Life Care Center of Kirkland, DAB CR5975 (2021)

DECISION

Petitioner violated 42 C.F.R. § 483.80(a)(1)1 beginning on February 26, 2020, by failing to ensure its infection control policy was implemented.  The violation continued until July 1, 2020.  The violation posed immediate jeopardy from February 26 through March 27, 2020.

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There is a basis for the imposition of enforcement remedies.  A civil money penalty (CMP) of $13,585 per day for the period February 26 through March 27, 2020, a total CMP of $421,135, is a reasonable enforcement remedy.  A denial of payments for new admissions (DPNA) from March 21 through 27, 2020, is also reasonable.

INTRODUCTION

This introduction is intended to provide the reader an overview.  This introduction does not set forth my finding of facts but is a summary based on the detailed findings set forth later.

In February 2020, Petitioner's staff noticed an increase in infections among residents.  Petitioner's infection control nurse and medical director became concerned about a cluster of unexplained fevers on one unit of the facility.  Petitioner's Exhibits (P. Exs.) 3 at 9, 38 at 1.  On February 26, 2020, Petitioner's infection control nurse notified the Seattle and King County Health Department (County Health Department) that Petitioner had a cluster of unusual fevers and respiratory infections.  P. Ex. 3 at 2, 9.  According to Petitioner, on February 26, 2020, Petitioner closed to visitors, informed families of the closure, closed the dining and therapy rooms, began providing meals and therapy only in resident rooms, cancelled all group activities, cancelled student nurse rotations, increased bleaching of all public areas including doorknobs, hall railings, and bathrooms, ordered additional personal protective equipment (PPE) , and trained staff on these measures and the use of PPE.  P. Ex. 3 at 9.

Although the County Health Department was called on February 26, 2020, a representative did not respond until the next day, February 27, 2020.  When the County Health Department representative was informed of all of Petitioner's interventions, the representative suggested that Petitioner start using disposable plates and forks, limit admissions, and use droplet precautions.  P. Exs. 3 at 9-10, 38 at 2.

Late on February 28 or early on February 29, 2020, Petitioner was notified that a hospitalized resident and a hospitalized staff member had both tested positive for COVID-19.2   Throughout the first week of March 2020, a number of Petitioner's

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residents would decline rapidly and had to be sent to the emergency rooms of local hospitals.  Many died at the hospital and some at Petitioner.  P. Ex. 3 at 3-4; P. Ex. 9.

Petitioner issued a press release on March 20, 2020, providing a public update on the situation at Petitioner.  Petitioner reported that it had 120 residents on February 19, 2020.  As of March 20, 2020, 66 residents had been transferred to hospitals; 57 were positive for COVID-19, seven were negative, two were not tested, and two who tested positive initially subsequently tested negative.  Between February 19 and March 20, 2020, 34 residents died; 23 died in the hospital, and 11 died at Petitioner.  Of those who died in the hospital, 21 tested positive for COVID-19 and one tested negative.  Of those who died at Petitioner, eight tested positive, one tested negative, and two were not tested.  Petitioner had 42 residents on March 20, 2020, 31 tested positive for COVID-19 and 11 tested negative.  Petitioner had approximately 180 staff on February 19, 2020.  From February 27 to 29, 2020, 48 members of Petitioner's staff were out sick.  Petitioner lost the services of an additional 32 staff members from March 1 to 7, 2020.  P. Ex. 9; P. Ex. 3 at 2-4.  According to Petitioner, it is normal for three to seven residents to die each month.  P. Ex. 3 at 4.

It is my opinion based on all the evidence presented to me, that Petitioner's infection control nurse, and other staff, as well as the residents' individual primary care physicians and their physician extenders (physician assistants (PA) and nurse practitioners (NP), made a heroic effort to care for and save residents.  Although it is necessary and important for federal and state surveyors to have access to Petitioner to conduct surveys and investigations whenever necessary, there is no doubt that in this case the survey

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could have been done later to avoid any potential harm to residents due to the surveyors' distracting presence during a critical emergency that truly involved life and death.  It is important for the reader to understand that surveyors provide no care to a resident even in such critical circumstances.  Rather, surveyors demand attention, answers, and assistance, that not only requires the time of managers but also staff.  While that is the right of CMS and the state survey agency, it would have been a better exercise of discretion to not create any distraction that could have adversely impacted resident care during the period of the survey and the period for response to the survey allegations.  The benefit of the survey process in this case would not have been diminished by waiting to conduct the survey until after the emergency passed as there is no evidence that the survey in this case served to protect any residents at the time it was conducted.

As explained hereafter, I conclude that Petitioner's staff did almost everything correctly in this case.  However, they did commit a regulatory violation that posed a risk for more than minimal harm and that amounted to immediate jeopardy.  Therefore, enforcement remedies are approved.

However, I make no findings or determinations that the errors of Petitioner's staff resulted in the spread of COVID-19 or the death or injury of any resident.

I.  Procedural History

Petitioner is a skilled nursing facility (SNF) participating in the federal Medicare program and a nursing facility (NF) participating in the State of Washington Medicaid program.  Petitioner is located in Kirkland, Washington.  State and federal surveyors conducted a complaint investigation of Petitioner from March 6 through 16, 2020 (March 16 survey).  The surveyors concluded, and CMS alleges, that Petitioner was not in substantial compliance with Medicare participation requirements based on seven regulatory violations that posed a risk for more than minimal harm to Petitioner's residents, three of which are alleged to have posed immediate jeopardy.  Joint Stipulations of Undisputed Facts and Joint Statement of Issues Presented for Hearing (Jt. Stip.) ¶¶ A.1-3; CMS Ex. 1.

On March 18, 2020, CMS notified Petitioner of its initial determination based on the March 16 survey to terminate Petitioner's provider agreement effective April 8, 2020, if Petitioner did not remove the immediate jeopardy to its residents before that date.  CMS Ex. 3 at 1.  CMS also informed Petitioner that CMS imposed a DPNA effective March 21, 2020, and a CMP of $14,200 per day beginning on March 13, 2020, and continuing until the immediate jeopardy was abated.  Petitioner was also informed that it was no longer eligible to conduct a nurse aide training and competency evaluation program (NATCEP).  CMS Ex. 3 at 2; Jt. Stip. ¶¶ A.4-5.

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On April 1, 2020, CMS advised Petitioner that a revisit survey conducted March 28, 2020, determined that immediate jeopardy was abated, and that Petitioner's provider agreement would not be terminated on April 8, 2020.  However, CMS advised Petitioner that if it did not return to substantial compliance with program participation requirements by September 16, 2020, its provider agreement would be terminated on that date.  CMS Ex. 4 at 1-2.  CMS advised Petitioner that the CMP was changed to $13,585 per day beginning on February 12 and continuing through March 27, 2020, and the DPNA was in effect from March 21 through March 27, 2020.  CMS Ex. 4 at 2-3; Jt. Stip. ¶ A.6-7.

On April 4, 2020, CMS notified Petitioner that the Statement of Deficiencies (SOD) for the investigation completed March 16, 2020, was revised on April 4, 2020, and that the revised version superseded prior versions.  No action was taken regarding the enforcement remedies previously imposed.  CMS Ex. 5; Jt. Stip. ¶ A.8-9.  The parties stipulated that the state agency conducted a subsequent revisit on July 1, 2020, that determined that Petitioner returned to substantial compliance; and that CMS had taken no subsequent action to modify the enforcement remedies imposed by CMS as modified on April 1, 2020.  Jt. Stip. ¶ A.10-11.

Petitioner timely requested a hearing before an administrative law judge (ALJ) on April 8, 2020 (RFH).  Jt. Stip. ¶ A.12.  Petitioner's motion to expedite proceedings was granted on May 4, 2020.3   CMS filed a motion for partial summary judgment on September 8, 2020.  Petitioner filed a motion for summary judgment on October 2, 2020.  On December 3, 2020, oral argument was heard on the motions for summary judgment.  The motions for summary judgment were denied on January 26, 2021.4

A trial on the merits was convened April 5 through 9, 2021, and a transcript (Tr.) was prepared.  CMS offered as evidence CMS Exs. 1 through 45,5 which were admitted as

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evidence.  Tr. 31-34.  Petitioner offered P. Exs. 1 through 73, which were admitted as evidence.  Tr. 34-44.  CMS called the following witnesses:  Captain (Capt.) Alex Garza, RN, Public Health Service; Investigator Delores Usea, RN, DNP; CMS Nurse Consultant Francoise St. Aubin, RN; Patricia Rimer, RN, MSN; and William A. Schwartzman, MD.  Petitioner called the following witnesses:  Morgan J. Katz, MD; Ngim (Christy) Carmichael, PA; Alice Cortez, RN; Chelsey Earnest, RN, Petitioner's Interim Director of Nursing (DON); Ellie Basham, Petitioner's Administrator; Peter A. Hashisaki, MD; Nancy Butner, Northwest Divisional Vice President for Life Care Centers of America; and Dhirendra Kumar, MD, Petitioner's Medical Director.

CMS filed a post-hearing brief (CMS Br.) on June 10, 2021.  Petitioner also filed its post-hearing brief (P. Br.) on June 10, 2021.  Petitioner filed its post-hearing reply brief (P. Reply) on June 22, 2021.  CMS filed its post-hearing reply brief (CMS Reply) on July 12, 2021.

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.6   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.7   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).

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Petitioner was notified in this case that it may be ineligible to conduct a NATCEP.  Pursuant to sections 1819(b)(5) and 1919(b)(5) of the Act, SNFs and NFs may only use nurse aides who have completed a training and competency evaluation program.  Pursuant to sections 1819(f)(2) and 1919(f)(2) of the Act, the Secretary was tasked to develop requirements for approval of NATCEPs and the process for review of those programs.  Sections 1819(e) and 1919(e) of the Act impose upon the states the requirement to specify what NATCEPs they will approve that meet the requirements that the Secretary established and a process for reviewing and re-approving those programs using criteria the Secretary set.  The Secretary promulgated regulations at 42 C.F.R. pt. 483, subpt. D.  Pursuant to 42 C.F.R. § 483.151(b)(2) and (f), a state may not approve and must withdraw any prior approval of a NATCEP offered by a SNF or NF that has been:  (1) subject to an extended or partial extended survey under sections 1819(g)(2)(B)(i) or 1919(g)(2)(B)(i) of the Act; (2) assessed a CMP of not less than $11,160 (45 C.F.R. § 102.3 (Table)) (2020); or (3) subject to termination of its participation agreement, a DPNA, or the appointment of temporary management.  Extended and partial extended surveys are triggered by a finding of "substandard quality of care" during a standard or abbreviated standard survey and involve evaluating additional participation requirements.  "Substandard quality of care" is identified by the situation where surveyors identify one or more deficiencies related to participation requirements established by 42 C.F.R. §§ 483.10, 483.12, 483.24, 483.25, 483.40, 483.45, 483.70 or 483.80, which are found to constitute either immediate jeopardy, a pattern of or widespread actual harm that does not amount to immediate jeopardy, or a widespread potential for more than minimal harm that does not amount to immediate jeopardy and there is no actual harm.  42 C.F.R. § 488.301.  The CMP proposed by CMS triggers the ineligibility to be approved to conduct a NATCEP in this case.  Ineligibility to conduct a NATCEP is not an enforcement remedy that the state agency and CMS have the authority or discretion to impose.  42 C.F.R. § 488.406 (list of remedies CMS and the state agency are authorized to impose in addition to termination).

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); 42 C.F.R. §§ 488.408(g), 498.3(b)(13).  A facility has a right to appeal a "certification of noncompliance leading to an enforcement remedy."  42 C.F.R. §§ 488.408(g)(1), 488.330(e), 498.3(b)(13).  However, the choice of remedies, or the factors CMS considered when choosing remedies, are not subject to review.  42 C.F.R. § 488.408(g)(2).  A facility may only challenge the scope and severity level of noncompliance determined by CMS if a successful challenge would affect the range of the CMP that may be imposed or impact the facility's authority to conduct a NATCEP.  42 C.F.R. § 498.3(b)(14), (d)(10)(i).  The CMS determination as to the level of noncompliance, including the finding of immediate jeopardy, "must be upheld unless it is clearly erroneous."  42 C.F.R. § 498.60(c)(2); Woodstock Care Ctr., DAB No. 1726 at 9, 39 (2000), aff'd, Woodstock Care Ctr. v. Thompson, 363 F.3d 583 (6th Cir. 2003).  The

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Board has long held that the net effect of the regulations is that a provider has no right to challenge the scope and severity level assigned to a noncompliance finding, except in the situation where that finding was the basis for an immediate jeopardy determination.  See, e.g., Ridge Terrace, DAB No. 1834 (2002); Koester Pavilion, DAB No. 1750 (2000).  ALJ review of a CMP is subject to 42 C.F.R. § 488.438(e).

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).

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.8   Rather, the Board has 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

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ALJ), DAB No. 1663 (1998) (after remand), aff'd, Hillman Rehab. Ctr. v. United States, No. 98-3789 (GEB), 1999 WL 34813783 (D.N.J. May 13, 1999).  The Board has indicated that CMS has the initial burden of production to make a prima facie showing of noncompliance.  If CMS makes a prima facie showing, then the facility bears the burden to show, by a preponderance of the evidence on the record as a whole, that it was in substantial compliance or had an affirmative defense.  Evergreene Nursing Care Ctr., DAB No. 2069 at 7 (2007).  The Board has not clearly defined the quantum of evidence CMS needs to present to meet its burden of making a prima facie showing.  The Board has stated that CMS must come forward with "evidence related to disputed findings that is sufficient (together with any undisputed findings and relevant legal authority) to establish a prima facie case of noncompliance with a regulatory requirement."  Id.; Batavia Nursing & Convalescent Ctr., DAB No. 1904.  "Prima facie" means generally that the evidence is "[s]ufficient to establish a fact or raise a presumption unless disproved or rebutted."  Black's Law Dictionary 1228 (8th ed. 2004).  One might conclude that if 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 fact as more likely true and to raise a presumption, subject to being disproved or rebutted.  However, the Board has never specifically ruled that the CMS prima facie case must be supported by preponderant evidence, or what happens if it is not, including whether the burden shifts to Petitioner or not.  It is unclear from prior Board decisions whether CMS can make a prima facie showing with little more than mere allegations or a scintilla of evidence.  In this case based on the following analysis, I conclude that CMS has made its prima facie showing of noncompliance by a preponderance of the evidence.

Petitioner challenges the Board's allocation of the burdens in its request for hearing.  RFH at 17-18.  Petitioner argues that the Board's policy imposing the burden on Petitioner to show substantial compliance with program participation requirements is inconsistent with the Administrative Procedure Act (APA), 5 U.S.C. § 556(d).  Petitioner argues that CMS, as the proponent of the order imposing sanctions "has the burden to sustain the order" under 5 U.S.C. § 556(d).  RFH at 17.  Section 556(d) of 5 U.S.C. establishes hearing procedures applicable in hearings conducted pursuant to the APA, specifically those hearings conducted pursuant to 5 U.S.C. §§ 553 and 554.  Pursuant to 5 U.S.C. § 556(d), "[e]xcept as otherwise provided by statute, the proponent of a rule or order has the burden of proof."  Petitioner's view is that CMS is proposing an order imposing enforcement remedies against Petitioner in this case.  Petitioner reasons that CMS, therefore, bears the burden of proof under 5 U.S.C. § 556(d).  In Vandalia Park, DAB No. 1940 (2004), the Board explained its view that in that case the petitioner was the proponent of an order that it was in compliance with Medicare participation requirements.  Therefore, the Board concluded that there was no violation of 5 U.S.C. § 556(d).  The Board also concluded in that case, revisiting the Hillman line of cases, that it was not necessary for the Secretary to engage in rulemaking to promulgate a regulation

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specifying the allocation of the burden of persuasion.  Vandalia Park at 13-19.  The Board has consistently addressed its allocation of the burden of proof, which has been upheld by the federal courts.  See e.g., Batavia Nursing & Convalescent Ctr., DAB No. 1904 at 15 (2004), aff'd, Batavia Nursing & Convalescent Ctr., 129 Fed. App'x 181 (6th Cir. 2005).  I conclude that the Board's rationale for both conclusions is persuasive and they are appropriately applied in this case.  I find no need to restate the Board's detailed analysis in this decision.

Petitioner also argues that the Board's allocation of the burden of persuasion to Petitioner "operates to deprive the Center of its property without due process of law by permitting the Board to minimize or to disregard its evidence of compliance."  RFH at 18.  Petitioner has a right to the procedural due process provided by sections 1128A(c)(2) and 1866(h) of the Act and 42 C.F.R. pt. 498, including, for example, the right to a hearing, representation, to call witnesses and present documentary evidence, to confront and cross-examine witnesses, and to submit argument.  Petitioner does not explain how the Board's allocation of the burden of persuasion deprives it of any of the provided due process rights or how there is any violation of Petitioner's substantive due process.  Petitioner asserts that the allocation permits the Board, and presumably this ALJ, to disregard or minimize the evidence presented by Petitioner to meet its burden to show it was in substantial compliance with program participation requirements.  This decision reflects a detailed analysis of the evidence and arguments presented by Petitioner and CMS.  No evidence or argument is disregarded, though the credibility of arguments and the weight of the evidence are judged.  Furthermore, Petitioner ultimately has the right to seek review of this decision and any subsequent Board decision by the appropriate U.S. Circuit Court of Appeals, which can pass upon the thoroughness of both decisions.  I conclude that Petitioner suffers in this case no deprivation of its due process rights.

C.  Elements of the CMS Prima Facie Case

During briefing on summary judgment Petitioner argued that, with regard to all the allegations of noncompliance in this case, CMS cites no "clear, formally promulgated, legally binding criteria that put [Petitioner] on reasonable notice of specific obligations or prohibitions that CMS would enforce under any of the cited regulations."  Petitioner's Supplemental Brief (P. Supp.) at 1.  Petitioner cited Supreme Court decisions in Kisor v. Wilkie, 588 U.S. __, 139 S. Ct. 2400 (2019) and Azar v. Allina Health Services, 588 U.S. __, 139 S. Ct. 1804 (2019), in support of its argument that CMS may not in this case impose substantive legal obligations upon Petitioner that are not properly promulgated.  This legal argument challenged the sufficiency of the regulations at issue and CMS interpretive policies and the adequacy of the notice of substantive conduct they require or prohibit.  I ruled on summary judgment that this argument must be resolved against Petitioner as a matter of law.  My January 26, 2021 Ruling Denying Cross-Motions for Summary Judgment (Summary Judgment Ruling) is unchanged.  This discussion from

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the Summary Judgment Ruling is included in this decision to clarify that the substantive requirement of each regulation CMS alleges Petitioner violated must be established by CMS as part of its prima facie case.

Petitioner's reliance on Kisor is misplaced in this forum.9   In Kisor, the Court determined to uphold the court-created doctrine that it is appropriate for federal courts to defer to a federal executive agency's interpretation of its regulations, but with some new parameters.  Kisor applies only to the federal courts and has no application to my decision-making.

Having dispensed with further consideration of Kisor, I turn to Allina.  Allina is significant because the Court clarified in Allina that the Secretary's rule-making authority, such as at issue in this case, is governed by section 1871 of the Act (42 U.S.C. § 1395hh), rather than 5 U.S.C. § 553 (the APA).  Allina, 139 S. Ct. at 1809.  The Court also pointed out that under section 1871 of the Act, the Secretary must engage in formal rule-making for any "rule, requirement, or other statement of policy (other than a national coverage determination) that establishes or changes a substantive legal standard governing the scope of benefits, the payment for services, or the eligibility of individuals, entities, or organizations to furnish or receive services or benefits under [Medicare]."  Id. (citing 42 U.S.C. § 1395hh(a)(2)).  The Court found that the phrase "substantive legal standard" used in section 1871 of the Act is different than "substantive rule" which is used in 5 U.S.C. § 533(d).  Allina, 139 S. Ct. at 1810-14.  However, the Court did not define "substantive legal standard."  Id. at 1814.  The Court stated further questions about section 1871 of the Act would wait for future cases and stated the Court limited its holding to determining that there is no interpretive rule or statement of policy exception under section 1871 of the Act as there is under 5 U.S.C. § 553(b)(3)(A) and (d)(2).  Id.

On December 3, 2020, the General Counsel for HHS (OGC) issued an "Advisory Opinion 20-05 On Implementing Allina."  CMS Ex. 39.  OGC recognized that in Allina, the Court determined that the Secretary must use notice and comment rulemaking in certain circumstances where formal rulemaking would not be required by the APA.  The advisory opinion was issued to clarify "what the public can expect the Center for Medicare to do in order to satisfy Allina's requirements regarding notice-and-comment rulemaking."  CMS Ex. 39 at 1.  The advisory opinion indicates it is not binding on the Secretary or the federal courts.  Therefore, while the General Counsel's view on what may satisfy the federal courts, including the Supreme Court, is interesting, it is not binding.

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Petitioner's theory (as I understand it) is that CMS is not entitled to judgment on any allegation of noncompliance in this case, as CMS has not cited in the SOD (the charges against Petitioner) any "clear, formally promulgated, legally binding criteria that put [Petitioner] on reasonable notice of specific obligations or prohibitions that CMS would enforce under any of the cited regulations."  P. Supp. at 1.  I construe Petitioner's argument to be that the regulations that CMS seeks to enforce against Petitioner should be found unenforceable in light of Allina.  However, the decision in Allina is very limited in its scope.  There is no indication in Allina that the Court intended to invalidate any existing regulations of the Secretary, just the policy challenged in that case that was not promulgated by notice and comment rulemaking in accordance with section 1871 of the Act.10

Allina does provide Petitioner some comfort to the extent that the Court is clear that in order to establish or change a substantive legal standard governing the eligibility of Petitioner to furnish services or receive payment for services, the Secretary (or his delegees) must engage in rulemaking pursuant to section 1871 of the Act.  The issue before me is never whether a regulation can survive Constitutional scrutiny; rather, the issue is whether or not Petitioner factually had notice of what Petitioner had to defend, i.e., whether CMS has presented sufficient evidence of the existence of a standard to which it seeks to hold Petitioner and of which Petitioner had knowledge.  The Board has long recognized that this is an element of the CMS prima facie showing.  In Hillman Rehab. Ctr., the Board described the elements of the CMS prima facie case in general terms as follows:

HCFA [now known as CMS] must identify the legal criteria to which it seeks to hold a provider.  Moreover, to the extent that a provider challenges HCFA's findings, HCFA must come forward with evidence of the basis for its determination, including the factual findings on which HCFA is relying and, if HCFA has determined that a condition of participation was not met, HCFA's evaluation that the

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deficiencies found meet the regulatory standard for a condition-level deficiency.

DAB No. 1611 at 8 (emphasis added).  Thus, CMS has the initial burden of coming forward with sufficient evidence to show that its decision to impose an enforcement remedy is legally sufficient under the statute and regulations.  To make a prima facie case that its decision was legally sufficient, CMS must:  (1) identify the statute, regulation or other legal criteria to which it seeks to hold the provider; (2) come forward with evidence upon which it relies for its factual conclusions that are disputed by Petitioner; and (3) show how the deficiencies it found amount to noncompliance that warrants an enforcement remedy, that is, that there was a risk for more than minimal harm due to the regulatory violation.  Section 1871 of the Act requires that the Secretary promulgate by regulation a rule, requirement, or other statement of policy, except for national coverage determinations, that establish or change a substantive legal standard that governs the scope of benefits, the payment for services, or the eligibility of individuals, entities, or organizations to furnish or receive services or benefits under Medicare.  Therefore, the required notice for any substantive legal standard is promulgation as a regulation.  Act § 1871(a)(1)-(2).  If CMS seeks to enforce an interpretative rule or policy that effectively imposes a substantive legal standard without notice and comment rulemaking under section 1871 of the Act, then Allina indicates that that substantive legal standard is not enforceable.

Petitioner argued on summary judgment that CMS cannot show as part of its prima facie case that the substantive legal standards it seeks to impose are "clear, formally promulgated, [and] . . . put [Petitioner] on reasonable notice of specific obligations or prohibitions that CMS would enforce under any of the cited regulations."  P. Supp. at 1.  To the extent that Petitioner intends the term "clear" to refer to whether the regulation can be understood and provides reasonable notice of the substantive legal standard established by the regulation, that question must be analyzed for each regulation.  Therefore, it is necessary to evaluate, as Petitioner requested, whether CMS seeks to impose a substantive legal standard against Petitioner that was not properly promulgated.  It is also necessary to consider whether the regulations gave Petitioner notice of the prohibitions and/or obligations CMS now seeks to enforce against Petitioner.  In my ruling on summary judgment, I addressed each regulation and concluded no regulation was defective.  My analysis and conclusions are unchanged.

First, I address the question of whether the regulations Petitioner allegedly violated were "formally promulgated."  Petitioner does not argue that the regulations CMS alleges Petitioner violated are invalid because they were promulgated using the notice and comment rulemaking of 5 U.S.C. § 553, rather than that prescribed by section 1871 of the Act.  CMS seeks to impose liability based on alleged violations of the following regulations:  42 C.F.R. §§ 483.25, 483.30(d), 483.70(d)(1)-(2), 483.70(h)(1)-(2),

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483.20(f)(5), 483.70(i)(1)-(5), 483.75(a)(2), (h), (i); and 483.80(a)(1), (2), (4), (e), (f).  All these regulations were promulgated by notice and comment rulemaking with the final rule published at 81 Fed. Reg. 68,688 (Oct. 4, 2016).  It is not clear from the face of the final rules whether they were promulgated using the procedures of 5 U.S.C. § 553 or section 1871 of the Act, but Petitioner has not raised that issue.  Both 42 C.F.R. §§ 483.70 and 483.75 were changed by a final rule published at 82 Fed. Reg. 32,256 (July 13, 2017).  There was a further change to 42 C.F.R. § 483.70 by final rule published at 84 Fed. Reg. 34,718 (July 18, 2019).  Changes to 42 C.F.R. § 483.80 were published as interim final rules with comment periods in 85 Fed. Reg. 27,550 (May 8, 2020) and 85 Fed. Reg. 54,820 (Sep. 2, 2020).  The interim final rule at 85 Fed. Reg. 27,550 states that its effective date is May 8, 2020, but also states that it is applicable beginning on March 1, 2020, or January 27, 2020.  85 Fed. Reg. 27,550.  The interim final rule adds a new subsection 42 C.F.R. § 483.80(g).  85 Fed. Reg. 27,550, 27,627.  No violation for 42 C.F.R. § 483.80(g) is alleged in the SOD.  CMS Ex. 2.  Accordingly, the interim final rule published at 85 Fed. Reg. 27,550 is not at issue in this case.  The effective date of the interim final rule published at 85 Fed. Reg. 54,820 is stated to be September 2, 2020, but it is also stated that the regulations are applicable for the duration of the public health emergency for COVID-19.  85 Fed. Reg. 54,820.  The interim final rule published at 85 Fed. Reg. 54,820 added 42 C.F.R. § 483.80(h).  84 Fed. Reg. 54,820, 54,873.  The SOD alleges no violation of 42 C.F.R. § 483.80(h).  CMS Ex. 2.  Therefore, the interim final rule published at 85 Fed. Reg. 54,820 is also not at issue in this case.  Accordingly, I conclude that the regulations that CMS cites as having been violated by Petitioner were all promulgated using notice and comment rulemaking.

The second issue raised by Petitioner to be examined is whether the regulations CMS alleges were violated gave Petitioner notice of the substantive legal standards with which Petitioner was required to comply.  I reviewed the regulatory participation requirements CMS alleges were violated in my summary judgment ruling.  I did a similar review and analysis mentioned in the following discussion of each deficiency alleged by CMS.  My review of the regulations at issue in this case based on the allegations in the SOD (CMS Ex. 1) shows that all the regulatory provisions were promulgated by notice and comment rulemaking.  My review also reveals that each of the regulations establish substantive legal requirements that are clearly stated.  However, some of the regulatory provisions refer to standards of practice or care or similar standards, for which CMS must present evidence as part of its prima facie case subject to rebuttal by Petitioner.  Whether CMS has met its burden by producing the required evidence and whether it has been rebutted by Petitioner is discussed under my Conclusions of Law.

D.  Collateral Estoppel

Petitioner also argued in moving for summary judgment that CMS is bound by the state ALJ's findings of fact in the state enforcement action against Petitioner.  Petitioner

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argued that the state ALJ found that the facts alleged by CMS as the basis for noncompliance in this case are the same facts as those alleged by the state agency in the state enforcement proceeding before the state ALJ.  According to Petitioner, the state ALJ found that the material facts that are alleged by CMS as the bases for the citations of noncompliance are not supported by a preponderance of the evidence.  Petitioner requested that I accept the facts as found by the state ALJ and that I take the next step and determine Petitioner was entitled to judgment as a matter of law.  Petitioner's Motion for Leave to File Motion for Summary Judgment, Motion for Summary Judgment, and Request for Oral Argument (P. SJ Br.) at 1-2.

Brief examination of the state administrative procedures and the state ALJ's decision is required prior to addressing Petitioner's erroneous reliance on Supreme Court precedent related to collateral estoppel.

Petitioner placed the state ALJ's decision in evidence as P. Ex. 70 (state decision).  The state decision shows that CMS did not participate in the proceedings before the state ALJ.  P. Ex. 70 at 2-3.  The state decision shows that the state administrative proceeding was based on a state statement of deficiencies (state SOD) issued March 26, 2020, that alleged violations of state regulations rather than federal regulations.  The state ALJ noted that the state SOD did incorporate by reference the findings detailed in the federal SOD (CMS Ex. 1), which included more specific factual findings.  P. Ex. 70 at 7-8.  However, the state ALJ noted that the federal SOD, which included two additional allegations of noncompliance, was not under appeal before him.  P. Ex. 70 at 8 n.1.  The state ALJ also quoted Wash. Admin. Code § 388-97-4440(7), which provides that "[f]ederal deficiencies cited on the federal survey report may not be appealed through the state administrative appeals process."  P. Ex. 70 at 34.  The state ALJ found that, although the federal surveyors did not testify in the state proceedings,11 there was no prejudice to Petitioner's right to confront and cross-examine the federal surveyors under the analysis required by the Washington APA (Wash. Rev. Code § 34.05.461(4)).  P. Ex. 70 at 35.  The standard for proof in the state administrative proceeding was a preponderance of the evidence, except regarding the imposition of enforcement remedies as discussed hereafter.  P. Ex. 70 at 34 (citing Wash. Admin. Code § 388-02-0485).  Although not specifically stated by the state ALJ, he clearly imposed the burden of proof (the burden of

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production of the evidence and the burden of persuasion) upon the state agency and concluded the state failed to prove most allegations against Petitioner by a preponderance of the evidence.  P. Ex. 70 at 36 (state provided relatively little evidence), 39 (state was unable to show patient care was denied or delayed or what additional measures should have been taken), 40 (state agency has not shown violations with respect to administration or medical director responsibilities), 42 (state agency has not shown clinical records lacked assessments or other required information; state agency has not shown violation of patient confidentiality; state agency has not shown how a more robust quality assurance program would have produced better outcomes), and 43 (state agency has not shown a single incident where care and services that were necessary were not provided).

It is helpful to highlight some of the differences between the state ALJ proceeding and the case before me.

1.  The federal government was not a party to the state ALJ proceeding.  The state ALJ proceeding involved only Petitioner and the state agency.

2.  The noncompliance cited in the federal SOD was not subject to review by the state ALJ but is the subject of review before me.

3.  The federal surveyors did not testify in the state ALJ proceeding.  However, the federal surveyors' findings and conclusions of law were part of the record before and considered by the state ALJ because the federal SOD was incorporated by reference in the state SOD.  The state ALJ specifically found under Washington law that he could consider the federal SOD, even though the federal surveyors did not testify, without offending Petitioner's rights to confront and cross-examine.  The federal surveyors testified at the hearing before me.

4.  The state ALJ imposed the burden of proof on the state agency, requiring that the state agency show by a preponderance of the evidence the noncompliance alleged in the state SOD.  In this proceeding, CMS has the burden of making a prima facie showing of noncompliance.  The quantum of evidence required to make the prima facie showing is not clear based on the regulations or prior Board decisions.  However, it is clear that if CMS makes a prima facie showing the burden of proof (the burdens of production and persuasion) is upon Petitioner and Petitioner only meets that burden by showing it maintained substantial compliance with program participation requirements, thereby rebutting the CMS prima facie case or, alternatively, showing that any noncompliance is excused based on the existence of an affirmative defense.  During oral argument on its motion for summary judgment, Petitioner's counsel minimized the impact of the different allocation of the burden of proof between the state ALJ proceeding and this

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proceeding.  However, imposing the burden on the government to prove on the whole record by a preponderance of the evidence, i.e., that it was more likely than not that there was noncompliance, may have a different result than requiring Petitioner to prove by a preponderance of the evidence that it remained in substantial compliance, even on the same evidence.

5.  As discussed hereafter, the standards for review of remedies imposed by the state agency are also different than the standards applicable in the case before me.

I also note that Petitioner did not have a complete victory in the proceedings before the state ALJ.  The state ALJ found that the state agency did prove some allegations of violations of state participation requirements (P. Ex. 70 at 44, 46) and the state ALJ approved the imposition of the remedy of placing conditions on Petitioner's license (P. Ex. 70 at 43, 49-50).  Although not stated in his findings of fact, the state ALJ stated in his analysis that Petitioner did not satisfy, during parts of a few days, the state requirement for physician services 24 hours per day in case of emergency as required by Wash. Admin. Code § 388-97-1260.  P. Ex. 70 at 36-37.  The state ALJ also stated in his analysis, but not his findings of fact, that Petitioner violated the requirement relating to effective disinfecting procedures under Wash. Admin. Code § 388-97-1320(5)(c), at least as to one staff member and the use of bleach wipes.  P. Ex. 70 at 39.12   The state ALJ stated that there may have been some incorrect use of sanitizing wipes and that there may not have been a doctor on site for a day or two when the medical director became ill and was not coordinating patient care.  P. Ex. 70 at 44.  He stated "[t]he evidence at hearing indicates that [Petitioner] was not in substantial violation of the program rules as alleged, but there were some violations proven."  P. Ex. 70 at 44.  He also stated "[t]he [state agency] has shown that [Petitioner] failed to adequately train at least one staff member in the use of the sanitization wipes, there may not have been a doctor on site for one or two days, and the medical director was probably not overseeing care during much or even most of his illness."  P. Ex. 70 at 46.  He found that "actual adverse impacts were not shown," but "there was potential for these lapses in practice to adversely impact patients."  P. Ex. 70 at 46.  Pursuant to Wash. Admin. Code § 388-97-4460(4)(j), the state agency may impose as a remedy reasonable conditions on a nursing home's license based on the nursing home's failure or refusal to comply with Washington requirements related to nursing home operations.  P. Ex. 70 at 44.  The state ALJ upheld the imposition of conditions upon Petitioner's state license.  P. Ex. 70 at 50.  The state ALJ found the state agency met its burden to show by a preponderance of the evidence that:  (1) Petitioner failed to ensure all staff had adequate infection control training related to the use of

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sanitizing wipes; (2) for a day or two Petitioner did not have physician services available on site; and (3) the medical director was not coordinating patient care.  Therefore, I infer that these were the bases for the state ALJ to approve the remedy.13

The state ALJ reviewed the imposition of remedies against Petitioner by the state agency.  The state ALJ stated that the standard of review for the imposition of remedies is an abuse of discretion standard and the burden is on Petitioner to show the state agency abused its discretion, apparently by a preponderance of the evidence.  The state ALJ concluded it was an abuse of discretion for the state agency to order that Petitioner stop accepting new residents.  However, the state ALJ concluded that imposing conditions on Petitioner's license was not an abuse of discretion.  P. Ex. 70 at 49-50.

The standards for review of the imposition of remedies by the state agency and CMS are different.  Unlike the state ALJ proceeding, the enforcement remedies CMS seeks to impose include a CMP.  CMS Exs. 3, 4; Jt. Stip. ¶ A.4.  Pursuant to 42 C.F.R. § 498.60(c)(2), the CMS determination of the level of noncompliance in a case involving a CMP must be upheld, unless it is clearly erroneous.  The Board has held that the burden is upon a facility to show that the declaration of immediate jeopardy was clearly erroneous.  Woodstock Care Ctr., DAB No. 1726 at 9, 38 (2000), aff'd, Woodstock Care Ctr. v. Thompson, 363 F.3d 583 (6th Cir. 2003).  CMS's determination of immediate jeopardy is presumed to be correct, and Petitioner has a heavy burden to demonstrate clear error in that determination.  Yakima Valley Sch., DAB No. 2422 at 8-9 (2011); Cal Turner Extended Care Pavilion, DAB No. 2384 at 14 (2011); Brian Ctr. Health & Rehab./Goldsboro, DAB No. 2336 at 9 (2010) (citing Barbourville Nursing Home, DAB No. 1962 at 11 (2005), aff'd, Barbourville Nursing Home v. U.S. Dep't of Health & Human Srvs.,174 F. App'x 932 (6th Cir. 2006)); Maysville Nursing & Rehab. Facility, DAB No. 2317 at 11 (2010); Liberty Commons Nursing & Rehab. Ctr.– Johnston, DAB No. 2031 at 18-19 (2006), aff'd, Liberty Commons Nursing & Rehab. Ctr.–Johnson v. Leavitt, 241 F. App'x 76 (4th Cir. 2007).  "Once CMS presents evidence supporting a finding of noncompliance, CMS does not need to offer evidence to support its determination that the noncompliance constitutes immediate jeopardy; rather, the burden is on the facility to show that that determination is clearly erroneous."  Cal Turner, DAB No. 2384 at 14-15 (citing Liberty Commons Nursing & Rehab. Ctr.–Johnston, 241 F. App'x 76 at 3-4).  The clearly erroneous standard is not defined by the Secretary in 42 C.F.R. pts. 488 or 498.  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

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ed. 2004).  The U.S. Supreme Court has addressed the "clearly erroneous standard" in the context of the federal APA.  The Court described the preponderance of the evidence standard, the most common standard, as requiring that the trier-of-fact believe that the existence of a fact is more probable than not before finding in favor of the party that had the burden to persuade the judge of the fact's existence.  In re Winship, 397 U.S. 358, 371-72 (1970); Concrete Pipe & Prods. of Cal., Inc. v. Constr. Laborers, 508 U.S. 602, 622 (1993).  The "substantial evidence" standard considers whether a reasonable mind might accept a particular evidentiary record as adequate to support a conclusion.  Consol. Edison, 305 U.S. 197, 229 (1938); Dickinson v. Zurko, 527 U.S. 150, 162 (1999).  Under the "clearly erroneous" standard, a finding is clearly erroneous even though there may be some evidence to support it if, based on all the evidence, the reviewing judge or authority has a definite and firm conviction that an error has been committed.  United States v. U.S. Gypsum Co., 333 U.S. 364, 395 (1948); Dickinson, 527 U.S. at 162; Concrete Pipe, 508 U.S. at 622.  The Board has provided additional guidance.  A finding of immediate jeopardy does not require a finding of actual harm, only a likelihood of serious harm.  Dumas Nursing & Rehab., L.P., DAB No. 2347 at 19 (citing Life Care Ctr. of Tullahoma, DAB No. 2304 at 58 (2010), aff'd, Life Care Ctr. of Tullahoma v. Sec'y of U.S. Dep't of Health & Human Servs., 453 F. App'x 610 (6th Cir. 2011)).  The definition of immediate jeopardy at 42 C.F.R. § 488.301 does not define "likelihood" or establish any temporal parameters for potential harm.  Agape Rehab. of Rock Hill, DAB No. 2411 at 18-19 (2011).  The duration of the period of immediate jeopardy is also subject to the clearly erroneous standard.  Brian Ctr. Health & 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 danger appears and how serious the potential consequences are.  Woodstock Care Ctr., DAB No. 1726.

