Sagepoint Nursing and Rehabilitation Center, DAB CR6495 (2024)

DECISION

I uphold the findings of the Centers for Medicare & Medicaid Services (CMS) that Sagepoint Nursing and Rehabilitation Center (Petitioner or the facility), a skilled nursing facility (SNF) participating in the Medicare program, was noncompliant with 42 C.F.R. §§ 483.50(a)(1) (Laboratory Services) and 483.80(a)(1)-(2) (Infection Control Program) at the immediate jeopardy level of severity. Further, I conclude that CMS reasonably and appropriately imposed a $15,930 per-day civil money penalty (CMP) on Petitioner for seven days based on these immediate jeopardy-level deficiencies.

I. Legal Framework

The Medicare program “provides basic protection against the costs of . . . related post-hospital . . . care” for individuals over the age of 65 who are eligible for Social Security retirement benefits and for individuals under 65 who meet other criteria. 42 U.S.C. § 1395c. Post-hospital care includes extended care services provided at an SNF. 42 U.S.C. §§ 1395f(a)(2)(B), 1395x(h)-(i).

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For Medicare program purposes, an SNF is an institution that is primarily engaged in providing skilled nursing care and/or rehabilitation services for its residents but is not primarily engaged in the care and treatment of mental diseases. 42 U.S.C. §§ 1395x(j), 1395i-3(a)(1). Because an SNF is a “provider of services” in the Medicare program, each SNF that participates in the program must file a provider agreement with the Secretary of Health and Human Services (Secretary). 42 U.S.C. §§ 1395cc(a), 1395x(u).

In addition to complying with the terms of the Medicare provider agreement, a participating SNF must meet a variety of ongoing statutory requirements regarding how it provides services, maintains the rights of its residents, and administers its facility. 42 U.S.C. § 1395i-3(a)(3), (b)-(d). SNFs also must comply with “such other requirements relating to the health, safety, and well-being of residents or relating to the physical facilities thereof as the Secretary may find necessary.”¹ 42 U.S.C. § 1395i-3(d)(4)(B); see 42 U.S.C. § 1395i-3(c)(1)(xi), (f). The Secretary promulgated regulations to establish those additional requirements.² See 42 C.F.R. pt. 483, subpt. B.

When an SNF fails to meet a statutory or regulatory participation requirement, then the SNF has a “deficiency.” 42 C.F.R. § 488.301; see 42 U.S.C. § 1395i-3(h)(1). “Noncompliance” means “any deficiency that causes a facility to not be in substantial compliance.” 42 C.F.R. § 488.301. To maintain “substantial compliance,” an SNF’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.

Broadly, noncompliance that subjects an SNF to enforcement remedies is divided into two levels. One level comprises deficiencies that immediately jeopardize the health or safety of residents and the other level is composed of deficiencies that do not. 42 U.S.C. § 1395i-3(h)(1). “Immediate jeopardy” exists when “the provider’s noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident.” 42 C.F.R. § 488.301.

The Secretary has the duty to enforce the statutory and regulatory participation requirements for SNFs. 42 U.S.C. § 1395i-3(f)(1). To do so, the Secretary contracts with state agencies to conduct surveys to determine whether SNFs are in substantial compliance. 42 U.S.C. §§ 1395aa(a), 1395i-3(g); 42 C.F.R. § 488.10. Standard surveys are unannounced and occur at least once every 15 months. 42 U.S.C. § 1395i-

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3(g)(2)(A)(i), (iii)(I). State agencies also conduct investigations into complaints against SNFs. 42 U.S.C. § 1395i-3(g)(1)(C), (4). When the results of a survey show that an SNF is not in substantial compliance with Medicare participation requirements, the Secretary may impose enforcement remedies on the SNF. 42 U.S.C. § 1395i-3(h)(2); 42 C.F.R. § 488.406. When CMS selects an enforcement remedy to impose on an SNF, it determines the scope (i.e., the number of residents affected or potentially affected) and severity (i.e., the degree of harm or potential harm) for each deficiency.³ See 42 C.F.R. § 488.404(a)-(b).

One such remedy is a CMP. 42 U.S.C. § 1395i-3(h)(2)(B)(ii). CMS may impose a per‑instance CMP for each instance of the SNF’s noncompliance or a per‑day CMP for the number of days an SNF is not in substantial compliance. 42 U.S.C. § 1395i‑3(h)(2)(A), (h)(2)(B)(ii)(I); 42 C.F.R. § 488.430(a). For CMPs assessed on or after January 17, 2020, and for deficiencies that occurred after November 2, 2015, the CMP amounts may range as follows: $2,233 to $22,320 for per-instance CMPs; $112 to $6,695 per day for less serious noncompliance; or $6,808 to $22,320 per day for more serious noncompliance that poses immediate jeopardy to the health and safety of residents. 45 C.F.R. § 102.3 (2020); 85 Fed. Reg. 2869, 2870, 2880 (Jan. 17, 2020); see also 42 C.F.R. § 488.438(a)(1) (providing original CMP amounts before statutory inflation adjustments).

If CMS imposes a CMP based on a finding of substantial noncompliance, then the SNF may request a hearing before an administrative law judge (ALJ) to challenge CMS’s initial determination of noncompliance that led to the imposition of an enforcement remedy and/or the level of noncompliance (if a successful challenge to the level would affect the range of CMP amounts imposed on the SNF). 42 U.S.C. §§ 1320a-7a(c)(2), 1395i‑3(h)(2)(B)(ii); 42 C.F.R. §§ 488.330(e)(3)(ii), 488.408(g)(1), 488.434(a)(2)(viii), 498.3(b)(13)-(14), (d)(10); see also 5 U.S.C. §§ 554, 556. However, CMS’s choice of remedies is not reviewable. 42 C.F.R. §§ 488.438(e)(2), 488.408(g)(2), 498.3(b)(13).

If an SNF challenges the existence of a deficiency, CMS must make a prima facie case that the SNF failed to substantially comply with federal participation requirements and, if

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CMS makes such a showing, the SNF must then prove substantial compliance by a preponderance of the evidence. Hillman Rehab. Ctr., DAB No. 1611 at 8 (1997); see Batavia Nursing & Convalescent Inn, DAB No. 1911 (2004); Batavia Nursing & Convalescent Ctr., DAB No. 1904 (2004), aff’d, Batavia Nursing & Convalescent Ctr. v. Thompson, 129 F. App’x 181 (6th Cir. 2005); Emerald Oaks, DAB No. 1800 (2001). If an SNF challenges CMS’s determination as to the level of noncompliance, CMS’s determination must be upheld unless it is clearly erroneous. 42 C.F.R. § 498.60(c)(2).

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

Either the SNF or CMS may seek administrative review of an ALJ’s decision. 42 C.F.R. § 498.80.

II. Background and Procedural History

Petitioner is an SNF that participates in the Medicare program and is located in La Plata, Maryland. CMS Ex. 1 at 1.

From April 21, 2020, through May 6, 2020, surveyors from the Maryland Department of Health (state agency or Maryland DOH) conducted a Coronavirus Disease of 2019 (COVID-19 or COVID) Focused Infection Control Survey to investigate three complaints. CMS Ex. 1 at 1; see also P. Ex. 60 at 1-2. The state agency documented several deficiencies in a Statement of Deficiencies (SOD). CMS Ex. 6 at 7-33 (original SOD). The state agency found that two of the deficiencies immediately jeopardized the health and safety of residents at Petitioner’s facility. CMS Ex. 6 at 11-16, 19-32.

Petitioner availed itself of the opportunity to file a plan of correction and request Informal Dispute Resolution (IDR). CMS Ex. 4 at 3-9; CMS Ex. 5 at 3; CMS Ex. 7; CMS Ex. 10. On June 2, 2020, the state agency issued a new SOD at CMS’s direction that added a deficiency and modified the scope and severity (S/S) level of another. CMS Ex. 9. On July 10, 2020, the state agency issued another amended SOD (final SOD) in response to the IDR request, in which it removed one of the deficiencies and modified the text of three deficiencies. CMS Exs. 1, 11, 12. The final SOD alleged the following deficiencies:

• 42 C.F.R. § 483.21(b)(1) (F-Tag 656 (S/S = D) (Development/Implement Comprehensive Care Plan));
• 42 C.F.R. § 483.50(a)(1)(i) (F-Tag 770 (S/S = J) (Laboratory Services));
• 42 C.F.R. § 483.70 (F-Tag 835 (S/S = F) (Administration)); and

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• 42 C.F.R. § 483.80(a)(1), (2), (4), (e), (f) (F-Tag 880 (S/S = L) (Infection Prevention and Control)).

CMS Ex. 1; CMS Ex. 12 at 3-36.

On August 21, 2020, CMS issued a notice of initial determination stating that it was imposing a $15,930 per-day CMP on Petitioner for seven days from April 29, 2020 through May 5, 2020, based on the deficiencies in the final SOD. CMS Ex. 26 at 1-2.

On August 26, 2020, Petitioner requested Independent Informal Dispute Resolution (IIDR). CMS Ex. 14. On October 27, 2020, the IIDR decision upheld all of the deficiencies identified in the final SOD. CMS Ex. 15.

On October 13, 2020, Petitioner filed a request for hearing with the Civil Remedies Division (CRD) to dispute CMS’s initial determination. On October 16, 2020, CRD acknowledged Petitioner’s hearing request and issued my Standing Prehearing Order.

On March 9, 2021, CMS filed a prehearing exchange consisting of a brief and 35 proposed exhibits. Three of the exhibits were written direct testimony from witnesses (CMS Exs. 27-29). On April 19, 2021, Petitioner submitted a prehearing exchange that included a prehearing brief and 81 proposed exhibits. Eight of the exhibits were written direct testimony for witnesses (P. Exs. 71-78). Petitioner also requested to cross-examine all of CMS’s witnesses and objected to some of CMS’s proposed exhibits. On May 4, 2021, CMS filed objections to some of Petitioner’s proposed exhibits and witnesses.

On May 12, 2021, CMS requested to file a late request to cross-examine Petitioner’s witnesses. Petitioner objected to CMS’s request.

On September 7, 2021, Petitioner requested that I issue a subpoena to compel CMS to provide a broad range of documents. On September 10, 2021, CMS submitted CMS Exhibit 36 as a proposed exhibit in the case. On September 16, 2021, CMS objected to Petitioner’s subpoena request, and Petitioner replied to CMS’s objection.

On February 7, 2022, I scheduled a hearing for May 18-20, 2022, to allow the parties to cross-examine the witnesses for whom written direct testimony had been submitted. In the Notice of Hearing, I stated the issues to be decided in this case; granted CMS’s untimely request to cross-examine Petitioner’s witnesses; denied Petitioner’s request for a subpoena as too broad under the regulations; admitted CMS Exhibits 1 through 17, 19 through 29, and 31 through 36, and Petitioner Exhibits 1, 3 through 55, 58 through 76, 77 (only pages 1 through 6), and 78 through 81 into the record. Regarding the exhibits submitted as written direct testimony, I noted that I had only provisionally admitted those exhibits into the record and that they would not be fully admitted into the record until each witness was cross-examined at the hearing or the request to cross-examine the

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witness was withdrawn. While I excluded CMS Exhibit 30 because it was nearly 1,000 pages of many different documents, I permitted CMS to refile each document as an individual exhibit so long as they were not duplicative of any of Petitioner’s exhibits.

On April 25, 2022, Petitioner submitted an additional five proposed exhibits (P. Exs. 82-86). On May 2, 2022, CMS submitted an additional 14 proposed exhibits (CMS Exs. 37-50) composed of documents that had been originally submitted as part of excluded CMS Exhibit 30. CMS did not object to Petitioner’s proposed exhibits; however, Petitioner objected to CMS Exhibits 43, 45, 46, and 48.

In a May 17, 2022 Order, I admitted Petitioner Exhibits 82-86 and CMS Exhibits 37-50. Also on May 17, 2022, CMS filed CMS Exhibit 51, the modified written direct testimony for CMS witness Patricia Tomsko Nay, M.D., that CMS originally submitted as CMS Exhibit 29. Hearing Transcript (Tr.) 5-6.

On May 18 through 20, 2022, I held a hearing in this case. The following witnesses testified at the hearing:

• Andrea Dwyer (P. Ex. 71; Tr. 11-129);⁴
• Patricia Tomsko Nay, M.D. (CMS Exs. 29, 51; Tr. 131-278, 285-317, 537-583);⁵

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• Morgan Katz, M.D. (P. Ex. 76; Tr. 320-419);⁶
• David Charles Grabowski, Ph.D. (P. Ex. 77; Tr. 424-470);⁷
• Bryan W. McEachern, M.D. (P. Ex. 78; Tr. 480-535);⁸

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• Wendy Corbin, R.N. (previously, Wendy Beckley) (CMS Ex. 27; Tr. 600-698);⁹
• Stephanie Yates, R.N. (P. Ex. 75; Tr. 702-718);
• Adam Jenkins, R.N. (CMS Ex. 28; Tr. 722-756); and
• Michele Buscher, R.N. (P. Ex. 72; Tr. 758-869).

At the hearing, Petitioner withdrew Petitioner Exhibits 73 and 74 (i.e., the written direct testimony for witnesses who would not be appearing to be cross-examined); therefore, I excluded those exhibits from the record. Tr. at 4-5.

During the hearing, CMS filed CMS Exhibit 53,¹⁰ and Petitioner objected to it. Tr. 588-592. I reserved ruling on the exhibit. Tr. 595.

Following the production of a transcript of the hearing, the parties had the opportunity to file post-hearing briefs. In a July 1, 2022 Notice of Receipt of Transcript and Post-Hearing Briefing Schedule, I directed the parties to provide all arguments in their post-hearing briefs that they wanted me to consider when rendering my decision. The parties filed post‑hearing briefs (CMS Br., P. Br.) in August 2022, and CMS filed a reply brief (CMS Reply) in September 2022.

When filing its post-hearing brief, Petitioner filed Petitioner Exhibits 87 through 89. On September 2, 2022, CMS objected to the additional proposed exhibits (Sept. 2 CMS Obj.).

On November 16, 2022, Petitioner filed a Motion to File a Supplemental Memorandum along with Petitioner Exhibit 90. On November 30, 2022, CMS filed an objection to Petitioner Exhibit 90 (Nov. 30 CMS Obj.), and also, an opposition to Petitioner’s motion.

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III. Post-Hearing Rulings

A. Evidentiary Rulings

Each party submitted additional proposed exhibits at the hearing or after the hearing to which the opposing party objected. I resolve the objections below.

CMS submitted CMS Exhibit 51 as amended written direct testimony from Dr. Nay. CMS also sought to withdraw CMS Exhibit 29, the original version of the written direct testimony, from the record. Petitioner agreed to the admission of CMS Exhibit 51 if CMS Exhibit 29 would remain in the record. Tr. 132. CMS argued that the witness is allowed to change the written testimony and that the original written testimony (CMS Ex. 29) should not be retained in the record. Tr. 134. I stated at the hearing that Dr. Nay’s amendments to the written testimony involved some substantive matters that Petitioner may wish to explore on cross-examination. Tr. 134-136. Therefore, I did not exclude CMS Exhibit 29. Based on Petitioner’s non-opposition to the admission of CMS Exhibit 51 if CMS Exhibit 29 is retained in the record, I admit CMS Exhibit 51 into the record.

CMS submitted CMS Exhibit 53, a March 30, 2020 Centers for Disease Control and Prevention (CDC) document on the use of Personal Protective Equipment (PPE) when caring for someone with confirmed or suspected COVID-19, in response to Petitioner’s concerns raised at the hearing that CMS’s original version of that document (CMS Exhibit 25 at 3-4) had been issued by CDC on a date after the survey in this case took place (i.e., it does not reflect CDC guidance in effect at the time of the survey). See Tr. 193-206. CMS stated that it had good cause for the late filing of CMS Exhibit 53 because one of CMS’s witnesses, Ms. Corbin, found CMS Exhibit 53 in the survey file. Tr. 588. CMS argued that Petitioner would not be prejudiced by the admission of CMS Exhibit 53 because CMS Exhibit 25 at 3-4 is essentially the same document with the exception of the publication date. Tr. 589.

Petitioner objected to the admission of CMS Exhibit 53 because Ms. Corbin had not referenced CMS Exhibit 53 in either Ms. Corbin’s written direct testimony or her Maryland State hearing testimony to say that “she relied on this document or this sort of document to cite any of the deficiencies or to inform her judgment as to what standard of care was, or what the regulation required, or anything else.” Tr. 590. Therefore, Petitioner argued that the document was not material to the deficiency. Tr. 591.

CMS responded that the SOD does not need to reference all documents relied upon by the surveyors. Tr. 592. Further, CMS submitted CMS Exhibit 53 because Petitioner disputed, at the hearing, that the CDC guidance in CMS Exhibit 25 at 3-4 was in place at the time of the survey. Tr. 593. I reserved ruling to permit Ms. Corbin to testify about the document. Tr. 595.

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Ms. Corbin testified at the hearing that CMS Exhibit 53 “is a document that I received through email from [Maryland DOH], and I printed it off prior to going to the survey at [Petitioner’s facility].” Tr. 604. Ms. Corbin printed the CDC guidance document out “[b]ecause I was reviewing it in anticipation for doing surveys and I was going to [Petitioner’s facility] on the next day to conduct a survey.” Tr. 605.

I overrule Petitioner’s objection and admit CMS Exhibit 53 into the record. Although Petitioner was concerned that the state surveyors did not rely on the document marked as CMS Exhibit 53 during the survey, Ms. Corbin testified that she specifically printed that document out, reviewed it, and took it to the survey at Petitioner’s facility. Further, CMS is not limited to filing exhibits that are mentioned in the SOD. “[T]he SOD’s purpose is not to provide a comprehensive recitation of the evidence supporting the survey agency’s findings. Its purpose is to notify the facility of the nature, scope, and severity of the deficiencies found and the factual basis for the survey agency’s conclusion that regulatory standards had been violated.” Western Care Mgmt. Corp., DAB No. 1921 at 37 (2004). As a result, “[t]he statement of deficiencies does not rigidly frame the scope of evidence to be admitted concerning any allegation relating to a cited deficiency, nor does it require formal amendment to allow additional supporting evidence. The 2567 [i.e., the SOD] is a notice document, and is not designed to lay out every single detail in support of a finding that a violation has been committed.” Northern Montana Care Ctr., DAB No. 1930 at 26 (2004). Therefore, admitting CMS Exhibit 53 is not improper.

Further, Petitioner is not prejudiced by the admission of CMS Exhibit 53 because CMS had timely filed a copy of that document, albeit with a later date printed on it, as CMS Exhibit 25 at 3-4. Petitioner did not object to pages 3 and 4 of CMS Exhibit 25 when that document was submitted. Therefore, Petitioner had sufficient notice of the contents of the document before the hearing.

When filing its post-hearing brief, Petitioner filed Petitioner Exhibits 87 through 89. Petitioner stated that it was submitting Petitioner Exhibit 87, an April 1, 2020 Memorandum issued by Dr. Nay, Executive Director, OHCQ, to nursing homes and assisted living facilities (presumably in Maryland) concerning “COVID-19 Outbreaks” because Dr. Nay identified Petitioner Exhibit 87 at the hearing and “offers it into evidence on that basis now.” P. Br. at 12 n.6. A review of the hearing transcript shows that Petitioner’s counsel read from a document he described as an April 1, 2020 letter sent by Dr. Nay to all nursing homes and assisted living facilities and asked Dr. Nay if she remembered sending that letter. Tr. 579-580. Dr. Nay answered that she remembered that document but, in response to a question about the substance of the document, asked to see a copy of it. Tr. 580. Petitioner’s counsel then stated that “it’s not in this record. It was in the state record, but we will submit it as an exhibit in due course.” Tr. 580-581.

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CMS objected to the admission of this document because the filing of the exhibit was untimely and without a statement of good cause. Sept. 2 CMS Obj. at 1-2.

I sustain CMS’s objection and exclude Petitioner Exhibit 87. Based on Petitioner’s counsel’s statements at the hearing, Petitioner had access to that document during a previous Maryland State ALJ proceeding involving Petitioner and Dr. Nay (see P. Ex. 1), and Petitioner did not submit that document with its prehearing exchange or at the hearing in this case when Dr. Nay requested to see it. Simply having Dr. Nay state at the hearing that she remembered issuing a letter on April 1, 2020, does not mean that Petitioner Exhibit 87 is admissible.

Petitioner stated that it was submitting Petitioner Exhibit 88, a CDC document submitted during the Maryland State ALJ proceeding, to contrast the CDC documents CMS submitted as CMS Exhibit 25. P. Br. at 61 n.41. Petitioner identified a line of questions directed at Dr. Nay at the hearing in this case as being related to the submission of Petitioner Exhibit 88. P. Br. at 61 n.41; Tr. 194-99.

CMS asserted that Petitioner Exhibit 88 is untimely and filed without good cause, is prejudicial to CMS, and is duplicative of CMS Exhibit 50. Sept. 2 CMS Obj.

