Brooke Knoll Village, DAB CR6593 (2024)

DECISION

Brooke Knoll Village (Petitioner or “the facility”) challenges the determination by the Centers for Medicare & Medicaid Services (CMS) to impose a civil monetary penalty (CMP) of $8,830 per day beginning April 8, 2020, and continuing through and inclusive of April 11, 2020, based on the facility’s immediate-jeopardy noncompliance with Medicare participation requirements for infection prevention and control.  As explained below, I uphold CMS’s determinations.

I. Background

The Social Security Act (Act) establishes requirements for skilled nursing facility (SNF) participation in the Medicare program and authorizes the Secretary of Health and Human Services (“the Secretary”) to promulgate regulations implementing those statutory provisions.  See 42 U.S.C. § 1395i-3; 42 C.F.R. pts. 483 and 488.  To participate in the Medicare program, SNFs must maintain substantial compliance with program participation requirements.  In order to be in substantial compliance, any deficiencies may “pose no greater risk to resident health or safety than the potential for causing minimal harm.”  42 C.F.R. § 488.301.  “Noncompliance” means “any deficiency that causes a facility to not be in substantial compliance.”  Id.

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The Secretary contracts with state agencies to conduct periodic surveys to determine whether SNFs are in substantial compliance with participation requirements.  42 U.S.C. § 1395aa(a); 42 C.F.R. §§ 488.10, 488.20.  The Act and its implementing regulations require that facilities be surveyed on average every 12 months, and more often, if necessary, to ensure that identified deficiencies are corrected.  42 U.S.C. § 1395i‑3(g)(2)(A); 42 C.F.R. §§ 488.20(a), 488.308.

CMS may impose a per-day CMP for the number of days a facility is not in substantial compliance or a per-instance CMP for each instance of the SNF’s noncompliance.  42 U.S.C. § 1395i-3(h)(2)(B)(ii); 42 C.F.R. § 488.430(a).1  If CMS imposes a remedy based on a noncompliance determination, then the facility may request a hearing before an administrative law judge (ALJ) to challenge the noncompliance finding and enforcement remedy.  42 U.S.C. §§ 1320a-7a(c)(2), 1395i‑3(h)(2)(B)(ii); 42 C.F.R. §§ 488.408(g), 488.434(a)(2)(viii), 498.3(b)(13).

The state survey agency (state agency) of the Indiana State Department of Health (ISDH) visited the facility in April 2020 to investigate a complaint, and the “visit resulted in a Partially Extended Survey – Substandard Quality of Care – Immediate Jeopardy.”  CMS Ex. 1 at 1.  The state agency cited noncompliance with 42 C.F.R. § 483.80(a) (Tag F-880) at a scope and severity level of “K.”2  CMS Ex. 1 at 2.  In an imposition notice dated August 27, 2020, CMS imposed a per-day CMP of $8,830 for the facility’s immediate jeopardy noncompliance from April 8, 2020, through and inclusive of April 11, 2020.  DAB E-File Dkt. No. C-21-89, Doc. No. 1(a) at 1-2.3

Petitioner timely requested a hearing on October 23, 2020.  Consistent with my standing pre-hearing order (Pre-Hearing Order), CMS filed a pre-hearing brief, which incorporated a motion for summary judgment (CMS Br.), along with 25 proposed exhibits (CMS Exs. 1-25).  Petitioner filed a response, including a cross-motion for summary judgment (P. Br.), a response to CMS’s motion for summary judgment, and seven proposed exhibits (P. Exs. 1‑7).  Thereafter, CMS filed a combined reply brief and response to the cross-motion for summary judgment (CMS Reply).  After the parties completed the briefing

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schedule established by my standing prehearing order, Petitioner, without seeking leave,  filed an additional rebuttal and response.4

CMS submitted the written direct testimony of three witnesses (CMS Exs. 22-24), and Petitioner submitted the written testimony of four witnesses (P. Exs. 1-2, 4-6).  See Pre-Hearing Order § 11.  After initially requesting an opportunity to cross-examine the opposing parties’ witnesses, the parties jointly moved for a decision on the record.  DAB E-File Dkt. No. C-21-89, Doc. No. 18.  I grant the joint motion.  The record is closed, and this case is ready for a decision.5  See Pre-Hearing Order § 13 (“An in-person hearing to cross-examine witnesses will be necessary only if a party files admissible, written direct testimony, and the opposing party asks to cross-examine the witness(es).”).

II. Evidentiary Rulings

As previously noted, CMS proposed 25 exhibits and Petitioner proposed seven exhibits.  The regulations governing this proceeding direct that I “receive[] in evidence the testimony of witnesses and any documents that are relevant and material,” 42 C.F.R. § 498.60(b)(1), even evidence that would be “inadmissible under the rules of evidence applicable to court procedure.”  42 C.F.R. § 498.61.

Petitioner objects to certain CMS witness testimony on the basis that it is “unreliable.”  In particular, Petitioner objects to the ultimate opinion and “any corresponding direct testimony” of one of the surveyors, Ms. Creasey, who is a registered nurse.  P. Obj. at 1.  Petitioner further objects to “[a]ll opinions” contained within the declaration of CMS’s expert witness, William Schwartzman, MD.  P. Obj. at 1.

