River Oaks Health and Rehabilitation Center, CR6509 (2024)

DECISION

Petitioner, River Oaks Health and Rehabilitation Center, 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 $15,000 per-instance civil money penalty (CMP). 

As explained herein, I affirm CMS’s finding of deficiency based on Petitioner’s noncompliance with 42 C.F.R. § 483.80(a) (2)(iv) and find the per-instance CMP reasonable. 

I.     Background

Petitioner, River Oaks Health and Rehabilitation Center, is a skilled nursing facility (SNF) located in Fort Worth, Texas that participates in the Medicare program.  CMS Exhibit (Ex.) 1 at 1.  CMS contractor Healthcare Management Systems (HMS) conducted a COVID-19 focused infection control survey at Petitioner’s facility on July 20, 2020 and cited the facility for substantial noncompliance with 42 C.F.R. §§ 483.80(a)(1), (a)(2), (a)(4), (e), and (f) (Tag F880).  CMS Ex. 2 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 3. 

Based on this deficiency finding, CMS notified Petitioner it would impose a $15,000 per-instance CMP.Id.  CMS also advised Petitioner it would withdraw approval of a Nurse Aide Training and Competency Evaluation Program and Competency Evaluation Program, impose a denial of payment for new admissions (DPNA) beginning September 3, 2020, and terminate Petitioner’s Medicare provider agreement if Petitioner did not return to substantial compliance before January 20, 2021.  Id. at 1, 3-4.  On December 14, 2020, CMS notified Petitioner it determined the facility returned to substantial compliance on August 17, 2020.  CMS Ex. 1 at 7.  CMS rescinded the DPNA, termination of Petitioner’s Medicare provider agreement, and confirmed the $15,000 per-instance CMP.  Id. 

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 $15,000 per‑instance CMP, resulting in my designation to hear and decide this case.  I issued an Acknowledgment and 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 12 proposed exhibits (CMS Exs. 1-12) including written direct testimony for two witnesses.  Petitioner filed a pre‑hearing brief (P. Br.), 15 proposed exhibits (P. Exs. 1-15)² including the written direct testimony of

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one witness, and objections to CMS’s exhibits.  Petitioner also requested to cross-examine CMS’s witnesses.  I therefore scheduled a hearing in this matter to take place by videoconference beginning September 22, 2021.  On September 14, 2021, Petitioner filed an unopposed motion for a decision on the record and withdrew its request to cross-examine CMS’s witnesses.  I granted the motion, canceled the hearing, and advised the parties I would decide this matter on the record.  Civ. Remedies Div. P. § 19(d).

II.     Admission of Exhibits

CMS filed 12 proposed exhibits with its pre-hearing brief.  Petitioner objected to CMS Exhibits 1 through 3 and CMS Exhibits 10 through 12.  P. Objections.  Petitioner contends the October 7 and December 14, 2020 Notices of Imposition of Remedies at CMS Exhibit 1 lack proper foundation to establish CMS’s deficiency finding.  Id. at 1.  Petitioner objects to CMS Exhibit 2, the Statement of Deficiencies (SOD), claiming CMS cannot offer what Petitioner characterizes as opinion evidence as to the issue of whether a regulatory violation occurred, or as Petitioner puts it, “a report containing findings of regulatory violations.”  Id.  Petitioner also objects to the surveyor notes at CMS Exhibit 3 as irrelevant with respect to statements made about residents other than Resident 2 and Resident 6, the two residents in isolation the surveyor observed.  Id. at 2. 

Petitioner asserts CMS Exhibit 10 is irrelevant because the CDC updated it on November 20, 2020, making use of these guidelines for a survey that took place in July 2020 more prejudicial than probative.  Id.  Petitioner contends the declaration of CMS witness Susan Finnell found at CMS Exhibit 11 contains inadmissible hearsay and posits improper legal conclusions as to whether a regulatory violation occurred.  Id.  Lastly, Petitioner objects to numerous paragraphs of the declaration of CMS witness Daniel McElroy found at CMS Ex. 12 as irrelevant and otherwise improper legal opinions or, in one instance, based on an improper factual premise.  Id. at 2-3. 

Petitioner’s objection to CMS Exhibit 10 is sustained.  The document indicates the CDC updated this guidance on November 20, 2020, but gives no way to determine what aspects of the guidance were in effect prior to the survey at issue here.  Without such clarification, CMS cannot rely on this guidance to establish a deficiency finding for a survey that took place in July 2020, three months before Petitioner could have been aware of at least parts of it.³ 

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The remainder of Petitioner’s objections are overruled.  To the extent CMS’s exhibits contain improper legal conclusions reserved to me, I disregard them.  However, observations and findings made by the surveyor remain relevant.  Petitioner’s other objections do not require exclusion of CMS’s exhibits but instead pertain to the weight I should accord them.  I admit CMS Exhibits 1 through 12 and Petitioner’s Exhibits 1 through 15 into the record. 

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 $15,000 per-instance CMP was reasonable. 

IV.     Jurisdiction

I have jurisdiction to hear and decide this case.  42 U.S.C. § 1395i-3(h)(2)(B)(ii); 42 C.F.R. §§ 488.408(g), 488.434(a)(2)(viii), 498.3(b)(13). 