Similar to Petitioner Exhibit 87, Petitioner admits having had the document since the Maryland State ALJ proceeding and questioning Dr. Nay about a topic related to the document; however, Petitioner waited until after the hearing to submit the document as an exhibit. Further, while the document admitted as CMS Exhibit 50 differs in some minor respects from Petitioner Exhibit 88, they appear to be substantively the same. Therefore, I sustain the objection and exclude Petitioner Exhibit 88.

Petitioner stated that it was submitting Petitioner Exhibit 89, the COVID-19 test result for Resident 4 (R4), because a CMS witness, Surveyor Jenkins, testified at the hearing that he had recently contacted the laboratory that tested the sample from R4 in April 2020 for COVID-19 and learned that the laboratory does not have a record of testing the sample. Petitioner further stated that, in contradiction to Mr. Jenkins’ testimony, Petitioner’s witness, Director of Nursing (DON) Michele Buscher, testified she received a copy of R4’s test result and had a copy present with her at the hearing. Petitioner stated that Petitioner Exhibit 89 was submitted to rebut CMS’s assertion that Ms. Buscher never received R4’s test result. P. Br. at 31 n.17.

CMS asserted that Petitioner Exhibit 89 should not be admitted because Petitioner did not provide this test report during the survey and did not produce it during prehearing exchanges. Sept. 2 CMS Obj. at 1-2. Further, CMS argued it is prejudiced because there is no foundation for the document and, having been submitted after the hearing, no witnesses may be questioned about it. Sept. 2 CMS Obj. at 2.

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Although this document should have been submitted earlier, I overrule the objection. Surveyor Jenkins’ testimony confused the record in this matter as to whether R4 was tested in April 2020, and this exhibit clarifies the record on that point. It is unclear why Surveyor Jenkins called the laboratory shortly before testifying at the hearing in this matter given that he had long ago completed his investigation. Further, DON Buscher testified that she had obtained a copy of the test result from the laboratory, and CMS had the opportunity to conduct a lengthy examination of DON Buscher on that issue. Tr. 815-867. In addition, during the questioning of DON Buscher, Petitioner stipulated that it did not follow up on R4’s missing test result when the test results for the other residents were received. Tr. 862-863, 866. There would be no reason for the DON to falsely testify Petitioner failed to ensure the timely receipt of R4’s laboratory test result. Therefore, I overrule CMS’s objection and admit Petitioner Exhibit 89 into the record.

After post-hearing briefing had been filed, Petitioner filed Petitioner Exhibit 90, which is a Maryland State trial court’s order related to the Maryland State ALJ proceeding mentioned above. As discussed in detail below, Petitioner relied on this order for its collateral estoppel motion filed in this case.

CMS objected to the admission of Petitioner Exhibit 90 because it is untimely, it is prejudicial to CMS, and it is irrelevant because the Maryland administrative proceedings against Petitioner do not affect this case. Nov. 30 CMS Obj.

Unlike Petitioner’s other post-hearing exhibits, Petitioner Exhibit 90 did not exist before the hearing in this case. In addition, the trial court’s order is brief and no witness testimony is required to explain it. While I agree with CMS that the exhibit has almost no relevance to this case, the record in this matter includes the transcript of the Maryland State ALJ hearing (P. Ex. 1), the Maryland State ALJ’s proposed decision (P. Ex. 79), and the Maryland Secretary of Health’s decision reversing the state ALJ’s decision. CMS Ex. 36. Therefore, to ensure the record reflects the final outcome of the Maryland administrative matter, I admit Petitioner Exhibit 90 into the record.

Therefore, the final evidentiary record in this case comprises the following: CMS Exhibits 1-17, 19-29, 31-51, and 53; and Petitioner Exhibits 1, 3-55, 58-72, 75-76, 77 (only pages 1-6), 78-86, and 89-90.

B. Collateral Estoppel

Petitioner requested that I apply collateral estoppel to this case based on the findings of fact in a Maryland State ALJ proceeding. As explained below, I reject Petitioner’s argument as untimely and incorrect.

In a May 8, 2020 letter, Maryland DOH informed Petitioner of deficiencies under both federal and state law and the imposition of CMPs under state regulations. CMS Ex. 6.

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Maryland DOH based the deficiencies on the survey of Petitioner’s facility that took place between April 21, 2020 and May 6, 2020. The letter characterized the survey as an effort to determine if Petitioner’s facility was in compliance with federal and/or state participation requirements for the Medicare and/or Medicaid programs. CMS Ex. 6 at 1. The survey was also conducted for the purpose of state licensure. CMS Ex. 6 at 1.

In the May 8, 2020 letter, Maryland DOH only cited state law as its authority for imposing the CMP on Petitioner. CMS Ex. 6 at 2. Further, Maryland DOH imposed a CMP for immediate jeopardy-level noncompliance from March 30, 2020 through May 6, 2020. CMS Ex. 6 at 2. The May 8, 2020 letter also provided notice, under state law, of an opportunity for a hearing by the Maryland Office of Administrative Hearings to contest the imposition of a CMP. CMS Ex. 6 at 3. Accompanying the May 8, 2020 letter was the SOD that documented the deficiencies under federal law from the April 21, 2020 to May 6, 2020 survey. CMS Ex. 6 at 7-33. However, a second SOD, detailing the deficiencies under state law, was also attached to the May 8, 2020 letter. CMS Ex. 6 at 34-57. The final version of the SOD included an explanation of the deficiencies under federal law. CMS Ex. 12 at 3-36. A separate final SOD indicating the violations under state law was also issued. CMS Ex. 12 at 37-70.

Petitioner appealed Maryland DOH’s actions. P. Ex. 79 at 2. From December 8-11, 2020, a Maryland State ALJ held a hearing in Petitioner’s appeal of the CMP imposed by Maryland DOH. P. Ex. 1. On April 2, 2021, the Maryland State ALJ issued a proposed decision concluding that Petitioner’s facility did not have any deficiencies that posed a serious and immediate risk to any of its residents and that Petitioner should not be subject to the CMP imposed by Maryland DOH. P. Ex. 79 at 48.

On September 9, 2021, the Maryland Secretary of Health, through an individual with delegated authority, issued a final administrative decision reversing the Maryland State ALJ’s proposed decision. The final decision, which is 17 pages long, provided a detailed discussion of the errors in the ALJ’s proposed decision. CMS Ex. 36.

Petitioner sought review of the final decision in a Maryland State trial court. On October 11, 2022, the Maryland State trial judge issued a brief order reversing the final decision and reinstating the state ALJ’s proposed decision. While the order alludes to the trial court providing reasons for this action at the hearing, the order itself does not. P. Ex. 90.

In a filing entitled Petitioner’s Opposition to CMS’ Motion for Leave to File Request to Cross Examine Petitioner’s Witnesses Out of Time, Petitioner alluded to the issue that CMS was collaterally estopped from re-litigating the facts in this case because the Maryland State ALJ already had issued a decision. However, in the Notice of Hearing I issued in this case, I stated that I would not directly address this matter because Petitioner had not filed a formal motion (i.e., Petitioner raised it in an opposition to CMS’s late request to cross-examine witnesses). Notice of Hearing at 4 n.1. I also noted that

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Petitioner’s counsel had made this argument previously in another case filed with CRD and that another ALJ had rejected it. Notice of Hearing at 4 n.1; Life Care Ctr. of Kirkland, DAB CR5975 at 15-26 (2021). Further, I stated that the present proceeding before me was a de novo proceeding and is not affected by decisions made by Maryland officials in administrative proceedings conducted under state law. Notice of Hearing at 9. I decided to admit the transcript (P. Ex. 1) from the Maryland State ALJ proceeding into the record because a number of the witnesses in that proceeding were to appear at my hearing and admission of that exhibit would make cross-examination/impeachment of the witnesses more efficient. Notice of Hearing at 7-8; Tr. 98, 477.

After witness testimony began at the hearing, Petitioner objected to the hearing because the Maryland State ALJ had already held a hearing. Tr. 95-97. As I discuss below, this objection was untimely because the last sentence of the Notice of Hearing provided ten days for Petitioner to object to that notice. Notice of Hearing at 12. Therefore, Petitioner had waived its objection.

At the hearing, I briefly addressed Petitioner’s objection and stated: “I don’t have a legal basis for turning over my fact-finding to a state administrative law judge. The regulations simply don’t say that. . . .” Tr. 98.

As discussed above, after post-hearing briefing was completed in this case, Petitioner submitted the Maryland State trial court’s order reversing the Maryland Secretary of Health’s final decision. P. Ex. 90.

Along with that proposed exhibit (P. Ex. 90), Petitioner filed a Motion to File a Supplemental Memorandum (P. Mot.). In that document, Petitioner argued that the state trial court had repudiated the basis for CMS’s allegations of noncompliance in this case. P. Mot. at 2. As a result, Petitioner questioned whether CMS could “relitigate in this forum” the facts in this case. P. Mot. at 2. Petitioner asserted that federal court case law provides that a litigant, including the government, who has lost a contested factual issue in one forum may not re-litigate the same factual issue in another forum. P. Mot. at 4. Petitioner also cited cases for the proposition that CMS can be bound by the factual findings of the Maryland State ALJ even though not a party to the state proceeding P. Mot. at 5 (“strict adherence to the ‘mutuality of parties’ principle has eroded since at least the 1940’s, and during the interim has been replaced with a functional analysis. . . .”). Petitioner argued that CMS was in privity with the Maryland DOH because Maryland DOH acts as CMS’s “agent” when conducting SNF surveys and CMS uses the results of the survey for the imposition of enforcement remedies. P. Mot. at 5-6 (“CMS plainly stands in the shoes of [Maryland DOH].”).

CMS filed an Opposition to Petitioner’s Motion to File a Supplemental Memorandum (CMS Opp.). CMS argued that the witnesses and exhibits in the Maryland State ALJ case are not exactly the same as in the present proceeding. CMS Opp. at 2-3. CMS also

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pointed out that Petitioner cited no authority for the proposition that a federal ALJ is bound by the decisions of a state ALJ and that the regulations conferring appeal rights on an SNF concerning a CMS-imposed enforcement remedy indicate that the appeal will be before a CRD ALJ. CMS Opp. at 3-4.

As to Petitioner’s argument that CMS was precluded from litigating this case, CMS cited United States v. Mendoza, 464 U.S. 154, 163 (1984) for the proposition “that non-mutual collateral estoppel against the Federal government will not lie.” CMS Opp. at 4. CMS also cited Rockcastle Health & Rehab. Ctr., DAB No. 2891 at 12-13 (2018) as an example where the DAB rejected the idea that collateral estoppel applied to proceedings before a CRD ALJ based on a state administrative proceeding that was conducted first. CMS Opp. at 5.

Further, in response to the motion, CMS compared the Maryland State ALJ’s case to the present one before me. CMS pointed out that the Maryland State ALJ identified different issues to adjudicate than I did. CMS Opp. at 6. Further, the Maryland State ALJ decided legal issues under state law. CMS Opp. at 6. CMS emphasized that collateral estoppel normally only applies to a party to the previous case, and CMS was not a party in the case before the Maryland State ALJ. As a result, the application of estoppel in this matter would preclude CMS from having an opportunity for a full and fair adjudication. CMS Opp. at 6-7.

As an initial matter, I note Petitioner’s failure to timely file a written objection to the Notice of Hearing indicates Petitioner waived this issue. The Notice of Hearing not only provided a deadline for objecting to the notice, but the notice clearly stated that Petitioner had previously failed to properly file a motion concerning this issue. Notice of Hearing at 4 n.1, 12. The ad hoc oral nature of the oral motion after witness testimony began at the hearing shows that Petitioner had not thought to make the motion in a formal and timely manner. Therefore, I deny Petitioner’s motion for untimeliness. However, because Petitioner’s motion is also incorrect, I explain why it should be denied on the merits.

Petitioner failed to provide pinpoint citations to the federal cases Petitioner cited in the motion, making Petitioner’s exact legal authority unclear. P. Mot. at 4-5. Further, none of those cases directly support Petitioner’s position in this case (i.e., that a federal ALJ must apply collateral estoppel against the federal government based on a state administrative proceeding where the federal government was not a party.). Some of the court opinions cited by Petitioner generally involve a party that lost before a state administrative agency and then filed another case in a federal court. The federal courts applied collateral estoppel to dismiss the cases because the individuals had lost analogous cases in a state forum. However, simply because federal courts will dismiss actions brought in federal court when there had been a similar state administrative or court proceeding does not compel federal agencies to adopt a similar rule. Therefore,

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Petitioner provided meager legal authority to show that I am compelled to accept the Maryland State ALJ’s factual findings in this case. To the contrary, federal law requires me to create a record and make findings of fact based on that record.

Under the regulations applicable to this case and the Administrative Procedure Act (APA),¹¹ an ALJ’s fundamental role is to afford the parties a fair opportunity to be heard and to compile an evidentiary record (i.e., provide the parties with the opportunity to present argument, documentary evidence, and witnesses, and to cross-examine adverse witnesses). 5 U.S.C. §§ 554, 556-557; 42 C.F.R. §§ 498.60-498.64. Further, an ALJ must render a decision based on the evidentiary record, which includes findings of fact and conclusions of law. 5 U.S.C. § 557(c) (“All decisions . . . shall include a statement of . . . findings and conclusions, and the reasons or basis therefor, on all the material issues of fact, law, or discretion presented on the record.”); 42 C.F.R. § 498.74(a) (“The decision is based on the evidence of record and contains separate numbered findings of fact and conclusions of law.”).

Further, CRD ALJs conduct de novo proceedings.

Under the de novo review standard, the ALJ addresses whether the evidence as it is developed before the ALJ supports the finding of noncompliance, not how CMS, or the facility, evaluated the evidence as it stood at whatever times CMS or the facility made their assessments. The ALJ hearing thus provides 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); N.C. St. Veterans Nursing Home, Salisbury, DAB No. 2256 at 24 (2009); see also Claiborne-Hughes Health Ctr. v. Sebelius, 609 F.3d 839, 843 (6th Cir. 2010) (recognizing that CRD ALJs apply a de novo review standard).

Petitioner argued that I do not have the authority to make findings of fact (including credibility findings related to witnesses) contrary to those made by the Maryland State

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ALJ. P. Mot. at 9. However, in making this argument, Petitioner cites no provisions of the APA, the Social Security Act, or the Secretary’s regulations that command me not to make findings of fact based on the record in this case. Petitioner cited no case law that requires me to abdicate my fact-finding function in this case. Without such explicit authority, Petitioner’s argument fails.

Further, as CMS asserted, Petitioner’s argument ignores the following case, which upheld an ALJ’s decision to deny summary judgment based on a state ALJ’s decision. It stated, in pertinent part:

Rockcastle moved for summary judgment below, invoking collateral estoppel and res judicata, in reliance on a January 13, 2015 decision of an ALJ of the Commonwealth of Kentucky, Cabinet for Health and Family Services, which found in part that Rockcastle appropriately treated the May 2013 and June 2014 incidents as grievances. Rockcastle asserted that CMS’s enforcement action for violation of section 483.13 requires reference to Kentucky law under which the state cited Rockcastle for allegedly the same deficiencies and that the state ALJ properly determined that Rockcastle exercised discretion to determine whether to investigate and report the complaints as allegations of abuse, precluding the ALJ of the Civil Remedies Division from reviewing that issue. On March 30, 2016, the ALJ who initially presided over the Civil Remedies Division appeal denied the motion.

Rockcastle asserts that the denial of summary judgment was “plainly erroneous as a matter of law” and “materially prejudicial.” RR at 12; id. at 5, 10 (similar argument). This assertion, like Rockcastle’s summary judgment motion, is based on the argument that Rockcastle acted appropriately in treating abuse allegations as grievances. Since we have already upheld the ALJ’s rejection of that argument, we also reject Rockcastle’s assertion of error and prejudice in connection with denying its motion for summary judgment. Moreover, Rockcastle’s assertion disregards settled Board precedent recognizing that federal law, not state law, governs these proceedings.

Rockcastle Health & Rehab. Ctr., DAB No. 2891 at 12-13 (2018) (emphasis added).

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Finally, there are significant differences between the Maryland State ALJ proceeding and this one.

• Petitioner offered two additional witnesses who testified at the hearing in this proceeding but did not at the Maryland State ALJ proceeding, i.e., Michele Buscher, R.N. (P. Ex. 72; Tr. 758-870) and Stephanie Yates, R.N. (P. Ex. 75; Tr. at 702-719).
• CMS did not offer a witness that the Maryland DOH offered at the state ALJ proceeding, i.e., Mark Paugh (P. Ex. 1, Part 1 at 39-119).
• CMS’s exhibits in this case are not exactly the same as Maryland DOH’s exhibits (compare Maryland DOH’s exhibit list attached to CMS Opp. with CMS’s final exhibit list).
• The Maryland State ALJ proceeding included a different allocation of the burden of proof. Ex. 79 at 20 (“The [Maryland DOH] bears the burden of proving the appropriateness of the CMP imposed.”).
• While the Maryland DOH used the findings from the same survey as CMS did to impose CMPs, the specific state law standards applied by the Maryland ALJ are not exactly the same as in the federal regulations. See Ex. 79 at 21-29.
• As the Maryland State ALJ noted, Maryland’s nursing home regulations expressly reference and require adherence to the CDC’s 2007 infection control guidance. Ex. 79 at 27. However, federal regulations only require SNFs to establish an infection prevention and control program using national standards, which means SNFs are not required to adopt CDC guidelines. 42 C.F.R. § 483.80(a)(1); 81 Fed. Reg. 68,688, 68,808 (Oct. 4, 2016) (SNFs were not required to adopt CDC guidelines).¹²
• Maryland DOH imposed a CMP for a longer duration and at a different amount of money than CMS did. CMS Ex. 6 at 2.

Further, Petitioner’s counsel indicated that Petitioner’s brief in the Maryland State ALJ proceeding was nearly 100 pages long but Petitioner’s brief in this case would not be nearly so long. Tr. 477, 873. It turned out to be 68 pages long. See P. Br. Also, during a discussion as to whether the parties would potentially accept the transcript of the cross-

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examination of some witnesses that appeared at the Maryland State ALJ hearing in lieu of cross-examination by the parties at the hearing I was holding, Petitioner’s counsel stated:

Part of the problem, Judge, is that the state transcript is not very good, particularly for the witnesses who were not physically present in the courtroom. Some of the witnesses were and some were not, but we were having all kinds of issues with the loud speakers and the taping system. And so for the witnesses who were not present, which included Dr. Nay, there’s lots and lots of unintelligibles (ph.) and gaps and that sort of thing.

Tr. 478.

Therefore, the record before me is different than that of the Maryland State ALJ proceeding and the Maryland State ALJ was applying facts relevant to different legal standards. Further, the Maryland State ALJ did not have the benefit of a clear transcript when drafting a decision.

Having reviewed the extensive discussion rejecting the same argument raised by Petitioner’s counsel in Life Care Ctr. of Kirkland, DAB CR5975 at 15-26, I am persuaded that the reasoning in that decision is sound and applies equally to this case.

Therefore, for all of these reasons, I reject Petitioner’s motion, expressed informally within its Motion to File a Supplemental Memorandum, that I apply collateral estoppel in this case.

IV. Issues

1) Whether Petitioner was in substantial compliance with the Medicare program requirements for SNFs at 42 C.F.R. §§ 483.21(b)(1), 483.50(a)(1)(i), 483.70, and/or 483.80(a)(1), (2).¹³

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2) If Petitioner was not in substantial compliance with 42 C.F.R. §§ 483.50(a)(1)(i), and/or 483.80(a)(1), (2), whether CMS’s determination that those deficiencies immediately jeopardized the health and safety of Petitioner’s residents is clearly erroneous.

3) If Petitioner was not in substantial compliance with Medicare program requirements, whether a $15,930 per-day CMP, for seven days, is appropriate under the statutory and regulatory factors for setting a penalty amount. 42 U.S.C. § 1320a-7a(d) and 42 C.F.R. § 488.438(f).

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

My numbered findings of fact and conclusions of law (FFCL) appear in bold and italics below.

1. COVID-19 was a new virus that first appeared in the People’s Republic of China in December 2019. In the months of January through March 2020, the CDC, CMS, and Maryland DOH notified health care providers of the infectious nature of COVID-19 and the symptoms that individuals may manifest who contract the virus. Specifically, on March 5, 2020, Maryland declared a state of emergency and catastrophic health emergency in an effort to control the spread of COVID-19. On March 20, 2020, Maryland DOH stated that there were confirmed COVID-19 cases in Maryland and provided the following guidance: symptoms for COVID-19 include fever, cough, and shortness of breath; COVID-19 can spread through coughs and sneezes of infected individuals; and older people (over 60) and people with pre-existing medical conditions are at a higher risk for serious illness from COVID-19. On April 5, 2020, the governor of Maryland authorized the Maryland Secretary of Health to issue directives to nursing homes concerning COVID-19 to stem the spread of the disease. This document stated that COVID-19 spreads easily from person to person and may result in death or serious illness. The document also stated that over 60 nursing homes in Maryland had confirmed cases of COVID-19.