Having reviewed the state ALJ proceeding and decision and the differences between the state proceeding and this proceeding, I turn to Petitioner's collateral estoppel argument.14   Petitioner wanted me to deny CMS the opportunity to litigate the facts on grounds that those facts were litigated between Petitioner and the state agency before the state ALJ.  Petitioner argued that, despite the fact CMS was not a party to the state proceeding, CMS should be bound by the factual findings of the state ALJ through application of the doctrine of collateral estoppel.  Petitioner incorrectly asserted that it is "well-established

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federal law" that CMS may not relitigate before me the same factual issues it claims were resolved against CMS by the state ALJ, even though CMS was not a party to that proceeding.  P. SJ Br. at 1.  Petitioner incorrectly relied upon the Supreme Court decision in Parklane Hosiery Co. v. Shore, 439 U.S. 322 (1979).  Petitioner's analysis and suggested application of Parklane are faulty.  Indeed, it is not "well-established federal law" that CMS may not relitigate the facts before me and the Supreme Court has provided guidance leading to the contrary conclusion.  CMS has never litigated the fact issues in this case.  Even if one concluded that CMS was involved in litigating the fact issues before the state ALJ through the state agency, Supreme Court precedent does not support denying CMS the opportunity to litigate the fact issues before me.

Parklane Hosiery v. Shore involved a shareholder's class action alleging a materially false and misleading proxy statement.  The case was filed in federal district court by Leo Shore (Shore) against Parklane Hosiery and some of its officers, directors, and shareholders (Parklane and Parklane defendants).  The Securities and Exchange Commission (SEC) also filed suit against the Parklane defendants in federal district court based on the same allegations of a materially false and misleading proxy statement.  In the SEC case, the federal court held a four-day trial and then issued a declaratory judgment that the proxy statement was materially false and misleading.  The declaratory judgment was upheld by the U.S. Court of Appeals for the Second Circuit.  Parklane, 439 U.S. at 324-25.  Shore then moved for partial summary judgment in his favor in his case, arguing that Parklane could not relitigate whether the proxy statement was materially false and misleading as found in the SEC case.  The district court denied Shore's motion on grounds that applying collateral estoppel would deny Parklane of its right to a jury trial.  The U.S. Court of Appeals for the Second Circuit reversed, holding that Parklane had a full and fair opportunity to litigate in a nonjury trial and that it was collaterally estopped from obtaining a subsequent jury trial on the same issues of fact.  Id. at 325.  The Supreme Court granted review.  The Supreme Court considered "whether a litigant who was not a party to a prior judgment may nevertheless use that judgment 'offensively' to prevent a defendant from relitigating issues resolved in the earlier proceeding."15   Id. at 326.  The Court commented that collateral estoppel, like res judicata, has two purposes:  (1) protecting litigants from the need to relitigate an identical issue with the same party or a party's privy; and (2) promoting judicial economy by eliminating unnecessary litigation.  However, the Court noted that historically collateral estoppel was limited by the doctrine of mutuality of parties which prevented a party from using collateral estoppel against a party who was not a party to the prior proceeding and bound by the same judgment.  The mutuality doctrine allowed a party who litigated an issue and lost to relitigate the issue with new parties.  Id. at 327.  The Court noted that it previously

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abandoned the mutuality requirement, at least in patent cases.  Id.  The Court described defensive and offensive collateral estoppel.  Collateral estoppel is used defensively when a defendant seeks to estop a plaintiff from relitigating an issue that was resolved against the plaintiff in another proceeding.  Offensive collateral estoppel involves a plaintiff seeking to estop the defendant from relitigating an issue that the defendant litigated and lost in another proceeding.  The Court noted that whether offensive or defensive collateral estoppel is used, the party against whom estoppel is asserted actually litigated and lost in an earlier action.  The Court examined the reasons for why offensive and defensive collateral estoppel should be treated differently.  However, rather than establishing a rule that offensive collateral estoppel may not be used in the federal courts, the Court decided that it is best not to preclude the use of offensive collateral estoppel, but rather, "to grant trial courts broad discretion to determine when it should be applied."  Id. at 331.  The Court stated that as a general rule a trial judge should not permit offensive collateral estoppel if the plaintiff could have easily joined in the earlier action which resulted in the decision it seeks to use to estop the defendant, or it would be unfair to the defendant.  Id.  The Court concluded that no circumstances justified reluctance to permit offensive collateral estoppel against Parklane.  The factors considered:  (1) application of collateral estoppel would not reward Shore (a private plaintiff) who could have joined the prior litigation (it was unlikely Shore could have joined in the SEC litigation); and (2) there was no unfairness to Parklane as it had every incentive to fully and vigorously litigate the SEC action, the judgment in the SEC litigation was not inconsistent with any previous decision, and it is unlikely there would be a different result if the issues were relitigated.  Id. at 332.  Justice Rehnquist dissented on grounds that Parklane was deprived of its right to a jury trial and, possibly, a different result.  Id. at 351-54.

In the case before me, which is brought by Petitioner against CMS, Petitioner is in a position equivalent to a plaintiff in a civil suit.  C.f. Chateau Nursing and Rehab. Ctr., DAB No. 2427 at 8-10 (2011) (in appeal pursuant to 42 C.F.R. pt. 498, treated long term care facility as in position of plaintiff when applying Fed. R. of Civ. P. 41(b)) and cases cited therein.  Petitioner argues for the offensive application of collateral estoppel against CMS.  Petitioner argues that the Supreme Court made clear in Parklane that a federal agency may not relitigate an issue that it lost in another forum.  P. Br. at 4, 9-10.  However, in Parklane, the Court was clear that estoppel should only be considered when the party to be estopped previously litigated and lost.  439 U.S. at 329.  Petitioner is obviously aware that CMS did not participate in the state ALJ proceeding as a party.  Therefore, Petitioner has the problem that CMS did not previously litigate and lose on the fact issues that Petitioner now argues CMS should be precluded from litigating before me.  Petitioner attempts to overcome this obstacle by arguing that CMS chose not to participate in the state proceeding.  Petitioner cites no authority for the proposition that CMS could have intervened as a party in the state proceeding or that intervention would have been allowed.  Because the federal allegations of noncompliance were not at issue

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before the state ALJ, it is difficult to see how CMS may have qualified as an intervenor under the Washington Administrative Procedure Act (Wash. Rev. Code § 34.05.443(1)-(2)).  Petitioner also attaches some significance to the fact the federal surveyors who visited Petitioner's facility did not testify in the state ALJ proceeding but the state surveyors who did not visit the facility did testify.  There is no evidence that either the state agency or Petitioner attempted to subpoena a witness or witnesses from CMS.  However, even if federal surveyors testified, Petitioner cites no authority supporting a conclusion that their presence as witnesses would amount to participation by CMS in the litigation so that the results of that litigation would be binding on CMS.

Petitioner also argues that the state agency was essentially the agent, or surrogate of CMS in the state ALJ proceeding and that CMS should be subject to collateral estoppel on the fact issues resolved by the state ALJ.  P. Br. at 10-13.  The Supreme Court has addressed the situation where a federal agency caused another party to initiate litigation.  On February 22, 1979, just over a month after issuing Parklane, the Supreme Court issued the decision in Montana v. U.S., 440 U.S. 147 (1979).  In that case, the Court identified factors that courts should consider when deciding whether mutuality exists that is sufficient to trigger collateral estoppel.

In 1971, a federal contractor working on a federal dam project in Montana sued the State of Montana arguing that a Montana gross receipts tax unconstitutionally discriminated against the U.S. and its contractors.  There was no question that the litigation was directed and financed by the U.S.  The U.S. also filed a suit against the state in the U.S. District Court of Montana.  The contractor's state-court litigation ended in a Montana Supreme Court decision upholding the tax.  The contractor requested review by the U.S. Supreme Court, but it subsequently withdrew that request at the direction of the U.S.  A subsequent state suit by the contractor in Montana was dismissed based on application of the doctrines of res judicata (claim preclusion) and collateral estoppel (issue preclusion).  Thereafter, the U.S. District Court of Montana (the federal suit) struck down the Montana tax as a violation of the Supremacy Clause of the U.S. Constitution.

The U.S. Supreme Court reversed based on application of the doctrine of collateral estoppel without addressing the merits of the U.S. claim.  Montana, 440 U.S. at 151-53.  The Court, citing prior decisions, stated "[a] fundamental precept of common-law adjudication, embodied in the related doctrines of collateral estoppel and res judicata, is that a 'right, question or fact distinctly put in issue and directly determined by a court of competent jurisdiction . . . cannot be disputed in a subsequent suit between the same parties or their privies . . . .'"  Id. at 153.  The doctrine of res judicata, according to the Court, bars further claims by a party or its privy based on a cause of action for which there was a final judgment on the merits.  Under the doctrine of collateral estoppel, "once an issue is actually and necessarily determined by a court of competent jurisdiction, that determination is conclusive in subsequent suits based on a different cause of action

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involving a party to the prior litigation."  Id.  The Court noted that the doctrines preclude a party from relitigating a matter for which it had a full and fair opportunity to litigate in order to protect adversaries from the burdens of multiple suits and to conserve judicial resources.  The Court concluded that the same interests are implicated when a nonparty to a suit controls litigation in which it has some direct interest and then attempts to relitigate issues previously resolved adversely to the nonparty's interest.  Id. at 153-54.  The Court found that the U.S. controlled the state-court litigation filed by its contractor based on the facts the U.S.:  required the contractor to file the state lawsuit; reviewed and approved the complaint; paid attorney's fees and costs; directed the appeal to the Montana Supreme Court; appeared and submitted an amicus brief in the Montana Supreme Court; and directed the filing and then the withdrawal of the request for U.S. Supreme Court review of the state supreme court decision.  The Court concluded that while the U.S. was not a party to the state-court litigation, it had a sufficient "laboring oar" to trigger estoppel.  Id. at 155.  The Court then considered three factors to determine whether application of collateral estoppel was appropriate:  whether the issues in the present litigation are the same as those previously resolved against the nonparty; whether there was a significant change in the controlling facts or legal principles since the prior lawsuit; and whether there are special circumstances that are a basis for an exception to the application of estoppel.  The Court analyzed the factors and concluded that application of collateral estoppel against the U.S. was appropriate.  Id. at 155-64.

However, analysis of the Supreme Court's positions on collateral estoppel does not end with Montana.  On January 10, 1984, the Court issued decisions in U.S. v. Stauffer Chemical Company, 464 U.S. 165 (1984)16 and U.S. v. Mendoza, 464 U.S. 154 (1984).  Both opinions were delivered by Justice Rehnquist.

The Mendoza case involved a Filipino national who filed a petition for naturalization under an expired statute.  The U.S. District Court and U.S. Court of Appeals for the Ninth Circuit did not reach the merits of the case because both concluded the U.S. was collaterally estopped from litigating the constitutional issue in the case because of an earlier decision that was adverse to the government in a case brought by other Filipino nationals in the U.S. District Court.  Mendoza, 464 U.S. at 155.  The U.S. Supreme Court agreed with the government's arguments that Parklane's approval of nonmutual offensive collateral estoppel was not to be extended to the U.S.  Id. at 158.  The Court stated that in the interests of relieving parties of the cost and vexation of multiple lawsuits, conserving judicial resources, and preventing inconsistent decisions, the "Court in recent years has broadened the scope of the doctrine of collateral estoppel beyond its common law limits . . . . by abandoning the requirement for mutuality of parties . . . . and

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by conditionally approving the 'offensive' use of collateral estoppel by a non-party to a prior lawsuit."  Id. at 158-59 (citations omitted).  The Court pointed out that its prior decisions in Blonder-Tongue Laboratories, Inc. v. University of Illinois Foundation, 402 U.S. 313 (1971) and Parklane involved disputes over private rights among private litigants.  However, in Mendoza, as in Montana, collateral estoppel was sought against the U.S.  The difference between Mendoza and Montana, however, was that Mendoza was not a party to the earlier litigation against the U.S.  The Court stated it has "long recognized that 'the Government is not in a position identical to that of a private litigant.'"  Id. at 159 (citations omitted).  The Court examined in detail why permitting nonmutual offensive collateral estoppel against the U.S. would be problematic.  Id. at 159-62.  The Court held that "nonmutual offensive collateral estoppel simply does not apply against the government in such a way as to preclude relitigation of issues such as those involved in [Mendoza]."  Id. at 162.  The Court explained that litigation by the government is sufficiently different from private civil litigation in that the interests of economy (I infer to both the private parties involved and the courts) are outweighed by the peculiar constraints of litigation involving the government and the interest of allowing thorough development of legal doctrine through litigation in multiple jurisdictions.  The Court also noted that a contrary result could "disserve the economy interests in whose name estoppel is advanced by requiring the government to abandon virtually any exercise of discretion in seeking to review judgments unfavorable to it."  Id. at 163.  While res judicata prevents the government from relitigating the same cause of action against parties to a prior decision, nonmutual collateral estoppel must give way to the policies identified by the Court.  The Court noted that while it has held the U.S. may be estopped under certain circumstances from relitigating an issue when the parties to both lawsuits are the same, the Court has not permitted estoppel against "the government in the absence of mutuality."  Id. at 163-64.  The U.S. Circuit Courts of Appeal have consistently applied Mendoza's prohibition on the application of nonmutual offensive collateral estoppel against the U.S.  See e.g., Benenson v. Commissioner of IRS, 910 F.3d 690, 697 (2d Cir. 2018) (mutuality can be satisfied by showing privity but it must be shown that the party urging preclusion in the subsequent action "totally controlled and financed" a party in the prior litigation); Harrell v. U.S. Postal Serv., 445 F.3d 913, 921-22 (7th Cir. 2006); Bingaman v. Dep't. of Treasury, 127 F.3d 1431 (Fed. Cir. 1997); Cmty. Hosp. v. Sullivan, 986 F.2d 357, 360 (10th Cir. 1993); Nat'l Med. Enters., Inc. v. Sullivan, 916 F.2d 542, 545 (9th Cir. 1990) (nonmutual offensive collateral estoppel not available against U.S., and court found mutuality did not exist in the case); Sun Towers, Inc. v. Heckler, 725 F.2d 315 at 323 n.8 (5th Cir. 1984) (court found Mendoza applies to all issues, not just constitutional issues).

The Supreme Court in Parklane granted trial courts broad discretion to determine whether offensive collateral estoppel may be used.  Parklane, 439 U.S. at 329.  I conclude that Petitioner's attempt to bind CMS, a component of HHS an agency of the U.S., to the state ALJ's findings of fact is offensive collateral estoppel.  I further

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conclude that Petitioner seeks nonmutual offensive collateral estoppel against CMS.  Under Stauffer mutual defensive collateral estoppel against the U.S. was found acceptable by the Supreme Court.  However, under Mendoza nonmutual offensive collateral estoppel may not be used against the U.S.  Petitioner argues that the state agency was CMS's agent or surrogate in the state ALJ proceedings which, if correct, could lead to the conclusion that Petitioner seeks application of mutual offensive collateral estoppel against CMS.  The Supreme Court's decision in Montana provides the example of the type of analysis a trial court must do to determine whether mutual or nonmutual offensive collateral estoppel is at issue.  There is no dispute in this case that CMS was not actually a party before the state ALJ.  Further, there is no question that the state agency was attempting to enforce Washington requirements applicable to nursing facilities against Petitioner and not federal requirements in the state proceeding.  There is no evidence that CMS instigated the state ALJ proceeding.  To the contrary, there is no dispute that the request for the state ALJ proceeding was made by Petitioner.  There is no evidence that CMS paid any of the costs associated with the state ALJ proceeding.  There is no evidence that CMS directed the preparation or the presentation of the state agency's case before the state ALJ.  Also, there is no issue that federal surveyors did not appear and testify in the state ALJ hearing.  There is no question that documents and testimony considered by the state ALJ are presented for my consideration and that the federal SOD was incorporated by reference in the state SOD.  However, I conclude that these facts do not show that CMS was effectively in control of the state agency in the state ALJ proceeding.  Accordingly, I conclude that Petitioner seeks nonmutual offensive collateral estoppel against CMS and that is not permissible under Mendoza.  Therefore, Petitioner's attempt to bind CMS to the state ALJ's findings of fact fails.

E.  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 are reasonable.

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

A.  Findings of Fact

The following numbered findings of fact are necessary to deciding this case.  42 C.F.R. § 498.74(a).  Each numbered finding of fact is based on the preponderance of the credible

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and weighty evidence discussed following each finding.17   I have carefully considered all the evidence and the arguments of both parties, although not all may be specifically discussed in this decision.  I discuss the credible evidence given the greatest weight in my decision-making.18   I also discuss any evidence that I find is not credible or worthy of weight.  The fact that evidence is not specifically discussed should not be considered sufficient to rebut the presumption that I considered all the evidence and assigned such weight or probative value to the credible evidence that I determined appropriate within my discretion as an ALJ.  There is no requirement for me to discuss the weight given every piece of evidence considered in this case, nor would it be consistent with notions of judicial economy to do so.  Charles H. Koch, Jr., Admin. L. & Prac. § 5:64 (3d ed. 2013).

1.  CMS determined based on the survey completed on March 16, 2020, that Petitioner was not in substantial compliance with program participation requirements beginning February 12, 2020, and the noncompliance posed immediate jeopardy.  Jt. Stip. ¶¶ A.2-7, CMS Exs. 1, 4.

2.  CMS determined based on a revisit survey conducted on March 28, 2020, that immediate jeopardy was abated on March 27, 2020.  Jt. Stip. ¶ A.7; CMS Ex. 4; Tr. 300-01.

3.  Another revisit survey on July 1, 2020, found Petitioner returned to substantial compliance with program participation requirements on July 1, 2020.  Jt. Stip. ¶ A.10; Tr. 300-01.

According to counsel for CMS, Petitioner returned to substantial compliance July 1, 2020.  Immediate jeopardy ended March 27, 2020.  The DPNA also ended March 27, 2020.  Counsel referred to a letter to Petitioner dated September 9, 2020, which has not been placed in evidence.  Tr. 300-01.  The entire period involved in this case is roughly February 12, 2020, the date noncompliance allegedly began, through July 1, 2020, the

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date Petitioner was determined to have returned to substantial compliance with program participation requirements.  Jt. Stip. ¶ A.10-11.  The focus is primarily upon events during the period February 12, 2020, through the end of the survey on March 16, 2020, and through March 28, 2020, when surveyors found Petitioner abated immediate jeopardy.  CMS Exs. 1-2.

4.  The survey completed on March 16, 2020, alleges that Petitioner was not in substantial compliance with seven program participation requirements established by 42 C.F.R. §§ 483.25 (Tag F68419 ) (scope and severity (s/s) L20 ), 483.30(d) (Tag F713) (s/s L), 483.70(d)(1)-(2) (Tag F837) (s/s F), 483.70(h)(1)-(2) (Tag F841) (s/s F), 483.20(f)(5) and 483.70(i)(1)-(5) (Tag F842) (s/s F), 483.75(a)(2), (h), (i) (Tag F865) (s/s

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F), and 483.80(a)(1)-(2), (4), (e), (f) (Tag F880) (s/s L).  Jt. Stip. ¶¶ A.1-3; CMS Ex. 1.

The alleged noncompliance in this case relates to the quality of resident care, requirements for a SNF's governing body, responsibilities of the medical director, providing emergency medical services for SNF residents, requirements for SNF medical records for residents, requirements for protecting resident records, quality control, and infection control.

5.  CMS concedes that in early and mid-February 2020, "fundamental infection control principles were unchanged."  CMS Reply at 2-3.

This case is not uniquely about SARS-CoV-2 and the disease caused by that virus, now known as COVID-19.  It is undisputed that SARS-CoV-2 was the pathogen present in the facility before and during the survey and residents were diagnosed as suffering COVID-19.  However, tuberculosis (TB), influenza (flu), or any number of other pathogens could have been involved rather than SARS-CoV-2 and the disease it causes, COVID-19.  The statutory and regulatory provisions and policies considered in this case, including those of CMS, the CDC, and the State of Washington, would likely have been involved no matter what pathogen was causing the outbreak of infections in Petitioner's residents in late February and early March 2020.  It is necessary to determine what infection control guidelines were in place in February and March 2020, when the outbreak of COVID-19 occurred at Petitioner.

FEDERAL AND STATE GUIDELINES AND EMERGENCY DECLARATIONS – GUIDANCE THAT EXISTED PRIOR TO THE SURVEY IN THIS CASE

6.  CMS asserts that on February 6, 2020, CMS reminded health care facilities that they "must adhere to standards for infection prevention and control . . . . [b]ecause coronavirus infections can rapidly appear and spread."  CMS Reply at 3 (citing P. Ex. 17 at 1).  However, the February 6, 2020 memorandum to which CMS refers (P. Ex. 17) was addressed to "State Survey Agency Directors" rather than health care facilities.  The last paragraph of the memorandum states "[t]his policy should be communicated with all survey and certification staff, their managers, and the State/Regional Office training coordinators immediately."  P. Ex. 17 at 3.  Distribution to healthcare facilities is not reflected on the document and there is no specific instruction for the state survey agency directors to pass on the document to healthcare facilities.  Petitioner has not admitted the date it received the document, and I do not infer that this document was provided to Petitioner before the survey in this case, even though Petitioner placed

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the document in evidence.  Therefore, I find as fact that this document is not a policy statement of which Petitioner had notice or was bound to comply prior to the survey in this case.

7.  CMS agrees that it was not until March 2020, that CMS and CDC infection control guidance started to change but asserts those changes did not change the fundamentals of infection control.  CMS Reply at 3-4.

8.  The 2007 CDC Infection Control Guidelines last updated in July 2019, were in effect and provided guidance (i.e., they do not have the force and effect of a law or regulation) to Petitioner during the period in issue.

9.  Long-term care facilities are not required to have an airborne infection isolation room (AIIR) under the 2007 CDC Guidelines or CMS regulations.  P. Ex. 73 at 35.

10.  The 2007 CDC Guidelines include the following information and recommendations:

a.  The SARS-CoV21 and influenza viruses are examples of infectious agents that are subject to transmission by droplets.

b.  In the case of possible droplet transmissions, it is prudent to don a mask within six to ten feet of a patient when exposure to an emerging or highly virulent pathogens is likely.

c.  SARS-CoV was newly discovered in 2002 or 2003, and it was the first COVID pandemic as it impacted multiple countries.

d.  Incubation of SARS-CoV is two to seven days but could be as many as ten days.  

e.  Signs and symptoms of SARS-CoV include fever, chills, rigors, and possibly headache, myalgia, mild to severe respiratory symptoms, and pneumonia.

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f.  SARS-CoV was most severe for adults and the mortality rate was approximately six percent, with the highest mortality among those with underlying disease and of advanced age.

11.  The CDC recognized that SARS-CoV was a serious threat to healthcare settings with transmission to large numbers of healthcare personnel and patients and that asymptomatic and/or pre-symptomatic transmission was a concern.  Long-term care facilities present challenges due to the large numbers of elderly patients who live and interact together for long periods and are subject to transfer to other facilities and hospitals increasing the risk for infections.  The CDC states that infection control must be balanced with the psychosocial needs of residents. 

12.  The CDC recognized it is important to detect SARS-CoV early by screening for:  (1) symptoms of respiratory infection, (2) history of travel to areas with community spread of SARS-CoV, or (3) close contact (I infer within 6 feet) with a SARS-CoV patient.

13.  The CDC recommended for confirmed or suspected SARS-CoV:

a.  Respiratory hygiene/cough etiquette, including placing a mask over the patient's nose and mouth and physical separation of patients.

b.  Single patient rooms are recommended for patients who require droplet or contact precautions.  Cohorting (placing residents with like symptoms or diagnoses in the same room (P. Ex. 73 at 29)) may be appropriate if single rooms are not available with separation of at least three feet and the use of a curtain room divider.  P. Ex. 73 at 34-35.

c.  For the protection of healthcare workers it was recommended to use standard precautions (including appropriate personal protective equipment (PPE) such as gloves, gowns, face masks, goggles, and face shields) and hand hygiene (soap and water or alcohol-based rubs), transmission-based precautions including contact precautions with emphasis on environmental cleaning, droplet precautions, and, when available, airborne precautions, including use of a fit-tested N95 or higher level respirator, and eye protection.  P. Ex. 73 at 17-21; CMS Ex. 43 at 156.

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14.  The CDC states that not all precautions are necessary for all patient interactions, and healthcare workers should be trained so that they may make good decisions about which PPE to use, particularly if an infectious agent such as SARS-CoV, may not be suspected and is later identified.

15.  Respiratory hygiene/cough etiquette was added to the CDC's standard precautions due to the 2003 SARS pandemic particularly to address undiagnosed patients who enter a healthcare setting.  Education, posting of signs in appropriate languages, use of tissues or surgical masks to cover coughs and sneezes, hand hygiene, and spatial separation of more than three feet are all important elements according to the CDC.

16.  No screening testing for SARS-CoV is identified by the 2007 CDC Guidelines and I infer none was available.

2007 CDC INFECTION CONTROL GUIDELINES.  The CDC issued the 2007 Guideline for Isolation Precautions:  Preventing Transmission of Infectious Agents in Healthcare Setting (2007 CDC Guidelines), which was last updated in July 2019.  Petitioner placed an excerpt of the document in evidence as P. Ex. 73 and CMS placed a slightly different excerpt in evidence as CMS Ex. 43 at 46-251.22

It is undisputed that the 2007 CDC Guidelines were in effect and were guidance for Petitioner in February and March 2020.  P. Ex. 73.  It is important to know, however, that CMS specifically decided not to incorporate CDC guidelines by reference in the infection control regulation at 42 C.F.R. § 483.80, stating:

We believe that facilities need the flexibility to determine which national standard they are going to follow.  We also believe it is appropriate for the different types of national standards that are acceptable to CMS to be included in the sub-regulatory guidance for this rule.  Although we are not requiring that LTC 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

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infection control, and encourage LTC facilities to consider the CDC guidelines.

81 Fed. Reg. 68,688, 68,808 (Oct. 4, 2016).  Therefore, the 2007 CDC Guidelines are not treated as having the force and effect of law; rather, they are evidence of a standard of practice that CMS has found acceptable.  Allina Health Srvcs., 139 S. Ct. 1804.  In fact, CMS gives long-term care facilities significant discretion to determine how to best address infections within the facility.  An AIIR, for example, is not required in long-term care facilities.  In rulemaking in 1989, CMS stated:

[W]e are reinstating the existing requirement for an infection control program, under which the facility has responsibility for overall infection control.  One of these responsibilities is to determine what form isolation should take given the resident's infection.  Not all infections require isolation in single rooms vented to the outside, with a private toilet and handwashing facilities, thus we have deleted these requirements at § 483.65(b).23

54 Fed. Reg. 5316, 5345 (Feb. 2, 1989).  CMS deleted a requirement for a separate infection control committee in 1989, and provided that infection control was part of the quality assurance committee's purview.  CMS's stated purpose in doing so was to avoid requiring an "excessive number" of committees.  CMS also stated that the CMS emphasis was "on the actual performance of a facility in providing care rather than on its capacity to perform."  Id.

Review of the 2007 CDC Guidelines reveals that it is incorrect to think that an outbreak of SARS coronavirus was unprecedented or that CDC had not established any guidelines that might be useful for dealing with a SARS coronavirus outbreak.  The CDC guidelines in effect at the time of the survey did not specifically address SARS-CoV-2, but did address, among others, SARS-CoV, Avian influenza, Clostridium difficile (C. diff.), noroviruses, and community-associated methicillin-resistant staphylococcus aureus.  P. Ex. 73 at 2, 5.  CDC states that in the case of possible droplet transmissions, it is prudent to don a mask within 6 to 10 feet of a patient when exposure to emerging or highly virulent pathogens is likely.  P. Ex. 73 at 13.  The CDC identified influenza virus and SARS-CoV as infectious agents that are subject to transmission by droplets.  P. Ex. 73 at 14.  The CDC states that airborne transmission of SARS-CoV, influenza virus, and

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noroviruses over limited distances has been suggested but not proven.  P. Ex. 73 at 15.  The CDC explains that SARS was a newly discovered respiratory disease that emerged in China in late 2002 and spread to several countries.24   The CDC stated that incubation of SARS-CoV is 2 to 7 days but may be 10 days or longer.  Signs and symptoms include fever, chills, rigors, and possibly headache, myalgia, and mild to severe respiratory symptoms.  Atypical pneumonia was stated to be an important clinical indicator of possible SARS-CoV.  According to the CDC, children are less affected and less likely to transmit SARS-CoV than adults.  The fatality rate of SARS-CoV is approximately six percent, with underlying disease and advanced age contributing to mortality.  P. Ex. 73 at 17-18.  The CDC stated in its 2007 Guidelines that "[o]utbreaks in healthcare settings, with transmission to large numbers of healthcare personnel and patients have been a striking feature of SARS; undiagnosed, infectious patients and visitors were important initiators of these outbreaks."  P. Ex. 73 at 18.  Therefore, the CDC recognized that transmission by pre-symptomatic or asymptomatic carriers of SARS-CoV was a concern.  Transmission was thought to be most likely by the droplet and contact transmission routes, but opportunistic airborne transmission could not be ruled out.  The CDC states that based on the infection control literature related to the SARS outbreak in 2003, the greatest risk for transmission was to those with close contact, who were not properly trained in infection control procedures, and did not consistently use PPE; and that the use of N95 or higher level respirators might offer additional protection to those exposed to aerosol-generating procedures and high risk activities.  P. Ex. 73 at 18.  The CDC recommended early detection by screening for symptoms of respiratory infection and history of travel to areas with community transmission of SARS-CoV or contact with SARS-CoV patients.  The CDC recommended respiratory hygiene/cough etiquette, including placing a mask over the patient's nose and mouth and physical separation of

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patients.  The CDC recommended for the protection of healthcare workers the use of standard precautions with emphasis on hand hygiene, contact precautions with emphasis on environmental cleaning, droplet precautions (particularly if AIIR not available), and airborne precautions, including use of a fit-tested N95 or higher level respirator, and eye protection.  P. Ex. 73 at 18; CMS Ex. 42 at 156.  The CDC noted that controlling infectious diseases in long-term care facilities is challenging due to their nature, i.e., large numbers of elderly patients at increased risk live and interact together for extended periods.  Furthermore, residents are frequently transferred between long-term care facilities and hospitals, increasing the risk for infections.  The CDC states that infection control must be balanced with the psychosocial needs of residents.  P. Ex. 73 at 20.

The CDC states that hand hygiene is often cited as the single most important practice for reducing the transmission of infectious agents.  Hand hygiene includes both washing with plain or antiseptic soap and water and the use of alcohol-based hand products that do not require water.  Alcohol-based products are actually preferred over soap and water in the absence of visible soiling of hands.  P. Ex. 73 at 21.  PPE includes a variety of barriers and respirators that may be used alone or in combination, including gloves, gowns, face masks, goggles, and face shields.  If a respirator is appropriate, an N95 or higher filtration is recommended by the CDC.  The CDC notes that use of a respirator is regulated by the Occupational Safety and Health Administration (OSHA).  CDC recommends use of an N95 or better respirator by healthcare workers exposed to patients with SARS-CoV infection.  Reuse of an N95 or better respirator is acceptable to the CDC under certain conditions, including if the respirator is not damaged, soiled, or contaminated, and the fit has not been compromised.  P. Ex. 73 at 26-27.  The CDC recommends single patient rooms for patients who require contact or droplet precautions.  P. Ex. 73 at 28.  The CDC suggests that cohorting of patients and health care personnel may be useful if other infection control measures are not effective.  P. Ex. 73 at 29; CMS 43 at 104.

CDC-recommended Standard Precautions are applicable whether there is a suspected or confirmed infection, and they include:  respiratory hygiene/cough etiquette, hand hygiene, use of gloves, mask, eye protection or face shield, and safe injection practices.  The CDC states that not all precautions are necessary for all patient interactions, giving discretion to healthcare providers to determine what PPE is used.  The CDC notes that proper education and training are necessary to ensure healthcare workers make good decisions, particularly when an infectious agent, such as SARS-CoV, may not be suspected but is later identified.  The CDC notes that respiratory hygiene/cough etiquette was added due to the 2003 SARS outbreaks particularly to address undiagnosed patients (which I infer included those who are not just undiagnosed but were asymptomatic or pre-symptomatic) who enter a healthcare setting, again recognizing that transmission by pre-symptomatic or asymptomatic persons is a concern.  The elements of respiratory hygiene/cough etiquette are education, posting of signs in appropriate languages, use of

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tissues or surgical masks to cover coughs and sneezes, hand hygiene, and spatial separation of more than three feet.  P. Ex. 73 at 30-32.

Transmission-based precautions include:  (1) contact precautions, (2) droplet precautions, and (3) airborne precautions.  P. Ex. 73 at 33.

Contact precautions are intended to prevent transmission of infectious agents spread by direct or indirect contact with a patient or a patient's environment.  A single room is preferred for a patient on contact precautions and, if not available, separation of three feet or more between patients is recommended.  Healthcare workers wear a gown and gloves for all interactions that may involve contact with the patient or a potentially contaminated area in the patient's environment.  PPE is donned upon entering the patient's room and discarded before exiting.  P. Ex. 73 at 34.

Droplet precautions are intended to prevent the spread of pathogens through close respiratory or mucous membrane contact with respiratory secretions.  A single patient room is preferred for a patient who requires droplet precautions, and, if not available, separation of three or more feet and drawing the curtain between patient beds is recommended.  Healthcare workers wear a mask for close contact that is donned upon room entry.  Patients on droplet precautions should wear masks, if tolerated, when they are moved outside their room and respiratory hygiene/cough etiquette should be followed.  P. Ex. 73 at 34-35.

Airborne precautions are intended to prevent transmission of infectious agents that remain infectious over a long distance when suspended in the air.  It is preferred that patients who require airborne precautions be placed in an AIIR, which is a single room with special air handling and ventilation.  If an AIIR is not available, masking the patient, placing the patient in a private room with the door closed, and providing healthcare workers with an N95 or better respirator or masks if respirators are not available will reduce the likelihood of airborne transmission.  The respirator or mask is donned before entering the patient room.  P. Ex. 73 at 35.

The CDC states that many infections require laboratory confirmation, which may take two or more days.  Therefore, transmission-based precautions must be implemented while test results are pending based on the clinical presentation and likely pathogens.  Transmission-based precautions continue during the infectious period or the duration of the illness.  P. Ex. 73 at 35-36.

The 2007 CDC Guidelines do not refer to a screening test for SARS-CoV, and I infer that is the case because no test was developed or available.  The evidence shows and there is no dispute that testing was not done for Petitioner's residents before February 28, 2020,

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and not for the majority of Petitioner's residents until the CDC arrived at Petitioner's facility during the first week of March 2020.

17.  On January 31, 2020, the Secretary of the U.S. Health Department and Human Services (Secretary) declared a public health emergency for the U.S. due to SARS-CoV-2, but then also stated that the risk for SARS-CoV-2 in the U.S. remained low.

JANUARY 31, 2020 FEDERAL DECLARATION OF PUBLIC HEALTH EMERGENCY.  On January 31, 2020, the Secretary issued a press release discussing the declaration of a public health emergency for the U.S. due to SARS-CoV-2, effective January 27, 2020.  The Secretary stated that 2019-nCoV (subsequently named SARS-CoV-2) poses a serious threat but the risk in the U.S. remained low at the time.  The press release provides no guidance to long-term care facilities.  A copy of the actual declaration was not placed in evidence.  CMS Ex. 38.

18.  On February 5, 2020, the CDC announced that:

a.  SARS-CoV-2 is similar to the coronaviruses that cause SARS or MERS;

b.  Symptoms are fever, cough, and shortness of breath developing in two to 14 days;

c.  Older adults, those with underlying health conditions, and those with compromised immune systems are at greater risk;

d.  The Food and Drug Administration (FDA) issued an emergency use authorization on January 4, 2020, for a CDC developed test that could detect the presence of SAR-CoV-2 from respiratory samples, but it was only available in CDC laboratories (P. Ex. 5 at 4);

e.  Healthcare providers should follow guidance related to SARS and MERS;

f.  Diagnostic criteria for COVID-19 were:  (1) the aforementioned signs and symptoms, (2) travel to China, or (3) contact with one with confirmed COVID-19; and

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g.  Healthcare workers who identified a patient who met the diagnostic criteria were recommended to contact the Health Department immediately.

FEBRUARY 5, 2020 CDC ARTICLE.  The CDC publishes a "Morbidity and Mortality Weekly Report" (MMWR).  On February 5, 2020, the CDC posted an article in the MMWR about the 2019 novel coronavirus (SARS-CoV-2), which causes COVID-19.  P. Ex. 5.  The CDC stated that nine of the first 11 cases identified in the U.S. were exposed in Wuhan, China and that more U.S. cases were expected.  The article states that SARS-CoV-2 is similar to the coronaviruses that cause MERS and SARS.  Signs and symptoms of infection include fever, cough, and shortness of breath.  The CDC stated that it believed that incubation was likely two to 14 days based on experience with MERS and SARS.  Older adults and those with underlying health conditions or compromised immune systems were thought to be at greater risk.  At the time, CDC had 11 patients with confirmed COVID-19 that it was investigating.  P. Ex. 5 at 2-3.