Petitioner argues that Ms. Creasey’s ultimate opinion is “unreliable” and “biased” because she “rejects” and “diminish[es]” what Petitioner characterizes as the “instruction” it received from the state agency to presume every resident was COVID-19 positive.  P. Obj. at 3-5.  Petitioner also complains that the surveyor’s testimony ignores its argument that the mandatory language contained within the infection control regulation “has been consistently interpreted as imposing a reasonableness standard.”  P. Obj. at 5-6.  Petitioner further argues that Ms. Creasey’s ultimate opinion is based on an unreliable investigation in which she purportedly failed to discover that the facility had, in fact, tried to increase its stock of personal protective equipment (PPE) using online resources established by the state health agency.  P. Obj. at 6-8 (citing P. Ex. 4 (testimony of Mr. K. Woodcock)).

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As I explained at the outset of the case in section 13 of my Pre-Hearing Order (in explaining when it is unnecessary to cross-examine a surveyor), I am not bound by the legal conclusions of state agency surveyors.  Thus, while I will make my own legal conclusions, the presence of such legal conclusions in a witness’s testimony does not render the testimony inadmissible.  Petitioner’s objections to the other portions of the surveyor’s testimony go to the weight of those statements, not their admissibility.  Petitioner essentially disagrees with the testimony, complaining that it is inconsistent with its evidence and inconsistent with its construction of the relevant regulatory language.  I overrule those objections.

Petitioner raises similar complaints regarding Dr. Schwartzman’s testimony.  According to Petitioner, Dr. Schwartzman’s testimony is unreliable because it also fails to consider (1) the state agency’s instruction to presume all residents were COVID-19 positive; (2) Petitioner’s related testimony from its Director of Nursing (DON); and (3) the regulation’s incorporated reasonableness standard.  P. Obj. at 8.  Petitioner adds that the testimony is unreliable because it relies on “conclusory allegations.”  P. Obj. at 9.

Again, Petitioner essentially objects to Dr. Schwartzman’s opinions as inconsistent with its evidence and legal arguments.  I will consider those objections as going to the weight of the opinions, not their admissibility.  I therefore overrule Petitioner’s objections to Dr. Schwartzman’s opinions in CMS Ex. 24.

Finally, Petitioner also objects to CMS Exs. 18-20, which are Informal Dispute Resolution (IDR) documents, on grounds that they are inadmissible settlement negotiations and are irrelevant.  P. Obj. at 9.  I agree with CMS that the IDR documents are not a settlement negotiation and that they are otherwise relevant to establishing underlying facts in this case.  CMS Reply at 2 n.2.  I therefore overrule Petitioner’s objections to CMS Exs. 18-20.

For its part, CMS objects to P. Ex. 7 on the basis that it consists of a legal brief and attachments.  As to the legal brief portion, CMS asserts that “arguments by counsel are not evidence,” and as to the remaining pages, CMS asserts that they are duplicative of P. Exs. 1-2.  CMS Obj. at 1.  The entire exhibit is in fact duplicative of Petitioner’s hearing request and attachments, and therefore will be excluded for that reason.

In summary, I admit CMS Exs. 1-25 and P. Exs. 1-6.

III. Issues

Whether Petitioner was in substantial compliance with the Medicare program participation requirement at 42 C.F.R. § 483.80(a);

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If Petitioner was not in substantial compliance, whether the immediate jeopardy determination was clearly erroneous; and

If Petitioner was not in substantial compliance, whether a per-day CMP of $8,830 is a reasonable enforcement remedy.

IV. Discussion6

1. Dating back to October 2015, Petitioner had an Infection Control Manual policy in effect in which it acknowledged that “Isolation procedures (i.e., Transmission-Based Precautions) are designed to protect other residents, personnel and visitors from the spread of confirmed or suspected infection or contagious disease” and that “Residents should be isolated with Transmission-Based Precautions instituted whenever there is increased risk of spreading infection.”
2. At the outset of the COVID-19 pandemic in March 2020, Petitioner updated its Infection Control Manual with a “Pandemic COVID-19 Emergency Preparedness Plan” in which it re-affirmed the necessity of transmission-based precautions, explaining that it “has infection control policies within the Infection Control Manual . . . that outline the recommended Transmission Based Precautions that should be used when caring for residents with respiratory infection.”  In addition to stating that its COVID-19 response coordinator/administrator would monitor federal and state public health advisories and provide updates of specific information released that affects facility practices, Petitioner’s March 2020 policy stated it “shall follow any [ISDH] recommendations, State orders executed by the Governor, or Federal mandates for limiting symptomatic and exposed residents to their room, halting group activities and communal dining, and closing units or the entire facility to new admissions.”  The policy directed transmission-based precautions that included the isolation of residents with COVID-19 or suspected COVID-19.  The policy defined the “symptoms of respiratory infection,” for purposes of identifying, screening, and managing residents with COVID-19 or suspected COVID-19, to include “cough, fever, and sore throat.”
3. On March 29, 2020, ISDH issued updated COVID-19 infection control guidance for long-term care facilities that included directing facilities to follow CDC guidance, isolate residents with COVID-19 or

