Sierra View Homes, DAB CR6469 (2024)

DECISION

Petitioner, Sierra View Homes, was not in substantial compliance with program participation requirements from July 3 through October 6, 2020. Petitioner was not in substantial compliance due to a violation of 42 C.F.R. § 483.80¹ that posed a risk for more than minimal harm.

There is a basis for the imposition of enforcement remedies. A civil money penalty (CMP) of $10,710 per day for the period of July 3 through 6, 2020, reduced to $112 per day from July 7 through October 6, 2020, is a reasonable enforcement remedy. A denial of payments for new admissions (DPNA) from August 7 through October 6, 2020, is also reasonable.

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I. Background

Petitioner is a skilled nursing facility (SNF) participating in the Medicare program. Petitioner is in Reedley, California. Surveyors from the California Department of Public Health, Licensing and Certification Program (state agency) completed a COVID-19 focused infection control survey of Petitioner on July 7, 2020. The surveyors concluded, and CMS alleges, that Petitioner was not in substantial compliance with Medicare participation requirements based on two regulatory violations that posed a risk of more than minimal harm to Petitioner’s residents, including one that was alleged to have posed immediate jeopardy from July 3 through 6, 2020. Joint Statement of Issues Presented, Joint Stipulation of Undisputed Facts, and Joint Statement of Settlement Status (Jt. Stip.) ¶¶ II.1-4; Centers for Medicare & Medicaid Services (CMS) Exhibit (Ex.) 1.

On August 21, 2020, CMS notified Petitioner of its initial determination to accept the survey findings and conclusions of the state agency and to impose a discretionary DPNA effective August 7, 2020; a CMP of $10,710 per day from July 3 through 6, 2020; and a CMP of $110 per day beginning July 7, 2020 and continuing until the facility achieved substantial compliance with program participation requirements. CMS also informed Petitioner that its provider agreement would be terminated effective January 7, 2021, and a mandatory DPNA would be imposed effective October 7, 2020, if Petitioner did not return to substantial compliance with program participation requirements before those dates. CMS Ex. 3 at 2; Jt. Stip. ¶¶ II.5-6; Hearing Transcript (Tr.) 11-14. The parties stipulate that the facility returned to substantial compliance effective October 7, 2020. Jt. Stip. ¶ II.7; CMS Ex. 5.

Petitioner timely requested a hearing before an administrative law judge (ALJ) on October 20, 2020 (RFH). On March 22 through 24, 2022, a hearing was convened by video teleconference, and a transcript was prepared. CMS offered CMS Exs. 1 through 55. CMS Exs. 1 through 35, 37, 39, 41 through 52, 54, and 55 were admitted as evidence.² Tr. 35-49. Petitioner offered P. Exs. 1 through 29, which were admitted as

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evidence.³ Tr. 50-60. CMS called the following witnesses: Surveyor Suren Ovanisyan, RN, and Surveyor Jehva Martinez, RN. Petitioner called the following witnesses: Vito Genna, Petitioner’s Associate Executive Director; Barbara Alatorre, RN, Petitioner’s Director of Nursing (DON); Janet Habegger, MD, Petitioner’s Medical Director; Joyce Gregory, RN, Petitioner’s Infection Preventionist; and Bernardo Reyes, MD.

The parties filed post-hearing briefs on July 5, 2022 (CMS Br. and P. Br., respectively) and post-hearing replies on August 8, 2022 (CMS Reply and P. Reply, respectively).

II. Substantive and Procedural Law

A. 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) and 42 C.F.R. pt. 483. Section 1819(h)(2) of the Act authorizes the Secretary (the Secretary) of Health and Human Services (HHS) to impose enforcement remedies against a SNF for failure to comply substantially with the federal participation requirements established by sections 1819(b), (c), and (d) of the Act.⁴ The Act requires that the Secretary terminate the Medicare participation of any SNF that does not return to substantial compliance with participation requirements within six months of being found not to be in substantial compliance. Act § 1819(h)(2)(C). The Act also requires that the Secretary deny payment of Medicare benefits for any beneficiary admitted to a SNF, if the SNF fails to return to substantial compliance with program participation requirements within three months of being found not to be in substantial compliance – commonly referred to as the mandatory or statutory DPNA. Act § 1819(h)(2)(D). The Act grants the Secretary discretionary authority to terminate a noncompliant SNF’s participation in Medicare, even if there has been less than six months of noncompliance. The Act also grants the Secretary authority to impose other enforcement remedies, including a discretionary DPNA, CMPs, appointment of temporary management, and a directed plan of correction. Act § 1819(h)(2)(B).

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The Secretary has delegated to CMS and the states the authority to impose remedies against a SNF or NF that is not in substantial compliance with federal participation requirements. 42 C.F.R. §§ 488.400, 488.402(b). “Substantial compliance means a level of compliance with the requirements of participation such that any identified deficiencies pose no greater risk to resident health or safety than the potential for causing minimal harm.” 42 C.F.R. § 488.301 (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. 42 C.F.R. § 488.301. The term “noncompliance” refers to any deficiency (statutory or regulatory violation) that causes a facility not to be in substantial compliance, that is, a deficiency that poses a risk for more than minimal harm. 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.

State survey agencies survey facilities that participate in Medicare on behalf of CMS to determine whether the facilities are complying with federal participation requirements. 42 C.F.R. §§ 488.10 .28, 488.300-.335. The regulations specify the enforcement remedies that CMS may impose if a facility is not in substantial compliance with Medicare requirements. 42 C.F.R. § 488.406.

CMS is authorized to impose a CMP against a facility not in substantial compliance with program participation requirements. 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.⁵ 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 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) (CMP amounts effective January 17, 2020).

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The Act and regulations make a hearing before an ALJ available to a long-term care facility against which CMS has determined to impose an enforcement remedy. Act §§1128A(c)(2), 1866(h); 42C.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.” 42C.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. 42C.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 nurse aide training and competency evaluation program (NATCEP). 42C.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.” 42C.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 42C.F.R. §488.438(e).

B. 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).

Under the de novo review standard, the ALJ addresses whether the evidence as it is developed before the ALJ supports the finding of noncompliance, not how CMS, or the facility, evaluated the evidence as it stood at whatever times CMS or the facility made their assessments.

Id.

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.⁶ 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

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establish a fact or raise a presumption unless disproved or rebutted.” Black’s Law Dictionary 1228 (8th ed. 2004). One might conclude that if the 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 should be required to present evidence sufficient to establish a disputed fact as more likely true than not and to raise a presumption, subject to being disproved or rebutted. The Board has never specifically ruled that to make a prima facie showing CMS must prove disputed facts by a preponderance of the evidence presented by CMS. Other decisions by various appellate panels of the Board, strongly suggest that whether CMS makes a prima facie showing as to disputed facts with evidence it presents is not really an issue, at least once a petitioner presents some evidence, because the Board’s position is that an ALJ must consider all the evidence of record to determine whether a prima facie case of noncompliance is shown. The Board has also suggested that CMS might satisfy its initial burden by presenting any relevant evidence even if it amounts to little more than mere allegations or a scintilla of evidence. In its decision in Hillman, following remand, the Board commented:

[I]f a party fails to establish a prima facie case, the opposing party may prevail without producing any evidence. However, it does not follow that, once the opponent has presented evidence, the decision-maker can ignore probative evidence properly in the record before him in weighing whether each party has proven an issue by the preponderance of the evidence.

Hillman Rehab. Ctr., DAB No. 1663 (1998 WL 479289 at 5).

One may interpret the Board’s statement to indicate that CMS needs to make its prima facie showing by a preponderance of the evidence. However, even if that was the Board’s position in Hillman, the Board also indicates that once a petitioner presents evidence, the issue of whether CMS has made a prima facie showing is of no consequence if the opponent’s evidence shows noncompliance. In St. Joseph Villa Nursing Ctr., DAB No. 2210 (2008), the Board cited its reasoning from Hillman and stated that “the legal sufficiency of CMS’s case does not depend solely upon the evidence submitted by CMS itself.” DAB No. 2210 at 3. Therefore, it is possible given the Board’s reasoning, that CMS might not present sufficient evidence to establish a prima facie case of noncompliance, but the petitioner’s evidence could cure the defect.⁷ One

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might thus conclude that CMS need not present any evidence, or CMS may present mere allegations or a scintilla of evidence, and the burden of persuasion would nevertheless be upon a petitioner to prove it was in substantial compliance.

In this case, I conclude CMS made a prima facie showing of noncompliance with the participation requirement of 42C.F.R. §483.80 (Tag F880) that has not been rebutted by Petitioner by a preponderance of the evidence. However, I conclude that the preponderance of the evidence in the whole record shows no violation of 42C.F.R. §483.45 and no noncompliance with that participation requirement.

C. Issues

Whether there is a basis for the imposition of enforcement remedies;

Whether the declaration of immediate jeopardy was clearly erroneous; and

Whether the remedies proposed by CMS are reasonable.

III. Discussion

A. The Allegations of Noncompliance at Issue

The findings and conclusions of the surveyors for the focused infection control survey completed on July 7, 2020, are recorded in a statement of deficiencies (SOD). The SOD gave Petitioner notice of the alleged noncompliance and the copy in evidence includes Petitioner’s plan for correcting the noncompliance. CMS Ex. 1.

The surveyors alleged noncompliance with the conditions of participation established by 42C.F.R. §483.45(g) and (h)(1) and (2) (Tag F761⁸ at scope and severity E⁹) (CMS Ex.

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1 at 2-5) and 42 C.F.R. § 483.80(a)(1), (2), (4), (e), and (f) (Tag F880 at scope and severity L) (CMS Ex. 1 at 5-25). CMS notified Petitioner by its August 21, 2020 initial determination that CMS imposed enforcement remedies, including a CMP and a discretionary DPNA, based on the allegations of noncompliance from the SOD. CMS Ex. 3. Therefore, all the alleged noncompliance from the SOD is before me for consideration. I find and conclude that there was noncompliance under Tag F880, which is addressed first in this decision, followed by discussion of Tag F761, for which I conclude that the preponderance of the evidence in the whole record shows no noncompliance with the participation requirement established by 42 C.F.R. § 483.45.

