Ashford Hall, DAB CR6640 (2025)

DECISION

Ashford Hall (Petitioner or facility) is a skilled nursing facility (SNF) located in Irving, Texas, that participates in the Medicare program.  Based on a survey completed on November 27, 2020, the Centers for Medicare & Medicaid Services (CMS) determined that the facility was not in substantial compliance with the program participation requirements set forth in 42 C.F.R. § 483.80(a)(1)(2)(4)(e)(f), Infection Prevention and Control, Tag F880, S/S:  K1 and ultimately imposed a $8,417.00 per-day civil money penalty (CMP) for 12 days, beginning November 16, 2020 and continuing through November 27, 2020, for a total of $101,004.00.2  CMS Exhibit (Ex.) 4.  Petitioner here

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challenges those determinations and filed a timely request for hearing (RH) on February 14, 2022.

As explained below, I uphold most of the allegations used to support the finding of noncompliance.  The allegations I uphold are also sufficient to show that Petitioner immediately jeopardized the health and safety of its residents.  I also conclude that the per-day CMP amount imposed for the period of immediate jeopardy is reasonable.

I.  Background

The Social Security Act (Act) sets forth requirements for nursing facility participation in the Medicare program and authorizes the Secretary of Health and Human Services (Secretary) to promulgate regulations implementing the statutory provisions.  Act § 1819.  The Secretary's regulations are found at 42 C.F.R. Part 483.

The Secretary contracts with state survey agencies to conduct periodic surveys to determine whether skilled nursing facilities are in substantial compliance with program participation requirements.  Act § 1864(a); 42 C.F.R. § 488.20.  The regulations require that each facility be surveyed once every 12 months, and more often, if necessary, to ensure that identified deficiencies are corrected.  Act § 1819(g)(2)(A); 42 C.F.R. §§ 488.20(a), 488.308.  To be in substantial compliance, a facility's deficiencies may pose no greater risk to resident health and safety than "the potential for causing minimal harm."  42 C.F.R. § 488.301.

In this case, surveyors from the Texas Health and Human Services Commission completed a complaint/incident investigation on November 27, 2020.  CMS Exs. 1, 10.  Based on the survey findings, CMS determined that the facility was not in substantial compliance with federal requirements for nursing homes participating in the Medicare and Medicaid programs.  Specifically, CMS found that the facility did not meet the federal requirements of 42 C.F.R. § 483.80(a)(1)(2)(4)(e)(f) (Tag F880-Infection Prevention and Control, scope and severity level "K").3  Id.

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In response to the timely RFH filed by Petitioner, on February 24, 2022, Administrative Law Judge Leslie Weyn issued a Standing Prehearing Order, setting forth prehearing procedures.4  Both parties filed their prehearing exchanges, including prehearing briefs (CMS PH Br. and P. PH Br.).  With its brief, CMS submitted 23 proposed exhibits, including the written direct testimony of two witnesses.  CMS Exs. 1-23.  With its brief, Petitioner submitted 15 proposed exhibits, including the written direct testimony of one witness.  P. Exs. 1-15.

Petitioner filed Petitioner's Objections to CMS' Exhibits on June 29, 2022.  It objected to CMS proposed Exhibit 1 on the basis that it contained inadmissible hearsay and was presumably written in accordance with the Principles of Documentation.  It objected to CMS proposed Exhibits 10 and 22 on the basis that they contained inadmissible hearsay.  Petitioner objected to CMS proposed Exhibit 23, the Declaration of Daniel J. McElroy, on the basis that he had no personal knowledge of the alleged violations.  Petitioner also objected to CMS proposed Exhibit 13 on the basis that this version of the guidance was not applicable to the relevant time period at issue in this case.  On the same date, Petitioner filed a request to cross-examine one of the witnesses identified by CMS, Jennifer E. Andrus.

On February 16, 2024, I held a prehearing conference in this matter.  The parties stipulated that the issues before me are whether Petitioner was in substantial compliance with the provisions of 42 C.F.R. § 483.80(a) (Tag F880); if not, whether CMS' determination that the noncompliance posed immediate jeopardy to the facility's residents was clearly erroneous; and if Petitioner was not in substantial compliance, whether the CMP was reasonable.  Order Summarizing Pre-Hearing Conference at 1-2 (Mar. 18, 2024).

At the prehearing conference, I overruled Petitioner's objections to CMS proposed Exhibit 1 on the basis that the surveyor's statements were relevant and material and Petitioner has the opportunity to cross-examine that witness.  Petitioner withdrew its objections to CMS proposed Exhibits 10 and 22 with the provision that it would have the opportunity to cross-examine that witness at the hearing.  I overruled Petitioner's objection to CMS proposed Exhibit 13 because the relevant guidance was the same in both that exhibit and Petitioner Exhibit 4.  Finally, CMS withdrew CMS proposed Exhibit 23 so the objection to that exhibit by Petitioner was rendered moot.  Petitioner confirmed at the prehearing conference that it intended to cross-examine one of CMS' proposed witnesses, Jennifer E. Andrus.  CMS indicated it did not intend to cross-examine Petitioner's proposed witness.

