Twin Pines Nursing and Rehabilitation Center, CR6313 (2023)

DECISION

I sustain the determination of the Centers for Medicare & Medicaid Services (CMS) to impose remedies against Petitioner, Twin Pines Nursing and Rehabilitation Center, consisting of the following civil money penalties:

• $8,830 for each day of a period that began on July 19, 2020, and that continued through July 25, 2020, and;
• $110 per day for each day of a period that began on July 26, 2020, and that continued through August 19, 2020.

I.     Background

This case was originally assigned to another administrative law judge.  It was transferred recently to my docket.

The parties agreed that the case could be heard based on their written exchanges without in-person cross-examination of witnesses whose testimony is filed in affidavit or declaration form.  I did not schedule an in-person hearing for that reason.

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Each party filed an opening brief and a closing brief.  CMS filed exhibits in support of its allegations, identified as CMS Ex. 1-CMS Ex. 30.  Petitioner filed exhibits identified as P. Ex. 1-P. Ex. 34.  Petitioner objected to my receiving some of CMS’s exhibits.  I overruled those objections.  I receive all the parties’ exhibits into evidence.

II.     Issues, Findings of Fact and Conclusions of Law

A. Issues

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

B. Findings of Fact and Conclusions of Law

CMS alleges that Petitioner failed to comply substantially with several Medicare participation requirements.  However, its case against Petitioner – and its remedy determination – relate to allegations that Petitioner failed to comply substantially with a single regulation, 42 C.F.R. § 483.80(a)(1).  I find it unnecessary that I address additional noncompliance allegations to decide this case.

1. Noncompliance

The applicable regulation governs a skilled nursing facility’s infection prevention control policy and procedures.  It directs a Medicare-participating skilled nursing facility to establish and maintain an infection prevention and control program that is designed to provide a safe, sanitary, comfortable environment and to help prevent the development and transmission of communicable diseases and infections.  42 C.F.R. § 483.80.  A facility’s infection prevention and control program must include a system for preventing, identifying, reporting, investigating, and controlling infections.  42 C.F.R. § 483.80(a).  At a minimum, that system must apply to all residents, staff, volunteers, visitors, and other individuals providing services within a facility.

A facility’s infection prevention and control policy must comport with accepted national standards.  42 C.F.R. § 483.80(a)(1).  Those standards may change as health professionals learn about an illness, its infectiousness, and the steps that must be taken to combat it.  A facility must reassess its policy and modify it to comport with changing conditions and evolving professional standards of care.  Golden Living Ctr. – Superior, DAB No. 2768 at 4, 21-22 (2017).

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CMS’s noncompliance allegations relate to a period during the summer of 2020 when Covid-19 (“Covid”) ran rampant through our society and skilled nursing facilities.  Covid is an infectious virus that is easily transmissible from infected to non-infected individuals via exhaled virus particles.  CMS Ex. 23 at 2.  It can be lethal, especially among older individuals with underlying medical conditions, precisely the typical skilled nursing facility census.  CMS Ex. 27 at 1.

Petitioner experienced a massive Covid infection outbreak at its facility during the summer of 2020.  On July 14, 2020, test results showed that 50 of Petitioner’s residents and 40 of its staff were infected.  CMS Ex. 1 at 54; CMS Ex. 6; CMS Ex. 8.

CMS contends that Petitioner failed to implement its infection prevention and control policy.  It asserts that Petitioner failed to comply with national Covid prevention directives issued by the Centers for Disease Control (CDC) and Petitioner’s own guidelines for infection control.

Specifically, CMS contends that Petitioner’s staff often failed to utilize personal protective equipment (PPE) appropriately, citing ten instances in which surveyors observed Petitioner’s staff either not wearing required equipment or wearing it improperly.  CMS contends further that Petitioner allowed Covid-infected staff to provide care for Covid-negative residents.  Finally, CMS asserts that Petitioner’s staff failed to socially distance vulnerable residents.

