Villa Rancho Bernardo Care Center, DAB CR6568 (2024)

DECISION

The survey in this case violated requirements of section 1819(g) of the Social Security Act (Act) (42 U.S.C. § 1395i-3(g)).  Because the survey was conducted in violation of the Act, the noncompliance cited by the survey is not a basis for the imposition of any enforcement remedy.

But, if on appeal the statutory violation is overlooked or excused, I conclude that Petitioner violated 42 C.F.R. § 483.80, the violation posed a risk for more than minimal harm, and Petitioner has not met its burden to show that the declaration of immediate jeopardy was clearly erroneous.1  If findings of noncompliance are upheld on further review, a CMP of $11,175 for February 18 and 19, 2021, and $435 per day from February 20 through March 29, 2021, a total CMP of $38,880, is a not a reasonable enforcement remedy.  A reasonable enforcement remedy is $6,808 per day for February 18 and 19, 2021, and $217.50 per day from February 20 through March 29, 2021 (38 days), for a total CMP of $ 21,881.

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I.    Background

Petitioner is a skilled nursing facility (SNF) located in Pasadena, California participating in the federal Medicare program.  Healthcare Management Solutions, LLC2 conducted a COVID-193 focused infection control survey at Petitioner’s facility from February 18 through 20, 2021.  Surveyor Kristen Paulsen-Aquirre (the Surveyor), a Healthcare Management Solutions, LLC employee, made findings and conclusions alleging that Petitioner was not in substantial compliance with Medicare participation requirements based on two regulatory violations that posed a risk for more than minimal harm to Petitioner’s residents and posed immediate jeopardy to Petitioner’s residents.  Departmental Appeals Board Electronic Filing System (DAB E-File), Docket Number C-21-671 # 1_a;4 Joint Stipulation of Undisputed Facts (Jt. Stip.) ¶¶ 1-6; CMS Ex. 2.

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On March 16, 2021, CMS notified Petitioner of its initial determination5 that Petitioner was not in substantial compliance with 42 C.F.R. § 483.80 (Tag F8806 Infection Control), and 42 C.F.R. § 483.80(h) (Tag F886 COVID-19 Testing-Residents and Staff).  CMS advised Petitioner that its provider agreement would be terminated on August 20, 2021, and a denial of payments for new admissions (DPNA) would be imposed effective March 31, 2021, if Petitioner did not return to substantial compliance before those dates.  CMS also advised Petitioner that it was imposing a per-day civil money penalty (CMP) of $11,175.00 for February 18 and 19, 2021, and $435 per day from February 20, 2021, until Petitioner returned to substantial compliance, or its provider agreement was terminated on August 20, 2021.  Petitioner was also informed that it was no longer eligible to conduct a nurse aide training and competency evaluation program (NATCEP).7  DAB E-File # 1_a; Jt. Stip. at 2 ¶ 6.

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Petitioner requested a hearing (RFH) before an administrative law judge (ALJ) on April 15, 2021.  The case was assigned to me for hearing and decision and, on April 16, 2021, an Acknowledgment Letter and Standing Order were issued at my direction.

On August 3, 2021, CMS notified Petitioner that the state agency found Petitioner returned to substantial compliance effective April 15, 2021.  CMS advised Petitioner that the termination remedy was rescinded and the DPNA was in effect from March 31 through April 14, 2021.  CMS also advised Petitioner that the total CMP imposed was $45,840.  CMS Ex. 12 at 1-2.  But CMS issued a reopened and revised initial determination by letter dated October 12, 2021.8  CMS advised that it determined that Petitioner returned to substantial compliance on March 30, 2021, and the DPNA never went into effect.  The CMP imposed was $11,175 for February 18 and 19, 2021, and $435 per day from February 20 through March 29, 2021, for a total CMP of $38,880.  CMS Ex. 14 at 1.

On August 13, 2021, CMS filed CMS Exs. 1 through 13.  On September 14, 2021, Petitioner filed Petitioner’s exhibits (P. Exs.) 1 through 23.  On October 11, 2021, Petitioner filed P. Ex. 24.  CMS filed CMS Ex. 14 on October 14, 2021.  Neither party objected to the offered exhibits.  CMS Exs. 1 through 14 and P. Exs. 1 through 24 are admitted as evidence.

On May 3, 2022, the parties jointly moved to waive oral hearing and requested a decision based on the written record.  On May 4, 2022, I accepted the waiver of oral hearing.  On June 3, 2022, the parties filed opening briefs (CMS Br. and P. Br., respectively).  The parties filed reply briefs on July 5, 2022 (CMS Reply and P. Reply, respectively).  CMS filed with its July 5, 2023 reply brief a document (DAB E-File # 25_a) titled “CASPER Report 0003D Provider History Profile” that includes information regarding prior surveys of Petitioner in 2016, 2017, 2018, and 2019.  CMS discusses Petitioner’s compliance history in arguing that the CMP imposed against Petitioner was reasonable.  CMS cites to a CMS website in its discussion and does not specifically refer to the CASPER report.  CMS’s arguments suggest that both the CMS website and the CASPER report were intended to be considered as rebuttal evidence in response to arguments of Petitioner.  CMS Reply at 13-14.  But CMS failed to properly request that I take judicial notice of the CMS website and failed to properly mark and offer the CASPER report as evidence.  Neither the CASPER report nor the CMS website is accepted or considered as rebuttal evidence.

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On April 6, 2023, I ordered the parties to submit additional briefing to address whether the survey was conducted in violation of the authority and responsibility to conduct surveys delegated to the Secretary (the Secretary) of the U.S. Department of Health and Human Services (HHS) and the states by section 1819(g) of the Social Security Act.  The parties filed supplemental briefs (CMS Supp. Br. and P. Supp. Br., respectively).  On June 22, 2023, CMS waived further reply to Petitioner’s supplemental brief.

II.    Discussion

1. Applicable Law9
   1. Statutory and Regulatory Medicare Program Enforcement

The statutory and regulatory requirements for participation of a SNF in Medicare are at section 1819 of the Social Security Act (Act)10 and 42 C.F.R. pt. 483.  Section 1819(h)(2) of the Act authorizes the Secretary to impose enforcement remedies against a SNF for failing to comply substantially with the federal participation requirements established by sections 1819(b), (c), and (d) of the Act and 42 C.F.R. pt. 483.

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 after the date the facility is found to be noncompliant.  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

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participation requirements within three months of the date the facility is found to be noncompliant – commonly referred to as the mandatory or statutory DPNA.  Act § 1819(h)(2)(D).  The Act grants the Secretary discretionary authority to terminate noncompliant SNFs’ 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 other remedies such as 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 long-term care facility that is not complying substantially with federal participation requirements.  “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 (emphasis in original).  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.  Noncompliance refers to any deficiency (statutory or regulatory violation) that causes a facility to be not in substantial compliance, i.e., a deficiency that poses a risk for more than minimal harm.  42 C.F.R. § 488.301.  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.  42 C.F.R. §§ 488.400 (Act authorized Secretary to impose enforcement remedies when facility is not in substantial compliance); 488.402(b) (enforcement remedies are applied based on noncompliance); 488.408(g)(1) and 498.3(b)(13) (facility may only request review of a certification of noncompliance for which an enforcement remedy is imposed). 

The regulations specify the enforcement remedies that CMS may impose if a facility is not in substantial compliance with Medicare requirements.  42 C.F.R. § 488.406.  Generally, CMS is authorized to impose a CMP against a facility not in substantial compliance with a program participation requirement.  The regulations specify that a per-day CMP imposed against a facility 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 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).  “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 (emphasis in original).  The lower range of a CMP, $112 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.  CMS is also authorized to impose a per-instance CMP in the range of $2,233 to $22,320.  42 C.F.R. § 488.438(a)(1)(ii), (2); 45 C.F.R. § 102.3 (Table) (2020).

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2. Limited Right to Review of a Determination to Impose an Enforcement Remedy

The Act and regulations give long-term care facilities against which CMS has imposed an enforcement remedy the right to a hearing before an ALJ.  Act §§ 1128A(c)(2), 1866(h); 42 C.F.R. §§ 488.408(g), 498.3(b)(13).  A facility has a right to appeal a “certification of noncompliance leading to an enforcement remedy.”  42 C.F.R. §§ 488.408(g)(1), 488.330(e), 498.3(b)(13).  However, the choice of remedies, or the factors CMS considered when choosing remedies, are not subject to review.  42 C.F.R. § 488.408(g)(2).  A facility may only challenge the scope and severity level of noncompliance determined by CMS if a successful challenge would affect the range of the CMP that may be imposed or impact the facility’s authority to conduct a NATCEP.  42 C.F.R. § 498.3(b)(14), (d)(10)(i).  The CMS determination as to the level of noncompliance, including the finding of immediate jeopardy, “must be upheld 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 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 in the situation where that finding was the basis for an immediate jeopardy determination.  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).

3. Burden of Proof, Burden of Production, and Quantum of Evidence

The hearing before an ALJ is a de novo proceeding, that is, “a fresh look by a neutral decision-maker at the legal and factual basis for the deficiency findings underlying the remedies.”  Life Care Ctr. of Bardstown, DAB No. 2479 at 33 (2012) (citation omitted).

The allocation of the burden of proof and the quantum of evidence required to meet the burden is not addressed by regulations applicable in this case.11  Rather, the Board has

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long held that the petitioner, i.e., the nongovernmental party, bears the ultimate burden of persuasion to show by a preponderance of the evidence that it was in substantial compliance with participation requirements or any affirmative defense.  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); Cross Creek Health Care Ctr., DAB No. 1665 (1998); Hillman Rehab. Ctr., DAB No. 1611 (1997) (remand to ALJ), DAB No. 1663 (1998) (after remand), aff’d, Hillman Rehab. Ctr. v. United States, No. 98-3789 (GEB), 1999 WL 34813783 (D.N.J. May 13, 1999).

The Board has indicated that CMS has the initial burden of production to make a prima facie showing of noncompliance.  If CMS makes a prima facie showing, then the facility bears the burden to show, by a preponderance of the evidence on the record as a whole, that it was in substantial compliance or had an affirmative defense.  Evergreene Nursing Care Ctr., DAB No. 2069 at 7 (2007).  The Board has not clearly defined the quantum of evidence CMS needs to present to meet its burden of making a prima facie showing.  The Board has stated that CMS must come forward with “evidence related to disputed findings that is sufficient (together with any undisputed findings and relevant legal authority) to establish a prima facie case of noncompliance with a regulatory requirement.”  Id.; Batavia Nursing & Convalescent Ctr., DAB No. 1904.  “Prima facie” means generally that the evidence is “[s]ufficient to establish a fact or raise a presumption unless disproved or rebutted.”  Black’s Law Dictionary 1228 (8th ed. 2004).  One might conclude that if a preponderance of the evidence is required in these proceedings, that standard would also apply to the requirement for CMS to make a prima facie showing; i.e., CMS must present evidence sufficient to establish a fact as more likely true and to raise a presumption, subject to being disproved or rebutted.  However, the Board has never specifically ruled that CMS must support its prima facie case by preponderant evidence, or what happens if it has not, including whether the burden shifts to Petitioner or not.  It is unclear from prior Board decisions whether CMS can make a prima facie showing with little more than mere allegations or a scintilla of evidence.

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I conclude that if in this case the violation of the Act and regulations is overlooked or excused and review proceeds, CMS made a prima facie showing that Petitioner violated 42 C.F.R. § 483.80 and the violation posed a risk for more than minimal harm and immediate jeopardy as alleged under Tag F880 in the Statement of Deficiencies (SOD).  CMS Ex. 2 at 3.  Petitioner has not rebutted the CMS prima facie showing of noncompliance or met its heavy burden to show that the declaration of immediate jeopardy was clearly erroneous.  However, I conclude that there was no violation of 42 C.F.R. § 483.80(h) as alleged under Tag F886.  CMS Ex. 2 at 20.

Petitioner challenges the Board’s allocation of the burdens in its request for hearing.  DAB E-File # 1 at 2-3.  Petitioner argues that the Board’s policy (interpretive rule) imposing the burden on Petitioner to show substantial compliance with program participation requirements and permitting CMS to impose CMPs without establishing it considered each of the regulatory factors deprives it of due process of law or sufficient notice and opportunity to respond.  DAB E-File # 1 at 3.  Petitioner has a right to the procedural due process provided by sections 1128A(c)(2) and 1866(h) of the Act and 42 C.F.R. pt. 498, including, for example, the right to a hearing, representation, to call witnesses and present documentary evidence, to confront and cross-examine witnesses, and to submit argument.  Petitioner does not explain how the Board’s allocation of the burden of persuasion deprives it of any of the provided due process rights or how there is any violation of Petitioner’s substantive due process.  The Board has consistently addressed its allocation of the burden of proof, which has been upheld by the federal courts.  See e.g., Batavia Nursing & Convalescent Ctr., DAB No. 1904 at 15, aff’d, Batavia Nursing & Convalescent Ctr., 129 Fed. App’x 181 (6th Cir. 2005).  I conclude that the Board’s rationale is persuasive and is appropriately applied in this case.  I find no need to restate the Board’s detailed analysis for its interpretive rule allocating the burden of persuasion in cases such as this.  No evidence or argument is disregarded, though the persuasiveness of the arguments and the credibility and the weight of the evidence are judged.  Furthermore, Petitioner ultimately has the right to seek review of this decision and any subsequent Board decision by the appropriate United States Circuit Court of Appeals, which can pass upon the thoroughness of my decision and any decision of the Board.  I conclude that Petitioner suffers in this case no deprivation of its due process rights or prejudice in the delivery of due process.

2. Issues

The issues in this case include the following:

Whether the survey in this case was conducted in violation of section 1819(g) of the Act.

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Whether enforcement remedies may be imposed based on the findings and conclusions of a survey conducted in violation of section 1819(g) of the Act. 

Whether Petitioner was in substantial compliance with the Medicare participation requirements established by 42 C.F.R. § 483.80.

Whether there is a basis for the imposition of an enforcement remedy and, if so, what is the reasonable enforcement remedy.