The first outbreak of COVID-19 occurred in the People’s Republic of China in December 2019. P. Ex. 3 at 1. On January 17, 2020, CDC issued an update on COVID-19 stating that individuals in the United States should be treated as patients under investigation for COVID-19 if: 1) they have fever and lower respiratory illness (e.g., cough, shortness of breath) and had, in the last 14 days, traveled to Wuhan City, China, or had close contact with an individual under investigation for COVID-19; or 2) they have fever or lower respiratory illness (e.g., cough, shortness of breath) and, in the last 14 days, had close contact with an ill individual confirmed by laboratory testing to have COVID-19. P. Ex. 3 at 2.

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A February 1, 2020 CDC Health Update indicated that sustained person-to-person spread of COVID-19 occurred in China and that symptoms for COVID-19 “overlap with those associated with other viral respiratory tract infections.” P. Ex. 3 at 5-6. CDC suggested that clinicians ask patients if they have fever or symptoms of lower respiratory infection, such as cough or shortness of breath and had travelled to mainland China within the last 14 days, or whether the patient had close contact with a person confirmed with a COVID-19 infection. P. Ex. 3 at 6.

On February 6, 2020, CMS issued a memorandum entitled “Information for Healthcare Facilities Concerning [COVID-19]” in which it encouraged SNFs to monitor information from the CDC and warned that “[b]ecause [COVID-19] infections can rapidly appear and spread, facilities must take steps to prepare, including reviewing their infection control policies and practices to prevent the spread of infection.” P. Ex. 4 at 1. CMS also advised SNFs that CDC recommended “adherence to Standard, Contact, and Airborne Precautions” as well as to “CDC recommendations on standard hand hygiene practices.” P. Ex. 4 at 2.

On March 5, 2020, a state of emergency and catastrophic health emergency was proclaimed in Maryland, and renewed on March 17, 2020, to control and prevent the spread of COVID-19. CMS Ex. 21 at 4.

On March 10, 2020, Maryland DOH issued a document entitled Recommendations for Infection Control & Prevention of COVID-19 In Facilities Serving Older Adults that noted that CDC concluded “older adults have higher risks related to the COVID-19 disease. . . .” P. Ex. 6 at 1.

On March 20, 2020, Maryland DOH issued an updated set of COVID-19 Frequently Asked Questions. This document stated: there were confirmed cases of COVID-19 in Maryland; older people (age 60 and above) and those with pre-existing medical conditions “have a higher risk for serious illness from COVID-19;” COVID-19 spreads through coughing and sneezing (i.e., respiratory droplets), close personal contact, and touching an object or surface with the virus on it; and COVID-19 symptoms include fever, coughing, and shortness of breath. P. Ex. 14 at 1-2.

In a March 20, 2020 memorandum, CMS informed state survey agencies that, for a three-week period, they would cease conducting standard surveys at SNFs and only conduct targeted infection control surveys and surveys related to complaints that are triaged at the immediate jeopardy level. CMS expressly did this to “allow health care providers time to implement the most recent infection control guidance from both CMS and [CDC].” P. Ex. 12 at 1-2.

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On March 27, 2020, the CDC issued a Morbidity and Mortality Weekly Report that stated “[o]nce SARS-CoV-2 is introduced in a [SNF], rapid transmission can occur.” ¹⁴ P. Ex. 25 at 1. CDC warned that asymptomatic and presymptomatic SNF residents may contribute to COVID-19 transmission. P. Ex. 25 at 1.

On April 5, 2020, the governor of Maryland issued an executive order authorizing the Maryland Secretary of Health to issue directives “to monitor, treat, prevent, reduce the spread of, and suppress COVID-19 in and around Nursing Homes.” The basis for this executive order was that COVID-19 “spreads easily from person to person and may result in serious illness or death;” COVID-19 had been detected in more than 60 Maryland nursing homes; and nursing home residents “are part of vulnerable populations that may be particularly susceptible to complications and adverse outcomes associated with COVID-19.” CMS Ex. 21 at 4.

2. Residents in SNFs were highly vulnerable to death and severe illness from COVID-19 due to their age and generally weakened health. COVID-19 could spread easily in SNFs because many residents needed to receive personal care from staff and SNFs are designed for communal living.

Although the COVID-19 pandemic presented a dangerous situation for all people, the residents in SNFs were particularly at risk for acquiring and dying from COVID-19. This was especially true at the beginning of the pandemic before rapid COVID-19 testing, vaccines, and treatments became available.

One of Petitioner’s expert witnesses, Professor Grabowski, testified that neither the long-term care system as a whole nor individual facilities were sufficiently resourced to address a sudden widespread outbreak of a new infectious disease. P. Ex. 77 at 3. Professor Grabowski stated that SNFs with obsolete air handling systems and “frail elderly persons in very close proximity to one another, set[] up ideal conditions for contagion.” P. Ex. 77 at 3-4. Further, SNF care involves “caregivers going from resident to resident to reposition, bathe, change and administer medications to multiple residents. My research indicates that the most likely vector of COVID-19 in most facilities has been asymptomatic infected staff who unknowingly spread the disease from resident to resident.” P. Ex. 77 at 4. Professor Grabowski further stated that “even a single infected resident or staff member can spread the virus through a nursing or assisted living facility within days, before anyone knows that anyone is infected.” P. Ex. 77 at 5. Professor Grabowski testified that the “result can be devastating” when COVID-19 spreads “in nursing facilities filled with frail elderly persons.” P. Ex. 77 at 5.

During cross-examination, Professor Grabowski provided an example of an SNF in Massachusetts that experienced a COIVD-19 outbreak in April 2020 resulting in

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numerous deaths and stated that “things can go very quickly from asymptomatic individuals to resident deaths, especially in that period when we didn’t have testing.” Tr. 437. Professor Grabowski further testified that testing for COVID-19 “is an important way to help with containing COVID . . . along with other, you know, cohorting, personal protective equipment, and a series of other steps. . . .” and that testing could help SNFs properly cohort (i.e., keeping COVID-positive and COVID-negative patents or residents separate). Tr. 440.

Dr. McEachern similarly testified that individuals who were infected with COVID-19 might be asymptomatic but could still transmit the disease to others. P. Ex. 78 at 3. Dr. McEachern also testified that COVID-19 was spread almost entirely by infected respiratory droplets, making droplet isolation the most effective means of controlling person-to-person transmission. P. Ex. 78 at 15. Dr. McEachern stated that CDC recommended six feet of physical separation. Further, one method for isolating infected residents in an SNF is to cohort infected residents with one another in designated areas to minimize contact with persons who are not known to be infected. P. Ex. 78 at 15-16.

One of Petitioner’s medical experts, Dr. Katz, testified that “COVID-19 is a highly contagious respiratory virus.” P. Ex. 76 at 4; Tr. 324. COVID-19 is also potentially lethal for anyone who is infected with it, and the elderly are particularly at risk of dying from a COVID-19 infection. Tr. 325. Dr. Katz stated:

We learned that the most likely form of transmission is through respiratory droplets from breathing, coughing and sneezing within about six feet. We also learned that about 40 percent of infected individuals may not develop any symptoms at all, and that this is true in residents of nursing homes as well (and may be even higher in this population). We now know that people can transmit this virus two days before they develop symptoms, and that they can remain contagious for at least ten days after they develop symptoms, and in severe cases, even longer, up to twenty days. We know that there is little evidence that fomite transmission – that is via hard surfaces – is a significant means of transmission, and that the evidence of transmission by airborne particles that remain suspended in the air for long periods may be more important than we initially thought.

P. Ex. 76 at 4 (emphasis added). Dr. Katz took the risk for airborne particles remaining suspended in the air for longer periods quite seriously when she testified that she would recommend “airborne precautions” be taken, rather than droplet precautions, when coming in contact with SNF residents who are COVID-positive. Tr. 410.

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Research prior to the COVID-19 pandemic gave Dr. Katz an understanding that a virus like COVID-19 would pose significant risks to SNFs. P. Ex. 76 at 4. Dr. Katz testified that COVID-19 presented such a risk because: 1) the resident population is highly vulnerable and suffers the worst outcomes from the disease; 2) residents require close personal care from staff; and 3) residents reside in structures meant for group living. Tr. 325-26; see P. Ex. 76 at 4. At the beginning of the COVID-19 pandemic (i.e., March, April, and May 2020), there was a 25% mortality rate among SNF residents infected with COVID-19. Tr. 326-327. Further, a study that Dr. Katz was involved in stated that SNF residents that contract COVID-19 are “at particularly high risk of infection and poor outcomes” and that SNFs “have emerged as ‘hot spots’ for [COVID-19] infection and mortality globally.” P. Ex. 63.

Dr. Katz emphasized that “asymptomatic spread is a significant driving factor for the large outbreaks we have seen in long-term care facilities. If you do not identify these asymptomatic cases, then it is impossible to isolate them, and almost impossible to control the virus in a congregate living setting. . . . In other words, without the ability to identify these asymptomatic cases, effective isolation and resident cohorting to prevent transmission from infected to non-infected persons is almost impossible.” P. Ex. 76 at 6; see also P. Ex. 63 at 2.

Dr. Nay, CMS’s medical expert, testified consistently with Petitioner’s expert witnesses as to the threat that COVID-19 posed to nursing home residents:

COVID-19 is infectious disease caused by the SARS CoV-2 virus. By the start of [Petitioner’s] survey, it was well established by outbreaks in Maryland and in other states that nursing home residents were highly vulnerable to COVID-19 infection and experienced significant morbidity and mortality. In particular, nursing home residents were highly vulnerable because infectious diseases can spread easily in a congregant living setting if proper infection prevention and control measures are not put in place. Additionally, nursing home residents are inherently vulnerable to higher morbidity and mortality from infectious diseases because they tend to be frail and elderly and tend to have other chronic illnesses and co-morbidities.

CMS Ex. 51 ¶ 18.

The testimony of the witnesses concerning the ability of COVID-19 to spread in nursing homes and its particular danger to aged and infirmed residents is consistent with documentary evidence in the record. As early as March 27, 2020, the CDC voiced concerns that asymptomatic COVID-positive residents in SNFs might help cause the

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spread of COVID-19 and that “[o]lder adults are susceptible to severe [COVID-19] outcomes as a consequence of their age and, in some cases, underlying health conditions.” P. Ex. 25 at 1. An April 24, 2020 New England Journal of Medicine article corroborated CDC’s concern that COVID-19 could be spread by asymptomatic COVID-positive residents. P. Ex. 26 at 2.

Therefore, the record is clear that COVID-19 was a highly transmittable and deadly virus, that was made more so in SNFs due to the congregant setting, the close personal care provided to residents, and the age and infirmity of residents.

Laboratory Test Results Deficiency

3. Petitioner first learned that one of its residents was COVID-positive on March 30, 2020. Petitioner arranged for most of its residents to be tested for COVID-19 using two different laboratories, one of which was Diamond Medical Laboratories. On April 6, 2020, Petitioner collected samples for testing from nearly all of the residents at Petitioner’s facility. The laboratories returned the test results on April 9 or 10, 2020, which showed that approximately 70 residents, or half of the residents in Petitioner’s facility, were COVID-positive. Petitioner moved most COVID-positive residents to designated units to cohort them together.

On March 30, 2020, Petitioner’s staff learned that one of its residents, who was hospitalized at the time, tested positive for COVID-19. P. Ex. 71 at 19; CMS Ex. 10 at 10. Petitioner’s staff began monitoring all residents three times a day for fever and respiratory symptoms. P. Ex. 71 at 20.

On April 2, 2020, Petitioner’s Administrator presented a plan to the county health department for Petitioner to test all facility residents for COVID-19. Because the county could not provide all of the necessary testing resources, Petitioner arranged with a private laboratory, Diamond Medical Laboratories (Diamond Laboratories), “to do the balance” of the tests. P. Ex. 71 at 21. On April 3, 2020, Maryland DOH approved Petitioner’s plan. P. Ex. 51.

Petitioner obtained physician orders to have the tests done and, on April 6, 2020, Petitioner’s staff collected samples from nearly all of the residents in the facility (i.e., approximately 140 residents). P. Ex. 71 at 21; CMS Ex. 10 at 10. Although not required to universally test facility residents (see P. Ex. 24 at 1), Petitioner’s Administrator sought this testing because Petitioner’s staff could not identify asymptomatic residents who had COVID-19. Tr. 28-29.

Petitioner received COVID-19 test results on April 9 and 10, 2020, for all of the residents except R4. Tr. 47-48. These results showed that over 70 residents, or half of the

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residents at the facility, tested COVID-positive. P. Ex. 71 at 22; P. Ex. 72 at 20; see also CMS Ex. 10 at 10. Petitioner relocated most of the COVID-positive or symptomatic residents to the “100” and “200” units at the facility. Some COVID-positive residents remained isolated in single occupancy rooms for a few days after receiving the results. P. Ex. 71 at 22; CMS Ex. 10 at 10.

4. On April 7, 2020, Petitioner’s DON became ill and did not return to the facility until either April 14 or 15, 2020. Petitioner tasked a nurse with infectious disease training to check Diamond Laboratories’ web portal for the COVID-19 test results. The assigned nurse checked the web portal and, as test results were individually received, informed relevant staff. However, facility nursing staff were not responsible for following-up on pending tests for which results had not been received.

In April 2020, Petitioner’s staff needed to access Diamond Laboratories’ web portal to obtain the COVID-19 test results. Diamond Laboratories would add test results to the portal as they came in, instead of uploading all the results together. Tr. 48-49, 54; Tr. 818.

On April 7, 2020, the day after the facility took samples from most of the residents for COVID-19 testing, the DON became ill and did not return to the facility until April 14 or 15, 2020. P. Ex. 72 at 19, 22 (DON testifying to being out through April 14 but also testifying to a return to work on April 14); Tr. 857. The Administrator testified that one individual (a nurse with infectious disease training) at the facility had access to the Diamond Laboratories’ web portal and that person would pass on the test results to the Administrator and other managers. Tr. 48-49, 56. The Administrator also testified that the facility nursing staff did not have responsibility for following up on pending COVID-19 tests. Tr. 57.

5. Although Petitioner’s staff took a sample from R4 for COVID-19 testing on April 6, 2020, and R4 tested positive for COVID-19, either Diamond Laboratories did not add R4’s COVID-positive test result to its web portal on April 9 or 10, 2020, or Petitioner’s staff failed to note the receipt of R4’s test result. In either event, Petitioner’s staff did not realize that R4’s test result was outstanding. On April 20, 2020, R4’s family inquired as to the test result, prompting Petitioner to contact Diamond Laboratories. Petitioner was able to obtain R4’s test result through Diamond Laboratories’ web portal on April 20, 2020. R4 had tested positive for COVID-19.

Petitioner admitted R4 to its facility in 2019. CMS Ex. 34 at 6. R4 was 83 years old during the period relevant to this case. CMS Ex. 34 at 1.

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R4’s diagnoses included chronic pain, mood disorder, osteoarthritis, feeding difficulties, weakness, repeated falls, abnormal posture, depression, anxiety disorder, and dementia with behavioral disturbances. CMS Ex. 34 at 1, 11-12.

On April 6, 2020, the facility collected a sample from R4 for COVID-19 testing. P. Ex. 89 at 1. Diamond Laboratories received R4’s sample on April 7, 2020. P. Ex. 89 at 1.

An April 8, 2020 quarterly assessment indicated that R4: rarely or never understood others or made herself understood to others; did not reject care or wander; did not walk in the corridor or on the unit; utilized a wheelchair; and had no shortness of breath, fever, or respiratory-related diagnoses. CMS Ex. 34 at 7, 8, 9, 12, 30.

Diamond Laboratories documented that it reported R4’s COVID-positive test result on April 9, 2020. P. Ex. 89 at 1.

Petitioner disputes that Diamond Laboratories timely provided the result of R4’s test but admits that its staff failed to realize that it did not receive the test result. CMS Ex. 10 at 11 (Petitioner’s Administrator stated in the IDR request that “[i]t is true that the lab did not deliver [R4’s] lab results in a timely basis, and that given the press of responses to the other positive tests, [Petitioner] did not note that single failure by the lab to do so for several days.”); P. Ex. 71 at 28-29 (Petitioner’s Administrator testified that “[w]e tested Resident # 4 for COVID-19 on April 6, 2020, and . . . it is true that we did not obtain her test result until April 20, ten days after we received most of the other COVID-19 test results.”); Tr. 20, 815-16. Petitioner did not provide supporting documentation that Diamond Laboratories did not timely post R4’s test result to its web portal. Tr. 21, 23.

Whether Diamond Laboratories failed to provide the test result and Petitioner did not follow up to learn that result or Diamond Laboratories properly posted the test result on its web portal and Petitioner missed that report, the fact remains that Petitioner did not know that R4 tested positive for COVID-19 until April 20, 2020. P. Ex. 71 at 30 (Petitioner’s Administrator testified that, “[f]or reasons that have never been clarified, Diamond Lab somehow failed to post Resident # 4’s test result on its web portal, and I concede that my staff missed that omission and did not follow up until the Resident’s daughter raised a question on April 20, 2020.”);¹⁵ Tr. 20, 25-26 (Petitioner’s stipulation that its staff missed the fact R4’s test result was not received for 10 days); see also Tr. 819.

In briefing, Petitioner stated that it stipulated the laboratory did not post the result of the April 6, 2020 COVID-19 test for R4 until April 20, 2020. P. Br. at 29. However,

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Petitioner’s stipulation at the hearing was broader than that and included an admission that Petitioner made a mistake related to learning R4’s test results:

• “We stipulated a long time ago that there was a mistake, that Resident 4 was not caught. The reason, obviously, is because it was not – she was not on the line listing for that purpose. . . . If Resident 4 was not on the line listing, as CMS counsel is suggesting in her questions, well, that may provide the explanation of why she was missed, so I mean, we stipulate that she was missed.” 862-863.
• “Judge, all I can say is to repeat that we have stipulated and we will continue to stipulate that Resident 4 was missed. We don’t know exactly why. We didn’t know then, we don’t know now, and we could put on every nurse in the place to speculate about it, and we still wouldn’t know how or why, but the fact is, we stipulate that Resident 4 somehow was missed.” Tr. 866.

The DON called Diamond Laboratories on April 20, 2020, which resulted in the DON being able to obtain R4’s test result on the web portal. Tr. 819-20. The DON testified that R4’s test result did not appear on Diamond Laboratories’ web portal until April 20, 2020, after the DON called Diamond Laboratories. Tr. 818-19. The DON testified that Diamond Laboratories did not explain why R4’s test result was not in the web portal when all of the other test results were there.¹⁶ Tr. 820.

6. Based on R4’s COVID-positive test result, R4 was infectious and able to spread COVID-19 from April 6, 2020 to April 16, 2020.

According to Petitioner’s expert witness, Dr. Katz, asymptomatic COVID-positive individuals are infectious for ten days from the date of testing. Therefore, Dr. Katz

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opined that R4 ceased to be infectious by April 16, 2020. Tr. 354-355; see also P. Ex. 27 (an asymptomatic COVID-positive individual should be isolated for ten days following positive test result).

7. In early April 2020, Maryland DOH required all nursing homes in Maryland to submit a line listing each day identifying all residents infected with, or suspected to be infected with, COVID-19. The line listing was to be completed on a form that Maryland DOH created. Petitioner’s staff allegedly used the line listing form as a method of tracking COVID-19 test results. However, the line listing did not include a place for a nursing home to document whether it received all COVID-19 test results. Further, Petitioner did not submit copies of the line listings that were allegedly used to track the receipt of the results for the April 6, 2020 COVID-19 test samples. Finally, Petitioner’s line listings did not originally include all of the residents, and Petitioner’s DON had to revise and correct the line listings when she returned to the facility on April 14-15, 2020. Even after the DON took over the line listings, the line listings were prone to inaccuracies as evidenced by the April 16, 2020 line listing that showed R4 had a positive COVID-19 test result when, on April 16, 2020, Petitioner was unaware of R4’s positive test result.

The final SOD alleged the following concerning the 42 C.F.R. § 483.50(a)(1) deficiency:

[T]he facility failed to ensure an effective process was implemented to ensure critical lab results were received timely, resulting in a more than 10 day delay in obtaining COVID testing results for Resident # 4 who was COVID positive. The system failure increased the risk for the spread of the potentially fatal infectious agent from unidentified positive residents to all other residents in the highly vulnerable nursing home population, as well as to staff and visitors.

CMS Ex. 1 at 5-6; CMS Ex. 12 at 7-8.

The final SOD also alleged that Petitioner’s Administrator “acknowledged there was no master list or other process developed to track and ensure that results from all the critical COVID lab tests sent to the lab were reported back to the nursing home timely.” CMS Ex. 1 at 7; CMS Ex. 12 at 9. The Administrator denied telling surveyors that Petitioner’s facility did not have a “master list” or other system to track lab results. P. Ex. 71 at 29; Tr. 37-40. Surveyor Corbin testified that the Administrator had confirmed to the surveyors “that there was no tracking system,” but did not recall that the Administrator said that there was no master list concerning COVID-19 test results. Tr. 677-678; 680-681. For purposes of this decision, I do not base my findings on the Administrator’s

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alleged admission that Petitioner had no “master list” concerning COVID-19 test results. The term “master list” does not appear in the regulations applicable to this case. Rather, I base my findings as to Petitioner’s lack of a method for tracking the receipt of laboratory test results, to ensure timely results are received, on the evidence described below.