Under Tag F880, the surveyors alleged a violation of 42 C.F.R. § 483.80 subsections (a)(1), (a)(2), (a)(4), (e), and (f). Only 42 C.F.R. § 483.80 and subsections (a) and (f) of

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the regulation are at issue in this case. The general overarching requirement of 42C.F.R. §483.80 is that Petitioner must “establish” and “maintain” an infection prevention and control program (IPCP) with the goals of providing its residents “a safe, sanitary, and comfortable environment” that helps “prevent the development and transmission of communicable diseases and infections.” 42C.F.R. §483.80. The regulation requires implicitly that Petitioner implement, i.e., follow, its IPCP to accomplish the objectives specified by the regulation. Golden Living Ctr. – Superior, DAB No. 2768 at 7 (2017). The requirements of 42C.F.R. §483.80(a) are that Petitioner establish an IPCP with the four elements specified in the regulation. In this case, there is no dispute that Petitioner had the required IPCP with all four elements. Pursuant to 42C.F.R. §483.80(f), Petitioner is required to review its IPCP annually and to update its IPCP as necessary, but there is no allegation in the SOD that Petitioner failed to conduct an annual review of its IPCP and update it as necessary. CMS Ex. 1 at 5-25. The handling, storing, processing, and transporting of linens to prevent spreading infection is covered by 42C.F.R. §483.80(e), but that subsection is not at issue as there are no allegations in the SOD regarding the handling storing, processing, and transporting of linen. CMS Ex. 1 at 5-25. Therefore, the issue in this case is whether Petitioner implemented its IPCP as required by 42C.F.R. §483.80.

The surveyors allege that Petitioner “failed to implement and maintain a safe environment with an effective” IPCP. CMS Ex. 1 at 7. The surveyors cite four examples in support of their conclusion that there was noncompliance under Tag F880. Improper screening of staff and failure to disinfect a thermometer were cited as the first and fourth examples. The second and third examples are based, in part, on failure to implement Petitioner’s IPCP which required that Petitioner adequately train staff on signs and symptoms of COVID-19 infection and what staff were to do if signs and symptoms were experienced. The surveyors allege that due to Petitioner’s failure to implement its IPCP, three certified nurse assistants (CNAs) provided resident care while experiencing signs and symptoms of COVID 19. CMS Ex. 1 at 7-8. In this case, noncompliance under Tag F880 is established by the facts that two CNAs delivered resident care while experiencing signs and symptoms of COVID-19, in violation of the requirements of Petitioner’s IPCP. There is no need to consider the other examples alleged by the surveyors under Tag F880, as the one example is sufficient to show that noncompliance occurred.

B. Findings of Fact, Conclusions of Law, and Analysis

My conclusions of law are set forth in bold text followed by 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

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evidence given the greatest weight in my decision-making.¹⁰ 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., Administrative Law & Practice §5:64 (3d ed. 2013).

1. Petitioner was not in substantial compliance from July 3 through October 6, 2020, due to a violation of 42C.F.R. §483.80 that posed a risk for more than minimal harm.

a. Facts

National Standards

Pursuant to 42C.F.R. §483.80(a)(1), Petitioner’s IPCP must follow accepted national standards. The evidence before me includes evidence of accepted national standards related to COVID-19.

Petitioner placed in evidence a California Department of Public Health (CDPH) issued All Facilities Letter (AFL), AFL 20-17, dated March 3, 2020. AFL 20-17 indicates that it provides facilities new and updated COVID-19 guidance from the Centers for Disease Control and Prevention (CDC). AFL 20-17 is not a regulation issued by the CDPH, but according to its terms it provided guidance. Nevertheless, AFL 20-17 is evidence of the state and national health care standard for dealing with COVID-19. AFL 20-17 states that California healthcare facilities should comply with the CDC’s “Interim Guidance for Healthcare Facilities: preparing for Community Transmission of COVID-19 in the United States.” AFL 20-17 indicates that the CDC guidance is that staff should be made aware of facility sick leave policies, and that they should stay home if they are ill with respiratory symptoms. P. Ex. 4 at 1.

CDPH’s AFL 20-25.1 dated March 20, 2020, was addressed to skilled nursing facilities specifically. AFL 20-25.1 indicated that facility healthcare staff should be instructed to not report to work if symptomatic with fever or respiratory symptoms, and to report their

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symptoms to their supervisor. Healthcare staff were to be instructed that if they developed respiratory signs and symptoms at work they were to immediately stop work, put on a face mask, inform their supervisor, leave the facility, and self-isolate at home. P.Ex. 7 at 2. An attachment to AFL 20-25.2 dated April 15, 2020, includes similar guidance for healthcare staff in skilled nursing facilities. P. Ex. 9 at 1-2.

CDPH guidance is consistent with guidance from the CDC published in “Preparing for COVID-19: Long-term Care Facilities, Nursing Homes,” from March 21, 2020. The CDC recommended that healthcare staff not report to work when ill and if they have signs or symptoms of respiratory infection while at work they should immediately put on a mask, inform their supervisor, and leave the workplace. P. Ex. 12 at 3. Subsequent CDC guidance updated June 25, 2020 titled “Preparing for COVID-19 in Nursing Homes” was that healthcare staff should be told that if they develop a fever of greater than or equal to 100 degrees Fahrenheit, or symptoms consistent with COVID-19 while at work they should inform their supervisor and leave the workplace. P. Ex. 13 at 3-4; CMS Ex. 41 at 3-4. The changes in the CDC guidance were that staff were to report COVID-19 like symptoms rather than respiratory symptoms and it was not specified that they should immediately don a mask.

On May 6, 2020, the CMS Center for Clinical Standards and Quality/Quality, Safety & Oversight Group issued QSO-20-29-NH. Attached to the CMS guidance is a checklist to be used by surveyors when conducting an infection focused survey of a long-term care facility. Section 6 of the checklist relates to education, monitoring, and screening of staff. Surveyors were required to check if the facility trained staff that if they developed signs or symptoms of illness, including COVID-19, at work they were to don a facemask and be sent home.¹¹ P. Ex. 15 at 12. In the frequently asked questions attachment CMS described respiratory symptoms consistent with COVID-19 as shortness of breath, difficulty breathing, new or change in cough, sore throat, or new loss of taste or smell. P. Ex. 15 at 19. The fact Petitioner placed this document in evidence shows that Petitioner had the document but not when it was received.

The CDC issued a document titled “Symptoms of Coronavirus” that was updated May 13, 2020, that listed the following, nonexclusive list, of symptoms of COVID-19 infection: fever or chills; cough; shortness of breath or difficulty breathing; fatigue;

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muscle or body aches; headache; new loss of taste or smell; sore throat; congestion or runny nose; nausea or vomiting and diarrhea. CMS Ex. 42 at 1.

Petitioner presented several articles discussing studies related to COVID-19 symptoms, particularly loss of taste and smell. P. Exs. 24 through 28; Tr. 643-50. It is not necessary to discuss the articles in detail in this decision. One article involved a survey of prior studies and the authors concluded that most signs and symptoms studied had poor diagnostic accuracy. However, loss of taste and smell, fever, or cough may be red flags for COVID-19. P. Ex. 24 at 7. A study of patients in Wuhan, China does not list loss of taste or smell as a sign or symptom observed in 41 laboratory confirmed COVID-19 patients. P. Ex. 25. A report of the study of self-reported loss of smell by 86 COVID-19 patients concluded that a significant portion of the 86 in the study did not have loss of smell on objective testing. P. Ex. 26 at 1-2. An article indicates that since the COVID-19 pandemic was declared the loss of smell was quickly accepted as a sign of COVID-19 infection. P. Ex. 27 at 1. The researchers followed 97 patients some for up to a year and found that most recovered their sense of smell. P. Ex. 27 at 3. The study does not address whether loss of smell was a good or bad diagnostic criteria for COVID-19 infection but does appear to attribute the loss of smell in those followed to the infection. P. Ex. 27 at 3. A report based on a study of 711 patients in Germany, some of whom tested positive for COVID-19 and some of whom did not, indicates that the reported loss of taste or smell as a sign or symptom of COVID-19 infection required more investigation. P. Ex. 28 at 1. I find that this scientific evidence does not resolve whether the loss of taste or smell is a good or a bad diagnostic indicator of COVID-19 infection. The findings and conclusions reported are all entitled to little weight as each suffers from one or more weakness, including being based on subjective reports and/or a small sample size. I find that these studies do not detract from the CDC guidance that loss of taste or smell may be an indicator of COVID-19 infection. CMS Ex. 42 at 1; P. Ex. 15 at 19. Petitioner’s expert witness, Bernardo Reyes, MD, testified that the 11 signs or symptoms identified by the CDC are nonspecific indicators for COVID-19 infection because they may be signs and symptoms of many other illnesses. He also testified that asymptomatic transmission may have also been a significant factor in the pandemic, even though that was not really recognized until later. Tr. 640-41, 648-49, 663-66, 673-74. Dr. Reyes’ testimony was credible, and his opinions entitled to weight. The articles presented by Petitioner also are entitled to weight. However, Dr. Reyes’ testimony and the articles do not rebut or negate the evidence discussed hereafter that Petitioner accepted CDC guidance as evidence of the national standard for infection and disease prevention and control, as well as guidance from other sources including CMS, the CDPH, and the county health department. More importantly, the evidence discussed hereafter shows that Petitioner’s policy before COVID was that staff who were sick were to stay home and if staff became sick at work, they were to inform their supervisor and go home and that policy was not changed by COVID-19. Petitioner’s reliance on individual staff to recognize they were sick and avoid spreading infections or diseases to residents was a

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significant element of Petitioner’s IPCP. The evidence shows it was part of Petitioner’s IPCP to ensure staff were knowledgeable of the signs and symptoms of infection and disease. Training, including formal and informal training on CDC guidance, was provided for that purpose.

