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# St. Jude Operating Company dba Health Care at Foster Creek, DAB CR6355 (2023)

----

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

## St. Jude Operating Company dba Health Care at Foster Creek ,(CCN: 385281),Petitioner,

## v.

## Centers for Medicare & Medicaid Services.

### Docket No. C-20-667Decision No. CR6355September 18, 2023

### DECISION

St. Jude Operating Company dba Health Care at Foster Creek (Petitioner or “the facility”) challenges the determinations by the Centers for Medicare & Medicaid Services (CMS) that it was out of compliance with the Medicare program participation requirements regarding staffing (42 C.F.R. § 483.35(a)(1), (2)) (cited as Tag F-725) and infection prevention and control (42 C.F.R. § 483.80(a)(1), (2), (4); (e), (f)) (cited as Tag F-880) and that these deficiencies amounted to immediate jeopardy to resident health and safety.  Petitioner also challenges the remedy imposed of a civil monetary penalty (CMP) of $283,920 based on 26 days of immediate jeopardy noncompliance at $10,920 per day. 

For the following reasons, I uphold CMS’s determination that Petitioner’s noncompliance with the Medicare participation requirements for infection prevention and control caused immediate jeopardy to resident health and safety.  Because CMS did not address the deficiency related to staffing, I do not uphold that deficiency and I reduce the CMP accordingly to account for a single immediate jeopardy deficiency.  I uphold a per-day CMP of $6,808 for 26 days of immediate jeopardy noncompliance.1 

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### I.    Background

The Social Security Act (Act) establishes requirements for skilled nursing facility (SNF) participation in the Medicare program and authorizes the Secretary of Health and Human Services (Secretary) to promulgate regulations implementing those statutory provisions.  *See*42 U.S.C. § 1395i-3; 42 C.F.R. pts. 483 and 488.  To participate in the Medicare program, SNFs must maintain substantial compliance with program participation requirements.  In order to be in substantial compliance, any deficiencies may “pose no greater risk to resident health or safety than the potential for causing minimal harm.”  42 C.F.R. § 488.301.  “Noncompliance” means “any deficiency that causes a facility to not be in substantial compliance.”  *Id*.  

The Secretary contracts with state agencies to conduct periodic surveys to determine whether SNFs are in substantial compliance with participation requirements.  42 U.S.C. § 1395aa(a); 42 C.F.R. §§ 488.10, 488.20.  The Act and its implementing regulations require that facilities be surveyed on average every twelve months, and more often if necessary, to ensure that identified deficiencies are corrected.  42 U.S.C. § 1395i‐3(g)(2)(A); 42 C.F.R. §§ 488.20(a), 488.308.  During the COVID-19 pandemic, surveyors conducted focused infection control surveys of SNFs to investigate compliance with Medicare participation requirements pertaining to infection prevention and control, as occurred with Petitioner.  *See* P. Ex. 24 (CMS Memorandum QSO-20-20-All (March 20, 2020) (“Prioritization of Survey Activities”)).  

CMS may impose a per-day CMP for the number of days a facility is not in substantial compliance or a per-instance CMP for each instance of the SNF’s noncompliance.  42 U.S.C. § 1395i-3(h)(2)(B)(ii); 42 C.F.R. § 488.430(a).2  If CMS imposes a remedy based on a noncompliance determination, then the facility may request a hearing before an administrative law judge (ALJ) to challenge the noncompliance finding and enforcement remedy.  42 U.S.C. §§ 1320a-7a(c)(2), 1395i‐3(h)(2)(B)(ii); 42 C.F.R. §§ 488.408(g), 488.434(a)(2)(viii), 498.3(b)(13). 

The Oregon Department of Human Services (state agency) conducted a COVID-19 focused survey of the facility from April 10 through April 24, 2020, and cited, *inter alia*, immediate jeopardy noncompliance3 with the Medicare program participation

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requirements found at 42 C.F.R. § 483.35(a)(1), (2) (cited as Tag F-725) and 42 C.F.R. § 483.80(a)(1), (2), (4); (e), (f) (cited as Tag F-880) at the “L” level scope and severity.4  CMS Ex. 1 at 9, 26. 

In a letter dated April 29, 2020, CMS informed Petitioner that it had adopted the state agency’s findings.  CMS Ex. 26 at 2.  CMS imposed a per-day CMP of $10,710 for the immediate jeopardy noncompliance, effective April 10, 2020.5  CMS Ex. 26 at 2.  On May 27, 2020, CMS informed Petitioner that its provider agreement would be terminated effective May 30, 2020.  CMS also informed Petitioner that the per-day CMP was $10,920 for the period April 10, 2020 through May 17, 2020.  CMS Ex. 25 at 1.  The following month, on July 21, 2020, CMS determined that immediate jeopardy noncompliance continued through May 5, 2020, which was “the date of the departure of the last remaining resident” at the facility.  CMS Ex. 28.  At that time, CMS informed Petitioner that the duration of the CMP was revised, with a per-day CMP of  $10,920 for the period April 10, 2020 through May 5, 2020.  CMS Ex. 28. Petitioner timely requested a hearing on July 24, 2020.  CMS filed a pre-hearing brief (CMS Pre-Hrg. Br.), along with 27 proposed exhibits (CMS Exs. 1-27), and Petitioner filed a pre-hearing brief and 59 proposed exhibits (P. Exs. 1‐59).  At the time of the May 4, 2021 pre-hearing conference, I admitted all of the proposed exhibits, with CMS Exs. 23 and 24 provisionally admitted pending the appearance of the witnesses for cross-examination.  *See* May 5, 2021 Order Summarizing Pre-Hearing Conference. 