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On August 30, 2024, a hearing was held at which Petitioner cross-examined CMS' witness, Jennifer E. Andrus.  I also admitted CMS Exhibits 1-225 and Petitioner Exhibits 1-15 into the record.  Transcript (Tr.) at 7.  Both parties submitted post-hearing briefs (CMS PO Br. and P. PO Br.).  The record was then closed on January 13, 2025.

II.  Issues

(1) Whether Petitioner was in substantial compliance with the Medicare program participation requirements found at 42 C.F.R. § 483.80(a) (Tag F880);

(2) If Petitioner was not in substantial compliance, whether CMS' determination that the noncompliance posed immediate jeopardy to the facility's residents was clearly erroneous; and

(3) If Petitioner was not in substantial compliance, whether the civil money penalty imposed is reasonable.

III.  Discussion6

A.  The facility was not in substantial compliance with 42 C.F.R. § 483.80(a)(1)(2)(4).

Section 1819(d)(3) of the Act mandates that a skilled nursing facility "must (A) establish and maintain an infection control program designed to provide a safe, sanitary, and comfortable environment in which residents reside and to help prevent the development and transmission of disease and infection, and (B) be designed, constructed, equipped, and maintained in a manner to protect the health and safety of residents, personnel, and the general public."

Consistent with section 1819(d)(3), 42 C.F.R. § 483.80(a) requires the facility to "establish and maintain an infection prevention and control program designed to provide a safe, sanitary, and comfortable environment and to help prevent the development and transmission of communicable diseases and infections."

The program must include:

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

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

1. A system of surveillance designed to identify possible communicable diseases or infections before they can spread to other persons in the facility;
2. When and to whom possible incidents of communicable disease or infections should be reported;
3. Standard and transmission-based precautions to be followed to prevent spread of infections;
4. When and how isolation should be used for a resident, including but not limited to:
   1. The type and duration of the isolation, depending upon the infectious agent or organism involved, and
   2. A requirement that the isolation should be the least restrictive possible for the resident under the circumstances.
5. The circumstances under which the facility must prohibit employees with a communicable disease or infected skin lesions from direct contact with residents or their food, if direct contact will transmit the disease; and
6. The hand hygiene procedures to be followed by staff involved in direct resident contact.

* * *

4. A system for recording incidents identified under the facility's IPCP [infection prevention and control program] and the corrective actions to be taken by the facility.

42 C.F.R. § 483.80(a)(1)(2)(4).

The evidence establishes that Petitioner did adopt an infection control program for COVID-19 that included rigorous testing, monitoring, and quarantine provisions to ensure that COVID-19 infections did not spread to its residents and staff.  With one exception, discussed below, CMS does not challenge the specifics of that policy, nor does CMS allege that Petitioner's policy failed to comport with accepted national standards for protection against COVID-19 infection.  Instead, CMS alleges that the facility ignored its

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own infection and control policies, as well as guidance from the Centers for Disease Control and Prevention (CDC) by failing to:

• quarantine residents that tested positive for COVID-19;
• separate residents who were COVID-19 positive, negative, and presumed positive or unknown;
• monitor residents for signs and symptoms of COVID-19 and document findings in the residents' medical records;
• ensure staff provided negative COVID-19 test results prior to working at the facility or caring for residents; and
• ensure a resident was transported to an appointment either by (1) designated facility transport staff or (2) an "essential caregiver" who had been trained by the facility on infection control, and produced evidence of a current negative COVID-19 test.

CMS PH Br. at 1.  Petitioner disputes these allegations.  RH at 3.  Each alleged violation is considered separately.

Failure to Quarantine and Separate

The facility did have a policy governing placement of residents who had tested positive for COVID-19, entitled Emergency Preparedness COVID-19 Program and Plans.  CMS Ex. 12.  That policy required the facility to establish a Separation-Quarantine Zone for increased separation of residents suspected of, presumed to be, or who had tested positive for COVID-19.  Id. at 10.  The policy designated the end of station 200 as the Separation-Quarantine zone.7  Id.  The policy further required the facility to place a resident who exhibited symptoms of an infectious disease in an isolation room and notify local public health authorities.  Id. at 6.

Similar policy guidance was contained in a document entitled COVID-19 Response for Nursing Facilities version 3.4, 8/12/20, provided by the Texas Health and Human Services Commission.  CMS Ex. 13.  That policy statement indicated that a facility should create an isolation wing/unit that provided meaningful separation between COVID-19 positive residents and the space where the facility cared for residents who were COVID-19 negative or untested and asymptomatic.  Id. at 26.  That same directive provided that "[o]nce a case of COVID-19 is identified in the facility, immediate action must be taken to isolate the resident who is positive for COVID-19 away from other residents."  Id. at 37.

