Life Care Center of St. Louis, CR6286 (2023)

DECISION

Early in the coronavirus disease of 2019 (COVID-19) pandemic, Life Care Center of St. Louis (Petitioner or facility) had a significant COVID-19 outbreak among residents and staff that resulted in seven resident deaths.  This case does not purport to determine specifically how COVID-19 entered the facility or why it spread in the facility.  Rather, this case determines if Petitioner’s staff fully complied with Petitioner’s infection prevention and control program (IPCP) requirements and, if breaches to the IPCP occurred, whether such breaches had the potential for causing more than minimal harm to facility residents. 

The Centers for Medicare & Medicaid Services (CMS) determined that Petitioner’s staff failed to consistently screen all staff from mid-March to mid-May 2020 for fever or respiratory infection symptoms when commencing their shifts.  CMS also determined that, in mid-May 2020, facility staff failed to comply with Petitioner’s IPCP concerning Personal Protective Equipment (PPE). 

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Petitioner disputes some of the specific allegations in the Statement of Deficiencies (SOD) issued after the survey of the facility.  Further, Petitioner argues that any possible lapses in the IPCP did not provide a potential for more than minimal harm to residents. 

As explained below, while I do not uphold all instances where Petitioner’s staff was alleged to have violated the IPCP, I uphold enough of the allegations to conclude that Petitioner was not in substantial compliance with the requirement that it maintain/ implement its IPCP.  While some of the breaches may seem minor, they had the potential for causing more than minimal harm to residents.  As made clear by Petitioner’s expert witnesses, COVID-19 is an extremely contagious disease and was particularly dangerous to medically vulnerable residents in the skilled nursing facility (SNF) setting.  As a new disease, there was imperfect knowledge of how it was transmitted.  During the dates relevant to this case, there was an inability to quickly test individuals for the virus.  Despite this, or perhaps because of this, SNFs needed to assiduously follow their IPCPs to try to protect SNF residents to the best extent possible. 

In addition to upholding the deficiency alleged in this case, I uphold the amount and duration of the civil money penalty (CMP) imposed on Petitioner because Petitioner did not dispute the duration or the amount of the CMP. 

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). 

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 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

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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.  See 42 C.F.R. pt. 483, subpt. B.²  

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-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 program 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).

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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 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).

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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 St. Louis, Missouri.  CMS Ex. 1 at 1. 

From May 14, 2020 through May 18, 2020, surveyors from CMS conducted a COVID-19 Focused Infection Control Survey of the facility.  CMS Ex. 1 at 1.  In a SOD, CMS determined that the facility was not in substantial compliance with 42 C.F.R. § 483.80(a)(1), (2), (4), (e), (f) (Tag F-880) (Infection Prevention & Control) at a scope and severity level of “L.”  CMS Ex. 1.  On May 14, 2020, the CMS surveyors informed the facility’s Administrator that Petitioner was immediately jeopardizing the health and safety of its residents.  CMS Ex. 1 at 1.  At the completion of the survey, on May 18, 2020, CMS notified the facility Administrator that the immediate jeopardy situation had not been abated.  CMS Ex. 15. 

In a May 19, 2020 notice of initial determination, CMS notified Petitioner that, based on the deficiency findings in the SOD, CMS would involuntarily terminate Petitioner’s Medicare provider agreement effective June 10, 2020, and would impose a Denial of Payment for New Admissions (DPNA) effective May 21, 2020.  CMS Ex. 16 at 2-3.  

On May 21, 2020, CMS conducted a revisit survey at the facility and determined the facility was still not in substantial compliance with 42 C.F.R. § 483.80 and the immediate jeopardy was still ongoing.  CMS Ex. 19. 

On May 28, 2020, CMS conducted a second revisit survey and determined the facility had returned to substantial compliance with 42 C.F.R. § 483.80 by May 26, 2020.  CMS Ex. 22.  

By letter dated June 2, 2020, CMS notified Petitioner that the May 28, 2020 second revisit survey confirmed that the facility removed and corrected the immediate jeopardy noncompliance cited in the SOD.  CMS confirmed that Petitioner attained substantial compliance as of May 26, 2020.  CMS Ex. 24 at 1.  CMS also notified Petitioner that the DPNA was effective from May 21, 2020 through May 25, 2020.  CMS Ex. 24 at 2. 

In a June 9, 2020 notice of initial determination, CMS notified Petitioner that CMS was rescinding the involuntary termination that was to be imposed effective June 10, 2020.  CMS also imposed on Petitioner a CMP of $6,525 per day from March 11, 2020 through May 25, 2020, for noncompliance with 42 C.F.R. § 483.80(a)(1) and (2).  CMS identified the total CMP amount as $495,900.  CMS Ex. 25 at 1. 

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Petitioner timely requested a hearing to dispute the findings in the SOD and the imposition of a CMP.  Petitioner did not timely dispute the imposition of the DPNA and indicated that the DPNA was not an issue in this case.  In response to the hearing request, the Civil Remedies Division acknowledged receipt of the hearing request and issued my Standing Prehearing Order (SPO). 

In conformity with the SPO, CMS filed a combined prehearing brief and motion for summary judgment.  CMS also submitted 29 proposed exhibits, which included the written direct testimony of one witness (CMS Ex. 29).  Petitioner then filed a prehearing brief in opposition to the motion for summary judgment and 54 proposed exhibits, which included written direct testimony for eight witnesses (P. Exs. 47-54).⁴  Along with its prehearing exchange, Petitioner requested to cross-examine CMS’s witness and objected to CMS Exhibits 2 through 12 and 18.  CMS filed a reply brief which included a response to Petitioner’s evidentiary objections.  CMS also requested to cross-examine four of Petitioner’s witnesses (P. Exs. 47-50). 

On January 6, 2022, I issued a Notice of Hearing in which I set a hearing for March 24-25, 2022, so that the parties could cross-examine witnesses.  In the notice, I denied CMS’s summary judgment motion, overruled all of Petitioner’s evidentiary objections, and admitted all of the parties’ proposed exhibits into the record.  Although I admitted all of the proposed exhibits, I indicated that I had only provisionally admitted the written direct testimony for the witnesses who were to be cross-examined at the hearing (CMS Ex. 29; P. Exs. 47-50).  I informed the parties that the written direct testimony for each witness would be deemed fully admitted into the record once the witness had been cross-examined or the request to cross-examine the witness had been withdrawn. 

On March 24-25, 2022, I held a hearing at which Petitioner cross-examined CMS’s witness (Amanda Spicer, R.N. (CMS Ex. 29)) and CMS cross-examined three of

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Petitioner’s witnesses (Sean Buckley (P. Ex. 47); Julie K. Gammack, M.D. (P. Ex. 48); and Terri Anderson, R.N. (P. Ex. 50)).⁵  

CMS was unable to cross-examine Cheri Branch, R.N. (P. Ex. 49) because Ms. Branch did not appear and testify at the hearing.  Therefore, CMS moved for the exclusion of Ms. Branch’s written direct testimony.  Tr. I at 11.  Petitioner opposed CMS’s motion.  Tr. I at 13-14. 

Petitioner’s counsel had originally stated at the hearing that Ms. Branch would not be testifying because “we, to be honest, have not been able to find her . . . .” Tr. I at 7.  During his response to CMS’s motion to exclude Ms. Branch’s written direct testimony, Petitioner’s counsel indicated that the case was nearly two years old (from the CMS survey) and “Ms. Branch has become unavailable, for whatever reason, in the interim”; therefore, the written direct testimony should be admitted, and the testimony judged by its consistency with the rest of the record.  Tr. I at 13.  Petitioner’s counsel also argued that excluding the written direct testimony would create due process issues.  Tr. I at 14. 

Based on Petitioner’s counsel’s representations, I asked him the following:  “[Y]ou’d indicated that you were unable to find Ms. Branch, I just want to make sure I understand that, are you saying that you have absolutely no idea where she is or are you saying that you’ve had, essentially, difficulty communicating with her?” Petitioner’s counsel responded that he had attempted to contact Ms. Branch dozens of times with no response but admitted that Petitioner’s Administrator contacted Ms. Branch “a few months ago” and “Ms. Branch indicated to Mr. Buckley that she would not participate.” Tr. I at 15-16.  Petitioner’s counsel further admitted that Ms. Branch is “several jobs down the road and has no interest in this case at this point.” Tr. I at 16. 

I stated that a missing witness is different than a witness who refuses to testify and noted that Petitioner’s counsel ought to have requested a subpoena to compel Ms. Branch to testify at the hearing.  Tr. I at 16; see also 42 C.F.R. § 498.58(c)(2); SPO ¶ 8 (requiring subpoena requests to include the name and location of the witness).  I also noted that CMS’s right to cross-examine a witness was required by a duly promulgated regulation.  Tr. I at 16; 42 C.F.R. § 498; see also 5 U.S.C. § 556(d).  In response, Petitioner’s counsel claimed that Civil Remedies Division ALJ subpoenas are not enforceable.  Tr. I at 17.  I stated that the Social Security Act (Act) provides for the issuance of subpoenas to compel attendance at administrative hearings and for the enforcement of those subpoenas

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in federal district court.  Tr. I at 17; see 42 U.S.C. § 405(d)-(e).⁶   Therefore, I excluded Ms. Branch’s written direct testimony (P. Ex. 49) from the record.  Tr. I at 16-17.  However, I gave Petitioner the opportunity to produce Ms. Branch as a witness before the hearing ended.  Tr. I at 212-213.  Although Mr. Buckley spoke with Ms. Branch on the evening of the first day of the hearing, Ms. Branch would not agree to appear.⁷   Tr. II at 38. 

At the hearing and in my April 21, 2022 Notice of Receipt of Transcript and Order Setting Post-Hearing Briefing Schedule, I directed the parties to provide all arguments in post-hearing briefs that they wanted me to consider and that I would not review the prehearing briefs when rendering my decision.  Tr. II at 58-59.  The parties timely filed post‑hearing briefs (CMS Br., P. Br.) and CMS filed a reply brief (CMS Reply). 

On April 14, 2023, I issued an Order indicating that I was concerned that I did not have jurisdiction to adjudicate one of the issues I identified in this case.  I explained my concerns and provided the parties with an opportunity to file their positions on the matter.  I also provided the parties with an opportunity to provide any additional arguments that they may have as to the amount of the CMP in this case.  Both parties filed responses (P. Response; CMS Response) to the April 14 Order. 

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III.    Issues

The following are the issues I decide in this case: 

1. Whether Petitioner was in substantial compliance with the Medicare requirements for skilled nursing facilities at 42 C.F.R. § 483.80(a)(1)-(2).⁸ 
2. If Petitioner was not in substantial compliance with 42 C.F.R. § 483.80(a)(1)-(2), whether the amount and duration of the per‑day CMP appropriate under the Act and the regulations. 

As mentioned earlier, CMS imposed a DPNA on Petitioner in a May 19, 2020 notice of initial determination.  CMS Ex. 16 at 3.  In a June 2, 2020 letter, CMS notified Petitioner that the DPNA was effective from May 21, 2020 through May 25, 2020.  CMS Ex. 24 at 2.  Petitioner did not timely file a hearing request to dispute the imposition of the DPNA, and, in its hearing request disputing the CMP, Petitioner acknowledged that the DPNA was not an issue in this case.  Hearing Req. at 2. 

Also mentioned above, on April 14, 2023, I issued an Order indicating that I no longer believed that I had jurisdiction over one of the issues I had originally identified in this case.  That issue is the following: 

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

In the April 14 Order, I stated the following: 

CMS asserts that the $6,525 per-day CMP is the bottom of the upper CMP range (i.e., the CMP range for deficiencies that immediately jeopardize the health and safety of residents).  CMS Post-Hearing Brief at 26-27; 42 C.F.R. §§ 488.408(d)(3)(ii), (e)(1)(iv), 488.438(a)(1)(i).  However, CMS’s initial determination imposing the CMP was dated June 9, 2020.  CMS Ex. 25 at 1.  After inflation adjustments, the bottom CMP amount for the upper CMP range applicable at that time was $6,808 and the top amount for a CMP in the

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lower range was $6,695.  45 C.F.R. § 102.3 (2020); 85 Fed. Reg. 2869, 2870, 2880 (Jan. 17, 2020).  Therefore, the CMP that CMS imposed on Petitioner fits squarely in the lower CMP range for deficiencies that do not constitute immediate jeopardy.  42 C.F.R. §§ 488.408(d)(1)(iii), (2), 488.438(a)(1)(ii).  

The scope of my review is limited by the regulations.  I can decide whether to uphold or reverse the alleged deficiencies in a case.  42 C.F.R. §§ 488.408(g)(1), 498.3(b)(13).  If I uphold one or more deficiencies, I can review the amount of the CMP that CMS imposed under the statutory and regulatory factors established for setting a CMP.  42 C.F.R. § 488.438(e)(3).  However, I cannot review CMS’s discretionary decision to impose a CMP or any other remedy, and I cannot reduce a CMP to zero.  42 C.F.R. §§ 488.438(e)(1)-(2); 488.408(g)(2), 498.3(b)(13).  Most importantly for the present case, I can only review the level of noncompliance found by CMS “if a successful challenge on this issue would affect . . . [t]he range of civil money penalty amounts that CMS could collect . . . .” 42 C.F.R. § 498.3(b)(14).  

In this case, it appears that CMS imposed a CMP at the high end of the lower range.  Therefore, a successful challenge to the immediate jeopardy determination would not impact the range of the penalty because CMS already selected a penalty from the lower range.  Therefore, I no longer believe that the second issue I identified in the Notice of Hearing is an issue in this case. 

Petitioner disagreed with my assessment in a lengthy response.  While Petitioner’s argument lacks focus and clarity, it appears that Petitioner believes it has a right to appeal CMS’s immediate jeopardy determination because:  1) it affected Petitioner’s “five star” rating (P. Response at 2); 2) CMS’s error should not insulate CMS’s immediate jeopardy determination from review (P. Response at 2); 3) 42 U.S.C. § 1320a-7a provides SNFs with the right to review all immediate jeopardy findings by CMS (P. Response at 8); 4) the CMP penalty ranges established in the regulations were never intended to limit appeal rights under 42 U.S.C. § 1320a-7a (P. Response at 10-11); and 5) the severity of a deficiency must be considered when determining the amount of a CMP (P. Response at 11).  Petitioner asserts that “the appropriate response to such a technical or computational error at this point in the appeal is for the Court simply to disregard it.” P. Response at 5. 

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CMS responded that I lack jurisdiction to review its immediate jeopardy finding.  CMS stated that:  1) it made an error when it imposed a per-day CMP in the lower range of penalties instead of in the upper range (CMS Response at 4); 2) a review of the per-day CMP amount that was imposed would not result in the range of penalties changing should the immediate jeopardy determination be overturned (CMS Response at 4); and 3) CMS’s error resulted in a potential loss to the government of over $21,000 in penalties (CMS Response at 3).  CMS also stated that it did not intend to retract the immediate jeopardy determination.  CMS Response at 5.  Finally, CMS proposed remand to CMS to correct the penalty amount as a remedy to this situation.  Following remand, the immediate jeopardy determination would become appealable.  CMS Response at 5. 

As an initial matter, I note that Petitioner did not support CMS’s suggestion that I remand this case so that CMS could correct its error and raise the per-day CMP amount.  This would have been the most effective way for Petitioner to ensure review of the immediate jeopardy determination.  Although CMS invited such a remand (see 42 C.F.R. § 498.78), I decline to remand for an increase in penalty amount without Petitioner’s express agreement.  Although Petitioner was well within its rights not to support CMS’s remand request, it nevertheless shows that Petitioner wants review of the immediate jeopardy determination but does not want to potentially pay the per-day CMP amount that is required for Petitioner to gain the right to such review. 

Concerning the merits of this issue, Petitioner asserts that my analysis is backwards, i.e., that the penalty cannot impact appeal rights.  P. Response at 11-12.  However, I must follow the Secretary’s interpretation of the Social Security Act as expressed in the Secretary’s regulations.  Those regulations clearly indicate that SNF appeal rights are predicated on the enforcement remedies that CMS imposes. 

The regulations state that: “A facility may appeal a certification of noncompliance leading to an enforcement remedy.” 42 C.F.R. § 488.408(g)(1) (emphasis added).  This is consistent with the list of appealable initial determinations, which includes: “the finding of noncompliance leading to the imposition of enforcement actions specified in § 488.406 . . . .” 42 C.F.R. § 498.3(b)(13) (emphasis added).  These regulations are both consistent with the certification of noncompliance regulation that states: “The provisions of part 498 of this chapter apply when [SNFs] request a hearing on a denial of participation, or certification of noncompliance leading to an enforcement remedy.” 42 C.F.R. § 488.330(e)(iii) (emphasis added).  In all of these regulations, the right to appeal is not based solely on a finding of noncompliance, but on noncompliance that results in the imposition of a sanction. 

Case decisions from the Departmental Appeals Board have long interpreted these regulations to preclude SNFs from appealing CMS findings of noncompliance when CMS does not impose an enforcement remedy.  This is true even if CMS imposes an enforcement remedy but rescinds the imposition of the remedy.  Columbus Park, DAB

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No. 2316 at 7 (2010).  If CMS does not impose a remedy or rescinds the imposition of a remedy, then an SNF has no right to a hearing even if its Five-Star Rating is affected.  Generations at Regency Ctr., DAB No. 2950 at 6-7 (2019).  Therefore, it is clear that the right to a hearing for SNFs is inextricably connected to the enforcement remedy that CMS imposes. 

