Parkview Manor Nursing and Rehabilitation, DAB CR6073 (2022)

DECISION

I sustain the determination of the Centers for Medicare and Medicaid Services (CMS) to impose the following remedies against Petitioner, Parkview Manor Nursing and Rehabilitation, a skilled nursing facility:

• Civil money penalties of $8,995 for each day of a period beginning on November 13, 2020 and running through November 18, 2020;
• Civil money penalties of $330 for each day of a period beginning on November 19, 2020 and running through January 24, 2021; and
• Denial of payment for new Medicare admissions for each day of a period beginning December 23, 2020 and running through January 24, 2021.

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I. Background

CMS filed exhibits identified as CMS Ex. 1-CMS Ex. 26. Petitioner filed exhibits identified as P. Ex. 1-P. Ex. 37 and P. Ex. 39-P. Ex. 40. The parties objected to my receiving certain exhibits. CMS moved for summary judgment and Petitioner opposed the motion. In opposing the motion, Petitioner filed three additional exhibits that it identified as P. Ex. A-P. Ex. C.

I denied the motion for summary judgment. I overruled Petitioner’s objections to CMS’s exhibits and received CMS’s exhibits into the record. I sustained CMS’s objections to certain of Petitioner’s exhibits, consisting of P. Ex. 2-P. Ex. 9, P. Ex. 10 (page 1), P. Ex.11 (pages 2 and 3), P. Ex. 15, P. Ex. 21 (page 3), P. Ex. 22, P. Ex. 26, and P. Ex. 27-P. Ex. 30. I received Petitioner’s remaining exhibits into the record.

I scheduled this case for an in-person hearing. The parties then agreed that the case could be heard and decided based on their written exchanges and the exhibits that I received into evidence. CMS requested that it be permitted to file a final brief and I granted that request.

I decide this case based on the written record.

II. Issues, Findings of Fact and Conclusions of Law

A. Issues

The issues are whether Petitioner failed to comply with a Medicare participation requirement, whether its noncompliance was so egregious as to put residents of its facility at immediate jeopardy, and whether CMS’s remedy determinations are reasonable.

B. Findings of Fact and Conclusions of Law

CMS asserts that Petitioner failed to comply substantially with the regulation governing infection control at skilled nursing facilities, 42 C.F.R. § 483.80.1 The regulation requires a skilled nursing facility to establish an infection control program that, among other things: establishes a system for preventing, identifying, investigating, and controlling infections among all residents, staff, volunteers, visitors, and contract personnel, following accepted national standards; promulgates written standards, policies and procedures for the infection control program; includes reporting criteria; utilizes standard and transmission-based precautions in order to prevent the spread of infections; and contains an explanation of when and how isolation of residents will be employed. 42

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C.F.R. § 483.80(a)(1)-(2). The facility must adopt a system for recording incidents of infection and documenting any corrective actions. 42 C.F.R. § 483.80(a)(4). There are additional requirements governing handling of linens and a mandatory annual review by the facility of its infection control program. 42 C.F.R. § 483.80(e), (f).

The regulation does not prescribe the specific measures a skilled nursing facility must implement to satisfy the regulatory requirements. The regulation gives the facility flexibility to design a program that meets the unique needs of residents, staff, volunteers, visitors, and contract personnel. But whatever the facility adopts must comply with accepted infection control standards. And the facility must implement whatever program it adopts. Golden Living Center – Superior, DAB No. 2768 at 5 (2017).

CMS’s noncompliance allegations address Petitioner’s alleged failures to comply with its own infection control program and applicable infection control standards during the ongoing Covid-19 (Covid) pandemic.

I take notice that Covid is a disease that is both highly contagious and potentially lethal, especially for those individuals who are so aged and/or infirm as to qualify for residence in a skilled nursing facility. The illness has exerted a terrible toll on residents of nursing facilities. As of September 2020, in Texas – where Petitioner’s facility is located – 62 out of every 1000 skilled nursing facility residents had died from Covid. COVID-19 death rate in U.S. nursing homes, as of September 27, 2020, by state, Statistica.com, https://www.statista.com/statistics/1169571/rate-nursing-home-resident-covid-deaths-by-state/ (last visited May 9, 2022).

Covid’s deadliness among the aged and infirm and its ease of transmission impose heavy burdens on skilled nursing facilities to scrupulously develop and apply infection control procedures that comport with applicable standards of care for infection control. Failure by a facility to develop, implement, or rigorously enforce its infection control procedures serves as an invitation for Covid to enter the premises, spread among residents, and kill at least some of them.