IV     Statutory and Regulatory Authority for the Imposition of Penalties

The Social Security Act (Act) sets forth requirements for a SNF’s participation in the Medicare program and authorizes the Secretary of Health and Human Services (the Secretary) to promulgate regulations implementing those statutory provisions.  42 U.S.C. § 1395i-3.  These implementing regulations are found at 42 C.F.R. Parts 483 and 488.  
To participate in the Medicare program, a SNF like Petitioner must maintain substantial compliance with program participation requirements.  To be in substantial compliance, a 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.  A deficiency is a violation of a participation requirement established by 42 U.S.C. § 1395i-3(b)-(d), or the Secretary’s regulations at 42 C.F.R. pt. 483, subpt. B.  Id.  “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 the participation requirements.  42 U.S.C. § 1395aa(a); 42 C.F.R. § 488.10.  The Act also authorizes the Secretary to impose enforcement remedies against SNFs that are not in substantial compliance with program participation requirements.  42 U.S.C. § 1395i-3(h)(2).  The Secretary’s regulations specify the enforcement remedies that CMS may impose if a facility is not in substantial compliance.  42 C.F.R. § 488.406. 

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CMS has the authority to impose a per-instance civil money penalty (CMP) from $1,000 to $10,000, adjusted annually for inflation. 42 C.F.R. § 488.408 (d)(1)(iv); 45 C.F.R. Part 102.  In 2020, a per-instance CMP could range from $2,233 to $22,320.  86 Fed. Reg. 62,938. 

If CMS imposes a CMP based on a determination of noncompliance, the facility may request a hearing before an ALJ to determine whether there was a basis for the deficiency findings that led to the imposition of the remedy and whether the CMP imposed was reasonable.  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).  However, the facility may not appeal CMS’s choice of remedies.  42 C.F.R. § 488.408(g)(2). 

VI.     Burdens of proof and persuasion

Neither the Act nor its implementing regulations allocate the burden of proof or the quantum of evidence necessary to meet that burden.  In the context of a regulatory enforcement action, it would be reasonable to require the enforcing agency to establish by proof and persuasion that it was justified to impose penalties under the Act and its regulations.  Nevertheless, the Departmental Appeals Board has 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 Srvs., 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); 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 showing⁴ it had a basis for termination.  In Hillman, 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’] 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’] evaluation

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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, Petitioner bears the burden of persuasion and must prove by a preponderance of the evidence of record that it substantially complied with statutory and regulatory requirements.  See 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). 

To date, federal district and circuit courts have declined to disturb this burden-shifting regime on due process or other grounds.⁵  See, e.g., Hillman Rehab. Ctr., DAB No. 1611 (1997), aff’d, Hillman Rehab. Ctr. v. U.S. Dep’t of Health & Human Srvs., 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 Srvcs., 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). 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:

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(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:

(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). 

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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. 2768 at 7-8 (2017).  Upon establishing such policies and protocols, a facility is then required to 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 advised nursing homes to rely on information and resources provided by the Centers for Disease Control (CDC).⁶  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-covi… (last rev. Mar. 13, 2020). 

On May 19, 2020, the CDC issued guidelines to help nursing homes prepare for the COVID-19 pandemic. ⁷  That guidance identified “Core Practices” facilities needed to establish, among them the need to develop a plan for the admission and readmission of residents of unknown COVID-19 status.  May 2020 CDC Guidance at 2, 6.  The CDC advised nursing homes to consider: 

Depending on the prevalence of COVID-19 in the community, this might include placing the resident in a single-person room or in a separate observation area so the resident can be monitored for evidence of COVID-19.   [Healthcare personnel]⁸ should wear an N95 or higher-level respirator (or facemask if a

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respirator was not available), eye protection (i.e., goggles or a face shield that covers the front and sides of the face), gloves, and gown when caring for these residents.  Residents can be transferred out of the observation area to the main facility if they remain afebrile and without symptoms for 14 days after their admission.  Testing at the end of this period can be considered to increase certainty that the resident is not infected. 

Id. at 6-7.  

In June 2020, the CDC issued guidelines pertaining to the use of Personal Protective Equipment (PPE) by facility staff when caring for infected or potentially infected residents.  CMS Ex. 9 at 1.  The CDC specified the proper sequence of events to don and doff PPE gear by facility staff and advised placement of facemasks on infected or potentially infected residents during medical evaluations.  Id. at 1-2. 

C. River Oak’s infection control policy

Petitioner’s infection control policy included “Standard Precautions” applicable to the care of all residents where staff would be exposed to blood, body fluids, secretions, and excretions.  CMS Ex. 8 at 1. This policy required staff to wear a mask and eye protection or a face shield during procedures and resident care activities “likely to generate splashes or sprays of blood, body fluids, secretions and excretions.”  Id.  It also required wearing gloves under the same conditions with prompt removal after use.  Id. 

Petitioner’s policy set forth heightened precautions for individuals documented with or suspected to have infectious or communicable diseases, referred to as “Transmission-Based Precautions.”  CMS Ex. 7 at 1.  The policy acknowledged CDC guidance identified the overall approach to prevention of communicable diseases as “Isolation Precautions,” and indicated it would use the same term, which encompassed the facility’s Standard and Transmission-Based Precautions.  Id.  

Consistent with the CDC’s definitions, Petitioner’s infection control policy identified additional precautionary measures to take depending on whether the risk of transmission was airborne, by contact, or by droplet.  Id.  The policy required the facility to employ color-coded signs or stickers on residents’ doors, beds, and charts to alert its staff of the appropriate precautions to use for a resident (blue for airborne precautions, orange for contact precautions, and yellow for droplet precautions).  CMS Ex. 7 at 2-3, 5.  Airborne precautions required staff to wear respiratory protection when entering the room of an isolated resident.  Id. at 2.  Contact precautions required staff to don gloves and a gown to

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enter the room and to remove both before leaving the resident’s room, as well as washing hands.  Id. at 3.  Droplet precautions required staff to use a mask when working within three feet of a resident.  Id. at 4. 

