. Despite this, Petitioner did not update its ICP to include testing.10

**Page 19**

By November 12, 2020, while some residents were still under quarantine from the October 21 outbreak in the facility, Staff A was allowed to work in the facility despite reporting COVID-19 symptoms during screening.  Yet, Petitioner did not test Staff A on November 12 to ensure that Staff A did not bring another case of COVID-19 into the facility.  *See* P. Ex. 10 (Dr. Katz testifying that consistent testing, in combination with personal protective equipment, is the best method to protect SNFs from COVID-19).

Contrary to Dr. Katz’s testimony that Staff A was tested repeatedly, the record shows Petitioner did not consistently test Staff A even though she reported COVID-19 symptoms every day she presented to work from November 12 through 24, 2020.  Staff A reported symptoms on November 12 but did not undergo testing until late on November 14.  CMS Ex. 7 at 1, 8; P. Ex. 1 ¶ 14. Although Staff A tested negative on November 14, Staff A continued to report symptoms on November 15 and 16, but did not undergo any testing.  CMS Ex. 7 at 1, 12.  Staff A still had symptoms on November 21, but again tested negative.  CMS Ex. 7 at 1, 9, 10, 12; P. Ex. 1 ¶ 16. On November 22, Staff A’s condition appeared to worsen as she reported a new symptom of diarrhea, yet she did not undergo another test until November 24, which eventually came back positive for COVID-19.  CMS Ex. 7 at 1, 10; P. Ex. 1 ¶¶ 17, 18.  Moreover, although RT-PCR tests are more accurate than rapid antigen tests (CMS Ex. 4 at 1; Tr. 43), Staff A only completed RT-PCR tests on November 14, 21, and 24. P. Ex. 1 ¶¶ 14, 16; P. Ex. 11. Captain Seon-Spada testified that rapid tests are “tricky” because they are not accurate enough to capture all viruses and would not capture low levels of a virus.  Tr. 52; *see also* CMS Ex. 7 at 8-9 (“[R]esults do not rule out [COVID-19] infection and should not be used as the sole basis for clinical decisions.”).

While Petitioner tested Staff A on various occasions, this alone is insufficient to show compliance with the ICP.  This is especially true for November 12 and 14, when Petitioner allowed Staff A to work each day without testing.  And this is also true for November 22, when Staff A reported a new symptom and testing was not done until November 24, which showed Staff A was positive for COVID-19.

Finally, Petitioner argues that there is no likelihood that Staff A could have infected anyone at the facility with COVID-19 because Staff A worked in the kitchen in the basement and did not have resident contact. P. Br. at 30; Tr. 36, 53, 54.  Petitioner explains food is delivered to resident care units via a dumb waiter.  Nurses then distributed the food directly to residents, who ate meals in their rooms. P. Br. at 30; Tr. 36-37.  Further, Dr. Katz testified that COVID-19 is not transmitted through food and, because Staff A did not have any resident contact, “the likelihood of any transmission of COVID-19 to residents by Staff A was highly improbable and would not have occurred through food preparation.”  Dr. Katz also noted that there is no evidence that Staff A practiced poor hand hygiene.  P. Ex. 10 ¶ 15.

**Page 20**

Although COVID-19 may not be transmitted by food and Staff A allegedly never had contact with residents, it does not follow that permitting a dietary staff member with multiple COVID-19 symptoms to enter the facility for many days did not present the potential for harm or the likelihood for serious harm.  Captain Seon-Spada agreed that, although the CDC recommended hand hygiene, COVID-19 is not transmitted through food.  Tr. 45. However, Captain Seon-Spada testified:

[B]ased on my clinical experience and review of relevant medical literature, Staff A had the potential to transmit COVID-19 to any staff that she came into contact with and these staff members then had the potential to transmit COVID-19 to residents.  Thus, given the high transmission rate of COVID-19, particularly in the vulnerable population cared for at Petitioner’s facility, Petitioner’s residents were in immediate jeopardy when Petitioner permitted Staff A to work while symptomatic on eight occasions.

CMS Ex. 12 ¶ 8(a)(ii).  She also testified to the following at the hearing:

There’s no 100 percent that [Staff A] had no contact at all with the residents.  And also staff to staff, and sometimes they take a break.  Lunchrooms, what not.  And absolutely there’s a risk.  That’s why it’s very critical that having strong screening system in place, and make sure that people are wearing [personal protective equipment] correctly, and then testing, the COVID testing, try to capture if there’s anything that we can capture so that we can prevent infection coming into the facility to save the residents because it comes in.

Tr. 53.  Jessica Marcaccio, RN, testified similarly:

In her position as a cook, Staff A risked transmitting COVID-19 to the staff that she encountered throughout her day, including the staff that entered the kitchen to obtain food and drinks for residents. Given the high transmissibility of COVID-19, since it was possible that Staff A would transmit COVID-19 to another staff member who had direct contact with residents, the potential risk to residents was significant.

CMS Ex. 13 ¶ 4(a)(iii).

There is no doubt that COVID-19 was most likely to spread through respiratory droplets when someone coughs, sneezes, or talks; however, the CDC also found that “it is possible

**Page 21**

that a person can get COVID-19 by touching a surface or object, including food or food packaging, that has the virus on it and then touching their own mouth, nose, or possibly their eyes.”  P. Ex. 14 at 1.  CDC guidance also included dietary staff under the term HCP so that all general COVID-19 infection prevention recommendations would apply to food preparers as it would to those directly providing health care services in an SNF.  *See* CMS Ex. 5 at 6-7; *see also* CMS Ex. 5 at 3 (emphasizing that HCP includes “ancillary staff such as . . . dietary services.”).

As Captain Seon-Spada and Jessica Marcaccio, RN testified, Staff A had the potential to spread COVID-19 to other staff, such as those in the kitchen and those whom she encountered while waiting to be screened or while walking through the facility to and from the kitchen.  Those staff could have direct contact with residents or could spread COVID-19 to staff who had direct contact with residents.  Further, Staff A later reported a new symptom of diarrhea, which should have given additional pause as to whether cooking staff be permitted to work. *See* CMS Ex. 9 (CDC guidance explaining that “[f]ood eaten at restaurants sometimes makes people sick because food workers handled the food when they were sick with vomiting or diarrhea. Germs from sick food workers can get onto food if workers do not wash their hands properly and then touch food with their bare hands.”).

Even if Staff A did not have direct contact with residents, or any other staff, Petitioner’s ICP does not include an exception for kitchen staff. Staff A was subject to Petitioner’s ICP because the ICP explicitly called for “[s]creening of *all* staff . . . .”  CMS Ex. 6 at 1 (emphasis added).  As such, Staff A should have been turned away from the facility on at least November 12, 14, and 22 (and possibly on other dates) under the ICP.  Given the highly contagious nature of COVID-19 and the vulnerable SNF population, it was imperative the facility took all measures to prevent the introduction and transmission of COVID-19 into the facility. As Captain Seon-Spada testified, “it only takes once, one person, one time to bring the potential COVID infection into the facility.” Tr. 30.  If Staff A transmitted COVID-19 to others, it could have started a new outbreak with adverse consequences for residents at high risk of being affected by respiratory pathogens such as COVID-19.  *See* CMS Ex. 5 at 1.  Petitioner’s failure to fully implement its ICP with respect to Staff A presented a situation involving the risk for more than minimal harm.  Therefore, Petitioner was not in substantial compliance with 42 C.F.R. § 483.80(a)(1)-(2).