The evidence CMS relies on to support its allegations of noncompliance is largely undisputed.  This evidence amply supports CMS’s allegations.

a. Failure by staff to wear PPE appropriately

Petitioner adopted a general infection prevention and control policy and subsequent policies that dealt specifically with Covid.  Petitioner’s policies incorporate CDC guidelines.  CMS Ex. 18.  They do so generally and in some respects explicitly:  for example, Petitioner’s policies require expressly that PPE be utilized by staff as per CDC guidelines.  Id.; CMS Ex. 21 at 2.

CDC guidelines in effect during the summer of 2020 directed that staff utilize PPE during the duration of their work in potentially contaminated areas.  CMS Ex. 25.  The CDC defined appropriate PPE to include a respirator, a gown, gloves, and eye protection.  CMS Ex. 23 at 6; CMS Ex. 25.

Petitioner’s staff often failed to comply with CDC guidelines.  From July 17 through July 21, 2020, a surveyor observed ten instances of noncompliance.  Observations on July 17 included:  a housekeeper cleaning residents’ rooms in a part of the facility that housed infected residents (hot zone) without appropriately wearing eye protection and without

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gloves; an assistant director of nursing not wearing eye protection in the hot zone; a nursing assistant not wearing eye protection while entering a resident’s room in the hot zone; another nursing assistant entering and exiting a resident’s room while not appropriately wearing eye protection; and a housekeeper cleaning residents’ rooms while the residents were present, while not wearing eye protection.  CMS Ex. 1 at 63-65; CMS Ex. 15 at 2.

On July 19, 2020, a surveyor observed Petitioner’s director of nursing and its administrator together in the director of nursing’s office on multiple occasions.  The two individuals were not socially distanced nor were they wearing masks when they were together.  CMS Ex. 1 at 65-67; CMS Ex. 15 at 13.  The surveyor also observed a laundry staff member not wearing a mask while in Petitioner’s laundry room with another staff member.  Ids.  Additionally, the surveyor observed two staff members – each having tested positive for Covid infection – improperly wearing PPE.  These individuals consisted of Petitioner’s admissions coordinator, observed in a part of the facility reserved for uninfected residents (cold zone), walking with the bottom straps of her mask unfastened, and a dietary aide, preparing sandwiches for residents with her nose uncovered.  Ids.

On July 21, 2020, a surveyor observed Petitioner’s assistant director of nursing not wearing eye protection while providing medication to infected residents in Petitioner’s hot zone.  CMS Ex. 1 at 67-68.

There were real dangers associated with these violations of CDC guidelines and Petitioner’s infection prevention and control policies.  Staff not wearing PPE appropriately could have become infected with Covid.  Becoming infected, they could have transmitted the disease to other staff members or to residents.  Moreover, the multiple incidents of staff transgressions are compelling evidence of a problem at Petitioner’s facility that exceeded the sum of the parts.  There was a generalized laxness by Petitioner’s staff in complying with CDC guidelines and Petitioner’s policies.  The inference that I draw – entirely reasonable given the large number of documented violations of guidelines and policies – is that many members of Petitioner’s staff were either poorly trained in the use of PPE or were indifferent to the requirements concerning the use of that equipment.

Petitioner does not contest the surveyors’ observations.  It offers defenses that assume the observations to be correct.  I find these defenses to be unpersuasive.

First, Petitioner raises a general defense that in the summer of 2020, CDC guidelines were constantly changing, confusing, and impossible to implement.  Petitioner’s Closing Brief at 3-4.  Petitioner contends also that CDC policy “often was in conflict with guidance issued by state and local officials.” Id. at 3.  Moreover, according to Petitioner, CDC guidelines were mere “guidance” that had no legal effect.  Id. at 4.

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CDC guidelines evolved as the pandemic progressed and that evolution reflected experts’ changing understanding of Covid’s infectiousness based on accumulating evidence.  But the issue here is whether Petitioner complied with the guidelines in effect as of July 2020, and not whether it complied with prior or subsequent guidelines that the CDC may have modified or rescinded.  Petitioner has pointed to nothing in the CDC guidelines that was confusing as of July 2020, nor has it disputed CMS’s assertion that the guidelines required staff to wear certain PPE articles – a respirator, a gown, gloves, and eye protection – when treating Covid-positive residents or while in potentially contaminated areas of the facility.  CMS Ex. 23 at 6; CMS Ex. 25.

