Parkwood Healthcare Community, DAB CR6866 (2026)

DECISION

This case stems from two Covid-191 outbreaks at Parkwood Healthcare Community (Petitioner or facility) in August and September of 2021.  The parties agree that multiple residents and staff tested positive for Covid-19.  However, the parties disagree about, and this case generally turns on, how the facility implemented its infection prevention and control program (IPCP) in August and September of 2021.

The Texas Health and Human Services Commission (THHSC or state survey agency) determined that Petitioner, a skilled nursing facility (SNF) participating in the Medicare program, was not in substantial compliance with Medicare participation requirements because it failed to:  1) fully implement its Covid-19 IPCP when it did not place residents exposed to a Covid-positive resident in isolation or screen all visitors and staff entering the building; 2) timely inform all residents' families or representatives when one or more residents tested positive for Covid-19; 3) complete and retain Covid-19 testing documentation for residents; and 4) timely report the results of a Covid-19 investigation

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to the state survey agency.  The state survey agency also concluded that Petitioner's failure to implement its Covid-19 IPCP immediately jeopardized its residents' health and safety.

The Centers for Medicare & Medicaid Services (CMS) adopted the state survey agency's noncompliance findings and imposed two civil money penalties (CMPs) as remedial measures to ensure Petitioner's return to substantial compliance with Medicare participation requirements.  Petitioner has requested a hearing before an administrative law judge (ALJ) to dispute the findings of substantial noncompliance with the Medicare participation requirements and the imposition of CMPs.  Petitioner also challenged the immediate jeopardy determination.

As explained below, I affirm CMS's determination that Petitioner was noncompliant with 42 C.F.R. § 483.80(a)(1) as identified by the state survey agency.  Further, I conclude that CMS's determination that Petitioner's noncompliance immediately jeopardized the health and safety of Petitioner's residents was not clearly erroneous.

Finally, Petitioner did not challenge any of the regulatory factors used to determine the amounts of the CMPs in this case.  As a result, I uphold the CMPs of $12,750 per day for the 6-day period of immediate jeopardy noncompliance from September 30 through October 5, 2021, and $450 per day for the 29-day period of noncompliance from October 6 through November 3, 2021.

I.  Legal Authority

The statutory and regulatory requirements for participation of a SNF in Medicare are at section 1819 of the Social Security Act (Act) and 42 C.F.R. pt. 483.  Section 1819(h)(2) of the Act authorizes the Secretary of Health and Human Services (the Secretary) to impose enforcement remedies against a SNF for failure to comply substantially with the federal participation requirements established by sections 1819(b), (c), and (d) of the Act.2  The Act requires the Secretary to terminate the Medicare participation of any SNF that does not return to substantial compliance with participation requirements within six months of being found not to be in substantial compliance.  Act § 1819(h)(2)(C).  The Act also requires the Secretary to deny payment of Medicare benefits for any beneficiary admitted to a SNF, if the SNF fails to return to substantial compliance with program participation requirements within three months of being found not to be in substantial

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compliance – commonly referred to as the mandatory or statutory DPNA, i.e., a denial of payment for new admissions.  Act § 1819(h)(2)(D).  The Act grants the Secretary discretionary authority to terminate a noncompliant SNF's participation in Medicare, even if there has been less than six months of noncompliance.  The Act also grants the Secretary authority to impose other enforcement remedies, including a discretionary DPNA, CMPs, appointment of temporary management, and a directed plan of correction.  Act § 1819(h)(2)(B).

The Secretary has delegated to CMS and the states the authority to impose remedies against a SNF or NF that is not in substantial compliance with federal participation requirements.  42 C.F.R. §§ 488.400, 488.402(b).  "Substantial compliance means a level of compliance with the requirements of participation such that any identified deficiencies 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 sections 1819(b), (c), and (d) of the Act or the Secretary's regulations at 42 C.F.R. pt. 483, subpt. B.  Id.  The term "noncompliance" refers to any deficiency (statutory or regulatory violation) that causes a facility not to be in substantial compliance, that is, a deficiency that poses a risk for more than minimal harm to the facility's residents.  Id.  Therefore, even if a facility violates a statutory or regulatory requirement, CMS may not impose enforcement remedies if the deficiency does not pose a risk for more than minimal harm.

State survey agencies inspect, or survey, facilities that participate in Medicare on behalf of CMS to determine whether the facilities are complying with federal participation requirements.  42 C.F.R. §§ 488.10-.28, 488.300-.335.  The regulations specify the enforcement remedies that CMS may impose if a facility is not in substantial compliance with Medicare participation requirements.  42 C.F.R. § 488.406.  A CMP that is imposed against a facility on a per day basis will fall into one of two ranges of penalties.  42 C.F.R. §§ 488.408, 488.438.  The upper range of a CMP – $6,808 per day to $22,320 per day – is reserved for deficiencies that pose immediate jeopardy to a facility's residents and, in some circumstances, for repeated deficiencies.3  42 C.F.R. § 488.438(a)(1)(i), (d)(2); 45 C.F.R. § 102.3 (Table) (2020).  "Immediate jeopardy means a situation in which the provider's noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident."  42 C.F.R. § 488.301.  The lower range of CMPs – $112 per day to $6,695 per day – is reserved for deficiencies that do not pose immediate jeopardy, but either cause actual

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harm to residents, or cause no actual harm but have the potential for causing more than minimal harm.  42 C.F.R. § 488.438(a)(1)(ii); 45 C.F.R. § 102.3 (Table) (2020).

If CMS imposes a CMP based on a finding of noncompliance, then the SNF may request a hearing before an ALJ to challenge CMS's initial determination of noncompliance that led to the imposition of a remedy and/or the level of noncompliance if a successful challenge to the level would affect the range of CMP amounts imposed on the SNF or impact the facility's authority to conduct a nurse aide training and competency evaluation program (NATCEP).  42 U.S.C. §§ 1320a-7a(c)(2), 1395i-3(h)(2)(B)(ii); 42 C.F.R. §§ 488.330(e)(3)(ii), 488.408(g)(1), 488.434(a)(2)(viii), 498.3(b)(13)-(14), (d)(10); see also 5 U.S.C. §§ 554, 556.  However, CMS's choice of remedies is not reviewable.  42 C.F.R. §§ 488.438(e)(2), 488.408(g)(2), 498.3(b)(13).  When CMS imposes a CMP, an ALJ must uphold CMS's determination as to the level of noncompliance, including the finding of immediate jeopardy, "unless it is clearly erroneous."  42 C.F.R. § 498.60(c)(2); Woodstock Care Ctr., DAB No. 1726 at 9, 39 (2000), aff'd, Woodstock Care Ctr. v. Thompson, 363 F.3d 583 (6th Cir. 2003).  The Departmental Appeals Board (Board) has long held that the net effect of the regulations is that a provider has no right to challenge the scope and severity level assigned to a noncompliance finding, except when the noncompliance allegedly posed immediate jeopardy.  See, e.g., Ridge Terrace, DAB No. 1834 (2002); Koester Pavilion, DAB No. 1750 (2000).  ALJ review of a CMP is subject to 42 C.F.R. § 488.438(e).

If a SNF challenges the existence of a deficiency, CMS must make a prima facie case that the SNF failed to substantially comply with federal participation requirements and, if such a showing is made, the SNF must then prove substantial compliance by a preponderance of the evidence.  Hillman Rehab. Ctr., DAB No. 1611 at 8 (1997), aff'd, Hillman Rehab. Ctr. v. U.S. Dep't of Health & Hum. Servs., No. Civ.A. 98-3789 (GEB), 1999 WL 34813783 (D.N.J. May 13, 1999); see Batavia Nursing & Convalescent Inn, DAB No. 1911 (2004); Batavia Nursing & Convalescent Ctr., DAB No. 1904 (2004), aff'd, Batavia Nursing & Convalescent Ctr. v. Thompson, 129 F. App'x 181 (6th Cir. 2005); Emerald Oaks, DAB No. 1800 (2001).

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

Either the SNF or CMS may request that the Board review an ALJ's decision.  42 C.F.R. § 498.80; see also 5 U.S.C. § 557.