**Other Allegations Concerning Staff Screening**

**Petitioner was also not in substantial compliance with 42 C.F.R. § 483.80(a)(1)-(2) because staff did not comply with Petitioner’s ICP requiring a second staff member to sign off on the screening form for an employee presenting to work. Screening logs showed that on multiple occasions from September through November 2020, staff cleared themselves****Page 22**

**for work without having a second staff member sign off on their screening questionnaires.  Given the deadly and contagious nature of COVID-19 in the SNF setting, these violations of the ICP posed the risk of causing more than minimal harm to residents.**

As alleged in the SOD and shown in facility documentation, on September 19, 2020, Staff A signed herself in without a second staff verification.  CMS Ex. 3 at 7; CMS Ex. 7 at 4.  Additionally, Staff O, P, and Q signed themselves into work on November 21, 2020, and Staff N signed himself into work on November 21 and 23. CMS Ex. 3 at 7; CMS Ex. 7 at 15-17, 28-31.

CMS argues Petitioner also failed to maintain its ICP because, on at least six occasions, staff cleared themselves to work without being signed off by a second staff member.  CMS Br. at 22.  Petitioner asserts those instances cannot constitute noncompliance because the record does not contain any evidence that these “miniscule technical errors were connected to potential resident harm.”  P. Br. at 23-25.  Petitioner’s Business Operations Associate testified that the six occasions CMS identified as staff entering the facility without obtaining the signature of a second staff member (September 19, 2020, November 21, 2020, and November 23, 2020) represent the only occasions, out of 3,900 screenings, in which staff entered the facility without the signature of a second employee.  P. Ex. 9 ¶¶ 13-15; *see* Tr. 29.  Petitioner also contends that even though a second staff member did not verify the employees’ responses, the employees had responded to all the questions regarding the “required symptoms.”  Tr. 32.

Petitioner’s ICP requires the facility staff member conducting the screening to sign off on the form, indicating whether the person is allowed to enter the facility.  CMS Ex. 6 at 1.  Petitioner’s October 26, 2020 re-education document provides that the staff who is screening the incoming employees to the facility must take the temperature of the employees and “do a visual observation.”  CMS Ex. 6 at 4.  It admonishes employees:  “Do not leave until you have been screened in by another staff member.”  CMS Ex. 6 at 4.

Petitioner’s ICP is consistent with the RIDOH recommended screening tool sheets, which provide for a “Staff signature line” and a place where that staff member checks whether the employee being screened had been “Cleared to enter facility.”  CMS Ex. 11 at 1-3; P. Ex. 12; P. Ex. 13 at 4. It is also consistent with CDC guidance, which recommends that SNFs “[s]creen all HCP at the beginning of their shift for fever and symptoms of COVID-19.”  CMS Ex. 5 at 3.  It does not indicate that HCP ought to self-screen when entering an SNF.

Captain Seon-Spada testified about the importance of having another staff member, ideally a clinical staff member, verify employees’ responses so that questions can be posed to an employee presenting with COVID-19 symptoms.  Tr. 47-48.  Captain Seon-

**Page 23**

Spada explained that a clinical staff member would have the medical training to identify any risks or further examine any employee who reported positive answers.  Tr. 48. She also testified that the lack of signatures means the employees’ answers were not validated.  Tr. 32.  Even if employees responded “no” to all symptoms, as staff members A, N, O, P, and Q did in this case, having another staff member conduct the temperature check and make visual observations serves an important purpose of helping to ensure that staff who may think they are well, but are not, do not get admitted into the facility where COVID-19 could eventually be spread to residents.

Moreover, while the six instances represent only a small percentage of employee screenings during the period at issue, again, it only takes one instance to introduce a potential COVID-19 infection into the facility.  *See*Tr. 30; CMS Ex. 13 ¶ 4(b)(v).

Having just experienced a COVID-19 outbreak, it was essential for Petitioner to fully comply with all provisions of the ICP to prevent the development and spread of COVID-19, a highly contagious disease with the potential for severe consequences for elderly and vulnerable SNF residents. Petitioner’s ICP required all employees to be screened in by another staff member, and Petitioner acknowledged the importance of this provision when it issued a re-education document to reinforce this requirement to staff.  Therefore, Petitioner was not in substantial compliance with 42 C.F.R. § 483.80(a)(1)-(2).

**Petitioner was also not in substantial compliance with 42 C.F.R. § 483.80(a)(1)-(2) because it did not ensure temperature screenings of staff were accurate.  From August through November 2020, there were 22 instances of staff reporting temperatures below 95°, a temperature indicating hypothermia.  Additionally, there were 78 other instances where staff reported temperatures below the normal human body temperature range of 97° to 99°.  Petitioner’s failure to verify the accuracy of staff temperatures that were outside the range of normal human body temperature constituted a violation of its ICP because staff were admitted without knowing what their true body temperature was.**The SOD stated that staff screening records showed unusually low body temperatures on dates in August through November 2020 for a variety of staff members.  CMS Ex. 3 at 7-8.  According to CDC guidance on hypothermia and frostbite, a body temperature below 95° requires immediate medical attention.  CMS Ex. 8 at 2.  During screening, on 22 occasions, staff reported temperatures of between 89° to 94.8°. CMS Ex. 7 at 18, 19, 21, 22, 24, 28, 31; CMS Ex. 13 ¶ 4(b)(iv).  Several staff also reported temperatures that were just above 95° (95.1, 95.3, 95.4, 95.5, 95.6, 95.7).  CMS Ex. 7 at 19, 21, 22, 24, 25, 27, 28, 31.  Notably, Petitioner’s records show that Staff A had a temperature of 95.3° on November 21 and 95.5° on November 22, dates when she reported multiple COVID-19 symptoms and was still allowed to work.  CMS Ex. 7 at 22, 24.

**Page 24**

CMS argues Petitioner was not in substantial compliance with 42 C.F.R. § 483.80(a)(1)-(2) because it failed to confirm the accuracy of abnormally low staff temperature readings on 22 occasions between August 1 and November 23, 2020.  CMS Br. at 24.  Captain Seon-Spada testified that normal human body temperature should be between 97° and 99° and a person with a temperature of 89° “should not be standing and talking.”  Tr. 33. While Captain Seon-Spada and Ms. Marcaccio did not believe the staff members were hypothermic, they testified the low temperatures indicated the thermometer was incorrectly calibrated and clinical staff should have been asking whether the thermometer was accurate. CMS Ex. 12 ¶ 8(c)(iii); CMS Ex. 13 ¶ 4(b)(iv); Tr. 33, 48.  Captain Seon-Spada further testified that a facility needs to have a way of ensuring that the thermometer used to screen staff is accurate.  Tr. 48.  If a person has a temperature below 97° or higher than 99°, particularly below 97°, staff should ask whether the thermometer is working.  Tr. 48.  If a thermometer is reading low, then it would miss someone who has a high temperature who may be infectious.  Tr. 49.

Petitioner argues that the 22 occasions represented only 0.56 percent of the staff temperatures screened.  P. Br. at 16, 24.  Petitioner claims that it was successful in adhering to the regulation and its ICP because 99.44% of staff members recorded temperatures of 95° or higher upon entering the facility.  P. Br. at 24-25; P. Ex. 9 ¶ 11.  Petitioner further asserts that on none of the 22 occasions did staff members answer affirmatively for COVID-19 symptoms.  P. Br. at 25; P. Ex. 9 ¶ 12; *see* CMS Ex. 7 at 19-31. Petitioner again argues that these allegations are so miniscule that they cannot constitute violations of its ICP. P. Br. at 22.