Nor has Petitioner identified anything in CDC guidelines addressing the wearing of PPE that conflicts with state or local policy.

Finally, the issue is not whether CDC guidelines had the force of law.  The guidelines were not laws or regulations, but they were national standards that Petitioner had to comply with.  42 C.F.R. § 483.80(a)(1).  Petitioner’s own infection prevention and control policies mandated that its staff adhere to current CDC guidelines governing the wearing of PPE.  CMS Ex. 21 at 2.

Petitioner argues that “nearly all” of the observations of improper use of PPE by staff were made in Petitioner’s hot zone housing infected residents.  Petitioner’s Closing Brief at 5.  Petitioner evidently suggests that no harm could result from staff’s laxness in the hot zone because residents there already had Covid.  But that assertion ignores the likelihood that infected residents would transmit the disease to uninfected staff who were not properly utilizing PPE and that the staff could then infect other members of the staff or uninfected residents.¹

Petitioner argues that “most of the staff” observed by surveyors were wearing PPE appropriately or that they were doing so “with the exception of a single element – i.e., lacking eye protection, or a mask pulled down.” Petitioner’s Closing Brief at 5.  But, in this case, mostly appropriately isn’t a passing grade.  The infectiousness of Covid makes it imperative that staff comply scrupulously with CDC guidelines governing the wearing of PPE – there is no such thing as close enough.  Furthermore, the undisputed fact that some of Petitioner’s staff were not wearing PPE appropriately meant that there were at least a few possible infection vectors circulating through Petitioner’s facility.

Petitioner also seeks to minimize the likely hazards associated with staff not properly wearing PPE by contending that some of the staff were not in contact with residents and

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therefore posed no risk of harm to them.  Petitioner’s Closing Brief at 5.  Such staff, according to Petitioner, included kitchen and laundry room staff.

With respect to the kitchen staff Petitioner asserts that everyone involved was already Covid positive, apparently suggesting that its entire kitchen staff was infected when they were observed by surveyors.  But Petitioner has not offered proof that this was so.  Petitioner also did not prove that uninfected individuals may have entered Petitioner’s kitchen from time to time.  In that event, the uninfected could be infected by staff not wearing PPE appropriately.  Nor did Petitioner prove that its kitchen and laundry staff never associated with residents.  The obvious inference that I draw from the evidence is that if kitchen and laundry staff were not wearing PPE appropriately when they were working in the kitchen and laundry room, it is likely that they were not wearing it appropriately while they were elsewhere in Petitioner’s facility.

Petitioner asserts that no harm could result from its administrator and director of nursing meeting unmasked in close quarters because they had been working together consistently since Covid entered Petitioner’s facility and, therefore, had likely already infected each other by July 2020.  Petitioner’s Closing Brief at 5-6.  Petitioner offered no proof for that assertion.  Petitioner argues additionally that the meetings between the director of nursing and Petitioner’s administrator took place behind closed doors, thereby eliminating the risk that these two individuals could spread Covid.  Id. at 6.  But those two individuals weren’t always behind closed doors.  If one individual infected the other when meeting behind closed doors that created a likelihood that the newly infected person would transmit Covid to other individuals as that person circulated throughout Petitioner’s facility.

Finally, Petitioner contends that by July 2020 Covid was known to be primarily a respiratory infection.  Therefore, according to Petitioner, it was “more important that staff were wearing face coverings” than that they wore eye protection.  Petitioner’s Closing Brief at 6.

But CDC guidelines – accepted as governing requirements by Petitioner – required eye protection as of July 2020.  Petitioner has not offered proof to show that the CDC policy respecting eye wear was incorrect.  Whether Covid primarily is transmitted by inhaled particles does not exclude the possibility – accepted by the CDC in July 2020 – that it could be transmitted in other ways.

b. Allowing Covid-positive staff to interact with Covid-negative residents

The wave of infections sweeping through Petitioner’s facility in July 2020 put great pressure on staff and management.  As of July 14, 2020, forty of Petitioner’s staff members, tested positive for Covid.  P. Ex. 7 at 3.  These forty staff members, along with

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an additional 17 staff members already out because of Covid-related quarantining, resulted in at least a 35% staffing loss.  Id.