The CDC noted that on January 10, 2020, Chinese health officials released the full SARS-CoV-2 genome sequence based on which the CDC developed a test that could diagnose SARS-CoV-2 from respiratory samples.  On January 4, 2020, the FDA granted an emergency use authorization for the CDC test.  The CDC states that as of February 5, 2020, the CDC test was limited to use in CDC laboratories, but it was working with FDA and others to expand availability of the test.  P. Ex. 5 at 4.  The CDC states that its guidance to health care providers was based on guidance for management and prevention of respiratory illnesses, including influenza, MERS, and SARS.  The CDC refers to its January 31, 2020 guidance to health care providers (which is not in evidence) that they should identify patients who might have been exposed and who have signs or symptoms of SARS-CoV-2 infection, including fever and lower respiratory tract illness (symptoms of cough or shortness of breath).  Patients were to be isolated and public health departments informed.  The CDC article states:

Criteria to guide evaluation and testing of PUIs (patients under investigation) for 2019-nCoV [SARS-CoV-2] include 1) fever or signs or symptoms of lower respiratory tract illness (e.g., cough or shortness of breath) in any person, including health care workers, who has had close contact with a patient with laboratory-confirmed 2019-nCoV infection within 14 days of symptom onset; 2) fever and signs or symptoms of lower respiratory tract illness (e.g., cough or shortness of breath) in any person with a history of travel from Hubei Province, China, within 14 days of symptom onset; or 3) fever and signs or symptoms of lower respiratory tract illness (e.g., cough or shortness of breath)

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requiring hospitalization in any person with a history of travel from mainland China within 14 days of symptom onset.  Additional nonhospitalized PUIs may be tested based on consultation with state and local public health officials.  Clinicians should evaluate PUIs for other possible causes of illness (e.g., influenza and respiratory syncytial virus) as clinically indicated.

P. Ex. 5 at 4 (footnote omitted, and emphasis added).  This CDC guidance focused on individuals with exposure to one with confirmed COVID-19 or who had traveled to China within 14 days of onset of the symptoms of fever, cough or shortness of breath.  The CDC recommended that PUIs be asked to wear a surgical mask and be directed, if possible, to a separate area at least six feet from other persons; evaluation should be in a private room with the door closed, and ideally an AIIR would be used.  The CDC recommended that healthcare personnel use standard precautions, contact precautions, airborne precautions, and eye protection such as goggles or a face shield.  Clinicians were instructed to immediately notify the public health department which would determine whether the patient who met the foregoing criteria should be considered a PUI for 2019-nCoV (COVID-19) and be tested.  However, the CDC also recommended that clinicians evaluate PUI's for other possible causes of their symptoms, such as influenza and respiratory syncytial virus.  P. Ex. 5 at 4-5.  I find the CDC guidance is clear that if healthcare workers identified a patient who met the criteria, the Health Department was to be notified.  However, if the criteria, including exposure to a confirmed COVID-19 case or travel to China or exposure to one who traveled to China, were not met, reporting to the Health Department was not recommended.  Isolation was also not recommended unless the CDC criteria were met.

This is the most current information issued by the CDC before the outbreak at Petitioner was identified.  This CDC guidance document is given the most weight in the determination of what infection control recommendations existed that Petitioner had discretion to adopt.  This document is also the weightiest evidence of the state of knowledge about COVID-19 and the information being shared with healthcare workers by the CDC at that time.  The 2007 CDC Guidelines are also given great weight.

The 2007 CDC Guidelines and the February 5, 2020 MMWR article do not mention restricting visitors to healthcare facilities or stopping the admission of new residents to long-term care facilities when there is an outbreak of SARS or MERS.

FEBRUARY 6, 2020 CMS MEMORANDUM TO STATE SURVEY AGENCIES.  On February 6, 2020, CMS issued a memorandum to "State Survey Agency Directors."  The memorandum gives no direction to state survey agency directors to forward the information to long-term care facilities.  Facilities are also not listed in the memorandum

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as being provided copies.  The memorandum states:  "[t]his policy should be communicated with all survey and certification staff, their managers, and the State/Regional Office training coordinators immediately."  P. Ex. 17 at 3; CMS Ex. 37 at 3.  No direction was given to communicate to long-term care facilities.  It is not clear how this information was intended to be disseminated to Medicare-participating entities such as Petitioner and I draw no inference that this document was distributed to Petitioner and other providers before the March 16, 2020 survey of Petitioner.  The subject is "Information for Healthcare Facilities Concerning 2019 Novel Coronavirus Illness (2019-nCoV).  The memorandum states that every participating facility must adhere to standards for infection prevention and control and refers them to CDC guidance.  This requirement is at odds with the CMS determination in 2016 not to incorporate CDC guidelines in infection control regulations and giving facilities discretion to choose the infection control guidelines they would follow.  81 Fed. Reg. 68,688, 68,807.  The memorandum states that facilities are also encouraged to take steps to prepare, including reviewing their infection control policies and practices and emergency preparedness plans.  The memorandum states that CDC advises use of standard, contact, and airborne precautions, including eye protection, and standard hand hygiene practices including alcohol-based hand sanitizer.  CMS also encouraged assessing inventories of PPE.  P. Ex. 17; CMS Ex. 37; Petitioner's Proposed Findings of Fact (PPFF) ¶ 72.  I note that CMS failed to mention that the CDC also recommended droplet precautions.  This memorandum is entitled to little weight as infection control guidance to long-term care facilities given the facts:  (1) it has not been shown that Petitioner was on notice of its contents before the survey in this case; (2) the information regarding CDC guidance is in error; and (3) the CDC February 5, 2020 MMWR was available to facilities and is the better source for accurate information as to what the CDC recommended.

19.  On February 19, 2020, the Seattle and King County Health Department Health Department announced that:

a.  COVID-19 was spreading from person-to-person in China and other countries, including the U.S.; some cases outside China were associated with travelers from China;

b.  COVID-19 has the potential to cause mild cold-like illness to severe illness and pneumonia requiring hospitalization;

c.  COVID-19 is thought to be spread by respiratory droplets from coughs and sneezes between people within six feet;

d.  Deaths were reported mainly in older adults with other health conditions;

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e.  Symptoms may appear within 2 to 14 days and include fever, cough, and difficulty breathing;

f.  Travelers to and from certain areas of the world were described as at increased risk;

g.  COVID-19 was not at that time spreading widely in the U.S.;

h.  No additional precautions were recommended for the general public;

i.  It was recommended that people follow steps similar to those used to prevent the spread of flu and the common cold, including washing hands often, avoiding touching eyes, nose, or mouth with unwashed hands, avoiding contact with sick people, staying home if sick and avoiding close contact with others, and covering one's mouth/nose with a tissue or sleeve when coughing or sneezing; and

j.  There were no vaccines or medications, but most people with mild COVID-19 should recover on their own by drinking plenty of fluids, resting, and taking medications for pain and fever.

FEBRUARY 19, 2020 COUNTY DEPARTMENT OF HEALTH PAMPHLET.  Petitioner placed in evidence a pamphlet issued by the County Health Department that was updated on February 19, 2020.  P. Ex. 25.  The pamphlet describes COVID-19 as a new virus strain spreading from person-to-person in China and other countries, including the U.S.  The pamphlet indicates that some cases outside of China have been associated with travelers from China.  The pamphlet also indicates that the virus has potential to cause severe illness and pneumonia.  The pamphlet indicates the virus is thought to spread by respiratory droplets from coughs or sneezes between people within six feet of each other.  Reported cases ranged from mild cold-like illness to severe pneumonia requiring hospitalization, with deaths reported mainly in older adults with other health conditions.  Symptoms may appear within 2 to 14 days and include fever, cough, and difficulty breathing.  Travelers to and from certain areas of the world were described as at increased risk and, while the virus was thought to originate in Wuhan, China, the disease was not specific to any ethnic group.  Travelers were recommended to follow CDC guidance.  The pamphlet states COVID-19 was not at that time spreading widely in the U.S. and no additional precautions were recommended for the general public.  However, it was recommended that people follow steps similar to those used to prevent the spread of flu and the common cold, including washing hands often, avoiding touching eyes, nose, or mouth with unwashed hands, avoiding contact with sick people, staying

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home if sick and avoiding close contact with others, and covering one's mouth/nose with a tissue or sleeve when coughing or sneezing.  The pamphlet states there are no vaccines or medications, but most people with mild COVID-19 should recover on their own by drinking plenty of fluids, resting, and taking medications for pain and fever.  It was noted that medical care or hospitalization may be required if pneumonia develops.  P. Ex. 25.  I infer, based on the fact that Petitioner placed this document in evidence, that it was known to at least some of Petitioner's staff.  Whether or not the pamphlet is correct that COVID-19 was not spreading widely in the U.S. at that time likely cannot be proved.  However, that statement in this pamphlet and the statement attributed to the Secretary that the risk remained low in the U.S. (CMS Ex. 38) certainly had the potential to give healthcare workers a false understanding of the potential risk that the CDC clearly recognized on or before February 5, 2020 (P. Ex. 5).

STATE GUIDELINES AND EMERGENCY DECLARATIONS – GUIDANCE ISSUED AFTER PETITIONER'S FIRST RESIDENT TESTED POSITIVE

20.  State and county declarations on February 29 and March 1, 2020, added no new guidance for dealing with COVID-19, but the County Health Department stated it had been responding to COVID-19 since January 21, 2020, and as of March 1, 2020, six cases of COVID-19 had been identified with one death.

FEBRUARY 29, 2020 STATE DECLARATION.  A press release placed in evidence by Petitioner shows that on February 29, 2020, Washington Governor Jay Inslee issued an emergency proclamation related to COVID-19.  The Governor encouraged people to wash their hands often, to sanitize touched surfaces frequently, and to stay home if sick.  P. Ex. 6.  This declaration was issued within 24 hours of Petitioner learning that one of its staff and a resident, both in a local hospital, tested positive for COVID-19.

MARCH 1, 2020 COUNTY DECLARATION.  King County, Washington, where Petitioner is located, issued a proclamation of emergency on March 1, 2020.  The proclamation states the County Health Department had been responding to the COVID-19 outbreak since January 21, 2020, and that as of March 1, 2020, six cases of COVID-19 had been identified with one death.  King County Health Department declared a significant health emergency due to COVID-19 effective March 1, 2020.  The proclamation contained no guidance for handling SARS-CoV-2 or its resulting illness, COVID-19.  P. Ex. 7.

STATE GUIDELINES AND EMERGENCY DECLARATIONS – GUIDANCE ISSUED AFTER THE SURVEY OF PETITIONER WAS IN PROGRESS

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21.  On March 9, 2020, the State Health Department issued guidelines that provided:

a.  COVID-19 symptoms include fever, cough, shortness of breath, and possible pneumonia, respiratory failure or none or mild respiratory symptoms;

b.  Estimated incubation was 5 days but could range from 2 to 14 days;

c.  COVID-19 testing was available for certain groups who were to be given priority;

d.  No treatment or vaccine was available;

e.  Asymptomatic spread was possible;

f.  Person-to-person transmission was likely through respiratory droplets from coughing or sneezing, or close personal contact such as shaking hands or touching contaminated surfaces;

g.  Patients with suspected and confirmed COVID-19 should stay home while symptomatic except to get medical care, separate themselves from others, avoid sharing items, and practice respiratory etiquette and frequent hand hygiene.

MARCH 9, 2020 STATE DEPARTMENT OF HEALTH GUIDELINES.  On March 9, 2020, the Washington State Health Department (State Health Department) issued COVID-19 guidelines.  Symptoms identified included fever, cough, shortness of breath, and possible pneumonia, respiratory failure or none or mild respiratory symptoms.  Estimated incubation was five days but could range from two to 14 days.  COVID-19 testing was noted to be available for listed groups who were to be given priority.  The document states no treatment or vaccine was available; asymptomatic spread is possible; person-to-person transmission was likely through respiratory droplets from coughing or sneezing, or close personal contact such as shaking hands or touching contaminated surfaces; and patients with suspected and confirmed COVID-19 should stay home while symptomatic except to get medical care, separate themselves from others, avoid sharing items, and practice respiratory etiquette and frequent hand hygiene.  P. Ex. 23 at 1.  Despite the acknowledgment that asymptomatic spread is possible, no recommendation to wear masks outside the healthcare setting was made.  This document adds nothing to the interventions recommended by the CDC.

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22.  Interventions identified by CMS in its March 13, 2020 (just before the end of the survey of Petitioner) memorandum to State Survey Agencies include many of the same interventions implemented at Petitioner in February 2020.  Specific directions from CMS were to:

a.  Restrict visitation of all visitors and non-essential health care personnel, except in a compassionate care situation, for which specific procedures were identified;

b.  Eliminate communal dining and group activities;

c.  Perform active screening of residents and staff for fever and respiratory symptoms;

d.  Remind residents to maintain social distancing and perform frequent hand hygiene;

e.  Require staff who are ill to wear a face mask and then self-isolate at home;

f.  Inform visitors in compassionate situations about hand hygiene, limiting touching of surfaces, and use of PPE (what PPE should be employed is not specified) and prohibit access by those with COVID-19 symptoms or who cannot comply;

g.  Arrange for outside services to pick up and drop off outside the facility;

h.  Consider and develop alternatives to in-person visits; and

i.  Advise anyone permitted to enter the facility to monitor for signs and symptoms of respiratory infection for at least 14 days after leaving the facility and, if symptoms occur, to self-isolate at home and contact their healthcare provider and the facility;

j.  Transfer the resident to the hospital when a higher level of care was required.

23.  CMS directed that long-term care facilities contact the state and county health departments if they observe an increase in respiratory illnesses (I infer identified by signs and symptoms), which is contrary

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to prior CDC guidance that reporting should be done if there are signs and symptoms plus travel to China or contact with a confirmed case.

24.  CMS did not recommend stopping admissions of new residents and provided that long-term care facilities could accept residents with diagnosed COVID-19, so long as the facility could implement transmission-based precautions (which transmission-based precautions, i.e., contact, droplet, or airborne, was not stated, but there is no question that most long-term care facilities did not have AIIRs necessary to meet requirements for airborne precautions).

25.  CMS recommended isolating residents received from a hospital in a separate wing or unit for 14 days.

MARCH 13, 2020 CMS MEMORANDUM TO STATE SURVEY AGENCIES.  On March 13, 2020, while the survey of Petitioner was in progress, CMS issued another memorandum to "State Survey Agency Directors."  It is not clear if this information was intended to be disseminated to Medicare-participating entities such as Petitioner and no inference may be drawn that this document was actually distributed to Petitioner and other providers.  The memorandum states:  "[t]his policy should be communicated with all survey and certification staff, their managers, and the State/Regional Office training coordinators immediately."  P. Ex. 19 at 6.  The subject was "Guidance for Infection Control and Prevention of Coronavirus Disease 2019 (COVID-19) in Nursing Homes (REVISED)."  The CMS memorandum states that nursing home facility staff should regularly monitor the CDC website for information.  The memorandum instructs that staff should contact the local health department if they suspect a resident has COVID-19.  However, the CMS memorandum lists no criteria for identifying suspected COVID-19. Facilities should consider frequent monitoring for possible symptoms of respiratory infection.  Facilities should also use CDC and CMS resources to train and prepare staff to improve infection control and prevention practices.  The memorandum does not identify any specific CDC or CMS infection control guidance.  The memorandum is specific that if a facility experiences an increased number of respiratory illnesses in patients or staff, the local or state health department should be contacted for guidance.  The memorandum is inconsistent with the CDC guidance regarding contacting the health department, which specified notification only when there were symptoms and possible exposure to COVID-19 (either through a traveler to China or one with confirmed COVID-19).  P. Ex. 5 at 4.  The memorandum does not specifically identify the baseline that should be used by a facility to determine if there is an increased number of respiratory illnesses, e.g., whether there is an increase over the number of cases from the preceding day, week, month, or year, or some other metric such as the average of such cases monthly.  Specific recommendations for long-term care facilities provided to the State Survey Agency Directors include:  restrict visitation of all visitors and non-essential health care

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personnel, except in a compassionate care situation for which specific procedures were identified; eliminate communal dining and group activities; perform active screening of residents and staff for fever and respiratory symptoms; remind residents to maintain social distancing and perform frequent hand hygiene; require staff who are ill to wear a face mask and then self-isolate at home; inform visitors in compassionate situations about hand hygiene, limiting touching of surfaces, use of PPE (what PPE should be employed is not specified) and prohibiting access by those with COVID-19 symptoms or who cannot comply; arrange for outside services to pick up and drop off outside the facility; consider and develop alternatives to in-person visits; and advise anyone permitted to enter the facility to monitor for signs and symptoms of respiratory infection for at least 14 days after leaving the facility and, if symptoms occur, self-isolate at home and  contact their healthcare provider and the facility.  CMS recommended transfer to the hospital when a higher level of care was required.  CMS stated that a nursing home may accept a resident diagnosed with COVID-19 as long as the facility could follow CDC guidance for transmission-based precautions, whether contact, droplet or airborne precautions is not stated.  CMS recommended dedicating a wing or unit exclusively for residents arriving from a hospital where they could stay for 14 days.  CMS stated nursing homes should not be cited for inadequate supplies of PPE if the shortage was outside their control, the facility was taking steps to obtain adequate supplies, and the facility was using other measures to mitigate the risk for transmission caused by the shortage.  P. Ex. 19 at 2-5.

The evidence does not show that this memorandum was actually distributed to long-term care facilities.  Therefore, it is not considered to establish standards with which facilities had to comply.  However, it is helpful to compare the guidance in the memorandum with the interventions implemented by Petitioner in February 2020 to address the unknown virus identified at that time.

26.  On March 18, 2020, the CDC published an MMWR article that addressed the findings of a team that conducted an investigation of the COVID-19 outbreak at Petitioner, which is notable for the following findings:

a.  The period analyzed by the investigation team, which was composed of representatives of the County Health Department, the local hospital, and the CDC, was February 27 to March 9, 2020.

b.  The article states that reported symptom onset dates ranged from February 16 to March 5, 2020.

c.  The article identified the following likely contributing factors:  (1) staff members who worked while symptomatic, (2) staff

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members who worked in more than one facility, (3) inadequate familiarity and adherence to standard, droplet, and contact precautions, and eye protection recommendations; (4) challenges to implementing infection control practices including inadequate supplies of PPE, hand sanitizer, and similar items; and (5) delayed recognition of cases due to low suspicion, limited testing availability, and difficulty identifying COVID-19 based on signs and symptoms alone.  I infer that item 5 is evidence that the team recognized, without specifically stating, the challenge of asymptomatic and pre-symptomatic spread.

d.  The article recognized that the county and state health departments had implemented "comprehensive prevention measures for long-term care facilities" (but did not state when) including:  (1) symptom screening and restriction of visitors and nonessential personnel; (2) active screening of healthcare personnel, including temperature and assessment for respiratory illness signs and symptoms and exclusion of staff who were symptomatic; (3) monitoring residents for symptoms; (4) social distancing, including limiting resident movements and group activities; (5) staff training on infection control and PPE use; and (6) planning to address local PPE shortages.

e.  The article recommended that once COVID-19 is found in a facility (whether confirmed or suspected is not stated), it is critical that long-term care facilities identify and exclude symptomatic staff (the impact of asymptomatic transmission was not specifically acknowledged by the investigation team); restrict visitation; and strengthen infection prevention and control guidance and adherence.

f.  The article does not specifically discuss the importance of testing to identify pre-symptomatic or asymptomatic individuals who carried and could spread SARS-CoV-2, leaving unaddressed the question of how to minimize pre-symptomatic or asymptomatic spread.

MARCH 18, 2020 CDC MMWR ARTICLE.  On March 18, 2020, after the survey was completed at Petitioner, the CDC published an MMWR article related to the COVID-19 outbreak at Petitioner.  P. Ex. 13.  This report is helpful in the analysis in this case as it permits comparison of what Petitioner's staff actually did before and at the beginning of the outbreak with the CDC recommendations developed, at least in part, based on the

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outbreak of COVID-19 at Petitioner.  The information for the article is credited to the COVID-19 investigation team that included representatives of the County Health Department, Evergreen Health (the public hospital near Petitioner to which many residents were sent), and the CDC.  P. Ex. 13 at 3.  The period analyzed by the investigation team was February 27 to March 9, 2020.  The article states, based on its analysis, that reported symptom onset dates ranged from February 16 to March 5, 2020.  P. Ex. 13 at 2.  The investigation team identified eight other skilled nursing and assisted living facilities in King County, the county where Petitioner is located, that had one or more confirmed COVID-19 cases.  P. Ex. 13 at 2.  The investigation team identified the following likely contributing factors:  (1) staff members who worked while symptomatic, (2) staff members who worked in more than one facility, (3) inadequate familiarity and adherence to standard, droplet, and contact precautions, and eye protection recommendations; (4) challenges to implementing infection control practices including inadequate supplies of PPE, hand sanitizer, and similar items; and (5) delayed recognition of cases due to low suspicion, limited testing availability, and difficulty identifying COVID-19 based on signs and symptoms alone.  I infer that item 5 is evidence that the authors of the article recognized, without specifically stating, the challenge of asymptomatic and pre-symptomatic spread.  P. Ex. 13 at 2.  The investigation team recognized that the county and state health departments had implemented "comprehensive prevention measures for long-term care facilities" including:  (1) symptom screening and restriction of visitors and nonessential personnel (this is the first evidence in this case that the CDC recognized that restricting visitors and nonessential personnel was a good idea ); (2) active screening of health care personnel including temperature and assessment for respiratory illness signs and symptoms and exclusion of staff who were symptomatic; (3) monitoring residents for symptoms; (4) social distancing including limiting resident movements and group activities; (5) staff training on infection control and PPE use; and (6) planning to address local PPE shortages.  The investigation team does not state when the state and county announced and recommended implementation of the interventions.  The investigation team recommended that once COVID-19 is found in a facility (whether confirmed or suspected is not stated), it is critical that long-term care facilities identify and exclude symptomatic staff (the impact of asymptomatic transmission was not specifically acknowledged by the investigation team); restrict visitation; and strengthen infection prevention and control guidance and adherence.  P. Ex. 13 at 2.  The investigation team's recommendations did not identify the importance of testing to identify asymptomatic individuals who carried and could spread SARS-CoV-2, based on which I infer that the investigation team did not appreciate the possible significant impact of asymptomatic transmission.  Similar findings and recommendations were reported in the New England Journal of Medicine on March 29, 2020.  P. Ex. 14.  However, this article acknowledges the importance of

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asymptomatic and pre-symptomatic spread and the need for testing for SARS-CoV-2.25   P. Ex. 14 at 6.

The impact of asymptomatic and pre-symptomatic spread was addressed in a March 27, 2020 MMWR based on data from another facility which follows.

MARCH 27, 2020 CDC MMWR.  In the March 27, 2020 MMWR, the CDC reported about the case of a SNF other than Petitioner.  According to the CDC, 16 days after SARS-CoV-2 was first identified in the SNF, 76 of 82 residents were tested for SARS-CoV-2, 23 (i.e., 30.3 percent) tested positive and approximately half were asymptomatic or pre-symptomatic on the day of testing.  The CDC found that asymptomatic and pre-symptomatic persons who are not isolated can spread SARS-CoV-2.  The CDC stated that symptom-based screening may fail to identify as many as half of residents with SARS-CoV-2 infections.  In light of this fact, the CDC conceded that failure to isolate those residents who were asymptomatic or pre-symptomatic may have contributed to the spread of SARS-CoV-2.  Therefore, the CDC recommended that once a case of COVID-19 is identified in a SNF (whether a confirmed case or suspected case is not specified), all residents should be tested, and the results of testing should be done to guide cohorting strategies.  However, if testing is not available, all residents should be placed on transmission-based precautions with, if necessary, extended use and reuse of recommended PPE.  P. Ex. 15 at 3.  The CDC recommended that during the COVID-19 pandemic, SNFs should restrict visitors (except for compassionate care situations), restrict nonessential personnel from entering the building, ask staff to monitor themselves for symptoms, screen all staff members at the beginning of the shift for fever and symptoms, and support staff sick leave, including for those with mild symptoms.  P. Ex. 15 at 4.  Based on the evidence before me, this is the first time that the CDC recommended restricting visitor and nonessential personnel from entering a facility.  The CDC stated further that once a case of COVID-19 is identified in a SNF, resident-to-

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resident interactions should be restricted, all health care personnel (I infer the intent is all staff) should wear face masks while in the facility, and PPE (gown, gloves, eye protection), and an N95 respirator (or face mask if an N95 not available) should be used while caring for residents.  Strategies for extended PPE use and reuse are necessary when PPE is limited.  Finally, the CDC stated that, as testing became more available, it may be used to identify residents with SARS-CoV-2 infection to permit cohorting in either designated units or a separate facility.  P. Ex. 15 at 4.

On April 24, 2020, the results and findings of a study of one SNF other than Petitioner, published in The New England Journal of Medicine, were similar to those reported in the March 27, 2020 MMWR, i.e., more than half the residents who tested positive for SARS-CoV-2 were either asymptomatic or pre-symptomatic.  The conclusion was that infection control strategies focused solely on symptomatic residents were insufficient to prevent SARS-CoV-2 transmission after introduction into a SNF.  P. Ex. 16 at 1-2, 9.  The authors commented that "[e]arly recognition of initial SARS-CoV-2 introduction combined with early interventions in all units might prevent spread within a facility."  P. Ex. 16 at 9-10 (emphasis added).  The authors did not provide insight as to how early detection might be accomplished, other than perhaps by testing.  One conclusion was that the use of face masks for all healthcare workers (and I infer this includes other staff, such as housekeeping, maintenance, and others) in long-term care facilities is clearly supported given the potential for transmission by those who are pre-symptomatic or mildly symptomatic.  P. Ex. 16 at 10.  It is not clear why the authors did not specifically mention staff who were possibly asymptomatic, but the use of "all" should be read literally to include all staff in my layperson's opinion.  The authors noted that the elderly often manifest few or atypical symptoms, which can delay diagnosis and contribute to transmission.  The authors also noted that cohorting based on symptoms may increase the risk for transmission of SARS-CoV-2 because the study showed that typical symptoms associated with COVID-19 were common even among residents who tested negative for SARS-CoV-2.  The authors state that data supports not discontinuing transmission-based precautions in a SNF, unless a test-based strategy for determining infection rather than a symptom-based strategy is used.  P. Ex. 16 at 10.  It was recommended to use testing to determine whether to use transmission-based precautions, isolation, and cohorting strategies.  P. Ex. 16 at 10-11.  I infer that the authors intended that transmission-based strategies be used for all in the absence of testing.  The authors recommend:  restricting visitors and nonessential personnel from entering a facility, requiring use of face masks by all staff while in the facility, and implementing screening of staff (whether by testing or symptom screening is not specified).  Once SARS-CoV-2 is in a facility, PPE (when available) should be used during all resident care activities regardless of symptoms.  The authors conclude that testing for SARS-CoV-2 should be used for excluding infected staff and cohorting residents either in separate units in the facility or in a separate facility designated for those with COVID-19.  P. Ex. 16 at 11.

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APRIL 2, 2020 CMS MEMORANDUM – "COVID-19 LONG-TERM CARE FACITLIY GUIDANCE."  On April 2, 2020, CMS issued a document titled "COVID-19 Long-Term Care Facility Guidance."  P. Ex. 21.  I note this document was issued almost a month after the survey of Petitioner was completed.  The document states it issues new guidance related to COVID-19.  Therefore, this guidance, while not applicable to Petitioner in February and early-March, is also worthwhile for comparing with what Petitioner did at that time to address an outbreak of an unknown infection, which subsequently was identified as COVID-19.

The document contains many recommendations, some of which are included here.  The document notes that on March 13, 2020, a general prohibition on visitors in nursing homes was implemented as well as strict infection control and screening recommendations.  The source of the prohibition is not stated.  The document recommends that long-term care facilities immediately ensure that they are complying with CMS and CDC infection control guidance, including hand hygiene, use of a CMS- issued infection control self-assessment checklist, following CDC guidance to long-term care facilities on COVID-19 and guidance on conservation of PPE.  The document encouraged state and local leaders to work with long-term care facilities to address PPE and COVID-19 testing needs.  The document requires long-term care facilities to immediately implement symptom screening for all entering a facility (except emergency medical services personnel (EMS)), including taking the person's temperature and asking about symptoms.  Every resident should be assessed for symptoms and have their temperature checked daily.  Testing should be used if available.  Facilities are required to ensure staff use PPE, if available, when interacting with residents, consistent with CDC guidance on conservation of PPE.  All long-term care facility personnel should wear a face mask while in the facility.  Full PPE should be worn when caring for a resident with known or suspected COVID-19 and full PPE should be worn when caring for all residents whether or not diagnosed with COVID-19, if there is an occurrence of transmission in the facility.  Residents who must regularly leave the facility for care should wear a facemask when out of their room.  Residents, whether or not they have symptoms, should cover their noses and mouths when staff is in their room, but should not use medical facemasks, unless they are COVID-19 positive or assumed to be positive.  Facilities should use separate staff to care for those who are COVID-19 positive when possible, and cohorting on a separate unit or in a separate facility should be done when possible.  However, facilities should use consistent staffing for residents when possible regardless of symptoms or COVID-19 status, i.e. staff should not work across units or floors.  Staff should be trained to be familiar with the signs and symptoms of COVID-19.  Long-term care facilities should notify residents and families of limitations on access to residents and the ability to leave and re-enter the facility.  P. Ex. 21.

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STAFF, MEDICAL DIRECTOR/PRIMARY CARE PHYSICIAN, AND PHYSICIAN ASSISTANT TESTIMONY – EVENTS RELATED TO THE OUTBREAK AT PETITIONER IN FEBRUARY AND MARCH 2020.

Petitioner's staff, including the infection control nurse, Petitioner's medical director, Petitioner's director of nursing (DON), Petitioner's administrator, and a physician's assistant who was not part of Petitioner's staff but was involved in care of approximately 90 percent of Petitioner's residents, provide a detailed perspective of what occurred in the facility in February and March 2020.  Some of them were very emotional when testifying about the events and deaths.  All were credible, and unless otherwise indicated, all their testimony is considered worthy of weight.  The fact that the witnesses were employees of the facility or, in the case of PA Carmichael, worked for Dr. Kumar in his capacity as a private physician rather than in his capacity as Petitioner's medical director, does not detract from the credibility of these witnesses.  The witnesses testified forthrightly and there was no indication of exaggeration, fabrication, or other indication that their testimony was less than fully credible.  Although the two federal surveyors were also in the facility from March 6 through 8, 2020, they were not directly involved in patient care or decision-making that affected the quality of care and implementation of infection control measures.  Therefore, their testimony about anything other than their direct observations is based on their perception of statements by staff (who were significantly stressed by the situation at Petitioner or who were sick with COVID) or were based on the surveyors' interpretation of records they reviewed without direct observation of the events recorded.  Therefore, the surveyors' version of that which they did not directly observe is not as weighty regarding actual events as the testimony of Petitioner's staff who testified.

27.  LPN Alice Cortez was Petitioner's infection control nurse during February and March 2020, and she had been in that position for nearly five years.  Tr. 634-35, 993.

28.  In January through February 19, 2020, LPN Cortez identified no outbreak that required reporting to the County Health Department under guidance issued by that department or the State Health Department (P. Ex. 22).  Tr. 635-36, 638-39, 643-46; P. Ex. 33.

29.  September through March is cold and flu season (flu season) where Petitioner is located and flu, pneumonia, and upper and lower respiratory infections are expected annually, usually with an increase of cases in February.  Residents are monitored for fever, sneezing, coughing, cold symptoms, and shortness of breath.  During flu season, if a resident presents with respiratory symptoms, a flu protocol (P. Ex. 30 at 42-44) is followed that involves doing a virus panel and a rapid flu

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test and if that test is negative, a chest x-ray is done to assess for pneumonia; transmission-based precautions are implemented if the resident has a fever and cough; and universal (standard) precautions are implemented for those with only a fever; the resident is placed in isolation in a single room with a private bath and if a single room is not available, cohorting is used.  As early as January 2020, residents were isolated in private rooms under Petitioner's flu protocol, but staff was not required to use PPE in the isolation rooms at that time.  Tr. 636-42.

30.  Between February 19 and 26, 2020, an unusual number of respiratory infections were observed, and flu tests were being reported as negative, which was unusual according to PA Carmichael.  Line listings show the onset of respiratory symptoms for residents around February 18 and 19, 2020, and for staff as early as February 12, 2020.  Tr. 584-89, 591-95, 646-47.

31.  On February 24, 2020, LPN Cortez contacted the County Health Department for guidance, and she was advised by email that she would receive a response as quickly as possible.  The email provided a list of internet links to resources.  P. Exs. 27; Tr. 652 702.

32.  On February 26, 2020, LPN Cortez consulted with PA Carmichael and Dr. Kumar and they decided that LPN Cortez should call the County Health Department because they had a number of residents with a fever and a negative flu test and they could not determine a diagnosis.  LPN Cortez did not call the County Health Department to notify the department of an outbreak of infection prior to February 26, 2020, because she was waiting to see if antibiotics prescribed before that date would be effective and it was not until the morning of February 26, 2020, that she had a significant number of residents (nine) reported to have new fevers and negative flu tests.  Tr. 650-51, 667-74, 680-87, 694, 702; P. Ex. 39.

33.  On February 26, 2020, LPN Cortez called the County Health Department but was unsuccessful reaching anyone at the County Health Department who could assist her.  Tr. 654-55.

34.  LPN Cortez called the County Health Department again on February 27, 2020, and she subsequently received a call-back around noon on February 27, 2020.  During the call LPN Cortez described the interventions implemented at Petitioner to address the outbreak of the unknown infection, and the Health Department representative

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recommended three additional interventions:  use of disposable utensils for dining, limiting admissions, and implementing droplet precautions.  Tr. 655-56, 678-80; P. Ex. 38 at 2.

35.  Interventions LPN Cortez, Dr. Kumar, and PA Carmichael agreed should be implemented on February 26, 2020, included:  initiating the respiratory virus protocol (P. Ex. 30 at 43-44) with standing orders for rapid flu and laboratory testing; closing the dining area and serving residents in their rooms; terminating group activities and therapy in favor of providing activities and therapy in resident rooms; wiping down common areas and the gym with bleach; informing the County Health Department by telephone; notifying the medical director and Administrator; initiating daily surveillance of residents; educating staff about respiratory virus signs and symptoms, prevention of transmission, hand hygiene, and PPE; and continuing to offer the flu vaccine to staff and residents.  The use of disposable utensils was also implemented.  P. Exs. 28, 36, 38, 39; Tr. 659, 664-65.  

36.  As of February 10, 2020, respiratory screening and questionnaires were being completed for all visitors, vendors, and volunteers.  Signs were posted reminding visitors not to visit if they had a fever or cough, to wash or sanitize their hands upon arrival and before leaving or if they cough or sneeze, to cough or sneeze in a tissue or their sleeve, and directing visitors to ask for a mask if they were ill and had to visit.  Similar signs were posted for staff.  Staff were observed during daily meetings and throughout the day for signs of illness and rapid flu tests were used with some staff.  P. Exs. 32, 34, 35, 38; Tr. 662-64.

37.  On February 26, 2020, Petitioner's DON and LPN Cortez issued a memorandum to all staff.  The memorandum states that due to the increased number of respiratory symptoms, the following precautions would be implemented immediately:  the dining room would be closed with meals in resident rooms except for residents who needed feeding assistance; hold off on group activities; therapy to be done in resident rooms especially if the resident had respiratory symptoms; all common areas and gym equipment were to be sanitized with bleach; staff with fever, cough, body aches, and malaise were to stay home and see their medical provider; hand hygiene was to be done before and after patient care; influenza protocol was to be implemented if medically indicated; and the flu vaccine would continue to be offered to residents and staff.  P. Exs. 36, 38.

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38.  On February 26, 2020, LPN Cortez posted a sign in the lobby that stated no visitors were allowed.  LPN Cortez also advised the receptionist to inform residents' families and visitors of the outbreak.  P. Ex. 39.  The evidence does not show that restricting visitors was specifically discussed by LPN Cortez, Dr. Kumar, and the DON, and it does not appear in the memorandum issued by LPN Cortez and the DON.  However, I infer that action was consistent with and intended as one of the infection control interventions.

39.  Following the meeting of LPN Cortez, Dr. Kumar, and PA Carmichael and the decision to declare a respiratory outbreak on February 26, 2020, LPN Cortez noted that a Mardi Gras party was scheduled that afternoon with a musical group that she believed was already on the way to Petitioner.  The party was allowed to proceed.  LPN Cortez testified that distancing was observed.  P. Ex. 1 at 47.  Allowing the party to proceed was contrary to the decision to address the outbreak by eliminating group activities; restricting residents to rooms for therapy, activities, and meals; and closing the facility to visitors.  Allowing the party to proceed was also contrary to Petitioner's protocol for managing a flu outbreak, which requires that group activities be stopped.  Petitioner's policy makes no exception even if social distancing is observed.  P. Ex. 30 at 43.

40.  According to PA Carmichael, on about February 4, 2020, she noticed a pattern of infections developing but she did not suspect COVID-19 because the CDC had not alerted them to the possibility.  On February 20, 2020, she first spoke to LPN Cortez and Dr. Kumar about a possible outbreak at Petitioner because she believed the symptoms that she was seeing were not due to the flu and might have been related to colds or some new virus other than COVID-19.  On February 26, 2020, she noticed that the rate of infection in the facility was increasing.  She also noticed that residents were declining and had to be sent to the hospital for a higher level of care than could be provided at Petitioner.  PA Carmichael testified credibly that at that time she suspected possible COVID-19 infection was likely.  She noticed that residents were decompensating quickly about the time that Petitioner was notified on February 28, 2020, that a hospitalized resident had tested positive for COVID-19.  Tr. 587-89, 591-95, 614-17, 619-20.

41.  Dr. Kumar testified credibly that around February 19 through 22, 2020, he became concerned based on Petitioner's infection line listing

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(CMS Ex. 6 at 3-5) about the number of cases of pneumonia and lower respiratory infections and shortly thereafter, the call was made to the Health Department.  Tr. 1022-27.