By order dated June 21, 2021, I admitted CMS Ex. 28, which CMS filed on May 7, 2021.  

CMS submitted the written direct testimony of two surveyors (CMS Exs. 23 (Ms. White) and 24 (Ms. Myers)), and both witnesses were cross-examined at the June 25, 2021 hearing.  Petitioner submitted the testimony of nine staff members (P. Exs. 47-55).  Petitioner also submitted the written testimony of Morgan J. Katz, M.D. (P. Ex. 56),

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Bryan W. McEachern, M.D. (P. Ex. 57), and David C. Grabowski, Ph.D. (P. Ex. 58).  CMS did not request an opportunity to cross-examine any of Petitioner’s witnesses.  

Following the videoteleconference hearing held on June 25, 2021, a transcript (Tr.) was made available to the parties.  I issued a July 26, 2021 order directing, *inter alia*, each party to file certain documentary evidence as a proposed exhibit(s).  Pursuant to that order, Petitioner filed P. Exs. 60 and 61 as proposed exhibits, and also filed a post-hearing brief (P. Post-Hrg. Br.) and post-hearing reply brief (P. Post-Hrg. Reply Br.).  However, even though CMS filed the post-hearing brief that was directed by the same order, it did not file the requested documentary evidence (a resident and staff identifier key) as a proposed exhibit. 

On September 8, 2021, I directed CMS to show cause why a sanction should not be imposed based on its failure to file a copy of the resident and staff identifier key pursuant to my previous order.  CMS neither filed the requested evidence as a proposed exhibit nor filed a response to the order directing it to show cause. 

On September 30, 2021, I issued an order striking CMS’s post-hearing briefs as a sanction for its failure to respond to the July 26 and September 8, 2021 orders.  I also ordered that “[t]he record is closed.” 

Thereafter, CMS filed the requested evidence as a proposed exhibit (CMS Ex. 28).  However, CMS did not seek leave to file “CMS Ex. 28”6 out of time or request leave to re-open the closed record.  Further, CMS reported, in a motion seeking reconsideration of the sanction order, that it did not timely file the requested evidence or respond to the orders because it “simply did not see the orders.”7  In an order dated October 7, 2021, I denied CMS’s motion for reconsideration of the sanction order and ordered that the record would remain closed. 

In summary, I have admitted CMS Exs. 1-28 and P. Exs. 1-61 into the evidentiary record. 

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### II.    Issues

At the May 4, 2021 pre-hearing conference, the parties agreed that the following issues are presented for review: 

Whether Petitioner failed to substantially comply with 42 C.F.R. § 483.80 (Tag F880, Infection Control);

If noncompliance is established, whether the determination of immediate jeopardy is clearly erroneous;

Whether immediate jeopardy continued from April 10 through May 5, 2020.Whether a $10,920 per day CMP is reasonable. 

*See*May 5, 2021 Order Summarizing Pre-Hearing Conference; Tr. at 5. 

### III.    Discussion8

                            - *Petitioner challenged a cited deficiency involving staffing, cited as 42 C.F.R. § 483.35(a)(1), (2) (Tag F-725), in its request for hearing; because CMS did not address this deficiency in its briefing, I do not consider noncompliance with this Medicare participation requirement to be a basis for the CMP imposed. *
                            - *Petitioner has a 2011 policy entitled, “Pandemic Influenza, Infection Control Measures During,” that states that “[w]hen pandemic influenza is detected in the geographic region of the facility, infection control measures will be implemented to prevent introduction of the virus to residents, staff and visitors.” *
                            - *Petitioner implemented its Pandemic Influenza policy following the March 2020 outbreak of COVID-19. *
                            - *Petitioner’s Pandemic Influenza policy required it to restrict entry  “by any persons who have been exposed to or have symptoms of pandemic influenza,” to include screening visitors for respiratory symptoms and screening employees for influenza-like illness before coming on duty and sending symptomatic employees home. *