In the present case, CMS did impose a remedy.  CMS had the option of imposing a per-instance CMP or a per-day CMP.  42 C.F.R. § 488.438(a).  If CMS imposed a per-instance CMP, then CMS would pick an amount of money for the penalty within a single range.  For example, the original per-instance CMP range before inflation adjustments was between $1,000 and $10,000.  42 C.F.R. § 488.438(a)(2).  However, in the present case, CMS decided to impose a per-day CMP, which meant that there were two ranges of penalty amounts from which CMS could impose a penalty.  If CMS determined that Petitioner’s noncompliance immediately jeopardized the health and safety of residents, then CMS could impose a per-day CMP from the upper range of dollar amounts.  42 C.F.R. § 488.438(a)(1)(i).  However, noncompliance that did not immediately jeopardize the health and safety of residents only permits CMS to choose a per-day CMP amount from the lower range of dollar amounts.  42 C.F.R. § 488.438(a)(1)(ii). 

As explained in my April 14 Order, CMS imposed a per-day CMP amount in the lower range.  This is the range where CMS need not have found that Petitioner immediately jeopardized the health and safety of residents. 

Petitioner wants me to review whether CMS’s immediate jeopardy determination in this case was correct.  However, the regulations expressly state that an action by CMS that is not an initial determination “and therefore not subject to appeal” includes “[t]he finding that the [SNF’s] deficiencies pose immediate jeopardy to the health and safety of residents.” 42 C.F.R. § 498.3(d)(10)(i).  There is an exception to this prohibition because an appealable initial determination can be “[t]he level of noncompliance found by CMS in an SNF . . . but only if a successful challenge on this issue would affect . . . [t]he range of civil money penalty amounts that CMS could collect . . . .” 42 C.F.R. § 498.3(b)(14)(i) (emphasis added). 

Based on the regulations above, the Departmental Appeals Board has decided that, even if CMS finds immediate jeopardy and imposes a per-instance CMP on an SNF, the SNF has no right to appeal the immediate jeopardy determination because there is only one range of penalties.  Fort Madison Health Ctr., DAB No. 2403 at 12 (2011) (“[T]he net effect of all these regulations is that challenges to the scope and severity are limited to only situations where the determination of immediate jeopardy results in a higher range of CMP . . . .”).  Again, the remedy imposed determines the right to review. 

In the present case, CMS imposed a CMP in the lower range for per-day CMPs.  If I were to review the immediate jeopardy determination in this case and find it clearly erroneous,

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this would not result in a change in the range of penalties because CMS already imposed a penalty amount from the lower range.  In essence, CMS could have imposed the per-day CMP that it did without finding immediate jeopardy; therefore, it is unnecessary to determine whether the immediate jeopardy finding was clearly erroneous to uphold the CMP.  In fact, it is not only unnecessary, but improper for me to do so under 42 C.F.R. § 498.3(d)(10)(i).  

Finally, I note that Petitioner states that CMS’s immediate jeopardy determination is always appealable.  However, this is simply false.  As stated above, the imposition of per-instance CMPs do not result in review of an immediate jeopardy determination.  This is entirely consistent with the controlling statute.  Related to SNFs, the terms “immediate jeopardy,” “immediately jeopardize,” and “immediate jeopardizes” only appear in subsection (h) of 42 U.S.C. § 1395i-3.  Subsection (h) is entitled “Enforcement Process,” and only deals with enforcement remedies.  In subsection (h), a finding of immediate jeopardy requires the Secretary to take immediate action to remove the jeopardy and correct the deficiencies and specifies that the Secretary will either appoint temporary management for the SNF or terminate the SNF from participation in the Medicare program.  42 U.S.C. § 1395i-3(h)(2)(A)(i), (2)(B)(iii), (4).  Significantly, concerning the imposition of a CMP, subsection (h) does not distinguish between an immediate jeopardy deficiency and a non-immediate jeopardy deficiency.  42 U.S.C. § 1395i-3(h)(2)(A)(i), (B)(ii)(I).  Therefore, while the Secretary decided to create, by regulation, a higher CMP range for immediate jeopardy deficiencies and a lower one for non-immediate jeopardy deficiencies, the statute does not require this.  There is no reason to conclude that the statute makes an immediate jeopardy determination appealable when a CMP is imposed. 

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

The SOD alleges noncompliance with 42 C.F.R. § 483.80(a)(1)-(2) because Petitioner failed to implement its IPCP.  However, the factual allegations in the SOD can be broadly divided into two groups:  1) screening facility staff entering on shift from mid-March 2020 to mid-May 2020; and 2) individual staff use of PPE during the May 14-18, 2020 survey.  While all of the factual allegations are related to Petitioner’s implementation of its IPCP, I will first discuss the facts and law concerning the staff screening allegations and then separately discuss the facts and law concerning staff PPE use allegations.  Further, the first Finding of Fact/Conclusion of Law below discusses Petitioner’s objections to 42 C.F.R. § 483.80(a)(1)-(2).  It is necessary to discuss the objection first because the explanation provides the legal framework for how I will decide the alleged deficiency in this case. 

1. The alleged deficiency in this case is that Petitioner failed to maintain (i.e., fully implement) its IPCP.  This requirement for SNFs is statutory.  Therefore, Petitioner’s arguments as to why the Secretary’s infectious disease control regulation is improperly written and/or applied are incorrect. 

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Petitioner provides no support for the argument that Congress did not contemplate the possibility of a pandemic when establishing the requirement that SNFs establish and maintain infectious disease control programs. 

In this case, CMS concluded that Petitioner was not in substantial compliance with 42 C.F.R. § 483.80(a)(1)-(2), which provides that an SNF “must establish and maintain an [IPCP]” with certain enumerated “elements.” One of those “elements” is that the IPCP must have: 

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. 

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

Petitioner argues that COVID-19 presented, in the first few months of the pandemic, a chaotic situation in which “the CDC [Centers for Disease Control and Prevention] and CMS issued multiple vague, contradictory and even impossible-to-implement ‘interim guidance’ documents during the Spring of 2020 – and facilities such as [Petitioner] scrambled to incorporate such ‘guidance’ into practical policies, staff training, and procedures,” which did not permit SNFs to establish a COVID-19 IPCP in an orderly way.  P. Br. at 19.  Petitioner then appears to question whether it can be held responsible for failing to implement provisions of its IPCP that provided more stringent requirements than CDC did in guidelines.  P. Br. at 20.  However, Petitioner answers its own question by asserting that, should an SNF adopt provisions in an IPCP that, if not implemented, would not plausibly pose the potential for more than minimal harm, then the SNF cannot be found noncompliant with 42 C.F.R. § 483.80(a).  P. Br. at 20.  Further, Petitioner asserts that the CDC’s 2007 infectious disease control guidelines, which were still followed at the beginning of the COVID-19 pandemic, were symptom based and that the CDC has acknowledged the asymptomatic transmission of COVID-19.  P. Br. at 20.  Further, Petitioner states that CDC modified its approach to infectious disease control to accommodate a variety of issues posed by the pandemic, such as the retention of infected residents rather than discharging them and the extended use of PPE due to shortages of PPE.  P. Br. at 21. 

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From this background, Petitioner argues that CMS’s position, that Petitioner needed to comply with all the provisions of its IPCP as if they were regulatory requirements, “is at best overbroad; but as applied to this case, the argument is logically backward.” P. Br. at 21.  Petitioner asserts that 42 C.F.R. § 483.80(a)(1)-(2) only provide for a few specific general requirements for the IPCP and does not address specific questions and “logistics,” such as when or how to implement droplet precautions or whether staff may temporarily remove a mask.  P. Br. at 21-22.  Petitioner then assails the regulation as being an impermissible “ad hoc” application of a broadly worded regulation in new circumstances that CMS had not foreseen.  P. Br. at 22 (citing Kisor v. Wilkie, 139 S. Ct. 2400, 2424-2425 (2019); Azar v. Allina Health Servs., 139 S. Ct. 1804, 1810-1813 (2019)).  Petitioner also attacks the regulation as inconsistent with regulations adopted by the Secretary as violating the principle that CMS may only enforce rules that have been publicly stated.  P. Br. at 22.  Petitioner concludes that, when “CMS issues broadly worded regulations, it may not impose sanctions without providing reasonably specific prior notice that it will do so if the facility fails to implement the regulation in a certain way.” P. Br. at 24. 

Based on Petitioner’s interpretation of the general guidance that CMS issued to state agency surveyors concerning 42 C.F.R. § 483.80, Petitioner believes that “CMS never contemplated application of the regulation to every aspect of a facility’s efforts to implement emergency responses to the sorts of challenges COVID-19 posed during the Spring of 2020.” P. Br. at 25.  Petitioner admits that noncompliance with clear standards cannot be excused but that there were no clear or accepted COVID-19 specific standards at the time of the survey in this case.  P. Br. at 26.  Petitioner also puzzles at CMS’s filings, which lack citation to CDC, state health agency, or CMS guidance documents, “or whether, when, or how it notified nursing facilities that they could be sanctioned for not meeting any such ‘guidance.’” P. Br. at 28.  Petitioner is quick to note that “[t]his is not to say that [Petitioner’s] policies and procedures are completely irrelevant to the analysis; in fact, they are useful, if only as measures of how [Petitioner] actually was scrambling to translate the changing CDC and CMS guidance to practical procedures and staff training on an ongoing basis during the Spring of 2020.” P. Br. at 28. 

Petitioner’s argument is incorrect.  

As a preliminary matter, most of Petitioner’s argument fails because it is directed at undermining the legitimacy of 42 C.F.R. § 483.80(a)(1)-(2) based on case law and other principles concerning regulations or policies that have a limited statutory basis and involve agency rulemaking.  However, in the present case, the operative text that serves as the basis for the deficiency, i.e., Petitioner must implement its IPCP, is statutory. 

The Act states: 

A skilled nursing facility must—

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(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).  Because this requirement is a statutory requirement, Petitioner’s arguments related to improper overreach of agency regulations are inapposite.  Even if the Secretary had not promulgated § 483.80, the Act would serve as sufficient legal basis for the Secretary to impose enforcement remedies on Petitioner for failing to maintain, i.e., implement, all of the provisions of its IPCP.  42 U.S.C. § 1395i-3(h)(2)(A). 

Because the infection control program requirement is statutory, the Secretary correctly republished the statutory requirement as the main substantive provision in § 483.80.  The Secretary then utilized other statutory authority to promulgate regulatory requirements as to general subjects that an SNF’s IPCP needs to cover.  42 U.S.C. §§ 1395i-3(c)(1)(xi), (f), 1395i-3(d)(4)(B), (f)(1); 42 C.F.R. § 483.80(a)(1)-(2).  Petitioner criticizes CMS for failing to provide substantive infection control requirements by regulation and for seeking to hold Petitioner accountable to implement its IPCP.  However, if the Secretary sought to promulgate a regulation with substantive infection control requirements, that regulation would contradict the statute, which gives SNFs, and not the Secretary, the authority and duty to establish an infection control program designed to provide a safe, sanitary, and comfortable environment and that helps prevent the development and transmission of disease and infection.  Golden Living Ctr. – Superior, DAB No. 2768 at 22-23 (rejecting the argument that the regulation failed to establish the clinical standards that SNF staff needed to meet for infection control as contrary to Congressional intent).  The Secretary has carefully promulgated regulations within authority granted by statute. 

There is some irony in Petitioner’s argument that CMS should not be able to enforce the IPCP that Petitioner created because doing so is unfair or improper.  Many would think it advantageous for a regulated entity to have control of making the rules that the entity must follow, albeit within the general framework of following national standards.  81 Fed. Reg. 68,688, 68,808 (Oct. 4, 2016) (SNFs were not required to adopt CDC guidelines).⁹   

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As indicated above, Petitioner points out that COVID-19 was an unusual situation where SNFs needed to formulate IPCPs in response to a virus that was highly contagious and included asymptomatic transmission.  One of Petitioner’s expert witnesses, Dr. Katz, testified that “[n]ursing home administrators were left to piece together a puzzle of varying recommendations while continuously scrambling to acquire PPE and staff their facilities, not to mention perform resident care.” P. Ex. 54 at 6.  Dr. Grabowski, Petitioner’s health policy expert, testified that evolving and inconsistent guidance from CDC and CMS made it difficult for nursing facilities to address admissions, testing, staffing, and acquisition and use of PPE on a consistent basis.  P. Ex. 53 at 5. 

Contrary to counsel for Petitioner’s arguments and the expert witness testimony described above, the record shows that Petitioner was able to continually update its IPCP during the first few months of the pandemic to stay up to date with evolving standards to control transmission of COVID-19.  Petitioner’s Administrator testified that its policies related to COVID-19 were not made up by his staff as the situation changed but were based on information and assistance from Petitioner’s parent company, Life Care Centers of America.  Tr. I at 200.  The corporate level made the policies and procedures, “which has a huge team” working with CDC.  Tr. I at 201.  The Administrator further testified that “[t]here would be conference calls as well where we would review any updates, and that information was going to be pushed on to our department heads to . . . get it out to the staff as quickly as possible, to try to keep people as up to date on this information.” Tr. I at 201-202.  The efficiency with which Life Care Centers would update the IPCP is clear from the fact that it first created the COVID-19 portion of its IPCP on March 10, 2020, and revised the IPCP numerous times from that date through May 7, 2020.  P. Ex. 22 at 1; P. Exs. 23-33; CMS Ex. 2 at 12-46. 

CMS takes no issue with the contents of Petitioner’s IPCP.  Tr. I at 80.  CMS alleges noncompliance with § 483.80(a)(1)-(2) because Petitioner’s staff did not always fully maintain/implement the IPCP adopted by Petitioner. 

While I reject Petitioner’s arguments summarized above, I agree with Petitioner that any failure on its part to fully implement provisions of the IPCP must rise to the level of creating a potential for more than minimal harm to residents.  Therefore, this decision focuses on evaluating the record to determine if there is sufficient evidence that Petitioner’s staff failed to implement all of Petitioner’s IPCP and, if so, whether those failures presented the potential for causing more than minimal harm to residents. 

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Screening of Petitioner’s Staff for Fever and Respiratory Infection Symptoms

2. The CDC, CMS, and the Missouri Department of Health and Senior Services notified health care providers from January to March 2020 of the infectious nature of COVID-19 and the symptoms that individuals may manifest who have COVID-19.  By mid-March 2020, Missouri had its first confirmed case of COVID-19 and the governor declared a state of emergency. 

The first outbreak of COVID-19 occurred in the People’s Republic of China in December 2019.  P. Ex. 1 at 1.  On January 17, 2020, CDC issued an update on COVID-19 stating that individuals should be treated as patients under investigation in the United States if they have fever or 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 confirmed by laboratory testing to have COVID-19.  P. Ex. 1 at 2. 

On January 22, 2020, the Missouri Department of Health and Senior Services provided “Recent News” concerning COVID-19, in which it indicated that much was still unclear about COVID-19; however, it is thought that person-to-person spread of the virus can occur through respiratory droplets with close contact and symptoms associated with COVID-19 “have included fever, cough, and trouble breathing.” P. Ex. 2 at 1.  A January 27, 2020 “Recent News” statement indicated that five confirmed COVID-19 cases were in the United States and more than 100 active investigations across the country were occurring.  P. Ex. 3 at 1. 

A February 1, 2020 CDC Health Update indicated that 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. 4 at 1-2.  CDC suggested that clinicians ask patients if they have fever or symptoms of lower respiratory infection, such as cough or shortness of breath, and whether the patient had close contact with a person confirmed with a COVID-19 infection.  P. Ex. 4 at 2. 

On February 6, 2020, CMS issued a memorandum on “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. 5 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. 5 at 2. 

As of February 10, 2020, the Missouri Department of Health and Senior Services provided “Recent News” that COVID-19 “is showing the ability to spread as easily as the

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flu” and that “steps [taken] to prevent the spread of flu and the common cold could also help prevent the spread of other respiratory viruses like [COVID-19].” P. Ex. 6 at 2.  A February 28, 2020 “Recent News” stated that there had yet to be confirmed cases of COVID-19 in Missouri.  P. Ex. 7 at 2. 

On March 13, 2020, the Governor of Missouri issued an Executive Order declaring a State of Emergency because:  as of March 7, 2020, the first case of COVID-19 had been identified in Missouri and, at the time of the Executive Order, there were additional confirmed or presumptively COVID-19 positive individuals in the state; COVID-19 can result in mild or severe symptoms, is highly contagious, and is spread through close contact between persons and respiratory transmission; and the identification of additional COVID-19 positive cases is likely to continue, and steps should be taken to prevent a substantial risk to public health and safety.  CMS Ex. 26 at 1; P. Ex. 8.  The State of Emergency was eventually extended through at least the end of 2020.  CMS Ex. 26. 

3. Residents in SNFs were highly vulnerable to COVID-19 due to the general weakened health of many residents, the need for many residents to receive personal care from staff, and the design of most SNFs physical facilities that included communal living but failed to have negative air pressure exchange rooms.  

The COVID-19 pandemic presented a difficult and dangerous situation for all.  However, as discussed below, residents in SNFs were particularly at risk for acquiring COVID-19.  This was especially true at the beginning of the pandemic before rapid COVID-19 testing became available. 

One of Petitioner’s expert witnesses, David Grabowski, Ph.D., is a professor of health care policy.  He testified that neither the long-term care system as a whole nor individual facilities were sufficiently resourced to address a sudden clinical crisis.  Dr. Grabowski stated that the traditional symptom-based infection control practice CMS required was rendered ineffective due to the extreme contagiousness of COVID-19 and its spread by asymptomatic persons.  A lack of testing and rapid testing frustrated efforts to effectively segregate or cohort infected and uninfected residents.  He also blamed “obsolete physical plants” and “obsolete air handling systems.” P. Ex. 53 at 3.  Dr. Grabowski testified that his research indicated that the strongest predictor for whether COVID-19 cases would appear in SNFs was the “community spread” of the virus.  P. Ex. 53 at 4.  Further, his research indicated that COVID-19 could spread rapidly: 

Research by my team, and also by colleagues at Johns Hopkins, has further demonstrated that even a single infected resident or staff member can spread the virus through a nursing or assisted living facility within days. 

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P. Ex. 53 at 4. 