The evidence shows that, prior to the survey in this case, the CDPH, the CDC, and CMS were advising long-term care and other facilities and surveyors, that COVID-19 infection posed a risk for serious harm or death to long-term care facility residents. CMS Exs. 41, 42, and 47 and P. Exs. 3 through 19.

Petitioner's IPCP

Petitioner’s IPCP, including specific policies and procedures related to COVID-19, and Petitioner’s COVID-19 mitigation plan addendum are in evidence. CMS Ex. 44.

Petitioner’s IPCP states that it is “established and maintained to provide a safe, sanitary and comfortable environment and to help prevent the development and transmission of communicable diseases and infections.” CMS Ex. 44 at 14. Petitioner’s IPCP provides that it is reviewed annually and updated as necessary. Petitioner’s IPCP also states that it is based on national standards. CMS Ex. 44 at 14. These statements are consistent with the requirements of 42C.F.R. §483.80. Petitioner’s IPCP specifically refers to guidelines of the CDC. CMS Ex. 44 at 16. Interventions for the prevention of infections include “educating staff and ensuring that they adhere to proper techniques and procedures.” CMS Ex. 44 at 16. Monitoring employee health and safety is also covered by Petitioner’s IPCP, stating that Petitioner has adopted policies and procedures covering situations when staff and others should report infections or avoid being at the facility. CMS Ex. 44 at 16. Petitioner explained in its IPCP that it established policies and procedures regarding infection control for “employees, contractors, vendors, visitors, and volunteers” and those “individuals should report their infections or avoid the facility” if they have “draining skin wounds, active respiratory infections with considerable coughing and sneezing, or frequent diarrheal stools....” CMS Ex. 44 at 16.

Petitioner’s “Coronavirus Preparation and Response, and Mitigation,” revised on May 27, 2020, sets forth the steps Petitioner was taking to prevent COVID-19 in its facility and to respond to COVID-19 infection if it occurred. CMS Ex. 44 at 3. Petitioner states that COVID-19 “induces flu like symptoms and may lead to acute respiratory illness.” CMS Ex. 44 at 3. Petitioner’s policy also states that the clinical presentation of COVID-19, includes fever, cough, and shortness of breath. The policy indicates that the clinical course of COVID-19 may lead to severe and potentially fatal illness with greatest risk for residents of advanced age and/or residents who are immunocompromised. CMS Ex. 44 at 3. There is no dispute that Petitioner understood COVID-19 was highly communicable, there was no accepted antiviral treatment, and no vaccine, and only

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implementation of its IPCP provided a measure of protection for residents and staff. CMS Ex. 44 at 3. Petitioner specifically directed all staff to comply with procedures adopted for maximum infection prevention and control. CMS Ex. 44 at 3. Section 4 of the procedure addressed managing ill and exposed healthcare staff. Petitioner stated that it refers to CDC guidance regarding active monitoring and work restrictions of healthcare staff. Section 6 of the procedure required that staff be trained to recognize signs and symptoms of COVID-19 but did not specifically refer to the CDC guidance on signs and symptoms discussed above. CMS Ex. 44 at 6. However, I infer that Petitioner intended to follow CDC guidance, including the guidance on signs and symptoms, based on the statements in Petitioner’s IPCP indicating it followed CDC guidance (CMS Ex. 44 at 16).

Petitioner’s IPCP included a “COVID-19 Outbreak Plan” dated May 11, 2020, that did not provide instructions for staff on what to do in the event they had possible COVID-19 symptoms while at work. CMS Ex. 44 at 12-13.

Petitioner also placed in evidence its Coronavirus Pandemic Disaster Drill, which was presented during in-service trainings of staff held in March 2020. P. Ex. 23 at 10- 25; Tr. 557-58. The objectives of the training included, among others, “know what steps to take if residents or staff may suspect exposure to coronavirus.” P. Ex. 23 at 16. The training instructed staff to stay home when sick except to obtain medical care. P. Ex. 23 at 17. The training documents listed symptoms for COVID-19 including fever of 100.4 degrees Fahrenheit and above, cough, shortness of breath, and close contact (within six feet for 10 minutes or more) with someone who has confirmed COVID-19 within the last two to 14 days.¹² P. Ex. 23 at 17. Staff were instructed that if they had possible COVID-19 symptoms they were to:

• Notify their supervisor;
• Call their healthcare provider for further instructions; and
• Stay at home and have their physician send verification to Petitioner by facsimile.
• If staff became ill with possible COVID-19 symptoms while at work, staff were instructed to obtain a mask right away, check their temperature,

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and report to their supervisor. Staff were told that if they became ill at work, they should be sent home as soon as possible.

P. Ex. 23 at 16-17.

The facility’s DON, Barbara Alatorre, testified at the hearing that Petitioner had an IPCP before COVID-19 reached the United States in early 2020. DON Alatorre testified that it was Petitioner’s policy prior to COVID-19 that staff should stay home if they were not feeling well. Tr. 425, 460. She testified that she was highly involved with the IPCP as DON working closely with the infection preventionist. Tr.402-03. She testified that Petitioner’s IPCP was based on national standards for prevention and control. She testified that when she learned about COVID-19 spreading she started ordering as much personal protective equipment as possible and she and the infection preventionist started training staff. They were looking at information from the World Health Organization (WHO), the White House, the CDPH, the CDC, and CMS to decide the best ways to keep residents and staff safe. Petitioner’s medical director was also involved in reviewing and updating the IPCP to cover changes in guidance from the various organizations. Tr. 404-11, 422-23. She testified that questions staff were asked when they entered Petitioner for work were whether they had shortness of breath, cough, or fever. Tr. 416. CMS Ex. 49 consists of records of staff screenings that were obtained by the surveyors. A screening form used in Petitioner’s assisted living facility with entries from June and July 2020, required staff to enter their temperature and state whether they had a cough. CMS Ex. 49 at 1-4; Tr. 417. The screening form used in Petitioner’s SNF, with entries dated in June and July 2020, had different screening questions. The form required that staff enter their temperature on the form and answer whether they had a cough, a sore throat, shortness of breath, and whether they had been exposed to someone with COVID-19 symptoms or who had tested positive. DON Alatorre testified that the entries were made from June 2 through July 7, 2020. CMS Ex. 49 at 5-21; Tr. 418-21.¹³ DON Alatorre testified that the CDC’s “Preparing for COVID-19: Long-term Care Facilities, Nursing Homes” (P. Ex.

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12) was the guidance she thought they were to follow in July 2020, as it was addressed specifically to long-term care facilities. Tr. 434. It is stated on the first page of the CDC guidance that fever, cough, and shortness of breath are symptoms of respiratory infection which includes COVID-19. P. Ex. 12 at 1. A section of the CDC guidance that addressed staff with symptoms of respiratory illness recommended that a healthcare staff member who developed fever or symptoms of respiratory infection, i.e., cough or shortness of breath, at work should immediately put on a facemask, inform the supervisor, and leave the workplace. P. Ex. 12 at 3. DON Alatorre testified that Petitioner did not update its staff screening form based on the more detailed signs or symptoms identified by the CDC in its May 13, 2020 “Symptoms of Coronavirus” (CMS Ex. 42at 1). Tr. 433-34, 448. DON Alatorre suggested that the CDC’s list of symptoms focused on the elderly but the document simply states “[p]eople with COVID-19 have had a wide range of symptoms reported ....” The CDC does not specify that only the elderly reported the symptoms listed. CMS Ex. 42at 1. DON Alatorre’s interpretation of the CDC guidance listing symptoms is not credible considering the plain language of CMS Ex. 42. I do not accept her testimony as weighty evidence that Petitioner was not using the CDC’s list of signs and symptoms of COVID-19 from May 2020 (CMS Ex. 42at 1; P. Ex. 15 at 19) in training staff of the signs and symptoms to be watchful for, at least in residents, which should have also caused staff to be alert for similar signs and symptoms that they had. DON Alatorre’s testimony on cross-examination supports an inference staff were being trained to watch for all symptoms on the CDC list, but with the suggestion that some of the symptoms were more likely to occur in the elderly residents. DON Alatorre testified that she did not know when the longer list of symptoms began appearing on staff sign-in sheets. Tr. 449, 452-55, 477-78. Except as noted, DON Alatorre’s testimony was fully credible.

COVID-19 was discussed at Petitioner’s April 22, 2020 Quality Assurance Performance Improvement (QAPI) committee meeting. Minutes of the meeting show that Petitioner continued to educate staff on how to spot symptoms and what to do if concerned. P. Ex. 29 at 2.

Petitioner’s medical director, Janet Habegger, MD, testified that Petitioner followed infection control guidance from the CDC, the federal guidelines, and state guidance. Tr.492. Staff were screened for fever, cough, and shortness of brief. Staff members were told that if they felt sick, whether it felt like a common cold, the flu, or something else, they were supposed to say something and not come in the facility. She understood from CDC guidance that fever, cough, and shortness of breath were the primary symptoms, but the longer CDC list of signs and symptoms included associated or secondary symptoms. She believed that all Petitioner’s staff were probably aware of all the signs and symptoms listed by the CDC. She knew that the lists were available and there was staff training. She opined that failure to add loss of taste or smell to the staff screening list posed no risk for significant harm. Tr. 493-99. Staff were not told that the

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longer list of CDC symptoms, i.e., the secondary or associated symptoms, applied only to residents. Tr. 514-16. Dr. Habegger’s testimony was fully credible.

Petitioner’s associate executive director (administrator), Vito Genna, testified that staff were told to stay home if they felt sick. Tr. 340.

