Crossroads Care Center, DAB CR6799 (2025)

DECISION

Crossroads Care Center (Petitioner or facility) is a skilled nursing facility (SNF) that participates in the Medicare program.  During the coronavirus disease of 2019 (COVID or COVID-19) pandemic, the Minnesota Department of Health (state agency or MDH) conducted surveys of the facility and found that Petitioner was not in substantial compliance with Medicare program participation requirements because it failed to:  1) fully implement its COVID infection control program (ICP) when it did not place residents exposed to a COVID-positive staff member or residents manifesting symptoms for COVID-19 on transmission-based precautions; 2) timely inform the families/representatives of all facility residents when one or more residents tested COVID-positive; and 3) suspend facility employees alleged to have abused/neglected residents pending investigation of those allegations and failed to timely inform the state agency of the allegations of abuse and/or neglect.  The state agency also concluded that Petitioner’s failure to implement the COVID ICP immediately jeopardized the health and safety of facility residents.

The Centers for Medicare & Medicaid Services (CMS) adopted the state agency’s findings of noncompliance and imposed remedies on Petitioner to ensure a return to

Page 2

substantial compliance, including a denial of payment for new admissions (DPNA) and a civil money penalty (CMP).  Petitioner requested a hearing before an administrative law judge (ALJ) to dispute the deficiencies involving the alleged failures to fully implement its COVID ICP and timely inform families/representatives whenever a resident tested COVID-positive.  Petitioner also challenged the alleged duration of its noncompliance and the immediate jeopardy finding.  Petitioner did not challenge the deficiency related to the complaints of resident abuse/neglect.

I affirm CMS’s determination that Petitioner was noncompliant with the Medicare program participation requirements as identified by the state agency.  However, I disagree that the record supports all of the factual instances of alleged noncompliance.  Further, I conclude that CMS’s determination that Petitioner immediately jeopardized the health and safety of residents is not clearly erroneous and that Petitioner did not successfully show a return to substantial compliance earlier than the date found by CMS.  Finally, I affirm the duration of the enforcement remedies and the amounts of the CMPs that were imposed.

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 the age of 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).

A Medicare participating SNF must meet a variety of ongoing statutory requirements as to how it provides services, maintains the rights of its residents, and administers its facility.1  42 U.S.C. § 1395i-3(a)(3), (b)-(d).  Further, SNFs must comply with “such

Page 3

other requirements relating to the health, safety, and well-being of residents or relating to the physical facilities thereof as the Secretary may find necessary.”  42 U.S.C. § 1395i-(d)(4)(B); see 42 U.S.C. § 1395i-3(c)(1)(xi), (f).  The Secretary has 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 also 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; see also 42 U.S.C. § 1395i-3(h)(3).  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.

“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).  To do so, the Secretary contracts with state agencies to survey participating SNFs.  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 investigate complaints made against SNFs.  42 U.S.C. § 1395i-3(g)(1)(C), (4).

When the results of a survey or investigation show that an SNF is not in substantial compliance with Medicare program participation requirements, the Secretary may impose remedies on the SNF.  42 U.S.C. § 1395i-3(h)(2); 42 C.F.R. § 488.406.  All remedies imposed on SNFs are remedial in nature because they “ensure prompt compliance with

Page 4

[Medicare] program requirements” and “are applied on the basis of noncompliance found during surveys conducted by CMS or by the survey agency.”3  42 C.F.R. § 488.402(a)-(b); NMS Healthcare of Hagerstown, DAB No. 2603 at 8 n.6 (2014) (holding that, although the regulations use the term “civil money penalty,” the regulations also “make it clear that a CMP is not a punitive mechanism.”).  In order to assist a facility in returning to substantial compliance quickly, SNFs must file a plan of correction with the state agency/CMS.  42 C.F.R. § 488.402(d).

When CMS selects a 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.  See 42 C.F.R. § 488.404(a)-(b).  The highest level of severity occurs when the noncompliance immediately jeopardizes the health or safety of SNF residents.  See 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.

One enforcement remedy is a DPNA.  CMS must impose a DPNA within three months of an SNF failing to be in substantial compliance with Medicare requirements for SNFs.  42 U.S.C. § 1395i-3(h)(2)(D); 42 C.F.R. § 488.417(b).  CMS may also impose a DPNA whenever an SNF is noncompliant with Medicare requirements.  42 C.F.R. § 488.417(a).  If the SNF does not have repeated instances of substandard quality of care, CMS payments resume prospectively on the date that the facility achieves substantial compliance with Medicare requirements either based on a revisit survey or credible written evidence that is acceptable to CMS.  42 C.F.R. § 488.417(d).

Another enforcement 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 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 noncompliance that poses immediate jeopardy to the health and safety of residents.

Page 5

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) (CMP ranges before statutory inflation adjustments).

If CMS imposes a CMP based on a finding of noncompliance, then the SNF may request a hearing before an ALJ to challenge CMS’s initial determination of noncompliance that led to the imposition of a 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 such a showing is made, the SNF must then prove substantial compliance by a preponderance of the evidence.  Hillman Rehab. Ctr., DAB No. 1611 at 8 (1997), aff’d, Hillman Rehab. Ctr. v. U.S. Dep’t of Health & Hum. Servs., No. Civ.A. 98-3789 (GEB), 1999 WL 34813783 (D.N.J. May 13, 1999); 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 the CMP amount.  42 C.F.R. § 488.438(e)(3); see 42 U.S.C. §§ 1320a-7a(d), 1395i-3(h)(2)(B)(ii)(I); 42 C.F.R. § 488.438(f).  The ALJ may not reduce a CMP to zero.  42 C.F.R. § 488.438(e)(1).

Either the SNF or CMS may request that the Departmental Appeals Board (DAB) review an ALJ’s decision.  42 C.F.R. § 498.80; see also 5 U.S.C. § 557.

II.  Background and Procedural History

Petitioner is an SNF located in Worthington, Minnesota.  From October 28, 2020 through November 2, 2020, the state agency conducted both an abbreviated survey to investigate complaints made against the facility and a COVID-19 Focused Infection Control Survey.  CMS Ex. 1 at 1.  The state agency issued a Statement of Deficiencies (SOD) alleging noncompliance with the following Medicare program requirements:

• 42 C.F.R. § 483.12(b)(1)-(3) (F-Tag 607) (S/S = D) (Develop/Implement Abuse/Neglect Policies).

Page 6

• 42 C.F.R. § 483.12(c)(1)-(4) (F-Tag 609) (S/S = D) (Reporting of Alleged Violations).
• 42 C.F.R. § 483.80(a)(1), (2), (4), (e), (f) (F-Tag 880) (S/S = L) (Infection Prevention and Control).

CMS Ex. 1.  Further, the state agency determined that the Infection Prevention and Control deficiency immediately jeopardized the health and safety of residents from September 17, 2020 until October 30, 2020.  CMS Ex. 1 at 1-2, 9-10.  However, the state agency also determined that, while the immediate jeopardy situation had ended before the SOD was issued, Petitioner was still not in substantial compliance with Medicare program requirements for SNFs.  CMS Ex. 1 at 10.

In a November 20, 2020 notice of initial determination, the state agency notified Petitioner that CMS authorized the imposition of a discretionary DPNA, effective December 5, 2020, and a directed plan of correction (DPOC).  CMS Ex. 2 at 1.  The state agency also recommended that CMS impose a CMP on Petitioner.  CMS Ex. 2 at 1-2.

The state agency conducted another COVID-19 Focused Infection Control Survey at the facility on November 24-25, 2020, and found Petitioner noncompliant with the following Medicare participation requirement for SNFs:

• 42 C.F.R. § 483.80(g)(3)(i)-(iii) (F-Tag 885) (S/S = F) (Reporting-Residents, Representatives & Families).

CMS Ex. 3.  In a December 11, 2020 notice, the state agency stated that:  1) Petitioner was still noncompliant with Medicare program participation requirements; 2) the DPNA was effective on December 5, 2020; 3) the DPOC was still imposed; and 4) the imposition of a CMP was still being recommended to CMS.  CMS Ex. 4 at 1.  In a January 3, 2021 notice, the state agency stated that it completed a revisit survey on December 30, 2020, and determined that Petitioner achieved substantial compliance with Medicare program participation requirements as of December 30, 2020; therefore, the DPNA was discontinued on December 30, 2020.  CMS Ex. 5 at 1.

In a May 21, 2021 notice, CMS imposed the following CMPs on Petitioner:

• $22,320 per-day CMP for 3 days, from October 27, 2020 through October 29, 2020, for a total of $66,960.
• $435 per-day CMP for 61 days from October 30, 2020 through December 29, 2020 for a total of $26,535.

Page 7

CMS Ex. 6 at 2.  CMS also stated that the DPOC was imposed and completed, and the DPNA was effective December 5, 2020, through December 29, 2020.  CMS Ex. 6 at 2.

On June 7, 2021, Petitioner requested a hearing before an ALJ to dispute the imposition of enforcement remedies.  On June 8, 2021, the Civil Remedies Division acknowledged receipt of the hearing request and issued my Standing Prehearing Order.

On September 21, 2021, CMS filed a prehearing brief and motion for summary judgment as well as 57 proposed exhibits (CMS Exs. 1-57).  Two of the exhibits were written direct testimony from witnesses (CMS Exs. 56-57).  On October 26, 2021, Petitioner submitted a prehearing brief and cross-motion for summary judgment and 18 proposed exhibits (P. Exs. 100-117).  Three of the exhibits were written direct testimony from witnesses (P. Exs. 100-103).  The parties requested to cross-examine each other’s witnesses.

On October 26, 2022, I issued a Notice of Hearing in which I set a hearing for February 8-9, 2023, to permit the parties to cross-examine the witnesses in this case.  In the notice, I denied the parties’ summary judgment motions and admitted, without objection, all of the parties’ proposed exhibits into the record.  Based on an unopposed motion from CMS, on November 9, 2022, I rescheduled the hearing for March 15, 2023.

On March 15, 2023, I held a hearing at which the parties cross-examined the opposing party’s witnesses.  Hearing Transcript (Tr.) 17-152.  At the hearing, I excluded CMS Exhibit 58, which CMS filed the previous day, because it was untimely filed without good cause.  Tr. 5-8; see also Civil Remedies Division Procedures § 13(d).  At the end of the hearing, I directed the parties to file post-hearing briefs and required the parties to provide, in those briefs, all arguments that they wanted me to consider when rendering this decision.  Tr. 156-57; May 8, 2023 Notice of Receipt of Transcript and Post-Hearing Briefing Schedule at 1.  In September and October 2023, the parties filed post-hearing briefs (CMS Br. and P. Br.) and CMS filed a reply brief (CMS Reply).

III.  Issues

1. Whether Petitioner was in substantial compliance with 42 C.F.R. §§ 483.80(a)(1)-(2) and/or 483.80(g)(3)(i)-(iii).
2. Whether CMS’s determination that Petitioner immediately jeopardized the health and safety of its residents is clearly erroneous.
3. Whether a $22,320 per-day CMP for 3 days and a $435 per-day CMP for 61 days is reasonable under relevant statutory and regulatory factors.

Page 8

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

The findings of fact and conclusions of law (FFCL) are set out in bold and italics with supporting findings and conclusions below the bolded and italicized text.

Abuse and Neglect

1. The state agency found that Petitioner was not in substantial compliance with 42 C.F.R. § 483.12(b)(1)-(3), (c)(1), (4) when it failed to suspend staff members alleged to have abused/neglected residents pending the outcome of the investigation and did not timely report the allegations of resident abuse/neglect to the state agency.  Petitioner did not dispute these findings.

SNF residents have the right to be free from physical or mental abuse, and SNF residents have the right to file complaints of abuse and neglect with the relevant state survey agency.  42 U.S.C. § 1395i-3(c)(1)(A)(ii), (B).  The relevant state survey agency will timely review and investigate allegations of abuse and neglect by SNF staff.  42 U.S.C. § 1395i-3(g)(1)(C).

In the present case, the state agency received allegations of resident abuse/neglect, and the state agency investigated those allegations.  CMS Ex. 1 at 1.  The state agency concluded that Petitioner was not in substantial compliance with 42 C.F.R. § 483.12(b)(1) and (c)(1), (4), because Petitioner failed to suspend staff, who allegedly abused/neglected residents, pending the completion of a facility investigation and failed to report the allegations of abuse/neglect to the state agency in a timely manner.  CMS Ex. 1 at 2-7.  Those regulations state the following:

(b) The facility must develop and implement written policies and procedures that:

(1) Prohibit and prevent abuse, neglect, and exploitation of residents and misappropriation of resident property,

* * * * *

(c) In response to allegations of abuse, neglect, exploitation, or mistreatment, the facility must:

(1) Ensure that all alleged violations involving abuse, neglect, exploitation or mistreatment, including injuries of unknown source and misappropriation of resident property, are reported immediately, but not later than 2 hours after the allegation is made, if the events that cause the allegation involve abuse or

Page 9

result in serious bodily injury, or not later than 24 hours if the events that cause the allegation do not involve abuse and do not result in serious bodily injury, to the administrator of the facility and to other officials (including to the State Survey Agency and adult protective services where state law provides for jurisdiction in long-term care facilities) in accordance with State law through established procedures.

* * * * *

(4) Report the results of all investigations to the administrator or his or her designated representative and to other officials in accordance with State law, including to the State Survey Agency, within 5 working days of the incident, and if the alleged violation is verified appropriate corrective action must be taken.

42 C.F.R. § 483.12(b)(1), (c)(1), (4).

The state agency surveyors obtained Petitioner’s policies on abuse/neglect and confirmed that Petitioner’s staff was to investigate alleged occurrences of abuse and neglect.  CMS Ex. 1 at 4; CMS Ex. 11 at 2, 7.  Those policies also required Petitioner to immediately suspend staff who were suspected or accused of resident abuse pending the outcome of the investigation.  CMS Ex. 1 at 5; CMS Ex. 11 at 3, 8.  Finally, those policies required Petitioner’s staff to immediately report any observed or suspected abuse to the facility Administrator or the Director of Nursing Services or, in the absence of the Director of Nursing (DON), the Nurse Supervisor on duty.  CMS Ex. 11 at 2.  Consistent with 42 C.F.R. § 483.12(c)(1), Petitioner’s policy was that “[a]ll allegations of abuse will be reported immediately, but not later than 2 hours after the allegation is made, if the events that cause the allegation involve abuse or result in serious bodily injury, or not later than 24 hours if the events that cause the allegations do not involve abuse and do not result in serious bodily injury.”  CMS Ex. 11 at 3.

The state agency’s survey results indicated that “the facility failed [to] immediately suspend 3 of 3 staff, licensed practical nurse (LPN)-A, nurse aide (NA)-A and NA-B pending investigation after allegations of abuse and neglect were received for 2 of 3 residents (R1 and R3).”  CMS Ex. 1 at 3.  The specific facts found during the survey included:

• On August 2, 2020, an activity aide observed LPN-A yell at R1 and tell him he had to wait until after lunch to sit in his recliner and be changed.  R1 had repeatedly requested assistance.  LPN-A pushed R1 to his room and closed the door.  CMS Ex. 1 at 3; see also CMS Ex. 13 at 4-6.

Page 10

• On August 5, 2020, a staff member noticed that R1’s “grabber” was hanging from the privacy curtain track.  When asked, R1 stated that NA-A put it there “so he could not mess with things.”  CMS Ex. 1 at 3; see also CMS Ex. 13 at 17-18.
• The facility investigated LPN-A and NA-A, but neither was suspended prior to the completion of the investigation.  CMS Ex. 1 at 3; see also CMS Ex. 13 at 15.
• On August 8, 2020, R3 stated that NA-B would not let R3 take her coloring book to the dining room to color before meals, did not assist her to turn on the television, and did not assist her to the bathroom causing her to sit in a soaked brief the entire day.  A report indicated that NA-B was given a verbal warning.  CMS Ex. 1 at 3-4; see also CMS Ex. 15 at 1, 3.
• NA-B was not suspended pending the outcome of an investigation.  CMS Ex. 1 at 4; see also CMS Ex. 15 at 4, 9.

The state agency’s survey results also indicated that the “facility failed to report allegations of abuse or neglect for 2 of 3 residents (R1 and R3) to the State Agency.”  CMS Ex. 1 at 6.  The specific facts found during the survey included:

• The August 2, 2020 incident involving LPN-A and R1, the August 5, 2020 incident involving NA-A and Resident 1, and October 8, 2020 incident involving NA-B and R3, were not reported to the state agency.  CMS Ex. 1 at 6.

Petitioner did not report the incidents involving R1 and R3 to the state agency until October 29, 2020, the day after the state agency survey began.  CMS Ex. 13 at 11-16; CMS Ex. 15 at 5-9.

When I notified the parties about the issues to be decided in this case, I stated that Petitioner did not discuss the deficiencies under 42 C.F.R. § 483.12(b)(1) and (c)(1), (4) in prehearing briefing and that I no longer considered those deficiencies to be in dispute.  Notice of Hr’g at 3.  I provided the parties with ten days to object (Notice of Hr’g at 6); however, Petitioner did not do so.  Further, Petitioner did not object when I stated at the hearing that these deficiencies were not contested.  Tr. 162.

Because Petitioner did not dispute the facts alleged by the state agency or dispute the finding of noncompliance with 42 C.F.R. § 483.12(b)(1), (c)(1), (4), those findings are final and binding.  42 C.F.R. § 498.20(b); see also CMS Ex. 56 ¶¶ 6-7.