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                            - *Petitioner’s Pandemic Influenza policy required, in the event of an outbreak in the facility:  “adherence to standard and transmission-based precautions and other infection control measures will be implemented according to the most current [Centers for Disease Control and Prevention] [(]CDC[)] recommendations for pandemic influenza.”  *
                            - *Petitioner was out of compliance with the infection prevention and control participation requirement when on April 11, 15, and 17, 2020, it did not screen a visitor for COVID-19 upon her entry to the facility.  *
                            - *Petitioner was out of compliance with the infection prevention and control participation requirement when on April 10, 2020, a surveyor observed a medication aide who had been dispensing medications in a COVID-19 positive/presumed positive unit remove her gown, ball it up, place it on the medication cart, and then cross into a non-COVID-19 unit.  *
                            - *Petitioner was out of compliance with the infection prevention and control participation requirement when on April 11, 2020, a surveyor observed a medication aide “administer medications to a resident while wearing her mask under her chin.” *
                            - *Petitioner was out of compliance with the infection prevention and control participation requirement when on April 16, 2020, a nurse cleaned a glucometer with an alcohol swab. *
                            - *Petitioner failed to comply with 42 C.F.R. § 483.80 when it did not establish an infection prevention and control program designed to provide a safe, sanitary, and comfortable environment and to help prevent the development and transmission of communicable disease and infections.  *

**CMS waived any argument regarding the staffing deficiency cited during the April 2020 survey. **

The statement of deficiencies cited staffing, 42 C.F.R. § 483.35(a)(1), (2), as a basis for immediate jeopardy noncompliance (CMS Ex. 1 at 9-22), and the remedies imposed were based, in part, on immediate jeopardy noncompliance with this participation requirement.  CMS Ex. 26 at 2.  CMS did not address this deficiency in its brief.  *See*Order dated May 5, 2021, n.1.  (“Although Petitioner appealed another immediate jeopardy deficiency

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cited under 42 C.F.R. § 483.35(a)(1), (2) (Tag F725, Staffing), counsel for CMS confirmed that CMS did not address this deficiency in its briefing. Therefore, the sole immediate jeopardy deficiency stemming from the survey at issue is the deficiency cited under 42 C.F.R. § 483.80.”).  The sole deficiency I consider for purposes of assessing the reasonableness of the CMP imposed is the infection prevention and control deficiency cited under 42 C.F.R. § 483.80(a)(1), (2), (4); (e), (f).  

**A skilled nursing facility is required to establish and maintain an infection prevention and control program. **

Pursuant to section 1819(d)(3) of the Act, Sanitary and Infection Control and Physical Environment, 42 U.S.C. § 1395i-3(d)(3), a skilled nursing facility must establish and maintain an infection prevention and control program to provide “a safe, sanitary, and comfortable environment in which residents reside and to help prevent the development and transmission of disease and infection.”  In furtherance of this statutory requirement, 42 C.F.R. § 483.80(a)(1), (2), (4); (e), (f) (Tag F-880) requires skilled nursing facilities to establish and maintain an infection prevention and control program that is designed to provide a safe, sanitary, and comfortable environment that helps to prevent the development and transmission of communicable diseases and infections. 

As relevant for purposes of this decision, a facility’s infection prevention and control program must include “[a] system for preventing, identifying, reporting, investigating, and controlling infections and communicable diseases for all residents, staff, volunteers, visitors, and other individuals providing services . . . based upon the facility assessment . . . and . . . national standards.”  42 C.F.R. § 483.80(a)(1).  Additionally, a facility must have written standards, policies, and procedures for its infection prevention and control program that include “[s]tandard and transmission-based precautions to be followed to prevent spread of infections.”  42 C.F.R. § 483.80(a)(2)(iii).  And pursuant to 42 C.F.R. § 483.80(e), facility staff “must handle, store, process, and transport linens so as to prevent the spread of infection.”  The Departmental Appeals Board (DAB) has explained that the regulation, as currently stated in 42 C.F.R. § 483.80(a)(2)9, “can only reasonably be interpreted as requiring not just that an infection control policy exist, but also that the policy be followed.”  *Heritage House of Marshall Health & Rehab. Ctr.*, DAB No. 2566 at 12 (2014).  At the outset of the COVID-19 pandemic, CMS plainly stated, “[t]o ensure health and safety, [it] . . . expects healthcare staff and surveyors . . . to comply with basic infection control practices.”  P. Ex. 12 at 2 (CMS Memorandum QSO-20-09-ALL, issued February 6, 2020).  CMS further stated that it “strongly urges the review of CDC’s guidance and encourages facilities to review their own infection prevention and control policies and practices to prevent the spread of infection.”  P. Ex. 12 at 1.  The following month CMS urged that “[f]acility staff should regularly monitor the CDC website for

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information and resources.”  P. Ex. 19 at 1 (CMS Memorandum QSO-20-14-NH, issued March 13, 2020). 

During the course of the survey, the CDC updated its recommendations for infection prevention and control for patients with COVID-19 or suspected COVID-19 in a healthcare setting.  P. Ex. 28.  The CDC’s recommendations included screening all visitors, requiring patients to wear a mask whenever they were outside their room, and that healthcare personnel “wear a facemask at all times while they are in the healthcare facility.”  P. Ex. 28 at 1-4. 