Petitioner argues that the test of its compliance is whether the actions it took were reasonable under the circumstances.  Petitioner’s Response to CMS’s Motion for Summary Judgment (Petitioner’s brief) at 2-3. The suggestion in Petitioner’s argument seems to be that there is a certain margin of error built into the regulatory requirements. I disagree. Here, there is no margin of error. The infectiousness and dangers posed by Covid require a skilled nursing facility to be absolutely rigorous in implementing its infection control procedures. Nothing suffices short of complete compliance with whatever procedures the facility adopts that are consistent with applicable standards of care.

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CMS charges that Petitioner violated its infection control procedures and accepted public policy for control of Covid. Specifically, CMS alleges that Petitioner did not:

• “cohort” its residents to prevent the spread of infection. The term “cohort” means segregating infected and potentially infected residents from uninfected residents;
• immediately isolate a Covid-positive resident from other residents in its facility;
• report positive Covid test results to the appropriate authorities;
• ensure that personal protective equipment (PPE) was readily available to members of Petitioner’s staff;
• ensure that staff followed proper PPE and hand hygiene procedures; and
• enforce its own restrictions on visits to its facility.

I consider each of these allegations separately. The evidence amply supports each of them, notwithstanding Petitioner’s arguments and contentions. Petitioner failed in multiple ways to comply with state requirements and Petitioner’s own procedure for addressing Covid. Each of these failures, standing alone, is egregious noncompliance that put residents of Petitioner’s facility in immediate jeopardy. That Petitioner was noncompliant in multiple respects underscores the likelihood of harm or death to residents of Petitioner’s facility.2

1. Failure to cohort residents

The Texas Health and Human Services Commission published guidance for Texas nursing facilities for prevention, management, and reporting of Covid outbreaks. CMS Ex. 4. The language and tone of the guidance make it clear that it is more than mere suggestions but, rather, policy declarations with which Texas nursing facilities, including Petitioner, were obligated to comply.

The preamble of this guidance states:  “Prompt recognition and immediate isolation of probable [Covid] cases is critical to prevent outbreaks in residential facilities.” CMS Ex. 4 at 1. That language, at the very inception of the guidance, makes it clear in no uncertain terms that skilled nursing facilities, including Petitioner, had to be scrupulous in segregating possibly infected residents from those who are not infected. In practice that

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meant that infected residents must not be housed with uninfected residents but equally important, it meant that residents whose infection status was unknown could not be housed with uninfected residents.  Petitioner was obligated to treat every new entrant to its facility as potentially being a Covid carrier until that resident’s status was clearly established.

The guidance states that any resident who tests positive for Covid must immediately be isolated from other residents. CMS Ex. 4 at 6. It instructs each facility to create a plan to cohort residents with symptoms of respiratory infection and Covid, including dedicated staff to work only with affected residents. Id. It tells facilities that residents suffering from Covid should be accommodated in a separate unit, with separate bathing or showering facilities, designated for care of individuals suffering from Covid. Id. at 7. It describes infection control zones that facilities should adopt as:  “cold,” meaning an uncontaminated area; “warm,” consisting of a potentially contaminated area, and “hot,” meaning an area that is contaminated. It instructs facilities to assign staff to work uniquely with each cohort and not to change staff designations from one day to the next. Id. at 11.

Petitioner adopted an infection control procedure that it intended to comply with the Texas Health and Human Services Commission guidance. P. Ex. 33. It required Petitioner to designate a wing of its facility as an isolation area and to place residents in private rooms on strict isolation precautions. Id. at 10. It stated that Petitioner would cohort residents who tested positive for Covid if a private room was unavailable. Id.

Petitioner followed neither the Health and Human Services Commission guidance nor its own procedure. It placed newly admitted residents with its uninfected resident population even though the infection status of the newly admitted residents was unknown. That failure to cohort newly admitted residents potentially exposed uninfected residents to Covid and was a critical failure by Petitioner to follow accepted infection control practices and its own infection control procedures.

Petitioner offered a floor plan of its facility that shows the rooms that Petitioner reserved for residents infected with Covid (“Hot Hall”) and those whose infection status was unknown (“Warm Hall”).  P. Ex. 1. Uninfected residents were housed in the remaining rooms. The Hot and Warm Halls are resident rooms that form a distinct subdivision of the facility, separated from the remaining residents’ rooms. Id. I infer that it was Petitioner’s plan to house only infected residents in its Hot Hall and only residents whose Covid infection status was unknown in its Warm Hall. Logically, any newly admitted resident to Petitioner’s facility would have to be housed in the Warm Hall until that resident’s infection status was established. At that point – but not before – the resident would be transferred either to Petitioner’s Hot Hall or to a part of the facility that housed uninfected residents.