One of Petitioner’s medical experts, Dr. Katz, testified that her research showed that COVID-19 would pose significant risks to SNFs because:  1) the resident population is highly vulnerable and suffers the worst outcomes from this disease; 2) residents require close personal care from staff; and 3) residents reside in structures meant for group living.  P. Ex. 54 at 2-3.  Dr. Katz testified that these three factors placed even SNFs with impeccable infection prevention practices at particular risk.  P. Ex. 54 at 3.  Dr. Katz also testified that approximately 40% of individuals may carry COVID-19 and be both asymptomatic and able to transmit it to others.  P. Ex. 54 at 3.  She also said the following: “To be clear:  if a nursing home does not have the capacity to identify cases and isolate them appropriately, infection prevention practices, even if performed perfectly, will be inadequate.” P. Ex. 54 at 5. 

Regarding Petitioner’s facility, Petitioner’s Administrator and Medical Director testified that they were not able to fully implement CDC guidelines due to the physical plant features of the facility.  They testified that as early as February 6, 2020, the CDC advised all health care facilities to implement contact, droplet, and airborne precautions from CDC’s 2007 Infection Control Guidelines.  However, they testified that airborne precautions were problematic because Petitioner’s facility did not have negative pressure air exchange rooms, which are common in hospitals.  P. Ex. 47 at 3-4; P. Ex. 48 at 4; see also Tr. I at 47 (Surveyor testifying that she did not think she had ever entered an SNF that could truly satisfy the airborne transmission precautions in the CDC’s 2007 guidelines due to a lack of negative pressure rooms).  CDC previously required SNFs to transfer residents with highly infectious diseases to hospitals (Tr. I at 47); however, this would not be an option during the pandemic much of the time. 

4. Beginning no later than March 11, 2020, Petitioner’s IPCP required Petitioner to screen its staff at the beginning of their shifts.  From this time through the mid-May 2020 state agency survey, the IPCP screening was to be completed in accordance with guidance from CDC, CMS, and local and state health departments.  Beginning on April 3, 2020, Petitioner added to the IPCP an express statement that employee screening will include questions about COVID-19 symptoms and a temperature check.  Despite many revisions to the IPCP from March to May 2020, the IPCP always provided that employees with signs and symptoms of respiratory infection could not work in the Petitioner’s facility.  For most of this period, the IPCP provided that employees with respiratory infection symptoms could not return to work until such symptoms abated and at least a week or ten days (depending on the version of IPCP) passed since the symptoms were first observed or, alternately two COVID-19 tests, taken at least 24 hours apart, were negative. 

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The SOD alleged that, intermittently from March 11, 2020 through mid-May 2020, Petitioner failed to properly screen staff entering the facility for fever and signs and symptoms of respiratory infection as well as permitted some employees who had a fever or signs and symptoms of respiratory infection to work at the facility.  CMS Ex. 1 at 8-9. 

From March 11, 2020 through mid-May 2020, Petitioner revised its IPCP concerning COVID-19 many times.  However, as demonstrated below, the provisions for screening facility employees for fever and respiratory infection symptoms, and the prohibition on facility employees working with fever or respiratory infection symptoms, remained essentially the same. 

The March 11, 2020 version of Petitioner’s IPCP concerning COVID-19 specified that: “All associates will be screened at the beginning of their shift in accordance with current guidance from CDC, CMS, and local and state health departments.” P. Ex. 22 at 1.  In addition, the IPCP did not allow employees with “signs and symptoms of respiratory infection” to work in the facility.  The IPCP instructed employees who noticed such signs and symptoms at home to “not report to work” and, for employees who noticed such signs and symptoms while at work, to “[i]mmediately stop work, put on a facemask, and self-isolate at home.” P. Ex. 22 at 1-2. 

The policies summarized above in the March 11, 2020 IPCP remained the same in the following revised versions of the IPCP:  March 13, 2020 (P. Ex. 23 at 2); March 20, 2020 (P. Ex. 24 at 3); and April 2, 2020 (P. Ex. 25 at 3-4).  In addition to those policies, starting with the March 20, 2020 revised IPCP, return to work provisions were added.  The IPCP indicated that, if COVID-19 testing were available, then the employee with fever or respiratory infection symptoms needed to be excluded from work until the following happened:  resolution of the fever; improvement of respiratory symptoms; and two negative COVID-19 tests taken at least 24 hours apart from each other.  P. Ex. 24 at 4.  If the employee could not be tested, then the employee was to be excluded from work until three days passed since resolution of fever and/or improvement in respiratory symptoms, and at least seven days had passed since symptoms first appeared.  P. Ex. 24 at 4. 

In Petitioner’s revised April 3, 2020 IPCP, Petitioner continued to require the screening of all employees at the beginning of their shifts in accordance with current guidance from CDC, CMS, and local and state health departments.  However, the IPCP now explicitly added that “[t]his screening will include questions about COVID-19 symptoms and a temperature check.” P. Ex. 26 at 4.  The IPCP continued to require employees not to report to work if they noticed signs or symptoms of respiratory infection and, if they came to work and then noticed such symptoms, to immediately stop work and isolate at home.  P. Ex. 26 at 3-4.  The IPCP continued to provide the same rules, as described in the March 20, 2020 IPCP above, for returning to work after manifesting symptoms.  P. Ex. 26 at 5. 

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The policies summarized above for the revised April 3, 2020 IPCP remained the same for the April 13, 2020 (P. Ex. 27 at 3-5) and April 15, 2020 (P. Ex. 28 at 4, 6-7) revised versions of the IPCP. 

Starting with the revised IPCP on April 20, 2020, employees who experienced signs or symptoms of a respiratory infection while at work were to immediately stop working and to keep a mask on but were no longer explicitly directed to isolate at home.  P. Ex. 29 at 7.  The April 20, 2020 revision did not change the policies that all employees are to be screened at the beginning of each shift for fever and respiratory symptoms, that employees with respiratory symptoms were not to come to work, or that employees must meet certain requirements to return to work after having fever or symptoms.  P. Ex. 29 at 5, 8. 

Revisions to the IPCP for COVID-19 on April 27, 2020 (P. Ex. 30 at 5, 6, 8-9) and April 29, 2020 (P. Ex. 31 at 7-10) did not change the provisions described above in the April 20, 2020 version of the IPCP.  The revised May 6, 2020 IPCP also kept most of the provisions described above in the April 20, 2020 version of the IPCP.  P. Ex. 32 at 9, 11-12.  However, the revised May 6, 2020 IPCP modified the provision for returning to work, requiring that an employee who had symptoms to wait until ten days had passed since symptoms first appeared (so long as it had been three days since the employee had recovered from those symptoms).  P. Ex. 32 at 12. 

The May 7 and 13, 2020 revised IPCPs were unchanged regarding the provisions described above in the May 6, 2020 revised IPCP.  CMS Ex. 2 at 21-22, 24-25; P. Ex. 33 at 10-11, 13-14 (May 7, 2020). 

5. On March 13, 2020, CMS issued a guidance document on infection control and prevention for SNFs concerning COVID-19 that recommended screening staff at the beginning of their shifts for fever and respiratory symptoms.  On April 13, 2020, CDC issued updated infection control guidance for healthcare facilities that recommended screening all employees at the beginning of their shift for fever (defined as greater than or equal to 100.0° Fahrenheit (F)) and various respiratory infection symptoms.  Both guidance documents recommended that facilities document even the absence of symptoms when screening employees.  Both documents recommended that staff with symptoms should leave the workplace. 

The record contains two guidance documents that provide recommendations concerning staff screening.  They are substantially similar in their recommendations.  

On March 13, 2020, CMS issued a document concerning “Guidance for Infection Control and Prevention of Coronavirus Disease 2019 (COVID-19) in Nursing Homes (REVISED).” This document stated that “For ALL facilities nationwide,” SNFs should

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restrict visitation of all visitors and non-essential health care personnel.  P. Ex. 10 at 2.  CMS also stated, under the title of “Additional guidance,” that SNFs should “[i]mplement active screening of residents and staff for fever and respiratory symptoms.” P. Ex. 10 at 3.  This guidance continued as follows: 

Screen all staff at the beginning of their shift for fever and respiratory symptoms.  Actively take their temperature and document absence of shortness of breath, new or change in cough, and sore throat.  If they are ill, have them put on a facemask and self-isolate at home. 

P. Ex. 10 at 3. 

On April 13, 2020, CDC issued an updated COVID-19 guidance document, titled “Interim Infection Prevention and Control Recommendations for Patients with Suspected or Confirmed Coronavirus Disease 2019 (COVID-19) in Healthcare Settings,” which stated:  

Screen all [healthcare personnel] at the beginning of their shift for fever and symptoms consistent with COVID-19[.] 

Actively take their temperature and document absence of symptoms consistent with COVID-19.  If they are ill, have them keep their cloth face covering or facemask on and leave the workplace. 

Fever is either measured temperature ≥100.0°F or subjective fever.  Note that fever may be intermittent or may not be present in some individuals, such as those who are elderly, immunosuppressed, or taking certain medications (e.g., NSAIDs).  Clinical judgment should be used to guide testing of individuals in such situations.  Respiratory symptoms consistent with COVID-19 are cough, shortness of breath, and sore throat.  Medical evaluation may be warranted for lower temperatures (<100.0°F) or other symptoms (e.g., muscle aches, nausea, vomiting, diarrhea, abdominal pain, headache, runny nose, fatigue) based on assessment by occupational health.  Additional information about clinical presentation of patients with COVID-19 is available. 

P. Ex. 15 at 9. 

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6. Petitioner commenced screening staff at the beginning of their shifts for fever and symptoms of respiratory infection on March 11, 2020.  Petitioner recorded the results of the screening on forms that the facility created for that purpose.  However, from March 11, 2020 through May 11, 2020, many screening forms had entries for employees who appeared for their shifts but were not completed as to temperature and/or respiratory symptoms.  Further, in one instance, an employee with a temperature of 100.3°F was permitted to work even though the screening form specified that all individuals with a temperature of 100.0°F or more were not allowed to work at the facility.  Other forms document signs or symptoms of respiratory infection for employees who were allowed to work at the facility, even though the screening form and/or IPCP indicated that such symptoms should result in the staff member not being permitted to do so.  There is no documentation in the record showing that Petitioner’s medical staff individually evaluated each instance where a staff member had fever or signs and symptoms of respiratory infection and determined that the staff member was safe to work in the facility. 

On March 11, 2020, Petitioner began to screen all staff for fever and for any cold or flu symptoms at the beginning of their shifts.  P. Ex. 47 at 6; P. Ex. 48 at 7; P. Ex. 50 at 2-3.  Until the end of March 2020, Petitioner’s department heads conducted the screenings, after which time the screenings were conducted at the front desk of the facility.  P. Ex. 47 at 6; P. Ex. 48 at 7.  Petitioner’s Administrator testified that screenings were initiated prior to CMS’s recommendation to conduct screenings on March 13, 2020.  P. Ex. 47 at 7. 

March 11, 2020 Screenings

The screening sheet for March 11, 2020, is a grid in which staff names are listed in the left column and then to the right are columns to indicate if there is:  fever (>100.4); cough; shortness of breath; body aches; and sore throat.  The form shows the names for 17 employees.  Only four boxes on the entire form are checked for symptoms.  There is no indication that this form was meant to capture negative responses related to symptoms.  The form shows the following:  S.M. reported body aches; S.H. and T.H. reported sore throats; and J.R. reported shortness of breath.  CMS Ex. 4 at 1; P. Ex. 37 at 1. 

S.M. (designated by CMS as Employee 7) worked from 6:43 a.m. until 5:03 p.m. on March 11, 2020.  CMS Ex. 4 at 7.  T.H. (designated by CMS as Employee 9) worked from 6:37 a.m. to 2:40 p.m. on March 11, 2020.  CMS Ex. 4 at 10.  J.R. (designated by CMS as Employee 10) worked from 2:41 p.m. to 10:19 p.m. on March 11, 2020.  CMS Ex. 4 at 12.  It is not clear if S.H. worked on March 11, 2020.  

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In mid-June 2020, or more than three months later, Petitioner obtained a statement from S.M. that the report of body aches on the screening sheet was due to lower back pain and some knee aches.  P. Ex. 38 at 1.  In mid-June 2020, the Director of Nursing (DON) spoke with S.H. by phone, and S.H. allegedly stated that she had a sore throat but did not have a temperature.  The DON also spoke with T.H. in mid-June 2020, and T.H. allegedly stated that she had a “regular sore throat” and not a fever.  The DON was not able to get J.R. on the telephone.  P. Ex. 38 at 2. 

The March 11, 2020 version of Petitioner’s IPCP concerning COVID-19 specified that: “All associates will be screened at the beginning of their shift in accordance with current guidance from CDC, CMS, and local and state health departments.” P. Ex. 22 at 1.  In addition, the IPCP did not allow employees with “signs and symptoms of respiratory infection” to work in the facility.  The IPCP instructed employees who noticed such signs and symptoms at home to “not report to work” and, for employees who noticed such signs and symptoms while at work, to “[i]mmediately stop work, put on a facemask, and self-isolate at home.” P. Ex. 22 at 1-2. 

The SOD alleged the following: 

On 3/11/2020, the facility failed to thoroughly screen 17 staff, one of which reported body aches, two reported sore throats, and one reported shortness of breath.  None of the 17 staff had documented temperatures. 

CMS Ex. 1 at 8. 

I find that Petitioner failed to maintain/implement that March 11, 2020 IPCP.  Although the IPCP references CMS and CDC guidelines, there are none in the record covering that date.  Despite this, it is clear from the IPCP that staff were to be screened for fever and respiratory infection symptoms and that the manifestation of any such symptoms meant that the staff member was to leave the facility and return home.  In the present case, at least three of the four employees who presented with symptoms were allowed to work on March 11, 2020 despite having symptoms.  Even if S.M.’s body aches were caused by another reason, Petitioner still permitted at least two individuals with respiratory symptoms to work that day. 

I do not find that, as indicated in the SOD, that all 17 employees were not screened on March 11, 2020.  The screening form appears to only require documentation of a temperature above 100.4°F or symptoms when they occurred.  The March 11, 2020 screening occurred before CMS issued guidance, which recommended facilities to note even the absence of symptoms of COVID-19 when screening employees.  

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March 12-16, 2020 Screenings

Petitioner significantly revised its screening sheet on March 11, 2020, which was used for the staff screenings relevant to this case (i.e., through at least May 11, 2020).  The revised sheet again listed the employee’s name in one column, with several columns to the right of the name that needed to be completed.  Most relevant to this case, one column indicates that a “Y” or an “N” be placed in a column with the word “Fever” at the top.  In the next column to the right of the “Fever” column is a column titled “Temp.” This column includes a reference to note 1 at the bottom of the sheet, which specifies that: “Fever = temp of >100.0 = if present send associate home.” The next column to the right is titled “S/S of Resp Infection (cough, sore throat, SOB).” This column also indicates either a “Y” or “N” must be entered.  Further, this column references note 2 at the bottom of the sheet, which specifies that:  S/S of Resp Infection = cough, sore throat, shortness of breath = if present send associate home and advise to see primary health provider.” The form also provides the following instructions:  “If an associate becomes sick while at work, the associate should self-isolate, put on a facemask, report illness to direct supervisor, and go home.” CMS Ex. 12 at 2 (emphasis omitted). 

On a screening sheet, there is an entry for March 13, 2020, where the temperature for one employee is not recorded.  CMS Ex. 12 at 1.  On another screening sheet, there is another entry for March 13, 2020, in which there is no “Y” or “N” for the column to record COVID-19 symptoms.  CMS Ex. 12 at 2.  On an additional screening sheet for ten employees screened between March 13 and 15, 2020, the screening sheet only provides screening information as to temperature/fever but fails to indicate “Y” or “N” for any of the columns concerning COVID-19 symptoms.  CMS Ex. 12 at 3.  On a screening sheet that included entries for March 16, 2020, there is no information recorded for two employees (i.e., no temperature and no “Y” or “N” entered in the Fever column and the Signs and Symptoms of COVID-19 column).  CMS Ex. 12 at 4.  Another screening sheet for March 16, 2020, includes temperatures for four employees, but no indication of “Y” or “N” as to COVID-19 symptoms.  CMS Ex. 12 at 5. 

Petitioner’s IPCP in effect from March 12-16, 2020 required the screening of Petitioner’s staff at the beginning of each shift and that the screening would follow the guidance issued by CMS and CDC.  P. Ex. 23 at 2.  On March 13, 2020, CMS issued guidance recommending screening of employees for fever and symptoms of respiratory infection.  CMS indicated that facilities should document when there were no symptoms.  P. Ex. 10 at 3. 

The SOD alleged that Petitioner “failed to thoroughly screen staff for COVID-19 prior to caring for residents in the facility.” CMS Ex. 1 at 3.  The screening sheets discussed above show a number of instances where there is no evidence that Petitioner properly screened employees as they entered on their new shift.  Therefore, I find that these screening sheets show that Petitioner failed to maintain/implement its IPCP.

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March 17-19, 2020 Screenings

On a screening sheet with dates ranging from March 17 to March 19, 2020, there are seven instances where there is no “Y” or “N” in the column for symptoms of COVID-19.  CMS Ex. 5 at 1; P. Ex. 37 at 14.  Facility records indicate that two of the employees, T.S. (designated by CMS as Employee 13) and M.W. (designated by CMS as Employee 14), worked on March 17 and 19, 2020, for approximately eight hours each day.  CMS Ex. 5 at 2-3.  Petitioner submitted statements from T.S. and M.W. that neither have ever had COVID-19 symptoms.  P. Ex. 38 at 3-4, 16. 

As stated above, Petitioner’s IPCP required that employees be screened for fever and COVID-19 symptoms and that this would be done in accordance with CDC and CMS guidance.  Also as stated above, CMS guidance recommended screening that would document even negative findings as to symptoms. 

The SOD alleged that Petitioner “failed to thoroughly screen staff for COVID-19 prior to
caring for residents in the facility.” CMS Ex. 1 at 3.  Further, the SOD alleged the following: 

On 3/17/2020, the facility failed to thoroughly screen two staff, who had temperatures taken, but failed to answer any screening questions. 

