Jamestown Nursing and Rehab, LLC, DAB CR6722 (2025)

DECISION

Petitioner, Jamestown Nursing and Rehab, LLC, challenges the determination by Respondent, the Centers for Medicare & Medicaid Services (CMS), that it was not in substantial compliance with a Medicare program participation requirement.  Petitioner also challenges as unreasonable CMS’s imposition of a $5,000 per-instance civil money penalty (CMP). 

As explained herein, I affirm CMS’s determination that Petitioner did not implement its infection control policy.  However, Petitioner has established this noncompliance was not substantial.  CMS did not have the authority to impose a $5,000 CMP, which I overturn.  

I. Background

Petitioner is a skilled nursing facility located in Rogers, Arkansas that participates in the Medicare program.  CMS Exhibit (Ex.) 1 at 1.  Surveyors from the Arkansas Department of Human Services (ADHS or state agency) conducted a COVID-19 focused infection control survey at Petitioner’s facility from September 14 to September 16, 2020, and as a result, cited Petitioner for failing to substantially comply with the infection prevention and control requirements set forth at 42 C.F.R. § 483.80(a)(1), (a)(2), (a)(4), (e), and (f) (Tag F880).  CMS Ex. 2 at 1-5; CMS Ex. 6 at 1.  

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CMS cited this deficiency at scope and severity level1 “D,” meaning an isolated instance of noncompliance that presents no actual harm but has the potential for more than minimal harm that does not amount to immediate jeopardy to resident health and safety.  CMS Ex. 1 at 1. 

Based on this deficiency finding, CMS notified Petitioner on December 1, 2020 that it would impose a $5,000 per-instance CMP.  Id. at 2.  CMS also advised Petitioner it had adopted ADHS’s finding that Petitioner returned to substantial compliance on October 31, 2020.  Id. at 1.  As a result, CMS rescinded the termination action and denial of payment for new admissions (DPNA) it had previously warned would occur if Petitioner did not return to compliance.  Id. at 1, 3.  

Petitioner timely sought a hearing before an Administrative Law Judge (ALJ) in the Civil Remedies Division to challenge CMS’s determination of noncompliance and imposition of the $5,000 per‑instance CMP, resulting in my designation to hear and decide this case.  I issued an Acknowledgment Letter and Standing Pre‑hearing Order (Pre-hearing order) that established a briefing schedule and directed the parties to file pre-hearing submissions that included written direct testimony for all proposed witnesses, proposed exhibits, and pre-hearing briefs. 

CMS filed a pre-hearing brief (CMS Br.) and 11 proposed exhibits (CMS Exs. 1-11), including written direct testimony for two witnesses.  Petitioner filed a pre‑hearing brief (P. Br.) and 17 proposed exhibits (P. Exs. 1-17), including written direct testimony of two witnesses.  CMS requested to cross-examine Petitioner’s witnesses.  I therefore scheduled a hearing in this matter that took place by videoconference on February 1, 2022.  The parties subsequently filed closing briefs (CMS Closing Br., P. Closing Br.). 

II. Admission of Exhibits

Neither party objected to the opposing party’s proposed exhibits.  I therefore admit CMS Exhibits 1 through 11 and Petitioner Exhibits 1 through 17 into the record. 

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III. Issues

The issues presented are: 

1. Whether Petitioner was in substantial compliance with 42 C.F.R. § 483.80(a)(1), (a)(2), (a)(4), (e), and (f) (Tag F880);
2. If Petitioner was not in substantial compliance with Medicare participation requirements, whether the $5,000 per-instance CMP was reasonable.

IV. Jurisdiction

I have jurisdiction to hear and decide this case.  Soc. Sec. Act (Act) §§ 1128A(c)(2), 1819(h)(2)(B)(ii) (codified at 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).

V. Legal Authority for the Imposition of Penalties

Skilled nursing facilities like Petitioner must meet requirements set forth by the Act to participate in the Medicare program.  The Secretary of the U.S. Department of Health and Human Services (Secretary) is authorized to promulgate regulations implementing those statutory provisions.  Act § 1819 (42 U.S.C. § 1395i-3).  These regulations are found at 42 C.F.R. parts 483 and 488. 

A skilled nursing facility must maintain substantial compliance with program requirements to participate as a provider in the program.  To be in substantial compliance, a facility’s deficiencies (failures to meet a participation requirement) may “pose no greater risk to resident health or safety than the potential for causing minimal harm.”  42 C.F.R. § 488.301 (defining “Deficiency” and “Substantial compliance”). 