In guidance issued in May 2021, the CDC reported that “[i]nfectious exposures to respiratory fluids carrying [the COVID-19 virus] occur in three principal ways,” specifically: 
                            - Inhalation of air carrying very small fine droplets and aerosol particles that contain infection virus, with the greatest risk within 3-6 feet of an infectious source. 
                            - “Splashes” and “sprays” in exhaled droplets and particles onto exposed mucous membranes. 
                            - Touching mucous membranes with hands soiled by respiratory fluids containing virus or from touching inanimate surfaces contaminated with virus. 

P. Ex. 60 at 1-2. 

**The facility has infection prevention and control policies.  **

The facility has a policy entitled, “Pandemic Influenza, Infection Control Measures During.”  CMS Ex. 3 at 1.  The policy states that “[e]arly prevention of influenza outbreak consists of . . . [i]solation of infected residents in private rooms or cohort units[,] [u]se of appropriate barrier precautions during resident care[,] and [r]estriction of visitors who have been exposed to or are symptomatic of influenza.”  CMS Ex. 3 at 1.  The policy requires, in the event pandemic influenza is detected in the geographic area of the facility, that staff will be trained to screen visitors for “respiratory symptoms of pandemic influenza.”  CMS Ex. 3 at 1.  Additionally, the policy states, “If an outbreak of pandemic influenza occurs within the facility, adherence to standard and transmission-based precautions and other infection control measures will be implemented according to the most current CDC recommendations for pandemic influenza.”  CMS Ex. 3 at 1. 

Petitioner’s Infection Prevention and Control Program policy states that “[i]mportant facets of infection prevention include . . . following established general and disease-specific guidelines such as those of the [CDC].”  CMS Ex. 5 at 2.

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**CMS has met its prima facie burden with respect to Petitioner’s noncompliance regarding infection prevention and control cited as 42 C.F.R. § 483.80(a)(1), (2), (4); (e), (f), and Petitioner has not shown that it was in substantial compliance with this participation requirement. **

Pursuant to 42 C.F.R. § 483.80, Petitioner was required to “establish and maintain an infection prevention and control program designed to provide a safe, sanitary, and comfortable environment and to help prevent the development and transmission of communicable diseases and infections.”  “Before the ALJ, CMS must bear its initial burden of going forward with evidence related to disputed findings that is sufficient (together with any undisputed findings and relevant legal authority) to establish a prima facie case of noncompliance.”  *Mercy Home Care, Sioux City*, DAB No. 3044 at 16 (2021) (citing *Evergreene Nursing Care Ctr.*, DAB No. 2069 at 7 (2007)).  “‘If CMS makes this prima facie showing,’ the facility ‘must carry its ultimate burden of persuasion by showing, by a preponderance of the evidence, on the record as a whole, that it was in substantial compliance during the relevant period.’”  *Id.*at 16-17.

**A surveyor documented three occasions on which Petitioner did not screen visitors upon entry into the facility. **

One of the surveyors, Ms. Myers, reported that Petitioner’s staff “fail[ed] to screen visitors on” April 11 (6:43 am), April 15 (9:58 pm), and April 17, 2020 (4:50 am).  CMS Ex. 24 at 2; *see*CMS Ex. 1 at 35, 39, 42.  Ms. Myers referenced Petitioner’s policy requiring screening of all visitors at entry points during a pandemic influenza outbreak.  CMS Ex. 24 at 2; *see*CMS Ex. 3 at 1.  Petitioner has not disputed that it did not screen visitors on these occasions.  To the contrary, Petitioner, without any citation to authority or the evidentiary record, argues that, by the time of the survey, it “had few if any off-hours visitors other than the Surveyors, and CMS *specifically required*facilities to allow Surveyors to enter, screened or not, *because the SSA was screening surveyors, and so facilities could presume they were ‘low risk.’”*P. Post-Hrg. Br. at 29 (emphasis in original). 

As previously discussed, Petitioner’s policy unquestionably requires the screening of visitors.  CMS Ex. 3 at 1 (“If an outbreak of pandemic influenza occurs within the facility, adherence to standard and transmission-based precautions and other infection control measures will be implemented according to the most current CDC recommendations for pandemic influenza.”).  As early as March 2020, the CDC, in guidance to long-term care facilities regarding COVID-19, “[a] new respiratory disease,” instructed that allowing a visitor to enter the facility “should include careful screening of the visitor for fever or respiratory symptoms.”  P. Ex. 16 at 5.  In more comprehensive guidance updated in April 2020, which the CDC issued the following month, the CDC instructed health care facilities to “[l]imit points of entry to the facility and visitation

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hours to allow screening of all potential visitors,” to include screening for fever and COVID-19 symptoms.  P. Ex. 28 at 8-9. 