CMS Ex. 1 at 8. 

The screening sheets discussed above show a number of instances where there is no evidence that Petitioner properly screened employees as they entered on their new shift.  The statements from T.S. and M.W. confirm this by referring to the portions of the screening sheet “left blank.” P. Ex. 38 at 3-4, 16.  Therefore, I find that these screening sheets show that Petitioner failed to maintain/implement its IPCP. 

March 25, 2020 Screenings

On a screening sheet for March 25, 2020, entries for four employees have neither a “Y” nor “N” in the column for COVID-19 symptoms.  Further, one of those four employees also had 100.3°F listed as that employee’s temperature.  The employees were L.S. (designated by CMS as Employee 15), D.H. (designated by CMS as Employee 16), M.F. (designated by CMS as Employee 18), and C.B. (designated by CMS as Petitioner’s DON).  CMS Ex. 6 at 1; P. Ex. 37 at 9.  Facility records indicate that these four employees worked approximately eight to nine hours on March 25, 2020.  CMS Ex. 6 at 3-4, 6-7.  Petitioner submitted statements from L.S. and D.H. that neither have ever had COVID-19 symptoms.  P. Ex. 38 at 5-6, 17. 

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As stated above, Petitioner’s IPCP required that employees be screened for fever and COVID-19 symptoms and that this would be done in accordance with CDC and CMS guidance.  Also as stated above, CMS guidance recommended screening that would document even negative findings as to symptoms. 

The SOD alleged that Petitioner “failed to thoroughly screen staff for COVID-19 prior to caring for residents in the facility.” CMS Ex. 1 at 3.  Further, the SOD alleged the following: 

On 3/25/2020, the facility failed to thoroughly screen six staff reporting for work, when the staff failed to answer screening questions.  Additionally, the DON reported a temperature of 100.3F, and failed to answer any screening questions.  Time clock records documented that the DON worked her scheduled shift that day. 

CMS Ex. 1 at 8. 

The screening sheets discussed above show a number of instances where there is no evidence that Petitioner properly screened employees as they entered on their new shift.  The statements from L.S. and D.H. confirm this by referring to the portions of the screening sheet “left blank.” P. Ex. 38 at 5-6, 17.  Therefore, I find that these screening sheets show that Petitioner failed to maintain/implement its IPCP. 

Further, the DON’s temperature of 100.3°F has raised the issue as to whether that temperature should have resulted in the DON leaving the facility rather than work.  As discussed earlier, Petitioner’s COVID-19 staff screening form in effect for the March 11, 2020 screenings indicated that an employee only had a fever if it the temperature was over 100.4°F.  That screening form was revised on March 11, 2020, and the form defined a fever as greater than 100.0°F. 

Two of Petitioner’s witnesses testified that, based on CDC guidance from April 2020, Petitioner changed the standard for fever to a temperature of 100.0°F.  P. Ex. 47 at 6; P. Ex. 48 at 7.  CDC’s April 13, 2020 revised guidance indicates that 100.0°F is the standard for screening for fever for COVID-19.  P. Ex. 15 at 9. 

In this case, there was testimony on the clinical definition of fever.  Petitioner’s medical director testified that the temperature at which there is generally considered to be a fever is 101 or 101.5°F.  Tr. II at 21.  The surveyor testified that, in the nursing field, a temperature of either 100°F or 100.4°F is considered a fever.  Tr. I at 91. 

In response to a question as to whether there is a concern in this case if Petitioner established a lower temperature for fever than CDC guidance indicated, the surveyor

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testified that a deficiency occurred because Petitioner failed to follow its own policy as to what constituted a fever.  Tr. I at 92-93.  The surveyor testified that it could be logical for the facility to set 100°F as the threshold for fever while screening staff even if CDC was, at that time, indicating that 100.4°F constituted fever.  Tr. I at 96.  The surveyor testified that if she were taking care of a resident and the resident had a 100-degree temperature, she would inform the resident’s physician that the resident had a 100-degree fever.  Tr. I at 97. 

Petitioner created the screening form.  Tr. II at 11-12.  I find that Petitioner established 100.0°F as the threshold for fever for the purpose of screening staff for COVID-19.  Petitioner changed the temperature on its screening forms from 100.4°F to 100.0°F.  CMS Ex. 4 at 1; CMS Ex. 5 at 1.  Also, the new screening form required the employee to be sent home if the temperature was greater than 100.0°F.  While it appears that CDC may not yet have lowered the temperature to determine fever when screening staff, CDC did do so shortly afterwards, indicating that Petitioner’s standard, while stricter, was certainly reasonable.  Further, Petitioner’s IPCP did not specify a temperature.  Therefore, I find that Petitioner failed to maintain/implement its IPCP when Petitioner did not comply with its requirement to send the DON home following the recording of a 100.3°F temperature. 

March 30, 2020 Screenings

On screening sheets for March 30, 2020, the temperature for one employee is not recorded and neither is there a “Y” nor “N” in the column titled Fever.  CMS Ex. 7 at 1.  Further, three other individuals do not have either a “Y” or “N” in the column concerning COVID-19 symptoms.  CMS Ex. 7 at 2-3. 

As stated above, Petitioner’s IPCP required that employees be screened for fever and COVID-19 symptoms and that this would be done in accordance with CDC and CMS guidance.  Also as stated above, CMS guidance recommended screening that would document even negative findings as to symptoms. 

The SOD alleged that Petitioner “failed to thoroughly screen staff for COVID-19 prior to caring for residents in the facility.” CMS Ex. 1 at 3.  Further, the SOD alleged the following: 

On 3/30/2020, the facility failed to thoroughly screen five staff reporting for work, when the staff failed to answer screening questions. 

CMS Ex. 1 at 8. 

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The screening sheets discussed above show a number of instances where there is no evidence that Petitioner properly screened employees as they entered on their new shift.  Therefore, I find that these screening sheets show that Petitioner failed to maintain/implement its IPCP. 

April 2, 2020 Screenings

On screening sheets for April 2, 2020, there is neither a “Y” nor “N” in the column concerning COVID-19 symptoms for three employees.  CMS Ex. 12 at 6. 

As stated above, Petitioner’s IPCP required that employees be screened for fever and COVID-19 symptoms and that this would be done in accordance with CDC and CMS guidance.  Also as stated above, CMS guidance recommended screening that would document even negative findings as to symptoms. 

The SOD alleged that Petitioner “failed to thoroughly screen staff for COVID-19 prior to caring for residents in the facility.” CMS Ex. 1 at 3.  The screening sheet discussed above shows that there is no evidence that Petitioner properly screened employees when employees were entering on a new shift.  Therefore, I find that these screening sheets show that Petitioner failed to maintain/implement its IPCP. 

April 7, 2020 Screenings

On screening sheets for April 7, 2020, entries for four employees neither have a “Y” nor “N” in the column concerning COVID-19 symptoms.  Two of these employees were L.S. (designated by CMS as Employee 15) and D.H. (designated by CMS as Employee 16).  CMS Ex. 8 at 1; P. Ex. 37 at 16.  Facility records indicate that L.S. and D.H. worked at Petitioner’s facility on April 7, 2020.  CMS Ex. 8 at 3, 6.  Petitioner submitted statements from L.S. and D.H. that neither have ever had COVID-19 symptoms.  P. Ex. 38 at 5-6, 17. 

As stated above, Petitioner’s IPCP required that employees be screened for fever and COVID-19 symptoms and that this would be done in accordance with CDC and CMS guidance.  Also as stated above, CMS guidance recommended screening that would document even negative findings as to symptoms. 

The SOD alleged that Petitioner “failed to thoroughly screen staff for COVID-19 prior to caring for residents in the facility.” CMS Ex. 1 at 3.  Further, the SOD alleged the following: 

On 4/7/2020, the facility failed to thoroughly screen four staff reporting for work, when the staff failed to answer screening questions. 

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CMS Ex. 1 at 9. 

The screening sheet discussed above shows a number of instances where there is no evidence that Petitioner properly screened employees as they entered on their new shift.  Further, the statements from L.S. and D.H. confirm this by referring to the portions of the screening sheet “left blank.” P. Ex. 38 at 5-6, 17.  Therefore, I find that these screening sheets show that Petitioner failed to maintain/implement its IPCP. 

April 8-13, 2020 Screenings

On a screening sheet, there are entries for two employees for April 8, 2020, where the temperatures are not recorded upon entering the facility.  Further, one of the employees with no temperature entry also does not have a “Y” or “N” entered in the column for COVID-19 symptoms.  Another employee, who had a temperature entry, also did not have a “Y” or “N” in the column for COVID-19 symptoms.  CMS Ex. 12 at 7. 

On a screening sheet for April 11, 2020, there are entries for two employees recording temperatures but not indicating a “Y” or” N” for COVID-19 symptoms.  CMS Ex. 12 at 10. 

On a screening sheet for April 13, 2020, the temperatures for two employees are not recorded (although there is an “N” in the box for each concerning fever) and one employee has neither a “Y” nor “N” concerning COVID-19 symptoms.  CMS Ex. 12 at 11.  On another April 13, 2020 screening sheet, there is neither a “Y” nor “N” as to COVID-19 symptoms for two employees.  CMS Ex. 12 at 12. 

The SOD alleged that Petitioner “failed to thoroughly screen staff for COVID-19 prior to caring for residents in the facility.” CMS Ex. 1 at 3.  The screening sheets discussed above show that there is no evidence that Petitioner properly screened multiple employees when those employees were entering on a new shift.  Therefore, I find that these screening sheets show that Petitioner failed to maintain/implement its IPCP. 

April 14, 2020 Screenings

On a screening sheet for April 14, 2020, entries for two employees neither have a “Y” nor “N” in the column concerning COVID-19 symptoms.  CMS Ex. 9 at 1.  One of the employees is A.A. (which CMS designated as Employee 26).  CMS Ex. 9 at 1; P. Ex. 39 at 1.  Facility records indicate that A.A. worked at the facility on April 14, 2020.  CMS Ex. 9 at 3. 

As stated above, Petitioner’s IPCP required that employees be screened for fever and COVID-19 symptoms and that this would be done in accordance with CDC and CMS

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guidance.  Also as stated above, CMS and CDC guidance recommended screening that would document even negative findings as to symptoms. 

The SOD alleged that Petitioner “failed to thoroughly screen staff for COVID-19 prior to caring for residents in the facility.” CMS Ex. 1 at 3.  Further, the SOD alleged the following: 

On 4/14/2020, the facility failed to thoroughly screen three staff, when the staff failed to answer screening questions. 

CMS Ex. 1 at 9. 

The screening sheet discussed above shows two instances where there is no evidence that Petitioner properly screened employees as they entered on their new shift.  Therefore, I find that these screening sheets show that Petitioner failed to maintain/implement its IPCP. 

April 15-19, 2020 Screenings

On a screening sheet, there is an entry for one employee on April 15, 2020, where there is neither a “Y” nor “N” entered in the column for COVID-19 symptoms.  CMS Ex. 12 at 13.  

On a screening sheet for April 19, 2020, there is no temperature entered for an employee where there is a “Y” entered for COVID-19 symptoms (as well as a “Y” for having had contact with a confirmed case of COVID-19).  CMS Ex. 12 at 14. 

The SOD alleged that Petitioner “failed to thoroughly screen staff for COVID-19 prior to caring for residents in the facility.” CMS Ex. 1 at 3.  The screening sheets discussed above show that there is no evidence that Petitioner properly screened two employees when those employees were entering on a new shift.  Therefore, I find that these screening sheets show that Petitioner failed to maintain/implement its IPCP. 

April 24, 2020 Screenings

A screening sheet from April 24, 2020, failed to provide temperatures for three employees and failed to record a “Y” or “N” regarding COVID-19 symptoms for four employees.  CMS Ex. 10 at 1; P. Ex. 39 at 2.  Facility records indicate that two of the employees, M.G. (designated by CMS as Employee 18) and T.L. (designated by CMS as Employee 27), worked on April 24, 2020.  CMS Ex. 10 at 2, 4.

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As stated above, Petitioner’s IPCP required that employees be screened for fever and COVID-19 symptoms and that this would be done in accordance with CDC and CMS guidance.  Also as stated above, CMS and CDC guidance recommended screening that would document even negative findings as to symptoms. 

The SOD alleged that Petitioner “failed to thoroughly screen staff for COVID-19 prior to caring for residents in the facility.” CMS Ex. 1 at 3.  Further, the SOD alleged the following: 

On 4/24/2020, the facility failed to thoroughly screen four staff, when the facility failed to ensure that two staff had their temperature taken before working and all four failed to answer screening questions. 

CMS Ex. 1 at 9. 

The screening sheet discussed above shows multiple instances where there is no evidence that Petitioner properly screened employees as they entered on their new shift.  Therefore, I find that these screening sheets show that Petitioner failed to maintain/implement its IPCP. 

April 25, 2020 to May 5, 2020 Screenings

On a screening sheet for April 25, 2020, there is neither a “Y” nor “N” concerning COVID-19 symptoms for one employee.  CMS Ex. 12 at 15. 

On a screening sheet for April 27, 2020, the sheet fails to record a temperature for three employees and fails to record a “Y” or “N” for COVID-19 symptoms for two employees (including one for which no temperature was recorded).  CMS Ex. 12 at 16.  On another screening sheet for April 27, 2020, there are neither temperatures recorded nor a “Y” or “N” concerning COVID-19 symptoms recorded for two employees.  CMS Ex. 12 at 17. 

On a screening sheet for April 28, 2020, the sheet fails to record temperatures for two employees.  The screening sheet is also missing a “Y” or “N” in the column for COVID-19 symptoms for those two employees.  CMS Ex. 12 at 18. 

On a screening sheet for April 30, 2020, the sheet fails to record temperatures for three employees.  The screening sheet is also missing a “Y” or “N” in the column for COVID-19 symptoms for one employee.  CMS Ex. 12 at 19. 

On a screening sheet for May 1, 2020, the sheet fails to record the temperature for one employee.  The screening sheet is also missing a “Y” or “N” in the column for COVID-19 symptoms for four employees.  CMS Ex. 12 at 20. 

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On a screening sheet for May 5, 2020, a “Y” or “N” is missing in the column for COVID-19 symptoms for one employee.  CMS Ex. 12 at 21. 

As stated above, Petitioner’s IPCP required that employees be screened for fever and COVID-19 symptoms and that this would be done in accordance with CDC and CMS guidance.  Also as stated above, CMS and CDC guidance recommended screening that would document even negative findings as to symptoms. 

The SOD alleged that Petitioner “failed to thoroughly screen staff for COVID-19 prior to caring for residents in the facility.” CMS Ex. 1 at 3.  The screening sheets discussed above show that there is no evidence that Petitioner properly screened multiple employees when those employees were entering on a new shift.  Therefore, I find that these screening sheets show that Petitioner failed to maintain/implement its IPCP. 

May 7, 2020 Screenings

A screening sheet from May 7, 2020, indicated that employee T.R. (designated by CMS as Employee 6) indicated that she answered yes to having symptoms of COVID-19 and to having close personal contact with a person who had a confirmed case of COVID-19.  CMS Ex. 11 at 1; P. Ex. 39 at 5.  Facility records show that T.R. worked more than eight hours at the facility on May 7, 2020.  CMS Ex. 11 at 3. 

The SOD alleged the following: 

On 5/7/2020, the facility failed to thoroughly screen all staff when a staff person had an elevated temperature of 99.4F, reported that they had signs and symptoms of COVID-19, and that they had close personal contact with a person with a confirmed case of COVID-19.  Review of the staff person's time clock records for 5/7/2020 revealed that the staff person worked from 6:28am to 3:02pm that day. 

CMS Ex. 1 at 9. 

Petitioner’s IPCP required that employees be screened for fever and COVID-19 symptoms and that this would be done in accordance with CDC and CMS guidance.  Also as stated above, CMS and CDC guidance recommended sending employees home who have symptoms of a respiratory infection.  Further, Petitioner’s IPCP states that employees who have respiratory infection symptoms should not go to work and the screening sheet also requires an employee who came to work with those symptoms to be sent home. 

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I find that Petitioner failed to maintain/implement its IPCP because it did not send T.R. home when the screening showed respiratory infection symptoms.  T.R. had been in close proximity with a confirmed case of COVID-19, making the possibility of infection more likely. 

May 10-11, 2020 Screenings

On a screening sheet for May 10, 2020, a “Y” or “N” is missing in the column for COVID-19 symptoms for two employees.  CMS Ex. 12 at 22. 

On a screening sheet for May 11, 2020, the sheet fails to record temperatures for four employees.  The screening sheet is also missing a “Y” or “N” in the column for COVID-19 symptoms for the four employees for which there are no temperatures recorded.  Further, one additional employee does not have a “Y” or “N” in the column for COVID-19 symptoms.  CMS Ex. 12 at 23. 

As stated above, Petitioner’s IPCP required that employees be screened for fever and COVID-19 symptoms and that this would be done in accordance with CDC and CMS guidance.  Also as stated above, CMS and CDC guidance recommended screening that would document even negative findings as to symptoms. 

The SOD alleged that Petitioner “failed to thoroughly screen staff for COVID-19 prior to caring for residents in the facility.” CMS Ex. 1 at 3.  The screening sheets discussed above shows that there is no evidence that Petitioner properly screened multiple employees when those employees were entering on a new shift.  Therefore, I find that these screening sheets show that Petitioner failed to maintain/implement its IPCP. 

7. Petitioner failed to be in substantial compliance with 42 U.S.C. § 1395i-3(d) and 42 C.F.R. § 483.80(a)(1)-(2) because, from March 11, 2020 to May 11, 2020, it failed to maintain/implement its IPCP concerning the screening of staff for fever and symptoms of respiratory infection.  

CMS alleges that Petitioner did not comply with the following Medicare program requirement for SNFs: 

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[.] 