The Administrator and DON testified that Petitioner used the Maryland DOH “line listing” form to track the COVID-19 test results. P. Ex. 71 at 30; Tr. 816-17. The Administrator described this as follows:

A. No, ma’am. There was a master list. There were two master lists. The exact same master list that we had turned in every single day to the local department of health and the Maryland Department of Health, the same master list that I turned in every single day to the CDC with Dr. Fedder and the Maryland Department of Health. We had two. It was the state required Maryland Department of Health form. . . .

* * * * *

Q. So is it - - just correct me if I’m wrong, it sounds like your testimony is that you had a master list prior to the survey, but in fact, just so that we’re clear, you’re actually talking about the line listing, correct?

A. Yes, ma’am, a line listing, and we had a bed board....

* * * * *

Q. [C]an you clarify whether that - - the list that you were using, this line listing, contained any information to track when the COVID test results came in?

A. No, ma’am. That’s why [Surveyor] Jenkins didn’t like it. There’s no requirement for that in any state or federal regulation. It was his opinion that it should have that. It obviously had not been the opinion of Maryland Department of Health who both made and regulated the form to use.

Tr. at 39-41.

The DON also testified to using the line listing to track pending test results. Tr. 845. However, the DON was out from work due to illness from April 7, 2020 through April

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14-15, 2020, and someone else allegedly completed the line listings in the DON’s absence. Tr. 857.

The DON testified that, starting with the COVID-19 outbreak at the facility and ending with termination of the outbreak, Petitioner had to submit a line listing to the Maryland DOH each day with certain information about its COVID-positive and COVID-suspect residents. Tr. 821, 845. The line listing was only supposed to include residents who were COVID-positive or with COVID symptoms; however, soon after the DON returned to work on April 14-15, 2020, the DON added the names of all of the residents to the line listing because they all had been tested for COVID-19. Tr. 847-849.

After returning to the facility, the DON took over responsibility for the line listings. Tr. 833. During the hearing, the DON’s recollection was refreshed by reviewing the April 16, 2020 line listing, and she confirmed that R4 was mistakenly listed as being COVID-19 positive when the facility did not yet know the results of the COVID testing for R4. Tr. 823-833.

Although the Administrator and DON asserted that Petitioner used the line listing form as its method of tracking the receipt of COVID-19 test results, Petitioner did not submit any of the line listings from the relevant period (i.e., April 6 through April 20, 2020) to support this contention. Instead, Petitioner submitted, as an example, one redacted line listing, which may be for April 6 or 7, 2020. P. Ex. 53; CMS Ex. 10 at 123-132. Therefore, Petitioner did not provide evidence of the method by which it allegedly tracked COVID test results each day of the critical period.

Given that Petitioner asserts that the daily line listings were used to track COVID-19 test results, it is significant that Petitioner did not submit copies of all the relevant line listings as exhibits in this case. The surveyors requested line listings for January, February, and March, 2020; however, the surveyors noted that those documents were not received. CMS Ex. 17 at 14. It does appear that the surveyors obtained one line listing from Petitioner, probably for April 23, 2020, which is outside the period critical for this deficiency. CMS Ex. 17 at 14; CMS Ex. 19 at 37-55.

Assuming that Petitioner completed line listings earlier in April 2020, besides the one it offered as P. Ex. 53, those line listings did not constitute an effective system to track COVID test results. CMS’s expert witness, Dr. Nay, testified as follows as to why she believed that Petitioner’s method of tracking COVID test results was ineffective:

What was ineffective about the system is that you order lab tests so that you can get information to help guide and inform the care of the resident. You act on those results. You find out they have something, they don’t have something, it’s

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normal or abnormal, and it may require intervention. So you order tests for a reason.

So this was a lab test to see if somebody had COVID-19. So their system was [a]s test results came in, they had a variety of things they did as they came in and notifications, but they didn’t know that there were still test results pending. So it could have been one test result pending or multiple test results pending, but they did not know that they did not have that result yet.

Tr. 263-264. Dr. Nay further testified that Petitioner did not inform the surveyors of “any method they had for knowing what test results were still outstanding for COVID-19 tests.” Tr. 266. Dr. Nay stated:

They track results that came in. They could not produce or explain what they did to know what tests were still pending, and that’s specifically what the deficiency is. So once the results came in, they were acting on results. The deficiency is very specific that they did not know what tests were still pending that they did not have results for.

Tr. at 266. In reply to the question as to whether the deficiency was based on the facility not having a master list of all laboratory tests, Dr. Nay responded:

The basis for this deficiency is that the facility did not produce evidence of a system or a method or a list or any procedure in which they could identify pending lab tests.

* * * * *

[I]t’s not that they didn’t have a system for tracking for results, they had places where they were writing if people were positive or negative. What they lacked was to know who had a result pending. So here are, let’s say they did ten tests. Here are the nine people and their results, but they weren’t aware that number 10’s result never came in. So it’s not that they didn’t track results, it’s that they weren’t aware of what was pending.

* * * * *

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What they didn’t provide was just the part of the system that the pending results, how they knew they were still pending. They did have documents that they produced where they had lists of who was positive and who was negative. And they had information in other places. But they were unable to tell us if in fact there were still people, you know, in regards specifically to number 4, that they did not know that number 4’s test had not come back on April 8th, 9th, or 11th when the other results came in. And it wasn’t until the family on April 20th asked for the results that they checked, and in fact, they hadn’t gotten the results.

Tr. 267-269 (emphasis added).

During cross-examination, Dr. Nay was asked to look at Petitioner Exhibit 53 (i.e., the redacted April 6 or 7, 2020 line listing). Dr. Nay had reviewed that exhibit but did not believe that this was evidence of a system in which the facility would know whether there were outstanding tests for which results had not been received. See Tr. 275-78.

Surveyor Jenkins voiced a similar concern (i.e., that there was no evidence of a system to track the receipt of test results) on cross-examination.

Q. Is it your testimony now that you just really don’t know how the facility was or was not tracking these COVID tests?

A. I have not seen evidence of the actual process that they were using at that time.”

Tr. at 744. Surveyor Jenkins explained his conclusion further:

It was determined that . . . Resident Number 4’s lab test result had not returned to the facility until the 20th, meaning that the facility had an outstanding COVID test and the facility showed us the line listing and was asked, is there any other document that can show a pending test result for results that were being processed in a novel manner, i.e., not being ordered in a traditional electronic format, and the facility didn’t show us any process – any document, or tool, or process that had a list of pending results at that time.

Tr. 749. In addition, Surveyor Jenkins pointed out that Petitioner’s line listings during the relevant time frame did not include all residents who were tested and those for whom

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results were received; therefore, “they weren’t able to use that to track the results and the specimens that were being collected and tested.”¹⁷ Tr. 755.

Based on the record, I find that Petitioner’s alleged use of the line listing to track the receipt of test results was ad hoc at best and, at worst, does not evidence any system to track receipt of COVID test results. The line listing was a form created by the Maryland DOH so that SNFs could report information on COVID-positive and COVID-suspected residents to Maryland DOH. There is no evidence that the line listings were intended to be used by SNFs to track the receipt of COVID test results.

Further, the DON was out of the facility for half of the critical time period in question (i.e., April 7, 2020 to April 14-15, 2020) and was unable to testify she had direct personal knowledge, other than phone communications, that staff was using the line listing to confirm receipt of the COVID-19 test results on April 9 and 10, 2020. Tr. 857-865. The DON testified that she did not know if or when staff added the names of all residents to the line listings while she was out of the facility. Tr. 861-862. The redacted line listing that Petitioner submitted with its IDR request and as an exhibit in this case supports the DON’s concern that she did not know if staff added the names of all the residents to the line listing forms. This line listing appears to be from April 6 or 7, 2020, and only includes the names of approximately 45 residents out of the 144 residents in the facility. CMS Ex. 10 at 123-132; P Ex. 53. This testimony and the only line listing submitted by Petitioner for the relevant time frame call into question whether Petitioner was using the line listings to track the receipt of test results, including pending test results, and, if it was, whether the line listings were properly maintained to serve that purpose.

The Administrator’s testimony tried to downplay the importance of missing R4’s test result because it only “slipped through the cracks.” P. Ex. 71 at 31. The “cracks” were quite large given that Petitioner had no effective system to track the receipt of the test results.

8. Because R4’s COVID-19 positive test result was not received by Petitioner until April 20, 2020, Petitioner did not transfer R4 to a COVID-positive unit and allowed R4 to remain in a COVID-19 negative unit. Petitioner asserted that, despite not transferring R4 to the COVID-positive unit, Petitioner fully isolated R4 in a room in a COVID-negative unit. However, Petitioner cited no documentary evidence in the record of this. Only Petitioner’s Administrator was able corroborate this by testimony. Even so, there was no sign posted on R4’s room that R4 was in isolation and Petitioner cited no documentary evidence in the record to prove that staff always used full PPE in caring for R4 as it would

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for residents in the COVID-positive unit. On April 23, 2020, the surveyors observed R4 being fed by staff in a common room of the COVID-negative unit at the same time as R5 and learned from the facility staff member feeding R4 that R4 and R5 often were fed in the common room. Therefore, there is insufficient evidence in the record to find that R4 had been fully isolated in R4’s room while R4 was infectious from April 6 to 16, 2020.

Petitioner asserted that, while the test results for R4 were not timely received, it does not matter because R4 was isolated in a single occupancy room during the period of time that R4 was contagious. P. Br. at 31, 40.

The Administrator and DON testified that R4 was asymptomatic and was isolated in a single occupancy room with a private bathroom from April 6, 2020 through April 20, 2020. P. Ex. 71 at 31; P. Ex. 72 at 24-25; Tr. 60-63; see also CMS Ex. 10 at 11. However, the Administrator later testified that R4 “was in a semi-private room alone,” but was moved to a private room on April 20, 2020.¹⁸ Tr. 66-67. Further, the Administrator testified that R4 was bedbound, had limited interaction with staff, and none with other residents, except when she was fed in a common room with another resident (i.e., R5) after April 20, 2020. P. Ex. 71 at 31-32, 40; Tr. 126-27.

Because Petitioner had not received the COVID test result for R4, R4 was not officially in isolation and was living in a COVID-negative unit. The Administrator could not testify that R4’s room had an isolation sign displayed on the door but stated that “our staff knew who was COVID positive and who was COVID negative.” Tr. 66; 68-69. However, because Petitioner had not yet received the COVID test result for R4, staff would have incorrectly “known” that R4 was COVID-negative, a misperception reinforced by the lack of a sign indicating R4 was in isolation.

Petitioner’s expert witness, Dr. Katz, reviewed “all the exhibits included in this case.” Tr. 323. Notably, when asked if “you also had no evidence in the record . . . that [Petitioner] put resident 4 on isolation precautions at any time prior to April 20th,” Dr. Katz answered in the affirmative. Tr. 392. Dr. Katz also testified that effective isolation requires conspicuous signage that the individual is in isolation.¹⁹ Tr. 362; see also P. Ex.

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12 at 7 (“Where the patient/resident is sleeping at the health care facility, signage on the patient’s room is important to ensuring that all staff are aware of the necessary infection control steps.”). Finally, Dr. Katz testified that she understood R4 to have been in a single occupancy room but agreed that Petitioner did not make a deliberate decision to isolate R4 for infection control purposes. Tr. 349, 351-352. I agree with Dr. Katz that the record does not show R4 was in isolation during the time when R4 was infectious.²⁰ Therefore, I find that R4 was not fully in isolation because of a lack of documentary evidence supporting Petitioner’s assertion that R4 was treated as fully isolated as well as a lack of signage on R4’s door warning staff and others that R4 was isolated.

It is true that the DON testified that, from April 5, 2020, “every single staff member wore full PPE to care for every single resident. The residents were kept in their rooms. They weren’t allowed to mingle. Their doors were shut while we were waiting for the results of their test.” Tr. 868. However, I cannot credit this testimony because the DON was not present, due to illness, in the facility to observe staff for herself during most of the period when R4 was infectious because the DON was out with an illness from April 7 to April 14-15, 2020. See W. Tex. LTC Partners, Inc., DAB No. 2652 at 15 (2015). Therefore, there is a lack of evidence in the record showing that staff always used full PPE and instituted the same precautions as required for COVID-19 positive residents when caring for R4 during the period when Petitioner ought to have known of R4’s test results (i.e., April 9, 2020 to April 16, 2020).

In addition, there is evidence that R4 had been eating in a common area in the COVID-negative unit with another resident, which Petitioner has not adequately explained or refuted. Surveyor Corbin testified to observing Geriatric Nursing Assistant (GNA) 18 feeding R4 in the communal dining room on April 23, 2020, at 8:30 a.m. CMS Ex. 27 ¶ 12(D). Surveyor Corbin described the location as a small area within the unit R4 was residing in and not the facility main dining room. Tr. 650. At the same time, a GNA was assisting with feeding R5. Neither R4 nor R5 wore masks; however, the GNAs wore masks. CMS Ex. 27 ¶ 12(D). Surveyor Corbin testified that, on April 23, 2020, the GNA stated that R4 “was frequently eating in the common area and so with that information, it would have occurred prior to the day that I observed it.” Tr. 653. It is not absolutely clear as to when R4 started to “frequently” eat in the common area, but given that R4

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would have still been contagious a week earlier, one would expect it would take at least that long before someone would characterize that as “frequently.”

Petitioner could have cleared this matter up by simply providing written direct testimony from the GNA to refute or explain the statement. Petitioner did not and, as a result, I credit the statement of the GNA to the surveyors that R4 frequently was fed in the common room before April 23, 2024. See Beatrice State Developmental Ctr., DAB No. 2311 at 17, 18 (2010) (pointing out that the facility could have but did not present employee testimony that refuted the statements the surveyors claimed they made); Omni Manor Nursing Home, DAB No. 1920 at 11 (2004) (holding that statements of facility employees to the surveyors may be admitted in an administrative proceeding and may constitute substantial evidence). This provided prima facie evidence indicating that R4 was being fed in a public area of the COVID-negative unit during April 2020, which may likely included the period in which R4 was infectious. Petitioner did not meet its burden to refute or otherwise prove R4 was isolated and being fed at all times in R4’s room from April 9 through 16, 2020.²¹

9. Petitioner was not in substantial compliance with 42 C.F.R. § 483.50(a)(1) because Petitioner failed to obtain timely results for the laboratory services (i.e., COVID-19 test) it ordered on R4’s behalf and because Petitioner had no effective method for ensuring the timely receipt of all COVID-19 test results.

CMS charged that Petitioner failed to substantially comply with the following regulatory requirement concerning Petitioner’s obligation to ensure the timeliness of laboratory services provided to its residents:

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The facility must provide or obtain laboratory services to meet the needs of its residents. The facility is responsible for the quality and timeliness of the services.

42 C.F.R. § 483.50(a)(1).²²

As stated in FFCL 5 above, Petitioner does not dispute that it failed to note that R4’s COVID-19 test result was not received on April 9 or 10, 2020, and that Petitioner only obtained the COVID-19 test result for R4 on April 20, 2020, after R4’s family member inquired about the result. The test showed R4 had a COVID-positive result, and thus was infectious until April 16, 2020. R4 resided in a COVID-negative unit at the facility during that time, rather than being transferred to a COVID-positive unit.

Applying the plain meaning of 42 C.F.R. § 483.50(a)(1), Petitioner was responsible for the timeliness of the COVID-19 laboratory services, which includes obtaining the result of the test. Dr. Katz agreed on cross-examination that COVID-19 testing was pointless if the SNF did not follow up on the results of the test because, without the test results, an SNF cannot implement appropriate infection prevention and control measures to address the particular COVID status of each resident. Tr. 357. As explained in FFCL 2, COVID-19 is a highly contagious disease that is particularly deadly to a vulnerable population that lives in a congregant setting, such as SNFs. Further, believing R4 to be COVID-negative, Petitioner did not know to monitor R4. Therefore, R4’s unknown infection status posed a risk of more than minimal harm to R4 and to other residents. In addition, Petitioner’s lack of a system to ensure timely receipt of laboratory results posed such a risk to all residents in the facility.

There is no doubt that CMS easily made a prima facie case for Petitioner’s noncompliance with 42 C.F.R. § 483.50(a)(1). Therefore, as explained in the Legal Framework section of this decision, the burden shifted to Petitioner to show, by a preponderance of evidence, that it was in substantial compliance. Petitioner failed to meet this burden.

As explained in FFCL 7, there is no evidence in the record to find that Petitioner had an appropriate and effective method of tracking and ensuring timely receipt of COVID-19

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test results. While Petitioner may or may not have complied with the Maryland DOH’s requirements that SNFs send line listings for COVID-positive and COVID-suspected residents each day, those line listing documents were not created for the purpose of tracking the timely receipt of COVID-19 test results. Further, Petitioner presented no plausible evidence showing that the line listings were in fact used for that purpose.

As discussed in FFCL 8, Petitioner cites no documentary evidence from the record that R4 was fully placed in isolation during the entire period when R4 was infectious and residing on the COVID-negative unit. Petitioner did not provide testimony from the GNA who told surveyors that R4 was frequently fed in the common room, or testimony that such feedings were not conducted during R4’s period of being infectious.

While Petitioner did not meet its burden to show substantial compliance, Petitioner presented a myriad of arguments as its defense.

Petitioner first argued that it is impossible for it to be charged with noncompliance concerning the April 6, 2020 COVID-19 testing because Petitioner’s decision to test all facility residents was not required by law. Therefore, Petitioner contends that CMS incorrectly finds fault with the testing because a policy or practice adopted by an SNF that exceeds legal requirements does not create a new legal requirement for the SNF. P. Br. at 30-31. Further, Petitioner argues that R4 was not required to have COVID-19 testing at all because R4 was asymptomatic on April 6, 2020. P. Br. at 33. Petitioner asked, how can Petitioner be on notice that CMS may cite a deficiency related to COVID-19 testing and R4 when Maryland DOH guidance at the time discouraged COVID-19 testing of asymptomatic residents? P. Br. at 39.

Petitioner’s argument is incorrect. Petitioner did not establish a new policy or practice that exceeded a legal requirement and then fail to adhere to that self-imposed policy or practice. Rather, Petitioner decided that, as stated in 42 C.F.R. § 483.50(a)(1), the facility needed to obtain COVID testing “to meet the needs of its residents.” As noted in FFCL 3, Petitioner consulted with the residents’ physicians and obtained orders from them to test almost all of the residents. Once Petitioner believed testing was needed and physicians ordered testing, Petitioner became “responsible for the quality and timeliness of the services.”²³ 42 C.F.R. § 483.50(a)(1); see also 42 C.F.R. § 483.50(a)(2)(i).

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Petitioner next argued that use of the line listings, which Petitioner alleged were mandated by Maryland DOH, was a sufficient method of tracking test results because the line listings had a place for the test results and, when that space was blank, this indicated that the test result had not yet been received. P. Br. at 31-32, 38. Petitioner conceded, however, that “during the extreme stress of the COVID-19 outbreak, the nurse who was monitoring test results simply overlooked this one [i.e., R4] test.” P. Br. at 32. Petitioner also complains that neither CMS nor Maryland DOH “ever prescribed any logistics regarding COVID-19 lab test ‘systems,’” and provided no prior notice that using a line listing to comply with regulatory requirements was a sanctionable offense. P. Br. at 33.

As explained in FFCL 7, the record only shows that the line listings were intended as a document to inform Maryland DOH about COVID-positive and COVID-suspected residents at Maryland nursing homes. There is no evidence that it was designed or intended as a means to track the timely receipt of results of COVID tests. Further, Petitioner’s description as to how one would know a test result was not received requires a staff member to regularly review the line listings for that purpose. However, there is little to no evidence that an individual was tasked specifically with checking the line listing each day to determine which test results were outstanding. As one of Petitioner’s expert witnesses stated: “Without the laboratories accurately reporting these, expeditiously reporting their results, you can have system failures.” Tr. 487. This statement is true, but a facility that is tracking the receipt of test results would be able to try to rectify the situation.

Further, as discussed in FFCL 7, the line listings appear to have been incomplete during most of the time R4 was infectious because the DON had to add additional resident names to them when the DON returned to the facility after being out from April 7 to April 14-15, 2020.

Petitioner next argued that 42 C.F.R. § 483.50(a)(1) is ambiguous and that it failed to provide Petitioner sufficient notice that the scenario presented in this case could constitute a deficiency. Further, Petitioner disputed that the plain language of the regulation was violated in this case. P. Br. at 33. Petitioner also stated that neither CMS nor Maryland DOH provided guidance as to “any mandatory ‘system’ for documenting lab test results from an outside laboratory” when there are potentially several methods of tracking the receipt of results. P. Br. at 34.

The text of the regulation is clear – Petitioner is responsible for obtaining laboratory services for its residents and is responsible for the timeliness of the laboratory services. Although the primary factual predicate for the deficiency is evidenced by Petitioner’s failure to timely obtain R4’s COVID-19 test result, the surveyors’ inquiry into that matter showed that Petitioner did not know that it had not received R4’s test result because Petitioner did not have a basic system to track the receipt of test results. While the regulation does not require a specific type of system that must be used to ensure timely

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laboratory results, an SNF must be able to show how it carries out its responsibility to ensure timely laboratory services have been provided.