3. Conclusions of Law

My conclusions of law are based on my findings of fact and analysis.  I have carefully considered all the evidence and the arguments of both parties, although not all may be specifically discussed in this decision.  I discuss the credible evidence given the greatest weight in my decision-making.12  I also discuss any evidence that I find is not credible or worthy of weight.  The fact that evidence is not specifically discussed should not be considered sufficient to rebut the presumption that I considered all the evidence and assigned such weight or probative value to the credible evidence that I determined appropriate within my discretion as an ALJ.  There is no requirement for me to discuss the weight given every piece of evidence considered in this case, nor would it be consistent with notions of judicial economy to do so.  Charles H. Koch, Jr., Admin. L. and Prac. § 5:64 (3d ed. 2013).

1. The survey was conducted in violation of Section 1819(g) of the Act.
2. CMS has no authority to impose enforcement remedies based on the findings and conclusions of a survey conducted in violation of the Act.

(a) Findings of Fact

The survey in this case is referred to as a COVID-19 focused infection control survey.  CMS Ex. 2 at 1.

The survey was conducted February 18 through 20, 2021, by Kristen Paulsen-Aguirre, an employee of Healthcare Management Solutions, LLC.  CMS contracted with the company to conduct COVID-19 focused infection control surveys.  CMS Ex. 1 at 1 ¶ 1.

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There is no evidence that the survey was conducted by or with participation of the California state agency or CMS personnel.  CMS Ex. 1.

The Surveyor has a Bachelor of Science in recreation management.  The Surveyor did not have a degree in nursing or a nursing license.  The Surveyor was not a registered nurse.  She had prior work history as a Certified Therapeutic Recreation Specialist.  The Surveyor was trained by CMS to conduct surveys and her work history reflects that she worked for the Colorado Department of Public Health and Environment as a surveyor for approximately six years.  CMS Ex. 1 at 1 ¶ 3; CMS Ex. 11.

There is no evidence that the Surveyor was supervised by a registered nurse when conducting the COVID-19 focused infection control survey of Petitioner from February 18 through 20, 2021.  CMS Exs. 1, 2.

The COVID-19 focused infection control survey conducted in this case was a standard survey within the meaning of section 1819(g)(2)(a) of the Act that focused on infection control.  CMS Ex. 2.

The COVID-19 focused infection control survey conducted in this case was not an investigation of a complaint that Petitioner violated participation requirements.  The survey also did not involve monitoring of efforts by Petitioner to correct prior noncompliance.  The survey was not based on state agency suspicion that Petitioner was noncompliant with participation requirements.  Therefore, the survey in this case was not within the scope of section 1819(g)(4) of the Act.

(b) Analysis

There are two defects in the survey in this case that must be addressed.  First, the survey was not conducted by a state agency or by CMS, the only two entities authorized by Congress to conduct surveys under section 1819 of the Act.  Second, the survey was not conducted by a registered nurse or a team that included a registered nurse as required by Congress.  These two defects prevent the Secretary and CMS from imposing any enforcement remedy based on the noncompliance cited by the survey.

It should be self-evident that an ALJ and the Board are bound to follow the provisions of the Act and the Secretary’s regulations and may not invalidate either a law or regulation on any ground.  Jewish Home of Eastern Pennsylvania, DAB No. 2380 at 9 (2011); 1866ICPayday, DAB No. 2289 at 14 (2009); Sentinel Medical Laboratories, Inc., DAB No. 1762 at 9 (2001), aff’d, Teitelbaum v. Health Care Financing Admin., 32 F. App’x 865 (9th Cir. 2002).  Because I am bound to follow the provisions of the Act and the Secretary’s regulations, I may not uphold the imposition of an enforcement remedy based on a survey conducted in violation of the Act and regulations.  My decision does not find invalid or reflect a refusal to follow the Act or the Secretary’s regulations.  Rather, this

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decision enforces the provisions of the Act and regulations that limit the authority of the Secretary and CMS.

I first discuss the statutory violation resulting from a survey conducted by a contractor and not CMS or the state agency.  I then discuss the statutory and regulatory violations that arose from the survey that was not conducted by a registered nurse or a team with a registered nurse.

Congress Delegated Authority to Survey Skilled Nursing Facilities to the Secretary and State Agencies

A skilled nursing facility is an institution or distinct part of an institution that is primarily engaged in providing skilled nursing and related services or rehabilitation services to its residents; that has a transfer agreement with one or more hospitals; and meets the requirements of section 1819(b), (c), and (d) of the Act.13

In section 1819(b), (c), and (d) of the Act, Congress established the Medicare participation requirements for a skilled nursing facility.

In section 1819(e) of the Act, Congress specified actions required by the states related to skilled nursing facilities.

In section 1819(f) of the Act, Congress specified actions required of the Secretary related to skilled nursing facilities.  Congress specified that “[i]t is the duty and responsibility of the Secretary to assure that the requirements” of sections 1819(b), (c), and (d) of the Act are adequate and enforced “to protect the health, safety, welfare, and rights of residents and to promote the effective and efficient use of public moneys.”  Act § 1819(f)(1).

In section 1819(g) of the Act, Congress established the process for survey and certification of skilled nursing homes and specified state and federal responsibilities related to survey and certification of skilled nursing homes.  Survey and certification are also controlled by section 1864 of the Act.  In section 1864 of the Act Congress specified

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that the Secretary “shall” make an agreement with states that are willing and able to have state health services or another appropriate state agency survey for the Secretary to make a determination whether an entity meets Medicare participation requirements as a hospital, skilled nursing facility, home health agency, hospice program, rural health clinic, critical access hospital, comprehensive outpatient rehabilitation facility, laboratory, and other entity seeking to participate or participating in Medicare.14  Act § 1864(a) (42 U.S.C. § 1395aa(a)).  Congress “authorized” the Secretary to enter into agreements with states to conduct surveys on a “selective sample basis” or when the Secretary deems appropriate because of “substantial allegations of the existence of a significant deficiency or deficiencies” that could “adversely affect the health and safety of patients” of entities that have been accredited under section 1865 of the Act.  Act § 1864(c).  Under section 1865 of the Act, Congress authorized the Secretary to rely upon the determination of a national accreditation body that an entity meets Medicare participation requirements.  Act § 1865.  Section 1865 of the Act establishes the only exception to the Congressional requirement for the Secretary to use the states to conduct surveys of entities seeking to participate or participating in Medicare as a provider.

Returning to section 1819(g)(1) of the Act, Congress provided that:

Pursuant to an agreement under section 1864 [of the Act], each State shall be responsible for certifying, in accordance with surveys conducted under paragraph (2), the compliance of skilled nursing facilities (other than facilities of the State) with the requirements of subsections (b), (c), and (d).  The Secretary shall be responsible for certifying, in accordance with surveys conducted under paragraph (2), the compliance of State skilled nursing facilities with the requirements of such subsections.

Section 1819(g)(2) of the Act is discussed in more detail later in this decision in the context of the lack of qualification of the surveyor in this case as a registered nurse. 

Section 1819(g)(3) of the Act, requires that the Secretary conduct onsite surveys of a sample of the skilled nursing facilities surveyed by the state under section 1819(g)(2) of the Act.  The Secretary is authorized to take remedial action against a state for inadequate survey performance.  Act § 1819(g)(3)(C).  Section 1819(g)(3)(D) of the Act authorizes

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the Secretary to conduct a survey of any skilled nursing facility he suspects may not meet the requirements of subsections 1819 (b), (c), and (d) of the Act and make independent and binding determinations regarding compliance.

I conclude that, aside from the provisions for accreditation by national accrediting organizations, Congress did not authorize in the Act the use of private contractors by CMS or the state to conduct surveys to determine compliance or noncompliance.  The regulations are not inconsistent with the Act and do not purport to grant authority to use private contractors to conduct surveys rather than a state agency or CMS.

Congress required in section 1871 of the Act that the Secretary promulgate regulations necessary to administer Medicare.  Azar v. Allina Health Services, 587 U.S. 566 (2019).  The Secretary issued regulations controlling survey and certification in 42 C.F.R. pt. 488. 

In 42 C.F.R. § 488.1, “state survey agency” is defined as the state health agency or other appropriate state or local agency CMS uses to perform survey and review function as provided in sections 1864, 1819(g), and 1919(g) of the Act.  The use of national accrediting organizations as authorized by section 1865 of the Act is covered by 42 C.F.R. §§ 488.4-488.9.  The requirement for the Secretary to enter agreements with states to use state or local agencies to conduct surveys to determine Medicare compliance and to validate accreditation by an accrediting organization is recognized by 42 C.F.R. §§ 488.10(a) and (c), and 488.11.  Under 42 C.F.R. § 488.12, the state agency makes a certification of its survey findings to CMS, based on which CMS then determines whether a provider or supplier is eligible to participate in or be covered by Medicare.  Under 42 C.F.R. §§ 488.20 and 488.24, state agencies conduct the periodic surveys and certifications of compliance or noncompliance.  Specific principles that state agencies must satisfy when conducting surveys are established by 42 C.F.R. § 488.26(c). 

Specific regulatory requirements for survey and certification of long-term care facilities, i.e., skilled nursing facilities under section 1819 of the Act and nursing facilities under section 1919 of the Act, were promulgated by the Secretary in 42 C.F.R. pt. 488 subpt. E.  Under 42 C.F.R. § 488.305(a), the state survey agency “must conduct standard surveys”15 for each SNF and NF.  The frequency of standard surveys is specified by 42 C.F.R. § 488.308.  The state survey agency also conducts other surveys such as abbreviated standard surveys (42 C.F.R. § 488.308(c) and (e)) and extended surveys (42 C.F.R. § 488.310).  The state survey agency also conducts surveys for the investigation of complaints under 42 C.F.R. §§ 488.308(f) and 488.332.  Pursuant to 42 C.F.R. § 488.312,

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CMS and the state survey agency are required to implement programs to measure accuracy and improve consistency in the survey process and the imposition of enforcement remedies.  The Secretary adopted sanctions that may be imposed on a state survey agency for inadequate survey performance.  42 C.F.R. § 488.320.

The Secretary provided in 42 C.F.R. § 488.330(a)(1)(i), that state survey agencies “survey all facilities for compliance or noncompliance with requirements for long term care facilities.”  42 C.F.R. § 488.330(a)(1)(i).  A federal validation survey may follow a state agency survey.  Certification of compliance or noncompliance is based on state survey agency findings or CMS survey findings for state-operated facilities.  42 C.F.R. § 488.330(a)(2).  A certification of noncompliance requires enforcement action.  42 C.F.R. § 488.330(b)(2).

Aside from the provisions for accreditation by national accrediting organizations, the regulations do not authorize the use of private contractors by CMS or the state to conduct surveys to determine compliance or noncompliance.

The Secretary was empowered by Congress to administer Medicare.  But the Secretary was not delegated unlimited power to do so.  Rather, Congress imposed specific obligations and requirements upon the Secretary as part of the limited delegation of authority.  The limitations and obligations, i.e., the limitations on delegation, are specified in the Act, and the Secretary’s delegation to CMS by regulation reflects the same statutory limitations.  Based on findings of surveys conducted by CMS or a state survey agency, the Secretary is required by Congress, to impose enforcement remedies upon a SNF or NF that is not in compliance with Medicare participation requirements based on the recommendation of a state survey agency.  Act § 1819(h)(2).  States have the authority to impose enforcement remedies pursuant to section 1919 of the Act.  The Secretary has delegated his authority to impose enforcement remedies to CMS.  42 C.F.R. pt. 488, subpt. F.  No provisions of the Act or regulations authorize the imposition of enforcement remedies based on the recommendation of a private contractor, not even a national accrediting body.

Government contracting by executive branch agencies is subject to the Federal Acquisition Regulations.  48 C.F.R. § 1.101 (FAR § 1.101).  The FAR is instructive in this situation to illustrate the error of using the private contractor Healthcare Management Solutions, LLC and its employee to conduct a survey of a long-term care facility, an inherently governmental function.16  FAR § 7.503(a) (48 C.F.R. § 7.503(a)) prohibits the

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use of a contract for the performance of inherently governmental functions.  A lengthy list of examples of functions considered to be inherently governmental is set forth in FAR § 7.503(c).  FAR § 7.503(c)(15) lists the approval of federal licensing actions and inspections as an example of an inherently governmental function.  It may be argued that enrollment in Medicare and entering a provider agreement with the Secretary is not a license and surveys are not inspections.  However, the Act and regulations are clear that an entity must enroll in Medicare subject to approval of the Secretary and, based on that enrollment, the entity is permitted to participate in Medicare subject to surveys to determine compliance.  The similarity to licensing and inspections is readily apparent, at least to the extent it is possible to recognize the existence of an inherently governmental function for which no executive branch agency should award a contract.  FAR § 7.503(c)(17) lists as an example of an inherently governmental function the disbursement of public funds.  FAR § 7.503(c)(18) lists control of treasury accounts as an example of an inherently governmental function.  FAR § 7.503(c)(19) lists the administration of public trusts as an example of inherently governmental functions.  Title XVIII of the Act grants the Secretary authority to control access to the Medicare trust funds,17 which is accomplished in part by the survey and certification of skilled nursing facilities – further illustrating that survey and certification should be considered an inherently governmental function. 

I conclude that the CMS use of a contractor to conduct a survey under section 1819(g) of the Act exceeded the Congressional delegation of authority to the Secretary under the statute.  As discussed later, the survey cannot be a basis for the imposition of enforcement remedies because the Secretary’s and CMS’s authority to impose enforcement remedies is limited to surveys conducted within the Secretary’s delegated authority under section 1819(g) of the Act. 

The Focused Infection Control Survey Was an Infection Control Survey for which a Registered Nurse is Required Under Section 1819(g)(2) of the Act

The survey in this case is also tainted by the fact that it was an infection control survey conducted by an individual who was not a registered nurse and without a team that included a registered nurse.  I conclude that the Act and regulations require that that an infection control survey involve a registered nurse.  I further conclude that the use of a private contractor and its employee to conduct a survey of a long-term care facility violated the delegation of authority to the Secretary to impose enforcement remedies based on surveys conducted in accordance with section 1819 of the Act. 

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Section 1819(g) of the Act, titled “Survey and Certification Process,” includes subsection 1819(g)(1) titled “State and Federal Responsibility.”  The subsection provides that a state acting pursuant to an agreement with the Secretary under section 1864 of the Act, is responsible to certify compliance with Medicare participation requirements of section 1819(b), (c), and (d) of the Act of a skilled nursing home based on surveys conducted pursuant to section 1819(g)(2) of the Act. 