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42 U.S.C. § 1395i-3(d)(3)(A); 42 C.F.R. § 483.80.  As stated above, it is not enough for an SNF to establish an IPCP, the SNF must implement that IPCP.  Golden Living Ctr. – Superior, DAB No. 2768 at 7; Heritage House, DAB No. 2566 at 12. 

As demonstrated above, Petitioner failed to fully implement its IPCP concerning staff screening for fever and respiratory infection symptoms.  Although Petitioner submitted a few statements from staff who had not been properly screened stating that they never had fever or respiratory symptoms, these statements do not cover all of the lapses identified above.  Further, the employee statements were not prepared as affidavits or declarations and not subject to cross-examination. 

Rather than denying that its staff screening was imperfect, Petitioner provides other arguments in an effort to show it was not out of substantial compliance.  Chief among the arguments is that screening symptoms was not a particularly effective method to keep COVID-19 out of nursing facilities due to asymptomatic transmission of COVID-19.  P. Br. at 29-30; Tr. II at 23-24.  Because of the asymptomatic spread of the COVID-19, Petitioner argues that lapses in screening could not plausibly pose the potential for more than minimal harm.  P. Br. at 30.  Petitioner also asserts that CMS did not dispute that Petitioner’s staff was being screened or that nurses from Petitioner’s staff were following up on documentation gaps and reported symptoms on the screening forms.  P. Br. at 31-32. 

In support of these defenses, Petitioner’s witnesses testified to the ineffectiveness of screening.  Petitioner’s Medical Director testified that, by late March 2020, CDC advised health care facilities that traditional symptom-based surveillance was not effective because an individual could shed the virus for several days before exhibiting symptoms.  P. Ex. 48 at 5.  As a result, all of the residents at an SNF could be infected within days, even before becoming symptomatic.  P. Ex. 48 at 5.  The Medical Director also testified that, while some documentation for staff screening was spotty, symptom screening was not particularly effective in preventing the spread of COVID-19 and “so far as I know, nurses determined that every individual who reported symptoms of aches and pains, coughs, and the like, all provided plausible explanations other than possible COVID-19 before being allow[ed] to work.” P. Ex. 48 at 7-8.  Similarly, Petitioner’s Administrator testified that he monitored the screening of employees “and I am certain that no staff person with a fever greater than 100.4 . . . was allowed to work.” P. Ex. 47 at 6.  Petitioner’s Administrator also testified that nurses followed up on any gaps in the sign-in documentation or reports of unusual symptoms, and “nurses determined that every individual who reported symptoms of aches and pains, coughs, and the like, all provided explanations other than possible COVID-19 before being allow[ed] to work.” P. Ex. 47 at 6. 

In addition, Petitioner had two expert witnesses testify to this issue.  Dr. Katz testified that “methods to screen staff for fever and symptoms is futile, and in fact may be a

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detriment to our efforts, by giving us a false sense of security.” P. Ex. 54 at 4.  Dr. Hashisaki’s testimony agreed that controlling the asymptomatic transmission of the virus was “very difficult, if not impossible, without much stricter testing, isolation[,] and quarantine practices than the United States adopted.” P. Ex. 52 at 5.  He also opined that the most important first step is to identify everyone who is infected and to isolate them; however, this “is impossible to do without rapid testing, and without such tests there was no way for nursing facilities to identify residents and staff who were infected and contagious but had no symptoms . . . . In many cases isolation was too late, as an asymptomatic infected resident or staff member already had seeded COVID-19 in the facility.” P. Ex. 52 at 6-7.  He also stated that “screening, even if done perfectly, will miss symptomatic infected individuals who, at a nursing facility, can quickly spread the virus through the building.” P. Ex. 52 at 9-10. 

Regarding CMS’s determination that Petitioner’s deficient screening of staff entering the facility immediately jeopardized the residents, Dr. Katz asserted that “symptom screening of staff has been woefully inadequate to prevent entry of the virus in to nursing homes- the only effect on preventing entry we have seen has been regular testing of staff for COVID-19 on at a minimum a weekly basis.” P. Ex. 54 at 4.  Both Petitioner’s Administrator and Medical Director testified that rapid testing was not available until mid-May 2020.  P. Ex. 47 at 8-9; P. Ex. 48 at 5-6; see Tr. I at 187.  Dr. Hashisaki opined that “any shortcomings in the screening process or documentation seem to me to be very unlikely to have had any impact on the spread of the virus given the timing of the outbreak.” P. Ex. 52 at 10.  

While Petitioner’s argument may appear valid on the surface, it does not survive scrutiny.  As stated in the controlling statute, the IPCP is not meant to be able to ensure that no infectious diseases are transmitted in a facility.  Rather the IPCP has “to help prevent the development and transmission of disease and infection.” 42 U.S.C. § 1395i-3(d)(3)(A); 42 C.F.R. § 483.80 (emphasis added).  There is no doubt that Petitioner, CDC, and CMS all thought screening could “help.”  

In CDC’s April 13, 2020 recommendations, CDC expressly stated that there was asymptomatic and pre-symptomatic transmission of COVID-19.  P. Ex. 15 at 1.  Despite this, CDC still recommended “actively screen[ing] everyone for fever and symptoms of COVID-19 before they enter the healthcare facility.” P. Ex. 15 at 1.  Along with this, CDC also recommended that healthcare personnel “should wear a facemask at all times while they are in the healthcare facility.” P. Ex. 15 at 4.  CDC acknowledged that screening was “ineffective in identifying all infected individuals [because it] will not identify individuals who are infected but otherwise asymptomatic”; however, CDC’s answer was to recommend “aggressive source control measures,” such as “requiring [all] entering the facility to wear [at least] a cloth face covering . . . regardless [as to] symptoms.” P. Ex. 15 at 3.  Therefore, CDC endorsed the use of multiple layers of infection control practices even if such practices were each imperfect.  CDC’s April 13,

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2020 recommendations clearly show this to be CDC’s approach at that point in the pandemic.  None of Petitioner’s witnesses testified about the efficacy of screening when viewed as a single aspect of a larger effort to prevent COVID-19 spread in SNFs. 

One of Petitioner’s exhibits helps to show how a multi-layered approach can be helpful.  An occupational therapist at Petitioner’s facility signed a statement in which she stated that, on March 30, 2020, she marked on a screening sheet that she had symptoms of respiratory infection because she had a cough.  P. Ex. 38 at 10.  The occupational therapist attributed the cough to seasonal allergies.  She continued to work.  P. Ex. 38 at 10.  However, when returning home from work on March 31, 2020, she started to feel ill.  P. Ex. 38 at 10.  When she checked her temperature at home, she had a fever.  The occupational therapist then tested positive for COVID-19.  P. Ex. 38 at 10.  The occupational therapist stated that her tasks had been limited to taking food trays and water to residents while COVID-19 positive.  The therapist made it clear that: “I always wor[e] my N95 mask and PPE gear as instructed.” P. Ex. 38 at 10.  In this situation, a properly screened employee would have been sent home on March 30, 2020, reducing the chance for spreading COVID-19.  But, as implied by the therapist, wearing full PPE probably also helped avoid the spread. 

No matter the efficacy of wearing PPE, the occupational therapist ought not to have been in the facility after having symptoms of respiratory infection on March 30, 2020.  As the surveyor testified, there was no fast method of testing for COVID-19 early in the pandemic.  Therefore, “the expectation was to try to mitigate as much risk as possible by screening each employee, visitor, and/or other person that would enter the facility in order to attempt to reduce the risk of COVID-19 entering the building.” Tr. I at 35.  The surveyor said that, before rapid testing was available, “screening was a vital step to make sure the COVID-19 did not enter a building.” Tr. I at 36.  She testified that “one of the only real effective tools to prevent symptomatic infected people from entering a building was the screening requirement that CDC and CMS released.” Tr. I at 37.  The incident with the occupational therapist proves this point. 

It is impossible to take the position that Petitioner did not realize and endorse this layered approach to COVID-19.  As explained in detail above, Petitioner created the staff screening forms and implemented screening before CMS recommended it.  Ahead of CDC, Petitioner lowered the screening threshold for fever to 100.0°F.  Petitioner’s in-service training for facility staff, performed on April 7, 2020, provided: 

Every employee will be screened at the front desk at the start of shift.  Anyone showing signs and symptoms of COVID-19 will be sent home.  Employee must be symptom free for 7 days and fever free for 3 days Prior to returning to work. 

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CMS Ex. 3 at 7; P. Ex. 36 at 42.  This training is significant for showing that even as late as April 7, 2020, Petitioner was fully committed to screening as a useful tool to help reduce the transmission of COVID-19.  Even Petitioner’s Medical Director agreed that if a virus is “more dangerous and deadly, you would want to have a higher threshold for caution.” Tr. II at 31. 

Although Petitioner’s experts testified that screening was of little or no use to stopping the spread of COVID-19, they did not cite any studies to support this view.  Also, I interpret the expert testimony to mean that screening is sufficiently porous that an SNF, as a whole, cannot be protected by it because COVID-19 can enter through asymptomatic persons entering the facility and spreading it.  Essentially, this is a “big picture” approach.  However, I do not interpret the expert testimony to mean that screening would not help to identify individuals who might have COVID-19 and, if such individuals were turned away from the facility and not allowed to return for some days, might prevent COVID-19 positive individuals from entering the facility and the spread of the virus.  Essentially, the experts did not testify that turning away feverish or symptomatic employees would not help to keep COVID-19 out of the facility.  Their testimony is really one of general policy (i.e., screening alone is too porous to protect a facility) rather than saying that screening provides no help in stopping the spread of COVID-19. 

There is no doubt that Petitioner’s failure to consistently screen staff or turn symptomatic staff away placed residents at risk for more than minimum harm.  The state agency surveyor generally testified to the failure of Petitioner to completely screen staff and that there were staff who reported signs and symptoms of a respiratory illness or fever that were allowed to work (CMS Exs. 4-12).  CMS Ex. 29 ¶ 13i; Tr. I at 165.  The surveyor’s view is that “the lack of thorough screening was pervasive.  I mean, there are, as you can see, lots of, lots of holes that are present in this documentation.” Tr. I at 140. 

Further, while Petitioner appears to argue that it followed up on all discrepancies in the symptom screening forms, there is insufficient evidence to conclude this to be true.  It is generally true that the revised April 15, 2020 IPCP added a new provision that stated: “Associates with pre-existing health conditions should notify their supervisor of his/her concerns, and these will be handled on a case by case basis.” P. Ex. 28 at 4; P. Ex. 29 at 5; P. Ex. 30 at 6; P. Ex. 31 at 8; P. Ex. 32 at 9; P. Ex. 33 at 11.  However, the record in this case is devoid of facility documentation related to this provision.  Tr. I at 141 (Surveyor testifying that Petitioner did not produce documentation that there was follow-up to the incomplete screening forms.). 

As indicated in detail above, staff were allowed to work both when the screening form was incomplete and sometimes when the form showed fever and/or symptoms.  Petitioner’s failure to truly implement a proper process of staff screening violated its

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IPCP as well as CMS and CDC guidance.  Therefore, Petitioner was not in substantial compliance with 42 U.S.C. § 1395i-3(d)(3)(A) and 42 C.F.R. § 483.80.¹⁰   

Staff Use of PPE

8. IPCP provisions revised in mid-May 2020 explained that COVID-19 most commonly is transmitted through person-to-person contact in which respiratory droplets produced by an infected person while speaking, coughing or sneezing, are inhaled into the lungs by another or when droplets land on another person’s mouth, nose, or eyes.  Transmission of COVID-19 may also occur through contact with a contaminated surface followed by self-delivery to the eyes, nose, or mouth.  The IPCP stated that Standard Precautions for infection control requires strict hand hygiene and gloves; Contact Precautions require the use of PPE, such as gloves and gowns; and Droplet Precautions require at least a facemask upon entry to a resident’s room. 

As discussed earlier, Petitioner revised its IPCP many times between March and May 2020.  For purposes of the observations for the May 14-20, 2020 survey, the following IPCP revised provisions were in effect:  May 7, 2020 revised IPCP Transmission-based Precautions and Isolation Procedures; May 13, 2020 revised COVID-19 specific provisions.  CMS Ex. 2 at 1-7, 12-46. 

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Petitioner’s May 13 revised COVID-19 IPCP discussed the mode of transmission for COVID-19 as follows: 

Current data suggest person-to-person transmission most commonly happens during close exposure to a person infected with the virus that causes COVID-19, primarily via respiratory droplets produced when the infected person speaks, coughs, or sneezes.  Droplets can land in the mouths, noses, or eyes of people who are nearby or possibly be inhaled into the lungs of those within close proximity.  Transmission also might occur through contact with contaminated surfaces followed by self-delivery to the eyes, nose, or mouth.  The contribution of small respirable particles, sometimes called aerosols or droplet nuclei, to close proximity transmission is currently uncertain.  However, airborne transmission from person-to-person over long distances is unlikely.  Recent experience with outbreaks in nursing homes has reinforced that residents with COVID-19 frequently do not report typical symptoms such as fever or respiratory symptoms; some may not report any symptoms.  Unrecognized asymptomatic and pre-symptomatic infections likely contribute to transmission in these and other healthcare settings. 

CMS Ex. 2 at 12 (emphasis omitted); see also P. Ex. 15 at 2 (April 13, 2020 CDC guidelines providing similar information); Tr. I at 51 (respiratory droplet considered the primary means of transmission).  This policy said that the facility should follow CMS, CDC, and state and local health department guidance.  CMS Ex. 2 at 13. 

Regarding the modes of potential transmission for diseases, the May 7 revised IPCP on transmission-based precautions stated: 

There are three categories of Transmission-Based Precautions:  Contact Precautions, Droplet Precautions, and Airborne Precautions.  Transmission-Based Precautions are used when the route(s) of transmission is (are) not completely interrupted using Standard Precautions alone.  For some diseases that have multiple routes of transmission (e.g., SARS, COVID-19), more than one Transmission-Based Precautions category may be used.  When used either singly or in combination, they are always used in addition to Standard Precautions. 

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CMS Ex. 2 at 1 (emphasis omitted). 

“Standard Precautions” apply to all resident care and emphasizes hand hygiene as well as use of gloves, particularly when there is a potential for contact with blood or body fluid, mucous membranes, or non-intact skin.  CMS Ex. 2 at 3. 

“Contact Precautions” are to prevent the spread by direct or indirect contact with the resident or resident’s environment.  Specifically, it “require[s] the use of appropriate PPE, including a gown and gloves upon entering (i.e., before making contact with the resident or resident’s environment) the room or cubicle.  Prior to leaving the resident’s room or cubicle, the PPE is removed, and hand hygiene is performed.” CMS Ex. 2 at 4. 

“Droplet Precautions” are explained as follows: 

The use of droplet precautions applies when respiratory droplets contain viruses or bacteria particles which may be spread to another susceptible individual.  Respiratory viruses can enter the body via the nasal mucosa, conjunctivae and less frequently the mouth.  Examples of droplet-borne organisms that may cause infections include, but are not limited to Mycoplasma pneumoniae, influenza, and other respiratory viruses. 

Respiratory droplets are generated when an infected person coughs, sneezes, talks, or during procedures such as suctioning, endotracheal intubation, cough induction by chest physiotherapy, and cardiopulmonary resuscitation.  The maximum distance for droplet transmission is currently unresolved, but the area of defined risk based on epidemiological findings is approximately 3-10 feet.  In contrast to airborne pathogens, droplet-borne pathogens are generally not transmitted through the air over long distances. 

Facemasks are to be used upon entry (i.e., within six feet of a resident) into a resident’s room or cubicle with respiratory droplet precautions.  If substantial spraying of respiratory secretions is anticipated, gloves and gown as well as goggles (or face shield in place of goggles) should be worn.  The preference for a resident on droplet precautions would be to place the resident in a private room. 

CMS Ex. 2 at 4. 

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“Airborne Precautions” are explained as follows: 

Airborne transmission occurs when pathogens are so small that they can be easily dispersed in the air, and because of this, there is a risk of transmitting the disease through inhalation.  These small particles containing infectious agents may be dispersed over long distances by air currents and may be inhaled by individuals who have not had face-to-face contact with (or been in the same room with) the infectious individual. 

Associate to don N95 or higher respirator prior to room entry of a resident[.] 

Residents with infections requiring airborne precautions must be transported to an acute care setting unless the facility can place the resident in a private airborne infection isolation room (AIIR) with the door closed. 

CMS Ex. 2 at 4-5. 

9. IPCP provisions revised in mid-May 2020 required staff to wear a facemask at all times in the facility and full PPE (including a respirator mask) when caring for residents with known or suspected COVID-19. 

Petitioner’s IPCP provisions revised in mid-May 2020 provide requirements for staff use of PPE. 

Petitioner’s May 7 revised Transmission-based Precautions and Isolation Procedures indicates that when a resident is either known to have or is suspected of having COVID-19, “[a]ssociates should wear gloves, isolation gown, eye protection and an N95 or higher-level respirator if available.  A facemask is an acceptable alternative if a respirator is not available.” CMS Ex. 2 at 6.  These same PPE precautions are also required when providing care of all residents on the COVID-19 unit or facility-wide based on the location of affected residents.  CMS Ex. 2 at 6. 

The IPCP explained the difference in facemasks and face coverings.  A “respirator” is PPE that covers at least the nose and mouth and is used to reduce the wearer’s risk of inhaling hazardous airborne particles.  CMS Ex. 2 at 30; see also P. Ex. 15 at 3.  A “facemask” is PPE (often referred to as a surgical mask) that is designed to protect against splashes and sprays as well as “source control.” CMS Ex. 2 at 30, 31; see also P. Ex. 15 at 3.  A cloth face covering is “not PPE” and is only intended to stop the wearer from spreading respiratory secretions when talking, sneezing, or coughing; however, it is

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not certain that cloth face coverings will protect the wearer.  CMS Ex. 2 at 30; see also P. Ex. 15 at 3. 