Instead, Petitioner was apparently reliant on the laboratory to provide the results in a timely manner. A plain reading of the regulation is sufficient to put SNFs on notice that it is ultimately the SNF’s responsibility, not the laboratory’s, to ensure the timeliness of services; therefore, the SNF must have some manner of prompting itself to contact the laboratory for a test result that was not received. See Agape Rehab. of Rock Hill, DAB No. 2411 at 8-9 (2011); Universal Health Care – King, DAB No. 2383 at 7, 9 (2011) (stating that 42 C.F.R. § 483.50(a)(1) (cited in the decisions as 42 C.F.R. § 483.75(j)(1)) is clear and that the “plain language” of that provision should be applied).

The need to have a basic system in place to track the receipt of the COVID-19 test results is consistent with the testimony of both Petitioner’s expert witness and Administrator. Dr. Katz testified that it is a standard of care for nursing home staff to create and implement a system to obtain and respond timely to COVID-19 lab test results to prevent the transmission of COVID-19. Tr. 382-383. Further, Petitioner’s Administrator stated: “The obligation of the facility is to try to do everything we can to receive those test results.” Tr. at 31. Both of these witnesses clearly understood that Petitioner needed an effective system to track the receipt of the COVID-19 test results. The regulatory requirement at 42 C.F.R. § 483.50(a)(1) simply restates the standard of care already applicable to Petitioner. See Tr. 357 (Dr. Katz testifying it is pointless to do COVID-19 testing if an SNF did not follow-up on the test results).

Petitioner also argued that Petitioner cannot be held responsible when it is the laboratory which did not timely provide the test results. P. Br. at 34. However, a prior administrative appellate decision concluded that the regulation holds SNFs responsible for the actions of both its employees (i.e., a laboratory that is part of the SNF) or its contractor (a laboratory that is not owned by the SNF).

Agape argues that its staff did not fail to follow the immediate notification protocol because staff did not learn of the critical lab result until sometime on July 17 and reported the result to the nurse practitioner that day. Agape’s claim that staff did not learn about the result on July 16 is based here, as it was below, on its contention that the lab did not phone the result to the facility, despite the representation to the contrary in the lab report. . . .

* * * * *

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This ongoing factual dispute is not material to our decision because, as Agape acknowledges, while the ALJ stated that she found CMS’s arguments on this factual dispute “compelling,” she ultimately did not rely on those arguments. The ALJ concluded that she did not need to resolve this factual dispute “because federal regulations hold the facility as responsible for the actions of its contractors as it is for the actions of its employees.” ALJ Decision at 9, citing . . . 42 C.F.R. § 483.75(j)(1). As we discuss next this conclusion is legally correct.

* * * * *

Agape contends that it cannot be found out of compliance based on what it alleges was a failure on the part of laboratory personnel rather than its own staff. “The federal regulations do not and cannot require that facilities be strictly liable for any and all actions of their contractors under any set of circumstances.” Agape is incorrect. Applying the plain language of the regulations, as the ALJ did, is not imposing strict liability on Agape. . . . Section 483.75(j)(1) expressly provides that facilities must either provide or “obtain” laboratory services “to meet the needs of its residents” and that “[t]he facility is responsible for the quality and timeliness of the services.”

There is no dispute that Agape arranged with Meridian Laboratory to provide professional services that Agape deemed necessary for quality, timely care of its residents, including performing PT/INR testing and reporting the results.

* * * * *

Holding Agape responsible for the services provided to its residents by contractors, as well as staff, is consistent . . . with the plain language of section[] . . . 483.75(j)(1). . . .

Agape, DAB No. 2411 at 7-9 (internal citations omitted).

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Finally, Petitioner asserted that the surveyors in this case provided false testimony, engaged in misconduct, and potentially committed perjury concerning an allegation they made in the final SOD, i.e., that Petitioner’s Administrator admitted that Petitioner did not have a master list of laboratory tests or an effective system to track laboratory tests. P. Br. at 35-36. Petitioner also charged that Maryland DOH engaged in “very serious . . . misconduct” all in an effort to substantiate the noncompliance cited under 42 C.F.R. § 483.50(a)(1). P. Br. at 37.

As stated at the outset to FFCL 7, I resolved the question as to whether Petitioner had a system to track the receipt of test results based on the substantive evidence in the record and not based on the alleged admission by Petitioner’s Administrator. This is because the Administrator’s testimony contradicted the final SOD.

I make no finding as to whether anyone has lied or was simply mistaken about this minor matter. As my findings show, Petitioner did not submit documentation proving that it had a method or system to track the receipt of the COVID-19 test results or testimony from the employee or employees who maintained any such system. Therefore, had Petitioner’s Administrator stated to the surveyors that Petitioner did not have a master list of pending test results to track the receipt of test results, that would have been true.

Petitioner’s allegations of surveyor misconduct serve only as a distraction and diversion from the fact that Petitioner submitted no documentary evidence showing that it had an effective system to track the receipt of test results. Petitioner would have been better served by simply proving that it had a system in place to track the receipt of laboratory results. Even submitting the relevant line listings may have helped Petitioner’s cause. As it stands, the facility has no evidentiary support it had a method to track the test results.

Petitioner was not in substantial compliance with 42 C.F.R. § 483.50(a)(1) because it failed in its responsibility to obtain timely laboratory services for R4 and failed to have an effective method of ensuring receipt of timely test results.

10. CMS’s determination that Petitioner’s noncompliance with 42 C.F.R. § 483.50(a)(1) posed immediate jeopardy to resident health and safety is not clearly erroneous.

Immediate jeopardy exists if a facility’s noncompliance has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident. 42 C.F.R. § 488.301. The regulation does not require that a resident actually be harmed. Lakeport Skilled Nursing Ctr., DAB No. 2435 at 8 (2012).

I must uphold CMS’s determination as to the level of a facility’s noncompliance (which includes an immediate jeopardy finding) unless it is “clearly erroneous.” 42 C.F.R. § 498.60(c). The “clearly erroneous” standard imposes on facilities a heavy burden to

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show no immediate jeopardy, and determinations of immediate jeopardy have been sustained where CMS presented evidence “from which ‘[o]ne could reasonably conclude’ that immediate jeopardy exists.” See, e.g., Barbourville Nursing Home, DAB No. 1962 at 11 (2005) (quoting Florence Park Care Ctr., DAB No. 1931 at 27-28 (2004)). In reviewing CMS’s finding, I “must consider whether the totality of the allegations support the Agency’s determination that [the SNF’s] noncompliance ‘has caused, or [was] likely to cause, serious injury, harm, impairment, or death to a resident.’” Rosewood Care Ctr. of Swansea, 868 F.3d 605, 618 (7th Cir. 2017) (emphasis omitted).

Petitioner denied that there was any likelihood of serious injury, harm, or death based on the facts involving the 42 C.F.R. § 483.50(a)(1) deficiency. Petitioner argued that there is no possible harm from Petitioner’s failure to obtain R4’s test result. R4 was asymptomatic and did not require treatment. Further, R4 resided in a room alone from April 6, 2020 to April 20, 2020. Petitioner also argued that the surveyors did not observe any breaches of the use of full PPE by staff when at the facility. Petitioner cited one of its expert witnesses, Dr. McEachern, that the missing test result, when considered with the foregoing facts, was clinically irrelevant. P. Br. at 40. Finally, Petitioner argued that, even if R4’s COVID-positive test result was received on April 10, 2020, the facility would have left R4 alone in R4’s room, and there would have been no difference from when R4’s test result was not known in how R4 was treated. P. Br. at 39-41. Petitioner also asserted that its expert witness, Dr. Katz, did not think the deficiency made any sense from a public health perspective as it was based on a “single test [that] slipped through the cracks.” P. Br. at 38.

CMS disagreed with Petitioner’s position that the immediate jeopardy determination was clearly erroneous. CMS argues that immediate jeopardy is supported because the fact that Petitioner did not timely receive the COVID-positive test result posed a threat to R4 and the other residents in the facility. Concerning R4’s health risk, CMS noted that, on cross-examination, Dr. Katz agreed that asymptomatic COVID-positive nursing home residents can decompensate quickly and die within an hour. CMS Br. at 36 (citing Tr. 327-329). CMS also argued that Petitioner’s position ignores a larger problem.

[Petitioner] did not rely upon the system they were supposedly using – the line listings, to follow up on Resident 4’s test, and they were fortunate it was just the one resident whose test was not returned timely. Petitioner also states Resident 4’s care would have been virtually the same even if [Petitioner] received her positive result with the other residents on April 10. Resident 4’s care would have been dramatically different – she would have been cohorted in the COVID-positive unit much earlier, removing the risk of her transmitting COVID-19 to residents who were uninfected. Petitioner’s noncompliance allowed Resident 4 to remain on a

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unit with COVID-negative residents where she ate lunch regularly with an uninfected resident and was at risk of an abrupt deterioration in condition herself, all likely to cause serious harm to Resident 4 or others.

CMS Reply at 5 (citation omitted). CMS also argued:

Additionally, there is no evidence [Petitioner’s] staff, in fact, “isolated” Resident 4. The evidence shows only that Resident 4 happened to reside by herself. The record is devoid of evidence demonstrating that staff deliberately placed Resident 4 in a single room because of her COVID-19 status. Indeed, staff were not even aware Resident 4’s COVID-19 status from April 6, 2020, through at least April 20, 2020. Additionally, there is no evidence staff implemented “isolation” precautions to ensure this resident did not transmit this highly contagious disease to other staff and residents. Indeed, as described above, Resident 4 was observed to be dining in a communal dining area and reportedly doing so on a daily basis.

CMS Br. at 36-37 (citations omitted).

I agree with CMS that Petitioner understates the threat to R4 and other residents that Petitioner’s conduct posed.

Under Petitioner’s COVID-19 infection control program, had Petitioner timely obtained R4’s positive test results, Petitioner would have been obligated to institute “immediate infection prevention and control measures. . . .” CMS Ex. 19 at 27; P. Ex. 47 at 2. These control measures included placing a resident with known or suspected COVID-19 on contact and droplet precautions and attempting “to have the same staff care for the resident and minimize movement throughout facility.” CMS Ex. 19 at 27; P. Ex. 47 at 2. Further, Petitioner’s COVID-19 infection control program required Petitioner to assess and evaluate R4 for a minimum of 14 days “for potential change in condition or additional signs and symptoms. . . .” CMS Ex. 19 at 27; P. Ex. 47 at 2. However, because Petitioner treated R4 as COVID-negative, and Petitioner submitted few documentary records, there is little evidence to conclude that Petitioner instituted all of these required control measures for R4.

Petitioner relied on its expert witnesses to support its position. In written direct testimony, Dr. Katz stated she did not know how Petitioner was non-compliant regarding R4 because R4 was isolated in a single-occupancy room. P. Ex. 76 at 9-10. However, Dr. Katz’s testimony is based on the assumption that R4 was isolated during the entire

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period that R4 was infectious, an assumption that Dr. Katz’s review of the record did not substantiate. Tr. 323, 392. Further, Dr. Katz testified that effective isolation required signage on R4’s door that R4 was isolated (Tr. 362); however, there was no signage on R4’s door. In addition, Dr. Katz agreed that while R4 was alone in R4’s room, Petitioner did not deliberately isolate R4. Tr. 349, 351-352. As explained in FFCL 8, there is an insufficient evidentiary basis that R4 was fully isolated, as Dr. Katz assumed. Dr. McEachern similarly testified based on an assumption that R4 was isolated in a single-occupancy room in conformance with CDC guidelines, which was sufficient to prevent the spread of COVID-19. P. Ex. 78 at 16-17. Again, I reject that view because the record is not sufficiently clear that R4 was in isolation during the period when R4 was infectious.

Dr. Katz also testified that there was minimal risk that R4 spread COVID-19 in the facility because the COVID-19 cases were so widespread in the facility at the time the test results were received for most of the facility residents. P. Ex. 76 at 9. However, this opinion cannot be correct. Under this view, there would have been no need for Petitioner to have bothered separating COVID-positive residents from COVID-negative residents if half of the residents had tested positive and there was no hope to avoid further transmission of the disease. Dr. Katz’s opinion is inconsistent with the rest of the record and I reject it.

On the contrary, the record is clear that it was imperative to take action to stop any potential spread among the residents as soon as possible. As explained in FFCL 2, Dr. Katz testified that COVID-19 is a deadly and highly contagious disease that is particularly transmittable and lethal for nursing home residents. This is borne out by the fact that, by June 3, 2020, 80 percent of the more than 106,000 COVID-19 deaths in the United States were people 65 years of age and older. P. Ex. 69 at 1. At the time period relevant to this case, there were no vaccines or specialized medicine to treat COVID-19 (P. Ex. 14 at 4); therefore, it was imperative to stop COVID-19 from spreading by all available means.

Petitioner’s failure to timely obtain R4’s COVID-positive test result caused R4 to remain on a COVID-negative floor while being infectious. While Petitioner wants to avoid responsibility for its failure to account for all COVID-19 test results by arguing that it did not matter, given the contagious and deadly nature of COVID-19 within the SNF setting, that argument cannot support a finding that CMS’s determination of immediate jeopardy was clearly erroneous.

Further, as CMS’s expert witness testified, the situation involving R4 was likely to cause serious harm based on the spread of a potentially fatal pathogen.

In my expert opinion, [Petitioner] failed to comply with the lab services Medicare requirement at F-Tag 770, 42 C.F.R.

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§ 483.50(a)(1). As explained above, the skilled nursing facility did not have an effective system in place to ensure that COVID-19 test results were received and acted upon timely. The interpretation of test results drive informed decisions about the resident’s medical care. An effective system is particularly important in this instance to determine if a resident had a highly transmissible and potentially fatal pathogen - COVID-19 - that is spread by asymptomatic individuals. A positive COVID test would require the immediate isolation of that individual to protect other residents, staff, and visitors. Therefore, [Petitioner’s] failure to implement an effective lab services system was likely to harm the residents because COVID positive residents who were not identified timely could not be appropriately isolated or to limit the spread of a potentially fatal pathogen.

In my expert opinion, [Petitioner’s] failure to establish an effective lab services system to ensure that COVID-19 test results were received and acted upon timely resulted in Immediate Jeopardy to the Sagepoint residents. The whole point of establishing an effective lab services system is to devise a mechanism to ensure facility staff have the ability to obtain the results of the COVID-19 test timely and to ensure that facility staff can ultimately act quickly on that information to manage infected residents and to protect others from infection. Here, because [Petitioner] lacked such an effective lab services system, infected residents that were not appropriately isolated or cohorted were likely to transmit COVID-19 to non-infected residents and staff.

CMS Ex. 51 ¶¶ 56-57.

Petitioner’s entire argument, focused on whether R4 may have in fact been sufficiently isolated to avoid transmitting the disease, ultimately misses the point of the meaning of the cited noncompliance. It is not really about the individual violation as much as it is what that individual violation conveys about the facility.

Petitioner apparently misunderstands both the nature of noncompliance and the survey process for determining whether facilities are operating in compliance with federal requirements. Noncompliance is a status, not an event. See 42 C.F.R. § 488.301 (Noncompliance is the absence of a level of compliance with all requirements such

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that no identified deficiencies present more than the potential for minimal harm.). The existence of noncompliance may be evidenced by the occurrence of a particular event and surrounding circumstances (such as an accident, a fall, an elopement, or, as here, a mishandled grievance) but the event per se is not the noncompliance. The noncompliance consists in what is revealed by that event about the facility’s performance in meeting (or not meeting) specific requirements and how that performance potentially puts residents at risk.

Donelson Place Care & Rehab. Ctr., DAB No. 3046 at 22 (2021). While this quotation concerns noncompliance generally, it is useful because it makes plain that immediate jeopardy also may be premised on the broader threat of harm than merely whether R4 was or was not, by happenstance, sufficiently isolated while unknowingly residing in the COVID-negative unit.

Therefore, based on the record before me, I cannot conclude that CMS’s determination that there was a likelihood of serious injury or harm to residents based on the situation involving R4 was clearly erroneous. As a result, I reject Petitioner’s claim that R4 was not individually placed in immediate jeopardy. Petitioner’s failure to ensure the timely receipt of R4’s COVID-positive test result meant that R4 was not being monitored for adverse effects from COVID-19 by staff because staff thought R4 was COVID-negative. Indeed, for asymptomatic SNF residents like R4, Dr. Katz confirmed that it is possible for such individuals to decompensate and die quickly. Tr. 327, 329.

I also reject Petitioner’s claim that other residents in the facility were not placed in immediate jeopardy. Dr. Katz agreed that, due to the lethality of COVID-19, it was even more important that SNFs effectively implement their ICPs. Tr. 329; Tr. 332 (agreeing that SNFs need to be rigorous in implementing infection control programs). Further, R4 resided on a COVID-negative unit and was treated as a resident that did not have COVID-19. This put others at risk for being infected. Finally, Petitioner’s failure to have a system in place to track the receipt of COVID test results generally placed the residents of the facility at risk for serious harm because the scenario involving R4 could have been replicated among many residents.

Infection Control Program (ICP) Deficiency

The final SOD alleged that Petitioner did not substantially comply with 42 C.F.R. § 483.80(a) because Petitioner failed to establish and maintain an ICP to contain a COVID-19 outbreak. CMS Ex. 12 at 21. Broadly, the final SOD claimed that Petitioner did not:

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1) sufficiently establish doffing stations and ensure staff followed isolation precautions;

2) ensure effective systems to separate COVID negative and COVID positive residents as much as possible during an infectious outbreak;

3) ensure that staff followed accepted standards of practice for hand hygiene during the declared health emergency;

4) ensure that staff utilized personal protective equipment in a manner that met minimum standards and minimized risk for infectious spread; and

5) develop and implement an effective system to both obtain and clinically respond timely to critical laboratory results.

CMS Ex. 1 at 19; CMS Ex. 12 at 21.

My discussion of this deficiency will be narrower than the allegations in the final SOD and will focus on whether Petitioner implemented its ICP/COVID-19 ICP in relation to Resident 1 (R1) and Resident 2 (R2).

I do not consider whether Petitioner failed to establish an appropriate ICP/COVID-19 ICP because, during the hearing, CMS counsel stipulated that CMS was not pursuing that issue. Tr. 612-14. Therefore, my discussion of the 42 C.F.R. § 483.80(a) deficiency is limited to whether Petitioner maintained (i.e., implemented) its ICP and not whether Petitioner failed to establish an ICP.

In addition, I only discuss the allegations in the final SOD under this deficiency that directly support a finding that Petitioner immediately jeopardized the health and safety of residents. The situations involving R1 and R2 are the primary bases for the immediate jeopardy finding involving the 42 C.F.R. § 483.80(a) deficiency. See CMS Ex. 51 ¶¶ 28, 35, 49(A). As discussed below, because I conclude that the incidents involving R1 and R2 show substantial noncompliance at the immediate jeopardy level of severity, I need not go through the many instances alleged in the final SOD that are not at the immediate jeopardy level of severity. The circumstances concerning R1 and R2, along with the already discussed deficiency at 42 C.F.R. § 483.50(a)(1) involving R4, are sufficient to uphold the enforcement remedy imposed in this case.

11. Petitioner established a general ICP in 2018 and a COVID-19 ICP on March 27, 2020.

Before the COVID-19 pandemic, Petitioner established an Infection Control Procedure Manual, effective May 2, 2018, for its staff to follow. This ICP provided instructions for staff on:

• Glove Use: Petitioner’s staff was to wear gloves when it was reasonable to expect that the staff member may have hand contact with blood and other bodily fluids,

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when performing vascular access procedures, and when handling or touching contaminated items or surfaces. Ex. 41 at 8. The 2018 ICP warned that a “[f]ailure to change gloves between resident contacts or after contact with a known contaminated area or item is an infection control hazard.” P. Ex. 41 at 8. Further, it instructs that “[d]isposable (single use) gloves such as surgical or examination gloves will be replaced a[s] soon as practical when contaminated” and “[s]urgical or examination gloves will not be washed or disinfected for reuse.” P. Ex. 41 at 8.

• Gown Use: Petitioner’s staff were to wear gowns to prevent contamination of clothing and protect the skin of staff from blood and body fluid exposures. In addition to protecting staff, “[g]owns will be worn by personnel during the care of residents infected with epidemiologically important microorganisms to reduce the opportunity for transmission of pathogens from residents or items in their environment to other residents or environments.” P. Ex. 41 at 10.
• Standard Precautions: Petitioner’s staff were to follow standard precautions with all patient care, regardless of suspected or confirmed infection status. “Standard Precautions are designed to both protect the Healthcare Provider (HCP) and prevent the HCP from spreading infections among patients. . . .” P. Ex. 41 at 1. The Standard Precautions required hand hygiene in several situations, including before touching a patient, even if gloves will be worn; before exiting the patient’s care area after touching the patient or patient’s immediate environment; and after glove removal. P. Ex. 41 at 1-2. Proper hand hygiene required the use of soap and water when a staff member’s hands were visibly soiled but otherwise, staff could either wash their hands or use an alcohol-based hand rub. P. Ex. 41 at 2. The 2018 ICP also stated that “[m]asks and protective eyewear or face shields should be worn during procedures that are likely to generate droplets of blood or other body fluids to prevent exposure of mucous membranes of the mouth, nose, and eyes.” P. Ex. 41 at 2.
• Transmission-Based Precautions: Petitioner’s staff were to use Transmission-Based Precautions when Standard Precautions were insufficient to prevent exposure to a resident’s uncontrolled secretions, excretions, bodily fluids, or environmental exposure. “Transmission-Based Precautions includes Contact, Droplet (large disease particles spread through air), and Airborne (small disease particles spread through air).” P. Ex. 41 at 4. The procedures for staff to follow include:
  • Placing the infected resident in a private room or in a room with another resident with the same infection. P. Ex. 41 at 4-5;
  • Wearing gloves when entering the room of the resident, removing the gloves before leaving the resident’s room, and washing hands immediately

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with an antimicrobial agent, and ensuring “hands do not touch potentially contaminated environmental surfaces or items in the resident’s room to avoid transfer of the microorganisms to other residents or environments.” Ex. 41 at 5;

• Wearing a gown when entering the resident’s room and removing the gown before leaving the resident’s room, and ensuring that clothing did not contact potentially contaminated environmental surfaces to avoid transfer of microorganisms to other residents. P. Ex. 41 at 5; and
• Wearing a mask upon entry into the resident’s room for residents on Droplet precautions when there will be close contact with infectious residents. P. Ex. 41 at 5.