Page 11

Infectious Disease Control and Prevention Deficiency

2. In 2020, COVID-19 was a highly contagious virus that was especially dangerous to the elderly.  Age was a strong risk factor for severe COVID-19 illness, complications, and death.  Further, COVID-19 spread easily in the nursing home environment due to the number of individuals living together in a facility who have underlying chronic medical conditions.  The CDC found that a strong ICP was critical to protect nursing home residents. 

In December 2019, COVID-19 was detected in China.  By January 30, 2020, the World Health Organization declared the COVID-19 outbreak to be a “Public Health Emergency of International Concern,” and on January 31, 2020, the Secretary declared COVID-19 to be a public health emergency in the United States.  P. Ex. 104 at 1-2.  The Secretary stated that, “COVID-19 is an acute respiratory disease caused by the SARS-CoV-2 betacoronavirus or a virus mutating therefrom.”  P. Ex. 104 at 1.

In May 2020, the Centers for Disease Control and Prevention (CDC) stated:  “COVID-19 seems to spread more easily than flu and causes more serious illnesses in some people.  It can also take longer before people show symptoms and people can be contagious for longer.”  CMS Ex. 47 at 2.  A CDC document entitled “Preparing for COVID-19 in Nursing Homes,” updated on June 25, 2020, stated that “nursing home populations are at high risk of being affected by respiratory pathogens like COVID-19” because those populations live in “congregate” settings and the nursing home resident population is “older adults often with underlying chronic medical conditions.”  CMS Ex. 48 at 1.

This assessment is consistent with CDC’s stated concerns about the elderly related to  COVID-19.  In a CDC document updated May 13, 2020, it says that “[o]lder adults and people who have severe underlying medical conditions like heart or lung disease or diabetes seem to be at higher risk for developing more serious complications from COVID-19 illness.”  CMS Ex. 47 at 1 (Emphasis omitted).  In a document updated in October 2020, the CDC stated that age is a strong risk factor for severe illness, complications, and death, with the fatality rate highest among older persons.  CMS Ex. 50 at 3.  The CDC determined that “a strong infection prevention and control (IPC) program is critical to protect both [nursing home] residents and healthcare personnel (HCP).”  CMS Ex. 48 at 1.

3. In 2020, COVID-19 had an incubation period of 14 days.

The CDC stated in documents updated in May 2020 and October 2020, that the incubation period for COVID-19 is up to 14 days.  CMS Ex. 47 at 1; CMS Ex. 50 at 2.

Page 12

4. In 2020, symptoms for COVID-19 included cough, shortness of breath or difficulty breathing, congestion, fatigue, muscle or body aches, headache, nausea, vomiting, or diarrhea.

In May 2020 and October 2020, CDC guidance documents provided the following list of symptoms for COVID-19, which may range from mild to severe:

• Fever or chills
• Cough
• Shortness of breath or difficulty breathing
• Fatigue
• Muscle or body aches
• Headache
• New loss of taste or smell
• Sore throat
• Congestion or runny nose
• Nausea or vomiting
• Diarrhea

CMS Ex. 47 at 1; CMS Ex. 50 at 2.  To these symptoms, the Mayo Clinic also stated that other COVID-19 symptoms include:

• Skin changes (a red rash with small bumps, discolored areas on the fingers and toes, and hives)
• Severe confusion (delirium)
• Eye problems (pink eye, light sensitivity, sore eyes, and itchy eyes)

CMS Ex. 107 at 2.

In a June 25, 2020 document, the CDC stated that “[o]lder adults with COVID-19 may not show common symptoms such as fever or respiratory symptoms.”  CMS Ex. 48 at 5.  The “[l]ess common symptoms” can include new or worsening:

• Malaise
• Headache
• New dizziness
• Nausea
• Vomiting
• Diarrhea
• Loss of taste or smell 

Page 13

CMS Ex. 48 at 5.  The CDC stated the “[i]dentification of these symptoms should prompt isolation and further evaluation for COVID-19.”  CMS Ex. 48 at 6.

The CDC stated that older adults and persons with medical comorbidities may have delayed presentation of fever and respiratory symptoms.  CMS Ex. 50 at 2.

5. The state agency’s system for health care providers to report COVID-19 infections defined diarrhea as three episodes of loose stool within a 24-hour period.  This is the medical definition of diarrhea.

The state agency’s system for reporting possible COVID-19 infections was called REDCap.  Tr. 41; P. Ex. 101 ¶ 7.  REDCap defines symptomatic diarrhea as three or more episodes of loose stools within a 24-hour period.  P. Ex. 101 ¶ 8; Tr. 42, 111-12, 146.  This is the medical definition of diarrhea.  Tr. 68; see also P. Ex. 101 ¶ 9; Tr. 42; P. Ex. 101 at 19 (McGreer criteria indicting diarrhea is “3 or more liquid or watery stools above what is normal for the resident within a 24-hour period.”).

6. At the time of the survey, Petitioner had an ICP in place related to COVID-19.  Among other requirements, the ICP provides that residents with symptoms of COVID-19 or who have been exposed to COVID-19 should be placed on transmission-based precautions until the resident meets symptom-based criteria to discontinue the transmission-based precautions.

Petitioner’s COVID-19 ICP included two documents that have, as is relevant to this case, identical provisions.  One is entitled “COVID-19 Guidelines and Procedures for all Facilities,” which Petitioner adopted on March 31, 2020, and revised on August 13, 2020.  CMS Ex. 16 at 5-8.  The second is entitled “COVID-19 Facility Guidelines,” which was adopted on March 31, 2020, and revised on October 15, 2020.   CMS Ex. 16 at 9-12.  The purpose of the ICP is to “identify, screen, optimize supplies and mitigate the spread of the Coronavirus within the facility.”  CMS Ex. 16 at 5, 9.  Relevant provisions include:

• “Create a COVID wing or unit at the facility and seek staff who will be dedicated to this unit.”  CMS Ex. 16 at 5, 9.
• “The facility will also follow the CDC and facility established policies and procedures on isolation precautions.”  CMS Ex. 16 at 6, 10.
• Petitioner “will follow MDH and CDC guidelines for employees diagnosed with COVID[-19] and plan to return to work.”  CMS Ex. 16 at 6, 10.
• Petitioner will continue surveillance on all residents (using the UDA “Existing Resident COVID-19 Screening Tool,”), taking residents temperature, oxygen

Page 14

     saturation, and completing the additional screening questions.  CMS Ex. 16 at 6, 10.

• Residents must be checked in this way at least once per day when there are no known cases of COVID-19 in the facility, twice per day when there are known cases of COVID-19 in the facility, and three times per day for COVID-positive residents and residents who are under investigation.  CMS Ex. 16 at 6, 10.  The ICP also requires:  “When possible, it is the expectation, the screenings are to be done for every resident for every shift, regardless of COVID status.”  CMS Ex. 16 at 6, 11.
• “If you suspect a resident has COVID-19, immediately place them in droplet precautions, place a mask on them, close their door, contact MDH, and your assigned regional clinician and local hospital.  For CDC notification, establish an account with [National Healthcare Safety Network].  In addition, contact the resident representative, MD, guardian (if applicable) and any other provider (dialysis, transportation companies, hospice) and notify them of the resident’s status.  Follow the instructions given by MDH for further instruction and/or transport. . . .  Remember to update the MDH infection control line listing and the resident care plan.”  CMS Ex. 16 at 7, 11.
• “Quarantined residents must have an PPE [personal protective equipment] station at the door with appropriate signage and stay in the assigned room for 14 days.  Residents will have a COVID test performed 2-3 days prior to the end of their quarantine and will be clinically assessed prior to the quarantine being discontinued.  All services for quarantined residents must occur in the room.”  CMS Ex. 16 at 7, 11-12.
• “Resident testing and notification:  Resident guardians/responsible parties must be notified if their family member is being tested.  When test result notification is received, the resident and/or responsible party must be made aware of the results.  If the results are positive, notification to the families by the 5:00pm the next day.  Notification should include:  any resident with a positive result, or 3 or more residents or staff with signs/symptoms occurring within 72 hours of each other.  Subsequent notifications will occur each time as stated.  In the notification, it should include any changes the facility took to mitigate the spread[,] i.e., establishment of COVID wing/unit, isolations precautions etc.  Any resident change in notification will follow the existing change in resident condition facility policy.  The facility notifications will occur as often as necessary but no less than weekly.”  CMS Ex. 16 at 7-8, 12.

Petitioner’s ICP for COVID-19 testing, which was adopted on August 28, 2020, and updated on October 14, 2020, states that:

Page 15

• “Residents with signs and symptoms must be tested.”  CMS Ex. 16 at 13.
• If there is an “Outbreak,” which is defined as “[a]ny new case arises in facility,” then Petitioner is to “[t]est all residents that previously tested negative until no new cases are identified.”  CMS Ex. 16 at 13.
• “If a resident has symptoms consistent with COVID-19 or has been exposed to COVID-19, or if there is a facility outbreak and the resident declines testing, he or she should be placed on or remain on [transmission-based precautions] until he or she meets the symptom-based criteria for discontinuation.”  CMS Ex. 16 at 14.
• Testing should be recorded by the Infection Preventionist and/or designee.  For resident and staff testing, “document date, time, [signs/symptoms], when testing was conducted, when results were obtained and the action the facility took based on the results.”  CMS Ex. 16 at 15.
• “Upon identification of a new COVID-19 case in the facility (i.e., outbreak), document the date the case was identified, the date that all other residents and staff are tested, the dates that staff and residents who tested negative are retested, and the results of all tests.  All residents and staff [who] tested negative are expected to be retested until testing identifies no new cases of COVID-19 infection among staff or residents for a period of at least 14 days since the most recent positive result . . . .”  CMS Ex. 16 at 15.
• “COVID-19 results must be documented in the resident medical record.”  CMS Ex. 16 at 16.

7. Petitioner created a COVID-19 screening tool form for staff to complete each time they assessed residents for COVID symptoms.  The form lists potential symptoms and states that two or more requires the resident to be immediately isolated.

As stated in FFCL 6, Petitioner’s COVID ICP required staff to screen residents at least once a day using the “Existing Resident COVID-19 Screening Tool.”  CMS Ex. 16 at 6, 10.  The expectation was that residents would be screened with the screening tool each shift.  CMS Ex. 16 at 11; Tr. 113.  Latonya E. Davis, RN,4 created the screening tool

Page 16

based on CDC and CMS guidance documents; however, she was unable to identify the specific guidance documents she used.  Tr. 114-15.

The screening tool requires staff to take the resident’s temperature and oxygen saturation rate, and prompts staff to answer “yes” or “no” as to whether the resident has the following symptoms:  cough; shortness of breath or difficulty breathing; fever or chills, sore throat, new loss of taste or smell; muscle pain; chills; nasal congestion or runny nose; diarrhea; fatigue; and headache.  P. Ex. 115 at 13; Tr. at 113.  The screening tool states that if two or more symptoms are present, then “IMMEDIATELY ISOLATE THE RESIDENT.”  P. Ex. 115 at 13; Tr. at 113-14.

8. On September 14, 2020, the facility took a specimen from one of its staff members, NA-D, and sent it for COVID testing.  On September 17, 2020, the testing laboratory notified Petitioner that NA-D was COVID-positive.  NA-D was last at the facility on September 14, 2020.  Petitioner determined that many residents had contact with NA-D, and Petitioner tested those residents three times each from September 17, 2020, through September 28, 2020, or 14 days following the last possible contact with NA-D on September 14, 2020.  Despite exposure to NA-D, Petitioner did not place any of the residents on transmission-based precautions during that 14-day period.

Petitioner’s facility employed a nursing assistant, designated in the survey as NA-D, who also provided beautician services to residents.  Tr. 102-05; CMS Ex. 8 at 2.  Based on specimens collected from NA-D on September 3, 2020, September 8, 2020, and September 10, 2020, Petitioner received laboratory reports on September 5, 2020, September 10, 2020, and September 12, 2020, that NA-D was COVID-negative.  CMS Ex. 17 at 4, 45, 97.

During the week starting on September 14, 2020, NA-D only worked on September 14, 2020, and only provided beautician services, and not nursing assistant services, to residents that day.  Tr. 108-09; CMS Ex. 45 at 19.  On September 14, 2020, NA-D provided beautician services to several residents.  P. Ex. 100 ¶ 28; CMS Ex. 56 ¶ 11.  NA-D was asymptomatic for COVID-19 on September 14, 2020, and wore personal protective equipment (PPE) while performing her beautician duties.  Tr. 108; P. Ex. 100 ¶ 28; CMS Ex. 45 at 20.

On September 14, 2020, the facility collected a specimen from NA-D and sent it to a laboratory for COVID testing.  CMS Ex. 17 at 145; CMS Ex. 45 at 19-20.  On September 17, 2020, at 8:12 a.m., Petitioner received notice from the laboratory that NA-D tested positive for COVID-19.  CMS Ex. 17 at 145.  Shortly after receiving that report, at 8:47 a.m. on September 17, 2020, the facility collected another specimen from NA-D.  CMS Ex. 17 at 174.  On September 20, 2020, the laboratory reported to Petitioner that NA-D

Page 17

was COVID-positive.  CMS Ex. 17 at 174.  NA-D did not return to work at the facility until October 5, 2020.  CMS Ex. 45 at 20.

Nursing notes entered on September 17, 2020, for 17 residents state that the facility notified the families of these residents of a “positive COVID test of a staff member that has worked with the resident.”  The following is the list of residents and corresponding progress notes:  R1 (CMS Ex. 19 at 7, P. Ex. 108 at 4); R4 (CMS Ex. 21 at 8, P. Ex. 109 at 1); R5 (CMS Ex. 22 at 6, P. Ex. 110 at 4); R6 (CMS Ex. 23 at 12); R7 (CMS Ex. 24 at 16); R10 (CMS Ex. 26 at 11); R11 (CMS Ex. 27 at 8); R12 (CMS Ex. 28 at 10-11); R13 (CMS Ex. 29 at 8); R14 (CMS Ex. 30 at 7, P. Ex. 114 at 7); R17 (CMS Ex. 32 at 9); R20 (CMS Ex. 35 at 15); R22 (CMS Ex. 36 at 18); R29 (CMS Ex. 40 at 20); R33 (CMS Ex. 41 at 14); R34 (CMS Ex. 42 at 8); and R38 (CMS Ex. 43 at 4).5

Petitioner’s staff collected specimens for COVID testing from all of these residents, except R20, on September 17 or 18, 2020, September 21 or 22, 2020, and September 28, 2020, and the laboratory reported that all of the tests were negative.  R20 initially refused testing (CMS Ex. 35 at 14) but finally allowed specimens to be collected on September 28, 2020.  The following is a list of the residents and corresponding test results:  R1 (CMS Ex. 17 at 237, 295; CMS Ex. 18 at 27); R4 (CMS Ex. 17 at 227, 318; CMS Ex. 18 at 32); R5 (CMS Ex. 17 at 239, 314, 397); R6 (CMS Ex. 17 at 232, 308; CMS Ex. 18 at 24); R7 (CMS Ex. 17 at 233, 309; CMS Ex. 18 at 19); R10 (CMS Ex. 17 at 236, 320; CMS Ex. 18 at 31); R11 (CMS Ex. 17 at 231, 307, 400); R12 (CMS Ex. 17 at 254 , 324; CMS Ex. 18 at 29); R13 (CMS Ex. 17 at 234, 319; CMS Ex. 18 at 21); R14 (CMS Ex. 17 at 226, 305; CMS Ex. 18 at 28); R17 (CMS Ex. 17 at 226, 339; CMS Ex. 18 at 44); R20 (CMS Ex. 18 at 49); R22 (CMS Ex. 17 at 333; CMS Ex. 18 at 34; CMS Ex. 36 at 18); R29 (CMS Ex. 17 at 246, 331; CMS Ex. 18 at 48); R33 (CMS Ex. 17 at 253, 303; CMS Ex. 18 at 40); R34 (CMS Ex. 17 at 225, 323, 399); and R38 (CMS Ex. 17 at 252, 298; CMS Ex. 18 at 39).  None of the residents tested COVID-positive in September 2020.  Tr. 23, 50, 57.

Page 18

There is no evidence in the record that Petitioner implemented transmission-based precautions for the 17 exposed residents.  CMS Ex. 56 ¶ 11.  Had transmission-based precautions been implemented, that action would be documented in the residents’ medical records.  Tr. 98, 126-27.  There is no reference in the residents’ records that transmission-based precautions were implemented.  Further, one of Petitioner’s witnesses, Nurse Davis, admitted the residents were not placed on transmission-based precautions while awaiting the results of their COVID tests. Tr. 107.

9. Petitioner was not in substantial compliance with infection control regulations at 42 C.F.R. § 483.80(a)(1)-(2) (F-Tag 880) because facility staff failed to fully implement Petitioner’s ICP.  Although a facility staff member tested COVID-positive and the facility identified 17 residents who had been in contact with the staff member, the facility only engaged in COVID testing of the exposed residents and did not implement Petitioner’s ICP that required implementation of transmission-based precautions for the exposed residents.  Failing to do this risked the spread of COVID-19 in the facility.