The DAB has explained that “[a] facility’s policies ‘may reflect [the] facility’s own judgment about how best to achieve compliance [with the participation requirements] and hence failure to comply with its own policies can support a finding that the facility did not achieve compliance with the regulatory standard.’”  *Heritage House of Marshall Health & Rehab.*, DAB No. 3035 at 10-11 (2021) (quoting *Bivins Mem’l Nursing Home*, DAB No. 2771 at 9 (2017), *appeal dismissed*, No. 17-60292 (5th Cir. Aug. 15, 2017)).  The DAB has further explained that a facility’s failure to comply with its own policy can be a deficiency.  *See Life Care Ctr. of Bardstown*, DAB No. 2233 at 21-22 (2009). 

Petitioner’s policy requiring the screening of visitors is consistent with CDC policy, and Petitioner has not claimed, much less offered evidence, that it screened visitors on the occasions reported by the surveyor.  Neither Petitioner’s nor CDC’s policy excludes state agency surveyors from visitor screening requirements, and Petitioner has not shown any error in CMS’s determination that the failure to screen visitors on April 11, 15, and 17 amounted to noncompliance with participation requirements. 

**On April 10, 2020, a surveyor observed a certified medication aide who had been crossing between a non-infected unit and an infected/presumed infected unit remove her personal protective equipment (PPE) gown and place it on the medication cart. **

A surveyor observed that a medication aide who had been in “full PPE” when exiting a “COVID-19 pending room, removed the gown in the hallway, rolled the gown up into a ball and placed the contaminated gown on top of the medication cart.”  CMS Ex. 1 at 33-34; *see*Tr. at 71 (“She went in – all those rooms were confirmed positive or presumed positive.  She came out of that room with her PPE on, which is presumed contaminated, and she wadded it up and put it on her medication cart and then rolled into the adjacent unit.”).  The surveyor explained that “[b]asic infection control practice would be to doff the contaminated gown before exiting the door, disposing of it properly, and then doing hand hygiene.”  Tr. at 71. 

In response, Petitioner argues that “neither the Surveyor nor CMS explains why placing this gown on this medication cart in this way exposed any resident to any potential for harm.”  P. Post-Hrg. Reply Br. at 12.  Without citing to any authority, Petitioner claimed that “because COVID-19 is not spread by contact, placing even an unrolled gown on the medication cart was not a plausible means of transmitting that virus – from the gown, to the cart, to a hand or medication, to a resident.”  P. Post-Hrg. Reply Br. at 12.  Not only does Petitioner not address that the medication aide failed to wash her hands immediately after she removed a contaminated gown, but Petitioner also fails to recognize that the CDC addressed the proper disposal of PPE, which not surprisingly does not involve

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balling up a contaminated gown and placing it on a medication cart that will be moving from a COVID-19 unit to a non-COVID-19 unit.  P. Exs. 16 at 4; 28 at 5 (addressing proper disposal of PPE and the need for handwashing “before putting on and after removing PPE.”); *see*CMS Ex. 3 at 1 (facility policy stating “adherence to standard and transmission-based precautions and other infection control measures will be implemented according to the most current CDC recommendations for pandemic influenza”); P. Ex. 10 at 24 (2007 CDC Guidance, stating that “[t]he outer, ‘contaminated’, side of the gown is turned inward and rolled into a bundle, and then discarded into a designated container for waste or linen to contain contamination.”); P. Ex. 29 at 4 (CDC Guidance on using PPE, updated August 19, 2020, stating, “Remove gown . . . Dispose in trash receptacle.”); P. Ex. 57 at 2 (testimony of Bryan W. McEachern, M.D., that “[t]he 2007 [CDC] Guidance provides that gowns . . . generally should be removed before leaving the ‘patient care area’ into ‘designated containers’ that are ‘convenient to the site of removal.’”).  Petitioner has not rebutted the prima facie evidence that disposing of contaminated PPE on a medication cart while crossing units amounts to noncompliance with infection prevention and control requirements. 

**On April 11, 2020, a surveyor observed a medication aide administer medications to a resident while wearing a mask under her chin.**

Despite a facility policy that requires adherence to CDC guidance (CMS Ex. 3 at 1), Petitioner did not ensure that its staff properly wore PPE, namely a mask, when in close contact with residents.  P. Exs. 16 at 7 (“Implement universal use of facemask for [healthcare personnel] while in the facility,” and instructing, “[i]f they leave their room, residents should wear a facemask. . . .”); 28 at 6 (“Put on an N95 respirator (or higher level respirator) or facemask (if a respirator is not available) before entry into the patient room or care area.”). 

On April 11, 2020, a certified medication aide was observed administering medications to a resident while wearing a mask under her chin.  CMS Ex. 1 at 35; *see*CMS Ex. 24 at 2-3 (testimony of Ms. Myers that she observed staff “fail to adhere to proper mask wearing in accordance with transmission based precautions [and] other infection control measures” on that occasion, among others).  On cross-examination, and in response to Petitioner’s question regarding the “risk of harm to a resident if a staff member’s face mask slips off her face,” Ms. Myers explained that “if the staff member’s face mask slips off their face they could be breathing out germs that we do not want.”  Tr. at 138.  Ms. Myers added that “[t]he CDC guidance said that masks must be on at all times while in the facility.”  Tr. at 138.  Petitioner has not disputed the factual basis for the cited deficiency (i.e., claim that the medication aide was, in fact, wearing a mask that covered her nose and mouth). 