Section 1819(g)(2) of the Act describes standard and extended surveys.18  Infection control is one of the specific areas to be considered a standard survey.  Act § 1819(g)(2)(A)(ii)(I). 

Section 1819(g)(2)(E)(i) of the Act provides that surveys “shall be conducted by a multidisciplinary team of professionals (including a registered professional nurse).” 

Section 1819(g)(4) of the Act titled “Investigation of Complaints and Monitoring Compliance,” has created some confusion.  The Act requires that each state have procedures and staff to conduct the investigations of complaints about a SNF’s compliance with Medicare participation requirements.  The state is also required to “monitor, on-site, on a regular, as needed basis, a skilled nursing facility’s compliance with Medicare participation requirements when the facility was found not in compliance and is in process of correcting the noncompliance; the facility has returned to compliance, but verification of continued compliance is deemed necessary; or the state has reason to question a facility’s compliance.  Act § 1819(g)(4).  Section 1819(g)(4) of the Act provides that, for the investigation of complaints and monitoring compliance, the state may use “a specialized team (including an attorney, an auditor, and appropriate health care professionals)” to do such investigations and monitoring.  Unlike section 1819(g)(2), section 1819(g)(4) does not specify that a registered nurse be involved in a complaint investigation or compliance monitoring. 

In 42 C.F.R. § 488.314(a)(1), the Secretary required that the survey team conducting a survey under sections 1819(g)(2) and 1919(g)(2) of the Act must include a registered nurse. 

Provisions for investigation of complaints and monitoring compliance are found in 42 C.F.R. § 488.332.  Complaints are investigated by the state survey agency.  42 C.F.R. § 488.332(a)(1).  The state survey agency is also responsible for conducting on-site

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monitoring.  42 C.F.R. § 488.332(b).  Composition of the investigative team is specified in 42 C.F.R. § 488.332(c).  The provisions of 42 C.F.R. § 488.332 are consistent with section 1819(g)(4) of the Act, and do not require that a registered nurse be involved in a complaint survey or compliance monitoring. 

On August 4, 2017, CMS published a notice of a final rule at 82 Fed. Reg. 36,530.  (Aug. 4, 2017).  CMS acknowledged in the notice that sections 1819(g)(2) and 1919(g)(2) required that a registered nurse be part of a survey team conducting a standard or extended survey.  CMS also recognized that a registered nurse was not necessarily required for a compliant investigation or for monitoring compliance.  By its final rule, CMS amended 42 C.F.R. § 488.314 to distinguish between standard and extended surveys and compliant investigations or compliance monitoring and the requirement for a registered nurse.19  82 Fed. Reg. at 36,624, 36,631.  CMS stated:

We thus believe that regulatory changes are needed to clarify that only surveys conducted under sections 1819(g)(2) and 1919(g)(2) of the Act are subject to the requirement at §488.314 that a survey team consist of an interdisciplinary team that must include a registered nurse.  Complaint surveys and surveys related to on-site monitoring, including revisit surveys, are subject to the requirements of sections 1819(g)(4) and 1919(g)(4) of the Act and §488.332, which allow the state survey agency to use a specialized investigative team that may include appropriate health care professionals but need not include a registered nurse.

82 Fed. Reg. at 36,624.  CMS failed to note that the requirement to use a registered nurse for surveys under section 1819(g)(2) and 1919(g)(2) of the Act is required by Congress by subsections 1819(g)(2)(E) and 1919(g)(2)(E) of the Act.

CMS changed multiple regulations (42 C.F.R. §§ 488.30, 488.301, 488.308, 488.314) to clarify regulatory requirements for survey team composition.  Clarifications included: the definition of complaint survey was modified to state that sections 1819(g)(4) and 1919 (g)(4) of the Act applied to a complaint survey (42 C.F.R. § 488.30); a change was made to clarify that an abbreviated standard survey to investigate a complaint or conduct onsite monitoring for compliance is subject 42 C.F.R. § 488.332 (which does not require a registered nurse to necessarily be part of the survey team); consolidation of provisions

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related to surveys to investigate complaints under a subsection titled “Investigation of Complaints (42 C.F.R. § 488.308); addition of language to 42 C.F.R. § 488.314(a)(1) to specify that a survey team with a registered nurse is only required for a survey conducted under sections 1819(g)(2) and 1919(g)(2) of the Act.  82 Fed. Reg. at 36,635-636.  

The CMS rulemaking makes clear that CMS agrees that if a survey is as described in sections 1819(g)(2) and 1919(g)(2) of the Act, a registered nurse must be part of the survey team.  If a survey is to investigate a complaint or monitor compliance, such as a revisit survey, the survey is subject to section 1819(g)(4) and 1919(g)(4) of the Act and a registered nurse need not necessarily be included among the survey team. 

The pertinent facts are not in dispute in this case.  The Surveyor had a Bachelor of Science in recreation management, not a nursing degree, and she was not a registered nurse.  The Surveyor’s work history was as a Certified Therapeutic Recreation Specialist and a surveyor in Colorado.  There is no question she had CMS-approved training as a surveyor.  CMS Ex. 1 at 1 ¶ 3; CMS Ex. 11.  According to 42 C.F.R. § 488.314(b), the CMS comprehensive training includes:  application and interpretation of the applicable regulations; techniques and survey procedures for standard and extended surveys; and techniques for auditing resident assessments and care plans.  There is no evidence to suggest that the Surveyor had training and knowledge equivalent to that of a registered nurse.  There is no evidence that the Surveyor was supervised by a registered nurse when conducting the COVID-19 focused infection control survey of Petitioner from February 18 through 20, 2021.  CMS Exs. 1, 2. 

I conclude that the COVID-19 focused infection control survey conducted in this case was a standard survey within the meaning of section 1819(g)(2)(a) of the Act that focused on infection control.  CMS Ex. 2 at 1.  The COVID-19 focused infection control survey conducted in this case was not an investigation of a complaint that Petitioner violated participation requirements.  The survey also did not involve monitoring of efforts by Petitioner to correct prior noncompliance, nor was it based on state agency suspicion that Petitioner was noncompliant with participation requirements.  Therefore, the survey in this case was not within the scope of sections 1819(g)(4) and 1919(g)(4) of the Act.  Rather, the survey was an infection control survey.  And Congress specifically listed an infection control survey as among those standard surveys for which a registered nurse was required.  Act §§ 1819(g)(2)(A)(ii)(I), 1919(g)(2)(A)(ii)(I).

I conclude that the survey of Petitioner did not involve a registered nurse in violation of the requirement of sections 1819(g)(2) and 1919(g)(2) of the Act.

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Congress Delegated Authority for Imposition of Enforcement Remedies such as a CMP for Surveys Conducted Under Section 1819(g) of the Act.

No Enforcement Remedy May be Imposed or Approved for a Survey not Conducted in Accordance with Section 1819(g) of the Act. 

Congress authorized the Secretary to take actions against a SNF that is not in compliance with Medicare participation requirements of section 1819(b), (c), and (d) of the Act.  The actions, often referred to as enforcement remedies, are describe in section 1819(h)(2) of the Act.  Section 1819(h)(5) of the Act provides that the remedies authorized by section 1819(h) are in addition to those otherwise available under state or federal law and should not be considered to limit other remedies, including any available to an individual under the common law.

I conclude, based on the plain language of section 1819 of the Act, that the Secretary’s authority to impose the enforcement remedies authorized by Congress under section 1819(h) of the Act is contingent upon the Secretary’s or CMS’s compliance with the requirements of section 1819 of the Act, including the survey requirements of section 1819(g).

Because in this case the survey of Petitioner violated the requirement of section 1819(g)(2) of the Act for a registered nurse, there is no authority for CMS or the Secretary to impose any of the enforcement remedies authorized by Congress in section 1819(h) of the Act.

CMS Response to Specified Issues

On April 6, 2023, I ordered the parties to provide me supplemental briefing discussing the use of a contractor to conduct the survey in this case and the conducting of the survey without a registered nurse.  CMS filed a supplemental brief on May 5, 2023.  Petitioner filed a supplemental brief on June 5, 2023.  CMS waived filing a reply to Petitioner’s supplemental brief.

CMS’s arguments are:

The survey in this case was not subject to section 1819(g)(2) of the Act but, rather 1819(g)(4).

The regulations and prior decisions of the Board establish that inadequate survey performance does not relieve a SNF of program participation requirements or invalidate legitimate and adequately documented noncompliance.

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Review of whether the Secretary, the state, and CMS complied with the requirements of the Act, is beyond the authority of the ALJ.

I conclude that the CMS arguments are erroneous and not persuasive.

CMS argues that, under section 1819(g)(4) of the Act and 42 C.F.R. § 488.332, the state may use a specialized team that does not include a registered nurse for purposes of surveying a substandard nursing home.  CMS overlooks that section 1819(g)(4) and 42 C.F.R. § 488.332 apply only in the case of a survey to investigate a complaint or compliance monitoring – limitations specifically recognized by CMS in the August 4, 2017 rulemaking.  82 Fed. Reg. 36,530.  The statement of deficiencies (CMS Ex. 2) and the Surveyor’s declaration (CMS Ex. 1) do not show that the survey was in response to a complaint of noncompliance or compliance monitoring, such as a revisit survey.  CMS points to no evidence to support a finding that the survey in this case was in response to a complaint or involved compliance monitoring.20  CMS Supp. Br. at 1-2.  I conclude that section 1819(g)(4) and 42 C.F.R. § 488.332 do not apply.  The evidence shows that the survey was conducted to determine whether Petitioner’s infection control satisfied regulatory requirements, specifically COVID-19 related provisions.  I conclude that the survey in this case involving examination of Petitioner’s infection control, even though limited in nature, fell within the description of a standard survey or abbreviated standard survey under section 1819(g)(2)(a) of the Act.  Accordingly, the survey team that conducted the survey of Petitioner had to include a registered nurse pursuant to section 1819(g)(2)(E)(i) of the Act.

The argument that inadequate survey performance by the state survey agency does not relieve a skilled nursing facility of the requirement to comply with Medicare participation

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requirements or adequately documented noncompliance is not incorrect.  But that does not address the issue in this case.  The Secretary’s regulations provide that a state survey agency’s failure to follow the procedures of 42 C.F.R. pt. 488 “will not invalidate otherwise legitimate determinations that a facility’s deficiencies exist.”  42 C.F.R. § 488.305(b).  According to 42 C.F.R. § 488.318(b), inadequate survey performance does not relive a skilled nursing facility or a nursing facility of the obligation to meet program participation requirements or “invalidate adequately documented deficiencies.”  42 C.F.R. § 488.318(b).  The two regulations are not consistent with one referring to “legitimate determinations” that there are deficiencies and the other referring to “adequately documented deficiencies.”  However, the inconsistency need not be resolved.  It is clear from the two regulations that the Secretary did not intend to permit a facility to escape responsibility for noncompliance, simply based on an error in the survey process by the state agency or CMS.

But this case does not involve an error in the survey process.  The problem is that the Secretary and CMS failed to comply with the requirement of section 1819(g)(2) of the Act and 42 C.F.R. § 488.314(a) by not including a registered nurse on the survey team that conducted the survey of Petitioner.  Congress only granted the Secretary the authority to conduct a survey of the type in this case with a registered professional nurse on the survey team.  Therefore, the Secretary and CMS had no authority to conduct the survey in this case without a registered nurse.  Further, Congress granted the Secretary authority in section 1819(h) of the Act to impose enforcement remedies but based on surveys conducted consistent with the requirements of the Act.  Because the survey of Petitioner did not comply with section 1819(g)(2) of the Act, CMS and the Secretary had no authority to impose any enforcement remedy based on the survey findings.  Even if I concluded that the noncompliance alleged by the surveyor is adequately documented, I do not have authority to ignore the requirements of the Act or the Secretary’s regulations and uphold the imposition of enforcement remedies based on a survey conducted in violation of the Act and regulations.  It is surprising that CMS suggests that because it makes an independent determination of noncompliance, the statutory and regulatory violation can be ignored.  If that is true, CMS is not bound by the Act or regulations, which clearly cannot be correct.

The final CMS argument – that an ALJ does not have authority to review whether the Secretary or CMS acted in compliance with the Act and regulations – reflects a serious misconception of the purpose of granting a regulated entity a right to a neutral adjudicator’s review of agency action.  If the CMS position is to be accepted, no relief for a regulated entity is possible as CMS could act with impunity as all actions of CMS would have to be upheld.  Clearly this could not be the intent of Congress.  CMS argues that under 42 C.F.R. pt. 498, ALJ and Board review are limited to review of initial determinations of CMS, specifically those listed in 42 C.F.R. § 498.3(b).  CMS asserts that the “propriety of the survey process is not a reviewable question.”  CMS Supp. Br. at 3.  The CMS position is unreasonable and unsupportable.  ALJs and the Board act with

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delegated authority of the Secretary to review cases for which the Secretary has provided regulated entities a right to a hearing on the record.  As already discussed, ALJs are required to comply with the Act and regulations in providing review to a regulated entity.  If, as CMS, suggests an ALJ or the Board is prevented from reviewing whether CMS acted lawfully, i.e., consistent with the Act and regulations, in conducting a survey and imposing an enforcement remedy, the effect is to preclude the Secretary from correcting an error of law committed by CMS in executing the Act and regulations.  If the CMS position is accepted, then the first review of whether CMS acted lawfully would be by the federal court with jurisdiction and not the Secretary.  Congress entrusted the Secretary with responsibility and authority to administer the insurance programs established by the Act, not CMS.  Act § 1871.  The CMS position that ALJs and the Board, who act with delegated authority of the Secretary, have no authority to review the lawfulness of the conduct of surveys by CMS or the state is at odds with the responsibility and authority granted the Secretary by Congress.