The Social Security Act (Act) states that an SNF must:

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); see also 42 C.F.R. § 483.80.  The Secretary’s regulations require facilities to establish and maintain an ICP that includes, among other things, a “system for preventing, identifying, reporting, investigating, and controlling infections and communicable diseases for all residents, staff, volunteers, visitors, and other individuals providing services under a contractual arrangement based upon the facility assessment conducted according to § 483.70(e) and following accepted national standards.”  42 C.F.R. § 483.80(a)(1).  The statutory and regulatory mandate to “establish and maintain” an ICP requires SNFs to not only adopt an appropriate ICP, but also to implement the ICP’s prescribed precautions.6  Golden Living Ctr. - Superior, DAB No.

Page 19

2768 at 7 (2017) (citing Heritage House of Marshall Health & Rehab. Ctr., DAB No. 2566 at 12 (2014)).

One of the allegations in the SOD supporting a deficiency under 42 C.F.R. § 483.80 states that several residents “had known exposure to 1 of 1 COVID positive staff (NA-D) . . . .  [T]he facility failed to immediately implement quarantine and use transmission based precautions . . . when residents had known exposure to a COVID positive staff.”  CMS Ex. 1 at 9.

As explained above, 17 residents were exposed to a COVID-positive staff member on or about September 14, 2020.  Other than testing, the nursing notes do not state that any other actions were taken by the facility based on the residents’ exposure to a COVID-positive staff member.  CMS Ex. 56 ¶ 11.  However, Petitioner’s COVID-19 ICP concerning testing states:  “If a resident . . . has been exposed to COVID-19, or if there is a facility outbreak and the resident declines testing, he or she should be placed on or remain on [transmission-based precautions] until he or she meets the symptom-based criteria for discontinuation.”  CMS Ex. 16 at 14.

Petitioner’s witness, Nurse Davis, testified consistently with Petitioner’s policy and agreed that, if a staff member tested positive for COVID-19 and residents were exposed to the staff member, then Petitioner’s staff should place the exposed resident on transmission-based precautions.  Tr. 99.  Nurse Davis also testified that transmission-based precautions include placing the exposed resident in quarantine (i.e., putting the exposed resident in his or her room with a sign saying that you are trying to rule COVID-19 out).  Tr. 95.

Further, Nurse Davis testified that a resident who is exposed to a COVID-positive staff member is someone who is suspected of having COVID-19.  Tr. 102.  If someone is suspected of having COVID-19, Petitioner’s COVID-19 ICP requires staff to implement droplet precautions, which include:  placing a mask on the suspected individual; closing the suspected individual’s door; and contacting MDH and the individual’s clinician.  Tr. 102; CMS Ex. 16 at 7.

CMS’s witness, Nicole Osterloh, RN,7 testified, similar to Nurse Davis, that transmission-based precautions mean the wearing of masks and the use of enhanced gowns and gloves.  Tr. 48.  Nurse Osterloh also testified that quarantine and isolation are sometimes used synonymously, but isolation is very strict (e.g., the resident never leaves

Page 20

his or her room), but quarantine means transmission-based precautions (e.g., the resident’s room door remains shut and the resident wears a mask).  Tr. 69.  The purpose is “to limit the spread [of COVID-19] when we don’t know if someone is truly, in fact, diagnosed with, with that infectious process.”  Tr. 69.

Nurse Davis testified that she was familiar with the situation involving NA-D, who tested positive for COVID-19.  Nurse Davis testified that, on September 14, 2020, NA-D was performing beautician duties and wore PPE while performing those duties.  Tr. 108-09.  Nurse Davis testified that residents touched by NA-D, such as on the hair, would be potentially exposed to COVID-19.  Tr. 106-07.

In her written direct testimony, Nurse Davis took the view that the residents exposed to COVID-19 through NA-D did not need to be isolated on September 17, 2020, because it was “premature” to do so.  P. Ex. 100 ¶¶ 29-36.  Nurse Davis explained that the facility was effectively on “lockdown” since March 2020, which meant residents were not typically going into the community, congregating at meals, and staff were using appropriate PPE.  P. Ex. 100 ¶ 37.  However, Nurse Davis did not explain why the transmission-based precautions, such as signage on the residents’ rooms that the resident was exposed or suspected of COVID-19, and masking would not be appropriate since those were actions Nurse Davis admitted were required by the ICP.  I do not credit Nurse Davis’s opinion that the facility did not need to take any additional actions after the 17 residents were exposed to a COVID-positive staff member to comply with the ICP.

Petitioner argues that 42 C.F.R. § 483.80(a)(2)(iv) specifies that isolation should be the least restrictive possible for the resident under the circumstances and that “there was no need for isolation as proven by the fact that CMS concedes none of the residents in the facility tested positive during the incubation period following their September 14, 2020 haircuts, or after the beautician tested positive on September 17th.”  P. Br. at 10.  This argument is similar to ones presented by Petitioner’s expert witness, Cindy Coral Lindahl, RN,8 when she testified that “CMS wanted [Petitioner] to institute precautions for [the exposed residents.]  [Y]et CMS has not come forward with evidence that those individuals actually contracted COVID-19,” and by Nurse Davis.  P. Ex. 100 ¶ 27; P. Ex. 101 ¶ 12.

Although Petitioner wants to apply an outcome-based test as to whether it was in substantial compliance with 42 C.F.R. § 483.80, this is not the legal standard.  As discussed above, I must determine if Petitioner maintained/implemented its COVID-19

Page 21

ICP.  As Nurse Davis admitted, that ICP required transmission-based precautions when residents were exposed to a COVID-positive individual.  And, as Nurse Davis also admitted, there is no evidence that Petitioner complied with this requirement because the progress notes did not show that such precautions were implemented.  Although Nurse Lindahl appears to disagree with the ICP and would only administer tests to, and conduct surveillance of, residents who were exposed to a COVID-positive staff member, she also “would not say” the ICP’s requirement for transmission-based precautions was not good guidance in the context of COVID-19.  Tr. 127-133.  But engaging in surveillance is not a precaution because staff would only be watching the residents for symptoms.  Tr. 151.  Nurse Lindahl also downplays the threat posed by delay in implementing transmission-based precautions, stating that waiting to implement the precautions “doesn’t carry a risk any higher than asymptomatic people walking around who don’t know who has it . . . .”  Tr. 133.

I reject Petitioner’s arguments.  Petitioner’s legal argument from the regulations conflates isolation and transmission-based precautions.  As Nurse Osterloh testified, isolation and quarantine are often used as synonyms, but isolation is much stricter in restricting an individual’s ability to leave his or her room.  Tr. 69.  Therefore, Petitioner’s citation to the regulation that the parameters for isolation should be flexible, based on the circumstances, is not the relevant provision for this case.  Rather, the same regulation cited by Petitioner has a more relevant provision that states an SNF’s written ICP must include “[s]tandard and transmission-based precautions to be followed to prevent spread of infections.”  42 C.F.R. § 483.80(a)(2)(iii).  In the present case, Petitioner complied with this provision when it established an ICP that required transmission-based precautions to be used when residents were exposed to COVID-19.  CMS Ex. 16 at 14.  However, Petitioner did not implement that provision.

Nurse Osterloh testified that Petitioner’s infection control systems had broken down because Petitioner “did not implement transmission-based precautions appropriately . . . after a known exposure.”  Tr. 66.  Indeed, Petitioner’s staff even allowed one of the exposed residents, R4, to leave the facility for a dental appointment in the afternoon of September 17, 2025, despite the fact R4 could have spread COVID-19 outside the facility.  P. Ex. 109 at 1; CMS Ex. 21 at 8.  Petitioner’s lack of concern mirrors that of Nurse Lindahl when she testified that the exposed residents did not present any additional risk than if an asymptomatic person were walking around.  However, given the very real threat of COVID-19 in the SNF setting, Petitioner needed to closely adhere to its ICP.

Therefore, I conclude that Petitioner failed to implement its COVID-19 ICP when it did not establish transmission-based precautions for 17 residents who were exposed to a COVID-positive facility employee.  In September 2020, COVID was highly transmittable and extremely dangerous to SNF residents.  Therefore, Petitioner was not in substantial compliance with 42 C.F.R. § 483.80(a)(1)-(2).

Page 22

10. From August through October 2020, various residents at the facility manifested symptoms of COVID-19; however, Petitioner’s staff often did not record those symptoms on the facility designed screening tool and did not place those residents on transmission-based precautions.

The SOD identified 24 residents where Petitioner allegedly failed to record COVID-19 symptoms on the facility’s COVID screening tool and failed to place residents with COVID-19 symptoms on transmission-based precautions.

The primary provision of Petitioner’s COVID ICP is as follows:

If a resident has symptoms consistent with COVID-19 . . . he or she should be placed on or remain on [transmission-based precautions] until he or she meets the symptom-based criteria for discontinuation.

CMS Ex. 16 at 14.  Petitioner’s COVID screening tool implemented this provision by only requiring transmission-based precautions when there were two or more COVID-19 symptoms present.  P. Ex. 115 at 13.  Because the state agency did not apply this standard from Petitioner’s COVID ICP, many of the residents identified in the SOD did not require transmission-based precautions.  Below, I discuss each of the identified residents separately.

R1

The SOD stated the following as to R1:

On 9/22/20, staff routinely administered a stool softener but noted R1 had a large loose bowel movement (BM) that day.  There was no indication staff had notified the provider (MD) or otherwise evaluated to determine whether R1’s loose stool following a known exposure to COVID, was related to any need to adjust medication administration, or if the diarrhea was a potential sign of COVID.  R1 continued to have loose stools daily to every other day between 9/30 and 10/27/20.  On 10/27/20, R1 tested positive for COVID.  Review of R1’s COVID-19 Screening Tool identified between 8/31 and 10/27/20, R1 had no symptoms of COVID-19 identified on the COVID-19 Screening Tool.  Therefore [transmission-based precautions] were not implemented prior to the resident testing positive for COVID.

CMS Ex. 1 at 11.

Page 23

At the time of the survey that ended on November 2, 2020, R1 was a nearly 63-year-old man who was admitted to the facility in June 2019 with a principal diagnosis of left side hemiplegia and hemiparesis following a cerebral infarction.  CMS Ex. 19 at 1-3.  R1 also had several other diagnosed conditions including constipation.  P. Ex. 108 at 1; CMS Ex. 12 at 26; CMS Ex. 19 at 3.  Based on the constipation, in 2019, R1 was prescribed one Senna-Docusate Sodium Tablet 8.6-50 MG each day, and R1 was prescribed Bisacodyl Suppository 10 MG on an as needed basis.  P. Ex. 108 at 15-16; CMS Ex. 12 at 82.

On September 22, 2020, R1’s order for the administration of Senna-Docusate Sodium Tablet 8.6-50 MG (i.e., a stool softener) was updated so that R1 would take two tablets each day.  P. Ex. 108 at 4; CMS Ex. 19 at 7.  Petitioner’s staff administered Senna-Docusate Sodium Tablet 8.6-50 MG twice per day for the entire months of October and November 2020.  P. Ex. 108 at 12, 23.  September 22, 2020, is the same day that R1 “[h]ad large loose [bowel movement].”  P. Ex. 108 at 4; CMS Ex. 19 at 7.

Bowel elimination records for R1 show that he had “Loose/Diarrhea” on the following days:

• Three times on September 30, 2020
• Three times on October 2, 2020
• Three times on October 4, 2020
• Once on October 5, 2020
• Once on October 6, 2020
• Once on October 9, 2020
• Once on October 10, 2020
• Twice on October 12, 2020
• Once on October 13, 2020
• Once on October 14, 2020
• Once on October 15, 2020
• Once on October 16, 2020
• Three times on October 17, 2020
• Twice on October 18, 2020
• Once on October 19, 2020
• Once on October 20, 2020
• Once on October 21, 2020
• Once on October 23, 2020
• Twice on October 25, 2020
• Once on October 27, 2020

CMS Ex. 19 at 17-19

Page 24

The CDC consistently listed diarrhea as a COVID-19 symptom.  CMS Ex. 47 at 1; CMS Ex. 48 at 5; CMS Ex. 50 at 2.  However, as stated in FFCL 5, diarrhea is defined as loose or watery stool that occurs three or more times within 24 hours.  According to the records above, staff noted loose stool three times within a 24-hour period on September 30, October 2, October 4, October 17, October 18-19.

The facility completed COVID-19 screening tools for R1 from September 22, 2020 through October 29, 2020, and Petitioner’s staff indicated that R1 did not have any COVID symptoms, expressly indicating that, among other things, R1 did not have diarrhea.  CMS Ex. 19 at 20-124.

In progress notes entered on October 27, 2020, facility staff documented that R1:  tested positive for COVID-19; did not have any symptoms; was cohorted in a room with another COVID-19 positive resident; and was placed on droplet isolation precautions.  P. Ex. 108 at 1; CMS Ex. 19 at 6.  On October 27, 2020, Petitioner reported R1’s COVID-positive test to the state agency and indicated that R1 had no symptoms.  P. Ex. 108 at 28-31.  An October 28, 2020 progress note states that R1 did not have any signs or symptoms of COVID.  CMS Ex. 19 at 5.  Contradictorily, an October 28, 2020 care plan entry states that the goal is for R1’s respiratory symptoms to resolve by the next review date and that isolation protocol will be implemented.  CMS Ex. 12 at 70.

A progress note dated October 30, 2020, stated that R1 had a large loose stool and that R1 has some shortness of breath, headaches, body aches, and coughing.  CMS Ex. 19 at 5.  These are additional symptoms of COVID-19.  CMS Ex. 47 at 1; CMS Ex. 48 at 5; CMS Ex. 50 at 2.

R1 was in isolation due to active COVID-19 infection from the night of October 27, 2020 through the day on November 2, 2020.  P. Ex. 108 at 12, 24.

Petitioner’s witness, Nurse Davis, testified that R1 was on a laxative, Seena Docusate, and no irregular bowel activity was documented for R1.  P. Ex. 100 ¶ 29; P. Ex. 117.  Petitioner’s expert witness, Nurse Lindahl, testified that R1 was on Seena Docusate twice a day based on the constipation diagnosis, and implied that the Seena Docusate caused the loose stools.  P. Ex. 101 ¶ 17.  Nurse Lindahl pointed out that, despite loose stools, R1 continued to test COVID-negative during the period in questions.  P. Ex. 101 ¶ 17.

The record shows that Petitioner’s staff did not correctly complete the COVID-19 screening tool because staff did not indicate on the screening tool, for the dates where there were three incidents of loose stool within 24 hours, that R1 had a symptom of COVID-19.  Even if staff believed that the loose stool was caused by R1’s constipation and/or the treatment for that constitution, staff needed to properly document on the screening tool that R1 had diarrhea.  R1’s medical record makes no mention as to what

Page 25

staff believed about the loose stool incidents.  Therefore, Petitioner’s staff did not fully implement Petitioner’s COVID ICP.

Despite this, Petitioner did not violate the ICP when it did not implement transmission-based precautions for R1.  R1 did not have two or more COVID-19 symptoms.  Both the ICP and the screening tool indicate that more than one symptom was needed to require Petitioner to initiate transmission-based precautions or isolation.

R3

The SOD stated the following as to R3:

R3’s progress notes identified on 9/10/20, R3 had an emesis and complained of an upset stomach.  On 9/15/20, the notes indicated R3 experienced a headache.  The progress notes made no mention these symptoms were reviewed for potential COVID.  R3 was not placed on [transmission-based precautions] or the MD notified at the onset of symptoms to identify or prevent potential spread of COVID.

CMS Ex. 1 at 11.

At the time of the survey that ended on November 2, 2020, R3 was a 68-year-old woman who was admitted to the facility in February 2020 with diagnoses that included bilateral primary osteoarthritis of knee, overactive bladder, gastro-esophageal reflux disease (GERD) without esophagitis, unspecified asthma (uncomplicated), and unspecified urinary incontinence.  CMS Ex. 14 at 5-6, 26; CMS Ex. 20 at 2-3.

The CDC consistently listed vomiting and headache as COVID-19 symptoms.  CMS Ex. 47 at 1; CMS Ex. 48 at 5; CMS Ex. 50 at 2.

On June 4, 2020, the facility created a new entry in R3’s care plan that focused on:  “Resident is at risk for signs and symptoms of COVID-19.”  CMS Ex. 14 at 102.  One of the care plan’s interventions was to “[o]bserve and promptly report [signs and symptoms] of COVID-19: fever, cough, sneezing, sore throat, respiratory issues.”  CMS Ex. 14 at 102.  The care plan failed to list all potential COVID symptoms, including headache and vomiting.  CMS Ex. 14 at 102.

In R3’s progress notes, a September 10, 2020 entry states that R3 “had an extra-large emesis while in bed.  Resident kept saying it was indigestion.”  CMS Ex. 14 at 120; CMS Ex. 20 at 5.  In a progress note entered on September 15, 2020, facility staff documented that R3 “complains of headache” and was given acetaminophen.  CMS Ex. 14 at 120; CMS Ex. 20 at 5.

Page 26

Petitioner’s witnesses did not dispute that the progress notes document that R3 had two symptoms of COVID-19 within five days of each other.  The witnesses instead testified that CMS was merely speculating about symptoms that a variety of facility residents had, including R3, that are typical in the SNF setting, and that CMS provided no evidence that R3 contracted COVID-19.  P. Ex. 100 ¶¶ 26-27; CMS Ex. 101 ¶ 12.