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Resident # 2 (R2)

There is no dispute that R2 tested positive for COVID-19 on Friday, November 20, 2020.  CMS Ex. 10 at 22.  On that same day, he was appropriately transferred to the 200 Hall unit, which was designated as the COVID-19 isolation unit.  Id. at 21.  In an interview with the surveyor, Licensed Vocational Nurse (LVN) A reported she cared for R2 in the isolation unit on November 20, 2020 and he was the only resident there.  CMS Ex. 22 at 14.  She further indicated when she worked again on November 23, 2020, R2 was back in his original room in the 100 Hall and she then helped move him back again to the COVID-19 isolation unit.  CMS Ex. 10 at 38, 21.  The movement of R2 from the COVID-19 isolation unit back to his original room, where he remained until November 23, 2020, was confirmed by the Director of Nursing (DON).  CMS Ex. 10 at 40.

CMS alleges that this was a violation of the facility's own policy because it moved an infected resident back to a Hall of non-infected residents or residents with unknown COVID-19 status, thereby creating the risk of infecting them.  CMS PO Br. at 5-6.

Petitioner acknowledges that, in fact, R2, after being placed in the COVID-19 isolation unit on November 20, 2020, was moved back to his original room on the 100 Hall.  It asserts that this was done because it was "difficult to closely monitor Resident # 2 while he was on another wing alone" and when he was back in his room on the 100 Hall, he "was alone in his room with the door closed pending instruction from the DCHHS."  P. PO Br. at 9 n.1.

In considering the question of whether moving an infected resident from the COVID-19 isolation ward, where he was appropriately placed, back to a ward with residents of unknown COVID-19 or asymptomatic status, I have considered both the facility's own policy and the policy entitled COVID-19 Response for Nursing Facilities version 3.4, 8/12/20, provided by the Texas Health and Human Services Commission.  Neither policy gives any indication that it would be acceptable to move a resident out of a COVID-19 isolation zone once they have tested positive for COVID-19.  The reason behind these policies is obvious—to avoid infecting other residents.  While the Petitioner cites both workload reasons and a need to await instructions from DCHHS, its own policy required it to first place a resident who exhibited symptoms of an infectious disease in an isolation room and then notify local public health authorities.  CMS Ex. 12 at 6.

The problem here is that not only is a facility required by regulation to establish an infection control policy, it must then follow the policy that it established.  The Departmental Appeals Board (Board) has held that section 483.658 requires a SNF to do more than merely adopt such a program as its internal policy; the regulation also requires

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the SNF to implement the program's prescribed precautions.  Heritage House of Marshall Health & Rehab. Ctr., DAB No. 2566 at 12 (2014) (holding that section 483.65 "can only reasonably be interpreted as requiring not just that an infection control policy exist, but also that the policy be followed"); see also The Windsor House, DAB No. 1942 at 60 (2004) (stating that section 483.65 "makes clear that it is not enough simply to have an infection control program, but the facility must also follow the precautions established in that program"); Park Manor Nursing Home, DAB No. 2005 at 60 (2005) (stating that section 483.65 "can reasonably be read as requiring the facility to implement an effective infection control program in [its] daily interaction with residents").  So, Petitioner cannot establish an infection control policy for isolating COVID-19 residents then subsequently decide that such a policy did not have to be implemented for R2 because of workload issues.  The workload argument is also unpersuasive because another part of the facility's policy specifically required the facility to plan for staffing shortages, which it did not do.  CMS Ex. 12 at 12 (policy stating "[i]dentify the initial and potential minimum staffing necessary if/when worst case scenario occurs").  By moving R2 from the COVID-19 isolation unit back to the 100 Hall, the facility exposed non-infected residents on that Hall to a COVID-19 positive resident.  As such, the facility was not in compliance with the provisions of 42 C.F.R. § 483.80(a) by failing to quarantine or otherwise isolate a COVID-19 positive resident.

Residents # 3, # 4, # 5, and # 7 (R3, R4, R5, and R7)

There is no dispute that R3, R4, R5, and R7 tested positive for COVID-19 on November 22, 2020, based upon a rapid test.  CMS Ex. 10 at 11; P. Ex. 1 at 3.  There is also no dispute that these residents remained in the 100 Hall9 until November 23, 2020, when they were moved to the COVID-19 isolation unit in the 200 Hall.  CMS Ex. 10 at 41; CMS Ex. 22 at 16.

CMS alleges that the failure to immediately isolate or quarantine R3, R4, R5, and R7 after they tested positive for COVID-19 was a violation of the facility's own policy.  CMS PO Br. at 6.  Petitioner disputes that it failed to quarantine the residents after they tested positive for COVID-19.  It asserts that R3, R4, R5, and R7 tested positive on November 22, 2020 and were moved to the COVID-19 positive isolation hall on November 23, 2020.  P. PH Br. at 6.  Petitioner argues that these four residents could not be moved immediately because it took time "to determine where to move them and then physically move them and their belongings."  Id.  In addition, it alleges that "because point of care testing was not as reliable as the lab tests, the Dallas County Health and Human Services (DCHHS) contact told the Administrator to wait until the positive tests were confirmed by a lab before moving the residents to the positive (hot) wing."  Id.