The Secretary contracts with state agencies to conduct periodic surveys to determine whether skilled nursing facilities are in substantial compliance with participation requirements.  Act §§ 1864(a) (42 U.S.C. § 1395aa(a)), 1819(g) (42 U.S.C. § 1395i-3(g)); 42 C.F.R. §§ 488.10(a), 488.308.  State agency surveyors report findings in a “Statement of Deficiencies” that identifies each deficiency and an assessment of its seriousness based on its scope (whether it is isolated, part of a pattern, or widespread) and severity (no actual harm with the potential for minimal harm, no actual harm with the potential for more than minimal harm, actual harm that is not immediate jeopardy, and immediate jeopardy to resident health and safety).  42 C.F.R. § 488.404(b); State Operations Manual Rev. 185 Ch. 7 § 7400.3.1.  Immediate jeopardy refers to noncompliance that “has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident.”  42 C.F.R. § 488.301.  

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The Act authorizes the Secretary to impose enforcement remedies against skilled nursing facilities that do not comply with the participation requirements.  Act § 1819(h)(2) (42 U.S.C. § 1395i-3(h)(2)).  The Act specifies the Secretary may impose CMPs if a facility is not in substantial compliance.  Act § 1819(h)(2)(B)(ii) (42 U.S.C. § 1395i-3(h)(2)(B)(ii)); see also 42 C.F.R. § 488.406.  Regulations implemented under this authority permit CMS to impose either a per-day CMP for the number of days a facility is out of substantial compliance or a per-instance CMP for each instance of noncompliance.  42 C.F.R. § 488.430(a). 

CMS imposed a per-instance CMP in this case.  A per-instance CMP initially ranged from $1,000 to $10,000.  42 C.F.R. § 488.438(a)(2).  However, Congress permitted CMS to increase CMP amounts to account for inflation beginning August 1, 2016.  Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, Pub. L. No. 114-74, 129 Stat. 584, 599; see also 45 C.F.R. § 102.3 (Table).  The adjusted CMP amounts apply to deficiencies cited after November 2, 2015.  81 Fed. Reg. 61,538 (Sep. 6, 2016).  When CMS imposed the CMP at issue here, a per-instance CMP could range from $2,233 to $22,320.  42 C.F.R. § 102.3 (Table); 85 Fed. Reg. 2,869, 2,879-80 (Jan. 17, 2020). 

A facility against whom CMS has imposed a CMP may request a hearing before an ALJ to challenge the basis for the deficiency findings as well as the reasonableness of the CMP.  Act §§ 1128A(c)(2) (42 U.S.C. § 1320a-7a(c)(2)), 1819(h)(2)(B)(ii) (42 U.S.C. § 1395i(h)(2)(B)(ii)); 42 C.F.R. §§ 488.408(g), 488.434(a)(2)(viii), 498.3(b)(13).  However, CMS’s choice of remedies and the factors it considered when deciding upon remedies are not subject to review.  42 C.F.R. § 488.408(g)(2). 

VI. Burdens of proof and persuasion

In adjudications proceeding under the Administrative Procedures Act (APA), Congress established that “the proponent of a rule or order has the burden of proof[,]” except where otherwise provided by statute.  5 U.S.C. § 556(d).  The Act does not “otherwise provide[]” for allocation of the burden of proof or the quantum of evidence necessary to meet that burden in this type of proceeding.  It would therefore be reasonable to conclude that CMS, the agency that propounded the regulations implementing its enforcement authority under the Act, bears the burden of proof and persuasion to justify imposition of penalties authorized by the Act. 

The Departmental Appeals Board has nevertheless imposed a burden-shifting regime in cases involving the imposition of enforcement penalties against providers whose appeals are adjudicated under 42 C.F.R. Part 498.  Hillman Rehab. Ctr., DAB No. 1611 (1997), aff’d, Hillman Rehab. Ctr. v. U.S. Dep’t of Health & Human Servs., No. Civ. A. 98-3789 (GEB), 1999 WL 34813783 (D.N.J. May 13, 1999); VITAS Healthcare Corp. of Calif., DAB No. 1782 at 4 (2001); Cross Creek Health Care Ctr., DAB No. 1665 (1998) (applying the burden-shifting regime to cases involving skilled nursing facilities);

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Batavia Nursing & Convalescent Inn, DAB No. 1911 (2004), aff’d sub nom., Batavia Nursing & Convalescent Ctr. v. Thompson, 143 F. App’x 664 (6th Cir. 2005). 