On September 17, 2020, and September 20, 2020 a specimen from R3 was sent for COVID testing, and on September 19, 2020, and September 23, 2020, R3 tested negative for COVID.  CMS Ex. 17 at 222, 292.

While R3 did not contract COVID-19, facility staff identified two COVID-19 symptoms within days of each other.  Under Petitioner’s COVID ICP, the facility was to place R3 under transmission-based precautions.  Petitioner did not do this; therefore, Petitioner did not fully implement the ICP.

R5

The SOD stated the following as to R5:

R5’s progress notes identified on 9/13/20, R5 experienced an upset stomach and diarrhea.  On 9/14/20, R5 was not feeling well, and had an upset stomach.  On 9/17/20, R5 was exposed to a staff member who was positive for COVID.  There was no mention R5 was placed on [transmission-based precautions] after known exposure.  On 9/30/20, R5 experienced new onset dizziness.  On 10/19/20, R5 had increased lethargy, confusion, nausea, and dizziness.  On 10/27/20, R5 tested positive for COVID.  The notes made no mention R5 was placed on [transmission-based precautions] after the onset of symptoms to prevent potential spread of COVID.

CMS Ex. 1 at 12.

At the time of the survey that ended on November 2, 2020, R5 was an 81-year-old woman who was admitted to the facility in May 2019 with diagnoses that included Alzheimer’s disease, edema, dizziness and giddiness, and GERD.  CMS Ex. 22 at 2-3.

The CDC listed fatigue, malaise, nausea, vomiting, and new dizziness as COVID-19 symptoms.  CMS Ex. 47 at 1; CMS Ex. 48 at 5; CMS Ex. 50 at 2.

An August 14, 2020 progress note stated that R5 fell when she bent over to pick something up off the floor.  CMS Ex. 22 at 7.

Page 27

An August 15, 2020 progress note stated that R5 fell in her room and said that she “got dizzy and fell to my knees.”  CMS Ex. 22 at 7.  An August 17, 2020 progress note states that R5 was dizzy when the August 14, 2020 fall happened.  The facility interdisciplinary team reviewed the matter and determined that R5’s blood pressure should be monitored.  CMS Ex. 22 at 7.

A progress report from September 13, 2020, recorded that R5 neither ate breakfast nor lunch, that her stomach hurt, and that she had diarrhea.  P. Ex. 110 at 5.  A September 14, 2020 progress note stated that R5 did not feel well and did not eat dinner, but also stated that R5 did not have diarrhea.  P. Ex. 110 at 4; CMS Ex. 22 at 6.

Petitioner’s staff recorded that R5 did not have any symptoms of COVID-19 on September 13-14, 2020.  CMS Ex. 22 at 181-86.

A bowel elimination report indicated that R5 had loose stool/diarrhea twice on September 13, 2020.  P. Ex. 110 at 6.

A progress note stated that, on September 17, 2020, R5 was tested for COVID-19 based on exposure to a COVID-positive staff member.  CMS Ex. 22 at 5-6.  On September 20, 2020, the test results indicated that R5 was COVID-negative.  P. Ex. 110 at 4; CMS Ex. 22 at 5.

A progress note from September 30, 2020, stated that a fall focus meeting was held based on R5’s fall on August 14, 2020.  Facility staff assessed R5 as high risk for falls.  The fall was described as “bending over fell-stated she was dizzying-Blood pressure is being monitored.”  P. Ex. 110 at 3; CMS Ex. 22 at 5.

A progress note from October 19, 2020, “noted increased confusion, lethargic before dinner, c/o nausea, dizziness.”  P. Ex. 110 at 2; CMS Ex. 22 at 4.  Petitioner’s staff indicated that R5 did not have any symptoms of COVID-19 on October 19, 2020.  CMS Ex. 22 at 79-81.

A progress note from October 27, 2020, indicated that R5 tested positive for COVID-19, did not have symptoms, and was placed on droplet precautions and cohorted in a room with another COVID-positive resident.  P. Ex. 110 at 1; CMS Ex. 22 at 4.

In an October 27, 2020 report concerning R5’s positive COVID test, Petitioner indicated that R5 had COVID symptoms on October 23, 2020; however, Petitioner did not specify what those symptoms were.  P. Ex. 110 at 12-16.

I find that Petitioner did not fully implement its COVID ICP because R5 had COVID symptoms of lethargy and nausea on October 19, 2020; however, Petitioner did not

Page 28

institute transmission-based precautions for R5.  Petitioner’s expert witness, Nurse Lindahl, testified that at the time R5 was experiencing confusion, lethargy, and nausea, R5 also had dark and cloudy urine, likely evidencing a urinary tract infection, and Petitioner sought an order for urinalysis.  P. Ex. 101 ¶ 20.  This may be, but Petitioner was obligated under the COVID ICP to take action when there were at least two COVID symptoms.  Implementing transmission-based precautions while investigating another cause for the symptoms would have been the proper course under the ICP.

Despite my finding, it is not based on Petitioner’s failure to act based on R5’s two loose stools on September 13, 2020, because two loose stools did not constitute diarrhea.  I also do not consider R5’s dizziness as a symptom of COVID because it was not new dizziness.  As Nurse Lindahl testified:

The SOD alleges that R5 had a “new onset of dizziness” on September 30, 2020.  CMS Ex. 1 at 12.  This finding is out of context and mischaracterizes the documentation.  CMS based this citation on a September 30, 2020 Interdisciplinary Team note which was a follow up regarding R5’s falls in August of 2020.  CMS Ex. 22 at 3.  The progress note identifies one fall on August 14, 2020 and explains that R5 was “bending over fell stated she was dizzy-Blood pressure being monitored.” CMS Ex. 22 at 5.  CMS apparently missed that R5 has a diagnosis ICD 10 code R42, which means R5’s baseline condition is dizziness and giddiness.  R5 experienced this condition prior to R5’s admission on May 31, 2019.  CMS Ex. 22 at 3.

P. Ex. 101 ¶ 19.

R6

The SOD stated the following as to R6:

R6’s progress notes identified on 9/17/20, R6 was exposed to a staff member who tested positive for COVID.  There was no indication R6 was placed on quarantine or [transmission-based precautions] after known exposure.  On 10/19/20, and 10/27/20, R6 had loose stools.  On 10/27/20, R6 experienced increased incontinence, headache and low back pain.  On 10/27/20, R6 tested positive for COVID.  The notes made no mention R6 was placed on quarantine or [transmission-based precautions] at the onset of symptoms 10/19/20.

Page 29

CMS Ex. 1 at 12.

At the time of the survey that ended on November 2, 2020, R6 was a 75-year-old man who was admitted to the facility in July 2020 with diagnoses that included cellulitis of abdominal wall, type 2 diabetes, chronic fatigue, and repeated falls.  CMS Ex. 23 at 3-4.

The CDC listed nausea, vomiting, diarrhea, fatigue, muscle and body aches, and headache as COVID-19 symptoms.  CMS Ex. 47 at 1; CMS Ex. 48 at 5; CMS Ex. 50 at 2.

Starting on July 15, 2020, R6 was prescribed Imodium of “1 tablet by mouth every 8 hours as needed for Loose Stools.”  P. Ex. 111 at 16.  Bowel elimination records show loose stools on October 19, 2020 and October 27, 2020.  P. Ex. 111 at 9; CMS Ex. 23 at 20-21.

An October 26, 2020 progress note states that at 1:16 p.m., R6 attempted a self-transfer and fell.  The note stated that R6 “has had an increase in incontinent episodes and has c/o headache and low back pain.”  CMS Ex. 23 at 6.  Another October 26 progress note stated that R6 had increased confusion.  CMS Ex. 23 at 6.

An October 27, 2020 progress note stated that R6 was “experiencing headache, weakness, overall unwell,” and a rapid test showed R6 was COVID positive.  P. Ex. 111 at 1; CMS Ex. 23 at 5.  Another progress note on October 27, 2020, stated that R6 was cohorted with another COVID-positive resident and placed in droplet isolation precautions.  P. Ex. 111 at 1.

On COVID-19 screening tools for October 27, 2020, Petitioner’s staff noted no COVID symptoms on that date.  CMS Ex. 23 at 44-46.

An October 27, 2020 COVID report concerning R6’s positive COVID test stated that R6 had COVID symptoms on October 26, 2020; however, Petitioner did not specify what those symptoms were.  P. Ex. 111 at 18-21.  On COVID-19 screening tools for October 26-27, 2020, Petitioner’s staff noted no COVID symptoms on those dates.  CMS Ex. 23 at 44-49, 205-215.

Nurse Lindhal testified that Petitioner acted properly in relation to R6:

CMS’s evidence for R6 is similarly lacking.  From August 2, 2020 through October 25, 2020 none of the over 90 progress notes describe any sign or symptom of COVID-19 despite R6 being exposed to a staff who tested positive on September 17, 2020.  The first noted entry of a change is on October 26, 2020, 40 days following the exposure to the staff who tested

Page 30

positive, which is far beyond the CDC incubation period.  Bowel records from September 29, 2020 through October 28, 2020 (CMS Ex. 23 at 19-21), note R5 had two loose stools eight days apart on October 19, 2020 and October 27, 2020, and R5 was on bowel medication for constipation.

P. Ex. 101 ¶ 21

I find that Petitioner failed to fully implement its COVID ICP when, on October 26, 2020, R6 manifested at least two COVID symptoms (headache and body aches) and Petitioner did not establish transmission-based precautions until October 27, 2020, following a positive COVID test.  Further, Petitioner’s staff failed to document COVID symptoms on screening tools for October 26 -27, 2020, as required by the ICP.

R7

The SOD stated the following as to R7:

R7’s progress notes identified on 8/1/20, 8/2/20, 8/3/20, 8/7/20, 8/8/20, 8/11/20, 8/12/20, 8/13/20, 8/15/20, 8/17/20, 8/19/20, 8/20/20, 8/21/20, and 8/13/20, R7 experienced symptoms of chronic headache, had symptoms of indigestion, congestion, and complained of pain “all over”.  R7 continued to have frequent chronic headaches and on 10/27/20, R7 tested positive for COVID.  The notes made no mention R7 was placed on quarantine or [transmission-based precautions] at the onset of symptoms to prevent potential spread of COVID.  R7 also had an exposure to a COVID positive staff on 9/17/20 without any indication of precautions having been implemented.

CMS Ex. 1 at 12-13.

At the time of the survey that ended on November 2, 2020, R7 was a 59-year-old woman who was admitted to the facility in October 2019 with diagnoses that included type 2 diabetes with foot ulcer, chronic kidney disease (stage 3), chronic diastolic (congestive) heart failure, chronic obstructive pulmonary disease, GERD without esophagitis, and morbid obesity.  CMS Ex. 24 at 2-3.

The CDC listed nausea, vomiting, diarrhea, fatigue, muscle and body aches, congestion or runny nose, and headache as COVID-19 symptoms.  CMS Ex. 47 at 1; CMS Ex. 48 at 5; CMS Ex. 50 at 2.

Page 31

In 2019, R7 was prescribed acetaminophen for headaches and pain, and calcium carbonate antacid tablets for indigestion.  P. Ex. 112 at 34; CMS Ex. 24 at 47.

Progress notes from August 1-3, 7-9, 11-13, 15-17, 19-23, and 28, 2020, stated that R7 was treated for headaches and or other pain, including back pain, nasal congestion, and indigestion.  P. Ex. 112 at 1-15; CMS Ex. 24 at 19-27.

COVID-19 screening tools completed for R7 from September 1, 2020 through October 29, 2020, show that staff did not indicate R7 had symptoms of COVID-19, except on September 20 and 22, 2020, where staff marked that R7 had a headache but that isolation was not needed.  CMS Ex. 24 at 50-210.

On October 28, 2020, Petitioner learned that R7 tested positive for COVID-19.  R7 was placed on droplet precautions.   P. Ex. 112 at 17-18; CMS Ex. 24 at 5.  In an October 28, 2020 report on R7’s positive COVID test, Petitioner indicated that R7 had COVID symptoms beginning on October 28, 2020.  P. Ex. 112 at 42-45.  An October 28, 2020 progress note documents that R7 indicated she had pain in her neck on a daily basis.  P. Ex. 112 at 18.

Petitioner’s witnesses disagree with CMS that R7 should have been placed on transmission-based precautions due to symptoms in August 2020.  Nurse Davis testified:  “CMS asserts that R7’s symptoms began in August, yet indigestion and headaches were baseline conditions.  P. Ex. 112 at 34, (pain medication for headaches dating back to ‘10/21/19.’) None of the entries on the Bowel Report demonstrate any concern for R7.”  P. Ex. 100 ¶ 32.  Nurse Lindhal explained:  “R7 had a diagnosis of GERD and was receiving two calcium carbonate tablets up to three times a day as needed.  CMS Ex. 24 at 10.  That order was effective from R7’s day of admission October 21, 2019.  P. Ex. 112 at 34. CMS Ex. 24 at 4-18 reveals forty-five complaints of headache, backache, or knee pain, which to me demonstrates a consistent pattern of taking Tylenol or tramadol for pain that was unrelated to COVID-19.”  P. Ex. 101 ¶¶ 24-25.

I do not find that Petitioner failed to implement its COVID ICP regarding R7.  I agree that the August notations document R7’s known and consistent medical problems.

R8

The SOD stated the following as to R8:

R8’s progress notes identified on 10/6/20, R8 had loose stools which was not common for the resident.  On 10/20/20, R8 was irritable and lethargic.  On 10/22/20, R8 complained of a headache and neck pain.  On 10/27/20, R8 tested positive for COVID.  There was no documentation to indicate R8 was

Page 32

placed quarantine or [transmission-based precautions] at the onset of symptoms.

CMS Ex. 1 at 13.

At the time of the survey that ended on November 2, 2020, R8 was a 73-year-old woman who was admitted to the facility in June 2017 with diagnoses that included schizoaffective disorder, type 2 diabetes mellitus, vascular dementia without behavioral disturbance, and malignant neoplasm of endometrium and of the breast.  CMS Ex. 25 at 3-4.

The CDC listed nausea, vomiting, diarrhea, fatigue, muscle and body aches, congestion or runny nose, and headache as COVID-19 symptoms.  CMS Ex. 47 at 1; CMS Ex. 48 at 5; CMS Ex. 50 at 2.

An October 19, 2020 progress note stated that:  “She is also not getting up for breakfast, due to her staying up to late and sleeps half the day away.  She gets easily angered with staff, she will get delusional thinking she has to go to her graduation, this occurs about weekly.”  CMS Ex. 25 at 7-8.  An October 20, 2020 entry documents that R8 was “[v]ery sleepy today she got frustrated and short tempered with staff trying to wake up for meal.”  CMS Ex. 25 at 7.

In a progress note entered on October 22, 2020, facility staff documented that R8 “does have frequent complaints of pain in her[]back neck and head.  She takes Tylenol, Ibuprofen orally and uses Voltaren gel topically.”  CMS Ex. 25 at 6.

The record shows that R8 took Tylenol, Ibuprofen, and Voltaren often for fibromyalgia and back pain.  CMS Ex. 25 at 7-10, 12-15.

Progress notes for October 27, 2020, document that R8 tested positive for COVID-19.  CMS Ex. 25 at 5.  Progress notes for October 29, 2020 state that R8 had a sore throat and did not feel well.  CMS Ex. 25 at 5.  Petitioner’s staff prepared a COVID-19 screening tool on October 29, 2020, and indicated that she had the COVID-19 symptom of a sore throat.  CMS Ex. 25 at 22.  COVID screening tools completed between September 1, 2020 and October 28, 2020 indicated no symptoms of COVID-19.  CMS Ex. 25 at 23-186.

Nurse Lindhal testified that Petitioner did not act improperly concerning R8:

In reviewing CMS’s analysis of R8, (CMS Ex. 25), CMS failed to consider root causes and instead rushed to conclude that R8 had symptoms of COVID-19 much earlier than R8’s positive test result on October 27, 2020.  The November 2,

Page 33

2020 SOD states that a progress note on October 6, 2020 reported that R8 had loose stools, which CMS states were “uncommon” for R8.  CMS Ex. 1 at 13.  Yet CMS Ex. 25 at 19 shows R8 only experienced one loose stool elimination 13:13.  CMS Ex. 25 at 19.  The SOD further asserts that R8 was “irritable and lethargic” on October 20, 2020, yet the progress note from that day is less concerning and reflects a quite common complaint, stating “very sleepy today she got frustrated and short tempered with staff trying to wake her up for a meal.”  CMS Ex. 25 at 7. 

CMS also relies on an October 22, 2020 complaint of headache and neck pain.  CMS Ex. 1 at 13.  It appears to me that CMS is referring to an MDS quarterly note on that day which simply reiterated R8’s chronic condition.  I find no reliable indication that was an onset of a new symptom.

CMS Ex. 101 ¶¶ 26-27.

I agree with Ms. Lindhal that Petitioner did not fail to act on potential COVID symptoms given the context of R8’s history and the specific progress notes that the SOD relied on to show deficient conduct.

R10

The SOD stated the following as to R10:

R10’s progress notes identified on 10/4/20, 10/12/20, 10/27/20, and 10/28/20, R10 had loose stools.  The notes made no mention whether R10 was placed on quarantine or [transmission-based precautions] at the onset of symptoms to prevent potential spread of COVID.

CMS Ex. 1 at 13.