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But that is not what happened in the cases of two newly admitted residents, identified as Residents #s 2 and 3. Petitioner housed both residents with uninfected residents before ascertaining whether Residents #s 2 and 3 were infected with Covid.

Petitioner admitted Resident # 2 on November 13, 2020.  CMS Ex. 9 at 7. She arrived at Petitioner’s facility with an order from a physician instructing that she be kept in strict isolation for 14 days due to her having been exposed to Covid. Id. at 9. However, Petitioner’s records establish that Petitioner housed Resident # 2 in Room 39-A and Room 29 of its facility. Id. at 1. Petitioner’s floor plan establishes that both rooms were in the wing of the facility reserved for uninfected residents.  P. Ex. 1. On November 17, 2020, a state surveyor observed Resident # 2 living with and among uninfected residents. CMS Ex. 7 at 3.

Petitioner admitted Resident # 3 to its facility on October 30, 2020. As was the case with Resident # 2, Resident # 3 entered the facility with a physician’s order that he be in strict isolation for 14 days due to possible exposure to Covid. CMS Ex. 10 at 12, 14. Notwithstanding, Petitioner housed Resident # 3 in Room 14-B of its facility. That room was neither in the Warm nor Hot Hall but rather, was part of the facility reserved for uninfected residents. P. Ex. 1.

Commingling Residents #s 2 and 3 with uninfected residents risked spreading Covid. Perhaps other residents might have been protected had these two been placed in private rooms with the doors shut and under strict infection control even if those rooms were in a part of the facility that housed uninfected residents. However, Petitioner did not prove that it followed this procedure. There is no persuasive evidence to show that the two residents were barred from interacting with other residents during their stays in the part of Petitioner’s facility reserved for uninfected residents. Moreover, Petitioner has not shown that Residents #s 2 and 3 were treated only by dedicated staff as the isolation protocol published by the Texas Health and Human Services Commission required.

Petitioner contends flatly that it did cohort new admissions. Petitioner’s brief at 7-8. It relies on the declarations of two individuals as support for this assertion, Joseph Davis and Joshua Henderson. P. Ex. 35; P. Ex. 36; P. Ex. 41; P. Ex. 42.  Mr. Davis is the administrator of Petitioner’s facility. Mr. Henderson is the regional director of the corporation that owns Petitioner.  In their declarations, both witnesses assert that Petitioner’s Warm Hall was expandable to account for increased numbers of residents who might have been exposed to Covid. P. Ex. 41 at 1; P. Ex. 42 at 1. They contend that when Resident # 3 was housed in Room 14-B, that room was part of the expanded Warm Hall. Consequently, they and Petitioner assert that Resident # 3 was appropriately isolated from residents who had not been exposed to Covid.

I find these declarations to be unpersuasive.  First, neither Mr. Henderson nor Mr. Davis address Petitioner’s housing of Resident # 2 with Petitioner’s general resident population

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during her quarantine period. Neither witness contends that either Room 29 or 39-A, where the resident resided, were part of Petitioner’s allegedly expanded Warm Hall. The floor plan presented by Petitioner establishes that these rooms were not part of the Warm Hall.  P. Ex. 1.

Second, I am not persuaded by the declarations that Petitioner had expanded its Warm Hall to include Room 14-B when it housed Resident # 3 in that room. Petitioner offered no documentation to show how its Warm Hall was expanded or when it was expanded. The only evidence presented by Petitioner showing which rooms were used to cohort residents is P. Ex. 1 and that clearly shows Room 14-B not to be part of Petitioner’s Warm Hall.

Finally, Petitioner’s assertions do not address the issue of whether Petitioner dedicated separate staff to treat Residents #s 2 and 3 as was required by the Health and Human Services Commission guidance.

2. Failure immediately to isolate a Covid-positive resident from other residents of the facility

The Texas Health and Human Services Commission explicitly instructs nursing facilities to take immediate action to isolate from other residents any resident testing positive for Covid. CMS Ex. 4 at 6. Petitioner’s Covid procedure dovetails with state requirements. Petitioner’s policy directs that immediate infection prevention and control measures be implemented once a resident is known to be Covid-positive. P. Ex. 33 at 10. Petitioner ordered its staff immediately to isolate any resident whose Covid-positive status is known. Id.

These directives – both from the Texas Health and Human Services Commission and from Petitioner’s management – do not allow for delay. “Immediate” means just that. However, Petitioner failed to isolate a Covid-positive resident immediately, leaving that resident in a room with an uninfected resident for an extended period.

On November 11, 2020, Petitioner learned that one of its residents, Resident # 4, tested positive. CMS Ex. 6 at 3. Petitioner began testing other residents for Covid shortly thereafter.