Petitioner “agrees that both the CDC and CMS generally recommended, and [Petitioner’s] policies provided for, staff to wear masks at all times,” but apparently

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attempting to distinguish this guidance, stated that “the CDC also focused that recommendation in direct resident care.”  P. Post-Hrg. Reply Br. at 13.  In administering medication to a resident, the medication aide was undoubtedly providing direct resident care without a mask.  Petitioner has not rebutted prima facie evidence of its noncompliance with infection prevention and control requirements.  *See*P. Ex. 56 at 5-6 (testimony of Morgan J. Katz, MD that “[e]ffective isolation also depends on proper use of appropriate [PPE] to protect caregivers, and to reduce the likelihood that caregivers can transmit the virus,” and criticizing the surveyors’ citation of “PPE lapses not involving direct resident care”).  Petitioner was out of compliance with this requirement when its medication aide was not properly wearing a mask when administering medications to a resident. 

**On April 16, 2020, a surveyor observed staff cleaning a glucometer with an alcohol swab. **

On April 16, 2020, a surveyor (Ms. White) observed a nurse wipe a glucometer with an alcohol swab.  CMS Ex. 1 at 41; *see*CMS Ex. 23 at 5 (“Because alcohol is not effective for disinfecting glucometers, [staff] was not preventing the spread of infection.”).  Ms. White testified on cross-examination that the “standard of practice for years for common-use glucometers – it’s well-known that alcohol does not – is not effective against blood-borne viral pathogens, and so the proper way to clean a common-use glucometer is with a chemical wipe that’s known to be effective against viral blood-borne pathogens.”  Tr. at 78.  

Through the observations of the surveyor and the statement of deficiencies, CMS has met its prima facie burden that Petitioner was noncompliant with infection prevention and control requirements when its staff cleaned a common-use glucometer with an alcohol wipe.  While Petitioner points out the means to rebut this prima facie burden (i.e., produce evidence that the manufacturer recommended cleaning of the glucometer with an alcohol swab), it did not submit any evidence to rebut CMS’s prima facie burden.  Petitioner argues that CMS did not prove that the disinfection technique was inconsistent with the manufacturer’s recommendation for disinfecting the device.  Petitioner is mistaken; it needed to rebut CMS’s prima facie showing of noncompliance; yet it did not submit any evidence showing that cleaning the glucometer with an alcohol swab was an appropriate means of infection prevention and control as recommended by the device manufacturer.10

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***11. Although Petitioner disputes the determination that it was out of compliance with Medicare participation requirements, it does not dispute the duration of the cited noncompliance from April 10 through May 5, 2020, nor does it claim it returned to substantial compliance prior to May 5, 2020. ***

Once a facility is found to be out of substantial compliance, it remains so until it affirmatively demonstrates that it has achieved substantial compliance once again.  *Premier Living & Rehab Ctr.*, DAB No. 2146 at 23 (2008); *Lake City Extended Care Ctr.*, DAB No. 1658 at 12-15 (1998).  The burden is on the facility to prove that it is compliant with program requirements and not on CMS to prove that deficiencies continued to exist after they were discovered.  *Asbury Ctr. at Johnson City*, DAB No. 1815 at 19-20 (2002); *see also Grace Living Ctr. – Nw. OKC*, DAB No. 2633 at 3 (2015) (citing *Owensboro Place & Rehab. Ctr.*, DAB No. 2397 at 12 (2011)).  Noncompliance found during a survey is “presumed to continue until the facility demonstrates that it has achieved substantial compliance.”  *Taos Living Ctr.*, DAB No. 2293 at 20 (2009).  Absent any claim by Petitioner that it returned to substantial compliance sooner, I uphold the determination that noncompliance ended when the last resident departed the facility on May 5, 2020.  CMS Ex. 28. 

***12. Petitioner’s noncompliance amounted to immediate jeopardy to resident health and safety. ***

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.  I must uphold CMS’s determination as to the level of a facility’s substantial noncompliance (which includes an immediate jeopardy finding) unless it is “clearly erroneous.”  42 C.F.R. § 498.60(c).  The DAB directs that the “clearly erroneous” standard imposes on a facility a heavy burden to show no immediate jeopardy and has sustained determinations of immediate jeopardy where CMS presented evidence “from which ‘[o]ne could reasonably conclude’ that immediate jeopardy exists.”  *See, e.g.*, *Barbourville Nursing Home*, DAB No. 1962 at 11 (2005) (citing *Florence Park Care Ctr.*, DAB No. 1931 at 27-28 (2004)). 