Residents who are not under isolation generally only wear cloth face coverings when leaving the resident’s room or when others enter the resident’s room.  Residents who are isolated are to wear facemasks when they leave their room.  CMS Ex. 2 at 31. 

The IPCP further explains that health care personnel “should wear a facemask at all times while they are in the healthcare facility.” CMS Ex. 2 at 31; CMS Ex. 2 at 21 (“Per CMS directive issued 4/2/2020, all facility associates should wear a facemask while they are in the facility for the duration of the state of emergency in their state.”); see also P. Ex. 15 at 4.  Further, it warns that cloth face coverings should not be worn instead of a respirator or facemask if more than source control is required.  CMS Ex. 2 at 31.  The IPCP also notes that some associates at the facility, such as business office personnel, maintenance, and housekeepers, “might wear their cloth face covering for part of the day when not engaged in direct resident care activities, only switching to a respirator or facemask when PPE is required.” CMS Ex. 2 at 32. 

The IPCP also provides “additional” infection control recommendations for suspected and/or active COVID-19 cases in the facility.  These include the following:  implementing universal source control (facemask or face coverings) while in the facility; wearing full PPE per CDC guidelines for the care of any resident with known or suspected COVID-19; and wearing all recommended COVID-19 PPE for the care of residents on an affected unit (or facility-wide if cases are widespread), including both symptomatic and asymptomatic residents.  CMS Ex. 2 at 37. 

The CDC is explicit that health care personnel who enter the room of a resident with known or suspected COVID-19 should use a respirator and, only if there is no respirator available, should use a facemask.  Further, health care personnel should wear gowns, gloves, and eye protection.  P. Ex. 15 at 5-6. 

In addition to the formal IPCP documents described above, Petitioner trained its staff on IPCP procedures.  In an in-service training performed on April 7, 2020, Petitioner trained its staff on the following: 

Infection control practice.  All staff working on the 3rd and 4th floor will don PPE upon arrival to unit.  All staff will keep PPE on the entire time on the unit.  PPE will be removed prior to leaving the unit.  Staff working the above mentioned units will not be allowed on any other unit. 

P. Ex. 36 at 44; CMS Ex. 3 at 6.  The surveyor testified that this training meant that Petitioner’s infection control practice was for all staff to keep PPE on the entire time

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while they were on the unit (i.e., the third or fourth floors of the facility) and the PPE would only be removed prior to leaving the unit.  Tr. I at 152-153. 

10. From the beginning of the pandemic through the May 14-18, 2020 survey, Petitioner’s facility never ran out of PPE for its staff.  During that time, Petitioner limited N95 respirator use for patient care. 

In its guidance updated on April 13, 2020, the CDC discussed shortages in PPE, including N95 respirator masks.  P. Ex. 15 at 2.  Petitioner’s Administrator testified that at the beginning of the pandemic, facility staff would use N95 respirator masks, surgical masks, or cloth masks because Petitioner only had a limited number of N95 respirator masks available.  He further testified that Petitioner attempted to get additional supplies and “consolidate the usage, reduce the burn rate as much as possible, and use the supplies we could to effectively mediate the pandemic that we were going through.” Tr. I at 191-92, 199. 

The Administrator testified that “as time would go on, we would change our policy to reflect what we had on hand and then also, guidance that we were getting as well.” Tr. I at 192.  The Administrator stated that the facility “never completely ran out of any PPE, but we did run short of some supplies, and so followed CDC guidance to conserve and reuse some gowns, which the CDC permitted at the time . . . .” P. Ex. 47 at 7; see P. Ex. 50 at 4.  The Administrator testified that it was not until April 13, 2020 that CDC recommended for the first time “source control for everyone entering a healthcare facility regardless of symptoms.” P. Ex. 47 at 9.  CDC also recommended full PPE – N95 mask, gown, facial protection – for anyone entering “the room of a patient with known or suspected COVID-19.” The Administrator indicated that “[w]e actually already were going further than this guidance, and requiring full PPE for all direct resident care.” P. Ex. 47 at 10.  He also stated that CDC recommended universal masking but indicated N95 respirator masks were reserved for direct caregivers, and that other staff could wear cloth or surgical masks when not engaged in direct care. “As noted, we already provided for all staff to wear surgical or cloth masks when in the building, and N95 masks when providing direct resident care.” P. Ex. 47 at 10.  Further, “we required staff to wear gowns only when providing direct resident care, or other activities that could expose them to the virus.” P. Ex. 47 at 10. 

The Administrator testified that during the CMS survey “we were doing fairly well on the surgical masks and we could reduce down to those”; however “we were still, what do they call it, extended use, and really utilizing that tremendously so that we wouldn’t run out of supplies.” Tr. I at 193.  The Administrator described the use of different masks at the time of the survey: “Typically, with resident care, we’d have N95, and then up on the floor, you’d see the surgical masks.  Typically, down on the 1st floor, if they weren’t around residents or anything, that might be where somebody would have a cloth, but would switch over to another one on a different floor.” Tr. I at 193. 

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The surveyor testified that “[w]hile PPE shortages can affect what PPE gear should be worn and when, the [Central Supply] supervisor said the facility had not experienced a shortage of PPE, and at the time of the survey, the facility had PPE for five to six days.” CMS Ex. 29 ¶ 13h; see Tr. I at 108. 

11. Following an outbreak of COVID-19 among residents and staff at Petitioner’s facility in late March 2020, the facility engaged in cohorting of residents and staff.  The fourth floor of the facility was dedicated to residents who were COVID-19 positive.  The third floor was dedicated to residents whose COVID-19 status was under investigation.  The second floor was dedicated to residents who were COVID-19 negative.  By the time that the May 14-18, 2020 survey took place, all residents were only on the second and third floors. 

By mid-March 2020, Petitioner had instated a policy concerning the use of cohorting residents based on their infection status.  See P. Ex. 47 at 13.  According to testimony from Petitioner’s witnesses, Petitioner implemented cohorting of residents and staff three weeks before the CDC suggested it.  This occurred after Petitioner’s staff learned of the first COVID-19 positive test results for three residents who had been sent to a hospital.  The fourth floor of the facility was designated as the infected floor (Red), the third floor as the “under investigation” floor (quarantine and awaiting test results) (Yellow), and the second floor as the “clean” floor” (Green) for persons who tested negative and did not exhibit symptoms for COVID-19.  P. Ex. 47 at 9-11; P. Ex. 48 at 9; P. Ex. 50 at 3.  Staff were also cohorted, so that staff could not move from one floor to another.  P. Ex. 47 at 11; P. Ex. 48 at 9; P. Ex. 50 at 3.  At the time of the survey, there were residents on the second and third floors but not the fourth floor because there were no known COVID-19 infections among the residents.  Tr. I at 174. 

Petitioner’s general cohorting measures comported with its IPCP.  Petitioner’s IPCP’s provision on Transmission-based Precautions and Isolation Procedures, revised as of May 7, 2020, provided that: “If possible, the facility may consider closing units where symptomatic and asymptomatic residents reside and cohorting staff on either affected or non-affected units to prevent transmission between units.” CMS Ex. 2 at 6.  Petitioner’s IPCP provision on COVID-19, revised May 13, 2020, stated that the facility should place residents in dedicated areas of the facility based on COVID-19 status, with confirmed COVID-19 positive cases placed on transmission-based precautions (droplet and contact) and cohorted together.  CMS Ex. 2 at 18. 

As stated above, at the time of the May 14-18, 2020 survey, none of the residents were COVID-19 positive.  The May 13, 2020 revised COVID-19 IPCP provision also stated that residents with unknown COVID-19 status (e.g., residents awaiting test results or ones who have been admitted or readmitted to the facility where they were likely exposed to COVID-19) should also be grouped together and that group warrants transmission- based precautions “(droplet plus contact with eye protection.).” CMS Ex. 2 at 19. 

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Specifically, the IPCP stated that “[a]ll recommended COVID-19 PPE should be worn during the care of residents under observation, which includes use of an N95 or higher-level respirator (or facemask if a respirator is not available), eye protection (i.e., goggles or a disposable face shield that covers the front and sides of the face), gloves, and gown.” CMS Ex. 2 at 19-20 (emphasis omitted).  The final grouping of residents was for COVID-19 negative residents (i.e., asymptomatic residents who are not suspected of having COVID-19, asymptomatic residents who tested negative for COVID-19, or residents who recovered from COVID-19).  Droplet precautions were required for all staff providing direct care due to ongoing community transmission of COVID-19.  CMS Ex. 2 at 20. 

12. On May 10, 2020, and May 15, 2020, staff members at Petitioner’s facility tested positive for COVID-19.  Therefore, while the facility did not have any COVID-19 positive residents at the time of the May 14-18, 2020 survey and May 21, 2020 re-visit survey, residents had been recently exposed to COVID-19 and were still in the 14-day period where it was unknown if any would become COVID-19 positive. 

Petitioner’s Medical Director testified that the COVID-19 outbreak that commenced late in March 2020 “ran its course within about six weeks.”  P. Ex. 48 at 9.  However, shortly after that approximate six-week period, in the week before the May 14-18, 2020 survey, a facility staff member tested positive for COVID-19 and the area surrounding the facility was experiencing COVID-19 transmission.  CMS Ex. 29 ¶ 10.  The Medical Director’s testimony did not account for the COVID-19 positive employee. 

A facility employee, designated as PTA1, was tested May 8, 2020 and received a positive COVID-19 result on May 10, 2020.  In a May 15, 2020 email to the Administrator, a patient list with dates back to April 28, 2020 were listed for the patients seen by this physical therapy staff member.  The list indicates ten residents who were exposed to PTA1, nine of which were seen by PTA1 between five and eight times from April 28, 2020 to May 8, 2020.  Tr. I at 174-75; CMS Ex. 3 at 3. 

A facility employee, designated as Employee 1, was tested for COVID-19 on May 13, 2020, and a COVID-19 positive result was received on May 15, 2020.  In a May 15, 2020 email to the Administrator, a patient list with dates back to May 1, 2020 were listed for the patients that presumably interacted with this Employee 1.  The list indicates 21 residents who were exposed to Employee 1 from May 1 to May 12, 2020, five of which were exposed numerous times.  Tr. I at 175; CMS Ex. 3 at 3. 

The surveyor testified that during the events observed during both the May 14-18, 2020 survey and the May 21, 2020 re-visit survey, the facility staff should have been wearing full PPE in the facility because 14 days since the facility staff who tested positive had not yet run.  Tr. I at 175, 177; see also CMS Ex. 2 at 19 (IPCP provides that residents for

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which it is unknown if they have COVID-19 but have not been tested, the standard is that they are no longer suspected of having COVID-19 if they go 14 days afebrile and without respiratory infection symptoms.); Tr. I at 42. 

Q. Okay.  Okay.  Let’s see, I think -- and so based on two staff members testing positive within that 14-day window, should the facility, especially on that yellow floor, been wearing the full -- staff who worked on that floor be wearing the full PPE? 

A. Yes, because COVID-19 had been identified in the facility, it would have been expected, especially since these staff had access to all residents on both floors, that full PPE would have been worn for the care of all residents in the facility. 

Tr. I at 177. 

13. Based on the survey conducted from May 14-18, 2020, the SOD details several instances where Petitioner’s staff allegedly failed to comply with provisions of Petitioner’s IPCP concerning the use of PPE.  As specified below, some of the allegations show violations of the IPCP and some allegations do not show a violation of the IPCP.  The violations of the IPCP showed a potential for more than minimal harm to residents. 

Below I discuss each of the incidents alleged in the SOD concerning staff failures to follow Petitioner’s IPCP.¹¹ 

1. On May 14, 2020, Licensed Practice Nurse (LPN1) pulled down her N95 respirator mask when speaking with a surveyor.  An hour later on

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the same date, LPN1 was working on a computer at the nurse’s station with her mask lowered beneath her nose and mouth.  These actions violated Petitioner’s IPCP and presented a situation that posed the potential for causing more than minimal harm.  LPN1’s refusal to wear a mask on the third floor of the facility at all times constituted a significant threat to the residents. 

The SOD alleged the following incidents occurred: 

On 5/14/2020 at 8:40am, Licensed Practical Nurse (LPN1), who stood at the medication cart on the second floor, pulled her N95 respirator mask down, exposing her mouth and nose . . . . LPN1 indicated that she knew pulling her facemask down to expose her mouth and nose was not proper mask usage, and could expose herself and/or other residents to possible contagions. 

* * * * *

On 5/14/2020 at 9:40am, LPN1 sat at the computer at the nursing station.  LPN1 wore a facemask, however, the mask was pulled beneath her chin, leaving her mouth and nose exposed. 

CMS Ex. 1 at 5, 7.  The surveyor clarified in testimony that LPN1 lowered the mask to speak with the surveyor.  CMS Ex. 29 ¶ 13a.  The surveyor also testified that LPN1 was wearing her facemask below her chin while working at a computer at the nurse’s station.  CMS Ex. 29 ¶ 13a.  Petitioner did not submit written testimony from LPN1 to dispute that these incidents occurred. 

Petitioner argues that LPN1 was not providing direct resident care at the time she lowered her mask and was not within six feet of any resident.  Furthermore, Petitioner believes transmission of COVID-19 in both circumstances when LPN1 removed her mask would be remote.  P. Br. at 33, 37.  CMS argues that Petitioner’s IPCP requires staff to wear facemasks at all times while in the facility and LPN1 violated this portion of the IPCP.  CMS Br. at 17, 19. 

CMS is correct.  As explained in greater detail above, the IPCP states that “all facility associates should wear a facemask/face covering while they are in the facility for the duration of the state of emergency in their state.” CMS Ex. 2 at 21; see also P. Ex. 35 at 10 (Petitioner posted posters in the facility reminding staff to “[w]ear facemask at all times.”).  There is no doubt that there was a state of emergency in Missouri on May 14, 2020 concerning COVID-19.  CMS Ex. 26 at 1-2.  Further, another portion of the IPCP

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instructs that staff will remove their personal facemasks or coverings when entering the facility and put on facemasks or coverings provided by the facility.  It also states: “[Healthcare personnel] should wear a facemask at all times while they are in the healthcare facility. . . .” CMS Ex. 2 at 31.  Therefore, LPN1’s lowering of her N95 and exposing her mouth and nose when speaking with the surveyor violated the IPCP.  Sitting and working on a computer on the third floor of the facility without a mask on also clearly violates Petitioner’s IPCP. 

Various witnesses testified about this matter.  Petitioner’s Medical Director testified that the first time LPN1 lowered her mask, LPN1 was presumably in the hallway and that, while staff should be masked at all times, working at a medication cart is not direct resident care and does not require full PPE and N95 mask.  The Medical Director opined that transmission by the nurse was remote.  P. Ex. 48 at 11.  The Medical Director testified that when LPN1 was working at a computer terminal at the nursing station with her mask pulled down there was “no plausible risk of transmitting the virus to or from a resident, since it is unlikely that any resident came within six feet of the nurse, and at any event, at the time any resident who had to use the hallway for transit would have been wearing a mask.” P. Ex. 48 at 12. 

I cannot credit the Medical Director’s testimony as to the potential risk of harm.  The Medical Director’s testimony admitted that LPN1 should have been masked at all times.  Further, the Medical Director did not discuss LPN1’s risk of being exposed while conversing with a surveyor.  The surveyor moved between facilities to conduct surveys and was unknown to LPN1.  If LPN1 became exposed to COVID-19, then residents on the second floor could be at significant risk of being infected.  This is because the second floor had residents who were neither COVID-19 positive nor suspected, which meant that they generally did not wear a facemask or covering and only wore a cloth covering when a health care provider, like LPN1 was with the resident.  CMS Ex. 2 at 31.  The IPCP warns that there is uncertainty whether a cloth covering protects the wearer because it is primarily intended to stop the spread of respiratory excretions from the wearer.  CMS Ex. 2 at 30.  Given the highly contagious nature of COVID-19, LPN1 was obligated not to lower her mask to talk with the surveyor.  Further, LPN1 was working at the nurse’s station with her mask lowered, which was the second time she lowered the mask within an hour.  The Medical Director’s testimony did not discuss the potential from harm by an employee who refused to follow the strict masking rule in the IPCP. 

Dr. Katz also testified that she did not believe LPN1’s actions were problematic.  She testified that “[w]ithout being within 6 feet of another individual and lowering the mask for a brief moment, the risk of transmission for this act is negligible.” P. Ex. 54 at 5.  Dr. Katz’s opinion is based on factual assumptions not shown in the record.  One assumption is that LPN1 only lowered her mask “for a brief moment,” and another is that she was not within six feet of another individual.  P. Ex. 54 at 5.  Dr. Katz did not account for the surveyor’s written testimony that LPN1 pulled the mask down to speak to the surveyors. 

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CMS Ex. 29 ¶ 13a.  This not only shows that her mask was down for more than a brief moment but that LPN1 breached a fundamental requirement to keep her mask on since speaking to others without a mask would necessarily include the potential for transmitting the virus into the air or breathing in any virus that may be transmitted into the air by the surveyor.  Further, given the unlikely situation that LPN1 shouted across the hall to speak to the surveyor, LPN1 and the surveyor were within a reasonable distance to each other.  As stated above, LPN1 lowered her mask to speak to a surveyor who was from outside the facility and who could have been an asymptomatic spreader of the virus. 

I consider Dr. Katz’s testimony to be potentially flawed based on her factual assumptions.  I also think that it contradicts her testimony about the very real threat of the spread of COVID-19 through asymptomatic persons.  Dr. Katz testified: “What we did not know, is that approximately 40%! of individuals may carry [COVID-19] and the ability to transmit the virus while being completely asymptomatic.  This asymptomatic and presymptomatic spread is a significant driving factor for the large outbreaks we have seen time and time again in long-term care facilities.” P. Ex. 54 at 3. 