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3. suspected COVID-19, and to implement infection control measures for residents with COVID-19 or suspected COVID-19, to include droplet precautions, frequent hand hygiene, and cohorting staff and residents.
4. Between March 28 and April 3, 2020, a state agency “strike team” tested multiple facility residents for COVID-19 and at least six residents tested positive for COVID-19.
5. The facility reports that following a conversation with the state agency on April 3, 2020, it began implementing transmission-based precautions for every resident in the facility.
6. The facility reports it discontinued facility-wide transmission-based precautions after four days, on April 7, 2020, out of a concern for depletion of its PPE stock.
7. The facility reports that because of the limited COVID-19 testing resources available at the time it discontinued facility-wide transmission-based precautions, it devised and implemented a testing protocol of laboratory tests and imaging in order to identify residents who may have COVID-19.  Under the protocol, and depending on a resident’s symptoms and/or complaints, a facility nurse would order testing to help the facility determine the underlying cause of those symptoms.  The protocol also defined the circumstances for initiating transmission-based precautions for residents.  The testing protocol did not test for COVID-19.
8. The facility’s protocol departed from the facility’s policies that had been informed by CDC and state guidance, in that the protocol delayed the implementation of transmission-based precautions for certain residents who may have had symptoms of COVID-19; the protocol also failed to address precautions for asymptomatic residents who had been in close contact with a confirmed COVID-19 positive patient.
9. During the course of a survey on April 9, 2020, a surveyor observed that transmission-based precautions were not in place for Resident B, Resident C, and Resident D because all three residents were in and around their rooms with doors open and there was no signage on their respective doors indicating any appropriate precautions.

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10. Petitioner’s policies, which had been informed by CDC and state guidance, required the facility to implement transmission-based precautions for Resident B because she had been in close contact with a roommate who was presumed to have COVID-19, for Resident D because she exhibited signs or symptoms of COVID-19, and for Resident C because she both had been in close contact with a roommate who was presumed to have COVID-19 and she herself had exhibited signs or symptoms of COVID-19.
11. Regardless of whether the facility’s stock of PPE was depleted, the facility could have implemented other transmission-based precautions, including isolating suspected COVID-19 residents in their rooms with the door closed and placing a sign on the resident’s door indicating the appropriate precautions.  However, the facility delayed implementing such precautions until after obtaining the results of the testing it obtained pursuant to its April 2020 protocol.

A skilled nursing facility is required to establish and maintain an infection prevention and control program.

Pursuant to section 1819(d)(3) of the Act, Sanitary and Infection Control and Physical Environment, 42 U.S.C. § 1395i-3(d)(3), a skilled nursing facility must establish and maintain an infection prevention and control program to provide “a safe, sanitary, and comfortable environment in which residents reside and to help prevent the development and transmission of disease and infection.”  In furtherance of this statutory requirement, 42 C.F.R. § 483.80(a)(1), (2), (4); (e), (f) (Tag F-880) requires skilled nursing facilities to establish and maintain an infection prevention and control program that is designed to provide a safe, sanitary, and comfortable environment that helps to prevent the development and transmission of communicable diseases and infections.

As relevant for purposes of this decision, a facility’s infection prevention and control program must include “[a] system for preventing, identifying, reporting, investigating, and controlling infections and communicable diseases for all residents, staff, volunteers, visitors, and other individuals providing services . . . based upon the facility assessment . . . and . . . national standards.”  42 C.F.R. § 483.80(a)(1).  Additionally, a facility must have written standards, policies, and procedures for its infection prevention and control program that include “[s]tandard and transmission-based precautions to be followed to prevent spread of infections.”  42 C.F.R. § 483.80(a)(2)(iii).  The Departmental Appeals Board (DAB) has explained that the regulation, as currently stated in 42 C.F.R. § 483.80(a)(2)7, “can only reasonably be interpreted as requiring not just that an infection

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control policy exist, but also that the policy be followed.”  Heritage House of Marshall Health & Rehab. Ctr., DAB No. 2566 at 12 (2014).

Policies in Petitioner’s Infection Control Manual

Petitioner has a longstanding policy in its Infection Control Manual dating back to October 2015 that provided “Isolation (Transmission-Based Precautions) Guidelines.”  CMS Ex. 12.  The policy states that “[i]solation procedures (i.e., Transmission-Based Precautions) are designed to protect other residents, personnel and visitors from the spread of confirmed or suspected infection or contagious disease.”  CMS Ex. 12 at 1.  The policy states that “[a]lthough Standard Precautions should aways be in effect, certain procedures/precautions may be instituted to supplement Standard Precautions in residents with known or suspected colonization of infection of highly transmissible or epidemiologically significant pathogens.”  CMS Ex. 12 at 1.  The policy states that “[r]esidents should be isolated with Transmission-Based Precautions instituted whenever there is increased risk of spreading infection.”  CMS Ex. 12 at 1.  The policy further states that “[t]he health care team and visitors should be instructed on the importance and necessity of maintaining precautions before entering the resident’s room.”  CMS Ex. 12 at 1.