42.  On February 28, 2020, Petitioner cancelled nursing student clinical rotations at Petitioner.  P. Ex. 37.

43.  On February 28, 2020, LPN Cortez filed a report with the State Health Department.  P. Ex. 28; Tr. 652-58.

44.  On February 28, 2020, Petitioner's management was advised that a hospitalized resident tested positive for COVID-19.  Tr. 658; P. Ex. 39 at 2.

45.  PA Carmichael continued to communicate with and receive guidance from Dr. Kumar, even after he could no longer enter the facility after February 28, 2020, because he had COVID-19.  Dr. Kumar did not designate an alternate physician at that time.  However, Dr. Kumar testified credibly that if PA Carmichael could not reach him, she was to call Dr. Sahi.  Tr. 1035-37.

46.  PA Carmichael testified credibly that between February 28 and March 7, 2020, she was assessing residents and sending them to the hospital almost every hour; no resident that needed to go to the hospital did not go, except those who asked not to go.  However, at one point the emergency room sent residents who had COVID-19 symptoms back to the facility because the emergency room refused to accept more patients.  Tr. 595-600.

47.  PA Carmichael continued to work in the facility daily from February 28 to March 7, 2020, when she developed COVID-19 symptoms.  PA Carmichael testified that she believed that a doctor or doctors from the local hospital came to assist at Petitioner after she became sick on about March 8, 2020.  Tr. 595-600, 602-03, 626-27.

Alice Cortez, LPN, is Petitioner's infection control nurse.  Tr. 634-35, 993.  LPN Cortez testified that she worked for Petitioner and was the Infection Control Preventionist for five years with responsibility for infection surveillance; training staff, including the use of PPE; implementing infection control protocols; TB assessment and testing; and all matters related to infection control.  Tr. 634-35.

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LPN Cortez testified that if there is an outbreak in the facility, which she defined as one laboratory confirmed case of influenza (flu) or two or more acute febrile (i.e. with fever) respiratory illnesses within a week, the Health Department 26 is contacted.  Tr. 635-36.  Referring to P. Ex. 22, a list of reportable diseases in Washington, she testified that pneumonia is not listed as being reportable.  Tr. 643.  LPN Cortez testified that at no time in January 2020 through February 19, 2020, did she identify that there was an outbreak in the facility that had to be reported.  Tr. 638, 644-46.

According to LPN Cortez, flu season (including influenza A and B and other respiratory diseases) runs from October to late February each year in the area where Petitioner is located, usually with an increased number of cases in February.  Tr. 636-37.  She testified that when a resident presents with respiratory symptoms in the winter, there is an influenza protocol that involves doing a rapid influenza test; physician notification; if the influenza test is negative, a chest x-ray is done to assess for pneumonia; transmission-based precautions are implemented if the resident has a fever and cough; and universal precautions27 are implemented for those with only a fever.  A resident with respiratory symptoms is placed in isolation in a single room with private bathroom.  If no private rooms are available, patients with similar symptoms are put in the same room, i.e. cohorting.  She testified that they would also keep the curtain between beds closed to provide a barrier between residents when no private room was available.  Tr. 637-42.

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LPN Cortez testified that she started seeing an unusual number of respiratory infections around February 26, 2020.  Tr. 646-47.  Referring to P. Ex. 33 (Petitioner's infection line list she created), LPN Cortez testified that beginning in January through the middle of February, all influenza tests were reported to be negative.  Tr. 639.  She testified based on P. Ex. 33 at 4-5, that she saw no outbreak indicated on the line list before February 19, 2020.  Tr. 644-45.  Referring to P. Ex. 33, she testified that around February 19 or 20, 2020, she started seeing more respiratory illness and pneumonia.  She testified she discussed her observations with Dr. Kumar and PA Carmichael.  Tr. 646-47.  She was aware of no guidance from the CDC or the State of Washington to be on the lookout for COVID-19.  Tr. 647.  Therefore, on February 24, 2020, she contacted the County Health Department for guidance.  Tr. 647.  She was advised by email dated February 24, 2020, that she would be called, and the email listed links to information from Washington State, King County, and the CDC (P. Exs. 26, 27; Tr. 652, 702).  On February 26, 2020, LPN Cortez called the County Health Department because she was told by a charge nurse that a number of residents had a fever.  LPN Cortez directed that rapid flu tests be done, and the results of the tests were all negative.  She then consulted with PA Carmichael and Dr. Kumar.  The decision was made to call the Health Department to report increased respiratory symptoms because they had residents with acute fever but negative flu tests, and they could not determine a diagnosis.  She called the Health Department again on February 27, 2020.  She testified she was told no investigator had yet been assigned and that she would be called.  She received a call back around noon on February 27, 2020, from a Health Department investigator.  She testified that she told the investigator about the increased number of respiratory illnesses and the interventions Petitioner had implemented.  LPN Cortez testified that the investigator told her Petitioner was doing all that they should and suggested only using disposable plates and utensils.28   She testified she sent the investigator a line listing (P. Ex. 29) on February 27, 2020, as the investigator requested.  She then reported new cases to the investigator every day.  However, no new direction or guidelines was received from the health department.  Tr. 650-51, 653-57, 678-80, 702; P. Ex. 38.  LPN Cortez testified that she was told by the health department that flu precautions should be followed because COVID-19 symptoms were like the flu.  She testified that she received no information about the spread of COVID-19 by asymptomatic people until later.  Tr. 662-63, 702.

The line listing LPN Cortez sent the Health Department on February 27, 2020, was a form titled "Line List for Outbreaks in Long Term Care Facilities," a Health Department form.  P. Ex. 29, Tr. 656, 676.  In response to my questioning, LPN Cortez testified that P. Ex. 29 is a listing of all sick people at Petitioner and it is created only when there is a

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suspicion of or a confirmed outbreak.  Tr. 684-86.  The first entry in the report shows an onset of fever in a resident on February 26, 2020, and the report lists a total of nine resident cases involving an onset of fever on February 26, 2020.  One of the nine residents also had shortness of breath.  Another resident had low blood oxygen level, with an onset date of February 26, 2020.  The earliest onset dates listed are February 18 and 19, 2020, and both residents are listed as having a low blood oxygen level (hypoxia).  P. Ex. 29 at 2-3.  The line listing for staff shows a laundry worker developed respiratory symptoms as early as February 12, 2020, with additional staff showing respiratory symptoms on February 19 and 21, 2020.  Onset dates of fever in staff are listed as February 15, 16, 19, 24, and 28, 2020.  P. Ex. 29 at 4-6.  LPN Cortez testified that February 26, 2020, was the first day she saw that there were so many residents with fever and a negative flu test.  Tr. 694.

LPN Cortez explained the line listing in evidence as P. Ex. 33 (a facility document titled "Infection Control Report") listed only residents with a diagnosis and ordered treatment.  Tr. 674, 684.  P. Ex. 33 lists three cases of pneumonia with orders for antibiotics on February 19, 2020; a lower respiratory infection with an order for antibiotics on February 20, 2020; two cases of pneumonia with antibiotics ordered on February 21, 2020; a lower respiratory infection with an order for antibiotics on February 22, 2020; two cases of pneumonia on February 23, 2020, with antibiotics ordered; and no cases were listed on February 24, 25, or 26, 2020.  P. Ex. 33 at 5-6.  I infer from LPN Cortez's testimony (Tr. 674-76, 684-87) that an undiagnosed, symptomatic illness was simply not listed on the line listing marked P. Ex. 33.  LPN Cortez explained that P. Ex. 33 is used for Petitioner's antibiotic stewardship program and is intended to ensure Petitioner uses antibiotics appropriately.  Tr. 676, 684.

In response to my questions, LPN Cortez testified that she did not contact the County Health Department on February 19, 2020, because she was not at work that day.  She did not know why the DON, who acted as her backup infection control preventionist, did not contact the County Health Department on February 19, 2020.  She testified that she called the County Health Department on February 26, 2020, because two nurses reported a number of acute fevers, even though those residents had not been diagnosed and did not appear on her line listing (P. Ex. 33 at 5-6) on February 26, 2020.  She testified that she did not contact the Health Department before February 26, 2020, because she was waiting to see if prescribed antibiotics would be effective.  She also testified that pneumonia and lower respiratory infections were not required to be reported to the Health Department.  She explained that she did not file her on-line report with the State Health Department until February 28, 2020, because she was waiting for a call back and instructions from the County Health Department.  She testified that it was facility practice to call the County Health Department every time there was a suspicion of or a confirmed outbreak.  Tr. 667-74, 680-87.

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LPN Cortez testified to other interventions that were implemented at Petitioner.  As of February 26, 2020, respiratory screening and questionnaires were being completed for all visitors, vendors, and volunteers.  P. Ex. 38, Tr. 660-61.  Use of the form began on about February 10, 2020.  P. Ex. 32.  Petitioner had also posted signs normally used all year that directed that visitors not visit if they have a fever or cough, to get a flu vaccination, to wash or sanitize hands upon arrival and before leaving or if they cough or sneeze, to cough or sneeze in a tissue or their sleeve, and directed visitors to ask for a mask if ill and they had to visit.  P. Ex. 34, Tr. 661-62.  Similar signs were posted for staff.  Staff were observed during daily meetings and throughout the day for signs of illness, and a rapid flu test was used with some staff.  P. Ex. 35, Tr. 663-64.  LPN Cortez testified that she cancelled the clinical rotation for nursing students on about February 26, 2020, but that actually occurred on February 28, 2020, according to copies of email in evidence.  Tr. 665-66, P. Ex. 37.  LPN Cortez identified her recording of her actions and events in the facility beginning as early as October 2019 but focused more specifically on the period February 26 through 29, 2020.  P. Ex. 39, Tr. 666.

LPN Cortez identified P. Ex. 28 as her February 28, 2020 online report to the State Health Department.  Tr. 652-53.  Her report lists interventions implemented as of February 26, 2020, including initiating respiratory virus protocol and standing order for rapid flu and laboratory testing; closing the dining area and serving residents in rooms; terminating group activities and therapy in favor of resident room treatment; wiping down common areas with bleach; informing the Health Department by telephone; notifying the medical director and administrator; initiating daily surveillance of residents; educating staff about respiratory virus signs and symptoms, prevention, and hand hygiene and use of PPE; and continuing to offer flu vaccine to staff and residents.  P. Exs. 28, 36 (memorandum to staff dated February 26, 2020), 38; Tr. 659, 664-65.

LPN Cortez testified that around midnight on February 28, 2020, she learned that a hospitalized resident tested positive for COVID-19.  At about 1:00 a.m. on February 29, 2020, there was a meeting of staff on duty at which Petitioner's Vice President and Regional Nurse explained that there was a confirmed case of COVID-19.  A PPE cart was placed in the hall and supplies were checked.  One staff member was sent home due to illness.  Tr. 658-59.

LPN Cortez testified during the state administrative proceeding that the emergency meeting she had with PA Carmichael and Dr. Kumar ended about noon on Wednesday, February 26, 2020.  She noticed about that time that the Mardi Gras party was scheduled that afternoon and that a musical group was already on the way to the facility.  Despite the decision of LPN Cortez and Dr. Kumar to end group activities and keep residents in their rooms, the party was allowed to proceed.  LPN Cortez testified that distancing was required but she did not explain what that meant.  P. Ex. 1 at 47 (state transcript p. 190 lns. 3-23); Petitioner's Prehearing Brief at 21.

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P. Ex. 39 is LPN Cortez's chronology of events.  The chronology is undated.  She testified that she prepared the chronology but did not say when.  Tr. 666.  The document has not been challenged by CMS and it is consistent with her testimony.  I accept the chronology as a credible recording of her recollection of events made sometime on or after February 29, 2020, the last date for which events are recorded.  The chronology shows that on February 26, 2020, when multiple residents had elevated temperatures, respiratory symptoms, and negative rapid flu tests, LPN Cortez and PA Carmichael decided to announce a respiratory viral outbreak.  The DON and Administrator were notified of their decision.  LPN Cortez conducted an immediate meeting with all department heads on February 26, 2020, and announced the following interventions:  close the dining area and serve meals in rooms; cancel group activities; conduct therapy in resident rooms; wipe common areas with bleach; increase cleaning; use PPE and hand hygiene; encourage the flu vaccine; and instruct staff to stay home if ill.  LPN Cortez also initiated on February 26, 2020, a surveillance list for residents with flu-like symptoms.  P. Ex. 39 at 1.  LPN Cortez states in the chronology that she called the department of health (I infer the County Health Department) and was told that she would be called back within 24 hours.  The document states that she reported to the State Health Department online on February 26, 2020 (P. Ex. 39 at 1), but that is clearly an error because the report to the state shows that it was actually submitted on February 28, 2020.  P. Ex. 28 at 2.  LPN Cortez recorded that on February 26, 2020, she placed a sign in the lobby that stated no visitors are allowed and gave direction to the facility receptionist to inform family and visitors of the outbreak.  She also placed a sign in the staff break room regarding the outbreak; checked PPE supplies and requested that more PPE be ordered; and she notified the nursing students' clinical instructor that rotations were cancelled.  On February 27, 2020, she called the Health Department again and was told that she would be called back.  The County Health Department representative called back around noon on February 27, 2020.  The chronology shows that LPN Cortez and the representative discussed interventions implemented on February 26 and the representative agreed with the interventions and suggested only that disposable utensils be used.  P. Ex. 39 at 1-2.  (LPN Cortez's handwritten, contemporaneous notes dated February 27, 2020, actually reflect three recommendations:  use disposable utensils, limit admissions, and implement droplet precautions.  P. Ex. 38 at 2.  On February 28, 2020, a County Health Department representative informed LPN Cortez that one of Petitioner's residents hospitalized at Evergreen Hospital would be tested for COVID-19.  At about 1:00 a.m. on February 29, 2020, it was reported to LPN Cortez by Petitioner's Vice President and Regional Nurse that the tested resident was positive for COVID-19.  Staff was directed to review infection control prevention procedures, the use of PPE, and hand hygiene; the PPE cart was placed in the facility hallway; and PPE supplies were inventoried.  LPN Cortez recorded in her chronology that she was out of the facility due to sickness from March 4 through 22, 2020.  LPN Cortez's chronology also reflects that in October 2019, she offered and provided flu vaccine to residents and staff; in January 2020, she posted a sign on the facility front door about preventing the spread of the flu; in February 2020, she

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started respiratory assessment questionnaires for all visitors, families, and students; sent two nursing students home because they had a cough; informed two dietary aides to isolate for 10 days and monitor their temperature and for respiratory symptoms after their return from travel to the Philippines and Korea; encouraged staff who called in sick with flu-like symptoms to see their primary care physician and get an influenza test; and emailed the corporate director of respiratory therapy regarding a coronavirus protocol for Petitioner.  P. Ex. 39 at 2-3.

On February 26, 2020, Petitioner's DON, Bill Gruschow, and LPN Cortez issued a memorandum to all staff.  The memorandum states that due to the increased number of respiratory symptoms, the following precautions would be implemented immediately:  the dining room would be closed with meals in resident rooms except for residents who needed feeding assistance; hold off on group activities; therapy to be done in resident rooms, especially if the resident had respiratory symptoms; all common areas and gym equipment were to be sanitized with bleach; staff with fever, cough, body aches, and malaise were to stay home and see their medical provider; hand hygiene was to be done before and after patient care; influenza protocol was to be implemented if medically indicated; and the flu vaccine would continue to be offered to residents and staff.  P. Exs. 36, 38.

LPN Cortez testified that she became ill on March 4, 2020.  Tr. 645, 660.  LPN Cortez testified that the director of nursing became sick on February 26 or 27, 2020, and he was subsequently diagnosed with COVID-19 and never came back to the facility.  Tr. 665.  LPN Cortez testified that she did not tell the surveyors that she saw an increase in respiratory symptoms starting February 12, 2020, noting she was home sick with COVID-19 with no documents when she was interviewed by surveyors by telephone.  She had no recollection of what was happening on February 12, 2020.  Tr. 646.

I find that LPN Cortez's testimony is consistent with the evidence of record, unrebutted, and fully credible.

Ngim (Christy) Carmichael, PA, is Dr. Kumar's employee and she saw Petitioner's residents who were Dr. Kumar's patients, subject to his supervision and direction.  Tr. 581-82, 993; PPFF ¶¶ 38-41.  PA Carmichael is not an employee of Petitioner.  However, she worked at Petitioner's facility, seeing and treating Dr. Kumar's patients four days each week and she was on call 24 hours, unless Dr. Kumar took calls.  She testified that under Washington law she could assess patients as Dr. Kumar could and he did not need to be physically present when she did assessments.  Sometimes she did rounds with Dr. Kumar.  She spoke with Dr. Kumar every day.  If Dr. Kumar was not available, then she consulted with Dr. Sahi.  Tr. 580-82.  She testified that she saw Dr. Kumar's patients at Petitioner for four or five years prior to 2020.  Tr. 584.

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PA Carmichael testified that September through March or mid-April is cold and flu season where Petitioner is located, during which flu, pneumonia, and upper and lower respiratory infections are expected annually.  During that period, Petitioner is monitoring residents for fever, sneezing, coughing, cold symptoms, and shortness of breath.  If any of these symptoms are observed, the protocol is to do a rapid flu test and a virus panel.  She testified that if a patient has a fever, she typically orders laboratory tests and if they have a cough, fever, and/or shortness of breath, she orders a chest x-ray to rule out pneumonia  She testified that in January to about mid-February 2020, she noticed that all rapid influenza tests were reported as negative, which was unusual as she would normally have one or two patients test positive for flu.  In early February 2020, she discussed the situation with LPN Cortez and the decision was made that staff were to be alerted and any staff with symptoms were to wear a mask, and those with a fever were to go home and see their primary care doctor.  She testified that before February 19, 2020, she did not associate her observations with COVID-19.  PA Carmichael testified that she noted many admissions of new residents arriving from local hospitals with the same symptoms, a negative flu test, and on antibiotics and oxygen.  PA Carmichael testified that toward the end of February 2020, Petitioner was receiving more admissions from the local hospital.  On reviewing their records, she found that the new residents had been admitted to the hospital for high fever and shortness of breath and they were given antibiotics.  After a couple days to a week, the individuals were being sent to Petitioner for skilled nursing care and some were still on antibiotics and oxygen.  The new residents' flu and virus tests were negative.  She believed her observations were consistent with a new virus being in the area.  She discussed her observations with LPN Cortez, Dr. Kumar, and another nurse practitioner who was observing similar signs and symptoms.  The decision was made to contact the Health Department for help.  About February 26, 2020, when LPN Cortez contacted the Health Department, the rate of infection and decline of residents was increasing, and residents had to be sent to the hospital.  There was no way to test for COVID-19 at the facility at that time.  However, at that point in time she suspected COVID-19 was the likely diagnosis.  She was informed that two individuals associated with Petitioner had tested positive.  Thereafter, she observed that residents were decompensating quickly.  She assessed residents and those that needed more care than could be provided at Petitioner were sent to the hospital.  Tr. 584-89, 591-95.

PA Carmichael testified, contrary to the assertions of surveyors, that she was not so overwhelmed that she could not do her duties.  She testified that she was in contact with Dr. Kumar for guidance and advice even after he contracted COVID-19 and could not come into the facility.  She also communicated with doctors at the local hospital, Evergreen Hospital, and requested help, which the hospital was unable to provide.  Two epidemiologists for the state arrived but they did not assist with resident care.  She testified that she was assessing residents and sending them to the hospital almost every hour.  She testified that no resident that needed to go to the hospital did not go except those who specifically requested not to go.  She worked until she developed COVID-19

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symptoms on about March 7, 2020.  She testified that between February 28 and March 7, 2020, she was working at Petitioner every day doing resident assessments and she was in contact with Dr. Kumar who was not at Petitioner because he had COVID-19.  Tr. 595-600, 621.  She testified that at one point the emergency room sent residents back to Petitioner who were sick with COVID-19 symptoms because the emergency room refused to take more patients.  Tr. 602-03.

In response to my questions, PA Carmichael testified that residents were being isolated in private rooms as early as January as part of Petitioner's protocol for handling the flu.  Tr. 603-04.  She testified that in February 2020 staff with a cough or runny nose had to wear a mask and those with a fever were sent home.  However, staff were not required to use PPE in the isolation rooms at the time.  Tr. 604-06.  She recalled that her conversation with Dr. Kumar and the other PA was about February 24 or 26, 2020.  Tr. 607.  She testified that she and LPN Cortez discussed contacting the Health Department on February 24, 2020, and LPN Cortez sent an email that day.  On about February 26, 2020, LPN Cortez received a telephone call from the Health Department.  Tr. 608.

On cross-examination, PA Carmichael testified that on about February 4, 2020, she started to notice a pattern of infection.  However, she qualified her response, stating that some of the patients listed on Petitioner's infection line listing (P. Ex. 33 at 4-5) may have been admissions from the hospital who had pneumonia and she could not be certain without examining each resident's records.  Subsequently, she testified that while she became concerned in February, sometime before February 19, 2020, she could not recall exactly when.  She did recall discussing her concern about the occurrence of infections with Dr. Kumar, LPN Cortez, another PA, and the DON.  Tr. 614-17.  She testified that she was not concerned at that time that the increase in infections was COVID-19 because the CDC had not alerted them to the possibility.  Tr. 619-20.  She testified that she recalled that Dr. Kumar did not come to the facility after February 28, 2020, because he had symptoms.  After Dr. Kumar was no longer coming to the facility, he remained available by telephone.  She testified that there was an unusual number of patient transfers and that she and the head nurse managed the transfers.  She testified that Dr. Kumar did not designate another physician to handle his patients.  The two public health doctors who showed up at the facility did not treat residents and mostly asked questions about resident care of those with an unknown infection and about resident transfers.  Tr. 621-22, 624-25.  On redirect examination, she testified that the PPE used for droplet precautions include a gown, mask, and face shield, and that level of PPE was not normally used for pneumonia cases.  Tr. 623-24.  She testified that a doctor or doctors from a local hospital did come to the facility to help but her recollection was that occurred after she became sick on about March 8, 2020.  Tr. 626-27.  She testified that after February 28, 2020, when it was known that there was COVID-19 in Petitioner's facility, the company that did on-site x-rays would no longer come to Petitioner, so Petitioner had to send residents to the emergency room for x-rays.  Tr. 628-29.

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PA Carmichael testified in the state administrative hearing.  She testified that she first spoke to LPN Cortez about a possible outbreak in the facility on February 20, 2020.  She testified that on February 20, 2020, they were really concerned something was going on.  P. Ex. 1 at 58 (state transcript p. 234, lns 3-21).  She also testified that on February 20, 2020, she spoke with Dr. Kumar and at that time she was concerned because she believed that the symptoms she was seeing were not caused by the flu (I infer because flu tests were negative), and she wondered whether the symptoms were related to a cold or a new virus other than COVID-19, because she did not think the residents had COVID-19.  P. Ex. 1 at 65 (state transcript p. 262, lns 18-24).  She testified that on February 27, 2020, she considered the possibility that the symptoms they were seeing in the facility might be COVID-19, but she dismissed that thought because she believed that there was only one case of COVID-19 in the U.S. and that COVID-19 had been contained.  She testified that on February 26, 2020, when she spoke with Dr. Kumar and LPN Cortez and the decision was made to call the Health Department, she had a low suspicion that they were seeing symptoms of COVID-19 in the facility.  She had never cared for a patient with COVID-19 and knew no caregiver who had, so she was not familiar with what it looked like.  She tried to find helpful symptom information on the CDC website but was unsuccessful.  On February 26 and 27, 2020, she did not believe that the sick residents had COVID- 19.  P. Ex. 1 at 62 (state transcript pp. 249-51).

I find that PA Carmichael's testimony is consistent with the evidence of record, unrebutted, and fully credible.

48.  Dhirendra Kumar, MD, is Petitioner's medical director who executed a contract with Petitioner on August 2, 2016, that describes his duties as an independent contractor and not as an employee of Petitioner.  CMS Ex. 9 at 5, 11; Tr. 992-93; PPFF ¶ 34-35.

49.  Pursuant to his contract, Dr. Kumar was required to advise Petitioner's Administrator regarding the adequacy of Petitioner's scope of services, resident care programs, medical equipment, and its professional and support staff.  CMS Ex. 9 at 2.

50.  Dr. Kumar's contract provided that he "may arrange to have certain functions under [his contract] performed by other qualified healthcare professionals" with advance written notice to Petitioner's Administrator.  The contract provided that it was Dr. Kumar's sole responsibility to ensure that any delegated functions were performed by a qualified individual and in accordance with the terms of the contract.  CMS Ex. 9 at 3.

51.  The contract required, among other things, that:

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a.  Dr. Kumar assist in coordinating medical care in the facility, including making rounds to evaluate the adequacy of nursing care, and to help develop, implement, and evaluate resident care policies and procedures to ensure that they reflect current standards of practice, in addition to assisting with implementation and participation in governance of written by-laws, rules, and policies.  CMS Ex. 9 at 3.

b.  Coordinate with Petitioner's Administrator and attending physicians to ensure physician services were available to residents 24 hours per day if their attending physicians were unavailable; and to communicate with attending physicians to ensure residents received appropriate, effective, and prompt medical care.  CMS Ex. 9 at 3.

c.  If there was an organized medical staff at Petitioner (it is not clear what this means and I have no evidence from which to draw an inference), he was to be a member of the staff and "attend meetings" and help ensure adherence to facility by-laws, rules, and policies.  CMS Ex. 9 at 4.

d.  Serve as a member of Petitioner's quality assurance and assessment, pharmacy, and infection control committees.

e.  Unlike the prior requirement to attend meetings of medical staff, there was no specific requirement that he attend meetings of the quality assurance, pharmacy, and infection control committees.  CMS Ex. 9 at 4.

52.  Dr. Kumar's contract provided that time spent as medical director would not exceed 12 hours per month, unless authorized in advance by the Administrator and Regional Vice President.  CMS Ex. 9 at 4.

53.  Dr. Kumar's contract provided that he could serve as an attending physician for residents, but Petitioner had no financial responsibility for services Dr. Kumar delivered in that capacity.  CMS Ex. 9 at 5.

54.  Dr. Kumar's contract does not require that he appoint someone to serve as medical director if he is unavailable or authorize him to do so.  CMS Ex. 9; Tr. 1035.

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55.  Petitioner's Medical Director policy effective June 21, 2019, provides that medical director responsibilities must include their participation in:

a.  Administrative decisions including recommending, developing and approving facility policies related to resident care.

b.  Issues related to the coordination of medical care identified through the facility's quality assessment and assurance committee and other activities related to the coordination of care;

c.  Organizing and coordinating physician services and services provided by other professionals as they relate to resident care;

d.  Coordinating and planning for improvement of medical care in the facility;

e.  The quality assessment and assurance committee or assigning a designee to represent him/her;

f.  Chairing the Medical Director Facility Oversight Committee; and

g.  Designation of an alternate medical director with sufficient training and experience to perform the responsibilities of the medical director when the medical director is unavailable.

CMS Ex. 10 at 2.  This policy requires that the medical director or his/her representative participate in the quality assessment and assurance committee, but it does not require that he attend meetings of any committee other than the Medical Director Facility Oversight Committee (for which the medical director is the chair).  The policy also requires that he participate in the designation of an alternate medical director (if one is selected); it does not require that there be an alternate medical director or that the medical director make the selection of someone to fill that role, and as already noted, such a requirement is inconsistent with the authority granted Dr. Kumar under his contract with Petitioner.

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56.  Petitioner's Medical Director policy effective June 21, 2019, does not require that Petitioner's Administrator or other official designate an alternate medical director to act if the medical director is unavailable.  CMS Ex. 10.

57.  Petitioner's Physician Services Guidelines revised November 19, 2016, requires that physician progress notes be added to a resident's record no more than one week after the physician (or physician extender) visits the resident, and all orders must be signed within 14 days of the date the order is issued, unless the state imposes shorter deadlines.  CMS Ex. 10 at 5.

58.  Petitioner's Physician Services policy revised September 23, 2008, provides that all physician orders must be recorded in the resident's medical record, but does not say how quickly; any telephone orders must be co-signed by the physician within 14 days of the date the order is issued; and progress notes are recorded when the physician or physician extender (e.g., NP or PA) sees the resident or there is a change in resident condition.  CMS Ex. 10 at 11-12.

59.  Petitioner's Physician Services policy revised September 23, 2008, provides that in an emergency, if a resident's attending physician is not available, the alternate physician listed in the resident's records is contacted, and if no alternate physician is available, the medical director is notified.  If no physician coverage is available, the DON or designee determines whether transfer to a hospital is necessary.  CMS Ex. 10 at 10.  The policy requires that each physician who is an attending physician for a resident designate an alternate physician for the resident.  CMS Ex. 10 at 12.

60.  Dr. Kumar remained available, at a minimum remotely by telephone or otherwise, to discharge his duties as medical director, even when he could no longer enter the facility after February 28, 2020, due to his COVID-19 symptoms.  He recalled that after February 28, 2020, he was called by PA Carmichael daily, others at Petitioner, the CDC, and the surveyors, and he did not have resident records available to him during the calls.  Tr. 785, 834-35, 918-21, 941, 1006-07, 1013.

61.  Dr. Kumar was unable to return to Petitioner until late March, possibly March 24, 25, or 26, 2020.  P. Ex. 1 at 71.

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62.  Dr. Kumar ensured that he had coverage for his patients who were Petitioner's residents, either through PA Carmichael or other physicians.  Tr. 580-82, 595-600, 621-22, 836-38, 918-21, 942-48, 1004-06.

63.  Dr. Kumar was the primary care physician for more than 90 percent of Petitioner's residents; he saw some patients of Optum which also had a nurse practitioner (NP).  Dr. True was another primary care physician for other residents, and Dr. True also had a PA or NP that worked with him.  P. Ex. 1 at 70-72.

64.  Dr. Kumar testified credibly that he is a member of Petitioner's Quality Assurance and Process Improvement committee;29 he could not recall how many times the committee met in 2019 and 2020; and he did not attend all meetings but attended as many as he could.  Tr. 994.

65.  Dr. Kumar did communicate with LPN Cortez about infection-related issues outside QAPI meetings.  Tr. 995-96.

66.  Dr. Kumar opined that it is not common practice to complete all notes before sending a resident to the hospital, hospital staff does not wait to treat a resident until they receive all paperwork from a long-term care facility, and hospital staff will do its own assessment and consider whatever paperwork is sent with the resident, such as the resident's face sheet, recent laboratory reports, and any recent progress notes.  P. Ex. 1 at 87-88.

Dhirendra Kumar, MD, testified that he had been Petitioner's medical director for six or seven years.  Tr. 992.  Dr. Kumar also has a private practice of medicine.  Tr. 993.  He is PA Carmichael's employer.  Tr. 993.  Dr. Kumar testified that he is also the primary care physician for most of Petitioner's residents.  PPFF ¶ 37; Tr. 996.  He testified that he was usually in the facility Monday, Tuesday, Thursday, and Friday each week.  He testified that when not in the facility, he was available by cell phone.  Tr. 997-98.  He testified he communicated with PA Carmichael daily.  Tr. 1013.  He testified that if PA Carmichael could not reach him, she was to call Dr. Sahi, but he did not recall that happening.  Tr. 1036-37.

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Dr. Kumar testified that he had no questions or concerns about Petitioner's infection control policies and procedures.  Tr. 999-1000.  Dr. Kumar testified that in January and early February 2020, he was aware of COVID-19 but knew that it was in China with only one case in the Seattle area and the CDC, the local health department, and the media all suggested COVID-19 was contained and it was unlikely that there would be cases in Petitioner's area.  He testified that the patient in the Seattle area was identified with COVID-19 in January 2020, and that patient had traveled to China.  Tr. 1001-02, 1022.

Dr. Kumar testified that it was normal to have a seasonal increase in respiratory diseases, including pneumonia, in the facility every year, and an increase in the number in January or February is not unusual.  Tr. 1002.  He testified that he, PA Carmichael, and LPN Cortez discussed infections and COVID-19 in February 2020.  He became concerned when they did not see improvement in residents and the number of infections started to rise at the end of February 2020.  He decided it was necessary to contact the local health department based on flu tests being negative.  He confirmed that LPN Cortez contacted the Health Department, which provided no clear direction.  Dr. Kumar testified that he was subsequently contacted around midnight (he did not specify a date) that a staff member and resident tested positive for COVID-19.  His direction was to isolate patients with symptoms.  Tr. 1003-05.  He testified on cross-examination that, based on Petitioner's infection line listing for February (CMS Ex. 6 at 3-5), that around February 19 through 22, 2020, he became concerned about the number of pneumonia and lower respiratory infections and shortly thereafter they contacted the local health department.  Tr. 1022-27.  He recalled telling Petitioner's staff at some point that they needed to stop admitting residents, but he could not recall exactly when, possibly February 22 or 23, 2020.  Tr. 1027.

Dr. Kumar testified that he subsequently tested positive for COVID-19 and had to stay home.  Nevertheless, he continued to respond to phone calls from PA Carmichael.  He recalled being contacted by CDC and others at the facility.  The surveyors also called him, and he did not have individual resident records available to him when they called.  He opined based on his research that local health authorities failed to contain the disease.  Tr. 1006-08.  He testified in response to my question that he never designated a backup medical director to act in his absence and he did not think he had authority to do so.  Tr. 1035.

Dr. Kumar testified that as Petitioner's medical director, he is a member of Petitioner's QAPI committee (I infer he meant Petitioner's QAA committee), but he could not recall how many times that committee met in 2019 and 2020.  He testified he tried to attend as many meetings as he could but not all.  Tr. 994.  On cross-examination, Dr. Kumar testified he could not recall attending QAPI (QAA) meetings in January and February 2020.  He also could not recall the dates of any meetings in 2019, or the number of

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meetings.  Tr. 1010-12.  Dr. Kumar testified that he communicated with LPN Cortez outside QAA meetings about infection-related issues.  Tr. 995-96.

Dr. Kumar testified in the state administrative hearing.  He testified that he is the primary care physician for more than 90 percent of Petitioner's approximately 120 residents.  He also saw some residents who were patients of Optum, which also employed a NP.  Dr. True is another primary care physician for residents that are not Dr. Kumar's patients.  Dr. True also has a nurse practitioner or physician assistant that works with him.  Dr. Kumar testified that he and PA Carmichael were at Petitioner to see his patients every day (I infer working day) except Wednesday.  On March 2, 2020, he became ill and was not at the facility for three or four weeks and he recalled returning to Petitioner before the end of March 2020, possibly the 24th, 25th, or 26th.  PA Carmichael saw his patients while he was out and she could call him with any questions.  Subsequently, there were other physicians who came to Petitioner to help, but he could not recall specific dates.  P. Ex. 1 at 70-72, 87 (state transcript at 278-86, 346).  He testified that he believed CMS required that charting be done within 30 days, but their standard practice was to chart within four days.  However, he testified that during a pandemic it was not possible to do documentation.  P. Ex. 1 at 72-73 (state transcript at 286-91).  Dr. Kumar testified that QAA meetings are required at least quarterly and he believed that he attended at least the quarterly meetings.  P. Ex. 1 at 82 (state transcript at 324-25).  Dr. Kumar opined that he would not expect PA Carmichael to finish writing her notes for a resident before that resident is transported to the hospital.  He testified it is not common practice to complete notes before sending a resident to the hospital.  He testified that hospital staff does not wait to treat a resident until they receive all paperwork from a nursing home.  Hospital staff will do its own assessment and look at the information sent with the resident such as the face sheet, recent laboratory reports, and any recent progress notes.  P. Ex. 1 at 87-88 (state transcript at 346-48).

Dr. Kumar's testimony is credible and worthy of weight.

67.  Administrator Basham testified credibly that at the end of February and early March 2020, a large number of staff were ill, and it was difficult to find replacements.  Tr. 831-33.

68.  Administrator Basham testified credibly that she knew of no instance when staff could not obtain direction from physicians when needed.  She also testified that there was no time when Dr. Kumar failed to respond to questions, even though he was sick.  She testified she had no need to find a medical director to cover for Dr. Kumar.  Tr. 834-35.  Furthermore, Petitioner's staff had access to PA Carmichael and other physicians and physician extenders.  Tr. 836-38.

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69.  Administrator Basham did not know whether Dr. Kumar attended QAA meetings in 2019, and there are no documents in evidence to show Petitioner's QAA committee met quarterly or if and when Dr. Kumar attended.  Tr. 828-29, 840.

70.  Administrator Basham testified credibly that in January 2020, she reviewed Petitioner's quality assurance process and found deficiencies, which prompted her to call an ad hoc quality assurance meeting to discuss all Petitioner's quality assurance process and the deficiencies that she identified.  She testified that during her term as administrator Petitioner's quality assurance team met at least quarterly as required by regulation.  Tr. 829-31, P. Ex. 4.

71.  Administrator Basham convened the ad hoc meeting on January 27, 2020, and a follow-up meeting on February 19, 2020, to discuss Petitioner's QAPI program; the stated purpose was to consider improvement of Petitioner's QAPI program because Petitioner did not conduct consistent or effective QAA meetings during the past year; and a plan for regular meetings to identify and address QAPI issues was developed.  CMS Ex. 14 at 2-7, 21.

72.  Administrator Basham determined that Petitioner's QAPI program was deficient, and she was undertaking remedial action as part of the quality improvement process to improve Petitioner's QAPI prior to the survey.

Ellie Basham became Petitioner's Executive Director (Administrator) on January 13, 2020.  Tr. 827; PPFF ¶ 49.  Administrator Basham testified that prior to the survey in issue, Petitioner had the highest rating issued by CMS for a long-term care facility.  Tr. 827-28.

Administrator Basham testified that at the end of February and early March 2020, staff were getting sick and not reporting to work.  She testified that normally Petitioner had 110 to 120 staff and 30 to 35 got sick and did not report to work.  She testified that daily requests were made to nurse staffing agencies and other facilities owned or operated by Petitioner's manager/operator.  She testified that they were unsuccessful in finding replacement staff.  Tr. 831-33.  Administrator Basham testified that the surveyors requested many documents which was difficult due to the number of sick residents and being short on staff.  Tr. 833.  She testified she was not aware of any instance when staff could not obtain direction from physicians when needed.  She testified that there was no time when Dr. Kumar failed to respond to questions, even though he was sick.  She testified she had no need to find a medical director to cover for Dr. Kumar.  Tr. 834-35.

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In response to my questioning, she testified that Dr. Kumar was not the only physician attending to Petitioner's residents.  She testified that Petitioner's staff had access to PA Carmichael and another physician and nurse practitioner.  Tr. 836-38.