LPN1 was a significant threat to residents.  LPN1 demonstrated that Petitioner’s IPCP was not being implemented.  LPN1 lowered her mask to speak with people, which is exactly the time when the mask is most necessary (along with coughing or sneezing).  LPN1 also worked at the nurse’s station without wearing a mask.  She did these acts an hour apart, evidencing a likely practice of removing her mask.  She also did this while surveyors were observing her.  The risk of more than minimal harm is shown through an employee failing to conform to the most basic method of helping to ensure that COVID-19 does not spread.  Given the significant threat of any transmission of the virus in the SNF setting, LPN1’s failure to keep her N95 mask raised on her face constituted a risk for more than minimal harm to residents. 

2. On May 14, 2020, Maintenance Staff (M1) failed to change her gloves and engage in hand hygiene after cleaning a resident’s room and before entering the next resident’s room.  Because M1’s normal duties included cleaning each resident’s bathroom toilet and cleaning items within reach of residents (e.g., bed stands, bed rails, call buttons), M1’s failure to follow hand hygiene rules after touching potentially infectious materials violated Petitioner’s IPCP and presented a situation that posed the potential for causing more than minimal harm.  M1’s decision to wear a facemask instead of a respirator mask, while contrary to facility instructions, did not violate the IPCP because M1 did not engage in care of the residents. 

The SOD alleged the following incident occurred: 

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On 5/14/2020 at 9:00am, Maintenance staff (M1) left resident room 234 after cleaning the room.  M1 wore a disposable gown, gloves, and a disposable surgical mask.  M1 failed to change her gloves and sanitize her hands after leaving the room.  M1 then entered resident room 235 and began cleaning, continuing to wear the same gloves.  M1 cleaned the bathroom of room 235.  M1 indicated that she failed to change her gloves and sanitize her hands after cleaning room 234, indicating that normally, she only would change her gloves.  M1 also indicated that the facility provided her with an N95 respirator, but that she chose to wear disposable surgical masks, because the N95 was uncomfortable, and that she “had hot flashes and couldn't wear them.”

CMS Ex. 1 at 5-6; CMS Ex. 29 ¶ 13b. 

CMS argues that M1 failed to exercise proper hand hygiene because M1 neither changed her gloves nor washed her hands after cleaning one resident’s room and commencing to clean another.  CMS Br. at 8, 18.  CMS also argues that due to recent COVID-19 positive test results for two staff members at Petitioner’s facility, M1 should have been wearing an N95 in a resident’s environment.  CMS Br. at 8 n.5. 

Petitioner argues that M1 was not engaged in “direct resident care” and that it was not necessary for a housekeeper to change PPE unless it was visibly soiled.  P. Br. at 33. 

Petitioner did not provide testimony from M1.  Therefore, the facts as alleged are not disputed. 

Petitioner’s IPCP indicates that housekeeping staff are at a medium risk of exposure to COVID-19, noting that they have jobs “that require frequent and/or close contact with (i.e., within 6 feet of) people who may be infected with COVID-19, but who are not known or suspected COVID-19 residents.” CMS Ex. 2 at 23.  Given that housekeepers are to clean “high-touch surfaces at least once daily,” such as “bedrails, IV poles, . . . bedside tables, . . . [and] call bells,” it is clear that housekeepers work in close proximity to residents.  P. Ex. 18 at 45.  Therefore, while it is not clear from the IPCP that housekeepers technically provide direct resident care, their duties frequently bring them within six feet of residents. 

Further, it is also important to note that Petitioner’s IPCP concerning Hand Hygiene applies to associates at the facility (i.e., not limited to health care providers).  That policy indicates that the purpose of hand hygiene is to decrease the risk of transmission of infection. “Handwashing/hand hygiene is generally considered the most important single procedure for preventing nosocomial [facility acquired] infections.” CMS Ex. 2 at 47. 

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The IPCP indicates facility associates need to be trained on performing hand hygiene with a disinfectant or soap and water “[a]fter contact with potentially infectious materials.” CMS Ex. 2 at 47.  Among a long list of items to clean in each resident room, the housekeeper is to clean the toilet bowl and seat.  P. Ex. 18 at 19-20. 

The IPCP also has provisions specifically dealing with housekeeping services.  The purpose of housekeeping services is to promote a sanitary environment.  P. Ex. 18 at 44.  It provides basic cleaning procedures, but they do not specify PPE usage.  P. Ex. 18 at 44-47.  However, Petitioner’s Administrative Policies and Procedures Manual policy for Daily Room Cleaning (Revised April 7, 2020) states that “each resident’s room is maintained on a daily basis by housekeeping staff to provide a fresh, clean, and sanitary environment and reduce the potential for nosocomial infections.  All housekeeping personnel must adhere to infection prevention and control guidelines.  Please reference the Standard Precautions policy, the Transmission-Based Precautions and Isolation Procedures policy and the Personal Protective Equipment (PPE) policy.” P. Ex. 18 at 18.  This is consistent with another IPCP provision that notes that some associates at the facility, such as business office personnel, maintenance, and housekeepers, “might wear their cloth face covering for part of the day when not engaged in direct resident care activities, only switching to a respirator or facemask when PPE is required.” CMS Ex. 2 at 32. 

The Medical Director testified that the housekeeper’s function did not involve patient care so full PPE was not necessary.  Further, she testified that CDC was recommending reuse of PPE when not absolutely necessary for patient care; therefore, the situation with M1 does not describe a poor practice.  P. Ex. 48 at 11. 

Dr. Katz disagrees that the housekeeping staff member needed to wear an N95 mask while cleaning a resident’s room.  She stated that “there was no active COVID transmission in the facility” and such use would be inconsistent with CDC recommendations and contrary to efforts to preserve PPE.  P. Ex. 54 at 5.  I give Dr. Katz’s opinion limited weight because Dr. Katz did not identify which CDC recommendations she was referring to and failed to account for the fact that a facility staff member had tested positive just a few days before the housekeeper was observed.  Further, Dr. Katz did not opine as to whether the housekeeper’s use of the same gloves to clean the rooms of two residents was appropriate. 

The surveyor testified that the housekeeper was not providing direct resident care but explained that the housekeeper needed to engage in hand hygiene after cleaning the bathroom where there had been fecal matter.  Tr. I at 102.  Although the surveyor discussed how cleaning toilets could cause the transmission of COVID-19 if there was a failure to change gloves and clean hands, the surveyor’s point is clear that cleaning an area that involves fecal matter means that your gloves are contaminated with potentially disease-causing matter.  Tr. I at 102-04.

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There can be no doubt that cleaning a toilet will expose one’s hands to “infectious materials,” whether or not that is COVID-19.  As indicated above, the housekeeper was also to clean bed rails, bed tables, and call buttons, which are all in direct contact with the resident.  M1’s failure to change her gloves and clean her hands between rooms violated the IPCP for hand hygiene.  I also find that this posed the potential for more than minimal harm.  By moving from room to room without engaging in proper hand hygiene after cleaning bathrooms, M1 potentially could have spread fecal matter to surfaces that other residents would normally touch. 

Although Petitioner’s IPCP lacks clarity, I cannot conclude that it required M1 to wear a respirator, as opposed to a facemask.  There is no doubt that the facility told M1 to wear a respirator and issued one to M1, and M1 disobeyed the facility.  However, M1 was on the second floor of the facility where the residents were COVID-19 negative.  Although COVID-19 had been in the facility through infected employees, the IPCP primarily only requires respirator masks for patient care.  Given the early stage of COVID-19, CDC guidance and, as a result, the IPCP, appear to be more lenient concerning the use of facemasks in recognition of potential supply issues.  As a result, the IPCP simply is not stringent enough to encompass M1’s actions concerning the use of a facemask instead of a respirator. 

3. On May 14, 2020, Petitioner’s Central Supply (CS) supervisor was seen on the second floor of the facility with only a facemask as PPE.  Shortly after that, the CS supervisor and the Administrator were seen leaving the elevator together on the third floor of the facility, both with only facemasks as PPE.  According to Petitioner’s IPCP, full PPE with respirators was only required for staff providing care to residents.  Further, according to the IPCP, only staff providing care to residents were subject to cohorting; therefore, administrative staff could move between floors at the facility.  Therefore, I do not find that these observations from the surveyor support the deficiency in this case. 

The SOD alleged the following incidents occurred: 

On 5/14/2020 at 9:10am, the Central Supply (CS) supervisor stepped out of the elevator onto the 2nd floor.  The CS supervisor wore only a disposable surgical mask, and failed to wear any other PPE.  The CS supervisor indicated that the expectation of facility staff was that all staff were to wear gowns and facemasks while on the 2nd and 3rd floors, because of the COVID-19 outbreak. 

* * * * *

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On 5/14/2020 at 9:25am, the Administrator and the CS supervisor exited the elevator onto the 3rd floor.  Both wore disposable surgical masks, and failed to wear any other PPE. 

CMS Ex. 1 at 6-7.  The surveyor’s testimony clarified that the CS supervisor’s appearance on both the second and third floors of the facility violated the facility’s policy to cohort staff on different floors of the facility based on COVID-19 status of the residents.  CMS Ex. 29 ¶ 13c.  The surveyor also testified that the Administrator and CS supervisor violated Petitioner’s policy that staff wear full PPE while on the third floor of the facility (i.e., the yellow floor for suspected cases of COVID-19).  CMS Ex. 29 ¶ 13e. 

CMS argues that the CS supervisor was seen on the second floor of the facility and then on the third floor.  CMS asserts that Petitioner was engaging in resident and staff cohorting and had determined that staff were not permitted to move between the floors.  CMS Br. at 18.  Further, CMS argues that the Administrator and the CS supervisor were required to wear full PPE, including an N95 respirator when on the third floor.  CMS Br. at 19. 

Petitioner argues that neither the Administrator nor the CS supplier were engaged in direct patient care, so there was nothing wrong with only wearing a surgical mask.  Petitioner also asserts that there is nothing in the IPCP that Petitioner intended to cohort administrative staff.  Petitioner states that cohorting of staff means staff who provide care to residents.  Petitioner also broadly attacks cohorting as useless by the time of the survey because there were no COVID-19 positive residents in the facility at that time and that there was no chance of harm through the actions of the Administrator and CS supplier.  P. Br. at 20, 34-35. 

In support of Petitioner’s position, the Medical Director testified that there was nothing wrong with the CS supervisor’s use of the surgical mask because no patient care was involved.  P. Ex. 48 at 11.  The Medical Director testified that the CS supervisor and Administrator’s lack of PPE and wearing surgical masks was not a violation of CDC guidelines.  P. Ex. 48 at 12. 

Neither CMS in briefing nor the surveyor in her testimony assert that the CS supervisor’s presence on the second floor with a facemask was a violation of the IPCP.  Because the second floor was a COVID-19 negative floor and the CS supervisor was not engaging in resident care, the observation of the CS supervisor on the second floor, taken alone, is not a violation of the IPCP. 

I also do not find that Petitioner’s cohorting was intended to restrict movement of administrative personnel between floors in the facility.  While the IPCP does not provide sufficient detail to answer this question, the April 13, 2020 revised CDC guidelines indicates that staff cohorting is for “dedicated [health care personnel], to care for patients

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with known or suspected COVID-19.  Dedicated means that [health care personnel] are assigned to care only for these patients during their shift.” P. Ex. 15 at 7.  It is not reasonable that the Administrator of a facility would not be permitted to move about the facility to ensure that all is as it should be in the facility.  The supply manager would also need to move through the facility to ensure that health care personnel have necessary supplies. 

Finally, I do not find that the Administrator and CS supervisor violated Petitioner’s IPCP when they entered on the third floor without full PPE.  The IPCP only requires full PPE for individuals engaging in resident care.  CMS does not rely on the IPCP to show that the Administrator and CS supervisor needed to wear full PPE.  Rather, CMS points to in-service training performed on April 7, 2020, which stated the following: 

Infection control practice.  All staff working on the 3rd and 4th floor will don PPE upon arrival to unit.  All staff will keep PPE on the entire time on the unit.  PPE will be removed prior to leaving the unit.  Staff working the above-mentioned units will not be allowed on any other unit. 

P. Ex. 36 at 44; CMS Ex. 3 at 6.  However, this training statement only applies to staff working on the third and fourth floors of the facility.  The Administrator and CS supervisor were not working on those floors.  While this may seem like a fine distinction, taken with CDC’s cohorting rule, it seems clear that the Administrator and CS supervisor were not required to wear full PPE so long as they did not enter resident rooms or perform resident care. 

It bears mentioning that Petitioner’s argument that it no longer needed to cohort by the time of the survey because there were no active COVID-19 cases is incorrect.  At the hearing, the surveyor was asked whether staff cohorting was necessary when none of the residents were COVID-19 positive in the facility.  The surveyor responded that shortly before the survey, a facility staff member had tested positive.  Further, the facility needed to follow its policy until it changed the policy.  Tr. I at 109-111. 

A. I believe they had tested positive on May the 8th, and that was within the 14-day window for incubation, so because they had had COVID-19 in the facility, they couldn’t guarantee that there weren’t -- that it wasn’t incubating in residents, that it wasn't spreading throughout the facility, and so it would be expected that they would try to keep staff in the same area as much as possible to try to prevent the spread of COVID-19 throughout the building. 

* * * * *

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Q. I mean, if this staff person had worked with residents, we don’t know who she exposed, so what difference does it make if somebody else goes from unit to unit? 

A. Because at the time, you wouldn’t know who had contracted it and who didn’t, so by keeping everybody in one location as much as possible, you would contain the -- you could attempt to contain the spread of the virus.  

Q. Well, again, I don’t mean to be argumentative, but if the physical therapist had worked with somebody on the 2nd floor, somebody on the 3rd floor, and somebody on the 4th floor, right, and none of them had tested positive and none of them had exhibited symptoms yet, any of those people could be spreading COVID asymptomatically on any of the three floors, so what difference does it make if somebody else is going from floor to floor if everybody is already been exposed?  

A. Because by -- once again, by trying to limit access to different areas of the building when you have identified COVID-19, especially when you’re within that 14-day window for incubation and things like that, it would be, it would be beneficial to try to prevent the spread throughout the rest of the facility as much as possible. 

Tr. I at 112-114.  Therefore, while I find that Petitioner’s IPCP did not technically preclude the Administrator and CS supervisor from entering the third floor with less than full PPE, Petitioner’s facility was appropriately continuing to cohort residents based on COVID-19 positive staff that had recently been in the facility. 

4. On May 14, 2020, LPN2 was on the third floor of the facility where COVID-19 suspected residents were living and was observed to wear a facemask instead of a respirator in violation of Petitioner’s IPCP.  LPN2 stated that she did this because she found the respirator mask uncomfortable.  Shortly after that, LPN2 was observed to take medication to a resident without wearing gloves.  Wearing gloves was required by the IPCP.  Therefore, LPN2’s actions violated the IPCP and posed the risk of causing more than minimal harm to residents. 

The SOD alleged the following incidents occurred: 

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On 5/14/2020 at 9:27am, LPN2 wore a disposable surgical facemask.  LPN2 indicated that the facility provided her with an N95 respirator, but chose not to wear it because it was uncomfortable.  Two boxes of N95 respirators sat on the counter of the nursing station. 

On 5/14/2020 at 9:35am, LPN2 stood at the medication cart and finished preparing medications for a resident.  LPN2 then took the prepared medications and entered resident room 330, wearing eye protection, a gown, an N95 respirator, and disposable shoe covers.  LPN2 failed to wear gloves while giving the resident their medications. 

CMS Ex. 1 at 7. 

The surveyor testified that she observed LPN2 on the third floor of the facility.  The surveyor first observed LPN2 to be wearing a surgical mask instead of an N95 respirator mask.  CMS Ex. 29 ¶ 13f.  Shortly after that, the surveyor testified that LPN2 took medications to a resident without wearing gloves (although by this time LPN2 had donned an N95 respirator mask).  CMS Ex. 29 ¶ 13g. 

Regarding LPN2’s failure to wear gloves when providing medications to a resident, Petitioner argues that the issue is whether LPN2 washed her hands before taking the medication to the resident.  P. Br. at 37. 

The Medical Director did not testify about LPN2’s use of a facemask instead of a respirator but did testify that LPN2 did not need to use gloves to administer medications to a resident so long as LPN2 washed her hands before and after the resident encounter.  P. Ex. 48 at 12.  One of Petitioner’s nurses also testified about the administration of medication.  The nurse did not approve of a nurse administering medication to a resident while not wearing gloves but stated that an ungloved hand is no more likely to spread COVID-19 than a gloved hand.  P. Ex. 50 at 5.  However, the nurse admitted that a requirement to wear full PPE meant that gloves must be worn when providing direct care for a resident.  Tr. II at 43. 

The surveyor testified that LPN2 had failed to have full PPE (i.e., the respirator) despite being on the third floor of the facility where residents of unknown COVID-19 status were living.  Tr. I at 122.  The surveyor thought that there was a risk to LPN2’s actions because it had only been a few days earlier that a facility employee had tested positive for COVID-19, making it quite possible that others at the facility had been infected.  Tr. I at 123. 

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Regarding LPN2’s failure to don gloves before taking medication to a resident, the surveyor testified that gloves are considered part of PPE.  Tr. I at 157.  She noted that LPN2 was working on the third floor where COVID-19 suspected residents were located.  Tr. I at 157.  The surveyor testified that it is possible for an individual to come into contact with saliva and mucous membranes when administering medications orally.  Tr. I at 157.  Because of this, the IPCP (CMS Ex. 2 at 3) supported use of gloves.  Tr. I at 157-158.  The surveyor also testified as follows: 

Q. Is it typical for nurses to administer medications while wearing gloves? 

A. If the resident is on precautions, then yes, it is. 

Q. What sort of precautions? 

A. Droplet precautions. 

Q. So in your experience as a nurse, it’s typical for nurses to administer medications while wearing gloves to any resident on droplet precautions. 

A. Yes, because gloves are required whenever you’re -- when you would be entering the resident room if they were on droplet precautions. 

Q. All right. Did you ask any physician or any expert on a -- you know, on epidemiology or infectious medicine, whether your opinion is correct or not? 