At the time of the survey that ended on November 2, 2020, R10 was an 84-year-old woman who was admitted to the facility in November 2019 with diagnoses that included hypo-osmolality and hyponatremia, dehydration, dementia, constipation, Alzheimer’s disease, and chronic obstructive pulmonary disease with acute exacerbation.  CMS Ex. 26 at 3-4.

The CDC consistently listed diarrhea as a COVID-19 symptom.  CMS Ex. 47 at 1; CMS Ex. 48 at 5; CMS Ex. 50 at 2.

Page 34

On September 27, 2020, Milk of Magnesia was provided to R10 twice because there had been no bowel movements for two days.  CMS Ex. 26 at 8-9.

The bowel elimination record for R10 shows loose stools on the following dates:

• October 4, 2020 at 9:59 p.m.
• October 12, 2020 at 9:48 p.m.
• October 27, 2020 at 1:59 p.m.
• October 28, 2020 at 8:23 p.m.

CMS Ex. 26 at 22-24

The evidence of record does not support that R10 showed a symptom of COVID.  R10 did not have three or more loose stools within a 24-hour period.  Therefore, Petitioner did not fail to implement the COVID ICP when it did not place R10 on transmission-based precautions.

R11

The SOD stated the following as to R11:

R11’s progress notes identified R11 had loose stools on 10/2/20, 10/8/20, 10/9/20, 10/10/20, 10/11/20, 10/12/20, 10/13/20, 10/14/20, 10/15/20, 10/16/20, 10/17/20, 10/19/20, 10/20/20, 10/21/20, 10/23/20, 10/24/20, and 10/25/20.  On 10/5/20, R11 had diminished lung sounds with crackles in both upper and lower lobes, and mucous-like cough.  On 10/27/20, R11 tested positive for COVID.  R11’s COVID screens made no mention R11 had symptoms of diarrhea and respiratory symptoms prior to 10/29/20.  The notes made no mention R11 was placed on [transmission-based precautions] at the onset of symptoms or whether the MD had been informed, to weigh in on potential symptoms to prevent potential spread of COVID.

CMS Ex. 1 at 13.

At the time of the survey that ended on November 2, 2020, R10 was an 85-year-old man who was admitted to the facility in June 2020 with diagnoses that included Parkinson’s Disease, type 2 diabetes, constipation, GERD without esophagitis, and diverticulosis of intestine.  CMS Ex. 27 at 3-4.

Page 35

The CDC listed nausea, vomiting, diarrhea, fatigue, muscle and body aches, cough, congestion or runny nose, and headache as COVID-19 symptoms.  CMS Ex. 47 at 1; CMS Ex. 48 at 5; CMS Ex. 50 at 2.

The bowel elimination record for R11 shows loose stools on the following dates:

• October 2, 2020 at 1:59 p.m.
• October 8, 2020 at 11:28 a.m.
• October 9, 2020 at 9:59 p.m.
• October 10, 2020 at 11:27 a.m.
• October 10, 2020 at 4:45 p.m.
• October 11, 2020 at 4:04 a.m.
• October 12, 2020 at 5:23 a.m.
• October 12, 2020 at 9:59 p.m.
• October 13, 2020 at 1:59 p.m.
• October 14, 2020 at 5:43 a.m.
• October 14, 2020 at 1:59 p.m.
• October 15, 2020 at 9:20 p.m.
• October 16, 2020 at 9:31 p.m.
• October 17, 2020 at 3:20 p.m.
• October 19, 2020 at 1:59 p.m.
• October 20, 2020 at 5:59 a.m.
• October 20, 2020 at 1:59 p.m.
• October 21, 2020 at 9:38 p.m.
• October 23, 2020 at 1:59 p.m.
• October 23, 2020 at 9:59 p.m.
• October 24, 2020 at 1:59 p.m.
• October 25, 2020 at 1:59 p.m. 

CMS Ex. 27 at 17-19.

In October 4 and 5, 2020 COVID-19 screening tool documents, staff indicated that R11 has COVID symptom of nasal congestion or runny nose, but staff also indicated that R11 did not require isolation at that time.  CMS Ex. 27 at 115-16, 118-120.  On October 4-5, 2020, R11’s oxygen saturation rate was, on three occasions, only 92%, 93%, and 94%.  CMS Ex. 27 at 30.  On October 5, 2020, a facility LPN reported:  “Lower lobe bilaterally lung sound diminished.  Left and right upper lobes crackles are present.  Resident [s]tates ‘mucousy cough.’”  CMS Ex. 27 at 21.  An X-ray of the lungs produced a finding that the lungs are clear with no evidence of acute pulmonary disease.  CMS Ex. 27 at 6, 22.

Page 36

An October 7, 2020 progress note indicated a new order to provide Augmentin, an antibiotic, for R11 for 10 days.  CMS Ex. 27 at 6.

On October 14, 2020, a facility nurse reported that R11 started taking Augmentin 875mg and has been having diarrhea three time per day.  The nurse requested to discontinue the Augmentin.  The nurse also noted that R11 did not have a cough and that the X-ray showed no evidence of pulmonary disease.  CMS Ex. 27 at 20.

An October 14, 2020 progress note states that R11 was given MiraLax powder and Benefiber Powder for constipation and diarrhea.  Further, a progress note records that a new order discontinued the Augmentin.  CMS Ex. 27 at 5.

None of the COVID-19 screening tool documents for September and October 2020, indicated that R11 had diarrhea.  See CMS Ex. 27 at 49-211.

An October 27, 2020 progress note states that R11 tested positive for COVID-19.  CMS Ex. 27 at 5.  An October 28, 2020 COVID-19 screening tool document indicates that R11 had a cough and was in isolation.  CMS Ex. 27 at 50.  An October 29, 2020 COVID-19 screening tool document indicates that R11 had a cough and nasal congestion or a runny nose, and that R11 was in isolation.  CMS Ex. 27 at 49.

Nurse Lindhal testified that Petitioner did not fail to implement its COVID ICP:

CMS also fails to consider the obvious reason for that R11 developed loose stools after one staff member tested positive on September 17, 2020.  (CMS Ex. 27).  On October 5, 2020 Crossroads sent the attending physician a fax stating that R11 self-reported a “mucousy cough.”  The nurse listened for lung sounds and reported “crackles.”  The physician provider group ordered a CXR (chest X-Ray) and CBC with diff (a complete blood count).  Anticipating an infection may be confirmed by an increase in the white blood cells, the ordered Augmentin, an antibiotic. 

A known side effect of Augmentin is diarrhea, and prior to October 5, 2020 R11’s Bowel Records at CMS Ex. 27 at 17 document only one loose stool prior to the administration of Augmentin.  After R11 began Augmentin the frequency of loose stools increased.

On October 14, 2020 Crossroads’ nursing team recontacted the attending physician to report a negative CXR and requested that due to the increase in loose stool, Augmentin be

Page 37

discontinued.  The physician agreed.  This tells me that the root cause of the loose stools was the Augmentin and not the exposure to a staff who tested positive.  The SOD confirms that R8 did not contract COVID-19.

P. Ex. 101 ¶¶ 28-30.

In retrospect, Nurse Lindhal’s analysis is likely correct as to the cause of R11’s diarrhea.  However, unlike R8, during October 4-5, 2020, Petitioner could not immediately know whether R11’s symptoms of congestion and cough meant that R11 was infected with COVID.  Having noted those two symptoms, Petitioner should have initiated transmission-based precautions.  Further, diarrhea commenced a few days later.  The bowel records show four 24-hour periods on October 10-11, October 13-14, October 19-20, and October 23-24, where R11 had three loose.  Therefore, another COVID symptom was added to this situation.  Petitioner was not free to investigate R11’s symptoms without also initiating transmission-based precautions.

R12

The SOD stated the following as to R12:

R12’s progress notes identified between 8/5/20 and 9/4/20, R12 had frequent loose stools.  R12 was tested on 9/18/20 with negative results.  R12’s COVID Screening Tool documents made no mention R12 had diarrhea.  The notes made no mention whether R12 was placed on [transmission-based precautions] when the diarrhea began or the MD notified.

CMS Ex. 1 at 14.

At the time of the survey that ended on November 2, 2020, R12 was a 75-year-old woman who was admitted to the facility in July 2017 with diagnoses that included Alzheimer’s disease, dementia, and constipation.  CMS Ex. 28 at 1-2.

The CDC consistently listed diarrhea as a COVID-19 symptom.  CMS Ex. 47 at 1; CMS Ex. 48 at 5; CMS Ex. 50 at 2.

The bowel elimination record for R12 shows loose stools on the following dates:

• October 6, 2020 at 11:34 a.m.
• October 8, 2020 at 11:33 a.m.
• October 12, 2020 at 1:59 p.m.

Page 38

• October 14, 2020 at 1:59 p.m.
• October 15, 2020 at 3:15 p.m.
• October 16, 2020 at 10:59 a.m.
• October 17, 2020 at 1:55 p.m.
• October 28, 2020 at 1:59 p.m.
• October 30, 2020 at 1:55 p.m. 

CMS Ex. 28 at 25-27.

The progress notes show that R12 had significant difficulties with constipation.  R12 received various medications and suppositories, such as Lactulose, Senexon-S, and Dulcolax.  CMS Ex. 28 at 3-4, 6, 22-24.

From October 12 through 16, 2020, the most active period for R12’s loose stools, R12 was administered Lactulose for constipation on those dates.  CMS Ex. 28 at 6-7.

Petitioner did not fail to implement its COVID ICP because R12 did not have three loose stools in any 24-hour period.  Therefore, R12 did not have diarrhea or any other symptom of COVID.

R13

The SOD stated the following as to R13:

R13’s progress notes identified on 10/27/10, R13’s roommate tested positive for COVID.  The roommate was moved to another room.  On 10/30/20, R13 had an emesis, and had exhibited increased confusion.  R13 was tested for COVID with negative results.  The notes made no mention R13 was placed on [transmission-based precautions] after known exposure or at the onset of symptoms consistent with COVID.

CMS Ex. 1 at 14.

At the time of the survey that ended on November 2, 2020, R13 was an 88-year-old woman who was admitted to the facility in June 2019 with diagnoses that included Alzheimer’s disease, GERD without esophagitis, and constipation.  CMS Ex. 29 at 1-2.

The CDC consistently listed diarrhea as a COVID-19 symptom.  CMS Ex. 47 at 1; CMS Ex. 48 at 5; CMS Ex. 50 at 2.

Page 39

An October 27, 2020, progress note stated that R13’s roommate tested positive for COVID-19 and the roommate was moved to a different room.  P. Ex. 113 at 2; CMS Ex. 29 at 3.

Progress notes on October 30, 2020, state that R13 had an emesis that morning, a rapid COVID test was administered but R13 was negative, R13 stated to staff that “she feels great,” and staff noted there had been no mood changes in R13.  P. Ex. 113 at 1-2; CMS Ex. 28 at 3.  Progress notes on November 3, 2020, state that R13 tested positive for COVID-19 and indicates that R13 was in isolation.  P. Ex. 113 at 1.  A COVID reporting document dated November 3, 2020, indicated that R13 was placed on transmission-based precautions on October 27, 2020 but oddly states that it was unknown if R13 was in contact with another laboratory confirmed COVID-19 patient.  P. Ex. 113 at 7.

For this incident, the relevant COVID ICP provision states:  “If a resident . . . has been exposed to COVID-19 . . . he or she should be placed on or remain on [transmission-based precautions] until he or she meets the symptom-based criteria for discontinuation.”  CMS Ex. 16 at 14.

The record appears to show that R13 was placed on transmission-based precautions after being exposed to her COVID-positive roommate.  An October 27 progress note establishes that the COVID-positive roommate was moved out of R13’s room on October 27, 2020.  Nurse Davis cites to that note when she testified that “R13 began transmission-based precautions on October 27.”  P. Ex. 100 ¶ 34.  Finally, a November 3, 2020 COVID reporting document indicates transmission-based precautions were implemented on October 27.  P. Ex. 113 at 7.  I find that this is sufficient evidence that Petitioner timely initiated transmission-based precautions on R13 in compliance with the ICP.

R14

The SOD stated the following as to R14:

R14’s progress notes identified 9/17/20, R14 was exposed to a staff member who tested positive for COVID.  On 9/18/20, R14 tested negative for COVID.  Between 10/1 and 10/8/20, R14 experienced dizziness and headache.  On 10/28/20, R14 tested positive for COVID.  The notes made no mention R14 was ever placed on quarantine with [transmission-based precautions] due to exposure, or onset of symptoms consistent with COVID.

CMS Ex. 1 at 14.

Page 40

At the time of the survey that ended on November 2, 2020, R14 was a 77-year-old woman who was admitted to the facility in April 2020 with diagnoses that included chronic kidney disease, type 2 diabetes, malignant neoplasm, essential hypertension, and blindness in both eyes at category 4.  CMS Ex. 30 at 1-2.

The CDC listed nausea, vomiting, diarrhea, fatigue, muscle and body aches, cough, congestion or runny nose, new dizziness, and headache as COVID-19 symptoms.  CMS Ex. 47 at 1; CMS Ex. 48 at 5; CMS Ex. 50 at 2.

An October 1, 2020 progress note and an October 8, 2020 progress note each state that R14 complained of a headache and that acetaminophen was administered.  P. Ex. 114 at 4-6; CMS Ex. 30 at 5-6.  An October 5, 2020 progress note states that R14 complained of dizziness.  P. Ex. 114 at 5; CMS Ex. 30 at 5.

Nurse Lindhal testified that Petitioner acted appropriately:

Regarding R14, between August 3, 2020 and November 1, 2020[,] R14 was administered acetaminophen when R14 complained of headache, shoulder, and neck pain twenty-nine times.  CMS Ex. 30 at 3-10.  On October 5, 2020 R14 reported being dizzy upon entering the elevator.  R14’s blood pressure was noted to be 113/55, and pulse at 54.  R14 was prescribed Norvasc for diagnosis of high blood pressure.  In my opinion these are sufficiently low readings to make a person experience dizziness.  In addition, a second hypertensive medication, Metoprolol, was prescribed for R14.

P. Ex. 101 ¶¶ 33-34.

Nurse Lindhal overstates the number of headaches recorded in the progress notes she cites.  Apart from the headaches identified on October 1 and 8, the progress notes show only three additional entries for headaches in August 2020.  CMS Ex. 30 at 8-9.  Therefore, Petitioner ought to have considered October 5 and 8 headaches as potential COVID symptoms.  Further, while the dizziness R14 experienced on October 5 may have been related to her hypertension, Petitioner needed to consider this a potential COVID symptom as well.  Given the proximity of the headaches and the dizziness, Petitioner failed to fully implement the COVID ICP because it did not institute transmission-based precautions.

R16

The SOD stated the following as to R16:

Page 41

R16’s progress notes identified between 10/4/20, and 10/29/20, R16 had intermittent loose stools.  R16’s COVID Screening tool made no mention R16 was experiencing loose stools.  The notes made no mention R16 was placed on [transmission-based precautions] at the onset of these symptoms consistent with potential COVID or the MD notified.

CMS Ex. 1 at 14.

At the time of the survey that ended on November 2, 2020, R16 was an 86-year-old man who was admitted to the facility on September 30, 2020, with diagnoses that included type 2 diabetes, dementia, and history of trans ischemic attack (TIA).  CMS Ex. 31 at 1-2.

The CDC consistently listed diarrhea as a COVID-19 symptom.  CMS Ex. 47 at 1; CMS Ex. 48 at 5; CMS Ex. 50 at 2.

The bowel elimination record for R16 shows loose stools on the following dates:

• October 4, 2020 at 9:59 a.m.
• October 5, 2020 at 11:29 a.m.
• October 6, 2020 at 8:13 p.m.
• October 7, 2020 at 1:52 p.m.
• October 7, 2020 at 9:50 p.m.
• October 8, 2020 at 4:34 a.m.
• October 10, 2020 at 4:45 p.m.
• October 12, 2020 at 1:59 p.m.
• October 13, 2020 at 1:59 p.m.
• October 16, 2020 at 8:54 p.m.
• October 18, 2020 at 11:39 p.m.
• October 21, 2020 at 1:42 p.m.
• October 25, 2020 at 7:57 p.m.
• October 26, 2020 at 11:00 a.m.
• October 26, 2020 at 9:34 p.m.
• October 29, 2020 at 10:16 a.m.
• October 31, 2020 at 10:19 a.m. 

CMS Ex. 31 at 13-15.

Despite R16 having loose stools through much of October, R16 only once met the criteria for diarrhea when he had three loose stools within 24 hours on October 7-8, 2020.

Page 42

Under Petitioner’s COVID ICP and screening tools, Petitioner only needed to use transmission-based precautions after two symptoms were present.  Because there is only evidence of one symptom concerning R16, Petitioner did not fail to implement its COVID ICP.

R17

The SOD stated the following as to R17:

R17’s progress notes identified between 10/21 and 10/27/20, R17 experienced intermittent loose stools.  The COVID Screening Tool made no mention R17 had symptoms of loose stools, the tool also identified precautions were “not needed”.  The notes made no mention whether R17 was placed on quarantine or [transmission-based precautions] after the onset of symptoms consistent with potential COVID.

CMS Ex. 1 at 14.

At the time of the survey that ended on November 2, 2020, R17 was a 91-year-old man who was admitted to the facility in April 2019 with diagnoses that included vascular dementia, cerebral infarction, repeated falls, and several cardiac related problems.  CMS Ex. 32 at 1-2.