At around 5:55 p.m. on the afternoon of November 16, 2020, Petitioner received test results for Resident # 13, establishing that this resident was infected with Covid. P. Ex. 17 at 1.  At around the same time, Petitioner received test results for Resident # 13’s roommate, Resident # 12, showing that Resident # 12 was uninfected. However, Petitioner did not move Resident # 13 to Petitioner’s Hot Hall until after 11 a.m. on November 17, 2020. P. Ex. 18 at 1. Thus, Resident # 13, infected with Covid, remained in the same room with uninfected Resident # 12 for approximately 16 hours from the

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time when Petitioner was apprised that Resident # 13 was infected. Leaving these two residents – one infected, the other uninfected – together for so long plainly violated both the Texas Health and Human Services Commission guidance and Petitioner’s own policy.

Petitioner contends that it did not receive positive test results for Resident # 13 until sometime during the morning of November 17, 2020. I find that assertion to be unsupported. Petitioner does not deny that the results were transmitted electronically to Petitioner’s facility and received by Petitioner on the afternoon of November 16. Rather, it asserts that no member of the staff became aware of those results until the next day. Petitioner’s brief at 12-13 n.5. That assertion provides no excuse to Petitioner. Its argument boils down to claiming relief from responsibility because its staff was remiss in looking at electronic mail transmissions. Error is no excuse in this case.  Petitioner doesn’t deny that it had staff on duty during the evening of November 16 and the early morning hours of November 17. The staff should have looked at the mail.

Petitioner also contends that Texas Health and Human Services Commission policy is to allow a facility 24 hours to isolate a Covid-positive resident.  Petitioner’s brief at 12-13 n.5. As support, it offers Mr. Davis’s declaration. P. Ex. 36 at 6 n.3. This is a bald assertion without any foundation in fact and I find it not to be credible.  Petitioner cites to no document from the Texas Health and Human Services Commission as support.  Moreover, and as I have discussed, both the Texas Health and Human Services Commission and Petitioner’s own policy require immediate isolation of a Covid-positive resident. “Immediate” does not mean a 16-hour delay.

Finally, Petitioner asserts that it may take hours to accomplish a resident move, suggesting that the 16-hour delay in isolating Resident # 13 was somehow reasonable. Petitioner’s brief at 12-13 n.5. However, Petitioner’s own policy does not allow for such a delay and waiting so long clearly was not reasonable, given the highly infectious nature of Covid and the potentially lethal consequences of infection.

3. Failure to report positive Covid test results

Both the federal and Texas governments require that nursing facilities report weekly to the Centers for Disease Control any suspected and confirmed cases of Covid among residents and staff. CMS Ex. 4 at 15. Petitioner’s infection control procedure requires staff to notify state and local health departments of any positive cases of Covid. Additionally, Petitioner’s procedure directs staff to notify the local health department immediately of any suspected cases of Covid. P. Ex. 33 at 35.

Petitioner failed to comply with these requirements. In interviews, Petitioner’s director of nursing and administrator admitted that three individuals working at Petitioner’s facility tested positive for Covid in October 2020.  CMS Ex. 7 at 9. However, Petitioner

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failed to report these results, ostensibly because the results were from rapid tests and not from a more definitive test. Id.

This failure to notify plainly violated state requirements and Petitioner’s own policy. The fact that the three individuals tested positive on rapid tests was a red flag that triggered notification responsibilities. Waiting for some more definitive confirmation of status was not permitted under applicable requirements or Petitioner’s own procedure.

Petitioner argues that its reporting obligation was limited to reporting only “laboratory confirmed cases.” Petitioner’s brief at 24. It argues that test results from rapid tests have a high rate of false positives and are not confirmed by a laboratory. Therefore, according to Petitioner, it was under no obligation to report the positive test results that Petitioner received in October 2020.

As support for this argument Petitioner cites to an excerpt from the Texas Health and Human Services Commission policy. P. Ex. 34 at 43. This excerpt defines a confirmed outbreak of Covid as being one or more laboratory confirmed cases and it directs that all confirmed outbreaks be reported. However, neither this excerpt nor other portions of the same document limit reporting requirements to laboratory confirmed cases as Petitioner contends. As I have discussed, the Texas Health and Human Services Commission requires reporting of both suspected cases and confirmed cases of Covid. CMS Ex. 4 at 15. Positive rapid test results at the very least raise the suspicion that the individual testing positive has Covid, triggering reporting requirements.

