Providence Marianwood, DAB CR6731 (2025)

DECISION

Petitioner, Providence Marianwood, challenges the determination by Respondent, the Centers for Medicare & Medicaid Services (CMS), that it was not in substantial compliance with federal requirements regarding infection prevention and control.  The facility also challenges the Directed Plan of Correction (DPOC) imposed as a result.  As explained herein, I find in favor of CMS.

I. Background

Petitioner is a skilled nursing facility located in Issaquah, Washington that participates in the Medicare program.  CMS Ex. 2 at 1.  Surveyors from the Washington Department of Social and Health Services (DSHS or state agency) conducted an unannounced infection control-focused survey and abbreviated complaint investigation at Petitioner’s facility completed on December 11, 2020.  Id.  Based on that survey, DSHS found Petitioner was not in substantial compliance with 42 C.F.R. § 483.80(a)(1), (a)(2), (a)(4), (e), and (f) (Tag F880).  Id.; CMS Ex. 1 at 1.

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DSHS cited the Tag F880 deficiency at scope and severity level1 “E,” meaning a pattern of noncompliance that causes no actual harm but has the potential for more than minimal harm that does not amount to immediate jeopardy to resident health and safety.  CMS Ex. 1 at 1; SOM Ch. 7, § 7400.3.1 at 15.

Based on that deficiency finding, DSHS notified Petitioner on December 14, 2020 it would impose a Directed Plan of Correction (DPOC).  CMS Ex. 2 at 1.  DSHS required Petitioner to undertake remedial measures including training staff on CDC infection control guidelines, performing a root cause analysis to determine the source of Petitioner’s infection control issues, and implementing acceptable standards of practice for infection control.  Id. at 2.

On March 1, 2021, DSHS conducted a post-survey revisit of Petitioner’s facility and determined Petitioner returned to substantial compliance as of February 10, 2021.  CMS Ex. 10.  As a result, DSHS recommended CMS permit Petitioner’s continued participation in the Medicare program and did not recommend the imposition of a civil money penalty (CMP) or other remedies.  Id.

Petitioner timely sought a hearing before an Administrative Law Judge (ALJ) in the Civil Remedies Division to challenge CMS’s determination of noncompliance with program requirements and the Tag F880 citation, resulting in my designation to hear and decide this case.2  P. Req. for Hearing.

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I issued an Acknowledgment and Pre‑hearing Order that established a briefing schedule and directed the parties to file pre-hearing submissions that included written direct testimony for all proposed witnesses, proposed exhibits, and pre-hearing briefs.

CMS filed a motion for summary judgment and pre-hearing brief (CMS Br.) with 10 proposed exhibits (CMS Exs. 1-10).  Petitioner filed a response to CMS’s motion for summary judgment, cross-motion for summary judgment, and pre‑hearing brief (cumulatively, P. Br.) as well as 10 proposed exhibits (P. Exs. 1-10).  CMS identified one witness for whom it provided written direct testimony, state agency surveyor Mercedes Carrion.  CMS Ex. 8.  Petitioner identified and provided written direct testimony for one witness, Kaizerine Blanes-Blendermann, its Assistant Director of Nursing and Infection Preventionist.  P. Ex. 9.

II. Admission of Exhibits and Decision on the Record

A. Admission of Exhibits

Neither party objected to the opposing party’s proposed exhibits.  I therefore admit CMS Exhibits 1 through 10 and Petitioner Exhibits 1 through 10 into the record.

B. Petitioner’s Request to Strike is Denied.

Petitioner requests the document it submitted with its hearing request be removed from DAB E-File because it contains resident names and is potentially disclosable under the Freedom of Information Act (FOIA).  P. Br. at 4 n.2; DAB E-file Dkt. No. C-21-479, Doc. No. 1a.  Petitioner’s concern that a third party could obtain sensitive records from this case after its disposition is overwrought.  FOIA provides a presumptive right of access by the public to agency records but also exempts broad categories of information from disclosure, including “personnel and medical files and similar files the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.”  5 U.S.C. § 552(b)(6); see also 45 C.F.R. §§ 5.1(a), 5.31(f).  It is unlikely the personal information Petitioner now seeks to protect would be disseminated under the auspices of FOIA.