Due to the COVID-19 pandemic, Petitioner established, effective March 27, 2020, an ICP for handling suspected and confirmed cases of COVID-19. CMS Ex. 19 at 14-19, 26-35; P. Ex. 47. Petitioner’s 2018 ICP would apply unless a specific provision from the COVID-19 ICP directed otherwise. Tr. 774-75.

Petitioner’s COVID-19 ICP stated that Petitioner’s policy was “to minimize exposures to respiratory pathogens and promptly identify residents with Clinical Features and an Epidemiologic Risk for the COVID-19 and to adhere to Federal and State/Local Recommendations. . . .” CMS Ex. 19 at 26.²⁴

Petitioner’s COVID-19 ICP established requirements, including the following:

• “No group activities (internal and external) or communal dining will occur in the facility at this time.” CMS Ex. 19 at 26.
• “A resident with known or suspected COVID-19, immediate infection prevention and control measures will be put into place.” CMS Ex. 19 at 27. For residents with mild symptoms who do not require hospitalization, these measures include the following (CMS Ex. 19 at 27):

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• “Patients with known or suspected COVID-19 should be placed in a single person room with the door closed.”
• A resident with known or suspected COVID-19, should be placed on contact and droplet precautions.
• “Attempt to have the same staff care for the resident and minimize movement throughout facility.”
• The facility can adhere to the infection prevention and control measures in CMS’s March 13, 2020 nursing home guidance for COVID-19.

• “Residents suspected or confirmed with COVID-19 . . . will be assessed and evaluated for a minimum of 14 days for potential change in condition or additional signs and symptoms, or as long as symptoms are present.”
• The following protocols were to be put into effect with an outbreak at the facility (CMS Ex. 19 at 28):
  • “Place residents in private rooms on standard, contact, droplet precautions when and where availability permits”;
  • “Cohort residents identified with same symptoms/COVID-19 confirmation”;
  • “Implement consistent assignment of employees”; and
  • “Only essential staff to enter rooms/wings.”
• PPE includes gloves, isolation gowns, facemasks, N95 respirators, and eye protection. In the case of supply capacity concerns for isolation gowns, facemasks, or N95 respirators, Petitioner’s COVID-19 ICP references CDC documents that are on the subject of strategies for optimizing the use of those PPE items. CMS Ex. 19 at 28-29.
• “Hand Hygiene using Alcohol Based Hand Sanitizer before and after all patient contact, contact with infectious material and before and after removal of PPE, including gloves.” CMS Ex. 19 at 29.
• “Discontinuation of Isolation Precautions will be determined on a case-by-case basis in conjunction with the State and/or Local Health Department.” CMS Ex. 19 at 29.

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12. After Petitioner tested most of the facility’s residents for COVID-19 in early April 2020, and determined that approximately half of the residents were COVID-positive, Petitioner dedicated two units of the facility for COVID-positive residents and two units of the facility for COVID-negative residents. In the initial testing, R2 tested negative and resided in a single-occupancy room on a COVID-negative unit. On April 14, 2020, R2 ran a low fever with temperatures just below 100° F. Petitioner controlled the fever by providing Tylenol to R2. On April 15, 2020, staff noted R2 was coughing, and staff kept R2’s room door open to monitor R2. On April 16, 2020, staff noted again that R2 was coughing, and Petitioner tested R2 for COVID on April 20, 2020. On April 21, 2020, the facility learned that R2 tested COVID-positive. After the positive test, Petitioner hung an isolation sign on R2’s door. Despite continuing to reside on a COVID-negative unit, Petitioner kept R2’s room door open and R2 was unmasked. R2’s room did not have a designated area, near the door to the room, for staff to remove contaminated PPE when leaving the room. Petitioner moved R2 to a COVID-positive unit the next afternoon.

As stated in FFCL 3, Petitioner tested almost all of the residents in the facility in early April 2020 and, on April 9-10, 2020, Petitioner learned that approximately half of the facility’s residents were COVID-positive. As also explained in FFCL 3, Petitioner responded to this information by designating two units of the facility for COVID-positive residents and cohorting the infected residents on those units.

R2 was tested in early April 2020; however, R2 tested COVID-negative. P. Ex. 71 at 39. R2 resided on a COVID-negative unit in a single occupancy room with a private bathroom. See P. Ex. 71 at 39.

The following are the most relevant entries from the portions of R2’s medical documentation in the record and Petitioner’s summary of the medical record from April 3 through May 8, 2020:²⁵

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• R2 was admitted to the facility in 2017 and, at the time of the survey, R2 was an 88-year-old woman. CMS Ex. 33 at 1, 18.
• R2’s diagnoses included: heart failure; type 2 diabetes mellitus; unspecified dementia; and ventricular tachycardia. CMS Ex. 33 at 2.
• On January 30, 2019, R2 was given oxygen continuously that day with the goal of maintaining an oxygen saturation rate above 88%. An entry indicates there was an order for routine oxygen to be provided to R2. CMS Ex. 33 at 15.
• On March 30, 2020, R2 had a chest X-ray that showed the possibility of active nodular lung disease as well as pneumonia in the left lower lobe. CMS Ex. 33 at 11. On March 31, 2020, R2 had another test that resulted in the following impression: “EMPHYSEMATOUS LUNGS WITH DIFFUSE CHRONIC CHANGES.” CMS Ex. 33 at 11. This finding of emphysema did not include any further statement that pneumonia may be present.
• On April 14, 2020, facility staff took R2’s temperature three times and each showed an elevated temperature of either 99.7° or 99.8° F. CMS Ex. 33 at 4. Petitioner’s staff administered Tylenol to R2. CMS Ex. 10 at 138.
• On April 15, 2020 at approximately 6:35 a.m., Petitioner’s staff noted that R2 had a wet cough. Also, Petitioner’s staff observed that R2’s lung sounds were diminished and R2’s blood oxygen saturation was 97% but only with “continuous O2.” Staff kept R2’s room door open to monitor R2. CMS Ex. 10 at 138.
• On April 15, 2020, R2’s chest was X-rayed and compared to the previous examination on March 30, 2020. The impressions from this test were: “NO ACTIVE LUNG OR PLEURAL SPACE DISEASE. CHRONIC APPEARING INTERSTITIAL TYPE CHANGE IS SEEN AT THE LEFT MID TO LOWER LUNG ZONE.” CMS Ex. 33 at 9.
• On April 16, 2020, at approximately 1:10 p.m., Petitioner’s staff collected a sample from R2 to be tested for COVID-19. CMS Ex. 10 at 139.
• On April 16, 2020, at approximately 4:41 p.m., R2 had a “non productive cough” and was on “O2 continuous.” CMS Ex. 10 at 139.

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• On April 18, 2020, at approximately 7:59 a.m., R2 was noted to have had O₂ desaturation down to as low as 85%. On April 20, 2020, at approximately 4:52 a.m., diminished lung sounds were noted for R2. CMS Ex. 10 at 139.
• On April 21, 2020, at approximately 6:12 p.m., Petitioner received a COVID-positive test result for R2. CMS Ex. 10 at 139.
• On April 22, 2020, at approximately 4:24 p.m., Petitioner transferred R2 to a COVID-positive unit in the facility. CMS Ex. 10 at 140; CMS Ex. 33 at 54.
• An April 28, 2020 quarterly assessment indicated that R2 had no shortness of breath, no fever, and no respiratory related diagnoses; however, it noted that R2 had received oxygen in the prior 14 days. CMS Ex. 33 at 19, 21, 23, 24, 26, 54.
• A May 12, 2020 quarterly assessment noted the following for R2: “fever and active COVID coded for window between 5/6 and 5/12 and she remained on the positive 200 unit – Received Oxygen in prior 14 days.” CMS Ex. 33 at 35, 36, 54.

In addition to the medical records, a few witnesses in this case also testified about R2.

Petitioner’s Administrator testified that R2 had been diagnosed with pneumonia in March 2020 and administered antibiotics. P. Ex. 71 at 38. The Administrator noted that, on April 14, 2020, R2 had a low-grade fever, which was below the 100° F threshold for suspicion of COVID-19, and increased congestion without respiratory distress. P. Ex. 71 at 39. The Administrator said that R2’s fever was reduced the next day and that R2 remained in a single-occupancy room with isolation precautions. P. Ex. 71 at 39. Finally, the Administrator stated that a COVID-positive test result for R2 was received in the late afternoon on April 21, 2020, just before the state agency surveyors arrived at the facility, and R2 was moved to a COVID-positive unit the next morning on April 22, 2020. P. Ex. 71 at 39.

I credit some of this testimony from the Administrator; however, some of it is contradicted by the medical documents/summary. The Administrator claimed that R2 was moved to a COVID-positive unit on the morning of April 22, 2020; however, Petitioner’s summary of the medical record showed a late afternoon transfer on April 22, 2020. The Administrator also questioned whether the April 21, 2020 COVID-positive test result may have been a false positive because R2 subsequently tested COVID-negative on April 30, 2020. P. Ex. 71 at 39. I reject this testimony because it is speculative and inconsistent with the record, which noted that R2 was still COVID-positive with symptoms in a May 12, 2020 assessment. CMS Ex. 33 at 54. Further, there is no documentary evidence of an April 30, 2020 test result in the record.

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Surveyors Corbin and Jenkins testified that, on April 21, 2020, R2 was COVID-positive but was allowed to remain on one of the facility’s COVID-negative units. CMS Ex. 27 ¶ 12(C); CMS Ex. 28 ¶ 12(A). Also on April 21, 2020, Surveyor Corbin observed that: a facility staff member was hanging an isolation precaution sign on R2’s door; R2’s door was open; R2 was not wearing a mask; and R2’s room had no station to doff PPE safely before exiting R2’s room. CMS Ex. 27 ¶ 12(A). Surveyor Corbin testified to reviewing R2’s clinical record on April 22, 2020, and that there was no physician order or progress note indicating that R2 had been or should be placed in isolation. CMS Ex. 27 ¶ 10. I accept this testimony because it has not been contradicted by other evidence in the record.

13. Petitioner was noncompliant with42 C.F.R. § 498.80(a) with respect to R2 because Petitioner failed to maintain/implement its COVID-19 ICP and its ICP. Petitioner’s COVID-19 ICP provides that a resident suspected of being infected with COVID-19 must either be isolated in an individual room with the door closed or may be moved to a unit for COVID-positive residents. However, while R2 was in an individual room, Petitioner kept the door to the room open after R2 first manifested symptoms of COVID-19 on April 14-15, 2020 and while the results of a COVID-19 test were pending for several days. Even after a COVID-positive result was received on April 21, 2020, staff kept R2’s door open. Petitioner did not mask R2 to mitigate the risk of transmission of the virus with the door open. In addition, Petitioner did not establish a way for staff to safely remove their PPE upon leaving R2’s room, in violation of Petitioner’s ICP.

The Social Security Act states:

A skilled nursing facility must—

(A) establish and maintain an infection control program designed to provide a safe, sanitary, and comfortable environment in which residents reside and to help prevent the development and transmission of disease and infection.

42 U.S.C. § 1395i-3(d)(3)(A) (emphasis added); see 42 C.F.R. § 483.80. An ICP needs to be comprehensive and follow national standards:

A system for preventing, identifying, reporting, investigating, and controlling infections and communicable diseases for all residents, staff, volunteers, visitors, and other individuals providing services under a contractual arrangement based upon the facility assessment conducted according to [42 C.F.R.] § 483.70(e) and following accepted national standards.

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42 C.F.R. § 483.80(a)(1) (emphasis added). The regulatory requirement to “establish and maintain” an ICP means that an SNF cannot merely adopt an ICP but must implement the precautions prescribed in the ICP. Golden Living Ctr. – Superior, DAB No. 2768 at 7 (2017); Heritage House of Marshall Health & Rehab. Ctr., DAB No. 2566 at 12 (2014).

The decisions in Golden Living and Heritage House are consistent with a long line of quality-of-care cases holding that CMS “may reasonably rely on a facility’s policy relating to the care and treatment of its residents as evidencing the facility’s understanding of what must be done to attain or maintain residents’ highest practicable physical, mental, and psychosocial well-being, as required by [42 C.F.R.] section 483.25.” Green Valley Healthcare & Rehab. Ctr., DAB No. 2947 at 6 (2019) (citing The Laurels at Forest Glenn, DAB No. 2182 at 18 (2008)); North Las Vegas Care Ctr., DAB No. 2946 at 6 (2019); Hanover Hill Health Care Ctr., DAB No. 2507 at 6 (2013) (observing that “the Board has long held that a facility’s own policy may be sufficient evidence . . . of what the facility has determined is needed to meet the quality[-]of[-]care requirements in section 483.25.”). Therefore, a SNF must implement the ICP it has adopted.

In the present case, the parties focused their arguments on various guidance documents issued by the CDC and Maryland DOH, although their citation to those documents was minimal. The parties ignored Petitioner’s ICPs. In this decision, I follow the statute and its implementing regulation and focus on the provisions of the applicable ICPs that Petitioner had in place at the times relevant to the infection control deficiency. As stated above, acceptable national standards are to be used to create the ICP; however, once the ICP is created, the SNF must implement/maintain that ICP.

In briefing, Petitioner disputed that R2’s situation could serve as a basis for the deficiency. Petitioner asserted that R2 lived in a single-occupancy room with a private bathroom and had been diagnosed and treated for pneumonia in March 2020. According to Petitioner, during this time, R2 occasionally had a wet cough but no other COVID-19 symptoms. R2 was COVID-negative based on an April 3, 2020 test. R2 was stable until April 14, 2020, when R2 had a fever (99.5°-99.8° F) just below the recommended threshold for COVID-19 and increased congestion but no respiratory distress. Petitioner tested R4 for COVID-19 on April 20, 2020, and a positive result came on April 21, 2020. “The resident was moved to a COVID-19 positive unit on April 22, but actually never presented with symptoms of the disease.” P. Br. at 52; CMS Ex. 11 at 21. Finally, Petitioner asserted that R2’s room door was left open to monitor R2’s safety and that R2’s bed was more than six feet from the door, resulting in no risk of harm to anyone at the facility. P. Br. at 53; P. Ex. 71 at 39.

CMS’s position in briefing is that R2 developed symptoms of COVID-19 on April 14, 2020, with a fever and then additional symptoms the following day; however, the facility did not initiate isolation precautions until April 21, 2020, following the positive test

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result. CMS Br. at 39-40. Because R2 remained on a COVID-negative unit, CMS asserts that this violated CDC guidance by failing to isolate potentially infectious residents, by not masking R2 when a cough developed, by not establishing a PPE doffing station at the entrance to R2’s room, and by keeping R2’s door open. CMS Br. at 40.

Overall, I find that the record supports CMS’s position that R2 began to manifest COVID-19 symptoms by April 14-15, 2020. See Tr. 288-289. By mid-March, 2020, CDC and Maryland DOH identified symptoms of COVID-19 to include fever, cough, and shortness of breath. CMS Ex. 38 at 1; P. Ex. 14 at 2. In the present case, the record shows that, on April 14, 2020, R2 ran a low fever of 99.5° to 99.8° F from at least noon on that date until 5 or 6 a.m. on April 15, 2020. CMS Ex. 33 at 4.

Significantly, according to Petitioner’s summary of R2’s medical records, Petitioner’s staff administered Tylenol to R2 at 6:58 a.m. on April 14, 2020, after recording a temperature of 99.8° F. The summary indicated that R2’s temperature dropped to 99.2° F. However, a 1:50 p.m. entry on April 14, 2020, showed R2’s temperature was back up again to 99.7° F. By 4:28 p.m., R2’s temperature was up to 99.8° F and Tylenol was administered again. At 6:35 a.m., on April 15, 2020, R2 had a temperature of 99.5° F. CMS Ex. 10 at 138.

I consider R2’s temperature, approaching 100° F, to be sufficient to be considered a symptom for COVID-19. Petitioner’s Administrator stated in testimony that CDC did not consider a temperature of 99.8° as a fever for purposes of determining that someone was COVID-19 symptomatic. P. Ex. 71 at 39; see also P. Ex. 39 at 6. While this is true, Petitioner’s staff intervened and, through medication, lowered R2’s temperature. Therefore, at the very least, Petitioner ought to have been on the alert for other symptoms since R2’s fever may well have exceeded 100° F had Petitioner not administered a temperature lowering medication.

While Petitioner’s position is that R2 did not have COVID-19 symptoms, I question this position because Petitioner decided, on April 16, 2020, to test R2 again for COVID-19. CMS Ex. 10 at 139. Testing R2 means Petitioner suspected R2 had contracted or been exposed to someone with COVID-19. If Petitioner suspected COVID-19, then it needed to implement its COVID-19 ICP with respect to R2.

According to Petitioner’s COVID-19 ICP, the basic rule is:

A resident with known or suspected COVID-19, immediate infection prevention and control measures will be put into place. . . . If symptoms are mild and do not require transfer to the hospital: Patients with known or suspected COVID-19 should be placed in a single person room with the door closed.

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CMS Ex. 19 at 27. However, when there has been a COVID-19 outbreak, as Petitioner’s facility was experiencing in April 2020, the COVID-19 ICP required Petitioner to “[c]ohort residents identified with same symptoms/COVID-19 confirmation,” and “[p]lace residents in private rooms on standard, contact, droplet precautions when and where availability permits.” CMS Ex. 19 at 28.

Given that Petitioner had already instituted cohorting in the facility, there was no reason given in the record why R2 needed to remain in a COVID-negative unit. However, leaving R2 on the COVID-negative unit was permissible under Petitioner’s COVID-19 ICP so long as R2 resided in a room alone, with the door closed, and R2 was under isolation precautions. Despite these clear requirements, there is no evidence in the record that Petitioner took any action to formally isolate R2. In fact, on April 15, 2020, when staff noted R2 had a wet cough, staff also noted that they were leaving R2’s door open for continuous monitoring. CMS Ex. 10 at 138. This was an action directly contrary to Petitioner’s COVID-19 ICP.

One of Petitioner’s defenses in this case is that by placing R2 in a room alone, R2 was isolated. However, as Surveyor Corbin testified, there is more to isolation than that.

Q. All right. So Resident Number 2 was in a single occupancy room with a private bath, correct?

A. That is correct.

Q. Now, isn’t that how the CDC describes isolation in its 2007 guideline?

A. There are additional guidance that states that the resident should be -- in order for them to be in a contact and droplet isolation, that they should have been in a private room with the door shut, and preferably have a private bathroom, and that there should be a trash receptacle inside the resident door for removing PPE prior to leaving the room.

Q. And that’s in the 2007 CDC guideline?

A. No, that was also in the guidance that came out specifically for COVID-19.

Tr. 617. Therefore, I conclude that Petitioner failed to formally isolate R2 after the onset of COVID-19 symptoms. Further, as discussed below, I also conclude this to be true even after Petitioner learned R2 was COVID-positive and allowed her to remain in a COVID-negative unit with her door open.

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In the late afternoon of April 21, 2020, Petitioner learned that R2 was COVID-positive. CMS Ex. 10 at 139. However, despite the COVID-19 ICP requirement to immediately implement infection control measures, the facility did not make the obvious decision to promptly move R2 to a COVID-19 unit. Since the facility chose to leave R2 on a COVID-negative unit until the following day, Petitioner needed to ensure that R2’s door was closed and R2 was isolated in order to implement its COVID-19 ICP. Not only did Petitioner continue to leave R2’s door open, R2 remained unmasked.²⁶

Further, Petitioner’s general ICP required staff upon entering the room of an isolated resident on transmission-based precautions to wear a gown and then remove the gown before leaving the resident’s room, ensuring that clothing did not contact potentially contaminated environmental surfaces to avoid transfer of microorganisms to other residents. P. Ex. 41 at 5. Surveyor Corbin testified that R2’s room had no designated spot for staff to safely remove and dispose of PPE when leaving R2’s room, showing that Petitioner did not implement the ICP. CMS Ex. 27 ¶ 12(A). When asked about the room’s interior, Surveyor Corbin testified that “there was a sink, and in the center of the room, and that there . . . was a trash can positioned under that sink, and there was quite a distance between the sink and the doorway.” Tr. 626. Surveyor Corbin also testified as to why this was inconsistent with isolating R2: “In a contact isolation situation, you are to reduce any contact – any possible contact with anything in the resident room, because of possible contamination. So the CDC’s guidance stated that there should be a trash receptacle near the exit of the resident room.” Tr. 627.