Joyce Gregory, RN, Petitioner’s infection preventionist and director of staff development, testified she worked at Petitioner for 24 years. Tr. 545-46. She testified that in October 2019, Petitioner adopted a new IPCP (CMS Ex. 44 at 14) developed in coordination with a consultant. Tr. 547-48. She testified that when the COVID-19 outbreak began in China, she started monitoring the WHO, the CDC, CMS, the CDPH, the county health department, the governor’s office, and the White House for information. Information was shared with all staff. Tr. 549-51. RN Gregory testified that it was extremely difficult in May and June 2020, to keep up with all the different guidance being issued. She testified it became impractical to continue formal in-service trainings given all the work staff was doing. But she worked to ensure all staff was informed of changes as they occurred. Tr. 563-64. She testified that any staff member suspected of being contagious would be asked to leave the facility. Tr. 592. She testified that she recalled giving training on the CDC list of 11 signs or symptoms of COVID-19. Tr. 595-600. She testified that beginning in June 2020, if staff had any symptoms of COVID-19, they had to put on a mask, they were tested, and told to leave the building. Tr. 601. RN Gregory’s testimony was fully credible.

I find based on the preponderance of the evidence that Petitioner’s healthcare staff should have known based on training and information available to them that new loss of taste or smell was a sign or symptom of possible COVID-19 infection, though staff may have been under the impression that new loss of smell or taste was more likely a sign or symptom in the elderly.

Staff with Symptoms

The surveyors alleged in the SOD that one example showing Petitioner violated 42C.F.R. §483.80 (Tag F880) was that Petitioner’s staff did not know what steps to follow when signs or symptoms of COVID-19 developed while they were working at Petitioner. CMS Ex. 1 at 7. The surveyors identified three CNAs in the SOD who had possible symptoms of COVID-19 but continued to work at Petitioner. The surveyors allege that:

CNA 12, Fatima Aguilera (F. Aguilera), was interviewed by surveyors by telephone on July 3, 2020. CMS Ex. 1 at 18; CMS Ex. 2 at 4. CNA Aguilera told surveyors that she worked the 2:15 p.m. to 10:45 p.m. shift on June 25, 2020. During her lunch break on June 25, 2020, she experienced loss of taste and smell,

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she did not recognize that as a possible symptom of COVID-19, and she continued providing resident care that day. She tested positive for COVID-19 on June 27 or 28, 2020. CMS Ex. 1 at 18-19.

CNA 13, Danayara Diaz, was interviewed by telephone on July 3, 2020. CMS Ex. 1 at 19; CMS Ex. 2 at 4. CNA Diaz worked on June 25, 2020, from 2:15 p.m. to 10:45p.m. She told surveyors that during her lunch break on June 25, 2020, she experienced loss of taste and smell. She was unaware that loss of taste and smell might be a sign or symptom of COVID-19. She thought she might have a cold. She continued to provide care to residents after lunch on June 25, 2020. She tested positive for COVID-19 on June 27, 2020. CMS Ex. 1 at 19-20.

CNA 3, Bertha Aguilera (B. Aguilera), was interviewed by telephone on July 3, 2020. CMS Ex. 1 at 20; CMS Ex. 2 at 3. CNA Aguilera told surveyors that she worked on June 25, 2020, from 2:15 p.m. to 10:45p.m. She had a headache but thought nothing of it and continued working with residents throughout her shift. She tested positive for COVID-19 on June 28, 2020. CMS Ex. 1 at 20.

Surveyor Suren Ovanisyan, RN, testified that he participated in the survey of Petitioner with Susan Agnello, RN. Tr. 86. Surveyor Ovanisyan testified about his interviews with CNA F. Aguilera and CNA Diaz consistent with the report of those interviews in the SOD. He did not ask the CNAs why they were tested for COVID-19 if they did not think they had symptoms. Tr. 120-32, 193-05. On cross-examination he agreed that his surveyor notes showed that CNA Diaz told him she was told that loss of taste or smell could be a symptom of COVID-19 and she shared that with CNA F. Aguilera. However, both CNAs went back to work and completed their shift. Surveyor Ovanisyan also agreed on cross-examination that if the two CNAs had gone home, they would not have violated Petitioner’s IPCP. Tr. 201-05. Surveyor Ovanisyan’s testimony was fully credible. Surveyor Ovanisyan did not testify regarding the interview with B. Aguilera, possibly because that interview was conducted by Surveyor Agnello, who CMS could not produce to testify. Tr. 21-22, 121-22. The example of B. Aguilera is not considered further.

CMS has submitted payroll documentation indicating that CNA Diaz and CNA F. Aguilera continued to work through the end of their shifts on June 25, 2020. CMS Ex. 48 at 1-2; CMS Ex. 50 at 3-4; Tr. 126.

Regarding the allegations that CNA F. Aguilera and CNA Diaz experienced loss of taste or smell and discussed that during their lunch break on June 25, 2020, DON Alatorre testified:

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THE WITNESS: I never heard about that until it came out later that they had this discussion amongst themselves, and actually, the one girl turned up to work the next day, and so we tested her, but she thought, ah, it’s just -- they thought maybe they’re just -- you know, they were just having conversation at their 7 o'clock break and, hey, I kind of feel like that too, but Dayanara (ph.) [CNA Diaz] actually came to work the next day, because she thought she felt fine and things resolved, but when we tested her, you know, we took her off, so she was sent home that next day.

JUDGE SICKENDICK: So the next day, when she told the management, or whomever, she told the nurse or whatever, that’s when she was sent home, right?

THE WITNESS: The next day when she came into work, I’m not even sure if she said those symptoms, she just didn’t quite feel herself, and so she was tested.

JUDGE SICKENDICK: Yes. Okay. Yes, it’s hard for me to understand how staff could have been aware that those were potential symptoms of COVID and then they did not act on that, and --

THE WITNESS: Yeah.

JUDGE SICKENDICK: You don’t have an explanation for that, I take it.

THE WITNESS: I don’t, sir, and they never, they never expressed that to the nurses on duty that night, like, we’re having these symptoms, we need to go home, so the first we heard about it was when it came out with the survey.

Tr. 450-51. DON Alatorre did not deny the incident occurred or that both the CNAs involved tested positive for COVID-19.

Petitioner’s medical director, Dr. Habegger, also testified regarding the two CNAs who lost their taste and smell, discussed that fact during their lunch break, but failed to report and continued working their shift. The CNAs were subsequently not permitted to return to work. She testified they reported their symptoms on June 25, 2020, and they were tested on June 27 and 28, 2020. She believed that the CNAs were tested using a rapid

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test with positive results the same day. Tr. 502-04. She testified that staff were trained in June 2020 and before, that if they felt sick while at work, they were to put on a mask, inform their supervisor, and they would be sent home. Tr. 522-23.

b. Analysis

Petitioner is required by 42C.F.R. §483.80 to establish and maintain an IPCP. The Board has held that the “establish and maintain” language of 42C.F.R. §483.80 means that a facility must have an IPCP and it must implement the IPCP by following the program adopted. Golden Living Ctr. – Superior, DAB No. 2768 at 7; Heritage House of Marshall Health & Rehab. Ctr., DAB No. 2566 at 12 (2014); The Windsor House, DAB No. 1942at 12 (2004); Park Manor Nursing Home, DAB No. 2005 at 60 (2005). The regulation requires that Petitioner’s IPCP be “designed to provide a safe, sanitary, and comfortable environment and to help prevent the development and transmission of communicable diseases and infections.” 42C.F.R. §483.80. Petitioner’s IPCP must establish a system based on accepted national standards for “preventing, identifying, reporting, investigating, and controlling infections and communicable diseases for all residents, staff, volunteers, visitors, and other individuals providing services” at Petitioner. 42C.F.R. §483.80(a)(1). Evidence of standards from the CDC, CMS, and the CDPH has been discussed as part of my findings of fact in this case. The Secretary and CMS do not dictate the national standards applicable.¹⁴ CMS specifically decided not to incorporate CDC guidelines by reference in the infection control regulation at 42C.F.R. §483.80, stating:

Act § 1801 (42 U.S.C. § 1395).

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

81 Fed. Reg. 68,688, 68,808 (Oct. 4, 2016). CDC guidelines do not have the force and effect of law because they are not promulgated as regulations. Cf. Azar v. Allina Health Servs., 588 U.S. __, 139 S. Ct. 1804 (2019). Rather, CDC guidelines are evidence of a standard of practice that CMS has found acceptable. CMS gives long-term care facilities significant discretion to determine how to best address infections within the facility consistent with national standards. The standards Petitioner adopted in its IPCP were not inconsistent with the standards recommended by the CDC, CMS, and the CDPH.

The evidence shows that Petitioner had an IPCP. Petitioner’s witnesses and Petitioner’s IPCP show that Petitioner’s IPCP included two rules that are particularly important in this case:

If staff felt ill or sick, they were to stay home, and

If staff felt ill or sick at work, they were let their supervisor know, and go home.

P. Br. at 13-15; P. Reply at 3, 6-7, 11. The evidence shows that these important infection control rules existed as part of Petitioner’s IPCP, before COVID-19 became an issue in early 2020. These two rules applied whether the staff member affected knew the cause of the sick or ill feeling. Whether a cold, the flu, or bad fish, the two rules applied equally. The evidence of standards from the CDC, CMS, and the CDPH are entirely consistent with and support the two rules. The evidence of training of Petitioner’s staff in the record before me shows that staff were trained to follow the two simple rules.

The violation of 42C.F.R. §483.80 occurred in this case because, contrary to Petitioner’s IPCP, CNA F. Aguilera and CNA Diaz, continued to work on June 25, 2020, even though during their meal break, they discussed that they both felt ill. The fact that they felt ill, or even not as well as usual, should have been sufficient to trigger recollection of their training and the requirement to report to their manager and go home. Whether their failure was due to inadequate training, inexperience, or some other cause cannot be and need not be determined. Petitioner had adopted the two simple rules as part of its IPCP.