Second, in cases arising in this division, CMS typically provides a key that identifies relevant anonymized residents and members of staff by name to minimize confusion and ensure accurate correlation of the records provided for each resident and the staff members who generate those records.  That CMS failed to do so here does not undercut the fact that resident identities are properly part of the record.  For these reasons, I deny Petitioner’s request.

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C. A decision on the written record is appropriate.

CMS initially sought to cross-examine Petitioner’s sole witness but subsequently filed an unopposed request for me to decide this matter on the written record.  By so doing, CMS withdrew its request to cross-examine and both parties withdrew their respective motions for summary judgment.  CMS’s unopposed motion is granted.  I decide this case based on the record before me.  Civ. Remedies Div. P. § 19(c).

III. Issue

Whether Petitioner was in substantial compliance with 42 C.F.R. § 483.80(a)(1), (2), (4), (e), (f) (Tag F880).

IV. Jurisdiction

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

V. Legal Authority for the Imposition of Penalties

The Social Security Act (Act) sets forth requirements for skilled nursing facilities to participate in the Medicare program.  The Act authorizes the Secretary of Health and Human Services to promulgate regulations implementing those statutory provisions.  42 U.S.C. § 1395i-3.  These regulations are found at 42 C.F.R. parts 483 and 488.

To participate in the Medicare program, skilled nursing facilities must maintain substantial compliance with program participation requirements.  To be in substantial compliance, a facility’s deficiencies may “pose no greater risk to resident health or safety than the potential for causing minimal harm.”  42 C.F.R. § 488.301.  A deficiency is a violation of a participation requirement established by 42 U.S.C. § 1395i-3(b)-(d), or the Secretary’s regulations at 42 C.F.R. pt. 483, subpt. B.  Id.  “Noncompliance” means “any deficiency that causes a facility to not be in substantial compliance.”  Id.

The Secretary contracts with state agencies to conduct periodic surveys to determine whether skilled nursing facilities are in substantial compliance with the participation requirements.  42 U.S.C. § 1395aa(a); 42 U.S.C. § 1395i-3(g); §§ 488.10(a), 488.308.  The Act authorizes state agencies to impose or recommend to the Secretary enforcement remedies to be imposed against skilled nursing facilities not in substantial compliance with program participation requirements.  42 U.S.C. 1396r(h); 42 U.S.C. § 1395i-3(h)(1).  The Secretary can impose enforcement remedies with or without a state agency’s recommendation.  42 U.S.C. § 1395i-3(h)(2).  The Secretary’s regulations specify the enforcement remedies that CMS or a state agency may impose if a facility is not in substantial compliance.  See 42 C.F.R. § 488.406.  Among them, CMS or a state agency

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may impose a directed plan of correction.  42 C.F.R. §§ 488.406(a)(7), 488.424.  A plan of correction “describes the actions the facility will take to correct deficiencies and specifies the date by which those deficiencies will be corrected.”  42 C.F.R. § 488.401.

A skilled nursing facility subject to a remedy based on a determination of noncompliance may request a hearing before an ALJ to determine whether there was a basis for the deficiency findings that led to the imposition of the remedy.  42 U.S.C. §§ 1320a-7a(c)(2), 1395i-3(h)(2)(B)(ii); 42 C.F.R. §§ 488.408(g), 488.434(a)(2)(viii), 498.3(b)(13).  However, the choice of remedies is not subject to review.  42 C.F.R. § 488.408(g)(2).