CMS cites the decision of an appellate panel of the Board in Avon Nursing Home, DAB 2830 (2017) in support of its positions.  In that case, Avon, a skilled nursing facility, was found not in substantial compliance with Medicare participation requirements by a survey conducted by a state agency.  Avon requested a hearing.  The ALJ concluded that the survey was invalid because the survey team did not include a registered nurse in violation of section 1819(g)(2)(E)(i) of the Act and there was no lawful basis for imposing an enforcement remedy.  The Board concluded that the state agency’s failure to comply with section 1819(g)(2)(E)(i) of the Act did not invalidate the CMS determination that Avon was noncompliant or the enforcement remedy.  Avon, DAB No. 2830 at 1-2.  The Board acknowledged that surveys are to be conducted by state survey agencies under agreements with the Secretary, and that a registered nurse must be included in surveys covered by section 1819(g)(2) of the Act and 42 C.F.R. § 488.314(a)(1).  Avon, DAB No. 2830 at 3.  Factually, the Board found that the state agency performed a complaint survey that found noncompliance that was followed by a compliance survey.  Avon, DAB No. 2830 at 4.  Based on the clarification of the CMS regulations in its August 7, 2017 rulemaking, it is now clear that the surveys of Avon were subject to section 1819(g)(4) of the Act and 42 C.F.R. § 488.332 under which there is no requirement for a registered nurse to participate in a complaint or compliance survey.  82 Fed. Reg. at 36,624.21  The

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Board concluded it did not need to decide whether a registered nurse was required on the Avon survey team by the Act or regulations.  Avon, DAB No. 2830 at 10.  Rather the Board’s decision upholding the CMS enforcement action is based on the Board’s conclusion that inadequate survey performance is not grounds to overturn CMS findings of noncompliance and the imposition of enforcement remedies based on the noncompliance.  The Board effectively made irrelevant whether the Secretary, CMS, and the state agencies comply with the Act and regulations that authorize surveys and the imposition of enforcement remedies for noncompliance.  According to the Board, even if a survey is conducted in violation of the law, if CMS nevertheless concludes there is noncompliance, the ALJ must conduct a de novo review of the evidence to determine whether there was noncompliance.  Avon, DAB No. 2830 at 9-15.  The Board vacated the ALJ decision in Avon and remanded for further action by the ALJ.  However, there is no further reported history on the case indicating it was resolved by the parties without further action by the ALJ or the Board.  I do not find the Board’s decision in Avon to be persuasive precedent.  It is not a reasonable interpretation of the law to conclude that the Secretary and CMS who act only with authority to administer the Medicare program delegated by Congress can simply ignore the limitations of the delegated authority.  It is also unreasonable to suggest that an ALJ or the Board can simply ignore the law and regulations and the limitations imposed by Congress.

However, if on further review it is determined that Avon is good authority, I have conducted de novo review of the allegations of noncompliance. 

3. If on further appeal it is determined that the statutory and regulatory violations should be overlooked or excused, I conclude CMS made a prima facie showing of a violation of 42 C.F.R. § 483.80 (Tag F880).
4. Petitioner has not rebutted CMS’s prima facie showing of noncompliance under 42 C.F.R. § 483.80 (Tag F880), i.e., a violation of the regulation that posed a risk for more than minimal harm.
5. Petitioner’s violation of 42 C.F.R. § 483.80, which posed a risk for more than minimal harm, is a basis for the imposition of an enforcement remedy.  

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ALLEGED PERIOD OF NONCOMPLIANCE AND THE SUBSTANTIVE LEGAL REQUIREMENTS

The Surveyor alleged in the SOD under Tag F880 that Petitioner violated of 42 C.F.R. § 483.80(a)(1), (2), (4), (e), (f), and (h) and that the violation posed immediate jeopardy. 22  CMS Ex. 2 at 3.  The Surveyor also alleged under Tag F886 that Petitioner violated 42 C.F.R. § 483.80(h)(1)-(6) and that the violation posed immediate jeopardy.  CMS Ex. 2 at 20.

The October 12, 2021 CMS reopened and revised initial determination shows that CMS accepted the Surveyors findings and conclusions.  CMS imposed a CMP of $11,175 per day for two days of immediate jeopardy on February 18 and 19, 2021, and $435 per day for noncompliance that was not immediate jeopardy from February 20 through March 29, 2021.  CMS determined that Petitioner returned to substantial compliance effective March 30, 2021.  CMS Ex. 14 at 1.  Therefore, the period that the alleged noncompliance posed immediate jeopardy was February 18 and 19, 2021, and the full period of alleged noncompliance was February 18 through March 29, 2021.

Pursuant to 42 C.F.R. § 483.80, Petitioner “must establish and maintain an infection prevention and control program designed to provide a safe, sanitary, and comfortable environment and to help prevent the development and transmission of communicable diseases and infections.  Following are the requirements imposed on Petitioner by 42 C.F.R. § 493.80(a)(1)-(2) and (4):

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

(1)  A system for preventing, identifying, reporting, investigating, and controlling infections and communicable diseases for all residents, staff, volunteers, visitors, and other individuals providing services under a contractual arrangement based upon the facility assessment conducted according to [42 C.F.R.] § 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

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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.

42 C.F.R. § 483.80(a)(1)-(2), (4) (emphasis added).23

There is no dispute that Petitioner established the IPCP required by 42 C.F.R. § 483.80.  CMS Ex. 2 at 5; CMS Br. at 6 (CMS does not allege Petitioner had adopted inadequate procedures).  The gist of the Surveyor’s allegation is that Petitioner failed to properly implement its policy to ensure Residents 1 and 2 were kept isolated from other residents and failed to ensure there was adequate social distancing and masking, and, in one instance, staff failed to use personal protective equipment (PPE).  CMS Ex. 2 at 5, 7, 19‑20.  CMS argues that the two essential questions are:  what Petitioner’s IPCP required; and did Petitioner follow its IPCP?  CMS Br. at 6.  The adequacy of Petitioner’s IPCP is not at issue and there is no issue regarding whether Petitioner’s IPCP met “national standards.”  I note that Petitioner has made clear that it follows California

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Department of Public Health (CDPH), Centers for Disease Control and Prevention (CDC), CMS, and Food and Drug Administration (FDA) guidance as evidence of the national standards.  CMS Ex. 8 at 2, 22-24.

I conclude that the issue before me is whether Petitioner implemented its adequate IPCP as required by 42 C.F.R. § 483.80.

Pursuant to 42 C.F.R. § 483.80(h),24 Petitioner:

[M]ust test residents and facility staff, including individuals providing services under arrangement and volunteers, for COVID-19. At a minimum, for all residents and facility staff, including individuals providing services under arrangement and volunteers, the LTC facility must:

(1)  Conduct testing based on parameters set forth by the Secretary, including but not limited to:

(i)  Testing frequency;
(ii)  The identification of any individual specified in this paragraph diagnosed with COVID-19 in the facility;
(iii)  The identification of any individual specified in this paragraph with symptoms consistent with

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COVID‑19 or with known or suspected exposure to COVID‑19;
(iv)  The criteria for conducting testing of asymptomatic individuals specified in this paragraph, such as the positivity rate of COVID-19 in a county;
(v)  The response time for test results; and
(vi)  Other factors specified by the Secretary that help identify and prevent the transmission of COVID-19.

(2)  Conduct testing in a manner that is consistent with current standards of practice for conducting COVID–19 tests;

(3)  For each instance of testing:

(i) Document that testing was completed and the results of each staff test; and
(ii) Document in the resident records that testing was offered, completed (as appropriate to the resident’s testing status), and the results of each test.

(4)  Upon the identification of an individual specified in this paragraph with symptoms consistent with COVID-19, or who tests positive for COVID-19, take actions to prevent the transmission of COVID-19.

(5)  Have procedures for addressing residents and staff, including individuals providing services under arrangement and volunteers, who refuse testing or are unable to be tested.

(6)  When necessary, such as in emergencies due to testing supply shortages, contact state and local health departments to assist in testing efforts, such as obtaining testing supplies or processing test results.

42 C.F.R. § 483.80(h)(1)-(6) (emphasis added).

The Surveyor alleged in the SOD under Tag F886 that Petitioner failed to test residents according to current testing standards from January 29 through February 20, 2021, because Petitioner, in two instances, only tested residents on one unit when a resident on the unit tested positive for COVID-19, rather than testing all residents on all six of Petitioner’s units.  CMS Ex. 2 at 22-23.

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For this allegation of noncompliance, CMS also focuses on Petitioner’s IPCP.  CMS argues before me that Petitioner’s IPCP required that Petitioner test all residents and staff for COVID-19 if there is even a single new case of COVID-19.  CMS Br. at 10-11.  The gist of the CMS argument is that by failing to follow its IPCP, Petitioner failed to test consistent with current standards for COVID-19 testing, a requirement of 42 C.F.R. § 483.80(h)(2). 

It is important to note that 42 C.F.R. § 483.80(a) refers to national standards but does not identify those standards.  Similarly, 42 C.F.R. § 483.80(h) does not identify what are the current standards of practice for conducting COVID-19 tests.  Therefore, the gist of CMS’s arguments are that Petitioner adopted national standards and current standards of practice as set forth in its IPCP, but then failed to following those standards. 

The pertinent facts related to both allegations of noncompliance are mostly undisputed.

1. Findings of Fact Related to Alleged Failure to Implement IPCP in Violation of 42 C.F.R. § 483.80

The noncompliance cited under Tag F880 refers to Residents 1 and 2.

Resident 1

Resident 1 was admitted to Petitioner on February 11, 2021, from Temecula Valley Hospital.25  Resident 1 had been in the hospital since February 1, 2021.  He was 68.  Resident 1 was assigned to room 109 bed A.  CMS Ex. 3 at 1.  On admission to Petitioner, his physician ordered contact and droplet-based isolation precautions indefinitely.  CMS Ex. 3 at 2.

On February 9, 2021, two days before admission to Petitioner, Resident 1 was tested negative for COVID-19.  CMS Ex. 4 at 1.  Resident 1’s care plan at Petitioner dated February 12, 2021, listed as a concern/problem that he was constantly taking off his face mask, refused his face mask, and did not want to use a face mask.  Interventions were to monitor for signs and symptoms of COVID-19, continuing to offer a face mask when the resident was out of the room, education, maintaining social distancing of six feet, and ensuring Resident 1 washed his hands as necessary.  CMS Ex. 4 at 2; P. Ex. 1 at 49.  The care plan also listed that Resident 1 was at risk for COVID-19.  Interventions included encouraging Resident 1 to stay in his room and to cover his face when a staff member was in the room; reminding and assisting Resident 1 to wash his hands; monitoring for signs and symptoms of COVID-19 and reporting to his physician if necessary; visitor

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restrictions and maintaining social distancing of six feet; contact isolation indefinitely; as a new admission, Resident 1 was to be on contact isolation for 14 days, that is until February 25, 2021; staff were to wear a mask; and he was to be encouraged to do individual activities of choice in his room.  CMS Ex. 4 at 3-4.

Petitioner placed in evidence additional records for Resident 1.  The additional records show Resident 1 suffered from dementia with behavior disturbance; he was a wanderer; and he was placed in Petitioner’s secure unit because he was previously found wandering outside in the neighborhood confused.  P. Ex. 1 at 1; P. Ex. 1 at 50.  He was evaluated as not having capacity to make decisions.  P. Ex. 1 at 1.  Progress notes from admission to March 30, 2021, nurse notes from admission to February 14, 2021, and weekly summaries from February 20 through March 28, 2021, do not show that Resident 1 developed COVID-19 or had signs or symptoms of COVID-19.26  P. Ex. 1 at 1-11, 16-35.  At the time of admission, Resident 1 was combative with staff including trying to kick and hit staff.  P. Ex. 1 at 13, 15.  Resident 1 had a care plan dated February 12, 2021, that listed as a concern/problem that the resident was at risk for mood or behavior changes due to COVID-19 restrictions.  Interventions included observation for adverse effects, mood/behavior changes, encouraging to engage in activities in his room, encouraging family and visitors by phone or video teleconference, and education.  P. Ex. 1 at 40.  Resident 1 also had activity care plans dated February 15, 2021, addressing activities to be encouraged considering COVID-19 restrictions.  P. Ex. 1 at 41-42.  The care plans list as a problem or concern that residents are remaining in their rooms due to COVID-19 with decreased social contact and need for human interaction.  Interventions included inviting Resident 1 out of his room when possible following infection control protocols, offering in-room one-on-one activities, offering television and other material of interest, and assisting with communicating with family.  A care plan dated February 19, 2021, shows that Resident 1 was at risk for COVID-19 due to his advanced age and multiple comorbidities and that he was noncompliant with social distancing and wearing a mask.  Interventions included encouraging him to stay in his room and cover his face when staff were in the room; reminding and assisting with hand washing; explaining health department policies, procedures, and recommendations; monitoring for COVID-19 and reporting to the physician if noted; continuing to follow policy on visitor restriction and social distancing of six feet; 14 days of contact isolation for Resident 1 as a new admission; staff to wear a mask; encouraging family to use alternate means of communication; and encouraging in-room activities. P. Ex. 1 at 43-44.

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Resident 1 had a negative test for SARS-CoV-2 on February 24, 2021, three days after the survey concluded.  P. Ex. 1 at 59.  He also tested negative on May 14, 2021.  P. Ex. 1 at 88.

Temecula Valley Hospital records show that Resident 1 was admitted on February 1, 2021, after he was found wondering around the neighborhood in a state of confusion.  P. Ex. 2 at 1, 14.  He was discharged to Petitioner on February 11, 2021.  P. Ex. 2 at 2, 15.  He tested negative for SARS-CoV-2 on February 1 and 9, 2021.  P. Ex. 2 at 16, 67, 71, 79-80, 95.

Resident 2

Resident 2 was admitted to Petitioner on October 26, 2020.  He was 86 years old when admitted.  He was assigned to room 109 bed B – the same room as Resident 1.  CMS Ex. 3 at 1; CMS Ex. 9.  Resident 2 had multiple diagnoses including heart disease and heart failure, chronic obstructive pulmonary disease that required oxygen, dementia, and a history of stroke.  CMS Ex. 5 at 1-2.  He had a physician’s order from December 11, 2020, for indefinite contact/droplet isolation.  CMS Ex. 6.

Petitioner placed in evidence additional records for Resident 2.  He tested negative for SARS-CoV-2 on October 19, 2020, November 6, 2020, February 24, 2021, March 3, 2021, and May 14, 2021.  P. Ex. 3 at 1-6.  Resident 2 was given COVID-19 vaccines on January 17 and February 7, 2021.  P. Ex. 3 at 7-8.