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The two CNAs were unable or unwilling to recognize and apply the rules. Whether the CNAs were experiencing symptoms of COVID-19 or some other disease or infection, does not affect their duty to report that they felt unwell to their supervisor or manager. Whether the CNAs were experiencing symptoms of a cold, the flu, or COVID-19, Petitioner’s simple policy shows that Petitioner recognized that the risk for any disease placed residents at risk for more than minimal harm.

Petitioner does not dispute that its IPCP required staff to “leave the workplace immediately if feeling ill.” P. Br. at 13-15; P. Reply at 3, 6-7, 11, 15. Petitioner concedes that both CNAs “thought they had cold or flu symptoms and continued to work the rest of the day in violation of clearly articulated [facility] policy,” and that the CNAs “were told they had COVID symptoms.” P. Br. at 13-15 P. Reply at 6-7. According to Petitioner, the CNAs’ decision to work with residents after becoming aware they were ill was not due to any failing on the part of Petitioner’s training program. P. Br. at 15. Petitioner takes the position that the CNAs “chose to ignore [the facility’s] policy to leave if they had symptoms of any illness.” P. Br. at 15. Indeed, Petitioner emphasizes that “staff clearly knew that they were required to remain home if they felt ill, and if feeling ill when on the job, to report any symptoms and go home immediately.” P. Reply at 11. Petitioner argues that the examples of the two CNAs do not show that there was a systemic failure of Petitioner’s IPCP. P. Reply at 11. Petitioner offers no explanation for what is or is not a systemic failure or point to any requirement in the Act or 42C.F.R. pt. 483 that establishes a requirement that there be a systemic failure for there to be noncompliance. Granted, “systemic failure” is found in many decisions issued by the Board. However, systemic failure of a facility’s IPCP is not a condition that must be found to conclude a facility failed to implement its IPCP. The evidence shows that Petitioner accepted early in the COVID-19 pandemic that the risk for a resident was for more than minimal harm, and likely serious harm or death. The violation of Petitioner’s IPCP posed a risk that a resident would be infected by exposure to one of the CNAs. Violation of the participation requirement and a risk for more than minimal harm are all that are required for there to be noncompliance that supports the imposition of an enforcement remedy. Even if some requirement for a systemic failure is found, the evidence in this case shows that Petitioner had an IPCP, a system for the prevention of disease and infection; that system failed when two CNAs did not go home when they felt ill; and there was, therefore, a systemic failure.

Petitioner arguments may also be interpreted to be that the two CNAs knew better than to continue to work, but they failed to follow the rules for their own reasons. However, Petitioner cannot avoid responsibility for the actions of its staff. The Board has repeatedly explained that “for the purpose of evaluating a facility’s compliance with the Medicare and Medicaid participation requirements, the facility acts through its staff and cannot dissociate itself from the consequences of its employees’ actions.” Springhill Senior Residence, DAB No. 2513 (2013); Cherrywood Nursing & Living Ctr., DAB No.

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1845at 14 (2002); Ridge Terrace, DAB No. 1834. The CNAs may have been derelict in their responsibilities by not reporting they had possible symptoms of illness and then going home. However, Petitioner remains responsible for the CNAs’ actions. Whether the CNAs specifically intended to violate Petitioner’s IPCP is not material, because their motive does not matter. The Board has explained that a “facility whose administration and staff have been found not to be substantially complying with federal requirements is itself subject to administrative enforcement remedies” and “cannot avoid such remedies merely by attempting to disown the acts and omissions of its own staff and administration since the facility elected to rely on them to carry out its commitments.” Beverly Health Care Lumberton, DAB Ruling No. 2008-5 at 6-7 (2008) (emphasis added); Kindred Transitional Care and Rehab – Greenfield, DAB No. 2792 at 11-15 (2017).

2. Petitioner has not met its burden to show that the declaration of immediate jeopardy for the period of July 3 through 6, 2020, based on the noncompliance with 42C.F.R. §483.80 (Tag F880), was clearly erroneous.

The surveyors determined that the noncompliance under Tag F880 posed immediate jeopardy beginning July 3, 2020. The surveyors determined that the immediate jeopardy was abated on July 7, 2020. CMS Ex. 1 at 1-2. Petitioner bears a heavy burden to show that the determination that the noncompliance under 42C.F.R. §483.80 posed immediate jeopardy from July 3 through 6, 2020, was clearly erroneous.

Immediate jeopardy is defined as “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.” 42C.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. 42C.F.R. §§488.408(e), 488.438(a)(1)(i), (c), and (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. 42C.F.R. §§488.410, 488.440(g), 488.456, 489.53(d)(2)(B)(ii).

Pursuant to 42C.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

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to review. 42C.F.R. §§488.408(g), 498.3(b)(8) and (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. 42C.F.R. §498.3(b)(14) and (16).

The determination of immediate jeopardy must be upheld, unless Petitioner shows the declaration of immediate jeopardy was clearly erroneous. 42C.F.R. §498.60(c)(2). 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 and 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., 174F. 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 that 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.”¹⁵ 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. 42C.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

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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 objectively measured boundaries.” 59Fed. 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 November10, 1994, the drafters of 42C.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

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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 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 42C.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., 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 passage from Mississippi Care Ctr. that panel of the Board states that the clearly erroneous standard means that “the 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 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

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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. at 371-72; Concrete Pipe, 508U.S. at 622. The “substantial evidence” standard considers whether a reasonable mind might accept a particular evidentiary record as adequate to support a conclusion. Consol. Edison, 305 U.S. at 229; Dickinson, 527U.S. at 162. 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. at 395; Dickinson, 527 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.¹⁶ 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 and 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 42C.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 and Rehab./Goldsboro, 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

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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 42C.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., DAB No. 2422 at 8, that the regulations do not define or explain the meaning of the term “serious” as used in the definition of immediate jeopardy. 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 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.

Applying the clearly erroneous standard to the record before me related to the noncompliance I have found based on the violation of 42C.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 from July 3 through July 6, 2020. The evidence shows that, despite recognizing that they had loss of taste and smell and, thinking that they had cold or flu like symptoms or they were ill for some other reason, two CNAs remained in the facility and continued to provide care to residents on June 25, 2020, instead of going home, as required by the Petitioner’s IPCP.

The evidence shows that, prior to the survey in this case, the CDPH, the CDC, and CMS were advising long-term care and other facilities and surveyors, that COVID-19 infection posed a risk for serious harm or death to long-term care facility residents. CMS Exs. 41, 42, and 47 and P. Exs. 3 through 19. Petitioner’s “Coronavirus Preparation and Response, and Mitigation,” revised on May 27, 2020, which is part of Petitioner’s IPCP shows that Petitioner accepted as fact that the clinical course of COVID-19 could lead to

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severe and potentially fatal illness with greatest risk for residents of advanced age and/or residents who were immunocompromised. CMS Ex. 44 at 3. There is no dispute that Petitioner understood COVID-19 was highly communicable, there was no accepted antiviral treatment, and no vaccine, and only implementation of its IPCP provided a measure of protection for residents and staff. CMS Ex. 44 at 3. Therefore, Petitioner’s argument that the CNAs’ violation of Petitioner’s policy that sick or ill staff were to report to their supervisor and be sent home did not pose immediate jeopardy, i.e., a probable risk for serious harm or death to its elderly residents, is not persuasive. CNA F. Aguilera was tested for COVID-19 on June 27, 2020, and reported to be positive for COVID-19 infection on June 28, 2020. CNA Diaz was tested on June 26, 2020, and reported to be positive on June 27, 2020. CMS Ex. 35 at 1-3. The fact that both CNAs tested positive for COVID-19 within days of feeling ill but continued to serve residents on June 25, 2020, further rebuts Petitioner’s arguments that there was no immediate jeopardy. The confirmed COVID-19 infection of the CNAs within a couple of days of their treating residents, supports my conclusion that the declaration of immediate jeopardy was not clearly erroneous. Petitioner’s medical director and expert witness did not opine to the contrary.

I conclude that Petitioner has not shown that the declaration of immediate jeopardy based on the noncompliance cited under 42C.F.R. §483.80 was clearly erroneous.

3. Petitioner did not violate 42 C.F.R. §483.45(h) (Tag F761).

The SOD alleges that Petitioner violated 42C.F.R. §483.45(g) and (h) (Tag F761) and that the violation posed the potential for more than minimal harm. CMS Ex. 1 at 2. Rules for labeling drugs and biologicals are established by 42C.F.R. §483.45(g). No facts are alleged by the SOD showing any violation of 42C.F.R. §483.45(g) and that regulation is not considered further. The noncompliance alleged by the SOD is related to the storage of drugs and biologicals which is governed by 42C.F.R. §483.45(h), and that regulation is considered.

a. Facts

Surveyor Jehva Martinez, RN, was called to testify by CMS. Tr. 253-55. She participated in the survey of Petitioner and was at Petitioner on July 3 and 4, 2020. She was not involved in the declaration of immediate jeopardy. Tr. 258-60. She testified that she toured Petitioner’s COVID-19 unit on July 4, 2020. Tr. 260. She observed that a nurse station had been established in Petitioner’s former special needs room. In the nurse station area, she observed a cart that she was told was used for medications. She described the cart as having shelves that were opened on all four sides. She observed that on the cart there were baskets with individually packaged medications for the residents of the COVID-19 unit. She testified she was concerned that the medications were not in a