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In her Declaration, Brenda Guevara, the facility administrator, stated that, after the above residents tested positive for COVID-19 on November 22, 2020, she called the Dallas County Health and Human Services and asked for assistance.  She stated that Dallas County told her to wait on the lab tests and ensure the residents were still in their own rooms by themselves with doors closed, signs posted, and PPE available.  Ms. Guevara stated that cohorting could not be done immediately because there was a lot of planning to be done and they had staffing challenges so they could not move residents if there was no one to take care of them 24 hours a day.10  P. Ex. 1 at 3.

In its post-hearing brief, Petitioner asserted that the facility properly and timely cohorted R3, R4, R5, and R7 within 24 hours of testing positive and the delay was due to the local health authority's instructions not to move these residents until the lab tests came back.  P. PO Br. at 10.  Petitioner argued that, "[d]uring this short period, Residents . . . # 3, # 4, # 5, and # 7 remained in their rooms with their doors shut and full PPE was in use by the staff.  This evidence shows that Residents . . . # 3, # 4, # 5, and # 7 were timely and appropriately cohorted in accordance with facility policy, CMS and SA guidance and local health authority directive."  Id.

There is no dispute that the facility moved R3, R4, R5, and R7 within 24 hours of them testing positive.  Tr. at 55.  However, the facility's policy provided that when it was notified of a positive test, the facility should relocate the resident to the Isolation Unit/Station 200 and obtain an order from a Physician or Nurse Practitioner for new orders.  CMS Ex. 12 at 24.  That policy further indicated that it should place a resident who exhibits symptoms of the infectious disease in an isolation room and notify local public health authorities.  Id. at 6.  Similarly, the Texas Health and Human Services Commission's COVID-19 Response for Nursing Facilities requires the facility to take "immediate action" to isolate the COVID-19 positive resident.  CMS Ex. 13 at 37.  Neither policy requires the facility to wait for permission from the local health authority before moving COVID-19 positive residents or to even notify the local health authority before moving COVID-19 residents to the isolation unit.11  To the contrary, the facility's own policy stated it should place a resident who exhibits symptoms of the infectious disease in an isolation room and (then) notify local health authorities.  CMS Ex. 12 at 6.

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Attachment 3:  Interim Guidance for Prevention, Management, and Reporting of COVID-19 Outbreaks in LTC Facilities provided that "[o]nce a case of COVID-19 is identified in the facility, immediate action must be taken to isolate the resident who is positive for COVID-19 away from other residents."  CMS Ex. 20 at 6 (emphasis added).

Moreover, neither the facility policy nor any CMS guidance requires that a particular type of test was necessary before a resident could be determined to be positive for COVID-19.  To the contrary, facility policy, which is consistent with Interim Final Rule CMS-3401-IFC, effective August 26, 2020, provides that facilities can meet testing requirements through the use of rapid point-of-care (POC) diagnostic testing," which was defined as "diagnostic testing that is performed at or near the site of resident care."  CMS Ex. 15 at 3; CMS Ex. 11 at 7.  Thus, there were no regulatory or policy provisions that required testing beyond that conducted in this case before concluding a resident was COVID-19 positive, necessitating a move to the isolation unit.

Finally, Petitioner argues that R3, R4, R5, and R7 were all moved to the isolation unit within 24 hours of them testing positive and before that move, they stayed in their rooms with the doors closed, and staff wore PPE while caring for them.  P. PO Br. at 10.  Such an argument ignores the fact that these COVID-19 residents remained on a floor with residents who were asymptomatic or status-unknown, without the dedicated staff, restricted access, and the other provisions required by the facility's own policy for a quarantine zone, thereby increasing the risk of transmission to unaffected residents for 24 hours.  CMS Ex. 12 at 10-15.  Increasing the risk even more was the fact that the 100 Hall was a secured unit and residents were reported to come and go as a result of cognition issues and the related difficulty in controlling their movements.  CMS Ex. 10 at 39.  The administrator herself acknowledged that there were several residents who wandered, an observation also made by the surveyor, who observed several residents wandering on the 100 Hall and needing redirection on November 25, 2020.  P. Ex. 1 at 3; CMS Ex. 10 at 48.  While the surveyor did not testify that she observed R3, R4, R5, or R7 out of their rooms, this does not negate the fact that the unaffected or status-unknown residents wandered around the unit where COVID-19 positive residents were housed.  Tr. at 50.  The failure to take "immediate action" by moving COVID-19 positive residents into the COVID-19 isolation unit in the 200 Hall exposed unaffected or status-unknown residents to COVID-19 for 24 hours.  As such, the facility was not in compliance with the provisions of 42 C.F.R. § 483.80(a) by failing to quarantine COVID-19 positive residents in accordance with its own policies and state guidance.

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Failure to Monitor

CDC's policy on monitoring of residents for COVID-19 was set forth in a document entitled Preparing for COVID-19 in Nursing Homes.  In that document, the CDC directed nursing facilities to both:

• Ask residents to report if they feel feverish or have symptoms consistent with COVID-19, and
• Actively monitor all residents upon admission and at least daily for fever and symptoms consistent with COVID-19.  Ideally, include an assessment of oxygen saturation via pulse oximetry.