That left Petitioner’s management scrambling to find staff who could provide care to residents.  In mid-July 2020 management sought staff from affiliated facilities and staffing agencies, and requested assistance from local government, largely without success.  Id.

CDC guidelines indicating “[r]ecent changes as of April 30, 2020,” discussed what facilities should do when confronted with the issue of Covid-positive staff and concomitant staffing shortages.  The guidelines addressed return to work of staff with suspected or confirmed Covid infections and provided strategies to mitigate healthcare personnel staffing shortages.  P. Ex. 4; P. Ex. 34.

Generally, the guidelines prohibited Covid-positive staff from working.  The guidelines stated that, if a facility utilized test results to decide when infected employees could return to work, then staff who tested positive for Covid should be excluded from work until they met all Covid testing criteria for return to work.  P. Ex. 34 at 2.  The guidelines stated additionally that Covid-positive staff should be excluded from work until staff became asymptomatic and produced negative tests (using acceptable methodology) on at least two consecutive occasions spaced at least 24 hours apart.  P. Ex. 4 at 2.

However, CDC guidelines also recognized that there might be situations – defined as continuing staffing shortages that persisted despite efforts to alleviate them – where staff with suspected or confirmed Covid infections and who were well enough to work could return to work.  P. Ex. 34 at 2.  The guidelines stated that Covid-positive staff who were allowed to return to work should be restricted from contact with severely immunocompromised patients.  The guidelines instructed facilities to prioritize returning Covid-positive staff’s duties according to the facilities’ need for staff, and in the following order:

1. Employing Covid-positive staff in jobs where they did not interact with other staff or facility residents;
2. Utilizing Covid-positive staff to provide direct care only for facility residents with confirmed Covid, and preferably in a cohort setting (where Covid-positive residents are segregated from Covid-negative residents);
3. Allowing Covid-positive staff to provide direct care with residents who are suspected as having been infected with Covid;
4. As a last resort, allowing Covid-positive staff to provide direct care for patients without suspected or confirmed Covid infections.

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Id. at 2-3.

Petitioner recalled several of its Covid-positive employees to work to alleviate the staffing shortages at its facility.  Petitioner assigned some staff members – all of whom had tested positive for Covid – to provide care to residents who were either Covid-negative or who had been exposed to Covid but who had not tested positive for the disease.  CMS Ex. 1 at 55-56; CMS Ex. 13 at 5-6.

I do not fault Petitioner for bringing back to work some of its Covid-positive staff.  The evidence shows that Petitioner had a severe staffing shortage.  But there is no evidence that Petitioner systematically applied CDC strategies to mitigate staffing shortages.  There is nothing in the record that establishes that Petitioner prioritized its staff’s duties to minimize contact between Covid-positive staff and Covid-negative staff or residents.  There is nothing to show that Petitioner considered using its returning Covid-positive staff as caregivers for Covid-negative residents only as a last resort.

When questioned by a surveyor, Petitioner’s director of nursing was unaware that Covid-positive staff were providing care to Covid-negative residents.  CMS Ex. 1 at 45; CMS Ex. 15 at 10.  I infer from this lack of knowledge that Petitioner’s management did not attempt to assign returned but still Covid-positive staff in accord with CDC criteria.  I conclude that Petitioner’s management told Covid-positive staff to resume their regular work assignments without regard to CDC prioritization criteria.

Thus, while alleviating a staff shortage with Covid-positive staff may have been permissible given Petitioner’s staffing shortage, Petitioner did not justify assigning Covid-positive staff members to provide care to Covid-negative residents.

Petitioner argues that it allowed its Covid-positive staffers to return to work only as a last resort.  Petitioner’s Closing Brief at 7.  It contends that it implemented CDC strategies to mitigate staffing shortages, characterizing these strategies as permitting:

[S]taff with confirmed Covid-19 to work, as long as they wear appropriate PPE, restrict contact with severely immune compromised residents, and self-monitor for symptoms.