She testified that she could not speak to whether Dr. Kumar attended facility quality assurance meetings in 2019, before she arrived.  She testified that she did not tell surveyors that he did not as she would have no way to know.  Tr. 828-29, 840.  She testified that in January 2020, she reviewed Petitioner's quality assurance process and found deficiencies, which prompted her to call an ad hoc quality assurance meeting to discuss all Petitioner's quality assurance process and the deficiencies that she identified.  She testified that during her term as administrator Petitioner's quality assurance team met at least quarterly as required by regulation.  Further, a state agency survey on February 19, 2020, looked specifically at infection control and found no deficiencies.  Tr. 829-31, P. Ex. 4.  She testified that she did find records from quality assurance meetings in 2019 at the request of the surveyors, but there were not many records.  Tr. 840.  Surveyor notes indicated that surveyors received documents from Administrator Basham related to QAPI dated January 21, 2019, March 2019, and September 19, 2019.  CMS Ex. 7 at 18.  The documents do not appear to be in evidence, and I cannot infer that the referenced documents relate to QAPI meetings.  CMS Ex. 14 contains documents obtained from Petitioner during the survey related to the ad hoc QAPI meeting Director Basham convened on January 27, 2020, and a follow-up meeting on February 19, 2020.  The document lists as an opportunity for improvement that Petitioner was not conducting consistent or effective QAPI meetings during the past year under a prior administrator.  The document also outlines a plan for regular meetings to identify and address QAPI issues.  CMS Ex. 14 at 2-7, 21.

I find Administrator Basham's testimony to be credible and worthy of weight.

73.  Petitioner's interim DON effective March 1, 2020, Chelsey Earnest, RN, testified credibly that during the first week of March she called Dr. Kumar 15 or 20 times and he always answered.  Tr. 785.

74.  DON Earnest testified credibly that:

a.  She arrived at Petitioner on about March 1, 2020;

b.  Representatives from the CDC and the State Health Department were present and provided general guidance to treat symptomatic residents as if they had the flu;

c.  On March 7, 2020, the CDC started testing all of Petitioner's residents for COVID-19;

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d.  By March 1, 2020, staff were getting sick or quitting;

e.  As of March 2, 2020, laboratory representatives refused to come to the facility to drop off supplies or pick up samples even if left outside;

f.  Deliveries were dropped off in the street;

g.  EMS refused to enter Petitioner, but she convinced them to pick up residents in the foyer to avoid the media;

h.  Around 3:45 pm on March 1, 2020, residents started to deteriorate rapidly and constant calls to EMS were necessary to transfer residents to the hospital;

i.  Not having a physician present was not a concern because the decision to send a resident to the hospital could be made by the nurses present and PA Carmichael, who was also present;

j.  On about March 4, 2020, two Health Department physicians came to Petitioner and saw residents;

k.  On March 5, 2020, at the request of the local emergency coordinator, PA Carmichael, two State Health Department physicians, a physician from the local ER, and DON Earnest assessed all the residents, approximately 20 residents were assessed as suited for transfer to an acute care setting, and approximately 17 residents were transferred to hospitals as a result;

l.  The survey began on March 6, 2020;

m.  HHS, Public Health Service (PHS) sent medical staff to assist on March 7, 2020.

n.  DON Earnest admitted that during the time many notes were made on note pads and time was not taken to update electronic records due to the emergency.

o.  DON Earnest testified that she checked the record for each resident that the surveyors alleged did not contain all necessary information and she was able to locate that information.

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p.  DON Earnest testified credibly that when residents were transferred to the hospital, their face sheet with all their demographic information, history, diagnoses, recent vital signs, and any other information that could be readily gathered was printed and sent with the residents to the hospital;

q.  It was not possible to wait for nurses to finish all their documentation for a resident before the resident was transferred; and

r.  Nurses also called the emergency room nurse or sent documents to the hospital by facsimile.

Tr. 730, 762-68, 772-83, 786-90 792-94; P. Ex. 1 at 248.

75.  DON Earnest testified credibly that the surveyor observed a computer screen that was in use by a PHS nurse, not Petitioner's staff.  Only staff, including a few maintenance workers and housekeepers were permitted in the facility at the time due to the emergency and there was no risk for access by an unauthorized person.  Furthermore, all staff were trained on privacy requirements for resident records.  Tr. 795-96, 801-05.

76.  DON Earnest testified credibly that all residents were treated as if infected and all were on droplet precautions.  In order to conserve PPE, a line of blue tape was placed on the floor inside resident rooms at least six feet from the bed of the resident nearest the door.  Staff, including laundry personnel, were permitted to enter the room to the line in order to access the hand sanitizer dispenser on the wall in that area as well as drop off clean linen and fresh PPE without the need to change PPE before proceeding to the next resident's room.  Staff who entered a room and passed the blue line entered an area considered contaminated and had to fully don and doff PPE.  Staff were specifically trained on this procedure.  This was an exception to Petitioner's usual policy due to the emergency and PPE shortage.  Tr. 796-801; P. Ex. 1 at 138-140, 209-10.  

77.  DON Earnest testified credibly that the representative of the State Health Department assisted training staff on using sanitizing wipes to clean equipment and referred to the time needed for the wipe chemical to kill and organism as the "dry time."  However, when Capt. Garza quizzed a certified nurse assistant (CNA) on the use of the wipes, he

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asked her what the "kill time" for the wipe was and the CNA was unable to answer as she did not understand what Capt. Garza was referring to.  Tr. 806-07.

Chelsey Earnest, RN, became Petitioner's interim DON on about March 1, 2020.  She testified that when she arrived at the facility on March 1, 2020, Dr. Stone from the CDC and Patty Montgomery, an epidemiologist from the State Health Department, were present and were meeting with a couple of Petitioner's regional vice presidents, the regional director of clinical services, and a DON from another facility of Petitioner's corporate manager/operator.  All were aware of the positive test of one of Petitioner's residents.  She testified that the general guidance they received was to treat symptomatic residents like they had the flu.  She testified that on March 7, 2020, the CDC started testing all Petitioner's residents.  Results of testing were not received for three or four days.  She testified that staff were getting sick and quitting by March 1, 2020, when she arrived.  As of March 2, 2020, laboratory representatives refused to drop off supplies or come to the facility to pick up samples even if left outside.  Deliveries were dropped off in the street.  Emergency service personnel also refused to enter the facility, but she convinced them to pick up residents in the foyer, rather than where they could be seen by the media.  Tr. 730, 762-68.

On March 1, 2020, at around 3:45 p.m., residents began deteriorating rapidly, and it was necessary to constantly call for emergency services for transport to the hospital.  She testified that she was not worried about not having a physician present because residents in respiratory distress needed to be sent to the hospital and she could make that determination within her scope of practice as an RN.  Also, PA Carmichael was present and working and giving advice.  She testified that two physicians from the State Health Department came to the facility, but they were just observing and helping with planning.  She testified that on about March 4, 2020, two physicians from the Health Department came to the facility and saw patients, some of whom they sent to the hospital.  On March 5, 2020, in response to a request by the local emergency coordinator, DON Earnest and PA Carmichael assessed all residents and selected 20 of the most ill residents for transfer to an acute care setting.  The two State Health Department physicians and a physician from the local emergency room reviewed the assessments and, ultimately, 17 residents were transferred to hospitals who agreed to take them, some being 50 miles from Petitioner's facility.  PHS sent medical staff to assist on March 7, 2020.  She testified that during the first week of March she called Dr. Kumar 15 or 20 times and he always answered.  Tr. 772-78, 785.

On March 7, 2020, Petitioner had received tests from CDC and CDC started mass testing of residents.  Tr. 765, 786-87.  The survey started on March 6, 2020.  Tr. 823.

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She admitted that many notes regarding residents were on note pads, but she testified there was no time to update the electronic records.  She testified that she was not aware of any state or federal guideline that required that records be prepared in a certain time.  She testified that she checked resident records for each resident the surveyors alleged had information missing from their record and she was able to find the information.  Tr. 787-90.  She testified that when residents were transferred to the hospital, their face sheets with all their demographics were printed and sent with the residents to the hospital.  She testified it was not possible to wait for nurses to finish all their documentation for a resident before the resident was transferred.  She testified that they also called the emergency room nurse or sent documents to the hospital by facsimile.  Tr. 792-94.

She testified that when she arrived on March 1, 2020, the public was not allowed in the facility.  Regarding the allegation related to the surveyor's observation of a computer screen, she testified that the computer was being used by a PHS nurse, not Petitioner's staff.  She assumed the nurse simply failed to clear the screen before going into a resident room.  She opined no unauthorized person could have accessed protected health information because only people caring for the residents were present in the facility at that time.  Tr. 795-96.

She testified that every resident was presumed to be positive for COVID-19 until proven otherwise and all were on droplet precautions.  Due to a shortage of PPE and hand sanitizer, they placed blue tape on the floor inside each resident room at a safe distance from the residents, i.e. more than six feet.  Laundry staff and caregivers could enter the room up to the tape to obtain hand sanitizer from the room dispenser and to retrieve laundry without needing to change their PPE between different rooms.  The area between the room door and blue tape was also an area where staff could leave PPE between visits to the room, eliminating the need to have fresh PPE for each visit to the residents in the room.  Tr. 796-800.  She admitted in response to my questioning that both the open resident record on the nurse cart computer and entering a resident room and then moving to another resident room without changing PPE when droplet precautions were in effect were contrary to Petitioner's policy; however, the present circumstances were different.  Tr. 800-01.  She also explained that residents could not have seen the record on the nurse cart because the carts were high, and the residents were all confined to their rooms.  The only exception were two residents with dementia whom staff could not get to stay in their rooms.  Both residents were transferred.  She testified when the surveyor made his observation, there were few, if any, staff present such as maintenance workers or housekeepers as such work was being done by caregivers.  She also testified that at least one laundry working was present.  She testified that staff are trained annually on HIPAA (the Health Insurance Portability and Accountability Act) requirements.  Tr. 796-98, 801-05.

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DON Earnest testified credibly that the representative of the State Health Department assisted training staff on using sanitizing wipes to clean equipment and referred to the time needed for the wipe chemical to kill an organism as the "dry time."  However, when Capt. Garza quizzed a CNA on the use of the wipes, he asked her what the "kill time" for the wipe was and the CNA was unable to answer as she did not understand what Capt. Garza was referring to.  Tr. 806-07.

RN Earnest testified in the state administrative hearing.  She testified that the surveyor observed the medication list open on the nurse cart.  She testified that at the time the PHS/HHS nurse was using the cart and she may not have realized that a button could be pushed when she left the cart to obscure the screen.  She also testified that the expectation for staff leaving a resident's room was that disposable gloves and gowns should be removed.  P. Ex. 1 at 137-38 (state transcript pp. 545-47).

She testified that the federal strike team did not arrive until March 7, 2020, at around 6:00 a.m.  The strike team provided one physician, two PAs or NPs, and six or seven RNs for the day and evening shift, and two physicians, one PA or NP, and ten RNs for the night shift.  P. Ex. 1 at 138 (state transcript pp. 548-49).

She testified that when the surveyor saw the open records with patient information, only healthcare staff were in the facility and it was information that they needed to know.  P. Ex 1 at 138-39 (state transcript pp. 550-52).

RN Earnest testified that blue tape was placed on the floor inside each resident's room approximately six feet from the nearest resident bed to create a "clean space" inside the resident's room where staff could put on and take off PPE and have access to the hand sanitizer dispenser placed in each resident's room without the need to put on PPE.  After entering a room, if one passed beyond the blue line, one had to be wearing full PPE as that was treated as the dirty area.  Staff were trained and laundry personnel could enter a room up to the blue line to place laundry in the room closet without needing to don full PPE.  She could not recall CDC guidelines as to when a gown must be changed.  P. Ex. 1 at 139-140, 209-10 (state transcript pp. 552-55, 826-31).

RN Earnest testified that when residents were transferred to the hospital, a packet of documents was sent with the resident which included his or her face sheet which listed the resident's demographic information, diagnoses, recent vital signs, and any other information they could gather to ensure that hospital staff knew how to take care of the resident.  P. Ex. 1 at 248 (state transcript p. 978 lns. 5-12).

I find RN Earnest's testimony to be credible and worthy of weight.

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78.  On February 28, 2020, at about 11:30 p.m., Nancy Butner, Northwest Divisional Vice President, Life Care Centers of America, which is Petitioner's operator or manager:

a.  Was notified by the Health Department that one of Petitioner's hospitalized residents tested positive for COVID-19;

b.  She met with Petitioner's Administrator, a Regional Nurse, and LPN Cortez at Petitioner about 1:00 a.m. on February 29, 2020, to assess the situation and inventory supplies;

c.  She expected the CDC and Health Department to arrive that day but they did not arrive until March 1, 2020;

d.  She was notified on February 29, 2020, that one of Petitioner's nurses who was hospitalized also tested positive for COVID-19;

e.  On February 29, 2020, she was contacting other Life Care Center facilities to try to locate PPE supplies and staff, because many staff were sick and were not allowed to work.  She and staff were also busy assessing residents for signs and symptoms of COVID-19.  They also worked to cohort symptomatic residents.  She testified she was on the telephone with a Health Department representative throughout the day.

f.  During the first five days of March 2020, Petitioner lost 45 to 50 staff out of 175 staff due to illness and Petitioner required 75 staff daily.

g.  On March 2, 2020, Ms. Butner requested, through the County Health Department, federal assistance with staffing and supplies for Petitioner due to the COVID-19 outbreak and shortage of staff and supplies secondary to the outbreak (P. Ex. 41).

Tr. 908-16, 925, 929-31.

79.  The PHS sent healthcare personnel to assist at Petitioner beginning on March 7, 2020.  P. Ex. 42; Tr. 939-41.

80.  Ms. Butner credibly testified that, after Dr. Kumar got sick, she determined it was not reasonable to bring in a replacement medical

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director from another Life Care facility because they were independent contractors to the individual facilities.  She testified that bringing another medical director into Petitioner's facility risked the spread of infection to other Life Care facilities, and physicians who entered would need to quarantine for 14 days after exposure at Petitioner.  She testified that resident care did not suffer due to Dr. Kumar's physical absence from the facility because, PA Carmichael continued to work, Dr. Kumar was available by telephone, and healthcare workers were being sent by PHS and the Health Department.  Tr. 918-21; P. Ex. 1 at 262.

81.  Ms. Butner testified credibly that the role of medical director is administrative and does not involve direct resident care, Dr. Kumar saw some residents as patients in his capacity as a private physician, and PA Carmichael cared for Dr. Kumar's patients.  There were other physicians with patients at Petitioner.  Dr. Kumar also used Dr. Sahi as his backup attending physician.  If Dr. Kumar could not perform as medical director, then the medical director at the corporate office would be contacted.  She testified that there was no daily role for the medical director due to the nature of the position.  Tr. 942-48.

82.  The CDC and County Health Department representatives arrived on March 1, 2020, but they spent only a couple of hours each day at Petitioner.  Tr. 932-36.

83.  As of February 29, 2020, if a resident had signs and symptoms that Petitioner's staff could not manage, the resident was sent to the hospital.  During the night of March 2 to 3, 2020, residents started to decompensate more quickly.  Tr. 932-34, 937-38.

84.  Ms. Butner testified credibly that PA Carmichael was present at Petitioner every day (I infer until March 7, 2020), Dr. Kumar was present one day after March 1, 2020, and there was an arrangement that local physicians would be at the facility each day until PHS assistance arrived.  The PHS doctor and medical staff arrived on March 7, 2020; PA Carmichael was sick and no longer working beginning March 8, 2020; and there was a physician physically present at Petitioner part-time for two weeks. Normally there would be no physician in the facility 24 hours per day because nursing staff consult with physicians by telephone.  Tr. 938-41.

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85.  Ms. Butner testified credibly that Petitioner had an emergency preparedness plan that predated COVID-19 and addressed an emergency related to a widespread infection.  She testified that prior to February 28, 2020, there was no information about COVID-19 that required a change in the plan because they believed COVID-19 was like the flu.  P. Ex. 1 at 256.

Ms. Butner testified that she supports 26 long-term care facilities in Washington, Oregon, and Idaho.  Tr. 908.

On February 28, 2020, at about 11:30 p.m., she was called by the Health Department and advised that one of Petitioner's residents who was in the hospital tested positive for COVID-19.  She was also subsequently informed that one of Petitioner's nurses, who was in the hospital, tested positive for COVID-19.  At about 1:00 a.m. on February 29, 2020, she met with Administrator Basham, Life Care Centers Regional Nurse Marlita Basada, and LPN Cortez at Petitioner to assess the situation and take inventories.  Petitioner's DON was sick and not at the facility.  On February 29, 2020, she was contacting other Life Care Center facilities to try to locate PPE supplies and staff, because many staff were sick and were not allowed to work.  She and staff were also busy assessing residents for signs and symptoms of COVID-19.  They also worked to cohort symptomatic residents.  She testified she was on the telephone with a Health Department representative throughout the day.  She testified that she expected representatives of the CDC and County Health Department to arrive on Saturday, February 29, 2020, but they did not arrive until Sunday, March 1, 2020.  During a meeting on March 1, 2020, with the CDC and County Health Department representatives, there was a general discussion of managing the outbreak, but it was not COVID-19 specific.  She testified that during the first five days in March 2020, Petitioner lost 45 to 50 staff to illness out of a total staff of 175, with a daily staffing requirement of 75.  She requested federal staffing and supply assistance on March 2, 2020 (P. Ex. 41).  Tr. 908-16, 925, 928-32.

Ms. Butner testified that Sunday night to Monday morning (March 2 to 3, 2020), residents started to decline more quickly.  Tr. 932-34, 937.  The CDC and Health Department representative spent only a couple hours each day at Petitioner.  Ms. Butner testified that she expected that the CDC and Health Department would have given them much more direction than they did.  Tr. 935-36.  She clarified that, as of February 29, 2020, if a resident had signs and symptoms that Petitioner's staff could not manage, the resident was sent to the hospital.  Tr. 937-38.  She testified PA Carmichael was at the facility every day (I infer until she became ill).  Dr. Kumar was actually present one day after March 1, 2020.  On Wednesday, March 4, 2020, another physician arrived.  Two physicians from the Health Department arrived sometime during the week of March 1, 2020, to assess the situation.  She recalled that on or about Friday, March 5, 2020, two

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other physicians arrived at Petitioner and looked at some residents.  The arrangement was that local physicians would be at the facility each day until HHS (probably PHS) assistance arrived.  The PHS doctors arrived on March 7, 2020, PA Carmichael was off on March 8, 2020, and did not return to work because she was sick.  There was a physician at the facility part-time every day for two weeks.  She testified that it is normal for there not to be a physician physically present at the facility 24 hours per day.  It is normal for nurses to reach physicians by telephone.  Tr. 938-41.

Ms. Butner testified that there was a discussion about closing Petitioner and moving all residents.  However, the Health Department and CDC representatives both opposed that idea because it would have overloaded local hospitals.  Tr. 921.

She testified that Petitioner had 120 residents on February 28, 2020.  101 residents were ultimately diagnosed with COVID-19, 58 had to be hospitalized, and 39 died (11 at Petitioner and 28 at the hospital).  Petitioner's staff totaled 170 approximately, 67 were diagnosed with COVID-19, and none died.  She testified that they were the first long-term care facility to do mass testing and they did test 100 percent of their residents once, the majority of which she believed were done on March 8, 2020.  A number of residents had a positive COVID-19 test, but they had no symptoms.  Tr. 954-57.

Ms. Butner testified that Dr. Kumar was an independent contractor as Petitioner's medical director, not an employee.  When Dr. Kumar became sick, it was not reasonable to borrow a medical director from another Life Care facility because they were also independent contractors to the individual facilities.  There was also the risk of spreading the disease if another medical director came to the facility and whoever came would not be able to return to his or her usual facility without quarantining for two weeks following exposure at Petitioner.  She testified that she also received word that staff assistance, including physicians, were being sent from HHS (probably PHS) and the Health Department.  Dr. Kumar was always available by telephone.  She opined that resident care did not suffer due to Dr. Kumar's physical absence from Petitioner.  Tr. 918-21.  She testified that Dr. Kumar's medical director role was an administrative position because he did not see residents in that capacity.  He saw residents in his capacity as their primary care physician, and a large number of Petitioner's residents were his patients.  Some of Petitioner's residents had other primary care physicians who had to be contacted for orders for their residents.  She agreed that medical directors do not intervene in the care of residents under the care of a different primary care physician.  Dr. Sahi was Dr. Kumar's backup for his residents but not as a backup medical director.  She explained she felt she knew Dr. Kumar well because he was the medical director during her last three years as administrator at Petitioner.  She also agreed that PA Carmichael never had a role as a medical director for Petitioner, and she saw Dr. Kumar's patients as his PA.  She testified that if Dr. Kumar was not available in his capacity as medical director, the medical director at the corporate level would have been contacted.  She testified that

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because the medical director position is an administrative position which does not involve direct resident care, there are no real medical director emergencies and there is not really a daily role for the medical director.  Tr. 942-48.

She testified that she did track staff time necessary to deal with the surveyors during the first two weeks of March and the total was approximately 400 staff hours.  Tr. 922, 949-54.

Ms. Butner testified in the state hearing that it was necessary to prioritize patient care over completing the documents that the surveyors were concerned about.  She explained that there was an extraordinary number of residents who became critically ill within a short period and even if all staff had been available, it would not have been possible to give priority to completing all documentation at that time.  When emergency medical services arrived to transport a resident, they were orally briefed by nursing staff and essential records describing the resident's history were sent to permit the hospital to care for the resident.  She further explained that in normal circumstances, when a facility sends seven to ten residents to the hospital in a month it is possible to both deliver quality care and complete all documentation.  However, with the COVID-19 outbreak, Petitioner had to transfer approximately 30 residents in a week, which is very different from normal circumstances.  She agreed that with more nursing staff, essentially one nurse for each resident, it would have been possible to complete documents quickly.  P. Ex. 1 at 102-05 (state transcript pp. 406-15).

Ms. Butner testified that Petitioner had an emergency preparedness plan that covered the emergency of widespread infection, and the plan existed prior to the occurrence of COVID-19.  She also testified that prior to February 28, 2020, there was no information about COVID-19 that would have required them to change their existing plan because they believed COVID-19 was like the flu.  P. Ex. 1 at 256 (state transcript pp. 1009-10).

She testified that on Sunday, March 1, 2020, Dr. Molly Stone from the CDC and Patty Montgomery, an infection preventionist with the Health Department, arrived at the facility.  Ms. Butner testified she hoped that they would provide some direction and they did, regarding PPE, and managing residents with COVID-19, including cohorting and isolation.  P. Ex. 1 at 257-58 (state transcript 1015-17).  She testified that the two federal surveyors arrived at Petitioner on Saturday, March 7, 2020.  She opined that their knowledge of COVID-19 was superficial, and they had no idea what facility staff had experienced the preceding week.  They understood the need to wear a mask but otherwise wanted to conduct a normal survey.  She testified that the surveyors took time away from resident care.  P. Ex. 1 at 260 (state transcript 1027-28).  She testified that she did not take action to find coverage for Dr. Kumar's patients when he became ill because they still had coverage for his patients from PA Carmichael, Dr. Kumar was available, and

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they were told that physicians from the Health Department were coming.  P. Ex. 1 at 262 (state transcript at 1034-36).

I find Ms. Butner's testimony to be credible and worthy of weight.

86.  There is no dispute that Petitioner had an infection prevention and control program.  CMS Ex. 8; P. Ex. 30.

87.  Petitioner's infection control program was reviewed during a survey by the state agency in February 2020, and no deficiencies were identified.  Tr. 208-09; P. Ex. 4.

While Petitioner's infection control program was reviewed by the state in mid-February 2020, this fact is not determinative as surveyors can make errors.  However, the fact Petitioner's infection control program was reviewed, and no deficiency was identified is evidence that Petitioner had an infection control program that passed at least one review by the state agency.  The SOD for the survey completed on February 19, 2020, tells us little about the survey except that no deficiencies were found.  P. Ex. 4 at 1.  Documents submitted with that SOD show that a resident tested positive for TB.  The resident was transferred to the University of Washington Hospital, but was ultimately transferred back to Petitioner because she was found not to have TB.  P. Ex. 4 at 2-11.  Surveyor Usea testified that she conducted the survey on February 19, 2020, and she cited no deficiency related to Petitioner's infection control policies and procedures.  Tr. 208-209.  She did not clarify how carefully or to what detail she examined Petitioner's infection control policies and procedures.  I cannot infer based on P. Ex. 4 or Surveyor Usea's testimony that Petitioner's infection control program complied with federal requirements or standards of practice at any time other than during the February 19, 2020 survey, without more information as to the scope of review conducted by Surveyor Usea.  I do accept that there is evidence that Petitioner did, in fact, have infection control policies and procedures that passed Surveyor Usea's examination.

Petitioner's policy is in evidence as CMS Ex. 8.  I note some pages of the policy reflect that they were changed during or following the survey.  I do not consider the fact changes were made to be an admission by Petitioner that its policy was deficient.

88.  The evidence does not show that Petitioner's residents, Residents 118, 122, 125, 129 (CMS Ex. 1 at 7-8), 119, 120, 121, 123, 124, 126, 127, 128, 130, and 131 (CMS Ex. 1 at 10-13), cited under Tag F684, were not assessed, or that Petitioner's staff was not aware of a resident's need, or that any care was delayed or did not meet a standard of practice, or that any resident was not transferred to a hospital when transfer was

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needed, or that any transfer was delayed or unnecessary.  CMS Exs. 15-19, 21, 23-28; P. Exs. 43-56.

Expert Testimony

Dr. Schwartzman and Dr. Katz are offered by the parties as expert witnesses to render opinions, ideally to help with my decision-making.  Their opinions are considered as discussed in the following summary of their testimony.  No specific findings of fact are made based on their testimony because they are expert witnesses, not fact witnesses.  Dr. Hashisaki is offered as both an expert and fact witness.  No specific findings of fact are made based on his testimony as an expert witness.  His knowledge of the facts is based on the fact he was retained by Petitioner after the survey to assist with corrections of deficiencies.  His testimony as to post-survey facts is relevant to determine when Petitioner abated immediate jeopardy and returned to substantial compliance.

William Allen Schwartzman, MD was called by CMS.  Tr. 405.  Dr. Schwartzman's declaration and curriculum vitae are in the record as CMS Ex. 30 (Schwartzman).  He is an attending physician in the Section of Infectious Diseases at the West Los Angeles Veteran's Health Administration Medical Center (VA).  He teaches medical staff at the VA and medical fellows at the University of California Los Angeles, Multi-Campus Infectious Diseases Program.  He is the hospital epidemiologist and chair of the infection prevention and control committee.  He has been a licensed physician since 1971 and worked with infectious diseases for 29 years.  He indicates in his declaration that he is fully familiar with the standard of practice for treating patients with infectious diseases and containing the spread of infectious diseases within a healthcare facility.  CMS Ex. 30 (Schwartzman) at 1-2 ¶¶ 1, 3.  I note that Dr. Schwartzman does not appear to have any specific experience working in long-term care facilities.  CMS Ex. 30 (Schwartzman) at 23-29, Tr. 405, 413.  He was qualified as an expert in infection control, without objection by Petitioner.  Tr. 413.

Dr. Schwartzman testified based on his experience that an outbreak is an increase over the usual baseline frequency of cases of infection.  Tr. 407.  To declare an outbreak of influenza, all that is required is one proven case and one symptomatic case suggestive of flu.  Tr. 407.

Dr. Schwartzman opined in his declaration that Petitioner failed to timely recognize an outbreak of an infection in February 2020; Petitioner failed to follow basic infection control practices; and Petitioner's failures resulted in the spread of a virus that caused serious bodily harm or death to Petitioner's residents.  CMS Ex. 30 (Schwartzman) at 2.  He opined that Petitioner failed to seek timely assistance for several symptomatic residents as required by standard medical practice given the presence, persistence, and severity of their symptoms including pneumonia or lower respiratory infection.  CMS Ex.

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30 (Schwartzman) at 3.  He states based on CMS Ex. 6 that between February 2 and 23, 2020, Petitioner had 14 symptomatic residents.  He opined it is the standard of care in infectious disease to declare an outbreak "when there is a constellation of similar symptoms among one or more [residents] indicative of a contagious disease."  CMS Ex. 30 (Schwartzman) at 3 ¶ 9.  He opined that an outbreak should have been declared by Petitioner on or before February 7, 2020, when five residents were identified with respiratory infections.  Dr. Schwartzman summarizes his opinions as:  (1) Petitioner should have recognized there was an outbreak before February 26, 2020; (2) Petitioner failed to maintain a formal surveillance program using standard disease tracking mechanisms, and failed to devote sufficient resources to infection control; and (3) Petitioner failed to promptly test symptomatic residents.

Dr. Schwartzman's opinions are not accepted as credible and weighty because they are conclusory and not supported by the evidence cited by Dr. Schwartzman or the evidence in the record.  Clearly, Petitioner had three residents between February 1 and 5, 2020, and 14 residents between February 2 and 23, 2020, listed as having either a lower respiratory infection or pneumonia.  However, in each case the resident was diagnosed and prescribed an antibiotic.  CMS Ex. 6 at 3-4.  Dr. Schwartzman suggests either that the diagnoses were incorrect or that they should have been recognized by Petitioner's staff or the residents' primary care physicians as indicative of another unknown infection or pathogen.  Dr. Schwartzman's opinion is unsupported as he did not examine the residents or point to any clinical records for the residents that he reviewed that might support such an opinion.  Dr. Schwartzman's opinion is insufficient to outweigh the diagnoses and treatment of the residents' treating physician or physician's extender.

Dr. Schwartzman opines Petitioner's staff failed to follow standard infection control procedures.  However, he does not state what standard procedures Petitioner's staff failed to implement or follow.  Dr. Schwartzman fails to state what assistance Petitioner failed to request.  I infer that he means that Petitioner failed to report to the Health Department before February 26, 2020.  However, the evidence does not show that either the diagnoses of pneumonia or lower respiratory infections are reportable infections in the State of Washington.  CMS Ex. 29, P. Ex. 22.  Dr. Schwartzman's opinion that Petitioner's action or inaction resulted in the spread of the virus in the facility is conclusory, unsupported by any evidence, and he did not state a scientific or medical basis for his opinion.  He cites no evidence to show Petitioner's staff had a reason to associate the pneumonia and lower respiratory cases identified prior to February 26, 2020, with COVID-19, and to treat them in a manner other than normally required by the diagnosis of the treating physician.  Dr. Schwartzman's opinion that Petitioner failed to timely test symptomatic residents merits no weight as he admitted in testimony that prior to about March 7, 2020, the evidence shows that no test for COVID-19 (more specifically, the virus SARS-CoV-2) was available to Petitioner to screen its residents.  Tr. 472-73.

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On cross-examination, Dr. Schwartzman testified he concluded that Petitioner failed to have a formal infection surveillance program because they failed to report to the resident's primary care physician and Petitioner's management the increased number of respiratory infections they documented.  Tr. 420-24.  This opinion is unsupported as the evidence shows both Dr. Kumar, who was responsible for more than 90 percent of Petitioner's residents, PA Carmichael, a NP or PA for another physician, and LPN Cortez were aware in early to mid-February 2020, of the various diagnosed and treated infections at Petitioner.  Dr. Schwartzman was under the false impression that PA Carmichael worked for Petitioner rather than Dr. Kumar.  Tr. 424.  He testified he was also under the impression that Petitioner did not have an infection control committee to coordinate infection prevention and control as he saw no evidence that they had meetings in February 2020.  Tr. 425-26.  Dr. Schwartzman appears to be unaware that long-term care facilities are not required to have an infection control committee separate from the QAA committee.  54 Fed. Reg. at 5345.  Dr. Schwartzman opined that Petitioner did not have an infection surveillance system that functioned because staff did not recognize an outbreak before February 26, 2020.  Tr. 428.  His opinion is inconsistent with the evidence of record that shows LPN Cortez was tracking infections being treated and that she was communicating with nursing staff about signs of symptoms of possible infection, and that she, PA Carmichael, and Dr. Kumar decided on February 26, 2020, that a number of unexplained fevers constituted an outbreak of an unknown infection and notified the Health Department.  Tr. 615-20, 638-40, 644-47, 650-51, 653-56, 678-80, 702, 1004-08; P. Exs. 38, 39.  He points to the fact that Petitioner's staff did not report the respiratory infections [I infer to the Health Department] prior to February 26, 2020, as evidence of inaction that led to spread of infection among Petitioner's residents.  Tr. 431-32.  He responded to questioning that Petitioner's staff should have contacted the Health Department within a couple of days of February 12, 2020, or at least by February 19, 2020.  Tr. 441, 456.  He agreed that prior to the positive COVID-19 test of one of Petitioner's residents and one staff person, CDC had not announced that there was COVID-19 spreading in the community.  Tr. 444.  He was unaware that Petitioner's staff tested residents with respiratory symptoms for influenza, except, possibly, in one case.  Tr. 446.  He did not know whether it was standard practice in nursing homes in the Seattle-area to conduct more extensive virus testing.  Tr. 446-47.  He attributed the standard for declaring an outbreak to CDC guidelines, but could not identify the specific guidelines. Tr. 447.  He admitted that he did not review State of Washington infectious disease reporting requirements.  Tr. 448.  He testified that he did not see evidence that Petitioner instituted transmission-based precautions before February 26, 2020.  He did not specify which transmission-based precautions, i.e., contact, droplet, or airborne, he thought should have been instituted.  He testified that it would have been appropriate if Petitioner's staff began transmission-based precautions on February 5, 2020.  Tr. 458, CMS Ex. 30 at 6.  He testified that it was not known in February 2020 that COVID-19 could be spread by asymptomatic individuals.  Tr. 458-59.  Dr. Schwartzman agreed that mass testing was not done at Petitioner until early March 2020, and then 70 residents,

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staff, and family members were found to be infected.  He agreed it could be inferred that COVID-19 was spreading for some time prior to testing.  He agreed that COVID-19 was spreading in nursing homes before anyone knew that COVID-19 was present in the nursing homes.  He agreed that the fact there was not universal testing was part of the problem.  Dr. Schwartzman testified, however, that even though Petitioner's staff were not aware they were dealing with COVID-19, they should have started droplet precautions, isolating residents in their rooms, and dividing the sick residents from those who were not sick.  He did not identify the source of a requirement to implement droplet precautions.  Tr. 459-60.  Dr. Schwartzman's testimony shows that he did not know what interventions were implemented by LPN Cortez prior to her report to the Health Department on February 26, 2020.  Tr. 463-64.  In response to my questions, he agreed he would have been more comfortable with the way Petitioner handled the outbreak if LPN Cortez started her interventions around February 19, 2020.  Tr. 470.  He testified that use of software to track laboratory results for purposes of infection control is possible but not required by either CMS or the CDC.  Tr. 471-72.  He testified that had Petitioner recognized an outbreak of an infection as early as February 19, 2020, that recognition would have triggered action to prevent the horizontal spread of whatever the infection was.  Tr. 473-74.  Dr. Schwartzman testified that he would stop the admission of new residents once he identified an outbreak.  Tr. 478.  I note that Dr. Schwartzman did not seem to be aware that CMS never directed that facilities stop admitting residents, even if confirmed to have COVID-19, so long as precautions were implemented.  P. Ex. 19.  I also note that Dr. Schwartzman's opinions appear to be heavily influenced by hindsight.  If Dr. Kumar, LPN Cortez, other physicians, and staff recognized the possibility that they were seeing COVID-19 in early February 2020, and if they implemented in early February the interventions LPN Cortez finally implemented on February 26, 2020, there may have been some impact on the spread of COVID-19 within Petitioner's facility.  While we recognize now that COVID-19 may have been spreading in Petitioner in early to mid-February, there is no substantive legal requirement that Petitioner's infection control team be prescient, particularly given that the Secretary indicated on January 31, 2020, that the risk in the U.S. was low.  CMS Ex. 38.  Further, the CDC and County Health Department were still listing travel to China or exposure to confirmed COVID-19 as part of the diagnostic criteria as late as February 19, 2020.  P. Exs. 5, 25.

I note that February 28, 2020, was the date of the first confirmed cases of one of Petitioner's residents and a staff member testing positive for COVID-19.  The CDC stated in its February 5, 2020 MMWR that the incubation period for SARS-CoV-2 to develop into COVID-19 was 2 to 14 days.  Arguably, therefore, the positive resident and staff member would have been exposed no earlier than on about either February 14 or 15, 2020.  Certainly, it is possible that the infection was in the facility earlier, but I conclude it is not reasonable to expect that Petitioner's infection control team would suspect the infection earlier than they did, particularly given the information being shared by the federal and state government and the CDC during late January and early to mid-February

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2020.  Even though both PA Carmichael and LPN Cortez expressed that they were concerned about the possibility of COVID-19 in early to mid-February 2020, the fact is that the publications of the CDC and the Health Departments at the time indicated that symptoms were like the flu and there was little risk for spreading, particularly if there was no travel to Asia, exposure to one who had traveled, or exposure to one who had COVID 19.

Contrary to what Dr. Schwartzman suggests in his testimony, LPN Cortez actively tracked infections at Petitioner.  CMS Ex. 6 and P. Ex. 33 include LPN Cortez's line listings for purposes of tracking infections and antibiotic use.  P. Ex. 29 is the line listing report LPN Cortez prepared at the direction of the Health Department, which covers both staff and residents.  Tr. 656, 674-76, 684, 694.  The following table compiles the information LPN Cortez collected in her line listings for February 2020.