The CDC consistently listed diarrhea as a COVID-19 symptom.  CMS Ex. 47 at 1; CMS Ex. 48 at 5; CMS Ex. 50 at 2.

The bowel elimination record for R17 shows loose stools on the following dates:

• October 21, 2020 at 1:42 p.m.
• October 21, 2020 at 8:45 p.m.
• October 22, 2020 at 11:34 a.m.
• October 22, 2020 at 9:24 p.m.
• October 25, 2020 at 2:34 p.m.
• October 26, 2020 at 9:29 p.m. 

P. Ex. 115 at 1; P. Ex. 117 at 13-15; CMS Ex. 32 at 16.

According to a progress note on October 9, 2020, R17 had a “Xlarge incontinent loose bm” with “BM . . . running down both of his legs.”  CMS Ex. 32 at 6.  A progress note on October 12, 2020, states that R17 had “an acute bout of loose stools” but there were “[n]o

Page 43

further loose stools.”  CMS Ex. 32 at 6.  Neither of these loose stools were reported in the bowel report.  CMS Ex. 32 at 15.

R17 received fiber liquid and Senna-Docusate Sodium Tablet for constipation every day in October 2020.  P. Ex. 115 at 3, 6.  R17 was prescribed Milk of Magnesia for constipation but does not appear to have been given it in October 2020.  P. Ex. 115 at 11.

From October 27, 2020, Petitioner’s staff did not indicate on COVID-19 screening tool documents for October 27, 2020, that R17 had COVID symptoms.  P. Ex. 115 at 13-15.  The parties did not provide COVID-19 screening tool documents for October 21-22, 2020.

A progress note dated October 29, 2020, stated that R17 had loose stools within the last 30 days, that R17’s physician and family were notified, and R17 had a negative COVID test result.  CMS Ex. 32 at 3.

Petitioner’s expert witness, Nurse Lindhal, testified that R17’s bowel report should not be considered unusual due to R1’s longstanding reliance on Senna-Docusate Sodium and Milk of Magnesia.  P. Ex. 100 ¶ 35.

As stated above, the bowel record shows that R17 had three loose stools within a 24-hour period from October 21-22, 2020.  Because this met the definition for diarrhea, Petitioner’s staff should have recorded that symptom on the COVID-19 screening tool.  Because Petitioner’s staff did not do that, Petitioner did not fully implement the COVID ICP.  However, despite this, Petitioner was not obligated to initiate transmission-based precautions under the COVID ICP because the records show only a single symptom and not two or more.

R18

The SOD stated the following as to R18:

R18’s progress notes identified R18 was admitted to the dementia unit on 9/24/20.  Between 10/4/20, and 10/26/20, R18 experienced intermittent loose stools.  R18’s Covid Screening Tool made no mention R18 had symptoms of loose stools.  Additionally, the notes made no mention whether R18 was placed on [transmission-based precautions] upon admission or when diarrhea, a potential symptom of COVID, developed.

CMS Ex. 1 at 15.

Page 44

At the time of the survey that ended on November 2, 2020, R18 was a 79-year-old woman who was admitted to the facility on September 24, 2020 with diagnoses that included constipation, ileus (unspecified), cerebral palsy, acute respiratory failure, and unspecified severe protein-calorie malnutrition.  CMS Ex. 33 at 1-2.

The CDC consistently listed diarrhea as a COVID-19 symptom.  CMS Ex. 47 at 1; CMS Ex. 48 at 5; CMS Ex. 50 at 2.

The bowel elimination record for R18 shows loose stools on the following dates:

• October 4, 2020 at 4:37 a.m.
• October 4, 2020 at 8:41 a.m.
• October 5, 2020 at 4:31 a.m.
• October 5, 2020 at 9:59 p.m.
• October 6, 2020 at 10:13 a.m.
• October 7, 2020 at 9:53 p.m.
• October 9, 2020 at 5:35 a.m.
• October 10, 2020 at 5:59 a.m.
• October 10, 2020 at 1:59 p.m.
• October 10, 2020 at 9:51 p.m.
• October 11, 2020 at 4:12 a.m.
• October 12, 2020 at 6:23 p.m.
• October 14, 2020 at 6:08 p.m.
• October 18, 2020 at 7:30 p.m.
• October 21, 2020 at 1:43 a.m.
• October 25, 2020 at 11:21 a.m.
• October 26, 2020 at 10:10 a.m.
• October 26, 2020 at 9:10 p.m.
• October 30, 2020 at 8:04 p.m.
• November 1, 2020 at 5:59 p.m. 

P. Ex. 117 at 17-19; CMS Ex. 33 at 18-20.

R18 was prescribed MiraLax and bisacodyl suppository (needed for ileus and constipation); however, these were not provided to R18 in October 2020.  P. Ex. 116 at 38-39.  R18 was also prescribed Senokot S for ileus, and this was provided to R18 each day in October 2020.  P. Ex. 116 at 34.

A September 25, 2020 progress note states that R18 is incontinent of bowel.  P. Ex. 116 at 17; CMS Ex. 33 at 16.

Page 45

An October 11, 2020 progress note states that R18 was given the laxative Senokot S for ileus diagnosis and there is a note of “loose stool.”  P. Ex. 116 at 8; CMS Ex. 33 at 9.

An October 29, 2020 progress note indicates that R18 had experienced loose stools over the last 30 days, that R18’s physician was notified, and that a COVID test was negative.  P. Ex. 116 at 2; CMS Ex. 33 at 5.

In a November 11, 2020 report that R18 had tested positive for COVID-19, Petitioner indicated that R18 did not have any symptoms.  P. Ex. 116 at 43.

Petitioner’s expert witness, Nurse Lindhal, testified that R18’s medical condition and treatment for that condition can result in loose stools.  She stated:

CMS seemed to miss the fact that R18 had an ileus diagnosis. Although in the presence of a staff person who tested positive on September 17, 2020, R18 did not test positive until November 11, 2020 long after the typical incubation period.  R18 previously tested negative for COVID-19 on October 29 and 30, 2020, after experiencing loose stools that were likely attributed to drinking six cups of hot cocoa.  P. Ex. 116 at 1.  R18 was placed in precautions on November 11, 2020 after testing positive that same day.  P. Ex. 116 at 42, 43. 

Ileus is the inability of the bowel to contract normally and move waste out of the body.  To address this disease, R18 was placed on a probiotic for antibiotic use and gastrointestinal (“GI”) health due to the likelihood of altered GI function.  In my experience that diagnosis and treatment can result in intermittent loose stools.  R18 was also on the laxative Senna since February 21, 2021, which may cause loose stools.  P. Ex. 116 at 34.

P. Ex. 101 ¶¶ 22-23.

The record shows that R18 had three or more loose stools within a 24-hour period on October 4-5, 2020 and October 10-11, 2020.  As a result, R18 had diarrhea twice, which is a symptom of COVID-19.  There is no evidence that Petitioner recorded these symptoms on the COVID-19 screening tool for those dates, as required by the COVID ICP.  However, the ICP did not require transmission-based precautions to be implemented because R18 only exhibited a single symptom.  And there is significant evidence that the loose stools were caused by another medical condition.

Page 46

R19

The SOD stated the following as to R19:

R19’s progress notes identified between 10/4/20 and 10/27/20, R19 experienced intermittent loose stools.  R19’s COVID Screening Tool made no mention R19 was experiencing symptoms of loose stools.  The notes made no mention whether R19 was placed on quarantine or [transmission-based precautions] when the diarrhea developed.

CMS Ex. 1 at 15.

At the time of the survey that ended on November 2, 2020, R19 was a 90-year-old man who was admitted to the facility on July 20, 2020 with diagnoses that included Alzheimer’s disease, dementia, chronic pain, and type 2 diabetes.  CMS Ex. 34 at 1-2.

The CDC consistently listed diarrhea as a COVID-19 symptom.  CMS Ex. 47 at 1; CMS Ex. 48 at 5; CMS Ex. 50 at 2.

The bowel elimination record for R19 shows loose stools on the following dates:

• October 4, 2020 at 11:14 a.m.
• October 9, 2020 at 2:32 a.m.
• October 9, 2020 at 4:33 a.m.
• October 11, 2020 at 4:10 a.m.
• October 11, 2020 at 5:59 a.m.
• October 12, 2020 at 4:04 a.m.
• October 15, 2020 at 4:38 p.m.
• October 27, 2020 at 4:11 a.m. 

P. Ex. 117 at 19-20; CMS Ex. 34 at 27-28.

Progress notes on August 9-10, 2020, indicate milk of magnesia was provided to R19 for constipation.  CMS Ex. 34 at 24.  Progress notes on August 23, 2020, indicate that two Dulcolax suppositories were given.  CMS Ex. 34 at 21.  Progress notes on September 4, 2020, and September 29, 2020, indicate that a Dulcolax suppository was given to R19.  CMS Ex.34 at 11, 19-20.

Page 47

A progress note from October 9, 2020, stated that Imodium was given to R19 because it was “needed for loose stools.”  CMS Ex. 34 at 8.  An October 29, 2020 progress note indicated that R19 had experienced loose stools over the last 30 days, that R19’s family was notified, and that a COVID test was negative.  CMS Ex. 34 at 3.

The record shows that R19 had three loose stools within a 24-hour period on October 11-12, 2020.  As a result, R19 had diarrhea, which is a symptom of COVID-19.  There is no evidence that Petitioner recorded these symptoms on the relevant COVID-19 screening tool, as required by the COVID ICP.  However, the ICP did not require transmission-based precautions to be implemented because R19 only exhibited a single symptom.  And there is evidence that the loose stools were related to constipation and the treatment for constipation.

R20

The SOD stated the following as to R20:

R20’s progress notes identified between 10/26/20 and 10/27/20, R20 had loose stools.  R20’s COVID Screening Tool made no mention R20 experienced loose stools.  The notes made no mention whether R20 was placed on quarantine or [transmission-based precautions] when the diarrhea developed.

CMS Ex. 1 at 15.

At the time of the survey that ended on November 2, 2020, R20 was a 66-year-old man who was admitted to the facility on August 11, 2020 with diagnoses that included vascular dementia and cerebral infarction due to occlusion or stenosis of small artery.  CMS Ex. 35 at 2.

The CDC consistently listed diarrhea as a COVID-19 symptom.  CMS Ex. 47 at 1; CMS Ex. 48 at 5; CMS Ex. 50 at 2.

The bowel elimination record for R20 shows loose stools on the following dates:

• October 26, 2020 at 9:50 a.m.
• October 27, 2020 at 8:52 p.m. 

CMS Ex. 35 at 34.

Page 48

An October 29, 2020 progress note indicated that R20 had experienced loose stools in the last 30 days, that R20’s physician and family were notified, and that a COVID test was negative.  CMS Ex. 35 at 3.

Because R20 did not have three loose stools in a 24-hour period, R20 did not have the COVID symptom of diarrhea.  Therefore, the COVID ICP did not require Petitioner to establish transmission-based precautions.

R22

The SOD stated the following as to R22:

R22’s progress notes identified between 10/8/20 and 10/10/20, and again on 10/19/20, R22 had loose stools.  R22’s COVID Screening tool made no mention R22 experienced loose stools and identified “no precautions” were needed, but no explanation was provided as to why staff had determined potential symptoms had not required quarantine or [transmission-based precautions].

CMS Ex. 1 at 15.

At the time of the survey that ended on November 2, 2020, R22 was a 93-year-old woman who was admitted to the facility in June 2020 with diagnoses that included constipation, chronic kidney disease, and essential hypertension.  CMS Ex. 36 at 1-2.

The CDC consistently listed diarrhea as a COVID-19 symptom.  CMS Ex. 47 at 1; CMS Ex. 48 at 5; CMS Ex. 50 at 2.

The bowel elimination record for R22 shows loose stools on the following dates:

• September 30, 2020 at 1:59 p.m.
• October 8, 2020 at 11:30 a.m.
• October 9, 2020 at 1:59 p.m.
• October 10, 2020 at 9:39 a.m.
• October 10, 2020 at 9:03 p.m.
• October 19, 2020 at 11:54 a.m. 

P. Ex. 117 at 28-29; CMS Ex. 36 at 68-69.

Page 49

Because R22 did not have three loose stools in a 24-hour period, R20 did not have the COVID symptom of diarrhea.  Therefore, the COVID ICP did not require Petitioner to establish transmission-based precautions.

R24

The SOD stated the following as to R24:

R24’s progress notes identified between 10/5/20 and 10/20/20, R24 experienced COVID symptoms of cough, congestion, headache and sore throat.  R24’s Covid Screening Tool identified R2[4] had no symptoms of COVID checked on the tool and identified “no precautions” were needed.  On 11/1/20, R24 was tested for COVID and had a positive result and was first placed on quarantine with [transmission-based precautions] at that time after testing positive.

CMS Ex. 1 at 15-16.

At the time of the survey that ended on November 2, 2020, R24 was an 88-year-old woman who was admitted to the facility in January 2019, with diagnoses that included dementia, chronic diastolic (congestive) heart failure, edema, GERD without esophagitis, and chronic obstructive pulmonary disease.  CMS Ex. 37 at 1-2.

The CDC listed nausea, vomiting, diarrhea, fatigue, muscle and body aches, cough, congestion or runny nose, sore throat, new dizziness, and headache as COVID-19 symptoms.  CMS Ex. 47 at 1; CMS Ex. 48 at 5; CMS Ex. 50 at 2.

R24’s progress notes indicate R24 had the following symptoms:

• October 5, 2020 - sore throat
• October 8, 2020 – headache
• October 9, 2020 - headache
• October 10, 2020 - cough
• October 13, 2020 – headache
• October 16, 2020 – headache
• October 18, 2020 – headache
• October 20, 2020 - sore throat 

CMS Ex. 37 at 4-6.

Page 50

A November 1, 2020 progress note stated that R24 started to have symptoms for COVID-19 and a rapid COVID test was positive.  CMS Ex. 37 at 3.  Additional progress notes for November 1, 2020, state that R24 complained of a sore throat, was moved to a private room for isolation, and later moved to a resident COVID unit.  CMS Ex. 37 at 3.

Petitioner failed to fully implement its COVID ICP because R24 had three symptoms of COVID-19 and Petitioner did not timely establish transmission-based precautions for R24, rather waiting weeks to do so following a positive COVID test.

R26

The SOD stated the following as to R26:

R26’s progress notes identified between 10/21/20 and 10/30/20, R26 experienced increased frequency of headaches.  R26 also reported her eyes “hurting”.  R26’s COVID Screening tool identified R26 had no symptoms of COVID, and no precautions were required.  Additionally, the notes made no mention R26 was tested for COVID, or whether placed on quarantine with [transmission-based precautions] at the onset of her increased frequency of headache.

CMS Ex. 1 at 16.

At the time of the survey that ended on November 2, 2020, R26 was a 69-year-old woman who was admitted to the facility on September 18, 2020, with diagnoses that included paranoid schizophrenia and GERD without esophagitis.  CMS Ex. 38 at 1-2.

The CDC listed nausea, vomiting, diarrhea, fatigue, muscle and body aches, cough, congestion or runny nose, sore throat, new dizziness, and headache as COVID-19 symptoms.  CMS Ex. 47 at 1; CMS Ex. 48 at 5; CMS Ex. 50 at 2.

Progress notes on the following dates indicate that R26 had a headache:  October 21-22, 24-25, 27, 30, 2020.  CMS Ex. 38 at 3-7.

Headache is a symptom of COVID-19.  There is no evidence in the record that Petitioner’s staff fully implemented the COVID ICP and indicated on the relevant COVID screening tools that R26 had headaches.  However, Petitioner was not required to establish transmission-based precautions for R26 because there was only one symptom.

R27

The SOD stated the following as to R27:

Page 51

R27’s progress notes identified between 10/19/20 and 10/21/20, R27 had intermittent loose stools.  On 10/28/20, R27 was tested and found positive for COVID.  R27 was admitted to hospice care.  The notes made no mention R27 was placed on quarantine with [transmission-based precautions] at the onset of potential COVID symptoms.

CMS Ex. 1 at 16.

At the time of the survey that ended on November 2, 2020, R27 was a 66-year-old man who was admitted to the facility on September 29, 2020, with diagnoses that included dementia, encephalopathy, scabies, and vitamin B12 deficiency anemia.  CMS Ex. 39 at 1-2.

The CDC consistently listed diarrhea as a COVID-19 symptom.  CMS Ex. 47 at 1; CMS Ex. 48 at 5; CMS Ex. 50 at 2.

The bowel elimination record for R27 shows loose stools on the following dates:

• October 19, 2020 at 1:59 p.m.
• October 21, 2020 at 5:49 a.m.
• October 28, 2020 at 1:59 p.m. 

CMS Ex. 39 at 18.

Because R27 did not have three loose stools in a 24-hour period, R27 did not have the COVID symptom of diarrhea.  Therefore, the COVID ICP did not require Petitioner to establish transmission-based precautions.

R29

The SOD stated the following as to R29:

R29’s progress notes identified between 10/29/20 and 11/1/20, R28 experienced loose stools, dizziness, fatigue, and headache.  On 10/30/20, R28 did have a COVID test which was negative.  Staff continued to monitor for symptoms of COVID.  R28’s COVID Screening Tool assessments identified R29 had no symptoms of COVID, and R29 did not “require isolation”.  The notes made no mention how staff had determined no quarantine or [transmission-based

Page 52

precautions] were required at the onset of potential symptoms.