The regulation requires the facility to establish and maintain an ICP that includes a “system for preventing, identifying, reporting, investigating, and controlling infections and communicable diseases.”  42 C.F.R. § 483.80(a)(1).  Petitioner established temperature as one method of identifying, preventing, and controlling infections and communicable diseases, yet it did not maintain its ICP when employees reported abnormally low temperatures.  As Captain Seon-Spada testified, a person’s temperature is objective information the facility can collect.  Tr. 49. If the thermometer is not calibrated correctly and reporting temperatures that are lower than a person’s actual temperature, the facility could miss a staff member with a temperature of 100° or higher, which could indicate the staff member may be positive for COVID-19.  Tr. 49.

Further, a small percentage of staff members reporting temperatures below 95° does not mean that the remaining temperatures of other staff members were accurate.  Rather, it may signify that other staff temperatures were also inaccurate.  Given that normal human body temperature is between 97° to 99°, staff members reporting temperatures of 97° or 98° with an incorrectly calibrated thermometer could have actually had temperatures over 100°. Additionally, while there were only 22 temperatures below 95°, there were 78 instances of temperatures between 95° and 97°, which should have also alerted screening

**Page 25**

staff that the thermometer may not have been accurate.  CMS Ex. 7 at 19, 21, 22, 24, 25, 27, 28, 31.

In addition, the fact that on none of the 22 occasions did staff members answer affirmatively for COVID-19 symptoms is irrelevant.  Fever is a known COVID-19 symptom.  CMS Ex. 5 at 3, 5-6; CMS Ex. 11 at 1-3; CMS Ex. 12 ¶ (8)(c)(iii); CMS Ex. 13 ¶ 4(b)(iv); P. Ex. 12.  Petitioner’s ICP states that a staff member with a fever alone cannot enter the facility.  CMS Ex. 6 at 2 (“If the . . . employee (HCP) has a temperature (100 degrees Fahrenheit) or is feeling ill with respiratory symptoms, they cannot enter the facility.”).  Petitioner’s failure to ensure its thermometer was accurate meant that Petitioner failed to properly implement the ICP and could have resulted in a staff member with COVID-19 potentially spreading COVID-19 throughout the facility.

Petitioner violated its ICP because obtaining and recording accurate staff temperatures is essential for preventing, identifying, and controlling the spread of COVID-19 among vulnerable residents at high risk for contracting COVID-19 and suffering adverse consequences from the disease.  *See* CMS Ex. 5 at 1.  Therefore, Petitioner was not in substantial compliance with 42 C.F.R. § 483.80(a)(1)-(2).

**CMS alleges Petitioner failed to screen staff for all symptoms of COVID-19 on October 25 and 26, 2020.  However, on August 13, 2020, the RIDOH emailed an updated screening tool to SNFs in Rhode Island.  Relying on RIDOH’s screening tool, Petitioner promptly removed four symptoms from its screening process.  On October 26, 2020, RIDOH sent SNFs another updated screening tool that again added the four previously removed symptoms.  Petitioner immediately added back the four symptoms it had removed from the staff screening process in August to comply with the October 26 update.  Petitioner’s timely compliance with RIDOH updates to the screening tool do not provide additional support for the deficiency at 42 C.F.R. § 483.80 because Petitioner’s actions adhered to the ICP.**CMS alleges that some of Petitioner’s staff were allowed to enter the facility despite failing to answer screening questions related to four potential COVID-19 symptoms on October 25 and 26, 2020.  CMS Br. at 23; CMS Ex. 12 ¶ 8(c)(ii); CMS Ex. 13 ¶ 4(b)(iii). On those two days, 15 separate staff members were cleared to enter the facility to work on 17 occasions even though they failed to answer screening questions regarding the symptoms of fatigue, headache, nausea or vomiting, and recent loss of taste or smell.  CMS Ex. 7 at 25-26.  The SOD also documented various failures to obtain responses to screening questions in August and October 2020.  CMS Ex. 3 at 8.  In response, Petitioner asserts it relied on the RIDOH’s recommendations for screening of COVID-19 symptoms.  P. Br. at 15, 27.

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The record contains a RIDOH COVID-19 Screening Tool form that appears to have been adopted on July 3, 2020.  The document states that it is the “[r]ecommended tool to screen employees . . . for symptoms of COVID-19.”  The screening tool first indicates that a screener should ask if the employee “had any of the following symptoms in the past three days that are not explained by allergies or a non-infectious cause?”  The list includes cough, shortness of breath or difficulty breathing, fever or chills, muscle or body aches, sore throat, headache, nausea or vomiting, diarrhea, runny nose or stuffy nose, fatigue, or recent loss of taste or smell.  Questions concerning “Risk Factors” included whether the employee had been in close contact with anyone with COVID-19 or symptoms of COVID-19 in the past 14 days and whether the employee had traveled outside the 50 United States in the past 14 days.  The Screening Tool warned in capital letters and red colored text:  “If you have answered ‘Yes’ to any of the questions above, and you cannot explain these symptoms by known allergies or non-infectious illnesses, then you cannot enter this building for the safety of others.” CMS Ex. 11 at 1-3.

On August 13, 2020, RIDOH sent Rhode Island SNFs an erroneously updated screening tool.  The screening tool eliminated screening questions for fatigue, headache, nausea or vomiting, and recent loss of taste or smell. P. Ex. 9 ¶ 7; P. Ex. 12; P. Ex. 16; CMS Ex. 14 ¶ 3; Tr. 74-76. RIDOH did not provide another updated screening tool until October 26, 2020, at 9:03 a.m.  P. Ex. 9 ¶ 8; Tr. 79-81.

Ms. Marcaccio testified that RIDOH required SNFs to check for all COVID-19 symptoms from August through October 2020.  CMS Ex. 13 ¶ 4(b)(iii).  She explained:

The screening questions regarding fatigue, headache, nausea or vomiting, and recent loss of taste or smell appeared on the screening documentation that Petitioner produced to the surveyor during the survey. Given that Petitioner’s policy required staff to answer all screening questions, Petitioner was required to ensure that its staff answered the questions before entering.  Additionally, I have consulted with the appropriate state website development staff, and, I confirm that, to the best of my knowledge, these screening questions were consistent with the screening questions made publically [sic] available on Rhode Island’s reopening website beginning in July 2020 and continuing through October 2020, thus Petitioner should have been aware that RIDOH expected Petitioner to have its staff to report the presence or absence of these symptoms prior to entry.  Finally, these screening questions were consistent with CDC guidance throughout the relevant time period.

CMS Ex. 13 ¶ 4(b)(iii); *see also* Tr. 74.

**Page 27**

In supplemental written direct testimony, Ms. Marcaccio confirmed RIDOH sent the August 13, 2020 email to SNFs with a screening tool that failed to include screening for symptoms of fatigue, headache, nausea or vomiting, or recent loss of taste or smell.  She noted the screening tool was outdated as it was the first screening tool the RIDOH developed for SNFs in Spring 2020.  RIDOH continued revising the screening tool to reflect updated COVID-19 guidance and the July 2020 version (CMS Ex. 11 at 1-3), which was publicly available on the RIDOH website, accurately reflected the COVID-19 symptoms for screening.CMS Ex. 14 ¶ 3; *see also* Tr. 74-76.Ms. Marcaccio explained during the hearing that she did not know why the screening tool included with the August 13 email eliminated some symptoms and suggested it could have been an error.  Tr. 82.