Petitioner was noncompliant with infection prevention and control requirements, to include repeatedly failing to screen visitors, failing to properly dispose of PPE, failing to ensure staff wore a mask properly when administering medications to a resident, and failing to properly disinfect a glucometer in-between uses on different residents.  Many residents in the facility contracted COVID-19.  P. Br. at 19 (“By the time the last resident left the [facility] on May 5, 2020, about 100 residents and staff had tested positive for COVID-19, 55 residents had been hospitalized, and tragically, 21 died.”). 

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Petitioner cites the testimony of its witnesses (P. Exs. 56-58) to support its claim that any cited deficiencies involving infection prevention and control do not amount to immediate jeopardy.  However, none of these witnesses provided clear evidence to rebut the determination of immediate jeopardy.  In fact, the witnesses, to some extent, support the immediate jeopardy determination.  For example, Dr. Katz testified that “[e]ffective isolation also depends on proper use of appropriate [PPE] to protect caregivers, and to reduce the likelihood that caregivers can transmit the virus.”  P. Ex. 56 at 5.  Dr. McEachern provided similar testimony on this point, stating,

[t]hat is why proper PPE use is important.  At least in theory, staff who are properly garbed with appropriate PPE can provide care to a COVID-19-positive resident:  doff the PPE, sanitize hands, and don new PPE; and then provide care to a COVID-19-negative resident with minimal risk of transmitting disease. 

P. Ex. 57 at 3. 

And Dr. Grabowski “express[ed] no specific opinion on any of the individual deficiencies cited in this case,” yet reported that “the CDC recognized early on that COVID-19 was spread almost entirely by direct mucous membrane contact with infected respiratory droplets over a very short distance, less than six feet, and that indirect, and contact or fomite transmission, are unlikely.”  P. Ex. 58 at 3, 6.  Each of these opinions *supports*an immediate jeopardy determination for the instance when a medication aide was not wearing a mask over her nose and mouth when she administered  medications to a resident.  *See*CMS Ex. 1 at 35 (cited deficiency involving a medication aide who administered medications to a resident “while wearing her mask under her chin”). 

While Petitioner claims CMS played “gotcha” by citing the facility’s failure to repeatedly screen a surveyor when she entered the facility, a premise upon which I disagree, the facility’s policy, which mirrored CDC guidance, required screening of visitors.  P. Post-Hrg. Br. at 29.  The failure to screen visitors who may exhibit symptoms of COVID-19 and prevent them from entering the facility, where they can spread disease, certainly caused a likelihood of serious harm. 

None of Petitioner’s witnesses opined that COVID-19 *cannot* be transmitted by surfaces, and the CDC, even long after the survey, maintained that the COVID-19 disease can be transmitted through surfaces and that handwashing was an effective means of infection prevention and control.  *See*P. Ex. 60 at 2-3 (May 2021 CDC guidance addressing transmission through hands and soiled surfaces).  The improper disposal of a soiled gown on a medication cart that traveled between units, combined with the failure of the medication aide to wash her hands after doffing the gown, unmistakably supports a

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likelihood of serious harm under such a practice.  Further, Petitioner has not shown that the determination of immediate jeopardy is clearly erroneous. 

And finally, the improper disinfection of a glucometer places residents who are tested with the same glucometer at risk for bloodborne illness.  Exposing residents to bloodborne illness exposes them to a likelihood of serious harm, especially if the improper disinfection practice had continued without the intervention of the survey team, and the deficiency amounts to immediate jeopardy. 

***13. A per-day CMP of $6,808, which is the minimum allowable per-day CMP for immediate jeopardy noncompliance, is a reasonable enforcement remedy for the immediate jeopardy noncompliance. ***

If a facility is not in substantial compliance with program requirements, CMS has the authority to impose one or more of the enforcement remedies listed in 42 C.F.R. § 488.406, to include a CMP.  The DAB has explained that “it is settled law that ALJ review of the reasonableness of CMP amounts imposed by CMS is *de**novo*.”  *Fireside Lodge Ret. Ctr., Inc.*, DAB No. 2794 at 19 (2017).  I consider whether the evidence supports a finding that the amount of the CMP is at a level reasonably related to an effort to produce corrective action by a provider with the kind of deficiencies found, and in light of the above factors. 

I am neither bound to defer to CMS’s factual assertions, nor free to make a wholly independent choice of remedies without regard for CMS’s discretion.  *See, e.g., Barn Hill Care Ctr.*, DAB No. 1848 at 21 (2002).  The DAB has explained that “[t]he determination of whether a CMP amount is reasonable is a conclusion of law, not a finding of fact.”  *Cedar Lake Nursing Home,*DAB No. 2344 at 12 (2010). 