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II.  Background and Procedural History

The state survey agency completed a survey of the facility on October 6, 2021.  CMS Exs. 1-3.  Based on the survey's findings, CMS determined that Petitioner was not in substantial compliance with 42 C.F.R. §§ 483.80(a)(1), (2), (4), (e)-(f) (Tag F880), 483.80(g)(3)(i)-(iii) (Tag F885), 483.80(h)(1)-(6) (Tag F886), and 483.12(c)(1), (4) (Tag F609) at scope and severity levels of "K," "E," "E," and "D," respectively.4  CMS Ex. 2 at 1.  CMS concluded that:  1) Petitioner's violation of 42 C.F.R. § 483.80 (Tag F880) posed a risk of immediate jeopardy to Petitioner's residents from September 30 through October 5, 2021; and 2) Petitioner returned to substantial compliance with Medicare participation requirements effective November 4, 2021.  CMS Ex. 2 at 1-2; CMS Ex. 3 at 1.  CMS notified Petitioner by letter dated December 7, 2021, that it was imposing enforcement remedies, including a CMP of $12,750 per day for the 6-day period of immediate jeopardy noncompliance from September 30 through October 5, 2021, and a CMP of $450 per day for the 29-day period of noncompliance from October 6 through November 3, 2021.  CMS Ex. 3 at 1.

Petitioner timely requested a hearing before an ALJ to dispute CMS's finding of substantial noncompliance, determination of immediate jeopardy, and the imposition of two per-day CMPs.  In response, the Departmental Appeals Board's (DAB) Civil Remedies Division acknowledged receipt of the hearing request and issued ALJ Bill Thomas' Standing Prehearing Order, which established deadlines and procedures for prehearing submissions.5

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On April 26, 2022, CMS submitted a prehearing exchange, including a prehearing brief and 26 proposed exhibits (CMS Exs. 1-26).  CMS offered written direct testimony for two witnesses, Elise Q. Thomas, RN (CMS Ex. 23) and Captain (Ret.) Daniel J. McElroy, RN, BSN, BA (CMS Ex. 26).

Petitioner's prehearing exchange history is more complicated.  Petitioner filed five versions of its prehearing exchanges on May 31, July 15, August 2, August 18, and September 14, 2022.  Petitioner received multiple chances to submit filings which complied with the Standing Prehearing Order and the Civil Remedies Division Procedures (CRDP).  Petitioner has withdrawn some versions of its prehearing submission and re-filed others.  Ultimately, Petitioner submitted a prehearing exchange that included a prehearing brief and 31 proposed exhibits (P. Exs. 1-31).  Petitioner offered written affidavits or statements for three individuals:  Soroush Behnam, M.D. (P. Ex. 10); Akash Bhatia, LNFA (P. Ex. 30); and Averose Pastores, RN (P. Ex. 31).  Petitioner only listed Akash Bhatia, LNFA and Averose Pastores, RN as proposed witnesses.6  See P. Witness List, DAB E-Filing No. 17_a.

As noted above, at the inception of this case, ALJ Thomas issued an order establishing the rules that addressed, among other things, the exchange by the parties of briefs and exhibits.  Paragraph 11 of the Standing Prehearing Order directs the parties to reduce all proposed testimony to writing made under oath or as a declaration made under penalty of perjury.  Paragraph 12 addresses possible cross-examination of witnesses, stating:  a request for cross-examination must be in the form of a notice "in a distinct, stand-alone filing which identifies a witness or witnesses it desires to cross-examine."

The parties have not submitted any requests for cross-examination that comply with the requirements set forth by ALJ Thomas' Standing Prehearing Order.  The purpose of the Standing Prehearing Order is to narrow the focus of any hearing that may be conducted in the case and to enable the ALJ to plan for the possible length of the hearing.  As such, because the direct testimonies for those witnesses are already in the record, and because no witnesses will be cross-examined, an in-person hearing would serve no purpose.  Standing Prehearing Order at ¶¶ 10, 13, 16.  I will therefore decide this matter based on the written record.  HeartFlow, Inc., DAB No. 2781 at 16-17 (2017) (citing Vandalia Park, DAB No. 1940 at 28-29 (2004), aff'd, Vandalia Park v. Leavitt, 157 F. App'x 858 (6th Cir. 2005)).7

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III.  Evidentiary Rulings

Petitioner's Proposed Exhibits

Due to Petitioner's various withdrawals and re-filings, I must first untangle which exhibits and DAB E-Filing docket numbers are the final versions Petitioner offers for admission.  Petitioner filed final versions of its proposed exhibits on August 2, August 18, and September 14, 2022.  To eliminate confusion, I list the final version of Petitioner's proposed exhibits and the coordinating DAB E-Filing docket numbers in the below table:

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Petitioner's Motion to Supplement its Witness List and CMS's Objection to P. Ex. 10

Petitioner's January 10, 2022 request for hearing (RFH) lists "Dr. Soursh [sic] Behnam, MD" as the second of four witnesses it intended to call.  See DAB E-Filing Docket No. 1 at 3.  While Dr. Benham was not included as a witness on Petitioner's subsequently filed witness list that accompanied its pre-hearing exchange, Petitioner did include, as an exhibit, Dr. Benham's affidavit.  See P. Exhibit List; P. Ex. 10.

CMS, however, objects to Petitioner's request to supplement its prehearing exchange to include Dr. Benham as a witness.  See DAB E-Filing Docket No. 24.  In its objection, CMS argues that Petitioner should not be permitted to supplement its witness list without explanation or good cause.  Id.  CMS has also objected to various iterations of Dr. Benham's testimony submitted by Petitioner.9  Specifically, CMS objected to the August 18, 2022 version of P. Ex. 10 (DAB E-Filing Docket No. 21d) on the grounds that the letter offered as a written declaration did not qualify as a statement made under oath or under penalty of perjury, that the exhibit did not sufficiently identify the witness's name, and that the notarization was not signed.  See CMS Objs. at 1-2.  CMS further objected to P. Ex. 10 because Petitioner did not identify the document's author as a proposed witness.  Id. at 2.  Finally, CMS requests that I exclude P. Ex. 10 if the author is not available for cross-examination.  Id.

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Petitioner filed a revised version of P. Ex. 10 on September 14, 2022 (DAB E-Filing Docket No. 23a).  It argues that this version renders CMS's objection to the notary signature moot and that the document complies with the Standing Order's requirements for written direct testimony.  See P. Resp. to CMS Objs. at 1.  Petitioner also included a request to supplement its exchange to add the author of P. Ex. 10 to its witness list.  Id. at 2.  On September 19, 2022, CMS filed Objections to Petitioner's Request to Supplement Prehearing Exchange and renewed its objection to P. Ex. 10.  DAB E-Filing Docket No. 24.

I find good cause to admit Petitioner's submissions and overrule CMS's objection.  CMS urges me to preclude a document for which it submitted into the record (CMS's own Ex. 16 is the exact same letter from Dr. Benham that Petitioner is seeking to admit, albeit not as testimony) and exclude a witness it has had notice Petitioner intended to offer from the initial request for hearing.  I decline to define "good cause" narrowly, particularly when CMS seeks its application against an unrepresented non-governmental party that lacks the resources CMS brings to bear at every level of the appeals process.  Moreover, Petitioner's request to supplement its submission in no way prejudices CMS, which as I explain below, does not change the outcome here.

CMS Objections to P. Exs. 1, 21, 22

CMS objected to P. Exs. 1, 21, and 22.  See Respondent's Objections to Petitioner's Exhibits (CMS Objs.), DAB E-Filing Docket No. 22.  As explained below, I sustain CMS's objections and exclude P. Exs. 1, 21, and 22 from the record.

P. Exs. 1, 22

CMS objected to P. Exs. 1 and 22 on the grounds that they duplicate exhibits previously filed by CMS.  Specifically, CMS argues P. Ex. 1 duplicates CMS Ex. 1 and P. Ex. 22 duplicates CMS Ex. 5.  See CMS Objs. at 1, 2.

Petitioner concedes P. Exs. 1 and 22 are duplicative of CMS's exhibits and does not offer any arguments in opposition.  See P. Resp. to CMS Objs. at 1, 2, DAB E-Filing Docket No. 23.  As a result, I sustain CMS's objections to P. Exs. 1 and 22 and exclude them from the record.

P. Ex. 21

CMS objected to P. Ex. 21 on the grounds that enforcement documents pertaining to other facilities are irrelevant to this proceeding.  See CMS Objs. at 1-2.

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Petitioner concedes P. Ex. 21 concerns another facility, but argues this is evidence CMS imposed an "unusually aggressive" and unreasonable scope and severity deficiency for the period of September 30 through October 6, 2021.  See P. Resp. to CMS Objs. at 1-2.