CMS Ex. 19 at 6 (emphasis added).  That document further provided that older adults with COVID-19 may not show common symptoms, such as fever or respiratory symptoms.  Less common symptoms were identified as including new or worsening malaise, headache, or new dizziness, nausea, vomiting, diarrhea, or loss of taste or smell.  CMS Ex. 19 at 6.

Nearly identical guidance is contained in Attachment 3:  Interim Guidance for Prevention, Management, and Reporting of COVID-19 Outbreaks in LTC Facilities.  CMS Ex. 20.  That policy statement also required nursing facilities to ask residents to report if they felt feverish or had symptoms of respiratory infection and COVID-19 and to monitor all residents at least three times daily for fever and respiratory symptoms, including shortness of breath, new or change in cough, sore throat, and oxygen saturation.  Id. at 5.  It noted that people with symptoms of fevers 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, or diarrhea may have COVID-19.  Id. at 5-6.

The initial question here is whether the facility had a policy on monitoring residents for symptoms of COVID-19.  Petitioner asserts that it did have a policy on monitoring, which was set forth in CMS Exhibit 11 at 2 as "actively screen residents daily for fever and respiratory symptoms."  P. PO Br. at 10.  It argues that its monitoring of the residents at issue was in compliance with its policies and procedures and CDC guidance.  Id.

It must be first noted that this policy does not encompass the full complement of COVID‑19 symptoms that are required to be monitored.  As indicated above, the CDC policy required monitoring of fever and symptoms consistent with COVID-19, which included numerous other symptoms, including new or worsening malaise, headache, or new dizziness, nausea, vomiting, diarrhea, and loss of taste or smell.  CMS Ex. 19 at 5-6.  Based on this symptom list, it is clear that the facility's policy own monitoring was not consistent with the federal policies or guidance.  So, while Petitioner could argue it was

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following its own policy on monitoring, I cannot find that this policy was in compliance with the CDC policy, cited above.

The question then becomes whether the facility was compliant with the federal policy on monitoring.  CMS asserts that the facility failed to fully and completely monitor Residents 2, 3, 4, 5, 6, 7, 8, and 9.  It argues that Petitioner's charting tool required monitoring of Pulse, Respirations, Blood Pressure, Pain Scale, Oxygen Saturation, Temperature, and Results.  CMS PO Br. at 8.  CMS alleges that the facility did not monitor these findings for the above residents during all three shifts and did not record findings for all these categories.12  Id. at 8-10.  It particularly noted the facility failed to consistently record these residents' pain scales.  Id.  Petitioner argues that, in fact, the above residents were monitored for signs and symptoms of COVID-19 on the days in question and there was no requirement to monitor residents for "pain."13  P. PO Br. at 7.

In resolving this question, I would agree with Petitioner that there is no requirement to specifically monitor for "pain."  However, the facility was directed to monitor residents for "fever and symptoms consistent with COVID-19," which was defined as including new or worsening malaise, headache, and muscle or body aches.  CMS Ex. 19 at 6; CMS Ex. 20 at 4-5 (emphasis added).  One could quibble about whether aches or malaise are the same as or a euphemism for pain.  However, even assuming they were distinctively different concepts, the fact remains that the facility did not then specifically monitor for aches or malaise, which were listed possible symptoms of COVID-19.  While the policy from CDC does not require a pain scale, it does require consideration of sore throat and muscle or body aches as possible COVID-19 symptoms, so there should have been some indication in the facility's records that this was assessed, even if it wasn't through a formal pain scale.  As a result, I find that the facility was not in compliance with the provisions of 42 C.F.R. § 483.80(a) by failing to monitor its residents for symptoms of COVID-19, in accordance with CMS policies and guidance.

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Failure to Test

In the Statement of Deficiencies, the surveyor alleged that the facility was out of compliance with 42 C.F.R. § 483.80(a) because it failed to ensure that a floor tech was tested for COVID-19 twice a week, based on the local county positive rate, and allowed him to continue to work after his refusal to test a second time.  CMS Ex. 1 at 10; CMS PH Br. at 14.  This allegation was based on the statement from the surveyor that Floor Tech D had only one COVID-19 test completed for the week of November 15, 2020 through November 22, 2020 and he had refused to be tested on November 20, 2020.  CMS Ex. 22 at 22.  CMS cited the facility's policy of requiring testing of employees twice a week if the county positivity rate was greater than 10 percent, which was the case at the time of the survey.  CMS Ex. 11 at 9.

At the hearing, the surveyor acknowledged that Floor Tech D was tested on November 18, 2020 and was tested again on November 24, 2020.  Tr. at 69-70.  Petitioner argues that the evidence establishes that the employee was tested twice within a week and there is no facility policy, regulatory requirement, or guidance that required the facility to test its employees on certain days.  Petitioner asserts that, as a result, there was no violation of any policy, regulation, or guidance on the part of the facility for failure to appropriately test its employees.  P. PO Br. at 12.  CMS did not provide any argument to the contrary in its post-hearing brief and, in fact, did not address this allegation at all.14  Given this, I find that this noncompliance allegation is not supported by the record.