Petitioner’s COVID-19 ICP clearly provides that the resident’s door must be closed in order to properly isolate the resident. Dr. Katz, one of Petitioner’s expert witnesses, testified that CDC also recommends that COVID-positive residents be isolated in single occupancy rooms with the door kept closed. Despite this, Dr. Katz considered it appropriate for nursing staff to balance strict adherence to the CDC guidance with the resident’s situation and needs. P. Ex. 76 at 11. However, Dr. Katz admitted that she did not review the medical records for the residents in this case and did not know if any of them had a medical condition that warranted leaving the door open for monitoring. Tr. 404. Dr. Katz, Dr. McEachern, and the DON also thought that the residents’ beds were more than six feet from the door to the room, thus minimizing their ability to spread COVID-19 to others. P. Ex. 72 at 24; P. Ex. 76 at 11; P. Ex. 78 at 17.

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Concerning the staff’s ability to remove and safely dispose of PPE when leaving R2’s room, Petitioner’s Administrator testified that every resident room had at least one trash bin near the door or in the bathroom. P. Ex. 71 at 33. The DON testified that CDC guidance only required that Petitioner have “containers that are convenient to the site of removal,” which the DON believed was satisfied by having “central ‘doffing stations’ on ‘COVID-19-positive’ units.” P. Ex. 72 at 26. Dr. Katz testified that the CDC only requires that trash bins be accessible for PPE disposal rather than specific doffing stations. P. Ex. 76 at 12.

Dr. Nay, CMS’s expert witness, assessed the evidence concerning R2’s situation on the evening of April 21, 2020, and concluded that Petitioner failed to isolate R2 properly since R2’s room door remained open and there was no “doffing station” for staff to safely remove PPE when leaving R2’s room. CMS Ex. 51 ¶¶ 25-26. Dr. Nay opined that these lapses were particularly dangerous due to the highly vulnerable population in the facility and the highly transmittable nature of COVID-19. CMS Ex. 51 ¶ 28.

I credit Dr. Nay’s testimony. While Dr. Katz offers an opinion to mitigate Petitioner’s failure to immediately and fully implement its COVID-19 ICP by keeping R2’s room door closed, it is clear that Petitioner failed to fully implement its COVID-19 ICP. If R2 required the room door to remain open, then R2 ought to have been moved to a room on a COVID-positive unit to mitigate the potential for COVID-19 transmission. Although Dr. Katz seems to deem the situation safe because R2 was a little farther away from the room door than six feet, I note that Dr. Katz also testified that, in nursing homes, COVID-19 really requires airborne precautions rather than droplet precautions, indicating that COVID-19 can be transmitted more than six feet in distance. Tr. 410; see also P. Ex. 76 at 4. As a result, I do not accept Dr. Katz’s testimony that there was no chance of transmission beyond six feet from R2. Further, as discussed in more detail below, Dr. Nay testified that Petitioner’s failure to properly place an isolation sign on R2’s door meant that staff would enter R2’s room without knowing R2 was contagious. Those individuals could become infected and then transmit it through the facility. The failure to properly isolate R2 for several days while R2 was suspected of being infected with COVID-19 easily meets the standard for risk of more than minimal harm.

Finally, R2 was maskless with an open room door in the COVID-negative unit. Petitioner provided no evidence that it provided for a safe way for staff leaving R2’s room to doff and dispose of the PPE they had been using. The record shows that Petitioner violated both Petitioner’s COVID-19 ICP and ICP. Further, these violations, which occurred in the COVID-negative unit, had the potential for more than minimal harm to residents.

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

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14. On April 17, 2020, R1 resided in a single-occupancy room on one of Petitioner’s COVID-negative units. On April 17, 2020, R1 had a fever (101.6° F and 100.9° F) and low blood oxygen saturation. On April 20, 2020, the facility learned that R1 tested COVID-positive. Petitioner neither immediately relocated R1 after R1 exhibited symptoms of COVID-19 on April 17, 2020, nor after the COVID-positive test result on April 20, 2020. Petitioner allowed R1 to remain in the COVID-negative unit for several more days. Despite placing an isolation sign on R1’s door after receiving the COVID-positive test result, Petitioner’s staff allowed R1’s door to remain open. R1 was also unmasked and Petitioner did not establish the means for staff to safely remove their PPE upon leaving R1’s room.

At the time of the survey, R1 was an 89-year-old woman. CMS Ex. 32 at 1, 35. R1 was admitted to the facility in 2016. CMS Ex. 32 at 1, 35. R1’s diagnoses included the following: non-Alzheimer’s dementia; history of transient ischemic attack and cerebral infarction without residual deficits; atrial fibrillation; peripheral vascular disease; and chronic venous hypertension with ulcer of left lower extremity. CMS Ex. 32 at 2, 40, 52.

Petitioner’s staff made quarterly assessments of R1 on February 4, 2020 and May 4, 2020. On February 4, R1 was assessed to have a BIMS score of 15 but assessed to have a BIMS of 13 on May 4. Both assessments indicated that R1 used a wheelchair, did not walk in the resident’s room or corridor, or wander. The February 4 assessment indicated no shortness of breath, fever, or respiratory symptoms; however, the May 4 assessment stated that R4 had an active COVID-19 diagnosis. CMS Ex. 32 at 35-36, 38, 47-48, 50, 52, 59.

R1 was tested for COVID-19 on April 6, 2020. P. Ex. 59 at 7. On April 10, 2020, R1’s test results indicated R1 was COVID-negative. P. Ex. 59 at 6. At about noon on April 17, 2020, R1 was tested again for COVID-19 due to a fever (100.3° F). P. Ex. 59 at 6. By 3:08 p.m. on April 17, 2020, R1 had a fever of 101.6° F (repeat temperature taken as 100.9° F) and low blood oxygenation. P. Ex. 59 at 6. On April 20, 2020, R1 tested COVID-positive.²⁷ P. Ex. 59 at 6. As a result, Petitioner’s staff administered “COVID meds.” P. Ex. 59 at 6. The nursing entries note a COVID-positive status but do not indicate R1 was placed in isolation. P. Ex. 59 at 6. On May 4, 2020, R1 had a COVID-negative test result. P. Ex. 59 at 5. On May 20, 2020, the facility stopped transmission-based precautions for R1. P. Ex. 59 at 4.

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Surveyors Corbin and Jenkins testified that, on April 21, 2020, R1 was COVID-positive but was allowed to remain on one of the facility’s COVID-negative units. CMS Ex. 27 ¶ 12(c); CMS Ex. 28 ¶ 12(A). Surveyor Corbin observed that: there was a droplet precaution sign on R1’s door; R1’s door was left open; R1 was not wearing a mask; and no station had been set up for staff to safely doff PPE prior to leaving R1’s room. CMS Ex. 27 ¶ 12(B); CMS Ex. 28 ¶ 20(A).

Surveyor Jenkins testified to reviewing R1’s clinical record on April 22, 2020, and noted that there was neither a physician order nor a progress note indicating that R1 was to be placed in isolation. CMS Ex. 28 ¶ 10.

15. Petitioner was noncompliant with42 C.F.R. § 498.80(a) with respect to R1 because Petitioner failed to maintain/implement its COVID-19 ICP and its ICP. The COVID-19 ICP provides that a resident suspected of being infected with COVID-19 must either be isolated in an individual room with the door closed or may be moved to a unit for COVID-positive residents. As of April 17, 2020, Petitioner suspected R1 was infected with COVID-19 due to a fever and tested R1. However, Petitioner’s staff failed to implement the facility’s COVID-19 ICP because it allowed R1 to remain in a COVID-negative unit with R1’s door open. R1 was also unmasked. Petitioner did not establish the means for staff to safely remove their PPE upon leaving R1’s room, as required by the facility’s ICP. Because Petitioner did not fully implement its COVID-19 ICP and its ICP, and this resulted in a potential for more than minimal harm to residents, Petitioner was not in substantial compliance with 42 C.F.R. § 498.80(a).

As stated earlier, the Social Security Act and 42 C.F.R. § 483.80(a) require SNFs to maintain/implement their ICPs. Petitioner’s COVID-19 ICP’s basic rule was:

A resident with known or suspected COVID-19, immediate infection prevention and control measures will be put into place. . . . Patients with known or suspected COVID-19 should be placed in a single person room with the door closed.

CMS Ex. 19 at 27. As stated in conjunction with R2, when there has been a COVID-19 outbreak, the COVID-19 ICP required Petitioner to “[c]ohort residents identified with same symptoms/COVID-19 confirmation,” and “[p]lace residents in private rooms on standard, contact, droplet precautions when and where availability permits.” CMS Ex. 19 at 28.

Just as discussed above concerning R2, Petitioner failed to keep R1’s door closed in contravention of its COVID-19 ICP. Further, Petitioner again did not establish a safe way for staff exiting R1’s room to doff and dispose of PPE used while in R1’s room. In

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R1’s case, Surveyor Corbin testified that there was “a trashcan under the sink that was in the center of the room,” which was problematic “because removing your gown at that area of the room potentially could have contaminated clothing before they left the room.” Tr. 634-35. Based on investigation, Surveyor Corbin testified that facility staff would have been removing their gowns inside R1’s room. Tr. at 635.

Petitioner disagreed and argued that it did implement its COVID-19 ICP with respect to R1. P. Br. at 47-52. Petitioner’s Administrator testified that, on April 17, 2020, R1’s fever was less than 100° F. P. Ex. 71 at 36. Petitioner’s Administrator also testified in conclusory fashion that R1 was isolated on the COVID-negative unit. Further, “given the logistics of relocating residents, moving a resident who already was in a single occupancy room was a relatively low priority, and so our care planning team decided to allow the Resident to stay in isolation in her private room until the entire unit was closed three days later.” P. Ex. 71 at 36. In briefing, Petitioner argues, just as Petitioner’s Administrator testified, that R1’s fever on April 17, 2020, was below 100° F and, thus, not a symptom of COVID-19. P. Br. at 48.

However, the argument and testimony that R1’s temperature was below 100° F are directly contradicted by medical documentation. As explained above, R1’s progress notes show three temperatures taken for R1 on April 17, 2020, above 100° F. P. Ex. 59 at 6. I accept the progress notes as the primary documentation of R1’s temperature.

Petitioner’s Administrator also challenged whether R1’s and R2’s room doors should have been shut because “most residents were behind closed doors at all times” and “[c]losing doors was extremely upsetting to residents, and some actually begged for staff to keep doors open.”²⁸ P. Ex. 71 at 37. Petitioner’s Administrator opined that nurses needed to be able to exercise professional judgment to monitor confused residents or to prevent residents from choking at mealtimes. P. Ex. 71 at 37-38. Dr. Katz testified in a similar way, indicating that leaving the door open was contrary to CDC guidance but may be necessary in nursing facilities based on resident and nursing needs. P. Ex. 76 at 11.

As discussed above in relation to R2, Petitioner’s COVID-19 ICP required that COVID-19 positive or suspected residents have their room doors closed if they were isolating in

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an individual room. Given that R1, like R2, was living on a COVID-negative unit, this requirement was particularly necessary to stop transmission of COVID-19. If R1’s door needed to remain open, R1 should have been transferred out of the COVID-negative unit.

Petitioner also argued that being maskless is not a violation of CDC guidance and that Surveyor Corbin testified that she merely made an observation and was not citing a deficiency. P. Br. at 50. Neither Petitioner’s ICP nor its COVID-19 ICP requires a resident who is isolated to wear a mask at all times in a single-occupancy room. However, R1 being maskless, as with R2, makes the decision to leave R1’s room door open while on a COVID-negative unit more dangerous.

Finally, Petitioner argued, as with R2, that it may be necessary to leave a resident’s door open for the supervision of the resident or because the resident would otherwise be upset by the closed door. P. Br. at 51. Petitioner again asserts that there was no risk of hazard to the door being left open because R1’s bed was a bit more than six feet away from the door. P. Br. at 51-52. These arguments were addressed and rejected above in FFCL 13 regarding R2.

As indicated above concerning R2, I find that Petitioner’s failure to implement its COVID-19 ICP created a potential risk for more than minimal harm to residents in the COVID-negative unit where R1 resided. Petitioner’s COVID-19 ICP states that when there is “[a] resident with known or suspected COVID-19, immediate infection prevention and control measures will be put into place. . . . If symptoms are mild and do not require transfer to the hospital: Patients with known or suspected COVID-19 should be placed in a single person room with the door closed.” CMS Ex. 19 at 27. R1’s situation is egregious because R1’s temperature on April 17, 2024, was high enough that she should have been immediately treated as suspected of having COVID-19. According to Petitioner’s COVID-19 ICP, R1 needed to be kept in R1’s single occupancy room with the door shut. If leaving the door open was necessary for R1, then Petitioner ought to have moved R1 to a COVID-positive unit rather than allowing R1 to remain living on a COVID-negative unit.

In addition, as explained above concerning R2, Petitioner’s failure to properly provide for a safe means for staff to remove PPE before leaving R1’s room, violated Petitioner’s ICP requiring such removal each time staff leaves an infected resident’s room. P. Ex. 41 at 5.

Based on the above, I conclude that Petitioner was not in substantial compliance with 42 C.F.R. § 483.80(a).

16. CMS’s determination that Petitioner’s noncompliance with 42 C.F.R. § 483.80(a) posed immediate jeopardy to resident health and safety is not clearly erroneous.

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As stated in FFCL 10, immediate jeopardy exists if a facility’s noncompliance has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident. 42 C.F.R. § 488.301. The regulation does not require that a resident actually be harmed. Lakeport Skilled Nursing Ctr., DAB No. 2435 at 8 (2012).

I must uphold CMS’s determination as to the level of a facility’s noncompliance (which includes an immediate jeopardy finding) unless it is “clearly erroneous.” 42 C.F.R. § 498.60(c). The “clearly erroneous” standard imposes on facilities a heavy burden to show no immediate jeopardy, and determinations of immediate jeopardy have been sustained where CMS presented evidence “from which ‘[o]ne could reasonably conclude’ that immediate jeopardy exists.” See, e.g., Barbourville Nursing Home, DAB No. 1962 at 11 (quoting Florence Park Care Ctr., DAB No. 1931 at 27-28 (2004)). In reviewing CMS’s finding, I “must consider whether the totality of the allegations support the Agency’s determination that [the SNF’s] noncompliance ‘has caused, or [was] likely to cause, serious injury, harm, impairment, or death to a resident.’” Rosewood Care Ctr., 868 F.3d at 618 (emphasis omitted).

Petitioner argued that CMS provided no direct “plausible evidence that death or serious harm to one or more residents is ‘probable,’ or ‘reasonably to be expected’ from the asserted noncompliance.” P. Br. at 66. Petitioner further argues that “CMS has offered no evidence – expert or otherwise – that any of the alleged noncompliance in the Statement of Deficiencies, or as described at the hearing or in CMS’s Brief, caused any resident to develop COVID-19; exacerbated the course of any resident’s illness; or, more to the point, posed even any plausible possibility, much less ‘likelihood,’ of transmission of the disease to residents who were not already infected.” P. Br. at 66-67.

Petitioner’s argument completely ignores the context of this case when arguing that there is no direct evidence that Petitioner’s failures to implement its COVID-19 ICP and ICP caused any resident to develop COVID-19 or exacerbate any resident’s illness. Petitioner fails to recognize that the deficiencies in this case occurred early in the COVID-19 pandemic when there were no rapid tests, no vaccines, and no proven treatments for COVID-19. The only way to attempt to prevent COVID-19 from spreading was strict adherence to proper infection control measures.

As testified to in detail by Petitioner’s own expert witnesses, and summarized in detail in FFCL 2, COVID-19 was a highly contagious and deadly virus that in a disproportionate manner to the general public caused death among nursing home residents. Petitioner wants me to ignore its own expert witnesses and Petitioner’s experience during an outbreak in early April 2020. That outbreak, in which half of its residents were infected, showed the ease with which COVID-19 could spread.

Further, Petitioner’s exhibits show, during the relevant time period, the remarkable increase in infections and deaths nationwide. They indicate:

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• March 19, 2020: 4,226 confirmed cases and 97 total deaths (P. Ex. 15 at 4)
• March 26, 2020: 54,453 confirmed cases and 737 total deaths (P. Ex. 16 at 4)
• April 2, 2020: 186,101 confirmed cases and 3,603 total deaths (P. Ex. 17 at 4)
• April 8, 2020: 395,011 confirmed cases and 12,754 total deaths (P. Ex. 18 at 4)
• April 15, 2020: 605,390 confirmed cases and 24,582 total deaths (P. Ex. 19 at 4)
• April 22, 2020: 802,583 confirmed cases and 44,575 total deaths (P. Ex. 20 at 4)
• April 29, 2020: 1,005,147 confirmed cases and 57,505 total deaths (P. Ex. 21 at 4)
• May 6, 2020: 1,193,813 confirmed cases and 70,802 total deaths (P. Ex. 22 at 4)

It is clear that, during the time when Petitioner allowed COVID-positive residents to remain living in COVID-negative units, those COVID-positive residents represented a clear danger to the uninfected residents, unless Petitioner complied with proper infection control requirements. In this case, Petitioner disregarded the COVID-19 symptoms displayed by R1 and R2 and allowed their doors to remain open when its own COVID-19 ICP required the doors to be closed. Isolation signs were not placed on their doors until positive test results were received, resulting in a significant risk that individuals would enter R1’s or R2’s rooms without knowing R1 and R2 were suspected of being infected. Even after R1 and R2 were confirmed COVID-positive, Petitioner still ran the risk of allowing the COVID-19 virus to be spread in the COVID-negative unit where they resided, hoping that the virus would not spread a few feet further than six feet and into the hall or that staff providing care to the COVID-negative residents would not be infected by R1 and R2, and in turn, infect the COVID-negative residents.

As to the specific dangers and their likelihood, I credit Dr. Nay’s testimony as comprehensive and specifying the facts relied on for her opinion. CMS Ex. 51 ¶¶ 25-27. Dr. Nay opined that the deficiency involving R1 and R2 immediately jeopardized residents in the facility as follows:

In my expert opinion, the facility failed to isolate two symptomatic residents on a COVID negative unit and failed to sufficiently establish the necessary doffing stations inside the residents’ rooms. These practices in a congregate setting with a highly vulnerable population during an outbreak with a highly transmissible and potentially fatal pathogen created a significant risk of transmission of COVID-19. The facility’s

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failure to implement isolation precautions correctly and effectively created a situation in which Sagepoint’s noncompliance caused or was likely to cause serious harm or death to the residents of Sagepoint.

CMS Ex. 51 ¶ 28. Further, because Petitioner failed to properly follow the isolation precautions contained in its COVID-19 ICP and its ICP, Dr. Nay also opined as follows:

In my expert opinion, despite the CMS waivers, Maryland’s Secretary’s directive, and long-standing standard of care to cohort residents in certain situations, the facility failed to cohort COVID negative and COVID positive residents to the best of their ability during a pandemic. In addition, the facility failed to follow the Secretary’s directive requiring nursing homes, to the best of their ability, to establish a cohort of staff who are assigned to care for known or suspected COVID-19 residents. These failures increased the likelihood that a highly transmissible and potentially fatal pathogen would spread further in a congregate setting with highly vulnerable residents. This created a situation in which Sagepoint’s noncompliance caused or was likely to cause serious harm or death to the residents of Sagepoint.

CMS Ex. 51 ¶ 35. Regarding the question as to how leaving the doors open to R1’s and R2’s rooms created a risk for harm when R1 and R2 had COVID-19 symptoms and were awaiting test results, Dr. Nay testified:

Q. And what -- what risks of harm are there from doors being open in a COVID-positive -- COVID-positive patients having their doors open in a facility?

A. So during the COVID pandemic, they already had an outbreak, the risk is increasing the spread of COVID. These -- initially these residents were suspected COVID then were confirmed for COVID. And with doors open without a sign being hung up, people walking by whether it was staff that floated in or a visitor for compassionate care or some other employee coming by, wouldn’t know that that person was supposed to be isolated. This would increase the likelihood of the spread of this disease.

Q. And why is that?

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A. Because people could go in without the proper PPE on, that the -- you could -- staff members weren’t caring for that heard a call bell or something else may go in the room not realizing that this person was suspect for COVID or COVID-positive.

Tr. 291. Dr. Nay clarified this opinion as follows:

It is likely that a staff member would have gone into the room not knowing that resident number 1 or resident number 2 had symptoms consistent with COVID at the time while the tests were pending. They were symptomatic and the staff had no way to know that those particular individuals were symptomatic and were on a COVID-negative unit.

Tr. 562. Also, during this period of time, i.e., while R1 and R2 had symptoms but before the tests revealed they were COVID-positive, Dr. Nay expressed concern that staff, not knowing R1 and R2 had symptoms due to the lack of an isolation sign, would not know to change their PPE after leaving R1’s and R2’s rooms before going to another resident’s room or to a common area. Tr. 564.