Petitioner set forth additional procedures to address the COVID-19 pandemic in its March 9, 2020 COVID-19 Infection Control policy.  CMS Ex. 6 at 1.  Under that policy, Petitioner implemented symptom screening for all residents every shift.  Id. at 3.  Petitioner also began screening all visitors and residents entering the facility; its policy barred any non-resident with a temperature of 100.4 degrees F or higher from entering.  Id. at 2.  Residents re-entering with a temperature of 100.4 degrees F or higher would be placed in necessary PPE equipment and isolated until their symptoms subsided unless those symptoms had a known cause other than COVID-19.  Id.  Any resident returning from hospitalization who did not require isolation could nevertheless be placed in a private room for 14 days to ensure they remained symptom-free, if the facility could accommodate them.  Id. 

Petitioner updated its infection control policy on April 20, 2020 to set forth procedures to monitor residents’ symptoms, the storage and use of facemasks, notification requirements for positive cases, and cohorting of staff and residents as needed for containment.  Id. at 3-5.  Petitioner’s policy required staff to always wear face masks in the facility and use “appropriate PPE” to interact with residents to the extent such PPE was available.  Id. at 3.  For residents with a known or suspected COVID-19 diagnosis or symptoms thereof, the policy required staff to use “[f]ull PPE . . . per CDC guidelines” to care for those residents.  Id. at 4.  In the event of COVID-19 transmission within the facility, the policy required staff to don full PPE to care for all residents, regardless of infection status.  Id.  

D. Relevant Facts

Petitioner admitted Resident 6 on June 23, 2020; her diagnoses included displaced left femur fracture, hypothyroidism, Alzheimer’s disease, hypertension, muscle wasting and atrophy, muscle weakness, abnormalities of gait and mobility, lack of coordination, and symbolic dysfunctions.  CMS Ex. 5 at 12, 14.  On July 1, 2020, facility staff discovered Resident 6 on the floor in her room after a fall with complaints of pain in the back of her head and left hip.  Id. at 10.  They called 911 and transferred Resident 6 to the hospital.  Id. 

Resident 6 returned to Petitioner’s facility from the hospital on July 8, 2020.  CMS Ex. 2 at 4; CMS Ex. 5 at 1.  Resident 6’s physician ordered her strict isolation as of July 1, 2020 in a single-occupancy room to prevent COVID-19 exposure.  CMS Ex. 5 at 5.  That order required the facility to provide all therapy, treatments, and meals to Resident 6 in her room.  CMS Ex. 5 at 5, 18-19, CMS Ex. 2 at 4; P. Ex. 8 at 4, 28. 

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Petitioner admitted Resident 2 on July 17, 2020 with diagnoses of congestive heart failure, diabetes mellitus, morbid obesity, hypertension and altered mental status.  CMS Ex. 2 at 4; CMS Ex. 4 at 1.  Resident 2’s physician ordered his strict isolation in a single-occupancy room to prevent COVID-19 exposure.  CMS Ex. 4 at 5.  That order required the facility to provide all therapy, treatments, and meals to Resident 2 in his room.  CMS Ex. 2 at 4, CMS Ex. 4 at 5, 13; P. Ex. 6.  

On July 20, 2020, Surveyor Susan Finnell conducted a survey of Petitioner’s facility on behalf of CMS focused on COVID-19 infection control.  CMS Ex. 11 at 2.  She noted resident rooms in one hallway were designated for 14-day isolation of newly admitted or readmitted residents.  CMS Ex. 2 at 3; CMS Ex. 11 at 3.  In that hallway, the surveyor observed PPE drawers outside of each room and signs on the doors directing staff to see the nurse prior to entering the rooms.  Id.  She also noticed the doors to Resident 2’s and Resident 6’s room were open, even though both had signs on their doors and PPE drawers stationed outside them.  Id.  Later that day, Surveyor Finnell observed CNA 2 ⁹ don a mask, gown, and gloves prior to entering Resident 6’s room, but not eye protection.  CMS Ex. 2 at 6; CMS Ex. 3 at 2; CMS Ex. 11 at 5. 

Surveyor Finnell interviewed members of staff as well.  Director of Nursing (DON) Betty Williams acknowledged the signs on residents’ doors instructed visitors to first see the nurse and did not indicate the type of isolation or PPE needed for any given resident.  CMS Ex. 2 at 4; CMS Ex. 11 at 3.  Licensed Vocational Nurse (LVN) Nancy Jackson stated Resident 2 was on contact isolation while Resident 6 was subject to isolation for C. difficile.  CMS Ex. 2 at 4-5; CMS Ex. 3 at 1; CMS Ex. 11 at 4.  LVN Leigh Ann Haworth agreed Resident 6 was isolated for C. difficile but told the surveyor Resident 2 was on contact isolation because he had been newly admitted from the hospital. CMS Ex. 2 at 5; CMS Ex. 3 at 1; CMS Ex. 11 at 4.

Facility Administrator Dominicia Morgan stated newly admitted residents were subject to contact isolation.  Id.  Social Worker Tiffany Doss confirmed Residents 2 and 6 were under physician’s orders for strict isolation for 14 days from admission and defined strict isolation to mean confining the resident to their room with the door closed and providing meals in-room on disposable dishes while staff donned full PPE (including a mask, gown, gloves, and eye protection) to enter.  CMS Ex. 2 at 5, CMS Ex. 3 at 2; CMS Ex. 11 at 4-

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5.  Regional Director of Clinical Services Kennethia Brooks confirmed strict isolation required used of full PPE to enter a resident’s room and that the facility followed the CDC’s recommended guidelines pertaining to newly admitted residents.  CMS Ex. 2 at 5-6; CMS Ex. 3 at 2; CMS Ex. 11 at 5.  