VI. Burdens of proof and persuasion

In adjudications proceeding under the Administrative Procedures Act (APA), Congress established that “the proponent of a rule or order has the burden of proof[,]” except where otherwise provided by statute.  5 U.S.C. § 556(d).  The Act does not “otherwise provide[]” for allocation of the burden of proof or the quantum of evidence necessary to meet that burden in this type of proceeding.  It would therefore be reasonable to conclude that CMS, the agency that propounded the regulations implementing its enforcement authority under the Act, bears the burden of proof and persuasion to justify imposition of penalties authorized by the Act.

Nevertheless, the Departmental Appeals Board has imposed a burden-shifting regime in cases involving the imposition of enforcement penalties against providers whose appeals are adjudicated under 42 C.F.R. Part 498.  Hillman Rehab. Ctr., DAB No. 1611 (1997), aff’d, Hillman Rehab. Ctr. v. U.S. Dep’t of Health & Human Servs., No. Civ. A. 98-3789 (GEB), 1999 WL 34813783 (D.N.J. May 13, 1999); VITAS Healthcare Corp. of Calif., DAB No. 1782 at 4 (2001); Cross Creek Health Care Ctr., DAB No. 1665 (1998) (applying the burden-shifting regime to cases involving skilled nursing facilities); Batavia Nursing & Convalescent Inn, DAB No. 1911 (2004), aff’d sub nom., Batavia Nursing & Convalescent Ctr. v. Thompson, 143 F. App’x 664 (6th Cir. 2005).

Under that regime, CMS has the burden to come forward with evidence sufficient to make a prima facie showing3 it had a basis to impose a penalty.  In Hillman, an appeal by a rehabilitation center of its termination as a provider to the Medicare program by the Health Care Finance Administration (CMS’s predecessor agency), the Board identified the elements it believed necessary for CMS to make such a showing:

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[CMS] must identify the legal criteria to which it seeks to hold a provider.  Moreover, to the extent that a provider challenges [CMS’s] findings, [CMS] must come forward with evidence of the basis for its determination, including the factual findings on which [CMS] is relying and, if [CMS] has determined that a condition of participation was not met, [CMS’s] evaluation that the deficiencies found meet the regulatory standard for a condition-level deficiency.

DAB No. 1611 at 8.

Once CMS makes a prima facie showing of noncompliance, the Board held the facility bears “the ultimate burden of persuasion” and can only prevail if it proves, by a preponderance of the evidence of record, that it substantially complied with statutory and regulatory requirements.  Id. at 7.

Subsequently, a skilled nursing facility appealing CMS’s imposition of a CMP argued burden-shifting would be improper in hearings proceeding under the APA.  Batavia Nursing & Convalescent Inn, DAB No. 1911 (2004), aff’d sub nom., Batavia Nursing & Convalescent Ctr. v. Thompson, 143 F. App’x 664 (6th Cir. 2005).

The Board rejected this claim, explaining the Supreme Court approved placing the burden of proof “on the claimant for governmental benefits when evidence is evenly balanced” because the party seeking the benefit, including a “non-monetary benefit or privilege,” would, in that context, be “the proponent of the rule or order.”  Batavia Nursing, DAB No. 1911 at 10 (citing Director, OWCP v. Greenwich Collieries, 512 U.S. 267, 276 (1994); U.S. Steel Corp. v. Train, 556 F.2d 822, 834 (7th Cir. 1977) (the applicant for a permit to discharge pollutants is a “proponent”); Day v. NTSB, 414 F.2d 950, 952 (5th Cir. 1969) (finding it appropriate to place the burden of proof on a pilot seeking certification of fitness to fly).

The Board reasoned that by appealing the penalties imposed by CMS, Batavia Nursing in essence sought “from the government an order certifying that it is in substantial compliance with [skilled nursing facility] requirements, so that it may continue to participate in the Medicare program with no restrictions on payment.”  DAB No. 1911 at 10.  The Board therefore concluded it reasonable to place the burden of proof on Batavia to show its return to substantial compliance.  Id.