In these proceedings, I must receive into evidence any testimony and documents that are relevant and material.  42 C.F.R. § 498.60(b)(1); see 5 U.S.C. § 556(d).  I am required to "inquire[] fully into all of the matters at issue" and admit any documents that are relevant and material.  42 C.F.R. § 498.60(b).  As discussed below, Petitioner bears the heavy burden to show that CMS's determination that Petitioner's noncompliance under 42 C.F.R. § 483.80 posed immediate jeopardy to its residents from September 30 through October 5, 2021, was clearly erroneous.  The level of noncompliance, i.e., scope and severity, is subject to review only if a successful challenge would:  1) affect the amount of CMP that may be imposed, i.e., the higher range of CMP authorized for immediate jeopardy; or 2) affect a finding of substandard quality of care that rendered the facility ineligible to conduct a NATCEP.  42 C.F.R. § 498.3(b)(14), (d)(10)(i).  The regulations leave the decision regarding the choice of remedy to CMS, and the amount of the remedy to CMS and the ALJ, requiring only that the regulatory factors at sections 488.438(f) and 488.404 be considered when determining the amount of a CMP within a particular range.  42 C.F.R. §§ 488.408, 488.408(g)(2), 498.3(d)(11); see 42 C.F.R. § 488.438(e)(2)-(3); Alexandria Place, DAB No. 2245 at 27 (2009); Kenton Healthcare, LLC, DAB No. 2186 at 28-29 (2008).  I have no discretion to review CMS's exercise of discretion to impose a CMP or to consider any factors other than those in 42 C.F.R. §§ 488.438(f), 488.404.  42 C.F.R. § 488.438(e)(2).  Those factors are facility- and fact-specific and comparisons to other cases are of limited to no value.

I conclude that CMS's determinations regarding another facility's noncompliance during the time period of Petitioner's alleged noncompliance, which CMS argues immediately jeopardized the health and safety of Petitioner's residents, are neither relevant nor material to the issues I have been tasked with reviewing, i.e., whether CMS's determination of immediate jeopardy was clearly erroneous or whether the CMPs imposed are reasonable.  As a result, I sustain CMS's objections to P. Ex. 21 and exclude it from the record.

I sustain CMS's objections and exclude P. Exs. 1, 21, and 22 from the record.  In the absence of further objections, I admit P. Exs. 2-20 and 23-31 (DAB E-Filing Docket Nos. 17_d-17_g, 21, 21_a-21_j, 17_s-17_v, 17_y-17_z, 21_k-21_o, 17_a6, and 21_n), and CMS Exs. 1-26 into the record.

IV.  Issues

1. Whether Petitioner was in substantial compliance with Medicare participation requirements at 42 C.F.R. §§ 483.80(a)(1)-(2), (4), (e)-(f), 483.80(g)(3)(i)-(iii), 483.80(h)(1)-(6), and 483.12(c)(1), (4).

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2. If Petitioner was not in substantial compliance with 42 C.F.R. § 483.80(a)(1)-(2), (4), (e)-(f), whether that deficiency immediately jeopardized the health and safety of Petitioner's residents.
3. If Petitioner was not in substantial compliance with 42 C.F.R. § 483.80(a)(1)-(2), (4), (e)-(f), whether a $12,750 per-day CMP for six days of immediate jeopardy level noncompliance is reasonable under the factors in 42 U.S.C. § 1320a-7a(d) and 42 C.F.R. § 488.438(f).
4. If Petitioner was not in substantial compliance with 42 C.F.R. §§ 483.80(a)(1)-(2), (4), (e)-(f), 483.80(g)(3)(i)-(iii), 483.80(h)(1)-(6), and 483.12(c)(1), (4), whether a $450 per-day CMP for 29 days of non-immediate jeopardy level noncompliance is reasonable under the factors in 42 U.S.C. § 1320a-7a(d) and 42 C.F.R. § 488.438(f).

V.  Findings of Fact, Conclusions of Law, and Analysis10

1. At the time of the survey, SNFs were required to establish and maintain infection prevention control programs to help prevent spreading Covid-19 throughout their facilities.

Regulatory Requirements for Infection Prevention and Control

The Act and its implementing regulations require SNFs like Petitioner to "establish 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) (emphasis added); 42 C.F.R. § 483.80.  42 C.F.R. § 483.80 requires:

(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

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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.

* * * *

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

* * * *

(f) Annual review.  The facility will conduct an annual review of its IPCP and update their program, as necessary.

Under 42 C.F.R. § 483.80(a)(1), Petitioner's IPCP must be consistent with national standards, at least some of which are in evidence in this case.  The Secretary and CMS do not dictate the national standards applicable.  CMS specifically decided not to incorporate the Centers for Disease Control and Prevention (CDC) guidelines by reference in the infection control regulation at 42 C.F.R. § 483.80, stating:

We believe that facilities need the flexibility to determine which national standard they are going to follow.  We also believe it is appropriate for the different types of national standards that are acceptable to CMS to be included in the sub-regulatory guidance for this rule.  Although we are not requiring that LTC [long term care] facilities follow the CDC guidelines, we agree with the commenters that the CDC is an excellent resource for guidelines, as well as other information on infection control, and encourage LTC facilities to consider the CDC guidelines.

81 Fed. Reg. 68,688, 68,808 (Oct. 4, 2016).  CDC guidelines do not have the force and effect of law because they are not promulgated as regulations.  Cf. Azar v. Allina Health Servs., 587 U.S. 566, 139 S. Ct. 1804 (2019).  Rather, CDC guidelines are evidence of a standard of practice that CMS has found acceptable.

CMS gives facilities significant discretion to develop and implement infection control protocols consistent with professionally recognized standards of nursing care.  Upon establishing such policies and protocols, a facility is then required to implement those protocols and ensure they are effective.  42 C.F.R. § 483.80(a)(1)11; Golden Living Ctr. – Superior, DAB No. 2768 at 5, 7 (2017); Heritage House of Marshall Health & Rehab. Ctr., DAB No. 2566 at 12 (2014).  See also Rockcastle Health & Rehab. Ctr., DAB No. 2891 at 19 (2018) (ruling that, absent contrary evidence, it is reasonable to presume that

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the facility's policies reflect professional standards); Bivins Mem'l Nursing Home, DAB No. 2771 at 9 (2017); Hanover Hill Health Care Ctr., DAB No. 2507 at 6 (2013); Life Care Ctr. of Bardstown, DAB No. 2233 at 21-22 (2009) (finding that a facility's failing to comply with its own policies can constitute a deficiency).

CDC Guidance:  Mitigating Covid-19

At the outset of the Covid-19 pandemic, CMS advised nursing homes to rely on information and resources provided by the CDC and their local health departments to mitigate the spread of Covid-19.  CMS, 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 visited March 26, 2026).

On April 2, 2020, CMS issued guidelines to help nursing homes implement the CDC's infection control recommendations in key areas, including implementing symptom screening for individuals entering SNFs; cohorting residents and staff based on their Covid-19 status; and properly using hand hygiene and personal protective equipment (PPE).  See CMS Ex. 6.  The guidance recommended nursing homes implement immediate actions to protect their residents:

• In accordance with previous CMS guidance, every individual regardless of reason entering a long-term care facility (including residents, staff, visitors, outside healthcare workers, vendors, etc.) should be asked about COVID-19 symptoms and they must also have their temperature checked.  An exception to this is Emergency Medical Service (EMS) workers responding to an urgent medical need.  They do not have to be screened, as they are typically screened separately.
• Facilities should limit access points and ensure that all accessible entrances have a screening station.
• In accordance with previous CDC guidance, every resident should be assessed for symptoms and have their temperature checked every day.
• Patients and residents who enter facilities should be screened for COVID-19 through testing, if available.

Id. at 2.  CMS recommended facilities separate Covid-19 negative residents from Covid-19 positive residents and individuals with unknown Covid-19 status (cold, hot, and warm zones).  Id. at 2-3.  Finally, CMS reminded facilities to adhere to appropriate CDC hand hygiene and infection control guidance.  Id. at 1.

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On November 20, 2020, the CDC issued updated guidance on screening visitors for fever, symptoms consistent with Covid-19, or known exposure to someone with Covid-19 as well as restricting visitors with fever, symptoms, or known exposure from entering the facility.  CMS Ex. 4 at 4.  The guidance also instructed facilities to screen all staff at the beginning of their shift for fever and Covid-19 symptoms, which included taking staff's temperature and documenting the absence of Covid-19 symptoms.  Id. at 5.