4. Failure to ensure that personal protective equipment was readily available to members of Petitioner’s staff 

Petitioner’s infection control procedure directed staff to wear full PPE in caring for any resident who had tested positive for Covid or who was suspected of having Covid. P. Ex. 33 at 2-3. CDC guidelines for PPE define PPE as including an N95 mask or respirator, a face shield or goggles, and a gown. P. Ex. 33 at 89, 120, 122. I take notice that an N95 mask or respirator is a device that is specifically designed to serve as a barrier to the transmission or intake of virus particles. Masks that are not designated as N95 may lack the capability to block the passage of virus particles to and from the wearer.

Petitioner’s policy is consistent with that of the Texas Health and Human Services Commission. That entity requires that full PPE be worn, assuming such equipment is available, when treating residents who are positive for Covid or who have an unknown status. P. Ex. 6 at 9.

There is no dispute that as of November 2020, Petitioner had an adequate supply on hand of N95 masks, hand sanitizer, and gowns. CMS Ex. 3 at 20-21. But Petitioner did not make equipment readily available to its staff, in violation of its policy. Petitioner’s

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infection control procedure described a specific PPE control area in its facility, located at the facility entrance/exit, at which staff would don PPE before entering the facility at the beginning of a shift. P. Ex. 33 at 1. However, N95 face masks and face shields or goggles were not available at this location on November 17, 2020, during the compliance survey of Petitioner’s facility. CMS Ex. 7 at 12.

Petitioner offered no evidence to rebut surveyors’ findings that it was not supplying its staff with N95 masks at its PPE control area. Petitioner contends that it had adequate PPE on hand for its staff as of November 2020. Petitioner’s brief at 17. However, and as I have stated, this is not in dispute. What is at issue is whether Petitioner made such equipment available to staff at the location that it designated for staff to don such equipment. The evidence shows unequivocally that it did not.

This failure is not some technical or harmless omission on Petitioner’s part. As I shall discuss in the next subpart, surveyors observed staff not wearing PPE in circumstances where they should have worn such equipment. It is reasonable to infer that Petitioner’s failure to reinforce the requirement that staff wear PPE by making it available at the PPE control area led to staff ignoring the requirement that they wear such equipment.

5. Failure to ensure that staff followed proper personal protective equipment and hand hygiene procedures

Surveyors documented multiple instances in which members of Petitioner’s staff did not comply with CDC requirements, Texas Health and Human Services Commission directives, and/or Petitioner’s infection control procedures in that they did not wear or utilize PPE as was required.

Surveyors observed staff not complying with masking and face shield requirements. Resident # 3, whose circumstances I have discussed previously, was newly admitted to Petitioner’s facility and was under a physician’s order to be strictly isolated until the resident’s Covid status could be determined. That was also the case with Resident # 1. CMS Ex. 8 at 5. Resident # 6 had been exposed to Covid. CMS Ex. 12 at 1, 7. Petitioner’s staff were required to wear face masks and face shields or goggles when treating these residents due to the residents’ possible infection with Covid. P. Ex. 33 at 2-3. Surveyors observed staff failing to follow this requirement when providing care for these residents. A surveyor observed a certified nursing assistant wearing a cloth mask  – not the required N95 mask – while providing care for Resident # 3. CMS Ex. 7 at 3-4.  A surveyor observed a staff member entering Resident # 1’s room without wearing a face shield or goggles. CMS Ex. 3 at 3. A staff member was seen not wearing a face shield or goggles when entering Resident # 6’s room. CMS Ex. 6 at 3.

Petitioner’s infection control procedure included a section governing hand hygiene. The procedure instructed staff to wash their hands after assisting residents. P. Ex. 33 at 16.

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Petitioner clarified that requirement to direct that staff must wash hands after serving each tray of food to a resident and before entering each resident’s room. P. Ex. 32 at 1, 17. Petitioner stressed to its staff that they would put residents at risk if they did not perform hand hygiene on all required occasions. Id. at 36. However, and notwithstanding these requirements, a surveyor observed a certified nursing assistant entering three separate rooms to deliver meals without performing hand hygiene before each delivery. CMS Ex. 7 at 11.

The CDC directs that facility staff should not reuse disposable gowns because the risks to residents from possible contamination of the gowns outweigh the benefits of wearing them. CMS Ex. 24 at 4. Those risks become aggravated if a member of a facility’s staff reuses a gown that has been previously worn while that staff member or another staff member provided treatment to a resident who has tested positive for Covid or whose infection status is unknown. The CDC has also issued extensive and detailed instructions concerning how to wear a gown and how to dispose of it after use.