ONSET DATE	DIAGNOSIS OR SYMPTOMS		EXHIBIT
	RESIDENTS	STAFF
SATURDAY 2/1/2020	1 CASE CELLULITIS		P. EX. 33 AT 4; CMS EX. 6 AT 3
2/2/2020	1 CASE CELLULITIS		P. EX. 33 AT 4; CMS EX. 6 AT 3
	1 CASE URINARY TRACT INFECTION (UTI)
2/3/2020	1 CASE LOWER RESPIRATORY INFECTION		P. EX. 33 AT 4; CMS EX. 6 AT 3
2/4/2020	1 CASE PNEUMONIA		P. EX. 33 AT 4; CMS EX. 6 AT 3
2/5/2020	1 CASE LOWER RESPIRATORY INFECTION		P. EX. 33 AT 4; CMS EX. 6 AT 3
2/6/2020	1 CASE PNEUMONIA, 1 UNKNOWN THAT REQUIRED TB QUANTIFERON TEST		P. EX. 33 AT 4; CMS EX. 6 AT 3
2/7/2020	1 CASE PNEUMONIA		P. EX. 33 AT 4; CMS EX. 6 AT 3
SATURDAY 2/8/2020	1 CASE ELEVATED WHITE BLOOD CELL COUNT
2/9/2020

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ONSET DATE	DIAGNOSIS OR SYMPTOMS		EXHIBIT
	RESIDENTS	STAFF
2/10/2020	1 CASE UTI		P. EX. 33 AT 4; CMS EX. 6 AT 3-4
	1 CASE CONJUNCTIVITIS
2/11/2020
2/12/2020		1 CASE RESPIRATORY SYMPTOMS	P. EX. 29 AT 6
2/13/2020
2/14/2020	1 CASE CELLULITIS		P. EX. 33 AT 4; CMS EX. 6 AT 4
SATURDAY 2/15/2020		1 CASE FEVER	P. EX. 29 AT 4
2/16/2020		1 CASE FEVER/BODY ACHES	P. EX. 29 AT 4, 6
		1 CASE COUGH
2/17/2020		1 CASE COLD	P. EX. 29 AT 4
2/18/2020	1 CASE LOW BLOOD OXYGEN W/COUGH		P. EX. 29 AT 3
2/19/2020	1 CASE LOW BLOOD OXYGEN W/COUGH	1 CASE RESPIRATORY SYMPTOMS	P. EX. 29 AT 3, 5-6; P. EX. 33 AT 5; CMS Ex. 6 AT 4
		1 CASE COUGH/FEVER/MALAISE
	3 CASES PNEUMONIA		P. EX. 33 AT 5; CMS EX. 6 AT 4
2/20/2020		1 CASE COUGH	P. EX. 29 AT 4
	1 CASE LOWER RESPIRATORY INFECTION		P. EX. 33 AT 5; CMS EX. 6 AT 4
2/21/2020		1 CASE RESPIRATORY SYMPTOMS	P. EX. 29 AT 6
	2 CASES PNEUMONIA		P. EX. 33 AT 5; CMS EX. 6 AT 4
SATURDAY	1 CASE LOWER RESPIRATORY INFECTION		P. EX. 33 AT 5; CMS EX. 6 AT 4

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ONSET DATE	DIAGNOSIS OR SYMPTOMS		EXHIBIT
	RESIDENTS	STAFF
2/22/2020
2/23/2020		1 CASE COLD	P. EX. 29 AT 4
	2 CASES PNEUMONIA		P. EX. 33 AT 6; CMS EX. 6 AT 5
2/24/2020	1 CASE COUGH	1 CASE COUGH/BRONCHITIS	P. EX. 29 AT 2, 4-5
		2 CASES COLD/BODY ACHES
		1 CASE FEVER/BODY ACHES
		1 CASE COUGH
2/25/2020	COUGH	2 CASES COLD	P. Ex. 29 AT 2, 4
2/26/2020	9 CASES OF FEVER (2 WITH COUGH, 1 WITH BODY ACHES, 1 WITH MALAISE)	1 CASE COLD/BODY ACHES	P. EX. 29 AT 2-5
	1 CASE SHORTNESS OF BREATH (WITH COUGH AND FEVER)	1 CASE COUGH
	1 CASE LOW BLOOD OXYGEN (WITH COUGH AND MALAISE)	1 CASE COLD
	3 CASES COUGH ALONE
2/27/2020	1 CASE WEAKNESS WITH COUGH AND CONGESTION		P. EX. 29 AT 2
	UTI		P. EX. 33 AT 6; CMS EX. AT 5
2/28/2020	2 CASES COUGH WITH CONGESTION (1 WITH RT EAR PAIN)	1 CASE COLD	P. EX. 29 AT 3-4
		1 CASE COUGH/FEVER
SATURDAY	1 COLD/PHARYNGITIS		P. EX. 33 AT 6; CMS EX. 6 AT 5

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ONSET DATE	DIAGNOSIS OR SYMPTOMS		EXHIBIT
	RESIDENTS	STAFF
2/29/2020

The table reflects that the first week of February 2020 (February 1 through 7, 2020), there were two cases of lower respiratory infections, three cases of pneumonia, two cases of cellulitis, and one UTI, all of which were diagnosed and treated with antibiotics.30   P. Ex. 33 at 4.  No information regarding infections suffered by staff is in evidence.

The second week of February 2020 (February 8 through 14, 2020), among the residents there was a resident with an elevated white blood cell count, one case of UTI, one case of conjunctivitis, and one case of cellulitis, all diagnosed and treated with antibiotics.  P. Ex. 33 at 4.  There were no diagnosed cases of influenza, respiratory infections, or pneumonia among the residents this week.  Among the staff there was one case of respiratory symptoms.  P. Ex. 29 at 6.

The third week of February 2020 (February 15 through 21, 2020), five residents were diagnosed as suffering pneumonia (confirmed in four cases by chest x-ray) and all were being treated with antibiotics.  One resident was diagnosed with a lower respiratory infection, confirmed by chest x-ray, and treated with antibiotics.  P. Ex. 33 at 5.  Two residents were listed as having a cough and low blood oxygen levels, one of whom was transported to the emergency room.  P. Ex. 29 at 3.  Among the staff, there were two cases of respiratory symptoms, three cases of fever, and three cases of cough and/or cold.  P. Ex. 29 at 4-6.  The evidence shows that there was an increase in respiratory symptoms and actual or possible infections during this week.

The fourth week of February 2020 (February 22 through 29, 2020), there was one resident case of lower respiratory infection and two cases of pneumonia, all confirmed by x-ray, and treated with antibiotics.  One resident had a UTI and another is listed as having a cold or pharyngitis on February 29, 2020; both were treated with antibiotics.  P. Ex. 33 at 5-6.  However, Petitioner also had nine residents with a fever, some with body aches, malaise, shortness of breath, or cough, all identified on February 26, 2020.  P. Ex. 29 at 2-5.  Petitioner also had a resident with low blood oxygen, a cough, and malaise, and three residents listed as just having a cough on February 26, 2020.  A resident had a cough on February 24, 2020, another resident had a cough on February 25, 2020, another

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was listed as having weakness, cough, and congestion on February 27, 2020, and two additional residents had coughs with congestion on February 28, 2020.  P. Ex. 29 at 2-4.  Among the staff, there were nine colds, four coughs including one with fever and another listed as bronchitis, and one case of fever with body aches.  P. Ex. 29 at 4-5.  The evidence shows a significant increase in respiratory symptoms and possible infections over the preceding week.

The evidence shows that Petitioner had an increased number of pneumonia and respiratory-related illnesses among staff and residents during the third week of February.  However, the resident cases were diagnosed and being treated.  It was, however, during the fourth week of February 2020, when there was a significant rise in the number of residents with unexplained fevers.  Because the infections during the third week of February were diagnosed and being treated, it was a reasonable medical judgment for LPN Cortez not to contact the health department that week.  Dr. Schwartzman's and the surveyors' contrary opinions are not weighty as they are affected by hindsight that they were unable to set aside when examining and weighing the evidence.

Furthermore, pneumonia and lower respiratory infections are not conditions for which the County Health Department had to be notified.  CMS Ex. 29 at 1; P. Ex. 22 at 1.  Surveyor and expert opinions to the contrary are not credible or weighty as they are inconsistent with the evidence that lists what cases must be reported to the Health Department.

LPN Cortez consulted with Dr. Kumar and PA Carmichael.  On February 26, 2020, LPN Cortez identified a possible outbreak and she did contact the County Health Department to report and receive guidance.  SARS must be reported to the Health Department immediately if suspected or confirmed.  An "emerging condition with outbreak potential" must be reported to the county health department immediately.  An "unexplained critical illness" is required to be reported to the county health department within 24 hours, but this requirement only applies to people under 50 years old.  CMS Ex. 29 at 1, 6; P. Ex. 22 at 1, 3.  The required method for reporting is by a telephone call to the County Health Department.  P. Ex. 22 at 1.  PA Carmichael testified that while she became concerned in February, sometime before February 19, 2020, she could not recall exactly when.  She did recall discussing her concern about the occurrence of infections with Dr. Kumar, LPN Cortez, another PA, and the DON.  Tr. 614-17.  She testified that she was not concerned at that time that the increase in infections was COVID-19 (SARS-CoV-2) because the CDC had not alerted them to the possibility.  Tr. 619-20.  She recalled discussing the situation with Dr. Kumar and another PA on February 24 or 26, 2020.  Tr. 607.  She further testified that she and LPN Cortez discussed on February 24, 2020, and that LPN Cortez did send an email inquiry to the Health Department that day.  Tr. 608.  Dr. Kumar testified, based on Petitioner's infection line listing for February (CMS Ex. 6 at 3-5), that around February 19 through 22, 2020, he became concerned about the number of pneumonia and lower respiratory infections and shortly thereafter, they contacted the

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local health department.  Tr. 1022-27.  He recalled telling Petitioner's staff at some point that they needed to stop admitting residents, but he could not recall exactly when, possibly February 22 or 23, 2020.  Tr. 1027.  LPN Cortez testified that she did not contact the Health Department before February 26, 2020, because she was waiting to see if prescribed antibiotics would be effective.  She also testified that pneumonia and lower respiratory infections were not required to be reported to the Health Department.  She testified that she called the County Health Department on February 26, 2020, and did not file her on-line report with the State Health Department until February 28, 2020, because she was waiting for a call back and instruction from the County Health Department.  She testified that it was facility practice to call the County Health Department every time there was a suspicion of or a confirmed outbreak.  She testified that she called the County Health Department on February 26, 2020, because two nurses reported a number of acute fevers, even though those residents had not been diagnosed and did not appear on her line listing (P. Ex. 33 at 5-6) on February 26, 2020.  Tr. 667-74, 680-87.

Contrary to the opinions expressed by Dr. Schwartzman, the evidence shows that Petitioner had a system or process for tracking infections.  LPN Cortez was following the process.  She was consulting with Dr. Kumar, Petitioner's medical director and primary care physician for approximately 90 percent of Petitioner's residents, and his PA, PA Carmichael.  LPN Cortez's rationale for not calling the Health Department before February 26, 2020, that she was waiting to see if prescribed antibiotics might favorably address the infections on her line listing, is a reasonable medical judgment for the reasons discussed above.  When LPN Cortez learned of a significant increase of possible signs and symptoms of infection on February 26, 2020, she did call the Health Department to report and receive directions.

Morgan Katz, MD, was called as a witness by Petitioner.  Dr. Katz is an assistant professor of infectious disease at Johns Hopkins University.  Her work at Johns Hopkins involves research in long-term care infection prevention and antibiotic stewardship and she works in the Johns Hopkins Hospital.  She became involved in the response to COVID-19 in long-term care early in the pandemic.  At the end of March 2020, she was named the long-term care incident commander for the Johns Hopkins Health System with the primary goal of supporting nursing homes during the pandemic.  Her work including testing in nursing homes, providing infection prevention assessments and guidance, and working to establish the Maryland strike team using the National Guard to help stabilize nursing homes.  She was involved in research based in initial testing in March 2020, that 55 percent of the residents tested positive for the virus but were asymptomatic, which was important because generally only symptomatic residents were being tested in March 2020.  She testified that the research showed it was necessary to test all residents and to do so repeatedly.  She was also involved in research about how quickly COVID-19 spreads in long-term care facility and among dialysis patients.  She was involved in developing training programs for long-term care staffs related to the spread of COVID-

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19.  She testified that studies show that if the COVID-19 virus gets into a facility and is not rapidly identified through universal testing, it can spread to 80 percent of residents within days.  She testified that in her experience asymptomatic spread is more challenging than symptomatic spread.  She explained, based on studies, that people are the most infectious two days before the onset of symptoms.  She explained that it is very difficult to determine whether a nursing home resident is infected with COVID-19 without universal testing.  She testified that she was also a member of the White House COVID Taskforce from May or June to September 2020.  She testified that she is familiar with regulations controlling nursing homes, including infection control regulations, and the 2007 CDC Isolation Guidelines.  Dr. Katz was accepted as qualified to render expert opinions related to infectious disease, epidemiology, and long-term care medicine.  Tr. 517-27; P. Ex. 69.  Based on her education, training, experience, and the fact that her review of the evidence has been very through, I conclude Dr. Katz's expert opinions are entitled to the greatest weight.

Based on Dr. Katz review of Petitioner's line listings for January and February 2020 (P. Ex. 33), she opined that there was no clear cluster of infections or red flag in January and early February 2020.  She testified that it is very common to see respiratory infections in nursing homes in the winter months.  She testified that with even a single respiratory infection, you test for flu and isolate the resident.  She testified that, looking back, COVID-19 was probably developing during the period but there was no way to know that at the time.  She testified that pneumonia is also a very common infection in nursing homes.  She testified that there were no clear clusters of pneumonia at the time at Petitioner.  In January and early-February 2020, the CDC was advising to watch for fever, cough, and likely exposure, which was not likely for a nursing home resident due to the isolated nature of living in a nursing home.  She testified that CDC did not recommend staff screening and visitor restrictions until mid-March, after the events at Petitioner.  She testified that staff screening and visitor restriction turned out to be ineffective due to asymptomatic and pre-symptomatic transmission.  Tr. 529-32.  Dr. Katz testified that it is recommended that when staff suspect a possible infection outbreak, they should start creating a line list to track developing infections to identify if clusters are developing.  If there is a possibility of flu, testing symptomatic residents is recommended.  She testified if there are six cases in the same unit at one time it is necessary to contact the Health Department.  However, in Petitioner's case there were vague and different cases, with no clear string of cases that could have been aspiration pneumonia, a cold, or a UTI.  She testified that there was nothing that connected the cases that should have raised a red flag.  She rejected the assertions that there was a red flag on February 12 or 19, 2020, because the symptoms were different, the cases were sporadic, and the cases were on different units.  She testified that only with hindsight based on current knowledge of COVID-19 is it possible to opine that COVID-19 may have been in Petitioner's facility in early or mid-February 2020.  Dr. Katz opined that even on February 24, 2020, when LPN Cortez requested information about COVID-19

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from the Health Department, there was nothing she could do without the availability of testing.  She testified that it was not possible to tell how long COVID-19 had been in Petitioner's facility.  The other respiratory diseases Petitioner could have checked for in mid-February were the flu and she believed that was done with negative results.  Residents could also have been checked for legionella and strep pneumonia, but most nursing homes do not have the ability to do that and must send residents to the hospital for those tests.  Dr. Katz testified that she accepts the 2007 CDC guidelines on isolation and precautions as authoritative.  The CDC guidelines are symptom-based, i.e., the guidelines are used when a physician identifies someone with symptoms of an infection.  She testified that under CDC guidelines Petitioner's staff did what they were supposed to by isolating symptomatic residents and placing them on transmission-based precautions.  Based on what has been learned about COVID-19, CDC, CMS, and health departments have updated and revised guidelines constantly, some of which she found to be inconsistent.  She testified that CDC did not publish guidelines on asymptomatic transmission until well after the events at Petitioner.  She testified that the events at Petitioner and other nursing homes show how quickly the COVID-19 virus can spread in nursing homes, that there are a variety of symptoms with potential vague presentation in nursing home residents, and that residents can decompensate very rapidly from being asymptomatic and then an hour later decompensate and die.  She opined it is unusual in the case of respiratory diseases in a nursing home for residents to decompensate so rapidly.  She opined that this is an unprecedented crisis that could not be resolved using PPE and that testing to identify asymptomatic and symptomatic residents was necessary but not available.  Tr. 533-42.

She testified that she was aware of COVID-19 in early February 2020 but based on publicly available information she would not expect a nursing staff to have any understanding or the potential risk or vague presentation of symptoms of residents who had no clear exposure.  Tr. 556.  She opined that if resources [I infer including testing] were available for Petitioner to respond to the outbreak with speed there may have been a different result, but resources were not available.  Tr. 558.  She testified that it was her understanding that Petitioner began isolating residents with respiratory symptoms in early February 2020.  Tr. 560.  She testified that nursing homes generally do not have the ventilation systems, i.e., AIIR, necessary to implement CDC airborne transmission precautions.  Tr. 576.

I find that Dr. Katz's opinions and testimony are credible and entitled to greater weight than the opinions expressed by Dr. Schwartzman and the surveyors to the extent that they are inconsistent.  Dr. Katz's opinions are consistent with and supportive of the actions that LPN Cortez and Dr. Kumar took in February 2020.

Peter Hashisaki, MD, was called by Petitioner.  Dr. Hashisaki practices in Bellevue and Kirkland, Washington.  He has been the chairman of the infection control committee at

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Overlake Hospital since 1989, and the head of infectious diseases there since 1991.  He has been doing epidemiology at Overlake Hospital since 1989.  Petitioner offered Dr. Hashisaki as both an expert in infectious diseases and a fact witness.  CMS did not object to Dr. Hashisaki offering expert opinions about infectious diseases.  Tr. 850-52; P. Ex. 68.

Dr. Hashisaki testified that all infectious disease physicians in the U.S. heard about COVID-19 in December 2019.  In January 2020, the question was whether or not the disease would occur in the U.S.  In late January 2020, an individual who had traveled from Wuhan, China was diagnosed with COVID-19 in a hospital in Everette, Washington.  A high school student was diagnosed in Shoreline, Washington in early February 2020, when a physician at the University of Washington tested some nasal flu swabs for COVID-19 (P. Ex. 10).  At that time, physicians were aware the infection was in the community, but the CDC only allowed testing for COVID-19 if there was a known exposure to COVID-19 or travel to Wuhan, China.  The State Health Department denied requests for testing based on the CDC restrictions.  He testified that on February 26, 2020, the CDC announced that testing was permitted for someone with possible signs and symptoms of COVID-19 or pneumonia and no other diagnoses, but only if CDC permitted on a case-by-case basis.  He testified that all patients at Overlake Hospital were screened.  On February 28, 2020, the Health Department agreed to test a patient with pneumonia-like symptoms.  The person tested positive for COVID-19.  She was an LPN who worked at Petitioner.  Two patients also tested positive at Evergreen General Hospital in Kirkland, Washington, one of whom was a resident from Petitioner.  Dr. Hashisaki testified that he recognized then that the epidemic had begun in the United States.  He consulted with Dr. Frank Riedo at Evergreen General Hospital over the weekend [February 29 and March 1, 2020] and Dr. Riedo reported that he had at least a dozen people who had pneumonia without a specific diagnosis.  About that time Petitioner was sending residents to Evergreen General Hospital every day.  Tr. 852-55, 876-77.  He opined that it was a problem that CDC had such tight restrictions on testing, and also limited testing to those who had symptoms when most people with COVID-19 exhibited no symptoms.  He also opined that COVID-19 was getting into nursing homes mostly by healthcare workers, 70 percent of whom had no symptoms.  He testified that COVID-19 is so deadly in nursing homes because residents have comorbidities.  He testified that isolating residents with symptoms would not have been very effective because there were infected residents who were asymptomatic, something which no one understood at the time.  He testified that the same was true with staff.  While employees with symptoms stayed home, about 70 percent who were infected had no symptoms and went to work, continuing the spread of COVID-19.  He testified that most viral infections can be spread by an asymptomatic person for around 24 to 48 hours.  However, with COVID-19, an asymptomatic infected person can be contagious for eight to ten days, which is new and unique, and was not known before about May 2020.  He opined that there was no way for Petitioner's staff to know they were dealing with COVID-19 before

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February 26, 2020, because the CDC would not permit testing.  He opined that there was little Petitioner's staff could have done to prevent the spread given that approximately 50 percent of residents and 70 percent of staff who may have been infected had no symptoms of infection.  As a result, cohorting and isolating residents with symptoms would have had a minimal impact on the spread of the infection.  Tr. 855-58, 868-72, 884; P. Ex. 15 (CDC Morbidity and Mortality Weekly Report, Mar. 27, 2020, reporting CDC findings on asymptomatic transmission in nursing homes); P. Ex. 16 (Arons, et al.,"Presymptomatic SARS-CoV-2 Infections and Transmission in a Skilled Nursing Facility,"  New Eng. J. Med., Apr. 24, 2020 (discussing asymptomatic transmission in nursing homes).

Dr. Hashisaki testified that following the survey, the state agency required that Petitioner retain an expert to review Petitioner's infection control policies and practices and he was retained to conduct the review.  He testified that he reviewed Petitioner's infection control manual and how they handled their first month of COVID-19 cases.  He concluded that Petitioner's staff did as well as could be expected under the circumstances at the time.  He found that Petitioner's infection control manual was fine and, based on working with other nursing homes in King County, Washington on infection control, he was familiar with federal regulatory requirements.  He opined that Petitioner was in compliance with federal requirements.  He interviewed LPN Cortez and concluded everything she had done was fine.  He testified that during February in any year influenza and upper respiratory tract infections are common and to have 10 or 15 people with symptoms of a cough, cold, runny nose, and fever is common in nursing homes and hospitals.  When LPN Cortez called the Health Department, they recommended that in addition to what LPN Cortez had already implemented only that Petitioner use disposable dishes and utensils for serving meals.  He testified that this indicated that the Health Department was at a loss for what more to do also.  He testified that in the healthcare community they were seeing a lot of viral illness without a specific diagnosis and that there was a concern about COVID-19, but they could not make a diagnosis as there were no specific guidelines.  He testified that in mid-February the state agency investigated Petitioner's infection control policy and procedures due to the concern that a resident may have had TB.  However, no deficiencies were identified.  Tr. 858-61.  He testified that a physician does not have to be at bedside to determine a resident needs to be sent to the hospital.  If the resident requires a higher level of care than the nursing home can provide, any nurse can make that judgment.  He also opined, based on his hospital practice, that the receiving hospital only needs a copy of the resident's vital signs, medical problems, and medications in order to render care.  Tr. 861-62.

I find Dr. Hashisaki's opinions and testimony are credible and entitled to greater weight than those of Dr. Schwartzman or the surveyors to the extent that they are inconsistent.  Dr. Hashisaki's opinion that Petitioner's infection control policy and procedures met

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federal requirements is considered weighty.  His opinion that Dr. Kumar and LPN Cortez did fine in addressing the outbreak at Petitioner is also entitled to significant weight.

Surveyor Testimony

"Surveyors are professionals who use their judgment, in concert with Federal forms and procedures, to determine compliance.  42 C.F.R. § 488.26(c)(3).  Surveyors are to use resident outcomes to determine whether a facility is in compliance with federal requirements.  Surveyors directly observe the provision of care and the effects of that care to assess whether it meets the needs of residents.  42 C.F.R. § 488.26(c)(2).  Generally, surveyors are trained investigators.  Surveyors are not presumed to be experts in any particular field though they may be qualified as having expertise in a particular field.  Surveyors set forth their allegations in the SOD.  Their testimony is often helpful to understanding the allegations of the SOD.  For that reason, pertinent testimony of the surveyors that may be helpful is set forth here.

Captain (Capt.) Alex Garza was called as a witness by CMS.  Capt. Garza, a PHS officer since 2001, is assigned as a nurse consultant to CMS in San Francisco.  He received his Master of Science in Nursing in 2000.  He has been a surveyor since 2007 and has participated in more than 200 surveys.  He participated in the survey of Petitioner completed on March 16, 2020.  He and Surveyor Francoise St. Aubin, another federal surveyor, conducted the onsite survey and two state surveyors were offsite assisting.  Tr. 56-58.  He testified that the surveyors determined that during the period Dr. Kumar was out of the facility sick with COVID-19, March 3 through 5, 2020, PA Carmichael was providing coverage for Petitioner's residents who were Dr. Kumar's patients.  He testified that during the period March 3 through 5, 2020, many residents, possibly 40, had to be assessed, medical decisions had to be made, and they had to be transferred to the hospital.  Tr. 87-90.  He testified that during that period Dr. Kumar was not "physically" present at the facility to assist.  Tr. 91.  He testified that PA Carmichael told the surveyors that she consulted with Dr. Kumar by telephone on a case-by-case basis and sometimes sent residents to the hospital without consulting with him.  Tr. 92.  He admitted that he was not aware of any reason a physician assistant in Washington cannot order that a resident be sent to the hospital.  He agreed that the fact that PA Carmichael ordered that residents be sent to the hospital on her own initiative was no violation of a federal or state regulation.  Tr. 92-94.

Capt. Garza testified that his concern was that during the period March 3 through 6, 2020, PA Carmichael could have used assistance because she seemed overwhelmed and many things were not being documented.  He testified that there was no documentation of the changes in conditions that residents who were being sent to the hospital were experiencing.  He stated that the concern is with continuity of care so that the receiving hospital knew what occurred in the facility and that there is a regulatory and policy

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requirement that records be completed.  Tr. 96-97.  He agreed that the regulation, 42 C.F.R. § 483.70(i), does not state how quickly medical records should be completed, and for that reason they look at the facility policy related to documentation.  His recollection of Petitioner's policy is that it required that documentation be completed within one week.  Tr. 97-99.  Capt. Garza's concerns are not based on evaluation of resident outcomes as required by 42 C.F.R. § 488.26(c)(2).  The preponderance of the evidence shows that PA Carmichael cared for her residents, despite being subject to a heavy workload in a stressful situation.  The evidence also shows that there were other medical personnel, including other attending physicians, physician extenders, and Petitioner's nursing staff; as early as March 4, 2020, other physicians were present in the facility assessing residents; and, beginning about March 7, 2020, PHS and other staff arrived at Petitioner and began assisting with the workload.  Capt. Garza's expressed concerns do not establish noncompliance with any federal substantive legal requirement.

He testified that on March 8, 2020, he walked the entire facility and observed forms on medication carts, that may have included resident information.  Capt. Garza did not testify about what information he saw.  However, the SOD records that multiple documents with resident identifiable information were observed on medication carts on March 8, 2020.  Capt. Garza alleges that the information was viewable by the public, but he does not allege in the SOD and he did not testify that anyone was actually viewing or in a position to view the information.  CMS Ex. 1 at 22-33.  He also testified that he found a computer unlocked and it is recorded in the SOD that an agency nurse admitted to him that she left the computer unlocked.  CMS Ex. 1 at 3.  He concluded that people without a need to see the information could have seen it, including housekeepers, food services personnel, and maintenance personnel.  He testified that he considered "public," the word used in the regulation, to include anyone who was not a direct care provider and, for that reason, did not have a need to know the information that may have been accessible.  He testified that he interacted with non-direct care providers during the survey, such as housekeepers, one or two building maintenance staff, and kitchen staff.  Tr. 108-10, 144.  Capt. Garza did not testify that he attempted to determine who left the documents with resident information unsecure on medication carts.  Although he testified that he did interact with staff who were not healthcare workers, he did not testify that he actually saw that they were in the area or had access to the information when he made his observations.

Capt. Garza testified that he cited Petitioner under Tag F713 because during the period March 3 through 5, 2020, Dr. Kumar was not at the facility; a high number of residents were being moved to the hospital; and PA Carmichael was overwhelmed, had to work on her day off, and could barely keep up.  He testified that Evergreen Hospital did send some physician help, but he cited Petitioner because a physician was not available for the "emergent period" of March 3 through 5, 2020.  Tr. 113-14. He agreed that there was nothing wrong with Evergreen Hospital sending a physician to triage patients at

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Petitioner rather than waiting to do so after they were transferred, but he cited Petitioner because Dr. Kumar was not available to assist.  Tr. 115.  Capt. Garza completely discounted the fact that Dr. Kumar remained available, albeit remotely, to supervise the care of his residents.  He admitted that he did not know what agreement or relationship Petitioner had with Evergreen Hospital to accept Petitioner's residents in an emergency and he did not know with whom Petitioner coordinated at the hospital.  Tr. 116-17.  Capt. Garza admitted at hearing that he did not determine whether Dr. Kumar had coordinated with Evergreen Hospital to have a physician sent to Petitioner.  Tr. 117.  On cross-examination he testified that PA Carmichael told surveyors that there was no delay in care or services to residents while Dr. Kumar was out sick, and he testified that he found no instance where a resident was sent to the hospital when they should have stayed at Petitioner.  He testified that the decision to send out a resident to the hospital can be made by a physician, a PA, a NP, or a licensed nurse, and a physician does not have to be at bedside.  He agreed he found no evidence that PA Carmichael acted outside her scope of practice.  Tr. 125-28.  He testified that PA Carmichael told surveyors that staff at Evergreen Hospital complained that Petitioner's residents could not be sent without more information as to what was going on with them.  Tr. 114.  There is no evidence that surveyors contacted Evergreen Hospital staff to determine whether inadequate information to ensure continuity of care was provided for each resident transferred to Evergreen.  He testified that the surveyors were concerned due to a lack of documents showing a consistent flow of what was occurring for the residents, i.e., the continuity of care.  Tr. 128.  He testified more specifically that the surveyors were looking for documentation of changes in condition and what interventions were implemented prior to residents being sent to the hospital.  Tr. 130.  He testified that narratives in the records would have given surveyors an indication of the appropriateness of the decision-making and events from the time of onset of symptoms to the transfer to the hospital.  He testified that this missing information was related to the citation of deficiency under Tag F713.  Tr. 131-32.  He agreed that when the surveyors arrived at the facility that there were a number of outside physicians and nurses at Petitioner providing direct resident care.  Tr. 144.  Capt. Garza's testimony reflects that he was not considering resident outcomes reflected by evidence available to him.

Delores Usea, RN, a nursing home complaint investigator with the state agency, was called as a witness by CMS.  Tr. 170-71.  She testified that she has done over 400 complaint investigations/surveys.  She was part of the team that conducted the complaint investigation of Petitioner that ended on March 16, 2020.  I note that Surveyor Usea was not present at the facility during the survey at issue and, therefore, she made no direct observations which significantly affects the weight of her testimony.  She wrote the allegation of noncompliance under Tag F684 related to quality of care with Surveyor Reimar, who also was not present at the facility during the survey.  Tr. 172-74, CMS Ex. 1 at 2-14.  She testified that the survey (compliant investigation) was conducted from March 6 through 16, 2020, and focused on the period January 2020 through February

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2020.  Tr. 174.  She testified, based on her surveyor notes (CMS Ex. 22 at 23-33), that the surveyors focused on the onset of possible infections before February 26, 2020.  Tr. 175-76.  She opined that there was an unusual number of infections, i.e., an outbreak, from February 3 through 7, 2020, based on CMS Ex. 6 at 3.  Tr. 178.  She testified that the surveyors were also concerned with the number of cases of pneumonia between February 19 and 22, 2020, based on CMS Ex. 6 at 4.  She testified that she did not think that pneumonia or lower respiratory infections needed to be reported to the Health Department.  Tr. 179.  She opined that Petitioner should have reported to the State Health Department on February 7, 2020, after the third case of pneumonia was identified, referring to CMS Ex. 6 at 3.  Tr. 189-91, 193, 197.  She testified that whether the pneumonia was considered to be a healthcare-acquired infection or a community-acquired infection and the resident's location in the facility did not impact her judgment.  Tr. 192.  She admitted that in deciding that Petitioner had an unusual number of infections, she did not base that opinion on reviewing Petitioner's history of infections during flu season, the preceding months, the same month from 2019, or an actual or average number annually.  Tr. 199-200.  She admitted that had she known that Petitioner had three cases of pneumonia in January 2019 (CMS Ex. 6 at 8), that would have changed her opinion.  Tr. 201.  Surveyor Usea's findings and conclusions are rebutted by the weight of the evidence as detailed in the aforementioned Findings of Fact.

On cross-examination she admitted that she did an infection control survey at Petitioner after February 7, 2020, and cited no deficiencies related to Petitioner's infection control policies, procedures, and practices.  Tr. 208-09.

Francoise St. Aubin, nurse consultant for CMS, was called as a witness by CMS.  She participated on site with Cpt. Garza during the survey of Petitioner that ended on March 16, 2020.  She testified that she worked on Tags F837, F841, F865, and F880.  Tr. 211-13.  She testified that the surveyors determined that Petitioner was not compliant with federal infection control regulations.  She testified that the survey concluded that Petitioner failed to recognize early a respiratory outbreak and failed to determine the practices needed to prevent the spread of the infection.  She alleged Petitioner failed to timely report to the Health Department and the state agency.  Tr. 214.  She opined that Petitioner had a spike in infections in January 2020, with an infection rate of 4.5 percent which would normally have been about 4 percent.  She opined the increase was due to respiratory infections.  She testified that the infection rate continued up in February 2020, to 7 percent, and again the increase was related to respiratory infections, specifically pneumonia and lower respiratory symptoms.  Tr. 221-22.  She opined that "there was a significant amount of respiratory pneumonias and lower respiratory infections that were acquired in the facility."  Tr. 229.  She testified that LPN Cortez told her she had concerns on February 8, 2020, and by February 12, 2020, she was certain something was wrong.  LPN Cortez started training staff on PPE, infection control, hand hygiene, and transmission-based precautions on February 5, 2020.  Tr. 237-38, 254.  She testified that

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Petitioner gave her the records admitted as CMS Ex. 14, which are records related to an ad hoc QAA meeting held on January 27, 2020.  She identified CMS Ex. 10 at 2 as Petitioner's policy establishing the responsibility of the medical director.  She testified that pursuant to Petitioner's policy, the medical director is supposed to participate in the QAPI program, but Dr. Kumar did not attend meetings in January and February 2020, when the QAPI program was discussed.  CMS Ex. 14 at 1, 21.  She testified that QAPI and infection control are connected but infection control was not discussed during the February 19, 2020 meeting (despite the concerns of PA Carmichael and LPN Cortez) according to what she was told during interviews and based on the fact that LPN Cortez and Dr. Kumar did not attend that meeting.  She pointed out that staff was being trained and visitors were also being trained at the front desk, which she opined, indicated something was going on in the building.  Tr. 239-43.  She testified that Dr. Kumar, PA Carmichael, and LPN Cortez were interviewed, and all were aware of the infections in February identified on CMS Ex. 6 at 3-4.  She testified that when she spoke to the Administrator, the Administrator told her she was unaware of the house-acquired infections (also referred to as healthcare-acquired or, more correctly, healthcare-associated infections (https://www.cdc.gov/hai/index.html (last visited Nov. 4, 2021))).  She was unable to interview the DON because he was not available.  LPN Cortez told her that it was flu season and Surveyor St. Aubin took that to be LPN Cortez's explanation for the source of the pneumonias and lower respiratory infections identified in early February 2020.  She testified that she discussed with LPN Cortez the list of reportable illnesses.  She opined that the requirement is to report within 24 hours if you do not know the cause of an infection.  Tr. 243-46.  She testified that because there were a number of healthcare acquired infections (CMS Ex. 6 at 3-4), LPN Cortez should have reported to the Health Department under CDC guidelines because the pneumonias and lower respiratory infections were not responding to treatment and flu tests were negative, according to PA Carmichael, Dr. Kumar, and LPN Cortez.  She testified that the three did not state when they made the determination that the infections were not responding to antibiotics.  She testified LPN Cortez told her she became concerned about February 12, 2020.  She also testified that the training being given to staff was titled "infection control, influenza, and coronavirus" and not specifically SARS-CoV-2.  Tr. 247-50.  She believed that LPN Cortez should have contacted the Health Department on February 12, 2020, and February 19, 2020, was another date she should have called.  Tr. 253.  She testified that LPN Cortez told her that they started screening visitors, monitoring residents, and they started training on PPE, transmission-based precautions, and hand hygiene.  She did not believe transmission-based precautions were implemented as of February 12, 2020.  Tr. 254-56.  She opined that an influenza outbreak had to be reported to the Health Department according to the Health Department list of notifiable conditions (P. Ex. 22 at 1).  Tr. 256-57.  She agreed on cross-examination that the requirement to report to the Health Department an unexplained critical illness or death only applied to persons under 50 years old, and she could recall no residents involved that were under 50.  Tr. 264; P. Ex. 22 at 1, 3.  I note that, contrary to the surveyor's testimony, influenza is to be

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reported if it is a novel or unsubtypable strain and there is no language suggesting that reporting of influenza is required based on mere suspicion.  P. Ex. 22 at 1.  On cross-examination, she admitted that LPN Cortez was interviewed during the survey by telephone because LPN Cortez was home suffering from COVID-19.  She further admitted that she had no knowledge of whether LPN Cortez had any documents from the facility related to infection control, including CMS Ex. 6, available to her when she was interviewed.  She could not recall whether the interview lasted one or two hours.  Both she and Capt. Garza directed questions to LPN Cortez.  Surveyor St. Aubin testified that LPN Cortez seemed coherent and able to promptly respond to questions, and she had consented to the interview.  She testified that she had several conversations with LPN Cortez.  Tr. 267-68.  Surveyor St. Aubin testified that though P. Ex. 33 at 1-3 shows a total of 13 cases of pneumonia, bronchitis, and lower respiratory infections in January 2020, it was not necessary for Petitioner to report to the Health Department because LPN Cortez did not have any suspicions.  She testified that the regulations require that a report be made if there is a suspicion of an outbreak.  She testified that she relied upon LPN Cortez's and PA Carmichael's statements that it was not unusual to have infections during flu season in January 2020, the incidence of flu in January 2020 seemed normal, and LPN Cortez and PA Carmichael did not suspect anything unusual in January 2020.  Tr. 269-72.  She testified that she was aware that LPN Cortez did contact the Health Department on February 26, 2020, but she did not know the response of the Health Department.  Tr. 273-75.  She agreed that respiratory illnesses are more common during the winter in certain parts of the country.  She testified that between October and March each year, facilities do more staff training and education on the flu and work to ensure that staff and residents receive the influenza vaccination.  Her testimony indicates that she understood that LPN Cortez was telling them that it was flu season and that was what she believed she was dealing with, at least initially.  She testified that she looked at line listings for Petitioner back to October 2019, but she did not look at infection data for February 2017, February 2018, or February 2019.  She testified that LPN Cortez told her that she became concerned on February 8, 2020, that something was unusual and that she was certain by February 12, 2020, that something was unusual because tests were coming back negative and the residents were not responding to treatment.  She testified that LPN Cortez told her she was focused on the fact that it was flu season.  Tr. 279-81.