On February 23, 2021, the CDC updated its guidance, instructing facilities to limit and monitor entry points to the facility, to screen everyone entering the facility for Covid-19 symptoms or exposure to others with suspected or confirmed Covid-19, and to reinforce universal source control measures for residents, healthcare personnel, and visitors.  See CMS Ex. 22 at 2, 4.

THHSC Guidance:  Screening Facility Entrants and Responding to Covid-19 Cases

On July 20, 2021, THHSC issued a document titled "Covid-19 Response for Nursing Facilities."  CMS Ex. 5.  This document revised its April 2020 guidance document issued to nursing facilities to assist them with identifying and responding to positive Covid-19 cases; preventing further spread of Covid-19 within SNFs; caring for residents who contract Covid-19; protecting residents, staff, and visitors from Covid-19; and preventing, managing, and reporting Covid-19 outbreaks.  CMS Ex. 5.  The THHSC guidance mirrors the CDC's visitor and staff screening requirements.  Id. at 33, 43.  It incorporates CMS's April 2, 2020 guidelines, CDC's November 20, 2020 guidance, and CDC's February 23, 2021 guidance discussed above and filed as CMS Exs. 4, 6, and 22.  Id. at 71, 72.  Petitioner concedes it adopted this guidance as a "primary guide" for its own policies and procedures, due to rapidly changing Covid-19 recommendations.  P. Br. at 6-7; P. Ex. 30 at 1.

The THHSC guidance requires facilities to actively screen, monitor, and surveil everyone who enters the building.  CMS Ex. 5 at 18, 33, 43, 67.  Specifically, facilities were required to screen all staff prior to entering the facility at the beginning of their shifts, including taking their temperature and documenting the absence of Covid-19 symptoms such as "shortness of breath, new or change in cough, sore throat and other symptoms . . . ."  Id. at 33, 43.  If staff presented as ill during screening, facilities were instructed to have staff put on a face mask, immediately leave the facility, and self-isolate at home.  Id.  Screening logs should include names of all visitors, their current contact information, and the presence or absence of symptoms.  Id. at 33.

The THHSC guidance directed facilities to create a plan to cohort residents based on their Covid-19 status:  Covid-19 positive, Covid-19 negative, and unknown Covid-19 status.  CMS Ex. 5 at 18-19, 37, 55.  Facilities were instructed to create an isolation wing or unit to separate their Covid-19 positive residents from their Covid-19 negative or untested and asymptomatic residents, as practicable.  Id. at 28.  As soon as a resident tests positive for

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Covid-19, the THHSC guidance instructs facilities to take immediate action to isolate the resident.  Id. at 37, 68.  Facilities should move exposed roommates into quarantine and monitor them for fever and symptoms for 14 days.  Id. at 19, 37.  Residents who are fully vaccinated, asymptomatic, and have not had prolonged close exposure to someone with Covid-19 do not need to quarantine.  Id. at 19 (emphasis added).  Once an outbreak (one or more laboratory confirmed cases of Covid-19 or one or more cases of respiratory illness within a one-week period without a positive Covid-19 test) is identified, facilities must implement universal use of face masks for health care workers inside the facilities.  Id. at 54-55.  Finally, facilities are instructed to reinforce with staff the importance of compliant hand hygiene; properly using PPE; and using and understanding cold, warm, and hot zones within the facility.  Id. at 18-20, 44-45.

2. At the time of the survey, Petitioner had an IPCP in place related to Covid-19.  Among other requirements, the IPCP provides that residents with symptoms of Covid-19 or those exposed to Covid-19 should be cohorted or placed on transmission-based precautions to help prevent spreading Covid-19 throughout the facility.

Petitioner's Covid-19 Policy

CMS and Petitioner both submitted copies of Petitioner's Covid-19 policy.  Titled "Coronavirus Disease (COVID-19) – Identification and Management of Ill Residents," and last revised in July of 2020, Petitioner's Covid-19 policy includes requirements for screening and monitoring residents; resident placement and cohorting; surveilling and reporting respiratory illness; and using appropriate infection prevention and control measures when providing clinical care to residents.  CMS Ex. 7; P. Ex. 17.

Petitioner's Covid-19 policy required residents to be placed, cohorted, and transferred as follows:

Resident Placement and Cohorting

1. Residents with suspected COVID-19 are placed in a private room, moved to a dedicated unit, or cohorted with another resident who is suspected to have COVID-19 pending the results of SARS-CoV-2 testing.
2. Residents with confirmed COVID-19 are separated from residents who do not have confirmed COVID-19, or have an unknown status.  Dedicated units must be able to adhere to strict infection control practices.

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3. Consistent staff assignments are exercised for all residents regardless of symptoms or COVID-19 status.  Staff members are not assigned to work across floors or units when possible.
4. Residents with known or suspected COVID-19 are cared for using all recommended PPE, including an N95 or higher level respirator (or facemask if respirators are not available), eye protection, gloves and gown.
5. Residents who may have been exposed to someone with COVID-19 are monitored closely and not placed with unexposed residents until 14 days after exposure or until status of COVID-19 is determined.

* * * *

Transfers

1. Residents with suspected or confirmed COVID-19 who have fever and/or respiratory symptoms are not automatically transferred to the hospital if their clinical condition and symptoms can be managed at the facility.
2. For the resident who develops severe symptoms of illness and requires transfer for a higher level of care:

a. Emergency medical services and the receiving facility are alerted of the resident's diagnosis (suspected or confirmed COVID-19) and notified of precautions to be taken (transferring and receiving staff); and

b. facemask is placed on the resident during transfer (as supply allows).

* * * *

5. For residents who need to leave the facility for medically necessary purposes (e.g. dialysis, etc.),

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the transportation and receiving health care team is notified of the resident's suspected or confirmed COVID-19 status.  Regardless of COVID-19 status, a facemask is placed on the resident prior to leaving his or her room.

CMS Ex. 7 at 2-3; P. Ex. 17 at 2-3.  When accepting resident admission from hospitals, Petitioner's Covid-19 policy required specific responses depending on the new-admission's Covid-19 status:

2.  For patients/residents who are tested prior to hospital discharge and are COVID-19 negative (including those who were COVID-19 positive and recovered), ADMIT and:

a.  cohort (in rooms or wings) with other residents of similar status (e.g., new hospital admissions with negative COVID-19 test, etc.), if possible;
b.  monitor temperature and respiratory symptoms every shift;
c.  limit contact with other residents (as much as possible); and
d.  consistently assign staff and limit number of times staff enter resident room.

3.  DO NOT ADMIT patients who have not been tested in the hospital prior to discharge (status unknown) or patients who are presumptive or confirmed COVID-19 positive UNLESS:

a.  There is a dedicated unit or floor in the facility for COVID-19 residents;
b.  Staff movement between units is limited as much as possible; and
c.  There are adequate staffing levels and PPE to manage COVID-19 positive residents.

4.  For any resident admitted from the hospital with unknown status:

a.  Place in a single room or observation area;
b. Restrict access to other residents to the extent possible;

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c.  Monitor temperature and respiratory symptoms every shift;
d.  Place on contact and droplet precautions and wear recommended PPE when caring for the resident; and
e. Consistently assign staff and limit number of times staff enter resident room.

CMS Ex. 7 at 3-4; P. Ex. 17 at 3-4.

3. At the time of the survey, Petitioner had a Covid-19 screening tool for staff and visitors to complete each time they entered the facility.  The screening tool assesses symptoms and potential exposure risks and recommends whether to admit or deny entry to the facility based on the responses.  

Petitioner's Covid-19 Screening Process

The regulation describes in detail the systems and measures that SNFs must adopt as an IPCP.  42 C.F.R. § 483.80(a)(1)-(2).  SNFs must develop and implement a system of surveillance that is designed to identify possible communicable diseases or infections before they can spread to others in the facility.  42 C.F.R. § 483.80(a)(2)(i).  SNFs must also identify when and to whom possible incidences of communicable disease or infection must be reported.  42 C.F.R. § 483.80(a)(2)(ii).  Any system that the SNF adopts must comport with accepted national standards.  42 C.F.R. § 483.80(a)(1).