The legitimacy of the burden-shifting regime thus rests largely on the Board’s characterization of facilities as proponents of a rule or order because they seek a certification of substantial compliance with Medicare program participation rules, even though the jurisdiction of ALJs and the Board to hear such challenges is limited

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exclusively to circumstances where CMS opts to impose a penalty.4  42 C.F.R. § 488.408(g)(1) (“A facility may appeal a certification of noncompliance leading to an enforcement remedy.”); 42 C.F.R. § 498.3(b)(13); Columbus Park Nursing & Rehab. Ctr., DAB No. 2316 at 7 (2010) (a facility cannot contest survey deficiency findings unless CMS has imposed a remedy).

To date, federal district and circuit courts have declined to disturb the Board’s burden-shifting regime on due process or other grounds.  See, e.g., Hillman Rehab. Ctr., DAB No. 1611 (1997), aff’d, Hillman Rehab. Ctr. v. U.S. Dep’t of Health & Human Servs., No. Civ. A. 98-3789 (GEB), 1999 WL 34813783 (D.N.J. May 13, 1999); Fairfax Nursing Home, Inc., DAB No. 1794 (2001), aff’d, Fairfax Nursing Home v. Dep’t of Health & Human Servs., 300 F.3d 835 (7th Cir. 2002), cert. denied, 2003 WL 98478 (Jan. 13, 2003); Batavia Nursing & Convalescent Inn, DAB No. 1911 (2004), aff’d sub nom., Batavia Nursing & Convalescent Ctr. v. Thompson, 143 F. App’x 664 (6th Cir. 2005).

However, the Supreme Court has since examined the scope of the Secretary’s rulemaking authority in the context of Medicare reimbursement and held that under section 1871 of the Act, the Secretary must comply with notice-and-comment rulemaking under the APA to impose any requirements upon regulated entities which constituted a change in a substantive legal standard.  Azar v. Allina Health Servs., 587 U.S. 566, 139 S. Ct. 1804 at 1809-14 (2019).

The Court has also formally repudiated its longstanding interpretive rule, known as Chevron deference, which required courts reviewing agency actions to defer to agencies’ interpretation of their statutory mandate where the language of the statute in question was ambiguous.  See Loper Bright Enters. v. Raimondo, 603 U.S. 369, 144 S. Ct. 2244 (2024); see also Hillman Rehab. Ctr., DAB No. 1611 at 17-20 (justifying burden-shifting in part by noting its consistency with the “long-standing interpretation” of the Act and its implementing regulations by the Board’s predecessor body).

It remains to be seen whether federal courts will consider the Board’s burden-shifting regime a “change in a substantive legal standard” under the Allina holding or, in the absence of Chevron deference, more broadly reject the Board’s interpretation of section 7 of the APA to identify entities challenging enforcement actions taken by the government as proponents of an order or rule.  Until such judicial scrutiny demands otherwise, and

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absent modification of the Act or CMS’s implementing regulations, I apply the Board’s burden-shifting regime.

VII. Discussion

A. Legal framework for Infection Prevention and Control

The Act and its implementing regulation require facilities like Petitioner to “[e]stablish and maintain an infection control program designed to provide a safe, sanitary, and comfortable environment in which residents reside and to help prevent the development and transmission of disease and infection[.]”  42 U.S.C. § 1395i-3(d)(3)(A); 42 C.F.R. § 483.80.  At minimum, a facility’s infection control policy must satisfy the following requirements:

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

(1)  A system for preventing, identifying, reporting, investigating, and controlling infections and communicable diseases for all residents, staff, volunteers, visitors, and other individuals providing services under a contractual arrangement based upon the facility assessment conducted according to § 483.70(e) and following accepted national standards;

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

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

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

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

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

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

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

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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.

                               *        *        *

(e)  Linens.  Personnel must handle, store, process, and transport linens so as to prevent the spread of infection.