Under that regime, CMS has the burden to come forward with evidence sufficient to make a prima facie showing2  it had a basis to impose a penalty.  In Hillman, an appeal by a rehabilitation center of its termination as a provider to the Medicare program by the Health Care Finance Administration (CMS’s predecessor agency), the Board identified the elements it believed necessary for CMS to make such a showing: 

[CMS] must identify the legal criteria to which it seeks to hold a provider.  Moreover, to the extent that a provider challenges [CMS’s] findings, [CMS] must come forward with evidence of the basis for its determination, including the factual findings on which [CMS] is relying and, if [CMS] has determined that a condition of participation was not met, [CMS’s] evaluation that the deficiencies found meet the regulatory standard for a condition-level deficiency. 

DAB No. 1611 at 8. 

Once CMS makes a prima facie showing of noncompliance, the Board held the facility bears “the ultimate burden of persuasion” and can only prevail if it proves, by a preponderance of the evidence of record, that it substantially complied with statutory and regulatory requirements.  Id. at 7. 

Subsequently, a skilled nursing facility appealing CMS’s imposition of a CMP argued burden-shifting would be improper in hearings proceeding under the APA.  Batavia Nursing & Convalescent Inn, DAB No. 1911 (2004), aff’d sub nom., Batavia Nursing & Convalescent Ctr. v. Thompson, 143 F. App’x 664 (6th Cir. 2005). 

The Board rejected this claim, explaining the Supreme Court approved placing the burden of proof “on the claimant for governmental benefits when evidence is evenly balanced” because the party seeking the benefit, including a “non-monetary benefit or privilege,” would, in that context, be “the proponent of the rule or order.”  Batavia Nursing, DAB No. 1911 at 10 (citing Director, OWCP v. Greenwich Collieries, 512 U.S. 267, 276 (1994); U.S. Steel Corp. v. Train, 556 F.2d 822, 834 (7th Cir. 1977) (the

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applicant for a permit to discharge pollutants is a “proponent”); Day v. NTSB, 414 F.2d 950, 952 (5th Cir. 1969) (finding it appropriate to place the burden of proof on a pilot seeking certification of fitness to fly). 

The Board reasoned that by appealing the penalties imposed by CMS, Batavia Nursing in essence sought “from the government an order certifying that it is in substantial compliance with [skilled nursing facility] requirements, so that it may continue to participate in the Medicare program with no restrictions on payment.”  DAB No. 1911 at 10.  The Board therefore concluded it reasonable to place the burden of proof on Batavia to show its return to substantial compliance.  Id. 

The legitimacy of the burden-shifting regime thus rests largely on the Board’s characterization of facilities as proponents of a rule or order because they seek a certification of substantial compliance with Medicare program participation rules, even though the jurisdiction of ALJs and the Board to hear such challenges is limited exclusively to circumstances where CMS opts to impose a penalty.3  42 C.F.R. § 488.408(g)(1) (“A facility may appeal a certification of noncompliance leading to an enforcement remedy.”); 42 C.F.R. § 498.3(b)(13); Columbus Park Nursing & Rehab. Ctr., DAB No. 2316 at 7 (2010) (a facility cannot contest survey deficiency findings unless CMS has imposed a remedy). 

To date, federal district and circuit courts have declined to disturb the Board’s burden-shifting regime on due process or other grounds.  See, e.g., Hillman Rehab. Ctr., DAB No. 1611 (1997), aff’d, Hillman Rehab. Ctr. v. U.S. Dep’t of Health & Human Servs., No. Civ. A. 98-3789 (GEB), 1999 WL 34813783 (D.N.J. May 13, 1999); Fairfax Nursing Home, Inc., DAB No. 1794 (2001), aff’d, Fairfax Nursing Home v. Dep’t of Health & Human Servs., 300 F.3d 835 (7th Cir. 2002), cert. denied, 2003 WL 98478 (Jan. 13, 2003); Batavia Nursing & Convalescent Inn, DAB No. 1911 (2004), aff’d sub nom., Batavia Nursing & Convalescent Ctr. v. Thompson, 143 F. App’x 664 (6th Cir. 2005).  

However, the Supreme Court has since examined the scope of the Secretary’s rulemaking authority in the context of Medicare reimbursement and held that under section 1871 of the Act, the Secretary must comply with notice-and-comment rulemaking under the APA to impose any requirements upon regulated entities which constituted a change in a

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substantive legal standard.  Azar v. Allina Health Servs., 587 U.S. 566, 139 S. Ct. 1804 at 1809-14 (2019). 