Ms. Marcaccio testified that, despite RIDOH’s mistake in sending an incorrect screening tool around to SNFs in August 2020, Petitioner ought not to have followed it because the symptoms to be screened for were not the same as CDC and RIDOH guidance documents. She noted CDC guidelines recommended SNFs screen staff for COVID-19 symptoms, which included fatigue, headache, nausea or vomiting, and recent loss of taste and smell.  The RIDOH made the correct screening tool (CMS Ex. 11 at 1-3) publicly available on its website beginning July 2020 and continuing through October 2020.  Ms. Marcaccio asserted that Petitioner’s ICP required compliance with CDC and RIDOH guidance and that by following the screening tool issued by RIDOH in August 2020, Petitioner failed to follow its ICP.  CMS Ex. 14 ¶ 4.

CMS contends that, even though RIDOH sent the wrong version of the screening tool in August 2020, the correct version was available online and SNFs were not required to use the RIDOH screening tool. CMS Br. at 23.  CMS asserts other resources that included fatigue, headache, nausea or vomiting, and recent loss of taste or smell as screening symptoms were also available to Petitioner.  CMS Br. at 23-24.  CMS also argues that as early as May 13, 2020, the CDC identified fatigue, headache, nausea or vomiting, and recent loss of taste or smell as symptoms of COVID-19. CMS Br. at 23 (citing CMS Ex. 11 at 4).

Petitioner claims staff did not respond to screening questions regarding fatigue, headache, nausea or vomiting, and recent loss of taste or smell from August 14, 2020, through midday on October 26, 2020, because those symptoms were not included on the screening tool RIDOH provided on August 13, 2020. P. Br. at 15.  Petitioner asserts RIDOH modified the COVID-19 Screening Tool on August 14, 2020,11 and the symptom screening questions included cough, shortness of breath or difficulty breathing, fever or

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chills, body aches, sore throat, diarrhea, and runny nose or stuffy nose, but no longer included fatigue, headache, nausea or vomiting, and recent loss of taste or smell. P. Ex. 9 ¶ 7; P. Ex. 12; P. Ex. 16; CMS Ex. 14 ¶ 3; Tr. 74-76. Mr. Blundo, Petitioner’s Business Operations Associate, testified consistently about the ICP that when Petitioner received the screening tool sent by RIDOH on August 13, 2020, which no longer included checking for symptoms of fatigue, headache, nausea or vomiting, and recent loss of taste and smell, Petitioner removed those symptoms from the staff screening process.  P. Ex. 9 ¶¶ 7, 9.

RIDOH did not provide an updated screening tool until October 26, 2020, at 9:03 a.m., which added back screening questions for fatigue, headache, nausea or vomiting, and recent loss of taste or smell.  P. Ex. 9 ¶ 8; P. Ex. 13.  On October 26, 2020, when RIDOH sent an email stating “the attached file is the updated screening tool for nursing homes and assisted living residences,” Petitioner immediately reinstated screening for the symptoms that had been removed based on the August 13, 2020 email.  P. Ex. 9 ¶ 8; P. Ex. 13; *see also* Tr. 83 (the October 26, 2020 updated screening tool was the next update following the August 13, 2020 email); CMS Ex. 7 at 25-26.

I disagree with CMS’s argument that Petitioner needed to disregard RIDOH’s screening tool recommendations in order to remain in compliance with Petitioner’s ICP.  Looking at the specific facts in this case, it is significant that RIDOH’s Chief Program Evaluator in RIDOH’s Center for Health Facilities Regulation sent an email out to a large number of facilities and stated: “[A]ttached is the most current screening tool.”  P. Ex. 16 at 1-2; Tr. 75.  While other resources may have been available to Petitioner, or, as Ms. Marcaccio testified, RIDOH did not require SNFs to use the RIDOH screening tool (Tr. 82), it was reasonable for the facility to use the RIDOH screening tool and accept it as the most current version.  Tr. 76-77 (Ms. Marcaccio testifying that SNFs should be able to reasonably rely on information provided by RIDOH).  Further, Petitioner’s ICP specifically references a May 20, 2020 “COVID-19 Screening Tool Nursing Homes” and states that RIDOH “updates the screening tool questionnaire as new evidence and information is learned.”  CMS Ex. 6 at 1.  Therefore, following the most recent screening tool issued by RIDOH conformed to Petitioner’s ICP.  And CMS never alleged that Petitioner’s ICP was inadequate.

Petitioner’s counsel questioned Captain Seon-Spada and Ms. Marcaccio concerning CMS Exhibit 7, which bears out Mr. Blundo’s testimony that Petitioner promptly changed the symptom screening questions based on the emails from RIDOH.  Tr. 24-28, 78-81.  As shown on the screening sheets, staff began answering screening questions for fatigue, headache, nausea or vomiting, and recent loss of taste or smell once RIDOH sent out an updated screening tool on October 26, 2020.  CMS Ex. 7 at 25-26.  Therefore, the record indicates good faith actions by Petitioner to promptly follow RIDOH screening tool changes as they were notified of them.

**Page 29**

Petitioner’s implementation of the symptom screening as provided by RIDOH on August 13, 2020 and October 26, 2020, shows compliance with the ICP, which anticipated RIDOH would update the screening tool.  Therefore, Petitioner’s failure to screen staff for fatigue, headache, nausea or vomiting, and recent loss of taste or smell from August 14 to October 26, 2020, does not support a finding of noncompliance with 42 C.F.R. § 483.80.

**CMS’s determination that Petitioner’s noncompliance with 42 C.F.R. § 483.80(a)(1)-(2) 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 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 determinations of immediate jeopardy have been sustained 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).

CMS argues that contrary to its ICP, Petitioner failed to ensure its screening policies were implemented and consistently followed when it:  allowed Staff A, who subsequently tested positive for COVID-19, to work despite reporting COVID-19 symptoms on eight separate occasions; permitted employees to work even though the employees had not been cleared by a second staff member; and did not verify that abnormally low staff temperatures were accurate.  CMS Br. at 30.  CMS contends Petitioner’s failure to follow its ICP demonstrated a significant disregard for adherence to infection control policies and procedures at a time when the severity of COVID-19 was well-known to Petitioner; therefore, CMS’s determination of immediate jeopardy noncompliance is not clearly erroneous. CMS Br. at 31.

Petitioner argues that the state agency did not properly apply CMS guidance documents and only based its immediate jeopardy determination on a “potential” for harm rather than a “reasonable expectation.”  P. Br. at 32.  Petitioner claims CMS has not demonstrated any likelihood of serious harm related to its screening tool deficiencies

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because as Captain Seon-Spada testified, there was only a “potential” for harm and the incorrect calibration of a thermometer “may” have resulted in the entry of a staff member who had a fever.  P. Br. at 31-32 (citing CMS Ex. 12 ¶¶ 8, 9; Tr. 33).

However, the statute and the regulations are controlling, not CMS guidance manuals.  “The [State Operations Manual (SOM)], in general, is a compilation of interpretive guidelines, standards of practice, and internal policies directed to the state survey agencies that conduct long-term care facility surveys and that certify facility compliance . . . . While the SOM may reflect CMS’s interpretations of the applicable statutes and regulations, the SOM provisions are not substantive rules themselves.”  *Foxwood Springs Living*, DAB No. 2294 at 8-9 (2009). Therefore, I apply the regulations in this case without determining whether the specific provisions of the SOM are correct and regardless of whether the surveyor complied with the SOM. I base my analysis in this case on the definition of immediate jeopardy in the regulations.