In March 2020, at the outset of the COVID-19 pandemic, the facility implemented a “Pandemic COVID-19 Emergency Preparedness Plan” as part of its Infection Control Manual that repeatedly referenced Centers for Disease Control and Prevention (CDC) guidance regarding infection control measures intended to reduce the spread of COVID-19.  CMS Ex. 16.  The policy explains that “[t]he facility has infection control policies within the Infection Control Manual (See Section III – Isolation Precautions) that outlined the recommended Transmission Based Precautions that should be used when caring for residents with respiratory infection.”  CMS Ex. 16 at 2.  The policy states that Petitioner’s COVID-19 Response Coordinator “will be assigned the responsibility for monitoring public health advisories (federal and state) and updating the COVID-19 Response Team/Department Heads of specific information released which would affect facility practices.”  CMS Ex. 16 at 1.

With respect to the “identification and management of ill residents,” Petitioner’s March 2020 policy states that the “facility has a process to identify/screen and manage residents with symptoms of respiratory infection (e.g., cough, fever, sore throat) upon admission and daily during their stay in the facility, which includes implementation of appropriate Transmission-Based Precautions, when indicated.”  CMS Ex. 16 at 3.  The policy further requires the facility to “follow any ISDH recommendations, State orders executed by the Governor, or Federal mandates for limiting symptomatic and exposed residents to their room, halting group activities and communal dining, and closing units or the entire facility to new admissions.”  CMS Ex. 16 at 3.

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The facility’s policy includes the following transmission-based precautions:

• Residents with known or suspected COVID-19 shall be cared for in a single-person (private) room with the door closed, if a single room is available (CMS Ex. 16 at 9);
• Residents with close contact with a confirmed COVID-19 resident shall be isolated and follow 14-day self-monitoring guidelines outlined by CDC.  If they develop symptoms and are confirmed or suspected to have COVID-19, they shall remain in isolation until at least 14 days after illness onset or 72 hours after resolution of fever, without use of antipyretic medication and improvement in symptoms (e.g., cough), whichever is longer (CMS Ex. 16 at 9);
• Necessary PPE shall be available in resident rooms and in other areas where resident care is provided (CMS Ex. 16 at 3); and
• Signs shall be posted immediately outside of resident rooms indicating appropriate Transmission Based Precautions, as applicable, and required PPE (CMS Ex. 16 at 2).

ISDH’s March 2020 guidance

On March 29, 2020, ISDH issued updated infection control guidance for long-term care facilities.  The guidance for facilities with “a confirmed or suspected case of COVID-19” include “guiding principles” that included the following:

• Placement of resident in contact-droplet precautions with proper PPE, including gown, glove, mask with face shield or eye protection;
• Proper donning and doffing of PPE when in contact with COVID-19 residents;
• Reduce the number of non-essential staff who come in contact with residents;
• Reduce the movement of staff between patients with and without COVID-19 by cohorting staff and patients, if possible, and cohorting equipment;
• Performing frequent hand hygiene.

CMS Ex. 21 at 25.

The guidance addressed the management of residents with known or suspected COVID-19, and included that residents with known or suspected COVID-19 should be cared for in a private room with the door closed and not share bathrooms with other residents.  CMS Ex. 21 at 27.  The guidance stated that residents who had been in close contact with a confirmed COVID-19 patient (e.g., roommate or infected staff without wearing PPE) should be isolated and follow 14-day self-monitoring guidelines from CDC.  CMS Ex. 21 at 27 (citing CDC guidance).

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The Facility’s COVID-19 Outbreak in March and April 2020

On March 28, 2020, at the facility’s request, a state agency “strike team” tested two facility residents for COVID-19 and one of those residents tested positive.  CMS Exs. 4 at 11; 18 at 31.  Four days later, on April 1, 2020, the strike team returned and, although the facility requested tests for an additional 10 residents, the strike team had resources to test only five residents at that time.  CMS Exs. 4 at 11; 18 at 31.

On April 3, 2020, the strike team notified the facility that four of those five tests were positive.  CMS Exs. 4 at 11; 23 at 2-3.  The strike team gave further instructions to the facility, but the parties disagree about the substance of those instructions.  The facility’s DON, Ms. Piercy, a registered nurse, testified that a representative from the strike team, “whose first name I believe to be Brenda, told [her] that the [state agency] strike team would no longer make COVID-19 testing available to [the facility] due to the . . . limited availability of COVID-19 testing resources.”  P. Ex. 1 at 1.  Ms. Piercy further testified that the strike team also “instructed [her] that [the facility] should presume all of its residents to be COVID-19 positive and to implement transmission-based precautions, specifically droplet/contact precautions, per [CDC] guidelines.”  P. Ex. 1 at 1-2.  Ms. Piercy added that the conversation with “Brenda” on April 3, 2020, was by phone and that the facility’s Assistant DON (ADON), Ms. Waggoner, a registered nurse, was present in the room while the call was audible on the telephone’s speaker.  P. Ex. 6 at 2.  In her testimony, Ms. Waggoner stated that she was present and supported Ms. Piercy’s account of the communications from the state agency.  P. Ex. 5 at 1.

CMS submitted the testimony of Ms. Buroker, a registered nurse and the state agency’s Director of Long-Term Care.  CMS Ex. 23 at 1.  Ms. Buroker confirms that she communicated the results of the strike team’s COVID testing to the facility on April 3, 2020, but disputes the facility’s account of the instructions she gave:  “I do not have a specific memory of this conversation and certainly do not recall recommending, as alleged by [the facility], that it presume every resident to be positive for COVID and that it should implement transmission-based precautions for every resident.”  CMS Ex. 23 at 2-3.  Ms. Buroker testified instead that “[t]he only recommendation that I recall providing to any facility with positive cases that had exhausted its allotment of testing from the strike team was” to “presume every symptomatic resident to be positive for COVID and to implement transmission-based precautions for those residents,” which was “in accordance with the standard of care and accepted national standards.”  CMS Ex. 23 at 2‑3 (emphasis in original).