Surveyor St. Aubin did not consider or gave little consideration to the fact that LPN Cortez was responding to questioning by telephone while ill with COVID-19 and without facility records.  I also note that Surveyor St. Aubin's findings and conclusions were based on her perception of interview responses with little consideration of the circumstances.  There was no follow-up with LPN Cortez after she had recovered and could return to the facility to access the actual evidence that needed to be addressed.  In response to my questioning, she testified that the QAPI regulation requires that the medical director attend QAPI meetings.  Tr. 281-82.  She testified that Administrator Basham told her the QAA committee was not meeting.  Tr. 289.  Surveyor St. Aubin did

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not give testimony from which I can infer that she considered that Administrator Basham had determined that Petitioner's QAPI process required improvement and that she was taking steps through the QAPI process to make necessary corrections.  Upon further questioning by CMS, Surveyor St. Aubin testified that she saw evidence that quality assurance meetings occurred but no evidence the medical director attended, and she believes that is required by the regulation.  Tr. 291.  As discussed hereafter, she was mistaken in her understanding of the regulation.  She opined that Dr. Kumar did not fulfill the terms of his medical director contract with Petitioner, specifically paragraph D.1.11 (CMS Ex. 9 at 4). Tr. 292.  I reject her opinion to the extent it is based on the fact she saw no evidence that Dr. Kumar attended the January or February 2020 meetings because the cited clause of the contract establishes no requirement for Dr. Kumar to attend a meeting, only that he serve on the committees listed.  CMS Ex. 9 at 4, ¶ D.1.11.

Patricia Reimar, RN, field manager for the state agency's Residential Care Services and a state agency surveyor, was called by CMS and testified.  She testified that Petitioner is in her service area and she participated in the survey of Petitioner that ended on March 16, 2020, though she was not present at Petitioner during the survey.  She participated in creating the SOD (CMS Ex. 1).  She listened to interviews and did record review.  She worked particularly in drafting the allegations under Tag F684.  Tr. 302-05, 307; P. Ex. 1 at 164.  She testified that CMS Ex. 8 is a copy of Petitioner's infection prevention and control program and plan obtained from Petitioner during the survey.  She opined that Petitioner incorporated in its policy by reference the CDC recommendations and guidelines.  She testified that the surveyors' record review focused on the period from the beginning of March 2020 through the end of the survey on March 16, 2020.  Tr. 305- 07.  She testified that she had reviewed CMS Ex. 6, Petitioner's infection control reports.  She said the survey team noted the number of respiratory symptoms and illnesses and interviewed Petitioner's staff about the report.  She testified it was noted that at least 14 residents had signs and symptoms of respiratory illness, pneumonia, and lower respiratory illness during February 2020.  She testified that LPN Cortez told them that she noticed a cluster of residents with such illness starting in December 2019 (I infer she meant February 2020 (Tr. 113)).  She admitted that she did not actually listen to the interview of LPN Cortez, which was conducted by the federal surveyors, and I give no weight to her findings related to LPN Cortez's interview.  She testified that PA Carmichael told them she thought there was an unusual number of residents with respiratory illness about December 19, 2019, but then clarified the date was February 19, 2020.  She testified that Petitioner continued to admit residents to the facility until February 26, 2020.  She testified that PA Carmichael said during her interview that she did not report to the Health Department on February 19, 2020.  She did not testify that PA Carmichael was asked why she did not report to the Health Department on February 19, 2020, and that seems to be a logical question if reporting was the surveyors' concern.  She testified that when the report was made to the Health Department was a concern because the Health Department staff are the experts on infectious diseases, and they could

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offer assistance in determining the cause of the illnesses and appropriate interventions to prevent transmission.  In response to my questions, she could not articulate what the Health Department could have done quicker if LPN Cortez or PA Carmichael reported to the Health Department on February 7 or 12, 2020, rather than February 26, 2020.  Tr. 308-19.  She testified that based on review of CMS Ex. 12 at 33, that from February 19 through 28, 2020, Petitioner admitted 11 residents from Evergreen Hospital, which was a period after February 19, 2020, the date PA Carmichael allegedly told surveyors she was concerned about the number of respiratory infections.  Tr. 319-21.  She testified in response to my question that the surveyors identified no resident who was sent to the hospital that should not have been.  She testified that the surveyors were unable to determine whether a resident should have been sent to the hospital sooner due to lack of documentation.  She testified that they could also not determine whether assessments were not done due to the lack of documentation.  Tr. 352-53.  She testified on cross-examination that she believed Petitioner had an outbreak due to the large number of residents involved.  Tr. 363.  She testified that she knew that PA Carmichael was home sick with COVID-19 when she was interviewed by the surveyors.  Tr. 368.

B.  Conclusions of Law and Analysis

The noncompliance alleged under Tags F684, F713, and F880 allegedly posed immediate jeopardy to Petitioner's residents.  These allegations of noncompliance, which are the basis for the imposition of a CMP in the higher range of CMPs reserved for immediate jeopardy noncompliance, are discussed first followed by the non-immediate jeopardy Tags, which are not a basis for imposing a CMP in the higher range.

1.  Petitioner did not violate 42 C.F.R. § 483.25 (Tag F684) (s/s L).

CMS alleges that Petitioner violated 42 C.F.R. § 483.25, which is titled "Quality of Care."  The regulation provides:

Quality of care is a fundamental principle that applies to all treatment and care provided to facility residents.  Based on the comprehensive assessment of a resident, the facility must ensure that residents receive treatment and care in accordance with professional standards of practice, the comprehensive person-centered care plan, and the resident's choices, . . . .

The regulation requires that Petitioner ensure its residents receive care and treatment that is based on (1) the resident's comprehensive assessment, (2) the resident's comprehensive person-centered care plan, (3) resident choices, and (4) professional standards of practice.  The substantive legal standard is clear except the regulation does not specify what are accepted professional standards of practice.  Therefore, CMS must

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as part of its prima facie case present evidence to establish accepted professional standards of practice, subject to rebuttal by Petitioner.  Hillman Rehab., DAB No. 1611 at 8.

The surveyors allege in the SOD that Petitioner violated 42 C.F.R. § 483.25 because:

[T]he facility failed to have a system in place that ensured timely action related to an identified respiratory outbreak within the facility.  This failure created an environment in the facility in February and March 2020 which resulted in multiple residents experiencing inadequate provision of care and services.  Multiple residents experienced acute changes in condition such as respiratory distress, changes in vital signs, hospital transfers and in some cases, death during this outbreak.

CMS Ex. 1 at 2.  The surveyors alleged further that:

1.  There was no evidence Petitioner recognized all possible systemic risks and concerns related to the known outbreak;

2.  Petitioner did not anticipate the need to develop contingency plans to address how the outbreak would affect the consistent provision of quality of care and services, including infection control, sufficient medical provider and staff coverage, resident assessment and monitoring, and the delivery of care;

3.  Petitioner failed to timely notify public health authorities;

4.  Petitioner failed to seek assistance from infection control experts;

5.  Petitioner failed to ensure the availability of emergency physician services 24 hour per day; and

6.  Petitioner failed to ensure there was documented evidence of adequate and consistent resident evaluations, monitoring or consistent provision of care.

The surveyors allege that Petitioner's failings caused acutely ill residents to be emergently transferred out of the facility and the deaths of residents, and that amounts to

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immediate jeopardy.31   CMS Ex. 1 at 3.  Each of the allegations are also discussed in more detail under the discussion of the individual deficiency allegations that follow.

The first allegation that Petitioner did not recognize all systemic risks and concerns related to the COVID-19 outbreak imposes an unreasonable standard upon long-term care facilities that is not found in 42 C.F.R. § 483.25.  COVID-19, which was early on referred to as the novel coronavirus, posed risks and concerns not initially recognized by the Secretary, the CDC, state and local health departments, and experts in epidemiology.  Prior to the outbreak at Petitioner, it was not anticipated that COVID-19 would spread widely in the US; asymptomatic and pre-symptomatic spread were known by the CDC to be an issue with SARS-CoV from 2002-2003, but for some unknown reason was not predicted to contribute to the spread of SARS-CoV-2; the risk to the elderly confined in nursing homes, particularly with comorbidities, was known by the CDC, but no test was widely available for those possibly infected, particularly the asymptomatic and pre-symptomatic; there was no vaccine; the rapid decompensation of those infected was not anticipated; and the CDC guidance focused on identification of signs and symptoms and travel to China or contact with someone infected (which, due to the unavailability of testing, had to be based on the identification of symptoms).  Findings of Fact 5-19.  I conclude it is unreasonable to impose upon a long-term care facility the obligation to anticipate all risks and concerns related to an infectious disease outbreak, particularly in a case such as this where the CDC, the Secretary, the state and county health departments stated that the risk was low and that diagnostic criteria should include travel to China or exposure to COVID-19.  Findings of Fact 17-20.  In fact, not until March 13, 2020, did CMS (rather than the CDC) issue guidance to long-term care facilities that more aggressive interventions were necessary to address COVID-19.  The CMS recommended interventions were nearly identical to those that Petitioner specifically addressed and implemented on February 26, 2020, two weeks before the CMS guidance was issued.  Findings of Fact 22, 35-38, 42, 43.

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Regarding the surveyors' second allegation, the evidence shows that Petitioner had an infection control program and contingency plans intended to address infectious disease outbreaks and their impact on facility operations and the quality of care to be delivered to residents.  Findings of Fact 85-87.  The evidence shows that Petitioner required that attending physicians have alternate physicians designated as required by 42 C.F.R. § 483.30(a).  Finding of Fact 59.  The evidence clearly shows that Petitioner had arrangements for transfer of residents who needed a higher level of care to a local hospital, which was consistent with CMS guidance issued March 13, 2020.  Findings of Fact 22, 40, 74, 83.  Although the evidence shows that COVID-19 created significant stress on Petitioner's staff and management, the evidence also shows that Petitioner's management team was able to ensure there was sufficient staffing to provide quality care to residents including assessment, monitoring, and care.  Findings of Fact 40, 46, 68, 74, 78g, 79, 81, 84, 88; Tr. 859-61.

The surveyors cite 14 residents as examples under Tag F684, Residents 118, 122, 125, 129 (CMS Ex. 1 at 7-8), 119, 120, 121, 123, 124, 126, 127, 128, 130, and 131 (CMS Ex. 1 at 10-13).  The surveyors allege in 10 of the examples that the resident was last seen by a "medical provider" on dates from February 13, 2020 through February 28, 2020, before they were sent to the hospital.  CMS Ex. 1 at 7-8, 10-12.  In the case of Resident 129, the surveyors allege that there was no documentation of a medical provider evaluation immediately prior to the resident's transfer to the hospital.  CMS Ex. 1 at 8.  For each of the residents except Resident 126, the surveyors alleged that there was inconsistent care and monitoring of the resident.  CMS Ex. 1 at 7-8, 10-13.  The surveyors do not explain what they mean by "medical provider," whether they are referring to each resident's attending physician or a member of Petitioner's nursing staff.  The surveyors do not allege how often a resident's attending physician or a physician extender (PA or NP) for the attending physician must actually see a resident and document an assessment with a progress note.  However, 42 C.F.R. § 483.30(c)(1) specifies that a resident must be seen by a physician at least once every 30 days for the first 90 days after admission and every 60 days thereafter.  After the first visit by the physician, his or her PA, NP, or clinical nurse specialist can make the required visits.  42 C.F.R. § 483.30(c)(4), (e).  The surveyors identify no statutory or regulatory requirement, policy, or standard of practice that requires that an attending physician or his or her extender must assess the resident prior to transfer to the hospital.  Based on my review of the records in evidence for each of the residents, I conclude that each resident was seen by Petitioner's staff and/or a primary care physician or extender prior to transfer to the hospital.  CMS Exs. 15-19, 21, 23-28; P. Exs. 43-56.  The surveyors also allege that 13 of the 14 residents received inconsistent care and monitoring.  The surveyors do not cite specific examples of inconsistent care and monitoring or what the standard is for care and monitoring but merely allege inconsistent care and monitoring.  Of course, the burden is upon Petitioner to show that each of the residents received quality care in accordance with his or her comprehensive assessment, plan of care, preferences, and standards of practice.

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Considering all the evidence, I have found no evidence that any of Petitioner's residents were not assessed, or that Petitioner's staff was not aware of a resident's need, or that any care was delayed or did not meet a standard of practice, or that any resident was not transferred to a hospital when transfer was needed, or that any transfer was delayed or unnecessary.  CMS Exs. 15-19, 21, 23-28; P. Exs. 43-56.  I conclude that Petitioner's residents did not receive inconsistent care and monitoring to the extent that any resident was denied quality of care consistent with his or her comprehensive assessment, plan of care, personal preferences, and standards of practice.

I conclude based on all the evidence that Petitioner had an emergency preparedness plan in effect prior to the outbreak of COVID-19 that addressed the possibility of an outbreak of a widespread infection (Finding of Fact 85).  I further conclude that Petitioner, though resources were stressed, did provide necessary care and services for each resident.

Regarding the third allegation, I have found that LPN Cortez did contact the County Health Department on February 24, 2020.  She did not inform the County Health Department of an outbreak of infection on February 24, 2020, but she sought information or guidance related to COVID-19.  Finding of Fact 31.  LPN Cortez did contact the County Health Department and report the outbreak on February 26, 2020.  However, it was not until February 27, 2020, that a representative of the County Health Department discussed the situation with LPN Cortez.  Findings of Fact 32-34.  I have found that it was a reasonable medical judgment by LPN Cortez to wait to determine whether antibiotics were addressing known infections.  Finding of Fact 32.  Dr. Katz's testimony informs and supports my conclusion.  Tr. 529-42, 556.  On February 26, 2020, however, when a significant number of residents were identified with a fever, LPN Cortez decided to wait no longer to report an outbreak.  Findings of Fact 32-34.  The surveyors and CMS wish to second guess the decisions of Dr. Kumar, PA Carmichael, and LPN Cortez, advocating that the call to the County Health Department should have been made on February 19, 2020, or earlier.  The CDC guidance, state and county health department guidance, and state and federal declarations available to Dr. Kumar, PA Carmichael, and LPN Cortez on February 19, 2020, and before, indicated that without travel to China or contact with one infected with COVID-19, there was little probability of SARS-CoV-2 infection.  Findings of Fact 5, 17-19.  Given the fact that most of Petitioner's residents were not travelers and that COVID-19 among hospitalized patients had not been diagnosed in local hospitals from which Petitioner received transfers, it is not reasonable to conclude that Dr. Kumar, PA Carmichael, and LPN Cortez had reason to suspect on February 19, 2020, or before, that the infections reflected on LPN Cortez's line listing were anything but the annual round of flu, pneumonia, and other respiratory illness.  It was reasonable medical judgment to wait and see whether any recorded infections actually responded to antibiotics.  None of the infections listed on the line listing (CMS Ex. 6 at 3-5) triggered any state reporting requirements (CMS Ex. 29; P. Ex. 22) or reporting under Petitioner's policy, even as amended during the survey (CMS Ex. 8 at 8).

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I conclude that LPN Cortez's notification of the outbreak on February 26, 2020, was timely.

Regarding the fourth allegation, it is not clear which experts the surveyors thought Petitioner should have sought out.  However, the County Health Department was a source of expertise that LPN Cortez queried on February 24, 2020, and attempted again on February 26, 2020, with a follow-up on February 27, 2020.  Findings of Fact 31-34.  I have concluded that the February 26, 2020 telephone call to the County Health Department was timely notification of the outbreak at Petitioner.  I also conclude that as of February 5, 2020, it was the department of health that CDC recommended be contacted with information about a possible outbreak of COVID-19.  Finding of Fact 18g.

The fifth allegation verges on frivolous.  The evidence is clear that PA Carmichael was assessing and treating the bulk of Petitioner's residents who were Dr. Kumar's patients, roughly 90 percent of Petitioner's residents.  After Dr. Kumar was unable to enter the facility due to contracting COVID-19, the evidence shows that PA Carmichael's delivery of care to Dr. Kumar's patients was under the supervision of Dr. Kumar and he remained available to consult with her even while unable to enter the facility.  Findings of Fact 45, 60-61, 63, 68, 80-81.  The evidence also shows that residents were transported as necessary to the emergency room when they required a higher level of care than Petitioner's staff could deliver.  When the local hospital was overburdened, arrangements were made for residents to receive emergency care at other hospitals.  Findings of Fact 46, 83.  The surveyors seem to have the misconception that a facility must provide physician emergency services 24 hours per day and in the facility.  However, as discussed further under Tag F713, the regulation does not require that Petitioner actually provide emergency physician services 24 hours per day but provides that Petitioner may arrange for such services.  Furthermore, the regulation imposes no requirement that such physician services be provided within the facility.  Petitioner's policy requires that physicians designate a backup, and if the backup is not available, then the medical director or his or her backup or the corporate medical director may be contacted.  Finding of Fact 59.  Nothing prohibits services being provided by telephone or video conference and such delivery of services is specifically recognized by CMS in the SOM, App. PP, Tag F841 (rev. 173, eff. Nov. 28, 2017).  CMS Ex. 33 at 2.  Nothing prohibits services from being provided by an arrangement through the local hospital.  The requirement is that Petitioner must have a plan to ensure that residents can receive the services of a physician in an emergency 24 hours per day.  Where services are to be delivered is not specified.

The sixth allegation is that Petitioner failed to ensure there was documented evidence of adequate and consistent resident evaluation, monitoring, or consistent provision of care.  The real focus of this allegation based on the testimony of the surveyors and the

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allegations in the SOD is that, during the emergency, Petitioner's staff was not documenting every assessment and intervention provided to residents.  Petitioner does not deny that documentation during the emergency that existed during the early days of March 2020 did not meet Petitioner's own standard for timeliness of documentation of resident care and treatment.  Finding of Fact 74n.  However, I conclude that documentation was adequate under the regulatory requirements and the failure to meet Petitioner's more stringent policy should be excused during the period of the emergency.  More importantly, the evidence shows that no resident was denied quality care due to any documentation deficiencies during the outbreak.

2.  Petitioner did not violate 42 C.F.R. § 483.30(d) (Tag F713) (s/s L).

CMS alleges that Petitioner violated 42 C.F.R. § 483.30(d), which requires that Petitioner either provide or arrange for physician services to be available 24 hours a day in case of an emergency.  The substantive legal standard is that Petitioner must ensure physician services are always available in the event of an emergency – nothing is unclear about that requirement.

The SOM instructs surveyors that if a resident's attending physician is unavailable, a facility should attempt to contact the physician covering for the attending physician before assuming responsibility for contacting another physician to care for the resident.  Arranging for physician services also includes ensuring that a resident is transported to a hospital emergency room or other medical facility when the long-term care facility is unable to meet the particular needs of the resident.  However, the ability to transport a resident does not relieve a facility of the responsibility to ensure a physician is available 24 hours a day to respond to an emergency that does not require a higher level of care for the resident.  Surveyors are instructed to consider whether a facility has a physician on-call for medical emergencies, which should be either the resident's primary care physician or his or her coverage, and only if neither are available, should a facility undertake to provide the resident with another physician's services.  Surveyors are also instructed to consider whether residents are unnecessarily sent to a hospital emergency room because physician services are unavailable due to the lack of physician availability through Petitioner or inability to contact a physician.  Finally, surveyors are instructed to consider whether the unavailability of physician services had any impact on a resident.  An example cited in the SOM suggests that a facility have a physician under contract to provide emergency services when necessary.  CMS Ex. 31 (SOM, App. PP, Tag F713 (rev. 173, eff. Nov. 28, 2017)).  However, 42 C.F.R. § 483.30(d) does not impose such a requirement, leaving to facility discretion to determine how to ensure emergency services are always available.

The SOM guidance to surveyors does not require that a physician actually be present at the facility to deliver emergency services, allowing direction for the delivery of care and

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services by telephone when necessary or appropriate.  Although it is admittedly hindsight based on current knowledge of the characteristics of SARS-CoV-2 and COVID-19 and changes in CMS policy permitting remote medical consultation by video or otherwise, the characteristics of COVID-19 certainly support the notion that remote delivery is a great idea to help minimize unnecessary exposure of physicians when possible.

In this case, the evidence shows that 90 percent of Petitioner's residents were under the primary care of Dr. Kumar and his PA, PA Carmichael.  Even when Dr. Kumar was unable to enter the facility, he continued to consult with and supervise PA Carmichael.  Findings of Fact 45, 60-61, 63, 68, 80-81.  No requirement for Dr. Kumar to be physically present in the facility has been established by the state or federal statutes or regulations, nor is there evidence of a standard of care or a CMS policy that dictated Dr. Kumar's physical presence so long as PA Carmichael remained within her scope of practice under state law.  There is no evidence that other primary care physicians or their physician extenders were not available at any time or that care and services were not delivered to their patients who were residents.  Even when PA Carmichael was unable to enter the facility due to her infection with COVID-19, the evidence shows that physician services were available from assisting physicians and through emergency rooms.  There is also no evidence that residents were unnecessarily sent to the emergency room.

3.  Petitioner violated 42 C.F.R. § 483.80(a)(1) (Tag F880) (s/s L) because Petitioner failed to implement or maintain its infection control policy.

Pursuant to 42 C.F.R. § 483.80, the substantive legal requirement is that Petitioner must establish and maintain an infection prevention and control program.  The program must be designed to provide a safe, sanitary, and comfortable environment.  The program must also help prevent the development and transmission of communicable diseases and infections.

The surveyors cite Petitioner for violation of 42 C.F.R. § 483.80(a)(1), (2), (4).  CMS Ex. 1 at 39-51; CMS Ex. 2 at 11-15.  The cited provisions of the regulation require:

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

(1) A system for preventing, identifying, reporting, investigating, and controlling infections and communicable diseases for all residents, staff, volunteers, visitors, and other individuals providing

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services under a contractual arrangement based upon the facility assessment conducted according to § 483.70(e) and following accepted national standards;32

(2) Written standards, policies, and procedures for the program, which must include, but are not limited to:

(i) A system of surveillance designed to identify possible communicable diseases or infections before they can spread to other persons in the facility;

(ii) When and to whom possible incidents of communicable disease or infections should be reported;

(iii) Standard and transmission-based precautions to be followed to prevent spread of infections;

(iv) When and how isolation should be used for a resident; including but not limited to:

(A) The type and duration of the isolation, depending upon the infectious agent or organism involved, and

(B) A requirement that the isolation should be the least restrictive possible for the resident under the circumstances.

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(v) The circumstances under which the facility must prohibit employees with a communicable disease or infected skin lesions from direct contact with residents or their food, if direct contact will transmit the disease; and

(vi) The hand hygiene procedures to be followed by staff involved in direct resident contact.

* * * *

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

42 C.F.R. § 483.80(a)(1)-(2), (4).  These provisions of the regulation require that Petitioner establish an IPCP that has the elements specified in the regulation.  In this case only three of the four elements for an IPCP required by the regulation are at issue:  (1) a system for preventing, identifying, reporting, investigating, and controlling infections and communicable diseases among staff, volunteers, residents, visitors, contractors; (2) written standards, policies, and procedures for the IPCP; and (3) a system for recording incidents and corrective actions.  The substantive legal requirements established by the provisions of the regulation in issue are clearly stated.  CMS must present evidence of applicable national standards as part of its prima facie case.  Hillman Rehab., DAB No. 1611 at 8.  CMS's burden to show the applicable standard is satisfied by the fact that Petitioner does not dispute that it follows CDC standards or guidelines.

The surveyors allege in the SOD that Petitioner violated 42 C.F.R. § 483.80(a) because:  Petitioner failed to take appropriate additional actions related to a respiratory illness outbreak; Petitioner failed to take prompt steps to report to the state health department and unspecified local authorities; and Petitioner failed to "operationalize" its IPCP.  CMS Ex. 1 at 41.33   The surveyors allege that infection control was not discussed during meetings to discuss the QAPI program on January 27, 2020, or February 19, 2020, and this fact is not disputed.  CMS Ex. 1 at 49.  The surveyors allege that they interviewed three CNAs and a federal agency staff member who all told the surveyors they had not

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been trained on how to use bleach wipes, and two CNAs and the federal agency staff member did not know how long a surface needed to remain wet after use of a sanitizing wipe for it to be effective.  The surveyors also report that they were told that staff was trained on how to use sanitizing wipes.  CMS Ex. 1 at 49-50.  The surveyors allege that they saw a member of the laundry staff entering and exiting multiple resident rooms delivering clothing, and droplet precaution signs were posted on resident room doors;  the laundry staff member admitted that she did not change PPE between rooms when delivering laundry because she was not direct care staff.  CMS Ex. 1 at 50.  The surveyors state in the SOD that they notified Petitioner's administrator on March 13, 2020, that immediate jeopardy existed due to failed infection control surveillance beginning on February 12, 2020, and the failure to timely report the outbreak to the Health Department to receive guidance and assistance.  The surveyors do not allege in the SOD that Petitioner did not have the required infection control policy and procedures or that they were defective in any respect.  The gist of the allegations is that Petitioner failed to implement its infection control policies and procedures.

Because I conclude that Petitioner failed to implement its infection control policy and procedures as discussed hereafter, it is not necessary to do a detailed analysis of the allegations related to the alleged failure to timely report to the Health Department and receive advice and assistance from that agency; the allegations that staff alleged they had not been trained to use sanitary wipes or did not know the time a surface needed to remain wet for the wipes to be effective; or the allegations related to the failure of laundry staff to change PPE between rooms when delivering clean laundry.  I have already discussed under Tag F684 the basis for my conclusion that Petitioner did timely notify the County Health Department.

The allegations regarding training to use sanitary wipes and how long a surface needed to be wet to be effective, assert no violations of 42 C.F.R. § 483.80, CDC guidelines, state and county health guidelines, or Petitioner's IPCP.  The surveyors' allegations clearly show that staff was using sanitary wipes to clean surfaces from which it may be inferred that they were instructed to use the wipes, and the evidence shows that staff received training on how and where to use them.  Finding of Fact 77.  The surveyors do not allege they observed the sanitary wipes were actually being used incorrectly.  I accept that staff were unable to answer the surveyors' questions about how long a surface needed to remain wet for the sanitization to be effective.  However, the credible evidence shows that the surveyor asking the question used terminology not familiar to Petitioner's staff, resulting in their inability to answer.  Finding of Fact 77.  Absent an allegation that the wipes were incorrectly used, I conclude that the staff's inability to answer the surveyor's question establishes no regulatory violation.

The fact that infection control was not discussed during the January and February 2020 meetings, the purpose for which was to discuss Petitioner's QAPI program, also does not

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show that Petitioner failed to implement its IPCP.  The evidence shows that the ad hoc meetings to discuss the QAPI program in January and February 2020 had a limited purpose and should not be considered to be full agenda QAA meetings.  Furthermore, the weight of the evidence shows that Petitioner's staff was aware of and taking action related to infection control within the facility throughout January and February 2020, even though those efforts were not specifically discussed during the meetings in January and February 2020.  I conclude that the fact infection control was not discussed during the meetings in January and February 2020 does not show that Petitioner failed to implement its IPCP in violation of 42 C.F.R. § 483.80(a)(1).34

The violation of 42 C.F.R. § 483.80(a)(1) occurred in this case when Petitioner failed to ensure its IPCP was fully implemented on February 26, 2020, after it was determined by LPN Cortez and Dr. Kumar that it was necessary to implement interventions to address a suspected outbreak of an unknown pathogen causing a spike in residents with fevers that could not be diagnosed.  The facts placed in evidence by Petitioner are not disputed.  LPN Cortez and Dr. Kumar, in consultation with PA Carmichael, met on February 26, 2020, and decided upon necessary infection control interventions, including requiring group activities be suspended and therapy and activities to be conducted in resident rooms to minimize or prevent the spread of an unknown infection.  Additionally, LPN Cortez posted a sign in the lobby that no visitors were allowed.  Findings of Fact 35, 37, 38.  Upon leaving that meeting, LPN Cortez was alerted to the fact that a Mardi Gras party was planned for that afternoon and a music group was already likely on the way to Petitioner.  The party was permitted to proceed and I infer the visiting musical group performed.  Finding of Fact 39.  Although the evidence shows that distancing was observed, the infection control interventions decided upon prohibited both visitors and group activities and did not make an exception for activities, even if social distancing was observed.  The fact that the Mardi Gras party was permitted to proceed was a serious failure to implement Petitioner's infection control policy in the manner determined by LPN Cortez, Petitioner's infection control nurse, and Dr. Kumar, Petitioner's medical director.

It is inexplicable that the surveyors and CMS made no allegation of noncompliance based on the undisputed fact that the Mardi Gras party was permitted to proceed despite the

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infection control interventions determined to be necessary and that were otherwise immediately implemented.  Petitioner has no grounds to object to my consideration of these facts as Petitioner placed the facts in evidence in the state proceeding through the testimony of LPN Cortez.  The transcript of the state proceeding was placed in evidence in this proceeding by Petitioner.  P. Ex. 1.  The Board made clear in Avon Nursing Home, DAB No. 2830 (2017), that the surveyor's and CMS's view of the evidence are irrelevant to an ALJ's de novo review, except to the extent CMS relies upon unreliable evidence as supporting its findings and conclusions of noncompliance.  The Board explained:

An ALJ decides the noncompliance issue de novo – that is, without deference to CMS's or the state survey agency's factual findings or legal conclusion and based on her own evaluation of the credibility of the submitted evidence.  N.C. State Veterans Nursing Home, Salisbury, DAB No. 2256, at 24 (2009).  Because the ALJ reviews CMS's noncompliance determination de novo, an allegation that the state survey agency used improper methods or personnel to make its findings and conclusions is irrelevant, except to the extent that the state agency's survey practices undermine the credibility of evidence that CMS identifies as supporting the noncompliance determination.

DAB No. 2830 at 12 (2017).  The Board further stated that "the ultimate issue before an ALJ is . . . 'whether the evidence as it is developed before the ALJ supports' CMS's independent 'finding of noncompliance' under the relevant participation requirements."  Avon, DAB No. 2830 at 11 (citing Sunshine Haven Lordsburg, DAB No. 2456 at 21 (2012), aff'd in part and transferred, Sunshine Haven Lordsburg v. U.S. Dept. of Health & Human Servs., 742 F.3d 1239 (10th Cir. 2014)) (emphasis in original).

Accordingly, I conclude that Petitioner violated 42 C.F.R. § 483.80(a)(1) by not implementing its infection control policy.  As discussed, hereafter, Petitioner has not shown that the declaration of immediate jeopardy or the period of immediate jeopardy was clearly erroneous.  I stress again that the evidence does not permit findings of fact or conclusions of the law that the violation permitted, caused, or contributed to the outbreak of COVID-19 at Petitioner.

4.  Petitioner did not violate 42 C.F.R. § 483.70(d)(1)-(2) (Tag F837) (s/s F).

CMS alleges Petitioner violated 42 C.F.R. § 483.70(d)(1)-(2).  The regulation requires that Petitioner have a governing body or designated persons functioning as a governing body.  The governing body is legally responsible for establishing and implementing

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policies for the management and operation of the facility.  The governing body also appoints the facility administrator who meets any state licensure requirements, manages the facility, and is accountable and reports to the governing body.  These substantive legal standards are clear.

The surveyors allege this violation is based on Petitioner's governing body failing to ensure that Petitioner had a QAPI program in 2019.  The surveyors cite as the factual basis that Petitioner did not produce adequate QAA meeting minutes for the required number of meetings in 2019 or that show active medical director participation and attendance per facility policy.  CMS Ex. 1 at 18-24.

I conclude that the preponderance of the evidence shows no violation of 42 C.F.R. § 483.70(d).  There is no allegation that Petitioner did not have a governing body.  I conclude under the discussion of Tag F841 that there is no substantive regulatory requirement that a medical director attend QAA meetings in person and Petitioner's policy and contract with Dr. Kumar created no such requirement.  Dr. Kumar also credibly testified that he was informed of and participated in addressing QAPI issues raised before the QAA committee, and his testimony has not been rebutted.  Furthermore, as discussed hereafter, Petitioner's efforts to correct its QAPI program, efforts that began two months before the survey in this case, may not be the basis for a citation of noncompliance.

5.  Petitioner did not violate 42 C.F.R. § 483.70(h)(1)-(2) (Tag F841) (s/s F).

Pursuant to 42 C.F.R. § 483.70(h)(1)-(2), a facility (whether that is the governing body or administrator is not specified) must designate a physician to serve as medical director.  The medical director is responsible for implementation of resident care policies and the coordination of medical care in the facility.  Nothing is unclear about these substantive legal requirements.  Petitioner must have a medical director and the medical director must be responsible for implementing resident care policies and coordinating resident care.

There is no dispute that Dr. Kumar was Petitioner's medical director.  Findings of Fact 48-56.  However, the surveyors allege that Petitioner did not have an active medical director that participated in Petitioner's QAPI program.

The surveyors allege that Petitioner failed to show that the medical director attended any QAA meetings in 2019, or the two in 2020 prior to the survey.  The surveyors, however, clearly misread the requirement of 42 C.F.R. § 483.75(g)(1)(ii) which provides that the medical director or his or her designee will be a member of the QAA committee, clearly showing it is not necessary for the medical director to attend any QAA committee meetings.  Nothing in 42 C.F.R. § 483.75(g) requires that the medical director have a

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designee appointed on paper or prohibits the medical director from appointing designees on an ad hoc basis to represent him, including designation of another member of the QAA committee to be his designee for a single meeting.  Furthermore, no provision of Dr. Kumar's contract or Petitioner's medical director policy required that he be physically present for a QAA meeting.  Findings of Fact 50-51, 55.

I conclude that Petitioner did not violate 42 C.F.R. § 483.70(h).  I have found no substantive legal requirement that a medical director be physically present for QAA committee meetings and Petitioner's policy and contract with Dr. Kumar do not establish such a requirement.  The evidence shows that Dr. Kumar was informed of and participated in the QAPI process.  Despite the fact he was unable to enter the facility after contracting COVID-19, the evidence shows that he remained available to supervise the care of his patients who were residents of Petitioner, and he remained available to Petitioner's management.  Finding of Fact 60, 64-65.  There is no allegation that Dr. Kumar, in his capacity as medical director, failed to meet the regulatory requirements to implement resident care policies and to coordinate resident care.

6.  Petitioner did not violate 42 C.F.R. §§ 483.20(f)(5) and 483.70(i)(1)-(5) (Tag F842) (s/s F).

CMS alleges that Petitioner violated 42 C.F.R. § 483.20(f)(5) because surveyors saw resident medical records in locations where they might be viewed by the public and an unlocked computer.  CMS Ex. 1 at 29, 31-33.  The regulation prohibits Petitioner from releasing information to the public that can be identified as related to a specific resident.  This prohibition is clear.

CMS also alleges that Petitioner failed to ensure resident medical records were complete and accurate as required by 42 C.F.R. § 483.70(i)(1)-(5).  CMS Ex. 1 at 29-34.  The regulation requires that medical records be maintained for each resident in accordance with accepted professional standards and practices.  The regulation does not specify what are accepted professional standards and practices.  Therefore, CMS was obliged as part of its prima facie case to present evidence to establish accepted professional standards and practices, subject to rebuttal by Petitioner.  Hillman Rehab., DAB No. 1611 at 8.  The regulation does provide some specific criteria, including that medical records for each resident must be complete, accurate, accessible, and organized according to an unspecified system, which may be read as giving Petitioner discretion to adopt an appropriate system if not dictated by professional standards and practices or state law, for example.  The regulation requires that Petitioner keep all information in a resident's records confidential, no matter the form of the record, unless release is to the resident or representative, or as required by law.  Petitioner must safeguard medical record information to prevent loss, destruction, or unauthorized use.  Petitioner must also retain records for specified times.  The regulation requires that a resident's medical record

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contain:  (1) sufficient information to identify the resident; (2)  the record of the resident's assessments; (3) the resident's comprehensive plan of care and services; (4) the results of any preadmission screenings, evaluations or determinations conducted by the state; (5) physician notes, nurse notes, and other licensed professional's notes; and (6) laboratory, radiology, and other diagnostic reports.  The substantive legal standard is clear.

I conclude that the preponderance of the evidence shows that Petitioner did not violate 42 C.F.R. §§ 483.20(f)(5) or 483.70(i)(1)-(5), on either ground alleged by the surveyors.  I consider first the allegation that the surveyor observed resident records that may have been visible to staff who did not have a need to have access.  Capt. Garza testified that on March 8, 2020, he walked the entire facility and observed forms on medication carts, that may have included resident information.  Capt. Garza did not testify about what information he saw.  However, the SOD records that multiple documents with resident identifiable information were observed on medication carts on March 8, 2020.  Capt. Garza alleges that the information was viewable by the public, but he does not allege in the SOD and he did not testify that anyone was actually viewing or in a position to view the information.  CMS Ex. 1 at 22-33.  He also testified that he found a computer unlocked and it is recorded in the SOD that an agency nurse admitted to him that she left the computer unlocked.  CMS Ex. 1 at 3.  He concluded that people without a need to see the information could have seen it, including housekeepers, food services personnel, and maintenance personnel.  He testified that he considered "public," the word used in the regulation, to include anyone who was not a direct care provider and, for that reason, did not have a need to know the information that may have been accessible.  He testified that he interacted with non-direct care providers during the survey, such as housekeepers, one or two building maintenance staff, and kitchen staff.  Tr. 108-10, 144.  Capt. Garza did not testify that he attempted to determine who left the documents with resident information unsecure on medication carts.  Although he testified that he did interact with staff who were not healthcare workers, he did not testify that he actually saw that they were in the area or had access to the information when he made his observations.

I recognize that under prior persuasive Board precedent, the ultimate burden of proof is upon Petitioner.  Arguably, under prior Board decisions, it is not necessary for Capt. Garza to have testified to actually seeing protected resident information or an unauthorized viewer; it is enough for him to simply allege that there was a risk of disclosure.  If that is true, however, the risk should be assessed in light of the facts that existed at the time of the possible violation, including that non-staff were not permitted in the building on March 8, 2020.  Therefore, the risk for viewing by non-staff is arguably non-existent and no violation should be found.