Petitioner points to Dr. Katz’s testimony that the entire screening process is ineffective.  Petitioner asserts that if this is true, then there can be no deficiency because there would not be any chance of more than minimal harm for Petitioner’s conduct. P. Br. at 32-33.

Dr. Katz opines that screening processes for COVID-19 symptoms “are ineffective at best in preventing the disease’s spread.” P. Ex. 10 ¶ 17.  Dr. Katz’s basis for this opinion is simply that approximately 40% of individuals carrying the COVID-19 virus may transmit it completely asymptomatically.  “Even if an individual does develop symptoms consistent with COVID-19, they may transmit the virus up to two days before presenting any such symptoms.  Moreover, symptoms that those carrying the virus present – such as fatigue, headache, or shortness of breath – are oftentimes vague and attributable to many allergies or non-infectious diseases.”  P. Ex. 10 ¶ 16.  Dr. Katz further testified that a combination of testing on a regular basis and consistent use of personal protective equipment is “the best method of protection for long-term facilities against COVID-19.”  P. Ex. 10 ¶ 17.

I do not credit Dr. Katz’s opinion indicating that symptom screening processes are “ineffective at best.”  Dr. Katz cited no studies or authorities to support her view that screenings provide no assistance in protecting facilities.  Further, Dr. Katz advocated a layered approach to combating COVID-19 with testing and wearing of personal protective equipment. P. Ex. 10 ¶ 17.  Dr. Katz does not explain why an additional layer of protection involving staff screening is of no assistance to keeping SNFs free of COVID-19. Moreover, the CDC’s guidance is replete with detailed actions facilities should take to reduce the chance of spreading COVID-19.  CMS Ex. 5 at 3 (“Screen all HCP at the beginning of their shift for fever and symptoms of COVID-19.”).  Both the CDC and RIDOH recommended screenings, and following that guidance, Petitioner made screenings an important part of its ICP, specifically re-educating facility staff on

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screening procedures on October 26, 2020.  CMS Ex. 5 at 3; CMS Ex. 6; CMS Ex. 11 at 1-3; P. Exs. 12, 13.

As CMS witness Captain Seon-Spada testified, Dr. Katz’s testimony concerning the lack of effectiveness of screenings “stands in contradiction to nationally accepted standards, including those established by the CDC as well as practice tips published by the American Medical Association and relevant medical literature.”  CMS Ex. 12 ¶ 8(d).  Captain Seon-Spada further explained, “the screening tool is an effective component of a strong infection prevention and control program. Petitioner serves residents who are at high risk of being affected by respiratory pathogens like COVID-19.  If these residents contract COVID-19, the potential health consequences are severe, and may include death.”  CMS Ex. 12 ¶ 8(d).  There is no evidence that staff screening cannot “help prevent” the spread of infections, which is the statutory requirement for ICPs in 42 U.S.C. § 1395i-3(d)(3)(A).  Petitioner adopted screening as part of its ICP and was bound to properly implement the screenings, showing that Petitioner believes that screening “helps prevent” the spread of COVID-19.

Petitioner also argues the record does not support that the alleged deficiency was likely to cause serious injury, harm, impairment, or death to a resident because “a COVID outbreak and/or infection was not ‘probable’ or ‘reasonably to be expected’ from the alleged deficiencies.”  P. Br. at 28-29.  Petitioner asserts there was no “likelihood” of COVID-19 infection related to Staff A because Staff A did not have resident contact.  P. Br. at 30.  Moreover, Petitioner states that the screening errors were of such a limited nature that there would not have been any likelihood of harm to residents.  P. Br. at 31.

Contrary to Petitioner’s arguments, the record supports a finding of immediate jeopardy.  COVID-19 represents a major threat to nursing home residents both because it is highly contagious, and very harmful to infirmed and aged persons located in a congregate facility.  The CDC explained that:

Given their congregate nature and resident population served (e.g., older adults often with underlying chronic medical conditions), nursing home populations are at high risk of being affected by respiratory pathogens like COVID-19 and other pathogens . . . As demonstrated by the COVID-19 pandemic, a strong infection prevention and control (IPC) program is critical to protect both residents and healthcare personnel (HCP).”12

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CMS Ex. 5 at 1.  The CDC found that COVID-19 spreads “mostly person-to-person through respiratory droplets when someone coughs, sneezes, or talks.  It is possible that a person can get COVID-19 by touching a surface or object . . . that has the virus on it and then touching their own mouth, nose, or possibly their eyes.”  P. Ex. 14 at 1.  It is clear that COVID-19 is extremely dangerous in the SNF setting.

Consistent with the CDC’s findings, Petitioner’s ICP acknowledges the seriousness and severity of COVID-19.  The ICP states that it complies with the CDC and RIDOH guidance regarding awareness and prevention of COVID-19 and prescribes steps that must be taken to “promote a culture of safety and to help ensure optimal surveillance of signs and symptoms of COVID-19.”  CMS Ex. 6 at 1.

Ms. Marcaccio testified in support of a finding of immediate jeopardy:

Petitioner’s failure to implement its screening tool on forty-five occasions was not miniscule.  While these failures may have amounted to a relatively small percentage of the total screenings completed between August 1, 2020 and November 23, 2020, any one of these failures risked permitting entry to a staff member who was positive for COVID-19 and who had the ability to transmit COVID-19 to all residents, either directly or indirectly.  Given the population that Petitioner serves, if residents contracted COVID-19, they faced severe health consequences, including death.

Based on my review of the relevant documentation, Petitioner was noncompliant with 42 C.F.R. § 483.80 at the immediate jeopardy level because it failed to implement its infection control policy for COVID-19 when permitting Staff A to work on eight occasions while symptomatic and when failing to implement its screening tool on forty-five occasions between August 2020 and November 2020.  These failures put all of its residents at-risk because these failures had the potential to permit staff who had COVID-19 to transmit it directly or indirectly to other residents.  Given the population that Petitioner serves, if residents contracted COVID-19 they faced severe health consequences, including death.

CMS Ex. 13 ¶¶ 4(b)(v), 5.

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Captain Seon-Spada also testified in support of a finding of immediate jeopardy:

While Petitioner further argued in its Prehearing Exchange that Staff A’s COVID-19 diagnosis did not immediately jeopardize its residents, I note that, based on my clinical experience and review of relevant medical literature, Staff A had the potential to transmit COVID-19 to any staff that she came into contact with and these staff members then had the potential to transmit COVID-19 to residents.  Thus, given the high transmission rate of COVID-19, particularly in the vulnerable population cared for at Petitioner’s facility, Petitioner’s residents were in immediate jeopardy when Petitioner permitted Staff A to work while symptomatic on eight occasions.

CMS Ex. 12 ¶ 8(a)(ii).