Both DON Williams and the Assistant Director of Nursing (ADON)¹⁰ stated the facility’s infection control policy required newly admitted or readmitted residents with an unknown COVID-19 status to be placed in a private room and subjected to strict isolation for 14 days.  CMS Ex. 2 at 6; CMS Ex. 3 at 2; CMS Ex. 11 at 5.  DON Williams confirmed strict isolation required staff to don a mask, gown, gloves, and eye protection.  Id.  Both DON Williams and the ADON asserted newly admitted or readmitted residents who tested positive for COVID-19 were placed in the facility’s COVID-19 unit.  Id.  Both also confirmed this admission policy was verbal and not in writing.  Id. 

Medical Director Rachel Villegan agreed that strict isolation of residents required facility staff to wear full PPE (meaning a mask, gown, gloves, and eye protection), closing the doors of residents’ rooms, and maintaining strict isolation for 14 days.  Id. 

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

There are essentially two bases for a finding of noncompliance concerning the adequacy of a facility’s infection control program:  either it fails to establish a written policy that is adequate to meet the facility’s obligation to provide infection control consistent with the regulatory requirements and applicable national standards, or the facility fails to implement its policy in a manner to ensure it is effective.  42 C.F.R. § 483.80(a); Golden Living Ctr. – Superior, DAB No. 2768 at 7-8; Heritage House of Marshall Health & Rehab. Ctr., DAB No. 2566 at 12-13.  For the reasons set forth here, I conclude Petitioner failed in both respects. 

1. Petitioner’s written infection control policy did not set forth procedures for when and how to isolate asymptomatic residents during the COVID-19 pandemic.

42 C.F.R. § 483.80(a)(2) requires SNFs to establish “[w]ritten standards, policies, and procedures” that identify the type of precautions necessary to prevent the spread of infection, when and how residents should be isolated, and the type and duration of isolation necessary based on the infectious agent or organism involved.  42 C.F.R. § 483.80(a)(2)(iii),(iv). 

CMS claims Petitioner failed to establish a written policy pertaining to the use of strict isolation for new or readmitted residents who did not exhibit symptoms suggestive of

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COVID-19, an omission that resulted in the failure of its staff to implement the necessary requirements to maintain strict isolation, including conspicuous identification of a resident’s isolation status, closing doors to the residents’ rooms, and use of eye protection per CDC guidelines.  CMS Br. at 7-8.  Petitioner argues its infection control policy was not deficient because it had no obligation under the regulations or applicable CDC guidance to impose strict isolation on residents who were not known to have or suspected of having COVID-19.  P. Br. at 3.  Petitioner emphasizes Resident 2 and Resident 6 did not have and were not suspected of having COVID-19 and were placed in 14-day isolation as a purely preventative measure.  Id. 

Petitioner’s argument is erroneous.  While the CDC guidance in effect at the time of the survey did not require isolation of new and readmitted asymptomatic residents, it did require nursing homes to “[c]reate a [p]lan” to manage new and readmitted residents of unknown COVID-19 status.  May 2020 CDC Guidance at 6.¹¹ 

But Petitioner did not do so, at least in writing.¹² The policy it issued in March 2020 at the onset of the COVID-19 pandemic only stated “[i]f the facility can accommodate, ANY resident returning from the hospital can be placed in a [private] room for the next 14 days to ensure no symptoms become present related to the recent hospitalization.”  CMS Ex. 6 at 2.  This policy was inadequate on its face because it does not specify when a readmitted asymptomatic resident would be placed in isolation.  See 42 C.F.R. § 483.80(a)(2)(iv).  It only acknowledges Petitioner could do so “[i]f the facility can accommodate.”  CMS Ex. 6 at 2.  Stating the facility could isolate residents returning from hospitalization if it could “accommodate” provides no objective criteria for facility staff to apply to determine when or how to isolate new or readmitted asymptomatic residents.  That is not a plan; it is an option.  

Petitioner’s policy is otherwise inadequate because it altogether fails to address the intake of new residents, as the CDC’s guidance required.  CMS Ex. 6 at 2; May 2020 CDC Guidance at 6.  Petitioner cannot credibly claim it fashioned a policy that conformed to the CDC’s admonition to create a plan to manage intake of new residents during the COVID-19 pandemic. 

Finally, Petitioner’s written policy is inadequate because it failed to specify the type of isolation necessary for readmitted asymptomatic residents beyond simply stating they “could” be placed in a private room for 14 days if the facility could “accommodate.” 

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CMS Ex. 6 at 2.  At minimum, the facility’s plan had to indicate the type of isolation appropriate for an asymptomatic resident being monitored for potential COVID-19 infection.  42 C.F.R. § 483.80(a)(2)(iv)(A); May 2020 CDC Guidance at 6.  It did not do so.  For these reasons, I find Petitioner did not substantially comply with its obligation to establish a written infection control policy that followed “accepted national standards” set forth by the CDC at the time of the survey.  42 C.F.R. § 483.80(a)(1), (2). 