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

42 C.F.R. § 483.80(a)(1), (a)(2), (a)(4), (e), (f).

Beyond prescribing the presence of these elements, the regulation does not mandate specific standards and measures but instead grants facilities discretion to develop and implement infection control protocols consistent with “accepted national standards” for infection control.  42 C.F.R. § 483.80(a)(1); Golden Living Ctr. – Superior, DAB No. 2768 at 7-8 (2017).  Upon establishing such policies and protocols, a facility must implement those protocols and assure they are effective.  Id.  A facility is not in substantial compliance with participation requirements when it fails to follow standard precautions and isolation control procedures specified in its own infection control policies.  Heritage House of Marshall Health & Rehab. Ctr., DAB No. 2566 at 12-13 (2014).

B. Petitioner’s infection control policy

Petitioner’s COVID-19 Management Plan in effect at the time of the survey categorized residents assessed for possible COVID-19 infection into four categories:  unlikely cases, unknown cases, suspected or probable cases, or confirmed cases.  CMS Ex. 7 at 2-3.  A resident with a “suspected” case of COVID-19 would be further identified as either a Person Under Investigation or Person Under Monitoring.  Id. at 2.  Petitioner’s policy defined a Person Under Investigation as “a person who screens positive but has no other

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etiology that fully explains the clinical presentation” and a Person Under Monitoring as “a person who has been exposed [to the COVID-19 virus] but is asymptomatic.”  Id.

If a resident developed symptoms consistent with COVID-19, Petitioner’s policy required staff to notify the resident’s provider and a designated “infection leader” who would then contact the local health department, DSHS, and the Home and Community Care infection preventionist.  CMS Ex. 7 at 5.  The facility’s screening procedures included reporting instructions for the four assessment categories.  Id. at 3-4, 8.  These instructions required staff to report probable or suspected cases, which included both Persons Under Investigation and Persons Under Monitoring, to the resident’s primary care provider, the local department of health, the Centers for Disease Control and Prevention, and the HCC infection preventionist hotline.  Id. at 3-4.  Petitioner’s policy required staff to notify the local health department of confirmed or suspected COVID-19 cases every three days and to submit online reports to DSHS for each new Person Under Investigation.  Id. at 8.

C. Relevant Facts

A member of Petitioner’s staff, Staff E, was tested for COVID-19 infection on November 22, 2020 and received a positive result the next day.  CMS Ex. 3 at 1.  Results from facility-wide testing conducted on November 24, 2020 were returned on November 27, 2020 and revealed a positive test result for Residents 10 and 11, both of whom were moved to private rooms for isolation and monitoring.  Id. at 1-2.

On December 1, 2020, Petitioner conducted facility-wide COVID testing using Point of Care (POC) rapid antigen tests for patients and residents.  Id. at 3.  After seven residents – Residents 12 through 18 – received positive POC test results, Petitioner identified them as “presumptive positives” and moved them into quarantine rooms.  Id.  The facility administered PCR tests which were returned December 3 to 4, 2020, and confirmed Residents 12, 13, 14, and 16 to be positive for COVID-19, while Residents 17 and 18 received negative PCR test results.  Id.  That same day, staff member Staff E reported nausea and vomiting during her shift.  Id. at 4.  PCR testing administered on December 1, 2020 returned results on December 3, 2020 confirming her to be positive for COVID-19.  Id.  Staff H similarly received a PCR test on December 1, 2020 which yielded a positive test result on December 4, 2020.  Id. at 5.

On December 3, 2020, Resident 1, whose roommate had earlier tested positive for COVID-19, developed a cough.  Id.  The facility administered a POC test to Resident 1 and placed the resident under COVID-19 precautions to await the results of a PCR test administered at the same time.  Id.  PCR tests results received December 5, 2020 confirmed Resident 1 was positive for COVID-19 infection, at which point Petitioner moved Resident 1 into isolation.  Id.

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Another facility-wide round of testing on December 4, 2020 revealed presumptive positive results for Residents 2, 3, 4, 5, 17, and 18; all six residents received PCR tests that confirmed positive cases of COVID-19.  Id. at 4.  Petitioner received these results on December 6, 7, and 8, 2020.  P. Br. at 7.