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locked medication room or medication cart. She noted that the nurse in the area was preparing documents, but she could not recall if she asked if the nurse was getting ready to deliver the medications to the eight residents on the COVID-19 unit. She observed that there was a cabinet in the room that she was told could be locked. When she looked in the cabinet, it was empty, but she noted plumbing for the sink installed in the top of the cabinet. She verified that the medications on the cart were for the eight residents on the COVID-19 unit. She testified that she was told that the utility cart was being used for medications and the medications were not stored anywhere else. Surveyor Martinez testified that she asked and was told that there were no Schedule II medications on the cart. Tr. 264-69, 299. She testified that the nurse told her that only nurses and CNAs working in the COVID-19 unit had access to the room, no housekeeping or maintenance staff were entering the COVID-19 unit. Residents on the COVID-19 unit were confined to their rooms. She testified that when she arrived the door to the room was unlocked but she did not recall asking if it was normally unlocked. Tr. 272-74. Surveyor Martinez testified that she was accompanied by Surveyor Agnello. After observing the nurse’s station, they left the COVID-19 unit and went to speak to the DON who was in an area separated from the COVID-19 unit by a plastic barrier. Surveyor Martinez asked DON Alatorre about the use of the medication cart. The DON called for the nurse in the COVID-19 area to approach the barrier so they could speak. Surveyor Martinez testified that DON Alatorre asked the nurse where she was keeping the medication and the nurse responded that the medication was kept on the medication cart. Surveyor Martinez testified that DON Alatorre then told the nurse the medications should be stored in the cabinet with the lock under the sink. Surveyor Martinez testified she suggested that the DON call the pharmacy for a medication cart because she was concerned about the medication becoming compromised under the sink if there was leak. Tr- 269-72. She recalled that Surveyor Agnello told her that Petitioner’s pharmacy delivered a medication cart the next day. Tr. 274. She testified that the nurse in the COVID-19 unit and the DON did not say that use of the open utility cart for medication was only temporary. Tr. 275. She did not recall asking how Petitioner intended to secure the medication that was on the utility cart. Tr. 276. She did not ask whether the medications on the cart were secured under the sink when the nurse on the COVID-19 unit came to the plastic barrier to speak with the DON. She believed that the CNA on the unit was tending to residents while the nurse came to the barrier, though she did not explain how she knew that. Tr. 277. In response to my questions, she testified that she concluded the nurse left the medications on the utility cart unattended when the DON called her to approach the barrier to speak. Tr. 286. On cross-examination she explained that she saw the cart when she entered the nurse work area, and a nurse was present. She testified that it was close to lunch when it is common to pass medication to residents. She testified that the door to the nurse area was unlocked but a nurse was present. Tr. 289-91. She admitted on cross-examination that during the period when she and Surveyor Agnello left the COVID-19 area and found the DON, she did not know what was going on in the nurse area in the COVID-19 unit. She agreed she could not see from where she was with the DON

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whether the medication cart was unattended. She assumed based on the verbal exchange that the medication cart was left unattended, but she did not ask that question. She also did not ask the nurse in the COVID-19 unit whether she had locked up the medications. Tr. 296-97, 309-10. Surveyor Martinez’s testimony is credible. However, I find that Surveyor Martinez never observed the medication on the cart unattended or not properly secured. When she and Surveyor Agnello were in the nurse’s station area, a nurse was present. When Surveyor Martinez was outside the nurse’s station with DON Alatorre, she could not see if the medications were on the cart, if the medications had been secured in the locked cabinet, or if another staff member was present with the medications. Her finding that the medication was unsecured – the surveyor’s predicate fact for the conclusion that there was noncompliance – was speculation.

DON Alatorre testified that a medication cart without a lock was being used at the time of the July survey. She explained that when Petitioner opened the quarantine area a third medication cart was ordered but the pharmacy did not have an extra cart that could be used by Petitioner at the time. However, the quarantine area had a cabinet that could be locked with a padlock. There were only eight residents in the quarantine area so she obtained eight baskets into which she placed each resident’s medication and the baskets were locked in the cabinet with the padlock. The charge nurse had the key to the padlock. The charge nurse only removed medication from the cabinet that was needed to do a medication pass. The charge nurse had to use a stainless-steel cart to carry the medications on as she went room-to-room. Tr. 441-42. The pharmacy did provide a cart quickly and storing medication in the cabinet with the padlock did not last very long. Tr. 465. In response to my questions, DON Alatorre testified that Petitioner’s first COVID-19 positive resident was identified on June 27, 2020. During the night of June 27, 2020, Petitioner installed the plastic barrier to segregate the COVID-19 positive area. It was also during the night of June 27, 2020, that medication for COVID-19 positive residents was moved to the area. The open utility cart observed by the surveyors was also moved to the area that night and the decision was made to lock the medication in the cabinet under the sink in the nurse’s area until a proper medication cart could be obtained. Tr. 469-72. DON Alatorre’s testimony is credible and unrebutted.

Petitioner’s medication storage policy, which is not alleged to have been inadequate, required that medications to be “stored safely, securely, and properly, following manufacturer’s recommendations or those of the supplier.” CMS Ex. 55 at 1. The policy further provided that “[o]nly licensed nurses, pharmacy personnel, and those lawfully authorized to administer medications such as medication aides are allowed access to medications” and that “[m]edication rooms, carts, and medication supplies are locked or attended by persons with authorized access.” CMS Ex. 55 at 1. The policy required that medications be stored in a medication cart or other designated area. CMS Ex. 55 at 1-2. Petitioner had a separate policy that required more secure storage of scheduled medications. CMS Ex. 55 at 4-5. Locking up medications when not being distributed

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during a medication pass under the supervision of one authorized to access and pass the medication, is required by Petitioner’s policy. Petitioner’s use of the utility cart to pass non-scheduled medications in the COVID-19 positive area and locking the medication at other times under the sink in the nurse’s area, was not inconsistent with Petitioner’s medication storage policy.

Petitioner’s “COVID-19 Outbreak Plan” dated May 11, 2020, recognized that that it may be necessary to rent another medication cart for narcotics to use in the COVID isolation unit. CMS Ex. 44 at 13.

b. Analysis

The SOD alleges that Petitioner failed to store medications in locked compartments for eight residents in the COVID-19 unit and medications were stored on an open utility cart not equipped with drawers or locks. The SOD does not allege that any Schedule II drugs or other drugs subject to abuse were involved, only that there were physician prescribed and over the counter medications on an open utility cart. CMS Ex. 1 at 3.

The requirements for the storage of drugs and biologicals are established by 42C.F.R. §483.45(h), which provides:

(1) In accordance with State and Federal laws, the facility must store all drugs and biologicals in locked compartments under proper temperature controls, and permit only authorized personnel to have access to the keys.

(2) The facility must provide separately locked, permanently affixed compartments for storage of controlled drugs listed in Schedule II of the Comprehensive Drug Abuse Prevention and Control Act of 1976 and other drugs subject to abuse, except when the facility uses single unit package drug distribution systems in which the quantity stored is minimal and a missing dose can be readily detected.

42C.F.R. §483.45(h). The testimony of Surveyor Martinez shows that there were no Schedule II drugs involved and she did not identify any drugs subject to abuse. Tr. 267, 299. Therefore, the focus of the alleged noncompliance is 42C.F.R. §483.45(h)(1).

SOM Tag F761 provides that medications other than Schedule II through V medications or those subject to abuse, must be in a locked storage area with access limited to authorized personnel. “Storage areas may include, but are not limited to, drawers, cabinets, medication rooms, refrigerators, and carts.” P. Ex. 2 at 3. Schedule II through

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V drugs must be in separately locked, permanently affixed compartments with an access system separate from that used to obtain non-scheduled medications. The SOM provides that during a medication pass, the medications must be under direct observation of the person who is administering the medications, or the medications must be locked in the medication storage area or the medication cart. P. Ex. 2 at 3.

Surveyor Martinez testified that when she observed the medications on the open cart, a nurse was present. Tr. 265-66, 269. She did not recall asking the nurse if she was getting ready for a medication pass. Tr. 267. However, she subsequently testified that her observation was at about lunch time when a medication pass would normally occur. Tr. 289-91. She did observe that there was a cabinet in the nurse’s area with a sink on top and plumbing underneath and that she was told could be locked. Tr. 267-68. Surveyor Martinez indicated that the door to the room where the medication cart was located could also be locked. Tr. 265, 291-92. She admitted that when she and Surveyor Agnello went to find DON Alatorre they left the area where the medication cart had been. She also admitted that she did not know whether the nurse she had seen in the area locked-up the medication she had seen on the cart when the nurse came to speak with her and DON Alatorre. Tr. 296-97, 309-10.

I conclude based on all the evidence of record, that the preponderance of the evidence shows no violation of 42C.F.R. §483.45(h). The evidence does not show that the medication in the COVID-19 positive area was left on the medication cart unattended and not locked-up in either the room or under the sink. Surveyor Martinez admitted she did not know but assumed the medication was left unattended and unsecured. DON Alatorre testified that the medication was to be locked up under the sink in the nurse’s area when the medication was not being passed to residents. DON Alatorre’s testimony is unrebutted.

4. A CMP of $10,710 per day from July 3 through July 6, 2020, is reasonable.

5. A CMP of $112 per day, the lowest permissible per day CMP, from July 7 through October 6, 2020, is reasonable.

6. There is a basis for the imposition of a discretionary DPNA from August 7 through October 6, 2020.

CMS advised Petitioner by letter dated August 21, 2020, that it was imposing a discretionary DPNA effective August 7, 2020; a CMP of $10,710 per day from July 3 through 6, 2020; and a CMP of $110 per day beginning July 7, 2020, and continuing until the facility achieved substantial compliance with program participation requirements. CMS Ex. 3 at 2; Jt. Stip. ¶¶II.5-6; Tr. 11-14. The parties stipulate that the facility

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returned to substantial compliance effective October 7, 2020. Jt. Stip. ¶II.7; CMS Ex. 5. A CMP of $110 per day was not an authorized CMP under the regulations in effect at the time of the survey or the CMS initial determination. If CMS elects to impose a CMP in the lower range as it has in this case, it is required to impose a CMP within the authorized range, which at the time was $112 to $6,695 per day. 42C.F.R. §488.438(a)(1)(ii); 45C.F.R. §102.3 (Table) (2020) (listing authorized CMP amounts effective January 17, 2020). Accordingly, I conclude that a CMP of $110 per day (the minimum authorized in 2019) may not be approved. A per day CMP of $112 is the minimum that may be approved in this case considering that the survey was conducted in July 2020 and the CMS initial determination was issued on August 21, 2020. I am required to follow the Act and regulations. 1866ICPayday.com, L.L.C., DAB No. 2289 at 14 (2009). Therefore, the remedies at issue in this case are:

A per day CMP of $10,710 for July 3, 4, 5, and 6, 2020, reduced to $112 per day for July 7 through October 6, 2020; and

A discretionary DPNA from August 7 through October 6, 2020.