Petitioner submitted a document it represents is the system it used to comply with the Covid-19 screening requirements of its IPCP.  P. Ex. 18.  Using an online questionnaire through Quixi, the system asks the entrant a series of questions, beginning with their relationship to the facility.  Id. at 1.  The system then prompts the entrant to self-report if they are experiencing a series of symptoms related to Covid-19 and if they have had a list of previous types of exposure risks.  Id. at 2-3.  After completing the questionnaire, the system directs the entrant to have their temperature taken at the reception desk, if the location did not use a kiosk that could take temperature readings.  Id. at 4.  According to P. Ex. 18, the system will calculate a "FACETT" risk score to recommend whether the facility should allow entry.  Id. at 5.  "FACETT" is calculated based on six key Covid-19 symptoms:  fever, aches, cough, exposure, travel, and tired (fatigue).  See CMS Ex. 25 at 1; P. Ex. 2 at 1.

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4. In August of 2021, two of Petitioner's residents, Resident 1 (R1) and Resident 3 (R3), were roommates.  Shortly after R1's return from a visit to the emergency room, he tested positive for Covid-19.  R3 was placed on isolation protocols due to his exposure to Covid-19 as R1's roommate, but he continued to receive in-person visits.  Five days after R1's diagnosis, R3 tested positive for Covid-19.

R1

In August of 2021, R1 was a resident of Petitioner's facility receiving skilled nursing and rehabilitation services following diagnoses of acute encephalopathy and a right humerus fracture.  CMS Ex. 8 at 7-8.  On August 6, he was sent to the emergency room for assistance with a malfunctioning Foley catheter.  Id. at 2.  He returned to Petitioner's facility in the early hours of August 7, but returned to the emergency room later that same day after he had an unwitnessed fall and started displaying increased confusion.  Id. at 1-2.  After an overnight stay at the emergency room, he returned to Petitioner's facility on August 8.  Id. at 1.  Approximately four hours later, he tested positive for Covid-19 and Petitioner discharged him from the facility to the emergency room.  Id.; P. Ex. 26 at 1; P. Ex. 27.

Petitioner submitted a Covid-19 test results spreadsheet, which describes the "possible transmission" (i.e., source of infection) for each of its residents who contracted Covid-19 while they were in the facility.  P. Ex. 25 at 5.  For R1, the spreadsheet says:  "No positive staff identified prior in routine testing – possibl[e] family/hospital exposure.  Family never identified.  Sent out 8/6 to hsp."  Id.; see also P. Br. at 4 (conceding R1 exposed his roommate to Covid-19 upon R1's return from the hospital).

R3

On August 5, 2021, R3 was admitted to Petitioner's facility for skilled nursing and rehabilitation services following a diagnosis of acute respiratory failure with hypoxia.  CMS Ex. 9 at 5.  He was admitted with no signs or symptoms of cough, fever, fatigue, or sore throat.  Id.  Petitioner placed R3 in room 203, bed A, of Petitioner's Nursing Front Hall.  CMS Ex. 17 at 5-6.  This meant he and R1 were roommates, because R1 had bed B in room 203.  Compare CMS Ex. 17 at 5-6, with CMS Ex. 17 at 1-4.

Following R1's positive Covid-19 result, staff tested R3 for Covid-19.  CMS Ex. 9 at 4.  R3's first test was negative, but he was placed on isolation protocols in his room due to his exposure to Covid-19 as R1's roommate.  Id.; P. Ex. 6; P. Ex. 28.  On August 10, Petitioner's dietary manager visited R3, who was on isolation protocols.  CMS Ex. 9 at 3; P. Ex. 29.  On August 11, Petitioner re-tested R3 for Covid-19, which was negative.  CMS Ex. 9 at 2.  Later that day, R3 attended a care plan meeting with several staff members and his wife, who was not a resident of Petitioner's facility.  Id.  On August 12, a progress note reports R3 having diarrhea the night of August 11.  Id. at 1; P. Ex. 26 at 3.

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There is no mention of monitoring for any other signs or symptoms of Covid-19, but staff planned to start C. diff protocols if the diarrhea did not resolve.  Id.  On August 13, a progress note indicates R3 was "still complaining of occasional dry cough, not as bad as yesterday."  Id.  On August 13, R3 returned two positive Covid-19 tests and Petitioner discharged R3 from the facility to the hospital.  Id.

Petitioner's Covid-19 test results spreadsheet of its residents who contracted Covid-19 while they were in the facility attributes "Roommate of [R1]" as the possible source of R3's Covid-19 infection.  P. Ex. 25 at 5.

5. Petitioner was not in substantial compliance with infection control regulations at 42 C.F.R. § 483.80(a)(1) (Tag F880) because facility staff failed to maintain or implement Petitioner's IPCP.  Although Petitioner removed one Covid-positive resident from the facility, it failed to implement Petitioner's IPCP that required confirmed Covid-19 positive residents to be separated from those with negative or unknown status.  Petitioner also failed to monitor residents for signs and symptoms of Covid-19 for a new admission and upon return from an overnight stay in the emergency room, which risked spreading Covid-19 in the facility.

Facilities were directed to actively monitor all residents upon their admission at least three times daily for fever and respiratory symptoms, including shortness of breath, new or changed cough, sore throat, and oxygen saturation.  CMS Ex. 5 at 35.  Petitioner's Covid-19 policy required all residents to be monitored at least daily for signs and symptoms of Covid-19.  CMS Ex. 7 at 1; P. Ex. 17 at 1.  Any resident who left the facility overnight should have been treated as having an unknown Covid-19 status and monitored upon their return.  CMS Ex. 5 at 19, 36, 43.  Residents leaving the facility also should have been screened at the entrance like any other staff or visitor.  Id. at 42-43.  If a resident tests positive for Covid-19, their exposed roommate should be moved and monitored for fever and Covid-19 symptoms at least three times daily for 14 days.  Id. at 37.  Petitioner's residents with confirmed Covid-19 must be separated from those who do not have Covid-19, even those with an unknown status.  CMS Ex. 7 at 2; P. Ex. 17 at 2.  Petitioner's residents who may have been exposed to someone with Covid-19 must be monitored closely for 14 days or until their Covid-19 status is determined.  Id. at 3.

Petitioner argues that the record shows R3 was on isolation protocols and that it did follow its IPCP.  P. Br. at 2 (citing P. Exs. 5, 26).  Moreover, the record indicates that there is an order for isolation and droplet precautions on August 8, after R1 tested positive for Covid-19.  P. Exs. 6 at 1, 28 at 1.  There are also progress notes on August 11, 12, and 13 indicating "Droplet precaution observed," (CMS Ex. 9 at 2) "Droplet precaution in place[] and enforced," (CMS Ex. 9 at 1) and "Droplet precautions observed" (CMS Ex. 9 at 1; P. Ex. 26 at 3).

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However, the record before me is devoid of any evidence that Petitioner monitored R1 or R3 for signs and symptoms of Covid-19 as required by its IPCP.  See CMS Exs. 8, 9, 17; P. Exs. 6, 28, 29.  As a new admission, R3 already required monitoring at least three times daily due to his unknown Covid-19 status.  See CMS Ex. 9 at 5 (noting R3's status as a new admission); CMS Ex. 5 at 35 (new admission monitoring requirements).  R3 was admitted with hypoxia, was unable to lay flat due to shortness of breath, and received supplemental oxygen.  CMS Ex. 9 at 4, 5.  It was crucial to monitor him due to his status as a new admission and his hypoxia causing a baseline shortness of breath, which could be confused with or disguise a symptom of Covid-19.

R1 left the facility overnight from August 7 to August 8, when he was transferred to the emergency room for assistance with his Foley catheter.  CMS Ex. 8 at 1.  When he returned to the facility, he needed to be screened at the entrance, and he needed to be monitored closely because his Covid-19 status changed to "unknown."  CMS Ex. 5 at 19, 42-43.  Once R1 tested positive for Covid-19, Petitioner needed to separate him from R3.  CMS Ex. 7 at 2; P. Ex. 17 at 2.  Further, Petitioner needed to ensure that R3 was still being monitored for signs and symptoms of Covid-19 at least three times daily, and if he was not, they needed to start monitoring him.  CMS Ex. 5 at 37.

Instead, there is no evidence Petitioner monitored R1 for Covid-19 symptoms after his return from an overnight visit to the emergency room.  P. Exs. 26, 27; CMS Ex. 8 at 1.  There is no evidence that Petitioner screened R1 upon his return from either trip to the emergency room.  CMS Exs. 24, 25; P. Ex. 2.  Petitioner also did not separate R1 from R3 upon confirming R1's positive Covid-19 diagnosis.  See CMS Ex. 17.