2. Petitioner did not comply with its written or unwritten infection control policy.

CMS contends Petitioner failed to adequately implement its protocols for the strict isolation of asymptomatic readmitted residents.  CMS Br. at 7-8.  Specifically, CMS alleges the facility failed to ensure its staff knew “full PPE” required the use of eye protection under CDC guidelines and the facility’s own verbal policy.  Id. at 7.  CMS also claims Petitioner failed to ensure its staff knew the level of isolation appropriate for each isolated resident, demonstrated by the fact that facility staff erroneously believed Resident 6 to be under contact isolation for a C. difficile infection.  Id. at 7-8.  CMS finally asserts facility staff failed to comply with the requirements for isolation of Residents 2 and 6 based on facility policy, CDC guidelines, and orders from the residents’ physicians by leaving the doors open in rooms where Residents 2 and 6 were supposed to be in isolation and failing to don the appropriate PPE for strict isolation, specifically eye protection, prior to entering the isolated residents’ rooms.  CMS Br. at 8; CMS Ex. 2 at 3-6. 

Petitioner responds that it adequately implemented its infection control policy, as evidenced by regular in-service staff training sessions, and that its staff in fact complied with its policy, which did not require use of eye protection unless a resident was known or suspected to have a COVID-19 infection.  P. Br. at 3, citing P. Ex. 3, P. Ex. 4.  Petitioner asserts it had no obligation under CDC guidelines, its own policy, or the residents’ physician’s orders to impose strict isolation or keep the residents’ doors closed, particularly given Resident 2’s high fall risk.  Id. at 5.  Petitioner claims there is no evidence Resident 6 was even under a physician’s order for isolation.  Id. at 7.  

Petitioner’s argument that it had no obligation to isolate Residents 2 and 6 is without merit.  The record before me makes plain that Petitioner established an unwritten policy to strictly isolate new or readmitted asymptomatic residents for 14 days.¹³ Both DON Williams and the ADON understood the facility’s infection control policy to require newly admitted or readmitted residents of unknown COVID-19 status to be placed in a

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private room on strict isolation for 14 days.  CMS Ex. 2 at 6; CMS Ex. 3 at 2; CMS Ex. 11 at 5.  Medical Director Villegan confirmed strict isolation required the facility to keep the doors of isolated residents’ rooms closed for 14 days.  CMS Ex. 2 at 6; CMS Ex. 3 at 2; CMS Ex. 11 at 5.  Administrator Morgan declared facility policy required “all new admissions and/or hospital readmissions [to be] quarantined on a separate unit or cohort for an initial period of 14 days. . . .”  P. Ex. 14 at 2. 

Petitioner’s claim that it was under no obligation to ensure its staff wore eye protection or keep the doors of Resident 2’s and 6’s rooms closed is also without merit.  There is no dispute that the facility’s policy of “strict isolation” of new or readmitted asymptomatic residents required staff to use eye protection.  DON Williams confirmed strict isolation required staff to don a mask, gown, gloves, and eye protection.¹⁴  CMS Ex. 2 at 6; CMS Ex. 3 at 2; CMS Ex. 11 at 5.  Medical Director Villegan agreed strict isolation required facility staff to wear full PPE (meaning a mask, gown, gloves, and eye protection).  Id.  Social Worker Doss defined strict isolation as confining the resident to their room with the door closed and providing meals in-room on disposable dishes while staff donned full PPE (including a mask, gown, gloves, and eye protection) to enter.  CMS Ex. 2 at 5, CMS Ex. 3 at 2; CMS Ex. 11 at 4-5.  Regional Director of Clinical Services Brooks agreed strict isolation required use of full PPE to enter a resident’s room and that the facility followed the CDC’s recommended guidelines pertaining to newly admitted residents.  CMS Ex. 2 at 5-6; CMS Ex. 3 at 2; CMS Ex. 11 at 5.  

In short, Petitioner’s claim that it did not have to follow CDC guidelines concerning the strict isolation of new or readmitted asymptomatic residents is obviated by the fact that it chose to follow those guidelines.  Once it established a policy to isolate new or readmitted asymptomatic residents for 14 days to prevent the spread of COVID-19, Petitioner was obligated to implement that policy and ensure its effectiveness.  Golden Living Ctr. – Superior, DAB No. 2768 at 7-8.  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.  Petitioner cannot claim it had

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no obligation to implement its own policy to provide 14 days of strict isolation for new or readmitted asymptomatic residents like Residents 2 and 6. 

Having established Petitioner’s self-imposed obligation to strictly isolate asymptomatic returning residents, the record confirms Petitioner’s staff did not follow its own policies, including some set forth in writing and in effect well before the COVID-19 pandemic.  Petitioner’s pre-existing written infection control policy required its staff to employ color-coded signs or stickers on residents’ doors, beds, and charts to alert its staff of the appropriate precautions to use for a resident in isolation (blue for airborne precautions, orange for contact precautions, and yellow for droplet precautions).  CMS Ex. 7 at 2-3, 5.  But Surveyor Finnell noted the doors to Resident 2 and 6’s rooms displayed only signs with direction to “see the nurse before entry . . . .”  CMS Ex. 11 at 3.  Petitioner failed to comply with its own written policy to employ a color-coded sign system to alert its staff as to the precautions necessary to enter Resident 2 and 6’s rooms. 