Petitioner’s IPCP

Petitioner’s IPCP related to COVID-19 is in evidence as CMS Ex. 8.  The document is not dated, but I infer it was Petitioner’s IPCP in effect at the time of the survey that was obtained by the Surveyor because it was placed in evidence by CMS without objection by Petitioner.

Petitioner stated it adhered to federal, state, and local recommendations for admissions, visitation, and precautions including contact, droplet, and airborne precautions.  Petitioner’s stated policy was “to minimize exposures to respiratory pathogens and promptly identify residents with clinical features and an epidemiologic risk for COVID‑19.”  CMS Ex. 8 at 1. 

According to Petitioner’s IPCP, a person with COVID-19 symptoms (symptomatic) who had a positive test for SARS-CoV-2 was presumed to be contagious.  A person without COVID-19 symptoms (asymptomatic) who tested positive for SARS-CoV-2 was also treated as positive and presumed to be contagious.  A person who had a negative test for

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SARS-CoV-2 was presumed to be negative and not contagious.  However, an asymptomatic person with a negative test but in a group setting where an outbreak27 of COVID-19 occurred may need to be retested.  The IPCP provided that a symptomatic person with a negative test for SARS-CoV-2 should be isolated until a confirmatory test occurred.  CMS Ex. 8 at 2-3.  A resident who refused to take a COVID-19 test was treated as suspect for COVID-19, placed on contact and droplet isolation, and monitored for 14 days.  CMS Ex. 8 at 7.

Petitioner’s policy provided that it would plan for separate housing for COVID-19 positive residents, COVID-19 negative residents, and residents whose status was unknown.  If a newly admitted resident was not tested by the hospital within 72 hours prior to admission to Petitioner, the resident was to be tested by Petitioner upon admission.  Residents newly admitted from the hospital were to be quarantined in a single room if available or a separate observation area for 14 days from the last potential exposure to COVID-19 and then have a negative test before release from quarantine.  The total quarantine period could include the hospital days if according to the local health department or the hospital infection preventionist and occupational health program report there were no suspected or known cases at the hospital among patients or staff, it was verified that the hospital screened new admissions and monitored patients for hospital-onset COVID-19, and had designated COVID-19 units with dedicated staff and minimal cross-over by staff.  CMS Ex. 8 at 4.

Petitioner’s IPCP provides that residents are to be separated into cohorts28 according to their COVID-19 status.  The IPCP requires that residents be educated to wear face covering in public areas and during care when possible, to practice social distancing, and perform hand hygiene.  Petitioner’s IPCP provides that “[n]o group activities (internal or external) or communal dining will occur in the facility at this time.”  CMS Ex. 8 at 5.  Subsequently, the IPCP provides that group activities including communal dining may occur for residents who have fully recovered from COVID-19 or are not on isolation or quarantine, with social distancing of at least six feet, appropriate hand hygiene, and face coverings.  CMS Ex. 8 at 19.  The subsequent provision seems inconsistent with the prior provision.  But reading each provision in context and based on testimony of Petitioner’s administrator, director of nursing, and infection preventionists discussed later, I conclude

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that the first provision prohibited communal activities and dining throughout the facility at the time of the issuance of the policy and at the time of the survey.  I conclude that the subsequent provision only allowed communal activities and dining in very specific circumstances and did not apply at the time of the survey.

Petitioner’s IPCP required that staff use appropriate PPE when interacting with residents (to the extent PPE was available and consistent with CDC guidance on conserving PPE), and staff was required to wear a facemask while in the facility during the declared COVID-19 emergency.  Full PPE was to be worn while caring for a resident with known or suspected COVID-19.  The IPCP provides that if COVID-19 transmission occurs in the facility, then staff should wear full PPE while caring for all residents irrespective of COVID-19 diagnosis or symptoms on the unit involved or the entire facility depending on the circumstances.  CMS Ex. 8 at 9.  The IPCP requires that staff wear at a minimum a surgical mask and face shield when interacting with any resident.  CMS Ex. 8 at 19.

Evidence of National and State Standards

The parties placed in evidence multiple documents that provide evidence of national and state standards for infection control specifically related to COVID-19.  It is not alleged by either party that the guidance of CMS, CDC, or CDPH placed in evidence was binding as law.

On August 26, 2020, CMS issued a memorandum (QSO-20-38-NH) to the state survey agency directors with instruction to communicate the policy to survey and certification staff, state agency managers, and state agency and CMS training coordinators.  The memorandum does not show on its face that it was sent to skilled nursing or nursing facilities and no evidence was presented by CMS to show that it was intended for or distributed to long-term facilities.  CMS Ex. 10 at 1, 22.  The subject line of the memorandum indicates it discusses CMS’ interim final rules being promulgated to address the COVID-19 public health emergency, specifically long-term care facility COVID-19 testing.  The memorandum discusses a pending revision of the regulations.  But the memorandum is not itself rule-making under section 1871 of the Act and established no substantive legal requirements binding upon long-term care facilities.  See Allina, 587 U.S. 566.  Attached to the memorandum was a revised COVID-19-focused survey tool for use by surveyors.  CMS Ex. 10 at 1, 12-22.  The tool requires a surveyor to determine whether a long-term care facility has a plan for cohorting and managing care for residents with COVID-19.  The tool does not reflect any requirement for a plan for cohorting COVID-19 negative residents, other than the implication that COVID-19 positive and negative residents should be separated within a facility.  CMS Ex. 10 at 17.

The SOM provides helpful guidance regarding the use of transmission-based precautions.  The CMS policy specifies that the term “transmission-based precautions” is to be used by surveyors rather than the term “isolation” which appears in the CMS regulations.

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Transmission-based precautions are those used to prevent or control infections based on the possible means of transmission.  The three means of transmission discussed are airborne, contact, or droplet transmission.  Transmission-based precautions are in addition to standard precautions, that is, infection prevention practices, used with all residents whether they have a suspected or confirmed or presumed infection status.  Standard precautions include, for example, hand hygiene, gloves, gowns, masks, eye protection, and face shields.  Standard precautions also involve disinfecting or sterilizing reusable equipment.  CMS Ex. 13 at 5.  CMS says that transmission-based precautions should be used when a resident develops signs and symptoms of an infection that is transmissible or arrives at a long-term care facility with such symptoms.  Therefore, a resident who has signs and symptoms consistent with influenza should be asked to wear a face mask when the resident leaves his/her room, even before confirmation by testing.  CMS specifies that it is up to the facility to identify the type of transmission-based precautions to be implemented based on the pathogen involved.  CMS policy is that transmission-based precautions should be the least restrictive possible and for the minimum amount of time.  CMS Ex. 13 at 16-17.  Significantly, CMS states that “once the resident is no longer a risk for transmitting the infection . . . removing transmission-based precautions is required in order to avoid unnecessary involuntary seclusion.”  CMS Ex. 13 at 17.  A facility is encouraged to take action to avoid negative psychosocial effects of isolation for a resident subject to transmission-based precautions.  Negative effects include boredom, anger, withdrawal, or depression.  CMS Ex. 13 at 17.  Cohorting or sharing a room with a roommate with limited risk factors for contracting the pathogen is also suggested by CMS.  CMS Ex. 13 at 17.  CMS recognized in the SOM that educating a resident on the use of transmission-based precautions is limited by the resident’s capacity to understand and comply.  CMS Ex. 13 at 18.

Petitioner placed in evidence the CDC’s “Interim Infection Prevention and Control Recommendations to Prevent SARS-CoV-2 in Nursing Homes,” that was updated March 29, 2021 (P. Ex. 4), which was after the survey of Petitioner in February 2021 (CMS Ex. 2).  Although it is not clear what changes were made to this document as part of the update, CMS did not object to my consideration of relevant information in the document.  I find that Petitioner’s IPCP is consistent with the CDC’s recommendations.  The document describes “source control” (a term found in various items of evidence) as the use of a well-fitting cloth mask, facemask, or respirator to cover a person’s mouth and nose to prevent spreading respiratory secretions, and depending on quality, infectious droplets, and particles produced by infected people.  The CDC recommended that everyone in a healthcare facility wear source control measures even if they have no COVID-19 symptoms.  The CDC states that residents should wear source control upon arrival and throughout their stay, but only if tolerated.  The CDC states source control should not be placed on anyone who cannot wear it safely including those with a disability or underlying medical condition that precludes wearing a mask.  P. Ex. 4 at 4-5.  The CDC recommended social distancing of six feet for residents and staff.  P. Ex. 4 at 5.  The CDC stated that communal dining and group activities were permissible for residents

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who do not have suspected or confirmed COVID-19, including those fully recovered and those who have had no close contact with an infected person.  If there is a possibility that those present have not been fully vaccinated, social distancing, source control, and hand hygiene were recommended.  P. Ex. 4 at 5.  The CDC recommended that a resident who had close contact with someone with SARs-CoV-2 should be placed in quarantine for 14 days after their exposure, ideally in a single-person room and, if no single is available, they may stay in their current room subject to monitoring.  Only confirmed infected residents should be placed in a COVID-19 care unit.  Residents are released from quarantine if they have no fever or symptoms for 14 days.  P. Ex. 4 at 10-11.  The CDC recommended that all new admissions should be placed in quarantine for 14 days even if they have a negative test at admission.  Exceptions are residents within three months of a SARS-CoV-2 infection and fully vaccinated residents.  P. Ex. 4 at 11.   

CDC guidance for testing for COVID-19 in nursing homes is in evidence as P. Ex. 5.  It is not clear when this the document was issued, but it may have been around July 1, 2020, as that date appears on each page of the document.  The subtitle for the document is “Considerations for Use of Test-Based Strategies for Preventing SARS-CoV-2 Transmission in Nursing Homes.”  The guidance concerns how to use testing to support infection control in a long-term care facility.  P. Ex. 5.  The details are not important for this decision.

On May 20, 2020, the CDC issued an update of “Considerations for Memory Care Units in Long-term Care Facilities.”  The CDC recognized that infection prevention strategies are challenging to implement in memory care units where multiple residents with cognitive impairments reside together.  The CDC stated that memory care residents can have difficulty following infection prevention recommendations such as wearing a mask, social distancing, and hand hygiene.  The CDC recognized that changes in memory care resident routines can cause fear and anxiety with resulting depression, agitation, aggression, and wandering.  CDC provided a list of considerations, including maintaining routines as much as possible, reminding and assisting with frequent hand hygiene, social distancing, the use of cloth face coverings if tolerated, use of dedicated staff, structured activities in resident rooms or at staggered times to maintain social distancing, providing safe ways for residents to allow residents to continue walking, limiting residents in a common space or space them at least six feet apart to the extent feasible, frequent cleaning of often touched surfaces, and ensuring access to necessary medical care and emergency services.  CDC recommended the weighing the risks and benefits of moving a resident out of a memory care unit if the resident is suspected or confirmed COVID-19 positive.  The CDC states that a facility may determine it is safer to maintain a resident with suspected or confirmed COVID-19 on the memory care unit with dedicated personnel.  P. Ex. 6.

CMS and CDC recommendations to state and local governments and long-term care facilities were issued on April 2, 2020.  CMS and CDC recommended that:

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Long-term care facilities comply with CMS and CDC guidance related to infection control;

State and local leaders consider the needs of long-term care facilities for PPE and COVID-19 tests;

Long-term care facilities should immediately implement symptom screening for anyone in or entering a facility, including residents, staff, visitors (except emergency medical services), and contractors;

All long-term care facility staff should use appropriate PPE when interacting with residents and wear a facemask while in the facility, to the extent PPE is available and consistent with CDC guidance on conservation of PPE;

Separate staff be used for COVID-19 positive residents;

COVID-19 positive residents and those with unknown COVID-19 status be separated from negative residents by using separate facilities or units;29 and

If possible, new admissions and readmissions should be isolated for 14 days in their room in a COVID-19 positive facility if their COVID-19 status is unknown.30

P. Ex. 7.

CDC guidance for wearing masks to slow the spread of COVID-19, which was revised April 19, 2021, was placed in evidence by Petitioner without objection by CMS.  It is not possible to tell how the guidance was changed in the April 2021 revision, which was after

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the survey.  But CMS raised no objection to my consideration of the document, and it was offered as evidence by Petitioner.  The document provided general guidance on wearing masks, the effectiveness of masks, the purpose for wearing a mask, who should and should not wear a mask, types of masks, other face protection such as shields and goggles, and mask adaptations and alternatives.  The CDC recognized it may be difficult for some children and people with cognitive or behavioral issues to wear a mask.  CDC recommends that children under two years old and persons with a disability who cannot wear a mask due to their disability, should not do so.  P. Ex. 8.

On May 22, 2020, the CDPH issued a memorandum to long-term care facilities recommending testing for staff and residents.  CDPH recommended, among other things, testing all new admissions prior to admission.  A resident transferred from a hospital that was not tested by the hospital must be tested by the facility and quarantined for 14 days and then retested.  If negative, the resident can be released from quarantine.  CDPH stated that a facility may consider days in the hospital as part of the resident’s quarantine period under certain circumstances.  CDPH recommended testing of symptomatic or exposed residents.  P. Ex. 9 at 1-2.

On September 12, 2020, the CDPH issued a memorandum for long-term care facilities that included new guidance regarding the admission of new and readmitted residents.  For an admission from the hospital, if the hospital did not test for COVID-19 with 72 hours of the transfer to the facility, the facility must test.  A resident newly admitted from the hospital should be quarantined in a single room or separate observation area for 14 days from the last potential exposure and then retested with release from quarantine if the test was negative.  CDPH does not state or imply that a resident subject to such quarantine should be in a COVID-19 unit or facility.  The CDPH does not specifically state whether the quarantine requirement applies to a resident tested by the hospital within 72 hours of transfer and the result is negative.  It is also not clear what the CDPH means by the “last potential exposure,” that is, whether that includes only known exposure to someone with known or suspected COVID-19, or merely the possibility that there might have been someone the new resident encountered at the hospital prior to transfer or elsewhere during transfer whose COVID-19 status is unknown.  However, the CDPH states that testing and quarantine are not required for residents readmitted after hospitalization or who are out of the facility for care unless there is suspected or confirmed COVID-19 transmission at the outside facility.  CDPH stated that testing and quarantine were also not necessary for residents who were hospitalized that were tested positive for COVID-19 but met the requirements for discontinuation of isolation and precautions prior to being admitted to the long-term care facility.  Facilities were encouraged to regularly screen by testing and cohort residents who regularly leave the facility for dialysis and test residents

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following a hospital or emergency department visits.31  P. Ex. 10 at 2.  CDPH recommended that residents who tested positive for COVID-19 be isolated for at least ten days after symptom onset, the resident has no fever for 24 hours without fever reducing medication, and all other symptoms of COVID-19 have improved.  The quarantine period for a positive resident was 10 days running from the date of the test if the resident was asymptomatic.  Retesting was not recommended within three months from the date a resident who was previously diagnosed with COVID-19 no longer had symptoms or from the date of the positive test for a resident who was always asymptomatic.  CDHP also said no quarantine was required for those who were previously diagnosed or tested positive even if a close contact occurred with an infected person, but CDHP did not specify a period for when this was the case.  P. Ex. 10 at 3.