Although Petitioner focuses much of its briefing on these instructions, the instructions are immaterial to the question of whether Petitioner adhered to its infection control policies and ultimately complied with the Medicare participation requirements for infection control, which I discuss later in this decision.  Regardless of the specific instructions given, the facility began implementing transmission-based precautions for every resident.

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P. Ex. 1 at 1.  According to the facility, implementing transmission-based precautions for every resident “quickly depleted” its stock of PPE such that it discontinued facility-wide precautions after four days, on April 7, 2020.  P. Ex. 2 at 1-2; CMS Ex. 18 at 29.

Petitioner’s April 2020 Protocol

With limited availability of COVID-19 testing resources and a rapid depletion of PPE stock that Petitioner reports caused it to discontinue facility-wide precautions, the facility’s medical director, Dr. Hafid, reports that he directed the facility to implement a laboratory testing protocol to “assist in identifying residents of [the facility] with potential COVID-19 infection.”  CMS Exs. 18 at 29; 17 at 1 (also noting that “the purpose of the testing was not strictly for COVID-19[,] [r]ather, to identify the source/potential causal factor of the resident’s symptoms exhibited and/or complaint voiced”); P. Ex. 2 at 3 (also opining that “the immediate placement of those residents . . . with pre-existing conditions which were not new or worsening into transmission-based precautions would have depleted even more the already critically low supply of PPE”).  Dr. Hafid testified that the basis of the protocol was that “certain laboratory testing results/clinical findings had been observed to be indicative of COVID-19 infection as observed in the acute care setting.”  P. Ex. 2 at 2.  Petitioner acknowledges that the protocol “included . . . limiting the use of transmission-based precautions to only certain residents.”  P. Br. at 12.  Indeed, the protocol delayedtransmission-based precautions for certain residents who may have had symptoms of COVID-19 and withheld those precautions for asymptomatic residents who had been in close contact with a confirmed COVID-19 positive patient.

The protocol is described by a document signed by the facility’s management personnel titled, “Monitoring of Resident Symptoms in Determination of Necessary Actions.”  CMS Ex. 17.  Under the protocol, resident temperatures were taken every morning, and depending on a resident’s symptoms and/or complaints, a facility nurse would order laboratory tests and x-rays8 to help the facility determine the underlying cause of those symptoms.  CMS Ex. 17 at 1.  For instance, the facility would order the testing protocol for any resident who both (1) had a temperature greater than 100 degrees and (2) exhibited “new” respiratory symptoms.  CMS Ex. 17 at 2.  Consistent with CDC guidelines, the facility would presume that such a resident was symptomatic for COVID-19 and place the resident on transmission-based (droplet) precautions pending the results of the tests.  CMS Ex. 17 at 2.  The facility would then review the test results and determine whether to transfer the resident to a specialized unit.  CMS Ex. 17 at 2.

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The protocol also called for ordering the testing protocol for (1) any resident who had a temperature greater than 100 degrees but had no respiratory symptoms and (2) any resident who simply “voic[ed] a newly developed complaint or demonstrate[ed] a change in condition.”  CMS Ex. 17 at 2.  But the facility did not place residents in these categories on transmission-based precautions pending the results of the testing; the facility instead delayed implementing these precautions until after it received the testing results and a review of the results did not provide a rationale for the resident’s symptom(s).  CMS Ex. 17 at 2 (suggesting further that transmission-based precautions might still be withheld unless the resident’s undiagnosed symptoms included “a temperature of 100 degrees or greater, cough, shortness of breath, [or] decreased oxygen saturation.”).  Because residents in these categories may have been symptomatic due to COVID-19, the facility’s delay in placing these residents on transmission-based precautions departed from CDC guidance.9  See CMS Ex. 16 at 3 (facility COVID-19 policy reporting that symptoms of respiratory infection, for purposes of “identification and management of ill residents,” included cough, fever, and sore throat, and stating that the facility “shall cohort residents with symptoms of respiratory infection determined to be suspect or COVID-19 positive”).

The April 2020 Survey

The facility was still following its April 2020 protocol when the state agency surveyors began the survey on April 9, 2020.  Petitioner does not dispute that early in the survey, one of the surveyors, Ms. Creasey, observed three residents, Resident B, Resident C, and Resident D, in or around their respective rooms.  CMS Ex. 22 at 7-8.  The testing

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protocol had been ordered for all three residents in accordance with the facility’s protocol.  CMS Ex. 1 at 4.  Relevant here:

• Resident B:  Resident B’s roommate was presumed positive for COVD-19 and transferred to a specialized unit the day before, on April 8, 2020.  CMS Exs. 2 at 1 (Resident ID Key); 11 at 36 (Room 303 roommate transfer); see also CMS Ex. 5 at 26 (Resident B also presented with a low-grade fever of 99.2o F).
• Resident C:  Resident C exhibited cough, bilateral basilar ronchi and respiratory wheezes, also on April 8, 2020.  Several days prior, on April 3, 2020, Resident C’s roommate was presumed positive for COVID-19 and transferred to a specialized unit.  CMS Exs. 6 at 27; 10 at 2 (Room 412 roommate transfer).
• Resident D:  Resident D complained of cough and shortness of breath on April 6, 2020.  CMS Ex. 7 at 49.10