Id.  This assertion misstates CDC criteria because it omits the CDC’s priorities for allowing Covid-positive staff to return to work.  As I have stated, Petitioner may have been justified in bringing back some of its Covid-positive staff.  But assigning Covid-positive staff to provide care for Covid-negative residents was not permitted by CDC criteria except as an absolute last resort, a criterion that Petitioner did not prove that it met.

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Petitioner contends that even if returning staff tested positive for Covid, that did not necessarily mean that they could infect other staff and residents.  Petitioner asserts that it was therefore justified in returning its employees to work even if they continued to test positive.  Petitioner’s Closing Brief at 7.  It argues that three of its certified nursing assistants were cleared to return to work after they had been infected for 14 days and “almost certainly were not contagious.” Id.  As support for this assertion, Petitioner cites CDC guidelines that acknowledge reports of individuals continuing to test positive for Covid even after they were no longer capable of transmitting the disease.  P. Ex. 4 at 1.

Petitioner brought back more than only three of its Covid-positive staff.  It returned several additional Covid-positive staff members to work.  That three of these employees possibly were no longer capable of transmitting the virus says nothing about the status of other employees that Petitioner brought back to its facility.  Petitioner does not contend that those other employees were no longer infectious.

Moreover, Petitioner has offered no proof to show that the three returned Covid-positive nursing assistants were incapable of transmitting the disease.  Indeed, Petitioner avers only that it was highly unlikely that they could do so.  The fact that these staff members continued to test positive imposed on Petitioner a duty to exclude them from treating Covid-negative residents except as a last resort.  But Petitioner allowed these staff members to interact with Covid-negative residents without justifying that decision.

Petitioner contends that CMS’s allegations of noncompliance “are a prime example of how nursing facilities were not provided with notice of the standards to which they would be held accountable in June and July 2020.” Petitioner’s Closing Brief at 8.  I disagree.  Petitioner maintained the CDC criteria for returning Covid-positive staffers to work as part of its own records.  P. Ex. 4; P. Ex. 34.  Those criteria aren’t vague or ambiguous, they are clear on their face.  Petitioner simply failed to comply with them.

c. Failure to ensure that residents were socially distanced

Petitioner’s policy directed its staff to perform appropriate social distancing of residents as a safeguard against Covid transmission.  That policy was consistent with CDC guidelines that directed facilities to enforce social distancing among residents and to cancel communal dining.  CMS Ex. 24 at 1.  Neither Petitioner’s policy nor CDC guidelines define what is meant by “social distancing.” I infer that the term means separating residents by a sufficient distance to preclude the airborne spread of infectious matter.

Petitioner failed to comply with its policy or with CDC guidelines.  On July 19, 2020, a surveyor observed two severely cognitively impaired residents eating breakfast together while seated at the same table.  CMS Ex. 15 at 16.

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Petitioner argues that CMS did not substantiate its assertion that the residents were seated together.  Petitioner’s Closing Brief at 9.  It contends that there is a failure of proof by CMS because the surveyor did not specifically identify the two residents.  Id.

I find this argument to be unpersuasive.  The surveyor’s findings are the product of eyewitness observation.  The surveyor did not have to identify the residents by name to verify that these two residents were not socially distanced.

Petitioner argues also that CMS fails to consider that the two residents in question are severely cognitively impaired.  Petitioner’s Closing Brief at 9.  It contends that maintaining social distancing is difficult for a person with severe cognitive impairments.  Id.

That may be true, but it does not excuse Petitioner’s failure to assure that the two residents maintained a safe distance between them.  There is nothing in the record to show that staff could not have seated the two residents a safe distance apart or that staff could not have separated them if the residents approached each other too closely.  Indeed, on July 19, 2020, after the surveyor observed the two residents sitting close to each other, a staff member asked them to separate and one of the residents obliged by moving.  CMS Ex. 15 at 16.

2. Immediate Jeopardy

The term “immediate jeopardy” is defined as noncompliance that is so egregious as to cause, or is likely to cause, a resident or residents to experience serious injury, harm, impairment, or death.  42 C.F.R. § 488.301.  CMS determined that Petitioner’s noncompliance with 42 C.F.R. § 483.80(a)(1) was at the immediate jeopardy level.  Petitioner challenges that determination.