Capt. Garza, however, understood the term public as used in 42 C.F.R. § 483.20(f)(5), to include staff without a need to know the information which might be exposed.  The

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regulations in 42 C.F.R. pt. 483, the regulatory history for 42 C.F.R. § 483.20(f)(5), and the SOM, App. PP, Tag F842 (rev. 173, eff. Nov. 28, 2017) do not define the term public used by the drafters.  Thus, the issue is whether or not, based on the plain language of the regulation, Petitioner was on notice that it must ensure resident information in records is not accessible to staff who have no need to know the information.  Because no definition is provided by the drafters, it is appropriate to consider common meanings for "public" as used in 42 C.F.R. § 483.20(f)(5).  According to Merriam-Webster dictionary, public when used as a noun, as it is in the regulation, means "the people as a whole."35  Black's Law Dictionary defines public as "the people of a nation or community as a whole."  Black's Law Dictionary at 1204 (8th ed. 2004).  Given the common and legal definitions of "public," it is not reasonable to conclude that Petitioner was on notice that it had to meet the stricter standard imposed by Capt. Garza, i.e., that Petitioner had to ensure that no member of its staff without a need to know the information could access the record.  As a practical matter, Capt. Garza's interpretation of the regulation places an unreasonable burden upon Petitioner's staff to ensure that no other staff member walking by a medication cart or workstation might inadvertently look at a record another staff member is using.  Any staff member accessing a record with a need to know would be burdened to ensure that no staff member without a need to know was in the area or would need to screen the record from being seen.  I conclude that 42 C.F.R. § 483.20(f)(5)(i) means exactly what it says, i.e., Petitioner may not release to the public resident-identifiable information and that restriction does not make Petitioner liable for staff access to resident-identifiable information, so long as staff does not disclose the information to the public, i.e., persons other than staff.  Petitioner is obligated to ensure that its staff do not release to the public resident-identifiable information.  DON Earnest testified that staff were trained to ensure they knew the need to protect resident information.  Finding of Fact 75.

The evidence is also undisputed that it was a PHS nurse who failed to secure the records, not Petitioner's staff.  Finding of Fact 75.  I conclude that the actions of a PHS nurse should not be attributed to Petitioner and there is no regulatory violation.

Regarding the allegation that resident records were not timely completed, I also conclude that there was no violation.  Capt. Garza testified that the concern about records not being completed timely was a concern about continuity of care because a hospital receiving a resident needed to know what change of condition occurred at the facility prior to a transfer.  Tr. 96-97.  He agreed that the regulation, 42 C.F.R. § 483.70(i), does not state how quickly medical records should be completed, and for that reason the surveyors look at the facility policy related to documentation.  His recollection of Petitioner's policy is that it required that documentation be completed within one week.  Tr. 97-99.

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Petitioner's policy requires that physician's or a physician extender's progress notes be added to a resident's record no more than a week after the physician's or extender's visit.  Physician orders must be signed within 14 days after the order is issued.  Finding of Fact 57.  Petitioner has another policy that provides that progress notes are recorded when a resident is seen or when there is a change in condition.  Orders must be signed by a physician within 14 days of issuance.  Finding of Fact 58.

The SOM, App. PP, Tag F842, states:

Except for the annual comprehensive assessment, periodic reassessments when a significant change in status occurs, and quarterly monitoring assessments, regulations do not define the documentation frequency of a resident's progress. Professional standards of practice however suggest documentation include a resident's care plan implementation progress.

The SOM instructs surveyors that "[w]hen reviewing a resident's medical record, determine if the record, including any archived information, is accessible to and provides sufficient information for appropriate staff to respond to the changing status and needs of the resident."  This standard is consistent with the outcome-based nature of the survey process.  42 C.F.R. § 488.26(c)(2).  It does not instruct surveyors to check resident records to ensure that progress notes and orders were completed within a specified number of days.  Rather, surveyors are instructed to consider whether at any given time the resident records permit staff to respond to the needs of the resident.  In this case, Capt. Garza's testimony and CMS Ex. 20 show that the surveyors departed from the outcome-based evaluation required by the regulations in favor of counting the number of times they found that resident records were not perfect as defined by Petitioner's policy.  In the SOD, the surveyors allege specifically that residents 131, 136, 141, 152, 156, and 160 were transferred to the hospital and their records lacked evidence of medical assessments prior to their transfers.  CMS Ex. 1 at 33-34.  I read the allegation not as alleging that no assessment was done, but rather, that the assessments prior to the transfers were not documented.

Petitioner does not dispute that not every progress note was updated within a week during the emergency with notes being made on note pads with updates to the electronic medical records having to wait until the emergency passed.  Finding of Fact 74(n).  DON Earnest testified credibly, and her testimony is not rebutted that she checked the record for each resident identified by the surveyors, and she found all information necessary for resident care.  Finding of Fact 74(o).  The evidence shows that information necessary for continuity of care was transmitted to receiving hospitals and there is no evidence that any

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resident did not receive quality care due to some record not being completed on time.  Finding of Fact 74(p)-(r).

I conclude based on a preponderance of the evidence that there was no violation of 42 C.F.R. §§ 483.20(f)(5) and 483.70(i)(1)-(5) and no noncompliance under Tag F842.

7.  Even if Petitioner's QAPI program did not satisfy the requirements of 42 C.F.R. § 483.75 (Tag F865) (s/s F), no enforcement remedy may be imposed pursuant to 42 C.F.R. § 483.75, based on Petitioner's good faith attempts to identify and correct its QAPI deficiency.

Petitioner is required to have a QAPI program by 42 C.F.R. § 483.75(a).  Petitioner "must develop, implement, and maintain an effective, comprehensive, data-driven QAPI program that focuses on indicators of the outcomes of care and quality of life."  42 C.F.R. § 483.75(a).  Specific requirements for a QAPI program are listed in the regulation.

The surveyors allege in the SOD that Petitioner violated 42 C.F.R. § 483.75(a)(2), (h), and (i).  CMS Ex. 1 at 34-39.  However, 42 C.F.R. § 483.75(a)(2) requires that a facility present its QAPI plan to the state agency within one year after the regulation was effective, which was on November 28, 2016.  81 Fed. Reg. 68,688.  The SOD includes no allegation that Petitioner failed to timely present its QAPI plan to the state agency and there is no evidence the state agency ever found Petitioner's QAPI program deficient in the past.

Under 42 C.F.R. § 483.75(h), the state agency or the Secretary may not require the disclosure of QAA committee records, except to determine whether the QAA committee is complying with the requirements of 42 C.F.R. § 483.75.  Pursuant to 42 C.F.R. § 483.75(i), "[g]ood faith attempts by the [QAA] committee to identify and correct quality deficiencies will not be used as a basis for sanctions."  42 C.F.R. § 483.75(i) (emphasis added).

The surveyors allege that Petitioner violated the requirements for a QAPI program because it failed to develop a QAPI program to identify and correct quality deficiencies and opportunities for improvement, evidenced by the fact that Petitioner did not produce evidence of a sufficient number of QAA meetings in 2019 and evidence that the medical director attended meetings in 2019 and 2020.  CMS Ex. 1 at 34.  The SOD states that Petitioner's Administrator told them that when she became Petitioner's Executive Director in January 2020, she identified that Petitioner's QAPI program was deficient, and she was working to make corrections.  CMS Ex. 1 at 36; Findings of Fact 69-72.

The Board has commented that the Secretary's purpose for not permitting sanctions for good faith efforts by a facility to correct quality deficiencies is to "encourage the kind of

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systemic actions that can improve quality of care, not to insulate facilities that fail to properly care for residents . . . ."  Sunshine Haven Lordsburg, DAB No. 2456 at 2936 (2012).

The SOM directs surveyors as follows:

Surveyors must use critical thinking and investigatory skills to identify noncompliance, rather than using information provided during the QAA37 review as a source to identify deficiencies. The intent of §483.75(h), (i) is to:

• Ensure information obtained from QAA committee documents that is related to the committee's good faith attempt to identify and correct quality deficiencies are not used by surveyors to identify additional concerns not previously identified during the survey; and
• Foster a culture where nursing homes can openly conduct their internal QAA investigations and performance improvement efforts.
  
  Surveyors may only require facilities to disclose QAA committee records if they are used to determine the extent to which facilities are compliant with the provisions for QAA.

SOM, App. PP, Tag F865 (rev. 173, eff. Nov. 28, 2017).  CMS Ex. 34 at 3.

Under 42 C.F.R. § 483.75(h), surveyors may require facilities to disclose QAA committee records if they are used to determine the extent to which facilities are compliant with the requirements of 42 C.F.R. § 483.75.  The requirements for the QAA committee found in 42 C.F.R. § 483.75(g) are membership of the required personnel, duty to report on the QAPI program to the facility's governing body or its designee, a

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minimum of quarterly meetings, developing and implementing plans to correct identified quality deficiencies, and regular review and analysis of data collected under the QAPI program.  The surveyors' allegations are that the QAA committee did not meet quarterly in 2019 because Petitioner could not produce evidence it did.  There is no dispute that the surveyors were entitled to request and receive documentation reflecting the required number of meetings in 2019, agenda, and attendance.  Petitioner did not produce evidence that a sufficient number of meetings were held in 2019, showing by a preponderance of the evidence a violation of 42 C.F.R. § 483.75(g)(2)(i).

The SOM further instructs surveyors:

The key point is that the facility must provide satisfactory evidence that it has, through its QAA committee, identified its own high risk, high volume, and problem-prone quality deficiencies, and are making a "good faith attempt" to correct them.  Information gleaned from disclosure of QAA committee documents will not be used to cite new issues (not already identified by the survey team) or to expand the scope or severity of concerns identified on the current survey.  NOTE:  Prior to conducting the QAA review, the survey team must conduct a thorough investigation of all issues identified, including expanding the sample as necessary to determine the scope of the issue.

SOM, App. PP, Tag F865 (rev. 173, eff. Nov. 28, 2017).

In this case, the surveyors were permitted by 42 C.F.R. § 483.75(h) to request disclosure of QAA committee records to determine whether or not Petitioner was complying with the requirements of 42 C.F.R. § 483.75.  Petitioner has failed to present credible evidence that its QAA committee met at least quarterly in 2019.  Accordingly, Petitioner has failed to show by a preponderance of the evidence that it was in compliance with 42 C.F.R. § 483.75.

However, the evidence shows Administrator Basham, who is an authorized member of Petitioner's QAA committee and responsible to the governing body, identified deficiencies in Petitioner's QAPI program, including that Petitioner did not have consistent and effective QAA meetings in 2019.  Findings of Fact 69-72.  Administrator Basham convened an ad hoc meeting on January 27, 2020, with a follow-up meeting on February 19, 2020; the stated purpose was to consider improvement of Petitioner's QAPI program because Petitioner had not conducted consistent or effective QAA meetings during the past year; and a plan for regular meetings to identify and address QAPI issues was developed.  CMS Ex. 14 at 1-7, 21; Finding of Fact 71.  I conclude that the evidence

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shows that Administrator Basham had identified a quality deficiency related to Petitioner's QAPI program and that she had undertaken good faith efforts before the survey began to correct the quality deficiency.  I further conclude that the Secretary's prohibition upon imposing an enforcement remedy established by 42 C.F.R. § 483.75(i) is triggered and no enforcement remedy may be imposed on this basis.

8.  Petitioner has not met its burden to show that the declaration of immediate jeopardy from February 26, 2020, (the date I conclude noncompliance began) to March 28, 2020, (when immediate jeopardy was abated) due to the noncompliance under 42 C.F.R. § 483.80(a)(1) (Tag F880), was clearly erroneous.

CMS alleges that noncompliance that posed immediate jeopardy began as early as February 12, 2020.  CMS Ex. 4 at 2.  I have concluded that Petitioner's noncompliance under 42 C.F.R. § 483.80(a)(1) began on February 26, 2020, the date Petitioner failed to implement its infection control plan by failing to restrict visitors and limit activities to resident rooms.  There is no dispute that the surveyors found that immediate jeopardy was abated on March 28, 2020, based on a revisit survey concluded on March 29, 2020.  CMS Exs. 2 at 1-2, 4 at 1.  Therefore, the issue is whether the determination that Petitioner's noncompliance under 42 C.F.R. § 483.80(a)(1) posed immediate jeopardy during the period February 26 through March 27, 2020, is clearly erroneous.  Petitioner bears a heavy burden to show that the declaration of immediate jeopardy 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."  42 C.F.R. §§ 488.301, 489.3 (emphasis added).  In the context of survey, certification, and enforcement related to SNFs and NFs, a conclusion by the state agency and CMS that noncompliance with program participation requirements poses immediate jeopardy to the facility residents triggers specific regulatory provisions that require enhanced enforcement remedies, including authority for CMS to impose a larger CMP than may be imposed when there is no declaration of immediate jeopardy.  42 C.F.R. §§ 488.408(e), 488.438(a)(1)(i), (c), 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.  42 C.F.R. §§ 488.410, 488.440(g), 488.456, 489.53(d)(2)(B)(ii).

Pursuant to 42 C.F.R. § 498.3(d)(10), a finding by CMS that deficiencies pose immediate jeopardy to the health or safety of a facility's residents is not an initial determination that triggers a right to request a hearing by an ALJ or that is subject to review.  Rather, a finding of noncompliance that results in the imposition of an enforcement remedy, except the remedy of monitoring by the state, triggers a right to request a hearing and is subject

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to review.  42 C.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.  42 C.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.  42 C.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 , DAB No. 2384 at 14 ; Brian Ctr. Health , DAB No. 2336 at 9 (citing Barbourville Nursing Home, DAB No. 1962 at 11 (2005), aff'd, Barbourville Nursing Home v. U.S. Dep't of Health & Human Servs., 174 F. App'x 932 (6th Cir. 2006)); Maysville Nursing , DAB No. 2317 at 11; 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."38   In Mississippi Care Ctr. of Greenville, DAB No. 2450 at 15 (2012), the Board commented:

CMS's determination that a deficiency constitutes immediate jeopardy must be upheld unless the facility is able to prove that the determination is clearly erroneous.  42 C.F.R. § 498.60(c)(2); Woodstock Care Center.  The "clearly erroneous" standard means that CMS's immediate jeopardy determination is presumed to be correct, and the burden of proving the determination clearly erroneous is a heavy one.

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

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

We believe that a provider's burden of upsetting survey findings relating to the level of noncompliance should be high, however.  As we indicated in the proposed rule, distinctions between different levels of noncompliance, whether measured in terms of their frequency or seriousness, do not represent mathematical judgments for which there are clear or objectively measured boundaries.  Identifying failures in a facility's obligation to provide the kind of high quality care required by the Act and the implementing regulations most often reflect judgments that will reflect a range of noncompliant behavior.  Thus, in civil money penalty cases, whether deficiencies pose immediate jeopardy, or are widespread and cause actual harm that is not immediate jeopardy, or are widespread and have a potential for more than minimal harm that is not immediate jeopardy does not reflect that a precise point of noncompliance has occurred, but rather that a range of noncompliance has occurred which may vary from facility to facility.  While we understand the desire of those who seek the greatest possible consistency in

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

In the aforementioned quotation from Mississippi Care Ctr. of Greenville, 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 at 269 (8th ed. 2004).  The Supreme Court has addressed the "clearly erroneous standard" in the context of the APA.  The Court described the preponderance of the evidence standard, the most common standard, as requiring that the trier-of-fact believe that the existence of a fact is more probable than not before finding in

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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, 508 U.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, 527 U.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.39   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, DAB No. 2347 at 19, (citing Life Care Ctr. of Tullahoma, DAB No. 2304 at 58 (2010), aff'd, Life Care Ctr. of Tullahoma v. Sec'y of U.S. Dep't of Health & Human Servs., 453 F. App'x 610) (6th Cir. 2011)).  The definition of immediate jeopardy at 42 C.F.R. § 488.301 does not define "likelihood" or establish any temporal parameters for potential harm.  Agape Rehab., DAB No. 2411 at 18-19.  The duration of the period of immediate jeopardy is also subject to the clearly erroneous standard.  Brian Ctr. Health, DAB No. 2336 at 7-8.  There is a difference between "likelihood" as required by the definition of immediate jeopardy and a mere potential.  The synonym for likely is probable, which suggests a greater degree of probability that an event will occur than suggested by such terms as possible or potential.  Daughters of Miriam Ctr., DAB No. 2067 at 10.  Jeopardy generally means danger, hazard, or peril.  The focus of the immediate jeopardy determination is how imminent the danger appears and how serious the potential consequences.  Woodstock Care Ctr., DAB No. 1726.

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What is the meaning of serious injury, harm, or impairment as used in the definition of immediate jeopardy found in 42 C.F.R. § 488.301?  How does serious injury, harm, or impairment compare with "actual harm"?  On the first question, the Board recognized in Yakima Valley Sch., 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 42 C.F.R. § 483.80(a)(1), 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 February 26 through March 27, 2020.

Petitioner has the burden to show the declaration of immediate jeopardy was clearly erroneous and has failed to meet that burden.  The evidence shows that on February 26, 2020, the determination was made by LPN Cortez, Petitioners' infection control nurse, in consultation with Dr. Kumar, Petitioner's medical director, that Petitioner should be closed to visitors immediately, activities should be restricted, and residents should remain in their rooms.  Nevertheless, a Mardi Gras party with a visiting band was permitted to proceed that very afternoon.  Although LPN Cortez testified that distancing was observed that condition was not contemplated by the infection control plan that was agreed to and implemented prior to the party.  Whether or not the Mardi Gras party contributed to the spread of COVID-19 in Petitioner's facility cannot be determined based on the evidence.  All that is required for a finding of immediate jeopardy is a finding that there was or is a likelihood of serious injury, harm, impairment, or death.  Petitioner has not shown that the possible harm met no reasonable definition of serious or that it was not likely.

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Petitioner has not shown as clearly erroneous the determination that there was a likelihood for serious harm or death as a result of proceeding with the Mardi Gras party.

Accordingly, I conclude that Petitioner remained out of compliance at the immediate jeopardy level from February 26 through March 27, 2020.  Petitioner has not met its burden to show that the determination regarding the duration of the period of immediate jeopardy was clearly erroneous.

9.  A CMP of $13,585 per day from February 26 through March 27, 2020, is a reasonable enforcement remedy.

10.  A DPNA for the period March 21 through 27, 2020, is also a reasonable enforcement remedy, but Petitioner concedes it had no effect as Petitioner admitted no new residents during that period.

I have concluded that Petitioner violated 42 C.F.R. § 483.80(a)(1) 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 noncompliance based on the violation of 42 C.F.R. § 483.80(a)(1) was clearly erroneous during the period February 26 through March 27, 2020.

CMS argues that immediate jeopardy noncompliance began on February 12, 2020.  CMS Ex. 4 at 2; CMS Br. at 25.  I have concluded, however, that noncompliance based on the violation of 42 C.F.R. § 483.80(a)(1) began on February 26, 2020, rather than February 12, 2020.  CMS found, based on a revisit survey, that Petitioner abated the immediate jeopardy as of March 28, 2020.  CMS Exs. 2 at 2, 4 at 1.  The CMP proposed by CMS in this case ends on March 27, 2020, the day before the date on which Petitioner abated immediate jeopardy.  CMS Ex. 4 at 2.  The DPNA also ended on March 27, 2020.  CMS Ex. 4 at 3.  No enforcement remedy was imposed for noncompliance during the period March 28, 2020 and July 1, 2020, when the parties agree that CMS found that Petitioner returned to substantial compliance (Jt. Stip. ¶ A.10), and there is no enforcement remedy subject to review for that period.

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 is reasonable under the regulatory factors and can change the amount if they find the CMP is not reasonable based on the factors.  However, ALJs and the Board cannot eliminate the CMP or reduce it to zero under 42 C.F.R. § 488.438(3)(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).

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The Secretary has also provided by regulation that CMS's choice of sanctions to impose, including whether a CMP is to be imposed per day or per instance, is not subject to review.  42 C.F.R. §§ 488.408(g)(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 42 C.F.R. § 488.406, including a CMP.  CMS may impose a per day CMP for the number of days that the facility is not in compliance or a per instance CMP for each instance that a facility is not in substantial compliance, whether or not the deficiencies pose immediate jeopardy.  42 C.F.R. § 488.430(a).  The regulations specify that a CMP that is imposed against a facility on a per day basis will fall into one of two ranges of penalties.  42 C.F.R. §§ 488.408, 488.438.  The upper range of a CMP, $6,808 per day to $22,320 per day, is reserved for deficiencies that pose immediate jeopardy to a facility's residents and, in some circumstances, for repeated deficiencies.  42 C.F.R. § 488.438(a)(1)(i), (d)(2); 45 C.F.R. § 102.3 (Table) (2020).

If I conclude, as I have in this case, that there is a basis for the imposition of an enforcement remedy and the remedy proposed is a CMP, my authority to review the reasonableness of the CMP is limited by 42 C.F.R. § 488.438(e).  The limitations are that  I may:  (1) not set the CMP at zero or reduce it to zero; (2) not review the exercise of discretion by CMS in selecting to impose a CMP; and (3) only consider the factors specified by 42 C.F.R. § 488.438(f) when determining the reasonableness of the CMP amount.

In determining whether the amount of a CMP is reasonable, the following factors specified at 42 C.F.R. § 488.438(f) must be considered:  (1) the facility's history of noncompliance, including repeated deficiencies; (2) the facility's financial condition; (3) the seriousness of the deficiencies as set forth at 42 C.F.R. § 488.404(b), the same factors CMS and/or the state were to consider when setting the CMP amount; and (4) the facility's degree of culpability, including but not limited to the facility's neglect, indifference, or disregard for resident care, comfort, and safety, and the absence of culpability is not a mitigating factor.

The factors that CMS and the state were required to consider when setting the CMP amount and that I am required to consider when assessing the reasonableness of the amount are set forth in 42 C.F.R. § 488.404(b):  (1) whether the deficiencies caused no actual harm but had the potential for minimal harm, no actual harm with the potential for more than minimal harm, but not immediate jeopardy, actual harm that is not immediate jeopardy, or immediate jeopardy to resident health and safety; and (2) whether the deficiencies are isolated, constitute a pattern, or are widespread.

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My review of the reasonableness of the CMP is de novo and based upon the evidence in the record before me.  I am not bound to defer to the CMS determination of the reasonable amount of the CMP to impose, but my authority is limited by regulation 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).

I have received no evidence that Petitioner had a history of noncompliance prior to the survey at issue.  Petitioner has not argued that its financial condition affects its ability to pay the proposed CMP.  I conclude that Petitioner's noncompliance was serious and posed immediate jeopardy for all of Petitioner's residents.  Petitioner was culpable because the Mardi Gras party was permitted to proceed despite the fact that LPN Cortez and Dr. Kumar had determined it was necessary to:  suspend activities; deliver meals, therapy, and activities in resident rooms; and close the facility to all visitors.  By failing to act in accordance with the determination of its medical director and infection control nurse, Petitioner failed to implement its infection control policy and procedure and violated 42 C.F.R. § 483.80(a)(1), which posed a risk for serious harm or death for all Petitioner's residents.

The CMP of $13,585 per day proposed by CMS for immediate jeopardy during the period February 12 through March 27, 2020 is not reasonable because the preponderance of the evidence shows that the noncompliance in this case began on February 26, 2020, not February 12, 2020.  Petitioner has not shown that it abated the immediate jeopardy before March 27, 2020, i.e., Petitioner has not shown before me that it recognized the violation that occurred when the interventions decided upon by LPN Cortez and Dr. Kumar were not implemented or that it took action to prevent such a violation in the future.  A CMP of $13,585 per day is reasonable for the period February 26, 2020, when immediate jeopardy level noncompliance began, through March 27, 2020, when immediate jeopardy was abated.  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.  42 C.F.R. § 488.438(a)(1)(i), (d)(2); 45 C.F.R. § 102.3 (Table) (2020).  A CMP of $13,585 is slightly above the middle of the authorized range and reasonable based on my consideration of the regulatory factors.

I also conclude that the DPNA imposed for the period March 21, 2020 through March 27, 2020, is a reasonable enforcement remedy based on the same analysis of the regulatory factors.  Petitioner represents that Petitioner admitted no residents during that period, effectively avoiding the impact of the DPNA.  P. Br. at 5.

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I have concluded that Petitioner was not in substantial compliance with only one of the three allegations of noncompliance at the immediate jeopardy level advanced by CMS as a basis for a per day CMP of the same amount.  Nevertheless, I conclude, based on my review of the regulatory factors, specifically, the seriousness of the noncompliance, that the daily CMP amount of $13,585 for the reduced period is reasonable.  The Board has recognized that an ALJ has the discretion to make such a determination.  Franklin Care Ctr., DAB No. 1900 at 7 (2003).

Petitioner is ineligible to be approved to conduct a NATCEP for a period of two years beginning March 16, 2020, due to the amount of the CMP approved.  42 C.F.R. § 483.151(b)(2)(iv) and (f)(1).  The ineligibility to be approved to conduct a NATCEP is not an enforcement remedy.  42 C.F.R. § 488.406.

Petitioner challenges "the Board's policy that permits CMS to impose civil monetary penalties without offering evidence that it considered the regulatory criteria set forth at 42 C.F.R. §§ 488.404 and 488.438(f) as a violation of the Medicare Act and due process of law."  RFH at 18.  Petitioner points to no authority that permits me to review whether CMS correctly considered the regulatory factors.  How CMS considered the regulatory factors is really not relevant because I conduct a de novo review of the factors, i.e., I do a fresh look at the factors, considering whatever evidence and arguments Petitioner advances for how the factors should be weighed in determining reasonable enforcement remedies.

IV.  Conclusion

For the foregoing reasons, I conclude that:

Petitioner violated 42 C.F.R. § 483.80(a)(1) beginning on February 26, 2020, by failing to ensure its infection control policy was implemented.  The violation continued until July 1, 2020.  The violation posed immediate jeopardy from February 26 through March 27, 2020.

There is a basis for the imposition of enforcement remedies.  A CMP of $13,585 per day for the period February 26 through March 27, 2020, is a reasonable enforcement remedy.  A DPNA from March 21 through 27, 2020, is also reasonable.

1. References are to the 2019 revision of the Code of Federal Regulations (C.F.R.), unless otherwise indicated.  In Mark A. Kabat, D.O., DAB No. 2875 at 9-11 (2018), an appellate panel of the Departmental Appeals Board (Board), after reviewing prior Board decisions, expressed a preference for applying the regulations in effect at the time of agency action rather than at the time of the events that were the basis for the agency action, at least in provider and supplier revocation cases.  Other 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 revision of 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).  In this case, the events for which immediate jeopardy was alleged occurred in February and March 2020.  The regulations with which Petitioner was bound to comply during the period were in the 2019 revision of the C.F.R.
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2. The evidence, including documents and testimony, can be confusing in this case due to inconsistencies in references to the virus and disease that are involved in this case.  Confusion is also possible given that the Centers for Medicare & Medicaid Services (CMS) and the Centers for Disease Control and Prevention (CDC) materials also discuss the 2003 occurrence of SARS-CoV (severe acute respiratory syndrome coronavirus).  In its February 6, 2020 memorandum to State Survey Agency Directors, CMS refers to the "2019 Novel Coronavirus (2019-nCoV)."  CMS Ex. 37; P. Ex. 17.  Subsequently, on February 11, 2020, the World Health Organization (WHO), which maintains the International Classification of Diseases, announced that SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) (named by the International Committee on Taxonomy of Viruses) is the name of the virus that causes the coronavirus 2019 (COVID-19) disease (named by the WHO).  https://www.who.int/emergencies/diseases/novel-coronavirus-2019/technical-guidance/naming-the-coronavirus-disease-(covid-2019)-and-the-virus-that-causes-it (last visited Aug. 27, 2021).  In this decision, "SARS-CoV-2" or "the virus" is used to refer to the virus rather than "2019-nCoV" or "2019 Novel Coronavirus."  "COVID-19" is used to refer to the disease caused by the virus.  "Asymptomatic" or "pre-symptomatic resident" refers to one infected with SARS-CoV-2 but not manifesting the signs and symptoms of COVID-19.  "Covid" or "coronavirus" is not used in this decision because the CDC identifies seven coronaviruses and related diseases that are common, including Middle East Respiratory Syndrome (MERS) coronavirus and SARS-CoV.  https://www.cdc.gov/coronavirus/types.html (last visited Aug. 27, 2021).
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3. Rulings Granting Petitioner's Motion to Expedite, Identifying Issues for Adjudication, and Identifying Authorized Parties, and Order Setting Hearing, May 4, 2020.
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4. Ruling Denying Cross-Motions for Summary Judgment, Jan. 26, 2021.
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5. There are two documents marked CMS Ex. 30, one of which is Departmental Appeals Board Electronic Filing System (DAB E-File) Item # 17_b (Declaration of William Schwartzman, MD) and the other is DAB E-File Item # 29_b (excerpt from the State Operations Manual (SOM)).  To minimize confusion if citation to either is necessary, the former will be referred to as CMS Ex. 30 (Schwartzman) and the latter CMS Ex. 30 (SOM).  Tr. 45-47.  It is also noted that P. Ex. 49 is incorrectly marked on the document as P. Ex. 48 and that document will be cited as P. Ex. 49 as it was filed (DAB E-File Item #14_c9).  Tr. 48-49.
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6. 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.
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7. 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).
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8. 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 similar to 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.
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9. I recognize that Petitioner's citation to Kisor may be intended to preserve an issue for further appeal in the federal courts.
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10. To be clear, I recognize that there is a limit to my authority as an ALJ.  ALJs and the Board do not have authority to ignore unambiguous statutes or regulations on grounds that they are unconstitutional (or in this case not promulgated in accordance with section 1871 of the Act), even though the ALJ and the Board may believe that the statute or regulation is unconstitutional (or not properly promulgated).  ALJs and the Board are bound by regulations issued by their agency.  Sentinel Med. Labs., Inc., DAB No. 1762 at 6 (2001), aff'd sub nom., Teitelbaum v. Health Care Fin. Admin., 32 F. App'x 865 (9th Cir.  2002), reh'g denied, No. 01-70236 (9th Cir. May 22, 2002).
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11. There is no dispute the federal surveyors did not testify in the state ALJ proceeding though the state surveyors did.  The state ALJ decision does not indicate whether either party attempted to subpoena the federal surveyors under the Washington Administrative Procedure Act (APA) (Wash. Rev. Code § 34.05.446) or followed the procedures of 45 C.F.R. pt. 2.  The Revised Code of Washington is available at https://apps.leg.wa.gov/rcw/ (last update Dec. 7, 2020).  The Washington Administrative Code is available at https://apps.leg.wa.gov/wac/ (last update Dec. 23, 2020).
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12. I conclude that there were no violations of federal regulations related to emergency physician services or the use of sanitizing wipes for reasons discussed hereafter.
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13. CMS has not requested that Petitioner be collaterally estopped from relitigating the state ALJ's findings regarding physician services or staff training.
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14. Issue preclusion is another term for collateral estoppel.  Res judicata (claim preclusion) and collateral estoppel are not synonymous.  Black's Law Dictionary 279, 1336-37 (8th ed. 2004); Garner's Dictionary of Legal Usage 171-72 (3rd ed. 2011).
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15. It is clear that Parklane has no real application in this case.  In this case, Petitioner was a party to the state ALJ proceeding.  CMS was not.
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16. Stauffer has to do with mutual defensive collateral estoppel and has no application in this case.
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17. The goal of separating the factual analysis necessary to make findings of fact from the legal analysis necessary to address the alleged noncompliance is to make this decision less confusing for the reader, including those conducting appellate review.  The legal analysis for each allegation of noncompliance refers to these findings of fact rather than including a detailed evidentiary analysis.
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18. "Credible evidence" is evidence that is worthy of belief.  Black's Law Dictionary at 596 (18th ed. 2004).  The "weight of evidence" is the persuasiveness of some evidence compared to other evidence.  Id. at 1625.
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19. 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.  Some excerpts from the SOM are in evidence as CMS Exs. 30-35.  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.
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20. 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, specifies which remedies are required and optional at each level based upon the frequency of the deficiency.
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21. SARS-CoV is the coronavirus that causes SARS.  SARS-CoV-2 is the coronavirus that causes COVID-19.
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22. The complete guidelines are available at https://www.cdc.gov/infectioncontrol/guidelines/isolation/index.html (last visited Sep. 16, 2021).
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23. The citation is to a prior version of the infection control regulation.  The infection control regulation is currently 42 C.F.R. § 483.80.
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24. A CDC fact sheet on SARS, which is not in evidence and is included here only as background information, states that SARS-CoV was first reported in Asia in February 2003.  The illness spread to more than two dozen countries in North America, South America, Europe, and Asia before it was contained.  According to the WHO, 8,098 people became sick with SARS-CoV during the 2003 pandemic with 774 deaths.  In the U.S., only eight people had laboratory evidence of SARS-CoV, all of whom had traveled to locations where SARS was spreading.  https://www.cdc.gov/sars/about/fs-sars.html (last visited Sep. 23, 2021).  According to the Merriam-Webster Dictionary, an epidemic is an outbreak of a disease that spreads quickly and affects a large number of individuals within a population, community, or region at the same time.  https://www.merriam-webster.com/dictionary/epidemic (last visited Sep. 23, 2021).  A pandemic is an outbreak of a disease that occurs over a wide geographic area such as multiple countries or continents, affecting a significant portion of the population.  https://www.merriam-webster.com/dictionary/pandemic (last visited Sep. 23, 2021).
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25. The article includes a graphic that lists the first nine long-term care facilities in King County with one or more cases of COVID-19.  All nine were identified by a positive COVID-19 test between February 28, 2020 (Petitioner's first positive test) and March 8, 2020, when four other facilities had positive tests.  On March 1, 2020, a facility that shared a health care worker with Petitioner had a positive test.  On March 5, 2020, two facilities who received a resident from Petitioner also each had a positive test.  On March 7, 2020, another facility that shared a health care worker with Petitioner had a positive test.  The chart reflects no known connection between Petitioner and the four facilities that had residents test positive on March 8, 2020.  The graphic clearly states that the direction of potential travel of COVID-19 from one facility to another is unknown.  It is not stated in the graphic and accompanying text whether the infections had a common source (genetic identity).  P. Ex. 14 at 5.
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26. In the State of Washington there is a state health department and a county or local health department.  The local or county health departments are not part of the state health department, but the state health department is required to work with the local departments.  Wash. Rev. Code Ann. §§ 43.70.020(3)(a), 43.70.140; https://www.doh.wa.gov/AboutUs/PublicHealthSystem#heading73023 (last visited Aug. 25, 2021); P. Ex. 8 at 11-13.  However, by statute, the Washington public health system is comprised of the state department of health, local health jurisdictions, sovereign tribal nations, Indian health programs, and the state board of health.  Wash. Rev. Code Ann. § 43.70.512(1).  Due to imprecise questioning and responses, it is not always possible to determine whether a witness refers to the state or county agency.  Where possible, the distinction is made.  However, in most cases, the distinction has no impact on the evaluation of the evidence or the decision in this case and no distinction is attempted.
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27. "Universal precautions" is a term used by the Occupational Safety and Health Administration (OSHA) to refer to precautions that must be implemented in a healthcare employer setting to protect patients and medical staff against blood borne pathogens.  "Standard precautions" is a term used by the CDC to describe interventions to reduce the spread of infectious diseases.  While the terms are not interchangeable, the precautions overlap.  Https://www.oshamanual.com/compliance101/article/standard-vs.-universal-precautions (last visited Sep. 27, 2021).
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28. LPN Cortez's handwritten notes dated February 27, 2020, actually reflect three recommendations:  use of disposable utensils, limit admissions, and droplet precautions.  LPN Cortez's notes also mention COVID-19.  P. Ex. 38 at 2.
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29. Petitioner is required to have a Quality Assessment and Performance and Improvement (QAPI) program.  42 C.F.R. § 483.75(a).  Petitioner is required to have a Quality Assurance and Assessment (QAA) committee as part of its QAPI program.  42 C.F.R. § 483.75(g).
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30. I recognize that diagnoses of lower respiratory infection or pneumonia do not rule out the possibility that the cause was SARS-CoV-19.  However, there is no evidence that SARS-CoV-19 was more likely than not the cause.  In fact, no underlying cause may be determined based on the evidence of record.
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31. Even if I were to accept that all the other allegations of the surveyors were established by the evidence, which I do not, conclusions that Petitioner's failings caused residents to be transferred to hospitals and the death of many are not supportable in this case.  The record simply does not include enough medical evidence, expert opinion, or knowledge of SARS-CoV-2 and COVID-19 to support such conclusions.  The credibility of the survey process; the knowledge, skills, and professionalism of surveyors; and the government agency tasked with regulating the health care industry are all damaged by such assertions, which are not based on the facts and the science and verge on being irresponsible.  Nevertheless, there is sufficient evidence to conclude that the outbreak of infection in a facility poses a risk for serious harm or, possibly death, if the infection is sufficiently virulent as is the case with SARS-CoV-2, MERS, tuberculosis, and others.
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32. Specific national standards are not identified by the regulation.  This fact is consistent with the CMS position that a facility should have discretion to select the national standard it will apply.  81 Fed. Reg. at 68,808.  In this case, the parties agree that CDC standards or guidelines are applicable to Petitioner.

Petitioner was not cited for failure to do and document the "facility-wide assessment to determine what resources are necessary to care for its residents competently during both day-to-day operations and emergencies" as required by 42 C.F.R. § 483.70(e).  CMS Ex. 1.
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33. The SOD also cites violations of 42 C.F.R. § 483.80(e) (handling, storing, processing, and transporting linens) and (f) (facility must review IPCP annually).  CMS Ex. 1 at 39-41; CMS Ex. 2 at 11-13.  However, the SOD does not actually allege facts that would constitute violations of 42 C.F.R. § 483.80(e) and (f) and these provisions are not considered at issue.  CMS Ex. 1 at 41; CMS Ex. 2 at 11-13.
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34. This noncompliance arguably falls within the broad umbrella of quality of care, which is required by 42 C.F.R. § 483.25, due to the possible exposure of a greater number of residents to infection.  However, the failure of Petitioner to implement its IPCP is not specifically alleged by the surveyors as a basis for a violation of 42 C.F.R. § 483.25.  Further, I would not consider a violation of 42 C.F.R. § 483.25 based on failure to implement the IPCP program to be an additional and cumulative ground to increase the CMP that I approve in this case.
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35. Https://www.merriam-webster.com/dictionary/public (last visited Oct. 12, 2021).
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36. The Board was commenting upon 42 C.F.R. § 483.75(o)(4).  The number of the regulation was changed to 42 C.F.R. § 483.75(i) by the revisions to the regulations in 2016, which made no substantive change to the text.  81 Fed. Reg. at 68,831.
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37. Pursuant to 42 C.F.R. § 483.75(g), a facility's QAA committee must include the DON, medical director or designee, a minimum of three other members of the staff (either the administrator, an owner, a board member, or other leader must be one of the three), and the infection preventionist (the infection control nurse).  The QAA committee oversees the QAPI program and reports to the governing body or its designee.
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38. 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.
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39. 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.
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