Petitioner did not have a clearly expressed written policy for staff’s use and disposal of gowns. CMS Ex. 7 at 12. Petitioner’s administrator admitted that staff could reuse gowns even though there were ample disposable gowns available. Id. Reuse was supposed to be limited to specific resident rooms.  In other words, staff members were permitted to reuse a gown when treating a specific resident but were not supposed to use the same gown for treating another resident. Id.

I find that the absence of clear directives to staff about gown use constituted noncompliance with regulatory requirements because that absence caused confusion among the staff and resulted in the staff engaging in inconsistent and dangerous practices. Staff had different interpretations as to what was appropriate or permitted. CMS Ex. 7 at 9-12. Some staff members reused gowns but others felt uncomfortable reusing them. At least one staff member discarded a gown after each use while another rolled a gown up and put it into her pocket so that it could be carried for possible reuse. Id.

Petitioner’s inchoate gown policy resulted – almost certainly inevitably – in staff improperly using gowns in violation of CDC policy and national standards for infection control. For example, Petitioner’s administrator was observed donning a gown that hung outside the door of a Covid-positive resident’s room (Resident # 14) and wearing it into the room of another resident (Resident # 15). CMS Ex. 7 at 12. Staff were observed wearing the same gown while entering multiple residents’ rooms. A staff member was observed wearing a gown while entering Resident # 13’s room (this resident had tested positive for Covid) and then wearing the same gown while delivering food to another resident. Id. at 10-11. A surveyor observed a certified nursing assistant delivering food to more than one resident’s room while wearing the same gown. Id. at 11.

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I find to be unavailing Petitioner’s arguments concerning its PPE policies and implementation of those policies.

Petitioner describes at length the in-service training it gave to its staff concerning availability and use of PPE. Petitioner’s brief at 14-15.  However, CMS does not charge that Petitioner failed to provide in-service training. The noncompliance that CMS alleges and that I sustain occurred despite the in-service training that Petitioner may have provided. That in-service training occurred thus does not in any respect counteract the noncompliance that the record establishes.

Petitioner asserts that allegations that its staff were reusing gowns for Covid positive residents are false. Petitioner’s brief at 15-16.  This assertion is belied by the evidence that I have cited. Surveyors made eyewitness observations of improper gown reuse by staff and Petitioner did not rebut them with evidence to undercut the credibility of those observations.

Petitioner seems to suggest that Petitioner’s policy was to permit reuse of gowns only in providing care to uninfected residents and not elsewhere in the facility. Petitioner’s brief at 16. It also contends that the Texas Health and Human Services Commission expressly allows reuse of gowns when supply limitations require reuse. Id. According to Petitioner, that was the case at Petitioner’s facility.

These assertions are simply not supported by the evidence. As I have discussed, CMS offered the eyewitness testimony of a surveyor that staff were reusing gowns to treat residents who were either Covid positive or who had unknown Covid status. Petitioner offered no eyewitness to deny these observations.3 Furthermore, there was no shortage of gowns at Petitioner’s facility when staff were observed to be reusing them improperly.  As of November 17, 2020, Petitioner had 19,600 gowns on hand for staff use. CMS Ex. 3 at 20.

Petitioner contends that it exceeded the requirements of relevant guidelines because it utilized gowns in all care scenarios and for treatment of all residents, including those who tested negative for Covid. Petitioner’s brief at 18. That may be so, but it is irrelevant to the issue of whether staff improperly wore gowns. CMS’s allegations – established by the evidence – are that Petitioner’s gown policy was inchoate and not clearly communicated and that Petitioner’s staff wore gowns improperly. That Petitioner’s staff

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wore gowns generally does not detract one iota from the evidence of noncompliance that I have cited.

Petitioner contends that it violated no requirements by allowing its staff to wear masks other than N95 respirators prior to Covid infection being identified on its premises. Petitioner’s brief at 18. This argument is a red herring. The noncompliance established in this case occurred after residents became infected with Covid.

Petitioner asserts that its staff engaged in proper hand hygiene. Petitioner’s brief at 19. However, as is the case with gown use, Petitioner premises its claim on unreliable hearsay expressed in Mr. Davis’ and Mr. Henderson’s declarations. I do not find that these hearsay assertions rebut the eyewitness testimony of a surveyor.

6. Failure by Petitioner to enforce its own restrictions on visits to its facility

The Texas Health and Human Services Commission, citing a CDC memorandum, characterized restricting visitors to a nursing facility other than those deemed medically necessary as an important measure to prevent introduction of the Covid virus. CMS Ex. 4 at 1.

Petitioner’s policy was to allow each resident to designate two permanently assigned visitors and/or essential caregivers. P. Ex. 33 at 6. Visitation was allowed only between nine a.m. and six p.m. It established a time limit of 30 minutes per visit. It provided for documentation of each visit. A visitor was required to provide a negative Covid test result obtained within the previous 14 days or a negative rapid test result upon entry to the facility. Visitors were to be given training regarding infection control and Covid symptoms. Id.