Notably, the surveyor observed that none of the residents were on transmission-based precautions.  CMS Ex. 22 at 7-8.  Each resident room’s door was open and none of the residents were isolated.  CMS Ex. 22 at 7-8.  The surveyor observed that there were no stop signs on the doors and no PPE was accessible from those rooms.  CMS Ex. 22 at 7‑8.  Just before the surveyor made her observations of Resident B, Resident C, and Resident D, the facility’s Administrator had indicated that those three residents had just received orders to be transferred to a special COVID-19 unit in a different facility because the facility’s laboratory process could not rule out COVID-19.  CMS Ex. 1 at 4.

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12. Petitioner failed to substantially comply with 42 C.F.R. § 483.80(a) when it failed to place Resident B, Resident C, and Resident D under transmission-based precautions, as required by its own policies that were based on CDC and state guidance.

Based on the guidance provided in Petitioner’s Infection Control Manual policies, which are based on CDC and state guidance, the facility should have implemented  transmission-based precautions for Resident B, Resident C, and Resident D because each one either had been in close contact with a roommate who was presumed to have COVID-19 (Resident B), had exhibited signs or symptoms of COVID-19 (Resident D), or had both exhibited signs or symptoms of COVID-19 and also been in close contact with a roommate who was presumed COVID-19 positive (Resident C).  However, the surveyor observed that those precautions were not in place during the morning of April 9, 2020.  By failing to adhere to its own policies, and in turn, CDC and state guidelines, the facility failed to help prevent the risk of spreading COVID-19 within the facility, which placed other residents at likely risk of serious harm.  See CMS Exs. 12 (facility policy addressing that transmission-based precautions protect other residents and personnel from the spread of confirmed or suspected infection); 16 (facility policy noting that its infection control policies outline the transmission-based precautions to be employed when caring for residents with respiratory infection).  Petitioner’s failure to adhere to its policies rendered it out of substantial compliance.

Ms. Creasey, citing CDC guidance, testified that “[a]ll categories of Transmission-Based Precautions include isolating the resident in a closed room, using appropriate [PPE] (which should be available outside or in close proximity to the resident’s room), and placing a stop sign on the resident’s room so that staff are aware of the applicable precautions.”  CMS Ex. 22 at 3.  Ms. Creasey further stated:

Consistent with the standard of care and long-standing infection prevention and control practices, the CDC and ISDH recommendations in place at the time of the April 13 survey to prevent and control COVID infections included the following:

1. For residents with signs or symptoms of COVID, immediately implement Transmission-Based precautions.  Absent the ability to conduct a COVID test, continue Transmission-Based precautions until at least 72 hours after resolution of symptoms and after 7 days have passed since symptom onset.
2. For residents who have been in close contact with a COVID-positive or presumed COVID-positive individual (such as a roommate), immediately implement Transmission-Based

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1. precautions.  Continue Transmission-Based Precautions for at least 14 days to monitor for onset of symptoms.

CMS Ex. 22 at 4; see CMS Exs. 1 at 12-13 (Statement of Deficiencies addressing similar CDC and ISDH guidance, along with the facility’s Infection Control Manual); 16 at 9 (facility policy containing substantially similar language).  Although Petitioner disputes Ms. Creasey’s testimony and observations, it does not challenge her discussion of its infection control policies or the CDC and state guidance that were in effect at the time of the March 2020 survey.

Petitioner’s arguments focus on its claims that when the strike team informed it that no additional COVID-19 testing was available, it had been told to presume all residents are positive for COVID-19 and to implement transmission-based precautions for all residents.  P. Br. at 6-12.  However, even assuming arguendo that it received this guidance from the strike team, it has failed to respond to, much less dispute, CMS’s arguments that this issue is immaterial to whether Petitioner was in compliance with infection control requirements when it disregarded its October 2015 and March 2020 policies in favor of an April 2020 testing protocol that delayed the implementation of transmission-based precautions and could not, in and of itself, yield a diagnosis of COVID-19.11

Petitioner does not contest the surveyor’s observations that transmission-based precautions were not in place for the three residents at issue.  Petitioner asserts more broadly that CMS “did not have ‘a valid legal basis’” for its allegations and remedies.  P. Br. at 20.  Petitioner argues, “but for the [state agency] instruction, the PPE would not have been depleted” and “[t]he regulatory violations alleged by CMS are completely inconsistent with the [state agency] instruction, and the [state agency] instruction is binding upon CMS.”  P. Br. at 19-20; see also P. Br. at 22 (“[The facility] duly complied with the [state agency] Instruction” and “[t]hat compliance was undertaken to provide ‘transmission based’ precautions to all residents of [the facility].”); P. Br. at 24 (“[D]espite the critical shortage of PPE directly caused by [the facility’s] adherence to the [state agency] Instruction, CMS stunningly has adopted the allegations of the Survey Document and has imposed civil money penalties.”).