On December 9, 2020, Petitioner submitted an incident report online to DSHS.  See CMS Ex. 5.  The facility reported “Patients and Staff tested positive from 12/4/20 scheduled testing.”  Id. at 1.  Petitioner identified Residents 1, 2, 3, 5, 6, 7, 8, 9, 17, 18, and 22 and Staff members B, C, and D as being “affected/involved.”  Id. at 2-5.

D. Petitioner failed to substantially comply with 42 C.F.R. § 483.80(a)(1), (2) because its staff did not follow its own infection control policies.

The regulation requires facilities to establish and maintain an infection prevention and control program designed to provide a safe, sanitary, and comfortable environment and to prevent the development and transmission of communicable diseases and infections.  42 C.F.R. § 483.80.  A facility’s infection prevention and control program must include “[a] system for preventing, identifying, reporting, investigating, and controlling infections and communicable diseases for all residents, staff, volunteers, visitors, and other individuals providing services . . . based upon the facility assessment . . . and . . . accepted national standards.”  42 C.F.R. § 483.80(a)(1).  Once a facility develops policies and protocols, it is required to implement those protocols and assure they are working.  Golden Living Ctr. – Superior, DAB No. 2768 at 7 (2017).

1. Petitioner did not substantially comply with its own policy for reporting suspected COVID cases.

CMS alleges Petitioner was not in substantial compliance with 42 C.F.R. §§ 483.80(a)(1), (2), (4), (e), (f) because the facility failed to accurately and timely report positive COVID-19 test results to DSHS, as its own policy directed.  CMS Br. at 1, 6.5  CMS asserts Petitioner memorialized only five new cases in its COVID-19 Outbreak Investigation Summary on December 4, 2020, but reported 12 new COVID-19 test results for nine residents and three employees on December 9, 2020.  Id. at 6.  Whatever the

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exact number, CMS claims Petitioner violated its own policy by waiting five days to report the presumptively positive cases that arose on December 4, 2020.  Id.

Petitioner responds that 42 C.F.R. § 483.80 does not set forth a reporting timeline.  P. Br. at 5.  The facility otherwise contends that, contrary to CMS’s view, its policy and DSHS required it only to report Persons Under Investigation (PUIs), meaning those with COVID-19 symptoms or those with positive results from positive PCR tests but not POC rapid tests.  Id. at 6.  Petitioner explains that Residents 1 through 5, who were asymptomatic, did not meet the requirement for reporting until they tested positive with a PCR test, meaning December 6, 2020 at the earliest.  Id. at 6-7 (noting “[w]e do not suspect COVID-19 until there are symptoms or a positive [PCR] test.”).  In Petitioner’s view, even with positive POC tests, these residents were not PUIs but Persons Under Monitoring (PUMs), which did not need to be reported until they received confirmed positive PCR test results.  Id.

Petitioner’s arguments are unpersuasive.  First, it is true but irrelevant that 42 C.F.R. § 483.80 does not establish a reporting timeline.  The regulations provide facilities the flexibility to fashion and implement infection control policies and protocols that protect their residents, so long as these systems are consistent with national standards.  42 C.F.R. § 483.80(a)(1); Golden Living Ctr., DAB No. 2768 at 7.  Here, consistent with nationally accepted standards for COVID-19 notification, Petitioner fashioned a policy that assured it would “immediately” report confirmed or suspected COVID-19 cases by submitting reports to the local health department every three days and online reports to DSHS for each PUI.6  CMS Ex. 7 at 8.  Petitioner cannot now evade that obligation because the regulations do not explicitly require it.