Dr. Katz testified that national standards recommended that COVID-positive residents be cohorted together if possible. Tr. 355-356. Further, Dr. Katz testified to the following that supports the immediate jeopardy determination:

Q. And, Dr. Katz, isn’t it true that a nursing home staff failure to properly isolate COVID-19 infected residents who are symptomatic renders residents vulnerable to COVID-19 infection, which is likely to cause serious illness or death to residents?

A. Yes.

Tr. 362-363. This testimony is significant in light of the fact that Dr. Katz admitted that she never reviewed the medical records for R1 and R2 and was not aware that there were reasons why R1 and R2 needed their doors left open to be monitored. Tr. 404. Dr. Katz was also unaware that Petitioner did not place isolation signs on R1’s and R2’s doors after manifesting COVID-19 symptoms and while awaiting test results. Tr. 404.

It is not surprising that Dr. Katz also agreed that SNFs need to rigorously implement their ICPs. Tr. 332. In the instances of R1 and R2, Petitioner did not rigorously implement its ICPs and, given the infectious and deadly nature of the COVID-19 virus, such a failure immediately jeopardized facility residents. COVID-19 presented one of the most

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contagious and deadliest pandemics to sweep across the United States, particularly for residents in nursing homes. In those early days of the pandemic, SNFs needed to scrupulously implement their ICPs. Failure to do so left residents exposed to a disease that was particularly dangerous to them.

Enforcement Remedy

17. The amount and duration of the $15,930 per-day CMP imposed from April 29, 2020 through May 5, 2020, were not challenged and are, therefore, reasonable.

CMS imposed on Petitioner a $15,930 per-day CMP for seven days from April 29, 2020, through May 5, 2020. CMS Ex. 26 at 1-2. Petitioner disputed the deficiencies underlying the imposition of this penalty as well as the findings of immediate jeopardy, but Petitioner did not expressly challenge the CMP’s amount or duration.

An SNF bears the burden of showing that its noncompliance was of shorter duration than alleged by CMS. Owensboro Place & Rehab. Ctr., DAB No. 2397 at 12 (2011) (citing Kenton Healthcare, LLC, DAB No. 2186 at 24-25 (2008); Lake Mary Health Care, DAB No. 2081 at 30 (2007)). Petitioner has made no attempt to show the duration should be shorter. Therefore, I accept the duration as found by CMS.

When determining whether a CMP amount is reasonable, I am to apply the factors listed in 42 C.F.R. § 488.438(f): 1) the facility’s history of noncompliance; 2) the facility’s financial condition; 3) the factors specified in 42 C.F.R. § 488.404; and 4) the facility’s degree of culpability, which includes neglect, indifference, or disregard for resident care, comfort, or safety. See 42 U.S.C. §§ 1320a-7a(d)(2), 1395i-3(h)(2)(B)(ii)(I). The absence of culpability is not a mitigating factor. 42 C.F.R. § 488.438(f). The factors listed in 42 C.F.R. § 488.404 include: 1) the scope and severity of the deficiency; 2) the relationship of the deficiency to other deficiencies resulting in noncompliance; and 3) the facility’s prior history of noncompliance in general and specifically with reference to the cited deficiencies. See 42 U.S.C. §§ 1320a-7a(d)(1), (3), 1395i-3(h)(2)(B)(ii)(I).

The regulations leave the decision regarding the choice of remedy to CMS, and the amount of the remedy to CMS and the ALJ, requiring only that the regulatory factors at 42 C.F.R. §§ 488.438(f) and 488.404 be considered when determining the amount of a CMP within a particular range. 42 C.F.R. §§ 488.408, 488.408(g)(2), 498.3(d)(11); see also 42 C.F.R. § 488.438(e)(2), (3); Alexandria Place, DAB No. 2245 at 27 (2009); Kenton Healthcare, LLC, DAB No. 2186 at 28-29 (2008). However, unless a facility contends that a particular regulatory factor does not support the CMP amount, an ALJ must sustain it. Coquina Ctr., DAB No. 1860 (2002).

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As CMS points out, Petitioner claimed that the imposition of the CMP in this case would cause the facility to divert funds from patient care; however, Petitioner neither expressly challenged the amount of the CMP based on financial hardship nor submitted documentary evidence to show such potential financial hardship. CMS Reply at 25-26; P. Br. at 10. As CMS noted, CMS advised Petitioner in the initial determination of the opportunity to claim financial hardship and to have CMS consider a request to decrease the CMP. CMS Reply at 25; CMS Ex. 26 at 2. However, there is no evidence Petitioner availed itself of this opportunity. Therefore, I conclude that Petitioner did not challenge the amount of the CMP and uphold it.

I note that the $15,930 per-day CMP amount is approximately in the middle of the $6,808 to $22,320 per day range provided in the regulations for immediate jeopardy noncompliance. 45 C.F.R. § 102.3 (2020); 85 Fed. Reg. 2869, 2870, 2880 (Jan. 17, 2020). It is more than $6,000 per day lower than the maximum penalty that could have been imposed.

VI. Conclusion

I conclude that Petitioner was not in substantial compliance with 42 C.F.R. §§ 483.50(a)(1) and 483.80(a)(1)-(2). Further, I conclude that CMS’s determination that Petitioner’s noncompliance immediately jeopardized the health and safety of residents is not clearly erroneous. Finally, a $15,930 per-day CMP for seven days from April 29, 2020 through May 5, 2020, is appropriate and reasonable.

Endnotes

¹ “It is the duty and responsibility of the Secretary to assure that requirements which govern the provision of care in skilled nursing facilities . . . are adequate to protect the health, safety, welfare, and rights of residents and to promote the effective and efficient use of public moneys.” 42 U.S.C. § 1395i-3(f)(1).

² All citations to the Code of Federal Regulations are to the version in effect at the time of the survey unless otherwise indicated.

³ State agencies designate the scope and severity level using a matrix published in the State Operations Manual, ch. 7, § 7400.3.1 (Rev. 185, eff. Nov. 16, 2018), available at https://www.cms.gov/regulations-and-guidance/guidance/manuals/downloads/som107c07pdf.pdf. Scope and severity levels of A, B, or C are deficiencies for which CMS cannot impose enforcement remedies. Scope and severity levels of D, E, or F are deficiencies that present no actual harm, but have the potential for more than minimal harm that do not amount to immediate jeopardy. Scope and severity levels of G, H, or I are deficiencies that involve actual harm that do not amount to immediate jeopardy. Scope and severity levels of J, K, and L are deficiencies that constitute immediate jeopardy to resident health or safety.

⁴ Ms. Dwyer is Petitioner’s Administrator. Although Ms. Dwyer is licensed as a nursing home administrator and has many years of experience as an administrator, Ms. Dwyer does not have a health care-related degree and is not a health care provider. Tr. 12-20. Therefore, I do not give weight to Ms. Dwyer’s testimony that provides an opinion or conclusion as to scientific, clinical, or medical matters at issue in this case. Further, Ms. Dwyer’s written testimony recounts the alleged testimony of witnesses at a Maryland State ALJ hearing; however, Ms. Dwyer did not cite to the lengthy transcript from that hearing. See P. Ex. 1. As a result, I do not consider those alleged statements when rendering this decision.

⁵ Dr. Nay is an expert witness for CMS in this case. Dr. Nay has been a licensed physician in Maryland since 1997. CMS Ex. 51 ¶ 1; CMS Ex. 29 at 17. Dr. Nay is board certified in family medicine, a fellow of the American Academies of Family Medicine and of Hospice and Palliative Medicine, and a Certified Medical Director for SNFs. CMS Ex. 51 ¶ 2; CMS Ex. 29 at 16. For a decade, Dr. Nay provided care to SNF residents as an attending physician and subsequently served in Medical Director positions in SNFs. CMS Ex. 51 ¶¶ 3-6; CMS Ex. 29 at 14. She later served five years as the Medical Director for Maryland DOH’s Office of Health Care Quality (OHCQ) until, in 2013, Dr. Nay became the Executive Director for OHCQ. CMS Ex. 51 ¶¶ 8-14; CMS Ex. 29 at 12-13. Petitioner asserted that Dr. Nay “has little or no relevant expertise at all regarding these underlying issues.” Petitioner argues I should accept the unbiased testimony from the independent experts that Petitioner presents. P. Br. at 3-4 n.1. As an initial matter, Dr. Nay’s extensive experience serving as the attending physician for SNF residents and as Medical Director for SNFs certainly qualifies her to opine on the deficiency in this case involving an SNF’s obligation to have a method for ensuring timely receipt of laboratory results. In fact, of the expert witnesses who testified in this case, she is the most qualified to speak to that point. Further, Dr. Nay’s experience with SNFs provides highly useful knowledge for the necessary infection control practices that SNFs need to employ. While Petitioner presents an expert witness in the field of infectious diseases, this does not necessarily mean that Dr. Nay’s opinion is rendered useless. Neither of Petitioner’s medical expert witnesses has experience treating residents in an SNF setting. Tr. 372 (Dr. Katz only treats patients in the hospital); Tr. 483-484 (Dr. McEachern has not treated residents in a nursing home). Further, Petitioner has not shown bias on Dr. Nay’s part any more than any expert witness may be suspected of bias when testifying on behalf of a party. Petitioner’s expert witnesses suffer from that same potential bias. I find Dr. Nay’s testimony to be useful and Dr. Nay to be credible as a witness consistent with my discussion below that addresses Dr. Nay’s specific testimony. Finally, I agree with CMS that Petitioner’s excessive personal attacks on Dr. Nay are unfounded. CMS Reply at 19-21.

⁶[6] Dr. Katz is an expert witness for Petitioner. Dr. Katz completed an infectious disease fellowship at Johns Hopkins University and then joined the faculty of that school in 2017 as an Assistant Professor of Infectious Disease. P. Ex. 76 at 1, 15. In that position, Dr. Katz conducts research and treats patients with COVID-19 in a hospital setting. P. Ex. 76 at 1. Dr. Katz served as the COVID-19 response incident commander for long-term care for the Johns Hopkins Health System. P. Ex. 76 at 2, 15. Dr. Katz has authored academic papers regarding infection prevention and clinical practices in long-term care facilities during the COVID-19 pandemic. P. Ex. 76 at 2; see also P. Exs. 63-64. I find Dr. Katz’s testimony to be useful and Dr. Katz to be credible as a witness. However, as discussed below, I do not find that Dr. Katz’s testimony is always consistent with the record or reasonable. Those specific instances are discussed below.

⁷ Professor Grabowski is an expert witness for Petitioner in this case. Professor Grabowski is a professor of health care policy at Harvard Medical School, with a focus on long-term care service delivery. P. Ex. 77 at 1. In 2020, Professor Grabowski served on a CMS COVID-19 commission concerning safety and quality at SNFs. P. Ex 77 at 1. With exception of a bachelor’s degree in psychology, all of Professor Grabowski’s other degrees are in public policy and Professor Grabowski is not a clinician. P. Ex. 77 at 10; Tr. 426-427. Therefore, Professor Grabowski’s testimony is of limited value in this case.

⁸ Dr. McEachern is an expert witness for Petitioner in this case. Dr. McEachern has practiced medicine since 1990 and is board certified in pediatrics, which is Dr. McEachern’s field of practice. P. Ex. 78 at 1, 20. Dr. McEachern has not practiced medicine at long-term care facilities, is not specialized in infection control, and has not treated elderly patients who had COVID-19. P. Ex. 78 at 1-2; Tr. 483-484. I find Dr. McEachern’s testimony to be of much more limited value than that of Dr. Katz and Dr. Nay, both of whom have expertise and experience that is more relevant to this case. Tr. 489-491, 496-497.

⁹ At the outset of this case, the witness’s name was Wendi Beckley. See CMS Ex. 27 at 1. However, at the hearing, the witness indicated a change in surname to Corbin. Tr. 600, 603-604. In this decision, I refer to this witness as Surveyor Corbin or Ms. Corbin.

¹⁰ There is no exhibit marked as CMS Exhibit 52.

¹¹ The statute applicable to the present case requires the Secretary to “give [ ] written notice and an opportunity for the determination to be made on the record after a hearing at which the person is entitled to be represented by counsel, to present witnesses, and to cross-examine witnesses against the person.” 42 U.S.C. § 1320a-7a(c)(2) (made applicable to SNF CMP cases by 42 U.S.C. § 1395i-3(h)(2)(B)(ii)(I)). The APA’s formal hearing provisions apply to this case because, with limited exceptions not applicable here, those provisions apply “in every case of adjudication required by statute to be determined on the record after opportunity for an agency hearing.” 5 U.S.C. § 554(a).

¹² As seen below, my analysis of the infection control deficiency in this case turns on Petitioner’s failure to fully implement its infection control program rather than its compliance or non-compliance with CDC guidance documents.

¹³ Although CMS alleged noncompliance with four requirements in the regulations, CMS only alleged that two of the deficiencies involved immediate jeopardy-level noncompliance (i.e., 42 C.F.R. §§ 483.50(a)(1)(i) and 483.80(a)(1)-(2)). As explained below, I uphold these two deficiencies at the immediate jeopardy level. Because I also conclude that those deficiencies fully support the CMP imposed on Petitioner, it is unnecessary for me to decide whether Petitioner was in substantial compliance with the non-immediate jeopardy-level deficiencies alleged in this case (i.e., 42 C.F.R. §§ 483.21(b)(1) and 483.70). See Claiborne-Hughes Health Ctr. v. Sebelius, 609 F.3d 839, 847 (6th Cir. 2010); Carrington Place of Muscatine, DAB No. 2321 at 20-21 (2010).

¹⁴ SARS-COv-2 is the novel coronavirus that causes COVID-19. P. Ex. 25 at 1.

¹⁵ Although the record is clear that at least one of R4’s children raised this matter with Petitioner, the record provides more support that it was R4’s son who requested to learn the results of the test. Tr. 32; CMS Ex. 34 at 1-2.

¹⁶ Surveyor Jenkins testified that, shortly before the hearing, Diamond Laboratories sent Jenkins a copy of a message from Diamond Laboratories’ Chief Operating Officer that indicated the laboratory had not received a sample from R4 to test. Tr. 726-727. In addition, Diamond Laboratories indicated that it had an order from around April 6, 2020, for the test to be done but did not have a test result concerning R4 for that date range (it allegedly claimed to only have a test result from November 2020). Tr. 727, 731. I find that the evidence of record shows that Petitioner collected a sample from R4 for testing on April 6, 2020, Diamond Laboratories received R4’s sample on April 7, 2020, and Diamond Laboratories had a test result on April 9, 2020. P. Ex. 89. Until Surveyor Jenkins’ cross-examination at the hearing, neither party disputed that Petitioner received the COVID-19 test result from Diamond Laboratories on April 20, 2020, through Diamond Laboratories’ web portal. I do not consider Surveyor Jenkins’ testimony, which was unsupported by documentation, as sufficient to contradict the test report document that the DON obtained from Diamond Laboratories’ web portal. P. Ex. 89; Tr. 819-820, 832-35.

¹⁷ According to Surveyor Jenkins, at some point after the survey but before the hearing in this case, he reviewed line listings for Petitioner’s facility for April 6, 14, and 16-18, 2020 that Petitioner had submitted to the local health department. Tr. 725-26.

¹⁸ When asked about documentation showing the room transfer, the Administrator oddly pointed to the surveyors’ notes rather than a facility document. Tr. 66, 67.

¹⁹ Dr. McEachern testified consistently with Dr. Katz when he discussed the use of private rooms to cohort COVID-positive residents, even when the private rooms were on COVID-negative units. “If you have private rooms, they can be on a floor that is not even a -- designated a COVID floor as long as people understand that there are COVID rooms” so that precautions can be taken. Tr. 489. Although Dr. McEachern later indicated that signage was optimal but might not be necessary if all of the staff knew a resident was COVID-positive (Tr. 506), the testimony is clear that Petitioner’s staff needed to know which residents were COVID-positive to implement and maintain isolation.

²⁰ Petitioner’s COVID-19 infection control program states that “Discontinuation of Isolation Precautions will be determined on a case-by-case basis in conjunction with the State and/or Local Health Department.” CMS Ex. 19 at 29. The record does not show that Petitioner discussed R4’s discontinuation of isolation precautions with state or local authorities, indicating that R4 had never been on such precautions.

²¹ Petitioner’s failure to provide evidence to show that R4 was isolated while infectious is exemplified by a compound question that Petitioner’s counsel posed to Dr. Nay:

During the delay in obtaining a test result, resident number 4 remained on a COVID-negative unit. The surveyors weren’t there, so they don’t know what happened during that time, right? They don’t know whether she was mixing with other residents, whether there was a sign on the door, whether the staff wore PPE, right? So all they know is what they saw after they arrived, right?

Tr. 242-243. However, it is Petitioner who must come forward with evidence as to “what happened” during the time period when R4 was infectious.

²² The Social Security Act requires the Secretary to establish criteria to assess whether an SNF is effectively and efficiently providing laboratory services. 42 U.S.C. § 1395i-3(d)(1), (f)(5)(E). The Secretary responded by promulgating 42 C.F.R. § 483.50(a)(1). The Secretary originally promulgated this requirement under 42 C.F.R. § 483.75(j)(1) but later transferred the regulatory text, without modification, to 42 C.F.R. § 483.50(a)(1). 81 Fed. Reg. 68,688, 68,774 (Oct. 4, 2016); 56 Fed. Reg. 48,826, 48,878 (Sept. 26, 1991). Therefore, in this decision, I cite cases that interpreted § 483.75(j)(1) before the relevant text was transferred to § 483.50(a)(1).

²³ On April 5, 2020, the Maryland Secretary of Health issued a directive that included a provision on “Outbreak Prevention and Testing” that stated: “Pursuant to a health care provider’s order for COVID-19 testing, all nursing homes shall use the most expeditious means available (either a hospital lab, private lab, or the Maryland State Laboratory).” CMS Ex. 21 at 2 (emphasis added). Therefore, Petitioner’s testing efforts were consistent with the directive issued a day before Petitioner obtained test samples from its residents.

²⁴ Petitioner submitted as an exhibit the same COVID-19 ICP that CMS did, which has a March 27, 2020 effective date. Compare CMS Ex. 19 at 26-35 with P. Ex. 47 at 1-10. However, Petitioner also submitted a different version of Petitioner’s COVID-19 ICP, which also has an effective date of March 27, 2020. P. Ex. 47 at 11-25. The second version of the COVID-19 ICP has additional provisions, some of which indicate a date of May 19, 2020. P. Ex. 47 at 13, 15. As a result, I apply the version of Petitioner’s COVID-19 ICP that both parties submitted because that appears to have been the most likely version in place during the relevant time period to this case.

²⁵ CMS’s exhibit list indicates that CMS Exhibit 33 comprises R2’s medical records. However, based on a document purporting to be a summary of R2’s medical records from April 3 through May 8, 2020 (i.e., CMS Exhibit 10 at 137-141) submitted by Petitioner with its IDR request, it appears likely that CMS Exhibit 33 does not include all of R2’s records. As a result, in post-hearing briefing, CMS relies on information from this summary. CMS Br. at 12-13, 40. I cannot assume the accuracy of the summary because, as CMS stated when it objected to this summary (which was also separately submitted as Petitioner Exhibit 57), it lacks foundation, is of unknown authorship, and is based on unknown sources of information. CMS’s Objections to P. Proposed Exhibits and P.’s Witness Testimony at 2. I sustained the objection and excluded Petitioner Exhibit 57. Notice of Hearing at 8. However, because this document was admitted as part of CMS Exhibit 10, which is Petitioner’s extensive IDR request, I will consider statements in the summary that are contrary to Petitioner’s position in this case because Petitioner submitted this document twice and, in all probability, is responsible for its creation. Further, Petitioner has never explained why it submitted a summary of R2’s medical records rather than the actual records.

²⁶ A resident may be maskless when isolated in a room alone. However, the fact that R2, and as discussed below, R1, were maskless, means that these COVID-positive residents were expelling COVID-virus into the air while their room doors were open. As Surveyor Corbin testified: “I have explained that my observation was being documented and my observation was, the door was open and there was no mask on the resident to contain the COVID-19.” Tr. at 634. Therefore, all references in this decision to the observations that R1 and R2 were maskless refer to this explanation.

²⁷ Petitioner’s Administrator testified that R1’s COVID-positive test result was received on April 20, 2020. Because the progress notes are not inconsistent with that testimony (i.e., an April 21, 2020 entry presumes the test result was already received), I credit the Administrator’s testimony on that point. P. Ex. 59 at 6; P. Ex. 71 at 36.

²⁸ Petitioner’s Administrator testified that there are photographs in the record showing the state agency surveyors arriving on one of the COVID-positive units and all of the resident room doors pictured were closed. P. Ex. 62; P. Ex. 71 at 37. CMS’s allegations concerning COVID-positive residents whose resident room doors were left open related to R1 and R2, who were on a COVID-negative unit. CMS Ex. 12 at 24. Therefore, Petitioner’s photographs do not resolve CMS’s allegations. They do make one question why Petitioner was so careful to keep the doors closed on a unit filled with infected residents but so careless as to leave the doors open to R1 and R2, who were suspected of having COVID and then proven to have it.