To the extent Petitioner blames the state agency for the depletion of its PPE to the point where it did not have enough to place outside the rooms for the residents listed above, Petitioner’s position is unavailing.  Petitioner’s noncompliance with 42 C.F.R. § 483.80(a) is supported alone by its failure to implement transmission-based precautions

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that required the isolation of Resident B, Resident C, and Resident D, and the placement of appropriate signage.12

Petitioner’s focus on its “depleted” PPE is ultimately irrelevant as it ignores the other transmission-based precautions that were required to be in place.  As noted, pursuant to Petitioner’s policy, which invoked the guidance of CDC and state guidelines, residents who exhibited signs or symptoms of COVID and or had been in close contact with COVID-19 positive individuals were required to be isolated in their rooms with the door closed.  The facility was also required to post signs immediately outside of resident rooms indicating appropriate transmission-based precautions.  Regardless of whether the facility had adequate PPE stocks, it failed to implement those basic transmission-based precautions for Resident B, Resident C, and Resident D, and those failures constitute noncompliance for which Petitioner cannot blame the state agency as a defense.13

Further, Petitioner’s delay in implementing transmission-based precautions for Resident B, Resident C, and Resident D is attributable to its administration of its testing protocol which is a departure from its own policies, and in turn, CDC and state guidance.  The

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opinion of Dr. Schwartzman, a physician, epidemiologist, and chief infection control officer for a Department of Veterans Affairs medical center, is probative.  CMS Ex. 24 at 2.  Dr. Schwartzman simplistically and logically explained the serious risks of delaying the implementation of transmission-based precautions for residents suspected of being infected with COVID-19, stating:

The primary reason why it is inappropriate for a nursing home to conduct lab tests prior to deciding whether to implement Transmission-Based Precautions for certain residents is the attendant delay in waiting for the results.  Due to the rapid nature in which infectious diseases can spread within a nursing home during an outbreak, it is never appropriate to delay or forego implementation of transmission-based precautions for a resident who might be infected.  This is true even if the nursing home suspects that the resident’s symptoms are better or more likely explained by an alternative cause than the infectious disease.

CMS Ex. 24 at 6; see also CMS Ex. 22 at 4.

To the extent Petitioner argues that its conduct, including initiating the April 2020 testing protocol, was reasonable, I disagree with that argument.  P. Br. at 20, 22.  Dr. Schwartzman specifically addressed the tradeoff that Petitioner faced in making the decision to initiate its protocol, credibly opining that the “cost of failing to timely implement Transmission-Based precautions (i.e., allowing a potentially infectious resident to spread disease within the facility) greatly exceedswhatever benefit a facility could gain from conserving PPE.”  CMS Ex. 24 at 7.  A facility would justifiably be concerned about conserving its PPE during the timeframe at issue, even if it did not have a critical shortage of PPE.  But there are steps a facility can take to conserve PPE, and certain transmission-based precautions that were delayed did not require the expenditure of PPE.  See CMS Exs. 22 at 7; 24 at 7 (testimony that the standard of care of when facing a PPE shortage is to first exhaust all available options for increasing, extending, or re-using supply).

Finally, and quite significantly, Petitioner has not submitted evidence showing that its testing protocol would have provided the information necessary to identify COVID-positive residents.  Petitioner essentially relies on a single line of testimony from its medical director that the basis of the protocol was that “certain laboratory testing results/clinical findings had been observed to be indicative of COVID-19 infection as observed in the acute care setting.”  P. Ex. 2 at 2.  Petitioner has not elaborated on what those “testing results/clinical findings” were or how those specific observations in the acute care setting apply in the long-term care setting.  Petitioner’s stated rationale does not justify departing from its own infection control policies and delaying transmission-based precautions for those residents who may be positive for COVID-19.  Therefore, Petitioner should have followed those guidelines and initiated transmission-based

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precautions immediately for any residents suspected to be positive for COVID-19.  Petitioner’s failure to do so renders it out of substantial compliance.

13. Petitioner has not demonstrated that the immediate jeopardy determination was 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.  I must uphold CMS’s determination as to the level of a facility’s substantial noncompliance (which includes an immediate jeopardy finding) unless it is “clearly erroneous.”  42 C.F.R. § 498.60(c).  The DAB directs that the “clearly erroneous” standard imposes on a facility a heavy burden to show no immediate jeopardy and has sustained determinations of immediate jeopardy 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) (citing Florence Park Care Ctr., DAB No. 1931 at 27-28 (2004)).  A facility challenging an immediate jeopardy determination must prove that the harm or threatened harm does not meet any reasonable definition of “serious.”  Daughters of Miriam Ctr., DAB No. 2067 at 9 (2007).  Petitioner does not specifically argue that the immediate jeopardy determination was clearly erroneous, and I see no basis to make such a finding.  In fact, Petitioner’s briefing is silent for any challenges to the determination.  Likewise, Petitioner does not dispute the four-day duration of immediate jeopardy from April 8 through 11, 2020.