The Court has also formally repudiated its longstanding interpretive rule, known as Chevron deference, which required courts reviewing agency actions to defer to agencies’ interpretation of their statutory mandate where the language of the statute in question was ambiguous.  See Loper Bright Enters. v. Raimondo, 603 U.S. 369, 144 S. Ct. 2244 (2024); see also Hillman Rehab. Ctr., DAB No. 1611 at 17-20 (justifying burden-shifting in part by noting its consistency with the “long-standing interpretation” of the Act and its implementing regulations by the Board’s predecessor body). 

It remains to be seen whether federal courts will consider the Board’s burden-shifting regime a “change in a substantive legal standard” under the Allina holding or, in the absence of Chevron deference, more broadly reject the Board’s interpretation of section 7 of the APA to identify entities challenging enforcement actions taken by the government as proponents of an order or rule.  Until such judicial scrutiny demands otherwise, and absent modification of the Act or CMS’s implementing regulations, I apply the Board’s burden-shifting regime. 

VII. Discussion

A. Legal framework for Infection Prevention and Control

The Act and its implementing regulation require facilities like Petitioner to “[e]stablish and maintain an infection control program designed to provide a safe, sanitary, and comfortable environment in which residents reside and to help prevent the development and transmission of disease and infection[.]”  42 U.S.C. § 1395i-3(d)(3)(A); 42 C.F.R. § 483.80.  At minimum, a facility’s infection control policy must satisfy the following requirements:  

(a)  Infection prevention and control program.  The facility must establish an infection prevention and control program (IPCP) that must include, at a minimum, the following elements:  

(1)  A system for preventing, identifying, reporting, investigating, and controlling infections and communicable diseases for all residents, staff, volunteers, visitors, and other individuals providing services under a contractual arrangement based upon the facility assessment conducted according to § 483.70(e) and following accepted national standards;
(2)  Written standards, policies, and procedures for the program, which must include, but are not limited to:

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(i)  A system of surveillance designed to identify possible communicable diseases or infections before they can spread to other persons in the facility;
(ii)  When and to whom possible incidents of communicable disease or infections should be reported;
(iii)  Standard and transmission-based precautions to be followed to prevent spread of infections;
(iv)  When and how isolation should be used for a resident; including but not limited to:  

(A)  The type and duration of the isolation, depending upon the infectious agent or organism involved, and 
(B)  A requirement that the isolation should be the least restrictive possible for the resident under the circumstances.  

(v)  The circumstances under which the facility must prohibit employees with a communicable disease or infected skin lesions from direct contact with residents or their food, if direct contact will transmit the disease; and
(vi)  The hand hygiene procedures to be followed by staff involved in direct resident contact. 

                              *          *          *

(4)  A system for recording incidents identified under the facility’s IPCP and the corrective actions taken by the facility. 

                                    *          *          *

(e)  Linens.  Personnel must handle, store, process, and transport linens so as to prevent the spread of infection.  
(f)  Annual review.  The facility will conduct an annual review of its IPCP and update their program, as necessary. 

42 C.F.R. § 483.80(a)(1), (a)(2), (a)(4), (e), (f). 

Beyond prescribing the presence of these elements, the regulation does not mandate specific standards and measures but instead grants facilities discretion to develop and implement infection control protocols consistent with “accepted national standards” for infection control.  42 C.F.R. § 483.80(a)(1); Golden Living Ctr. – Superior, DAB No.

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2768 at 7-8 (2017).  Upon establishing such policies and protocols, a facility must implement those protocols and assure they are effective.  Id.  A facility is not in substantial compliance with participation requirements when it fails to follow standard precautions and isolation control procedures specified in its own infection control policies.  Heritage House of Marshall Health & Rehab. Ctr., DAB No. 2566 at 12-13 (2014). 

B. CDC Guidance

At the outset of the COVID-19 pandemic, CMS encouraged nursing homes to rely on information and resources provided by the Centers for Disease Control and Prevention (CDC).4   Ctrs. for Medicare & Medicaid Servs., Guidance for Infection Control and Prevention of Coronavirus Disease 2019 (COVID-19) in Nursing Homes (REVISED) at 1, available at https://www.cms.gov/files/document/3-13-2020-nursing-home-guidance-covid-19.pdf (last rev. Mar. 13, 2020). 