Failure to Ensure Hospice Staff were Covid-19 Negative

CMS asserts that the facility failed to ensure hospice staff provided a negative COVID-19 test conducted within the last 14 days prior to allowing them to enter and care for residents.  CMS Ex. 1 at 10.  CMS cites as support for this allegation statements by the surveyor.  Ms. Andrus indicated that she reviewed a Seasons Hospice and Palliative Care report, which showed the following hospice staff visited Resident # 8 (R8) in November 2020:

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Shantae Page-aide
DP???
K Henry RN
Ron Scott-Chaplain

CMS Ex. 10 at 47.

In her notes, Ms. Andrus stated that the hospice test results provided to her by the Front Desk Receptionist, who tracked the results, did not include any COVID-19 test results for Shantae Page, DP, or Ron Scott.  CMS Ex. 10 at 48.  In her Declaration, Ms. Andrus somewhat inconsistently stated that the COVID-19 test results provided by the Front Desk Receptionist showed the hospice aide and chaplain for R8 did not have any evidence of a COVID-19 test, but she did not mention DP in that statement.  CMS Ex. 22 at 25.

There is no dispute that both facility policy and CMS guidance required testing of hospice workers before entering the facility.  CMS guidance provided that health care workers who were not employees of the facility but who provided direct care to the facility's residents, such as hospice workers, must be permitted to come into the facility as long as they are not subject to a work exclusion due to an exposure to COVID-19 or show signs or symptoms of COVID-19 after being screened.  CMS Ex. 14 at 6.  A CMS Interim Final Rule, CMS-3401-IFC, dated 8/26/20, revised 4/27/21,15 required facility staff, which included employees, consultants, contractors, volunteers, and caregivers, to be tested during an outbreak and re-tested every 3 to 7 days until testing identified no new cases of COVID-19 infection among staff or residents for a period of at least 14 days.  CMS Ex. 15 at 3-4.  The facility had a nearly identical policy.  CMS Ex. 11 at 8.  The problem here is that there is no persuasive or reliable evidence to establish that the facility allowed untested hospice workers to enter the facility and care for R8.

The Board has long held that CMS has the burden of coming forward with evidence related to disputed findings that is sufficient (together with any undisputed findings and relevant legal authority) to establish a prima facie case of noncompliance with a regulatory requirement.  It is only after CMS makes this prima facie showing that the SNF must then assume its ultimate burden of persuasion by showing, by a preponderance of the evidence, on the record as a whole, that it was in substantial compliance during the relevant period.  Hillman Rehab. Ctr., DAB No. 1611 (1997), aff'd, Hillman Rehab. Ctr. v. U.S. Dep't of Health & Human Servs., No. 98-3789 (GEB) (D. N.J. May 13, 1999); Batavia Nursing & Convalescent Inn, DAB No. 1911 (2004), aff'd, Batavia Nursing & Convalescent Ctr. v. Thompson, 143 F. App'x 664 (6th Cir. 2005); Guardian, DAB No.

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1943 (2004); Fairfax Nursing Home, Inc., DAB No. 1794 (2001), aff'd, Fairfax Nursing Home, Inc. v. U.S. Dep't of Health & Human Servs., 300 F.3d 835 (7th Cir. 2002), cert. denied, 2003 WL 98478 (Jan. 13, 2003).

In this case, CMS has not made a prima facie showing that hospice workers were allowed to enter the facility and care for R8 or any other resident without providing evidence of a timely negative COVID-19 test.

To begin, the Seasons Hospice document referenced by Ms. Andrus in her notes at CMS Ex. 10 at 47 as demonstrating which hospice workers entered the facility to provide care to R8 is not included in the record.  There were no facility records submitted to document the hospice workers who may have entered the facility during November 2020 to work with R8.  In her testimony, Ms. Andrus acknowledged that she was not aware of any sign-in sheets or any other documentation of which hospice workers entered the facility.  Tr. 72-73.  Moreover, her statements are inconsistent even with respect to how many hospice workers allegedly entered the facility and failed to provide COVID-19 tests.  In her Declaration, Ms. Andrus indicated there were two hospice workers, a chaplain, and an aide, who entered the facility but failed to provide test results.  CMS Ex. 22 at 25.  Yet, in her notes she indicated that, based on the receptionist's statements, there were three hospice workers who entered the facility but failed to provide a negative COVID-19 test:  Shantae Page, DP, and Ron Scott.

Moreover, Petitioner did provide negative COVID-19 test results for a number of individuals who are presumed to be hospice workers.  P. Ex. 15.  Concededly, those results do not contain any negative test results for DP16 or Ron Scott.  However, as noted above, we have no documentation that DP or Ron Scott actually entered the facility in November 2020.  Contrary to the statements from Ms. Andrus, there is, in fact, a negative COVID-19 test for a Shante Page17 on November 13, 2020.  Id. at 5.  Since there is no

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documentation as to whether Shante Page entered the facility on any other dates when they did not provide evidence of a negative COVID-19 test, CMS fails to establish that this particular hospice worker entered the facility without providing a negative COVID‑19 test.