CMS Ex. 1 at 16.

At the time of the survey that ended on November 2, 2020, R29 was a 73-year-old man who was admitted to the facility in January 2020, with diagnoses that included acute kidney failure, rhabdomyolysis, and dementia.  CMS Ex. 40 at 1-2.

The CDC listed nausea, vomiting, diarrhea, fatigue, muscle and body aches, cough, congestion or runny nose, sore throat, new dizziness, and headache as COVID-19 symptoms.  CMS Ex. 47 at 1; CMS Ex. 48 at 5; CMS Ex. 50 at 2.

The bowel elimination record for R29 shows loose stools on the following dates:

• October 10, 2020 at 9:02 p.m.
• October 30, 2020 at 8:00 p.m.
• November 1, 2020 at 7:08 p.m. 

CMS Ex. 40 at 36, 38.

Petitioner’s staff completed COVID-19 screening tool documents from October 29-October 31, 2020.  CMS Ex. 40 at 39-47.  Staff only noted on the October 30, 2020 screening tools that there were symptoms.  Specifically, on October 30, 2020, at 12:42 a.m., 9:30 a.m., and 4:26 p.m., the COVID screening tool indicates that R29 had the symptom of nasal congestion but that isolation was not necessary.  CMS Ex. 40 at 42-44.

Progress notes from October 29, 2020, state that R29 had loose stools in the last 30 days, that R29’s physician was informed, and that R29 tested negative for COVID.  CMS Ex. 40 at 4.

An October 30, 2020 progress note states that R29 was dizzy and complained of a headache; however, a COVID test produced negative results.  CMS Ex. 40 at 3.

Progress notes from November 1, 2020 state that R29 had a loose stool and was fatigued; however, another COVID test was negative.  CMS Ex. 40 at 3.

Although R29’s loose stool was not technically a COVID symptom because all three incidents did not occur within a 24-hour period, Petitioner documented that R29 had congestion, dizziness, headache, and fatigue.  Petitioner did not fully implement its COVID-19 ICP because it did not establish transmission-based precautions for R29 after R29 had at least two COVID-19 symptoms.

Page 53

R33

The SOD stated the following as to R33:

R33’s progress notes identified between 10/4/20 and 10/28/20, R33 experienced intermittent loose stools.  R33’s COVID Screening Tool made no mention R33 had these loose stools, and identified “no precautions” were required.  The notes made no mention how staff determined no [transmission-based precautions] were required at the onset of potential symptoms.  As such, no quarantine or [transmission-based precautions] were implemented.

CMS Ex. 1 at 16-17.

At the time of the survey that ended on November 2, 2020, R33 was a 90-year-old woman who was admitted to the facility in January 2019, with diagnoses that included dementia, acute kidney failure, adult failure to thrive, and hypertensive heart disease with heart failure.  CMS Ex. 41 at 1-2.

The CDC consistently listed diarrhea as a COVID-19 symptom.  CMS Ex. 47 at 1; CMS Ex. 48 at 5; CMS Ex. 50 at 2.

The bowel elimination record for R33 shows loose stools on the following dates:

• October 4, 2020 at 12:26 p.m.
• October 4, 2020 at 8:31 p.m.
• October 5, 2020 at 4:26 a.m.
• October 6, 2020 at 4:04 a.m.
• October 6, 2020 at 6:25 p.m.
• October 8, 2020 at 1:59 p.m.
• October 13, 2020 at 7:33 p.m.
• October 15, 2020 at 5:00 p.m.
• October 17, 2020 at 1:55 p.m.
• October 20, 2020 at 6:20 p.m.
• October 21, 2020 at 7:06 p.m.
• October 27, 2020 at 7:11 p.m.
• October 28, 2020 at 6:49 p.m.

CMS Ex. 41 at 30-31.

Page 54

Progress notes entered on October 29, 2020, state that R33 experienced loose stools within the last 30 days, that R33’s physician was notified, and that R33 tested negative for COVID-19.  CMS Ex. 41 at 3.

Because R33 had three loose stools within a 24-hour period from October 4-5, 2020, R33 had diarrhea.  Petitoner’s staff failed to fully implement the COVID ICP because there is no evidence that Petitioner’s staff recorded this COVID symptom on the relevant screening tools they were creating.  However, under the COVID ICP, Petitioner was not required to establish transmission-based precautions for R33 when there was only one symptom.

R34

The SOD stated the following as to R34:

R34’s progress notes identified between 10/4/20 and 10/29/2[0], R24 experienced loose stools.  Between 10/27/20 and 11/1/20, R34 experienced an upset stomach and decreased appetite.  Although R34 was tested 11/1/20, with negative results, prior to testing, the notes made no mention whether R34 was placed on quarantine with [transmission-based precautions] when the diarrhea and upset stomach (potential COVID symptoms) developed.

CMS Ex. 1 at 17.

At the time of the survey that ended on November 2, 2020, R34 was a 67-year-old woman who was admitted to the facility in April 2008, with diagnoses that included schizoaffective disorder, type 2 diabetes, and polyosteoarthritis.  CMS Ex. 42 at 1-2.

The CDC listed nausea, vomiting, diarrhea, fatigue, muscle and body aches, cough, congestion or runny nose, sore throat, new dizziness, and headache as COVID-19 symptoms.  CMS Ex. 47 at 1; CMS Ex. 48 at 5; CMS Ex. 50 at 2.

The bowel elimination record for R34 shows loose stools on the following dates:

• October 4, 2020 at 9:59 p.m.
• October 8, 2020 at 11:21 a.m.
• October 10, 2020 at 9:08 p.m.
• October 25, 2020 at 9:37 p.m.
• October 29, 2020 at 1:59 p.m. 

CMS Ex. 42 at 18-19.

Page 55

A progress note entered on October 27, 2020, stated that R34 refused to eat supper.  CMS Ex. 42 at 3.  A progress note entered on October 29, 2020, stated that Tylenol was given to R34 due to a complaint of abdominal pain.  CMS Ex. 42 at 3.  A progress note on November 1, 2020, stated that R34 showed one or more symptoms of COVID-19 and that a COVID test was negative.  CMS Ex. 42 at 3.

R34 did not have three loose stools in a 24-hour period; therefore, R34 did not have diarrhea.  Further, R34’s complaint of abdominal pain does not appear on CDC’s list of COVID symptoms; however, even if it did, Petitioner was not obligated under the COVID ICP to establish transmission-based precautions for R34 when there is only one symptom of COVID-19.

R38

The SOD stated the following as to R38:

R38’s progress notes identified between 10/27/20 and 10/30/20, R38 experienced intermittent loose stools.  The notes made no mention whether R33 was placed on quarantine or [transmission-based precautions] when the diarrhea developed.

CMS Ex. 1 at 17.

At the time of the survey that ended on November 2, 2020, R38 was a 73-year-old man who was admitted to the facility in June 2019, with diagnoses that included dementia, Alzheimer’s disease, GERD without esophagitis, constipation, chronic obstructive pulmonary disease, and diverticulitis of large intestine without perforation or abscess without bleeding.  CMS Ex. 43 at 1-2.

The CDC consistently listed diarrhea as a COVID-19 symptom.  CMS Ex. 47 at 1; CMS Ex. 48 at 5; CMS Ex. 50 at 2.

The bowel elimination record for R38 shows loose stools on the following dates:

• October 27, 2020 at 7:10 p.m.
• October 28, 2020 at 3:55 p.m.
• October 30, 2020 at 9:59 p.m. 

CMS Ex. 43 at 8-9.

Page 56

Progress notes entered on October 29, 2020, state that R38 has experienced loose stools within the last 30 days, that R38’s physician was notified, and that R38 tested negative for COVID-19.  CMS Ex. 43 at 3.

A progress note entered on October 30, 2020, states that R38’s family stated that R38 had a partial colon removal and that he has a history of going from constipation to loose stools.  CMS Ex. 43 at 3.

R38 did not have three loose stools within a 24-hour period.  Therefore, R38 did not have diarrhea or other COVID-19 symptoms, and Petitioner was not obligated under the COVID ICP to establish transmission-based precautions.

11. Petitioner was not in substantial compliance with infection control regulations at 42 C.F.R. § 483.80(a)(1)-(2) (F-Tag 880) because facility staff failed to fully implement Petitioner’s ICP.  For seven residents, Petitioner’s staff failed to establish transmission-based precautions after those residents manifested two or more symptoms of COVID-19.  Further, for an additional seven residents, Petitioner’s staff failed to document on Petitioner’s COVID-19 screening tool that the residents had COVID-19 symptoms.  Failing to fully implement the ICP risked the spread of COVID-19 in the facility.

As discussed above, the Act states that an SNF must:

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); see also 42 C.F.R. § 483.80.  The Secretary’s regulations require facilities to establish and maintain an ICP that includes, among other things, a “system for preventing, identifying, reporting, investigating, and controlling infections and communicable diseases for all residents, staff, volunteers, visitors, and other individuals providing services under a contractual arrangement based upon the facility assessment conducted according to § 483.70(e) and following accepted national standards.”  42 C.F.R. § 483.80(a)(1).  The statutory and regulatory mandate to “establish and maintain” an ICP requires SNFs to not only adopt an appropriate ICP, but also to implement the ICP’s prescribed precautions.  Golden Living Ctr. - Superior, DAB No. 2768 at 7 (2017) (citing Heritage House of Marshall Health & Rehab. Ctr., DAB No. 2566 at 12 (2014)).

As discussed in detail in FFCL 10, the SOD alleged that Petitioner failed to fully implement its COVID ICP for 24 residents when Petitioner did not establish transmission-based precautions for those residents after they manifested one or more 

Page 57

symptoms of COVID-19 and/or failed to note COVID-19 symptoms on Petitioner’s COVID screening tool.  The SOD did not allege that Petitioner’s ICP failed to meet regulatory requirements for ICPs; therefore, I was bound to apply the provisions of the ICP to determine if Petitioner was in substantial compliance with 42 C.F.R. § 483.80 (i.e., did Petitioner maintain or implement the ICP as it was written).

The primary provision of Petitioner’s COVID ICP that I applied stated:

If a resident has symptoms consistent with COVID-19 . . . he or she should be placed on or remain on [transmission-based precautions] until he or she meets the symptom-based criteria for discontinuation.

CMS Ex. 16 at 14.  Because the ICP used the plural term “symptoms,” Petitioner’s screening tool interpreted this provision as requiring two or more symptoms.  CMS did not contest this interpretation of the provision and of the term “symptoms.”  Thus, I applied a standard that transmission-based precautions were only required when a resident had more than one COVID symptom.  As a result, I only found that Petitioner violated the ICP for seven of the residents under this standard.  Under a different provision in the ICP, I also found that Petitioner failed to fully implement the ICP for seven other residents because staff failed to note on the facility’s COVID screening tool that those residents had a COVID-19 symptom.  However, I also found in those cases the ICP did not require the establishment of transmission-based precautions because the residents did not have two or more symptoms.

Because Petitioner failed to fully implement its COVID ICP, as described in detail in FFCL 10, I conclude that Petitioner was not in substantial compliance with 42 C.F.R. § 483.80.

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

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

I must uphold CMS’s determination as to the level of a facility’s noncompliance (which includes an immediate jeopardy finding) unless it is “clearly erroneous.”  42 C.F.R. § 498.60(c).  The “clearly erroneous” standard imposes on facilities a heavy burden to show no immediate jeopardy, and determinations of immediate jeopardy have been sustained where CMS presented evidence “from which ‘[o]ne could reasonably conclude’

Page 58

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

In the present case, Petitioner failed to fully implement its COVID ICP when it did not place 17 residents under transmission-based precautions after they were exposed to a COVID-positive staff member and when it did not place seven residents under transmission-based precautions after they manifested two or more symptoms of COVID-19.  Therefore, the primary threat was that individuals who may be infected with COVID-19 were able to spread the virus further throughout the facility.

Nurse Osterloh testified to the risks involved when Petitioner failed to establish transmission-based precautions:

In my professional opinion, when a facility delays implementing transmission[-]based precautions it increases the risk that an infectious disease, like Covid-19, will spread to another resident or staff.  The standard of care requires the implementation of transmission-based precautions immediately, as opposed to waiting for a diagnostic test, because the test results for Covid-19 can take days to return. During this intervening time period, the absence of precautions presents an opportunity for a contagious, but undiagnosed, resident to expose staff and other residents to the virus, thus fostering transmission within the facility.

CMS Ex. 56 ¶ 14.  As to immediate jeopardy, Nurse Osterloh testified as follows:

I took part in the immediate jeopardy determination[,] and it is my professional opinion that Crossroads’ noncompliance posed an immediate jeopardy.  The immediate jeopardy began on September 17, 2020 when Crossroads learned that at least twenty residents had a known exposure to a staff member with Covid-19 but the facility did not implement transmission-based precautions.  The immediate jeopardy was removed on October 30, 2020, during the survey, although noncompliance continued thereafter.  The facility’s failures to immediately implement the necessary precautions increased the likelihood that Covid-19 would spread among the

Page 59

residents.  Covid-19 is particularly dangerous for older people living in an institutional setting like a long[-]term care facility.  Covid-19 spreads quickly and easily, especially in an institutional setting where staff are in close contact with residents, are providing hands-on care, and are moving between residents’ rooms, all of which further increases the likelihood of exposure and infection.  Covid-19 is also more likely to cause serious illness and death in older populations.  Many residents in long[-]term care facilities have existing health conditions that are exacerbated by Covid-19 and make recovery more difficult or unlikely.

CMS Ex. 56 ¶ 18.  Nurse Osterloh’s testimony is consistent with the CDC’s assessment, described above in FFCL 2, which stated how easily COVID-19 can spread in SNFs and that the elderly are more likely to have negative outcomes, such as death, than other groups.

While trying to argue that the unprecedented nature of the COVID pandemic is a defense to the deficiencies found by the state agency, Petitioner’s argument actually shows that it needed to scrupulously follow its COVID ICP to try to avoid the spread of this virus which, at the time this took place, was particularly able to spread in SNFs and was particularly deadly to SNF populations.  Petitioner argued:

This tribunal may take judicial notice that in 2020 the COVID-19 pandemic was unprecedented, and the few tools providers had to combat or prevent outbreaks were not perfect.  In 2020 there were no vaccines.  Testing was sparce, as was PPE.  There was no Paxlovid.  Asymptomatic carriers could transmit the virus.  Minnesota’s skilled nursing facilities, including Crossroads, were not equipped, prepared, or able to control a deadly respiratory virus that spreads through the air via asymptomatic carriers.  In 2020, Minnesota skilled facilities, just like other health care providers in Minnesota, lacked effective screening tools for COVID-19 or reliable labs that could turn test results around quickly.  Guidance from the Center for Disease Control (“CDC”) to senior centers was changing rapidly.  The CDC’s COVID-19 guidance was often couched as suggestions, as contrasted with the enforceable mandates of F880 and F882’s infection control guidelines required by 42 CFR 483.80. 

When it comes to curtailing contagions, Minnesota’s licensure requirements for nursing home buildings are

Page 60

significantly different than hospitals.  Minnesota licensing rules require hospitals to have isolation rooms, suites, or contagion units.  The ventilation requirements are more robust for hospitals than nursing homes.  

CMS’s standard infection control procedures, including screening and identifying symptoms, were designed to protect residents from easily detectible, symptomatic transmission of typical contagions, like the flu.  COVID-19’s asymptomatic transmission rendered routine infection control procedures ineffective.  Even after vaccines became available much later, some pandemic infection experts believed fully vaccinated asymptomatic individuals still posed a risk of transmission of the COVID-19 virus.

P. Br. at 11 (internal citations omitted).  Petitioner’s arguments are all true.  And while Petitioner’s facility suffered an outbreak where many residents were infected with COVID, that fact is not the focus of this case.  As Petitioner’s expert witness, Nurse Lindahl testified, an SNF could follow all of the guidelines and still not keep COVID out of a facility.

So we were dealing with a virus, as I said, the greatest scientists in the world couldn’t figure out and couldn’t stop it worldwide, so if a nursing home is doing everything that they’re supposed to do and only half of the people get it, I’d say, yeah, they did a pretty darn good job, because you would expect then 100 percent of them to get it.

Tr. 141: 14-19.

I accept this testimony that it was possible for an SNF to fully comply with its ICP and still suffer an outbreak.  However, the reason for a finding of substantial noncompliance was the failure to fully implement the ICP, i.e., a failure to do everything required “to help prevent the development and transmission of disease and infection.”  42 U.S.C. § 1395i-3(d)(3)(A).

Nurse Surveyor Osterloh testified that the September 17, 2020 positive test for NA-D showed a problem with the implementation of the ICP:

Q.  [W]hy was the [immediate jeopardy] called and determined to have begun on September 17th? 

Page 61

A.  That was when we could see their -- really, their system breakdown.  They did not have a good system for surveillance, and that was the first instance where we could show that those residents should have been put in a transmission-based precautions protectively to mitigate factors for the spread of this very large outbreak that happened in the facility. 

Q.  So is it relevant to the IJ determination that no resident actually tested positive within the first two weeks after this exposure?

A.  No.

Q.  Could you explain why it’s not relevant?

A.  It’s not relevant in, per se, as far as if that was the sole factor, no.  The relevancy in that is to show the system breakdown, where we’re, you know, what was kind of where we saw the first problem with that.  And again, it had to deal with the surveillance aspect because the, the staff person did not make their surveillance, they did not implement proactively, transmission-based precautions for a known exposure to those residents.