Petitioner violated this policy in allowing outside caregivers (sitters) to attend to a resident, Resident # 4. The sitters were requested by the resident’s family because the resident was a fall risk. CMS Ex. 5; CMS Ex. 6. Petitioner allowed the two sitters to attend to Resident # 4 around the clock even though Petitioner’s policy placed strict limitations on when visitors, including outside caregivers, could visit the facility and for how long. CMS Ex. 6 at 3.

Allowing around-the-clock sitters to be with Resident # 4 may have been a benefit to the resident but it also was a substantial convenience to Petitioner because it alleviated the staff of the burden to play close attention to Resident # 4. It was a blatant violation of Petitioner’s visitation policy, made more so by the fact that it was done with knowledge by Petitioner that outside sitters posed a risk of introducing Covid into Petitioner’s facility. Indeed, in October 2020, a sitter for Resident # 4 had tested positive for Covid. CMS Ex. 7 at 9.

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The risk attendant to allowing full time sitters into the facility was not limited to Resident # 4 but extended to all of Petitioner’s residents. Resident # 4 tested positive for Covid on November 11, 2020 and her infection almost certainly came from one or both of her sitters, inasmuch as both of them tested positive for Covid on or about the same date. P. Ex. 11 at 1. Once Resident # 4 became infected, Covid spread rapidly through Petitioner’s facility.

Petitioner admits that it allowed sitters to attend to Resident # 4 24 hours per day. Petitioner’s brief at 8. It contends that having these sitters was the resident’s family’s “absolute prerogative.” Id. It does not dispute that allowing these sitters violated Petitioner’s infection control policy. Nevertheless, Petitioner asserts that Resident # 4’s family – and by extension, any resident – had an absolute right to trump the procedure that Petitioner may have enacted to prevent the spread of Covid in its facility.

In making this argument Petitioner attempts to draw a distinction between what it deems to be medically necessary personnel and mere visitors. As Petitioner would have it because the sitters were medically necessary, they were entitled to be on Petitioner’s premises as often and as for as long as Resident # 4’s family requested. Petitioner’s brief at 9.

This argument is flawed. First, Petitioner’s infection control policy does not distinguish between “visitors” and “essential caregivers.” P. Ex. 33 at 6. It plainly limits all visits to its facility to 30 minutes and between the hours of nine a.m. and six p.m. Whether or not the sitters for Resident # 4 were “essential caregivers,” they were subject to the restrictions on visitation that Petitioner established.

Second, Petitioner hasn’t offered proof that the sitters assigned to Resident # 4 were medically necessary outside personnel. I do not take issue with the argument that Resident # 4 may have needed close, even continuous, watching due to her mental condition (she suffered from dementia) and her risk of falling. But Petitioner has offered no evidence to show that such watching necessitated the presence of individuals other than Petitioner’s own staff. Petitioner had personnel who presumably were qualified to keep Resident # 4 under observation. Bringing in outside sitters may have lifted a burden from Petitioner’s staff but that isn’t the same as establishing that they were essential.

Finally, Petitioner offered nothing to prove that a skilled nursing facility in Texas could waive the state’s policy to confine visitors during the Covid pandemic to those individuals who are deemed to be medically necessary. As I have stated, Petitioner offered no evidence to prove that the sitters for Resident # 4 were medically necessary.

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7. Immediate jeopardy

The term “immediate jeopardy” means noncompliance that is so egregious as to cause or be likely to cause serious injury, impairment, harm, or death to a resident. 42 C.F.R. § 488.301. Where noncompliance is established, as is true in this case, a finding of immediate jeopardy must be sustained unless proven to be clearly erroneous. Liberty Common Nursing & Rehab Ctr. – Johnston, DAB No. 2031 at 18-19 (2006), aff’d, Liberty Commons Nursing & Rehab Ctr. – Johnston v. Leavitt, 241 F.App’x 76 (4th Cir. 2007).

Petitioner’s noncompliance is a textbook example of immediate jeopardy level noncompliance. As I have discussed, Covid is not just deadly to elderly and infirm individuals, precisely those who reside in skilled nursing facilities, but it is extremely contagious. Once Covid penetrates a facility’s premises, it is a likely death sentence for at least some residents. In this case, Petitioner’s noncompliance certainly facilitated the spread of Covid. Its failure to cohort residents who were of unknown Covid status from those who were uninfected increased the likelihood that unexposed residents would contract the disease. Its failure to immediately isolate a Covid-positive resident from that resident’s roommate meant that the roommate would likely be exposed to the disease and be at risk for the consequences of exposure. It also increased the risk that the disease would spread, not just from the resident originally infected, but from that resident’s roommate.