A. That’s not my opinion, that’s the – that’s what’s outlined in CDC and CMS droplet precaution standards. 

Q. All right.  So if we assume that this nurse washed her hands, what was the potential for harm to this resident? 

A. So if she had been carrying COVID-19 and was an asymptomatic carrier, if she’s not wearing gloves and she’s preparing medications, and she’s standing at the medication cart, looking down, getting everything ready, if, if she’s not wearing gloves, then she has the potential to spread any kind of contaminates to that resident or bring them out into the room after she leaves if she did not do hand hygiene. 

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Tr. I at 123-24. 

I find that LPN2 failed to comply with Petitioner’s IPCP because LPN2 did not wear gloves when administering medication to a resident.  However, I do not find that LPN2 was in violation of the IPCP by wearing a facemask instead of a respirator when not providing care to a resident. 

Although CMS cites training provided to staff in April 2020 as the basis for saying that LPN2 failed to properly wear a respirator mask, the training only stated that staff working on the third floor had to wear PPE while on the third floor.  P. Ex. 36 at 44; CMS Ex. 3 at 6.  A facemask is considered PPE and the training information did not specify that a respirator was necessary.  As indicated earlier in this decision, the IPCP requires a respirator when staff are providing care to residents.  There is no reason to believe that LPN2 was providing care when observed with the facemask.  Interestingly, shortly after the observation of LPN2 with a facemask, the surveyor observed LPN2 go to a resident to administer medication and LPN2 was wearing a respirator at that time.  CMS Ex. 1 at 7. 

However, there is also no doubt that LPN2 was required to wear gloves when providing care to a resident by providing the resident with a medication.  The IPCP provides for “additional” infection control recommendations for suspected cases in the facility.  These include implementing universal source control (facemask or face coverings) while in the facility; wearing full PPE per CDC guidelines for the care of any resident with known or suspected COVID-19; and wearing all recommended COVID-19 PPE for the care of residents on an affected unit (or facility-wide if cases are widespread), including both symptomatic and asymptomatic residents.  CMS Ex. 2 at 37.  CDC’s April 13, 2020 revised guidelines make it clear that both hand hygiene and wearing gloves is necessary when having contact with residents who are suspected of having COVID-19.  P. Ex. 15 at 5-7. 

Petitioner asserts that LPN2’s failure to wear gloves when administering medication to a resident could not pose the risk of more than minimal harm to residents so long as LPN2 washed her hands before taking the medication to the resident.  Petitioner points out that the surveyor did not see whether LPN2 washed her hands.  However, this does not mean that Petitioner prevails on this argument.  The surveyor’s observation of LPN2’s failure to wear gloves is enough to make a prima facie showing of a deficiency, and it was then incumbent on Petitioner to show substantial compliance.  As mentioned above, Petitioner did not provide written testimony from LPN2 or other evidence that LPN2 washed her hands before taking the medication to the resident.  Given that LPN2 failed to follow the IPCP and wear gloves, there is no reason for me to presume that LPN2 had washed her hands. 

Finally, I find that LPN2’s failure to wear gloves while administering medications to a resident with suspected COVID-19 presented a risk for more than minimal harm.  There

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is no evidence that LPN2 washed her hands before providing a medication to a resident without gloves on her hands.  I accept the surveyor’s testimony as to the potential risk. 

5. On May 14, 2020, Nurse Aide (NA1) returned to the third floor after escorting a resident out of the building for a medical appointment.  NA1 disposed of her PPE after leaving the resident and returned to the third floor with only a facemask.  NA1 walked from the elevator, past the nurse’s station and into an office.  Although NA1 violated training she received in April 2020 to wear PPE when on the third floor, she did not violate the IPCP because the IPCP only required full PPE when providing resident care.  NA1 fulfilled the general requirement to wear a facemask in the facility while not providing resident care.  Therefore, NA1 did not violate the IPCP. 

The SOD alleged the following incident occurred: 

On 5/14/2020 at 9:15am, Nurse Aide (NA1) exited the elevator onto the 3rd floor.  NA1 walked from the elevator, past the nursing station, and to an empty office area.  NA1 wore a disposable surgical mask, but failed to wear any other PPE.  At 9:20am, NA1 indicated that she escorted a resident downstairs to the transportation van, disposed of her other PPE, and had failed to don more before entering the 3rd floor. 

CMS Ex. 1 at 6-7.  

CMS argues that NA1 violated the IPCP because NA1 did not don full PPE upon entering the third floor of the facility, which had residents suspected of having COVID-19 living there.  CMS Br. at 18.  In support of CMS’s position, the surveyor testified to the facts alleged in the SOD.  CMS Ex. 29 ¶ 13d.  Further, the surveyor testified that NA1 violated Petitioner’s IPCP because she failed to don full PPE entering the third floor of the facility.  Tr. I at 117.  The surveyor indicated that a facility staff member had tested positive for COVID-19 a few days earlier, thus making the use of PPE more necessary.  Tr. I at 120-21.  

Petitioner argues that NA1’s actions posed no potential for more than minimal harm because there were no confirmed cases of COVID-19 in the facility.  P. Br. at 36.  The Medical Director and a facility nurse testified that NA1 simply returning from escorting a resident out of the building and walking past the nurse’s station to an office wearing only a facemask did not violate CDC infection control guidelines.  P. Ex. 48 at 12; Tr. II at 44; P. Ex. 50 at 5. 

In April 2020, Petitioner trained its employees as follows: 

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Infection control practice.  All staff working on the 3rd and 4th floor will don PPE upon arrival to unit.  All staff will keep PPE on the entire time on the unit.  PPE will be removed prior to leaving the unit.  Staff working the above mentioned unites will not be allowed on any other unit. 

P. Ex. 36 at 44; CMS Ex. 3 at 6.  However, as explained in detail earlier in this decision, the IPCP only required full PPE when staff were providing care for residents.  Further, as indicated earlier in this decision, staff had to wear facemasks while in the facility. 

NA1 was observed with a facemask walking from an elevator into an office.  This does not provide sufficient evidence that NA1 violated the IPCP or posed more than minimal harm to residents. 

14. Petitioner failed to be in substantial compliance with 42 U.S.C. § 1395i-3(d) and 42 C.F.R. § 483.80(a)(1)-(2) because on May 14, 2020, Petitioner’s staff failed to maintain/implement Petitioner’s IPCP concerning the use of PPE. 

CMS alleges that Petitioner did not comply with the following Medicare program requirement for SNFs: 

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); 42 C.F.R. § 483.80.  As stated previously, it is not enough for an SNF to establish an IPCP, the SNF must implement that IPCP.  Golden Living Ctr. – Superior, DAB No. 2768 at 7; Heritage House, DAB No. 2566 at 12. 

As demonstrated above, Petitioner failed to fully implement its IPCP concerning staff use of PPE.  I detailed findings that LPN1 failed to wear a mask at all times in the facility and that LPN1’s lowering of her mask to speak to the surveyor and her failure to keep a mask on, an hour later, while working at the nurse’s station computer manifested an indifference or resistance to implementing the IPCP.  I also found that such conduct, done within view of a surveyor, presented a risk of more than minimal harm to residents.  LPN1 was unconcerned that speaking with the surveyor maskless might result in contracting COVID-19. 

Further, I found that LPN2 failed to implement the IPCP when she administered medication to a resident while not wearing gloves.  Because Petitioner did not show that

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LPN2 had otherwise engaged in hand hygiene, I found that LPN2’s actions caused a risk of more than minimal harm to residents. 

Finally, I found that M1’s failure to change her gloves after cleaning one resident room and starting to clean another was a violation of the IPCP.  Given that M1 was required to clean bathroom toilets as well as bed tables, bed rails, and call buttons, I found that M1’s exposure to infectious materials (i.e., fecal matter) posed a risk of more than minimal harm to residents. 

Therefore, based on the above, I conclude that Petitioner was not in substantial compliance with 42 U.S.C. § 1395i-3(d)(3)(A) and 42 C.F.R. § 483.80. 

Enforcement Remedies

15. Petitioner did not timely request a hearing to dispute the DPNA that CMS imposed on Petitioner from May 21, 2020 through May 25, 2020; therefore, that enforcement remedy is binding on Petitioner.  CMS Ex. 24 at 2. 
16. The amount and duration of the $6,525 per-day CMP imposed from March 11, 2020 through May 25, 2020, were not challenged and are, therefore, reasonable.

CMS imposed a $6,525 per-day CMP on Petitioner from March 11, 2020 through May 25, 2020.  CMS Ex. 25 at 1.  Petitioner disputed the deficiency underlying the imposition of this penalty, 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). 

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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). 

In its post-hearing brief, CMS argues that Petitioner has failed to raise or meet its burden to challenge the reasonableness of the CMP, other than a brief statement in the hearing request.  CMS Br. at 25.  CMS further argues that it is not under an obligation to submit evidence as to the regulatory factors concerning the CMP amount.  CMS Br. at 26.  In its post-hearing brief, Petitioner did not respond to CMS’s assertion that Petitioner has neither challenged the reasonableness of the CMP amount nor the duration of the CMP.  Further, Petitioner’s post-hearing brief does not raise arguments as to the amount and duration of the CMP.¹² 

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I agree with CMS.  I note that in my April 14, 2023 Order concerning the issues in the case, I gave the parties an opportunity to provide any additional arguments that they may have as to the amount of the CMP in this case.  While Petitioner responded to the Order, Petitioner did not avail itself of the opportunity to dispute the amount of the CMP imposed by CMS.  Therefore, I consider the $6,525 per-day from March 11, 2020 through May 25, 2020, CMP to be reasonable. 

V.    Conclusion

Petitioner was not in substantial compliance with 42 C.F.R. § 483.80(a)(1)-(2).  Therefore, Petitioner is appropriately subject to a DPNA from May 21, 2020 through May 25, 2020, and a $6,525 per-day CMP from March 11, 2020 through May 25, 2020. 

---

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, chap. 7, § 7400.5 (Sep. 10, 2010).  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 indicate deficiencies that involve actual harm that do not amount to immediate jeopardy.  Scope and severity levels J, K, and L are deficiencies that constitute immediate jeopardy to resident health or safety. 

⁴   Petitioner’s witnesses included three physicians.  Julie K. Gammack, M.D., is the facility’s Medical Director.  She is Board Certified in Geriatrics and Internal Medicine and is a Certified Long Term Care Medical Director.  She is on the faculty of the Saint Louis University School of Medicine, where she serves as Interim Director of the Division of Geriatric Medicine.  P. Ex. 48 at 1.  Morgan Katz, M.D., is one of Petitioner’s expert witnesses.  She is an Assistant Professor in the Department of Medicine at Johns Hopkins University Hospital.  P. Ex. 54 at 8.  From 2011 to 2014, Dr. Katz completed a fellowship in infectious diseases at Johns Hopkins University and now serves on the infectious disease faculty at Johns Hopkins.  P. Ex. 54 at 8.  Peter A. Hashisaki, M.D., is another expert witness for Petitioner.  He has been Board Certified in Infectious Diseases since 1982 and practiced infectious disease medicine for many years.  P. Ex. 52 at 1. 

⁵  Separate transcripts were produced for each day of the hearing.  Each transcript starts at page 1.  Therefore, I cite the March 24 transcript as Tr. I at [page number] and the transcript for March 25 as Tr. II at [page number]. 

⁶   This provision of the Act is made applicable to the present case through cross-references in 42 U.S.C. §§ 1320a-7a(j)(1), 1395i-3(h)(2)(B)(ii)(I).  

⁷  As indicated above, Petitioner’s counsel at first stated that he had not been able to find Ms. Branch.  Tr. I at 7.  Then he characterized Ms. Branch’s absence from the hearing as being unavailable for unknown reasons.  These statements were made in support of a request that I admit Ms. Branch’s written direct testimony into the record even though CMS could not cross-examine Ms. Branch.  Only when asked directly did Petitioner’s counsel explain that Petitioner’s Administrator had contacted Ms. Branch when counsel first started to prepare for the hearing and that Ms. Branch indicated an unwillingness to testify.  Tr. I at 15-16.  The initial statement, that Petitioner’s counsel could not locate Ms. Branch, is starkly different than the later statement that Petitioner’s Administrator had been able to contact Ms. Branch and Ms. Branch said that she was unwilling to participate.  Further, Petitioner’s Administrator had no difficulty contacting and speaking with Ms. Branch on the evening of the first day of the hearing after I excluded Ms. Branch’s written direct testimony, showing that Petitioner knew how to contact Ms. Branch.  Ethical rules prohibit attorneys from making false statements to a tribunal and such conduct can subject the attorney to sanctions.  Model Rules of Prof’l Conduct R. 3.3(a); 42 U.S.C. § 1320a-7a(c)(4) (made applicable to this case by 42 U.S.C. § 1395i-3(h)(2)(B)(ii)(I)). 

⁸  Although the SOD cited Tag F-880 as the basis for the deficiency, which encompasses the Medicare program requirements at 42 C.F.R. § 483.80(a)(1), (2), (4), (e) and (f), CMS expressly based the CMP only on noncompliance with 42 C.F.R. § 483.80(a)(1) and (2).  CMS Ex. 1 at 1-3; CMS Ex. 25 at 1. 

⁹  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 and 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.”).  

¹⁰  The SOD noted that the facility experienced an outbreak of COVID-19 in late-March 2020, in which 41 residents were COVID-19 positive.  The SOD stated that seven of those residents died.  The SOD does not explicitly state the reason for the outbreak, and the record does not clearly establish that Petitioner’s screening of staff caused the outbreak.  CMS Ex. 1 at 4.  Petitioner’s witnesses testified consistently with the SOD’s statements but included the fact that ten staff members tested positive for COVID-19 as well.  P. Ex. 47 at 10; P. Ex. 48 at 9.  Petitioner’s Administrator and Medical Director testified that they thought it likely that COVID-19 was introduced into the facility at the end of March 2020 by three residents who had being going out of the facility for kidney dialysis.  These three residents were admitted to a hospital and tested positive for COVID-19 on March 23, 2020.  P. Ex. 47 at 8; P. Ex. 48 at 8-9; P. Ex. 50 at 3; Tr. I at 186-88.  After these residents tested positive, it was determined that other residents were also infected with COVID-19.  Tr. I at 186-87.  Drs. Katz and Hashisaki testified that an outbreak caused by residents who left the facility for dialysis was consistent with outbreaks at other SNFs.  P. Ex. 52 at 8; P. Ex. 54 at 4-5.  It is interesting that despite Petitioner’s representation that staff screening was essentially useless, Petitioner does not believe that the COVID-19 outbreak at the facility was caused by asymptomatic staff who brought the virus into the facility despite being screened. 

¹¹  For purposes of this portion of the decision, I do not credit Dr. Hashisaki’s opinion that “most” of the observed practices by Petitioner’s staff during the survey were either not violations of CDC infection control guidelines or, if they were, failed to pose any plausible risk of infection.  P. Ex. 52 at 12.  Although Dr. Hashisaki’s written testimony is nearly 13 pages long, he devoted approximately only half a page (spread over portions of three pages) to discussing the many incidents noted during the survey.  P. Ex. 52 at 12-14.  As a result, his opinions concerning the specific observations of staff in the SOD are cursory and conclusory.  I also note that while Dr. Hashisaki spent much of his testimony stating that COVID-19 is highly contagious and that, at the time of the survey, there were few effective means for SNFs to protect residents, Dr. Hashisaki dismisses out of hand “most” of the surveyor’s concerns about staff action during the survey. 

¹²  Petitioner briefly challenged the two allegations in the SOD issued following the May 21, 2020 revisit survey; however, Petitioner discussed one of those allegations as if it were part of the SOD related to the May 14-18, 2020 survey and the other allegation in a footnote.  P. Br. at 36-37; P. Br. at 37 n.9.  I do not consider these references to the allegations in the SOD concerning the May 21, 2020 survey to constitute a challenge to the duration of the CMP.  However, if they could be construed as a challenge to the duration of the CMP, I conclude that Petitioner did meet its burden to show that it returned to substantial compliance with 42 C.F.R. § 483.80.  Petitioner did not present evidence concerning the allegations in the SOD (e.g., Petitioner neither included testimony from facility witnesses nor its expert witnesses).  Further, Petitioner’s argument concerning one of the allegations (i.e., a restorative aide was seen exiting a resident’s room without gloves and wearing two facemasks rather than a respirator mask (CMS Ex. 19 at 3)) incorrectly stated that the surveyor admitted on cross-examination that the allegation presented no plausible potential risk of harm risk when the surveyor only testified that she was unaware of research that showed there would be a risk of harm when wearing two facemasks.  See Tr. I at 127.  The surveyor also testified as follows concerning this allegation: “As confirmed with the facility administrator, the abatement plan included wearing full PPE with all residents, which would include gloves and N95 respirator, if available.  The [DON] further confirmed on the day of the survey that N95 respirator was expected of staff when working with residents, not two surgical masks.” CMS Ex. 29 ¶ 29a.  Concerning the second allegation (i.e., a resident exited an elevator on the fourth floor of the facility alone (CMS Ex. 19 at 4), Petitioner asserts that there was no potential that the resident could infect anyone in the facility by moving through the facility, unescorted, following a return from dialysis at an outside the facility.  P. Br. at 37 n.9.  The surveyor testified to the risk posed by the situation: “Residents who left the facility were to be isolated upon returning to the facility.  Without staff escorts[,] the facility had no way to know if the resident complied with isolation requirements.” CMS Ex. 29 ¶ 29b.  Petitioner’s abatement plan, with which Petitioner alleged compliance on May 19, 2020, indicated that residents returning from essential medical appointments will remain on standard and droplet precautions for 14 days after each appointment.  CMS Ex. 23 at 1.  This was consistent with facility policy.  P. Ex. 47 at 11; P. Ex. 50 at 3.  Considering that Petitioner posits, as discussed above, in this proceeding that its large outbreak of COVID-19 was likely caused by residents who had returned from dialysis appointments at outside facilities, the risk of a resident moving about the facility unescorted following a dialysis appointment is obvious.