The regulations specify that a CMP that is imposed against a facility on a per-day basis will fall into one of two ranges.  42 C.F.R. §§ 488.408, 488.438.  The upper range of a CMP, $3,050 per day to $10,000 per day, as adjusted annually under 45 C.F.R. pt. 102, is reserved for deficiencies that pose immediate jeopardy to a facility’s residents and, in some circumstances, for repeated deficiencies.  42 C.F.R. § 488.438(a)(1)(i), (d)(2).  The lower range of CMP, $50 to $3,000 per day, as adjusted annually under 45 C.F.R. pt. 102, is reserved for deficiencies that do not pose immediate jeopardy, but either cause actual harm to residents, or cause no actual harm but have the potential for causing more than minimal harm.  42 C.F.R. § 488.438(a)(1)(ii).  The inflation-adjusted per-day CMP range applicable to this case is $6,808 to $22,320 for the immediate jeopardy noncompliance.  45 C.F.R. § 102.3 (2020).  In assessing the reasonableness of a CMP amount, an ALJ looks at the per-day amount, rather than the total accrued CMP.  *See Kenton Healthcare, LLC*,DAB No. 2186 at 28 (2008).  Pursuant to 42 C.F.R. § 488.408(g)(2), a facility cannot appeal CMS’s choice of a remedy, and an appeal of a CMP is limited to review based on the regulatory factors set forth at 42 C.F.R. §§ 488.438(f) and 488.404(a)-(c). 

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*See, e.g.*,*Senior Rehab. & Skilled Nursing Ctr.*,DAB No. 2300 at 19-20 (2010).  In this case, CMS imposed a per-day CMP of $10,920 for immediate jeopardy noncompliance. 

As previously discussed, CMS partially based its finding of immediate jeopardy noncompliance on an appealed deficiency that it declined to address in its briefing.  CMS Ex. 26 at 2; *see*CMS Pre-Hrg. Br. (limiting arguments to the immediate jeopardy deficiency cited for infection prevention and control, and not addressing the other cited immediate jeopardy deficiency for staffing).  Because CMS based the CMP on *two*immediate jeopardy deficiencies and only one of these deficiencies supports the CMP imposed, a reduction in the CMP from $10,920 to the minimum per-day amount of $6,808, a less than 50 percent reduction, for immediate jeopardy noncompliance is appropriate.  *See*42 C.F.R. §§ 488.408(e)(1)(iii), 488.438(a)(1)(i); 45 C.F.R. § 102.3 (2020).  

### IV.    Conclusion

For the reasons discussed above, I find that the facility was not in substantial compliance with the Medicare participation requirements beginning on April 10, 2020, and continuing through the date of departure of the last remaining resident on May 5, 2020, and CMS’s determination of immediate jeopardy to resident health and safety is not clearly erroneous.  Because CMS has supported only one of two immediate jeopardy deficiencies, I uphold a per-day CMP of $6,808 for immediate jeopardy noncompliance. 

### Endnotes

1  Petitioner did not challenge other remedies imposed, to include the termination of its Medicare provider agreement. 

2  The per-day CMP ranges applicable to this case are $6,808 to $22,320 for immediate jeopardy-level deficiencies and $112 to $6,695 for deficiencies that do not constitute immediate jeopardy.  45 C.F.R. § 102.3 (2020).  

3  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.  

4  Scope and severity levels are used by CMS and state survey agencies when selecting remedies.  The scope and severity level is designated by letters A through L.  CMS Pub. 100-7, State Operations Manual (SOM), ch. 7, § 7400.3.1 (Matrix for Scope & Severity) (Rev. 185, eff. Nov. 16, 2018); *see also*42 C.F.R. § 488.408.  As relevant here, a scope and severity level of “L” indicates widespread immediate jeopardy to resident health or safety. 

5  CMS also informed Petitioner that it would lose approval to conduct a Nurse Aide Training and Competency Evaluation Program, and that continued noncompliance would result in a denial of payment for new admissions, effective April 29, 2020, and termination of its Medicare provider agreement effective May 17, 2020.  CMS Ex. 26 at 2-3.  Because Petitioner only challenges the remedy of the CMP, I limit discussion herein to the reasonableness and duration of the per-day CMP.  

6  CMS had already filed an Exhibit 28; I admitted CMS Ex. 28 into the evidentiary record on June 21, 2021.  CMS should have marked this exhibit as CMS Ex. 29 and requested leave to file CMS Ex. 29. 

7  I note that CMS filed a brief in response to the July 26, 2021 order, so it is frankly implausible that CMS did not see this order.  In fact, the portion of the order directing CMS to file the additional evidence is entirely in bold font. 

8  Findings of fact and conclusions of law are in bold and italics

9  The Board referenced 42 C.F.R. § 483.65 in its decision; this regulation was later redesignated as 42 C.F.R. § 483.80. 

10  I recently addressed a facility’s noncompliance with the infection prevention and control participation requirement based on its failure to disinfect a glucometer between uses on different residents, and I found that the cited deficiency amounted to immediate jeopardy to resident health and safety.  *See Sun West Choice Healthcare & Rehab.*, DAB No. CR6254 (2023). 

Leslie C. RogallAdministrative Law Judge