On March 29, 2021, the CDC issued guidance concerning infection prevention and control practices in nursing homes, entitled “Interim Infection Prevention and Control Recommendations to Prevent SARS-CoV-2 Spread in Nursing Homes.”  CMS Ex. 9.  This guidance merged and updated previous guidance from the CDC – “Responding to COVID-19 in Nursing Homes” and “Performing Facility-wide SARS-CoV-2 Testing in Nursing Homes,” both issued in May 2020.5  Id. at 1; see also P. Exs. 9, 10.  

In the former guidance, the CDC recommended placing newly admitted residents of unknown COVID-19 status in either a single room or in a separate observation area.  P. Ex. 10 at 3.  The CDC advised that staff caring for residents wear a respirator or facemask, eye protection, gloves, and a gown.  Id.  While the CDC acknowledged the utility of testing such residents to ensure those who tested positive for COVID-19 could be identified, it warned that a negative test on admission did not mean a resident had not been exposed and would not develop an infection.  Id.  Accordingly, the CDC recommended monitoring newly admitted residents “for evidence of COVID-19 for 14 days after admission and cared for using all recommended COVID-19 PPE.”  Id.  

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In the latter guidance, the CDC defined healthcare personnel as “all paid and unpaid persons serving in healthcare settings who have the potential for direct or indirect exposure to patients or infectious materials . . . .”  P. Ex. 9 at 11.  It emphasized to these workers that their potential exposure to the COVID-19 virus was not limited to direct patient care interactions.  Id. at 4.  The CDC maintained that on admission, facilities should place residents suspected to have a COVID-19 infection in single rooms with the door closed and a dedicated bathroom.  Id. at 6.  The CDC recommended healthcare workers wear a respirator or facemask, a gown, gloves, and eye protection to enter the room of an isolated patient.  Id. at 7.  

The CDC reminded facilities to manage laundry in accordance with routine procedures.  Id. at 9.  In previously issued guidance, the CDC provided best practices for handling laundry in healthcare facilities that included:  wearing rubber gloves to handle soiled linen; to “[n]ever carry soiled linen against the body;” and to avoid transporting soiled linen by hand outside the patient area where it originated and instead use a clearly labeled leak-proof container like a bag or bucket.  P. Ex. 15 at 1. 

C. Petitioner’s infection control policy

Petitioner’s infection control policy required staff to use “Standard Precautions”6  at all times to care for residents.  CMS Ex. 3 at 1.  It required the use of “Transmission-based precautions”7  for residents “documented or suspected to have communicable diseases or infection that can be transmitted to others.”  Id.  The policy demanded staff place infected residents under isolation based on the type of infectious agent or organism.  Id.  The policy directed the duration of the period of isolation be determined by “the physician,” presumably the isolated resident’s attending doctor.  Id.  

Petitioner’s infection control policy does not explicitly incorporate the CDC’s guidelines concerning COVID-19-specific measures.  However, Petitioner has consistently taken the position that its infection control policy in fact does so, and its witnesses have confirmed that position.  P. Closing Br. at 8, citing Hearing Tr. at 28 (testimony of Director of Nursing (DON) Trina Steel agreeing Petitioner’s infection control policy incorporated the CDC’s COVID-19 guidance); see also Hearing Tr. at 12 (Petitioner’s expert witness Dr. Stillwell confirming “Yes, I believe the CDC Guidances were incorporated into [Petitioner’s] policies.”).  

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Accordingly, for purposes of this decision, I consider CDC guidelines publicly available at the time of the survey to be part of Petitioner’s infection control policy. 

D. Relevant Facts

Petitioner admitted Resident 1 on September 3, 2020 following a hospital stay for acute encephalopathy secondary to a urinary tract infection.  P. Ex. 4 at 1, 8.  Resident 1’s other diagnoses included acute kidney failure, muscle wasting and atrophy, osteoarthritis, and dementia.  Id. at 2.  As a newly admitted resident, the facility placed him on Transmission-based precautions.  CMS Ex. 5 at 4; see CMS Ex. 3 at 1. 

On September 15, 2020, Surveyor Regina Walker, R.N., observed Resident 1 in his isolation room, eating breakfast in bed with the room door open.  CMS Ex. 2 at 4; CMS Ex. 6 at 1; CMS Ex. 8 at 2.  The surveyor then witnessed Certified Nurse Aide (CNA) Sieara Phillips enter Resident 1’s room to take the resident’s meal tray without donning a gown.  CMS Ex. 6 at 1.  Surveyor Walker asked CNA Phillips if she was required to wear a gown to enter an isolation room, to which the nurse aide responded, “I didn’t know.”  Id.  