I conclude based on my review of the evidence of national and state standards related to COVID-19 infection control, that Petitioner’s IPCP was consistent with those standards and in some cases clearer.  The fact no deficiency based on an inadequacy of Petitioner’s IPCP was cited by the Surveyor is consistent with my review of the evidence.

Surveyor Observations

The Surveyor cited noncompliance under Tag F880 based on violations of 42 C.F.R. § 483.80, alleging the following failings by Petitioner:

Petitioner failed to ensure that Residents 1 and 2, “who were placed in contact and droplet isolation and quarantined for 14 days due to potential exposure to COVID‑19, were kept isolated from the other residents” in the secure dementia unit of Petitioner where the two resided.  CMS Ex. 2 at 5.

Petitioner failed to ensure Residents 1 and 2 practiced social distancing and used a mask (source control) during communal activities and dining which were occurring during the survey.  CMD Ex. 2 at 5.

Petitioner erred by placing Resident 1 in quarantine in Resident 2’s room.  CMS Ex. 2 at 7. 

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One staff member failed to don appropriate PPE while working in Petitioner’s yellow zone (unknown COVID-19 status – quarantine).  CMS Ex. 2 at 7, 19-20.

The Surveyor recorded additional observations in the SOD as the bases for the allegations of noncompliance.

Residents 1 and 2 were not kept isolated from other residents in the secure unit.

Residents 1 and 2 did not maintain social distancing and wear a mask.

Communal activities and dining were occurring during the survey.

CMS Ex. 2 at 5. 

The certified occupational therapy assistant (COTA) the Surveyor saw enter the room of a resident (in the yellow zone on contact and droplet precautions) with no gown admitted to the Surveyor that she should have been wearing a gown.

CMS Ex. 2 at 19-20. 

The Surveyor recorded her observations in the SOD.  On February 18, 2021, at 10:55 a.m. she saw 15 residents participating in activities in the activity/dining room on the secure unit.  Residents, including Resident 1, were not separated by six feet and none were wearing masks.  Two certified nursing assistants (CNAs), an activities aide, and a licensed vocational nurse (LVN) were present in the room and the surveyor observed no attempt to redirect the residents.  CMS Ex. 2 at 10-11.  On February 18, 2021, at 1:47 p.m., the surveyor observed 18 residents in the secure unit dining room finishing their lunch meal.  The residents were not six feet apart and were not wearing a mask.  CMS Ex. 2 at 12.  The surveyor also recorded that one of Petitioner’s infection preventionists told her on February 18, 2021, at 2:00 p.m. that all communal activities and dining had been cancelled throughout the building including the secure unit.  The Surveyor recorded that both Petitioner’s infection preventionists denied knowing that any communal activities or dining was occurring in the secure unit.  CMS Ex. 2 at 13-14.  The Surveyor also recorded that the activity director told her she was unaware that communal activities were occurring in the secure unit as staff was not supposed to be doing group activities.  CMS Ex. 2 at 14-15.  The Surveyor recorded that on February 18, 2021, at 10:55 she observed a certified occupational therapy assistant enter a room without a gown even though a sign on the doorway indicated the residents were on contact and droplet isolation precautions.  CMS Ex. 2 at 19.

CMS presented the declaration of the Surveyor in which she discusses her findings and conclusions recorded in the SOD.  The Surveyor’s testimony is consistent with her recording in the SOD.  CMS Ex. 1.  The Surveyor explained that Petitioner had a yellow

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and a green zone.  Yellow zone residents were quarantined in their rooms with contact and droplet precautions for 14 days after admission.  The green zone, which included the secure unit for residents, was for residents that were negative for COVID-19 or residents who had recovered from the virus.  CMS Ex. 1 at 2 ¶ 8.  She testified that on February 18, 2021, she saw group activities in the secure unit dining room.  CMS Ex. 1 at 3 ¶¶ 15‑16.  The Surveyor concluded regarding the alleged noncompliance under Tag F880 that although Resident 1 and 2 were supposed to be in quarantine with contact and droplet precautions because their COVID-19 status was unknown, they were allowed to mingle with the other 44 residents and the staff of the secure unit.  CMS Ex. 1 at 7.  The Surveyor also testified regarding the staff member who failed to don a gown consistently with her observations recorded in the SOD.  CMS Ex. 1 at 6 ¶¶ 32-33.

I find that the Surveyors recording of her observations in the SOD and her declaration are fully credible.

Petitioner’s Witnesses

Petitioner presented the declaration of Trina Tran LVN, one of Petitioner’s two infection preventionists.  P. Ex. 14.  She explained Petitioner has two infection preventions due to the size of the facility and they work together.  The facility had two floors and multiple units.  On the first floor was the memory care unit (secure unit) and two rehabilitation units.  The secure unit housed residents who suffer from dementia and are wanderers and doors were locked to keep the residents in the facility.  The second floor housed long-term care residents.  P. Ex. 14 at 1 ¶ 3.   She testified that prior to the survey at issue, CDPH and the public health department were invited to visit Petitioner’s secure unit to observe and give guidance.  She testified that the CDPH and county health department representative observed that residents in the secure unit wandered and verbalized no objections to Petitioner continuing to admit residents to that unit.  But she testified that the state and county health officials were told that all communal or group activities had been stopped.   P. Ex. 14 at 2 ¶ 6.  LVN Tran did not dispute that the Surveyor saw communal activities occurring during the survey.  LVN Tran did not address whether the communal activities observed by the surveyor violated Petitioner’s IPCP.  LVN Tran testified that the example of the certified occupational therapy assistant who failed to wear a gown into a room of resident on contact and droplet isolation was an isolated incident that did not pose immediate jeopardy.  P. Ex. 14 at 5 ¶ 12.  She did not dispute the surveyor’s observations or assert that the incident did not pose a risk for more than minimal harm.

Petitioner also presented the declaration of Rachel Aguinaldo, LVN, Petitioner’s second infection preventionist.  P. Ex. 15.  Her description of Petitioner’s physical facility is consistent with that of LVN Tran.  She testified that all new admissions were placed in isolation in accordance with Petitioner’s IPCP.  P. Ex. 15 at 1 ¶¶ 3-4.  She also testified that the CDPH and local health departments visited Petitioner at least three times to

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review Petitioner’s infection control practices.  CDPH cited no deficiency related to Petitioner’s inability to keep secure unit residents in their rooms with their masks on.  P. Ex. 15 at 3 ¶ 8.  She testified that Resident 1 had two negative COVID-19 tests at the hospital; he was asymptomatic; he required a secure unit as he was a wanderer; no private room was available; Resident 2 (already on contact and droplet precautions) was fully vaccinated and tolerated roommates.  P. Ex. 15 at 3-4 ¶ 10.  LVN Aguinaldo testified that “[t]here was no communal dinning since early in the pandemic and continuing through the time of the survey.”  P. Ex. 15 at 4 ¶ 12.  She testified that she observed one-on-one activities in resident rooms and not group activities in the unit dining room.  She testified staff knew that there were to be no group or communal activities or dining.  P. Ex. 15 at 4 ¶ 12.  LVN Aguinaldo did not deny that the Surveyor observed group or communal activities during the survey.  She opined that the one instance of the certified occupational therapy assistant failing to wear a gown should not be considered noncompliance.  But she did not explain why except that it was an isolated instance of a violation of Petitioner’s IPCP.  P. Ex. 15 at 4 ¶ 13.

Petitioner presented the declarations of Maria Davis, RN, Petitioner’s director of nursing.  P. Exs. 16, 24.  She testified Petitioner was a large facility with two floors, six nursing stations, over 200 employees, and an average resident census of 270-280.  P. Ex. 16 at 1 ¶ 4.  She testified that ‘[f]rom the start of the pandemic, [Petitioner] had stopped communal dining and group activities.”  P. Ex. 16 at 2 ¶ 12.  She did not deny that the Surveyor observed communal activities and dining.  She testified that both the CDPH and county health official conducted surveys and observed their operations and made no objections to Petitioner admitting residents to the secure unit.  P. Ex. 16 at 2 ¶ 13.  She opined that there was no noncompliance under Tag F880 but did not address the fact that Petitioner’s IPCP was not being followed in the secure unit because communal activities and dining were occurring at the time of the survey.  P. Ex. 16 at 2 ¶ 15.  She admitted that Resident 1 needed to be quarantined in his room but explained that was difficult.  She pointed out that Resident 1 tested negative for COVID-19 twice at the hospital, was asymptomatic, and he did not develop COVID-19.  P. Ex. 16 at 4 ¶ 16.  RN Davis testified that the incident of the staff member who failed to wear a gown into a room for which contact and isolation precautions were in effect was an isolated incident and should not be considered noncompliance, but she does not explain the basis for her opinion.  P. Ex. 16 at 4 ¶ 17.

Petitioner presented the declaration of Teja Singh, MD, Petitioner’s medical director.  P. Ex. 22.  Dr. Singh testified he saw no issues with staff implementing infection control protocols.  P. Ex. 22 at 1 ¶ 4.  He testified he was Resident 1’s treating physician and he was comfortable with him being placed in Petitioner’s secure unit.  He further testified that Petitioner did not accept symptomatic residents, the hospital tested new admissions for COVID-19 prior to transfer to Petitioner, and many residents on the secure unit were vaccinated.  P. Ex. 22 at 2 ¶¶ 6-7.  However, he did not address the fact that communal activities and dining occurred in the secure unit during the survey.

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Petitioner presented the declaration of Micah Rhead, Petitioner’s administrator during the survey.  P. Ex. 23.  He testified that Petitioner stopped communal dining and activities before the CDC, CMS, and CDPH made that recommendation.  P. Ex. 23 at 2 ¶ 4.  Following the initial outbreak of COVID-19 at Petitioner in April 2020, Petitioner worked with the CDHP and county health department to determine the best way to handle its secure unit.  Petitioner offered to close the unit, but the state and county wanted it to remain open as it was one of the few memory care units in San Diego.  The CDHP and local health departments conducted many surveys and found no deficiencies related to infection control in the secure unit, and no cases of COVID-19 occurred in the secure unit.  P. Ex. 23 at 3 ¶ 7.  He opined that there was no deficient practice and no immediate jeopardy.  P. Ex. 23 at 3 ¶¶ 8-10.  However, he did not address the fact that communal activities and dining occurred in the secure unit during the survey.

Petitioner also presented the declarations of two expert witnesses – Heather M. Saunders, RN and Karl Steinberg, MD.  P. Exs. 18, 20.

Heather M. Saunders, RN, has a Bachelor of Science in Nursing and a Masters in Public Health.  She was the Director of Infection Control at the Johns Hopkins Office of Population Health.  P. Ex. 18 at 1.  Based on my review of her curriculum vitae and declaration, I accept her as an expert and qualified to render opinions regarding infection control in a medical environment.  P. Exs. 18, 19.  She opined that there was no immediate jeopardy to Petitioner’s residents based on the noncompliance cited under either Tag F880 or Tag F886.  P. Ex. 18 at 3 ¶ 6.  She opined Petitioner should not be penalized for its placement of Resident 1 or the inability to “perfectly isolate” the residents in the secure unit.  P. Ex. 18 at 5-6 ¶ 10.  She explained the difficulty of ensuring residents with dementia maintain social distancing and wear a mask.  She opined that it is unreasonable to expect perfect compliance with masking and social distancing in a population with dementia and certain psychiatric conditions.  P. Ex. 18 at 7-8 ¶ 12.  RN Saunders’ declaration does not reflect that she considered that the Surveyor observed residents on Petitioner’s secure unit engaged in group activities and dining on February 18, 2021.  Therefore, I conclude that she has not opined that group or communal activities and dining posed no risk for more than minimal harm.  Her testimony is fully credible.  But her failure to consider that communal activities and dining were occurring in the secure unit at the time of the survey prevent any opinion that Petitioner was not in violation of 42 C.F.R. § 483.80, that a violation posed no risk for more than minimal or harm, or that noncompliance did not pose immediate jeopardy from being given any weight.

Dr. Steinberg has certificates as medical director for long-term care and hospice.  Based on his declaration and curriculum vitae, I accept him as an expert and qualified to render opinions regarding geriatric and palliative medicine and health care for residents in a long-term care environment.  P. Exs. 20, 21.  He concurred with the opinions expressed

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by RN Saunders.  P. Ex. 20 at 4 ¶ 11.  He opined there was no immediate jeopardy related to the noncompliance cited under Tag F880.  He also opined that there was no noncompliance under Tag F880.  P. Ex. 20 at 4-5 ¶¶ 12-16.  He discussed the reasonable medical judgment to place Resident 1 in the secure unit as Resident 2’s roommate.  He also discussed the well-recognized challenges associated with getting demented or similarly disordered individuals residing on the secure unit to practice social distancing and masking.  He did not discuss, and from my perspective failed to consider, that the Surveyor saw residents on the secure unit engaged in group activities and dining, even though that was contrary to Petitioner’s IPCP.  He did not opine that group or communal activities and dining posed no risk for more than minimal harm or immediate jeopardy.  His testimony is fully credible.  But his failure to consider that communal activities and dining were occurring in the secure unit at the time of the survey prevent any opinion that Petitioner was not in violation of 42 C.F.R. § 483.80, that a violation posed no risk for more than minimal or harm, or that noncompliance did not pose immediate jeopardy from being given any weight.