As such, it is perhaps unsurprising that facility staff did not understand the level of precaution necessary to care for Resident 2 or 6.  Surveyor Finnell observed CNA 2 enter Resident 6’s room without eye protection.¹⁵  CMS Ex. 2 at 6; CMS Ex. 3 at 2; CMS Ex. 11 at 5.  LVN Jackson told the surveyor that Resident 2 was on contact isolation ¹⁶ while Resident 6 was subject to isolation for C. difficile.  CMS Ex. 2 at 4-5; CMS Ex. 3 at 1; CMS Ex. 11 at 4.  LVN Haworth agreed Resident 6 was isolated for C. difficile but thought Resident 2 was on contact isolation because he had been newly admitted from the hospital.  CMS Ex. 2 at 5; CMS Ex. 3 at 1; CMS Ex. 11 at 4.  In fact, Petitioner’s unwritten policy required the use of full PPE to care for Residents 2 and 6 because they were under strict isolation.  CMS Ex. 2 at 5-6; CMS Ex. 3 at 2; CMS Ex. 11 at 4-5. 

Petitioner’s claim it was not required to keep Resident 2 and 6’s room doors shut is without merit.  There is no dispute that the facility’s strict isolation policy applied to both residents, that it required the doors to the residents’ rooms be kept shut, and that Surveyor

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Finnell observed both residents’ doors left open during the survey.  CMS Ex. 2 at 3, 5-6; CMS Ex. 3 at 1, 2; CMS Ex. 11 at 3, 4-5.  Petitioner makes no effort at all to justify keeping Resident 6’s door open.  It otherwise argues Resident 2’s documented risk of falls required the facility to leave his door open to allow staff to monitor him. ¹⁷  P. Br. at 5, citing P. Ex. 7.  Petitioner asserts the regulations afford facilities the flexibility to balance these competing concerns.  Id. 

Petitioner’s claim is not persuasive.  The fact that it makes no effort to explain why it left Resident 6’s door open suggests its staff either did not know to keep the doors of isolated residents’ rooms closed or simply did not bother to do so.  Even if I accept the premise that Petitioner could justify keeping at least one resident’s door open, it has not done so.  Petitioner’s unwritten infection control policy clearly required Resident 2’s door to be closed.  CMS Ex. 2 at 5-6; CMS Ex. 3 at 2; CMS Ex. 11 at 4-5.  Even if Resident 2’s care plan required intervention to ameliorate his risk of fall, the facility should have considered less extreme measures than negating the emergency infection control policy it effected during a global pandemic.  Petitioner could have consulted Resident 2’s physician and obtained that doctor’s perspective on appropriate alternative interventions.  It could have consulted local or state health authorities.  It could have instructed its staff to enter Resident 2’s room at set intervals to ensure his safety.  It did none of these things.  Had Petitioner made any effort at all to balance keeping a resident safe from falls with its obligation to keep all its residents safe from a deadly virus, its argument would have more merit. 

Accordingly, I find Petitioner failed to follow its own written and unwritten infection control policies and thus failed to substantially comply with its obligation to maintain an effective infection control program pursuant to 42 C.F.R. § 483.80(a)(1).  Golden Living Ctr. – Superior, DAB No. 2768 at 7-8; Heritage House of Marshall Health & Rehab. Ctr., DAB No. 2566 at 12-13.  Petitioner’s noncompliance exposed its residents to the risk of infection and therefore had the potential for more than minimal harm to resident health and safety. 

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F. The $15,000 per‑instance CMP imposed by CMS is reasonable.

CMS is 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.  Here, CMS imposed a per-instance CMP in the amount of $15,000.  CMS Ex. 1. 

In determining the reasonableness of the penalty amount imposed, I look to the factors set forth at 42 C.F.R. §§ 488.438(f) and 488.404 (incorporated by reference into 42 C.F.R. § 488.438(f)(3)).  See also 42 U.S.C. §§ 1320a-7a(d)(2), 1395i-3(h)(2)(B)(ii)(I).  These factors include the seriousness of the deficiency, the facility’s compliance history, its financial condition, and its degree of culpability.  Id.  The Board has held the CMP amount selected by CMS is presumptively reasonable based on the regulatory factors listed above and places the burden on facilities “to demonstrate, through argument and the submission of evidence addressing the regulatory factors, that a reduction [in the penalty amount] is necessary to make the CMP amount reasonable.”  Crawford Healthcare & Rehab., DAB No. 2738 at 19 (2016). 

Petitioner argues that it did not commit any deficient practice, observes neither Resident 2 nor Resident 6 had COVID-19, and points to the fact that no infection spread among the residents.  P. Br. at 9.  Petitioner also asserts it complied with physician’s orders for Resident 2 and Resident 6.  Id. 

With respect to the factors set forth at 42 C.F.R. § 488.438(f), CMS argues Petitioner’s history of noncompliance supports the CMP.  CMS Br. at 9.  CMS proffered testimony from Daniel J. McElroy, R.N., a nurse consultant in its employ.  CMS Ex. 12.  Nurse McElroy pointed out Petitioner had been cited twice under Tag F880 tags in the last two years.  Id. at 3.  This limited history of noncompliance is consistent with the mid-range penalty amount CMS selected. 

CMS also argues the seriousness of Petitioner’s noncompliance had the potential for more than minimal harm (and could lead to serious harm) due to the potential spread of infectious disease.  CMS Br. at 9, citing CMS Ex. 12 at 6.  CMS argues the factor of culpability supports the selected CMP because “the evidence supports multiple components of noncompliance with the regulatory requirement.”  CMS Br. at 9, citing CMS Ex. 12 at 3, 7. 

Petitioner contends the CMP is not supported by the seriousness of the deficiency, which it characterizes as an isolated incident at the “D” level of scope and severity, the lowest possible level other than substantial compliance.  P. Br. at 9.  Petitioner claims the proposed CMP is within a few thousand dollars of the maximum amount allowed by law.  Id.  Petitioner suggests the CMP selected by CMS is “something one would expect to see for an immediate jeopardy type citation.”  Id. 