Surveyor Walker then interviewed DON Steel and asked her if staff were required to wear gowns to enter isolation rooms.  Id.  The nursing director responded “Yes.”  Id.  DON Steel confirmed the facility placed Resident 1 in quarantine for 14 days because he was newly admitted.  Id.  She also confirmed that the resident’s door should have been closed.  Id.  

Shortly thereafter, Surveyor Walker observed CNA Dezarea Sprinkle leave a resident’s room holding linens “in her arms against her chest.”  CMS Ex. 2 at 4-5; CMS Ex. 6 at 2; CMS Ex. 8 at 2.  The surveyor asked CNA Sprinkle if the linens she held were dirty.  CMS Ex. 2 at 5; CMS Ex. 6 at 2; CMS Ex. 8 at 2.  The nurse aide responded, “Yes, I was in a hurry I am sorry.”  CMS Ex. 6 at 2.  When asked, CNA Sprinkle confirmed she was supposed to transport dirty linens in a plastic bag but did not do so because she had been in a hurry and didn’t have one.  Id.  DON Steel confirmed to Surveyor Walker that staff could not carry dirty linens against their uniform because of the risk of cross-contamination.  CMS Ex. 2 at 5; CMS Ex. 6 at 3; CMS Ex. 8 at 2. 

E. CMS has not established Petitioner did not substantially comply with 42 C.F.R. § 483.80(a) (Tag F880). 

For the reasons set forth here, I conclude CMS met its prima facie burden to show Petitioner did not adequately implement its own infection control policy as it pertained to the use of PPE and the handling and transportation of contaminated linen in two instances.  However, Petitioner has established its failure to implement its PPE policy did not amount to more than a minimal risk of harm.  

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1. Petitioner did not implement its infection control policy concerning the use of PPE for newly admitted residents. 

CMS contends Petitioner did not implement its own infection control policy as it pertained to the use of PPE, specifically the CDC’s guidance to use Transmission-based precautions for newly admitted residents, which meant isolating them for a 14-day quarantine period and donning full PPE, including a gown, to provide care.  CMS Br. at 4, citing CMS Ex. 3; see also P. Ex. 10 at 3; Hearing Tr. at 12, 28.  CMS points to Surveyor Walker’s uncontroverted observation that a member of Petitioner’s staff, CNA Phillips, entered Resident 1’s isolation room without donning a gown.  See CMS Ex. 2 at 4-5; CMS Ex. 6 at 2. 

Petitioner responds that its staff followed the CDC’s guidelines, claiming the obligation to don a gown did not apply because CNA Phillips merely retrieved a tray from Resident 1’s room without coming into contact with the resident or his environment, meaning she did not provide “direct care” and thus complied with the Transmission-based precautions in effect for Resident 1.  P. Br. at 8, citing Hearing Tr. 23-24; see also P. Ex. 14 at 2-3. 

Petitioner’s argument fails because the CDC’s guidelines do not vary based on the tasks performed for a patient in isolation.  At this point in the COVID-19 pandemic, the CDC recommended placing newly admitted residents in isolation (and therefore under Transmission-based precautions) for 14 days, regardless of their COVID-19 test status.  P. Ex. 10 at 3.  During that time, the CDC’s protocol required use of N95 or better masks, eye protection, gloves, and gowns to provide patient care.  Id.  It did not suggest different criteria for the use of PPE depending on the nature of the care given to a resident.  Instead, the CDC observed that exposure to the COVID-19 virus was “not limited to direct patient care interactions” and accordingly advised facilities to require staff to wear “all recommended COVID-19 PPE,” which included a gown, to care for residents under observation like Resident 1.  P. Ex. 9 at 3, 4. 

Critically, the requirement to don PPE was not triggered by the provision of “direct care,” coming within six feet of an isolated patient, or making contact with the patient, as Petitioner contends, but whenever a health care provider entered the room of a patient subject to Transmission-based precautions.  Id. at 7 (health care personnel who “enter the room of a patient with suspected or confirmed SARS-CoV-2 infection should adhere to Standard Precautions and use a . . . gown . . . .”); id. at 8 (“Put on a clean isolation gown upon entry into the patient room or area.”).  There is no dispute Resident 1 was under Transmission-based precautions when Surveyor Walker observed CNA Phillips enter his room without a gown.  CMS Ex. 2 at 4-5; CMS Ex. 6 at 2.  Petitioner’s effort to claim the CDC’s guidance in effect at the time of the survey did not indicate the use of a gown unless an isolated resident received “direct care” is without merit. 