For R3, notes of vitals or monitoring for shortness of breath or other possible Covid-19 symptoms are limited to his admission on August 6 (CMS Ex. 9 at 5) and maybe once per day:  August 8 (id. at 4), August 9 (id.), August 10 (id. at 3), and August 11 (id.).  There are no notes of Covid-19 monitoring for August 12, despite R3 reporting new diarrhea which started on August 11.  Id. at 1-2.  The first mention of a dry cough was on August 13, when he tested positive for Covid-19.  Id. at 1.  However, the note says R3 was "still complaining of occasional dry cough, not as bad as yesterday."  Id. (emphasis added).  There is no note from August 12 reporting a dry cough, despite a Nurse Practitioner ordering a chest X-ray.  Id.

After R1 returned to the facility after an overnight visit in the emergency room, Petitioner did not screen R1 or monitor him for signs and symptoms of Covid-19 at least three times daily.  Petitioner did not monitor R3 for signs and symptoms of Covid-19 upon his new admission to the facility.  After R1, who was R3's roommate, tested positive for Covid-19 on August 8, Petitioner did not separate him from R3 or begin increased monitoring on R3 for signs and symptoms of Covid-19.  R3 had a baseline shortness of breath due to hypoxia and started experiencing diarrhea on the evening of August 11 and a new dry cough on August 12.  Id. at 5.  Petitioner's staff did not note or report either of these new

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symptoms of Covid-19 until the following day or when additional interventions such as a chest X-ray or potential C. diff. droplet precautions were ordered or considered.  Id. at 1.  As a result, Petitioner's staff did not fully implement Petitioner's IPCP and I conclude that Petitioner was not in substantial compliance with 42 C.F.R. § 483.80(a)(1) (Tag F880).

6. Petitioner was not in substantial compliance with infection control regulations at 42 C.F.R. § 483.80(a)(1) (Tag F880) because facility staff failed to maintain or implement Petitioner's IPCP.  Petitioner failed to screen visitors or staff for signs and symptoms of Covid-19 before admitting them to the facility, which risked spreading Covid-19 in the facility.

The Statement of Deficiencies (SOD) alleged that during the survey, the surveyor observed Petitioner failing to screen two emergency medical technicians (EMTs) for signs and symptoms of Covid-19 when they entered the facility for a non-emergency transport.  CMS Ex. 1 at 7.  The SOD alleged that when the surveyor reviewed Petitioner's screening logs for August and September of 2021, the logs showed that from August 8 through September 30, 2021 Petitioner did not screen staff for signs and symptoms of Covid-19 when they entered the facility.  Id. at 7.  The SOD also alleged that Petitioner failed to obtain and log complete screening results for visitors in August, September, and October of 2021.  Id. at 8.  The surveyor interviewed one of Petitioner's staff members, who was responsible for screening all visitors during her shifts.  Id. at 9.  The staff member conceded that while she took all visitors' temperatures, she did not always complete the full screening.  Id.  The SOD also includes the staff member's statement that there is no negative outcome for Petitioner's residents if visitors are not screened every time they enter the facility.  Id.  Finally, the surveyor interviewed the facility's administrator, who conceded that Petitioner did not have a policy regarding which entrances should be used for entry, screening, or monitoring visitation.  Id.

The evidence in the record shows that Petitioner did not begin using the Quixi questionnaire system for staff until September 6, 2021.  Compare CMS Ex. 24, with CMS Ex. 25 and P. Ex. 2.  The staff screening log from August 1 through September 30, 2021 includes results for temperature, oxygen saturation, domestic and international travel, and work at another facility (presumably healthcare).  See CMS Ex. 24 at 1.  However, there are no columns for aches, cough, fatigue, or additional exposure risks such as social gatherings, close contact with someone else who tested positive for Covid-19, or travel on an airplane or a cruise.  Id.; see also P. Ex. 18 at 3 (additional exposure risks).  Both screening logs also contain a substantial number of entries where the full names are not provided and the entries are either initials or only one name.  See CMS Exs. 24, 25; P. Ex. 2.

Petitioner asserts that the surveyor failed to ask for more specific screening documentation until after the surveyor cited the immediate jeopardy condition.  See P. Br.

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at 1-2, 4.  Petitioner does not dispute that it began using the Quixi screening system for staff on September 6, 2021.  Id. at 2.  In fact, it confirms that P. Ex. 2 is the full report.  Id. at 4.  Petitioner does not dispute the surveyor's observation that EMTs were not screened upon entry to the facility for a non-emergency transport.  Id.  Petitioner also does not dispute the statements by one of its staff members that she was not ensuring she completely screened every staff and visitor, every time, or by the administrator that Petitioner does not have a policy on which entrances to use for entry or for screening staff or visitors.  See P. Br. at 1-2, 4.  When statements are made by the facility's own employees, and those individuals have not refuted them, they may constitute substantial evidence.  See Beatrice State Developmental Ctr., DAB No. 2311 at 17, 18 (2010) (pointing out that the facility did not, but could have presented employee testimony that refuted the statements the surveyors claimed they made); Omni Manor Nursing Home, DAB No. 1920 at 11 (2004) (holding that facility employee statements may be admitted in an administrative proceeding and may constitute substantial evidence).

Petitioner's Covid-19 screening tool relied almost entirely on self-reporting by staff members and visitors.  A single failure to check a temperature, to record it, and/or to report Covid-19 symptoms leaves a gaping hole in the system.  The screening tool's dependence on self-reporting required Petitioner's receptionist to meticulously review it as soon as staff members and visitors attempted to enter the facility.  The receptionist not only had to look for potential Covid-19 symptoms among staff and visitors, but also had to make sure that everyone accurately and carefully reported their symptoms.  Any failure by staff or visitors to report their symptoms, any failure by the receptionist to take a temperature, and any failure to watch other entrances to ensure 100% of the entrants were screened meant that potentially infected individuals might enter the facility premises undetected.  Likewise, any failure to review the screening tool promptly and carefully meant that an infected staff member or visitor might slip through the cracks and come in direct contact with residents – with potentially lethal consequences for those vulnerable individuals.  Finally, a failure to capture complete contact information for facility visitors prevented accurate contact tracing in the event of an outbreak.

Between August 8 and October 4, 2021, 18 residents and 15 staff tested positive for Covid-19.  CMS Ex. 1 at 8.  Having experienced two Covid-19 outbreaks during that time, it was essential for Petitioner to fully comply with all provisions of its IPCP to prevent spreading Covid-19 further.  However, the record shows that Petitioner did not correctly use the Covid-19 screening tool because there was not a full screening for every visitor and staff member who entered the facility from August 1 through September 5, 2021.  As a result, Petitioner's staff did not fully implement Petitioner's IPCP and I conclude that Petitioner was not in substantial compliance with 42 C.F.R. § 483.80(a)(1) (Tag F880).

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7. Petitioner was not in substantial compliance with infection control regulations at 42 C.F.R. § 483.80(a)(1) (Tag F880) because facility staff failed to maintain or implement Petitioner's IPCP.  Facility staff failed to properly wear an N95 mask and use appropriate hand hygiene when involved in direct resident contact, which risked spreading Covid-19 in the facility.

The SOD alleged the following incidents occurred:

An observation on [September 30, 2021] at 1:40 pm revealed CNA N was sitting in the resident dining room with a[n] N95 mask below her chin, not covering her nose and mouth. . . .  CNA N revealed the expectation of staff was to always wear N95 mask that covers the nose and mouth.

An observation on [September 30, 2021] at 5:06 pm revealed Porter O with [an] N95 mask below his chin, not covering nose and mouth, while talking on the phone in the library. . . .  Porter O revealed employees are expected to wear a mask the entire time they are in the facility; masks are used to protect himself and others.  Porter O also revealed a risk of spreading Covid 19 if masks are not worn appropriately while in the facility.

An observation on [October 1, 2021] at 2:38 pm revealed AD pushing a cart with snacks inside; AD failed to complete hand hygiene between giving residents snacks. . . .  [AD] revealed the expectation was to complete hand hygiene anytime she comes in contact with a resident or their belongings.

* * * *

An observation on [October 1, 2021] at 2:46 pm revealed Dietary P did not complete hand hygiene before entering a resident room . . . .  Dietary P reported the expectation was to wash her hands constantly.

CMS Ex. 1 at 14-15.

The surveyor interviewed the facility's director of nursing, who said that although there is no facility policy specifically stating that all staff are expected to wear an N95 that covers their nose and mouth at all time, to protect residents and staff, staff are nevertheless aware of this expectation through in-service training.  Id. at 15.