As Ms. Marcaccio and Captain Seon-Spada testified, Petitioner’s failure to comply with its ICP immediately jeopardized the health and safety of residents.  Petitioner allowed Staff A to work on eight days even though she reported multiple COVID-19 symptoms on all eight of those days.  CMS Ex. 7 at 1; P. Ex. 1 ¶¶ 13-17.  Ten days after she first reported symptoms, Staff A reported a new symptom of diarrhea while continuing to have muscle or body aches, fatigue, and a headache, yet she was again allowed to work.  CMS Ex. 7 at 1; P. Ex. 1 ¶ 17.  Further, Petitioner’s ICP states that if an HCP answers “yes” to any of the screening questions, the HCP will not be allowed in the facility until further evaluation and questioning is completed.  CMS Ex. 6 at 2.  Petitioner thought it was important to evaluate anyone who reported positive symptoms and explicitly included it in the ICP, yet there is no documentary evidence Petitioner evaluated Staff A before allowing her to work and ruled out COVID-19 as the cause of Staff A’s symptoms.

Additionally, despite the June 2020 CDC guidance that established testing as a core practice for infection prevention and control (CMS Ex. 5 at 2-3), Petitioner’s testing of Staff A does not help Petitioner prove there was no immediate jeopardy.  Petitioner did not test Staff A on November 12, when she first reported three symptoms of COVID-19.  CMS Ex. 7 at 1; P. Ex. 1 ¶ 14.  Two days later, Staff A again reported three COVID-19 symptoms, yet Petitioner did not test Staff A until 7:31 p.m., after Staff A had worked from 5:52 a.m. to 1:36 p.m. CMS Ex. 7 at 1, 8, 11; P. Ex. 1 ¶ 14.  Staff A reported multiple positive symptoms again on November 15 and 16 but did not undergo testing at all.  CMS Ex. 7 at 1.  Even though Staff A tested negative on November 14, the facility should have tested her on November 15 and 16 since she continued to have numerous symptoms. Staff A still had symptoms four days later on November 20, and while the

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facility did test her, she only completed a rapid antigen test, as opposed to a more accurate RT-PCR test.  CMS Ex. 7 at 10; P. Ex. 1 ¶ 15.  Staff A completed a rapid antigen and RT-PCR test, both of which were negative, on November 21.  CMS Ex. 7 at 9, 10; P. Ex. 1 ¶ 16.  However, the next day, even when Staff A had a new symptom of diarrhea along with continued muscle or body aches, fatigue, and headache, the facility did not test her.  CMS Ex. 7 at 1; P. Ex. 1 ¶ 17.

Petitioner’s failure to follow its ICP concerning Staff A is all the more serious because Petitioner had recently experienced an outbreak of COVID-19 at the end of October 2020, and the northeast region of the United States, including Rhode Island, was experiencing a “severe COVID-19 outbreak.” P. Ex. 1 ¶¶ 9-10.

The failures of a second staff to sign off on employees reporting to work and to check the thermometer when employees’ temperatures were extremely low also were likely to result in serious injury, harm, or death.  Petitioner’s non-adherence to its ICP occurred for at least several months.  Staff reported temperatures below 95° in August, early September, and November 2020.  CMS Ex. 7 at 18, 19, 21, 22, 24, 28, 31.  Staff A signed herself in without a second staff verification on September 19 and Staff N, O, P, and Q were not verified by a second employee in November 2020.  CMS Ex. 7 at 1, 4, 15-17, 28-31.  Although Petitioner claims that these failures comprised only a small percentage of the total screenings completed between August and November 2020, as Captain Seon-Spada and Ms. Marcaccio testified, any one of these failures could have resulted in a staff member with COVID-19 being allowed into the facility and transmitting COVID-19 to residents and other staff.  CMS Ex. 12 ¶ 8(a)(ii); CMS Ex. 13 ¶¶ 4(b)(v), 5.

As stated in the controlling statute, the ICP has “to **help** prevent the development and transmission of disease and infection.” 42 U.S.C. § 1395i-3(d)(3)(A); 42 C.F.R. § 483.80 (emphasis added).  There is no doubt that Petitioner, CDC, and CMS all thought screening could “help.”  Petitioner’s ICP acknowledges the seriousness of COVID-19 and outlines the steps that must be taken to “promote a culture of safety and to help ensure optimal surveillance of signs and symptoms of COVID-19,” which includes screening every staff member reporting to work and having a second employee clear the staff member to enter.  CMS Ex. 6 at 1.  Infection prevention and control measures are particularly important during a pandemic involving a highly contagious virus, especially in a congregate setting where residents and staff are often in close contact with each other.  Given the contagiousness and severity of COVID-19, Petitioner’s failure to consistently implement its ICP was likely to cause serious harm, injury, and even death to residents.  Therefore, CMS’s determination that Petitioner’s noncompliance immediately jeopardized resident health and safety is not clearly erroneous. *See Golden Living Ctr. - Superior*, DAB No. 2768 at 25 (“Given . . . Golden’s own description of the nature of the health risk to its residents, it clearly was not erroneous for CMS to determine that Golden’s failure to fully or promptly implement three influenza control precautions was likely to cause serious harm to residents.”).

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**Enforcement Remedies**

**Petitioner did not dispute the DPNA that CMS imposed on Petitioner from December 19, 2020 through December 29, 2020; therefore, that enforcement remedy is binding on Petitioner. CMS Ex. 2.
	In light of the conclusion that some of CMS’s allegations of noncompliance were not upheld, the $15,975 per‐day CMP for six days from November 24 through November 29, 2020, is no longer reasonable.  A reduced CMP of $13,975 per-day CMP for those six days is appropriate.  The $225 per-day CMP for 30 days from November 30 through December 29, 2020, is reasonable and does not need to be further reduced because it is near the bottom of the penalty range already.**CMS imposed a $15,975 per-day CMP for six days (November 24 through November 29, 2020) and $225 per-day CMP for 30 days (November 30, 2020 through December 29, 2020) for a total CMP of $102,600.  CMS Ex. 1 at 1, 3; CMS Ex. 2 at 1-2.  When CMS imposes a per-day CMP, an SNF may challenge the amount and duration of the CMP.

**Duration of CMP**

Petitioner did not challenge the duration of the CMP.  The SNF bears the burden of showing that its noncompliance was of shorter duration than alleged by CMS.  *Owensboro Place & Rehab. Ctr.*,**DAB No. 2397 at 12 (2011) (citing *Kenton Healthcare, LLC*, DAB No. 2186 at 24-25 (2008) and *Lake Mary Health Care*, DAB No. 2081 at 30 (2007)).  Therefore, I accept the duration as found by CMS.

**Amount of CMP**

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-3(h)(2)(B)(ii)(I). The absence of culpability is not a mitigating factor.  42 C.F.R. § 488.438(f).  The factors listed 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.  *See*42 U.S.C. §§ 1320a-7a(d)(1), (3), 1395i-3(h)(2)(B)(ii)(I).

The regulations leave the decision regarding the choice of remedy to CMS, and the amount of the remedy to CMS and the ALJ, requiring only that the regulatory factors at

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§§ 488.438(f) and 488.404 be considered when determining the amount of a CMP within a particular range.  42 C.F.R. §§ 488.408, 488.408(g)(2); 498.3(d)(11); *see also* 42 C.F.R. § 488.438(e)(2) and (3); *Alexandria Place*, DAB No. 2245 at 27 (2009); *Kenton Healthcare, LLC*, DAB No. 2186 at 28-29. However, unless a facility contends that a particular regulatory factor does not support the CMP amount, an ALJ must sustain it.  *Coquina Ctr.*, DAB No. 1860 (2002).

CMS argues the amount and duration of the CMPs imposed are reasonable. CMS notes the $15,975 and $225 per-day amounts are substantially less than the maximum penalties permitted. While CMS does not address the statutory and regulatory factors, CMS asserts Petitioner is responsible for its failures to implement its own ICP, including its actions and omissions regarding screening employees.  CMS Br. at 32-34.