Summary of Key Findings for Analysis

1. Each of Petitioner’s witnesses testified about the challenges of dealing with demented residents of the secure unit, including maintaining social distancing, wearing masks, and keeping residents quarantined in their rooms.  The evidence shows that Petitioner was well-aware of the challenges.  P. Exs. 14‑16, 22-23.
2. None of Petitioner’s witnesses disputed the Surveyor’s report of her observation of communal activities and dining occurring in the secure unit on February 18, 2021.  CMS Ex. 1 at 3 ¶¶ 15-16; CMS Ex. 2 at 10-11.
3. Petitioner’s IPCP provided that no communal activities or dining were to occur in the facility.  CMS Ex. 8 at 5.
4. Petitioner’s witnesses testified that communal activities and dining were not to occur in the facility, that was Petitioner’s policy and practice beginning early in the pandemic and continuing through the survey, and the health department was informed of that prohibition.  P. Ex. 14 at 2 ¶ 6; P. Ex. 15 at 4 ¶ 12; P. Ex. 16 at 2 ¶ 12; P. Ex. 23 at 2 ¶ 4.
5. Petitioner’s policy prohibiting communal activities and dining shows that Petitioner recognized a risk for transmission of infectious disease if those activities were permitted on any unit of the facility, not just the secure unit where maintaining social distancing and consistent use of masks by residents was much less likely.  CMS Ex. 8 at 1-2 (mild to severe illness), 8 (severe symptoms may require transfer to hospital). 

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6. There is no dispute the Surveyor observed a staff member enter a room posted for contact and droplet transmission-based precautions without donning a gown or that donning a gown in such circumstances was consistent with and required by Petitioner’s IPCP which incorporated national standards.  CMS Ex. 1 at 6 ¶¶ 32-33; CMS Ex. 2 at 19; P. Ex. 14 at 5 ¶ 12; P. Ex. 15 at 4 ¶ 13; P. Ex. 16 at 4 ¶ 17; P. Ex. 4 at 10.
7. There is no dispute that at the time of the survey it was generally accepted that contracting COVID-19 could cause more than minimal harm particularly for a resident in a long-term care facility.  P. Ex. 4 at 1; P. Ex. 5 at 1; P. Ex. 7 at 1; P. Ex. 9 at 1; P. Ex. 10 at 1.
   2. Analysis

The evidence shows that Petitioner exerted extensive effort and achieved commendable results in dealing with COVID-19 in its facility.  However, the fact that the Surveyor witnessed communal activities and dining occurring in the secure unit on February 18, 2021, shows that Petitioner failed to implement its IPCP.  Petitioner’s failure to ensure staff complied with the policy that no communal activities or dining were to occur posed a risk for more than minimal harm by increasing the risk that residents of the secure unit would contract COVID-19.

The analysis of the alleged noncompliance alleged under Tag F880 based on violation of 42 C.F.R. § 483.80 is not complicated.

The infection control regulation requires that Petitioner both establish and maintain, i.e., implement, its IPCP.  Golden Living Center – Superior, DAB No. 2768 at 5, 7-8 (2017) (failure to implement is failure to maintain).  The purpose of the IPCP is to ensure Petitioner’s residents have a safe, sanitary, and comfortable environment in which the development and transmission of communicable diseases and infections is mitigated.  42 C.F.R. § 483.80.  In this case, Petitioner’s problem is that the evidence shows Petitioner failed to implement its IPCP because communal activities and dining were observed by the Surveyor in the secure unit on February 18, 2021, during the survey.  Petitioner argues that no communal activities or dining occurred.  P. Br. at 13.  But Petitioner presented no evidence rebutting the Surveyor’s observations.  None of Petitioner’s witnesses testified they were present in the secure unit when the Surveyor made her observations or had other direct evidence to rebut the Surveyor’s testimony that she saw communal activities and dining on February 18, 2021.  And I have no reason not to accept as credible the Surveyor’s reports of her observations.

There is no issue that Petitioner’s IPCP met the minimum requirements of 42 C.F.R. § 483.80(a).  There is also no dispute that the evidence before me shows no outbreak of

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COVID-19 in the secure unit.  However, the fact Petitioner had an adequate IPCP and no outbreak of COVID-19 in the secure unit during the period covered by the records in evidence before me does not permit me to resolve this alleged noncompliance in Petitioner’s favor.  The regulation, as interpreted by the Board, requires that Petitioner’s adequate IPCP also be implemented.  Golden Living – Superior at 7-8.  Petitioner failed to ensure that no communal activities and dining occurred in its facility as required by its IPCP.  Therefore, Petitioner violated 42 C.F.R. § 483.80.

The evidence supports a finding that Petitioner’s violation of 42 C.F.R. § 483.80 posed a risk for more than minimal harm.  The SOD reflects that the Surveyor found that Petitioner’s violation of 42 C.F.R. § 483.80 posed a risk for more than minimal harm as she alleged that the violation posed immediate jeopardy, i.e., a risk for serious harm or death.  CMS Ex. 2 at 3.  The Surveyor was not a registered nurse or have any noteworthy medical training.  But she was a trained surveyor required to develop and render an opinion based on her CMS training.  Therefore, her opinion as a surveyor is entitled to some weight.  Weightier, however, is the fact that Petitioner’s IPCP, the evidence of state and national standards, and the testimony of Petitioner’s staff and expert witnesses all support a finding that the risk posed by contracting COVID-19 was a risk for more than minimal harm, particularly among residents of a long-term care facility.  It is important to know that a facility remains in substantial compliance with program participation requirements so long as “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.  Noncompliance exists when a deficiency poses a risk to resident health or safety for more than minimal harm.  The regulation does not require consideration of the degree of risk posed by a violation of a participation requirement.  Rather, the regulation requires consideration of the level of harm to which residents are exposed if there is any risk due to a violation of a participation requirement.  In this case, there is no dispute that long-term care facility residents were at risk for contracting COVID-19.  The purpose of the requirement for Petitioner to have an IPCP was to mitigate or minimize the risk of residents contracting COVID-19 and other infectious diseases.  Petitioner’s failure to implement the IPCP posed a risk that infection could occur, even if it did not, and the pertinent level of risk is that posed by contracting COVID-19.  The evidence all shows that at the time of the survey, the risks associated with contracting COVID-19, particularly in a long-term care resident, ranged to potential severe harm or death.  Therefore, I conclude that Petitioner’s regulatory violation posed a risk for more than minimal harm and there was noncompliance that provided a basis for the imposition of an enforcement remedy.

Only brief consideration of the staff member who was observed by the Surveyor not to don a gown is necessary.  There is no dispute that the incident happened as alleged.  Petitioner offers no real excuse but urges it was only an isolated incident.  P. Br. at 20.  I do not suggest this was a minor incident.  However, because I have concluded that

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noncompliance existed based on the occurrence of communal activities and dining in violation of Petitioner’s IPCP, it is not necessary to consider this second example further.

6. If on further appeal it is determined that the statutory and regulatory violations should be overlooked or excused, I conclude CMS has not made a prima facie showing of a violation of 42 C.F.R. § 483.80(h) (Tag F886) or Petitioner has rebutted the prima facie showing.
7. Petitioner did not violate 42 C.F.R. § 483.80(h) (Tag F886). 

The Surveyor alleged noncompliance under Tag F886 based on a violation of 42 C.F.R. § 483.80(h) that she alleged posed immediate jeopardy.  The Surveyor alleged that when a resident tested positive for COVID-19 on January 29, 2021, and another resident tested positive on February 8, 2021, Petitioner failed to test “all residents in the facility who had previously tested negative and lived in other units of the facility.”  CMS Ex. 2 at 22.

Examination of the language of the regulation is necessary to determine what the substantive legal standard is that the Surveyor attempts to apply.  Pursuant to 42 C.F.R. § 483.80(h),32 Petitioner must:

[T]est residents and facility staff, including individuals providing services under arrangement and volunteers, for COVID-19.  At a minimum, for all residents and facility staff, including individuals providing services under arrangement and volunteers, the LTC facility must:

(1)  Conduct testing based on parameters set forth by the Secretary, including but not limited to:

(i)  Testing frequency;
(ii)  The identification of any individual specified in this paragraph diagnosed with COVID-19 in the facility;
(iii)  The identification of any individual specified in this paragraph with symptoms consistent with COVID-

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19 or with known or suspected exposure to COVID‑19;
(iv)  The criteria for conducting testing of asymptomatic individuals specified in this paragraph, such as the positivity rate of COVID-19 in a county;
(v)  The response time for test results; and
(vi)  Other factors specified by the Secretary that help identify and prevent the transmission of COVID-19.

(2)  Conduct testing in a manner that is consistent with current standards of practice for conducting COVID-19 tests;

(3)  For each instance of testing:

(i) Document that testing was completed and the results of each staff test; and
(ii) Document in the resident records that testing was offered, completed (as appropriate to the resident’s testing status), and the results of each test.

(4)  Upon the identification of an individual specified in this paragraph with symptoms consistent with COVID-19, or who tests positive for COVID-19, take actions to prevent the transmission of COVID-19.

(5)  Have procedures for addressing residents and staff, including individuals providing services under arrangement and volunteers, who refuse testing or are unable to be tested.

(6)  When necessary, such as in emergencies due to testing supply shortages, contact state and local health departments to assist in testing efforts, such as obtaining testing supplies or processing test results.

42 C.F.R. § 483.80(h)(1)-(6) (emphasis added).  The regulation does not list current standards of practice for testing for COVID-19.  The regulation does not state that if there is a COVID-19 outbreak, i.e., one positive test, that all residents who previously tested negative in the facility must be tested.  The regulation does not state that if a facility establishes separate cohorts for COVID-19 positive residents, COVID-19 negative residents, and those of unknown status, that if an outbreak occurs all previously negative residents must be retested in the cohort or the entire facility.  While it may be a good practice, the regulation includes no such substantive requirement.

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The Surveyor alleged that the requirement was found in the guidance in the CMS memorandum to state survey agency directors dated August 26, 2020 with the reference QSO-20-38NH.  CMS Ex. 10.  I note again that this memorandum is not addressed to long-term care facilities and contains no direction for state survey agencies to send it to long-term care facilities.  The memorandum does not have the status of a regulation and there is no evidence Petitioner received any notice of its contents.  Furthermore, the purpose of the memorandum was to discuss the new interim regulation 42 C.F.R. § 483.80(h).  Assuming Petitioner did receive notice of the content of the memorandum, an assumption I will not make, Table 1 of the memorandum indicates that if there is an outbreak, i.e., any new case in a facility, “all residents that previously tested negative” should be tested every three to seven days “until no new cases are identified.”  CMS Ex. 10 at 3.  Thus, the memorandum attempts to add requirements to the regulation or, at a minimum, establish guidance that the evidence does not show was actually delivered to long-term care facilities.  It is also significant that the language of Table 1 does not specify that all residents in the entire facility who previously tested negative were to be tested or only those in the cohorts that had residents who previously tested negative or clarify whether the requirement even applied to residents who recovered from COVID-19 and then tested negative.

I conclude that 42 C.F.R. § 483.80(h) and CMS Ex. 10 do not establish a substantive requirement or a recommendation that all residents in a facility who previously tested negative must be tested when an outbreak occurs.  I conclude the regulation and CMS memorandum may not be interpreted to prevent a facility from exercising reasonable medical judgment to test repeatedly only those previously negative residents at risk for contracting COVID-19 based on the outbreak.

Furthermore, on February 19, 2021, during the survey, Petitioner communicated with the local health department in San Diego County and received approval of its practice for only testing previously negative residents on a unit where a COVID-19 outbreak occurred.  CMS Ex. 7 at 1.  The Surveyor dismissed the local health department approval because Petitioner had not updated its COVID-19 mitigation plan to document the approach.  The Surveyor read the message as requiring Petitioner to update its mitigation plan.  CMS Ex. 1 at 4 ¶ 21.  However, the message only stated that if Petitioner had “outlined this testing strategy in your mitigation plan, it would have been approved by licensing.”  CMS Ex. 7 at 1.  The message instructed Petitioner to inform the Surveyor that Petitioner’s testing protocol was approved by county licensing.  CMS Ex. 7 at 1.  I also note that 42 C.F.R. § 483.80(f) only requires a facility to annually review and update its IPCP.  The alleged failure to test and the local health departments acknowledgment of Petitioner’s testing protocol as acceptable occurred between January 29, 2021 and February 19, 2021, and the imposition of a requirement to update the IPCP in that window is not required by the regulation and is simply unreasonable.  The Surveyor indicated in her declaration that Petitioner’s IPCP or mitigation plan may have required

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testing of all COVID-19 negative residents in the facility.  CMS Ex. 1 at 4 ¶ 21.  However, my review of CMS Ex. 8 at 8, Petitioner’s IPCP, reflects no such requirement.

I conclude that evidence shows no violation of 42 C.F.R. § 483.80(h).

8. Petitioner has not met its burden to show that the declaration of immediate jeopardy related to the noncompliance cited under Tag F880 was clearly erroneous.

The surveyor and CMS determined that Petitioner’s noncompliance amounted to immediate jeopardy on February 18 and 19, 2021.  There is no dispute that the surveyor found that immediate jeopardy was abated on February 20, 2021, and CMS agreed with that determination.  CMS Ex. 2 at 1-3, CMS Ex. 14 at 1.  Petitioner bears the heavy burden to show that the determination that Petitioner’s noncompliance under 42 C.F.R. § 483.80 posed immediate jeopardy on February 18 and 19, 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 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)(B)(ii).

Pursuant to 42 C.F.R. § 498.3(d)(10), a finding by CMS 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.  Rather, a finding of noncompliance that results 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 the declaration of immediate jeopardy 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 (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 & Human 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 76 at 3-4.