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2. Petitioner’s noncompliance concerning the use of PPE did not pose a greater risk to resident health or safety than the potential for causing minimal harm.  

Not all instances of noncompliance amount to substantial noncompliance.  Noncompliance must pose “greater risk to resident health or safety than the potential for causing minimal harm” to justify the imposition of penalties under the Act.  42 C.F.R. § 488.301.  Here, CMS determined Petitioner’s noncompliance with its infection control policy concerning the use of PPE for newly admitted residents in isolation amounted to a “D” level of scope and severity, meaning an isolated instance of noncompliance that presented no actual harm but had the potential for more than minimal harm.  CMS Ex. 1 at 1; State Operations Manual Rev. 185 Ch. 7 § 7400.3.1. 

Relying on its expert witness, Dr. Stillwell, Petitioner argues CNA Phillips’ failure to wear a gown to retrieve a food tray from Resident 1’s room did not pose more than a minimal risk of harm to resident health or safety.  P. Br. at 15; P. Closing Br. at 8-9.  As Dr. Stillwell explained, this incident occurred on day 13 of the 14-day quarantine period provided to Resident 1 in accordance with the CDC’s guidance at the time.  P. Ex. 12 at 5.  Dr. Stillwell pointed out that after the survey at issue here, the CDC revised its guidance to require only a 10-day quarantine period so long as the isolated patient tested negative for COVID-19 around day seven.  Id. at 6.  The doctor observed Resident 1 began his quarantine period on September 3, 2020, remained asymptomatic, and tested negative for COVID-19 on days 6, 13, 28, and 35.  Id. at 5. 

Given these facts, I fully credit Dr. Stillwell’s conclusion that CNA Phillips’ brief interaction with Resident 1 while wearing an N95 mask, face shield, and gloves did not pose the potential for more than minimal harm to resident health and safety because she had not donned a gown.  Petitioner has demonstrated by a preponderance of the evidence that its noncompliance in this instance did not amount to substantial noncompliance.  

3. Petitioner did not implement its infection control policy concerning the handling and transportation of linens.  

42 C.F.R. § 483.80(e) requires skilled nursing facilities to ensure their staff “handle, store, process, and transport linens so as to prevent the spread of infection.”  In its guidance to state surveyors, CMS stated “facility staff should handle all used laundry as potentially contaminated and use standard precautions (i.e., gloves).”  CMS Ex. 10 at 23.8 

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CMS required facilities to bag and contain contaminated laundry at the point of collection, use leak-resistant containers or bags for linens or textiles “contaminated with blood or body substances,” and handle soiled textiles and linens with “minimum agitation” to avoid contaminating the air, surfaces, or people.  Id.  CMS prohibited contaminated linen or laundry bags from being “held close to the body or squeezed when transporting.”  Id. at 24.  The CDC’s guidance mirrored both these admonitions.  P. Ex. 15 at 1. 

CMS argues Petitioner failed to meet its obligation to properly handle laundry, citing Surveyor Walker’s testimony that she observed CNA Sprinkle leave a resident’s room holding linens “in her arms against her chest.”  CMS Ex. 2 at 4-5; CMS Ex. 6 at 2; CMS Ex. 8 at 2.  Petitioner argues the regulations and applicable guidance from CMS and the CDC are not applicable in this instance because they only applied to contaminated or soiled linens, which it asserts meant linens visibly contaminated with blood or other bodily fluids.  P. Br. at 12, 15; P. Closing Br. at 12-14.  Petitioner contends CMS has not established the linens carried by Surveyor Walker were anything more than “used.”  Id.  

I cannot reach the conclusion Petitioner urges – that facilities have no obligation to handle “used” or “dirty” laundry with any particular care unless it is visually “contaminated.”  Petitioner correctly observes the definition of “contaminated laundry” adopted by CMS refers to “laundry which has been soiled with blood/body fluids or other potentially infectious materials or may contain sharps.”  P. Br. at 12, citing P. Ex. 16 at 2; CMS Ex. 10 at 3.  But the definition of “contaminated laundry” is nowhere limited to visually evident soiling.  CMS Ex. 10 at 3.  Such a distinction appears arbitrary as it is based on the notion that only visibly soiled linens posed a risk of cross-contamination – something even Petitioner’s expert did not endorse.9   See Hearing Tr. at 19-20 (testimony of Dr. Stillwell conceding contaminants are not necessarily visible).  