**Facility’s History of Noncompliance:**Petitioner claims it does not have any history of non-compliance as four infection control surveys completed during the COVID-19 pandemic did not find any deficiencies. P. Br. at 34; P. Ex. 1 ¶ 12; P. Ex. 8; Tr. 14-15.  CMS did not submit evidence of Petitioner’s history of non-compliance.  Therefore, Petitioner’s history of noncompliance is not a factor supporting the CMP amounts.

**Financial Condition of the Facility:**Petitioner argues that the CMP amount would cripple the facility financially.  P. Br. at 34 (citing P. Ex. 15).  Petitioner is a third-generation family-owned facility employing 55 individuals. Tr. 14.  Petitioner’s facility has 62 beds, which Captain Seon-Spada testified would be considered a “smaller facility to mid-range.” Tr. 14.  Petitioner acknowledges that CMS granted the facility’s hardship request and approved a 24-month extended payment plan (CMS Ex. 10), but claims the “payment plan does not lower the burden on Mansion whatsoever because the amount of the CMP remains the same and will cause substantial financial harm to the facility.”  P. Br. at 35.

The “relevant inquiry” in assessing a facility’s financial condition is “whether the facility can show that it lacks ‘adequate assets to pay the CMP without having to go out of business or compromise resident health and safety.’”  *Vibra Hosp. of Charleston – TCU*, DAB No. 3094 at 32 (2023) (citing *Oceanside Nursing & Rehab. Ctr.*, DAB No. 2382 at 23 (2011)); *see also Gilman Care Ctr.*, DAB No. 2357 at 7 (2010); *Western Care Mgmt. Corp.*, DAB No. 1921 at 91 (2004) (citing *Windsor Health Care Ctr.*, DAB No. 1902 (2003)); Final Rule, Medicare and Medicaid Programs; Survey, Certification and Enforcement of Skilled Nursing Facilities and Nursing Facilities, 59 Fed. Reg. 56,116, 56,204 (Nov. 10, 1994)*.*“[A] facility’s annual profits or losses may not be an accurate reflection of a facility’s financial health or ability to pay, and must be considered in the light of such other indicators as the facility’s financial reserves, assets, credit-worthiness, and ‘other long-term indicia of its survivability.’”  *Gilman Care Ctr.*, DAB No. 2357 at 8-9, and cases cited therein.  A facility has the burden of proving its inability to pay the

**Page 37**

CMP by a preponderance of the evidence.  *Oaks of Mid City Nursing & Rehab. Ctr.*, DAB No. 2375 at 26 (2011); *Gilman Care Ctr.*, DAB No. 2357 at 7.

Petitioner has not met its burden of proof to show that it lacks adequate assets to pay the CMP without having to go out of business or compromise resident health or safety.  In a January 27, 2021 letter addressed to Captain Seon-Spada, Petitioner’s President stated that “a CMP of $102,600 would essentially eliminate our bottom line and cripple our ability to survive let alone consider urgently needed wage increases to retain our nursing staff and others essential to our operation.”  P. Ex. 15 at 1.  Petitioner’s Administrator testified that while COVID government funding allowed the facility to remain operational in 2020 and 2021, the CMP would “cripple Mansion financially” and “create a dire financial situation for Mansion and exacerbate the already difficult circumstances caused by COVID-19.”  P. Ex. 1 ¶ 28.

According to the facility’s President and Administrator, the facility’s taxable income was $71,697 in 2018 and $176,057 in 2019.  P. Ex. 1 ¶ 27; P. Ex. 15 at 1.  Petitioner’s President attached copies of the facility’s 2018 and 2019 tax returns to its January 27, 2021 letter to Captain Seon-Spada and mentioned that it would provide the facility’s 2020 year-end balance sheet in several weeks.  P. Ex. 15 at 1.  However, Petitioner did not submit any of those tax returns in this case.  Moreover, Petitioner’s reliance only on the facility’s 2018 and 2019 taxable income as support for its inability to pay the CMP is not sufficient to establish an inability to pay the CMP.  Petitioner did not submit any other evidence of the “facility’s financial reserves, assets, credit-worthiness, and other long-term indicia of its survivability” that could support its claim of a dire financial situation.  *Gilman Care Ctr.*, DAB No. 2357 at 8-9.  Therefore, Petitioner has not shown that its financial condition warrants a reduction in the CMP.

**Scope and Severity of Deficiencies and Relationship Between Deficiencies:** CMS determined Petitioner’s noncompliance with 42 C.F.R. § 483.80(a) caused immediate jeopardy to resident health and safety.  Petitioner indicates the noncompliance consisted of isolated incidents.  P. Br. at 34.

The record shows that Petitioner’s non-adherence to its ICP occurred for at least several months.  Staff reported temperatures below 95° in August, early September, and November 2020. A second staff member did not sign off on Staff A entering the facility in September and November 2020, and Staff N, O, P, and Q were also not verified by a second employee in November 2020.  While these failures comprised just a small percentage of the total screenings completed between August and November 2020, any one of these failures could have resulted in a staff member transmitting COVID-19 to residents and other staff.  Therefore, this factor justifies a reasonably high CMP amount.

**Page 38**

**Culpability:**  Petitioner argues it adhered to its screening policy and has no culpability.  Petitioner also claims that through its rigorous efforts, it has “accomplished an extraordinary record throughout the COVID-19 pandemic, including an eight-month COVID-19 free environment.”  P. Br. at 34.  However, the record shows some culpability, which supports the CMP amount imposed.

Staff A indicated she had multiple COVID-19 symptoms when she reported to work on November 12, yet the facility permitted Staff A to work without testing Staff A or further evaluating her to confirm that she did not have COVID-19.  Between then and November 24, Staff A worked eight more times even though her numerous COVID-19 symptoms persisted and she presented with a new symptom of diarrhea on November 22, 2020.  Even if Staff A did not have any resident contact, Staff A could still transmit COVID-19 to other staff members, who in turn could transmit it to residents.  Therefore, although Staff A did not test positive until November 24, Petitioner’s failure to consistently test or assess Staff A to ensure she did not have COVID-19 shows neglect, indifference, or disregard for resident safety.

Additionally, Petitioner’s failure to ensure a second staff member signed off on all employees entering the facility and verify the accuracy of staff screening temperatures shows  neglect, indifference, or disregard for resident safety.  Infection prevention and control measures are critical in nursing homes with residents at high risk for serious consequences from COVID-19.  Petitioner may have been fairly vigilant throughout the pandemic, but the evidence shows problems with its screening process before and during the survey at issue.  The facility had just experienced a COVID-19 outbreak and Rhode Island had recently documented a record high daily positive rate.  Therefore, it was important for the facility to fully implement its ICP to prevent the development and transmission of COVID-19.