Second, Petitioner’s claim it complied with its own policy is plainly incorrect.  Its written COVID-19 Management Plan required it to report suspected cases every three days.  CMS Ex. 7 at 8.  “Suspected [and] Probable Case[s]” included both PUIs (“a person who screens positive but has no other etiology that fully explains the clinical presentation”) and PUMs (“a person who has been exposed but is asymptomatic.”).  CMS Ex. 7 at 2; see also CMS Ex. 7 at 3 (reiterating “probable or suspected” cases include “PUI[s] or PUM[s]” and both triggered the facility’s reporting obligations).

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Concerning the former, Petitioner argues it did not have to identify and report residents who tested positive via POC rapid tests as PUIs because these tests were unreliable7 and not intended to be used for that purpose.  P. Br. at 6.  This claim fails because for reporting purposes, Petitioner’s policy did not distinguish those who tested positive via PCR tests from those who tested positive via POC rapid tests; it simply classified any individual who “screens positive” as a PUI.  CMS Ex. 7 at 2.

Petitioner’s claim is further undermined by its own evidence, namely state agency guidance it proffered concerning the use of POC rapid tests which explicitly advised that “[b]oth Federal and state laws require that all test results, negative and positive, be reported.”).  P. Ex. 5 at 1 (emphasis added).8  DSHS plainly warned Petitioner it would be obligated to report results from POC tests.  Petitioner’s claim to the contrary is without merit. 

Petitioner reported 11 residents as probable or suspected COVID-19 cases to DSHS on December 9, 2020.  CMS Ex. 5 at 2-5.  But its own documentation confirms it obtained positive POC tests results for four residents (Residents 12, 13, 14, and 16) on December 1, 2020, and six residents (Residents 2, 3, 4, 5, 17, and 18) on December 4, 2020.9  CMS Ex. 3 at 3-4.  By waiting five to eight days to report these residents as suspected or probable COVID-19 cases, Petitioner failed to implement its own infection control policy.  Petitioner’s failure to comply with the reporting obligations set forth in its own infection control policy placed its residents at risk of more than minimal harm and constituted noncompliance.  Golden Living Ctr., DAB No. 2768 at 20; Heritage House of Marshall, DAB No. 2566 at 12-13.

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2. Petitioner failed to timely report R1 as a suspected or confirmed COVID case.

Even if I accepted Petitioner’s position that its policy only required reporting of PUIs after a positive “confirmatory” PCR test, Petitioner still failed to comply with its own policy with respect to Resident 1.  The facility’s outbreak investigation summary indicated Resident 1 “developed a cough” on December 3, 2020.  CMS Ex. 3 at 3.  He initially tested negative with a POC rapid test but subsequently received a positive PCR test result on December 5, 2020.  Id.

By Petitioner’s preferred reading of its policy, Resident 1 met the definition of a PUI when he exhibited symptoms of COVID-19 on December 3, 2020 and beyond dispute by December 5, 2020, when he received a positive PCR test result.  See P. Br. at 7 (“We do not suspect COVID-19 until there are symptoms or a positive RT-PCR test.”).  Yet Petitioner failed to report Resident 1’s status to DSHS until December 9, 2020, at best four days after he became a PUI and thus outside the three-day reporting window established by Petitioner’s policy.  Petitioner failed to comply with its own reporting policy with respect to Resident 1.  CMS Ex. 5 at 2.

3. Petitioner failed to report R4 as a suspected or confirmed COVID case

Putting aside whether Petitioner complied with its reporting policy as to other residents, there is no dispute the facility altogether failed to report results for Resident 4.  Petitioner’s records confirm Resident 4 received positive POC and PCR test results during facility-wide testing conducted on December 4, 2020.  CMS Ex. 3 at 3-4.  But the online incident report Petitioner filed with DSHS on December 9, 2020 makes no mention of Resident 4 at all.  CMS Ex. 5.  Petitioner’s failure to report Resident 4’s positive PCR test result supports a separate and independent finding of noncompliance.

VII. Conclusion

For the foregoing reasons, I conclude that Petitioner was not in substantial compliance with 42 C.F.R. § 483.80(a)(1), (2) (Tag F880).