As previously discussed, the facility failed to adhere to its own polices when it delayed implementation of transmission-based precautions for at least three residents (Resident B, Resident C, and Resident D) while it awaited results of its testing protocol.  Petitioner cannot blame the state agency because, regardless of its stock of PPE, it still could have implemented other transmission-based precautions for residents with suspected COVID-19, to include isolating those residents in their rooms with the doors closed.  Its failure to implement transmission-based precautions increased the risk of spreading COVID-19 within the facility, which placed other residents at likely risk of serious harm.  Dr. Schwartzman opined, “COVID, especially in nursing home residents with advanced age and/or other comorbidities, can lead to pneumonia and respiratory failure (among other severe symptoms), and result in death.”  CMS Ex. 24 at 8-9.  Based on these findings, I conclude that the immediate jeopardy determination was not clearly erroneous.

14. A per-day CMP of $8,830 is a reasonable enforcement remedy for the immediate jeopardy noncompliance.

If a facility is not in substantial compliance with program requirements, CMS has the authority to impose one or more of the enforcement remedies listed in 42 C.F.R. § 488.406, to include a CMP.  In determining whether the CMP imposed against Petitioner is reasonable, I apply the factors listed in 42 C.F.R. § 488.438(f):  1) the

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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.  The absence of culpability is not a mitigating factor.  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.  Unless a facility contends that a particular regulatory factor does not support the CMP amount that CMS proposed, an ALJ must sustain the CMP.  Coquina Ctr., DAB No. 1860 at 32 (2002).

The DAB has explained that “it is settled law that ALJ review of the reasonableness of CMP amounts imposed by CMS is de novo.”  Fireside Lodge Retirement Ctr., Inc., DAB No. 2794 at 19 (2017).  I consider whether the evidence supports a finding that the amount of the CMP is at a level reasonably related to an effort to produce corrective action by a provider with the kind of deficiencies found, and in light of the above factors.  I am neither bound to defer to CMS’s factual assertions, nor free to make a wholly independent choice of remedies without regard for CMS’s discretion.  See, e.g., Barn Hill Care Ctr., DAB No. 1848 at 21 (2002).  The DAB has explained that “[t]he determination of whether a CMP amount is reasonable is a conclusion of law, not a finding of fact.”  Cedar Lake Nursing Home, DAB No. 2344 at 12 (2010), aff’d, 619 F.3d 453, 457 (5th Cir. 2010).

The regulations specify that a CMP that is imposed against a facility on a per-day basis will fall into one of two ranges.  42 C.F.R. §§ 488.408, 488.438.  The upper CMP range of $6,808 to $22,320 per day, as adjusted annually under 45 C.F.R. part 102, is applicable here.  42 C.F.R. § 488.438(a)(1)(i).  In assessing the reasonableness of a CMP, an ALJ looks at the per-day amount, rather than the total accrued CMP.  See Kenton Healthcare, LLC, DAB No. 2186 at 28 (2008).

CMS imposed a CMP of $8,830 per day for four days of immediate-jeopardy-level noncompliance from April 8, 2020, through and inclusive of April 11, 2020, for a total CMP of $35,320.  The per-day CMP of $8,830 is at the low end of the $6,808 to $22,320 CMP range applicable at that time for deficiencies that pose immediate jeopardy.  See 45 C.F.R. § 102.3; 85 Fed. Reg. 2869, 2880 (Jan. 17, 2020).

Petitioner has not argued that any of the enumerated regulatory factors warrant a reduction of the per-day CMP, and it does not cite any regulatory basis to challenge the reasonableness of the per-day CMP.

The per-day CMP of $8,830, which is less than 15 percent of the allowable per-day CMP amount that could have been imposed, is unquestionably reasonable, if not unreasonably low, considering the egregiousness of the deficiency.  Petitioner implemented its April

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2020 protocol in place of its existing infection control policies that included transmission-based precautions to protect residents from the spread of infectious disease.  While I acknowledge that Petitioner, like most every facility in the early days of the COVID-19 pandemic, had understandable concerns about extending its PPE supply, it is simply incomprehensible why it would disregard its own infection control policies that promoted infection control through means such as isolation that spared it of expending its precious PPE resources.  Further, even though Petitioner’s existing policy contemplated that symptoms such as cough, fever, or sore throat sufficed as a basis to trigger transmission-based precautions such as isolation, Petitioner implemented a protocol that required objective diagnostic evidence, via a testing panel, that could not immediately be developed.  Further, this testing, which did not include a COVID-19 test, was incapable of either providing a diagnosis of COVID-19 or ruling out COVID-19 infection.  The facility was unable to attribute the symptoms of Resident B, Resident C, and Resident D to anything other than COVID-19, and the delay in placing these residents under transmission-based precautions increased the risk of COVID transmission within the facility and placed other staff and residents at likely risk of serious harm.

In addition to Petitioner’s high degree of culpability, as addressed above, Petitioner’s past noncompliance history further supports the CMP amount as Petitioner was cited with another immediate-jeopardy level deficiency only months prior to the April 2020 survey, in August 2019.14  CMS Ex. 25 at 1.  The per-day CMP imposed in this case is reasonable pursuant to 42 C.F.R. § 488.438(f), and a much higher per-day CMP would also have been entirely reasonable.

V. Conclusion

For the reasons discussed above, I conclude that the facility was not in substantial compliance with the Medicare participation requirements from April 8, 2020, through and inclusive of April 11, 2020, and that the immediate jeopardy determination was not clearly erroneous.  I also conclude that the per-day CMP of $8,830 amount is reasonable.