The sole evidence that certain hospice workers entered the facility without providing negative COVID-19 tests were the statements from the receptionist, as reported by the surveyor.  In view of the fact that this evidence did not include complete names, was inconsistent as to the number of hospice workers involved, and was not accompanied by any corroborating documentation, the statements from the receptionist and Ms. Andrus on this issue are given no weight.  Accordingly, I find that this noncompliance allegation is not supported by the record.

Failure to Ensure "Essential Caregiver" Transport

The essential facts related to this allegation are not in dispute.  On November 16, 2020, Resident # 1's (R1) father transported him to an off-site doctor's appointment and visited a fast-food restaurant during this transport.18  Upon his return, R1 was placed back in his room with his roommate in a non-isolation, "cold zone."  CMS Ex. 22 at 7.  Those two residents subsequently tested positive for COVID-19.  Id.

CMS asserts that the facility allowed R1 to be transported to a doctor's appointment by his father, who was not an essential caregiver, had not been trained by the facility on infection control and PPE protocol, and had not provided the facility with evidence of a COVID negative test within the prior 14 days, in violation of the facility's own policy.  CMS PO Br. at 18; CMS Ex. 1 at 9.  It cites as support for this conclusion the facility's policy on "essential caregivers."  That policy, which is contained in the policy statement entitled "Visitation, Infection Control During," defines "Essential Caregiver" as "a personal, indoor visit between a resident and a designated essential caregiver . . . who is at least 18 years old and has been designated by the resident or legal representative to provide care to a resident."  CMS Ex. 21 at 2.  That policy further provides that each essential caregiver "must be trained by a facility on personal protective equipment (PPE) and infection control.  Prior to visit, caregivers must have a negative COVID-19 test result(s) performed no more than 14 days before the visit."  Id.  CMS further asserted that the facility violated its own policy by not placing R1 into the quarantine unit upon his return from the doctor's visit.  CMS PO Br. at 11.

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Petitioner argues that there was no facility policy or procedure that prohibited a resident from being transported out of the facility by a family member who did not meet the requirements of an essential caregiver.  P. PO Br. at 5.  In addition, Petitioner asserts that there was no CMS or other regulation or guidance requiring R1 to be quarantined for two weeks after the doctor's appointment.  Id. at 8.

To begin, the "essential caregiver" allegation is a red herring.  There is no regulation or policy that forbids a family member from transporting a resident to a medical appointment without being qualified as an essential caregiver.  In fact, the facility policy cited immediately below clearly anticipates a family member transporting a resident to a doctor's appointment.  So, the fact that the facility allowed R1's father, who was not qualified as an essential caregiver, to transport R1 to a doctor's appointment does not result in a conclusion that there was a violation of 42 C.F.R. § 483.80(a).  The relevant question is whether it was a violation of that section of the regulations to not quarantine R1 upon his return to the facility after the doctor's visit.

CMS points to the facility's policy contained in CMS Ex. 11 at 4, which governs outside appointments.  That section provides that a resident who is required to go to a doctor's appointment outside of the facility will be moved to the quarantine area for 14 days, if accompanied by a family member.  CMS PO Br. at 11.  Petitioner argues that this policy "was much stricter than the CMS and SA [state agency] guidance at the time," which indicated that "Residents who leave the facility for medically necessary appointment and return the same day are not considered to have unknown COVID-19 status.  These residents' COVID-19 status is the same as when they left the facility for their appointment and can return to their usual room."  P. PO Br. at 7.

Concededly, the facility's policy is much stricter than that set forth in Petitioner Exhibit 4 at 18 and CMS Exhibit 13 at 18.19  However, the fact remains that it was the facility's written policy to quarantine a resident for 14 days if that resident went to a medical appointment outside the facility accompanied by a family member.  R1 went to a doctor's appointment on November 16, 2020 and was accompanied by his father, who transported him.  CMS Ex. 22 at 7.  Upon his return, he was placed back in his room with his roommate instead of being quarantined.  Id.  The facility's actions were not in compliance with its own policy.

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As the Departmental Appeals Board has repeatedly explained, a facility's policy for implementing a regulatory requirement reflects the facility's own judgment about how best to achieve compliance.  Failing to comply with its own policies "can support a finding that the facility did not achieve compliance with the regulatory standard."  Bivins Memorial Nursing Home, DAB No. 2771 at 9 (2017); Hanover Hill Health Care Ctr., DAB No. 2507 at 6 (2013); Life Care Ctr. of Bardstown, DAB No. 2233 at 21-22 (2009) (finding that a facility's failing to comply with its own policies can constitute a deficiency).