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Petitioner does not dispute that staff members either failed to use appropriate hand hygiene or failed to properly wear an N95 mask.  P. Br. at 3, 6.  Petitioner argues that because these incidents occurred in the cold unit, i.e., not on the Covid-19 warm or quarantine wing, and because all staff members were in-serviced after the incidents, the immediate jeopardy declaration is not warranted.  Id.  Petitioner also does not dispute the statements made by its director of nursing.  As discussed above, unrefuted employee statements may constitute substantial evidence.  See Beatrice State Developmental Ctr., DAB No. 2311 at 17, 18; Omni Manor Nursing Home, DAB No. 1920 at 11.

Petitioner points to no documentation permitting exceptions to source control and hand hygiene requirements when staff are caring for residents who have not yet been exposed to Covid-19.  Staff are not relieved of their obligation to follow Petitioner's infection prevention policy merely because they are not providing direct care to Covid-positive residents.  See CMS Ex. 4 at 3 (advising that health care personnel "should wear a facemask at all times while they are in the facility" and that adherence to standard infection prevention control measures including hand hygiene and correctly using PPE is crucial to preventing transmission of Covid-19); CMS Ex. 22 at 2 (infection prevention and control "practices are intended to apply all patients, not just those with suspected or confirmed SARS-CoV-2 infection"), 6 (health care personnel "should wear well-fitting source control at all times while they are in the healthcare facility, including in breakrooms or other spaces where they might encounter co-workers") (emphasis in original).  To the contrary, the THHSC guidance that Petitioner adopted identified hand hygiene compliance and proper face mask usage as critical control measures for all staff.  CMS Ex. 5 at 35, 38, 44.

Even if there were no current positive Covid-19 cases, everyone in the facility was required to use universal source control to prevent the spread of Covid-19.  CMS Ex. 5 at 67.  A staff member monitoring the dining room, when diners need to lower their masks to take bites of food or sips of a drink, is when the mask is most necessary (along with coughing or sneezing).  Coming in contact with items that will be handled by residents, or coming in direct contact with residents by handing them the items, is also a critical time to ensure proper hand hygiene (along with performing patient care).  The staff members failed to follow source control measures while the surveyor was observing them.  The risk of more than minimal harm is shown through employees failing to conform to the most basic method of Covid-19 prevention.  Given the significant threat of any transmission of Covid-19 in a SNF setting, staff's failure to keep their masks raised over their mouth and nose and to perform hand hygiene between food passes or entering resident rooms constituted a risk for more than minimal harm to residents.

Therefore, I conclude that Petitioner was not in substantial compliance with 42 C.F.R. § 483.80(a)(1) (Tag F880).

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8. Petitioner has not met its burden to show that CMS's declaration of immediate jeopardy for the period of September 30 through October 5, 2021, due to Petitioner's noncompliance with 42 C.F.R. § 483.80(a)(1) (Tag F880), was clearly erroneous.

The state survey agency and CMS determined that Petitioner's noncompliance amounted to immediate jeopardy from September 30 through October 5, 2021.  There is no dispute that the state survey agency found that immediate jeopardy was abated on October 6, 2021, and CMS agreed with that determination.  As discussed above, I have determined that Petitioner was not in substantial compliance with Medicare participation requirements for infection prevention and control.  Petitioner now bears the heavy burden to show that the determination that Petitioner's noncompliance under 42 C.F.R. § 483.80(a)(1) posed immediate jeopardy from September 30 through October 5, 2021, was clearly erroneous.

Immediate jeopardy is "a situation in which the provider's noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident."  42 C.F.R. §§ 488.301, 489.3 (emphasis added).  In the context of survey, certification, and enforcement related to SNFs and NFs, a conclusion by the state survey agency and CMS that noncompliance with program participation requirements poses immediate jeopardy to the facility residents triggers specific regulatory provisions that require enhanced enforcement remedies, including authority for CMS to impose a larger CMP than may be imposed when there is no declaration of immediate jeopardy.  42 C.F.R. §§ 488.408(e), 488.438(a)(1)(i), (c), (d).  The regulations also require termination of the facility's provider agreement on an expedited basis or the removal of the immediate jeopardy through appointment of temporary management.  42 C.F.R. §§ 488.410, 488.440(g), 488.456, 489.53(d)(2)(ii).

CMS's finding that deficiencies pose immediate jeopardy to the health or safety of a facility's residents is not an initial determination that triggers a right to request a hearing by an ALJ or that is subject to review.  42 C.F.R. § 498.3(d)(10).  A noncompliance finding resulting in the imposition of an enforcement remedy, except the remedy of monitoring by the state, triggers a right to request a hearing and is subject to review.  42 C.F.R. §§ 488.408(g), 498.3(b)(8), (13).  Furthermore, the level of noncompliance, i.e., scope and severity, is subject to review only if a successful challenge would:  1) affect the amount of CMP that may be imposed, i.e., the higher range of CMP authorized for immediate jeopardy; or 2) affect a finding of substandard quality of care that rendered the facility ineligible to conduct a NATCEP.  42 C.F.R. § 498.3(b)(14), (16).

The determination of immediate jeopardy must be upheld unless Petitioner shows it was clearly erroneous.  42 C.F.R. § 498.60(c)(2).

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CMS's determination of immediate jeopardy is presumed to be correct, and Petitioner has a heavy burden to demonstrate clear error in that determination.  Yakima Valley Sch., DAB No. 2422 at 8-9 (2011); Cal Turner Extended Care Pavilion, DAB No. 2384 at 14-15 (2011); Brian Ctr. Health & Rehab./Goldsboro, DAB No. 2336 at 9 (2010) (citing Barbourville Nursing Home, DAB No. 1962 at 11 (2005), aff'd, Barbourville Nursing Home v. U.S. Dep't of Health & Hum. Servs., 174 F. App'x 932 (6th Cir. 2006)); Maysville Nursing & Rehab. Facility, DAB No. 2317 at 11 (2010); Liberty Commons Nursing & Rehab Ctr. – Johnston, DAB No. 2031 at 18-19 (2006), aff'd, Liberty Commons Nursing & Rehab. Ctr. – Johnson v. Leavitt, 241 F. App'x 76 (4th Cir. 2007).

Once CMS presents evidence supporting a finding of noncompliance, CMS does not need to offer evidence to support its determination that the noncompliance constitutes immediate jeopardy.  Rather, the burden is on the facility to show that the determination is clearly erroneous.  Cal Turner, DAB No. 2384 at 14-15; Liberty Commons Nursing & Rehab. Ctr. – Johnston, 241 F. App'x at 81.  Under the "clearly erroneous" standard, a finding is clearly erroneous even though there may be some evidence to support it if, based on all the evidence, the reviewing judge or authority has a definite and firm conviction that an error has been committed.  United States v. U.S. Gypsum Co., 333 U.S. 364, 394-95 (1948); Dickinson v. Zurko, 527 U.S. 150, 162 (1999); Concrete Pipe & Prods. of Cal., Inc. v. Constr. Laborers Pension Tr. for S. Cal., 508 U.S. 602, 622 (1993).

A finding of immediate jeopardy does not require a finding of actual harm, only a likelihood of serious harm.  Dumas Nursing & Rehab., L.P., DAB No. 2347 at 19 (2010) (citing Life Care Ctr. of Tullahoma, DAB No. 2304 at 58 (2010), aff'd, Life Care Ctr. of Tullahoma v. Sec'y of U.S. Dep't of Health & Hum. Servs., 453 F. App'x 610 (6th Cir. 2011)).  The definition of immediate jeopardy at 42 C.F.R. § 488.301 does not define "likelihood" or establish any temporal parameters for potential harm.  Agape Rehab. of Rock Hill, DAB No. 2411 at 18-19 (2011).  The duration of the period of immediate jeopardy is also subject to the clearly erroneous standard.  Brian Ctr. Health, DAB No. 2336 at 7-8.  There is a difference between "likelihood" as required by the definition of immediate jeopardy and a mere potential.  Likelihood suggests a greater degree of probability that an event will occur than suggested by such terms as a mere possibly or a potential.  Daughters of Miriam Ctr., DAB No. 2067 at 10 (2007).  Jeopardy generally means danger, hazard, or peril.  The focus of the immediate jeopardy determination is how imminent the danger appears and how serious the potential consequences are.  Woodstock Care Ctr., DAB No. 1726 at 39.