I have concluded that Petitioner violated 42C.F.R. §483.80 (Tag F880) and that the violation was noncompliance because it 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 that noncompliance from July 3 through July 6, 2020, was clearly erroneous. The noncompliance under 42C.F.R. §483.80 (Tag F880) is a basis for the imposition of an enforcement remedy, including a CMP. 42C.F.R. §§488.400, 488.430. A CMP in the higher range is required for immediate jeopardy. 42C.F.R. §488.438(a)(1).

I have concluded that Petitioner did not violate 42C.F.R. §483.45(h). No enforcement remedy is authorized based on the alleged noncompliance under 42C.F.R. §483.45(h) (Tag F761).

There are some well-established rules and principles related to the review of enforcement remedies, particularly CMPs. The Board has stated that the fact CMPs are included among authorized remedies for noncompliance shows that the Secretary has already determined that CMPs serve a remedial purpose and the Board is bound by that determination. ALJs and the Board review whether a CMP amount is reasonable under the regulatory factors listed in 42C.F.R. §§488.404(b) and 488.438(f), and can change the amount if they find it is not reasonable based on the factors. However, ALJs and the Board cannot eliminate the CMP or reduce the CMP to zero under 42C.F.R. §488.438(e)(1). Liberty Commons Nursing & Rehab. – Alamance, DAB No. 2070 at 18 (2007), aff’d, Liberty Commons Nursing v. Leavitt, 285 F. App’x 37 (4th Cir. 2008). The Secretary has specified by regulation that CMS’s choice of sanctions to impose, including

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whether a CMP is to be imposed per day or per instance, is not subject to review. 42C.F.R. §§488.408(g)(2), 488.438(e)(2), 498.3(d)(11).

When a facility is not in substantial compliance with program requirements, CMS has the authority to impose one or more of the enforcement remedies listed in 42C.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 substantial compliance or a per instance CMP for each instance that a facility is not in substantial compliance. 42C.F.R. §488.430(a). If CMS elects to impose enforcement remedies, CMS must follow the criteria of 42C.F.R. §488.408(c)(2), (d)(2), and (e)(2) when selecting the remedies to impose. 42C.F.R. §488.409(b). 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. 42C.F.R. §§488.408(c), (d), (e), 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. 42C.F.R. §§488.408(e)(1)(iii), 488.438(a)(1)(i), (d)(2); 45C.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. 42C.F.R. §§488.408(d)(1)(iii), 488.438(a)(1)(ii); 45C.F.R. §102.3 (Table) (2020).

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 by CMS is a CMP, my authority to review the reasonableness of the CMP is limited by 42C.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 42C.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 42C.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 42C.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. 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 42C.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

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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.

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 CMP amount to impose, but my authority is limited by regulation as already explained. I am to determine whether the amount of any CMP proposed is within reasonable bounds, considering the purpose of the Act and regulations. Liberty Commons Nursing – Alamance, DAB No. 2070; 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).

Petitioner has not argued that it is unable to pay the proposed CMP. The evidence shows that Petitioner was cited for noncompliance by surveys in January 2019, November 2018, and November 21, 2019. The survey in January 2019, included a citation of noncompliance under Tag F880. The noncompliance cited by all three surveys was cited as posing a risk for more than minimal harm with no actual harm. The evidence does not show that CMS imposed any enforcement remedy for any citation of noncompliance by the three surveys. The evidence shows that Petitioner had returned to substantial compliance on February 27, 2020. CMS Ex. 4. I do not find that Petitioner’s history of noncompliance weighs heavily in the determination of a reasonable CMP. However, Petitioner’s noncompliance with the infection control requirement at 42C.F.R. §483.80 was very serious and posed immediate jeopardy for all of Petitioner’s residents. The CDC, CMS, the CDPH, and Petitioner all recognized early in the COVID-19 pandemic in 2020 that COVID-19 posed a risk for serious harm or death to long-term care facility residents and extraordinary techniques had to be employed to keep them safe. The CDC’s guidance, “Preparing for COVID-19: Long-Term Care Facilities, Nursing Homes,” dated March 21, 2020, stated the following regarding the threat of COVID-19 to nursing home populations:

Given their congregate nature and residents served (e.g., older adults often with underlying chronic medical conditions), nursing home populations are at the highest risk of being affected by COVID-19. If infected with SARS-CoV-2, the virus that causes COVID-19, residents are at increased risk of serious illness.... [I]ll visitors and healthcare personnel (HCP) are the most likely sources of introduction of COVID-19 into a facility. CDC recommends aggressive visitor restrictions and enforcing sick leave policies for ill HCP, even before COVID-19 is identified in a community or facility.

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P. Ex. 12 at 2.

The facility also recognized that COVID-19 posed a significant threat to long term care facility residents:

People with higher risks are more likely to exhibit severe symptoms that at times are even fatal. Risks include those older than 65 years of age and persons with chronic illnesses such as immunocompromised, severe obesity, chronic kidney disease undergoing dialysis, serious heart conditions, chronic lung disease and diabetes. Residents of a long-term care facility often suffer from these problems as well as share close living spaces. The virus is transmissible through droplet, airborne and through contact with contaminated surfaces.

Experience with COVID-19 in skilled nursing facilities shows that the virus can spread rather rapidly and extensively.

CMS Ex. 44 at 12. The facility specifically recognized that the virus is “highly communicable” and that, at that time, COVID-19 “is spreading world-wide and is of concern to the well-being of our residents because of their age and co-morbidities.” CMS Ex. 44 at 3.

Even though new guidance was being issued frequently by the CDC, CMS, and the CDPH, Petitioner had adopted a simple rule that sick staff were to stay home or go home. Petitioner was culpable because two CNAs failed to follow Petitioner’s simple rule, which was an important part of Petitioner’s IPCP even before the COVID-19 pandemic began. Petitioner’s management and supervisors bore the heavy burden to ensure that staff who were ill or sick did not spread COVID-19 or any other illness to residents or other staff. Whether anyone contracted COVID-19 from the two CNAs is not shown by the evidence, but it is the violation of Petitioner’s IPCP that weighs heavily.

The evidence shows that Petitioner’s management and staff did many things right to protect its residents from COVID-19. This result may seem harsh considering Petitioner’s efforts. However, a fundamental part of Petitioner’s COVID-19 response was to segregate the sick. The simple rule that staff were to stay home if sick or go home if sick was no doubt as effective as masking or distancing. The simple rule was violated. Whether any resident contracted COVID-19 from the two CNAs is not material. Petitioner failed to ensure staff complied strictly with the simple rule; Petitioner’s IPCP was violated; and so also was 42CFR §483.80.

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CMS imposed a CMP of $10,710 per day from July 3 through July 6, 2020, based on the existence of immediate jeopardy level noncompliance. CMS Ex. 3 at 2. The $10,710 per day CMP is in the lower half of the upper range of CMPs authorized when there is immediate jeopardy – $6,808 per day to $22,320 per day. 42C.F.R. §§488.408(e)(1)(iii), 488.438(a)(1)(i), (d)(2); 45C.F.R. §102.3 (Table) (2020). Based on my consideration of the regulatory factors the per day CMP of $10,710 for the period beginning July 3, 2020, when immediate jeopardy was declared (CMS Ex. 1 at 1) through July 6, 2020, the day before the immediate jeopardy was abated (CMS Ex. 1 at 2), is reasonable.

The surveyors state in the SOD that after the IJ was abated on July 7, 2020, they determined that the scope and severity level for the noncompliance under Tag F880 remained “L”. CMS Ex. 1 at 1. However, once the immediate jeopardy was abated, the noncompliance could not have been characterized as a scope and severity of L, as a scope and severity L is defined as widespread immediate jeopardy by SOM §7400.3.1 - Matrix for Scope & Severity (rev. 185, eff. Nov. 16, 2018). The SOD does show that the surveyors concluded that noncompliance continued after the immediate jeopardy was abated, but their scope and severity determination was in error. CMS Ex. 1 at 1-2, 5-25. CMS did not correct this error in its August 21, 2020 initial determination. CMS Ex. 3. However, the CMS initial determination reflects that CMS determined noncompliance continued after immediate jeopardy was abated on July 7, 2020. I recognize that at the time of the initial determination CMS was also considering alleged noncompliance under Tag F761. I have found no noncompliance under Tag F761. However, the evidence shows that noncompliance was not corrected under Tag F880 (CMS Ex. 1 at 26-118) until Petitioner returned to substantial compliance on October 7, 2020 as stipulated by the parties (Jt. Stip. II.7). I consider the continuing noncompliance under Tag F880 to have been at a scope and severity of D, E, or F, in the absence of any evidence of actual harm. Further, because the lowest authorized per day CMP of $112 is imposed, that CMP amount is consistent with noncompliance that poses a risk for more than minimal harm without actual harm.