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Petitioner’s claim that an isolated “D” level deficiency may not support a higher penalty is well taken, but its characterization of the $15,000 penalty amount as approaching the maximum amount of $22,320 is misleading.  Moreover, I must also consider Petitioner’s high level of culpability in failing to establish written infection control protocols for new and readmitted asymptomatic residents of unknown COVID-19 status.  Petitioner knew it was required to establish policies according to accepted national standards that would protect the residents from a deadly novel virus to which the elderly were susceptible. 

But Petitioner failed to update its written policy even after the CDC issued guidance in May 2020 identifying this particular issue as a core practice area.  There is no dispute its senior staff and management understood the need to implement a policy, and in fact did so. Yet the policy remained unwritten.  CMS Ex. 2 at 5-6; CMS Ex. 3 at 2; CMS Ex. 11 at 4-5.  For that reason, Petitioner’s staff were unclear as to the exact requirements to provide strict isolation to Residents 2 and 6 and in several instances failed to comply with the facility’s own policy.  Petitioner’s noncompliance had the potential for more than minimal harm.  Given the unique vulnerability of nursing home populations to respiratory pathogens like COVID-19, Petitioner’s culpability is high.  

Finally, Petitioner does not claim its financial condition affects its ability to pay the CMP.  Based on my analysis of the regulatory factors, I find the imposition of a $15,000 per-instance CMP to be reasonable.  

VII.     Conclusion

For the foregoing reasons, I conclude Petitioner was not in substantial compliance with 42 C.F.R. § 483.80(a) and that the $15,000 per-instance CMP imposed by CMS is reasonable.   
 

Endnotes

¹  Scope and severity levels, designated by letters “A” through “L,” derive from the scope and severity matrix published by CMS in its State Operations Manual (SOM), the agency’s published guidance for surveyors of long-term care facilities.  Ctrs. for Medicare and & Medicaid Servs., Pub. 100-07, State Operations Manual Rev. 185 Ch. 7 § 7400.3.1 (eff. Nov. 16, 2018)), available at https://www.cms.gov/regulations-and-guidance/guidance/manuals/downloads…; Facilities with deficiencies of levels A, B, or C remain in substantial compliance.  Id.  Levels D, E, or F indicate a deficiency that presents no actual harm but has the potential for more than minimal harm that does not amount to immediate jeopardy.  Id.  Levels G, H, or I indicate a deficiency that involves actual harm that does not amount to immediate jeopardy.  Id.  Scope and severity levels J, K, and L contain deficiencies that constitute immediate jeopardy to resident health or safety.  Id.  The matrix specifies which remedies are required and optional at each level based upon the pervasiveness of the deficiency (isolated, pattern, or widespread).  Id. 

²  Petitioner’s exhibit list identified 16 proposed exhibits, including the written declaration of proposed witness Betty Williams, the facility’s Director of Nursing (P. Ex. 16).  However, Petitioner did not actually submit P. Ex. 16, though it referenced that exhibit in its pre-hearing brief.  P. Br. at 4, 6.  I granted Petitioner leave to submit this missing exhibit.  DAB E-File Dkt. 20-787, Doc. No. 22.  Petitioner subsequently amended its exhibit list to indicate it no longer wished to offer P. Ex. 16 into evidence.  DAB E-File Dkt. C-20-787, Doc. No. 23.  I have not considered that exhibit nor arguments made by Petitioner related to it.

³  CMS’s lack of effort here is striking.  As I discuss infra at p. 8, the CDC guidance in effect at the time of the survey is readily available on that agency’s website.  CMS should have taken better care to cite and submit the appropriate guidance as part of its case-in-chief.  At the least, Petitioner’s objections should have signaled CMS to address this defect by either responding to those objections or by seeking leave to supplement the record.  It is not my role to fill evidentiary gaps for either party. 

⁴  The Board has not specified the quantum of evidence necessary for CMS to show it met its prima facie burden but has observed CMS must produce “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 with a regulatory requirement.”  Evergreene Nursing Care Ctr., DAB No. 2069 at 7 (2007); see also Black’s Law Dict. (8th ed. 2004) at 1228 (“Prima facie” means generally that the evidence is ‘[s]ufficient to establish a fact or raise a presumption unless disproved or rebutted’”).  

⁵  The U.S. Supreme Court 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 Administrative Procedure Act to impose any requirements upon regulated entities which constituted a change in a substantive legal standard.  Azar v. Allina Health Srvcs., 587 U.S. 566, 139 S. Ct. 1804 at 1809-14 (2019).  It remains to be seen whether federal courts applying the Allina standard in reviewing the Board’s burden-shifting regime will find it constitutes a “change in a substantive legal standard” under the Allina holding. 

⁶  The CDC serves as the nation’s public health agency.  It “conducts critical science and provides health information” to protect the nation from health threats as they arise.  Ctrs. for Disease Control and Prevention, About CDC, available at https://www.cdc.gov/about/cdc/index.html (last rev. Feb. 12, 2024). 

⁷  CMS submitted a version of this guidance as CMS Exhibit 10.  I rejected this exhibit because it sets forth guidance updated by the CDC in November 2020, three months after the survey at issue here.  However, the guidance in effect at the time of the survey is publicly available.  See Ctrs. for Disease Control and Prevention, Preparing for COVID-19 in nursing homes, available at https://stacks.cdc.gov/view/cdc/88410 (last rev. May 19, 2020) (hereinafter May 2020 CDC Guidance).  I take judicial notice of this document as the fact it embodies CDC guidance is not subject to reasonable dispute and because it is readily accessible from the CDC’s own website, making its authenticity not reasonably questionable. 