Tr. 58.  Therefore, the immediate jeopardy situation in this case is clear from the relatively wide-spread failure in September and October 2020 of the facility to implement the ICP provisions that required transmission-based precautions to be established for residents exposed to COVID-19 or manifesting two or more symptoms of COVID-19.  Any or all of these residents could spread COVID-19 to residents or staff at the facility.  Based on the significant threat COVID-19 posed to the elderly, I cannot conclude that CMS was clearly erroneous when it determined that Petitioner’s noncompliance with 42 C.F.R. § 483.80 immediately jeopardized the health and safety of residents.

Respiratory Illness Reporting

13. From November 1 through November 16, 2020, 22 residents at Petitioner’s facility tested positive for COVID-19.  During that time, the facility only sent automated messages to the families/representatives for all residents on November 3, 6, and 12, 2020, informing them of the new positive tests results for COVID-19 among the facility’s residents.

Page 62

Following the outbreak of COVID-19 infections at the facility in October 2020, Petitioner’s staff monitored residents and tested them for COVID-19 when relevant symptoms were present.  CMS Ex. 53.  The following list includes the residents and dates of COVID testing that returned a positive result.9

• R24:..November 1, 2020
• R10:  November 2, 2020
• R39:  November 2, 2020
• R22:  November 2, 2020
• R12:  November 2, 2020
• R37:  November 3, 2020
• R36:  November 3, 2020
• R30:  November 3, 2020
• R16:  November 3, 2020
• R20:  November 3, 2020
• R29:  November 4, 2020
• R27:  November 4, 2020
• R26:  November 5, 2020
• R19:  November 5, 2020
• R38:  November 6, 2020
• R32:  November 6, 2020
• R21:  November 9, 2020
• R35:  November 9, 2020
• R3:   November 10, 2020
• R18:  November 11, 2020
• R31:  November 13, 2020
• R17:  November 16, 2020

CMS Ex. 53 at 1-2; see also CMS Ex. 51.

On the same day when Petitioner’s staff received a positive test result, they would contact the family/representative of the resident who tested positive.  Petitioner also would send an automated notice to all of the residents’ families/representatives to inform them that a resident at the facility tested positive for COVID-19.  However, these automated notices to all of the residents’ family/representatives were not always done by the next day following the positive test result of each resident.  CMS Ex. 57 ¶ 6.

Page 63

Petitioner provided automated notice to all residents’ families/representatives that one or more residents had tested positive for COVID-19 on October 28, 2020, November 3, 2020, November 6, 2020, November 12, 2020, and November 23, 2020.  CMS Ex. 57 ¶ 6.  The automated messages were automated phone calls or emails.  CMS Ex. 52 at 17-22; Tr. 85.  The messages provided the following notice:

• The October 28, 2020 automated message informed families/representatives for facility residents that “we currently have COVID positive residents in the building.”  CMS Ex. 52 at 22.
• The November 3, 2020 automated message informed families/representatives for facility residents that, “we are still experiencing an outbreak from COVID-19.  We currently have 13 positive residents. . . .  The people that are positive are placed in isolation and we are monitoring all residents closely.”  CMS Ex. 52 at 21.
• The November 6, 2020 automated message informed families/representatives for facility residents that, “we are getting more and more positive residents but beginning today we have people coming out of isolation and recovering!”  CMS Ex. 52 at 20.
• The November 12, 2020 automated message informed families/representatives for facility residents of the following:  “We have officially recovered 16 residents from the COVID-19 infection.  Even though we continue to get positive resident things are starting to look up, although the hard work continues.  We are continuing to still test twice a week for all staff and residents that are still negative.”  CMS Ex. 52 at 19-20.  
• The November 23, 2020 automated messages informed families/representatives for the facility residents of the following:  “As of today, we have one person left in isolation related to COVID-19.  We have 33 recovered residents!”  CMS Ex. 52 at 17-19.

14. Petitioner was not in substantial compliance with 42 C.F.R. § 483.80(g)(3) because it failed to timely inform all of the families/representatives for the residents in the facility when each facility resident in November 2020 tested positive.

During a COVID-19 Focused Infection Control survey conducted on November 24 and 25, 2020, to determine compliance with section 483.80, a state agency surveyor,

Page 64

Stacy Haag, RN,10 concluded that Petitioner “failed to substantially comply with 42 C.F.R. § 483.80(g)(3) [tag 885] by not timely informing representatives or families after confirmed infections of COVID-19.”  CMS Ex. 57 ¶ 5; CMS Ex. 3.

In November 2020, SNF’s were required to:

(3)  Inform residents, their representatives, and families of those residing in facilities by 5 p.m. the next calendar day following the occurrence of either a single confirmed infection of COVID-19, or three or more residents or staff with new-onset of respiratory symptoms occurring within 72 hours of each other.  This information must –

(i) Not include personally identifiable information;

(ii) Include information on mitigating actions implemented to prevent or reduce the risk of transmission, including if normal operations of the facility will be altered; and

(iii) Include any cumulative updates for residents, their representatives, and families at least weekly or by 5 p.m. the next calendar day following the subsequent occurrence of either:  Each time a confirmed infection of COVID-19 is identified, or whenever three or more residents or staff with new onset of respiratory symptoms occur within 72 hours of each other. 

42 C.F.R. § 483.80(g)(3) (emphasis added).11

It is evident that Petitioner’s ICP in effect in November 2020 included this regulatory requirement.  Facility staff were to inform the families/responsible party of each resident when the resident was tested for COVID-19 and also when the results of the test were received.  In addition, staff was instructed that, “[i]f the results are positive, notification to the families by the 5:00pm the next day.  Notification should include:  any resident with a positive result, or 3 or more residents or staff with signs/symptoms occurring within 72 hours of each other. . . .  In the notification, it should include any changes the facility took to mitigate the spread i.e., establishment of COVID wing/unit, isolations

Page 65

precautions etc. . . .  The facility notifications will occur as often as necessary but no less than weekly.”  CMS Ex. 16 at 7-8, 12.

Nurse Haag testified that Petitioner’s “Director of Nursing told me that [Petitioner] had notified families of the first seven positive tests by 5 p.m. the next day (October 28).  However, she confirmed that [Petitioner] did not notify all families and representatives after each positive test by 5 p.m. the next day.”  CMS Ex. 57 ¶ 6; Tr. 85.

Nurse Haag testified that Petitioner’s staff was calling the families of residents who had tested positive to inform them of that; however, Petitioner’s staff was not informing the families of non-positive residents that other residents tested positive.  Tr. 80-81, 84-85.  Surveyor Haag testified that Petitioner was supposed to notify the families of the non-positive residents that other residents tested positive by 5 p.m. the day after the positive test was received; however, Petitioner was not doing this.  Tr. 84-85.

Nurse Lindahl testified that she disagreed with Nurse Haag’s conclusion that Petitioner failed to properly notify resident families/representatives.  P. Ex. 101 ¶ 31.  However, Nurse Lindahl cites the individual record of a resident showing that, on September 17, 2020, facility staff had called families to alert them to a COVID-positive test result.  P. Ex. 101 ¶ 31.  Further, Nurse Lindahl testified that this deficiency is premised on residents having symptoms of COVID that may have only been baseline conditions for those residents.  P. Ex. 101 ¶ 32.  Petitioner primarily argues that it was in substantial compliance based on Nurse Lindahl’s testimony.  P. Br. at 18-19.

I reject Nurse Lindahl’s testimony and, by extension, Petitioner’s argument.  CMS’s position is that Petitioner tested residents and received COVID-positive test results but failed to timely (i.e., by 5 p.m. the following day) inform the families/representative of all the residents in the facility.  As found above, from November 1 through 16, 2020, Petitioner received 22 positive COVID test results, yet during that time, Petitioner only issued automated notices on November 3, 6, and 12, 2020.  There is no way possible that Petitioner’s sporadic notices resulted in the timely notification for all of the 22 COVID positive results.  Indeed, the November 13 and 16, 2020 positive results do not appear to have been reported to the families/representatives of the residents at all.  Ms. Haag testified that Petitioner’s DON admitted that notice was not always provided in a timely manner, and Petitioner did not submit written direct testimony from the DON to refute this testimony; therefore, I accept it as true.  See Beatrice State Developmental Ctr., DAB No. 2311 at 17-18 (2010).

In addition, I note that the notices Petitioner did send lacked detail and did not state the number of positive test results.  If those notices complied with section 483.80(g)(3), it would be by the barest of margins.

Page 66

Therefore, I conclude that Petitioner was not in substantial compliance with 42 C.F.R. 483.80(g)(3).

Duration and CMP Amount

15. Petitioner failed to meet its burden under 42 C.F.R. § 488.454(e) to provide acceptable documentation to show that it was both in substantial compliance with Medicare requirements and could maintain substantial compliance with Medicare requirements on a date earlier than December 30, 2020.

On December 30, 2020, the state agency conducted a revisit survey at Petitioner’s facility and determined that Petitioner had returned to substantial compliance with Medicare program participation requirements on that date.  CMS Ex. 5 at 1; CMS Ex. 6 at 2.  Based on this finding, CMS determined that the DPNA would be in effect from December 5, 2020 through December 29, 2020, and the CMPs would commence on October 27, 2020, and end on December 29, 2020.  CMS Ex. 6 at 2.

Petitioner argues that it returned to substantial compliance at an earlier date based on the state agency survey completed on November 25, 2020.

CMS witness Stacy Haag testified that she conducted the second survey that ended on November 25, 2020.  Tr. 76:17-21.  She conceded that as a surveyor, it is her responsibility to identify all deficiencies that she observes while in the building.  Tr. 77:22-25; 78:1.  When she entered the building on November 24, 2020, Ms. Haag testified that she was “expecting to review” both tags “F-880 and 885.”  Tr. 78:21-23.  Ms. Haag conceded she did not cite any deficiency under F-880 during the second survey.  Tr. 78:7-10. 

To the contrary, Ms. Haag’s interviews revealed that the Crossroads made substantial progress to meet MDH’s satisfaction well before its December 7, 2020 date of completion.  Tr. 80:6-15.  Ms. Haag testified that she “reviewed infection control practices that I observed out on the floor and interviews of staff to assure that proper isolation and PPEUs [transcription errata: PPE use] was being utilized.  And reviewed their logs . . . related to COVID, their infection control logs, and saw that they were implementing some of those things that they identified they were going to [do]. . . .”  Crossroads staff told Ms. Haag “[T]hat they were not completed yet.”  Tr. 80:8-15.  Staff expected to have until

Page 67

December 7, 2020 to implement its plan of correction.  P. Ex. 100 ¶¶ 16-17; N. Osterloh, Tr. 53:7-13.

Given that the second November 25 survey did not find or cite an F-880 deficiency, and in light of the substantial compliance witnessed and testified to by Ms. Haag, any CMP should end on November 25, 2020, and not 35 days later on December 30, 2020 when MDH sent another team into Crossroads to revisit.  CMS Ex. 5, p. 1 (“On December 30, 2020 [MDH] completed a revisit. . . . ”).  In light of the testimony regarding the November 25, 2020 survey, there is no basis to impose a DDPNA beginning December 5, 2020.

P. Br. at 20.

Surveyor Haag testified that the November 24-25, 2020 survey was not a follow-up survey to the survey ending November 2, 2020.  Tr. 78.  Surveyor Haag’s survey considered Tags F880 (42 C.F.R. § 483.80(a)) and F885 (42 C.F.R. 483.80(g)); however, she only found a deficiency with F885.  Tr. 78-79.  Surveyor Haag testified that Petitioner had not yet completed its plan of correction, and she was there because the state agency’s REDCap identified Petitioner as having another outbreak.  Tr. 79; see also Tr. 53-54, 65.  If a facility reported three or more COVID cases to the state agency, then a surveyor had to go to the facility within three to five days.  Tr. 65, 82.  Surveyor Haag stated that, during her survey, Petitioner had made progress concerning the infection control deficiency but did not state that it had achieved substantial compliance.  Tr. 80.

Once a state agency finds an SNF to be noncompliant with Medicare program participation requirements, the SNF remains so until it affirmatively demonstrates that it has achieved substantial compliance once again.  Ridgecrest Healthcare Ctr., DAB No. 2493 at 2-3 (2013); Taos Living Ctr., DAB No. 2293 at 20 (2009); Premier Living & Rehab Ctr., DAB No. 2146 at 3 (2008); Lake City Extended Care Ctr., DAB No. 1658 at 12-15 (1998).  Enforcement remedies continue until the state agency determines that the SNF has returned to substantial compliance during a revisit survey or by “credible written evidence that [CMS or the state agency] can verify without an on-site visit.”  42 C.F.R. § 488.454(a)(1).  During a “revisit survey,” state surveyors must “evaluate the extent to which previously-cited deficiencies have been corrected and the provider or supplier is in substantial compliance with applicable conditions of participation, requirements, or conditions for coverage.”  42 C.F.R. § 488.30(a) (Emphasis added).

The SNF bears the burden of showing that its noncompliance was of a shorter duration than found by CMS.  Owensboro Place & Rehab. Ctr., DAB No. 2397 at 12 (2011) (citing Kenton Healthcare, LLC, DAB No. 2186 at 24-25 (2008) and Lake Mary Health Care, DAB No. 2081 at 30 (2007)).  Therefore, the burden is on the SNF to prove that it

Page 68

returned to substantial compliance and CMS does not need to prove that deficiencies continued to exist.  Asbury Care Ctr. at Johnson City, DAB No. 1815 at 19-20 (2002).

If an SNF believes that enforcement remedies should end on a date earlier than the revisit survey, then Petitioner must meet the following regulatory requirement:

If the facility can supply documentation acceptable to CMS or the State survey agency that it was in substantial compliance and was capable of remaining in substantial compliance, if necessary, on a date preceding that of the revisit, the remedies terminate on the date that CMS or the State can verify as the date that substantial compliance was achieved and the facility demonstrated that it could maintain substantial compliance, if necessary.

42 C.F.R. § 488.454(e) (Emphasis added); see also Ridgecrest Healthcare Ctr., DAB No. 2493 at 15 (2013) (“As the Board has recognized, a [plan of correction] indicating a specific date of implementation is not sufficient evidence by itself to establish that the measures in the [plan of correction] had been satisfactorily implemented.”); Oceanside Nursing & Rehab. Ctr., DAB No. 2382 at 20 (2011) (“Even if a [plan of correction] is accepted, the facility is not regarded as in substantial compliance until CMS determines, ‘usually through a revisit survey,’ that the deficiency no longer exists.”).  Therefore, in order for me to reduce the duration of the noncompliance, in this case, Petitioner must show that it not only returned to substantial compliance before the revisit survey but also that there is sufficient evidence that Petitioner could maintain substantial compliance.

Petitioner cannot meet this burden.  As an initial matter, Petitioner’s only evidence is the second survey that was completed on November 25, 2020.  However, this survey found that Petitioner was noncompliant with 42 C.F.R. § 483.80(g)(3).  CMS Exs. 3-4.  Therefore, this survey proves that Petitioner could not maintain substantial compliance with Medicare program participation requirements following the original survey that ended on November 2, 2020.  Further, Petitioner’s plan of correction did not estimate completion until December 7, 2020.  CMS Ex. 1 at 2, 5, 7, 11.  And CMS is well within its authority to wait additional time to determine a return to compliance after that estimated date the plan of correction will be completed.  See Oceanside Nursing & Rehab. Ctr., DAB No. 2382 at 17 (2011) (“since they operated prospectively, CMS could reasonably require evidence that the new practices and requirements were actually put into effect in order to verify that the facility had attained substantial compliance . . . .”).

Petitioner has not met its burden to show an earlier return to compliance.  Therefore, I affirm December 30, 2020, as the date Petitioner returned to substantial compliance and the date on which the DPNA and CMP ended.

Page 69

16. The amount of the $22,320 per-day CMP imposed from October 27, 2020 through October 29, 2020, and the $435 per-day CMP from October 30, 2020 through December 29, 2020, were not challenged and are, therefore, reasonable.

CMS imposed on Petitioner a $22,320 per-day CMP for three days and a $435 per-day CMP for 61 days.  See 45 C.F.R. § 102.3 (2020); 85 Fed. Reg. 2869, 2880 (Jan. 17, 2020).

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

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

CMS argued in its brief that Petitioner did not challenge the amounts of the CMPs and, as a result, Petitioner waived that issue.  CMS Br. at 28.  Petitioner did not challenge CMS’s contention in its brief.  See P. Br.  Therefore, I uphold the CMP amounts as uncontested.

V.  Conclusion

I affirm CMS’s determination that Petitioner was not in substantial compliance with Medicare program participation requirements at 42 C.F.R. §§ 483.12(b)(1)-(3), (c)(1), (4), and 483.80(a)(1)-(2), (g)(3)(i)-(iii).

I conclude that CMS’s determination that Petitioner’s noncompliance at 42 C.F.R. § 483.80(a)(1)-(2) immediately jeopardized the health and safety of residents is not clearly erroneous.

Page 70

I affirm CMS’s imposition of a DPNA from December 5, 2020 through December 29, 2020.

I affirm CMS’s imposition of per-day CMPs in the amount of $22,320 per day from October 27, 2020 through October 29, 2020, and $435 per day from October 30, 2020 through December 29, 2020.