Many appellate panels of the Board have addressed “immediate jeopardy.”33  In Mississippi Care Ctr. of Greenville, DAB No. 2450 at 15 (2012), the Board commented:

CMS’s determination that a deficiency constitutes immediate jeopardy must be upheld unless the facility is able to prove that the determination is clearly erroneous.  42 C.F.R. § 498.60(c)(2); Woodstock Care Center.  The “clearly erroneous” standard means that CMS’s immediate jeopardy determination is presumed to be correct, and the burden of proving the determination clearly erroneous is a heavy one.  See, e.g., Maysville Nursing & Rehabilitation Facility, DAB No. 2317, at 11 (2010); Liberty Commons Nursing and Rehab Center — Johnston, DAB No. 2031, at 18 (2006), aff’d, Liberty Commons Nursing and Rehab Ctr. — Johnston v. Leavitt, 241 F. App’x 76 (4th Cir. 2007).  When CMS issued the nursing facility survey, certification, and enforcement regulations, it acknowledged that “distinctions between different levels of noncompliance . . . do not represent mathematical judgments for which there are clear or

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objectively measured boundaries.”  59 Fed. Reg. 56,116, 56,179 (Nov. 10, 1994).  “This inherent imprecision is precisely why CMS’s immediate jeopardy determination, a matter of professional judgment and expertise, is entitled to deference.”  Daughters of Miriam Center, DAB No. 2067 at 15 (2007).

The Board’s statement that the CMS immediate jeopardy determination is entitled to deference is subject to being misunderstood to limit ALJ and Board review of immediate jeopardy beyond what was intended by the drafters of the regulations.  In the notice of final rulemaking on November 10, 1994, the drafters of 42 C.F.R. § 498.60(c)(2), discussing the merits of the reviewability of deficiency citations, selection of remedy, and scope and severity, commented:

We believe that a provider’s burden of upsetting survey findings relating to the level of noncompliance should be high, however.  As we indicated in the proposed rule, distinctions between different levels of noncompliance, whether measured in terms of their frequency or seriousness, do not represent mathematical judgments for which there are clear or objectively measured boundaries.  Identifying failures in a facility’s obligation to provide the kind of high quality care required by the Act and the implementing regulations most often reflect judgments that will reflect a range of noncompliant behavior.  Thus, in civil money penalty cases, whether deficiencies pose immediate jeopardy, or are widespread and cause actual harm that is not immediate jeopardy, or are widespread and have a potential for more than minimal harm that is not immediate jeopardy does not reflect that a precise point of noncompliance has occurred, but rather that a range of noncompliance has occurred which may vary from facility to facility.  While we understand the desire of those who seek the greatest possible consistency in survey findings, an objective that we share, the answer does not lie in designing yardsticks of compliance that can be reduced to rigid and objectively calculated numbers.  Survey team members and their supervisors ought to have some degree of flexibility, and deference, in applying their expertise in working with these less than perfectly precise concepts.  For these reasons, we have revised the regulations to require an administrative law judge or appellate administrative review authority to uphold State or HCFA findings on the seriousness of facility

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deficiencies in civil money penalty cases unless they are clearly erroneous.

59 Fed. Reg. at 56,179 (emphasis added).  It is clear from this regulatory history that the drafters of 42 C.F.R. § 498.60(c)(2) ensured that the state agency or CMS determination that there was immediate jeopardy would receive deferential consideration by adopting the clearly erroneous standard of review.  Thus, caution must be exercised to ensure that the Board’s decisions in Mississippi Care Ctr. of Greenville, Daughters of Miriam Ctr., and other decisions that have mentioned deference relative to immediate jeopardy not be read to require deference for the determination that there was immediate jeopardy beyond that imposed by adoption of the clearly erroneous standard.  Mississippi Care Ctr., DAB No. 2450 at 15; Daughters of Miriam Ctr., DAB No. 2067 at 15.  Giving or requiring that the immediate jeopardy determination be given deference in addition to applying the “clearly erroneous standard” would be contrary to the intent of the drafters of the regulation, would significantly limit the review of the determination by an ALJ and the Board, and would impermissibly deny an affected party the due process right to review intended by the drafters of the regulation.

In the foregoing quotation from Mississippi Care Ctr. of Greenville, that panel of the Board states that the clearly erroneous standard means that “CMS’s immediate jeopardy determination is presumed to be correct, and the burden of proving the determination clearly erroneous is a heavy one.”  DAB No. 2450 at 15.  Similar formulations have been used in other Board decisions when referring to the “clearly erroneous standard.”  However, the Board’s characterization of the “clearly erroneous standard” in Mississippi Care Ctr. and other cases does not define the standard.  The “clearly erroneous standard” is described in Black’s Law Dictionary as a standard of appellate review applied in judging the trial court’s treatment of factual issues, under which a factual determination is upheld unless the appellate court has the firm conviction that an error was committed.  Black’s Law Dictionary at 269 (8th ed. 2004).

The Supreme Court has addressed the “clearly erroneous standard” in the context of the APA.  The Court described the preponderance of the evidence standard, the most common standard, as requiring that the trier-of-fact believe that the existence of a fact is more probable than not before finding in favor of the party that had the burden to persuade the judge of the fact’s existence.  In re Winship, 397 U.S. 358, 371-72 (1970); Concrete Pipe & Prods. of Cal., Inc. v. Constr. Laborers Pension Tr., 508 U.S. 602, 622 (1993).  The “substantial evidence” standard considers whether a reasonable mind might accept a particular evidentiary record as adequate to support a conclusion.  Consol. Edison Co. v. NLRB, 305 U.S. 197, 229 (1938); Dickinson v. Zurko, 527 U.S. 150, 162 (1999).  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, 395 (1948); Dickinson, 527

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U.S. at 162; Concrete Pipe, 508 U.S. at 622.  The clearly erroneous standard has been characterized by the Court as being stricter than the substantial evidence test and significantly deferential.  The Court stressed in discussing the clearly erroneous standard the importance of not simply rubber-stamping agency fact-finding.  The Court also commented that the APA requires meaningful review.34  Dickinson, 527 U.S. at 162 (citations omitted); Concrete Pipe, 508 U.S. at 622-23.

Various panels of the Board have recognized other principles applicable to the review of the immediate jeopardy issue.  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 & Human 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.  The synonym for likely is probable, which suggests a greater degree of probability that an event will occur than suggested by such terms as possible or potential.  Daughters of Miriam Ctr., DAB No. 2067 at 10.  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.  Woodstock Care Ctr., DAB No. 1726.

What is the meaning of serious injury, harm, or impairment as used in the definition of immediate jeopardy found in 42 C.F.R. § 488.301?  How does serious injury, harm, or impairment compare with “actual harm”?  On the first question, the Board recognized, in Yakima Valley Sch., that the regulations do not define or explain the meaning of the term “serious” as used in the definition of immediate jeopardy.  DAB No. 2422 at 8.  The Board suggested that the definitions may be unimportant because the Board has held that, under the clearly erroneous standard, once the state agency or CMS declares immediate jeopardy, there is a presumption that the actual or threatened harm was serious and the facility can only rebut the presumption of immediate jeopardy by showing that the harm or threatened harm meets no reasonable definition of the term “serious.”  Id. (citing

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Daughters of Miriam Ctr., DAB No. 2067 at 9).  In Daughters of Miriam Ctr., the Board discussed that the ALJ attempted in that case to define “serious,” finding meanings such as dangerous, grave, grievous, or life-threatening.  The Board noted that the ALJ stated that serious harm is outside the ordinary, requiring extraordinary care, or having lasting consequences.  The Board further noted that the ALJ stated that a serious injury may require hospitalization, or result in long-term impairment, or cause severe pain, as opposed to harm, injury, or impairment that is temporary, easily reversible with ordinary care, does not cause a period of incapacitation, heals without special medical intervention, or does not cause severe pain.  The Board did not endorse or adopt the ALJ’s definitional exercise but concluded that it was simply unnecessary in the context of that case.  The Board reasoned, as already noted, that the facility bore the burden to rebut the presumption by showing that the actual or threatened harm met no reasonable definition of serious.  Daughters of Miriam Ctr., DAB No. 2067 at 9-10.

Petitioner argues that the evidence does not show that the noncompliance caused or could have caused harm to a resident or that the noncompliance was likely to cause a resident, serious injury, harm, impairment, or death.  Petitioner argues it took precautions with Resident 1, it stopped all communal activities and dining, and it tested according to instructions of state and county health officials.  P. Br. at 24-25.  I have found no noncompliance based on Petitioner’s testing (Tag F886).  But contrary to Petitioner’s assertions, I have found that the evidence shows it was more likely than not that the Surveyor observed that communal activities and dining did occur in the secure unit on February 18, 2021, during the survey.

Petitioner has the burden to show that the declaration of immediate jeopardy was clearly erroneous, including the period of immediate jeopardy.  Petitioner has failed to meet its burden.  The evidence shows that Petitioner’s IPCP required the end of communal activities and dining; Petitioner’s director of nursing, administrator, and infection preventionists believed that communal dining and activities had ceased throughout the facility, and state health officials were so advised.  However, the evidence shows the Surveyor observed both communal activities and dining in the secure unit on February 18, 2021.  Therefore, Petitioner’s IPCP was not fully implemented on the secure unit, posing a risk that if COVID-19 did occur in the secure unit there was an increased risk for exposure to all residents in the secure.  The risk was higher on the secure unit as the evidence clearly shows that it was difficult to ensure that residents in the unit practiced social distancing and used a mask.  The evidence shows that it was well recognized at the time that COVID-19 posed a serious risk for harm or death particularly for residents in a long-term care facility.

Applying the clearly erroneous standard to the record before me related to the noncompliance based on the violation of 42 C.F.R. § 483.80, I have no definite and firm conviction that an error has been committed in the determination that immediate jeopardy existed and that it existed on February 18 and 19, 2021.  I have been cautious not to grant

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CMS double deference, i.e., application of the clearly erroneous standard is what is required with no additional deference granted.  I have carefully evaluated Petitioner’s evidence and arguments and do not “rubber stamp” the CMS determination that there was immediate jeopardy.  Accordingly, I conclude Petitioner has not met its burden to show that the determination of immediate jeopardy or its duration were clearly erroneous.

9. A reasonable enforcement remedy in this case is $ 6,808 per day for February 18 and 19, 2021, and $217.50 per day from February 20 through March 29, 2021 (38 days), for a total CMP of $19,440; roughly one-half the CMP proposed by CMS.

There is no evidence in the record of how CMS determined that a CMP of $11,175 for February 18 and 19, 2021, and $435 per day from February 20 through March 29, 2021, a total CMP of $38,880, was a reasonable enforcement remedy.  CMS is not required to place in evidence how it determined the appropriate enforcement remedy.  42 C.F.R. § 488.408(g)(2).  What is known is that when CMS determined the CMP in this case, it considered that there were two allegations of noncompliance that posed immediate jeopardy.  Arguably, one might conclude that one half of the CMP proposed by CMS was reasonable because I have concluded that there is only one instance of noncompliance not two.  However, I may not determine the reasonable enforcement remedy on that basis but must consider specified regulatory factors.

I have concluded that Petitioner violated 42 C.F.R. § 483.80 and the violation posed a risk for more than minimal harm to Petitioner’s residents.  I have also concluded that Petitioner has failed to show that the declaration of immediate jeopardy for the period February 18 and 19, 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).

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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; 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.

In determining whether the amount of a CMP is reasonable, the following factors specified at 42 C.F.R. § 488.438(f) must be considered:  (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, and the absence of culpability is not a mitigating factor.  The factors that CMS and 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 set forth in 42 C.F.R. § 488.404(b):  (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.

Based on my consideration of the regulatory factors, I conclude that the CMP imposed by CMS is not reasonable.  I declined to admit evidence CMS did not properly offer regarding Petitioner’s history of noncompliance prior to the survey at issue.  Thus, I have no evidence of a history of noncompliance to consider.  Petitioner does not argue that its financial condition affects its ability to pay the proposed CMP.  Petitioner’s noncompliance was serious because it posed immediate jeopardy for residents in Petitioner’s secure unit.  Petitioner was culpable.  Petitioner’s management failed to adequately supervise implementation of its IPCP resulting in communal activities and dining occurring in the secure unit on February 18, 2021.  Petitioner presented testimony of its director of nursing, administrator, and infection preventionists that all communal activities and dining had been stopped.  P. Ex. 14 at 2 ¶ 6; P. Ex. 15 at 4 ¶ 12; P. Ex. 16 at 2 ¶ 12; P. Ex. 23 at 2 ¶ 4.  Their testimony did not rebut the Surveyor’s observations of communal activities and dining in the secure unit on February 18, 2021.  Their testimony established that they were not aware that communal activities and dining did occur in the

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secure unit.  Their failure posed a risk for immediate jeopardy for all residents of the secure unit who were at increased risk due to their known inability to comply with social distancing and masking.

Petitioner argues there was no noncompliance, and therefore no enforcement remedy is reasonable.  Petitioner argues that if there was noncompliance, it did not pose immediate jeopardy.  Petitioner argues that it was a five-star facility, and its history of compliance should be considered.  Petitioner also argues that it avoided any COVID-19 infection in the secure unit after April 2020 and that should be considered evidence of the great job it did to protect residents.  P. Br. at 26; P. Reply at 11.  I have found there was noncompliance that posed immediate jeopardy.  The fact that Petitioner was a five-star facility with a good record of compliance are not factors listed in the regulations that I may consider.  However, I have not considered any history of noncompliance adverse to Petitioner.  I acknowledge that Petitioner’s staff made an excellent effort at infection control based on the fact the evidence shows limited outbreaks of COVID-19 and none in the secure unit after April 2020.  Petitioner’s effective implementation of its IPCP in most every respect is considered as reducing Petitioner’s culpability.

Based on my consideration of the regulatory factors and the evidence, I conclude that a reasonable CMP is $ 6,808 per day for February 18 and 19, 2021, and $217.50 per day from February 20 through March 29, 2021 (38 days), a total CMP of $21,881.  The $6,808 per day CMP for February 18 and 19, 2021 day is the lowest per day CMP authorized for noncompliance that poses immediate jeopardy.  The $ 217.50 per day CMP, half that proposed by CMS, is near the bottom of the lower range of CMPs ($112 per day to $6,695 per day) authorized for noncompliance that does not pose immediate jeopardy.  42 C.F.R. § 488.438(a)(1)(i), (d)(2); 45 C.F.R. § 102.3 (Table) (2020).

III.  Conclusion

For the foregoing reasons, I conclude that Petitioner was not insubstantial compliance with program participation requirements from February 18 through March 29, 2021, based on a violation of 42 C.F.R. § 483.80 that posed immediate jeopardy.  A reasonable enforcement remedy is a per day CMP of $6,808 for February 18 and 19, 2021, reduced to $217.50 per day from February 20 through March 29, 2021 (38 days), a total CMP of $21,881.