My conclusion that there was no noncompliance under Tag F761, would generally cause me to adjust the per day CMP downward. However, no such adjustment is possible in this case. The CMP in the higher range was only authorized based on the immediate jeopardy posed by the noncompliance under Tag F880. When immediate jeopardy was abated, CMS lowered the CMP below the minimum authorized amount for noncompliance that did not pose immediate jeopardy. As $112 per day is the lowest per day CMP that can be imposed for noncompliance that does not pose immediate jeopardy, I have no discretion to reduce the $112 per day CMP.

A discretionary DPNA is also an authorized enforcement remedy. 42C.F.R. §§488.406(a)(2), 488.417(a). I may not review the CMS determination to impose a

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DPNA. 42C.F.R. §488.408(g)(2). Because there was noncompliance for the period of July 3 through October 6, 2020, there was a basis for CMS to impose a discretionary DPNA and it is reasonable.

IV. Conclusion

For the foregoing reasons, I conclude that:

Petitioner violated 42C.F.R. §483.80 by failing to ensure its infection control policy was implemented and the violation posed immediate jeopardy.

There is a basis for the imposition of enforcement remedies.

A CMP of $10,710 per day for the period of July 3 through 6, 2020, and a CMP of $112 per day for the period of July 7 through October 6, 2020, is a reasonable enforcement remedy.

A discretionary DPNA from August 7 through October 6, 2020, is a reasonable enforcement remedy.

Endnotes

¹ References are to the 2019 revision of the Code of Federal Regulations (C.F.R.), unless otherwise indicated. Appellate panels of the Board have concluded it is appropriate in long-term care facility survey cases to apply the revision of the regulatory participation requirements in the C.F.R. in effect at the time a survey was conducted. Good Shepard Home for the Aged, Inc., DAB No. 2858 at 1 n.1 (2018); Carmel Convalescent Hosp., DAB No. 1584 at 2 n.2 (1996).

² Citations to CMS Ex. 47 refer to the “Corrected” copy submitted by CMS. Departmental Appeals Board Electronic Filing System (DAB E-File) Item # 15_d.CMS Exs. 36, 38, 40, and 53 were not admitted but CMS was granted leave to reoffer upon laying an adequate foundation. Tr. 39-42, 43-49. The exhibits were not reoffered by CMS.

³ P. Exs. 22, 24, 27, and 28 are all dated after the survey. However, Petitioner explained the exhibits were offered to show the bases for Petitioner’s expert witness testimony and they were admitted for that purpose. Tr. 50-60.

⁴ SNFs and NFs are often referred to as long-term care facilities or nursing homes. NF participation in Medicaid is governed by section 1919 of the Act. Section 1919(h)(2) of the Act gives enforcement authority to the states to ensure that NFs comply with their participation requirements established by sections 1919(b), (c), and (d) of the Act.

⁵ CMS annually adjusts CMP amounts that may be imposed to account for inflation in compliance with the Federal Civil Penalties Inflation Adjustment Improvements Act of 2015, Pub. L. No. 114-74, § 701, 129 Stat. 584, 599 (2015). 81 Fed. Reg. 61,538, 61,549 (Sept. 6, 2016).

⁶ Congress granted the Secretary authority to impose enforcement remedies for noncompliance. Act § 1819(h)(2). The Secretary is authorized to impose CMPs as an enforcement remedy by section 1128A of the Act. CMPs are imposed by CMS with delegated authority of the Secretary. 42 C.F.R. § 488.2. Pursuant to subsection 1128A(j) of the Act, section 205 of the Act is applicable to the imposition of CMPs, and that section is applicable to the imposition of CMPs by both the Secretary and the Commissioner of Social Security under the authority of section 1128A of the Act. The Inspectors General (IGs) for both HHS and the Social Security Administration (SSA) also exercise delegated authority to impose CMPs pursuant to section 1128A of the Act. Both IGs engaged in rulemaking to specify the allocation of the burden of persuasion and the quantum of evidence required when proceeding upon a case involving a CMP. Both the SSA IG and the HHS IG imposed upon the government in CMP cases the burden of persuasion on all issues other than affirmative defenses and mitigating factors for which the burden is upon the nongovernmental party. The regulations of the IGs for SSA and HHS provide that the burden of persuasion is to be judged by a preponderance of the evidence. 20 C.F.R. § 498.215(b), (c); 42 C.F.R. § 1005.15(b), (d). CMS failed to promulgate a regulation like those of the HHS and SSA IGs and the Board has filled the gap with its interpretative rules allocating the burden of persuasion to the nongovernmental party, the party defending against the imposition of the CMP.

⁷ Certainly, the petitioner has the option not to offer any evidence at the hearing in an attempt to avoid having its evidence considered in determining whether CMS made a prima facie showing of noncompliance. However, in cases subject to 42 C.F.R. pt. 498, the parties are generally required by the ALJ to exchange evidence well in advance of the hearing. Whether Petitioner’s evidence filed as part of an exchange, even if not admitted as evidence, might be treated by the Board as evidence going to support the CMS prima facie case is an open question.

⁸ This is a “Tag” designation as used in CMS Pub. 100-07, State Operations Manual (SOM), app. PP – Guidance to Surveyors for Long Term Care Facilities. The current SOM is available at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Internet-Only-Manuals-IOMs-Items/CMS1201984. Copies of Tag F761 and Tag F880 from the revision of the SOM in effect during the survey are in evidence as P. Ex. 2. The “Tag” refers to the specific regulatory provision allegedly violated and CMS’s policy guidance to surveyors. Although the SOM does not have the force and effect of law, the provisions of the Act and regulations interpreted clearly do have such force and effect. Ind. Dep’t of Pub. Welfare v. Sullivan, 934 F.2d 853 (7th Cir. 1991); Nw. Tissue Ctr. v. Shalala, 1 F.3d 522 (7th Cir. 1993). Thus, while the Secretary may not seek to enforce the provisions of the SOM, he may seek to enforce the provisions of the Act or regulations as interpreted by the SOM.

⁹ Scope and severity levels are used by CMS and a state when selecting remedies. The scope and severity level is designated by an alpha character, A through L, selected by CMS or the state agency from the scope and severity matrix published in the SOM, ch. 7, § 7400.3.1 (rev. 185, Nov. 16, 2018). A scope and severity level of A, B, or C indicates a deficiency that presents no actual harm but has the potential for minimal harm, which is an insufficient basis for imposing an enforcement remedy. Facilities with deficiencies of a level no greater than C remain in substantial compliance. 42 C.F.R. § 488.301. A scope and severity level of D, E, or F indicates a deficiency that presents no actual harm but has the potential for more than minimal harm that does not amount to immediate jeopardy. A scope and severity level of G, H, or I indicate a deficiency that involves actual harm that does not amount to immediate jeopardy. Scope and severity levels J, K, and L indicate deficiencies that constitute immediate jeopardy to resident health or safety. The matrix, which is based on 42 C.F.R. § 488.408, is used by CMS to determine which remedies are required and optional at each level based upon the frequency of the deficiency. SOM, ch. 7, § 7400.6 (rev. 63, Sep. 10, 2010).

¹⁰ “Credible evidence” is evidence that is worthy of belief. Black’s Law Dictionary 596 (8th ed. 2004). The “weight of evidence” is the persuasiveness of some evidence compared to other evidence. Id. at 1625.

¹¹ A subsequent checklist issued with QSO-20-38-NH on August 26, 2020, which was after the survey in this case, did not require surveyors to check if staff were trained that upon developing symptoms at work, they were to don a mask and be sent home. P. Ex. 18 at 19.

¹² I note that this list of symptoms was presented during the March 2020 trainings, prior to the CDC’s May 2020 issuance of its nonexclusive list of symptoms. CMS Ex. 42 at 1; P. Ex. 15 at 19.

¹³ There is in evidence a third screening form with entries dated July 6 and 7, 2020, that asks whether the person screened had a fever of 100.4 degrees Fahrenheit or above, cough, shortness of breath, difficulty breathing, chills, muscle pain, headache, vomiting, diarrhea, new loss of taste, and new loss of smell. The department or organization listed for some of the individuals screened are SNF and CNA. CMS Ex. 49 at 23-24. Petitioner’s infection preventionist, RN Joyce Gregory, explained that the sign-in forms marked CMS Ex. 49 at 23 and 24 were created based on the guidance of the surveyors as part of the plan of abatement of the immediate jeopardy. Tr. 575-76. Surveyor Suren Ovanisyan also testified that CMS Ex. 49 at 23 and 24 are copies of forms created after the surveyors declared there was immediate jeopardy. Tr. 106-09.

¹⁴ Congress has limited the authority of the Secretary and components of HHS, such as CMS and the CDC, to control the practice of medicine by dictating standards of care. Section 1801 of the Act provides:

Nothing in this title shall be construed to authorize any Federal officer or employee to exercise any supervision or control over the practice of medicine or the manner in which medical services are provided, or over the selection, tenure, or compensation of any officer or employee of any institution, agency, or person providing health services; or to exercise any supervision or control over the administration or operation of any such institution, agency, or person.

¹⁵ Decisions often cited include: Lakeport Skilled Nursing Ctr., DAB No. 2435 at 7 (2012); Liberty Health & Rehab of Indianola, LLC, DAB No. 2434 at 13, 18-19 (2011); Yakima Valley Sch., DAB No. 2422 at 8; Lutheran Home at Trinity Oaks, DAB No. 2111 (2007); Britthaven of Havelock, DAB No. 2078 (2007); Daughters of Miriam Ctr., DAB No. 2067 (2007); Koester Pavilion, DAB No. 1750; Woodstock Care Ctr., DAB No. 1726 at 39.

¹⁶ The Board’s characterization of the clearly erroneous standard as being highly deferential to the fact-finding by the state agency surveyor and CMS, and even triggering a rebuttable presumption, is entirely consistent with the Supreme Court’s characterization of the standard. However, the Court’s cautions about ensuring meaningful review rather than rubber-stamping agency decisions show it is important for the ALJ and the Board not to be tempted to simply defer to the surveyor, the state agency, or CMS on the immediate jeopardy issue.