However, in mitigation, I have found that one of the most significant allegations supporting the deficiency in this case (i.e., the facility’s removal of some of the symptoms from staff screening) was done in furtherance of ensuring compliance with the ICP.  Petitioner’s actions were based on an error by RIDOH. Oddly, Petitioner’s immediate changes to its screening to conform with RIDOH’s changes, both with the erroneous information provided by RIDOH and then when RIDOH corrected the errors, show that Petitioner took action to immediately implement its ICP.  In fact, its commitment to following the ICP may be the reason why Petitioner avoided COVID-19 infections at the facility until October 2020.  P. Ex. 1 ¶¶ 8-9; *see also* P. Ex. 8 at 1-6.  The allegation that Petitioner improperly removed a number of COVID-19 symptoms from its staff screening related to a period of two months, making it a significant part of CMS’s allegations in support of the CMP in this case due to the widespread nature of that alleged deficient conduct (i.e., the entire staff was not being screened for four COVID-19 symptoms).  Because I have concluded that those allegations do not support the deficiency in this case, they also do not support the CMP amount imposed.  Therefore,

**Page 39**

this factor, while supporting a significant CMP, would also weigh in favor of a reduction in the CMP amount as imposed by CMS because Petitioner’s culpability was not as high as CMS originally believed.

**CMP Amount:**  As indicated, CMS imposed a $15,975 per-day CMP for six days from November 24 through November 29, 2020, and a $225 per-day CMP for 30 days from November 30 through December 29, 2020, for a total CMP of $102,600. The $15,975 per-day CMP imposed is near the middle of the range for immediate jeopardy noncompliance.  The $225 per-day CMP imposed is low and near the minimum $112 per-day amount.  45 C.F.R. § 102.3; 85 Fed. Reg. at 2880.

As stated in the analysis above concerning the Petitioner’s culpability, I noted that I did not uphold significant allegations made by CMS and that a reduction in the CMP imposed was warranted.  Therefore, based on and assessment of the factors above, with consideration for CMS’s original CMP amount, I reduce the CMP amount for the period of IJ by $2,000 per day to $13,975.  I do not reduce the $225 per-day CMP for the period of non-IJ noncompliance because that amount is near the bottom of the CMP range already. Therefore, the total CMP imposed in this case is reduced by $12,000 to $90,600.

V.     Conclusion

I uphold CMS’s determination that Petitioner was not in substantial compliance with 42 C.F.R. § 483.80(a)(1)-(2) and that the noncompliance immediately jeopardized the health and safety of residents.

Petitioner is subject to a DPNA from December 19 through 29, 2020.

Petitioner is liable to pay a CMP of $13,975 per day for six days from November 24 through November 29, 2020, and $225 per day from November 30 through December 29, 2020, for a total CMP of $90,600.

Endnotes

1  “It is the duty and responsibility of the Secretary to assure that requirements which govern the provision of care in skilled nursing facilities . . . are adequate to protect the health, safety, welfare, and rights of residents and to promote the effective and efficient use of public monies.”  42 U.S.C. § 1395i-3(f)(1).

2  All citations to the Code of Federal Regulations are to the version in effect at the time of the survey unless otherwise indicated.

3  State agencies designate the scope and severity level using a matrix published in the State Operations Manual, ch. 7, § 7400.5 (Sept. 10, 2010).  Scope and severity levels of A, B, or C describe deficiencies for which CMS cannot impose enforcement remedies.  Scope and severity levels of D, E, or F describe deficiencies that present no actual harm, but have the potential for more than minimal harm that do not amount to immediate jeopardy.  Scope and severity levels of G, H, or I indicate deficiencies that involve actual harm that do not amount to immediate jeopardy.  Scope and severity levels J, K, and L describe deficiencies that constitute immediate jeopardy to resident health or safety.

4  Morgan Katz, M.D., M.H.S., is Petitioner’s expert witness and is an Assistant Professor in the Department of Medicine at Johns Hopkins University Hospital.  P. Ex. 10 at 1-2, 9.  From 2011 to 2014, Dr. Katz completed a fellowship in Infectious Diseases at Johns Hopkins University School of Medicine and now serves on the Infectious Disease faculty at Johns Hopkins.  P. Ex. 10 at 1-2, 9.  Teresa Chopoorian, Ed.D, MSN, RN, was Petitioner’s Director of Nursing from 1985-1986 and Assistant Administrator from 1986-1989, and has been Administrator since 1989.  P. Ex. 1 at 9.  Nathan Blundo has served as Petitioner’s Business Operations Associate since August 2014.  P. Ex. 9 ¶ 1.

5  Jessica Marcaccio, RN, is the Principal Nursing Care Evaluator for the state agency.  CMS Ex. 13 ¶ 1.  Hyosim Seon-Spada, DNP, MSN, APRN, RN, is a Captain in the U.S. Public Health Service Commissioned Corps and is the Survey & Long Term Care Branch Manager for CMS’s Northeast Survey and Enforcement Division, Survey and Operations Group for Center for Clinical Standards and Quality, Region I.  CMS Ex. 12 ¶¶ 1-3.

6  I informed the parties that post-hearing briefing had to include all issues and arguments that the parties wanted me to consider when rendering a decision.  Hearing Transcript (Tr.) 86-87; April 1 Order at 1.

7  All temperatures referenced in this decision use the Fahrenheit scale.

8  CMS revised the Part 483 regulations concerning SNF conditions of participation in 2016.  Medicare and Medicaid Programs; Reform of Requirements for Long-Term Care Facilities, 81 Fed. Reg. 68,688 (Oct. 4, 2016); 82 Fed. Reg. 32,256 (July 13, 2017) (technical corrections).  The infection prevention and control regulation currently promulgated in 42 C.F.R. § 483.80was formerly found in 42 C.F.R. § 483.65.  In assessing compliance under §483.80 in this case, I consider case decisions analyzing the former § 483.65.

9  Petitioner asserts that the surveyor failed to seek or request documentation or information regarding the Administrator’s alleged evaluations of Staff A. P. Br. at 21 (*citing* P. Ex. 1 ¶ 25); *see* Tr. 39-40.  However, staff presenting with COVID-19 symptoms were presumptively not to be allowed into the facility unless evaluated (CMS Ex. 5 at 3; CMS Ex. 11 at 1); therefore, the burden is on Petitioner to show that Staff A was properly allowed into the facility in accordance with its ICP.  Petitioner references text message communications between the Administrator and Staff A.  P. Br. at 21.  Even if the surveyor did not ask for documentation, Petitioner had an opportunity in this proceeding to submit copies of those text messages, and any other documentation supporting its claim that the Administrator conducted appropriate evaluations of Staff A.  Petitioner did not do so.

10  On October 21, 2020, Petitioner’s facility had its first staff member test positive and on October 28, 2020, the facility had its first resident test positive for COVID-19.  P. Ex. 1 ¶ 9.  By November 27, 2020, the last resident finished quarantine.  P. Ex. 1 ¶ 11.  While there had been a COVID-19 outbreak at the facility, CMS does not directly argue causation between the outbreak and the events involving Staff A.  However, such an outbreak should have heightened Petitioner’s awareness of the highly contagious nature of COVID-19.

11  The first version of this form, Petitioner Exhibit 12, has “August 14, 2020” handwritten on it.  Petitioner then filed Petitioner Exhibit 16, which had an August 13, 2020 email from RIDOH attaching the screening tool from Petitioner Exhibit 12; however, the August 14, 2020 handwritten date does not appear.

12  Petitioner’s medical expert, Dr. Katz, testified in another proceeding “that her research showed that COVID-19 would pose significant risks to SNFs because:  1) the resident population is highly vulnerable and suffers the worst outcomes from this disease; 2) residents require close personal care from staff; and 3) residents reside in structures meant for group living.”  *Life Care Ctr. of St. Louis*, DAB CR6286 at 20 (2023).
  
          /s/
        Scott Anderson

                      Administrative Law Judge Back to top
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