⁸  Healthcare Personnel include emergency medical service personnel, nurses, nursing assistants, physicians, technicians, phlebotomist, pharmacists, students and trainees, contractual staff not employed by the healthcare facility, and individuals not directly involved in patient care who could be exposed to infectious agents transmitted in the healthcare setting (e.g., clerical, dietary, environmental services, laundry, security, engineering and facilities management, administrative, billing, and volunteer personnel).  May 2020 CDC Guidance at 9.  

⁹  CMS typically offers into evidence a key correlating the names of facility employees and the monikers used to anonymize them in the survey report.  In keeping with its lackadaisical presentation of its case, it did not do so here.  This instance exemplifies the importance of doing so.  Surveyor Finnell appears to identify CNA 2 as Charlie Davis in her survey notes.  Compare CMS Ex. 2 at 6 (stating the surveyor observed “CNA2 donning PPE prior to entering [the room of Resident 6]” at 4:50 p.m. without donning eye protection), with CMS Ex. 3 at 2 (4:50 entry indicating “Charlie Davis CNA, isolation rooms, wear mask, gown, gloves and take off gown and gloves in room before leaving.”).  But Administrator Morgan declared the nurse aide, who she identifies as Lisa Bise, told the administrator she wore a face shield when entering the rooms of Residents 2 and 6.  P. Ex. 14 at 4.  I need not resolve the issue of this individual’s identity, but because I cannot do so, I refer to her as CNA 2 in this decision. 

¹⁰  Identified only as “Charles ADON” in the surveyor’s notes.  CMS Ex. 3 at 2.

¹¹  Signaling the significance of this requirement, the CDC identified the issue of developing a plan to manage admission and readmission of residents of unknown COVID-19 status as one of several “core [infection prevention and control] practices that should remain in place even as nursing homes resume normal practices…”  May 2020 Guidance at 2. 

¹²  As I discuss below, Petitioner developed a plan to manage returning asymptomatic residents by placing them in strict isolation for 14 days but did not publish or effectively implement it. 

¹³  Accordingly, I need not resolve the parties’ dispute as to the level of isolation ordered by the residents’ physicians or whether Resident 6’s isolation order had expired.  The facility’s own policy demanded “strict isolation” for both residents because they were readmitted from hospitalization.  The exact level of isolation contemplated by their physicians is therefore irrelevant, as is the lower contact precaution standard that would apply to a resident diagnosed with C. difficile. 

¹⁴  Petitioner incorrectly claims its staff did not have to wear eye protection while entering Resident 2 or 6’s rooms because CDC guidelines concerning the use of PPE were merely advisory and that no consensus as to the necessary level of PPE existed at this point of the COVID-19 pandemic.  P. Br. at 3.  In fact, CMS directed SNFs like Petitioner to rely on guidance from the CDC to meet their regulatory infection control obligations during the COVID-19 pandemic.  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-covi… (last rev. Mar. 13, 2020).  The CDC’s guidance in effect at the time of the survey clearly advised SNFs their staff should “wear an N95 or higher-level respirator (or facemask if a respirator was not available), eye protection (i.e., goggles or a face shield that covers the front and sides of the face), gloves, and gown when caring for these residents.”  May 2020 CDC Guidance at 6-7 (emphasis added). 

¹⁵  Petitioner contests the surveyor’s observation, relying on Administrator Morgan’s declaration that she spoke with CNA 2, who claimed she wore a face shield when entering Resident 2 and 6’s rooms.  P. Ex. 14 at 4.  I do not credit this hearsay statement embedded in the facility administrator’s declaration.  Surveyor Finnell declared under penalty of perjury that she witnessed CNA 2 enter Resident 6’s room without donning eye protection.  CMS Ex. 11 at 5.  This observation is consistent with the contemporaneous documentation from her survey notes and the statement of deficiencies.  CMS Ex. 2 at 6; CMS Ex. 3 at 2.  Meanwhile, the statement Administrator Morgan attributes to CNA 2 is contained in a declaration she signed in anticipation of litigation months after the survey took place.  P. Ex. 14.  The hearsay statement of CNA 2 relayed by the administrator is of less evidentiary value than the direct eyewitness testimony provided by the surveyor.  Petitioner could have submitted a declaration under penalty of perjury from CNA 2 herself or sought her testimony via subpoena.  It did not do so.

¹⁶  Contact precautions required staff only to don gloves and a gown to enter a resident’s room and remove both before leaving, a lower level of precaution than Transmission-based precautions advised by the CDC and adopted by Petitioner for new and returning asymptomatic residents.  CMS Ex. 7 at 3. 

¹⁷  The evidence before me does not corroborate this claim.  Petitioner submitted what appears to be a one-page entry from Resident 2’s care plan that states “[Resident 2] is Moderate, risk for falls r/t Incontinence, Poor comprehension, Unaware of safety needs +H.”  P. Ex. 7.  The care plan identifies several interventions including “Follow facility fall protocol” and “Keep [Resident 2’s] door open to enable visual contact for observation except during incontinent care to maintain privacy and dignity.”  Id.  However, this entry bears a date in the upper left corner of August 12, 2020, weeks after the July 20, 2020 survey.  Id.  The Order Summary Report for Resident 2 submitted by CMS sets forth all of Resident 2’s physician’s orders in effect from his admission on July 17, 2020 to July 20, 2020.  CMS Ex. 4; see also P. Ex. 6.  Nowhere do these records indicate Resident 2’s physician ordered increased monitoring for the risk of falls.  Id. at 2-5.