Petitioner argues that the failure to quarantine did not result in any potential for more than minimal harm since there was no close contact with others, both R1 and his father wore masks, and there was no evidence they failed to take other precautions while in the restaurant or otherwise away from the facility.  P. PO Br. at 7-8.  These allegations do not counter the fact that R1 left the facility with a family member of unknown COVID-19 status and visited both a physician's office and a fast-food restaurant, where he used the restroom, before returning to the facility in his original, non-quarantined room.  Most telling is the fact that both R1 and his roommate subsequently tested positive for COVID-19.  CMS Ex. 10 at 17, 36, 39; CMS Ex. 22 at 7.  As a result, the record establishes that the facility was not in compliance with the provisions of 42 C.F.R. § 483.80(a) by failing to quarantine a resident who attended a doctor's appointment with a family member, in violation of its own policy.

2. CMS' determination that Petitioner's noncompliance with 42 C.F.R. § 483.80(a) posed immediate jeopardy to resident health and safety was 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' determination as to the level of a facility's noncompliance (which includes an immediate jeopardy finding) unless it is "clearly erroneous."  42 C.F.R. § 498.60(c).  The "clearly erroneous" standard imposes on facilities a heavy burden to show no immediate jeopardy, and determinations of immediate jeopardy have been sustained where CMS presented evidence "from which ‘[o]ne could reasonably conclude' that immediate jeopardy exists."  See, e.g., Barbourville Nursing Home, DAB No. 1962 at 11 (2005) (quoting Florence Park Care Ctr., DAB No. 1931 at 27-28 (2004)).  In reviewing CMS' 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 v. Price, 868 F.3d 605, 618 (7th Cir. 2017) (emphasis omitted).

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Petitioner argues that any alleged noncompliance did not result in a likelihood that serious injury, harm, impairment or death would occur to any resident and, as a result, the determination of immediate jeopardy was clearly erroneous.  P. PH Br. at 8-9; P. PO Br. at 14.

Contrary to Petitioner's arguments, the record supports a finding of immediate jeopardy.  As the CDC noted, the vulnerable nature of the nursing home population combined with the inherent risks of congregate living in a healthcare setting have required aggressive efforts to limit COVID-19 exposure and to prevent the spread of COVID-19 within nursing homes.  CMS Ex. 19 at 1.  Nursing home residents are at an especially high risk of contracting COVID-19 because they often have multiple health problems, combined with advanced age; and germs can spread very easily between people who live near each other.  CMS Ex. 19 at 1; CMS Ex. 23 at 4.  As demonstrated by the COVID-19 pandemic, a strong infection prevention and control program is critical to protect both residents and healthcare personnel.  CMS Ex. 19 at 1.

In this case, the evidence established that Petitioner failed to follow its own policies and CDC guidance to isolate and quarantine residents, which potentially exposed this vulnerable population to the COVID-19 virus.  The facility's specific failure to quarantine R1 after his doctor appointment and failure to keep a COVID-positive R2 in the isolation unit exposed other residents to COVID-19.  This level of noncompliance was "likely to cause serious injury, harm, impairment, or death to a resident."  Rosewood, 868 F.3d at 618.  Therefore, it was not clearly erroneous for CMS to determine that Petitioner's failure to fully implement several of its infection control provisions was likely to cause serious harm to its residents.

3. The $8,417.00 per‑day CMP for 12 days from November 16, 2020 through November 27, 2020 is reasonable.

CMS imposed a $8,417.00 per-day CMP for 12 days (November 16, 2020 through November 27, 2020) for a total CMP of $101,004.00.  CMS Ex. 4 at 1.  When CMS imposes a per-day CMP, an SNF may challenge the amount and duration of the CMP.

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

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The regulations leave the decision regarding the choice of remedy to CMS, and the amount of the remedy to CMS and the ALJ, requiring only that the regulatory factors at 42 C.F.R. §§ 488.438(f) and 488.404 be considered when determining the amount of a CMP within a particular range.  42 C.F.R. §§ 488.408, 488.408(g)(2), 498.3(d)(11); see also 42 C.F.R. § 488.438(e)(2) and (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).

Petitioner does not provide any evidence or argument as to the issue of the reasonableness of the CMP beyond asserting that CMS did not specifically evaluate the regulatory factors, such as history of non-compliance and Petitioner's financial situations.  P. PH Br. at 11; P. PO Br. at 15.  However, Petitioner has not presented any specific argument addressing the factors cited in 42 C.F.R. § 488.438(f)(1)-(4) and/or 42 C.F.R. § 488.404 (incorporated by reference into 42 C.F.R. § 488.438(f)(3)); the regulations for assessing the reasonableness of the CMP.  Petitioner failed to argue that any of the factors support a reduction of the CMP amount.  Because of the presumption that CMS has considered the regulatory factors in setting the amount of the CMP and that those factors support the CMP amount imposed by CMS and the absence of specific argument related to the regulatory factors, I must sustain it.  On that basis, I conclude that the CMP amount is reasonable.

IV.  Conclusion

I find that the facility was not in substantial compliance with 42 C.F.R. § 483.80(a) and that the immediate jeopardy determination was not clearly erroneous.  I further find that a per-day CMP of $8,417.00 for 12 days beginning on November 16, 2020 and continuing through November 27, 2020, for a total of $101,004.00 is reasonable.