In challenging an immediate jeopardy determination, the burden falls on the facility to prove that the determination is clearly erroneous.  42 C.F.R. § 498.60(c)(2).

Petitioner did not meet that heavy burden of proof.

CMS provided evidence to show that Petitioner’s failures to comply with its own infection prevention and control policy and with CDC guidelines created a likelihood that infection would spread within Petitioner’s facility.  Evidence establishes that there was a systemic failure by Petitioner’s staff to utilize PPE appropriately.  Petitioner’s management allowed Covid-positive staff to return to work without implementing safeguards to assure that Covid-negative residents would not be put at risk by encountering this staff, again in violation of CDC policy.  Petitioner’s staff violated Petitioner’s policy and CDC guidelines by allowing residents to sit close to each other.

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The CDC did not write its guidelines in a vacuum.  These guidelines were created as a comprehensive effort to mitigate the spread of Covid within healthcare facilities.  The CDC determined that the criteria and policies embodied in its guidelines were necessary to combat a virulent and highly contagious illness.  Axiomatically, the failure by a facility to follow the guidelines meant that it tolerated conditions that increased the likelihood of spreading Covid.

The failures by Petitioner’s management and staff and their likely effect on residents’ health and safety must be considered in light of the lethality of Covid in nursing facilities.  I take notice that as of June 2020, up to 40 percent of Covid deaths in the United States were among nursing facility residents.²

Petitioner denies that it was noncompliant but avers that, if it was noncompliant, the elements of immediate jeopardy were not present at its facility.  Petitioner’s Closing Brief at 10.  It offers no evidence or analysis to support this conclusion.  That is not enough to prove CMS’s determination to be clearly erroneous.

3. Remedies

CMS imposed a civil money penalty of $8,830 for each day of the period beginning on July 19, 2020, and continuing through July 25, 2020, during which it determined Petitioner to be noncompliant at the immediate jeopardy level.  It imposed a civil money penalty of $110 for each day of the period beginning on July 26, 2020, and running through August 19, 2020, during which it determined Petitioner remained noncompliant, albeit at a level that is less than immediate jeopardy.  I find these penalties to be reasonable in amount and duration.

Regulations establish that per diem civil money penalties, such as those imposed here, fall within ranges of permissible amounts depending on whether a facility’s noncompliance is at the immediate jeopardy level.  42 C.F.R. § 488.438(a)(1)(i), (ii).  The penalties that CMS imposed against Petitioner fall at the lower ends of their respective ranges.  Ids.; 45 C.F.R. Part 102.

Regulatory criteria apply to deciding whether a civil money penalty amount is reasonable.  The criteria include the seriousness of a facility’s noncompliance, its compliance history, its culpability, and its financial condition.  42 C.F.R. §§ 488.438(f)(1)-(4), 488.404 (incorporated by reference into 42 C.F.R. § 488.438(f)(3)).

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I find the seriousness of Petitioner’s noncompliance justifies the penalties that CMS determined to impose.  As I have discussed, Covid is frequently lethal among aged and infirm individuals – precisely the individuals who are housed in skilled nursing facilities.  Even the slightest failure by a facility to scrupulously enforce its infection prevention and control policies in the face of a Covid infection may result in the death of one or more residents in that facility.  Petitioner’s noncompliance with its infection prevention and control policies opened the door for additional infections within its facility.  The lower-end penalties that CMS determined to impose are quite modest when measured against the likelihood of harm caused by Petitioner’s noncompliance.

In its pre-hearing brief Petitioner contended that it would show that the penalty amounts and duration of noncompliance determined by CMS were unreasonable.  Petitioner’s Prehearing Brief at 25.  However, Petitioner did not follow through with either evidence or argument to challenge CMS’s remedy determinations.

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Endnotes

¹ Petitioner seems to suggest – without stating so explicitly – that the only staff members entering Petitioner’s hot zone were already infected with Covid, claiming that “everyone involved already had the virus.” Petitioner’s Closing Brief at 5.  However, Petitioner has not offered proof that this was so.

² See Nursing homes site of 40% of US COVID-19 deaths, https://www.cidrap.umn.edu/covid-19/nursing-homes-site-40-us-covid-19-deaths (last visited July 5, 2023).