Petitioner argues that the imposition of immediate jeopardy was not assessed in compliance with 42 C.F.R. § 498.60(c) and that the cited deficiencies do not warrant an immediate jeopardy-level determination.  See generally P. Br.  However, Petitioner has failed to meet its burden to show that the declaration of immediate jeopardy was clearly erroneous, including the period of immediate jeopardy.  First, the evidence shows that Petitioner did not monitor R1 and R3 for signs and symptoms of Covid-19, did not screen

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R1 for Covid-19 exposure upon his return from an overnight hospital visit, and did not separate R1 and R3 when R1 tested positive for Covid-19, as required by Petitioner's IPCP.  Second, the evidence shows that Petitioner failed to screen all staff and visitors before permitting their entry to the facility, as required by Petitioner's IPCP.  Finally, the evidence shows that Petitioner's staff failed to properly wear N95s, and then failed to perform appropriate hand hygiene when involved in direct resident interaction, as required by Petitioner's IPCP.  The failure to properly implement its IPCP and follow national infection prevention guidelines put Petitioner's residents at increased risk to contract Covid-19.  Petitioner has presented no evidence and does not dispute that elderly and immunocompromised residents were at risk of serious harm or death secondary to Covid-19 infection, which was very easily transmitted.  See, e.g., P. Br. at 2 ("the infection control policy and care were given in accordance with the guidelines as it is clearly indicated by [the] CDC how easily the virus is transmitted.").  Petitioner also does not dispute the surveyor's direct observations that staff failed to screen EMS personnel entering the facility for a non-emergency transport, that staff failed to properly wear N95s, and that staff failed to perform proper hand hygiene when involved in direct resident interaction.  Petitioner's arguments that it isolated R3, used the Quixi system to screen its visitors and staff, and in-serviced its staff members on hand hygiene and mask wearing but that the violations occurred not on the Covid-19 warm or quarantine wing, do not establish that there was no risk for serious harm or death or that Petitioner's IPCP was effectively implemented to reduce the risk for harm so that there was a risk for no more than minimal harm.  On the contrary, Petitioner's concession that R1 exposed R3 upon returning from the hospital is further evidence of the importance of properly implementing an IPCP and enforcing basic source control measures.

Applying the clearly erroneous standard to the record before me and carefully evaluating Petitioner's evidence and arguments related to the noncompliance based on the violation of 42 C.F.R. § 483.80(a)(1), I have no definite and firm conviction that CMS erred in determining that immediate jeopardy existed and that it existed from September 30 through October 5, 2021.  Therefore, I conclude Petitioner has not met its burden to show that the determination of immediate jeopardy or its duration were clearly erroneous.

9. Petitioner did not dispute any of the regulatory factors used to set the CMPs in this case; therefore, I uphold the CMP amounts of $12,750 per day from September 30 through October 5, 2021, and $450 per day from October 6 through November 3, 2021.

I have concluded that Petitioner violated 42 C.F.R. § 483.80(a)(1)12 and the violation posed a risk for more than minimal harm to Petitioner's residents.  I have also concluded

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that Petitioner has failed to show that the declaration of immediate jeopardy for the period September 30 through October 5, 2021, was clearly erroneous.

If a facility is not in substantial compliance with program participation requirements, CMS has the authority to impose one or more of the enforcement remedies listed in 42 C.F.R. § 488.406, including a CMP.  CMS may impose a per day CMP for the number of days that the facility is not in compliance or a per instance CMP for each instance that a facility is not in substantial compliance.  42 C.F.R. § 488.430(a).  The regulations specify that a CMP that is imposed against a facility on a per day basis will fall into one of two ranges of penalties.  42 C.F.R. §§ 488.408, 488.438.  The upper range of a CMP – $6,808 per day to $22,320 per day – is reserved for deficiencies that pose immediate jeopardy to a facility's residents and, in some circumstances, for repeated deficiencies.  42 C.F.R. § 488.438(a)(1)(i), (d)(2); 45 C.F.R. § 102.3 (Table) (2020).  The lower range of CMPs – $112 per day to $6,695 per day – is reserved for deficiencies that do not pose immediate jeopardy, but either cause actual harm to residents, or cause no actual harm but have the potential for causing more than minimal harm.  42 C.F.R. § 488.438(a)(1)(ii); 45 C.F.R. § 102.3 (Table) (2020).

I am to determine whether the amount of any CMP proposed is within reasonable bounds, considering the purpose of the Act and regulations.  Emerald Oaks, DAB No. 1800 at 10 (2001); CarePlex of Silver Spring, DAB No. 1683 at 14-16 (1999); Capitol Hill Cmty. Rehab. & Specialty Care Ctr., DAB No. 1629 (1997).  My review of the reasonableness of the CMP is de novo and based upon the evidence in the record before me.  I am not bound to defer to the CMS determination of the reasonable amount of the CMP to impose, but my authority is limited by regulation.  If I conclude, as I have in this case, that there is a basis for the imposition of an enforcement remedy and the remedy proposed is a CMP, my authority to review the reasonableness of the CMP is limited by 42 C.F.R. § 488.438(e).  The limitations are that I may:  1) not set the CMP at zero or reduce it to zero; 2) not review the exercise of discretion by CMS in selecting to impose a CMP; and 3) only consider the factors specified by 42 C.F.R. § 488.438(f) when determining the reasonableness of the CMP amount.

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In determining whether the amount of a CMP is reasonable, CMS must consider the following factors:  1) the facility's history of noncompliance, including repeated deficiencies; 2) the facility's financial condition; 3) the seriousness of the deficiencies as set forth at 42 C.F.R. § 488.404(b), the same factors CMS and/or the state were to consider when setting the CMP amount; and 4) the facility's degree of culpability, including but not limited to the facility's neglect, indifference, or disregard for resident care, comfort, and safety.  42 C.F.R. § 488.438(f).  The factors that CMS and/or the state were required to consider when setting the CMP amount and that I am required to consider when assessing the reasonableness of the amount are:  1) whether the deficiencies caused no actual harm but had the potential for minimal harm, no actual harm with the potential for more than minimal harm, but not immediate jeopardy, actual harm that is not immediate jeopardy, or immediate jeopardy to resident health and safety; and 2) whether the deficiencies are isolated, constitute a pattern, or are widespread.  42 C.F.R. § 488.404(b).

The DAB has held that ALJs and appellate panels of the DAB "properly presume[] that CMS considered the regulatory factors and that those factors support the amount imposed."  Pinecrest Nursing & Rehab. Ctr., DAB No. 2446 at 23 (2012) (emphasis omitted).  The burden is on Petitioner "‘to demonstrate, through argument and the submission of evidence addressing the regulatory factors, that a reduction is necessary to make the CMP amount reasonable.'"  Id. (quoting Oaks of Mid City Nursing & Rehab. Ctr., DAB No. 2375 at 26-27 (2011)).  Further, unless a facility presents evidence and argument that a particular regulatory factor does not support the CMP amount, an ALJ must sustain it.  Coquina Ctr., DAB No. 1860 at 32 (2002) (emphasis added).

Other than arguing that the scope and severity should be reduced, Petitioner did not contest the CMP amounts imposed by CMS.  Petitioner did not explain why the CMP amounts were not reasonable based on the regulatory factors for determining the amount of CMPs.  Instead, Petitioner attempted to file P. Ex. 21 in support of its argument that CMS imposed an "unusually aggressive" and unreasonable scope and severity deficiency for the period of September 30 through October 6, 2021.  See P. Br. at 8-9; P. Resp. to CMS Objs. at 1-2.

As explained above, I have upheld the alleged deficiencies in this case and do not find that CMS's determination of immediate jeopardy was clearly erroneous.  Therefore, I reject Petitioner's argument that I should reverse the CMPs that CMS imposed.  Because Petitioner did not dispute any of the regulatory factors related to the amount of the CMPs in this case, I uphold the CMP amounts imposed by CMS:  $12,750 per day for immediate jeopardy during the period of September 30 through October 5, 2021, and $450 per day for noncompliance that does not pose immediate jeopardy during the period of October 6 through November 3, 2021.

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VI.  Conclusion

I conclude that Petitioner was not in substantial compliance with Medicare participation requirements.  I conclude that CMS's determination that Petitioner's noncompliance with 42 C.F.R. § 483.80(a)(1) (Tag F880) immediately jeopardized the health and safety of Petitioner's residents was not clearly erroneous.  Finally, I conclude that a CMP of $12,750 per day for the 6-day period of immediate jeopardy noncompliance from September 30 through October 5, 2021, and a CMP of $450 per day for the 29-day period of noncompliance from October 6 through November 3, 2021 are appropriate under the applicable statutory and regulatory factors.