That distinction is equally unrecognized by CMS’s guidance, which advised facilities to treat all used linens as contaminated.  CMS Ex. 10 at 23.  Similarly, the CDC guidelines adopted by Petitioner recommended facility staff “never carry soiled linen against the body” and to avoid transporting soiled linen outside a patient care area without using a bag or bucket.  P. Ex. 15 at 1.10   

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Critically, Petitioner’s staff made clear they understood the facility’s infection control policy to comply with both CMS and CDC guidelines.  CNA Sprinkle conceded she should have carried the “dirty” linens in question in a plastic bag.  CMS Ex. 2 at 5; CMS Ex. 6 at 2.  DON Steel confirmed staff could not carry “dirty” linens against their uniforms because of the risk of cross-contamination.  CMS Ex. 2 at 5; CMS Ex. 6 at 3; CMS Ex. 8 at 2.  It would make little sense for either health care worker to make such admissions unless they understood Petitioner’s policy to require treating all used linens as contaminated.  CMS Ex. 10 at 23. 

Petitioner’s contention that the word “contaminated” refers only to linens containing visually appreciable body fluids is inconsistent with the regulatory admonition that skilled nursing facilities ensure the handling and transportation of linens to prevent the spread of infection.  42 C.F.R. § 483.80(e).  It is unsupported by the definition adopted by CMS for “contaminated” laundry or the CDC’s guidelines for handling and transporting “soiled” laundry.  CMS Ex. 10 at 23; P. Ex. 15 at 1.  It is also inconsistent with the understanding of Petitioner’s policy by its own staff, including its Director of Nursing.  CMS Ex. 2 at 5; CMS Ex. 6 at 2-3; CMS Ex. 8 at 2.  Petitioner cannot plausibly assert its staff had no obligation to use standard laundry handling practices in the handling and transportation of used linens unless they visually confirmed the presence of blood or body fluids.  

4. Petitioner’s noncompliance with its laundry handling policy did not pose a greater risk to resident health or safety than the potential for causing minimal harm

While CMS has established Petitioner’s staff did not implement the facility’s laundry handling policy in at least one instance, Petitioner has established by preponderance of the evidence that CNA Sprinkle’s noncompliance did not pose a greater risk than the potential for causing minimal harm.  I have rejected Petitioner’s argument that it did not need to take the elementary precaution of transporting used linens in a bag or container.  Even if not visibly contaminated, used linens could contain blood or other bodily fluids, as even Dr. Stillwell allowed.  Hearing Tr. at 19-20. 

Nevertheless, Petitioner has set forth specific unrebutted facts that demonstrate CNA Sprinkle’s noncompliance in this instance did not pose a risk of more than minimal harm to resident health and safety.  CNA Sprinkle worked on a non-COVID unit the night before but stayed beyond her scheduled departure to assist the day shift by stripping sheets from resident beds.  P. Ex. 14 at 3.  She did not remake any beds or otherwise

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engage in patient care after she carried the used linens in her arms.  Id.  As Petitioner observes, she simply stripped sheets while residents showered so the day shift staff could remake their beds.  P. Closing Br. at 13, citing P. Ex. 14 at 3.  

Nor is there any evidence residents were at risk of exposure to contamination from CNA Sprinkle’s contact with her colleagues after she carried the used linens.  P. Closing Br. at 13 (“Staff confirmed though surveyor interviews that masks were worn at all times and gowns, gloves, and face shields were available outside the isolation rooms for employee use.”).  CNA Sprinkle only stayed past her shift to strip sheets; CMS has proffered no evidence to indicate she stayed at the facility past this point or interacted with her colleagues in a way that could even suggest the possibility of cross-contamination. In short, CNA Sprinkle improperly handled used linens but did not engage in resident care, touch clean linens, or interact with her co-workers.  There are no facts in evidence that could lead me to conclude a potential for cross-contamination existed that posed a risk of causing even minimal harm to resident health or safety. 

F. The $5,000 per‑instance CMP imposed by CMS is overturned. 

CMS is only authorized to impose enforcement remedies against a facility that is not in substantial compliance with participation requirements.  42 U.S.C. § 1395i-3(h)(2); 42 C.F.R. §§ 488.406, 488.430(a).  CMS has established noncompliance but not that it posed a greater risk than the potential for causing minimal harm to resident health or safety.  See 42 C.F.R. § 488.301; 42 C.F.R. § 488.430(a).  CMS did not have a statutory basis to impose a CMP.  

VII. Conclusion

For the foregoing reasons, I affirm CMS’s determination of Petitioner’s noncompliance but do not find it to be substantial.  The $5,000 per-instance CMP imposed by CMS is overturned.