Petitioner’s failure to report suspected cases of Covid also endangered residents because it meant that state authorities were kept in the dark about problems that existed at Petitioner’s facility. Its failures to ensure that staff had access to PPE, that they understood the conditions for wearing PPE, and that they wore PPE properly, increased the risk of spread of Covid, not just among the staff, but from staff to residents and vice versa. Finally, Petitioner’s blatant failure to enforce its visitation policy greatly increased the likelihood that Covid would enter the facility. These failures, individually and collectively, put residents at a likelihood of harm or death.

Petitioner contends that there was no serious outcome or even a likelihood of serious outcome from its noncompliance. Petitioner’s brief at 22. As justification for this, Petitioner contends that CMS does not allege that Petitioner’s actions resulted in the spread of Covid. However, it is not necessary that CMS prove that any resident at Petitioner’s facility contracted Covid as a direct consequence of Petitioner’s noncompliance. It is enough in this case to say that Petitioner opened its doors to the entry and spread of Covid with its failure to comply with federal and state guidelines and its own infection control plan. Covid is a deadly disease. Any failure by Petitioner to apply its policies rigorously and that increased the risk of spread suffices to establish immediate jeopardy level noncompliance.

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Petitioner also contends that there could not be immediate jeopardy level noncompliance because there was no remedial action that Petitioner needed to take. Petitioner’s brief at 23. The premise underlying this contention is that Petitioner was, in fact, complying with infection control requirements. Therefore, in Petitioner’s eyes, there was nothing that it needed to correct. I have explained in detail why this assertion is wrong. I need not revisit Petitioner’s multiple failures to comply.

8. Remedies

CMS imposed three remedies against Petitioner. These consisted of:  civil money penalties of $8,995 for each day of the period beginning on November 10, 2020 and continuing through November 18, 2020, when immediate jeopardy level noncompliance occurred at Petitioner’s facility; civil money penalties of $330 per day for each day of the period beginning on November 19, 2020 and continuing through January 24, 2021, when noncompliance continued, albeit at a level that was less than immediate jeopardy; and denial of payment for new Medicare admissions for each day of the period beginning December 23, 2020 and running through January 24, 2021.

Petitioner has not specifically challenged either the duration or the amount of the civil money penalties, nor has it challenged CMS’s authority to impose the remedy of denial of payment for new admissions except to dispute the existence of noncompliance.

All three remedies are permitted by regulation. The immediate jeopardy level and non immediate jeopardy level civil money penalties fall well within the prescribed ranges for such penalties. 42 C.F.R. § 488.438(a)(i),(ii); 45 C.F.R. § 102.3. Indeed, these penalties are quite modest. The immediate jeopardy level penalties are less than half the maximum daily allowable amount and the non-immediate jeopardy level penalties are but a small fraction of the maximum daily allowable amount. The remedy of denial of payment for new admissions may be imposed to remedy any level of noncompliance that is substantial. 42 C.F.R. § 488.408(d).

Regulations prescribe factors to be used to decide the reasonableness of civil money penalties. 42 C.F.R. §§ 488.488(f)(1)-(4), 488.404 (incorporated by reference into 42 C.F.R. § 488.438(f)(3)). These factors include the seriousness of a facility’s noncompliance.

I find that the seriousness of Petitioner’s noncompliance amply justifies the remedies that CMS determined to impose. I view Petitioner’s noncompliance in the light of the deadliness of Covid in a skilled nursing facility setting and its ease of spread. Here, Petitioner’s failure to follow applicable policies and to implement its own infection control plan provided avenues for Covid to spread among its residents, putting those

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residents at risk of harm and death.

 

1. I base my findings in this decision on the regulation that was in effect during November and December 2020 and January 2021.
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2. Petitioner contends that parts of these allegations were found to be unsupported in a state independent dispute resolution (IDR) proceeding. However, CMS is not bound by the results of IDR. I evaluate the evidence independently and my findings here are supported by the evidence that I cite.
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3. In their declarations Mr. Davis and Mr. Henderson state, in identical language, that “Staff interviews conducted after the survey . . . confirm that the surveyor’s observations regarding proper use of PPE were incorrect.” P. Ex. 41 at 2; P. Ex. 42 at 2. These assertions are hearsay and are of no probative value, not the least because they attribute statements to unnamed individuals who Petitioner did not call as witnesses, but also because Petitioner offered no record of these purported interviews.
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